id|nct_id|ctgov_group_code|result_type|title|description
1|NCT02987374|B1|Baseline|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
2|NCT02987374|P1|Participant Flow|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
3|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
4|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
5|NCT02987374|E1|Reported Event|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
6|NCT02958956|B3|Baseline|Total|Total of all reporting groups
7|NCT02958956|B2|Baseline|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
8|NCT02958956|B1|Baseline|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
9|NCT02958956|P2|Participant Flow|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
10|NCT02958956|P1|Participant Flow|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
11|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
12|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
13|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
14|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
15|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
16|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
17|NCT02958956|O2|Outcome|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
18|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
19|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
20|NCT02958956|E2|Reported Event|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
21|NCT02958956|E1|Reported Event|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
22|NCT02920749|B5|Baseline|Total|Total of all reporting groups
23|NCT02920749|B4|Baseline|Group D|Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
24|NCT02920749|B3|Baseline|Group C|General anaesthesia was maintained with propofol.
25|NCT02920749|B2|Baseline|Group B|Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
26|NCT02920749|B1|Baseline|Group A|General anaesthesia was maintained with sevoflurane.
27|NCT02920749|P4|Participant Flow|Group D|In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
28|NCT02920749|P3|Participant Flow|Group C|Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
29|NCT02920749|P2|Participant Flow|Group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
30|NCT02920749|P1|Participant Flow|Group A|Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
63|NCT02862106|B5|Baseline|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
31|NCT02920749|O4|Outcome|Group D|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
32|NCT02920749|O3|Outcome|Group C|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
33|NCT02920749|O2|Outcome|Group B|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
34|NCT02920749|O1|Outcome|Group A|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
35|NCT02920749|O4|Outcome|Group D|Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
36|NCT02920749|O3|Outcome|Group C|Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
37|NCT02920749|O2|Outcome|Group B|Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
38|NCT02920749|O1|Outcome|Group A|Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
39|NCT02920749|E4|Reported Event|Group D|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
40|NCT02920749|E3|Reported Event|Group C|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
41|NCT02920749|E2|Reported Event|Group B|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
42|NCT02920749|E1|Reported Event|Group A|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
43|NCT02919657|B1|Baseline|All Participants|All participants were given a baseline blood analysis
44|NCT02919657|P2|Participant Flow|Whey Protein Isolate Then Genepro Gen2 Protein|"30g Serving of Whey Isolate Protein will be used daily in each subject.~1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject."
45|NCT02919657|P1|Participant Flow|Genepro Gen2 Protein Then Whey Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~30g Serving of Whey Isolate Protein will be used daily in each subject."
46|NCT02919657|O2|Outcome|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
47|NCT02919657|O1|Outcome|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
48|NCT02919657|E2|Reported Event|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
49|NCT02919657|E1|Reported Event|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
50|NCT02882152|B3|Baseline|Total|Total of all reporting groups
51|NCT02882152|B2|Baseline|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
52|NCT02882152|B1|Baseline|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
53|NCT02882152|P2|Participant Flow|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
54|NCT02882152|P1|Participant Flow|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
55|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
56|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
57|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
58|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
59|NCT02882152|E2|Reported Event|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
60|NCT02882152|E1|Reported Event|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
61|NCT02862106|B7|Baseline|Total|Total of all reporting groups
62|NCT02862106|B6|Baseline|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
230|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
64|NCT02862106|B4|Baseline|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
65|NCT02862106|B3|Baseline|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
66|NCT02862106|B2|Baseline|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
67|NCT02862106|B1|Baseline|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
68|NCT02862106|P2|Participant Flow|Follow-up Group|Do not give any intervention, follow-up observation only
69|NCT02862106|P1|Participant Flow|εPA-44 900μg|"Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128~εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128"
70|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
71|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
72|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
73|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
74|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
75|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
76|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
77|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
78|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
79|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
80|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
81|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
82|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
83|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
84|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
85|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
86|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
87|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
88|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
89|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
90|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
91|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
92|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
93|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
94|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
95|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
96|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
97|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
98|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
99|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
154|NCT02839772|O1|Outcome|Number of Wounds at Baseline|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.
100|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
101|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
102|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
103|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
104|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
105|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
106|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
107|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
108|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
109|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
110|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
111|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
112|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
113|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
114|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
115|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
116|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
117|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
118|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
119|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
120|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
121|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
122|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
123|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
124|NCT02862106|E2|Reported Event|εPA-44 900μg Group|Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
125|NCT02862106|E1|Reported Event|Follow-up Group|Do not give any intervention, follow-up observation only
126|NCT02840916|B3|Baseline|Total|Total of all reporting groups
127|NCT02840916|B2|Baseline|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
128|NCT02840916|B1|Baseline|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
129|NCT02840916|P2|Participant Flow|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
130|NCT02840916|P1|Participant Flow|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
131|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
155|NCT02839772|O2|Outcome|Participants With Bad Odour From Legs/Feet at 4th Visit|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
416|NCT02792049|B3|Baseline|Total|Total of all reporting groups
132|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
133|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
134|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
135|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
136|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
137|NCT02840916|E2|Reported Event|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
138|NCT02840916|E1|Reported Event|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
139|NCT02839772|B3|Baseline|Total|Total of all reporting groups
140|NCT02839772|B2|Baseline|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
141|NCT02839772|B1|Baseline|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
142|NCT02839772|P2|Participant Flow|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
143|NCT02839772|P1|Participant Flow|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
144|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
145|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
146|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
147|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
148|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
149|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
150|NCT02839772|O1|Outcome|Correlation Between Number of Wounds and Days Lost Due to ADL|Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
151|NCT02839772|O2|Outcome|Number of Days Lost by All Participants at 4th Visit|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
152|NCT02839772|O1|Outcome|Number of Days Work Days Lost by All Participants Baseline|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
153|NCT02839772|O2|Outcome|Number of Wounds 4th Visit|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
156|NCT02839772|O1|Outcome|Participants With Bad Odour From Legs/Feet at Baseline|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
157|NCT02839772|O2|Outcome|Total Number of Trophic Skin Changes at 4th Visit|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
158|NCT02839772|O1|Outcome|Total Number of Trophic Skin Changes at Baseline|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.
159|NCT02839772|O2|Outcome|Stage of Podoconiosis 4th Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
160|NCT02839772|O1|Outcome|Stage of Podoconiosis 1st Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
161|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
162|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
163|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
164|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
165|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
166|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
167|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
168|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
169|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
170|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
171|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
172|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
173|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
174|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
175|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
176|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
177|NCT02839772|E2|Reported Event|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
178|NCT02839772|E1|Reported Event|Control Group|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
229|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
179|NCT02829775|B1|Baseline|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
180|NCT02829775|P1|Participant Flow|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
181|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
182|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
183|NCT02829775|E1|Reported Event|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
184|NCT02829463|B3|Baseline|Total|Total of all reporting groups
185|NCT02829463|B2|Baseline|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
186|NCT02829463|B1|Baseline|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
187|NCT02829463|P2|Participant Flow|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
188|NCT02829463|P1|Participant Flow|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
189|NCT02829463|O2|Outcome|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
190|NCT02829463|O1|Outcome|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
191|NCT02829463|E2|Reported Event|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
192|NCT02829463|E1|Reported Event|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
193|NCT02828137|B4|Baseline|Total|Total of all reporting groups
194|NCT02828137|B3|Baseline|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
195|NCT02828137|B2|Baseline|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
196|NCT02828137|B1|Baseline|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
197|NCT02828137|P3|Participant Flow|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
198|NCT02828137|P2|Participant Flow|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
199|NCT02828137|P1|Participant Flow|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
200|NCT02828137|O3|Outcome|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
201|NCT02828137|O2|Outcome|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73
202|NCT02828137|O1|Outcome|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87
203|NCT02828137|E3|Reported Event|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
204|NCT02828137|E2|Reported Event|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
205|NCT02828137|E1|Reported Event|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
206|NCT02823080|B3|Baseline|Total|Total of all reporting groups
72790|NCT01736475|O2|Outcome|On-demand|
207|NCT02823080|B2|Baseline|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
208|NCT02823080|B1|Baseline|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
209|NCT02823080|P2|Participant Flow|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
210|NCT02823080|P1|Participant Flow|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
211|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
212|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
213|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
214|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
215|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
216|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
217|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
218|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
219|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
220|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
221|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
222|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
223|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
224|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
225|NCT02823080|E2|Reported Event|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
226|NCT02823080|E1|Reported Event|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
227|NCT02822287|B1|Baseline|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
228|NCT02822287|P1|Participant Flow|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
231|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
232|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
233|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
234|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
235|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
236|NCT02822287|E1|Reported Event|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
237|NCT02809911|B3|Baseline|Total|Total of all reporting groups
238|NCT02809911|B2|Baseline|Active Provant|"Active Provant Treatment~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
239|NCT02809911|B1|Baseline|Sham of Provant|"Sham of Provant Therapy System~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
240|NCT02809911|P2|Participant Flow|Active Provant|"Active Provant Treatment~Provant"
241|NCT02809911|P1|Participant Flow|Sham of Provant|"Sham of Provant Therapy System~Provant"
242|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
243|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
244|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
245|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
246|NCT02809911|E2|Reported Event|Active Provant|"Active Provant Treatment~Provant"
247|NCT02809911|E1|Reported Event|Sham of Provant|"Sham of Provant Therapy System~Provant"
248|NCT02809833|B1|Baseline|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
249|NCT02809833|P1|Participant Flow|Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
250|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
251|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
252|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
253|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
254|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
255|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
256|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
257|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
258|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
506|NCT02773758|B3|Baseline|Total|Total of all reporting groups
72791|NCT01736475|O1|Outcome|Prophylaxis|
259|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
260|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
261|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
262|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
263|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
264|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
265|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
266|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
267|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
268|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
269|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
270|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
271|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
272|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
273|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
274|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
275|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
276|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
277|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
278|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
279|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
280|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
281|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
282|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
283|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
284|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
285|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
286|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
287|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
288|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
289|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
290|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
291|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
292|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
293|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
294|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
295|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
296|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
297|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
298|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
299|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
300|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
301|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
302|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
303|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
304|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
305|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
306|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
307|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
308|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
309|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
310|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
311|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
312|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
313|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
314|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
315|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
316|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
317|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
318|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
319|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
320|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
321|NCT02809833|E1|Reported Event|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
322|NCT02808130|B7|Baseline|Total|Total of all reporting groups
323|NCT02808130|B6|Baseline|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
324|NCT02808130|B5|Baseline|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
325|NCT02808130|B4|Baseline|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
326|NCT02808130|B3|Baseline|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
72792|NCT01736475|O2|Outcome|On-demand|
327|NCT02808130|B2|Baseline|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
328|NCT02808130|B1|Baseline|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
329|NCT02808130|P6|Participant Flow|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
330|NCT02808130|P5|Participant Flow|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
331|NCT02808130|P4|Participant Flow|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
332|NCT02808130|P3|Participant Flow|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
333|NCT02808130|P2|Participant Flow|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
334|NCT02808130|P1|Participant Flow|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
335|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
651|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
652|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
336|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
337|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
338|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
339|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
340|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
341|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
342|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
343|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
344|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
72793|NCT01736475|O1|Outcome|Prophylaxis|
345|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
346|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
347|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
348|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
349|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
350|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
351|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
352|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
353|NCT02808130|E6|Reported Event|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
653|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
354|NCT02808130|E5|Reported Event|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
355|NCT02808130|E4|Reported Event|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
356|NCT02808130|E3|Reported Event|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
357|NCT02808130|E2|Reported Event|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
358|NCT02808130|E1|Reported Event|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
359|NCT02806544|B1|Baseline|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
360|NCT02806544|P1|Participant Flow|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
361|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
362|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
363|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
364|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
365|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
366|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
367|NCT02806544|E1|Reported Event|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
368|NCT02806505|B3|Baseline|Total|Total of all reporting groups
369|NCT02806505|B2|Baseline|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
370|NCT02806505|B1|Baseline|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
371|NCT02806505|P2|Participant Flow|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
372|NCT02806505|P1|Participant Flow|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
373|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
374|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
375|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
376|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
377|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
378|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
379|NCT02806505|E2|Reported Event|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
380|NCT02806505|E1|Reported Event|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
381|NCT02796092|B3|Baseline|Total|Total of all reporting groups
382|NCT02796092|B2|Baseline|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
383|NCT02796092|B1|Baseline|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
384|NCT02796092|P2|Participant Flow|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
385|NCT02796092|P1|Participant Flow|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
386|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
387|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
388|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
389|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
390|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
391|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
392|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
393|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
394|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
395|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
396|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
397|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
398|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
399|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
400|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
401|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
402|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
403|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
404|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
405|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
406|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
407|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
408|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
409|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
410|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
411|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
412|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
413|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
414|NCT02796092|E2|Reported Event|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
415|NCT02796092|E1|Reported Event|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
417|NCT02792049|B2|Baseline|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
418|NCT02792049|B1|Baseline|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
419|NCT02792049|P2|Participant Flow|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
420|NCT02792049|P1|Participant Flow|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
421|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
422|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
423|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
424|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
425|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
426|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
427|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
428|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
429|NCT02792049|O2|Outcome|Conventional Ambu Spur II Bag Valve Mask|A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
430|NCT02792049|O1|Outcome|Modified Ambu Spur II Bag Valve Mask|A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
431|NCT02792049|E2|Reported Event|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
432|NCT02792049|E1|Reported Event|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
433|NCT02791269|B3|Baseline|Total|Total of all reporting groups
434|NCT02791269|B2|Baseline|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
435|NCT02791269|B1|Baseline|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
436|NCT02791269|P2|Participant Flow|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
437|NCT02791269|P1|Participant Flow|HBeAg Negative Participants|Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
438|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
439|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
440|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
441|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
442|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
443|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
444|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
445|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
446|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
447|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
448|NCT02791269|E2|Reported Event|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
449|NCT02791269|E1|Reported Event|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
450|NCT02788097|B3|Baseline|Total|Total of all reporting groups
451|NCT02788097|B2|Baseline|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
452|NCT02788097|B1|Baseline|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
453|NCT02788097|P2|Participant Flow|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
454|NCT02788097|P1|Participant Flow|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
455|NCT02788097|O2|Outcome|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
456|NCT02788097|O1|Outcome|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
457|NCT02788097|E2|Reported Event|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
458|NCT02788097|E1|Reported Event|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
459|NCT02780622|B1|Baseline|All Participants|Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
460|NCT02780622|P2|Participant Flow|First Warfarin and Oseltamivir Then Warfarin|Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
461|NCT02780622|P1|Participant Flow|First Warfarin Then Warfarin and Oseltamivir|Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
462|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
463|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
464|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
465|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
466|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
467|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
468|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
469|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
470|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
471|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
472|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
473|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
474|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
475|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
476|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
477|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
478|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
479|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
480|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
481|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
482|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
483|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
484|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
485|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
486|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
487|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
488|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
489|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
490|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
491|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
492|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
493|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
494|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
495|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
496|NCT02780622|E2|Reported Event|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
497|NCT02780622|E1|Reported Event|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
498|NCT02774278|B1|Baseline|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
499|NCT02774278|P1|Participant Flow|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
500|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
501|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
502|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
503|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
504|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
505|NCT02774278|E1|Reported Event|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
507|NCT02773758|B2|Baseline|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
508|NCT02773758|B1|Baseline|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
509|NCT02773758|P2|Participant Flow|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
510|NCT02773758|P1|Participant Flow|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
511|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
512|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
513|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
514|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
515|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
516|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
517|NCT02773758|E2|Reported Event|Sodium Monofluorophosphate Dentifrice|Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
518|NCT02773758|E1|Reported Event|Stannous Fluoride Dentifrice|Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
519|NCT02772666|B1|Baseline|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
520|NCT02772666|P1|Participant Flow|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
521|NCT02772666|O2|Outcome|Swinging Flashlight Test|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
522|NCT02772666|O1|Outcome|O-Glass|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
523|NCT02772666|E1|Reported Event|All Study Participants|This diagnostic intervention is just an inspection and taking picture of the eye.
524|NCT02766400|B3|Baseline|Total|Total of all reporting groups
525|NCT02766400|B2|Baseline|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
526|NCT02766400|B1|Baseline|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
527|NCT02766400|P2|Participant Flow|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
654|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
528|NCT02766400|P1|Participant Flow|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
529|NCT02766400|O2|Outcome|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
530|NCT02766400|O1|Outcome|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
531|NCT02766400|E2|Reported Event|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
532|NCT02766400|E1|Reported Event|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
533|NCT02766244|B1|Baseline|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
534|NCT02766244|P1|Participant Flow|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
535|NCT02766244|O6|Outcome|Patient 3 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
536|NCT02766244|O5|Outcome|Patient 3 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
537|NCT02766244|O4|Outcome|Patient 2 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
538|NCT02766244|O3|Outcome|Patient 2 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
539|NCT02766244|O2|Outcome|Patient 1 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
540|NCT02766244|O1|Outcome|Patient 1 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
541|NCT02766244|E1|Reported Event|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
542|NCT02765269|B3|Baseline|Total|Total of all reporting groups
543|NCT02765269|B2|Baseline|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
544|NCT02765269|B1|Baseline|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
545|NCT02765269|P2|Participant Flow|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
546|NCT02765269|P1|Participant Flow|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
655|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
547|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
548|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
549|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
550|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
551|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
552|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
553|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
554|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
555|NCT02765269|E2|Reported Event|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
556|NCT02765269|E1|Reported Event|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
557|NCT02761629|B3|Baseline|Total|Total of all reporting groups
558|NCT02761629|B2|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
559|NCT02761629|B1|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
560|NCT02761629|P2|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
561|NCT02761629|P1|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
562|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
563|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
564|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
656|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
657|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
565|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
566|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
567|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
568|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
569|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
570|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
571|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
572|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
573|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
574|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
575|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
576|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
577|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
578|NCT02761629|E2|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
579|NCT02761629|E1|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
580|NCT02756351|B3|Baseline|Total|Total of all reporting groups
658|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
581|NCT02756351|B2|Baseline|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
582|NCT02756351|B1|Baseline|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
583|NCT02756351|P2|Participant Flow|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
584|NCT02756351|P1|Participant Flow|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
585|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
586|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
587|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
588|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
589|NCT02756351|E2|Reported Event|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
590|NCT02756351|E1|Reported Event|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
591|NCT02755805|B3|Baseline|Total|Total of all reporting groups
592|NCT02755805|B2|Baseline|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
593|NCT02755805|B1|Baseline|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
594|NCT02755805|P2|Participant Flow|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
595|NCT02755805|P1|Participant Flow|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
596|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
597|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
598|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
599|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
600|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
601|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
602|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
659|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
660|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
661|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
603|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
604|NCT02755805|E2|Reported Event|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
605|NCT02755805|E1|Reported Event|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
606|NCT02753699|B4|Baseline|Total|Total of all reporting groups
607|NCT02753699|B3|Baseline|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
608|NCT02753699|B2|Baseline|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
609|NCT02753699|B1|Baseline|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
610|NCT02753699|P3|Participant Flow|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
611|NCT02753699|P2|Participant Flow|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
612|NCT02753699|P1|Participant Flow|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
613|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
614|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
615|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
616|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
617|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
618|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
619|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
620|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
621|NCT02753699|E4|Reported Event|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
622|NCT02753699|E3|Reported Event|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
623|NCT02753699|E2|Reported Event|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
624|NCT02753699|E1|Reported Event|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
625|NCT02750943|B3|Baseline|Total|Total of all reporting groups
626|NCT02750943|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
627|NCT02750943|B1|Baseline|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
628|NCT02750943|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
629|NCT02750943|P1|Participant Flow|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
630|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
631|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
632|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
633|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
662|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
634|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
635|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
636|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
637|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
638|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
639|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
640|NCT02750943|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
641|NCT02750943|E1|Reported Event|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
642|NCT02750709|B1|Baseline|All Study Participants|
643|NCT02750709|P6|Participant Flow|Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
644|NCT02750709|P5|Participant Flow|Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
645|NCT02750709|P4|Participant Flow|Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
646|NCT02750709|P3|Participant Flow|Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
647|NCT02750709|P2|Participant Flow|Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
648|NCT02750709|P1|Participant Flow|Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
649|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
650|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
663|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
664|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
665|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
666|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
667|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
668|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
669|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
670|NCT02750709|E3|Reported Event|Reference Product|ORFADIN® hard capsule, 10 mg
671|NCT02750709|E2|Reported Event|Test Product 2|Nitisinone Tablet (High Compritol), 10 mg
672|NCT02750709|E1|Reported Event|Test Product 1|Nitisinone Tablet, 10 mg
673|NCT02750345|B1|Baseline|All Study Participants|Grouped by all participants as this is how overall data has been collected.
674|NCT02750345|P6|Participant Flow|Sequence Reference - TP 2 - TP 1|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
675|NCT02750345|P5|Participant Flow|Sequence Reference - TP 1 - TP 2|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
676|NCT02750345|P4|Participant Flow|Sequence TP 2 - Reference - TP 1|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
677|NCT02750345|P3|Participant Flow|Sequence TP 2 - TP 1 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
678|NCT02750345|P2|Participant Flow|Sequence TP 1 - Reference - TP 2|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
679|NCT02750345|P1|Participant Flow|Sequence TP 1 - TP 2 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1 (TP 1)) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2 (TP 2)) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
680|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
681|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
682|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
683|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
684|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
685|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
686|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
687|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
688|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
689|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
690|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
691|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
692|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
693|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
694|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
695|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
696|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
697|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
698|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
699|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
700|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
701|NCT02750345|E3|Reported Event|Reference Product|ORFADIN®, 10 mg hard capsule
702|NCT02750345|E2|Reported Event|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
703|NCT02750345|E1|Reported Event|Test Product 1|10 mg Nitisinone Tablet
704|NCT02750332|B1|Baseline|All Study Participants|
705|NCT02750332|P2|Participant Flow|Treatment Sequence B (Fasted) - A (Fed)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
706|NCT02750332|P1|Participant Flow|Treatment Sequence A (Fed) - B (Fasted)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
707|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
708|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
709|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
710|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
711|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
712|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
713|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
714|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
715|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
716|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
717|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
718|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
719|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
720|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
721|NCT02750332|E2|Reported Event|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
722|NCT02750332|E1|Reported Event|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
723|NCT02748213|B3|Baseline|Total|Total of all reporting groups
724|NCT02748213|B2|Baseline|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
725|NCT02748213|B1|Baseline|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
726|NCT02748213|P2|Participant Flow|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
727|NCT02748213|P1|Participant Flow|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
728|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
729|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
806|NCT02743702|B2|Baseline|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
730|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
731|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
732|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
733|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
734|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
735|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
736|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
737|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
738|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
739|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
740|NCT02748213|E2|Reported Event|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
741|NCT02748213|E1|Reported Event|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
742|NCT02746679|B3|Baseline|Total|Total of all reporting groups
743|NCT02746679|B2|Baseline|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
803|NCT02743936|E2|Reported Event|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
1316|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
744|NCT02746679|B1|Baseline|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
745|NCT02746679|P2|Participant Flow|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
746|NCT02746679|P1|Participant Flow|MBSR Group|"The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.~Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this"
747|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
748|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
749|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
750|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
751|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
752|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
753|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
754|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
755|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
756|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
757|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
883|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
758|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
759|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
760|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
761|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
762|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
763|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
764|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
765|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
766|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
767|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
768|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
769|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
770|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
771|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
804|NCT02743936|E1|Reported Event|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
805|NCT02743702|B3|Baseline|Total|Total of all reporting groups
772|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
773|NCT02746679|E2|Reported Event|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
774|NCT02746679|E1|Reported Event|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
775|NCT02746406|B1|Baseline|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
776|NCT02746406|P1|Participant Flow|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
777|NCT02746406|O1|Outcome|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
778|NCT02746406|E1|Reported Event|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
779|NCT02746107|B1|Baseline|All Participants|all participants in the study (968)
780|NCT02746107|P1|Participant Flow|All Study Participants|all study participants were 968 (in all arms of this factorial RCT)
781|NCT02746107|O5|Outcome|CHA2D2S-VASC Risk Score 5|
782|NCT02746107|O4|Outcome|CHA2D2S-VASC Risk Score 4|
783|NCT02746107|O3|Outcome|CHA2D2S-VASC Risk Score 3|
784|NCT02746107|O2|Outcome|CHA2D2S-VASC Risk Score 2|
785|NCT02746107|O1|Outcome|CHA2D2S-VASC Risk Score 1|
786|NCT02746107|O2|Outcome|Prescription to Physician Himself|the participants had to imagine that they had atrial fibrillation, the risk from the diagram was theirs, and had to decide to take or not the OACs
787|NCT02746107|O1|Outcome|Prescription to Patient|the participant physician were randomized to prescribe OAC to virtual patients
788|NCT02746107|O2|Outcome|1 Year Risk Estimation on DA (CHA2D2S-VASC Score)|participants deciding to prescribe or not OAC after seeing the stroke risk estimation on 1 year (classical CHA2D2S-VASC score)
789|NCT02746107|O1|Outcome|5 Years Risk Estimation on DA|participants had to prescribe or not OAC after seeing the risk estimated on 5 years
790|NCT02746107|O2|Outcome|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams"
791|NCT02746107|O1|Outcome|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams"
792|NCT02746107|E2|Reported Event|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 406 of 482 (83.5%)"
793|NCT02746107|E1|Reported Event|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 400 of 486 (83%)"
794|NCT02743936|B3|Baseline|Total|Total of all reporting groups
795|NCT02743936|B2|Baseline|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
796|NCT02743936|B1|Baseline|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
797|NCT02743936|P2|Participant Flow|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
798|NCT02743936|P1|Participant Flow|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
799|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
800|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
801|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
802|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
1317|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
807|NCT02743702|B1|Baseline|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
808|NCT02743702|P2|Participant Flow|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
809|NCT02743702|P1|Participant Flow|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
810|NCT02743702|O2|Outcome|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
811|NCT02743702|O1|Outcome|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
812|NCT02743702|E2|Reported Event|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
813|NCT02743702|E1|Reported Event|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
814|NCT02739594|B3|Baseline|Total|Total of all reporting groups
815|NCT02739594|B2|Baseline|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
816|NCT02739594|B1|Baseline|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
817|NCT02739594|P2|Participant Flow|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
818|NCT02739594|P1|Participant Flow|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
819|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
820|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
1059|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
821|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
822|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
823|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
824|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
825|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
826|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
827|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
828|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
829|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
830|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
831|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
832|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
833|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
834|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
835|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
836|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
837|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
838|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
1318|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
839|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
840|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
841|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
842|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
843|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
844|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
845|NCT02739594|E2|Reported Event|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
846|NCT02739594|E1|Reported Event|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
847|NCT02736721|B1|Baseline|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
848|NCT02736721|P1|Participant Flow|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
849|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
850|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
851|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
852|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
853|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
854|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
855|NCT02736721|E1|Reported Event|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
856|NCT02732639|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
884|NCT02732210|E2|Reported Event|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
857|NCT02732639|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
858|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
859|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
860|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
861|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
862|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
863|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
864|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
865|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
866|NCT02732639|E1|Reported Event|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
867|NCT02732210|B3|Baseline|Total|Total of all reporting groups
868|NCT02732210|B2|Baseline|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
869|NCT02732210|B1|Baseline|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
870|NCT02732210|P2|Participant Flow|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
871|NCT02732210|P1|Participant Flow|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
872|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
873|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
874|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
875|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
876|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
877|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
878|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
879|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
880|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
881|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
882|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
1060|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
885|NCT02732210|E1|Reported Event|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
886|NCT02731313|B1|Baseline|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma Samples|"Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned~Trastuzumab: Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions."
887|NCT02731313|P1|Participant Flow|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
888|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
889|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
890|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
891|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
892|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
893|NCT02731313|E1|Reported Event|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
894|NCT02731300|B3|Baseline|Total|Total of all reporting groups
895|NCT02731300|B2|Baseline|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
896|NCT02731300|B1|Baseline|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
897|NCT02731300|P2|Participant Flow|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
898|NCT02731300|P1|Participant Flow|Active tDCS|"2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
899|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
900|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
901|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
902|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
903|NCT02731300|E2|Reported Event|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
904|NCT02731300|E1|Reported Event|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
905|NCT02731131|B3|Baseline|Total|Total of all reporting groups
906|NCT02731131|B2|Baseline|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
907|NCT02731131|B1|Baseline|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
908|NCT02731131|P2|Participant Flow|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
909|NCT02731131|P1|Participant Flow|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
910|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
911|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
912|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
913|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
914|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
915|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
1061|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
916|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
917|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
918|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
919|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
920|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
921|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
922|NCT02731131|E2|Reported Event|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
923|NCT02731131|E1|Reported Event|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
924|NCT02730260|B3|Baseline|Total|Total of all reporting groups
925|NCT02730260|B2|Baseline|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
926|NCT02730260|B1|Baseline|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
927|NCT02730260|P2|Participant Flow|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
928|NCT02730260|P1|Participant Flow|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
929|NCT02730260|O2|Outcome|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
930|NCT02730260|O1|Outcome|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
931|NCT02730260|E2|Reported Event|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
932|NCT02730260|E1|Reported Event|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
933|NCT02726022|B1|Baseline|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
934|NCT02726022|P1|Participant Flow|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
935|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
936|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
937|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
938|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
1044|NCT02709577|O1|Outcome|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
939|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
940|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
941|NCT02726022|E1|Reported Event|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
942|NCT02717754|B7|Baseline|Total|Total of all reporting groups
943|NCT02717754|B6|Baseline|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
944|NCT02717754|B5|Baseline|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
945|NCT02717754|B4|Baseline|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
946|NCT02717754|B3|Baseline|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
947|NCT02717754|B2|Baseline|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
948|NCT02717754|B1|Baseline|Placebo|Participants received oseltamivir matched placebo BID for 5 days.
949|NCT02717754|P6|Participant Flow|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
950|NCT02717754|P5|Participant Flow|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
951|NCT02717754|P4|Participant Flow|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
952|NCT02717754|P3|Participant Flow|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
953|NCT02717754|P2|Participant Flow|Oseltamivir 100 mg|Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.
954|NCT02717754|P1|Participant Flow|Placebo|Participants received oseltamivir matched placebo twice daily (BID) for 5 days.
955|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
956|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
957|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
958|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
959|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
960|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
961|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
962|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
963|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
964|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
965|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
966|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
967|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
968|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
969|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
970|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
971|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
972|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
973|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
974|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
975|NCT02717754|E6|Reported Event|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
976|NCT02717754|E5|Reported Event|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
977|NCT02717754|E4|Reported Event|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
978|NCT02717754|E3|Reported Event|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
979|NCT02717754|E2|Reported Event|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
980|NCT02717754|E1|Reported Event|Placebo|Participants received oseltamivir matched placebo for 5 days.
981|NCT02716779|B4|Baseline|Total|Total of all reporting groups
1062|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
982|NCT02716779|B3|Baseline|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
983|NCT02716779|B2|Baseline|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
984|NCT02716779|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
985|NCT02716779|P3|Participant Flow|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
986|NCT02716779|P2|Participant Flow|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
987|NCT02716779|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
988|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
989|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1045|NCT02709577|E2|Reported Event|Cohorts A and B Sham: Endoscopy and Standard of Care|Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
1046|NCT02709577|E1|Reported Event|Cohorts A and B: EndoBarrier Gastrointestinal Liner|Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
990|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
991|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
992|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
993|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
994|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
995|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
996|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
997|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1047|NCT02708524|B5|Baseline|Total|Total of all reporting groups
1048|NCT02708524|B4|Baseline|Samfilcon A|All subjects that wore the samfilcon A lens throughout the duration of the study.
1049|NCT02708524|B3|Baseline|Lotrafilcon B|All subjects that wore the lotrafilcon B lens throughout the duration of the study.
1050|NCT02708524|B2|Baseline|Comfilcon A|All subjects that wore the comfilcon A lens throughout the duration of the study.
998|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
999|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1000|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1001|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1002|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1003|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1004|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1005|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1051|NCT02708524|B1|Baseline|Senofilcon C|All subjects that wore the senofilcon C lens throughout the duration of the study.
1052|NCT02708524|P4|Participant Flow|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1053|NCT02708524|P3|Participant Flow|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1006|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1007|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1008|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1009|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1010|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1011|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1012|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1013|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1054|NCT02708524|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1055|NCT02708524|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1056|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
9047|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
1014|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1015|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1016|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1017|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1018|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1019|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1020|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1021|NCT02716779|O3|Outcome|Total Participant Group|Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
1022|NCT02716779|O2|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1057|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1058|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1319|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1023|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
1024|NCT02716779|E6|Reported Event|Ribavirin, Period 2 Combination Therapy|"In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
1025|NCT02716779|E5|Reported Event|Placebo, Period 2 Combination Therapy|"In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
1026|NCT02716779|E4|Reported Event|PEG-IFN Alfa-2a, Period 2 Combination Therapy|"In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
1027|NCT02716779|E3|Reported Event|Ribavirin, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
1028|NCT02716779|E2|Reported Event|Placebo, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks."
1029|NCT02716779|E1|Reported Event|PEG-IFN Alfa-2a, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks."
1030|NCT02709577|B3|Baseline|Total|Total of all reporting groups
1031|NCT02709577|B2|Baseline|Sham: Endoscopy and Standard of Care|"Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.~Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes"
1032|NCT02709577|B1|Baseline|EndoBarrier Gastrointestinal Liner|"Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.~EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum."
1033|NCT02709577|P4|Participant Flow|Cohort B Control Sham|Device not implanted.
1034|NCT02709577|P3|Participant Flow|Cohort A Control Sham|Device was not implanted
1035|NCT02709577|P2|Participant Flow|Cohort B:EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
1036|NCT02709577|P1|Participant Flow|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
1037|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was 12 months.
1038|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was originally 6 months and then extended to 12 months based on physician discretion.
1039|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
1040|NCT02709577|O1|Outcome|Cohoart A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
1041|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
1042|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
1043|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
1184|NCT02701270|E3|Reported Event|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
1063|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1064|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1065|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1066|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1067|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1068|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1069|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1070|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1071|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1072|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1073|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1074|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1075|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1076|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1077|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1078|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1079|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1080|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1081|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1082|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1083|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1084|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1085|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1086|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1087|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1088|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1089|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1090|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1091|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1092|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1093|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1094|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1095|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1096|NCT02708524|E4|Reported Event|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
1097|NCT02708524|E3|Reported Event|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
1098|NCT02708524|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
1099|NCT02708524|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
1100|NCT02708277|B3|Baseline|Total|Total of all reporting groups
1101|NCT02708277|B2|Baseline|Group B|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1102|NCT02708277|B1|Baseline|Group A|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1103|NCT02708277|P2|Participant Flow|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1185|NCT02701270|E2|Reported Event|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
9048|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
1104|NCT02708277|P1|Participant Flow|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1105|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1106|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1107|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1108|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1109|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1110|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1111|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1112|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1113|NCT02708277|E2|Reported Event|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
1114|NCT02708277|E1|Reported Event|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
1115|NCT02708238|B4|Baseline|Total|Total of all reporting groups
1116|NCT02708238|B3|Baseline|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
1117|NCT02708238|B2|Baseline|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
1118|NCT02708238|B1|Baseline|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
1119|NCT02708238|P3|Participant Flow|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
1120|NCT02708238|P2|Participant Flow|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
1121|NCT02708238|P1|Participant Flow|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
1122|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
1123|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
1186|NCT02701270|E1|Reported Event|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
1320|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1124|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
1125|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
1126|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
1127|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
1128|NCT02708238|E3|Reported Event|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
1129|NCT02708238|E2|Reported Event|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
1130|NCT02708238|E1|Reported Event|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
1131|NCT02708212|B3|Baseline|Total|Total of all reporting groups
1132|NCT02708212|B2|Baseline|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
1133|NCT02708212|B1|Baseline|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
1134|NCT02708212|P2|Participant Flow|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
1135|NCT02708212|P1|Participant Flow|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
1136|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|The duration of both colonoscopy and EGD examinations was recorded and compared.
1137|NCT02708212|O1|Outcome|EGD-colonoscopy Group|The duration of both EGD and colonoscopy examinations was recorded and compared.
1138|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
1139|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
1140|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
1321|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1141|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
1142|NCT02708212|E2|Reported Event|Colonoscopy-EGD Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
1143|NCT02708212|E1|Reported Event|EGD-colonoscopy Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
1144|NCT02707640|B3|Baseline|Total|Total of all reporting groups
1145|NCT02707640|B2|Baseline|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1146|NCT02707640|B1|Baseline|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1147|NCT02707640|P2|Participant Flow|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1148|NCT02707640|P1|Participant Flow|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1149|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1150|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1151|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1152|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1153|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1154|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1155|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1156|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1157|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1187|NCT02699892|B1|Baseline|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
1158|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1159|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1160|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1161|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1162|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1163|NCT02707640|E2|Reported Event|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1164|NCT02707640|E1|Reported Event|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
1165|NCT02701387|B1|Baseline|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
1166|NCT02701387|P1|Participant Flow|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
1167|NCT02701387|O2|Outcome|EZ Plus Implant|"Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market."
1168|NCT02701387|O1|Outcome|AnyRidge Implant|"Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth)."
1169|NCT02701387|E1|Reported Event|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
1170|NCT02701270|B1|Baseline|All Study Participants|All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
1171|NCT02701270|P4|Participant Flow|Fibre 2 First, Then Polydextrose, Dextrose and Fibre1|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
1172|NCT02701270|P3|Participant Flow|Fibre1 First, Then Fibre 2, Polydextrose and Dextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control.
1173|NCT02701270|P2|Participant Flow|Dextrose First, Then Fibre1, Fibre 2 and Polydextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control.
1174|NCT02701270|P1|Participant Flow|Polydextrose First, Then Dextrose, Fibre1 and Fibre 2|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2.
1175|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
1176|NCT02701270|O3|Outcome|Polydextrose|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
1177|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
1178|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
1179|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
1180|NCT02701270|O3|Outcome|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
1181|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
1182|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
1183|NCT02701270|E4|Reported Event|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
9049|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
1188|NCT02699892|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
1189|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
1190|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
1191|NCT02699892|E1|Reported Event|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
1192|NCT02694718|B1|Baseline|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1193|NCT02694718|P1|Participant Flow|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1194|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1195|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1196|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1197|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1198|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1199|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1200|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1201|NCT02694718|E1|Reported Event|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
1202|NCT02694536|B1|Baseline|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1265|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1203|NCT02694536|P1|Participant Flow|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1204|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1205|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1206|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1207|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1208|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1209|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1210|NCT02694536|E1|Reported Event|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
1211|NCT02694315|B1|Baseline|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
1212|NCT02694315|P1|Participant Flow|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
1213|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
1214|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
1215|NCT02694315|E1|Reported Event|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
1216|NCT02694198|B1|Baseline|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
1217|NCT02694198|P1|Participant Flow|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
9050|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
1218|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
1219|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
1220|NCT02694198|E1|Reported Event|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
1221|NCT02693704|B5|Baseline|Total|Total of all reporting groups
1222|NCT02693704|B4|Baseline|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1223|NCT02693704|B3|Baseline|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1224|NCT02693704|B2|Baseline|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1225|NCT02693704|B1|Baseline|Normal Hearing|People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
1226|NCT02693704|P4|Participant Flow|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1227|NCT02693704|P3|Participant Flow|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1228|NCT02693704|P2|Participant Flow|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1229|NCT02693704|P1|Participant Flow|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
1230|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1266|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
9051|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
1231|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1232|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1233|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
1234|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1235|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1236|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1237|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
1238|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1239|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1240|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1267|NCT02691416|E2|Reported Event|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
9052|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
1241|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
1242|NCT02693704|E4|Reported Event|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1243|NCT02693704|E3|Reported Event|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1244|NCT02693704|E2|Reported Event|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
1245|NCT02693704|E1|Reported Event|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
1246|NCT02691416|B3|Baseline|Total|Total of all reporting groups
1247|NCT02691416|B2|Baseline|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1248|NCT02691416|B1|Baseline|Propofol Postconditioning|1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
1249|NCT02691416|P2|Participant Flow|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1250|NCT02691416|P1|Participant Flow|Propofol Postconditioning|Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
1251|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1252|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
1253|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1254|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal"
1255|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1256|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
1257|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1258|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
1259|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1260|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
1261|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1262|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
1263|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
1264|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
1268|NCT02691416|E1|Reported Event|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
1269|NCT02687217|B3|Baseline|Total|Total of all reporting groups
1270|NCT02687217|B2|Baseline|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1271|NCT02687217|B1|Baseline|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1272|NCT02687217|P2|Participant Flow|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1273|NCT02687217|P1|Participant Flow|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1274|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1275|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1276|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1277|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1278|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1279|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1280|NCT02687217|E2|Reported Event|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
1281|NCT02687217|E1|Reported Event|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
1282|NCT02684604|B3|Baseline|Total|Total of all reporting groups
1283|NCT02684604|B2|Baseline|Fertile Women|44 fertile women
1284|NCT02684604|B1|Baseline|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
1285|NCT02684604|P2|Participant Flow|Fertile Women|44 fertile women
1286|NCT02684604|P1|Participant Flow|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
1287|NCT02684604|O2|Outcome|Fertile Women|44 fertile women
1288|NCT02684604|O1|Outcome|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
1289|NCT02684604|E2|Reported Event|Fertile Women|44 fertile women
1290|NCT02684604|E1|Reported Event|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
1291|NCT02684396|B7|Baseline|Total|Total of all reporting groups
1292|NCT02684396|B6|Baseline|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1293|NCT02684396|B5|Baseline|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1294|NCT02684396|B4|Baseline|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1295|NCT02684396|B3|Baseline|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1296|NCT02684396|B2|Baseline|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1297|NCT02684396|B1|Baseline|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1298|NCT02684396|P6|Participant Flow|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1299|NCT02684396|P5|Participant Flow|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1300|NCT02684396|P4|Participant Flow|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1301|NCT02684396|P3|Participant Flow|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1302|NCT02684396|P2|Participant Flow|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1303|NCT02684396|P1|Participant Flow|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1304|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1305|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1306|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1307|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1308|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1309|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1310|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1311|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1312|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1313|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1314|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1315|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1322|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1323|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1324|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1325|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1326|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1327|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1328|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1329|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1330|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1331|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1332|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1333|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1334|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1335|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1336|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1337|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1338|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1339|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1340|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1341|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1342|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1343|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1344|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1345|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1346|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1347|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1348|NCT02684396|E6|Reported Event|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
1349|NCT02684396|E5|Reported Event|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
1350|NCT02684396|E4|Reported Event|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
1351|NCT02684396|E3|Reported Event|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
1352|NCT02684396|E2|Reported Event|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
1353|NCT02684396|E1|Reported Event|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
1354|NCT02683954|B3|Baseline|Total|Total of all reporting groups
1355|NCT02683954|B2|Baseline|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1356|NCT02683954|B1|Baseline|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1357|NCT02683954|P2|Participant Flow|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1358|NCT02683954|P1|Participant Flow|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1359|NCT02683954|O2|Outcome|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1360|NCT02683954|O1|Outcome|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1361|NCT02683954|E2|Reported Event|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1362|NCT02683954|E1|Reported Event|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
1363|NCT02681458|B3|Baseline|Total|Total of all reporting groups
1364|NCT02681458|B2|Baseline|Non-drug Users|"Control group that consisted of non drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1365|NCT02681458|B1|Baseline|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1366|NCT02681458|P2|Participant Flow|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1367|NCT02681458|P1|Participant Flow|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1368|NCT02681458|O2|Outcome|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1369|NCT02681458|O1|Outcome|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1370|NCT02681458|E2|Reported Event|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1371|NCT02681458|E1|Reported Event|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
1372|NCT02679976|B1|Baseline|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1373|NCT02679976|P1|Participant Flow|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1374|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1375|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1376|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1377|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1378|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1379|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1380|NCT02679976|E1|Reported Event|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
1381|NCT02678676|B3|Baseline|Total|Total of all reporting groups
1382|NCT02678676|B2|Baseline|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
1383|NCT02678676|B1|Baseline|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
1384|NCT02678676|P2|Participant Flow|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
1385|NCT02678676|P1|Participant Flow|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
1386|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
1387|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
1388|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
1389|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
1390|NCT02678676|E2|Reported Event|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
1391|NCT02678676|E1|Reported Event|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
1392|NCT02677779|B3|Baseline|Total|Total of all reporting groups
1393|NCT02677779|B2|Baseline|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1394|NCT02677779|B1|Baseline|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1395|NCT02677779|P2|Participant Flow|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1396|NCT02677779|P1|Participant Flow|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1397|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1398|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1399|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1400|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1401|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1402|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1479|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1403|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1404|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1405|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1406|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1407|NCT02677779|E2|Reported Event|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
1408|NCT02677779|E1|Reported Event|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
1409|NCT02677493|B4|Baseline|Total|Total of all reporting groups
1410|NCT02677493|B3|Baseline|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1411|NCT02677493|B2|Baseline|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
1412|NCT02677493|B1|Baseline|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1413|NCT02677493|P3|Participant Flow|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1414|NCT02677493|P2|Participant Flow|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
1415|NCT02677493|P1|Participant Flow|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1416|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1417|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
1418|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1419|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1420|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
1421|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1422|NCT02677493|E3|Reported Event|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1423|NCT02677493|E2|Reported Event|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
1424|NCT02677493|E1|Reported Event|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
1425|NCT02673944|B1|Baseline|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
1426|NCT02673944|P1|Participant Flow|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
1427|NCT02673944|O2|Outcome|Standard Urodynamic Analyzer|Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
1428|NCT02673944|O1|Outcome|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
1429|NCT02673944|E1|Reported Event|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
1430|NCT02670811|B3|Baseline|Total|Total of all reporting groups
1431|NCT02670811|B2|Baseline|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1432|NCT02670811|B1|Baseline|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1433|NCT02670811|P2|Participant Flow|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1434|NCT02670811|P1|Participant Flow|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1435|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1480|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1436|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1437|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1438|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1439|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1440|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1441|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1442|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1443|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1444|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1445|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1446|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1447|NCT02670811|E2|Reported Event|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
1448|NCT02670811|E1|Reported Event|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
1449|NCT02666560|B1|Baseline|All Study Participants|"Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.~Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.~This was a crossover design where participants completed both arms in the trial."
1450|NCT02666560|P2|Participant Flow|Cueing at 20% Above Self Paced Cadence Then Self Based Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."
1451|NCT02666560|P1|Participant Flow|Cueing Self Paced Then Cueing 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.~Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."
1452|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
1453|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1454|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
1455|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1456|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
1457|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1458|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
1459|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1460|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
1461|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1462|NCT02666560|O2|Outcome|AC20|Auditory cueing set at 20% above self paced cadence
1463|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
1464|NCT02666560|E2|Reported Event|Cueing at 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.~Auditory Cueing: Auditory cueing set at different frequency rates"
1465|NCT02666560|E1|Reported Event|Auditory Cueing at Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: Auditory cueing set at different frequency rates"
1466|NCT02666222|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1467|NCT02666222|P1|Participant Flow|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1468|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1469|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1470|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1471|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1472|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1473|NCT02666222|E1|Reported Event|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
1474|NCT02664987|B1|Baseline|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1475|NCT02664987|P1|Participant Flow|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1476|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1477|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1478|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
3345|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
1481|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1482|NCT02664987|E1|Reported Event|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
1483|NCT02664532|B3|Baseline|Total|Total of all reporting groups
1484|NCT02664532|B2|Baseline|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1485|NCT02664532|B1|Baseline|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1486|NCT02664532|P2|Participant Flow|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1487|NCT02664532|P1|Participant Flow|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1488|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1489|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1490|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1491|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1492|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1493|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1494|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1495|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1496|NCT02664532|E2|Reported Event|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
1497|NCT02664532|E1|Reported Event|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
1498|NCT02663232|B1|Baseline|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1499|NCT02663232|P1|Participant Flow|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
2066|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
1500|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1501|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1502|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1503|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1504|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1505|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1506|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1507|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1508|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1509|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1510|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1511|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1512|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1513|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1514|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1515|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1516|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1517|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1518|NCT02663232|E1|Reported Event|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
1519|NCT02658461|B4|Baseline|Total|Total of all reporting groups
1520|NCT02658461|B3|Baseline|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1521|NCT02658461|B2|Baseline|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1522|NCT02658461|B1|Baseline|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1523|NCT02658461|P3|Participant Flow|Trastuzumab Intravenous (IV) Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
2067|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
1524|NCT02658461|P2|Participant Flow|Trastuzumab Subcutaneous (SC) Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1525|NCT02658461|P1|Participant Flow|Trastuzumab Single-Use Injection Device|Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1526|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1527|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1528|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1529|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1530|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1531|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1532|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1533|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1534|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1535|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1536|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1537|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1538|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1539|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1540|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1541|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1542|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1543|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1544|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1545|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1546|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1547|NCT02658461|E3|Reported Event|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1548|NCT02658461|E2|Reported Event|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1549|NCT02658461|E1|Reported Event|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
1550|NCT02657629|B3|Baseline|Total|Total of all reporting groups
1551|NCT02657629|B2|Baseline|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1552|NCT02657629|B1|Baseline|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1553|NCT02657629|P2|Participant Flow|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1554|NCT02657629|P1|Participant Flow|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1555|NCT02657629|O2|Outcome|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1556|NCT02657629|O1|Outcome|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1557|NCT02657629|E2|Reported Event|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1558|NCT02657629|E1|Reported Event|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
1559|NCT02657538|B1|Baseline|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
1560|NCT02657538|P1|Participant Flow|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
1561|NCT02657538|O1|Outcome|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
1562|NCT02657538|O2|Outcome|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
1585|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
3346|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
1563|NCT02657538|O1|Outcome|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
1564|NCT02657538|E2|Reported Event|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
1565|NCT02657538|E1|Reported Event|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
1566|NCT02653560|B1|Baseline|All Study Participants|Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
1567|NCT02653560|P4|Participant Flow|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
1568|NCT02653560|P3|Participant Flow|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
1569|NCT02653560|P2|Participant Flow|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
1570|NCT02653560|P1|Participant Flow|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
1571|NCT02653560|O4|Outcome|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
1572|NCT02653560|O3|Outcome|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
1573|NCT02653560|O2|Outcome|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
1574|NCT02653560|O1|Outcome|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
1575|NCT02653560|E4|Reported Event|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
1576|NCT02653560|E3|Reported Event|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
1577|NCT02653560|E2|Reported Event|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
1578|NCT02653560|E1|Reported Event|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
1579|NCT02650219|B3|Baseline|Total|Total of all reporting groups
1580|NCT02650219|B2|Baseline|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
1581|NCT02650219|B1|Baseline|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
1582|NCT02650219|P2|Participant Flow|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
1583|NCT02650219|P1|Participant Flow|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
1584|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
1586|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
9053|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
1587|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
1588|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
1589|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
1590|NCT02650219|E2|Reported Event|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
1591|NCT02650219|E1|Reported Event|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
1592|NCT02648022|B3|Baseline|Total|Total of all reporting groups
1593|NCT02648022|B2|Baseline|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1594|NCT02648022|B1|Baseline|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1595|NCT02648022|P2|Participant Flow|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1596|NCT02648022|P1|Participant Flow|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1597|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1598|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1599|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1600|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1601|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1602|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1603|NCT02648022|E2|Reported Event|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
1604|NCT02648022|E1|Reported Event|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
1605|NCT02645760|B3|Baseline|Total|Total of all reporting groups
1606|NCT02645760|B2|Baseline|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1607|NCT02645760|B1|Baseline|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
1608|NCT02645760|P2|Participant Flow|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1609|NCT02645760|P1|Participant Flow|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
1610|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1611|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
1612|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1613|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
1614|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1615|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
1616|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1617|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
1618|NCT02645760|E2|Reported Event|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
1619|NCT02645760|E1|Reported Event|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
1620|NCT02644109|B3|Baseline|Total|Total of all reporting groups
1621|NCT02644109|B2|Baseline|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1622|NCT02644109|B1|Baseline|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1623|NCT02644109|P2|Participant Flow|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
1624|NCT02644109|P1|Participant Flow|Phytosterols|"Milk powder: subjects will consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols).~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
1625|NCT02644109|O2|Outcome|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1626|NCT02644109|O1|Outcome|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1627|NCT02644109|E2|Reported Event|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1628|NCT02644109|E1|Reported Event|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
1629|NCT02644096|B3|Baseline|Total|Total of all reporting groups
1630|NCT02644096|B2|Baseline|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
1631|NCT02644096|B1|Baseline|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
1632|NCT02644096|P2|Participant Flow|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
1633|NCT02644096|P1|Participant Flow|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
1634|NCT02644096|O2|Outcome|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation.after THR."
1635|NCT02644096|O1|Outcome|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
1636|NCT02644096|E2|Reported Event|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR."
1637|NCT02644096|E1|Reported Event|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
1638|NCT02643225|B3|Baseline|Total|Total of all reporting groups
1639|NCT02643225|B2|Baseline|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1640|NCT02643225|B1|Baseline|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1641|NCT02643225|P2|Participant Flow|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
1642|NCT02643225|P1|Participant Flow|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
1643|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1658|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
9054|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
1644|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1645|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1646|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1647|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1648|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1649|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1650|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1651|NCT02643225|E2|Reported Event|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1652|NCT02643225|E1|Reported Event|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
1653|NCT02641912|B3|Baseline|Total|Total of all reporting groups
1654|NCT02641912|B2|Baseline|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1655|NCT02641912|B1|Baseline|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1656|NCT02641912|P2|Participant Flow|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1657|NCT02641912|P1|Participant Flow|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1704|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1659|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1660|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
1661|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1662|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
1663|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1664|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1665|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1666|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1667|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1668|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1669|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1670|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1671|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1672|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1673|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1674|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1675|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1676|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1677|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1678|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
1679|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1680|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1838|NCT02630563|B1|Baseline|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1681|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1682|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1683|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1684|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1685|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1686|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
1687|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
1688|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
1689|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
1690|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
1691|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
1692|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
1693|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
1694|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
1695|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
1696|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1697|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1698|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1699|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1700|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
1701|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1702|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1703|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1886|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1705|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1706|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1707|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1708|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1709|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1710|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1711|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1712|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1713|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1714|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1715|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1716|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1717|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1718|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1719|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1720|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
1721|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
1722|NCT02641912|E2|Reported Event|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
1723|NCT02641912|E1|Reported Event|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
1724|NCT02641379|B12|Baseline|Total|Total of all reporting groups
1725|NCT02641379|B11|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1726|NCT02641379|B10|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
1839|NCT02630563|P1|Participant Flow|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1727|NCT02641379|B9|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1728|NCT02641379|B8|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1729|NCT02641379|B7|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1730|NCT02641379|B6|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1731|NCT02641379|B5|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1732|NCT02641379|B4|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1733|NCT02641379|B3|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1734|NCT02641379|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1735|NCT02641379|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1736|NCT02641379|P11|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1737|NCT02641379|P10|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
1738|NCT02641379|P9|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1739|NCT02641379|P8|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1740|NCT02641379|P7|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1741|NCT02641379|P6|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1742|NCT02641379|P5|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1743|NCT02641379|P4|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1744|NCT02641379|P3|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1745|NCT02641379|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1746|NCT02641379|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1747|NCT02641379|O6|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1748|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
1749|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1840|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
1750|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1751|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1752|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1753|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
1754|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1755|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1756|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1757|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1758|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1759|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1760|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1841|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
1761|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1762|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1763|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1764|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1765|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1766|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1767|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1768|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1769|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1770|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1771|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1842|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1772|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1773|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1774|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1775|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1776|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1777|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1778|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1779|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1780|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1781|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1782|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1783|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1784|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1785|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1786|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1787|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1788|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1789|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1790|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1791|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1792|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1889|NCT02628938|E1|Reported Event|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1793|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1794|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
1795|NCT02641379|O2|Outcome|PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1796|NCT02641379|O1|Outcome|PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1797|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1798|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1799|NCT02641379|E11|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1800|NCT02641379|E10|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
1801|NCT02641379|E9|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1802|NCT02641379|E8|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
1803|NCT02641379|E7|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1843|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1887|NCT02628938|E3|Reported Event|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1804|NCT02641379|E6|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1805|NCT02641379|E5|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1806|NCT02641379|E4|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
1807|NCT02641379|E3|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
1808|NCT02641379|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1809|NCT02641379|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
1810|NCT02638051|B3|Baseline|Total|Total of all reporting groups
1811|NCT02638051|B2|Baseline|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
1812|NCT02638051|B1|Baseline|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1813|NCT02638051|P2|Participant Flow|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
1814|NCT02638051|P1|Participant Flow|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1815|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
3351|NCT02540772|B2|Baseline|No Treatment|Patients in the control group only performed the baselines.
1816|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1817|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
1818|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1819|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
1820|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1821|NCT02638051|E2|Reported Event|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
1822|NCT02638051|E1|Reported Event|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
1823|NCT02635425|B3|Baseline|Total|Total of all reporting groups
1824|NCT02635425|B2|Baseline|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
1825|NCT02635425|B1|Baseline|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
1826|NCT02635425|P2|Participant Flow|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
1827|NCT02635425|P1|Participant Flow|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
1828|NCT02635425|O2|Outcome|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
1829|NCT02635425|O1|Outcome|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
1830|NCT02635425|E2|Reported Event|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
1831|NCT02635425|E1|Reported Event|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
1832|NCT02633787|B1|Baseline|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
1833|NCT02633787|P1|Participant Flow|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
1834|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
1835|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
1836|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
1837|NCT02633787|E1|Reported Event|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
1888|NCT02628938|E2|Reported Event|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
1844|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1845|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1846|NCT02630563|E1|Reported Event|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
1847|NCT02628418|B3|Baseline|Total|Total of all reporting groups
1848|NCT02628418|B2|Baseline|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific Hand Rehabilitation (SHR) performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1849|NCT02628418|B1|Baseline|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1850|NCT02628418|P2|Participant Flow|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1851|NCT02628418|P1|Participant Flow|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1852|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1853|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1854|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1855|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
2143|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
1856|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1857|NCT02628418|O1|Outcome|Gloreha Group|"TThe patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1858|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1859|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1860|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1861|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR on performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1862|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1863|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1864|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1884|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1885|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
9055|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
1865|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1866|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1867|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1868|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1869|NCT02628418|E2|Reported Event|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
1870|NCT02628418|E1|Reported Event|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
1871|NCT02628938|B4|Baseline|Total|Total of all reporting groups
1872|NCT02628938|B3|Baseline|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1873|NCT02628938|B2|Baseline|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
1874|NCT02628938|B1|Baseline|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1875|NCT02628938|P3|Participant Flow|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1876|NCT02628938|P2|Participant Flow|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
1877|NCT02628938|P1|Participant Flow|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1878|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1879|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
1880|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1881|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
1882|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
1883|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
1890|NCT02628106|B1|Baseline|Lipo-prostaglandin E1|"all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.~Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days"
1891|NCT02628106|P1|Participant Flow|Diabetic Nephropathy,Chronic Kidney Disease|all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
1892|NCT02628106|O1|Outcome|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
1893|NCT02628106|E1|Reported Event|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
1894|NCT02627144|B1|Baseline|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1895|NCT02627144|P1|Participant Flow|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1896|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1897|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1898|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1899|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1900|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1901|NCT02627144|E1|Reported Event|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
1902|NCT02627001|B3|Baseline|Total|Total of all reporting groups
1903|NCT02627001|B2|Baseline|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device.~Bag Valve Mask: Conventional bag valve mask"
1904|NCT02627001|B1|Baseline|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
1905|NCT02627001|P2|Participant Flow|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask.~Bag Valve Mask: Conventional bag valve mask"
1906|NCT02627001|P1|Participant Flow|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
2422|NCT02587117|B2|Baseline|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
1907|NCT02627001|O2|Outcome|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
1908|NCT02627001|O1|Outcome|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
1909|NCT02627001|E2|Reported Event|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
1910|NCT02627001|E1|Reported Event|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
1911|NCT02625844|B1|Baseline|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
1912|NCT02625844|P1|Participant Flow|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
1913|NCT02625844|O1|Outcome|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
1914|NCT02625844|E1|Reported Event|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
1915|NCT02621034|B4|Baseline|Total|Total of all reporting groups
1916|NCT02621034|B3|Baseline|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1917|NCT02621034|B2|Baseline|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1918|NCT02621034|B1|Baseline|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
1919|NCT02621034|P3|Participant Flow|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1920|NCT02621034|P2|Participant Flow|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1921|NCT02621034|P1|Participant Flow|k File|"hand instrumentation~k file: hand instrumentation"
1922|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1923|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1924|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
1925|NCT02621034|O2|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1926|NCT02621034|O1|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1927|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1928|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1929|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
1930|NCT02621034|E3|Reported Event|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
1931|NCT02621034|E2|Reported Event|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
1932|NCT02621034|E1|Reported Event|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
1933|NCT02619799|B3|Baseline|Total|Total of all reporting groups
1934|NCT02619799|B2|Baseline|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1935|NCT02619799|B1|Baseline|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1936|NCT02619799|P2|Participant Flow|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1937|NCT02619799|P1|Participant Flow|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1938|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1939|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1940|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1941|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1942|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1943|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1944|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1945|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1946|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1947|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1948|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1949|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1950|NCT02619799|E2|Reported Event|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1951|NCT02619799|E1|Reported Event|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
1952|NCT02619591|B3|Baseline|Total|Total of all reporting groups
1953|NCT02619591|B2|Baseline|Ultrasound Imaging - Multiple Views|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
1954|NCT02619591|B1|Baseline|Ultrasound Imaging - Single View|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
1955|NCT02619591|P2|Participant Flow|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
1956|NCT02619591|P1|Participant Flow|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
1957|NCT02619591|O2|Outcome|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
1958|NCT02619591|O1|Outcome|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
1959|NCT02619591|E2|Reported Event|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
1985|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1960|NCT02619591|E1|Reported Event|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
1961|NCT02618772|B3|Baseline|Total|Total of all reporting groups
1962|NCT02618772|B2|Baseline|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1963|NCT02618772|B1|Baseline|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1964|NCT02618772|P2|Participant Flow|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1965|NCT02618772|P1|Participant Flow|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1966|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1967|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1968|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1969|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1970|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1971|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1972|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1973|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1974|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1975|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1976|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1977|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1978|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1979|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1980|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1981|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1982|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1983|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1984|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
2063|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
1986|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1987|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1988|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1989|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1990|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1991|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1992|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1993|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1994|NCT02618772|E2|Reported Event|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
1995|NCT02618772|E1|Reported Event|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
1996|NCT02617888|B3|Baseline|Total|Total of all reporting groups
1997|NCT02617888|B2|Baseline|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
1998|NCT02617888|B1|Baseline|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
1999|NCT02617888|P2|Participant Flow|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
2000|NCT02617888|P1|Participant Flow|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
2001|NCT02617888|O2|Outcome|Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
2002|NCT02617888|O1|Outcome|No Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
2003|NCT02617888|E2|Reported Event|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
2004|NCT02617888|E1|Reported Event|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
2005|NCT02617784|B3|Baseline|Total|Total of all reporting groups
2006|NCT02617784|B2|Baseline|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2007|NCT02617784|B1|Baseline|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2008|NCT02617784|P2|Participant Flow|Oseltamivir With CAPD|Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2009|NCT02617784|P1|Participant Flow|Oseltamivir With HD|Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2010|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2011|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2012|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2013|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2014|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
5844|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
2015|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2016|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2017|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2018|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2019|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2020|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2021|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2022|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2023|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2024|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2025|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2026|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2027|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2028|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2029|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2030|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2031|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2032|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2033|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2034|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2035|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2036|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2037|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2038|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2064|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
2065|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
2039|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2040|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2041|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2042|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2043|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2044|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2045|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2046|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2047|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2048|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2049|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2050|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2051|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2052|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2053|NCT02617784|E2|Reported Event|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
2054|NCT02617784|E1|Reported Event|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
2055|NCT02616523|B4|Baseline|Total|Total of all reporting groups
2056|NCT02616523|B3|Baseline|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2057|NCT02616523|B2|Baseline|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2058|NCT02616523|B1|Baseline|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2059|NCT02616523|P3|Participant Flow|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2060|NCT02616523|P2|Participant Flow|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2061|NCT02616523|P1|Participant Flow|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2062|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
2068|NCT02616523|O3|Outcome|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2069|NCT02616523|O2|Outcome|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2070|NCT02616523|O1|Outcome|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2071|NCT02616523|E3|Reported Event|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2072|NCT02616523|E2|Reported Event|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2073|NCT02616523|E1|Reported Event|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
2074|NCT02615717|B3|Baseline|Total|Total of all reporting groups
2075|NCT02615717|B2|Baseline|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2076|NCT02615717|B1|Baseline|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2077|NCT02615717|P2|Participant Flow|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2078|NCT02615717|P1|Participant Flow|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2079|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2080|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2081|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2107|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
9056|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
2082|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2083|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2084|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2085|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2086|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2087|NCT02615717|E2|Reported Event|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
2088|NCT02615717|E1|Reported Event|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
2089|NCT02614924|B3|Baseline|Total|Total of all reporting groups
2090|NCT02614924|B2|Baseline|Pentax AWS Videolaryngoscope Group|Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
2091|NCT02614924|B1|Baseline|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
2092|NCT02614924|P2|Participant Flow|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
2093|NCT02614924|P1|Participant Flow|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
2094|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
2095|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
2096|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|randomly allocated to Pentax AWs
2097|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
2098|NCT02614924|E2|Reported Event|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS group Pentax AWS videolaryngoscope group: Patient intubated with Pentax AWS
2099|NCT02614924|E1|Reported Event|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
2100|NCT02612077|B1|Baseline|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
2101|NCT02612077|P1|Participant Flow|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
2102|NCT02612077|O1|Outcome|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
2103|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
2104|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
2105|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
2106|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
2108|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
2109|NCT02612077|E1|Reported Event|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
2110|NCT02611765|B3|Baseline|Total|Total of all reporting groups
2111|NCT02611765|B2|Baseline|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
2112|NCT02611765|B1|Baseline|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
2113|NCT02611765|P2|Participant Flow|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
2114|NCT02611765|P1|Participant Flow|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
2115|NCT02611765|O2|Outcome|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
2116|NCT02611765|O1|Outcome|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
2117|NCT02611765|E2|Reported Event|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
2118|NCT02611765|E1|Reported Event|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
2119|NCT02610634|B3|Baseline|Total|Total of all reporting groups
2120|NCT02610634|B2|Baseline|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
2121|NCT02610634|B1|Baseline|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
2122|NCT02610634|P2|Participant Flow|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
2123|NCT02610634|P1|Participant Flow|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
2124|NCT02610634|O2|Outcome|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
2125|NCT02610634|O1|Outcome|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
2126|NCT02610634|E2|Reported Event|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
2127|NCT02610634|E1|Reported Event|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
2128|NCT02609178|B1|Baseline|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
2129|NCT02609178|P6|Participant Flow|CON First, Then AVR, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
2130|NCT02609178|P5|Participant Flow|CON First, Then FGP, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.
2131|NCT02609178|P4|Participant Flow|AVR First, Then CON, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.
2132|NCT02609178|P3|Participant Flow|AVR First, Then FGP, Then CON|Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.
2133|NCT02609178|P2|Participant Flow|FGP First, Then CON, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.
2134|NCT02609178|P1|Participant Flow|FGP First, Then AVR, Then CON|Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.
2135|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
2136|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
2137|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
2138|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
2139|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
2140|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
2141|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
2142|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
9057|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
2144|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
2145|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
2146|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
2147|NCT02609178|E1|Reported Event|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
2148|NCT02608489|B3|Baseline|Total|Total of all reporting groups
2149|NCT02608489|B2|Baseline|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2150|NCT02608489|B1|Baseline|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2151|NCT02608489|P2|Participant Flow|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2152|NCT02608489|P1|Participant Flow|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2153|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2154|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2155|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2156|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2157|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2158|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2159|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2160|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2161|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2162|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2163|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2164|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2165|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2166|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2167|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2168|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2169|NCT02608489|E2|Reported Event|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
2170|NCT02608489|E1|Reported Event|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
2171|NCT02606734|B1|Baseline|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
2172|NCT02606734|P1|Participant Flow|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
2173|NCT02606734|O1|Outcome|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
2174|NCT02606734|E1|Reported Event|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
2175|NCT02603666|B1|Baseline|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
2176|NCT02603666|P1|Participant Flow|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
2177|NCT02603666|O1|Outcome|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
2178|NCT02603666|E1|Reported Event|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
2179|NCT02602223|B1|Baseline|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
2180|NCT02602223|P1|Participant Flow|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
2181|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2182|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2183|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2184|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2185|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2218|NCT02598128|P4|Participant Flow|Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)|Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
2186|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2187|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2188|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2189|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2190|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2191|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2192|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2193|NCT02602223|E2|Reported Event|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
9058|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
2194|NCT02602223|E1|Reported Event|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
2195|NCT02598934|B3|Baseline|Total|Total of all reporting groups
2196|NCT02598934|B2|Baseline|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
2197|NCT02598934|B1|Baseline|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
2198|NCT02598934|P2|Participant Flow|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
2199|NCT02598934|P1|Participant Flow|Ibandronate (Consult Group)|Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
2200|NCT02598934|O2|Outcome|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
2201|NCT02598934|O1|Outcome|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
2202|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
2203|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
2204|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
2205|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
2206|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
2207|NCT02598934|E1|Reported Event|Ibandronate (All Participants)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
2208|NCT02598622|B3|Baseline|Total|Total of all reporting groups
2209|NCT02598622|B2|Baseline|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
2210|NCT02598622|B1|Baseline|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
2211|NCT02598622|P2|Participant Flow|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
2212|NCT02598622|P1|Participant Flow|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
2213|NCT02598622|O2|Outcome|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
2214|NCT02598622|O1|Outcome|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
2215|NCT02598622|E2|Reported Event|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
2216|NCT02598622|E1|Reported Event|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
2217|NCT02598128|B1|Baseline|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
2219|NCT02598128|P3|Participant Flow|Crossover Period B: RELiZORB Then Placebo|Eligible subjects were randomized to RELiZORB then Placebo.
2220|NCT02598128|P2|Participant Flow|Crossover Period B: Placebo Then RELiZORB|Eligible subjects were randomized to Placebo then RELiZORB.
2221|NCT02598128|P1|Participant Flow|Period A: Clinical Treatment Practice (Days -7 to -1)|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
2222|NCT02598128|O1|Outcome|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
2223|NCT02598128|O2|Outcome|Control|Subjects receiving placebo at any time in the study.
2224|NCT02598128|O1|Outcome|RELiZORB|Subjects receiving RELiZORB at any time in the study.
2225|NCT02598128|O4|Outcome|Clinical Treatment Practice + RELiZORB: Period C: Days 12-20|Non-gastrointestinal adverse events during CTP+RELiZORB administration.
2226|NCT02598128|O3|Outcome|Crossover Period B: RELiZORB|Non-gastrointestinal adverse events during administration.
2227|NCT02598128|O2|Outcome|Crossover Period B: Placebo|Non-gastrointestinal adverse events during administration.
2228|NCT02598128|O1|Outcome|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
2229|NCT02598128|E3|Reported Event|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
2230|NCT02598128|E2|Reported Event|Double-Blind Crossover: Period B: Days 1 to 11|Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10.
2231|NCT02598128|E1|Reported Event|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
2232|NCT02597855|B3|Baseline|Total|Total of all reporting groups
2233|NCT02597855|B2|Baseline|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2234|NCT02597855|B1|Baseline|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2235|NCT02597855|P2|Participant Flow|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2236|NCT02597855|P1|Participant Flow|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2237|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2238|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2334|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2239|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2240|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2241|NCT02597855|E2|Reported Event|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2242|NCT02597855|E1|Reported Event|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
2243|NCT02597582|B3|Baseline|Total|Total of all reporting groups
2244|NCT02597582|B2|Baseline|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2245|NCT02597582|B1|Baseline|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2246|NCT02597582|P2|Participant Flow|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2247|NCT02597582|P1|Participant Flow|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2248|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2249|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2250|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2251|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2252|NCT02597582|O2|Outcome|Conventional Neck Dissection|"The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2253|NCT02597582|O1|Outcome|Ligusure Assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2254|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2255|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2256|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2277|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
2335|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2257|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2258|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2259|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2260|NCT02597582|E2|Reported Event|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
2261|NCT02597582|E1|Reported Event|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
2262|NCT02596958|B1|Baseline|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2263|NCT02596958|P1|Participant Flow|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).
2264|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2265|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2266|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2267|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2268|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2269|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2270|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2271|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2272|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2273|NCT02596958|E1|Reported Event|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
2274|NCT02596945|B1|Baseline|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
2275|NCT02596945|P1|Participant Flow|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
2276|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
9059|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
2278|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
2279|NCT02596945|E1|Reported Event|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
2280|NCT02596620|B3|Baseline|Total|Total of all reporting groups
2281|NCT02596620|B2|Baseline|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
2282|NCT02596620|B1|Baseline|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
2283|NCT02596620|P2|Participant Flow|Triple Therapy|levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
2284|NCT02596620|P1|Participant Flow|Sequential Therapy|esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
2285|NCT02596620|O2|Outcome|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
2286|NCT02596620|O1|Outcome|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
2287|NCT02596620|E2|Reported Event|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
2288|NCT02596620|E1|Reported Event|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
2289|NCT02595502|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
2290|NCT02595502|P2|Participant Flow|Senofilcon A/Delefilcon A/Senofilcon A|Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
2291|NCT02595502|P1|Participant Flow|Delefilcon A /Senofilcon A/Delefilcon A|Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
2292|NCT02595502|O2|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
2293|NCT02595502|O1|Outcome|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
2294|NCT02595502|E2|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
2295|NCT02595502|E1|Reported Event|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
2296|NCT02595450|B1|Baseline|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2297|NCT02595450|P1|Participant Flow|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2298|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2299|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2300|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2301|NCT02595450|E1|Reported Event|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
2302|NCT02594826|B3|Baseline|Total|Total of all reporting groups
2303|NCT02594826|B2|Baseline|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
2304|NCT02594826|B1|Baseline|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
2305|NCT02594826|P2|Participant Flow|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
2306|NCT02594826|P1|Participant Flow|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
2307|NCT02594826|O2|Outcome|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
2308|NCT02594826|O1|Outcome|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
2309|NCT02594826|E2|Reported Event|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
2310|NCT02594826|E1|Reported Event|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
2311|NCT02591238|B5|Baseline|Total|Total of all reporting groups
2312|NCT02591238|B4|Baseline|Ismoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2313|NCT02591238|B3|Baseline|IIsmoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2314|NCT02591238|B2|Baseline|IIInon-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2315|NCT02591238|B1|Baseline|IVnon-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2316|NCT02591238|P4|Participant Flow|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2317|NCT02591238|P3|Participant Flow|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2318|NCT02591238|P2|Participant Flow|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2319|NCT02591238|P1|Participant Flow|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2320|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2321|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2322|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2323|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2324|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2325|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2326|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2327|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2328|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2329|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2330|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2331|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2332|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2333|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2336|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2337|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2338|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2339|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2340|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2341|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2342|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2343|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2344|NCT02591238|E4|Reported Event|Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2345|NCT02591238|E3|Reported Event|Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
2346|NCT02591238|E2|Reported Event|Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
2347|NCT02591238|E1|Reported Event|Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
2348|NCT02591056|B1|Baseline|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
2349|NCT02591056|P1|Participant Flow|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
2350|NCT02591056|O1|Outcome|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
2351|NCT02591056|E1|Reported Event|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
2352|NCT02590562|B1|Baseline|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2353|NCT02590562|P1|Participant Flow|Overall Population|Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
2354|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2355|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2356|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2357|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2358|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2359|NCT02590562|O2|Outcome|Biological Agent as Combination With csDMARDs|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent with concomitant csDMARDs.
2360|NCT02590562|O1|Outcome|Biological Agent as Monotherapy|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs.
2361|NCT02590562|O4|Outcome|Duration of Biological Treatment >=12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=12 months.
2362|NCT02590562|O3|Outcome|Duration of Biological Treatment >=6 to <12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=6 to <12 months.
2363|NCT02590562|O2|Outcome|Duration of Biological Treatment >=3 to <6 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months.
2364|NCT02590562|O1|Outcome|Duration of Biological Treatment <3 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months.
2365|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2366|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2367|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2368|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2369|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2370|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2371|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2372|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2373|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2374|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2375|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2376|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2377|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2378|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2379|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2380|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2381|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2382|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2383|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2384|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2385|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2386|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2387|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2388|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2420|NCT02587819|E1|Reported Event|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2389|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2390|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2391|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2392|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2393|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2394|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2395|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2396|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2397|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2398|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2399|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2400|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2401|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2402|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2403|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2404|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2405|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2406|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2407|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2408|NCT02590562|E1|Reported Event|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
2409|NCT02588599|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
2410|NCT02588599|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
2411|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
2412|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
2413|NCT02588599|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
2414|NCT02587819|B1|Baseline|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2415|NCT02587819|P1|Participant Flow|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2416|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2417|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2418|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
2419|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
2421|NCT02587117|B3|Baseline|Total|Total of all reporting groups
2423|NCT02587117|B1|Baseline|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
2424|NCT02587117|P2|Participant Flow|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
2425|NCT02587117|P1|Participant Flow|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
2426|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
2427|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
2428|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
2429|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
2430|NCT02587117|E2|Reported Event|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
2431|NCT02587117|E1|Reported Event|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
2432|NCT02586506|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2433|NCT02586506|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2434|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2435|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2436|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2437|NCT02586506|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
2438|NCT02586493|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2439|NCT02586493|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2440|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2441|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2442|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2443|NCT02586493|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
2444|NCT02584686|B3|Baseline|Total|Total of all reporting groups
2445|NCT02584686|B2|Baseline|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2446|NCT02584686|B1|Baseline|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2447|NCT02584686|P2|Participant Flow|Control Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2448|NCT02584686|P1|Participant Flow|Study Group|"The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2449|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2450|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2451|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2452|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2453|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2454|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2455|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2456|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2457|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2458|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2864|NCT02563093|P1|Participant Flow|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2459|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2460|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2461|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2462|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2463|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2464|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2465|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2466|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2467|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2468|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2469|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2470|NCT02584686|O1|Outcome|(BTX) A|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2471|NCT02584686|E2|Reported Event|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
2472|NCT02584686|E1|Reported Event|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
2473|NCT02582983|B1|Baseline|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
2474|NCT02582983|P1|Participant Flow|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
2475|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
2476|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
2477|NCT02582983|E1|Reported Event|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
2478|NCT02581475|B3|Baseline|Total|Total of all reporting groups
2479|NCT02581475|B2|Baseline|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2999|NCT02553629|P2|Participant Flow|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
2480|NCT02581475|B1|Baseline|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2481|NCT02581475|P2|Participant Flow|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2482|NCT02581475|P1|Participant Flow|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2483|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2484|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2485|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2486|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2487|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2488|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2489|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2490|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2491|NCT02581475|E2|Reported Event|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
2492|NCT02581475|E1|Reported Event|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
2493|NCT02580799|B1|Baseline|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2494|NCT02580799|P1|Participant Flow|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2495|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2496|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2497|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2498|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2499|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2500|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2501|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2502|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2503|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2504|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2505|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2506|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2507|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2508|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2509|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2510|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2511|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2512|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2513|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2514|NCT02580799|E1|Reported Event|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
2515|NCT02578992|B3|Baseline|Total|Total of all reporting groups
2516|NCT02578992|B2|Baseline|Neutral Position|The patients’ head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique
2786|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2517|NCT02578992|B1|Baseline|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
2518|NCT02578992|P2|Participant Flow|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
2519|NCT02578992|P1|Participant Flow|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
2520|NCT02578992|O2|Outcome|Head-lift Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
2521|NCT02578992|O1|Outcome|Neutral Head Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
2522|NCT02578992|O2|Outcome|Head-lift Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
2523|NCT02578992|O1|Outcome|Neutral Head Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
2524|NCT02578992|O2|Outcome|Head-lift Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
2525|NCT02578992|O1|Outcome|Neutral Head Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
2526|NCT02578992|O2|Outcome|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
2527|NCT02578992|O1|Outcome|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
2528|NCT02578992|E2|Reported Event|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
2529|NCT02578992|E1|Reported Event|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
2530|NCT02577315|B3|Baseline|Total|Total of all reporting groups
2531|NCT02577315|B2|Baseline|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
2532|NCT02577315|B1|Baseline|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
2533|NCT02577315|P2|Participant Flow|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
2626|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2534|NCT02577315|P1|Participant Flow|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
2535|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2536|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2537|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2538|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2539|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2540|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2541|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2542|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2543|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2544|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2545|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2546|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2547|NCT02577315|E2|Reported Event|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2548|NCT02577315|E1|Reported Event|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
2549|NCT02576535|B1|Baseline|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2550|NCT02576535|P1|Participant Flow|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2551|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2552|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2553|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2554|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2555|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2556|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2557|NCT02576535|E1|Reported Event|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
2558|NCT02576145|B3|Baseline|Total|Total of all reporting groups
2559|NCT02576145|B2|Baseline|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2560|NCT02576145|B1|Baseline|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2561|NCT02576145|P2|Participant Flow|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2562|NCT02576145|P1|Participant Flow|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2563|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2564|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2565|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2566|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2567|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2568|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2569|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2570|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2571|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2862|NCT02563093|P3|Participant Flow|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2572|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2573|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2574|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2575|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2576|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2577|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2578|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2579|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2580|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2581|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2582|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2583|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2584|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2585|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2586|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2587|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2588|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2589|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2627|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
3136|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
2590|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2591|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2592|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2593|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2594|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2595|NCT02576145|E2|Reported Event|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
2596|NCT02576145|E1|Reported Event|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
2597|NCT02576041|B1|Baseline|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
2598|NCT02576041|P1|Participant Flow|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
2599|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
2600|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
2601|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
2602|NCT02576041|E1|Reported Event|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
2603|NCT02574845|B7|Baseline|Total|Total of all reporting groups
2604|NCT02574845|B6|Baseline|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2605|NCT02574845|B5|Baseline|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2606|NCT02574845|B4|Baseline|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2607|NCT02574845|B3|Baseline|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2608|NCT02574845|B2|Baseline|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2628|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
3137|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
2609|NCT02574845|B1|Baseline|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2610|NCT02574845|P6|Participant Flow|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2611|NCT02574845|P5|Participant Flow|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2612|NCT02574845|P4|Participant Flow|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2613|NCT02574845|P3|Participant Flow|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2614|NCT02574845|P2|Participant Flow|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2615|NCT02574845|P1|Participant Flow|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
2616|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2617|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2618|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2619|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2620|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2621|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2622|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2623|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2624|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2625|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2764|NCT02569996|E1|Reported Event|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2765|NCT02568852|B3|Baseline|Total|Total of all reporting groups
2629|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2630|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2631|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2632|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2633|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2634|NCT02574845|E6|Reported Event|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2635|NCT02574845|E5|Reported Event|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2636|NCT02574845|E4|Reported Event|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2637|NCT02574845|E3|Reported Event|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2638|NCT02574845|E2|Reported Event|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2639|NCT02574845|E1|Reported Event|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
2640|NCT02574260|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2641|NCT02574260|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2642|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2643|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2644|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2645|NCT02574260|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
2646|NCT02572752|B4|Baseline|Total|Total of all reporting groups
2647|NCT02572752|B3|Baseline|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2648|NCT02572752|B2|Baseline|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2649|NCT02572752|B1|Baseline|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2650|NCT02572752|P3|Participant Flow|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2651|NCT02572752|P2|Participant Flow|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2652|NCT02572752|P1|Participant Flow|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
2653|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2654|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2655|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
2656|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2657|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2658|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
2659|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2660|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
2661|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
2662|NCT02572752|E2|Reported Event|Nintedanib, Reference Treatment (R1 & R2)|Subjects were treated twice with single oral dose of nintedanib soft gelatine capsule (Reference treatment (R1 & R2)), 200 mg (2x100mg) with about 240 mL of water.
2663|NCT02572752|E1|Reported Event|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose of nintedanib soft gelatine capsule (Test treatment (T)) , 200 mg (1x200mg) with about 240 mL of water.
2664|NCT02572609|B3|Baseline|Total|Total of all reporting groups
2665|NCT02572609|B2|Baseline|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
2666|NCT02572609|B1|Baseline|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
2667|NCT02572609|P2|Participant Flow|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
2668|NCT02572609|P1|Participant Flow|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
2669|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
2670|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
2671|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
2672|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
2673|NCT02572609|E2|Reported Event|Ambroxol Hydrochloride Soft Pastille|
2674|NCT02572609|E1|Reported Event|Mucosolvan® Adult Syrup|
2675|NCT02572427|B3|Baseline|Total|Total of all reporting groups
2676|NCT02572427|B2|Baseline|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
2677|NCT02572427|B1|Baseline|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
2678|NCT02572427|P2|Participant Flow|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
2766|NCT02568852|B2|Baseline|Group 2|Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
2767|NCT02568852|B1|Baseline|Group 1|Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
2679|NCT02572427|P1|Participant Flow|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
2680|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
2681|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
2682|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
2683|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
2684|NCT02572427|E2|Reported Event|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
2685|NCT02572427|E1|Reported Event|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
2686|NCT02571634|B1|Baseline|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
2687|NCT02571634|P1|Participant Flow|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
2688|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
2689|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
2690|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
2691|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
2692|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
2693|NCT02571634|E1|Reported Event|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
2694|NCT02570425|B3|Baseline|Total|Total of all reporting groups
2695|NCT02570425|B2|Baseline|Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2768|NCT02568852|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
2769|NCT02568852|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy under general anaesthesia
2770|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2771|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
3138|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
2696|NCT02570425|B1|Baseline|SYMBICORT Turbohaler® First, Then Spiromax®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2697|NCT02570425|P2|Participant Flow|Placebo Comparator: Turbohaler Followed by Spiromax|Training on SYMBICORT Turbohaler followed by BF Spiromax
2698|NCT02570425|P1|Participant Flow|Placebo Comparator: Spiromax Followed by Turbohaler|Training on BF Spiromax followed by SYMBICORT Turbohaler
2699|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2700|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2701|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2702|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2703|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2704|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2772|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2773|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2774|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
3139|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
2705|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2706|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2707|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2708|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2709|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2710|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2711|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2712|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2775|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2776|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2713|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2714|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2715|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2716|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2717|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2718|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2719|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2777|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2778|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
3140|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
2720|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2721|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
2722|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2723|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2724|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2725|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2726|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2779|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2780|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2781|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2727|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2728|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2729|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2730|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2731|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2732|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2733|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2782|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2783|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2734|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2735|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2736|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2737|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2738|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2739|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2740|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2784|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2785|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2741|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2742|NCT02570425|E2|Reported Event|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
2743|NCT02570425|E1|Reported Event|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
2744|NCT02570022|B3|Baseline|Total|Total of all reporting groups
2745|NCT02570022|B2|Baseline|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
2746|NCT02570022|B1|Baseline|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
2747|NCT02570022|P2|Participant Flow|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
2748|NCT02570022|P1|Participant Flow|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
2749|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
2750|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
2751|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
2752|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
2753|NCT02570022|E2|Reported Event|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
2754|NCT02570022|E1|Reported Event|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
2755|NCT02569996|B1|Baseline|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2756|NCT02569996|P1|Participant Flow|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2757|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2758|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2759|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2760|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2761|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2762|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
2763|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
3141|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
2787|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2788|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2789|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2790|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2791|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2792|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2793|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2794|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2795|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2796|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2797|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2798|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2799|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2800|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
2801|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
2802|NCT02568852|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
2803|NCT02568852|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)
2804|NCT02568345|B1|Baseline|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
2805|NCT02568345|P1|Participant Flow|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
2806|NCT02568345|O1|Outcome|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
2807|NCT02568345|E1|Reported Event|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
2808|NCT02567188|B1|Baseline|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2809|NCT02567188|P1|Participant Flow|Chronic Kidney Disease (CKD) Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2810|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2811|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2812|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2813|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2814|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2815|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2816|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2817|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2818|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2819|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2820|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2821|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2822|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2823|NCT02567188|O1|Outcome|Cohort of CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2824|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2825|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2826|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2827|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2828|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2829|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2830|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2831|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2832|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2833|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2834|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2835|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2836|NCT02567188|E1|Reported Event|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
2837|NCT02563834|B3|Baseline|Total|Total of all reporting groups
2838|NCT02563834|B2|Baseline|Type 2 Diabetes|Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
2839|NCT02563834|B1|Baseline|Lean Controls|Lean non-diabetic control participants, taking no regular medications.
2840|NCT02563834|P2|Participant Flow|Type 2 DM|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2863|NCT02563093|P2|Participant Flow|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
3142|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
2841|NCT02563834|P1|Participant Flow|Lean Control|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
2842|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2843|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2844|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
2845|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
2846|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2847|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2848|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
2849|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
2850|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2851|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
2852|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
2853|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
2854|NCT02563834|E2|Reported Event|Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
2855|NCT02563834|E1|Reported Event|Saline|"Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
2856|NCT02563093|B5|Baseline|Total|Total of all reporting groups
2857|NCT02563093|B4|Baseline|Fluzone High-Dose Vaccine|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2858|NCT02563093|B3|Baseline|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2859|NCT02563093|B2|Baseline|Fluzone Quadrivalent Intradermal Vaccine|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2860|NCT02563093|B1|Baseline|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2861|NCT02563093|P4|Participant Flow|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
3143|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
2865|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2866|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2867|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2868|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2869|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2870|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2871|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2872|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2873|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2874|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2875|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2876|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2877|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2878|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2879|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2880|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2881|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2882|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2883|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2884|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2885|NCT02563093|E4|Reported Event|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
2886|NCT02563093|E3|Reported Event|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2887|NCT02563093|E2|Reported Event|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
2888|NCT02563093|E1|Reported Event|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
2889|NCT02561572|B3|Baseline|Total|Total of all reporting groups
2890|NCT02561572|B2|Baseline|Control|No intervention for 30 minutes.
2891|NCT02561572|B1|Baseline|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2892|NCT02561572|P2|Participant Flow|Control|No intervention for 30 minutes.
2893|NCT02561572|P1|Participant Flow|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2894|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2895|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2896|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2897|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2898|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2899|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2900|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2901|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2902|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2903|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2904|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
2905|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2906|NCT02561572|E2|Reported Event|Control|No intervention for 30 minutes.
2907|NCT02561572|E1|Reported Event|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
2959|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2960|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2908|NCT02557646|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2909|NCT02557646|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2910|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2911|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2912|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2913|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2914|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2915|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2916|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2917|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2918|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2919|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2920|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2921|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2922|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2923|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
3144|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
2924|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2925|NCT02557646|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
2926|NCT02556307|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2927|NCT02556307|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
2928|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2929|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2930|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2931|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2932|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2933|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2934|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2935|NCT02556307|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
2936|NCT02555618|B3|Baseline|Total|Total of all reporting groups
2937|NCT02555618|B2|Baseline|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2938|NCT02555618|B1|Baseline|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2939|NCT02555618|P2|Participant Flow|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2940|NCT02555618|P1|Participant Flow|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2941|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2942|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2943|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2944|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2945|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2946|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2947|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2948|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2949|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2950|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2951|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2952|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2953|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2954|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2955|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2956|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2957|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2958|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
3145|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
2961|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2962|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2963|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2964|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2965|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2966|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2967|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2968|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2969|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2970|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2971|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2972|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2973|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2974|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2975|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2976|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2977|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2978|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2979|NCT02555618|E2|Reported Event|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
2980|NCT02555618|E1|Reported Event|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
2981|NCT02555228|B3|Baseline|Total|Total of all reporting groups
2982|NCT02555228|B2|Baseline|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy."
2983|NCT02555228|B1|Baseline|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy."
2984|NCT02555228|P2|Participant Flow|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2985|NCT02555228|P1|Participant Flow|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2986|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2987|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2988|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2989|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2990|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2991|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2992|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2993|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2994|NCT02555228|E2|Reported Event|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2995|NCT02555228|E1|Reported Event|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
2996|NCT02553629|B3|Baseline|Total|Total of all reporting groups
2997|NCT02553629|B2|Baseline|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
2998|NCT02553629|B1|Baseline|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3000|NCT02553629|P1|Participant Flow|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3001|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3002|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3003|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3004|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3005|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3006|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3007|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3008|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3009|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3010|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3011|NCT02553629|E2|Reported Event|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
3012|NCT02553629|E1|Reported Event|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
3013|NCT02553421|B3|Baseline|Total|Total of all reporting groups
3014|NCT02553421|B2|Baseline|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
3015|NCT02553421|B1|Baseline|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
3016|NCT02553421|P2|Participant Flow|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
3017|NCT02553421|P1|Participant Flow|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
3018|NCT02553421|O1|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
3019|NCT02553421|O2|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
3020|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
3021|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
3022|NCT02553421|E2|Reported Event|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
3023|NCT02553421|E1|Reported Event|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
3024|NCT02552810|B3|Baseline|Total|Total of all reporting groups
3025|NCT02552810|B2|Baseline|Control Group|Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
3026|NCT02552810|B1|Baseline|Test Group|Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
3146|NCT02549027|E5|Reported Event|Placebo|Single dose of placebo
3027|NCT02552810|P2|Participant Flow|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3028|NCT02552810|P1|Participant Flow|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3029|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3030|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3031|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3032|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3033|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3034|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3035|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3036|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3037|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3147|NCT02549027|E4|Reported Event|MK-6096 20 mg|Single dose of 20 mg MK-6096
3148|NCT02549027|E3|Reported Event|MK-1064 250 mg|Single dose of 250 mg MK-1064
3038|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3039|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3040|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3041|NCT02552810|E2|Reported Event|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
3042|NCT02552810|E1|Reported Event|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
3043|NCT02551887|B4|Baseline|Total|Total of all reporting groups
3044|NCT02551887|B3|Baseline|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
3045|NCT02551887|B2|Baseline|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
3046|NCT02551887|B1|Baseline|Usual Care|Non-interventional study arm. Patients receive usual care.
3047|NCT02551887|P3|Participant Flow|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
3048|NCT02551887|P2|Participant Flow|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
3049|NCT02551887|P1|Participant Flow|Usual Care|Non-interventional study arm. Patients receive usual care.
3050|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
3051|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
3052|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
3053|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
3054|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
3055|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
3056|NCT02551887|E3|Reported Event|Automated Reminder Plus Recommended Script|In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
3057|NCT02551887|E2|Reported Event|Automated Reminder|Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
3058|NCT02551887|E1|Reported Event|Usual Care|Patients receive usual care.
3059|NCT02550197|B3|Baseline|Total|Total of all reporting groups
3060|NCT02550197|B2|Baseline|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3061|NCT02550197|B1|Baseline|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3062|NCT02550197|P2|Participant Flow|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3063|NCT02550197|P1|Participant Flow|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3064|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3065|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3066|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3067|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3068|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3069|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3070|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3071|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3072|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3073|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3074|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3075|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3076|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3077|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3078|NCT02550197|E2|Reported Event|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
3079|NCT02550197|E1|Reported Event|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
3080|NCT02550132|B1|Baseline|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3081|NCT02550132|P1|Participant Flow|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3082|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3083|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3084|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3085|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3086|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3149|NCT02549027|E2|Reported Event|MK-1064 120 mg|Single dose of 120 mg MK-1064
3150|NCT02549027|E1|Reported Event|MK-1064 50 mg|Single dose of 50 mg MK-1064
3151|NCT02549014|B3|Baseline|Total|Total of all reporting groups
3087|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3088|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3089|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3090|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3091|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3092|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3093|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3094|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3095|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3096|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3097|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3098|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3099|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3100|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3101|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3172|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
9060|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
3102|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3103|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3104|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3105|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3106|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3107|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3108|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3109|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3110|NCT02550132|E1|Reported Event|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
3111|NCT02549027|B1|Baseline|All Study Participants|
3112|NCT02549027|P6|Participant Flow|Placebo (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.
3113|NCT02549027|P5|Participant Flow|MK-6096 20 mg (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.
3114|NCT02549027|P4|Participant Flow|MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)|Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
3115|NCT02549027|P3|Participant Flow|MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)|Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
3116|NCT02549027|P2|Participant Flow|MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)|Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
3117|NCT02549027|P1|Participant Flow|MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)|Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
3118|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
3119|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
3120|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
3121|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
3122|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
3123|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
3124|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
3125|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
3126|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
3127|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
3128|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
3129|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
3130|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
3131|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
3132|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
3133|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
3134|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
3135|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
3152|NCT02549014|B2|Baseline|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
3153|NCT02549014|B1|Baseline|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
3154|NCT02549014|P2|Participant Flow|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
3155|NCT02549014|P1|Participant Flow|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
3156|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3157|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3158|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3159|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3160|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3161|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3162|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3163|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3164|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3165|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3166|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3167|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3168|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3169|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3170|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3171|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3347|NCT02540850|E3|Reported Event|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3348|NCT02540850|E2|Reported Event|Precancerous Disease Group|subjects with adenoma or polyps
3173|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3174|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3175|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3176|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3177|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3178|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3179|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3180|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3181|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3182|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3183|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3184|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3185|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3186|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3187|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3188|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3189|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3190|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3191|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3192|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3193|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3194|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3195|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3196|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3197|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3198|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3349|NCT02540850|E1|Reported Event|CRC Group|stage 0-IV CRC subjects
3199|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3200|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3201|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3202|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3203|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3204|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3205|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3206|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3207|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3208|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3209|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3210|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3211|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3212|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3213|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3214|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3215|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3216|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3217|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3218|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3219|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3220|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3221|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3222|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3223|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3224|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3225|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3226|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3227|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3228|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3229|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3230|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3231|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3232|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3233|NCT02549014|E11|Reported Event|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
3234|NCT02549014|E10|Reported Event|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
3235|NCT02549014|E9|Reported Event|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
3236|NCT02549014|E8|Reported Event|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3237|NCT02549014|E7|Reported Event|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3238|NCT02549014|E6|Reported Event|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3239|NCT02549014|E5|Reported Event|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3240|NCT02549014|E4|Reported Event|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3241|NCT02549014|E3|Reported Event|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3242|NCT02549014|E2|Reported Event|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3243|NCT02549014|E1|Reported Event|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
3244|NCT02548156|B1|Baseline|Overall Study|All the participants randomized in this study.
3245|NCT02548156|P6|Participant Flow|Sequence 6: Reference/Comparator/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3246|NCT02548156|P5|Participant Flow|Sequence 5: Reference/Test/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3247|NCT02548156|P4|Participant Flow|Sequence 4: Comparator/Reference/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3277|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3350|NCT02540772|B3|Baseline|Total|Total of all reporting groups
3248|NCT02548156|P3|Participant Flow|Sequence 3: Comparator/Test/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3249|NCT02548156|P2|Participant Flow|Sequence 2: Test/Reference/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3250|NCT02548156|P1|Participant Flow|Sequence 1: Test/Comparator/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
3251|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3252|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
3253|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3254|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3255|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
3256|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3257|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3258|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
3259|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3260|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3261|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
3262|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3263|NCT02548156|E3|Reported Event|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3264|NCT02548156|E2|Reported Event|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
3265|NCT02548156|E1|Reported Event|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
3266|NCT02547454|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3267|NCT02547454|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
3268|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3269|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3270|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3271|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3272|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3273|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3274|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3275|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3276|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3278|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3279|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3280|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3281|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3282|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3283|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3284|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3285|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3286|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3287|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3288|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3289|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3290|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3291|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3292|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3293|NCT02547454|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
3294|NCT02543918|B3|Baseline|Total|Total of all reporting groups
3295|NCT02543918|B2|Baseline|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3296|NCT02543918|B1|Baseline|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3297|NCT02543918|P2|Participant Flow|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
3298|NCT02543918|P1|Participant Flow|Ixekizumab + Boostrix® + Pneumovax®23|"Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.~Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2."
3299|NCT02543918|O2|Outcome|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3300|NCT02543918|O1|Outcome|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3301|NCT02543918|E2|Reported Event|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3302|NCT02543918|E1|Reported Event|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
3303|NCT02542280|B3|Baseline|Total|Total of all reporting groups
3304|NCT02542280|B2|Baseline|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3305|NCT02542280|B1|Baseline|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3343|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3344|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3306|NCT02542280|P2|Participant Flow|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3307|NCT02542280|P1|Participant Flow|Endometrial Injury|"Endometrial injury during ovarian stimulation cycle combined with intrauterine insemination.~endometrial injury: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3308|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3309|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3310|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3311|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3312|NCT02542280|E2|Reported Event|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3313|NCT02542280|E1|Reported Event|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
3314|NCT02543437|B1|Baseline|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
3315|NCT02543437|P1|Participant Flow|Trident Acetabular X3 Insert|Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
3316|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
3317|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
3318|NCT02543437|E1|Reported Event|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
3319|NCT02540850|B4|Baseline|Total|Total of all reporting groups
3320|NCT02540850|B3|Baseline|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3321|NCT02540850|B2|Baseline|Precancerous Disease Group|subjects with adenoma or polyps
3322|NCT02540850|B1|Baseline|CRC Group|stage 0-IV CRC subjects
3323|NCT02540850|P3|Participant Flow|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3324|NCT02540850|P2|Participant Flow|Precancerous Disease Group|subjects with adenoma or polyps
3325|NCT02540850|P1|Participant Flow|CRC Group|stage 0-IV CRC subjects
3326|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3327|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3328|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3329|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3330|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3331|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3332|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3333|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3334|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3335|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3336|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3337|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3338|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3339|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3340|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
3341|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
3342|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
3352|NCT02540772|B1|Baseline|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3353|NCT02540772|P2|Participant Flow|No Treatment|Patients in the control group only performed the baselines.
3354|NCT02540772|P1|Participant Flow|Neuropsychological Treatment|"The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.~Neuropsychological treatment: Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors. This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment."
3355|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
3356|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3357|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
3358|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3359|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
3360|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3361|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
3362|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3363|NCT02540772|E2|Reported Event|No Treatment|Patients in the control group only performed the baselines.
3364|NCT02540772|E1|Reported Event|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
3365|NCT02540447|B3|Baseline|Total|Total of all reporting groups
3366|NCT02540447|B2|Baseline|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3367|NCT02540447|B1|Baseline|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3368|NCT02540447|P2|Participant Flow|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3369|NCT02540447|P1|Participant Flow|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3370|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3371|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3372|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3497|NCT02536664|B1|Baseline|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3373|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3374|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3375|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3376|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3377|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3378|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3379|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3380|NCT02540447|E2|Reported Event|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
3381|NCT02540447|E1|Reported Event|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
3382|NCT02540213|B1|Baseline|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3383|NCT02540213|P1|Participant Flow|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
3384|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3385|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3386|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
9061|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
3387|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3388|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3389|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3390|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3391|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3392|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3393|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3394|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3395|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3396|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3397|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3398|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3399|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3400|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3401|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3424|NCT02539992|O1|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3402|NCT02540213|E1|Reported Event|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
3403|NCT02539992|B4|Baseline|Total|Total of all reporting groups
3404|NCT02539992|B3|Baseline|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3405|NCT02539992|B2|Baseline|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3406|NCT02539992|B1|Baseline|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3407|NCT02539992|P3|Participant Flow|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3408|NCT02539992|P2|Participant Flow|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3409|NCT02539992|P1|Participant Flow|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3410|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3411|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3412|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3413|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3414|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3415|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3416|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3417|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3418|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3419|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3420|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3421|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3422|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3423|NCT02539992|O2|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3425|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3426|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3427|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3428|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3429|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3430|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3431|NCT02539992|E3|Reported Event|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
3432|NCT02539992|E2|Reported Event|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
3433|NCT02539992|E1|Reported Event|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
3434|NCT02539108|B3|Baseline|Total|Total of all reporting groups
3435|NCT02539108|B2|Baseline|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3436|NCT02539108|B1|Baseline|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3437|NCT02539108|P2|Participant Flow|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3438|NCT02539108|P1|Participant Flow|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3439|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3440|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3441|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3442|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3443|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3444|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3445|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3446|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3572|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
9062|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
3447|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3448|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3449|NCT02539108|E2|Reported Event|3 to <9 Years of Age|Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3450|NCT02539108|E1|Reported Event|6 to <36 Months of Age|Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
3451|NCT02538107|B1|Baseline|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3452|NCT02538107|P1|Participant Flow|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3453|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3454|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3455|NCT02538107|O2|Outcome|GFR (30-60 mL/Min)-Kidney Transplant Participants|Participants with GFR in the range of 30-60 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3456|NCT02538107|O1|Outcome|GFR (<30 mL/Min)-Kidney Transplant Participants|Participants with GFR <30 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3457|NCT02538107|O2|Outcome|Presence of Acute Bleeding-Kidney Transplant Participants|Participants with presence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3458|NCT02538107|O1|Outcome|Absence of Acute Bleeding-Kidney Transplant Participants|Participants with absence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3459|NCT02538107|O2|Outcome|Other Reason-Kidney Transplant Participants|Participants with unspecified other reasons as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3460|NCT02538107|O1|Outcome|Glomerulonephritis-Kidney Transplant Participants|Participants with glomerulonephritis as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3461|NCT02538107|O2|Outcome|Inflammatory Diseases Absent-Kidney Transplant Participants|Participants with chronic kidney disease and absence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3462|NCT02538107|O1|Outcome|Inflammatory Diseases Present-Kidney Transplant Participants|Participants with chronic kidney disease and presence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3463|NCT02538107|O2|Outcome|Cadaveric Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3464|NCT02538107|O1|Outcome|Living Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'living donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3465|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3466|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3467|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3468|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3469|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3470|NCT02538107|E1|Reported Event|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
3471|NCT02537730|B1|Baseline|Overall Participants|Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
3472|NCT02537730|P2|Participant Flow|Aosept Clearcare Combo, Then Bioclean MPS VII Combo|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3473|NCT02537730|P1|Participant Flow|Bioclean MPS VII Combo, Then Aosept Clearcare Combo|"Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3474|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3475|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3476|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3477|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3478|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3479|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3480|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3481|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3482|NCT02537730|E2|Reported Event|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
3483|NCT02537730|E1|Reported Event|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
3484|NCT02537522|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the course of the study.
3485|NCT02537522|P4|Participant Flow|Control/Test - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
3486|NCT02537522|P3|Participant Flow|Test/Control - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.
3487|NCT02537522|P2|Participant Flow|Control/Test - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.
3488|NCT02537522|P1|Participant Flow|Test/Control - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.
3489|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
3490|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
3491|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during Phase II.
3492|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during Phase II.
3493|NCT02537522|E2|Reported Event|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
3494|NCT02537522|E1|Reported Event|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
3495|NCT02536664|B3|Baseline|Total|Total of all reporting groups
3496|NCT02536664|B2|Baseline|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
9063|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
3498|NCT02536664|P2|Participant Flow|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3499|NCT02536664|P1|Participant Flow|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3500|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3501|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3502|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3503|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3504|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3505|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3506|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3507|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3508|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3509|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3510|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3511|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3512|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3513|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3514|NCT02536664|E2|Reported Event|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3515|NCT02536664|E1|Reported Event|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
3516|NCT02535741|B1|Baseline|Triathlon CR Total Knee System|Progressive data: Primary total knee replacement
3517|NCT02535741|P1|Participant Flow|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
3518|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
3519|NCT02535741|E1|Reported Event|Triathlon CR Total Knee System|Triathlon CR Primary total knee replacement
3520|NCT02534324|B3|Baseline|Total|Total of all reporting groups
3521|NCT02534324|B2|Baseline|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3522|NCT02534324|B1|Baseline|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3523|NCT02534324|P2|Participant Flow|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
9064|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
3524|NCT02534324|P1|Participant Flow|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3525|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3526|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3527|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3528|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3529|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3530|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3531|NCT02534324|E2|Reported Event|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3532|NCT02534324|E1|Reported Event|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
3533|NCT02533401|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3534|NCT02533401|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3535|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3536|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3537|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3538|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3573|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3574|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3539|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3540|NCT02533401|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
3541|NCT02531646|B4|Baseline|Total|Total of all reporting groups
3542|NCT02531646|B3|Baseline|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3543|NCT02531646|B2|Baseline|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3544|NCT02531646|B1|Baseline|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3545|NCT02531646|P3|Participant Flow|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3546|NCT02531646|P2|Participant Flow|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3547|NCT02531646|P1|Participant Flow|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3548|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3549|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3550|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3551|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3552|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3553|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3575|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3576|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
9065|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
3554|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3555|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3556|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3557|NCT02531646|E3|Reported Event|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3558|NCT02531646|E2|Reported Event|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3559|NCT02531646|E1|Reported Event|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
3560|NCT02531308|B1|Baseline|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
3561|NCT02531308|P1|Participant Flow|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
3562|NCT02531308|O1|Outcome|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
3563|NCT02531308|E1|Reported Event|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
3564|NCT02530671|B3|Baseline|Total|Total of all reporting groups
3565|NCT02530671|B2|Baseline|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3566|NCT02530671|B1|Baseline|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3567|NCT02530671|P2|Participant Flow|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3568|NCT02530671|P1|Participant Flow|Manual Toothbrush|"ADA (American Dental Association) reference manual toothbrush~Toothbrushing with manual toothbrush"
3569|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3570|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3571|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3577|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3578|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3579|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3580|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3581|NCT02530671|E2|Reported Event|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
3582|NCT02530671|E1|Reported Event|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
3583|NCT02530450|B3|Baseline|Total|Total of all reporting groups
3584|NCT02530450|B2|Baseline|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3585|NCT02530450|B1|Baseline|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3586|NCT02530450|P2|Participant Flow|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3587|NCT02530450|P1|Participant Flow|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3588|NCT02530450|O2|Outcome|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3589|NCT02530450|O1|Outcome|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3590|NCT02530450|E2|Reported Event|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3591|NCT02530450|E1|Reported Event|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
3592|NCT02528331|B1|Baseline|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3593|NCT02528331|P1|Participant Flow|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3594|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3595|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3596|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3597|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3598|NCT02528331|E1|Reported Event|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
3599|NCT02528097|B3|Baseline|Total|Total of all reporting groups
3600|NCT02528097|B2|Baseline|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
3601|NCT02528097|B1|Baseline|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
3602|NCT02528097|P2|Participant Flow|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
3603|NCT02528097|P1|Participant Flow|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
3632|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3985|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3604|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
3605|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
3606|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
3607|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
3608|NCT02528097|E2|Reported Event|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
3609|NCT02528097|E1|Reported Event|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
3610|NCT02527161|B1|Baseline|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3611|NCT02527161|P1|Participant Flow|ShapeMatch® Cutting Guides With Triathlon®|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3612|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3613|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3614|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3615|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3616|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3617|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3618|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3619|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3620|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3621|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3622|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3623|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3624|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3625|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3626|NCT02527161|E1|Reported Event|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
3627|NCT02527148|B3|Baseline|Total|Total of all reporting groups
3628|NCT02527148|B2|Baseline|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3629|NCT02527148|B1|Baseline|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3630|NCT02527148|P2|Participant Flow|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3631|NCT02527148|P1|Participant Flow|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3633|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3634|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3635|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3636|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3637|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3638|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3639|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3640|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3641|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3642|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3643|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3644|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3645|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3646|NCT02527148|E2|Reported Event|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
3647|NCT02527148|E1|Reported Event|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
3648|NCT02526550|B1|Baseline|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3649|NCT02526550|P1|Participant Flow|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3650|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3651|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3652|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3674|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3740|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3653|NCT02526550|E1|Reported Event|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
3654|NCT02525536|B4|Baseline|Total|Total of all reporting groups
3655|NCT02525536|B3|Baseline|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3656|NCT02525536|B2|Baseline|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3657|NCT02525536|B1|Baseline|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3658|NCT02525536|P3|Participant Flow|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3659|NCT02525536|P2|Participant Flow|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3660|NCT02525536|P1|Participant Flow|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3661|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3662|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3663|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3664|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3665|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3666|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3667|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3668|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3669|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3670|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3671|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3672|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3673|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3675|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3676|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3677|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3678|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3679|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3680|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3681|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3682|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3683|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3684|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3685|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3686|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3687|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3688|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3689|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3690|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3691|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3692|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3693|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3694|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3695|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
5599|NCT02454127|E2|Reported Event|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
3696|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3697|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3698|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3699|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3700|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3701|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3702|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3703|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3704|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3705|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3706|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3707|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3708|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3709|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3710|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3711|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3712|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3713|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3714|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3715|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3716|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
5600|NCT02454127|E1|Reported Event|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
3717|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3718|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3719|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3720|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3721|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3722|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3723|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3724|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3725|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3726|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3727|NCT02525536|E3|Reported Event|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3728|NCT02525536|E2|Reported Event|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3729|NCT02525536|E1|Reported Event|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
3730|NCT02522624|B3|Baseline|Total|Total of all reporting groups
3731|NCT02522624|B2|Baseline|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3732|NCT02522624|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3733|NCT02522624|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3734|NCT02522624|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3735|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3736|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3737|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3738|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3739|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3779|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3741|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3742|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3743|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3744|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3745|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3746|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3747|NCT02522624|E2|Reported Event|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
3748|NCT02522624|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
3749|NCT02519855|B3|Baseline|Total|Total of all reporting groups
3750|NCT02519855|B2|Baseline|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3751|NCT02519855|B1|Baseline|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3752|NCT02519855|P2|Participant Flow|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3753|NCT02519855|P1|Participant Flow|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3754|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3755|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3756|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3757|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3758|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3759|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3760|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3761|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3762|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3763|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3764|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3765|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3766|NCT02519855|E2|Reported Event|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
3767|NCT02519855|E1|Reported Event|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
3768|NCT02519595|B4|Baseline|Total|Total of all reporting groups
3769|NCT02519595|B3|Baseline|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3770|NCT02519595|B2|Baseline|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3771|NCT02519595|B1|Baseline|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3772|NCT02519595|P3|Participant Flow|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3773|NCT02519595|P2|Participant Flow|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3774|NCT02519595|P1|Participant Flow|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3775|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3776|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3777|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3778|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
5601|NCT02454101|B3|Baseline|Total|Total of all reporting groups
3780|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3781|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3782|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3783|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3784|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3785|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3786|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3787|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3788|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3789|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3790|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3791|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3792|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3793|NCT02519595|E3|Reported Event|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
3794|NCT02519595|E2|Reported Event|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
3795|NCT02519595|E1|Reported Event|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
3796|NCT02519387|B1|Baseline|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3797|NCT02519387|P1|Participant Flow|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3798|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3799|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3800|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3801|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3802|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3803|NCT02519387|E1|Reported Event|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
3804|NCT02516163|B1|Baseline|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
3805|NCT02516163|P1|Participant Flow|Shapematch Cutting Guides|The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study.
3806|NCT02516163|O1|Outcome|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
3807|NCT02516163|E1|Reported Event|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only.~Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study"
3808|NCT02516098|B3|Baseline|Total|Total of all reporting groups
3986|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3809|NCT02516098|B2|Baseline|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
3810|NCT02516098|B1|Baseline|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
3811|NCT02516098|P2|Participant Flow|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
3812|NCT02516098|P1|Participant Flow|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
3813|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
3814|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
3815|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
3816|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
3817|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
3818|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
3819|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
3820|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
3821|NCT02516098|E2|Reported Event|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
3822|NCT02516098|E1|Reported Event|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
3823|NCT02515994|B3|Baseline|Total|Total of all reporting groups
3824|NCT02515994|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3825|NCT02515994|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3826|NCT02515994|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3827|NCT02515994|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3828|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
3829|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
3830|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
3831|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
3832|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
3833|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
3834|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
3835|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
3836|NCT02515994|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
3837|NCT02515994|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
3838|NCT02515279|B1|Baseline|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
5672|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
3839|NCT02515279|P1|Participant Flow|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
3840|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
3841|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
3842|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
3843|NCT02515279|E1|Reported Event|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
3844|NCT02512783|B3|Baseline|Total|Total of all reporting groups
3845|NCT02512783|B2|Baseline|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3846|NCT02512783|B1|Baseline|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3847|NCT02512783|P2|Participant Flow|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3848|NCT02512783|P1|Participant Flow|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3849|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3850|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3851|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3852|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3853|NCT02512783|E2|Reported Event|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3854|NCT02512783|E1|Reported Event|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
3855|NCT02512679|B1|Baseline|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3856|NCT02512679|P2|Participant Flow|Cyclophosphamide Dose Level 2|"De-escalation of Cyclophosphamide given by Intravenous (IV) at a total dose of 70 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 75 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days. After ten patients the de-escalation will begin if the stopping rule is not met."
3899|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3857|NCT02512679|P1|Participant Flow|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3858|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3859|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3860|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3861|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3862|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3863|NCT02512679|E1|Reported Event|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
3864|NCT02512224|B3|Baseline|Total|Total of all reporting groups
3865|NCT02512224|B2|Baseline|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3866|NCT02512224|B1|Baseline|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3867|NCT02512224|P2|Participant Flow|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3868|NCT02512224|P1|Participant Flow|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3869|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3870|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3871|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3872|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3873|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3900|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3874|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3875|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3876|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3877|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3878|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3879|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3880|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3881|NCT02512224|E2|Reported Event|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3882|NCT02512224|E1|Reported Event|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
3883|NCT02510820|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
3884|NCT02510820|P2|Participant Flow|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
3885|NCT02510820|P1|Participant Flow|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
3886|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3887|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3888|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3889|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3890|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3891|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3892|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3893|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3894|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3895|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3896|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3897|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3898|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3932|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3901|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3902|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3903|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3904|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3905|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3906|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3907|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3908|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3909|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3910|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3911|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3912|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3913|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3914|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3915|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3916|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3917|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens Synergi: Multipurpose solution"
3918|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
3919|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
3920|NCT02510820|E2|Reported Event|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution~Synergi: Multipurpose solution"
3921|NCT02510820|E1|Reported Event|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution~Biotrue: Multipurpose solution"
3922|NCT02507752|B1|Baseline|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3923|NCT02507752|P1|Participant Flow|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3924|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3925|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3926|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3927|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3928|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3929|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3930|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3931|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
5673|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
3933|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3934|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3935|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3936|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3937|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3938|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3939|NCT02507752|E1|Reported Event|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
3940|NCT02507375|B3|Baseline|Total|Total of all reporting groups
3941|NCT02507375|B2|Baseline|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
3942|NCT02507375|B1|Baseline|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
3943|NCT02507375|P2|Participant Flow|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
3944|NCT02507375|P1|Participant Flow|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
3945|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3946|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3947|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3948|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3949|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3950|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
3951|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
3952|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
6034|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
3953|NCT02507375|O3|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
3954|NCT02507375|O2|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
3955|NCT02507375|O1|Outcome|Total Population|Erlotinib + pertuzumab
3956|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
3957|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
3958|NCT02507375|E2|Reported Event|Cohort 2|Erlotinib 150 mg + pertuzumab 420 mg
3959|NCT02507375|E1|Reported Event|Cohort 1|Erlotinib 100 mg + pertuzumab 420 mg
3960|NCT02506881|B5|Baseline|Total|Total of all reporting groups
3961|NCT02506881|B4|Baseline|Aranesp → BCD-066 - Intravenous|Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
3962|NCT02506881|B3|Baseline|BCD-066 → Aranesp - Intravenous|Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
3963|NCT02506881|B2|Baseline|Aranesp → BCD-066 - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
3964|NCT02506881|B1|Baseline|BCD-066 → Aranesp - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
3965|NCT02506881|P4|Participant Flow|Aranesp → BCD-066 - Intravenous|"Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
3966|NCT02506881|P3|Participant Flow|BCD-066 → Aranesp - Intravenous|"Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
3967|NCT02506881|P2|Participant Flow|Aranesp → BCD-066 - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
3968|NCT02506881|P1|Participant Flow|BCD-066 → Aranesp - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
3969|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3970|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3971|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3972|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3973|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3974|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3975|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3976|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3977|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3978|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3979|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3980|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3981|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3982|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3983|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3984|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3987|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
3988|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
3989|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
3990|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
3991|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
3992|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
3993|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
3994|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
3995|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
3996|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
3997|NCT02506881|E4|Reported Event|Aranesp® - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
3998|NCT02506881|E3|Reported Event|BCD-066 - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
3999|NCT02506881|E2|Reported Event|Aranesp® Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
4000|NCT02506881|E1|Reported Event|BCD-066 Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
4001|NCT02506257|B5|Baseline|Total|Total of all reporting groups
4002|NCT02506257|B4|Baseline|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4003|NCT02506257|B3|Baseline|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4004|NCT02506257|B2|Baseline|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4005|NCT02506257|B1|Baseline|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4006|NCT02506257|P4|Participant Flow|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4007|NCT02506257|P3|Participant Flow|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4008|NCT02506257|P2|Participant Flow|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4009|NCT02506257|P1|Participant Flow|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4010|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4011|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4012|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4013|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4014|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4015|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4016|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
5674|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
4017|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4018|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4019|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4020|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4021|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4022|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4023|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4024|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4025|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4026|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4027|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4028|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4029|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4030|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4031|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4032|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4033|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4034|NCT02506257|E4|Reported Event|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4035|NCT02506257|E3|Reported Event|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4036|NCT02506257|E2|Reported Event|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4037|NCT02506257|E1|Reported Event|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
4038|NCT02504775|B1|Baseline|Overall Participants|Total number of participants who were randomized and received treatment.
4039|NCT02504775|P2|Participant Flow|Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)|Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
4040|NCT02504775|P1|Participant Flow|Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)|Participants first received one tablet of Tylenol® Caplets [500 milligram (mg) of paracetamol], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
4041|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
9066|NCT02367066|E2|Reported Event|Placebo|Placebo, oral tablet
4042|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4043|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4044|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4045|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4046|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4047|NCT02504775|O2|Outcome|Mejoral® 500 Tablets (Test)|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4048|NCT02504775|O1|Outcome|Tylenol® Caplets (Reference)|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
4049|NCT02504775|E2|Reported Event|Mejoral® 500 Tablets|Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
4050|NCT02504775|E1|Reported Event|Tylenol® Caplets|Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
4051|NCT02504320|B5|Baseline|Total|Total of all reporting groups
4052|NCT02504320|B4|Baseline|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
4053|NCT02504320|B3|Baseline|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
4054|NCT02504320|B2|Baseline|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
4055|NCT02504320|B1|Baseline|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
4056|NCT02504320|P4|Participant Flow|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
4057|NCT02504320|P3|Participant Flow|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
4058|NCT02504320|P2|Participant Flow|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
4059|NCT02504320|P1|Participant Flow|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
4060|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
4061|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
4062|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
9067|NCT02367066|E1|Reported Event|AZD1981|AZD1981, oral tablet
4063|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
4064|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
4065|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
4066|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
4067|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
4068|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
4069|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
4070|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
4071|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
4072|NCT02504320|E4|Reported Event|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
4073|NCT02504320|E3|Reported Event|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
4074|NCT02504320|E2|Reported Event|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
4075|NCT02504320|E1|Reported Event|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
4076|NCT02503982|B1|Baseline|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
4077|NCT02503982|P1|Participant Flow|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
4078|NCT02503982|O1|Outcome|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
4079|NCT02503982|E1|Reported Event|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
4080|NCT02503865|B4|Baseline|Total|Total of all reporting groups
4081|NCT02503865|B3|Baseline|Healthy People|64 healthy people
4082|NCT02503865|B2|Baseline|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4083|NCT02503865|B1|Baseline|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4084|NCT02503865|P3|Participant Flow|Healthy People|64 healthy people
4085|NCT02503865|P2|Participant Flow|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4086|NCT02503865|P1|Participant Flow|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4087|NCT02503865|O3|Outcome|Healthy People|64 healthy people
4088|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4089|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4090|NCT02503865|O3|Outcome|Healthy People|64 healthy people
4091|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4092|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4093|NCT02503865|O3|Outcome|Healthy People|64 healthy people
4094|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4095|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4096|NCT02503865|O3|Outcome|Healthy People|64 healthy people
7221|NCT02414828|E3|Reported Event|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
4097|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4098|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4099|NCT02503865|O3|Outcome|Healthy People|64 healthy people
4100|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4101|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4102|NCT02503865|E3|Reported Event|Healthy People|64 healthy people
4103|NCT02503865|E2|Reported Event|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
4104|NCT02503865|E1|Reported Event|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
4105|NCT02503215|B1|Baseline|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4106|NCT02503215|P1|Participant Flow|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4107|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4108|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4109|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4110|NCT02503215|E1|Reported Event|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
4111|NCT02502487|B4|Baseline|Total|Total of all reporting groups
4112|NCT02502487|B3|Baseline|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4113|NCT02502487|B2|Baseline|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4114|NCT02502487|B1|Baseline|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4115|NCT02502487|P3|Participant Flow|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4116|NCT02502487|P2|Participant Flow|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4117|NCT02502487|P1|Participant Flow|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4118|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4119|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
5602|NCT02454101|B2|Baseline|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
4120|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4121|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4122|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4123|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4124|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4125|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4126|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4127|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4128|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4129|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4130|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4131|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4132|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4133|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4134|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4135|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4136|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4137|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4138|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4139|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
9446|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
4140|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4141|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4142|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4143|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4144|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4145|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4146|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4147|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4148|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4149|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4150|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4151|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4152|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4153|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4154|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4155|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4156|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4157|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4158|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4159|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
7222|NCT02414828|E2|Reported Event|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
4160|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4161|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4162|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4163|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4164|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4165|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4166|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4167|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4168|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4169|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4170|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4171|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4172|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4173|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4174|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4175|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4176|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4177|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4178|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
4207|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4179|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
4180|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
4181|NCT02502487|E3|Reported Event|Combination Group|DPNB with ropivacaine plus tetracaine gel
4182|NCT02502487|E2|Reported Event|DPNB Group|DPNB with ropivacaine plus plain lubricant
4183|NCT02502487|E1|Reported Event|Tetracaine Group|tetracaine gel plus DPNB with saline
4184|NCT02502734|B1|Baseline|Fluticasone Furoate and Placebo in Any of the Two Sequences|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
4185|NCT02502734|P2|Participant Flow|Fluticasone Furoate Followed by Placebo|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
4186|NCT02502734|P1|Participant Flow|Placebo Followed by Fluticasone Furoate|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
4187|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
4188|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
4189|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
4190|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
4191|NCT02502734|E2|Reported Event|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
4192|NCT02502734|E1|Reported Event|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
4193|NCT02500368|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
4194|NCT02500368|P2|Participant Flow|Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)|"Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).~enfilcon A lens (control): contact lens~silicone hydrogel lens (test): contact lens"
4195|NCT02500368|P1|Participant Flow|Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).~silicone hydrogel lens (test): contact lens~enfilcon A lens (control): contact lens"
4196|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4197|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4198|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4199|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4200|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4201|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4202|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4203|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4204|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4205|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4206|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4208|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4209|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4210|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4211|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4212|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4213|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4214|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4215|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4216|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4217|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4218|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4219|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4220|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4221|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4222|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4223|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4224|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4225|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4226|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4227|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4228|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4229|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4230|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4231|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4232|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4233|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4234|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4235|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4236|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4237|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4238|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4239|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4240|NCT02500368|E2|Reported Event|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
4241|NCT02500368|E1|Reported Event|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
4242|NCT02499692|B1|Baseline|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4243|NCT02499692|P1|Participant Flow|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4244|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4245|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4246|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4247|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4248|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4249|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4250|NCT02499692|E1|Reported Event|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
4251|NCT02498678|B3|Baseline|Total|Total of all reporting groups
4252|NCT02498678|B2|Baseline|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4253|NCT02498678|B1|Baseline|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4254|NCT02498678|P2|Participant Flow|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4255|NCT02498678|P1|Participant Flow|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4256|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4257|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4258|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4259|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
5675|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
4260|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4261|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4262|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4263|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4264|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4265|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4266|NCT02498678|E2|Reported Event|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
4267|NCT02498678|E1|Reported Event|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
4268|NCT02498522|B3|Baseline|Total|Total of all reporting groups
4269|NCT02498522|B2|Baseline|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4270|NCT02498522|B1|Baseline|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4271|NCT02498522|P2|Participant Flow|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4272|NCT02498522|P1|Participant Flow|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4273|NCT02498522|O2|Outcome|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4274|NCT02498522|O1|Outcome|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4275|NCT02498522|E2|Reported Event|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4276|NCT02498522|E1|Reported Event|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
4277|NCT02496533|B3|Baseline|Total|Total of all reporting groups
4278|NCT02496533|B2|Baseline|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4296|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
9447|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
4279|NCT02496533|B1|Baseline|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4280|NCT02496533|P2|Participant Flow|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4281|NCT02496533|P1|Participant Flow|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4282|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4283|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4284|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4285|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4286|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4287|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4288|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4289|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4290|NCT02496533|E2|Reported Event|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
4291|NCT02496533|E1|Reported Event|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
4292|NCT02496221|B1|Baseline|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
4293|NCT02496221|P2|Participant Flow|Placebo Followed by Albiglutide 50 mg|Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
4294|NCT02496221|P1|Participant Flow|Albiglutide 50 mg Followed by Placebo|Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
4295|NCT02496221|O3|Outcome|Albiglutide 50 mg and Placebo|Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
5676|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
4297|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4298|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4299|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4300|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4301|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4302|NCT02496221|O1|Outcome|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of a cholecystokinin (sincalide) in each period.
4303|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4304|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4305|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4306|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4307|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4308|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4309|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4310|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4311|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4312|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4313|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4314|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4315|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4316|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4317|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4318|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4319|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4320|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4357|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
9448|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
4321|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4322|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4323|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4324|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4325|NCT02496221|E2|Reported Event|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4326|NCT02496221|E1|Reported Event|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
4327|NCT02496000|B4|Baseline|Total|Total of all reporting groups
4328|NCT02496000|B3|Baseline|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
4329|NCT02496000|B2|Baseline|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
4330|NCT02496000|B1|Baseline|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
4331|NCT02496000|P3|Participant Flow|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
4332|NCT02496000|P2|Participant Flow|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
4333|NCT02496000|P1|Participant Flow|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
4334|NCT02496000|O4|Outcome|ORMD-0801 Doses 1 and 2 Combined|The combined measurements of dose 1 and dose 2, in units of mg/dL
4335|NCT02496000|O3|Outcome|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
4336|NCT02496000|O2|Outcome|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
4337|NCT02496000|O1|Outcome|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
4338|NCT02496000|E3|Reported Event|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
4339|NCT02496000|E2|Reported Event|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
4340|NCT02496000|E1|Reported Event|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
4341|NCT02495948|B1|Baseline|Overall|Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
4342|NCT02495948|P2|Participant Flow|ULTRA Then AOA|Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
4343|NCT02495948|P1|Participant Flow|AOA Then ULTRA|Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
4344|NCT02495948|O2|Outcome|ULTRA|Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
4345|NCT02495948|O1|Outcome|AIR OPTIX AQUA (AOA)|Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
4346|NCT02495948|E3|Reported Event|ULTRA|All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
4347|NCT02495948|E2|Reported Event|AIR OPTIX AQUA|All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2
4348|NCT02495948|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
4349|NCT02495831|B1|Baseline|Intervention|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose"
4350|NCT02495831|P2|Participant Flow|Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
4351|NCT02495831|P1|Participant Flow|Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
4352|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
4353|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
4354|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
4355|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
4356|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
5677|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
4358|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
4359|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
4360|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
4361|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
4362|NCT02495831|E2|Reported Event|Diclofenac Sodium and Safinamide|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
4363|NCT02495831|E1|Reported Event|Diclofenac Sodium|Diclofenac sodium 50 mg oral tablets, single dose
4364|NCT02494596|B1|Baseline|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4365|NCT02494596|P3|Participant Flow|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4366|NCT02494596|P2|Participant Flow|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4367|NCT02494596|P1|Participant Flow|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4368|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4369|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4370|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4371|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4372|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4373|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4374|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4375|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4376|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4377|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4422|NCT02492165|P2|Participant Flow|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4378|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4379|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4380|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4381|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4382|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4383|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4384|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4385|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4386|NCT02494596|O1|Outcome|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4387|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4388|NCT02494596|E3|Reported Event|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4389|NCT02494596|E2|Reported Event|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4390|NCT02494596|E1|Reported Event|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
4391|NCT02494440|B1|Baseline|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4392|NCT02494440|P1|Participant Flow|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4393|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4394|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4423|NCT02492165|P1|Participant Flow|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4395|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4396|NCT02494440|E1|Reported Event|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
4397|NCT02494323|B1|Baseline|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
4398|NCT02494323|P1|Participant Flow|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
4399|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
4400|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
4401|NCT02494323|E1|Reported Event|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
4402|NCT02492451|B4|Baseline|Total|Total of all reporting groups
4403|NCT02492451|B3|Baseline|Control Group|Only intrauterine insemination
4404|NCT02492451|B2|Baseline|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
4405|NCT02492451|B1|Baseline|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
4406|NCT02492451|P3|Participant Flow|Control Group|Only intrauterine insemination
4407|NCT02492451|P2|Participant Flow|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
4408|NCT02492451|P1|Participant Flow|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
4409|NCT02492451|O3|Outcome|Control Group|Only intrauterine insemination
4410|NCT02492451|O2|Outcome|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
4411|NCT02492451|O1|Outcome|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
4412|NCT02492451|E3|Reported Event|Control Group|Only intrauterine insemination
4413|NCT02492451|E2|Reported Event|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
4414|NCT02492451|E1|Reported Event|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
4415|NCT02492165|B5|Baseline|Total|Total of all reporting groups
4416|NCT02492165|B4|Baseline|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4417|NCT02492165|B3|Baseline|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4418|NCT02492165|B2|Baseline|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4419|NCT02492165|B1|Baseline|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4420|NCT02492165|P4|Participant Flow|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4421|NCT02492165|P3|Participant Flow|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4424|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4425|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4426|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4427|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4428|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4429|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4430|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4431|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4432|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4433|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4434|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4435|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4436|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4437|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4438|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4439|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4440|NCT02492165|E4|Reported Event|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4441|NCT02492165|E3|Reported Event|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4442|NCT02492165|E2|Reported Event|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4443|NCT02492165|E1|Reported Event|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
4444|NCT02491944|B1|Baseline|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4445|NCT02491944|P1|Participant Flow|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4446|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4447|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4448|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4449|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4450|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4451|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4452|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4453|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4454|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4455|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4456|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4457|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4458|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4459|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4460|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4461|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4462|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4463|NCT02491944|E1|Reported Event|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
4464|NCT02491892|B3|Baseline|Total|Total of all reporting groups
4465|NCT02491892|B2|Baseline|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4466|NCT02491892|B1|Baseline|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4467|NCT02491892|P2|Participant Flow|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4468|NCT02491892|P1|Participant Flow|Pertuzumab 420 mg|Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4469|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4470|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4471|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4472|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4473|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4474|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4475|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4476|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4477|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4478|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4479|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4480|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4481|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4482|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4483|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4774|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4484|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4485|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4486|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4487|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4488|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4489|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4490|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4491|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4492|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4493|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4494|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4495|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4496|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4497|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4498|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4499|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4500|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4501|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4502|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4503|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4504|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4505|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4506|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4507|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4508|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4509|NCT02491892|E2|Reported Event|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
4510|NCT02491892|E1|Reported Event|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
4511|NCT02490670|B3|Baseline|Total|Total of all reporting groups
4512|NCT02490670|B2|Baseline|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
4513|NCT02490670|B1|Baseline|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
4514|NCT02490670|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
4515|NCT02490670|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
4516|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
4517|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
4518|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
4519|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
4520|NCT02490670|E2|Reported Event|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
4521|NCT02490670|E1|Reported Event|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
4522|NCT02490475|B5|Baseline|Total|Total of all reporting groups
4523|NCT02490475|B4|Baseline|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4524|NCT02490475|B3|Baseline|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4525|NCT02490475|B2|Baseline|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4526|NCT02490475|B1|Baseline|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4527|NCT02490475|P4|Participant Flow|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4528|NCT02490475|P3|Participant Flow|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4529|NCT02490475|P2|Participant Flow|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4530|NCT02490475|P1|Participant Flow|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4531|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4532|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
9449|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
4533|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4534|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4535|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4536|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4537|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4538|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4539|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4540|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4541|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4542|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4543|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4544|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4586|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4903|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4545|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4546|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4547|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4548|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4549|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4550|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4551|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4552|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4553|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4554|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4555|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4556|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4587|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
5603|NCT02454101|B1|Baseline|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
4557|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4558|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4559|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4560|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4561|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4562|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4563|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4564|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4565|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4566|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4567|NCT02490475|O4|Outcome|Docetaxel 75+ Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4568|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4588|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4589|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4569|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4570|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4571|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4572|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4573|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4574|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4575|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4576|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4577|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4578|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4579|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4580|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4581|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4582|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4583|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4584|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4585|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4590|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4591|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4592|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4593|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4594|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4595|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4596|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4597|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4598|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
4599|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
4600|NCT02490475|O1|Outcome|Entire Study Population|Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
4601|NCT02490475|E4|Reported Event|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4602|NCT02490475|E3|Reported Event|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4603|NCT02490475|E2|Reported Event|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4604|NCT02490475|E1|Reported Event|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
4605|NCT02488317|B3|Baseline|Total|Total of all reporting groups
4606|NCT02488317|B2|Baseline|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4607|NCT02488317|B1|Baseline|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4638|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
4656|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4608|NCT02488317|P2|Participant Flow|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4609|NCT02488317|P1|Participant Flow|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4610|NCT02488317|O1|Outcome|Intervention Post-test|Intervention arm after reviewing the decision aid
4611|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4612|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4613|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4614|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4615|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4616|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4617|NCT02488317|O3|Outcome|Control|Control arm with no decision aid.
4618|NCT02488317|O2|Outcome|Intervention Post-test|Intervention arm responses after accessing the decision aid (N=63)
4619|NCT02488317|O1|Outcome|Intervention Pre-test|Intervention arm responses prior to accessing the decision aid (N=70)
4620|NCT02488317|E2|Reported Event|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
4621|NCT02488317|E1|Reported Event|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
5604|NCT02454101|P2|Participant Flow|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
4622|NCT02488018|B1|Baseline|Provision of Experimental Honeys|Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
4623|NCT02488018|P1|Participant Flow|Honey Glycemic Index|"Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.~Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
4624|NCT02488018|O1|Outcome|Provision of Experimental Honeys|"Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.~25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
4625|NCT02488018|E1|Reported Event|Honey Glycemic Index|Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.
4626|NCT02486952|B1|Baseline|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
4627|NCT02486952|P1|Participant Flow|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
4628|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
4629|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
4630|NCT02486952|E1|Reported Event|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
4631|NCT02485483|B3|Baseline|Total|Total of all reporting groups
4632|NCT02485483|B2|Baseline|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
4633|NCT02485483|B1|Baseline|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4634|NCT02485483|P2|Participant Flow|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
4635|NCT02485483|P1|Participant Flow|VADERA I|Rheumatoid arthritis (RA) participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4636|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
4637|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
9450|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
4639|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4640|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4641|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4642|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4643|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4644|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4645|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4646|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4647|NCT02485483|E2|Reported Event|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
4648|NCT02485483|E1|Reported Event|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
4649|NCT02485158|B1|Baseline|Healthy Adult Volunteers|All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
4650|NCT02485158|P1|Participant Flow|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
4651|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4652|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4653|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4654|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4655|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
9451|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
4657|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4658|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4659|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4660|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4661|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4662|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4663|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4664|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4665|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4666|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4667|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4668|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4669|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4670|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4671|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4672|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4673|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4674|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4675|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4676|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4677|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
5663|NCT02451150|P1|Participant Flow|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
4678|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4679|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4680|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4681|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4682|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4683|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4684|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4685|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4686|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4687|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4688|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4689|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4690|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4691|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4692|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4693|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4694|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4695|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4696|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4697|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4698|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
5664|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
4699|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4700|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4701|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4702|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4703|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4704|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4705|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4706|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4707|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4708|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4709|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4710|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4711|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4712|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4713|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4714|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4715|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4716|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4717|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4718|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4719|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
5665|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
4720|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4721|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4722|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4723|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4724|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4725|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4726|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4727|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4728|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4729|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
4730|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
4731|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
4732|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
4733|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
4734|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
4735|NCT02485158|E1|Reported Event|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
4736|NCT02484898|B1|Baseline|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
4737|NCT02484898|P1|Participant Flow|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
4738|NCT02484898|O1|Outcome|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
4739|NCT02484898|E1|Reported Event|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
4740|NCT02483611|B4|Baseline|Total|Total of all reporting groups
4741|NCT02483611|B3|Baseline|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4742|NCT02483611|B2|Baseline|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4743|NCT02483611|B1|Baseline|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4744|NCT02483611|P3|Participant Flow|Group C (Control Group - Isotonic Solution)|This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
4745|NCT02483611|P2|Participant Flow|Group ML (Magnesium Sulfate Plus Lidocaine)|This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.
4746|NCT02483611|P1|Participant Flow|Group M (Magnesium Sulfate)|This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.
4747|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4748|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4749|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4750|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4751|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4752|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4753|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4754|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4755|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4756|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4757|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4758|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4759|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4760|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4761|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4762|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4763|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4764|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4765|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4766|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4767|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4768|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4769|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4770|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4771|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4772|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4773|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4775|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4776|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4777|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4778|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4779|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4780|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4781|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4782|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4783|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4784|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4785|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4786|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4787|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4788|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4789|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4790|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4791|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4792|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4793|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4794|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4795|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4796|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4797|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4798|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4799|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4800|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4801|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4802|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4803|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4804|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
9452|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
4805|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4806|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4807|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4808|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4809|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4810|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4811|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4812|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4813|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4814|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4815|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4816|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4817|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4818|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4819|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4820|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4821|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4822|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4823|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4824|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4825|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4826|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4827|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4828|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4829|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4830|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4831|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4832|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4833|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4834|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
9453|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
4835|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4836|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4837|NCT02483611|E3|Reported Event|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
4838|NCT02483611|E2|Reported Event|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
4839|NCT02483611|E1|Reported Event|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
4840|NCT02481934|B1|Baseline|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive: two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
4841|NCT02481934|P1|Participant Flow|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
4842|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
4843|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
4844|NCT02481934|E1|Reported Event|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
4845|NCT02481219|B3|Baseline|Total|Total of all reporting groups
4846|NCT02481219|B2|Baseline|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4847|NCT02481219|B1|Baseline|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4848|NCT02481219|P2|Participant Flow|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4849|NCT02481219|P1|Participant Flow|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4850|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4851|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4902|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
9454|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
4852|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4853|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4854|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4855|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4856|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4857|NCT02481219|O1|Outcome|Bowel Preparation Regimen - Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4858|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4859|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4860|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4861|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4862|NCT02481219|E2|Reported Event|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
4863|NCT02481219|E1|Reported Event|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
4864|NCT02480439|B4|Baseline|Total|Total of all reporting groups
4865|NCT02480439|B3|Baseline|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
4866|NCT02480439|B2|Baseline|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
4867|NCT02480439|B1|Baseline|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
4868|NCT02480439|P3|Participant Flow|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
4869|NCT02480439|P2|Participant Flow|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
4870|NCT02480439|P1|Participant Flow|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
4871|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4872|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4873|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4874|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4875|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4876|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4877|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4878|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4879|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4880|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4881|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4882|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4883|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4884|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4885|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4886|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4887|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4888|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4889|NCT02480439|E3|Reported Event|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4890|NCT02480439|E2|Reported Event|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
4891|NCT02480439|E1|Reported Event|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
4892|NCT02480010|B3|Baseline|Total|Total of all reporting groups
4893|NCT02480010|B2|Baseline|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4894|NCT02480010|B1|Baseline|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4895|NCT02480010|P2|Participant Flow|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4896|NCT02480010|P1|Participant Flow|Pertuzumab 420 Milligrams (mg) - Cohort A|Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4897|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4898|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4899|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4900|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4901|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
5666|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
4904|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4905|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4906|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4907|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4908|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4909|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4910|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4911|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4912|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4913|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4914|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4915|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4916|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4917|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4918|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4919|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4920|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4921|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4922|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4923|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4924|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4925|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4926|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4927|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4928|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4929|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
5041|NCT02475564|E1|Reported Event|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
4930|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4931|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4932|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4933|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4934|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4935|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4936|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4937|NCT02480010|E2|Reported Event|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
4938|NCT02480010|E1|Reported Event|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
4939|NCT02479763|B3|Baseline|Total|Total of all reporting groups
4940|NCT02479763|B2|Baseline|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
4941|NCT02479763|B1|Baseline|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
4942|NCT02479763|P2|Participant Flow|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
4943|NCT02479763|P1|Participant Flow|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
4944|NCT02479763|O2|Outcome|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
4945|NCT02479763|O1|Outcome|Conventional Loss-of-resistance|
4946|NCT02479763|E2|Reported Event|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
4947|NCT02479763|E1|Reported Event|Conventional Loss-of-resistance|
4948|NCT02478671|B1|Baseline|TR Band|MRI based Radial artery measurement
4949|NCT02478671|P1|Participant Flow|TR Band|MRI based radial artery measurement
4950|NCT02478671|O1|Outcome|TR Band|Pulse Oxymetry
4951|NCT02478671|O1|Outcome|TR Band|MRI based Radial artery measurement
4952|NCT02478671|E1|Reported Event|TR Band|MRI based radial artery measurement
4953|NCT02478580|B3|Baseline|Total|Total of all reporting groups
4954|NCT02478580|B2|Baseline|Control|Placebo in preoperative area
4955|NCT02478580|B1|Baseline|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
4956|NCT02478580|P2|Participant Flow|Control|Placebo in preoperative area
4957|NCT02478580|P1|Participant Flow|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
4958|NCT02478580|O2|Outcome|Control|Placebo in preoperative area
4959|NCT02478580|O1|Outcome|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
4960|NCT02478580|E2|Reported Event|Control|Placebo in preoperative area
4961|NCT02478580|E1|Reported Event|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
4962|NCT02478372|B3|Baseline|Total|Total of all reporting groups
4963|NCT02478372|B2|Baseline|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4964|NCT02478372|B1|Baseline|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
5042|NCT02475278|B1|Baseline|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
4965|NCT02478372|P2|Participant Flow|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4966|NCT02478372|P1|Participant Flow|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4967|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4968|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4969|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4970|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4971|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4972|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4973|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
5667|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
4974|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4975|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4976|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4977|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4978|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4979|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4980|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4981|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4982|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4999|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4983|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4984|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4985|NCT02478372|E2|Reported Event|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
4986|NCT02478372|E1|Reported Event|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
4987|NCT02476422|B3|Baseline|Total|Total of all reporting groups
4988|NCT02476422|B2|Baseline|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
4989|NCT02476422|B1|Baseline|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4990|NCT02476422|P2|Participant Flow|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
4991|NCT02476422|P1|Participant Flow|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4992|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
4993|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4994|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
4995|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4996|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
4997|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
4998|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
9455|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
5000|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5001|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5002|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5003|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5004|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5005|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5006|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5007|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5008|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5009|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5010|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5011|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5012|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5013|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5014|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5015|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5016|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5017|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5018|NCT02476422|E2|Reported Event|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
5019|NCT02476422|E1|Reported Event|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
5020|NCT02475980|B1|Baseline|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5021|NCT02475980|P1|Participant Flow|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5022|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5023|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5024|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5025|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5026|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5027|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5028|NCT02475980|E1|Reported Event|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
5029|NCT02475564|B3|Baseline|Total|Total of all reporting groups
5030|NCT02475564|B2|Baseline|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
5031|NCT02475564|B1|Baseline|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5032|NCT02475564|P2|Participant Flow|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5033|NCT02475564|P1|Participant Flow|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
5034|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
5035|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5036|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
5037|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5038|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
5039|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5040|NCT02475564|E2|Reported Event|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
5668|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5043|NCT02475278|P1|Participant Flow|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5044|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5045|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5046|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5047|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5048|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5049|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5050|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5051|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5052|NCT02475278|E1|Reported Event|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
5053|NCT02473510|B3|Baseline|Total|Total of all reporting groups
5054|NCT02473510|B2|Baseline|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5055|NCT02473510|B1|Baseline|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5056|NCT02473510|P2|Participant Flow|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5057|NCT02473510|P1|Participant Flow|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5058|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5059|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5060|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5061|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5062|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5063|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5064|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5065|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5066|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5067|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5068|NCT02473510|E2|Reported Event|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
5069|NCT02473510|E1|Reported Event|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
5070|NCT02473367|B1|Baseline|All Enrolled Participants|All participants who enrolled in the study
5175|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.
5669|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5071|NCT02473367|P1|Participant Flow|Four Period Fixed Sequence|All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
5072|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
5073|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
5074|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
5075|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
5076|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
5077|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
5078|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
5079|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
5080|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
5081|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
5082|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
5083|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
5084|NCT02473367|E4|Reported Event|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
5085|NCT02473367|E3|Reported Event|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
5086|NCT02473367|E2|Reported Event|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
5087|NCT02473367|E1|Reported Event|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
5088|NCT02472847|B3|Baseline|Total|Total of all reporting groups
5089|NCT02472847|B2|Baseline|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
5090|NCT02472847|B1|Baseline|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
5091|NCT02472847|P2|Participant Flow|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
5092|NCT02472847|P1|Participant Flow|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
5093|NCT02472847|O2|Outcome|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
5094|NCT02472847|O1|Outcome|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
5176|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury
9456|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
5095|NCT02472847|E2|Reported Event|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
5096|NCT02472847|E1|Reported Event|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
5097|NCT02472756|B1|Baseline|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5098|NCT02472756|P1|Participant Flow|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician’s discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5099|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5100|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5101|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5102|NCT02472756|E1|Reported Event|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
5103|NCT02472522|B3|Baseline|Total|Total of all reporting groups
5104|NCT02472522|B2|Baseline|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5105|NCT02472522|B1|Baseline|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5106|NCT02472522|P2|Participant Flow|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5107|NCT02472522|P1|Participant Flow|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5497|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5108|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5109|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5110|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5111|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5112|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5113|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5114|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5115|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5116|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5117|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5118|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5498|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5119|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5120|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5121|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5122|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5123|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5124|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5125|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5126|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5127|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5128|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5129|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5670|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5130|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5131|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5132|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5133|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5134|NCT02472522|E2|Reported Event|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
5135|NCT02472522|E1|Reported Event|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
5136|NCT02472366|B3|Baseline|Total|Total of all reporting groups
5137|NCT02472366|B2|Baseline|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5138|NCT02472366|B1|Baseline|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5139|NCT02472366|P2|Participant Flow|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5140|NCT02472366|P1|Participant Flow|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5141|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5142|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5143|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5144|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5145|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5146|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5147|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5148|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5149|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5150|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5151|NCT02472366|E2|Reported Event|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5152|NCT02472366|E1|Reported Event|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
5153|NCT02471755|B3|Baseline|Total|Total of all reporting groups
5154|NCT02471755|B2|Baseline|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5671|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5155|NCT02471755|B1|Baseline|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5156|NCT02471755|P2|Participant Flow|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5157|NCT02471755|P1|Participant Flow|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5158|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5159|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5160|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5161|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5162|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5163|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5177|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury
5164|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5165|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5166|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5167|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5168|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5169|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5170|NCT02471755|E2|Reported Event|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
5171|NCT02471755|E1|Reported Event|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
5172|NCT02471612|B1|Baseline|Emergency Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score & P-POSSUM Score
5173|NCT02471612|P1|Participant Flow|All Patients Who Underwent Emergency Exploratory Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
5174|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.
5586|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5178|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
5179|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
5180|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..
5181|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..
5182|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively
5183|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively
5184|NCT02471612|O1|Outcome|Length of Stay|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)
5185|NCT02471612|O2|Outcome|AUC Using P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.
5186|NCT02471612|O1|Outcome|AUC Using APACHE II|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
5187|NCT02471612|E2|Reported Event|P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery
5188|NCT02471612|E1|Reported Event|APACHE-2 Scoring|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
5189|NCT02470949|B1|Baseline|All Study Participants|High Social Status Condition in Monopoly Game and Low Social Status Condition in Monopoly Game
5190|NCT02470949|P2|Participant Flow|High Social Status, Then Low Social Status|High Social Status Condition in Monopoly Game during the first intervention period and Low Social Status Condition in Monopoly Game during the second intervention period (after washout period).
5191|NCT02470949|P1|Participant Flow|Low Social Status, Then High Social Status|Low Social Status Condition in Monopoly Game during the first intervention period and High Social Status Condition in Monopoly Game during the second intervention period (after washout period).
5192|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5193|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5194|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5195|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5196|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5197|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5198|NCT02470949|E2|Reported Event|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5199|NCT02470949|E1|Reported Event|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
5200|NCT02469961|B3|Baseline|Total|Total of all reporting groups
5201|NCT02469961|B2|Baseline|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5202|NCT02469961|B1|Baseline|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5203|NCT02469961|P2|Participant Flow|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5204|NCT02469961|P1|Participant Flow|Dexmedetomidne|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5205|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5206|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5207|NCT02469961|O2|Outcome|Dexmedetomidine|Patients who received Dexmedetomidine
5208|NCT02469961|O1|Outcome|Propofol|Patients who received Propofol
5209|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5210|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5211|NCT02469961|O2|Outcome|Propofol|Number of patients required airway manipulations
5212|NCT02469961|O1|Outcome|Dexmedetomidine|Number of patients required airway manipulation
5213|NCT02469961|E2|Reported Event|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5214|NCT02469961|E1|Reported Event|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
5215|NCT02469597|B3|Baseline|Total|Total of all reporting groups
5216|NCT02469597|B2|Baseline|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5217|NCT02469597|B1|Baseline|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5218|NCT02469597|P2|Participant Flow|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5219|NCT02469597|P1|Participant Flow|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5220|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5221|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5222|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5223|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5224|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5225|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5226|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5227|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5228|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5229|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5230|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5231|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5232|NCT02469597|E2|Reported Event|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
5233|NCT02469597|E1|Reported Event|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
5587|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5234|NCT02469116|B1|Baseline|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5235|NCT02469116|P1|Participant Flow|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5236|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5237|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5238|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5239|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5240|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5241|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5242|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5243|NCT02469116|E1|Reported Event|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
5244|NCT02468154|B3|Baseline|Total|Total of all reporting groups
5245|NCT02468154|B2|Baseline|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5246|NCT02468154|B1|Baseline|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5247|NCT02468154|P2|Participant Flow|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5248|NCT02468154|P1|Participant Flow|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5249|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5250|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5251|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5252|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5253|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5254|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5588|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
9457|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
5255|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5256|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5257|NCT02468154|E2|Reported Event|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
5258|NCT02468154|E1|Reported Event|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
5259|NCT02467491|B1|Baseline|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5260|NCT02467491|P1|Participant Flow|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5261|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5262|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5263|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5264|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5265|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5266|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5267|NCT02467491|E1|Reported Event|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
5268|NCT02465489|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive five treatments in different orders:~deferiprone ER tablets under fasting conditions~deferiprone ER tablets under fed conditions~deferiprone ER tablets administered as half-tablets under fed conditions~Ferriprox IR tablets under fasting conditions~Ferriprox IR tablets under fed conditions"
7223|NCT02414828|E1|Reported Event|Placebo|Sterile buffer, Intramuscular (IM)
5269|NCT02465489|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::~A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions~The sequences were as follows;~Sequence 1 (n=4): A-B-E-C-D~Sequence 2 (n=4): B-C-A-D-E~Sequence 3 (n=4): C-D-B-E-A~Sequence 4 (n=4): D-E-C-A-B~Sequence 5 (n=4): E-A-D-B-C"
5270|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5271|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5272|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5273|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5274|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5275|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5276|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5277|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5278|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5279|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5280|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5281|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5282|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5283|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5284|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5285|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5286|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5287|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5288|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5289|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5290|NCT02465489|E5|Reported Event|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5291|NCT02465489|E4|Reported Event|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
5292|NCT02465489|E3|Reported Event|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5589|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
9458|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
5293|NCT02465489|E2|Reported Event|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5294|NCT02465489|E1|Reported Event|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
5295|NCT02465073|B4|Baseline|Total|Total of all reporting groups
5296|NCT02465073|B3|Baseline|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
5297|NCT02465073|B2|Baseline|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
5298|NCT02465073|B1|Baseline|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
5299|NCT02465073|P3|Participant Flow|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
5300|NCT02465073|P2|Participant Flow|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
5301|NCT02465073|P1|Participant Flow|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
5302|NCT02465073|O3|Outcome|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
5303|NCT02465073|O2|Outcome|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
5304|NCT02465073|O1|Outcome|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
5305|NCT02465073|E3|Reported Event|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
5306|NCT02465073|E2|Reported Event|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
5307|NCT02465073|E1|Reported Event|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
5308|NCT02463331|B3|Baseline|Total|Total of all reporting groups
5309|NCT02463331|B2|Baseline|Azathioprine Plus Prednisone|"azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
5310|NCT02463331|B1|Baseline|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
5311|NCT02463331|P2|Participant Flow|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
5312|NCT02463331|P1|Participant Flow|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
5313|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
5314|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
5315|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
5316|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
5317|NCT02463331|E2|Reported Event|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
5318|NCT02463331|E1|Reported Event|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
5319|NCT02462291|B3|Baseline|Total|Total of all reporting groups
5320|NCT02462291|B2|Baseline|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5321|NCT02462291|B1|Baseline|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5322|NCT02462291|P2|Participant Flow|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5323|NCT02462291|P1|Participant Flow|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5324|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5590|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5325|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5326|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5327|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5328|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5329|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5330|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5331|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5332|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5333|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5334|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5335|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5336|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5337|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5338|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
5339|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5340|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5341|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5342|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
5343|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5344|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
5345|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5346|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
5347|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5348|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5349|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5350|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5351|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5352|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5493|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5353|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5354|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5355|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5356|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
5357|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5358|NCT02462291|E2|Reported Event|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
5359|NCT02462291|E1|Reported Event|Experimental Group (TR)|"A group of 82 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
5360|NCT02461992|B1|Baseline|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5361|NCT02461992|P1|Participant Flow|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5362|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5363|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5364|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5365|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5366|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5367|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5368|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5369|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5370|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5371|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5372|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5373|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5374|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5375|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5376|NCT02461992|E1|Reported Event|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
5377|NCT02461290|B1|Baseline|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5378|NCT02461290|P1|Participant Flow|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated follicular lymphoma (FL) received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included cyclophosphamide, vincristine, and prednisone (CVP); cyclophosphamide, doxorubin, vincristine, and predisone (CHOP); or fludarabine, cyclophosphamide, and mitoxantrone (FCM). Rituximab was administered as 375 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5494|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5591|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5379|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5380|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5381|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5382|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5383|NCT02461290|E1|Reported Event|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
5384|NCT02460458|B1|Baseline|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5385|NCT02460458|P1|Participant Flow|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5386|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5387|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5388|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5389|NCT02460458|E1|Reported Event|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
5390|NCT02458768|B3|Baseline|Total|Total of all reporting groups
5391|NCT02458768|B2|Baseline|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
5392|NCT02458768|B1|Baseline|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
5393|NCT02458768|P2|Participant Flow|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
5394|NCT02458768|P1|Participant Flow|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
5395|NCT02458768|O2|Outcome|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
5396|NCT02458768|O1|Outcome|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
5397|NCT02458768|E2|Reported Event|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
5398|NCT02458768|E1|Reported Event|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
5399|NCT02458365|B3|Baseline|Total|Total of all reporting groups
5400|NCT02458365|B2|Baseline|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5495|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5401|NCT02458365|B1|Baseline|Intevention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5402|NCT02458365|P2|Participant Flow|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5403|NCT02458365|P1|Participant Flow|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5404|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5405|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5406|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5407|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5408|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5409|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5410|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5411|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5412|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5413|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
9459|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
5414|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5415|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5416|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5417|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5418|NCT02458365|O2|Outcome|Comparison: Health in Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5419|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5420|NCT02458365|E2|Reported Event|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
5421|NCT02458365|E1|Reported Event|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
5422|NCT02457728|B1|Baseline|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair."
5423|NCT02457728|P1|Participant Flow|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair."
5424|NCT02457728|O1|Outcome|Single-port TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
5425|NCT02457728|E1|Reported Event|TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
5426|NCT02457247|B5|Baseline|Total|Total of all reporting groups
5427|NCT02457247|B4|Baseline|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
5428|NCT02457247|B3|Baseline|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
5429|NCT02457247|B2|Baseline|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
5430|NCT02457247|B1|Baseline|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
5431|NCT02457247|P4|Participant Flow|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
5432|NCT02457247|P3|Participant Flow|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
7972|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
5433|NCT02457247|P2|Participant Flow|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
5434|NCT02457247|P1|Participant Flow|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
5435|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5436|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5437|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5438|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5439|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5440|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5441|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5442|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5443|NCT02457247|O6|Outcome|Test Group 2: Total|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.
5444|NCT02457247|O5|Outcome|Test Group 1: Total|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.
5445|NCT02457247|O4|Outcome|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
5446|NCT02457247|O3|Outcome|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
5447|NCT02457247|O2|Outcome|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
5448|NCT02457247|O1|Outcome|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
5449|NCT02457247|E4|Reported Event|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5450|NCT02457247|E3|Reported Event|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
5451|NCT02457247|E2|Reported Event|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5452|NCT02457247|E1|Reported Event|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
5453|NCT02455050|B5|Baseline|Total|Total of all reporting groups
5454|NCT02455050|B4|Baseline|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5455|NCT02455050|B3|Baseline|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5456|NCT02455050|B2|Baseline|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5457|NCT02455050|B1|Baseline|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5458|NCT02455050|P4|Participant Flow|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5459|NCT02455050|P3|Participant Flow|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5496|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5460|NCT02455050|P2|Participant Flow|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5461|NCT02455050|P1|Participant Flow|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5462|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5463|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5464|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5465|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5466|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5467|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5468|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5469|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5470|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5471|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5472|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5473|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5474|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5475|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5476|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5477|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5478|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5479|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5480|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5481|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5482|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5483|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5484|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5485|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5486|NCT02455050|O1|Outcome|New Eye Drop Formulation and Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5487|NCT02455050|O1|Outcome|New Eye Drop Formulation and Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5488|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5489|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5490|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5491|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5492|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5592|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5499|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5500|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5501|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5502|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5503|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5504|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5505|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5506|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5507|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5508|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5509|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
5510|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5511|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5512|NCT02455050|O4|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5513|NCT02455050|O3|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5514|NCT02455050|O2|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5515|NCT02455050|O1|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5516|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
5517|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
5518|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
5519|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
5520|NCT02455050|E4|Reported Event|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5521|NCT02455050|E3|Reported Event|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5522|NCT02455050|E2|Reported Event|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5523|NCT02455050|E1|Reported Event|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
5524|NCT02454608|B3|Baseline|Total|Total of all reporting groups
5525|NCT02454608|B2|Baseline|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5526|NCT02454608|B1|Baseline|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5527|NCT02454608|P2|Participant Flow|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5593|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5594|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5595|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5528|NCT02454608|P1|Participant Flow|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5529|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5530|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5531|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5532|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5533|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5534|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5535|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5536|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5537|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5538|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5539|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5540|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5541|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5596|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5597|NCT02454127|E4|Reported Event|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5598|NCT02454127|E3|Reported Event|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
9460|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
5542|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5543|NCT02454608|E2|Reported Event|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
5544|NCT02454608|E1|Reported Event|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
5545|NCT02454283|B3|Baseline|Total|Total of all reporting groups
5546|NCT02454283|B2|Baseline|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
5547|NCT02454283|B1|Baseline|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
5548|NCT02454283|P2|Participant Flow|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
5549|NCT02454283|P1|Participant Flow|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
5550|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
5551|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
5552|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
5553|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
5554|NCT02454283|E2|Reported Event|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
5555|NCT02454283|E1|Reported Event|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
5556|NCT02454127|B5|Baseline|Total|Total of all reporting groups
5557|NCT02454127|B4|Baseline|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5558|NCT02454127|B3|Baseline|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5559|NCT02454127|B2|Baseline|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5560|NCT02454127|B1|Baseline|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5561|NCT02454127|P4|Participant Flow|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5562|NCT02454127|P3|Participant Flow|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5563|NCT02454127|P2|Participant Flow|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5564|NCT02454127|P1|Participant Flow|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5565|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5566|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5567|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5568|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5569|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5570|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5571|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5572|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5573|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5574|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5575|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5576|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5577|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5578|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5579|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5580|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5581|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
5582|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
5583|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
5584|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
5585|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
9461|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
5605|NCT02454101|P1|Participant Flow|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5606|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5607|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5608|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5609|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5610|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5611|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5612|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5613|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5614|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5615|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5616|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5617|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5618|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5619|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5620|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5621|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5622|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5623|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5624|NCT02454101|E2|Reported Event|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
5625|NCT02454101|E1|Reported Event|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
5626|NCT02453581|B1|Baseline|Randomised Participants|Twenty-four male and female subjects were enrolled in the study.
5627|NCT02453581|P3|Participant Flow|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
5628|NCT02453581|P2|Participant Flow|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
5629|NCT02453581|P1|Participant Flow|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
5630|NCT02453581|O1|Outcome|OZ439 500mg Arm|Cohort 3 - OZ439 500mg
5631|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
5632|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
5633|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
5634|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
5635|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
5636|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
5637|NCT02453581|O8|Outcome|OZ439 500mg - R024|Cohort 3 - OZ439 500mg - Subject R024
5638|NCT02453581|O7|Outcome|OZ439 500mg - R023|Cohort 3 - OZ439 500mg - Subject R023
5639|NCT02453581|O6|Outcome|OZ439 500mg - R022|Cohort 3 - OZ439 500mg - Subject R022
5640|NCT02453581|O5|Outcome|OZ439 500mg - R021|Cohort 3 - OZ439 500mg - Subject R021
5641|NCT02453581|O4|Outcome|OZ439 500mg - R020|Cohort 3 - OZ439 500mg - Subject R020
5642|NCT02453581|O3|Outcome|OZ439 500mg - R019|Cohort 3 - OZ439 500mg - Subject R019
5643|NCT02453581|O2|Outcome|OZ439 500mg - R018|Cohort 3 - OZ439 500mg - Subject R018
5644|NCT02453581|O1|Outcome|OZ439 500mg - R017|Cohort 3 - OZ439 500mg - Subject R017
5645|NCT02453581|E3|Reported Event|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
5646|NCT02453581|E2|Reported Event|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
5647|NCT02453581|E1|Reported Event|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
5648|NCT02452944|B3|Baseline|Total|Total of all reporting groups
5649|NCT02452944|B2|Baseline|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
5650|NCT02452944|B1|Baseline|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
5651|NCT02452944|P2|Participant Flow|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)~The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected."
5652|NCT02452944|P1|Participant Flow|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
5653|NCT02452944|O2|Outcome|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
5654|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
5655|NCT02452944|O2|Outcome|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided m"
5656|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv"
5657|NCT02452944|E2|Reported Event|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
5658|NCT02452944|E1|Reported Event|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
5659|NCT02451150|B3|Baseline|Total|Total of all reporting groups
5660|NCT02451150|B2|Baseline|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5661|NCT02451150|B1|Baseline|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5662|NCT02451150|P2|Participant Flow|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5678|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5679|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5680|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5681|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5682|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5683|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5684|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5685|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5686|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5687|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5688|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5689|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5690|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5691|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5692|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5693|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5694|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5695|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5696|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5697|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5698|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5699|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5700|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5701|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5702|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5703|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5704|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5705|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5706|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5707|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5708|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5709|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5710|NCT02451150|E2|Reported Event|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
5711|NCT02451150|E1|Reported Event|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
5712|NCT02450799|B4|Baseline|Total|Total of all reporting groups
5713|NCT02450799|B3|Baseline|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
5714|NCT02450799|B2|Baseline|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
5715|NCT02450799|B1|Baseline|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
5716|NCT02450799|P3|Participant Flow|PMMA|Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
5717|NCT02450799|P2|Participant Flow|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
5718|NCT02450799|P1|Participant Flow|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
5719|NCT02450799|O3|Outcome|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
5720|NCT02450799|O2|Outcome|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
5721|NCT02450799|O1|Outcome|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
5722|NCT02450799|E6|Reported Event|PMMA (Prospective)|Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
5723|NCT02450799|E5|Reported Event|Silicone (Prospective)|Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
5724|NCT02450799|E4|Reported Event|AcrySof (Prospective)|Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
5725|NCT02450799|E3|Reported Event|PMMA (Retrospective)|Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
5726|NCT02450799|E2|Reported Event|Silicone (Retrospective)|Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
5727|NCT02450799|E1|Reported Event|AcrySof (Retrospective)|Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
5728|NCT02450747|B1|Baseline|Multi-focal(Etafilcon A)|All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
5729|NCT02450747|P1|Participant Flow|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
5730|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
5731|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
5732|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
5733|NCT02450747|O1|Outcome|Basline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
5734|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
5735|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
5736|NCT02450747|E1|Reported Event|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
5737|NCT02449902|B3|Baseline|Total|Total of all reporting groups
5738|NCT02449902|B2|Baseline|Placebo Daily for 14 Days|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
5739|NCT02449902|B1|Baseline|Estradiol 10 μg Daily for 14 Days|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
5740|NCT02449902|P2|Participant Flow|Placebo|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
5741|NCT02449902|P1|Participant Flow|TX-12-004-HR 10μg|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
5742|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5743|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5744|NCT02449902|O2|Outcome|Treatment 2|"Placebo vaginal softgel capsule~placebo: 1 placebo capsule inserted vaginally for 14 days."
5745|NCT02449902|O1|Outcome|Treatment 1|"Estradiol 10 μg vaginal softgel capsule~Estradiol: 1 10 µg capsule inserted vaginally for 14 days."
5746|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5747|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5748|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5749|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5750|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5751|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5752|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5753|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5754|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5755|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5756|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5757|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5758|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5759|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5760|NCT02449902|O2|Outcome|Placebo|Control treatment group.
5761|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
5762|NCT02449902|E2|Reported Event|Placebo|Control treatment group.
5763|NCT02449902|E1|Reported Event|TX-12-004-HR|Active treatment group.
5764|NCT02449044|B1|Baseline|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5765|NCT02449044|P1|Participant Flow|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5766|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5767|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5768|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5769|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5770|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5771|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5772|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5773|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5774|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5775|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5776|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5777|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5778|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5779|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5780|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5781|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5782|NCT02449044|E1|Reported Event|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
5783|NCT02448914|B1|Baseline|TRIGEL and Duodopa in Randomized Order|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5784|NCT02448914|P2|Participant Flow|Duodopa First, Then TRIGEL|"First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5785|NCT02448914|P1|Participant Flow|TRIGEL First, Then Duodopa|"First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5786|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5787|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5788|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5801|NCT02448862|B2|Baseline|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5789|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5790|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5791|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5792|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5793|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5794|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5795|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5796|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5797|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5798|NCT02448914|E2|Reported Event|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
5799|NCT02448914|E1|Reported Event|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
5800|NCT02448862|B3|Baseline|Total|Total of all reporting groups
9462|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
5802|NCT02448862|B1|Baseline|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5803|NCT02448862|P2|Participant Flow|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5804|NCT02448862|P1|Participant Flow|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5805|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5806|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5807|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5808|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5809|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5810|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5811|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5842|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
9463|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
5812|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5813|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5814|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5815|NCT02448862|E2|Reported Event|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5816|NCT02448862|E1|Reported Event|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
5817|NCT02447458|B7|Baseline|Total|Total of all reporting groups
5818|NCT02447458|B6|Baseline|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5819|NCT02447458|B5|Baseline|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5820|NCT02447458|B4|Baseline|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5821|NCT02447458|B3|Baseline|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5822|NCT02447458|B2|Baseline|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5823|NCT02447458|B1|Baseline|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5824|NCT02447458|P6|Participant Flow|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5825|NCT02447458|P5|Participant Flow|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5826|NCT02447458|P4|Participant Flow|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5827|NCT02447458|P3|Participant Flow|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5828|NCT02447458|P2|Participant Flow|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5829|NCT02447458|P1|Participant Flow|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5830|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5831|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5832|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5833|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5834|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5835|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5836|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5837|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5838|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5839|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5840|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5841|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5843|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5845|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5846|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5847|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5848|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5849|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5850|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5851|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5852|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5853|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5854|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5855|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5856|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5857|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5858|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5859|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5860|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5861|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5862|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5863|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5864|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5865|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5866|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5867|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5868|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5869|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5870|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5871|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5872|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5873|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5874|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5875|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5876|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5877|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5878|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5879|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5880|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5881|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5882|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5883|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5884|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5885|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5886|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5887|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5888|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5889|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5890|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5891|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5892|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5893|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5894|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5895|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5896|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5897|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5898|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5899|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5900|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5901|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5902|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5903|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5904|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5905|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5906|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5907|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5908|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5909|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5910|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5911|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5912|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5913|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5914|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5915|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5916|NCT02447458|E8|Reported Event|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5917|NCT02447458|E7|Reported Event|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5918|NCT02447458|E6|Reported Event|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
5919|NCT02447458|E5|Reported Event|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
5920|NCT02447458|E4|Reported Event|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
5921|NCT02447458|E3|Reported Event|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
5922|NCT02447458|E2|Reported Event|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
5923|NCT02447458|E1|Reported Event|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
5924|NCT02447133|B1|Baseline|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
5925|NCT02447133|P1|Participant Flow|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
5926|NCT02447133|O3|Outcome|6x6 Disc Scan|TopQ of 6x6 Disc Scan
5927|NCT02447133|O2|Outcome|6x6 Macula Scan|TopQ of 6x6 Macular Scan
5928|NCT02447133|O1|Outcome|12x9 Wide Scan|TopQ of 12x9 Wide Scan
5929|NCT02447133|E1|Reported Event|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
5930|NCT02446990|B3|Baseline|Total|Total of all reporting groups
5931|NCT02446990|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5932|NCT02446990|B1|Baseline|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5933|NCT02446990|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5934|NCT02446990|P1|Participant Flow|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5935|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5936|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5937|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5938|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5939|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5940|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5941|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5942|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5943|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5944|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5945|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5946|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5947|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5948|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5949|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5950|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5951|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5952|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5953|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5954|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5955|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5956|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5957|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5958|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5959|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5960|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5961|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5962|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5963|NCT02446990|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5964|NCT02446990|E1|Reported Event|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
5965|NCT02446171|B5|Baseline|Total|Total of all reporting groups
5966|NCT02446171|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
5967|NCT02446171|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
5968|NCT02446171|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
5969|NCT02446171|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
5970|NCT02446171|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
5971|NCT02446171|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
5972|NCT02446171|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
5973|NCT02446171|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
5974|NCT02446171|O2|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5975|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5976|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5977|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
9464|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
5978|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5979|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5980|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5981|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5982|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5983|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5984|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5985|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5986|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5987|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5988|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5989|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5990|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5991|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5992|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5993|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5994|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5995|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
5996|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
5997|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
5998|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
5999|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6000|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6001|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6002|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6003|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6004|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6005|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6006|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6007|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6008|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6009|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6010|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6011|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6012|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6013|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6014|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6015|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6016|NCT02446171|O1|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6017|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6018|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6019|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6020|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6021|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6022|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6023|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6024|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6025|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6026|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6027|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6028|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6029|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6030|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6031|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6032|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6033|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
9465|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
6035|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6036|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6037|NCT02446171|E4|Reported Event|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
6038|NCT02446171|E3|Reported Event|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
6039|NCT02446171|E2|Reported Event|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
6040|NCT02446171|E1|Reported Event|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
6041|NCT02445755|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
6042|NCT02445755|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
6043|NCT02445755|O4|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
6044|NCT02445755|O3|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
6045|NCT02445755|O2|Outcome|BiliCare TcB With Infection Control Tip|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.
6046|NCT02445755|O1|Outcome|BiliCare TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
6047|NCT02445755|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
6048|NCT02445573|B3|Baseline|Total|Total of all reporting groups
6049|NCT02445573|B2|Baseline|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6050|NCT02445573|B1|Baseline|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6051|NCT02445573|P2|Participant Flow|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6052|NCT02445573|P1|Participant Flow|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6053|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6054|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6055|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6232|NCT02440659|P1|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
6056|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6057|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6058|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6059|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6060|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6061|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6062|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6063|NCT02445573|E2|Reported Event|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
6064|NCT02445573|E1|Reported Event|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
6065|NCT02445287|B3|Baseline|Total|Total of all reporting groups
6066|NCT02445287|B2|Baseline|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
6067|NCT02445287|B1|Baseline|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
6068|NCT02445287|P2|Participant Flow|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
6107|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6234|NCT02440659|O1|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
6069|NCT02445287|P1|Participant Flow|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
6070|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - SND|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6071|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6072|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - FDK|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6073|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6074|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - High Res|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6075|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6076|NCT02445287|O2|Outcome|Investigational - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6108|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6109|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6110|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
9466|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
6077|NCT02445287|O1|Outcome|Predicate - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
6078|NCT02445287|E3|Reported Event|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
6079|NCT02445287|E2|Reported Event|Reference & Invest. - Cadavers 3D|Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
6080|NCT02445287|E1|Reported Event|Predicate & Invest.- Cadavers 2D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph.
6081|NCT02444715|B3|Baseline|Total|Total of all reporting groups
6082|NCT02444715|B2|Baseline|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6083|NCT02444715|B1|Baseline|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6084|NCT02444715|P2|Participant Flow|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6085|NCT02444715|P1|Participant Flow|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6086|NCT02444715|O1|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6087|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6088|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6089|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6090|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6091|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6092|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6093|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6094|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6095|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6096|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6097|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6098|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6099|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6100|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6101|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6102|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6103|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6104|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6105|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6106|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6111|NCT02444715|E2|Reported Event|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
6112|NCT02444715|E1|Reported Event|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
6113|NCT02444182|B3|Baseline|Total|Total of all reporting groups
6114|NCT02444182|B2|Baseline|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
6115|NCT02444182|B1|Baseline|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
6116|NCT02444182|P2|Participant Flow|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
6117|NCT02444182|P1|Participant Flow|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
6118|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
6119|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
6120|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
6121|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
6122|NCT02444182|E2|Reported Event|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
6123|NCT02444182|E1|Reported Event|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
6124|NCT02443792|B3|Baseline|Total|Total of all reporting groups
6125|NCT02443792|B2|Baseline|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6126|NCT02443792|B1|Baseline|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6127|NCT02443792|P2|Participant Flow|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6128|NCT02443792|P1|Participant Flow|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6129|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6130|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6131|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6132|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6133|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6134|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6135|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6136|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6137|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6138|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6139|NCT02443792|E2|Reported Event|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
6140|NCT02443792|E1|Reported Event|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
6141|NCT02442700|B3|Baseline|Total|Total of all reporting groups
6142|NCT02442700|B2|Baseline|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
6143|NCT02442700|B1|Baseline|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
6144|NCT02442700|P2|Participant Flow|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
6145|NCT02442700|P1|Participant Flow|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
6146|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
6147|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
6148|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
6149|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
6150|NCT02442700|E2|Reported Event|Treatment B|Treatment B = administration placebo for 12 weeks
6151|NCT02442700|E1|Reported Event|Treatment A|Treatment A = administration pitavastatin for 12 weeks
6152|NCT02442310|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
6153|NCT02442310|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
6154|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
6155|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6156|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6157|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6158|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
6159|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6160|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6161|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6162|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
6163|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6164|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6165|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6166|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
6167|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6168|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6169|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6170|NCT02442310|E4|Reported Event|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
6171|NCT02442310|E3|Reported Event|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6233|NCT02440659|O2|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
6172|NCT02442310|E2|Reported Event|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6173|NCT02442310|E1|Reported Event|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
6174|NCT02441218|B3|Baseline|Total|Total of all reporting groups
6175|NCT02441218|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6176|NCT02441218|B1|Baseline|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6177|NCT02441218|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6178|NCT02441218|P1|Participant Flow|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6179|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6180|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6181|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6182|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6183|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6184|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6185|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6186|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6187|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6188|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6189|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6190|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6191|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6192|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6193|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6194|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6195|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6196|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6197|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6198|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6199|NCT02441218|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6200|NCT02441218|E1|Reported Event|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
6201|NCT02441179|B3|Baseline|Total|Total of all reporting groups
6202|NCT02441179|B2|Baseline|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6226|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
6227|NCT02441114|E1|Reported Event|HCP0910 and HGP1011|"Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)~HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"
6203|NCT02441179|B1|Baseline|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6204|NCT02441179|P2|Participant Flow|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6205|NCT02441179|P1|Participant Flow|Acute Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6206|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6207|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6208|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6209|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6210|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6211|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6212|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6228|NCT02440659|B3|Baseline|Total|Total of all reporting groups
6229|NCT02440659|B2|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
6230|NCT02440659|B1|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
6231|NCT02440659|P2|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
9467|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
6213|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6214|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6215|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6216|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6217|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6218|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6219|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6220|NCT02441179|E2|Reported Event|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
6221|NCT02441179|E1|Reported Event|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
6222|NCT02441114|B1|Baseline|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
6223|NCT02441114|P1|Participant Flow|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
6224|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
6225|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
7973|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
6235|NCT02440659|E2|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
6236|NCT02440659|E1|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
6237|NCT02440633|B1|Baseline|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
6238|NCT02440633|P1|Participant Flow|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
6239|NCT02440633|O1|Outcome|Plasma|
6240|NCT02440633|O2|Outcome|Whole Blood|
6241|NCT02440633|O1|Outcome|Plasma|
6242|NCT02440633|O3|Outcome|Total|
6243|NCT02440633|O2|Outcome|Urine|
6244|NCT02440633|O1|Outcome|Feces|
6245|NCT02440633|E1|Reported Event|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
6246|NCT02439879|B3|Baseline|Total|Total of all reporting groups
6247|NCT02439879|B2|Baseline|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
6248|NCT02439879|B1|Baseline|Alpha Lipoic Acid Treatment|"After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid~Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks."
6249|NCT02439879|P2|Participant Flow|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
6250|NCT02439879|P1|Participant Flow|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
6251|NCT02439879|O2|Outcome|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
6252|NCT02439879|O1|Outcome|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
6253|NCT02439879|E2|Reported Event|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
6254|NCT02439879|E1|Reported Event|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
6255|NCT02439138|B1|Baseline|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6256|NCT02439138|P1|Participant Flow|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6257|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6258|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6259|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6260|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6261|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6262|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6263|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
9468|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
6264|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6265|NCT02439138|E1|Reported Event|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
6266|NCT02438540|B3|Baseline|Total|Total of all reporting groups
6267|NCT02438540|B2|Baseline|Metformin & Placebo|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.~metformin Placebo (for acupuncture including electro"
6268|NCT02438540|B1|Baseline|Metformin & Acupuncture|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6269|NCT02438540|P2|Participant Flow|Metformin & Placebo|Metformin 500 mg (one/two/three times per day) to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks.
6270|NCT02438540|P1|Participant Flow|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6271|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6272|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6273|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6274|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6275|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6276|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6277|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6278|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6279|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6369|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6280|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6281|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6282|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6283|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6284|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6285|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6286|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6287|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6288|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6289|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6290|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6291|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6292|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6293|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6294|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6295|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6524|NCT02432040|B2|Baseline|Placebo|Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6296|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6297|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6298|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6299|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6300|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6301|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6302|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6303|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo EA and auricular acupuncture"
6304|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6305|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6306|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6307|NCT02438540|E2|Reported Event|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
6308|NCT02438540|E1|Reported Event|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
6309|NCT02437409|B1|Baseline|All Patients|Treated with pREset Thrombectomy Retriever
6310|NCT02437409|P1|Participant Flow|All Patients|Treated with pREset Thrombectomy Retriever
6311|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
6312|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
6313|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
6314|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
6315|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
6316|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
6317|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
6318|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
6319|NCT02437409|E1|Reported Event|All Patients|Treated with pREset Thrombectomy Retriever
6320|NCT02437305|B3|Baseline|Total|Total of all reporting groups
6321|NCT02437305|B2|Baseline|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
9469|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
6322|NCT02437305|B1|Baseline|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
6323|NCT02437305|P2|Participant Flow|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
6324|NCT02437305|P1|Participant Flow|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
6325|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
6326|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
6327|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
6328|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
6329|NCT02437305|E2|Reported Event|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
6330|NCT02437305|E1|Reported Event|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
6331|NCT02436811|B4|Baseline|Total|Total of all reporting groups
6332|NCT02436811|B3|Baseline|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
6333|NCT02436811|B2|Baseline|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
6334|NCT02436811|B1|Baseline|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
6335|NCT02436811|P3|Participant Flow|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
6336|NCT02436811|P2|Participant Flow|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
6337|NCT02436811|P1|Participant Flow|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
6338|NCT02436811|O3|Outcome|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
6339|NCT02436811|O2|Outcome|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
6368|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6340|NCT02436811|O1|Outcome|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
6341|NCT02436811|E3|Reported Event|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
6342|NCT02436811|E2|Reported Event|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
6343|NCT02436811|E1|Reported Event|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
6344|NCT02436577|B7|Baseline|Total|Total of all reporting groups
6345|NCT02436577|B6|Baseline|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6346|NCT02436577|B5|Baseline|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6347|NCT02436577|B4|Baseline|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6348|NCT02436577|B3|Baseline|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6349|NCT02436577|B2|Baseline|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6350|NCT02436577|B1|Baseline|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6351|NCT02436577|P6|Participant Flow|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6352|NCT02436577|P5|Participant Flow|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6353|NCT02436577|P4|Participant Flow|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6354|NCT02436577|P3|Participant Flow|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6355|NCT02436577|P2|Participant Flow|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6356|NCT02436577|P1|Participant Flow|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
6357|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6358|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6359|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6360|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6361|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6362|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6363|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6364|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6365|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6366|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6367|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
9470|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
6370|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6371|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6372|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6373|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6374|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6375|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6376|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6377|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6378|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6379|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6380|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6381|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6382|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6383|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6384|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6385|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6386|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6387|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6388|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6389|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6390|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6391|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6392|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6393|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6394|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6395|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6396|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6397|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6398|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6399|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6400|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6401|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6402|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6403|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6404|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6405|NCT02436577|E3|Reported Event|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
6406|NCT02436577|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
6407|NCT02436577|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
6408|NCT02436330|B3|Baseline|Total|Total of all reporting groups
6409|NCT02436330|B2|Baseline|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
6410|NCT02436330|B1|Baseline|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
6411|NCT02436330|P2|Participant Flow|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.~n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013"
6412|NCT02436330|P1|Participant Flow|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.~n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013."
6413|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
6414|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
6415|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
6416|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
6417|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
6418|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6419|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6420|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6421|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6422|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6423|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6424|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6425|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6426|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6427|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6428|NCT02436330|O2|Outcome|Didactic Health Teaching|Subjects only receiving classroom structured nutrition/health education.
6429|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
6525|NCT02432040|B1|Baseline|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6430|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
6431|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
6432|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6433|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6434|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
6435|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
6436|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6437|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6438|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6439|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6440|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6441|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6442|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6443|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6444|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6445|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6446|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6447|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6448|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
6449|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
6450|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
6451|NCT02436330|E2|Reported Event|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
6452|NCT02436330|E1|Reported Event|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
6453|NCT02435966|B4|Baseline|Total|Total of all reporting groups
6454|NCT02435966|B3|Baseline|Untreated Control|Natural history of the condition
6455|NCT02435966|B2|Baseline|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6526|NCT02432040|P2|Participant Flow|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
9471|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
6456|NCT02435966|B1|Baseline|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6457|NCT02435966|P3|Participant Flow|Untreated Control|Natural history of the condition
6458|NCT02435966|P2|Participant Flow|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6459|NCT02435966|P1|Participant Flow|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6460|NCT02435966|O3|Outcome|Untreated Control|Natural history of the condition
6461|NCT02435966|O2|Outcome|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6462|NCT02435966|O1|Outcome|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6463|NCT02435966|E3|Reported Event|Untreated Control|Natural history of the condition
6464|NCT02435966|E2|Reported Event|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6465|NCT02435966|E1|Reported Event|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
6466|NCT02435836|B1|Baseline|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6467|NCT02435836|P1|Participant Flow|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6468|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6469|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6470|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6471|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6472|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6473|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6474|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6475|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6476|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6528|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6477|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6478|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6479|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6480|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6481|NCT02435836|E1|Reported Event|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
6482|NCT02434939|B3|Baseline|Total|Total of all reporting groups
6483|NCT02434939|B2|Baseline|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6484|NCT02434939|B1|Baseline|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6485|NCT02434939|P2|Participant Flow|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6486|NCT02434939|P1|Participant Flow|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6487|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6488|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6489|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes . Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6490|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6491|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6492|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6493|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6494|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6527|NCT02432040|P1|Participant Flow|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6495|NCT02434939|E2|Reported Event|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6496|NCT02434939|E1|Reported Event|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
6497|NCT02434523|B3|Baseline|Total|Total of all reporting groups
6498|NCT02434523|B2|Baseline|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6499|NCT02434523|B1|Baseline|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6500|NCT02434523|P2|Participant Flow|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6501|NCT02434523|P1|Participant Flow|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6502|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6503|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6504|NCT02434523|O2|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Placebo pill"
6505|NCT02434523|O1|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)~Amitriptyline"
6506|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6507|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6508|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6509|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6510|NCT02434523|E2|Reported Event|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6511|NCT02434523|E1|Reported Event|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
6512|NCT02433366|B3|Baseline|Total|Total of all reporting groups
6513|NCT02433366|B2|Baseline|Patients|AF patients on treatment with Pradaxa®.
6514|NCT02433366|B1|Baseline|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
6515|NCT02433366|P2|Participant Flow|Patients|AF patients on treatment with Pradaxa®.
6516|NCT02433366|P1|Participant Flow|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
6517|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
6518|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
6519|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
6520|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
6521|NCT02433366|E2|Reported Event|Patients|AF patients on treatment with Pradaxa®.
6522|NCT02433366|E1|Reported Event|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
6523|NCT02432040|B3|Baseline|Total|Total of all reporting groups
7156|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
6529|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6530|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6531|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6532|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6533|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6534|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6535|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6536|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6537|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6538|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6539|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6540|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6541|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6542|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6543|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6544|NCT02432040|E2|Reported Event|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
6545|NCT02432040|E1|Reported Event|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
6546|NCT02431741|B1|Baseline|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
6547|NCT02431741|P1|Participant Flow|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
6548|NCT02431741|O1|Outcome|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
6549|NCT02431741|E1|Reported Event|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
6550|NCT02431455|B3|Baseline|Total|Total of all reporting groups
6551|NCT02431455|B2|Baseline|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6552|NCT02431455|B1|Baseline|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6553|NCT02431455|P2|Participant Flow|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6554|NCT02431455|P1|Participant Flow|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6555|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6556|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6557|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6558|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6559|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6560|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6561|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6562|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
7157|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
6563|NCT02431455|E2|Reported Event|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
6564|NCT02431455|E1|Reported Event|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
6565|NCT02431299|B3|Baseline|Total|Total of all reporting groups
6566|NCT02431299|B2|Baseline|IMR Clinicians|Clinicians who provided the IMR intervention to the IMR Consumers
6567|NCT02431299|B1|Baseline|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6568|NCT02431299|P2|Participant Flow|IMR Clinicians|The clinicians who provided IMR intervention to the IMR Consumers
6569|NCT02431299|P1|Participant Flow|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6570|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6571|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6572|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6573|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6574|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6575|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6576|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6577|NCT02431299|O1|Outcome|IMR Clinicians|Clinicians providing IMR to the IMR consumers.
6578|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6579|NCT02431299|E2|Reported Event|IMR Clinicians|Clinician participants who are providing Illness Management and Recovery (IMR) intervention.
6580|NCT02431299|E1|Reported Event|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
6581|NCT02430870|B9|Baseline|Total|Total of all reporting groups
6582|NCT02430870|B8|Baseline|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6583|NCT02430870|B7|Baseline|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6584|NCT02430870|B6|Baseline|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6585|NCT02430870|B5|Baseline|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6586|NCT02430870|B4|Baseline|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6587|NCT02430870|B3|Baseline|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6588|NCT02430870|B2|Baseline|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6589|NCT02430870|B1|Baseline|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6590|NCT02430870|P8|Participant Flow|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6591|NCT02430870|P7|Participant Flow|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6592|NCT02430870|P6|Participant Flow|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6593|NCT02430870|P5|Participant Flow|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6594|NCT02430870|P4|Participant Flow|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6595|NCT02430870|P3|Participant Flow|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
7219|NCT02414828|O1|Outcome|Placebo|Sterile Buffer, Intramuscular (IM)
6596|NCT02430870|P2|Participant Flow|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6597|NCT02430870|P1|Participant Flow|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6598|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6599|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6600|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6601|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6602|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6603|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6604|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6605|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6606|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6607|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6608|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6609|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6610|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6611|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6612|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6613|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6614|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6615|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6616|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6617|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6618|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6619|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6620|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6621|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6622|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6623|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6624|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6625|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6626|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6627|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6628|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6629|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6630|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6631|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6632|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6633|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6634|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6635|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6636|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6637|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6638|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6639|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6640|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6641|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
9472|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
6642|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6643|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6644|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6645|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6646|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6647|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6648|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6649|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6650|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6651|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6652|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6653|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6654|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6655|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6656|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6657|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6658|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6659|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6660|NCT02430870|E8|Reported Event|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6661|NCT02430870|E7|Reported Event|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6662|NCT02430870|E6|Reported Event|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6663|NCT02430870|E5|Reported Event|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6664|NCT02430870|E4|Reported Event|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
6665|NCT02430870|E3|Reported Event|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6666|NCT02430870|E2|Reported Event|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6667|NCT02430870|E1|Reported Event|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
6668|NCT02430389|B3|Baseline|Total|Total of all reporting groups
6669|NCT02430389|B2|Baseline|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
6670|NCT02430389|B1|Baseline|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
6671|NCT02430389|P2|Participant Flow|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
6672|NCT02430389|P1|Participant Flow|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
6673|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Normal Saline: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
6674|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
6675|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
6676|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
6677|NCT02430389|E2|Reported Event|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
6678|NCT02430389|E1|Reported Event|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
6679|NCT02430090|B4|Baseline|Total|Total of all reporting groups
6680|NCT02430090|B3|Baseline|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6681|NCT02430090|B2|Baseline|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6682|NCT02430090|B1|Baseline|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6701|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
7220|NCT02414828|E4|Reported Event|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
6683|NCT02430090|P3|Participant Flow|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6684|NCT02430090|P2|Participant Flow|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6685|NCT02430090|P1|Participant Flow|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6686|NCT02430090|O3|Outcome|Levobupivacaine + Sufentanil|2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
6687|NCT02430090|O2|Outcome|Levobupivacaine + Fentanyl|2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
6688|NCT02430090|O1|Outcome|Levobupivacaine|2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
6689|NCT02430090|E3|Reported Event|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6690|NCT02430090|E2|Reported Event|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6691|NCT02430090|E1|Reported Event|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
6692|NCT02428413|B3|Baseline|Total|Total of all reporting groups
6693|NCT02428413|B2|Baseline|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6694|NCT02428413|B1|Baseline|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6695|NCT02428413|P2|Participant Flow|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6696|NCT02428413|P1|Participant Flow|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6697|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6698|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6699|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6700|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6702|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6703|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6704|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6705|NCT02428413|E2|Reported Event|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
6706|NCT02428413|E1|Reported Event|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
6707|NCT02427984|B4|Baseline|Total|Total of all reporting groups
6708|NCT02427984|B3|Baseline|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
6709|NCT02427984|B2|Baseline|Controls|All the patients of our Division for primary THA
6710|NCT02427984|B1|Baseline|Metal on Metal (MoM)|All the patients of our Division with MoM THA
6711|NCT02427984|P3|Participant Flow|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
6712|NCT02427984|P2|Participant Flow|Controls|
6713|NCT02427984|P1|Participant Flow|Metal on Metal (MoM)|All the patients of our Division with MoM THA
6714|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
6715|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
6716|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
6717|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
6718|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
6719|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
6720|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
6721|NCT02427984|O2|Outcome|Control|
6722|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
6723|NCT02427984|E3|Reported Event|Controls|
6724|NCT02427984|E2|Reported Event|Ceramic on Ceramic (CoC)|
6725|NCT02427984|E1|Reported Event|Metal on Metal (MoM)|
6726|NCT02427750|B3|Baseline|Total|Total of all reporting groups
6727|NCT02427750|B2|Baseline|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6728|NCT02427750|B1|Baseline|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6729|NCT02427750|P2|Participant Flow|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6730|NCT02427750|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6731|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6732|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6733|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6734|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6735|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6736|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6737|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6738|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6739|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6740|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6741|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6742|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6743|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6744|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6745|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6746|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6747|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
6748|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6749|NCT02427750|E3|Reported Event|Total|
6750|NCT02427750|E2|Reported Event|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6751|NCT02427750|E1|Reported Event|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
6752|NCT02427477|B3|Baseline|Total|Total of all reporting groups
6753|NCT02427477|B2|Baseline|Delefilcon A / Senofilcon A / Delefilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
6754|NCT02427477|B1|Baseline|Senofilcon A / Delefilcon A / Senofilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
6755|NCT02427477|P2|Participant Flow|Delefilcon A / Senofilcon A / Delefilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
6756|NCT02427477|P1|Participant Flow|Senofilcon A / Delefilcon A/ Senofilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
6757|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
6758|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
6759|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
6760|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
6761|NCT02427477|E2|Reported Event|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
6762|NCT02427477|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
6763|NCT02424565|B1|Baseline|Overall Participants|Total number of participants randomized and treated in the study.
6764|NCT02424565|P2|Participant Flow|First Placebo Balm Then Test Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
6765|NCT02424565|P1|Participant Flow|First Test Balm Then Placebo Balm|2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
6766|NCT02424565|O2|Outcome|Placebo Balm|2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
6767|NCT02424565|O1|Outcome|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
6768|NCT02424565|E2|Reported Event|Placebo Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
6769|NCT02424565|E1|Reported Event|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
6770|NCT02424149|B3|Baseline|Total|Total of all reporting groups
6771|NCT02424149|B2|Baseline|Phenazopyridine|Preoperative phenazopyridine
6772|NCT02424149|B1|Baseline|Control|No preoperative phenazopyridine
6773|NCT02424149|P2|Participant Flow|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6774|NCT02424149|P1|Participant Flow|Control|No preoperative phenazopyridine
6775|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6776|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
6777|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6778|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
6779|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6780|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
6781|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6782|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
6783|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
6784|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
6785|NCT02424149|E2|Reported Event|Phenazopyridine|Preoperative phenazopyridine
6786|NCT02424149|E1|Reported Event|Control|No preoperative phenazopyridine
6787|NCT02423993|B5|Baseline|Total|Total of all reporting groups
6855|NCT02423317|B2|Baseline|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
7153|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasted SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
6788|NCT02423993|B4|Baseline|CSII + Standart Education|Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
6789|NCT02423993|B3|Baseline|CSII + Group Education|"Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
6790|NCT02423993|B2|Baseline|SAP + Standart Education|Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
6791|NCT02423993|B1|Baseline|SAP + Group Education|"All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
6792|NCT02423993|P4|Participant Flow|CSII + Standart Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6793|NCT02423993|P3|Participant Flow|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6794|NCT02423993|P2|Participant Flow|SAP + Standart Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6856|NCT02423317|B1|Baseline|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6907|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6795|NCT02423993|P1|Participant Flow|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6796|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6797|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6798|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6799|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6800|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6801|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6857|NCT02423317|P2|Participant Flow|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6908|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
9473|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
6802|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6803|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6804|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6805|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6806|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6807|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6808|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6858|NCT02423317|P1|Participant Flow|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6909|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
7154|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
6809|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6810|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6811|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6812|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6813|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6814|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6815|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6859|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6910|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6816|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6817|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6818|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6819|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6820|NCT02423993|E4|Reported Event|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
6821|NCT02423993|E3|Reported Event|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6822|NCT02423993|E2|Reported Event|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
6860|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6911|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
7155|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
6823|NCT02423993|E1|Reported Event|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
6824|NCT02423447|B1|Baseline|All Study Participants|"Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines."
6825|NCT02423447|P2|Participant Flow|G5, Then Electro-Flo|"The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
6826|NCT02423447|P1|Participant Flow|Electro-Flo, Then G5|"The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
6827|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
6828|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
6829|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
6830|NCT02423447|O1|Outcome|Electro-Flo Arm|Electro-Flo arm Electro-Flo device following the 2012 CFF therapy guidelines
6831|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
6832|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
6833|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
6834|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
6835|NCT02423447|O2|Outcome|G5 Flimm Fighter Arm|G5 Flimm Fighter arm
6836|NCT02423447|O1|Outcome|ElectroFlo Arm|ElectroFlo Arm
6837|NCT02423447|E2|Reported Event|G5 Flimm Fighter|G5 Flimm Fighter
6838|NCT02423447|E1|Reported Event|Electro Flo|Electro flo
6839|NCT02423408|B3|Baseline|Total|Total of all reporting groups
6840|NCT02423408|B2|Baseline|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6841|NCT02423408|B1|Baseline|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6842|NCT02423408|P2|Participant Flow|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6843|NCT02423408|P1|Participant Flow|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6844|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6845|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6846|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6847|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6848|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6849|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6850|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6851|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6852|NCT02423408|E2|Reported Event|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
6853|NCT02423408|E1|Reported Event|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
6854|NCT02423317|B3|Baseline|Total|Total of all reporting groups
6880|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6861|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6862|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6863|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6864|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6865|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6866|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6867|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6868|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6869|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6870|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6871|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6872|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6873|NCT02423317|E2|Reported Event|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
6874|NCT02423317|E1|Reported Event|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
6875|NCT02421211|B3|Baseline|Total|Total of all reporting groups
6876|NCT02421211|B2|Baseline|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6877|NCT02421211|B1|Baseline|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6878|NCT02421211|P2|Participant Flow|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6879|NCT02421211|P1|Participant Flow|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6881|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6882|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6883|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6884|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6885|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6886|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6887|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6888|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6889|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6890|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6891|NCT02421211|O1|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6892|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6893|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
6894|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6895|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
6896|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6897|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
6898|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6899|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
6900|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6901|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6902|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6903|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6904|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6905|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6906|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6985|NCT02419001|O1|Outcome|Low Dose|1 g ceftriaxone and two low doses of SYN-004
6912|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6913|NCT02421211|O1|Outcome|Panel 2: 90/400 mg LDV/SOF (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
6914|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6915|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6916|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6917|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6918|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6919|NCT02421211|O1|Outcome|Panel 1: 150 mg SMV + 400 mg SOF (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
6920|NCT02421211|E2|Reported Event|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg - 8 Weeks|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
6921|NCT02421211|E1|Reported Event|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg - 10 Weeks|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
6922|NCT02420093|B3|Baseline|Total|Total of all reporting groups
6923|NCT02420093|B2|Baseline|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6924|NCT02420093|B1|Baseline|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6925|NCT02420093|P2|Participant Flow|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6926|NCT02420093|P1|Participant Flow|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6927|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6928|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6929|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6930|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6931|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6986|NCT02419001|O2|Outcome|High Dose|1 g ceftriaxone and two high doses of SYN-004
6987|NCT02419001|O1|Outcome|Low Dose|1 g ceftriaxone and two low doses of SYN-004
9474|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
6932|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6933|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6934|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6935|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6936|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6937|NCT02420093|E2|Reported Event|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
6938|NCT02420093|E1|Reported Event|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
6939|NCT02420041|B3|Baseline|Total|Total of all reporting groups
6940|NCT02420041|B2|Baseline|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6941|NCT02420041|B1|Baseline|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6942|NCT02420041|P2|Participant Flow|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6943|NCT02420041|P1|Participant Flow|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6944|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6945|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6946|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6988|NCT02419001|E2|Reported Event|High Dose|1 g ceftriaxone and two high doses of SYN-004
6989|NCT02419001|E1|Reported Event|Low Dose|1 g ceftriaxone and two low doses of SYN-004
6947|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6948|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6949|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6950|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6951|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6952|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6953|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6954|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6955|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6956|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6957|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6958|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6959|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6960|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6961|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6962|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6963|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6990|NCT02418676|B4|Baseline|Total|Total of all reporting groups
7010|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
6964|NCT02420041|E2|Reported Event|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
6965|NCT02420041|E1|Reported Event|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
6966|NCT02419313|B1|Baseline|All Study Participants|All participants included in this crossover design.
6967|NCT02419313|P2|Participant Flow|Incobotulinumtoxin A First, Then Placebo|Subjects will all receive injections with incobotulinumtoxinA injections first. At 12 weeks, these subjects will then cross over and receive placebo in the same distribution as their second treatment.
6968|NCT02419313|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Subjects will all receive injections with saline first. At 12 weeks, these subjects will then cross over and receive Xeomin in the same distribution as their second treatment.
6969|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
6970|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
6971|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
6972|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
6973|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
6974|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
6975|NCT02419313|E2|Reported Event|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
6976|NCT02419313|E1|Reported Event|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
6977|NCT02419001|B3|Baseline|Total|Total of all reporting groups
6978|NCT02419001|B2|Baseline|High Dose|1 g ceftriaxone and two high doses of SYN-004
6979|NCT02419001|B1|Baseline|Low Dose|1 g ceftriaxone and two low doses of SYN-004
6980|NCT02419001|P2|Participant Flow|High Dose|1 g ceftriaxone and two high doses of SYN-004
6981|NCT02419001|P1|Participant Flow|Low Dose|1 g ceftriaxone and two low doses of SYN-004
6982|NCT02419001|O2|Outcome|High Dose|1 g ceftriaxone and two high doses of SYN-004
6983|NCT02419001|O1|Outcome|Low Dose|1 g ceftriaxone and two low doses of SYN-004
6984|NCT02419001|O2|Outcome|High Dose|1 g ceftriaxone and two high doses of SYN-004
6991|NCT02418676|B3|Baseline|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6992|NCT02418676|B2|Baseline|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6993|NCT02418676|B1|Baseline|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6994|NCT02418676|P3|Participant Flow|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6995|NCT02418676|P2|Participant Flow|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6996|NCT02418676|P1|Participant Flow|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6997|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6998|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
6999|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7000|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7001|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7002|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7003|NCT02418676|E3|Reported Event|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7004|NCT02418676|E2|Reported Event|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7005|NCT02418676|E1|Reported Event|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
7006|NCT02418234|B1|Baseline|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
7007|NCT02418234|P1|Participant Flow|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
7008|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
7009|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
7011|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
7012|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
7013|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
7014|NCT02418234|O1|Outcome|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
7015|NCT02418234|O1|Outcome|TKI-PD|
7016|NCT02418234|E1|Reported Event|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
7017|NCT02417532|B1|Baseline|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7018|NCT02417532|P1|Participant Flow|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7019|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7020|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7021|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7022|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7023|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7024|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7025|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7026|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7027|NCT02417532|E1|Reported Event|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
7028|NCT02417129|B1|Baseline|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7029|NCT02417129|P2|Participant Flow|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7030|NCT02417129|P1|Participant Flow|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7031|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7032|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7033|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7034|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7035|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7036|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7037|NCT02417129|E2|Reported Event|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7038|NCT02417129|E1|Reported Event|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
7039|NCT02416973|B4|Baseline|Total|Total of all reporting groups
7040|NCT02416973|B3|Baseline|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
7041|NCT02416973|B2|Baseline|Active Treatment|"Active Provant Treatment~Provant"
7042|NCT02416973|B1|Baseline|Sham of Provant|"Sham of Provant~Provant"
7043|NCT02416973|P3|Participant Flow|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
7044|NCT02416973|P2|Participant Flow|Active Treatment|"Active Provant Treatment~Provant"
7045|NCT02416973|P1|Participant Flow|Sham of Provant|"Sham of Provant~Provant"
7046|NCT02416973|O3|Outcome|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
7047|NCT02416973|O2|Outcome|Active Treatment|"Active Provant Treatment~Provant"
7048|NCT02416973|O1|Outcome|Sham of Provant|"Sham of Provant~Provant"
7049|NCT02416973|E3|Reported Event|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
7050|NCT02416973|E2|Reported Event|Active Treatment|"Active Provant Treatment~Provant"
7051|NCT02416973|E1|Reported Event|Sham of Provant|"Sham of Provant~Provant"
9475|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
7052|NCT02416180|B1|Baseline|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7053|NCT02416180|P1|Participant Flow|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via metered dose inhaler (MDI) for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI Patient Information Leaflet (PIL) and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7054|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7055|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7056|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7057|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7058|NCT02416180|E1|Reported Event|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
7059|NCT02415959|B6|Baseline|Total|Total of all reporting groups
7060|NCT02415959|B5|Baseline|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7061|NCT02415959|B4|Baseline|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7062|NCT02415959|B3|Baseline|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7063|NCT02415959|B2|Baseline|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7064|NCT02415959|B1|Baseline|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7065|NCT02415959|P5|Participant Flow|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7066|NCT02415959|P4|Participant Flow|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7067|NCT02415959|P3|Participant Flow|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7068|NCT02415959|P2|Participant Flow|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7069|NCT02415959|P1|Participant Flow|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7070|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7071|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7072|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7073|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7074|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7107|NCT02415439|B7|Baseline|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
7075|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7076|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7077|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7078|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7079|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7080|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7081|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7082|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7083|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7084|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7085|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7086|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7087|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7088|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7089|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7090|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7091|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7092|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7093|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7094|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7095|NCT02415959|E5|Reported Event|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
7096|NCT02415959|E4|Reported Event|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
7097|NCT02415959|E3|Reported Event|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
7098|NCT02415959|E2|Reported Event|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
7099|NCT02415959|E1|Reported Event|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
7100|NCT02415439|B14|Baseline|Total|Total of all reporting groups
7101|NCT02415439|B13|Baseline|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions
7102|NCT02415439|B12|Baseline|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
7103|NCT02415439|B11|Baseline|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
7104|NCT02415439|B10|Baseline|VBP15 - 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
7105|NCT02415439|B9|Baseline|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
7106|NCT02415439|B8|Baseline|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions
7108|NCT02415439|B6|Baseline|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
7109|NCT02415439|B5|Baseline|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
7110|NCT02415439|B4|Baseline|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
7111|NCT02415439|B3|Baseline|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
7112|NCT02415439|B2|Baseline|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
7113|NCT02415439|B1|Baseline|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
7114|NCT02415439|P13|Participant Flow|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions.
7115|NCT02415439|P12|Participant Flow|VBP15- 20 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
7116|NCT02415439|P11|Participant Flow|VBP15- 9.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
7117|NCT02415439|P10|Participant Flow|VBP15- 3.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
7118|NCT02415439|P9|Participant Flow|VBP15- 1.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
7119|NCT02415439|P8|Participant Flow|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
7120|NCT02415439|P7|Participant Flow|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
7121|NCT02415439|P6|Participant Flow|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
7122|NCT02415439|P5|Participant Flow|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
7123|NCT02415439|P4|Participant Flow|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
7124|NCT02415439|P3|Participant Flow|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
7125|NCT02415439|P2|Participant Flow|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7126|NCT02415439|P1|Participant Flow|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
7127|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
7128|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
7129|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
7130|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
7131|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
7132|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
7133|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
7134|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
7135|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
7136|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
7137|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
7138|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
7139|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
7140|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
7141|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
7142|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
7143|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7144|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
7145|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
7146|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
7147|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
7148|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7149|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
7150|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
7151|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7152|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
9476|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
7158|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
7159|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7160|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
7161|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
7162|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
7163|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
7164|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7165|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
7166|NCT02415439|E13|Reported Event|Placebo MAD|Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
7167|NCT02415439|E12|Reported Event|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
7168|NCT02415439|E11|Reported Event|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
7169|NCT02415439|E10|Reported Event|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
7170|NCT02415439|E9|Reported Event|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
7171|NCT02415439|E8|Reported Event|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
7172|NCT02415439|E7|Reported Event|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7173|NCT02415439|E6|Reported Event|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
7174|NCT02415439|E5|Reported Event|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
7175|NCT02415439|E4|Reported Event|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
7176|NCT02415439|E3|Reported Event|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
7177|NCT02415439|E2|Reported Event|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
7178|NCT02415439|E1|Reported Event|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
7179|NCT02414828|B5|Baseline|Total|Total of all reporting groups
7180|NCT02414828|B4|Baseline|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7181|NCT02414828|B3|Baseline|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7182|NCT02414828|B2|Baseline|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7183|NCT02414828|B1|Baseline|Placebo|Sterile buffer, Intramuscular (IM)
7184|NCT02414828|P4|Participant Flow|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7185|NCT02414828|P3|Participant Flow|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7186|NCT02414828|P2|Participant Flow|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7187|NCT02414828|P1|Participant Flow|Placebo|Sterile buffer, Intramuscular (IM)
7188|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7189|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7190|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7191|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7192|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7193|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7194|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7195|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7196|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7197|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7198|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7199|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7200|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7201|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7202|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7203|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7204|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7205|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7206|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7207|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7208|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7209|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7210|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7211|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7212|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7213|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7214|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7215|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
7216|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
7217|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
7218|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
7224|NCT02414152|B1|Baseline|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
7225|NCT02414152|P1|Participant Flow|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
7226|NCT02414152|O1|Outcome|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
7227|NCT02414152|E1|Reported Event|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
7228|NCT02413593|B1|Baseline|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7229|NCT02413593|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7230|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7231|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7232|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7233|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7234|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7235|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7236|NCT02413593|E1|Reported Event|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
7237|NCT02413333|B5|Baseline|Total|Total of all reporting groups
7238|NCT02413333|B4|Baseline|PeroxiClear, Then PeroxiClear|PeroxiClear was used in Period 1 and in Period 2.
7239|NCT02413333|B3|Baseline|Clear Care Plus, Then Clear Care Plus|Clear Care Plus was used in Period 1 and in Period 2.
7240|NCT02413333|B2|Baseline|PeroxiClear, Then Clear Care Plus|PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.
7241|NCT02413333|B1|Baseline|Clear Care Plus, Then PeroxiClear|Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.
7242|NCT02413333|P2|Participant Flow|PeroxiClear, Then Clear Care Plus|PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
7243|NCT02413333|P1|Participant Flow|Clear Care Plus, Then PeroxiClear|Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
7244|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
7245|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
7246|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
7247|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
7248|NCT02413333|E2|Reported Event|Clear Care Plus|While using Clear Care Plus
7249|NCT02413333|E1|Reported Event|PeroxiClear|While using PeroxiClear
7250|NCT02413034|B3|Baseline|Total|Total of all reporting groups
7251|NCT02413034|B2|Baseline|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
7252|NCT02413034|B1|Baseline|Control Group|No antibiotic prophylaxis
7253|NCT02413034|P2|Participant Flow|Study Group|Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
7254|NCT02413034|P1|Participant Flow|Control Group|No antibiotic prophylaxis
7255|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
7256|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
7257|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
7258|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
7259|NCT02413034|E2|Reported Event|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
7260|NCT02413034|E1|Reported Event|Control Group|No antibiotic prophylaxis
7261|NCT02412657|B4|Baseline|Total|Total of all reporting groups
7262|NCT02412657|B3|Baseline|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
7263|NCT02412657|B2|Baseline|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7264|NCT02412657|B1|Baseline|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7265|NCT02412657|P3|Participant Flow|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
7318|NCT02406937|P2|Participant Flow|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7372|NCT02406937|E2|Reported Event|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7266|NCT02412657|P2|Participant Flow|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7267|NCT02412657|P1|Participant Flow|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7268|NCT02412657|O3|Outcome|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
7269|NCT02412657|O2|Outcome|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7270|NCT02412657|O1|Outcome|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7271|NCT02412657|E3|Reported Event|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
7272|NCT02412657|E2|Reported Event|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7273|NCT02412657|E1|Reported Event|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
7274|NCT02411929|B1|Baseline|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
7275|NCT02411929|P1|Participant Flow|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
7276|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
7277|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
7278|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
7279|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
7280|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7281|NCT02411929|O1|Outcome|14^C-Ertugliflozin 100 ug Oral|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C administered orally after the unlabeled oral dose (no more than 5 minutes apart) on Day 1 of Period 2.
7282|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7283|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7284|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7285|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
9477|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
7286|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7287|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7288|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7289|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7290|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7291|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7292|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7293|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7294|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7295|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7296|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7297|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7298|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7299|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7300|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
7301|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
7302|NCT02411929|E2|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
7303|NCT02411929|E1|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
7304|NCT02411747|B3|Baseline|Total|Total of all reporting groups
7305|NCT02411747|B2|Baseline|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
7306|NCT02411747|B1|Baseline|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
7307|NCT02411747|P2|Participant Flow|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
7308|NCT02411747|P1|Participant Flow|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
7309|NCT02411747|O2|Outcome|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
7310|NCT02411747|O1|Outcome|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
7311|NCT02411747|E2|Reported Event|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
7312|NCT02411747|E1|Reported Event|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
7313|NCT02406937|B4|Baseline|Total|Total of all reporting groups
7314|NCT02406937|B3|Baseline|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7315|NCT02406937|B2|Baseline|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7316|NCT02406937|B1|Baseline|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7317|NCT02406937|P3|Participant Flow|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7319|NCT02406937|P1|Participant Flow|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7320|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Breast Feeding: Oral intake of breast milk"
7321|NCT02406937|O2|Outcome|Feihe Stage 1 Formula|"Oral intake of Feihe stage 1 formula~Oral intake of Feihe Stage 1 Formula: Oral intake of Feihe Stage 1 Formula"
7322|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake of Feihe New Formula: Oral intake of Feihe New Formula"
7323|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7324|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7325|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7326|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7327|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7328|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7329|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7330|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7331|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7332|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7333|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7334|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7335|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7336|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7337|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7338|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7339|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7340|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7341|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7342|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7343|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7344|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7345|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7346|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7347|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7348|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7349|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7350|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7351|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7352|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7353|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7354|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7355|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7356|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7357|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7358|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7359|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7360|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7361|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7362|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7363|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7364|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7365|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7366|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7367|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7368|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7369|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
7370|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7371|NCT02406937|E3|Reported Event|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
7373|NCT02406937|E1|Reported Event|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
7374|NCT02406586|B4|Baseline|Total|Total of all reporting groups
7375|NCT02406586|B3|Baseline|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7376|NCT02406586|B2|Baseline|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7377|NCT02406586|B1|Baseline|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7378|NCT02406586|P3|Participant Flow|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7379|NCT02406586|P2|Participant Flow|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7380|NCT02406586|P1|Participant Flow|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7381|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7382|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7383|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7384|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7385|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7386|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7387|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7388|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7389|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7390|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7453|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7974|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
7391|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7392|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7393|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7394|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7395|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7396|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7397|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7398|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7399|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7400|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7401|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7402|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7403|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7404|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7405|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7406|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7407|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7975|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
7408|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7409|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7410|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7411|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7412|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7413|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7414|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7415|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7416|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7417|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7418|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7419|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7420|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7421|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7422|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7423|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7424|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7454|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7425|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7426|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7427|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7428|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7429|NCT02406586|E3|Reported Event|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
7430|NCT02406586|E2|Reported Event|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7431|NCT02406586|E1|Reported Event|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
7432|NCT02406495|B1|Baseline|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7433|NCT02406495|P1|Participant Flow|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7434|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7435|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7436|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7437|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7438|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7439|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7440|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7441|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7442|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7443|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7444|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7445|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7446|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7447|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7448|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7449|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7450|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7451|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7452|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7914|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7455|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7456|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7457|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7458|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7459|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7460|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7461|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7462|NCT02406495|O4|Outcome|Ocufilcon D OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7463|NCT02406495|O3|Outcome|Ocufilcon D OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7464|NCT02406495|O2|Outcome|Filcon IV 1 OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7465|NCT02406495|O1|Outcome|Filcon IV 1 OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7466|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7467|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7468|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7469|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7470|NCT02406495|E1|Reported Event|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
7471|NCT02404649|B3|Baseline|Total|Total of all reporting groups
7472|NCT02404649|B2|Baseline|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
7473|NCT02404649|B1|Baseline|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
7474|NCT02404649|P2|Participant Flow|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
7475|NCT02404649|P1|Participant Flow|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
7499|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7976|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
7476|NCT02404649|O2|Outcome|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
7477|NCT02404649|O1|Outcome|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
7478|NCT02404649|E2|Reported Event|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
7479|NCT02404649|E1|Reported Event|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
7480|NCT02403180|B3|Baseline|Total|Total of all reporting groups
7481|NCT02403180|B2|Baseline|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
7482|NCT02403180|B1|Baseline|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
7483|NCT02403180|P2|Participant Flow|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
7484|NCT02403180|P1|Participant Flow|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
7485|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7486|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7487|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7488|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7489|NCT02403180|E2|Reported Event|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7490|NCT02403180|E1|Reported Event|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
7491|NCT02402322|B4|Baseline|Total|Total of all reporting groups
7492|NCT02402322|B3|Baseline|Waiting List|Participants in a waiting list.
7493|NCT02402322|B2|Baseline|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7494|NCT02402322|B1|Baseline|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7495|NCT02402322|P3|Participant Flow|Waiting List|Participants in a waiting list.
7496|NCT02402322|P2|Participant Flow|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7497|NCT02402322|P1|Participant Flow|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7498|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7915|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7500|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7501|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7502|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7503|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7504|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7505|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7506|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7507|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7508|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7509|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7510|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7511|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7512|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7513|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7514|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7515|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7516|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7517|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7518|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7519|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7520|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7521|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7522|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
7523|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7524|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7525|NCT02402322|E3|Reported Event|Waiting List|Participants in a waiting list.
7547|NCT02402127|B3|Baseline|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
7526|NCT02402322|E2|Reported Event|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
7527|NCT02402322|E1|Reported Event|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
7528|NCT02402296|B3|Baseline|Total|Total of all reporting groups
7529|NCT02402296|B2|Baseline|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7530|NCT02402296|B1|Baseline|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7531|NCT02402296|P2|Participant Flow|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7532|NCT02402296|P1|Participant Flow|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7533|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7534|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7535|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7536|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7537|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7538|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7539|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7540|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7541|NCT02402296|E2|Reported Event|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
7542|NCT02402296|E1|Reported Event|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
7543|NCT02402127|B7|Baseline|Total|Total of all reporting groups
7544|NCT02402127|B6|Baseline|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
7545|NCT02402127|B5|Baseline|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
7546|NCT02402127|B4|Baseline|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
7548|NCT02402127|B2|Baseline|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
7549|NCT02402127|B1|Baseline|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
7550|NCT02402127|P6|Participant Flow|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
7551|NCT02402127|P5|Participant Flow|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
7552|NCT02402127|P4|Participant Flow|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
7553|NCT02402127|P3|Participant Flow|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
7554|NCT02402127|P2|Participant Flow|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
7555|NCT02402127|P1|Participant Flow|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
7556|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses
7557|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses
7558|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses
7559|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
7560|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
7561|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
7562|NCT02402127|E3|Reported Event|Clariti 1day|Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
7563|NCT02402127|E2|Reported Event|MyDay|Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
7564|NCT02402127|E1|Reported Event|TruEye|Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
7565|NCT02401529|B3|Baseline|Total|Total of all reporting groups
7566|NCT02401529|B2|Baseline|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7567|NCT02401529|B1|Baseline|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7568|NCT02401529|P2|Participant Flow|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7569|NCT02401529|P1|Participant Flow|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7570|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7571|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7572|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7573|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7574|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7575|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~Number of participants when started 59"
7576|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7577|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7578|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7629|NCT02401464|E4|Reported Event|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7579|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7580|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7581|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7582|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7583|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7584|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7585|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7586|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7587|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7588|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7589|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7590|NCT02401529|E2|Reported Event|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
7591|NCT02401529|E1|Reported Event|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
7592|NCT02401464|B5|Baseline|Total|Total of all reporting groups
7593|NCT02401464|B4|Baseline|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7594|NCT02401464|B3|Baseline|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7595|NCT02401464|B2|Baseline|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7596|NCT02401464|B1|Baseline|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7597|NCT02401464|P4|Participant Flow|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7598|NCT02401464|P3|Participant Flow|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7630|NCT02401464|E3|Reported Event|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7977|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
7599|NCT02401464|P2|Participant Flow|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7600|NCT02401464|P1|Participant Flow|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
7601|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7602|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7603|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7604|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7605|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7606|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7607|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7608|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7609|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7610|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7611|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7612|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7613|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7614|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7615|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7616|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7617|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7618|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7619|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7620|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7621|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7622|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7623|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7624|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7625|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7626|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7627|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7628|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7916|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7631|NCT02401464|E2|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
7632|NCT02401464|E1|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
7633|NCT02400996|B1|Baseline|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
7634|NCT02400996|P1|Participant Flow|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
7635|NCT02400996|O1|Outcome|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
7636|NCT02400996|E1|Reported Event|Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
7637|NCT02400710|B3|Baseline|Total|Total of all reporting groups
7638|NCT02400710|B2|Baseline|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
7639|NCT02400710|B1|Baseline|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
7640|NCT02400710|P2|Participant Flow|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
7641|NCT02400710|P1|Participant Flow|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
7642|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
7643|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
7644|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
7645|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
7646|NCT02400710|E2|Reported Event|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
7647|NCT02400710|E1|Reported Event|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
7648|NCT02400333|B5|Baseline|Total|Total of all reporting groups
7649|NCT02400333|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
7650|NCT02400333|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
7651|NCT02400333|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
7652|NCT02400333|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
7653|NCT02400333|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
7654|NCT02400333|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
7655|NCT02400333|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
7656|NCT02400333|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
7657|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7658|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7659|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7660|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7661|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7662|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7663|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7664|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7665|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7666|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7667|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7668|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7669|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7670|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7671|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7672|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7673|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7674|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7675|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7676|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7677|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7678|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7679|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7680|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7681|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7682|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7683|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7684|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7685|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7686|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7687|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7688|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7689|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7690|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7691|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7692|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7693|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7694|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7695|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7696|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7697|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7698|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7699|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7700|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7701|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7702|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7703|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7704|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7705|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7706|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a nasogastric tube (NG) tube into the stomach (total of 200 mL of water).
7707|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7708|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7709|NCT02400333|E4|Reported Event|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
7710|NCT02400333|E3|Reported Event|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
7711|NCT02400333|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
7712|NCT02400333|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
7713|NCT02399345|B1|Baseline|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7714|NCT02399345|P1|Participant Flow|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7715|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7716|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7717|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7718|NCT02399345|E1|Reported Event|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
7719|NCT02399163|B1|Baseline|Overall Participants|All randomized participants were evaluated for baseline characteristics
7720|NCT02399163|P1|Participant Flow|Overall Study|"In this cross-over study, participants were randomized to receive each of following treatments:~Fluoride dentifrice/Fluoride rinse~Placebo dentifrice/Fluoride rinse~Fluoride dentifrice/No rinse~Placebo dentifrice/No rinse"
7721|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7722|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
7723|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7797|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7724|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7725|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
7726|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
7727|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7728|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7729|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
7730|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
7731|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7732|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7733|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
7734|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
7735|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7736|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7737|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7738|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
7739|NCT02399163|E4|Reported Event|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
7740|NCT02399163|E3|Reported Event|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
7741|NCT02399163|E2|Reported Event|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
7742|NCT02399163|E1|Reported Event|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
7743|NCT02399111|B5|Baseline|Total|Total of all reporting groups
7744|NCT02399111|B4|Baseline|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7745|NCT02399111|B3|Baseline|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7746|NCT02399111|B2|Baseline|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
7747|NCT02399111|B1|Baseline|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
7748|NCT02399111|P4|Participant Flow|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7798|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7966|NCT02393950|B3|Baseline|Total|Total of all reporting groups
7749|NCT02399111|P3|Participant Flow|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7750|NCT02399111|P2|Participant Flow|Obese:BMI≥30; Standard Care|Obese: BMI ≥30; Standard Wound Care
7751|NCT02399111|P1|Participant Flow|Not Obese:BMI<30; Standard Care|Not obese: BMI< 30; Standard Wound Care
7752|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7753|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7754|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Standard Wound Care
7755|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Standard Wound Care
7756|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7757|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7758|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
7759|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
7760|NCT02399111|E4|Reported Event|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7761|NCT02399111|E3|Reported Event|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
7762|NCT02399111|E2|Reported Event|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
7763|NCT02399111|E1|Reported Event|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
7799|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7800|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
9478|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
7764|NCT02397915|B1|Baseline|FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg|All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray.
7765|NCT02397915|P4|Participant Flow|Period 2: FF 110 µg|Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
7766|NCT02397915|P3|Participant Flow|Period 2: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
7767|NCT02397915|P2|Participant Flow|Period 1: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7768|NCT02397915|P1|Participant Flow|Period 1: FF 110 µg|Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7769|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7770|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7771|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7772|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7773|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7774|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7775|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7776|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7777|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7778|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7779|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7780|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7781|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7782|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7783|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7784|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7785|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7786|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7787|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7788|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7789|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7790|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7791|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7792|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7793|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7794|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7795|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7796|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7967|NCT02393950|B2|Baseline|Panel 2|Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
7801|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7802|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7803|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7804|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7805|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7806|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7807|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7808|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7809|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7810|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7811|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7812|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7813|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7814|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
7815|NCT02397915|E2|Reported Event|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7816|NCT02397915|E1|Reported Event|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
7817|NCT02397655|B1|Baseline|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
7818|NCT02397655|P1|Participant Flow|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
7819|NCT02397655|O1|Outcome|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
7820|NCT02397655|E1|Reported Event|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
7821|NCT02396160|B3|Baseline|Total|Total of all reporting groups
7822|NCT02396160|B2|Baseline|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7823|NCT02396160|B1|Baseline|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7824|NCT02396160|P2|Participant Flow|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7825|NCT02396160|P1|Participant Flow|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7826|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7827|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7828|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7829|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7830|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7831|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7832|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7833|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7834|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7835|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7836|NCT02396160|E2|Reported Event|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
7837|NCT02396160|E1|Reported Event|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
7838|NCT02396147|B3|Baseline|Total|Total of all reporting groups
7839|NCT02396147|B2|Baseline|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
7840|NCT02396147|B1|Baseline|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
7841|NCT02396147|P2|Participant Flow|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
7842|NCT02396147|P1|Participant Flow|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
7843|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7844|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7845|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7846|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7847|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7848|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7849|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7850|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7851|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7852|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
9479|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
7853|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7854|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7855|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7856|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7857|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7858|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7859|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7860|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7861|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7862|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7863|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7864|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7865|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7866|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7867|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7868|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7869|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7870|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7871|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7872|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7873|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7874|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7875|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7876|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7877|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7878|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7879|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7880|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7881|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7882|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7883|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7884|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7885|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7886|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7887|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7888|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7889|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7890|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7891|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7892|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7893|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7894|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7895|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7896|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7897|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7898|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7899|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7900|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7901|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7902|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7903|NCT02396147|E6|Reported Event|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7904|NCT02396147|E5|Reported Event|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7905|NCT02396147|E4|Reported Event|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7906|NCT02396147|E3|Reported Event|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7907|NCT02396147|E2|Reported Event|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7908|NCT02396147|E1|Reported Event|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
7909|NCT02395055|B3|Baseline|Total|Total of all reporting groups
7910|NCT02395055|B2|Baseline|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7911|NCT02395055|B1|Baseline|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7912|NCT02395055|P2|Participant Flow|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7913|NCT02395055|P1|Participant Flow|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7968|NCT02393950|B1|Baseline|Panel 1|Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
7917|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7918|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7919|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7920|NCT02395055|E2|Reported Event|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7921|NCT02395055|E1|Reported Event|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
7922|NCT02394665|B4|Baseline|Total|Total of all reporting groups
7923|NCT02394665|B3|Baseline|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7924|NCT02394665|B2|Baseline|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7925|NCT02394665|B1|Baseline|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7926|NCT02394665|P3|Participant Flow|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7927|NCT02394665|P2|Participant Flow|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7928|NCT02394665|P1|Participant Flow|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7929|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7930|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7931|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7932|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7933|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7934|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7935|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7936|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7937|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7969|NCT02393950|P2|Participant Flow|Panel 2|Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
7970|NCT02393950|P1|Participant Flow|Panel 1|Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
7971|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
7938|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7939|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7940|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7941|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7942|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7943|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7944|NCT02394665|E3|Reported Event|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7945|NCT02394665|E2|Reported Event|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
7946|NCT02394665|E1|Reported Event|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
7947|NCT02394457|B3|Baseline|Total|Total of all reporting groups
7948|NCT02394457|B2|Baseline|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7949|NCT02394457|B1|Baseline|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7950|NCT02394457|P2|Participant Flow|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7951|NCT02394457|P1|Participant Flow|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7952|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7953|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7954|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7955|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7956|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7957|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7958|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7959|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7960|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7961|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7962|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7963|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7964|NCT02394457|E2|Reported Event|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
7965|NCT02394457|E1|Reported Event|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
7978|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
7979|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
7980|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
7981|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
7982|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B.
7983|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
7984|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B.
7985|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B.
7986|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.
7987|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B.
7988|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B.
7989|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
7990|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
7991|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
7992|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
7993|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
7994|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
7995|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B
7996|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
7997|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
7998|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
7999|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
8000|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
8001|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
8002|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
8003|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
8004|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
8005|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
8006|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
8007|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
8008|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
8009|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
8010|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
8011|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
8012|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
8013|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
8014|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
8015|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
8016|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
8017|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
8018|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
8019|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
8020|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
8021|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
8022|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
8023|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
8024|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
8025|NCT02393950|E9|Reported Event|Placebo|2 placebo subjects per Arm with matched number of placebo capsules
8026|NCT02393950|E8|Reported Event|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
8027|NCT02393950|E7|Reported Event|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
8028|NCT02393950|E6|Reported Event|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
8029|NCT02393950|E5|Reported Event|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
8030|NCT02393950|E4|Reported Event|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
8031|NCT02393950|E3|Reported Event|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
8032|NCT02393950|E2|Reported Event|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
8033|NCT02393950|E1|Reported Event|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
8034|NCT02393677|B3|Baseline|Total|Total of all reporting groups
8035|NCT02393677|B2|Baseline|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
8036|NCT02393677|B1|Baseline|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
8162|NCT02388763|E5|Reported Event|1DAVTE|Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
8037|NCT02393677|P2|Participant Flow|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
8038|NCT02393677|P1|Participant Flow|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
8039|NCT02393677|O2|Outcome|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
8040|NCT02393677|O1|Outcome|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
8041|NCT02393677|E2|Reported Event|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
8042|NCT02393677|E1|Reported Event|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
8043|NCT02392767|B3|Baseline|Total|Total of all reporting groups
8044|NCT02392767|B2|Baseline|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
8045|NCT02392767|B1|Baseline|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
8046|NCT02392767|P2|Participant Flow|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
8047|NCT02392767|P1|Participant Flow|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
8048|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
8049|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8050|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
8051|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8052|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
8053|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8054|NCT02392767|O2|Outcome|Placebo|2 times 2 tablets a day for 4 weeks. Placebo: corn starch
8055|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8056|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
8057|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8058|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
8059|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8060|NCT02392767|E2|Reported Event|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
8061|NCT02392767|E1|Reported Event|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
8062|NCT02392247|B1|Baseline|Cardiac Surgery Patients|Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
8063|NCT02392247|P1|Participant Flow|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
8064|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
8065|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
8066|NCT02392247|E1|Reported Event|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry~Blood specimen collection"
8067|NCT02391714|B3|Baseline|Total|Total of all reporting groups
8106|NCT02389361|E1|Reported Event|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
8107|NCT02389088|B1|Baseline|Phase I|9 PCOS women
8068|NCT02391714|B2|Baseline|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
8069|NCT02391714|B1|Baseline|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
8070|NCT02391714|P2|Participant Flow|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
8071|NCT02391714|P1|Participant Flow|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
8072|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
8073|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
8074|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
8085|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8158|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
8159|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
8160|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
8075|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
8076|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
8077|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
8078|NCT02391714|E2|Reported Event|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
8079|NCT02391714|E1|Reported Event|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
8080|NCT02389452|B1|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8081|NCT02389452|P1|Participant Flow|Synvisc-One|Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8082|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8083|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8084|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8105|NCT02389361|E2|Reported Event|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
8161|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
8086|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8087|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8088|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8089|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8090|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8091|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8092|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8093|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8094|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8095|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
8096|NCT02389452|E2|Reported Event|Synvisc-One: Local Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint.
8097|NCT02389452|E1|Reported Event|Synvisc-One: Systemic Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint.
8098|NCT02389361|B3|Baseline|Total|Total of all reporting groups
8099|NCT02389361|B2|Baseline|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
8100|NCT02389361|B1|Baseline|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
8101|NCT02389361|P2|Participant Flow|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
8102|NCT02389361|P1|Participant Flow|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
8103|NCT02389361|O2|Outcome|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
8104|NCT02389361|O1|Outcome|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
8108|NCT02389088|P1|Participant Flow|Phase I - All Study Participants|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
8109|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
8110|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
8111|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
8112|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
8113|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
8114|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
8115|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
8116|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
8117|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
8118|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
8119|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
8120|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
8121|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
8122|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
8123|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
8124|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
8125|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
8126|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
8127|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
8128|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
8129|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
8130|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
8131|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
8132|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
8133|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
8134|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
8135|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
8136|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
8137|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
8138|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
8139|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
8140|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
8141|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
8142|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
8143|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
8144|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
8145|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
8146|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
8147|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
8148|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
8149|NCT02389088|E2|Reported Event|Phase II|"Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.~After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).~Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days"
8150|NCT02389088|E1|Reported Event|Phase I|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
8151|NCT02388815|B1|Baseline|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
8152|NCT02388815|P1|Participant Flow|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
8153|NCT02388815|O1|Outcome|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
8154|NCT02388815|E1|Reported Event|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
8155|NCT02388763|B1|Baseline|Overall|Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
8156|NCT02388763|P2|Participant Flow|Habitual, 1DAVTE, MyDay|Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
8157|NCT02388763|P1|Participant Flow|Habitual, MyDay, 1DAVTE|Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
9480|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
8163|NCT02388763|E4|Reported Event|MyDay|Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
8164|NCT02388763|E3|Reported Event|Clariti 1-Day|Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
8165|NCT02388763|E2|Reported Event|Dailies Total 1|Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
8166|NCT02388763|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
8167|NCT02388074|B1|Baseline|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
8168|NCT02388074|P1|Participant Flow|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
8169|NCT02388074|O1|Outcome|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
8170|NCT02388074|E1|Reported Event|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
8171|NCT02387801|B3|Baseline|Total|Total of all reporting groups
8172|NCT02387801|B2|Baseline|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 12.
8173|NCT02387801|B1|Baseline|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 44. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8174|NCT02387801|P2|Participant Flow|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
8175|NCT02387801|P1|Participant Flow|Ixekizumab Q2W|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8176|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8177|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8178|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8179|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8180|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8181|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8182|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8183|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8184|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8185|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8186|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8187|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8188|NCT02387801|E2|Reported Event|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
8189|NCT02387801|E1|Reported Event|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
8190|NCT02387580|B7|Baseline|Total|Total of all reporting groups
8191|NCT02387580|B6|Baseline|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
8192|NCT02387580|B5|Baseline|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8193|NCT02387580|B4|Baseline|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8446|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
8194|NCT02387580|B3|Baseline|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8195|NCT02387580|B2|Baseline|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8196|NCT02387580|B1|Baseline|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8197|NCT02387580|P6|Participant Flow|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8198|NCT02387580|P5|Participant Flow|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8199|NCT02387580|P4|Participant Flow|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8200|NCT02387580|P3|Participant Flow|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8201|NCT02387580|P2|Participant Flow|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8202|NCT02387580|P1|Participant Flow|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8203|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8204|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8205|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8206|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8207|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8208|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8209|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8210|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8211|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8212|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8213|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8214|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8215|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8216|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8217|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8218|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8219|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8220|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8221|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
8222|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8223|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8224|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8225|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8226|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8227|NCT02387580|E6|Reported Event|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8228|NCT02387580|E5|Reported Event|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8229|NCT02387580|E4|Reported Event|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8230|NCT02387580|E3|Reported Event|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8231|NCT02387580|E2|Reported Event|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8232|NCT02387580|E1|Reported Event|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
8233|NCT02387554|B5|Baseline|Total|Total of all reporting groups
8234|NCT02387554|B4|Baseline|Sequence 4|Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L
8235|NCT02387554|B3|Baseline|Sequence 3|Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A
8236|NCT02387554|B2|Baseline|Sequence 2|Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC
8237|NCT02387554|B1|Baseline|Sequence 1|Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C
8238|NCT02387554|P4|Participant Flow|Sequence 4|Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
8239|NCT02387554|P3|Participant Flow|Sequence 3|Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)
8240|NCT02387554|P2|Participant Flow|Sequence 2|Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)
8241|NCT02387554|P1|Participant Flow|Sequence 1|Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)
8242|NCT02387554|O4|Outcome|EXP3174|EXP3174(losartan active metabolite) ratio in single or combination
8243|NCT02387554|O3|Outcome|HGP1405|HGP1405(chlorthalidone) ratio in single or combination
8244|NCT02387554|O2|Outcome|HGP0608|HGP0608(losartan) ratio in single or combination
8245|NCT02387554|O1|Outcome|HGP0904|HGP0904(amlodipine) ratio in single or combination
8246|NCT02387554|E4|Reported Event|HGP0904+HGP0608+HGP1405|"amlodipine + losartan + chlorthalidone~HGP0904~HGP0608~HGP1405"
8247|NCT02387554|E3|Reported Event|HGP1405|"chlorthalidone~HGP1405"
8248|NCT02387554|E2|Reported Event|HGP0608|"losartan~HGP0608"
8249|NCT02387554|E1|Reported Event|HGP0904|"amlodipine~HGP0904"
8250|NCT02387502|B4|Baseline|Total|Total of all reporting groups
8251|NCT02387502|B3|Baseline|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
8252|NCT02387502|B2|Baseline|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
8253|NCT02387502|B1|Baseline|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
8254|NCT02387502|P3|Participant Flow|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
8255|NCT02387502|P2|Participant Flow|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
8272|NCT02384070|P3|Participant Flow|Group 3: Upstream Aspirin Plus Bivalirudin|Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
8273|NCT02384070|P2|Participant Flow|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
8424|NCT02380287|B3|Baseline|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
8256|NCT02387502|P1|Participant Flow|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
8257|NCT02387502|O3|Outcome|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
8258|NCT02387502|O2|Outcome|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
8259|NCT02387502|O1|Outcome|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
8260|NCT02387502|E3|Reported Event|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
8261|NCT02387502|E2|Reported Event|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
8262|NCT02387502|E1|Reported Event|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
8263|NCT02387268|B1|Baseline|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
8264|NCT02387268|P1|Participant Flow|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
8265|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
8266|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
8267|NCT02387268|E1|Reported Event|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
8268|NCT02384070|B4|Baseline|Total|Total of all reporting groups
8269|NCT02384070|B3|Baseline|Group 3: Upstream Aspirin Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8270|NCT02384070|B2|Baseline|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8271|NCT02384070|B1|Baseline|Group 1: Upstream Aspirin + Clopidrogel|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
8425|NCT02380287|B2|Baseline|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
8274|NCT02384070|P1|Participant Flow|Group 1: Upstream Aspirin + Clopidrogel|Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
8275|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8276|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8277|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
8278|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8279|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8280|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
8281|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8282|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8283|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
8284|NCT02384070|E3|Reported Event|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8285|NCT02384070|E2|Reported Event|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
8286|NCT02384070|E1|Reported Event|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
8287|NCT02383719|B1|Baseline|Oro-nasal Mask|Oro-nasal Mask
8288|NCT02383719|P1|Participant Flow|Oro-nasal Mask|Oro-nasal Mask
8289|NCT02383719|O1|Outcome|Oro-nasal Mask|All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
8290|NCT02383719|E1|Reported Event|Oro-nasal Mask|Oro-nasal Mask
8291|NCT02383420|B4|Baseline|Total|Total of all reporting groups
8292|NCT02383420|B3|Baseline|Predicate & Invest.-Cadavers GOS & CsI|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
8293|NCT02383420|B2|Baseline|Predicate & Invest.-CsI|Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
8294|NCT02383420|B1|Baseline|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
8295|NCT02383420|P3|Participant Flow|Predicate & Investigational-Cadavers|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
8296|NCT02383420|P2|Participant Flow|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
8297|NCT02383420|P1|Participant Flow|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
8298|NCT02383420|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-PRO 3543/C (GOS & CsI) and vice versa.
8299|NCT02383420|O2|Outcome|Investigational|DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers
8300|NCT02383420|O1|Outcome|Predicate|DRX-1 Detector, Live Subjects and Cadavers
8301|NCT02383420|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
8302|NCT02383420|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
8303|NCT02383420|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
8304|NCT02382913|B11|Baseline|Total|Total of all reporting groups
8386|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8305|NCT02382913|B10|Baseline|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8306|NCT02382913|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8307|NCT02382913|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8308|NCT02382913|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8309|NCT02382913|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8310|NCT02382913|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8311|NCT02382913|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8312|NCT02382913|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8313|NCT02382913|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8314|NCT02382913|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8315|NCT02382913|P10|Participant Flow|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8316|NCT02382913|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8317|NCT02382913|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8318|NCT02382913|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8319|NCT02382913|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8320|NCT02382913|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8321|NCT02382913|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8322|NCT02382913|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8323|NCT02382913|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8324|NCT02382913|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8325|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8326|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8327|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
9481|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
8328|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8329|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8330|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8331|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8332|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8333|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8334|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8335|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8336|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8337|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8338|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8339|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8340|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8341|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8342|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8343|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8344|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8345|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8346|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8347|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8348|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8349|NCT02382913|E10|Reported Event|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8350|NCT02382913|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
9482|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
8351|NCT02382913|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8352|NCT02382913|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8353|NCT02382913|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8354|NCT02382913|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8355|NCT02382913|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8356|NCT02382913|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8357|NCT02382913|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8358|NCT02382913|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
8359|NCT02382640|B5|Baseline|Total|Total of all reporting groups
8360|NCT02382640|B4|Baseline|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
8361|NCT02382640|B3|Baseline|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
8362|NCT02382640|B2|Baseline|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
8363|NCT02382640|B1|Baseline|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
8364|NCT02382640|P4|Participant Flow|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
8387|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8365|NCT02382640|P3|Participant Flow|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
8366|NCT02382640|P2|Participant Flow|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
8367|NCT02382640|P1|Participant Flow|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
8368|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8369|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8370|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8371|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8372|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8373|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8374|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8375|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8376|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8377|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8378|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8379|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8380|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8381|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8382|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8383|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8384|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8385|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
9483|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
8388|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8389|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8390|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8391|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8392|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8393|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8394|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8395|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8396|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8397|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8398|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8399|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8400|NCT02382640|E4|Reported Event|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
8401|NCT02382640|E3|Reported Event|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
8402|NCT02382640|E2|Reported Event|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
8403|NCT02382640|E1|Reported Event|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
8404|NCT02381678|B1|Baseline|All Patients Enrolled in Study|The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
8405|NCT02381678|P3|Participant Flow|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
8406|NCT02381678|P2|Participant Flow|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
8407|NCT02381678|P1|Participant Flow|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
8408|NCT02381678|O1|Outcome|One-arm Group Included All Enrolled Subjects|This group included total 225 enrolled participants
8409|NCT02381678|E3|Reported Event|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
8410|NCT02381678|E2|Reported Event|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
8411|NCT02381678|E1|Reported Event|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
8412|NCT02381418|B1|Baseline|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
8413|NCT02381418|P1|Participant Flow|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
8414|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
8415|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 ~Trivalent influenza subunit vaccine Influvac: 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
8416|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
8417|NCT02381418|E1|Reported Event|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
8418|NCT02380287|B9|Baseline|Total|Total of all reporting groups
8419|NCT02380287|B8|Baseline|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
8420|NCT02380287|B7|Baseline|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
8421|NCT02380287|B6|Baseline|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
8422|NCT02380287|B5|Baseline|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
8423|NCT02380287|B4|Baseline|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
8426|NCT02380287|B1|Baseline|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
8427|NCT02380287|P8|Participant Flow|Cohort no.8|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.~humanized monoclonal antibody against human IL-17"
8428|NCT02380287|P7|Participant Flow|Cohort no.7|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.~humanized monoclonal antibody against human IL-17"
8429|NCT02380287|P6|Participant Flow|Cohort no.6|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.~humanized monoclonal antibody against human IL-17"
8430|NCT02380287|P5|Participant Flow|Cohort no.5|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.~humanized monoclonal antibody against human IL-17"
8431|NCT02380287|P4|Participant Flow|Cohort no.4|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.~humanized monoclonal antibody against human IL-17"
8432|NCT02380287|P3|Participant Flow|Cohort no.3|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.~humanized monoclonal antibody against human IL-17"
8433|NCT02380287|P2|Participant Flow|Cohort no.2|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.~humanized monoclonal antibody against human IL-17"
8434|NCT02380287|P1|Participant Flow|Cohort no.1|"This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.~humanized monoclonal antibody against human IL-17"
8435|NCT02380287|O1|Outcome|BCD-085|This cohort includes subjects who received any dose of BCD-085 subcutaneously.
8436|NCT02380287|E8|Reported Event|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
8437|NCT02380287|E7|Reported Event|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
8438|NCT02380287|E6|Reported Event|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
8439|NCT02380287|E5|Reported Event|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
8440|NCT02380287|E4|Reported Event|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
8441|NCT02380287|E3|Reported Event|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
8442|NCT02380287|E2|Reported Event|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
8443|NCT02380287|E1|Reported Event|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
8444|NCT02380261|B1|Baseline|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
8445|NCT02380261|P1|Participant Flow|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
8447|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
8448|NCT02380261|E1|Reported Event|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
8449|NCT02379637|B3|Baseline|Total|Total of all reporting groups
8450|NCT02379637|B2|Baseline|B Placebo|"Placebo~Placebo"
8451|NCT02379637|B1|Baseline|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
8452|NCT02379637|P2|Participant Flow|B Placebo|"Placebo~Placebo, matching capsules three times daily"
8453|NCT02379637|P1|Participant Flow|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine, capsules, 800 mg 3 times daily"
8454|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
8455|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
8456|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
8457|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
8458|NCT02379637|E2|Reported Event|B Placebo|"Placebo~Placebo"
8459|NCT02379637|E1|Reported Event|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
8460|NCT02376998|B1|Baseline|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
8461|NCT02376998|P1|Participant Flow|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
8462|NCT02376998|O1|Outcome|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
8463|NCT02376998|E1|Reported Event|Valiant™ Endoluminal Procedure|"Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.~Valiant™ endoluminal procedure: Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:~The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.~After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
8464|NCT02375373|B1|Baseline|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
8465|NCT02375373|P1|Participant Flow|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
8466|NCT02375373|O1|Outcome|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
8467|NCT02375373|E1|Reported Event|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
8468|NCT02375347|B1|Baseline|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
8469|NCT02375347|P1|Participant Flow|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
8470|NCT02375347|O1|Outcome|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
8471|NCT02375347|E1|Reported Event|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
8472|NCT02374398|B5|Baseline|Total|Total of all reporting groups
8473|NCT02374398|B4|Baseline|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8474|NCT02374398|B3|Baseline|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8475|NCT02374398|B2|Baseline|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8476|NCT02374398|B1|Baseline|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8477|NCT02374398|P4|Participant Flow|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8478|NCT02374398|P3|Participant Flow|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8479|NCT02374398|P2|Participant Flow|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8480|NCT02374398|P1|Participant Flow|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8481|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8482|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8483|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8484|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8485|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control: Standard Electro-cautery and Saline"
8486|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8487|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8488|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8489|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8490|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8491|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8492|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8493|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8494|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8495|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8496|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8497|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8498|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8499|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8500|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8501|NCT02374398|E4|Reported Event|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
8502|NCT02374398|E3|Reported Event|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
8503|NCT02374398|E2|Reported Event|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
8504|NCT02374398|E1|Reported Event|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
8505|NCT02374346|B1|Baseline|Elective Surgery Patients|All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
8506|NCT02374346|P1|Participant Flow|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
8507|NCT02374346|O2|Outcome|Postoperative Headache Patients Without Headache History|Factors for developing postoperative headache in patients without previous history of headache.
8508|NCT02374346|O1|Outcome|Postoperative Headache in the Total Sample|Factors for developing postoperative headache in the total number of participants
8509|NCT02374346|O1|Outcome|Elective Surgery Patients (Total Sample)|postoperative headache in elective surgery patients
8510|NCT02374346|E1|Reported Event|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
8511|NCT02374164|B4|Baseline|Total|Total of all reporting groups
8512|NCT02374164|B3|Baseline|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
8513|NCT02374164|B2|Baseline|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
8514|NCT02374164|B1|Baseline|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
8515|NCT02374164|P3|Participant Flow|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
8516|NCT02374164|P2|Participant Flow|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
8517|NCT02374164|P1|Participant Flow|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
8518|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8519|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
9333|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
8520|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8521|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
8522|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8523|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8524|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8525|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
8526|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8527|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8528|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8529|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
8530|NCT02374164|E3|Reported Event|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8531|NCT02374164|E2|Reported Event|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
8532|NCT02374164|E1|Reported Event|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
8533|NCT02372344|B1|Baseline|AZD0585|All subjects received a single oral dose of 4 g AZD0585 on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. Each dose was administered on Day 1 of each separate treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
8534|NCT02372344|P3|Participant Flow|Sequence CAB|"Subjects randomized to treatment sequence CAB: C=after meal / A=fasting / B=before meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
8535|NCT02372344|P2|Participant Flow|Sequence BCA|"Subjects randomized to treatment sequence BCA: B=before meal / C=after meal / A=fasting.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
8536|NCT02372344|P1|Participant Flow|Sequence ABC|"Subjects randomized to treatment sequence ABC: A=fasting / B=before meal / C=after meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
8537|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
8538|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
8539|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
8540|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
8541|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
8542|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
8543|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
8544|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
8545|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
8546|NCT02372344|E3|Reported Event|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
8547|NCT02372344|E2|Reported Event|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
8548|NCT02372344|E1|Reported Event|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
8549|NCT02372097|B3|Baseline|Total|Total of all reporting groups
8550|NCT02372097|B2|Baseline|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
9334|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
8551|NCT02372097|B1|Baseline|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
8552|NCT02372097|P2|Participant Flow|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
8553|NCT02372097|P1|Participant Flow|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
8554|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8555|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8556|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8557|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8558|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8559|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8560|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8561|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8562|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8563|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8564|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8565|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8566|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8567|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8568|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8569|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8570|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8571|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8572|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8573|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8574|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8575|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8576|NCT02372097|E2|Reported Event|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8577|NCT02372097|E1|Reported Event|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
8578|NCT02372071|B1|Baseline|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
8579|NCT02372071|P1|Participant Flow|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
8580|NCT02372071|O2|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured routinely for total serum bilirubin
8581|NCT02372071|O1|Outcome|BiliCare TcB Average|"The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
8582|NCT02372071|E1|Reported Event|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
8583|NCT02372058|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
8584|NCT02372058|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
9335|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
9484|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
8585|NCT02372058|O3|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
8586|NCT02372058|O2|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
8587|NCT02372058|O1|Outcome|BiliCare TcB Average|"The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
8588|NCT02372058|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
8589|NCT02371876|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
8590|NCT02371876|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
8591|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
8592|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
8593|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
8594|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject venous blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. BG results were compared to reference method results obtained from subject venous plasma."
8595|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
8596|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary palm blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
8597|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
8598|NCT02371876|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
8599|NCT02370121|B3|Baseline|Total|Total of all reporting groups
8600|NCT02370121|B2|Baseline|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8601|NCT02370121|B1|Baseline|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
9336|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
9337|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
8602|NCT02370121|P2|Participant Flow|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8603|NCT02370121|P1|Participant Flow|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8604|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8605|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8606|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8607|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8608|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8609|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8610|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8611|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8612|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8613|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8614|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8615|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8616|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8617|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8618|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8619|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8620|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8621|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8622|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8623|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8624|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8710|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8625|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8626|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8627|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8628|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8629|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8630|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8631|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8632|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8633|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8634|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8635|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8636|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8637|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8638|NCT02370121|E2|Reported Event|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8639|NCT02370121|E1|Reported Event|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
8640|NCT02370615|B3|Baseline|Total|Total of all reporting groups
8641|NCT02370615|B2|Baseline|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once on Day 3 to 8.
8642|NCT02370615|B1|Baseline|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8643|NCT02370615|P2|Participant Flow|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8644|NCT02370615|P1|Participant Flow|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8645|NCT02370615|O1|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8646|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8647|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8648|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8649|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8650|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8651|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8652|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8653|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8654|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8655|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8656|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8657|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
8658|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8659|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
8660|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8661|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
8662|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8663|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
8664|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8665|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
8666|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8667|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
8668|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8669|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
8670|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8671|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
8672|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8673|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
8674|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8675|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
8676|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8677|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
8678|NCT02370615|E2|Reported Event|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
8679|NCT02370615|E1|Reported Event|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
8680|NCT02370602|B7|Baseline|Total|Total of all reporting groups
8681|NCT02370602|B6|Baseline|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8682|NCT02370602|B5|Baseline|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8683|NCT02370602|B4|Baseline|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8684|NCT02370602|B3|Baseline|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8685|NCT02370602|B2|Baseline|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8686|NCT02370602|B1|Baseline|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
9338|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
8687|NCT02370602|P6|Participant Flow|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8688|NCT02370602|P5|Participant Flow|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8689|NCT02370602|P4|Participant Flow|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8690|NCT02370602|P3|Participant Flow|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8691|NCT02370602|P2|Participant Flow|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8692|NCT02370602|P1|Participant Flow|[^11C]T-773 Only|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8693|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8694|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8695|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8696|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8697|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8698|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8699|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8700|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8701|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8702|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8703|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8704|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8705|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8706|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8707|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8708|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8709|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
9339|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
8711|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8712|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8713|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8714|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8715|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8716|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8717|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8718|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8719|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8720|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8721|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8722|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8723|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8724|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8725|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8726|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8727|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8728|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8729|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8730|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8731|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8732|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8733|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
9485|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
8734|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8735|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8736|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8737|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8738|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8739|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8740|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8741|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8742|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8743|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8744|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8745|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8746|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8747|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8748|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8749|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8750|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8751|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8752|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8753|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8754|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8755|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8756|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8757|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
9340|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
8758|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8759|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8760|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8761|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8762|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8763|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8764|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8765|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8766|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8767|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8768|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8769|NCT02370602|O2|Outcome|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
8770|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8771|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8772|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8773|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8774|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8775|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
8776|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8777|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
8778|NCT02370602|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8779|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
8780|NCT02370602|E2|Reported Event|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
8781|NCT02370602|E1|Reported Event|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
8782|NCT02370537|B4|Baseline|Total|Total of all reporting groups
8783|NCT02370537|B3|Baseline|Normal FEC (EPANOVA® and OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
8784|NCT02370537|B2|Baseline|Intermediate FEC (EPANOVA® and OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
8785|NCT02370537|B1|Baseline|Low FEC (EPANOVA® and OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
8786|NCT02370537|P3|Participant Flow|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8787|NCT02370537|P2|Participant Flow|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8788|NCT02370537|P1|Participant Flow|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels <100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8789|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8790|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8791|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8792|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8793|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8794|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8795|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8796|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8797|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8798|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8799|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8800|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
9341|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
8801|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8802|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8803|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8804|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8805|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8806|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8807|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8808|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8809|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8810|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8811|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8812|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8813|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8814|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8815|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8816|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8836|NCT02369341|B1|Baseline|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8817|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8818|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8819|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8820|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8821|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8822|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8823|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8824|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
8825|NCT02370537|O3|Outcome|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
8826|NCT02370537|O2|Outcome|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
8827|NCT02370537|O1|Outcome|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels <100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
8828|NCT02370537|E6|Reported Event|Normal FEC (OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
8829|NCT02370537|E5|Reported Event|Normal FEC (EPANOVA®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
8830|NCT02370537|E4|Reported Event|Intermediate FEC (OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
8831|NCT02370537|E3|Reported Event|Intermediate FEC (EPANOVA®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
8832|NCT02370537|E2|Reported Event|Low FEC (OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
8833|NCT02370537|E1|Reported Event|Low FEC (EPANOVA®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
8834|NCT02369341|B3|Baseline|Total|Total of all reporting groups
8835|NCT02369341|B2|Baseline|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8837|NCT02369341|P2|Participant Flow|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8838|NCT02369341|P1|Participant Flow|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8839|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8840|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8841|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8842|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8843|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8844|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8845|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8846|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8847|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8848|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8849|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8850|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8851|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8852|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8853|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8854|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8855|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8856|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8857|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8858|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8859|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8860|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8861|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
9486|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
8862|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8863|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8864|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8865|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8866|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8867|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8868|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8869|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8870|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8871|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8872|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8873|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8874|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8875|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
8876|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
8877|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8878|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8879|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8880|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8881|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8882|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8883|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8884|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8885|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
9487|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
8886|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8887|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8888|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8889|NCT02369341|E2|Reported Event|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8890|NCT02369341|E1|Reported Event|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
8891|NCT02368457|B3|Baseline|Total|Total of all reporting groups
8892|NCT02368457|B2|Baseline|Control Group|No drug treatment
8893|NCT02368457|B1|Baseline|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
8894|NCT02368457|P2|Participant Flow|Control Group|No drug treatment
8895|NCT02368457|P1|Participant Flow|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
8896|NCT02368457|O2|Outcome|CONTROL|No drug treatment
8897|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
8898|NCT02368457|O2|Outcome|Control Group|Standard treatment
8899|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
8900|NCT02368457|E2|Reported Event|Control Group|Standard treatment
8901|NCT02368457|E1|Reported Event|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
8902|NCT02368314|B3|Baseline|Total|Total of all reporting groups
8903|NCT02368314|B2|Baseline|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8904|NCT02368314|B1|Baseline|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8905|NCT02368314|P2|Participant Flow|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8906|NCT02368314|P1|Participant Flow|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8907|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8908|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8909|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8910|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8911|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
9036|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9037|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
8912|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8913|NCT02368314|E2|Reported Event|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8914|NCT02368314|E1|Reported Event|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
8915|NCT02368093|B3|Baseline|Total|Total of all reporting groups
8916|NCT02368093|B2|Baseline|Placebo|Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
8917|NCT02368093|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months
8918|NCT02368093|P2|Participant Flow|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
8919|NCT02368093|P1|Participant Flow|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
8920|NCT02368093|O2|Outcome|Placebo|placebo pills with the same appearance as Detosiv tablets.
8921|NCT02368093|O1|Outcome|Dextromethorphan Hydrobromide|"Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]~Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months"
8922|NCT02368093|E2|Reported Event|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
8923|NCT02368093|E1|Reported Event|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
8924|NCT02367885|B4|Baseline|Total|Total of all reporting groups
8925|NCT02367885|B3|Baseline|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8926|NCT02367885|B2|Baseline|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8927|NCT02367885|B1|Baseline|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8928|NCT02367885|P3|Participant Flow|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8929|NCT02367885|P2|Participant Flow|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8930|NCT02367885|P1|Participant Flow|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8931|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8932|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8933|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8934|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8935|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8936|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8937|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8938|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8939|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8940|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
9038|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 infusion)
9039|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
8941|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8942|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8943|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8944|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8945|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8946|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8947|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8948|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8949|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8950|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8951|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8952|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8953|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8954|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8955|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8956|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8957|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8958|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8959|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8960|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8961|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8962|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8963|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8964|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8965|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8966|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8967|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8968|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8969|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
9040|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded glucose and GLP1 infusion)
8970|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8971|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8972|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8973|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8974|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8975|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8976|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8977|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8978|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8979|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8980|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8981|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8982|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8983|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8984|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8985|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8986|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8987|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8988|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8989|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8990|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8991|NCT02367885|E3|Reported Event|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
8992|NCT02367885|E2|Reported Event|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8993|NCT02367885|E1|Reported Event|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
8994|NCT02367170|B3|Baseline|Total|Total of all reporting groups
8995|NCT02367170|B2|Baseline|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
8996|NCT02367170|B1|Baseline|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
9041|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9042|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9043|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9044|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9045|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
8997|NCT02367170|P2|Participant Flow|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
8998|NCT02367170|P1|Participant Flow|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
8999|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
9000|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
9001|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
9002|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
9003|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
9004|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
9005|NCT02367170|E2|Reported Event|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
9006|NCT02367170|E1|Reported Event|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
9007|NCT02367066|B3|Baseline|Total|Total of all reporting groups
9008|NCT02367066|B2|Baseline|Placebo-AZD1981|Sequence Placebo-AZD1981
9009|NCT02367066|B1|Baseline|AZD1981-Placebo|Sequence AZD1981-Placebo
9010|NCT02367066|P2|Participant Flow|Placebo-AZD1981|Sequence Placebo-AZD1981
9011|NCT02367066|P1|Participant Flow|AZD1981-Placebo|Sequence AZD1981-Placebo
9012|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9013|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9014|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9015|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9016|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9017|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9018|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9019|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9020|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9021|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9022|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9023|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9024|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9025|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9026|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9027|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9028|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9029|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
9030|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9031|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9032|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9033|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
9034|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
9035|NCT02367066|O1|Outcome|MMTT|Mixed Meal Tolerance Test (MMTT)
9046|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
9068|NCT02366923|B1|Baseline|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
9069|NCT02366923|P1|Participant Flow|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
9070|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9071|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9072|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9073|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9074|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9075|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9076|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9077|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9078|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9079|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9080|NCT02366923|E1|Reported Event|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
9081|NCT02366910|B1|Baseline|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9082|NCT02366910|P1|Participant Flow|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9083|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9084|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9085|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9086|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9087|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9088|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9089|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9090|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9091|NCT02366910|E2|Reported Event|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9092|NCT02366910|E1|Reported Event|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
9093|NCT02366767|B3|Baseline|Total|Total of all reporting groups
9094|NCT02366767|B2|Baseline|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9095|NCT02366767|B1|Baseline|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9096|NCT02366767|P2|Participant Flow|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9097|NCT02366767|P1|Participant Flow|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9098|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9099|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9100|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9101|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9102|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9103|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9104|NCT02366767|E2|Reported Event|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
9105|NCT02366767|E1|Reported Event|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
9106|NCT02366689|B4|Baseline|Total|Total of all reporting groups
9107|NCT02366689|B3|Baseline|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9108|NCT02366689|B2|Baseline|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9109|NCT02366689|B1|Baseline|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9110|NCT02366689|P3|Participant Flow|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9111|NCT02366689|P2|Participant Flow|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9112|NCT02366689|P1|Participant Flow|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9130|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9342|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
9488|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9113|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9114|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9115|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9116|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9117|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9118|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9119|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9120|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9121|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9122|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9123|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9124|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9125|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9126|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9127|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9128|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9129|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9131|NCT02366689|E3|Reported Event|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
9132|NCT02366689|E2|Reported Event|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
9133|NCT02366689|E1|Reported Event|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
9134|NCT02366637|B1|Baseline|All Participants|All participants who received at least 1 dose of study drug (PF-03715455 or placebo).
9135|NCT02366637|P2|Participant Flow|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9136|NCT02366637|P1|Participant Flow|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9137|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9138|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9139|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9140|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9141|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9142|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9143|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9144|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9145|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9146|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9147|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9148|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9149|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9150|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9151|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9152|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9153|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9154|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9328|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
9155|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9156|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9157|NCT02366637|E2|Reported Event|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9158|NCT02366637|E1|Reported Event|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
9159|NCT02366338|B4|Baseline|Total|Total of all reporting groups
9160|NCT02366338|B3|Baseline|Group 3|Patients on dabigatran therapy
9161|NCT02366338|B2|Baseline|Group 2|patients on rivaroxaban therapy
9162|NCT02366338|B1|Baseline|Group 1|patients on warfarin therapy
9163|NCT02366338|P3|Participant Flow|Group 3|Patients on dabigatran therapy
9164|NCT02366338|P2|Participant Flow|Group 2|patients on rivaroxaban therapy
9165|NCT02366338|P1|Participant Flow|Group 1|patients on warfarin therapy
9166|NCT02366338|O3|Outcome|Group 3|Patients on dabigatran therapy
9167|NCT02366338|O2|Outcome|Group 2|patients on rivaroxaban therapy
9168|NCT02366338|O1|Outcome|Group 1|patients on warfarin therapy
9169|NCT02366338|E3|Reported Event|Group 3|Patients on dabigatran therapy
9170|NCT02366338|E2|Reported Event|Group 2|patients on rivaroxaban therapy
9171|NCT02366338|E1|Reported Event|Group 1|patients on warfarin therapy
9172|NCT02365688|B1|Baseline|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
9173|NCT02365688|P1|Participant Flow|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
9174|NCT02365688|O1|Outcome|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
9175|NCT02365688|E1|Reported Event|Pre-surgical Bolus|Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
9176|NCT02364778|B3|Baseline|Total|Total of all reporting groups
9177|NCT02364778|B2|Baseline|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9178|NCT02364778|B1|Baseline|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9179|NCT02364778|P1|Participant Flow|Provisional Stenting Strategy|Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
9180|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9181|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9182|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9183|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9184|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9185|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9186|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9187|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9188|NCT02364778|E2|Reported Event|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
9189|NCT02364778|E1|Reported Event|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
9190|NCT02363478|B1|Baseline|Buspirone|22 out of 30 participants (19 female) completed the study.
9191|NCT02363478|P1|Participant Flow|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
9192|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
9193|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
9194|NCT02363478|O1|Outcome|Buspirone|"4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement~buspirone: buspirone 10 mg X2 for 4 weeks"
9195|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
9196|NCT02363478|E1|Reported Event|Buspirone|Participants received bouspirone 20 mg/day for 4 weeks
9197|NCT02362373|B1|Baseline|Levonorgestrel IUS|"all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.~levonorgestrel IUS: placement of levonorgestrel intrauterine system"
9198|NCT02362373|P1|Participant Flow|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9199|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9200|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9201|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9202|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9203|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9204|NCT02362373|E1|Reported Event|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
9205|NCT02362360|B1|Baseline|Overall Study Population|All subjects included in the investigation
9206|NCT02362360|P2|Participant Flow|Comparator Then Coloplast Test Product|"The subject first tests the Comparator and then tests the Coloplast Test Product.~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
9207|NCT02362360|P1|Participant Flow|Coloplast Test Product Then Comparator|"The subject first tests the Coloplast Test Product and then tests the Comparator~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
9208|NCT02362360|O2|Outcome|Comparator|Answers from subjects testing Comparator
9209|NCT02362360|O1|Outcome|Coloplast Test Product|Answers from subjects testing Coloplast test product
9210|NCT02362360|E2|Reported Event|Comparator|Answers from subjects testing Comparator
9211|NCT02362360|E1|Reported Event|Coloplast Test Product|Answers from subjects testing Coloplast test product
9212|NCT02362321|B3|Baseline|Total|Total of all reporting groups
9213|NCT02362321|B2|Baseline|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
9214|NCT02362321|B1|Baseline|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
9215|NCT02362321|P2|Participant Flow|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
9216|NCT02362321|P1|Participant Flow|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
9217|NCT02362321|O2|Outcome|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
9218|NCT02362321|O1|Outcome|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
9219|NCT02362321|E2|Reported Event|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
9220|NCT02362321|E1|Reported Event|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
9221|NCT02361736|B3|Baseline|Total|Total of all reporting groups
9222|NCT02361736|B2|Baseline|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9223|NCT02361736|B1|Baseline|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9224|NCT02361736|P2|Participant Flow|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9225|NCT02361736|P1|Participant Flow|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9226|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9227|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9228|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9229|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9230|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9231|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9329|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
9232|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9233|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9234|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9235|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9236|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9237|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9238|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9239|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9240|NCT02361736|E2|Reported Event|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
9241|NCT02361736|E1|Reported Event|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
9242|NCT02360995|B4|Baseline|Total|Total of all reporting groups
9243|NCT02360995|B3|Baseline|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9244|NCT02360995|B2|Baseline|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9245|NCT02360995|B1|Baseline|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9246|NCT02360995|P3|Participant Flow|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9247|NCT02360995|P2|Participant Flow|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9248|NCT02360995|P1|Participant Flow|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9249|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9250|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9251|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9252|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9253|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9330|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
9254|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9255|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9256|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9257|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9258|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9259|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9260|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9261|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9262|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9263|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9264|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9265|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9266|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9267|NCT02360995|E3|Reported Event|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
9268|NCT02360995|E2|Reported Event|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
9269|NCT02360995|E1|Reported Event|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
9270|NCT02360124|B4|Baseline|Total|Total of all reporting groups
9271|NCT02360124|B3|Baseline|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9272|NCT02360124|B2|Baseline|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9273|NCT02360124|B1|Baseline|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
9384|NCT02358044|B3|Baseline|Total|Total of all reporting groups
9274|NCT02360124|P3|Participant Flow|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9275|NCT02360124|P2|Participant Flow|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9276|NCT02360124|P1|Participant Flow|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
9277|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces~saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces"
9278|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9279|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
9280|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9281|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9282|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
9283|NCT02360124|E3|Reported Event|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9284|NCT02360124|E2|Reported Event|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
9285|NCT02360124|E1|Reported Event|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
9286|NCT02359955|B3|Baseline|Total|Total of all reporting groups
9287|NCT02359955|B2|Baseline|Group 2|"edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
9331|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
9332|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
9444|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9288|NCT02359955|B1|Baseline|Group 1|"edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
9289|NCT02359955|P2|Participant Flow|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
9290|NCT02359955|P1|Participant Flow|Zero-degree Teeth, Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
9291|NCT02359955|O4|Outcome|Duration of Left Masseter of Anatomic Teeth|
9292|NCT02359955|O3|Outcome|Duration of Right Masster of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
9293|NCT02359955|O2|Outcome|Duration of Left Masseter of Zero Degree Teeth|
9294|NCT02359955|O1|Outcome|Duration of Right Masseter of Zero Degree Teeth|emg parameter of patients treated with zero degree teeth
9295|NCT02359955|O4|Outcome|Amp Value of Left Masseter of Anatomic Teeth|
9296|NCT02359955|O3|Outcome|Amp Value of Right Master of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
9297|NCT02359955|O2|Outcome|Amp Value of Left Masseter of Zero Degree Teeth|
9298|NCT02359955|O1|Outcome|Amp Value of Right Masseter of Zero Degree Teeth|emg parameter of edentulous patients treated with zero-degree teeth complete denture
9299|NCT02359955|O4|Outcome|Group 2 Zero Degree Teeth|
9300|NCT02359955|O3|Outcome|Group 1 Anatomic Teeth|
9301|NCT02359955|O2|Outcome|Group 2 Anatomic Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
9302|NCT02359955|O1|Outcome|Group 1 Zero Degree Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
9303|NCT02359955|E2|Reported Event|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
9304|NCT02359955|E1|Reported Event|Zero Degree Teeth,Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
9305|NCT02359903|B3|Baseline|Total|Total of all reporting groups
9306|NCT02359903|B2|Baseline|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
9307|NCT02359903|B1|Baseline|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
9308|NCT02359903|P2|Participant Flow|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
9309|NCT02359903|P1|Participant Flow|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
9310|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
9311|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
9312|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
9313|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
9314|NCT02359903|E2|Reported Event|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
9315|NCT02359903|E1|Reported Event|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
9316|NCT02359877|B4|Baseline|Total|Total of all reporting groups
9317|NCT02359877|B3|Baseline|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
9318|NCT02359877|B2|Baseline|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
9319|NCT02359877|B1|Baseline|BCD-054|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; OR 120 mcg, IM/SC; OR 240 mcg, IM/SC; OR 360 mcg, IM/SC OR multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
9320|NCT02359877|P3|Participant Flow|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
9321|NCT02359877|P2|Participant Flow|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
9322|NCT02359877|P1|Participant Flow|BCD-054|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; OR 120 mcg, IM/SC; OR 240 mcg, IM/SC; OR 360 mcg, IM/SC OR multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
9323|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
9324|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
9325|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
9326|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
9327|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
9445|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9343|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
9344|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
9345|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
9346|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
9347|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
9348|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
9349|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
9350|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
9351|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
9352|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
9353|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
9354|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
9355|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
9356|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
9357|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
9358|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
9359|NCT02359877|E12|Reported Event|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
9360|NCT02359877|E11|Reported Event|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
9361|NCT02359877|E10|Reported Event|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
9362|NCT02359877|E9|Reported Event|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
9363|NCT02359877|E8|Reported Event|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
9364|NCT02359877|E7|Reported Event|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
9365|NCT02359877|E6|Reported Event|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
9366|NCT02359877|E5|Reported Event|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
9367|NCT02359877|E4|Reported Event|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
9368|NCT02359877|E3|Reported Event|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
9369|NCT02359877|E2|Reported Event|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
9370|NCT02359877|E1|Reported Event|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
9371|NCT02359435|B3|Baseline|Total|Total of all reporting groups
9372|NCT02359435|B2|Baseline|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
9373|NCT02359435|B1|Baseline|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
9374|NCT02359435|P2|Participant Flow|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
9375|NCT02359435|P1|Participant Flow|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
9376|NCT02359435|O2|Outcome|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
9377|NCT02359435|O1|Outcome|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
9378|NCT02359435|E2|Reported Event|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
9379|NCT02359435|E1|Reported Event|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
9380|NCT02358876|B1|Baseline|Participants|
9381|NCT02358876|P1|Participant Flow|Participants|
9382|NCT02358876|O1|Outcome|Participants|
9383|NCT02358876|E1|Reported Event|Participants|
9385|NCT02358044|B2|Baseline|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9386|NCT02358044|B1|Baseline|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9387|NCT02358044|P2|Participant Flow|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9388|NCT02358044|P1|Participant Flow|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9389|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9390|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9391|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9392|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9393|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9394|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9395|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9396|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9397|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9398|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9399|NCT02358044|E2|Reported Event|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
9400|NCT02358044|E1|Reported Event|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
9401|NCT02357940|B3|Baseline|Total|Total of all reporting groups
9402|NCT02357940|B2|Baseline|Babies|Babies - 1% Colloidal Oatmeal Balm
9403|NCT02357940|B1|Baseline|Adults|Adults - 1% Colloidal Oatmeal Balm
9404|NCT02357940|P2|Participant Flow|Babies|Babies - 1% Colloidal Oatmeal Balm
9405|NCT02357940|P1|Participant Flow|Adults|Adults - 1% Colloidal Oatmeal Balm
9406|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9407|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9408|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9409|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9410|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9411|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9412|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9413|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9414|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9415|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9416|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9417|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9418|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9419|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9420|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9421|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9422|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9423|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9424|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9425|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9426|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9427|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9428|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9429|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9430|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9431|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9432|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9433|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9434|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9435|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9436|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9437|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9438|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9439|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9440|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9441|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9442|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9443|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9489|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9490|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9491|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9492|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9493|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9494|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9495|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9496|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9497|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9498|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9499|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9500|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9501|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9502|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9503|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9504|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9505|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9506|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9507|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9508|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9509|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9510|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9511|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9512|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9513|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9514|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9515|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9516|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9517|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9518|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9519|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9520|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9521|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9522|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9523|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9524|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
9525|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
9526|NCT02357940|E2|Reported Event|Babies|Babies - 1% Colloidal Oatmeal Balm
9527|NCT02357940|E1|Reported Event|Adults|Adults - 1% Colloidal Oatmeal Balm
9528|NCT02357485|B1|Baseline|Treatment Arm|Single injection of ADSC
9529|NCT02357485|P1|Participant Flow|Treatment Arm|Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
9530|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
9531|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
9532|NCT02357485|O1|Outcome|Treatment Arm|"Single injection of ADSC~ADSC: Single injection of ADSC"
9533|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
9534|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
9535|NCT02357485|E1|Reported Event|Treatment Arm|Single injection of ADSC
9536|NCT02356588|B3|Baseline|Total|Total of all reporting groups
9537|NCT02356588|B2|Baseline|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9538|NCT02356588|B1|Baseline|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9539|NCT02356588|P2|Participant Flow|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9540|NCT02356588|P1|Participant Flow|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9541|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9600|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
9601|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
10876|NCT02325856|B3|Baseline|Total|Total of all reporting groups
9542|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9543|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9544|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9545|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9546|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9547|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9548|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9549|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9550|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9551|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9552|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9553|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9554|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9555|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9602|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
11870|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
9556|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9557|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9558|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9559|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9560|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9561|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9562|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9563|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9564|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9565|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9566|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9567|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9568|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9569|NCT02356588|E2|Reported Event|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
9603|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
11871|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
9570|NCT02356588|E1|Reported Event|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
9571|NCT02355977|B4|Baseline|Total|Total of all reporting groups
9572|NCT02355977|B3|Baseline|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9573|NCT02355977|B2|Baseline|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9574|NCT02355977|B1|Baseline|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9575|NCT02355977|P3|Participant Flow|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9576|NCT02355977|P2|Participant Flow|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9577|NCT02355977|P1|Participant Flow|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9578|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9579|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9580|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9581|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9582|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9583|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9584|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9585|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9586|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9587|NCT02355977|E3|Reported Event|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
9588|NCT02355977|E2|Reported Event|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
9589|NCT02355977|E1|Reported Event|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
9590|NCT02355275|B1|Baseline|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
9591|NCT02355275|P1|Participant Flow|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
9592|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
9593|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
9594|NCT02355275|E1|Reported Event|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
9595|NCT02354833|B3|Baseline|Total|Total of all reporting groups
9596|NCT02354833|B2|Baseline|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
9597|NCT02354833|B1|Baseline|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
9598|NCT02354833|P2|Participant Flow|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
9599|NCT02354833|P1|Participant Flow|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
9604|NCT02354833|O2|Outcome|Norepinephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
9605|NCT02354833|O1|Outcome|Phenylephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
9606|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
9607|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
9608|NCT02354833|E2|Reported Event|Norepinephrine|Hypotension requiring a rescue bolus
9609|NCT02354833|E1|Reported Event|Phenylephrine|Hypotension requiring a rescue bolus
9610|NCT02354599|B7|Baseline|Total|Total of all reporting groups
9611|NCT02354599|B6|Baseline|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9612|NCT02354599|B5|Baseline|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9613|NCT02354599|B4|Baseline|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9614|NCT02354599|B3|Baseline|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9615|NCT02354599|B2|Baseline|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9616|NCT02354599|B1|Baseline|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9617|NCT02354599|P6|Participant Flow|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9618|NCT02354599|P5|Participant Flow|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9619|NCT02354599|P4|Participant Flow|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9620|NCT02354599|P3|Participant Flow|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9621|NCT02354599|P2|Participant Flow|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9622|NCT02354599|P1|Participant Flow|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9623|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9624|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9625|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9626|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9627|NCT02354599|O6|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9628|NCT02354599|O5|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9629|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9630|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9631|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9632|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9633|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9634|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9635|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9636|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9637|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9638|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9639|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9640|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9641|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9642|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9643|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9644|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9645|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9646|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
11872|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
9647|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9648|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9649|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9650|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9651|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9652|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9653|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9654|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9655|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9656|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9657|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9658|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9659|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9660|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9661|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9662|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9663|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9664|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9665|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9666|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9667|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9668|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9669|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9670|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9671|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9672|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9673|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9674|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9675|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9676|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9677|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9678|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9679|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9680|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9681|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9682|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9683|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9684|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9685|NCT02354599|E6|Reported Event|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9686|NCT02354599|E5|Reported Event|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
9687|NCT02354599|E4|Reported Event|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9688|NCT02354599|E3|Reported Event|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9689|NCT02354599|E2|Reported Event|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9690|NCT02354599|E1|Reported Event|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
9691|NCT02353754|B3|Baseline|Total|Total of all reporting groups
9692|NCT02353754|B2|Baseline|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9693|NCT02353754|B1|Baseline|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9694|NCT02353754|P2|Participant Flow|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9695|NCT02353754|P1|Participant Flow|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9696|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9697|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9698|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9699|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9700|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9701|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9702|NCT02353754|E2|Reported Event|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
9703|NCT02353754|E1|Reported Event|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
9704|NCT02353572|B1|Baseline|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
9705|NCT02353572|P1|Participant Flow|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
9706|NCT02353572|O1|Outcome|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
9707|NCT02353572|E1|Reported Event|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
9708|NCT02353468|B1|Baseline|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
9724|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9725|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9709|NCT02353468|P1|Participant Flow|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
9710|NCT02353468|O1|Outcome|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
9711|NCT02353468|E1|Reported Event|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
9712|NCT02353442|B3|Baseline|Total|Total of all reporting groups
9713|NCT02353442|B2|Baseline|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9714|NCT02353442|B1|Baseline|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9715|NCT02353442|P2|Participant Flow|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9716|NCT02353442|P1|Participant Flow|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9717|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9718|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9719|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9720|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9721|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9722|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9723|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9768|NCT02350881|O2|Outcome|Presence|Number of feet where osteolysis was observed
9769|NCT02350881|O1|Outcome|Absence|Number of feet where no osteolysis was observed
9770|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
9726|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9727|NCT02353442|E2|Reported Event|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9728|NCT02353442|E1|Reported Event|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
9729|NCT02351817|B1|Baseline|Overall Study Population|The investigation is a cross-over investigation therefore baseline data is presented for the overall population
9730|NCT02351817|P2|Participant Flow|Baseline - Test B - Test A|"First each subject tests baseline product, then Test B and finally Test A.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
9731|NCT02351817|P1|Participant Flow|Baseline - Test A - Test B|"First each subject tests baseline product, then Test A and finally Test B.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
9732|NCT02351817|O2|Outcome|Test B|How many subjects preferred Test B over own product
9733|NCT02351817|O1|Outcome|Test A|How many subjects preferred Test A over own product
9734|NCT02351817|E3|Reported Event|Test B|Adverse events reported by subjects testing Test B
9735|NCT02351817|E2|Reported Event|Test A|Adverse events reported by subjects testing Test A
9736|NCT02351817|E1|Reported Event|Baseline|Adverse events reported by subjects testing Own product
9737|NCT02351505|B1|Baseline|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9738|NCT02351505|P1|Participant Flow|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
9739|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9740|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9741|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9742|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9743|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9744|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9745|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9746|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
9747|NCT02351505|E1|Reported Event|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
9748|NCT02350881|B1|Baseline|Overall Cohort|one consecutive series of patients were included
9749|NCT02350881|P1|Participant Flow|Overall Cohort|one consecutive series of patients were included
9750|NCT02350881|O2|Outcome|Revisions|Percentage of feet reoperated for implant ablation
9751|NCT02350881|O1|Outcome|Survival|Percentage of feet with implant still in place
9752|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain at rest postoperatively
9753|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain at rest postoperatively
9754|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain at rest postoperatively
9755|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain at rest postoperatively
9756|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain during walking postoperatively
9757|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain during walking postoperatively
9758|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain during walking postoperatively
9759|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain during walking postoperatively
9760|NCT02350881|O3|Outcome|Worsened|Number of patients who declared a worsening of their walking perimeter
9761|NCT02350881|O2|Outcome|Same|Number of patients who declared no improvement in their walking perimeter
9762|NCT02350881|O1|Outcome|Improved|Number of patients who declared an improvement in their walking perimeter
9763|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
9764|NCT02350881|O2|Outcome|Moderate|umber of patients reporting a moderate pain
9765|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
9766|NCT02350881|O2|Outcome|Presence|Number of feet where bone resorption was observed
9767|NCT02350881|O1|Outcome|Absence|Number of feet where no bone resorption was observed
9771|NCT02350881|O2|Outcome|Moderate|Number of patients reporting a moderate pain
9772|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
9773|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
9774|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
9775|NCT02350881|E1|Reported Event|Overall Cohort|one consecutive series of patients were included
9776|NCT02349711|B3|Baseline|Total|Total of all reporting groups
9777|NCT02349711|B2|Baseline|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9778|NCT02349711|B1|Baseline|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9779|NCT02349711|P2|Participant Flow|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9780|NCT02349711|P1|Participant Flow|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9781|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9782|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9783|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9784|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9785|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9786|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9787|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9788|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9789|NCT02349711|E2|Reported Event|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
9790|NCT02349711|E1|Reported Event|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
9791|NCT02349685|B4|Baseline|Total|Total of all reporting groups
9792|NCT02349685|B3|Baseline|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
9793|NCT02349685|B2|Baseline|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
9794|NCT02349685|B1|Baseline|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
9795|NCT02349685|P3|Participant Flow|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
9796|NCT02349685|P2|Participant Flow|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
10303|NCT02335710|P2|Participant Flow|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
9797|NCT02349685|P1|Participant Flow|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
9798|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
9799|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
9800|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
9801|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
9802|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
9803|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
9804|NCT02349685|E3|Reported Event|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
9805|NCT02349685|E2|Reported Event|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
9806|NCT02349685|E1|Reported Event|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
9807|NCT02349438|B1|Baseline|Dispensed|All subjects that were dispensed at least 1 study lens during the course of the study.
9808|NCT02349438|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
9809|NCT02349438|P1|Participant Flow|Senofilcon A/Lotrafilcon B|Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
9810|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
9811|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
9812|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
9813|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
9814|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
9815|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
9816|NCT02349438|E2|Reported Event|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
9817|NCT02349438|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
9854|NCT02347488|P1|Participant Flow|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
9818|NCT02348658|B1|Baseline|All Participants|All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
9819|NCT02348658|P2|Participant Flow|TAK-536TCH Fed + TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
9820|NCT02348658|P1|Participant Flow|TAK-536TCH Fasted + TAK-536TCH Fed|TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
9821|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9822|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9823|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9824|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9825|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9826|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9827|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9828|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9829|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9830|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9831|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9832|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9833|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9834|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9835|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9836|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9837|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9838|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9839|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9840|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9841|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9842|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9843|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9844|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9845|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9846|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9847|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9848|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9849|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9850|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9851|NCT02348658|E2|Reported Event|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
9852|NCT02348658|E1|Reported Event|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
9853|NCT02347488|B1|Baseline|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
9855|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9856|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9857|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9858|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9859|NCT02347488|O1|Outcome|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
9860|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9861|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
9862|NCT02347488|E1|Reported Event|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
9863|NCT02345720|B1|Baseline|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9864|NCT02345720|P1|Participant Flow|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9865|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9866|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9867|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9868|NCT02345720|E1|Reported Event|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
9869|NCT02344745|B3|Baseline|Total|Total of all reporting groups
9870|NCT02344745|B2|Baseline|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9871|NCT02344745|B1|Baseline|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9872|NCT02344745|P2|Participant Flow|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9873|NCT02344745|P1|Participant Flow|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9874|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9875|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9876|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9877|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9878|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9969|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10877|NCT02325856|B2|Baseline|Control Group|Dry weight determined by clinical symptoms
9879|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9880|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9881|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9882|NCT02344745|E2|Reported Event|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9883|NCT02344745|E1|Reported Event|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
9884|NCT02343380|B3|Baseline|Total|Total of all reporting groups
9885|NCT02343380|B2|Baseline|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9886|NCT02343380|B1|Baseline|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9887|NCT02343380|P2|Participant Flow|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9888|NCT02343380|P1|Participant Flow|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9889|NCT02343380|O2|Outcome|Evening|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9890|NCT02343380|O1|Outcome|Morning|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am.~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9891|NCT02343380|O2|Outcome|Evening|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
9892|NCT02343380|O1|Outcome|Morning|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
9893|NCT02343380|O2|Outcome|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9894|NCT02343380|O1|Outcome|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9895|NCT02343380|E2|Reported Event|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9896|NCT02343380|E1|Reported Event|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
9897|NCT02343081|B3|Baseline|Total|Total of all reporting groups
9898|NCT02343081|B2|Baseline|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
9970|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9971|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9899|NCT02343081|B1|Baseline|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
9900|NCT02343081|P2|Participant Flow|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
9901|NCT02343081|P1|Participant Flow|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
9902|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
9903|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
9904|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
9905|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
9906|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
9907|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
9908|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
9909|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
9910|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
9911|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
9912|NCT02343081|E2|Reported Event|Dralitem|Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose.
9913|NCT02343081|E1|Reported Event|Temodal|Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
9914|NCT02342561|B1|Baseline|Intervention Knees (Draped Knees) and Control Knees (No-draped|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The knee that is not drape is left uncovered during the intervention."
9915|NCT02342561|P1|Participant Flow|Intervention Knee (Drape Side) and Control Knee (No Drape Side|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The control knee that is not drape is left uncovered during the intervention."
9916|NCT02342561|O2|Outcome|Control Knees (No-drape Side)|The knees were not drape were left uncovered during the intervention.
9917|NCT02342561|O1|Outcome|Intervention Knees (Drape Side)|"One knee of the patient were randomly selected to be draped with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
9918|NCT02342561|O2|Outcome|Control Knee (No-drape Knees)|The knee that is not drape is left uncovered during the intervention.
9919|NCT02342561|O1|Outcome|Intervention Knee (Draped Knees)|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
9920|NCT02342561|E2|Reported Event|Control Knees|The knees that were not drape is left uncovered during the intervention.
9921|NCT02342561|E1|Reported Event|Intervention Knees|"One knee of the patient were randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
9922|NCT02342288|B3|Baseline|Total|Total of all reporting groups
9923|NCT02342288|B2|Baseline|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9924|NCT02342288|B1|Baseline|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9972|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9973|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9925|NCT02342288|P2|Participant Flow|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9926|NCT02342288|P1|Participant Flow|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9927|NCT02342288|O2|Outcome|Head in Neutral Position|"Head in neutral position~Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9928|NCT02342288|O1|Outcome|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9929|NCT02342288|E2|Reported Event|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9930|NCT02342288|E1|Reported Event|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
9931|NCT02342223|B1|Baseline|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9932|NCT02342223|P1|Participant Flow|Voluma Treatment of HIV Facial Lipoatrophy|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9933|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9934|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9935|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9936|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9937|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
10187|NCT02338336|P3|Participant Flow|Nowarta110 6 Drops|Nowarta110 6 drops administered topically
9938|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9939|NCT02342223|E1|Reported Event|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
9940|NCT02342197|B3|Baseline|Total|Total of all reporting groups
9941|NCT02342197|B2|Baseline|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
9942|NCT02342197|B1|Baseline|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
9943|NCT02342197|P2|Participant Flow|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
9944|NCT02342197|P1|Participant Flow|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
9945|NCT02342197|O2|Outcome|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
9946|NCT02342197|O1|Outcome|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
9947|NCT02342197|E2|Reported Event|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
9948|NCT02342197|E1|Reported Event|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
9949|NCT02341859|B1|Baseline|Overall Participant Flow|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
9950|NCT02341859|P2|Participant Flow|Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A|"Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens~delefilcon A: contact lens"
9951|NCT02341859|P1|Participant Flow|Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A|"Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
9952|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9953|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9954|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9955|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9956|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9957|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9958|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9959|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9960|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9961|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9962|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9963|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9964|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9965|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9966|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9967|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9968|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11873|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
9974|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9975|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9976|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9977|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9978|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9979|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9980|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9981|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9982|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9983|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9984|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9985|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9986|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9987|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9988|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
9989|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9990|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9991|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9992|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
9993|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9994|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9995|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9996|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
9997|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
9998|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
9999|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10000|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10001|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10002|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10003|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10004|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10005|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10006|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10007|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10008|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10009|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11874|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
10010|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10011|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10012|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10013|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10014|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10015|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10016|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10017|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10018|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10019|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10020|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10021|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10022|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10023|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10024|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10025|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10026|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10027|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10028|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10029|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10030|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10031|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10032|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10033|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10034|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10035|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10036|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10037|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10038|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10039|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10040|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10041|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10042|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10043|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10044|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10045|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
11875|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
10046|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10047|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10048|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10049|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10050|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10051|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10052|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10053|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10054|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10055|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10056|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10057|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10058|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10059|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10060|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10061|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10062|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10063|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10064|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10065|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10066|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10067|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10068|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10069|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10070|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10071|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10072|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10073|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10074|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10075|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10076|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10077|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10078|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10079|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10080|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10081|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
11876|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
10082|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10083|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10084|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10085|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10086|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10087|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10088|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10089|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10090|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10091|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10092|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10093|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10094|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10095|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10096|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
10097|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10098|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10099|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
10100|NCT02341859|E3|Reported Event|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
10101|NCT02341859|E2|Reported Event|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
10102|NCT02341859|E1|Reported Event|Stenfilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
10103|NCT02341482|B1|Baseline|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10104|NCT02341482|P1|Participant Flow|All Subjects|PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
10105|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10106|NCT02341482|O3|Outcome|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
10107|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10108|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10109|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10110|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10188|NCT02338336|P2|Participant Flow|Norwarta110 3 Drops|Nowarta110 3 drops administered topically
10189|NCT02338336|P1|Participant Flow|Placebo|Matching Placebo
10190|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
10191|NCT02338336|O1|Outcome|Placebo|Matching Placebo
10111|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10112|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10113|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
10114|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10115|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10116|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10117|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10118|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10119|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10120|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10121|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10122|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10123|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10124|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
10125|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10126|NCT02341482|E3|Reported Event|PF-04958242 0.025 mg Combined With Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
10127|NCT02341482|E2|Reported Event|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
10128|NCT02341482|E1|Reported Event|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
10129|NCT02340338|B8|Baseline|Total|Total of all reporting groups
10130|NCT02340338|B7|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10131|NCT02340338|B6|Baseline|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10132|NCT02340338|B5|Baseline|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10133|NCT02340338|B4|Baseline|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10192|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
10193|NCT02338336|O1|Outcome|Placebo|Matching Placebo
10194|NCT02338336|E2|Reported Event|Nowarta110|All combined Nowarta110 doses
10195|NCT02338336|E1|Reported Event|Placebo|Matching Placebo
10134|NCT02340338|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10135|NCT02340338|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10136|NCT02340338|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10137|NCT02340338|P7|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10138|NCT02340338|P6|Participant Flow|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10139|NCT02340338|P5|Participant Flow|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10140|NCT02340338|P4|Participant Flow|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10141|NCT02340338|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10196|NCT02337959|B4|Baseline|Total|Total of all reporting groups
10197|NCT02337959|B3|Baseline|Predicate & Investigational-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
10198|NCT02337959|B2|Baseline|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
10355|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10142|NCT02340338|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10143|NCT02340338|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10144|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10145|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10146|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10147|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10148|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10149|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10199|NCT02337959|B1|Baseline|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
10200|NCT02337959|P3|Participant Flow|Predicate & Investigational - Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
10201|NCT02337959|P2|Participant Flow|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
10356|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10150|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10151|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10152|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10153|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10154|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10155|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10156|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10157|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10158|NCT02340338|E7|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10159|NCT02340338|E6|Reported Event|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10160|NCT02340338|E5|Reported Event|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10161|NCT02340338|E4|Reported Event|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10162|NCT02340338|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10163|NCT02340338|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10164|NCT02340338|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
10165|NCT02339246|B3|Baseline|Total|Total of all reporting groups
10166|NCT02339246|B2|Baseline|Prograf vs Astagraf XL vs Envarsus XR|"Prograf capsules twice daily Astagraf XL capsules once daily Envarsus XR tablets once daily~Prograf vs Astagraf XL vs Envarsus XR: Prograf vs Astagraf XL vs Envarsus XR"
10167|NCT02339246|B1|Baseline|Prograf vs Envarsus XR vs Astagraf XL|"Prograft capsules Twice daily Envarsus XR tablets once daily Astagraf XL capsules once daily~Prograf vs Envarsus XR vs Astagraf XL: prograf vs Envarsus XR vs Astagraf XL"
10168|NCT02339246|P3|Participant Flow|Prograf|Prograf capsules twice daily.
10169|NCT02339246|P2|Participant Flow|Astagraf XL|Astagraf XL capsules once daily.
10170|NCT02339246|P1|Participant Flow|Envarsus XR|Envarsus XR tablets once daily.
10171|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
10172|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
10173|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
10174|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
10175|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
10176|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
10177|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
10178|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
10179|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
10180|NCT02339246|E3|Reported Event|Prograf|Prograf capsules twice daily.
10181|NCT02339246|E2|Reported Event|Astagraf XR|Astagraf XR capsules once daily.
10182|NCT02339246|E1|Reported Event|Envarsus XR|Envarsus XR tablets once daily.
10183|NCT02338336|B3|Baseline|Total|Total of all reporting groups
10184|NCT02338336|B2|Baseline|Nowarta110|All combined Nowarta110 doses
10185|NCT02338336|B1|Baseline|Placebo|Matching Placebo
10186|NCT02338336|P4|Participant Flow|Nowarta110 10 Drops|Nowarta110 10 drops administered topically
10202|NCT02337959|P1|Participant Flow|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
10203|NCT02337959|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-Plus 3543/C (GOS & CsI) and vice versa.
10204|NCT02337959|O2|Outcome|Investigational|DRX Plus 3543/C (GOS & CsI) Detectors, Cadavers & Live Subjects
10205|NCT02337959|O1|Outcome|Predicate|DRX-1 Detector, Cadavers & Live Subjects
10206|NCT02337959|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
10207|NCT02337959|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
10208|NCT02337959|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
10209|NCT02336958|B3|Baseline|Total|Total of all reporting groups
10210|NCT02336958|B2|Baseline|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10211|NCT02336958|B1|Baseline|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
10212|NCT02336958|P2|Participant Flow|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10213|NCT02336958|P1|Participant Flow|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
10214|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10215|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
10216|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10217|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
10218|NCT02336958|E2|Reported Event|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
10219|NCT02336958|E1|Reported Event|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
10220|NCT02336763|B1|Baseline|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10221|NCT02336763|P1|Participant Flow|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10304|NCT02335710|P1|Participant Flow|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10222|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10223|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10224|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10225|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10226|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10227|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10228|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10229|NCT02336763|E1|Reported Event|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
10230|NCT02336607|B5|Baseline|Total|Total of all reporting groups
10231|NCT02336607|B4|Baseline|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10232|NCT02336607|B3|Baseline|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10233|NCT02336607|B2|Baseline|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10234|NCT02336607|B1|Baseline|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10235|NCT02336607|P4|Participant Flow|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10236|NCT02336607|P3|Participant Flow|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10237|NCT02336607|P2|Participant Flow|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10238|NCT02336607|P1|Participant Flow|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10239|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10240|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10241|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10242|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10243|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10244|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10245|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10246|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10247|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10248|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10249|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10250|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10251|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10252|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10253|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10254|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10255|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10256|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10257|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10258|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10259|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10260|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10261|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10262|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10263|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10264|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10265|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10266|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10267|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10268|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10269|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10270|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10271|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10272|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10273|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10274|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10275|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10276|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10305|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10414|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10277|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10278|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10279|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10280|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10281|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10282|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10283|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10284|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10285|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10286|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10287|NCT02336607|E4|Reported Event|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
10288|NCT02336607|E3|Reported Event|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
10289|NCT02336607|E2|Reported Event|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
10290|NCT02336607|E1|Reported Event|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
10291|NCT02336438|B1|Baseline|Baseline Phase (Control), Crossover to Treatment (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10299|NCT02336438|E1|Reported Event|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10292|NCT02336438|P1|Participant Flow|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10293|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10294|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10295|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10296|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10297|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10298|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
10300|NCT02335710|B3|Baseline|Total|Total of all reporting groups
10301|NCT02335710|B2|Baseline|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10302|NCT02335710|B1|Baseline|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates~Journey II BCS TKA"
11877|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
10306|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10307|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10308|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10309|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10310|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10311|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10312|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10313|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10314|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10315|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10316|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10317|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10318|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10319|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10320|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10321|NCT02335710|E2|Reported Event|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
10322|NCT02335710|E1|Reported Event|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
10323|NCT02334982|B8|Baseline|Total|Total of all reporting groups
10324|NCT02334982|B7|Baseline|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
10325|NCT02334982|B6|Baseline|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
10326|NCT02334982|B5|Baseline|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
10327|NCT02334982|B4|Baseline|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
10328|NCT02334982|B3|Baseline|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10329|NCT02334982|B2|Baseline|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
10330|NCT02334982|B1|Baseline|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
10331|NCT02334982|P7|Participant Flow|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
10332|NCT02334982|P6|Participant Flow|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
10333|NCT02334982|P5|Participant Flow|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
10334|NCT02334982|P4|Participant Flow|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
10335|NCT02334982|P3|Participant Flow|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10336|NCT02334982|P2|Participant Flow|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
10337|NCT02334982|P1|Participant Flow|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
10338|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10339|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10340|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10341|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10342|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10343|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10344|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10345|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10346|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10347|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10348|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10349|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10350|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10351|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10352|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10353|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10354|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10415|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10357|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10358|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10359|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10360|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10361|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10362|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10363|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10364|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10365|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10366|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10367|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10368|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10369|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10370|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10371|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10372|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10373|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10374|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10375|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10376|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10377|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10378|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10379|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10380|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10381|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10382|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10383|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10384|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10385|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10386|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10387|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10388|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10389|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10390|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10391|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10392|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10393|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10394|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10395|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10396|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10397|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10398|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10399|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10400|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10401|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10402|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10403|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10404|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
10405|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10406|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10407|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10408|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
10409|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10410|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
10411|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10412|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10413|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10416|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
10417|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10418|NCT02334982|O6|Outcome|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
10419|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10420|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10421|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10422|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10423|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10424|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
10425|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10426|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
10427|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10428|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10429|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10430|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10431|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10432|NCT02334982|E8|Reported Event|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
10433|NCT02334982|E7|Reported Event|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
10434|NCT02334982|E6|Reported Event|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
10435|NCT02334982|E5|Reported Event|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
10436|NCT02334982|E4|Reported Event|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
10437|NCT02334982|E3|Reported Event|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
10438|NCT02334982|E2|Reported Event|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
10439|NCT02334982|E1|Reported Event|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
10440|NCT02334787|B5|Baseline|Total|Total of all reporting groups
10441|NCT02334787|B4|Baseline|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
10442|NCT02334787|B3|Baseline|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
10443|NCT02334787|B2|Baseline|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
10444|NCT02334787|B1|Baseline|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
10445|NCT02334787|P4|Participant Flow|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
10446|NCT02334787|P3|Participant Flow|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
10447|NCT02334787|P2|Participant Flow|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
10448|NCT02334787|P1|Participant Flow|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
10449|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10450|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10451|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10452|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
10453|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
10454|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
10455|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10456|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10457|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10492|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10458|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
10459|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
10460|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
10461|NCT02334787|E8|Reported Event|Placebo Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
10462|NCT02334787|E7|Reported Event|3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10463|NCT02334787|E6|Reported Event|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10464|NCT02334787|E5|Reported Event|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
10465|NCT02334787|E4|Reported Event|Placebo in a Single Adminstaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment.
10466|NCT02334787|E3|Reported Event|3% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
10467|NCT02334787|E2|Reported Event|1% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
10468|NCT02334787|E1|Reported Event|0.3 % OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment
10469|NCT02332798|B4|Baseline|Total|Total of all reporting groups
10470|NCT02332798|B3|Baseline|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10471|NCT02332798|B2|Baseline|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10472|NCT02332798|B1|Baseline|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10473|NCT02332798|P3|Participant Flow|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10474|NCT02332798|P2|Participant Flow|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10475|NCT02332798|P1|Participant Flow|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.
10476|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10477|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10478|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10479|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10480|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10481|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10482|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10483|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10484|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10485|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10486|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10487|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10488|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10489|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10490|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10491|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
11878|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
10493|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10494|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10495|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10496|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10497|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10498|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10499|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10500|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10501|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10502|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10503|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10504|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10505|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10506|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10507|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10508|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10509|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10510|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10511|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10512|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10513|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10514|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10515|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10516|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10517|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10518|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10519|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10520|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10521|NCT02332798|E3|Reported Event|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10522|NCT02332798|E2|Reported Event|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10523|NCT02332798|E1|Reported Event|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
10524|NCT02331589|B3|Baseline|Total|Total of all reporting groups
10525|NCT02331589|B2|Baseline|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10526|NCT02331589|B1|Baseline|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10527|NCT02331589|P2|Participant Flow|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10528|NCT02331589|P1|Participant Flow|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10529|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10530|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10924|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10531|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10532|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10533|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10534|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10535|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10536|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10537|NCT02331589|E2|Reported Event|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
10538|NCT02331589|E1|Reported Event|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
10539|NCT02331446|B5|Baseline|Total|Total of all reporting groups
10540|NCT02331446|B4|Baseline|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10541|NCT02331446|B3|Baseline|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10542|NCT02331446|B2|Baseline|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10543|NCT02331446|B1|Baseline|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10544|NCT02331446|P4|Participant Flow|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10545|NCT02331446|P3|Participant Flow|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10546|NCT02331446|P2|Participant Flow|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10547|NCT02331446|P1|Participant Flow|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10548|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10549|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10550|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10551|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10552|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10553|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10554|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10555|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10556|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10557|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10558|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10559|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10560|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10561|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10562|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10563|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10925|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10564|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10565|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10566|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10567|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10568|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10569|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10570|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10571|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10572|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10573|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10574|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10575|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10576|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10577|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10578|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10579|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10580|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10581|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10582|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10583|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10584|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10585|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10586|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10587|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10588|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10589|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10590|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10591|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10592|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10593|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10594|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10595|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10596|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10597|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10598|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10599|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10600|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10601|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10602|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10603|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10604|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10605|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10606|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10607|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10608|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10609|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10610|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10611|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10612|NCT02331446|E4|Reported Event|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
10613|NCT02331446|E3|Reported Event|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
10614|NCT02331446|E2|Reported Event|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
10615|NCT02331446|E1|Reported Event|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
10616|NCT02330523|B3|Baseline|Total|Total of all reporting groups
10617|NCT02330523|B2|Baseline|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10618|NCT02330523|B1|Baseline|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10619|NCT02330523|P2|Participant Flow|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10791|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10792|NCT02329223|E3|Reported Event|Placebo|Placebo
10620|NCT02330523|P1|Participant Flow|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10621|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10622|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10623|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10624|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10625|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10626|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10627|NCT02330523|E2|Reported Event|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10628|NCT02330523|E1|Reported Event|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
10629|NCT02329964|B3|Baseline|Total|Total of all reporting groups
10630|NCT02329964|B2|Baseline|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10793|NCT02329223|E2|Reported Event|IGE025 150 mg|IGE025 150 mg
10794|NCT02329223|E1|Reported Event|IGE025 300 mg|IGE025 300 mg
10795|NCT02329015|B3|Baseline|Total|Total of all reporting groups
10631|NCT02329964|B1|Baseline|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10632|NCT02329964|P2|Participant Flow|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10633|NCT02329964|P1|Participant Flow|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10634|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10635|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10636|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10637|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10638|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10639|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10640|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10641|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10642|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10643|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10644|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10645|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
11879|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
10646|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10647|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10648|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10649|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10650|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10651|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10652|NCT02329964|E2|Reported Event|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
10653|NCT02329964|E1|Reported Event|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
10654|NCT02329730|B5|Baseline|Total|Total of all reporting groups
10655|NCT02329730|B4|Baseline|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10656|NCT02329730|B3|Baseline|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10657|NCT02329730|B2|Baseline|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10658|NCT02329730|B1|Baseline|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10659|NCT02329730|P12|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
10734|NCT02329730|E9|Reported Event|Tuberculosis Subjects- 1μg/ml EC and Placebo|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10660|NCT02329730|P11|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
10661|NCT02329730|P10|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
10662|NCT02329730|P9|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
10663|NCT02329730|P8|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
10664|NCT02329730|P7|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
10665|NCT02329730|P6|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
10666|NCT02329730|P5|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
10667|NCT02329730|P4|Participant Flow|Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
10668|NCT02329730|P3|Participant Flow|Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
10669|NCT02329730|P2|Participant Flow|Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
10670|NCT02329730|P1|Participant Flow|Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
10671|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10672|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10776|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10777|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10778|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10673|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10674|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10675|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10676|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10677|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10678|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10679|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10680|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10681|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10682|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10683|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10684|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10779|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10780|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10781|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10685|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10686|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10687|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10688|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10689|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10690|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10691|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10692|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10693|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10694|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10695|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10696|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10782|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10783|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10784|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10697|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10698|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10699|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10700|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10701|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10702|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10703|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10704|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10705|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10706|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10707|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10708|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10785|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10786|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10787|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10709|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10710|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10711|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10712|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10713|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10714|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10715|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10716|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10717|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10718|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10719|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10720|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10788|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10789|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10790|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10721|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10722|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10723|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10724|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10725|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10726|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10727|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10728|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10729|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10730|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
10731|NCT02329730|E12|Reported Event|Tuberculosis Subjects- 20μg/ml EC and Placebo|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10732|NCT02329730|E11|Reported Event|Tuberculosis Subjects- 10μg/ml EC and Placebo|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10733|NCT02329730|E10|Reported Event|Tuberculosis Subjects- 5μg/ml EC and Placebo|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10796|NCT02329015|B2|Baseline|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10735|NCT02329730|E8|Reported Event|Tuberculosis Subjects- 20μg/ml EC and TB-PPD|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10736|NCT02329730|E7|Reported Event|Tuberculosis Subjects- 10μg/ml EC and TB-PPD|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10737|NCT02329730|E6|Reported Event|Tuberculosis Subjects- 5μg/ml EC and TB-PPD|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10738|NCT02329730|E5|Reported Event|Tuberculosis Subjects- 1μg/mlEC and TB-PPD|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10739|NCT02329730|E4|Reported Event|Healthy Subjects-20μg/ml EC and TB-PPD|The healthy subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10740|NCT02329730|E3|Reported Event|Healthy Subjects-10μg/ml EC and TB-PPD|The healthy subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10741|NCT02329730|E2|Reported Event|Healthy Subjects-5μg/ml EC and TB-PPD|The healthy subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10742|NCT02329730|E1|Reported Event|Healthy Subjects-1μg/ml ECand TB-PPD|The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
10743|NCT02329600|B4|Baseline|Total|Total of all reporting groups
10744|NCT02329600|B3|Baseline|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10745|NCT02329600|B2|Baseline|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10746|NCT02329600|B1|Baseline|Control Subjects|10 systemically healthy control subjects taking no medication.
10747|NCT02329600|P3|Participant Flow|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10748|NCT02329600|P2|Participant Flow|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10749|NCT02329600|P1|Participant Flow|Control Subjects|10 systemically healthy control subjects taking no medication.
10874|NCT02327117|E2|Reported Event|Normal Saline|Normal saline
10750|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10751|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10752|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
10753|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10754|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10755|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
10756|NCT02329600|E3|Reported Event|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10757|NCT02329600|E2|Reported Event|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
10758|NCT02329600|E1|Reported Event|Control Subjects|10 systemically healthy control subjects taking no medication.
10759|NCT02329223|B4|Baseline|Total|Total of all reporting groups
10760|NCT02329223|B3|Baseline|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10761|NCT02329223|B2|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10762|NCT02329223|B1|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10763|NCT02329223|P3|Participant Flow|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10764|NCT02329223|P2|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10765|NCT02329223|P1|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10766|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10767|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10768|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10769|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10770|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10771|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10772|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10773|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
10774|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
10775|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
10875|NCT02327117|E1|Reported Event|Tranexamic Acid|Tranexamic Acid
10797|NCT02329015|B1|Baseline|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10798|NCT02329015|P2|Participant Flow|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10799|NCT02329015|P1|Participant Flow|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10800|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10801|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10802|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10803|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10804|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10805|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10806|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10807|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10808|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10809|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10810|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10811|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10812|NCT02329015|E2|Reported Event|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
10813|NCT02329015|E1|Reported Event|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
10814|NCT02328937|B1|Baseline|Overall|All subjects that were dispensed at least one study lens.
10815|NCT02328937|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Etafilcon A|Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
10816|NCT02328937|P5|Participant Flow|Comfilcon A/Etafilcon A/Lotrafilcon B|Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.
10817|NCT02328937|P4|Participant Flow|Lotrafilcon B/Comfilcon A/Etafilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.
10818|NCT02328937|P3|Participant Flow|Lotrafilcon B/Etafilcon A/Comfilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.
10819|NCT02328937|P2|Participant Flow|Etafilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.
10820|NCT02328937|P1|Participant Flow|Etafilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.
10821|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
10822|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
10823|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
10824|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
10825|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
10826|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
10827|NCT02328937|E3|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
10828|NCT02328937|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
10829|NCT02328937|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
10830|NCT02328404|B3|Baseline|Total|Total of all reporting groups
10831|NCT02328404|B2|Baseline|Placebo (Biodal 50,000IU Placebo)|"Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route~Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months"
10832|NCT02328404|B1|Baseline|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10833|NCT02328404|P2|Participant Flow|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10834|NCT02328404|P1|Participant Flow|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10835|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10836|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10837|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10838|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10839|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10840|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10841|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10842|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10843|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10844|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10845|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months"
10846|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10847|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10848|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10849|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10850|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10851|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10852|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10853|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10854|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10855|NCT02328404|O2|Outcome|Placebo|"Placebo coated tablet by oral route~Placebo: placebo coated tablet by oral route"
10856|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10857|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10858|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10859|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10860|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10861|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10862|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10863|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10864|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10865|NCT02328404|E2|Reported Event|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
10866|NCT02328404|E1|Reported Event|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
10867|NCT02327117|B3|Baseline|Total|Total of all reporting groups
10868|NCT02327117|B2|Baseline|Normal Saline|Normal saline
10869|NCT02327117|B1|Baseline|Tranexamic Acid|Tranexamic Acid
10870|NCT02327117|P2|Participant Flow|Normal Saline|Normal saline
10871|NCT02327117|P1|Participant Flow|Tranexamic Acid|Tranexamic Acid
10872|NCT02327117|O2|Outcome|Normal Saline|Normal saline
10873|NCT02327117|O1|Outcome|Tranexamic Acid|Tranexamic Acid
10878|NCT02325856|B1|Baseline|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
10879|NCT02325856|P2|Participant Flow|Control Group|Dry weight determined by clinical symptoms
10880|NCT02325856|P1|Participant Flow|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
10881|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
10882|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
10883|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
10884|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
10885|NCT02325856|E2|Reported Event|Control Group|Dry weight determined by clinical symptoms
10886|NCT02325856|E1|Reported Event|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
10887|NCT02325518|B3|Baseline|Total|Total of all reporting groups
10888|NCT02325518|B2|Baseline|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10889|NCT02325518|B1|Baseline|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10890|NCT02325518|P2|Participant Flow|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10891|NCT02325518|P1|Participant Flow|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual prostaglandin-analog (PGA) monotherapy, 1 drop in each eye once daily for 8 weeks.
10892|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10893|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10894|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10895|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10896|NCT02325518|E3|Reported Event|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10897|NCT02325518|E2|Reported Event|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
10898|NCT02325518|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
10899|NCT02322788|B1|Baseline|Overall|Total number of participants in the Full analysis set
10900|NCT02322788|P4|Participant Flow|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
10901|NCT02322788|P3|Participant Flow|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
10902|NCT02322788|P2|Participant Flow|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
10903|NCT02322788|P1|Participant Flow|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
10904|NCT02322788|O4|Outcome|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
10905|NCT02322788|O3|Outcome|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
10906|NCT02322788|O2|Outcome|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
10907|NCT02322788|O1|Outcome|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
10908|NCT02322788|E4|Reported Event|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
10909|NCT02322788|E3|Reported Event|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
10910|NCT02322788|E2|Reported Event|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
10911|NCT02322788|E1|Reported Event|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
10912|NCT02322775|B3|Baseline|Total|Total of all reporting groups
10913|NCT02322775|B2|Baseline|Placebo|Placebo administered subcutaneously every 4 weeks
10914|NCT02322775|B1|Baseline|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10915|NCT02322775|P2|Participant Flow|Placebo|Placebo administered subcutaneously every 4 weeks
10916|NCT02322775|P1|Participant Flow|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10917|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10918|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10919|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10920|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10921|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10922|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10923|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
12566|NCT02289105|B3|Baseline|Total|Total of all reporting groups
10926|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10927|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10928|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10929|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10930|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10931|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10932|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10933|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10934|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10935|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10936|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10937|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
10938|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10939|NCT02322775|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks
10940|NCT02322775|E1|Reported Event|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
10941|NCT02322749|B1|Baseline|Overall Study|All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
10942|NCT02322749|P6|Participant Flow|Sequence CBA|Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10943|NCT02322749|P5|Participant Flow|Sequence CAB|Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10944|NCT02322749|P4|Participant Flow|Sequence BCA|Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10945|NCT02322749|P3|Participant Flow|Sequence BAC|Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10946|NCT02322749|P2|Participant Flow|Sequence ACB|Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10947|NCT02322749|P1|Participant Flow|Sequence ABC|Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
10948|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10949|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10950|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10951|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10952|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10953|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10954|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10955|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10956|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10957|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10958|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10959|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10960|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10961|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10962|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10963|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10964|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10965|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10966|NCT02322749|E3|Reported Event|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10967|NCT02322749|E2|Reported Event|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10968|NCT02322749|E1|Reported Event|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
10969|NCT02322528|B1|Baseline|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
10970|NCT02322528|P1|Participant Flow|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
10971|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
10972|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
10973|NCT02322528|E1|Reported Event|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
10974|NCT02322216|B3|Baseline|Total|Total of all reporting groups
10975|NCT02322216|B2|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
10976|NCT02322216|B1|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
10977|NCT02322216|P2|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
10978|NCT02322216|P1|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
10979|NCT02322216|O2|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
10980|NCT02322216|O1|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
10981|NCT02322216|E3|Reported Event|PATANOL|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%
10982|NCT02322216|E2|Reported Event|PATADAY|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%
10983|NCT02322216|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
10984|NCT02320695|B1|Baseline|OVERALL|This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
10985|NCT02320695|P1|Participant Flow|OVERALL|Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
10986|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
10987|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
10988|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
10989|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
10990|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
10991|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
10992|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
10993|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
10994|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
10995|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
10996|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
10997|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
10998|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
10999|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
11000|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
11001|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
11002|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
11003|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
11004|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
11005|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
11006|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
11007|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
11008|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
11009|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
11010|NCT02320695|E1|Reported Event|OVERALL|This includes all 60 randomized subjects.
11011|NCT02320396|B3|Baseline|Total|Total of all reporting groups
11012|NCT02320396|B2|Baseline|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11013|NCT02320396|B1|Baseline|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11014|NCT02320396|P2|Participant Flow|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11015|NCT02320396|P1|Participant Flow|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11016|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11017|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11018|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11019|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11020|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11021|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11022|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11023|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11024|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11056|NCT02319525|B1|Baseline|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11025|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11026|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11027|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11028|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11029|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11030|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11031|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11032|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11033|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11034|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11035|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11036|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11037|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11038|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11039|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11040|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11041|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11042|NCT02320396|E2|Reported Event|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11043|NCT02320396|E1|Reported Event|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
11044|NCT02320227|B1|Baseline|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11045|NCT02320227|P1|Participant Flow|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11046|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
11047|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
11048|NCT02320227|E1|Reported Event|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
11049|NCT02320214|B1|Baseline|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11050|NCT02320214|P1|Participant Flow|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11051|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11052|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11053|NCT02320214|E1|Reported Event|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
11054|NCT02319525|B3|Baseline|Total|Total of all reporting groups
11055|NCT02319525|B2|Baseline|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
12610|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
11057|NCT02319525|P2|Participant Flow|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11058|NCT02319525|P1|Participant Flow|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11059|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11060|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11061|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11062|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11063|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11064|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11065|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11066|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11067|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11068|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11069|NCT02319525|E2|Reported Event|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
11070|NCT02319525|E1|Reported Event|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
11071|NCT02319486|B1|Baseline|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11072|NCT02319486|P1|Participant Flow|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11073|NCT02319486|O2|Outcome|CEV With/Without Carboplatin - Stage 3|CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
11074|NCT02319486|O1|Outcome|CEV With/Without Carboplatin- Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11075|NCT02319486|E2|Reported Event|CEV With/Without Carboplatin-Stage 3|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11076|NCT02319486|E1|Reported Event|CEV With/Without Carboplatin-Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
11077|NCT02319148|B4|Baseline|Total|Total of all reporting groups
11078|NCT02319148|B3|Baseline|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11079|NCT02319148|B2|Baseline|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11080|NCT02319148|B1|Baseline|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11081|NCT02319148|P4|Participant Flow|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11082|NCT02319148|P3|Participant Flow|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11083|NCT02319148|P2|Participant Flow|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11084|NCT02319148|P1|Participant Flow|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11085|NCT02319148|O7|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11086|NCT02319148|O6|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11087|NCT02319148|O5|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11088|NCT02319148|O4|Outcome|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
11089|NCT02319148|O3|Outcome|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
11090|NCT02319148|O2|Outcome|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
11091|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11092|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11093|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11094|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11095|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11096|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11097|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11098|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11099|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11100|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11101|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11102|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11103|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11104|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11105|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11106|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11107|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11108|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11109|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11110|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11111|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11112|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11113|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11114|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11115|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11116|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11117|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11118|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11119|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11120|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11121|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11122|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11123|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11124|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11462|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11125|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11126|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11127|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11128|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11129|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11130|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11131|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11132|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11133|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11134|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11135|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11136|NCT02319148|E7|Reported Event|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
11137|NCT02319148|E6|Reported Event|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
11138|NCT02319148|E5|Reported Event|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
11139|NCT02319148|E4|Reported Event|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
11140|NCT02319148|E3|Reported Event|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
11141|NCT02319148|E2|Reported Event|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
11142|NCT02319148|E1|Reported Event|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
11143|NCT02319031|B3|Baseline|Total|Total of all reporting groups
11144|NCT02319031|B2|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11145|NCT02319031|B1|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11146|NCT02319031|P2|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11147|NCT02319031|P1|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11148|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
17834|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
11149|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11150|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11151|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11152|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11153|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11154|NCT02319031|E2|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11155|NCT02319031|E1|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
11156|NCT02318940|B3|Baseline|Total|Total of all reporting groups
11157|NCT02318940|B2|Baseline|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11158|NCT02318940|B1|Baseline|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11159|NCT02318940|P2|Participant Flow|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11160|NCT02318940|P1|Participant Flow|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11161|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11162|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11163|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11463|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11164|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11165|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11166|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11167|NCT02318940|E2|Reported Event|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
11168|NCT02318940|E1|Reported Event|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
11169|NCT02318693|B3|Baseline|Total|Total of all reporting groups
11170|NCT02318693|B2|Baseline|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11171|NCT02318693|B1|Baseline|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11172|NCT02318693|P2|Participant Flow|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
11173|NCT02318693|P1|Participant Flow|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11174|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11175|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11176|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11177|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11178|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11179|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11180|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11181|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11182|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11183|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11184|NCT02318693|E2|Reported Event|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
11185|NCT02318693|E1|Reported Event|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
11186|NCT02317809|B1|Baseline|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
11187|NCT02317809|P2|Participant Flow|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11188|NCT02317809|P1|Participant Flow|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11189|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11190|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11191|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11192|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11193|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11194|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11353|NCT02314689|B1|Baseline|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11195|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11196|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11197|NCT02317809|O2|Outcome|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11198|NCT02317809|O1|Outcome|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
11199|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11200|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11201|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11202|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11203|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11204|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11205|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11206|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11207|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11208|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11209|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11210|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11211|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11212|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11213|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11214|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11215|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11216|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11217|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11218|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11219|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11220|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11221|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11222|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11223|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11224|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11225|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11226|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11227|NCT02317809|E2|Reported Event|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
11228|NCT02317809|E1|Reported Event|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
11229|NCT02317510|B3|Baseline|Total|Total of all reporting groups
11230|NCT02317510|B2|Baseline|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
11231|NCT02317510|B1|Baseline|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
11232|NCT02317510|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11233|NCT02317510|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11234|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11235|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11236|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11237|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11238|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11239|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11240|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11241|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11242|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11243|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11244|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11245|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11246|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11247|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11248|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11249|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11250|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11251|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11252|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11253|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11254|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
11255|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11256|NCT02317510|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
11257|NCT02317510|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
11258|NCT02317510|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
11259|NCT02317510|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in General Anesthesia
11260|NCT02317016|B1|Baseline|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
11261|NCT02317016|P1|Participant Flow|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
11262|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11263|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11264|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11265|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11266|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11267|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11268|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11269|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11270|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11271|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11272|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11273|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11274|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11320|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.
11275|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11276|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11277|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11278|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11279|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11280|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11281|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
11282|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
11283|NCT02317016|E1|Reported Event|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
11284|NCT02316769|B3|Baseline|Total|Total of all reporting groups
11285|NCT02316769|B2|Baseline|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11286|NCT02316769|B1|Baseline|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11287|NCT02316769|P2|Participant Flow|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11288|NCT02316769|P1|Participant Flow|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11289|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11290|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11291|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11292|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11293|NCT02316769|E2|Reported Event|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
11294|NCT02316769|E1|Reported Event|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
11295|NCT02316613|B1|Baseline|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11296|NCT02316613|P1|Participant Flow|All Participants|Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11297|NCT02316613|O2|Outcome|Maintenance Therapy|During maintenance therapy the participants received or did not received treatment with the MabThera.
11298|NCT02316613|O1|Outcome|First Induction|During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.
11351|NCT02315989|O1|Outcome|Safety|"proton therapy~proton therapy: proton therapy"
11352|NCT02315989|E1|Reported Event|Safety|"proton therapy~proton therapy: proton therapy"
11880|NCT02305329|E4|Reported Event|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
11299|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11300|NCT02316613|O1|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11301|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11302|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
11303|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11304|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
11305|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11306|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
11307|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
11308|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
11309|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
11310|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
11311|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
11312|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
11313|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11314|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11315|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11316|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11317|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11318|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11319|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11464|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11321|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received MabThera treatment over the first study induction period was reported.
11322|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11323|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11324|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11325|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
11326|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
11327|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
11328|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
11329|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment.
11330|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11331|NCT02316613|E1|Reported Event|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
11332|NCT02316366|B3|Baseline|Total|Total of all reporting groups
11333|NCT02316366|B2|Baseline|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11334|NCT02316366|B1|Baseline|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11335|NCT02316366|P2|Participant Flow|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11336|NCT02316366|P1|Participant Flow|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11337|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11338|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11339|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11340|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11341|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11342|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11343|NCT02316366|E2|Reported Event|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
11344|NCT02316366|E1|Reported Event|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
11345|NCT02315989|B1|Baseline|Safety|"proton therapy~proton therapy: proton therapy"
11346|NCT02315989|P1|Participant Flow|Safety|"proton therapy~proton therapy: proton therapy"
11347|NCT02315989|O3|Outcome|Inevaluable|Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
11348|NCT02315989|O2|Outcome|Partial Response|Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
11349|NCT02315989|O1|Outcome|Stable Disease|Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
11350|NCT02315989|O1|Outcome|The Frequency of Operation of the System Error|6 subjects received a total of 165 proton therapy, a total of 21 times the system running abnormalities. There was no correlation between system abnormalities during the study and the adverse events.
11354|NCT02314689|P1|Participant Flow|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11355|NCT02314689|O1|Outcome|IV Citrulline|"IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.~Intravenous (IV) citrulline"
11356|NCT02314689|E1|Reported Event|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
11357|NCT02314637|B3|Baseline|Total|Total of all reporting groups
11358|NCT02314637|B2|Baseline|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11359|NCT02314637|B1|Baseline|Teneligliptin|Teneligliptin for 52 weeks
11360|NCT02314637|P2|Participant Flow|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
11361|NCT02314637|P1|Participant Flow|Teneligliptin|Teneligliptin for 52 weeks
11362|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11363|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
11364|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11365|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
11366|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11367|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
11368|NCT02314637|E2|Reported Event|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
11369|NCT02314637|E1|Reported Event|Teneligliptin|Teneligliptin for 52 weeks
11370|NCT02314546|B4|Baseline|Total|Total of all reporting groups
11371|NCT02314546|B3|Baseline|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11372|NCT02314546|B2|Baseline|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11373|NCT02314546|B1|Baseline|Saline Placebo|Control patients received intranasal saline.
11374|NCT02314546|P3|Participant Flow|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11375|NCT02314546|P2|Participant Flow|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11376|NCT02314546|P1|Participant Flow|Saline Placebo|Control patients received intranasal saline.
11377|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11378|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11379|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11380|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11381|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11382|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11383|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11384|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11385|NCT02314546|O1|Outcome|Saline Placebo|Control patients will received intranasal saline.
11386|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11387|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11388|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11389|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11390|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11391|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11392|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11393|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11394|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11395|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11396|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11397|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
11398|NCT02314546|E3|Reported Event|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
11399|NCT02314546|E2|Reported Event|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
11400|NCT02314546|E1|Reported Event|Saline Placebo|Control patients received intranasal saline.
11401|NCT02314260|B1|Baseline|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11419|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11402|NCT02314260|P1|Participant Flow|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11403|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11404|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11405|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11406|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11407|NCT02314260|E1|Reported Event|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
11408|NCT02314104|B4|Baseline|Total|Total of all reporting groups
11409|NCT02314104|B3|Baseline|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11410|NCT02314104|B2|Baseline|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11411|NCT02314104|B1|Baseline|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11412|NCT02314104|P3|Participant Flow|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11413|NCT02314104|P2|Participant Flow|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11414|NCT02314104|P1|Participant Flow|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11415|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11416|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11417|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11418|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11439|NCT02313766|P1|Participant Flow|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11420|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11421|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11422|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11423|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11424|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11425|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11426|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11427|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11428|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11429|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11430|NCT02314104|E3|Reported Event|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11431|NCT02314104|E2|Reported Event|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11432|NCT02314104|E1|Reported Event|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
11433|NCT02313766|B4|Baseline|Total|Total of all reporting groups
11434|NCT02313766|B3|Baseline|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11435|NCT02313766|B2|Baseline|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11436|NCT02313766|B1|Baseline|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11437|NCT02313766|P3|Participant Flow|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11438|NCT02313766|P2|Participant Flow|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11461|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11440|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11441|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11442|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11443|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11444|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11445|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11446|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11447|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11448|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11449|NCT02313766|E3|Reported Event|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
11450|NCT02313766|E2|Reported Event|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
11451|NCT02313766|E1|Reported Event|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
11452|NCT02313558|B3|Baseline|Total|Total of all reporting groups
11453|NCT02313558|B2|Baseline|Control Dentifrice|"use the control dentifrice to brush teeth twice daily for 12 weeks~Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks"
11454|NCT02313558|B1|Baseline|Dentifrice Containing Ilex Rotunda Thunb|"use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks~Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks"
11455|NCT02313558|P2|Participant Flow|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11456|NCT02313558|P1|Participant Flow|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11457|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11458|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11459|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11460|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11465|NCT02313558|E2|Reported Event|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
11466|NCT02313558|E1|Reported Event|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
11467|NCT02313233|B3|Baseline|Total|Total of all reporting groups
11468|NCT02313233|B2|Baseline|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11469|NCT02313233|B1|Baseline|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11470|NCT02313233|P2|Participant Flow|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11471|NCT02313233|P1|Participant Flow|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11472|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11473|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water."
11474|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11475|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11476|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11477|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11478|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11479|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11480|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11481|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11482|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11483|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11484|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11485|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11486|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11487|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11488|NCT02313233|E2|Reported Event|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
11489|NCT02313233|E1|Reported Event|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
11490|NCT02313155|B3|Baseline|Total|Total of all reporting groups
11491|NCT02313155|B2|Baseline|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11492|NCT02313155|B1|Baseline|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11493|NCT02313155|P2|Participant Flow|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11494|NCT02313155|P1|Participant Flow|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11495|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11496|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11497|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11498|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11499|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11500|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11501|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11502|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11503|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11504|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11505|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11506|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11507|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11508|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11509|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11510|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11511|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11512|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11513|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11514|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11515|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11516|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11517|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11518|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11519|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11520|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11521|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11522|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11523|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11524|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11525|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11526|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11527|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11528|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11529|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11530|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11531|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11532|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11533|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11534|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11535|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11536|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11537|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11538|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11539|NCT02313155|E2|Reported Event|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
11540|NCT02313155|E1|Reported Event|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
11541|NCT02312739|B3|Baseline|Total|Total of all reporting groups
11542|NCT02312739|B2|Baseline|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11543|NCT02312739|B1|Baseline|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11544|NCT02312739|P2|Participant Flow|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11545|NCT02312739|P1|Participant Flow|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11546|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11547|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11548|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11549|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11614|NCT02310646|O6|Outcome|Prefer Gel - Fairly Important Factor|Subjects who prefer gel
11615|NCT02310646|O5|Outcome|Prefer Gel - Very Important Factor|Subjects who prefer gel
11616|NCT02310646|O4|Outcome|Prefer Foam - Not at All Important Factor|Subjects who prefer foam
11550|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11551|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11552|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11553|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11554|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11555|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11556|NCT02312739|E2|Reported Event|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
11557|NCT02312739|E1|Reported Event|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
11558|NCT02312726|B1|Baseline|Total Participants Enrolled in Study|Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
11559|NCT02312726|P3|Participant Flow|Excluded|Participants who did not meet inclusion criteria or declined after consent.
11560|NCT02312726|P2|Participant Flow|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11561|NCT02312726|P1|Participant Flow|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11617|NCT02310646|O3|Outcome|Prefer Foam - Not Very Important Factor|Subjects who prefer foam
17835|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
11562|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11563|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11564|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11565|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11566|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11567|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11568|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11569|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11570|NCT02312726|E2|Reported Event|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11571|NCT02312726|E1|Reported Event|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
11572|NCT02312154|B1|Baseline|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11573|NCT02312154|P1|Participant Flow|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11574|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11575|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11576|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11577|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11578|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11579|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11580|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11581|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11582|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11583|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11584|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
11585|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11586|NCT02312154|E1|Reported Event|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
11587|NCT02311309|B4|Baseline|Total|Total of all reporting groups
11588|NCT02311309|B3|Baseline|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
11618|NCT02310646|O2|Outcome|Prefer Foam - Fairly Important Factor|Subjects who prefer foam
11619|NCT02310646|O1|Outcome|Prefer Foam - Very Important Factor|Subjects who prefer foam
11589|NCT02311309|B2|Baseline|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11590|NCT02311309|B1|Baseline|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11591|NCT02311309|P3|Participant Flow|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
11592|NCT02311309|P2|Participant Flow|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11593|NCT02311309|P1|Participant Flow|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11594|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
11595|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11596|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11597|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
11598|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11599|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11600|NCT02311309|E3|Reported Event|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
11601|NCT02311309|E2|Reported Event|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
11602|NCT02311309|E1|Reported Event|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
11603|NCT02310776|B1|Baseline|Automated & Handheld Beast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11604|NCT02310776|P1|Participant Flow|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11605|NCT02310776|O1|Outcome|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11606|NCT02310776|E1|Reported Event|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
11607|NCT02310646|B3|Baseline|Total|Total of all reporting groups
11608|NCT02310646|B2|Baseline|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
11609|NCT02310646|B1|Baseline|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
11610|NCT02310646|P2|Participant Flow|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11611|NCT02310646|P1|Participant Flow|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11612|NCT02310646|O8|Outcome|Prefer Gel - Not at All Important Factor|Subjects who prefer gel
11613|NCT02310646|O7|Outcome|Prefer Gel - Not Very Important Factor|Subjects who prefer gel
11620|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
11621|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
11622|NCT02310646|O2|Outcome|All Subjects Gel|Subject assessments of Daivobet® gel compared to latest topical treatment (CLTT analysis set).
11623|NCT02310646|O1|Outcome|All Subjects Foam|Subject assessments of LEO 90100 aerosol foam compared to latest topical treatment (CLTT analysis set).
11624|NCT02310646|O3|Outcome|Daivobet® Gel|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline.~Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group."
11625|NCT02310646|O2|Outcome|LEO 90100 Aerosol Foam|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to Baseline.~Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 aerosol foam assessments from the foam-gel group as well as the gel-foam group."
11626|NCT02310646|O1|Outcome|Latest Topical Treatment|Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline. Assessments of last topical treatment (TPUQ tool) at baseline.
11627|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
11628|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
11629|NCT02310646|O3|Outcome|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
11630|NCT02310646|O2|Outcome|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
11631|NCT02310646|O1|Outcome|All Randomised Subjects|All randomised subjects (foam – gel and gel – foam)
11632|NCT02310646|E2|Reported Event|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11633|NCT02310646|E1|Reported Event|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
11634|NCT02310568|B6|Baseline|Total|Total of all reporting groups
11635|NCT02310568|B5|Baseline|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11636|NCT02310568|B4|Baseline|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11637|NCT02310568|B3|Baseline|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
11638|NCT02310568|B2|Baseline|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
11639|NCT02310568|B1|Baseline|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11640|NCT02310568|P5|Participant Flow|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11641|NCT02310568|P4|Participant Flow|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11642|NCT02310568|P3|Participant Flow|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
11643|NCT02310568|P2|Participant Flow|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
11644|NCT02310568|P1|Participant Flow|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
11645|NCT02310568|O6|Outcome|PF­06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11646|NCT02310568|O5|Outcome|PF­06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11647|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11648|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11649|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11650|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11863|NCT02305329|P1|Participant Flow|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
11651|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11652|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11653|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11654|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11655|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11656|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11657|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11658|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11659|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11660|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11661|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11662|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11663|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11664|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11665|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11666|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11667|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11668|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11669|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11670|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11671|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11672|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11673|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11674|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11675|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11676|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11677|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11678|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11679|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11680|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11681|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11682|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11683|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11684|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11685|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11686|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11687|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11688|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11864|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
11689|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11690|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11691|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11692|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11693|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11694|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11695|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11696|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11697|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11698|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11699|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11700|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11701|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11702|NCT02310568|O1|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11703|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11704|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11705|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11706|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11707|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11708|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11709|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11710|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11711|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11712|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
11713|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
11714|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
11715|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11716|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
11717|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
11718|NCT02310568|E3|Reported Event|PF-06372865 7.5 mg|All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
11719|NCT02310568|E2|Reported Event|PF-06372865 2.5 mg|All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
11720|NCT02310568|E1|Reported Event|Placebo|All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
11721|NCT02310126|B3|Baseline|Total|Total of all reporting groups
11722|NCT02310126|B2|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
11723|NCT02310126|B1|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.
11724|NCT02310126|P2|Participant Flow|Etafilcon A(Sphere)/Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
11725|NCT02310126|P1|Participant Flow|Etafilcon A(Multi-focal)/Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.
11865|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
11726|NCT02310126|O2|Outcome|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
11727|NCT02310126|O1|Outcome|Etafilcon A(Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
11728|NCT02310126|E2|Reported Event|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
11729|NCT02310126|E1|Reported Event|Etafilcon A (Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
11730|NCT02309294|B1|Baseline|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11731|NCT02309294|P1|Participant Flow|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11732|NCT02309294|O1|Outcome|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11733|NCT02309294|E1|Reported Event|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
11734|NCT02309112|B4|Baseline|Total|Total of all reporting groups
11735|NCT02309112|B3|Baseline|Yoga Group C: Maximum Exposure|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11736|NCT02309112|B2|Baseline|Yoga Group B: Medium Exposure|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11737|NCT02309112|B1|Baseline|Yoga Group A: Minimum Exposure|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11738|NCT02309112|P3|Participant Flow|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11739|NCT02309112|P2|Participant Flow|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11740|NCT02309112|P1|Participant Flow|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11741|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
11742|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11838|NCT02307123|P1|Participant Flow|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11743|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11744|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
11745|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11746|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11747|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|"Maximum Yoga Dose~Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)"
11748|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11749|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11750|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
11751|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11752|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11753|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
11754|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
11755|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
11756|NCT02309112|O1|Outcome|Eligible Participants|The group of eligible participants who agreed to be randomized to ono of three yoga groups.
11757|NCT02309112|E3|Reported Event|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11758|NCT02309112|E2|Reported Event|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11759|NCT02309112|E1|Reported Event|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
11760|NCT02308787|B1|Baseline|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11866|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
11761|NCT02308787|P1|Participant Flow|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11762|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11763|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11764|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11765|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11766|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11767|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11768|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11769|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11770|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11771|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11772|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11773|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11774|NCT02308787|E1|Reported Event|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
11775|NCT02308748|B1|Baseline|All Study Participants|Participants who were randomized to receive either dofetilide alone, dofetilide + mexiletine, dofetilide + lidocaine, moxifloxacin + diltiazem or placebo.
11776|NCT02308748|P10|Participant Flow|C-B-D-E-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment A (dofetilide)"
11777|NCT02308748|P9|Participant Flow|B-E-C-A-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem)"
11778|NCT02308748|P8|Participant Flow|A-E-D-B-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine)"
11779|NCT02308748|P7|Participant Flow|E-B-A-C-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem)"
11780|NCT02308748|P6|Participant Flow|D-A-C-E-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment B (dofetilide + lidocaine)"
11781|NCT02308748|P5|Participant Flow|E-A-B-D-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine)"
11782|NCT02308748|P4|Participant Flow|D-C-A-B-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment E (placebo)"
11783|NCT02308748|P3|Participant Flow|C-D-B-A-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment E (placebo)"
11784|NCT02308748|P2|Participant Flow|B-C-E-D-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide)"
11867|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
11785|NCT02308748|P1|Participant Flow|A-D-E-C-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine)"
11786|NCT02308748|O2|Outcome|Moxifloxacin + Diltiazem|Subjects that completed placebo and moxifloxacin + diltiazem interventions
11787|NCT02308748|O1|Outcome|Moxifloxacin Alone|Subjects that completed placebo and moxifloxacin alone interventions
11788|NCT02308748|O3|Outcome|Dofetilide + Lidocaine|Subjects that completed placebo and dofetilide + lidocaine interventions
11789|NCT02308748|O2|Outcome|Dofetilide + Mexiletine|Subjects that completed placebo and dofetilide + mexiletine interventions
11790|NCT02308748|O1|Outcome|Dofetilide Alone|Subjects that completed placebo and dofetilide alone interventions
11791|NCT02308748|E5|Reported Event|Placebo|"Placebo (#2 gelcap and intravenous saline)~Placebo: Placebo (#2 Gelcap or IV saline)"
11792|NCT02308748|E4|Reported Event|Moxifloxacin + Diltiazem|"Moxifloxacin with and without diltiazem.~Moxifloxacin: • 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)~2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~Diltiazem: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes"
11793|NCT02308748|E3|Reported Event|Dofetilide + Mexiletine|"Dofetilide combined with mexiletine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Mexiletine: • 8 am: weight x 4 mg/kg~12 pm (noon): Same as at 8 am~5:30 pm: Same as at 8 am"
11794|NCT02308748|E2|Reported Event|Dofetilide + Lidocaine|"Dofetilide combined with lidocaine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Lidocaine: • 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes~2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes~7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
11795|NCT02308748|E1|Reported Event|Dofetilide|"Dofetilide alone arm~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg"
11796|NCT02308371|B3|Baseline|Total|Total of all reporting groups
11797|NCT02308371|B2|Baseline|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
11798|NCT02308371|B1|Baseline|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
11799|NCT02308371|P2|Participant Flow|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11800|NCT02308371|P1|Participant Flow|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV> 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
11801|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11802|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11803|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11804|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11805|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11806|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11807|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
11839|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11840|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11808|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
11809|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11810|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11811|NCT02308371|E2|Reported Event|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
11812|NCT02308371|E1|Reported Event|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
11813|NCT02307318|B1|Baseline|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11814|NCT02307318|P1|Participant Flow|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11815|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11816|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11817|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11818|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11819|NCT02307318|E1|Reported Event|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
11820|NCT02307266|B4|Baseline|Total|Total of all reporting groups
11821|NCT02307266|B3|Baseline|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11822|NCT02307266|B2|Baseline|Standard of Care|Subjects received standard-of-care instructions only.
11823|NCT02307266|B1|Baseline|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11824|NCT02307266|P3|Participant Flow|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11825|NCT02307266|P2|Participant Flow|Standard of Care|Subjects received standard-of-care instructions only.
11826|NCT02307266|P1|Participant Flow|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11827|NCT02307266|O3|Outcome|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11828|NCT02307266|O2|Outcome|Standard of Care|Subjects received standard-of-care instructions only.
11829|NCT02307266|O1|Outcome|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11830|NCT02307266|E3|Reported Event|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
11831|NCT02307266|E2|Reported Event|Standard of Care|Subjects received standard-of-care instructions only.
11832|NCT02307266|E1|Reported Event|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
11833|NCT02307188|B1|Baseline|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter."
11834|NCT02307188|P1|Participant Flow|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions."
11835|NCT02307188|O1|Outcome|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic ACT levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).~Due to the paucity of information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further."
11836|NCT02307188|E1|Reported Event|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~No adverse events related to this catheter were noted."
11837|NCT02307123|B1|Baseline|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11868|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
11841|NCT02307123|E1|Reported Event|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
11842|NCT02306928|B1|Baseline|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11843|NCT02306928|P1|Participant Flow|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11844|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11845|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11846|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11847|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11848|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
11849|NCT02306928|E1|Reported Event|Piperacillin Pharmacokinetics|Serious and non-serious adverse advents were not collected.
11850|NCT02305446|B1|Baseline|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11851|NCT02305446|P1|Participant Flow|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11852|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11853|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11854|NCT02305446|E1|Reported Event|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
11855|NCT02305329|B5|Baseline|Total|Total of all reporting groups
11856|NCT02305329|B4|Baseline|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
11857|NCT02305329|B3|Baseline|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
11858|NCT02305329|B2|Baseline|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
11859|NCT02305329|B1|Baseline|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
11860|NCT02305329|P4|Participant Flow|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
11861|NCT02305329|P3|Participant Flow|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
11862|NCT02305329|P2|Participant Flow|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
11869|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
11881|NCT02305329|E3|Reported Event|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
11882|NCT02305329|E2|Reported Event|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
11883|NCT02305329|E1|Reported Event|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
11884|NCT02305316|B3|Baseline|Total|Total of all reporting groups
11885|NCT02305316|B2|Baseline|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11886|NCT02305316|B1|Baseline|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11887|NCT02305316|P2|Participant Flow|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11888|NCT02305316|P1|Participant Flow|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
11889|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11890|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11891|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11892|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11893|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11894|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11895|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11896|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11897|NCT02305316|E2|Reported Event|BIA 9-1067 Micronized|BIA 9-1067 micronized.
11898|NCT02305316|E1|Reported Event|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
11899|NCT02305277|B7|Baseline|Total|Total of all reporting groups
11900|NCT02305277|B6|Baseline|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11901|NCT02305277|B5|Baseline|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11902|NCT02305277|B4|Baseline|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11903|NCT02305277|B3|Baseline|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11904|NCT02305277|B2|Baseline|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11905|NCT02305277|B1|Baseline|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11906|NCT02305277|P6|Participant Flow|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11907|NCT02305277|P5|Participant Flow|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11908|NCT02305277|P4|Participant Flow|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11909|NCT02305277|P3|Participant Flow|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11910|NCT02305277|P2|Participant Flow|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11911|NCT02305277|P1|Participant Flow|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
11912|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11913|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11914|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11915|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11916|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11917|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11918|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11919|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11920|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11921|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11922|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11923|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11924|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11925|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11926|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11927|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11928|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11929|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11930|NCT02305277|E6|Reported Event|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
11931|NCT02305277|E5|Reported Event|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
11932|NCT02305277|E4|Reported Event|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
11933|NCT02305277|E3|Reported Event|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
11934|NCT02305277|E2|Reported Event|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
11935|NCT02305277|E1|Reported Event|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
11936|NCT02305017|B3|Baseline|Total|Total of all reporting groups
11937|NCT02305017|B2|Baseline|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11938|NCT02305017|B1|Baseline|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11939|NCT02305017|P2|Participant Flow|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11940|NCT02305017|P1|Participant Flow|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
11941|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
11942|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
11943|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
11944|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
11945|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
11946|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079
11947|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
11948|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
11949|NCT02305017|E2|Reported Event|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
11950|NCT02305017|E1|Reported Event|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
11951|NCT02304926|B3|Baseline|Total|Total of all reporting groups
11952|NCT02304926|B2|Baseline|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11953|NCT02304926|B1|Baseline|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11954|NCT02304926|P2|Participant Flow|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11955|NCT02304926|P1|Participant Flow|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11956|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11957|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11958|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11959|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11960|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11961|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11962|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11963|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11964|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11965|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11966|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11967|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11968|NCT02304926|O2|Outcome|Ezetimibe|"19 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11969|NCT02304926|O1|Outcome|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11970|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11971|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11972|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
12342|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
11973|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11974|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11975|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11976|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11977|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11978|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11979|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11980|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11981|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11982|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11983|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11984|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11985|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11986|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
12343|NCT02295020|O1|Outcome|Standard Treatment Only.|Standard treatment only such as NSAIDs and injections.
11987|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11988|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11989|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11990|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11991|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11992|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11993|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11994|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11995|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11996|NCT02304926|E2|Reported Event|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11997|NCT02304926|E1|Reported Event|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
11998|NCT02303743|B3|Baseline|Total|Total of all reporting groups
11999|NCT02303743|B2|Baseline|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
12000|NCT02303743|B1|Baseline|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
12001|NCT02303743|P2|Participant Flow|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
12344|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
12002|NCT02303743|P1|Participant Flow|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
12003|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
12004|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
12005|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
12006|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
12007|NCT02303743|E2|Reported Event|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
12008|NCT02303743|E1|Reported Event|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
12009|NCT02303704|B3|Baseline|Total|Total of all reporting groups
12010|NCT02303704|B2|Baseline|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12011|NCT02303704|B1|Baseline|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts
12012|NCT02303704|P2|Participant Flow|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12013|NCT02303704|P1|Participant Flow|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12014|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12015|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12016|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12017|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12018|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12019|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12020|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12021|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12022|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12023|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12024|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12025|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12345|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
12026|NCT02303704|E2|Reported Event|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
12027|NCT02303704|E1|Reported Event|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
12028|NCT02302365|B1|Baseline|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12029|NCT02302365|P1|Participant Flow|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12030|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12031|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12032|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12033|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12034|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12035|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12036|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12037|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12038|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12039|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12040|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12041|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12042|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12043|NCT02302365|E1|Reported Event|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
12044|NCT02301429|B1|Baseline|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
12045|NCT02301429|P1|Participant Flow|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
12046|NCT02301429|O1|Outcome|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
12047|NCT02301429|E1|Reported Event|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
12048|NCT02301377|B3|Baseline|Total|Total of all reporting groups
12049|NCT02301377|B2|Baseline|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
12050|NCT02301377|B1|Baseline|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12051|NCT02301377|P2|Participant Flow|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
12052|NCT02301377|P1|Participant Flow|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12053|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
14981|NCT02248818|P8|Participant Flow|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
12054|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12055|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
12056|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12057|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
12058|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12059|NCT02301377|E2|Reported Event|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
12060|NCT02301377|E1|Reported Event|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
12061|NCT02301169|B3|Baseline|Total|Total of all reporting groups
12062|NCT02301169|B2|Baseline|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12063|NCT02301169|B1|Baseline|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12064|NCT02301169|P2|Participant Flow|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12065|NCT02301169|P1|Participant Flow|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12066|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12067|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12068|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12069|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12070|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12071|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12072|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12073|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12074|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
17836|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
12075|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12076|NCT02301169|E2|Reported Event|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
12077|NCT02301169|E1|Reported Event|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
12078|NCT02300311|B3|Baseline|Total|Total of all reporting groups
12079|NCT02300311|B2|Baseline|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12080|NCT02300311|B1|Baseline|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12081|NCT02300311|P2|Participant Flow|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12082|NCT02300311|P1|Participant Flow|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12083|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12084|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12085|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12086|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12087|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12088|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12089|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
12090|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12091|NCT02300311|E2|Reported Event|Finalgon® Cream (Nicoboxil/ Nonivamide)|Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12092|NCT02300311|E1|Reported Event|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
12093|NCT02300129|B1|Baseline|All Study Participants (Intent To Treat Population)|One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
12094|NCT02300129|P4|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
12095|NCT02300129|P3|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
12127|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12160|NCT02299869|P4|Participant Flow|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12096|NCT02300129|P2|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
12097|NCT02300129|P1|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
12098|NCT02300129|O2|Outcome|Period 2 Placebo Gel Cross-over|CD07805/47 placebo gel
12099|NCT02300129|O1|Outcome|Period 2 CD07805/47 0.5% Gel Cross-over|CD07805/47 0.5% gel (Brimonidine tartrate)
12100|NCT02300129|E6|Reported Event|Period 2 Placebo Gel Cross Over|Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
12101|NCT02300129|E5|Reported Event|Period 2 CD07805/47 0.5% Gel Cross Over|Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
12102|NCT02300129|E4|Reported Event|Period 1 CD07805/47 0.5% Gel Cross-over|Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
12103|NCT02300129|E3|Reported Event|Period 1 Placebo Gel Split Face|Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
12104|NCT02300129|E2|Reported Event|Period 1 CD07805/47 0.5% Gel Split Face|Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
12105|NCT02300129|E1|Reported Event|Period 1 Placebo Gel Cross Over|Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
12106|NCT02300025|B5|Baseline|Total|Total of all reporting groups
12107|NCT02300025|B4|Baseline|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12108|NCT02300025|B3|Baseline|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12109|NCT02300025|B2|Baseline|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12110|NCT02300025|B1|Baseline|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12111|NCT02300025|P4|Participant Flow|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12112|NCT02300025|P3|Participant Flow|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12113|NCT02300025|P2|Participant Flow|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12114|NCT02300025|P1|Participant Flow|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
12115|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12116|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12117|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12118|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12119|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12120|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12121|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12122|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12123|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12124|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12125|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12126|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12277|NCT02296931|B3|Baseline|Total|Total of all reporting groups
12128|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12129|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12130|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12131|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12132|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12133|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12134|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12135|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12136|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12137|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12138|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12139|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12140|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12141|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12142|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12143|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12144|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12145|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12146|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12147|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12148|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12149|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12150|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12151|NCT02300025|E4|Reported Event|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12152|NCT02300025|E3|Reported Event|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12153|NCT02300025|E2|Reported Event|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12154|NCT02300025|E1|Reported Event|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
12155|NCT02299869|B5|Baseline|Total|Total of all reporting groups
12156|NCT02299869|B4|Baseline|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12157|NCT02299869|B3|Baseline|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12158|NCT02299869|B2|Baseline|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12159|NCT02299869|B1|Baseline|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
17837|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
12161|NCT02299869|P3|Participant Flow|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12162|NCT02299869|P2|Participant Flow|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12163|NCT02299869|P1|Participant Flow|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12164|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12165|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12166|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12167|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12168|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12169|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12170|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12171|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12172|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12173|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12174|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12175|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12176|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12177|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12178|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12179|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12180|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12181|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12182|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12183|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
12184|NCT02299869|E1|Reported Event|Overall Participants|Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).
12185|NCT02299635|B1|Baseline|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12186|NCT02299635|P1|Participant Flow|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12187|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12188|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12189|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12190|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12191|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12192|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12193|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
14982|NCT02248818|P7|Participant Flow|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
12194|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12195|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12196|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12197|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12198|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12199|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12200|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12201|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12202|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12203|NCT02299635|E1|Reported Event|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
12204|NCT02299427|B3|Baseline|Total|Total of all reporting groups
12205|NCT02299427|B2|Baseline|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
12206|NCT02299427|B1|Baseline|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
12207|NCT02299427|P2|Participant Flow|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
12208|NCT02299427|P1|Participant Flow|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
12209|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
12210|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
12211|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
12212|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
12213|NCT02299427|E2|Reported Event|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
12214|NCT02299427|E1|Reported Event|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks~There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis."
12215|NCT02299349|B3|Baseline|Total|Total of all reporting groups
12216|NCT02299349|B2|Baseline|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
12217|NCT02299349|B1|Baseline|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
12218|NCT02299349|P2|Participant Flow|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
12219|NCT02299349|P1|Participant Flow|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
12220|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
14983|NCT02248818|P6|Participant Flow|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
12221|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
12222|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
12223|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
12224|NCT02299349|E2|Reported Event|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
12225|NCT02299349|E1|Reported Event|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
12226|NCT02299258|B3|Baseline|Total|Total of all reporting groups
12227|NCT02299258|B2|Baseline|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
12228|NCT02299258|B1|Baseline|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
12229|NCT02299258|P2|Participant Flow|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
12230|NCT02299258|P1|Participant Flow|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
12231|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
12232|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
12233|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
12234|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
12235|NCT02299258|E2|Reported Event|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
12236|NCT02299258|E1|Reported Event|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
12237|NCT02298868|B1|Baseline|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12238|NCT02298868|P1|Participant Flow|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12239|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12240|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12241|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12242|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12243|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12244|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12245|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12246|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12247|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12248|NCT02298868|E1|Reported Event|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
12249|NCT02298361|B4|Baseline|Total|Total of all reporting groups
12250|NCT02298361|B3|Baseline|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12251|NCT02298361|B2|Baseline|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12252|NCT02298361|B1|Baseline|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12253|NCT02298361|P3|Participant Flow|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12254|NCT02298361|P2|Participant Flow|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12255|NCT02298361|P1|Participant Flow|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12256|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12257|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12258|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12259|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12260|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12261|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12262|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12263|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12264|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12265|NCT02298361|E3|Reported Event|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
12266|NCT02298361|E2|Reported Event|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
12267|NCT02298361|E1|Reported Event|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
12268|NCT02297841|B1|Baseline|HRIPT|Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
12269|NCT02297841|P1|Participant Flow|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
12270|NCT02297841|O1|Outcome|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
12271|NCT02297841|E1|Reported Event|HRIPT|Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel lubricant
12272|NCT02297308|B1|Baseline|SoloPath Sheath|The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
12273|NCT02297308|P1|Participant Flow|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
12274|NCT02297308|O1|Outcome|SoloPath Sheath|Rate of VARC-2 defined access site bleeding complications.
12275|NCT02297308|O1|Outcome|SoloPath Sheath|Vascular Complications
12276|NCT02297308|E1|Reported Event|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
12278|NCT02296931|B2|Baseline|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
12279|NCT02296931|B1|Baseline|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
12280|NCT02296931|P2|Participant Flow|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
12281|NCT02296931|P1|Participant Flow|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
12282|NCT02296931|O2|Outcome|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
12283|NCT02296931|O1|Outcome|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
12284|NCT02296931|E2|Reported Event|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
12285|NCT02296931|E1|Reported Event|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
12286|NCT02295774|B1|Baseline|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
12287|NCT02295774|P1|Participant Flow|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
12288|NCT02295774|O1|Outcome|Group A|"This is a crossover study. Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
12289|NCT02295774|E1|Reported Event|Group A|"This is a crossover study.~Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks.~Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
12290|NCT02295644|B5|Baseline|Total|Total of all reporting groups
12291|NCT02295644|B4|Baseline|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12292|NCT02295644|B3|Baseline|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12293|NCT02295644|B2|Baseline|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12294|NCT02295644|B1|Baseline|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12295|NCT02295644|P4|Participant Flow|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12296|NCT02295644|P3|Participant Flow|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12297|NCT02295644|P2|Participant Flow|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12298|NCT02295644|P1|Participant Flow|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12299|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12300|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12301|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12302|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12303|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12304|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12305|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12306|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12307|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12308|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12309|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12310|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12311|NCT02295644|E4|Reported Event|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12312|NCT02295644|E3|Reported Event|C(0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12313|NCT02295644|E2|Reported Event|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12314|NCT02295644|E1|Reported Event|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
12315|NCT02295020|B3|Baseline|Total|Total of all reporting groups
12316|NCT02295020|B2|Baseline|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
12317|NCT02295020|B1|Baseline|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12318|NCT02295020|P2|Participant Flow|Standard Treatment Plus Bioskin Ten-7.|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
12319|NCT02295020|P1|Participant Flow|Standard Treatment Only.|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
12320|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
12321|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
12322|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
12323|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
12324|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
12325|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
12326|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
12327|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12328|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
12329|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12330|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
12331|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12332|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace
12333|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12334|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
12335|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
12336|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
12337|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12338|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
12339|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12340|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
12341|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
12346|NCT02295020|E2|Reported Event|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
12347|NCT02295020|E1|Reported Event|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
12348|NCT02294773|B3|Baseline|Total|Total of all reporting groups
12349|NCT02294773|B2|Baseline|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12350|NCT02294773|B1|Baseline|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12351|NCT02294773|P2|Participant Flow|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12352|NCT02294773|P1|Participant Flow|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12353|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12354|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12355|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12356|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12357|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12358|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12359|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12360|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12396|NCT02293538|P1|Participant Flow|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12493|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
12361|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12362|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12363|NCT02294773|E2|Reported Event|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12364|NCT02294773|E1|Reported Event|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
12365|NCT02294604|B4|Baseline|Total|Total of all reporting groups
12366|NCT02294604|B3|Baseline|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12367|NCT02294604|B2|Baseline|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12368|NCT02294604|B1|Baseline|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12369|NCT02294604|P3|Participant Flow|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12370|NCT02294604|P2|Participant Flow|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12371|NCT02294604|P1|Participant Flow|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12372|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12373|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12374|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12375|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12376|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12377|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12378|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12379|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12380|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12381|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12382|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12383|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12384|NCT02294604|E3|Reported Event|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
12385|NCT02294604|E2|Reported Event|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
12386|NCT02294604|E1|Reported Event|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
12387|NCT02294019|B1|Baseline|Ibuprofen|All participants who purchased at least 1 carton of study medication.
12388|NCT02294019|P1|Participant Flow|Ibuprofen|All participants who purchased at least 1 carton of study medication.
12389|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
12390|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
12391|NCT02294019|E1|Reported Event|Ibuprofen (Safety Population)|Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
12392|NCT02293538|B3|Baseline|Total|Total of all reporting groups
12393|NCT02293538|B2|Baseline|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12394|NCT02293538|B1|Baseline|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12395|NCT02293538|P2|Participant Flow|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12611|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12397|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12398|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12399|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12400|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12401|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12402|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12403|NCT02293538|O1|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12404|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12405|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12406|NCT02293538|E2|Reported Event|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12407|NCT02293538|E1|Reported Event|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
12408|NCT02292433|B4|Baseline|Total|Total of all reporting groups
12409|NCT02292433|B3|Baseline|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12410|NCT02292433|B2|Baseline|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12411|NCT02292433|B1|Baseline|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12412|NCT02292433|P3|Participant Flow|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12413|NCT02292433|P2|Participant Flow|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12414|NCT02292433|P1|Participant Flow|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
12415|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12416|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12417|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12418|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12419|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12420|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12421|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12422|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12423|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12424|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12425|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12426|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12427|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12428|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12429|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12430|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12431|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12432|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12433|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12434|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12435|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12436|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12437|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12438|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12439|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12492|NCT02291510|P1|Participant Flow|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12612|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12440|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12441|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12442|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12443|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12444|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12445|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12446|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12447|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12448|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12449|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12450|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12451|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12452|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12453|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12454|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12455|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12456|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12457|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12458|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12459|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12460|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12461|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12462|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12463|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
17838|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
12464|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12465|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12466|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12467|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12468|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12469|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12470|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12471|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12472|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12473|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12474|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12475|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12476|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12477|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12478|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12479|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12480|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12481|NCT02292433|E3|Reported Event|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
12482|NCT02292433|E2|Reported Event|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
12483|NCT02292433|E1|Reported Event|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
12484|NCT02291510|B5|Baseline|Total|Total of all reporting groups
12485|NCT02291510|B4|Baseline|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12486|NCT02291510|B3|Baseline|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12487|NCT02291510|B2|Baseline|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12488|NCT02291510|B1|Baseline|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12489|NCT02291510|P4|Participant Flow|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12490|NCT02291510|P3|Participant Flow|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12491|NCT02291510|P2|Participant Flow|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
12494|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
12495|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12496|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12497|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
12498|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
12499|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12500|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12501|NCT02291510|E4|Reported Event|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
12502|NCT02291510|E3|Reported Event|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
12503|NCT02291510|E2|Reported Event|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12504|NCT02291510|E1|Reported Event|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
12505|NCT02291419|B3|Baseline|Total|Total of all reporting groups
12506|NCT02291419|B2|Baseline|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12507|NCT02291419|B1|Baseline|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12508|NCT02291419|P2|Participant Flow|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12509|NCT02291419|P1|Participant Flow|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12510|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12511|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12512|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12513|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12514|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12515|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12516|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12517|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12518|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12519|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12520|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12521|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12522|NCT02291419|E2|Reported Event|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
12523|NCT02291419|E1|Reported Event|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
12524|NCT02290509|B3|Baseline|Total|Total of all reporting groups
12525|NCT02290509|B2|Baseline|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12526|NCT02290509|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12527|NCT02290509|P2|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12528|NCT02290509|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12529|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12530|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12531|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12532|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12565|NCT02289742|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
12533|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12534|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12535|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12536|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12537|NCT02290509|E2|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
12538|NCT02290509|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
12539|NCT02289755|B1|Baseline|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
12540|NCT02289755|P1|Participant Flow|ALLN-177|ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
12541|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
12542|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
12543|NCT02289755|E1|Reported Event|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
12544|NCT02289742|B3|Baseline|Total|Total of all reporting groups
12545|NCT02289742|B2|Baseline|Astigmats|Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
12546|NCT02289742|B1|Baseline|Presbyopes|Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
12547|NCT02289742|P4|Participant Flow|Astigmats Sphere/Toric|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
12548|NCT02289742|P3|Participant Flow|Astigmats Toric/Sphere|Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
12549|NCT02289742|P2|Participant Flow|Presbyopes Sphere/MF|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
12550|NCT02289742|P1|Participant Flow|Presbyopes MF/Sphere|Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
12551|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
12552|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)
12553|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
12554|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
12555|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
12556|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
12557|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
12558|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
12559|NCT02289742|E7|Reported Event|Astigmats / Sphere Second Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
12560|NCT02289742|E6|Reported Event|Astigmats / Sphere First Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
12561|NCT02289742|E5|Reported Event|Astigmats / Toric|All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
12562|NCT02289742|E4|Reported Event|Presbyopes / Sphere Second Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
12563|NCT02289742|E3|Reported Event|Presbyopes / Sphere First Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
12564|NCT02289742|E2|Reported Event|Presbyopes / Multifocal|All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
12567|NCT02289105|B2|Baseline|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12568|NCT02289105|B1|Baseline|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12569|NCT02289105|P2|Participant Flow|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12570|NCT02289105|P1|Participant Flow|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12571|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12572|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12573|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12574|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12575|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12576|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12577|NCT02289105|E2|Reported Event|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
12578|NCT02289105|E1|Reported Event|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
12579|NCT02289079|B3|Baseline|Total|Total of all reporting groups
12580|NCT02289079|B2|Baseline|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12581|NCT02289079|B1|Baseline|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12582|NCT02289079|P2|Participant Flow|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12583|NCT02289079|P1|Participant Flow|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12584|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12585|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12586|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12587|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12588|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12589|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12590|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12591|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12592|NCT02289079|E2|Reported Event|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
12593|NCT02289079|E1|Reported Event|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
12594|NCT02288364|B3|Baseline|Total|Total of all reporting groups
12595|NCT02288364|B2|Baseline|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12596|NCT02288364|B1|Baseline|1% Lidocaine|1% Lidocaine alone.
12597|NCT02288364|P2|Participant Flow|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12598|NCT02288364|P1|Participant Flow|1% Lidocaine|1% Lidocaine alone.
12599|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12600|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12601|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12602|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12603|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12604|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12605|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12606|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12607|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12608|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12609|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12613|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12614|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12615|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12616|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12617|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12618|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
12619|NCT02288364|E2|Reported Event|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
12620|NCT02288364|E1|Reported Event|1% Lidocaine|1% Lidocaine alone.
12621|NCT02288312|B4|Baseline|Total|Total of all reporting groups
12622|NCT02288312|B3|Baseline|Sequence C|Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
12623|NCT02288312|B2|Baseline|Sequence B|Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
12624|NCT02288312|B1|Baseline|Sequence A|Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
12625|NCT02288312|P3|Participant Flow|Group C|"Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)~Washout periods - 7 days between dosing days"
12626|NCT02288312|P2|Participant Flow|Group B|"Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)~Washout periods - 7 days between dosing days"
12627|NCT02288312|P1|Participant Flow|Group A|"Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)~Washout periods - 7 days between dosing days"
12628|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
12629|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12630|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12631|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
12632|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12633|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12634|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
12635|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12636|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12637|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
12638|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12639|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12640|NCT02288312|E3|Reported Event|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
12641|NCT02288312|E2|Reported Event|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12642|NCT02288312|E1|Reported Event|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
12643|NCT02288273|B3|Baseline|Total|Total of all reporting groups
12644|NCT02288273|B2|Baseline|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12645|NCT02288273|B1|Baseline|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
12646|NCT02288273|P2|Participant Flow|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12647|NCT02288273|P1|Participant Flow|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
12648|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12649|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12650|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12651|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12652|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12653|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12654|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12655|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12656|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12657|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12658|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12659|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12660|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12661|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12662|NCT02288273|E2|Reported Event|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
12663|NCT02288273|E1|Reported Event|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
12664|NCT02287779|B9|Baseline|Total|Total of all reporting groups
12665|NCT02287779|B8|Baseline|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12666|NCT02287779|B7|Baseline|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12667|NCT02287779|B6|Baseline|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12668|NCT02287779|B5|Baseline|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12669|NCT02287779|B4|Baseline|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12670|NCT02287779|B3|Baseline|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
12671|NCT02287779|B2|Baseline|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
12672|NCT02287779|B1|Baseline|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
12673|NCT02287779|P8|Participant Flow|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12674|NCT02287779|P7|Participant Flow|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12675|NCT02287779|P6|Participant Flow|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12676|NCT02287779|P5|Participant Flow|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12677|NCT02287779|P4|Participant Flow|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12678|NCT02287779|P3|Participant Flow|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
12679|NCT02287779|P2|Participant Flow|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
12680|NCT02287779|P1|Participant Flow|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12681|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12682|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12683|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12684|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12685|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12686|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
12687|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
12688|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12689|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12690|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12691|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12692|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12693|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12694|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12695|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12696|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12697|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12698|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12699|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12700|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12701|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12702|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12703|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12704|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12705|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12706|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12707|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12708|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12709|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12710|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12711|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12712|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12713|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12714|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12715|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12716|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12717|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12718|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12719|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12720|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12721|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12722|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12723|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12724|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12725|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12726|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12727|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12728|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12729|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12730|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12731|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12732|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12733|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12734|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12735|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12736|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
12737|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12738|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12739|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12740|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12741|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12742|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12743|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12744|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12745|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12746|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12747|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12748|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12749|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12750|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12751|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12752|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12753|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12754|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12755|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12756|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12757|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12758|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
12759|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12760|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12761|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12762|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12763|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12764|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12765|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12766|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
12767|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12768|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12769|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12770|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12771|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12772|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12773|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12774|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12775|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12776|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12777|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12778|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12779|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12780|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12781|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12782|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
12783|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12784|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12785|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12786|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12787|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12788|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12789|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12790|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
12791|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12792|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12793|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12794|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12795|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12796|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12797|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12798|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
12799|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12800|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12801|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12802|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12803|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12804|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
17839|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
12805|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12806|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
12807|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
12808|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12809|NCT02287779|E8|Reported Event|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
12810|NCT02287779|E7|Reported Event|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
12811|NCT02287779|E6|Reported Event|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
12812|NCT02287779|E5|Reported Event|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
12813|NCT02287779|E4|Reported Event|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
12814|NCT02287779|E3|Reported Event|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
12815|NCT02287779|E2|Reported Event|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
12816|NCT02287779|E1|Reported Event|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
12817|NCT02287623|B3|Baseline|Total|Total of all reporting groups
12818|NCT02287623|B2|Baseline|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12819|NCT02287623|B1|Baseline|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12820|NCT02287623|P2|Participant Flow|Bupivacaine TAP|Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
12821|NCT02287623|P1|Participant Flow|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline."
12822|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12823|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12824|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12825|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12826|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12827|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12828|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12829|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12830|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12831|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12832|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12833|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12834|NCT02287623|E2|Reported Event|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
12835|NCT02287623|E1|Reported Event|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
12836|NCT02287610|B1|Baseline|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12837|NCT02287610|P1|Participant Flow|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12838|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12839|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12840|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12841|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12842|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12843|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12844|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12845|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12846|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12847|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12848|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12849|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12850|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12851|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12852|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12853|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12854|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12855|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12856|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12857|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12858|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12859|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12860|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12861|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12862|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12863|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12864|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12865|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12866|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12867|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12868|NCT02287610|E1|Reported Event|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
12869|NCT02287415|B1|Baseline|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12870|NCT02287415|P1|Participant Flow|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12871|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12872|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12873|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12874|NCT02287415|E1|Reported Event|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
12875|NCT02287402|B1|Baseline|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12876|NCT02287402|P1|Participant Flow|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12877|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12878|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12879|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12880|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12881|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12882|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12883|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12884|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12885|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12886|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12887|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12888|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12889|NCT02287402|E1|Reported Event|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
12890|NCT02286518|B15|Baseline|Total|Total of all reporting groups
12891|NCT02286518|B14|Baseline|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12892|NCT02286518|B13|Baseline|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13216|NCT02283840|E4|Reported Event|Reference 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
12893|NCT02286518|B12|Baseline|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12894|NCT02286518|B11|Baseline|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12895|NCT02286518|B10|Baseline|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12896|NCT02286518|B9|Baseline|Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.
12897|NCT02286518|B8|Baseline|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
12898|NCT02286518|B7|Baseline|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12899|NCT02286518|B6|Baseline|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12900|NCT02286518|B5|Baseline|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12901|NCT02286518|B4|Baseline|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12902|NCT02286518|B3|Baseline|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12903|NCT02286518|B2|Baseline|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12904|NCT02286518|B1|Baseline|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12905|NCT02286518|P14|Participant Flow|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12906|NCT02286518|P13|Participant Flow|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12907|NCT02286518|P12|Participant Flow|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12908|NCT02286518|P11|Participant Flow|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12909|NCT02286518|P10|Participant Flow|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12910|NCT02286518|P9|Participant Flow|Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.
12911|NCT02286518|P8|Participant Flow|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
12912|NCT02286518|P7|Participant Flow|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12913|NCT02286518|P6|Participant Flow|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12914|NCT02286518|P5|Participant Flow|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12915|NCT02286518|P4|Participant Flow|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12916|NCT02286518|P3|Participant Flow|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12917|NCT02286518|P2|Participant Flow|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12918|NCT02286518|P1|Participant Flow|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12919|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12920|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12921|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12922|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12923|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12924|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12925|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12998|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12926|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12927|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12928|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12929|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12930|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12931|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12932|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12933|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12934|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12935|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12936|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12937|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12938|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12939|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12940|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12941|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12942|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12943|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12944|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12945|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12946|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12947|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12948|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12949|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12950|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12951|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12952|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12953|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12954|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12955|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12956|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12957|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12958|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12959|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12960|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12961|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12962|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12963|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12964|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12965|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12966|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12967|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12968|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12969|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12970|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12971|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12972|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12973|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12974|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12975|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12976|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12977|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12978|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12979|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12980|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12981|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12982|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12983|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12984|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12985|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12986|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12987|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12988|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
12989|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12990|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12991|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
12992|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12993|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
12994|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12995|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12996|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
12997|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
12999|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13000|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13001|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13002|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13003|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13004|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13005|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13006|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13007|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13008|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13009|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13010|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13011|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13012|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13013|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13014|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13015|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13016|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13017|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13018|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13019|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13020|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13021|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13022|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13023|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13024|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13025|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13026|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13027|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13028|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13029|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13030|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13031|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13032|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13033|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13108|NCT02284880|E6|Reported Event|After Follow-up Visit|After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
13034|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13035|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13036|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13037|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13038|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13039|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13040|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13041|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13042|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13043|NCT02286518|E14|Reported Event|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13044|NCT02286518|E13|Reported Event|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
13045|NCT02286518|E12|Reported Event|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13046|NCT02286518|E11|Reported Event|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13047|NCT02286518|E10|Reported Event|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
13048|NCT02286518|E9|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13049|NCT02286518|E8|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
13050|NCT02286518|E7|Reported Event|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13051|NCT02286518|E6|Reported Event|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13052|NCT02286518|E5|Reported Event|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
13053|NCT02286518|E4|Reported Event|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13054|NCT02286518|E3|Reported Event|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13055|NCT02286518|E2|Reported Event|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13056|NCT02286518|E1|Reported Event|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
13057|NCT02286193|B1|Baseline|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
13058|NCT02286193|P1|Participant Flow|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
13059|NCT02286193|O1|Outcome|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
13060|NCT02286193|O1|Outcome|Patients Presenting to Community Liaison|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
13061|NCT02286193|E1|Reported Event|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
13062|NCT02285998|B3|Baseline|Total|Total of all reporting groups
13063|NCT02285998|B2|Baseline|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13064|NCT02285998|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13065|NCT02285998|P2|Participant Flow|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13066|NCT02285998|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13067|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13068|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13069|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13070|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13071|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13072|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13073|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13074|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13075|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13076|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13077|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13078|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13079|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13080|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13081|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13082|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13083|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13084|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13085|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13086|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13107|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
13087|NCT02285998|E2|Reported Event|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
13088|NCT02285998|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
13089|NCT02285270|B1|Baseline|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13090|NCT02285270|P1|Participant Flow|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13091|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13092|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13093|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13094|NCT02285270|E1|Reported Event|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
13095|NCT02284880|B3|Baseline|Total|Total of all reporting groups
13096|NCT02284880|B2|Baseline|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
13097|NCT02284880|B1|Baseline|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
13098|NCT02284880|P4|Participant Flow|800 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
13099|NCT02284880|P3|Participant Flow|800 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
13100|NCT02284880|P2|Participant Flow|400 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
13101|NCT02284880|P1|Participant Flow|400 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
13102|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
13103|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
13104|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
13105|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
13106|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
13109|NCT02284880|E5|Reported Event|800 mg Tablet of ESL (TBM)|800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
13110|NCT02284880|E4|Reported Event|800 mg Tablet of ESL (MF)|800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
13111|NCT02284880|E3|Reported Event|400 mg Tablet of ESL (TBM)|400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
13112|NCT02284880|E2|Reported Event|400 mg Tablet of ESL (MF)|400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
13113|NCT02284880|E1|Reported Event|Before Treatment|Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
13114|NCT02284867|B3|Baseline|Total|Total of all reporting groups
13115|NCT02284867|B2|Baseline|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13116|NCT02284867|B1|Baseline|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13117|NCT02284867|P2|Participant Flow|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13118|NCT02284867|P1|Participant Flow|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13119|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13120|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13121|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13154|NCT02284828|E3|Reported Event|BIA 2-093 800 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
13155|NCT02284828|E2|Reported Event|Placebo|Placebo, PLC
13156|NCT02284828|E1|Reported Event|BIA 2-093 900 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
13157|NCT02284555|B1|Baseline|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
13122|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13123|NCT02284867|E2|Reported Event|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13124|NCT02284867|E1|Reported Event|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
13125|NCT02284854|B3|Baseline|Total|Total of all reporting groups
13126|NCT02284854|B2|Baseline|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
13127|NCT02284854|B1|Baseline|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13128|NCT02284854|P2|Participant Flow|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13129|NCT02284854|P1|Participant Flow|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13130|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13131|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13132|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13133|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13134|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13135|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
13136|NCT02284854|E9|Reported Event|After Treatment|Group A and B After treatment
13137|NCT02284854|E8|Reported Event|Before Treatment|Group A and B Before treatment
13138|NCT02284854|E7|Reported Event|ESL 800 mg + CBZ 400 mg|Group A ESL 800 mg + CBZ 400 mg
13139|NCT02284854|E6|Reported Event|ESL 800 mg + CBZ 200 mg|Group A ESL 800 mg + CBZ 200 mg
13140|NCT02284854|E5|Reported Event|ESL 800 mg|Group A ESL 800 mg
13141|NCT02284854|E4|Reported Event|ESL 800 mg + CBZ 400 mg Twice-daily|Group A + B ESL 800 mg + CBZ 400 mg twice-daily
13142|NCT02284854|E3|Reported Event|CBZ 400 mg Twice-daily|Group B CBZ 400 mg twice-daily
13143|NCT02284854|E2|Reported Event|CBZ 400 mg|Group B CBZ 400 mg
13144|NCT02284854|E1|Reported Event|CBZ 200 mg|Group B CBZ 200 mg
13145|NCT02284828|B1|Baseline|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13146|NCT02284828|P1|Participant Flow|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13147|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13148|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13149|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13150|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13151|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13152|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
13153|NCT02284828|E4|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
13158|NCT02284555|P1|Participant Flow|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
13159|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
13160|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
13161|NCT02284555|E1|Reported Event|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
13162|NCT02284386|B1|Baseline|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13163|NCT02284386|P1|Participant Flow|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13164|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13165|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13166|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13167|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13168|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13169|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13170|NCT02284386|E1|Reported Event|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
13171|NCT02284347|B1|Baseline|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13172|NCT02284347|P1|Participant Flow|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13173|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13174|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13175|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13214|NCT02283840|E6|Reported Event|Reference 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
13215|NCT02283840|E5|Reported Event|Reference 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
13176|NCT02284347|E1|Reported Event|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
13177|NCT02284165|B4|Baseline|Total|Total of all reporting groups
13178|NCT02284165|B3|Baseline|Discharged Home|Discharged from hospital to home with or without services
13179|NCT02284165|B2|Baseline|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13180|NCT02284165|B1|Baseline|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13181|NCT02284165|P3|Participant Flow|Discharged Home|Discharged from hospital to home with or without services
13182|NCT02284165|P2|Participant Flow|Skilled Nursing Facility (SNF)|Discharged from hospital to skilled nursing facility
13183|NCT02284165|P1|Participant Flow|Inpatient Rehab Facility (IRF)|Discharged from hospital to inpatient rehabilitation facility
13184|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13185|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13186|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13187|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13188|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13189|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13190|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13191|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13192|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13193|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13194|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
13195|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
13196|NCT02284165|O1|Outcome|All Patients|Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
13197|NCT02284165|E1|Reported Event|All Patients|Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry.
13198|NCT02283840|B4|Baseline|Total|Total of all reporting groups
13199|NCT02283840|B3|Baseline|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13200|NCT02283840|B2|Baseline|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13201|NCT02283840|B1|Baseline|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13202|NCT02283840|P3|Participant Flow|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13203|NCT02283840|P2|Participant Flow|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13204|NCT02283840|P1|Participant Flow|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13205|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13206|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13207|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13208|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13209|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13210|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13211|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13212|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
13213|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
14984|NCT02248818|P5|Participant Flow|AZD8108 50 mg|AZD8108 50 mg MAD, Cohort 5
13217|NCT02283840|E3|Reported Event|Test 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg To-Be-Marketed Formulation, TBM
13218|NCT02283840|E2|Reported Event|Test 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg To-Be-Marketed Formulation, TBM
13219|NCT02283840|E1|Reported Event|Test 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg To-Be-Marketed Formulation, TBM
13220|NCT02283827|B3|Baseline|Total|Total of all reporting groups
13221|NCT02283827|B2|Baseline|Group B BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
13222|NCT02283827|B1|Baseline|Group A BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
13223|NCT02283827|P2|Participant Flow|Group B BIA 2-093 + Phenytoin (PHT)|"Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg~+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg"
13224|NCT02283827|P1|Participant Flow|Group A BIA 2-093 + Phenytoin (PHT)|Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
13225|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
13226|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
13227|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
13228|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
13229|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
13230|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin|Phenytoin - PHT; BIA 2-093 - ESL, Eslicarbazepine
13231|NCT02283827|E7|Reported Event|BIA 2-093 600 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
13232|NCT02283827|E6|Reported Event|Phenytoin 300 mg|Phenytoin - PHT 300 mg
13233|NCT02283827|E5|Reported Event|Phenytoin 100 mg|Phenytoin - PHT 100 mg
13234|NCT02283827|E4|Reported Event|BIA 2-093 1200 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
13235|NCT02283827|E3|Reported Event|BIA 2-093 1200 mg + Phenytoin 100 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
13236|NCT02283827|E2|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine
13237|NCT02283827|E1|Reported Event|BIA 2-093 600 mg|BIA 2-093 - ESL, Eslicarbazepine
13238|NCT02283814|B3|Baseline|Total|Total of all reporting groups
13239|NCT02283814|B2|Baseline|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
13240|NCT02283814|B1|Baseline|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
13241|NCT02283814|P2|Participant Flow|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
13242|NCT02283814|P1|Participant Flow|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
13243|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
13244|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
13245|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
13246|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
13247|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
13248|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
13249|NCT02283814|E2|Reported Event|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
13250|NCT02283814|E1|Reported Event|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
13251|NCT02283788|B5|Baseline|Total|Total of all reporting groups
13252|NCT02283788|B4|Baseline|Treatment Sequence DCBA|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
13253|NCT02283788|B3|Baseline|Treatment Sequence CADB|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
13254|NCT02283788|B2|Baseline|Treatment Sequence BDAC|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
13255|NCT02283788|B1|Baseline|Treatment Sequence ABCD|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
13256|NCT02283788|P4|Participant Flow|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
13257|NCT02283788|P3|Participant Flow|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
13258|NCT02283788|P2|Participant Flow|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
13259|NCT02283788|P1|Participant Flow|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
13260|NCT02283788|O4|Outcome|Placebo|Placebo, PLC
13261|NCT02283788|O3|Outcome|Moxifloxacin 400 mg|brand names Avelox, Avalox, and Avelon
13262|NCT02283788|O2|Outcome|BIA 2-093 2400 mg|ESL, Eslicarbazepine 1200 mg
13263|NCT02283788|O1|Outcome|BIA 2-093 1200 mg|ESL, Eslicarbazepine 1200 mg
13264|NCT02283788|E4|Reported Event|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
13265|NCT02283788|E3|Reported Event|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
13266|NCT02283788|E2|Reported Event|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
13267|NCT02283788|E1|Reported Event|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
13268|NCT02282982|B1|Baseline|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13269|NCT02282982|P1|Participant Flow|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13270|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13271|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13272|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13273|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13274|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13275|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13276|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13277|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13278|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13279|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13280|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13281|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13282|NCT02282982|E1|Reported Event|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
13283|NCT02282813|B4|Baseline|Total|Total of all reporting groups
13284|NCT02282813|B3|Baseline|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13285|NCT02282813|B2|Baseline|CTAP101 Capsules (Monotherapy; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13286|NCT02282813|B1|Baseline|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13287|NCT02282813|P3|Participant Flow|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13288|NCT02282813|P2|Participant Flow|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13336|NCT02281591|P3|Participant Flow|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
17840|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
13289|NCT02282813|P1|Participant Flow|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13290|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13291|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13292|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13293|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13294|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13295|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13296|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13297|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13298|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13299|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13300|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13301|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13302|NCT02282813|E3|Reported Event|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
13303|NCT02282813|E2|Reported Event|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
13304|NCT02282813|E1|Reported Event|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
13305|NCT02282605|B4|Baseline|Total|Total of all reporting groups
13306|NCT02282605|B3|Baseline|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13307|NCT02282605|B2|Baseline|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13308|NCT02282605|B1|Baseline|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13309|NCT02282605|P3|Participant Flow|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13310|NCT02282605|P2|Participant Flow|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13311|NCT02282605|P1|Participant Flow|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13312|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13313|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13314|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13315|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13316|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13317|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13318|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13319|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13320|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13321|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13322|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13323|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13324|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13325|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13326|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13327|NCT02282605|E3|Reported Event|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
13328|NCT02282605|E2|Reported Event|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13329|NCT02282605|E1|Reported Event|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
13330|NCT02281591|B5|Baseline|Total|Total of all reporting groups
13331|NCT02281591|B4|Baseline|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13332|NCT02281591|B3|Baseline|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13333|NCT02281591|B2|Baseline|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13334|NCT02281591|B1|Baseline|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13335|NCT02281591|P4|Participant Flow|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13337|NCT02281591|P2|Participant Flow|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13338|NCT02281591|P1|Participant Flow|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13339|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13340|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13341|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13342|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13343|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13344|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13345|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13346|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13347|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13348|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13349|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13350|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13351|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13352|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13353|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13354|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13355|NCT02281591|E4|Reported Event|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
13356|NCT02281591|E3|Reported Event|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
13357|NCT02281591|E2|Reported Event|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
13358|NCT02281591|E1|Reported Event|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
13359|NCT02281526|B3|Baseline|Total|Total of all reporting groups
13360|NCT02281526|B2|Baseline|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13361|NCT02281526|B1|Baseline|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13362|NCT02281526|P2|Participant Flow|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13363|NCT02281526|P1|Participant Flow|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13364|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13365|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13366|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13367|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13368|NCT02281526|E2|Reported Event|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13369|NCT02281526|E1|Reported Event|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
13370|NCT02281448|B3|Baseline|Total|Total of all reporting groups
13371|NCT02281448|B2|Baseline|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
13372|NCT02281448|B1|Baseline|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
13373|NCT02281448|P2|Participant Flow|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
13374|NCT02281448|P1|Participant Flow|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
13375|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
13376|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
13377|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
13378|NCT02281448|O1|Outcome|Cmax (BIA 2-194)|Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
13379|NCT02281448|E2|Reported Event|Microginon®|Microginon® (n=18)
13380|NCT02281448|E1|Reported Event|Eslicarbazepine Acetate 1200 mg + Microginon®|Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
13381|NCT02281422|B6|Baseline|Total|Total of all reporting groups
13382|NCT02281422|B5|Baseline|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13383|NCT02281422|B4|Baseline|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13384|NCT02281422|B3|Baseline|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13385|NCT02281422|B2|Baseline|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13386|NCT02281422|B1|Baseline|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13387|NCT02281422|P5|Participant Flow|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13388|NCT02281422|P4|Participant Flow|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13389|NCT02281422|P3|Participant Flow|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13390|NCT02281422|P2|Participant Flow|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13391|NCT02281422|P1|Participant Flow|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13392|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13393|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13394|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13395|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13396|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13397|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13398|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13399|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13400|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13401|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13402|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13403|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13404|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13405|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13406|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13407|NCT02281422|E5|Reported Event|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
13408|NCT02281422|E4|Reported Event|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
13409|NCT02281422|E3|Reported Event|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
13410|NCT02281422|E2|Reported Event|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
13411|NCT02281422|E1|Reported Event|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
13412|NCT02281136|B1|Baseline|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13413|NCT02281136|P1|Participant Flow|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13414|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13415|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13416|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13417|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13571|NCT02277626|B1|Baseline|Total Number of Participants|
14985|NCT02248818|P4|Participant Flow|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
13418|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13419|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13420|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13421|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13422|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13423|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13424|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13425|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13426|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13427|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13428|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13429|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13430|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13431|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13432|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13433|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13434|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13435|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13436|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13860|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
13437|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13438|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13439|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13440|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13441|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13442|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13443|NCT02281136|E1|Reported Event|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
13444|NCT02280655|B3|Baseline|Total|Total of all reporting groups
13445|NCT02280655|B2|Baseline|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
13446|NCT02280655|B1|Baseline|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
13447|NCT02280655|P2|Participant Flow|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
13448|NCT02280655|P1|Participant Flow|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
13449|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
13450|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
13451|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
13452|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
13453|NCT02280655|E2|Reported Event|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
13454|NCT02280655|E1|Reported Event|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
13455|NCT02280499|B1|Baseline|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13456|NCT02280499|P1|Participant Flow|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13457|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13767|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13458|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13459|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13460|NCT02280499|E1|Reported Event|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
13461|NCT02280187|B1|Baseline|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13462|NCT02280187|P1|Participant Flow|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13463|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13464|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13465|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13466|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13467|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13468|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13469|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13470|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13471|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13472|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13473|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13474|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13475|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13476|NCT02280187|E1|Reported Event|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
13477|NCT02280122|B3|Baseline|Total|Total of all reporting groups
13478|NCT02280122|B2|Baseline|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13479|NCT02280122|B1|Baseline|Generalised Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13480|NCT02280122|P3|Participant Flow|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13481|NCT02280122|P2|Participant Flow|Severe Chronic Periodontitis|"Sites with probing PPD ≥ 3.5 mm~PAL-V ≥ 5 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13482|NCT02280122|P1|Participant Flow|Moderate Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13861|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13483|NCT02280122|O2|Outcome|Specificity: Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13484|NCT02280122|O1|Outcome|Sensitivity: Generalised Moderate/Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13485|NCT02280122|E2|Reported Event|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13486|NCT02280122|E1|Reported Event|Generalized Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
13487|NCT02279667|B4|Baseline|Total|Total of all reporting groups
13488|NCT02279667|B3|Baseline|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
13489|NCT02279667|B2|Baseline|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
13490|NCT02279667|B1|Baseline|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
13491|NCT02279667|P3|Participant Flow|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
13492|NCT02279667|P2|Participant Flow|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
13493|NCT02279667|P1|Participant Flow|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
13494|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
13495|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
13496|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
13497|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
13498|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
13499|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
13500|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
13501|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
13502|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
13503|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
13504|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
13505|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
13506|NCT02279667|E4|Reported Event|Follow-up|Follow-up.
13507|NCT02279667|E3|Reported Event|BIA 2-093 One 800 mg Tablet|BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
13508|NCT02279667|E2|Reported Event|BIA 2-093 - Four 200 mg Tablets|BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
13509|NCT02279667|E1|Reported Event|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
13510|NCT02279407|B5|Baseline|Total|Total of all reporting groups
13511|NCT02279407|B4|Baseline|Placebo|Placebo to Epanova and placebo to Dapagliflozin
13512|NCT02279407|B3|Baseline|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
13513|NCT02279407|B2|Baseline|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
13514|NCT02279407|B1|Baseline|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
13515|NCT02279407|P4|Participant Flow|Placebo|Placebo to Epanova and placebo to Dapagliflozin
13516|NCT02279407|P3|Participant Flow|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
13517|NCT02279407|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
13518|NCT02279407|P1|Participant Flow|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
13519|NCT02279407|O3|Outcome|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
13520|NCT02279407|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
13521|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
13522|NCT02279407|O2|Outcome|Placebo|Placebo to Epanova and placebo to Dapagliflozin
13523|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
13524|NCT02279407|E4|Reported Event|Placebo|Placebo to Epanova and placebo to Dapagliflozin
13525|NCT02279407|E3|Reported Event|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
13526|NCT02279407|E2|Reported Event|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
13527|NCT02279407|E1|Reported Event|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
13528|NCT02278783|B1|Baseline|All Patients|
13529|NCT02278783|P1|Participant Flow|All Patients|
13530|NCT02278783|O1|Outcome|All Patients|
13531|NCT02278783|O1|Outcome|All Patients|
13532|NCT02278783|O1|Outcome|All Patients|
13533|NCT02278783|O1|Outcome|All Patients|
13534|NCT02278783|E1|Reported Event|All Patients|
13535|NCT02278640|B1|Baseline|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
14986|NCT02248818|P3|Participant Flow|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
13536|NCT02278640|P1|Participant Flow|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13537|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13538|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13539|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13540|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13541|NCT02278640|E1|Reported Event|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
13542|NCT02278614|B3|Baseline|Total|Total of all reporting groups
13543|NCT02278614|B2|Baseline|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
13544|NCT02278614|B1|Baseline|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
13545|NCT02278614|P2|Participant Flow|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
13546|NCT02278614|P1|Participant Flow|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
13547|NCT02278614|O2|Outcome|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
13548|NCT02278614|O1|Outcome|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
13549|NCT02278614|E2|Reported Event|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
13550|NCT02278614|E1|Reported Event|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
13551|NCT02278484|B1|Baseline|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13552|NCT02278484|P1|Participant Flow|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13553|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13554|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13555|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13556|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation Using XprESS and PathAssist Devices.
13557|NCT02278484|E1|Reported Event|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
13558|NCT02278146|B3|Baseline|Total|Total of all reporting groups
13559|NCT02278146|B2|Baseline|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13560|NCT02278146|B1|Baseline|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13561|NCT02278146|P2|Participant Flow|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13562|NCT02278146|P1|Participant Flow|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13563|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13564|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13565|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13566|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13567|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13568|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13569|NCT02278146|E2|Reported Event|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13570|NCT02278146|E1|Reported Event|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
13572|NCT02277626|P2|Participant Flow|ElectroFlo First Then Vest|"Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest.~Electro Flo 5000: Airway clearance device"
13573|NCT02277626|P1|Participant Flow|Vest First Then ElectroFlo|"Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000.~EnCourage Vest System: Airway Clearance Device"
13574|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
13575|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
13576|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
13577|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
13578|NCT02277626|O2|Outcome|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
13579|NCT02277626|O1|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
13580|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
13581|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~Incourage Vest System: Airway Clearance Device"
13582|NCT02277626|O2|Outcome|Elecflo Arm|"Elecflo Arm~Electro Flo 5000: Airway clearance device"
13583|NCT02277626|O1|Outcome|Vest|"VEST Arm~Incourage Vest System: Airway Clearance Device"
13584|NCT02277626|E2|Reported Event|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
13585|NCT02277626|E1|Reported Event|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
13586|NCT02277249|B3|Baseline|Total|Total of all reporting groups
13587|NCT02277249|B2|Baseline|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13588|NCT02277249|B1|Baseline|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13589|NCT02277249|P2|Participant Flow|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13590|NCT02277249|P1|Participant Flow|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13591|NCT02277249|O2|Outcome|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13592|NCT02277249|O1|Outcome|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13593|NCT02277249|E2|Reported Event|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13594|NCT02277249|E1|Reported Event|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
13595|NCT02277119|B4|Baseline|Total|Total of all reporting groups
13596|NCT02277119|B3|Baseline|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13597|NCT02277119|B2|Baseline|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13598|NCT02277119|B1|Baseline|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13599|NCT02277119|P3|Participant Flow|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13600|NCT02277119|P2|Participant Flow|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13601|NCT02277119|P1|Participant Flow|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13862|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
13602|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13603|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13604|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13605|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13606|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13607|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13608|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13609|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13610|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13611|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13612|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13613|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13614|NCT02277119|E3|Reported Event|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13615|NCT02277119|E2|Reported Event|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13616|NCT02277119|E1|Reported Event|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
13617|NCT02276274|B3|Baseline|Total|Total of all reporting groups
13618|NCT02276274|B2|Baseline|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
13619|NCT02276274|B1|Baseline|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
13620|NCT02276274|P2|Participant Flow|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
13621|NCT02276274|P1|Participant Flow|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
13622|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13623|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13624|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13625|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13626|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13627|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13628|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13629|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13863|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13630|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13631|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13632|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13633|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13634|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13635|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13636|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13637|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13638|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13639|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13640|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13641|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13642|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13643|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13644|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13645|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13646|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13647|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13648|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13649|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13650|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13651|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13652|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13653|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13654|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13655|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13656|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13657|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13658|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13659|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13660|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13661|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13662|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13663|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13664|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13864|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
13665|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13666|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13667|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13668|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13669|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13670|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13671|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13672|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13673|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13674|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13675|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13676|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13677|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13678|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13679|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13680|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13681|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13682|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13683|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13684|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13685|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13686|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13687|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13688|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13689|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13690|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13691|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13692|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13693|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13694|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13695|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13696|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13697|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13698|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13699|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13865|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13700|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13701|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13702|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13703|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13704|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13705|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13706|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13707|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13708|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13709|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13710|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13711|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13712|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13713|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13714|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13715|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13716|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13717|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13718|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13719|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13720|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13721|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13722|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13723|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13724|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13725|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13726|NCT02276274|E2|Reported Event|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
13727|NCT02276274|E1|Reported Event|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
13728|NCT02275767|B4|Baseline|Total|Total of all reporting groups
13729|NCT02275767|B3|Baseline|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
13730|NCT02275767|B2|Baseline|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
13731|NCT02275767|B1|Baseline|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
13732|NCT02275767|P3|Participant Flow|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
13733|NCT02275767|P2|Participant Flow|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
13734|NCT02275767|P1|Participant Flow|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
13735|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
13736|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
13737|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
13738|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
13739|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
13740|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
13741|NCT02275767|E3|Reported Event|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
13742|NCT02275767|E2|Reported Event|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
13743|NCT02275767|E1|Reported Event|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
13744|NCT02275546|B1|Baseline|All Randomized Participants|
13745|NCT02275546|P2|Participant Flow|No Applicator (Manual)→Applicator|In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
13746|NCT02275546|P1|Participant Flow|Applicator→No Applicator (Manual)|In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.
13747|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
13748|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
13749|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
13750|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
13751|NCT02275546|E2|Reported Event|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
13752|NCT02275546|E1|Reported Event|Applicator|Participants used the applicator to insert the vaginal ring.
13753|NCT02275364|B1|Baseline|Overall|Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant.
13754|NCT02275364|P2|Participant Flow|Sequence 2|In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
13755|NCT02275364|P1|Participant Flow|Sequence 1|In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
13756|NCT02275364|O1|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
13757|NCT02275364|O2|Outcome|Placebo Strip|Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
13758|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13759|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13760|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13761|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13762|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13763|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
13764|NCT02275364|O3|Outcome|Decongestant|A marketed nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
13765|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13766|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13768|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13769|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
13770|NCT02275364|O3|Outcome|Decongestant|A nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
13771|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13772|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13773|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13774|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13775|NCT02275364|O4|Outcome|Test Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
13776|NCT02275364|O3|Outcome|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
13777|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13778|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
13779|NCT02275364|E4|Reported Event|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
13780|NCT02275364|E3|Reported Event|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
13781|NCT02275364|E2|Reported Event|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
13782|NCT02275364|E1|Reported Event|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
13783|NCT02275156|B4|Baseline|Total|Total of all reporting groups
13784|NCT02275156|B3|Baseline|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13785|NCT02275156|B2|Baseline|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13786|NCT02275156|B1|Baseline|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13787|NCT02275156|P3|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13788|NCT02275156|P2|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13789|NCT02275156|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13790|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13791|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13792|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13793|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13794|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13795|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13796|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13797|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13798|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13799|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13800|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13801|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13802|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13832|NCT02274792|B1|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13803|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13804|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13805|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13806|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13807|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13808|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13809|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13810|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13811|NCT02275156|E4|Reported Event|Evolocumab 140 mg - Total|Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13812|NCT02275156|E3|Reported Event|Evolocumab 140 mg - ESRD Requiring Hemodialysis|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13813|NCT02275156|E2|Reported Event|Evolocumab 140 mg - Severe RI|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13814|NCT02275156|E1|Reported Event|Evolocumab 140 mg - Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
13815|NCT02274948|B3|Baseline|Total|Total of all reporting groups
13816|NCT02274948|B2|Baseline|Placebo|"173 were randomized to receive placebo~Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one"
13817|NCT02274948|B1|Baseline|Metformin|"166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).~Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia"
13818|NCT02274948|P2|Participant Flow|Placebo|"A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
13819|NCT02274948|P1|Participant Flow|Metformin|"8-10.99 year old children will receive metformin. Initially children will be given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
13820|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
13821|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
13822|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
13823|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
13824|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
13825|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
13826|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
13827|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)
13828|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
13829|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
13830|NCT02274948|E2|Reported Event|Placebo|"The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
13831|NCT02274948|E1|Reported Event|Metformin|"8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
13833|NCT02274792|P1|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13834|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13835|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13836|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13837|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13838|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13839|NCT02274792|E1|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
13840|NCT02274675|B1|Baseline|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13841|NCT02274675|P1|Participant Flow|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13842|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13843|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13844|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13845|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13846|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13847|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13848|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13849|NCT02274675|E1|Reported Event|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
13850|NCT02273908|B3|Baseline|Total|Total of all reporting groups
13851|NCT02273908|B2|Baseline|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
13852|NCT02273908|B1|Baseline|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
13853|NCT02273908|P2|Participant Flow|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
13854|NCT02273908|P1|Participant Flow|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13855|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care : No intervention
13856|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care : no intervention
13857|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13858|NCT02273908|O2|Outcome|Other Analgesics|2.Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
13859|NCT02273908|O1|Outcome|Pregabalin|1.Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13866|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
13867|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13868|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
13869|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13870|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
13871|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13872|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
13873|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
13874|NCT02273908|E1|Reported Event|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
13875|NCT02273752|B1|Baseline|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13876|NCT02273752|P1|Participant Flow|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13877|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13878|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13879|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13880|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13881|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13882|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13914|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13915|NCT02273310|E2|Reported Event|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
14113|NCT02266381|E3|Reported Event|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
13883|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13884|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13885|NCT02273752|E1|Reported Event|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
13886|NCT02273323|B1|Baseline|All Study Participants|Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
13887|NCT02273323|P2|Participant Flow|Placebo Then Tea|Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
13888|NCT02273323|P1|Participant Flow|Tea Then Placebo|Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
13889|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13890|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13891|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13892|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13893|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13894|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13895|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13896|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13897|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13898|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13899|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13900|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13901|NCT02273323|E2|Reported Event|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
13902|NCT02273323|E1|Reported Event|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
13903|NCT02273310|B3|Baseline|Total|Total of all reporting groups
13904|NCT02273310|B2|Baseline|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
13905|NCT02273310|B1|Baseline|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13906|NCT02273310|P2|Participant Flow|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
13907|NCT02273310|P1|Participant Flow|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13908|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day Problem-Solving Skills training for disease management intervention~Problem-Solving Skills Training for Disease Management: Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease."
13909|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
13910|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13911|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
13912|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13913|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
14987|NCT02248818|P2|Participant Flow|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
13916|NCT02273310|E1|Reported Event|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
13917|NCT02271854|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13918|NCT02271854|P1|Participant Flow|Diclofenac Sodium Gel 1% and Placebo Gel|This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
13919|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13920|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13921|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13922|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13923|NCT02271854|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
13924|NCT02271529|B1|Baseline|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
13925|NCT02271529|P1|Participant Flow|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
13926|NCT02271529|O1|Outcome|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
13927|NCT02271529|E1|Reported Event|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
13928|NCT02271477|B3|Baseline|Total|Total of all reporting groups
13929|NCT02271477|B2|Baseline|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
13930|NCT02271477|B1|Baseline|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13931|NCT02271477|P2|Participant Flow|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36%"
13932|NCT02271477|P1|Participant Flow|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13933|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
13934|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13947|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
14536|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
13935|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
13936|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13937|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
13938|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13939|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
13940|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13941|NCT02271477|E2|Reported Event|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
13942|NCT02271477|E1|Reported Event|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
13943|NCT02269657|B1|Baseline|Subject Cohort|Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
13944|NCT02269657|P1|Participant Flow|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
13945|NCT02269657|O3|Outcome|Natural Standing Position|Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
13946|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
14537|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
13948|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13949|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13950|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13951|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13952|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13953|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13954|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13955|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
13956|NCT02269657|E1|Reported Event|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
13957|NCT02269488|B1|Baseline|MEDI3250|MEDI3250 was administered to all subjects.
13958|NCT02269488|P1|Participant Flow|MEDI3250|MEDI3250 was administered to all subjects.
13959|NCT02269488|O1|Outcome|MEDI3250|MEDI3250 was administered to all subjects.
13960|NCT02269488|E1|Reported Event|MEDI3250|MEDI3250 was administered to all subjects.
13961|NCT02269475|B3|Baseline|Total|Total of all reporting groups
13962|NCT02269475|B2|Baseline|Placebo|Placebo, 0.2mL as nasal spray
13963|NCT02269475|B1|Baseline|MEDI3250|MEDI3250, 0.2mL as nasal spray
13964|NCT02269475|P2|Participant Flow|Placebo|Placebo, 0.2mL as nasal spray
13965|NCT02269475|P1|Participant Flow|MEDI3250|MEDI3250, 0.2mL as nasal spray
13966|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
13967|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
13968|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
13969|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
13970|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
13971|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
13972|NCT02269475|E3|Reported Event|Total Number|
13973|NCT02269475|E2|Reported Event|Placebo|Placebo, 0.2mL as nasal spray
13974|NCT02269475|E1|Reported Event|MEDI3250|MEDI3250, 0.2mL as nasal spray
13975|NCT02269098|B3|Baseline|Total|Total of all reporting groups
13976|NCT02269098|B2|Baseline|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13977|NCT02269098|B1|Baseline|Intervention|"Diabetes survival skills self-management education (G meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13978|NCT02269098|P2|Participant Flow|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
17841|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
13979|NCT02269098|P1|Participant Flow|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13980|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13981|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation.~Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Navigation included securing a primary care"
13982|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13983|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13984|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13985|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13986|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13987|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13988|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
14011|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
13989|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13990|NCT02269098|E2|Reported Event|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
13991|NCT02269098|E1|Reported Event|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
13992|NCT02268864|B4|Baseline|Total|Total of all reporting groups
13993|NCT02268864|B3|Baseline|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
13994|NCT02268864|B2|Baseline|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
13995|NCT02268864|B1|Baseline|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
13996|NCT02268864|P3|Participant Flow|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
13997|NCT02268864|P2|Participant Flow|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
13998|NCT02268864|P1|Participant Flow|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
13999|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
14000|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
14001|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
14002|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
14003|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
14004|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
14005|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
14006|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
14007|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
14008|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
14009|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
14010|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
14112|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14012|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
14013|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
14014|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
14015|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
14016|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
14017|NCT02268864|E2|Reported Event|12-24 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has AEs that started after day 88 on treatment.
14018|NCT02268864|E1|Reported Event|1-12 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has adverse events (AEs) that started before or on day 88 on treatment.
14019|NCT02268396|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14020|NCT02268396|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14021|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14022|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14023|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14024|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14025|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14026|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14027|NCT02268396|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
14028|NCT02268058|B5|Baseline|Total|Total of all reporting groups
14029|NCT02268058|B4|Baseline|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14030|NCT02268058|B3|Baseline|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14031|NCT02268058|B2|Baseline|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14032|NCT02268058|B1|Baseline|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14033|NCT02268058|P4|Participant Flow|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14034|NCT02268058|P3|Participant Flow|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14035|NCT02268058|P2|Participant Flow|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14036|NCT02268058|P1|Participant Flow|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14037|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14038|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14039|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14040|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
17842|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
14041|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14042|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14043|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14044|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14045|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14046|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14047|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14048|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14049|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14050|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14051|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14052|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14053|NCT02268058|E4|Reported Event|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
14054|NCT02268058|E3|Reported Event|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
14055|NCT02268058|E2|Reported Event|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
14056|NCT02268058|E1|Reported Event|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
14057|NCT02267837|B3|Baseline|Total|Total of all reporting groups
14058|NCT02267837|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
14059|NCT02267837|B1|Baseline|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
14060|NCT02267837|P2|Participant Flow|No OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
14061|NCT02267837|P1|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
14062|NCT02267837|O2|Outcome|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
14063|NCT02267837|O1|Outcome|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
14064|NCT02267837|E2|Reported Event|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
14065|NCT02267837|E1|Reported Event|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
14066|NCT02267824|B3|Baseline|Total|Total of all reporting groups
14067|NCT02267824|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
14068|NCT02267824|B1|Baseline|Extra-Oral OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home."
14069|NCT02267824|P2|Participant Flow|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
14070|NCT02267824|P1|Participant Flow|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
14071|NCT02267824|O2|Outcome|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
14072|NCT02267824|O1|Outcome|Extraoral OrthoPulse® PBM and Orthodontic Treatment|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
14073|NCT02267824|E2|Reported Event|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
14074|NCT02267824|E1|Reported Event|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
14075|NCT02266797|B3|Baseline|Total|Total of all reporting groups
14076|NCT02266797|B2|Baseline|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14077|NCT02266797|B1|Baseline|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14078|NCT02266797|P2|Participant Flow|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14079|NCT02266797|P1|Participant Flow|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14080|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14081|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14082|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
17843|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
14083|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14084|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14085|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14086|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14087|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14088|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14089|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14090|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14091|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14092|NCT02266797|E2|Reported Event|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
14093|NCT02266797|E1|Reported Event|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
14094|NCT02266381|B4|Baseline|Total|Total of all reporting groups
14095|NCT02266381|B3|Baseline|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14096|NCT02266381|B2|Baseline|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14097|NCT02266381|B1|Baseline|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14098|NCT02266381|P3|Participant Flow|Combined-guided Group|Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14099|NCT02266381|P2|Participant Flow|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14100|NCT02266381|P1|Participant Flow|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14101|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14102|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14103|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14104|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14105|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14106|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14107|NCT02266381|O3|Outcome|Combined Group|Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14108|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14109|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided undergo MPCNL using only US-guided renal access.
14110|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
14111|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14114|NCT02266381|E2|Reported Event|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
14115|NCT02266381|E1|Reported Event|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
14116|NCT02265848|B3|Baseline|Total|Total of all reporting groups
14117|NCT02265848|B2|Baseline|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14118|NCT02265848|B1|Baseline|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14119|NCT02265848|P2|Participant Flow|Treatment Group B|"Subjects randomized to the treatment group B will begin the 7 week study per sequence (e.g., Low frequency first, then High frequency and High frequency first, then Low frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
14120|NCT02265848|P1|Participant Flow|Treatment Group A|"Subjects randomized to the treatment group A will begin the 7 week study per sequence (e.g., High frequency first, then Low frequency and Low frequency first, then High frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
14121|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14122|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14123|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14124|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14125|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14126|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14127|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14156|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14480|NCT02258334|B4|Baseline|Group 4|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
14128|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14129|NCT02265848|E2|Reported Event|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14130|NCT02265848|E1|Reported Event|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
14131|NCT02264821|B4|Baseline|Total|Total of all reporting groups
14132|NCT02264821|B3|Baseline|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
14133|NCT02264821|B2|Baseline|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
14134|NCT02264821|B1|Baseline|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
14135|NCT02264821|P3|Participant Flow|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
14136|NCT02264821|P2|Participant Flow|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
14137|NCT02264821|P1|Participant Flow|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
14138|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
14139|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
14140|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
14141|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
14142|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
14143|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
14144|NCT02264821|E3|Reported Event|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
14145|NCT02264821|E2|Reported Event|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
14146|NCT02264821|E1|Reported Event|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
14147|NCT02264249|B4|Baseline|Total|Total of all reporting groups
14148|NCT02264249|B3|Baseline|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14149|NCT02264249|B2|Baseline|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14150|NCT02264249|B1|Baseline|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14151|NCT02264249|P3|Participant Flow|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14152|NCT02264249|P2|Participant Flow|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14153|NCT02264249|P1|Participant Flow|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14154|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14155|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14231|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14157|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14158|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14159|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14160|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14161|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14162|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14163|NCT02264249|E3|Reported Event|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14164|NCT02264249|E2|Reported Event|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14165|NCT02264249|E1|Reported Event|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
14166|NCT02263833|B1|Baseline|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
14167|NCT02263833|P1|Participant Flow|Overall Participants|Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
14168|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
14169|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
14170|NCT02263833|E1|Reported Event|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
14171|NCT02263131|B3|Baseline|Total|Total of all reporting groups
14172|NCT02263131|B2|Baseline|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
14173|NCT02263131|B1|Baseline|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
14174|NCT02263131|P2|Participant Flow|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
14175|NCT02263131|P1|Participant Flow|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
14176|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
14177|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
14178|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
14179|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
14180|NCT02263131|E2|Reported Event|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
14181|NCT02263131|E1|Reported Event|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
14182|NCT02263118|B5|Baseline|Total|Total of all reporting groups
14183|NCT02263118|B4|Baseline|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14184|NCT02263118|B3|Baseline|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14232|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14185|NCT02263118|B2|Baseline|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14186|NCT02263118|B1|Baseline|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14187|NCT02263118|P4|Participant Flow|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14188|NCT02263118|P3|Participant Flow|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14189|NCT02263118|P2|Participant Flow|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14190|NCT02263118|P1|Participant Flow|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14191|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14192|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14193|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14194|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14195|NCT02263118|O4|Outcome|Control Group|"There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14196|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14197|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14198|NCT02263118|O1|Outcome|Uni-directional SMS|"There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14199|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14200|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14201|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14202|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14203|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14233|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
17844|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
14204|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14205|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14206|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14207|NCT02263118|E4|Reported Event|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
14208|NCT02263118|E3|Reported Event|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
14209|NCT02263118|E2|Reported Event|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
14210|NCT02263118|E1|Reported Event|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
14211|NCT02262754|B4|Baseline|Total|Total of all reporting groups
14212|NCT02262754|B3|Baseline|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14213|NCT02262754|B2|Baseline|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14214|NCT02262754|B1|Baseline|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14215|NCT02262754|P3|Participant Flow|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14216|NCT02262754|P2|Participant Flow|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14217|NCT02262754|P1|Participant Flow|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14218|NCT02262754|O1|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14219|NCT02262754|O1|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14220|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14221|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14222|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14223|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14224|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14225|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14226|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14227|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14228|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14229|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14230|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14538|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14234|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14235|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14236|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14237|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14238|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14239|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14240|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14241|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14242|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14243|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14244|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14245|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14246|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14247|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14248|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14249|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14250|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14251|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14252|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14253|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14254|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14255|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14256|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14257|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14258|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14259|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14260|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14261|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14262|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14263|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14264|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14265|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14266|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14267|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14268|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14269|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14270|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14271|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14272|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14273|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14274|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14275|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14276|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14277|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14278|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14279|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14280|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14281|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14282|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14283|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14284|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14285|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14286|NCT02262754|E3|Reported Event|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
14287|NCT02262754|E2|Reported Event|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
14288|NCT02262754|E1|Reported Event|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
14289|NCT02262728|B3|Baseline|Total|Total of all reporting groups
14290|NCT02262728|B2|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14291|NCT02262728|B1|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14292|NCT02262728|P2|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14293|NCT02262728|P1|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14294|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14295|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14481|NCT02258334|B3|Baseline|Group 3|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14296|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14297|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14298|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14299|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14300|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14301|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14302|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14303|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14304|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14305|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14306|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14307|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14308|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14309|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14310|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14311|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14312|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14313|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14314|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14315|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14539|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14316|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14317|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14318|NCT02262728|E2|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14319|NCT02262728|E1|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
14320|NCT02262078|B3|Baseline|Total|Total of all reporting groups
14321|NCT02262078|B2|Baseline|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
14322|NCT02262078|B1|Baseline|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
14323|NCT02262078|P2|Participant Flow|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
14324|NCT02262078|P1|Participant Flow|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
14325|NCT02262078|O2|Outcome|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
14326|NCT02262078|O1|Outcome|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
14327|NCT02262078|E2|Reported Event|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
14328|NCT02262078|E1|Reported Event|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
14329|NCT02262039|B3|Baseline|Total|Total of all reporting groups
14330|NCT02262039|B2|Baseline|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14331|NCT02262039|B1|Baseline|Conventional Pressure|15mmHg target pressure
14332|NCT02262039|P2|Participant Flow|Low Pressure (VTI)|"10mmHg target pressure~VTI = Valveless recirculating insufflation"
14333|NCT02262039|P1|Participant Flow|Conventional Pressure|15mmHg target pressure
14334|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14335|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14336|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14337|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14338|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14339|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14340|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14341|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14342|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14343|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14344|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14345|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14346|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14347|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
14348|NCT02262039|E2|Reported Event|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
14349|NCT02262039|E1|Reported Event|Conventional Pressure|15mmHg target pressure
14350|NCT02261948|B3|Baseline|Total|Total of all reporting groups
14351|NCT02261948|B2|Baseline|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14388|NCT02260882|P1|Participant Flow|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14352|NCT02261948|B1|Baseline|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14353|NCT02261948|P2|Participant Flow|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14354|NCT02261948|P1|Participant Flow|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14355|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14356|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14357|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14358|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14359|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14389|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14390|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14360|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14361|NCT02261948|E2|Reported Event|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14362|NCT02261948|E1|Reported Event|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
14363|NCT02261428|B3|Baseline|Total|Total of all reporting groups
14364|NCT02261428|B2|Baseline|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
14365|NCT02261428|B1|Baseline|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
14366|NCT02261428|P2|Participant Flow|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
14367|NCT02261428|P1|Participant Flow|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
14368|NCT02261428|O2|Outcome|Suction Catheter|Presence of blood was found on Participants immediately after suctioning with Suction catheter
14369|NCT02261428|O1|Outcome|Catheter Tiemann|Presence of blood was found on Participants immediately after suctioning with catheter Tiemann
14370|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
14371|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
14372|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
14373|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
14374|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter
14375|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.
14376|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter
14377|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.
14378|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of time required to insert the trachea wth Suction catheter
14379|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of time required to insert the trachea wth catheter Tiemann.
14380|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of attempts made wth Suction catheter.
14381|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of attempts made wth catheter Tiemann.
14382|NCT02261428|E2|Reported Event|Suction Catheter|Participants received nasotracheal suction with Suction catheter
14383|NCT02261428|E1|Reported Event|Catheter Tiemann|Participants received nasotracheal suction with catheter Tiemann.
14384|NCT02260882|B3|Baseline|Total|Total of all reporting groups
14385|NCT02260882|B2|Baseline|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14386|NCT02260882|B1|Baseline|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14387|NCT02260882|P2|Participant Flow|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14482|NCT02258334|B2|Baseline|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14391|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14392|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14393|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14394|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14395|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14396|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14397|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14398|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14399|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14400|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14401|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14402|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14403|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14404|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14405|NCT02260882|O1|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14406|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14407|NCT02260882|E2|Reported Event|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
14408|NCT02260882|E1|Reported Event|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
14409|NCT02259608|B1|Baseline|yBCG|15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
14410|NCT02259608|P1|Participant Flow|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
14411|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
14412|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
14413|NCT02259608|E1|Reported Event|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
14414|NCT02259400|B3|Baseline|Total|Total of all reporting groups
14415|NCT02259400|B2|Baseline|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14461|NCT02258477|B1|Baseline|All Study Subjects|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week."
14988|NCT02248818|P1|Participant Flow|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
14416|NCT02259400|B1|Baseline|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14417|NCT02259400|P2|Participant Flow|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14418|NCT02259400|P1|Participant Flow|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14419|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14420|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14421|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14422|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14462|NCT02258477|P4|Participant Flow|Sequence 4 (B-C-D-A)|Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
14463|NCT02258477|P3|Participant Flow|Sequence 3 (C-A-B-D)|Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.
14464|NCT02258477|P2|Participant Flow|Sequence 2 (A-D-C-B)|Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.
14423|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14424|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14425|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14426|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14427|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14428|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14429|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14465|NCT02258477|P1|Participant Flow|Sequence 1 (D-B-A-C)|Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.
14483|NCT02258334|B1|Baseline|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14484|NCT02258334|P4|Participant Flow|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
14485|NCT02258334|P3|Participant Flow|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14430|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14431|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14432|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14433|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14434|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14435|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14436|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14466|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14437|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14438|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14439|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14440|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14441|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14442|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14443|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14467|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14989|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
14444|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14445|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14446|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14447|NCT02259400|E2|Reported Event|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
14448|NCT02259400|E1|Reported Event|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
14449|NCT02259348|B1|Baseline|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14450|NCT02259348|P1|Participant Flow|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14451|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14535|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14452|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14453|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14454|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14455|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14456|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14457|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14458|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14459|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14460|NCT02259348|E1|Reported Event|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
14990|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
14468|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
14469|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14470|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14471|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14472|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
14473|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14474|NCT02258477|O4|Outcome|10 Calorie|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14475|NCT02258477|O3|Outcome|50 Calorie Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14476|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
14477|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
14478|NCT02258477|E1|Reported Event|All Study Subjects|Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
14479|NCT02258334|B5|Baseline|Total|Total of all reporting groups
14486|NCT02258334|P2|Participant Flow|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14487|NCT02258334|P1|Participant Flow|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14488|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
14489|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14490|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14491|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14492|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
14493|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14494|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14495|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14496|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
14497|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14498|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
14499|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14500|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
14501|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14502|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14503|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14504|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
14505|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14506|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14507|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14508|NCT02258334|E4|Reported Event|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
14509|NCT02258334|E3|Reported Event|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14510|NCT02258334|E2|Reported Event|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
14511|NCT02258334|E1|Reported Event|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
14512|NCT02257918|B4|Baseline|Total|Total of all reporting groups
14513|NCT02257918|B3|Baseline|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14514|NCT02257918|B2|Baseline|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14515|NCT02257918|B1|Baseline|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14516|NCT02257918|P3|Participant Flow|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14517|NCT02257918|P2|Participant Flow|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14518|NCT02257918|P1|Participant Flow|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14519|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14520|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14521|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14522|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14523|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14524|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14525|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14526|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14527|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14528|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14529|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14530|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14531|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14532|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14533|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14534|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14991|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
14540|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14541|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14542|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14543|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14544|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14545|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14546|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14547|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14548|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14549|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14550|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14551|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14552|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14553|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14554|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14555|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14556|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14557|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14558|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14559|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14560|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14561|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14562|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14563|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14564|NCT02257918|E3|Reported Event|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
14565|NCT02257918|E2|Reported Event|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
14566|NCT02257918|E1|Reported Event|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
14567|NCT02257385|B3|Baseline|Total|Total of all reporting groups
14568|NCT02257385|B2|Baseline|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14569|NCT02257385|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14570|NCT02257385|P2|Participant Flow|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14571|NCT02257385|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14572|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14573|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14574|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14575|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14576|NCT02257385|E2|Reported Event|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14577|NCT02257385|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
14578|NCT02257372|B3|Baseline|Total|Total of all reporting groups
14579|NCT02257372|B2|Baseline|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
14580|NCT02257372|B1|Baseline|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
14581|NCT02257372|P2|Participant Flow|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
14582|NCT02257372|P1|Participant Flow|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
14583|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
14584|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
14585|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
14586|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
14587|NCT02257372|E2|Reported Event|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
14588|NCT02257372|E1|Reported Event|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed
14589|NCT02256982|B3|Baseline|Total|Total of all reporting groups
14590|NCT02256982|B2|Baseline|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
14591|NCT02256982|B1|Baseline|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
14592|NCT02256982|P2|Participant Flow|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
14593|NCT02256982|P1|Participant Flow|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
14619|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
14992|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
14594|NCT02256982|O2|Outcome|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
14595|NCT02256982|O1|Outcome|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
14596|NCT02256982|E2|Reported Event|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
14597|NCT02256982|E1|Reported Event|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
14598|NCT02256553|B1|Baseline|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14599|NCT02256553|P1|Participant Flow|MK-3641+MK-7243|Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14600|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14601|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14602|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14603|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14604|NCT02256553|E3|Reported Event|Period III: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14605|NCT02256553|E2|Reported Event|Period II: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14606|NCT02256553|E1|Reported Event|Period I: MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
14607|NCT02256488|B5|Baseline|Total|Total of all reporting groups
14608|NCT02256488|B4|Baseline|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
14609|NCT02256488|B3|Baseline|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
14610|NCT02256488|B2|Baseline|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
14611|NCT02256488|B1|Baseline|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
14612|NCT02256488|P4|Participant Flow|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
14613|NCT02256488|P3|Participant Flow|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
14614|NCT02256488|P2|Participant Flow|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
14615|NCT02256488|P1|Participant Flow|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
14616|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
14617|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
14618|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
14620|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
14621|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
14622|NCT02256488|O3|Outcome|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
14623|NCT02256488|O2|Outcome|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
14624|NCT02256488|O1|Outcome|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
14625|NCT02256488|E3|Reported Event|Total|Total number of subjects
14626|NCT02256488|E2|Reported Event|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
14627|NCT02256488|E1|Reported Event|TIVc Pooled|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
14628|NCT02256358|B3|Baseline|Total|Total of all reporting groups
14629|NCT02256358|B2|Baseline|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
14630|NCT02256358|B1|Baseline|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
14631|NCT02256358|P2|Participant Flow|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
14632|NCT02256358|P1|Participant Flow|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
14633|NCT02256358|O2|Outcome|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
14634|NCT02256358|O1|Outcome|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
14635|NCT02256358|E2|Reported Event|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
14636|NCT02256358|E1|Reported Event|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
14637|NCT02256072|B3|Baseline|Total|Total of all reporting groups
14638|NCT02256072|B2|Baseline|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14639|NCT02256072|B1|Baseline|Plan Your Lifespan Website|"Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
14640|NCT02256072|P2|Participant Flow|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14641|NCT02256072|P1|Participant Flow|Plan Your Lifespan Website|Participants in the intervention arm will navigate PlanYourLifespan.org.
14642|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14678|NCT02255279|O1|Outcome|Naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
14679|NCT02255279|E4|Reported Event|Non-naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive).
14643|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making."
14644|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14645|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
14646|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14647|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
14648|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14649|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
14650|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
17845|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
14651|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
14652|NCT02256072|E2|Reported Event|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
14653|NCT02256072|E1|Reported Event|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website."
14654|NCT02255279|B3|Baseline|Total|Total of all reporting groups
14655|NCT02255279|B2|Baseline|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14656|NCT02255279|B1|Baseline|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14657|NCT02255279|P2|Participant Flow|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14658|NCT02255279|P1|Participant Flow|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14659|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14660|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14661|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14662|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14663|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14664|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14665|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14666|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14667|NCT02255279|O2|Outcome|Non naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14668|NCT02255279|O1|Outcome|Non naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14669|NCT02255279|O2|Outcome|Naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14670|NCT02255279|O1|Outcome|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14671|NCT02255279|O2|Outcome|Non-naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14672|NCT02255279|O1|Outcome|Non-naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14673|NCT02255279|O2|Outcome|Naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
14674|NCT02255279|O1|Outcome|Naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
14675|NCT02255279|O2|Outcome|Non-naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
14676|NCT02255279|O1|Outcome|Non-naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
14677|NCT02255279|O2|Outcome|Naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
14680|NCT02255279|E3|Reported Event|Non-naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive).
14681|NCT02255279|E2|Reported Event|Naive_TIV (6 Months to < 72 Months)|"A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive).~Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy."
14682|NCT02255279|E1|Reported Event|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive).
14683|NCT02255149|B1|Baseline|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
14684|NCT02255149|P1|Participant Flow|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
14685|NCT02255149|O1|Outcome|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
14686|NCT02255149|E1|Reported Event|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
14687|NCT02254551|B1|Baseline|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
14688|NCT02254551|P1|Participant Flow|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
14689|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
14690|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
14691|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity"
14692|NCT02254551|E3|Reported Event|Cohort 3: LDE225 800mg/m^2|"Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
14693|NCT02254551|E2|Reported Event|Cohort 2: LDE225 600mg/m^2|Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
14694|NCT02254551|E1|Reported Event|Cohort 1: LDE225 400mg/m^2|"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
14695|NCT02254252|B3|Baseline|Total|Total of all reporting groups
14696|NCT02254252|B2|Baseline|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14697|NCT02254252|B1|Baseline|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14825|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14826|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14698|NCT02254252|P2|Participant Flow|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14699|NCT02254252|P1|Participant Flow|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14700|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14701|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14702|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14703|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14704|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14705|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14706|NCT02254252|E2|Reported Event|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
14707|NCT02254252|E1|Reported Event|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
14708|NCT02253160|B4|Baseline|Total|Total of all reporting groups
14709|NCT02253160|B3|Baseline|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14710|NCT02253160|B2|Baseline|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14711|NCT02253160|B1|Baseline|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
14712|NCT02253160|P3|Participant Flow|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14753|NCT02252965|P1|Participant Flow|Metformin IR|Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14754|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14827|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14713|NCT02253160|P2|Participant Flow|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14714|NCT02253160|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
14715|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14716|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14717|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14718|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14719|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14720|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14721|NCT02253160|O2|Outcome|COBE Spectra|Subjects who received an CMNC collection using the COBE Spectra
14722|NCT02253160|O1|Outcome|Spectra Optia|Subjects who received an CMNC collection using the Spectra Optia
14755|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14828|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14723|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14724|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14725|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14726|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14727|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14728|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14729|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14730|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14731|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14732|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14733|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14734|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14735|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14736|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14737|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14738|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14739|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14740|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14741|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14742|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14743|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14744|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
14745|NCT02253160|E4|Reported Event|Follow up|Subjects who completed cross-over design and were followed for at least 1 day.
14746|NCT02253160|E3|Reported Event|COBE Spectra|Subjects who received COBE Spectra MNC collection procedure.
14747|NCT02253160|E2|Reported Event|Spectra Optia|Subject who received Spectra Optia CMNC collection procedure.
14748|NCT02253160|E1|Reported Event|Pre-collection|Subjects screened and received G-CSF.
14749|NCT02252965|B3|Baseline|Total|Total of all reporting groups
14750|NCT02252965|B2|Baseline|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14751|NCT02252965|B1|Baseline|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14752|NCT02252965|P2|Participant Flow|Metformin XR|Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14823|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
17846|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
14756|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14757|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14758|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14759|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14760|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14761|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14762|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14763|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14764|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14765|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14766|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
14767|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14768|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14769|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14770|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
14771|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14772|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14773|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14774|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14775|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14776|NCT02252965|E3|Reported Event|Metformin IR to XR|Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
14824|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
17847|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
14777|NCT02252965|E2|Reported Event|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
14778|NCT02252965|E1|Reported Event|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
14779|NCT02252744|B1|Baseline|RA Patients|Adult patients diagnosed with rheumatoid arthritis
14780|NCT02252744|P1|Participant Flow|RA Patients|Adult patients diagnosed with rheumatoid arthritis
14781|NCT02252744|O1|Outcome|RA Patients|Adult patients diagnosed with rheumatoid arthritis
14782|NCT02252744|E1|Reported Event|RA Patients|Adult patients diagnosed with rheumatoid arthritis
14783|NCT02252445|B3|Baseline|Total|Total of all reporting groups
14784|NCT02252445|B2|Baseline|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14785|NCT02252445|B1|Baseline|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14786|NCT02252445|P2|Participant Flow|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14787|NCT02252445|P1|Participant Flow|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14788|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14789|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14790|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14791|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14792|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14793|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14794|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14795|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14796|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14797|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14798|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14799|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14800|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14801|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14802|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14803|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14804|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14805|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14806|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14807|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14808|NCT02252445|E2|Reported Event|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
14809|NCT02252445|E1|Reported Event|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
14810|NCT02252354|B3|Baseline|Total|Total of all reporting groups
14811|NCT02252354|B2|Baseline|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14812|NCT02252354|B1|Baseline|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14813|NCT02252354|P2|Participant Flow|Part 2: TAK-385 + [14C]-TAK-385|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14814|NCT02252354|P1|Participant Flow|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14815|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14816|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14817|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14818|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14819|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14820|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14821|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14822|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14829|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14830|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14831|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14832|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14833|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14834|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14835|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14836|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14837|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14838|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14839|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14840|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14841|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14842|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14843|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14844|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14845|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14846|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14847|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14848|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14849|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14850|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14851|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14852|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14853|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14854|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14855|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14856|NCT02252354|E2|Reported Event|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
14857|NCT02252354|E1|Reported Event|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
14858|NCT02252133|B1|Baseline|Overall|DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
14859|NCT02252133|P2|Participant Flow|1DAVTE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
14860|NCT02252133|P1|Participant Flow|DT1, Then 1DAVTE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
14861|NCT02252133|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
14862|NCT02252133|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.
14863|NCT02252133|E2|Reported Event|1DAVTE|All subjects who wore narafilcon A contact lenses
14864|NCT02252133|E1|Reported Event|Dailies Total 1|All subjects who wore delefilcon A contact lenses
14865|NCT02252016|B3|Baseline|Total|Total of all reporting groups
14866|NCT02252016|B2|Baseline|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14867|NCT02252016|B1|Baseline|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14868|NCT02252016|P2|Participant Flow|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14869|NCT02252016|P1|Participant Flow|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14870|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14871|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14872|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14873|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14874|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14875|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14876|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14877|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14878|NCT02252016|E2|Reported Event|Deferred Treatment: Placebo Phase|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
14879|NCT02252016|E1|Reported Event|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
14880|NCT02251886|B5|Baseline|Total|Total of all reporting groups
14881|NCT02251886|B4|Baseline|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
14882|NCT02251886|B3|Baseline|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
14883|NCT02251886|B2|Baseline|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14884|NCT02251886|B1|Baseline|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14885|NCT02251886|P4|Participant Flow|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
14886|NCT02251886|P3|Participant Flow|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
14887|NCT02251886|P2|Participant Flow|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14888|NCT02251886|P1|Participant Flow|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14889|NCT02251886|O4|Outcome|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
14890|NCT02251886|O3|Outcome|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
14891|NCT02251886|O2|Outcome|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14892|NCT02251886|O1|Outcome|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14893|NCT02251886|E4|Reported Event|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
14894|NCT02251886|E3|Reported Event|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
14895|NCT02251886|E2|Reported Event|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14896|NCT02251886|E1|Reported Event|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
14897|NCT02251613|B1|Baseline|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
14898|NCT02251613|P1|Participant Flow|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
14899|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14900|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14901|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14902|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14903|NCT02251613|E2|Reported Event|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14904|NCT02251613|E1|Reported Event|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
14905|NCT02251561|B1|Baseline|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
14979|NCT02248818|B1|Baseline|AZD8108 20 mg - SAD|AZD8108 20 mg SAD, Cohort 1
14980|NCT02248818|P9|Participant Flow|Screen|Screen - no treatment
14906|NCT02251561|P1|Participant Flow|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
14907|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
14908|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
14909|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
14910|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
14911|NCT02251561|E2|Reported Event|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
14912|NCT02251561|E1|Reported Event|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
14913|NCT02250807|B1|Baseline|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14914|NCT02250807|P1|Participant Flow|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14915|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14916|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14917|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14918|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14919|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14920|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14921|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14922|NCT02250807|E1|Reported Event|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
14923|NCT02250274|B3|Baseline|Total|Total of all reporting groups
14924|NCT02250274|B2|Baseline|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14925|NCT02250274|B1|Baseline|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14926|NCT02250274|P2|Participant Flow|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14927|NCT02250274|P1|Participant Flow|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14928|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14929|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14930|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14931|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14932|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14933|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14934|NCT02250274|E2|Reported Event|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
14935|NCT02250274|E1|Reported Event|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
14936|NCT02249728|B1|Baseline|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
14937|NCT02249728|P1|Participant Flow|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14938|NCT02249728|O1|Outcome|Part Two Radiolabelle AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14939|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14940|NCT02249728|O1|Outcome|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
14941|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14942|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14943|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14944|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14945|NCT02249728|E1|Reported Event|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
14946|NCT02249104|B1|Baseline|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14947|NCT02249104|P1|Participant Flow|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14948|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14949|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14950|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14951|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14952|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14953|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14954|NCT02249104|E1|Reported Event|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
14955|NCT02249052|B1|Baseline|AA4500 and Placebo|"single injection of 0.58 mg study drug and placebo~Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
14956|NCT02249052|P1|Participant Flow|Study Drug and Placebo|"Each subject received a single injection of 1 mL containing 0.58 mg study drug in one lipoma and a single injection of 1 mL placebo in another lipoma~Lipoma #1 was randomized to study drug or placebo with Lipoma #2 receiving the alternate intervention"
14957|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
14958|NCT02249052|O1|Outcome|Study Drug|Each participants received a single injection of 1 mL containing 0.58 mg study drug
14959|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
14960|NCT02249052|O1|Outcome|Study Drug|Each subject received a single injection of 1 mL containing 0.58 mg study drug
14961|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
14962|NCT02249052|O1|Outcome|Study Drug|Each subject received a single injection of 1 mL containing 0.58 mg study drug
14963|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
14964|NCT02249052|O1|Outcome|Study Drug|Each participants received a single injection of 1 mL containing 0.58 mg study drug
14965|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
14966|NCT02249052|O1|Outcome|Study Drug|Each subject received a single injection of 1 mL containing 0.58 mg study drug
14967|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
14968|NCT02249052|O1|Outcome|Study Drug|Each subject received a single injection of 1 mL containing 0.58 mg study drug
14969|NCT02249052|E2|Reported Event|Placebo|"single injection of placebo~placebo: Placebo"
14970|NCT02249052|E1|Reported Event|AA4500|"single injection of 0.58 mg study drug~AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
14971|NCT02248818|B9|Baseline|Total|Total of all reporting groups
14972|NCT02248818|B8|Baseline|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
14973|NCT02248818|B7|Baseline|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
14974|NCT02248818|B6|Baseline|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
14975|NCT02248818|B5|Baseline|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
14976|NCT02248818|B4|Baseline|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
14977|NCT02248818|B3|Baseline|AZD8108 95 mg - SAD|AZD8108 95 mg SAD, Cohort 3
14978|NCT02248818|B2|Baseline|AZD8108 60 mg - SAD|AZD8108 60 mg SAD, Cohort 2
14993|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
14994|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
14995|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
14996|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
14997|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
14998|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
14999|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15000|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15001|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15002|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15003|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15004|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15005|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15006|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15007|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15008|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15009|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15010|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15011|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15012|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15013|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15014|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15015|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15016|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15017|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15018|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15019|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15020|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15021|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15022|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15023|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15024|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15025|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15026|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15027|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15028|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15029|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15030|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15031|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15032|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15033|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15034|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15035|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15036|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15037|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15038|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15039|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15040|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15041|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15042|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15043|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15044|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15045|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15046|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15047|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15048|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15049|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15050|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15051|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15052|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15053|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15054|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15055|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15056|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15057|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15058|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15059|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15060|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15061|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15062|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15063|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15064|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15065|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15066|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15067|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15068|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15069|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15070|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15071|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15072|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15073|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15074|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15075|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15076|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15077|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15078|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15079|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15080|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15081|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15082|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15083|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15084|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15085|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15086|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15087|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15088|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15089|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15090|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15091|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15092|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15093|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15094|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15095|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15096|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15097|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15098|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15099|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15100|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15101|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15102|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15103|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15104|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15105|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15106|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15107|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15108|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15109|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15110|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15111|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15112|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15113|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15114|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15115|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15116|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15117|NCT02248818|E8|Reported Event|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
15118|NCT02248818|E7|Reported Event|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
15119|NCT02248818|E6|Reported Event|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
15120|NCT02248818|E5|Reported Event|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
15121|NCT02248818|E4|Reported Event|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
15122|NCT02248818|E3|Reported Event|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
15123|NCT02248818|E2|Reported Event|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
15124|NCT02248818|E1|Reported Event|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
15125|NCT02248766|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15126|NCT02248766|P1|Participant Flow|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15127|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15128|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15129|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15130|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15131|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15132|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15133|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15134|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15135|NCT02248766|E2|Reported Event|Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15136|NCT02248766|E1|Reported Event|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
15137|NCT02248727|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
15138|NCT02248727|P1|Participant Flow|Enfilcon A / Somofilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15139|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15140|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15141|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15142|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15143|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15144|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15145|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15146|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
15147|NCT02248727|E1|Reported Event|Enfilcon A to Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
15148|NCT02248558|B3|Baseline|Total|Total of all reporting groups
15149|NCT02248558|B2|Baseline|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
15150|NCT02248558|B1|Baseline|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
15151|NCT02248558|P2|Participant Flow|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
15152|NCT02248558|P1|Participant Flow|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
15153|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
15154|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
15155|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
15156|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
15157|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
15158|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
15355|NCT02243202|B3|Baseline|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15159|NCT02248558|E2|Reported Event|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
15160|NCT02248558|E1|Reported Event|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
15161|NCT02248480|B3|Baseline|Total|Total of all reporting groups
15162|NCT02248480|B2|Baseline|Placebo|Placebo administered orally once a day for 15 weeks.
15163|NCT02248480|B1|Baseline|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15164|NCT02248480|P2|Participant Flow|Placebo|Placebo administered orally once a day for 15 weeks.
15165|NCT02248480|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15166|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15167|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15168|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15169|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15170|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15171|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15172|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15173|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15174|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15175|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15176|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15177|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15178|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15179|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15180|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15181|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15182|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15183|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15184|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15185|NCT02248480|O1|Outcome|Duloxetine|"Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.~Duloxetine: Administered orally"
15186|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15187|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15188|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15189|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15190|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15191|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15192|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15193|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15194|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15195|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15196|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15197|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15198|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
15356|NCT02243202|B2|Baseline|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15199|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15200|NCT02248480|E2|Reported Event|Placebo|Placebo administered orally once a day for 15 weeks.
15201|NCT02248480|E1|Reported Event|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
15202|NCT02248246|B1|Baseline|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
15203|NCT02248246|P1|Participant Flow|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
15204|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
15205|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
15206|NCT02248246|E1|Reported Event|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
15207|NCT02248103|B3|Baseline|Total|Total of all reporting groups
15208|NCT02248103|B2|Baseline|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15209|NCT02248103|B1|Baseline|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15210|NCT02248103|P2|Participant Flow|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15211|NCT02248103|P1|Participant Flow|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15212|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15213|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15214|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15215|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15216|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15217|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15218|NCT02248103|E2|Reported Event|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
15219|NCT02248103|E1|Reported Event|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
15220|NCT02247011|B3|Baseline|Total|Total of all reporting groups
15221|NCT02247011|B2|Baseline|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15222|NCT02247011|B1|Baseline|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15223|NCT02247011|P1|Participant Flow|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.
15224|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15225|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15226|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15227|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15228|NCT02247011|O2|Outcome|Non-fracture Group|Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15229|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15230|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15231|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15232|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15233|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15234|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15235|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15236|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15237|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
15238|NCT02247011|E1|Reported Event|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.
15239|NCT02246582|B1|Baseline|All Subjects|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15240|NCT02246582|P2|Participant Flow|Group B (FST 14 Hrs After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15241|NCT02246582|P1|Participant Flow|Group A (FST 30 Mins After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15242|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15243|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15244|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15245|NCT02246582|E1|Reported Event|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
15246|NCT02246166|B3|Baseline|Total|Total of all reporting groups
15247|NCT02246166|B2|Baseline|Placebo|Matching placebo tablet
15248|NCT02246166|B1|Baseline|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15249|NCT02246166|P2|Participant Flow|Placebo|Matching placebo tablet
15250|NCT02246166|P1|Participant Flow|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15251|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15252|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15253|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15254|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15255|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15256|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15257|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15258|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15259|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15260|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15261|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15262|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15263|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15264|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15265|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15266|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15267|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15268|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15269|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15270|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15271|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15272|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15273|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15274|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15275|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15276|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15277|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15278|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15279|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
15280|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15281|NCT02246166|E2|Reported Event|Placebo|Matching placebo tablet
15282|NCT02246166|E1|Reported Event|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
15283|NCT02246114|B3|Baseline|Total|Total of all reporting groups
15284|NCT02246114|B2|Baseline|Arm B|CO monitor
15285|NCT02246114|B1|Baseline|Arm A|no CO monitor
15286|NCT02246114|P2|Participant Flow|Arm B|CO monitor
15287|NCT02246114|P1|Participant Flow|Arm A|no CO monitor
15288|NCT02246114|O2|Outcome|Arm B|CO monitor
15289|NCT02246114|O1|Outcome|Arm A|no CO monitor
15290|NCT02246114|E2|Reported Event|Arm B (CO Monitor)|CO monitor
15291|NCT02246114|E1|Reported Event|Arm A (no CO Monitor)|no CO monitor
15292|NCT02246062|B5|Baseline|Total|Total of all reporting groups
15293|NCT02246062|B4|Baseline|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15357|NCT02243202|B1|Baseline|Placebo|Participants received placebo tablets orally for 26 weeks.
15294|NCT02246062|B3|Baseline|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15295|NCT02246062|B2|Baseline|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15296|NCT02246062|B1|Baseline|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15297|NCT02246062|P4|Participant Flow|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15298|NCT02246062|P3|Participant Flow|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15299|NCT02246062|P2|Participant Flow|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15300|NCT02246062|P1|Participant Flow|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15301|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15302|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15303|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15304|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15305|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15306|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15307|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15308|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15309|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15310|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15311|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15312|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15313|NCT02246062|E4|Reported Event|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
15314|NCT02246062|E3|Reported Event|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
15507|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
15315|NCT02246062|E2|Reported Event|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
15316|NCT02246062|E1|Reported Event|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
15317|NCT02245360|B3|Baseline|Total|Total of all reporting groups
15318|NCT02245360|B2|Baseline|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
15319|NCT02245360|B1|Baseline|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
15320|NCT02245360|P2|Participant Flow|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
15321|NCT02245360|P1|Participant Flow|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
15322|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
15323|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
15324|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
15325|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
15326|NCT02245360|E2|Reported Event|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
15327|NCT02245360|E1|Reported Event|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
15328|NCT02244840|B1|Baseline|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
15329|NCT02244840|P1|Participant Flow|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
15330|NCT02244840|O1|Outcome|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
15331|NCT02244840|E1|Reported Event|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
15332|NCT02244580|B1|Baseline|FinHer Patients|"Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).~RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67."
15333|NCT02244580|P1|Participant Flow|MammaTyper™|"MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.~MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67."
15334|NCT02244580|O2|Outcome|OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
15335|NCT02244580|O1|Outcome|DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
15336|NCT02244580|O1|Outcome|Patients With MKI67 mRNA Determination|Patients with low MKI67 mRNA
15337|NCT02244580|O2|Outcome|Combined Subtype|Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
15338|NCT02244580|O1|Outcome|Luminal A|Patients subtyped as Luminal A with DDFS determined 5 years after randomisation
15339|NCT02244580|E1|Reported Event||Since only tumor material was used, adverse events were not documented within the MammaTyper Study
15340|NCT02243943|B3|Baseline|Total|Total of all reporting groups
15341|NCT02243943|B2|Baseline|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15342|NCT02243943|B1|Baseline|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15343|NCT02243943|P2|Participant Flow|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15344|NCT02243943|P1|Participant Flow|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15345|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15346|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15347|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15348|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15349|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15350|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15351|NCT02243943|E2|Reported Event|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
15352|NCT02243943|E1|Reported Event|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
15353|NCT02243202|B5|Baseline|Total|Total of all reporting groups
15354|NCT02243202|B4|Baseline|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
17848|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
15358|NCT02243202|P4|Participant Flow|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15359|NCT02243202|P3|Participant Flow|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15360|NCT02243202|P2|Participant Flow|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15361|NCT02243202|P1|Participant Flow|Placebo|Participants received placebo tablets orally for 26 weeks.
15362|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15363|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15364|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15365|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15366|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15367|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15368|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15369|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15370|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15371|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15372|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15373|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15374|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15375|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15376|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15377|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15378|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15379|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15380|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15381|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15382|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15383|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15384|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15385|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15386|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15387|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15388|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15389|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
15390|NCT02243202|E4|Reported Event|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
15391|NCT02243202|E3|Reported Event|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
15392|NCT02243202|E2|Reported Event|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
15393|NCT02243202|E1|Reported Event|Placebo|Participants received placebo tablets orally for 26 weeks.
15394|NCT02243046|B4|Baseline|Total|Total of all reporting groups
15395|NCT02243046|B3|Baseline|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15396|NCT02243046|B2|Baseline|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15397|NCT02243046|B1|Baseline|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15398|NCT02243046|P3|Participant Flow|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15419|NCT02243046|E3|Reported Event|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
15399|NCT02243046|P2|Participant Flow|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15400|NCT02243046|P1|Participant Flow|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15401|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15402|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15403|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15404|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15405|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15406|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15407|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15408|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15409|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15410|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15411|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15412|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15413|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15414|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15415|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15416|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15417|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15418|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
17849|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
15420|NCT02243046|E2|Reported Event|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15421|NCT02243046|E1|Reported Event|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
15422|NCT02242994|B1|Baseline|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
15423|NCT02242994|P1|Participant Flow|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
15424|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
15425|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
15426|NCT02242994|E1|Reported Event|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
15427|NCT02242643|B3|Baseline|Total|Total of all reporting groups
15428|NCT02242643|B2|Baseline|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15429|NCT02242643|B1|Baseline|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15430|NCT02242643|P2|Participant Flow|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15431|NCT02242643|P1|Participant Flow|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15432|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15433|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15434|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15435|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15436|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15437|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15505|NCT02240368|P2|Participant Flow|Group 2|Children age between 13 months and 36 months
15506|NCT02240368|P1|Participant Flow|Group 1|Children age between 1 month to 12 months
15438|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15439|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15440|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15441|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15442|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15443|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15444|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15445|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15446|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15447|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15448|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15449|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15450|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15451|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
15452|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15453|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15454|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15455|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
17850|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
15456|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15457|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15458|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15459|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15460|NCT02242643|E2|Reported Event|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15461|NCT02242643|E1|Reported Event|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
15462|NCT02242630|B5|Baseline|Total|Total of all reporting groups
15463|NCT02242630|B4|Baseline|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
15464|NCT02242630|B3|Baseline|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15465|NCT02242630|B2|Baseline|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15466|NCT02242630|B1|Baseline|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15467|NCT02242630|P4|Participant Flow|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
15468|NCT02242630|P3|Participant Flow|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15469|NCT02242630|P2|Participant Flow|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15470|NCT02242630|P1|Participant Flow|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15471|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
15472|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15473|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15474|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15475|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
15476|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15477|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15478|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15479|NCT02242630|E4|Reported Event|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
15480|NCT02242630|E3|Reported Event|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15481|NCT02242630|E2|Reported Event|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15482|NCT02242630|E1|Reported Event|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
15483|NCT02242019|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15484|NCT02242019|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15485|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15486|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15487|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15488|NCT02242019|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
15489|NCT02240628|B3|Baseline|Total|Total of all reporting groups
15490|NCT02240628|B2|Baseline|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
15491|NCT02240628|B1|Baseline|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
15492|NCT02240628|P2|Participant Flow|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
15493|NCT02240628|P1|Participant Flow|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
15494|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
15495|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
15496|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
15497|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
15498|NCT02240628|E2|Reported Event|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
15499|NCT02240628|E1|Reported Event|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
15500|NCT02240368|B4|Baseline|Total|Total of all reporting groups
15501|NCT02240368|B3|Baseline|Group 3|Children age between 37 months to 144 months
15502|NCT02240368|B2|Baseline|Group 2|Children age between 13 months and 36 months
15503|NCT02240368|B1|Baseline|Group 1|Children age between 1 month to 12 months
15504|NCT02240368|P3|Participant Flow|Group 3|Children age between 37 months to 144 months
15508|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
15509|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
15510|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
15511|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
15512|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
15513|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
15514|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
15515|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
15516|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
15517|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
15518|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
15519|NCT02240368|E3|Reported Event|Group 3|Children age between 37 months to 144 months
15520|NCT02240368|E2|Reported Event|Group 2|Children age between 13 months and 36 months
15521|NCT02240368|E1|Reported Event|Group 1|Children age between 1 month to 12 months
15522|NCT02240329|B1|Baseline|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
15523|NCT02240329|P1|Participant Flow|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
15524|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
15525|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
15526|NCT02240329|E1|Reported Event|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
15527|NCT02239926|B3|Baseline|Total|Total of all reporting groups
15528|NCT02239926|B2|Baseline|Placebo|Placebo
15529|NCT02239926|B1|Baseline|Ranolazine|tablet, 1000 mg twice daily for four weeks
15530|NCT02239926|P2|Participant Flow|Placebo|Placebo
15531|NCT02239926|P1|Participant Flow|Ranolazine|tablet, 1000 mg twice daily for four weeks
15532|NCT02239926|O2|Outcome|Placebo|Placebo
15533|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
15534|NCT02239926|O2|Outcome|Placebo|Placebo
15535|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
15536|NCT02239926|E2|Reported Event|Placebo|Placebo
15537|NCT02239926|E1|Reported Event|Ranolazine|tablet, 1000 mg twice daily for four weeks
15538|NCT02239744|B3|Baseline|Total|Total of all reporting groups
15539|NCT02239744|B2|Baseline|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15540|NCT02239744|B1|Baseline|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
15541|NCT02239744|P2|Participant Flow|True Purifiers First, Then Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.
15542|NCT02239744|P1|Participant Flow|Sham Purifiers First, Then True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.
15543|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15544|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
15545|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15546|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
15547|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15548|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
15549|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15550|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
15551|NCT02239744|E2|Reported Event|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
15552|NCT02239744|E1|Reported Event|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
15553|NCT02239692|B3|Baseline|Total|Total of all reporting groups
15554|NCT02239692|B2|Baseline|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15555|NCT02239692|B1|Baseline|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15556|NCT02239692|P2|Participant Flow|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15557|NCT02239692|P1|Participant Flow|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15558|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15559|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15560|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15561|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15562|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15563|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15564|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15565|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15566|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15567|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15568|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15569|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15570|NCT02239692|E2|Reported Event|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15571|NCT02239692|E1|Reported Event|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
15572|NCT02239289|B1|Baseline|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15573|NCT02239289|P1|Participant Flow|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15574|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
17851|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
15575|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15576|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15577|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15578|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15579|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15580|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15581|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15582|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15583|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15584|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15585|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15586|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15587|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15588|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15589|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15590|NCT02239289|E1|Reported Event|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
15591|NCT02238782|B1|Baseline|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
15592|NCT02238782|P1|Participant Flow|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
15593|NCT02238782|O1|Outcome|Selumetinib|Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
15594|NCT02238782|E1|Reported Event|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
15595|NCT02238067|B1|Baseline|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15596|NCT02238067|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with Chronic Kidney Disease (CKD) who were not on dialysis and treated with Erythropoiesis-Stimulating Agents (ESA) according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15597|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15598|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15599|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15600|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15601|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15602|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15603|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15604|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15605|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15606|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15607|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15608|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15609|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15610|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15611|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15612|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15613|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15614|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15615|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15616|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15617|NCT02238067|E1|Reported Event|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
15618|NCT02238028|B1|Baseline|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15619|NCT02238028|P2|Participant Flow|Not Wearing Respirator First,Then Wearing Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15620|NCT02238028|P1|Participant Flow|Wearing Respirator First,Then Not Wearing Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15621|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15689|NCT02235831|E2|Reported Event|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
15690|NCT02235831|E1|Reported Event|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
15622|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15623|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15624|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15625|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15626|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15627|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15628|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15629|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15630|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15631|NCT02238028|O1|Outcome|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15632|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15660|NCT02236611|B2|Baseline|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
15691|NCT02235493|B1|Baseline|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
15633|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15634|NCT02238028|O2|Outcome|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15635|NCT02238028|O1|Outcome|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15636|NCT02238028|E2|Reported Event|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
15637|NCT02238028|E1|Reported Event|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
15638|NCT02237092|B1|Baseline|Measurement of IAP|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.
15639|NCT02237092|P1|Participant Flow|Measurement of IAP|"The data obtained are in inches of water column were translated in millimeters of mercury.~Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration."
15640|NCT02237092|O2|Outcome|Level of IAP = > 16 mm Hg|number of pregnant women with Level of IAP = > 16 mm Hg
15641|NCT02237092|O1|Outcome|Level of IAP < 16 mm Hg|number of pregnant women with Level of IAP < 16 mm Hg
15642|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
15643|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
15644|NCT02237092|O2|Outcome|Obesity|BMI = > 30.00
15645|NCT02237092|O1|Outcome|No Obesity|BMI < = 29.99
15646|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
15647|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
15648|NCT02237092|O4|Outcome|Grade III|(21 - 25.99 mm Hg)
15649|NCT02237092|O3|Outcome|Grade II|(16 - 20.99 mm Hg)
15650|NCT02237092|O2|Outcome|Grade I|(12 - 15.99 mm Hg)
15651|NCT02237092|O1|Outcome|Physiological Norm|(≤11,99 mm Hg)
15652|NCT02237092|O1|Outcome|Intra-abdominal Pressure (IAP) in Pregnant Women|Average IAP in pregnant women
15653|NCT02237092|E2|Reported Event|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
15654|NCT02237092|E1|Reported Event|Level of Sensory Block => Th4 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
15655|NCT02236767|B1|Baseline|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
15656|NCT02236767|P1|Participant Flow|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
15657|NCT02236767|O1|Outcome|rTMS Treatment|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
15658|NCT02236767|E1|Reported Event|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
15659|NCT02236611|B3|Baseline|Total|Total of all reporting groups
15661|NCT02236611|B1|Baseline|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
15662|NCT02236611|P2|Participant Flow|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
15663|NCT02236611|P1|Participant Flow|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
15664|NCT02236611|O2|Outcome|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
15665|NCT02236611|O1|Outcome|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
15666|NCT02236611|E2|Reported Event|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
15667|NCT02236611|E1|Reported Event|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
15668|NCT02236130|B3|Baseline|Total|Total of all reporting groups
15669|NCT02236130|B2|Baseline|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15670|NCT02236130|B1|Baseline|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15671|NCT02236130|P2|Participant Flow|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15672|NCT02236130|P1|Participant Flow|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15673|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15674|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15675|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15676|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15677|NCT02236130|E2|Reported Event|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15678|NCT02236130|E1|Reported Event|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
15679|NCT02235831|B1|Baseline|Overall|DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
15680|NCT02235831|P6|Participant Flow|Seq 6|DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15681|NCT02235831|P5|Participant Flow|Seq 5|DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15682|NCT02235831|P4|Participant Flow|Seq 4|DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15683|NCT02235831|P3|Participant Flow|Seq 3|DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15684|NCT02235831|P2|Participant Flow|Seq 2|DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15685|NCT02235831|P1|Participant Flow|Seq I|DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
15686|NCT02235831|O2|Outcome|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
15687|NCT02235831|O1|Outcome|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
15688|NCT02235831|E3|Reported Event|DACP MF (Low Add)|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
15692|NCT02235493|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
15693|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
15694|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
15695|NCT02235493|E1|Reported Event|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
15696|NCT02235285|B1|Baseline|All Study Participants|Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
15697|NCT02235285|P1|Participant Flow|Breast Augmentation,Reoperation|The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
15698|NCT02235285|O1|Outcome|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
15699|NCT02235285|E1|Reported Event|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
15700|NCT02234479|B3|Baseline|Total|Total of all reporting groups
15701|NCT02234479|B2|Baseline|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
15702|NCT02234479|B1|Baseline|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
15703|NCT02234479|P2|Participant Flow|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
15704|NCT02234479|P1|Participant Flow|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
15705|NCT02234479|O2|Outcome|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
15706|NCT02234479|O1|Outcome|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
15707|NCT02234479|E2|Reported Event|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
15708|NCT02234479|E1|Reported Event|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
15709|NCT02234427|B1|Baseline|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
15710|NCT02234427|P1|Participant Flow|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
15711|NCT02234427|O1|Outcome|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
15712|NCT02234427|E1|Reported Event|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
15713|NCT02233998|B4|Baseline|Total|Total of all reporting groups
15714|NCT02233998|B3|Baseline|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15715|NCT02233998|B2|Baseline|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15716|NCT02233998|B1|Baseline|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15717|NCT02233998|P3|Participant Flow|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15718|NCT02233998|P2|Participant Flow|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15719|NCT02233998|P1|Participant Flow|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15720|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15721|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15722|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15723|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15724|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15725|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15726|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15727|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15728|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15729|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15730|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15731|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15732|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15733|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15734|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15735|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15736|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15737|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15738|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15739|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15740|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15741|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15742|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15743|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15744|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15745|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15746|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
15747|NCT02233998|E3|Reported Event|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
15748|NCT02233998|E2|Reported Event|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
15749|NCT02233998|E1|Reported Event|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
17852|NCT02204579|O1|Outcome|NPSP795|
15750|NCT02233842|B1|Baseline|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products"
15751|NCT02233842|P1|Participant Flow|Tobacco Use in Cancer Patients and Survivors|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
15752|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
15753|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
15754|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
15755|NCT02233842|O1|Outcome|All Participants|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
15756|NCT02233842|E1|Reported Event|Tobacco Use in Cancer Patients and Survivors|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
15757|NCT02233647|B1|Baseline|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15758|NCT02233647|P1|Participant Flow|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
15759|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15760|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15761|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15762|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15763|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15823|NCT02232126|O2|Outcome|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
15824|NCT02232126|O1|Outcome|Usual Care|Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.
15764|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15765|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15766|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15767|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15768|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15769|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15770|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15771|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15772|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15773|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15774|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15775|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15776|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15777|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15778|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15779|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15780|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15781|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15782|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15783|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15784|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
15785|NCT02233647|E1|Reported Event|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
15786|NCT02233309|B1|Baseline|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
15787|NCT02233309|P1|Participant Flow|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
17853|NCT02204579|O1|Outcome|NPSP795|
15788|NCT02233309|O1|Outcome|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
15789|NCT02233309|E1|Reported Event|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
15790|NCT02233296|B3|Baseline|Total|Total of all reporting groups
15791|NCT02233296|B2|Baseline|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
15792|NCT02233296|B1|Baseline|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
15793|NCT02233296|P2|Participant Flow|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
15794|NCT02233296|P1|Participant Flow|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
15795|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15796|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15797|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15798|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15799|NCT02233296|O2|Outcome|Fasted Condition (n=30)|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
15800|NCT02233296|O1|Outcome|Fed Condition (n=30)|Data presented is all subjects in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
15801|NCT02233296|O2|Outcome|Fasted Condition|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
15802|NCT02233296|O1|Outcome|Fed Condition|Data presented is all subjects in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).
15803|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15804|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15805|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15806|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
15807|NCT02233296|E2|Reported Event|Fasted Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fasted condition are considered equally.
15808|NCT02233296|E1|Reported Event|Fed Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fed condition are considered equally.
15809|NCT02232880|B1|Baseline|Consented Patients|No patients received treatment prior to study termination
15810|NCT02232880|P1|Participant Flow|Consented Patients|
15811|NCT02232880|O1|Outcome|Consented Patients|
15812|NCT02232880|O1|Outcome|Consented Patients|
15813|NCT02232880|O1|Outcome|Consented Patients|
15814|NCT02232880|O1|Outcome|Consented Patients|
15815|NCT02232880|E1|Reported Event|Consented Patients|No patients received treatment prior to study termination
15816|NCT02232126|B3|Baseline|Total|Total of all reporting groups
15817|NCT02232126|B2|Baseline|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
15818|NCT02232126|B1|Baseline|Usual Care|Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital
15819|NCT02232126|P2|Participant Flow|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
15820|NCT02232126|P1|Participant Flow|Usual Care|
15821|NCT02232126|O2|Outcome|Intervention Group: Opt-outs|Patients randomized to the intervention group that refused the intervention.
15822|NCT02232126|O1|Outcome|Intervention Group: Received Intervention|Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
15860|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15825|NCT02232126|E2|Reported Event|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
15826|NCT02232126|E1|Reported Event|Usual Care|Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.
15827|NCT02231918|B4|Baseline|Total|Total of all reporting groups
15828|NCT02231918|B3|Baseline|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15829|NCT02231918|B2|Baseline|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15830|NCT02231918|B1|Baseline|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15831|NCT02231918|P3|Participant Flow|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15832|NCT02231918|P2|Participant Flow|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15833|NCT02231918|P1|Participant Flow|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15834|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15835|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15836|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15837|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15838|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15839|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15840|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15841|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15842|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15843|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15844|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15845|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15846|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15847|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15848|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15849|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15850|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15851|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15852|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15853|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15854|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15855|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15856|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15857|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15858|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15859|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15977|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
17854|NCT02204579|O1|Outcome|NPSP795|
15861|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15862|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15863|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15864|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15865|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15866|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15867|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15868|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15869|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15870|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15871|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15872|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15873|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15874|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15875|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15876|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15877|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15878|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15879|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15880|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15881|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15882|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15883|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15884|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15885|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15886|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15887|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15888|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15889|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15890|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15891|NCT02231918|E3|Reported Event|MIRAPEX® (0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
15892|NCT02231918|E2|Reported Event|MIRAPEX® (0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
15893|NCT02231918|E1|Reported Event|MIRAPEX® (0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
15894|NCT02231177|B1|Baseline|All Subjects|"A randomised, active-controlled, double-blind, 3-way crossover study in patients with COPD (chronic obstructive pulmonary disease). All participants received each of the three treatment arms in a randomly assigned order, the three treatments, which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg.~Tiotropium 5 µg."
17855|NCT02204579|O1|Outcome|NPSP795|
15895|NCT02231177|P6|Participant Flow|Tio 5 μg, Olo 10 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
15896|NCT02231177|P5|Participant Flow|Tio 5 μg, Tio+Olo 5/10 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg."
15897|NCT02231177|P4|Participant Flow|Olo 10 μg, Tio 5 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
15898|NCT02231177|P3|Participant Flow|Olo 10 μg, Tio+Olo 5/10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg."
15899|NCT02231177|P2|Participant Flow|Tio+Olo 5/10 μg, Tio 5 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg.~Olodaterol 10 µg."
15900|NCT02231177|P1|Participant Flow|Tio+Olo 5/10 μg, Olo 10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol (Olo) 10 µg.~Tiotropium (Tio) 5 µg."
15901|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15902|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15903|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15904|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15905|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15906|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15907|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15908|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15909|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15910|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15911|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15912|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15913|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15914|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15915|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15916|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15917|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15918|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15919|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15920|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15921|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15978|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15922|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15923|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15924|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15925|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15926|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15927|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15928|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15929|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15930|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15931|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15932|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15933|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15934|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15935|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15936|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15937|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15938|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15939|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15940|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15941|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15942|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15943|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15944|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15945|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15946|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15947|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15948|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15949|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15950|NCT02231177|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15951|NCT02231177|E2|Reported Event|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15952|NCT02231177|E1|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
15953|NCT02231164|B3|Baseline|Total|Total of all reporting groups
15954|NCT02231164|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15955|NCT02231164|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15956|NCT02231164|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15957|NCT02231164|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15958|NCT02231164|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15959|NCT02231164|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15960|NCT02231164|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15961|NCT02231164|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
15962|NCT02230904|B3|Baseline|Total Title|
15963|NCT02230904|B2|Baseline|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
15964|NCT02230904|B1|Baseline|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
15965|NCT02230904|P2|Participant Flow|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
15966|NCT02230904|P1|Participant Flow|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
15967|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
15968|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
15969|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
15970|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15971|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
15972|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15973|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
15974|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15975|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
15976|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15979|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
15980|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
15981|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
15982|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
15983|NCT02230904|E2|Reported Event|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
15984|NCT02230904|E1|Reported Event|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
15985|NCT02230761|B3|Baseline|Total|Total of all reporting groups
15986|NCT02230761|B2|Baseline|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15987|NCT02230761|B1|Baseline|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15988|NCT02230761|P2|Participant Flow|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15989|NCT02230761|P1|Participant Flow|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15990|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15991|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15992|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15993|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15994|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15995|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15996|NCT02230761|E2|Reported Event|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
15997|NCT02230761|E1|Reported Event|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
15998|NCT02230683|B1|Baseline|IDN-6556|IDN-6556 25 mg Dosed twice daily
15999|NCT02230683|P1|Participant Flow|IDN-6556|IDN-6556 25 mg Dosed twice daily
16000|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
16001|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
16002|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
16003|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16004|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16005|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
16006|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16007|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with Baseline HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16008|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
16009|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16010|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
16011|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
16012|NCT02230683|E1|Reported Event|IDN-6556|IDN-6556 25 mg Dosed twice daily
16013|NCT02230540|B1|Baseline|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
16014|NCT02230540|P2|Participant Flow|Sequence B|"Based on results from sequence A, sequence B may or may not be initiated.~Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product B in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices)."
16015|NCT02230540|P1|Participant Flow|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
16016|NCT02230540|O1|Outcome|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
16045|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
17856|NCT02204579|E1|Reported Event|NPSP795|
16017|NCT02230540|E1|Reported Event|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
16018|NCT02230085|B1|Baseline|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
16019|NCT02230085|P1|Participant Flow|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
16020|NCT02230085|O1|Outcome|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
16021|NCT02230085|E1|Reported Event|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
16022|NCT02229864|B1|Baseline|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
16023|NCT02229864|P1|Participant Flow|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
16024|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16025|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16026|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16027|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16028|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16029|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16030|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16031|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16032|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16033|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16034|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16035|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16036|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16037|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16038|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16039|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16040|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16041|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16042|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16043|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16044|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
17857|NCT02204449|B3|Baseline|Total|Total of all reporting groups
16046|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16047|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16048|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16049|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16050|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16051|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16052|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16053|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16054|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16055|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16056|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16057|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16058|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
16059|NCT02229864|E1|Reported Event|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
16060|NCT02229513|B3|Baseline|Total|Total of all reporting groups
16061|NCT02229513|B2|Baseline|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16062|NCT02229513|B1|Baseline|Control|Normal cesarean technique.
16063|NCT02229513|P2|Participant Flow|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16064|NCT02229513|P1|Participant Flow|Control|Normal cesarean technique.
16065|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16066|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16067|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16068|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16069|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16070|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16206|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16071|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16072|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16073|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16074|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16075|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16076|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16077|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16078|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16079|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16080|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16081|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16082|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16083|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16084|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16085|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16086|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16087|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16088|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16089|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16090|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16091|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16092|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16207|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16093|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16094|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
16095|NCT02229513|E2|Reported Event|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16096|NCT02229513|E1|Reported Event|Control|Normal cesarean technique.
16097|NCT02229461|B8|Baseline|Total|Total of all reporting groups
16098|NCT02229461|B7|Baseline|Non-Randomized|Fifteen participants were not randomized into Treatment Period.
16099|NCT02229461|B6|Baseline|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16100|NCT02229461|B5|Baseline|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16101|NCT02229461|B4|Baseline|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16102|NCT02229461|B3|Baseline|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16103|NCT02229461|B2|Baseline|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16104|NCT02229461|B1|Baseline|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16105|NCT02229461|P6|Participant Flow|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16106|NCT02229461|P5|Participant Flow|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16107|NCT02229461|P4|Participant Flow|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16108|NCT02229461|P3|Participant Flow|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16109|NCT02229461|P2|Participant Flow|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16110|NCT02229461|P1|Participant Flow|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16111|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16112|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16113|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16114|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16371|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16115|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16116|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16117|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16118|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16119|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16120|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16121|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16122|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16123|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16124|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16125|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16126|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16127|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16128|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16129|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16130|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16131|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16132|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16133|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16134|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16208|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
26758|NCT02100475|B3|Baseline|Total|Total of all reporting groups
16135|NCT02229461|E7|Reported Event|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16136|NCT02229461|E6|Reported Event|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16137|NCT02229461|E5|Reported Event|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16138|NCT02229461|E4|Reported Event|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16139|NCT02229461|E3|Reported Event|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16140|NCT02229461|E2|Reported Event|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
16141|NCT02229461|E1|Reported Event|Group 0-IR ASA 81 mg qd in Run-in Period|Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
16142|NCT02229318|B1|Baseline|FruitiVits|Daily administration of FruitiVits dietary supplement
16143|NCT02229318|P1|Participant Flow|FruitiVits|Daily administration of FruitiVits dietary supplement
16144|NCT02229318|O1|Outcome|FruitiVits|Administration of FruitiVits dietary supplement
16145|NCT02229318|O1|Outcome|FruitiVits|Daily administration of FruitiVits dietary supplement
16146|NCT02229318|E1|Reported Event|FruitiVits|Daily administration of FruitiVits dietary supplement
16147|NCT02229214|B3|Baseline|Total|Total of all reporting groups
16148|NCT02229214|B2|Baseline|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
16149|NCT02229214|B1|Baseline|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16150|NCT02229214|P2|Participant Flow|Placebo|"Days 1-28: Placebo~Sugar Pill"
16151|NCT02229214|P1|Participant Flow|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16152|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
16153|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16154|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
16155|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16156|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
16157|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16158|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
16159|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16160|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
16161|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16162|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
16163|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16164|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
16165|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16166|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
16167|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16168|NCT02229214|E2|Reported Event|Placebo|"Days 1-28: Placebo~Sugar Pill"
16209|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
26781|NCT02100410|O6|Outcome|TEST6|Iteration 2-87-3 without embossed mark
16169|NCT02229214|E1|Reported Event|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
16170|NCT02228980|B5|Baseline|Total|Total of all reporting groups
16171|NCT02228980|B4|Baseline|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16172|NCT02228980|B3|Baseline|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16173|NCT02228980|B2|Baseline|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16174|NCT02228980|B1|Baseline|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16175|NCT02228980|P4|Participant Flow|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16176|NCT02228980|P3|Participant Flow|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16177|NCT02228980|P2|Participant Flow|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16178|NCT02228980|P1|Participant Flow|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16179|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16180|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16181|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16182|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16183|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16184|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16185|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16186|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16187|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16188|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16189|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16190|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16191|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16192|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
16193|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
16194|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16195|NCT02228980|E4|Reported Event|Group 4|Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
16196|NCT02228980|E3|Reported Event|Group 3|Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
16197|NCT02228980|E2|Reported Event|Group 2|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
16198|NCT02228980|E1|Reported Event|Group 1|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
16199|NCT02228395|B1|Baseline|All Participants|Included all participants who received at least 1 dose of study treatment in any of the intervention periods
16200|NCT02228395|P3|Participant Flow|PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo|Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
16201|NCT02228395|P2|Participant Flow|PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg|Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
16202|NCT02228395|P1|Participant Flow|Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg|Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
16203|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16204|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16205|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16372|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16210|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16211|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16212|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16213|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16214|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16215|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16216|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16217|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16218|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16219|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16220|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16221|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16222|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16223|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16224|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16225|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16226|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16227|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16228|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16229|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16230|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16231|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16232|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16233|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16234|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16235|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16236|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16237|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16238|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16239|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16240|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16241|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16242|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16243|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16244|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16245|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16246|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16247|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16248|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16249|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16250|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16251|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16252|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16253|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16254|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16255|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16256|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16257|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16258|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16259|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16260|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16261|NCT02228395|E4|Reported Event|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
16262|NCT02228395|E3|Reported Event|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
16263|NCT02228395|E2|Reported Event|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
16264|NCT02228395|E1|Reported Event|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
16265|NCT02227485|B3|Baseline|Total|Total of all reporting groups
16266|NCT02227485|B2|Baseline|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16267|NCT02227485|B1|Baseline|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16268|NCT02227485|P2|Participant Flow|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16269|NCT02227485|P1|Participant Flow|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16270|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16271|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16272|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16273|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16274|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16275|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16276|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16311|NCT02226549|P1|Participant Flow|LDV/SOF+VDV|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
16373|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16277|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16278|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16279|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16280|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16281|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16282|NCT02227485|E2|Reported Event|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16283|NCT02227485|E1|Reported Event|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
16284|NCT02227121|B1|Baseline|Enrolled Subjects|All subjects consented for the study.
16285|NCT02227121|P1|Participant Flow|Enrolled Subjects|All subjects consented for the study.
16286|NCT02227121|O1|Outcome|VF Induction and Defibrillation|"Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.~Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator."
16287|NCT02227121|E1|Reported Event|Enrolled Subjects|All subjects consented into the study
16288|NCT02226562|B3|Baseline|Total|Total of all reporting groups
16289|NCT02226562|B2|Baseline|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16290|NCT02226562|B1|Baseline|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16291|NCT02226562|P2|Participant Flow|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16292|NCT02226562|P1|Participant Flow|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16293|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16294|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16295|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16296|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16297|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16298|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16299|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16300|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16301|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16302|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16303|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16304|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16305|NCT02226562|E2|Reported Event|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
16306|NCT02226562|E1|Reported Event|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
16307|NCT02226549|B3|Baseline|Total|Total of all reporting groups
16308|NCT02226549|B2|Baseline|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16309|NCT02226549|B1|Baseline|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
16310|NCT02226549|P2|Participant Flow|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16370|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16312|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16313|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
16314|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16315|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
16316|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16317|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
16318|NCT02226549|E2|Reported Event|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
16319|NCT02226549|E1|Reported Event|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
16320|NCT02226198|B1|Baseline|Cross-over|Cross-over phase
16321|NCT02226198|P3|Participant Flow|Placebo First Then Rosuva|Relevant for the cross-over phase
16322|NCT02226198|P2|Participant Flow|Rosuva First Then Placebo|Relevant for the cross-over phase
16323|NCT02226198|P1|Participant Flow|Overall|Relevant for the lead-in and maintenance phases
16324|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
16325|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16326|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
16327|NCT02226198|O3|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16328|NCT02226198|O2|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16329|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
16330|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16331|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
16332|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16333|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16334|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16335|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16336|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16337|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16338|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16339|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16340|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16341|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16342|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16343|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16344|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16345|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
16346|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16347|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
16348|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16349|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
16350|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
16351|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
16352|NCT02226198|O4|Outcome|Pla/Ros >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
16353|NCT02226198|O3|Outcome|Pla/Ros <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
16354|NCT02226198|O2|Outcome|Ros/Pla >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
16355|NCT02226198|O1|Outcome|Ros/Pla <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
16356|NCT02226198|O3|Outcome|Maintenance Phase|Maintenance phase, Safety analysis set
16357|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
16358|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
16359|NCT02226198|O3|Outcome|Maintenance|Maintenance Phase, Safety analysis set
16360|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
16361|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
16362|NCT02226198|O2|Outcome|Maintenance Phase|Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
16363|NCT02226198|O1|Outcome|Cross-over Phase|Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
16364|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
16365|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
16366|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
16367|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
16368|NCT02226198|O2|Outcome|C-FAS Placebo Not on Apheresis|Cross-over Full Analysis Set, 6 weeks of Placebo
16369|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16374|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16375|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16376|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16377|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16378|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16379|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16380|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16381|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16382|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16383|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16384|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16385|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16386|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16387|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16388|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16389|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16390|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
16391|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
16392|NCT02226198|E3|Reported Event|Maintenance|Maintenance phase
16393|NCT02226198|E2|Reported Event|Cross-over|Cross-over phase
16394|NCT02226198|E1|Reported Event|Lead-in|Lead-in
16395|NCT02224820|B1|Baseline|Intravenous IdeS|"One or two doses of IdeS in ascending doses~IdeS"
16396|NCT02224820|P1|Participant Flow|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16397|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16398|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16399|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16400|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16401|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16402|NCT02224820|E1|Reported Event|Intravenous IdeS|One or two doses of IdeS in ascending doses.
16403|NCT02224625|B1|Baseline|2% CHG, Vehicle, DynaHex, Saline|Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
16404|NCT02224625|P1|Participant Flow|2% CHG Cloth, Vehicle, DynaHex, Saline, SLS|Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
16405|NCT02224625|O5|Outcome|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
16406|NCT02224625|O4|Outcome|Saline|"0.9% sodium chloride~Saline: Negative control"
16407|NCT02224625|O3|Outcome|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
16408|NCT02224625|O2|Outcome|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
16409|NCT02224625|O1|Outcome|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
16410|NCT02224625|E5|Reported Event|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
16411|NCT02224625|E4|Reported Event|Saline|"0.9% sodium chloride~Saline: Negative control"
16412|NCT02224625|E3|Reported Event|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
16413|NCT02224625|E2|Reported Event|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
16414|NCT02224625|E1|Reported Event|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
16415|NCT02224404|B1|Baseline|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
16416|NCT02224404|P1|Participant Flow|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
16417|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
16418|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
16419|NCT02224404|E1|Reported Event|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
16420|NCT02224053|B1|Baseline|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
16421|NCT02224053|P1|Participant Flow|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
16422|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16423|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16424|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16425|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16426|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16427|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16428|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16429|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16430|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
26782|NCT02100410|O5|Outcome|TEST5|Iteration 2-87-3 with embossed mark
16431|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16432|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16433|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16434|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16435|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16436|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16437|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16438|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16439|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16440|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16441|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16442|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16443|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16444|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16445|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16446|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16447|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16448|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16449|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16450|NCT02224053|E2|Reported Event|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
16451|NCT02224053|E1|Reported Event|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
16452|NCT02223871|B1|Baseline|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes occurred 16 days after ACT-451840 administration (or earlier if required).
16453|NCT02223871|P1|Participant Flow|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16454|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16455|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16456|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16457|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16458|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16459|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16500|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16501|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
26783|NCT02100410|O4|Outcome|TEST4|Iteration 2-87-2 without embossed mark
16460|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16461|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16462|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
16463|NCT02223871|E1|Reported Event|ACT-451840 500 mg|The eight subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes on Day 0 and received 500 mg of ACT-451840 on Day 7. All of them received six doses of Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, as per protocol.
16464|NCT02223754|B3|Baseline|Total|Total of all reporting groups
16465|NCT02223754|B2|Baseline|Lotrafilcon B / Etafilcon A|Subjects that were randomized to this sequence and were dispensed a study lens.
16466|NCT02223754|B1|Baseline|Etafilcon A / Lotrafilcon B|Subjects that were randomized to this sequence and were dispensed a study lens.
16467|NCT02223754|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
16468|NCT02223754|P1|Participant Flow|Etafilcon A / Lotrafilcon B|Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
16469|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
16470|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16471|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16472|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16473|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16474|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16475|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16476|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16477|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16478|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16479|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16480|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16481|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
16482|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16483|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16484|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16485|NCT02223754|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
16486|NCT02223754|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
16487|NCT02223715|B1|Baseline|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
16488|NCT02223715|P1|Participant Flow|Clostridium Difficile Infection|To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
16489|NCT02223715|O1|Outcome|Recurrence or Not After 2 Months Follow-up|
16490|NCT02223715|O1|Outcome|Clinical Complication|
16491|NCT02223715|O1|Outcome|Status at the End of CDI Episode|To characterize the management and outcome of Clostridium Difficile Infection
16492|NCT02223715|O1|Outcome|Medical History|To characterize the management and outcome of Clostridium Difficile Infection
16493|NCT02223715|E1|Reported Event|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
16494|NCT02223650|B3|Baseline|Total|Total of all reporting groups
16495|NCT02223650|B2|Baseline|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16496|NCT02223650|B1|Baseline|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16497|NCT02223650|P2|Participant Flow|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16498|NCT02223650|P1|Participant Flow|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16499|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16502|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16503|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16504|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16505|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
16506|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
16507|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16508|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16509|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16510|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16511|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16512|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16513|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
16514|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
16515|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16516|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16517|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16518|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16519|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16520|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16521|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16522|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16523|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16524|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16525|NCT02223650|E2|Reported Event|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
16526|NCT02223650|E1|Reported Event|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
16527|NCT02223260|B1|Baseline|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16528|NCT02223260|P1|Participant Flow|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16529|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16530|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16531|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16532|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16533|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16534|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16535|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16570|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16536|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16537|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16538|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16539|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16540|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16541|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16542|NCT02223260|E1|Reported Event|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
16543|NCT02223065|B3|Baseline|Total|Total of all reporting groups
16544|NCT02223065|B2|Baseline|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
16545|NCT02223065|B1|Baseline|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
16546|NCT02223065|P2|Participant Flow|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
16547|NCT02223065|P1|Participant Flow|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
16548|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16549|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16550|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16551|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16552|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16553|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16554|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16555|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16556|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16557|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16558|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16559|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16560|NCT02223065|E2|Reported Event|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
16561|NCT02223065|E1|Reported Event|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
16562|NCT02222870|B3|Baseline|Total|Total of all reporting groups
16563|NCT02222870|B2|Baseline|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16564|NCT02222870|B1|Baseline|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16565|NCT02222870|P2|Participant Flow|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16566|NCT02222870|P1|Participant Flow|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16567|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16568|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16569|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
18270|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
16571|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16572|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16573|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16574|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16575|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16576|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16577|NCT02222870|E2|Reported Event|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16578|NCT02222870|E1|Reported Event|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
16579|NCT02222818|B3|Baseline|Total|Total of all reporting groups
16580|NCT02222818|B2|Baseline|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
16581|NCT02222818|B1|Baseline|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
16582|NCT02222818|P2|Participant Flow|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
16583|NCT02222818|P1|Participant Flow|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
16584|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
16585|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
16586|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
16587|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
16588|NCT02222818|E1|Reported Event|All Enrolled Subjects|All subjects enrolled in the CRTee study.
16589|NCT02222558|B1|Baseline|All Study Participants|"Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.~Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16590|NCT02222558|P6|Participant Flow|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16591|NCT02222558|P5|Participant Flow|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16592|NCT02222558|P4|Participant Flow|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16657|NCT02220998|B2|Baseline|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16593|NCT02222558|P3|Participant Flow|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16594|NCT02222558|P2|Participant Flow|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
16595|NCT02222558|P1|Participant Flow|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
16596|NCT02222558|O6|Outcome|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16597|NCT02222558|O5|Outcome|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16598|NCT02222558|O4|Outcome|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16599|NCT02222558|O3|Outcome|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16600|NCT02222558|O2|Outcome|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
16601|NCT02222558|O1|Outcome|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
16602|NCT02222558|E6|Reported Event|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16603|NCT02222558|E5|Reported Event|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16604|NCT02222558|E4|Reported Event|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16605|NCT02222558|E3|Reported Event|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
16606|NCT02222558|E2|Reported Event|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
16607|NCT02222558|E1|Reported Event|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
16608|NCT02222207|B1|Baseline|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16609|NCT02222207|P1|Participant Flow|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16610|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16611|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16612|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16658|NCT02220998|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
26784|NCT02100410|O3|Outcome|TEST3|Iteration 2-87-2 with embossed mark
16613|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16614|NCT02222207|E1|Reported Event|Part A Regorafenib|Participants self-administered 30 mg/mL, 25 mcL, 1 drop of regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
16615|NCT02222181|B1|Baseline|Treatment|patients in treatment for Alzheimer's disease.
16616|NCT02222181|P1|Participant Flow|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16617|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16618|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16619|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16620|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16621|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16622|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16623|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
16624|NCT02222181|E1|Reported Event|Treatment|Do not apply.
16625|NCT02222129|B3|Baseline|Total|Total of all reporting groups
16626|NCT02222129|B2|Baseline|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
16627|NCT02222129|B1|Baseline|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
16628|NCT02222129|P2|Participant Flow|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
16629|NCT02222129|P1|Participant Flow|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
16630|NCT02222129|O2|Outcome|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
16631|NCT02222129|O1|Outcome|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
16632|NCT02222129|E2|Reported Event|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
16633|NCT02222129|E1|Reported Event|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
16634|NCT02221947|B3|Baseline|Total|Total of all reporting groups
16635|NCT02221947|B2|Baseline|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
16636|NCT02221947|B1|Baseline|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
16637|NCT02221947|P2|Participant Flow|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
16638|NCT02221947|P1|Participant Flow|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
16639|NCT02221947|O2|Outcome|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
16640|NCT02221947|O1|Outcome|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
16641|NCT02221947|E2|Reported Event|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
16642|NCT02221947|E1|Reported Event|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
16643|NCT02221648|B3|Baseline|Total|Total of all reporting groups
16644|NCT02221648|B2|Baseline|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
16645|NCT02221648|B1|Baseline|Placebo|Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
16646|NCT02221648|P2|Participant Flow|ArbobotulinumtoxinA Treatment|"Subjects will receive intervention injections with the study drug abobotulinumtoxinA.~AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment."
16647|NCT02221648|P1|Participant Flow|Placebo|Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
16648|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|"Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.~AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA."
16649|NCT02221648|O1|Outcome|Placebo|"Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.~Placebo: Subjects will be randomization to receive either the study drug or the placebo group."
16650|NCT02221648|O2|Outcome|botulinumtoxinA Treatment|Subjects received botox injection.
16651|NCT02221648|O1|Outcome|Placebo|Study group received placebo injection.
16652|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
16653|NCT02221648|O1|Outcome|Placebo|Subjects will be randomized to receive injections with saline.
16654|NCT02221648|E2|Reported Event|ArbobotulinumtoxinA Treatment|AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
16655|NCT02221648|E1|Reported Event|Placebo|Subjects will be randomized to receive injections with placebo.
16656|NCT02220998|B3|Baseline|Total|Total of all reporting groups
16659|NCT02220998|P2|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16660|NCT02220998|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
16661|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16662|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16663|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16664|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16665|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16666|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16667|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16668|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16669|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16670|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16671|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16672|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16673|NCT02220998|E2|Reported Event|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
16674|NCT02220998|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
16675|NCT02220920|B3|Baseline|Total|Total of all reporting groups
16676|NCT02220920|B2|Baseline|Placebo＋Insulin|Placebo, once daily for 16 weeks
16677|NCT02220920|B1|Baseline|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16678|NCT02220920|P2|Participant Flow|Placebo＋Insulin|Placebo, once daily for 16 weeks
16679|NCT02220920|P1|Participant Flow|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16680|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
16681|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16682|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
16683|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16684|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
16685|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16686|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
16687|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16688|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
16689|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16690|NCT02220920|E2|Reported Event|Placebo＋Insulin|Placebo, once daily for 16 weeks
16691|NCT02220920|E1|Reported Event|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
16692|NCT02220764|B3|Baseline|Total|Total of all reporting groups
16693|NCT02220764|B2|Baseline|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16694|NCT02220764|B1|Baseline|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16695|NCT02220764|P2|Participant Flow|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16696|NCT02220764|P1|Participant Flow|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16697|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16698|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16699|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16700|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16701|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16702|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16703|NCT02220764|E2|Reported Event|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
16704|NCT02220764|E1|Reported Event|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
16705|NCT02219997|B3|Baseline|Total|Total of all reporting groups
16706|NCT02219997|B2|Baseline|Clear IOL|Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
16707|NCT02219997|B1|Baseline|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
16708|NCT02219997|P3|Participant Flow|Clear IOL: Placebo Filter First, Then BLF|Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
16709|NCT02219997|P2|Participant Flow|Clear IOL: BLF First, Then Placebo Filter|Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
16710|NCT02219997|P1|Participant Flow|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
16711|NCT02219997|O2|Outcome|Clear IOL + BLF|Clear IOL with clip-on glasses with blue light filtering properties
16712|NCT02219997|O1|Outcome|ACRYSOF IQ IOL + Placebo Filter|ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo
16713|NCT02219997|O2|Outcome|Blue Light Filter|Clear IOL with clip-on glasses with blue light filtering properties
16714|NCT02219997|O1|Outcome|Placebo Filter|Clear IOLs with placebo colored clip-on filters
16715|NCT02219997|O2|Outcome|Clear IOL|Clear IOL without filters
16716|NCT02219997|O1|Outcome|AcrySof IQ IOL|ACRYSOF® IQ IOL without filters
16717|NCT02219997|E3|Reported Event|Clear IOL|All subjects implanted with Clear IOLs from time of initiation of experimental testing
16718|NCT02219997|E2|Reported Event|AcrySof IQ IOL|All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing
16719|NCT02219997|E1|Reported Event|Pre-treatment|All subjects from time to consent until initiation of experimental testing
16720|NCT02219685|B3|Baseline|Total|Total of all reporting groups
16721|NCT02219685|B2|Baseline|Placebo|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
16722|NCT02219685|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
16723|NCT02219685|P2|Participant Flow|Placebo, Followed by Open-Label LDV/SOF|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
16724|NCT02219685|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
16725|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16726|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16727|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16728|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16729|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16730|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16731|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16732|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16733|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16734|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16735|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16736|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16737|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16738|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16739|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16740|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16741|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16742|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16743|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16744|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16745|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16746|NCT02219685|O2|Outcome|Open-Label Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
16747|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16748|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16749|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16750|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16751|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16752|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16753|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16754|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16755|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16756|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16757|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16758|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16759|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16760|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16761|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
18271|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
16762|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
16763|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
16764|NCT02219685|E3|Reported Event|LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
16765|NCT02219685|E2|Reported Event|Placebo (Blinded Phase)|LDV/SOF placebo tablet once daily for 12 weeks
16766|NCT02219685|E1|Reported Event|LDV/SOF (Blinded Phase)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
16767|NCT02219503|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16768|NCT02219503|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16769|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16770|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16771|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16772|NCT02219503|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
16773|NCT02218268|B1|Baseline|All Participants|This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
16774|NCT02218268|P2|Participant Flow|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
16775|NCT02218268|P1|Participant Flow|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
16776|NCT02218268|O2|Outcome|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
16777|NCT02218268|O1|Outcome|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
16778|NCT02218268|E2|Reported Event|No Meal Bolus Then Pre-meal Bolus|A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.
16779|NCT02218268|E1|Reported Event|Pre-meal Bolus Then No Meal Bolus|A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
16780|NCT02217982|B3|Baseline|Total|Total of all reporting groups
17016|NCT02212834|O1|Outcome|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
16781|NCT02217982|B2|Baseline|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
16782|NCT02217982|B1|Baseline|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
16783|NCT02217982|P2|Participant Flow|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
16784|NCT02217982|P1|Participant Flow|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
16785|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
16786|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
16787|NCT02217982|E2|Reported Event|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
16788|NCT02217982|E1|Reported Event|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
16789|NCT02217878|B3|Baseline|Total|Total of all reporting groups
16790|NCT02217878|B2|Baseline|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
16791|NCT02217878|B1|Baseline|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
16792|NCT02217878|P2|Participant Flow|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
16793|NCT02217878|P1|Participant Flow|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
16794|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
16795|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
16796|NCT02217878|E2|Reported Event|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
16797|NCT02217878|E1|Reported Event|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
16798|NCT02216695|B1|Baseline|Acute Kidney Injury|we analysed acute kidney injury requiring dialysis in England
16799|NCT02216695|P1|Participant Flow|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
16800|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|The associations between discharge status was tested with multivariable regression model which included age group and discharge period,
16801|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|Age was categorized into the groups 65, 65–74, 75–84, and > 85. The associations between discharge status was tested with multivariable regression model which included gender, age group, discharge period, admission method, CCS, ethnicity, and AKI in diagnoses code.
16802|NCT02216695|O1|Outcome|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
16803|NCT02216695|O3|Outcome|2008-13|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
16804|NCT02216695|O2|Outcome|2003-08|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
16805|NCT02216695|O1|Outcome|1998-03|All patients who had acute kidney injury and required dialysis between 1998 and 2013 were identified from hospital episode statistic.Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
16806|NCT02216695|E1|Reported Event|Dialysis Requiring AKI|AKI patients who required renal replacement therapy
16807|NCT02216422|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16962|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16808|NCT02216422|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16809|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16810|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16811|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16812|NCT02216422|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
16813|NCT02216097|B3|Baseline|Total|Total of all reporting groups
16814|NCT02216097|B2|Baseline|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16815|NCT02216097|B1|Baseline|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16816|NCT02216097|P2|Participant Flow|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16817|NCT02216097|P1|Participant Flow|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16818|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16819|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16820|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16821|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16822|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16823|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16824|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16825|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16826|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16827|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16828|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16829|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16830|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16831|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16832|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16833|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16834|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16835|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16836|NCT02216097|E2|Reported Event|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
16837|NCT02216097|E1|Reported Event|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
16838|NCT02214225|B4|Baseline|Total|Total of all reporting groups
16839|NCT02214225|B3|Baseline|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
16840|NCT02214225|B2|Baseline|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
16841|NCT02214225|B1|Baseline|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle."
16842|NCT02214225|P3|Participant Flow|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16843|NCT02214225|P2|Participant Flow|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16963|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
18272|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
16844|NCT02214225|P1|Participant Flow|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16845|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16846|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16847|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16848|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16849|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16850|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16851|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16852|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16853|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16854|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16855|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16856|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16857|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
16858|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
16859|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
16860|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
16861|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
16862|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
16863|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
16864|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
16865|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
16866|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
16867|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
16868|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
16869|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
16870|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
16871|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
16872|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
16873|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
16874|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
16875|NCT02214225|O6|Outcome|bioCSL TIV-2 (B/VIC) (≥ 65 Years)|
16876|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
16877|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
16878|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
16879|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
16880|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
17332|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
16881|NCT02214225|O2|Outcome|SCR: Pooled TIV-1 or TIV-2|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to <65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to <65 years, n=424.~B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430."
16882|NCT02214225|O1|Outcome|SCR: bioCSL QIV|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to <65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856."
16883|NCT02214225|O2|Outcome|Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)|B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.
16884|NCT02214225|O1|Outcome|Postvaccination GMT: bioCSL QIV|bioCSL QIV, Adults 18 years and older, N=1691. 18 to < 65 years, n=835. => 65 years, n=856.
16885|NCT02214225|O4|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
16886|NCT02214225|O3|Outcome|SCR: bioCSL QIV (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
16887|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
16888|NCT02214225|O1|Outcome|SCR: bioCSL QIV (18 to < 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421."
16889|NCT02214225|O4|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.
16890|NCT02214225|O3|Outcome|GMT: bioCSL QIV (≥ 65 Years)|Postvaccination GMT. bioCSL QIV, n=856.
16891|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.
16892|NCT02214225|O1|Outcome|GMT: bioCSL QIV (18 to <65 Years)|Postvaccination GMT. bioCSL QIV, n=835.
16893|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.
16894|NCT02214225|O1|Outcome|SCR: bioCSL QIV|bioCSL QIV, n=1691.
16895|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|"Postvaccination GMT.~Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850."
16896|NCT02214225|O1|Outcome|GMT: bioCSL QIV|Postvaccination GMT.
16897|NCT02214225|E3|Reported Event|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
16898|NCT02214225|E2|Reported Event|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
16899|NCT02214225|E1|Reported Event|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
16900|NCT02214186|B3|Baseline|Total|Total of all reporting groups
16901|NCT02214186|B2|Baseline|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16902|NCT02214186|B1|Baseline|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16903|NCT02214186|P2|Participant Flow|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16904|NCT02214186|P1|Participant Flow|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16905|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16906|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16964|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
26785|NCT02100410|O2|Outcome|TEST2|Iteration 2-87-1 without embossed mark
16907|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16908|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16909|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16910|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16911|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16912|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16913|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16914|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16915|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16916|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16917|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16918|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16919|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16920|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16921|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16922|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16923|NCT02214186|E2|Reported Event|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
16924|NCT02214186|E1|Reported Event|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
16925|NCT02213510|B3|Baseline|Total|Total of all reporting groups
16926|NCT02213510|B2|Baseline|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16927|NCT02213510|B1|Baseline|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16928|NCT02213510|P2|Participant Flow|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16965|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16966|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
18273|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
16929|NCT02213510|P1|Participant Flow|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16930|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16931|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16932|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16933|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16934|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16935|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16936|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16937|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16938|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16939|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16940|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16941|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16942|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16967|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16968|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16943|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16944|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16945|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16946|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16947|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16948|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16949|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16950|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16951|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16952|NCT02213510|E2|Reported Event|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
16953|NCT02213510|E1|Reported Event|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
16954|NCT02213250|B1|Baseline|All Participants|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16955|NCT02213250|P2|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16956|NCT02213250|P1|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16957|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16958|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16959|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16960|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16961|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16969|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16970|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16971|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16972|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16973|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16974|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16975|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16976|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16977|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16978|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; Age Group>=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16979|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16980|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16981|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16982|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16983|NCT02213250|E1|Reported Event|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
16984|NCT02213055|B3|Baseline|Total|Total of all reporting groups
16985|NCT02213055|B2|Baseline|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application."
16986|NCT02213055|B1|Baseline|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
16987|NCT02213055|P2|Participant Flow|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
16988|NCT02213055|P1|Participant Flow|LICEMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
17012|NCT02212834|B1|Baseline|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
17013|NCT02212834|P2|Participant Flow|Breast MRI|Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
17014|NCT02212834|P1|Participant Flow|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
17015|NCT02212834|O2|Outcome|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
16989|NCT02213055|O2|Outcome|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application."
16990|NCT02213055|O1|Outcome|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
16991|NCT02213055|E2|Reported Event|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
16992|NCT02213055|E1|Reported Event|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
16993|NCT02212977|B3|Baseline|Total|Total of all reporting groups
16994|NCT02212977|B2|Baseline|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
16995|NCT02212977|B1|Baseline|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
16996|NCT02212977|P2|Participant Flow|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
16997|NCT02212977|P1|Participant Flow|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
16998|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
16999|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17000|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
17001|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17002|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
17003|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17004|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
17005|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17006|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
17007|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17008|NCT02212977|E2|Reported Event|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
17009|NCT02212977|E1|Reported Event|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
17010|NCT02212834|B3|Baseline|Total|Total of all reporting groups
17011|NCT02212834|B2|Baseline|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
26786|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
17017|NCT02212834|E2|Reported Event|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
17018|NCT02212834|E1|Reported Event|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
17019|NCT02212301|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one lens throughout the duration of the study.
17020|NCT02212301|P2|Participant Flow|Lotrafilcon B / Senofilcon A|Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
17021|NCT02212301|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.
17022|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
17023|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
17024|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B in either the first or second period of the study.
17025|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
17026|NCT02212301|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
17027|NCT02212301|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
17028|NCT02212197|B4|Baseline|Total|Total of all reporting groups
17029|NCT02212197|B3|Baseline|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17030|NCT02212197|B2|Baseline|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17031|NCT02212197|B1|Baseline|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17032|NCT02212197|P3|Participant Flow|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17033|NCT02212197|P2|Participant Flow|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17034|NCT02212197|P1|Participant Flow|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17035|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17036|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17037|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17038|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17039|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17040|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17041|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17042|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17043|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17044|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17045|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17046|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17047|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17048|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17049|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17050|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
17051|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
17052|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
17053|NCT02212197|E3|Reported Event|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
17054|NCT02212197|E2|Reported Event|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
17055|NCT02212197|E1|Reported Event|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
17056|NCT02212106|B3|Baseline|Total|Total of all reporting groups
17057|NCT02212106|B2|Baseline|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17153|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
26787|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
17058|NCT02212106|B1|Baseline|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17059|NCT02212106|P2|Participant Flow|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17060|NCT02212106|P1|Participant Flow|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17061|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17062|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17063|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17064|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17065|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17066|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17067|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17068|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17069|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17070|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17071|NCT02212106|O1|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17072|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17154|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
26788|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
17073|NCT02212106|E2|Reported Event|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17074|NCT02212106|E1|Reported Event|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
17075|NCT02212028|B3|Baseline|Total|Total of all reporting groups
17076|NCT02212028|B2|Baseline|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
17077|NCT02212028|B1|Baseline|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
17078|NCT02212028|P2|Participant Flow|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
17079|NCT02212028|P1|Participant Flow|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
17080|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
17081|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
17082|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
17083|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
17084|NCT02212028|E2|Reported Event|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
17085|NCT02212028|E1|Reported Event|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
17086|NCT02210091|B3|Baseline|Total|Total of all reporting groups
17087|NCT02210091|B2|Baseline|6 to <12 Years Old|
17088|NCT02210091|B1|Baseline|<6 Years Old|
17089|NCT02210091|P2|Participant Flow|6 to <12 Years Old|
17090|NCT02210091|P1|Participant Flow|<6 Years Old|
17091|NCT02210091|O1|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17092|NCT02210091|O3|Outcome|Full Analysis Set|
17093|NCT02210091|O2|Outcome|6 to <12 Years Old|
17094|NCT02210091|O1|Outcome|<6 Years Old|
17095|NCT02210091|O3|Outcome|Full Analysis Set|
17096|NCT02210091|O2|Outcome|6 to <12 Years Old|
17097|NCT02210091|O1|Outcome|<6 Years Old|
17098|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17099|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17100|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17101|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17102|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17103|NCT02210091|O1|Outcome|PK Analysis Set <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17104|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17105|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17106|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17107|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17108|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17214|NCT02209766|E1|Reported Event|2 g D4884 Japanese|
17215|NCT02209506|B6|Baseline|Total|Total of all reporting groups
17109|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17110|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17111|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17112|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17113|NCT02210091|O1|Outcome|Overall Study Arm|
17114|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17115|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years olde who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17116|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
17117|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17118|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17119|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17120|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17121|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17122|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17123|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17124|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17125|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17126|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17127|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17128|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17129|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17130|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17131|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17132|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855.
17133|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17134|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
17135|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17136|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17137|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17138|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17139|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17140|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17141|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17142|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17143|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17144|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17145|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17146|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17147|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17148|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17149|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17150|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17151|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17152|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17155|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
17156|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
17157|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
17158|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
17159|NCT02210091|E2|Reported Event|ADVATE Received Before BAX 855|Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study.
17160|NCT02210091|E1|Reported Event|BAX 855 Safety Analysis Set|Participants who received at least 1 dose of BAX 855.
17161|NCT02209766|B5|Baseline|Total|Total of all reporting groups
17162|NCT02209766|B4|Baseline|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
17163|NCT02209766|B3|Baseline|4 g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
17164|NCT02209766|B2|Baseline|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17165|NCT02209766|B1|Baseline|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17166|NCT02209766|P5|Participant Flow|4g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
17167|NCT02209766|P4|Participant Flow|4g D5844 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
17168|NCT02209766|P3|Participant Flow|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17169|NCT02209766|P2|Participant Flow|2 g D5884 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
17170|NCT02209766|P1|Participant Flow|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17171|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17172|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17173|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17174|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17175|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17176|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17177|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17178|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17179|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17180|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17181|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17182|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17183|NCT02209766|O4|Outcome|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
17184|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17185|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17186|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17187|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17188|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17189|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17190|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17191|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17192|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17193|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17194|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17195|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17196|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17197|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17198|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17199|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17200|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17201|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17202|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17203|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17204|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17205|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17206|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17207|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17208|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
17209|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17210|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
17211|NCT02209766|E4|Reported Event|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
17212|NCT02209766|E3|Reported Event|4 g D4884 Caucasian|
17213|NCT02209766|E2|Reported Event|4 g D4884 Japanese|
17216|NCT02209506|B5|Baseline|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17217|NCT02209506|B4|Baseline|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17218|NCT02209506|B3|Baseline|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17219|NCT02209506|B2|Baseline|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17220|NCT02209506|B1|Baseline|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17221|NCT02209506|P5|Participant Flow|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17222|NCT02209506|P4|Participant Flow|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17223|NCT02209506|P3|Participant Flow|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17224|NCT02209506|P2|Participant Flow|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17225|NCT02209506|P1|Participant Flow|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17226|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17227|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17228|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17229|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17230|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17231|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17232|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17233|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17234|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17235|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17236|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17237|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17238|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17239|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17331|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
18274|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
17240|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17241|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17242|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17243|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17244|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17245|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17246|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17247|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17248|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17249|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17250|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17251|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17252|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17253|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17254|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17255|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17256|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17257|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17258|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17259|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17260|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17261|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17262|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17263|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17264|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17265|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17266|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17267|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17268|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17269|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17270|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17271|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17272|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17273|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17274|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17275|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17276|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17277|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17278|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17279|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17280|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17281|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17282|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17283|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17284|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17285|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17286|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17287|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17288|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17289|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17290|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17291|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17292|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17293|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17294|NCT02209506|E5|Reported Event|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17295|NCT02209506|E4|Reported Event|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17296|NCT02209506|E3|Reported Event|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17297|NCT02209506|E2|Reported Event|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17298|NCT02209506|E1|Reported Event|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
17299|NCT02209454|B1|Baseline|Entire Study Population|Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
17300|NCT02209454|P2|Participant Flow|Test IMP First, Then Reference IMP|25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
17301|NCT02209454|P1|Participant Flow|Reference IMP First, Then Test IMP|25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
17302|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17303|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17304|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17305|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17306|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17307|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17308|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17309|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17310|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17311|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17312|NCT02209454|E2|Reported Event|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
17313|NCT02209454|E1|Reported Event|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
17314|NCT02209181|B5|Baseline|Total|Total of all reporting groups
17315|NCT02209181|B4|Baseline|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17316|NCT02209181|B3|Baseline|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17317|NCT02209181|B2|Baseline|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17318|NCT02209181|B1|Baseline|Placebo|Three placebo capsules taken orally
17319|NCT02209181|P4|Participant Flow|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17320|NCT02209181|P3|Participant Flow|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17321|NCT02209181|P2|Participant Flow|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17322|NCT02209181|P1|Participant Flow|Placebo|Three placebo capsules taken orally
17323|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17324|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17325|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17326|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17327|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17328|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17329|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17330|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
18275|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
17333|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17334|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17335|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17336|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17337|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17338|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17339|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17340|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17341|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17342|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17343|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17344|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17345|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17346|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17347|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17348|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17349|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17350|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17351|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17352|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17353|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17354|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17355|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17356|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17357|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17358|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17359|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17360|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17361|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17362|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17363|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17364|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17365|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17366|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17367|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17368|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17369|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17370|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17371|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17372|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17373|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17374|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17375|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17376|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17377|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17378|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17379|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17380|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17381|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17382|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17383|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17384|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17385|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17386|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17387|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17388|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
26789|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
17389|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17390|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17391|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17392|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17393|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17394|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17395|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17396|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17397|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17398|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17399|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17400|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17401|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17402|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17403|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17404|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17405|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17406|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17407|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17408|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17409|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17410|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17411|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17412|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17413|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17414|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17415|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17416|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17417|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17418|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17419|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17420|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17421|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17422|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17423|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17424|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17425|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17426|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17427|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17428|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17429|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17430|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17431|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17432|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17433|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17434|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17435|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17436|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17437|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17438|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17439|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17440|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17441|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17442|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17443|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17444|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
27642|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
17445|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17446|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17447|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17448|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17449|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17450|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17451|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17452|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17453|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17454|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17455|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17456|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17457|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17458|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17459|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17460|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17461|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17462|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17463|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17464|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17465|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17466|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17467|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17468|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17469|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17470|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17471|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17472|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17473|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17474|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17475|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17476|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17477|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17478|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
17479|NCT02209181|E4|Reported Event|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
17480|NCT02209181|E3|Reported Event|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
17481|NCT02209181|E2|Reported Event|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
17482|NCT02209181|E1|Reported Event|Placebo|Three placebo capsules taken orally
17483|NCT02209064|B1|Baseline|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17484|NCT02209064|P1|Participant Flow|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17485|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17486|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17487|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17488|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17489|NCT02209064|E1|Reported Event|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
17490|NCT02207907|B3|Baseline|Total|Total of all reporting groups
17491|NCT02207907|B2|Baseline|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
27643|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
17492|NCT02207907|B1|Baseline|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17493|NCT02207907|P2|Participant Flow|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17494|NCT02207907|P1|Participant Flow|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17495|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17496|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17497|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17498|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17499|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17500|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17501|NCT02207907|O2|Outcome|0% Sodium Bicarbonate|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17502|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17503|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17504|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17505|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17506|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17507|NCT02207907|E2|Reported Event|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17508|NCT02207907|E1|Reported Event|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17509|NCT02207829|B3|Baseline|Total|Total of all reporting groups
17510|NCT02207829|B2|Baseline|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
17511|NCT02207829|B1|Baseline|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
17512|NCT02207829|P2|Participant Flow|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
17513|NCT02207829|P1|Participant Flow|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
17514|NCT02207829|O2|Outcome|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
17515|NCT02207829|O1|Outcome|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
17516|NCT02207829|E2|Reported Event|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
17517|NCT02207829|E1|Reported Event|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
17518|NCT02207608|B3|Baseline|Total|Total of all reporting groups
17519|NCT02207608|B2|Baseline|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
17520|NCT02207608|B1|Baseline|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
17521|NCT02207608|P2|Participant Flow|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
17522|NCT02207608|P1|Participant Flow|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
17523|NCT02207608|O2|Outcome|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
17524|NCT02207608|O1|Outcome|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
17525|NCT02207608|E2|Reported Event|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
17526|NCT02207608|E1|Reported Event|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
17527|NCT02207478|B3|Baseline|Total|Total of all reporting groups
17528|NCT02207478|B2|Baseline|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17529|NCT02207478|B1|Baseline|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17530|NCT02207478|P2|Participant Flow|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17531|NCT02207478|P1|Participant Flow|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.~ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17532|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17533|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17534|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17535|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17536|NCT02207478|E2|Reported Event|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17537|NCT02207478|E1|Reported Event|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
17538|NCT02207413|B7|Baseline|Total|Total of all reporting groups
17539|NCT02207413|B6|Baseline|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17540|NCT02207413|B5|Baseline|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17657|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
17541|NCT02207413|B4|Baseline|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17542|NCT02207413|B3|Baseline|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17543|NCT02207413|B2|Baseline|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17544|NCT02207413|B1|Baseline|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17545|NCT02207413|P6|Participant Flow|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17546|NCT02207413|P5|Participant Flow|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17547|NCT02207413|P4|Participant Flow|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17548|NCT02207413|P3|Participant Flow|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17549|NCT02207413|P2|Participant Flow|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17550|NCT02207413|P1|Participant Flow|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17551|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17552|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17553|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17658|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
27818|NCT02091466|B3|Baseline|Total|Total of all reporting groups
17554|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17555|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17556|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17557|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17558|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17559|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17560|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17561|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17562|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17563|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17628|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17660|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17564|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17565|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6m-<5y Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17566|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6m-<5y Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17567|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17568|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17569|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17570|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17571|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17572|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17573|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17629|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
18059|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
17574|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17575|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17576|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17577|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17578|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17579|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17580|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17581|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17582|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17583|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17584|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17630|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17659|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
17585|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17586|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17587|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17588|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17589|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17590|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17591|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17592|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17593|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17594|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17595|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17596|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17597|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17598|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17599|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17655|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
17656|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17600|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17601|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17602|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17603|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17604|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17605|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17606|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17607|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17608|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17609|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17610|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17611|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17612|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17613|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17614|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17615|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17616|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17617|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17618|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17619|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17620|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17621|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17622|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17623|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17624|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17625|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17626|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17627|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17631|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17632|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17633|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17634|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17635|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17636|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17637|NCT02207413|E6|Reported Event|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17638|NCT02207413|E5|Reported Event|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
17639|NCT02207413|E4|Reported Event|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17640|NCT02207413|E3|Reported Event|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
17641|NCT02207413|E2|Reported Event|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17642|NCT02207413|E1|Reported Event|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
17643|NCT02207400|B3|Baseline|Total|Total of all reporting groups
17644|NCT02207400|B2|Baseline|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17645|NCT02207400|B1|Baseline|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
17646|NCT02207400|P2|Participant Flow|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17647|NCT02207400|P1|Participant Flow|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
17648|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17649|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
17650|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17651|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
17652|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17653|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
17654|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17661|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
17662|NCT02207400|E2|Reported Event|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
17663|NCT02207400|E1|Reported Event|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
17664|NCT02206607|B1|Baseline|All Participants|Participants received at least 1 dose of PF-04937319.
17665|NCT02206607|P5|Participant Flow|Sequence DCAB: PF-04937319 330 mg MR3 First|Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.
17666|NCT02206607|P4|Participant Flow|Sequence CBDA: PF-04937319 300 mg MR2 First|Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.
17667|NCT02206607|P3|Participant Flow|Sequence BACD: PF-04937319 250 mg MR1 First|Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.
17668|NCT02206607|P2|Participant Flow|Sequence ADBC: PF-04937319 150+100 mg IR First|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.
17669|NCT02206607|P1|Participant Flow|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.
17670|NCT02206607|O5|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17671|NCT02206607|O4|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17672|NCT02206607|O3|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17673|NCT02206607|O2|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17674|NCT02206607|O1|Outcome|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
17675|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17676|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17677|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17678|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17679|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17680|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17681|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17682|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17683|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17684|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17685|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17686|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17687|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17688|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
18060|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18276|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
17689|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17690|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17691|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17692|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17693|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17694|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17695|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17696|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17697|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17698|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17699|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17700|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17701|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17702|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17703|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17704|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17705|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17706|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17707|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17708|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17709|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17710|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17711|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17712|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17713|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17714|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17715|NCT02206607|E5|Reported Event|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17716|NCT02206607|E4|Reported Event|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
17717|NCT02206607|E3|Reported Event|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
18061|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
17718|NCT02206607|E2|Reported Event|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
17719|NCT02206607|E1|Reported Event|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
17720|NCT02205814|B5|Baseline|Total|Total of all reporting groups
17721|NCT02205814|B4|Baseline|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17722|NCT02205814|B3|Baseline|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17723|NCT02205814|B2|Baseline|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17724|NCT02205814|B1|Baseline|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17725|NCT02205814|P4|Participant Flow|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17726|NCT02205814|P3|Participant Flow|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17727|NCT02205814|P2|Participant Flow|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17728|NCT02205814|P1|Participant Flow|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17729|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17730|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17731|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17732|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17733|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17734|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17735|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17736|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17737|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17738|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17739|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17740|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17741|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17742|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17743|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17744|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17745|NCT02205814|E4|Reported Event|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
17746|NCT02205814|E3|Reported Event|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
17747|NCT02205814|E2|Reported Event|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
17748|NCT02205814|E1|Reported Event|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
17749|NCT02205476|B3|Baseline|Total|Total of all reporting groups
17750|NCT02205476|B2|Baseline|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17751|NCT02205476|B1|Baseline|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17786|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17752|NCT02205476|P2|Participant Flow|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17753|NCT02205476|P1|Participant Flow|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17754|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17755|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17756|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17757|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17758|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17759|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17760|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17761|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17762|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17763|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
17764|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17765|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17766|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17787|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17767|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17768|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17769|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17770|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17771|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17772|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17773|NCT02205476|O3|Outcome|Group 2: PF-06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17774|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17775|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17776|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17777|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17778|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
17779|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17780|NCT02205476|E2|Reported Event|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17781|NCT02205476|E1|Reported Event|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
17782|NCT02204748|B1|Baseline|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17783|NCT02204748|P1|Participant Flow|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17784|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17785|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17831|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
17832|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17833|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17788|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17789|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17790|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17791|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17792|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17793|NCT02204748|E1|Reported Event|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
17794|NCT02204657|B3|Baseline|Total|Total of all reporting groups
17795|NCT02204657|B2|Baseline|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
17796|NCT02204657|B1|Baseline|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
17797|NCT02204657|P2|Participant Flow|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
17798|NCT02204657|P1|Participant Flow|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
17799|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
17800|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
17801|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
17802|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
17803|NCT02204657|E2|Reported Event|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
17804|NCT02204657|E1|Reported Event|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
17805|NCT02204579|B1|Baseline|NPSP795|
17806|NCT02204579|P1|Participant Flow|NPSP795|
17807|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17808|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17809|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
17810|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
17811|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
17812|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17813|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17814|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
17815|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
17816|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
17817|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17818|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17819|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
17820|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
17821|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
17822|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17823|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17824|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
17825|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
17826|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
17827|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
17828|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
17829|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
17830|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
17858|NCT02204449|B2|Baseline|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
17859|NCT02204449|B1|Baseline|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17860|NCT02204449|P2|Participant Flow|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
17861|NCT02204449|P1|Participant Flow|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17862|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
17863|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17864|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
17865|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17866|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
17867|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17868|NCT02204449|E2|Reported Event|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
18062|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18063|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
17869|NCT02204449|E1|Reported Event|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
17870|NCT02203916|B4|Baseline|Total|Total of all reporting groups
17871|NCT02203916|B3|Baseline|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17872|NCT02203916|B2|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17873|NCT02203916|B1|Baseline|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17874|NCT02203916|P3|Participant Flow|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17875|NCT02203916|P2|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17876|NCT02203916|P1|Participant Flow|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17877|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17878|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17879|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17880|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17881|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17882|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17883|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17884|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17885|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17886|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17887|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17888|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17889|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17890|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17891|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17892|NCT02203916|E3|Reported Event|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
17893|NCT02203916|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
17894|NCT02203916|E1|Reported Event|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
17895|NCT02203786|B5|Baseline|Total|Total of all reporting groups
17896|NCT02203786|B4|Baseline|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
17897|NCT02203786|B3|Baseline|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
17898|NCT02203786|B2|Baseline|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17899|NCT02203786|B1|Baseline|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17900|NCT02203786|P4|Participant Flow|Fluphenazine - Controls|"Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
17901|NCT02203786|P3|Participant Flow|Haloperidol - Controls|"Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
17963|NCT02203149|B1|Baseline|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17964|NCT02203149|P5|Participant Flow|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17902|NCT02203786|P2|Participant Flow|Fluphenazine - Pathological Gamblers|"Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
17903|NCT02203786|P1|Participant Flow|Haloperidol - Pathological Gamblers|"Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
17904|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
17905|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
17906|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17907|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17908|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
17909|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
17910|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17911|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17912|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
17913|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
17914|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17915|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17916|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
17917|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
17918|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17919|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17920|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
17921|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
17922|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17923|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17924|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
17925|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
17926|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17927|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
17928|NCT02203786|E4|Reported Event|Fluphenazine - Controls|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
17929|NCT02203786|E3|Reported Event|Haloperidol - Controls|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
17965|NCT02203149|P4|Participant Flow|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
18064|NCT02201940|E2|Reported Event|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
17930|NCT02203786|E2|Reported Event|Fluphenazine - Pathological Gamblers|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
17931|NCT02203786|E1|Reported Event|Haloperidol - Pathological Gamblers|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
17932|NCT02203747|B3|Baseline|Total|Total of all reporting groups
17933|NCT02203747|B2|Baseline|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
17934|NCT02203747|B1|Baseline|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
17935|NCT02203747|P2|Participant Flow|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
17936|NCT02203747|P1|Participant Flow|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
17937|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
17938|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
17939|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
17940|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
17941|NCT02203747|E2|Reported Event|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
17942|NCT02203747|E1|Reported Event|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
17943|NCT02203721|B3|Baseline|Total|Total of all reporting groups
17944|NCT02203721|B2|Baseline|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
17945|NCT02203721|B1|Baseline|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
17946|NCT02203721|P2|Participant Flow|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
17947|NCT02203721|P1|Participant Flow|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
17948|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
17949|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
17950|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
17951|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
17952|NCT02203721|E2|Reported Event|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
17953|NCT02203721|E1|Reported Event|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
17954|NCT02203162|B1|Baseline|Subjects|all subjects underwent cough challenge testing at baseline and after e-cig exposure
17955|NCT02203162|P1|Participant Flow|Electronic Cigarette Exposure|30 healthy subjects-adult nonsmokers
17956|NCT02203162|O1|Outcome|Electronic Cigarette Exposure|30 subjects-healthy adult nonsmokers
17957|NCT02203162|E1|Reported Event|Subjects|30 subjects-adult nonsmokers
17958|NCT02203149|B6|Baseline|Total|Total of all reporting groups
17959|NCT02203149|B5|Baseline|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17960|NCT02203149|B4|Baseline|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
17961|NCT02203149|B3|Baseline|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17962|NCT02203149|B2|Baseline|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
18267|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
17966|NCT02203149|P3|Participant Flow|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17967|NCT02203149|P2|Participant Flow|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17968|NCT02203149|P1|Participant Flow|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17969|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17970|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
17971|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17972|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17973|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
17974|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17975|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
17976|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.
17977|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
17978|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
17979|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
17980|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
17981|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17982|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17983|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17984|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17985|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
17986|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
17987|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
17988|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
17989|NCT02203149|O5|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17990|NCT02203149|O4|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
17991|NCT02203149|O3|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17992|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
18057|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18058|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
17993|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17994|NCT02203149|E6|Reported Event|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17995|NCT02203149|E5|Reported Event|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
17996|NCT02203149|E4|Reported Event|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
17997|NCT02203149|E3|Reported Event|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
17998|NCT02203149|E2|Reported Event|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
17999|NCT02203149|E1|Reported Event|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
18000|NCT02202538|B1|Baseline|All Subjects|All subjects enrolled in the study used the Indego
18001|NCT02202538|P1|Participant Flow|All Subjects|All subjects enrolled in the study used the Indego
18002|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18003|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18004|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18005|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18006|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18007|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18008|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18009|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
18010|NCT02202538|E1|Reported Event|All Subjects|All subjects enrolled in the study used the Indego
18011|NCT02202252|B3|Baseline|Total|Total of all reporting groups
18012|NCT02202252|B2|Baseline|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18013|NCT02202252|B1|Baseline|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18014|NCT02202252|P2|Participant Flow|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18015|NCT02202252|P1|Participant Flow|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18016|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18017|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18268|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18018|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18019|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18020|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18021|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
18022|NCT02202252|E2|Reported Event|Double Drain|Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
18023|NCT02202252|E1|Reported Event|Single Drain|Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
18024|NCT02202135|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
18025|NCT02202135|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
18026|NCT02202135|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
18027|NCT02202135|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
18028|NCT02201953|B3|Baseline|Total|Total of all reporting groups
18029|NCT02201953|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18030|NCT02201953|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18031|NCT02201953|P2|Participant Flow|SOF+RBV 24 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18032|NCT02201953|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
18033|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18034|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18035|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18036|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18037|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18038|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18039|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18040|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18041|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18042|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18043|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
18044|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18045|NCT02201953|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
18046|NCT02201953|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18047|NCT02201940|B3|Baseline|Total|Total of all reporting groups
18048|NCT02201940|B2|Baseline|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18049|NCT02201940|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18050|NCT02201940|P2|Participant Flow|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18051|NCT02201940|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
18052|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18053|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18054|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18055|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18056|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
18065|NCT02201940|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
18066|NCT02201901|B4|Baseline|Total|Total of all reporting groups
18067|NCT02201901|B3|Baseline|SOF/VEL 24 Weeks ((Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18068|NCT02201901|B2|Baseline|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18069|NCT02201901|B1|Baseline|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
18070|NCT02201901|P3|Participant Flow|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18071|NCT02201901|P2|Participant Flow|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18072|NCT02201901|P1|Participant Flow|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
18073|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18074|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18075|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18076|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18077|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18078|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18079|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18080|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18081|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18082|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18083|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18084|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18085|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18086|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18087|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18088|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18089|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18090|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18091|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18092|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18093|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18094|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18095|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18096|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18097|NCT02201901|E3|Reported Event|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
18098|NCT02201901|E2|Reported Event|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
18099|NCT02201901|E1|Reported Event|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
18100|NCT02201784|B3|Baseline|Total|Total of all reporting groups
18101|NCT02201784|B2|Baseline|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18102|NCT02201784|B1|Baseline|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18103|NCT02201784|P2|Participant Flow|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18104|NCT02201784|P1|Participant Flow|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18105|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18106|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18107|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18108|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18109|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18110|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18111|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18112|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18113|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18114|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18115|NCT02201784|E2|Reported Event|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
18116|NCT02201784|E1|Reported Event|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
18117|NCT02201524|B5|Baseline|Total|Total of all reporting groups
18118|NCT02201524|B4|Baseline|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18119|NCT02201524|B3|Baseline|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18120|NCT02201524|B2|Baseline|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18121|NCT02201524|B1|Baseline|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18122|NCT02201524|P4|Participant Flow|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18123|NCT02201524|P3|Participant Flow|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18124|NCT02201524|P2|Participant Flow|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18125|NCT02201524|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18126|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18127|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18128|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18129|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18130|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18131|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18132|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18133|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18134|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18135|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18136|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18137|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18138|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18139|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18140|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18141|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18142|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18143|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18144|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18145|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18146|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18147|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18148|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18149|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18150|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18151|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18152|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18153|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18154|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18155|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18156|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18157|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
30430|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
18158|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18159|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18160|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18161|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18162|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18163|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18164|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18165|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18166|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18167|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18168|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18169|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18170|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18171|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18172|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18173|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18174|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18175|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18176|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18177|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18178|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18179|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18180|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18181|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18182|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18183|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18184|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18185|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18186|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18187|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18188|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18189|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18190|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18191|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18192|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18193|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18194|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18195|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18196|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18197|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18198|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18199|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18200|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18201|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18202|NCT02201524|E4|Reported Event|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
18203|NCT02201524|E3|Reported Event|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
18269|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18204|NCT02201524|E2|Reported Event|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
18205|NCT02201524|E1|Reported Event|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
18206|NCT02201446|B3|Baseline|Total|Total of all reporting groups
18207|NCT02201446|B2|Baseline|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18208|NCT02201446|B1|Baseline|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18209|NCT02201446|P2|Participant Flow|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18210|NCT02201446|P1|Participant Flow|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18211|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18212|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18213|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18214|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18215|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18216|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18217|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18218|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18219|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18220|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18221|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18222|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18223|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18224|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18225|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18226|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18227|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18228|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18229|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18230|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18231|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18232|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18233|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18234|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18235|NCT02201446|E2|Reported Event|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
18236|NCT02201446|E1|Reported Event|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
18237|NCT02201420|B1|Baseline|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
18238|NCT02201420|P1|Participant Flow|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
18239|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
18240|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
18241|NCT02201420|E1|Reported Event|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
18242|NCT02201056|B8|Baseline|Total|Total of all reporting groups
18243|NCT02201056|B7|Baseline|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18244|NCT02201056|B6|Baseline|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18245|NCT02201056|B5|Baseline|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18246|NCT02201056|B4|Baseline|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18247|NCT02201056|B3|Baseline|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18248|NCT02201056|B2|Baseline|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18249|NCT02201056|B1|Baseline|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18250|NCT02201056|P7|Participant Flow|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18251|NCT02201056|P6|Participant Flow|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18252|NCT02201056|P5|Participant Flow|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18253|NCT02201056|P4|Participant Flow|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18254|NCT02201056|P3|Participant Flow|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18255|NCT02201056|P2|Participant Flow|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18256|NCT02201056|P1|Participant Flow|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18257|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18258|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18259|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18260|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18261|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18262|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18263|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18264|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18265|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18266|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18277|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18278|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18279|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18280|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18281|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18282|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18283|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18284|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18285|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18286|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18287|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18288|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18289|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18290|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18291|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18292|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18293|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18294|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18295|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18296|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18297|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18298|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18299|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18300|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18301|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18302|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18303|NCT02201056|E7|Reported Event|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
18304|NCT02201056|E6|Reported Event|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
18305|NCT02201056|E5|Reported Event|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
18306|NCT02201056|E4|Reported Event|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
18307|NCT02201056|E3|Reported Event|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
18308|NCT02201056|E2|Reported Event|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
18309|NCT02201056|E1|Reported Event|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
18310|NCT02200536|B4|Baseline|Total|Total of all reporting groups
18311|NCT02200536|B3|Baseline|Control 2|No intervention.
18312|NCT02200536|B2|Baseline|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
18313|NCT02200536|B1|Baseline|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
18314|NCT02200536|P3|Participant Flow|Control 2|No intervention.
18315|NCT02200536|P2|Participant Flow|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
18316|NCT02200536|P1|Participant Flow|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
18317|NCT02200536|O3|Outcome|Control 2|No intervention.
18318|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
18319|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
18320|NCT02200536|O3|Outcome|Control 2|No intervention.
18321|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
18322|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
18323|NCT02200536|E3|Reported Event|Control 2|No intervention.
18324|NCT02200536|E2|Reported Event|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
18325|NCT02200536|E1|Reported Event|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
18326|NCT02200458|B1|Baseline|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
18327|NCT02200458|P1|Participant Flow|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
18328|NCT02200458|O1|Outcome|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
18329|NCT02200458|E1|Reported Event|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
18330|NCT02200328|B3|Baseline|Total|Total of all reporting groups
18536|NCT02196675|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
18331|NCT02200328|B2|Baseline|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
18332|NCT02200328|B1|Baseline|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
18333|NCT02200328|P2|Participant Flow|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
18334|NCT02200328|P1|Participant Flow|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
18335|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
18336|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
18337|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
18338|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
18339|NCT02200328|E2|Reported Event|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
18340|NCT02200328|E1|Reported Event|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
18341|NCT02199717|B1|Baseline|Boys With Hemophilia|
18342|NCT02199717|P1|Participant Flow|Boys With Hemophilia|Use of accelerometer for 1 week
18343|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
18344|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
18345|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
18346|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
18347|NCT02199717|E1|Reported Event|Severe Hemophilia|
18348|NCT02199574|B1|Baseline|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
18349|NCT02199574|P1|Participant Flow|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
18350|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
18351|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
18352|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
18353|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
18354|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
18355|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: 133 mg EXPAREL in 10 mL."
18356|NCT02199574|E1|Reported Event|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
18357|NCT02198963|B1|Baseline|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
18358|NCT02198963|P1|Participant Flow|RUT058-60 vs Negative Control vs Positive Control|Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
18359|NCT02198963|O6|Outcome|Physiological Saline (0.9%), USP- Non-Abraded|0.02 mL of the Negative Control applied to non-abraded skin sites.
18360|NCT02198963|O5|Outcome|Sodium Lauryl Sulfate (0.1%)- Non-Abraded|0.02 mL of the Positive Control applied to non-abraded skin sites.
18361|NCT02198963|O4|Outcome|Hypochlorous Acid Solution 106 mg/L- Non-Abraded|0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
18362|NCT02198963|O3|Outcome|Physiological Saline (0.9%), USP-Abraded|0.02 mL of the Negative Control applied to abraded skin sites.
18363|NCT02198963|O2|Outcome|Sodium Lauryl Sulfate (0.1%) -Abraded|0.02 mL of the Positive Control applied to abraded skin sites.
18364|NCT02198963|O1|Outcome|Hypochlorous Acid Solution 106 mg/L-Abraded|0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
18365|NCT02198963|E1|Reported Event|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
18366|NCT02198430|B3|Baseline|Total|Total of all reporting groups
18367|NCT02198430|B2|Baseline|Control Group|Children without hemophilia
18368|NCT02198430|B1|Baseline|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18369|NCT02198430|P2|Participant Flow|Control Group|Children without hemophilia
18370|NCT02198430|P1|Participant Flow|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18371|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
18372|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18373|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
18374|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18375|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
18376|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18377|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
18378|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18379|NCT02198430|E2|Reported Event|Control Group|Children without hemophilia
18380|NCT02198430|E1|Reported Event|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
18381|NCT02198235|B4|Baseline|Total|Total of all reporting groups
18382|NCT02198235|B3|Baseline|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18383|NCT02198235|B2|Baseline|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18384|NCT02198235|B1|Baseline|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18385|NCT02198235|P3|Participant Flow|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18386|NCT02198235|P2|Participant Flow|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18387|NCT02198235|P1|Participant Flow|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18388|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18389|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18390|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18391|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18392|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18393|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18394|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18395|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18396|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18397|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18398|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18399|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18400|NCT02198235|E3|Reported Event|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18401|NCT02198235|E2|Reported Event|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
18402|NCT02198235|E1|Reported Event|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
18403|NCT02197806|B5|Baseline|Total|Total of all reporting groups
18404|NCT02197806|B4|Baseline|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
18405|NCT02197806|B3|Baseline|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18406|NCT02197806|B2|Baseline|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18407|NCT02197806|B1|Baseline|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18408|NCT02197806|P4|Participant Flow|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
18409|NCT02197806|P3|Participant Flow|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18410|NCT02197806|P2|Participant Flow|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18411|NCT02197806|P1|Participant Flow|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18412|NCT02197806|O4|Outcome|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
18413|NCT02197806|O3|Outcome|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18414|NCT02197806|O2|Outcome|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18415|NCT02197806|O1|Outcome|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
30431|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
18416|NCT02197806|E4|Reported Event|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
18417|NCT02197806|E3|Reported Event|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18418|NCT02197806|E2|Reported Event|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18419|NCT02197806|E1|Reported Event|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
18420|NCT02197273|B3|Baseline|Total|Total of all reporting groups
18421|NCT02197273|B2|Baseline|Liposomal Bupivacaine|"THA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18422|NCT02197273|B1|Baseline|Standard of Care Analgesia|"THA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18423|NCT02197273|P2|Participant Flow|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18424|NCT02197273|P1|Participant Flow|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18425|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18426|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18427|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18428|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18446|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18537|NCT02196675|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
18538|NCT02195713|B3|Baseline|Total|Total of all reporting groups
30432|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
18429|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18430|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18431|NCT02197273|E2|Reported Event|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
18432|NCT02197273|E1|Reported Event|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
18433|NCT02197247|B1|Baseline|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
18434|NCT02197247|P1|Participant Flow|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
18435|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18436|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18437|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18438|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18439|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18440|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18441|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18442|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18443|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18444|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18445|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18534|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
20500|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
18447|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18448|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18449|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18450|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18451|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18452|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18453|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18454|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18455|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18456|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18457|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18458|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18459|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18460|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18461|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18462|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18463|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18464|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18465|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18466|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18467|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18535|NCT02196675|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18468|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18469|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
18470|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18471|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18472|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18473|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
18474|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
18475|NCT02197247|E1|Reported Event|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
18476|NCT02197234|B1|Baseline|AZD9291 and Simvastatin|Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
18477|NCT02197234|P1|Participant Flow|AZD9291 and Simvastatin|Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
18478|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18479|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18480|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18481|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18482|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18483|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18484|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18485|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18486|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18487|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18488|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18489|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18490|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
18491|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
18492|NCT02197234|E4|Reported Event|Overall|Simvastatin 40mg on Days 1 and 31. Daily AZD9291 doses on Days 3-32
18493|NCT02197234|E3|Reported Event|Simvastatin + AZD9291|Single oral dose of simvastatin 40mg on Day 31 and single oral doses of AZD9291 on Day 31 and 32
18494|NCT02197234|E2|Reported Event|AZD9291|AZD9291 80mg daily dosing on Days 3-30.
18495|NCT02197234|E1|Reported Event|Simvastatin Alone|Simvastatin 40mg single oral dose on Day 1
18496|NCT02196766|B1|Baseline|Bioclean First Care EX / Aosept Clearcare / Comfil|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
18497|NCT02196766|P2|Participant Flow|Aosept Clearcare Combo First,Then Bioclean First Care EX Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
18498|NCT02196766|P1|Participant Flow|Bioclean First Care EX Combo, Then Aosept Clearcare Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
18499|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18500|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18501|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18502|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18503|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18504|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18505|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18506|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18507|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18508|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18509|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18510|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18511|NCT02196766|E2|Reported Event|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18512|NCT02196766|E1|Reported Event|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
18513|NCT02196675|B4|Baseline|Total|Total of all reporting groups
18514|NCT02196675|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
18515|NCT02196675|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
18516|NCT02196675|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
18517|NCT02196675|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
18518|NCT02196675|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
18519|NCT02196675|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
18520|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18521|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
18522|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
18523|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18524|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
18525|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
18526|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18527|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
18528|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
18529|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18530|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
18531|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
18532|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
18533|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
18539|NCT02195713|B2|Baseline|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
18540|NCT02195713|B1|Baseline|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
18541|NCT02195713|P2|Participant Flow|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
18542|NCT02195713|P1|Participant Flow|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
18543|NCT02195713|O2|Outcome|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
18544|NCT02195713|O1|Outcome|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
18545|NCT02195713|E2|Reported Event|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
18546|NCT02195713|E1|Reported Event|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
18547|NCT02195687|B3|Baseline|Total|Total of all reporting groups
18548|NCT02195687|B2|Baseline|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18549|NCT02195687|B1|Baseline|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18550|NCT02195687|P2|Participant Flow|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18551|NCT02195687|P1|Participant Flow|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18552|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18553|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18554|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18555|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18556|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18557|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18558|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18559|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18560|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18561|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18562|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18563|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18564|NCT02195687|E2|Reported Event|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
18565|NCT02195687|E1|Reported Event|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
18566|NCT02195583|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
18567|NCT02195583|P1|Participant Flow|Overall Participants|"Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.~Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base~Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base"
18568|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18569|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18661|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
30513|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
18570|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18571|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18572|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18573|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18574|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18575|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18576|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18577|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18578|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18579|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18580|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18581|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18617|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18662|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
30514|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
18582|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18583|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18584|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18585|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18586|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18587|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18588|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18589|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18590|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18591|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18592|NCT02195583|E6|Reported Event|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18593|NCT02195583|E5|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18618|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18663|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
34636|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
18594|NCT02195583|E4|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18595|NCT02195583|E3|Reported Event|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18596|NCT02195583|E2|Reported Event|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18597|NCT02195583|E1|Reported Event|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
18598|NCT02195414|B1|Baseline|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18599|NCT02195414|P1|Participant Flow|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18600|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18601|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18602|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18603|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18604|NCT02195414|E1|Reported Event|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
18605|NCT02194621|B4|Baseline|Total|Total of all reporting groups
18606|NCT02194621|B3|Baseline|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18607|NCT02194621|B2|Baseline|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18608|NCT02194621|B1|Baseline|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18609|NCT02194621|P3|Participant Flow|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18610|NCT02194621|P2|Participant Flow|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18611|NCT02194621|P1|Participant Flow|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18612|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18613|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18614|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18615|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18616|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18619|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18620|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18621|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18622|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18623|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18624|NCT02194621|E3|Reported Event|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
18625|NCT02194621|E2|Reported Event|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
18626|NCT02194621|E1|Reported Event|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
18627|NCT02193828|B5|Baseline|Total|Total of all reporting groups
18628|NCT02193828|B4|Baseline|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18629|NCT02193828|B3|Baseline|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18630|NCT02193828|B2|Baseline|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18631|NCT02193828|B1|Baseline|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18632|NCT02193828|P4|Participant Flow|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18633|NCT02193828|P3|Participant Flow|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18634|NCT02193828|P2|Participant Flow|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18635|NCT02193828|P1|Participant Flow|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18636|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18637|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18638|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18639|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18640|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18641|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18642|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18643|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18644|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18645|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18646|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18647|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18648|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18649|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18650|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18651|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18652|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18653|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18654|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18655|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18656|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18657|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18658|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18659|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18660|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
34637|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
18664|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18665|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18666|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18667|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18668|NCT02193828|E4|Reported Event|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
18669|NCT02193828|E3|Reported Event|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
18670|NCT02193828|E2|Reported Event|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
18671|NCT02193828|E1|Reported Event|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
18672|NCT02193815|B1|Baseline|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
18673|NCT02193815|P1|Participant Flow|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
18674|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
18675|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
18676|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
18677|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
18678|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
18679|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
18680|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
18681|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18682|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
18683|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
18684|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
18685|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
18686|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
18687|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18688|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
18689|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
18690|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
18691|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
18692|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
18693|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18694|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
18695|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
18696|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
18697|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
18698|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
18699|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18700|NCT02193815|O2|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
18701|NCT02193815|O1|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
18702|NCT02193815|O2|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
18703|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18704|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
18705|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
18706|NCT02193815|E1|Reported Event|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
18707|NCT02193178|B1|Baseline|Overall Baseline Characteristics|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
18708|NCT02193178|P1|Participant Flow|Overall Participants|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
18709|NCT02193178|O2|Outcome|2 Weeks|
18710|NCT02193178|O1|Outcome|Baseline|
18711|NCT02193178|O2|Outcome|2 Weeks|
18712|NCT02193178|O1|Outcome|Baseline|
18713|NCT02193178|O2|Outcome|2 Weeks|
18714|NCT02193178|O1|Outcome|Baseline|
18715|NCT02193178|O2|Outcome|2 Weeks|
18716|NCT02193178|O1|Outcome|Baseline|
18717|NCT02193178|O2|Outcome|2 Weeks|
18718|NCT02193178|O1|Outcome|Baseline|
18719|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18720|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18721|NCT02193178|O1|Outcome|Habitual Lenses|
18722|NCT02193178|O4|Outcome|Conjunctival Indentation (2 Weeks)|
18723|NCT02193178|O3|Outcome|Conjunctival Staining (2 Weeks)|
18724|NCT02193178|O2|Outcome|Conjunctival Indentation (Baseline)|
18725|NCT02193178|O1|Outcome|Conjunctival Staining (Baseline)|
18726|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
18727|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
18728|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
18729|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
18730|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
18731|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
18732|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18733|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18734|NCT02193178|O1|Outcome|Habitual Lenses|
18735|NCT02193178|O3|Outcome|2 Weeks|
18736|NCT02193178|O2|Outcome|Baseline|
18737|NCT02193178|O1|Outcome|Habitual Lenses|
18738|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18739|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18740|NCT02193178|O1|Outcome|Habitual Lenses|
18741|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18742|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18743|NCT02193178|O1|Outcome|Habitual Lenses|
18744|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18745|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18746|NCT02193178|O1|Outcome|Habitual Lenses|
18747|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18748|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18749|NCT02193178|O1|Outcome|Habitual Lenses|
18750|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
18751|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
18752|NCT02193178|O1|Outcome|Habitual Lenses|
18753|NCT02193178|E1|Reported Event|Comfilcon A Toric XR MTO|"Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.~comfilcon A Toric XR (MTO) contact lenses"
18754|NCT02193165|B4|Baseline|Total|Total of all reporting groups
18755|NCT02193165|B3|Baseline|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18756|NCT02193165|B2|Baseline|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18757|NCT02193165|B1|Baseline|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18758|NCT02193165|P3|Participant Flow|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18759|NCT02193165|P2|Participant Flow|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18760|NCT02193165|P1|Participant Flow|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18811|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18761|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18762|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18763|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18764|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18765|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18766|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18767|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18768|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18769|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18770|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18771|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18772|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18773|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18774|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18775|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18776|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18777|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18812|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18813|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18778|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18779|NCT02193165|E3|Reported Event|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
18780|NCT02193165|E2|Reported Event|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
18781|NCT02193165|E1|Reported Event|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
18782|NCT02193087|B5|Baseline|Total|Total of all reporting groups
18783|NCT02193087|B4|Baseline|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18784|NCT02193087|B3|Baseline|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18785|NCT02193087|B2|Baseline|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18786|NCT02193087|B1|Baseline|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18787|NCT02193087|P4|Participant Flow|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18788|NCT02193087|P3|Participant Flow|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18789|NCT02193087|P2|Participant Flow|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18790|NCT02193087|P1|Participant Flow|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18791|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18792|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18793|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18794|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18795|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18796|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18797|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18798|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18799|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18800|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18801|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18802|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18803|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18804|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18805|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18806|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18807|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18808|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18809|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18810|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18814|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18815|NCT02193087|O5|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18816|NCT02193087|O4|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18817|NCT02193087|O3|Outcome|Group A and Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
18818|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18819|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18820|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18821|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18822|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18823|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
18824|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18825|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18826|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18827|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
18828|NCT02193087|E4|Reported Event|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
18829|NCT02193087|E3|Reported Event|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
18830|NCT02193087|E2|Reported Event|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
18831|NCT02193087|E1|Reported Event|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
18832|NCT02192879|B4|Baseline|Total|Total of all reporting groups
18833|NCT02192879|B3|Baseline|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18834|NCT02192879|B2|Baseline|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18835|NCT02192879|B1|Baseline|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18836|NCT02192879|P3|Participant Flow|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18837|NCT02192879|P2|Participant Flow|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18838|NCT02192879|P1|Participant Flow|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
34638|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
18839|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18840|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18841|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18842|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18843|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18844|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18845|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18846|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18847|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18848|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18849|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18850|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18851|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18852|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18867|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18853|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18854|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18855|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18856|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18857|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18858|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18859|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18860|NCT02192879|E3|Reported Event|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
18861|NCT02192879|E2|Reported Event|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
18862|NCT02192879|E1|Reported Event|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
18863|NCT02192814|B1|Baseline|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18864|NCT02192814|P1|Participant Flow|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18865|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18866|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18891|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
18868|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18869|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18870|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18871|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18872|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18873|NCT02192814|E1|Reported Event|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
18874|NCT02191865|B4|Baseline|Total|Total of all reporting groups
18875|NCT02191865|B3|Baseline|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
18876|NCT02191865|B2|Baseline|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
18877|NCT02191865|B1|Baseline|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
18878|NCT02191865|P3|Participant Flow|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
18879|NCT02191865|P2|Participant Flow|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
18880|NCT02191865|P1|Participant Flow|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
18881|NCT02191865|O3|Outcome|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
18882|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
18883|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
18884|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
18885|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
18886|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
18887|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
18888|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
18889|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
18890|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
18892|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
18893|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
18894|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
18895|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
18896|NCT02191865|E3|Reported Event|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
18897|NCT02191865|E2|Reported Event|Child Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
18898|NCT02191865|E1|Reported Event|Child Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
18899|NCT02191046|B3|Baseline|Total|Total of all reporting groups
18900|NCT02191046|B2|Baseline|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
18901|NCT02191046|B1|Baseline|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
18902|NCT02191046|P2|Participant Flow|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
18903|NCT02191046|P1|Participant Flow|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
18904|NCT02191046|O2|Outcome|Squeezable Bottle|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
18905|NCT02191046|O1|Outcome|Syringe 20 ml|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect
18906|NCT02191046|E2|Reported Event|Squeezable Bottle|record adverse event at baseline and daily adverse events until 2 weeks after treatment
18907|NCT02191046|E1|Reported Event|Syringe 20 ml|record adverse event at baseline and daily adverse events until 2 weeks after treatment
18908|NCT02190591|B3|Baseline|Total|Total of all reporting groups
18909|NCT02190591|B2|Baseline|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18910|NCT02190591|B1|Baseline|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18911|NCT02190591|P2|Participant Flow|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18912|NCT02190591|P1|Participant Flow|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18913|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18914|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18915|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18916|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18917|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18918|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18919|NCT02190591|E2|Reported Event|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
18920|NCT02190591|E1|Reported Event|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
18921|NCT02189954|B3|Baseline|Total|Total of all reporting groups
18922|NCT02189954|B2|Baseline|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
18923|NCT02189954|B1|Baseline|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
18924|NCT02189954|P2|Participant Flow|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)"
18925|NCT02189954|P1|Participant Flow|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
19211|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
18926|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
18927|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
18928|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
18929|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
18930|NCT02189954|E2|Reported Event|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
18931|NCT02189954|E1|Reported Event|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
18932|NCT02189941|B1|Baseline|Healthy Volunteers|Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart
18933|NCT02189941|P3|Participant Flow|Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions"
18934|NCT02189941|P2|Participant Flow|DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions"
18935|NCT02189941|P1|Participant Flow|DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release (IR) tablets under fasting conditions"
18936|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18937|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18938|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18939|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18940|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18941|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18942|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18943|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18944|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18945|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18946|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18947|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18948|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18949|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18950|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18951|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18952|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18953|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18954|NCT02189941|E3|Reported Event|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
18955|NCT02189941|E2|Reported Event|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18956|NCT02189941|E1|Reported Event|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
18957|NCT02189915|B1|Baseline|Creatine Monohydrate|Creatine monohydrate
18958|NCT02189915|P1|Participant Flow|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
18959|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
18960|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
18961|NCT02189915|E1|Reported Event|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
18962|NCT02189863|B1|Baseline|Overall|Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
18963|NCT02189863|P2|Participant Flow|AOAMF, Then AOAMV|Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
18964|NCT02189863|P1|Participant Flow|AOAMV, Then AOAMF|Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2
18965|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
18966|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
18967|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
18968|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
18969|NCT02189863|E5|Reported Event|Habitual|Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
18970|NCT02189863|E4|Reported Event|Biofinity MF|Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment
18971|NCT02189863|E3|Reported Event|Lotra B SVD|Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment
18972|NCT02189863|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
18973|NCT02189863|E1|Reported Event|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
18974|NCT02189837|B5|Baseline|Total|Total of all reporting groups
18975|NCT02189837|B4|Baseline|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18976|NCT02189837|B3|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18977|NCT02189837|B2|Baseline|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18978|NCT02189837|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18979|NCT02189837|P4|Participant Flow|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18980|NCT02189837|P3|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18981|NCT02189837|P2|Participant Flow|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18982|NCT02189837|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18983|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18984|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18985|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18986|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18987|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
34639|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
18988|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18989|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18990|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18991|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18992|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18993|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18994|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18995|NCT02189837|E4|Reported Event|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18996|NCT02189837|E3|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18997|NCT02189837|E2|Reported Event|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
18998|NCT02189837|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
18999|NCT02189317|B3|Baseline|Total|Total of all reporting groups
19000|NCT02189317|B2|Baseline|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19001|NCT02189317|B1|Baseline|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19002|NCT02189317|P2|Participant Flow|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19003|NCT02189317|P1|Participant Flow|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19004|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19005|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19006|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19007|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19008|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19009|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19010|NCT02189317|E2|Reported Event|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19105|NCT02187809|E1|Reported Event|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19106|NCT02187029|B5|Baseline|Total|Total of all reporting groups
19011|NCT02189317|E1|Reported Event|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
19012|NCT02189252|B5|Baseline|Total|Total of all reporting groups
19013|NCT02189252|B4|Baseline|Treatment Sequence 4|Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
19014|NCT02189252|B3|Baseline|Treatment Sequence 3|Epanova 2 g per day:Lovaza 4 g per day
19015|NCT02189252|B2|Baseline|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
19016|NCT02189252|B1|Baseline|Treatment Sequence 1|Epanova 4 g per day:Lovaza 4 g per day
19017|NCT02189252|P4|Participant Flow|Treatment Sequence 4|Lovaza 4g per day:Epanova 2g per day:
19018|NCT02189252|P3|Participant Flow|Treatment Sequence 3|Epanova 2g per day:Lovaza 4g per day:
19019|NCT02189252|P2|Participant Flow|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
19020|NCT02189252|P1|Participant Flow|Treatment Sequence 1|Epanova 4g per day: Lovaza 4g per day
19021|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19022|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19023|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19024|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19025|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19026|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19027|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19028|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19029|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19030|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19031|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19032|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19033|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19034|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19035|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19036|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19037|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19038|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19039|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19040|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19041|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19042|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
19043|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
19044|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
19045|NCT02189252|E6|Reported Event|Lovaza 4 g (II)|Treatment period II
19046|NCT02189252|E5|Reported Event|Epanova 4 g (II)|Treatment period II
19047|NCT02189252|E4|Reported Event|Epanova 2 g (II)|Treatment period II
19048|NCT02189252|E3|Reported Event|Lovaza 4 g (I)|Treatment period I
19049|NCT02189252|E2|Reported Event|Epanova 4 g (I)|Treatment period I
19050|NCT02189252|E1|Reported Event|Epanova 2 g (I)|Treatment period I
19051|NCT02189161|B1|Baseline|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19052|NCT02189161|P1|Participant Flow|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19053|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19054|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19055|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19056|NCT02189161|E1|Reported Event|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
19057|NCT02189122|B3|Baseline|Total|Total of all reporting groups
19107|NCT02187029|B4|Baseline|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
37782|NCT01987219|B7|Baseline|Total|Total of all reporting groups
19058|NCT02189122|B2|Baseline|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19059|NCT02189122|B1|Baseline|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19060|NCT02189122|P2|Participant Flow|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg."
19061|NCT02189122|P1|Participant Flow|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg."
19062|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19063|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19064|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19065|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19066|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19067|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19068|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19069|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19108|NCT02187029|B3|Baseline|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19070|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19071|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19072|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19073|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19074|NCT02189122|E2|Reported Event|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
19075|NCT02189122|E1|Reported Event|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
19076|NCT02188849|B3|Baseline|Total|Total of all reporting groups
19077|NCT02188849|B2|Baseline|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19078|NCT02188849|B1|Baseline|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19079|NCT02188849|P2|Participant Flow|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19080|NCT02188849|P1|Participant Flow|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19081|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19082|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19109|NCT02187029|B2|Baseline|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19110|NCT02187029|B1|Baseline|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19083|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19084|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19085|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19086|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19087|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19088|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19089|NCT02188849|E2|Reported Event|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
19090|NCT02188849|E1|Reported Event|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
19091|NCT02188589|B1|Baseline|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
19092|NCT02188589|P1|Participant Flow|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
19093|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
19094|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
19095|NCT02188589|E1|Reported Event|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
19096|NCT02187809|B1|Baseline|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19097|NCT02187809|P1|Participant Flow|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19098|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19099|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19100|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19101|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19102|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19103|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19104|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
19210|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
37783|NCT01987219|B6|Baseline|Ipratropium; Placebo; Albuterol|
19111|NCT02187029|P4|Participant Flow|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19112|NCT02187029|P3|Participant Flow|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19113|NCT02187029|P2|Participant Flow|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19114|NCT02187029|P1|Participant Flow|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19115|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19116|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19117|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19118|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19119|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19120|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19121|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19122|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19123|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19124|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19125|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19126|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19127|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19128|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19129|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19130|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19131|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19132|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19133|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19134|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19135|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19136|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19137|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19138|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19139|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19140|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19141|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19142|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19143|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19144|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19145|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19146|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19147|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19148|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19149|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19150|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19151|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19152|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19153|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19154|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19155|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19156|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19157|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19158|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19159|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19160|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19161|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19162|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19163|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19164|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19165|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19166|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19167|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19168|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19169|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19170|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19171|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19172|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
37784|NCT01987219|B5|Baseline|Placebo; Albuterol; Ipratropium|
19173|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19174|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19175|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19176|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19177|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19178|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19179|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19180|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19181|NCT02187029|E4|Reported Event|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
19182|NCT02187029|E3|Reported Event|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
19183|NCT02187029|E2|Reported Event|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
19184|NCT02187029|E1|Reported Event|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
19185|NCT02187016|B5|Baseline|Total|Total of all reporting groups
19186|NCT02187016|B4|Baseline|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19187|NCT02187016|B3|Baseline|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19188|NCT02187016|B2|Baseline|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19189|NCT02187016|B1|Baseline|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19190|NCT02187016|P4|Participant Flow|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19191|NCT02187016|P3|Participant Flow|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19192|NCT02187016|P2|Participant Flow|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19193|NCT02187016|P1|Participant Flow|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19194|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19195|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19196|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19197|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19198|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19199|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19200|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19201|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19202|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19203|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19204|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19205|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19206|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19207|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19208|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19209|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
37785|NCT01987219|B4|Baseline|Placebo; Ipratropium; Albuterol|
19212|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19213|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19214|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19215|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19216|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19217|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19218|NCT02187016|E4|Reported Event|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
19219|NCT02187016|E3|Reported Event|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
19220|NCT02187016|E2|Reported Event|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19221|NCT02187016|E1|Reported Event|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
19222|NCT02186808|B1|Baseline|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
19223|NCT02186808|P1|Participant Flow|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
19224|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
19225|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
19226|NCT02186808|E1|Reported Event|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
19227|NCT02186587|B3|Baseline|Total|Total of all reporting groups
19228|NCT02186587|B2|Baseline|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.~Off-the-shelf total knee implant"
19229|NCT02186587|B1|Baseline|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
19230|NCT02186587|P2|Participant Flow|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
19231|NCT02186587|P1|Participant Flow|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
19232|NCT02186587|O1|Outcome|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
19233|NCT02186587|E2|Reported Event|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
19234|NCT02186587|E1|Reported Event|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
19235|NCT02185729|B1|Baseline|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
19236|NCT02185729|P1|Participant Flow|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
19237|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
19238|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
19239|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
19240|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
19241|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
19242|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
19243|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
19244|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
19245|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
19246|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
19247|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
19248|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
19249|NCT02185729|E1|Reported Event|Healthy Volunteer|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
19250|NCT02185534|B7|Baseline|Total|Total of all reporting groups
19870|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19251|NCT02185534|B6|Baseline|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
19252|NCT02185534|B5|Baseline|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
19253|NCT02185534|B4|Baseline|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
19254|NCT02185534|B3|Baseline|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
19255|NCT02185534|B2|Baseline|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
19256|NCT02185534|B1|Baseline|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
19257|NCT02185534|P6|Participant Flow|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
19258|NCT02185534|P5|Participant Flow|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
19259|NCT02185534|P4|Participant Flow|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
19260|NCT02185534|P3|Participant Flow|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
19261|NCT02185534|P2|Participant Flow|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
19262|NCT02185534|P1|Participant Flow|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
19263|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
19264|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
19265|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
19266|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
19267|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
19268|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
19269|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
19270|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
19271|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
19272|NCT02185534|E4|Reported Event|Total Number of Participants|total number of subjects exposed to any treatment
19273|NCT02185534|E3|Reported Event|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
19274|NCT02185534|E2|Reported Event|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
19275|NCT02185534|E1|Reported Event|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
19276|NCT02185339|B3|Baseline|Total|Total of all reporting groups
19277|NCT02185339|B2|Baseline|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19278|NCT02185339|B1|Baseline|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19279|NCT02185339|P2|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19280|NCT02185339|P1|Participant Flow|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19281|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19282|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19283|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19284|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19285|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19286|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19340|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19871|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19287|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19288|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19289|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19290|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19291|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19292|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19293|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19294|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19295|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19296|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19341|NCT02185105|O1|Outcome|Comfilcon A XR (Extended Range) Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19872|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19297|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19298|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19299|NCT02185339|E2|Reported Event|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19300|NCT02185339|E1|Reported Event|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
19301|NCT02185183|B1|Baseline|AlequelTM|"AlequelTM~Alequel: Alequel"
19302|NCT02185183|P1|Participant Flow|AlequelTM 30 ng Once a Day Orally|"AlequelTM 30 ng once a day orally~Alequel: Alequel"
19303|NCT02185183|O1|Outcome|AlequelTM|"AlequelTM~Alequel: Alequel"
19304|NCT02185183|E1|Reported Event|AlequelTM|"AlequelTM~Alequel: Alequel"
19305|NCT02185105|B1|Baseline|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19306|NCT02185105|P1|Participant Flow|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19307|NCT02185105|O2|Outcome|Comfilcon A Toric|
19308|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19309|NCT02185105|O2|Outcome|Comfilcon A Toric|
19310|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19311|NCT02185105|O2|Outcome|Comfilcon A Toric|
19312|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19313|NCT02185105|O2|Outcome|Comfilcon A Toric|
19314|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19315|NCT02185105|O2|Outcome|Comfilcon A Toric|
19316|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19317|NCT02185105|O2|Outcome|Comfilcon A Toric|
19318|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19319|NCT02185105|O2|Outcome|Comfilcon A Toric|
19320|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19321|NCT02185105|O2|Outcome|Comfilcon A Toric|
19322|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19323|NCT02185105|O2|Outcome|Comfilcon A Toric|
19324|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19325|NCT02185105|O2|Outcome|Comfilcon A Toric|
19326|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19327|NCT02185105|O2|Outcome|Comfilcon A Toric|
19328|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19329|NCT02185105|O3|Outcome|No Preference|
19330|NCT02185105|O2|Outcome|Comfilcon A Toric|
19331|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19332|NCT02185105|O2|Outcome|Comfilcon A Toric|
19333|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
19334|NCT02185105|O2|Outcome|Comfilcon A Toric|
19335|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
19336|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19337|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19338|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19339|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19342|NCT02185105|E2|Reported Event|Comfilcon A|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19343|NCT02185105|E1|Reported Event|Comfilcon A MTO|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
19344|NCT02184494|B4|Baseline|Total|Total of all reporting groups
19345|NCT02184494|B3|Baseline|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19346|NCT02184494|B2|Baseline|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19347|NCT02184494|B1|Baseline|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19348|NCT02184494|P3|Participant Flow|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19349|NCT02184494|P2|Participant Flow|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19350|NCT02184494|P1|Participant Flow|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19351|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19352|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19353|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19354|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19355|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19391|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19356|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19357|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19358|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19359|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19360|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19361|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19362|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19363|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19364|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19365|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19366|NCT02184494|E3|Reported Event|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19367|NCT02184494|E2|Reported Event|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19392|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
19393|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
19368|NCT02184494|E1|Reported Event|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
19369|NCT02183675|B7|Baseline|Total|Total of all reporting groups
19370|NCT02183675|B6|Baseline|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
19371|NCT02183675|B5|Baseline|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
19372|NCT02183675|B4|Baseline|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
19373|NCT02183675|B3|Baseline|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
19374|NCT02183675|B2|Baseline|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
19375|NCT02183675|B1|Baseline|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
19376|NCT02183675|P6|Participant Flow|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
19377|NCT02183675|P5|Participant Flow|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
19378|NCT02183675|P4|Participant Flow|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
19379|NCT02183675|P3|Participant Flow|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
19380|NCT02183675|P2|Participant Flow|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
19381|NCT02183675|P1|Participant Flow|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
19382|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
19383|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19384|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
19385|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19386|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
19387|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19388|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
19389|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19390|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
37786|NCT01987219|B3|Baseline|Albuterol; Ipratropium; Placebo|
19394|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19395|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
19396|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
19397|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19398|NCT02183675|E4|Reported Event|All Patients|"All participants in the study. Participants received three treatments in a randomised order~T80-A5-H12.5~T80-A5~T80-H12.5"
19399|NCT02183675|E3|Reported Event|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
19400|NCT02183675|E2|Reported Event|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
19401|NCT02183675|E1|Reported Event|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
19402|NCT02181530|B1|Baseline|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19403|NCT02181530|P1|Participant Flow|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19404|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19405|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19406|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19407|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19408|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19409|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19410|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19411|NCT02181530|E1|Reported Event|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
19412|NCT02181517|B4|Baseline|Total|Total of all reporting groups
19413|NCT02181517|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19414|NCT02181517|B2|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19415|NCT02181517|B1|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19416|NCT02181517|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19417|NCT02181517|P2|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19418|NCT02181517|P1|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19419|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19420|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19421|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19422|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19423|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19424|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19425|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19426|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19427|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19428|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19429|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19430|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19431|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19432|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19433|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19434|NCT02181517|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
19435|NCT02181517|E2|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19436|NCT02181517|E1|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
19437|NCT02181140|B1|Baseline|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
19438|NCT02181140|P1|Participant Flow|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
19439|NCT02181140|O1|Outcome|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
19440|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided Pro core FNA: Histology samples (not cytology)
19441|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
19442|NCT02181140|E1|Reported Event|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
19443|NCT02181127|B1|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
19444|NCT02181127|P1|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
19445|NCT02181127|O2|Outcome|Placebo|Glucagon-only Bionic Pancreas delivered placebo during 7 of the 14 days. The order of the placebo days was randomized in blocks of 2, with no more than 2 days in a row of placebo.
19446|NCT02181127|O1|Outcome|Glucagon-only Bionic Pancreas|Glucagon-only Bionic Pancreas delivered glucagon during 7 of the 14 days. The order of the glucagon days was randomized in blocks of 2, with no more than 2 days in a row of glucagon.
19447|NCT02181127|E1|Reported Event|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
19448|NCT02180893|B3|Baseline|Total|Total of all reporting groups
19449|NCT02180893|B2|Baseline|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19450|NCT02180893|B1|Baseline|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
19451|NCT02180893|P2|Participant Flow|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19452|NCT02180893|P1|Participant Flow|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
19453|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19454|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
19455|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19456|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
19457|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19458|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
19459|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
19460|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
19461|NCT02180893|E2|Reported Event|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
20910|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
19462|NCT02180893|E1|Reported Event|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
19463|NCT02180828|B3|Baseline|Total|Total of all reporting groups
19464|NCT02180828|B2|Baseline|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19465|NCT02180828|B1|Baseline|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19466|NCT02180828|P2|Participant Flow|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19467|NCT02180828|P1|Participant Flow|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19468|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19469|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19470|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19471|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19472|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19473|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19474|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19475|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19476|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19477|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19478|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19479|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19480|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19481|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19482|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19483|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19484|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19485|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19486|NCT02180828|E2|Reported Event|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
19487|NCT02180828|E1|Reported Event|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
19488|NCT02180646|B3|Baseline|Total|Total of all reporting groups
19489|NCT02180646|B2|Baseline|High Protein Then High Carb Breakfast|A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
19490|NCT02180646|B1|Baseline|High Carb Then High Protein Breakfast|A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
19491|NCT02180646|P2|Participant Flow|High Protein Then High Carb Breakfast|A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
19492|NCT02180646|P1|Participant Flow|High Carb Then High Protein Breakfast|A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
19493|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19494|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19495|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19496|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19497|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
20911|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
19498|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19499|NCT02180646|E2|Reported Event|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19500|NCT02180646|E1|Reported Event|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
19501|NCT02180230|B1|Baseline|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
19502|NCT02180230|P1|Participant Flow|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
19503|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
19504|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
19505|NCT02180230|E1|Reported Event|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
19506|NCT02180061|B3|Baseline|Total|Total of all reporting groups
19507|NCT02180061|B2|Baseline|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19508|NCT02180061|B1|Baseline|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19509|NCT02180061|P2|Participant Flow|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19510|NCT02180061|P1|Participant Flow|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
19511|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19512|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19513|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19514|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19515|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19516|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19517|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19518|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19519|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19520|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19521|NCT02180061|E2|Reported Event|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19522|NCT02180061|E1|Reported Event|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
19523|NCT02179424|B5|Baseline|Total|Total of all reporting groups
19524|NCT02179424|B4|Baseline|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19525|NCT02179424|B3|Baseline|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19526|NCT02179424|B2|Baseline|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19527|NCT02179424|B1|Baseline|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19528|NCT02179424|P4|Participant Flow|Phone Counseling + Booklet + SMS|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19529|NCT02179424|P3|Participant Flow|Phone Counseling + Health Talk + Booklet + SMS|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19530|NCT02179424|P2|Participant Flow|Face-to-face Counseling + Booklet + SMS|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19531|NCT02179424|P1|Participant Flow|Health Talk + Workshop + Booklet + SMS|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19532|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19533|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19534|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19676|NCT02176525|B6|Baseline|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19535|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19536|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19537|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19538|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19539|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19540|NCT02179424|O1|Outcome|Employers' KAP|Employers' knowledge on smoking and quitting
19541|NCT02179424|E4|Reported Event|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19542|NCT02179424|E3|Reported Event|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19543|NCT02179424|E2|Reported Event|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19544|NCT02179424|E1|Reported Event|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
19545|NCT02179398|B3|Baseline|Total|Total of all reporting groups
19546|NCT02179398|B2|Baseline|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19547|NCT02179398|B1|Baseline|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19548|NCT02179398|P2|Participant Flow|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19549|NCT02179398|P1|Participant Flow|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19550|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
19551|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
19552|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
19553|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
19554|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
19555|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
19556|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
19557|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
19558|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19559|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19560|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19561|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19562|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.~(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19563|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19564|NCT02179398|E2|Reported Event|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
19620|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19565|NCT02179398|E1|Reported Event|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
19566|NCT02178995|B3|Baseline|Total|Total of all reporting groups
19567|NCT02178995|B2|Baseline|Healthy Controls|Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
19568|NCT02178995|B1|Baseline|Participants With Epilepsy|"Participants received three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time. Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed."
19569|NCT02178995|P9|Participant Flow|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
19570|NCT02178995|P8|Participant Flow|20mg, 10mg, Then Placebo - Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19571|NCT02178995|P7|Participant Flow|20mg, Placebo, Then 10mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19572|NCT02178995|P6|Participant Flow|Placebo, 10mg, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19573|NCT02178995|P5|Participant Flow|Placebo, 20mg, Then 10mg (Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19574|NCT02178995|P4|Participant Flow|10mg, Placebo, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19575|NCT02178995|P3|Participant Flow|10mg, 20mg, Then Placebo (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19576|NCT02178995|P2|Participant Flow|Healthy Controls|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19677|NCT02176525|B5|Baseline|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
20912|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
19577|NCT02178995|P1|Participant Flow|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
19578|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19579|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19580|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19581|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19582|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19583|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19584|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19585|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19586|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19587|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19588|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19589|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19590|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19591|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19592|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
19637|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
37787|NCT01987219|B2|Baseline|Albuterol; Placebo; Ipratropium|
19593|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19594|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19595|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19596|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19597|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19598|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the SSC is specific to medication side effects, healthy controls did not complete the questionnaire.
19599|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19600|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the questionnaire is specific to epilepsy populations, and the side-effects to AEDs, healthy controls did not complete the QOLIE-89.
19601|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19602|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19603|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19604|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19605|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19606|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
19673|NCT02176525|B9|Baseline|Total|Total of all reporting groups
19607|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19608|NCT02178995|O2|Outcome|Participants With Epilepsy (Double-blind Portion)|
19609|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19610|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19611|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19612|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19613|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
19614|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19615|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|
19616|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19617|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19618|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19619|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19674|NCT02176525|B8|Baseline|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19621|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19622|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19623|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19624|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19625|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19626|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
19627|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
19628|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
19629|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19630|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19631|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19632|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19633|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19634|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19635|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19636|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
19675|NCT02176525|B7|Baseline|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
20913|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
19638|NCT02178995|E2|Reported Event|Healthy Controls|Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only.
19639|NCT02178995|E1|Reported Event|Participants With Epilepsy|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
19640|NCT02178540|B1|Baseline|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
19641|NCT02178540|P1|Participant Flow|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
19642|NCT02178540|O1|Outcome|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
19643|NCT02178540|E4|Reported Event|Open Label (>=18) Years Old|
19644|NCT02178540|E3|Reported Event|Open Label (11-17)Years Old|
19645|NCT02178540|E2|Reported Event|Total - All Participants|
19646|NCT02178540|E1|Reported Event|Open Label (6-10) Years Old|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
19647|NCT02178059|B1|Baseline|Randomized Subjects|All randomized subjects
19648|NCT02178059|P2|Participant Flow|M2 First, Then M3|Sequence 2: M2 first, then M3
19649|NCT02178059|P1|Participant Flow|M3 First, Then M2|Sequence 1: M3 first then M2
19650|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19651|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19652|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19653|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19654|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19655|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19656|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19657|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19658|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19659|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19660|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19661|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
19662|NCT02178059|E2|Reported Event|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations as a single dose
19663|NCT02178059|E1|Reported Event|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations as a single dose
19664|NCT02177201|B3|Baseline|Total|Total of all reporting groups
19665|NCT02177201|B2|Baseline|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
19666|NCT02177201|B1|Baseline|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
19667|NCT02177201|P2|Participant Flow|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
19668|NCT02177201|P1|Participant Flow|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
19669|NCT02177201|O2|Outcome|20 ml/kg/h 0.9% Saline Solution|"Group 2, intravenous 20 ml/kg/h 0.9% saline solution~0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively"
19670|NCT02177201|O1|Outcome|10 ml/kg/h 0.9 %Saline Solution|"Group 1, intravenous 10 ml/kg/h 0.9% saline solution ,~0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;"
19671|NCT02177201|E2|Reported Event|Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution|Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
19672|NCT02177201|E1|Reported Event|Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution|Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
19678|NCT02176525|B4|Baseline|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19679|NCT02176525|B3|Baseline|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19680|NCT02176525|B2|Baseline|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19681|NCT02176525|B1|Baseline|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19682|NCT02176525|P8|Participant Flow|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19683|NCT02176525|P7|Participant Flow|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19684|NCT02176525|P6|Participant Flow|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19685|NCT02176525|P5|Participant Flow|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19686|NCT02176525|P4|Participant Flow|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19687|NCT02176525|P3|Participant Flow|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19688|NCT02176525|P2|Participant Flow|DBV 100mg Fibrosis|Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19689|NCT02176525|P1|Participant Flow|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19690|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19691|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19692|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19693|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
19694|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19695|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19696|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19697|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19698|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19699|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19700|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
19701|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19702|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19703|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19704|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19705|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19706|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19707|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19708|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19709|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19710|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19711|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19712|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19713|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19714|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19715|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19716|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19717|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19718|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19719|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19720|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19721|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19722|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19723|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19724|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19725|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19726|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19727|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19728|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19729|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19730|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19731|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19732|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19733|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19734|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19735|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19736|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19737|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19738|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19739|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19740|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19741|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19742|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19743|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19744|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19745|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19746|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19747|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19748|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19749|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19750|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19751|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19752|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19753|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19869|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19754|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19755|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19756|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19757|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19758|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19759|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19760|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19761|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19762|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19763|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19764|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19765|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19766|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19767|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19768|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19769|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19770|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19771|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19772|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19773|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19774|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19775|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19776|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19777|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19778|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19779|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19780|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19781|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19782|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19783|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19784|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19785|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19786|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19787|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19788|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19789|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19790|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19791|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
37788|NCT01987219|B1|Baseline|Ipratropium; Alubterol; Placebo|
19792|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19793|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19794|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19795|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19796|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19797|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19798|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19799|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19800|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19801|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19802|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19803|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19804|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19805|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19806|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19807|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19808|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19809|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19810|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19811|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19812|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19813|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19814|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19815|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19816|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19817|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19818|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19819|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19820|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19821|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19822|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19823|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19824|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19825|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19826|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19827|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19828|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19829|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
43547|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
19830|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19831|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19832|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19833|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19834|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19835|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19836|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19837|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19838|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19839|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19840|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19841|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19842|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19843|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19844|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19845|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19846|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19847|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19848|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19849|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19850|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19851|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19852|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19853|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19854|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19855|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19856|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19857|NCT02176525|E8|Reported Event|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19858|NCT02176525|E7|Reported Event|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19859|NCT02176525|E6|Reported Event|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19860|NCT02176525|E5|Reported Event|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
19861|NCT02176525|E4|Reported Event|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19862|NCT02176525|E3|Reported Event|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19863|NCT02176525|E2|Reported Event|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19864|NCT02176525|E1|Reported Event|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
19865|NCT02176421|B1|Baseline|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19866|NCT02176421|P1|Participant Flow|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19867|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19868|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
45494|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
19873|NCT02176421|E1|Reported Event|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
19874|NCT02176356|B1|Baseline|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19875|NCT02176356|P1|Participant Flow|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19876|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19877|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19878|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19879|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19880|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19881|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19882|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19883|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19884|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19885|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19886|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19887|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
45495|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
19888|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19889|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19890|NCT02176356|E1|Reported Event|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
19891|NCT02175212|B3|Baseline|Total|Total of all reporting groups
19892|NCT02175212|B2|Baseline|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19893|NCT02175212|B1|Baseline|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19894|NCT02175212|P2|Participant Flow|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19895|NCT02175212|P1|Participant Flow|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19896|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19897|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19898|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19899|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19900|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19901|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19931|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20914|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
19902|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19903|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19904|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19905|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19906|NCT02175212|E2|Reported Event|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19907|NCT02175212|E1|Reported Event|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
19908|NCT02175199|B3|Baseline|Total|Total of all reporting groups
19909|NCT02175199|B2|Baseline|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
19910|NCT02175199|B1|Baseline|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
19911|NCT02175199|P2|Participant Flow|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
19912|NCT02175199|P1|Participant Flow|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
19913|NCT02175199|O2|Outcome|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
19914|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
19915|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
19916|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
19917|NCT02175199|E3|Reported Event|FreshLook COLORBLENDS|Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
19918|NCT02175199|E2|Reported Event|AIR OPTIX COLORS|Includes all eyes exposed to AIR OPTIX® COLORS contact lenses
19919|NCT02175199|E1|Reported Event|Pre-treatment|Includes all subjects prior to the exposure to the investigational or control products
19920|NCT02175121|B6|Baseline|Total|Total of all reporting groups
19921|NCT02175121|B5|Baseline|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19922|NCT02175121|B4|Baseline|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19923|NCT02175121|B3|Baseline|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19924|NCT02175121|B2|Baseline|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19925|NCT02175121|B1|Baseline|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19926|NCT02175121|P5|Participant Flow|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19927|NCT02175121|P4|Participant Flow|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19928|NCT02175121|P3|Participant Flow|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19929|NCT02175121|P2|Participant Flow|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19930|NCT02175121|P1|Participant Flow|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19932|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19933|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19934|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19935|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19936|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19937|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19938|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19939|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19940|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19941|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19942|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19943|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19944|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19945|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19946|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19947|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19948|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19949|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19950|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19951|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19952|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19953|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19954|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19955|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19956|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19957|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19958|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19959|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19960|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19961|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19962|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19963|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19964|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19965|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19966|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19967|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19968|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19969|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19970|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19971|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19972|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20915|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
19973|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19974|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19975|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19976|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19977|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19978|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19979|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19980|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19981|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19982|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19983|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19984|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19985|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19986|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19987|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19988|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19989|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19990|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19991|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19992|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19993|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19994|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19995|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
19996|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
19997|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
19998|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
19999|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20000|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20001|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20002|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20003|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20004|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20005|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20006|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20007|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20008|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20009|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20010|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20011|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20012|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20146|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20013|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20014|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20015|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20016|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20017|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20018|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20019|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20020|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20021|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20022|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20023|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20024|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20025|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20026|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20027|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20028|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20029|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20030|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20031|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20032|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20033|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20034|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20035|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20036|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20037|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20038|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20039|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20040|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20041|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20042|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20043|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20044|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20045|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20046|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20047|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20048|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20049|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20050|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20051|NCT02175121|E5|Reported Event|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
20052|NCT02175121|E4|Reported Event|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20153|NCT02171234|B4|Baseline|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
20053|NCT02175121|E3|Reported Event|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
20054|NCT02175121|E2|Reported Event|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
20055|NCT02175121|E1|Reported Event|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
20056|NCT02173769|B1|Baseline|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20057|NCT02173769|P1|Participant Flow|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20058|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20059|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20060|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20061|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20062|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20063|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20064|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
20065|NCT02173769|E2|Reported Event|Spiriva 18 mcg + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
20066|NCT02173769|E1|Reported Event|Spiriva Respimat + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
20067|NCT02173054|B4|Baseline|Total|Total of all reporting groups
20068|NCT02173054|B3|Baseline|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20069|NCT02173054|B2|Baseline|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20070|NCT02173054|B1|Baseline|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20071|NCT02173054|P3|Participant Flow|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20072|NCT02173054|P2|Participant Flow|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20073|NCT02173054|P1|Participant Flow|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20074|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20075|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20076|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20077|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20147|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20078|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20079|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20080|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20081|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20082|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20083|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20084|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20085|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20086|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20087|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20088|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20089|NCT02173054|E3|Reported Event|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20090|NCT02173054|E2|Reported Event|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20091|NCT02173054|E1|Reported Event|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
20092|NCT02172755|B3|Baseline|Total|Total of all reporting groups
20093|NCT02172755|B2|Baseline|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20094|NCT02172755|B1|Baseline|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20095|NCT02172755|P2|Participant Flow|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20148|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20149|NCT02171247|E2|Reported Event|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20096|NCT02172755|P1|Participant Flow|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20097|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20098|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20099|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20100|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20101|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20102|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20103|NCT02172755|E2|Reported Event|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20104|NCT02172755|E1|Reported Event|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
20105|NCT02172742|B3|Baseline|Total|Total of all reporting groups
20106|NCT02172742|B2|Baseline|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
20107|NCT02172742|B1|Baseline|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
20108|NCT02172742|P2|Participant Flow|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
20109|NCT02172742|P1|Participant Flow|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
20110|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
20111|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
20112|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
20113|NCT02172742|E2|Reported Event|Placebo+Digoxin|Placebo + Digoxin
20114|NCT02172742|E1|Reported Event|BIA 2-093+Digoxin|BIA 2-093 + Digoxin
20115|NCT02172625|B3|Baseline|Total|Total of all reporting groups
20116|NCT02172625|B2|Baseline|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
20150|NCT02171247|E1|Reported Event|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20151|NCT02171234|B6|Baseline|Total|Total of all reporting groups
20152|NCT02171234|B5|Baseline|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
20117|NCT02172625|B1|Baseline|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
20118|NCT02172625|P2|Participant Flow|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
20119|NCT02172625|P1|Participant Flow|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
20120|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
20121|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20122|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
20123|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20124|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
20125|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20126|NCT02172625|O2|Outcome|Protandim Group|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
20127|NCT02172625|O1|Outcome|Placebo Group|"Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
20128|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
20129|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20130|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
20131|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20132|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
20133|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20134|NCT02172625|E2|Reported Event|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
20135|NCT02172625|E1|Reported Event|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
20136|NCT02171247|B3|Baseline|Total|Total of all reporting groups
20137|NCT02171247|B2|Baseline|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20138|NCT02171247|B1|Baseline|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20139|NCT02171247|P2|Participant Flow|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20140|NCT02171247|P1|Participant Flow|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20141|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20142|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20143|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20144|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
20145|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
20154|NCT02171234|B3|Baseline|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
20155|NCT02171234|B2|Baseline|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
20156|NCT02171234|B1|Baseline|Placebo|PLC, Placebo
20157|NCT02171234|P5|Participant Flow|Group 4 - 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 1200mg
20158|NCT02171234|P4|Participant Flow|Group 3 - 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 800mg
20159|NCT02171234|P3|Participant Flow|Group 2 - 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 400mg
20160|NCT02171234|P2|Participant Flow|Group 1 - 200 mg b.i.d.|BIA 2-093 200mg (twice daily)
20161|NCT02171234|P1|Participant Flow|Placebo|PLC, Placebo
20162|NCT02171234|O5|Outcome|Placebo|PLC, Placebo
20163|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
20164|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
20165|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
20166|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
20167|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
20168|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
20169|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
20170|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
20171|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
20172|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
20173|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
20174|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
20175|NCT02171234|E5|Reported Event|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
20176|NCT02171234|E4|Reported Event|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
20177|NCT02171234|E3|Reported Event|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
20178|NCT02171234|E2|Reported Event|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
20179|NCT02171234|E1|Reported Event|Placebo|PLC, Placebo
20180|NCT02171195|B10|Baseline|Total|Total of all reporting groups
20181|NCT02171195|B9|Baseline|Group 8 1200 mg|BIA 2-093 1200mg or placebo
20182|NCT02171195|B8|Baseline|Group 7 900 mg|BIA 2-093 900mg or placebo
20183|NCT02171195|B7|Baseline|Group 6 600 mg|BIA 2-093 600mg or placebo
20184|NCT02171195|B6|Baseline|Group 5 400 mg|BIA 2-093 or 400mg or placebo
20185|NCT02171195|B5|Baseline|Group 4 200 mg|BIA 2-093 200mg or placebo
20186|NCT02171195|B4|Baseline|Group 3 100 mg|BIA 2-093 100mg or placebo
20187|NCT02171195|B3|Baseline|Group 2 50 mg|BIA 2-093 50mg or placebo
20188|NCT02171195|B2|Baseline|Group 1 20 mg|BIA 2-093 20mg or placebo.
20189|NCT02171195|B1|Baseline|Placebo|Placebo, PLC
20190|NCT02171195|P9|Participant Flow|Group 8 1200 mg|BIA 2-093 1200mg or placebo
20191|NCT02171195|P8|Participant Flow|Group 7 900 mg|BIA 2-093 900mg or placebo
20192|NCT02171195|P7|Participant Flow|Group 6 600 mg|BIA 2-093 600mg or placebo
20193|NCT02171195|P6|Participant Flow|Group 5 400 mg|BIA 2-093 or 400mg or placebo
20194|NCT02171195|P5|Participant Flow|Group 4 200 mg|BIA 2-093 200mg or placebo
20195|NCT02171195|P4|Participant Flow|Group 3 100 mg|BIA 2-093 100mg or placebo
20196|NCT02171195|P3|Participant Flow|Group 2 50 mg|BIA 2-093 50mg or placebo
20197|NCT02171195|P2|Participant Flow|Group 1 20 mg|BIA 2-093 20mg or placebo.
20198|NCT02171195|P1|Participant Flow|Placebo|Placebo, PLC
20199|NCT02171195|O9|Outcome|Group 8 1200 mg|BIA 2-093 1200mg or placebo
20200|NCT02171195|O8|Outcome|Group 7 900 mg|BIA 2-093 900mg or placebo
20201|NCT02171195|O7|Outcome|Group 6 600 mg|BIA 2-093 600mg or placebo
20202|NCT02171195|O6|Outcome|Group 5 400 mg|BIA 2-093 or 400mg or placebo
20203|NCT02171195|O5|Outcome|Group 4 200 mg|BIA 2-093 200mg or placebo
20204|NCT02171195|O4|Outcome|Group 3 100 mg|BIA 2-093 100mg or placebo
20205|NCT02171195|O3|Outcome|Group 2 50 mg|BIA 2-093 50mg or placebo
20206|NCT02171195|O2|Outcome|Group 1 20 mg|BIA 2-093 20mg or placebo.
20207|NCT02171195|O1|Outcome|Placebo|Placebo, PLC
20208|NCT02171195|E9|Reported Event|Group 8 1200 mg|BIA 2-093 1200mg or placebo
20209|NCT02171195|E8|Reported Event|Group 7 900 mg|BIA 2-093 900mg or placebo
20210|NCT02171195|E7|Reported Event|Group 6 600 mg|BIA 2-093 600mg or placebo
20211|NCT02171195|E6|Reported Event|Group 5 400 mg|BIA 2-093 or 400mg or placebo
20212|NCT02171195|E5|Reported Event|Group 4 200 mg|BIA 2-093 200mg or placebo
20213|NCT02171195|E4|Reported Event|Group 3 100 mg|BIA 2-093 100mg or placebo
20214|NCT02171195|E3|Reported Event|Group 2 50 mg|BIA 2-093 50mg or placebo
20215|NCT02171195|E2|Reported Event|Group 1 20 mg|BIA 2-093 20mg or placebo.
20216|NCT02171195|E1|Reported Event|Placebo|Placebo, PLC
20217|NCT02170688|B6|Baseline|Total|Total of all reporting groups
20229|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20218|NCT02170688|B5|Baseline|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20219|NCT02170688|B4|Baseline|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20220|NCT02170688|B3|Baseline|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20221|NCT02170688|B2|Baseline|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20222|NCT02170688|B1|Baseline|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
20223|NCT02170688|P5|Participant Flow|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20224|NCT02170688|P4|Participant Flow|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20225|NCT02170688|P3|Participant Flow|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20226|NCT02170688|P2|Participant Flow|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20227|NCT02170688|P1|Participant Flow|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
20228|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20242|NCT02170688|E1|Reported Event|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
20230|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20231|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20232|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
20233|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20234|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20235|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20236|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20237|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
20238|NCT02170688|E5|Reported Event|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20239|NCT02170688|E4|Reported Event|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20240|NCT02170688|E3|Reported Event|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20241|NCT02170688|E2|Reported Event|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
20243|NCT02170662|B3|Baseline|Total|Total of all reporting groups
20244|NCT02170662|B2|Baseline|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20245|NCT02170662|B1|Baseline|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20246|NCT02170662|P2|Participant Flow|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20247|NCT02170662|P1|Participant Flow|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20248|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20249|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20250|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20251|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20252|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20253|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20254|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20255|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20256|NCT02170662|E2|Reported Event|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
20257|NCT02170662|E1|Reported Event|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
20258|NCT02170649|B1|Baseline|Fasting Period|single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
20259|NCT02170649|P1|Participant Flow|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20260|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20261|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20262|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20263|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20264|NCT02170649|E1|Reported Event|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
20265|NCT02170532|B1|Baseline|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
20266|NCT02170532|P1|Participant Flow|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
20267|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
20268|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
20269|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
20270|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
20271|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
20272|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
20273|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
20274|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
20275|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
20276|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
20277|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
20278|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
20279|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
20280|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
20281|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
20282|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
20283|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
20284|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
20285|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
20286|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
20287|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
20288|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
20289|NCT02170532|O3|Outcome|Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs|"levalbuterol metered dose inhaler (MDI) 2 puffs~levalbuterol MDI"
20290|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
20291|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
20292|NCT02170532|E1|Reported Event|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
20293|NCT02170519|B3|Baseline|Total|Total of all reporting groups
20294|NCT02170519|B2|Baseline|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20295|NCT02170519|B1|Baseline|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20296|NCT02170519|P2|Participant Flow|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20297|NCT02170519|P1|Participant Flow|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20353|NCT02170376|E5|Reported Event|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20916|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20298|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20299|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20300|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20301|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20302|NCT02170519|O2|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20303|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20304|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20305|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20306|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20307|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20308|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20354|NCT02170376|E4|Reported Event|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20917|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20309|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20310|NCT02170519|E2|Reported Event|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20311|NCT02170519|E1|Reported Event|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
20312|NCT02170376|B6|Baseline|Total|Total of all reporting groups
20313|NCT02170376|B5|Baseline|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20314|NCT02170376|B4|Baseline|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20315|NCT02170376|B3|Baseline|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20316|NCT02170376|B2|Baseline|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20317|NCT02170376|B1|Baseline|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20318|NCT02170376|P5|Participant Flow|Group 5: Placebo Then Levodopa/Carbidopa|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20319|NCT02170376|P4|Participant Flow|Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20320|NCT02170376|P3|Participant Flow|Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20321|NCT02170376|P2|Participant Flow|Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20322|NCT02170376|P1|Participant Flow|Group 1: Placebo Then Entacapone/Levodopa|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20323|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20324|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20325|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20326|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20327|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20328|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20329|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20330|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20331|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20332|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20333|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20334|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20335|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20336|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20337|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20338|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20339|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20340|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20341|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20342|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20343|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20344|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20345|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20346|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20347|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20348|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
20349|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
20350|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
20351|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
20352|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
20846|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20355|NCT02170376|E3|Reported Event|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20356|NCT02170376|E2|Reported Event|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20357|NCT02170376|E1|Reported Event|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
20358|NCT02170220|B3|Baseline|Total|Total of all reporting groups
20359|NCT02170220|B2|Baseline|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20360|NCT02170220|B1|Baseline|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20361|NCT02170220|P2|Participant Flow|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20362|NCT02170220|P1|Participant Flow|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20363|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20364|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20365|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20366|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20367|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20368|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20369|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20370|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20371|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20372|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20373|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20374|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20375|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20376|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20377|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20378|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20379|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20380|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20381|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20382|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20383|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20384|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20385|NCT02170220|E2|Reported Event|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
20386|NCT02170220|E1|Reported Event|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
20387|NCT02170207|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20388|NCT02170207|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20389|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20390|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20391|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20392|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20393|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20394|NCT02170207|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
20395|NCT02170077|B4|Baseline|Total|Total of all reporting groups
20396|NCT02170077|B3|Baseline|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
20397|NCT02170077|B2|Baseline|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
20398|NCT02170077|B1|Baseline|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
20399|NCT02170077|P3|Participant Flow|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
20400|NCT02170077|P2|Participant Flow|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
20401|NCT02170077|P1|Participant Flow|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
20402|NCT02170077|O3|Outcome|PLG - Placebo Group|Intent to treat (TT) Population
20403|NCT02170077|O2|Outcome|TDG - Twice Daily Group|Intent to treat (TT) Population
20404|NCT02170077|O1|Outcome|ODG - Once Daily Group|Intent to treat (TT) Population
20405|NCT02170077|E3|Reported Event|PLG - Placebo Group|Intent to treat (TT) Population
20406|NCT02170077|E2|Reported Event|TDG - Twice Daily Group|Intent to treat (TT) Population
20407|NCT02170077|E1|Reported Event|ODG - Once Daily Group|Intent to treat (TT) Population
20408|NCT02170064|B4|Baseline|Total|Total of all reporting groups
20409|NCT02170064|B3|Baseline|Group 3 (12-17 Yrs)|Efficacy population (EP)
20410|NCT02170064|B2|Baseline|Group 2 (7-11 Yrs)|Efficacy population (EP)
20411|NCT02170064|B1|Baseline|Group 1 (2-6 Yrs)|Efficacy population (EP)
20412|NCT02170064|P3|Participant Flow|Group 3 (12-17 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
20413|NCT02170064|P2|Participant Flow|Group 2 (7-11 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
20414|NCT02170064|P1|Participant Flow|Group 1 (2-6 Yrs)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 1 (2–6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit."
20415|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
20416|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
20417|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
20418|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
20419|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
20420|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
20421|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
20422|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
20423|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
20424|NCT02170064|E3|Reported Event|Group 3 (12-17 Yrs)|Safety population (SP)
20425|NCT02170064|E2|Reported Event|Group 2 (7-11 Yrs)|Safety population (SP)
20426|NCT02170064|E1|Reported Event|Group 1 (2-6 Yrs)|Safety population (SP)
20427|NCT02169895|B5|Baseline|Total|Total of all reporting groups
20428|NCT02169895|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
20847|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20429|NCT02169895|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
20430|NCT02169895|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
20431|NCT02169895|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25"
20432|NCT02169895|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
20433|NCT02169895|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
20434|NCT02169895|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
20435|NCT02169895|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
20436|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
20437|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20438|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20439|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20440|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
20441|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20442|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20443|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20444|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
20445|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20446|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20447|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20448|NCT02169895|E4|Reported Event|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
20449|NCT02169895|E3|Reported Event|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20450|NCT02169895|E2|Reported Event|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20451|NCT02169895|E1|Reported Event|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
20452|NCT02169479|B5|Baseline|Total|Total of all reporting groups
20453|NCT02169479|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20454|NCT02169479|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20455|NCT02169479|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20456|NCT02169479|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20457|NCT02169479|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20458|NCT02169479|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20459|NCT02169479|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20498|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
45496|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
20460|NCT02169479|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
20461|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
20462|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20463|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20464|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20465|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
20466|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20467|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20468|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20469|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
20470|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20471|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20472|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20473|NCT02169479|E4|Reported Event|Placebo|Placebo, PLC
20474|NCT02169479|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20475|NCT02169479|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20476|NCT02169479|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20477|NCT02169466|B5|Baseline|Total|Total of all reporting groups
20478|NCT02169466|B4|Baseline|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20479|NCT02169466|B3|Baseline|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20480|NCT02169466|B2|Baseline|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20481|NCT02169466|B1|Baseline|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20482|NCT02169466|P4|Participant Flow|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20483|NCT02169466|P3|Participant Flow|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20484|NCT02169466|P2|Participant Flow|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20485|NCT02169466|P1|Participant Flow|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
20486|NCT02169466|O4|Outcome|Placebo|Placebo, PLC
20487|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20488|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20489|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20490|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
20491|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20492|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20493|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
20494|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
20495|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20496|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20497|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
20499|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20501|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
20502|NCT02169466|E4|Reported Event|Placebo|Placebo, PLC
20503|NCT02169466|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20504|NCT02169466|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20505|NCT02169466|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20506|NCT02169453|B5|Baseline|Total|Total of all reporting groups
20507|NCT02169453|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20508|NCT02169453|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20509|NCT02169453|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20510|NCT02169453|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20511|NCT02169453|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20512|NCT02169453|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20513|NCT02169453|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20514|NCT02169453|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
20515|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20516|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20517|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20518|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20519|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20520|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20521|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20522|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20523|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20524|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20525|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20526|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20527|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20528|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20529|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20530|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20531|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20532|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20533|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20534|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20535|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
20536|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20537|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20538|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20539|NCT02169453|E4|Reported Event|Placebo|Placebo, PLC
20540|NCT02169453|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
20541|NCT02169453|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
20542|NCT02169453|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
20543|NCT02169440|B3|Baseline|Total|Total of all reporting groups
20544|NCT02169440|B2|Baseline|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
20545|NCT02169440|B1|Baseline|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
20848|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20546|NCT02169440|P2|Participant Flow|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
20547|NCT02169440|P1|Participant Flow|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
20548|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
20549|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
20550|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
20551|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
20552|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
20553|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
20554|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
20555|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
20556|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
20557|NCT02169440|E2|Reported Event|Warfarin|Warfarin 25 mg
20558|NCT02169440|E1|Reported Event|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg Warfarin 25 mg
20559|NCT02169427|B1|Baseline|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20560|NCT02169427|P1|Participant Flow|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20561|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20562|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20563|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20564|NCT02169427|E1|Reported Event|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
20565|NCT02169414|B5|Baseline|Total|Total of all reporting groups
20566|NCT02169414|B4|Baseline|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20567|NCT02169414|B3|Baseline|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20568|NCT02169414|B2|Baseline|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20569|NCT02169414|B1|Baseline|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20570|NCT02169414|P4|Participant Flow|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20571|NCT02169414|P3|Participant Flow|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20572|NCT02169414|P2|Participant Flow|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20573|NCT02169414|P1|Participant Flow|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20574|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20575|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20576|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20577|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20578|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20579|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20580|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20581|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20582|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20583|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20584|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20585|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20586|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20587|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20588|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20589|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
20590|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20591|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
20592|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20593|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20594|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20595|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
20596|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20597|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20598|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20599|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
20600|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20601|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20602|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20603|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
20604|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20605|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
20849|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20850|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20606|NCT02169414|E4|Reported Event|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20607|NCT02169414|E3|Reported Event|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20608|NCT02169414|E2|Reported Event|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20609|NCT02169414|E1|Reported Event|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
20610|NCT02169336|B4|Baseline|Total|Total of all reporting groups
20611|NCT02169336|B3|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
20612|NCT02169336|B2|Baseline|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20613|NCT02169336|B1|Baseline|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20614|NCT02169336|P3|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
20615|NCT02169336|P2|Participant Flow|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20616|NCT02169336|P1|Participant Flow|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20617|NCT02169336|O3|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
20618|NCT02169336|O2|Outcome|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20619|NCT02169336|O1|Outcome|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20620|NCT02169336|E3|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
20621|NCT02169336|E2|Reported Event|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20622|NCT02169336|E1|Reported Event|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
20623|NCT02169115|B4|Baseline|Total|Total of all reporting groups
20624|NCT02169115|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
20625|NCT02169115|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
20626|NCT02169115|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
20627|NCT02169115|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
20628|NCT02169115|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
20629|NCT02169115|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
20630|NCT02169115|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
20631|NCT02169115|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
20632|NCT02169115|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
20633|NCT02169115|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
20634|NCT02169115|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
20635|NCT02169115|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
20636|NCT02168478|B1|Baseline|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae."
20637|NCT02168478|P1|Participant Flow|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Saline is applied to the absorbent pad portion of a"
20670|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
20851|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20638|NCT02168478|O1|Outcome|Patch Test Group|"Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours."
20639|NCT02168478|E1|Reported Event|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.~Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae."
20640|NCT02168387|B3|Baseline|Total|Total of all reporting groups
20641|NCT02168387|B2|Baseline|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
20642|NCT02168387|B1|Baseline|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
20643|NCT02168387|P2|Participant Flow|Continuous High Frequency Oscillator (CHFO)|"Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.~continuous high frequency oscillator (CHFO)"
20644|NCT02168387|P1|Participant Flow|Medication|"Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.~Acetylcysteine~dornase alfa"
20645|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
20646|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
20647|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
20648|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
20649|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
20650|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
20651|NCT02168387|E2|Reported Event|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
20652|NCT02168387|E1|Reported Event|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
20653|NCT02168361|B3|Baseline|Total|Total of all reporting groups
20654|NCT02168361|B2|Baseline|Interferon-containing Arm|
20655|NCT02168361|B1|Baseline|Oral Therapy Arm|
20656|NCT02168361|P2|Participant Flow|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
20657|NCT02168361|P1|Participant Flow|All Oral Therapy|Simeprevir-sofosbuvir
20658|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
20659|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
20660|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
20661|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
20662|NCT02168361|E2|Reported Event|Interferon-containing|
20663|NCT02168361|E1|Reported Event|All Oral|
20664|NCT02167867|B3|Baseline|Total|Total of all reporting groups
20665|NCT02167867|B2|Baseline|Treatment Subject Group|Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
20666|NCT02167867|B1|Baseline|Lay End Users|Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
20667|NCT02167867|P2|Participant Flow|Treatment Subject Group|Subjects who received active treatments with the study device administered by the Lay End Users.
20668|NCT02167867|P1|Participant Flow|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject.
20669|NCT02167867|O1|Outcome|Treatment Subject Group|Individuals who got the active treatments with the ZERONA Z6.
20852|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
45497|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
20671|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
20672|NCT02167867|E1|Reported Event|ZERONA Z6|"ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.~ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs."
20673|NCT02167815|B3|Baseline|Total|Total of all reporting groups
20674|NCT02167815|B2|Baseline|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20675|NCT02167815|B1|Baseline|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
20676|NCT02167815|P2|Participant Flow|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20677|NCT02167815|P1|Participant Flow|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
20678|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20679|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites, standard care
20680|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20681|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites standard care
20682|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20683|NCT02167815|O2|Outcome|Standard Care|observation group, treating according to investigation sites standard care
20684|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20685|NCT02167815|E2|Reported Event|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
20686|NCT02167815|E1|Reported Event|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
20687|NCT02167139|B3|Baseline|Total|Total of all reporting groups
20688|NCT02167139|B2|Baseline|Humira (Adalimumab)|"Humira 40 mg every other week via subcutaneous injection~Humira (adalimumab)~SB5 (proposed biosimilar to adalimumab)"
20689|NCT02167139|B1|Baseline|SB5 (Proposed Biosimilar to Adalimumab)|"SB5 40 mg every other week via subcutaneous injection~SB5 (proposed biosimilar to adalimumab)"
20690|NCT02167139|P4|Participant Flow|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
20691|NCT02167139|P3|Participant Flow|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20692|NCT02167139|P2|Participant Flow|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20693|NCT02167139|P1|Participant Flow|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
20694|NCT02167139|O5|Outcome|Humira (Adalimumab), Continue as Humira at Week 52|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
20695|NCT02167139|O4|Outcome|Humira (Adalimumab), Switch to SB5 at Week 52|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20696|NCT02167139|O3|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 52|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
20697|NCT02167139|O2|Outcome|Humira (Adalimumab) at Week 24|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20698|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 24|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
20699|NCT02167139|O3|Outcome|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
20700|NCT02167139|O2|Outcome|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20701|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
20702|NCT02167139|O2|Outcome|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection up to Week 24
20703|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection up to Week 24
20704|NCT02167139|E2|Reported Event|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
20705|NCT02167139|E1|Reported Event|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
20706|NCT02166697|B1|Baseline|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20707|NCT02166697|P1|Participant Flow|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20708|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20709|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20710|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20711|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20712|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20713|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20714|NCT02166697|E1|Reported Event|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
20853|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20918|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20715|NCT02165462|B1|Baseline|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20716|NCT02165462|P1|Participant Flow|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20717|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20718|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20719|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20720|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20721|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20722|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20723|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20724|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20725|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20726|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20727|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20728|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20729|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20730|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20731|NCT02165462|E1|Reported Event|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
20732|NCT02165111|B3|Baseline|Total|Total of all reporting groups
20733|NCT02165111|B2|Baseline|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20734|NCT02165111|B1|Baseline|Onabotulinumtoxin A|"One hand of each patient was be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20735|NCT02165111|P2|Participant Flow|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each)."
20736|NCT02165111|P1|Participant Flow|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand."
20737|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20738|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20739|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20740|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20741|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20742|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20743|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20744|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20745|NCT02165111|O2|Outcome|Placebo|"One hand of each patient were randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20746|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient were randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20747|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20767|NCT02164539|P3|Participant Flow|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20854|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20748|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20749|NCT02165111|E2|Reported Event|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
20750|NCT02165111|E1|Reported Event|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
20751|NCT02165072|B1|Baseline|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
20752|NCT02165072|P1|Participant Flow|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
20753|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
20754|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
20755|NCT02165072|E1|Reported Event|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
20756|NCT02164539|B7|Baseline|Total|Total of all reporting groups
20757|NCT02164539|B6|Baseline|FF/VI 100/25 µg|Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20758|NCT02164539|B5|Baseline|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20759|NCT02164539|B4|Baseline|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20760|NCT02164539|B3|Baseline|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20761|NCT02164539|B2|Baseline|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20762|NCT02164539|B1|Baseline|FF 100 µg|Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20763|NCT02164539|P7|Participant Flow|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20764|NCT02164539|P6|Participant Flow|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20765|NCT02164539|P5|Participant Flow|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20766|NCT02164539|P4|Participant Flow|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20843|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20844|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20768|NCT02164539|P2|Participant Flow|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20769|NCT02164539|P1|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20770|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20771|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20772|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20773|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20774|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20775|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20776|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20777|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20778|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20779|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20780|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20781|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20782|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20783|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20784|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20785|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20786|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20787|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20788|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20789|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20790|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20791|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20792|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20793|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20794|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20795|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20796|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20797|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20798|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20799|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20800|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20801|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20802|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20803|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20804|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20805|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20806|NCT02164539|E7|Reported Event|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20807|NCT02164539|E6|Reported Event|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20808|NCT02164539|E5|Reported Event|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20845|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
45498|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
20809|NCT02164539|E4|Reported Event|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20810|NCT02164539|E3|Reported Event|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20811|NCT02164539|E2|Reported Event|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
20812|NCT02164539|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
20813|NCT02164396|B4|Baseline|Total|Total of all reporting groups
20814|NCT02164396|B3|Baseline|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
20815|NCT02164396|B2|Baseline|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
20816|NCT02164396|B1|Baseline|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
20817|NCT02164396|P3|Participant Flow|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
20818|NCT02164396|P2|Participant Flow|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
20819|NCT02164396|P1|Participant Flow|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
20820|NCT02164396|O3|Outcome|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
20821|NCT02164396|O2|Outcome|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
20822|NCT02164396|O1|Outcome|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
20823|NCT02164396|E3|Reported Event|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
20824|NCT02164396|E2|Reported Event|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
20825|NCT02164396|E1|Reported Event|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
20826|NCT02163915|B6|Baseline|Total|Total of all reporting groups
20827|NCT02163915|B5|Baseline|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20828|NCT02163915|B4|Baseline|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20829|NCT02163915|B3|Baseline|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20830|NCT02163915|B2|Baseline|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20831|NCT02163915|B1|Baseline|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20832|NCT02163915|P5|Participant Flow|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20833|NCT02163915|P4|Participant Flow|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20834|NCT02163915|P3|Participant Flow|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20835|NCT02163915|P2|Participant Flow|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20836|NCT02163915|P1|Participant Flow|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20837|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20838|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20839|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20840|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20841|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20842|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20855|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20856|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20857|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20858|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20859|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20860|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20861|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20862|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20863|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20864|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20865|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20866|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20867|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20868|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20869|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20870|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20871|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20872|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20873|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20874|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20875|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20876|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20877|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20878|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20879|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20880|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20881|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20882|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20883|NCT02163915|E5|Reported Event|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
20884|NCT02163915|E4|Reported Event|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
20885|NCT02163915|E3|Reported Event|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
20886|NCT02163915|E2|Reported Event|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
20887|NCT02163915|E1|Reported Event|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
20888|NCT02163733|B3|Baseline|Total|Total of all reporting groups
20889|NCT02163733|B2|Baseline|Fasted/Fed|AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
20890|NCT02163733|B1|Baseline|Fed/Fasted|AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
20891|NCT02163733|P2|Participant Flow|Fasted/Fed|AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
20892|NCT02163733|P1|Participant Flow|Fed/Fasted|AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
20893|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20894|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20895|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20896|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20897|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20898|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20899|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20900|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20901|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20902|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20903|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20904|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20905|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20906|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20907|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20908|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20909|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
45499|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
20919|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20920|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20921|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
20922|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20923|NCT02163733|E3|Reported Event|Overall|Fed and Fasted periods combined.
20924|NCT02163733|E2|Reported Event|Fasted|AZD9291 tablets following a period of fasting
20925|NCT02163733|E1|Reported Event|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
20926|NCT02163421|B5|Baseline|Total|Total of all reporting groups
20927|NCT02163421|B4|Baseline|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20928|NCT02163421|B3|Baseline|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20929|NCT02163421|B2|Baseline|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20930|NCT02163421|B1|Baseline|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
20931|NCT02163421|P4|Participant Flow|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20932|NCT02163421|P3|Participant Flow|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20933|NCT02163421|P2|Participant Flow|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20934|NCT02163421|P1|Participant Flow|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
20935|NCT02163421|O1|Outcome|Vedolizumab Subcutaneous|Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20936|NCT02163421|E4|Reported Event|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20937|NCT02163421|E3|Reported Event|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20938|NCT02163421|E2|Reported Event|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
20939|NCT02163421|E1|Reported Event|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
20940|NCT02163395|B1|Baseline|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20941|NCT02163395|P1|Participant Flow|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20942|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20943|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20944|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20945|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20946|NCT02163395|E1|Reported Event|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
20947|NCT02162979|B3|Baseline|Total|Total of all reporting groups
20948|NCT02162979|B2|Baseline|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
20949|NCT02162979|B1|Baseline|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
20950|NCT02162979|P2|Participant Flow|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
20951|NCT02162979|P1|Participant Flow|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
20952|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
20953|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
20954|NCT02162979|E2|Reported Event|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
20955|NCT02162979|E1|Reported Event|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
20956|NCT02162680|B4|Baseline|Total|Total of all reporting groups
20957|NCT02162680|B3|Baseline|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
20958|NCT02162680|B2|Baseline|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
20959|NCT02162680|B1|Baseline|no Local Anesthetic|usual care practice of no local anesthetic administration
20960|NCT02162680|P3|Participant Flow|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
20961|NCT02162680|P2|Participant Flow|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
20962|NCT02162680|P1|Participant Flow|no Local Anesthetic|usual care practice of no local anesthetic administration
20963|NCT02162680|O3|Outcome|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
20964|NCT02162680|O2|Outcome|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
20965|NCT02162680|O1|Outcome|no Local Anesthetic|usual care practice of no local anesthetic administration
20966|NCT02162680|E3|Reported Event|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
20967|NCT02162680|E2|Reported Event|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
20968|NCT02162680|E1|Reported Event|no Local Anesthetic|usual care practice of no local anesthetic administration
20969|NCT02161146|B6|Baseline|Total|Total of all reporting groups
20970|NCT02161146|B5|Baseline|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
20971|NCT02161146|B4|Baseline|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
20972|NCT02161146|B3|Baseline|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
20973|NCT02161146|B2|Baseline|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
20974|NCT02161146|B1|Baseline|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
20975|NCT02161146|P5|Participant Flow|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
20976|NCT02161146|P4|Participant Flow|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
20977|NCT02161146|P3|Participant Flow|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
20978|NCT02161146|P2|Participant Flow|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
20979|NCT02161146|P1|Participant Flow|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
20980|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
20981|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
20982|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
20983|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
20984|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
20985|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
20986|NCT02161146|E5|Reported Event|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
20987|NCT02161146|E4|Reported Event|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
20988|NCT02161146|E3|Reported Event|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
20989|NCT02161146|E2|Reported Event|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
20990|NCT02161146|E1|Reported Event|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
20991|NCT02161016|B1|Baseline|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20992|NCT02161016|P1|Participant Flow|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20993|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20994|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20995|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20996|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20997|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20998|NCT02161016|E1|Reported Event|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
20999|NCT02160990|B3|Baseline|Total|Total of all reporting groups
21000|NCT02160990|B2|Baseline|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21001|NCT02160990|B1|Baseline|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21002|NCT02160990|P2|Participant Flow|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21003|NCT02160990|P1|Participant Flow|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21004|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21005|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21006|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21007|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21008|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21009|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21010|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21011|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21012|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21013|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21014|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21015|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21016|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21017|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21018|NCT02160990|E2|Reported Event|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
21019|NCT02160990|E1|Reported Event|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
21020|NCT02160977|B3|Baseline|Total|Total of all reporting groups
21021|NCT02160977|B2|Baseline|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21022|NCT02160977|B1|Baseline|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21023|NCT02160977|P2|Participant Flow|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21024|NCT02160977|P1|Participant Flow|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21025|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21026|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21027|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21028|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21029|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21030|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21031|NCT02160977|E2|Reported Event|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
21032|NCT02160977|E1|Reported Event|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
21033|NCT02160314|B3|Baseline|Total|Total of all reporting groups
21034|NCT02160314|B2|Baseline|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
21035|NCT02160314|B1|Baseline|Pad Control|"absorbent pad control~Absorbent pad"
21036|NCT02160314|P2|Participant Flow|Pessary|pessary: disposable, single-use
21037|NCT02160314|P1|Participant Flow|Pad Control|absorbent pad control
21038|NCT02160314|O2|Outcome|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
21039|NCT02160314|O1|Outcome|Pad Control|"absorbent pad control~Absorbent pad"
21040|NCT02160314|E2|Reported Event|Pessary|disposable, single-use pessary
21041|NCT02160314|E1|Reported Event|Pad Control|absorbent pad control
21042|NCT02159950|B3|Baseline|Total|Total of all reporting groups
21043|NCT02159950|B2|Baseline|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21044|NCT02159950|B1|Baseline|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21045|NCT02159950|P2|Participant Flow|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21046|NCT02159950|P1|Participant Flow|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21047|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21048|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21263|NCT02157883|E1|Reported Event|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21264|NCT02157376|B3|Baseline|Total|Total of all reporting groups
21049|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21050|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21051|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21052|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21053|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21054|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21055|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21056|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21057|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21058|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21059|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21060|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21061|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21062|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21063|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21064|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21065|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21066|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21067|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21068|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21069|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21070|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21071|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21072|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21073|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21074|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21075|NCT02159950|E2|Reported Event|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
21076|NCT02159950|E1|Reported Event|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
21077|NCT02159768|B1|Baseline|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
21078|NCT02159768|P1|Participant Flow|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
21079|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
21080|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
21081|NCT02159768|E1|Reported Event|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
21082|NCT02159547|B3|Baseline|Total|Total of all reporting groups
21083|NCT02159547|B2|Baseline|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
21084|NCT02159547|B1|Baseline|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
21085|NCT02159547|P2|Participant Flow|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
21086|NCT02159547|P1|Participant Flow|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
21087|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
21088|NCT02159547|O1|Outcome|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
21089|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
21090|NCT02159547|O1|Outcome|Dexketoprofen|50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
21091|NCT02159547|E2|Reported Event|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
21092|NCT02159547|E1|Reported Event|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
21093|NCT02159482|B1|Baseline|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
21094|NCT02159482|P1|Participant Flow|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
21095|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
21096|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
21097|NCT02159482|E1|Reported Event|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
21265|NCT02157376|B2|Baseline|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
45500|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
21098|NCT02159365|B1|Baseline|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
21099|NCT02159365|P1|Participant Flow|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
21100|NCT02159365|O1|Outcome|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
21101|NCT02159365|E1|Reported Event|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
21102|NCT02159352|B3|Baseline|Total|Total of all reporting groups
21103|NCT02159352|B2|Baseline|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21104|NCT02159352|B1|Baseline|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21105|NCT02159352|P2|Participant Flow|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21106|NCT02159352|P1|Participant Flow|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21107|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21108|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21109|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21110|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21111|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
21112|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21113|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21114|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21115|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
21116|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21117|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14.
21118|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21119|NCT02159352|O2|Outcome|Group 2: Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
45501|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
21120|NCT02159352|O1|Outcome|Group 1: Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21121|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 -mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21122|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21123|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21124|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21125|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21126|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21127|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21128|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21129|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
21130|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
21131|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21132|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21133|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21134|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
21135|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21136|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21137|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
21138|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21139|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21140|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21141|NCT02159352|O4|Outcome|Daclatasvir (30 mg) + Lopinavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
21142|NCT02159352|O3|Outcome|Daclatasvir (60 mg) Days 5-14|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
21143|NCT02159352|O2|Outcome|Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21144|NCT02159352|O1|Outcome|Daclatasvir (60 mg) Days 1-4|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21145|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
21146|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
21147|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14.
21148|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21149|NCT02159352|E6|Reported Event|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
21150|NCT02159352|E5|Reported Event|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21151|NCT02159352|E4|Reported Event|Group 2: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100­-mg ritonavir capsule once daily on Days 5 through 14.
21152|NCT02159352|E3|Reported Event|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
21153|NCT02159352|E2|Reported Event|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
21154|NCT02159352|E1|Reported Event|Group 1: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and 30 mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
21155|NCT02159118|B3|Baseline|Total|Total of all reporting groups
21156|NCT02159118|B2|Baseline|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21157|NCT02159118|B1|Baseline|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21158|NCT02159118|P2|Participant Flow|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21159|NCT02159118|P1|Participant Flow|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21160|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21161|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21162|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21163|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21164|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21165|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21166|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21167|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21168|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21169|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21170|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21171|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21172|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21173|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21174|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21175|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21176|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21177|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21178|NCT02159118|E2|Reported Event|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21266|NCT02157376|B1|Baseline|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
21179|NCT02159118|E1|Reported Event|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
21180|NCT02159040|B1|Baseline|Azacitidine|75mg/m2 7days/28 day cycle
21181|NCT02159040|P1|Participant Flow|Azacitidine|75mg/m2 7days/28 day cycle
21182|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21183|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21184|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21185|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21186|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21187|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21188|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21189|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21190|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21191|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
21192|NCT02159040|E1|Reported Event|Azacitidine|75mg/m2 7days/28 day cycle
21193|NCT02158442|B3|Baseline|Total|Total of all reporting groups
21194|NCT02158442|B2|Baseline|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
21195|NCT02158442|B1|Baseline|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
21196|NCT02158442|P2|Participant Flow|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
21197|NCT02158442|P1|Participant Flow|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
21198|NCT02158442|O2|Outcome|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
21199|NCT02158442|O1|Outcome|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
21200|NCT02158442|E2|Reported Event|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
21201|NCT02158442|E1|Reported Event|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
21202|NCT02158247|B3|Baseline|Total|Total of all reporting groups
21203|NCT02158247|B2|Baseline|Touch and Read Group(Female)|female
21204|NCT02158247|B1|Baseline|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
21205|NCT02158247|P1|Participant Flow|Tough and Read Group|"This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
21206|NCT02158247|O1|Outcome|Female Airway Length vs Height|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
21207|NCT02158247|O1|Outcome|Airway Length vs Height in Male|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
21208|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Female|
21209|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Female|
21210|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Female|
21211|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Female|
21212|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Male|
21213|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Male|
21214|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Male|
21215|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Male|
21216|NCT02158247|O2|Outcome|Airway Length of Female|
21217|NCT02158247|O1|Outcome|Airway Length for Male|
21218|NCT02158247|E2|Reported Event|Touch and Read Group(Female)|female
21219|NCT02158247|E1|Reported Event|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
21220|NCT02158039|B1|Baseline|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
21221|NCT02158039|P1|Participant Flow|Pancreatic Cyst Ethanol Injection|Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
21222|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
21223|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
21224|NCT02158039|E1|Reported Event|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
21225|NCT02157909|B3|Baseline|Total|Total of all reporting groups
21226|NCT02157909|B2|Baseline|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21227|NCT02157909|B1|Baseline|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21228|NCT02157909|P2|Participant Flow|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21229|NCT02157909|P1|Participant Flow|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21230|NCT02157909|O2|Outcome|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21231|NCT02157909|O1|Outcome|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
21232|NCT02157909|E3|Reported Event|AOA Sphere|Includes all subjects / eyes exposed to AOA Sphere lenses
21233|NCT02157909|E2|Reported Event|AOA Modified|Includes all subjects / eyes exposed to AOA Modified lenses
21234|NCT02157909|E1|Reported Event|Pre-treatment|Includes all subjects / eyes prior to the exposure to the investigational or control products
21235|NCT02157883|B1|Baseline|AZD9291 Alone,AZD9291+Itraconozole|Sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole.
21236|NCT02157883|P1|Participant Flow|AZD9291 Alone,AZD9291+Itraconozole|Sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole.
21237|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21238|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21239|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21240|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21241|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21242|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21243|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21244|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21245|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21246|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21247|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21248|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21249|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21250|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21251|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21252|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21253|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21254|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21255|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21256|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21257|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21258|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21259|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21260|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
21261|NCT02157883|E3|Reported Event|Overall|AZD9291 in Period 1 and AZD9291 + itrazonazole in Period 2
21262|NCT02157883|E2|Reported Event|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
21267|NCT02157376|P2|Participant Flow|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
21268|NCT02157376|P1|Participant Flow|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
21269|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
21270|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
21271|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
21272|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
21273|NCT02157376|E2|Reported Event|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
21274|NCT02157376|E1|Reported Event|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
21275|NCT02157298|B3|Baseline|Total|Total of all reporting groups
21276|NCT02157298|B2|Baseline|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21277|NCT02157298|B1|Baseline|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21278|NCT02157298|P2|Participant Flow|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21279|NCT02157298|P1|Participant Flow|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21280|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21281|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21282|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21283|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21284|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21285|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21286|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21287|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21288|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21289|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21290|NCT02157298|E2|Reported Event|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
21291|NCT02157298|E1|Reported Event|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
21292|NCT02157116|B1|Baseline|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
21293|NCT02157116|P1|Participant Flow|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
21294|NCT02157116|O1|Outcome|Treated Patients|
21295|NCT02157116|O1|Outcome|Treated Patients|
21296|NCT02157116|O1|Outcome|Treated Patients|
21297|NCT02157116|O1|Outcome|Treated Patients|
21298|NCT02157116|O1|Outcome|Treated Patients|
21299|NCT02157116|O1|Outcome|Treated Patients|
21300|NCT02157116|E1|Reported Event|Treated Patients|Due to insufficient accrual, adverse event data was not analyzed.
21301|NCT02156466|B6|Baseline|Total|Total of all reporting groups
21302|NCT02156466|B5|Baseline|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21303|NCT02156466|B4|Baseline|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21304|NCT02156466|B3|Baseline|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21305|NCT02156466|B2|Baseline|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21306|NCT02156466|B1|Baseline|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21307|NCT02156466|P5|Participant Flow|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21308|NCT02156466|P4|Participant Flow|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21309|NCT02156466|P3|Participant Flow|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21310|NCT02156466|P2|Participant Flow|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21311|NCT02156466|P1|Participant Flow|MSB0010841 30 mg|MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21312|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21313|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21314|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21315|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21316|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21317|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21318|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21319|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21320|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21321|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21322|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.
21323|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.
21324|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.
21325|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.
21326|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.
21327|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21328|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21329|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21330|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21331|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21332|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21333|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21334|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21335|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21336|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21337|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21338|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21339|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21340|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21341|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21342|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21343|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21344|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21345|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21346|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21347|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21348|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21349|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21350|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21351|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21352|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21353|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21354|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21355|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21356|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21357|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21358|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21359|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21360|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21361|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21362|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21363|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21364|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21365|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21366|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21367|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21368|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21369|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21370|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21371|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21372|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21373|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21374|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21375|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21376|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21377|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21378|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21379|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21380|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21381|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21382|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21383|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21384|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21385|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21386|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21387|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21388|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21389|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21390|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21391|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21392|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21393|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21394|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21395|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21396|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21397|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21398|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21399|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21400|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21401|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21402|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21403|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21404|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21405|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21406|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21407|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21408|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21409|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21410|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21411|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21412|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21413|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21414|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21415|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21416|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21417|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21418|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21419|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21420|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21421|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21422|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21423|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21424|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21425|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21426|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21427|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21428|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21429|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21430|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21431|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21432|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21433|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21434|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21435|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21436|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21437|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21438|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21439|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21440|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21441|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21442|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21443|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21444|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21445|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21446|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21447|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21448|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21449|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21450|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21451|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21452|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21453|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21454|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21455|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21456|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21457|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21458|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21459|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21460|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21461|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21462|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21463|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21464|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21465|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
21466|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
21467|NCT02156466|O2|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21468|NCT02156466|O1|Outcome|MSB0010841 Combined|All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks
21469|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21470|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21471|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21472|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21473|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21474|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21475|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21476|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21477|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21478|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21479|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21480|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21481|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21482|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21483|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21484|NCT02156466|E5|Reported Event|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21485|NCT02156466|E4|Reported Event|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21486|NCT02156466|E3|Reported Event|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21487|NCT02156466|E2|Reported Event|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21488|NCT02156466|E1|Reported Event|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
21489|NCT02156271|B3|Baseline|Total|Total of all reporting groups
21490|NCT02156271|B2|Baseline|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21491|NCT02156271|B1|Baseline|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21492|NCT02156271|P2|Participant Flow|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21493|NCT02156271|P1|Participant Flow|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21494|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21495|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21496|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21497|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
45502|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
21498|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21499|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21500|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21501|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21502|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21503|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21504|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21505|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21506|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21507|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21508|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21509|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21510|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21511|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21512|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21513|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21514|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21515|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21516|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21517|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21518|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21519|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21520|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21521|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21522|NCT02156271|E2|Reported Event|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
21523|NCT02156271|E1|Reported Event|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
21524|NCT02156167|B1|Baseline|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
21525|NCT02156167|P1|Participant Flow|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
21526|NCT02156167|O1|Outcome|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
21527|NCT02156167|E1|Reported Event|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
21528|NCT02155985|B4|Baseline|Total|Total of all reporting groups
21529|NCT02155985|B3|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
21530|NCT02155985|B2|Baseline|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21531|NCT02155985|B1|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21532|NCT02155985|P3|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
21533|NCT02155985|P2|Participant Flow|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21534|NCT02155985|P1|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21571|NCT02155543|B1|Baseline|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21535|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
21536|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21537|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21538|NCT02155985|E3|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
21539|NCT02155985|E2|Reported Event|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21540|NCT02155985|E1|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
21541|NCT02155881|B3|Baseline|Total|Total of all reporting groups
21542|NCT02155881|B2|Baseline|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21543|NCT02155881|B1|Baseline|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21544|NCT02155881|P2|Participant Flow|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21545|NCT02155881|P1|Participant Flow|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21546|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21547|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21548|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21549|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21550|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21551|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21552|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21553|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21554|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21555|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21556|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21557|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21558|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21559|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21560|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21561|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21562|NCT02155881|E2|Reported Event|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
21563|NCT02155881|E1|Reported Event|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
21564|NCT02155543|B8|Baseline|Total|Total of all reporting groups
21565|NCT02155543|B7|Baseline|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21566|NCT02155543|B6|Baseline|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21567|NCT02155543|B5|Baseline|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
21568|NCT02155543|B4|Baseline|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
21569|NCT02155543|B3|Baseline|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
21570|NCT02155543|B2|Baseline|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
45503|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
21572|NCT02155543|P7|Participant Flow|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21573|NCT02155543|P6|Participant Flow|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21574|NCT02155543|P5|Participant Flow|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
21575|NCT02155543|P4|Participant Flow|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
21576|NCT02155543|P3|Participant Flow|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
21577|NCT02155543|P2|Participant Flow|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21578|NCT02155543|P1|Participant Flow|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21579|NCT02155543|O4|Outcome|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
21580|NCT02155543|O3|Outcome|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
21581|NCT02155543|O2|Outcome|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21582|NCT02155543|O1|Outcome|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21583|NCT02155543|E7|Reported Event|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
21584|NCT02155543|E6|Reported Event|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21585|NCT02155543|E5|Reported Event|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
21586|NCT02155543|E4|Reported Event|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
21587|NCT02155543|E3|Reported Event|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
21588|NCT02155543|E2|Reported Event|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21589|NCT02155543|E1|Reported Event|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
21590|NCT02155335|B1|Baseline|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
21591|NCT02155335|P2|Participant Flow|Smartject™ Device→ Prefilled Syringe|Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
21592|NCT02155335|P1|Participant Flow|Prefilled Syringe→Smartject™ Device|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
21593|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
21594|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
21595|NCT02155335|E1|Reported Event|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
21596|NCT02155283|B1|Baseline|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
21776|NCT02153398|P3|Participant Flow|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21597|NCT02155283|P1|Participant Flow|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
21598|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
21599|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
21600|NCT02155283|E1|Reported Event|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
21601|NCT02155010|B3|Baseline|Total|Total of all reporting groups
21602|NCT02155010|B2|Baseline|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
21603|NCT02155010|B1|Baseline|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
21604|NCT02155010|P2|Participant Flow|Dexmedetomidine After Bupivacaine|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
21605|NCT02155010|P1|Participant Flow|Dexmedetomidine Before Bupivacaine|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
21606|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
21607|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
21608|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
21609|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
21610|NCT02155010|E2|Reported Event|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
21611|NCT02155010|E1|Reported Event|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
21612|NCT02154906|B3|Baseline|Total|Total of all reporting groups
21613|NCT02154906|B2|Baseline|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
21614|NCT02154906|B1|Baseline|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
21615|NCT02154906|P2|Participant Flow|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
21616|NCT02154906|P1|Participant Flow|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
21617|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
21618|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
21619|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
21620|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
21621|NCT02154906|E2|Reported Event|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
21622|NCT02154906|E1|Reported Event|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
21623|NCT02154425|B1|Baseline|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
21624|NCT02154425|P1|Participant Flow|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
21625|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21626|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21627|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21628|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21629|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21630|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21631|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21632|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21633|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
21634|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21635|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21636|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21637|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21638|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21639|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21640|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21641|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21642|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21643|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21644|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21645|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21646|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21647|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21648|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21649|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
21650|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
21651|NCT02154425|E2|Reported Event|SS-I|This arm consisted of all infants of mothers in the SS-M.
21652|NCT02154425|E1|Reported Event|SS-M|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
21653|NCT02154386|B3|Baseline|Total|Total of all reporting groups
21654|NCT02154386|B2|Baseline|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21655|NCT02154386|B1|Baseline|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21656|NCT02154386|P2|Participant Flow|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21657|NCT02154386|P1|Participant Flow|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21658|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21659|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21660|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21777|NCT02153398|P2|Participant Flow|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
45504|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
21661|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21662|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21663|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21664|NCT02154386|E2|Reported Event|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21665|NCT02154386|E1|Reported Event|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
21666|NCT02154139|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21667|NCT02154139|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21668|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21669|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21670|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21671|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21672|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21673|NCT02154139|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
21674|NCT02154087|B1|Baseline|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
21675|NCT02154087|P1|Participant Flow|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
21676|NCT02154087|O1|Outcome|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
21677|NCT02154087|E1|Reported Event|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
21678|NCT02154048|B4|Baseline|Total|Total of all reporting groups
21679|NCT02154048|B3|Baseline|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
21680|NCT02154048|B2|Baseline|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
21681|NCT02154048|B1|Baseline|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
21682|NCT02154048|P3|Participant Flow|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
21683|NCT02154048|P2|Participant Flow|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
21684|NCT02154048|P1|Participant Flow|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
21685|NCT02154048|O3|Outcome|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
21686|NCT02154048|O2|Outcome|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
21778|NCT02153398|P1|Participant Flow|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
45505|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
21687|NCT02154048|O1|Outcome|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
21688|NCT02154048|E3|Reported Event|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
21689|NCT02154048|E2|Reported Event|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
21690|NCT02154048|E1|Reported Event|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
21691|NCT02153827|B3|Baseline|Total|Total of all reporting groups
21692|NCT02153827|B2|Baseline|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21693|NCT02153827|B1|Baseline|Eccentric External Rotator Training|"Eccentric Shoulder External Rotator Training~Eccentric Shoulder External Rotator Training"
21694|NCT02153827|P2|Participant Flow|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21695|NCT02153827|P1|Participant Flow|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21696|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21697|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21698|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21699|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21700|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21701|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21702|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21703|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21704|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21705|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21706|NCT02153827|E2|Reported Event|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
21707|NCT02153827|E1|Reported Event|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
21708|NCT02153788|B3|Baseline|Total|Total of all reporting groups
21709|NCT02153788|B2|Baseline|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21710|NCT02153788|B1|Baseline|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21711|NCT02153788|P2|Participant Flow|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21712|NCT02153788|P1|Participant Flow|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21713|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21714|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21715|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21716|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21717|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21718|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21779|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21780|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21719|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21720|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21721|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21722|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21723|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21724|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21725|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21726|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21727|NCT02153788|E2|Reported Event|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
21728|NCT02153788|E1|Reported Event|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
21729|NCT02153489|B1|Baseline|Overall Study|All patients participating in the crossover study
21730|NCT02153489|P2|Participant Flow|Sequence B|Placebo - Aclidinium 400 μg
21731|NCT02153489|P1|Participant Flow|Sequence A|Aclidinium 400 μg - Placebo
21732|NCT02153489|O2|Outcome|Placebo|Placebo BID
21733|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21734|NCT02153489|O2|Outcome|Placebo|Placebo BID
21735|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21736|NCT02153489|O2|Outcome|Placebo|Placebo BID
21737|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21738|NCT02153489|O2|Outcome|Placebo|Placebo BID
21739|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21740|NCT02153489|O2|Outcome|Placebo|Placebo BID
21741|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21742|NCT02153489|O2|Outcome|Placebo|Placebo BID
21743|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21744|NCT02153489|O2|Outcome|Placebo|Placebo BID
21745|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21746|NCT02153489|O2|Outcome|Placebo|Placebo BID
21747|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21748|NCT02153489|O2|Outcome|Placebo|Placebo BID
21749|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21750|NCT02153489|O2|Outcome|Placebo|Placebo BID
21751|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21752|NCT02153489|O2|Outcome|Placebo|Placebo BID
21753|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21754|NCT02153489|O2|Outcome|Placebo|Placebo BID
21755|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21756|NCT02153489|O2|Outcome|Placebo|Placebo BID
21757|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21758|NCT02153489|O2|Outcome|Placebo|Placebo BID
21759|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21760|NCT02153489|O2|Outcome|Placebo|Placebo BID
21761|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21762|NCT02153489|O2|Outcome|Placebo|Placebo BID
21763|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21764|NCT02153489|O2|Outcome|Placebo|Placebo BID
21765|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
21766|NCT02153489|E2|Reported Event|Placebo|Placebo BID
21767|NCT02153489|E1|Reported Event|Aclidinium|Aclidinium 400 μg BID
21768|NCT02153398|B6|Baseline|Total|Total of all reporting groups
21769|NCT02153398|B5|Baseline|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21770|NCT02153398|B4|Baseline|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21771|NCT02153398|B3|Baseline|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21772|NCT02153398|B2|Baseline|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21773|NCT02153398|B1|Baseline|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21774|NCT02153398|P5|Participant Flow|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21775|NCT02153398|P4|Participant Flow|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
22091|NCT02151994|E4|Reported Event|50 mg (SAD)|SAD period
21781|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21782|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21783|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21784|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21785|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21786|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21787|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21788|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21789|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21790|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21791|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21792|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21793|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21794|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21795|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21796|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21797|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21798|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21799|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21800|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21801|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21802|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21803|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21804|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21805|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21806|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21807|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21808|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21809|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21810|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21811|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21812|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21813|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21814|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21815|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21816|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21817|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21818|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21819|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21820|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21821|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21822|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21823|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21824|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21825|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21826|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21827|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21828|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21829|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21830|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21831|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21832|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21833|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21834|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21835|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21836|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21837|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21838|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21839|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21840|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21841|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21842|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21843|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21844|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21845|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
22092|NCT02151994|E3|Reported Event|25 mg (SAD)|SAD period
21846|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21847|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21848|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21849|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21850|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21851|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21852|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21853|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21854|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21855|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21856|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21857|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21858|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21859|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21860|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21861|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21862|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21863|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21864|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21865|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21866|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21867|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21868|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21869|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21870|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21871|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21872|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21873|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21874|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21875|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21876|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21877|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21878|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21879|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21880|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21881|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21882|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21883|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21884|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21885|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21886|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21887|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21888|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21889|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21890|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21891|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21892|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21893|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21894|NCT02153398|E5|Reported Event|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
21895|NCT02153398|E4|Reported Event|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
21896|NCT02153398|E3|Reported Event|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
21897|NCT02153398|E2|Reported Event|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
21898|NCT02153398|E1|Reported Event|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
21899|NCT02153099|B8|Baseline|Total|Total of all reporting groups
21900|NCT02153099|B7|Baseline|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21901|NCT02153099|B6|Baseline|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21902|NCT02153099|B5|Baseline|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21903|NCT02153099|B4|Baseline|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21904|NCT02153099|B3|Baseline|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21905|NCT02153099|B2|Baseline|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21906|NCT02153099|B1|Baseline|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21907|NCT02153099|P7|Participant Flow|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21908|NCT02153099|P6|Participant Flow|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21909|NCT02153099|P5|Participant Flow|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21910|NCT02153099|P4|Participant Flow|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21911|NCT02153099|P3|Participant Flow|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21912|NCT02153099|P2|Participant Flow|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21913|NCT02153099|P1|Participant Flow|Cohort 4: TAK-058 5 mg|TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1.
21914|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21915|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21916|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21917|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21918|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21919|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21920|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21921|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21922|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21923|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21924|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21925|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21926|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21927|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21928|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21929|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21930|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21931|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21932|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21933|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21934|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21935|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21936|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21937|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21938|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21939|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21940|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21941|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21942|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21943|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21944|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21945|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21946|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21947|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21948|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21949|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21950|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21951|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21952|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21953|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21954|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21955|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21956|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21957|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21958|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21959|NCT02153099|E7|Reported Event|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
21960|NCT02153099|E6|Reported Event|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
21961|NCT02153099|E5|Reported Event|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
21962|NCT02153099|E4|Reported Event|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
21963|NCT02153099|E3|Reported Event|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
21964|NCT02153099|E2|Reported Event|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
21965|NCT02153099|E1|Reported Event|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
21966|NCT02153086|B1|Baseline|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21967|NCT02153086|P1|Participant Flow|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21968|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21969|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21970|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21971|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21972|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21973|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21974|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21975|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21976|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21977|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21978|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21979|NCT02153086|E1|Reported Event|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
21980|NCT02152605|B3|Baseline|Total|Total of all reporting groups
21981|NCT02152605|B2|Baseline|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21982|NCT02152605|B1|Baseline|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21983|NCT02152605|P2|Participant Flow|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21984|NCT02152605|P1|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21985|NCT02152605|O2|Outcome|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21986|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21987|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21988|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21989|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21990|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21991|NCT02152605|E2|Reported Event|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
22093|NCT02151994|E2|Reported Event|5 mg (SAD)|SAD period
22094|NCT02151994|E1|Reported Event|Placebo (SAD)|SAD period
22253|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
21992|NCT02152605|E1|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
21993|NCT02152566|B1|Baseline|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
21994|NCT02152566|P1|Participant Flow|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
21995|NCT02152566|O1|Outcome|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
21996|NCT02152566|E1|Reported Event|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
21997|NCT02152371|B3|Baseline|Total|Total of all reporting groups
21998|NCT02152371|B2|Baseline|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
21999|NCT02152371|B1|Baseline|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
22000|NCT02152371|P2|Participant Flow|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
22001|NCT02152371|P1|Participant Flow|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
22002|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22003|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22004|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22005|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22006|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22007|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22008|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22009|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22010|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22095|NCT02151786|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22254|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
22011|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22012|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22013|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22014|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22015|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22016|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22017|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22018|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22019|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22020|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22021|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22022|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22023|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22024|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22025|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22026|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22027|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22028|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22029|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22030|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22096|NCT02151786|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22097|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22031|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22032|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22033|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22034|NCT02152371|E2|Reported Event|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22035|NCT02152371|E1|Reported Event|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
22036|NCT02152007|B1|Baseline|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
22037|NCT02152007|P1|Participant Flow|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
22038|NCT02152007|O2|Outcome|Placebo Cream (Vehicle Control)|Placebo Cream (Vehicle Control)
22039|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
22040|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
22041|NCT02152007|E1|Reported Event|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
22042|NCT02151994|B4|Baseline|Total|Total of all reporting groups
22043|NCT02151994|B3|Baseline|Food Interaction (Food Effect, FE) Analysis|This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.
22044|NCT02151994|B2|Baseline|Multiple Ascending Dose (MAD)|This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
22045|NCT02151994|B1|Baseline|Single Ascending Dose (SAD)|This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomised design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
22046|NCT02151994|P13|Participant Flow|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
22047|NCT02151994|P12|Participant Flow|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
22048|NCT02151994|P11|Participant Flow|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
22098|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22099|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22049|NCT02151994|P10|Participant Flow|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
22050|NCT02151994|P9|Participant Flow|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg.
22051|NCT02151994|P8|Participant Flow|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
22052|NCT02151994|P7|Participant Flow|400 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
22053|NCT02151994|P6|Participant Flow|200 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
22054|NCT02151994|P5|Participant Flow|100 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
22055|NCT02151994|P4|Participant Flow|50 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
22056|NCT02151994|P3|Participant Flow|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
22057|NCT02151994|P2|Participant Flow|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
22058|NCT02151994|P1|Participant Flow|Placebo|Placebo : visually matching active medication
22059|NCT02151994|O2|Outcome|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets
22060|NCT02151994|O1|Outcome|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets
22061|NCT02151994|O6|Outcome|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22062|NCT02151994|O5|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22063|NCT02151994|O4|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22064|NCT02151994|O3|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22065|NCT02151994|O2|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22066|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
22067|NCT02151994|O10|Outcome|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22068|NCT02151994|O9|Outcome|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22069|NCT02151994|O8|Outcome|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22070|NCT02151994|O7|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22071|NCT02151994|O6|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22072|NCT02151994|O5|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22073|NCT02151994|O4|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22074|NCT02151994|O3|Outcome|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22075|NCT02151994|O2|Outcome|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
22076|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
22077|NCT02151994|E18|Reported Event|1200 mg (MAD Period)|MAD period
22078|NCT02151994|E17|Reported Event|400 mg (MAD Period)|MAD period
22079|NCT02151994|E16|Reported Event|200 mg (MAD Period)|MAD period
22080|NCT02151994|E15|Reported Event|100 mg (MAD Period)|MAD period
22081|NCT02151994|E14|Reported Event|50 mg (MAD Period)|MAD period
22082|NCT02151994|E13|Reported Event|Placebo (MAD Period)|MAD period
22083|NCT02151994|E12|Reported Event|400 mg Fed (FE Period)|FE period
22084|NCT02151994|E11|Reported Event|400 mg Fasted (FE Period)|FE period
22085|NCT02151994|E10|Reported Event|2400 mg (SAD)|SAD period
22086|NCT02151994|E9|Reported Event|1600 mg (SAD)|SAD period
22087|NCT02151994|E8|Reported Event|800 mg (SAD)|SAD period
22088|NCT02151994|E7|Reported Event|400 mg (SAD)|SAD period
22089|NCT02151994|E6|Reported Event|200 mg (SAD)|SAD period
22090|NCT02151994|E5|Reported Event|100 mg (SAD)|SAD period
22100|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22101|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22102|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22103|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22104|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22105|NCT02151786|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
22106|NCT02151773|B1|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
22107|NCT02151773|P1|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed.
22108|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
22109|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
22110|NCT02151773|E1|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
22111|NCT02151058|B4|Baseline|Total|Total of all reporting groups
22112|NCT02151058|B3|Baseline|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22113|NCT02151058|B2|Baseline|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22114|NCT02151058|B1|Baseline|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22115|NCT02151058|P3|Participant Flow|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22116|NCT02151058|P2|Participant Flow|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22117|NCT02151058|P1|Participant Flow|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22118|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22119|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22120|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22121|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22122|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22123|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22124|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22125|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22126|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22127|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22128|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22129|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22130|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22131|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22132|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22133|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22134|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22135|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22136|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22137|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22138|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22255|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
22139|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22140|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22141|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22142|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22143|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22144|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22145|NCT02151058|E3|Reported Event|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
22146|NCT02151058|E2|Reported Event|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
22147|NCT02151058|E1|Reported Event|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
22148|NCT02150954|B3|Baseline|Total|Total of all reporting groups
22149|NCT02150954|B2|Baseline|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22150|NCT02150954|B1|Baseline|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22151|NCT02150954|P2|Participant Flow|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22152|NCT02150954|P1|Participant Flow|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22153|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22154|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22155|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22156|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22157|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22158|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22159|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22160|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22161|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22162|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22163|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22164|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22165|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22166|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22167|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22168|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22169|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22170|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22171|NCT02150954|E2|Reported Event|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
22172|NCT02150954|E1|Reported Event|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
22173|NCT02150499|B3|Baseline|Total|Total of all reporting groups
22256|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
22174|NCT02150499|B2|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22175|NCT02150499|B1|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22176|NCT02150499|P2|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22177|NCT02150499|P1|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22178|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22179|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22180|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22181|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22182|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22183|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22184|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22185|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22186|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22187|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22188|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22189|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22190|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22191|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22250|NCT02149875|P3|Participant Flow|Placebo|"Intravenous infusion of 100 ml saline intravenous q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
22257|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
22192|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22193|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22194|NCT02150499|E2|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
22195|NCT02150499|E1|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
22196|NCT02150460|B3|Baseline|Total|Total of all reporting groups
22197|NCT02150460|B2|Baseline|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
22198|NCT02150460|B1|Baseline|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
22199|NCT02150460|P2|Participant Flow|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
22200|NCT02150460|P1|Participant Flow|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
22201|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22202|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22203|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22204|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22205|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22206|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22207|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22208|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22209|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22210|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22211|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22212|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22213|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22214|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22215|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22216|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22217|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22218|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22219|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
22220|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
22221|NCT02150460|E2|Reported Event|Group 2|Two-site peribulbar injection
22222|NCT02150460|E1|Reported Event|Group 1|One-site peribulbar injection
22223|NCT02150213|B1|Baseline|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
22224|NCT02150213|P1|Participant Flow|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
22225|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
22226|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
22227|NCT02150213|E1|Reported Event|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
22228|NCT02150109|B1|Baseline|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
22251|NCT02149875|P2|Participant Flow|Cerebrolysin|"Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
22252|NCT02149875|P1|Participant Flow|Dl-3-n-butylphthalide|"Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
22229|NCT02150109|P1|Participant Flow|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
22230|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
22231|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22232|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22233|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22234|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22235|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
22236|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22237|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma."
22238|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
22239|NCT02150109|E1|Reported Event|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
22240|NCT02150044|B1|Baseline|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22241|NCT02150044|P1|Participant Flow|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22242|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22243|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22244|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22245|NCT02150044|E1|Reported Event|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
22246|NCT02149875|B4|Baseline|Total|Total of all reporting groups
22247|NCT02149875|B3|Baseline|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
22248|NCT02149875|B2|Baseline|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
22249|NCT02149875|B1|Baseline|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
22258|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
22259|NCT02149875|E3|Reported Event|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
22260|NCT02149875|E2|Reported Event|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
22261|NCT02149875|E1|Reported Event|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
22262|NCT02149342|B1|Baseline|Hexylaminolaevulinate and Methylaminoalevulinate Cream|0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
22263|NCT02149342|P1|Participant Flow|Hexylaminolaevulinate and Methylaminoalevulinate Creams|"0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma)~HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design"
22264|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
22265|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
22266|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
22267|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
22268|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
22269|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
22270|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
22271|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream"
22272|NCT02149342|E2|Reported Event|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
22273|NCT02149342|E1|Reported Event|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
22274|NCT02149303|B1|Baseline|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22275|NCT02149303|P1|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22276|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22277|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22278|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22279|NCT02149303|E1|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
22280|NCT02148107|B4|Baseline|Total|Total of all reporting groups
22281|NCT02148107|B3|Baseline|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
22282|NCT02148107|B2|Baseline|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22283|NCT02148107|B1|Baseline|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22284|NCT02148107|P3|Participant Flow|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
22285|NCT02148107|P2|Participant Flow|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22286|NCT02148107|P1|Participant Flow|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22364|NCT02147288|P3|Participant Flow|Breast Recon With Acellular Dermal Matrix (ADM) on NPWT|
22287|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22288|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22289|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22290|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22291|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22292|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22293|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22294|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22295|NCT02148107|O3|Outcome|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
22296|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22297|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22298|NCT02148107|E3|Reported Event|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
22299|NCT02148107|E2|Reported Event|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
22300|NCT02148107|E1|Reported Event|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
22301|NCT02147691|B3|Baseline|Total|Total of all reporting groups
22302|NCT02147691|B2|Baseline|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
22303|NCT02147691|B1|Baseline|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22304|NCT02147691|P2|Participant Flow|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
22305|NCT02147691|P1|Participant Flow|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22306|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22307|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22308|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22309|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22310|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22311|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22312|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22313|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22314|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22315|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22316|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22317|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22318|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22319|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22320|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22321|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22322|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22323|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22324|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22325|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22326|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22327|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22328|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22329|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22330|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22331|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22332|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22333|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22334|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22335|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22336|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22337|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22338|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22339|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22340|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22341|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22342|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22343|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22344|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22345|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22346|NCT02147691|E2|Reported Event|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
22347|NCT02147691|E1|Reported Event|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
22348|NCT02147561|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22349|NCT02147561|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22350|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22351|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22352|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22353|NCT02147561|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
22354|NCT02147288|B3|Baseline|Total|Total of all reporting groups
22355|NCT02147288|B2|Baseline|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
22356|NCT02147288|B1|Baseline|Panniculectomy on JP Drains|Standard of Care
22357|NCT02147288|P10|Participant Flow|Ventral Hernia Repair (VHR) on JP Drains|
22358|NCT02147288|P9|Participant Flow|Ventral Hernia Repair (VHR) on NPWT|
22359|NCT02147288|P8|Participant Flow|Abdominoplasty on JP Drains|
22360|NCT02147288|P7|Participant Flow|Abdominoplasty on NPWT|
22361|NCT02147288|P6|Participant Flow|Lipoabdominoplasty on JP Drains|
22362|NCT02147288|P5|Participant Flow|Lipoabdominoplasty on NPWT|
22363|NCT02147288|P4|Participant Flow|Breast Recon With ADM on Jackson-Pratt (JP) Drains|
22365|NCT02147288|P2|Participant Flow|Panniculectomy on Negative Pressure Wound Therapy (NPWT)|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
22366|NCT02147288|P1|Participant Flow|Panniculectomy on Jackson Pratt (JP) Drains|Standard of Care
22367|NCT02147288|O2|Outcome|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
22368|NCT02147288|O1|Outcome|Panniculectomy on JP Drains|Standard of Care
22369|NCT02147288|E2|Reported Event|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
22370|NCT02147288|E1|Reported Event|Panniculectomy on JP Drains|Standard of Care
22371|NCT02147093|B3|Baseline|Total|Total of all reporting groups
22372|NCT02147093|B2|Baseline|Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)|All subjects that were randomized to sequence and were dispensed a study lens.
22373|NCT02147093|B1|Baseline|Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)|All subjects that were randomized to sequence and were dispensed a study lens.
22374|NCT02147093|P2|Participant Flow|Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)|Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
22375|NCT02147093|P1|Participant Flow|Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)|Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
22376|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
22377|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
22378|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
22379|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
22380|NCT02147093|E2|Reported Event|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
22381|NCT02147093|E1|Reported Event|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
22382|NCT02146599|B1|Baseline|Pseudophakic|Administration of patient self assessment
22383|NCT02146599|P1|Participant Flow|Pseudophakic|Administration of patient self assessment
22384|NCT02146599|O1|Outcome|Pseudophakic|Administration of patient self assessment
22385|NCT02146599|E1|Reported Event|Pseudophakic|Administration of patient self assessment
22386|NCT02146482|B3|Baseline|Total|Total of all reporting groups
22387|NCT02146482|B2|Baseline|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
22388|NCT02146482|B1|Baseline|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
22389|NCT02146482|P2|Participant Flow|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
22390|NCT02146482|P1|Participant Flow|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
22391|NCT02146482|O2|Outcome|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
22392|NCT02146482|O1|Outcome|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
22393|NCT02146482|E2|Reported Event|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
22394|NCT02146482|E1|Reported Event|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
22395|NCT02146352|B1|Baseline|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22396|NCT02146352|P1|Participant Flow|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22397|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22398|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22399|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22400|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22401|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22402|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22403|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22404|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22405|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22406|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22407|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22408|NCT02146352|E1|Reported Event|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
22409|NCT02146105|B1|Baseline|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
22410|NCT02146105|P1|Participant Flow|Yoga Intervention|Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
22411|NCT02146105|O1|Outcome|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
22412|NCT02146105|E1|Reported Event|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
22413|NCT02146001|B3|Baseline|Total|Total of all reporting groups
22414|NCT02146001|B2|Baseline|Sit Less|Targeting 1 hour less of sedentary time per day
22415|NCT02146001|B1|Baseline|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22416|NCT02146001|P2|Participant Flow|Sit Less|Targeting 1 hour less of sedentary time per day
22417|NCT02146001|P1|Participant Flow|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22418|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
22419|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22420|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
22421|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22422|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
22423|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22424|NCT02146001|E2|Reported Event|Sit Less|Targeting 1 hour less of sedentary time per day
22425|NCT02146001|E1|Reported Event|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
22426|NCT02145754|B1|Baseline|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
22427|NCT02145754|P1|Participant Flow|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media~MKP media versus BSK-H media"
22428|NCT02145754|O1|Outcome|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
22429|NCT02145754|E1|Reported Event|MKP Media Versus BSK-h Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
22430|NCT02145676|B4|Baseline|Total|Total of all reporting groups
22431|NCT02145676|B3|Baseline|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22432|NCT02145676|B2|Baseline|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22433|NCT02145676|B1|Baseline|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22434|NCT02145676|P3|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22435|NCT02145676|P2|Participant Flow|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22436|NCT02145676|P1|Participant Flow|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22437|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22438|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22439|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22440|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22441|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22442|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22443|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22444|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22445|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22446|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22447|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22448|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22449|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22450|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22451|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22452|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22453|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22454|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22455|NCT02145676|E3|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
22456|NCT02145676|E2|Reported Event|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
22457|NCT02145676|E1|Reported Event|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
22458|NCT02145299|B3|Baseline|Total|Total of all reporting groups
22459|NCT02145299|B2|Baseline|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22460|NCT02145299|B1|Baseline|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22461|NCT02145299|P2|Participant Flow|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22462|NCT02145299|P1|Participant Flow|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22551|NCT02144259|P2|Participant Flow|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22463|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22464|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22465|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22466|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22467|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22468|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22469|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22470|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22471|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22472|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22473|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22552|NCT02144259|P1|Participant Flow|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22553|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
22474|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22475|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22476|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22477|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22478|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22479|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22480|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22481|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22482|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22483|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22484|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22485|NCT02145299|E2|Reported Event|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
22486|NCT02145299|E1|Reported Event|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
22487|NCT02145156|B4|Baseline|Total|Total of all reporting groups
22488|NCT02145156|B3|Baseline|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22489|NCT02145156|B2|Baseline|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22490|NCT02145156|B1|Baseline|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22491|NCT02145156|P3|Participant Flow|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22492|NCT02145156|P2|Participant Flow|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22493|NCT02145156|P1|Participant Flow|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22494|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22495|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22496|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22497|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22498|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22554|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22633|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
22499|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22500|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22501|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22502|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22503|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22504|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22505|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22506|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22507|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22508|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22509|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22510|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22511|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22512|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
45506|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
22513|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22514|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22515|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22516|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22517|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22518|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22519|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22520|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22521|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22522|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22523|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22524|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22525|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22555|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22556|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
22591|NCT02143583|B1|Baseline|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
22526|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22527|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22528|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22529|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22530|NCT02145156|E3|Reported Event|Usual Care|"Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
22531|NCT02145156|E2|Reported Event|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
22532|NCT02145156|E1|Reported Event|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
22533|NCT02144337|B3|Baseline|Total|Total of all reporting groups
22534|NCT02144337|B2|Baseline|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
22535|NCT02144337|B1|Baseline|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
22536|NCT02144337|P2|Participant Flow|Control Group|Control group. Children in the Control group are asked to continue normal daily activities.
22537|NCT02144337|P1|Participant Flow|Intervention Group|6 week Steps To Active Kids (STAK) programme includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 – 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress.
22538|NCT02144337|O1|Outcome|Overall Study Group Sample|Intervention and control group combined
22539|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
22540|NCT02144337|O2|Outcome|Control Group|No intervention
22541|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
22542|NCT02144337|O2|Outcome|Control Group|No intervention
22543|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
22544|NCT02144337|E2|Reported Event|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
22545|NCT02144337|E1|Reported Event|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
22546|NCT02144259|B4|Baseline|Total|Total of all reporting groups
22547|NCT02144259|B3|Baseline|Control Group|Subjects selecting their own method of contraception or no contraception.
22548|NCT02144259|B2|Baseline|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22549|NCT02144259|B1|Baseline|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22550|NCT02144259|P3|Participant Flow|Control Group|Subjects selecting their own method of contraception or no contraception.
22590|NCT02143583|B2|Baseline|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
22557|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22558|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22559|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
22560|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22561|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22562|NCT02144259|E3|Reported Event|Control Group|Subjects selecting their own method of contraception or no contraception.
22563|NCT02144259|E2|Reported Event|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
22564|NCT02144259|E1|Reported Event|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
22565|NCT02144220|B1|Baseline|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22566|NCT02144220|P1|Participant Flow|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22567|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22568|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22569|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22570|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22571|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22572|NCT02144220|E1|Reported Event|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
22573|NCT02143947|B3|Baseline|Total|Total of all reporting groups
22574|NCT02143947|B2|Baseline|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22575|NCT02143947|B1|Baseline|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22576|NCT02143947|P2|Participant Flow|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22577|NCT02143947|P1|Participant Flow|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22578|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22579|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22580|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22581|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22582|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22583|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22584|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22585|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22586|NCT02143947|E2|Reported Event|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
22587|NCT02143947|E1|Reported Event|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
22588|NCT02143583|B4|Baseline|Total|Total of all reporting groups
22589|NCT02143583|B3|Baseline|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
22592|NCT02143583|P3|Participant Flow|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
22593|NCT02143583|P2|Participant Flow|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
22594|NCT02143583|P1|Participant Flow|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
22595|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
22596|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
22597|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
22598|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
22599|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
22600|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
22601|NCT02143583|E3|Reported Event|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
22602|NCT02143583|E2|Reported Event|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
22603|NCT02143583|E1|Reported Event|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
22604|NCT02142712|B4|Baseline|Total|Total of all reporting groups
22605|NCT02142712|B3|Baseline|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22606|NCT02142712|B2|Baseline|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22607|NCT02142712|B1|Baseline|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22608|NCT02142712|P4|Participant Flow|Dextromethorphan|Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care
22609|NCT02142712|P3|Participant Flow|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22610|NCT02142712|P2|Participant Flow|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22611|NCT02142712|P1|Participant Flow|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22612|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22613|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22614|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22615|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22616|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22617|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22618|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22619|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22620|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22621|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22622|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22623|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22624|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22625|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22626|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22627|NCT02142712|E3|Reported Event|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
22628|NCT02142712|E2|Reported Event|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
22629|NCT02142712|E1|Reported Event|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
22630|NCT02141867|B1|Baseline|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
22631|NCT02141867|P1|Participant Flow|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
22632|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
22634|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
22635|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
22636|NCT02141867|E1|Reported Event|Non Cardiac Surgery|Non cardiac surgery patients 16 years or older
22637|NCT02142361|B1|Baseline|Overall Study Group|All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
22638|NCT02142361|P3|Participant Flow|Methafilcon B/Enfilcon A|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22639|NCT02142361|P2|Participant Flow|Ocufilcon D/Enfilcon A|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22640|NCT02142361|P1|Participant Flow|Omafilcon A/Enfilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22641|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22642|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22643|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22644|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22645|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22646|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22647|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22648|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22649|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22650|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22651|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22652|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22653|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22654|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22655|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22656|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22657|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22658|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22659|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22660|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22661|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22662|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22663|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22664|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22665|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22666|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22667|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22668|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22669|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22670|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22671|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22672|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22673|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22674|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22675|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22676|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22677|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22678|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22679|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22680|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22681|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22682|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22683|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22684|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
22685|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
22686|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at 1 week.
22687|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22688|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22689|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22690|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22691|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22692|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22693|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22694|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22695|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22696|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22697|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22698|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22699|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22700|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22701|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22702|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22703|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22704|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22705|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22706|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22707|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22708|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22709|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22710|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22711|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22712|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22713|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22714|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22715|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22716|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22717|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22718|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22719|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22720|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22721|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22722|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22723|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22724|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22725|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22726|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22727|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22728|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22729|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22730|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22731|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22732|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22733|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22734|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
22735|NCT02142361|E3|Reported Event|Methafilcon B|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
22736|NCT02142361|E2|Reported Event|Ocufilcon D|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
22737|NCT02142361|E1|Reported Event|Omafilcon A|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
22738|NCT02142153|B11|Baseline|Total|Total of all reporting groups
22739|NCT02142153|B10|Baseline|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22740|NCT02142153|B9|Baseline|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22741|NCT02142153|B8|Baseline|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22742|NCT02142153|B7|Baseline|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22743|NCT02142153|B6|Baseline|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22744|NCT02142153|B5|Baseline|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22745|NCT02142153|B4|Baseline|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22746|NCT02142153|B3|Baseline|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22747|NCT02142153|B2|Baseline|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22748|NCT02142153|B1|Baseline|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22749|NCT02142153|P10|Participant Flow|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22750|NCT02142153|P9|Participant Flow|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22751|NCT02142153|P8|Participant Flow|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22752|NCT02142153|P7|Participant Flow|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22753|NCT02142153|P6|Participant Flow|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22754|NCT02142153|P5|Participant Flow|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22755|NCT02142153|P4|Participant Flow|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22756|NCT02142153|P3|Participant Flow|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22757|NCT02142153|P2|Participant Flow|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22758|NCT02142153|P1|Participant Flow|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22759|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
22760|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
22761|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
22762|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
22763|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
22764|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
22765|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
22766|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
22767|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically significant safety lab and ECG abnormalities No clinically significant findings"
22768|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
22769|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22770|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22771|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22772|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22773|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22774|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22775|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22776|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22777|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22778|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22779|NCT02142153|E10|Reported Event|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22780|NCT02142153|E9|Reported Event|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22781|NCT02142153|E8|Reported Event|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22884|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22782|NCT02142153|E7|Reported Event|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22783|NCT02142153|E6|Reported Event|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22784|NCT02142153|E5|Reported Event|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22785|NCT02142153|E4|Reported Event|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22786|NCT02142153|E3|Reported Event|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22787|NCT02142153|E2|Reported Event|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
22788|NCT02142153|E1|Reported Event|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
22789|NCT02141997|B5|Baseline|Total|Total of all reporting groups
22790|NCT02141997|B4|Baseline|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22791|NCT02141997|B3|Baseline|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22792|NCT02141997|B2|Baseline|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22793|NCT02141997|B1|Baseline|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22794|NCT02141997|P4|Participant Flow|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22795|NCT02141997|P3|Participant Flow|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22796|NCT02141997|P2|Participant Flow|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22797|NCT02141997|P1|Participant Flow|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22798|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22799|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22800|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22801|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22802|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22803|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22804|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22805|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22806|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22807|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22808|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22809|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22810|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22811|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22812|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22813|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22814|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22815|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22816|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22817|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22818|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22819|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22820|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22821|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22822|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22823|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22824|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22825|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22826|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22827|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22828|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22829|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22830|NCT02141997|E4|Reported Event|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
22831|NCT02141997|E3|Reported Event|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
22832|NCT02141997|E2|Reported Event|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
22833|NCT02141997|E1|Reported Event|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
22834|NCT02141633|B3|Baseline|Total|Total of all reporting groups
22835|NCT02141633|B2|Baseline|Non-smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22885|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22836|NCT02141633|B1|Baseline|Smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22837|NCT02141633|P2|Participant Flow|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22838|NCT02141633|P1|Participant Flow|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22839|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22840|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22841|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22842|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
22843|NCT02141633|E2|Reported Event|Non-smokers|No AE or SAE had occurred
22844|NCT02141633|E1|Reported Event|Smokers|No AE or SAE had occurred
22845|NCT02141620|B1|Baseline|All Study Participants|All subjects who completed the study.
22846|NCT02141620|P2|Participant Flow|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
22847|NCT02141620|P1|Participant Flow|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
22848|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22849|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22850|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22851|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22852|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22853|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22854|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22855|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22856|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22857|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22858|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22859|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22860|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22861|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22862|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22863|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22864|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22865|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22866|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22867|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22868|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22869|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22870|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22871|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22872|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22873|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22874|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22875|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22876|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22877|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22878|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22879|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22880|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22881|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22882|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22883|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22886|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22887|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22888|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22889|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22890|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22891|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22892|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22893|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22894|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22895|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22896|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22897|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22898|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22899|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22900|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
22901|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
22902|NCT02141620|E2|Reported Event|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
22903|NCT02141620|E1|Reported Event|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
22904|NCT02141516|B4|Baseline|Total|Total of all reporting groups
22905|NCT02141516|B3|Baseline|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22906|NCT02141516|B2|Baseline|Asplenia|Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22907|NCT02141516|B1|Baseline|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22908|NCT02141516|P3|Participant Flow|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22909|NCT02141516|P2|Participant Flow|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22910|NCT02141516|P1|Participant Flow|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22911|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22912|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22913|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22914|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22915|NCT02141516|O5|Outcome|Total|Total of subjects
22916|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22917|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22918|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22919|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22920|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22921|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22922|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22923|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22924|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22925|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22926|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22927|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22928|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22929|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22930|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22931|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22932|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22933|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
45507|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
22934|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22935|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22936|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22937|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22938|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22939|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22940|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22941|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22942|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22943|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22944|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22945|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22946|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22947|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22948|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22949|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22950|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22951|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22952|NCT02141516|E5|Reported Event|Total|Total number of Subjects
22953|NCT02141516|E4|Reported Event|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
22954|NCT02141516|E3|Reported Event|CompDef + Asplenia|Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22955|NCT02141516|E2|Reported Event|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
22956|NCT02141516|E1|Reported Event|CompDef|Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
22957|NCT02141217|B3|Baseline|Total|Total of all reporting groups
22958|NCT02141217|B2|Baseline|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22959|NCT02141217|B1|Baseline|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22960|NCT02141217|P2|Participant Flow|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22961|NCT02141217|P1|Participant Flow|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22962|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22963|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22964|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22965|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22966|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22967|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22968|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22969|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22970|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants randomized to clindamycin 150 mg.
22971|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
22972|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22973|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22974|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22975|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22976|NCT02141217|E2|Reported Event|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22977|NCT02141217|E1|Reported Event|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
22978|NCT02140957|B3|Baseline|Total|Total of all reporting groups
22979|NCT02140957|B2|Baseline|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22980|NCT02140957|B1|Baseline|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22981|NCT02140957|P2|Participant Flow|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22982|NCT02140957|P1|Participant Flow|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22983|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22984|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
23025|NCT02140645|B2|Baseline|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
22985|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22986|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22987|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22988|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22989|NCT02140957|E2|Reported Event|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22990|NCT02140957|E1|Reported Event|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
22991|NCT02140788|B1|Baseline|All Subjects Who Consented|All subjects who signed a consent form
22992|NCT02140788|P4|Participant Flow|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
22993|NCT02140788|P3|Participant Flow|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
22994|NCT02140788|P2|Participant Flow|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
22995|NCT02140788|P1|Participant Flow|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
22996|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
22997|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
22998|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
22999|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23000|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
23001|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
23002|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
23003|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23004|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
23005|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
23006|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
23007|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23008|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
23009|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
23010|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
23011|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23012|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
23013|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
23014|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
23015|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23016|NCT02140788|E4|Reported Event|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
23017|NCT02140788|E3|Reported Event|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
23018|NCT02140788|E2|Reported Event|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
23019|NCT02140788|E1|Reported Event|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
23020|NCT02140645|B7|Baseline|Total|Total of all reporting groups
23021|NCT02140645|B6|Baseline|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23022|NCT02140645|B5|Baseline|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23023|NCT02140645|B4|Baseline|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23024|NCT02140645|B3|Baseline|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23026|NCT02140645|B1|Baseline|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23027|NCT02140645|P6|Participant Flow|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23028|NCT02140645|P5|Participant Flow|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23029|NCT02140645|P4|Participant Flow|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23030|NCT02140645|P3|Participant Flow|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23031|NCT02140645|P2|Participant Flow|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23032|NCT02140645|P1|Participant Flow|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23033|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23034|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23035|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23036|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23037|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23038|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23039|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23040|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23041|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23042|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23043|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23044|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23045|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23046|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23047|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23048|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23049|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23050|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23051|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23052|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23053|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23054|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23055|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23230|NCT02139943|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
23056|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23057|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23058|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23059|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23060|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23061|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23062|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23063|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23064|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23065|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23066|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23067|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23068|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23069|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23070|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23071|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23072|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23073|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23074|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23075|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23076|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23077|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23078|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23079|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23080|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23081|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23082|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23083|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23084|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23085|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23231|NCT02139943|P1|Participant Flow|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
23086|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23087|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23088|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23089|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23090|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23091|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23092|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23093|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23094|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23095|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23096|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23097|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23098|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23099|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23100|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23101|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23102|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23103|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23104|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23105|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23106|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23107|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23108|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23109|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23110|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23111|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
23112|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
23113|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
23114|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
23115|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23232|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
23116|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
23117|NCT02140645|E1|Reported Event|MarketScan|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
23118|NCT02140372|B1|Baseline|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23119|NCT02140372|P1|Participant Flow|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23120|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23121|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23122|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23123|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23124|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23125|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23126|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23127|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23128|NCT02140372|E1|Reported Event|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
23129|NCT02140164|B1|Baseline|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23130|NCT02140164|P1|Participant Flow|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23131|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23132|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23133|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23134|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23135|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23136|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23137|NCT02140164|E1|Reported Event|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
23138|NCT02140060|B7|Baseline|Total|Total of all reporting groups
23139|NCT02140060|B6|Baseline|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23140|NCT02140060|B5|Baseline|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
23141|NCT02140060|B4|Baseline|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23142|NCT02140060|B3|Baseline|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23143|NCT02140060|B2|Baseline|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23144|NCT02140060|B1|Baseline|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23145|NCT02140060|P6|Participant Flow|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23146|NCT02140060|P5|Participant Flow|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
23147|NCT02140060|P4|Participant Flow|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23148|NCT02140060|P3|Participant Flow|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
24572|NCT02121860|B3|Baseline|Child-Pugh Class C|Severe Hepatic Impairment
23149|NCT02140060|P2|Participant Flow|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23150|NCT02140060|P1|Participant Flow|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23151|NCT02140060|O6|Outcome|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23152|NCT02140060|O5|Outcome|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
23153|NCT02140060|O4|Outcome|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23154|NCT02140060|O3|Outcome|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23155|NCT02140060|O2|Outcome|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23156|NCT02140060|O1|Outcome|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23157|NCT02140060|E7|Reported Event|Pre-treatment|All subjects who signed an informed consent to participate in the study
23158|NCT02140060|E6|Reported Event|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23159|NCT02140060|E5|Reported Event|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
23160|NCT02140060|E4|Reported Event|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23161|NCT02140060|E3|Reported Event|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23162|NCT02140060|E2|Reported Event|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23163|NCT02140060|E1|Reported Event|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
23164|NCT02139982|B11|Baseline|Total|Total of all reporting groups
23165|NCT02139982|B10|Baseline|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23166|NCT02139982|B9|Baseline|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23167|NCT02139982|B8|Baseline|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23168|NCT02139982|B7|Baseline|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23169|NCT02139982|B6|Baseline|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23170|NCT02139982|B5|Baseline|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23171|NCT02139982|B4|Baseline|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23172|NCT02139982|B3|Baseline|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23173|NCT02139982|B2|Baseline|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23174|NCT02139982|B1|Baseline|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23175|NCT02139982|P10|Participant Flow|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23176|NCT02139982|P9|Participant Flow|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23177|NCT02139982|P8|Participant Flow|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23178|NCT02139982|P7|Participant Flow|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23179|NCT02139982|P6|Participant Flow|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23180|NCT02139982|P5|Participant Flow|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23181|NCT02139982|P4|Participant Flow|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23182|NCT02139982|P3|Participant Flow|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23183|NCT02139982|P2|Participant Flow|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23184|NCT02139982|P1|Participant Flow|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23185|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
24573|NCT02121860|B2|Baseline|Child-Pugh Class B|Moderate Hepatic Impairment
23186|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23187|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23188|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23189|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23190|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23191|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23192|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23193|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23194|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23195|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23196|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23197|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23198|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23199|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23200|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23201|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23202|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23203|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23204|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23205|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23206|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23207|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23208|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23209|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23210|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23211|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23212|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23213|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23214|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23215|NCT02139982|E10|Reported Event|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
23216|NCT02139982|E9|Reported Event|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
23217|NCT02139982|E8|Reported Event|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
23218|NCT02139982|E7|Reported Event|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
23219|NCT02139982|E6|Reported Event|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
23220|NCT02139982|E5|Reported Event|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
23221|NCT02139982|E4|Reported Event|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23222|NCT02139982|E3|Reported Event|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23223|NCT02139982|E2|Reported Event|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23224|NCT02139982|E1|Reported Event|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
23225|NCT02139943|B4|Baseline|Total|Total of all reporting groups
23226|NCT02139943|B3|Baseline|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
23227|NCT02139943|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
23228|NCT02139943|B1|Baseline|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
23229|NCT02139943|P3|Participant Flow|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
23233|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
23234|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
23235|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
23236|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
23237|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
23238|NCT02139943|E3|Reported Event|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
23239|NCT02139943|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
23240|NCT02139943|E1|Reported Event|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
23241|NCT02139878|B1|Baseline|Entire Study Population|Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
23242|NCT02139878|P2|Participant Flow|Placebo First, Then Wild Blueberry Juice|240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
23243|NCT02139878|P1|Participant Flow|Wild Blueberry Juice First, Then Placebo|240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)
23244|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
23245|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
23246|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
23247|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
23248|NCT02139878|E2|Reported Event|Placebo|240 ml Placebo beverage daily in either the first intervention period or second intervention period
23249|NCT02139878|E1|Reported Event|Wild Blueberry Juice|240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period
23250|NCT02139228|B3|Baseline|Total|Total of all reporting groups
23251|NCT02139228|B2|Baseline|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23252|NCT02139228|B1|Baseline|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23253|NCT02139228|P2|Participant Flow|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23254|NCT02139228|P1|Participant Flow|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23255|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23256|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23257|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23258|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23259|NCT02139228|E2|Reported Event|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23260|NCT02139228|E1|Reported Event|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
23261|NCT02139046|B6|Baseline|Total|Total of all reporting groups
23262|NCT02139046|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23263|NCT02139046|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23327|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23370|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23264|NCT02139046|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23265|NCT02139046|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23266|NCT02139046|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23267|NCT02139046|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23268|NCT02139046|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23269|NCT02139046|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23270|NCT02139046|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23271|NCT02139046|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23272|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23273|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23274|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23275|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23276|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23277|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23278|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23279|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23280|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23281|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23282|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23283|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23284|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23285|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23286|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23287|NCT02139046|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23288|NCT02139046|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23289|NCT02139046|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23290|NCT02139046|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23291|NCT02139046|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
23292|NCT02138747|B5|Baseline|Total|Total of all reporting groups
23293|NCT02138747|B4|Baseline|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
23294|NCT02138747|B3|Baseline|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23295|NCT02138747|B2|Baseline|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23296|NCT02138747|B1|Baseline|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23297|NCT02138747|P4|Participant Flow|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
23298|NCT02138747|P3|Participant Flow|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23299|NCT02138747|P2|Participant Flow|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23326|NCT02138747|O1|Outcome|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23300|NCT02138747|P1|Participant Flow|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23301|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23302|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23303|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23304|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23305|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23306|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23307|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23308|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23309|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23310|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23311|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23312|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23313|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23314|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23315|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23316|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23317|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23318|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23319|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23320|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23321|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23322|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23323|NCT02138747|O4|Outcome|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
23324|NCT02138747|O3|Outcome|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23325|NCT02138747|O2|Outcome|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
23328|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23329|NCT02138747|E2|Reported Event|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
23330|NCT02138747|E1|Reported Event|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
23331|NCT02138461|B3|Baseline|Total|Total of all reporting groups
23332|NCT02138461|B2|Baseline|Latanoprost Group|These patients take latanoprost topically for glaucoma.
23333|NCT02138461|B1|Baseline|Bimatoprost|These patients take bimatoprost topically for glaucoma.
23334|NCT02138461|P2|Participant Flow|Latanoprost Group|These patients take latanoprost topically for glaucoma.
23335|NCT02138461|P1|Participant Flow|Bimatoprost|These patients take bimatoprost topically for glaucoma.
23336|NCT02138461|O2|Outcome|Latanoprost Group|These patients take latanoprost topically for glaucoma.
23337|NCT02138461|O1|Outcome|Bimatoprost|These patients take bimatoprost topically for glaucoma.
23338|NCT02138461|E2|Reported Event|Latanoprost Group|These patients take latanoprost topically for glaucoma.
23339|NCT02138461|E1|Reported Event|Bimatoprost|These patients take bimatoprost topically for glaucoma.
23340|NCT02138097|B19|Baseline|Total|Total of all reporting groups
23341|NCT02138097|B18|Baseline|MS: GLP-I RA|Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23342|NCT02138097|B17|Baseline|MS: Alpha-Glucosidase Inhibitors|Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23343|NCT02138097|B16|Baseline|MS: Meglitinides|Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23344|NCT02138097|B15|Baseline|MS: Glitazones|Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23345|NCT02138097|B14|Baseline|MS: Sulfonylurea|Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23346|NCT02138097|B13|Baseline|MS: Metformin|Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
23347|NCT02138097|B12|Baseline|MS: Saxagliptin|Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23348|NCT02138097|B11|Baseline|MS: Sitagliptin|Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23349|NCT02138097|B10|Baseline|MS: Linagliptin|Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23350|NCT02138097|B9|Baseline|UHC: GLP-I RA|Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23351|NCT02138097|B8|Baseline|UHC: Alpha-Glucosidase Inhibitors|Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23352|NCT02138097|B7|Baseline|UHC: Sulfonylurea|Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23353|NCT02138097|B6|Baseline|UHC: Sitagliptin|Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23354|NCT02138097|B5|Baseline|UHC: Saxagliptin|Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23355|NCT02138097|B4|Baseline|UHC: Metformin|Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
23356|NCT02138097|B3|Baseline|UHC: Meglitinides|Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23357|NCT02138097|B2|Baseline|UHC: Linagliptin|Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23358|NCT02138097|B1|Baseline|UHC: Glitazones|Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23359|NCT02138097|P2|Participant Flow|MarketScan|Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
23360|NCT02138097|P1|Participant Flow|United Healthcare|Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database
23361|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23362|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23363|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23364|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23365|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23366|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23367|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23368|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23369|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
24574|NCT02121860|B1|Baseline|Child-Pugh Class A|Mild Hepatic Impairment
23371|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23372|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23373|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23374|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23375|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23376|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23377|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23378|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23379|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23380|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23381|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23382|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23383|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23384|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23385|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23386|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23387|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23388|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23389|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23390|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23391|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23392|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23393|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23394|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23395|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23396|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23397|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23398|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23399|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23400|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23401|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23402|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23403|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23404|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23405|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23406|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23407|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23408|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23409|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23410|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23411|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23412|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23413|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23414|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23415|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23416|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23417|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23418|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23419|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23420|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23421|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23422|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23423|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23424|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23425|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23426|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23427|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23428|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23429|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23430|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23431|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23432|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23433|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23434|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23435|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23436|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23437|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23438|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23439|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23440|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23441|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23442|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23443|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23444|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23445|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23446|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23447|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23448|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23449|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23450|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23451|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23452|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23453|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23454|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23455|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23456|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23457|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23458|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23459|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23460|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23461|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23462|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23463|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23464|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23465|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23466|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23467|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23468|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23469|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23470|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23471|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23472|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23473|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23474|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23475|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23476|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23477|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23478|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23479|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23480|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23481|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23482|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23483|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23484|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23485|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23486|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23487|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23488|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23489|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23490|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23491|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23492|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23493|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23494|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23495|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23496|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23497|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23498|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23499|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23500|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23501|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23502|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23503|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23504|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23505|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23506|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23507|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23508|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
45508|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
23509|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23510|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23511|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23512|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23513|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23514|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23515|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23516|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23517|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23518|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23519|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23520|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23521|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23522|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23523|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23524|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23525|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23526|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23527|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23528|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23529|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23530|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23531|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23532|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23533|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23534|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23535|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23536|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23537|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23538|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23539|NCT02138097|E10|Reported Event|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
23540|NCT02138097|E9|Reported Event|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
23541|NCT02138097|E8|Reported Event|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
23542|NCT02138097|E7|Reported Event|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
23543|NCT02138097|E6|Reported Event|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
23544|NCT02138097|E5|Reported Event|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
23545|NCT02138097|E4|Reported Event|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
23546|NCT02138097|E3|Reported Event|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
23547|NCT02138097|E2|Reported Event|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
23548|NCT02138097|E1|Reported Event|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
23549|NCT02138006|B3|Baseline|Total|Total of all reporting groups
23550|NCT02138006|B2|Baseline|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
23551|NCT02138006|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
23552|NCT02138006|P2|Participant Flow|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
23553|NCT02138006|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
23554|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
23555|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
23556|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
23557|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
23558|NCT02138006|E2|Reported Event|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
23559|NCT02138006|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
23560|NCT02137785|B3|Baseline|Total|Total of all reporting groups
23561|NCT02137785|B2|Baseline|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23562|NCT02137785|B1|Baseline|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23563|NCT02137785|P2|Participant Flow|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23564|NCT02137785|P1|Participant Flow|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23565|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23566|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23567|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23568|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23569|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23570|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23571|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23572|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23573|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23574|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23575|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23576|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23577|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23578|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23579|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23580|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23581|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23582|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23583|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23584|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23585|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23842|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23586|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23587|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23588|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23589|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23590|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23591|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23592|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23593|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23594|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23595|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23596|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23597|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23598|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23599|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23600|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23601|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23602|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23603|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23604|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23605|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23606|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23607|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23608|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23609|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23610|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23611|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23612|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23843|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23613|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23614|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23615|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23616|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23617|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23618|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23619|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23620|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23621|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23622|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23623|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23624|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23625|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23626|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23627|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23628|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23629|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23630|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23631|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23632|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23633|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23634|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23635|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23636|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23637|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23638|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23639|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
24575|NCT02121860|P4|Participant Flow|Child-Pugh Class C|Severe hepatic impairment
23640|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23641|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23642|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23643|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23644|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23645|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23646|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23647|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23648|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23649|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23650|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23651|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23652|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23653|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23654|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23655|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23656|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23657|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23658|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23659|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23660|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23661|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23662|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23663|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23664|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23665|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23666|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23844|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23667|NCT02137785|E2|Reported Event|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23668|NCT02137785|E1|Reported Event|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
23669|NCT02137603|B3|Baseline|Total|Total of all reporting groups
23670|NCT02137603|B2|Baseline|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
23671|NCT02137603|B1|Baseline|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
23672|NCT02137603|P2|Participant Flow|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
23673|NCT02137603|P1|Participant Flow|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
23674|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
23675|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
23676|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
23677|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
23678|NCT02137603|E2|Reported Event|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
23679|NCT02137603|E1|Reported Event|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
23680|NCT02137512|B1|Baseline|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23681|NCT02137512|P1|Participant Flow|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23682|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23683|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23684|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23685|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
45509|NCT01937130|E4|Reported Event|Placebo|"Dosed twice daily~Placebo"
23686|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23687|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23688|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23689|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23690|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23691|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23692|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23693|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23694|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23695|NCT02137512|E1|Reported Event|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
23696|NCT02137382|B1|Baseline|Sequence Creon N/Creon® or Creon®/Creon N|Participants who were randomized to receive either Creon N or Creon.
23697|NCT02137382|P2|Participant Flow|Sequence: Creon®/Creon N|Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
23698|NCT02137382|P1|Participant Flow|Sequence: Creon N/Creon®|Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
23699|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23700|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23701|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23702|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23703|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23704|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23705|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23706|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23707|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23708|NCT02137382|O1|Outcome|Creon®|Creon® : active comparator
23709|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23710|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23711|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
23712|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
23713|NCT02137382|E2|Reported Event|Creon N|Creon N: experimental drug
23714|NCT02137382|E1|Reported Event|Creon®|Creon®: active comparator
23715|NCT02136498|B3|Baseline|Total|Total of all reporting groups
23716|NCT02136498|B2|Baseline|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
23717|NCT02136498|B1|Baseline|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
23718|NCT02136498|P2|Participant Flow|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
23719|NCT02136498|P1|Participant Flow|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
23720|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
23721|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
23722|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
23723|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
23724|NCT02136498|E2|Reported Event|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
23725|NCT02136498|E1|Reported Event|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
23726|NCT02136238|B3|Baseline|Total|Total of all reporting groups
23727|NCT02136238|B2|Baseline|Experimental Group: Unilateral TR or Wrist-disartic Amputees|Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
23728|NCT02136238|B1|Baseline|Non-amputee Control Group|non-amputee healthy controls
48024|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
23729|NCT02136238|P3|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
23730|NCT02136238|P2|Participant Flow|Voluntary Close Device First Then Voluntary Open Device|Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
23731|NCT02136238|P1|Participant Flow|Voluntary Open Device First Then Voluntary Close Device|Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
23732|NCT02136238|O3|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
23733|NCT02136238|O2|Outcome|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
23734|NCT02136238|O1|Outcome|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
23735|NCT02136238|O3|Outcome|Non-amputee Controls|This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
23736|NCT02136238|O2|Outcome|Prosthetic Hand 2 (TRS Grip 3)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2~TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device (hand)"
23737|NCT02136238|O1|Outcome|Prosthetic Hand 1 (Hosmer 5XA)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1~Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device (hand)"
23738|NCT02136238|E3|Reported Event|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
23739|NCT02136238|E2|Reported Event|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
23740|NCT02136238|E1|Reported Event|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
23741|NCT02136134|B3|Baseline|Total|Total of all reporting groups
23742|NCT02136134|B2|Baseline|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23743|NCT02136134|B1|Baseline|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23744|NCT02136134|P2|Participant Flow|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23745|NCT02136134|P1|Participant Flow|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23746|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23747|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23748|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23749|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23750|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23751|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23752|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23753|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23754|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23755|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23756|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23757|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23758|NCT02136134|E2|Reported Event|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23759|NCT02136134|E1|Reported Event|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
23760|NCT02136004|B3|Baseline|Total|Total of all reporting groups
23761|NCT02136004|B2|Baseline|Closer VSS - Interventional Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.~Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23762|NCT02136004|B1|Baseline|Closer VSS - Diagnostic Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.~Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23763|NCT02136004|P1|Participant Flow|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23764|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23765|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23766|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23767|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23768|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23769|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23770|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23771|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23772|NCT02136004|E1|Reported Event|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
23773|NCT02135900|B1|Baseline|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23774|NCT02135900|P1|Participant Flow|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23775|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23776|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23777|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23778|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23779|NCT02135900|E1|Reported Event|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
23780|NCT02135016|B4|Baseline|Total|Total of all reporting groups
23781|NCT02135016|B3|Baseline|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23782|NCT02135016|B2|Baseline|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23783|NCT02135016|B1|Baseline|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23784|NCT02135016|P3|Participant Flow|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23785|NCT02135016|P2|Participant Flow|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23786|NCT02135016|P1|Participant Flow|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23787|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23788|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23789|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23790|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23791|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23792|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23793|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23794|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23795|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23796|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23797|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23798|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23799|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23800|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23801|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23802|NCT02135016|E3|Reported Event|Group C|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
23803|NCT02135016|E2|Reported Event|Group B|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
23804|NCT02135016|E1|Reported Event|Group A|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
23805|NCT02134977|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23806|NCT02134977|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23807|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23808|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23809|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23810|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23811|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23812|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23813|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23814|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23815|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23816|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23845|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23817|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23818|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23819|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23820|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23821|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23822|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23823|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23824|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23825|NCT02134977|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
23826|NCT02134587|B1|Baseline|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23827|NCT02134587|P1|Participant Flow|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23828|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Skills of health professionals in fill correctly the adverse drug events form before educational intervention
23829|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Skills of health professionals in fill correctly the adverse drug events form after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23830|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Knowledge of health professionals before the educational intervention regarding pharmacovigilance
23831|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Knowledge of health professionals after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23832|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
23833|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23834|NCT02134587|E1|Reported Event|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
23835|NCT02134184|B4|Baseline|Total|Total of all reporting groups
23836|NCT02134184|B3|Baseline|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
23837|NCT02134184|B2|Baseline|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
23838|NCT02134184|B1|Baseline|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
23839|NCT02134184|P3|Participant Flow|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23840|NCT02134184|P2|Participant Flow|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23841|NCT02134184|P1|Participant Flow|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
49856|NCT01900067|O2|Outcome|Control|No active warming, standard of care
23846|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23847|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23848|NCT02134184|E3|Reported Event|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23849|NCT02134184|E2|Reported Event|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23850|NCT02134184|E1|Reported Event|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
23851|NCT02134119|B3|Baseline|Total|Total of all reporting groups
23852|NCT02134119|B2|Baseline|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23853|NCT02134119|B1|Baseline|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23854|NCT02134119|P2|Participant Flow|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23855|NCT02134119|P1|Participant Flow|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23856|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23857|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23858|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23859|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23860|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23861|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23862|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23863|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23864|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23865|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23866|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23867|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23868|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23869|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23870|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23871|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23872|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23873|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23874|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23875|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23876|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23877|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23878|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23879|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23880|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23881|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
52631|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
23882|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23883|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23884|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23885|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23886|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23887|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23888|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23889|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23890|NCT02134119|E2|Reported Event|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
23891|NCT02134119|E1|Reported Event|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
23892|NCT02133534|B1|Baseline|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
23893|NCT02133534|P1|Participant Flow|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
23894|NCT02133534|O1|Outcome|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
23895|NCT02133534|E1|Reported Event|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
23896|NCT02133235|B3|Baseline|Total|Total of all reporting groups
23897|NCT02133235|B2|Baseline|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
23898|NCT02133235|B1|Baseline|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
23899|NCT02133235|P2|Participant Flow|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
23900|NCT02133235|P1|Participant Flow|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
23901|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
23902|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
23903|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
23904|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
23905|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
23906|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
23907|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
23908|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
23909|NCT02133235|E2|Reported Event|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
23910|NCT02133235|E1|Reported Event|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
23911|NCT02133131|B8|Baseline|Total|Total of all reporting groups
23912|NCT02133131|B7|Baseline|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23913|NCT02133131|B6|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23914|NCT02133131|B5|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23915|NCT02133131|B4|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23916|NCT02133131|B3|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23917|NCT02133131|B2|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23918|NCT02133131|B1|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23919|NCT02133131|P7|Participant Flow|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23920|NCT02133131|P6|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23921|NCT02133131|P5|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23922|NCT02133131|P4|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23923|NCT02133131|P3|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23924|NCT02133131|P2|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23925|NCT02133131|P1|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23926|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23927|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23928|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23929|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23930|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23931|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23932|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23933|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23934|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23935|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23936|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23937|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23938|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23939|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23940|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23941|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23942|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23943|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23944|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
24576|NCT02121860|P3|Participant Flow|Child-Pugh Class B|Moderate hepatic impairment
23945|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23946|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23947|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23948|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23949|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23950|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23951|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23952|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23953|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23954|NCT02133131|E7|Reported Event|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23955|NCT02133131|E6|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
23956|NCT02133131|E5|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23957|NCT02133131|E4|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
23958|NCT02133131|E3|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23959|NCT02133131|E2|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
23960|NCT02133131|E1|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
23961|NCT02132936|B5|Baseline|Total|Total of all reporting groups
23962|NCT02132936|B4|Baseline|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
23963|NCT02132936|B3|Baseline|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
23964|NCT02132936|B2|Baseline|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
23965|NCT02132936|B1|Baseline|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
23966|NCT02132936|P4|Participant Flow|Gel Vehicle|Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
23967|NCT02132936|P3|Participant Flow|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
23968|NCT02132936|P2|Participant Flow|Aerosol Foam Vehicle|Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
23969|NCT02132936|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
23970|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
23971|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
23972|NCT02132936|O2|Outcome|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
23973|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
23974|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
23975|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
23976|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
23977|NCT02132936|O1|Outcome|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
23978|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
23979|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
23980|NCT02132936|E4|Reported Event|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
23981|NCT02132936|E3|Reported Event|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
23982|NCT02132936|E2|Reported Event|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
24012|NCT02132572|B1|Baseline|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
23983|NCT02132936|E1|Reported Event|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
23984|NCT02132767|B3|Baseline|Total|Total of all reporting groups
23985|NCT02132767|B2|Baseline|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23986|NCT02132767|B1|Baseline|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23987|NCT02132767|P2|Participant Flow|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23988|NCT02132767|P1|Participant Flow|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23989|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23990|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23991|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23992|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23993|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23994|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23995|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23996|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23997|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
23998|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
23999|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
24000|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
24013|NCT02132572|P1|Participant Flow|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
24014|NCT02132572|O1|Outcome|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
24001|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
24002|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
24003|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
24004|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
24005|NCT02132767|E2|Reported Event|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
24006|NCT02132767|E1|Reported Event|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
24007|NCT02132611|B1|Baseline|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
24008|NCT02132611|P1|Participant Flow|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
24009|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
24010|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
24011|NCT02132611|E1|Reported Event|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
24577|NCT02121860|P2|Participant Flow|Child-Pugh Class A|Mild hepatic impairment
24015|NCT02132572|E1|Reported Event|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
24016|NCT02132117|B3|Baseline|Total|Total of all reporting groups
24017|NCT02132117|B2|Baseline|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24018|NCT02132117|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24019|NCT02132117|P2|Participant Flow|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24020|NCT02132117|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
24021|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24022|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24023|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24024|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24025|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24026|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24027|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24028|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24029|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24030|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24031|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24032|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24033|NCT02132117|E2|Reported Event|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
24034|NCT02132117|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
24035|NCT02131636|B3|Baseline|Total|Total of all reporting groups
24036|NCT02131636|B2|Baseline|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24037|NCT02131636|B1|Baseline|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24038|NCT02131636|P2|Participant Flow|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24039|NCT02131636|P1|Participant Flow|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24040|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24041|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24042|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24043|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24044|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24045|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24046|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24047|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24048|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24049|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24050|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24051|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24052|NCT02131636|E2|Reported Event|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
24053|NCT02131636|E1|Reported Event|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
24054|NCT02131532|B1|Baseline|Intervention Group|Baseline characteristics of eight participants who completed all treatment sessions
24055|NCT02131532|P1|Participant Flow|Psychological Intervention|All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
24056|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24057|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24058|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24059|NCT02131532|O1|Outcome|Intervention Group|This outcome presents the recruitment process. However, only eight participants who completed all treatment sessions were included for further analysis of clinical outcomes.
24060|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24061|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24062|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24063|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24064|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24065|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24066|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24067|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
25634|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
24068|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24069|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24070|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24071|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24072|NCT02131532|E1|Reported Event|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
24073|NCT02131402|B1|Baseline|Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
24074|NCT02131402|P1|Participant Flow|Overall Participants Flow|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye."
24075|NCT02131402|O2|Outcome|Methafilcon A|Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
24076|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
24077|NCT02131402|O2|Outcome|Ocufilcon D|Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
24078|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
24079|NCT02131402|O2|Outcome|Omafilcon A|Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
24080|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
24081|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after1 hour wearing Omafilcon A in contralateral eye
24082|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour wearing Enfilcon A in one eye
24083|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at 1 hour post settling (3 hours) wearing Methafilcon A in contralateral eye
24084|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling (3 hours), wearing Enfilcon A in one eye
24085|NCT02131402|O2|Outcome|Ocufilcon D|Participants surveyed at 1 hour post settling (2 hours), wearing Ocufilcon D in contralateral eye
24086|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling (2 hours), wearing Enfilcon A in one eye
24087|NCT02131402|O2|Outcome|Ocufilcon D|Surveyed after insertion (1 hour at insertion) wearing Ocufilcon D in contralateral eye
24088|NCT02131402|O1|Outcome|Enfilcon A|Surveyed after insertion (1 hour at insertion) wearing Enfilcon A in one eye
24089|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed after insertion at 2 hours, wearing Methafilcon A in contralateral eye
24090|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after insertion at 2 hours, wearing Enfilcon A in one eye
24091|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
24092|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
24093|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling (3 hours), wearing Methafilcon A in contralateral eye
24094|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling (3 hours), wearing Enfilcon A in one eye
24095|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling (2 hours) wearing Ocufilcon D in contralateral eye
24096|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (2 hours) wearing Enfilcon A in one eye
24097|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling (1 hour), wearing Omafilcon A in contralateral eye
24098|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (1 hour) wearing Enfilcon A in one eye
24099|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling (3 hours). Push up test, wearing Methafilcon A in contralateral eye
24100|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling (3 hours). Push up test, wearing Enfilcon A in one eye
24101|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling (2 hours). Push up test, wearing Ocufilcon D in contralateral eye
24102|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (2 hours). Push up test, wearing Enfilcon A in one eye
24103|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling (1 hour). Push up test, wearing Omafilcon A in contralateral eye
24104|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (1 hour). Push up test, wearing Enfilcon A in one eye
24105|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling (3 hours). Post-blink movement, wearing Ocufilcon D in contralateral eye
24106|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling (3 hours). Post-blink movement, wearing Enfilcon A in one eye
24107|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling (1 hour). Post-blink movement, wearing Omafilcon A in contralateral eye
24108|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (1 hour). Post-blink movement, wearing Enfilcon A in one eye
24109|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling (2 hours). Post-blink movement, wearing Ocufilcon D in contralateral eye
24110|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling (2 hours). Post-blink movement, wearing Enfilcon A in one eye
24111|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling (3 hours)
52632|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
24112|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye, surveyed at 1 hour post settling (3 hours)
24113|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling (2 hours).
24114|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling (2 hours).
24115|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
24116|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
24117|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after insertion of each lens Pair #2 (1 hour at insertion)
24118|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (1 hour at insertion)
24119|NCT02131402|O2|Outcome|Methafilcon A|Subject surveyed after insertion of each lens for Pair #3 (2 hours) wearing Methafilcon A in the contralateral eye.
24120|NCT02131402|O1|Outcome|Enfilcon A|Subject surveyed after insertion of each lens for Pair #3 (2 hours) wearing Enfilcon A in one eye
24121|NCT02131402|O2|Outcome|Omafilcon A|Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
24122|NCT02131402|O1|Outcome|Enfilcon A|Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
24123|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
24124|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling (3 hours), wearing Enfilcon A in one eye
24125|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling (2 hours) for Pair #2.
24126|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling (2 hours) for Pair #2
24127|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
24128|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
24129|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contra lateral eye. Participants surveyed at 2 hours (insertion).
24130|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Participants surveyed at 2 hours (insertion).
24131|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
24132|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
24133|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (1 hour at insertion).
24134|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (1 hour at insertion).
24135|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3 at (3 hours)
24136|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3 at (3 hours)
24137|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (2 hours)
24138|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (2 hours)
24139|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
24140|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
24141|NCT02131402|E3|Reported Event|Enfilcon A / Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
24142|NCT02131402|E2|Reported Event|Enfilcon A / Ocufilcon D|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye."
24143|NCT02131402|E1|Reported Event|Enfilcon A / Omafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye."
24144|NCT02131311|B1|Baseline|Pessary|disposable, single-use pessary
24145|NCT02131311|P1|Participant Flow|Pessary|disposable, single-use pessary
24146|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24147|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24148|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24149|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24150|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24151|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
24152|NCT02131311|O1|Outcome|Pessary|"disposable, single-use pessary~disposable, single-use pessary"
24153|NCT02131311|E1|Reported Event|Pessary|disposable, single-use pessary
24154|NCT02131233|B3|Baseline|Total|Total of all reporting groups
24155|NCT02131233|B2|Baseline|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24156|NCT02131233|B1|Baseline|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24364|NCT02126306|B2|Baseline|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24157|NCT02131233|P2|Participant Flow|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24158|NCT02131233|P1|Participant Flow|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24159|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24160|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24161|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24162|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24163|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24164|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24165|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24166|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24167|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24168|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24169|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24170|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24171|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24172|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24173|NCT02131233|E2|Reported Event|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
24174|NCT02131233|E1|Reported Event|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
24175|NCT02130999|B1|Baseline|Overall Number of Baseline Participants|14 subjects total participated in the study
24176|NCT02130999|P2|Participant Flow|Sequence B|"Single I.V. dose of tasimelteon 2 mg on Day 1~Single oral dose of tasimelteon 20 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
24177|NCT02130999|P1|Participant Flow|Sequence A|"Single oral dose of tasimelteon 20 mg on Day 1~Single I.V. dose of tasimelteon 2 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
24178|NCT02130999|O3|Outcome|All Subjects|
24179|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
24180|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
24181|NCT02130999|O3|Outcome|All Subjects|
24182|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
24183|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
24184|NCT02130999|O2|Outcome|IV (2 mg)|
24185|NCT02130999|O1|Outcome|Oral (20 mg)|
24186|NCT02130999|O2|Outcome|IV (2 mg)|
24187|NCT02130999|O1|Outcome|Oral (20 mg)|
24188|NCT02130999|O2|Outcome|IV (2 mg)|
24189|NCT02130999|O1|Outcome|Oral (20 mg)|
24190|NCT02130999|O2|Outcome|IV (2 mg)|
24191|NCT02130999|O1|Outcome|Oral (20 mg)|
24192|NCT02130999|O2|Outcome|IV (2 mg)|
24193|NCT02130999|O1|Outcome|Oral (20 mg)|
24194|NCT02130999|O2|Outcome|IV (2 mg)|
24195|NCT02130999|O1|Outcome|Oral (20 mg)|
24196|NCT02130999|O2|Outcome|IV (2 mg)|
24197|NCT02130999|O1|Outcome|Oral (20 mg)|
24198|NCT02130999|O1|Outcome|Absolute Bioavailability|
24199|NCT02130999|E3|Reported Event|All Subjects|
24200|NCT02130999|E2|Reported Event|Tasimelteon 2mg IV|
24201|NCT02130999|E1|Reported Event|Tasimelteon 20mg Oral|
24202|NCT02129608|B4|Baseline|Total|Total of all reporting groups
24203|NCT02129608|B3|Baseline|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24204|NCT02129608|B2|Baseline|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24205|NCT02129608|B1|Baseline|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
24242|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24206|NCT02129608|P3|Participant Flow|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24207|NCT02129608|P2|Participant Flow|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24208|NCT02129608|P1|Participant Flow|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
24209|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24210|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24211|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
24212|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24213|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24214|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
24215|NCT02129608|E3|Reported Event|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24216|NCT02129608|E2|Reported Event|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
24217|NCT02129608|E1|Reported Event|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
24218|NCT02129062|B1|Baseline|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
24219|NCT02129062|P1|Participant Flow|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
24220|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
24221|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
24222|NCT02129062|E1|Reported Event|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
24223|NCT02128867|B4|Baseline|Total|Total of all reporting groups
24224|NCT02128867|B3|Baseline|Bouncing|"bouncing . intervention to relax the infant~bouncing"
24225|NCT02128867|B2|Baseline|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
24226|NCT02128867|B1|Baseline|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
24227|NCT02128867|P3|Participant Flow|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
24228|NCT02128867|P2|Participant Flow|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
24229|NCT02128867|P1|Participant Flow|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
24230|NCT02128867|O3|Outcome|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
24231|NCT02128867|O2|Outcome|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
24232|NCT02128867|O1|Outcome|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
24233|NCT02128867|E3|Reported Event|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
24234|NCT02128867|E2|Reported Event|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
24235|NCT02128867|E1|Reported Event|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
24236|NCT02128542|B3|Baseline|Total|Total of all reporting groups
24237|NCT02128542|B2|Baseline|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24238|NCT02128542|B1|Baseline|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24239|NCT02128542|P2|Participant Flow|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24240|NCT02128542|P1|Participant Flow|SOF+RBV 12 Weeks (TN)|Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24241|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24243|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24244|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24245|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24246|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24247|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24248|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24249|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24250|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24251|NCT02128542|E1|Reported Event|SOF+RBV 12 Weeks (All Participants)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
24252|NCT02128490|B6|Baseline|Total|Total of all reporting groups
24253|NCT02128490|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24254|NCT02128490|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24255|NCT02128490|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24256|NCT02128490|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24257|NCT02128490|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24258|NCT02128490|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24259|NCT02128490|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24260|NCT02128490|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24261|NCT02128490|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24262|NCT02128490|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24263|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24264|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24265|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24266|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24267|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24268|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24269|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24270|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24317|NCT02126839|B2|Baseline|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24271|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24272|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24273|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24274|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24275|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24276|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24277|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24278|NCT02128490|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24279|NCT02128490|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24280|NCT02128490|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24281|NCT02128490|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24282|NCT02128490|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
24283|NCT02127567|B1|Baseline|All Participants|
24284|NCT02127567|P1|Participant Flow|All Participants|"All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24285|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24286|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24287|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24288|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24318|NCT02126839|B1|Baseline|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24319|NCT02126839|P2|Participant Flow|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24289|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24290|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24291|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24292|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24293|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24294|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24295|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24296|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24297|NCT02127567|O2|Outcome|Writing With no Specific Support.|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24298|NCT02127567|O1|Outcome|Online Writing Tool|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24299|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24320|NCT02126839|P1|Participant Flow|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24300|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24301|NCT02127567|E2|Reported Event|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
24302|NCT02127567|E1|Reported Event|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
24303|NCT02127372|B3|Baseline|Total|Total of all reporting groups
24304|NCT02127372|B2|Baseline|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24305|NCT02127372|B1|Baseline|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24306|NCT02127372|P2|Participant Flow|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24307|NCT02127372|P1|Participant Flow|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24308|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24309|NCT02127372|O2|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24310|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24311|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24312|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24313|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24314|NCT02127372|E2|Reported Event|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
24315|NCT02127372|E1|Reported Event|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
24316|NCT02126839|B3|Baseline|Total|Total of all reporting groups
24321|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24322|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24323|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24324|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24325|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24326|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24327|NCT02126839|E2|Reported Event|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
24328|NCT02126839|E1|Reported Event|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
24329|NCT02126748|B4|Baseline|Total|Total of all reporting groups
24330|NCT02126748|B3|Baseline|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
24331|NCT02126748|B2|Baseline|Assisted Autogenic Drainage|20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
24332|NCT02126748|B1|Baseline|Intrapulmonary Percussive Ventilation|20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
24333|NCT02126748|P3|Participant Flow|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
24334|NCT02126748|P2|Participant Flow|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
24335|NCT02126748|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
24336|NCT02126748|O3|Outcome|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
24337|NCT02126748|O2|Outcome|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
24338|NCT02126748|O1|Outcome|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
24339|NCT02126748|E3|Reported Event|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
24340|NCT02126748|E2|Reported Event|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
24341|NCT02126748|E1|Reported Event|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
24342|NCT02126670|B5|Baseline|Total|Total of all reporting groups
24343|NCT02126670|B4|Baseline|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
24344|NCT02126670|B3|Baseline|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
24345|NCT02126670|B2|Baseline|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
24346|NCT02126670|B1|Baseline|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
24347|NCT02126670|P4|Participant Flow|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
24348|NCT02126670|P3|Participant Flow|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
24349|NCT02126670|P2|Participant Flow|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
24350|NCT02126670|P1|Participant Flow|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
24351|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
24352|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
24353|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
24354|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
24355|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
24356|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
24357|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
24358|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
24359|NCT02126670|E4|Reported Event|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
24360|NCT02126670|E3|Reported Event|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
24361|NCT02126670|E2|Reported Event|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
24362|NCT02126670|E1|Reported Event|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
24363|NCT02126306|B3|Baseline|Total|Total of all reporting groups
24365|NCT02126306|B1|Baseline|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24366|NCT02126306|P2|Participant Flow|Beta Glucosylceramide|"Beta Glucosylceramide 7.5 mg~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24367|NCT02126306|P1|Participant Flow|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24368|NCT02126306|O2|Outcome|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
24369|NCT02126306|O1|Outcome|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
24370|NCT02126306|E2|Reported Event|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24371|NCT02126306|E1|Reported Event|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
24372|NCT02125877|B3|Baseline|Total|Total of all reporting groups
24373|NCT02125877|B2|Baseline|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24374|NCT02125877|B1|Baseline|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24375|NCT02125877|P2|Participant Flow|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24376|NCT02125877|P1|Participant Flow|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24377|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24378|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24379|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24380|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24381|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24382|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24383|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24384|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24385|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24386|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24387|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24388|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24470|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
24389|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24390|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24391|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24392|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24393|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24394|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24395|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24396|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24397|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24398|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24399|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24400|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24401|NCT02125877|E2|Reported Event|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
24402|NCT02125877|E1|Reported Event|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
24403|NCT02125734|B3|Baseline|Total|Total of all reporting groups
24404|NCT02125734|B2|Baseline|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
24405|NCT02125734|B1|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
24406|NCT02125734|P2|Participant Flow|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
24407|NCT02125734|P1|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
24408|NCT02125734|O2|Outcome|Tiotropium|
24409|NCT02125734|O1|Outcome|QVA149|
24410|NCT02125734|O2|Outcome|Tiotropium|
24411|NCT02125734|O1|Outcome|QVA149|
24412|NCT02125734|O2|Outcome|Tiotropium|
24413|NCT02125734|O1|Outcome|QVA149|
24414|NCT02125734|E2|Reported Event|Tiotropium|Tiotropium
24415|NCT02125734|E1|Reported Event|QVA149|QVA149
24416|NCT02125292|B1|Baseline|All Participants|
24417|NCT02125292|P6|Participant Flow|Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
26838|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
24418|NCT02125292|P5|Participant Flow|Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
24419|NCT02125292|P4|Participant Flow|Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
24420|NCT02125292|P3|Participant Flow|Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
24421|NCT02125292|P2|Participant Flow|Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
24422|NCT02125292|P1|Participant Flow|Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
24423|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
24424|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
24425|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
24426|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
24427|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24428|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24429|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24430|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24431|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24432|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24433|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24434|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24435|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24436|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24437|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24438|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24439|NCT02125292|E3|Reported Event|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24440|NCT02125292|E2|Reported Event|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24441|NCT02125292|E1|Reported Event|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
24442|NCT02124863|B1|Baseline|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
24443|NCT02124863|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
24444|NCT02124863|O2|Outcome|Control|mean number of refluxes during 20 min, 120 min after each meal
24445|NCT02124863|O1|Outcome|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
24446|NCT02124863|E2|Reported Event|Control|mean number of refluxes during 20 min, 120 min after each meal
24447|NCT02124863|E1|Reported Event|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
24448|NCT02124603|B1|Baseline|Single Group|Consecutive patients scheduled for cataract surgery
24449|NCT02124603|P1|Participant Flow|Single Group|Patients undergone cataract surgery
24450|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
24451|NCT02124603|O1|Outcome|Single Group|patients undergone cataract surgery
24452|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
24453|NCT02124603|E1|Reported Event|Single Group|Patients to have to undergone cataract surgery
24454|NCT02123472|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion)
24455|NCT02123472|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
24456|NCT02123472|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
24457|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24458|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24459|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24460|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24461|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24462|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24463|NCT02123472|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24464|NCT02123472|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24465|NCT02123459|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
24466|NCT02123459|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
24467|NCT02123459|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
24468|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
24469|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
24471|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
24472|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
24473|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
24474|NCT02123459|E2|Reported Event|Cephalexin (Test)|"Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods~Cephalexin: Administered orally"
24475|NCT02123459|E1|Reported Event|Cephalexin (Reference)|"Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods~Cephalexin: Administered orally"
24476|NCT02123446|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
24477|NCT02123446|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
24478|NCT02123446|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
24479|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24480|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24481|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24482|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24483|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24484|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24485|NCT02123446|E2|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
24486|NCT02123446|E1|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
24487|NCT02124304|B3|Baseline|Total|Total of all reporting groups
24488|NCT02124304|B2|Baseline|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24489|NCT02124304|B1|Baseline|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24490|NCT02124304|P2|Participant Flow|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24491|NCT02124304|P1|Participant Flow|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24492|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24493|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24494|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24514|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24495|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24496|NCT02124304|E2|Reported Event|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24497|NCT02124304|E1|Reported Event|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
24498|NCT02124161|B3|Baseline|Total|Total of all reporting groups
24499|NCT02124161|B2|Baseline|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24500|NCT02124161|B1|Baseline|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24501|NCT02124161|P2|Participant Flow|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24502|NCT02124161|P1|Participant Flow|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24503|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24504|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24505|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24506|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24507|NCT02124161|O1|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24508|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24509|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24510|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24511|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24512|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24513|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24568|NCT02122406|O1|Outcome|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
24569|NCT02122406|E1|Reported Event|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
24515|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24516|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24517|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24518|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24519|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24520|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24521|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24522|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
24523|NCT02124161|E8|Reported Event|Placebo+QIV/13vPnC: at 6-Month Follow-up|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
24524|NCT02124161|E7|Reported Event|13vPnC+QIV/Placebo: at 6-Month Follow-up|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
24525|NCT02124161|E6|Reported Event|Placebo+QIV/13vPnC: After 13vPnC Vaccination|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
24526|NCT02124161|E5|Reported Event|13vPnC+QIV/Placebo: After 13vPnC Vaccination|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
24527|NCT02124161|E4|Reported Event|Placebo+QIV/13vPnC: After Vaccination 2|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
24528|NCT02124161|E3|Reported Event|13vPnC+QIV/Placebo: After Vaccination 2|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
24529|NCT02124161|E2|Reported Event|Placebo+QIV/13vPnC: After Vaccination 1|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
24530|NCT02124161|E1|Reported Event|13vPnC+QIV/Placebo: After Vaccination 1|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
24531|NCT02123745|B1|Baseline|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24532|NCT02123745|P1|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24570|NCT02121860|B5|Baseline|Total|Total of all reporting groups
24571|NCT02121860|B4|Baseline|Normal Hepatic Function|Medically healthy as determined by the investigator
24533|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24534|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24535|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24536|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24537|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24538|NCT02123745|E1|Reported Event|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
24539|NCT02123017|B4|Baseline|Total|Total of all reporting groups
24540|NCT02123017|B3|Baseline|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24541|NCT02123017|B2|Baseline|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24542|NCT02123017|B1|Baseline|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24543|NCT02123017|P3|Participant Flow|180 Grams Crystalline Lactulose|15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
24544|NCT02123017|P2|Participant Flow|135 Grams Crystalline Lactulose|15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
24545|NCT02123017|P1|Participant Flow|90 Grams Crystalline Lactulose|15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
24546|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24547|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24548|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24549|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24550|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24551|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24552|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24553|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24554|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24555|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24556|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24557|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24558|NCT02123017|E3|Reported Event|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
24559|NCT02123017|E2|Reported Event|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
24560|NCT02123017|E1|Reported Event|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
24561|NCT02122445|B1|Baseline|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
24562|NCT02122445|P1|Participant Flow|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
24563|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
24564|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
24565|NCT02122445|E1|Reported Event|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
24566|NCT02122406|B1|Baseline|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
24567|NCT02122406|P1|Participant Flow|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
52633|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
24578|NCT02121860|P1|Participant Flow|Normal Hepatic Function|Medically healthy as determined by the investigator
24579|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
24580|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
24581|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
24582|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
24583|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
24584|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
24585|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
24586|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
24587|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
24588|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
24589|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
24590|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
24591|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
24592|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
24593|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
24594|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
24595|NCT02121860|E1|Reported Event|IDN-6556|Single 50 mg oral dose of IDN-6556
24596|NCT02121847|B1|Baseline|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24597|NCT02121847|P1|Participant Flow|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24598|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24599|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24600|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24601|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24602|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24603|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24604|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24605|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24606|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24607|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24608|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24609|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24610|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24611|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24612|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24613|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24614|NCT02121847|E1|Reported Event|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
24615|NCT02121795|B3|Baseline|Total|Total of all reporting groups
24616|NCT02121795|B2|Baseline|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24617|NCT02121795|B1|Baseline|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24618|NCT02121795|P2|Participant Flow|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24619|NCT02121795|P1|Participant Flow|F/TAF + 3rd Agent|Emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks
24620|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24621|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24622|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24623|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24624|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24625|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24626|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24627|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24628|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24629|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24630|NCT02121795|E2|Reported Event|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
24631|NCT02121795|E1|Reported Event|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
24632|NCT02121522|B1|Baseline|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
24633|NCT02121522|P1|Participant Flow|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
24634|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
24635|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
24636|NCT02121522|E1|Reported Event|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
24637|NCT02121509|B3|Baseline|Total|Total of all reporting groups
24638|NCT02121509|B2|Baseline|FDC 1500 Fed or L+M 1500 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24639|NCT02121509|B1|Baseline|FDC 1500 Fasted or L+M 1500 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24640|NCT02121509|P4|Participant Flow|L+M 1500 Fed / FDC 1500 Fed|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24641|NCT02121509|P3|Participant Flow|FDC 1500 Fed / L+M 1500 Fed|"Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24642|NCT02121509|P2|Participant Flow|L+M 1500 Fasted / FDC 1500 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24643|NCT02121509|P1|Participant Flow|FDC 1500 Fasted / L+M 1500 Fasted|"Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
24644|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24645|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24682|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24646|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24647|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24648|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24649|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24650|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24651|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24652|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24653|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24654|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24655|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24656|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24657|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24658|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24659|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24660|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24661|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24662|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24663|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24664|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24665|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24666|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24667|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24668|NCT02121509|E4|Reported Event|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
24669|NCT02121509|E3|Reported Event|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
24670|NCT02121509|E2|Reported Event|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
24671|NCT02121509|E1|Reported Event|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
24672|NCT02121483|B4|Baseline|Total|Total of all reporting groups
24673|NCT02121483|B3|Baseline|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24674|NCT02121483|B2|Baseline|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24675|NCT02121483|B1|Baseline|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24676|NCT02121483|P3|Participant Flow|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24677|NCT02121483|P2|Participant Flow|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24678|NCT02121483|P1|Participant Flow|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24679|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24680|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24681|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24683|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24684|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24685|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24686|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24687|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24688|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24689|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24690|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24691|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24692|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24693|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24694|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24695|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24696|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24697|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24698|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24699|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24700|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24701|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24702|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24703|NCT02121483|E3|Reported Event|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
24704|NCT02121483|E2|Reported Event|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
24705|NCT02121483|E1|Reported Event|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
24706|NCT02121041|B3|Baseline|Total|Total of all reporting groups
24707|NCT02121041|B2|Baseline|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
24708|NCT02121041|B1|Baseline|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
24709|NCT02121041|P2|Participant Flow|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
24710|NCT02121041|P1|Participant Flow|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
24711|NCT02121041|O2|Outcome|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
24712|NCT02121041|O1|Outcome|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
24713|NCT02121041|E2|Reported Event|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
24714|NCT02121041|E1|Reported Event|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
24715|NCT02120833|B3|Baseline|Total|Total of all reporting groups
24716|NCT02120833|B2|Baseline|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24717|NCT02120833|B1|Baseline|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24718|NCT02120833|P2|Participant Flow|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24719|NCT02120833|P1|Participant Flow|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24720|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24721|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24722|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24723|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24724|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24725|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24726|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24727|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24728|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24729|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24730|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24731|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24732|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24733|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24734|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24735|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24736|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24737|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24738|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24739|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24740|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24741|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24742|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24743|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24744|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24745|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24746|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24747|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24748|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24749|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24750|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24751|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24752|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24753|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24754|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24755|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24756|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24757|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24758|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24759|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24760|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24761|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24762|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24763|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24764|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24765|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24766|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24767|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24768|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24769|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24770|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24771|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24772|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24773|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24774|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24775|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24776|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24777|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24778|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24779|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24780|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24781|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24782|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24783|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24784|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24785|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24786|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24787|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24788|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24789|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24790|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24791|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24792|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24793|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24794|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24795|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24796|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24797|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24798|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24799|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24800|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24801|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24802|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24803|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24804|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24805|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24806|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24807|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24808|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24809|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24810|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24811|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24812|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24813|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24814|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24815|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24816|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24817|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24818|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24819|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24820|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24821|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24822|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24823|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24824|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24825|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24826|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24827|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24828|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24829|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24830|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24831|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24832|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24833|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24834|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24835|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24836|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24837|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24838|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24839|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24840|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24841|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24842|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24843|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24844|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24845|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24846|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24847|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24848|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24849|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24850|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24851|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24852|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24853|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24854|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24855|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24856|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24857|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24858|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24859|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24860|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24861|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24862|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24863|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24864|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24865|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24866|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24867|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24868|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24869|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24870|NCT02120833|E2|Reported Event|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
24871|NCT02120833|E1|Reported Event|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
24872|NCT02120443|B1|Baseline|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24873|NCT02120443|P1|Participant Flow|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24874|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24875|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24876|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24877|NCT02120443|E1|Reported Event|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
24878|NCT02120300|B5|Baseline|Total|Total of all reporting groups
24879|NCT02120300|B4|Baseline|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24880|NCT02120300|B3|Baseline|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24881|NCT02120300|B2|Baseline|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24882|NCT02120300|B1|Baseline|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24883|NCT02120300|P4|Participant Flow|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24884|NCT02120300|P3|Participant Flow|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24885|NCT02120300|P2|Participant Flow|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24886|NCT02120300|P1|Participant Flow|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24887|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24888|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24889|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24890|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24891|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24892|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24893|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24894|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24895|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24896|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24897|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24898|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24899|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24900|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24901|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24902|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24903|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24904|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24905|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24906|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24907|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24908|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24909|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24910|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24911|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24912|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24913|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24914|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24915|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24916|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24917|NCT02120300|E4|Reported Event|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
24918|NCT02120300|E3|Reported Event|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
24919|NCT02120300|E2|Reported Event|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
24920|NCT02120300|E1|Reported Event|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
24921|NCT02120027|B3|Baseline|Total|Total of all reporting groups
24922|NCT02120027|B2|Baseline|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24923|NCT02120027|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24924|NCT02120027|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily."
24925|NCT02120027|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24926|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24927|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24928|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24929|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24930|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24931|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24932|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24933|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24934|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24935|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
24936|NCT02120027|E2|Reported Event|Placebo for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
24937|NCT02120027|E1|Reported Event|Ibodutant 10 mg for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
24938|NCT02119325|B1|Baseline|Overall Participants|
24939|NCT02119325|P2|Participant Flow|Sequence 2|Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24940|NCT02119325|P1|Participant Flow|Sequence 1|Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24941|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24942|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24943|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24944|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24945|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24946|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24947|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24948|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24949|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24950|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24951|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24952|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24953|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24954|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24955|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24956|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24957|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24958|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24959|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24960|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24961|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24962|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24963|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24964|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24965|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24966|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24967|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24968|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24969|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
24970|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24971|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24972|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24973|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24974|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24975|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24976|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24977|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24978|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24979|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24980|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).
52634|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
24981|NCT02119325|E2|Reported Event|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
24982|NCT02119325|E1|Reported Event|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
24983|NCT02119286|B4|Baseline|Total|Total of all reporting groups
24984|NCT02119286|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24985|NCT02119286|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24986|NCT02119286|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24987|NCT02119286|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24988|NCT02119286|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24989|NCT02119286|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24990|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24991|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24992|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24993|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24994|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24995|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24996|NCT02119286|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24997|NCT02119286|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
25038|NCT02118896|P3|Participant Flow|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
24998|NCT02119286|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
24999|NCT02118961|B3|Baseline|Total|Total of all reporting groups
25000|NCT02118961|B2|Baseline|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25001|NCT02118961|B1|Baseline|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25002|NCT02118961|P2|Participant Flow|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25003|NCT02118961|P1|Participant Flow|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25004|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25005|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25006|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25007|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25008|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25009|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25010|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25011|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25012|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25013|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25014|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25015|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25016|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25017|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25018|NCT02118961|E2|Reported Event|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
25019|NCT02118961|E1|Reported Event|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
25020|NCT02118896|B11|Baseline|Total|Total of all reporting groups
25021|NCT02118896|B10|Baseline|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25022|NCT02118896|B9|Baseline|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25023|NCT02118896|B8|Baseline|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25024|NCT02118896|B7|Baseline|PMR-EC-1105|"Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.~Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to"
25025|NCT02118896|B6|Baseline|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25026|NCT02118896|B5|Baseline|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25027|NCT02118896|B4|Baseline|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25028|NCT02118896|B3|Baseline|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25029|NCT02118896|B2|Baseline|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25030|NCT02118896|B1|Baseline|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25031|NCT02118896|P10|Participant Flow|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25032|NCT02118896|P9|Participant Flow|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25033|NCT02118896|P8|Participant Flow|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25034|NCT02118896|P7|Participant Flow|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25035|NCT02118896|P6|Participant Flow|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25036|NCT02118896|P5|Participant Flow|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25037|NCT02118896|P4|Participant Flow|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
26839|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
25039|NCT02118896|P2|Participant Flow|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25040|NCT02118896|P1|Participant Flow|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25041|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25042|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25043|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25044|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25045|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25046|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25047|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25048|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25049|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25050|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25051|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25052|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25053|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25054|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25055|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25056|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25057|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25058|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25059|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25060|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25061|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25062|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25063|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25064|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25065|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25066|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25067|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25068|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25069|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25070|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25071|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study. There were no reported BCAR in subjects in the previous study PMR-EC-1210, Kaplan-Meier estimate not applicable.
25072|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25073|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25074|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25075|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25076|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25077|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
52635|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
25078|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25079|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25080|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25081|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25082|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25083|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25084|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25085|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25086|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25087|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25088|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25089|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25090|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25091|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25092|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25093|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25094|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25095|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25096|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25097|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25098|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25099|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25100|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25101|NCT02118896|E10|Reported Event|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
25102|NCT02118896|E9|Reported Event|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
25103|NCT02118896|E8|Reported Event|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
25104|NCT02118896|E7|Reported Event|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
25105|NCT02118896|E6|Reported Event|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
25106|NCT02118896|E5|Reported Event|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
25107|NCT02118896|E4|Reported Event|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
25108|NCT02118896|E3|Reported Event|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
25109|NCT02118896|E2|Reported Event|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
25110|NCT02118896|E1|Reported Event|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
25111|NCT02118831|B4|Baseline|Total|Total of all reporting groups
25112|NCT02118831|B3|Baseline|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
25113|NCT02118831|B2|Baseline|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
25114|NCT02118831|B1|Baseline|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
25115|NCT02118831|P3|Participant Flow|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
25116|NCT02118831|P2|Participant Flow|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
25117|NCT02118831|P1|Participant Flow|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
25118|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
25119|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
25120|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
25121|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
25122|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
25123|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
25124|NCT02118831|E3|Reported Event|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
25125|NCT02118831|E2|Reported Event|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
25126|NCT02118831|E1|Reported Event|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
25127|NCT02118597|B1|Baseline|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25128|NCT02118597|P1|Participant Flow|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25129|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25130|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25131|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25132|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25133|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25134|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25135|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25136|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25137|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25138|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25164|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25139|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
25140|NCT02118597|E1|Reported Event|Triple Combination Therapy|Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
25141|NCT02118441|B3|Baseline|Total|Total of all reporting groups
25142|NCT02118441|B2|Baseline|Ultrasound|"Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25143|NCT02118441|B1|Baseline|Direct Palpation|"Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25144|NCT02118441|P2|Participant Flow|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25145|NCT02118441|P1|Participant Flow|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25146|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25147|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25148|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25149|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25150|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25151|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25152|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25153|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25154|NCT02118441|E2|Reported Event|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
25155|NCT02118441|E1|Reported Event|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
25156|NCT02117687|B3|Baseline|Total|Total of all reporting groups
25157|NCT02117687|B2|Baseline|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25158|NCT02117687|B1|Baseline|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25159|NCT02117687|P2|Participant Flow|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25160|NCT02117687|P1|Participant Flow|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25161|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25162|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25163|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25165|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25166|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25167|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25168|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25169|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25170|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25171|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25172|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25173|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25174|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25175|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25176|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25177|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25178|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25179|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25180|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25181|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25182|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25183|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25184|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25185|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25186|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25187|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25188|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25189|NCT02117687|E2|Reported Event|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25190|NCT02117687|E1|Reported Event|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
25191|NCT02117570|B4|Baseline|Total|Total of all reporting groups
25192|NCT02117570|B3|Baseline|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25193|NCT02117570|B2|Baseline|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25194|NCT02117570|B1|Baseline|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25195|NCT02117570|P3|Participant Flow|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25196|NCT02117570|P2|Participant Flow|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25197|NCT02117570|P1|Participant Flow|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25198|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25199|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25200|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25440|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
25201|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25202|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25203|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25204|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25205|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25206|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25207|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25208|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25209|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25210|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25211|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25212|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25213|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25214|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25215|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25216|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25217|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25218|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25219|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25220|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25221|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25222|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25223|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25224|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25225|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25226|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25227|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25228|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25229|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25230|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25231|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25232|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25233|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25234|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25235|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25236|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25237|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25238|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25239|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25240|NCT02117570|E6|Reported Event|Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25241|NCT02117570|E5|Reported Event|Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25242|NCT02117570|E4|Reported Event|Placebo (65-85 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25243|NCT02117570|E3|Reported Event|Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25244|NCT02117570|E2|Reported Event|Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25245|NCT02117570|E1|Reported Event|Placebo (50-64 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
25246|NCT02117544|B1|Baseline|Overall|AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
25247|NCT02117544|P2|Participant Flow|AOAMF, Then New MF|Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
25248|NCT02117544|P1|Participant Flow|New MF, Then AOAMF|Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
25249|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
25250|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
25251|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
25252|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
25253|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
25254|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
25255|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
25256|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
25257|NCT02117544|E3|Reported Event|AOAMF|Includes all subjects/eyes exposed to AOAMF
25258|NCT02117544|E2|Reported Event|New MF|Includes all subjects/eyes exposed to New MF
25259|NCT02117544|E1|Reported Event|Pre-treatment|Includes all enrolled subjects/eyes prior to exposure to the investigational products
25260|NCT02117414|B3|Baseline|Total|Total of all reporting groups
25261|NCT02117414|B2|Baseline|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25262|NCT02117414|B1|Baseline|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25263|NCT02117414|P2|Participant Flow|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25264|NCT02117414|P1|Participant Flow|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25265|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25266|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25267|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25268|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25269|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25270|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25271|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25272|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25273|NCT02117414|O1|Outcome|Implanted Subjects|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
25274|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25275|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25276|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25277|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25278|NCT02117414|O1|Outcome|MRI Group|All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
25279|NCT02117414|E2|Reported Event|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
25280|NCT02117414|E1|Reported Event|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
25281|NCT02117193|B1|Baseline|All Study Participants|Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
25282|NCT02117193|P1|Participant Flow|All Study Participants|This is a cross-over study.
25283|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25284|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Normal sleep: One night of normal sleep (8h)"
25285|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep Deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25286|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
25287|NCT02117193|O4|Outcome|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
25288|NCT02117193|O3|Outcome|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
25289|NCT02117193|O2|Outcome|Alcohol Intake + Sleep Deprivation|1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation
25290|NCT02117193|O1|Outcome|Alcohol Intake + Normal Sleep|1g/kg of alcohol (beer) combined with 8 hours of normal sleep
25291|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25292|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
25293|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25294|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
25295|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25296|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
25297|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
25298|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
25299|NCT02117193|E4|Reported Event|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
25300|NCT02117193|E3|Reported Event|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
25301|NCT02117193|E2|Reported Event|Alcohol Intake + Sleep Deprivation|1 g/kg of etanol combined with 8 hours of sleep deprivation
25302|NCT02117193|E1|Reported Event|Alcohol Intake + Normal Sleep|1 g/kg of etanol combined with 8 hours of normal sleep
25303|NCT02117050|B1|Baseline|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25304|NCT02117050|P1|Participant Flow|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25305|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25306|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25307|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25308|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25309|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25310|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25311|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25312|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25313|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25314|NCT02117050|E1|Reported Event|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
25315|NCT02115984|B3|Baseline|Total|Total of all reporting groups
25316|NCT02115984|B2|Baseline|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25317|NCT02115984|B1|Baseline|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25318|NCT02115984|P2|Participant Flow|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25319|NCT02115984|P1|Participant Flow|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25320|NCT02115984|O2|Outcome|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25321|NCT02115984|O1|Outcome|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25322|NCT02115984|E2|Reported Event|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
52636|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
25323|NCT02115984|E1|Reported Event|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
25324|NCT02115815|B8|Baseline|Total|Total of all reporting groups
25325|NCT02115815|B7|Baseline|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25326|NCT02115815|B6|Baseline|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25327|NCT02115815|B5|Baseline|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25328|NCT02115815|B4|Baseline|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25329|NCT02115815|B3|Baseline|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25330|NCT02115815|B2|Baseline|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25331|NCT02115815|B1|Baseline|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25332|NCT02115815|P7|Participant Flow|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25333|NCT02115815|P6|Participant Flow|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25334|NCT02115815|P5|Participant Flow|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25335|NCT02115815|P4|Participant Flow|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25336|NCT02115815|P3|Participant Flow|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25337|NCT02115815|P2|Participant Flow|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25338|NCT02115815|P1|Participant Flow|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25339|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25340|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25341|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25342|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25343|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25344|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25345|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25346|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25347|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25348|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25349|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25350|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25351|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25352|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25353|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25354|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25355|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25356|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25357|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25358|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25359|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25360|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25361|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25362|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25363|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25364|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25365|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25366|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25367|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25368|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25369|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25370|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25371|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25372|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25373|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25374|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25375|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25376|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25377|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25378|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25379|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25380|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25381|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25382|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25383|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25384|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25385|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25386|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25387|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25388|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25389|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25390|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25391|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25392|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25393|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25394|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25395|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25396|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25397|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25635|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25398|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25399|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25400|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25401|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25402|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25403|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25404|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25405|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25406|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25407|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25408|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25409|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25410|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25411|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25412|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25413|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25414|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25415|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25416|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25417|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25418|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25419|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25420|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25421|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25422|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25423|NCT02115815|E7|Reported Event|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25424|NCT02115815|E6|Reported Event|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
25425|NCT02115815|E5|Reported Event|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25426|NCT02115815|E4|Reported Event|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
25427|NCT02115815|E3|Reported Event|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
25428|NCT02115815|E2|Reported Event|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
25429|NCT02115815|E1|Reported Event|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
25430|NCT02115581|B3|Baseline|Total|Total of all reporting groups
25431|NCT02115581|B2|Baseline|Placebo|known cases of idiopathic dilated cardiomyopathy who received the placebo
25432|NCT02115581|B1|Baseline|Conezyme Q10|known cases of idiopathic dilated cardiomyopathy who received Co Q10
25433|NCT02115581|P2|Participant Flow|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
25434|NCT02115581|P1|Participant Flow|Coenzyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
25435|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
25436|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
25437|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
25438|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
25439|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
25441|NCT02115581|E2|Reported Event|Placebo (Control Group)|"Known cases of idiopathic dilated cardiomyopathy~Placebo: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
25442|NCT02115581|E1|Reported Event|Coenzyme Q10 (Study Group)|"Known cases of idiopathic dilated cardiomyopathy~Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
25443|NCT02115321|B3|Baseline|Total|Total of all reporting groups
25444|NCT02115321|B2|Baseline|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25445|NCT02115321|B1|Baseline|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25446|NCT02115321|P2|Participant Flow|Part A: NC GZR 100 mg + EBR 50 mg|Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25447|NCT02115321|P1|Participant Flow|Part A: CP-B GZR 50 mg + EBR 50 mg|Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
25448|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25449|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25450|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25451|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25452|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25453|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25454|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25455|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25456|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25457|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25458|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25459|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25460|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25461|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25462|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25463|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25464|NCT02115321|E2|Reported Event|Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25465|NCT02115321|E1|Reported Event|CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
25466|NCT02114892|B3|Baseline|Total|Total of all reporting groups
25467|NCT02114892|B2|Baseline|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25468|NCT02114892|B1|Baseline|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25469|NCT02114892|P2|Participant Flow|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25470|NCT02114892|P1|Participant Flow|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25471|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25472|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25473|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25474|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25475|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25476|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25477|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25478|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25479|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25636|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25480|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25481|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25482|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25483|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25484|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25485|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25486|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25487|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25488|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25489|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25490|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25491|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25492|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25493|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25494|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25495|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25496|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25497|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25498|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25499|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25500|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25501|NCT02114892|E2|Reported Event|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
25502|NCT02114892|E1|Reported Event|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
25503|NCT02114268|B7|Baseline|Total|Total of all reporting groups
25504|NCT02114268|B6|Baseline|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25505|NCT02114268|B5|Baseline|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25506|NCT02114268|B4|Baseline|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25507|NCT02114268|B3|Baseline|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25508|NCT02114268|B2|Baseline|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25509|NCT02114268|B1|Baseline|Placebo|Participants received placebo on Day 1.
25510|NCT02114268|P6|Participant Flow|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25511|NCT02114268|P5|Participant Flow|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25512|NCT02114268|P4|Participant Flow|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25555|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25513|NCT02114268|P3|Participant Flow|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25514|NCT02114268|P2|Participant Flow|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25515|NCT02114268|P1|Participant Flow|Placebo|Participants received placebo on Day 1.
25516|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25517|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25518|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25519|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25520|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25521|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
25522|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25523|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25524|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25525|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25526|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25527|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25528|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25529|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25530|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25531|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25532|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25533|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25534|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25535|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25536|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25537|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25538|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25539|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25540|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25541|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25542|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25543|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25544|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25545|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25546|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25547|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25548|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25549|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25550|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25551|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25552|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25553|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25554|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25556|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25557|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
25558|NCT02114268|E6|Reported Event|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
25559|NCT02114268|E5|Reported Event|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
25560|NCT02114268|E4|Reported Event|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
25561|NCT02114268|E3|Reported Event|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
25562|NCT02114268|E2|Reported Event|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
25563|NCT02114268|E1|Reported Event|Placebo|Participants received placebo on Day 1.
25564|NCT02114216|B4|Baseline|Total|Total of all reporting groups
25565|NCT02114216|B3|Baseline|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
25566|NCT02114216|B2|Baseline|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
25567|NCT02114216|B1|Baseline|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
25568|NCT02114216|P3|Participant Flow|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
25569|NCT02114216|P2|Participant Flow|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
25570|NCT02114216|P1|Participant Flow|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
25571|NCT02114216|O3|Outcome|NERD Group|"Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
25572|NCT02114216|O2|Outcome|ERD Group|"Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
25573|NCT02114216|O1|Outcome|Control Group|"Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
25574|NCT02114216|O3|Outcome|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
25575|NCT02114216|O2|Outcome|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
25576|NCT02114216|O1|Outcome|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
25577|NCT02114216|E3|Reported Event|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
25578|NCT02114216|E2|Reported Event|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
25579|NCT02114216|E1|Reported Event|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
25580|NCT02114177|B3|Baseline|Total|Total of all reporting groups
25581|NCT02114177|B2|Baseline|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25582|NCT02114177|B1|Baseline|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25583|NCT02114177|P2|Participant Flow|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25584|NCT02114177|P1|Participant Flow|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25585|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25586|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25587|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25588|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25589|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25590|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25591|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25592|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25593|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25594|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25595|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25596|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25597|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25598|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25599|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25600|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25601|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25602|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25603|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25604|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25605|NCT02114177|E2|Reported Event|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
25606|NCT02114177|E1|Reported Event|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
25607|NCT02114151|B1|Baseline|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25608|NCT02114151|P1|Participant Flow|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25609|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25610|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25611|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25612|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25613|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25614|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25615|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25616|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25617|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25618|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25619|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25620|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25621|NCT02114151|E1|Reported Event|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
25622|NCT02113579|B3|Baseline|Total|Total of all reporting groups
25623|NCT02113579|B2|Baseline|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25624|NCT02113579|B1|Baseline|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25625|NCT02113579|P2|Participant Flow|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25626|NCT02113579|P1|Participant Flow|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25627|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25628|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25629|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25630|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25631|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25632|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25633|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
52637|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
25637|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25638|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25639|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25640|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25641|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25642|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25643|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25644|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25645|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25646|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25647|NCT02113579|E2|Reported Event|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
25648|NCT02113579|E1|Reported Event|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
25649|NCT02113449|B1|Baseline|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25650|NCT02113449|P1|Participant Flow|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25651|NCT02113449|O1|Outcome|CO2 Nasal Spray|Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
25652|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25653|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25654|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25655|NCT02113449|O1|Outcome|CO2 Nasal Spray|
25656|NCT02113449|O1|Outcome|C02 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25657|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25658|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25659|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25660|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25661|NCT02113449|O1|Outcome|All Participants|"The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."
25662|NCT02113449|E1|Reported Event|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
25663|NCT02113124|B3|Baseline|Total|Total of all reporting groups
25664|NCT02113124|B2|Baseline|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
25665|NCT02113124|B1|Baseline|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
25666|NCT02113124|P2|Participant Flow|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
25667|NCT02113124|P1|Participant Flow|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
25668|NCT02113124|O2|Outcome|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
25669|NCT02113124|O1|Outcome|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
25670|NCT02113124|E2|Reported Event|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
25671|NCT02113124|E1|Reported Event|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
25672|NCT02113007|B1|Baseline|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25749|NCT02109172|P6|Participant Flow|175mcg First, Then Placebo, Then 44mcg|175mcg once daily then placebo once daily for 7 days then Placebo inhalation solution twice daily for 7 days then 44mcg twice daily for 7 days
25673|NCT02113007|P1|Participant Flow|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25674|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25675|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25676|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25677|NCT02113007|E1|Reported Event|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
25678|NCT02111603|B1|Baseline|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25679|NCT02111603|P1|Participant Flow|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25680|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25681|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25682|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25683|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25684|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25685|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25686|NCT02111603|E1|Reported Event|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
25687|NCT02111369|B1|Baseline|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
25688|NCT02111369|P1|Participant Flow|Propranolol/Botulinum|"After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25689|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25690|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25750|NCT02109172|P5|Participant Flow|175mcg First, Then 44mcg, Then Placebo|175mcg once daily then placebo once daily for 7 days then 44mcg twice daily for 7 days then Placebo inhalation solution twice daily for 7 days
25691|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25692|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25693|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
25694|NCT02111369|E1|Reported Event|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
25695|NCT02111252|B1|Baseline|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25696|NCT02111252|P1|Participant Flow|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25697|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25698|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25699|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25700|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25701|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25702|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25703|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25704|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25705|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25706|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25707|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25708|NCT02111252|E1|Reported Event|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
25709|NCT02111083|B3|Baseline|Total|Total of all reporting groups
25710|NCT02111083|B2|Baseline|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
25711|NCT02111083|B1|Baseline|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
25712|NCT02111083|P2|Participant Flow|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
25751|NCT02109172|P4|Participant Flow|44mcg First, Then Placebo, Then 175mcg|44mcg twice daily for 7 days then Placebo inhalation solution twice daily for 7 days then 175mcg once daily then placebo once daily for 7 days
25713|NCT02111083|P1|Participant Flow|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
25714|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25715|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25716|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25717|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25718|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25719|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25720|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25721|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25722|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25723|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25724|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25725|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25726|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25727|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25728|NCT02111083|E2|Reported Event|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
25729|NCT02111083|E1|Reported Event|Insulin Lispro A|Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
25730|NCT02110238|B3|Baseline|Total|Total of all reporting groups
25731|NCT02110238|B2|Baseline|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25732|NCT02110238|B1|Baseline|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25733|NCT02110238|P2|Participant Flow|Supartz|"SUPARTZ® (hyaluronic acid of avian origin)~Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
25734|NCT02110238|P1|Participant Flow|Euflexxa|"Euflexxa® (hyaluronic acid of bacterial origin)~Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
25735|NCT02110238|O2|Outcome|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25736|NCT02110238|O1|Outcome|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25737|NCT02110238|E2|Reported Event|Supartz|SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25738|NCT02110238|E1|Reported Event|Euflexxa|Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
25739|NCT02109731|B1|Baseline|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
25740|NCT02109731|P1|Participant Flow|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
25741|NCT02109731|O1|Outcome|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
25742|NCT02109731|E1|Reported Event|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
25743|NCT02109497|B1|Baseline|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
25744|NCT02109497|P1|Participant Flow|Caffeine Dosing|Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12.
25745|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
25746|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
25747|NCT02109497|E1|Reported Event|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
25748|NCT02109172|B1|Baseline|Entire Study Population|All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
26840|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
25752|NCT02109172|P3|Participant Flow|44mcg First, Then 175mcg, Then Placebo|44mcg twice daily for 7 days then 175mcg once daily then placebo once daily for 7 days then Placebo inhalation solution twice daily for 7 days
25753|NCT02109172|P2|Participant Flow|Placebo First, Then 175mcg, Then 44mcg|Placebo inhalation solution twice daily for 7 days then 175mcg once daily then placebo once daily for 7 days then 44mcg twice daily for 7 days
25754|NCT02109172|P1|Participant Flow|Placebo First, Then 44mcg, Then 175mcg|Placebo inhalation solution twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily then placebo once daily for 7 days
25755|NCT02109172|O3|Outcome|TD-4208 175 mcg Once Daily|"TD-4208 inhalation solution 175 mcg once daily, placebo once daily~TD-4208~Placebo"
25756|NCT02109172|O2|Outcome|TD-4208 44 mcg Twice Daily|"TD-4208 inhalation solution 44 mcg twice daily for 7 days~TD-4208"
25757|NCT02109172|O1|Outcome|Placebo|"Placebo inhalation solution twice daily for 7 days~Placebo"
25758|NCT02109172|E3|Reported Event|TD-4208 175mcg Once Daily|TD-4208 inhalation solution 175 mcg once daily
25759|NCT02109172|E2|Reported Event|TD-4208 44mcg Twice Daily|TD-4208 inhalation solution 44 mcg twice daily for 7 days
25760|NCT02109172|E1|Reported Event|Placebo|Placebo inhalation solution twice daily for 7 days
25761|NCT02109159|B3|Baseline|Total|Total of all reporting groups
25762|NCT02109159|B2|Baseline|Control Video|a short online video (2”43 minutes long) about the WOMAN trial with less emotional content (the interviewer provides a second hand description of the experience)
25763|NCT02109159|B1|Baseline|Emotional Video|a short online video (2”43 minutes long) about the WOMAN trial with more emotional content (an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience)
25764|NCT02109159|P2|Participant Flow|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
25765|NCT02109159|P1|Participant Flow|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
25766|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
25767|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
25768|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
25769|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
25770|NCT02109159|E2|Reported Event|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
25771|NCT02109159|E1|Reported Event|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
25772|NCT02109133|B3|Baseline|Total|Total of all reporting groups
25773|NCT02109133|B2|Baseline|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
25774|NCT02109133|B1|Baseline|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
25775|NCT02109133|P2|Participant Flow|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
25776|NCT02109133|P1|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
25777|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
25778|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
25779|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
25780|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
25781|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
25782|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
25783|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
25784|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
25785|NCT02109133|E2|Reported Event|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
25786|NCT02109133|E1|Reported Event|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
25787|NCT02109107|B1|Baseline|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25788|NCT02109107|P1|Participant Flow|Erchonia® Zerona 6 Headed Scanner (EZ6) Laser|"The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25789|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25790|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25791|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25792|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25793|NCT02109107|E1|Reported Event|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
25794|NCT02108977|B3|Baseline|Total|Total of all reporting groups
25795|NCT02108977|B2|Baseline|Telephone Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25796|NCT02108977|B1|Baseline|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25797|NCT02108977|P2|Participant Flow|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25798|NCT02108977|P1|Participant Flow|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25799|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25800|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25801|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25802|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25803|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
26841|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
25804|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25805|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25806|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25807|NCT02108977|E2|Reported Event|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
25808|NCT02108977|E1|Reported Event|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
25809|NCT02108691|B3|Baseline|Total|Total of all reporting groups
25810|NCT02108691|B2|Baseline|Placebo|Placebo: Placebo (2.5g/day)
25811|NCT02108691|B1|Baseline|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25812|NCT02108691|P2|Participant Flow|Placebo|Placebo: Placebo (2.5g/day)
25813|NCT02108691|P1|Participant Flow|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25814|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25815|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25816|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25817|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25818|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25819|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25820|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25821|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25822|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25823|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25824|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25825|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25826|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
25827|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25828|NCT02108691|E2|Reported Event|Placebo|Placebo: Placebo (2.5g/day)
25829|NCT02108691|E1|Reported Event|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
25830|NCT02108652|B1|Baseline|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25831|NCT02108652|P1|Participant Flow|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25832|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25833|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25834|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25835|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25836|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25837|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25838|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
26842|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
25839|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25840|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25841|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25842|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25843|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25844|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25845|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25846|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25847|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25848|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25849|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25850|NCT02108652|E1|Reported Event|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
25851|NCT02108288|B4|Baseline|Total|Total of all reporting groups
25852|NCT02108288|B3|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
25853|NCT02108288|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
25854|NCT02108288|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25855|NCT02108288|P3|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
25856|NCT02108288|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
25857|NCT02108288|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25858|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
25859|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25860|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
25861|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25862|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
25863|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25864|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
25865|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25866|NCT02108288|E3|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
25867|NCT02108288|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
25868|NCT02108288|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
25869|NCT02108223|B4|Baseline|Total|Total of all reporting groups
25870|NCT02108223|B3|Baseline|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25921|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25983|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25871|NCT02108223|B2|Baseline|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25872|NCT02108223|B1|Baseline|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25873|NCT02108223|P3|Participant Flow|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25874|NCT02108223|P2|Participant Flow|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25875|NCT02108223|P1|Participant Flow|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25876|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25877|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25878|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25879|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25880|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25881|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25882|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25883|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25884|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25885|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25886|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25887|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25888|NCT02108223|O3|Outcome|r-FSH (Gonal-f) Group 3|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25889|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH Group 2|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25890|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f) Group 1|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25891|NCT02108223|E3|Reported Event|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
25952|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25892|NCT02108223|E2|Reported Event|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
25893|NCT02108223|E1|Reported Event|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
25894|NCT02108171|B3|Baseline|Total|Total of all reporting groups
25895|NCT02108171|B2|Baseline|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25896|NCT02108171|B1|Baseline|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25897|NCT02108171|P2|Participant Flow|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25898|NCT02108171|P1|Participant Flow|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25899|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25900|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25901|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25902|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25903|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25904|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25905|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25906|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25907|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25908|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25909|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25910|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25911|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25912|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25913|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25914|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25915|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25916|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25917|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25918|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25919|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25920|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
26843|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
25922|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25923|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25924|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25925|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25926|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25927|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25928|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25929|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25930|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25931|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25932|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25933|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25934|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25935|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25936|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25937|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25938|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25939|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25940|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25941|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25942|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25943|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25944|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25945|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25946|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25947|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25948|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25949|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25950|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25951|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25953|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25954|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25955|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25956|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25957|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25958|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25959|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25960|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25961|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25962|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25963|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25964|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25965|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25966|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25967|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25968|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25969|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25970|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25971|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25972|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25973|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25974|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25975|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25976|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25977|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25978|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25979|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25980|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25981|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25982|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
52638|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
25984|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25985|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25986|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25987|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25988|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25989|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25990|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25991|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25992|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25993|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25994|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25995|NCT02108171|E2|Reported Event|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25996|NCT02108171|E1|Reported Event|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
25997|NCT02107898|B3|Baseline|Total|Total of all reporting groups
25998|NCT02107898|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
25999|NCT02107898|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26000|NCT02107898|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26001|NCT02107898|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) added to stable lipid-modifying therapy (LMT) for 52 weeks.
26002|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26003|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26004|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26005|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26006|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26007|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26008|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26009|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26010|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26011|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26012|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26013|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26014|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26015|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26016|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26017|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26018|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26019|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26020|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26021|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26022|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26023|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26024|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26025|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26026|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26027|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26028|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26029|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26030|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26031|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26032|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26033|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26034|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26035|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26036|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26037|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26038|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26039|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26040|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26041|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26042|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26043|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26044|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26045|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26046|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26047|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26048|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
26049|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
26050|NCT02107898|E2|Reported Event|Alirocumab 75 mg/ Up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
26051|NCT02107898|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
26052|NCT02107599|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
26053|NCT02107599|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
26054|NCT02107599|O3|Outcome|Non-autopsy Cases|Only 50 non-autopsy scans from A17.
26055|NCT02107599|O2|Outcome|Autopsy Cases|Only 46 autopsy scans from A16.
26056|NCT02107599|O1|Outcome|All Study Cases|All 96 scans from A16 and A17.
26057|NCT02107599|O1|Outcome|Physician Readers|All 21 physician readers.
26058|NCT02107599|E1|Reported Event|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
26059|NCT02107339|B3|Baseline|Total|Total of all reporting groups
26060|NCT02107339|B2|Baseline|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26061|NCT02107339|B1|Baseline|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26062|NCT02107339|P2|Participant Flow|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26063|NCT02107339|P1|Participant Flow|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26064|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26065|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26066|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26067|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26068|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26069|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26070|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26071|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26072|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26073|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26074|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26075|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26076|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26077|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26078|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26079|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26080|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26081|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26082|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26083|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26084|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26085|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26086|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26087|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26088|NCT02107339|E2|Reported Event|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
26089|NCT02107339|E1|Reported Event|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
26090|NCT02107313|B1|Baseline|All Study Participants|Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food.
26091|NCT02107313|P2|Participant Flow|Fasted Cohort First Then Fed Cohort|"Per sequence, FASTED Cohort first, then FED Cohort.~Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort."
26092|NCT02107313|P1|Participant Flow|Fed Cohort First Then Fasted Cohort|"Per sequence, FED Cohort first then FASTED Cohort.~Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort."
26093|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
26094|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
26095|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
26096|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
26097|NCT02107313|E2|Reported Event|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
26098|NCT02107313|E1|Reported Event|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
26099|NCT02107274|B3|Baseline|Total|Total of all reporting groups
26100|NCT02107274|B2|Baseline|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26101|NCT02107274|B1|Baseline|Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26102|NCT02107274|P2|Participant Flow|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26103|NCT02107274|P1|Participant Flow|Azithromycin and Placebo for Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26104|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26105|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26106|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26107|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26108|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26109|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26110|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26111|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26112|NCT02107274|E2|Reported Event|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26113|NCT02107274|E1|Reported Event|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
26114|NCT02107196|B3|Baseline|Total|Total of all reporting groups
26115|NCT02107196|B2|Baseline|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26116|NCT02107196|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26117|NCT02107196|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the placebo arm will be mock-re-randomized (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26118|NCT02107196|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the ibodutant 10 mg arm will be re-randomized at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26119|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26120|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26121|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26122|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26123|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26124|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26125|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26126|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26127|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26128|NCT02107196|E2|Reported Event|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
26129|NCT02107196|E1|Reported Event|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
26130|NCT02106728|B3|Baseline|Total|Total of all reporting groups
26131|NCT02106728|B2|Baseline|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26169|NCT02106403|P2|Participant Flow|Sequence 2|Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
26132|NCT02106728|B1|Baseline|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26133|NCT02106728|P2|Participant Flow|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26134|NCT02106728|P1|Participant Flow|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26135|NCT02106728|O6|Outcome|Supportive Family Therapy (Approximately 10 WEEKS)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26136|NCT02106728|O5|Outcome|Multi-Family Therapy (8WEEKS)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26137|NCT02106728|O4|Outcome|Supportive Family Therapy (POST)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26138|NCT02106728|O3|Outcome|Multi-Family Therapy (POST)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26139|NCT02106728|O2|Outcome|Supportive Family Therapy (PRE)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26140|NCT02106728|O1|Outcome|Multi-Family Therapy (PRE)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26141|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26142|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26143|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26144|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26145|NCT02106728|E2|Reported Event|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
26146|NCT02106728|E1|Reported Event|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
26147|NCT02106494|B3|Baseline|Total|Total of all reporting groups
26148|NCT02106494|B2|Baseline|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26149|NCT02106494|B1|Baseline|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26150|NCT02106494|P2|Participant Flow|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26151|NCT02106494|P1|Participant Flow|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26152|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26153|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26154|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26155|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26156|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26157|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26158|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26159|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
26160|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26161|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26162|NCT02106494|E2|Reported Event|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26163|NCT02106494|E1|Reported Event|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
26164|NCT02106403|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
26165|NCT02106403|P6|Participant Flow|Sequence 6|Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
26166|NCT02106403|P5|Participant Flow|Sequence 5|Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
26167|NCT02106403|P4|Participant Flow|Sequence 4|Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
26168|NCT02106403|P3|Participant Flow|Sequence 3|Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
26170|NCT02106403|P1|Participant Flow|Sequence 1|Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
26171|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26172|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26173|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26174|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26175|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26176|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26177|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26178|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26179|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound
26180|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26181|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26182|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26183|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26184|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26185|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26186|NCT02106403|E3|Reported Event|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26187|NCT02106403|E2|Reported Event|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26188|NCT02106403|E1|Reported Event|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
26189|NCT02106156|B4|Baseline|Total|Total of all reporting groups
26190|NCT02106156|B3|Baseline|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
26191|NCT02106156|B2|Baseline|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26192|NCT02106156|B1|Baseline|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26193|NCT02106156|P3|Participant Flow|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
26194|NCT02106156|P2|Participant Flow|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
26195|NCT02106156|P1|Participant Flow|Main Analysis Set|Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
26196|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26197|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26198|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26199|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26200|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26201|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26202|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26203|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26204|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26205|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26206|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26207|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26208|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26209|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26210|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26211|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
26212|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26213|NCT02106156|E3|Reported Event|Elastography Analysis Set: Untreated|Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
26214|NCT02106156|E2|Reported Event|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
26215|NCT02106156|E1|Reported Event|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
26216|NCT02105987|B3|Baseline|Total|Total of all reporting groups
26217|NCT02105987|B2|Baseline|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26218|NCT02105987|B1|Baseline|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26219|NCT02105987|P6|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
26844|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
26220|NCT02105987|P5|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
26221|NCT02105987|P4|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch|Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26222|NCT02105987|P3|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch|Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.
26223|NCT02105987|P2|Participant Flow|Current ART|Participants continued on their current ART regimen for 24 weeks.
26224|NCT02105987|P1|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.
26225|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26226|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26227|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26228|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26229|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26230|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26231|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26232|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26233|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26234|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26235|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26236|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26237|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26238|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26239|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26240|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26241|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26242|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26243|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26244|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26245|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26246|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26247|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26248|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26249|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26250|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26251|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26252|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26253|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26254|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26255|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26256|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26257|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26258|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26259|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26260|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26261|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26262|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26263|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26264|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26315|NCT02105701|E3|Reported Event|GZR/EBR 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26845|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
26265|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26266|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26267|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26268|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26269|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26270|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26271|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26272|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26273|NCT02105987|E2|Reported Event|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
26274|NCT02105987|E1|Reported Event|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
26275|NCT02105974|B3|Baseline|Total|Total of all reporting groups
26276|NCT02105974|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26277|NCT02105974|B1|Baseline|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26278|NCT02105974|P3|Participant Flow|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26279|NCT02105974|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26280|NCT02105974|P1|Participant Flow|Placebo Run-In|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
26281|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26282|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26283|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26284|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26543|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26285|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26286|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26287|NCT02105974|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26288|NCT02105974|E1|Reported Event|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
26289|NCT02105701|B5|Baseline|Total|Total of all reporting groups
26290|NCT02105701|B4|Baseline|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26291|NCT02105701|B3|Baseline|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26292|NCT02105701|B2|Baseline|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26293|NCT02105701|B1|Baseline|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26294|NCT02105701|P4|Participant Flow|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26295|NCT02105701|P3|Participant Flow|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26296|NCT02105701|P2|Participant Flow|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26297|NCT02105701|P1|Participant Flow|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26298|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26299|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26300|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26301|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26302|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26303|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26304|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26305|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26306|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26307|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26308|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26309|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26310|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26311|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
26312|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26313|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26314|NCT02105701|E4|Reported Event|GZR/EBR + RBV for 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
26316|NCT02105701|E2|Reported Event|GZR/EBR + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
26317|NCT02105701|E1|Reported Event|GZR/EBR 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
26318|NCT02105688|B3|Baseline|Total|Total of all reporting groups
26319|NCT02105688|B2|Baseline|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
26320|NCT02105688|B1|Baseline|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26321|NCT02105688|P2|Participant Flow|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
26322|NCT02105688|P1|Participant Flow|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26323|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
26324|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26325|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
26326|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26327|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
26328|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26329|NCT02105688|E2|Reported Event|Deferred Treatment Arm (Placebo)|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.
26330|NCT02105688|E1|Reported Event|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
26331|NCT02105662|B1|Baseline|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26332|NCT02105662|P1|Participant Flow|Grazoprevir+Elbasvir|Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26333|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26334|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26335|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26336|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26337|NCT02105662|E1|Reported Event|Grazoprevir + Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
26338|NCT02105636|B3|Baseline|Total|Total of all reporting groups
26339|NCT02105636|B2|Baseline|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
26340|NCT02105636|B1|Baseline|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26341|NCT02105636|P2|Participant Flow|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
26342|NCT02105636|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26343|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigator's Choice.
26344|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26345|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
26346|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26347|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
26348|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26349|NCT02105636|E2|Reported Event|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
26350|NCT02105636|E1|Reported Event|Nivolumab 3 mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
26351|NCT02105467|B3|Baseline|Total|Total of all reporting groups
26352|NCT02105467|B2|Baseline|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
26353|NCT02105467|B1|Baseline|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26354|NCT02105467|P2|Participant Flow|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
26355|NCT02105467|P1|Participant Flow|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
26356|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26357|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26358|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
26359|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26360|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
26361|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26362|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
26363|NCT02105467|E3|Reported Event|Deferred Treatment Group (Open-label Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
26364|NCT02105467|E2|Reported Event|Deferred Treatment Group (Blinded Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
26365|NCT02105467|E1|Reported Event|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
26366|NCT02105454|B1|Baseline|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26544|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26367|NCT02105454|P1|Participant Flow|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26368|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26369|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26370|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26371|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26372|NCT02105454|E1|Reported Event|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
26373|NCT02105285|B4|Baseline|Total|Total of all reporting groups
26374|NCT02105285|B3|Baseline|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
26375|NCT02105285|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26376|NCT02105285|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26377|NCT02105285|P3|Participant Flow|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
26378|NCT02105285|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26379|NCT02105285|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26380|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26381|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26382|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26383|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26384|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26385|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26386|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26387|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26388|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26389|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26390|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26391|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26392|NCT02105285|E3|Reported Event|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
26393|NCT02105285|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
26394|NCT02105285|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26395|NCT02105272|B3|Baseline|Total|Total of all reporting groups
26396|NCT02105272|B2|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26397|NCT02105272|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26398|NCT02105272|P2|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26399|NCT02105272|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26400|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26401|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26402|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26403|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26404|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26405|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26406|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26407|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26408|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26409|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26410|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26411|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26412|NCT02105272|E2|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
26413|NCT02105272|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
26414|NCT02104895|B3|Baseline|Total|Total of all reporting groups
26415|NCT02104895|B2|Baseline|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26416|NCT02104895|B1|Baseline|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26417|NCT02104895|P2|Participant Flow|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26418|NCT02104895|P1|Participant Flow|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26419|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26420|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26421|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26422|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26423|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26424|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26425|NCT02104895|E2|Reported Event|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
26426|NCT02104895|E1|Reported Event|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
26427|NCT02104830|B4|Baseline|Total|Total of all reporting groups
26428|NCT02104830|B3|Baseline|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26429|NCT02104830|B2|Baseline|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.~empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.~Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg."
26430|NCT02104830|B1|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26431|NCT02104830|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26432|NCT02104830|P2|Participant Flow|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26433|NCT02104830|P1|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26434|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26435|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26436|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26437|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26438|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26439|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26440|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26441|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26442|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26443|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26444|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26445|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26446|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26447|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26448|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26449|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26450|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26451|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26452|NCT02104830|E3|Reported Event|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
26453|NCT02104830|E2|Reported Event|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26454|NCT02104830|E1|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
26455|NCT02104219|B1|Baseline|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26456|NCT02104219|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26457|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26458|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26459|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26460|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26545|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26461|NCT02104219|E1|Reported Event|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
26462|NCT02103439|B3|Baseline|Total|Total of all reporting groups
26463|NCT02103439|B2|Baseline|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26464|NCT02103439|B1|Baseline|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26465|NCT02103439|P2|Participant Flow|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26466|NCT02103439|P1|Participant Flow|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26467|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26468|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26469|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26470|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26471|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26472|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26473|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26474|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26475|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26476|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26477|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26478|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26479|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26480|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26846|NCT02099682|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
26481|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
26482|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26483|NCT02103439|E2|Reported Event|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week~The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [previous treatment of hepatitis C with interferon alfa], who was withdrawn from the mITT-analysis)"
26484|NCT02103439|E1|Reported Event|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
26485|NCT02103309|B1|Baseline|Overall|DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
26486|NCT02103309|P2|Participant Flow|1DAM, Then DACP|Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26487|NCT02103309|P1|Participant Flow|DACP, Then 1DAM|Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26488|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26489|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26490|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26491|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26492|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26493|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26494|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26495|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26496|NCT02103309|E2|Reported Event|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26497|NCT02103309|E1|Reported Event|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
26498|NCT02103062|B3|Baseline|Total|Total of all reporting groups
26499|NCT02103062|B2|Baseline|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26500|NCT02103062|B1|Baseline|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26501|NCT02103062|P2|Participant Flow|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26502|NCT02103062|P1|Participant Flow|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26503|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26504|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26505|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26506|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26507|NCT02103062|O2|Outcome|RAS Mutated Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26508|NCT02103062|O1|Outcome|RAS Wildtype Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26509|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26510|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26511|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26512|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26513|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26847|NCT02099461|B4|Baseline|Total|Total of all reporting groups
26514|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26515|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26516|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26517|NCT02103062|E2|Reported Event|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26518|NCT02103062|E1|Reported Event|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
26519|NCT02102932|B9|Baseline|Total|Total of all reporting groups
26520|NCT02102932|B8|Baseline|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
26521|NCT02102932|B7|Baseline|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
26522|NCT02102932|B6|Baseline|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
26523|NCT02102932|B5|Baseline|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
26524|NCT02102932|B4|Baseline|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
26525|NCT02102932|B3|Baseline|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
26526|NCT02102932|B2|Baseline|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
26527|NCT02102932|B1|Baseline|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
26528|NCT02102932|P8|Participant Flow|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
26529|NCT02102932|P7|Participant Flow|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
26530|NCT02102932|P6|Participant Flow|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
26531|NCT02102932|P5|Participant Flow|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
26532|NCT02102932|P4|Participant Flow|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
26533|NCT02102932|P3|Participant Flow|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
26534|NCT02102932|P2|Participant Flow|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
26535|NCT02102932|P1|Participant Flow|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
26536|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26537|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26538|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26539|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26540|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26541|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26542|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26546|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26547|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26548|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26549|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26550|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26551|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26552|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26553|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26554|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26555|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26556|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26557|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26558|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26559|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26560|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26561|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26562|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26563|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26564|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26565|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26566|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26567|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26568|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26569|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26570|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26571|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26572|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26573|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26574|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26575|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26576|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26577|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26578|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26579|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26580|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26581|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26582|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26583|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26584|NCT02102932|E8|Reported Event|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
26585|NCT02102932|E7|Reported Event|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
26586|NCT02102932|E6|Reported Event|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
26587|NCT02102932|E5|Reported Event|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
26588|NCT02102932|E4|Reported Event|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
26589|NCT02102932|E3|Reported Event|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
26590|NCT02102932|E2|Reported Event|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
26591|NCT02102932|E1|Reported Event|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
26592|NCT02102399|B3|Baseline|Total|Total of all reporting groups
26593|NCT02102399|B2|Baseline|Respiratory Muscle Training|Respiratory Muscle Training group was performed during 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26594|NCT02102399|B1|Baseline|Vocal Warm-up|Vocal Warm up group was performed during 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26595|NCT02102399|P2|Participant Flow|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26596|NCT02102399|P1|Participant Flow|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26597|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26598|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26599|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26600|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26601|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26602|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26603|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26604|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26605|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26606|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26607|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26608|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26609|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26610|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26611|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26612|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26613|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
26614|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26615|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26616|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26617|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26618|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26619|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26620|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26621|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26622|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26623|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26624|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26625|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26626|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26627|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26628|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26629|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26630|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26631|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26632|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26633|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26634|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26635|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26636|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
26637|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26638|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26639|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26640|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26641|NCT02102399|E2|Reported Event|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
26642|NCT02102399|E1|Reported Event|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
26643|NCT02101359|B3|Baseline|Total|Total of all reporting groups
26644|NCT02101359|B2|Baseline|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
26645|NCT02101359|B1|Baseline|T2380|T2380: Intracameral administration during surgery
26646|NCT02101359|P2|Participant Flow|Reference Group|Mydriatics and anesthetics: Topical treatments used the day of surgery
26647|NCT02101359|P1|Participant Flow|T2380|T2380: Intracameral administration during surgery
26648|NCT02101359|O2|Outcome|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
26649|NCT02101359|O1|Outcome|T2380|T2380: Intracameral administration during surgery
26650|NCT02101359|E2|Reported Event|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
26651|NCT02101359|E1|Reported Event|T2380|T2380: Intracameral administration during surgery
26652|NCT02101294|B1|Baseline|Interossei Lumbricals Neuro Interface|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
26653|NCT02101294|P1|Participant Flow|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
26654|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the FingerRelief keyboard.
26655|NCT02101294|O1|Outcome|Length of Time Typing With FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the FingerRelief keyboard prior to stopping, averaged across two typing sessions.
26694|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26656|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the QWERTY keyboard.
26657|NCT02101294|O1|Outcome|Length of Time Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
26658|NCT02101294|E1|Reported Event|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
26659|NCT02101190|B3|Baseline|Total|Total of all reporting groups
26660|NCT02101190|B2|Baseline|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26661|NCT02101190|B1|Baseline|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26662|NCT02101190|P2|Participant Flow|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26663|NCT02101190|P1|Participant Flow|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26664|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26665|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26666|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26667|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26668|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26669|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26670|NCT02101190|E2|Reported Event|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26671|NCT02101190|E1|Reported Event|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
26672|NCT02101112|B1|Baseline|Apixaban, 10 mg (Whole Tablets)|This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
26673|NCT02101112|P6|Participant Flow|Treatment C Then Treatment B Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26674|NCT02101112|P5|Participant Flow|Treatment C Then Treatment A Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26695|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26696|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26697|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26698|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
27399|NCT02093923|O4|Outcome|Placebo|Placebo administered twice, two weeks apart
26675|NCT02101112|P4|Participant Flow|Treatment B Then Treatment A Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26676|NCT02101112|P3|Participant Flow|Treatment B Then Treatment C Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26677|NCT02101112|P2|Participant Flow|Treatment A Then Treatment C Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26678|NCT02101112|P1|Participant Flow|Treatment A Then Treatment B Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
26679|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26680|NCT02101112|O1|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26681|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26682|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26683|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26684|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26685|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26686|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26687|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26688|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26689|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26690|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26691|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26692|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26693|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26699|NCT02101112|E3|Reported Event|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
26700|NCT02101112|E2|Reported Event|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
26701|NCT02101112|E1|Reported Event|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
26702|NCT02101008|B1|Baseline|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
26703|NCT02101008|P1|Participant Flow|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
26704|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
26705|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
26706|NCT02101008|E1|Reported Event|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
26707|NCT02100839|B3|Baseline|Total|Total of all reporting groups
26708|NCT02100839|B2|Baseline|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26709|NCT02100839|B1|Baseline|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26710|NCT02100839|P2|Participant Flow|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26711|NCT02100839|P1|Participant Flow|Apolipoprotein E Mimetic (AEM)-28|"Single Ascending Dose (SAD): Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose (MAD): Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26712|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26713|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26714|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26715|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26716|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26717|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26718|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26719|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26720|NCT02100839|E2|Reported Event|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
26721|NCT02100839|E1|Reported Event|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
26722|NCT02100826|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
26723|NCT02100826|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
26724|NCT02100826|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
26725|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
26726|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
26727|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
26728|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
26729|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
26730|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
26731|NCT02100826|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
26732|NCT02100826|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
26733|NCT02100644|B1|Baseline|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
26734|NCT02100644|P3|Participant Flow|Maintenance Phase: LTG Plus VPA|Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
26735|NCT02100644|P2|Participant Flow|Reduction Phase: LTG Plus VPA|Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks.
26736|NCT02100644|P1|Participant Flow|Escalation Phase: LTG Plus VPA|Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks.
26737|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26738|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26739|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26740|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26741|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26742|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26743|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26744|NCT02100644|E1|Reported Event|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
26745|NCT02100579|B3|Baseline|Total|Total of all reporting groups
26746|NCT02100579|B2|Baseline|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26747|NCT02100579|B1|Baseline|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26748|NCT02100579|P2|Participant Flow|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26749|NCT02100579|P1|Participant Flow|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26750|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26751|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26752|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26753|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26754|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26755|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26756|NCT02100579|E2|Reported Event|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
26757|NCT02100579|E1|Reported Event|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
26759|NCT02100475|B2|Baseline|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26760|NCT02100475|B1|Baseline|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26761|NCT02100475|P2|Participant Flow|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26762|NCT02100475|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26763|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26764|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26765|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26766|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26767|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26768|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26769|NCT02100475|E2|Reported Event|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26770|NCT02100475|E1|Reported Event|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
26771|NCT02100410|B1|Baseline|Overall|All treatment sequences
26772|NCT02100410|P6|Participant Flow|Sequence 6|T5 and T6; T3 and T4; T1 and T2
26773|NCT02100410|P5|Participant Flow|Sequence 5|T5 and T6; T1 and T2; T3 and T4
26774|NCT02100410|P4|Participant Flow|Sequence 4|T3 and T4; T5 and T6; T1 and T2
26775|NCT02100410|P3|Participant Flow|Sequence 3|T3 and T4; T1 and T2; T5 and T6
26776|NCT02100410|P2|Participant Flow|Sequence 2|T1 and T2; T5 and T6; T3 and T4
26777|NCT02100410|P1|Participant Flow|Sequence 1|T1 and T2; T3 and T4; T5 and T6
26778|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
26779|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
26780|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
26790|NCT02100410|E2|Reported Event|TEST (2,4,6)|Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
26791|NCT02100410|E1|Reported Event|TEST (1,3,5)|Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye
26792|NCT02099838|B3|Baseline|Total|Total of all reporting groups
26793|NCT02099838|B2|Baseline|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26794|NCT02099838|B1|Baseline|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26795|NCT02099838|P2|Participant Flow|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26796|NCT02099838|P1|Participant Flow|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26797|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26798|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26799|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26800|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26801|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26802|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26803|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26804|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26805|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26806|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26807|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26808|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26809|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26810|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26909|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26811|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26812|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26813|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26814|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26815|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26816|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26817|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26818|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26819|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26820|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26821|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26822|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26823|NCT02099838|E2|Reported Event|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
26824|NCT02099838|E1|Reported Event|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
26825|NCT02099708|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26826|NCT02099708|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26827|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26828|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26829|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26830|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26831|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26832|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26833|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26834|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26835|NCT02099708|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
26836|NCT02099682|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
26837|NCT02099682|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
26848|NCT02099461|B3|Baseline|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26849|NCT02099461|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26850|NCT02099461|B1|Baseline|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26851|NCT02099461|P3|Participant Flow|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26852|NCT02099461|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26853|NCT02099461|P1|Participant Flow|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26854|NCT02099461|O3|Outcome|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26855|NCT02099461|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26856|NCT02099461|O1|Outcome|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26857|NCT02099461|E3|Reported Event|Treatment C 120 MG SC|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26858|NCT02099461|E2|Reported Event|Treatment B 60 MG SC|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26859|NCT02099461|E1|Reported Event|Treatment A No Treatment|Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
26860|NCT02099344|B3|Baseline|Total|Total of all reporting groups
26861|NCT02099344|B2|Baseline|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26862|NCT02099344|B1|Baseline|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26863|NCT02099344|P2|Participant Flow|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26864|NCT02099344|P1|Participant Flow|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26865|NCT02099344|O2|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26866|NCT02099344|O1|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26867|NCT02099344|E2|Reported Event|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26868|NCT02099344|E1|Reported Event|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
26869|NCT02099084|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Teduglutide first.
26870|NCT02099084|P2|Participant Flow|Placebo First, Then Teduglutide|Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
26871|NCT02099084|P1|Participant Flow|Teduglutide First, Then Placebo|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
26872|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26873|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26874|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26875|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26876|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26877|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26878|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26879|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26880|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26881|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26882|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26883|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26884|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26885|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26886|NCT02099084|E2|Reported Event|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
26887|NCT02099084|E1|Reported Event|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
26888|NCT02099006|B1|Baseline|All Study Participants|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
26889|NCT02099006|P1|Participant Flow|All Study Participants|"Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
26890|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
26891|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
26892|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
26893|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
26894|NCT02099006|E2|Reported Event|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
26895|NCT02099006|E1|Reported Event|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
26896|NCT02098746|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26897|NCT02098746|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26898|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26899|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26900|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26901|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26902|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26903|NCT02098746|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
26904|NCT02098733|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26905|NCT02098733|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26906|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26907|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26908|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
27635|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
26910|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26911|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26912|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26913|NCT02098733|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
26914|NCT02098395|B5|Baseline|Total|Total of all reporting groups
26915|NCT02098395|B4|Baseline|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26916|NCT02098395|B3|Baseline|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26917|NCT02098395|B2|Baseline|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26918|NCT02098395|B1|Baseline|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26919|NCT02098395|P4|Participant Flow|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26920|NCT02098395|P3|Participant Flow|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26921|NCT02098395|P2|Participant Flow|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26922|NCT02098395|P1|Participant Flow|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26923|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26924|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26925|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26926|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26927|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26928|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26929|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26930|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26931|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26932|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26933|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26934|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26935|NCT02098395|E4|Reported Event|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
26936|NCT02098395|E3|Reported Event|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26937|NCT02098395|E2|Reported Event|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
26938|NCT02098395|E1|Reported Event|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
26939|NCT02098304|B1|Baseline|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device~Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System"
26940|NCT02098304|P1|Participant Flow|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
26941|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System"
26942|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
26943|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
26944|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
26945|NCT02098304|E1|Reported Event|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
26946|NCT02097745|B1|Baseline|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26947|NCT02097745|P1|Participant Flow|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26948|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26949|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26950|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26951|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26952|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26975|NCT02097719|E2|Reported Event|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
26953|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26954|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26955|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26956|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26957|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26958|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26959|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26960|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26961|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26962|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26963|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26964|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26965|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26966|NCT02097745|E2|Reported Event|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
26967|NCT02097745|E1|Reported Event|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
26968|NCT02097719|B3|Baseline|Total|Total of all reporting groups
26969|NCT02097719|B2|Baseline|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
26970|NCT02097719|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
26971|NCT02097719|P2|Participant Flow|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
26972|NCT02097719|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
26973|NCT02097719|O2|Outcome|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
26974|NCT02097719|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
27636|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
26976|NCT02097719|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
26977|NCT02097537|B1|Baseline|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26978|NCT02097537|P1|Participant Flow|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26979|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26980|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26981|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26982|NCT02097537|E1|Reported Event|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
26983|NCT02097108|B1|Baseline|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26984|NCT02097108|P1|Participant Flow|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26985|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26986|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26987|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26988|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26989|NCT02097108|E1|Reported Event|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
26990|NCT02097056|B1|Baseline|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26991|NCT02097056|P1|Participant Flow|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26992|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26993|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26994|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26995|NCT02097056|E1|Reported Event|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
26996|NCT02097030|B3|Baseline|Total|Total of all reporting groups
26997|NCT02097030|B2|Baseline|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
26998|NCT02097030|B1|Baseline|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
26999|NCT02097030|P2|Participant Flow|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
27000|NCT02097030|P1|Participant Flow|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
27001|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27002|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27003|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27004|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27005|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27006|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27007|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27008|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27009|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27010|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27011|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27012|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27013|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27014|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27015|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27016|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27017|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27018|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27019|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27020|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27021|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27022|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27023|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27024|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27025|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27026|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27027|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27028|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27029|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27030|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27031|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27032|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27033|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27034|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27035|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27036|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27037|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27038|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27039|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27040|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27041|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27042|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27043|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27044|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27045|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27046|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27637|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
27047|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27048|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27049|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27050|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27051|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27052|NCT02097030|O2|Outcome|Filcon II 3|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
27053|NCT02097030|O1|Outcome|Hydrogel|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
27054|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27055|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27056|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27057|NCT02097030|E3|Reported Event|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27058|NCT02097030|E2|Reported Event|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27059|NCT02097030|E1|Reported Event|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
27060|NCT02096835|B4|Baseline|Total|Total of all reporting groups
27061|NCT02096835|B3|Baseline|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27062|NCT02096835|B2|Baseline|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27063|NCT02096835|B1|Baseline|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27064|NCT02096835|P3|Participant Flow|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27065|NCT02096835|P2|Participant Flow|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27066|NCT02096835|P1|Participant Flow|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27067|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27068|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27083|NCT02096744|P2|Participant Flow|Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol|Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
27157|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27069|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27070|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27071|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27072|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27073|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27074|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27075|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27076|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27077|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27078|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27079|NCT02096835|E3|Reported Event|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
27080|NCT02096835|E2|Reported Event|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
27081|NCT02096835|E1|Reported Event|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
27082|NCT02096744|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch.~In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1)."
27156|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
52639|NCT01877720|E2|Reported Event|NIV-PS|non-invasive PS
27084|NCT02096744|P1|Participant Flow|Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex|Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
27085|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
27086|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
27087|NCT02096744|O2|Outcome|Catapres-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex™ (R1)
27088|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
27089|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
27090|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
27091|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
27092|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
27093|NCT02096744|E3|Reported Event|TTS-1: Vistanex™ (R2) + Oppanol® (T2)|Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™
27094|NCT02096744|E2|Reported Event|TTS-3: Vistanex™ (R1)|Administration of TTS-3 with Vistanex™
27095|NCT02096744|E1|Reported Event|TTS-3: Oppanol® (T1)|Administration of TTS-3 with Oppanol®
27096|NCT02096731|B3|Baseline|Total|Total of all reporting groups
27097|NCT02096731|B2|Baseline|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
27098|NCT02096731|B1|Baseline|Tiotropium|Participants who were new users of tiotropium.
27099|NCT02096731|P2|Participant Flow|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
27100|NCT02096731|P1|Participant Flow|Tiotropium|Participants who were new users of tiotropium.
27101|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
27102|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long- acting bronchodilator.
27103|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
27104|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long-acting bronchodilator.
27105|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
27106|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
27107|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
27108|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
27109|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
27110|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
27111|NCT02096731|E2|Reported Event|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
27112|NCT02096731|E1|Reported Event|Tiotropium|Participants who were new users of tiotropium.
27113|NCT02096718|B4|Baseline|Total|Total of all reporting groups
27114|NCT02096718|B3|Baseline|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
27115|NCT02096718|B2|Baseline|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27116|NCT02096718|B1|Baseline|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27117|NCT02096718|P3|Participant Flow|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
27118|NCT02096718|P2|Participant Flow|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27119|NCT02096718|P1|Participant Flow|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27120|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
27121|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
27122|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27123|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27124|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
27125|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
27126|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27127|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27128|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
27129|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
27130|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27131|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27132|NCT02096718|E3|Reported Event|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
27133|NCT02096718|E2|Reported Event|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
27134|NCT02096718|E1|Reported Event|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
27135|NCT02096692|B1|Baseline|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27136|NCT02096692|P1|Participant Flow|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27137|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27138|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27139|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27140|NCT02096692|E1|Reported Event|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
27141|NCT02096679|B1|Baseline|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27142|NCT02096679|P1|Participant Flow|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27143|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27144|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27145|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27146|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27147|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27148|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27149|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27150|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27151|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27152|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27153|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27154|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27155|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27158|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27159|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27160|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27161|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27162|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27163|NCT02096679|E1|Reported Event|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
27164|NCT02096575|B3|Baseline|Total|Total of all reporting groups
27165|NCT02096575|B2|Baseline|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27166|NCT02096575|B1|Baseline|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
27167|NCT02096575|P3|Participant Flow|Excluded|Participants that were withdrawn from the study after consent
27168|NCT02096575|P2|Participant Flow|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27169|NCT02096575|P1|Participant Flow|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
27170|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27171|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
27172|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27173|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
27174|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27175|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
27176|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27177|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
27178|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27179|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
27180|NCT02096575|E2|Reported Event|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
27181|NCT02096575|E1|Reported Event|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
27182|NCT02096458|B1|Baseline|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
27183|NCT02096458|P1|Participant Flow|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
27184|NCT02096458|O1|Outcome|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
27185|NCT02096458|E1|Reported Event|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
27186|NCT02095691|B1|Baseline|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
27187|NCT02095691|P1|Participant Flow|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
27188|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP reduction at 12 months follow up
27189|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP reduction at 6 months follow up
27190|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP reduction at 3 months follow up
27191|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP reduction at 1 month follow up
27192|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP at 12 months follow up
27193|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP at 6 months follow up
27194|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP at 3 months follow up
27195|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP at 1 month follow up
27196|NCT02095691|O4|Outcome|Change in Blood Pressure at 12 Month Follow Up|Change in Blood Pressure from baseline to 12 months follow up
27197|NCT02095691|O3|Outcome|Change in Blood Pressure at 6 Months Follow Up|Change in Blood Pressure from baseline to 6 months follow up
27198|NCT02095691|O2|Outcome|Change in Blood Pressure at 3 Months Follow Up|Change in Blood Pressure from baseline to3 months follow up
27199|NCT02095691|O1|Outcome|Change in Blood Pressure at 1 Month Follow up|Change in Blood Pressure from baseline to1 month follow up
27200|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
27201|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
27397|NCT02093923|P2|Participant Flow|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
52640|NCT01877720|E1|Reported Event|NIV-NAVA|non-invasive NAVA
27202|NCT02095691|E1|Reported Event|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
27203|NCT02095561|B3|Baseline|Total|Total of all reporting groups
27204|NCT02095561|B2|Baseline|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27205|NCT02095561|B1|Baseline|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27206|NCT02095561|P2|Participant Flow|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27207|NCT02095561|P1|Participant Flow|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27208|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27209|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27210|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27211|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27212|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27213|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27214|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27215|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27216|NCT02095561|E2|Reported Event|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
27217|NCT02095561|E1|Reported Event|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
27218|NCT02095223|B3|Baseline|Total|Total of all reporting groups
27219|NCT02095223|B2|Baseline|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
27220|NCT02095223|B1|Baseline|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
27221|NCT02095223|P2|Participant Flow|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
27240|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27398|NCT02093923|P1|Participant Flow|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27222|NCT02095223|P1|Participant Flow|Electromyographic Biofeedback Group|"Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest."
27223|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
27224|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
27225|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
27226|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
27227|NCT02095223|E2|Reported Event|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
27228|NCT02095223|E1|Reported Event|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
27229|NCT02095158|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
27230|NCT02095158|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
27231|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
27232|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
27233|NCT02095158|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
27234|NCT02094937|B1|Baseline|Period 1- FF/VI 100/25 mcg OD|Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
27235|NCT02094937|P4|Participant Flow|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27236|NCT02094937|P3|Participant Flow|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27237|NCT02094937|P2|Participant Flow|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27238|NCT02094937|P1|Participant Flow|FF/VI 100/25 mcg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
27239|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27392|NCT02093923|B2|Baseline|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
61190|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
27241|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27242|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27243|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27244|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27245|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27246|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27247|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27248|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27249|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27250|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27251|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27252|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27253|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27254|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27255|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27256|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27257|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27258|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27259|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27260|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27261|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27262|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27263|NCT02094937|E4|Reported Event|FP 250 mcg BD Period 2|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27264|NCT02094937|E3|Reported Event|FP 100 mcg BD Period 2|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27265|NCT02094937|E2|Reported Event|FF 100 mcg OD Period 2|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
27266|NCT02094937|E1|Reported Event|FF/VI 100/25 mcg OD Period 1|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
27267|NCT02094885|B3|Baseline|Total|Total of all reporting groups
27268|NCT02094885|B2|Baseline|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27269|NCT02094885|B1|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27270|NCT02094885|P2|Participant Flow|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27271|NCT02094885|P1|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27272|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27273|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27274|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27275|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27276|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27277|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27278|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27279|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27280|NCT02094885|E2|Reported Event|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
27281|NCT02094885|E1|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
27282|NCT02094677|B3|Baseline|Total|Total of all reporting groups
27283|NCT02094677|B2|Baseline|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27284|NCT02094677|B1|Baseline|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27285|NCT02094677|P2|Participant Flow|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27286|NCT02094677|P1|Participant Flow|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27287|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27288|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27289|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27290|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27291|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27292|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27293|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27393|NCT02093923|B1|Baseline|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27394|NCT02093923|P5|Participant Flow|Placebo|Placebo administered twice, two weeks apart
27294|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27295|NCT02094677|O2|Outcome|Control - Nelilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27296|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27297|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27298|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27299|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27300|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27301|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27302|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27303|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27304|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27305|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27306|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27307|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27308|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27309|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
27310|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
27311|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27312|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27313|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27314|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27315|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27316|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27317|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27318|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27319|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27320|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27321|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27322|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27323|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27324|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27325|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27326|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27327|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27328|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27329|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27330|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27331|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27332|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27333|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27334|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27335|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27336|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27337|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27338|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27339|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27340|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27341|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27342|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27343|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
27344|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
27395|NCT02093923|P4|Participant Flow|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27396|NCT02093923|P3|Participant Flow|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27345|NCT02094677|E2|Reported Event|Filcon II 3 and Nelfilcon A|"Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
27346|NCT02094677|E1|Reported Event|Filcon II 3 and Etafilcon A|"Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
27347|NCT02094443|B3|Baseline|Total|Total of all reporting groups
27348|NCT02094443|B2|Baseline|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27349|NCT02094443|B1|Baseline|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27350|NCT02094443|P2|Participant Flow|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27351|NCT02094443|P1|Participant Flow|Alisporivir 300 mg BID|Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
27352|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27353|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27354|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27355|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27356|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27357|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27358|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27359|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27360|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27361|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27362|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27363|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27364|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27365|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27366|NCT02094443|E2|Reported Event|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
27367|NCT02094443|E1|Reported Event|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
27368|NCT02094326|B1|Baseline|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27369|NCT02094326|P1|Participant Flow|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27370|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27371|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27372|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27373|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27374|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the classification of rheumatoid arthritis (ACR) 2010 criteria from 2008 to 2012, and initiated on at least one disease-modifying antirheumatic drug (DMARD) during this period.
27375|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27376|NCT02094326|E1|Reported Event|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
27377|NCT02094300|B1|Baseline|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
27378|NCT02094300|P1|Participant Flow|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
27379|NCT02094300|O1|Outcome|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
27380|NCT02094300|E1|Reported Event|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
27381|NCT02094261|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
27382|NCT02094261|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
27383|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
27384|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
27385|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
27386|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
27387|NCT02094261|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
27388|NCT02093923|B6|Baseline|Total|Total of all reporting groups
27389|NCT02093923|B5|Baseline|Placebo|Placebo administered twice, two weeks apart
27390|NCT02093923|B4|Baseline|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27391|NCT02093923|B3|Baseline|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27400|NCT02093923|O3|Outcome|DX-2930, Combined Dose Level 3 and Dose Level 4|This arm includes the total subjects analysed for Dose level 3 and Dose level 4 combined.
27401|NCT02093923|O2|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27402|NCT02093923|O1|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27403|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27404|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27405|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27406|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27407|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27408|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27409|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27410|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27411|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27412|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27413|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27414|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27415|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27416|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27417|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27418|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27419|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27420|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27421|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27422|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27423|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27424|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27425|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27426|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27427|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
27428|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27429|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27430|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27431|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27432|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
27433|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27434|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27435|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27436|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27437|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
27438|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27439|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27440|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27441|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27442|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
27443|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27444|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27445|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27446|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27447|NCT02093923|E5|Reported Event|Placebo|Placebo administered twice, two weeks apart
27448|NCT02093923|E4|Reported Event|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
27449|NCT02093923|E3|Reported Event|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
27450|NCT02093923|E2|Reported Event|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
27451|NCT02093923|E1|Reported Event|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
27452|NCT02093897|B1|Baseline|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
27491|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27638|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27639|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
27453|NCT02093897|P1|Participant Flow|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
27454|NCT02093897|O1|Outcome|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
27455|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
27456|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
27457|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
27458|NCT02093897|O1|Outcome|Pharmacokinetic Population|The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
27459|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27460|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27461|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27462|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27463|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27464|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27465|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27492|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27640|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
27641|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27466|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
27467|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
27468|NCT02093897|O2|Outcome|Prophylaxis|Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.
27469|NCT02093897|O1|Outcome|On-demand|Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.
27470|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
27471|NCT02093897|E1|Reported Event|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
27472|NCT02093819|B9|Baseline|Total|Total of all reporting groups
27473|NCT02093819|B8|Baseline|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27474|NCT02093819|B7|Baseline|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27475|NCT02093819|B6|Baseline|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27476|NCT02093819|B5|Baseline|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27477|NCT02093819|B4|Baseline|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27478|NCT02093819|B3|Baseline|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27479|NCT02093819|B2|Baseline|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27480|NCT02093819|B1|Baseline|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27481|NCT02093819|P8|Participant Flow|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27482|NCT02093819|P7|Participant Flow|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27483|NCT02093819|P6|Participant Flow|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27484|NCT02093819|P5|Participant Flow|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27485|NCT02093819|P4|Participant Flow|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27486|NCT02093819|P3|Participant Flow|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27487|NCT02093819|P2|Participant Flow|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27488|NCT02093819|P1|Participant Flow|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27489|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27490|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27628|NCT02092961|B1|Baseline|FOSTA 100 MG PO BID|Dosing Group A
27493|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27494|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27495|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27496|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27497|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27498|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27499|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27500|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27501|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27502|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27503|NCT02093819|O8|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27504|NCT02093819|O7|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27505|NCT02093819|O6|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27506|NCT02093819|O5|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27507|NCT02093819|O4|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27508|NCT02093819|O3|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27509|NCT02093819|O2|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27510|NCT02093819|O1|Outcome|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h
27511|NCT02093819|E10|Reported Event|Total Treatment|All patients affected by AEs during entire treatment period.
27512|NCT02093819|E9|Reported Event|Total BI 416970 Treatment|All patients affected by AEs during administration of BI 416970 medication .
27513|NCT02093819|E8|Reported Event|BI 416970 600 mg|The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27514|NCT02093819|E7|Reported Event|BI 416970 400 mg|The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27515|NCT02093819|E6|Reported Event|BI 416970 200 mg|The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27516|NCT02093819|E5|Reported Event|BI 416970 100 mg|The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27517|NCT02093819|E4|Reported Event|BI 416970 50 mg|The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27518|NCT02093819|E3|Reported Event|BI 416970 25 mg|The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27519|NCT02093819|E2|Reported Event|BI 416970 10 mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27520|NCT02093819|E1|Reported Event|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
27521|NCT02093702|B3|Baseline|Total|Total of all reporting groups
27522|NCT02093702|B2|Baseline|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
27523|NCT02093702|B1|Baseline|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
27524|NCT02093702|P2|Participant Flow|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
27525|NCT02093702|P1|Participant Flow|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
27526|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27527|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27528|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27529|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27530|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27531|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27532|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27533|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27534|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27535|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27536|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27537|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27538|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27539|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27540|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27541|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27542|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27543|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27544|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27545|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27546|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27547|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27548|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27549|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27550|NCT02093702|E2|Reported Event|Standard PA Education for People With T2DM (From a CDE)|Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
27551|NCT02093702|E1|Reported Event|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
27552|NCT02093390|B3|Baseline|Total|Total of all reporting groups
27553|NCT02093390|B2|Baseline|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27554|NCT02093390|B1|Baseline|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27629|NCT02092961|P3|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27630|NCT02092961|P2|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
27555|NCT02093390|P2|Participant Flow|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27556|NCT02093390|P1|Participant Flow|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27557|NCT02093390|O1|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27558|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27559|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27560|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27561|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27562|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27563|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27564|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27565|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27566|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27567|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27568|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27569|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27570|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27571|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27572|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27573|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27574|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27575|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27631|NCT02092961|P1|Participant Flow|FOSTA 100 MG PO BID|Dosing Group A
27632|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27576|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27577|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27578|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27579|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27580|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27581|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27582|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27583|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27584|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27585|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27586|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27587|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27588|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27589|NCT02093390|E2|Reported Event|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
27590|NCT02093390|E1|Reported Event|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
27591|NCT02093351|B4|Baseline|Total|Total of all reporting groups
27592|NCT02093351|B3|Baseline|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27593|NCT02093351|B2|Baseline|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27594|NCT02093351|B1|Baseline|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27595|NCT02093351|P3|Participant Flow|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27596|NCT02093351|P2|Participant Flow|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27597|NCT02093351|P1|Participant Flow|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27633|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
27634|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
27598|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
27599|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27600|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
27601|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
27602|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
27603|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27604|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
27605|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
27606|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
27607|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27608|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
27609|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
27610|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
27611|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27612|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
27613|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
27614|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
27615|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27616|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
27617|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
27618|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
27619|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
27620|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
27621|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
27622|NCT02093351|E3|Reported Event|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27623|NCT02093351|E2|Reported Event|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27624|NCT02093351|E1|Reported Event|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
27625|NCT02092961|B4|Baseline|Total|Total of all reporting groups
27626|NCT02092961|B3|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27627|NCT02092961|B2|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
27644|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
27645|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
27646|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
27647|NCT02092961|E4|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
27648|NCT02092961|E3|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
27649|NCT02092961|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
27650|NCT02092961|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
27651|NCT02092857|B4|Baseline|Total|Total of all reporting groups
27652|NCT02092857|B3|Baseline|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
27653|NCT02092857|B2|Baseline|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
27654|NCT02092857|B1|Baseline|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
27655|NCT02092857|P3|Participant Flow|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
27656|NCT02092857|P2|Participant Flow|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
27657|NCT02092857|P1|Participant Flow|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
27658|NCT02092857|O3|Outcome|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
27659|NCT02092857|O2|Outcome|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
27660|NCT02092857|O1|Outcome|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
27661|NCT02092857|E3|Reported Event|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
27662|NCT02092857|E2|Reported Event|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
27663|NCT02092857|E1|Reported Event|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
27664|NCT02092662|B3|Baseline|Total|Total of all reporting groups
27665|NCT02092662|B2|Baseline|Control|healthy volunteers
27666|NCT02092662|B1|Baseline|Study|patients after a stroke
27667|NCT02092662|P2|Participant Flow|Control|Healthy voluntiers
27668|NCT02092662|P1|Participant Flow|Patients After a Stroke|Patients who admitted to the hospital for rehabilitation after a stroke
27669|NCT02092662|O2|Outcome|Healthy Controls|"healthy age-matched voluntiers~Healthy controls: no treatment~Deltoid onset time 0.79 sec"
27670|NCT02092662|O1|Outcome|Stroke|"Stroke patients at the subacute phase~stroke: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context."
27671|NCT02092662|O2|Outcome|Control|Healthy age-matched
27672|NCT02092662|O1|Outcome|Study Group (T1)|Patients after a stroke
27673|NCT02092662|E1|Reported Event|Study|Patients after a stroke
27674|NCT02092649|B3|Baseline|Total|Total of all reporting groups
27675|NCT02092649|B2|Baseline|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27676|NCT02092649|B1|Baseline|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27677|NCT02092649|P2|Participant Flow|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27678|NCT02092649|P1|Participant Flow|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27679|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27680|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27681|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27682|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27683|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27684|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27685|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27686|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27687|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27688|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27689|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27690|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
61191|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
27691|NCT02092649|E2|Reported Event|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
27692|NCT02092649|E1|Reported Event|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
27693|NCT02092610|B3|Baseline|Total|Total of all reporting groups
27694|NCT02092610|B2|Baseline|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27695|NCT02092610|B1|Baseline|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27696|NCT02092610|P2|Participant Flow|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27697|NCT02092610|P1|Participant Flow|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27698|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27699|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27700|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27701|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27702|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27703|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27704|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27705|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27706|NCT02092610|E2|Reported Event|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
27707|NCT02092610|E1|Reported Event|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
27708|NCT02092441|B3|Baseline|Total|Total of all reporting groups
27709|NCT02092441|B2|Baseline|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27710|NCT02092441|B1|Baseline|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27711|NCT02092441|P2|Participant Flow|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27712|NCT02092441|P1|Participant Flow|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27713|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27714|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27715|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27716|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27717|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27718|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27719|NCT02092441|E2|Reported Event|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
27720|NCT02092441|E1|Reported Event|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
27721|NCT02092415|B1|Baseline|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
27722|NCT02092415|P1|Participant Flow|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
27723|NCT02092415|O2|Outcome|Normal Subjects - Tourniquet Flow|Perfusion measured at time of tourniquet placement
27724|NCT02092415|O1|Outcome|Normal Subjects Baseline Flow|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
27725|NCT02092415|E1|Reported Event|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
27726|NCT02092350|B3|Baseline|Total|Total of all reporting groups
27727|NCT02092350|B2|Baseline|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27728|NCT02092350|B1|Baseline|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27729|NCT02092350|P2|Participant Flow|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27730|NCT02092350|P1|Participant Flow|Immediate Treatment + Intensive PK|Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
27731|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27732|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27733|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27734|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27735|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27736|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27737|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27738|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27739|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27740|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27741|NCT02092350|E3|Reported Event|Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks|Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
27742|NCT02092350|E2|Reported Event|Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
27743|NCT02092350|E1|Reported Event|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
27744|NCT02092311|B3|Baseline|Total|Total of all reporting groups
27745|NCT02092311|B2|Baseline|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27746|NCT02092311|B1|Baseline|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
27747|NCT02092311|P2|Participant Flow|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27748|NCT02092311|P1|Participant Flow|Combined Microscopic Varicocelectomy|Combined Mini-Incision Microscopic Varicocelectomy
27749|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27750|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
27751|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27752|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
27753|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27754|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
27755|NCT02092311|E2|Reported Event|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
27756|NCT02092311|E1|Reported Event|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
27757|NCT02092168|B3|Baseline|Total|Total of all reporting groups
27758|NCT02092168|B2|Baseline|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
27759|NCT02092168|B1|Baseline|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
27760|NCT02092168|P2|Participant Flow|BIA 9-1067 30 mg (QD) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Young Subjects"
27761|NCT02092168|P1|Participant Flow|BIA 9-1067 30 mg (QD) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Elderly Subjects"
27762|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
27763|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
27764|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
27765|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
27766|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
27767|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
27768|NCT02092168|E2|Reported Event|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
27769|NCT02092168|E1|Reported Event|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
27770|NCT02091856|B4|Baseline|Total|Total of all reporting groups
27771|NCT02091856|B3|Baseline|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27772|NCT02091856|B2|Baseline|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27815|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27972|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
61192|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
27773|NCT02091856|B1|Baseline|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27774|NCT02091856|P3|Participant Flow|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27775|NCT02091856|P2|Participant Flow|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27776|NCT02091856|P1|Participant Flow|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27777|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27778|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27779|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27780|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27781|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27782|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27783|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27784|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27785|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27786|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27816|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27817|NCT02091726|E1|Reported Event|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27787|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27788|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27789|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27790|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27791|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27792|NCT02091856|E3|Reported Event|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
27793|NCT02091856|E2|Reported Event|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
27794|NCT02091856|E1|Reported Event|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
27795|NCT02091778|B1|Baseline|Fast Gelling Dressing|Fast gelling dressing
27796|NCT02091778|P1|Participant Flow|Fast Gelling Dressing|Fast gelling dressing
27797|NCT02091778|O1|Outcome|Fast Gelling Dressing|Fast gelling dressing
27798|NCT02091778|E1|Reported Event|Fast Gelling Dressing|Fast gelling dressing
27799|NCT02091752|B1|Baseline|Ruxolitinib|All participants received ruxolitinib.
27800|NCT02091752|P1|Participant Flow|Ruxolitinib|All participants received ruxolitinib.
27801|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27802|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27803|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27804|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27805|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27806|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27807|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27808|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
27809|NCT02091752|E1|Reported Event|Ruxolitinib|All participants received ruxolitinib.
27810|NCT02091726|B1|Baseline|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27811|NCT02091726|P1|Participant Flow|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27812|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27813|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27814|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
27819|NCT02091466|B2|Baseline|Control|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
27820|NCT02091466|B1|Baseline|Pre-warming|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
27821|NCT02091466|P2|Participant Flow|Control|patients were under passive heating in control groups before anesthesia
27822|NCT02091466|P1|Participant Flow|Pre-warming|"patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
27823|NCT02091466|O2|Outcome|Control|Patients remained without the use of a thermal gown,
27824|NCT02091466|O1|Outcome|Pre-warming|Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
27825|NCT02091466|E2|Reported Event|Control|Patients were under passive heating in control groups before anesthesia
27826|NCT02091466|E1|Reported Event|Pre-warming|"Patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
27827|NCT02091414|B1|Baseline|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27828|NCT02091414|P1|Participant Flow|Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)|Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27829|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27830|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27831|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27832|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27833|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27834|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27835|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27836|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27837|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27838|NCT02091414|E1|Reported Event|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
27839|NCT02090855|B1|Baseline|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
27840|NCT02090855|P1|Participant Flow|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
27841|NCT02090855|O1|Outcome|Percentage of Specificity for Normal Reads|This is the percentage of Specificity with the normal image interpretations.
27842|NCT02090855|O1|Outcome|Percentage of Sensitivity With Abnormal Reads|This is the percent of sensitivity with the Abnormal image interpretations.
27843|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 30 image interpretations when combining normal and abnormal readings.The Standard of Truth (SoT) is based on no/sparse neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria based on specimens stained with the Bielschowsky silver stain.
27844|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
27845|NCT02090855|E1|Reported Event|Flutemetamol (18F)|This study was to assess the PET images only. There was no drug administered in this study.
27846|NCT02090777|B1|Baseline|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
27847|NCT02090777|P1|Participant Flow|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
27848|NCT02090777|O1|Outcome|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
27849|NCT02090777|E1|Reported Event|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
27850|NCT02090764|B3|Baseline|Total|Total of all reporting groups
27851|NCT02090764|B2|Baseline|Placebo|"Placebo cream~Placebo"
27852|NCT02090764|B1|Baseline|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
27853|NCT02090764|P2|Participant Flow|Placebo|"Placebo cream~Placebo"
27854|NCT02090764|P1|Participant Flow|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
27855|NCT02090764|O2|Outcome|Placebo|"Placebo cream~Placebo"
27856|NCT02090764|O1|Outcome|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
27857|NCT02090764|E2|Reported Event|Placebo|"Placebo cream~Placebo"
27858|NCT02090764|E1|Reported Event|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
27859|NCT02090413|B4|Baseline|Total|Total of all reporting groups
27860|NCT02090413|B3|Baseline|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27861|NCT02090413|B2|Baseline|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27862|NCT02090413|B1|Baseline|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27863|NCT02090413|P3|Participant Flow|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27864|NCT02090413|P2|Participant Flow|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27865|NCT02090413|P1|Participant Flow|DMF + ASA-Placebo BID|Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27866|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27867|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27868|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27869|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27870|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27871|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27872|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27873|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27874|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27875|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27876|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27877|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27878|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27879|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27880|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27881|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27882|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27883|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27884|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27885|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27886|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27887|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27888|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27889|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27890|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27891|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27892|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27893|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27894|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27895|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27896|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27897|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27898|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27899|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27925|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27900|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27901|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27902|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27903|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27904|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27905|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27906|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27907|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27908|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27909|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27910|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27911|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27912|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27913|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27914|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27915|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27916|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27917|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27918|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27919|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27920|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27921|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27922|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27923|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27924|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27970|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27971|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27926|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27927|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27928|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27929|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27930|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27931|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27932|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27933|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27934|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27935|NCT02090413|E3|Reported Event|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27936|NCT02090413|E2|Reported Event|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27937|NCT02090413|E1|Reported Event|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
27938|NCT02090088|B1|Baseline|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27939|NCT02090088|P1|Participant Flow|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27940|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27941|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27942|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27943|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27944|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27945|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27946|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27947|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27948|NCT02090088|E2|Reported Event|Infants|Infants who were born to enrolled participants during the study.
27949|NCT02090088|E1|Reported Event|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
27950|NCT02089347|B3|Baseline|Total|Total of all reporting groups
27951|NCT02089347|B2|Baseline|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27952|NCT02089347|B1|Baseline|SP306 Group|Participants received SP306 vaccine intramuscularly
27953|NCT02089347|P2|Participant Flow|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27954|NCT02089347|P1|Participant Flow|SP306 Group|Participants received SP306 vaccine intramuscularly
27955|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27956|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27957|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27958|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27959|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27960|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27961|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27962|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27963|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27964|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27965|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27966|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27967|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27968|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
27969|NCT02089347|O2|Outcome|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27973|NCT02089347|E2|Reported Event|DT Biken Group|Participants received DT BIK® vaccine subcutaneously
27974|NCT02089347|E1|Reported Event|SP306 Group|Participants received SP306 vaccine intramuscularly
27975|NCT02089191|B1|Baseline|Overall|Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
27976|NCT02089191|P2|Participant Flow|MyDay/DACP|Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
27977|NCT02089191|P1|Participant Flow|DACP/MyDay|Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2
27978|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
27979|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
27980|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
27981|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
27982|NCT02089191|E2|Reported Event|MyDay|Stenfilcon A contact lenses
27983|NCT02089191|E1|Reported Event|DACP|Nelfilcon A contact lenses
27984|NCT02089113|B3|Baseline|Total|Total of all reporting groups
27985|NCT02089113|B2|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
27986|NCT02089113|B1|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone"
27987|NCT02089113|P2|Participant Flow|Placebo Vehicle Punctum Plug|No drug treatment
27988|NCT02089113|P1|Participant Flow|Dexamethasone Punctum Plug|Drug treatment
27989|NCT02089113|O2|Outcome|Placebo Vehicle Punctum Plug|No drug treatment
27990|NCT02089113|O1|Outcome|Dexamethasone Punctum Plug|Drug treatment
27991|NCT02089113|E2|Reported Event|Placebo Vehicle Punctum Plug|No drug treatment
27992|NCT02089113|E1|Reported Event|Dexamethasone Punctum Plug|Drug treatment
27993|NCT02088957|B1|Baseline|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27994|NCT02088957|P2|Participant Flow|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27995|NCT02088957|P1|Participant Flow|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27996|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27997|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27998|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
27999|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28013|NCT02087943|B1|Baseline|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
28047|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
28000|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28001|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28002|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28003|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28004|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28005|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28006|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28007|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28008|NCT02088957|E2|Reported Event|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28009|NCT02088957|E1|Reported Event|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
28010|NCT02087943|B4|Baseline|Total|Total of all reporting groups
28011|NCT02087943|B3|Baseline|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28012|NCT02087943|B2|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
61193|NCT01809106|E4|Reported Event|Fentanyl|Fentanyl: 25 microg/h
28014|NCT02087943|P5|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
28015|NCT02087943|P4|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
28016|NCT02087943|P3|Participant Flow|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
28017|NCT02087943|P2|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
28018|NCT02087943|P1|Participant Flow|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28019|NCT02087943|O2|Outcome|Apremilast 40 mg|Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
28020|NCT02087943|O1|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
28021|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28022|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28023|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28024|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28025|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28026|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28027|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28028|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28029|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28030|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28031|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28032|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28033|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28034|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28035|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28036|NCT02087943|E5|Reported Event|Apremilast 40 mg (Apremilast Exposure Period) 0-24|Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
28037|NCT02087943|E4|Reported Event|Apremilast 30 mg (Apremilast Exposure Period) 0-24|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
28038|NCT02087943|E3|Reported Event|Apremilast 40 mg (Weeks 0-12)|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28039|NCT02087943|E2|Reported Event|Apremilast 30 mg (Weeks 0-12)|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
28040|NCT02087943|E1|Reported Event|Placebo (Weeks 0-12)|Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
28041|NCT02087774|B3|Baseline|Total|Total of all reporting groups
28042|NCT02087774|B2|Baseline|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
28043|NCT02087774|B1|Baseline|Control School|Control School received no intervention.
28044|NCT02087774|P2|Participant Flow|Intervention Group|"Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).~Physical Activity and Incentives"
28045|NCT02087774|P1|Participant Flow|Control School|Control School received no intervention.
28046|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
28048|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
28049|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
28050|NCT02087774|E2|Reported Event|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
28051|NCT02087774|E1|Reported Event|Control School|Control School received no intervention.
28052|NCT02087748|B1|Baseline|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
28053|NCT02087748|P1|Participant Flow|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
28054|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
28055|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
28056|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
28057|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
28058|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
28059|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
28060|NCT02087748|E2|Reported Event|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
28061|NCT02087748|E1|Reported Event|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
28062|NCT02087670|B3|Baseline|Total|Total of all reporting groups
28063|NCT02087670|B2|Baseline|Community Based Exercise|educational program and not supervises exercise program
28064|NCT02087670|B1|Baseline|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
28065|NCT02087670|P2|Participant Flow|Community Based Exercise|educational program and not supervises exercise program
28066|NCT02087670|P1|Participant Flow|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
28067|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
28068|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
28069|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
28070|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
28071|NCT02087670|E2|Reported Event|Community Based Exercise|educational program and not supervises exercise program
28072|NCT02087670|E1|Reported Event|Controlled, Supervised Exercise Protocol|controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program
28073|NCT02087176|B1|Baseline|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
28074|NCT02087176|P1|Participant Flow|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
28075|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
28076|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
28077|NCT02087176|E1|Reported Event|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
28078|NCT02087059|B1|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28079|NCT02087059|P1|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28080|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28081|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28082|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
29598|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
28083|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28084|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28085|NCT02087059|E1|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
28086|NCT02086708|B1|Baseline|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
28087|NCT02086708|P1|Participant Flow|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
28088|NCT02086708|O5|Outcome|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
28089|NCT02086708|O4|Outcome|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
28090|NCT02086708|O3|Outcome|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
28091|NCT02086708|O2|Outcome|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
28092|NCT02086708|O1|Outcome|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
28093|NCT02086708|E5|Reported Event|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
28094|NCT02086708|E4|Reported Event|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
28095|NCT02086708|E3|Reported Event|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
28096|NCT02086708|E2|Reported Event|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
28097|NCT02086708|E1|Reported Event|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
28098|NCT02086591|B1|Baseline|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28099|NCT02086591|P1|Participant Flow|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28100|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28101|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28102|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28103|NCT02086591|E1|Reported Event|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
28104|NCT02085720|B1|Baseline|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
28105|NCT02085720|P1|Participant Flow|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
28106|NCT02085720|O1|Outcome|Sleep Heatlh Questionnaire Result|We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres.
28107|NCT02085720|O1|Outcome|AHI Result|Subjects who had completed the questionnaires and consented for sleep study were invited to undergo a portable at-home sleep study. In the afternoon, subjects attended the pulmonary function laboratory to be fitted with the EmblettaTM portable diagnostic system (PDS, Medcare, Iceland). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Respiratory events were scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea was defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data were included in the analysis if the total recorded evaluation time of 4 hrs or longer was obtained during the EmblettaTM PDS study.
28108|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
28135|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28229|NCT02084082|E4|Reported Event|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28109|NCT02085720|O1|Outcome|Chinese Elderly OSAS|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
28110|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
28111|NCT02085720|E1|Reported Event|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
28112|NCT02085161|B5|Baseline|Total|Total of all reporting groups
28113|NCT02085161|B4|Baseline|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28114|NCT02085161|B3|Baseline|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28115|NCT02085161|B2|Baseline|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28116|NCT02085161|B1|Baseline|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28117|NCT02085161|P4|Participant Flow|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28118|NCT02085161|P3|Participant Flow|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28119|NCT02085161|P2|Participant Flow|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28120|NCT02085161|P1|Participant Flow|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28121|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28122|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28123|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28124|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28125|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28126|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28127|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28128|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28129|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28130|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28131|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28132|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28133|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28134|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28136|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28137|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28138|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28139|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28140|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28141|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28142|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28143|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28144|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28145|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28146|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28147|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28148|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28149|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28150|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28151|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28152|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28153|NCT02085161|E5|Reported Event|Total|Total
28154|NCT02085161|E4|Reported Event|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
28155|NCT02085161|E3|Reported Event|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28156|NCT02085161|E2|Reported Event|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28157|NCT02085161|E1|Reported Event|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
28158|NCT02084797|B1|Baseline|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28159|NCT02084797|P1|Participant Flow|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28227|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28323|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28160|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28161|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28162|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28163|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28164|NCT02084797|E1|Reported Event|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
28165|NCT02084706|B3|Baseline|Total|Total of all reporting groups
28166|NCT02084706|B2|Baseline|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
28167|NCT02084706|B1|Baseline|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
28168|NCT02084706|P2|Participant Flow|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
28169|NCT02084706|P1|Participant Flow|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
28170|NCT02084706|O2|Outcome|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
28171|NCT02084706|O1|Outcome|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
28228|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28172|NCT02084706|E2|Reported Event|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
28173|NCT02084706|E1|Reported Event|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
28174|NCT02084628|B1|Baseline|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28175|NCT02084628|P1|Participant Flow|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participant to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28176|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28177|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28178|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28179|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28180|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28181|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28182|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28183|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28184|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28185|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28186|NCT02084628|E1|Reported Event|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
28187|NCT02084238|B1|Baseline|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease."
28188|NCT02084238|P1|Participant Flow|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease."
28189|NCT02084238|O1|Outcome|SLEDAI Score|SLEDAI score at week 0 and week 10.
28190|NCT02084238|O3|Outcome|Laboratory Variables 3|Serum anti-dsDNA antibodies in patients with SLE
28191|NCT02084238|O2|Outcome|Laboratory Variables 2|Serum complement 4 in SLE patients
28192|NCT02084238|O1|Outcome|Laboratory Variables 1|Serum complement 3 in SLE patients
28193|NCT02084238|O3|Outcome|Immunological Responses 3|Th17 in CD4+T cells in 23 patients with SLE
28194|NCT02084238|O2|Outcome|Immunological Responses 2|Tfh cells in CD4+ T cells in 23 patients with SLE
28195|NCT02084238|O1|Outcome|Immunological Responses 1|Treg in total CD4+T cells in 23 patients with SLE
28196|NCT02084238|O1|Outcome|SRI Results|All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).
28197|NCT02084238|E1|Reported Event|IL-2 Therapy in SLE|All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
28198|NCT02084082|B3|Baseline|Total|Total of all reporting groups
28199|NCT02084082|B2|Baseline|FDC 1000 Fed or L+M 1000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28200|NCT02084082|B1|Baseline|FDC 1000 Fast or L+M 1000 Fast|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28201|NCT02084082|P4|Participant Flow|L+M1000 Fed/ FDC1000 Fed|"Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28202|NCT02084082|P3|Participant Flow|FDC1000 Fed/L+M1000 Fed|"Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28203|NCT02084082|P2|Participant Flow|L+M1000 Fast/ FDC1000 Fast|"Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28204|NCT02084082|P1|Participant Flow|FDC 1000 Fast/ L+M 1000 Fast|"Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
28205|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28206|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28207|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28208|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28209|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28210|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28211|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28212|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28213|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28214|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28215|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28216|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28217|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28218|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28219|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28220|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28221|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28222|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28223|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28224|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28225|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
28226|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28324|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28230|NCT02084082|E3|Reported Event|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
28231|NCT02084082|E2|Reported Event|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
28232|NCT02084082|E1|Reported Event|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
28233|NCT02084069|B3|Baseline|Total|Total of all reporting groups
28234|NCT02084069|B2|Baseline|Control|Placebo
28235|NCT02084069|B1|Baseline|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
28236|NCT02084069|P2|Participant Flow|Control|Placebo
28237|NCT02084069|P1|Participant Flow|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
28238|NCT02084069|O2|Outcome|Control|Placebo
28239|NCT02084069|O1|Outcome|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
28240|NCT02084069|E2|Reported Event|Control|Placebo
28241|NCT02084069|E1|Reported Event|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
28242|NCT02084056|B3|Baseline|Total|Total of all reporting groups
28243|NCT02084056|B2|Baseline|FDC 2000 Fed or L+M 2000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.~L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28244|NCT02084056|B1|Baseline|FDC 2000 Fasted or L+M 2000 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28245|NCT02084056|P4|Participant Flow|L+M 2000 Fed / FDC 2000 Fed|"Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28246|NCT02084056|P3|Participant Flow|FDC 2000 Fed / L+M 2000 Fed|"Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28247|NCT02084056|P2|Participant Flow|L+M 2000 Fasted / FDC 2000 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28248|NCT02084056|P1|Participant Flow|FDC 2000 Fasted / L+M 2000 Fasted|"Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
28249|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28250|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28251|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28252|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28253|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28254|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28255|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28256|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28257|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28258|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28259|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28260|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28261|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28262|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28263|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28264|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28265|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28266|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28267|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28268|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28269|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28270|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28271|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28272|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28273|NCT02084056|E4|Reported Event|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
28274|NCT02084056|E3|Reported Event|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
28275|NCT02084056|E2|Reported Event|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
28276|NCT02084056|E1|Reported Event|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
28277|NCT02083965|B3|Baseline|Total|Total of all reporting groups
28278|NCT02083965|B2|Baseline|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28279|NCT02083965|B1|Baseline|rFVIIIFc 1000 / 3000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28280|NCT02083965|P2|Participant Flow|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28325|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28326|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28327|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28328|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
29599|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
28281|NCT02083965|P1|Participant Flow|rFVIIIFc 1000 / 3000|"Following a minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of pharmacokinetic (PK) assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28282|NCT02083965|O1|Outcome|rFVIIIFc|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28283|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28284|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28285|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28286|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28287|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28288|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28289|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28290|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28291|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28292|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28293|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28294|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28295|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28296|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28297|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28298|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28299|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28300|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28301|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28302|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28303|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28304|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28305|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28306|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28307|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28308|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28309|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28310|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28311|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28312|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28313|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28314|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28315|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28316|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28317|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28318|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28319|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|rFVIIIFc single injection 50 IU/kg at a strength of 3000 IU/vial
28320|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28321|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28322|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
63424|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
28329|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28330|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28331|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28332|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28333|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
28334|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
28335|NCT02083965|E1|Reported Event|Total Active|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
28336|NCT02083679|B5|Baseline|Total|Total of all reporting groups
28337|NCT02083679|B4|Baseline|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28338|NCT02083679|B3|Baseline|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28339|NCT02083679|B2|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28340|NCT02083679|B1|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28341|NCT02083679|P4|Participant Flow|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28342|NCT02083679|P3|Participant Flow|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28343|NCT02083679|P2|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28344|NCT02083679|P1|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28345|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28364|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28365|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28346|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28347|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28348|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28349|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28350|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28351|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28352|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28353|NCT02083679|E4|Reported Event|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28354|NCT02083679|E3|Reported Event|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28355|NCT02083679|E2|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28356|NCT02083679|E1|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
28357|NCT02083406|B4|Baseline|Total|Total of all reporting groups
28358|NCT02083406|B3|Baseline|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28359|NCT02083406|B2|Baseline|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28360|NCT02083406|B1|Baseline|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28361|NCT02083406|P3|Participant Flow|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28362|NCT02083406|P2|Participant Flow|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28363|NCT02083406|P1|Participant Flow|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28366|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28367|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28368|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28369|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28370|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28371|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28372|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28373|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28374|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28375|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28376|NCT02083406|E3|Reported Event|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
28377|NCT02083406|E2|Reported Event|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
28378|NCT02083406|E1|Reported Event|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
28379|NCT02083380|B4|Baseline|Total|Total of all reporting groups
28380|NCT02083380|B3|Baseline|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
28381|NCT02083380|B2|Baseline|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
28382|NCT02083380|B1|Baseline|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine 640mg
28383|NCT02083380|P3|Participant Flow|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28384|NCT02083380|P2|Participant Flow|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28385|NCT02083380|P1|Participant Flow|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28386|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
28387|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
28388|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
28389|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|"Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined~Artefenomel 800mg: PQP 640mg, 960mg & 1440mg"
28390|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28391|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28392|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28393|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28394|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28395|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28396|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28397|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28398|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28399|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28400|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28401|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28402|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28403|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28404|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28405|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28406|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28407|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28408|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28409|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28410|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28411|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28412|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28413|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
63425|NCT01789476|O1|Outcome|Placebo|Matched placebo
28414|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28415|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28416|NCT02083380|O1|Outcome|A) Arttefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28417|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28418|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28419|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28420|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28421|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28422|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28423|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28424|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28425|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28426|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28427|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28428|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28429|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28430|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28431|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28432|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28433|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28434|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28435|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28436|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28437|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28438|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28439|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28440|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28441|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28442|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28443|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28444|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|C) Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28445|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28446|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28447|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28448|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28449|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28450|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28451|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28452|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28453|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28454|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28455|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28456|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28457|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28458|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28459|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28460|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28461|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28462|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
63426|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
28463|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28464|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28465|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28466|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28467|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28468|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28469|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28470|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
28471|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
28472|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
28473|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: piperaquine 640mg: Active, loose combination
28474|NCT02083380|E3|Reported Event|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
28475|NCT02083380|E2|Reported Event|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
28476|NCT02083380|E1|Reported Event|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg
28477|NCT02083263|B3|Baseline|Total|Total of all reporting groups
28478|NCT02083263|B2|Baseline|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
28479|NCT02083263|B1|Baseline|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
28480|NCT02083263|P2|Participant Flow|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
28481|NCT02083263|P1|Participant Flow|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
28482|NCT02083263|O2|Outcome|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
28483|NCT02083263|O1|Outcome|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
28484|NCT02083263|E2|Reported Event|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
28485|NCT02083263|E1|Reported Event|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
28486|NCT02083107|B4|Baseline|Total|Total of all reporting groups
28487|NCT02083107|B3|Baseline|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28488|NCT02083107|B2|Baseline|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28489|NCT02083107|B1|Baseline|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28490|NCT02083107|P3|Participant Flow|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28491|NCT02083107|P2|Participant Flow|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28492|NCT02083107|P1|Participant Flow|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28493|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28494|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28495|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28496|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28497|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28498|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28499|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28500|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28501|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28502|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28503|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28504|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28544|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
29600|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
28505|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28506|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28507|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28508|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28509|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28510|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28511|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28512|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28513|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28514|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28515|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28516|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28517|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28518|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28519|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28520|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28521|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28522|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28523|NCT02083107|E3|Reported Event|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28524|NCT02083107|E2|Reported Event|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
28525|NCT02083107|E1|Reported Event|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
28526|NCT02082912|B3|Baseline|Total|Total of all reporting groups
28527|NCT02082912|B2|Baseline|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
28528|NCT02082912|B1|Baseline|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
28529|NCT02082912|P2|Participant Flow|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
28530|NCT02082912|P1|Participant Flow|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
28531|NCT02082912|O2|Outcome|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
28532|NCT02082912|O1|Outcome|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
28533|NCT02082912|E2|Reported Event|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
28534|NCT02082912|E1|Reported Event|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
28535|NCT02082769|B4|Baseline|Total|Total of all reporting groups
28536|NCT02082769|B3|Baseline|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28537|NCT02082769|B2|Baseline|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
28538|NCT02082769|B1|Baseline|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
28539|NCT02082769|P3|Participant Flow|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28540|NCT02082769|P2|Participant Flow|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
28541|NCT02082769|P1|Participant Flow|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
28542|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28543|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
29601|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
28545|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28546|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
28547|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
28548|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28549|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
28550|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
28551|NCT02082769|E3|Reported Event|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
28552|NCT02082769|E2|Reported Event|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
28553|NCT02082769|E1|Reported Event|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
28554|NCT02082288|B1|Baseline|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
28555|NCT02082288|P1|Participant Flow|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
28556|NCT02082288|O1|Outcome|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
28557|NCT02082288|E1|Reported Event|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
28558|NCT02082262|B1|Baseline|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
28559|NCT02082262|P1|Participant Flow|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
28560|NCT02082262|O1|Outcome|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
28561|NCT02082262|E1|Reported Event|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
28562|NCT02082158|B7|Baseline|Total|Total of all reporting groups
28563|NCT02082158|B6|Baseline|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28564|NCT02082158|B5|Baseline|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28565|NCT02082158|B4|Baseline|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28566|NCT02082158|B3|Baseline|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28567|NCT02082158|B2|Baseline|Non-Local Respirator Model|"Subjects randomized to a current respirator design will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28568|NCT02082158|B1|Baseline|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28569|NCT02082158|P6|Participant Flow|Prototype 4 Respirator Design|"Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities.~Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28570|NCT02082158|P5|Participant Flow|Prototype 3 Respirator Design|"Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities.~Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28571|NCT02082158|P4|Participant Flow|Prototype 2 Respirator Design|"Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities.~Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28572|NCT02082158|P3|Participant Flow|Prototype 1 Respirator Design|"Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities.~Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
29602|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
28573|NCT02082158|P2|Participant Flow|Non-Local Respirator Model|"Subjects randomized to the non-local respirator design will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
28574|NCT02082158|P1|Participant Flow|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
28575|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 4 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28576|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 3 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28577|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 2 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28578|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 1 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28579|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to a non-local respirator model will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
28580|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
28581|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28582|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28583|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28584|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28585|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to the non-local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28586|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
28587|NCT02082158|E6|Reported Event|Prototype 4 Respirator Design|Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
28588|NCT02082158|E5|Reported Event|Prototype 3 Respirator Design|Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
28589|NCT02082158|E4|Reported Event|Prototype 2 Respirator Design|Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
28590|NCT02082158|E3|Reported Event|Prototype 1 Respirator Design|Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
28591|NCT02082158|E2|Reported Event|Non-Local Respirator Model|Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
29603|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
28592|NCT02082158|E1|Reported Event|Local Respirator Model|Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
28593|NCT02081599|B3|Baseline|Total|Total of all reporting groups
28594|NCT02081599|B2|Baseline|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28595|NCT02081599|B1|Baseline|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28596|NCT02081599|P2|Participant Flow|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28597|NCT02081599|P1|Participant Flow|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28598|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28599|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28600|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28601|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28602|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28603|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28604|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28605|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
28606|NCT02081599|E4|Reported Event|Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
28607|NCT02081599|E3|Reported Event|Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
28608|NCT02081599|E2|Reported Event|Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
28609|NCT02081599|E1|Reported Event|Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
28610|NCT02081365|B3|Baseline|Total|Total of all reporting groups
28611|NCT02081365|B2|Baseline|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28612|NCT02081365|B1|Baseline|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28666|NCT02081079|E1|Reported Event|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
28667|NCT02081014|B1|Baseline|Total Study Group|Includes all 12 treated subjects
28763|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28613|NCT02081365|P2|Participant Flow|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28614|NCT02081365|P1|Participant Flow|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28615|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28616|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28617|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28618|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28619|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28620|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28621|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28622|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28623|NCT02081365|E2|Reported Event|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28624|NCT02081365|E1|Reported Event|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
28625|NCT02081183|B3|Baseline|Total|Total of all reporting groups
28764|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28626|NCT02081183|B2|Baseline|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28627|NCT02081183|B1|Baseline|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28628|NCT02081183|P2|Participant Flow|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28629|NCT02081183|P1|Participant Flow|Mycophenolate Mofetil (MMF), Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28630|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28631|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28632|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28633|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28634|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28635|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28636|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28668|NCT02081014|P6|Participant Flow|G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
28637|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28638|NCT02081183|E2|Reported Event|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28639|NCT02081183|E1|Reported Event|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
28640|NCT02081079|B5|Baseline|Total|Total of all reporting groups
28641|NCT02081079|B4|Baseline|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
28642|NCT02081079|B3|Baseline|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
28643|NCT02081079|B2|Baseline|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
28644|NCT02081079|B1|Baseline|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
28645|NCT02081079|P2|Participant Flow|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
28646|NCT02081079|P1|Participant Flow|Genotype 4|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
28647|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
28648|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
28649|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
28650|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
28651|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
28652|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
28653|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
28654|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
28655|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
28656|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
28657|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
28658|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
28659|NCT02081079|O2|Outcome|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
28660|NCT02081079|O1|Outcome|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
28661|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
28662|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
28663|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
28664|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
28665|NCT02081079|E2|Reported Event|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
28669|NCT02081014|P5|Participant Flow|G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
28670|NCT02081014|P4|Participant Flow|G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
28671|NCT02081014|P3|Participant Flow|G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
28672|NCT02081014|P2|Participant Flow|G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
28673|NCT02081014|P1|Participant Flow|G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
28674|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28675|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28676|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28677|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
28678|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
28679|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
28680|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28681|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28682|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28683|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
28684|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
28685|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
28686|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28687|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28688|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28689|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
28690|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
28691|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
28692|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28693|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28694|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28695|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
28696|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
28697|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
28698|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28699|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
29604|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
28700|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28701|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
28702|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
28703|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
28704|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28705|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28706|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
28707|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
28708|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
28709|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
28710|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
28711|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
28712|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
28713|NCT02081014|E3|Reported Event|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
28714|NCT02081014|E2|Reported Event|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
28715|NCT02081014|E1|Reported Event|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
28716|NCT02081001|B3|Baseline|Total|Total of all reporting groups
28717|NCT02081001|B2|Baseline|GlucaGen First, Followed by Xeris G-Pump|Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
28718|NCT02081001|B1|Baseline|Xeris G-Pump Glucagon First, Followed by GlucaGen|Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.
28719|NCT02081001|P12|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28720|NCT02081001|P11|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28721|NCT02081001|P10|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28722|NCT02081001|P9|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28723|NCT02081001|P8|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28724|NCT02081001|P7|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28760|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28761|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28762|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28725|NCT02081001|P6|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28726|NCT02081001|P5|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28727|NCT02081001|P4|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28728|NCT02081001|P3|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28729|NCT02081001|P2|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
28730|NCT02081001|P1|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
28731|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28732|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28733|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28734|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28735|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28736|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28737|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28738|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28739|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28740|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28741|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28742|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28743|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28744|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28745|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28746|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28747|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28748|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28749|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28750|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28751|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28752|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28753|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28754|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28755|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28756|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28757|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28758|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28759|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
63427|NCT01789476|O1|Outcome|Placebo|Matched placebo
28765|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28766|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28767|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28768|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28769|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28770|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28771|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28772|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28773|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28774|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28775|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28776|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28777|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28778|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28779|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28780|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28781|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28782|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28783|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28784|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28785|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28786|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28787|NCT02081001|O4|Outcome|0.3μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
28788|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28789|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28790|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
28791|NCT02081001|E2|Reported Event|Novo Nordisk GlucaGen®|Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
28792|NCT02081001|E1|Reported Event|G-Pump™ (Glucagon Infusion)|G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump
28793|NCT02080780|B1|Baseline|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
28794|NCT02080780|P1|Participant Flow|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
28795|NCT02080780|O2|Outcome|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
28796|NCT02080780|O1|Outcome|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
28797|NCT02080780|E3|Reported Event|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
28798|NCT02080780|E2|Reported Event|Clarithromycin XL (Days 4-9)|On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses.
28799|NCT02080780|E1|Reported Event|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
28800|NCT02080546|B3|Baseline|Total|Total of all reporting groups
28801|NCT02080546|B2|Baseline|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28802|NCT02080546|B1|Baseline|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28977|NCT02076919|O7|Outcome|Vehicle, Part 2|One drop instilled in the study eye once, twice, or three times daily for 7 days
28803|NCT02080546|P2|Participant Flow|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28804|NCT02080546|P1|Participant Flow|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28805|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28806|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28807|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28808|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28809|NCT02080546|E2|Reported Event|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28810|NCT02080546|E1|Reported Event|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
28811|NCT02080312|B1|Baseline|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
28812|NCT02080312|P1|Participant Flow|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
28813|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
28814|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
28815|NCT02080312|O1|Outcome|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
28816|NCT02080312|E1|Reported Event|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
28817|NCT02080091|B1|Baseline|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28818|NCT02080091|P1|Participant Flow|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28819|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28820|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28821|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28822|NCT02080091|E1|Reported Event|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
28823|NCT02079844|B4|Baseline|Total|Total of all reporting groups
28824|NCT02079844|B3|Baseline|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28846|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28825|NCT02079844|B2|Baseline|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28826|NCT02079844|B1|Baseline|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28827|NCT02079844|P3|Participant Flow|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28828|NCT02079844|P2|Participant Flow|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28829|NCT02079844|P1|Participant Flow|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28830|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28831|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28832|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28833|NCT02079844|O3|Outcome|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28834|NCT02079844|O2|Outcome|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28835|NCT02079844|O1|Outcome|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28836|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28837|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28838|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28839|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28840|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28841|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28842|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28843|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28844|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28845|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28847|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28848|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28849|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28850|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28851|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28852|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28853|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28854|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28855|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28856|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28857|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28858|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28859|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28860|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28861|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28862|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28863|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28864|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28865|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28866|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28867|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28868|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28869|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28870|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28871|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28872|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28873|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28874|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28875|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28876|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
63428|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
28877|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28878|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28879|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28880|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28881|NCT02079844|E3|Reported Event|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28882|NCT02079844|E2|Reported Event|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28883|NCT02079844|E1|Reported Event|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
28884|NCT02079649|B5|Baseline|Total|Total of all reporting groups
28885|NCT02079649|B4|Baseline|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28886|NCT02079649|B3|Baseline|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28887|NCT02079649|B2|Baseline|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28888|NCT02079649|B1|Baseline|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28889|NCT02079649|P4|Participant Flow|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28890|NCT02079649|P3|Participant Flow|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28891|NCT02079649|P2|Participant Flow|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28892|NCT02079649|P1|Participant Flow|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28893|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28894|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28895|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28896|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28897|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28898|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28899|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28900|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
28901|NCT02079649|E5|Reported Event|Vehicle|Includes all subjects who were randomized to and treated with investigational product
28902|NCT02079649|E4|Reported Event|Maxidex|Includes all subjects who were randomized to and treated with investigational product
28903|NCT02079649|E3|Reported Event|AL-53817|Includes all subjects who were randomized to and treated with investigational product
28904|NCT02079649|E2|Reported Event|AL-78843|Includes all subjects who were randomized to and treated with investigational product
28905|NCT02079649|E1|Reported Event|Pre-Treatment|Includes all subjects who consented to participate in the study
28906|NCT02079532|B1|Baseline|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28907|NCT02079532|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28908|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28909|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28910|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
63429|NCT01789476|O1|Outcome|Placebo|Matched placebo
28911|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28912|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28913|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28914|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28915|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28916|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28917|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28918|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28919|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28920|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28921|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28922|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28923|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28924|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28925|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28926|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28927|NCT02079532|E1|Reported Event|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
28928|NCT02079519|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
28929|NCT02079519|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
28930|NCT02079519|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
28931|NCT02079519|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
28932|NCT02079311|B3|Baseline|Total|Total of all reporting groups
28933|NCT02079311|B2|Baseline|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
28934|NCT02079311|B1|Baseline|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
28935|NCT02079311|P2|Participant Flow|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
28936|NCT02079311|P1|Participant Flow|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
28937|NCT02079311|O2|Outcome|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
28938|NCT02079311|O1|Outcome|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
28939|NCT02079311|E2|Reported Event|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
28940|NCT02079311|E1|Reported Event|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
28941|NCT02077374|B3|Baseline|Total|Total of all reporting groups
28942|NCT02077374|B2|Baseline|Placebo|"Placebo~Matching Placebo BID for 28 days"
28943|NCT02077374|B1|Baseline|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28944|NCT02077374|P2|Participant Flow|Placebo|"Placebo~Matching Placebo BID for 28 days"
28945|NCT02077374|P1|Participant Flow|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28946|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo BID for 28 Days"
28947|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28948|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
28949|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28950|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
28951|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28952|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
28953|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28954|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo Twice daily for 28 Days"
28955|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg Twice daily for 28 days"
28956|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
28957|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28958|NCT02077374|E2|Reported Event|Placebo|"Placebo~Matching Placebo BID for 28 days"
28959|NCT02077374|E1|Reported Event|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
28960|NCT02076919|B13|Baseline|Total|Total of all reporting groups
28961|NCT02076919|B12|Baseline|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
28962|NCT02076919|B11|Baseline|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
28963|NCT02076919|B10|Baseline|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
28964|NCT02076919|B9|Baseline|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28965|NCT02076919|B8|Baseline|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28966|NCT02076919|B7|Baseline|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28967|NCT02076919|B6|Baseline|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28968|NCT02076919|B5|Baseline|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
28969|NCT02076919|B4|Baseline|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
28970|NCT02076919|B3|Baseline|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
28971|NCT02076919|B2|Baseline|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
28972|NCT02076919|B1|Baseline|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
28973|NCT02076919|P4|Participant Flow|Vehicle, Part 2|Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
28974|NCT02076919|P3|Participant Flow|LHA510, Part 2|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
28975|NCT02076919|P2|Participant Flow|Vehicle, Part 1|Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
28976|NCT02076919|P1|Participant Flow|LHA510, Part 1|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
28978|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
28979|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
28980|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28981|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28982|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28983|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28984|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
28985|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
28986|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
28987|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28988|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28989|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28990|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28991|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
28992|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
28993|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
28994|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28995|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
28996|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28997|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
28998|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
28999|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29000|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29001|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29002|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29003|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
29004|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29005|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29006|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29007|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29008|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
29009|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29010|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29011|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29012|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29013|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29014|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29015|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
29016|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29017|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29018|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29019|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29020|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
29021|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29022|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29023|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29024|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29025|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29026|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29027|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29028|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29029|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29030|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29031|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29032|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29033|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29034|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29035|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29036|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29037|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29038|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29039|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29040|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29041|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29042|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29043|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29044|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29045|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29046|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29047|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29048|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29049|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
29050|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29051|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29052|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29053|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29054|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29055|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29056|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
29057|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29058|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29059|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29060|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29061|NCT02076919|E12|Reported Event|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
29062|NCT02076919|E11|Reported Event|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
29063|NCT02076919|E10|Reported Event|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
29064|NCT02076919|E9|Reported Event|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29065|NCT02076919|E8|Reported Event|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
29066|NCT02076919|E7|Reported Event|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29067|NCT02076919|E6|Reported Event|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
29068|NCT02076919|E5|Reported Event|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
29069|NCT02076919|E4|Reported Event|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
29070|NCT02076919|E3|Reported Event|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
29071|NCT02076919|E2|Reported Event|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
29072|NCT02076919|E1|Reported Event|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
29073|NCT02076009|B3|Baseline|Total|Total of all reporting groups
29074|NCT02076009|B2|Baseline|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29075|NCT02076009|B1|Baseline|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29076|NCT02076009|P2|Participant Flow|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29077|NCT02076009|P1|Participant Flow|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29078|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29079|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29080|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29081|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29082|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29083|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29084|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29085|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29086|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29087|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29088|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29089|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29090|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29091|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29092|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29093|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29139|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29140|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
63430|NCT01789476|E2|Reported Event|Placebo|Matched placebo
29094|NCT02076009|E2|Reported Event|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
29095|NCT02076009|E1|Reported Event|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
29096|NCT02075632|B3|Baseline|Total|Total of all reporting groups
29097|NCT02075632|B2|Baseline|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used
29098|NCT02075632|B1|Baseline|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29099|NCT02075632|P2|Participant Flow|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
29100|NCT02075632|P1|Participant Flow|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29101|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
29102|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29103|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
29104|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29105|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
29106|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29107|NCT02075632|E2|Reported Event|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
29108|NCT02075632|E1|Reported Event|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
29109|NCT02075411|B5|Baseline|Total|Total of all reporting groups
29110|NCT02075411|B4|Baseline|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29111|NCT02075411|B3|Baseline|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29112|NCT02075411|B2|Baseline|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29113|NCT02075411|B1|Baseline|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29114|NCT02075411|P4|Participant Flow|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29115|NCT02075411|P3|Participant Flow|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29116|NCT02075411|P2|Participant Flow|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29117|NCT02075411|P1|Participant Flow|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29141|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29142|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29118|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29119|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29120|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29121|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29122|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29123|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29124|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29125|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29126|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29127|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29128|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29129|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29130|NCT02075411|E4|Reported Event|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29131|NCT02075411|E3|Reported Event|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
29132|NCT02075411|E2|Reported Event|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
29133|NCT02075411|E1|Reported Event|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
29134|NCT02075125|B3|Baseline|Total|Total of all reporting groups
29135|NCT02075125|B2|Baseline|Ticagrelor|Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29136|NCT02075125|B1|Baseline|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29137|NCT02075125|P2|Participant Flow|Ticagrelor|Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
29138|NCT02075125|P1|Participant Flow|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29605|NCT02073448|E3|Reported Event|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29143|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29144|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29145|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29146|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29147|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29148|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29149|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29150|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29151|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29152|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29153|NCT02075125|E2|Reported Event|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
29154|NCT02075125|E1|Reported Event|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
29155|NCT02075073|B4|Baseline|Total|Total of all reporting groups
29156|NCT02075073|B3|Baseline|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29157|NCT02075073|B2|Baseline|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29158|NCT02075073|B1|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29159|NCT02075073|P3|Participant Flow|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29160|NCT02075073|P2|Participant Flow|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29161|NCT02075073|P1|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29162|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29163|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29164|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29165|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29166|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29167|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29168|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29169|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29170|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29171|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29172|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29173|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29174|NCT02075073|E3|Reported Event|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
29175|NCT02075073|E2|Reported Event|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
29176|NCT02075073|E1|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
29177|NCT02074995|B1|Baseline|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29178|NCT02074995|P3|Participant Flow|BVS857 Group 1B/1C, 2, 3, 4 Double Blind|
29179|NCT02074995|P2|Participant Flow|Placebo Group 1B/1C, 2, 3, 4|
29180|NCT02074995|P1|Participant Flow|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29181|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29182|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29183|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29184|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29185|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29186|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29187|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29188|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29189|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29190|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29191|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29192|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29193|NCT02074995|E1|Reported Event|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
29194|NCT02074709|B3|Baseline|Total|Total of all reporting groups
29195|NCT02074709|B2|Baseline|Wound Infiltration|Wound infiltration with liposomal bupivacaine
29196|NCT02074709|B1|Baseline|TAP Block|TAP block with plain bupivacaine
29197|NCT02074709|P2|Participant Flow|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
29198|NCT02074709|P1|Participant Flow|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
29199|NCT02074709|O2|Outcome|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV"
29200|NCT02074709|O1|Outcome|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV ."
29201|NCT02074709|E2|Reported Event|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
29202|NCT02074709|E1|Reported Event|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
29203|NCT02074553|B3|Baseline|Total|Total of all reporting groups
29204|NCT02074553|B2|Baseline|Part 2 (Fed): Study Population|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
29205|NCT02074553|B1|Baseline|Part 1 (Fasted): Study Population|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
29206|NCT02074553|P8|Participant Flow|Part 2 (Fed): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29207|NCT02074553|P7|Participant Flow|Part 2 (Fed): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29208|NCT02074553|P6|Participant Flow|Part 2 (Fed): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29224|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29421|NCT02074384|O2|Outcome|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
29209|NCT02074553|P5|Participant Flow|Part 2 (Fed): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29210|NCT02074553|P4|Participant Flow|Part 1 (Fasted): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29211|NCT02074553|P3|Participant Flow|Part 1 (Fasted): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29212|NCT02074553|P2|Participant Flow|Part 1 (Fasted): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29213|NCT02074553|P1|Participant Flow|Part 1 (Fasted): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent [%]sodium lauryl sulfate [SLS]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
29214|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29215|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29216|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29217|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29218|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29219|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29220|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29221|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29222|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29223|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29316|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29225|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29226|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29227|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29228|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29229|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29230|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29231|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29232|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29233|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29234|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29235|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29236|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29237|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29238|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29239|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29240|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29241|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29242|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29243|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29244|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29245|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29246|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29247|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29587|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29248|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29249|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29250|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29251|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29252|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29253|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29254|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29255|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29256|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29257|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29258|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29259|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29260|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29261|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29262|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29263|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29264|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29265|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29266|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29267|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29268|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29269|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29270|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29588|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
29271|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29272|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29273|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29274|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29275|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29276|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29277|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29278|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29279|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29280|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29281|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29282|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29283|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29284|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29285|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29286|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29287|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29288|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29289|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29290|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29291|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29292|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29293|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
63431|NCT01789476|E1|Reported Event|CR845|CR845 (0.005 mg/kg) IV
29294|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29295|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29296|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29297|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29298|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29299|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29300|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29301|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29302|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29303|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29304|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29305|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29306|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29307|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29308|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29309|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29310|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29311|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29312|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29313|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29314|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29315|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29417|NCT02074384|P3|Participant Flow|Clinicians|Clinicians completing study AGP visits.
29589|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29317|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29318|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29319|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29320|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29321|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29322|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29323|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29324|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29325|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29326|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29327|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29328|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29329|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29330|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29331|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29332|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29333|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29334|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29335|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29336|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29337|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29338|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29418|NCT02074384|P2|Participant Flow|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
29339|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29340|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29341|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29342|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29343|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29344|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29345|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29346|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29347|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29348|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29349|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29350|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29351|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29352|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29353|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29354|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29355|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29356|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29357|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29358|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29359|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29360|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29419|NCT02074384|P1|Participant Flow|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
29420|NCT02074384|O3|Outcome|Clinicians|Clinicians completing the study visits.
29361|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29362|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29363|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29364|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29365|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29366|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29367|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29368|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29369|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29370|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29371|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29372|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29373|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29374|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29375|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29376|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29377|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29378|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29379|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29380|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29381|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29382|NCT02074553|E8|Reported Event|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
29383|NCT02074553|E7|Reported Event|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
29384|NCT02074553|E6|Reported Event|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
29385|NCT02074553|E5|Reported Event|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
29386|NCT02074553|E4|Reported Event|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
29387|NCT02074553|E3|Reported Event|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
29388|NCT02074553|E2|Reported Event|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
29389|NCT02074553|E1|Reported Event|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
29390|NCT02074514|B5|Baseline|Total|Total of all reporting groups
29391|NCT02074514|B4|Baseline|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
29392|NCT02074514|B3|Baseline|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
29393|NCT02074514|B2|Baseline|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
29394|NCT02074514|B1|Baseline|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
29395|NCT02074514|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
29396|NCT02074514|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
29397|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
29398|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
29399|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
29400|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
29401|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
29402|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
29403|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
29404|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
29405|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
29406|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
29407|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
29408|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
29409|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
29410|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
29411|NCT02074514|E2|Reported Event|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
29412|NCT02074514|E1|Reported Event|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
29413|NCT02074384|B4|Baseline|Total|Total of all reporting groups
29414|NCT02074384|B3|Baseline|Clinicians|Clinicians completing the study visits.
29415|NCT02074384|B2|Baseline|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
29416|NCT02074384|B1|Baseline|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
29422|NCT02074384|O1|Outcome|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
29423|NCT02074384|E3|Reported Event|Clinicians|"Clinicians completing study visits.~Clinician: Survey of clinicians after study visits"
29424|NCT02074384|E2|Reported Event|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
29425|NCT02074384|E1|Reported Event|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
29426|NCT02074358|B1|Baseline|All Treated Participants|Treated population included all participants who received at least one dose of study medication. Participants received 10 mg apixaban BID on Days 1-3 and on Day 4 received a single dose of 10 mg apixaban followed 3 hours later by an IV infusion of 50 IU/kg prothrombin complex concentrate (PCC) (which was either Cofact or Beriplex P/N) or the participant received an IV infusion of placebo (saline solution). Participants were randomized on Day 1 to one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). There were 3 treatment periods with a total of 3 participants in each of 3 sequences (ABC, ACB, CAB) and 2 participants in each of 3 other sequences (CBA, BAC, BCA) for a total of 15 participants who participated in this open label, randomized, crossover study.
29427|NCT02074358|P6|Participant Flow|Treatment CBA|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
29428|NCT02074358|P5|Participant Flow|Treatment CAB|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
29429|NCT02074358|P4|Participant Flow|Treatment BCA|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
29430|NCT02074358|P3|Participant Flow|Treatment BAC|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
29431|NCT02074358|P2|Participant Flow|Treatment ACB|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
29432|NCT02074358|P1|Participant Flow|Treatment ABC|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID) on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours (hrs) later by Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) intravenous infusion (IV) for 30 minutes.~Treatment B: Apixaban + Cofact [4-Factor prothrombin complex concentrate (PCC)]: Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 min."
29433|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29434|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29435|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29436|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29437|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29590|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29438|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29439|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29440|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29441|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29442|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29443|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29444|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29445|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29446|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29447|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29448|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29449|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29450|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29451|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29452|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29453|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29454|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29455|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29456|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29457|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29458|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29459|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29460|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29591|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
29592|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29461|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29462|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29463|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29464|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29465|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29466|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29467|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29468|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29469|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29470|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29471|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29472|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29473|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29474|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29475|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29476|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29477|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29478|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29479|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29480|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29481|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29482|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29483|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29593|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29594|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
29484|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29485|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29486|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29487|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29488|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29489|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29490|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29491|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29492|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29493|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29494|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29495|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29496|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29497|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29498|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29499|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29500|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29501|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29502|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29503|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29504|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29505|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29506|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29595|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29596|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29507|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29508|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29509|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29510|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29511|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29512|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29513|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29514|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29515|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29516|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29517|NCT02074358|E3|Reported Event|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
29518|NCT02074358|E2|Reported Event|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
29519|NCT02074358|E1|Reported Event|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
29520|NCT02074345|B1|Baseline|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29521|NCT02074345|P1|Participant Flow|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29522|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29523|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29524|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29525|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29526|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29527|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29528|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29529|NCT02074345|E1|Reported Event|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
29530|NCT02073656|B1|Baseline|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
29597|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
29531|NCT02073656|P1|Participant Flow|LDV/SOF 12 Weeks|"Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.~Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks."
29532|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
29533|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
29534|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
29535|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
29536|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29537|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29538|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29539|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29540|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29541|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29542|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29543|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29544|NCT02073656|E2|Reported Event|LDV/SOF+RBV 24 Weeks (Retreatment)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
29545|NCT02073656|E1|Reported Event|LDV/SOF 12 Weeks (Primary Study)|LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
29546|NCT02073461|B4|Baseline|Total|Total of all reporting groups
29547|NCT02073461|B3|Baseline|Vehicle|"Vehicle~Vehicle"
29548|NCT02073461|B2|Baseline|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29549|NCT02073461|B1|Baseline|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29550|NCT02073461|P3|Participant Flow|Vehicle|"Vehicle~Vehicle"
29551|NCT02073461|P2|Participant Flow|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29552|NCT02073461|P1|Participant Flow|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29553|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29554|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29555|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29556|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29557|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29558|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29559|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29560|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29561|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29562|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29563|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29564|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29565|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29566|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29567|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29568|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29569|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29570|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29571|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
29572|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29573|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29574|NCT02073461|E3|Reported Event|Vehicle|"Vehicle~Vehicle"
29575|NCT02073461|E2|Reported Event|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
29576|NCT02073461|E1|Reported Event|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
29577|NCT02073448|B4|Baseline|Total|Total of all reporting groups
29578|NCT02073448|B3|Baseline|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29579|NCT02073448|B2|Baseline|CD0271|"Adapalene 01% Gel~CD0271"
29580|NCT02073448|B1|Baseline|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29581|NCT02073448|P3|Participant Flow|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29582|NCT02073448|P2|Participant Flow|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29583|NCT02073448|P1|Participant Flow|CD0271|"Adapalene 01% Gel~CD0271"
29584|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
29585|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
29586|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29606|NCT02073448|E2|Reported Event|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
29607|NCT02073448|E1|Reported Event|CD0271|"Adapalene 01% Gel~CD0271"
29608|NCT02072980|B1|Baseline|Overall|Delefilcon A contact lenses worn during Period 1 and Period 2
29609|NCT02072980|P2|Participant Flow|15min/16hr|Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
29610|NCT02072980|P1|Participant Flow|16hr/15min|Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
29611|NCT02072980|O1|Outcome|15 Minutes|Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
29612|NCT02072980|O2|Outcome|Unworn|Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
29613|NCT02072980|O1|Outcome|16 Hours|Delefilcon A contact lenses worn for 16 hours in Period 1 or 2
29614|NCT02072980|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn during Period 1 and Period 2
29615|NCT02072421|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29616|NCT02072421|P1|Participant Flow|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29617|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29618|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29619|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29620|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
29621|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
29622|NCT02072421|E1|Reported Event|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
29623|NCT02072200|B1|Baseline|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29624|NCT02072200|P1|Participant Flow|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29625|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29626|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29627|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29628|NCT02072200|E1|Reported Event|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
29629|NCT02072096|B3|Baseline|Total|Total of all reporting groups
29630|NCT02072096|B2|Baseline|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
29631|NCT02072096|B1|Baseline|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29632|NCT02072096|P2|Participant Flow|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
29633|NCT02072096|P1|Participant Flow|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29634|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29635|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29636|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29637|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
29638|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29639|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29640|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29641|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
29642|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29643|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
29644|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29645|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29646|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29647|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29648|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29649|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29650|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29651|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29697|NCT02071108|B1|Baseline|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29698|NCT02071108|P1|Participant Flow|Lithoplasty Treatment|All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System
29652|NCT02072096|E2|Reported Event|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
29653|NCT02072096|E1|Reported Event|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
29654|NCT02071823|B3|Baseline|Total|Total of all reporting groups
29655|NCT02071823|B2|Baseline|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
29656|NCT02071823|B1|Baseline|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
29657|NCT02071823|P2|Participant Flow|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
29658|NCT02071823|P1|Participant Flow|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
29659|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
29660|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
29661|NCT02071823|O2|Outcome|Fasted Condition|Fasted condition period
29662|NCT02071823|O1|Outcome|Fed Conditions|Fed conditions period
29663|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
29664|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
29665|NCT02071823|E2|Reported Event|Fed Condition|Fed condition period
29666|NCT02071823|E1|Reported Event|Fasted Conditions|Fasted conditions period
29667|NCT02071810|B6|Baseline|Total|Total of all reporting groups
29668|NCT02071810|B5|Baseline|Placebo|"Placebo, PLC~Placebo"
29669|NCT02071810|B4|Baseline|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
29670|NCT02071810|B3|Baseline|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
29671|NCT02071810|B2|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
29672|NCT02071810|B1|Baseline|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
29673|NCT02071810|P5|Participant Flow|Placebo|"Placebo, PLC~Placebo"
29674|NCT02071810|P4|Participant Flow|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
29675|NCT02071810|P3|Participant Flow|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
29676|NCT02071810|P2|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
29677|NCT02071810|P1|Participant Flow|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
29678|NCT02071810|O5|Outcome|Placebo|"Placebo, PLC~Placebo"
29679|NCT02071810|O4|Outcome|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
29680|NCT02071810|O3|Outcome|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
29681|NCT02071810|O2|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
29682|NCT02071810|O1|Outcome|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
29683|NCT02071810|E5|Reported Event|Placebo|"Placebo, PLC~Placebo"
29684|NCT02071810|E4|Reported Event|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
29685|NCT02071810|E3|Reported Event|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
29686|NCT02071810|E2|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
29687|NCT02071810|E1|Reported Event|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
29688|NCT02071771|B1|Baseline|Overall|Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
29689|NCT02071771|P2|Participant Flow|1DAM A, Then DACP T|Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
29690|NCT02071771|P1|Participant Flow|DACP T, Then 1DAM A|Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
29691|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
29692|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
29693|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
29694|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
29695|NCT02071771|E2|Reported Event|1DAM A|Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
29696|NCT02071771|E1|Reported Event|DACP T|Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
29699|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29700|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29701|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29702|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29703|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29704|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29705|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29706|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29707|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29708|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29709|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29710|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29711|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29712|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29713|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29714|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29715|NCT02071108|E1|Reported Event|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
29716|NCT02071082|B3|Baseline|Total|Total of all reporting groups
29717|NCT02071082|B2|Baseline|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29718|NCT02071082|B1|Baseline|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29719|NCT02071082|P2|Participant Flow|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29720|NCT02071082|P1|Participant Flow|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
29721|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29722|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29723|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29724|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29725|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29726|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29727|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29728|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29729|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29730|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29731|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29732|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29733|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29734|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29735|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29736|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29737|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29738|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29739|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29802|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29740|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29741|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29742|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29743|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29744|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
29745|NCT02071082|E2|Reported Event|HIV-Suppressed|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
29746|NCT02071082|E1|Reported Event|HIV/HBV Treatment-Naive|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
29747|NCT02070640|B3|Baseline|Total|Total of all reporting groups
29748|NCT02070640|B2|Baseline|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29749|NCT02070640|B1|Baseline|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29750|NCT02070640|P2|Participant Flow|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29751|NCT02070640|P1|Participant Flow|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29752|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29753|NCT02070640|O1|Outcome|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29754|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29755|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29756|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29757|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29803|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29758|NCT02070640|E2|Reported Event|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29759|NCT02070640|E1|Reported Event|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
29760|NCT02070380|B5|Baseline|Total|Total of all reporting groups
29761|NCT02070380|B4|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
29762|NCT02070380|B3|Baseline|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
29763|NCT02070380|B2|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
29764|NCT02070380|B1|Baseline|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
29765|NCT02070380|P4|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
29766|NCT02070380|P3|Participant Flow|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
29767|NCT02070380|P2|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
29768|NCT02070380|P1|Participant Flow|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
29769|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29770|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29771|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29772|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29773|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29774|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29775|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29776|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29777|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29778|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29779|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29780|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29781|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29782|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29783|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29784|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29785|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29786|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29787|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29788|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29789|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29790|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29791|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29792|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29793|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29794|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29795|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29796|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29797|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29798|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29799|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29800|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29801|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29804|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29805|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29806|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29807|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29808|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29809|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29810|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
29811|NCT02070380|E4|Reported Event|Study Arm 2 / Dotarem 0.1 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105"
29812|NCT02070380|E3|Reported Event|Study Arm 2/ MultiHance 0.05 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg.~53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104"
29813|NCT02070380|E2|Reported Event|Study Arm 1 / Dotarem 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70"
29814|NCT02070380|E1|Reported Event|Study Arm 1 / MultiHance 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg.~31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65"
29815|NCT02070237|B3|Baseline|Total|Total of all reporting groups
29816|NCT02070237|B2|Baseline|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29817|NCT02070237|B1|Baseline|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29818|NCT02070237|P2|Participant Flow|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29819|NCT02070237|P1|Participant Flow|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29820|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29821|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29822|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29823|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29824|NCT02070237|E2|Reported Event|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29844|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29977|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29825|NCT02070237|E1|Reported Event|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
29826|NCT02069093|B1|Baseline|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29827|NCT02069093|P1|Participant Flow|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29828|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29829|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29830|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29831|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29832|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29833|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29834|NCT02069093|E1|Reported Event|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
29835|NCT02068443|B4|Baseline|Total|Total of all reporting groups
29836|NCT02068443|B3|Baseline|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29837|NCT02068443|B2|Baseline|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29838|NCT02068443|B1|Baseline|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29839|NCT02068443|P3|Participant Flow|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29840|NCT02068443|P2|Participant Flow|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29841|NCT02068443|P1|Participant Flow|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29842|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29843|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29978|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29845|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29846|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29847|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29848|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29849|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29850|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29851|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29852|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29853|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29854|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29855|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29856|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29857|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29858|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29859|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29860|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29861|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29862|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29863|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29864|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29865|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29866|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29908|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29867|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29868|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29869|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29870|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29871|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29872|NCT02068443|E3|Reported Event|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
29873|NCT02068443|E2|Reported Event|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
29874|NCT02068443|E1|Reported Event|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
29875|NCT02068222|B1|Baseline|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29876|NCT02068222|P1|Participant Flow|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29877|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29878|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29879|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29880|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
29881|NCT02068222|E1|Reported Event|ABT-450/r and ABT-530 Plus RBV|ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
29882|NCT02067728|B3|Baseline|Total|Total of all reporting groups
29883|NCT02067728|B2|Baseline|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29884|NCT02067728|B1|Baseline|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29885|NCT02067728|P2|Participant Flow|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29886|NCT02067728|P1|Participant Flow|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29887|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29888|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29971|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29972|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29889|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29890|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29891|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29892|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29893|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29894|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29895|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29896|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29897|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29898|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29899|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29900|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29901|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29902|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29903|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29904|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29905|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29906|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29907|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29973|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29909|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29910|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29911|NCT02067728|E2|Reported Event|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
29912|NCT02067728|E1|Reported Event|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
29913|NCT02067533|B3|Baseline|Total|Total of all reporting groups
29914|NCT02067533|B2|Baseline|Extension Position|soft tissue repair in extension position
29915|NCT02067533|B1|Baseline|Flexion Position|soft tissue repair in flexion position
29916|NCT02067533|P2|Participant Flow|Extension Position|soft tissue repair in extension position
29917|NCT02067533|P1|Participant Flow|Flexion Position|soft tissue repair in flexion position
29918|NCT02067533|O2|Outcome|Extension Position|soft tissue repair in extension position
29919|NCT02067533|O1|Outcome|Flexion Position|soft tissue repair in flexion position
29920|NCT02067533|E2|Reported Event|Extension Position|soft tissue repair in extension position
29921|NCT02067533|E1|Reported Event|Flexion Position|soft tissue repair in flexion position
29922|NCT02066922|B1|Baseline|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
29923|NCT02066922|P1|Participant Flow|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
29924|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
29925|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
29926|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
29927|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
29928|NCT02066922|E2|Reported Event|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
29929|NCT02066922|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
29930|NCT02066740|B1|Baseline|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
29931|NCT02066740|P1|Participant Flow|EverFlex™ Stent With Entrust™ Delivery System|Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
29932|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
29933|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
29934|NCT02066740|E1|Reported Event|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
29935|NCT02066727|B3|Baseline|Total|Total of all reporting groups
29936|NCT02066727|B2|Baseline|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
29937|NCT02066727|B1|Baseline|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
29938|NCT02066727|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
29939|NCT02066727|P1|Participant Flow|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
29940|NCT02066727|O2|Outcome|Dexmedetomidine|"Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.~Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg."
29941|NCT02066727|O1|Outcome|Normal Saline|"Normal Saline is administrated as an adjuvant of lidocaine.~Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine."
29942|NCT02066727|E2|Reported Event|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
29943|NCT02066727|E1|Reported Event|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
29944|NCT02066051|B1|Baseline|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
29974|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29975|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29976|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30140|NCT02064231|O2|Outcome|Coloplast Test B|Subjects testing Test B
29945|NCT02066051|P1|Participant Flow|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
29946|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
29947|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
29948|NCT02066051|E1|Reported Event|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
29949|NCT02064985|B4|Baseline|Total|Total of all reporting groups
29950|NCT02064985|B3|Baseline|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29951|NCT02064985|B2|Baseline|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29952|NCT02064985|B1|Baseline|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29953|NCT02064985|P3|Participant Flow|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29954|NCT02064985|P2|Participant Flow|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29955|NCT02064985|P1|Participant Flow|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29956|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29957|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29958|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29959|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29960|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29961|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29962|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29963|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29964|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29965|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29966|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29967|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29968|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29969|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29970|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29979|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29980|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29981|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29982|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29983|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29984|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29985|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29986|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29987|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29988|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29989|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29990|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29991|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29992|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29993|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29994|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29995|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29996|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
29997|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
29998|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
29999|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30000|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30001|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30002|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30003|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30004|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30005|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30006|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30007|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30008|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30009|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30010|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30011|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30012|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30013|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30014|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30015|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30016|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30017|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30018|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30019|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30141|NCT02064231|O1|Outcome|Coloplast Test A|Subjects testing Test A
30020|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30021|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30022|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30023|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30024|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30025|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30026|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30027|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30028|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30029|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30030|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30031|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30032|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30033|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30034|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30035|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30036|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30037|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30038|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30039|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30040|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30041|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30042|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30043|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30044|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30045|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30046|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30047|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30048|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30049|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30050|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30051|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30052|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30053|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30054|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30055|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30056|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30057|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30058|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30059|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30060|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30142|NCT02064231|E5|Reported Event|Own Product|Subjects collecting data on own product
30061|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30062|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30063|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30064|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30065|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30066|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30067|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30068|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30069|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30070|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30071|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30072|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30073|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30074|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30075|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30076|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30077|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30078|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30079|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30080|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30081|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30082|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30083|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30084|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30085|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30086|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30087|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30088|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30089|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30090|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30091|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30092|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30093|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30094|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30095|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30096|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30097|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30098|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30099|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30100|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30101|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30143|NCT02064231|E4|Reported Event|Coloplast Test D|Subjects testing Test D
30102|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30103|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30104|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30105|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30106|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30107|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30108|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30109|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30110|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30111|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30112|NCT02064985|E3|Reported Event|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
30113|NCT02064985|E2|Reported Event|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
30114|NCT02064985|E1|Reported Event|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
30115|NCT02064907|B3|Baseline|Total|Total of all reporting groups
30116|NCT02064907|B2|Baseline|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
30117|NCT02064907|B1|Baseline|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
30118|NCT02064907|P2|Participant Flow|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
30119|NCT02064907|P1|Participant Flow|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
30120|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30121|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30122|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30123|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30124|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30125|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30126|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30127|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30128|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30129|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30130|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30131|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30132|NCT02064907|E2|Reported Event|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
30133|NCT02064907|E1|Reported Event|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
30134|NCT02064231|B1|Baseline|Overall Study Population|
30135|NCT02064231|P2|Participant Flow|Coloplast Test C , Coloplast Test D, Own Product|"The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.~Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S"
30136|NCT02064231|P1|Participant Flow|Coloplast Test A, Coloplast Test B, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
30137|NCT02064231|O5|Outcome|Own Product|Subjects collecting data on own product
30138|NCT02064231|O4|Outcome|Coloplast Test D|Subjects testing Test D
30139|NCT02064231|O3|Outcome|Coloplast Test C|Subjects testing Test C
30144|NCT02064231|E3|Reported Event|Coloplast Test C|Subjects testing Test C
30145|NCT02064231|E2|Reported Event|Coloplast Test B|Subjects testing Test B
30146|NCT02064231|E1|Reported Event|Coloplast Test A|Subjects testing Test A
30147|NCT02064205|B1|Baseline|Overall Baseline Charactistics of 32 Slightly Overweight Women|Baseline data of the subjects were measured at screening at least one week before the start of the study.
30148|NCT02064205|P1|Participant Flow|All Study Participants|"A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min~Eight orders:~A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B."
30149|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
30150|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|Breakfast with polydextrose and yogurt provided four hours before lunch.
30151|NCT02064205|O4|Outcome|Pre-load With Glucose Syrup Before Lunch [D]|Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.
30152|NCT02064205|O3|Outcome|Pre-load With Polydextrose Before Lunch [C]|Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch
30153|NCT02064205|O2|Outcome|Glucose Syrup as Proload With Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
30154|NCT02064205|O1|Outcome|Polydextrose Syrup Preload With Yogurt With Breakfast [A]|Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch
30155|NCT02064205|O4|Outcome|Pre-load With Yogurt and Glucose Before Lunch [D]|"Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.~Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch"
30156|NCT02064205|O3|Outcome|Pre-load With Polydextroseglucose Before Lunch [C]|"Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch."
30157|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|"Breakfast with control pre-load four hours before lunch~Yogurt with control (glucose syrup) is tested for its satiating effect.~glucose syrup: Glucose syrup is used a control product for the polydextrose"
30158|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|"Breakfast with pre-load four hours before lunch~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch."
30159|NCT02064205|E4|Reported Event|Condition D|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
30160|NCT02064205|E3|Reported Event|Condition C|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
30161|NCT02064205|E2|Reported Event|Condition B|Breakfast with preload of yogurt and glucose control
30162|NCT02064205|E1|Reported Event|Condition A|Breakfast with preload of yogurt and polydextrose
30163|NCT02063737|B3|Baseline|Total|Total of all reporting groups
30164|NCT02063737|B2|Baseline|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30165|NCT02063737|B1|Baseline|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30166|NCT02063737|P2|Participant Flow|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30167|NCT02063737|P1|Participant Flow|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30168|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30169|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
63839|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
30170|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30171|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30172|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30173|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30174|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30175|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30176|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30177|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30178|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30179|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30180|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30252|NCT02062905|P1|Participant Flow|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
65611|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
30181|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30182|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30183|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30184|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30185|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30186|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30187|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30188|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30189|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30190|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30191|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30206|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30253|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
30192|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30193|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30194|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30195|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30196|NCT02063737|E2|Reported Event|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
30197|NCT02063737|E1|Reported Event|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
30198|NCT02063516|B3|Baseline|Total|Total of all reporting groups
30199|NCT02063516|B2|Baseline|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30200|NCT02063516|B1|Baseline|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30201|NCT02063516|P2|Participant Flow|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30202|NCT02063516|P1|Participant Flow|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30203|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30204|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30205|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30207|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30254|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
30255|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
30319|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
30208|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30209|NCT02063516|E2|Reported Event|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
30210|NCT02063516|E1|Reported Event|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
30211|NCT02063230|B5|Baseline|Total|Total of all reporting groups
30212|NCT02063230|B4|Baseline|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30213|NCT02063230|B3|Baseline|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30214|NCT02063230|B2|Baseline|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30215|NCT02063230|B1|Baseline|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30216|NCT02063230|P4|Participant Flow|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30217|NCT02063230|P3|Participant Flow|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30218|NCT02063230|P2|Participant Flow|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30219|NCT02063230|P1|Participant Flow|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30220|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30221|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30222|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30223|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30224|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30225|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30226|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30227|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30228|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30229|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30230|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30231|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30232|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30233|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30234|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30235|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30236|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30237|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30238|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30239|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30240|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30241|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30242|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30243|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30244|NCT02063230|E4|Reported Event|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
30245|NCT02063230|E3|Reported Event|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
30246|NCT02063230|E2|Reported Event|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
30247|NCT02063230|E1|Reported Event|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
30248|NCT02062905|B3|Baseline|Total|Total of all reporting groups
30249|NCT02062905|B2|Baseline|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
30250|NCT02062905|B1|Baseline|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
30251|NCT02062905|P2|Participant Flow|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
66374|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
30256|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
30257|NCT02062905|E2|Reported Event|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
30258|NCT02062905|E1|Reported Event|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
30259|NCT02062801|B3|Baseline|Total|Total of all reporting groups
30260|NCT02062801|B2|Baseline|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30261|NCT02062801|B1|Baseline|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30262|NCT02062801|P2|Participant Flow|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30263|NCT02062801|P1|Participant Flow|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30264|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30265|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30266|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30267|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30268|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30269|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30270|NCT02062801|E2|Reported Event|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
30271|NCT02062801|E1|Reported Event|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
30272|NCT02062710|B1|Baseline|Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine~Dextromethorphan: 30 mg dose dextromethorphan"
30273|NCT02062710|P6|Participant Flow|Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/|"placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods."
30274|NCT02062710|P5|Participant Flow|Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho|"placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods"
30275|NCT02062710|P4|Participant Flow|Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/|"dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods"
30276|NCT02062710|P3|Participant Flow|Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl|dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion
30277|NCT02062710|P2|Participant Flow|Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro|"diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge testing after study drug ingestion"
30278|NCT02062710|P1|Participant Flow|Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Washout 1-2 days between each of the 3 dosing periods."
30279|NCT02062710|O3|Outcome|Placebo|placebo liquid, dextrose in water, 20 mL
30280|NCT02062710|O2|Outcome|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
30281|NCT02062710|O1|Outcome|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
30282|NCT02062710|E3|Reported Event|Placebo|placebo liquid, dextrose in water, 20 mL
30283|NCT02062710|E2|Reported Event|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
30284|NCT02062710|E1|Reported Event|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
30317|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
30318|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
30285|NCT02062658|B1|Baseline|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
30286|NCT02062658|P1|Participant Flow|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
30287|NCT02062658|O1|Outcome|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
30288|NCT02062658|E1|Reported Event|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
30289|NCT02062502|B3|Baseline|Total|Total of all reporting groups
30290|NCT02062502|B2|Baseline|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30291|NCT02062502|B1|Baseline|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30292|NCT02062502|P2|Participant Flow|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30293|NCT02062502|P1|Participant Flow|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30294|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30295|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30296|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30297|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30298|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30299|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30300|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30301|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30302|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30303|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30304|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30305|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30306|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30307|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30308|NCT02062502|E2|Reported Event|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30309|NCT02062502|E1|Reported Event|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
30310|NCT02062450|B3|Baseline|Total|Total of all reporting groups
30311|NCT02062450|B2|Baseline|Revision Surgery|Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
30312|NCT02062450|B1|Baseline|Primary Surgery|Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
30313|NCT02062450|P1|Participant Flow|Hip Acetabular Replacement, Using a Dual Mobility Cup.|"Studied cohort includes 2 subgroups :~Patients with primary hip replacement.~Patients with revision surgery."
30314|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
30315|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
30316|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
66375|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
30320|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
30321|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
30322|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
30323|NCT02062450|E3|Reported Event|Revision Surgery Sub-group|Patients who underwent a Revision Hip Replacement surgery
30324|NCT02062450|E2|Reported Event|Primary Surgery Sub-group|Patients who underwent a Primary Hip Replacement surgery
30325|NCT02062450|E1|Reported Event|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
30326|NCT02062437|B1|Baseline|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30327|NCT02062437|P1|Participant Flow|Total Hip Replacement Using a Ceramic Friction Pair|All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
30328|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30329|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30330|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30331|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30332|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30333|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30334|NCT02062437|E1|Reported Event|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
30335|NCT02062385|B5|Baseline|Total|Total of all reporting groups
30336|NCT02062385|B4|Baseline|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30337|NCT02062385|B3|Baseline|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30338|NCT02062385|B2|Baseline|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
30339|NCT02062385|B1|Baseline|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
30340|NCT02062385|P4|Participant Flow|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30341|NCT02062385|P3|Participant Flow|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30342|NCT02062385|P2|Participant Flow|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
30343|NCT02062385|P1|Participant Flow|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
30344|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30345|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30346|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30423|NCT02061358|P2|Participant Flow|10 mg UV-4B|UV-4B 10 mg oral, single dose
30424|NCT02061358|P1|Participant Flow|3 mg UV-4B|UV-4B 3 mg oral, single dose
30425|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30347|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30348|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30349|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30350|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30351|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30352|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30353|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30354|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30355|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30356|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30357|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30358|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30359|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30360|NCT02062385|E2|Reported Event|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30361|NCT02062385|E1|Reported Event|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
30426|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30427|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30362|NCT02062359|B1|Baseline|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30363|NCT02062359|P1|Participant Flow|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30364|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30365|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30366|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30367|NCT02062359|E1|Reported Event|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
30368|NCT02062294|B1|Baseline|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
30369|NCT02062294|P1|Participant Flow|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
30370|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
30371|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
30372|NCT02062294|E1|Reported Event|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
30373|NCT02062177|B3|Baseline|Total|Total of all reporting groups
30374|NCT02062177|B2|Baseline|Midazolam Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
30428|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30429|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30375|NCT02062177|B1|Baseline|Propofol Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.~Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient’s arm covering the i.v. line and TCI pump)."
30376|NCT02062177|P2|Participant Flow|Midazolam Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
30377|NCT02062177|P1|Participant Flow|Propofol Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
30378|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
30379|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
30380|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
30381|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
30382|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
30383|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
30384|NCT02062177|E2|Reported Event|Midazolam Group; n=35, 35|35 upper endoscopy 35 colonoscopy
30385|NCT02062177|E1|Reported Event|Propofol Group; n=35, 35|35 upper endoscopy 35 colonoscopy
30386|NCT02061683|B1|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
30387|NCT02061683|P1|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
30388|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
30389|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
30390|NCT02061683|E1|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
30391|NCT02061592|B3|Baseline|Total|Total of all reporting groups
30392|NCT02061592|B2|Baseline|Test/Control|Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
30393|NCT02061592|B1|Baseline|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
30394|NCT02061592|P2|Participant Flow|Test/Control|Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
30395|NCT02061592|P1|Participant Flow|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
30396|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
30397|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
30398|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
30399|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
30400|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
30401|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
30402|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
30403|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
30404|NCT02061592|E2|Reported Event|Test|Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
30405|NCT02061592|E1|Reported Event|Control|Subjects who received control lens etafilcon A in either the first or the last week of the study .
30406|NCT02061358|B10|Baseline|Total|Total of all reporting groups
30407|NCT02061358|B9|Baseline|Placebo|Placebo oral, single dose
30408|NCT02061358|B8|Baseline|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30409|NCT02061358|B7|Baseline|720 mg UV-4B|UV-4B 720 mg oral, single dose
30410|NCT02061358|B6|Baseline|360 mg UV-4B|UV-4B 360 mg oral, single dose
30411|NCT02061358|B5|Baseline|180 mg UV-4B|UV-4B 180 mg oral, single dose
30412|NCT02061358|B4|Baseline|90 mg UV-4B|UV-4B 90 mg oral, single dose
30413|NCT02061358|B3|Baseline|30 mg UV-4B|UV-4B 30 mg oral, single dose
30414|NCT02061358|B2|Baseline|10 mg UV-4B|UV-4B 10 mg oral, single dose
30415|NCT02061358|B1|Baseline|3 mg UV-4B|UV-4B 3 mg oral, single dose
30416|NCT02061358|P9|Participant Flow|Placebo|Placebo oral, single dose
30417|NCT02061358|P8|Participant Flow|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30418|NCT02061358|P7|Participant Flow|720 mg UV-4B|UV-4B 720 mg oral, single dose
30419|NCT02061358|P6|Participant Flow|360 mg UV-4B|UV-4B 360 mg oral, single dose
30420|NCT02061358|P5|Participant Flow|180 mg UV-4B|UV-4B 180 mg oral, single dose
30421|NCT02061358|P4|Participant Flow|90 mg UV-4B|UV-4B 90 mg oral, single dose
30422|NCT02061358|P3|Participant Flow|30 mg UV-4B|UV-4B 30 mg oral, single dose
30433|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30434|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30435|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30436|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30437|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30438|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30439|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30440|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30441|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30442|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30443|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30444|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30445|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30446|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30447|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30448|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30449|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30450|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30451|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30452|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30453|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30454|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30455|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30456|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30457|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30458|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30459|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30460|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30461|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30462|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30463|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30464|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30465|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30466|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30467|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30468|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30469|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30470|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30471|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30472|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30473|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30474|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30475|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30476|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30477|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30478|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30479|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30480|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30481|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30482|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30483|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30484|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30485|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30486|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30487|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30488|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30489|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30490|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30491|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30492|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30493|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30494|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30495|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30496|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30497|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30498|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30499|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30500|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30501|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30502|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30503|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30504|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30505|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
30506|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30507|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30508|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30509|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30510|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30511|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30512|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30515|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30516|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30517|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30518|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30519|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30520|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30521|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30522|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30523|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
30524|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30525|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30526|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30527|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30528|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30529|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30530|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30531|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30532|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
30533|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30534|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30535|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30536|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30537|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30538|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30539|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30540|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30541|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
30542|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30543|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
30544|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
30545|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
30546|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
30547|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
30548|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
30549|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
30550|NCT02061358|E9|Reported Event|Placebo|Placebo oral, single dose
30551|NCT02061358|E8|Reported Event|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
30552|NCT02061358|E7|Reported Event|720 mg UV-4B|UV-4B 720 mg oral, single dose
30553|NCT02061358|E6|Reported Event|360 mg UV-4B|UV-4B 360 mg oral, single dose
30554|NCT02061358|E5|Reported Event|180 mg UV-4B|UV-4B 180 mg oral, single dose
30555|NCT02061358|E4|Reported Event|90 mg UV-4B|UV-4B 90 mg oral, single dose
30556|NCT02061358|E3|Reported Event|30 mg UV-4B|UV-4B 30 mg oral, single dose
30557|NCT02061358|E2|Reported Event|10 mg UV-4B|UV-4B 10 mg oral, single dose
30558|NCT02061358|E1|Reported Event|3 mg UV-4B|UV-4B 3 mg oral, single dose
30559|NCT02060539|B1|Baseline|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30560|NCT02060539|P1|Participant Flow|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30561|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30562|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30563|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30564|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30565|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30566|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30567|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30568|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30569|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30570|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30571|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30572|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30573|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30574|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30575|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30576|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30577|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30578|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30579|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30580|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30581|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30582|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30583|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30584|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30585|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30586|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30587|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30588|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30589|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30590|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30591|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30592|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30593|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30594|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30595|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30596|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30597|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30598|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30599|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30600|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30601|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30602|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30603|NCT02060539|E1|Reported Event|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
30604|NCT02059993|B3|Baseline|Total|Total of all reporting groups
30605|NCT02059993|B2|Baseline|Control|The control group received the standardized antihypertensive medications but without receiving CPAP machine.
30606|NCT02059993|B1|Baseline|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
30607|NCT02059993|P2|Participant Flow|Control|The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
30608|NCT02059993|P1|Participant Flow|Continuous Positive Airway Pressure(CPAP) Group|The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.
30609|NCT02059993|O2|Outcome|Control|The patients who use standardized drugs without CPAP machine.
30610|NCT02059993|O1|Outcome|Continuous Positive Airway Pressure(CPAP) Group|The subjects who received CPAP treatment and standardized medicine.
30611|NCT02059993|E2|Reported Event|Control|The control subjects received standardised anti-hypertension medications according to the current guildline.
30612|NCT02059993|E1|Reported Event|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
30613|NCT02059070|B3|Baseline|Total|Total of all reporting groups
30614|NCT02059070|B2|Baseline|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30615|NCT02059070|B1|Baseline|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30616|NCT02059070|P2|Participant Flow|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30617|NCT02059070|P1|Participant Flow|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30618|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30619|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30620|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30621|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30622|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30623|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30624|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30625|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30626|NCT02059070|E2|Reported Event|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30627|NCT02059070|E1|Reported Event|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
30628|NCT02058992|B1|Baseline|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30629|NCT02058992|P1|Participant Flow|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30630|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30631|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30632|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30633|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30634|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30635|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30636|NCT02058992|E1|Reported Event|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
30637|NCT02058537|B1|Baseline|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30638|NCT02058537|P1|Participant Flow|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30639|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30640|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30641|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30642|NCT02058537|E1|Reported Event|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
30643|NCT02058498|B1|Baseline|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30644|NCT02058498|P1|Participant Flow|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30693|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30694|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30645|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30646|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30647|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30648|NCT02058498|E1|Reported Event|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
30649|NCT02058290|B3|Baseline|Total|Total of all reporting groups
30650|NCT02058290|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30651|NCT02058290|B1|Baseline|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30652|NCT02058290|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30653|NCT02058290|P1|Participant Flow|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30654|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30655|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30656|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30657|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30658|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30659|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30695|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30696|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30660|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30661|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30662|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30663|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30664|NCT02058290|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
30665|NCT02058290|E1|Reported Event|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
30666|NCT02058160|B3|Baseline|Total|Total of all reporting groups
30667|NCT02058160|B2|Baseline|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30668|NCT02058160|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30669|NCT02058160|P2|Participant Flow|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30670|NCT02058160|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
30671|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30672|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30673|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30674|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30675|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30676|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30677|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30678|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30679|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30680|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30681|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30682|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30683|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30684|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30685|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30686|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30687|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30688|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30689|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30690|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30691|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30692|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30697|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30698|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30699|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30700|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30701|NCT02058160|E2|Reported Event|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
30702|NCT02058160|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
30703|NCT02058147|B4|Baseline|Total|Total of all reporting groups
30704|NCT02058147|B3|Baseline|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30705|NCT02058147|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30706|NCT02058147|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30707|NCT02058147|P3|Participant Flow|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30708|NCT02058147|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30709|NCT02058147|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
30710|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30711|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30712|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30713|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30714|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30715|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30716|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30717|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30718|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30719|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30720|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30721|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30722|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30723|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30724|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30725|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30726|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30727|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30728|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30729|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30730|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30731|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30732|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30733|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30734|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30735|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30736|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30737|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30738|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30739|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30740|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30741|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30742|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30743|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30744|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30745|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30746|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30747|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30748|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30749|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30750|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30751|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
30752|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30753|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
30754|NCT02058147|E3|Reported Event|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose) median exposure: 211 days).
30755|NCT02058147|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
30756|NCT02058147|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
30757|NCT02058069|B1|Baseline|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30758|NCT02058069|P1|Participant Flow|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Participants throughout this posting is equivalent to the number of knees."
30759|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30760|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30761|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30762|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30763|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
30764|NCT02058069|E1|Reported Event|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Note regarding serious AEs:~Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient’s overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device."
30765|NCT02057835|B11|Baseline|Total|Total of all reporting groups
30766|NCT02057835|B10|Baseline|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30767|NCT02057835|B9|Baseline|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30768|NCT02057835|B8|Baseline|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30769|NCT02057835|B7|Baseline|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30770|NCT02057835|B6|Baseline|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30771|NCT02057835|B5|Baseline|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30772|NCT02057835|B4|Baseline|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30773|NCT02057835|B3|Baseline|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30774|NCT02057835|B2|Baseline|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30775|NCT02057835|B1|Baseline|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30776|NCT02057835|P10|Participant Flow|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30777|NCT02057835|P9|Participant Flow|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30778|NCT02057835|P8|Participant Flow|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30779|NCT02057835|P7|Participant Flow|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30780|NCT02057835|P6|Participant Flow|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30781|NCT02057835|P5|Participant Flow|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30782|NCT02057835|P4|Participant Flow|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30783|NCT02057835|P3|Participant Flow|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30784|NCT02057835|P2|Participant Flow|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30785|NCT02057835|P1|Participant Flow|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30786|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30787|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30788|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30789|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30790|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30791|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30792|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30793|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30794|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30795|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30796|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30797|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30798|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30799|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30800|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30801|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30802|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30803|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30804|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30805|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30806|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30807|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30808|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30809|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30810|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30811|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30812|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30813|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30814|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30815|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30816|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30817|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30981|NCT02054754|O1|Outcome|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30818|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30819|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30820|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30821|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30822|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30823|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30824|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30825|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30826|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30827|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30828|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30829|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30830|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30831|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30832|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30833|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30834|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30835|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30836|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30837|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30838|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30839|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30840|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30841|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30842|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30843|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30844|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30845|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30846|NCT02057835|O10|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30847|NCT02057835|O9|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30848|NCT02057835|O8|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30849|NCT02057835|O7|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30850|NCT02057835|O6|Outcome|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30851|NCT02057835|O5|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30852|NCT02057835|O4|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30853|NCT02057835|O3|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30854|NCT02057835|O2|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30982|NCT02054754|E6|Reported Event|Placebo|"Single oral dose of matching placebo~Placebo"
30855|NCT02057835|O1|Outcome|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30856|NCT02057835|E5|Reported Event|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
30857|NCT02057835|E4|Reported Event|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
30858|NCT02057835|E3|Reported Event|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
30859|NCT02057835|E2|Reported Event|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
30860|NCT02057835|E1|Reported Event|Placebo|Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
30861|NCT02057276|B3|Baseline|Total|Total of all reporting groups
30862|NCT02057276|B2|Baseline|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30863|NCT02057276|B1|Baseline|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30864|NCT02057276|P2|Participant Flow|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30865|NCT02057276|P1|Participant Flow|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30866|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30867|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30868|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30869|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30870|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30871|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30872|NCT02057276|E2|Reported Event|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
30873|NCT02057276|E1|Reported Event|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
30874|NCT02057237|B1|Baseline|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
30875|NCT02057237|P1|Participant Flow|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
30876|NCT02057237|O1|Outcome|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
30877|NCT02057237|O1|Outcome|Single Arm|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
30878|NCT02057237|E1|Reported Event|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
30879|NCT02056834|B1|Baseline|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30880|NCT02056834|P1|Participant Flow|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30881|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30882|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30883|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30884|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30885|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30886|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30887|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30888|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30889|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30890|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30891|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30892|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30893|NCT02056834|O1|Outcome|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
30894|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30895|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30896|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
30897|NCT02056834|E1|Reported Event|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
30898|NCT02056392|B7|Baseline|Total|Total of all reporting groups
30899|NCT02056392|B6|Baseline|Selumetinib/Selumetinib Placebo/Moxifloxacin|
30900|NCT02056392|B5|Baseline|Selumetinib Placebo/Selumetinib/Moxifloxacin|
30901|NCT02056392|B4|Baseline|Selumetinib Placebo/Moxifloxacin/Selumetinib|
30902|NCT02056392|B3|Baseline|Moxifloxacin/Selumetinib Placebo/Selumetinib|
30903|NCT02056392|B2|Baseline|Moxifloxacin/Selumetinib/Selumetinib Placebo|
30904|NCT02056392|B1|Baseline|Selumetinib/Moxifloxacin/Selumetinib Placebo|
30905|NCT02056392|P6|Participant Flow|Selumetinib/Selumetinib Placebo/Moxifloxacin|
30906|NCT02056392|P5|Participant Flow|Selumetinib Placebo/Selumetinib/Moxifloxacin|
30907|NCT02056392|P4|Participant Flow|Selumetinib Placebo/Moxifloxacin/Selumetinib|
30908|NCT02056392|P3|Participant Flow|Moxifloxacin/Selumetinib Placebo/Selumetinib|
30909|NCT02056392|P2|Participant Flow|Moxifloxacin/Selumetinib/Selumetinib Placebo|
30910|NCT02056392|P1|Participant Flow|Selumetinib/Moxifloxacin/Selumetinib Placebo|
30911|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30912|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30913|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30914|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30915|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30916|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30917|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30918|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30919|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30920|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30921|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30922|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30923|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30924|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30925|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30926|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30927|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30928|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30929|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30930|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30931|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30932|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30933|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30934|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30935|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30936|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30937|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30938|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30939|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
30940|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
30941|NCT02056392|E3|Reported Event|Placebo|Selumetinib placebo (3 capsules)
30942|NCT02056392|E2|Reported Event|Moxifloxacin|Moxiflxacin 400 mg (open label)
30943|NCT02056392|E1|Reported Event|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
30944|NCT02055430|B3|Baseline|Total|Total of all reporting groups
30983|NCT02054754|E5|Reported Event|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30984|NCT02054754|E4|Reported Event|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30945|NCT02055430|B2|Baseline|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30946|NCT02055430|B1|Baseline|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30947|NCT02055430|P2|Participant Flow|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30948|NCT02055430|P1|Participant Flow|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30949|NCT02055430|O2|Outcome|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30950|NCT02055430|O1|Outcome|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30951|NCT02055430|E2|Reported Event|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30952|NCT02055430|E1|Reported Event|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
30953|NCT02055404|B1|Baseline|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
30954|NCT02055404|P1|Participant Flow|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
30955|NCT02055404|O9|Outcome|Control|Etafilcon A toric contact lens
30956|NCT02055404|O8|Outcome|S8 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30957|NCT02055404|O7|Outcome|S7 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30958|NCT02055404|O6|Outcome|S6 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30959|NCT02055404|O5|Outcome|S5 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30960|NCT02055404|O4|Outcome|S4 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30961|NCT02055404|O3|Outcome|S3 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30962|NCT02055404|O2|Outcome|S2 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30963|NCT02055404|O1|Outcome|S1 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
30964|NCT02055404|E2|Reported Event|Etafilcon A|Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration
30965|NCT02055404|E1|Reported Event|Delefilcon A|Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.
30966|NCT02054754|B3|Baseline|Total|Total of all reporting groups
30967|NCT02054754|B2|Baseline|Placebo|"Single oral dose of matching placebo~Placebo"
30968|NCT02054754|B1|Baseline|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30969|NCT02054754|P6|Participant Flow|Placebo|"Single oral dose of matching placebo~Placebo"
30970|NCT02054754|P5|Participant Flow|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol at Dose level 5~Dexanabinol: Oral formulation of dexanabinol"
30971|NCT02054754|P4|Participant Flow|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol at Dose level 4~Dexanabinol: Oral formulation of dexanabinol"
30972|NCT02054754|P3|Participant Flow|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol at Dose level 3~Dexanabinol: Oral formulation of dexanabinol"
30973|NCT02054754|P2|Participant Flow|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol at Dose level 2~Dexanabinol: Oral formulation of dexanabinol"
30974|NCT02054754|P1|Participant Flow|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol at Dose Level 1~Dexanabinol: Oral formulation of dexanabinol"
30975|NCT02054754|O5|Outcome|Dose Level 5|
30976|NCT02054754|O4|Outcome|Dose Level 4|
30977|NCT02054754|O3|Outcome|Dose Level 3|
30978|NCT02054754|O2|Outcome|Dose Level 2|
30979|NCT02054754|O1|Outcome|Dexanabinol Dose Level 1|
30980|NCT02054754|O2|Outcome|Placebo|"Single oral dose of matching placebo~Placebo"
70818|NCT01746862|B3|Baseline|Total|Total of all reporting groups
30985|NCT02054754|E3|Reported Event|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol~Dexanabinol: Oral formuulation of dexanabinol"
30986|NCT02054754|E2|Reported Event|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30987|NCT02054754|E1|Reported Event|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
30988|NCT02054702|B3|Baseline|Total|Total of all reporting groups
30989|NCT02054702|B2|Baseline|Arpiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
30990|NCT02054702|B1|Baseline|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
30991|NCT02054702|P2|Participant Flow|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
30992|NCT02054702|P1|Participant Flow|Brexpiprazole|Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
30993|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
30994|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
30995|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
30996|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
30997|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
30998|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
30999|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31000|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31001|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31002|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31003|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31004|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31005|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31006|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31007|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31008|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31009|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31010|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31011|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31012|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31013|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31014|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31349|NCT02048891|O2|Outcome|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
31015|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31016|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31017|NCT02054702|E2|Reported Event|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
31018|NCT02054702|E1|Reported Event|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
31019|NCT02054481|B5|Baseline|Total|Total of all reporting groups
31020|NCT02054481|B4|Baseline|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31021|NCT02054481|B3|Baseline|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31022|NCT02054481|B2|Baseline|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31023|NCT02054481|B1|Baseline|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31024|NCT02054481|P4|Participant Flow|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31025|NCT02054481|P3|Participant Flow|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31026|NCT02054481|P2|Participant Flow|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31027|NCT02054481|P1|Participant Flow|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31028|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31029|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31030|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31031|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31032|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31033|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31034|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31035|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31036|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31037|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31038|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31039|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31040|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31041|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31042|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31071|NCT02054481|E1|Reported Event|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31043|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31044|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31045|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31046|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31047|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31048|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31049|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31050|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31051|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31052|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31053|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31054|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31055|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31056|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31057|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31058|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31059|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31060|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31061|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31062|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31063|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31064|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
31065|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31066|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31067|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
31068|NCT02054481|E4|Reported Event|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
31069|NCT02054481|E3|Reported Event|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
31070|NCT02054481|E2|Reported Event|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
31072|NCT02054325|B3|Baseline|Total|Total of all reporting groups
33696|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
31073|NCT02054325|B2|Baseline|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31074|NCT02054325|B1|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31075|NCT02054325|P2|Participant Flow|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31076|NCT02054325|P1|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31077|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31078|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31079|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31080|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31081|NCT02054325|E2|Reported Event|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31082|NCT02054325|E1|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
31083|NCT02053610|B3|Baseline|Total|Total of all reporting groups
31084|NCT02053610|B2|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31085|NCT02053610|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31086|NCT02053610|P2|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31087|NCT02053610|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31088|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31089|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31090|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31091|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31092|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31093|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31094|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31095|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31096|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31097|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31098|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31099|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31100|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31101|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31102|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31103|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31104|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31105|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31106|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31107|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31108|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31109|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31110|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31111|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31112|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31113|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31114|NCT02053610|E2|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
31115|NCT02053610|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
31116|NCT02053493|B3|Baseline|Total|Total of all reporting groups
31117|NCT02053493|B2|Baseline|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31118|NCT02053493|B1|Baseline|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31119|NCT02053493|P2|Participant Flow|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31120|NCT02053493|P1|Participant Flow|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31121|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31122|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31123|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31124|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31125|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31126|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31127|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31128|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31129|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31130|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31131|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31177|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
33697|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
31132|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31133|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31134|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31135|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31136|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31137|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31138|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31139|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31140|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31141|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31142|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31143|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31144|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31145|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31146|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31147|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31178|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31443|NCT02045732|B1|Baseline|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31148|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31149|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31150|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31151|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31152|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31153|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31154|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31155|NCT02053493|E2|Reported Event|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
31156|NCT02053493|E1|Reported Event|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
31157|NCT02052895|B4|Baseline|Total|Total of all reporting groups
31158|NCT02052895|B3|Baseline|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
31159|NCT02052895|B2|Baseline|Control|Patients without SIRS, sepsis, or end stage renal disease
31160|NCT02052895|B1|Baseline|Sepsis/SIRS|Patients with sepsis or SIRS
31161|NCT02052895|P3|Participant Flow|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
31162|NCT02052895|P2|Participant Flow|Control|Patients without SIRS, sepsis, or end stage renal disease
31163|NCT02052895|P1|Participant Flow|Sepsis/SIRS|Patients with sepsis or SIRS
31164|NCT02052895|O2|Outcome|Procalcitonin|ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
31165|NCT02052895|O1|Outcome|Presepsin|ROC-AUC of presepsin for discriminating between Sepsis and SIRS
31166|NCT02052895|E3|Reported Event|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
31167|NCT02052895|E2|Reported Event|Control|Patients without SIRS, sepsis, or end stage renal disease
31168|NCT02052895|E1|Reported Event|Sepsis/SIRS|Patients with sepsis or SIRS
31169|NCT02052752|B4|Baseline|Total|Total of all reporting groups
31170|NCT02052752|B3|Baseline|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31171|NCT02052752|B2|Baseline|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31172|NCT02052752|B1|Baseline|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31173|NCT02052752|P3|Participant Flow|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31174|NCT02052752|P2|Participant Flow|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31175|NCT02052752|P1|Participant Flow|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31176|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31254|NCT02051335|B5|Baseline|Total|Total of all reporting groups
33698|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
31179|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3
31180|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31181|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31182|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31183|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31184|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31185|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31186|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31187|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31188|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31189|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31190|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31191|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31192|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31193|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31194|NCT02052752|E3|Reported Event|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31195|NCT02052752|E2|Reported Event|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31196|NCT02052752|E1|Reported Event|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
31197|NCT02052661|B1|Baseline|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31198|NCT02052661|P1|Participant Flow|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31199|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31200|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31201|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31202|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31203|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31204|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31267|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31205|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31206|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31207|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31208|NCT02052661|E1|Reported Event|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
31209|NCT02052635|B3|Baseline|Total|Total of all reporting groups
31210|NCT02052635|B2|Baseline|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
31211|NCT02052635|B1|Baseline|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
31212|NCT02052635|P2|Participant Flow|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
31213|NCT02052635|P1|Participant Flow|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
31214|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
31215|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
31216|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
31217|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
31218|NCT02052635|E2|Reported Event|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
31219|NCT02052635|E1|Reported Event|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
31220|NCT02052544|B1|Baseline|Plasma Samples From Subjects Receiving Unfractionated Heparin|A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
31221|NCT02052544|P1|Participant Flow|Study Patients|Patients receiving unfractionated heparin (UFH)
31222|NCT02052544|O2|Outcome|Hemosil|Sensitivity and Specificity of Hemosil
31223|NCT02052544|O1|Outcome|Pefakit|Sensitivity and Specificity of Pefakit
31224|NCT02052544|E1|Reported Event|Study Patients|Patients receiving unfractionated heparin (UFH)
31225|NCT02052414|B1|Baseline|Gralise (Gabapentin ER)|"This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.~Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.~Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.~At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded."
31226|NCT02052414|P1|Participant Flow|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31227|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31268|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31269|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31228|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31229|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|All subjects were assessed for occurrence of adverse events at follow up visits. All reported adverse events were tabulated, and presented in this study.
31230|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31231|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31232|NCT02052414|E1|Reported Event|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
31233|NCT02051790|B1|Baseline|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
31234|NCT02051790|P1|Participant Flow|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
31235|NCT02051790|O1|Outcome|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
31236|NCT02051790|E1|Reported Event|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
31237|NCT02051595|B1|Baseline|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
31238|NCT02051595|P1|Participant Flow|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
31239|NCT02051595|O1|Outcome|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
31240|NCT02051595|E1|Reported Event|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
31241|NCT02051426|B3|Baseline|Total|Total of all reporting groups
31242|NCT02051426|B2|Baseline|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
31243|NCT02051426|B1|Baseline|D-serine First, Then Placebo|D-serine (2.1g), then placebo (corn starch)
31244|NCT02051426|P2|Participant Flow|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
31245|NCT02051426|P1|Participant Flow|D-serine First, Then Placebo|D-serine (2.1g), then Placebo (corn starch)
31246|NCT02051426|O2|Outcome|Placebo|corn starch
31247|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
31248|NCT02051426|O2|Outcome|Placebo|corn starch
31249|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
31250|NCT02051426|O2|Outcome|Placebo|corn starch
31251|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
31252|NCT02051426|E2|Reported Event|Placebo|corn starch
31253|NCT02051426|E1|Reported Event|D-serine|D-serine (2.1g)
31255|NCT02051335|B4|Baseline|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31256|NCT02051335|B3|Baseline|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31257|NCT02051335|B2|Baseline|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31258|NCT02051335|B1|Baseline|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31259|NCT02051335|P4|Participant Flow|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31260|NCT02051335|P3|Participant Flow|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31261|NCT02051335|P2|Participant Flow|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31262|NCT02051335|P1|Participant Flow|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
31263|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31264|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31265|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31266|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31347|NCT02048891|P2|Participant Flow|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
31270|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31271|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31272|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31273|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31274|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31275|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31276|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31277|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31278|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31279|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31280|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31281|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31282|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31283|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31284|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31285|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31286|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31287|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31288|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31289|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31290|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31291|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31292|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31293|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31294|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31295|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31296|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31297|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31298|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
72794|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
31299|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31300|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31301|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31302|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31303|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31304|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31305|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31306|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31307|NCT02051335|E4|Reported Event|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31308|NCT02051335|E3|Reported Event|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31309|NCT02051335|E2|Reported Event|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31310|NCT02051335|E1|Reported Event|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
31311|NCT02050334|B3|Baseline|Total|Total of all reporting groups
31312|NCT02050334|B2|Baseline|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
31313|NCT02050334|B1|Baseline|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
31314|NCT02050334|P2|Participant Flow|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
31315|NCT02050334|P1|Participant Flow|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
31316|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
31317|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
31318|NCT02050334|O2|Outcome|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
31319|NCT02050334|O1|Outcome|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
31320|NCT02050334|E2|Reported Event|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
31321|NCT02050334|E1|Reported Event|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
31322|NCT02050048|B3|Baseline|Total|Total of all reporting groups
31323|NCT02050048|B2|Baseline|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
31324|NCT02050048|B1|Baseline|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
31325|NCT02050048|P2|Participant Flow|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
31326|NCT02050048|P1|Participant Flow|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
31348|NCT02048891|P1|Participant Flow|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
33081|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
31327|NCT02050048|O2|Outcome|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
31328|NCT02050048|O1|Outcome|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
31329|NCT02050048|E2|Reported Event|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
31330|NCT02050048|E1|Reported Event|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
31331|NCT02049931|B4|Baseline|Total|Total of all reporting groups
31332|NCT02049931|B3|Baseline|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
31333|NCT02049931|B2|Baseline|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
31334|NCT02049931|B1|Baseline|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
31335|NCT02049931|P3|Participant Flow|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
31336|NCT02049931|P2|Participant Flow|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
31337|NCT02049931|P1|Participant Flow|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
31338|NCT02049931|O3|Outcome|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
31339|NCT02049931|O2|Outcome|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
31340|NCT02049931|O1|Outcome|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
31341|NCT02049931|E3|Reported Event|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
31342|NCT02049931|E2|Reported Event|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
31343|NCT02049931|E1|Reported Event|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
31344|NCT02048891|B3|Baseline|Total|Total of all reporting groups
31345|NCT02048891|B2|Baseline|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
31346|NCT02048891|B1|Baseline|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
72795|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
31350|NCT02048891|O1|Outcome|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
31351|NCT02048891|E2|Reported Event|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
31352|NCT02048891|E1|Reported Event|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
31353|NCT02048072|B1|Baseline|Gilenya|Gilenya 0.5mg p.o. once daily
31354|NCT02048072|P1|Participant Flow|Gilenya|Gilenya 0.5mg p.o. once daily
31355|NCT02048072|O1|Outcome|Gilenya|Gilenya 0.5mg p.o. once daily
31356|NCT02048072|E1|Reported Event|Gilenya|Gilenya 0.5mg p.o. once daily
31357|NCT02047747|B1|Baseline|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
31358|NCT02047747|P1|Participant Flow|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
31359|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
31360|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
31361|NCT02047747|E1|Reported Event|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
31362|NCT02047227|B3|Baseline|Total|Total of all reporting groups
31363|NCT02047227|B2|Baseline|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31364|NCT02047227|B1|Baseline|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31365|NCT02047227|P2|Participant Flow|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31366|NCT02047227|P1|Participant Flow|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31367|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31368|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31369|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31370|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31371|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31444|NCT02045732|P2|Participant Flow|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.
31372|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31373|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31374|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31375|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31376|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31377|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31378|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31379|NCT02047227|E2|Reported Event|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
31380|NCT02047227|E1|Reported Event|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
31381|NCT02046993|B3|Baseline|Total|Total of all reporting groups
31382|NCT02046993|B2|Baseline|Hypertensive Patients on Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31383|NCT02046993|B1|Baseline|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31384|NCT02046993|P2|Participant Flow|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31385|NCT02046993|P1|Participant Flow|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31386|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31387|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31418|NCT02046772|B2|Baseline|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31388|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31389|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31390|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31391|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31392|NCT02046993|O2|Outcome|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31393|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31394|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31395|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31396|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
31397|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
31398|NCT02046993|E2|Reported Event|Enhanced Usual Care|". Patients to do HBP measurement~. Record BP readings in their diary~Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary"
31399|NCT02046993|E1|Reported Event|Smart Phone Based Telemonitoring of HBP|". Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary"
31400|NCT02046980|B4|Baseline|Total|Total of all reporting groups
31401|NCT02046980|B3|Baseline|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
31402|NCT02046980|B2|Baseline|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
31403|NCT02046980|B1|Baseline|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
31404|NCT02046980|P3|Participant Flow|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
31405|NCT02046980|P2|Participant Flow|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
31406|NCT02046980|P1|Participant Flow|Gufoni|"Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day~Gufoni"
31407|NCT02046980|O3|Outcome|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
31408|NCT02046980|O2|Outcome|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
31409|NCT02046980|O1|Outcome|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
31410|NCT02046980|E3|Reported Event|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
31411|NCT02046980|E2|Reported Event|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
31412|NCT02046980|E1|Reported Event|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
31413|NCT02046863|B1|Baseline|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
31414|NCT02046863|P1|Participant Flow|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
31415|NCT02046863|O1|Outcome|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
31416|NCT02046863|E1|Reported Event|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
31417|NCT02046772|B3|Baseline|Total|Total of all reporting groups
72796|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
31419|NCT02046772|B1|Baseline|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31420|NCT02046772|P2|Participant Flow|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31421|NCT02046772|P1|Participant Flow|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31422|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31423|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31424|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31425|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31426|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31427|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31428|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31429|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31430|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31431|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31432|NCT02046772|E2|Reported Event|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
31433|NCT02046772|E1|Reported Event|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
31434|NCT02046226|B1|Baseline|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
31435|NCT02046226|P1|Participant Flow|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
31436|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
31437|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
31438|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
31439|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
31440|NCT02046226|E1|Reported Event|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated on each case report form.
31441|NCT02045732|B3|Baseline|Total|Total of all reporting groups
31442|NCT02045732|B2|Baseline|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31445|NCT02045732|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.
31446|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31447|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31448|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31449|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31450|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31451|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31452|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31453|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31454|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31455|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31456|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31457|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31458|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31459|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31460|NCT02045732|E2|Reported Event|PF-06342674|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
31461|NCT02045732|E1|Reported Event|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
31462|NCT02045264|B1|Baseline|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31463|NCT02045264|P1|Participant Flow|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31464|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31465|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31466|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31467|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31468|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31469|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31470|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31471|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31472|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31473|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31474|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31475|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31476|NCT02045264|E1|Reported Event|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
31477|NCT02045238|B3|Baseline|Total|Total of all reporting groups
31478|NCT02045238|B2|Baseline|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31479|NCT02045238|B1|Baseline|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31480|NCT02045238|P2|Participant Flow|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
33699|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
31481|NCT02045238|P1|Participant Flow|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31482|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31483|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31484|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31485|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31486|NCT02045238|E2|Reported Event|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31487|NCT02045238|E1|Reported Event|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
31488|NCT02044848|B3|Baseline|Total|Total of all reporting groups
31489|NCT02044848|B2|Baseline|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31490|NCT02044848|B1|Baseline|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31491|NCT02044848|P2|Participant Flow|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31492|NCT02044848|P1|Participant Flow|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31493|NCT02044848|O2|Outcome|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31494|NCT02044848|O1|Outcome|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31495|NCT02044848|E2|Reported Event|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31496|NCT02044848|E1|Reported Event|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
31497|NCT02044458|B3|Baseline|Total|Total of all reporting groups
31498|NCT02044458|B2|Baseline|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31499|NCT02044458|B1|Baseline|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31500|NCT02044458|P2|Participant Flow|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31501|NCT02044458|P1|Participant Flow|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31502|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31503|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31504|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31631|NCT02043366|E6|Reported Event|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
31505|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31506|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31507|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31508|NCT02044458|E2|Reported Event|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
31509|NCT02044458|E1|Reported Event|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
31510|NCT02044393|B3|Baseline|Total|Total of all reporting groups
31511|NCT02044393|B2|Baseline|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
31512|NCT02044393|B1|Baseline|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
31513|NCT02044393|P2|Participant Flow|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
31514|NCT02044393|P1|Participant Flow|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
31515|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
31516|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
31517|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
31518|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
31519|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
31520|NCT02044393|O1|Outcome|BI 691751|"single dose BI 691751~BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal."
31521|NCT02044393|E5|Reported Event|Total on Treatment|combination of BI 691751, loading IT and BI 691751+ further IT.
31522|NCT02044393|E4|Reported Event|Total BI 691751|total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751)
31523|NCT02044393|E3|Reported Event|BI 691751 + Further IT|10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days).
31524|NCT02044393|E2|Reported Event|Loading Itraconazole (IT)|200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period).
31525|NCT02044393|E1|Reported Event|BI 691751|10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period)
31526|NCT02044367|B1|Baseline|Overall|A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
31527|NCT02044367|P6|Participant Flow|R-T2-T1|R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31528|NCT02044367|P5|Participant Flow|R-T1-T2|R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
72797|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
31529|NCT02044367|P4|Participant Flow|T2-R-T1|T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31530|NCT02044367|P3|Participant Flow|T2-T1-R|T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31531|NCT02044367|P2|Participant Flow|T1-R-T2|T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31532|NCT02044367|P1|Participant Flow|T1-T2-R|T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31533|NCT02044367|O2|Outcome|T2 (Treatment B)|"T2: Granules resolved in reconstitution solution~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
31534|NCT02044367|O1|Outcome|T1 (Treatment A)|"T1: Pellets on food~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
31535|NCT02044367|O2|Outcome|T2 (Treatment B)|T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
31536|NCT02044367|O1|Outcome|T1 (Treatment A)|T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
31537|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31538|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31539|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31540|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31541|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31542|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31543|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31544|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31545|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31546|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31547|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31548|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
31549|NCT02044367|E3|Reported Event|R (Reference)|multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31550|NCT02044367|E2|Reported Event|T2 (Treatment B)|multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31551|NCT02044367|E1|Reported Event|T1 (Treatment A)|multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
31552|NCT02043808|B3|Baseline|Total|Total of all reporting groups
31553|NCT02043808|B2|Baseline|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31554|NCT02043808|B1|Baseline|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31555|NCT02043808|P2|Participant Flow|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31556|NCT02043808|P1|Participant Flow|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31557|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31558|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31559|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31560|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31561|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31562|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31563|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31564|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31565|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31566|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31567|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31568|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31569|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31570|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31571|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31572|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31573|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31574|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31575|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31576|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31577|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31578|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31579|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31580|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31581|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31582|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31583|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31584|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31585|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31586|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31587|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31588|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31589|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31590|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31591|NCT02043808|E2|Reported Event|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
31592|NCT02043808|E1|Reported Event|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
31593|NCT02043782|B1|Baseline|All Subjects|Pooled data from all arms.
31594|NCT02043782|P6|Participant Flow|Test - Own - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Own product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31595|NCT02043782|P5|Participant Flow|Own - Competitor - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Competitor soft convex product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31596|NCT02043782|P4|Participant Flow|Competitor - Test - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Coloplast test product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31597|NCT02043782|P3|Participant Flow|Own - Test - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Coloplast test product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31629|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31630|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
31598|NCT02043782|P2|Participant Flow|Competitor - Own - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Own product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31599|NCT02043782|P1|Participant Flow|Test - Competitor - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Competitor soft convex product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
31600|NCT02043782|O3|Outcome|Competitor Soft Convex|Subjects testing Competitor Soft Convex
31601|NCT02043782|O2|Outcome|Own Product|Subjects testing own product
31602|NCT02043782|O1|Outcome|Coloplast Test Product|Subjects testing Coloplast test product
31603|NCT02043782|E3|Reported Event|Competitor Soft Convex|Adverse events reported by subjects testing Competitor soft convex
31604|NCT02043782|E2|Reported Event|Own Product|Adverse events reported by subjects testing own product
31605|NCT02043782|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
31606|NCT02043366|B7|Baseline|Total|Total of all reporting groups
31607|NCT02043366|B6|Baseline|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
31608|NCT02043366|B5|Baseline|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
31609|NCT02043366|B4|Baseline|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
31610|NCT02043366|B3|Baseline|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31611|NCT02043366|B2|Baseline|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31612|NCT02043366|B1|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
31613|NCT02043366|P6|Participant Flow|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
31614|NCT02043366|P5|Participant Flow|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
31615|NCT02043366|P4|Participant Flow|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
31616|NCT02043366|P3|Participant Flow|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31617|NCT02043366|P2|Participant Flow|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31618|NCT02043366|P1|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
31619|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
31620|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
31621|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
31622|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31623|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31624|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
31625|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
31626|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
31627|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
31628|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31632|NCT02043366|E5|Reported Event|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani
31633|NCT02043366|E4|Reported Event|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani
31634|NCT02043366|E3|Reported Event|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31635|NCT02043366|E2|Reported Event|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
31636|NCT02043366|E1|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
31637|NCT02043145|B4|Baseline|Total|Total of all reporting groups
31638|NCT02043145|B3|Baseline|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31639|NCT02043145|B2|Baseline|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31640|NCT02043145|B1|Baseline|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31641|NCT02043145|P3|Participant Flow|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31642|NCT02043145|P2|Participant Flow|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31643|NCT02043145|P1|Participant Flow|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31644|NCT02043145|O1|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31645|NCT02043145|O1|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31646|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31647|NCT02043145|O3|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31648|NCT02043145|O2|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31649|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31650|NCT02043145|E3|Reported Event|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31651|NCT02043145|E2|Reported Event|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31652|NCT02043145|E1|Reported Event|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
31653|NCT02042911|B1|Baseline|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31654|NCT02042911|P1|Participant Flow|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31655|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31656|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31657|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31658|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31659|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31660|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31661|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31662|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31663|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31664|NCT02042911|E1|Reported Event|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
31665|NCT02042872|B3|Baseline|Total|Total of all reporting groups
31666|NCT02042872|B2|Baseline|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
31667|NCT02042872|B1|Baseline|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
31668|NCT02042872|P2|Participant Flow|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
31669|NCT02042872|P1|Participant Flow|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
31670|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
31671|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
31672|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
31673|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
31674|NCT02042872|E2|Reported Event|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
31675|NCT02042872|E1|Reported Event|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
31676|NCT02042534|B3|Baseline|Total|Total of all reporting groups
31677|NCT02042534|B2|Baseline|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31678|NCT02042534|B1|Baseline|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31679|NCT02042534|P2|Participant Flow|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31709|NCT02041520|P1|Participant Flow|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31680|NCT02042534|P1|Participant Flow|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31681|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31682|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31683|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31684|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31685|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31686|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31687|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31688|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31689|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31690|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31691|NCT02042534|E2|Reported Event|Warfarin|"Safety population : 90 (patients)~Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
31750|NCT02041325|E1|Reported Event|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
31692|NCT02042534|E1|Reported Event|Rivaroxaban|"Safety population : 98 (patients)~Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
31693|NCT02042404|B1|Baseline|Mild to Severe Hearing Impairment|Subjects wearing the Earlens System in their daily lives.
31694|NCT02042404|P2|Participant Flow|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
31695|NCT02042404|P1|Participant Flow|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
31696|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
31697|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
31698|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
31699|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
31700|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
31701|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
31702|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
31703|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
31704|NCT02042404|E1|Reported Event|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
31705|NCT02041520|B3|Baseline|Total|Total of all reporting groups
31706|NCT02041520|B2|Baseline|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31707|NCT02041520|B1|Baseline|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31708|NCT02041520|P2|Participant Flow|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31747|NCT02041325|O2|Outcome|Placebo|"Placebo will be administered for 7 days prior to and 7 days after the vaccine.~Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine."
31710|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31711|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31712|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31713|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31714|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31715|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31716|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31717|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31718|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31719|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31720|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31721|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31722|NCT02041520|O2|Outcome|Placebo|Patiemts who received placebo for 6 months
31723|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...
31724|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31725|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31726|NCT02041520|E2|Reported Event|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31727|NCT02041520|E1|Reported Event|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
31728|NCT02041377|B1|Baseline|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31748|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks."
31749|NCT02041325|E2|Reported Event|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
31729|NCT02041377|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31730|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31731|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31732|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31733|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31734|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
31735|NCT02041377|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
31736|NCT02041325|B3|Baseline|Total|Total of all reporting groups
31737|NCT02041325|B2|Baseline|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
31738|NCT02041325|B1|Baseline|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
31739|NCT02041325|P2|Participant Flow|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
31740|NCT02041325|P1|Participant Flow|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
31741|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
31742|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
31743|NCT02041325|O2|Outcome|Placebo|"Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.~Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine."
31744|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine."
31745|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
31746|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
33700|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
31751|NCT02041286|B1|Baseline|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
31752|NCT02041286|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
31753|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
31754|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
31755|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
31756|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
31757|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
31758|NCT02041286|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
31759|NCT02041221|B7|Baseline|Total|Total of all reporting groups
31760|NCT02041221|B6|Baseline|Placebo|
31761|NCT02041221|B5|Baseline|S0597 Dose 5|
31762|NCT02041221|B4|Baseline|S0597 Dose 4|
31763|NCT02041221|B3|Baseline|S0597 Dose 3|
31764|NCT02041221|B2|Baseline|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
31765|NCT02041221|B1|Baseline|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
31766|NCT02041221|P6|Participant Flow|Placebo|Subjects will receive placebo
31767|NCT02041221|P5|Participant Flow|S0597 Dose 5|Subjects will receive SPARC1316 dose 5
31768|NCT02041221|P4|Participant Flow|S0597 Dose 4|Subjects will receive SPARC1316 dose 4
31769|NCT02041221|P3|Participant Flow|S0597 Dose 3|Subjects will receive SPARC1316 dose 3
31770|NCT02041221|P2|Participant Flow|S0597 Dose 2|Subjects will receive SPARC1316 dose 2
31771|NCT02041221|P1|Participant Flow|S0597 Dose 1|Subjects will be administered with SPARC1316 dose 1
31772|NCT02041221|O6|Outcome|Placebo|
31773|NCT02041221|O5|Outcome|S0597 Dose 5|
31774|NCT02041221|O4|Outcome|S0597 Dose 4|
31775|NCT02041221|O3|Outcome|S0597 Dose 3|
31776|NCT02041221|O2|Outcome|S0597 Dose 2|
31777|NCT02041221|O1|Outcome|S0597 Dose 1|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
31778|NCT02041221|E6|Reported Event|Placebo|
31779|NCT02041221|E5|Reported Event|S0597 Dose 5|
31780|NCT02041221|E4|Reported Event|S0597 Dose 4|
31781|NCT02041221|E3|Reported Event|S0597 Dose 3|
31782|NCT02041221|E2|Reported Event|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
31783|NCT02041221|E1|Reported Event|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
31784|NCT02040792|B6|Baseline|Total|Total of all reporting groups
31785|NCT02040792|B5|Baseline|350 mcg|"TD-4208~TD-4208"
31786|NCT02040792|B4|Baseline|175 mcg|"TD-4208~TD-4208"
31787|NCT02040792|B3|Baseline|88 mcg|"TD-4208~TD-4208"
31788|NCT02040792|B2|Baseline|44 mcg|"TD-4208~TD-4208"
31789|NCT02040792|B1|Baseline|Placebo|"Placebo~Placebo"
31790|NCT02040792|P5|Participant Flow|350 mcg|"TD-4208~TD-4208"
31791|NCT02040792|P4|Participant Flow|175 mcg|"TD-4208~TD-4208"
31792|NCT02040792|P3|Participant Flow|88 mcg|"TD-4208~TD-4208"
31793|NCT02040792|P2|Participant Flow|44 mcg|"TD-4208~TD-4208"
31794|NCT02040792|P1|Participant Flow|Placebo|"Placebo~Placebo"
31795|NCT02040792|O5|Outcome|350 mcg|"TD-4208~TD-4208"
31796|NCT02040792|O4|Outcome|175 mcg|"TD-4208~TD-4208"
31797|NCT02040792|O3|Outcome|88 mcg|"TD-4208~TD-4208"
31798|NCT02040792|O2|Outcome|44 mcg|"TD-4208~TD-4208"
31799|NCT02040792|O1|Outcome|Placebo|"Placebo~Placebo"
31800|NCT02040792|E5|Reported Event|350 mcg|"TD-4208~TD-4208"
31801|NCT02040792|E4|Reported Event|175 mcg|"TD-4208~TD-4208"
31802|NCT02040792|E3|Reported Event|88 mcg|"TD-4208~TD-4208"
31803|NCT02040792|E2|Reported Event|44 mcg|"TD-4208~TD-4208"
31804|NCT02040792|E1|Reported Event|Placebo|"Placebo~Placebo"
31805|NCT02040623|B4|Baseline|Total|Total of all reporting groups
31806|NCT02040623|B3|Baseline|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
31807|NCT02040623|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
31847|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31808|NCT02040623|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
31809|NCT02040623|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
31810|NCT02040623|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
31811|NCT02040623|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
31812|NCT02040623|O3|Outcome|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
31813|NCT02040623|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
31814|NCT02040623|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
31815|NCT02040623|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
31816|NCT02040623|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
31817|NCT02040623|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
31818|NCT02039817|B3|Baseline|Total|Total of all reporting groups
31819|NCT02039817|B2|Baseline|Severe Renal Impairment|Severe Renal Impairment subjects received one 50mg dose of IDN-6556
31820|NCT02039817|B1|Baseline|Healthy Volunteers|Health Volunteers received one 50mg dose of IDN-6556
31821|NCT02039817|P2|Participant Flow|Severe Renal Impairment|Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
31822|NCT02039817|P1|Participant Flow|Healthy Volumteers|Healthy volunteers were given a single 50mg dose of IDN-6556
31823|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
31824|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
31825|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
31826|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
31827|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
31828|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
31829|NCT02039817|E1|Reported Event|IDN-6556|A single 50mg dose of IDN-6556
31830|NCT02039687|B5|Baseline|Total|Total of all reporting groups
31831|NCT02039687|B4|Baseline|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31832|NCT02039687|B3|Baseline|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31833|NCT02039687|B2|Baseline|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31834|NCT02039687|B1|Baseline|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31835|NCT02039687|P4|Participant Flow|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31836|NCT02039687|P3|Participant Flow|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31837|NCT02039687|P2|Participant Flow|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31838|NCT02039687|P1|Participant Flow|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31839|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31840|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31841|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31842|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31843|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31844|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31845|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31846|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31848|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31849|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31850|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31851|NCT02039687|E4|Reported Event|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
31852|NCT02039687|E3|Reported Event|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31853|NCT02039687|E2|Reported Event|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31854|NCT02039687|E1|Reported Event|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
31855|NCT02039414|B3|Baseline|Total|Total of all reporting groups
31856|NCT02039414|B2|Baseline|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31857|NCT02039414|B1|Baseline|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31858|NCT02039414|P2|Participant Flow|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31859|NCT02039414|P1|Participant Flow|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31860|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31861|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31862|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31863|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31864|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31865|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31866|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31867|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31868|NCT02039414|E2|Reported Event|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
31869|NCT02039414|E1|Reported Event|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
31870|NCT02038959|B3|Baseline|Total|Total of all reporting groups
31871|NCT02038959|B2|Baseline|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31872|NCT02038959|B1|Baseline|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31873|NCT02038959|P2|Participant Flow|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31874|NCT02038959|P1|Participant Flow|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31875|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31876|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31877|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31878|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31879|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31880|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31881|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31882|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31883|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31884|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31885|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31920|NCT02038907|P8|Participant Flow|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31886|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31887|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31888|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31889|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31890|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31891|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31892|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31893|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31894|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31895|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31921|NCT02038907|P7|Participant Flow|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31896|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31897|NCT02038959|E2|Reported Event|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
31898|NCT02038959|E1|Reported Event|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
31899|NCT02038907|B15|Baseline|Total|Total of all reporting groups
31900|NCT02038907|B14|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31901|NCT02038907|B13|Baseline|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31902|NCT02038907|B12|Baseline|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31903|NCT02038907|B11|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31904|NCT02038907|B10|Baseline|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31905|NCT02038907|B9|Baseline|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31906|NCT02038907|B8|Baseline|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31907|NCT02038907|B7|Baseline|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31908|NCT02038907|B6|Baseline|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31909|NCT02038907|B5|Baseline|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31910|NCT02038907|B4|Baseline|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31911|NCT02038907|B3|Baseline|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31912|NCT02038907|B2|Baseline|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31913|NCT02038907|B1|Baseline|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
31914|NCT02038907|P14|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31915|NCT02038907|P13|Participant Flow|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31916|NCT02038907|P12|Participant Flow|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31917|NCT02038907|P11|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31918|NCT02038907|P10|Participant Flow|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31919|NCT02038907|P9|Participant Flow|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31922|NCT02038907|P6|Participant Flow|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31923|NCT02038907|P5|Participant Flow|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31924|NCT02038907|P4|Participant Flow|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31925|NCT02038907|P3|Participant Flow|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31926|NCT02038907|P2|Participant Flow|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31927|NCT02038907|P1|Participant Flow|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
31928|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31929|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31930|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31931|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31932|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31933|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31934|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31935|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31936|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31937|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31938|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31939|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31940|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31941|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
31942|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31943|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31944|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31945|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31946|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31947|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31948|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32487|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
31949|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31950|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31951|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31952|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31953|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31954|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31955|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
31956|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31957|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31958|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31959|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31960|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31961|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31962|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31963|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31964|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31965|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31966|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31967|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31968|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31969|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31970|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31971|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31972|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31973|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31974|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31975|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
72798|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
31976|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31977|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31978|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31979|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31980|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31981|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31982|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31983|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31984|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31985|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31986|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31987|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31988|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
31989|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
31990|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31991|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
31992|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31993|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31994|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
31995|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
31996|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31997|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31998|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
31999|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32000|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32001|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32002|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32003|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32004|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32005|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32006|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32007|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32008|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32009|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32010|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32011|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32012|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32013|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32014|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32015|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32016|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32017|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32018|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32019|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32020|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32021|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32022|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32023|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32024|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32025|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32026|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32027|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32028|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32029|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32030|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32488|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32031|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32032|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32033|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32034|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32035|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32036|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32037|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32038|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32039|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32040|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32041|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32042|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32043|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32044|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32045|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32046|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32047|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32048|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32049|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32050|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32051|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32052|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32053|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32054|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32055|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32056|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32057|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32489|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
72799|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
32058|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32059|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32060|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32061|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32062|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32063|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32064|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32065|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32066|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32067|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32068|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32069|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32070|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32071|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32072|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32073|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32074|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32075|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32076|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32077|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32078|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32079|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32080|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32081|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32082|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32083|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32084|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32490|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32085|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32086|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32087|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32088|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32089|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32090|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32091|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32092|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32093|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32094|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32095|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32096|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32097|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32098|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32099|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32100|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32101|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32102|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32103|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32104|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32105|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32106|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32107|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32108|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32109|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32110|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32111|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32491|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
72800|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
32112|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32113|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32114|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32115|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32116|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32117|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32118|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32119|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32120|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32121|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32122|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32123|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32124|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32125|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32126|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32127|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32128|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32129|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32130|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32131|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32132|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32133|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32134|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32135|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32136|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32137|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32138|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32492|NCT02037477|E4|Reported Event|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32139|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32140|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32141|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32142|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32143|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32144|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32145|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32146|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32147|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32148|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32149|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32150|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32151|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32152|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32153|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32154|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32155|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32156|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32157|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32158|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32159|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32160|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32161|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32162|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32163|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32164|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32165|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32493|NCT02037477|E3|Reported Event|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32166|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32167|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32168|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32169|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32170|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32171|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32172|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32173|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32174|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32175|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32176|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32177|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32178|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32179|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32180|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32181|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32182|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32183|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32184|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32185|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32186|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32187|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32188|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32189|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32190|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32191|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32192|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32494|NCT02037477|E2|Reported Event|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32193|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32194|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32195|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32196|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32197|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32198|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32199|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32200|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32201|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32202|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32203|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32204|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32205|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32206|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32207|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32208|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32209|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32210|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32211|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32212|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32213|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32214|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32215|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32216|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32217|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32218|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32219|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32495|NCT02037477|E1|Reported Event|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32220|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32221|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32222|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32223|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32224|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32225|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32226|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32227|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32228|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32229|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32230|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32231|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32232|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32233|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32234|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32235|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32236|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32237|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32238|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32239|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32240|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32241|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32242|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32243|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32244|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32245|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32246|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32579|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32247|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32248|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32249|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32250|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32251|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32252|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32253|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32254|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32255|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32256|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32257|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32258|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32259|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32260|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32261|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32262|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32263|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32264|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32265|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32266|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32267|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32268|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32269|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32270|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32271|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32272|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32273|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
33417|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32274|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32275|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32276|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32277|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32278|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32279|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32280|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32281|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32282|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32283|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32284|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32285|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32286|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32287|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32288|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32289|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32290|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32291|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32292|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32293|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32294|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32295|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32296|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32297|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32298|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32299|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32300|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
33418|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32301|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32302|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32303|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32304|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32305|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32306|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32307|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32308|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32309|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32310|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32311|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32312|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32313|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32314|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32315|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32316|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32317|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32318|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32319|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32320|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32321|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32322|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32323|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32324|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32325|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32326|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32327|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32580|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32328|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32329|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32330|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32331|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32332|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32333|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32334|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32335|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32336|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32337|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32338|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32339|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32340|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32341|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32342|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32343|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32344|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32345|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32346|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32347|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32348|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32349|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32350|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32351|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32352|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32353|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32354|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32581|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
72801|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
32355|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32356|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32357|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32358|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32359|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32360|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32361|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32362|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32363|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32364|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32365|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32366|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32367|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32368|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32369|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32370|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32371|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32372|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32373|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32374|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32375|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32376|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32377|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32378|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32379|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32380|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32381|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32582|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32382|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32383|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32384|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32385|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32386|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32387|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32388|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32389|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32390|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32391|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32392|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32393|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32394|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32395|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32396|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32397|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32398|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32399|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32400|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32401|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32402|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32403|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32404|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32405|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32406|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32407|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32408|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32583|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32409|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32410|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32411|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32412|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32413|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32414|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32415|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32416|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32417|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32418|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32419|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32420|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32421|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32422|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32423|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32424|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32425|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32426|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32427|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32428|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32429|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32430|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32431|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32432|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32433|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32434|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32435|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32584|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32436|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32437|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32438|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32439|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32440|NCT02038907|E14|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32441|NCT02038907|E13|Reported Event|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32442|NCT02038907|E12|Reported Event|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
32443|NCT02038907|E11|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
32444|NCT02038907|E10|Reported Event|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32445|NCT02038907|E9|Reported Event|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32446|NCT02038907|E8|Reported Event|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32447|NCT02038907|E7|Reported Event|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
32448|NCT02038907|E6|Reported Event|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32449|NCT02038907|E5|Reported Event|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
32450|NCT02038907|E4|Reported Event|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32451|NCT02038907|E3|Reported Event|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32452|NCT02038907|E2|Reported Event|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
32453|NCT02038907|E1|Reported Event|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
32454|NCT02038075|B3|Baseline|Total|Total of all reporting groups
32455|NCT02038075|B2|Baseline|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
32456|NCT02038075|B1|Baseline|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
32457|NCT02038075|P2|Participant Flow|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
32496|NCT02037425|B1|Baseline|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
33419|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32458|NCT02038075|P1|Participant Flow|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
32459|NCT02038075|O2|Outcome|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
32460|NCT02038075|O1|Outcome|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
32461|NCT02038075|E2|Reported Event|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
32462|NCT02038075|E1|Reported Event|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
32463|NCT02037477|B5|Baseline|Total|Total of all reporting groups
32464|NCT02037477|B4|Baseline|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
32465|NCT02037477|B3|Baseline|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
32466|NCT02037477|B2|Baseline|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
32467|NCT02037477|B1|Baseline|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
32468|NCT02037477|P4|Participant Flow|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
32469|NCT02037477|P3|Participant Flow|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
32470|NCT02037477|P2|Participant Flow|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
32471|NCT02037477|P1|Participant Flow|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
32472|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32473|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32474|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32475|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32476|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32477|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32478|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32479|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32480|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32481|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32482|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32483|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32484|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
32485|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
32486|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
32497|NCT02037425|P1|Participant Flow|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
32498|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32499|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32500|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32501|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32502|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32503|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32504|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32505|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32506|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32507|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32508|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32509|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32510|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32511|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32512|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32513|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32514|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32515|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32516|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32517|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32518|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32519|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32520|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32521|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32522|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32523|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32524|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32525|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32526|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32527|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32528|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32529|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32530|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32531|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32532|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32533|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32534|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
32535|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
32536|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
32537|NCT02037425|E1|Reported Event|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
32538|NCT02037347|B1|Baseline|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32539|NCT02037347|P1|Participant Flow|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32540|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32541|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32542|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32543|NCT02037347|E1|Reported Event|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
32544|NCT02036840|B1|Baseline|Penicillin Allergy|Antibiotic
32545|NCT02036840|P1|Participant Flow|Penicillin Allergy|Antibiotic
32546|NCT02036840|O1|Outcome|Penicillin Allergy|Antibiotic
32547|NCT02036840|E1|Reported Event|Penicillin Allergy|Antibiotic
32578|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
33420|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32548|NCT02036775|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment."
32549|NCT02036775|P6|Participant Flow|Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
32550|NCT02036775|P5|Participant Flow|Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
32551|NCT02036775|P4|Participant Flow|Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
32552|NCT02036775|P3|Participant Flow|Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
32553|NCT02036775|P2|Participant Flow|Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
32554|NCT02036775|P1|Participant Flow|Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
32555|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32556|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32557|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32558|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32559|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32560|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32561|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32562|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32563|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32564|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32565|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32566|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32567|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32568|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32569|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32570|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32571|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32572|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32573|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32574|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32575|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32576|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32577|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32585|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32586|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32587|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32588|NCT02036775|E3|Reported Event|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
32589|NCT02036775|E2|Reported Event|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
32590|NCT02036775|E1|Reported Event|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
32591|NCT02036424|B3|Baseline|Total|Total of all reporting groups
32592|NCT02036424|B2|Baseline|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
32593|NCT02036424|B1|Baseline|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
32594|NCT02036424|P2|Participant Flow|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
32595|NCT02036424|P1|Participant Flow|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
32596|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
32597|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
32598|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
32599|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
32600|NCT02036424|E2|Reported Event|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
32601|NCT02036424|E1|Reported Event|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
32602|NCT02035332|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32603|NCT02035332|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32604|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32605|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32606|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32607|NCT02035332|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
32608|NCT02036320|B1|Baseline|Overall|All subjects that were dispensed a test article during the study.
32609|NCT02036320|P2|Participant Flow|Test 2/Test 1|Subjects who received test lens 2 first and then received test lens 1.
32610|NCT02036320|P1|Participant Flow|Test 1/Test 2|Subjects who received test lens 1 first and then received test lens 2.
32611|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
32612|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
32613|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
32614|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
32615|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
32616|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
32617|NCT02036320|E2|Reported Event|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
32618|NCT02036320|E1|Reported Event|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
32619|NCT02035748|B1|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32620|NCT02035748|P1|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32621|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32622|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32623|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32624|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32625|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32626|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
32627|NCT02035748|E2|Reported Event|Ocriplasmin|All subjects exposed to the investigational product
32628|NCT02035748|E1|Reported Event|Pretreatment|All subjects consented to participate in the study prior to the initiation of study treatment
32629|NCT02035475|B1|Baseline|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
76017|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
32630|NCT02035475|P1|Participant Flow|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
32631|NCT02035475|O1|Outcome|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
32632|NCT02035475|O2|Outcome|Fenestrated Maryland BiPolar Instrument|The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
32633|NCT02035475|O1|Outcome|EndoWrist 1 Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side."
32634|NCT02035475|E1|Reported Event|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
32635|NCT02035345|B1|Baseline|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
32636|NCT02035345|P1|Participant Flow|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
32637|NCT02035345|O1|Outcome|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
32638|NCT02035345|O1|Outcome|Carboplain Slowed Infusion Group Reactors|Patients that received carboplatin via slowed infusion that developed a reaction
32639|NCT02035345|E1|Reported Event|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
32640|NCT02034877|B3|Baseline|Total|Total of all reporting groups
32641|NCT02034877|B2|Baseline|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32642|NCT02034877|B1|Baseline|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32643|NCT02034877|P2|Participant Flow|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32644|NCT02034877|P1|Participant Flow|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32645|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32646|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32647|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32648|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32649|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32650|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32651|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32652|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32653|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32654|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32655|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32656|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32657|NCT02034877|E2|Reported Event|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
32658|NCT02034877|E1|Reported Event|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
32659|NCT02034708|B3|Baseline|Total|Total of all reporting groups
32660|NCT02034708|B2|Baseline|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
33421|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32661|NCT02034708|B1|Baseline|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
32662|NCT02034708|P2|Participant Flow|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
32663|NCT02034708|P1|Participant Flow|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
32664|NCT02034708|O6|Outcome|Dotarem® (Reader 3)|Patients who received Dotarem® Results for reader 3
32665|NCT02034708|O5|Outcome|Gadovist® (Reader 3)|Patients who received Gadovist® Results for reader 3
32666|NCT02034708|O4|Outcome|Dotarem® (Reader 2)|Patients who received Dotarem® Results for reader 2
32667|NCT02034708|O3|Outcome|Gadovist® (Reader 2)|Patients who received Gadovist® Results for reader 2
32668|NCT02034708|O2|Outcome|Dotarem® (Reader 1)|Patients who received Dotarem® Results for reader 1
32669|NCT02034708|O1|Outcome|Gadovist® (Reader 1)|Patients who received Gadovist® Results for reader 1
32670|NCT02034708|E3|Reported Event|Total|Patients who received at least one injection of contrast agent
32671|NCT02034708|E2|Reported Event|Gadovist®|Patients who received Gadovist®
32672|NCT02034708|E1|Reported Event|Dotarem®|Patients who received Dotarem®
32673|NCT02034591|B1|Baseline|All Treatment Groups|All Randomized Participants
32674|NCT02034591|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32675|NCT02034591|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32676|NCT02034591|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32677|NCT02034591|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32678|NCT02034591|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32679|NCT02034591|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
32680|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32681|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32682|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32683|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32684|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32685|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32686|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32687|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32688|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32689|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32690|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32691|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32692|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32693|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32694|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32695|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32696|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32697|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32698|NCT02034591|E3|Reported Event|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
32699|NCT02034591|E2|Reported Event|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
32700|NCT02034591|E1|Reported Event|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
32701|NCT02034578|B1|Baseline|5mg Apixaban|After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period.
32702|NCT02034578|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
32703|NCT02034578|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
32704|NCT02034578|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
32705|NCT02034578|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
33422|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
32706|NCT02034578|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
32707|NCT02034578|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
32708|NCT02034578|O1|Outcome|5mg Apixaban|After a 10 hour fast, participants were randomized on Day 1 of Period 1 to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in Period 2 and Period 3.
32709|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32710|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32711|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32712|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32713|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32714|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32715|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32716|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32717|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32718|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32719|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32720|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32721|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32722|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32723|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32724|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32725|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32726|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32727|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
32728|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
32729|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
32730|NCT02034578|E3|Reported Event|5 mg Apixaban Via NGT Followed by Infant Formula (C)|In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT.
32731|NCT02034578|E2|Reported Event|5mg Apixaban Via NGT Followed by D5W (B)|In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT.
32732|NCT02034578|E1|Reported Event|5mg Apixaban Via Oral Syringe (A)|"After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3.~In Treatment A the single dose of 5 mg apixaban was administered via oral syringe."
32733|NCT02034565|B1|Baseline|All Treatment Groups|All Randomized Participants
32951|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32734|NCT02034565|P2|Participant Flow|Treatment B, Then Treatment A|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
32735|NCT02034565|P1|Participant Flow|Treatment A, Then Treatment B|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
32736|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32737|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32738|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32739|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32740|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32741|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32742|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32743|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32744|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32745|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32746|NCT02034565|E2|Reported Event|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
32747|NCT02034565|E1|Reported Event|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
32748|NCT02034162|B3|Baseline|Total|Total of all reporting groups
32749|NCT02034162|B2|Baseline|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32750|NCT02034162|B1|Baseline|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32751|NCT02034162|P3|Participant Flow|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
32752|NCT02034162|P2|Participant Flow|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32753|NCT02034162|P1|Participant Flow|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32754|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
32755|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
32756|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
32757|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
32758|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
32759|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
32760|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
32761|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
32762|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
32763|NCT02034162|O1|Outcome|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
32764|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
32765|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
32766|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
32767|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32768|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32952|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32769|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32770|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32771|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32772|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32773|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32774|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32775|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32776|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32777|NCT02034162|E3|Reported Event|OL Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
32778|NCT02034162|E2|Reported Event|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32779|NCT02034162|E1|Reported Event|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
32780|NCT02033317|B1|Baseline|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
32781|NCT02033317|P1|Participant Flow|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
32782|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
32783|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
32784|NCT02033317|E1|Reported Event|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally.
32785|NCT02033213|B3|Baseline|Total|Total of all reporting groups
32786|NCT02033213|B2|Baseline|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32787|NCT02033213|B1|Baseline|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32788|NCT02033213|P2|Participant Flow|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32789|NCT02033213|P1|Participant Flow|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32790|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32791|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32792|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32830|NCT02033174|O1|Outcome|Alcoholic Beverages (Red Wine Intake)|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine
32793|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32794|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32795|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32796|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32797|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32798|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32799|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32800|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32801|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32802|NCT02033213|E2|Reported Event|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32803|NCT02033213|E1|Reported Event|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
32804|NCT02033200|B3|Baseline|Total|Total of all reporting groups
32805|NCT02033200|B2|Baseline|Placebo|placebo
32806|NCT02033200|B1|Baseline|Active|Stendra 200 mg
32807|NCT02033200|P2|Participant Flow|Placebo|placebo
32808|NCT02033200|P1|Participant Flow|Active|Stendra 200 mg
32809|NCT02033200|O2|Outcome|Placebo|placebo
32810|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32811|NCT02033200|O2|Outcome|Placebo|placebo
32812|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32813|NCT02033200|O2|Outcome|Placebo|placebo
32814|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32815|NCT02033200|O2|Outcome|Placebo|placebo
32816|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32817|NCT02033200|O2|Outcome|Placebo|placebo
32818|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32819|NCT02033200|O2|Outcome|Placebo|placebo
32820|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32821|NCT02033200|O2|Outcome|Placebo|placebo
32822|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32823|NCT02033200|O2|Outcome|Placebo|placebo
32824|NCT02033200|O1|Outcome|Active|Stendra 200 mg
32825|NCT02033200|E2|Reported Event|Placebo|placebo
32826|NCT02033200|E1|Reported Event|Active|Stendra 200 mg
32827|NCT02033174|B1|Baseline|All Participants|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
32828|NCT02033174|P1|Participant Flow|All Study Participants|All study participants have received the same oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) and equivalent caloric intakes as sugar with water in the control group.
32829|NCT02033174|O2|Outcome|Oral Fat Diet|The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
32831|NCT02033174|E2|Reported Event|Oral Fat Diet|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
33701|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
32832|NCT02033174|E1|Reported Event|Alcoholic Beverages|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
32833|NCT02032901|B3|Baseline|Total|Total of all reporting groups
32834|NCT02032901|B2|Baseline|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32835|NCT02032901|B1|Baseline|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32836|NCT02032901|P2|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32837|NCT02032901|P1|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32838|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32839|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32840|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32841|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32842|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32843|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32844|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32845|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32846|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32847|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32848|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32849|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32850|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32851|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32852|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
33072|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
32853|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32854|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32855|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
32856|NCT02032901|E1|Reported Event|Daclatasvir + Sofosbuvir|All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
32857|NCT02032888|B4|Baseline|Total|Total of all reporting groups
32858|NCT02032888|B3|Baseline|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32859|NCT02032888|B2|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
32860|NCT02032888|B1|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32861|NCT02032888|P3|Participant Flow|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32862|NCT02032888|P2|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
32863|NCT02032888|P1|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
32864|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32865|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32866|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32867|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32868|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32869|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32870|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32871|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32872|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32873|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32874|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
32875|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32876|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32877|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32878|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32879|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32880|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32881|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32882|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32883|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
32884|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32885|NCT02032888|O1|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32886|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
32887|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
32888|NCT02032888|E3|Reported Event|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32889|NCT02032888|E2|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
32890|NCT02032888|E1|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
32891|NCT02032875|B3|Baseline|Total|Total of all reporting groups
32892|NCT02032875|B2|Baseline|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32893|NCT02032875|B1|Baseline|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32894|NCT02032875|P2|Participant Flow|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32895|NCT02032875|P1|Participant Flow|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32896|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32897|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32898|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32899|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32900|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32901|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32902|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32903|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32904|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32905|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32906|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32907|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32908|NCT02032875|O1|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32909|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32910|NCT02032875|E2|Reported Event|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32911|NCT02032875|E1|Reported Event|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
32912|NCT02032758|B3|Baseline|Total|Total of all reporting groups
32913|NCT02032758|B2|Baseline|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
32914|NCT02032758|B1|Baseline|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
32915|NCT02032758|P2|Participant Flow|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
32916|NCT02032758|P1|Participant Flow|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
32917|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
32918|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
32919|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
32920|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
32921|NCT02032758|E2|Reported Event|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
32922|NCT02032758|E1|Reported Event|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
32923|NCT02032706|B1|Baseline|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32924|NCT02032706|P1|Participant Flow|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32925|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32926|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32927|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32928|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32929|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32930|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32931|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32932|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32933|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32934|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32935|NCT02032706|E1|Reported Event|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
32936|NCT02032641|B1|Baseline|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
32937|NCT02032641|P1|Participant Flow|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
32938|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
32939|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
32940|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
32941|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
32942|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
32943|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
32944|NCT02032641|E2|Reported Event|Laser Left, Non-laser RIght|Group which had the right post-operative scar assigned to receive laser treatment
32945|NCT02032641|E1|Reported Event|Laser Right, Non-laser Left|Group which had the right post-operative scar assigned to receive laser treatment
32946|NCT02032420|B3|Baseline|Total|Total of all reporting groups
32947|NCT02032420|B2|Baseline|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32948|NCT02032420|B1|Baseline|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32949|NCT02032420|P2|Participant Flow|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32950|NCT02032420|P1|Participant Flow|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32953|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32954|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32955|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32956|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32957|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32958|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32959|NCT02032420|E2|Reported Event|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
32960|NCT02032420|E1|Reported Event|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
32961|NCT02032407|B1|Baseline|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32962|NCT02032407|P1|Participant Flow|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32963|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32964|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32965|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32966|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32967|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32968|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32969|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32970|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32971|NCT02032407|E1|Reported Event|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
32972|NCT02032212|B5|Baseline|Total|Total of all reporting groups
32973|NCT02032212|B4|Baseline|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
32974|NCT02032212|B3|Baseline|Sequence 3|Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
32975|NCT02032212|B2|Baseline|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
32976|NCT02032212|B1|Baseline|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
32977|NCT02032212|P4|Participant Flow|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
32978|NCT02032212|P3|Participant Flow|Sequence 3|Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
32979|NCT02032212|P2|Participant Flow|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
32980|NCT02032212|P1|Participant Flow|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
32981|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
32982|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
32983|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
32984|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
32985|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
32986|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
32987|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
32988|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
32989|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
32990|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
32991|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
32992|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
32993|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
32994|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
32995|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
32996|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
32997|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
32998|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
32999|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
33000|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
33001|NCT02032212|E4|Reported Event|Conventional Cigarette|Conventional cigarette (commercially available)
33002|NCT02032212|E3|Reported Event|Nicotine Inhalator|Nicotine inhalator 15mg
33003|NCT02032212|E2|Reported Event|EVP Flavoured|Flavoured e-vapour product
33004|NCT02032212|E1|Reported Event|EVP Unflavoured|Unflavoured e-vapour product
33165|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33005|NCT02031471|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33006|NCT02031471|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. Participants entered 8 weeks of follow-up either at the end of the 24-week open-label core study or after completion of the LTE. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
33007|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33008|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33009|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33010|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33011|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33012|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33013|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33014|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33015|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33016|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33017|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33018|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33019|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33020|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33021|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33022|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33023|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33024|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33025|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33026|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33027|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33028|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33029|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33030|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33031|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33032|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33033|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
33034|NCT02031471|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
33035|NCT02030600|B3|Baseline|Total|Total of all reporting groups
33036|NCT02030600|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33037|NCT02030600|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33073|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler
33074|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33038|NCT02030600|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33039|NCT02030600|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33040|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33041|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33042|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33043|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33044|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33075|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33076|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33077|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33702|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33045|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33046|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33047|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33048|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33049|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33050|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33051|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33078|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33079|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33080|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33703|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33052|NCT02030600|E2|Reported Event|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33053|NCT02030600|E1|Reported Event|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
33054|NCT02030574|B1|Baseline|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
33055|NCT02030574|P1|Participant Flow|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
33056|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
33057|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
33058|NCT02030574|E1|Reported Event|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
33059|NCT02030535|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.
33060|NCT02030535|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)
33061|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33062|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33063|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33064|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33065|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33066|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33067|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33068|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33069|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33070|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33071|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33704|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33082|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33083|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33084|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33085|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33086|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33087|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33088|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33089|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33090|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33091|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33092|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33093|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33094|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33095|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33096|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33097|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33098|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33099|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33100|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33101|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33102|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33103|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33104|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33105|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33106|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33107|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33108|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33109|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler."
33225|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33110|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler."
33111|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations ante meridiem (a.m.) dosing."
33112|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
33113|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
33114|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33115|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33116|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33117|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33118|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33119|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33120|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33121|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33122|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
33123|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33124|NCT02030535|E3|Reported Event|Tiotropium and Olodaterol FC|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing."
33125|NCT02030535|E2|Reported Event|Tio+Olo FDC|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33126|NCT02030535|E1|Reported Event|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
33127|NCT02029989|B3|Baseline|Total|Total of all reporting groups
33128|NCT02029989|B2|Baseline|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
33129|NCT02029989|B1|Baseline|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
33130|NCT02029989|P2|Participant Flow|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
33147|NCT02029755|P2|Participant Flow|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33423|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33131|NCT02029989|P1|Participant Flow|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
33132|NCT02029989|O2|Outcome|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
33133|NCT02029989|O1|Outcome|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
33134|NCT02029989|E2|Reported Event|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
33135|NCT02029989|E1|Reported Event|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
33136|NCT02029911|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33137|NCT02029911|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33138|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33139|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33140|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33141|NCT02029911|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33142|NCT02029755|B4|Baseline|Total|Total of all reporting groups
33143|NCT02029755|B3|Baseline|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33144|NCT02029755|B2|Baseline|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33145|NCT02029755|B1|Baseline|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33146|NCT02029755|P3|Participant Flow|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33705|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33148|NCT02029755|P1|Participant Flow|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33149|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33150|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33151|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33152|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33153|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33154|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33155|NCT02029755|E3|Reported Event|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33156|NCT02029755|E2|Reported Event|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33157|NCT02029755|E1|Reported Event|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
33158|NCT02029521|B3|Baseline|Total|Total of all reporting groups
33159|NCT02029521|B2|Baseline|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33160|NCT02029521|B1|Baseline|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33161|NCT02029521|P2|Participant Flow|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33162|NCT02029521|P1|Participant Flow|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33163|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33164|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
76018|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
33166|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33167|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33168|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33169|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33170|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33171|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33172|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33173|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33174|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33175|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33176|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33177|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33178|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33179|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33180|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33181|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33182|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33183|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33184|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33185|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33186|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33187|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33188|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33189|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33190|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33191|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33192|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33193|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33194|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33195|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33196|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33197|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
76019|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
33198|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33199|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33200|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33201|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33202|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33203|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33204|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33205|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33206|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33207|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33208|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33209|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33210|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33211|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33212|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33213|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33214|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33215|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33216|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33217|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33218|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33219|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33220|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33221|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33222|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33223|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33224|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33706|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33226|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33227|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33228|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33229|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33230|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33231|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33232|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33233|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33234|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33235|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33236|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33237|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33238|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33239|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33240|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33241|NCT02029521|E2|Reported Event|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
33242|NCT02029521|E1|Reported Event|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
33243|NCT02029417|B1|Baseline|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
33244|NCT02029417|P1|Participant Flow|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
33264|NCT02028780|P9|Participant Flow|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33424|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33425|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33245|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
33246|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
33247|NCT02029417|E1|Reported Event|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
33248|NCT02028780|B13|Baseline|Total|Total of all reporting groups
33249|NCT02028780|B12|Baseline|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33250|NCT02028780|B11|Baseline|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33251|NCT02028780|B10|Baseline|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33252|NCT02028780|B9|Baseline|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33253|NCT02028780|B8|Baseline|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33254|NCT02028780|B7|Baseline|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33255|NCT02028780|B6|Baseline|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33256|NCT02028780|B5|Baseline|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33257|NCT02028780|B4|Baseline|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33258|NCT02028780|B3|Baseline|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33259|NCT02028780|B2|Baseline|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
33260|NCT02028780|B1|Baseline|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
33261|NCT02028780|P12|Participant Flow|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33262|NCT02028780|P11|Participant Flow|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33263|NCT02028780|P10|Participant Flow|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33364|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33265|NCT02028780|P8|Participant Flow|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33266|NCT02028780|P7|Participant Flow|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33267|NCT02028780|P6|Participant Flow|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33268|NCT02028780|P5|Participant Flow|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33269|NCT02028780|P4|Participant Flow|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33270|NCT02028780|P3|Participant Flow|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33271|NCT02028780|P2|Participant Flow|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
33272|NCT02028780|P1|Participant Flow|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
33273|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33274|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33275|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33276|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33277|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33278|NCT02028780|O1|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33279|NCT02028780|O7|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33280|NCT02028780|O6|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33281|NCT02028780|O5|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33282|NCT02028780|O4|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33283|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33284|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33285|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33286|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33287|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33288|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33426|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33289|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33290|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33291|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33292|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33293|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33294|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33295|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33296|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33297|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33298|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33299|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33300|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33301|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33302|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33303|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33304|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33305|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33306|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33307|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33308|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33309|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33310|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33311|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33365|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33312|NCT02028780|O12|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33313|NCT02028780|O11|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33314|NCT02028780|O10|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33315|NCT02028780|O9|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33316|NCT02028780|O8|Outcome|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33317|NCT02028780|O7|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33318|NCT02028780|O6|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33319|NCT02028780|O5|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33320|NCT02028780|O4|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33321|NCT02028780|O3|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33322|NCT02028780|O2|Outcome|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
33323|NCT02028780|O1|Outcome|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
33324|NCT02028780|E12|Reported Event|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33325|NCT02028780|E11|Reported Event|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33326|NCT02028780|E10|Reported Event|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33327|NCT02028780|E9|Reported Event|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33328|NCT02028780|E8|Reported Event|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
33329|NCT02028780|E7|Reported Event|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
33330|NCT02028780|E6|Reported Event|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
33331|NCT02028780|E5|Reported Event|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
33332|NCT02028780|E4|Reported Event|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
33333|NCT02028780|E3|Reported Event|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
33334|NCT02028780|E2|Reported Event|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
33335|NCT02028780|E1|Reported Event|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
33336|NCT02028767|B1|Baseline|Fixed Dose Combination vs. Separate Tablets|12.5 mg Empagliflozin / 500mg metformin fixed dose combination vs. free combination of 2.5 mg tablet Empagliflozin, 10 mg tablet Empagliflozin and 500 mg tablet Metformin
33366|NCT02028754|E2|Reported Event|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33707|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33337|NCT02028767|P2|Participant Flow|Separate Tablets First, Then Fixed Dose Combination (FDC)|"free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet first,~then Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
33338|NCT02028767|P1|Participant Flow|Fixed Dose Combination (FDC) First, Then Separate Tablets|"Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin first,~then free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
33339|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
33340|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
33341|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
33342|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
33343|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
33344|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
33345|NCT02028767|E2|Reported Event|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
33346|NCT02028767|E1|Reported Event|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
33347|NCT02028754|B3|Baseline|Total|Total of all reporting groups
33348|NCT02028754|B2|Baseline|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33349|NCT02028754|B1|Baseline|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33350|NCT02028754|P2|Participant Flow|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33351|NCT02028754|P1|Participant Flow|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33352|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33353|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33354|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33355|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33356|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33357|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33358|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33359|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33360|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33361|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33362|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33363|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33414|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33367|NCT02028754|E1|Reported Event|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
33368|NCT02028676|B10|Baseline|Total|Total of all reporting groups
33369|NCT02028676|B9|Baseline|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
33370|NCT02028676|B8|Baseline|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
33371|NCT02028676|B7|Baseline|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
33372|NCT02028676|B6|Baseline|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
33373|NCT02028676|B5|Baseline|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33374|NCT02028676|B4|Baseline|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33375|NCT02028676|B3|Baseline|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33376|NCT02028676|B2|Baseline|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33377|NCT02028676|B1|Baseline|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33378|NCT02028676|P9|Participant Flow|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
33379|NCT02028676|P8|Participant Flow|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
33380|NCT02028676|P7|Participant Flow|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
33381|NCT02028676|P6|Participant Flow|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
33415|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33416|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
76020|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
33382|NCT02028676|P5|Participant Flow|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33383|NCT02028676|P4|Participant Flow|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33384|NCT02028676|P3|Participant Flow|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33385|NCT02028676|P2|Participant Flow|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33386|NCT02028676|P1|Participant Flow|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33387|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33388|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33389|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33390|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33391|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33392|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33393|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33394|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33395|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33396|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33397|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33398|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33399|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33400|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33401|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33402|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33403|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33404|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33405|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33406|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33407|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33408|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33409|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33410|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33411|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33412|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33413|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33708|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33427|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33428|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33429|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33430|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33431|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33432|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33433|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33434|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33435|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33436|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33437|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33438|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33439|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33440|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33441|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33442|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33443|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33444|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33445|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33446|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33447|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33448|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33449|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33450|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33451|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33452|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33453|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33454|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33690|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33455|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33456|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33457|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33458|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33459|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33460|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33461|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33462|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33463|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33464|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33465|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33691|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
76021|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
33466|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33467|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33468|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33469|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33470|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33471|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33472|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33473|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33474|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33475|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33497|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33709|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33476|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33477|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33478|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33479|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33480|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33481|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33482|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33483|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33484|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33485|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33486|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33692|NCT02025907|E2|Reported Event|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33487|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33488|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33489|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33490|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33491|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33492|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33493|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33494|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33495|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33496|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33593|NCT02027844|B2|Baseline|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33498|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33499|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33500|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33501|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33502|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33503|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33504|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33505|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33506|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33507|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33508|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33594|NCT02027844|B1|Baseline|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33509|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33510|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33511|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33512|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33513|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33514|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33515|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33516|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33517|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33518|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33536|NCT02028676|O3|Outcome|ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
33685|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33519|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33520|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
33521|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33522|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33523|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33524|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33525|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33526|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33527|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33528|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33529|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33530|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
33531|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
33532|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33533|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33534|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33535|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
33592|NCT02027844|B3|Baseline|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33693|NCT02025907|E1|Reported Event|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33537|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33538|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33539|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
33540|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33541|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33542|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
33543|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33544|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33545|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33546|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33547|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33559|NCT02028325|P1|Participant Flow|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
76022|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
33548|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33549|NCT02028676|E9|Reported Event|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
33550|NCT02028676|E8|Reported Event|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
33551|NCT02028676|E7|Reported Event|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
33552|NCT02028676|E6|Reported Event|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
33553|NCT02028676|E5|Reported Event|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33554|NCT02028676|E4|Reported Event|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33555|NCT02028676|E3|Reported Event|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
33556|NCT02028676|E2|Reported Event|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33557|NCT02028676|E1|Reported Event|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
33558|NCT02028325|B1|Baseline|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
33591|NCT02027844|B4|Baseline|Total|Total of all reporting groups
33694|NCT02025647|B1|Baseline|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33560|NCT02028325|O1|Outcome|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
33561|NCT02028325|E1|Reported Event|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
33562|NCT02028065|B4|Baseline|Total|Total of all reporting groups
33563|NCT02028065|B3|Baseline|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33564|NCT02028065|B2|Baseline|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33565|NCT02028065|B1|Baseline|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33566|NCT02028065|P3|Participant Flow|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33567|NCT02028065|P2|Participant Flow|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33568|NCT02028065|P1|Participant Flow|Placebo|Administration of 3 single intravenous (IV) doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33569|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33570|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33571|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33572|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33573|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33574|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33575|NCT02028065|E3|Reported Event|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33576|NCT02028065|E2|Reported Event|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33577|NCT02028065|E1|Reported Event|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
33578|NCT02027883|B3|Baseline|Total|Total of all reporting groups
33579|NCT02027883|B2|Baseline|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
33580|NCT02027883|B1|Baseline|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
33581|NCT02027883|P2|Participant Flow|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
33582|NCT02027883|P1|Participant Flow|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
33583|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values~The educated T shock setting method was successful in 70% of the patients. 35 out of 50 patients Ventricular Fibrillation was induced with the educated T- shock method. Of the 12 patients that were did not have Ventricular fibrillation induced with the nominal T-shock method, they were all successfully induced with the educated T-Shock method."
33584|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust~The standard T-Shock method was successful in 76% of the patients. 38 out of 50 patients Ventricular Fibrillation was induced with the nominal T shock method. In contrast, 87 % or 13 out of 15 that failed to induce Ventricular Fibrillation using the educated T-Shock method was successfully induced when crossed to the nominal T-shock method."
33585|NCT02027883|O2|Outcome|Experimental Parameter|Educated T shock setting: Experimental Parameter Set 2 Programming Values.
33586|NCT02027883|O1|Outcome|Nominal Parameter|Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust.
33587|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
33588|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
33589|NCT02027883|E2|Reported Event|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
33590|NCT02027883|E1|Reported Event|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
33595|NCT02027844|P3|Participant Flow|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33596|NCT02027844|P2|Participant Flow|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33597|NCT02027844|P1|Participant Flow|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33598|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33599|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33600|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33601|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33602|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33603|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33604|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33605|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33606|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33607|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33608|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33609|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33610|NCT02027844|E3|Reported Event|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
33611|NCT02027844|E2|Reported Event|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
33612|NCT02027844|E1|Reported Event|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
33613|NCT02027402|B3|Baseline|Total|Total of all reporting groups
33614|NCT02027402|B2|Baseline|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33615|NCT02027402|B1|Baseline|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33616|NCT02027402|P2|Participant Flow|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33617|NCT02027402|P1|Participant Flow|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33618|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33619|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33620|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33621|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33622|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33623|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33686|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33624|NCT02027402|O2|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33625|NCT02027402|O1|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33626|NCT02027402|E2|Reported Event|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
33627|NCT02027402|E1|Reported Event|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
33628|NCT02027311|B3|Baseline|Total|Total of all reporting groups
33629|NCT02027311|B2|Baseline|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33630|NCT02027311|B1|Baseline|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33631|NCT02027311|P2|Participant Flow|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33632|NCT02027311|P1|Participant Flow|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33633|NCT02027311|O2|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33634|NCT02027311|O1|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33635|NCT02027311|O2|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33636|NCT02027311|O1|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33637|NCT02027311|E2|Reported Event|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33687|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33688|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33689|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33695|NCT02025647|P1|Participant Flow|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33638|NCT02027311|E1|Reported Event|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
33639|NCT02027272|B3|Baseline|Total|Total of all reporting groups
33640|NCT02027272|B2|Baseline|Placebo|Placebo, 2 doses, 12 hours apart
33641|NCT02027272|B1|Baseline|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
33642|NCT02027272|P2|Participant Flow|Placebo|Placebo, 2 doses, 12 hours apart
33643|NCT02027272|P1|Participant Flow|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
33644|NCT02027272|O2|Outcome|Placebo|Placebo, 2 doses, 12 hours apart
33645|NCT02027272|O1|Outcome|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
33646|NCT02027272|E2|Reported Event|Placebo|Placebo, 2 doses, 12 hours apart
33647|NCT02027272|E1|Reported Event|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
33648|NCT02026206|B3|Baseline|Total|Total of all reporting groups
33649|NCT02026206|B2|Baseline|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33650|NCT02026206|B1|Baseline|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33651|NCT02026206|P2|Participant Flow|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33652|NCT02026206|P1|Participant Flow|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33653|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33654|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33655|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33656|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33657|NCT02026206|E2|Reported Event|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33658|NCT02026206|E1|Reported Event|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
33659|NCT02026193|B3|Baseline|Total|Total of all reporting groups
33660|NCT02026193|B2|Baseline|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
33661|NCT02026193|B1|Baseline|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
33662|NCT02026193|P2|Participant Flow|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
33663|NCT02026193|P1|Participant Flow|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
33664|NCT02026193|O2|Outcome|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
33665|NCT02026193|O1|Outcome|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
33666|NCT02026193|E2|Reported Event|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
33667|NCT02026193|E1|Reported Event|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
33668|NCT02026141|B3|Baseline|Total|Total of all reporting groups
33669|NCT02026141|B2|Baseline|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
33670|NCT02026141|B1|Baseline|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr~Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA.~Dexmedetomidine"
33671|NCT02026141|P2|Participant Flow|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
33672|NCT02026141|P1|Participant Flow|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
33673|NCT02026141|O2|Outcome|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
33674|NCT02026141|O1|Outcome|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
33675|NCT02026141|E2|Reported Event|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
33676|NCT02026141|E1|Reported Event|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
33677|NCT02025907|B3|Baseline|Total|Total of all reporting groups
33678|NCT02025907|B2|Baseline|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33679|NCT02025907|B1|Baseline|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33680|NCT02025907|P2|Participant Flow|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33681|NCT02025907|P1|Participant Flow|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33682|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33683|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
33684|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
33710|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33711|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33712|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33713|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33714|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33715|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33716|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33717|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33718|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33719|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33720|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33721|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33722|NCT02025647|E1|Reported Event|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
33723|NCT02024971|B1|Baseline|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33724|NCT02024971|P1|Participant Flow|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33725|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33726|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33727|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33728|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33729|NCT02024971|E1|Reported Event|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
33730|NCT02024867|B3|Baseline|Total|Total of all reporting groups
33731|NCT02024867|B2|Baseline|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33732|NCT02024867|B1|Baseline|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33733|NCT02024867|P2|Participant Flow|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33734|NCT02024867|P1|Participant Flow|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33735|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33736|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33737|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33738|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33739|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33740|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33741|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33742|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33743|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33744|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33745|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33746|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33747|NCT02024867|E2|Reported Event|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33748|NCT02024867|E1|Reported Event|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
33749|NCT02024698|B1|Baseline|Overall Study Group|Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
33750|NCT02024698|P2|Participant Flow|Omafilcon A First, Then Etafilcon A|Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
33751|NCT02024698|P1|Participant Flow|Etafilcon A First, Then Omafilcon A|Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.
33752|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33753|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33754|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33755|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33756|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33757|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33758|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33759|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33760|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33761|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33762|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33763|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33764|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33765|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33766|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33767|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33768|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33769|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33770|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33771|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33772|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
33773|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
33774|NCT02024698|E2|Reported Event|Etafilcon A|Study participants are randomized to wear etafilcon A lenses.
33775|NCT02024698|E1|Reported Event|Omafilcon A|Study participants are randomized to wear omafilcon A lenses.
33776|NCT02024165|B1|Baseline|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
33777|NCT02024165|P1|Participant Flow|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
33778|NCT02024165|O2|Outcome|Electrode Sensor, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
33779|NCT02024165|O1|Outcome|Electrode Sensor, FSE|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE
33780|NCT02024165|E1|Reported Event|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and ultrasound
33781|NCT02023801|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33782|NCT02023801|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33783|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33784|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33785|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33786|NCT02023801|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
33787|NCT02023268|B3|Baseline|Total|Total of all reporting groups
33788|NCT02023268|B2|Baseline|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
33789|NCT02023268|B1|Baseline|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
33790|NCT02023268|P2|Participant Flow|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
33791|NCT02023268|P1|Participant Flow|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
33792|NCT02023268|O2|Outcome|Vismed|Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
33793|NCT02023268|O1|Outcome|T2762|T2762: drop in each eye 3 to 6 times daily during 84 days
33794|NCT02023268|E2|Reported Event|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
33795|NCT02023268|E1|Reported Event|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
33796|NCT02023125|B3|Baseline|Total|Total of all reporting groups
33797|NCT02023125|B2|Baseline|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33815|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33798|NCT02023125|B1|Baseline|Group 1 (Treatment Sequence AB or BA)|Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
33799|NCT02023125|P3|Participant Flow|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33800|NCT02023125|P2|Participant Flow|Group 1: Treatment B First, Then Treatment A|Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
33801|NCT02023125|P1|Participant Flow|Group 1: Treatment A First, Then Treatment B|Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
33802|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33803|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33804|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33805|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33806|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33807|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33808|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33809|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33810|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
33811|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33812|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33813|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33814|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33816|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33817|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33818|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33819|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33820|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33821|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33822|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33823|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33824|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33825|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33826|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33827|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33828|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33829|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33830|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33831|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33832|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33833|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33834|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33835|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33891|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33836|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33837|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33838|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33839|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33840|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33841|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33842|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33843|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33844|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33845|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33846|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33847|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33848|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33849|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33850|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33851|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33852|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33853|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33854|NCT02023125|E5|Reported Event|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
33855|NCT02023125|E4|Reported Event|Group 2: Period 2 (Esomeprazole Alone)|Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
33892|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
34640|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
33856|NCT02023125|E3|Reported Event|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
33857|NCT02023125|E2|Reported Event|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
33858|NCT02023125|E1|Reported Event|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
33859|NCT02023112|B3|Baseline|Total|Total of all reporting groups
33860|NCT02023112|B2|Baseline|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33861|NCT02023112|B1|Baseline|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33862|NCT02023112|P2|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33863|NCT02023112|P1|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
33864|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33865|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33866|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33867|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33868|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33869|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33870|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33871|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33872|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33873|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33874|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
33875|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
33876|NCT02023112|E4|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
33877|NCT02023112|E3|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants
33878|NCT02023112|E2|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants
33879|NCT02023112|E1|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants
33880|NCT02023099|B4|Baseline|Total|Total of all reporting groups
33881|NCT02023099|B3|Baseline|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33882|NCT02023099|B2|Baseline|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33883|NCT02023099|B1|Baseline|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33884|NCT02023099|P3|Participant Flow|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33885|NCT02023099|P2|Participant Flow|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33886|NCT02023099|P1|Participant Flow|Substudy 1, Arm A: DB 2-DAA|Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis
33887|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33888|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33889|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33890|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
34641|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
33893|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33894|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33895|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33896|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33897|NCT02023099|E4|Reported Event|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
33898|NCT02023099|E3|Reported Event|Substudy 1, Arm B: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
33899|NCT02023099|E2|Reported Event|Substudy 1, Arm B: DB Placebo|DB placebo QD for 12 weeks in participants without cirrhosis
33900|NCT02023099|E1|Reported Event|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis.
33901|NCT02022670|B4|Baseline|Total|Total of all reporting groups
33902|NCT02022670|B3|Baseline|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33903|NCT02022670|B2|Baseline|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33904|NCT02022670|B1|Baseline|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
33905|NCT02022670|P3|Participant Flow|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33906|NCT02022670|P2|Participant Flow|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33907|NCT02022670|P1|Participant Flow|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
33908|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33909|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33910|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
33911|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33912|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33913|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
33914|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33915|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33916|NCT02022670|O1|Outcome|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
33917|NCT02022670|E3|Reported Event|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33918|NCT02022670|E2|Reported Event|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
33919|NCT02022670|E1|Reported Event|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
33920|NCT02022085|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33921|NCT02022085|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33922|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33941|NCT02022020|B1|Baseline|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33923|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33924|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33925|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33926|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33927|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33928|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33929|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33930|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33931|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33932|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33933|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33934|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33935|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33936|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33937|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33938|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33939|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33940|NCT02022085|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
33942|NCT02022020|P1|Participant Flow|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33943|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33944|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33945|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33946|NCT02022020|E1|Reported Event|Dabigatran (Pradax® in Canada; Pradaxa® in the United States|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
33947|NCT02021461|B1|Baseline|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
33948|NCT02021461|P1|Participant Flow|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
33949|NCT02021461|O3|Outcome|ESL Tutti-Frutti Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Tutti-Frutti taste"
33950|NCT02021461|O2|Outcome|ESL Grape Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Grape taste"
33951|NCT02021461|O1|Outcome|ESL Banana Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Banana taste"
33952|NCT02021461|E1|Reported Event|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
33953|NCT02021071|B3|Baseline|Total|Total of all reporting groups
33954|NCT02021071|B2|Baseline|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
33955|NCT02021071|B1|Baseline|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
33956|NCT02021071|P2|Participant Flow|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
33957|NCT02021071|P1|Participant Flow|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
33958|NCT02021071|O2|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
33959|NCT02021071|O1|Outcome|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
33960|NCT02021071|O1|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
33961|NCT02021071|E2|Reported Event|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
33962|NCT02021071|E1|Reported Event|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
33963|NCT02020941|B1|Baseline|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33998|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
33999|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
34642|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
33964|NCT02020941|P1|Participant Flow|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33965|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33966|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33967|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33968|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33969|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33970|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33971|NCT02020941|E1|Reported Event|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
33972|NCT02020863|B1|Baseline|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
33973|NCT02020863|P1|Participant Flow|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
33974|NCT02020863|O1|Outcome|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
33975|NCT02020863|E1|Reported Event|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
33976|NCT02020577|B3|Baseline|Total|Total of all reporting groups
33977|NCT02020577|B2|Baseline|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33978|NCT02020577|B1|Baseline|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33979|NCT02020577|P2|Participant Flow|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33980|NCT02020577|P1|Participant Flow|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33981|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33982|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33983|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33984|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33985|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33986|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33987|NCT02020577|E2|Reported Event|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33988|NCT02020577|E1|Reported Event|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
33989|NCT02020512|B1|Baseline|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
33990|NCT02020512|P1|Participant Flow|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
33991|NCT02020512|O1|Outcome|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
33992|NCT02020512|E1|Reported Event|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
33993|NCT02020031|B3|Baseline|Total|Total of all reporting groups
33994|NCT02020031|B2|Baseline|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
33995|NCT02020031|B1|Baseline|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
33996|NCT02020031|P2|Participant Flow|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
33997|NCT02020031|P1|Participant Flow|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
34643|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34000|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
34001|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
34002|NCT02020031|E2|Reported Event|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
34003|NCT02020031|E1|Reported Event|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
34004|NCT02019563|B3|Baseline|Total|Total of all reporting groups
34005|NCT02019563|B2|Baseline|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34006|NCT02019563|B1|Baseline|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34007|NCT02019563|P2|Participant Flow|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34008|NCT02019563|P1|Participant Flow|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34009|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34010|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34011|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34012|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34013|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34014|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34015|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34016|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34017|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34064|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34644|NCT02013687|E4|Reported Event|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34018|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34019|NCT02019563|E2|Reported Event|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
34020|NCT02019563|E1|Reported Event|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
34021|NCT02017574|B3|Baseline|Total|Total of all reporting groups
34022|NCT02017574|B2|Baseline|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34023|NCT02017574|B1|Baseline|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34024|NCT02017574|P2|Participant Flow|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34025|NCT02017574|P1|Participant Flow|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34026|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34027|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34028|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34029|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34030|NCT02017574|E2|Reported Event|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34031|NCT02017574|E1|Reported Event|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
34032|NCT02017093|B3|Baseline|Total|Total of all reporting groups
34033|NCT02017093|B2|Baseline|Control|Patients admitted to rehabilitation center after a stroke.
34034|NCT02017093|B1|Baseline|Study|Patients admitted to rehabilitation center after a stroke.
34035|NCT02017093|P2|Participant Flow|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34036|NCT02017093|P1|Participant Flow|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34037|NCT02017093|O2|Outcome|Control Group|"Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.~control treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
34038|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.~Error Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
34039|NCT02017093|O2|Outcome|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34040|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34041|NCT02017093|E2|Reported Event|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34042|NCT02017093|E1|Reported Event|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
34043|NCT02017015|B1|Baseline|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34044|NCT02017015|P1|Participant Flow|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34045|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34046|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34047|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34048|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34049|NCT02017015|E1|Reported Event|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
34050|NCT02016963|B1|Baseline|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34051|NCT02016963|P1|Participant Flow|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34052|NCT02016963|O1|Outcome|Raxibacumab IV|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34053|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34054|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34055|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34056|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34057|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34058|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34059|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34060|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34061|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34062|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34063|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34645|NCT02013687|E3|Reported Event|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34065|NCT02016963|E1|Reported Event|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
34066|NCT02016690|B1|Baseline|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34067|NCT02016690|P1|Participant Flow|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34068|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34069|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34070|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34071|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34072|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34073|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34074|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34075|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34076|NCT02016690|E1|Reported Event|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
34077|NCT02016625|B3|Baseline|Total|Total of all reporting groups
34078|NCT02016625|B2|Baseline|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
34079|NCT02016625|B1|Baseline|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
34080|NCT02016625|P2|Participant Flow|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
34081|NCT02016625|P1|Participant Flow|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
34082|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34083|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
34084|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34085|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
34086|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34087|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by tac treatment] in period 2
34088|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1, treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34089|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
34090|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34091|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
34092|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
34093|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
34094|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34095|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
34096|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34646|NCT02013687|E2|Reported Event|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34097|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
34098|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34099|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
34100|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34101|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
34102|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34103|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
34104|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
34105|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
34106|NCT02016625|E6|Reported Event|Tac+FDV|Tacrolimus 0.5 mg + FDV 120 mg
34107|NCT02016625|E5|Reported Event|Cyclo+FDV|Cyclosporine 50 mg + FDV 120 mg
34108|NCT02016625|E4|Reported Event|FDV (ff Tac)|FDV 120 mg (followed by tacrolimus)
34109|NCT02016625|E3|Reported Event|FDV (ff Cyclo)|FDV 120 mg (followed by cyclosporine)
34110|NCT02016625|E2|Reported Event|Tacrolimus (Tac)|Tacrolimus (tac) 0.5 mg
34111|NCT02016625|E1|Reported Event|Cyclosporine (Cyclo)|Cyclosporine (cyclo) 50 mg
34112|NCT02016482|B3|Baseline|Total|Total of all reporting groups
34113|NCT02016482|B2|Baseline|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34114|NCT02016482|B1|Baseline|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34115|NCT02016482|P2|Participant Flow|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34116|NCT02016482|P1|Participant Flow|Placebo|Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA 80) mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34117|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34118|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34119|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34120|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34121|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34122|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34123|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34124|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34125|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34126|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34127|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34128|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34129|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34130|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34131|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34132|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34133|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34134|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34135|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34136|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34137|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34138|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34139|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34140|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34141|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34142|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34143|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34144|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34145|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34146|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34147|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34148|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34149|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34150|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34151|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34152|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34153|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34154|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34155|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34156|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34157|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34158|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34159|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34160|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34161|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34162|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34163|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34164|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34165|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34166|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34167|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34168|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34169|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34170|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34171|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34172|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34173|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34174|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34175|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34176|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34177|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34178|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34179|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34180|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34181|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34182|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34183|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34184|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34185|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34186|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34187|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34188|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34189|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34190|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34191|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34192|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34193|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34194|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34195|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34196|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34197|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34198|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34199|NCT02016482|E4|Reported Event|Adalimumab EOW/Adalimumab EOW (Period B)|Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from week 27 through Week 51.
34200|NCT02016482|E3|Reported Event|Placebo/Adalimumab EOW (Period B)|Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
34201|NCT02016482|E2|Reported Event|Adalimumab EOW (Period A)|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.
34202|NCT02016482|E1|Reported Event|Placebo (Period A)|Period A: Placebo sc eow for 25 weeks.
34203|NCT02016170|B4|Baseline|Total|Total of all reporting groups
34204|NCT02016170|B3|Baseline|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
34205|NCT02016170|B2|Baseline|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
34206|NCT02016170|B1|Baseline|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
34207|NCT02016170|P3|Participant Flow|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
34208|NCT02016170|P2|Participant Flow|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
34647|NCT02013687|E1|Reported Event|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34209|NCT02016170|P1|Participant Flow|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
34210|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
34211|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
34212|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
34213|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
34214|NCT02016170|E3|Reported Event|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
34215|NCT02016170|E2|Reported Event|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
34216|NCT02016170|E1|Reported Event|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
34217|NCT02015910|B3|Baseline|Total|Total of all reporting groups
34218|NCT02015910|B2|Baseline|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
34219|NCT02015910|B1|Baseline|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
34220|NCT02015910|P2|Participant Flow|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
34221|NCT02015910|P1|Participant Flow|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
34222|NCT02015910|O2|Outcome|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
34223|NCT02015910|O1|Outcome|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
34224|NCT02015910|E2|Reported Event|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
34225|NCT02015910|E1|Reported Event|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
34226|NCT02015793|B3|Baseline|Total|Total of all reporting groups
34227|NCT02015793|B2|Baseline|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34228|NCT02015793|B1|Baseline|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34229|NCT02015793|P2|Participant Flow|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34230|NCT02015793|P1|Participant Flow|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34231|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34232|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34233|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34234|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34235|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34236|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34237|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34238|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34239|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34240|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34241|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34242|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34243|NCT02015793|O4|Outcome|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
34244|NCT02015793|O3|Outcome|Low Induction Dose (Open-label Extension Period)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
76023|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
34245|NCT02015793|O2|Outcome|Standard Induction Dose (Double-blind Period)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34246|NCT02015793|O1|Outcome|Low Induction Dose (Double-blind Period)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34247|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34248|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34249|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34250|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34251|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34252|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34253|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34254|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34255|NCT02015793|E4|Reported Event|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
34256|NCT02015793|E3|Reported Event|Low Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
34257|NCT02015793|E2|Reported Event|Standard Induction Dose (Double-blind)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
34258|NCT02015793|E1|Reported Event|Low Induction Dose (Double-blind)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
34259|NCT02015676|B4|Baseline|Total|Total of all reporting groups
34260|NCT02015676|B3|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34261|NCT02015676|B2|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34262|NCT02015676|B1|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
34263|NCT02015676|P3|Participant Flow|Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34264|NCT02015676|P2|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34284|NCT02015546|P1|Participant Flow|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
76024|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
34265|NCT02015676|P1|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
34266|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34267|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34268|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34269|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34270|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34271|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34272|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34273|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34274|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34275|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34276|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34277|NCT02015676|E1|Reported Event|Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
34278|NCT02015546|B4|Baseline|Total|Total of all reporting groups
34279|NCT02015546|B3|Baseline|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34280|NCT02015546|B2|Baseline|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34281|NCT02015546|B1|Baseline|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34282|NCT02015546|P3|Participant Flow|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34283|NCT02015546|P2|Participant Flow|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34285|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34286|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34287|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34288|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34289|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34290|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34291|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34292|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34293|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34294|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34295|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34296|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34297|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34298|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34299|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34300|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34301|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34302|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34303|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34304|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34305|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34306|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34307|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34308|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34309|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34310|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34311|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34312|NCT02015546|E3|Reported Event|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34313|NCT02015546|E2|Reported Event|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34314|NCT02015546|E1|Reported Event|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
34315|NCT02015221|B3|Baseline|Total|Total of all reporting groups
34316|NCT02015221|B2|Baseline|Standard Compression Garments|Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
34317|NCT02015221|B1|Baseline|ACTitouch|ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
34345|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
34318|NCT02015221|P2|Participant Flow|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
34319|NCT02015221|P1|Participant Flow|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
34320|NCT02015221|O2|Outcome|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
34321|NCT02015221|O1|Outcome|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
34322|NCT02015221|E2|Reported Event|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
34323|NCT02015221|E1|Reported Event|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
34324|NCT02015195|B8|Baseline|Total|Total of all reporting groups
34325|NCT02015195|B7|Baseline|Heated Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Heated Tap Water (40 degrees Celsius)~No treatment~8 males, 8 females treated"
34326|NCT02015195|B6|Baseline|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment~8 makes, 8 females treated"
34327|NCT02015195|B5|Baseline|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~10 males, 6 females treated"
34328|NCT02015195|B4|Baseline|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~1 female treated; adverse local skin reaction; study arm therefore withdrawn"
34329|NCT02015195|B3|Baseline|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~9 males, 7 females treated"
34330|NCT02015195|B2|Baseline|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~8 males, 8 females treated"
34331|NCT02015195|B1|Baseline|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~11 males, 5 females treated"
34332|NCT02015195|P7|Participant Flow|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34333|NCT02015195|P6|Participant Flow|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment).~No treatment"
34334|NCT02015195|P5|Participant Flow|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34335|NCT02015195|P4|Participant Flow|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34336|NCT02015195|P3|Participant Flow|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34337|NCT02015195|P2|Participant Flow|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34338|NCT02015195|P1|Participant Flow|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
34339|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
34340|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
34341|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
34342|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
34343|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
34344|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
34346|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
34347|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
34348|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
34349|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
34350|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
34351|NCT02015195|E7|Reported Event|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
34352|NCT02015195|E6|Reported Event|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
34353|NCT02015195|E5|Reported Event|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
34354|NCT02015195|E4|Reported Event|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The first patient treated had an adverse local skin reaction, so this study arm was discontinued"
34355|NCT02015195|E3|Reported Event|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
34356|NCT02015195|E2|Reported Event|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
34357|NCT02015195|E1|Reported Event|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
34358|NCT02014480|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
34359|NCT02014480|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
34360|NCT02014480|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
34361|NCT02014480|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
34362|NCT02014480|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
34363|NCT02014480|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
34364|NCT02014480|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol trifenatate (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
34365|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34366|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34367|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34368|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34369|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34370|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34508|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
76025|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
34371|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34372|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34373|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34374|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34375|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34376|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34377|NCT02014480|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34378|NCT02014480|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34379|NCT02014480|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
34380|NCT02014467|B3|Baseline|Total|Total of all reporting groups
34381|NCT02014467|B2|Baseline|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34382|NCT02014467|B1|Baseline|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34383|NCT02014467|P2|Participant Flow|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34384|NCT02014467|P1|Participant Flow|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34385|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34386|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34387|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34388|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34389|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34390|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34391|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34392|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34393|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34394|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34395|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34396|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34397|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34398|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34399|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34400|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34401|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34402|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34403|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34404|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34405|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34406|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34407|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34408|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34409|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34410|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34411|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34412|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34413|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34414|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34415|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34416|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34417|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34418|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34419|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34625|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34420|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34421|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34422|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34423|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34424|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34425|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34426|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34427|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34428|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34429|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34430|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34431|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34432|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34433|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34434|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34435|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34436|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34437|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34438|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34439|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34440|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34441|NCT02014467|E2|Reported Event|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
34442|NCT02014467|E1|Reported Event|Denosumab 60mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
34626|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34443|NCT02014441|B1|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34444|NCT02014441|P1|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34445|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34446|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34447|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34448|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34449|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34450|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34451|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34452|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34453|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34454|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34455|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34456|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34457|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34458|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34459|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34460|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34461|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34462|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34463|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34464|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34465|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34466|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34467|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34468|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34469|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34470|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34471|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34472|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34473|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34474|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34475|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34476|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34477|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34478|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34479|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34480|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34481|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34482|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34483|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34484|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34485|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34486|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34487|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34488|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34489|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34490|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34491|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34492|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34493|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34494|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34495|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34496|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34497|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34498|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34499|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34500|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34501|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34502|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34503|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34504|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34505|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34506|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34507|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34627|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34509|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34510|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34511|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34512|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34513|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34514|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34515|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34516|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34517|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34518|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34519|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34520|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34521|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34522|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34523|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34524|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34525|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34526|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34527|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34528|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34529|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34530|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34531|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
34532|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
34533|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34534|NCT02014441|E1|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
34535|NCT02014363|B4|Baseline|Total|Total of all reporting groups
34536|NCT02014363|B3|Baseline|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
34537|NCT02014363|B2|Baseline|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
34538|NCT02014363|B1|Baseline|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
34539|NCT02014363|P3|Participant Flow|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
34540|NCT02014363|P2|Participant Flow|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
34541|NCT02014363|P1|Participant Flow|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
34542|NCT02014363|O3|Outcome|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
34543|NCT02014363|O2|Outcome|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
34628|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34544|NCT02014363|O1|Outcome|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
34545|NCT02014363|E3|Reported Event|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
34546|NCT02014363|E2|Reported Event|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
34547|NCT02014363|E1|Reported Event|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
34548|NCT02014272|B1|Baseline|Entire Study Population|Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
34549|NCT02014272|P2|Participant Flow|Rifampicin and Isoniazid First, Then RIN 150|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
34550|NCT02014272|P1|Participant Flow|RIN 150 First, Then Rifampicin and Isoniazid|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
34551|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34552|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34553|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34554|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34555|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34556|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34557|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34558|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34559|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34560|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34561|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34562|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34563|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34564|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34565|NCT02014272|E2|Reported Event|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
34566|NCT02014272|E1|Reported Event|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
34567|NCT02014051|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
34568|NCT02014051|P2|Participant Flow|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34569|NCT02014051|P1|Participant Flow|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34570|NCT02014051|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
34571|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34572|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34573|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34574|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34575|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34576|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34577|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34578|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34579|NCT02014051|E2|Reported Event|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34580|NCT02014051|E1|Reported Event|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
34581|NCT02013830|B1|Baseline|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34582|NCT02013830|P1|Participant Flow|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34583|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34584|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34585|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34586|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34629|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34630|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34587|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34588|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34589|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34590|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34591|NCT02013830|E1|Reported Event|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
34592|NCT02013817|B1|Baseline|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34593|NCT02013817|P1|Participant Flow|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34594|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34595|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34596|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34631|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34632|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34633|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34634|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34635|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34597|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34598|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34599|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34600|NCT02013817|E1|Reported Event|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
34601|NCT02013765|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34602|NCT02013765|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34603|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34604|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34605|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34606|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34607|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34608|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34609|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34610|NCT02013765|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
34611|NCT02013687|B5|Baseline|Total|Total of all reporting groups
34612|NCT02013687|B4|Baseline|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34613|NCT02013687|B3|Baseline|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34614|NCT02013687|B2|Baseline|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34615|NCT02013687|B1|Baseline|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34616|NCT02013687|P4|Participant Flow|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34617|NCT02013687|P3|Participant Flow|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34618|NCT02013687|P2|Participant Flow|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34619|NCT02013687|P1|Participant Flow|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
34620|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34621|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34622|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34623|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34624|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
34648|NCT02013622|B1|Baseline|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34649|NCT02013622|P1|Participant Flow|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
34650|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34651|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34652|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34653|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34654|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34655|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34656|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34657|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34658|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34659|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34660|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34661|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34662|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34663|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34664|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34665|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34666|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34667|NCT02013622|E1|Reported Event|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
34668|NCT02013609|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34669|NCT02013609|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
34670|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34671|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34672|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34673|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34674|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34675|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34676|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34677|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34678|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34679|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34680|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34681|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34682|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34683|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34684|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34685|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34724|NCT02013388|P6|Participant Flow|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
34686|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34687|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34688|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34689|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34690|NCT02013609|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
34691|NCT02013531|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34692|NCT02013531|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
34693|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34694|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34695|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34696|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34697|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34698|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34699|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34700|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34701|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34702|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34703|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34704|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34705|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34706|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34707|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34708|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34709|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34710|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34711|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
34712|NCT02013531|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
34713|NCT02013388|B9|Baseline|Total|Total of all reporting groups
34714|NCT02013388|B8|Baseline|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
34715|NCT02013388|B7|Baseline|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
34716|NCT02013388|B6|Baseline|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
34717|NCT02013388|B5|Baseline|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34718|NCT02013388|B4|Baseline|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34719|NCT02013388|B3|Baseline|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34720|NCT02013388|B2|Baseline|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34721|NCT02013388|B1|Baseline|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
34722|NCT02013388|P8|Participant Flow|Placebo-single Dose|Placebo: Given PO daily for 1 day
34723|NCT02013388|P7|Participant Flow|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
34725|NCT02013388|P5|Participant Flow|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34726|NCT02013388|P4|Participant Flow|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34727|NCT02013388|P3|Participant Flow|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34728|NCT02013388|P2|Participant Flow|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34729|NCT02013388|P1|Participant Flow|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
34730|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34731|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34732|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34733|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34734|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34735|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34736|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34737|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34738|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34739|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34740|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34741|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34742|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34743|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34744|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34745|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34746|NCT02013388|O8|Outcome|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
34747|NCT02013388|O7|Outcome|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
34748|NCT02013388|O6|Outcome|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
34749|NCT02013388|O5|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34750|NCT02013388|O4|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34751|NCT02013388|O3|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34752|NCT02013388|O2|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34753|NCT02013388|O1|Outcome|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
34754|NCT02013388|E8|Reported Event|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
34755|NCT02013388|E7|Reported Event|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
34756|NCT02013388|E6|Reported Event|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
34757|NCT02013388|E5|Reported Event|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34758|NCT02013388|E4|Reported Event|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
34759|NCT02013388|E3|Reported Event|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34760|NCT02013388|E2|Reported Event|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
34761|NCT02013388|E1|Reported Event|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
34762|NCT02013206|B3|Baseline|Total|Total of all reporting groups
34763|NCT02013206|B2|Baseline|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34764|NCT02013206|B1|Baseline|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34765|NCT02013206|P2|Participant Flow|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34766|NCT02013206|P1|Participant Flow|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34767|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34795|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
34796|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34797|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
34768|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34769|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34770|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34771|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34772|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34773|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34774|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34775|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34776|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34777|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34778|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34779|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34780|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34781|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34782|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34783|NCT02013206|E2|Reported Event|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
34784|NCT02013206|E1|Reported Event|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
34785|NCT02012686|B3|Baseline|Total|Total of all reporting groups
34786|NCT02012686|B2|Baseline|TENS Group|numerical rating scale of TENS applied group
34787|NCT02012686|B1|Baseline|Control Group|numerical rating scale of TENS non-applied group
34788|NCT02012686|P2|Participant Flow|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34789|NCT02012686|P1|Participant Flow|Control Group|numerical rating scale of TENS non-applied group
34790|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34791|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
34792|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34793|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
34794|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34798|NCT02012686|E2|Reported Event|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
34799|NCT02012686|E1|Reported Event|Control Group|numerical rating scale of TENS non-applied group
34800|NCT02012582|B5|Baseline|Total|Total of all reporting groups
34801|NCT02012582|B4|Baseline|Placebo|"0.9 % Sodium chloride infusion~Saline"
34802|NCT02012582|B3|Baseline|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34803|NCT02012582|B2|Baseline|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34804|NCT02012582|B1|Baseline|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34805|NCT02012582|P4|Participant Flow|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34806|NCT02012582|P3|Participant Flow|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34807|NCT02012582|P2|Participant Flow|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34808|NCT02012582|P1|Participant Flow|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34809|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34810|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34811|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34812|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34813|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34814|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34815|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34816|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34817|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34818|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34819|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34820|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34821|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34822|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34823|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34824|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34825|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34826|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34827|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34828|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34829|NCT02012582|E4|Reported Event|Placebo|"0.9 % Sodium chloride infusion~Placebo"
34830|NCT02012582|E3|Reported Event|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
34831|NCT02012582|E2|Reported Event|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
34832|NCT02012582|E1|Reported Event|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
34833|NCT02012452|B3|Baseline|Total|Total of all reporting groups
34834|NCT02012452|B2|Baseline|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
34835|NCT02012452|B1|Baseline|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
34836|NCT02012452|P2|Participant Flow|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
34837|NCT02012452|P1|Participant Flow|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
34838|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
34839|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
34840|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
34841|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
76026|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
34842|NCT02012452|E2|Reported Event|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
34843|NCT02012452|E1|Reported Event|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
34844|NCT02012218|B6|Baseline|Total|Total of all reporting groups
34845|NCT02012218|B5|Baseline|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34846|NCT02012218|B4|Baseline|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34847|NCT02012218|B3|Baseline|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34848|NCT02012218|B2|Baseline|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34849|NCT02012218|B1|Baseline|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34850|NCT02012218|P5|Participant Flow|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34851|NCT02012218|P4|Participant Flow|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34852|NCT02012218|P3|Participant Flow|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34853|NCT02012218|P2|Participant Flow|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34854|NCT02012218|P1|Participant Flow|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34855|NCT02012218|O5|Outcome|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34856|NCT02012218|O4|Outcome|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34857|NCT02012218|O3|Outcome|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34858|NCT02012218|O2|Outcome|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34859|NCT02012218|O1|Outcome|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34860|NCT02012218|E5|Reported Event|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34861|NCT02012218|E4|Reported Event|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34862|NCT02012218|E3|Reported Event|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34863|NCT02012218|E2|Reported Event|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34864|NCT02012218|E1|Reported Event|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
34865|NCT02011490|B4|Baseline|Total|Total of all reporting groups
34866|NCT02011490|B3|Baseline|Healthy Control Participants: Part 1 + Part 2|This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
34867|NCT02011490|B2|Baseline|Moderate Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
34868|NCT02011490|B1|Baseline|Severe Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
34869|NCT02011490|P6|Participant Flow|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34870|NCT02011490|P5|Participant Flow|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34871|NCT02011490|P4|Participant Flow|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34872|NCT02011490|P3|Participant Flow|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34873|NCT02011490|P2|Participant Flow|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34874|NCT02011490|P1|Participant Flow|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34875|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34876|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34877|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34878|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34879|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34880|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34881|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34920|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
35756|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
34882|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34883|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34884|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34885|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34886|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34887|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34888|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34889|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34890|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34891|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34892|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34893|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34894|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34895|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34896|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34897|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34898|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34899|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34900|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34901|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34902|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34903|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34904|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34905|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34906|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34907|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34908|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34909|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34910|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34911|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34912|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34913|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34914|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34915|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34916|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34917|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34918|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34919|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34921|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34922|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34923|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34924|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34925|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34926|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34927|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34928|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34929|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34930|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34931|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34932|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34933|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34934|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34935|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34936|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34937|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34938|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34939|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
35693|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
34940|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34941|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34942|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34943|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34944|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34945|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34946|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34947|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34948|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34949|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34950|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34951|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34952|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34953|NCT02011490|E6|Reported Event|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34954|NCT02011490|E5|Reported Event|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34955|NCT02011490|E4|Reported Event|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
34956|NCT02011490|E3|Reported Event|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34957|NCT02011490|E2|Reported Event|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
34958|NCT02011490|E1|Reported Event|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
35694|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
34959|NCT02011113|B1|Baseline|Pomalidomide Plus Dexamethasone|Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
34960|NCT02011113|P1|Participant Flow|Pomalidomide Plus Dexamethasone|Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age
34961|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
34962|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34963|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34964|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34965|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34966|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34967|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34968|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34969|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34970|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34971|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
34972|NCT02011113|E1|Reported Event|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
34973|NCT02010996|B3|Baseline|Total|Total of all reporting groups
34974|NCT02010996|B2|Baseline|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
34975|NCT02010996|B1|Baseline|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
34976|NCT02010996|P2|Participant Flow|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
34977|NCT02010996|P1|Participant Flow|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
34978|NCT02010996|O4|Outcome|Axillary Dissection(Shank)|
34979|NCT02010996|O3|Outcome|Vacuum Assisted Closure(Shank)|
34980|NCT02010996|O2|Outcome|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
34981|NCT02010996|O1|Outcome|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
34982|NCT02010996|E4|Reported Event|Axillary Dissection(Shank)|
34983|NCT02010996|E3|Reported Event|Vacuum Assisted Closure(Shank)|
34984|NCT02010996|E2|Reported Event|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
34985|NCT02010996|E1|Reported Event|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
34986|NCT02010684|B3|Baseline|Total|Total of all reporting groups
34987|NCT02010684|B2|Baseline|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
34988|NCT02010684|B1|Baseline|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
34989|NCT02010684|P2|Participant Flow|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. Then participants will learn a diabetes education format grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.~Empowerment and CBT Classes: Participants will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Modu"
34990|NCT02010684|P1|Participant Flow|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
34991|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
34992|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
35020|NCT02010255|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35695|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
34993|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
34994|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
34995|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
34996|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
34997|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
34998|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
34999|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
35000|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
35001|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
35002|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
35021|NCT02010255|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35022|NCT02010255|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
76027|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
35003|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
35004|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
35005|NCT02010684|E2|Reported Event|Empowerment and CBT Classes|"Weekly 2-hour group Empowerment and CBT classes for 12 weeks are led by two trained health educators. Cognitive behavioral therapy (CBT) techniques to manage mood and diabetes education, grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood, is presented. Group members monitor their blood sugar levels, blood pressure, and mood on a daily basis. The intervention arm participants receive a manual with 3 CBT modules (Understanding Depression and Diabetes, How Thoughts Affect Your Mood and Diabetes Care, andHow Activities Affect Your Mood and Diabetes Care. and 1 Diabetes Empowerment module. covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
35006|NCT02010684|E1|Reported Event|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
35007|NCT02010632|B1|Baseline|All Study Participants|First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
35008|NCT02010632|P2|Participant Flow|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35009|NCT02010632|P1|Participant Flow|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35010|NCT02010632|O2|Outcome|Original Clopidogrel Product|"Plavix® 75mg tablet~Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35011|NCT02010632|O1|Outcome|Generic Clopidogrel Product|"Apolets® 75 mg tablet~Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35012|NCT02010632|E2|Reported Event|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35013|NCT02010632|E1|Reported Event|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
35014|NCT02010255|B15|Baseline|Total|Total of all reporting groups
35015|NCT02010255|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35016|NCT02010255|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35017|NCT02010255|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35018|NCT02010255|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35019|NCT02010255|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35023|NCT02010255|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35024|NCT02010255|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35025|NCT02010255|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35026|NCT02010255|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35027|NCT02010255|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35028|NCT02010255|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35029|NCT02010255|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35030|NCT02010255|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35031|NCT02010255|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35032|NCT02010255|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35033|NCT02010255|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35034|NCT02010255|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35035|NCT02010255|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35036|NCT02010255|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35037|NCT02010255|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35038|NCT02010255|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
35039|NCT02010255|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35040|NCT02010255|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35041|NCT02010255|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35042|NCT02010255|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
35043|NCT02010255|O10|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35044|NCT02010255|O9|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
36035|NCT02004847|O2|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
35045|NCT02010255|O8|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35046|NCT02010255|O7|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35047|NCT02010255|O6|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35048|NCT02010255|O5|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35049|NCT02010255|O4|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35050|NCT02010255|O3|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35051|NCT02010255|O2|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35052|NCT02010255|O1|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
35053|NCT02010255|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35054|NCT02010255|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35055|NCT02010255|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35056|NCT02010255|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35057|NCT02010255|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35058|NCT02010255|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35059|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35060|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35061|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35062|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
35063|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35064|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35065|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35066|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35067|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35696|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
35068|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35069|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35070|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35071|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35072|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35073|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35074|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35075|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35076|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35077|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35078|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35079|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35080|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35081|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35082|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35083|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35084|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35085|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35086|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35087|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35088|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35089|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35090|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35091|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
76028|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
35092|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35093|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35094|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35095|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35096|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35097|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35098|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35099|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35100|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35101|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35102|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35103|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35104|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35105|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35106|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35107|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35108|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35109|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35110|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35111|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35112|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35113|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35114|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35115|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
76029|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
35116|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35117|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35118|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35119|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35120|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35121|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35122|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35123|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35124|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35125|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35126|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35127|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35128|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35129|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35130|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35131|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35132|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35133|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35134|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35135|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35136|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35137|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35138|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35697|NCT02007200|E1|Reported Event|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
35139|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35140|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35141|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35142|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35143|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35144|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35145|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35146|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35147|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35148|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35149|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35150|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35151|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35152|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35153|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35154|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35155|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35156|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35157|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35158|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35159|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35160|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35161|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35162|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
76030|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
35163|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35164|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35165|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35166|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35167|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35168|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35169|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35170|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35171|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35172|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35173|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35174|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35175|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35176|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35177|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35178|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35179|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35180|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35181|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35182|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35183|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35184|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35185|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35186|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35187|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35188|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35189|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35190|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35191|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35192|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35193|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35194|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35195|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35196|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35197|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35198|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35199|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35200|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35201|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35202|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35203|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35204|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35205|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35206|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35207|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35208|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35209|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35210|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
76031|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
35211|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35212|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35213|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35214|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35215|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35216|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35217|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35218|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35219|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35220|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35221|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35222|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35223|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35224|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35225|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35226|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35227|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35228|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35229|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35230|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35231|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35232|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35233|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35234|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
76032|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
35235|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35236|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35237|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35238|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35239|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35240|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35241|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35242|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35243|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35244|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35245|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35246|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35247|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35248|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35249|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35250|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35251|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35252|NCT02010255|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
35253|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35254|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35255|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35256|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35257|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35258|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35259|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35260|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35261|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35262|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35263|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35264|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35265|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35266|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35267|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35268|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35269|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35270|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35271|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35272|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35273|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35274|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35275|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35276|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35277|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35278|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35279|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35280|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35281|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35282|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35757|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35283|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35284|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35285|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35286|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35287|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35288|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35289|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35290|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35291|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35292|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35293|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35294|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35295|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35296|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35297|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35298|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35299|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35300|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35301|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35302|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35303|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35304|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35305|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35329|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35306|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35307|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35308|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35309|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35310|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35311|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35312|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35313|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35314|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35315|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35316|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35317|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35318|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35319|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35320|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35321|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35322|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35323|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35324|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35325|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35326|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35327|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35328|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35380|NCT02009982|E2|Reported Event|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
35330|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35331|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35332|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35333|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35334|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35335|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35336|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35337|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35338|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35339|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35340|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35341|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35342|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35343|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35344|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35345|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35346|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
35347|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35348|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35349|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35350|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35351|NCT02010255|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
35352|NCT02010255|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
35353|NCT02010255|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
76033|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
35354|NCT02010255|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35355|NCT02010255|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35356|NCT02010255|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
35357|NCT02010255|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
35358|NCT02010255|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
35359|NCT02010255|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
35360|NCT02010255|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
35361|NCT02010255|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
35362|NCT02010255|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
35363|NCT02010255|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
35364|NCT02010255|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
35365|NCT02010216|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35366|NCT02010216|P1|Participant Flow|Tocilizumab [RoActemra/Actemra]|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35367|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35368|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35369|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35370|NCT02010216|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
35371|NCT02009982|B3|Baseline|Total|Total of all reporting groups
35372|NCT02009982|B2|Baseline|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
35373|NCT02009982|B1|Baseline|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
35374|NCT02009982|P2|Participant Flow|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
35375|NCT02009982|P1|Participant Flow|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
35376|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
35377|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
35378|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
35379|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
35381|NCT02009982|E1|Reported Event|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
35382|NCT02009878|B4|Baseline|Total|Total of all reporting groups
35383|NCT02009878|B3|Baseline|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35384|NCT02009878|B2|Baseline|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35385|NCT02009878|B1|Baseline|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35386|NCT02009878|P3|Participant Flow|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35387|NCT02009878|P2|Participant Flow|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35388|NCT02009878|P1|Participant Flow|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35389|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35390|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35391|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35392|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35393|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35394|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35395|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35396|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35397|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35398|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35399|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35400|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35401|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35402|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35403|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35404|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35405|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35406|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35407|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35408|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35409|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35410|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35411|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35412|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35413|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
35414|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
35415|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
35416|NCT02009878|E3|Reported Event|Tolvaptan 15 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
35417|NCT02009878|E2|Reported Event|Tolvaptan 7.5 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
35418|NCT02009878|E1|Reported Event|Tolvaptan 3.75 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
35419|NCT02009865|B3|Baseline|Total|Total of all reporting groups
35420|NCT02009865|B2|Baseline|Olive Oil|2g once daily (QD)
35421|NCT02009865|B1|Baseline|Epanova|2g once daily (QD)
35422|NCT02009865|P2|Participant Flow|Olive Oil|2g once daily (QD)
35423|NCT02009865|P1|Participant Flow|Epanova|2g once daily (QD)
35424|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
35425|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
35426|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
35427|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
35428|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
35429|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
35430|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
35431|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
35432|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
35433|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
35434|NCT02009865|E2|Reported Event|Olive Oil|2g once daily (QD)
35435|NCT02009865|E1|Reported Event|Epanova|2g once daily (QD)
35436|NCT02009722|B3|Baseline|Total|Total of all reporting groups
35437|NCT02009722|B2|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35469|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35438|NCT02009722|B1|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35439|NCT02009722|P2|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35440|NCT02009722|P1|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35441|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35442|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35443|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35444|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35445|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35446|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35447|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35448|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35449|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35450|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35451|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
36036|NCT02004847|O1|Outcome|Low Intensity|PSO-CT02 device: Light wavelength 453nm, low intensity
35452|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35453|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35454|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35455|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35456|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35457|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35458|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35459|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35460|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35461|NCT02009722|E2|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
35462|NCT02009722|E1|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
35463|NCT02009696|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35464|NCT02009696|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35465|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35466|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35467|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35468|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35918|NCT02005029|O1|Outcome|Erythromycin|Five times sit-to-stand for all participants receiving erythromycin
35470|NCT02009696|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
35471|NCT02009163|B1|Baseline|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35472|NCT02009163|P3|Participant Flow|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26­week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35473|NCT02009163|P2|Participant Flow|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35474|NCT02009163|P1|Participant Flow|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
35475|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35476|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35477|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35478|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35479|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label phase and who had a post-baseline safety assessment.
35480|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35481|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35482|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35483|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35484|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35485|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35486|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35487|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35488|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35489|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35490|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35491|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35492|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35758|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35493|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35494|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
35495|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35496|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35497|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35498|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35499|NCT02009163|O2|Outcome|SPD489 (Randomized­-Withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70 mg was continued throughout the 26-week double-blind randomized-­withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35500|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35501|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35502|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35503|NCT02009163|E3|Reported Event|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
35504|NCT02009163|E2|Reported Event|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week .
35505|NCT02009163|E1|Reported Event|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
35506|NCT02008942|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug
35507|NCT02008942|P2|Participant Flow|Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin|"First Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
35508|NCT02008942|P1|Participant Flow|PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days"
35509|NCT02008942|O2|Outcome|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
35510|NCT02008942|O1|Outcome|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
35511|NCT02008942|E2|Reported Event|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
35512|NCT02008942|E1|Reported Event|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
35513|NCT02008682|B3|Baseline|Total|Total of all reporting groups
35514|NCT02008682|B2|Baseline|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35515|NCT02008682|B1|Baseline|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35516|NCT02008682|P2|Participant Flow|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35517|NCT02008682|P1|Participant Flow|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35518|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35759|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35519|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35520|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35521|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35522|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35523|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35524|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35525|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35526|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35527|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35528|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35529|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35530|NCT02008682|E2|Reported Event|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
35531|NCT02008682|E1|Reported Event|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
35532|NCT02007863|B1|Baseline|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
35533|NCT02007863|P1|Participant Flow|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
35534|NCT02007863|O1|Outcome|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
35535|NCT02007863|E1|Reported Event|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
35536|NCT02007577|B3|Baseline|Total|Total of all reporting groups
35537|NCT02007577|B2|Baseline|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
35538|NCT02007577|B1|Baseline|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
35539|NCT02007577|P2|Participant Flow|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
35592|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35540|NCT02007577|P1|Participant Flow|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
35541|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
35542|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
35543|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
35544|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
35545|NCT02007577|E2|Reported Event|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
35546|NCT02007577|E1|Reported Event|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
35547|NCT02007434|B9|Baseline|Total|Total of all reporting groups
35548|NCT02007434|B8|Baseline|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35549|NCT02007434|B7|Baseline|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35550|NCT02007434|B6|Baseline|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35551|NCT02007434|B5|Baseline|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35552|NCT02007434|B4|Baseline|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35553|NCT02007434|B3|Baseline|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35554|NCT02007434|B2|Baseline|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35555|NCT02007434|B1|Baseline|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35556|NCT02007434|P8|Participant Flow|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35557|NCT02007434|P7|Participant Flow|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35558|NCT02007434|P6|Participant Flow|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35559|NCT02007434|P5|Participant Flow|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35560|NCT02007434|P4|Participant Flow|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35561|NCT02007434|P3|Participant Flow|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35562|NCT02007434|P2|Participant Flow|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35563|NCT02007434|P1|Participant Flow|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
35564|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35565|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35619|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35566|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35567|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35568|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35569|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35570|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35571|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35572|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35573|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35574|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35575|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35576|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35577|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35578|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35579|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35580|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35581|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35582|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35583|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35584|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35585|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35586|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35587|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35588|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35589|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35590|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35591|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
76034|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
35593|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35594|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35595|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35596|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35597|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35598|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35599|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35600|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35601|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35602|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35603|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35604|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35605|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35606|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35607|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35608|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35609|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35610|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35611|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35612|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35613|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35614|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35615|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35616|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35617|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35618|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35698|NCT02007070|B1|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35620|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35621|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35622|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35623|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35624|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35625|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35626|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35627|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35628|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35629|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35630|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35631|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35632|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35633|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35634|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35635|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35636|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35637|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35638|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35639|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35640|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35641|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35642|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35643|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35644|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35645|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35646|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35647|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35648|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35649|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35650|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35651|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35652|NCT02007434|E8|Reported Event|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35653|NCT02007434|E7|Reported Event|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35654|NCT02007434|E6|Reported Event|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
35655|NCT02007434|E5|Reported Event|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
35656|NCT02007434|E4|Reported Event|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
35657|NCT02007434|E3|Reported Event|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
35658|NCT02007434|E2|Reported Event|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35659|NCT02007434|E1|Reported Event|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
35660|NCT02007369|B4|Baseline|Total|Total of all reporting groups
35661|NCT02007369|B3|Baseline|Control|No intervention
35662|NCT02007369|B2|Baseline|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35663|NCT02007369|B1|Baseline|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35664|NCT02007369|P3|Participant Flow|Control|No intervention
35665|NCT02007369|P2|Participant Flow|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35666|NCT02007369|P1|Participant Flow|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35667|NCT02007369|O3|Outcome|Control|No intervention
35668|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35692|NCT02007200|P1|Participant Flow|Treatment (Soy Isoflavones)|"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.~55 patients were enrolled. 3 of these patients did not receive treatment."
76035|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
35669|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35670|NCT02007369|O3|Outcome|Control|No intervention
35671|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35672|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35673|NCT02007369|O3|Outcome|Control|No intervention
35674|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35675|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35676|NCT02007369|O3|Outcome|Control|No intervention
35677|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35678|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35679|NCT02007369|E3|Reported Event|Control|No intervention
35680|NCT02007369|E2|Reported Event|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
35681|NCT02007369|E1|Reported Event|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
35682|NCT02007252|B3|Baseline|Total|Total of all reporting groups
35683|NCT02007252|B2|Baseline|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
35684|NCT02007252|B1|Baseline|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
35685|NCT02007252|P2|Participant Flow|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
35686|NCT02007252|P1|Participant Flow|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
35687|NCT02007252|O2|Outcome|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
35688|NCT02007252|O1|Outcome|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
35689|NCT02007252|E2|Reported Event|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
35690|NCT02007252|E1|Reported Event|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
35691|NCT02007200|B1|Baseline|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
35760|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35699|NCT02007070|P1|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35700|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35701|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35702|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35703|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35704|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35705|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35706|NCT02007070|E1|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
35707|NCT02006836|B4|Baseline|Total|Total of all reporting groups
35708|NCT02006836|B3|Baseline|Diabetic 2|For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (CSII) for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
35709|NCT02006836|B2|Baseline|Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35710|NCT02006836|B1|Baseline|Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35711|NCT02006836|P3|Participant Flow|Self-Control: Diabetic 2|"For self-control period. Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.~On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank.~On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner)."
35712|NCT02006836|P2|Participant Flow|Case-Control: Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35713|NCT02006836|P1|Participant Flow|Case-Control: Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35714|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
35715|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
35716|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
35717|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
35718|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
35719|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
35754|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35755|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35720|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
35721|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
35722|NCT02006836|O2|Outcome|Healthy|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35723|NCT02006836|O1|Outcome|Diabetic|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
35724|NCT02006836|E4|Reported Event|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
35725|NCT02006836|E3|Reported Event|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
35726|NCT02006836|E2|Reported Event|Healthy|On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period.
35727|NCT02006836|E1|Reported Event|Diabetic|Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period.
35728|NCT02006732|B5|Baseline|Total|Total of all reporting groups
35729|NCT02006732|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35730|NCT02006732|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35731|NCT02006732|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35732|NCT02006732|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35733|NCT02006732|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35734|NCT02006732|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35735|NCT02006732|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35736|NCT02006732|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35737|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35738|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35739|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35740|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35741|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35742|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35743|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35744|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35745|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35746|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35747|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35748|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35749|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35750|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35751|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35752|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35753|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35761|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35762|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35763|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35764|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35765|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35766|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35767|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35768|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35769|NCT02006732|E4|Reported Event|Tiotropium 5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35770|NCT02006732|E3|Reported Event|Tiotropium 2.5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
35771|NCT02006732|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
35772|NCT02006732|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
35773|NCT02006706|B1|Baseline|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
35774|NCT02006706|P1|Participant Flow|Rituximab/Methylprednisolone/Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
35775|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
35776|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
35777|NCT02006706|E1|Reported Event|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
35778|NCT02006667|B1|Baseline|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35779|NCT02006667|P1|Participant Flow|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35780|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35781|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35782|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35783|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35784|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35785|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35786|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35919|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
35920|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
35787|NCT02006667|E1|Reported Event|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
35788|NCT02006407|B1|Baseline|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35789|NCT02006407|P1|Participant Flow|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35790|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35791|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35792|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35793|NCT02006407|E1|Reported Event|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
35794|NCT02005692|B1|Baseline|DynaSense Sensor|All subjects who successfully completed the study.
35795|NCT02005692|P1|Participant Flow|DynaSense Sensor|"All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.~The rate of compliance with prescribed turning protocols was measured using the DynaSense System."
35796|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects who successfully completed the study.
35797|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects enrolled in the study.
35798|NCT02005692|E1|Reported Event|DynaSense Sensor|All subjects enrolled in the study.
35799|NCT02005562|B3|Baseline|Total|Total of all reporting groups
35800|NCT02005562|B2|Baseline|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35801|NCT02005562|B1|Baseline|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35921|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
35922|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
35802|NCT02005562|P2|Participant Flow|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35803|NCT02005562|P1|Participant Flow|Mycophenolate Mofetil, Adapted Dose|Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.
35804|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35805|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35806|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35807|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35808|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35809|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35810|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35811|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35812|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35813|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35923|NCT02005029|O2|Outcome|Placebo|Area under the curve 0-4 hours for plasma levodopa after placebo
35814|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35815|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35816|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35817|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35818|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35819|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35820|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35821|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35822|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35823|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35824|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35825|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35849|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
80039|NCT01700387|B3|Baseline|Total|Total of all reporting groups
35826|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35827|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35828|NCT02005562|E2|Reported Event|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35829|NCT02005562|E1|Reported Event|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
35830|NCT02005549|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35831|NCT02005549|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 950 mg/m^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35832|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35833|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35834|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35835|NCT02005549|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
35836|NCT02005536|B1|Baseline|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35837|NCT02005536|P1|Participant Flow|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35838|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35839|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35840|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35841|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35842|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35843|NCT02005536|E1|Reported Event|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
35844|NCT02005484|B1|Baseline|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35845|NCT02005484|P1|Participant Flow|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35846|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35847|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35848|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35917|NCT02005029|O2|Outcome|Placebo|Five times sit-to-stand for all participants receiving placebo
83978|NCT01679028|O2|Outcome|T89 Group A|150mg T89; Single dose
35850|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35851|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35852|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
35853|NCT02005484|E1|Reported Event|Trastuzumab Monotherapy|Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
35854|NCT02005211|B8|Baseline|Total|Total of all reporting groups
35855|NCT02005211|B7|Baseline|Placebo Part 2|Placebo Part 2 - MAD
35856|NCT02005211|B6|Baseline|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35857|NCT02005211|B5|Baseline|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35858|NCT02005211|B4|Baseline|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35859|NCT02005211|B3|Baseline|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35860|NCT02005211|B2|Baseline|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35861|NCT02005211|B1|Baseline|Placebo Part 1|Placebo Part 1 - SAD
35862|NCT02005211|P7|Participant Flow|Placebo Part 2|Placebo Part 2 - MAD
35863|NCT02005211|P6|Participant Flow|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35864|NCT02005211|P5|Participant Flow|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35865|NCT02005211|P4|Participant Flow|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35866|NCT02005211|P3|Participant Flow|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35867|NCT02005211|P2|Participant Flow|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35868|NCT02005211|P1|Participant Flow|Placebo Part 1|Placebo Part 1 - SAD
35869|NCT02005211|O7|Outcome|Placebo Part2|Placebo Part 2 - MAD
35870|NCT02005211|O6|Outcome|Placebo Part 1|Placebo Part 1 - SAD
35871|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35872|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35873|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35874|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35875|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35876|NCT02005211|O7|Outcome|Placebo Part 2|Placebo Part 2 - MAD
35877|NCT02005211|O6|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35878|NCT02005211|O5|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35879|NCT02005211|O4|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35880|NCT02005211|O3|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35881|NCT02005211|O2|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35882|NCT02005211|O1|Outcome|Placebo Part 1|Placebo Part 1 - SAD
35883|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35884|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35885|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35886|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35887|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35888|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35889|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35890|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35891|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35892|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35893|NCT02005211|E7|Reported Event|Placebo Part 2|Placebo Part 2 - MAD
35894|NCT02005211|E6|Reported Event|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
35895|NCT02005211|E5|Reported Event|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
35896|NCT02005211|E4|Reported Event|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
35897|NCT02005211|E3|Reported Event|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
35898|NCT02005211|E2|Reported Event|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
35899|NCT02005211|E1|Reported Event|Placebo Part 1|Placebo Part 1 - SAD
35900|NCT02005029|B3|Baseline|Total|Total of all reporting groups
35901|NCT02005029|B2|Baseline|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
35902|NCT02005029|B1|Baseline|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
35903|NCT02005029|P2|Participant Flow|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
35904|NCT02005029|P1|Participant Flow|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
35905|NCT02005029|O2|Outcome|Placebo|Cmax of plasma levodopa after placebo
35906|NCT02005029|O1|Outcome|Erythromycin|Cmax of plasma levodopa after erythromycin
35907|NCT02005029|O2|Outcome|Placebo|
35908|NCT02005029|O1|Outcome|Erythromycin|
35909|NCT02005029|O2|Outcome|Placebo|AIMS after receiving placebo
35910|NCT02005029|O1|Outcome|Erythromycin|AIMS after receiving erythromycin
35911|NCT02005029|O2|Outcome|Placebo|TUAG (fast speed) after placebo
35912|NCT02005029|O1|Outcome|Erythromycin|TUAG (fast speed) after erythromycin
35913|NCT02005029|O2|Outcome|Placebo|TUAG (comfortable speed) after placebo
35914|NCT02005029|O1|Outcome|Erythromycin|TUAG (comfortable speed) after erythromycin
35915|NCT02005029|O2|Outcome|Placebo|Mean CGS for all participants receiving placebo
35916|NCT02005029|O1|Outcome|Erythromycin|Mean CGS for all participants receiving erythromycin
83979|NCT01679028|O1|Outcome|Placebo Group A|150 mg placebo; single dose
35924|NCT02005029|O1|Outcome|Erythromycin|Area under the curve 0-4 hours for plasma levodopa after erythromycin
35925|NCT02005029|O2|Outcome|Placebo|Mean gastric emptying time for participants receiving placebo
35926|NCT02005029|O1|Outcome|Erythromycin|Mean gastric emptying time for participants receiving erythromycin
35927|NCT02005029|E2|Reported Event|Placebo|Participants who received a one time dose of placebo
35928|NCT02005029|E1|Reported Event|Erythromycin|Participants who received a one time dose of IV erythromycin
35929|NCT02004990|B1|Baseline|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
35930|NCT02004990|P1|Participant Flow|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
35931|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
35932|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
35933|NCT02004990|E1|Reported Event|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
35934|NCT02004886|B5|Baseline|Total|Total of all reporting groups
35935|NCT02004886|B4|Baseline|Placebo|Placebo
35936|NCT02004886|B3|Baseline|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35937|NCT02004886|B2|Baseline|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35938|NCT02004886|B1|Baseline|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35939|NCT02004886|P4|Participant Flow|Placebo|Placebo
35940|NCT02004886|P3|Participant Flow|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35941|NCT02004886|P2|Participant Flow|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35942|NCT02004886|P1|Participant Flow|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35943|NCT02004886|O4|Outcome|Placebo|Placebo
35944|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35945|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35946|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35947|NCT02004886|O4|Outcome|Placebo|Placebo
35948|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35949|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35950|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35951|NCT02004886|O4|Outcome|Placebo|Placebo
35952|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35953|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35954|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35955|NCT02004886|O4|Outcome|Placebo|Placebo
35956|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35957|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35958|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35959|NCT02004886|O4|Outcome|Placebo|Placebo
35960|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35961|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35962|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35963|NCT02004886|O4|Outcome|Placebo|Placebo
35964|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35965|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35966|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35967|NCT02004886|O4|Outcome|Placebo|Placebo
35968|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35969|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35970|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35971|NCT02004886|O4|Outcome|Placebo|Placebo
35972|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35973|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35974|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35975|NCT02004886|O4|Outcome|Placebo|Placebo
35976|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35977|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35978|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35979|NCT02004886|O4|Outcome|Placebo|Placebo
35980|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35981|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35982|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35983|NCT02004886|O4|Outcome|Placebo|Placebo
35984|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35985|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35986|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35987|NCT02004886|E4|Reported Event|Placebo|Placebo
35988|NCT02004886|E3|Reported Event|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
35989|NCT02004886|E2|Reported Event|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
35990|NCT02004886|E1|Reported Event|MK-0893 (40 mg)|MK-0893 40-mg, once daily
35991|NCT02004873|B1|Baseline|Micra Study Enrollments|All subjects enrolled in the Micra study
83980|NCT01679028|E6|Reported Event|T89 Group C|T89 225mf bid for 14 days
35992|NCT02004873|P1|Participant Flow|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
35993|NCT02004873|O1|Outcome|Micra Subjects With Usable M-PREP Data|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
35994|NCT02004873|O1|Outcome|Micra Subjects With 6-month PCT Data|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
35995|NCT02004873|O1|Outcome|Micra Subjects With Implant and 6-month PCT Data|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
35996|NCT02004873|O1|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
35997|NCT02004873|E1|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
35998|NCT02004847|B3|Baseline|Total|Total of all reporting groups
35999|NCT02004847|B2|Baseline|Low Intensity (LI) vs Control|"PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
36000|NCT02004847|B1|Baseline|High Intensity (HI) vs Control|"PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
36001|NCT02004847|P2|Participant Flow|Low Intensity (LI) vs. Control|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36002|NCT02004847|P1|Participant Flow|High Intensity (HI) vs. Control|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36003|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36004|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36005|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36006|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36007|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36008|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36009|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36010|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36011|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
36012|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
36013|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
36014|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
36015|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36016|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36017|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36018|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36019|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36020|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36021|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36022|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36023|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient
36024|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36025|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
36026|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36027|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
36028|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36029|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
36030|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36031|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
36032|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
36033|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
36034|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
36037|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
36038|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
36039|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
36040|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
36041|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
36042|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
36043|NCT02004847|E2|Reported Event|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
36044|NCT02004847|E1|Reported Event|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
36045|NCT02004236|B4|Baseline|Total|Total of all reporting groups
36046|NCT02004236|B3|Baseline|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36047|NCT02004236|B2|Baseline|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36048|NCT02004236|B1|Baseline|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36049|NCT02004236|P3|Participant Flow|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36050|NCT02004236|P2|Participant Flow|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36051|NCT02004236|P1|Participant Flow|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36052|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36053|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36054|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36055|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36056|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36057|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36058|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36059|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36060|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36061|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36062|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36063|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36064|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36065|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36066|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36067|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36068|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36069|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36070|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36071|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36072|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36073|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36074|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36075|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36076|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36077|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36078|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36079|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36080|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36081|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36082|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36083|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36084|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36085|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36086|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36087|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36088|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36089|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36090|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36091|NCT02004236|E3|Reported Event|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
36092|NCT02004236|E2|Reported Event|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
36093|NCT02004236|E1|Reported Event|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
36094|NCT02004132|B1|Baseline|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36095|NCT02004132|P1|Participant Flow|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36096|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36097|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36098|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36099|NCT02004132|E1|Reported Event|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
36100|NCT02004093|B3|Baseline|Total|Total of all reporting groups
36101|NCT02004093|B2|Baseline|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36102|NCT02004093|B1|Baseline|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36103|NCT02004093|P2|Participant Flow|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36104|NCT02004093|P1|Participant Flow|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36105|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36106|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36107|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36108|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36109|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36110|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36111|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36112|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36113|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36114|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36115|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36116|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36117|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36118|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36119|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36120|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36121|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36149|NCT02003404|O1|Outcome|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
36122|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36123|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36124|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
36125|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36126|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36127|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36128|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36129|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
36130|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
36131|NCT02004093|E2|Reported Event|Chemotherapy|Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
36132|NCT02004093|E1|Reported Event|Chemotherapy + Pertuzumab|Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
36133|NCT02003638|B3|Baseline|Total|Total of all reporting groups
36134|NCT02003638|B2|Baseline|Placebo|Placebo taken orally every day for 12 weeks
36135|NCT02003638|B1|Baseline|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
36136|NCT02003638|P2|Participant Flow|Placebo|Placebo taken orally every day for 12 weeks
36137|NCT02003638|P1|Participant Flow|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
36138|NCT02003638|O2|Outcome|Placebo|Placebo taken orally every day for 12 weeks
36139|NCT02003638|O1|Outcome|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
36140|NCT02003638|E2|Reported Event|Placebo|Placebo taken orally every day for 12 weeks
36141|NCT02003638|E1|Reported Event|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
36142|NCT02003534|B1|Baseline|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
36143|NCT02003534|P1|Participant Flow|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
36144|NCT02003534|O1|Outcome|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
36145|NCT02003534|E1|Reported Event|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
36146|NCT02003404|B1|Baseline|Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
36147|NCT02003404|P1|Participant Flow|Abdominal Skin Barrier Peel Force|"Barrier materials were attached and peeled off control and peristomal abdominal skin.~Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate."
36148|NCT02003404|O2|Outcome|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
36225|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36150|NCT02003404|E2|Reported Event|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
36151|NCT02003404|E1|Reported Event|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
36152|NCT02003391|B3|Baseline|Total|Total of all reporting groups
36153|NCT02003391|B2|Baseline|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
36154|NCT02003391|B1|Baseline|DuoTrav|Travoprost/timolol for 8 weeks
36155|NCT02003391|P2|Participant Flow|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
36156|NCT02003391|P1|Participant Flow|DuoTrav|Travoprost/timolol for 8 weeks
36157|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
36158|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
36159|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
36160|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
36161|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
36162|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
36163|NCT02003391|E2|Reported Event|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
36164|NCT02003391|E1|Reported Event|DuoTrav|Travoprost/timolol for 8 weeks
36165|NCT02003014|B1|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36166|NCT02003014|P1|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36167|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36168|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36169|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36170|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36171|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36172|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36173|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36174|NCT02003014|E1|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
36175|NCT02002936|B1|Baseline|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36176|NCT02002936|P1|Participant Flow|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36177|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36178|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36179|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36180|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36181|NCT02002936|E1|Reported Event|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
36182|NCT02002871|B1|Baseline|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
36226|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
84129|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
36183|NCT02002871|P1|Participant Flow|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
36184|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36185|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36186|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36187|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36188|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36189|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36190|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36191|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36192|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36193|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36194|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36195|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36196|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36197|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36198|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36199|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36200|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36201|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36202|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36203|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36204|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36205|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
36206|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
36207|NCT02002871|E1|Reported Event|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
36208|NCT02002702|B4|Baseline|Total|Total of all reporting groups
36209|NCT02002702|B3|Baseline|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36210|NCT02002702|B2|Baseline|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36211|NCT02002702|B1|Baseline|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36212|NCT02002702|P3|Participant Flow|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36213|NCT02002702|P2|Participant Flow|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36214|NCT02002702|P1|Participant Flow|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36215|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36216|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36217|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36218|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36219|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36220|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36221|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36222|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36223|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36224|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36227|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36228|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36229|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36230|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36231|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36232|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36233|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36234|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36235|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36236|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36237|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36238|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36239|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36240|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36241|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36242|NCT02002702|E3|Reported Event|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
36243|NCT02002702|E2|Reported Event|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
36244|NCT02002702|E1|Reported Event|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
36245|NCT02002689|B1|Baseline|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36246|NCT02002689|P1|Participant Flow|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36247|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36248|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36249|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36250|NCT02002689|E1|Reported Event|LDE225|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
36251|NCT02002650|B3|Baseline|Total|Total of all reporting groups
36252|NCT02002650|B2|Baseline|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
36253|NCT02002650|B1|Baseline|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
36254|NCT02002650|P2|Participant Flow|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
36255|NCT02002650|P1|Participant Flow|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
36256|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin for high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients."
36257|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
36258|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
36259|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
36260|NCT02002650|E2|Reported Event|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
36261|NCT02002650|E1|Reported Event|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
36262|NCT02002221|B3|Baseline|Total|Total of all reporting groups
36263|NCT02002221|B2|Baseline|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36264|NCT02002221|B1|Baseline|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36265|NCT02002221|P2|Participant Flow|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36266|NCT02002221|P1|Participant Flow|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36267|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36268|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36269|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36270|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36271|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36272|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36273|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36274|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36275|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36276|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36277|NCT02002221|E2|Reported Event|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36278|NCT02002221|E1|Reported Event|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
36279|NCT02002208|B3|Baseline|Total|Total of all reporting groups
36280|NCT02002208|B2|Baseline|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
36281|NCT02002208|B1|Baseline|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
36282|NCT02002208|P2|Participant Flow|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
36283|NCT02002208|P1|Participant Flow|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
36284|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
36285|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
36286|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
36287|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
36288|NCT02002208|E2|Reported Event|Placebo Tablets|Orally once a day
36289|NCT02002208|E1|Reported Event|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
36290|NCT02001181|B3|Baseline|Total|Total of all reporting groups
36291|NCT02001181|B2|Baseline|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36292|NCT02001181|B1|Baseline|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36293|NCT02001181|P2|Participant Flow|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36294|NCT02001181|P1|Participant Flow|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36295|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36296|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36297|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36298|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36299|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36300|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36301|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36302|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36303|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36304|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36305|NCT02001181|E2|Reported Event|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
36306|NCT02001181|E1|Reported Event|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
36307|NCT02000973|B5|Baseline|Total|Total of all reporting groups
36308|NCT02000973|B4|Baseline|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
36309|NCT02000973|B3|Baseline|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
36310|NCT02000973|B2|Baseline|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
36311|NCT02000973|B1|Baseline|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
36312|NCT02000973|P4|Participant Flow|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
36313|NCT02000973|P3|Participant Flow|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
36314|NCT02000973|P2|Participant Flow|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
36315|NCT02000973|P1|Participant Flow|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
36316|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
36317|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
36318|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
36319|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
36320|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
36321|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
36322|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
36323|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
36324|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
36325|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
36326|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
36327|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
36328|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
36329|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
36330|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
36331|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
36332|NCT02000973|E4|Reported Event|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
36333|NCT02000973|E3|Reported Event|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
36334|NCT02000973|E2|Reported Event|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
36335|NCT02000973|E1|Reported Event|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
36336|NCT02000752|B3|Baseline|Total|Total of all reporting groups
36337|NCT02000752|B2|Baseline|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36338|NCT02000752|B1|Baseline|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36339|NCT02000752|P2|Participant Flow|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36340|NCT02000752|P1|Participant Flow|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36341|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36342|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36343|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36344|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36345|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36346|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36347|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36348|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36349|NCT02000752|E2|Reported Event|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
36350|NCT02000752|E1|Reported Event|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
36351|NCT02000531|B3|Baseline|Total|Total of all reporting groups
36352|NCT02000531|B2|Baseline|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
36353|NCT02000531|B1|Baseline|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
36354|NCT02000531|P2|Participant Flow|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
36355|NCT02000531|P1|Participant Flow|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
36356|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
36357|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
36358|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
36359|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
36360|NCT02000531|E2|Reported Event|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
36361|NCT02000531|E1|Reported Event|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
36362|NCT01999894|B1|Baseline|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
36363|NCT01999894|P1|Participant Flow|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
36364|NCT01999894|O1|Outcome|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
36365|NCT01999894|E2|Reported Event|Memantine to Memantine|Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
36366|NCT01999894|E1|Reported Event|Placebo to Memantine|Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
36367|NCT01999348|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36368|NCT01999348|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36369|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36370|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36371|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36372|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36373|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36374|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36375|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36376|NCT01999348|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
36377|NCT01999231|B5|Baseline|Total|Total of all reporting groups
36378|NCT01999231|B4|Baseline|20μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
36379|NCT01999231|B3|Baseline|10μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
36380|NCT01999231|B2|Baseline|5μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
36381|NCT01999231|B1|Baseline|1μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
36382|NCT01999231|P4|Participant Flow|20μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes ."
36383|NCT01999231|P3|Participant Flow|10μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups ."
36498|NCT01998880|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36384|NCT01999231|P2|Participant Flow|5μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups ."
36385|NCT01999231|P1|Participant Flow|1μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups ."
36386|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36387|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36388|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36389|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36390|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36391|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36392|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36393|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36394|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36395|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36396|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36397|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36398|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
36399|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36400|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36401|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36402|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36403|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36404|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36405|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36406|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
36407|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36408|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36409|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
36410|NCT01999231|E4|Reported Event|20μg/ml ESAT6-CFP10|There is no adverse event.
36411|NCT01999231|E3|Reported Event|10μg/ml ESAT6-CFP10|There is no adverse event.
36412|NCT01999231|E2|Reported Event|5μg/ml ESAT6-CFP10|"Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .~This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator ."
36426|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36413|NCT01999231|E1|Reported Event|1μg/ml ESAT6-CFP10|"Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .~Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test."
36414|NCT01998919|B3|Baseline|Total|Total of all reporting groups
36415|NCT01998919|B2|Baseline|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36416|NCT01998919|B1|Baseline|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36417|NCT01998919|P2|Participant Flow|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36418|NCT01998919|P1|Participant Flow|Placebo Plus Chemotherapy|Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36419|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36420|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36421|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36422|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36423|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36424|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36425|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
37421|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
36427|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36428|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36429|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36430|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36431|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36432|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36433|NCT01998919|E2|Reported Event|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
36434|NCT01998919|E1|Reported Event|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
36435|NCT01998906|B4|Baseline|Total|Total of all reporting groups
36436|NCT01998906|B3|Baseline|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36437|NCT01998906|B2|Baseline|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36438|NCT01998906|B1|Baseline|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36439|NCT01998906|P3|Participant Flow|HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)|"Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36495|NCT01998880|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
37422|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
36440|NCT01998906|P2|Participant Flow|HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36441|NCT01998906|P1|Participant Flow|HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)|"Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36442|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36443|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36444|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36445|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36446|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36447|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36448|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36449|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36450|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36451|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36805|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36452|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36453|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36454|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36455|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36456|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36457|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36458|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36459|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36460|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36461|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36462|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36463|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
36496|NCT01998880|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36464|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
36465|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36466|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36467|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36468|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36469|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36470|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36471|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36472|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36473|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36474|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36475|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36497|NCT01998880|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36476|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36477|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36478|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36479|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36480|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36481|NCT01998906|E3|Reported Event|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36482|NCT01998906|E2|Reported Event|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
36483|NCT01998906|E1|Reported Event|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
36484|NCT01998893|B1|Baseline|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36485|NCT01998893|P1|Participant Flow|Rituximab|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36486|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36487|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36488|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36489|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36490|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36491|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36492|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36493|NCT01998893|E1|Reported Event|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
36494|NCT01998880|B3|Baseline|Total|Total of all reporting groups
36650|NCT01996709|P1|Participant Flow|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36499|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36500|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36501|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36502|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36503|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36504|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36505|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36506|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36507|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36508|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36509|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36510|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36511|NCT01998880|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
36512|NCT01998880|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
36513|NCT01998581|B3|Baseline|Total|Total of all reporting groups
36514|NCT01998581|B2|Baseline|Restylane-L®|Lips injected with Restylane-L®
36515|NCT01998581|B1|Baseline|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36516|NCT01998581|P2|Participant Flow|Restylane-L®|Lips injected with Restylane-L®
36517|NCT01998581|P1|Participant Flow|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36518|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
36519|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36520|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
36521|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36522|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
36523|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36524|NCT01998581|E2|Reported Event|Restylane-L®|Lips injected with Restylane-L®
36525|NCT01998581|E1|Reported Event|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
36526|NCT01998438|B4|Baseline|Total|Total of all reporting groups
36527|NCT01998438|B3|Baseline|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36528|NCT01998438|B2|Baseline|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36529|NCT01998438|B1|Baseline|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36530|NCT01998438|P3|Participant Flow|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36531|NCT01998438|P2|Participant Flow|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36532|NCT01998438|P1|Participant Flow|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36651|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36533|NCT01998438|O3|Outcome|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36534|NCT01998438|O2|Outcome|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36535|NCT01998438|O1|Outcome|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36536|NCT01998438|E3|Reported Event|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36537|NCT01998438|E2|Reported Event|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36538|NCT01998438|E1|Reported Event|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
36539|NCT01998399|B3|Baseline|Total|Total of all reporting groups
36540|NCT01998399|B2|Baseline|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
36541|NCT01998399|B1|Baseline|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
36542|NCT01998399|P2|Participant Flow|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
36543|NCT01998399|P1|Participant Flow|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
36544|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
36545|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
36546|NCT01998399|E2|Reported Event|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
36547|NCT01998399|E1|Reported Event|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
36548|NCT01998360|B3|Baseline|Total|Total of all reporting groups
36549|NCT01998360|B2|Baseline|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36550|NCT01998360|B1|Baseline|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36551|NCT01998360|P2|Participant Flow|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36552|NCT01998360|P1|Participant Flow|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36553|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36554|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36555|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36556|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36557|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36558|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36559|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36560|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36652|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36653|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36561|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36562|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36563|NCT01998360|E2|Reported Event|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
36564|NCT01998360|E1|Reported Event|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
36565|NCT01998269|B1|Baseline|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a scale.
36566|NCT01998269|P1|Participant Flow|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
36567|NCT01998269|O1|Outcome|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
36568|NCT01998269|E1|Reported Event|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a medication self-management scale.
36569|NCT01997905|B1|Baseline|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36570|NCT01997905|P1|Participant Flow|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36571|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36572|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36573|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36574|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36575|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36576|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36577|NCT01997905|E1|Reported Event|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
36578|NCT01997892|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
36579|NCT01997892|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa.
36580|NCT01997892|O2|Outcome|Excursions > 12.0 g/dL|Hemoglobin excursions above 12.0 g/dL
36581|NCT01997892|O1|Outcome|Excursions <10.0 g/dL|Hemoglobin excursions below 10.0 g/dL
36582|NCT01997892|O2|Outcome|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
36583|NCT01997892|O1|Outcome|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
36584|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
36585|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
36586|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
36587|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
36588|NCT01997892|E2|Reported Event|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
36589|NCT01997892|E1|Reported Event|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
36590|NCT01997723|B1|Baseline|OSA Testing|"Cross-over design, single group/arm~Interventions:~One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring"
36591|NCT01997723|P1|Participant Flow|Experimental|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
36592|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
36593|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
36594|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
36595|NCT01997723|E1|Reported Event|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
36596|NCT01997567|B3|Baseline|Total|Total of all reporting groups
36654|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36597|NCT01997567|B2|Baseline|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
36598|NCT01997567|B1|Baseline|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
36599|NCT01997567|P2|Participant Flow|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
36600|NCT01997567|P1|Participant Flow|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
36601|NCT01997567|O2|Outcome|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
36602|NCT01997567|O1|Outcome|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
36603|NCT01997567|E2|Reported Event|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
36604|NCT01997567|E1|Reported Event|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
36605|NCT01997437|B1|Baseline|Tissue-engineered Airway Transplantation|"Stem-cell seeded bioartificial tracheal scaffold~Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ"
36606|NCT01997437|P1|Participant Flow|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36607|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36608|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36609|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36610|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36611|NCT01997437|E1|Reported Event|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
36612|NCT01997398|B1|Baseline|DBS Under General Anesthesia|Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
36613|NCT01997398|P1|Participant Flow|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
36614|NCT01997398|O2|Outcome|Post - DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
36615|NCT01997398|O1|Outcome|Pre-DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
36616|NCT01997398|O4|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
36617|NCT01997398|O3|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
36618|NCT01997398|O2|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
36619|NCT01997398|O1|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off  medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.~Off medication ."
36620|NCT01997398|E1|Reported Event|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
36621|NCT01997216|B1|Baseline|Overall|Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
36622|NCT01997216|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
36623|NCT01997216|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
36624|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36625|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36626|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36627|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36628|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36629|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36630|NCT01997216|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36631|NCT01997216|E1|Reported Event|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
36632|NCT01996904|B3|Baseline|Total|Total of all reporting groups
36633|NCT01996904|B2|Baseline|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
36655|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36656|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36657|NCT01996709|O4|Outcome|Habitual MPS, Left Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
36658|NCT01996709|O3|Outcome|Habitual MPS, Right Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
36634|NCT01996904|B1|Baseline|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
36635|NCT01996904|P2|Participant Flow|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
36636|NCT01996904|P1|Participant Flow|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
36637|NCT01996904|O2|Outcome|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
36638|NCT01996904|O1|Outcome|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
36639|NCT01996904|E2|Reported Event|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
36640|NCT01996904|E1|Reported Event|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
36641|NCT01996813|B1|Baseline|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
36642|NCT01996813|P1|Participant Flow|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
36643|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
36644|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
36645|NCT01996813|E1|Reported Event|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
36646|NCT01996709|B3|Baseline|Total|Total of all reporting groups
36647|NCT01996709|B2|Baseline|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36648|NCT01996709|B1|Baseline|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36649|NCT01996709|P2|Participant Flow|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36659|NCT01996709|O2|Outcome|Clear Care, Left Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36660|NCT01996709|O1|Outcome|Clear Care, Right Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36661|NCT01996709|E2|Reported Event|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
36662|NCT01996709|E1|Reported Event|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
36663|NCT01996410|B9|Baseline|Total|Total of all reporting groups
36664|NCT01996410|B8|Baseline|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36665|NCT01996410|B7|Baseline|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36666|NCT01996410|B6|Baseline|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36667|NCT01996410|B5|Baseline|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36668|NCT01996410|B4|Baseline|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36669|NCT01996410|B3|Baseline|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36670|NCT01996410|B2|Baseline|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36671|NCT01996410|B1|Baseline|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36672|NCT01996410|P8|Participant Flow|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36673|NCT01996410|P7|Participant Flow|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36739|NCT01995357|O4|Outcome|Colostomy, Training + Test B|
36740|NCT01995357|O3|Outcome|Colostomy, Test B|
36741|NCT01995357|O2|Outcome|Colostomy, Training + Test A|
36742|NCT01995357|O1|Outcome|Colostomy ,Test A|
37423|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
36674|NCT01996410|P6|Participant Flow|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36675|NCT01996410|P5|Participant Flow|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36676|NCT01996410|P4|Participant Flow|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36677|NCT01996410|P3|Participant Flow|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36678|NCT01996410|P2|Participant Flow|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36679|NCT01996410|P1|Participant Flow|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36680|NCT01996410|O2|Outcome|Standard of Care- No Acupuncture|
36681|NCT01996410|O1|Outcome|Acupuncture|
36682|NCT01996410|E8|Reported Event|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36683|NCT01996410|E7|Reported Event|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36684|NCT01996410|E6|Reported Event|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36685|NCT01996410|E5|Reported Event|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36686|NCT01996410|E4|Reported Event|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
37424|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
36687|NCT01996410|E3|Reported Event|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36688|NCT01996410|E2|Reported Event|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36689|NCT01996410|E1|Reported Event|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
36690|NCT01996332|B1|Baseline|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
36691|NCT01996332|P1|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
36692|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
36693|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
36694|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
36695|NCT01996332|E1|Reported Event|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
36696|NCT01996319|B3|Baseline|Total|Total of all reporting groups
36697|NCT01996319|B2|Baseline|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
36698|NCT01996319|B1|Baseline|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
36699|NCT01996319|P2|Participant Flow|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
36700|NCT01996319|P1|Participant Flow|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
36701|NCT01996319|O2|Outcome|Placebo|
36702|NCT01996319|O1|Outcome|QVA149|
36703|NCT01996319|O2|Outcome|Placebo|
36704|NCT01996319|O1|Outcome|QVA149|
36705|NCT01996319|O2|Outcome|Placebo|
36706|NCT01996319|O1|Outcome|QVA149|
36707|NCT01996319|O2|Outcome|Placebo|
36708|NCT01996319|O1|Outcome|QVA149|
36709|NCT01996319|O2|Outcome|Placebo|
36710|NCT01996319|O1|Outcome|QVA149|
36711|NCT01996319|O2|Outcome|Placebo|
36712|NCT01996319|O1|Outcome|QVA149|
36713|NCT01996319|O2|Outcome|Placebo|
36714|NCT01996319|O1|Outcome|QVA149|
36715|NCT01996319|O2|Outcome|Placebo|
36716|NCT01996319|O1|Outcome|QVA149|
36717|NCT01996319|E2|Reported Event|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
36718|NCT01996319|E1|Reported Event|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
36719|NCT01995461|B1|Baseline|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36720|NCT01995461|P1|Participant Flow|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36721|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36743|NCT01995357|E3|Reported Event|Standard Care|Standard care was used only during part one of the study. i.e. for one period only.
36806|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
37425|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
36722|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36723|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36724|NCT01995461|E1|Reported Event|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
36725|NCT01995357|B1|Baseline|All Subjects|Baseline data is summarized for all subjects
36726|NCT01995357|P6|Participant Flow|First Standard Product, Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36727|NCT01995357|P5|Participant Flow|First Standard Product; Then Coloplast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36728|NCT01995357|P4|Participant Flow|First Coloplast Test B; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36729|NCT01995357|P3|Participant Flow|First Coloplast Test B; Then Colopast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36730|NCT01995357|P2|Participant Flow|First Coloplast Test A; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36731|NCT01995357|P1|Participant Flow|First Coloplast Teast A; Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
36732|NCT01995357|O11|Outcome|Ileostomy, Standard Care (SenSura)|
36733|NCT01995357|O10|Outcome|Ileostomy, Training + Test B|
36734|NCT01995357|O9|Outcome|Ileostomy, Test B|
36735|NCT01995357|O8|Outcome|Ileostomy, Training + Test A|
36736|NCT01995357|O7|Outcome|Ileostomy, Test A|
36737|NCT01995357|O6|Outcome|Colostomy, Standard Care (SenSura)|
36738|NCT01995357|O5|Outcome|Colostomy, Standard Care (SenSura Mio)|
36744|NCT01995357|E2|Reported Event|Test B + Training Test B|"Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.~Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one."
36745|NCT01995357|E1|Reported Event|Test A + Training Test A|"Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.~Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one."
36746|NCT01995136|B1|Baseline|TRAVATAN Z|Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
36747|NCT01995136|P1|Participant Flow|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
36748|NCT01995136|O1|Outcome|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
36749|NCT01995136|E1|Reported Event|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
36750|NCT01995045|B3|Baseline|Total|Total of all reporting groups
36751|NCT01995045|B2|Baseline|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36752|NCT01995045|B1|Baseline|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36753|NCT01995045|P2|Participant Flow|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36754|NCT01995045|P1|Participant Flow|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36755|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36756|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36757|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36758|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36759|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36760|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36761|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
36762|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
36763|NCT01995045|E2|Reported Event|Bupivicaine|"Retrobulbar anesthesia with Bupivicaine Hydrochloride~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
36764|NCT01995045|E1|Reported Event|Bupivicaine & Triamcinolone|"Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide~Triamcinolone: Retrobulbar anesthesia~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
36765|NCT01994902|B1|Baseline|Overall Study|The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
36766|NCT01994902|P2|Participant Flow|First SenSura Convex Light; Then Coloplast Test Product|"The subjects test:~test period 1: SenSura Convex Light test period 2: Coloplast test product"
36767|NCT01994902|P1|Participant Flow|First Coloplast Test Product; Then SenSura Convex Light|"The subjects test:~test period 1: Coloplast test product test period 2: SenSura Convex Light"
36768|NCT01994902|O2|Outcome|SenSura Convex Light|The leakage results obtained while subjects were testing SenSura Convex Light
36769|NCT01994902|O1|Outcome|Coloplast Test Product|Leakage results obtained while subjects tested the Coloplast test product
36770|NCT01994902|E2|Reported Event|SenSura Convex Light|Adverse events reported by subjects testing SenSura Convex Light
36771|NCT01994902|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
36772|NCT01994876|B1|Baseline|Overall Study|All the subjects in one group
36803|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36804|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36773|NCT01994876|P2|Participant Flow|First Coloplast Test 2, Then Coloplast Test 1|"The subjects first test their own product to collect baseline measurements~The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
36774|NCT01994876|P1|Participant Flow|First Coloplast Test 1, Then Coloplast Test 2|"The subjects first test their own product to collect a baseline measurement~The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
36775|NCT01994876|O3|Outcome|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
36776|NCT01994876|O2|Outcome|Coloplast Test 2|Results from subjects testing Coloplast Test 2
36777|NCT01994876|O1|Outcome|Coloplast Test 1|Results from subjects testing Coloplast Test 1
36778|NCT01994876|E3|Reported Event|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
36779|NCT01994876|E2|Reported Event|Coloplast Test 2|Results from subjects testing Coloplast Test 2
36780|NCT01994876|E1|Reported Event|Coloplast Test 1|Results from subjects testing Coloplast Test 1
36781|NCT01994863|B1|Baseline|All Subjects|
36782|NCT01994863|P2|Participant Flow|First Standard Care (See Below); Then Coloplast Test Product|"The subjects are randomised to test Standard care first and thereafter test Coloplast test product.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
36783|NCT01994863|P1|Participant Flow|First Coloplast Test Product; Then Standard Care (See Below)|"The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
36784|NCT01994863|O2|Outcome|Standard Care|
36785|NCT01994863|O1|Outcome|Coloplast Test Product|
36786|NCT01994863|E2|Reported Event|Standard Care|
36787|NCT01994863|E1|Reported Event|Coloplast Test Product|
36788|NCT01994746|B1|Baseline|All Study Participants|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At another visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~The order of the visits was randomized."
36789|NCT01994746|P2|Participant Flow|Intramuscular Glucagon 1st/Intranasal Glucagon 2nd|"At the first visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~At the second visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
36790|NCT01994746|P1|Participant Flow|Intranasal Glucagon 1st/Intramuscular Glucagon 2nd|"At the first visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm."
36791|NCT01994746|O2|Outcome|Intramuscular Glucagon|"At a separate visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~Intramuscular Glucagon"
36792|NCT01994746|O1|Outcome|Intranasal Glucagon|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~Intranasal Glucagon"
36793|NCT01994746|E2|Reported Event|Intramuscular Glucagon|1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
36794|NCT01994746|E1|Reported Event|Intranasal Glucagon|A glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
36795|NCT01994629|B3|Baseline|Total|Total of all reporting groups
36796|NCT01994629|B2|Baseline|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36797|NCT01994629|B1|Baseline|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36798|NCT01994629|P2|Participant Flow|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
36799|NCT01994629|P1|Participant Flow|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.
36800|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36801|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36802|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
37426|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
36807|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36808|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36809|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36810|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36811|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36812|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36813|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36814|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36815|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36816|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36817|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36818|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36819|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36820|NCT01994629|E2|Reported Event|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
36821|NCT01994629|E1|Reported Event|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
36822|NCT01994486|B1|Baseline|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
36823|NCT01994486|P1|Participant Flow|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
36824|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
36825|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
36826|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
36827|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
36828|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
36829|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
36830|NCT01994486|E1|Reported Event|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
36831|NCT01994291|B4|Baseline|Total|Total of all reporting groups
36832|NCT01994291|B3|Baseline|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36833|NCT01994291|B2|Baseline|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36834|NCT01994291|B1|Baseline|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36835|NCT01994291|P3|Participant Flow|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36836|NCT01994291|P2|Participant Flow|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36837|NCT01994291|P1|Participant Flow|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36838|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36839|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36840|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36841|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36842|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36843|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36844|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36845|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36846|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36847|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36848|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36849|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36850|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36851|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36852|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36853|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36854|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36855|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36856|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36857|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36858|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36859|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36860|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36861|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36862|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36863|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36864|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36865|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36866|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36867|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36868|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36869|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36870|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36871|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36872|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36873|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36874|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36875|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36876|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36877|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36878|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36879|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36880|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36881|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36882|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36883|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
36884|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36885|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36886|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36887|NCT01994291|E3|Reported Event|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
36888|NCT01994291|E2|Reported Event|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
36889|NCT01994291|E1|Reported Event|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
36890|NCT01993888|B3|Baseline|Total|Total of all reporting groups
36915|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
37184|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
36891|NCT01993888|B2|Baseline|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
36892|NCT01993888|B1|Baseline|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
36893|NCT01993888|P2|Participant Flow|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
36894|NCT01993888|P1|Participant Flow|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
36895|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36896|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36897|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36898|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36899|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36900|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36901|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36902|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36903|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36904|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36905|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36906|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36907|NCT01993888|E2|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
36908|NCT01993888|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
36909|NCT01993823|B3|Baseline|Total|Total of all reporting groups
36910|NCT01993823|B2|Baseline|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
36911|NCT01993823|B1|Baseline|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
36912|NCT01993823|P2|Participant Flow|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
36913|NCT01993823|P1|Participant Flow|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
36914|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
36916|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
36917|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
36918|NCT01993823|E2|Reported Event|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
36919|NCT01993823|E1|Reported Event|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
36920|NCT01993238|B1|Baseline|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
36921|NCT01993238|P1|Participant Flow|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
36922|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
36923|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
36924|NCT01993238|E1|Reported Event|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
36925|NCT01993030|B3|Baseline|Total|Total of all reporting groups
36926|NCT01993030|B2|Baseline|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36927|NCT01993030|B1|Baseline|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36928|NCT01993030|P2|Participant Flow|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36929|NCT01993030|P1|Participant Flow|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36930|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36931|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36932|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36933|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36934|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36935|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36936|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36937|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36938|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36939|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36940|NCT01993030|E2|Reported Event|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
36941|NCT01993030|E1|Reported Event|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
36942|NCT01992874|B1|Baseline|Entire Study Population|It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
36943|NCT01992874|P3|Participant Flow|Part B:Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36944|NCT01992874|P2|Participant Flow|Part A: Pimasertib Tablet Then Pimasertib Capsule|A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
36945|NCT01992874|P1|Participant Flow|Part A: Pimasertib Capsule Then Pimasertib Tablet|A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
36946|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36947|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36948|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36949|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36950|NCT01992874|O3|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36951|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36952|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36953|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36954|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36955|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36956|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36957|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36958|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36959|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36960|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36961|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36962|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36963|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36964|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36965|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36966|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study
36967|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36968|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36969|NCT01992874|E3|Reported Event|Part B: Pimasertib Capsule (BID)|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
36970|NCT01992874|E2|Reported Event|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
36971|NCT01992874|E1|Reported Event|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
36972|NCT01992536|B11|Baseline|Total|Total of all reporting groups
36973|NCT01992536|B10|Baseline|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
36974|NCT01992536|B9|Baseline|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
36975|NCT01992536|B8|Baseline|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
36976|NCT01992536|B7|Baseline|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
36977|NCT01992536|B6|Baseline|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
36978|NCT01992536|B5|Baseline|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
36979|NCT01992536|B4|Baseline|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37182|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
36980|NCT01992536|B3|Baseline|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
36981|NCT01992536|B2|Baseline|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
36982|NCT01992536|B1|Baseline|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
36983|NCT01992536|P10|Participant Flow|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
36984|NCT01992536|P9|Participant Flow|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
36985|NCT01992536|P8|Participant Flow|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
36986|NCT01992536|P7|Participant Flow|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
36987|NCT01992536|P6|Participant Flow|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
36988|NCT01992536|P5|Participant Flow|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
36989|NCT01992536|P4|Participant Flow|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
36990|NCT01992536|P3|Participant Flow|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
36991|NCT01992536|P2|Participant Flow|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
36992|NCT01992536|P1|Participant Flow|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
36993|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
36994|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
36995|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
36996|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
36997|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
36998|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
36999|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37000|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37001|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37002|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37003|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37004|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37005|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37006|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
37007|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37008|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37009|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37010|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37011|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37012|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37013|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37014|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37015|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37016|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
37017|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37018|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37019|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37020|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37021|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37022|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37023|NCT01992536|O11|Outcome|Total|
37024|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37025|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37026|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37027|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
37028|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37029|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37030|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37031|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37032|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37033|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37034|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37035|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37036|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37037|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37038|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37039|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37040|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37041|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37042|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37043|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37044|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37045|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37046|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37047|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37048|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37049|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37050|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37051|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37052|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37053|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37054|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37055|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37056|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37057|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37058|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37059|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37183|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
37060|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37061|NCT01992536|O6|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37062|NCT01992536|O5|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37063|NCT01992536|O4|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37064|NCT01992536|O3|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37065|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37066|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37067|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37068|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37069|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37070|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37071|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37072|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37073|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37074|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37075|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37076|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37077|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37078|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37079|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37080|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37081|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37082|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37083|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37084|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37085|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37086|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37087|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37088|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37089|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37090|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37091|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37092|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37093|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37094|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37095|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37096|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37097|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37098|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37099|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37100|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37101|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37102|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37103|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37104|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37105|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37106|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37107|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37108|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37109|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37110|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37111|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37112|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37113|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37114|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37115|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37116|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37117|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37118|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37119|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37120|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37121|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37122|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37123|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37124|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37125|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37126|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37127|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37128|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37129|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37130|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37131|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37132|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37133|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37134|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37135|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37136|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37137|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37138|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37139|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37140|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37141|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37142|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37143|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37144|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37145|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37146|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37147|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37148|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37149|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37150|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37151|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37152|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37153|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37154|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37155|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37156|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37157|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37158|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37159|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37160|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37161|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37162|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37163|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37164|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37165|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37166|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37167|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
37168|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37169|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
37170|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
37171|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
37172|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37173|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37174|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37175|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
37176|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
37177|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
37178|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
37179|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
37180|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
37181|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
37185|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
37186|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
37187|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
37188|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
37189|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
37190|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
37191|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37192|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37193|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37194|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37195|NCT01992536|E11|Reported Event|Total|Total
37196|NCT01992536|E10|Reported Event|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
37197|NCT01992536|E9|Reported Event|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37198|NCT01992536|E8|Reported Event|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
37199|NCT01992536|E7|Reported Event|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
37200|NCT01992536|E6|Reported Event|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
37201|NCT01992536|E5|Reported Event|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
37202|NCT01992536|E4|Reported Event|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
37203|NCT01992536|E3|Reported Event|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
37204|NCT01992536|E2|Reported Event|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
37205|NCT01992536|E1|Reported Event|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
37206|NCT01992523|B3|Baseline|Total|Total of all reporting groups
37207|NCT01992523|B2|Baseline|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
37208|NCT01992523|B1|Baseline|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
37209|NCT01992523|P2|Participant Flow|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
37210|NCT01992523|P1|Participant Flow|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
37211|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
37212|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
37248|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37213|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
37214|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
37215|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
37216|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
37217|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|
37218|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|
37219|NCT01992523|E2|Reported Event|Ticagrelor Integral Group|patients taking orally 180 mg ticagrelor integral tablets
37220|NCT01992523|E1|Reported Event|Ticagrelor Mashed Group|patients taking orally 180 mg ticagrelor mashed tablets
37221|NCT01992185|B3|Baseline|Total|Total of all reporting groups
37222|NCT01992185|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37223|NCT01992185|B1|Baseline|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
37224|NCT01992185|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37225|NCT01992185|P1|Participant Flow|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
37226|NCT01992185|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37227|NCT01992185|O1|Outcome|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
37228|NCT01992185|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37229|NCT01992185|E1|Reported Event|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
37230|NCT01992172|B3|Baseline|Total|Total of all reporting groups
37231|NCT01992172|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37232|NCT01992172|B1|Baseline|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
37233|NCT01992172|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37234|NCT01992172|P1|Participant Flow|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
37235|NCT01992172|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37236|NCT01992172|O1|Outcome|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
37237|NCT01992172|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
37238|NCT01992172|E1|Reported Event|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
37239|NCT01992107|B4|Baseline|Total|Total of all reporting groups
37240|NCT01992107|B3|Baseline|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37241|NCT01992107|B2|Baseline|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37242|NCT01992107|B1|Baseline|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37243|NCT01992107|P3|Participant Flow|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37244|NCT01992107|P2|Participant Flow|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37245|NCT01992107|P1|Participant Flow|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37246|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37247|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37418|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
37249|NCT01992107|O15|Outcome|TIV2c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37250|NCT01992107|O14|Outcome|TIV1c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37251|NCT01992107|O13|Outcome|QIVc (≥9 to <18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37252|NCT01992107|O12|Outcome|TIV2c _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37253|NCT01992107|O11|Outcome|TIV1c_Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37254|NCT01992107|O10|Outcome|QIVc _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37255|NCT01992107|O9|Outcome|TIV2c _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37256|NCT01992107|O8|Outcome|TIV1c_First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season
37257|NCT01992107|O7|Outcome|QIVc _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37258|NCT01992107|O6|Outcome|TIV2c _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37259|NCT01992107|O5|Outcome|TIV1c_Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37260|NCT01992107|O4|Outcome|QIVc _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37261|NCT01992107|O3|Outcome|TIV2c _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37262|NCT01992107|O2|Outcome|TIV1c_First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37263|NCT01992107|O1|Outcome|QIVc _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37264|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37265|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37266|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37267|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37268|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37269|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37270|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37271|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37272|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37273|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37274|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37275|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37276|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37277|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37278|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37279|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37280|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37281|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37282|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37283|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37284|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37285|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37286|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37287|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37288|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37289|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37290|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37291|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37292|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37293|NCT01992107|E4|Reported Event|Total|Total number of Subjects
37294|NCT01992107|E3|Reported Event|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37295|NCT01992107|E2|Reported Event|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37296|NCT01992107|E1|Reported Event|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
37297|NCT01992094|B4|Baseline|Total|Total of all reporting groups
37298|NCT01992094|B3|Baseline|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37299|NCT01992094|B2|Baseline|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
37300|NCT01992094|B1|Baseline|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37301|NCT01992094|P3|Participant Flow|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37302|NCT01992094|P2|Participant Flow|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
37303|NCT01992094|P1|Participant Flow|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37304|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37305|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37306|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37307|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37308|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37309|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37310|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37311|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37312|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37313|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37314|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37315|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37316|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37317|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37318|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37319|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37320|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37321|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37322|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37323|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37324|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37325|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37326|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37327|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37328|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37329|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37330|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37331|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37332|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37333|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
37334|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37335|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37336|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37337|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37338|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
37339|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
37340|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37341|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37342|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37343|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37344|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
37345|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season
37346|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37347|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37348|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37349|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37350|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37351|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37352|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37353|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37354|NCT01992094|E4|Reported Event|Total|Total Number of Subjects
37355|NCT01992094|E3|Reported Event|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
37356|NCT01992094|E2|Reported Event|TIV1c (≥ 18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
37357|NCT01992094|E1|Reported Event|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
37358|NCT01991990|B3|Baseline|Total|Total of all reporting groups
37359|NCT01991990|B2|Baseline|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
37360|NCT01991990|B1|Baseline|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37361|NCT01991990|P2|Participant Flow|Tocilizumab|Participants received a single dose of intravenous (IV) tocilizumab (TCZ) at a dose of 8 milligrams (mg) per kilogram (kg) body weight infusion over 1 hour on Day 0.
37362|NCT01991990|P1|Participant Flow|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37363|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37419|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
37364|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37365|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37366|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37367|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37368|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37369|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37370|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37371|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37372|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37373|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37374|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37375|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37376|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37377|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37378|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37379|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37380|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37381|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37382|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37383|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37384|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37385|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37386|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37387|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37388|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37389|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37390|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37391|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37392|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37393|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37394|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37395|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37420|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
84131|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
37396|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with greater than (>) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37397|NCT01991990|O2|Outcome|Tocilizumab (Polymorphonuclear Leukocyte (PMN)]-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with less than or equal to (≤) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
37398|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37399|NCT01991990|E2|Reported Event|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
37400|NCT01991990|E1|Reported Event|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
37401|NCT01990859|B1|Baseline|Ipilimumab|Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
37402|NCT01990859|P1|Participant Flow|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37403|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37404|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37405|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37406|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37407|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37408|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37409|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37410|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37411|NCT01990859|E1|Reported Event|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
37412|NCT01990794|B1|Baseline|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37413|NCT01990794|P1|Participant Flow|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37414|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
37415|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
37416|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
37417|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
37427|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
37428|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
37429|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
37430|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
37431|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
37432|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
37433|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
37434|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
37435|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
37436|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
37437|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
37438|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
37439|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
37440|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
37441|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
37442|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
37443|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
37444|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
37445|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
37446|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select RNFL variables
37447|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select RNFL variables
37448|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select RNFL variables
37449|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select RNFL variables
37450|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select RNFL variables
37451|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select RNFL variables
37452|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37453|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37454|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37455|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37456|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37457|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37458|NCT01990794|O2|Outcome|Male Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37459|NCT01990794|O1|Outcome|Female Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37460|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
37461|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
37462|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
37463|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
37464|NCT01990794|O2|Outcome|Male Glucose|Glucose levels before, during, and after dosing
37465|NCT01990794|O1|Outcome|Female Glucose|Glucose levels before, during and after dosing
37466|NCT01990794|O2|Outcome|Male Triglycerides|Triglyceride levels before and after cobalt supplementation
37467|NCT01990794|O1|Outcome|Female Triglycerides|Triglyceride levels before and after cobalt supplementation
37468|NCT01990794|O2|Outcome|Male Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
37469|NCT01990794|O1|Outcome|Female Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
37470|NCT01990794|O2|Outcome|Male HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
37471|NCT01990794|O1|Outcome|Female HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
37472|NCT01990794|O2|Outcome|Male AST|AST levels before, during, and after dosing
37473|NCT01990794|O1|Outcome|Female AST|AST levels before, during and after dosing
37474|NCT01990794|O2|Outcome|Male ALT|ALT levels before, during, and after dosing
37475|NCT01990794|O1|Outcome|Female ALT|ALT levels before, during and after dosing
37476|NCT01990794|O2|Outcome|Male Creatine|Creatine levels before, during, and after dosing
37477|NCT01990794|O1|Outcome|Female Creatine|Creatine levels before, during and after dosing
37478|NCT01990794|O2|Outcome|Male CK-MB|CK-MB levels before, during, and after dosing
37479|NCT01990794|O1|Outcome|Female CK-MB|CK-MB levels before, during and after dosing
37480|NCT01990794|O2|Outcome|Male Ferritin|Ferritin levels before, during, and after dosing
37481|NCT01990794|O1|Outcome|Female Ferritin|Ferritin levels before, during and after dosing
37482|NCT01990794|O2|Outcome|Male Total Iron|Total iron levels before, during, and after dosing
37483|NCT01990794|O1|Outcome|Female Total Iron|Total iron levels before, during and after dosing
37484|NCT01990794|O2|Outcome|Male T4|T4 levels before, during, and after dosing
37485|NCT01990794|O1|Outcome|Female T4|T4 levels before, during and after dosing
37486|NCT01990794|O2|Outcome|Male TSH|TSH levels before, during, and after dosing
37487|NCT01990794|O1|Outcome|Female TSH|TSH levels before, during and after dosing
37488|NCT01990794|O2|Outcome|Male Albumin|Albumin levels before, during, and after dosing
37489|NCT01990794|O1|Outcome|Female Albumin|Albumin levels before, during and after dosing
37490|NCT01990794|O2|Outcome|Male Protein|Protein levels before, during, and after dosing
37491|NCT01990794|O1|Outcome|Female Protein|Protein levels before, during and after dosing
37492|NCT01990794|O2|Outcome|Male Hematocrit|Hematocrit levels before, during, and after dosing
37493|NCT01990794|O1|Outcome|Female Hematocrit|Hematocrit levels before, during and after dosing
37494|NCT01990794|O2|Outcome|Male RBC|RBC levels before, during, and after dosing
37495|NCT01990794|O1|Outcome|Female RBC|RBC levels before, during and after dosing
37496|NCT01990794|O2|Outcome|Male WBC|WBC levels before, during, and after dosing
37497|NCT01990794|O1|Outcome|Female WBC|WBC levels before, during and after dosing
37498|NCT01990794|O2|Outcome|Male|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37499|NCT01990794|O1|Outcome|Female|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37500|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
37501|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
37502|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
37503|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select ONH variables
37504|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select ONH variables
37505|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select ONH variables
37506|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select ONH variables
37507|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select ONH variables
37508|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select ONH variables
37509|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37510|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37511|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
37512|NCT01990794|O6|Outcome|Study Completion - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37513|NCT01990794|O5|Outcome|Study Completion - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37514|NCT01990794|O4|Outcome|Study Midpoint - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37515|NCT01990794|O3|Outcome|Study Midpoint - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37516|NCT01990794|O2|Outcome|Baseline - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37517|NCT01990794|O1|Outcome|Baseline - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
37518|NCT01990794|O2|Outcome|Male Hgb|Hgb levels before, during, and after dosing
37519|NCT01990794|O1|Outcome|Female Hgb|Hgb levels before, during and after dosing
37520|NCT01990794|O2|Outcome|SI After Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
37521|NCT01990794|O1|Outcome|SI Before Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
37522|NCT01990794|O1|Outcome|Albumin-Co Fraction|Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
37523|NCT01990794|E1|Reported Event|Study Volunteers|"Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
37524|NCT01990664|B3|Baseline|Total|Total of all reporting groups
37525|NCT01990664|B2|Baseline|Test (Senofilcon A)|Consists of subjects that were dispensed at least one Test lens.
37526|NCT01990664|B1|Baseline|Control (Senfilcon A)|Consists of subjects that were dispensed at least one Control lens.
37527|NCT01990664|P2|Participant Flow|Test (Senofilcon A)|Subjects that were randomized to receive theTest lens for the duration of the study.
37528|NCT01990664|P1|Participant Flow|Control (Senfilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
37529|NCT01990664|O2|Outcome|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
84185|NCT01677936|E2|Reported Event|Snacks|Snack group
37530|NCT01990664|O1|Outcome|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
37531|NCT01990664|E2|Reported Event|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
37532|NCT01990664|E1|Reported Event|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
37533|NCT01990339|B1|Baseline|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
37534|NCT01990339|P1|Participant Flow|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
37535|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
37536|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
37537|NCT01990339|E1|Reported Event|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
37538|NCT01990261|B1|Baseline|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37539|NCT01990261|P1|Participant Flow|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37540|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37541|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37542|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37543|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37544|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37545|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37546|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37547|NCT01990261|E1|Reported Event|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
37548|NCT01989689|B3|Baseline|Total|Total of all reporting groups
37549|NCT01989689|B2|Baseline|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37550|NCT01989689|B1|Baseline|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37551|NCT01989689|P2|Participant Flow|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37552|NCT01989689|P1|Participant Flow|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37553|NCT01989689|O2|Outcome|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37554|NCT01989689|O1|Outcome|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37555|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37556|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37557|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37558|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37559|NCT01989689|E2|Reported Event|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37560|NCT01989689|E1|Reported Event|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
37561|NCT01989572|B7|Baseline|Total|Total of all reporting groups
37562|NCT01989572|B6|Baseline|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
37563|NCT01989572|B5|Baseline|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
37564|NCT01989572|B4|Baseline|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
37565|NCT01989572|B3|Baseline|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
37566|NCT01989572|B2|Baseline|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
37567|NCT01989572|B1|Baseline|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
37568|NCT01989572|P6|Participant Flow|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
37569|NCT01989572|P5|Participant Flow|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
37570|NCT01989572|P4|Participant Flow|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
37571|NCT01989572|P3|Participant Flow|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
37572|NCT01989572|P2|Participant Flow|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
37573|NCT01989572|P1|Participant Flow|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
37574|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
37575|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
37576|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
37577|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
37578|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
37613|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37614|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
37579|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
37580|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
37581|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
37582|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
37583|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
37584|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
37585|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
37586|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
37587|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
37588|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
37589|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
37590|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
37591|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
37592|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
37593|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
37594|NCT01989572|E6|Reported Event|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
37595|NCT01989572|E5|Reported Event|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
37596|NCT01989572|E4|Reported Event|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC peptide placebo: Given SC"
37597|NCT01989572|E3|Reported Event|Arm III (GM-CSF, Peptide Placebo)|"Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide placebo: Given SC"
37598|NCT01989572|E2|Reported Event|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC GM-CSF placebo: Given SC"
37599|NCT01989572|E1|Reported Event|Arm I (GM-CSF, Peptide Vaccine)|"Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide vaccine: Given SC"
37600|NCT01989455|B6|Baseline|Total|Total of all reporting groups
37601|NCT01989455|B5|Baseline|Placebo|Single intravenous dose of placebo (normal saline solution).
37602|NCT01989455|B4|Baseline|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37603|NCT01989455|B3|Baseline|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37604|NCT01989455|B2|Baseline|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37605|NCT01989455|B1|Baseline|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37606|NCT01989455|P5|Participant Flow|Placebo|Single intravenous dose of placebo (normal saline solution).
37607|NCT01989455|P4|Participant Flow|2000 mg Deferiprone|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37608|NCT01989455|P3|Participant Flow|1500 mg Deferiprone|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37609|NCT01989455|P2|Participant Flow|1000 mg Deferiprone|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
37610|NCT01989455|P1|Participant Flow|500 mg Deferiprone|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37611|NCT01989455|O1|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
37612|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
84186|NCT01677936|E1|Reported Event|Raisin|Raisin group
37615|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37616|NCT01989455|O5|Outcome|Placebo|Single intravenous dose of placebo (normal saline solution).
37617|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37618|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37619|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37620|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37621|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37622|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37623|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37624|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37625|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37626|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37627|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37628|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37629|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37630|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37631|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37632|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37633|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37634|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37635|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37636|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37637|NCT01989455|E6|Reported Event|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
37638|NCT01989455|E5|Reported Event|Placebo|Single intravenous dose of placebo (normal saline solution).
37639|NCT01989455|E4|Reported Event|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37640|NCT01989455|E3|Reported Event|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37641|NCT01989455|E2|Reported Event|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37642|NCT01989455|E1|Reported Event|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
37643|NCT01989195|B1|Baseline|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37644|NCT01989195|P1|Participant Flow|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37645|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37646|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI~Outcome measurement followed for both as all subjects received both MEMRI and DEMRI."
37647|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37648|NCT01989195|O2|Outcome|INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI)|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~MEMRI- SeeMore~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR"
37686|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
37649|NCT01989195|O1|Outcome|DEMRI CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~DEMRI - MAGNEVIST (GADOLINIUM)~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37650|NCT01989195|E1|Reported Event|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI.~- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
37651|NCT01989169|B3|Baseline|Total|Total of all reporting groups
37652|NCT01989169|B2|Baseline|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
37653|NCT01989169|B1|Baseline|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
37654|NCT01989169|P2|Participant Flow|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
37655|NCT01989169|P1|Participant Flow|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
37656|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
37657|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
37658|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
37659|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
37660|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
37661|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
37662|NCT01989169|E2|Reported Event|Midazolam + SSP-004184SS|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
37663|NCT01989169|E1|Reported Event|Midazolam Alone|Administered as a single oral 20 mg dose on Day 1.
37664|NCT01988857|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37665|NCT01988857|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37666|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37667|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37668|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37669|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37670|NCT01988857|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
37671|NCT01988415|B1|Baseline|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
37672|NCT01988415|P1|Participant Flow|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
37673|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
37674|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
37675|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
37676|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
37677|NCT01988415|E2|Reported Event|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
37678|NCT01988415|E1|Reported Event|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
37679|NCT01988402|B3|Baseline|Total|Total of all reporting groups
37680|NCT01988402|B2|Baseline|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
37681|NCT01988402|B1|Baseline|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
37682|NCT01988402|P2|Participant Flow|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
37683|NCT01988402|P1|Participant Flow|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
37684|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
37685|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
37687|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
37688|NCT01988402|E2|Reported Event|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
37689|NCT01988402|E1|Reported Event|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
37690|NCT01988129|B3|Baseline|Total|Total of all reporting groups
37691|NCT01988129|B2|Baseline|Control|Current practice
37692|NCT01988129|B1|Baseline|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37693|NCT01988129|P2|Participant Flow|Control|"Current practice.~Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.~As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session."
37694|NCT01988129|P1|Participant Flow|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.~32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37695|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37696|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37697|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37698|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37699|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37700|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37701|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37750|NCT01987557|O1|Outcome|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
37751|NCT01987557|E3|Reported Event|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
37702|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37703|NCT01988129|O1|Outcome|Baseline (Intervention)|Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
37704|NCT01988129|O2|Outcome|Control|Current practice
37705|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37706|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37707|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37708|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37709|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37710|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
37711|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37712|NCT01988129|O2|Outcome|Control|Current practice
37713|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37714|NCT01988129|O2|Outcome|Control|Current practice
37752|NCT01987557|E2|Reported Event|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
37789|NCT01987219|P6|Participant Flow|Ipratropium; Placebo; Albuterol|Participants in this group received ipratropium followed by placebo followed by albuterol
37790|NCT01987219|P5|Participant Flow|Placebo; Albuterol; Ipratropium|Participants in this group received placebo followed by albuterol followed by ipratropium
37715|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37716|NCT01988129|O2|Outcome|Control|Current practice
37717|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
37718|NCT01988129|E2|Reported Event|Control|A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report.
37719|NCT01988129|E1|Reported Event|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations."
37720|NCT01987765|B1|Baseline|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
37721|NCT01987765|P1|Participant Flow|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
37722|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
37723|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
37724|NCT01987765|E1|Reported Event|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
37725|NCT01987752|B1|Baseline|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
37726|NCT01987752|P1|Participant Flow|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
37727|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
37728|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
37729|NCT01987752|E1|Reported Event|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
37730|NCT01987583|B3|Baseline|Total|Total of all reporting groups
37731|NCT01987583|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37732|NCT01987583|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37733|NCT01987583|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37781|NCT01987453|E1|Reported Event|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37734|NCT01987583|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37735|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37736|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37737|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37738|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37739|NCT01987583|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37740|NCT01987583|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
37741|NCT01987557|B4|Baseline|Total|Total of all reporting groups
37742|NCT01987557|B3|Baseline|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
37743|NCT01987557|B2|Baseline|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
37744|NCT01987557|B1|Baseline|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
37745|NCT01987557|P3|Participant Flow|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
37746|NCT01987557|P2|Participant Flow|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
37747|NCT01987557|P1|Participant Flow|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
37748|NCT01987557|O3|Outcome|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
37749|NCT01987557|O2|Outcome|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
37753|NCT01987557|E1|Reported Event|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
37754|NCT01987453|B4|Baseline|Total|Total of all reporting groups
37755|NCT01987453|B3|Baseline|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37756|NCT01987453|B2|Baseline|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37757|NCT01987453|B1|Baseline|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37758|NCT01987453|P3|Participant Flow|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37759|NCT01987453|P2|Participant Flow|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37760|NCT01987453|P1|Participant Flow|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37761|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37762|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37763|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37764|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37765|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37766|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37767|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37768|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37769|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37770|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37771|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37772|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37773|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37774|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37775|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37776|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37777|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37778|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
37779|NCT01987453|E3|Reported Event|LDV/SOF + RBV 24 Week (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
37780|NCT01987453|E2|Reported Event|LDV/SOF 24 Week (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
37791|NCT01987219|P4|Participant Flow|Placebo; Ipratropium; Albuterol|Participants in this group received placebo followed by ipratropium followed by albuterol
37792|NCT01987219|P3|Participant Flow|Albuterol; Ipratropium; Placebo|Participants in this group received albuterol followed by ipratropium followed by placebo
37793|NCT01987219|P2|Participant Flow|Albuterol; Placebo; Ipratropium|Participants in this group received albuterol followed by placebo followed by ipratropium
37794|NCT01987219|P1|Participant Flow|Ipratropium; Alubterol; Placebo|Participants in this group received ipratropium followed by albuterol followed by placebo
37795|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
37796|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
37797|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
37798|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
37799|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
37800|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
37801|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
37802|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
37803|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
37804|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
37805|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
37806|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
37807|NCT01987219|E3|Reported Event|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
37808|NCT01987219|E2|Reported Event|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
37809|NCT01987219|E1|Reported Event|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
37810|NCT01986985|B1|Baseline|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
37811|NCT01986985|P1|Participant Flow|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
37812|NCT01986985|O1|Outcome|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
37813|NCT01986985|E1|Reported Event|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
37814|NCT01986946|B3|Baseline|Total|Total of all reporting groups
37815|NCT01986946|B2|Baseline|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37816|NCT01986946|B1|Baseline|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
37817|NCT01986946|P2|Participant Flow|Epidural Catheter|"The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.~Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery."
37818|NCT01986946|P1|Participant Flow|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
37819|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
38999|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
37820|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37821|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37822|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37823|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37824|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37825|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37826|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37827|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37828|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37829|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37830|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37831|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37832|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37833|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37834|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37835|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37836|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37837|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37838|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37839|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37840|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37841|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37842|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37843|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37844|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
37845|NCT01986946|E2|Reported Event|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
37846|NCT01986946|E1|Reported Event|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
37847|NCT01986790|B4|Baseline|Total|Total of all reporting groups
37848|NCT01986790|B3|Baseline|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37849|NCT01986790|B2|Baseline|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37850|NCT01986790|B1|Baseline|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37851|NCT01986790|P3|Participant Flow|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37852|NCT01986790|P2|Participant Flow|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37853|NCT01986790|P1|Participant Flow|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37854|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37855|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37856|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37857|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37858|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37859|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37860|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37861|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37862|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37863|NCT01986790|E3|Reported Event|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
37864|NCT01986790|E2|Reported Event|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
37865|NCT01986790|E1|Reported Event|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
37866|NCT01986751|B3|Baseline|Total|Total of all reporting groups
37867|NCT01986751|B2|Baseline|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
37868|NCT01986751|B1|Baseline|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
37869|NCT01986751|P2|Participant Flow|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
37870|NCT01986751|P1|Participant Flow|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
37871|NCT01986751|O2|Outcome|Ropivacaine|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37872|NCT01986751|O1|Outcome|Clonidine and Ropivacaine|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37873|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37874|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37875|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37876|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37877|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37878|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37879|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37880|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37881|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37882|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37883|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37884|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37885|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37886|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
37887|NCT01986751|E2|Reported Event|Ropivacaine (Control)|Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
37888|NCT01986751|E1|Reported Event|Clonidine and Ropivacaine (Study Group)|A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
37889|NCT01986231|B1|Baseline|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
37890|NCT01986231|P1|Participant Flow|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
38309|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
37891|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
37892|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
37893|NCT01986231|E1|Reported Event|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
37894|NCT01986062|B3|Baseline|Total|Total of all reporting groups
37895|NCT01986062|B2|Baseline|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
37896|NCT01986062|B1|Baseline|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID for one week (crossover to placebo administration week 2)
37897|NCT01986062|P2|Participant Flow|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
37898|NCT01986062|P1|Participant Flow|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
37899|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37900|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37901|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37902|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37903|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37904|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37905|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37906|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37907|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37908|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37909|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
37910|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
37911|NCT01986062|E2|Reported Event|Placebo|Placebo, administered orally, BID for one week
37912|NCT01986062|E1|Reported Event|AR11|AR11, administered orally, BID for one week
37913|NCT01985581|B3|Baseline|Total|Total of all reporting groups
37914|NCT01985581|B2|Baseline|GXR First Then PLB|subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
37915|NCT01985581|B1|Baseline|PLB First Then GXR|subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
37916|NCT01985581|P2|Participant Flow|GXR First Then Placebo|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
37917|NCT01985581|P1|Participant Flow|Placebo First Then GXR|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
37918|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR (optimized dose 1-4 mg)
37919|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
37920|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR at optimized dose of 1-4 mg
37921|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
37922|NCT01985581|O2|Outcome|GXR and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and GXR (optimized dose 1-4 mg)
37923|NCT01985581|O1|Outcome|Placebo and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and placebo
37924|NCT01985581|O2|Outcome|Stimulant and Guanfancine Extended Release|"patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and also receive guanfacine extended release at a individually optimized dosage of 1-4 mg.~Guanfacine extended release"
39000|NCT01976299|O2|Outcome|Standard of Care|
37925|NCT01985581|O1|Outcome|Stimulant & Placebo|"patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)therapy plus placebo~Placebo"
37926|NCT01985581|O2|Outcome|GXR and Stimulant|Patients continued to take usual dose stimulant and optimized dose (1-4mg) of GXR
37927|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects continued to take usual dose stimulant and took placebo
37928|NCT01985581|O2|Outcome|GXR and Stimulant|The quality of life was measured in those patients taking GXR along with their usual stimulant therapy
37929|NCT01985581|O1|Outcome|Placebo and Stimulant|The quality of life was measured in those patients taking placebo along with their usual stimulant therapy
37930|NCT01985581|O2|Outcome|GXR and Stimulant|Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
37931|NCT01985581|O1|Outcome|Placebo and Stimulant|Subjects received placebo and usual stimulant therapy
37932|NCT01985581|E2|Reported Event|Stimulant and PLB|adverse event frequency in those taking stimulant + PLB
37933|NCT01985581|E1|Reported Event|Stimulant and GXR|adverse event frequency in those taking stimulant + GXR
37934|NCT01985425|B3|Baseline|Total|Total of all reporting groups
37935|NCT01985425|B2|Baseline|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37936|NCT01985425|B1|Baseline|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37937|NCT01985425|P2|Participant Flow|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37938|NCT01985425|P1|Participant Flow|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37939|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37940|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37941|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37942|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37943|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37944|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37945|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37946|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37947|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37948|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37949|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37982|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37950|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37951|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37952|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37953|NCT01985425|E2|Reported Event|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
37954|NCT01985425|E1|Reported Event|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
37955|NCT01985321|B3|Baseline|Total|Total of all reporting groups
37956|NCT01985321|B2|Baseline|Ethanol|36 applications over a 96 hour period
37957|NCT01985321|B1|Baseline|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
37958|NCT01985321|P2|Participant Flow|Ethanol|36 applications over a 96 hour period
37959|NCT01985321|P1|Participant Flow|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
37960|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
37961|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
37962|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
37963|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
37964|NCT01985321|E2|Reported Event|Ethanol|36 applications over a 96 hour period
37965|NCT01985321|E1|Reported Event|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
37966|NCT01985126|B3|Baseline|Total|Total of all reporting groups
37967|NCT01985126|B2|Baseline|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37968|NCT01985126|B1|Baseline|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37969|NCT01985126|P2|Participant Flow|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37970|NCT01985126|P1|Participant Flow|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37971|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37972|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37973|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37974|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37975|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37976|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37977|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37978|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37979|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37980|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37981|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
38144|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
37983|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37984|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37985|NCT01985126|E2|Reported Event|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37986|NCT01985126|E1|Reported Event|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
37987|NCT01984697|B6|Baseline|Total|Total of all reporting groups
37988|NCT01984697|B5|Baseline|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
37989|NCT01984697|B4|Baseline|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
37990|NCT01984697|B3|Baseline|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
37991|NCT01984697|B2|Baseline|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
37992|NCT01984697|B1|Baseline|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
37993|NCT01984697|P5|Participant Flow|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
37994|NCT01984697|P4|Participant Flow|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
37995|NCT01984697|P3|Participant Flow|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
37996|NCT01984697|P2|Participant Flow|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
37997|NCT01984697|P1|Participant Flow|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
37998|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
37999|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38000|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38001|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38002|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38003|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38004|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38005|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38006|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38007|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38008|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38009|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38010|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38011|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38012|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38013|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38014|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38015|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38016|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38017|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38018|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
86625|NCT01665170|E2|Reported Event|Verum|Verum arm - Pascoflair 425mg
38019|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38020|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38021|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38022|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38023|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38024|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38025|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38026|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38027|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38028|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38029|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38030|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38031|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38032|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38033|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38034|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38035|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38036|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38037|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38038|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38039|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38040|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38041|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38042|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38043|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38044|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38045|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38046|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38047|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38048|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38049|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38050|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38051|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38052|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38053|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38054|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38055|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38056|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38057|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38058|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38059|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38060|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38061|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38062|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38063|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38064|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38065|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38066|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38067|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38068|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38069|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38070|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38071|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38072|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38073|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38074|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38075|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38076|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38077|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38078|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38079|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38080|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38081|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38082|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38083|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38084|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38085|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38086|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38087|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38088|NCT01984697|E5|Reported Event|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38089|NCT01984697|E4|Reported Event|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
38090|NCT01984697|E3|Reported Event|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
38091|NCT01984697|E2|Reported Event|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38092|NCT01984697|E1|Reported Event|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
38093|NCT01984515|B1|Baseline|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38094|NCT01984515|P1|Participant Flow|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38095|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38096|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38097|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38098|NCT01984515|E1|Reported Event|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
38099|NCT01984294|B4|Baseline|Total|Total of all reporting groups
38100|NCT01984294|B3|Baseline|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38101|NCT01984294|B2|Baseline|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38102|NCT01984294|B1|Baseline|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38103|NCT01984294|P3|Participant Flow|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38104|NCT01984294|P2|Participant Flow|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38105|NCT01984294|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38106|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38107|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38108|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38109|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38110|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38111|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38112|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38113|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
86626|NCT01665170|E1|Reported Event|Placebo|Placebo arm
38114|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38115|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38116|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38117|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38118|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38119|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38120|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
38121|NCT01984294|E3|Reported Event|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
38122|NCT01984294|E2|Reported Event|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
38123|NCT01984294|E1|Reported Event|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
38124|NCT01984229|B3|Baseline|Total|Total of all reporting groups
38125|NCT01984229|B2|Baseline|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
38126|NCT01984229|B1|Baseline|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
38127|NCT01984229|P2|Participant Flow|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
38128|NCT01984229|P1|Participant Flow|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
38129|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38130|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38131|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38132|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38133|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38134|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38135|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38136|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38137|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38138|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38139|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38140|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38141|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38142|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38143|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38145|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38146|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38147|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38148|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38149|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38150|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38151|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38152|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38153|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38154|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38155|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38156|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38157|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38158|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38159|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38160|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38161|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38162|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38163|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38164|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38165|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38166|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38167|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38168|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38169|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38170|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38171|NCT01984229|E6|Reported Event|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38172|NCT01984229|E5|Reported Event|Cohort B: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
38173|NCT01984229|E4|Reported Event|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
38174|NCT01984229|E3|Reported Event|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
38175|NCT01984229|E2|Reported Event|Cohort A: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
38176|NCT01984229|E1|Reported Event|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
38177|NCT01983878|B1|Baseline|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38178|NCT01983878|P1|Participant Flow|Ramucirumab 8 mg/kg|Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38307|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
38179|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38180|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38181|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38182|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38183|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38184|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38185|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38186|NCT01983878|E1|Reported Event|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
38187|NCT01983839|B1|Baseline|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
38188|NCT01983839|P1|Participant Flow|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
38189|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
38190|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
38191|NCT01983839|E1|Reported Event|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
38192|NCT01983787|B1|Baseline|Pharmacokinetics Piperacillin|Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
38193|NCT01983787|P1|Participant Flow|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
38194|NCT01983787|O9|Outcome|Patient 10|MIC (mg/L) of pathogen detected in sputum: 2 mg/L
38195|NCT01983787|O8|Outcome|Patient 9|MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
38196|NCT01983787|O7|Outcome|Patient 8|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
38197|NCT01983787|O6|Outcome|Patient 7|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
38198|NCT01983787|O5|Outcome|Patient 6|MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
38199|NCT01983787|O4|Outcome|Patient 4|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
38200|NCT01983787|O3|Outcome|Patient 3|MIC (mg/L) of pathogen detected in sputum: 16 mg/L
38201|NCT01983787|O2|Outcome|Patient 2|MIC (mg/L) of pathogen detected in sputum: 8 mg/L
38202|NCT01983787|O1|Outcome|Patient 1|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
38203|NCT01983787|O9|Outcome|T>MIC 12g/Day, Patient 10|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38204|NCT01983787|O8|Outcome|T>MIC 12g/Day, Patient 9|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38242|NCT01983111|B2|Baseline|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38205|NCT01983787|O7|Outcome|T>MIC 12g/Day, Patient 8|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38206|NCT01983787|O6|Outcome|T>MIC 12g/Day, Patient 7|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38207|NCT01983787|O5|Outcome|T>MIC12g/Day, Patient 6|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38208|NCT01983787|O4|Outcome|T>MIC 16g/Day, Patient 4|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38209|NCT01983787|O3|Outcome|T>MIC 16g/Day, Patient 3|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38210|NCT01983787|O2|Outcome|T>MIC 16g/Day, Patient 2|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38211|NCT01983787|O1|Outcome|T>MIC 16g/Day, Patient 1|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
38212|NCT01983787|O2|Outcome|Pharmacokinetics Piperacillin 12g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
38213|NCT01983787|O1|Outcome|Pharmacokinetics Piperacillin 16g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
38214|NCT01983787|E1|Reported Event|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
38215|NCT01983566|B5|Baseline|Total|Total of all reporting groups
38216|NCT01983566|B4|Baseline|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
38217|NCT01983566|B3|Baseline|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele fasted.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
38218|NCT01983566|B2|Baseline|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
38219|NCT01983566|B1|Baseline|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Dele fasted, followed by a washout phase, followed by Dele after a standardised high-fat, high- calorie meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised low-fat meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
38220|NCT01983566|P4|Participant Flow|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
38243|NCT01983111|B1|Baseline|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38268|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38308|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
38221|NCT01983566|P3|Participant Flow|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
38222|NCT01983566|P2|Participant Flow|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
38223|NCT01983566|P1|Participant Flow|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Deleobuvir (Dele) film-coated tablets after an overnight fast of at least 10 hours (h), followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
38224|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
38225|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38226|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38227|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38228|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
38229|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38230|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38231|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38232|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
38233|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38234|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38235|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38236|NCT01983566|E5|Reported Event|OMP Alone|One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water.
38237|NCT01983566|E4|Reported Event|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
38238|NCT01983566|E3|Reported Event|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38239|NCT01983566|E2|Reported Event|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38240|NCT01983566|E1|Reported Event|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
38241|NCT01983111|B3|Baseline|Total|Total of all reporting groups
38244|NCT01983111|P2|Participant Flow|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38245|NCT01983111|P1|Participant Flow|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38246|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38247|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38248|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38249|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38250|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38251|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38252|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38253|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38254|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38255|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38256|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
38257|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
38258|NCT01983111|E2|Reported Event|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment."
38259|NCT01983111|E1|Reported Event|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment."
38260|NCT01982812|B3|Baseline|Total|Total of all reporting groups
38261|NCT01982812|B2|Baseline|Standard AED|"Standard AED regimen~Standard AED: Active comparitor, Standard AED"
38262|NCT01982812|B1|Baseline|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38263|NCT01982812|P2|Participant Flow|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38264|NCT01982812|P1|Participant Flow|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38265|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38266|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38267|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38269|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38270|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38271|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38272|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38273|NCT01982812|E2|Reported Event|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
38274|NCT01982812|E1|Reported Event|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
38275|NCT01982539|B1|Baseline|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
38276|NCT01982539|P1|Participant Flow|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
38277|NCT01982539|O1|Outcome|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
38278|NCT01982539|E1|Reported Event|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
38279|NCT01982292|B3|Baseline|Total|Total of all reporting groups
38280|NCT01982292|B2|Baseline|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38281|NCT01982292|B1|Baseline|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38282|NCT01982292|P2|Participant Flow|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38283|NCT01982292|P1|Participant Flow|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38284|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38285|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38286|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38287|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38288|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38289|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38290|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38291|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38292|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38293|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38294|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38295|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38296|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38297|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38298|NCT01982292|E2|Reported Event|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38299|NCT01982292|E1|Reported Event|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
38300|NCT01982253|B4|Baseline|Total|Total of all reporting groups
38301|NCT01982253|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
38302|NCT01982253|B2|Baseline|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
38303|NCT01982253|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
38304|NCT01982253|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
38305|NCT01982253|P2|Participant Flow|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
38306|NCT01982253|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
86627|NCT01665157|B4|Baseline|Total|Total of all reporting groups
38310|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
38311|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
38312|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
38313|NCT01982253|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
38314|NCT01982253|E2|Reported Event|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
38315|NCT01982253|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
38316|NCT01981967|B3|Baseline|Total|Total of all reporting groups
38317|NCT01981967|B2|Baseline|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38318|NCT01981967|B1|Baseline|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38319|NCT01981967|P2|Participant Flow|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38320|NCT01981967|P1|Participant Flow|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38321|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38322|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38323|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38324|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38325|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38326|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38327|NCT01981967|E2|Reported Event|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
38328|NCT01981967|E1|Reported Event|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
38329|NCT01981863|B3|Baseline|Total|Total of all reporting groups
38330|NCT01981863|B2|Baseline|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
38331|NCT01981863|B1|Baseline|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
38332|NCT01981863|P2|Participant Flow|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
38333|NCT01981863|P1|Participant Flow|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
38334|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
38335|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
38336|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
38337|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
38338|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
38339|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
38340|NCT01981863|E2|Reported Event|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm.~No adverse events to report."
38341|NCT01981863|E1|Reported Event|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.~No adverse advents to report."
38342|NCT01981616|B3|Baseline|Total|Total of all reporting groups
38343|NCT01981616|B2|Baseline|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38344|NCT01981616|B1|Baseline|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38345|NCT01981616|P2|Participant Flow|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38346|NCT01981616|P1|Participant Flow|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38347|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38348|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38349|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38350|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38351|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38352|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38353|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38354|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38355|NCT01981616|E2|Reported Event|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38356|NCT01981616|E1|Reported Event|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
38357|NCT01981473|B4|Baseline|Total|Total of all reporting groups
38358|NCT01981473|B3|Baseline|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38359|NCT01981473|B2|Baseline|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38360|NCT01981473|B1|Baseline|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38361|NCT01981473|P3|Participant Flow|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38362|NCT01981473|P2|Participant Flow|Adalimumab|Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38363|NCT01981473|P1|Participant Flow|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38364|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38365|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38366|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38367|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38368|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38369|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38370|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38371|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38372|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38373|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38374|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38375|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38376|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38377|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38378|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38379|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38380|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38381|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38382|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
90461|NCT01647438|B3|Baseline|Total|Total of all reporting groups
38383|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38384|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38385|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38386|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38387|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38388|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38389|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38390|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38391|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38392|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38393|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38394|NCT01981473|O2|Outcome|% AA-|Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
38395|NCT01981473|O1|Outcome|% AA+|Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
38396|NCT01981473|O2|Outcome|Adalimumab/ Infliximab|Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38397|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38398|NCT01981473|E3|Reported Event|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38399|NCT01981473|E2|Reported Event|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38400|NCT01981473|E1|Reported Event|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
38401|NCT01981356|B3|Baseline|Total|Total of all reporting groups
38402|NCT01981356|B2|Baseline|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38403|NCT01981356|B1|Baseline|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38404|NCT01981356|P2|Participant Flow|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38405|NCT01981356|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38406|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38407|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38471|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38408|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38409|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38410|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38411|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38412|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38413|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38414|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38415|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38416|NCT01981356|O1|Outcome|Inpatient Psychiatry Unit Staff Members|Barriers and facilitators were assessed through interviews of four inpatient psychiatry unit staff (on nursing assistant, one nurse, two psychologists).
38417|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38418|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38419|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38420|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38472|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
39001|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
38421|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38422|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38423|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38424|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38425|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
38426|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38427|NCT01981356|E2|Reported Event|Treatment as Usual (TAU)|"TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.~Treatment as Usual (TAU): All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate."
38428|NCT01981356|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
38429|NCT01981057|B3|Baseline|Total|Total of all reporting groups
38430|NCT01981057|B2|Baseline|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38431|NCT01981057|B1|Baseline|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38432|NCT01981057|P2|Participant Flow|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38433|NCT01981057|P1|Participant Flow|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38434|NCT01981057|O2|Outcome|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38435|NCT01981057|O1|Outcome|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38436|NCT01981057|E2|Reported Event|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38437|NCT01981057|E1|Reported Event|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
38438|NCT01980940|B9|Baseline|Total|Total of all reporting groups
38439|NCT01980940|B8|Baseline|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38440|NCT01980940|B7|Baseline|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38581|NCT01978600|E1|Reported Event|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38441|NCT01980940|B6|Baseline|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
38442|NCT01980940|B5|Baseline|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
38443|NCT01980940|B4|Baseline|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
38444|NCT01980940|B3|Baseline|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
38445|NCT01980940|B2|Baseline|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
38446|NCT01980940|B1|Baseline|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
38447|NCT01980940|P8|Participant Flow|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38448|NCT01980940|P7|Participant Flow|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38449|NCT01980940|P6|Participant Flow|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
38450|NCT01980940|P5|Participant Flow|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
38451|NCT01980940|P4|Participant Flow|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
38452|NCT01980940|P3|Participant Flow|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
38453|NCT01980940|P2|Participant Flow|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
38454|NCT01980940|P1|Participant Flow|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
38455|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38456|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38457|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38458|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38459|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38460|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38461|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38462|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38463|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38464|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38465|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38466|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38467|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38468|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38469|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38470|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38473|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38474|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38475|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38476|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38477|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38478|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38479|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38480|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38481|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38482|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38483|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38484|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38485|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38486|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38487|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38488|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38489|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38490|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38491|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38492|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38493|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38494|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38495|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38496|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38497|NCT01980940|E8|Reported Event|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
38498|NCT01980940|E7|Reported Event|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
38499|NCT01980940|E6|Reported Event|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
38500|NCT01980940|E5|Reported Event|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
38501|NCT01980940|E4|Reported Event|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
38502|NCT01980940|E3|Reported Event|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
38503|NCT01980940|E2|Reported Event|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
38504|NCT01980940|E1|Reported Event|ETOR 75 DMSO (Pt 1)|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
38505|NCT01980628|B1|Baseline|Ibrutinib|Patients receive a daily dose of 560 mg of ibrutinib capsules
38506|NCT01980628|P1|Participant Flow|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
38507|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
38508|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
38509|NCT01980628|E1|Reported Event|Ibrutinib|"ibrutinib capsules: 560 mg once daily~ibrutinib"
38510|NCT01980589|B4|Baseline|Total|Total of all reporting groups
38511|NCT01980589|B3|Baseline|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38512|NCT01980589|B2|Baseline|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38513|NCT01980589|B1|Baseline|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38953|NCT01976845|E2|Reported Event|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38514|NCT01980589|P3|Participant Flow|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38515|NCT01980589|P2|Participant Flow|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38516|NCT01980589|P1|Participant Flow|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38517|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38518|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38519|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38520|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38521|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38522|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38523|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38524|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38525|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38526|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38527|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38528|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38954|NCT01976845|E1|Reported Event|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38955|NCT01976806|B3|Baseline|Total|Total of all reporting groups
38529|NCT01980589|E3|Reported Event|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38530|NCT01980589|E2|Reported Event|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38531|NCT01980589|E1|Reported Event|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
38532|NCT01980095|B3|Baseline|Total|Total of all reporting groups
38533|NCT01980095|B2|Baseline|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
38534|NCT01980095|B1|Baseline|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."
38535|NCT01980095|P2|Participant Flow|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
38536|NCT01980095|P1|Participant Flow|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"
38537|NCT01980095|O2|Outcome|Active Drug Eradication Failure Subjects|These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
38538|NCT01980095|O1|Outcome|Placebo Subjects|These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
38539|NCT01980095|O2|Outcome|Placebo|"Capsules that look like the RHB-105 product but contain no active ingredient.~Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days."
38540|NCT01980095|O1|Outcome|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of:~Rifabutin 150 mg~Amoxicillin 3000 mg~Omeprazole 120 mg"
38541|NCT01980095|E2|Reported Event|Placebo|Identical capsules that look like the RHB-105 product but contain no active ingredient.
38542|NCT01980095|E1|Reported Event|RHB-105|RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.
38543|NCT01979185|B3|Baseline|Total|Total of all reporting groups
38544|NCT01979185|B2|Baseline|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
38545|NCT01979185|B1|Baseline|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
38546|NCT01979185|P2|Participant Flow|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
38547|NCT01979185|P1|Participant Flow|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
38548|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
38549|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
38550|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
38551|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
38552|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
38553|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
38554|NCT01979185|E2|Reported Event|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
38555|NCT01979185|E1|Reported Event|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
38556|NCT01979029|B3|Baseline|Total|Total of all reporting groups
38557|NCT01979029|B2|Baseline|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38558|NCT01979029|B1|Baseline|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38598|NCT01978145|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38559|NCT01979029|P2|Participant Flow|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38560|NCT01979029|P1|Participant Flow|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38561|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38562|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38563|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38564|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38565|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38566|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38567|NCT01979029|E2|Reported Event|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
38568|NCT01979029|E1|Reported Event|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
38569|NCT01978600|B3|Baseline|Total|Total of all reporting groups
38570|NCT01978600|B2|Baseline|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38571|NCT01978600|B1|Baseline|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38572|NCT01978600|P2|Participant Flow|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38573|NCT01978600|P1|Participant Flow|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38574|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38575|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38576|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38577|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38578|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38579|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
38580|NCT01978600|E2|Reported Event|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
38582|NCT01978145|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 4-week washout period. One inhalation of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI or one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI . Salbutamol/albuterol was provided to use as rescue medication.
38583|NCT01978145|P2|Participant Flow|Sequence 2: FSC MD DPI/Pl CB DPI Then Pl MD DPI/FSC CB DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a MD DPI and one inhalation of Placebo via a CB DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self admnistered one inhalation of matching Placebo via a MD DPI and one inhalation of FSC (250/50 mcg) via a CB DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38584|NCT01978145|P1|Participant Flow|Sequence 1: Pl MD DPI/FSC CB DPI Then FSC MD DPI/Pl CB DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) followed by one inhalation of single capsule containing Fluticasone propionate and salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self administered one inhalation of FSC (250/50 mcg) via the MD DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication
38585|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38586|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38587|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38588|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38589|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38590|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38591|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38592|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38593|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38594|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38595|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38596|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
38597|NCT01978145|E2|Reported Event|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
39002|NCT01976299|O2|Outcome|Standard of Care|
38599|NCT01978119|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
38600|NCT01978119|P2|Participant Flow|Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38601|NCT01978119|P1|Participant Flow|Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38602|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38603|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38604|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38605|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38606|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38607|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38608|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38609|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38610|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38611|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38612|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38613|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38991|NCT01976299|B1|Baseline|Active Treatment|"Standard of Care with the AVERT system~AVERT"
38614|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38615|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38616|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38617|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38618|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38619|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38620|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38621|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38622|NCT01978119|E2|Reported Event|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38623|NCT01978119|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
38624|NCT01977820|B3|Baseline|Total|Total of all reporting groups
38625|NCT01977820|B2|Baseline|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38626|NCT01977820|B1|Baseline|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38627|NCT01977820|P2|Participant Flow|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38628|NCT01977820|P1|Participant Flow|Sapropterin|Subject was administered with 20 milligram per kilogram (mg/kg) sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38629|NCT01977820|O2|Outcome|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
38630|NCT01977820|O1|Outcome|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
38814|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38631|NCT01977820|E2|Reported Event|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38632|NCT01977820|E1|Reported Event|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
38633|NCT01977794|B3|Baseline|Total|Total of all reporting groups
38634|NCT01977794|B2|Baseline|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38635|NCT01977794|B1|Baseline|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38636|NCT01977794|P2|Participant Flow|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP <140 mmHg and DBP <90 mmHg.
38637|NCT01977794|P1|Participant Flow|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)<90mmHg.
38638|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38639|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38666|NCT01977573|P3|Participant Flow|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38992|NCT01976299|P2|Participant Flow|Standard of Care|
38993|NCT01976299|P1|Participant Flow|Active Treatment|"Standard of Care with the AVERT system~AVERT"
38640|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38641|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38642|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38643|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38644|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38645|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38646|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38667|NCT01977573|P2|Participant Flow|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38815|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38647|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38648|NCT01977794|E2|Reported Event|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38649|NCT01977794|E1|Reported Event|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
38650|NCT01977729|B1|Baseline|All Study Participants|
38651|NCT01977729|P1|Participant Flow|All Participants|Only one participant was recruited, but never randomized.
38652|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
38653|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
38654|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
38655|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
38656|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
38657|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
38658|NCT01977729|E2|Reported Event|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
38659|NCT01977729|E1|Reported Event|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
38660|NCT01977573|B5|Baseline|Total|Total of all reporting groups
38661|NCT01977573|B4|Baseline|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38662|NCT01977573|B3|Baseline|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38663|NCT01977573|B2|Baseline|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38664|NCT01977573|B1|Baseline|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38665|NCT01977573|P4|Participant Flow|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38994|NCT01976299|O2|Outcome|Standard of Care|
38668|NCT01977573|P1|Participant Flow|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38669|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38670|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38671|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38672|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38673|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38674|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38675|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38676|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38677|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38678|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38679|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38680|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38681|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38682|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38683|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38684|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38685|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38686|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38995|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
38687|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38688|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38689|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38690|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38691|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38692|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38693|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38694|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38695|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38696|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38697|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38698|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38699|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38700|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38701|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38702|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38703|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38704|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38743|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38996|NCT01976299|O2|Outcome|Standard of Care|
38705|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38706|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38707|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38708|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38709|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38710|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38711|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38712|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38713|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38714|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38715|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38716|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38717|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38718|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38719|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38720|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38721|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38722|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38723|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38997|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
38724|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38725|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38726|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38727|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38728|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38729|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38730|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38731|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38732|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38733|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38734|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38735|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38736|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38737|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38738|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38739|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38740|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38741|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38742|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38744|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38745|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38746|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38747|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38748|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38749|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38750|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38751|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38752|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38753|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38754|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38755|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38756|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38757|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38758|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38759|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38760|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38761|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38762|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38763|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38764|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38765|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38766|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38767|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38768|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38769|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38770|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38771|NCT01977573|E4|Reported Event|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
38772|NCT01977573|E3|Reported Event|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
38773|NCT01977573|E2|Reported Event|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
38774|NCT01977573|E1|Reported Event|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
38775|NCT01977482|B7|Baseline|Total|Total of all reporting groups
38776|NCT01977482|B6|Baseline|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38777|NCT01977482|B5|Baseline|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38778|NCT01977482|B4|Baseline|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38779|NCT01977482|B3|Baseline|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38780|NCT01977482|B2|Baseline|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38781|NCT01977482|B1|Baseline|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38782|NCT01977482|P6|Participant Flow|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38783|NCT01977482|P5|Participant Flow|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38784|NCT01977482|P4|Participant Flow|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38785|NCT01977482|P3|Participant Flow|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38786|NCT01977482|P2|Participant Flow|GSK1278863 4 mg|Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38787|NCT01977482|P1|Participant Flow|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38788|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38789|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38790|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38791|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38792|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38793|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38794|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38795|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38796|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38797|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38798|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38799|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38800|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38801|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38802|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38803|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38804|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38805|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38806|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38807|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38808|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38809|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38810|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38811|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38812|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38813|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38816|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38817|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38818|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38819|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38820|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38821|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38822|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38823|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38824|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38825|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38826|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38827|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38828|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38829|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38830|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38831|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38832|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38833|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38834|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38835|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38836|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38837|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38838|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38839|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38840|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38841|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38842|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38843|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38844|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38845|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38846|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38847|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38848|NCT01977482|O5|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38849|NCT01977482|O4|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38850|NCT01977482|O3|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38851|NCT01977482|O2|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38852|NCT01977482|O1|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38853|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38854|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38855|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38856|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38857|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38858|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38859|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38860|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38861|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38862|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38863|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38864|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38865|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38866|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38867|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38868|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38869|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38870|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38871|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38872|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38873|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38874|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38875|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38876|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38877|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38878|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38879|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38880|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38881|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38882|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38883|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38884|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38885|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38886|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38887|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38888|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38889|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38890|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38891|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38892|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38893|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38894|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38895|NCT01977482|E6|Reported Event|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38896|NCT01977482|E5|Reported Event|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38897|NCT01977482|E4|Reported Event|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38898|NCT01977482|E3|Reported Event|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38950|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38998|NCT01976299|O2|Outcome|Standard of Care|
38899|NCT01977482|E2|Reported Event|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38900|NCT01977482|E1|Reported Event|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
38901|NCT01977456|B1|Baseline|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38902|NCT01977456|P1|Participant Flow|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38903|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38904|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38905|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38906|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38907|NCT01977456|E1|Reported Event|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
38908|NCT01976988|B3|Baseline|Total|Total of all reporting groups
38909|NCT01976988|B2|Baseline|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38910|NCT01976988|B1|Baseline|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38911|NCT01976988|P2|Participant Flow|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38912|NCT01976988|P1|Participant Flow|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38913|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38914|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38915|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38916|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
38917|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38918|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38919|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38920|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38921|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38922|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38923|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38924|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38925|NCT01976988|E2|Reported Event|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
38926|NCT01976988|E1|Reported Event|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
38927|NCT01976871|B1|Baseline|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38928|NCT01976871|P1|Participant Flow|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38929|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38951|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38952|NCT01976845|E3|Reported Event|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
94006|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
38930|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38931|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38932|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38933|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38934|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38935|NCT01976871|E1|Reported Event|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
38936|NCT01976845|B4|Baseline|Total|Total of all reporting groups
38937|NCT01976845|B3|Baseline|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
38938|NCT01976845|B2|Baseline|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38939|NCT01976845|B1|Baseline|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38940|NCT01976845|P3|Participant Flow|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
38941|NCT01976845|P2|Participant Flow|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38942|NCT01976845|P1|Participant Flow|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38943|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
38944|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38945|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38946|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
38947|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
38948|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
38949|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
38956|NCT01976806|B2|Baseline|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
38957|NCT01976806|B1|Baseline|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
38958|NCT01976806|P2|Participant Flow|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
38959|NCT01976806|P1|Participant Flow|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
38960|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
38961|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
38962|NCT01976806|E2|Reported Event|Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
38963|NCT01976806|E1|Reported Event|DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
38964|NCT01976650|B1|Baseline|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
38965|NCT01976650|P1|Participant Flow|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
38966|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
38967|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
38968|NCT01976650|E1|Reported Event|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
38969|NCT01976624|B1|Baseline|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
38970|NCT01976624|P1|Participant Flow|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
38971|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
38972|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
38973|NCT01976624|E1|Reported Event|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
38974|NCT01976572|B1|Baseline|All Subjects|
38975|NCT01976572|P3|Participant Flow|Treatment C|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
38976|NCT01976572|P2|Participant Flow|Treatment B|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
38977|NCT01976572|P1|Participant Flow|Treatment A|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
38978|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
38979|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
38980|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
38981|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
38982|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
38983|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
38984|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
38985|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
38986|NCT01976572|E3|Reported Event|Candesartan Plus Colestilan (Day 7 to 24)|
38987|NCT01976572|E2|Reported Event|Colestilan Alone (Day 3 to 6)|
38988|NCT01976572|E1|Reported Event|Candesartan Alone (Day 1 to 2)|
38989|NCT01976299|B3|Baseline|Total|Total of all reporting groups
38990|NCT01976299|B2|Baseline|Standard of Care|
39003|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
39004|NCT01976299|E2|Reported Event|Standard of Care|
39005|NCT01976299|E1|Reported Event|Active Treatment|"Standard of Care with the AVERT system~AVERT"
39006|NCT01975974|B1|Baseline|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
39007|NCT01975974|P1|Participant Flow|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
39008|NCT01975974|O1|Outcome|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
39009|NCT01975974|E1|Reported Event|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
39010|NCT01975675|B5|Baseline|Total|Total of all reporting groups
39011|NCT01975675|B4|Baseline|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39012|NCT01975675|B3|Baseline|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39013|NCT01975675|B2|Baseline|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39014|NCT01975675|B1|Baseline|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39015|NCT01975675|P4|Participant Flow|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39016|NCT01975675|P3|Participant Flow|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39017|NCT01975675|P2|Participant Flow|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39018|NCT01975675|P1|Participant Flow|LDV/SOF (Treatment Naive)|Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
39019|NCT01975675|O2|Outcome|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39020|NCT01975675|O1|Outcome|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39021|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39022|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39023|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39024|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39025|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39026|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39027|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39028|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39029|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39030|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39031|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39032|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39033|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39034|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39035|NCT01975675|E2|Reported Event|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
39036|NCT01975675|E1|Reported Event|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
39037|NCT01975467|B3|Baseline|Total|Total of all reporting groups
39038|NCT01975467|B2|Baseline|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
39039|NCT01975467|B1|Baseline|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
39040|NCT01975467|P2|Participant Flow|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
39041|NCT01975467|P1|Participant Flow|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
39042|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
39043|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
39044|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
39045|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
39046|NCT01975467|E2|Reported Event|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
39047|NCT01975467|E1|Reported Event|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
39048|NCT01975285|B3|Baseline|Total|Total of all reporting groups
39049|NCT01975285|B2|Baseline|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39050|NCT01975285|B1|Baseline|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39051|NCT01975285|P2|Participant Flow|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39052|NCT01975285|P1|Participant Flow|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39053|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39054|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39055|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39056|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39057|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39058|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39059|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39060|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39061|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39062|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39063|NCT01975285|E2|Reported Event|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
39064|NCT01975285|E1|Reported Event|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
39065|NCT01975246|B3|Baseline|Total|Total of all reporting groups
39066|NCT01975246|B2|Baseline|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39067|NCT01975246|B1|Baseline|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39068|NCT01975246|P2|Participant Flow|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39069|NCT01975246|P1|Participant Flow|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39070|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39071|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39072|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39073|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39074|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39113|NCT01974817|O1|Outcome|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
39075|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39076|NCT01975246|E2|Reported Event|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
39077|NCT01975246|E1|Reported Event|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
39078|NCT01974895|B3|Baseline|Total|Total of all reporting groups
39079|NCT01974895|B2|Baseline|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39080|NCT01974895|B1|Baseline|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39081|NCT01974895|P2|Participant Flow|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39082|NCT01974895|P1|Participant Flow|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39083|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39084|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39085|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39086|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39087|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39088|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39089|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39090|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39091|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39092|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39093|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39094|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39095|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39096|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39097|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39098|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39099|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39100|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39101|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39102|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39103|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39104|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39105|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39106|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39107|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39108|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39109|NCT01974895|E2|Reported Event|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
39110|NCT01974895|E1|Reported Event|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
39111|NCT01974817|B1|Baseline|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
39112|NCT01974817|P1|Participant Flow|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
39114|NCT01974817|E1|Reported Event|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
39115|NCT01974752|B3|Baseline|Total|Total of all reporting groups
39116|NCT01974752|B2|Baseline|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39117|NCT01974752|B1|Baseline|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39118|NCT01974752|P2|Participant Flow|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39119|NCT01974752|P1|Participant Flow|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39120|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39121|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39122|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39123|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39124|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39125|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39126|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39127|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39128|NCT01974752|E2|Reported Event|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
39129|NCT01974752|E1|Reported Event|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
39130|NCT01974700|B3|Baseline|Total|Total of all reporting groups
39131|NCT01974700|B2|Baseline|No Anti-epileptic Treatment|
39132|NCT01974700|B1|Baseline|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39133|NCT01974700|P2|Participant Flow|No Anti-epileptic Treatment|
39134|NCT01974700|P1|Participant Flow|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39135|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
39136|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39137|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
39138|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39139|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
39140|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39141|NCT01974700|E2|Reported Event|No Anti-epileptic Treatment|
39142|NCT01974700|E1|Reported Event|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
39143|NCT01974323|B3|Baseline|Total|Total of all reporting groups
39144|NCT01974323|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39145|NCT01974323|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39146|NCT01974323|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39147|NCT01974323|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39148|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39149|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39150|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39151|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39152|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39153|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39154|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39155|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39156|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39157|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39158|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39159|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39160|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39161|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39162|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39163|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39164|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39165|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39166|NCT01974323|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39167|NCT01974323|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39168|NCT01974245|B3|Baseline|Total|Total of all reporting groups
39169|NCT01974245|B2|Baseline|Cholecalciferol|Cholecalciferol: 100,000 IU/week
39170|NCT01974245|B1|Baseline|Placebo|100 drops/week
39171|NCT01974245|P2|Participant Flow|Cholecalciferol|Cholecalciferol: 100,000 IU/week
39172|NCT01974245|P1|Participant Flow|Placebo|100 drops placebo solution/week
39173|NCT01974245|O2|Outcome|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
39174|NCT01974245|O1|Outcome|Placebo|100 drops/week for 12 weeks
39175|NCT01974245|E2|Reported Event|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
39176|NCT01974245|E1|Reported Event|Placebo|100 drops/week for 12 weeks
39177|NCT01974141|B3|Baseline|Total|Total of all reporting groups
39178|NCT01974141|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39179|NCT01974141|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39180|NCT01974141|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39181|NCT01974141|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39182|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39183|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39184|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39185|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39186|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39187|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39188|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39189|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39190|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39191|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39192|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39193|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39194|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39195|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39196|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39197|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39198|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39199|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39200|NCT01974141|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39201|NCT01974141|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
39202|NCT01973777|B1|Baseline|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39203|NCT01973777|P1|Participant Flow|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39204|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39205|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39206|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39207|NCT01973777|E1|Reported Event|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
39208|NCT01973608|B5|Baseline|Total|Total of all reporting groups
39209|NCT01973608|B4|Baseline|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39248|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
39318|NCT01973218|E1|Reported Event|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39319|NCT01973205|B3|Baseline|Total|Total of all reporting groups
39210|NCT01973608|B3|Baseline|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39211|NCT01973608|B2|Baseline|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39212|NCT01973608|B1|Baseline|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39213|NCT01973608|P4|Participant Flow|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39214|NCT01973608|P3|Participant Flow|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39215|NCT01973608|P2|Participant Flow|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39216|NCT01973608|P1|Participant Flow|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39217|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39218|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39219|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39220|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
39221|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39222|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39223|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39224|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39225|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39226|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39227|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39228|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39320|NCT01973205|B2|Baseline|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39229|NCT01973608|E4|Reported Event|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39230|NCT01973608|E3|Reported Event|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39231|NCT01973608|E2|Reported Event|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39232|NCT01973608|E1|Reported Event|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
39233|NCT01973595|B5|Baseline|Total|Total of all reporting groups
39234|NCT01973595|B4|Baseline|No Almonds, Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
39235|NCT01973595|B3|Baseline|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste"
39236|NCT01973595|B2|Baseline|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
39237|NCT01973595|B1|Baseline|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39238|NCT01973595|P4|Participant Flow|No Almonds Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
39239|NCT01973595|P3|Participant Flow|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39240|NCT01973595|P2|Participant Flow|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
39241|NCT01973595|P1|Participant Flow|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39242|NCT01973595|O4|Outcome|No Almonds Consumption Control (Children)|"Children were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
39243|NCT01973595|O3|Outcome|Almonds Consumption (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39244|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
39245|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39246|NCT01973595|O2|Outcome|No Almond Consumption Control|"Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.~Each group received the almond intervention and the no almond consumption control."
39247|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39370|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39249|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39250|NCT01973595|O2|Outcome|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
39251|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39252|NCT01973595|E2|Reported Event|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
39253|NCT01973595|E1|Reported Event|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
39254|NCT01973439|B1|Baseline|Single Arm|This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir
39255|NCT01973439|P1|Participant Flow|Single Arm|"This is a single arm crossover study~st intervention: PK assessment while on Twice Daily Abacavir~nd intervention: PK assessment while on Once Daily Abacavir"
39256|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
39257|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
39258|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
39259|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
39260|NCT01973439|E1|Reported Event|Abacavir Once Versus Twice Daily|This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
39261|NCT01973413|B3|Baseline|Total|Total of all reporting groups
39262|NCT01973413|B2|Baseline|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
39263|NCT01973413|B1|Baseline|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
39264|NCT01973413|P2|Participant Flow|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
39265|NCT01973413|P1|Participant Flow|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
39266|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
39285|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39267|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
39268|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
39269|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
39270|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
39271|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
39272|NCT01973413|E2|Reported Event|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
39273|NCT01973413|E1|Reported Event|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
39274|NCT01973231|B3|Baseline|Total|Total of all reporting groups
39275|NCT01973231|B2|Baseline|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39276|NCT01973231|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39277|NCT01973231|P2|Participant Flow|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39278|NCT01973231|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39279|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39280|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39281|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39282|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39283|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39284|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39286|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39287|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39288|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39289|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39290|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39291|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39292|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39293|NCT01973231|E2|Reported Event|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
39294|NCT01973231|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
39295|NCT01973218|B3|Baseline|Total|Total of all reporting groups
39296|NCT01973218|B2|Baseline|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39297|NCT01973218|B1|Baseline|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39298|NCT01973218|P2|Participant Flow|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39299|NCT01973218|P1|Participant Flow|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39300|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39301|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39302|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39303|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39304|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39305|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39306|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39307|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39308|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39309|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39310|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39311|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39312|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39313|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39314|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39315|NCT01973218|O1|Outcome|rMenb|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
39316|NCT01973218|E3|Reported Event|Total|Total of subjects
39317|NCT01973218|E2|Reported Event|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
39371|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39321|NCT01973205|B1|Baseline|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39322|NCT01973205|P2|Participant Flow|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39323|NCT01973205|P1|Participant Flow|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39324|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39325|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39326|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39327|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39328|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39329|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39330|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39331|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39332|NCT01973205|E2|Reported Event|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
39333|NCT01973205|E1|Reported Event|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
39334|NCT01972776|B7|Baseline|Total|Total of all reporting groups
39335|NCT01972776|B6|Baseline|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39336|NCT01972776|B5|Baseline|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39337|NCT01972776|B4|Baseline|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39338|NCT01972776|B3|Baseline|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39339|NCT01972776|B2|Baseline|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39340|NCT01972776|B1|Baseline|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39341|NCT01972776|P6|Participant Flow|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39342|NCT01972776|P5|Participant Flow|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39343|NCT01972776|P4|Participant Flow|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39344|NCT01972776|P3|Participant Flow|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39345|NCT01972776|P2|Participant Flow|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39346|NCT01972776|P1|Participant Flow|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39347|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39348|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39349|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39350|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39351|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39352|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39353|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39354|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39355|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39356|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39357|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39358|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39359|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39360|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39361|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39362|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39363|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39364|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39365|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39366|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39367|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39368|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39369|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
94007|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
39372|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39373|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39374|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39375|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39376|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39377|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39378|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39379|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39380|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39381|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39382|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39383|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39384|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39385|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39386|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39387|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39388|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39389|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39390|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39391|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39392|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39393|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39394|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39395|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39396|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39397|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39398|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39399|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39400|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39401|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
39402|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
39403|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
39404|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
39405|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
39406|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
39407|NCT01972776|E6|Reported Event|Part 2:QBM076 B.I.D Placebo|Part 2:QBM076 B.I.D Placebo
39408|NCT01972776|E5|Reported Event|Part 2: QBM076 B.I.D 150 mg|Part 2: QBM076 B.I.D 150 mg
39409|NCT01972776|E4|Reported Event|Part 1: Placebo|Part 1: Placebo
39410|NCT01972776|E3|Reported Event|Part 1: QBM076 B.I.D 150 mg|Part 1: QBM076 B.I.D 150 mg
39411|NCT01972776|E2|Reported Event|Part 1: QBM076 B.I.D 75 mg|Part 1: QBM076 B.I.D 75 mg
39412|NCT01972776|E1|Reported Event|Part 1: QBM076 B.I.D 25 mg|Part 1: QBM076 B.I.D 25 mg
39413|NCT01972659|B3|Baseline|Total|Total of all reporting groups
39414|NCT01972659|B2|Baseline|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39415|NCT01972659|B1|Baseline|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39416|NCT01972659|P2|Participant Flow|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39417|NCT01972659|P1|Participant Flow|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39418|NCT01972659|O2|Outcome|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39419|NCT01972659|O1|Outcome|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39468|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39420|NCT01972659|E2|Reported Event|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39421|NCT01972659|E1|Reported Event|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
39422|NCT01972516|B3|Baseline|Total|Total of all reporting groups
39423|NCT01972516|B2|Baseline|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39424|NCT01972516|B1|Baseline|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39425|NCT01972516|P2|Participant Flow|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39426|NCT01972516|P1|Participant Flow|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39427|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39428|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39429|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39430|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39431|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39432|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39433|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39434|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39435|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39436|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39437|NCT01972516|E2|Reported Event|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
39438|NCT01972516|E1|Reported Event|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
39439|NCT01972438|B3|Baseline|Total|Total of all reporting groups
39440|NCT01972438|B2|Baseline|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39441|NCT01972438|B1|Baseline|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39442|NCT01972438|P2|Participant Flow|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39605|NCT01971554|E3|Reported Event|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39443|NCT01972438|P1|Participant Flow|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39444|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39445|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39446|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39447|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39448|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39449|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39450|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39451|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39452|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39453|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39454|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39455|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39456|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39457|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39458|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39459|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39460|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39461|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39462|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39463|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39464|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39465|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39466|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39467|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39606|NCT01971554|E2|Reported Event|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39469|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39470|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39471|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39472|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39473|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39474|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39475|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39476|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39477|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39478|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39479|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39480|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39481|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39482|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39483|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39484|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39485|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39486|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39487|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39488|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
39489|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
39490|NCT01972438|E4|Reported Event|No Intervention|Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
39491|NCT01972438|E3|Reported Event|ASEDs or Saline|Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
39492|NCT01972438|E2|Reported Event|Saline|Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
39493|NCT01972438|E1|Reported Event|ASEDs|Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
39494|NCT01972152|B1|Baseline|Total Study Group|Includes all 30 randomized subjects
39607|NCT01971554|E1|Reported Event|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39649|NCT01970982|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
94008|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
39495|NCT01972152|P6|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
39496|NCT01972152|P5|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
39497|NCT01972152|P4|Participant Flow|G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
39498|NCT01972152|P3|Participant Flow|G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
39499|NCT01972152|P2|Participant Flow|G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
39500|NCT01972152|P1|Participant Flow|G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
39501|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39502|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39503|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39504|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39505|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39506|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39507|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39508|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39509|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39510|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39511|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39512|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39513|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39514|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39515|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39516|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39517|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39518|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39519|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39520|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39521|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39522|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39523|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39524|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39525|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
39526|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
39527|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
39528|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39529|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39530|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39531|NCT01972152|E3|Reported Event|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39532|NCT01972152|E2|Reported Event|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39533|NCT01972152|E1|Reported Event|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
39534|NCT01971723|B3|Baseline|Total|Total of all reporting groups
39535|NCT01971723|B2|Baseline|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39536|NCT01971723|B1|Baseline|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39537|NCT01971723|P2|Participant Flow|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39538|NCT01971723|P1|Participant Flow|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39539|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39540|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39541|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39542|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39543|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39544|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39545|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39546|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39547|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39608|NCT01971086|B1|Baseline|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39650|NCT01970982|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
39548|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39549|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39550|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39551|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39552|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39553|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39554|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39555|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39556|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39557|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39558|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39559|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39560|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39609|NCT01971086|P1|Participant Flow|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39561|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39562|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39563|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39564|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39565|NCT01971723|E2|Reported Event|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
39566|NCT01971723|E1|Reported Event|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
39567|NCT01971554|B5|Baseline|Total|Total of all reporting groups
39568|NCT01971554|B4|Baseline|Placebo|Placebo once daily for 14 consecutive days
39569|NCT01971554|B3|Baseline|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39570|NCT01971554|B2|Baseline|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39571|NCT01971554|B1|Baseline|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39572|NCT01971554|P4|Participant Flow|Placebo|Placebo once daily for 14 consecutive days
39573|NCT01971554|P3|Participant Flow|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39574|NCT01971554|P2|Participant Flow|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39575|NCT01971554|P1|Participant Flow|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39576|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39577|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39578|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39579|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39580|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39581|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39582|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39583|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39584|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39585|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39586|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39587|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39588|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39589|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39590|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39591|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39592|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39593|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39594|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39595|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39596|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39597|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39598|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39599|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39600|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
39601|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
39602|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
39603|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
39604|NCT01971554|E4|Reported Event|Placebo|Placebo once daily for 14 consecutive days
39610|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39611|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39612|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39613|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39614|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39615|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39616|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39617|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39618|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39619|NCT01971086|E1|Reported Event|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
39620|NCT01970995|B4|Baseline|Total|Total of all reporting groups
39621|NCT01970995|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39622|NCT01970995|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39623|NCT01970995|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39624|NCT01970995|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39625|NCT01970995|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39626|NCT01970995|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39627|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39628|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39629|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39630|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39631|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39632|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39633|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39634|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39635|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39636|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39637|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39638|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39639|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39640|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39641|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39642|NCT01970995|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
39643|NCT01970995|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
39644|NCT01970995|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
39645|NCT01970982|B4|Baseline|Total|Total of all reporting groups
39646|NCT01970982|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39647|NCT01970982|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
39648|NCT01970982|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39651|NCT01970982|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39652|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39653|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
39654|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39655|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39656|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
39657|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39658|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39659|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
39660|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39661|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39662|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
39663|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39664|NCT01970982|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
39665|NCT01970982|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
39666|NCT01970982|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
39667|NCT01970982|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
39668|NCT01970878|B5|Baseline|Total|Total of all reporting groups
39669|NCT01970878|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39670|NCT01970878|B3|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
39671|NCT01970878|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg
39672|NCT01970878|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39673|NCT01970878|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39674|NCT01970878|P3|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
39675|NCT01970878|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg
39676|NCT01970878|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39677|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39678|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
39679|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
39680|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39681|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39682|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
39683|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
39684|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39685|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39686|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
39687|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
39688|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39689|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39690|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
39691|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
39692|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39693|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39694|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
39695|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
39696|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39697|NCT01970878|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
39698|NCT01970878|E3|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
39699|NCT01970878|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg
39700|NCT01970878|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
39701|NCT01970787|B1|Baseline|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39702|NCT01970787|P1|Participant Flow|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39703|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39704|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39705|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39706|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39707|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39818|NCT01969747|B1|Baseline|Placebo|Placebo tablet; oral administration once daily
39708|NCT01970787|E1|Reported Event|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
39709|NCT01970488|B3|Baseline|Total|Total of all reporting groups
39710|NCT01970488|B2|Baseline|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39711|NCT01970488|B1|Baseline|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39712|NCT01970488|P5|Participant Flow|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39713|NCT01970488|P4|Participant Flow|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39714|NCT01970488|P3|Participant Flow|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39715|NCT01970488|P2|Participant Flow|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39716|NCT01970488|P1|Participant Flow|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39717|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39718|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39719|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39720|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39721|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39722|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39723|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39724|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39725|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39726|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39727|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39728|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39729|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39730|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39731|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39732|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39733|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39734|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39735|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39736|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39737|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39738|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39739|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39740|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39741|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39819|NCT01969747|P4|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
39742|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39743|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39744|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39745|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39746|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39747|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39748|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39749|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39750|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39751|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39752|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39753|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39754|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39755|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39756|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39757|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39758|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39759|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39760|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39761|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39762|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39763|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39764|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39765|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39766|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39767|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39768|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
39769|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39770|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39771|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39772|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39773|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39774|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39775|NCT01970488|E5|Reported Event|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
94009|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
39776|NCT01970488|E4|Reported Event|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
39777|NCT01970488|E3|Reported Event|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
39778|NCT01970488|E2|Reported Event|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39779|NCT01970488|E1|Reported Event|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
39780|NCT01970475|B3|Baseline|Total|Total of all reporting groups
39781|NCT01970475|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39782|NCT01970475|B1|Baseline|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39783|NCT01970475|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39784|NCT01970475|P1|Participant Flow|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39785|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39786|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39787|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39788|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39789|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39790|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39791|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39792|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39793|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39794|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39795|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39796|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39797|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39798|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39799|NCT01970475|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39800|NCT01970475|E1|Reported Event|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
39801|NCT01970397|B3|Baseline|Total|Total of all reporting groups
39802|NCT01970397|B2|Baseline|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39803|NCT01970397|B1|Baseline|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39804|NCT01970397|P2|Participant Flow|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39805|NCT01970397|P1|Participant Flow|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39806|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39807|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39808|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39809|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39810|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39811|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39812|NCT01970397|E2|Reported Event|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39813|NCT01970397|E1|Reported Event|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
39814|NCT01969747|B5|Baseline|Total|Total of all reporting groups
39815|NCT01969747|B4|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
39816|NCT01969747|B3|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
39817|NCT01969747|B2|Baseline|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
94255|NCT01628848|B2|Baseline|Placebo|Placebo transdermal patch
39820|NCT01969747|P3|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
39821|NCT01969747|P2|Participant Flow|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
39822|NCT01969747|P1|Participant Flow|Placebo|Placebo tablet; oral administration once daily
39823|NCT01969747|O4|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
39824|NCT01969747|O3|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
39825|NCT01969747|O2|Outcome|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
39826|NCT01969747|O1|Outcome|Placebo|Placebo tablet; oral administration once daily
39827|NCT01969747|E4|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
39828|NCT01969747|E3|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
39829|NCT01969747|E2|Reported Event|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
39830|NCT01969747|E1|Reported Event|Placebo|Placebo tablet; oral administration once daily
39831|NCT01969721|B1|Baseline|Overall Study|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
39832|NCT01969721|P4|Participant Flow|F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
39833|NCT01969721|P3|Participant Flow|F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
39834|NCT01969721|P2|Participant Flow|T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
39835|NCT01969721|P1|Participant Flow|T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled .~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 2.5/5).~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 5/5).~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 250/50).~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 500/50).~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
39836|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39837|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39838|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
40806|NCT01964352|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
39839|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39840|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39841|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39842|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39843|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39844|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39845|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39846|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39847|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39848|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39849|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39850|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39851|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39852|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39853|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39854|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39855|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39875|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39856|NCT01969721|E4|Reported Event|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39857|NCT01969721|E3|Reported Event|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
39858|NCT01969721|E2|Reported Event|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39859|NCT01969721|E1|Reported Event|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
39860|NCT01969565|B1|Baseline|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
39861|NCT01969565|P1|Participant Flow|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
39862|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
39863|NCT01969565|E1|Reported Event|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
39864|NCT01969539|B1|Baseline|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39865|NCT01969539|P1|Participant Flow|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39866|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39867|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39868|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39869|NCT01969539|E1|Reported Event|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
39870|NCT01969435|B1|Baseline|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39871|NCT01969435|P1|Participant Flow|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39872|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39873|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39874|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
40061|NCT01967121|E3|Reported Event|Control|This is a control group where subjects will not perform an intervention.
94256|NCT01628848|B1|Baseline|SPM 962|SPM 962 transdermal patch
39876|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39877|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39878|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39879|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39880|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39881|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39882|NCT01969435|E1|Reported Event|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
39883|NCT01969162|B1|Baseline|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
39884|NCT01969162|P1|Participant Flow|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
39885|NCT01969162|O1|Outcome|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
39886|NCT01969162|E1|Reported Event|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
39887|NCT01969084|B3|Baseline|Total|Total of all reporting groups
39888|NCT01969084|B2|Baseline|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
39889|NCT01969084|B1|Baseline|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
39890|NCT01969084|P2|Participant Flow|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
39891|NCT01969084|P1|Participant Flow|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
39892|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
39893|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
39894|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
39895|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
40104|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
39896|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity"
39897|NCT01969084|O1|Outcome|Linagliptin|Linagliptin treated group
39898|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
39899|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
39900|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
39901|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
39902|NCT01969084|E2|Reported Event|Sugar Pill|"Subjects given sugar pill/placebo~Placebo"
39903|NCT01969084|E1|Reported Event|Linagliptin|Subjects given Linagliptin
39904|NCT01968811|B1|Baseline|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
39905|NCT01968811|P1|Participant Flow|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
39906|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
39907|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
39908|NCT01968811|E1|Reported Event|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
39909|NCT01968551|B4|Baseline|Total|Total of all reporting groups
39910|NCT01968551|B3|Baseline|Cohort 2: SBR|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks
39911|NCT01968551|B2|Baseline|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
39912|NCT01968551|B1|Baseline|Cohort 1|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
39913|NCT01968551|P3|Participant Flow|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
39914|NCT01968551|P2|Participant Flow|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
39915|NCT01968551|P1|Participant Flow|Cohort 1: E/C/F/TAF+DRV|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for 48 weeks
39916|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
39917|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for 48 weeks
39918|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
39919|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
39920|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks with the option to switch to E/C/F/TAF in the extension phase.
39921|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
39922|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
39923|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
39924|NCT01968551|E4|Reported Event|All E/C/F/TAF|All participants who received E/C/F/TAF during the Open-Label Phase or Extension Phase
39925|NCT01968551|E3|Reported Event|Cohort 2: SBR|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks
39926|NCT01968551|E2|Reported Event|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
39927|NCT01968551|E1|Reported Event|Cohort 1|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
39928|NCT01968434|B3|Baseline|Total|Total of all reporting groups
39929|NCT01968434|B2|Baseline|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
39930|NCT01968434|B1|Baseline|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
39931|NCT01968434|P2|Participant Flow|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
39932|NCT01968434|P1|Participant Flow|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
39933|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
39934|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
39935|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
39936|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
39937|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
39938|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
39939|NCT01968434|E2|Reported Event|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
39940|NCT01968434|E1|Reported Event|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
39941|NCT01968135|B3|Baseline|Total|Total of all reporting groups
39942|NCT01968135|B2|Baseline|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39943|NCT01968135|B1|Baseline|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39944|NCT01968135|P2|Participant Flow|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39945|NCT01968135|P1|Participant Flow|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39946|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39947|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39948|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39949|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39950|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39951|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39952|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39953|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39954|NCT01968135|E2|Reported Event|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
39955|NCT01968135|E1|Reported Event|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
39956|NCT01967784|B1|Baseline|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39957|NCT01967784|P1|Participant Flow|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39958|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39959|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39960|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39961|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39962|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39963|NCT01967784|E1|Reported Event|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
39964|NCT01967732|B3|Baseline|Total|Total of all reporting groups
39965|NCT01967732|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39966|NCT01967732|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39967|NCT01967732|P4|Participant Flow|NNS Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
39968|NCT01967732|P3|Participant Flow|THS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
39969|NCT01967732|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
39970|NCT01967732|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
39971|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39972|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39973|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39974|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39975|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39976|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39977|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39978|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39979|NCT01967732|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
39980|NCT01967732|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
39981|NCT01967719|B3|Baseline|Total|Total of all reporting groups
39982|NCT01967719|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
39983|NCT01967719|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
39984|NCT01967719|P4|Participant Flow|NNS Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
39985|NCT01967719|P3|Participant Flow|mTHS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
39986|NCT01967719|P2|Participant Flow|mCC Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
39987|NCT01967719|P1|Participant Flow|mTHS 2.2 Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
39988|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
94257|NCT01628848|P2|Participant Flow|Placebo|Placebo transdermal patch
39989|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
39990|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
39991|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2."
39992|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
39993|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
39994|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
39995|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
39996|NCT01967719|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
39997|NCT01967719|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
39998|NCT01967719|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
39999|NCT01967706|B3|Baseline|Total|Total of all reporting groups
40000|NCT01967706|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
40001|NCT01967706|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
40002|NCT01967706|P4|Participant Flow|NRT Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
40003|NCT01967706|P3|Participant Flow|mTHS Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT)"
40004|NCT01967706|P2|Participant Flow|mCC Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
40005|NCT01967706|P1|Participant Flow|mTHS Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
40006|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
40007|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS."
40008|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
40009|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
40010|NCT01967706|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
40011|NCT01967706|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
40012|NCT01967706|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
40013|NCT01967550|B3|Baseline|Total|Total of all reporting groups
40014|NCT01967550|B2|Baseline|Placebo|Vehicle control
40015|NCT01967550|B1|Baseline|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
40016|NCT01967550|P2|Participant Flow|Placebo|Vehicle control
40017|NCT01967550|P1|Participant Flow|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
40018|NCT01967550|O2|Outcome|Placebo|Vehicle control
40019|NCT01967550|O1|Outcome|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
40020|NCT01967550|E2|Reported Event|Placebo|Vehicle control
40021|NCT01967550|E1|Reported Event|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
40022|NCT01967277|B3|Baseline|Total|Total of all reporting groups
40023|NCT01967277|B2|Baseline|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
40024|NCT01967277|B1|Baseline|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
40025|NCT01967277|P2|Participant Flow|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
40026|NCT01967277|P1|Participant Flow|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
40105|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40027|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
40028|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
40029|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
40030|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
40031|NCT01967277|E2|Reported Event|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
40032|NCT01967277|E1|Reported Event|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
40033|NCT01967147|B3|Baseline|Total|Total of all reporting groups
40034|NCT01967147|B2|Baseline|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40035|NCT01967147|B1|Baseline|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40036|NCT01967147|P2|Participant Flow|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40037|NCT01967147|P1|Participant Flow|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40038|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40039|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40040|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40041|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40042|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40043|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40044|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40045|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40046|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40047|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
40048|NCT01967147|E3|Reported Event|Saline|All subjects exposed to Saline
40049|NCT01967147|E2|Reported Event|Systane Balance|All subjects exposed to Systane® Balance
40050|NCT01967147|E1|Reported Event|Pretreatment|All subjects prior to exposure to investigational product
40051|NCT01967121|B4|Baseline|Total|Total of all reporting groups
40052|NCT01967121|B3|Baseline|Control|This is a control group where subjects will not perform an intervention.
40053|NCT01967121|B2|Baseline|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
40054|NCT01967121|B1|Baseline|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
40055|NCT01967121|P3|Participant Flow|Control|This is a control group where subjects will not perform an intervention.
40056|NCT01967121|P2|Participant Flow|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
40057|NCT01967121|P1|Participant Flow|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
40058|NCT01967121|O3|Outcome|Control|This is a control group where subjects will not perform an intervention.
40059|NCT01967121|O2|Outcome|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
40060|NCT01967121|O1|Outcome|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
40062|NCT01967121|E2|Reported Event|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
40063|NCT01967121|E1|Reported Event|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
40064|NCT01966926|B3|Baseline|Total|Total of all reporting groups
40065|NCT01966926|B2|Baseline|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40066|NCT01966926|B1|Baseline|Daily Weight Tracking|daily weighing frequency instructions and tips
40067|NCT01966926|P2|Participant Flow|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40068|NCT01966926|P1|Participant Flow|Daily Weight Tracking|daily weighing frequency instructions and tips
40069|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40070|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40071|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40072|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40073|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40074|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40075|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40076|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40077|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40078|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40079|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40080|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
40081|NCT01966926|E2|Reported Event|Weekly Weight Tracking|weekly weighing frequency instructions and tips
40082|NCT01966926|E1|Reported Event|Daily Weight Tracking|daily weighing frequency instructions and tips
40083|NCT01966770|B1|Baseline|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
40084|NCT01966770|P1|Participant Flow|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
40085|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40086|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40087|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40088|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40089|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40090|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40091|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40092|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40093|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40094|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40095|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40096|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40097|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40098|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40099|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40100|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
40101|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
40102|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40103|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
41018|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
40106|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40107|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40108|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40109|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40110|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40111|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40112|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40113|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40114|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40115|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40116|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40117|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40118|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40119|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40120|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40121|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40122|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40123|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40124|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40125|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40126|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40127|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40128|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40129|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40130|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40131|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40132|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40133|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40134|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40135|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40136|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40137|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40138|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40139|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
40140|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
40141|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
40142|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40143|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40144|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40145|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40146|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40147|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40148|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
40149|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
40150|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40151|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
40152|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
40153|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40154|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40155|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40156|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40157|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40158|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40159|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40160|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40161|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40162|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40163|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40164|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40165|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
40166|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40167|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40168|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40169|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40170|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40171|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40172|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40173|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
40174|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40175|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
40176|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40177|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
40178|NCT01966770|O7|Outcome|F55 ASPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
40654|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40179|NCT01966770|O6|Outcome|F55 SPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
40180|NCT01966770|O5|Outcome|PCM SPHERE LENS|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
40181|NCT01966770|O4|Outcome|AV SPHERE LENS|Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
40182|NCT01966770|O3|Outcome|BF SPHERE LENS|Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
40183|NCT01966770|O2|Outcome|B55 SPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
40184|NCT01966770|O1|Outcome|B55 PREMIER ASPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
40185|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
40186|NCT01966770|E6|Reported Event|Pair 6 (Omafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
40187|NCT01966770|E5|Reported Event|Pair 5 (Methafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
40188|NCT01966770|E4|Reported Event|Pair 4 (Methafilcon A / Methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
40189|NCT01966770|E3|Reported Event|Pair 3 (Ocufilcon D / Comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
40190|NCT01966770|E2|Reported Event|Pair 2 (Ocufilcon D / Enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
40191|NCT01966770|E1|Reported Event|Pair 1 (Ocufilcon D / Ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
40192|NCT01966718|B1|Baseline|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40193|NCT01966718|P1|Participant Flow|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40194|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40195|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40196|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40197|NCT01966718|O2|Outcome|Tender Joints|Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
40198|NCT01966718|O1|Outcome|Swollen Joints|Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).
40199|NCT01966718|E1|Reported Event|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
40200|NCT01966380|B1|Baseline|Leia and Hydroactive Surgical Dressing|In the case of this study, participants served as their own control.
40201|NCT01966380|P2|Participant Flow|Cross-over Assignment Hydroactive Surgical Dressing|First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
40202|NCT01966380|P1|Participant Flow|Cross-over Assignment Leia|First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.
40203|NCT01966380|O2|Outcome|Hydroactivate Surgical Dressing|Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
40204|NCT01966380|O1|Outcome|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
40205|NCT01966380|E2|Reported Event|Hydroactive Surgical Dressing|"Intervention: Device: Hydroactive surgical dressing~Cross-over design, the patient was his own controll. 6 patients were treated in total."
40206|NCT01966380|E1|Reported Event|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
40207|NCT01966354|B4|Baseline|Total|Total of all reporting groups
40290|NCT01965938|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40807|NCT01964352|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40208|NCT01966354|B3|Baseline|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40209|NCT01966354|B2|Baseline|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40210|NCT01966354|B1|Baseline|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40211|NCT01966354|P3|Participant Flow|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40212|NCT01966354|P2|Participant Flow|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40213|NCT01966354|P1|Participant Flow|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40214|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40215|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40291|NCT01965938|P1|Participant Flow|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40655|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
41019|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
40216|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40217|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40218|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40219|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40220|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40221|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40222|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40223|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40292|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40808|NCT01964352|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40224|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40225|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40226|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40227|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40228|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40229|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40230|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40231|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40293|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40809|NCT01964352|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40232|NCT01966354|E3|Reported Event|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40233|NCT01966354|E2|Reported Event|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40234|NCT01966354|E1|Reported Event|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
40235|NCT01966159|B3|Baseline|Total|Total of all reporting groups
40236|NCT01966159|B2|Baseline|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40237|NCT01966159|B1|Baseline|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40238|NCT01966159|P2|Participant Flow|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40239|NCT01966159|P1|Participant Flow|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40240|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40241|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40242|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40243|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40244|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40245|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40246|NCT01966159|E2|Reported Event|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
40247|NCT01966159|E1|Reported Event|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
40248|NCT01966120|B3|Baseline|Total|Total of all reporting groups
40249|NCT01966120|B2|Baseline|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40250|NCT01966120|B1|Baseline|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40294|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40295|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40656|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40251|NCT01966120|P2|Participant Flow|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40252|NCT01966120|P1|Participant Flow|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the investigational medicinal product (IMP) was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40253|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40254|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40255|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40256|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40257|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40258|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40657|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40259|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40260|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40261|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40262|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40263|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40264|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40265|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40266|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40658|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
94258|NCT01628848|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
40267|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40268|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40269|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40270|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40271|NCT01966120|E2|Reported Event|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40272|NCT01966120|E1|Reported Event|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
40273|NCT01966068|B3|Baseline|Total|Total of all reporting groups
40274|NCT01966068|B2|Baseline|MyAsthma Web Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
40275|NCT01966068|B1|Baseline|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
40276|NCT01966068|P1|Participant Flow|MyAsthma Web Portal|The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
40277|NCT01966068|O2|Outcome|MyAsthma Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
40278|NCT01966068|O1|Outcome|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
40279|NCT01966068|E1|Reported Event|MyAsthma Web Portal|"The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.~MyAsthma Web Portal"
40296|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
41020|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41021|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
40280|NCT01966042|B1|Baseline|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40281|NCT01966042|P1|Participant Flow|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion.~Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40282|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40283|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40284|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40285|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40286|NCT01966042|E1|Reported Event|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
40287|NCT01965938|B3|Baseline|Total|Total of all reporting groups
40288|NCT01965938|B2|Baseline|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40289|NCT01965938|B1|Baseline|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
41022|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
40297|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40298|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40299|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40300|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40301|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40302|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40303|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40304|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40305|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
40306|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40307|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40308|NCT01965938|E2|Reported Event|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40309|NCT01965938|E1|Reported Event|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
40310|NCT01965899|B1|Baseline|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40311|NCT01965899|P1|Participant Flow|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40312|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40313|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40314|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.
41023|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
41024|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
40315|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40316|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40317|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40318|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40319|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40320|NCT01965899|E1|Reported Event|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
40321|NCT01965665|B1|Baseline|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40322|NCT01965665|P1|Participant Flow|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40323|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40324|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40325|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40326|NCT01965665|E1|Reported Event|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
40327|NCT01965600|B1|Baseline|All Participants|Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
40328|NCT01965600|P4|Participant Flow|Placebo Followed by PF-06282999 500 mg BID|Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
40329|NCT01965600|P3|Participant Flow|PF-06282999 500 mg BID Followed by Placebo|Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
40330|NCT01965600|P2|Participant Flow|Placebo Followed by PF-06282999 125 mg TID|Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
40331|NCT01965600|P1|Participant Flow|PF-06282999 125 mg TID Followed by Placebo|Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
41025|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
40332|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40333|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40334|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40335|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40336|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40337|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40338|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40339|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40340|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40341|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40342|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40343|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40344|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40345|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40346|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40347|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40348|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40349|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40350|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40351|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40352|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40353|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40354|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40355|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40356|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40357|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40358|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40359|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40360|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40361|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40362|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40363|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
41026|NCT01962922|E2|Reported Event|Tacrolimus - IR|brand IR tacrolimus
40364|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40365|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40366|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40367|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40368|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40369|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40370|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40371|NCT01965600|E3|Reported Event|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
40372|NCT01965600|E2|Reported Event|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
40373|NCT01965600|E1|Reported Event|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
40374|NCT01965561|B1|Baseline|Junctional Tourniquet Use|"Junctional tourniquet use followed by rest, repeat~Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice."
40375|NCT01965561|P1|Participant Flow|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
40376|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
40377|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
40378|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
40379|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
40380|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
40381|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
40382|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
40383|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
40384|NCT01965561|E1|Reported Event|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
40385|NCT01965535|B3|Baseline|Total|Total of all reporting groups
40386|NCT01965535|B2|Baseline|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40387|NCT01965535|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40388|NCT01965535|P2|Participant Flow|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40389|NCT01965535|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
40659|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40390|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40391|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40392|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40393|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40394|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40395|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40396|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40397|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40398|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40399|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40400|NCT01965535|E2|Reported Event|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
40401|NCT01965535|E1|Reported Event|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
40402|NCT01965431|B1|Baseline|Overall Study|This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
40403|NCT01965431|P6|Participant Flow|R2/R1/T|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40404|NCT01965431|P5|Participant Flow|R2/T/R1|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40405|NCT01965431|P4|Participant Flow|R1/R2/T|Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40406|NCT01965431|P3|Participant Flow|R1/T/R2|Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40660|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
94259|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
40407|NCT01965431|P2|Participant Flow|T/R2/R1|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40408|NCT01965431|P1|Participant Flow|T/R1/R2|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
40409|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40410|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40411|NCT01965431|O2|Outcome|Placebo to BI 207127) + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40412|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40413|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40414|NCT01965431|O1|Outcome|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.
40415|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40416|NCT01965431|O1|Outcome|BI 207127+ Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
40417|NCT01965431|E3|Reported Event|Placebo (BI 207127) + Placebo (Faldaprevir)|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
40418|NCT01965431|E2|Reported Event|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
40419|NCT01965431|E1|Reported Event|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
40420|NCT01965327|B1|Baseline|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
40421|NCT01965327|P1|Participant Flow|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
40422|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
40445|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40661|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40423|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
40424|NCT01965327|E1|Reported Event|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
40425|NCT01965288|B3|Baseline|Total|Total of all reporting groups
40426|NCT01965288|B2|Baseline|Lotrafilcon B Then Comfilcon A|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40427|NCT01965288|B1|Baseline|Comfilcon A Then Lotrafilcon B|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40428|NCT01965288|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40429|NCT01965288|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40430|NCT01965288|O3|Outcome|Neither|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40431|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40432|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40433|NCT01965288|O3|Outcome|Habitual|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40434|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40435|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40436|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40437|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40438|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40439|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40440|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40441|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40442|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40443|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40444|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
41027|NCT01962922|E1|Reported Event|Envarsus XR|Tacrolimus extended release
40446|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40447|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40448|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40449|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40450|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40451|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40452|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40453|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40454|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40455|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40456|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
40457|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40458|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40459|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40460|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40461|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40462|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40463|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40464|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40465|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40466|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40467|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40468|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40469|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
40470|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40471|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40472|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40473|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40474|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
40475|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40476|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40477|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40478|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40479|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
40480|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40481|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40482|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40483|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40484|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
40485|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40486|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40487|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40488|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40489|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40490|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40491|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40492|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40493|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40494|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40495|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40653|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40496|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40497|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40498|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40499|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40500|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40501|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40502|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40503|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40504|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40505|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40506|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40507|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40508|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40509|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40510|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40511|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40512|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40513|NCT01965288|O2|Outcome|Lotrafilcon B|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
40514|NCT01965288|O1|Outcome|Comfilcon A|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
40515|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40516|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40517|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40518|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40519|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40520|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40521|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40522|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40523|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40524|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40525|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40526|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40527|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40528|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40529|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40530|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40531|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40532|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40533|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40534|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40535|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40536|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40537|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40538|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
40539|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40540|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40541|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40542|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40543|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40544|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40545|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40546|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40547|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40548|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40549|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40550|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40551|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40552|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40553|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40554|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40555|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40556|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40557|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40558|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40559|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40560|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
40561|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40562|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40563|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40564|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40565|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40566|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40567|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40568|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40569|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40570|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40571|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40572|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
40573|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40574|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40575|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
40576|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40577|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40578|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40579|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40580|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40581|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40582|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40583|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40584|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40585|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40586|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40587|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40588|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40589|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40590|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40591|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40592|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40593|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40594|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40595|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40596|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40597|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40598|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40599|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40600|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40601|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40602|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40603|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40604|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40605|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40606|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40607|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40608|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40609|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40610|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40611|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40612|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40613|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40614|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40615|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40616|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40617|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40618|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40619|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40620|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40621|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40622|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40623|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40624|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40625|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40626|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40627|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40628|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40629|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40630|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects after removal of habitual lens and prior to dispense of study lens.
40631|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
40632|NCT01965288|E2|Reported Event|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
40633|NCT01965288|E1|Reported Event|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
40634|NCT01965262|B1|Baseline|Overall Baseline Characteristics|"Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair~Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair~etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair"
40635|NCT01965262|P2|Participant Flow|Etafilcon A Lens, Then Hema-copoloymer Lens|Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
40636|NCT01965262|P1|Participant Flow|Hema-copolymer Lens, Then Etafilcon A Lens|Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
40637|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40638|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40639|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40640|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40641|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40642|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40643|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40644|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40645|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40646|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40647|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40648|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40649|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40650|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40651|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40652|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
41028|NCT01962675|B3|Baseline|Total|Total of all reporting groups
94260|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
40662|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40663|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40664|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40665|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40666|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40667|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40668|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40669|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40670|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40671|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40672|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40673|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40674|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40675|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40676|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40677|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40678|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40679|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40680|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40681|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40682|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40683|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40684|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40685|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40686|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40687|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40688|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40689|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40690|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40691|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40692|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40693|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40694|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40695|NCT01965262|E2|Reported Event|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
40696|NCT01965262|E1|Reported Event|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
40697|NCT01965067|B3|Baseline|Total|Total of all reporting groups
40698|NCT01965067|B2|Baseline|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
41263|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
40699|NCT01965067|B1|Baseline|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40700|NCT01965067|P2|Participant Flow|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40701|NCT01965067|P1|Participant Flow|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40702|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40703|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40704|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40705|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40706|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40707|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40708|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40709|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40710|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40711|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40712|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40713|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40714|NCT01965067|E2|Reported Event|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40715|NCT01965067|E1|Reported Event|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
40716|NCT01964898|B3|Baseline|Total|Total of all reporting groups
40717|NCT01964898|B2|Baseline|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40718|NCT01964898|B1|Baseline|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40719|NCT01964898|P2|Participant Flow|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40742|NCT01964716|P2|Participant Flow|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40810|NCT01964352|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40720|NCT01964898|P1|Participant Flow|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40721|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40722|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40723|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40724|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40725|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40726|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40727|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40728|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40729|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40730|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40731|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40732|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40733|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40734|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40735|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40736|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40737|NCT01964898|E2|Reported Event|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
40738|NCT01964898|E1|Reported Event|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
40739|NCT01964716|B3|Baseline|Total|Total of all reporting groups
40740|NCT01964716|B2|Baseline|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40741|NCT01964716|B1|Baseline|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40743|NCT01964716|P1|Participant Flow|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40744|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40745|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40746|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40747|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40748|NCT01964716|O3|Outcome|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
40749|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40750|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40751|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40752|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40753|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40754|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40755|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40756|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40757|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40758|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40759|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40760|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40761|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40762|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40763|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40764|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40765|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40766|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40767|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
40768|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
40769|NCT01964716|E9|Reported Event|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
40770|NCT01964716|E8|Reported Event|13vPnC SDS: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
41264|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
40771|NCT01964716|E7|Reported Event|13vPnC MDV: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
40772|NCT01964716|E6|Reported Event|13vPnC SDS: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
40773|NCT01964716|E5|Reported Event|13vPnC MDV: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
40774|NCT01964716|E4|Reported Event|13vPnC SDS: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
40775|NCT01964716|E3|Reported Event|13vPnC MDV: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
40776|NCT01964716|E2|Reported Event|13vPnC SDS: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
40777|NCT01964716|E1|Reported Event|13vPnC MDV: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
40778|NCT01964547|B3|Baseline|Total|Total of all reporting groups
40779|NCT01964547|B2|Baseline|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40780|NCT01964547|B1|Baseline|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40781|NCT01964547|P2|Participant Flow|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40782|NCT01964547|P1|Participant Flow|Sativex|Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40783|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40784|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40785|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40786|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40787|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40788|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40789|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40790|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40791|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40792|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40793|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40794|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40795|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40796|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40797|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40798|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40799|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40800|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40801|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40802|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40803|NCT01964547|E2|Reported Event|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
40804|NCT01964547|E1|Reported Event|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
40805|NCT01964352|B5|Baseline|Total|Total of all reporting groups
41265|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
40811|NCT01964352|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40812|NCT01964352|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40813|NCT01964352|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40814|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40815|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40816|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40817|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40818|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40819|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40820|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40821|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40822|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40823|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40824|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40825|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40826|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40827|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40828|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40829|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40830|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40831|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40832|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40833|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40834|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40835|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40836|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40837|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40838|NCT01964352|E4|Reported Event|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40839|NCT01964352|E3|Reported Event|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
40840|NCT01964352|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
40841|NCT01964352|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
40842|NCT01964326|B1|Baseline|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40843|NCT01964326|P1|Participant Flow|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40844|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40845|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40846|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40847|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40848|NCT01964326|E1|Reported Event|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
40849|NCT01964222|B3|Baseline|Total|Total of all reporting groups
40850|NCT01964222|B2|Baseline|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40851|NCT01964222|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40852|NCT01964222|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40918|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
94261|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
40853|NCT01964222|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40854|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40855|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40856|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40857|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40858|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40859|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40860|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40861|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40862|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40863|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40864|NCT01964222|E2|Reported Event|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
40865|NCT01964222|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
40866|NCT01963845|B3|Baseline|Total|Total of all reporting groups
40867|NCT01963845|B2|Baseline|Active Drug|Sitagliptin 100 mg
40868|NCT01963845|B1|Baseline|Placebo|Sitagliptin-matched placebo tablet
40869|NCT01963845|P2|Participant Flow|Active Drug|Sitagliptin 100 mg
40870|NCT01963845|P1|Participant Flow|Placebo|Sitagliptin-matched placebo tablet
40871|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
40872|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
40873|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
40874|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
40875|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
40876|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
40877|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
40878|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
40879|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
40880|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
40881|NCT01963845|E2|Reported Event|Active Drug|Sitagliptin 100 mg
40882|NCT01963845|E1|Reported Event|Placebo|Sitagliptin-matched placebo tablet
40883|NCT01963767|B3|Baseline|Total|Total of all reporting groups
40884|NCT01963767|B2|Baseline|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
40885|NCT01963767|B1|Baseline|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
40886|NCT01963767|P2|Participant Flow|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
40887|NCT01963767|P1|Participant Flow|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
40888|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
40919|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40920|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40921|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40922|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40889|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
40890|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
40891|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
40892|NCT01963767|E2|Reported Event|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
40893|NCT01963767|E1|Reported Event|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
40894|NCT01963676|B3|Baseline|Total|Total of all reporting groups
40895|NCT01963676|B2|Baseline|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
40896|NCT01963676|B1|Baseline|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
40897|NCT01963676|P2|Participant Flow|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
40898|NCT01963676|P1|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
40899|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
40900|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
40901|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
40902|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
40903|NCT01963676|E2|Reported Event|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
40904|NCT01963676|E1|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
40905|NCT01963611|B6|Baseline|Total|Total of all reporting groups
40906|NCT01963611|B5|Baseline|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40907|NCT01963611|B4|Baseline|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40908|NCT01963611|B3|Baseline|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40909|NCT01963611|B2|Baseline|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40910|NCT01963611|B1|Baseline|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40911|NCT01963611|P5|Participant Flow|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40912|NCT01963611|P4|Participant Flow|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40913|NCT01963611|P3|Participant Flow|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40914|NCT01963611|P2|Participant Flow|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40915|NCT01963611|P1|Participant Flow|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40916|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40917|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40961|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40923|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40924|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40925|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40926|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40927|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40928|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40929|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40930|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40931|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months
40932|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40933|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40934|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40935|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40936|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40937|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40938|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40939|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40940|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40941|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40942|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40943|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40944|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40945|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40946|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40947|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40948|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40949|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40950|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40951|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40952|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40953|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40954|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40955|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40956|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
40957|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40958|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40959|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40960|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
41015|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
40962|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
40963|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40964|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40965|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
40966|NCT01963611|E5|Reported Event|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
40967|NCT01963611|E4|Reported Event|Plovamer Acetate 20 mg|Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
40968|NCT01963611|E3|Reported Event|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
40969|NCT01963611|E2|Reported Event|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
40970|NCT01963611|E1|Reported Event|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
40971|NCT01963091|B3|Baseline|Total|Total of all reporting groups
40972|NCT01963091|B2|Baseline|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40973|NCT01963091|B1|Baseline|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40974|NCT01963091|P2|Participant Flow|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40975|NCT01963091|P1|Participant Flow|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40976|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40977|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40978|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40979|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40980|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40981|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40982|NCT01963091|E2|Reported Event|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40983|NCT01963091|E1|Reported Event|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
40984|NCT01962961|B4|Baseline|Total|Total of all reporting groups
40985|NCT01962961|B3|Baseline|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40986|NCT01962961|B2|Baseline|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
40987|NCT01962961|B1|Baseline|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40988|NCT01962961|P3|Participant Flow|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40989|NCT01962961|P2|Participant Flow|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
40990|NCT01962961|P1|Participant Flow|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40991|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40992|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
40993|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40994|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
41016|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41017|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
40995|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
40996|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40997|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
40998|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
40999|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
41000|NCT01962961|E3|Reported Event|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
41001|NCT01962961|E2|Reported Event|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
41002|NCT01962961|E1|Reported Event|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
41003|NCT01962922|B3|Baseline|Total|Total of all reporting groups
41004|NCT01962922|B2|Baseline|Sequence II|Sequence II Envarsus XR→IR-Tac (N = 23)
41005|NCT01962922|B1|Baseline|Sequence I|Sequence I IR-Tac→Envarsus XR (N = 27)
41006|NCT01962922|P2|Participant Flow|Sequence 2|"• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1–7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.~Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months."
41007|NCT01962922|P1|Participant Flow|Sequence 1|"•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1–7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.~Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months."
41008|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41009|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
41010|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41011|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
41012|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41013|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
41014|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
41029|NCT01962675|B2|Baseline|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
41030|NCT01962675|B1|Baseline|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
41031|NCT01962675|P2|Participant Flow|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
41032|NCT01962675|P1|Participant Flow|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
41033|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
41034|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
41035|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
41036|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
41037|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41038|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41039|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41078|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
94262|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
41040|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41041|NCT01962675|E2|Reported Event|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41042|NCT01962675|E1|Reported Event|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
41043|NCT01962493|B3|Baseline|Total|Total of all reporting groups
41044|NCT01962493|B2|Baseline|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41045|NCT01962493|B1|Baseline|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41046|NCT01962493|P2|Participant Flow|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41047|NCT01962493|P1|Participant Flow|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41048|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41049|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41050|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41051|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41052|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41053|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41054|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41055|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41079|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41056|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41057|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41058|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41059|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41060|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41061|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41062|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41063|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41064|NCT01962493|E2|Reported Event|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41065|NCT01962493|E1|Reported Event|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
41066|NCT01962441|B4|Baseline|Total|Total of all reporting groups
41067|NCT01962441|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41068|NCT01962441|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41069|NCT01962441|B1|Baseline|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41070|NCT01962441|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks
41071|NCT01962441|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41072|NCT01962441|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41073|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41074|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41075|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41076|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41077|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
94263|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
41080|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41081|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41082|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41083|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41084|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41085|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41086|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41087|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41088|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41089|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41090|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41091|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41092|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41093|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41094|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41095|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41096|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41097|NCT01962441|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
41098|NCT01962441|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
41099|NCT01962441|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
41100|NCT01962428|B3|Baseline|Total|Total of all reporting groups
41101|NCT01962428|B2|Baseline|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41102|NCT01962428|B1|Baseline|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41103|NCT01962428|P2|Participant Flow|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41104|NCT01962428|P1|Participant Flow|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41105|NCT01962428|O2|Outcome|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41106|NCT01962428|O1|Outcome|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41107|NCT01962428|E2|Reported Event|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41108|NCT01962428|E1|Reported Event|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
41109|NCT01961544|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
41110|NCT01961544|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
41111|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
41112|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
41113|NCT01961544|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
41114|NCT01961349|B4|Baseline|Total|Total of all reporting groups
41115|NCT01961349|B3|Baseline|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
41116|NCT01961349|B2|Baseline|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
41117|NCT01961349|B1|Baseline|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
41118|NCT01961349|P3|Participant Flow|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
41119|NCT01961349|P2|Participant Flow|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
41120|NCT01961349|P1|Participant Flow|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
41121|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
41122|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
41123|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
41124|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
41125|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
41126|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
41127|NCT01961349|E3|Reported Event|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
41128|NCT01961349|E2|Reported Event|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
41129|NCT01961349|E1|Reported Event|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
41130|NCT01961271|B1|Baseline|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41131|NCT01961271|P1|Participant Flow|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41132|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41133|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41134|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41135|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41136|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41137|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41138|NCT01961271|E1|Reported Event|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
41139|NCT01960907|B3|Baseline|Total|Total of all reporting groups
41140|NCT01960907|B2|Baseline|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
41141|NCT01960907|B1|Baseline|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
41177|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41142|NCT01960907|P2|Participant Flow|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
41143|NCT01960907|P1|Participant Flow|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
41144|NCT01960907|O2|Outcome|Observational, Previously Hopitalized for COPD Exacerb.|Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
41145|NCT01960907|O1|Outcome|Monitored, Previously Hopitalized for COPD Exacerbation|Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
41146|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
41147|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
41148|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
41149|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
41150|NCT01960907|E2|Reported Event|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
41151|NCT01960907|E1|Reported Event|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
41152|NCT01960842|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41153|NCT01960842|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41154|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41155|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41178|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41266|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41156|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41157|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41158|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41159|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41160|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41161|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41162|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41163|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41164|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41165|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41258|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41259|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41166|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41167|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41168|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41169|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41170|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41171|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41172|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41173|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41174|NCT01960842|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
41175|NCT01960816|B1|Baseline|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41176|NCT01960816|P1|Participant Flow|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41260|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41179|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41180|NCT01960816|E1|Reported Event|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
41181|NCT01960400|B3|Baseline|Total|Total of all reporting groups
41182|NCT01960400|B2|Baseline|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
41183|NCT01960400|B1|Baseline|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
41184|NCT01960400|P2|Participant Flow|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
41185|NCT01960400|P1|Participant Flow|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
41186|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41187|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41188|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41189|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41190|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41191|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41261|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41262|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41192|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41193|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
41194|NCT01960400|E2|Reported Event|GMI + Placebo tDCS|Graded motor imagery (GMI) + placebo tDCS
41195|NCT01960400|E1|Reported Event|GMI + Active tDCS|Graded motor imagery (GMI) + active tDCS
41196|NCT01960387|B1|Baseline|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41197|NCT01960387|P1|Participant Flow|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41198|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41199|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41200|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41201|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
41202|NCT01960387|E1|Reported Event|Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)|Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
41203|NCT01960114|B3|Baseline|Total|Total of all reporting groups
41204|NCT01960114|B2|Baseline|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41205|NCT01960114|B1|Baseline|Placebo|Placebo (two matching placebo tablets)
41206|NCT01960114|P2|Participant Flow|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41207|NCT01960114|P1|Participant Flow|Placebo|Placebo (two matching placebo tablets)
41208|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41209|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
41210|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41211|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
41212|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41213|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
41214|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41215|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
41216|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41217|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
41218|NCT01960114|E2|Reported Event|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
41219|NCT01960114|E1|Reported Event|Placebo|Placebo (two matching placebo tablets)
41220|NCT01959945|B5|Baseline|Total|Total of all reporting groups
41221|NCT01959945|B4|Baseline|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41222|NCT01959945|B3|Baseline|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41223|NCT01959945|B2|Baseline|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41224|NCT01959945|B1|Baseline|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41225|NCT01959945|P4|Participant Flow|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41226|NCT01959945|P3|Participant Flow|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41227|NCT01959945|P2|Participant Flow|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41228|NCT01959945|P1|Participant Flow|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41229|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41230|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41231|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41232|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41233|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41234|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41235|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41236|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41237|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41238|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41239|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41240|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41241|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41242|NCT01959945|O3|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41243|NCT01959945|O2|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41244|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41245|NCT01959945|E4|Reported Event|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41246|NCT01959945|E3|Reported Event|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41247|NCT01959945|E2|Reported Event|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41248|NCT01959945|E1|Reported Event|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
41249|NCT01959932|B4|Baseline|Total|Total of all reporting groups
41250|NCT01959932|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41251|NCT01959932|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41252|NCT01959932|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41253|NCT01959932|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41254|NCT01959932|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41255|NCT01959932|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41256|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41257|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41267|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41268|NCT01959932|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
41269|NCT01959932|E3|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
41270|NCT01959932|E2|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
41271|NCT01959932|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
41272|NCT01959880|B5|Baseline|Total|Total of all reporting groups
41273|NCT01959880|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41274|NCT01959880|B3|Baseline|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41275|NCT01959880|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41276|NCT01959880|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41277|NCT01959880|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41278|NCT01959880|P3|Participant Flow|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41279|NCT01959880|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41280|NCT01959880|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41281|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41282|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41283|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41284|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41285|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41286|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41287|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41288|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41289|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41290|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41291|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41292|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41293|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41294|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41295|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41327|NCT01959503|B3|Baseline|Total|Total of all reporting groups
41296|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41297|NCT01959880|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
41298|NCT01959880|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
41299|NCT01959880|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
41300|NCT01959880|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
41301|NCT01959685|B1|Baseline|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
41302|NCT01959685|P1|Participant Flow|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
41303|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
41304|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
41305|NCT01959685|E1|Reported Event|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
41306|NCT01959607|B3|Baseline|Total|Total of all reporting groups
41307|NCT01959607|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
41308|NCT01959607|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
41309|NCT01959607|P4|Participant Flow|NRT Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT gum [Nicorette ® 2mg])~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
41310|NCT01959607|P3|Participant Flow|THS 2.2 Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT gum [Nicorette ® 2mg])."
41311|NCT01959607|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
41312|NCT01959607|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
41313|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2."
41314|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
41315|NCT01959607|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
41316|NCT01959607|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
41317|NCT01959607|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
41318|NCT01959516|B1|Baseline|All Participants (Intent To Treat Analysis,ITT)|All participants who were randomized to one of the two treatment sequences in a ratio of 1:1. Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days.
41319|NCT01959516|P2|Participant Flow|Tiotropium First, Then Glycopyrronium|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
41320|NCT01959516|P1|Participant Flow|"Glycopyrronium First, Then Tiotropium"|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
41321|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
41322|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
41323|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
41324|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
41325|NCT01959516|E2|Reported Event|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
41326|NCT01959516|E1|Reported Event|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
41328|NCT01959503|B2|Baseline|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41329|NCT01959503|B1|Baseline|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41330|NCT01959503|P2|Participant Flow|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41331|NCT01959503|P1|Participant Flow|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41332|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41333|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41334|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41335|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41336|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41337|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41338|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41339|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41340|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41341|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41342|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41343|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41344|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41345|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41346|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41347|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41348|NCT01959503|E2|Reported Event|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
41349|NCT01959503|E1|Reported Event|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
41350|NCT01959412|B1|Baseline|All Participants|All participants randomized to one of six treatment sequences
41351|NCT01959412|P6|Participant Flow|Sequence 6 (Placebo)|Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41352|NCT01959412|P5|Participant Flow|Sequence 5 (Ind 27.5 μg)|indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41353|NCT01959412|P4|Participant Flow|Sequence 1 (Ind 37.5 μg)|indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41354|NCT01959412|P3|Participant Flow|Sequence 2 (Ind 55 μg)|indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41355|NCT01959412|P2|Participant Flow|Sequence 3 (Ind 75 μg)|indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41416|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41417|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
94264|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
41356|NCT01959412|P1|Participant Flow|Sequence 4 (Ind 150 μg)|indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41357|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41358|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41359|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41360|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41361|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41362|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41363|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41364|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41365|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41366|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41367|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41368|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41369|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41370|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
42665|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
41371|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41372|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41373|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41374|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41375|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41376|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41377|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41378|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41379|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41380|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41381|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41382|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41383|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41384|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41385|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41418|NCT01959035|E1|Reported Event|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41386|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41387|NCT01959412|E6|Reported Event|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
41388|NCT01959412|E5|Reported Event|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
41389|NCT01959412|E4|Reported Event|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
41390|NCT01959412|E3|Reported Event|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
41391|NCT01959412|E2|Reported Event|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
41392|NCT01959412|E1|Reported Event|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
41393|NCT01959035|B1|Baseline|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41394|NCT01959035|P1|Participant Flow|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
41395|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41396|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41397|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41398|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41399|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41400|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41401|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41402|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41403|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41404|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41405|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41406|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41407|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41408|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41409|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41410|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41411|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41412|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41413|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41414|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41415|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
41419|NCT01958827|B1|Baseline|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41420|NCT01958827|P1|Participant Flow|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41421|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41422|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41423|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41424|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41425|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41426|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41427|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41428|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41429|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41430|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41431|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41432|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41433|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41434|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41435|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41436|NCT01958827|E1|Reported Event|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
41437|NCT01958788|B1|Baseline|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
41438|NCT01958788|P1|Participant Flow|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41439|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41440|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41441|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41442|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41443|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41444|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41445|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
41446|NCT01958788|E1|Reported Event|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
41447|NCT01958645|B4|Baseline|Total|Total of all reporting groups
41448|NCT01958645|B3|Baseline|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41449|NCT01958645|B2|Baseline|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41450|NCT01958645|B1|Baseline|Placebo|Placebo (Saline solution for infusion)
41451|NCT01958645|P3|Participant Flow|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41452|NCT01958645|P2|Participant Flow|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41453|NCT01958645|P1|Participant Flow|Placebo|Placebo (Saline solution for infusion)
41454|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
41455|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41456|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41457|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
41458|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
41459|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41460|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41461|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
41462|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
41618|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
41463|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41464|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41465|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
41466|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
41467|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41468|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41469|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
41470|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41471|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41472|NCT01958645|O1|Outcome|Placebo|Placebo (Saline solution for infusion)
41473|NCT01958645|E3|Reported Event|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
41474|NCT01958645|E2|Reported Event|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
41475|NCT01958645|E1|Reported Event|Placebo|Placebo (Saline solution for infusion)
41476|NCT01958619|B5|Baseline|Total|Total of all reporting groups
41477|NCT01958619|B4|Baseline|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41478|NCT01958619|B3|Baseline|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41479|NCT01958619|B2|Baseline|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41480|NCT01958619|B1|Baseline|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41481|NCT01958619|P4|Participant Flow|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41482|NCT01958619|P3|Participant Flow|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41483|NCT01958619|P2|Participant Flow|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41484|NCT01958619|P1|Participant Flow|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41485|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41486|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41487|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41488|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41489|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41490|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41491|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41492|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41493|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41494|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41495|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41496|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41497|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41498|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41499|NCT01958619|E4|Reported Event|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41500|NCT01958619|E3|Reported Event|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41501|NCT01958619|E2|Reported Event|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41502|NCT01958619|E1|Reported Event|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
41503|NCT01958346|B3|Baseline|Total|Total of all reporting groups
41504|NCT01958346|B2|Baseline|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
41667|NCT01957475|E2|Reported Event|Test Z|Results from the subjects testing Coloplast Test Y
41505|NCT01958346|B1|Baseline|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
41506|NCT01958346|P2|Participant Flow|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
41507|NCT01958346|P1|Participant Flow|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
41508|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
41509|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
41510|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
41511|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
41512|NCT01958346|E2|Reported Event|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
41513|NCT01958346|E1|Reported Event|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
41514|NCT01958164|B3|Baseline|Total|Total of all reporting groups
41515|NCT01958164|B2|Baseline|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41516|NCT01958164|B1|Baseline|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41517|NCT01958164|P2|Participant Flow|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41518|NCT01958164|P1|Participant Flow|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41519|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41520|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41521|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41522|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41523|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41524|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41525|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41526|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41527|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41528|NCT01958164|E2|Reported Event|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
41529|NCT01958164|E1|Reported Event|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
41530|NCT01958060|B7|Baseline|Total|Total of all reporting groups
41531|NCT01958060|B6|Baseline|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41532|NCT01958060|B5|Baseline|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41533|NCT01958060|B4|Baseline|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41534|NCT01958060|B3|Baseline|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41535|NCT01958060|B2|Baseline|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41536|NCT01958060|B1|Baseline|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
41537|NCT01958060|P6|Participant Flow|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41538|NCT01958060|P5|Participant Flow|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41539|NCT01958060|P4|Participant Flow|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41540|NCT01958060|P3|Participant Flow|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41541|NCT01958060|P2|Participant Flow|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41542|NCT01958060|P1|Participant Flow|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
41543|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41544|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41545|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41546|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41547|NCT01958060|O1|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41548|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41549|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41550|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41551|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41552|NCT01958060|O6|Outcome|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41553|NCT01958060|O5|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41554|NCT01958060|O4|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41555|NCT01958060|O3|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41556|NCT01958060|O2|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41557|NCT01958060|O1|Outcome|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
41558|NCT01958060|E6|Reported Event|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41559|NCT01958060|E5|Reported Event|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41560|NCT01958060|E4|Reported Event|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41561|NCT01958060|E3|Reported Event|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41562|NCT01958060|E2|Reported Event|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
41563|NCT01958060|E1|Reported Event|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
41564|NCT01958008|B5|Baseline|Total|Total of all reporting groups
41565|NCT01958008|B4|Baseline|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41566|NCT01958008|B3|Baseline|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41567|NCT01958008|B2|Baseline|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41568|NCT01958008|B1|Baseline|Placebo|Oral administration of Placebo matching BI 113608
41569|NCT01958008|P4|Participant Flow|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41570|NCT01958008|P3|Participant Flow|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41571|NCT01958008|P2|Participant Flow|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41572|NCT01958008|P1|Participant Flow|Placebo|Oral administration of Placebo matching BI 113608
41573|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41574|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41575|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41576|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41577|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41578|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41668|NCT01957475|E1|Reported Event|Test Y|Results from the subjects testing Coloplast Test Y
41579|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41580|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41581|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41582|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41583|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41584|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41585|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41586|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41587|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41588|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41589|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41590|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41591|NCT01958008|O4|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
41592|NCT01958008|O3|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
41593|NCT01958008|O2|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
41594|NCT01958008|O1|Outcome|Placebo|Oral administration of Placebo matching BI 113608
41595|NCT01958008|E4|Reported Event|50 mg Bid|Oral administration of BI 113608 50 mg film coated tablets twice daily
41596|NCT01958008|E3|Reported Event|25 mg Bid|Oral administration of BI 113608 25 mg film coated tablets twice daily
41597|NCT01958008|E2|Reported Event|10 mg Bid|Oral administration of BI 113608 10 mg film coated tablets twice daily
41598|NCT01958008|E1|Reported Event|Placebo|Oral administration of Placebo matching BI 113608
41599|NCT01957930|B3|Baseline|Total|Total of all reporting groups
41600|NCT01957930|B2|Baseline|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
41601|NCT01957930|B1|Baseline|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
41602|NCT01957930|P2|Participant Flow|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
41603|NCT01957930|P1|Participant Flow|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
41604|NCT01957930|O2|Outcome|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
41605|NCT01957930|O1|Outcome|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
41606|NCT01957930|E2|Reported Event|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
41607|NCT01957930|E1|Reported Event|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
41608|NCT01957865|B4|Baseline|Total|Total of all reporting groups
41609|NCT01957865|B3|Baseline|Control|Real-time adherence monitoring only (no SMS)
41610|NCT01957865|B2|Baseline|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
41611|NCT01957865|B1|Baseline|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
41612|NCT01957865|P3|Participant Flow|Control|Real-time adherence monitoring only (no SMS)
41613|NCT01957865|P2|Participant Flow|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
41614|NCT01957865|P1|Participant Flow|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
41615|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
41616|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence"
41617|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
41619|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
41620|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
41621|NCT01957865|E3|Reported Event|Control|Real-time adherence monitoring only (no SMS)
41622|NCT01957865|E2|Reported Event|Triggered SMS, Real-time Monitoring|"Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
41623|NCT01957865|E1|Reported Event|Fixed SMS, Real-time Monitoring|"SMS were sent daily for one month, then weekly for two months. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
41624|NCT01957761|B1|Baseline|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
41625|NCT01957761|P1|Participant Flow|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
41626|NCT01957761|O1|Outcome|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
41627|NCT01957761|E1|Reported Event|Clostridium Difficile Infection|
41628|NCT01957657|B1|Baseline|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41629|NCT01957657|P1|Participant Flow|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41630|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41631|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41632|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41633|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41634|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41635|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41636|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41669|NCT01957462|B1|Baseline|All Subjects|
94265|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
41637|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41638|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41639|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41640|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41641|NCT01957657|E1|Reported Event|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
41642|NCT01957553|B1|Baseline|All Subjects|baseline data are summarized for all subjects
41643|NCT01957553|P2|Participant Flow|Treatment Seqence 2; First SenSura the Coloplast Test Product|"Subjects first allocated to SenSura will after cross-over test Coloplast Test product~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
41644|NCT01957553|P1|Participant Flow|Treatment Sequence 1, First Coloplast Test Product, the SenSur|"Subjects first allocated to Coloplast Test product will after cross-over test SenSura~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
41645|NCT01957553|O2|Outcome|SenSura|
41646|NCT01957553|O1|Outcome|Coloplast Test Product|
41647|NCT01957553|E2|Reported Event|SenSura|Safety data for subjects exposed to SenSura
41648|NCT01957553|E1|Reported Event|Test Product|Safety data for subjects exposed to the test product
41649|NCT01957488|B1|Baseline|All Subjects|
41650|NCT01957488|P6|Participant Flow|Test 2/Test 1/SenSura|"The subjects in this group test the following in the order described below:~Test 2~Test 1~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
41651|NCT01957488|P5|Participant Flow|Test 2/SenSura/Test 1|"The subjects in this group test the following in the order described below:~Test 2~SenSura (the comparator)~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
41652|NCT01957488|P4|Participant Flow|Test 1/Test 2/SenSura|"The subjects in this group test the following in the order described below:~Test 1~Test 2~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
41653|NCT01957488|P3|Participant Flow|Test 1/SenSura/Test 2|"The subjects in this group test the following in the order described below:~Test 1~SenSura (the comparator)~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
41654|NCT01957488|P2|Participant Flow|SenSura/Test 2/Test 1|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 2~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
41655|NCT01957488|P1|Participant Flow|SenSura/Test 1/Test 2|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 1~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
41656|NCT01957488|O3|Outcome|SenSura|Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
41657|NCT01957488|O2|Outcome|Test 2|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
41658|NCT01957488|O1|Outcome|Test 1|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
41659|NCT01957488|E3|Reported Event|SenSura|Subjects testing SenSura
41660|NCT01957488|E2|Reported Event|Test 2|Subjects testing Coloplast Test 2
41661|NCT01957488|E1|Reported Event|Test 1|Subjects testing Coloplast Test 1
41662|NCT01957475|B1|Baseline|All Subjects|
41663|NCT01957475|P2|Participant Flow|First Coloplast Test Product Y, Then Coloplast Test Product Z|"The subjects first test test product Y and after cross-over test product Z~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
41664|NCT01957475|P1|Participant Flow|First Coloplast Test Product Z; Then Coloplast Test Product Y|"The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
41665|NCT01957475|O2|Outcome|Test Z|Results from the subjects testing Coloplast Test Y
41666|NCT01957475|O1|Outcome|Test Y|Results from the subjects testing Coloplast Test Y
41670|NCT01957462|P2|Participant Flow|First Coloplast Test X, Then Coloplast Test V|"The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
41671|NCT01957462|P1|Participant Flow|FirstColplast Test V, Then Coloplast Test X|"The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
41672|NCT01957462|O2|Outcome|Test X|the results presented for the subjects testing Test X
41673|NCT01957462|O1|Outcome|Test V|The results presented for the subjects testing Coloplast Test V
41674|NCT01957462|E2|Reported Event|Test X|the results presented for the subjects testing Test X
41675|NCT01957462|E1|Reported Event|Test V|The results presented for the subjects testing Coloplast Test V
41676|NCT01957410|B1|Baseline|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
41677|NCT01957410|P1|Participant Flow|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
41678|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
41679|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
41680|NCT01957410|E1|Reported Event|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
41681|NCT01957397|B1|Baseline|Overall Population|
41682|NCT01957397|P2|Participant Flow|1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
41683|NCT01957397|P1|Participant Flow|1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
41684|NCT01957397|O4|Outcome|Baseline - Own Product|The subjects test own product to measure their baseline leakage
41685|NCT01957397|O3|Outcome|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
41686|NCT01957397|O2|Outcome|Coloplast Test 2|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
41687|NCT01957397|O1|Outcome|Coloplast Test 1|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
41688|NCT01957397|E4|Reported Event|Baseline - Own Product|The subjects test own product to measure their baseline leakage
41689|NCT01957397|E3|Reported Event|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
41690|NCT01957397|E2|Reported Event|Coloplast Test 2|Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
41691|NCT01957397|E1|Reported Event|Coloplast Test 1|Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
41692|NCT01957384|B1|Baseline|All Subjects|
41842|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41693|NCT01957384|P6|Participant Flow|First Standard Care, Then Test Product 2, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 2~and thereafter~1) Coloplast Test product 1"
41694|NCT01957384|P5|Participant Flow|First Standard Care, Then Test Product 1, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Coloplast Test product 2"
41695|NCT01957384|P4|Participant Flow|First Test Product 2; Then Standard Care, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 1"
41696|NCT01957384|P3|Participant Flow|First Test Product 2, Then Test Product 1, Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)"
41697|NCT01957384|P2|Participant Flow|First Test Product 1, Then Standard Care, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 2"
41698|NCT01957384|P1|Participant Flow|First Test Product 1, Then Test Product 2;Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~- Coloplast Test product 2~and thereafter~- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2"
41699|NCT01957384|O3|Outcome|Standard Care|leakage data from all Standard Care baseplates
41700|NCT01957384|O2|Outcome|Coloplast Test Product 2|Leakage data from all Test 2 baseplates
41701|NCT01957384|O1|Outcome|Coloplast Test Product 1|leakage data from all Test 1 baseplates
41702|NCT01957384|E3|Reported Event|Standard Care|data from all subjects who tested Standard Care baseplates
41703|NCT01957384|E2|Reported Event|Coloplast Test Product 2|data from all subjects who tested Test 2 baseplates
41704|NCT01957384|E1|Reported Event|Coloplast Test Product 1|data from all subjects who tested Test 1 baseplates
41705|NCT01957215|B3|Baseline|Total|Total of all reporting groups
41706|NCT01957215|B2|Baseline|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41707|NCT01957215|B1|Baseline|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41708|NCT01957215|P2|Participant Flow|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
41709|NCT01957215|P1|Participant Flow|Indomethacin Patch|0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).
41710|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41711|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41712|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
41713|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41714|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41715|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41716|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
41717|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41718|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
41719|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
41720|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
41721|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
41722|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
41723|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
41724|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41725|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41726|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
41727|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID.
41728|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
41729|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
41730|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41731|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41732|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
41733|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
41734|NCT01957215|E2|Reported Event|Placebo Patch|Placebo patch to be applied on the sprained ankle BID.
41735|NCT01957215|E1|Reported Event|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle twice a day (BID).
41898|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
41899|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
41736|NCT01957202|B1|Baseline|FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
41737|NCT01957202|P18|Participant Flow|Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41738|NCT01957202|P17|Participant Flow|Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41739|NCT01957202|P16|Participant Flow|Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41740|NCT01957202|P15|Participant Flow|Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41741|NCT01957202|P14|Participant Flow|Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41742|NCT01957202|P13|Participant Flow|Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41743|NCT01957202|P12|Participant Flow|Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41744|NCT01957202|P11|Participant Flow|Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41745|NCT01957202|P10|Participant Flow|Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41746|NCT01957202|P9|Participant Flow|Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41747|NCT01957202|P8|Participant Flow|Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41843|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41748|NCT01957202|P7|Participant Flow|Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41749|NCT01957202|P6|Participant Flow|Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41750|NCT01957202|P5|Participant Flow|Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41751|NCT01957202|P4|Participant Flow|Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41752|NCT01957202|P3|Participant Flow|Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41753|NCT01957202|P2|Participant Flow|Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41754|NCT01957202|P1|Participant Flow|Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
41755|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
41756|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
41757|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
41758|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
41759|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
41760|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
41761|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
41762|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
41763|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
41764|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
41765|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
41766|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
41767|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
41768|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
41769|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
41770|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
41771|NCT01957202|E4|Reported Event|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
41772|NCT01957202|E3|Reported Event|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
41773|NCT01957202|E2|Reported Event|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
41774|NCT01957202|E1|Reported Event|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
41775|NCT01957163|B4|Baseline|Total|Total of all reporting groups
41776|NCT01957163|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41777|NCT01957163|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41778|NCT01957163|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41779|NCT01957163|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41780|NCT01957163|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41781|NCT01957163|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41782|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41783|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41784|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41785|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41786|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41787|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41788|NCT01957163|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41789|NCT01957163|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41790|NCT01957163|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
41791|NCT01957111|B3|Baseline|Total|Total of all reporting groups
41792|NCT01957111|B2|Baseline|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
41844|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
42666|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
41793|NCT01957111|B1|Baseline|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
41794|NCT01957111|P2|Participant Flow|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
41795|NCT01957111|P1|Participant Flow|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
41796|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
41797|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
41798|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
41799|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
41800|NCT01957111|E2|Reported Event|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
41801|NCT01957111|E1|Reported Event|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
41802|NCT01956240|B3|Baseline|Total|Total of all reporting groups
41803|NCT01956240|B2|Baseline|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41804|NCT01956240|B1|Baseline|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41805|NCT01956240|P2|Participant Flow|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41806|NCT01956240|P1|Participant Flow|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41895|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
42667|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
41807|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41808|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41809|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41810|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41811|NCT01956240|E2|Reported Event|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41812|NCT01956240|E1|Reported Event|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
41813|NCT01956097|B4|Baseline|Total|Total of all reporting groups
41814|NCT01956097|B3|Baseline|Placebo|"Placebo~Placebo"
41815|NCT01956097|B2|Baseline|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41816|NCT01956097|B1|Baseline|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41817|NCT01956097|P3|Participant Flow|Placebo|"Placebo~Placebo"
41818|NCT01956097|P2|Participant Flow|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41819|NCT01956097|P1|Participant Flow|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41820|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
41821|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41822|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41823|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
41824|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41825|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41826|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
41827|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41828|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41829|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
41830|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41831|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41832|NCT01956097|E3|Reported Event|Placebo|"Placebo~Placebo"
41833|NCT01956097|E2|Reported Event|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
41834|NCT01956097|E1|Reported Event|HX106 590mg|"HX106 590mg/day~HX106 590mg"
41835|NCT01956032|B1|Baseline|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41836|NCT01956032|P1|Participant Flow|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41837|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41838|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41839|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41840|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41841|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41896|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
41845|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41846|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41847|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41848|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41849|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41850|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41851|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41852|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41853|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41854|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41855|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41856|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41857|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41858|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41859|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41860|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41861|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41862|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41863|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41864|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41865|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41866|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41897|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
94266|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
41867|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41868|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41869|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41870|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41871|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41872|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41873|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41874|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41875|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41876|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41877|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41878|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41879|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41880|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41881|NCT01956032|E1|Reported Event|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
41882|NCT01955720|B1|Baseline|Total Subjects Group|The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
41883|NCT01955720|P6|Participant Flow|Placebo / 1 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
41884|NCT01955720|P5|Participant Flow|1 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose)
41885|NCT01955720|P4|Participant Flow|Placebo / 2.5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose)
41886|NCT01955720|P3|Participant Flow|2.5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose)
41887|NCT01955720|P2|Participant Flow|Placebo / 5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose)
41888|NCT01955720|P1|Participant Flow|5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose)
41889|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
41890|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
41891|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
41892|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41893|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
41894|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
94267|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
41900|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41901|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
41902|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41903|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
41904|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
41905|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
41906|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
41907|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
41908|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
41909|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
41910|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
41911|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
41912|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41913|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
41914|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
41915|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
41916|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41917|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
41918|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
41919|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
41920|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
41921|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
41922|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
41923|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
41924|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
41925|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
41926|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
41927|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41928|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
41929|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
41930|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
41931|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
41932|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
41933|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
41934|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
41935|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
41936|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
41937|NCT01955720|O6|Outcome|150 mg/1 g Mild Renal Impairment (RI)|Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
41938|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41939|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
41940|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
41941|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
41942|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
41943|NCT01955720|O1|Outcome|On Treatment Group|during the treatment period.
41944|NCT01955720|O2|Outcome|Idarucizumab (Ida)|Idarucizumab (Ida).
41945|NCT01955720|O1|Outcome|Placebo|idarucizumab-matching placebo
41946|NCT01955720|E7|Reported Event|High (5g) Placebo Dose|Subjects with high (5g) placebo dose treatment
41947|NCT01955720|E6|Reported Event|Medium (2.5g) Placebo Dose|Subjects with medium (2.5g) placebo dose treatment
41948|NCT01955720|E5|Reported Event|Low (1g) Placebo Dose|Subjects with low (1g) placebo dose treatment
41949|NCT01955720|E4|Reported Event|High (5g) Idarucizumab Dose|Subjects with high (5g) idarucizumab dose treatment
41950|NCT01955720|E3|Reported Event|Medium (2.5g) Idarucizumab Dose|Subjects with medium (2.5g) idarucizumab dose treatment
41951|NCT01955720|E2|Reported Event|Low (1g) Idarucizumab Dose|Subjects with low 1g idarucizumab dose treatment
41952|NCT01955720|E1|Reported Event|Dabigatran Etexilate (DE)|subjects with Dabigatran etexilate (DE) treatment
41953|NCT01955707|B3|Baseline|Total|Total of all reporting groups
41954|NCT01955707|B2|Baseline|Natalizumab|300 mg single IV injection of natalizumab
41955|NCT01955707|B1|Baseline|Placebo|A single IV injection of placebo
41956|NCT01955707|P2|Participant Flow|Natalizumab|300 mg single IV injection of natalizumab
41957|NCT01955707|P1|Participant Flow|Placebo|A single intravenous (IV) injection of placebo
41958|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41959|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41960|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41961|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41962|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41963|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41964|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41965|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41966|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41967|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41968|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41969|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41970|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41971|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41972|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41973|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41974|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41975|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41976|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
41977|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
41978|NCT01955707|E2|Reported Event|Natalizumab|300 mg single IV injection of natalizumab
41979|NCT01955707|E1|Reported Event|Placebo|A single IV injection of placebo
41980|NCT01955629|B1|Baseline|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41981|NCT01955629|P1|Participant Flow|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
41982|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41983|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41984|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41985|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41986|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41987|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41988|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41989|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
42035|NCT01955044|P3|Participant Flow|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
41990|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
41991|NCT01955629|E1|Reported Event|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
41992|NCT01955369|B1|Baseline|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41993|NCT01955369|P1|Participant Flow|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41994|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41995|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41996|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41997|NCT01955369|E1|Reported Event|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
41998|NCT01955083|B3|Baseline|Total|Total of all reporting groups
41999|NCT01955083|B2|Baseline|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
42000|NCT01955083|B1|Baseline|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
42001|NCT01955083|P2|Participant Flow|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant."
42002|NCT01955083|P1|Participant Flow|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance)."
42003|NCT01955083|O2|Outcome|Percentage of Good Response at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percentage of good response at 3 months after surgery was calculated."
42004|NCT01955083|O1|Outcome|Percentage of Good Response at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percentage of good response was calculated."
42005|NCT01955083|O2|Outcome|Percent Change in B1-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
42006|NCT01955083|O1|Outcome|Percent Change in B1-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
42007|NCT01955083|O2|Outcome|Percent Change in B1-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
42008|NCT01955083|O1|Outcome|Percent Change in B1-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
42009|NCT01955083|O2|Outcome|Percent Change in B1-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
42036|NCT01955044|P2|Participant Flow|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
94268|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
42010|NCT01955083|O1|Outcome|Percent Change in B1-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
42011|NCT01955083|O2|Outcome|Percent Change in B1-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
42012|NCT01955083|O1|Outcome|Percent Change in B1-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
42013|NCT01955083|O2|Outcome|Percent Change in B1-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
42014|NCT01955083|O1|Outcome|Percent Change in B1-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
42015|NCT01955083|O2|Outcome|Percent Change in Total-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
42016|NCT01955083|O1|Outcome|Percent Change in Total-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
42017|NCT01955083|O2|Outcome|Percent Change in Total-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
42018|NCT01955083|O1|Outcome|Percent Change in Total-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
42019|NCT01955083|O2|Outcome|Percent Change in Total-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
42020|NCT01955083|O1|Outcome|Percent Change in Total-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
42021|NCT01955083|O2|Outcome|Percent Change in Total-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
42022|NCT01955083|O1|Outcome|Percent Change in Total-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
42023|NCT01955083|O2|Outcome|Percent Change in Total-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
42024|NCT01955083|O1|Outcome|Percent Change in Total-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
42025|NCT01955083|O2|Outcome|Change in SOS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
42026|NCT01955083|O1|Outcome|Change in SOS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
42027|NCT01955083|O2|Outcome|Change in VAS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
42028|NCT01955083|O1|Outcome|Change in VAS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
42029|NCT01955083|E2|Reported Event|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
42030|NCT01955083|E1|Reported Event|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
42031|NCT01955044|B4|Baseline|Total|Total of all reporting groups
42032|NCT01955044|B3|Baseline|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
42033|NCT01955044|B2|Baseline|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42034|NCT01955044|B1|Baseline|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42037|NCT01955044|P1|Participant Flow|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42038|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
42039|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42040|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42041|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
42042|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42043|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42044|NCT01955044|E3|Reported Event|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
42045|NCT01955044|E2|Reported Event|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42046|NCT01955044|E1|Reported Event|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
42047|NCT01955005|B3|Baseline|Total|Total of all reporting groups
42048|NCT01955005|B2|Baseline|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42049|NCT01955005|B1|Baseline|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42050|NCT01955005|P2|Participant Flow|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42051|NCT01955005|P1|Participant Flow|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42052|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42053|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42054|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42055|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42056|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42057|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42058|NCT01955005|E2|Reported Event|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
42059|NCT01955005|E1|Reported Event|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
42074|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42075|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42060|NCT01954745|B1|Baseline|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42061|NCT01954745|P1|Participant Flow|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42062|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42063|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42064|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42065|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42066|NCT01954745|E1|Reported Event|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
42067|NCT01954251|B3|Baseline|Total|Total of all reporting groups
42068|NCT01954251|B2|Baseline|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42069|NCT01954251|B1|Baseline|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42070|NCT01954251|P2|Participant Flow|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42071|NCT01954251|P1|Participant Flow|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42072|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42073|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42600|NCT01952366|O1|Outcome|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
42076|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42077|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42078|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42079|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42080|NCT01954251|O1|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42081|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42082|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42083|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42084|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42085|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42086|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42087|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42088|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42089|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42090|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42091|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42092|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42093|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42094|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42095|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42096|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42097|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42098|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42099|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42100|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42101|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42102|NCT01954251|E2|Reported Event|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
42103|NCT01954251|E1|Reported Event|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
42104|NCT01954160|B3|Baseline|Total|Total of all reporting groups
42105|NCT01954160|B2|Baseline|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42106|NCT01954160|B1|Baseline|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42107|NCT01954160|P2|Participant Flow|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42108|NCT01954160|P1|Participant Flow|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42109|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42110|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42111|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42112|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42113|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42114|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42115|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42116|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42117|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42118|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42119|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42120|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42121|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42122|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42123|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42124|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42125|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42126|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42127|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42128|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42129|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42130|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42161|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42131|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42132|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42133|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42134|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42135|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42136|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42137|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42138|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42139|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42140|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42141|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42142|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42143|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42144|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42145|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42146|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42147|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42148|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42149|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42150|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42151|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42152|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42153|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42154|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42155|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42156|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42157|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42158|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42159|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
42160|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
42162|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42163|NCT01954160|E2|Reported Event|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
42164|NCT01954160|E1|Reported Event|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
42165|NCT01954121|B3|Baseline|Total Title|
42166|NCT01954121|B2|Baseline|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42167|NCT01954121|B1|Baseline|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42168|NCT01954121|P2|Participant Flow|Carbamazepine-IR|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42169|NCT01954121|P1|Participant Flow|Levetiracetam|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42170|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42171|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42172|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42173|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42174|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42175|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42176|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42177|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42178|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42179|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42180|NCT01954121|E2|Reported Event|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
42181|NCT01954121|E1|Reported Event|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
42182|NCT01953354|B3|Baseline|Total|Total of all reporting groups
42183|NCT01953354|B2|Baseline|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42184|NCT01953354|B1|Baseline|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42185|NCT01953354|P2|Participant Flow|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42186|NCT01953354|P1|Participant Flow|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42187|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42188|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42189|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42190|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42191|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42192|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42193|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42194|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42195|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42196|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42197|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42198|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42199|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42200|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42201|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42202|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42203|NCT01953354|E2|Reported Event|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
42204|NCT01953354|E1|Reported Event|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
42205|NCT01953328|B9|Baseline|Total|Total of all reporting groups
42206|NCT01953328|B8|Baseline|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42207|NCT01953328|B7|Baseline|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42208|NCT01953328|B6|Baseline|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42209|NCT01953328|B5|Baseline|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42210|NCT01953328|B4|Baseline|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42211|NCT01953328|B3|Baseline|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42212|NCT01953328|B2|Baseline|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42213|NCT01953328|B1|Baseline|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42214|NCT01953328|P8|Participant Flow|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42215|NCT01953328|P7|Participant Flow|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42216|NCT01953328|P6|Participant Flow|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42217|NCT01953328|P5|Participant Flow|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42218|NCT01953328|P4|Participant Flow|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42219|NCT01953328|P3|Participant Flow|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42220|NCT01953328|P2|Participant Flow|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42221|NCT01953328|P1|Participant Flow|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42222|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42223|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42224|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42225|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42226|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42227|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42228|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42229|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42230|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42231|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42232|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42233|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42234|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42235|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42236|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42237|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42238|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42239|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42240|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42241|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42242|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42243|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42244|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42245|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42246|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42247|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42248|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42249|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42250|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42251|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42252|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42253|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42254|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42655|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42656|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42255|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42256|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42257|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42258|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42259|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42260|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42261|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42262|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42263|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42264|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42265|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42266|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42267|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42268|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42269|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42270|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42271|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42272|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42273|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42274|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42275|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42276|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42277|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42278|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42279|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42280|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42281|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42282|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42283|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42284|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42285|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42286|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42287|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42288|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42289|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42290|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42291|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42292|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42293|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42294|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42295|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42296|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42297|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42298|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42299|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42300|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42301|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42302|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42303|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42304|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42305|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42306|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42307|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42308|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42309|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42310|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42311|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42312|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42313|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42314|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42315|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42316|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42317|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42318|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42319|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42320|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42321|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42322|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42323|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42324|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42325|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42326|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42327|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42328|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42329|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42330|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42331|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42332|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42333|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42334|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42335|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42336|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42337|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42338|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42339|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42340|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42341|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42342|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42343|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42344|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42345|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42346|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42347|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42348|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42349|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42350|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42351|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42352|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42353|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42354|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42355|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42356|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42357|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42358|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42359|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42360|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42361|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42362|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42363|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42364|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42365|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42366|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42367|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42368|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42369|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42370|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42371|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42372|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42373|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42374|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42375|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42376|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42377|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42378|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42379|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42380|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42381|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42382|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42383|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42384|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42385|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42386|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42387|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42388|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42389|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42390|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42391|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42392|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42393|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42394|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42395|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42396|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42397|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42398|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42399|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42400|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42401|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42402|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42403|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42404|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42405|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42406|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42407|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42408|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42409|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42410|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42411|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42412|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42413|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42414|NCT01953328|E8|Reported Event|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42415|NCT01953328|E7|Reported Event|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42416|NCT01953328|E6|Reported Event|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
42417|NCT01953328|E5|Reported Event|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
42418|NCT01953328|E4|Reported Event|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
42419|NCT01953328|E3|Reported Event|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
42420|NCT01953328|E2|Reported Event|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
42421|NCT01953328|E1|Reported Event|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
42422|NCT01953237|B3|Baseline|Total|Total of all reporting groups
42423|NCT01953237|B2|Baseline|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
42424|NCT01953237|B1|Baseline|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
42425|NCT01953237|P2|Participant Flow|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
42426|NCT01953237|P1|Participant Flow|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
42427|NCT01953237|O2|Outcome|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
42443|NCT01952691|E1|Reported Event|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
42428|NCT01953237|O1|Outcome|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
42429|NCT01953237|E2|Reported Event|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
42430|NCT01953237|E1|Reported Event|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
42431|NCT01952834|B1|Baseline|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42432|NCT01952834|P1|Participant Flow|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42433|NCT01952834|O1|Outcome|Probiotic Supplementation|The measurement of IL-2 represents the change in IL-12 +/- standard deviation of the change following 6 weeks of probiotic supplementation.
42434|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42435|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42436|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42437|NCT01952834|E1|Reported Event|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
42438|NCT01952691|B1|Baseline|Kinesiotaping|"all patients were implemented a kinesiotaping to align the hallux to correct position~kinesiotaping: correction method was used to align hallux."
42439|NCT01952691|P1|Participant Flow|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
42440|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
42441|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
42442|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
42444|NCT01952665|B3|Baseline|Total|Total of all reporting groups
42657|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42445|NCT01952665|B2|Baseline|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42446|NCT01952665|B1|Baseline|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42447|NCT01952665|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42448|NCT01952665|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42449|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
42450|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42451|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42452|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
42453|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42454|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42455|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42456|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42457|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42458|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42459|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42460|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42461|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42462|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42463|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42464|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42465|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42466|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42467|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42468|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42469|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42470|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42471|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42472|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42473|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42474|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
94269|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
42475|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42476|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42477|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42478|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42479|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42480|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42481|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42482|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42483|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42484|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42485|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42486|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42487|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42488|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42489|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42490|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42491|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42492|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42493|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42494|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42495|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42496|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42497|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42498|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42499|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42500|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42501|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42502|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42503|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42504|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42505|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42506|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42507|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42508|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42509|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42510|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42511|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
42512|NCT01952665|O1|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42513|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42514|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42515|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42516|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42517|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42518|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42519|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42520|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42521|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42522|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42523|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42524|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42525|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42526|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42527|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42528|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42529|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
42530|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42531|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42532|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42533|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42534|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42599|NCT01952366|P1|Participant Flow|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
42535|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42536|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42537|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42538|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42539|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42540|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42541|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42542|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42543|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42544|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42545|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42546|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42547|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42548|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42549|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42550|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42551|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42552|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42553|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42554|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42555|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42556|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42557|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42558|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42559|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42560|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42561|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42562|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42563|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42564|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42565|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42566|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42567|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42568|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42569|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42570|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42571|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42572|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42573|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42574|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42575|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42576|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42577|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42578|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42579|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42580|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42581|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42582|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
42583|NCT01952665|E2|Reported Event|Lotrafilcon B|"Daily wear soft contact lens lotrafilcon B~comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
42584|NCT01952665|E1|Reported Event|Comfilcon A|"Daily wear soft contact lens comfilcon A~lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
42585|NCT01952600|B4|Baseline|Total|Total of all reporting groups
42586|NCT01952600|B3|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
42587|NCT01952600|B2|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
42588|NCT01952600|B1|Baseline|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
42589|NCT01952600|P3|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
42590|NCT01952600|P2|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
42591|NCT01952600|P1|Participant Flow|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
42592|NCT01952600|O3|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
42593|NCT01952600|O2|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
42594|NCT01952600|O1|Outcome|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
42595|NCT01952600|E3|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
42596|NCT01952600|E2|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
42597|NCT01952600|E1|Reported Event|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
42598|NCT01952366|B1|Baseline|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
94270|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
42601|NCT01952366|O2|Outcome|Remission in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
42602|NCT01952366|O1|Outcome|Response in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.
42603|NCT01952366|E1|Reported Event|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
42604|NCT01952301|B1|Baseline|Xenogeneic Collagen Matrix Versus Free Gingival Graft|free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
42605|NCT01952301|P1|Participant Flow|XCM Versus FGG|xenogeneic collagen matrix versus free gingival graft
42606|NCT01952301|O2|Outcome|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
42607|NCT01952301|O1|Outcome|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
42608|NCT01952301|E2|Reported Event|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
42609|NCT01952301|E1|Reported Event|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
42610|NCT01952145|B3|Baseline|Total|Total of all reporting groups
42611|NCT01952145|B2|Baseline|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42612|NCT01952145|B1|Baseline|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42613|NCT01952145|P2|Participant Flow|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42614|NCT01952145|P1|Participant Flow|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42615|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42616|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42617|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42658|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42659|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42660|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42661|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42662|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42663|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42664|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42618|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42619|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42620|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42621|NCT01952145|E2|Reported Event|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42622|NCT01952145|E1|Reported Event|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
42623|NCT01952080|B5|Baseline|Total|Total of all reporting groups
42624|NCT01952080|B4|Baseline|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42625|NCT01952080|B3|Baseline|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42626|NCT01952080|B2|Baseline|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42627|NCT01952080|B1|Baseline|Standard of Care|SOC- no teduglutide therapy
42628|NCT01952080|P4|Participant Flow|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42629|NCT01952080|P3|Participant Flow|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42630|NCT01952080|P2|Participant Flow|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42631|NCT01952080|P1|Participant Flow|Standard of Care|SOC- no teduglutide therapy
42632|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42633|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42634|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42635|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42636|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42637|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42638|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42639|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42640|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42641|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42642|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42643|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42644|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42645|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42646|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42647|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42648|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42649|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42650|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42651|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42652|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42653|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42654|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42668|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42669|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42670|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42671|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
42672|NCT01952080|E4|Reported Event|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
42673|NCT01952080|E3|Reported Event|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
42674|NCT01952080|E2|Reported Event|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
42675|NCT01952080|E1|Reported Event|Standard of Care|SOC- no teduglutide therapy
42676|NCT01951950|B3|Baseline|Total|Total of all reporting groups
42677|NCT01951950|B2|Baseline|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42678|NCT01951950|B1|Baseline|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42679|NCT01951950|P2|Participant Flow|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42680|NCT01951950|P1|Participant Flow|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42681|NCT01951950|O2|Outcome|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42682|NCT01951950|O1|Outcome|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42683|NCT01951950|E2|Reported Event|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42684|NCT01951950|E1|Reported Event|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
42685|NCT01951820|B3|Baseline|Total|Total of all reporting groups
42686|NCT01951820|B2|Baseline|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42687|NCT01951820|B1|Baseline|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42688|NCT01951820|P2|Participant Flow|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42689|NCT01951820|P1|Participant Flow|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
94271|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
42690|NCT01951820|O2|Outcome|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42691|NCT01951820|O1|Outcome|Benzocaine|"Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42692|NCT01951820|E2|Reported Event|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42693|NCT01951820|E1|Reported Event|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
42694|NCT01951703|B3|Baseline|Total|Total of all reporting groups
42695|NCT01951703|B2|Baseline|Test/Control|Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
42696|NCT01951703|B1|Baseline|Control/Test|Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.
42697|NCT01951703|P2|Participant Flow|Test/Control|Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
42698|NCT01951703|P1|Participant Flow|Control/Test|Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.
42699|NCT01951703|O2|Outcome|Test, Senofilcon A|Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
42700|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
42701|NCT01951703|O2|Outcome|Test, Senofilcon A|Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
42702|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
42703|NCT01951703|E2|Reported Event|Test, Senofilcon A|Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,
42704|NCT01951703|E1|Reported Event|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
42705|NCT01951651|B3|Baseline|Total|Total of all reporting groups
42706|NCT01951651|B2|Baseline|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42707|NCT01951651|B1|Baseline|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42708|NCT01951651|P2|Participant Flow|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42709|NCT01951651|P1|Participant Flow|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
94272|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
42710|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42711|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42712|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42713|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42714|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42715|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42716|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42717|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42743|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42718|NCT01951651|E2|Reported Event|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42719|NCT01951651|E1|Reported Event|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
42720|NCT01951573|B1|Baseline|Overall|Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
42721|NCT01951573|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
42722|NCT01951573|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
42723|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42724|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42725|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42726|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42727|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42728|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42729|NCT01951573|E2|Reported Event|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42730|NCT01951573|E1|Reported Event|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
42731|NCT01951417|B1|Baseline|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42732|NCT01951417|P1|Participant Flow|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42733|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42734|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42735|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42736|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42737|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42738|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42739|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42740|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42741|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42742|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
43159|NCT01949142|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
42744|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42745|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42746|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42747|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42748|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42749|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42750|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42751|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42752|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42753|NCT01951417|E1|Reported Event|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
42754|NCT01951170|B1|Baseline|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42755|NCT01951170|P1|Participant Flow|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks"
42756|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42757|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42758|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42759|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42760|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42761|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42762|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42763|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42764|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42765|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42766|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42767|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42768|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42769|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42770|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42771|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42772|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42773|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42774|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42775|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
42776|NCT01951170|E1|Reported Event|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks"
42777|NCT01951092|B1|Baseline|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
42778|NCT01951092|P1|Participant Flow|Single Arm Intervention Study|"All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.~Text messaging"
42779|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
42780|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
42781|NCT01951092|E1|Reported Event|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
42782|NCT01951066|B1|Baseline|All Participants|
42783|NCT01951066|P2|Participant Flow|Group 2 (Anti-VEGF/Dexamethasone Implant)|"Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
42784|NCT01951066|P1|Participant Flow|Group 1 (Dexamethasone Implant/Anti-VEGF)|"Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
42785|NCT01951066|O2|Outcome|Anti-VEGF Agent|Patients received PRN injections of an Anti-VEGF agent
42786|NCT01951066|O1|Outcome|Dexamethasone Implant|Patients received an injection of an dexamethasone implant
42787|NCT01951066|E1|Reported Event|All Participants|
42788|NCT01950741|B1|Baseline|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42789|NCT01950741|P1|Participant Flow|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42790|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42791|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42792|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42793|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
43160|NCT01949142|O2|Outcome|Sham|Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.
42794|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42795|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
42796|NCT01950741|E1|Reported Event|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.~Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients."
42797|NCT01950364|B3|Baseline|Total|Total of all reporting groups
42798|NCT01950364|B2|Baseline|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42799|NCT01950364|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42800|NCT01950364|P2|Participant Flow|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42801|NCT01950364|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42802|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42803|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42804|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42805|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42806|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42807|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42808|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42809|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42810|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42811|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42812|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42813|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42814|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42815|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42816|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42817|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42818|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
43279|NCT01948076|B1|Baseline|Resident Without GE Vscan|baseline physical exam use
42819|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42820|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42821|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42822|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42823|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42824|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42825|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42826|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42827|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42828|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42829|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42830|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42831|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42832|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42833|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42834|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42835|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42836|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42837|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42838|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42839|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42840|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42841|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42842|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42843|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42844|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
43548|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
42845|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42846|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42847|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42848|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42849|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42850|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42851|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42852|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42853|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42854|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42855|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42856|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42857|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42858|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42859|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42860|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42861|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42862|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42863|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42864|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42865|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42866|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42867|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42868|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42869|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42870|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
43549|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
42871|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42872|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42873|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42874|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42875|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42876|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42877|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42878|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42879|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42880|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42881|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42882|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42883|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42884|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42885|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42886|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42887|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42888|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42889|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42890|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42891|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42892|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42893|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42894|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
42895|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42896|NCT01950364|E2|Reported Event|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
43550|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
42897|NCT01950364|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
42898|NCT01950078|B3|Baseline|Total|Total of all reporting groups
42899|NCT01950078|B2|Baseline|Healthy Volunteers Group|grouped by healthy college students
42900|NCT01950078|B1|Baseline|Surgical Patients|grouped by receiving surgery
42901|NCT01950078|P2|Participant Flow|Healthy Volunteers Group|grouped by healthy college students
42902|NCT01950078|P1|Participant Flow|Surgical Patients|grouped by receiving surgery
42903|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
42904|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
42905|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
42906|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
42907|NCT01950078|E2|Reported Event|Healthy Volunteers Group|grouped by healthy college students
42908|NCT01950078|E1|Reported Event|Surgical Patients|grouped by receiving surgery
42909|NCT01949870|B1|Baseline|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
42910|NCT01949870|P1|Participant Flow|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
42911|NCT01949870|O1|Outcome|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
42912|NCT01949870|E1|Reported Event|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
42913|NCT01949545|B5|Baseline|Total|Total of all reporting groups
42914|NCT01949545|B4|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42915|NCT01949545|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42916|NCT01949545|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42917|NCT01949545|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42918|NCT01949545|P4|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42919|NCT01949545|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42920|NCT01949545|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42921|NCT01949545|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43067|NCT01949532|B2|Baseline|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
42922|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42923|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42924|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42925|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42926|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42927|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42928|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42929|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42930|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42931|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42932|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42933|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43147|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
43551|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
42934|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42935|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42936|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42937|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42938|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42939|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42940|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42941|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42942|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42943|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42944|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42945|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43148|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
42946|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42947|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42948|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42949|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42950|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42951|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42952|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42953|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42954|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42955|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42956|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42957|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43149|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
43552|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
42958|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42959|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42960|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42961|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42962|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42963|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42964|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42965|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42966|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42967|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42968|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42969|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43150|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
42970|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42971|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42972|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42973|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42974|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42975|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42976|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42977|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42978|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42979|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42980|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42981|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43151|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43586|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
42982|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42983|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42984|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42985|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42986|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42987|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42988|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42989|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42990|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42991|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42992|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42993|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43152|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
42994|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42995|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42996|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42997|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42998|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
42999|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43000|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43001|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43002|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43003|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43004|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43005|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43153|NCT01949155|E2|Reported Event|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
94273|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
43006|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43007|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43008|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43009|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43010|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43011|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43012|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43013|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43014|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43015|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43016|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43017|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43154|NCT01949155|E1|Reported Event|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43018|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43019|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43020|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43021|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43022|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43023|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43024|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43025|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43026|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43027|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43028|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43029|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43155|NCT01949142|B3|Baseline|Total|Total of all reporting groups
43156|NCT01949142|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43030|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43031|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43032|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43033|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43034|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43035|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43036|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43037|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43038|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43039|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43040|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43041|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43157|NCT01949142|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43042|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43043|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43044|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43045|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43046|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43047|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43048|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43049|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43050|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43051|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43052|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43053|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43158|NCT01949142|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
94274|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
43054|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43055|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43056|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43057|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43058|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43059|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43060|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43061|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43062|NCT01949545|E4|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43063|NCT01949545|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43064|NCT01949545|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43065|NCT01949545|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
43066|NCT01949532|B3|Baseline|Total|Total of all reporting groups
43222|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43068|NCT01949532|B1|Baseline|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43069|NCT01949532|P2|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
43070|NCT01949532|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance [CrCl] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
43071|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43072|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43073|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43074|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43075|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43076|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43077|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43078|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43079|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43080|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43081|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43082|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43083|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43084|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43085|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43086|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43087|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43088|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43089|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43090|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43091|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43092|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43093|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43094|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43095|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43096|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43097|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43098|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43099|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43100|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43101|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43102|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43103|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43104|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43105|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43106|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43107|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43108|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43109|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43110|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43111|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43112|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43113|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43114|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43115|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43116|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43117|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43118|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43119|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43120|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43121|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43122|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43123|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43124|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43125|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43126|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43127|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43128|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43129|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43130|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43131|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43132|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43133|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43134|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43135|NCT01949532|E2|Reported Event|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43136|NCT01949532|E1|Reported Event|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
43137|NCT01949389|B1|Baseline|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
43138|NCT01949389|P1|Participant Flow|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
43139|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
43140|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
43141|NCT01949389|E1|Reported Event|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
43142|NCT01949155|B3|Baseline|Total|Total of all reporting groups
43143|NCT01949155|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43144|NCT01949155|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43145|NCT01949155|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43146|NCT01949155|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43161|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43162|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43163|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43164|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
43165|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
43166|NCT01949142|E2|Reported Event|Sham-Simulated Single, Intratympanic Injection|Sham: One sham injection into each ear during surgery.
43167|NCT01949142|E1|Reported Event|OTO-201 Single, Intratympanic Injection|OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
43168|NCT01949051|B1|Baseline|Placebo/Levocabastine|Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
43169|NCT01949051|P6|Participant Flow|Sequence 6: Placebo, Levo 400µg and Levo 200µg|Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43170|NCT01949051|P5|Participant Flow|Sequence 5: Levo 400µg, Levo 200µg and Placebo|Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43171|NCT01949051|P4|Participant Flow|Sequence 4: Levo 200µg, Placebo, and Levo 400µg|Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43172|NCT01949051|P3|Participant Flow|Sequence 3: Placebo, Levo 200µg and Levo 400µg|Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43173|NCT01949051|P2|Participant Flow|Sequence 2: Levo 400µg, Placebo and Levo 200µg|Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43174|NCT01949051|P1|Participant Flow|Sequence 1: Levo 200 µg, Levo 400µg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
43175|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43176|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43177|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43178|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43179|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43180|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43181|NCT01949051|E3|Reported Event|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
44169|NCT01941498|O2|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
43182|NCT01949051|E2|Reported Event|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43183|NCT01949051|E1|Reported Event|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
43184|NCT01948908|B4|Baseline|Total|Total of all reporting groups
43185|NCT01948908|B3|Baseline|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43186|NCT01948908|B2|Baseline|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43187|NCT01948908|B1|Baseline|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43188|NCT01948908|P3|Participant Flow|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43189|NCT01948908|P2|Participant Flow|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43190|NCT01948908|P1|Participant Flow|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43191|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43192|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43193|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43194|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43195|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43196|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43197|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43198|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43199|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43200|NCT01948908|E3|Reported Event|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43201|NCT01948908|E2|Reported Event|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43202|NCT01948908|E1|Reported Event|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
43203|NCT01948830|B3|Baseline|Total|Total of all reporting groups
43204|NCT01948830|B2|Baseline|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43205|NCT01948830|B1|Baseline|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43206|NCT01948830|P2|Participant Flow|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43207|NCT01948830|P1|Participant Flow|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43208|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43209|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43210|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43211|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43212|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43213|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43214|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43215|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43216|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43217|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43218|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43219|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43220|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43221|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
44170|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
43223|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43224|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43225|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43226|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43227|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43228|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43229|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43230|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43231|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43232|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43233|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43234|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43235|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43236|NCT01948830|E2|Reported Event|Group II Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
43237|NCT01948830|E1|Reported Event|Group I Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
43238|NCT01948791|B1|Baseline|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43239|NCT01948791|P1|Participant Flow|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43240|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43241|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43242|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43243|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43244|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43245|NCT01948791|E1|Reported Event|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
43246|NCT01948518|B1|Baseline|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
43247|NCT01948518|P1|Participant Flow|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
43248|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
43249|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
43250|NCT01948518|E1|Reported Event|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
43251|NCT01948375|B3|Baseline|Total|Total of all reporting groups
43252|NCT01948375|B2|Baseline|Real Needle - Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43253|NCT01948375|B1|Baseline|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43274|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43275|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43373|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43254|NCT01948375|P2|Participant Flow|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
43255|NCT01948375|P1|Participant Flow|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
43256|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43257|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43258|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43259|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43260|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~real needle- placebo needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43261|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~placebo needle - real needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43276|NCT01948193|E1|Reported Event|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43262|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43263|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43264|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43265|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
43266|NCT01948375|E2|Reported Event|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
43267|NCT01948375|E1|Reported Event|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
43268|NCT01948193|B1|Baseline|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43269|NCT01948193|P1|Participant Flow|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43270|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43271|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43272|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43273|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
43277|NCT01948076|B3|Baseline|Total|Total of all reporting groups
43278|NCT01948076|B2|Baseline|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
43280|NCT01948076|P2|Participant Flow|Intervention Group|Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam
43281|NCT01948076|P1|Participant Flow|Control Group|Performed only physical exam with no access to ultrasoun
43282|NCT01948076|O2|Outcome|Intervention Group (Using Ultrasound)|residents with augmentation of physical exam by ultrasound
43283|NCT01948076|O1|Outcome|Intervention Group (Using Physical Exam Only)|Baseline physical exam prior to using the ultrasound
43284|NCT01948076|O2|Outcome|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
43285|NCT01948076|O1|Outcome|Resident Without GE Vscan|baseline physical exam use
43286|NCT01948076|E2|Reported Event|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
43287|NCT01948076|E1|Reported Event|Resident Without GE Vscan|baseline physical exam use
43288|NCT01948050|B3|Baseline|Total|Total of all reporting groups
43289|NCT01948050|B2|Baseline|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
43290|NCT01948050|B1|Baseline|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
43291|NCT01948050|P2|Participant Flow|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
43292|NCT01948050|P1|Participant Flow|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
43293|NCT01948050|O2|Outcome|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
43294|NCT01948050|O1|Outcome|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
43295|NCT01948050|E2|Reported Event|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
43296|NCT01948050|E1|Reported Event|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
43297|NCT01947946|B4|Baseline|Total|Total of all reporting groups
43298|NCT01947946|B3|Baseline|Placebo|A (Dummy) injection
43299|NCT01947946|B2|Baseline|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
43300|NCT01947946|B1|Baseline|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
43301|NCT01947946|P3|Participant Flow|Placebo|A (Dummy) injection
43302|NCT01947946|P2|Participant Flow|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
43303|NCT01947946|P1|Participant Flow|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
43304|NCT01947946|O3|Outcome|Placebo|A (Dummy) injection
43305|NCT01947946|O2|Outcome|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
43306|NCT01947946|O1|Outcome|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
43307|NCT01947946|E3|Reported Event|Placebo|A (Dummy) injection
43308|NCT01947946|E2|Reported Event|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
43309|NCT01947946|E1|Reported Event|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
43310|NCT01947907|B5|Baseline|Total|Total of all reporting groups
43311|NCT01947907|B4|Baseline|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43312|NCT01947907|B3|Baseline|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43313|NCT01947907|B2|Baseline|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43314|NCT01947907|B1|Baseline|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43315|NCT01947907|P4|Participant Flow|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43316|NCT01947907|P3|Participant Flow|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43317|NCT01947907|P2|Participant Flow|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43318|NCT01947907|P1|Participant Flow|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43319|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43320|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43321|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43322|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43323|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43324|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43325|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43326|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43327|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43328|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43329|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43330|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43331|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43332|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43333|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43334|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43335|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43336|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43337|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43338|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43339|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43340|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43341|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43342|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43343|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43344|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43345|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43346|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43347|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43348|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43349|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43350|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43351|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43352|NCT01947907|E4|Reported Event|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
43353|NCT01947907|E3|Reported Event|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43354|NCT01947907|E2|Reported Event|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43355|NCT01947907|E1|Reported Event|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
43356|NCT01947855|B4|Baseline|Total|Total of all reporting groups
43357|NCT01947855|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
43358|NCT01947855|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
43359|NCT01947855|B1|Baseline|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
43360|NCT01947855|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
43361|NCT01947855|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
43362|NCT01947855|P1|Participant Flow|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
43363|NCT01947855|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
43364|NCT01947855|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
43365|NCT01947855|O1|Outcome|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
43366|NCT01947855|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
43367|NCT01947855|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
43368|NCT01947855|E1|Reported Event|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
43369|NCT01947582|B1|Baseline|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43370|NCT01947582|P1|Participant Flow|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43371|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43372|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43374|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43375|NCT01947582|E1|Reported Event|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
43376|NCT01947491|B5|Baseline|Total|Total of all reporting groups
43377|NCT01947491|B4|Baseline|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
43378|NCT01947491|B3|Baseline|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
43379|NCT01947491|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
43380|NCT01947491|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
43381|NCT01947491|P4|Participant Flow|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
43382|NCT01947491|P3|Participant Flow|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
43383|NCT01947491|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
43384|NCT01947491|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
43385|NCT01947491|O4|Outcome|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
43386|NCT01947491|O3|Outcome|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
43387|NCT01947491|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
43388|NCT01947491|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
43389|NCT01947491|E4|Reported Event|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
43390|NCT01947491|E3|Reported Event|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
43391|NCT01947491|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
43392|NCT01947491|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
43393|NCT01947335|B3|Baseline|Total|Total of all reporting groups
43394|NCT01947335|B2|Baseline|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43395|NCT01947335|B1|Baseline|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43396|NCT01947335|P2|Participant Flow|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43397|NCT01947335|P1|Participant Flow|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43398|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43399|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43400|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43401|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43402|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43403|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43404|NCT01947335|E2|Reported Event|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
43405|NCT01947335|E1|Reported Event|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
43406|NCT01947153|B1|Baseline|All Subjects|All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination.
43407|NCT01947153|P2|Participant Flow|Free Combination First, Then Fixed Dose Combination|Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets
43408|NCT01947153|P1|Participant Flow|Fixed Dose Combination First, Then Free Combination|5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet
43409|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43410|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43411|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43412|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43413|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43414|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43415|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43416|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43417|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43418|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43419|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43420|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43421|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43422|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43423|NCT01947153|E2|Reported Event|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
43424|NCT01947153|E1|Reported Event|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
43425|NCT01947127|B3|Baseline|Total|Total of all reporting groups
43426|NCT01947127|B2|Baseline|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43427|NCT01947127|B1|Baseline|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43428|NCT01947127|P2|Participant Flow|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43429|NCT01947127|P1|Participant Flow|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43430|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43431|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43432|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43433|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43434|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43435|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43436|NCT01947127|E2|Reported Event|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
43437|NCT01947127|E1|Reported Event|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
43438|NCT01946542|B3|Baseline|Total|Total of all reporting groups
43439|NCT01946542|B2|Baseline|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
43440|NCT01946542|B1|Baseline|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
43441|NCT01946542|P2|Participant Flow|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
43442|NCT01946542|P1|Participant Flow|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
43443|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
43444|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
43445|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
43446|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
43447|NCT01946542|E2|Reported Event|Beet Juice Concentrate|
43448|NCT01946542|E1|Reported Event|Placebo|
43449|NCT01946529|B4|Baseline|Total|Total of all reporting groups
43450|NCT01946529|B3|Baseline|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
43451|NCT01946529|B2|Baseline|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
43452|NCT01946529|B1|Baseline|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
43453|NCT01946529|P3|Participant Flow|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
43454|NCT01946529|P2|Participant Flow|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
43455|NCT01946529|P1|Participant Flow|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
43456|NCT01946529|O1|Outcome|Group B (High Risk) - ESFT|Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation.
43486|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43487|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43457|NCT01946529|E4|Reported Event|Group B (High Risk) - Total|"All Group B High Risk participants with ESFT or DSRCT.~Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation."
43458|NCT01946529|E3|Reported Event|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
43459|NCT01946529|E2|Reported Event|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
43460|NCT01946529|E1|Reported Event|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
43461|NCT01946438|B5|Baseline|Total|Total of all reporting groups
43462|NCT01946438|B4|Baseline|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43463|NCT01946438|B3|Baseline|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43464|NCT01946438|B2|Baseline|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43465|NCT01946438|B1|Baseline|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43466|NCT01946438|P4|Participant Flow|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43467|NCT01946438|P3|Participant Flow|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43468|NCT01946438|P2|Participant Flow|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43469|NCT01946438|P1|Participant Flow|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43470|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43471|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43472|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43473|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43474|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43475|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43476|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43477|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43478|NCT01946438|O4|Outcome|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43479|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43480|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43481|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43482|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43483|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43484|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43485|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
43546|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
43488|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43489|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43490|NCT01946438|E4|Reported Event|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43491|NCT01946438|E3|Reported Event|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43492|NCT01946438|E2|Reported Event|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
43493|NCT01946438|E1|Reported Event|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
43494|NCT01946425|B3|Baseline|Total|Total of all reporting groups
43495|NCT01946425|B2|Baseline|Age 3 to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
43496|NCT01946425|B1|Baseline|Age 6 to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
43497|NCT01946425|P2|Participant Flow|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
43498|NCT01946425|P1|Participant Flow|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
43499|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
43500|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43501|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43502|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43503|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43504|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43505|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43506|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43507|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43508|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
43509|NCT01946425|E2|Reported Event|Age 3 Years to <9 Years Group|Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
43510|NCT01946425|E1|Reported Event|Age 6 Months to <36 Months Group|Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
43511|NCT01946412|B1|Baseline|Ivacaftor|Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to < 6 years and weighing <14 kg, ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing >= 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
43512|NCT01946412|P1|Participant Flow|Ivacaftor|Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (<) 6 years and weighing <14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing greater than or equal to (>=) 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
43513|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43514|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43515|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43516|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43517|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43518|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43519|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43520|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43521|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43522|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43523|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43524|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43525|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43526|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43527|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43528|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43529|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43530|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43531|NCT01946412|E2|Reported Event|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43532|NCT01946412|E1|Reported Event|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
43533|NCT01946243|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
43534|NCT01946243|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
43535|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
43536|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
43537|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
43538|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
43539|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
43540|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
43541|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
43542|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
43543|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
43544|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
43545|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
43553|NCT01946243|E1|Reported Event|Florbetapir PET Scans|No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
43554|NCT01946178|B1|Baseline|All Treated Patients|All patients who underwent treatment with the device
43555|NCT01946178|P1|Participant Flow|All Treated Patients|All patients who underwent treatment with the device
43556|NCT01946178|O2|Outcome|Entire Validation Cohort|The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 36 patients in the Validation Cohort.
43557|NCT01946178|O1|Outcome|Entire Development Cohort|The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 37 patients in the Development Cohort.
43558|NCT01946178|O2|Outcome|Validation Cohort With NPVs Observed|"The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
43559|NCT01946178|O1|Outcome|Development Cohort With NPVs Observed|"The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 33 out of 37 patients (89.2%) in the Development Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
43560|NCT01946178|O1|Outcome|All Treated Patients|All patients who underwent treatment with the device
43561|NCT01946178|E1|Reported Event|All Treated Patients|All patients who underwent treatment with the device
43562|NCT01946126|B3|Baseline|Total|Total of all reporting groups
43563|NCT01946126|B2|Baseline|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43564|NCT01946126|B1|Baseline|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43565|NCT01946126|P2|Participant Flow|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43566|NCT01946126|P1|Participant Flow|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43567|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43568|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43569|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43570|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43571|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43572|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43573|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43574|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43575|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43576|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43577|NCT01946126|E2|Reported Event|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
43578|NCT01946126|E1|Reported Event|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
43579|NCT01945970|B1|Baseline|Study Subjects|All six treatment orders combined
43580|NCT01945970|P6|Participant Flow|Placebo - Black Tea - Positive Control|"Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.~Treatments each lasted one week and were separated by a one week washout."
43581|NCT01945970|P5|Participant Flow|Placebo- Positive Control - Black Tea|"Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.~Treatments each lasted one week and were separated by a one week washout."
43582|NCT01945970|P4|Participant Flow|Positive Control - Placebo - Black Tea|"Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.~Treatments each lasted one week and were separated by a one week washout."
43583|NCT01945970|P3|Participant Flow|Positive Control - Black Tea - Placebo|"Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
43584|NCT01945970|P2|Participant Flow|Black Tea - Placebo - Positive Control|"Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.~Treatments each lasted one week and were separated by a one week washout."
43585|NCT01945970|P1|Participant Flow|Black Tea - Positive Control - Placebo|"Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
43587|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43588|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43589|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43590|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43591|NCT01945970|O1|Outcome|Postive Control Beverage|Participant when they received the positive control
43592|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43593|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43594|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43595|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43596|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43597|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43598|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43599|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43600|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43601|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43602|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43603|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43604|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43605|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43606|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43607|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43608|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43609|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43610|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43611|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
43612|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43613|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
43614|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43615|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
43616|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
43617|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
43618|NCT01945970|E3|Reported Event|Placebo|Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
43619|NCT01945970|E2|Reported Event|Positive Control|Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
43620|NCT01945970|E1|Reported Event|Black Tea Extract|Spray dried aqueous extract of a representative batch of black tea
43621|NCT01945944|B3|Baseline|Total|Total of all reporting groups
43622|NCT01945944|B2|Baseline|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
43623|NCT01945944|B1|Baseline|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
43624|NCT01945944|P2|Participant Flow|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
43625|NCT01945944|P1|Participant Flow|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
43626|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43627|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43628|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43629|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43630|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43631|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43632|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43633|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43634|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43635|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43636|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43637|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43638|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
43639|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43640|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
44171|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
43641|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
43642|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
43643|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
43644|NCT01945944|E2|Reported Event|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
43645|NCT01945944|E1|Reported Event|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
43646|NCT01945294|B4|Baseline|Total|Total of all reporting groups
43647|NCT01945294|B3|Baseline|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43648|NCT01945294|B2|Baseline|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43649|NCT01945294|B1|Baseline|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43650|NCT01945294|P4|Participant Flow|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43651|NCT01945294|P3|Participant Flow|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43652|NCT01945294|P2|Participant Flow|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43653|NCT01945294|P1|Participant Flow|All Treated Participants|All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA]) or allocation to Arm 3 (participants with detectable HCV RNA).
43654|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
43655|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43656|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43657|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
43658|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43659|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43660|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
43661|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43662|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43663|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
43687|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
43688|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
43664|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43665|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43666|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43667|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43668|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43669|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43670|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43671|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43672|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43673|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43674|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43675|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
43676|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43677|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43678|NCT01945294|E3|Reported Event|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
43679|NCT01945294|E2|Reported Event|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
43680|NCT01945294|E1|Reported Event|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
43681|NCT01945242|B3|Baseline|Total|Total of all reporting groups
43682|NCT01945242|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
43683|NCT01945242|B1|Baseline|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
43684|NCT01945242|P2|Participant Flow|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
43685|NCT01945242|P1|Participant Flow|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
43686|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
44172|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
43689|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
43690|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
43691|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
43692|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
43693|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
43694|NCT01945242|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
43695|NCT01945242|E1|Reported Event|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
43696|NCT01945138|B3|Baseline|Total|Total of all reporting groups
43697|NCT01945138|B2|Baseline|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43698|NCT01945138|B1|Baseline|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43699|NCT01945138|P2|Participant Flow|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43700|NCT01945138|P1|Participant Flow|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43701|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43702|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43703|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43704|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43705|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43706|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43707|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43708|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43709|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43710|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43711|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43712|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43740|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43741|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
94275|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
43713|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43714|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43715|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43716|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43717|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43718|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43719|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43720|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43721|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43722|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43723|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43724|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43725|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43726|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43727|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43728|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43729|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43730|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43731|NCT01945138|E2|Reported Event|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
43732|NCT01945138|E1|Reported Event|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
43733|NCT01945086|B4|Baseline|Total|Total of all reporting groups
43734|NCT01945086|B3|Baseline|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43735|NCT01945086|B2|Baseline|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43736|NCT01945086|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43737|NCT01945086|P3|Participant Flow|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43738|NCT01945086|P2|Participant Flow|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43739|NCT01945086|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
44173|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
43742|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43743|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43744|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43745|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43746|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43747|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43748|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43749|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43750|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43751|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43752|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43753|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43754|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43755|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43756|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43757|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43758|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43759|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43760|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43761|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43762|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43763|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43764|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43765|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43766|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43767|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43768|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43769|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43770|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43771|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43772|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43773|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43774|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43775|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43776|NCT01945086|E3|Reported Event|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
43777|NCT01945086|E2|Reported Event|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
43778|NCT01945086|E1|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
43779|NCT01945034|B4|Baseline|Total|Total of all reporting groups
43780|NCT01945034|B3|Baseline|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43781|NCT01945034|B2|Baseline|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43782|NCT01945034|B1|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43783|NCT01945034|P3|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43784|NCT01945034|P2|Participant Flow|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43785|NCT01945034|P1|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43786|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43787|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43788|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43789|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43790|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43791|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43792|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43793|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43794|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43795|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43796|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43797|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43798|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43799|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43800|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43801|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43802|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43803|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43804|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43805|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43806|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43807|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43808|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43809|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43810|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43811|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43841|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
43812|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43813|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43814|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43815|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43816|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43817|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43818|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43819|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43820|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43821|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43822|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43823|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43824|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43825|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43826|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43827|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43828|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43829|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43830|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43831|NCT01945034|E3|Reported Event|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
43832|NCT01945034|E2|Reported Event|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43833|NCT01945034|E1|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
43834|NCT01945021|B1|Baseline|Crizotinib|Single arm trial whereby all consented, enrolled, eligible patients receive crizotinib
43835|NCT01945021|P1|Participant Flow|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
43836|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
43837|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
43838|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) included all enrolled patients who receive at least one dose of study medication. (n=127).
43839|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
43840|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
43842|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
43843|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
43844|NCT01945021|O1|Outcome|Participants With Objective Response by Independent Review|Defined as all patients in the safety analysis population who have an adequate baseline tumor assessment and an objective response determined by Independent Review (n=88).
43845|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
43846|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
43847|NCT01945021|E1|Reported Event|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
43848|NCT01944969|B1|Baseline|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43849|NCT01944969|P1|Participant Flow|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43850|NCT01944969|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43851|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43852|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43853|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43854|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally"
43855|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43856|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43857|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43858|NCT01944969|E1|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
43859|NCT01944878|B3|Baseline|Total|Total of all reporting groups
43860|NCT01944878|B2|Baseline|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43861|NCT01944878|B1|Baseline|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43862|NCT01944878|P2|Participant Flow|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43863|NCT01944878|P1|Participant Flow|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43864|NCT01944878|O2|Outcome|No PUD in Lchronic Hepatitis|
43865|NCT01944878|O1|Outcome|PUD in Chronic Hepatitis|
43866|NCT01944878|O2|Outcome|No PUD in Liver Cirrhosis|Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43867|NCT01944878|O1|Outcome|PUD in Liver Cirrhosis|Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43868|NCT01944878|E2|Reported Event|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43869|NCT01944878|E1|Reported Event|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
43870|NCT01944774|B4|Baseline|Total|Total of all reporting groups
43871|NCT01944774|B3|Baseline|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43872|NCT01944774|B2|Baseline|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43873|NCT01944774|B1|Baseline|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43874|NCT01944774|P3|Participant Flow|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43875|NCT01944774|P2|Participant Flow|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43876|NCT01944774|P1|Participant Flow|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43877|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43878|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43879|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43880|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43881|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43882|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43883|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43884|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43885|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43886|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43887|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43888|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43889|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43890|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43891|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43892|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43893|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43894|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43895|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43896|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43897|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43898|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43899|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43900|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43901|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
43902|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
43903|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
43904|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
43905|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
43906|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
43907|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
43908|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
43909|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
43910|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
43911|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
43912|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
43913|NCT01944774|E3|Reported Event|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
43914|NCT01944774|E2|Reported Event|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
43915|NCT01944774|E1|Reported Event|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
43916|NCT01944631|B3|Baseline|Total|Total of all reporting groups
43917|NCT01944631|B2|Baseline|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43918|NCT01944631|B1|Baseline|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43919|NCT01944631|P2|Participant Flow|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43920|NCT01944631|P1|Participant Flow|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43921|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43922|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43923|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43924|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43925|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43926|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43927|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43928|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43929|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43930|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43931|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43932|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43933|NCT01944631|E2|Reported Event|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43934|NCT01944631|E1|Reported Event|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
43935|NCT01944345|B1|Baseline|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43936|NCT01944345|P1|Participant Flow|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43937|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43938|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43939|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43940|NCT01944345|E1|Reported Event|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
43941|NCT01944319|B3|Baseline|Total|Total of all reporting groups
43942|NCT01944319|B2|Baseline|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
43943|NCT01944319|B1|Baseline|Control Group|Meropenem therapy with regimen routinely decided by attending physician
43944|NCT01944319|P2|Participant Flow|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
43945|NCT01944319|P1|Participant Flow|Control Group|Meropenem therapy with regimen routinely decided by attending physician
43946|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
43947|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
43948|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
43949|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
43950|NCT01944319|O2|Outcome|Study Group|The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
43951|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
43952|NCT01944319|E2|Reported Event|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
43953|NCT01944319|E1|Reported Event|Control Group|The participants in control group will accept routine meropenem therapy.
43954|NCT01944059|B1|Baseline|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
43955|NCT01944059|P1|Participant Flow|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
43956|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
43957|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
43958|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
43977|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43959|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
43960|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
43961|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
43962|NCT01944059|E1|Reported Event|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
43963|NCT01943864|B1|Baseline|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43964|NCT01943864|P1|Participant Flow|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43965|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43966|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43967|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43968|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43969|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43970|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43971|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43972|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43973|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43974|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43975|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43976|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
44005|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
94276|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
43978|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43979|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43980|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43981|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43982|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43983|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43984|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43985|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43986|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43987|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43988|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43989|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43990|NCT01943864|E1|Reported Event|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
43991|NCT01943552|B3|Baseline|Total|Total of all reporting groups
43992|NCT01943552|B2|Baseline|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
43993|NCT01943552|B1|Baseline|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
43994|NCT01943552|P2|Participant Flow|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
43995|NCT01943552|P1|Participant Flow|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
43996|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
43997|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
43998|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
43999|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
44000|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
44001|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
44002|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
44003|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
44004|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
44174|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
44006|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
44007|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
44008|NCT01943552|E2|Reported Event|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
44009|NCT01943552|E1|Reported Event|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
44010|NCT01943344|B1|Baseline|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
44011|NCT01943344|P1|Participant Flow|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
44012|NCT01943344|O1|Outcome|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
44013|NCT01943344|E1|Reported Event|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
44014|NCT01943292|B4|Baseline|Total|Total of all reporting groups
44015|NCT01943292|B3|Baseline|Defactinib 600 mg Bid|600 mg po bid defactinib
44016|NCT01943292|B2|Baseline|Defactinib 400 mg Bid|400 mg po bid defactinib
44017|NCT01943292|B1|Baseline|Defactinib 200 mg Bid|200 mg po bid defactinib
44018|NCT01943292|P3|Participant Flow|Defactinib 600 mg Bid|600 mg bid po defactinib
44019|NCT01943292|P2|Participant Flow|Defactinib 400 mg Bid|400 mg bid po defactinib
44020|NCT01943292|P1|Participant Flow|Defactinib 200 mg Bid|200 mg bid (twice a day) po (by mouth) defactinib
44021|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
44022|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
44023|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
44024|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
44025|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
44026|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
44027|NCT01943292|E3|Reported Event|Defactinib 600 mg Bid|600 mg po bid defactinib
44028|NCT01943292|E2|Reported Event|Defactinib 400 mg Bid|400 mg po bid defactinib
44029|NCT01943292|E1|Reported Event|Defactinib 200 mg Bid|200 mg po bid defactinib
44030|NCT01943110|B1|Baseline|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
44031|NCT01943110|P1|Participant Flow|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
44032|NCT01943110|O2|Outcome|SLA ID Adapter|Injections given with the side-load ID adapter
44033|NCT01943110|O1|Outcome|AD ID Adapter|Injections given with the autodisable ID adapter
44034|NCT01943110|O6|Outcome|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
44035|NCT01943110|O5|Outcome|SLA Forearm|Injections given with the side-load ID adapter in the forearm
44036|NCT01943110|O4|Outcome|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
44037|NCT01943110|O3|Outcome|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
44038|NCT01943110|O2|Outcome|ADID Forearm|Injections given with the autodisable ID adapter in the forearm
44039|NCT01943110|O1|Outcome|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
44040|NCT01943110|E6|Reported Event|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
44041|NCT01943110|E5|Reported Event|SLA Forearm|Injections given with the side-load ID adapter in the forearm region
44042|NCT01943110|E4|Reported Event|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
44043|NCT01943110|E3|Reported Event|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
44044|NCT01943110|E2|Reported Event|ADID Forearm|Injections given with the autodisable ID adapter in the forearm region
44045|NCT01943110|E1|Reported Event|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
44046|NCT01942785|B1|Baseline|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44047|NCT01942785|P1|Participant Flow|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44048|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
44049|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
44050|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole:2-3 mg/day, once daily dose, tablets, for oral use"
44051|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44052|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44053|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44054|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44055|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44056|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44057|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44058|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44059|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44060|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44061|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44062|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44063|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44064|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44065|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44066|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44067|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44068|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44069|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44070|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44071|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44072|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44073|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
44074|NCT01942785|E1|Reported Event|Brexpiprazole|Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use
44075|NCT01942733|B1|Baseline|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44076|NCT01942733|P1|Participant Flow|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44077|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44078|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44079|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44080|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44081|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44175|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44082|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44083|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44084|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44085|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44086|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44087|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44088|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44089|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44090|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44091|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44092|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44093|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44094|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44095|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44096|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44097|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44098|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44099|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44100|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44101|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44102|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
44103|NCT01942733|E1|Reported Event|Brexpiprazole|The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
44104|NCT01942135|B3|Baseline|Total|Total of all reporting groups
44105|NCT01942135|B2|Baseline|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44106|NCT01942135|B1|Baseline|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44107|NCT01942135|P2|Participant Flow|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44108|NCT01942135|P1|Participant Flow|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44163|NCT01941498|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44176|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44109|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44110|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44111|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44112|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44113|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44114|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44115|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44116|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44117|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44118|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44119|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44120|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44121|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44164|NCT01941498|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44165|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44122|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44123|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44124|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44125|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44126|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44127|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44128|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44129|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44130|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44131|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44132|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44133|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44134|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44166|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44167|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44135|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44136|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44137|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44138|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44139|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44140|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44141|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44142|NCT01942135|E2|Reported Event|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44143|NCT01942135|E1|Reported Event|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
44144|NCT01941940|B1|Baseline|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44145|NCT01941940|P1|Participant Flow|Tocilizumab|Tocilizumab at a fixed dose of 162 milligrams (mg) was administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological Disease-Modifying Antirheumatic Drugs (DMARDs) irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44146|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44147|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44148|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44149|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44150|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44151|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44152|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
44153|NCT01941940|E1|Reported Event|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it become commercially available in Italy (maximum up to 2 years and 10 months).
44154|NCT01941615|B1|Baseline|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44155|NCT01941615|P1|Participant Flow|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44156|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44157|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44158|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44159|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44160|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44161|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
44162|NCT01941615|E1|Reported Event|Deleobuvir + Faldaprevir + Microgynon|"In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.~In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.~Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days."
44168|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44177|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44178|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44179|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44180|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44181|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44182|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44183|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44184|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44185|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44186|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44187|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44188|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44189|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44190|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
44191|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44192|NCT01941498|O2|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal ablation
44193|NCT01941498|O1|Outcome|EX500 Laser|Excimer 500 laser used during LASIK surgery for corneal ablation
44194|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44195|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44196|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44197|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44198|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44199|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44200|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44201|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
44202|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44203|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44204|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44205|NCT01941498|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
44206|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44207|NCT01941498|E2|Reported Event|Screen Failure|Prior to treatment
44208|NCT01941498|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
44209|NCT01941485|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44210|NCT01941485|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44211|NCT01941485|O1|Outcome|Angles|WaveLight Refractive Suite
44212|NCT01941485|O1|Outcome|AC Depth|WaveLight Refractive Suite
44213|NCT01941485|O1|Outcome|AC Volume|WaveLight Refractive Suite
44214|NCT01941485|O1|Outcome|Q-Value|WaveLight Refractive Suite
44215|NCT01941485|O1|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal flap creation
44216|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44217|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44218|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44219|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44220|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44221|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44222|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44223|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44224|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44225|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44226|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44227|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44228|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44229|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44230|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44231|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44232|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44233|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44234|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44235|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44236|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44237|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44238|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44239|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44240|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44241|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44242|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44243|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44244|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
44245|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44246|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44247|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44248|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44249|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
44250|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
44251|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44252|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44253|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44254|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44255|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44256|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44257|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44258|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44259|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44260|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44261|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44262|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
44263|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44264|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
44265|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
44266|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
44267|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
44268|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
44269|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
44270|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44271|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44272|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44273|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44274|NCT01941485|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
44275|NCT01941186|B3|Baseline|Total|Total of all reporting groups
44276|NCT01941186|B2|Baseline|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
44277|NCT01941186|B1|Baseline|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44278|NCT01941186|P2|Participant Flow|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
44279|NCT01941186|P1|Participant Flow|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44280|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
44281|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44282|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
44283|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44284|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
44285|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44286|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
44354|NCT01940146|B4|Baseline|SPARC1310 III|S0597 high dose: S0597 high dose
44355|NCT01940146|B3|Baseline|SPARC1310 II|S0597 mid dose: S0597 mid dose
44356|NCT01940146|B2|Baseline|SPARC1310 I|Baseline characteristics: Age
44357|NCT01940146|B1|Baseline|SPARC Placebo|Baseline characteristics: Age
44287|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44288|NCT01941186|O12|Outcome|Routine Care: Strongly Agree|"Percentage of parents who answered strongly agree to questions during pre and post intervention"
44289|NCT01941186|O11|Outcome|Routine Care: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
44290|NCT01941186|O10|Outcome|Routine Care: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention."
44291|NCT01941186|O9|Outcome|Routine Care: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post intervention"
44292|NCT01941186|O8|Outcome|Routine Care: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
44293|NCT01941186|O7|Outcome|Routine Care: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
44294|NCT01941186|O6|Outcome|Patient Decision Aid: Strongly Agree|"Percentage of parents who answered Strongly Agree to questions during pre and post intervention"
44295|NCT01941186|O5|Outcome|Patient Decision Aid: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
44296|NCT01941186|O4|Outcome|Patient Decision Aid: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention"
44297|NCT01941186|O3|Outcome|Patient Decision Aid: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post"
44298|NCT01941186|O2|Outcome|Patient Decision Aid: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
44299|NCT01941186|O1|Outcome|Patient Decision Aid: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
44300|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
44301|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44302|NCT01941186|E2|Reported Event|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
44303|NCT01941186|E1|Reported Event|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
44304|NCT01940510|B1|Baseline|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
44305|NCT01940510|P1|Participant Flow|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
44306|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44307|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44308|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44309|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44310|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44311|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
94277|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
44312|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44313|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44314|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44315|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44316|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44317|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44318|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44319|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44320|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44321|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44322|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44323|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44324|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44325|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44326|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44327|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44328|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44329|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44358|NCT01940146|P4|Participant Flow|SPARC1310 III|SPARC1310 III was administered as two sprays/nostril QD
44359|NCT01940146|P3|Participant Flow|SPARC1310 II|SPARC1310 II was administered as two sprays/nostril QD
44330|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44331|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44332|NCT01940510|E3|Reported Event|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
44333|NCT01940510|E2|Reported Event|Treatment Period 2: Rifampin|Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
44334|NCT01940510|E1|Reported Event|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
44335|NCT01940484|B1|Baseline|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44336|NCT01940484|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44337|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44338|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44339|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44340|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44341|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44342|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44343|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44344|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44345|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44346|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44347|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44348|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44349|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44350|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44351|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44352|NCT01940484|E1|Reported Event|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
44353|NCT01940146|B5|Baseline|Total|Total of all reporting groups
44360|NCT01940146|P2|Participant Flow|SPARC1310 I|SPARC1310 I was administered as two sprays /nostril QD
44361|NCT01940146|P1|Participant Flow|SPARC Placebo|SPARC Placebo was administered as sprays/nostril QD
44362|NCT01940146|O4|Outcome|S0597 High Dose|S0597 high dose: S0597 high dose
44363|NCT01940146|O3|Outcome|S0597 Mid Dose|S0597 mid dose: S0597 mid dose
44364|NCT01940146|O2|Outcome|S0597 Low Dose|S0597 low dose: S0597 low dose
44365|NCT01940146|O1|Outcome|Placebo|Placebo: Placebo
44366|NCT01940146|E4|Reported Event|SPARC1310 III|SPARC1310 III administration
44367|NCT01940146|E3|Reported Event|SPARC1310 II|SPARC1310 II administration
44368|NCT01940146|E2|Reported Event|SPARC1310 I|SPARC1310 I administration
44369|NCT01940146|E1|Reported Event|SPARC Placebo|SPARC Placebo administration
44370|NCT01940120|B1|Baseline|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44371|NCT01940120|P1|Participant Flow|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44372|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44373|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44374|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44375|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44376|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44377|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44378|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44379|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44380|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44381|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44382|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44383|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44384|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44385|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44579|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44631|NCT01939314|O2|Outcome|Normal Saline|Normal Saline .03ml to each nare
44386|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44387|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44388|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44389|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44390|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44391|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44392|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44393|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44394|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44395|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44396|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44397|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44398|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44399|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44400|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44401|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44402|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44403|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44404|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44626|NCT01939314|P1|Participant Flow|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
44405|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44406|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44407|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44408|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44409|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44410|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44411|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44412|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44413|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44414|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44415|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44416|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44417|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44418|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44419|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44420|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44421|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44422|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44423|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44627|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
44424|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44425|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44426|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44427|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44428|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44429|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44430|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44431|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44432|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44433|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44434|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44435|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44436|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44437|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44438|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44439|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44440|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44441|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44442|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44628|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
44443|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44444|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44445|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44446|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44447|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44448|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44449|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44450|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44451|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44452|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44453|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44454|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44455|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44456|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44457|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44458|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44459|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44460|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44461|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44629|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
44462|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44463|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44464|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44465|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44466|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44467|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44468|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44469|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44470|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44471|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44472|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44473|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44474|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44475|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44476|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44477|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44478|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44479|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44480|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44630|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
44481|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44482|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44483|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44484|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44485|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44486|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44487|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44488|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44489|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
44490|NCT01940120|E1|Reported Event|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.~Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve"
44491|NCT01939548|B4|Baseline|Total|Total of all reporting groups
44492|NCT01939548|B3|Baseline|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44493|NCT01939548|B2|Baseline|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44494|NCT01939548|B1|Baseline|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44495|NCT01939548|P3|Participant Flow|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44496|NCT01939548|P2|Participant Flow|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44497|NCT01939548|P1|Participant Flow|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44498|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44499|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44500|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44501|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44502|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44503|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44504|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44505|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44506|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44507|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44508|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44509|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44510|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44511|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44512|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44513|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44514|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44515|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44516|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44517|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44518|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44519|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44520|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44521|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44522|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44523|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44524|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44525|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44526|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44527|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44528|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44529|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44530|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44531|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44532|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44533|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44534|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44535|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44536|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44537|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44538|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44539|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44540|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44541|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44542|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44543|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44544|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44545|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44546|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44547|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44548|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44549|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44550|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44551|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44552|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44553|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44554|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44555|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44556|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44557|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44558|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44559|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44560|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44561|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44562|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44563|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44564|NCT01939548|E3|Reported Event|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44565|NCT01939548|E2|Reported Event|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44566|NCT01939548|E1|Reported Event|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
44567|NCT01939496|B4|Baseline|Total|Total of all reporting groups
44568|NCT01939496|B3|Baseline|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44569|NCT01939496|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44570|NCT01939496|B1|Baseline|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44571|NCT01939496|P3|Participant Flow|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44572|NCT01939496|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44573|NCT01939496|P1|Participant Flow|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44574|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44575|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44576|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44577|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44578|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44632|NCT01939314|O1|Outcome|Bupivacaine|Bupivicaine .03ml to each nare
44580|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44581|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44582|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44583|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44584|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44585|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44586|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44587|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44588|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44589|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44590|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44591|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44592|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44593|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44594|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44595|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44596|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44597|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44598|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44599|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44600|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44601|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44602|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44603|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44604|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44605|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44606|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44607|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44608|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44609|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44610|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44611|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44612|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44613|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44614|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44615|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44616|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44617|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44618|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44619|NCT01939496|E3|Reported Event|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
44620|NCT01939496|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
44621|NCT01939496|E1|Reported Event|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
44622|NCT01939314|B3|Baseline|Total|Total of all reporting groups
44623|NCT01939314|B2|Baseline|Normal Saline|Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
44624|NCT01939314|B1|Baseline|Bupivacaine|Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
44625|NCT01939314|P2|Participant Flow|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
44633|NCT01939314|E2|Reported Event|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
44634|NCT01939314|E1|Reported Event|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
44635|NCT01939145|B3|Baseline|Total|Total of all reporting groups
44636|NCT01939145|B2|Baseline|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
44637|NCT01939145|B1|Baseline|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
44638|NCT01939145|P2|Participant Flow|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
44639|NCT01939145|P1|Participant Flow|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
44640|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
44641|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
44642|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
44643|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
44644|NCT01939145|E2|Reported Event|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
44645|NCT01939145|E1|Reported Event|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
44646|NCT01939002|B3|Baseline|Total|Total of all reporting groups
44647|NCT01939002|B2|Baseline|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44648|NCT01939002|B1|Baseline|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44649|NCT01939002|P2|Participant Flow|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44650|NCT01939002|P1|Participant Flow|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44651|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44652|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44653|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44654|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44655|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44656|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44657|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
44658|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
44659|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44660|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44661|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44722|NCT01938430|B15|Baseline|Total|Total of all reporting groups
44662|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44663|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44664|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44665|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44666|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44667|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44668|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44669|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44670|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44671|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44672|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44673|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44674|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44723|NCT01938430|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44795|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44675|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44676|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44677|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44678|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44679|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44680|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44681|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44682|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44683|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44684|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44685|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44686|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44687|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44688|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
45510|NCT01937130|E3|Reported Event|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
44689|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44690|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44691|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44692|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44693|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44694|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44695|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44696|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44697|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44698|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44699|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44700|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44701|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44724|NCT01938430|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45113|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
44702|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44703|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44704|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44705|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44706|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44707|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
44708|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44709|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44710|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
44711|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
44712|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently."
44713|NCT01939002|E2|Reported Event|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
44714|NCT01939002|E1|Reported Event|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
44715|NCT01938989|B1|Baseline|Overall|Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
44716|NCT01938989|P2|Participant Flow|Blue Light Filter, Then Clear|Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
44717|NCT01938989|P1|Participant Flow|Clear, Then Blue Light Filter|Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
44718|NCT01938989|O2|Outcome|Clear|Clear clip-on glasses worn over habitual correction
44719|NCT01938989|O1|Outcome|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
44720|NCT01938989|E2|Reported Event|Clear|Clear clip-on glasses worn over habitual correction
44721|NCT01938989|E1|Reported Event|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
44725|NCT01938430|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44726|NCT01938430|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44727|NCT01938430|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44728|NCT01938430|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44729|NCT01938430|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44730|NCT01938430|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44731|NCT01938430|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44732|NCT01938430|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44733|NCT01938430|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44734|NCT01938430|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44735|NCT01938430|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44736|NCT01938430|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44737|NCT01938430|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44738|NCT01938430|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44739|NCT01938430|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44740|NCT01938430|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44741|NCT01938430|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44742|NCT01938430|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44743|NCT01938430|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44744|NCT01938430|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44745|NCT01938430|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44746|NCT01938430|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis"
44747|NCT01938430|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44748|NCT01938430|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44749|NCT01938430|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44750|NCT01938430|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
44751|NCT01938430|O11|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44752|NCT01938430|O10|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44753|NCT01938430|O9|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44754|NCT01938430|O8|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44755|NCT01938430|O7|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44756|NCT01938430|O6|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44757|NCT01938430|O5|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44758|NCT01938430|O4|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44759|NCT01938430|O3|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44760|NCT01938430|O2|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44761|NCT01938430|O1|Outcome|Cohort A: Baseline CPT Class A (24 wk)|Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
44762|NCT01938430|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44763|NCT01938430|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44764|NCT01938430|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44765|NCT01938430|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44766|NCT01938430|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44767|NCT01938430|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44768|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44769|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44770|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45511|NCT01937130|E2|Reported Event|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
44771|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44772|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44773|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44774|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44775|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44776|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44777|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44778|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44779|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44780|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44781|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44782|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44783|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44784|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44785|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44786|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44787|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44788|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44789|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44790|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44791|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44792|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44793|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44794|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44796|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44797|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44798|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44799|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44800|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44801|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44802|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44803|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44804|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44805|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44806|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44807|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44808|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44809|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44810|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44811|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44812|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44813|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44814|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44815|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44816|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44817|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44818|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45114|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
44819|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44820|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44821|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44822|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44823|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44824|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44825|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44826|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44827|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44828|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44829|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44830|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44831|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44832|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44833|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44834|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44835|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44836|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44837|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44838|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44839|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44840|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44841|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44842|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44843|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44844|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44845|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44846|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44847|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44848|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44849|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44850|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44851|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44852|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44853|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44854|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44855|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44856|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44857|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44858|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44859|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44860|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44861|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44862|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44863|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44864|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44865|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44914|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44866|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44867|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44868|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44869|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44870|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44871|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44872|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44873|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44874|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44875|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44876|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44877|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44878|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44879|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44880|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44881|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44882|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44883|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44884|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44885|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44886|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44887|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44888|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44889|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44890|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44891|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44892|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44893|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44894|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44895|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44896|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44897|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44898|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44899|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44900|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44901|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44902|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44903|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44904|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44905|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44906|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44907|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44908|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44909|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44910|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44911|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44912|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44913|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44915|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44916|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44917|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44918|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44919|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44920|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44921|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44922|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44923|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44924|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44925|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44926|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44927|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44928|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44929|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44930|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44931|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44932|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44933|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44934|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44935|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44936|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44937|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45109|NCT01938040|O1|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
44938|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44939|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44940|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44941|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44942|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44943|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44944|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44945|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44946|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44947|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44948|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44949|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44950|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44951|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44952|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44953|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44954|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44955|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44956|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44957|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44958|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44959|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44960|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44961|NCT01938430|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
45512|NCT01937130|E1|Reported Event|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
44962|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44963|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44964|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44965|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44966|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44967|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44968|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44969|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44970|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44971|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
44972|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44973|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44974|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44975|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44976|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44977|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44978|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44979|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44980|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44981|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44982|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44983|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44984|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44985|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45513|NCT01936181|B3|Baseline|Total|Total of all reporting groups
44986|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44987|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44988|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44989|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44990|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
44991|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
44992|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
44993|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
44994|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
44995|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
44996|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
44997|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
44998|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
44999|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45000|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45001|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45002|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45003|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45004|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
45005|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45006|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45007|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45008|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45110|NCT01938040|O2|Outcome|Sugar Water|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45009|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45010|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
45011|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
45012|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
45013|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45014|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45015|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45016|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45017|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45018|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
45019|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45020|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45021|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45022|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45023|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45024|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
45025|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
45026|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
45027|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45028|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45029|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45030|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45031|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45032|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
45033|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45034|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45035|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45036|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45037|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45038|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
45039|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
45040|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
45041|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45042|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45043|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45044|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45045|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45046|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
45047|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45048|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45049|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45050|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45051|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45052|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
45053|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
45054|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
45055|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45056|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45057|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45058|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45059|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45060|NCT01938430|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
45061|NCT01938430|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
45062|NCT01938430|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45063|NCT01938430|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45064|NCT01938430|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45065|NCT01938430|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45066|NCT01938430|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
45067|NCT01938430|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
45068|NCT01938430|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
45069|NCT01938430|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
45070|NCT01938430|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
45071|NCT01938430|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
45072|NCT01938430|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
45073|NCT01938430|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
45074|NCT01938170|B1|Baseline|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
45075|NCT01938170|P1|Participant Flow|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
45076|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
45077|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
45078|NCT01938170|E1|Reported Event|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
45079|NCT01938079|B3|Baseline|Total|Total of all reporting groups
45080|NCT01938079|B2|Baseline|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45081|NCT01938079|B1|Baseline|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45111|NCT01938040|O1|Outcome|Ibuprofen|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45112|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45082|NCT01938079|P2|Participant Flow|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45083|NCT01938079|P1|Participant Flow|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45084|NCT01938079|O2|Outcome|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45085|NCT01938079|O1|Outcome|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45086|NCT01938079|E2|Reported Event|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45087|NCT01938079|E1|Reported Event|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
45088|NCT01938066|B3|Baseline|Total|Total of all reporting groups
45089|NCT01938066|B2|Baseline|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
45090|NCT01938066|B1|Baseline|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
45091|NCT01938066|P2|Participant Flow|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
45092|NCT01938066|P1|Participant Flow|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
45093|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
45094|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
45095|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
45096|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
45097|NCT01938066|E2|Reported Event|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
45098|NCT01938066|E1|Reported Event|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
45099|NCT01938040|B3|Baseline|Total|Total of all reporting groups
45100|NCT01938040|B2|Baseline|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45101|NCT01938040|B1|Baseline|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45102|NCT01938040|P2|Participant Flow|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
45103|NCT01938040|P1|Participant Flow|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
45104|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
45105|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
45106|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
45107|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
45108|NCT01938040|O2|Outcome|Ibuprofen|800 mg in 100mL of normal saline over 5 minutes
94278|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
45115|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45116|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45117|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45118|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45119|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45120|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45121|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45122|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45123|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45124|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
45125|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
45126|NCT01938040|E2|Reported Event|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
45127|NCT01938040|E1|Reported Event|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
45128|NCT01937975|B4|Baseline|Total|Total of all reporting groups
45129|NCT01937975|B3|Baseline|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45130|NCT01937975|B2|Baseline|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45131|NCT01937975|B1|Baseline|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45132|NCT01937975|P3|Participant Flow|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45133|NCT01937975|P2|Participant Flow|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45134|NCT01937975|P1|Participant Flow|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45135|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
45136|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45137|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45138|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45139|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45140|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45141|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
45142|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45143|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45144|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45145|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45231|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
49857|NCT01900067|O1|Outcome|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
45146|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45147|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45148|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45149|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45150|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45151|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45152|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45153|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45154|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45155|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45156|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
45157|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45158|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45159|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45160|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45161|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45162|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
45163|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45164|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45165|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45166|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45167|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45168|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45169|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45861|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45170|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45171|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45172|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45173|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45174|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45175|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45176|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
45177|NCT01937975|E3|Reported Event|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45178|NCT01937975|E2|Reported Event|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45179|NCT01937975|E1|Reported Event|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
45180|NCT01937871|B4|Baseline|Total|Total of all reporting groups
45181|NCT01937871|B3|Baseline|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45182|NCT01937871|B2|Baseline|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45183|NCT01937871|B1|Baseline|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45184|NCT01937871|P3|Participant Flow|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
45185|NCT01937871|P2|Participant Flow|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45186|NCT01937871|P1|Participant Flow|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45187|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45188|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45189|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45190|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45191|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
45192|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45193|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45194|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
45195|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45196|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45197|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45198|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45593|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45199|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45200|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45201|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45202|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45203|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45204|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45205|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
45206|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45207|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45208|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45209|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45210|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45211|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
45212|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45213|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45214|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45215|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45216|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45217|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45218|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45219|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45220|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45221|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45222|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45223|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45224|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45225|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45226|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45227|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45228|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45229|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45230|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45232|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45233|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
45234|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45235|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45236|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
45237|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45238|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45239|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45240|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45241|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45242|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45243|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45244|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45245|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45246|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45247|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45248|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45249|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45250|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45251|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45252|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45253|NCT01937871|E3|Reported Event|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
45254|NCT01937871|E2|Reported Event|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
45255|NCT01937871|E1|Reported Event|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
45256|NCT01937715|B6|Baseline|Total|Total of all reporting groups
45257|NCT01937715|B5|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45258|NCT01937715|B4|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45259|NCT01937715|B3|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45260|NCT01937715|B2|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45261|NCT01937715|B1|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45901|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45262|NCT01937715|P5|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45263|NCT01937715|P4|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45264|NCT01937715|P3|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45265|NCT01937715|P2|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45266|NCT01937715|P1|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45267|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45268|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45269|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45270|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45271|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45272|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45273|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45274|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45275|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45276|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45277|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45278|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45279|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45280|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45281|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45282|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45283|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45594|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45284|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45285|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45286|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45287|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45288|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45289|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45290|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45291|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45292|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45293|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45294|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45295|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45296|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45297|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45298|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45299|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45300|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45301|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45302|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45303|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45304|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45305|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45436|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45306|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45307|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45308|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45309|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45310|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45311|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45312|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45313|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45314|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45315|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45316|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45317|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45318|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45319|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45320|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45321|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45322|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45323|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45324|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45325|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45326|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45327|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45437|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
46822|NCT01924767|B3|Baseline|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
45328|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45329|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45330|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45331|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45332|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45333|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45334|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45335|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45336|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45337|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45338|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45339|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45340|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45341|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45342|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45343|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45344|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45345|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45346|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45347|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45348|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45349|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45438|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45350|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45351|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45352|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45353|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45354|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45355|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45356|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45357|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45358|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45359|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45360|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45361|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45362|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45363|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45364|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45365|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45366|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45367|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45368|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45369|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45370|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45371|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45439|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
48025|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
45372|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45373|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45374|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45375|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45376|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45377|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45378|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45379|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45380|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45381|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45382|NCT01937715|E5|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45383|NCT01937715|E4|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45384|NCT01937715|E3|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45385|NCT01937715|E2|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
45386|NCT01937715|E1|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
45387|NCT01937598|B1|Baseline|All Study Participants|All study participants (cross-over design) received all interventions.
45388|NCT01937598|P2|Participant Flow|Placebo, Than Sitagliptin|Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
45389|NCT01937598|P1|Participant Flow|Sitagliptin, Then Placebo|Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
45390|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45391|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45440|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45392|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45393|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45394|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45395|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45396|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45397|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45398|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45399|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45441|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
45442|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45443|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
45400|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45401|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45402|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45403|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45404|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45405|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45406|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45407|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45444|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45445|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
45595|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45408|NCT01937598|E2|Reported Event|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45409|NCT01937598|E1|Reported Event|Sitagliptin|"Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
45410|NCT01937520|B3|Baseline|Total|Total of all reporting groups
45411|NCT01937520|B2|Baseline|Sham/Placebo|"no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group~no acupuncture: placebo"
45412|NCT01937520|B1|Baseline|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45413|NCT01937520|P2|Participant Flow|Sham|"no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group~no acupuncture: placebo"
45414|NCT01937520|P1|Participant Flow|Acupuncture|"acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45415|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45416|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45417|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45418|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45419|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45420|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45421|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45422|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45423|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45424|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45425|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45426|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45427|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
45428|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45429|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45430|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45431|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45432|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45433|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
45434|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45435|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45446|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45447|NCT01937520|E2|Reported Event|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
45448|NCT01937520|E1|Reported Event|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
45449|NCT01937312|B3|Baseline|Total|Total of all reporting groups
45450|NCT01937312|B2|Baseline|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45451|NCT01937312|B1|Baseline|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45452|NCT01937312|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45453|NCT01937312|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45454|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45455|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45456|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45457|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45458|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45459|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45460|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45461|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45462|NCT01937312|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45463|NCT01937312|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
45464|NCT01937312|E1|Reported Event|Pre-Treatment|Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period
45465|NCT01937299|B3|Baseline|Total|Total of all reporting groups
45466|NCT01937299|B2|Baseline|Vehicle|1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004%
45467|NCT01937299|B1|Baseline|SIMBRINZA|1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004%
45468|NCT01937299|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45469|NCT01937299|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45470|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45471|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45472|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45473|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45474|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45475|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
45476|NCT01937299|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
45477|NCT01937299|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
45478|NCT01937299|E1|Reported Event|Pre-Treatment|Travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 4-week run-in period
45479|NCT01937130|B5|Baseline|Total|Total of all reporting groups
45480|NCT01937130|B4|Baseline|Placebo|"Dosed twice daily~Placebo"
45481|NCT01937130|B3|Baseline|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
45482|NCT01937130|B2|Baseline|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
45483|NCT01937130|B1|Baseline|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
45484|NCT01937130|P4|Participant Flow|Placebo|"Dosed twice daily~Placebo"
45485|NCT01937130|P3|Participant Flow|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
45486|NCT01937130|P2|Participant Flow|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
45487|NCT01937130|P1|Participant Flow|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
45488|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
45489|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
45490|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
45491|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
45492|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
45493|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
45514|NCT01936181|B2|Baseline|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
45515|NCT01936181|B1|Baseline|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45516|NCT01936181|P4|Participant Flow|Remicade (Infliximab), Continue as Remicade|"Remicade 3mg/kg at week 54, 62, 70~Remicade (infliximab)"
45517|NCT01936181|P3|Participant Flow|Remicade (Infliximab), Switch to SB2|"SB2 3mg/kg at week 54, 62, 70~SB2 (proposed biosimilar to infliximab)"
45518|NCT01936181|P2|Participant Flow|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
45519|NCT01936181|P1|Participant Flow|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45520|NCT01936181|O5|Outcome|Remicade (Infliximab), Continue as Remicade|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70."
45521|NCT01936181|O4|Outcome|Remicade (Infliximab), Switch to SB2 at Week 78|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.~SB2 (proposed biosimilar to infliximab)"
45522|NCT01936181|O3|Outcome|SB2 at Week 78|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45523|NCT01936181|O2|Outcome|Remicade (Infliximab) at Week 54|Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
45524|NCT01936181|O1|Outcome|SB2 at Week 54|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45525|NCT01936181|O2|Outcome|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
45526|NCT01936181|O1|Outcome|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45527|NCT01936181|E2|Reported Event|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
45528|NCT01936181|E1|Reported Event|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
45529|NCT01936896|B1|Baseline|Alpha-1 Anti-trypsin (AAT)|Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
45530|NCT01936896|P1|Participant Flow|Alpha-1 Anti-trypsin (AAT)|Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
45531|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
45532|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
45533|NCT01936896|E1|Reported Event|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
45534|NCT01936844|B3|Baseline|Total|Total of all reporting groups
45535|NCT01936844|B2|Baseline|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45536|NCT01936844|B1|Baseline|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45537|NCT01936844|P2|Participant Flow|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45538|NCT01936844|P1|Participant Flow|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45539|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45540|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45541|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45542|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45543|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45544|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45545|NCT01936844|E2|Reported Event|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
45546|NCT01936844|E1|Reported Event|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
45547|NCT01936662|B3|Baseline|Total|Total of all reporting groups
45548|NCT01936662|B2|Baseline|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
45549|NCT01936662|B1|Baseline|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
45550|NCT01936662|P2|Participant Flow|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
45551|NCT01936662|P1|Participant Flow|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
45552|NCT01936662|O2|Outcome|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
45553|NCT01936662|O1|Outcome|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
45554|NCT01936662|O2|Outcome|Endotracheal Tube for EGD Procedure|"Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital~ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital"
45555|NCT01936662|O1|Outcome|Largyngeal Mask Airway for EGD Procedure|"Patients randomized to LMA to maintain airway through EGD procedure~LMA: Patients randomized to the LMA group had their airways maintained with a LMA device"
45556|NCT01936662|E2|Reported Event|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
45557|NCT01936662|E1|Reported Event|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
45558|NCT01936649|B1|Baseline|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
45559|NCT01936649|P1|Participant Flow|AdreView (Iobenguane I 123 Injection)|Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
45560|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
45561|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
45562|NCT01936649|E1|Reported Event|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
45563|NCT01936389|B3|Baseline|Total|Total of all reporting groups
45564|NCT01936389|B2|Baseline|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
45565|NCT01936389|B1|Baseline|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
45566|NCT01936389|P2|Participant Flow|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
45567|NCT01936389|P1|Participant Flow|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
45568|NCT01936389|O2|Outcome|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
45569|NCT01936389|O1|Outcome|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
45570|NCT01936389|E2|Reported Event|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
45571|NCT01936389|E1|Reported Event|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
45572|NCT01935622|B4|Baseline|Total|Total of all reporting groups
45573|NCT01935622|B3|Baseline|Placebo|"Placebo~placebo"
45574|NCT01935622|B2|Baseline|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
45575|NCT01935622|B1|Baseline|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
45576|NCT01935622|P3|Participant Flow|Placebo|"Placebo~placebo"
45577|NCT01935622|P2|Participant Flow|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
45578|NCT01935622|P1|Participant Flow|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
45579|NCT01935622|O3|Outcome|Placebo|"Placebo~placebo"
45580|NCT01935622|O2|Outcome|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
45581|NCT01935622|O1|Outcome|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
45582|NCT01935622|E3|Reported Event|Placebo|"Placebo~placebo"
45583|NCT01935622|E2|Reported Event|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
45584|NCT01935622|E1|Reported Event|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
45585|NCT01934790|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45586|NCT01934790|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45587|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45588|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45589|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45590|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45591|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45592|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45596|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45597|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45598|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45599|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45600|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45601|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45602|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45603|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45604|NCT01934790|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
45605|NCT01934582|B1|Baseline|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.
45606|NCT01934582|P1|Participant Flow|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.
45607|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
45608|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
45609|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
45610|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
45611|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
45612|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
45613|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
45614|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
45615|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
45616|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
45617|NCT01934582|E2|Reported Event|PK Visit 2|UT-15C SR (treprostinil diethanolamine): open-label study drug
45618|NCT01934582|E1|Reported Event|PK Visit 1|UT-15C SR (treprostinil diethanolamine): open-label study drug
45619|NCT01934517|B1|Baseline|iTero, Lava Digital and Plaster Models|All study participants: iTero, LavaDigital and plaster models (single-group study)
45620|NCT01934517|P1|Participant Flow|iTero, Lava Digital and Plaster Models: All Study Participants|"Single-group study:~ITero models obtained from intraoral scans with iTero scanner~Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster~Lava Digital models obtained from extraoral scans of plaster models"
45621|NCT01934517|O3|Outcome|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
45622|NCT01934517|O2|Outcome|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
45623|NCT01934517|O1|Outcome|iTero Models|ITero models obtained from intraoral scans with iTero scanner
45624|NCT01934517|E3|Reported Event|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
45625|NCT01934517|E2|Reported Event|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
45626|NCT01934517|E1|Reported Event|iTero Models|ITero models obtained from intraoral scans with iTero scanner
45627|NCT01934504|B5|Baseline|Total|Total of all reporting groups
45628|NCT01934504|B4|Baseline|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45629|NCT01934504|B3|Baseline|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45630|NCT01934504|B2|Baseline|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45631|NCT01934504|B1|Baseline|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45666|NCT01933880|B2|Baseline|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45902|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45632|NCT01934504|P4|Participant Flow|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45633|NCT01934504|P3|Participant Flow|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45634|NCT01934504|P2|Participant Flow|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45635|NCT01934504|P1|Participant Flow|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45636|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45637|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45638|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45639|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45640|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45641|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45642|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45643|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45644|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45645|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45646|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45647|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45744|NCT01933672|B1|Baseline|All*|A total of 90 participants with T2DM were consented for this study; of these, 43 transitioned into run-in with Sponsor-provided metformin and a total of 33 participants were randomized.
45903|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45648|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45649|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45650|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45651|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45652|NCT01934504|E4|Reported Event|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
45653|NCT01934504|E3|Reported Event|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45654|NCT01934504|E2|Reported Event|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45655|NCT01934504|E1|Reported Event|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
45656|NCT01934231|B1|Baseline|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45657|NCT01934231|P1|Participant Flow|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45658|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45659|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45660|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45661|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45662|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45663|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45664|NCT01934231|E1|Reported Event|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
45665|NCT01933880|B3|Baseline|Total|Total of all reporting groups
49858|NCT01900067|E2|Reported Event|Control|No active warming, standard of care
45667|NCT01933880|B1|Baseline|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45668|NCT01933880|P2|Participant Flow|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45669|NCT01933880|P1|Participant Flow|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45670|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45671|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45672|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
45673|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d).
45674|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
45675|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
45676|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
45677|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
45678|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
45679|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
45680|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
45681|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
45682|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
45683|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
45684|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45685|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45686|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45687|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45688|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45689|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45690|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45691|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45692|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45693|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45694|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45695|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45696|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45697|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45698|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45699|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45700|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45701|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45702|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45703|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45704|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45705|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45706|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45707|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45708|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45709|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45710|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45711|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45712|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45713|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45714|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45715|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45716|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
49859|NCT01900067|E1|Reported Event|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
45717|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45718|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45719|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45720|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45721|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45722|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45723|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45724|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45725|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45726|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45727|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45728|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45729|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45730|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
45731|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45732|NCT01933880|E1|Reported Event|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
45733|NCT01933776|B3|Baseline|Total|Total of all reporting groups
45734|NCT01933776|B2|Baseline|ADACEL™ Vaccine Group 2|Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45735|NCT01933776|B1|Baseline|ADACEL™ Vaccine Group 1|Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45736|NCT01933776|P2|Participant Flow|ADACEL™ Vaccine Group 2 (Children)|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45737|NCT01933776|P1|Participant Flow|ADACEL™ Vaccine Group 1 (Adults)|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45738|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45739|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45740|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45741|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45742|NCT01933776|E2|Reported Event|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
45743|NCT01933776|E1|Reported Event|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
48026|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
45745|NCT01933672|P7|Participant Flow|Sitagliptin Then PF-04937319 300mg Then PF-04937319 150+100mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the third intervention period.
45746|NCT01933672|P6|Participant Flow|Sitagliptin Then PF-04937319 150+100mg Then PF-04937319 300mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
45747|NCT01933672|P5|Participant Flow|PF-04937319 300mg Then Sitagliptin Then PF-04937319 150+100mg|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period.
45748|NCT01933672|P4|Participant Flow|PF-04937319 300mg Then PF-04937319 150+100mg Then Sitagliptin|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days.
45749|NCT01933672|P3|Participant Flow|PF-04937319 150+100mg Then Sitagliptin Then PF-04937319 300mg|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
45750|NCT01933672|P2|Participant Flow|PF-04937319 150+100mg Then PF-04937319 300mg Then Sitagliptin|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
45751|NCT01933672|P1|Participant Flow|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 milligram (mg) immediate-release tablets.
45752|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45753|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45860|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45754|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45755|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45756|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45757|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45758|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45759|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45760|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45761|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45762|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45763|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45764|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45765|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45766|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45767|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45768|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45769|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45770|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45814|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
45771|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45772|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45773|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45774|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45775|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45776|NCT01933672|O4|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45777|NCT01933672|O3|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45778|NCT01933672|O2|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45779|NCT01933672|O1|Outcome|Metformin Run-in|Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day.
45780|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45781|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45782|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45783|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45784|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45785|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45786|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45787|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45788|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45904|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45789|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45790|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45791|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45792|NCT01933672|E4|Reported Event|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45793|NCT01933672|E3|Reported Event|PF-04937319 300 mg (Once Daily)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45794|NCT01933672|E2|Reported Event|PF-04937319 150+100 mg (Split Dose)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
45795|NCT01933672|E1|Reported Event|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 mg immediate-release tablets.
45796|NCT01933425|B1|Baseline|Patient Characteristics in 14 Women|
45797|NCT01933425|P2|Participant Flow|No Neuromuscular Block First Then Deep Neuromuscular Block|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
45798|NCT01933425|P1|Participant Flow|Deep Neuromuscular Block First Then no Neuromuscular Block|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
45799|NCT01933425|O2|Outcome|no Neuromuscular Blockade|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
45800|NCT01933425|O1|Outcome|Deep Neuromuscular Blockade|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
45801|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
45802|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
45803|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
45804|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
45805|NCT01933425|E2|Reported Event|No Neuromuscular Block First Then Deep Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
45806|NCT01933425|E1|Reported Event|Deep Neuromuscular Block First Then no Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
45807|NCT01933399|B4|Baseline|Total|Total of all reporting groups
45808|NCT01933399|B3|Baseline|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
45809|NCT01933399|B2|Baseline|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
45810|NCT01933399|B1|Baseline|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
45811|NCT01933399|P3|Participant Flow|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
45812|NCT01933399|P2|Participant Flow|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
45813|NCT01933399|P1|Participant Flow|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
48027|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
45815|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
45816|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
45817|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
45818|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
45819|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
45820|NCT01933399|E3|Reported Event|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
45821|NCT01933399|E2|Reported Event|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
45822|NCT01933399|E1|Reported Event|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
45823|NCT01933334|B3|Baseline|Total|Total of all reporting groups
45824|NCT01933334|B2|Baseline|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45825|NCT01933334|B1|Baseline|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45826|NCT01933334|P2|Participant Flow|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45827|NCT01933334|P1|Participant Flow|Pirfenidone: 2-Week Titration Group|Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45828|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45829|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45830|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45831|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45832|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45833|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45834|NCT01933334|E2|Reported Event|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
45835|NCT01933334|E1|Reported Event|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
45858|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45859|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45836|NCT01933230|B1|Baseline|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~We will place an Excel Cryo Cooling System collar around your neck for two hours. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
45837|NCT01933230|P1|Participant Flow|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours."
45838|NCT01933230|O1|Outcome|Excel Cryo Cooling System Collar|We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
45839|NCT01933230|E1|Reported Event|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
45840|NCT01932762|B5|Baseline|Total|Total of all reporting groups
45841|NCT01932762|B4|Baseline|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45842|NCT01932762|B3|Baseline|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45843|NCT01932762|B2|Baseline|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45844|NCT01932762|B1|Baseline|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45845|NCT01932762|P4|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45846|NCT01932762|P3|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45847|NCT01932762|P2|Participant Flow|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45848|NCT01932762|P1|Participant Flow|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
45849|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45850|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45851|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45852|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45853|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45854|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45855|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45856|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45857|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
94279|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
45862|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45863|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45864|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45865|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45866|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45867|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45868|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45869|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45870|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45871|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45872|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45873|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45874|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45875|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45876|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45877|NCT01932762|E4|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
45878|NCT01932762|E3|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45879|NCT01932762|E2|Reported Event|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
45880|NCT01932762|E1|Reported Event|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
45881|NCT01932606|B3|Baseline|Total|Total of all reporting groups
45882|NCT01932606|B2|Baseline|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45883|NCT01932606|B1|Baseline|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45884|NCT01932606|P2|Participant Flow|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45885|NCT01932606|P1|Participant Flow|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45886|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45887|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45888|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45889|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45890|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45891|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45892|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45893|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45894|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45895|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45896|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45897|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45898|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45899|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45900|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
49860|NCT01900054|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 12 weeks
45905|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45906|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45907|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45908|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45909|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45910|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45911|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45912|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45913|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45914|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45915|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45916|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45917|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45918|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45919|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45920|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45921|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45922|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45923|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45924|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45925|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45926|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45927|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45928|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45929|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45930|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45931|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45932|NCT01932606|E2|Reported Event|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
45933|NCT01932606|E1|Reported Event|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
45934|NCT01932164|B1|Baseline|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery~maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;~Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
45935|NCT01932164|P1|Participant Flow|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
45936|NCT01932164|O1|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
45937|NCT01932164|E1|Reported Event|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
45938|NCT01932112|B1|Baseline|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
48028|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
45939|NCT01932112|P1|Participant Flow|Adenosine Arm|"After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
45940|NCT01932112|O1|Outcome|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
45941|NCT01932112|E1|Reported Event|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
45942|NCT01932060|B3|Baseline|Total|Total of all reporting groups
45943|NCT01932060|B2|Baseline|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45944|NCT01932060|B1|Baseline|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45945|NCT01932060|P2|Participant Flow|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45946|NCT01932060|P1|Participant Flow|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45947|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45948|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45949|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45950|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45951|NCT01932060|E2|Reported Event|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45952|NCT01932060|E1|Reported Event|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
45953|NCT01931878|B1|Baseline|All Study Participants|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
45954|NCT01931878|P2|Participant Flow|IncobotulinumtoxinA First, Then Placebo|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo."
45955|NCT01931878|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.
45956|NCT01931878|O2|Outcome|IncobotulinumtoxinA Treatment|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
45957|NCT01931878|O1|Outcome|Placebo , Saline|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design.
46246|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
45958|NCT01931878|O2|Outcome|Xeomin|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions."
45959|NCT01931878|O1|Outcome|Placebo|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo."
45960|NCT01931878|O2|Outcome|Xeomin|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
45961|NCT01931878|O1|Outcome|Placebo|In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.
45962|NCT01931878|E2|Reported Event|IncobotulinumtoxinA Treatment|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
45963|NCT01931878|E1|Reported Event|Placebo , Saline|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
45964|NCT01931865|B1|Baseline|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45965|NCT01931865|P1|Participant Flow|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45966|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45967|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45968|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45969|NCT01931865|E1|Reported Event|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
45970|NCT01931527|B3|Baseline|Total|Total of all reporting groups
45971|NCT01931527|B2|Baseline|High Uric Acid|15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid >6mg/dL
45972|NCT01931527|B1|Baseline|Low Uric Acid|16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid <5mg/dL
45973|NCT01931527|P2|Participant Flow|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
45974|NCT01931527|P1|Participant Flow|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
45975|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
45976|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
45977|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
45978|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
45979|NCT01931527|E2|Reported Event|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
45980|NCT01931527|E1|Reported Event|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
45981|NCT01931475|B3|Baseline|Total|Total of all reporting groups
45982|NCT01931475|B2|Baseline|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45983|NCT01931475|B1|Baseline|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45984|NCT01931475|P2|Participant Flow|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45985|NCT01931475|P1|Participant Flow|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45986|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45987|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45988|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45989|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45990|NCT01931475|O1|Outcome|All Participants (60 mg Duloxetine & Placebo)|"Duloxetine:~Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg.~Placebo:~Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase:~1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment."
45991|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
46033|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
45992|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45993|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45994|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45995|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45996|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45997|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
45998|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
45999|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
46000|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
46001|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
46002|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
46003|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
46004|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
46034|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46005|NCT01931475|E6|Reported Event|Placebo Taper|Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
46006|NCT01931475|E5|Reported Event|60 mg Duloxetine Taper|1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
46007|NCT01931475|E4|Reported Event|Placebo/60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
46008|NCT01931475|E3|Reported Event|60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks.
46009|NCT01931475|E2|Reported Event|Placebo Double Blind|Placebo administered by mouth once a day (QD) for 13 weeks.
46010|NCT01931475|E1|Reported Event|60 mg Duloxetine Double Blind|60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
46011|NCT01931150|B3|Baseline|Total|Total of all reporting groups
46012|NCT01931150|B2|Baseline|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46013|NCT01931150|B1|Baseline|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46014|NCT01931150|P2|Participant Flow|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46015|NCT01931150|P1|Participant Flow|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46016|NCT01931150|O2|Outcome|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46017|NCT01931150|O1|Outcome|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46018|NCT01931150|E2|Reported Event|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46019|NCT01931150|E1|Reported Event|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
46020|NCT01930890|B5|Baseline|Total|Total of all reporting groups
46021|NCT01930890|B4|Baseline|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46022|NCT01930890|B3|Baseline|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46023|NCT01930890|B2|Baseline|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46024|NCT01930890|B1|Baseline|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46025|NCT01930890|P4|Participant Flow|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46026|NCT01930890|P3|Participant Flow|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46027|NCT01930890|P2|Participant Flow|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46028|NCT01930890|P1|Participant Flow|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46029|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46030|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46031|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46032|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46241|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46035|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46036|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46037|NCT01930890|E4|Reported Event|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46038|NCT01930890|E3|Reported Event|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46039|NCT01930890|E2|Reported Event|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46040|NCT01930890|E1|Reported Event|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
46041|NCT01930799|B1|Baseline|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
46042|NCT01930799|P1|Participant Flow|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
46043|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
46044|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
46045|NCT01930799|E1|Reported Event|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
46046|NCT01930487|B1|Baseline|Participants Completing Study|Participants who completed both arms of the crossover study
46047|NCT01930487|P2|Participant Flow|Placebo, Then Supplement With Antioxidants|placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
46048|NCT01930487|P1|Participant Flow|Supplement With Antioxidants, Then Placebo|dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
46049|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46050|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46051|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46052|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46053|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46054|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46055|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46056|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46057|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46058|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46059|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46060|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46061|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46062|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46063|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46242|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
94280|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
46064|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46065|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46066|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46067|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46068|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46069|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46070|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46071|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46072|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46073|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46074|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46075|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46076|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46077|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46078|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46079|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46080|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46081|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46082|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46083|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46084|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46085|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46086|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46087|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46088|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46089|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46090|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46091|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46092|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46093|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46243|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46094|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46095|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46096|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46097|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46098|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46099|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46100|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46101|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46102|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46103|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46104|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46105|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46106|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46107|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46108|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46109|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46110|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46111|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46112|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46113|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46114|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46115|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46116|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46117|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46118|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46119|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46120|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46121|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46122|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46123|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46244|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46124|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46125|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46126|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46127|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46128|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46129|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46130|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46131|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46132|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46133|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46134|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46135|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46136|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46137|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
46138|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46139|NCT01930487|E2|Reported Event|Placebo|"placebo supplement~Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants"
46140|NCT01930487|E1|Reported Event|Supplement w/ Antioxidants|"dietary supplement with antioxidants~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
46141|NCT01930435|B1|Baseline|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46142|NCT01930435|P1|Participant Flow|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46143|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46144|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46145|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46146|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor."
46147|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46148|NCT01930435|E1|Reported Event|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
46149|NCT01929031|B5|Baseline|Total|Total of all reporting groups
46150|NCT01929031|B4|Baseline|Ibuprofen/Caffeine Stage 1|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
46151|NCT01929031|B3|Baseline|Ibuprofen Stage 1|One Ibuprofen 400mg tablet after dental surgery
46152|NCT01929031|B2|Baseline|Caffeine Stage 1|One Caffeine 100mg tablet after dental surgery
46153|NCT01929031|B1|Baseline|Placebo Stage 1|One Placebo tablet after dental surgery
46154|NCT01929031|P6|Participant Flow|Placebo - Ibuprofen|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
46155|NCT01929031|P5|Participant Flow|Placebo - Ibuprofen/Caffeine|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
46156|NCT01929031|P4|Participant Flow|Caffeine - Ibuprofen|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
46157|NCT01929031|P3|Participant Flow|Caffeine - Ibuprofen/Caffeine|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
46158|NCT01929031|P2|Participant Flow|Ibuprofen - Ibuprofen|Study stage 1: One Ibuprofen 400mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
46159|NCT01929031|P1|Participant Flow|Ibuprofen/Caffeine - Ibuprofen/Caffeine|Study stage 1: One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen400mg/Caffeine 100mg tablet, while awake, over 5 days
46160|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
46161|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
46162|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
46163|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
46164|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
46165|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
46166|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
46167|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
46168|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
46169|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
46170|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
46171|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
46172|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
46173|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
46174|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
46175|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
46176|NCT01929031|E4|Reported Event|Ibuprofen/Caffeine|Ibuprofen 400mg / Caffeine 100mg tablet
46177|NCT01929031|E3|Reported Event|Ibuprofen|Ibuprofen 400mg tablet
46178|NCT01929031|E2|Reported Event|Caffeine|Caffeine 100mg tablet
46179|NCT01929031|E1|Reported Event|Placebo|Placebo tablet
46180|NCT01928940|B3|Baseline|Total|Total of all reporting groups
46181|NCT01928940|B2|Baseline|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46182|NCT01928940|B1|Baseline|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46183|NCT01928940|P2|Participant Flow|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46184|NCT01928940|P1|Participant Flow|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46185|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46186|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46187|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46188|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46189|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46190|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46191|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46192|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46193|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46194|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46195|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46196|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46197|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46198|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46245|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
94281|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
46199|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46200|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46201|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46202|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46203|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46204|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46205|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46206|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46207|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46208|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
48029|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
46209|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46210|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46211|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46212|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46213|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46214|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46215|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46216|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46217|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46218|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46219|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46220|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46221|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46222|NCT01928940|E2|Reported Event|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46223|NCT01928940|E1|Reported Event|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
46224|NCT01930058|B4|Baseline|Total|Total of all reporting groups
46225|NCT01930058|B3|Baseline|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46226|NCT01930058|B2|Baseline|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46227|NCT01930058|B1|Baseline|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
46228|NCT01930058|P3|Participant Flow|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46229|NCT01930058|P2|Participant Flow|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46230|NCT01930058|P1|Participant Flow|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
46231|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46232|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46233|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
46234|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46235|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46236|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
46237|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46238|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46239|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
46240|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
46247|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
46248|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
46249|NCT01930058|E2|Reported Event|MK-8876 800 mg|All HCV GT1a and GT3 participants treated with MK-8876 800 mg are included.
46250|NCT01930058|E1|Reported Event|MK-8876 150 mg|All HCV GT3 participants treated with MK-8876 150 mg are included.
46251|NCT01930045|B1|Baseline|All Participants|All enrolled participants
46252|NCT01930045|P6|Participant Flow|Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
46253|NCT01930045|P5|Participant Flow|MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
46254|NCT01930045|P4|Participant Flow|Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
46255|NCT01930045|P3|Participant Flow|Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
46256|NCT01930045|P2|Participant Flow|MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
46257|NCT01930045|P1|Participant Flow|Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
46258|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
46259|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
46260|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46261|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
46262|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
46263|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46264|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
46265|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
46266|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46267|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
46268|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
46269|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46270|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
46271|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
46272|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46273|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
46274|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
46275|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
46276|NCT01930045|E5|Reported Event|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
46277|NCT01930045|E4|Reported Event|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
46278|NCT01930045|E3|Reported Event|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
46279|NCT01930045|E2|Reported Event|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
46280|NCT01930045|E1|Reported Event|Raltegravir|400 mg Raltegravir alone
46281|NCT01929993|B3|Baseline|Total|Total of all reporting groups
46282|NCT01929993|B2|Baseline|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
46446|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46283|NCT01929993|B1|Baseline|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
46284|NCT01929993|P2|Participant Flow|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
46285|NCT01929993|P1|Participant Flow|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.
46286|NCT01929993|O2|Outcome|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
46287|NCT01929993|O1|Outcome|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
46288|NCT01929993|E2|Reported Event|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
46289|NCT01929993|E1|Reported Event|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
46290|NCT01929980|B1|Baseline|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
46291|NCT01929980|P1|Participant Flow|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
46292|NCT01929980|O1|Outcome|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
46293|NCT01929980|E1|Reported Event|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
46294|NCT01929889|B1|Baseline|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
46295|NCT01929889|P1|Participant Flow|A Single Arm, Open Label, Exploratory Study|This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
46296|NCT01929889|O1|Outcome|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
46325|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46326|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46559|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46297|NCT01929889|E1|Reported Event|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
46298|NCT01929876|B1|Baseline|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46299|NCT01929876|P1|Participant Flow|Cobimetinib + Itraconazole|Cobimetinib 10 milligram (mg) (two 5 mg capsules) administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46300|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46301|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46302|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46303|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46304|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46305|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46306|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46307|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46308|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46309|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46310|NCT01929876|E1|Reported Event|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
46311|NCT01929473|B1|Baseline|Blood Drawings (0 Day, 365 Day) and Questionnaires|
46312|NCT01929473|P1|Participant Flow|Blood Drawings (0 Day, 365 Day) and Questionnaires|
46313|NCT01929473|O1|Outcome|Blood Drawings (0 Day, 365 Day) and Questionnaires|
46314|NCT01929473|E1|Reported Event|Blood Drawings (0 Day, 365 Day) and Questionnaires|
46315|NCT01929460|B3|Baseline|Total|Total of all reporting groups
46316|NCT01929460|B2|Baseline|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46317|NCT01929460|B1|Baseline|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46318|NCT01929460|P2|Participant Flow|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46319|NCT01929460|P1|Participant Flow|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46320|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46321|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46322|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46323|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46324|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
48030|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
46327|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46328|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46329|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46330|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46331|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46332|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46333|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46334|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46335|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46336|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46337|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46338|NCT01929460|E2|Reported Event|Intervention Group|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
46339|NCT01929460|E1|Reported Event|Drug (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
46340|NCT01929317|B3|Baseline|Total|Total of all reporting groups
46341|NCT01929317|B2|Baseline|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46342|NCT01929317|B1|Baseline|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46343|NCT01929317|P2|Participant Flow|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
46344|NCT01929317|P1|Participant Flow|Ropinirole CR - High Dose Group|Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
46426|NCT01929135|E1|Reported Event|Atorvastatin Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml)."
46427|NCT01929083|B1|Baseline|Entire Study Population|n=15 subjects who completed the study
46345|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46346|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46347|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46348|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46349|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46350|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46351|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46428|NCT01929083|P2|Participant Flow|Placebo First, Then Progesterone|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46429|NCT01929083|P1|Participant Flow|Progesterone First, Then Placebo|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46352|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46353|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46354|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46355|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46356|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46357|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46358|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46430|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46431|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
49861|NCT01900054|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 12 weeks
46359|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46360|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46361|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46362|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46363|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46364|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46365|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46432|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46433|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46560|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46366|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46367|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46368|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46369|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46370|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46371|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46372|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46434|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46435|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46561|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46373|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46374|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46375|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46376|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46377|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46378|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46379|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46436|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46437|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
49862|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
46380|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46381|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46382|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46383|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46384|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46385|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46386|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46438|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46439|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
48031|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
46387|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46388|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46389|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46390|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46391|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46392|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46393|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46440|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46441|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46562|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46394|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46395|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46396|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46397|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46398|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46399|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46400|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46442|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46443|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46563|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46401|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46402|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46403|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46404|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46405|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46406|NCT01929317|E4|Reported Event|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46407|NCT01929317|E3|Reported Event|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46444|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46445|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46564|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46408|NCT01929317|E2|Reported Event|Ropinirole CR - Maintenance Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46409|NCT01929317|E1|Reported Event|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
46410|NCT01929135|B3|Baseline|Total|Total of all reporting groups
46411|NCT01929135|B2|Baseline|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
46412|NCT01929135|B1|Baseline|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
46413|NCT01929135|P2|Participant Flow|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
46414|NCT01929135|P1|Participant Flow|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
46415|NCT01929135|O2|Outcome|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
46416|NCT01929135|O1|Outcome|Atorvastatin Group|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
46417|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
46418|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
46419|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
46420|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
46421|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
46422|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
46423|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
46424|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
46425|NCT01929135|E2|Reported Event|Placebo Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.~Non medicated dentifrice: fluoride dentifrice."
46447|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46448|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46449|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46450|NCT01929083|E2|Reported Event|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
46451|NCT01929083|E1|Reported Event|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
46452|NCT01929044|B3|Baseline|Total|Total of all reporting groups
46453|NCT01929044|B2|Baseline|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46454|NCT01929044|B1|Baseline|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46455|NCT01929044|P2|Participant Flow|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46456|NCT01929044|P1|Participant Flow|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46457|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46458|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46459|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46460|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46461|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46462|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46463|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46464|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46465|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46466|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46467|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46468|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46469|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46470|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46471|NCT01929044|E2|Reported Event|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
46472|NCT01929044|E1|Reported Event|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
46473|NCT01928693|B4|Baseline|Total|Total of all reporting groups
46474|NCT01928693|B3|Baseline|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46565|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46566|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
94282|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
46475|NCT01928693|B2|Baseline|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46476|NCT01928693|B1|Baseline|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46477|NCT01928693|P3|Participant Flow|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46478|NCT01928693|P2|Participant Flow|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46479|NCT01928693|P1|Participant Flow|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46480|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46481|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46482|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46483|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46484|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46485|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46486|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46567|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46568|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46569|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46487|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46488|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46489|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46490|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46491|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46492|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46493|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46494|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46495|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46496|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46497|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46498|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46570|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46571|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46572|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46499|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46500|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46501|NCT01928693|E3|Reported Event|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46502|NCT01928693|E2|Reported Event|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46503|NCT01928693|E1|Reported Event|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
46504|NCT01928680|B1|Baseline|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
46505|NCT01928680|P1|Participant Flow|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
46506|NCT01928680|O1|Outcome|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
46507|NCT01928680|E1|Reported Event|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
46508|NCT01928615|B1|Baseline|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46509|NCT01928615|P1|Participant Flow|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46510|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46573|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46574|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
49863|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
46511|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46512|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46513|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46514|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46515|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46516|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46517|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46518|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46519|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46520|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46575|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46576|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46577|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
49864|NCT01900054|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 12 weeks
46521|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46522|NCT01928615|E1|Reported Event|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
46523|NCT01928472|B5|Baseline|TOTAL|Total of all reporting groups
46524|NCT01928472|B4|Baseline|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46525|NCT01928472|B3|Baseline|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46526|NCT01928472|B2|Baseline|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46527|NCT01928472|B1|Baseline|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46528|NCT01928472|P4|Participant Flow|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46529|NCT01928472|P3|Participant Flow|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46530|NCT01928472|P2|Participant Flow|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46531|NCT01928472|P1|Participant Flow|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46532|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46533|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46534|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46535|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46536|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46537|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46538|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46539|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46540|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46541|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46542|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46543|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46544|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46545|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46546|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46547|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46548|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46549|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46550|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46551|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46552|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46553|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46554|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46555|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46556|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46557|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46558|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46578|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46579|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46580|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46581|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46582|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46583|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46584|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46585|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46586|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46587|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46588|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46589|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46590|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46591|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
46592|NCT01928472|E5|Reported Event|TOTAL|Total of all reporting groups.
46593|NCT01928472|E4|Reported Event|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
46594|NCT01928472|E3|Reported Event|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46595|NCT01928472|E2|Reported Event|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46596|NCT01928472|E1|Reported Event|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
46597|NCT01928381|B1|Baseline|Overall Study|Overall Study - Starting with Part 1
46598|NCT01928381|P7|Participant Flow|Sequence 6|Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
46599|NCT01928381|P6|Participant Flow|Sequence 5|Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
46600|NCT01928381|P5|Participant Flow|Sequence 4|Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
46601|NCT01928381|P4|Participant Flow|Sequence 3|Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
46602|NCT01928381|P3|Participant Flow|Sequence 2|Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
46603|NCT01928381|P2|Participant Flow|Sequence 1|Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
46604|NCT01928381|P1|Participant Flow|Part 1 - Pain Training|Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
46605|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
46606|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
46607|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
46608|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
46609|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
46610|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
46611|NCT01928381|E5|Reported Event|Overall Study|Overall Study: Part 1 and Part 2
46612|NCT01928381|E4|Reported Event|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
46613|NCT01928381|E3|Reported Event|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
46614|NCT01928381|E2|Reported Event|Part 2 - Placebo|Part 2 - placebo crossover periods
46615|NCT01928381|E1|Reported Event|Part 1|Part 1 - Pain training + 1 week of single blind placebo
46616|NCT01928030|B1|Baseline|Hyaluronidase, Recombinant Human|Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
46617|NCT01928030|P3|Participant Flow|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
46618|NCT01928030|P2|Participant Flow|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
46619|NCT01928030|P1|Participant Flow|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
46620|NCT01928030|O3|Outcome|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
46621|NCT01928030|O2|Outcome|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
46622|NCT01928030|O1|Outcome|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
46623|NCT01928030|O1|Outcome|Hyaluronidase, Recombinant Human|"Patients receive recombinant human hyaluronidase SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1-21 (Phase 2) in the absence of disease progression or unacceptable toxicity.~Biomarker analysis and pharmacology study will be performed during study.~recombinant human hyaluronidase: Given SC"
46624|NCT01928030|E1|Reported Event|Hyaluronidase, Recombinant Human|"Patients receive recombinant human hyaluronidase SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1-21 (Phase 2) in the absence of disease progression or unacceptable toxicity.~Biomarker analysis and pharmacology study will be performed during study.~recombinant human hyaluronidase: Given SC"
50512|NCT01895309|B2|Baseline|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
46625|NCT01927757|B1|Baseline|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46626|NCT01927757|P1|Participant Flow|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46627|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46628|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46629|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46630|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46631|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46632|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46633|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46634|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46635|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46636|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46637|NCT01927757|O2|Outcome|Secondary Failure|Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.
46638|NCT01927757|O1|Outcome|Primary Failure|Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.
46639|NCT01927757|O2|Outcome|Absence of Anti-adalimumab Antibodies|Participants with absence of anti-adalimumab antibodies.
46640|NCT01927757|O1|Outcome|Presence of Anti-adalimumab Antibodies|Participants with anti-adalimumab antibodies.
46641|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46642|NCT01927757|E1|Reported Event|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
46643|NCT01927419|B3|Baseline|Total|Total of all reporting groups
46644|NCT01927419|B2|Baseline|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46645|NCT01927419|B1|Baseline|Nivolumab + Ipilimumab|Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46646|NCT01927419|P2|Participant Flow|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46647|NCT01927419|P1|Participant Flow|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46648|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46649|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46650|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46651|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) until documented disease progression, toxicity, withdrawal of consent, or study completion.
46652|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46653|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46654|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46791|NCT01925170|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
46792|NCT01924975|B3|Baseline|Total|Total of all reporting groups
46655|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46656|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46657|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46658|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46659|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46660|NCT01927419|E2|Reported Event|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46661|NCT01927419|E1|Reported Event|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
46662|NCT01927055|B4|Baseline|Total|Total of all reporting groups
46663|NCT01927055|B3|Baseline|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
46664|NCT01927055|B2|Baseline|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
46665|NCT01927055|B1|Baseline|Open-Label|Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
46666|NCT01927055|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
46667|NCT01927055|P2|Participant Flow|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
46668|NCT01927055|P1|Participant Flow|Open-label Titration|"Droxidopa 100 mg, 200 mg~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment"
46669|NCT01927055|O2|Outcome|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
46670|NCT01927055|O1|Outcome|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: Droxidopa at 100 mg, 200 mg, 300 mg"
46671|NCT01927055|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
46672|NCT01927055|E2|Reported Event|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
46673|NCT01927055|E1|Reported Event|Open-label Titration|All patients treated with study drug during dose titration (1-14 days)
46674|NCT01926977|B3|Baseline|Total|Total of all reporting groups
46675|NCT01926977|B2|Baseline|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
46676|NCT01926977|B1|Baseline|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
46677|NCT01926977|P2|Participant Flow|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
46678|NCT01926977|P1|Participant Flow|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
46679|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
46680|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
46681|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
46682|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
46683|NCT01926977|E2|Reported Event|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
46684|NCT01926977|E1|Reported Event|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
46716|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46717|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
51845|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
46685|NCT01926626|B1|Baseline|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46686|NCT01926626|P1|Participant Flow|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46687|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46688|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46689|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46690|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46691|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46692|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46693|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46694|NCT01926626|E1|Reported Event|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
46695|NCT01926015|B3|Baseline|Total|Total of all reporting groups
46696|NCT01926015|B2|Baseline|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46697|NCT01926015|B1|Baseline|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46698|NCT01926015|P2|Participant Flow|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46699|NCT01926015|P1|Participant Flow|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46700|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46701|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46702|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46703|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46704|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46705|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46706|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46707|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46708|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46709|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46710|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46711|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46712|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46713|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46714|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46715|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46718|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46719|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46720|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46721|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46722|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46723|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46724|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46725|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46726|NCT01926015|E2|Reported Event|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46727|NCT01926015|E1|Reported Event|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
46728|NCT01925781|B3|Baseline|Total|Total of all reporting groups
46729|NCT01925781|B2|Baseline|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
46730|NCT01925781|B1|Baseline|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
46731|NCT01925781|P2|Participant Flow|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
46732|NCT01925781|P1|Participant Flow|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
46733|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
46734|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
46735|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
46736|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
46737|NCT01925781|E2|Reported Event|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
46738|NCT01925781|E1|Reported Event|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
46739|NCT01925768|B3|Baseline|Total|Total of all reporting groups
46740|NCT01925768|B2|Baseline|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
46741|NCT01925768|B1|Baseline|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
46742|NCT01925768|P2|Participant Flow|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
46743|NCT01925768|P1|Participant Flow|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
46744|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
46788|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
46789|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
46745|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
46746|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
46747|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
46748|NCT01925768|E2|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast BID during the 24 week placebo controlled period.
46749|NCT01925768|E1|Reported Event|Week 24: Placebo|Participants randomized to receive placebo tablets twice daily (BID) during the placebo-controlled phase. Includes data through week 16 for participants who early escaped and through week 24 for all other participants.
46750|NCT01925703|B1|Baseline|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46751|NCT01925703|P1|Participant Flow|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46752|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46753|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46754|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46755|NCT01925703|E1|Reported Event|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
46756|NCT01925417|B1|Baseline|RBX2660 (Microbiota Suspension)|Open-label; all subjects received RBX2660
46757|NCT01925417|P1|Participant Flow|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46758|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46759|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46760|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46761|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46762|NCT01925417|E1|Reported Event|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
46763|NCT01925183|B3|Baseline|Total|Total of all reporting groups
46764|NCT01925183|B2|Baseline|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46765|NCT01925183|B1|Baseline|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46766|NCT01925183|P2|Participant Flow|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46767|NCT01925183|P1|Participant Flow|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46790|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
46821|NCT01924767|B4|Baseline|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
46768|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46769|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46770|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46771|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46772|NCT01925183|E2|Reported Event|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46773|NCT01925183|E1|Reported Event|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
46774|NCT01925170|B1|Baseline|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
46775|NCT01925170|P1|Participant Flow|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
46776|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
46777|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
46778|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
46779|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
46780|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
46781|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
46782|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
46783|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
46784|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
46785|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
46786|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
46787|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
46793|NCT01924975|B2|Baseline|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
46794|NCT01924975|B1|Baseline|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
46795|NCT01924975|P2|Participant Flow|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
46796|NCT01924975|P1|Participant Flow|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
46797|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
46798|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
46799|NCT01924975|E2|Reported Event|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
46800|NCT01924975|E1|Reported Event|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
46801|NCT01924949|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46802|NCT01924949|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
46803|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46804|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46805|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46806|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46807|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46808|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46809|NCT01924949|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
46810|NCT01924871|B3|Baseline|Total|Total of all reporting groups
46811|NCT01924871|B2|Baseline|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
46812|NCT01924871|B1|Baseline|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
46813|NCT01924871|P2|Participant Flow|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
46814|NCT01924871|P1|Participant Flow|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
46815|NCT01924871|O2|Outcome|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
46816|NCT01924871|O1|Outcome|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
46817|NCT01924871|E2|Reported Event|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
46818|NCT01924871|E1|Reported Event|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
46819|NCT01924767|B6|Baseline|Total|Total of all reporting groups
46820|NCT01924767|B5|Baseline|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
46823|NCT01924767|B2|Baseline|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
46824|NCT01924767|B1|Baseline|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46825|NCT01924767|P5|Participant Flow|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46826|NCT01924767|P4|Participant Flow|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46827|NCT01924767|P3|Participant Flow|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46828|NCT01924767|P2|Participant Flow|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46829|NCT01924767|P1|Participant Flow|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
46830|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46831|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46832|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46833|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46834|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
46835|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46836|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46837|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46838|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46839|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
46840|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46841|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46842|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46843|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46844|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46845|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46846|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46847|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46848|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46849|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46850|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46851|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46852|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46853|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46854|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46855|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46856|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46857|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46858|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46859|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46860|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46861|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46862|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46863|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46864|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46865|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46866|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46867|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46868|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46869|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46870|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46871|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46872|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46873|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46874|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46875|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46876|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46877|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46878|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46879|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46880|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46881|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46882|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46883|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46884|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46885|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46886|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46887|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46888|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46889|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46890|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46891|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46892|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46893|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46894|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46895|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46896|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46897|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46898|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46899|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46900|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46901|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46902|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46903|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46904|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46905|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46906|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46907|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46908|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46909|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46910|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46911|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46912|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46913|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46914|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46915|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46916|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46917|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
51846|NCT01882647|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
46918|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
46919|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
46920|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
46921|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
46922|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46923|NCT01924767|E5|Reported Event|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
46924|NCT01924767|E4|Reported Event|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
46925|NCT01924767|E3|Reported Event|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
46926|NCT01924767|E2|Reported Event|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
46927|NCT01924767|E1|Reported Event|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
46928|NCT01924559|B1|Baseline|SALT and Biohazard Gear|All participants were tested on three intubation devices in either standard clothing or biohazard gear.
46929|NCT01924559|P1|Participant Flow|All Study Participants|All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
46930|NCT01924559|O6|Outcome|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT"
46931|NCT01924559|O5|Outcome|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
46932|NCT01924559|O4|Outcome|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~Glidescope"
46933|NCT01924559|O3|Outcome|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~Glidescope"
46934|NCT01924559|O2|Outcome|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
46935|NCT01924559|O1|Outcome|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
46936|NCT01924559|E6|Reported Event|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT No adverse events"
46937|NCT01924559|E5|Reported Event|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
46938|NCT01924559|E4|Reported Event|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~GlideScope"
46939|NCT01924559|E3|Reported Event|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~GlideScope"
46940|NCT01924559|E2|Reported Event|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
46941|NCT01924559|E1|Reported Event|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
46942|NCT01924390|B3|Baseline|Total|Total of all reporting groups
46943|NCT01924390|B2|Baseline|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46944|NCT01924390|B1|Baseline|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46945|NCT01924390|P2|Participant Flow|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46946|NCT01924390|P1|Participant Flow|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46947|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46948|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46949|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46950|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46951|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46952|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46953|NCT01924390|E2|Reported Event|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
46954|NCT01924390|E1|Reported Event|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
46955|NCT01924182|B3|Baseline|Total|Total of all reporting groups
46956|NCT01924182|B2|Baseline|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
46976|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46957|NCT01924182|B1|Baseline|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
46958|NCT01924182|P2|Participant Flow|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
46959|NCT01924182|P1|Participant Flow|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
46960|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
46961|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
46962|NCT01924182|E2|Reported Event|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
46963|NCT01924182|E1|Reported Event|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
46964|NCT01923896|B3|Baseline|Total|Total of all reporting groups
46965|NCT01923896|B2|Baseline|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46966|NCT01923896|B1|Baseline|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46967|NCT01923896|P2|Participant Flow|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46968|NCT01923896|P1|Participant Flow|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46969|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46970|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46971|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46972|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46973|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46974|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46975|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
47005|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46977|NCT01923896|E2|Reported Event|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
46978|NCT01923896|E1|Reported Event|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
46979|NCT01923467|B1|Baseline|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
46980|NCT01923467|P1|Participant Flow|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
46981|NCT01923467|O1|Outcome|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
46982|NCT01923467|E1|Reported Event|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
46983|NCT01923389|B3|Baseline|Total|Total of all reporting groups
46984|NCT01923389|B2|Baseline|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46985|NCT01923389|B1|Baseline|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46986|NCT01923389|P2|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46987|NCT01923389|P1|Participant Flow|Placebo|Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46988|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46989|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46990|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46991|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46992|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46993|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46994|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46995|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46996|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46997|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46998|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
46999|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47000|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47001|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47002|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47003|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47004|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
94283|NCT01628848|E2|Reported Event|Placebo|Placebo transdermal patch
47006|NCT01923389|E2|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47007|NCT01923389|E1|Reported Event|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
47008|NCT01922349|B5|Baseline|Total|Total of all reporting groups
47009|NCT01922349|B4|Baseline|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47010|NCT01922349|B3|Baseline|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47011|NCT01922349|B2|Baseline|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47012|NCT01922349|B1|Baseline|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47013|NCT01922349|P4|Participant Flow|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47014|NCT01922349|P3|Participant Flow|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47015|NCT01922349|P2|Participant Flow|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47016|NCT01922349|P1|Participant Flow|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
47017|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47018|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47019|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47020|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47021|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47022|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47023|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47024|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47025|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47026|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47027|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47028|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47029|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47030|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47031|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47032|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47033|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47034|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47035|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47036|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47037|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47038|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47039|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47076|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47040|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47041|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47042|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47043|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47044|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47045|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47046|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47047|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47048|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47049|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47050|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47051|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47052|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47053|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47054|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47055|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47056|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 days in Chinese subjects (MRD period)
47057|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47058|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47059|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47060|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47061|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47062|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
47063|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
47064|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
47065|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47066|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47067|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47068|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47069|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47070|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47071|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47072|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47073|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47074|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47075|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
94284|NCT01628848|E1|Reported Event|SPM 962|SPM 962 transdermal patch
47077|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47078|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47079|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47080|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47081|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47082|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47083|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47084|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47085|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47086|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47087|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47088|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47089|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47090|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47091|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47092|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47093|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47094|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47095|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47096|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47097|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47098|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47099|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47100|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47101|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47102|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
47103|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
47104|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
47105|NCT01922349|O4|Outcome|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47106|NCT01922349|O3|Outcome|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47107|NCT01922349|O2|Outcome|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47108|NCT01922349|O1|Outcome|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
47109|NCT01922349|E11|Reported Event|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
47110|NCT01922349|E10|Reported Event|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
47111|NCT01922349|E9|Reported Event|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
47112|NCT01922349|E8|Reported Event|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
47113|NCT01922349|E7|Reported Event|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
47114|NCT01922349|E6|Reported Event|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
51847|NCT01882647|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
47115|NCT01922349|E5|Reported Event|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
47116|NCT01922349|E4|Reported Event|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
47117|NCT01922349|E3|Reported Event|Placebo- Caucasian|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
47118|NCT01922349|E2|Reported Event|Placebo- Japanese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
47119|NCT01922349|E1|Reported Event|Placebo- Chinese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
47120|NCT01922271|B3|Baseline|Total|Total of all reporting groups
47121|NCT01922271|B2|Baseline|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
47122|NCT01922271|B1|Baseline|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
47123|NCT01922271|P2|Participant Flow|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
47124|NCT01922271|P1|Participant Flow|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
47125|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47126|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47127|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47128|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47129|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47130|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47131|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47132|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47133|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47134|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47135|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47136|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47137|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47138|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47139|NCT01922271|E2|Reported Event|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
47140|NCT01922271|E1|Reported Event|NVA237|ALL patients on NVA237 for Period 1 & Period 2
47141|NCT01922115|B3|Baseline|Total|Total of all reporting groups
47142|NCT01922115|B2|Baseline|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47143|NCT01922115|B1|Baseline|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47144|NCT01922115|P2|Participant Flow|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47145|NCT01922115|P1|Participant Flow|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47146|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47147|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47148|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47149|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47150|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47151|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47152|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47207|NCT01921101|B2|Baseline|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
47153|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47154|NCT01922115|E2|Reported Event|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
47155|NCT01922115|E1|Reported Event|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
47156|NCT01922089|B3|Baseline|Total|Total of all reporting groups
47157|NCT01922089|B2|Baseline|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47158|NCT01922089|B1|Baseline|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47159|NCT01922089|P2|Participant Flow|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47160|NCT01922089|P1|Participant Flow|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47161|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47162|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47163|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47164|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47165|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47166|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47167|NCT01922089|E2|Reported Event|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
47168|NCT01922089|E1|Reported Event|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
47169|NCT01920568|B3|Baseline|Total|Total of all reporting groups
47170|NCT01920568|B2|Baseline|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47171|NCT01920568|B1|Baseline|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47172|NCT01920568|P2|Participant Flow|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47173|NCT01920568|P1|Participant Flow|Denosumab 120 mg|Participants received denosumab 120 milligrams (mg) as subcutaneous (SC) injection for a maximum of 13 doses and placebo as intravenous (IV) infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 international unit (IU) of vitamin D.
47174|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47175|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47176|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47177|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47178|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47179|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47180|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47181|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47182|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47183|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
94285|NCT01628692|B7|Baseline|Total|Total of all reporting groups
47184|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47185|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47186|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47187|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47188|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47189|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47190|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47191|NCT01920568|E2|Reported Event|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47192|NCT01920568|E1|Reported Event|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
47193|NCT01921452|B1|Baseline|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
47194|NCT01921452|P1|Participant Flow|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
47195|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
47196|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
47197|NCT01921452|E1|Reported Event|POC TSH Kit + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
47198|NCT01921296|B1|Baseline|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47199|NCT01921296|P1|Participant Flow|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47200|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47201|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47202|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47203|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47204|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47205|NCT01921296|E1|Reported Event|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
47206|NCT01921101|B3|Baseline|Total|Total of all reporting groups
48032|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
47208|NCT01921101|B1|Baseline|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
47209|NCT01921101|P2|Participant Flow|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
47210|NCT01921101|P1|Participant Flow|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
47211|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
47212|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
47213|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
47214|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
47215|NCT01921101|E2|Reported Event|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
47216|NCT01921101|E1|Reported Event|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
47217|NCT01920958|B1|Baseline|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47218|NCT01920958|P1|Participant Flow|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47219|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47220|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47221|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47222|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47223|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47224|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47225|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47226|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47227|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47228|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47229|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47230|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47231|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47232|NCT01920958|E1|Reported Event|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
47233|NCT01920854|B8|Baseline|Total|Total of all reporting groups
47234|NCT01920854|B7|Baseline|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47235|NCT01920854|B6|Baseline|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47401|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
48033|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
47236|NCT01920854|B5|Baseline|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47237|NCT01920854|B4|Baseline|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47238|NCT01920854|B3|Baseline|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47239|NCT01920854|B2|Baseline|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47240|NCT01920854|B1|Baseline|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
47241|NCT01920854|P7|Participant Flow|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47242|NCT01920854|P6|Participant Flow|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47243|NCT01920854|P5|Participant Flow|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47244|NCT01920854|P4|Participant Flow|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47245|NCT01920854|P3|Participant Flow|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47246|NCT01920854|P2|Participant Flow|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47247|NCT01920854|P1|Participant Flow|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
47248|NCT01920854|O7|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47249|NCT01920854|O6|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47250|NCT01920854|O5|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47251|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47252|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47253|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47402|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
99563|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
47254|NCT01920854|O1|Outcome|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
47255|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47256|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47257|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47258|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47259|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47260|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47261|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47262|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47263|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47264|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47265|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47266|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47267|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47268|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47269|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47270|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47271|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47272|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
100249|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
47273|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47274|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47275|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47276|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47277|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47278|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47279|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47280|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47281|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47282|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47283|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47284|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47285|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
47286|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
47287|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47288|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47289|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47290|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47291|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
51848|NCT01882465|B1|Baseline|Overall|All subjects that were enrolled into the study.
47292|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47293|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
47294|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
47295|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47296|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47297|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47298|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47299|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47300|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47301|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47302|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47303|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47304|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47305|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47306|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47307|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47308|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47309|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47310|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
52111|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
47311|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47312|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47313|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
47314|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
47315|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47316|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47317|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47318|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47319|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47320|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47321|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47322|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47323|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47324|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47325|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47326|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47327|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47328|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47329|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
100958|NCT01591616|O3|Outcome|Ventricular Heart Rate, 2 Hour Post-dose|
47330|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47331|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47332|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47333|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47334|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47335|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47336|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47337|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47338|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47339|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47340|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47341|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47342|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47343|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47344|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47345|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47346|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47347|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47348|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
100959|NCT01591616|O2|Outcome|Ventricular Heart Rate, 1 Hour Post-dose|
47349|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47350|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47351|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47352|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47353|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47354|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47355|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47356|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47357|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
47358|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47359|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47360|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47361|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47362|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
47363|NCT01920854|E7|Reported Event|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
47364|NCT01920854|E6|Reported Event|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
47365|NCT01920854|E5|Reported Event|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
47366|NCT01920854|E4|Reported Event|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
47367|NCT01920854|E3|Reported Event|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
47368|NCT01920854|E2|Reported Event|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
47369|NCT01920854|E1|Reported Event|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
47370|NCT01920282|B4|Baseline|Total|Total of all reporting groups
47371|NCT01920282|B3|Baseline|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
47372|NCT01920282|B2|Baseline|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
47373|NCT01920282|B1|Baseline|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
47374|NCT01920282|P3|Participant Flow|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
47375|NCT01920282|P2|Participant Flow|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
47376|NCT01920282|P1|Participant Flow|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
47377|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
47378|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
47379|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
48034|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
47380|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
47381|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
47382|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
47383|NCT01920282|E3|Reported Event|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
47384|NCT01920282|E2|Reported Event|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
47385|NCT01920282|E1|Reported Event|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
47386|NCT01919996|B1|Baseline|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47387|NCT01919996|P1|Participant Flow|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47388|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47389|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47390|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47391|NCT01919996|E1|Reported Event|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
47392|NCT01919801|B3|Baseline|Total|Total of all reporting groups
47393|NCT01919801|B2|Baseline|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47394|NCT01919801|B1|Baseline|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47395|NCT01919801|P2|Participant Flow|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47396|NCT01919801|P1|Participant Flow|Icatibant 30 mg|Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
47397|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47398|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47399|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47400|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
100960|NCT01591616|O1|Outcome|Ventricular Heart Rate, Pre-dose|
47403|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47404|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47405|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47406|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47407|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47408|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47409|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47410|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47411|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47412|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47413|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47414|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47415|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47416|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47417|NCT01919801|E2|Reported Event|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47418|NCT01919801|E1|Reported Event|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
47419|NCT01919606|B3|Baseline|Total|Total of all reporting groups
47420|NCT01919606|B2|Baseline|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47421|NCT01919606|B1|Baseline|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47422|NCT01919606|P2|Participant Flow|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47423|NCT01919606|P1|Participant Flow|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47424|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47425|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47426|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47427|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47428|NCT01919606|E2|Reported Event|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47429|NCT01919606|E1|Reported Event|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
47430|NCT01919229|B4|Baseline|Total|Total of all reporting groups
47431|NCT01919229|B3|Baseline|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47432|NCT01919229|B2|Baseline|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47433|NCT01919229|B1|Baseline|Letrozole|Letrozole 2.5 mg alone once daily
47434|NCT01919229|P3|Participant Flow|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47435|NCT01919229|P2|Participant Flow|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47436|NCT01919229|P1|Participant Flow|Letrozole|Letrozole 2.5 mg alone once daily
47437|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47438|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47439|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47440|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47441|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47442|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47443|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47444|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47445|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47446|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47447|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47448|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47449|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47450|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47451|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47452|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47453|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47454|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47455|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47456|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47457|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47458|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47459|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47460|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
47461|NCT01919229|E3|Reported Event|LEE600mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
47462|NCT01919229|E2|Reported Event|LEE400mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
47463|NCT01919229|E1|Reported Event|Letrozole2.5mgqd|Letrozole 2.5 mg alone once daily
47464|NCT01918371|B3|Baseline|Total|Total of all reporting groups
47465|NCT01918371|B2|Baseline|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47466|NCT01918371|B1|Baseline|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47467|NCT01918371|P2|Participant Flow|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47468|NCT01918371|P1|Participant Flow|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47469|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47470|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47471|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47472|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47473|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47474|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47475|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47476|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47477|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47478|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47479|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47480|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47481|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
102068|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
47482|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47483|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47484|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47485|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47486|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47487|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47488|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47489|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47490|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47491|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47492|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47493|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47494|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47495|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47496|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47497|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47498|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47499|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47500|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47501|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47502|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47503|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47504|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47505|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47506|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47507|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47508|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47654|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47509|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47510|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47511|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47512|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47513|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47514|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47515|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47516|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47517|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47518|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47519|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47520|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47521|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47522|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47523|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47524|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47525|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47526|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47527|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47528|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47529|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47530|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47531|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47532|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47533|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47534|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47535|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47655|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47536|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47537|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47538|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47539|NCT01918371|E2|Reported Event|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47540|NCT01918371|E1|Reported Event|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
47541|NCT01918332|B5|Baseline|Total|Total of all reporting groups
47542|NCT01918332|B4|Baseline|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
47543|NCT01918332|B3|Baseline|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
47544|NCT01918332|B2|Baseline|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
47545|NCT01918332|B1|Baseline|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
47546|NCT01918332|P4|Participant Flow|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
47547|NCT01918332|P3|Participant Flow|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
47548|NCT01918332|P2|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
47549|NCT01918332|P1|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
47550|NCT01918332|O2|Outcome|V160 & Placebo|Valsartan 160mg + Rosuvastatin 20mg placebo & Placebo
47551|NCT01918332|O1|Outcome|V160+R20 & R20|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg placebo + Rosuvastatin 20mg
47552|NCT01918332|O2|Outcome|R20 & Placebo|Valsartan 160mg placebo + Rosuvastatin 20mg & Placebo
47553|NCT01918332|O1|Outcome|V160+R20 & V160|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg + Rosuvastatin 20mg placebo
47554|NCT01918332|E4|Reported Event|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
47555|NCT01918332|E3|Reported Event|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
47556|NCT01918332|E2|Reported Event|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
47557|NCT01918332|E1|Reported Event|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
47558|NCT01918085|B3|Baseline|Total|Total of all reporting groups
47559|NCT01918085|B2|Baseline|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47560|NCT01918085|B1|Baseline|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47561|NCT01918085|P2|Participant Flow|First Peristomal Skin, Then Pre-stripped Abdomianl Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47562|NCT01918085|P1|Participant Flow|First Pre-stripped Abdominal Skin, Then Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47563|NCT01918085|O4|Outcome|Peristomal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
47564|NCT01918085|O3|Outcome|Pre-stripped Abdominal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
47565|NCT01918085|O2|Outcome|Pre-stripped Abdominal Skin -Strata Adhesive|"The peel force used to remove a strata strip from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive"
47566|NCT01918085|O1|Outcome|Peristomal Skin- Strata Adhesive|"The peel force used to remove a strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive"
47567|NCT01918085|E2|Reported Event|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47568|NCT01918085|E1|Reported Event|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
47569|NCT01918033|B4|Baseline|Total|Total of all reporting groups
47570|NCT01918033|B3|Baseline|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47571|NCT01918033|B2|Baseline|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47572|NCT01918033|B1|Baseline|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47573|NCT01918033|P3|Participant Flow|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47574|NCT01918033|P2|Participant Flow|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47575|NCT01918033|P1|Participant Flow|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47576|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47577|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47578|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47579|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47580|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47581|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47582|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47583|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47584|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47585|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47586|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47587|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47588|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47589|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47590|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47591|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47592|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47593|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47594|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47595|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47596|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47597|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47598|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47599|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47600|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47601|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47602|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47603|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47604|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47605|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47606|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47607|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47608|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47609|NCT01918033|E3|Reported Event|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
47610|NCT01918033|E2|Reported Event|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
47611|NCT01918033|E1|Reported Event|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
47612|NCT01917812|B4|Baseline|Total|Total of all reporting groups
47613|NCT01917812|B3|Baseline|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
47656|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47614|NCT01917812|B2|Baseline|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
47615|NCT01917812|B1|Baseline|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
47616|NCT01917812|P3|Participant Flow|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
47617|NCT01917812|P2|Participant Flow|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~No Smart Text Messaging = Group does not receive personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker"
47618|NCT01917812|P1|Participant Flow|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
47619|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
47620|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47621|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47622|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
47623|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47624|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47625|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
47626|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47627|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47628|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47629|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47630|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47631|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47632|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
47633|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
47634|NCT01917812|E3|Reported Event|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
47635|NCT01917812|E2|Reported Event|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
47636|NCT01917812|E1|Reported Event|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
47637|NCT01917773|B1|Baseline|Octreotide|"Fasting motility was recorded for at least 60 minutes.~Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.~Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.~Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded."
47638|NCT01917773|P1|Participant Flow|Octreotide|This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
47639|NCT01917773|O3|Outcome|45 Minutes|The MI for the 45 minutes before and after octreotide infusion was measured.
47640|NCT01917773|O2|Outcome|30 Minutes|The MI for the 30 minutes before and after octreotide infusion was measured.
47641|NCT01917773|O1|Outcome|15 Minutes|The MI for the 15 minutes before and after octreotide infusion was measured.
47642|NCT01917773|E1|Reported Event|All Patients|All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
47643|NCT01917656|B3|Baseline|Total|Total of all reporting groups
47644|NCT01917656|B2|Baseline|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47645|NCT01917656|B1|Baseline|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47646|NCT01917656|P2|Participant Flow|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47647|NCT01917656|P1|Participant Flow|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47648|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47649|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47650|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47651|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47652|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47653|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
48035|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
47657|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47658|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47659|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47660|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47661|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47662|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47663|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47664|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47665|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47666|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47667|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47668|NCT01917656|E2|Reported Event|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
47669|NCT01917656|E1|Reported Event|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
47670|NCT01917526|B3|Baseline|Total|Total of all reporting groups
47671|NCT01917526|B2|Baseline|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
47672|NCT01917526|B1|Baseline|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
47673|NCT01917526|P2|Participant Flow|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
47674|NCT01917526|P1|Participant Flow|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
47675|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
47676|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
47677|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
47678|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
47679|NCT01917526|E2|Reported Event|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
47680|NCT01917526|E1|Reported Event|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
47681|NCT01917344|B1|Baseline|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
47682|NCT01917344|P1|Participant Flow|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
47683|NCT01917344|O1|Outcome|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
47684|NCT01917344|E1|Reported Event|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
47685|NCT01917214|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47686|NCT01917214|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47687|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47688|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47740|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
48036|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
47689|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47690|NCT01917214|O1|Outcome|mRCC Cohort: Sutent Therapy and BSC|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47691|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47692|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47693|NCT01917214|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
47694|NCT01916980|B3|Baseline|Total|Total of all reporting groups
47695|NCT01916980|B2|Baseline|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47696|NCT01916980|B1|Baseline|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47697|NCT01916980|P2|Participant Flow|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47698|NCT01916980|P1|Participant Flow|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47699|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47700|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47701|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47702|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47703|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47704|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47705|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47706|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47707|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47708|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47709|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47710|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47711|NCT01916980|E2|Reported Event|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47712|NCT01916980|E1|Reported Event|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
47713|NCT01916967|B4|Baseline|Total|Total of all reporting groups
47714|NCT01916967|B3|Baseline|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47715|NCT01916967|B2|Baseline|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47716|NCT01916967|B1|Baseline|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47717|NCT01916967|P3|Participant Flow|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47718|NCT01916967|P2|Participant Flow|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47719|NCT01916967|P1|Participant Flow|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47720|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47721|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47722|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47723|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47724|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47725|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47726|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47727|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47728|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47729|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47730|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47731|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47732|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47733|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47734|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47735|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47736|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47737|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47738|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47739|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47741|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47742|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47743|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47744|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
47745|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47746|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47747|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47748|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
47749|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47750|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47751|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47752|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47753|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47754|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47755|NCT01916967|E4|Reported Event|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
47756|NCT01916967|E3|Reported Event|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
47757|NCT01916967|E2|Reported Event|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
47758|NCT01916967|E1|Reported Event|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
47759|NCT01916928|B1|Baseline|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
47760|NCT01916928|P1|Participant Flow|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
47761|NCT01916928|O1|Outcome|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
47762|NCT01916928|E1|Reported Event|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
47763|NCT01916681|B5|Baseline|Total|Total of all reporting groups
47764|NCT01916681|B4|Baseline|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
47765|NCT01916681|B3|Baseline|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47766|NCT01916681|B2|Baseline|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47767|NCT01916681|B1|Baseline|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47768|NCT01916681|P4|Participant Flow|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47769|NCT01916681|P3|Participant Flow|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47770|NCT01916681|P2|Participant Flow|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47771|NCT01916681|P1|Participant Flow|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47772|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47773|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47774|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47775|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47776|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47777|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47778|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47779|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47780|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47781|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47782|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47783|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47784|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47785|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47786|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47787|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47788|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47789|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47790|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47791|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47792|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47793|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47794|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47795|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47796|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47797|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47798|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47799|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47800|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
47801|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47802|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47803|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47804|NCT01916681|E4|Reported Event|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
47805|NCT01916681|E3|Reported Event|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
47806|NCT01916681|E2|Reported Event|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
47831|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47807|NCT01916681|E1|Reported Event|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
47808|NCT01916629|B3|Baseline|Total|Total of all reporting groups
47809|NCT01916629|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
47810|NCT01916629|B1|Baseline|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
47811|NCT01916629|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
47812|NCT01916629|P1|Participant Flow|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
47813|NCT01916629|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
47814|NCT01916629|O1|Outcome|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
47815|NCT01916629|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
47816|NCT01916629|E1|Reported Event|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
47817|NCT01916590|B3|Baseline|Total|Total of all reporting groups
47818|NCT01916590|B2|Baseline|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
47819|NCT01916590|B1|Baseline|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
47820|NCT01916590|P2|Participant Flow|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
47821|NCT01916590|P1|Participant Flow|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
47822|NCT01916590|O2|Outcome|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
47823|NCT01916590|O1|Outcome|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
47824|NCT01916590|E2|Reported Event|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
47825|NCT01916590|E1|Reported Event|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
47826|NCT01916304|B1|Baseline|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47827|NCT01916304|P1|Participant Flow|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47828|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47829|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47830|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
102069|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
47832|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47833|NCT01916304|E1|Reported Event|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
47834|NCT01916226|B5|Baseline|Total|Total of all reporting groups
47835|NCT01916226|B4|Baseline|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47836|NCT01916226|B3|Baseline|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47837|NCT01916226|B2|Baseline|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47838|NCT01916226|B1|Baseline|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47839|NCT01916226|P4|Participant Flow|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47840|NCT01916226|P3|Participant Flow|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47841|NCT01916226|P2|Participant Flow|Cetirizine 10 mg|Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.
47842|NCT01916226|P1|Participant Flow|FPNS 200 μg|Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.
47843|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47844|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47845|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47846|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47847|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47848|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47849|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47850|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47851|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47852|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47853|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47854|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47855|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47856|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47857|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47858|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47859|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47860|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47861|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47862|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47863|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47864|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47865|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47866|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47867|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
47868|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47869|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47870|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks
47871|NCT01916226|E4|Reported Event|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
102070|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
47872|NCT01916226|E3|Reported Event|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
47873|NCT01916226|E2|Reported Event|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
47874|NCT01916226|E1|Reported Event|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
47875|NCT01916109|B1|Baseline|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
47876|NCT01916109|P1|Participant Flow|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
47877|NCT01916109|O1|Outcome|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
47878|NCT01916109|E1|Reported Event|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
47879|NCT01915914|B1|Baseline|Overall|Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47880|NCT01915914|P4|Participant Flow|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47881|NCT01915914|P3|Participant Flow|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
47882|NCT01915914|P2|Participant Flow|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
47883|NCT01915914|P1|Participant Flow|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
47884|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
47885|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47886|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
47887|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
47913|NCT01915849|B2|Baseline|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
48037|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
102071|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
47888|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47889|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
47890|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47891|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
47892|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47893|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47894|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week, up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47895|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
47896|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
47897|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
47898|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
48038|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
47899|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47900|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
47901|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
47902|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47903|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47904|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
47905|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
47906|NCT01915914|E4|Reported Event|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
47907|NCT01915914|E3|Reported Event|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
47908|NCT01915914|E2|Reported Event|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
47909|NCT01915914|E1|Reported Event|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.
47910|NCT01915849|B5|Baseline|Total|Total of all reporting groups
47911|NCT01915849|B4|Baseline|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47912|NCT01915849|B3|Baseline|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47947|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47914|NCT01915849|B1|Baseline|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47915|NCT01915849|P4|Participant Flow|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47916|NCT01915849|P3|Participant Flow|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47917|NCT01915849|P2|Participant Flow|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
47918|NCT01915849|P1|Participant Flow|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
47919|NCT01915849|O4|Outcome|Placebo|All patients who have received placebo once daily for 4 days.
47920|NCT01915849|O3|Outcome|LIK066 150 mg|All patients who have received LIK066 150 mg once daily for 4 days.
47921|NCT01915849|O2|Outcome|LIK066 50 mg|All patients who have received LIK066 50 mg once daily for 4 days.
47922|NCT01915849|O1|Outcome|LIK066 15 mg|All patients who have received LIK066 15 mg once daily for 4 days.
47923|NCT01915849|E4|Reported Event|LIK066 150 mg|LIK066 150 mg
47924|NCT01915849|E3|Reported Event|LIK066 50 mg|LIK066 50 mg
47925|NCT01915849|E2|Reported Event|LIK066 15 mg|LIK066 15 mg
47926|NCT01915849|E1|Reported Event|Placebo|Placebo
47927|NCT01915823|B3|Baseline|Total|Total of all reporting groups
47928|NCT01915823|B2|Baseline|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47929|NCT01915823|B1|Baseline|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47930|NCT01915823|P2|Participant Flow|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47931|NCT01915823|P1|Participant Flow|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47932|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47933|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47934|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47935|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47936|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47937|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47938|NCT01915823|E2|Reported Event|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
47939|NCT01915823|E1|Reported Event|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
47940|NCT01915732|B3|Baseline|Total|Total of all reporting groups
47941|NCT01915732|B2|Baseline|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47942|NCT01915732|B1|Baseline|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47943|NCT01915732|P2|Participant Flow|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47944|NCT01915732|P1|Participant Flow|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47945|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47946|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
48039|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
47948|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47949|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47950|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47951|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47952|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47953|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47954|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47955|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47956|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47957|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47958|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47959|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47960|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47961|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47962|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47963|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47964|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47965|NCT01915732|E2|Reported Event|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
47966|NCT01915732|E1|Reported Event|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
47967|NCT01915108|B5|Baseline|Total|Total of all reporting groups
47968|NCT01915108|B4|Baseline|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47969|NCT01915108|B3|Baseline|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47970|NCT01915108|B2|Baseline|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47971|NCT01915108|B1|Baseline|Group R0|remifentanil Ce of 0 ng/ml
47972|NCT01915108|P4|Participant Flow|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47973|NCT01915108|P3|Participant Flow|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47974|NCT01915108|P2|Participant Flow|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47975|NCT01915108|P1|Participant Flow|Group R0|remifentanil Ce of 0 ng/ml
48022|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48023|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
47976|NCT01915108|O4|Outcome|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47977|NCT01915108|O3|Outcome|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47978|NCT01915108|O2|Outcome|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47979|NCT01915108|O1|Outcome|Group R0|remifentanil Ce of 0 ng/ml
47980|NCT01915108|E4|Reported Event|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47981|NCT01915108|E3|Reported Event|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47982|NCT01915108|E2|Reported Event|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47983|NCT01915108|E1|Reported Event|Group R0|"remifentanil Ce of 0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
47984|NCT01914926|B3|Baseline|Total|Total of all reporting groups
47985|NCT01914926|B2|Baseline|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
47986|NCT01914926|B1|Baseline|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
47987|NCT01914926|P2|Participant Flow|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
47988|NCT01914926|P1|Participant Flow|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
47989|NCT01914926|O2|Outcome|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
47990|NCT01914926|O1|Outcome|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
47991|NCT01914926|E2|Reported Event|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
47992|NCT01914926|E1|Reported Event|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
47993|NCT01914757|B4|Baseline|Total|Total of all reporting groups
47994|NCT01914757|B3|Baseline|Placebo|Placebo administered subcutaneously
47995|NCT01914757|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
47996|NCT01914757|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
47997|NCT01914757|P3|Participant Flow|Placebo|Placebo administered subcutaneously
47998|NCT01914757|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
47999|NCT01914757|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48000|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48001|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48002|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48003|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48004|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48005|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48006|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48007|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48008|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48009|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48010|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48011|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48012|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48013|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48014|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48015|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48016|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48017|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48018|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48019|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48020|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48021|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48040|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48041|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48042|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48043|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48044|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48045|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48046|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48047|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48048|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48049|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48050|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48051|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48052|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48053|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48054|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48055|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48056|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48057|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48058|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48059|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48060|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48061|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48062|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48063|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48064|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48065|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48066|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
48067|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48068|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48069|NCT01914757|E3|Reported Event|Placebo|Placebo administered subcutaneously
48070|NCT01914757|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
48071|NCT01914757|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
48072|NCT01914666|B4|Baseline|Total|Total of all reporting groups
48073|NCT01914666|B3|Baseline|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48074|NCT01914666|B2|Baseline|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48075|NCT01914666|B1|Baseline|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48076|NCT01914666|P3|Participant Flow|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48077|NCT01914666|P2|Participant Flow|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48078|NCT01914666|P1|Participant Flow|Naïve|New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48079|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48080|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48081|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48082|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48083|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48084|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48085|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
102072|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
48086|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48087|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48088|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48089|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48090|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48091|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48092|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48093|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48094|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48095|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48096|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48097|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48098|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48099|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48100|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48101|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48102|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48103|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48104|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48105|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48106|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48107|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48108|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
48109|NCT01914666|E1|Reported Event|Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)|All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
48110|NCT01914003|B3|Baseline|Total|Total of all reporting groups
48111|NCT01914003|B2|Baseline|Control|Individual does not have any known CSID mutations.
48112|NCT01914003|B1|Baseline|CSID Mutations|Individual has one or more known CSID mutations.
48113|NCT01914003|P2|Participant Flow|Control|Individual does not have any known CSID mutations.
48114|NCT01914003|P1|Participant Flow|CSID Mutations|Individual has one or more known CSID mutations.
48115|NCT01914003|O2|Outcome|Control|Individual does not have any known CSID mutations.
48116|NCT01914003|O1|Outcome|CSID Mutations|Individual has one or more known CSID mutations.
48117|NCT01914003|E2|Reported Event|Control|Individual does not have any known CSID mutations.
48118|NCT01914003|E1|Reported Event|CSID Mutations|Individual has one or more known CSID mutations.
48119|NCT01913795|B5|Baseline|Total|Total of all reporting groups
48120|NCT01913795|B4|Baseline|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
48121|NCT01913795|B3|Baseline|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
48122|NCT01913795|B2|Baseline|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
48123|NCT01913795|B1|Baseline|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
48124|NCT01913795|P4|Participant Flow|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
48125|NCT01913795|P3|Participant Flow|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
48126|NCT01913795|P2|Participant Flow|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
48127|NCT01913795|P1|Participant Flow|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
48128|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
48129|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
48130|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
48131|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
48132|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
48133|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
48134|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
48135|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
48136|NCT01913795|E4|Reported Event|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
48137|NCT01913795|E3|Reported Event|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
48138|NCT01913795|E2|Reported Event|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
48139|NCT01913795|E1|Reported Event|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
48140|NCT01913041|B1|Baseline|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
48141|NCT01913041|P1|Participant Flow|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
48142|NCT01913041|O1|Outcome|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
48143|NCT01913041|E1|Reported Event|Observation Group|There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China.
48144|NCT01912781|B3|Baseline|Total|Total of all reporting groups
48145|NCT01912781|B2|Baseline|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48146|NCT01912781|B1|Baseline|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48147|NCT01912781|P2|Participant Flow|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48148|NCT01912781|P1|Participant Flow|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48149|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48150|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48151|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48152|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48153|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48154|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48155|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48156|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48157|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48158|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48159|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48160|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48161|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48162|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48163|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48164|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48165|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48166|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48167|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48168|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48169|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48170|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48171|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48172|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
48173|NCT01912781|E3|Reported Event|Boston Simplus|All subjects who were exposed to Boston Simplus
48174|NCT01912781|E2|Reported Event|FID 120974A|All subjects who were exposed to FID 120947A
48175|NCT01912781|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
48176|NCT01912768|B3|Baseline|Total|Total of all reporting groups
48177|NCT01912768|B2|Baseline|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48178|NCT01912768|B1|Baseline|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48179|NCT01912768|P2|Participant Flow|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48180|NCT01912768|P1|Participant Flow|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48181|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48182|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48183|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48184|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48185|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48186|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48187|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48188|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48189|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48190|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48191|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48192|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48193|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48194|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48195|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48196|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48197|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48198|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48199|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48200|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48201|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48202|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48203|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48204|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
48205|NCT01912768|E3|Reported Event|Renu Fresh|All subjects who were exposed to renu fresh
48206|NCT01912768|E2|Reported Event|FID 120947A|All subjects who were exposed to FID 120947A
48207|NCT01912768|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
48208|NCT01912599|B3|Baseline|Total|Total of all reporting groups
48209|NCT01912599|B2|Baseline|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48210|NCT01912599|B1|Baseline|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48211|NCT01912599|P2|Participant Flow|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48212|NCT01912599|P1|Participant Flow|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48213|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48214|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48215|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48216|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48217|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48218|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48219|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48220|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48221|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48222|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48255|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48256|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48257|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48223|NCT01912599|E2|Reported Event|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48224|NCT01912599|E1|Reported Event|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
48225|NCT01912495|B1|Baseline|Boceprevir/Peginterferon/Ribavirin|Boceprevir with Peginterferon and Ribavirin
48226|NCT01912495|P1|Participant Flow|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
48227|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
48228|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|Boceprevir peginterferon and ribavirin
48229|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|12 week Boceprevir peginterferon and ribavirin
48230|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
48231|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
48232|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
48233|NCT01912495|E1|Reported Event|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
48234|NCT01912404|B3|Baseline|Total|Total of all reporting groups
48235|NCT01912404|B2|Baseline|Placebo|Matching Placebo capsules twice daily for 28 days
48236|NCT01912404|B1|Baseline|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
48237|NCT01912404|P2|Participant Flow|Placebo|Matching Placebo capsules twice daily for 28 days
48238|NCT01912404|P1|Participant Flow|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
48239|NCT01912404|O2|Outcome|Placebo|Matching Placebo capsules twice daily for 28 days
48240|NCT01912404|O1|Outcome|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
48241|NCT01912404|E2|Reported Event|Placebo|Matching Placebo capsules twice daily for 28 days
48242|NCT01912404|E1|Reported Event|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
48243|NCT01912352|B1|Baseline|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
48244|NCT01912352|P1|Participant Flow|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
48245|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
48246|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
48247|NCT01912352|E1|Reported Event|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
48248|NCT01912222|B4|Baseline|Total|Total of all reporting groups
48249|NCT01912222|B3|Baseline|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48250|NCT01912222|B2|Baseline|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48251|NCT01912222|B1|Baseline|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48252|NCT01912222|P3|Participant Flow|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48253|NCT01912222|P2|Participant Flow|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48254|NCT01912222|P1|Participant Flow|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48285|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
48258|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48259|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48260|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48261|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48262|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48263|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48264|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48265|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48266|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48267|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48268|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48269|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
48270|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48271|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48272|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
48273|NCT01912222|E3|Reported Event|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
48274|NCT01912222|E2|Reported Event|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
48275|NCT01912222|E1|Reported Event|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
48276|NCT01911845|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48277|NCT01911845|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48278|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
48279|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
48280|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
48281|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
48282|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
48283|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
48284|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
102073|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
48286|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48287|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48288|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48289|NCT01911845|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
48290|NCT01911780|B3|Baseline|Total|Total of all reporting groups
48291|NCT01911780|B2|Baseline|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48292|NCT01911780|B1|Baseline|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48293|NCT01911780|P2|Participant Flow|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48294|NCT01911780|P1|Participant Flow|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48295|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48296|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48297|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48298|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48299|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48300|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48301|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48302|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48303|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48304|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48305|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48306|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
48346|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
52112|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
48307|NCT01911780|E4|Reported Event|Telmisartan + HCTZ + Placebo - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
48308|NCT01911780|E3|Reported Event|Telmisartan + HCTZ + Amlodipine - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
48309|NCT01911780|E2|Reported Event|Telmisartan + HCTZ + Placebo - Double Blind Period|Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
48310|NCT01911780|E1|Reported Event|Telmisartan + HCTZ + Amlodipine - Double Blind Period|Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
48311|NCT01911689|B3|Baseline|Total|Total of all reporting groups
48312|NCT01911689|B2|Baseline|Controlgroup|All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
48313|NCT01911689|B1|Baseline|Acute Pancreatitis|All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
48314|NCT01911689|P2|Participant Flow|Controlgroup|normal control group：without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).
48315|NCT01911689|P1|Participant Flow|Acute Pancreatitis|acute pancreatitis group：(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.
48316|NCT01911689|O2|Outcome|Severe AP|Severe AP was graded as the Apache II score ≥8 points.
48317|NCT01911689|O1|Outcome|Mild AP|Mild AP was graded as the Apache II score ＜ 7 points.
48318|NCT01911689|O3|Outcome|Severe AP|Severe AP was defined as 7-10 points according to MRSI.
48319|NCT01911689|O2|Outcome|Moderate AP|Moderate AP was defined as 4-6 points according to MRSI.
48320|NCT01911689|O1|Outcome|Mild AP|Mild AP was defined as 0-3 points according to MRSI.
48321|NCT01911689|O2|Outcome|Necrotizing AP|T2* value of necrotizing AP
48322|NCT01911689|O1|Outcome|Edematous AP|T2* value of edematous AP
48323|NCT01911689|O2|Outcome|Control Group|T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders
48324|NCT01911689|O1|Outcome|Acute Pancreatitis|T2* value of AP group is mean T2* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination
48325|NCT01911689|E2|Reported Event|Controlgroup|Not Including Serious
48326|NCT01911689|E1|Reported Event|Acute Pancreatitis|Not Including Serious
48327|NCT01911442|B4|Baseline|Total|Total of all reporting groups
48328|NCT01911442|B3|Baseline|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48329|NCT01911442|B2|Baseline|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48330|NCT01911442|B1|Baseline|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48331|NCT01911442|P3|Participant Flow|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48332|NCT01911442|P2|Participant Flow|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48333|NCT01911442|P1|Participant Flow|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
48334|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
48335|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
48336|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
48337|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
48338|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
48339|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
48340|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48341|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48342|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
48343|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48344|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48345|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
102074|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
48347|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48348|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
48349|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48350|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48351|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48352|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48353|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48354|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
48355|NCT01911442|E3|Reported Event|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
48356|NCT01911442|E2|Reported Event|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
48357|NCT01911442|E1|Reported Event|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
48358|NCT01911403|B3|Baseline|Total|Total of all reporting groups
48359|NCT01911403|B2|Baseline|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48360|NCT01911403|B1|Baseline|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48361|NCT01911403|P2|Participant Flow|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48362|NCT01911403|P1|Participant Flow|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48363|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48364|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48365|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48366|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48367|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48368|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48369|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48370|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48371|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48372|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48373|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48374|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48375|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48376|NCT01911403|E2|Reported Event|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
48377|NCT01911403|E1|Reported Event|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
48378|NCT01911351|B3|Baseline|Total|Total of all reporting groups
48379|NCT01911351|B2|Baseline|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48380|NCT01911351|B1|Baseline|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48381|NCT01911351|P2|Participant Flow|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48382|NCT01911351|P1|Participant Flow|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48383|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48384|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48385|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48386|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48387|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
52113|NCT01880320|E3|Reported Event|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
48388|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48389|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48390|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48391|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48392|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48393|NCT01911351|E2|Reported Event|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
48394|NCT01911351|E1|Reported Event|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
48395|NCT01911273|B3|Baseline|Total|Total of all reporting groups
48396|NCT01911273|B2|Baseline|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48397|NCT01911273|B1|Baseline|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48398|NCT01911273|P2|Participant Flow|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48399|NCT01911273|P1|Participant Flow|PF-03446962 Plus BSC|PF-03446962 7 milligram per kilogram (mg/kg) was administered intravenously (IV) as 1-hour infusion every two weeks (q2w) plus BSC
48400|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48401|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48402|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48403|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48404|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48405|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48406|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48407|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48408|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48409|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48410|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48411|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48412|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48413|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48414|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48415|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48416|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48417|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48418|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48419|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48420|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48421|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
52114|NCT01880320|E2|Reported Event|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
48422|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48423|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48424|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48425|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48426|NCT01911273|E2|Reported Event|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
48427|NCT01911273|E1|Reported Event|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
48428|NCT01911260|B5|Baseline|Total|Total of all reporting groups
48429|NCT01911260|B4|Baseline|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48430|NCT01911260|B3|Baseline|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48431|NCT01911260|B2|Baseline|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48432|NCT01911260|B1|Baseline|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48433|NCT01911260|P4|Participant Flow|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48434|NCT01911260|P3|Participant Flow|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48435|NCT01911260|P2|Participant Flow|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48436|NCT01911260|P1|Participant Flow|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48437|NCT01911260|O4|Outcome|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48438|NCT01911260|O3|Outcome|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48439|NCT01911260|O2|Outcome|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48440|NCT01911260|O1|Outcome|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48441|NCT01911260|E4|Reported Event|Normal Height Receiving Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48442|NCT01911260|E3|Reported Event|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48443|NCT01911260|E2|Reported Event|Growth Deficit Receiving Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48444|NCT01911260|E1|Reported Event|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
48445|NCT01911221|B1|Baseline|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
48446|NCT01911221|P1|Participant Flow|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
48447|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48448|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48449|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48450|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48451|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48452|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48453|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48454|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48455|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48456|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48457|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
48458|NCT01911221|E1|Reported Event|rMenB+OMVNZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
48459|NCT01910831|B1|Baseline|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
48579|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48460|NCT01910831|P1|Participant Flow|DerMend Moisturizing Bruise Formula vs. Vehicle Control|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula vs. Vehicle control."
48461|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
48462|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
48463|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
48464|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
48465|NCT01910831|E1|Reported Event|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
48466|NCT01910688|B1|Baseline|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48467|NCT01910688|P1|Participant Flow|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48468|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48469|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48470|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48501|NCT01910402|P1|Participant Flow|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48471|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48472|NCT01910688|E1|Reported Event|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
48473|NCT01910636|B3|Baseline|Total|Total of all reporting groups
48474|NCT01910636|B2|Baseline|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48475|NCT01910636|B1|Baseline|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48476|NCT01910636|P2|Participant Flow|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48477|NCT01910636|P1|Participant Flow|SOF+RBV Treatment Naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48478|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48479|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48480|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48481|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48482|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48483|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48484|NCT01910636|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
48485|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
48486|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
48487|NCT01910636|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
48488|NCT01910441|B3|Baseline|Total|Total of all reporting groups
48489|NCT01910441|B2|Baseline|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48490|NCT01910441|B1|Baseline|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48491|NCT01910441|P2|Participant Flow|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48492|NCT01910441|P1|Participant Flow|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48493|NCT01910441|O2|Outcome|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48494|NCT01910441|O1|Outcome|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48495|NCT01910441|E2|Reported Event|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48496|NCT01910441|E1|Reported Event|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
48497|NCT01910402|B3|Baseline|Total|Total of all reporting groups
48498|NCT01910402|B2|Baseline|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48499|NCT01910402|B1|Baseline|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48500|NCT01910402|P2|Participant Flow|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48502|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48669|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48503|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48504|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48505|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48506|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48507|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48508|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48509|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48510|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48511|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48512|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48513|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
48514|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48515|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48516|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48517|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48518|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48519|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48520|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48670|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48521|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48522|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48523|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48524|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48525|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
48526|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48527|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48528|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48529|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48530|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48531|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48532|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48533|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48534|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48535|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48536|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48537|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48538|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48671|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48539|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48540|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48541|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48542|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48543|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48544|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48545|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48546|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48547|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48548|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48549|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48550|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48551|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48552|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48553|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48554|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48555|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48556|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48672|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48557|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48558|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48559|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48560|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48561|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48562|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48563|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48564|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48565|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
48566|NCT01910402|E2|Reported Event|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
48567|NCT01910402|E1|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated.
48568|NCT01910389|B3|Baseline|Total|Total of all reporting groups
48569|NCT01910389|B2|Baseline|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48570|NCT01910389|B1|Baseline|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48571|NCT01910389|P2|Participant Flow|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48572|NCT01910389|P1|Participant Flow|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48573|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48574|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48575|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48576|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48577|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48578|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
52115|NCT01880320|E1|Reported Event|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
48580|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48581|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48582|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48583|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48584|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48585|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48586|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48587|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48588|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48589|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48590|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48591|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48592|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48593|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48594|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48595|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48596|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48597|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48598|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48599|NCT01910389|E2|Reported Event|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
48600|NCT01910389|E1|Reported Event|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
48601|NCT01910181|B1|Baseline|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48602|NCT01910181|P1|Participant Flow|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 milligrams (mg) twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The Pharmacokinetic (PK) Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48603|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48620|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48604|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48605|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48606|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48607|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48608|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48609|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48610|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48611|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48612|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48613|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48614|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48615|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48616|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48617|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48618|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48619|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48667|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48668|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
52116|NCT01879852|B3|Baseline|Total|Total of all reporting groups
48621|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48622|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48623|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48624|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
48625|NCT01910181|E1|Reported Event|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
48626|NCT01910116|B3|Baseline|Total|Total of all reporting groups
48627|NCT01910116|B2|Baseline|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48628|NCT01910116|B1|Baseline|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48629|NCT01910116|P2|Participant Flow|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~Placebo"
48630|NCT01910116|P1|Participant Flow|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~Shinbaro"
48631|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48632|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48633|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48634|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48635|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48636|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48637|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48638|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48639|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48640|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48641|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48642|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48643|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48644|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48645|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48646|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48647|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48648|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48649|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48650|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48651|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48652|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48653|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48654|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48655|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48656|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48657|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48658|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48659|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48660|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48661|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48662|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48663|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48664|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48665|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48666|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48673|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48674|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48675|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48676|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48677|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48678|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48679|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48680|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48681|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48682|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48683|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48684|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48685|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48686|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48687|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48688|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48689|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48690|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48691|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48692|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48693|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48694|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48695|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48696|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48697|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48698|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48699|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48700|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48701|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48702|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48703|NCT01910116|E2|Reported Event|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
48704|NCT01910116|E1|Reported Event|Shinbaro|"GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
48705|NCT01910064|B1|Baseline|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48706|NCT01910064|P1|Participant Flow|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48707|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48708|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48709|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48710|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48711|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48712|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
48713|NCT01910064|E1|Reported Event|GK530G|GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
48714|NCT01909804|B13|Baseline|Total|Total of all reporting groups
48715|NCT01909804|B12|Baseline|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48716|NCT01909804|B11|Baseline|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
48717|NCT01909804|B10|Baseline|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48718|NCT01909804|B9|Baseline|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
48719|NCT01909804|B8|Baseline|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48720|NCT01909804|B7|Baseline|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48721|NCT01909804|B6|Baseline|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48722|NCT01909804|B5|Baseline|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48723|NCT01909804|B4|Baseline|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48724|NCT01909804|B3|Baseline|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
48725|NCT01909804|B2|Baseline|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48726|NCT01909804|B1|Baseline|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
48727|NCT01909804|P12|Participant Flow|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48728|NCT01909804|P11|Participant Flow|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
48729|NCT01909804|P10|Participant Flow|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48730|NCT01909804|P9|Participant Flow|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
48731|NCT01909804|P8|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48732|NCT01909804|P7|Participant Flow|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48733|NCT01909804|P6|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48734|NCT01909804|P5|Participant Flow|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48735|NCT01909804|P4|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48736|NCT01909804|P3|Participant Flow|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
48737|NCT01909804|P2|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48738|NCT01909804|P1|Participant Flow|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
48739|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48740|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
48741|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48742|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
48743|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48744|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48745|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48746|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48747|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48748|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
48749|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48750|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
48751|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48752|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
48753|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48754|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
48755|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48756|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48757|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48758|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48759|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48760|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
48761|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48762|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
48763|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
48764|NCT01909804|O3|Outcome|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
48765|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
48766|NCT01909804|O1|Outcome|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
48767|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48768|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
48769|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
48770|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
48771|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48772|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48773|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
48774|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
48775|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48776|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
48777|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
48778|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
48779|NCT01909804|E4|Reported Event|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
48780|NCT01909804|E3|Reported Event|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
48781|NCT01909804|E2|Reported Event|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
48782|NCT01909804|E1|Reported Event|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
48783|NCT01909778|B1|Baseline|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.~A number of 12 entered patients with compensated liver cirrhosis was planned."
48784|NCT01909778|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.~A number of 12 entered patients with compensated liver cirrhosis was planned."
48785|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48786|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48787|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48788|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48789|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48790|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48791|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48792|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48793|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48794|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48795|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48796|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48797|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48798|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48799|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48800|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48801|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48802|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48803|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48804|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48805|NCT01909778|E2|Reported Event|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
48806|NCT01909778|E1|Reported Event|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
48807|NCT01909713|B1|Baseline|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
48808|NCT01909713|P1|Participant Flow|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
48809|NCT01909713|O6|Outcome|I Liked the Lotion Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
48810|NCT01909713|O5|Outcome|I Would Keep Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
48811|NCT01909713|O4|Outcome|The Lotion Made my Skin Feel Soft|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
48812|NCT01909713|O3|Outcome|The Lotion Spread Easily on my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
48813|NCT01909713|O2|Outcome|The Lotion Smelled Good|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
48814|NCT01909713|O1|Outcome|I Liked Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
48815|NCT01909713|O6|Outcome|I Liked the Face Wash Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
48816|NCT01909713|O5|Outcome|I Would Keep Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
48817|NCT01909713|O4|Outcome|The Face Wash Rinsed Easily Off my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
48818|NCT01909713|O3|Outcome|The Face Wash Made my Skin Feel Clean|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
48819|NCT01909713|O2|Outcome|The Face Wash Was Easy to Use|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
48820|NCT01909713|O1|Outcome|I Liked Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
48821|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
48822|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
48823|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
48824|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
48825|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
49333|NCT01905553|E2|Reported Event|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
48826|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
48827|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48828|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48829|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48830|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48831|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48832|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48833|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48834|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48835|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48836|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48837|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48838|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48839|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48840|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48841|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48842|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48843|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48844|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48845|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48846|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48847|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48848|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48849|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48850|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48851|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48852|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48853|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48854|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48855|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
48856|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
48857|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
48858|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
48859|NCT01909713|E1|Reported Event|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
48860|NCT01909570|B3|Baseline|Total|Total of all reporting groups
48861|NCT01909570|B2|Baseline|Double Embryo Transfer|Transfer of two fresh embryos
48862|NCT01909570|B1|Baseline|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48863|NCT01909570|P2|Participant Flow|Double Embryo Transfer|Transfer of two fresh embryos
48864|NCT01909570|P1|Participant Flow|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48865|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
48866|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48867|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
48868|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48869|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
48870|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48871|NCT01909570|E2|Reported Event|Double Embryo Transfer|Transfer of two fresh embryos
48872|NCT01909570|E1|Reported Event|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
48873|NCT01909466|B1|Baseline|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48874|NCT01909466|P2|Participant Flow|Deltoid/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48875|NCT01909466|P1|Participant Flow|Gluteal/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48876|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48877|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48878|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48879|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48880|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
49334|NCT01905553|E1|Reported Event|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
48881|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48882|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48883|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48884|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48885|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48886|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48887|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48888|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48889|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48890|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48891|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48892|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48893|NCT01909466|E1|Reported Event|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
48894|NCT01909336|B4|Baseline|Total|Total of all reporting groups
48895|NCT01909336|B3|Baseline|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|"Group 3: 0.9% Saline in 5% dextrose (intravenous)~0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose"
48896|NCT01909336|B2|Baseline|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|"Group 2: 0.45% Saline in 5% dextrose (intravenous)~0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose"
48897|NCT01909336|B1|Baseline|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|"Group 1: 0.3% Saline in 3.3% dextrose (intravenous)~0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose"
48898|NCT01909336|P3|Participant Flow|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
48899|NCT01909336|P2|Participant Flow|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
48900|NCT01909336|P1|Participant Flow|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
48901|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
48902|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
48903|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
48904|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
48905|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
48906|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
48907|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
48908|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
48909|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
48910|NCT01909336|E3|Reported Event|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
48911|NCT01909336|E2|Reported Event|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
48912|NCT01909336|E1|Reported Event|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
48913|NCT01909180|B1|Baseline|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
48914|NCT01909180|P1|Participant Flow|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
48915|NCT01909180|O3|Outcome|Neuro|Subjects receiving Revolution CT Scans of Brain or Spinal Cord
48916|NCT01909180|O2|Outcome|Body/ Extremity|Subject receiving a Revolution CT scan of the body or extremities
48917|NCT01909180|O1|Outcome|Cardiac|Subjects who received a cardiac CT scan
48918|NCT01909180|E1|Reported Event|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
48919|NCT01909141|B3|Baseline|Total|Total of all reporting groups
48920|NCT01909141|B2|Baseline|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 will received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48921|NCT01909141|B1|Baseline|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48922|NCT01909141|P2|Participant Flow|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48923|NCT01909141|P1|Participant Flow|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48924|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48925|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48926|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48957|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48958|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
49335|NCT01905540|B5|Baseline|Total|Total of all reporting groups
48927|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48928|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48929|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48930|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48931|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48932|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48933|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 receivde letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was be done for arm 1 for 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was caculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48959|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48960|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
49378|NCT01904773|O2|Outcome|AZD5213 2.0 mg|Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
48934|NCT01909141|E2|Reported Event|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48935|NCT01909141|E1|Reported Event|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
48936|NCT01909011|B3|Baseline|Total|Total of all reporting groups
48937|NCT01909011|B2|Baseline|Sham CES|"The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
48938|NCT01909011|B1|Baseline|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
48939|NCT01909011|P2|Participant Flow|Sham CES|"The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
48940|NCT01909011|P1|Participant Flow|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
48941|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
48942|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
48943|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
48944|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
48945|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
48946|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
48947|NCT01909011|E2|Reported Event|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
48948|NCT01909011|E1|Reported Event|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
48949|NCT01908842|B3|Baseline|Total|Total of all reporting groups
48950|NCT01908842|B2|Baseline|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
48951|NCT01908842|B1|Baseline|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
48952|NCT01908842|P2|Participant Flow|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48953|NCT01908842|P1|Participant Flow|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48954|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48955|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48956|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
49076|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
48961|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48962|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48963|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48964|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48965|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48966|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48967|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48968|NCT01908842|E2|Reported Event|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
48969|NCT01908842|E1|Reported Event|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
48970|NCT01908803|B3|Baseline|Total|Total of all reporting groups
48971|NCT01908803|B2|Baseline|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
48972|NCT01908803|B1|Baseline|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
48973|NCT01908803|P2|Participant Flow|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
48974|NCT01908803|P1|Participant Flow|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
48975|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
48976|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
48977|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
48978|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
48979|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
48980|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
48981|NCT01908803|E3|Reported Event|CIPRODEX|Includes all subjects administered a dose of CIPRODEX®
48982|NCT01908803|E2|Reported Event|AL-60371/AL-817|Includes all subjects administered a dose of AL-60371/AL-817
48983|NCT01908803|E1|Reported Event|Pre-treatment|Includes all subjects prior to administration of study medication
48984|NCT01908140|B3|Baseline|Total|Total of all reporting groups
48985|NCT01908140|B2|Baseline|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
48986|NCT01908140|B1|Baseline|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
48987|NCT01908140|P2|Participant Flow|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
48988|NCT01908140|P1|Participant Flow|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
48989|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
48990|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
48991|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
48992|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
48993|NCT01908140|E2|Reported Event|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
48994|NCT01908140|E1|Reported Event|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
48995|NCT01908127|B3|Baseline|Total|Total of all reporting groups
49077|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49078|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49079|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49080|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49081|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
48996|NCT01908127|B2|Baseline|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
48997|NCT01908127|B1|Baseline|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
48998|NCT01908127|P2|Participant Flow|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
48999|NCT01908127|P1|Participant Flow|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49000|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49001|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49002|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49003|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49004|NCT01908127|E2|Reported Event|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49005|NCT01908127|E1|Reported Event|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
49006|NCT01907906|B3|Baseline|Total|Total of all reporting groups
49007|NCT01907906|B2|Baseline|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)
49008|NCT01907906|B1|Baseline|Arm 1: Mirasol-treated WB Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
49009|NCT01907906|P2|Participant Flow|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
49082|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49083|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49084|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49085|NCT01907906|E2|Reported Event|Untreated Control|LR-pRBCs derived from untreated WB
49086|NCT01907906|E1|Reported Event|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB.
49010|NCT01907906|P1|Participant Flow|Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (LR-pRBCs) manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
49011|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49012|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49013|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49014|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49015|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49016|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49017|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49018|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49019|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49020|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49021|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49022|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49023|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49024|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49025|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49026|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49027|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49028|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49029|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49030|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49031|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49032|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49033|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49034|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49035|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49036|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49037|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49038|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49039|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49040|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49041|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49042|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49043|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49044|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49045|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49046|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49047|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49048|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49049|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49050|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49051|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49052|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49053|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49054|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49055|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49056|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49057|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49058|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49059|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49060|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49061|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49062|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49063|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49064|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49065|NCT01907906|O2|Outcome|Untreated Control|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB
49066|NCT01907906|O1|Outcome|Mirasol Treated|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB
49067|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49068|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49069|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49070|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49071|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49072|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49073|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49074|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
49075|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
49087|NCT01907854|B3|Baseline|Total|Total of all reporting groups
49088|NCT01907854|B2|Baseline|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49089|NCT01907854|B1|Baseline|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49090|NCT01907854|P2|Participant Flow|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49091|NCT01907854|P1|Participant Flow|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49092|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49093|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49094|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49095|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49096|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49097|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49098|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49099|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49100|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49101|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49102|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49103|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49104|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49105|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49106|NCT01907854|E2|Reported Event|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
49107|NCT01907854|E1|Reported Event|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
49108|NCT01907516|B3|Baseline|Total|Total of all reporting groups
49109|NCT01907516|B2|Baseline|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
49110|NCT01907516|B1|Baseline|Cell Phone-internet First, the Voicemail|Cell phone-internet home glucose reporting system first
49111|NCT01907516|P2|Participant Flow|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first, then cell phone-internet
49112|NCT01907516|P1|Participant Flow|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first, then voicemail
49113|NCT01907516|O1|Outcome|Total Study Population|All study participants, includes those in cell phone-internet first, then voicemail and voicemail first, then cell phone-internet
49114|NCT01907516|O2|Outcome|Used Voicemail Method|Voicemail first, then cell phone-internet home glucose monitoring system
49115|NCT01907516|O1|Outcome|Used Confidant Method|Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting
49116|NCT01907516|E2|Reported Event|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
49117|NCT01907516|E1|Reported Event|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first
49118|NCT01907490|B1|Baseline|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
49119|NCT01907490|P1|Participant Flow|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
49120|NCT01907490|O1|Outcome|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
49121|NCT01907490|E1|Reported Event|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
49122|NCT01907334|B1|Baseline|All Participants|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
49123|NCT01907334|P2|Participant Flow|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
49124|NCT01907334|P1|Participant Flow|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
49125|NCT01907334|O1|Outcome|Increase in Airway Resistance After Methacholine|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
49126|NCT01907334|E2|Reported Event|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
49127|NCT01907334|E1|Reported Event|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
49128|NCT01907321|B1|Baseline|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
49145|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49459|NCT01904149|B7|Baseline|Total|Total of all reporting groups
49129|NCT01907321|P1|Participant Flow|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, enabling airflow.~Measures performed on all subjects: Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system."
49130|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
49131|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
49132|NCT01907321|E1|Reported Event|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
49133|NCT01907113|B6|Baseline|Total|Total of all reporting groups
49134|NCT01907113|B5|Baseline|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49135|NCT01907113|B4|Baseline|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49136|NCT01907113|B3|Baseline|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49137|NCT01907113|B2|Baseline|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49138|NCT01907113|B1|Baseline|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49139|NCT01907113|P5|Participant Flow|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49140|NCT01907113|P4|Participant Flow|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49141|NCT01907113|P3|Participant Flow|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49142|NCT01907113|P2|Participant Flow|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49143|NCT01907113|P1|Participant Flow|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49144|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49248|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49146|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49147|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49148|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49149|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49150|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49151|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49152|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49153|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49154|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49155|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49156|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49157|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49158|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49159|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49160|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49161|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49162|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49163|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49164|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49165|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49166|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49167|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49168|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49169|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49170|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49292|NCT01905956|E2|Reported Event|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49171|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49172|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49173|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49174|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49175|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49176|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49177|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49178|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49179|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49180|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49181|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49182|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49183|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49184|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49185|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49186|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49187|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49188|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49189|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49190|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49191|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49192|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49193|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49194|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49195|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49293|NCT01905956|E1|Reported Event|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49196|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49197|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49198|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49199|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49200|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49201|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49202|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49203|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49204|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49205|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49206|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49207|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49208|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49209|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49210|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49211|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49212|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49213|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49214|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49215|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49216|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49217|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49218|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49219|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49220|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49294|NCT01905657|B4|Baseline|Total|Total of all reporting groups
49221|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49222|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49223|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49224|NCT01907113|E5|Reported Event|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
49225|NCT01907113|E4|Reported Event|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49226|NCT01907113|E3|Reported Event|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49227|NCT01907113|E2|Reported Event|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49228|NCT01907113|E1|Reported Event|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
49229|NCT01906658|B5|Baseline|Total|Total of all reporting groups
49230|NCT01906658|B4|Baseline|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49231|NCT01906658|B3|Baseline|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49232|NCT01906658|B2|Baseline|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49233|NCT01906658|B1|Baseline|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49234|NCT01906658|P4|Participant Flow|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49235|NCT01906658|P3|Participant Flow|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49236|NCT01906658|P2|Participant Flow|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49237|NCT01906658|P1|Participant Flow|Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49238|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49239|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49240|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49241|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49242|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49243|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49244|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49245|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49246|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49247|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49332|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
102075|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
49249|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49250|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49251|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49252|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49253|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49254|NCT01906658|E4|Reported Event|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49255|NCT01906658|E3|Reported Event|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49256|NCT01906658|E2|Reported Event|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49257|NCT01906658|E1|Reported Event|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
49258|NCT01906515|B3|Baseline|Total|Total of all reporting groups
49259|NCT01906515|B2|Baseline|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
49260|NCT01906515|B1|Baseline|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
49261|NCT01906515|P2|Participant Flow|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
49262|NCT01906515|P1|Participant Flow|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
49263|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
49264|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm.~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
49265|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
49266|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
49267|NCT01906515|E2|Reported Event|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
49268|NCT01906515|E1|Reported Event|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
49269|NCT01905956|B3|Baseline|Total|Total of all reporting groups
49270|NCT01905956|B2|Baseline|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49271|NCT01905956|B1|Baseline|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49272|NCT01905956|P2|Participant Flow|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49273|NCT01905956|P1|Participant Flow|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49274|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49275|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49276|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49277|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49278|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49279|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49280|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49281|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49282|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49283|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49284|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49285|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49286|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49287|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49288|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49289|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49290|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
49291|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
49295|NCT01905657|B3|Baseline|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49296|NCT01905657|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49297|NCT01905657|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49298|NCT01905657|P3|Participant Flow|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49299|NCT01905657|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49300|NCT01905657|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years.
49301|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49302|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49303|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49304|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49305|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49306|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49307|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49308|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49309|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49310|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49311|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49312|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49313|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49314|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49315|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49316|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49317|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49318|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49319|NCT01905657|E3|Reported Event|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
49320|NCT01905657|E2|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
49321|NCT01905657|E1|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
49322|NCT01905553|B3|Baseline|Total|Total of all reporting groups
49323|NCT01905553|B2|Baseline|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
49324|NCT01905553|B1|Baseline|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
49325|NCT01905553|P2|Participant Flow|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
49326|NCT01905553|P1|Participant Flow|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
49327|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
49328|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
49329|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
49330|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
49331|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
49336|NCT01905540|B4|Baseline|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
49337|NCT01905540|B3|Baseline|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
49338|NCT01905540|B2|Baseline|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
49339|NCT01905540|B1|Baseline|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
49340|NCT01905540|P4|Participant Flow|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
49341|NCT01905540|P3|Participant Flow|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
49342|NCT01905540|P2|Participant Flow|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
49343|NCT01905540|P1|Participant Flow|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
49344|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
49345|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
49346|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
49347|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
49348|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
49349|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
49350|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
49351|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
49352|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
49353|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
49354|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
49355|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
49356|NCT01905540|E4|Reported Event|SSP-004184SS (2 Doses)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
49357|NCT01905540|E3|Reported Event|SSP-004184AQ (2 Doses)|SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
49358|NCT01905540|E2|Reported Event|SSP-004184SS (Single Dose)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
49359|NCT01905540|E1|Reported Event|SSP-004184AQ (Single Dose)|SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
49360|NCT01905254|B1|Baseline|Single Arm Study|Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
49361|NCT01905254|P1|Participant Flow|Transient Elastography and Liver Biopsy|"Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa).~Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA).~Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %).~Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in."
49362|NCT01905254|O1|Outcome|Transient Elastography in Autoimmune Hepatitis|Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
49363|NCT01905254|E1|Reported Event|TE in Autoimmune Hepatitis|"Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.~There were no adverse events."
49364|NCT01904773|B1|Baseline|Overall Study|Part 1 & Part 2
49365|NCT01904773|P9|Participant Flow|Part 2- Seqence CBABCA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49366|NCT01904773|P8|Participant Flow|Part 2 Sequence CABBAC|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49367|NCT01904773|P7|Participant Flow|Part 2- Sequence BCACBA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49368|NCT01904773|P6|Participant Flow|Part 2- Sequence BACCAB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49369|NCT01904773|P5|Participant Flow|Part 2- Sequence ACBABC|A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49370|NCT01904773|P4|Participant Flow|Part 2 - Sequence ABCACB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
49371|NCT01904773|P3|Participant Flow|Part 2- Sequence BABBAB|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
49372|NCT01904773|P2|Participant Flow|Part 2 -Sequence BBABBA|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
49373|NCT01904773|P1|Participant Flow|Initial Study|Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
49374|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
49375|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
49376|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
49377|NCT01904773|O3|Outcome|Placebo|Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
102076|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
49379|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
49380|NCT01904773|E7|Reported Event|Part 1 - Placebo|Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
49381|NCT01904773|E6|Reported Event|Part 2 - Placebo|Part 2 - Placebo periods (2 periods)
49382|NCT01904773|E5|Reported Event|Part 2 - AZD5213 2.0 mg|Part 2 - AZD5213, 2.0 mg periods (2 periods)
49383|NCT01904773|E4|Reported Event|Part 2 - AZD5213 0.5 mg|Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
49384|NCT01904773|E3|Reported Event|Part 1 - AZD5213 2.0 mg|Part 1 - Days 6-8, AZD5213 2.0 mg
49385|NCT01904773|E2|Reported Event|Part 1 - AZD5213 0.5 mg|Part 1 - Day 1, AZD5213 0.5 mg
49386|NCT01904773|E1|Reported Event|Overall Study|Part 1 & Part 2
49387|NCT01904760|B3|Baseline|Total|Total of all reporting groups
49388|NCT01904760|B2|Baseline|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
49389|NCT01904760|B1|Baseline|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
49390|NCT01904760|P2|Participant Flow|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
49391|NCT01904760|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
49392|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
49393|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
49394|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
49395|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
49396|NCT01904760|E2|Reported Event|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
49397|NCT01904760|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
49398|NCT01904721|B8|Baseline|Total|Total of all reporting groups
49399|NCT01904721|B7|Baseline|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49400|NCT01904721|B6|Baseline|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49401|NCT01904721|B5|Baseline|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49402|NCT01904721|B4|Baseline|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49403|NCT01904721|B3|Baseline|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49404|NCT01904721|B2|Baseline|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49405|NCT01904721|B1|Baseline|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49406|NCT01904721|P7|Participant Flow|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49407|NCT01904721|P6|Participant Flow|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49408|NCT01904721|P5|Participant Flow|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49409|NCT01904721|P4|Participant Flow|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49410|NCT01904721|P3|Participant Flow|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49411|NCT01904721|P2|Participant Flow|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49412|NCT01904721|P1|Participant Flow|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49413|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49414|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49415|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49416|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49417|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49418|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49419|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49420|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49421|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49422|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49423|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49424|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49425|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49426|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49427|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49428|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49429|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49430|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49431|NCT01904721|E7|Reported Event|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49432|NCT01904721|E6|Reported Event|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49433|NCT01904721|E5|Reported Event|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
49434|NCT01904721|E4|Reported Event|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49435|NCT01904721|E3|Reported Event|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49436|NCT01904721|E2|Reported Event|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
49437|NCT01904721|E1|Reported Event|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
49438|NCT01904604|B4|Baseline|Total|Total of all reporting groups
49439|NCT01904604|B3|Baseline|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49440|NCT01904604|B2|Baseline|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49460|NCT01904149|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
49461|NCT01904149|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
49462|NCT01904149|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
49441|NCT01904604|B1|Baseline|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49442|NCT01904604|P3|Participant Flow|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49443|NCT01904604|P2|Participant Flow|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49444|NCT01904604|P1|Participant Flow|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49445|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49446|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49447|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49448|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49449|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49450|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49451|NCT01904604|O2|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49452|NCT01904604|O1|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49453|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49454|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49455|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49456|NCT01904604|E3|Reported Event|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49457|NCT01904604|E2|Reported Event|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
49458|NCT01904604|E1|Reported Event|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
49463|NCT01904149|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
49464|NCT01904149|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
49465|NCT01904149|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
49466|NCT01904149|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
49467|NCT01904149|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
49468|NCT01904149|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
49469|NCT01904149|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
49470|NCT01904149|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
49471|NCT01904149|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
49472|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49473|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49474|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49475|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49476|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49477|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
49478|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
49479|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
49480|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
49481|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
49482|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
49483|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
49484|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
49485|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
49486|NCT01904149|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
49487|NCT01904149|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
49488|NCT01904149|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
49489|NCT01904149|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
49490|NCT01904149|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
49491|NCT01904149|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
49492|NCT01904071|B4|Baseline|Total|Total of all reporting groups
49493|NCT01904071|B3|Baseline|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49494|NCT01904071|B2|Baseline|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49495|NCT01904071|B1|Baseline|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49496|NCT01904071|P3|Participant Flow|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49497|NCT01904071|P2|Participant Flow|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49498|NCT01904071|P1|Participant Flow|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49585|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49499|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49500|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49501|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49502|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49503|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49504|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49505|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49506|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49507|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49508|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49509|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49510|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49511|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49512|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49513|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49514|NCT01904071|E3|Reported Event|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
49515|NCT01904071|E2|Reported Event|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
49516|NCT01904071|E1|Reported Event|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
49517|NCT01904058|B5|Baseline|Total|Total of all reporting groups
49518|NCT01904058|B4|Baseline|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49519|NCT01904058|B3|Baseline|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49586|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49520|NCT01904058|B2|Baseline|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49521|NCT01904058|B1|Baseline|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49522|NCT01904058|P4|Participant Flow|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49523|NCT01904058|P3|Participant Flow|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49524|NCT01904058|P2|Participant Flow|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49525|NCT01904058|P1|Participant Flow|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49526|NCT01904058|O4|Outcome|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
49527|NCT01904058|O3|Outcome|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
49528|NCT01904058|O2|Outcome|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
49529|NCT01904058|O1|Outcome|LUM001 5 mg + UDCA|Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.
49530|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49531|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49532|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49533|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49534|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49535|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49536|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49537|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49538|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49539|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49540|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49587|NCT01903720|E1|Reported Event|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49588|NCT01903460|B5|Baseline|Total|Total of all reporting groups
49541|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49542|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49543|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49544|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49545|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49546|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49547|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49548|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49549|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49550|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49551|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49552|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49553|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49554|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49555|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49556|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49557|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
49558|NCT01904058|E4|Reported Event|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
49559|NCT01904058|E3|Reported Event|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
49560|NCT01904058|E2|Reported Event|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
49561|NCT01904058|E1|Reported Event|LUM001 5 mg + UDCA|Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
49562|NCT01903876|B3|Baseline|Total|Total of all reporting groups
49589|NCT01903460|B4|Baseline|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49563|NCT01903876|B2|Baseline|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
49564|NCT01903876|B1|Baseline|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
49565|NCT01903876|P2|Participant Flow|Bystander & Sexual Violence Prevention|A 3-hour web-based program designed to teach male college student bystanders to intervene.
49566|NCT01903876|P1|Participant Flow|General Health Promotion|A 3-hour general mental health web-based program.
49567|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
49568|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
49569|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
49570|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
49571|NCT01903876|E2|Reported Event|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
49572|NCT01903876|E1|Reported Event|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
49573|NCT01903720|B1|Baseline|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49574|NCT01903720|P1|Participant Flow|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49575|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49576|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49577|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49578|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49579|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49580|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49581|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49582|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49583|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
49584|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
52683|NCT01877278|P2|Participant Flow|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
49590|NCT01903460|B3|Baseline|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49591|NCT01903460|B2|Baseline|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49592|NCT01903460|B1|Baseline|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49593|NCT01903460|P4|Participant Flow|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49594|NCT01903460|P3|Participant Flow|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49595|NCT01903460|P2|Participant Flow|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49596|NCT01903460|P1|Participant Flow|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49597|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49598|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
49599|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49600|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49601|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49602|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
49603|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49604|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49605|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49606|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
49607|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49608|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49609|NCT01903460|E3|Reported Event|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
49610|NCT01903460|E2|Reported Event|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
49611|NCT01903460|E1|Reported Event|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
49612|NCT01903265|B3|Baseline|Total|Total of all reporting groups
49613|NCT01903265|B2|Baseline|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)"
49614|NCT01903265|B1|Baseline|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49615|NCT01903265|P2|Participant Flow|Placebo|1 tablet of placebo sublingually each day at bedtime for 12 weeks.
49616|NCT01903265|P1|Participant Flow|TNX-102 SL 2.8 mg|1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
49617|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49618|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49654|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49619|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49620|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49621|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49622|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49623|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49624|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49625|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49626|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49627|NCT01903265|E2|Reported Event|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49628|NCT01903265|E1|Reported Event|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
49629|NCT01903187|B3|Baseline|Total|Total of all reporting groups
49630|NCT01903187|B2|Baseline|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
49631|NCT01903187|B1|Baseline|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49632|NCT01903187|P2|Participant Flow|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
49633|NCT01903187|P1|Participant Flow|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49634|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49635|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49636|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49637|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49638|NCT01903187|O2|Outcome|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
49639|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49640|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49641|NCT01903187|E2|Reported Event|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram~Subjects exited after 1 month follow up"
49642|NCT01903187|E1|Reported Event|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
49643|NCT01903148|B3|Baseline|Total|Total of all reporting groups
49644|NCT01903148|B2|Baseline|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49645|NCT01903148|B1|Baseline|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49646|NCT01903148|P1|Participant Flow|Patients With Anemia and CKD|Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
49647|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49648|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49649|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49650|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49651|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49652|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49653|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49655|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49656|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49657|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49658|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49659|NCT01903148|E2|Reported Event|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
49660|NCT01903148|E1|Reported Event|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
49661|NCT01903005|B3|Baseline|Total|Total of all reporting groups
49662|NCT01903005|B2|Baseline|OX219-007 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49663|NCT01903005|B1|Baseline|OX219-006 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49664|NCT01903005|P1|Participant Flow|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49665|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49666|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49667|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49668|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49669|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49670|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49671|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49672|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49673|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49674|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49675|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49676|NCT01903005|E1|Reported Event|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
49677|NCT01902888|B1|Baseline|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
49678|NCT01902888|P1|Participant Flow|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
49679|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
49680|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
49681|NCT01902888|E1|Reported Event|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
49682|NCT01902758|B3|Baseline|Total|Total of all reporting groups
49683|NCT01902758|B2|Baseline|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
49684|NCT01902758|B1|Baseline|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
49685|NCT01902758|P2|Participant Flow|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
49686|NCT01902758|P1|Participant Flow|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
49687|NCT01902758|O2|Outcome|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
52684|NCT01877278|P1|Participant Flow|Active|"emitting group~Wearable pulsed electromagnetic fields"
49688|NCT01902758|O1|Outcome|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
49689|NCT01902758|E2|Reported Event|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
49690|NCT01902758|E1|Reported Event|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
49691|NCT01902303|B3|Baseline|Total|Total of all reporting groups
49692|NCT01902303|B2|Baseline|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and received active test article
49693|NCT01902303|B1|Baseline|Matching Placebo|Placebo Safety Population - All subjects enrolled and received placebo test article
49694|NCT01902303|P2|Participant Flow|BTL-TML-HSV|"Experimental Product~BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
49695|NCT01902303|P1|Participant Flow|Matching Placebo|"Matching Placebo~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
49696|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol
49697|NCT01902303|O1|Outcome|Matching Placebo|Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol
49698|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition
49699|NCT01902303|O1|Outcome|Matching Placebo|Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition
49700|NCT01902303|E2|Reported Event|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
49701|NCT01902303|E1|Reported Event|Matching Placebo|Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.
49702|NCT01902134|B7|Baseline|Total|Total of all reporting groups
49703|NCT01902134|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
49704|NCT01902134|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
49705|NCT01902134|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
49706|NCT01902134|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
49707|NCT01902134|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
49708|NCT01902134|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
49709|NCT01902134|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
49710|NCT01902134|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
49711|NCT01902134|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
49712|NCT01902134|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
49713|NCT01902134|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
49714|NCT01902134|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
49715|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);
49716|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
49717|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
49718|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
49719|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49720|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49721|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49722|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49723|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49724|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
49725|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
49726|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
49727|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
102077|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
49728|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
49729|NCT01902134|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses.
49730|NCT01902134|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses.
49731|NCT01902134|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
49732|NCT01902134|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses.
49733|NCT01902134|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
49734|NCT01902134|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
49735|NCT01901588|B3|Baseline|Total|Total of all reporting groups
49736|NCT01901588|B2|Baseline|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49737|NCT01901588|B1|Baseline|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49738|NCT01901588|P2|Participant Flow|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49739|NCT01901588|P1|Participant Flow|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49740|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49741|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49742|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49743|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49744|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49745|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49746|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49747|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49748|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49749|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49750|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49751|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49752|NCT01901588|E2|Reported Event|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
49753|NCT01901588|E1|Reported Event|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
49754|NCT01901575|B1|Baseline|Remifentanil|Remifentanil IV PCA
49755|NCT01901575|P1|Participant Flow|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
49756|NCT01901575|O1|Outcome|Remifentanil IV PCA|"patients with PVC's prior to administration of remifentanil~Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol"
49757|NCT01901575|E1|Reported Event|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
49758|NCT01901393|B3|Baseline|Total|Total of all reporting groups
49759|NCT01901393|B2|Baseline|Ketorolac|"30mg ketorolac~Ketorolac"
49760|NCT01901393|B1|Baseline|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49761|NCT01901393|P2|Participant Flow|Ketorolac|"30mg ketorolac~Ketorolac"
49762|NCT01901393|P1|Participant Flow|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49763|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49764|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49765|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49766|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49767|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49768|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49769|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49770|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49771|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49772|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49773|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
49774|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49775|NCT01901393|E2|Reported Event|Ketorolac|"30mg ketorolac~Ketorolac"
49776|NCT01901393|E1|Reported Event|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
49777|NCT01901341|B3|Baseline|Total|Total of all reporting groups
49778|NCT01901341|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
49779|NCT01901341|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49780|NCT01901341|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
49781|NCT01901341|P1|Participant Flow|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49782|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49783|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49784|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49785|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49786|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49787|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49788|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a12-week treatment period
49789|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49790|NCT01901341|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
49791|NCT01901341|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49792|NCT01901328|B3|Baseline|Total|Total of all reporting groups
49793|NCT01901328|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
49794|NCT01901328|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49795|NCT01901328|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
49796|NCT01901328|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
49797|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49798|NCT01901328|O1|Outcome|CB-5945|0.25 milligrams CB-5945 administered orally BID for a 12-week treatment period
49799|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49800|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49801|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49802|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49803|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49804|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49805|NCT01901328|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
49806|NCT01901328|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49807|NCT01901302|B3|Baseline|Total|Total of all reporting groups
49808|NCT01901302|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
49809|NCT01901302|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49810|NCT01901302|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
49811|NCT01901302|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
49812|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49813|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49814|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49815|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49816|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49817|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49818|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
49819|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49820|NCT01901302|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
49821|NCT01901302|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
49822|NCT01901250|B3|Baseline|Total|Total of all reporting groups
49823|NCT01901250|B2|Baseline|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49824|NCT01901250|B1|Baseline|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49825|NCT01901250|P2|Participant Flow|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49826|NCT01901250|P1|Participant Flow|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49855|NCT01900067|P1|Participant Flow|Active Warming|"BARRIER® EasyWarm Active Self-Warming Blanket~BARRIER® EasyWarm Active Self-Warming Blanket"
49827|NCT01901250|O2|Outcome|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49828|NCT01901250|O1|Outcome|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49829|NCT01901250|E2|Reported Event|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49830|NCT01901250|E1|Reported Event|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
49831|NCT01901185|B1|Baseline|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49832|NCT01901185|P1|Participant Flow|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49833|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49834|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49835|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49836|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
49837|NCT01901185|E1|Reported Event|Autoinjector A/Etanercept|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
49838|NCT01900249|B4|Baseline|Total|Total of all reporting groups
49839|NCT01900249|B3|Baseline|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
49840|NCT01900249|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
49841|NCT01900249|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
49842|NCT01900249|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
49843|NCT01900249|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
49844|NCT01900249|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
49845|NCT01900249|O3|Outcome|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
49846|NCT01900249|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
49847|NCT01900249|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
49848|NCT01900249|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
49849|NCT01900249|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
49850|NCT01900249|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
49851|NCT01900067|B3|Baseline|Total|Total of all reporting groups
49852|NCT01900067|B2|Baseline|Control|no active warming, standard of care
49853|NCT01900067|B1|Baseline|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
49854|NCT01900067|P2|Participant Flow|Control|no active warming, standard of care
49865|NCT01899911|B1|Baseline|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
49866|NCT01899911|P1|Participant Flow|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
49867|NCT01899911|O1|Outcome|Vital Signs Patch (VSP)|Infrared and Red absorbance measurement on chest
49868|NCT01899911|E1|Reported Event|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
49869|NCT01899742|B3|Baseline|Total|Total of all reporting groups
49870|NCT01899742|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49871|NCT01899742|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49872|NCT01899742|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49873|NCT01899742|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg) once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49874|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49875|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49876|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49877|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49878|NCT01899742|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49879|NCT01899742|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
49880|NCT01899677|B3|Baseline|Total|Total of all reporting groups
49881|NCT01899677|B2|Baseline|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49882|NCT01899677|B1|Baseline|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49883|NCT01899677|P2|Participant Flow|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49884|NCT01899677|P1|Participant Flow|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49885|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49886|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49887|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49888|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49889|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49890|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49891|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49892|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
50013|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
49893|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49894|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49895|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49896|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49897|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49898|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49899|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49900|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49901|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49902|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49903|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49904|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49905|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49906|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49907|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49908|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49909|NCT01899677|E2|Reported Event|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
49910|NCT01899677|E1|Reported Event|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
49911|NCT01899144|B1|Baseline|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
49912|NCT01899144|P1|Participant Flow|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
49913|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
49914|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
49915|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
49916|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
49917|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
49918|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
49919|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
49920|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
49921|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
49922|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
49923|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
49924|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
49925|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
49926|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
49927|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
49928|NCT01899144|E5|Reported Event|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
49929|NCT01899144|E4|Reported Event|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
49930|NCT01899144|E3|Reported Event|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
49931|NCT01899144|E2|Reported Event|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
49932|NCT01899144|E1|Reported Event|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
49933|NCT01898884|B6|Baseline|Total|Total of all reporting groups
49934|NCT01898884|B5|Baseline|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
49935|NCT01898884|B4|Baseline|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
49936|NCT01898884|B3|Baseline|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
49937|NCT01898884|B2|Baseline|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
49938|NCT01898884|B1|Baseline|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
49939|NCT01898884|P9|Participant Flow|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49940|NCT01898884|P8|Participant Flow|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49941|NCT01898884|P7|Participant Flow|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49942|NCT01898884|P6|Participant Flow|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49943|NCT01898884|P5|Participant Flow|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
49944|NCT01898884|P4|Participant Flow|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
49945|NCT01898884|P3|Participant Flow|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
49946|NCT01898884|P2|Participant Flow|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
49947|NCT01898884|P1|Participant Flow|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
52685|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
49948|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49949|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49950|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49951|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49952|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49953|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49954|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49955|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49956|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49957|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49958|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49959|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49960|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49961|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49962|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49963|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49964|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49965|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49966|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49967|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49968|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49969|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49970|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49971|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49972|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49973|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49974|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49975|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49976|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49977|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50055|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
49978|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49979|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49980|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49981|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49982|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49983|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49984|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49985|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49986|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49987|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49988|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49989|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49990|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49991|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49992|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49993|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49994|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49995|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49996|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49997|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
49998|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
49999|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50000|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50001|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50002|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50003|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50004|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50005|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50006|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50007|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50008|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50009|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50010|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50011|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50012|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50014|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50015|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50016|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50017|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50018|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50019|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50020|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50021|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50022|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50023|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50024|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50025|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50026|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50027|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50028|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50029|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50030|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50031|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50032|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50033|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50034|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50035|NCT01898884|O2|Outcome|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50036|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50037|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50038|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50039|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50040|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50041|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50042|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50043|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50044|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50045|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50046|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50047|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50048|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50049|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50050|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50051|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50052|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50053|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50054|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
50056|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50057|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50058|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50059|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50060|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50061|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50062|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50063|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
50064|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50065|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50066|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50067|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50068|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50069|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50070|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50071|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50072|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
50073|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50074|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50075|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50076|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50077|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50078|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50079|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50080|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50081|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
50082|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
50083|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
50084|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
50085|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
50086|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
50087|NCT01898884|E9|Reported Event|Multiple Dose VP 20629 900mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50088|NCT01898884|E8|Reported Event|Multiple Dose VP 20629 600mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50089|NCT01898884|E7|Reported Event|Multiple Dose VP 20629 300mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
50090|NCT01898884|E6|Reported Event|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
50091|NCT01898884|E5|Reported Event|Single Dose VP 20629 1200mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.
102078|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
50092|NCT01898884|E4|Reported Event|Single Dose VP 20629 900mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.
50093|NCT01898884|E3|Reported Event|Single Dose VP 20629 450mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.
50094|NCT01898884|E2|Reported Event|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.
50095|NCT01898884|E1|Reported Event|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.
50096|NCT01898442|B4|Baseline|Total|Total of all reporting groups
50097|NCT01898442|B3|Baseline|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50098|NCT01898442|B2|Baseline|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50099|NCT01898442|B1|Baseline|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50100|NCT01898442|P3|Participant Flow|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50101|NCT01898442|P2|Participant Flow|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50102|NCT01898442|P1|Participant Flow|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50103|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50104|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50105|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50106|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50107|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50108|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50109|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50110|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50111|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50112|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50113|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50114|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50115|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50116|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50117|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50118|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50119|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50120|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50121|NCT01898442|E3|Reported Event|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
50122|NCT01898442|E2|Reported Event|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
50123|NCT01898442|E1|Reported Event|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
50124|NCT01898286|B1|Baseline|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50125|NCT01898286|P1|Participant Flow|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50126|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50127|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50128|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50129|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50130|NCT01898286|E1|Reported Event|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
50131|NCT01898208|B4|Baseline|Total|Total of all reporting groups
50158|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50132|NCT01898208|B3|Baseline|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50133|NCT01898208|B2|Baseline|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50134|NCT01898208|B1|Baseline|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50135|NCT01898208|P3|Participant Flow|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50136|NCT01898208|P2|Participant Flow|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50137|NCT01898208|P1|Participant Flow|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50138|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50139|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50140|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50141|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50142|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50143|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50144|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50145|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50146|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50147|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50148|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50149|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50150|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50151|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50152|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50153|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50154|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50155|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50156|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50157|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50189|NCT01897402|B3|Baseline|Total|Total of all reporting groups
50159|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50160|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50161|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50162|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50163|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50164|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50165|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50166|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50167|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50168|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50169|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50170|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50171|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50172|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50173|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50174|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50175|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50176|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50177|NCT01898208|E3|Reported Event|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
50178|NCT01898208|E2|Reported Event|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
50179|NCT01898208|E1|Reported Event|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
50180|NCT01897727|B3|Baseline|Total|Total of all reporting groups
50181|NCT01897727|B2|Baseline|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
50182|NCT01897727|B1|Baseline|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
50183|NCT01897727|P2|Participant Flow|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
50184|NCT01897727|P1|Participant Flow|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
50185|NCT01897727|O2|Outcome|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
50186|NCT01897727|O1|Outcome|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
50187|NCT01897727|E2|Reported Event|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
50188|NCT01897727|E1|Reported Event|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
50190|NCT01897402|B2|Baseline|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50191|NCT01897402|B1|Baseline|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50192|NCT01897402|P2|Participant Flow|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50193|NCT01897402|P1|Participant Flow|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50194|NCT01897402|O2|Outcome|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50195|NCT01897402|O1|Outcome|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50196|NCT01897402|O4|Outcome|US Licensed Vaccine - Female|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50197|NCT01897402|O3|Outcome|US Licensed Vaccine - Male|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50198|NCT01897402|O2|Outcome|Test Vaccine - Female|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50199|NCT01897402|O1|Outcome|Test Vaccine - Male|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50200|NCT01897402|O2|Outcome|US Licensed Vaccine|"Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid."
50201|NCT01897402|O1|Outcome|Test Vaccine|"NmVac4-A/C/Y/W-135-DT™ conjugate vaccine~Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid."
50202|NCT01897402|E2|Reported Event|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
50203|NCT01897402|E1|Reported Event|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
50204|NCT01897285|B1|Baseline|All Participants: AQUACEL® Foam Adhesive Dressings|"Original adhesive + test adhesive~AQUACEL® foam adhesive dressings"
50205|NCT01897285|P1|Participant Flow|All Study Participants|"Original adhesive and Test adhesive on right and left upper arm and right and left lower back.~AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back"
50206|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
50207|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
50208|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
50209|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
50210|NCT01897285|E2|Reported Event|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
50211|NCT01897285|E1|Reported Event|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
50212|NCT01897233|B1|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
50213|NCT01897233|P1|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
50214|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50215|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50216|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50217|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50218|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50219|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50220|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50221|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50222|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks
50223|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50224|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50225|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50226|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50227|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50419|NCT01896115|O1|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
50228|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50229|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50230|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50231|NCT01897233|E3|Reported Event|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
50232|NCT01897233|E2|Reported Event|Part A Cohort 2: LUM/IVA|Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50233|NCT01897233|E1|Reported Event|Part A Cohort 1: LUM/IVA|Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
50234|NCT01897025|B3|Baseline|Total|Total of all reporting groups
50235|NCT01897025|B2|Baseline|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
50236|NCT01897025|B1|Baseline|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
50237|NCT01897025|P2|Participant Flow|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
50238|NCT01897025|P1|Participant Flow|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
50239|NCT01897025|O2|Outcome|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
50240|NCT01897025|O1|Outcome|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
50241|NCT01897025|E2|Reported Event|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
50242|NCT01897025|E1|Reported Event|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
50243|NCT01896687|B3|Baseline|Total|Total of all reporting groups
50244|NCT01896687|B2|Baseline|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
50245|NCT01896687|B1|Baseline|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
50420|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
50246|NCT01896687|P2|Participant Flow|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
50247|NCT01896687|P1|Participant Flow|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
50248|NCT01896687|O2|Outcome|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
50249|NCT01896687|O1|Outcome|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
50250|NCT01896687|E2|Reported Event|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
50251|NCT01896687|E1|Reported Event|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
50252|NCT01896557|B3|Baseline|Total|Total of all reporting groups
50253|NCT01896557|B2|Baseline|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
50254|NCT01896557|B1|Baseline|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
50255|NCT01896557|P2|Participant Flow|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
50256|NCT01896557|P1|Participant Flow|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
50257|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
50258|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
50259|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
50260|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
50261|NCT01896557|E2|Reported Event|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
50262|NCT01896557|E1|Reported Event|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
50263|NCT01896544|B4|Baseline|Total|Total of all reporting groups
50264|NCT01896544|B3|Baseline|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50265|NCT01896544|B2|Baseline|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50266|NCT01896544|B1|Baseline|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50267|NCT01896544|P3|Participant Flow|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50268|NCT01896544|P2|Participant Flow|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50269|NCT01896544|P1|Participant Flow|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50270|NCT01896544|O3|Outcome|Cholecalciferol Dose 2|Oral suspension of cholecalciferol 400,000 IU
50271|NCT01896544|O2|Outcome|Cholecalciferol Dose 1|Oral suspension cholecalciferol 200,000 IU
50272|NCT01896544|O1|Outcome|Placebo|Oral suspension of placebo cholecalciferol
50273|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50274|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50275|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50276|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50277|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50278|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50279|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50280|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50281|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50282|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50283|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50284|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50513|NCT01895309|B1|Baseline|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
50285|NCT01896544|E3|Reported Event|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50286|NCT01896544|E2|Reported Event|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
50287|NCT01896544|E1|Reported Event|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
50288|NCT01896297|B1|Baseline|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
50289|NCT01896297|P1|Participant Flow|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
50290|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
50291|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
50292|NCT01896297|E1|Reported Event|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
50293|NCT01896206|B1|Baseline|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
50294|NCT01896206|P1|Participant Flow|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
50295|NCT01896206|O1|Outcome|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
50296|NCT01896206|E1|Reported Event|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
50297|NCT01896193|B5|Baseline|Total|Total of all reporting groups
50298|NCT01896193|B4|Baseline|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50299|NCT01896193|B3|Baseline|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50300|NCT01896193|B2|Baseline|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50301|NCT01896193|B1|Baseline|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50302|NCT01896193|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
50303|NCT01896193|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
50304|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50305|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50306|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50307|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50308|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50309|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50310|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50311|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50312|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50313|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50314|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50315|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50316|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50317|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50318|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50319|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50320|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
50321|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
50322|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
50323|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
50324|NCT01896193|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
50325|NCT01896193|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
50326|NCT01895101|B4|Baseline|Total|Total of all reporting groups
50514|NCT01895309|P2|Participant Flow|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
50327|NCT01895101|B3|Baseline|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50328|NCT01895101|B2|Baseline|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50329|NCT01895101|B1|Baseline|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50330|NCT01895101|P3|Participant Flow|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50331|NCT01895101|P2|Participant Flow|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50332|NCT01895101|P1|Participant Flow|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50333|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50334|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50335|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50336|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50337|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50338|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50339|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50340|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50341|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50421|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
102079|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
50342|NCT01895101|E3|Reported Event|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
50343|NCT01895101|E2|Reported Event|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
50344|NCT01895101|E1|Reported Event|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
50345|NCT01895062|B3|Baseline|Total|Total of all reporting groups
50346|NCT01895062|B2|Baseline|no Intervention|Routine care is administered without the application of cNEP.
50347|NCT01895062|B1|Baseline|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
50348|NCT01895062|P2|Participant Flow|no Intervention|Routine care is administered without the application of cNEP.
50349|NCT01895062|P1|Participant Flow|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
50350|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
50351|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
50352|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
50353|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
50354|NCT01895062|E2|Reported Event|no Intervention|Routine care is administered without the application of cNEP.
50355|NCT01895062|E1|Reported Event|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
50356|NCT01894984|B3|Baseline|Total|Total of all reporting groups
50357|NCT01894984|B2|Baseline|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50358|NCT01894984|B1|Baseline|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50359|NCT01894984|P2|Participant Flow|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50360|NCT01894984|P1|Participant Flow|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50361|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50362|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50363|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50364|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50365|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
102080|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
50366|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50367|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50368|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50369|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50370|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50371|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50372|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50373|NCT01894984|E2|Reported Event|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
50374|NCT01894984|E1|Reported Event|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
50375|NCT01894906|B3|Baseline|Total|Total of all reporting groups
50376|NCT01894906|B2|Baseline|Gambro 17R/21R (Group 2: Polyamide Membrane).|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
50377|NCT01894906|B1|Baseline|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
50378|NCT01894906|P2|Participant Flow|Gambro 17R/21R (Group 2: Polyamide Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
50379|NCT01894906|P1|Participant Flow|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
50380|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
50381|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
50382|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50383|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
50384|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50385|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50386|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
50387|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
50388|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50389|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
50390|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50391|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50392|NCT01894906|O1|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50393|NCT01894906|O3|Outcome|Baxter and Gambro Combined|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). This category includes the combined results of both groups.
50394|NCT01894906|O2|Outcome|Gambro Polyflux|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
50395|NCT01894906|O1|Outcome|Baxter CT-190|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
50396|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
50397|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
50422|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
50515|NCT01895309|P1|Participant Flow|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
50398|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50399|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
50400|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50401|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50402|NCT01894906|E6|Reported Event|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
50403|NCT01894906|E5|Reported Event|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
50404|NCT01894906|E4|Reported Event|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50405|NCT01894906|E3|Reported Event|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
50406|NCT01894906|E2|Reported Event|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50407|NCT01894906|E1|Reported Event|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
50408|NCT01896115|B1|Baseline|All Arms|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
50409|NCT01896115|P1|Participant Flow|All Arms|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current ventrally~Patients with a Vercise DBS system programmed to steer current dorsally."
50410|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
50411|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
50412|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
50413|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
50414|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
50415|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
50416|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
50417|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
50418|NCT01896115|O2|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
50423|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
50424|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
50425|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
50426|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
50427|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
50428|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
50429|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
50430|NCT01896115|E1|Reported Event|All Arms|"Patients with a Vercise DBS system programmed to 4 different settings including:~Short pulse widths (30 microseconds)~Conventional pulse widths (60 microseconds)~Steering current ventrally~Steering current dorsally"
50431|NCT01896050|B3|Baseline|Total|Total of all reporting groups
50432|NCT01896050|B2|Baseline|Tamoxifen|Subjects who started treatment with tamoxifen
50433|NCT01896050|B1|Baseline|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
50434|NCT01896050|P2|Participant Flow|Tamoxifen|Subjects who started treatment with tamoxifen
50435|NCT01896050|P1|Participant Flow|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
50436|NCT01896050|O2|Outcome|Tamoxifen|Tamoxifen-treated patients
50437|NCT01896050|O1|Outcome|Aromatase Inhibitor|Aromatase inhibitor-treated patients
50438|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
50439|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
50440|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
50441|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
50442|NCT01896050|E2|Reported Event|Tamoxifen|Subjects who started treatment with tamoxifen
50443|NCT01896050|E1|Reported Event|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
50444|NCT01895946|B3|Baseline|Total|Total of all reporting groups
50445|NCT01895946|B2|Baseline|Part B|Part B of the study
50446|NCT01895946|B1|Baseline|Part A|Part A of the study
50447|NCT01895946|P2|Participant Flow|Part B|Part B of the study
50448|NCT01895946|P1|Participant Flow|Part A|Part A of the study
50449|NCT01895946|O2|Outcome|Part B|Part B of the study
50450|NCT01895946|O1|Outcome|Part A|Part A of the study
50451|NCT01895946|O2|Outcome|Part B|Part B of the study
50452|NCT01895946|O1|Outcome|Part A|Part A of the study
50453|NCT01895946|O2|Outcome|Part B|Part B of the study
50454|NCT01895946|O1|Outcome|Part A|Part A of the study
50455|NCT01895946|O2|Outcome|Part B|Part B of the study
50456|NCT01895946|O1|Outcome|Part A|Part A of the study
50457|NCT01895946|O2|Outcome|Part B|Part B of the study
50458|NCT01895946|O1|Outcome|Part A|Part A of the study
50459|NCT01895946|O2|Outcome|Part B|Part B of the study
50460|NCT01895946|O1|Outcome|Part A|Part A of the study
50461|NCT01895946|O2|Outcome|Part B|Part B of the study
50462|NCT01895946|O1|Outcome|Part A|Part A of the study
50463|NCT01895946|E2|Reported Event|Part B|Part B of the study
50464|NCT01895946|E1|Reported Event|Part A|Part A of the study
50465|NCT01895634|B1|Baseline|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50466|NCT01895634|P1|Participant Flow|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50467|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50468|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50469|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50470|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50471|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50472|NCT01895634|E1|Reported Event|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
50473|NCT01895543|B1|Baseline|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50474|NCT01895543|P1|Participant Flow|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50475|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50476|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50477|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50478|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50479|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50480|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50481|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50482|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50483|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50484|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50485|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50486|NCT01895543|E1|Reported Event|EBX 10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
50487|NCT01895335|B1|Baseline|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50488|NCT01895335|P1|Participant Flow|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
50489|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50490|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50491|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50492|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50493|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50494|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50495|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50496|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50497|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50498|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50499|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50500|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50501|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50502|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50503|NCT01895335|E1|Reported Event|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
50504|NCT01895322|B1|Baseline|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50505|NCT01895322|P1|Participant Flow|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50506|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50507|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50508|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an increase of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50509|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
50510|NCT01895322|E1|Reported Event|OPC-41061|OPC-41061
50511|NCT01895309|B3|Baseline|Total|Total of all reporting groups
50516|NCT01895309|O4|Outcome|Enbrel (Etanercept) at Week 52|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
50517|NCT01895309|O3|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 52|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
50518|NCT01895309|O2|Outcome|Enbrel (Etanercept) at Week 24|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
50519|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 24|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
50520|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
50521|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
50522|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
50523|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
50524|NCT01895309|E2|Reported Event|Enbrel (Etanercept)|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
50525|NCT01895309|E1|Reported Event|SB4 (Proposed Biosimilar to Etanercept)|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
50526|NCT01894607|B1|Baseline|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
50527|NCT01894607|P1|Participant Flow|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
50528|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
50529|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
50530|NCT01894607|E1|Reported Event|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
50531|NCT01894581|B3|Baseline|Total|Total of all reporting groups
50532|NCT01894581|B2|Baseline|Normal Weight|BMI 18-25 kg/m2
50533|NCT01894581|B1|Baseline|Obese|BMI >= 30 kg/m2
50534|NCT01894581|P2|Participant Flow|Normal Weight|BMI 18-25 kg/m2
50535|NCT01894581|P1|Participant Flow|Obese|BMI >= 30 kg/m2
50536|NCT01894581|O2|Outcome|Normal Weight|BMI 18-25 kg/m2
50537|NCT01894581|O1|Outcome|Obese|BMI >= 30 kg/m2
50538|NCT01894581|E2|Reported Event|Normal Weight|BMI 18-25 kg/m2
50539|NCT01894581|E1|Reported Event|Obese|BMI >= 30 kg/m2
50540|NCT01894555|B1|Baseline|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
50541|NCT01894555|P1|Participant Flow|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
50542|NCT01894555|O1|Outcome|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
50543|NCT01894555|E1|Reported Event|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
50544|NCT01894256|B4|Baseline|Total|Total of all reporting groups
50545|NCT01894256|B3|Baseline|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50546|NCT01894256|B2|Baseline|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50547|NCT01894256|B1|Baseline|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50548|NCT01894256|P3|Participant Flow|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50549|NCT01894256|P2|Participant Flow|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50550|NCT01894256|P1|Participant Flow|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50551|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50552|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50553|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50554|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50555|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50556|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50557|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50558|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50559|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50560|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50561|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50562|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50563|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50564|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50565|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50566|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50567|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50568|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50569|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50570|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50653|NCT01893203|P1|Participant Flow|BF200 ALA vs MAL|5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
50571|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50572|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50573|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50574|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50575|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50576|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50577|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50578|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50579|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50580|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50581|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50582|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50583|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50584|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50585|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50586|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50587|NCT01894256|E6|Reported Event|Part B Moderate Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50588|NCT01894256|E5|Reported Event|Part B Mild Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50589|NCT01894256|E4|Reported Event|Part B Normal Renal Function|Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50590|NCT01894256|E3|Reported Event|Part A Moderate Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50654|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
50591|NCT01894256|E2|Reported Event|Part A Mild Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
50592|NCT01894256|E1|Reported Event|Part A Normal Renal Function|Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
50593|NCT01894100|B3|Baseline|Total|Total of all reporting groups
50594|NCT01894100|B2|Baseline|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50595|NCT01894100|B1|Baseline|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50596|NCT01894100|P2|Participant Flow|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50597|NCT01894100|P1|Participant Flow|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50598|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50599|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50600|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50601|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50602|NCT01894100|E2|Reported Event|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50603|NCT01894100|E1|Reported Event|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
50604|NCT01893567|B1|Baseline|Clobex Spray|Clobex Spray
50605|NCT01893567|P1|Participant Flow|Clobex Spray|Clobex Spray
50606|NCT01893567|O1|Outcome|Clobex Spray|Clobex Spray
50607|NCT01893567|E1|Reported Event|Clobex Spray|Clobex Spray
50608|NCT01893359|B4|Baseline|Total|Total of all reporting groups
50609|NCT01893359|B3|Baseline|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
50610|NCT01893359|B2|Baseline|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
50611|NCT01893359|B1|Baseline|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
50612|NCT01893359|P3|Participant Flow|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
50613|NCT01893359|P2|Participant Flow|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
50614|NCT01893359|P1|Participant Flow|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
50615|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
50616|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
50617|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
50618|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
50655|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
50656|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
50619|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
50620|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
50621|NCT01893359|E3|Reported Event|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
50622|NCT01893359|E2|Reported Event|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
50623|NCT01893359|E1|Reported Event|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
50624|NCT01893346|B5|Baseline|Total|Total of all reporting groups
50625|NCT01893346|B4|Baseline|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50626|NCT01893346|B3|Baseline|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50627|NCT01893346|B2|Baseline|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
50628|NCT01893346|B1|Baseline|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
50629|NCT01893346|P4|Participant Flow|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50630|NCT01893346|P3|Participant Flow|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50631|NCT01893346|P2|Participant Flow|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
50632|NCT01893346|P1|Participant Flow|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
50633|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
50634|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
50635|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
50636|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
50637|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
50638|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
50639|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
50640|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
50641|NCT01893346|E4|Reported Event|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50642|NCT01893346|E3|Reported Event|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
50643|NCT01893346|E2|Reported Event|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
50644|NCT01893346|E1|Reported Event|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
50645|NCT01893281|B1|Baseline|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50646|NCT01893281|P1|Participant Flow|Topical Testosterone Solution|Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50647|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50648|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50649|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50650|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50651|NCT01893281|E1|Reported Event|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
50652|NCT01893203|B1|Baseline|BF-200 ALA vs MAL|BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
50657|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
50658|NCT01893203|E1|Reported Event|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
50659|NCT01892657|B1|Baseline|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
50660|NCT01892657|P1|Participant Flow|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
50661|NCT01892657|O13|Outcome|Challenge Patch (Alternate Site) - 96 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
50662|NCT01892657|O12|Outcome|Challenge Patch (Alternate Site) - 48 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
50663|NCT01892657|O11|Outcome|Challenge Patch (Original Site) - 96 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
50664|NCT01892657|O10|Outcome|Challenge Patch (Original Site) - 48 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
50665|NCT01892657|O9|Outcome|Patch 9|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50666|NCT01892657|O8|Outcome|Patch 8|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50667|NCT01892657|O7|Outcome|Patch 7|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50668|NCT01892657|O6|Outcome|Patch 6|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50669|NCT01892657|O5|Outcome|Patch 5|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50670|NCT01892657|O4|Outcome|Patch 4|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50671|NCT01892657|O3|Outcome|Patch 3|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50672|NCT01892657|O2|Outcome|Patch 2|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50673|NCT01892657|O1|Outcome|Patch 1|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
50674|NCT01892657|E1|Reported Event|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
50675|NCT01892189|B10|Baseline|Total|Total of all reporting groups
50676|NCT01892189|B9|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50677|NCT01892189|B8|Baseline|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50678|NCT01892189|B7|Baseline|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50679|NCT01892189|B6|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50680|NCT01892189|B5|Baseline|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50681|NCT01892189|B4|Baseline|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50941|NCT01890954|E2|Reported Event|Usual Care Without DiAs System (CGM Only)|8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
50682|NCT01892189|B3|Baseline|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50683|NCT01892189|B2|Baseline|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50684|NCT01892189|B1|Baseline|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50685|NCT01892189|P9|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50686|NCT01892189|P8|Participant Flow|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50687|NCT01892189|P7|Participant Flow|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50688|NCT01892189|P6|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50689|NCT01892189|P5|Participant Flow|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50690|NCT01892189|P4|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50691|NCT01892189|P3|Participant Flow|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50692|NCT01892189|P2|Participant Flow|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50769|NCT01891669|B6|Baseline|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50971|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
50693|NCT01892189|P1|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
50694|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
50695|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50696|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50697|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50698|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50699|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
50700|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50701|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50702|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50703|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50704|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
50705|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50706|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50707|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50708|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50709|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
50710|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50711|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50712|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50713|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50714|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50715|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50716|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50717|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50718|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50719|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50720|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50721|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50722|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50723|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50724|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50725|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50726|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50727|NCT01892189|E5|Reported Event|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
50728|NCT01892189|E4|Reported Event|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50729|NCT01892189|E3|Reported Event|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
50730|NCT01892189|E2|Reported Event|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
50731|NCT01892189|E1|Reported Event|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
51214|NCT01890031|E5|Reported Event|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
50732|NCT01892020|B1|Baseline|All Subjects|In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
50733|NCT01892020|P2|Participant Flow|Group B (BHI 50 - BIAsp 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
50734|NCT01892020|P1|Participant Flow|Group A (BIAsp 50 - BHI 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
50735|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50736|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50737|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50738|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50739|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50740|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50741|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50742|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50743|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50744|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50745|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50746|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50747|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
50748|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
50749|NCT01892020|E2|Reported Event|BHI 50|This arm included the subjects received BHI 50.
50750|NCT01892020|E1|Reported Event|BIAsp 50|This arm included the subjects received BIAsp 50.
50751|NCT01891734|B3|Baseline|Total|Total of all reporting groups
50752|NCT01891734|B2|Baseline|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
50753|NCT01891734|B1|Baseline|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
50754|NCT01891734|P2|Participant Flow|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
50755|NCT01891734|P1|Participant Flow|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
50770|NCT01891669|B5|Baseline|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
52686|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
50756|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
50757|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
50758|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
50759|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
50760|NCT01891734|O2|Outcome|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
50761|NCT01891734|O1|Outcome|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
50762|NCT01891734|E2|Reported Event|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
50763|NCT01891734|E1|Reported Event|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
50764|NCT01891669|B11|Baseline|Total|Total of all reporting groups
50765|NCT01891669|B10|Baseline|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50766|NCT01891669|B9|Baseline|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50767|NCT01891669|B8|Baseline|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50768|NCT01891669|B7|Baseline|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50771|NCT01891669|B4|Baseline|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50772|NCT01891669|B3|Baseline|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50773|NCT01891669|B2|Baseline|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50774|NCT01891669|B1|Baseline|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50775|NCT01891669|P10|Participant Flow|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50776|NCT01891669|P9|Participant Flow|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50777|NCT01891669|P8|Participant Flow|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50778|NCT01891669|P7|Participant Flow|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50779|NCT01891669|P6|Participant Flow|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50780|NCT01891669|P5|Participant Flow|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50781|NCT01891669|P4|Participant Flow|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50782|NCT01891669|P3|Participant Flow|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50783|NCT01891669|P2|Participant Flow|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50784|NCT01891669|P1|Participant Flow|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50785|NCT01891669|O9|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50786|NCT01891669|O8|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50787|NCT01891669|O7|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50788|NCT01891669|O6|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50789|NCT01891669|O5|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50790|NCT01891669|O4|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50791|NCT01891669|O3|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50792|NCT01891669|O2|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50793|NCT01891669|O1|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50794|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50795|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50796|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50797|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50798|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50799|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50800|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50801|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50802|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50803|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50804|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50805|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50806|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50807|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50808|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50809|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50810|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50811|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50812|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50813|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50814|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50815|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50816|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50817|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50818|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50819|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50820|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50821|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50822|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50823|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50824|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50825|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50826|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50827|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50828|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
102081|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
50829|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50830|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50831|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50832|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50833|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50834|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50835|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50836|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50837|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50838|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50839|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50840|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50841|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50842|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50843|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50844|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50845|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50846|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50847|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50848|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50849|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50850|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50851|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50852|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50853|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50854|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50855|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50856|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50857|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
102082|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
50858|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50859|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50860|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50861|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50862|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50863|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50864|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50865|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50866|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50867|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50868|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50869|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50870|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50871|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50872|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50873|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50874|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50875|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50876|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50877|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50878|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50879|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50880|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50881|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50882|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50883|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50884|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50885|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50886|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
102083|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
50887|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50888|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50889|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50890|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50891|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50892|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50893|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50894|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50895|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50896|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50897|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50898|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50899|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50900|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50901|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50902|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50903|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50904|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50905|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50906|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50907|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50908|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50909|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50910|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50911|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50912|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50913|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50914|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50915|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
102084|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
50916|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50917|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50918|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50919|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50920|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50921|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50922|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50923|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50924|NCT01891669|E10|Reported Event|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50925|NCT01891669|E9|Reported Event|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50926|NCT01891669|E8|Reported Event|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50927|NCT01891669|E7|Reported Event|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50928|NCT01891669|E6|Reported Event|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50929|NCT01891669|E5|Reported Event|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50930|NCT01891669|E4|Reported Event|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50931|NCT01891669|E3|Reported Event|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50932|NCT01891669|E2|Reported Event|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50933|NCT01891669|E1|Reported Event|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
50934|NCT01890954|B3|Baseline|Total|Total of all reporting groups
50935|NCT01890954|B2|Baseline|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
50936|NCT01890954|B1|Baseline|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
50937|NCT01890954|P2|Participant Flow|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
50938|NCT01890954|P1|Participant Flow|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
50939|NCT01890954|O2|Outcome|Usual Care Without DiAs System (CGM Only)|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
50940|NCT01890954|O1|Outcome|Closed Loop Control With DiAs System|8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
52687|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
50942|NCT01890954|E1|Reported Event|Closed Loop Control With DiAs System|"8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch~Diabetes Assistant (DiAs)"
50943|NCT01890915|B3|Baseline|Total|Total of all reporting groups
50944|NCT01890915|B2|Baseline|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50945|NCT01890915|B1|Baseline|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50946|NCT01890915|P2|Participant Flow|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50947|NCT01890915|P1|Participant Flow|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50948|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50949|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50950|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50951|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50952|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50953|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50954|NCT01890915|E2|Reported Event|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50955|NCT01890915|E1|Reported Event|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
50956|NCT01890785|B7|Baseline|Total|Total of all reporting groups
50957|NCT01890785|B6|Baseline|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
50958|NCT01890785|B5|Baseline|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
50959|NCT01890785|B4|Baseline|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
50960|NCT01890785|B3|Baseline|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
50961|NCT01890785|B2|Baseline|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
50962|NCT01890785|B1|Baseline|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
50963|NCT01890785|P6|Participant Flow|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
50964|NCT01890785|P5|Participant Flow|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
50965|NCT01890785|P4|Participant Flow|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
50966|NCT01890785|P3|Participant Flow|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
50967|NCT01890785|P2|Participant Flow|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
50968|NCT01890785|P1|Participant Flow|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
50969|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
50970|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
50972|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
50973|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
50974|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
50975|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
50976|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
50977|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
50978|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
50979|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
50980|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
50981|NCT01890785|E3|Reported Event|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
50982|NCT01890785|E2|Reported Event|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
50983|NCT01890785|E1|Reported Event|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
50984|NCT01890746|B3|Baseline|Total|Total of all reporting groups
50985|NCT01890746|B2|Baseline|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50986|NCT01890746|B1|Baseline|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50987|NCT01890746|P2|Participant Flow|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50988|NCT01890746|P1|Participant Flow|Eltrombopag (ELT) QD|Par. received (rec) first line induction (IDN) chemotherapy (CTY) consisting of daunorubicin (DAU) bolus intravenous (IV) infusion (INF) on Days (D) 1-3 at a dose of 90 milligrams (mg)/square meter (m^2) for Par. 18-60 year (yr) or 60 mg/m^2 for >60 yr plus cytarabine (CB) 100 mg/m^2 continuous IV INF on D1-7. Par. rec ELT as 200 mg (100 mg for East-Asian Heritage [EAH]) once daily (QD) oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If platelet (PT) count was not >100 Giga (Gi)/Liter (L) after 7D the dose was increased to 300 mg (150 mg for EAH) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42D from the start of the CTY IDN cycle. Par. not aplastic after first cycle of IDN CTY rec re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus CB 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50989|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50990|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50991|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51024|NCT01890642|B1|Baseline|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
50992|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50993|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50994|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50995|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50996|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50997|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
50998|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
50999|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51000|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51001|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51022|NCT01890642|B3|Baseline|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51023|NCT01890642|B2|Baseline|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51050|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51002|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51003|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51004|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51005|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51006|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51007|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
51008|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51009|NCT01890746|E2|Reported Event|Placebo QD|Participants received first line induction chemotherapy consisted of daunorubicin bolus IV infusion on Days 1 – 3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants &gt;60 years of age plus cytarabine continuous IV infusion on Days 1 – 7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose started on Day 4 of initial induction chemotherapy at least 20 hours after end of Day 3 daunorubicin infusion up to a maximum duration of 42 days.
51010|NCT01890746|E1|Reported Event|Eltrombopag QD|Par. received IDN CTY of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.&gt;60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg QD oral dose started on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not &gt;100 Gi/L after 7 days the dose was increased to 300 mg QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par.who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
51011|NCT01890694|B3|Baseline|Total|Total of all reporting groups
51012|NCT01890694|B2|Baseline|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
51013|NCT01890694|B1|Baseline|Placebo|Subjects will receive placebo once daily.
51014|NCT01890694|P2|Participant Flow|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
51015|NCT01890694|P1|Participant Flow|Placebo|Subjects will receive placebo once daily.
51016|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
51017|NCT01890694|O2|Outcome|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
51018|NCT01890694|O1|Outcome|Placebo|Subjects will receive placebo once daily.
51019|NCT01890694|E2|Reported Event|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
51020|NCT01890694|E1|Reported Event|Placebo|Subjects will receive placebo once daily.
51021|NCT01890642|B4|Baseline|Total|Total of all reporting groups
102085|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
51025|NCT01890642|P3|Participant Flow|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51026|NCT01890642|P2|Participant Flow|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51027|NCT01890642|P1|Participant Flow|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51028|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51029|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51030|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51031|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51032|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51033|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51034|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51035|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51036|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51037|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51038|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51039|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51040|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51041|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51042|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51043|NCT01890642|E3|Reported Event|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
51044|NCT01890642|E2|Reported Event|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51045|NCT01890642|E1|Reported Event|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
51046|NCT01890577|B1|Baseline|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51047|NCT01890577|P1|Participant Flow|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51048|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51049|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
52688|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
51051|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51052|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51053|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51054|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51055|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51056|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51057|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51058|NCT01890577|E1|Reported Event|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
51059|NCT01890512|B1|Baseline|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
51060|NCT01890512|P1|Participant Flow|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
51061|NCT01890512|O1|Outcome|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
51062|NCT01890512|E1|Reported Event|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
51063|NCT01890473|B3|Baseline|Total|Total of all reporting groups
51064|NCT01890473|B2|Baseline|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
51065|NCT01890473|B1|Baseline|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
51066|NCT01890473|P2|Participant Flow|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
51067|NCT01890473|P1|Participant Flow|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
51068|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51069|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51070|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51071|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51072|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
51073|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
51074|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51075|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51076|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51077|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51078|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51079|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51080|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51081|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51082|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51083|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51084|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
51085|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
51086|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
51087|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51088|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
51089|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
51090|NCT01890473|E2|Reported Event|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a PFS.
51091|NCT01890473|E1|Reported Event|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
51092|NCT01890343|B4|Baseline|Total|Total of all reporting groups
51093|NCT01890343|B3|Baseline|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51094|NCT01890343|B2|Baseline|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51095|NCT01890343|B1|Baseline|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
51096|NCT01890343|P3|Participant Flow|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51097|NCT01890343|P2|Participant Flow|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51098|NCT01890343|P1|Participant Flow|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
51099|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51100|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51101|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
51102|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51103|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51104|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
51105|NCT01890343|E3|Reported Event|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51106|NCT01890343|E2|Reported Event|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
51107|NCT01890343|E1|Reported Event|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
51108|NCT01890148|B1|Baseline|AZD5069|AZD5069 45mg oral twice daily (BID)
51109|NCT01890148|P1|Participant Flow|AZD5069|AZD5069 45mg oral twice daily (BID)
51110|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51111|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51112|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51113|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51114|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51115|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51116|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51117|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51118|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51119|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51120|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51121|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51122|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
51123|NCT01890148|E1|Reported Event|AZD5069|AZD5069 45mg oral twice daily (BID)
51124|NCT01890122|B5|Baseline|Total|Total of all reporting groups
51125|NCT01890122|B4|Baseline|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51126|NCT01890122|B3|Baseline|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51127|NCT01890122|B2|Baseline|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51128|NCT01890122|B1|Baseline|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51129|NCT01890122|P4|Participant Flow|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51130|NCT01890122|P3|Participant Flow|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51131|NCT01890122|P2|Participant Flow|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51132|NCT01890122|P1|Participant Flow|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51213|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
51133|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51134|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51135|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51136|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51137|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51138|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51139|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51140|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51141|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51142|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51143|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51144|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51145|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51146|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51147|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51148|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51149|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51150|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51151|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51152|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51153|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51154|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51155|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51156|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51157|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51158|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
52689|NCT01877278|E2|Reported Event|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
51159|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51160|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51161|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51162|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51163|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51164|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51165|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51166|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51167|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51168|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51169|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51170|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51171|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51172|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51173|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51174|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51175|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51176|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51177|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51178|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51179|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51180|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51181|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51182|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51183|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51184|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
52690|NCT01877278|E1|Reported Event|Active|"emitting group~Wearable pulsed electromagnetic fields"
51185|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51186|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51187|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51188|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51189|NCT01890122|E4|Reported Event|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51190|NCT01890122|E3|Reported Event|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
51191|NCT01890122|E2|Reported Event|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
51192|NCT01890122|E1|Reported Event|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
51193|NCT01890031|B6|Baseline|Total|Total of all reporting groups
51194|NCT01890031|B5|Baseline|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
51195|NCT01890031|B4|Baseline|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51196|NCT01890031|B3|Baseline|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51197|NCT01890031|B2|Baseline|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
51198|NCT01890031|B1|Baseline|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
51199|NCT01890031|P5|Participant Flow|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
51200|NCT01890031|P4|Participant Flow|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51201|NCT01890031|P3|Participant Flow|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51202|NCT01890031|P2|Participant Flow|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
51203|NCT01890031|P1|Participant Flow|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
51204|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
51205|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51206|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51207|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
51208|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
51209|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
51210|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51211|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51212|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
53493|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
51215|NCT01890031|E4|Reported Event|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51216|NCT01890031|E3|Reported Event|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
51217|NCT01890031|E2|Reported Event|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
51218|NCT01890031|E1|Reported Event|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
51219|NCT01889667|B4|Baseline|Total|Total of all reporting groups
51220|NCT01889667|B3|Baseline|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51221|NCT01889667|B2|Baseline|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
51222|NCT01889667|B1|Baseline|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
51223|NCT01889667|P3|Participant Flow|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51224|NCT01889667|P2|Participant Flow|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
51225|NCT01889667|P1|Participant Flow|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
51226|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51227|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
51228|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
51229|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51230|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
51231|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
51232|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51233|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
51234|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
51235|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51236|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
51237|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
51238|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51239|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
51240|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
51241|NCT01889667|E3|Reported Event|Placebo|"Oil Capsules~Placebo: Oil Capsules"
51242|NCT01889667|E2|Reported Event|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)"
51243|NCT01889667|E1|Reported Event|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)"
51244|NCT01889563|B3|Baseline|Total|Total of all reporting groups
51245|NCT01889563|B2|Baseline|No Physical Exercise Training Program|No Physical Exercise Training Program
51246|NCT01889563|B1|Baseline|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
51247|NCT01889563|P2|Participant Flow|No Physical Exercise Training Program|No Physical Exercise Training Program
51248|NCT01889563|P1|Participant Flow|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
51249|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
51250|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
51251|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
51252|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
51253|NCT01889563|E2|Reported Event|No Physical Exercise Training Program|No Physical Exercise Training Program
51254|NCT01889563|E1|Reported Event|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
51255|NCT01889420|B1|Baseline|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51256|NCT01889420|P1|Participant Flow|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51257|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51258|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51259|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51260|NCT01889420|E1|Reported Event|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
51261|NCT01889251|B3|Baseline|Total|Total of all reporting groups
51262|NCT01889251|B2|Baseline|Sham Injection|Single sham injection to the study eye at baseline
51263|NCT01889251|B1|Baseline|Ocriplasmin|Single intravitreal injection to the study eye at baseline
51264|NCT01889251|P2|Participant Flow|Sham Injection|Single sham injection to the study eye at baseline
51265|NCT01889251|P1|Participant Flow|Ocriplasmin|Single intravitreal injection to the study eye at baseline
51266|NCT01889251|O2|Outcome|Sham Injection|Single sham injection to the study eye at baseline
51267|NCT01889251|O1|Outcome|Ocriplasmin|Single intravitreal injection to the study eye at baseline
51268|NCT01889251|E2|Reported Event|Sham Injection|Single sham injection to the study eye at baseline
51269|NCT01889251|E1|Reported Event|Ocriplasmin|Single intravitreal injection to the study eye at baseline
51270|NCT01888965|B1|Baseline|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51271|NCT01888965|P1|Participant Flow|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51272|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51273|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51312|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51274|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51275|NCT01888965|E1|Reported Event|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
51276|NCT01888900|B3|Baseline|Total|Total of all reporting groups
51277|NCT01888900|B2|Baseline|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51278|NCT01888900|B1|Baseline|Hepatitis C Virus Genotype 1A|subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51279|NCT01888900|P2|Participant Flow|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51280|NCT01888900|P1|Participant Flow|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51281|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51282|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51283|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51284|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51285|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51286|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51287|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51288|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51289|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51290|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51291|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51292|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51293|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51294|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51295|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
51296|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
51297|NCT01888900|E2|Reported Event|Hepatitis C Virus Genotype 1B|"subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.~Asunaprevir and Daclatsvir"
51298|NCT01888900|E1|Reported Event|Hepatitis C Virus Genotype 1A|"Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.~Asunaprevir, daclatsvir, peginterferon, ribavirin"
51299|NCT01888367|B4|Baseline|Total|Total of all reporting groups
51300|NCT01888367|B3|Baseline|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51301|NCT01888367|B2|Baseline|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51302|NCT01888367|B1|Baseline|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51303|NCT01888367|P3|Participant Flow|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51304|NCT01888367|P2|Participant Flow|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51305|NCT01888367|P1|Participant Flow|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51306|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51307|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51308|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51309|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51310|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51311|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51313|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51314|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51315|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51316|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51317|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51318|NCT01888367|E3|Reported Event|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
51319|NCT01888367|E2|Reported Event|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
51320|NCT01888367|E1|Reported Event|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
51321|NCT01888003|B4|Baseline|Total|Total of all reporting groups
51322|NCT01888003|B3|Baseline|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51323|NCT01888003|B2|Baseline|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51324|NCT01888003|B1|Baseline|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51325|NCT01888003|P3|Participant Flow|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51326|NCT01888003|P2|Participant Flow|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51327|NCT01888003|P1|Participant Flow|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51350|NCT01887990|P2|Participant Flow|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51351|NCT01887990|P1|Participant Flow|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use~Ketamine"
51328|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51329|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51330|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51331|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51332|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51333|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51334|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51335|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51352|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|suicidal patients who use opioids who received saline infusion or placebo
51353|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal pts who have used opioids, in the ketamine treatment arm
51354|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51355|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51336|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51337|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51338|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51339|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
51340|NCT01888003|E3|Reported Event|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51341|NCT01888003|E2|Reported Event|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
51342|NCT01888003|E1|Reported Event|Anemia Treatment Group (AMG)|"Patients diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days, −7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery"
51343|NCT01887990|B5|Baseline|Total|Total of all reporting groups
51344|NCT01887990|B4|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51345|NCT01887990|B3|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51346|NCT01887990|B2|Baseline|Suicidal, Depression With Saline|"suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51347|NCT01887990|B1|Baseline|Suicidal, Depression With Ketamine|"suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51348|NCT01887990|P4|Participant Flow|Suicidal, Depression With Opioid Use With Saline|suicidal, depression with opioid use, given saline IV
51349|NCT01887990|P3|Participant Flow|Suicidal, Depression and Opioid Use With Ketamine|suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion
51356|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
51357|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
51358|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51359|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51360|NCT01887990|E4|Reported Event|Suicidal, Depression and Opioid With Saline|"Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51361|NCT01887990|E3|Reported Event|Suicidal, Depression and Opioid Use With Ketamine|"Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51362|NCT01887990|E2|Reported Event|Suicidal, Depression With Saline|"Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
51363|NCT01887990|E1|Reported Event|Suicidal, Depression With Ketamine|"Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
51364|NCT01887678|B3|Baseline|Total|Total of all reporting groups
51365|NCT01887678|B2|Baseline|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51366|NCT01887678|B1|Baseline|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51367|NCT01887678|P2|Participant Flow|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51368|NCT01887678|P1|Participant Flow|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51369|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51370|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51371|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51372|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51373|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51374|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51375|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51440|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
53494|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
51376|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51377|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51378|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51379|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51380|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51381|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51382|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51383|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51384|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51385|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51386|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51387|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51388|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51389|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51390|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51391|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51392|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51393|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51394|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51395|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51396|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51397|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51398|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51399|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51400|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51401|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51402|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51403|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51404|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51405|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51406|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51407|NCT01887678|E2|Reported Event|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51408|NCT01887678|E1|Reported Event|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
51409|NCT01887470|B5|Baseline|Total|Total of all reporting groups
51410|NCT01887470|B4|Baseline|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
51411|NCT01887470|B3|Baseline|Split Dose Preparation; AM Colonscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
51412|NCT01887470|B2|Baseline|Full Dose Preparation: PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
51413|NCT01887470|B1|Baseline|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
51414|NCT01887470|P4|Participant Flow|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
51415|NCT01887470|P3|Participant Flow|Split Dose Preparation; AM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
51416|NCT01887470|P2|Participant Flow|Full Dose Preparation; PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
51417|NCT01887470|P1|Participant Flow|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
51418|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51419|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51420|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51421|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51422|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
51423|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51424|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51425|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
51426|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
51427|NCT01887470|O4|Outcome|Regimen B for PM Colonoscopy|"Regimen B for afternoon colonoscopy~Regimen B"
51428|NCT01887470|O3|Outcome|Regimen B for AM Colonoscopy|"Regimen B for morning colonoscopy~Regimen B"
51429|NCT01887470|O2|Outcome|Regimen A for PM Colonoscopy|"Regimen A for afternoon colonoscopy~Regimen A"
51430|NCT01887470|O1|Outcome|Regimen A for AM Colonoscopy|"Regimen A for morning colonoscopy~Regimen A"
51431|NCT01887470|E1|Reported Event|Lactulose for Oral Solution|All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy.
51432|NCT01887418|B4|Baseline|Total|Total of all reporting groups
51433|NCT01887418|B3|Baseline|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
51434|NCT01887418|B2|Baseline|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
51435|NCT01887418|B1|Baseline|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
51436|NCT01887418|P3|Participant Flow|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
51437|NCT01887418|P2|Participant Flow|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
51438|NCT01887418|P1|Participant Flow|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
51439|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
51494|NCT01886716|B5|Baseline|Total|Total of all reporting groups
102086|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
51441|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
51442|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
51443|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
51444|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
51445|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
51446|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
51447|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
51448|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
51449|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
51450|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
51451|NCT01887418|E3|Reported Event|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
51452|NCT01887418|E2|Reported Event|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
51453|NCT01887418|E1|Reported Event|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
51454|NCT01887353|B3|Baseline|Total|Total of all reporting groups
51455|NCT01887353|B2|Baseline|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
51456|NCT01887353|B1|Baseline|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
51457|NCT01887353|P2|Participant Flow|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
51458|NCT01887353|P1|Participant Flow|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
51459|NCT01887353|O2|Outcome|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
51460|NCT01887353|O1|Outcome|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
51461|NCT01887353|E2|Reported Event|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
51462|NCT01887353|E1|Reported Event|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
51463|NCT01886963|B3|Baseline|Total|Total of all reporting groups
51464|NCT01886963|B2|Baseline|SPY - Unblinded Use of SPY Elite|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
51465|NCT01886963|B1|Baseline|Control - Blinded Use of SPY Elite|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
51466|NCT01886963|P2|Participant Flow|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
51495|NCT01886716|B4|Baseline|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
102087|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
51467|NCT01886963|P1|Participant Flow|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
51468|NCT01886963|O2|Outcome|Group B|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
51469|NCT01886963|O1|Outcome|Group A|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
51470|NCT01886963|E2|Reported Event|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
51471|NCT01886963|E1|Reported Event|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
51472|NCT01886807|B4|Baseline|Total|Total of all reporting groups
51473|NCT01886807|B3|Baseline|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
51474|NCT01886807|B2|Baseline|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
51475|NCT01886807|B1|Baseline|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
51476|NCT01886807|P3|Participant Flow|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
51477|NCT01886807|P2|Participant Flow|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
51478|NCT01886807|P1|Participant Flow|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
51479|NCT01886807|O3|Outcome|(VL Group)|"nasotracheal intubation using the Truview PCD video laryngoscope~TrueView PCD Video Laryngoscope"
51480|NCT01886807|O2|Outcome|(DL-O2 Group)|"direct laryngoscopy for nasotracheal intubation with oxygen insufflation~TrueView PCD Video Laryngoscope"
51481|NCT01886807|O1|Outcome|(DL Group)|"direct laryngoscopy for nasotracheal intubation without oxygen insufflation~TrueView PCD Video Laryngoscope"
51482|NCT01886807|E3|Reported Event|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
51483|NCT01886807|E2|Reported Event|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
51484|NCT01886807|E1|Reported Event|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
51485|NCT01886781|B3|Baseline|Total|Total of all reporting groups
51486|NCT01886781|B2|Baseline|Placebo|Controls Crytalline cellulose powder
51487|NCT01886781|B1|Baseline|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
51488|NCT01886781|P2|Participant Flow|Placebo|Controls Crytalline cellulose powder
51489|NCT01886781|P1|Participant Flow|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
51490|NCT01886781|O2|Outcome|Placebo|Controls Crytalline cellulose powder
51491|NCT01886781|O1|Outcome|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
51492|NCT01886781|E2|Reported Event|Placebo|Controls Crytalline cellulose powder
51493|NCT01886781|E1|Reported Event|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
51496|NCT01886716|B3|Baseline|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51497|NCT01886716|B2|Baseline|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51498|NCT01886716|B1|Baseline|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
51499|NCT01886716|P4|Participant Flow|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
51500|NCT01886716|P3|Participant Flow|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51501|NCT01886716|P2|Participant Flow|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51502|NCT01886716|P1|Participant Flow|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
51503|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
51504|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51505|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51506|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
51507|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
51508|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51509|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51510|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
51511|NCT01886716|E4|Reported Event|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
51512|NCT01886716|E3|Reported Event|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51513|NCT01886716|E2|Reported Event|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
51514|NCT01886716|E1|Reported Event|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
51515|NCT01886690|B3|Baseline|Total|Total of all reporting groups
51516|NCT01886690|B2|Baseline|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51517|NCT01886690|B1|Baseline|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51518|NCT01886690|P2|Participant Flow|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51519|NCT01886690|P1|Participant Flow|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51520|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51649|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51521|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51522|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51523|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51524|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51525|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51526|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51527|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51528|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51529|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51530|NCT01886690|E2|Reported Event|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
51531|NCT01886690|E1|Reported Event|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
51532|NCT01886300|B1|Baseline|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51533|NCT01886300|P1|Participant Flow|Peginterferon Alfa-2a|Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included.
51534|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51535|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51536|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51537|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51538|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51539|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51540|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51541|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51542|NCT01886300|E1|Reported Event|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
51543|NCT01886287|B1|Baseline|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
51544|NCT01886287|P1|Participant Flow|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
51545|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
51546|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
51547|NCT01886287|E1|Reported Event|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
51548|NCT01885910|B1|Baseline|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51549|NCT01885910|P1|Participant Flow|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
51550|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51551|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51552|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51553|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51554|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51555|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51650|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51556|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51557|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51558|NCT01885910|O2|Outcome|Aczone/Doxy - Non Inflammatory|non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
51559|NCT01885910|O1|Outcome|Aczone/Doxy - Inflammatory|inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
51560|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
51561|NCT01885910|E1|Reported Event|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
51562|NCT01885871|B1|Baseline|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51563|NCT01885871|P1|Participant Flow|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51564|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51565|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51566|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51567|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51568|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51569|NCT01885871|E1|Reported Event|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
51570|NCT01885559|B3|Baseline|Total|Total of all reporting groups
51571|NCT01885559|B2|Baseline|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51572|NCT01885559|B1|Baseline|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51573|NCT01885559|P2|Participant Flow|ACE-I + Angiotensin Receptor Blocker (ARB)|"ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51574|NCT01885559|P1|Participant Flow|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51575|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51576|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51577|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51578|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51579|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51580|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51581|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51582|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51583|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51584|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51585|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51586|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51587|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51588|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51589|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51590|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51591|NCT01885559|E2|Reported Event|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51592|NCT01885559|E1|Reported Event|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
51593|NCT01885117|B3|Baseline|Total|Total of all reporting groups
51594|NCT01885117|B2|Baseline|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51595|NCT01885117|B1|Baseline|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51596|NCT01885117|P2|Participant Flow|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51597|NCT01885117|P1|Participant Flow|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51598|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51599|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51600|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51601|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51602|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51603|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51604|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51605|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51606|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51607|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51608|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51609|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51610|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51611|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51612|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51613|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51614|NCT01885117|E2|Reported Event|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51615|NCT01885117|E1|Reported Event|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
51616|NCT01885104|B3|Baseline|Total|Total of all reporting groups
51617|NCT01885104|B2|Baseline|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51618|NCT01885104|B1|Baseline|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51619|NCT01885104|P2|Participant Flow|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51620|NCT01885104|P1|Participant Flow|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51621|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51622|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51623|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51624|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51625|NCT01885104|E2|Reported Event|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51626|NCT01885104|E1|Reported Event|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
51627|NCT01885000|B3|Baseline|Total|Total of all reporting groups
51628|NCT01885000|B2|Baseline|Vehicle|once-daily brimonidine tartrate vehicle gel
51629|NCT01885000|B1|Baseline|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51630|NCT01885000|P2|Participant Flow|Vehicle|once-daily brimonidine tartrate vehicle gel
51631|NCT01885000|P1|Participant Flow|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51632|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
51633|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51634|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
51635|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51636|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
51637|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51638|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
51639|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51640|NCT01885000|E2|Reported Event|Vehicle|once-daily brimonidine tartrate vehicle gel
51641|NCT01885000|E1|Reported Event|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
51642|NCT01884675|B3|Baseline|Total|Total of all reporting groups
51643|NCT01884675|B2|Baseline|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51644|NCT01884675|B1|Baseline|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51645|NCT01884675|P2|Participant Flow|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51646|NCT01884675|P1|Participant Flow|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51647|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51648|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51651|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51652|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.c
51653|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51654|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51655|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51656|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51657|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51658|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51659|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51660|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51661|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51662|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51663|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51664|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51665|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51666|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51667|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51668|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51669|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51670|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51671|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51672|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51673|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51674|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51675|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51676|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51677|NCT01884675|O2|Outcome|Ambrisentan 5mg|Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
51678|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51679|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51680|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51681|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51682|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51683|NCT01884675|E2|Reported Event|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
51684|NCT01884675|E1|Reported Event|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
51685|NCT01884519|B3|Baseline|Total|Total of all reporting groups
51686|NCT01884519|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51687|NCT01884519|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51688|NCT01884519|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51689|NCT01884519|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51690|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51691|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51692|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51693|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51694|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51695|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51696|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51697|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51698|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51699|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51700|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51701|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51702|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51703|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccinationars Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51704|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51705|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51706|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51707|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51708|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51709|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51710|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51711|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51712|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51713|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51714|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51715|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51716|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51839|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51840|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51717|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51718|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51719|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51720|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51721|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51722|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51723|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51724|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51725|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51726|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51727|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51728|NCT01884519|E2|Reported Event|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51729|NCT01884519|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
51730|NCT01884064|B3|Baseline|Total|Total of all reporting groups
51731|NCT01884064|B2|Baseline|Sham rTMS|"Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~Sham rTMS: Sham rTMS"
51732|NCT01884064|B1|Baseline|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51733|NCT01884064|P2|Participant Flow|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51734|NCT01884064|P1|Participant Flow|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51735|NCT01884064|O2|Outcome|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51736|NCT01884064|O1|Outcome|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51737|NCT01884064|E2|Reported Event|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51738|NCT01884064|E1|Reported Event|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
51739|NCT01883999|B1|Baseline|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51740|NCT01883999|P1|Participant Flow|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51741|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51742|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51743|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51744|NCT01883999|E1|Reported Event|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
51745|NCT01883986|B3|Baseline|Total|Total of all reporting groups
51746|NCT01883986|B2|Baseline|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51747|NCT01883986|B1|Baseline|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51841|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51748|NCT01883986|P2|Participant Flow|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51749|NCT01883986|P1|Participant Flow|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51750|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51751|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51752|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51753|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51754|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51755|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51756|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51757|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51758|NCT01883986|E2|Reported Event|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
51759|NCT01883986|E1|Reported Event|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
51760|NCT01883908|B3|Baseline|Total|Total of all reporting groups
51761|NCT01883908|B2|Baseline|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51762|NCT01883908|B1|Baseline|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51763|NCT01883908|P2|Participant Flow|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51764|NCT01883908|P1|Participant Flow|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51765|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51766|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51767|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51768|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51769|NCT01883908|E2|Reported Event|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51770|NCT01883908|E1|Reported Event|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
51771|NCT01883635|B3|Baseline|Total|Total of all reporting groups
51772|NCT01883635|B2|Baseline|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51773|NCT01883635|B1|Baseline|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51774|NCT01883635|P2|Participant Flow|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51775|NCT01883635|P1|Participant Flow|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51776|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51777|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51778|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51779|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51780|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51781|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
51782|NCT01883635|E4|Reported Event|Dyadic Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
51783|NCT01883635|E3|Reported Event|Individual Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
51784|NCT01883635|E2|Reported Event|Dyadic Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
51785|NCT01883635|E1|Reported Event|Individual Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
51786|NCT01883453|B3|Baseline|Total|Total of all reporting groups
102088|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
51787|NCT01883453|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
51788|NCT01883453|B1|Baseline|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
51789|NCT01883453|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
51790|NCT01883453|P1|Participant Flow|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
51791|NCT01883453|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
51792|NCT01883453|O1|Outcome|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
51793|NCT01883453|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
51794|NCT01883453|E1|Reported Event|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
51795|NCT01883440|B3|Baseline|Total|Total of all reporting groups
51796|NCT01883440|B2|Baseline|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
51797|NCT01883440|B1|Baseline|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
51798|NCT01883440|P2|Participant Flow|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
51799|NCT01883440|P1|Participant Flow|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
51800|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
51801|NCT01883440|O1|Outcome|Saline+Glucose|A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
51802|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
51803|NCT01883440|O1|Outcome|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
51804|NCT01883440|E2|Reported Event|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
51805|NCT01883440|E1|Reported Event|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
51806|NCT01883427|B3|Baseline|Total|Total of all reporting groups
51807|NCT01883427|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
51808|NCT01883427|B1|Baseline|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
51842|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51843|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51844|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51809|NCT01883427|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
51810|NCT01883427|P1|Participant Flow|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
51811|NCT01883427|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
51812|NCT01883427|O1|Outcome|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
51813|NCT01883427|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
51814|NCT01883427|E1|Reported Event|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
51815|NCT01882907|B3|Baseline|Total|Total of all reporting groups
51816|NCT01882907|B2|Baseline|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
51817|NCT01882907|B1|Baseline|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
51818|NCT01882907|P2|Participant Flow|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
51819|NCT01882907|P1|Participant Flow|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
51820|NCT01882907|O2|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
51821|NCT01882907|O1|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
51822|NCT01882907|E2|Reported Event|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
51823|NCT01882907|E1|Reported Event|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
51824|NCT01882725|B1|Baseline|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
51825|NCT01882725|P1|Participant Flow|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
51826|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
51827|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
51828|NCT01882725|E1|Reported Event|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
51829|NCT01882647|B3|Baseline|Total|Total of all reporting groups
51830|NCT01882647|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51831|NCT01882647|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51832|NCT01882647|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51833|NCT01882647|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51834|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51835|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51836|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51837|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
51838|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
51849|NCT01882465|P7|Participant Flow|Not Assigned|Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
51850|NCT01882465|P6|Participant Flow|Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51851|NCT01882465|P5|Participant Flow|Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51852|NCT01882465|P4|Participant Flow|2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51853|NCT01882465|P3|Participant Flow|2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51854|NCT01882465|P2|Participant Flow|Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51855|NCT01882465|P1|Participant Flow|Etafilcon A/2-HEMA, EGDMA/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
51856|NCT01882465|O3|Outcome|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
51857|NCT01882465|O2|Outcome|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
51858|NCT01882465|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
51859|NCT01882465|E3|Reported Event|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
51860|NCT01882465|E2|Reported Event|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
51861|NCT01882465|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
51862|NCT01882413|B1|Baseline|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51863|NCT01882413|P1|Participant Flow|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51864|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51865|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51866|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51867|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51868|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51869|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51870|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51871|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51872|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51873|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51874|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51875|NCT01882413|E1|Reported Event|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
51876|NCT01882257|B4|Baseline|Total|Total of all reporting groups
51877|NCT01882257|B3|Baseline|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
54608|NCT01856322|P2|Participant Flow|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
51878|NCT01882257|B2|Baseline|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
51879|NCT01882257|B1|Baseline|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
51880|NCT01882257|P3|Participant Flow|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
51881|NCT01882257|P2|Participant Flow|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
51882|NCT01882257|P1|Participant Flow|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
51883|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because in determining the efficiency and reliability of home-based overnight testing, there is no difference between the three groups
51884|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
51885|NCT01882257|E3|Reported Event|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
51886|NCT01882257|E2|Reported Event|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
51887|NCT01882257|E1|Reported Event|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
51888|NCT01882062|B1|Baseline|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
51889|NCT01882062|P1|Participant Flow|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
51890|NCT01882062|O1|Outcome|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
51891|NCT01882062|E1|Reported Event|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
51892|NCT01881932|B4|Baseline|Total|Total of all reporting groups
51893|NCT01881932|B3|Baseline|Sham Acupuncture|"Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui"
51894|NCT01881932|B2|Baseline|Acupuncture|Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to the surface of the same points with adhesive tape, w
51895|NCT01881932|B1|Baseline|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
52040|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
53495|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
51896|NCT01881932|P3|Participant Flow|Sham Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape"
51897|NCT01881932|P2|Participant Flow|Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and"
51898|NCT01881932|P1|Participant Flow|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
51899|NCT01881932|O3|Outcome|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). Patients to get sham acupuncture til the end of their chemo & following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Pt complete a wkly questionnaire to determine severity of nerve pain symptoms. Each wk record the total amount of chemo in the past week & all together. Each wk patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device of a retractable needle & an adhesive tube into sham points &apply 2 pieces of adhesive tape next to needles; will tap a mock plastic needle guiding tube on surface of each of 8 true points in the arm & leg to produce some discernible sensation & then apply needle w/ piece of adhesive tape to dermal surface, w/out needle insertion.
51900|NCT01881932|O2|Outcome|Acupuncture|Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week & all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to surface of the same points with adhesive tape, no needle insertion.
51901|NCT01881932|O1|Outcome|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
51902|NCT01881932|E3|Reported Event|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week & all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle & adhesive tube into the sham points, & then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm & leg to produce sensation & apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
51903|NCT01881932|E2|Reported Event|Acupuncture|"Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points & affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
52041|NCT01880697|E2|Reported Event|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
51904|NCT01881932|E1|Reported Event|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
51905|NCT01881776|B4|Baseline|Total|Total of all reporting groups
51906|NCT01881776|B3|Baseline|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51907|NCT01881776|B2|Baseline|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51908|NCT01881776|B1|Baseline|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51909|NCT01881776|P3|Participant Flow|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51910|NCT01881776|P2|Participant Flow|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51911|NCT01881776|P1|Participant Flow|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51912|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51913|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51914|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51915|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51916|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51917|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51918|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
52183|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
51919|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51920|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51921|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51922|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51923|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51924|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51925|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51926|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51927|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51928|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51929|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51930|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51931|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
52042|NCT01880697|E1|Reported Event|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52043|NCT01880437|B4|Baseline|Total|Total of all reporting groups
51932|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51933|NCT01881776|E3|Reported Event|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
51934|NCT01881776|E2|Reported Event|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51935|NCT01881776|E1|Reported Event|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
51936|NCT01881126|B3|Baseline|Total|Total of all reporting groups
51937|NCT01881126|B2|Baseline|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
51938|NCT01881126|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
51939|NCT01881126|P2|Participant Flow|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
51940|NCT01881126|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
51941|NCT01881126|O2|Outcome|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
51942|NCT01881126|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
51943|NCT01881126|E2|Reported Event|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
51944|NCT01881126|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
51945|NCT01880840|B3|Baseline|Total|Total of all reporting groups
51946|NCT01880840|B2|Baseline|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
51947|NCT01880840|B1|Baseline|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
51948|NCT01880840|P2|Participant Flow|Astepro 0.1%|azelastine hydrochloride 548 mcg nasal spray
51949|NCT01880840|P1|Participant Flow|Astepro 0.15%|azelastine hydrochloride 822mcg nasal spray
51950|NCT01880840|O2|Outcome|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
51951|NCT01880840|O1|Outcome|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
51952|NCT01880840|E2|Reported Event|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
51953|NCT01880840|E1|Reported Event|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
51954|NCT01880736|B5|Baseline|Total|Total of all reporting groups
51955|NCT01880736|B4|Baseline|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
51956|NCT01880736|B3|Baseline|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
51957|NCT01880736|B2|Baseline|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
51958|NCT01880736|B1|Baseline|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
51959|NCT01880736|P4|Participant Flow|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
102089|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
51960|NCT01880736|P3|Participant Flow|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
51961|NCT01880736|P2|Participant Flow|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
51962|NCT01880736|P1|Participant Flow|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
51963|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51964|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51965|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51966|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51967|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51968|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51969|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51970|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
52044|NCT01880437|B3|Baseline|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
102090|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
51971|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51972|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51973|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51974|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51975|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51976|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51977|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51978|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51979|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51990|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
102091|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
51980|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51981|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51982|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51983|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51984|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51985|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51986|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51987|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51988|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51989|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
52036|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
51991|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51992|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51993|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51994|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51995|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51996|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51997|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
51998|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
51999|NCT01880736|E4|Reported Event|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
52037|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52038|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52039|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52000|NCT01880736|E3|Reported Event|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
52001|NCT01880736|E2|Reported Event|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
52002|NCT01880736|E1|Reported Event|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
52003|NCT01880723|B3|Baseline|Total|Total of all reporting groups
52004|NCT01880723|B2|Baseline|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52005|NCT01880723|B1|Baseline|Healthy|Healthy Control subjects
52006|NCT01880723|P2|Participant Flow|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52007|NCT01880723|P1|Participant Flow|Healthy|Healthy control subjects
52008|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52009|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
52010|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52011|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
52012|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52013|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
52014|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52015|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
52016|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52017|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
52018|NCT01880723|E2|Reported Event|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
52019|NCT01880723|E1|Reported Event|Healthy|Healthy control subjects
52020|NCT01880697|B3|Baseline|Total|Total of all reporting groups
52021|NCT01880697|B2|Baseline|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52022|NCT01880697|B1|Baseline|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52023|NCT01880697|P2|Participant Flow|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52024|NCT01880697|P1|Participant Flow|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52025|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52026|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52027|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52028|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52029|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52030|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52031|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52032|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52033|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52034|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
52035|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
102092|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
52045|NCT01880437|B2|Baseline|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52046|NCT01880437|B1|Baseline|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52047|NCT01880437|P3|Participant Flow|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52048|NCT01880437|P2|Participant Flow|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52049|NCT01880437|P1|Participant Flow|Poor Risk Cytogenetics|Participants with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory high-risk myelodysplastic syndrome (MDS) falling under 'poor risk cytogenetics' subgroup received oral 150 milligrams (mg) dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52050|NCT01880437|O1|Outcome|Planned Cohort 2|Participants in Cohort 2 were planned to receive low-dose subcutaneous injections of cytarabine in combination with continuous daily vismodegib (150 mg orally).
52051|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52052|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52053|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52054|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52055|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52056|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52057|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52058|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52059|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52060|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52061|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52062|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52063|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52064|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52065|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52066|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52067|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52068|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52069|NCT01880437|E3|Reported Event|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52070|NCT01880437|E2|Reported Event|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52071|NCT01880437|E1|Reported Event|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
52072|NCT01880424|B3|Baseline|Total|Total of all reporting groups
52073|NCT01880424|B2|Baseline|Placebo Arm|matching placebo capsules, oral, once daily
52074|NCT01880424|B1|Baseline|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52075|NCT01880424|P2|Participant Flow|Placebo Arm|matching placebo capsules, oral, once daily
52076|NCT01880424|P1|Participant Flow|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52077|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52078|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52079|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52080|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52081|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52082|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52083|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52084|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52085|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52086|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52087|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52088|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52089|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52090|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52091|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52092|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52093|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
52094|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52095|NCT01880424|E2|Reported Event|Placebo Arm|matching placebo capsules, oral, once daily
52096|NCT01880424|E1|Reported Event|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
52097|NCT01880320|B4|Baseline|Total|Total of all reporting groups
52098|NCT01880320|B3|Baseline|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
52099|NCT01880320|B2|Baseline|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
52100|NCT01880320|B1|Baseline|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
52101|NCT01880320|P3|Participant Flow|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
52102|NCT01880320|P2|Participant Flow|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
52103|NCT01880320|P1|Participant Flow|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
52104|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
52105|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
52106|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
52107|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
52108|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
52109|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
52110|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
102093|NCT01587079|O8|Outcome|GP MDI 18 μg (PT001)|18 μg
52117|NCT01879852|B2|Baseline|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52118|NCT01879852|B1|Baseline|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52119|NCT01879852|P2|Participant Flow|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52120|NCT01879852|P1|Participant Flow|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52121|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52122|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52123|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52124|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52125|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52126|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52127|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52128|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52184|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
54609|NCT01856322|P1|Participant Flow|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
52129|NCT01879852|E2|Reported Event|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52130|NCT01879852|E1|Reported Event|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
52131|NCT01879800|B3|Baseline|Total|Total of all reporting groups
52132|NCT01879800|B2|Baseline|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52133|NCT01879800|B1|Baseline|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52134|NCT01879800|P2|Participant Flow|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52135|NCT01879800|P1|Participant Flow|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52136|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52137|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52138|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52139|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52140|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52141|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52142|NCT01879800|E2|Reported Event|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
52143|NCT01879800|E1|Reported Event|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
52144|NCT01879735|B3|Baseline|Total|Total of all reporting groups
54610|NCT01856322|O2|Outcome|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
52145|NCT01879735|B2|Baseline|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
52146|NCT01879735|B1|Baseline|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
52147|NCT01879735|P2|Participant Flow|Bolus and Constant Infusion of 11C-CSar|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
52148|NCT01879735|P1|Participant Flow|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
52149|NCT01879735|O2|Outcome|Infusion Method|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
52150|NCT01879735|O1|Outcome|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
52151|NCT01879735|E2|Reported Event|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
52152|NCT01879735|E1|Reported Event|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
52153|NCT01879722|B11|Baseline|Total|Total of all reporting groups
52154|NCT01879722|B10|Baseline|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52155|NCT01879722|B9|Baseline|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52156|NCT01879722|B8|Baseline|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52157|NCT01879722|B7|Baseline|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52158|NCT01879722|B6|Baseline|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52159|NCT01879722|B5|Baseline|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52160|NCT01879722|B4|Baseline|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52161|NCT01879722|B3|Baseline|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52162|NCT01879722|B2|Baseline|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52163|NCT01879722|B1|Baseline|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
52164|NCT01879722|P10|Participant Flow|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52165|NCT01879722|P9|Participant Flow|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52166|NCT01879722|P8|Participant Flow|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52167|NCT01879722|P7|Participant Flow|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52168|NCT01879722|P6|Participant Flow|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52169|NCT01879722|P5|Participant Flow|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52170|NCT01879722|P4|Participant Flow|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52171|NCT01879722|P3|Participant Flow|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52172|NCT01879722|P2|Participant Flow|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52173|NCT01879722|P1|Participant Flow|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52174|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52175|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52176|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52177|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52178|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52179|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52180|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52181|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52182|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
102094|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
52185|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52186|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52187|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52188|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52189|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52190|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52191|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52192|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52193|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52194|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52195|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52196|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52197|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52198|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52199|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52200|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52201|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52202|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52203|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52204|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52205|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52206|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52207|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52208|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52209|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52210|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52211|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52212|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52213|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52214|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52215|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52216|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52217|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52218|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52219|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52220|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52221|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52222|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52223|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52224|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52225|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52226|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52227|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
54611|NCT01856322|O1|Outcome|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
52228|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52229|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52230|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52231|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52232|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52233|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52234|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52235|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52236|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52237|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52238|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52239|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52240|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52241|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52242|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52243|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52244|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52245|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52246|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52247|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52248|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52249|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52250|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52251|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52252|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52253|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52254|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52255|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52256|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52257|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52258|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52259|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52260|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52261|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52262|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52263|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52264|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52265|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52266|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52267|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52268|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52269|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52270|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
53496|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
52271|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52272|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52273|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52274|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52275|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52276|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52277|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52278|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52279|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52280|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52281|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52282|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52283|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52284|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52285|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52286|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52287|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52288|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52289|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52290|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52291|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52292|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52293|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52294|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52295|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52296|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52297|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52298|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52299|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52300|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52301|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52302|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52303|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52304|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52305|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52306|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52307|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52308|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52309|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52310|NCT01879722|E10|Reported Event|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
52311|NCT01879722|E9|Reported Event|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52312|NCT01879722|E8|Reported Event|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
52313|NCT01879722|E7|Reported Event|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
102095|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
52314|NCT01879722|E6|Reported Event|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52315|NCT01879722|E5|Reported Event|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52316|NCT01879722|E4|Reported Event|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52317|NCT01879722|E3|Reported Event|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52318|NCT01879722|E2|Reported Event|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52319|NCT01879722|E1|Reported Event|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
52320|NCT01879683|B1|Baseline|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52321|NCT01879683|P1|Participant Flow|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52322|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52323|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52324|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52325|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52326|NCT01879683|E1|Reported Event|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
52327|NCT01879618|B1|Baseline|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
52328|NCT01879618|P1|Participant Flow|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
52329|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
52330|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
52331|NCT01879618|E1|Reported Event|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
52332|NCT01879579|B3|Baseline|Total|Total of all reporting groups
52333|NCT01879579|B2|Baseline|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52334|NCT01879579|B1|Baseline|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52335|NCT01879579|P2|Participant Flow|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52336|NCT01879579|P1|Participant Flow|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52337|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
52338|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
52339|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52381|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52340|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52341|NCT01879579|O2|Outcome|Insulin Titration Visits in the Clinic|Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
52342|NCT01879579|O1|Outcome|Insulin Titration Visits by Phone|Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
52343|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52344|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52345|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52346|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52347|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52348|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52349|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52350|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52351|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52352|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52353|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52354|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52355|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52382|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52618|NCT01877720|P1|Participant Flow|PS-NAVA|"noninvasive PSV first for 15 minutes and then NAVA for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
52356|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52357|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52358|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52359|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52360|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52361|NCT01879579|E2|Reported Event|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
52362|NCT01879579|E1|Reported Event|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
52363|NCT01879553|B3|Baseline|Total|Total of all reporting groups
52364|NCT01879553|B2|Baseline|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52365|NCT01879553|B1|Baseline|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52366|NCT01879553|P2|Participant Flow|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52367|NCT01879553|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52368|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52369|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52370|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52371|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52372|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52373|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52374|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52375|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52376|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52377|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52378|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52379|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52380|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52383|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52384|NCT01879553|E3|Reported Event|Total|Total
52385|NCT01879553|E2|Reported Event|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52386|NCT01879553|E1|Reported Event|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
52387|NCT01879540|B1|Baseline|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52388|NCT01879540|P1|Participant Flow|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52389|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52390|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52391|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52392|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52393|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52394|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52395|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52396|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52397|NCT01879540|E1|Reported Event|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
52398|NCT01879410|B3|Baseline|Total|Total of all reporting groups
52399|NCT01879410|B2|Baseline|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
52400|NCT01879410|B1|Baseline|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
52401|NCT01879410|P2|Participant Flow|FSC 250/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
52402|NCT01879410|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks.
52403|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
52404|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
52405|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
52406|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
52407|NCT01879410|E2|Reported Event|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
52408|NCT01879410|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
52409|NCT01879371|B7|Baseline|Total|Total of all reporting groups
52410|NCT01879371|B6|Baseline|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52411|NCT01879371|B5|Baseline|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52412|NCT01879371|B4|Baseline|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52413|NCT01879371|B3|Baseline|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52414|NCT01879371|B2|Baseline|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52415|NCT01879371|B1|Baseline|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52416|NCT01879371|P6|Participant Flow|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52417|NCT01879371|P5|Participant Flow|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52418|NCT01879371|P4|Participant Flow|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52419|NCT01879371|P3|Participant Flow|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52420|NCT01879371|P2|Participant Flow|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52421|NCT01879371|P1|Participant Flow|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
52422|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52423|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52424|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52425|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52426|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52427|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52428|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52429|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52430|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52619|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52620|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52431|NCT01879371|E3|Reported Event|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52432|NCT01879371|E2|Reported Event|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52433|NCT01879371|E1|Reported Event|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
52434|NCT01879345|B4|Baseline|Total|Total of all reporting groups
52435|NCT01879345|B3|Baseline|Placebo|PLC, Placebo
52436|NCT01879345|B2|Baseline|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52437|NCT01879345|B1|Baseline|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52438|NCT01879345|P3|Participant Flow|Placebo|PLC, Placebo
52439|NCT01879345|P2|Participant Flow|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52440|NCT01879345|P1|Participant Flow|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52441|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52442|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52443|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52444|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52445|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg Oxcarbazepine is a BIA 2-093 metabolite
52446|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093 600 mg BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
52447|NCT01879345|O3|Outcome|Placebo|PLC, Placebo
52448|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52449|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52450|NCT01879345|E3|Reported Event|Placebo|PLC, Placebo
52451|NCT01879345|E2|Reported Event|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
52452|NCT01879345|E1|Reported Event|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
52453|NCT01879332|B4|Baseline|Total|Total of all reporting groups
52454|NCT01879332|B3|Baseline|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52455|NCT01879332|B2|Baseline|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52456|NCT01879332|B1|Baseline|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
52457|NCT01879332|P3|Participant Flow|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
52458|NCT01879332|P2|Participant Flow|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52459|NCT01879332|P1|Participant Flow|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52460|NCT01879332|O3|Outcome|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
52461|NCT01879332|O2|Outcome|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52462|NCT01879332|O1|Outcome|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52463|NCT01879332|E3|Reported Event|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
52464|NCT01879332|E2|Reported Event|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52465|NCT01879332|E1|Reported Event|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
52466|NCT01879319|B3|Baseline|Total|Total of all reporting groups
52467|NCT01879319|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
52468|NCT01879319|B1|Baseline|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
52469|NCT01879319|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
52621|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52622|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52470|NCT01879319|P1|Participant Flow|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
52471|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
52472|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
52473|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
52474|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
52475|NCT01879319|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
52476|NCT01879319|E1|Reported Event|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
52477|NCT01879176|B3|Baseline|Total|Total of all reporting groups
52478|NCT01879176|B2|Baseline|Control|No filter will be installed on the CPB machine.
52479|NCT01879176|B1|Baseline|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.
52480|NCT01879176|P2|Participant Flow|Control|No filter will be installed on the CPB machine.
52481|NCT01879176|P1|Participant Flow|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
52482|NCT01879176|O2|Outcome|Control|No filter will be installed on the CPB machine.
52483|NCT01879176|O1|Outcome|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
52484|NCT01879176|E2|Reported Event|Control|No filter will be installed on the CPB machine.
52485|NCT01879176|E1|Reported Event|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
52486|NCT01879059|B1|Baseline|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
52487|NCT01879059|P1|Participant Flow|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
52488|NCT01879059|O1|Outcome|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
52489|NCT01879059|E1|Reported Event|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
52490|NCT01878825|B3|Baseline|Total|Total of all reporting groups
52491|NCT01878825|B2|Baseline|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52492|NCT01878825|B1|Baseline|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52493|NCT01878825|P2|Participant Flow|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52494|NCT01878825|P1|Participant Flow|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52495|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52496|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52497|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52498|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52499|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52500|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52501|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52502|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52623|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52624|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52503|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52504|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52505|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52506|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52507|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52508|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52509|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52510|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52511|NCT01878825|O4|Outcome|Fluviral >60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52512|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52513|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52514|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52515|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52516|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52517|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52518|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
52519|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52520|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52521|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52522|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52523|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52524|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52525|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52526|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52559|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52527|NCT01878825|E2|Reported Event|Fluarix/Influsplit › 60 Years Group|Subjects aged › 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
52528|NCT01878825|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
52529|NCT01878812|B3|Baseline|Total|Total of all reporting groups
52530|NCT01878812|B2|Baseline|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52531|NCT01878812|B1|Baseline|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52532|NCT01878812|P2|Participant Flow|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52533|NCT01878812|P1|Participant Flow|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52534|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52535|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52536|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52537|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52538|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52539|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52540|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52541|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52542|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52543|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52544|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52545|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52546|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52547|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52548|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52549|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52550|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52551|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52552|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52553|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52554|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52555|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52556|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52557|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52558|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52625|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52626|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52560|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52561|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52562|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52563|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52564|NCT01878812|E2|Reported Event|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52565|NCT01878812|E1|Reported Event|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
52566|NCT01878799|B3|Baseline|Total|Total of all reporting groups
52567|NCT01878799|B2|Baseline|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52568|NCT01878799|B1|Baseline|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52569|NCT01878799|P2|Participant Flow|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52570|NCT01878799|P1|Participant Flow|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52571|NCT01878799|O2|Outcome|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52572|NCT01878799|O1|Outcome|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52573|NCT01878799|E2|Reported Event|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52574|NCT01878799|E1|Reported Event|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
52575|NCT01878656|B3|Baseline|Total|Total of all reporting groups
52576|NCT01878656|B2|Baseline|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
52577|NCT01878656|B1|Baseline|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
52578|NCT01878656|P2|Participant Flow|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
52579|NCT01878656|P1|Participant Flow|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
52580|NCT01878656|O2|Outcome|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
52581|NCT01878656|O1|Outcome|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
52617|NCT01877720|P2|Participant Flow|NAVA-PS|"noninvasive NAVA first for 15 minutes and then PSV for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
52627|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52628|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52582|NCT01878656|E2|Reported Event|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
52583|NCT01878656|E1|Reported Event|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
52584|NCT01878214|B3|Baseline|Total|Total of all reporting groups
52585|NCT01878214|B2|Baseline|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52586|NCT01878214|B1|Baseline|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52587|NCT01878214|P2|Participant Flow|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52588|NCT01878214|P1|Participant Flow|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52589|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52590|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52591|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52592|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52593|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52594|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52595|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52596|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52597|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52598|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52599|NCT01878214|E2|Reported Event|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
52600|NCT01878214|E1|Reported Event|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
52601|NCT01878149|B3|Baseline|Total|Total of all reporting groups
52602|NCT01878149|B2|Baseline|eXtreme Lumbar Interbody Fusion (XLIF®)|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
52603|NCT01878149|B1|Baseline|VEO® Lateral Access and Interbody Fusion System|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
52604|NCT01878149|P2|Participant Flow|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
52605|NCT01878149|P1|Participant Flow|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
52606|NCT01878149|O2|Outcome|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
52607|NCT01878149|O1|Outcome|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
52608|NCT01878149|E2|Reported Event|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
52609|NCT01878149|E1|Reported Event|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
52610|NCT01877941|B1|Baseline|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
52611|NCT01877941|P1|Participant Flow|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
52612|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
52613|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
52614|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
52615|NCT01877941|E1|Reported Event|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.~No adverse events."
52616|NCT01877720|B1|Baseline|Total Enrolled Patients|
52629|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
52630|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
52641|NCT01877538|B1|Baseline|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were recruited to this study."
52642|NCT01877538|P1|Participant Flow|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were scanned in this preliminary pilot study."
52643|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
52644|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
52645|NCT01877538|E1|Reported Event|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy controls were PET scanned in this preliminary study.~No adverse events were detected."
52646|NCT01877408|B3|Baseline|Total|Total of all reporting groups
52647|NCT01877408|B2|Baseline|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52648|NCT01877408|B1|Baseline|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52649|NCT01877408|P2|Participant Flow|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52650|NCT01877408|P1|Participant Flow|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52651|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52652|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52653|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52654|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52655|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52656|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52657|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52658|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52659|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52660|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52661|NCT01877408|O1|Outcome|Physicians|The generalist doctors in this study were moderately experienced in open surgical circumcision but had not previously used the Unicirc instruments.
52662|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52663|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52664|NCT01877408|E2|Reported Event|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
52665|NCT01877408|E1|Reported Event|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
52666|NCT01877343|B4|Baseline|Total|Total of all reporting groups
52667|NCT01877343|B3|Baseline|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52668|NCT01877343|B2|Baseline|Pediatric Heart Transplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52669|NCT01877343|B1|Baseline|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52670|NCT01877343|P7|Participant Flow|Adult Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52671|NCT01877343|P6|Participant Flow|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52672|NCT01877343|P5|Participant Flow|Pediatric Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52673|NCT01877343|P4|Participant Flow|Adult Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52674|NCT01877343|P3|Participant Flow|Adult Heart Failure|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52675|NCT01877343|P2|Participant Flow|Pediatric Heart Tansplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52676|NCT01877343|P1|Participant Flow|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52677|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52678|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52679|NCT01877343|E1|Reported Event|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
52680|NCT01877278|B3|Baseline|Total|Total of all reporting groups
52681|NCT01877278|B2|Baseline|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
52682|NCT01877278|B1|Baseline|Active|"emitting group~Wearable pulsed electromagnetic fields"
52691|NCT01877161|B1|Baseline|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.~3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus~The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
52692|NCT01877161|P1|Participant Flow|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.~different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
52693|NCT01877161|O3|Outcome|Sham rTMS|The coil was placed perpendicularly to the scalp during sham rTMS sessions.
52694|NCT01877161|O2|Outcome|rTMS Over STG|Repetitive magnetic stimulation (rTMS) were applied over STG
52695|NCT01877161|O1|Outcome|rTMS Over MTG|Repetitive magnetic stimulation (rTMS) were applied over MTG
52696|NCT01877161|E3|Reported Event|Superior Temporal Gyrus|"Repetitive magnetic stimulation to superior temporal gyrus~Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus"
52697|NCT01877161|E2|Reported Event|Control Group|"Repetitive magnetic stimulation (Sham)~Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)"
52698|NCT01877161|E1|Reported Event|Middle Temporal Gyrus|"Repetitive magnetic stimulation to middle temporal gyrus~Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus"
52699|NCT01877148|B3|Baseline|Total|Total of all reporting groups
52700|NCT01877148|B2|Baseline|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52701|NCT01877148|B1|Baseline|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52702|NCT01877148|P2|Participant Flow|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52703|NCT01877148|P1|Participant Flow|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52704|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52705|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52706|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52707|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52708|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52709|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52710|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52711|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52712|NCT01877148|E2|Reported Event|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52713|NCT01877148|E1|Reported Event|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
52714|NCT01876823|B1|Baseline|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52715|NCT01876823|P1|Participant Flow|Es-citalopram and Memantine Treatment|This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
52716|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52717|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52718|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52719|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52720|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52721|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52722|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52723|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52724|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52725|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52726|NCT01876823|E1|Reported Event|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
52727|NCT01876732|B1|Baseline|Vitamin B12|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
52728|NCT01876732|P1|Participant Flow|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
52729|NCT01876732|O1|Outcome|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
52772|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52730|NCT01876732|O1|Outcome|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
52731|NCT01876732|E1|Reported Event|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
52732|NCT01876706|B1|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure
52733|NCT01876706|P1|Participant Flow|UroLift Arm|Subjects that undergo the UroLift System procedure
52734|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52735|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52736|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52737|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52738|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52739|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52740|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52741|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52742|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52743|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52744|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52745|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52746|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52747|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
52748|NCT01876706|E1|Reported Event|UroLift Arm|Subjects that undergo the UroLift System procedure
52749|NCT01876368|B3|Baseline|Total|Total of all reporting groups
52750|NCT01876368|B2|Baseline|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52751|NCT01876368|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52752|NCT01876368|P2|Participant Flow|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52753|NCT01876368|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52754|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52755|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52756|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52757|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52758|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52759|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52760|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52761|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52762|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52763|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52764|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52765|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52766|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52767|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52768|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52769|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52770|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52771|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52773|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52774|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52775|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52776|NCT01876368|E2|Reported Event|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
52777|NCT01876368|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
52778|NCT01876329|B4|Baseline|Total|Total of all reporting groups
52779|NCT01876329|B3|Baseline|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
52780|NCT01876329|B2|Baseline|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
52781|NCT01876329|B1|Baseline|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
52782|NCT01876329|P3|Participant Flow|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
52783|NCT01876329|P2|Participant Flow|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
52784|NCT01876329|P1|Participant Flow|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
52785|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
52786|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
52787|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
52788|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
52789|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
52790|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
52791|NCT01876329|E3|Reported Event|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
52792|NCT01876329|E2|Reported Event|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
52793|NCT01876329|E1|Reported Event|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
52794|NCT01875991|B3|Baseline|Total|Total of all reporting groups
52795|NCT01875991|B2|Baseline|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
52796|NCT01875991|B1|Baseline|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
52797|NCT01875991|P2|Participant Flow|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
52798|NCT01875991|P1|Participant Flow|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
52799|NCT01875991|O2|Outcome|Autoinjector B Preference|Participants who preferred Autoinjector B overall
52800|NCT01875991|O1|Outcome|Autoinjector A Preference|Participants who preferred Autoinjector A overall
52801|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52802|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52803|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52804|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52805|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52806|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52807|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52808|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52809|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52810|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52811|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52812|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52813|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52814|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52815|NCT01875991|O1|Outcome|Primary Analysis Set|Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
52816|NCT01875991|E2|Reported Event|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
52817|NCT01875991|E1|Reported Event|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
52818|NCT01875978|B3|Baseline|Total|Total of all reporting groups
52819|NCT01875978|B2|Baseline|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
52820|NCT01875978|B1|Baseline|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
52821|NCT01875978|P2|Participant Flow|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
52822|NCT01875978|P1|Participant Flow|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
52823|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
52824|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
52825|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
52826|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
52827|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
52828|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
52829|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
52830|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
52831|NCT01875978|E2|Reported Event|Group B: Placebo-phytosterols|placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
52832|NCT01875978|E1|Reported Event|Group A: Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
52833|NCT01875848|B3|Baseline|Total|Total of all reporting groups
52834|NCT01875848|B2|Baseline|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
52835|NCT01875848|B1|Baseline|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
52836|NCT01875848|P2|Participant Flow|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
52837|NCT01875848|P1|Participant Flow|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
52838|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
52839|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
52840|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
52841|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
52842|NCT01875848|E2|Reported Event|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
52843|NCT01875848|E1|Reported Event|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
52844|NCT01875731|B3|Baseline|Total|Total of all reporting groups
52845|NCT01875731|B2|Baseline|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
52846|NCT01875731|B1|Baseline|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
52847|NCT01875731|P2|Participant Flow|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
52848|NCT01875731|P1|Participant Flow|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
52849|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
52850|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
52851|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
52852|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
52853|NCT01875731|E2|Reported Event|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
52854|NCT01875731|E1|Reported Event|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
52855|NCT01874665|B3|Baseline|Total|Total of all reporting groups
52856|NCT01874665|B2|Baseline|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
52857|NCT01874665|B1|Baseline|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
52858|NCT01874665|P2|Participant Flow|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
52859|NCT01874665|P1|Participant Flow|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
52860|NCT01874665|O1|Outcome|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
52861|NCT01874665|O1|Outcome|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
52862|NCT01874665|E1|Reported Event|Cohorts A & B|All patients with GIST (with and without) KIT exon 11 mutations
52863|NCT01875510|B3|Baseline|Total|Total of all reporting groups
52864|NCT01875510|B2|Baseline|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
52865|NCT01875510|B1|Baseline|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
52866|NCT01875510|P2|Participant Flow|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
52867|NCT01875510|P1|Participant Flow|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
52868|NCT01875510|O2|Outcome|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
52869|NCT01875510|O1|Outcome|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
52870|NCT01875510|E2|Reported Event|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
52871|NCT01875510|E1|Reported Event|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
52872|NCT01875471|B3|Baseline|Total|Total of all reporting groups
52873|NCT01875471|B2|Baseline|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
52874|NCT01875471|B1|Baseline|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
52875|NCT01875471|P2|Participant Flow|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
52876|NCT01875471|P1|Participant Flow|Delefilcon A|Spherical daily disposable soft contact lens
52877|NCT01875471|O2|Outcome|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
52878|NCT01875471|O1|Outcome|Delefilcon A|Spherical daily disposable soft contact lens
52879|NCT01875471|E2|Reported Event|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
52880|NCT01875471|E1|Reported Event|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
52881|NCT01875159|B3|Baseline|Total|Total of all reporting groups
52882|NCT01875159|B2|Baseline|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
52883|NCT01875159|B1|Baseline|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
52884|NCT01875159|P2|Participant Flow|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
52885|NCT01875159|P1|Participant Flow|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
52886|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
52887|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
52888|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
52889|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
52890|NCT01875159|E2|Reported Event|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
52891|NCT01875159|E1|Reported Event|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
52892|NCT01874340|B5|Baseline|Total|Total of all reporting groups
52893|NCT01874340|B4|Baseline|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52894|NCT01874340|B3|Baseline|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52895|NCT01874340|B2|Baseline|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52896|NCT01874340|B1|Baseline|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52897|NCT01874340|P4|Participant Flow|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52898|NCT01874340|P3|Participant Flow|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
55142|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
52899|NCT01874340|P2|Participant Flow|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52900|NCT01874340|P1|Participant Flow|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52901|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52902|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52903|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52904|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52905|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52906|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52907|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52908|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52909|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52910|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52911|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52912|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52913|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52914|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52915|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52916|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52917|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52918|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52919|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52920|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52921|NCT01874340|E4|Reported Event|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52922|NCT01874340|E3|Reported Event|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52923|NCT01874340|E2|Reported Event|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52924|NCT01874340|E1|Reported Event|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
52925|NCT01874275|B3|Baseline|Total|Total of all reporting groups
52926|NCT01874275|B2|Baseline|Device Sham|placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
52927|NCT01874275|B1|Baseline|VECTTOR - Active|nerve stimulator treatment twice daily for duration of study - 365 days ...
52928|NCT01874275|P2|Participant Flow|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
52929|NCT01874275|P1|Participant Flow|VECTTOR|"muscle stimulator treatment twice daily for duration of study - 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
52930|NCT01874275|O1|Outcome|VECTTOR|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
52931|NCT01874275|O1|Outcome|VECTTOR|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
52956|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52932|NCT01874275|O2|Outcome|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
52933|NCT01874275|O1|Outcome|VECTTOR|"nerve stimulator treatment twice daily for duration of study - 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
52934|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
52935|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study
52936|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
52937|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study - assessed at 180 days
52938|NCT01874275|E2|Reported Event|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
52939|NCT01874275|E1|Reported Event|VECTTOR|nerve stimulator treatment twice daily for duration of study - 365 days ...
52940|NCT01874262|B3|Baseline|Total|Total of all reporting groups
52941|NCT01874262|B2|Baseline|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
52942|NCT01874262|B1|Baseline|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
52943|NCT01874262|P2|Participant Flow|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
52944|NCT01874262|P1|Participant Flow|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
52945|NCT01874262|O2|Outcome|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
52946|NCT01874262|O1|Outcome|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
52947|NCT01874262|E2|Reported Event|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
52948|NCT01874262|E1|Reported Event|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
52949|NCT01874145|B3|Baseline|Total|Total of all reporting groups
52950|NCT01874145|B2|Baseline|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52951|NCT01874145|B1|Baseline|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52952|NCT01874145|P2|Participant Flow|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52953|NCT01874145|P1|Participant Flow|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52954|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52955|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
56000|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
52957|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52958|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52959|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52960|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52961|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52962|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52963|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52964|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52965|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52966|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52967|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52968|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52969|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52970|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52971|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52972|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52973|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52974|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52975|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52976|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52977|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52978|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52979|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52980|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52981|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52982|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
52983|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
52984|NCT01874145|E4|Reported Event|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
52985|NCT01874145|E3|Reported Event|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
52986|NCT01874145|E2|Reported Event|GA 40 mg/mL TIW (Core)|Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
52987|NCT01874145|E1|Reported Event|GA 20 mg/mL QD (Core)|Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
52988|NCT01874132|B4|Baseline|Total|Total of all reporting groups
52989|NCT01874132|B3|Baseline|Control|Non-exercising control group
52990|NCT01874132|B2|Baseline|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52991|NCT01874132|B1|Baseline|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52992|NCT01874132|P3|Participant Flow|Control|Non-exercising control group
52993|NCT01874132|P2|Participant Flow|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52994|NCT01874132|P1|Participant Flow|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52995|NCT01874132|O3|Outcome|Control|Non-exercising control group
52996|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52997|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
52998|NCT01874132|E3|Reported Event|Control|Non-exercising control group
52999|NCT01874132|E2|Reported Event|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
53000|NCT01874132|E1|Reported Event|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
53001|NCT01873950|B1|Baseline|All Study Participants|Participants who were randomized to receive either ranolazine, dofetilide, verapamil, quinidine or placebo.
53002|NCT01873950|P5|Participant Flow|Placebo|Single oral dose of Placebo (comparison group). Each subject received each drug only once in a randomized sequence (10 sequences in total).
53003|NCT01873950|P4|Participant Flow|Quinidine Sulfate 400 mg|Single oral dose of Quinidine sulfate 400mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
53004|NCT01873950|P3|Participant Flow|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
53005|NCT01873950|P2|Participant Flow|Dofetilide 500 mcg|Single oral dose of Dofetilide 500mcg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
53006|NCT01873950|P1|Participant Flow|Ranolazine 1500 mg|Single oral dose of Ranolazine 1500mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
53007|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
53008|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
53009|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
53010|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
53011|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
53012|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
53013|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
53014|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
53015|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
53016|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
53017|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
53018|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
53019|NCT01873950|E5|Reported Event|Placebo|Single oral dose of Placebo (comparison group)
53020|NCT01873950|E4|Reported Event|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
53021|NCT01873950|E3|Reported Event|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
53022|NCT01873950|E2|Reported Event|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
53023|NCT01873950|E1|Reported Event|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
53024|NCT01873859|B3|Baseline|Total|Total of all reporting groups
53025|NCT01873859|B2|Baseline|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
53026|NCT01873859|B1|Baseline|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
53027|NCT01873859|P2|Participant Flow|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
53028|NCT01873859|P1|Participant Flow|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
53029|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
53030|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: rise of creatinin 48 hr after recieving contrast media."
53031|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
53032|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
53033|NCT01873859|E2|Reported Event|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
53034|NCT01873859|E1|Reported Event|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
53035|NCT01873729|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
53036|NCT01873729|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
53037|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
53038|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
53039|NCT01873729|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
53040|NCT01873417|B1|Baseline|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53041|NCT01873417|P1|Participant Flow|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53042|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53043|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53044|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53045|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53046|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53047|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53048|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53049|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53050|NCT01873417|E1|Reported Event|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
53051|NCT01872715|B1|Baseline|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
53052|NCT01872715|P1|Participant Flow|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
53053|NCT01872715|O5|Outcome|Very Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53054|NCT01872715|O4|Outcome|Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53055|NCT01872715|O3|Outcome|Neither Satisfied Nor Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53056|NCT01872715|O2|Outcome|Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53057|NCT01872715|O1|Outcome|Very Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53058|NCT01872715|O5|Outcome|4 = Severe|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53497|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53059|NCT01872715|O4|Outcome|3 = Moderate|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53060|NCT01872715|O3|Outcome|2 = Mild|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53061|NCT01872715|O2|Outcome|1 = Near Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53062|NCT01872715|O1|Outcome|0 = Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
53063|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
53064|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
53065|NCT01872715|E1|Reported Event|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
53066|NCT01872611|B3|Baseline|Total|Total of all reporting groups
53067|NCT01872611|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53068|NCT01872611|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53069|NCT01872611|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53070|NCT01872611|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53071|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53072|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53073|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53074|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53075|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53076|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53077|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53078|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53079|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53080|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53081|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53082|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53083|NCT01872611|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
53084|NCT01872611|E3|Reported Event|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
53085|NCT01872611|E2|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
53086|NCT01872611|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
53087|NCT01872078|B5|Baseline|Total|Total of all reporting groups
53088|NCT01872078|B4|Baseline|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
53089|NCT01872078|B3|Baseline|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
53090|NCT01872078|B2|Baseline|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
53091|NCT01872078|B1|Baseline|Placebo|Two matching placebo tablets for both the morning and evening doses
53092|NCT01872078|P4|Participant Flow|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
53093|NCT01872078|P3|Participant Flow|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
53094|NCT01872078|P2|Participant Flow|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
53095|NCT01872078|P1|Participant Flow|Placebo|Two matching placebo tablets for both the morning and evening doses
53096|NCT01872078|O4|Outcome|40 mg AZD4901 Bid|40 mg AZD4901 twice daily administered orally
53097|NCT01872078|O3|Outcome|20 mg AZD4901 Bid|20 mg AZD4901 twice daily administered orally
53098|NCT01872078|O2|Outcome|20 mg AZD4901 qd|20 mg AZD4901 once daily administered orally
53099|NCT01872078|O1|Outcome|Placebo|Two matching placebo tablets for both the morning and evening doses
53100|NCT01872078|E4|Reported Event|Placebo|Two matching placebo tablets for both the morning and evening doses
53101|NCT01872078|E3|Reported Event|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
53102|NCT01872078|E2|Reported Event|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
53103|NCT01872078|E1|Reported Event|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
53104|NCT01871870|B1|Baseline|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
53123|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53105|NCT01871870|P1|Participant Flow|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
53106|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
53107|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
53108|NCT01871870|E1|Reported Event|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
53109|NCT01871805|B7|Baseline|Total|Total of all reporting groups
53110|NCT01871805|B6|Baseline|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53111|NCT01871805|B5|Baseline|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53112|NCT01871805|B4|Baseline|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53113|NCT01871805|B3|Baseline|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53114|NCT01871805|B2|Baseline|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53115|NCT01871805|B1|Baseline|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53116|NCT01871805|P6|Participant Flow|Alectinib 600 mg (Fed): Phase II|Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53117|NCT01871805|P5|Participant Flow|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53118|NCT01871805|P4|Participant Flow|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53119|NCT01871805|P3|Participant Flow|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53120|NCT01871805|P2|Participant Flow|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53121|NCT01871805|P1|Participant Flow|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53122|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
56281|NCT01846299|E2|Reported Event|Sham With Ranibizumab 0.5mg|Sham with Ranibizumab 0.5mg
53124|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53125|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53126|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53127|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53128|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53129|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53130|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53131|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53132|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53133|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53134|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53135|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53136|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53137|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53138|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53139|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53140|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53141|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53142|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53143|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53144|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53145|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53146|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53199|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53147|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53148|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53149|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53150|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53151|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53152|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53153|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53154|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53155|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53156|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53157|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53158|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53159|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53160|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53161|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53162|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53163|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53164|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53165|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53166|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53167|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53168|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53169|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53170|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53171|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53172|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
56282|NCT01846299|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
53173|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53174|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53175|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53176|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53177|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53178|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53179|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53180|NCT01871805|E6|Reported Event|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53181|NCT01871805|E5|Reported Event|Alectinib 900 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53182|NCT01871805|E4|Reported Event|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53183|NCT01871805|E3|Reported Event|Alectinib 600 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53184|NCT01871805|E2|Reported Event|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53185|NCT01871805|E1|Reported Event|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
53186|NCT01871558|B3|Baseline|Total|Total of all reporting groups
53187|NCT01871558|B2|Baseline|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53188|NCT01871558|B1|Baseline|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53189|NCT01871558|P2|Participant Flow|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53190|NCT01871558|P1|Participant Flow|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53191|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53192|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53193|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53194|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53195|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53196|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53197|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53198|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53498|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53499|NCT01869686|E1|Reported Event|Denosumab 60 mg SC|
53200|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53201|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53202|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53203|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53204|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53205|NCT01871558|E2|Reported Event|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53206|NCT01871558|E1|Reported Event|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
53207|NCT01871532|B3|Baseline|Total|Total of all reporting groups
53208|NCT01871532|B2|Baseline|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53209|NCT01871532|B1|Baseline|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53210|NCT01871532|P2|Participant Flow|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53211|NCT01871532|P1|Participant Flow|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53212|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53213|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53214|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53215|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53216|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53217|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53218|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53219|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53220|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53221|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53222|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53223|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53224|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53225|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53226|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53227|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53228|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53229|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53230|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53231|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53232|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53233|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53234|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53235|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53236|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53237|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53238|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53239|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53240|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53241|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53242|NCT01871532|E2|Reported Event|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53243|NCT01871532|E1|Reported Event|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
53244|NCT01871519|B1|Baseline|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53245|NCT01871519|P1|Participant Flow|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53246|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53247|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53248|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53500|NCT01869647|B4|Baseline|Total|Total of all reporting groups
53249|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53250|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53251|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53252|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53253|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53254|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53255|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53256|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53257|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53258|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53259|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53260|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53261|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53262|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53263|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53301|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53264|NCT01871519|E1|Reported Event|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
53265|NCT01871402|B3|Baseline|Total|Total of all reporting groups
53266|NCT01871402|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53267|NCT01871402|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53268|NCT01871402|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53269|NCT01871402|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53270|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53271|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53272|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53273|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53274|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53275|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53276|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53277|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53278|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53279|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53280|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53281|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53282|NCT01871402|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
53283|NCT01871402|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
53284|NCT01871285|B3|Baseline|Total|Total of all reporting groups
53285|NCT01871285|B2|Baseline|MSE Dose Group 2|Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
53286|NCT01871285|B1|Baseline|MSE Dose Group 1|Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
53287|NCT01871285|P4|Participant Flow|MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)|MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
53288|NCT01871285|P3|Participant Flow|MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid|MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
53289|NCT01871285|P2|Participant Flow|MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)|MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
53290|NCT01871285|P1|Participant Flow|MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid|MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
53291|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53292|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
53293|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53294|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
53295|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53296|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
53297|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53298|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
53299|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53300|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
53332|NCT01871090|P2|Participant Flow|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53302|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
53303|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53304|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
53305|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53306|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
53307|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53308|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
53309|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
53310|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
53311|NCT01871285|E4|Reported Event|MSE Dose Group 2 - ATC Opioid|Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
53312|NCT01871285|E3|Reported Event|MSE Dose Group 2 - Buprenorphine|Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
53313|NCT01871285|E2|Reported Event|MSE Dose Group 1 - ATC Opioid|Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
53314|NCT01871285|E1|Reported Event|MSE Dose Group 1 - Buprenorphine|Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
53315|NCT01871142|B1|Baseline|Entire Study Population|All enrolled participant baseline data
53316|NCT01871142|P1|Participant Flow|Randomized Crossover Assignment|Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.
53317|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
53318|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
53319|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
53320|NCT01871142|O1|Outcome|Placebo + Normoxia|"Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
53321|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
53322|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
53323|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
53324|NCT01871142|O1|Outcome|Palcebo + Normoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
53325|NCT01871142|E4|Reported Event|Hypoxia 3000 mg Aes-103 + Hypoxia|"Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen"
53326|NCT01871142|E3|Reported Event|1000 mg Aes-103 + Hypoxia|"Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
53327|NCT01871142|E2|Reported Event|Placebo + Hypoxia|"Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
53328|NCT01871142|E1|Reported Event|Placebo + Normoxia|"Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
53329|NCT01871090|B3|Baseline|Total|Total of all reporting groups
53330|NCT01871090|B2|Baseline|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53331|NCT01871090|B1|Baseline|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
102096|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
53333|NCT01871090|P1|Participant Flow|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
53334|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53335|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
53336|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53337|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
53338|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53339|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
53340|NCT01871090|E2|Reported Event|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
53341|NCT01871090|E1|Reported Event|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
53342|NCT01870999|B4|Baseline|Total|Total of all reporting groups
53343|NCT01870999|B3|Baseline|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53344|NCT01870999|B2|Baseline|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53345|NCT01870999|B1|Baseline|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53346|NCT01870999|P3|Participant Flow|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53347|NCT01870999|P2|Participant Flow|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53348|NCT01870999|P1|Participant Flow|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53349|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53350|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53351|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53352|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53353|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53354|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53355|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53356|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53357|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53429|NCT01870856|E2|Reported Event|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53358|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53359|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53360|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53361|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53362|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53363|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53364|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53365|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53366|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53367|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53368|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53369|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53370|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53371|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53372|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53373|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53374|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53375|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53376|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53377|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53430|NCT01870856|E1|Reported Event|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
56707|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
53378|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53379|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53380|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53381|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53382|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53383|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53384|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53385|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53386|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53387|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53388|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53389|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53390|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53391|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53392|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53393|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53394|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53395|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53396|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53397|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53491|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53492|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53398|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53399|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53400|NCT01870999|E3|Reported Event|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53401|NCT01870999|E2|Reported Event|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53402|NCT01870999|E1|Reported Event|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
53403|NCT01870973|B3|Baseline|Total|Total of all reporting groups
53404|NCT01870973|B2|Baseline|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
53405|NCT01870973|B1|Baseline|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
53406|NCT01870973|P2|Participant Flow|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
53407|NCT01870973|P1|Participant Flow|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
53408|NCT01870973|O2|Outcome|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
53409|NCT01870973|O1|Outcome|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
53410|NCT01870973|E2|Reported Event|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
53411|NCT01870973|E1|Reported Event|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
53412|NCT01870921|B1|Baseline|Ticargrelor|90 mg/tablet, 1 tablet bid
53413|NCT01870921|P1|Participant Flow|Ticargrelor|90 mg/tablet, 1 tablet bid
53414|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
53415|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
53416|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
53417|NCT01870921|E1|Reported Event|Ticargrelor|90 mg/tablet, 1 tablet bid
53418|NCT01870856|B3|Baseline|Total|Total of all reporting groups
53419|NCT01870856|B2|Baseline|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53420|NCT01870856|B1|Baseline|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
53421|NCT01870856|P2|Participant Flow|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53422|NCT01870856|P1|Participant Flow|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
53423|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53424|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53425|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53426|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53427|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
53428|NCT01870856|O1|Outcome|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
53431|NCT01870843|B1|Baseline|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53432|NCT01870843|P1|Participant Flow|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53433|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53434|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53435|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53436|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53437|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53438|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53439|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53440|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53441|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53442|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53443|NCT01870843|E1|Reported Event|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
53444|NCT01870739|B3|Baseline|Total|Total of all reporting groups
53445|NCT01870739|B2|Baseline|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53446|NCT01870739|B1|Baseline|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53447|NCT01870739|P2|Participant Flow|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53448|NCT01870739|P1|Participant Flow|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53449|NCT01870739|O6|Outcome|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
53450|NCT01870739|O5|Outcome|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
53451|NCT01870739|O4|Outcome|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
53452|NCT01870739|O3|Outcome|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
53453|NCT01870739|O2|Outcome|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
53454|NCT01870739|O1|Outcome|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
53455|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53456|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53457|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53458|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53459|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53460|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53461|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53462|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53463|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53464|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53465|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53466|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53467|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53468|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53469|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53470|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53471|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53472|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
53473|NCT01870739|E6|Reported Event|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
53474|NCT01870739|E5|Reported Event|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
53475|NCT01870739|E4|Reported Event|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
53476|NCT01870739|E3|Reported Event|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
53477|NCT01870739|E2|Reported Event|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
53478|NCT01870739|E1|Reported Event|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
53479|NCT01870596|B3|Baseline|Total|Total of all reporting groups
53480|NCT01870596|B2|Baseline|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53481|NCT01870596|B1|Baseline|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53482|NCT01870596|P2|Participant Flow|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53483|NCT01870596|P1|Participant Flow|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53484|NCT01870596|O2|Outcome|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53485|NCT01870596|O1|Outcome|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53486|NCT01870596|E2|Reported Event|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53487|NCT01870596|E1|Reported Event|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
53488|NCT01869686|B1|Baseline|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53489|NCT01869686|P1|Participant Flow|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53490|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
53501|NCT01869647|B3|Baseline|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
53502|NCT01869647|B2|Baseline|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
53503|NCT01869647|B1|Baseline|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
53504|NCT01869647|P3|Participant Flow|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
53505|NCT01869647|P2|Participant Flow|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
53506|NCT01869647|P1|Participant Flow|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
53507|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
53508|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
53509|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
53510|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
53511|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
53512|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
53513|NCT01869647|E3|Reported Event|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
53514|NCT01869647|E2|Reported Event|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
53545|NCT01869075|O1|Outcome|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53515|NCT01869647|E1|Reported Event|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
53516|NCT01869478|B3|Baseline|Total|Total of all reporting groups
53517|NCT01869478|B2|Baseline|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
53518|NCT01869478|B1|Baseline|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
53519|NCT01869478|P2|Participant Flow|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
53520|NCT01869478|P1|Participant Flow|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
53521|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
53522|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
53523|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
53524|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
53525|NCT01869478|E2|Reported Event|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
53526|NCT01869478|E1|Reported Event|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
53527|NCT01869075|B7|Baseline|Total|Total of all reporting groups
53528|NCT01869075|B6|Baseline|HFS - Usual Care|Usual Care as provided at the hospital.
53529|NCT01869075|B5|Baseline|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53530|NCT01869075|B4|Baseline|MGS - Usual Care|Usual Care as provided at the hospital.
53531|NCT01869075|B3|Baseline|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53532|NCT01869075|B2|Baseline|AMI - Usual Care|Usual care as provided at the hospital.
53533|NCT01869075|B1|Baseline|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53534|NCT01869075|P6|Participant Flow|HFS - Usual Care|Usual care provided at the hospital
53535|NCT01869075|P5|Participant Flow|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53536|NCT01869075|P4|Participant Flow|MGS - Usual Care|Usual care provided at the hospital
53537|NCT01869075|P3|Participant Flow|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53538|NCT01869075|P2|Participant Flow|AMI - Usual Care|Usual care provided at the hospital
53539|NCT01869075|P1|Participant Flow|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53540|NCT01869075|O6|Outcome|HFS - Usual Care|Usual Care as provided at the hospital
53541|NCT01869075|O5|Outcome|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53542|NCT01869075|O4|Outcome|MGS - Usual Care|Usual Care as provided at the hospital
53543|NCT01869075|O3|Outcome|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53544|NCT01869075|O2|Outcome|AMI - Usual Care|Usual care as provided at the hospital
53546|NCT01869075|E6|Reported Event|HFS - Usual Care|Usual Care as provided at the hospital
102097|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
53547|NCT01869075|E5|Reported Event|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53548|NCT01869075|E4|Reported Event|MGS - Usual Care|Usual Care as provided at the hospital
53549|NCT01869075|E3|Reported Event|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53550|NCT01869075|E2|Reported Event|AMI - Usual Care|Usual care as provided at the hospital
53551|NCT01869075|E1|Reported Event|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
53552|NCT01868893|B1|Baseline|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
53553|NCT01868893|P1|Participant Flow|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
53554|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
53555|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
53556|NCT01868893|O2|Outcome|Chlorambucil|Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
53557|NCT01868893|O1|Outcome|Obinutuzumab|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
53558|NCT01868893|E1|Reported Event|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
53559|NCT01868776|B3|Baseline|Total|Total of all reporting groups
53560|NCT01868776|B2|Baseline|Nonbuffered|nonbuffered lidocaine
53561|NCT01868776|B1|Baseline|Buffered|buffered lidocaine
53562|NCT01868776|P2|Participant Flow|Nonbuffered|nonbuffered lidocaine
53563|NCT01868776|P1|Participant Flow|Buffered|buffered lidocaine
53564|NCT01868776|O2|Outcome|Nonbuffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine~nonbuffered lidocaine"
53565|NCT01868776|O1|Outcome|Buffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.~buffered lidocaine"
53566|NCT01868776|E2|Reported Event|Nonbuffered|nonbuffered lidocaine
53567|NCT01868776|E1|Reported Event|Buffered|buffered lidocaine
53568|NCT01868542|B3|Baseline|Total|Total of all reporting groups
53569|NCT01868542|B2|Baseline|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53570|NCT01868542|B1|Baseline|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53571|NCT01868542|P2|Participant Flow|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53572|NCT01868542|P1|Participant Flow|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53573|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53574|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53575|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53576|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53577|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53578|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53579|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53620|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53714|NCT01867021|E1|Reported Event|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53580|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53581|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53582|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53583|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53584|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53585|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
53586|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
53587|NCT01868542|E2|Reported Event|Insulin Detemir (2-4-6-8 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir."
53621|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
54110|NCT01859793|E2|Reported Event|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
53588|NCT01868542|E1|Reported Event|Insulin Detemir (3-0-3 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir."
53589|NCT01868503|B1|Baseline|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
53590|NCT01868503|P1|Participant Flow|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
53591|NCT01868503|O1|Outcome|Lapatinib Plus Radiation Therapy|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
53592|NCT01868503|E1|Reported Event|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
53593|NCT01868243|B3|Baseline|Total|Total of all reporting groups
53594|NCT01868243|B2|Baseline|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose"
53595|NCT01868243|B1|Baseline|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)"
53596|NCT01868243|P2|Participant Flow|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
53597|NCT01868243|P1|Participant Flow|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
53598|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
53599|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
53600|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
53601|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
53602|NCT01868243|E2|Reported Event|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
53603|NCT01868243|E1|Reported Event|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
53604|NCT01868074|B3|Baseline|Total|Total of all reporting groups
53605|NCT01868074|B2|Baseline|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
53606|NCT01868074|B1|Baseline|Customized Insole|These participants were casted for customized insoles.
53607|NCT01868074|P2|Participant Flow|Usual Care Group|Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
53608|NCT01868074|P1|Participant Flow|Customized Insole Group|Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16” semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
53609|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
53610|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
53611|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
53612|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
53613|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
53614|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
53615|NCT01868074|E2|Reported Event|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
53616|NCT01868074|E1|Reported Event|Customized Insole|These participants were casted for customized insoles.
53617|NCT01868035|B1|Baseline|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53618|NCT01868035|P1|Participant Flow|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53619|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53712|NCT01867021|E3|Reported Event|Total|Total number of Subjects
53622|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53623|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53624|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53625|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53626|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53627|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53628|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53629|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53630|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53631|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53632|NCT01868035|E1|Reported Event|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
53633|NCT01868009|B1|Baseline|DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53634|NCT01868009|P2|Participant Flow|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53635|NCT01868009|P1|Participant Flow|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.
53636|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53637|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53638|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53639|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53640|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53641|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
53642|NCT01868009|E2|Reported Event|DISKUS BID in Period 1 or 2|Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
53643|NCT01868009|E1|Reported Event|ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.
53644|NCT01867710|B5|Baseline|Total|Total of all reporting groups
53645|NCT01867710|B4|Baseline|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
53646|NCT01867710|B3|Baseline|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
53647|NCT01867710|B2|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
53648|NCT01867710|B1|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
53649|NCT01867710|P4|Participant Flow|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
53650|NCT01867710|P3|Participant Flow|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
53651|NCT01867710|P2|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
53652|NCT01867710|P1|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
53653|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
53654|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
53655|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
53656|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
53657|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
53658|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
53659|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
53660|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
53661|NCT01867710|E4|Reported Event|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
53662|NCT01867710|E3|Reported Event|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
53663|NCT01867710|E2|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
53664|NCT01867710|E1|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
53665|NCT01867658|B1|Baseline|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53666|NCT01867658|P1|Participant Flow|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53667|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53668|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53669|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53670|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53671|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53672|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53673|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53713|NCT01867021|E2|Reported Event|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53674|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53675|NCT01867658|E1|Reported Event|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
53676|NCT01867164|B3|Baseline|Total|Total of all reporting groups
53677|NCT01867164|B2|Baseline|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53678|NCT01867164|B1|Baseline|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53679|NCT01867164|P2|Participant Flow|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
53680|NCT01867164|P1|Participant Flow|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53681|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53682|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53683|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53684|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53685|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53686|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53687|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53688|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53689|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53690|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53691|NCT01867164|E2|Reported Event|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
53692|NCT01867164|E1|Reported Event|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
53693|NCT01867021|B3|Baseline|Total|Total of all reporting groups
53694|NCT01867021|B2|Baseline|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53695|NCT01867021|B1|Baseline|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53696|NCT01867021|P2|Participant Flow|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53697|NCT01867021|P1|Participant Flow|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53698|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53699|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53700|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
53701|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
53702|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
53703|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
53704|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
53705|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
53706|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
53707|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
53708|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53709|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53710|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
53711|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
53715|NCT01865812|B1|Baseline|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53716|NCT01865812|P1|Participant Flow|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53717|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53718|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53719|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53720|NCT01865812|E1|Reported Event|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
53721|NCT01866709|B3|Baseline|Total|Total of all reporting groups
53722|NCT01866709|B2|Baseline|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention (give reasons) (n= 0)~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons"
53723|NCT01866709|B1|Baseline|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons"
53724|NCT01866709|P2|Participant Flow|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
53725|NCT01866709|P1|Participant Flow|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
53726|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
53727|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
53728|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
54111|NCT01859793|E1|Reported Event|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
53729|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
53730|NCT01866709|E2|Reported Event|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
53731|NCT01866709|E1|Reported Event|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
53732|NCT01866319|B4|Baseline|Total|Total of all reporting groups
53733|NCT01866319|B3|Baseline|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53734|NCT01866319|B2|Baseline|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
53735|NCT01866319|B1|Baseline|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
53736|NCT01866319|P3|Participant Flow|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53737|NCT01866319|P2|Participant Flow|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to 2 years
53738|NCT01866319|P1|Participant Flow|Ipilimumab|Participants receive ipilimumab, 3 mg/kg intravenously (IV), once eveery 3 weeks (Q3W) for a total of 4 doses
53739|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53740|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
53741|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
53742|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53743|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
53744|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
53745|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53746|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
53747|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
53748|NCT01866319|E3|Reported Event|Pembrolizumab 10 mg/kg Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
53749|NCT01866319|E2|Reported Event|Pembrolizumab 10 mg/kg Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
53750|NCT01866319|E1|Reported Event|Ipilimumab 3 mg/kg Q3W|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
53751|NCT01866163|B3|Baseline|Total|Total of all reporting groups
53752|NCT01866163|B2|Baseline|Vehicle|Aerosol foam vehicle
53753|NCT01866163|B1|Baseline|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53754|NCT01866163|P2|Participant Flow|Vehicle|Aerosol foam vehicle
53755|NCT01866163|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53756|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
53757|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53758|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
53759|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53760|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
53761|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53762|NCT01866163|E2|Reported Event|Vehicle|Aerosol foam vehicle
53763|NCT01866163|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
53764|NCT01866150|B1|Baseline|Overall Population|Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.
53765|NCT01866150|P1|Participant Flow|Overall Population|Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).
53766|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53767|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53768|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53769|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53770|NCT01866150|O1|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
54112|NCT01859715|B4|Baseline|Total|Total of all reporting groups
102098|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
53771|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53772|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53773|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53774|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53775|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53776|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53777|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53778|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53779|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53780|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53781|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53782|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
53783|NCT01866150|E2|Reported Event|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
53784|NCT01866150|E1|Reported Event|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.
53785|NCT01864434|B3|Baseline|Total|Total of all reporting groups
53786|NCT01864434|B2|Baseline|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53787|NCT01864434|B1|Baseline|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53788|NCT01864434|P2|Participant Flow|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53789|NCT01864434|P1|Participant Flow|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53790|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53791|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53792|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53793|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53794|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53795|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53796|NCT01864434|E2|Reported Event|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
53797|NCT01864434|E1|Reported Event|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
53798|NCT01864005|B3|Baseline|Total|Total of all reporting groups
53799|NCT01864005|B2|Baseline|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53800|NCT01864005|B1|Baseline|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53801|NCT01864005|P2|Participant Flow|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53802|NCT01864005|P1|Participant Flow|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53803|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53804|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53805|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53806|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53807|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53808|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53809|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53810|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53811|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53812|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53813|NCT01864005|E2|Reported Event|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
53814|NCT01864005|E1|Reported Event|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
53815|NCT01863953|B4|Baseline|Total|Total of all reporting groups
53816|NCT01863953|B3|Baseline|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
53817|NCT01863953|B2|Baseline|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53818|NCT01863953|B1|Baseline|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53819|NCT01863953|P3|Participant Flow|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
53820|NCT01863953|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53821|NCT01863953|P1|Participant Flow|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53822|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
53823|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53824|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53825|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
53826|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53827|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53828|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
54188|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes
53829|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53830|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53831|NCT01863953|E3|Reported Event|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
53832|NCT01863953|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
53833|NCT01863953|E1|Reported Event|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
53834|NCT01863771|B1|Baseline|All Participants|Participants who received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC) in the induction phase.
53835|NCT01863771|P4|Participant Flow|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 weeks through Week 52.
53836|NCT01863771|P3|Participant Flow|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
53837|NCT01863771|P2|Participant Flow|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
53838|NCT01863771|P1|Participant Flow|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
53839|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
53840|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
53841|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
53842|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
53843|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
53844|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
53845|NCT01863771|E4|Reported Event|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 week through Week 52.
53846|NCT01863771|E3|Reported Event|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
53847|NCT01863771|E2|Reported Event|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
53848|NCT01863771|E1|Reported Event|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
53849|NCT01863680|B1|Baseline|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro fertilization and embryo transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53850|NCT01863680|P1|Participant Flow|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53851|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53881|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53882|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53852|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53853|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53854|NCT01863680|E1|Reported Event|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
53855|NCT01863667|B3|Baseline|Total|Total of all reporting groups
53856|NCT01863667|B2|Baseline|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53857|NCT01863667|B1|Baseline|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53858|NCT01863667|P2|Participant Flow|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53859|NCT01863667|P1|Participant Flow|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53860|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53861|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53862|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53863|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53864|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53865|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53866|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53867|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53868|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53869|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53870|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53871|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53872|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53873|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53874|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53875|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53876|NCT01863667|E2|Reported Event|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
53877|NCT01863667|E1|Reported Event|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
53878|NCT01863433|B1|Baseline|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53879|NCT01863433|P1|Participant Flow|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53880|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
54189|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes
54190|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
53883|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53884|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53885|NCT01863433|E1|Reported Event|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
53886|NCT01863368|B3|Baseline|Total|Total of all reporting groups
53887|NCT01863368|B2|Baseline|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53888|NCT01863368|B1|Baseline|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53889|NCT01863368|P2|Participant Flow|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53890|NCT01863368|P1|Participant Flow|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53891|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53892|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53893|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53894|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53895|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53896|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53897|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53898|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
53899|NCT01863368|E3|Reported Event|Optive|All subjects who were exposed to Optive or run-in therapy
53900|NCT01863368|E2|Reported Event|Systane Ultra|All subjects who were exposed to Systane Ultra or run-in therapy
53901|NCT01863368|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
53902|NCT01863134|B3|Baseline|Total|Total of all reporting groups
53903|NCT01863134|B2|Baseline|Eptifibatide|In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.
53904|NCT01863134|B1|Baseline|Placebo/Control Group|In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.
53905|NCT01863134|P2|Participant Flow|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53906|NCT01863134|P1|Participant Flow|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53907|NCT01863134|O2|Outcome|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53908|NCT01863134|O1|Outcome|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53909|NCT01863134|E2|Reported Event|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53910|NCT01863134|E1|Reported Event|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
53911|NCT01862484|B3|Baseline|Total|Total of all reporting groups
53912|NCT01862484|B2|Baseline|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
53913|NCT01862484|B1|Baseline|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
53914|NCT01862484|P2|Participant Flow|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
53915|NCT01862484|P1|Participant Flow|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
53916|NCT01862484|O2|Outcome|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
53917|NCT01862484|O1|Outcome|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
53918|NCT01862484|E2|Reported Event|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
53919|NCT01862484|E1|Reported Event|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
53920|NCT01862419|B3|Baseline|Total|Total of all reporting groups
53921|NCT01862419|B2|Baseline|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53922|NCT01862419|B1|Baseline|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53923|NCT01862419|P2|Participant Flow|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53924|NCT01862419|P1|Participant Flow|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53925|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53926|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53927|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53928|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53929|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53930|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53931|NCT01862419|E2|Reported Event|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
53932|NCT01862419|E1|Reported Event|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
53933|NCT01862133|B1|Baseline|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
53934|NCT01862133|P2|Participant Flow|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study"
53935|NCT01862133|P1|Participant Flow|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
53936|NCT01862133|O2|Outcome|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study~24"
53937|NCT01862133|O1|Outcome|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
53991|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
54191|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
53938|NCT01862133|E2|Reported Event|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences."
53939|NCT01862133|E1|Reported Event|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
53940|NCT01861925|B4|Baseline|Total|Total of all reporting groups
53941|NCT01861925|B3|Baseline|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53942|NCT01861925|B2|Baseline|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53943|NCT01861925|B1|Baseline|Normal Eye|Astigmatism smaller than 1.5 diopters
53944|NCT01861925|P3|Participant Flow|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53945|NCT01861925|P2|Participant Flow|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53946|NCT01861925|P1|Participant Flow|Normal Eye|Astigmatism smaller than 1.5 diopters
53947|NCT01861925|O1|Outcome|Regular Eye|"Astigmatism smaller than 1.5 diopters and regular astigmatism >= 1.5 diopters (group normal eye and large regular astigmatism)"
53948|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53949|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53950|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
53951|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53952|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53953|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
53954|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53955|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53956|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
53957|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53958|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53959|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
53960|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53961|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53962|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
53963|NCT01861925|E3|Reported Event|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
53964|NCT01861925|E2|Reported Event|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
53965|NCT01861925|E1|Reported Event|Normal Eye|Astigmatism smaller than 1.5 diopters
53966|NCT01861704|B3|Baseline|Total|Total of all reporting groups
53967|NCT01861704|B2|Baseline|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
53968|NCT01861704|B1|Baseline|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
53969|NCT01861704|P2|Participant Flow|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
53970|NCT01861704|P1|Participant Flow|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
53971|NCT01861704|O2|Outcome|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
53972|NCT01861704|O1|Outcome|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
53973|NCT01861704|E2|Reported Event|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
53974|NCT01861704|E1|Reported Event|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
53975|NCT01861522|B3|Baseline|Total|Total of all reporting groups
53976|NCT01861522|B2|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
53977|NCT01861522|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
53978|NCT01861522|P2|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
53979|NCT01861522|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
53980|NCT01861522|O2|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
53981|NCT01861522|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
53982|NCT01861522|E2|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
53983|NCT01861522|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
53984|NCT01861457|B3|Baseline|Total|Total of all reporting groups
53985|NCT01861457|B2|Baseline|Saline Placebo|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Placebo"
53986|NCT01861457|B1|Baseline|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Nozin Nasal Sanitizer"
53987|NCT01861457|P2|Participant Flow|Phosphate-buffered Saline (PBS) Placebo|Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
53988|NCT01861457|P1|Participant Flow|Nozin® Nasal Sanitizer®|Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
53989|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
53990|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
53992|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
53993|NCT01861457|E2|Reported Event|Sham|"Apply 4 rotations of swab to each nostril every four hours ...~Sham"
53994|NCT01861457|E1|Reported Event|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril every four hours~Nozin Nasal Sanitizer"
53995|NCT01861301|B1|Baseline|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
53996|NCT01861301|P1|Participant Flow|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
53997|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
53998|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
53999|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
54000|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
54001|NCT01861301|E1|Reported Event|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
54002|NCT01860989|B1|Baseline|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
54003|NCT01860989|P1|Participant Flow|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
54004|NCT01860989|O1|Outcome|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
54005|NCT01860989|E1|Reported Event|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
54006|NCT01860703|B1|Baseline|All Subjects|Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.
54007|NCT01860703|P4|Participant Flow|DCBA|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone"
54008|NCT01860703|P3|Participant Flow|CADB|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone"
54009|NCT01860703|P2|Participant Flow|BDAC|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo"
54010|NCT01860703|P1|Participant Flow|ABCD|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin"
54011|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54012|NCT01860703|O1|Outcome|Positive Control|A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.
54013|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
54014|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54015|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54016|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54017|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
54018|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54101|NCT01859793|B1|Baseline|Matching Placebo 1st|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
54019|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54020|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54021|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54022|NCT01860703|O1|Outcome|50 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54023|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54024|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54025|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54026|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54027|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54028|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54029|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54030|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54031|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
54032|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54033|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54034|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54035|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54036|NCT01860703|O1|Outcome|33 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
54037|NCT01860703|E4|Reported Event|Treatment Arm D - Positive Control|"Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.~Deferiprone~moxifloxacin"
54038|NCT01860703|E3|Reported Event|Treatment Arm C - Placebo Control|"Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
54039|NCT01860703|E2|Reported Event|Treatment Arm B - Supratherapeutic Dose|"Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.~Deferiprone~moxifloxacin matching placebo tablet"
54192|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
54040|NCT01860703|E1|Reported Event|Treatment Arm A - Maximum Therapeutic Dose|"Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~Deferiprone~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
54041|NCT01860534|B3|Baseline|Total|Total of all reporting groups
54042|NCT01860534|B2|Baseline|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54043|NCT01860534|B1|Baseline|Eye Patches Initially Then no Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54044|NCT01860534|P2|Participant Flow|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
54045|NCT01860534|P1|Participant Flow|Eye Patch Initially Then no Eye Patch|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
54046|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54047|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54048|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54049|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54050|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54102|NCT01859793|P2|Participant Flow|Sitagliptin First Then Placebo|sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
54103|NCT01859793|P1|Participant Flow|Placebo 1st Then Sitagliptin|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period"
54193|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
54051|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54052|NCT01860534|O2|Outcome|no Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54053|NCT01860534|O1|Outcome|Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54054|NCT01860534|E2|Reported Event|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54055|NCT01860534|E1|Reported Event|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
54056|NCT01860521|B3|Baseline|Total|Total of all reporting groups
54057|NCT01860521|B2|Baseline|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54058|NCT01860521|B1|Baseline|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54059|NCT01860521|P2|Participant Flow|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54060|NCT01860521|P1|Participant Flow|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54104|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
54105|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
54106|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
54107|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
54194|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
54061|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54062|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54063|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54064|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54065|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54066|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54067|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54068|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54069|NCT01860521|E2|Reported Event|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54108|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
54109|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
54195|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
54070|NCT01860521|E1|Reported Event|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
54071|NCT01860079|B3|Baseline|Total|Total of all reporting groups
54072|NCT01860079|B2|Baseline|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
54073|NCT01860079|B1|Baseline|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
54074|NCT01860079|P2|Participant Flow|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure.
54075|NCT01860079|P1|Participant Flow|Early Discharge Group|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
54076|NCT01860079|O2|Outcome|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
54077|NCT01860079|O1|Outcome|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
54078|NCT01860079|E2|Reported Event|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
54079|NCT01860079|E1|Reported Event|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group."
54080|NCT01859949|B3|Baseline|Total|Total of all reporting groups
54081|NCT01859949|B2|Baseline|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54082|NCT01859949|B1|Baseline|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54083|NCT01859949|P2|Participant Flow|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54084|NCT01859949|P1|Participant Flow|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54085|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54086|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54087|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54088|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54089|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54090|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54091|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54092|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54093|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54094|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54095|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
54096|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54097|NCT01859949|E2|Reported Event|Dose-Remainig Group|Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
54098|NCT01859949|E1|Reported Event|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
54099|NCT01859793|B3|Baseline|Total|Total of all reporting groups
54100|NCT01859793|B2|Baseline|Sitagliptin 1st|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
54113|NCT01859715|B3|Baseline|Nausea-observational Group|Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
54114|NCT01859715|B2|Baseline|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
54115|NCT01859715|B1|Baseline|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
54116|NCT01859715|P3|Participant Flow|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
54117|NCT01859715|P2|Participant Flow|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
54118|NCT01859715|P1|Participant Flow|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
54119|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
54120|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
54121|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
54122|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
54123|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
54124|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
54125|NCT01859715|E3|Reported Event|Nausea-observational Group|"Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only."
54126|NCT01859715|E2|Reported Event|Hydrocodone/Acetaminophen Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
54127|NCT01859715|E1|Reported Event|Oxycodone Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
54128|NCT01859702|B1|Baseline|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
54129|NCT01859702|P1|Participant Flow|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
54130|NCT01859702|O1|Outcome|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
54131|NCT01859702|E1|Reported Event|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
54132|NCT01859637|B1|Baseline|Zarzio®/Filgrastim HEXAL®|Open label single arm. All patients received Zarzio®/Filgrastim HEXAL® subcutaneously dosed as per recommendations in SmPC.
54133|NCT01859637|P1|Participant Flow|Zarzio®/Filgrastim HEXAL® (EP2006)|Open label single arm. All patients received Zarzio® subcutaneously dosed as per recommendations in Summary of Product Characteristics (SmPC).
54134|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
54135|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
54136|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
54137|NCT01859637|E1|Reported Event|Open-label Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
54138|NCT01859611|B1|Baseline|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
54139|NCT01859611|P1|Participant Flow|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
54196|NCT01859247|E8|Reported Event|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
54238|NCT01858766|B3|Baseline|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
54140|NCT01859611|O1|Outcome|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
54141|NCT01859611|E1|Reported Event|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
54142|NCT01859598|B1|Baseline|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
54143|NCT01859598|P1|Participant Flow|6-month Follow-up for Basal Insulin Treatment Study (ORBIT)|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
54144|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
54145|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
54146|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
54147|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
54148|NCT01859598|O1|Outcome|Basal Insulin Treatment Study (ORBIT)|
54149|NCT01859598|E1|Reported Event|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
54150|NCT01859507|B1|Baseline|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
54151|NCT01859507|P1|Participant Flow|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
54152|NCT01859507|O1|Outcome|BOTOX Group|"Injection of BOTOX 100 units vial as a single dose intramuscular in the perineal muscles. Proper informed consent forms will be signed. In most of the cases we use local anesthetic before injection. However in V4 and 5 we resort to general anesthesia. We followed up the patient by phone calls daily for possible adverse effects following the procedure for 4 days, which is the interval allowed for the BOTOX to be fully effective. The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We start each session with the appropriate size of the dilator according to the capacity of the introitus and increase the size gradually thereafter. We proceed till the patient uses the largest dilator with no or limited pain. The patient is then advised then to try to have intercourse and report back to us.~Botox: In the first session, proper histor"
54153|NCT01859507|O1|Outcome|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
54154|NCT01859507|E1|Reported Event|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
54155|NCT01859494|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54156|NCT01859494|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54157|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54197|NCT01859247|E7|Reported Event|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
54239|NCT01858766|B2|Baseline|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
54158|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54159|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54160|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54161|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54162|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54163|NCT01859494|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
54164|NCT01859247|B9|Baseline|Total|Total of all reporting groups
54165|NCT01859247|B8|Baseline|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
54166|NCT01859247|B7|Baseline|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
54167|NCT01859247|B6|Baseline|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
54168|NCT01859247|B5|Baseline|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
54169|NCT01859247|B4|Baseline|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
54170|NCT01859247|B3|Baseline|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
54171|NCT01859247|B2|Baseline|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
54172|NCT01859247|B1|Baseline|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
54173|NCT01859247|P8|Participant Flow|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
54174|NCT01859247|P7|Participant Flow|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
54175|NCT01859247|P6|Participant Flow|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
54176|NCT01859247|P5|Participant Flow|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
54177|NCT01859247|P4|Participant Flow|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
54178|NCT01859247|P3|Participant Flow|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
54179|NCT01859247|P2|Participant Flow|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
54180|NCT01859247|P1|Participant Flow|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
54181|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
54182|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
54183|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
54184|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
54185|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
54186|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes
54187|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes
54198|NCT01859247|E6|Reported Event|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
54199|NCT01859247|E5|Reported Event|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
54200|NCT01859247|E4|Reported Event|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
54201|NCT01859247|E3|Reported Event|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
54202|NCT01859247|E2|Reported Event|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
54203|NCT01859247|E1|Reported Event|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
54204|NCT01859143|B3|Baseline|Total|Total of all reporting groups
54205|NCT01859143|B2|Baseline|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54206|NCT01859143|B1|Baseline|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
54207|NCT01859143|P2|Participant Flow|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54208|NCT01859143|P1|Participant Flow|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
54209|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54210|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
54211|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54212|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
54213|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54214|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
54215|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54216|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
54217|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54218|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
54219|NCT01859143|E2|Reported Event|PLACEBO|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
54220|NCT01859143|E1|Reported Event|TRIVALENT VACCINE|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
54221|NCT01858766|B20|Baseline|Total|Total of all reporting groups
54222|NCT01858766|B19|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54223|NCT01858766|B18|Baseline|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
54224|NCT01858766|B17|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54225|NCT01858766|B16|Baseline|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
54226|NCT01858766|B15|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54227|NCT01858766|B14|Baseline|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
54228|NCT01858766|B13|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54229|NCT01858766|B12|Baseline|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
54230|NCT01858766|B11|Baseline|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
54231|NCT01858766|B10|Baseline|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
54232|NCT01858766|B9|Baseline|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
54233|NCT01858766|B8|Baseline|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
54234|NCT01858766|B7|Baseline|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
54235|NCT01858766|B6|Baseline|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
54236|NCT01858766|B5|Baseline|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
54237|NCT01858766|B4|Baseline|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
56769|NCT01842464|B1|Baseline|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
54240|NCT01858766|B1|Baseline|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
54241|NCT01858766|P19|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54242|NCT01858766|P18|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
54243|NCT01858766|P17|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54244|NCT01858766|P16|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
54245|NCT01858766|P15|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54246|NCT01858766|P14|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
54247|NCT01858766|P13|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54248|NCT01858766|P12|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
54249|NCT01858766|P11|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
54250|NCT01858766|P10|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
54251|NCT01858766|P9|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
54252|NCT01858766|P8|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
54253|NCT01858766|P7|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
54254|NCT01858766|P6|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
54255|NCT01858766|P5|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
54256|NCT01858766|P4|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
54257|NCT01858766|P3|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
54258|NCT01858766|P2|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
54259|NCT01858766|P1|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT1)|Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
54260|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54261|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
54262|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54263|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
54264|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54265|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
54266|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54267|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
54268|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
54269|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
54270|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
54271|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
54272|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
54273|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
54274|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
54275|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
54276|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
54277|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
54278|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
54279|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
56770|NCT01842464|P1|Participant Flow|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
54280|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
54281|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54282|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
54283|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54284|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
54285|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54286|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
54287|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
54288|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
54289|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
54290|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
54291|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
54292|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
54293|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
54294|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
54295|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
54296|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
54297|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
54298|NCT01858766|O6|Outcome|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
54299|NCT01858766|O5|Outcome|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
54300|NCT01858766|O4|Outcome|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
54301|NCT01858766|O3|Outcome|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
54302|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
54303|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
54304|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54305|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
54306|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
54307|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
54308|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54309|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
54310|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
54311|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
54312|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
54313|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
54314|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
54315|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
54316|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
54317|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
54318|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
54319|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
54320|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
54321|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
54322|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
54323|NCT01858766|E6|Reported Event|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
54324|NCT01858766|E5|Reported Event|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
54325|NCT01858766|E4|Reported Event|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
54326|NCT01858766|E3|Reported Event|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
54327|NCT01858766|E2|Reported Event|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
54328|NCT01858766|E1|Reported Event|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
54329|NCT01858701|B1|Baseline|Overall|Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
54330|NCT01858701|P2|Participant Flow|Biofinity Toric / AO for Astig|Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
54331|NCT01858701|P1|Participant Flow|AO for Astig / Biofinity Toric|Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
54332|NCT01858701|O2|Outcome|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
54333|NCT01858701|O1|Outcome|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
54334|NCT01858701|E2|Reported Event|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
54335|NCT01858701|E1|Reported Event|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
54336|NCT01858636|B1|Baseline|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
54337|NCT01858636|P1|Participant Flow|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
54338|NCT01858636|O1|Outcome|Deployed Subjects|Subjects with Angio-Seal deployed
54339|NCT01858636|O1|Outcome|Deployed Subjects|Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
54340|NCT01858636|E1|Reported Event|Deployed Subjects|Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
54341|NCT01858376|B1|Baseline|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54342|NCT01858376|P1|Participant Flow|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54343|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54344|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54345|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54346|NCT01858376|E1|Reported Event|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
54347|NCT01857882|B3|Baseline|Total|Total of all reporting groups
54348|NCT01857882|B2|Baseline|Standard Care|Routine pre-consultation education
54349|NCT01857882|B1|Baseline|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
54350|NCT01857882|P2|Participant Flow|Standard Care|Routine pre-consultation education
54351|NCT01857882|P1|Participant Flow|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
54352|NCT01857882|O2|Outcome|Standard Care|Routine pre-consultation education
54353|NCT01857882|O1|Outcome|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
54354|NCT01857882|E2|Reported Event|Standard Care|Routine pre-consultation education
54355|NCT01857882|E1|Reported Event|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
54356|NCT01857713|B1|Baseline|Fitted With Reza Band UES Assist Device|Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
54357|NCT01857713|P1|Participant Flow|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
54358|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
54359|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
54360|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
54361|NCT01857713|O1|Outcome|Reza Band|Participants fitted with Reza Band UES Assist Device
54362|NCT01857713|E1|Reported Event|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
54363|NCT01857622|B4|Baseline|Total|Total of all reporting groups
54364|NCT01857622|B3|Baseline|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
54365|NCT01857622|B2|Baseline|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
54366|NCT01857622|B1|Baseline|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
54367|NCT01857622|P3|Participant Flow|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
54528|NCT01856686|P2|Participant Flow|Low Carbohydrate Diet|This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
54368|NCT01857622|P2|Participant Flow|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
54369|NCT01857622|P1|Participant Flow|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
54370|NCT01857622|O3|Outcome|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
54371|NCT01857622|O2|Outcome|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
54372|NCT01857622|O1|Outcome|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
54373|NCT01857622|E3|Reported Event|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
54374|NCT01857622|E2|Reported Event|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
54375|NCT01857622|E1|Reported Event|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
54376|NCT01857583|B5|Baseline|Total|Total of all reporting groups
54377|NCT01857583|B4|Baseline|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
54378|NCT01857583|B3|Baseline|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
54379|NCT01857583|B2|Baseline|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
54380|NCT01857583|B1|Baseline|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
54381|NCT01857583|P4|Participant Flow|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min) Fondaparinux"
54382|NCT01857583|P3|Participant Flow|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
54383|NCT01857583|P2|Participant Flow|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
54384|NCT01857583|P1|Participant Flow|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
54385|NCT01857583|O4|Outcome|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
54386|NCT01857583|O3|Outcome|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
54387|NCT01857583|O2|Outcome|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
54388|NCT01857583|O1|Outcome|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
54389|NCT01857583|E4|Reported Event|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)"
54390|NCT01857583|E3|Reported Event|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
54391|NCT01857583|E2|Reported Event|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
54392|NCT01857583|E1|Reported Event|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
54393|NCT01857531|B1|Baseline|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54529|NCT01856686|P1|Participant Flow|BP22042013|This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
54394|NCT01857531|P1|Participant Flow|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54395|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54396|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54397|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54398|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54399|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54400|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54401|NCT01857531|E1|Reported Event|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
54402|NCT01857362|B1|Baseline|Overall Study|All treatment arms
54403|NCT01857362|P2|Participant Flow|Nitisinone 2 x 10 mg, Then Nitisinone 1 x 20 mg|Participants first received two nitisinone capsules of 10 mg. After washout of 3 weeks participants then received one nitisinone capsule of 20 mg.
54404|NCT01857362|P1|Participant Flow|Nitisinone 1 x 20 mg, Then Nitisinone 2 x 10 mg|Participants first received one nitisinone capsule of 20 mg. After washout of 3 weeks participants then received two nitisinone capsules of 10 mg.
54405|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
54406|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
54407|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
54408|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
54409|NCT01857362|E2|Reported Event|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
54410|NCT01857362|E1|Reported Event|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
54411|NCT01857323|B1|Baseline|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54412|NCT01857323|P1|Participant Flow|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54413|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54414|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54415|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54416|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54417|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54418|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54599|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
56771|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
54419|NCT01857323|E1|Reported Event|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
54420|NCT01857297|B3|Baseline|Total|Total of all reporting groups
54421|NCT01857297|B2|Baseline|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54422|NCT01857297|B1|Baseline|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54423|NCT01857297|P2|Participant Flow|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54424|NCT01857297|P1|Participant Flow|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54425|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54426|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54427|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54428|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54429|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54430|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54431|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54432|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54433|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54434|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54435|NCT01857297|E2|Reported Event|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54436|NCT01857297|E1|Reported Event|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
54437|NCT01857258|B1|Baseline|Baseline Participant Characteristics|All participants completed both arms of the cross-over study
54438|NCT01857258|P2|Participant Flow|Control First, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
54439|NCT01857258|P1|Participant Flow|Green Tea First, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
54440|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54441|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54442|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54443|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54444|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54445|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54446|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54447|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54448|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
56772|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
54449|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54450|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54451|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54452|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54453|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54454|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54455|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54456|NCT01857258|E2|Reported Event|Control, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54457|NCT01857258|E1|Reported Event|Green Tea, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
54458|NCT01857206|B3|Baseline|TOTAL|Total of all reporting groups
54459|NCT01857206|B2|Baseline|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54460|NCT01857206|B1|Baseline|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54461|NCT01857206|P2|Participant Flow|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54462|NCT01857206|P1|Participant Flow|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54463|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54464|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54465|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54466|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54467|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54468|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54469|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54470|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54471|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54472|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54473|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54474|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54475|NCT01857206|E4|Reported Event|TIVf(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54476|NCT01857206|E3|Reported Event|TIVc(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54477|NCT01857206|E2|Reported Event|TIVf(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
54478|NCT01857206|E1|Reported Event|TIVc(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
54479|NCT01857063|B3|Baseline|Total|Total of all reporting groups
54480|NCT01857063|B2|Baseline|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
54481|NCT01857063|B1|Baseline|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
54482|NCT01857063|P2|Participant Flow|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
54483|NCT01857063|P1|Participant Flow|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
54484|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54485|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54486|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54487|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54488|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54489|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54490|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54491|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54492|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54493|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54494|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54495|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54496|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54497|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54498|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54499|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54500|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54501|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54502|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54503|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54504|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54505|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54506|NCT01857063|E2|Reported Event|Placebo|Participants receive placebo for 7 days, regardless of sequence.
54507|NCT01857063|E1|Reported Event|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
54508|NCT01856933|B1|Baseline|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
54509|NCT01856933|P1|Participant Flow|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
54510|NCT01856933|O1|Outcome|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
54511|NCT01856933|E1|Reported Event|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
54512|NCT01856764|B3|Baseline|Total|Total of all reporting groups
54513|NCT01856764|B2|Baseline|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54514|NCT01856764|B1|Baseline|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54515|NCT01856764|P2|Participant Flow|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54516|NCT01856764|P1|Participant Flow|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54517|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54518|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54519|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54520|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54521|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54522|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54523|NCT01856764|E2|Reported Event|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
54524|NCT01856764|E1|Reported Event|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
54525|NCT01856686|B3|Baseline|Total|Total of all reporting groups
54526|NCT01856686|B2|Baseline|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54527|NCT01856686|B1|Baseline|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
55143|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
54530|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54531|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54532|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54533|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54534|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54535|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54536|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54537|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54538|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54539|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54540|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54541|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54542|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54543|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54544|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54545|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54546|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54547|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54548|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54549|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54550|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54600|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54551|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54552|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54553|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54554|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54555|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54556|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54557|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54558|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54559|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54560|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54561|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54562|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54563|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54564|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54565|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54566|NCT01856686|E2|Reported Event|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
54567|NCT01856686|E1|Reported Event|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
54568|NCT01856673|B4|Baseline|Total|Total of all reporting groups
54569|NCT01856673|B3|Baseline|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
54601|NCT01856530|E2|Reported Event|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54602|NCT01856530|E1|Reported Event|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54603|NCT01856322|B4|Baseline|Total|Total of all reporting groups
54604|NCT01856322|B3|Baseline|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
102099|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
54570|NCT01856673|B2|Baseline|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
54571|NCT01856673|B1|Baseline|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
54572|NCT01856673|P3|Participant Flow|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
54573|NCT01856673|P2|Participant Flow|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
54574|NCT01856673|P1|Participant Flow|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
54575|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
54576|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
54577|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
54605|NCT01856322|B2|Baseline|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
54606|NCT01856322|B1|Baseline|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
54607|NCT01856322|P3|Participant Flow|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
54578|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
54579|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
54580|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
54581|NCT01856673|E3|Reported Event|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
54582|NCT01856673|E2|Reported Event|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
54583|NCT01856673|E1|Reported Event|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
54584|NCT01856530|B3|Baseline|Total|Total of all reporting groups
54585|NCT01856530|B2|Baseline|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54586|NCT01856530|B1|Baseline|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54587|NCT01856530|P2|Participant Flow|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54588|NCT01856530|P1|Participant Flow|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54589|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54590|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54591|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54592|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54593|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54594|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54595|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54596|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
54597|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
54598|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
102100|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
54612|NCT01856322|E3|Reported Event|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
54613|NCT01856322|E2|Reported Event|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
54614|NCT01856322|E1|Reported Event|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
54615|NCT01855997|B1|Baseline|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54616|NCT01855997|P1|Participant Flow|Adult Participants Treated With Peg-IFN|Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54617|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54618|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54619|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54620|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54621|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54622|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54623|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54624|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54625|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54626|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54627|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54628|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54629|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54709|NCT01855945|P5|Participant Flow|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54630|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54631|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54632|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54633|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54634|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54635|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54636|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54637|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54638|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54639|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54640|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54641|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54642|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54643|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54644|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54645|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54710|NCT01855945|P4|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
102101|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
54646|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54647|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54648|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54649|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54650|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54651|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54652|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54653|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54654|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54655|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54656|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54657|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54658|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54659|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54660|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54661|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54711|NCT01855945|P3|Participant Flow|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
55144|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
54662|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54663|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54664|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54665|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54666|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54667|NCT01855997|E1|Reported Event|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
54668|NCT01855958|B3|Baseline|Total|Total of all reporting groups
54669|NCT01855958|B2|Baseline|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54670|NCT01855958|B1|Baseline|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54671|NCT01855958|P2|Participant Flow|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54672|NCT01855958|P1|Participant Flow|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54673|NCT01855958|O2|Outcome|Placebo-sham|"The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.~Placebo-sham: Electro acupuncture with rubber electrodes, without current passing."
54674|NCT01855958|O1|Outcome|DIMST|"The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.~DIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes."
54712|NCT01855945|P2|Participant Flow|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54713|NCT01855945|P1|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54675|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54676|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54677|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54678|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54679|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54680|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54681|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54682|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54683|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54684|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54714|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54715|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54685|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54686|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54687|NCT01855958|E2|Reported Event|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
54688|NCT01855958|E1|Reported Event|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
54689|NCT01855945|B13|Baseline|Total|Total of all reporting groups
54690|NCT01855945|B12|Baseline|A/H3N2C : ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54691|NCT01855945|B11|Baseline|A/H3N2C + MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54692|NCT01855945|B10|Baseline|A/H3N2C + 1/2 MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54693|NCT01855945|B9|Baseline|A/H3N2C : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54694|NCT01855945|B8|Baseline|A/H3N2C + MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54695|NCT01855945|B7|Baseline|A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54696|NCT01855945|B6|Baseline|A/H3N2C : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54697|NCT01855945|B5|Baseline|A/H3N2C + MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54698|NCT01855945|B4|Baseline|A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54699|NCT01855945|B3|Baseline|A/H3N2C : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54700|NCT01855945|B2|Baseline|A/H3N2C + MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54701|NCT01855945|B1|Baseline|A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54702|NCT01855945|P12|Participant Flow|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54703|NCT01855945|P11|Participant Flow|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54704|NCT01855945|P10|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54705|NCT01855945|P9|Participant Flow|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54706|NCT01855945|P8|Participant Flow|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54707|NCT01855945|P7|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54708|NCT01855945|P6|Participant Flow|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
102102|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
54716|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54717|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54718|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54719|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54720|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54721|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54722|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54723|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54724|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54725|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54726|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54727|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54728|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54729|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54730|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54731|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54732|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54733|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54734|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54735|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54736|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54737|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54738|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54739|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54740|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54741|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54742|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54743|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54744|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54745|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54746|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
102103|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
54747|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54748|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54749|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54750|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54751|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54752|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54753|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54754|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54755|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54756|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54757|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54758|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54759|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54760|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54761|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54762|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54763|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54764|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54765|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54766|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54767|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54768|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54769|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54770|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54771|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54772|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54773|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54774|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54775|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54776|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54777|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
102104|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
54778|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54779|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54780|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54781|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54782|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54783|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54784|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54785|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54786|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54787|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54788|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54789|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54790|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54791|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54792|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54793|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54794|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54795|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54796|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54797|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54798|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54799|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54800|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54801|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54802|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54803|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54804|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54805|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54806|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54807|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54808|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54809|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54810|NCT01855945|O12|Outcome|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54811|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54812|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54813|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54814|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54815|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54816|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54817|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54818|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54819|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54820|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54821|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54822|NCT01855945|O3|Outcome|A/H3N2C - Age Group: ≥65 YEARS|Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.
54823|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
54824|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54825|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54826|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54827|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54828|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54829|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54830|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
54831|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54832|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
54833|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
54834|NCT01855945|E12|Reported Event|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54835|NCT01855945|E11|Reported Event|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54836|NCT01855945|E10|Reported Event|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54837|NCT01855945|E9|Reported Event|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54838|NCT01855945|E8|Reported Event|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54839|NCT01855945|E7|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54840|NCT01855945|E6|Reported Event|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54841|NCT01855945|E5|Reported Event|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54842|NCT01855945|E4|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54843|NCT01855945|E3|Reported Event|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
54844|NCT01855945|E2|Reported Event|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
54845|NCT01855945|E1|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
54846|NCT01855919|B3|Baseline|Total|Total of all reporting groups
54847|NCT01855919|B2|Baseline|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54848|NCT01855919|B1|Baseline|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54849|NCT01855919|P2|Participant Flow|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54850|NCT01855919|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54851|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54852|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54853|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54854|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54855|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54856|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54857|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54858|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54859|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54860|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during the last week.
54861|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54862|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54863|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54864|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54865|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54866|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54867|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54868|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54869|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54870|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54871|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54872|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54873|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54874|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54875|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54876|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54877|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54878|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54879|NCT01855919|E2|Reported Event|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
54880|NCT01855919|E1|Reported Event|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
54881|NCT01855074|B1|Baseline|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54882|NCT01855074|P1|Participant Flow|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54883|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54884|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54885|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54886|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54887|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54888|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54889|NCT01855074|E1|Reported Event|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
54890|NCT01854944|B4|Baseline|Total|Total of all reporting groups
54891|NCT01854944|B3|Baseline|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54892|NCT01854944|B2|Baseline|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54893|NCT01854944|B1|Baseline|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54894|NCT01854944|P3|Participant Flow|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54895|NCT01854944|P2|Participant Flow|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54896|NCT01854944|P1|Participant Flow|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1 milligram (mg) tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54897|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54898|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54899|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54900|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54901|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54902|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54903|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54904|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54905|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54906|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54907|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54908|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54909|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54910|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
102105|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
54911|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54912|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54913|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54914|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54915|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54916|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54917|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54918|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54919|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54920|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54921|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54922|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54923|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54924|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54925|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54926|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54927|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54928|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54929|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54930|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54931|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54932|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54933|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4 mg|Participants in Cohort 3 received one 1- to 4-mg dose of brexpiprazole (at the investigator’s discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54934|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in Cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54935|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in Cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54936|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54937|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54938|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54939|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54940|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54941|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54942|NCT01854944|E3|Reported Event|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54943|NCT01854944|E2|Reported Event|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
54944|NCT01854944|E1|Reported Event|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received one 1-mg of brexpiprazole once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
54945|NCT01854905|B1|Baseline|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
54946|NCT01854905|P1|Participant Flow|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
54947|NCT01854905|O1|Outcome|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
54948|NCT01854905|E1|Reported Event|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
54949|NCT01854697|B6|Baseline|Total|Total of all reporting groups
54950|NCT01854697|B5|Baseline|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54951|NCT01854697|B4|Baseline|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54952|NCT01854697|B3|Baseline|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54953|NCT01854697|B2|Baseline|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54954|NCT01854697|B1|Baseline|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54955|NCT01854697|P5|Participant Flow|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54956|NCT01854697|P4|Participant Flow|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54957|NCT01854697|P3|Participant Flow|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54958|NCT01854697|P2|Participant Flow|Arm B: TPV/PR in GT1a|Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54959|NCT01854697|P1|Participant Flow|Arm A: 3-DAA + RBV in GT1a|ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a)
54960|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54961|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54962|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54963|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54964|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54965|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54966|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54967|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54968|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54969|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54970|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54971|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54972|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54973|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54974|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54975|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54976|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54977|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54978|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54979|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54980|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54981|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54982|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54983|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54984|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54985|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54986|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54987|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54988|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54989|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54990|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
54991|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
54992|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
54993|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
54994|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
54995|NCT01854697|E3|Reported Event|TPV + PEGIFN + RBV|TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
54996|NCT01854697|E2|Reported Event|3 DAA|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks
54997|NCT01854697|E1|Reported Event|3 DAA + RBV|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks
54998|NCT01854632|B3|Baseline|Total|Total of all reporting groups
54999|NCT01854632|B2|Baseline|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
55000|NCT01854632|B1|Baseline|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
55001|NCT01854632|P2|Participant Flow|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
55002|NCT01854632|P1|Participant Flow|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
55003|NCT01854632|O2|Outcome|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
55004|NCT01854632|O1|Outcome|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
55005|NCT01854632|E2|Reported Event|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
55006|NCT01854632|E1|Reported Event|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
55007|NCT01854593|B3|Baseline|Total|Total of all reporting groups
55008|NCT01854593|B2|Baseline|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
102106|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
55009|NCT01854593|B1|Baseline|Bevacizumab and Vitrectomy|"0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55010|NCT01854593|P2|Participant Flow|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
55011|NCT01854593|P1|Participant Flow|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55012|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55013|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55014|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55015|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55016|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55017|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55018|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55019|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55020|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55021|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55022|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55023|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55024|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55025|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55026|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55027|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55028|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55029|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55030|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55031|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55032|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55033|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55034|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55035|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55036|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55064|NCT01854281|P4|Participant Flow|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after Dive B.
102107|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
55037|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55038|NCT01854593|E2|Reported Event|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
55039|NCT01854593|E1|Reported Event|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
55040|NCT01854528|B3|Baseline|Total|Total of all reporting groups
55041|NCT01854528|B2|Baseline|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55042|NCT01854528|B1|Baseline|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55043|NCT01854528|P2|Participant Flow|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55044|NCT01854528|P1|Participant Flow|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55045|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55046|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55047|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55048|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55049|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55050|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55051|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55052|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55053|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55054|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55055|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55056|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55057|NCT01854528|E2|Reported Event|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
55058|NCT01854528|E1|Reported Event|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
55059|NCT01854281|B5|Baseline|Total|Total of all reporting groups
55060|NCT01854281|B4|Baseline|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
55061|NCT01854281|B3|Baseline|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
55062|NCT01854281|B2|Baseline|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
55063|NCT01854281|B1|Baseline|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
102108|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
55065|NCT01854281|P3|Participant Flow|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
55066|NCT01854281|P2|Participant Flow|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after Dive A.
55067|NCT01854281|P1|Participant Flow|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
55068|NCT01854281|O4|Outcome|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
55069|NCT01854281|O3|Outcome|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
55070|NCT01854281|O2|Outcome|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
55071|NCT01854281|O1|Outcome|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
55072|NCT01854281|E4|Reported Event|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
55073|NCT01854281|E3|Reported Event|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
55074|NCT01854281|E2|Reported Event|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
55075|NCT01854281|E1|Reported Event|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
55076|NCT01854268|B1|Baseline|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.~Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation."
55077|NCT01854268|P1|Participant Flow|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.~Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation."
55078|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
55079|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
55080|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
55081|NCT01854268|E1|Reported Event|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times."
55082|NCT01854242|B1|Baseline|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
55083|NCT01854242|P1|Participant Flow|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
55084|NCT01854242|O1|Outcome|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
55085|NCT01854242|E1|Reported Event|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
55086|NCT01853982|B3|Baseline|Total|Total of all reporting groups
55087|NCT01853982|B2|Baseline|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
55088|NCT01853982|B1|Baseline|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
55089|NCT01853982|P2|Participant Flow|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
55090|NCT01853982|P1|Participant Flow|Ceftolozane/Tazobactam|3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
55091|NCT01853982|O2|Outcome|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
55092|NCT01853982|O1|Outcome|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
55093|NCT01853982|E2|Reported Event|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
55094|NCT01853982|E1|Reported Event|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
55095|NCT01853839|B1|Baseline|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
55096|NCT01853839|P1|Participant Flow|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
55097|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55098|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55099|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
55100|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
55101|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
55102|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
55103|NCT01853839|O2|Outcome|Internist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a internist."
55104|NCT01853839|O1|Outcome|Cardiologist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a cardiologist."
55105|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55106|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55107|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55141|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
102109|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
55108|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55109|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55110|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55111|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
55112|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
55113|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
55114|NCT01853839|E1|Reported Event|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
55115|NCT01853696|B3|Baseline|Total|Total of all reporting groups
55116|NCT01853696|B2|Baseline|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
55117|NCT01853696|B1|Baseline|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate"
55118|NCT01853696|P2|Participant Flow|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
55119|NCT01853696|P1|Participant Flow|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
55120|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
55121|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
55122|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
55123|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
55124|NCT01853696|E2|Reported Event|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
55125|NCT01853696|E1|Reported Event|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
55126|NCT01853605|B5|Baseline|Total|Total of all reporting groups
55127|NCT01853605|B4|Baseline|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
55128|NCT01853605|B3|Baseline|Reconstruction|Women undergoing breast reconstruction.
55129|NCT01853605|B2|Baseline|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
55130|NCT01853605|B1|Baseline|Augmentation|Women undergoing breast augmentation.
55131|NCT01853605|P4|Participant Flow|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
55132|NCT01853605|P3|Participant Flow|Reconstruction|Women undergoing breast reconstruction.
55133|NCT01853605|P2|Participant Flow|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
55134|NCT01853605|P1|Participant Flow|Augmentation|Women undergoing breast augmentation.
55135|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
55136|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
55137|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
55138|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
55139|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
55140|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
55145|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
55146|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
55147|NCT01853605|E4|Reported Event|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
55148|NCT01853605|E3|Reported Event|Reconstruction|Women undergoing breast reconstruction.
55149|NCT01853605|E2|Reported Event|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
55150|NCT01853605|E1|Reported Event|Augmentation|Women undergoing breast augmentation.
55151|NCT01853475|B4|Baseline|Total|Total of all reporting groups
55152|NCT01853475|B3|Baseline|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55153|NCT01853475|B2|Baseline|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55154|NCT01853475|B1|Baseline|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55155|NCT01853475|P3|Participant Flow|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55156|NCT01853475|P2|Participant Flow|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55157|NCT01853475|P1|Participant Flow|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55158|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55159|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55160|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55161|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55162|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55163|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55164|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55165|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55166|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55167|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55168|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55169|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55170|NCT01853475|E3|Reported Event|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
55171|NCT01853475|E2|Reported Event|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55172|NCT01853475|E1|Reported Event|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
55173|NCT01853397|B5|Baseline|Total|Total of all reporting groups
55174|NCT01853397|B4|Baseline|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55175|NCT01853397|B3|Baseline|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55176|NCT01853397|B2|Baseline|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55177|NCT01853397|B1|Baseline|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55178|NCT01853397|P4|Participant Flow|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55179|NCT01853397|P3|Participant Flow|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55180|NCT01853397|P2|Participant Flow|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55181|NCT01853397|P1|Participant Flow|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55182|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55183|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55184|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55185|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55186|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55187|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55188|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55189|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55190|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55191|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55192|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55193|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55194|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55195|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55196|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55197|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55198|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55199|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55200|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55201|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55202|NCT01853397|E4|Reported Event|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
55203|NCT01853397|E3|Reported Event|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
55204|NCT01853397|E2|Reported Event|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
55205|NCT01853397|E1|Reported Event|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
55206|NCT01853384|B3|Baseline|Total|Total of all reporting groups
55207|NCT01853384|B2|Baseline|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55208|NCT01853384|B1|Baseline|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55209|NCT01853384|P2|Participant Flow|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55210|NCT01853384|P1|Participant Flow|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55211|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55212|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55213|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
57662|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
55214|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55215|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55216|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55217|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55218|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55219|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55220|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55221|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55222|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55223|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55224|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55225|NCT01853384|E2|Reported Event|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
55226|NCT01853384|E1|Reported Event|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
55227|NCT01853371|B3|Baseline|Total|Total of all reporting groups
55238|NCT01853254|B1|Baseline|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
55228|NCT01853371|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55229|NCT01853371|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
55230|NCT01853371|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55231|NCT01853371|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55232|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55233|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
55234|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55235|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
55236|NCT01853371|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
55237|NCT01853371|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
55733|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55239|NCT01853254|P1|Participant Flow|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
55240|NCT01853254|O1|Outcome|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
55241|NCT01853254|E1|Reported Event|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
55242|NCT01853215|B1|Baseline|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
55243|NCT01853215|P1|Participant Flow|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55244|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55245|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55246|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55247|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55248|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
55249|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55250|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
55251|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
55252|NCT01853215|E1|Reported Event|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
55253|NCT01853176|B3|Baseline|Total|Total of all reporting groups
55254|NCT01853176|B2|Baseline|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
55255|NCT01853176|B1|Baseline|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
55256|NCT01853176|P2|Participant Flow|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
55257|NCT01853176|P1|Participant Flow|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
55258|NCT01853176|O2|Outcome|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
55259|NCT01853176|O1|Outcome|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
55260|NCT01853176|E2|Reported Event|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
55261|NCT01853176|E1|Reported Event|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
55262|NCT01853085|B1|Baseline|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55263|NCT01853085|P1|Participant Flow|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55264|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55265|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55266|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55267|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
102110|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
55268|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55269|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55270|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55271|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55272|NCT01853085|E1|Reported Event|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
55273|NCT01853072|B3|Baseline|Total|Total of all reporting groups
55274|NCT01853072|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55275|NCT01853072|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55276|NCT01853072|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55277|NCT01853072|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55278|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55279|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55280|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55281|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55282|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55283|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55284|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55285|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55286|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55287|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55288|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
55289|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
55290|NCT01853072|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
55291|NCT01853072|E3|Reported Event|Vehicle|All participants treated with NepafenacVehicle during the course of study treatment
55292|NCT01853072|E2|Reported Event|Nepafenac|All participants treated with Nepafenac during the course of study treatment
55293|NCT01853072|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
55294|NCT01852955|B3|Baseline|Total|Total of all reporting groups
55295|NCT01852955|B2|Baseline|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55296|NCT01852955|B1|Baseline|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55297|NCT01852955|P2|Participant Flow|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55298|NCT01852955|P1|Participant Flow|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55299|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55300|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55301|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55302|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55303|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55304|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55305|NCT01852955|E2|Reported Event|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
55306|NCT01852955|E1|Reported Event|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
55307|NCT01852825|B4|Baseline|Total|Total of all reporting groups
55308|NCT01852825|B3|Baseline|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55309|NCT01852825|B2|Baseline|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55310|NCT01852825|B1|Baseline|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55311|NCT01852825|P3|Participant Flow|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55312|NCT01852825|P2|Participant Flow|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55313|NCT01852825|P1|Participant Flow|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55314|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55315|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55316|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55317|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55318|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55319|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55320|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55321|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55322|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55323|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55324|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55325|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55326|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55327|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55328|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55329|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55330|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55331|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55332|NCT01852825|E3|Reported Event|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55333|NCT01852825|E2|Reported Event|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
55334|NCT01852825|E1|Reported Event|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
55335|NCT01852812|B4|Baseline|Total|Total of all reporting groups
55336|NCT01852812|B3|Baseline|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55337|NCT01852812|B2|Baseline|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55338|NCT01852812|B1|Baseline|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55339|NCT01852812|P3|Participant Flow|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55340|NCT01852812|P2|Participant Flow|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks
55341|NCT01852812|P1|Participant Flow|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55342|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55343|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55344|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55345|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55346|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55347|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55348|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55349|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55350|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55351|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55352|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55353|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55354|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55355|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55356|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55357|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55358|NCT01852812|E2|Reported Event|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
55359|NCT01852812|E1|Reported Event|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
55360|NCT01852669|B3|Baseline|Total|Total of all reporting groups
55361|NCT01852669|B2|Baseline|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55362|NCT01852669|B1|Baseline|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55363|NCT01852669|P2|Participant Flow|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55364|NCT01852669|P1|Participant Flow|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55365|NCT01852669|O2|Outcome|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55366|NCT01852669|O1|Outcome|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55367|NCT01852669|E2|Reported Event|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55368|NCT01852669|E1|Reported Event|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
55369|NCT01852591|B1|Baseline|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55370|NCT01852591|P1|Participant Flow|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55371|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55372|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55373|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55374|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55375|NCT01852591|E1|Reported Event|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
55376|NCT01852383|B1|Baseline|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
55377|NCT01852383|P1|Participant Flow|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
55378|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
55379|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
55380|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
55381|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
55382|NCT01852383|E1|Reported Event|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
55383|NCT01852214|B1|Baseline|Overall Population|Subjects with type 2 diabetes mellitus and coronary artery disease
55384|NCT01852214|P2|Participant Flow|Ticagrelor First, Then Prasugrel|"Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose~Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose"
55385|NCT01852214|P1|Participant Flow|Prasugrel First, Then Ticagrelor|"Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose~Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose"
55386|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
55387|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
55388|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
55389|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
55390|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
55391|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
55392|NCT01852214|O2|Outcome|Ticagrelor|Patients received a 180mg loading dose and 90mg bid maintenance dose
55393|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
55394|NCT01852214|E2|Reported Event|Safety Population: Patients Receiving Ticagrelor|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
55395|NCT01852214|E1|Reported Event|Safety Population: Patients Receiving Prasugrel|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
55396|NCT01852175|B3|Baseline|Total|Total of all reporting groups
55397|NCT01852175|B2|Baseline|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55398|NCT01852175|B1|Baseline|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55399|NCT01852175|P2|Participant Flow|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55400|NCT01852175|P1|Participant Flow|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55401|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55402|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55403|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55404|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55405|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55406|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55407|NCT01852175|E2|Reported Event|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
55408|NCT01852175|E1|Reported Event|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
55409|NCT01852162|B3|Baseline|Total|Total of all reporting groups
55410|NCT01852162|B2|Baseline|Placebo|Placebo tablets
55411|NCT01852162|B1|Baseline|Dabigatran|Dabigatran 150mg tablets
55412|NCT01852162|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.
55413|NCT01852162|P1|Participant Flow|Dabigatran|Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
55414|NCT01852162|O2|Outcome|Placebo|Placebo tablets
55415|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
55416|NCT01852162|O2|Outcome|Placebo|Placebo tablets
55417|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
55418|NCT01852162|O2|Outcome|Placebo|Placebo tablets
55419|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
55420|NCT01852162|O2|Outcome|Placebo|Placebo tablets
55421|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
55422|NCT01852162|O2|Outcome|Placebo|Placebo tablets
55423|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
55424|NCT01852162|E2|Reported Event|Placebo|Placebo tablets
55425|NCT01852162|E1|Reported Event|Dabigatran|Dabigatran 150mg tablets
55426|NCT01852019|B3|Baseline|Total|Total of all reporting groups
55427|NCT01852019|B2|Baseline|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55428|NCT01852019|B1|Baseline|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55429|NCT01852019|P5|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55465|NCT01851863|P4|Participant Flow|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55734|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
55430|NCT01852019|P4|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55431|NCT01852019|P3|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55432|NCT01852019|P2|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55433|NCT01852019|P1|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion|"Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55434|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55435|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55436|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55437|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55438|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55439|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55440|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55441|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55534|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55442|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55443|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55444|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55445|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
55446|NCT01852019|E5|Reported Event|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
55447|NCT01852019|E4|Reported Event|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
55448|NCT01852019|E3|Reported Event|Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]."
55449|NCT01852019|E2|Reported Event|Day 1 - Prasugrel (60mg) at 1.0 hr|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start)."
55450|NCT01852019|E1|Reported Event|Day 1 - Prasugrel (60mg) at 1.5 Hrs|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start)."
55451|NCT01851876|B3|Baseline|Total|Total of all reporting groups
55452|NCT01851876|B2|Baseline|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
55453|NCT01851876|B1|Baseline|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
55454|NCT01851876|P2|Participant Flow|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
55455|NCT01851876|P1|Participant Flow|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
55456|NCT01851876|O2|Outcome|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
55457|NCT01851876|O1|Outcome|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
55458|NCT01851876|E2|Reported Event|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
55459|NCT01851876|E1|Reported Event|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
55460|NCT01851863|B5|Baseline|Total|Total of all reporting groups
55461|NCT01851863|B4|Baseline|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55462|NCT01851863|B3|Baseline|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55463|NCT01851863|B2|Baseline|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55464|NCT01851863|B1|Baseline|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55466|NCT01851863|P3|Participant Flow|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55467|NCT01851863|P2|Participant Flow|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55468|NCT01851863|P1|Participant Flow|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55469|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55470|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55471|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55472|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55473|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55474|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55475|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55476|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55477|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55478|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55479|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55480|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole) .The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55481|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55482|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55483|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55484|NCT01851863|E4|Reported Event|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
55485|NCT01851863|E3|Reported Event|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
55486|NCT01851863|E2|Reported Event|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
55487|NCT01851863|E1|Reported Event|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
55488|NCT01851772|B1|Baseline|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55489|NCT01851772|P1|Participant Flow|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55490|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55491|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55492|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55493|NCT01851772|E1|Reported Event|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
55494|NCT01851655|B3|Baseline|Total|Total of all reporting groups
55495|NCT01851655|B2|Baseline|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55496|NCT01851655|B1|Baseline|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55497|NCT01851655|P2|Participant Flow|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55498|NCT01851655|P1|Participant Flow|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55499|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55500|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55501|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55535|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
57663|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
55502|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55503|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55504|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55505|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55506|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55507|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55508|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55509|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55510|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55536|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % Resin Lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55537|NCT01851590|E3|Reported Event|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55735|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55511|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55512|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55513|NCT01851655|E2|Reported Event|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55514|NCT01851655|E1|Reported Event|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
55515|NCT01851590|B4|Baseline|Total|Total of all reporting groups
55516|NCT01851590|B3|Baseline|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55517|NCT01851590|B2|Baseline|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine Lacquer is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55518|NCT01851590|B1|Baseline|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55519|NCT01851590|P3|Participant Flow|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine: Terbinafine 250 mg was administered orally once a day for 3 months in toenail onychomycosis."
55520|NCT01851590|P2|Participant Flow|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine: Amorolfine was administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55521|NCT01851590|P1|Participant Flow|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer was administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55522|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55523|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55524|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55525|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55526|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55527|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55528|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55529|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55530|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55531|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
55532|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55533|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55538|NCT01851590|E2|Reported Event|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
55539|NCT01851590|E1|Reported Event|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
55540|NCT01851330|B4|Baseline|Total|Total of all reporting groups
55541|NCT01851330|B3|Baseline|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55542|NCT01851330|B2|Baseline|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55543|NCT01851330|B1|Baseline|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55544|NCT01851330|P3|Participant Flow|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55545|NCT01851330|P2|Participant Flow|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55546|NCT01851330|P1|Participant Flow|LDV/SOF 8 Week|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
55547|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55548|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55549|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55550|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55551|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55552|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55553|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55554|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55555|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55556|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55557|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55558|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55559|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55560|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55561|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55562|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55563|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55564|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55565|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55566|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55567|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55568|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55569|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55570|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55571|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55572|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55573|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55574|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55575|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55576|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55577|NCT01851330|E3|Reported Event|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
55578|NCT01851330|E2|Reported Event|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
55579|NCT01851330|E1|Reported Event|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
55580|NCT01849562|B4|Baseline|Total|Total of all reporting groups
55581|NCT01849562|B3|Baseline|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
55582|NCT01849562|B2|Baseline|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55583|NCT01849562|B1|Baseline|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55584|NCT01849562|P3|Participant Flow|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
55624|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55585|NCT01849562|P2|Participant Flow|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55586|NCT01849562|P1|Participant Flow|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55587|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
55588|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55589|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55590|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
55591|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55592|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55593|NCT01849562|E3|Reported Event|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
55594|NCT01849562|E2|Reported Event|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55595|NCT01849562|E1|Reported Event|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
55596|NCT01850589|B3|Baseline|Total|Total of all reporting groups
55597|NCT01850589|B2|Baseline|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
55598|NCT01850589|B1|Baseline|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
55599|NCT01850589|P2|Participant Flow|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~8 one hour group counseling sessions focusing on patient education and behavior modification.~Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills.~Counseling includes information on nutrition, exercise, and chemical dependency.~All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer~Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
55600|NCT01850589|P1|Participant Flow|Conserative Therapy|"Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
55601|NCT01850589|O2|Outcome|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
55602|NCT01850589|O1|Outcome|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
55625|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55736|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg IVT injection
55603|NCT01850589|E2|Reported Event|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
55604|NCT01850589|E1|Reported Event|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
55605|NCT01850550|B3|Baseline|Total|Total of all reporting groups
55606|NCT01850550|B2|Baseline|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
55607|NCT01850550|B1|Baseline|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
55608|NCT01850550|P2|Participant Flow|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
55609|NCT01850550|P1|Participant Flow|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
55610|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
55611|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
55612|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
55613|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
55614|NCT01850550|E2|Reported Event|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
55615|NCT01850550|E1|Reported Event|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
55616|NCT01850485|B3|Baseline|Total|Total of all reporting groups
55617|NCT01850485|B2|Baseline|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55618|NCT01850485|B1|Baseline|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55619|NCT01850485|P2|Participant Flow|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55620|NCT01850485|P1|Participant Flow|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55621|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55622|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55623|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55626|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55627|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55628|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55629|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55630|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55631|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55632|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55633|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55634|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55635|NCT01850485|E2|Reported Event|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55636|NCT01850485|E1|Reported Event|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
55637|NCT01850394|B4|Baseline|Total|Total of all reporting groups
55638|NCT01850394|B3|Baseline|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55639|NCT01850394|B2|Baseline|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55640|NCT01850394|B1|Baseline|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55641|NCT01850394|P3|Participant Flow|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55642|NCT01850394|P2|Participant Flow|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55643|NCT01850394|P1|Participant Flow|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55644|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55645|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55646|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55647|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55648|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55649|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55650|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55651|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55652|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55653|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55730|NCT01849692|P3|Participant Flow|Cohort 2 - ESBA|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
57776|NCT01833481|B4|Baseline|Total|Total of all reporting groups
55654|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55655|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55656|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55657|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55658|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55659|NCT01850394|E3|Reported Event|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55660|NCT01850394|E2|Reported Event|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
55661|NCT01850394|E1|Reported Event|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
55662|NCT01849848|B1|Baseline|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55663|NCT01849848|P1|Participant Flow|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55664|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55665|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55666|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55667|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55668|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55669|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55670|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55671|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55672|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55673|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55731|NCT01849692|P2|Participant Flow|Cohort 1 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
55732|NCT01849692|P1|Participant Flow|Cohort 1 - ESBA|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
55674|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55675|NCT01849848|E1|Reported Event|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
55676|NCT01849770|B4|Baseline|Total|Total of all reporting groups
55677|NCT01849770|B3|Baseline|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55678|NCT01849770|B2|Baseline|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55679|NCT01849770|B1|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55680|NCT01849770|P3|Participant Flow|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55681|NCT01849770|P2|Participant Flow|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55682|NCT01849770|P1|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55683|NCT01849770|O2|Outcome|900mg vs Placebo|
55684|NCT01849770|O1|Outcome|300mg vs Placebo|
55685|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55686|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55687|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55688|NCT01849770|O2|Outcome|900mg vs Placebo|
55689|NCT01849770|O1|Outcome|300mg vs Placebo|
55690|NCT01849770|O2|Outcome|900mg vs Placebo|
55691|NCT01849770|O1|Outcome|300mg vs Placebo|
55692|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55693|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55694|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55695|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55696|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55697|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55698|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55699|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55700|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55701|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55702|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55703|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55704|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55705|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55706|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55707|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55708|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55709|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55710|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55711|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55712|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55713|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55714|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55715|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55716|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55717|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55718|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55719|NCT01849770|E3|Reported Event|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
55720|NCT01849770|E2|Reported Event|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
55721|NCT01849770|E1|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
55722|NCT01849692|B3|Baseline|Total|Total of all reporting groups
55723|NCT01849692|B2|Baseline|LUCENTIS|All subjects who were treated with LUCENTIS.
55724|NCT01849692|B1|Baseline|ESBA|All subjects who were treated with ESBA1008.
55725|NCT01849692|P8|Participant Flow|Cohort 4 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
55726|NCT01849692|P7|Participant Flow|Cohort 4 - ESBA|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
55727|NCT01849692|P6|Participant Flow|Cohort 3 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
55728|NCT01849692|P5|Participant Flow|Cohort 3 - ESBA|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
55729|NCT01849692|P4|Participant Flow|Cohort 2 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
55737|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55738|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg IVT infusion
55739|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55740|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg IVT injection
55741|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55742|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
55743|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55744|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA 1008 0.6 mg IVT injection
55745|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55746|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA 1008 1 mg IVT infusion
55747|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
55748|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA 1008 1.2 mg IVT injection
55749|NCT01849692|O4|Outcome|Cohort 4|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
55750|NCT01849692|O3|Outcome|Cohort 3|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
55751|NCT01849692|O2|Outcome|Cohort 2|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
55752|NCT01849692|O1|Outcome|Cohort 1|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
55753|NCT01849692|E7|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
55754|NCT01849692|E6|Reported Event|Stage 2 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 2
55755|NCT01849692|E5|Reported Event|Stage 2 ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg via infusion
55756|NCT01849692|E4|Reported Event|Stage 2 ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg via injection
55757|NCT01849692|E3|Reported Event|Stage 1 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 1
55758|NCT01849692|E2|Reported Event|Stage 1 ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg via infusion
55759|NCT01849692|E1|Reported Event|Stage 1 ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg via injection
55760|NCT01849497|B3|Baseline|Total|Total of all reporting groups
55761|NCT01849497|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
55762|NCT01849497|B1|Baseline|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
55763|NCT01849497|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
55764|NCT01849497|P1|Participant Flow|Evolocumab PFS|"Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).~Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4."
55765|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
55766|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
55767|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
55768|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
55769|NCT01849497|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
55770|NCT01849497|E1|Reported Event|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
55771|NCT01849419|B1|Baseline|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
55772|NCT01849419|P1|Participant Flow|Single Group|"Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.~This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant."
55773|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55774|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55775|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55776|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
102111|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
55777|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55778|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55779|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55780|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55781|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55782|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55783|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55784|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55785|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55786|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55787|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55788|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55789|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55790|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55791|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55792|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55793|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
55794|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
55795|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
55796|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
55797|NCT01849419|E1|Reported Event|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
55798|NCT01849289|B3|Baseline|Total|Total of all reporting groups
55799|NCT01849289|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55800|NCT01849289|B1|Baseline|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55801|NCT01849289|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55802|NCT01849289|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55803|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55804|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55805|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
102112|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
55806|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55807|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55808|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55809|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55810|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55811|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55812|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55813|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55814|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55815|NCT01849289|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55816|NCT01849289|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
55817|NCT01849068|B3|Baseline|Total|Total of all reporting groups
55818|NCT01849068|B2|Baseline|Placebo First Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
55819|NCT01849068|B1|Baseline|Ezetimibe First Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
55820|NCT01849068|P2|Participant Flow|Placebo First, Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
55821|NCT01849068|P1|Participant Flow|Ezetimibe First, Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
55822|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
55823|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
55824|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
55825|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
55826|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
55827|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
55828|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
55829|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
55830|NCT01849068|E2|Reported Event|Placebo|Placebo for 12 weeks Placebo for 12 weeks
55831|NCT01849068|E1|Reported Event|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
55832|NCT01848990|B4|Baseline|Total|Total of all reporting groups
55833|NCT01848990|B3|Baseline|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55951|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
55834|NCT01848990|B2|Baseline|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55835|NCT01848990|B1|Baseline|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55836|NCT01848990|P3|Participant Flow|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55837|NCT01848990|P2|Participant Flow|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55838|NCT01848990|P1|Participant Flow|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55839|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55840|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55841|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55842|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55843|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55844|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55845|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55846|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55847|NCT01848990|O2|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55848|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55849|NCT01848990|E3|Reported Event|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
55850|NCT01848990|E2|Reported Event|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55851|NCT01848990|E1|Reported Event|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
55877|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55852|NCT01848977|B1|Baseline|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
55853|NCT01848977|P1|Participant Flow|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
55854|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Reactive hyperemic area were calculated and compared to INVOS®.
55855|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Reactive hyperemic area were calculated and compared to InSpectra™ .
55856|NCT01848977|O2|Outcome|InSpectra™|Basline value before VOT,and minimum/ maximum values of InSpectra™ were obtained and compared to INVOS®.
55857|NCT01848977|O1|Outcome|INVOS®|Basline value before VOT,and minimum/ maximum values of INVOS® were obtained and compared to InSpectra™ .
55858|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
55859|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .
55860|NCT01848977|E1|Reported Event|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
55861|NCT01848938|B3|Baseline|Total|Total of all reporting groups
55862|NCT01848938|B2|Baseline|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55863|NCT01848938|B1|Baseline|Smartphone Treatment|"Smartphone treatment with pelvic floor muscle training (PFMT).~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55864|NCT01848938|P2|Participant Flow|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55865|NCT01848938|P1|Participant Flow|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55866|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55867|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55868|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55869|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55870|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55871|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55872|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55873|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55874|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55875|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55876|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55878|NCT01848938|E2|Reported Event|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
55879|NCT01848938|E1|Reported Event|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
55880|NCT01848899|B3|Baseline|Total|Total of all reporting groups
55881|NCT01848899|B2|Baseline|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55882|NCT01848899|B1|Baseline|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55883|NCT01848899|P2|Participant Flow|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55884|NCT01848899|P1|Participant Flow|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55885|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55886|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55887|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55888|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55889|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55890|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55891|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55892|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55893|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55894|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55895|NCT01848899|E2|Reported Event|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
55896|NCT01848899|E1|Reported Event|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
55897|NCT01848847|B3|Baseline|Total|Total of all reporting groups
55898|NCT01848847|B2|Baseline|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55899|NCT01848847|B1|Baseline|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55900|NCT01848847|P2|Participant Flow|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55901|NCT01848847|P1|Participant Flow|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55902|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55903|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55904|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55905|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55906|NCT01848847|E2|Reported Event|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55907|NCT01848847|E1|Reported Event|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
55908|NCT01848756|B1|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55909|NCT01848756|P1|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55910|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55911|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55912|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55913|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55914|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
55915|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
55916|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55917|NCT01848756|E1|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
55918|NCT01848366|B1|Baseline|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
55919|NCT01848366|P1|Participant Flow|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
55920|NCT01848366|O1|Outcome|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
55921|NCT01848366|E1|Reported Event|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
55922|NCT01848288|B1|Baseline|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
55923|NCT01848288|P1|Participant Flow|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
55924|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55925|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55926|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55927|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55928|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55929|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
55930|NCT01848288|E1|Reported Event|Overall|"First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, at risk population is included with unit of subjects. For ocular adverse events, at risk population is included with unit of eyes by treatment group."
55931|NCT01848210|B3|Baseline|Total|Total of all reporting groups
55932|NCT01848210|B2|Baseline|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55933|NCT01848210|B1|Baseline|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55934|NCT01848210|P2|Participant Flow|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55935|NCT01848210|P1|Participant Flow|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55936|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55937|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55938|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55939|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55940|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55941|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55942|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55943|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55944|NCT01848210|E2|Reported Event|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
55945|NCT01848210|E1|Reported Event|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
55946|NCT01848054|B3|Baseline|Total|Total of all reporting groups
55947|NCT01848054|B2|Baseline|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55948|NCT01848054|B1|Baseline|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55949|NCT01848054|P2|Participant Flow|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55950|NCT01848054|P1|Participant Flow|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55999|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55952|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55953|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55954|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55955|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55956|NCT01848054|O1|Outcome|BNX Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55957|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55958|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Day 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55959|NCT01848054|O2|Outcome|Buprenorphine Induction|"Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)~OX219 buprenorphine/naloxone: OX219 buprenorphine/naloxone sublingual tablets~Buprenorphine: Buprenorphine sublingual tablets"
55960|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55961|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55962|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55963|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55964|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55965|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55966|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55967|NCT01848054|E2|Reported Event|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55968|NCT01848054|E1|Reported Event|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
55969|NCT01847547|B3|Baseline|Total|Total of all reporting groups
55970|NCT01847547|B2|Baseline|Warfarin|Propensity score matched patients starting treatment with warfarin
55971|NCT01847547|B1|Baseline|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55972|NCT01847547|P2|Participant Flow|Warfarin|Propensity score matched patients starting treatment with warfarin
55973|NCT01847547|P1|Participant Flow|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55974|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55975|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55976|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55977|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55978|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55979|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55980|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55981|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55982|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55983|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55984|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55985|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55986|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55987|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55988|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55989|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55990|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55991|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55992|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55993|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55994|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55995|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55996|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
55997|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
55998|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
56001|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56002|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
56003|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56004|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
56005|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56006|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
56007|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56008|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
56009|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56010|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
56011|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56012|NCT01847547|E2|Reported Event|Warfarin|Propensity score matched patients starting treatment with warfarin
56013|NCT01847547|E1|Reported Event|Dabigatran|Propensity score matched patients starting treatment with dabigatran
56014|NCT01847443|B1|Baseline|Total Participants|
56015|NCT01847443|P4|Participant Flow|4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum|Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
56016|NCT01847443|P3|Participant Flow|2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum|Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
56017|NCT01847443|P2|Participant Flow|4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum|Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
56018|NCT01847443|P1|Participant Flow|2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum|Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
56019|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56020|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56021|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56022|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56023|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56024|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56025|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56026|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56027|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56028|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56029|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56030|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56031|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56032|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56033|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56034|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56035|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56036|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56037|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56038|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56039|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56040|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56041|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56042|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56043|NCT01847443|E4|Reported Event|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
56044|NCT01847443|E3|Reported Event|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
56045|NCT01847443|E2|Reported Event|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
56046|NCT01847443|E1|Reported Event|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
56047|NCT01847430|B1|Baseline|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56048|NCT01847430|P1|Participant Flow|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56049|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56050|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56051|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56052|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56053|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56054|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56055|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56056|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56057|NCT01847430|E1|Reported Event|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
56058|NCT01847196|B1|Baseline|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
56059|NCT01847196|P1|Participant Flow|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
56060|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
56061|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
56062|NCT01847196|E1|Reported Event|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
56063|NCT01847131|B3|Baseline|Total|Total of all reporting groups
56064|NCT01847131|B2|Baseline|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
56065|NCT01847131|B1|Baseline|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
56066|NCT01847131|P2|Participant Flow|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
56067|NCT01847131|P1|Participant Flow|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
56068|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
56069|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
56070|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
56071|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
56072|NCT01847131|E2|Reported Event|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
56073|NCT01847131|E1|Reported Event|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
102113|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
56074|NCT01846741|B1|Baseline|VNS Therapy (ITT Population)|Subjects who were implanted with the AspireSR® VNS Therapy® System.
56075|NCT01846741|P1|Participant Flow|VNS Therapy - ITT Population|"Subjects who were implanted with the AspireSR® VNS Therapy® System.~The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on."
56076|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
56077|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
56078|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
56079|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
56080|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
56081|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
56082|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
56083|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
56084|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
56085|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
56086|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
56087|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
56088|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
56089|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
56090|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
56091|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
56092|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
56093|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
56094|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
56095|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
56096|NCT01846741|O4|Outcome|6-Month Visit|Users' Overall Assessment of Device Usability
56097|NCT01846741|O3|Outcome|EMU Discharge|Users' Overall Assessment of Device Usability
56098|NCT01846741|O2|Outcome|EMU Day-1|Users' Overall Assessment of Device Usability
56099|NCT01846741|O1|Outcome|Implant/Recovery|Users' Overall Assessment of Device Usability
56100|NCT01846741|O1|Outcome|Number of Subjects|Experienced Adverse Events Greater Than 5% Incidence
56101|NCT01846741|O1|Outcome|VNS Therapy|ITT Population
56102|NCT01846741|O1|Outcome|AED Load|Percent Change From Baseline by Visit
56103|NCT01846741|O2|Outcome|Overall Seizure Responder Rate|Overall Seizure (All Seizure Types)
56104|NCT01846741|O1|Outcome|Partial Onset Seizure Responder Rate|Partial Onset Seizures (SPS, CPS, CPS with Secondary GTC)
56105|NCT01846741|O4|Outcome|QOLIE-31-P Scores at 18-Months|Change From Baseline at Each Category
56106|NCT01846741|O3|Outcome|QOLIE-31-P Scores at 12-Months|Change From Baseline at Each Category
56107|NCT01846741|O2|Outcome|QOLIE-31-P Scores at 6-Months|Change From Baseline at Each Category
56108|NCT01846741|O1|Outcome|QOLIE-31-P Scores at 3-Months|Change From Baseline at Each Category
56109|NCT01846741|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
56110|NCT01846741|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
56111|NCT01846741|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
56112|NCT01846741|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
56113|NCT01846741|O3|Outcome|Simple Partial Seizure (SPS)|NHS3 Scores at Follow-Up Visits
56114|NCT01846741|O2|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-up Visits
56115|NCT01846741|O1|Outcome|Complex Partial Seizure (CPS)|NHS3 Scores at Follow-Up Visits
56116|NCT01846741|O6|Outcome|Unknown Seizures|During AutoStim Course in The EMU
56117|NCT01846741|O5|Outcome|Sub-Clinical Seizures|During AutoStim Course in The EMU
56118|NCT01846741|O4|Outcome|Simple Partial Seizures|During AutoStim Course in The EMU
56119|NCT01846741|O3|Outcome|Secondary Generalized Seizures|During AutoStim Course in The EMU
56120|NCT01846741|O2|Outcome|Complex Partial Seizures|During AutoStim Course in The EMU
56121|NCT01846741|O1|Outcome|Overall Seizures|During AutoStim Course in The EMU
56122|NCT01846741|O2|Outcome|During EMU Stay Stair-Stepper Exercise|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
56123|NCT01846741|O1|Outcome|During EMU Stay|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
56124|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
56125|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
56126|NCT01846741|O3|Outcome|Total|Seizures Reported by Investigators and Triple Reviewers
56127|NCT01846741|O2|Outcome|Reported by Triple Review|EMU Seizures Identified Post EMU
56128|NCT01846741|O1|Outcome|Reported By Investigators|All Seizures Identified (During EMU)
56129|NCT01846741|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table.
56130|NCT01846455|B6|Baseline|Total|Total of all reporting groups
56131|NCT01846455|B5|Baseline|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56132|NCT01846455|B4|Baseline|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56133|NCT01846455|B3|Baseline|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56134|NCT01846455|B2|Baseline|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
58264|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
56135|NCT01846455|B1|Baseline|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56136|NCT01846455|P5|Participant Flow|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56137|NCT01846455|P4|Participant Flow|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56138|NCT01846455|P3|Participant Flow|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56139|NCT01846455|P2|Participant Flow|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56140|NCT01846455|P1|Participant Flow|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56141|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56142|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56143|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56144|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56145|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56146|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56147|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56148|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56149|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56150|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56151|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56152|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56153|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56154|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56155|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56156|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56157|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56158|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56159|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56160|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56161|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56162|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56163|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56164|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56165|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56166|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56167|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56168|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56169|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56170|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56171|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56172|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56173|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56174|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56175|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56176|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56177|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56178|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56179|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56180|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56181|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56182|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56183|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56184|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
102114|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
56185|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56186|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56187|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56188|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56189|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56190|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56191|NCT01846455|E5|Reported Event|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56192|NCT01846455|E4|Reported Event|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56193|NCT01846455|E3|Reported Event|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56194|NCT01846455|E2|Reported Event|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56195|NCT01846455|E1|Reported Event|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
56196|NCT01846416|B4|Baseline|Total|Total of all reporting groups
56197|NCT01846416|B3|Baseline|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56198|NCT01846416|B2|Baseline|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56199|NCT01846416|B1|Baseline|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56200|NCT01846416|P3|Participant Flow|Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56201|NCT01846416|P2|Participant Flow|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56202|NCT01846416|P1|Participant Flow|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced non-small cell lung cancer (NSCLC) disease received atezolizumab intravenously (IV) as a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until disease progression.
56203|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
56204|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
56205|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56206|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56207|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56249|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56332|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56208|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56209|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56210|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56211|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56212|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56213|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56214|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56215|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56216|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56217|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56218|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56219|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56220|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56221|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56222|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56223|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56224|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56225|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56226|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56279|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56280|NCT01846299|E3|Reported Event|Sham Without Ranibizumab 0.5mg|Sham without Ranibizumab 0.5mg
56227|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56228|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56229|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56230|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56231|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56232|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56233|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56234|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56235|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56236|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56237|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56238|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56239|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56240|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56241|NCT01846416|E3|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56242|NCT01846416|E2|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
56243|NCT01846416|E1|Reported Event|Atezolizumab (MPDL3280A) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
56244|NCT01846299|B3|Baseline|Total|Total of all reporting groups
56245|NCT01846299|B2|Baseline|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56246|NCT01846299|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56247|NCT01846299|P2|Participant Flow|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56248|NCT01846299|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56250|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56251|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56252|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56253|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56254|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56255|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56256|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56257|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56258|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56259|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56260|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56261|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56262|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56263|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56264|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56265|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56266|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56267|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56268|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56269|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56270|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56271|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56272|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56273|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56274|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56275|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56276|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56277|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56278|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56283|NCT01846104|B1|Baseline|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56284|NCT01846104|P1|Participant Flow|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56285|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56286|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56287|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56288|NCT01846104|E1|Reported Event|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
56289|NCT01846039|B1|Baseline|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56290|NCT01846039|P1|Participant Flow|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56291|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56292|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56293|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56294|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56295|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56296|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56297|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56298|NCT01846039|E1|Reported Event|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
56299|NCT01845155|B3|Baseline|Total|Total of all reporting groups
56300|NCT01845155|B2|Baseline|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
56301|NCT01845155|B1|Baseline|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
56302|NCT01845155|P2|Participant Flow|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
56303|NCT01845155|P1|Participant Flow|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
56304|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
56305|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
56306|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
56330|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56331|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
56396|NCT01844778|B4|Baseline|Total|Total of all reporting groups
56307|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
56308|NCT01845155|E2|Reported Event|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
56309|NCT01845155|E1|Reported Event|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
56310|NCT01845103|B1|Baseline|PEARL 8.0|
56311|NCT01845103|P1|Participant Flow|PEARL 8.0|Received TMR with PEARL 8.0
56312|NCT01845103|O1|Outcome|PEARL 8.0|
56313|NCT01845103|O1|Outcome|PEARL 8.0|
56314|NCT01845103|E1|Reported Event|PEARL 8.0|
56315|NCT01845077|B4|Baseline|Total|Total of all reporting groups
56316|NCT01845077|B3|Baseline|Total 1500 Fasted|Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56317|NCT01845077|B2|Baseline|Total 1000 Fed|Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56318|NCT01845077|B1|Baseline|Total 1000 Fasted|Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56319|NCT01845077|P6|Participant Flow|L+M1500 Fasted, Then FDC1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56320|NCT01845077|P5|Participant Flow|FDC1500 Fasted, Then L+M1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56321|NCT01845077|P4|Participant Flow|L+M1000 Fed, Then FDC1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56322|NCT01845077|P3|Participant Flow|FDC1000 Fed, Then L+M1000 Fed|1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56323|NCT01845077|P2|Participant Flow|L+M1000 Fasted, Then FDC1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56324|NCT01845077|P1|Participant Flow|FDC1000 Fasted, Then L+M1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
56325|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56326|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56327|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56328|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56329|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56564|NCT01843972|O7|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56333|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56334|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56335|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56336|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56337|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
56338|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56339|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56340|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56341|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56342|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56343|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
56344|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56345|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56346|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56347|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56348|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56349|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56350|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56351|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56352|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56353|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56354|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56355|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
56356|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56357|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56358|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56359|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56360|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56361|NCT01845077|E6|Reported Event|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
56362|NCT01845077|E5|Reported Event|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56363|NCT01845077|E4|Reported Event|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56364|NCT01845077|E3|Reported Event|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
56365|NCT01845077|E2|Reported Event|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56366|NCT01845077|E1|Reported Event|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
56367|NCT01844895|B1|Baseline|125 mg Abatacept (Autoinjector and Prefilled Syringe)|Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
56368|NCT01844895|P1|Participant Flow|125 mg Abatacept (Autoinjector and Prefilled Syringe)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
56369|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector- Day 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
56370|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56371|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
56372|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56373|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
56374|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56375|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
56376|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56377|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
56378|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56379|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector - Day 113|125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
56380|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
56381|NCT01844895|E2|Reported Event|Abatacept Cumulative (Prefilled Syringe and Autoinjector)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
56382|NCT01844895|E1|Reported Event|Abatacept Via Autoinjector Only (Day 29 to End of Study)|Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
56383|NCT01844856|B3|Baseline|Total|Total of all reporting groups
56384|NCT01844856|B2|Baseline|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
56385|NCT01844856|B1|Baseline|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
56386|NCT01844856|P2|Participant Flow|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
56387|NCT01844856|P1|Participant Flow|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
56388|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
56389|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
56390|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
56391|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
56392|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
56393|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
56394|NCT01844856|E2|Reported Event|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
56395|NCT01844856|E1|Reported Event|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
56397|NCT01844778|B3|Baseline|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56398|NCT01844778|B2|Baseline|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56399|NCT01844778|B1|Baseline|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56400|NCT01844778|P3|Participant Flow|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56401|NCT01844778|P2|Participant Flow|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56402|NCT01844778|P1|Participant Flow|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56403|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56404|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56405|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56406|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56407|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56408|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56409|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56410|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56411|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56412|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56413|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56414|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56415|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56416|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56417|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56418|NCT01844778|E7|Reported Event|Overall TIP Cycle 2|During the second cycle, each treatment group received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
58265|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
56419|NCT01844778|E6|Reported Event|TIP/TIP - Cycle 2|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56420|NCT01844778|E5|Reported Event|TIP/TIP - Cycle 1|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56421|NCT01844778|E4|Reported Event|COLI/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56422|NCT01844778|E3|Reported Event|COLI/TIP - Cycle 1|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines.
56423|NCT01844778|E2|Reported Event|TIS/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
56424|NCT01844778|E1|Reported Event|TIS/TIP - Cycle 1|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment.
56425|NCT01844700|B3|Baseline|Total|Total of all reporting groups
56426|NCT01844700|B2|Baseline|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 patients were randomized to usual care"
56427|NCT01844700|B1|Baseline|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 patients were randomized to Ziprasidone"
56428|NCT01844700|P2|Participant Flow|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants"
56429|NCT01844700|P1|Participant Flow|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants"
56430|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
56431|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
56432|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
56433|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
56434|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
56435|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
56436|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
56437|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
56438|NCT01844700|E2|Reported Event|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes~there were no serious adverse events in this group"
56439|NCT01844700|E1|Reported Event|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes~there were no serious adverse events in this group"
56440|NCT01844531|B5|Baseline|Total|Total of all reporting groups
56441|NCT01844531|B4|Baseline|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
56442|NCT01844531|B3|Baseline|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
56471|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56443|NCT01844531|B2|Baseline|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|"Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC).~Oral administration."
56444|NCT01844531|B1|Baseline|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|"Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets).~Oral administration."
56445|NCT01844531|P4|Participant Flow|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
56446|NCT01844531|P3|Participant Flow|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
56447|NCT01844531|P2|Participant Flow|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). Oral administration.
56448|NCT01844531|P1|Participant Flow|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin Fixed Dose Combination (FDC)). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
56449|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56450|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56451|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56452|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56453|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56454|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56455|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56456|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56457|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56458|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56459|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56460|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56461|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56462|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56463|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56464|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56465|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56466|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56467|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56468|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56469|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56470|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56472|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56473|NCT01844531|E4|Reported Event|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56474|NCT01844531|E3|Reported Event|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56475|NCT01844531|E2|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
56476|NCT01844531|E1|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
56477|NCT01844518|B1|Baseline|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56478|NCT01844518|P1|Participant Flow|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56479|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56480|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56481|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56482|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56483|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56484|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56485|NCT01844518|O3|Outcome|>=50 kg Dosing Group|Weight-tiered dosing group receiving 125 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56486|NCT01844518|O2|Outcome|25 to <50 kg Dosing Group|Weight-tiered dosing group receiving 87.5 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56487|NCT01844518|O1|Outcome|10 to <25 kg Dosing Group|Weight-tiered dosing group receiving 50 milligrams (mg) subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56488|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
56489|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56490|NCT01844518|E1|Reported Event|SC Abatacept Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
56491|NCT01844479|B1|Baseline|All Study Participants|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
56492|NCT01844479|P2|Participant Flow|Diabetic Foot Orthotic Followed by Standard Innersole|"The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56506|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56493|NCT01844479|P1|Participant Flow|Standard Innersole Followed by DFO|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
56494|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56495|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56496|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56497|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56498|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56499|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56500|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56501|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56502|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56503|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56504|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56505|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56507|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56508|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56509|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56510|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56511|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56512|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56513|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56514|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56515|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56516|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56517|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56518|NCT01844479|E2|Reported Event|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
56519|NCT01844479|E1|Reported Event|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
56520|NCT01844388|B3|Baseline|Total|Total of all reporting groups
56521|NCT01844388|B2|Baseline|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56522|NCT01844388|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56523|NCT01844388|P2|Participant Flow|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56524|NCT01844388|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56525|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56526|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56527|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56528|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56529|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56530|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56531|NCT01844388|E2|Reported Event|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56532|NCT01844388|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
56533|NCT01844206|B3|Baseline|Total|Total of all reporting groups
56534|NCT01844206|B2|Baseline|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
56535|NCT01844206|B1|Baseline|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
56536|NCT01844206|P2|Participant Flow|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
56537|NCT01844206|P1|Participant Flow|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
56538|NCT01844206|O2|Outcome|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
56539|NCT01844206|O1|Outcome|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
56540|NCT01844206|E2|Reported Event|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
56541|NCT01844206|E1|Reported Event|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
56542|NCT01843972|B11|Baseline|Total|Total of all reporting groups
56543|NCT01843972|B10|Baseline|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56544|NCT01843972|B9|Baseline|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
56545|NCT01843972|B8|Baseline|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56546|NCT01843972|B7|Baseline|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56547|NCT01843972|B6|Baseline|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56548|NCT01843972|B5|Baseline|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56549|NCT01843972|B4|Baseline|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56550|NCT01843972|B3|Baseline|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56551|NCT01843972|B2|Baseline|BI 691751dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56552|NCT01843972|B1|Baseline|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
56553|NCT01843972|P10|Participant Flow|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56554|NCT01843972|P9|Participant Flow|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
56555|NCT01843972|P8|Participant Flow|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56556|NCT01843972|P7|Participant Flow|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56557|NCT01843972|P6|Participant Flow|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56558|NCT01843972|P5|Participant Flow|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56559|NCT01843972|P4|Participant Flow|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56560|NCT01843972|P3|Participant Flow|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56561|NCT01843972|P2|Participant Flow|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56562|NCT01843972|P1|Participant Flow|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
56563|NCT01843972|O8|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56565|NCT01843972|O6|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56566|NCT01843972|O5|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56567|NCT01843972|O4|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56568|NCT01843972|O3|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56569|NCT01843972|O2|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56570|NCT01843972|O1|Outcome|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
56571|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56572|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56573|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56574|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56575|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56576|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56577|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56578|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56579|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56580|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56581|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56582|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56583|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56584|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56585|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56586|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56587|NCT01843972|O10|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56588|NCT01843972|O9|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
56589|NCT01843972|O8|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
56590|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56591|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56592|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56593|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56594|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56595|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56596|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56597|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56598|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56599|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56600|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56601|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56602|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56603|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56604|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56702|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56703|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56605|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56606|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56607|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56608|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56609|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56610|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56611|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56612|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56613|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56614|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
56615|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
56616|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56617|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|"single dose given as 1 tablet; poor metabolizers;~BI 691751: 1 tablet (10 mg)"
56618|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|"single dose given as 1 tablet; extensive metabolizers;~BI 691751: 1 tablet (10 mg)"
56619|NCT01843972|E10|Reported Event|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
56620|NCT01843972|E9|Reported Event|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
56621|NCT01843972|E8|Reported Event|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
56622|NCT01843972|E7|Reported Event|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
56623|NCT01843972|E6|Reported Event|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
56624|NCT01843972|E5|Reported Event|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
56625|NCT01843972|E4|Reported Event|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
56626|NCT01843972|E3|Reported Event|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
56627|NCT01843972|E2|Reported Event|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
56628|NCT01843972|E1|Reported Event|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
56629|NCT01843933|B3|Baseline|Total|Total of all reporting groups
56630|NCT01843933|B2|Baseline|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
56631|NCT01843933|B1|Baseline|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
56632|NCT01843933|P2|Participant Flow|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
56633|NCT01843933|P1|Participant Flow|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
56634|NCT01843933|O2|Outcome|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
56635|NCT01843933|O1|Outcome|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
56636|NCT01843933|E2|Reported Event|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
56704|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
102115|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
56637|NCT01843933|E1|Reported Event|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
56638|NCT01843920|B3|Baseline|Total|Total of all reporting groups
56639|NCT01843920|B2|Baseline|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56640|NCT01843920|B1|Baseline|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56641|NCT01843920|P2|Participant Flow|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56642|NCT01843920|P1|Participant Flow|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56643|NCT01843920|O2|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56644|NCT01843920|O1|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56645|NCT01843920|E2|Reported Event|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56646|NCT01843920|E1|Reported Event|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
56647|NCT01843777|B3|Baseline|Total|Total of all reporting groups
56648|NCT01843777|B2|Baseline|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
56649|NCT01843777|B1|Baseline|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
56650|NCT01843777|P2|Participant Flow|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
56651|NCT01843777|P1|Participant Flow|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
56652|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
56653|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
56654|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
56705|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56655|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
56656|NCT01843777|E2|Reported Event|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
56657|NCT01843777|E1|Reported Event|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
56658|NCT01843673|B1|Baseline|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
56659|NCT01843673|P1|Participant Flow|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART"
56660|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56661|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56662|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56663|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56664|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56665|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56666|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56667|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56668|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
56669|NCT01843673|E1|Reported Event|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
56670|NCT01843660|B1|Baseline|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56671|NCT01843660|P1|Participant Flow|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56672|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56673|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56674|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56675|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56676|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56677|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56678|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56679|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56680|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56681|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56682|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56683|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56684|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56685|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56686|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56687|NCT01843660|E1|Reported Event|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
56688|NCT01843465|B1|Baseline|Cryoablation of Atrial Fibrillation|Maneuvers for documenting the disconnection :
56689|NCT01843465|P1|Participant Flow|Cryoablation of Atrial Fibrillation|"All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.~According to the maneuvers for documenting the disconnection , 4 PV types were defined:~Type 1 - Achieve allowing documentation of PV disconnection in the standard position.~Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application.~Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection"
56690|NCT01843465|O1|Outcome|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
56691|NCT01843465|E1|Reported Event|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
56692|NCT01843192|B4|Baseline|Total|Total of all reporting groups
56693|NCT01843192|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56694|NCT01843192|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy
56695|NCT01843192|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection
56696|NCT01843192|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56697|NCT01843192|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy
56698|NCT01843192|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection
56699|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56700|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56701|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56706|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56708|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56709|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56710|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56711|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56712|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56713|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56714|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56715|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56716|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56717|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56718|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56719|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56720|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56721|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
56722|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
56723|NCT01843192|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
56724|NCT01843192|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
56725|NCT01843192|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
56726|NCT01842841|B1|Baseline|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56727|NCT01842841|P1|Participant Flow|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 units per kilogram (U/kg), every other week (EOW) administered as an intravenous (IV) infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56728|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56729|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56730|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56731|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56732|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56733|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56734|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56735|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56736|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56737|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56738|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56739|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56740|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56741|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56742|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56743|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56744|NCT01842841|E1|Reported Event|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
56768|NCT01842594|E1|Reported Event|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
102116|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
56745|NCT01842607|B1|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56746|NCT01842607|P1|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56747|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56748|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56749|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56750|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56751|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56752|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56753|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56754|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56755|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56756|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56757|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56758|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56759|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56760|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56761|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56762|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56763|NCT01842607|E1|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
56764|NCT01842594|B1|Baseline|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
56765|NCT01842594|P1|Participant Flow|Sirolimus and Hydroxychloroquine|Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks.
56766|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
56767|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
56773|NCT01842464|O1|Outcome|Anterior Sacro-Spinous Support|Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
56774|NCT01842464|E1|Reported Event|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
56775|NCT01842438|B3|Baseline|Total|Total of all reporting groups
56776|NCT01842438|B2|Baseline|Control|This group will not receive the intervention during the life-span of the project
56777|NCT01842438|B1|Baseline|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
56778|NCT01842438|P2|Participant Flow|Control|This group will not receive the intervention during the life-span of the project
56779|NCT01842438|P1|Participant Flow|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
56780|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
56781|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
56782|NCT01842438|O4|Outcome|Control: Partners|Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
56783|NCT01842438|O3|Outcome|Control: Patient Group|Did not receive the intervention. All males
56784|NCT01842438|O2|Outcome|Intervention: Partners|This group received the intervention during the life-span of the project. Partners only.
56785|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention PATIENTS|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention~This data is patients-only (all males)"
56786|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
56787|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
56788|NCT01842438|E2|Reported Event|Control|This group will not receive the intervention during the life-span of the project
56789|NCT01842438|E1|Reported Event|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
56790|NCT01841970|B1|Baseline|HET Arm|"Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids~HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply."
56791|NCT01841970|P1|Participant Flow|HET Arm|All subjects enrolled into the study were treated with the HET Bipolar System
56792|NCT01841970|O3|Outcome|Month 6|
56793|NCT01841970|O2|Outcome|Month 3|
56794|NCT01841970|O1|Outcome|Month 1|
56795|NCT01841970|O3|Outcome|Month 6|
56796|NCT01841970|O2|Outcome|Month 3|
56797|NCT01841970|O1|Outcome|Month 1|
56798|NCT01841970|O3|Outcome|Month 6|
56799|NCT01841970|O2|Outcome|Month 3|
56800|NCT01841970|O1|Outcome|Month 1|
56801|NCT01841970|O3|Outcome|Month 6|
56802|NCT01841970|O2|Outcome|Month 3|
56803|NCT01841970|O1|Outcome|Month 1|
56804|NCT01841970|O1|Outcome|HET Arm|
56805|NCT01841970|E1|Reported Event|HET Arm|
56806|NCT01841697|B3|Baseline|Total|Total of all reporting groups
56807|NCT01841697|B2|Baseline|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56808|NCT01841697|B1|Baseline|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56809|NCT01841697|P2|Participant Flow|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56810|NCT01841697|P1|Participant Flow|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56811|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56812|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56813|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56814|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56858|NCT01841216|B2|Baseline|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
102117|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
56815|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56816|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56817|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56818|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56819|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56820|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56821|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56822|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56823|NCT01841697|E2|Reported Event|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56824|NCT01841697|E1|Reported Event|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
56825|NCT01841619|B1|Baseline|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56826|NCT01841619|P1|Participant Flow|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56827|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56828|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56859|NCT01841216|B1|Baseline|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56860|NCT01841216|P2|Participant Flow|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56829|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56830|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56831|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56832|NCT01841619|E1|Reported Event|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
56833|NCT01841593|B3|Baseline|Total|Total of all reporting groups
56834|NCT01841593|B2|Baseline|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
56835|NCT01841593|B1|Baseline|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
56836|NCT01841593|P2|Participant Flow|Group B (Amlodipine Then Raltegravir)|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
56837|NCT01841593|P1|Participant Flow|Group A (Raltegravir Then Amlodipine)|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
56838|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56839|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56840|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56841|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56842|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56843|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56844|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56845|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56846|NCT01841593|O4|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56847|NCT01841593|O3|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56848|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56849|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
56850|NCT01841593|E2|Reported Event|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
56851|NCT01841593|E1|Reported Event|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
56852|NCT01841567|B1|Baseline|Dressing|"Mepilex border post. op~Mepilex border post op"
56853|NCT01841567|P1|Participant Flow|Dressing|"Mepilex border post. op~Mepilex border post op"
56854|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
56855|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
56856|NCT01841567|E1|Reported Event|Dressing|"Mepilex border post. op~Mepilex border post op"
56857|NCT01841216|B3|Baseline|Total|Total of all reporting groups
56896|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56861|NCT01841216|P1|Participant Flow|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56862|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56863|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56864|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56865|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56866|NCT01841216|E2|Reported Event|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56867|NCT01841216|E1|Reported Event|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
56868|NCT01841021|B1|Baseline|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56869|NCT01841021|P1|Participant Flow|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56870|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56871|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56872|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56873|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56874|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56875|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56876|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56877|NCT01841021|E1|Reported Event|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
56878|NCT01840943|B3|Baseline|Total|Total of all reporting groups
56879|NCT01840943|B2|Baseline|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56880|NCT01840943|B1|Baseline|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56881|NCT01840943|P2|Participant Flow|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56882|NCT01840943|P1|Participant Flow|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56883|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56884|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56885|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56886|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56887|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56888|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56889|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56890|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56891|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56892|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56893|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56894|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56895|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56897|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56898|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56899|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56900|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56901|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56902|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56903|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56904|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56905|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56906|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56907|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56908|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56909|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56910|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56911|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56912|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56913|NCT01840943|E2|Reported Event|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
56914|NCT01840943|E1|Reported Event|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
56915|NCT01840605|B3|Baseline|Total|Total of all reporting groups
56916|NCT01840605|B2|Baseline|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
56917|NCT01840605|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
56918|NCT01840605|P2|Participant Flow|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
56919|NCT01840605|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
56920|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
56921|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
56922|NCT01840605|E2|Reported Event|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
56923|NCT01840605|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
56924|NCT01840410|B3|Baseline|Total|Total of all reporting groups
56925|NCT01840410|B2|Baseline|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56926|NCT01840410|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56927|NCT01840410|P2|Participant Flow|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56928|NCT01840410|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56929|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56930|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56931|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56932|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56933|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56934|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56935|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
57136|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
56936|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56937|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56938|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56939|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56940|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56941|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56942|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56943|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56944|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56945|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56946|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56947|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56948|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56949|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56950|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56951|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56952|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56953|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56954|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56955|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56956|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56957|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56958|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
56959|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56960|NCT01840410|E3|Reported Event|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
56961|NCT01840410|E2|Reported Event|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
56962|NCT01840410|E1|Reported Event|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
56963|NCT01840319|B1|Baseline|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
56984|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
56964|NCT01840319|P1|Participant Flow|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
56965|NCT01840319|O1|Outcome|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
56966|NCT01840319|E1|Reported Event|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
56967|NCT01840072|B3|Baseline|Total|Total of all reporting groups
56968|NCT01840072|B2|Baseline|Usual Care|Discontinue all home BP medications.
56969|NCT01840072|B1|Baseline|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56970|NCT01840072|P2|Participant Flow|Usual Care|Discontinue all home BP medications.
56971|NCT01840072|P1|Participant Flow|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56972|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56973|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
56974|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
56975|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56976|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
56977|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56978|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56979|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
56980|NCT01840072|E2|Reported Event|Usual Care|Discontinue all home BP medications.
56981|NCT01840072|E1|Reported Event|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
56982|NCT01839695|B1|Baseline|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
56983|NCT01839695|P1|Participant Flow|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
57129|NCT01838590|B5|Baseline|Total|Total of all reporting groups
56985|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
56986|NCT01839695|E1|Reported Event|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
56987|NCT01839318|B1|Baseline|Overall|Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
56988|NCT01839318|P6|Participant Flow|Sequence 6|Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56989|NCT01839318|P5|Participant Flow|Sequence 5|Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56990|NCT01839318|P4|Participant Flow|Sequence 4|Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56991|NCT01839318|P3|Participant Flow|Sequence 3|Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56992|NCT01839318|P2|Participant Flow|Sequence 2|Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56993|NCT01839318|P1|Participant Flow|Sequence 1|Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
56994|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
56995|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
56996|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
56997|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
56998|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
56999|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
57000|NCT01839318|E3|Reported Event|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
57001|NCT01839318|E2|Reported Event|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
57002|NCT01839318|E1|Reported Event|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
57003|NCT01839279|B4|Baseline|Total|Total of all reporting groups
57004|NCT01839279|B3|Baseline|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
57005|NCT01839279|B2|Baseline|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
57006|NCT01839279|B1|Baseline|Tizanidine|
57007|NCT01839279|P3|Participant Flow|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
57008|NCT01839279|P2|Participant Flow|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
57009|NCT01839279|P1|Participant Flow|Tizanidine|
57010|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
57011|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
57012|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
57013|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
57014|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
57015|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
57016|NCT01839279|O1|Outcome|Tizanidine|
57017|NCT01839279|O3|Outcome|Tizanidine 8 mg Placebo-corrected|70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
57018|NCT01839279|O2|Outcome|Tizanidine Placebo 8 mg|63 subjects placebo used for analysis.
57019|NCT01839279|O1|Outcome|Tizanidine 8 mg|70 subjects Tizanidine 8 mg single dose.
57020|NCT01839279|O3|Outcome|Tizanidine 24 mg Placebo-corrected|60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
57021|NCT01839279|O2|Outcome|Tizanidine Placebo 24 mg|61 subjects placebo used for the analysis.
57022|NCT01839279|O1|Outcome|Tizanidine 24 mg|60 subjects Tizanidine 24 mg single dose
57023|NCT01839279|E4|Reported Event|Placebo and Moxifloxacin Groups Combined|
57024|NCT01839279|E3|Reported Event|Initial Moxifloxacin and Crossover to Placebo|
57025|NCT01839279|E2|Reported Event|Initial Placebo and Crossover to Moxifloxacin|
57026|NCT01839279|E1|Reported Event|Tizanidine|
57027|NCT01838980|B1|Baseline|Colonoscopy|Motus GI Clean-Up Device
57028|NCT01838980|P1|Participant Flow|Colonoscopy|Motus GI Clean-Up Device
57029|NCT01838980|O1|Outcome|Colonoscopy|Motus GI Clean-Up Device
57030|NCT01838980|E1|Reported Event|Colonoscopy|Motus GI Clean-Up Device
57031|NCT01838941|B1|Baseline|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
57032|NCT01838941|P1|Participant Flow|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
57130|NCT01838590|B4|Baseline|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
57131|NCT01838590|B3|Baseline|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
57033|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
57034|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
57035|NCT01838941|E1|Reported Event|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
57036|NCT01838694|B3|Baseline|Total|Total of all reporting groups
57037|NCT01838694|B2|Baseline|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57038|NCT01838694|B1|Baseline|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
57039|NCT01838694|P2|Participant Flow|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57040|NCT01838694|P1|Participant Flow|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
57041|NCT01838694|O5|Outcome|Ala-Cpn10 - 30mgs in Moderate SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57042|NCT01838694|O4|Outcome|Ala-Cpn10 - 100mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57043|NCT01838694|O3|Outcome|Ala-Cpn10 - 30mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57044|NCT01838694|O2|Outcome|Ala-Cpn10 - 10mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57045|NCT01838694|O1|Outcome|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
57046|NCT01838694|E2|Reported Event|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg [10mg twice weekly] to 5mg/kg [300mg twice weekly]) administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
57047|NCT01838694|E1|Reported Event|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
57048|NCT01838642|B1|Baseline|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57049|NCT01838642|P1|Participant Flow|RET Mutation Positive Participants.|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57050|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57051|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57052|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57053|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57054|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57055|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57056|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57057|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
58266|NCT01830855|O2|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
57058|NCT01838642|E1|Reported Event|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
57059|NCT01838616|B3|Baseline|Total|Total of all reporting groups
57060|NCT01838616|B2|Baseline|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57061|NCT01838616|B1|Baseline|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57062|NCT01838616|P2|Participant Flow|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57063|NCT01838616|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57064|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57065|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57066|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57067|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57068|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57069|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57070|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57071|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57072|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57132|NCT01838590|B2|Baseline|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
57073|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57074|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57075|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57076|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57077|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57078|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57079|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57080|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57081|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57082|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57083|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57084|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57085|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57086|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57133|NCT01838590|B1|Baseline|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
58267|NCT01830855|O1|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
57087|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57088|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57089|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57090|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57091|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57092|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57093|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57094|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57095|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57096|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57097|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57098|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57099|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57100|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57134|NCT01838590|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
58268|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
57101|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57102|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57103|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57104|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57105|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57106|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57107|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57108|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57109|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57110|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57111|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57112|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57113|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57114|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57135|NCT01838590|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
102118|NCT01587079|O7|Outcome|FF MDI 9.6 μg|9.6 μg
57115|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57116|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57117|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57118|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57119|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57120|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57121|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57122|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57123|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57124|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57125|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
57126|NCT01838616|E3|Reported Event|Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment|Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
57127|NCT01838616|E2|Reported Event|Oxycodone/Naloxone Prolonged Release (PR)|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57128|NCT01838616|E1|Reported Event|Tapentadol Prolonged Release (PR)|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
57137|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
57138|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
57139|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
57140|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
57141|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
57142|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
57143|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
57144|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
57145|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
57146|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
57147|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
57148|NCT01838590|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
57149|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
57150|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
57151|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
57152|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
57153|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
57154|NCT01838590|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
57155|NCT01838590|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
57156|NCT01838499|B3|Baseline|Total|Total of all reporting groups
57157|NCT01838499|B2|Baseline|Saline|SC injection
57158|NCT01838499|B1|Baseline|MEDI8968|SC injection
57159|NCT01838499|P2|Participant Flow|Saline|SC injection
57160|NCT01838499|P1|Participant Flow|MEDI8968|SC injection
57161|NCT01838499|O2|Outcome|Saline|SC injection
57162|NCT01838499|O1|Outcome|MEDI8968|SC injection
57163|NCT01838499|O2|Outcome|Saline|SC injection
57164|NCT01838499|O1|Outcome|MEDI8968|SC injection
57165|NCT01838499|O2|Outcome|Saline|SC injection
57166|NCT01838499|O1|Outcome|MEDI8968|SC injection
57167|NCT01838499|E2|Reported Event|Saline|SC injection
57168|NCT01838499|E1|Reported Event|MEDI8968|SC injection
57169|NCT01838213|B3|Baseline|Total|Total of all reporting groups
57170|NCT01838213|B2|Baseline|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
57171|NCT01838213|B1|Baseline|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
57172|NCT01838213|P2|Participant Flow|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
57173|NCT01838213|P1|Participant Flow|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
57174|NCT01838213|O2|Outcome|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
57175|NCT01838213|O1|Outcome|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
57176|NCT01838213|E2|Reported Event|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
57177|NCT01838213|E1|Reported Event|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
57178|NCT01838044|B3|Baseline|Total|Total of all reporting groups
57179|NCT01838044|B2|Baseline|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57180|NCT01838044|B1|Baseline|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
58269|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
57181|NCT01838044|P2|Participant Flow|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57182|NCT01838044|P1|Participant Flow|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57183|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57184|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57185|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57186|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57187|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57188|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57189|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57235|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57236|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57598|NCT01835015|B1|Baseline|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57190|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57191|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57192|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57193|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57194|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57195|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57196|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57197|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57198|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57237|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57238|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57239|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57199|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57200|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57201|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57202|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57203|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57204|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57205|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57206|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57207|NCT01838044|O1|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57240|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57241|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57599|NCT01835015|P5|Participant Flow|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57208|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57209|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57210|NCT01838044|E2|Reported Event|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57211|NCT01838044|E1|Reported Event|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
57212|NCT01837966|B3|Baseline|Total|Total of all reporting groups
57213|NCT01837966|B2|Baseline|Placebo|"Placebo - unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
57214|NCT01837966|B1|Baseline|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
57215|NCT01837966|P2|Participant Flow|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
57216|NCT01837966|P1|Participant Flow|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
57217|NCT01837966|O2|Outcome|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
57218|NCT01837966|O1|Outcome|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
57219|NCT01837966|E2|Reported Event|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
57220|NCT01837966|E1|Reported Event|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
57221|NCT01837797|B4|Baseline|Total|Total of all reporting groups
57222|NCT01837797|B3|Baseline|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
57223|NCT01837797|B2|Baseline|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
57224|NCT01837797|B1|Baseline|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57225|NCT01837797|P5|Participant Flow|Period 3 Placebo and ADT|"Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)~Placebo: Once daily, tablets, orally"
57226|NCT01837797|P4|Participant Flow|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57227|NCT01837797|P3|Participant Flow|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57228|NCT01837797|P2|Participant Flow|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57229|NCT01837797|P1|Participant Flow|Period 1 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57230|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57231|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57232|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57233|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57234|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57422|NCT01836042|P1|Participant Flow|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
57242|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57243|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57244|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57245|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57246|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57247|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57248|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57249|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57250|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57251|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57252|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57253|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57254|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57255|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57256|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57257|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
57258|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
57259|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57260|NCT01837797|E3|Reported Event|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
57261|NCT01837797|E2|Reported Event|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
57262|NCT01837797|E1|Reported Event|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
57263|NCT01837719|B1|Baseline|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 29. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
57264|NCT01837719|P1|Participant Flow|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
57265|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57266|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57267|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57268|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57269|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57423|NCT01836042|O3|Outcome|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
57270|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
57271|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
57272|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57273|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57274|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57275|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
57276|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57277|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57278|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57279|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57280|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
57281|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or22
57282|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57283|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57284|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57285|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57286|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57287|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57288|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57289|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57290|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57291|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57292|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57293|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57294|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57295|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57296|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
57297|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57298|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57299|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57300|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57301|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57302|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57303|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57304|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57305|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57306|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57307|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57308|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57309|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57310|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57311|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57312|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57313|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57314|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57315|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57316|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57317|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57318|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57319|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57320|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
57321|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
57322|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
57323|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
57324|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
57325|NCT01837719|E5|Reported Event|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
57326|NCT01837719|E4|Reported Event|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22.
57327|NCT01837719|E3|Reported Event|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22.
57328|NCT01837719|E2|Reported Event|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8.
57329|NCT01837719|E1|Reported Event|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8.
57330|NCT01837550|B3|Baseline|Total|Total of all reporting groups
57331|NCT01837550|B2|Baseline|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57332|NCT01837550|B1|Baseline|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57333|NCT01837550|P2|Participant Flow|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57364|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57365|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
57660|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57334|NCT01837550|P1|Participant Flow|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57335|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57336|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57337|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57338|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57339|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57340|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57341|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57342|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57343|NCT01837550|E2|Reported Event|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
57344|NCT01837550|E1|Reported Event|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
57345|NCT01837537|B1|Baseline|no Treatment|no treatment, prospective observational
57346|NCT01837537|P1|Participant Flow|no Treatment|no treatment, prospective observational
57347|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
57348|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
57349|NCT01837537|E1|Reported Event|no Treatment|no treatment, prospective observational
57350|NCT01836809|B5|Baseline|Total|Total of all reporting groups
57351|NCT01836809|B4|Baseline|LVAD: Placebo|"Control arm of the LVAD group~randomized to placebo"
57352|NCT01836809|B3|Baseline|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to nesiritide"
57353|NCT01836809|B2|Baseline|Total Artificial Heart: Placebo|"Total Artificial Heart group~randomized to placebo"
57354|NCT01836809|B1|Baseline|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to nesiritide"
57355|NCT01836809|P4|Participant Flow|LVAD: Placebo|This arm will consist of subjects who received an LVAD and will be randomized to placebo
57356|NCT01836809|P3|Participant Flow|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
57357|NCT01836809|P2|Participant Flow|Total Artificial Heart: Placebo|This arm included subject who received a total artificial heart and will be randomized receive placebo
57358|NCT01836809|P1|Participant Flow|Total Artificial Heart|"Active arm of Total Artificial Heart group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
57359|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
57360|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57361|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
57362|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57363|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
57424|NCT01836042|O2|Outcome|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
57366|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57367|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
57368|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57369|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
57370|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57371|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
57372|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57373|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
57374|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57375|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
57376|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57377|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
57378|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
57379|NCT01836809|O4|Outcome|LVAD: Placebo|"Active arm of the LVAD group~randomized to receive placebo"
57380|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide"
57381|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
57382|NCT01836809|O1|Outcome|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide"
57383|NCT01836809|E4|Reported Event|LVAD: Placebo|"Control arm of the LVAD group~randomized to receive placebo"
57384|NCT01836809|E3|Reported Event|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
57385|NCT01836809|E2|Reported Event|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
57386|NCT01836809|E1|Reported Event|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide 0.005 mcg/kg/min without bolus"
57387|NCT01836458|B5|Baseline|Total|Total of all reporting groups
57388|NCT01836458|B4|Baseline|Dose 4: 15 mg|Single dose of KAE609 15 mg
57389|NCT01836458|B3|Baseline|Dose 3: 10 mg|Single dose of KAE609 10 mg
57390|NCT01836458|B2|Baseline|Dose 2: 20 mg|Single dose of KAE609 20 mg
57391|NCT01836458|B1|Baseline|Dose 1: 30 mg|Single dose of KAE609 30 mg
57392|NCT01836458|P4|Participant Flow|Dose 4: 15 mg|Single dose of KAE609 15 mg
57393|NCT01836458|P3|Participant Flow|Dose 3: 10 mg|Single dose of KAE609 10 mg
57394|NCT01836458|P2|Participant Flow|Dose 2: 20 mg|Single dose of KAE609 20 mg
57395|NCT01836458|P1|Participant Flow|Dose 1: 30 mg|Single dose of KAE609 30 mg
57396|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
57397|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
57398|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
57399|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
57400|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
57401|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
57402|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
57403|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
57404|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
57405|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
57406|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
57407|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
57408|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
57409|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
57410|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
57411|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
57412|NCT01836458|E4|Reported Event|Dose 4: 15mg|Single dose of KAE609 15 mg
57413|NCT01836458|E3|Reported Event|Dose 3: 10mg|Single dose of KAE609 10 mg
57414|NCT01836458|E2|Reported Event|Dose 2: 20mg|Single dose of KAE609 20 mg
57415|NCT01836458|E1|Reported Event|Dose 1: 30mg|Single dose of KAE609 30 mg
57416|NCT01836042|B4|Baseline|Total|Total of all reporting groups
57417|NCT01836042|B3|Baseline|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
57418|NCT01836042|B2|Baseline|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
57419|NCT01836042|B1|Baseline|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
57420|NCT01836042|P3|Participant Flow|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
57421|NCT01836042|P2|Participant Flow|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
57661|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57425|NCT01836042|O1|Outcome|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
57426|NCT01836042|E3|Reported Event|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
57427|NCT01836042|E2|Reported Event|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
57428|NCT01836042|E1|Reported Event|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
57429|NCT01835912|B1|Baseline|All Study Participants|"Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)~Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)"
57430|NCT01835912|P1|Participant Flow|All Study Participants|"Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.~4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo~Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Acute Placebo: 500 milliliters of flavoured water~Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water"
57431|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57432|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
57433|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57434|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
57435|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57436|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
57437|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57438|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
57439|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57440|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
57441|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57442|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
57443|NCT01835912|E4|Reported Event|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57444|NCT01835912|E3|Reported Event|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
57445|NCT01835912|E2|Reported Event|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
57446|NCT01835912|E1|Reported Event|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
57447|NCT01835899|B4|Baseline|Total|Total of all reporting groups
57448|NCT01835899|B3|Baseline|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57449|NCT01835899|B2|Baseline|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57450|NCT01835899|B1|Baseline|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
57451|NCT01835899|P3|Participant Flow|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57452|NCT01835899|P2|Participant Flow|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57453|NCT01835899|P1|Participant Flow|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
57454|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57455|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57456|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57457|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57458|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57459|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57460|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57461|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57462|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57463|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57464|NCT01835899|O3|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57465|NCT01835899|O2|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57466|NCT01835899|O1|Outcome|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
57467|NCT01835899|E3|Reported Event|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
57468|NCT01835899|E2|Reported Event|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
57469|NCT01835899|E1|Reported Event|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
57470|NCT01835756|B3|Baseline|Total|Total of all reporting groups
57471|NCT01835756|B2|Baseline|Placebo Laser|The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.
57472|NCT01835756|B1|Baseline|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57473|NCT01835756|P2|Participant Flow|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
57474|NCT01835756|P1|Participant Flow|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57475|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
57476|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57477|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
57478|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57479|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
57480|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57481|NCT01835756|E2|Reported Event|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
57482|NCT01835756|E1|Reported Event|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
57483|NCT01835743|B3|Baseline|Total|Total of all reporting groups
57484|NCT01835743|B2|Baseline|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57485|NCT01835743|B1|Baseline|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57486|NCT01835743|P2|Participant Flow|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57487|NCT01835743|P1|Participant Flow|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57488|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57489|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57490|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57491|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57492|NCT01835743|E2|Reported Event|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57493|NCT01835743|E1|Reported Event|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
57494|NCT01835496|B1|Baseline|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57495|NCT01835496|P1|Participant Flow|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57496|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57497|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57498|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57499|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57500|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57501|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57502|NCT01835496|E1|Reported Event|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
57503|NCT01835470|B1|Baseline|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57504|NCT01835470|P1|Participant Flow|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57505|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57506|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57507|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57508|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
57509|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57510|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57511|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
57512|NCT01835470|E1|Reported Event|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
57513|NCT01835431|B3|Baseline|Total|Total of all reporting groups
57514|NCT01835431|B2|Baseline|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57515|NCT01835431|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57516|NCT01835431|P2|Participant Flow|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57517|NCT01835431|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57518|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57519|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57520|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57521|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57522|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57523|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57524|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57525|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57526|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57527|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57528|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57529|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57530|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57531|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57532|NCT01835431|E2|Reported Event|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
57533|NCT01835431|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
57534|NCT01835379|B3|Baseline|Total|Total of all reporting groups
57535|NCT01835379|B2|Baseline|Standard|"Standard Care~Standard Care as chosen by the Investigator"
57536|NCT01835379|B1|Baseline|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
57537|NCT01835379|P2|Participant Flow|Standard|"Standard Care~Standard Care as chosen by the Investigator"
57538|NCT01835379|P1|Participant Flow|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
57539|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
57540|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
57541|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
57542|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
57543|NCT01835379|E2|Reported Event|Standard|"Standard Care~Standard Care as chosen by the Investigator"
57544|NCT01835379|E1|Reported Event|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
57545|NCT01835262|B3|Baseline|Total|Total of all reporting groups
57546|NCT01835262|B2|Baseline|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
57547|NCT01835262|B1|Baseline|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
57548|NCT01835262|P2|Participant Flow|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
57549|NCT01835262|P1|Participant Flow|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
57550|NCT01835262|O2|Outcome|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
57551|NCT01835262|O1|Outcome|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
57552|NCT01835262|E2|Reported Event|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
57553|NCT01835262|E1|Reported Event|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
57554|NCT01835132|B1|Baseline|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57555|NCT01835132|P1|Participant Flow|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57556|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57557|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57558|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57559|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57560|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57561|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57562|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57563|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57564|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57565|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57566|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57567|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57568|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57569|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57570|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57571|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57572|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57573|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57574|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57575|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57576|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57577|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57578|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57579|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57580|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57581|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57582|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57583|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57584|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57585|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57586|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57587|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57588|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57589|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57590|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57591|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57592|NCT01835132|E1|Reported Event|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
57593|NCT01835015|B6|Baseline|Total|Total of all reporting groups
57594|NCT01835015|B5|Baseline|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57595|NCT01835015|B4|Baseline|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57596|NCT01835015|B3|Baseline|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57597|NCT01835015|B2|Baseline|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57600|NCT01835015|P4|Participant Flow|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57601|NCT01835015|P3|Participant Flow|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57602|NCT01835015|P2|Participant Flow|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57603|NCT01835015|P1|Participant Flow|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57604|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57605|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57606|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57607|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57608|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57609|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57610|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57611|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57612|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57613|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57614|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57615|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57616|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57617|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57618|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57619|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57620|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57621|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57622|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57623|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57624|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57625|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57626|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57627|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57628|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57629|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57630|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57631|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57632|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57633|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57634|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57635|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57636|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57637|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57638|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57639|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57640|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57641|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57642|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57643|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57644|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57645|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57646|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57647|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57648|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57649|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57650|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57651|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57652|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57653|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57654|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57655|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57656|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57657|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57658|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57659|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57664|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
57665|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
57666|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
57667|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
57668|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
57669|NCT01835015|E6|Reported Event|Pretreatment|Reported prior to the initiation of study treatment
57670|NCT01835015|E5|Reported Event|CLG561, Level E|Reported subsequent to the initiation of treatment
57671|NCT01835015|E4|Reported Event|CLG561, Level D|Reported subsequent to the initiation of treatment
57672|NCT01835015|E3|Reported Event|CLG561, Level C|Reported subsequent to the initiation of treatment
57673|NCT01835015|E2|Reported Event|CLG561, Level B|Reported subsequent to the initiation of treatment
57674|NCT01835015|E1|Reported Event|CLG561, Level A|Reported subsequent to the initiation of treatment
57675|NCT01834404|B3|Baseline|Total|Total of all reporting groups
57676|NCT01834404|B2|Baseline|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57677|NCT01834404|B1|Baseline|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57678|NCT01834404|P2|Participant Flow|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57679|NCT01834404|P1|Participant Flow|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57680|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57681|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57682|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57683|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57684|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57685|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57686|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57687|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57688|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57689|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57690|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57691|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57692|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57693|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57694|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57695|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57696|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57697|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57996|NCT01831817|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
57698|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57699|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57700|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57701|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57702|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57703|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57704|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57705|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57706|NCT01834404|E2|Reported Event|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
57707|NCT01834404|E1|Reported Event|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
57708|NCT01834274|B3|Baseline|Total|Total of all reporting groups
57709|NCT01834274|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57710|NCT01834274|B1|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57711|NCT01834274|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57712|NCT01834274|P1|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57713|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57714|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57715|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57716|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57717|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57718|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57719|NCT01834274|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
57720|NCT01834274|E1|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
57721|NCT01834027|B3|Baseline|Total|Total of all reporting groups
57722|NCT01834027|B2|Baseline|No Music|"The patients in this group will have noise-cancelling headphones but no music will be played.~No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU"
57723|NCT01834027|B1|Baseline|Jazz Music|"Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
57724|NCT01834027|P2|Participant Flow|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
57725|NCT01834027|P1|Participant Flow|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
102119|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
57726|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
57727|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
57728|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
57729|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
57730|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
57731|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
57732|NCT01834027|E2|Reported Event|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
57733|NCT01834027|E1|Reported Event|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
57734|NCT01833897|B1|Baseline|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57735|NCT01833897|P1|Participant Flow|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57736|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57737|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57738|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57739|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57740|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57741|NCT01833897|E1|Reported Event|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
57742|NCT01833845|B1|Baseline|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
57743|NCT01833845|P1|Participant Flow|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
57777|NCT01833481|B3|Baseline|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
58261|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule.
57744|NCT01833845|O1|Outcome|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
57745|NCT01833845|E1|Reported Event|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
57746|NCT01833741|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57747|NCT01833741|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57748|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57749|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57750|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57751|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57752|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57753|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57754|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57755|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57756|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57757|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57758|NCT01833741|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
57759|NCT01833533|B3|Baseline|Total|Total of all reporting groups
57760|NCT01833533|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57761|NCT01833533|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57762|NCT01833533|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57763|NCT01833533|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57764|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57765|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57766|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57767|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57768|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57769|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57770|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57771|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57772|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57773|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57774|NCT01833533|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
57775|NCT01833533|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
57778|NCT01833481|B2|Baseline|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57779|NCT01833481|B1|Baseline|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57780|NCT01833481|P3|Participant Flow|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57781|NCT01833481|P2|Participant Flow|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57782|NCT01833481|P1|Participant Flow|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57783|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57784|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57785|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57786|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57787|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57788|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57789|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57790|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57791|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57792|NCT01833481|E3|Reported Event|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57793|NCT01833481|E2|Reported Event|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57794|NCT01833481|E1|Reported Event|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
57795|NCT01833403|B1|Baseline|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
57796|NCT01833403|P1|Participant Flow|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
57797|NCT01833403|O1|Outcome|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
57798|NCT01833403|E1|Reported Event|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
57799|NCT01833130|B3|Baseline|Total|Total of all reporting groups
57800|NCT01833130|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57801|NCT01833130|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57802|NCT01833130|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57803|NCT01833130|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57804|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57805|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57806|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57807|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57808|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57809|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57810|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57811|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57812|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57813|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57814|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57815|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57816|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57817|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57818|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57819|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57820|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57821|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57822|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57823|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57824|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57825|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
58262|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
57826|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57827|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57828|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57829|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57830|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57831|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57832|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57833|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57834|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57835|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57836|NCT01833130|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57837|NCT01833130|E1|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
57838|NCT01833117|B3|Baseline|Total|Total of all reporting groups
57839|NCT01833117|B2|Baseline|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
57840|NCT01833117|B1|Baseline|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
57841|NCT01833117|P2|Participant Flow|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
57842|NCT01833117|P1|Participant Flow|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
57843|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
57844|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
57845|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
57846|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
57847|NCT01833117|E2|Reported Event|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
57848|NCT01833117|E1|Reported Event|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
57849|NCT01833078|B1|Baseline|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
57850|NCT01833078|P1|Participant Flow|Ghrelin|All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
57851|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
57852|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
57853|NCT01833078|E1|Reported Event|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
57854|NCT01833065|B4|Baseline|Total|Total of all reporting groups
57855|NCT01833065|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form.
57856|NCT01833065|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form.
57857|NCT01833065|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form.
57858|NCT01833065|P5|Participant Flow|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
57859|NCT01833065|P4|Participant Flow|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
57860|NCT01833065|P3|Participant Flow|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
57861|NCT01833065|P2|Participant Flow|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
57862|NCT01833065|P1|Participant Flow|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
57863|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57864|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57865|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57866|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57867|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57868|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57869|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57870|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57871|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57872|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57873|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57874|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57875|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57876|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57877|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57878|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57879|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57880|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57881|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57882|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57883|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57884|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57885|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57886|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
57887|NCT01833065|E5|Reported Event|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
57888|NCT01833065|E4|Reported Event|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
57889|NCT01833065|E3|Reported Event|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
57890|NCT01833065|E2|Reported Event|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
57891|NCT01833065|E1|Reported Event|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
57892|NCT01832766|B1|Baseline|Entire Study Population|includes groups randomized to receive placebo first or dronabinol 10 mg first
57893|NCT01832766|P2|Participant Flow|Placebo First Then 10 mg Dronabinol|identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
57894|NCT01832766|P1|Participant Flow|Dronabinol 10 mg First Then Placebo|dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period
57895|NCT01832766|O2|Outcome|Placebo|identical capsule given once
57896|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
57897|NCT01832766|O2|Outcome|Placebo|identical capsule given once
57898|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
57899|NCT01832766|O2|Outcome|Placebo|identical capsule given once
57900|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
57901|NCT01832766|E2|Reported Event|Placebo|identical capsule given once
57902|NCT01832766|E1|Reported Event|Dronabinol|dronabinol 10 mg given oral one dose
57903|NCT01832506|B4|Baseline|Total|Total of all reporting groups
57904|NCT01832506|B3|Baseline|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57905|NCT01832506|B2|Baseline|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57906|NCT01832506|B1|Baseline|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57907|NCT01832506|P3|Participant Flow|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57908|NCT01832506|P2|Participant Flow|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57909|NCT01832506|P1|Participant Flow|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 milligram (mg) orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57910|NCT01832506|O1|Outcome|MSC2156119J Combined|All subjects who were administered with MSC2156119J 215 mg, 300mg or 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57911|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57912|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57913|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57914|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57915|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57916|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57917|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57918|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57919|NCT01832506|O1|Outcome|MSC2156119J 200 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57920|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57921|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57922|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57923|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57924|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57925|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57926|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57927|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57928|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57929|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57930|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57931|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57932|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57933|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57934|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57935|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57936|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57937|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57938|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57939|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57940|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57941|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57942|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57943|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57944|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57945|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57946|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57947|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57948|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57949|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57950|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57951|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57952|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57953|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57954|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57955|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57956|NCT01832506|E3|Reported Event|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57957|NCT01832506|E2|Reported Event|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57958|NCT01832506|E1|Reported Event|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
57959|NCT01832493|B1|Baseline|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
57960|NCT01832493|P1|Participant Flow|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
57961|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
57962|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
57963|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
57964|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
57965|NCT01832493|E1|Reported Event|All Enrolled Patients|Adverse events were collected and are reported for all 50 enrolled patients
57966|NCT01832155|B3|Baseline|Total|Total of all reporting groups
57967|NCT01832155|B2|Baseline|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57968|NCT01832155|B1|Baseline|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57969|NCT01832155|P2|Participant Flow|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57970|NCT01832155|P1|Participant Flow|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57971|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57972|NCT01832155|O2|Outcome|Yoga Intervention Group|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57973|NCT01832155|O1|Outcome|Wait-list Control Group|Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.
57974|NCT01832155|O1|Outcome|Both Groups During Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57975|NCT01832155|O1|Outcome|About the Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57976|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57977|NCT01832155|O1|Outcome|Class Rentention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57978|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57979|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57980|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57981|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57982|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57983|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57984|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57985|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57986|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57987|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57988|NCT01832155|E2|Reported Event|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
57989|NCT01832155|E1|Reported Event|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
57990|NCT01831817|B5|Baseline|Total|Total of all reporting groups
57991|NCT01831817|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
57992|NCT01831817|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
57993|NCT01831817|B2|Baseline|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
57994|NCT01831817|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
57995|NCT01831817|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
57997|NCT01831817|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
57998|NCT01831817|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
57999|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58000|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58001|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58002|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58003|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58004|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58005|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58006|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58007|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58008|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58009|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58010|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58011|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58012|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58013|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58014|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58015|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58016|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58017|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58018|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58019|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58020|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58021|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58022|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58023|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58024|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58025|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58026|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58027|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58028|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58029|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58030|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58031|NCT01831817|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
58032|NCT01831817|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
58033|NCT01831817|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58034|NCT01831817|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
58035|NCT01831791|B1|Baseline|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58036|NCT01831791|P1|Participant Flow|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58037|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58038|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58263|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58039|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58040|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58041|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58042|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58043|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58044|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58045|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58046|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58047|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58048|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58049|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58050|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58051|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58052|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58053|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58054|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58055|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58056|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58057|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58058|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58059|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58060|NCT01831791|E1|Reported Event|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
58061|NCT01831466|B13|Baseline|Total|Total of all reporting groups
58062|NCT01831466|B12|Baseline|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
58063|NCT01831466|B11|Baseline|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58064|NCT01831466|B10|Baseline|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58065|NCT01831466|B9|Baseline|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
58066|NCT01831466|B8|Baseline|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58067|NCT01831466|B7|Baseline|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58068|NCT01831466|B6|Baseline|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58069|NCT01831466|B5|Baseline|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58070|NCT01831466|B4|Baseline|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58071|NCT01831466|B3|Baseline|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58072|NCT01831466|B2|Baseline|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58073|NCT01831466|B1|Baseline|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58074|NCT01831466|P12|Participant Flow|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
58075|NCT01831466|P11|Participant Flow|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58076|NCT01831466|P10|Participant Flow|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58077|NCT01831466|P9|Participant Flow|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
58078|NCT01831466|P8|Participant Flow|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58079|NCT01831466|P7|Participant Flow|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58080|NCT01831466|P6|Participant Flow|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58081|NCT01831466|P5|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58082|NCT01831466|P4|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58083|NCT01831466|P3|Participant Flow|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58084|NCT01831466|P2|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58085|NCT01831466|P1|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)|Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58086|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58087|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58088|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58089|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58090|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58091|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58092|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58093|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58094|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58095|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58096|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58097|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58098|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58099|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58100|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58101|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58102|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58103|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58104|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58105|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58106|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58107|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58108|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58109|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58110|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58111|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58112|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58113|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58114|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58115|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58116|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
102120|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
58117|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58118|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58119|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58120|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58121|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58122|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58123|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58124|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58125|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58126|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58127|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58128|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58129|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58130|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58131|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58132|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58133|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58134|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58135|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58136|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58137|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58138|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58139|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58140|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58141|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58142|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58143|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58144|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58145|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58146|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58147|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58148|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58149|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58150|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58151|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58152|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58153|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58154|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58155|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58156|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58157|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58158|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58159|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58160|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58161|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58162|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58163|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58164|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58165|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58166|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58167|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58168|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58169|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58170|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58171|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58172|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58173|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58174|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58175|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58176|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58177|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58178|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58179|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58180|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58181|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58182|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58183|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58184|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58185|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58186|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58187|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58188|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58189|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58190|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58191|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58192|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58193|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58194|NCT01831466|E12|Reported Event|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
58195|NCT01831466|E11|Reported Event|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58196|NCT01831466|E10|Reported Event|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58197|NCT01831466|E9|Reported Event|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
58198|NCT01831466|E8|Reported Event|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58199|NCT01831466|E7|Reported Event|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58200|NCT01831466|E6|Reported Event|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
58201|NCT01831466|E5|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
58202|NCT01831466|E4|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
58203|NCT01831466|E3|Reported Event|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
58204|NCT01831466|E2|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
58205|NCT01831466|E1|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
58206|NCT01831219|B3|Baseline|Total|Total of all reporting groups
58207|NCT01831219|B2|Baseline|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58208|NCT01831219|B1|Baseline|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58209|NCT01831219|P2|Participant Flow|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58210|NCT01831219|P1|Participant Flow|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58211|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58212|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58213|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58214|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58215|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58216|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58217|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58218|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58219|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58220|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58221|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58222|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58223|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58224|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
58225|NCT01831219|E2|Reported Event|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
58226|NCT01831219|E1|Reported Event|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical sys...
58227|NCT01830933|B3|Baseline|Total|Total of all reporting groups
102121|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
58228|NCT01830933|B2|Baseline|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58229|NCT01830933|B1|Baseline|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58230|NCT01830933|P2|Participant Flow|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58231|NCT01830933|P1|Participant Flow|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58232|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58233|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58234|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58235|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58236|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58237|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58238|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58239|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58240|NCT01830933|E2|Reported Event|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
58241|NCT01830933|E1|Reported Event|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
58242|NCT01830855|B5|Baseline|Total|Total of all reporting groups
58243|NCT01830855|B4|Baseline|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58244|NCT01830855|B3|Baseline|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58245|NCT01830855|B2|Baseline|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58246|NCT01830855|B1|Baseline|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58247|NCT01830855|P4|Participant Flow|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58248|NCT01830855|P3|Participant Flow|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58249|NCT01830855|P2|Participant Flow|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58250|NCT01830855|P1|Participant Flow|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58251|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58252|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58253|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58254|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58255|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58256|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58257|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58258|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58259|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58260|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule.
58270|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58271|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58272|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58273|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58274|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58275|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58276|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58277|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58278|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58279|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58280|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58281|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58282|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58283|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58284|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58285|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58286|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58287|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58288|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58289|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58290|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58291|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58292|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58293|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58294|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58295|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58296|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58297|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58298|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58299|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58300|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58301|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58302|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58303|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58304|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58305|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58306|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58307|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58308|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58309|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58310|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58311|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58312|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58313|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58314|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58315|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58316|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58317|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58318|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58319|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58320|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58321|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58322|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58323|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58324|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58325|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58326|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58327|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58328|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58329|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58330|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58331|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58332|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58333|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58334|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58335|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58336|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58337|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58338|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58339|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58340|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58341|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58342|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58343|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58344|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
58345|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58346|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58347|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58348|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58349|NCT01830855|E4|Reported Event|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
58350|NCT01830855|E3|Reported Event|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
58351|NCT01830855|E2|Reported Event|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
58352|NCT01830855|E1|Reported Event|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
58353|NCT01830790|B3|Baseline|Total|Total of all reporting groups
58354|NCT01830790|B2|Baseline|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58355|NCT01830790|B1|Baseline|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58356|NCT01830790|P2|Participant Flow|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58357|NCT01830790|P1|Participant Flow|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58358|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58359|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58360|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58361|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58362|NCT01830790|E2|Reported Event|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58363|NCT01830790|E1|Reported Event|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
58364|NCT01830699|B3|Baseline|Total|Total of all reporting groups
58365|NCT01830699|B2|Baseline|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
102122|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg|9/9.6 μg
58366|NCT01830699|B1|Baseline|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58367|NCT01830699|P2|Participant Flow|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
58368|NCT01830699|P1|Participant Flow|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58369|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
58370|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58371|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
58372|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58373|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
58374|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58375|NCT01830699|E2|Reported Event|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
58376|NCT01830699|E1|Reported Event|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
58377|NCT01830205|B5|Baseline|Total|Total of all reporting groups
58378|NCT01830205|B4|Baseline|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58379|NCT01830205|B3|Baseline|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58380|NCT01830205|B2|Baseline|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58381|NCT01830205|B1|Baseline|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58382|NCT01830205|P4|Participant Flow|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58383|NCT01830205|P3|Participant Flow|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58384|NCT01830205|P2|Participant Flow|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58385|NCT01830205|P1|Participant Flow|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58386|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58423|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58387|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58388|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58389|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58390|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58391|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58392|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58393|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58394|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58395|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58396|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58397|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58398|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58399|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58424|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58581|NCT01829191|P2|Participant Flow|Test Lens C|Test lens will be worn in a daily wear modality
58400|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58401|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58402|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58403|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58404|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
58405|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58406|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58407|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58408|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58409|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58410|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58411|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58412|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58413|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58414|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58415|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58416|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58417|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58418|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58419|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58420|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58421|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58422|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58425|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58426|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58427|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58428|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58429|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58430|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58431|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58432|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58433|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58434|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58435|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58436|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58437|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58438|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58439|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58440|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58441|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58442|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58443|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
58444|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58445|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58446|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58447|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58448|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58449|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
58576|NCT01829230|E2|Reported Event|Test Lens A|Test lens A from previous study
58450|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58451|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
58452|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58453|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
58454|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58455|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58456|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58457|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) < 15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58458|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58459|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58460|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58461|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58462|NCT01830205|E4|Reported Event|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
58463|NCT01830205|E3|Reported Event|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58464|NCT01830205|E2|Reported Event|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58465|NCT01830205|E1|Reported Event|Group-A|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
58466|NCT01830140|B3|Baseline|Total|Total of all reporting groups
58467|NCT01830140|B2|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
58468|NCT01830140|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
58469|NCT01830140|P2|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
58470|NCT01830140|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
58471|NCT01830140|O2|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
58472|NCT01830140|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
58473|NCT01830140|E2|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
58474|NCT01830140|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
58475|NCT01830127|B3|Baseline|Total|Total of all reporting groups
58476|NCT01830127|B2|Baseline|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58577|NCT01829230|E1|Reported Event|Test Lens C|Test lens C from previous study
58477|NCT01830127|B1|Baseline|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58478|NCT01830127|P2|Participant Flow|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58479|NCT01830127|P1|Participant Flow|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58480|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58481|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58482|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58483|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58484|NCT01830127|E2|Reported Event|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58485|NCT01830127|E1|Reported Event|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
58486|NCT01829919|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58487|NCT01829919|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58488|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58489|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58490|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58491|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58492|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58493|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58494|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58495|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58496|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58497|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58498|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58499|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58500|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58501|NCT01829919|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
58502|NCT01829516|B1|Baseline|All Study Participants|This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
58578|NCT01829191|B3|Baseline|Total|Total of all reporting groups
58579|NCT01829191|B2|Baseline|Test Lens C|Test lens will be worn in a daily wear modality
58503|NCT01829516|P2|Participant Flow|Placebo First Then Oxytocin|"14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.~NOTE: This is a cross-over design and subjects will participate in both arms."
58504|NCT01829516|P1|Participant Flow|Oxytocin First, Then Placebo|"18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms."
58505|NCT01829516|O2|Outcome|Placebo|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
58506|NCT01829516|O1|Outcome|Oxytocin|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
58507|NCT01829516|O2|Outcome|Placebo|14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
58508|NCT01829516|O1|Outcome|Oxytocin|18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
58509|NCT01829516|E2|Reported Event|Placebo|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms.~Placebo"
58510|NCT01829516|E1|Reported Event|Oxytocin|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.~Oxytocin"
58511|NCT01829477|B3|Baseline|Total|Total of all reporting groups
58512|NCT01829477|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58513|NCT01829477|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58514|NCT01829477|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58515|NCT01829477|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58516|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58517|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58518|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58519|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58520|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58521|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58522|NCT01829477|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58523|NCT01829477|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
58524|NCT01829464|B4|Baseline|Total|Total of all reporting groups
58525|NCT01829464|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58526|NCT01829464|B2|Baseline|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58527|NCT01829464|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58528|NCT01829464|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58529|NCT01829464|P2|Participant Flow|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58530|NCT01829464|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58531|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58532|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58533|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58580|NCT01829191|B1|Baseline|Test Lens A|Test lenses will be worn in a daily wear modality
58534|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58535|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58536|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58537|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58538|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58539|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58540|NCT01829464|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58541|NCT01829464|E2|Reported Event|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
58542|NCT01829464|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
58543|NCT01829399|B3|Baseline|Total|Total of all reporting groups
58544|NCT01829399|B2|Baseline|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
58545|NCT01829399|B1|Baseline|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
58546|NCT01829399|P2|Participant Flow|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
58547|NCT01829399|P1|Participant Flow|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
58548|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation.
58549|NCT01829399|O1|Outcome|Bupivacaine Ring 1st Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
58550|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline.
58551|NCT01829399|O1|Outcome|Bupivacaine Axillary Ring on 1st Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
58552|NCT01829399|E2|Reported Event|Saline Axillary Ring (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline
58553|NCT01829399|E1|Reported Event|Bupivacaine Axillary Ring|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000
58554|NCT01829243|B1|Baseline|Subjects Who Completed the Study|
58555|NCT01829243|P2|Participant Flow|Placebo First, Then Milnacipran|Patients randomized to receive placebo first
58556|NCT01829243|P1|Participant Flow|Milnacipran First, Then Placebo|Patients randomized to receiving milnacipran first.
58557|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
58558|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking the Milnacipran.
58559|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
58560|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran
58561|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
58562|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
58563|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
58564|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
58565|NCT01829243|E2|Reported Event|Placebo|Adverse events in this group occurred while subjects were taking Placebo.
58566|NCT01829243|E1|Reported Event|Milnacipran|Adverse events in this group occurred while subjects were taking Milnacipran.
58567|NCT01829230|B3|Baseline|Total|Total of all reporting groups
58568|NCT01829230|B2|Baseline|Test Lens A|Test lens A from previous study
58569|NCT01829230|B1|Baseline|Test Lens C|Test lens C from previous study
58570|NCT01829230|P2|Participant Flow|Test Lens A|Test lens A from previous study
58571|NCT01829230|P1|Participant Flow|Test Lens C|Test lens C from previous study
58572|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
58573|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
58574|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
58575|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
58582|NCT01829191|P1|Participant Flow|Test Lens A|Test lenses will be worn in a daily wear modality
58583|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
58584|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
58585|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
58586|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
58587|NCT01829191|E1|Reported Event|All Subjects|All subjects who eligible to participate in the study whether or not randomized to the study arm.
58588|NCT01828593|B4|Baseline|Total|Total of all reporting groups
58589|NCT01828593|B3|Baseline|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58590|NCT01828593|B2|Baseline|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58591|NCT01828593|B1|Baseline|Placebo|Matching Placebo
58592|NCT01828593|P3|Participant Flow|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58593|NCT01828593|P2|Participant Flow|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58594|NCT01828593|P1|Participant Flow|Placebo|"Matching Placebo~Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g"
58595|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58596|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58597|NCT01828593|O1|Outcome|Placebo|Matching Placebo
58598|NCT01828593|O3|Outcome|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58599|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58600|NCT01828593|O1|Outcome|Placebo|Matching Placebo
58601|NCT01828593|E2|Reported Event|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58602|NCT01828593|E1|Reported Event|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
58603|NCT01828281|B3|Baseline|Total|Total of all reporting groups
58604|NCT01828281|B2|Baseline|Control|subtherapeutic CPAP using 4 cm water
58647|NCT01827592|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58605|NCT01828281|B1|Baseline|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58606|NCT01828281|P2|Participant Flow|Control|subtherapeutic CPAP using 4 cm water
58607|NCT01828281|P1|Participant Flow|Therapeutic CPAP|The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58608|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
58609|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58610|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
58611|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58612|NCT01828281|O2|Outcome|Control|"subtherapeutic CPAP using 4 cm water~CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water."
58613|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58614|NCT01828281|E2|Reported Event|Control|subtherapeutic CPAP using 4 cm water
58615|NCT01828281|E1|Reported Event|Therapeutic CPAP|The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
58616|NCT01828216|B3|Baseline|Total|Total of all reporting groups
58617|NCT01828216|B2|Baseline|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
58618|NCT01828216|B1|Baseline|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
58619|NCT01828216|P2|Participant Flow|Ambulatory Sleep Study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
58620|NCT01828216|P1|Participant Flow|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
58621|NCT01828216|O2|Outcome|Ambulatory Sleep Study|Home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
58622|NCT01828216|O1|Outcome|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
58623|NCT01828216|O2|Outcome|Ambulatory CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
58624|NCT01828216|O1|Outcome|In-hospital CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
58625|NCT01828216|E2|Reported Event|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
58626|NCT01828216|E1|Reported Event|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
58627|NCT01827670|B3|Baseline|Total|Total of all reporting groups
58628|NCT01827670|B2|Baseline|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
102123|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
58629|NCT01827670|B1|Baseline|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58630|NCT01827670|P2|Participant Flow|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
58631|NCT01827670|P1|Participant Flow|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
58632|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
58633|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58634|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
58635|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58636|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride Dentifrice)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
58637|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 mililiter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
58638|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
58639|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58640|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
58641|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58642|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
58643|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
58644|NCT01827670|E2|Reported Event|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
58645|NCT01827670|E1|Reported Event|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
58646|NCT01827592|B4|Baseline|Total|Total of all reporting groups
58648|NCT01827592|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58649|NCT01827592|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58650|NCT01827592|P3|Participant Flow|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58651|NCT01827592|P2|Participant Flow|EBX 5|Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
58652|NCT01827592|P1|Participant Flow|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
58653|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58654|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58655|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58656|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58657|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58658|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58659|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58660|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58661|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58662|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58663|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58664|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58665|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58666|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58667|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58668|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58669|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58670|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58671|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58672|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58673|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58674|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58675|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58676|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58677|NCT01827592|E3|Reported Event|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
58678|NCT01827592|E2|Reported Event|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58679|NCT01827592|E1|Reported Event|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
58680|NCT01827475|B4|Baseline|Total|Total of all reporting groups
58681|NCT01827475|B3|Baseline|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
58682|NCT01827475|B2|Baseline|Acetaminophen|Acetaminophen 1 gm
58683|NCT01827475|B1|Baseline|Ibuprofen|Ibuprofen 800 mg
58684|NCT01827475|P3|Participant Flow|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
58685|NCT01827475|P2|Participant Flow|Acetaminophen|Acetaminophen 1 gm
58686|NCT01827475|P1|Participant Flow|Ibuprofen|Ibuprofen 800 mg
58687|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
58688|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
58689|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
58690|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
58691|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
58692|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
58693|NCT01827475|E3|Reported Event|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
58694|NCT01827475|E2|Reported Event|Acetaminophen|Acetaminophen 1 gm
58695|NCT01827475|E1|Reported Event|Ibuprofen|Ibuprofen 800 mg
58696|NCT01827371|B5|Baseline|Total|Total of all reporting groups
58697|NCT01827371|B4|Baseline|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58698|NCT01827371|B3|Baseline|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58699|NCT01827371|B2|Baseline|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58700|NCT01827371|B1|Baseline|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
59544|NCT01821534|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was administered.
58701|NCT01827371|P4|Participant Flow|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58702|NCT01827371|P3|Participant Flow|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58703|NCT01827371|P2|Participant Flow|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58704|NCT01827371|P1|Participant Flow|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58705|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58706|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58707|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58708|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58709|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58710|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58711|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58712|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58713|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58714|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58715|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58716|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58717|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58718|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58719|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58720|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58721|NCT01827371|E4|Reported Event|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
58722|NCT01827371|E3|Reported Event|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
58723|NCT01827371|E2|Reported Event|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
58724|NCT01827371|E1|Reported Event|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
58725|NCT01827332|B3|Baseline|Total|Total of all reporting groups
58726|NCT01827332|B2|Baseline|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
58727|NCT01827332|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
58728|NCT01827332|P2|Participant Flow|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
58729|NCT01827332|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
58730|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
58731|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
58732|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
58733|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
58734|NCT01827332|E2|Reported Event|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
58735|NCT01827332|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
58736|NCT01827319|B1|Baseline|Received TMR and Enrolled in ANGINA RELIEF Registry|
58737|NCT01827319|P1|Participant Flow|Received TMR and Enrolled in ANGINA RELIEF Registry|
58738|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
58739|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
58740|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
58741|NCT01827319|E1|Reported Event|Received TMR and Enrolled in ANGINA RELIEF Registry|
58742|NCT01827306|B3|Baseline|Total|Total of all reporting groups
58743|NCT01827306|B2|Baseline|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58744|NCT01827306|B1|Baseline|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58745|NCT01827306|P2|Participant Flow|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58746|NCT01827306|P1|Participant Flow|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58747|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58748|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58749|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58750|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58751|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58752|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58753|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58754|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58755|NCT01827306|E2|Reported Event|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
58756|NCT01827306|E1|Reported Event|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
58757|NCT01827254|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
58758|NCT01827254|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
58759|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by third line treatment with bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
58760|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by second line treatment with bevacizumab (with interferon),bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
58761|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­interventional study.
58762|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
58763|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
58764|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-­interventional study.
58765|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
58766|NCT01827254|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
58767|NCT01826981|B16|Baseline|Total|Total of all reporting groups
58768|NCT01826981|B15|Baseline|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58769|NCT01826981|B14|Baseline|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58935|NCT01826981|E7|Reported Event|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58770|NCT01826981|B13|Baseline|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58771|NCT01826981|B12|Baseline|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58772|NCT01826981|B11|Baseline|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58773|NCT01826981|B10|Baseline|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58774|NCT01826981|B9|Baseline|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58775|NCT01826981|B8|Baseline|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58776|NCT01826981|B7|Baseline|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58777|NCT01826981|B6|Baseline|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58778|NCT01826981|B5|Baseline|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58779|NCT01826981|B4|Baseline|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58780|NCT01826981|B3|Baseline|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58781|NCT01826981|B2|Baseline|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58782|NCT01826981|B1|Baseline|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58783|NCT01826981|P15|Participant Flow|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58784|NCT01826981|P14|Participant Flow|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58785|NCT01826981|P13|Participant Flow|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58786|NCT01826981|P12|Participant Flow|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58787|NCT01826981|P11|Participant Flow|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58788|NCT01826981|P10|Participant Flow|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58789|NCT01826981|P9|Participant Flow|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
58790|NCT01826981|P8|Participant Flow|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58791|NCT01826981|P7|Participant Flow|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58792|NCT01826981|P6|Participant Flow|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58793|NCT01826981|P5|Participant Flow|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58794|NCT01826981|P4|Participant Flow|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58795|NCT01826981|P3|Participant Flow|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58796|NCT01826981|P2|Participant Flow|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
59059|NCT01824823|E2|Reported Event|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
58797|NCT01826981|P1|Participant Flow|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58798|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58799|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58800|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58801|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58802|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58803|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58804|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58805|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58806|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58807|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58808|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58809|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58810|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58811|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58812|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58813|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58814|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58815|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58816|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58817|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58818|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58819|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58820|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58821|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58822|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58823|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58824|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
59060|NCT01824823|E1|Reported Event|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
58825|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58826|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58827|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58828|NCT01826981|O1|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58829|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58830|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58831|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58832|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58833|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58834|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58835|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58836|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58837|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58838|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58839|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58840|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58841|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58842|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58843|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58844|NCT01826981|O1|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58845|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58846|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58847|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58848|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58849|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58850|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58851|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58906|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58852|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58853|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58854|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58855|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58856|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58857|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58858|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58859|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58860|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58861|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58862|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58863|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58864|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58865|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58866|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58867|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58868|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58869|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58870|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58871|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58872|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58873|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58874|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58875|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58876|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58877|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58878|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58907|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58879|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58880|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58881|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58882|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58883|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58884|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58885|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58886|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58887|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58888|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58889|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58890|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58891|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58892|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58893|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58894|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58895|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58896|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58897|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58898|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58899|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58900|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58901|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58902|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58903|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58904|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58905|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
59061|NCT01823653|B1|Baseline|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
58908|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58909|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58910|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58911|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58912|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58913|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58914|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58915|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58916|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58917|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58918|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58919|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58920|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
58921|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58922|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58923|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58924|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58925|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58926|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58927|NCT01826981|E15|Reported Event|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58928|NCT01826981|E14|Reported Event|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58929|NCT01826981|E13|Reported Event|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58930|NCT01826981|E12|Reported Event|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
58931|NCT01826981|E11|Reported Event|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
58932|NCT01826981|E10|Reported Event|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58933|NCT01826981|E9|Reported Event|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
58934|NCT01826981|E8|Reported Event|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
58936|NCT01826981|E6|Reported Event|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
58937|NCT01826981|E5|Reported Event|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
58938|NCT01826981|E4|Reported Event|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58939|NCT01826981|E3|Reported Event|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
58940|NCT01826981|E2|Reported Event|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
58941|NCT01826981|E1|Reported Event|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
58942|NCT01826812|B3|Baseline|Total|Total of all reporting groups
58943|NCT01826812|B2|Baseline|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58944|NCT01826812|B1|Baseline|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58945|NCT01826812|P2|Participant Flow|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58946|NCT01826812|P1|Participant Flow|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58947|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58948|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58949|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58950|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58951|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58952|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58953|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58954|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58955|NCT01826812|E2|Reported Event|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
58956|NCT01826812|E1|Reported Event|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
58957|NCT01826604|B3|Baseline|Total|Total of all reporting groups
58958|NCT01826604|B2|Baseline|Control|Other retractor used during C-section
58959|NCT01826604|B1|Baseline|Alexis O C-section Retractor|Alexis O retractor used during C-section
58960|NCT01826604|P2|Participant Flow|Control|"Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.~Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used."
58961|NCT01826604|P1|Participant Flow|Alexis O C-section Retractor|"The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.~Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used."
58962|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
58963|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
58964|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
58965|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
58966|NCT01826604|E2|Reported Event|Control|No adverse events
58967|NCT01826604|E1|Reported Event|Alexis Retractor|No adverse events
58968|NCT01826370|B1|Baseline|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58969|NCT01826370|P1|Participant Flow|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58970|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58971|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58972|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58973|NCT01826370|E1|Reported Event|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
58974|NCT01826214|B3|Baseline|Total|Total of all reporting groups
59685|NCT01820559|P2|Participant Flow|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
58975|NCT01826214|B2|Baseline|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58976|NCT01826214|B1|Baseline|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58977|NCT01826214|P2|Participant Flow|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58978|NCT01826214|P1|Participant Flow|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58979|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58980|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58981|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58982|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58983|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58984|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58985|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58986|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58987|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58988|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58989|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58990|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58991|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58992|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58993|NCT01826214|E2|Reported Event|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58994|NCT01826214|E1|Reported Event|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
58995|NCT01826201|B1|Baseline|10% MOL4239 Ointment & Placebo Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
58996|NCT01826201|P1|Participant Flow|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
58997|NCT01826201|O1|Outcome|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
58998|NCT01826201|O2|Outcome|Placebo Ointment|10% MOL4239 to one target lesion and placebo to contralateral target lesion
58999|NCT01826201|O1|Outcome|10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
59000|NCT01826201|E1|Reported Event|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
59001|NCT01825837|B5|Baseline|Total|Total of all reporting groups
59062|NCT01823653|P1|Participant Flow|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
59002|NCT01825837|B4|Baseline|ESL (Part I - Not Randomised Patients)|This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group.
59003|NCT01825837|B3|Baseline|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59004|NCT01825837|B2|Baseline|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59005|NCT01825837|B1|Baseline|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59006|NCT01825837|P4|Participant Flow|ESL (Part I)|In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II.
59007|NCT01825837|P3|Participant Flow|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59008|NCT01825837|P2|Participant Flow|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59009|NCT01825837|P1|Participant Flow|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59010|NCT01825837|O3|Outcome|BIA 2-093 1800 mg|PART II - Intent-to-Treat Population
59011|NCT01825837|O2|Outcome|BIA 2-093 900 mg|PART II - Intent-to-Treat Population
59012|NCT01825837|O1|Outcome|BIA 2-093 300 mg|PART II - Intent-to-Treat Population
59013|NCT01825837|E3|Reported Event|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59014|NCT01825837|E2|Reported Event|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59015|NCT01825837|E1|Reported Event|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
59016|NCT01825577|B1|Baseline|Single Arm|"Age 65yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
59017|NCT01825577|P1|Participant Flow|Single Arm Transdermal Methylphenidate|"Age 65 yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
59018|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
59019|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
59020|NCT01825577|E1|Reported Event|Single Arm Transdermal Methylphenidate|There were no adverse events reported.
59021|NCT01825200|B3|Baseline|Total|Total of all reporting groups
59022|NCT01825200|B2|Baseline|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59023|NCT01825200|B1|Baseline|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59024|NCT01825200|P2|Participant Flow|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59025|NCT01825200|P1|Participant Flow|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59026|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59027|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59028|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59029|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59030|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59031|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59032|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59033|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59034|NCT01825200|E2|Reported Event|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
59035|NCT01825200|E1|Reported Event|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
59036|NCT01825122|B3|Baseline|Total|Total of all reporting groups
59037|NCT01825122|B2|Baseline|Active, Nadolol|"Active~Nadolol"
59038|NCT01825122|B1|Baseline|Placebo|"placebo~Placebo"
59039|NCT01825122|P2|Participant Flow|Active, Nadolol|"Active~Nadolol"
59040|NCT01825122|P1|Participant Flow|Placebo|"placebo~Placebo"
59041|NCT01825122|O2|Outcome|Active, Nadolol|"Active~Nadolol"
59042|NCT01825122|O1|Outcome|Placebo|"placebo~Placebo"
59043|NCT01825122|E2|Reported Event|Active, Nadolol|"Active~Nadolol"
59044|NCT01825122|E1|Reported Event|Placebo|"placebo~Placebo"
59045|NCT01824901|B1|Baseline|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
59046|NCT01824901|P4|Participant Flow|Phase II Step II|"Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~AZD4547: Given PO"
59047|NCT01824901|P3|Participant Flow|Arm II (Docetaxel and AZD4547; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
59048|NCT01824901|P2|Participant Flow|Arm I (Docetaxel; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14.~docetaxel: Given IV"
59049|NCT01824901|P1|Participant Flow|Phase I|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
59050|NCT01824901|O1|Outcome|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
59051|NCT01824901|E1|Reported Event|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
59052|NCT01824823|B3|Baseline|Total|Total of all reporting groups
59053|NCT01824823|B2|Baseline|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
59054|NCT01824823|B1|Baseline|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
59055|NCT01824823|P2|Participant Flow|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
59056|NCT01824823|P1|Participant Flow|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
59057|NCT01824823|O2|Outcome|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
59058|NCT01824823|O1|Outcome|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
59063|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
59064|NCT01823653|O1|Outcome|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
59065|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
59066|NCT01823653|O2|Outcome|Control Thigh|Each subject's own thigh untreated during study
59067|NCT01823653|O1|Outcome|Treated Thigh|Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)
59068|NCT01823653|E1|Reported Event|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
59069|NCT01823614|B7|Baseline|Total|Total of all reporting groups
59070|NCT01823614|B6|Baseline|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
59071|NCT01823614|B5|Baseline|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
59072|NCT01823614|B4|Baseline|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
59073|NCT01823614|B3|Baseline|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
59074|NCT01823614|B2|Baseline|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
59075|NCT01823614|B1|Baseline|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
59076|NCT01823614|P6|Participant Flow|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
59077|NCT01823614|P5|Participant Flow|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
59078|NCT01823614|P4|Participant Flow|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
59079|NCT01823614|P3|Participant Flow|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
59080|NCT01823614|P2|Participant Flow|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
59081|NCT01823614|P1|Participant Flow|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
59082|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
59083|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
59084|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
59085|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
59086|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
59087|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
59088|NCT01823614|O6|Outcome|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
59089|NCT01823614|O5|Outcome|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
59090|NCT01823614|O4|Outcome|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
59091|NCT01823614|O3|Outcome|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
59092|NCT01823614|O2|Outcome|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
59093|NCT01823614|O1|Outcome|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
59094|NCT01823614|E6|Reported Event|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
59095|NCT01823614|E5|Reported Event|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
59096|NCT01823614|E4|Reported Event|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
59097|NCT01823614|E3|Reported Event|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
59098|NCT01823614|E2|Reported Event|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
59099|NCT01823614|E1|Reported Event|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
59100|NCT01824602|B5|Baseline|Total|Total of all reporting groups
59101|NCT01824602|B4|Baseline|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59102|NCT01824602|B3|Baseline|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59103|NCT01824602|B2|Baseline|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59104|NCT01824602|B1|Baseline|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
59105|NCT01824602|P4|Participant Flow|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59106|NCT01824602|P3|Participant Flow|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59107|NCT01824602|P2|Participant Flow|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
59108|NCT01824602|P1|Participant Flow|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
59109|NCT01824602|O4|Outcome|ESL 1800 mg|(ITT Population
59110|NCT01824602|O3|Outcome|ESL 1200 mg|ITT Population
59111|NCT01824602|O2|Outcome|ESL 600 mg|ITT Population
59112|NCT01824602|O1|Outcome|Placebo|ITT Population
59113|NCT01824602|E4|Reported Event|ESL 1800 mg|Safety Population
59114|NCT01824602|E3|Reported Event|ESL 1200 mg|Safety Population
59115|NCT01824602|E2|Reported Event|ESL 600 mg|Safety Population
59116|NCT01824602|E1|Reported Event|Placebo|Safety Population
59117|NCT01824589|B5|Baseline|Total|Total of all reporting groups
59118|NCT01824589|B4|Baseline|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59119|NCT01824589|B3|Baseline|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59120|NCT01824589|B2|Baseline|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59121|NCT01824589|B1|Baseline|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59122|NCT01824589|P4|Participant Flow|Group D|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59123|NCT01824589|P3|Participant Flow|Group C|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59124|NCT01824589|P2|Participant Flow|Group B|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59125|NCT01824589|P1|Participant Flow|Group A|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59126|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59127|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59128|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59147|NCT01824498|B6|Baseline|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59686|NCT01820559|P1|Participant Flow|Placebo|"Placebo tablets~Placebo : Tablets"
59129|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59130|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59131|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59132|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59133|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59134|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59135|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59136|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59137|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59138|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59139|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59140|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59141|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59142|NCT01824589|E4|Reported Event|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59143|NCT01824589|E3|Reported Event|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
59144|NCT01824589|E2|Reported Event|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59145|NCT01824589|E1|Reported Event|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
59146|NCT01824498|B7|Baseline|Total|Total of all reporting groups
59687|NCT01820559|O3|Outcome|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
59148|NCT01824498|B5|Baseline|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59149|NCT01824498|B4|Baseline|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59150|NCT01824498|B3|Baseline|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59151|NCT01824498|B2|Baseline|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59152|NCT01824498|B1|Baseline|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59153|NCT01824498|P6|Participant Flow|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59154|NCT01824498|P5|Participant Flow|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59155|NCT01824498|P4|Participant Flow|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59156|NCT01824498|P3|Participant Flow|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59157|NCT01824498|P2|Participant Flow|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59158|NCT01824498|P1|Participant Flow|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
59159|NCT01824498|O3|Outcome|Low Fat, High n3 Diet|Low fat, n3 diet = 20% fat + 3% n3
59160|NCT01824498|O2|Outcome|Low Fat Diet|Low fat diet = 20% fat
59161|NCT01824498|O1|Outcome|High Fat Diet|Hig fat diet = 40% fat
59162|NCT01824498|E3|Reported Event|Low Fat, High n3 Diet|Low fat, high n3 diet = 20% fat + 3% n3
59163|NCT01824498|E2|Reported Event|Low Fat Diet|Low fat diet = 20% fat
59164|NCT01824498|E1|Reported Event|High Fat Diet|High fat diet = 40% fat
59165|NCT01824446|B1|Baseline|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59166|NCT01824446|P1|Participant Flow|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59167|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59168|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59169|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59170|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59171|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59172|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59173|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59174|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59175|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59176|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59177|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59178|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59179|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59180|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59181|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59182|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59183|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59184|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59185|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59186|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
59187|NCT01824446|E1|Reported Event|[14C]SSP-004184|
59188|NCT01824355|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59189|NCT01824355|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59190|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59217|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59218|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59191|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59192|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59193|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59194|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59195|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59196|NCT01824355|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
59197|NCT01824342|B3|Baseline|Total|Total of all reporting groups
59198|NCT01824342|B2|Baseline|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59199|NCT01824342|B1|Baseline|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59200|NCT01824342|P2|Participant Flow|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59201|NCT01824342|P1|Participant Flow|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59202|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59203|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59204|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59205|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59206|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59207|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59208|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59209|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59210|NCT01824342|E2|Reported Event|Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59211|NCT01824342|E1|Reported Event|Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
59212|NCT01824303|B3|Baseline|Total|Total of all reporting groups
59213|NCT01824303|B2|Baseline|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59214|NCT01824303|B1|Baseline|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59215|NCT01824303|P2|Participant Flow|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59216|NCT01824303|P1|Participant Flow|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59420|NCT01822665|E1|Reported Event|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
59219|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59220|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59221|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59222|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59223|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59224|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59225|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59226|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59227|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59228|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59229|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59230|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59231|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59232|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59233|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
59234|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
59235|NCT01824303|E4|Reported Event|LiRIS Placebo/LiRIS 400 mg _Open Label Extension|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
59236|NCT01824303|E3|Reported Event|LiRIS 400 mg_Open Label Extension|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
59237|NCT01824303|E2|Reported Event|LiRIS Placebo_Randomized Study|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study.
59238|NCT01824303|E1|Reported Event|LiRIS 400 mg_Randomized Study|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study.
59239|NCT01824160|B1|Baseline|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
59240|NCT01824160|P1|Participant Flow|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
59241|NCT01824160|O1|Outcome|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
59242|NCT01824160|E1|Reported Event|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
59243|NCT01823536|B7|Baseline|Total|Total of all reporting groups
59244|NCT01823536|B6|Baseline|Not Assigned|Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate “not assigned” group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study.
59245|NCT01823536|B5|Baseline|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59246|NCT01823536|B4|Baseline|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59247|NCT01823536|B3|Baseline|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59248|NCT01823536|B2|Baseline|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59249|NCT01823536|B1|Baseline|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59250|NCT01823536|P6|Participant Flow|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study."
59251|NCT01823536|P5|Participant Flow|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59252|NCT01823536|P4|Participant Flow|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59253|NCT01823536|P3|Participant Flow|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59254|NCT01823536|P2|Participant Flow|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59255|NCT01823536|P1|Participant Flow|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59256|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59257|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59258|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59259|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59260|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59261|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59262|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59263|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59264|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59265|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59266|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59267|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59268|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59269|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59270|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59271|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59272|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59273|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59274|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59275|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59276|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59277|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59278|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59279|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59280|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59281|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59282|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59421|NCT01822574|B4|Baseline|Total|Total of all reporting groups
59688|NCT01820559|O2|Outcome|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
59283|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59284|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59285|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59286|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59287|NCT01823536|E5|Reported Event|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
59288|NCT01823536|E4|Reported Event|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
59289|NCT01823536|E3|Reported Event|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
59290|NCT01823536|E2|Reported Event|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59291|NCT01823536|E1|Reported Event|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
59292|NCT01823341|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
59293|NCT01823341|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
59294|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59295|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59296|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59297|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59298|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59299|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59300|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59301|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59302|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59303|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59304|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59305|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59306|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59307|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59308|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59309|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59310|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59311|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59312|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59313|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59314|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59315|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59316|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59317|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59318|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59319|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59320|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59321|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59322|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59323|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59324|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59325|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59326|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59327|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59328|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59329|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59330|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59331|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59332|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
59333|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
59334|NCT01823341|E1|Reported Event|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
59335|NCT01823289|B1|Baseline|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59336|NCT01823289|P1|Participant Flow|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59337|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59338|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59339|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59340|NCT01823289|E1|Reported Event|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
59341|NCT01823224|B3|Baseline|Total|Total of all reporting groups
59342|NCT01823224|B2|Baseline|Group 2|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
59343|NCT01823224|B1|Baseline|Group 1|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
59344|NCT01823224|P2|Participant Flow|"Oral Acetaminophen 2 Capsules + IV Salt Water"|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
59345|NCT01823224|P1|Participant Flow|"IV Acetaminophen 1000mg + 2 Oral Sugar Pills"|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
59346|NCT01823224|O2|Outcome|Group 2|This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
59347|NCT01823224|O1|Outcome|Group 1|This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
59348|NCT01823224|O2|Outcome|Group 2|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks’ Lambda (P = 0.875). (Table 4 and Figure 1)
59689|NCT01820559|O1|Outcome|Placebo|"Placebo tablets~Placebo : Tablets"
59349|NCT01823224|O1|Outcome|Group 1|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
59350|NCT01823224|E2|Reported Event|Group 2|No adverse events
59351|NCT01823224|E1|Reported Event|Group 1|.Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen
59352|NCT01823146|B3|Baseline|Total|Total of all reporting groups
59353|NCT01823146|B2|Baseline|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN)
59354|NCT01823146|B1|Baseline|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
59355|NCT01823146|P2|Participant Flow|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
59356|NCT01823146|P1|Participant Flow|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
59357|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
59358|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
59359|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
59360|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
59361|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
59362|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
59363|NCT01823146|E2|Reported Event|Placebo Spray|"single dose of 24 IU saline, self-administered intranasally (IN)~Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)"
59364|NCT01823146|E1|Reported Event|Oxytocin Spray|"single dose of 24 IU oxytocin, self-administered intranasally (IN)~Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)"
59365|NCT01822899|B3|Baseline|Total|Total of all reporting groups
59366|NCT01822899|B2|Baseline|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
59367|NCT01822899|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
59368|NCT01822899|P2|Participant Flow|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
59369|NCT01822899|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
59370|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
59371|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
59372|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
59373|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
59374|NCT01822899|E2|Reported Event|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
59375|NCT01822899|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
59376|NCT01822691|B1|Baseline|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59377|NCT01822691|P1|Participant Flow|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59378|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59379|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59380|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59381|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59382|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59383|NCT01822691|E1|Reported Event|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
59384|NCT01822678|B4|Baseline|Total|Total of all reporting groups
59385|NCT01822678|B3|Baseline|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
59386|NCT01822678|B2|Baseline|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
59387|NCT01822678|B1|Baseline|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
59388|NCT01822678|P3|Participant Flow|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
59389|NCT01822678|P2|Participant Flow|ESL 600 mg|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
59390|NCT01822678|P1|Participant Flow|ESL 800 mg|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
59391|NCT01822678|O3|Outcome|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
59392|NCT01822678|O2|Outcome|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
59393|NCT01822678|O1|Outcome|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
59394|NCT01822678|E3|Reported Event|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
59395|NCT01822678|E2|Reported Event|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
59396|NCT01822678|E1|Reported Event|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
59397|NCT01822665|B1|Baseline|All Randomized Participants|All randomized participants in the study who took at least one treatment dose.
59398|NCT01822665|P1|Participant Flow|Overall Study|This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session.
59399|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
59400|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablet (400 mg/tablet), were administered TID, orally with water.
59401|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
59402|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
59403|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
59404|NCT01822665|O3|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
59405|NCT01822665|O2|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
59406|NCT01822665|O1|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
59407|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
59408|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
59409|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
59410|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
59411|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
59412|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
59413|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
59414|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
59415|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water.
59416|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) was administered QID, orally with water.
59417|NCT01822665|E4|Reported Event|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
59418|NCT01822665|E3|Reported Event|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
59419|NCT01822665|E2|Reported Event|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
59422|NCT01822574|B3|Baseline|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
59423|NCT01822574|B2|Baseline|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59424|NCT01822574|B1|Baseline|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59425|NCT01822574|P3|Participant Flow|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
59426|NCT01822574|P2|Participant Flow|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59427|NCT01822574|P1|Participant Flow|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59428|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
59429|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59430|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59431|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
59432|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59433|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59434|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
59435|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59436|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59437|NCT01822574|E3|Reported Event|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
102124|NCT01587079|O1|Outcome|GP MDI 18 μg (PT001)|18 μg
59438|NCT01822574|E2|Reported Event|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59439|NCT01822574|E1|Reported Event|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
59440|NCT01822535|B3|Baseline|Total|Total of all reporting groups
59441|NCT01822535|B2|Baseline|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
59442|NCT01822535|B1|Baseline|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
59443|NCT01822535|P2|Participant Flow|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
59444|NCT01822535|P1|Participant Flow|Tetraplegia|Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
59445|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
59446|NCT01822535|O2|Outcome|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
59447|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
59448|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
59449|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
59450|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
59451|NCT01822535|O1|Outcome|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
59452|NCT01822535|E3|Reported Event|Drug: Tetraplegia|Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
59453|NCT01822535|E2|Reported Event|No Drug: Able-bodied|Age- and gender-matched to individuals with tetraplegia.
59454|NCT01822535|E1|Reported Event|No Drug: Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
59455|NCT01822223|B3|Baseline|Total|Total of all reporting groups
59456|NCT01822223|B2|Baseline|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59457|NCT01822223|B1|Baseline|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59458|NCT01822223|P2|Participant Flow|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
59459|NCT01822223|P1|Participant Flow|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
59460|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
59461|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
59462|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
59463|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
59464|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
59465|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
59466|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59480|NCT01822119|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59481|NCT01822119|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59545|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59467|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59468|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59469|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59470|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59471|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59472|NCT01822223|E2|Reported Event|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59473|NCT01822223|E1|Reported Event|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
59474|NCT01822197|B1|Baseline|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59475|NCT01822197|P1|Participant Flow|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59476|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59477|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59478|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59479|NCT01822197|E1|Reported Event|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
59482|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59483|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59484|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59485|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59486|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59487|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59488|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59489|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59490|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59491|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59492|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59493|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59494|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59495|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59496|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59497|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59498|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59499|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59500|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59501|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59502|NCT01822119|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
59503|NCT01821963|B1|Baseline|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
59520|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59546|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59504|NCT01821963|P1|Participant Flow|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
59505|NCT01821963|O1|Outcome|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
59506|NCT01821963|E1|Reported Event|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
59507|NCT01821937|B3|Baseline|Total|Total of all reporting groups
59508|NCT01821937|B2|Baseline|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59509|NCT01821937|B1|Baseline|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59510|NCT01821937|P2|Participant Flow|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59511|NCT01821937|P1|Participant Flow|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59512|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59513|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59514|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59515|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59516|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59517|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59518|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59519|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59521|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59522|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59523|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59524|NCT01821937|E4|Reported Event|Faldaprevir 240 mg Multiple Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59525|NCT01821937|E3|Reported Event|Faldaprevir 240 mg Single Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
59526|NCT01821937|E2|Reported Event|Faldaprevir 120 mg Multiple Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
59527|NCT01821937|E1|Reported Event|Faldaprevir 120 mg Single Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
59528|NCT01821859|B1|Baseline|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
59529|NCT01821859|P1|Participant Flow|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
59530|NCT01821859|O1|Outcome|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
59531|NCT01821859|E1|Reported Event|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
59532|NCT01821807|B3|Baseline|Total|Total of all reporting groups
59533|NCT01821807|B2|Baseline|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
59534|NCT01821807|B1|Baseline|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
59535|NCT01821807|P2|Participant Flow|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
59536|NCT01821807|P1|Participant Flow|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
59537|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
59538|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
59539|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
59540|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
59541|NCT01821807|E2|Reported Event|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
59542|NCT01821807|E1|Reported Event|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
59543|NCT01821534|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59547|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59548|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59549|NCT01821534|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was administered.
59550|NCT01821378|B4|Baseline|Total|Total of all reporting groups
59551|NCT01821378|B3|Baseline|Placebo|Placebo: Once Daily
59552|NCT01821378|B2|Baseline|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59553|NCT01821378|B1|Baseline|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
59554|NCT01821378|P3|Participant Flow|Placebo|"Placebo Comparator 20 or 80 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
59555|NCT01821378|P2|Participant Flow|Lurasidone 80 mg - 160 mg|"Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
59556|NCT01821378|P1|Participant Flow|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
59557|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
59558|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
59559|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
59560|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
59561|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
59562|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
59563|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59564|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59565|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
59566|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
59567|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
59568|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59569|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59570|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
59571|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
59572|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
59573|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
59574|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
59575|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
59576|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59577|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59578|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
59579|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59580|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59581|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
59582|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59583|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59584|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
59585|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
59586|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
59587|NCT01821378|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
59588|NCT01821378|E3|Reported Event|Placebo|Placebo: Once Daily
59589|NCT01821378|E2|Reported Event|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).
59590|NCT01821378|E1|Reported Event|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
59591|NCT01821352|B3|Baseline|Total|Total of all reporting groups
59592|NCT01821352|B2|Baseline|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
59593|NCT01821352|B1|Baseline|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59594|NCT01821352|P2|Participant Flow|Placebo Laser|Placebo Laser device emits sham green light that has no therapeutic effect.
59595|NCT01821352|P1|Participant Flow|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59596|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
59597|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59598|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
59599|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59600|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
59601|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59602|NCT01821352|E2|Reported Event|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
59603|NCT01821352|E1|Reported Event|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
59604|NCT01821326|B1|Baseline|Patients With Obscure Gastrointestinal Bleeding|
59605|NCT01821326|P1|Participant Flow|Patients With Obscure Gastrointestinal Bleeding|
59606|NCT01821326|O1|Outcome|Patients With Obscure Gastrointestinal Bleeding|
59607|NCT01821326|E1|Reported Event|Patients With Obscure Gastrointestinal Bleeding|
59608|NCT01820364|B1|Baseline|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59609|NCT01820364|P2|Participant Flow|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59610|NCT01820364|P1|Participant Flow|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59611|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59612|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59613|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59614|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59615|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59616|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59617|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59618|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
59619|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59620|NCT01820364|E1|Reported Event|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
59621|NCT01821118|B3|Baseline|Total|Total of all reporting groups
59622|NCT01821118|B2|Baseline|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59623|NCT01821118|B1|Baseline|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59624|NCT01821118|P2|Participant Flow|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59625|NCT01821118|P1|Participant Flow|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59626|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59627|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59628|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59682|NCT01820559|B2|Baseline|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
59683|NCT01820559|B1|Baseline|Placebo|"Placebo tablets~Placebo : Tablets"
59629|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59630|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59631|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59632|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59633|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59634|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59635|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59636|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59637|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59638|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59639|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59640|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59641|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59642|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59643|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59644|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59645|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59646|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59647|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59648|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59649|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59650|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59651|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59652|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59684|NCT01820559|P3|Participant Flow|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
59653|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59654|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59655|NCT01821118|E2|Reported Event|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
59656|NCT01821118|E1|Reported Event|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
59657|NCT01821105|B1|Baseline|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59658|NCT01821105|P1|Participant Flow|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59659|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59660|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59661|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59662|NCT01821105|E1|Reported Event|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
59663|NCT01820585|B5|Baseline|Total|Total of all reporting groups
59664|NCT01820585|B4|Baseline|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59665|NCT01820585|B3|Baseline|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59666|NCT01820585|B2|Baseline|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59667|NCT01820585|B1|Baseline|Placebo|"Tablets~Placebo : Tablets"
59668|NCT01820585|P4|Participant Flow|ESL 1200 mg|ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
59669|NCT01820585|P3|Participant Flow|ESL 800 mg|ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route
59670|NCT01820585|P2|Participant Flow|ESL 400 mg|Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route.
59671|NCT01820585|P1|Participant Flow|Placebo|Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route.
59672|NCT01820585|O4|Outcome|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59673|NCT01820585|O3|Outcome|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59674|NCT01820585|O2|Outcome|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59675|NCT01820585|O1|Outcome|Placebo|"Tablets~Placebo : Tablets"
59676|NCT01820585|E4|Reported Event|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59677|NCT01820585|E3|Reported Event|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59678|NCT01820585|E2|Reported Event|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
59679|NCT01820585|E1|Reported Event|Placebo|"Tablets~Placebo : Tablets"
59680|NCT01820559|B4|Baseline|Total|Total of all reporting groups
59681|NCT01820559|B3|Baseline|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
59690|NCT01820559|E3|Reported Event|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
59691|NCT01820559|E2|Reported Event|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
59692|NCT01820559|E1|Reported Event|Placebo|"Placebo tablets~Placebo : Tablets"
59693|NCT01819935|B3|Baseline|Total|Total of all reporting groups
59694|NCT01819935|B2|Baseline|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59695|NCT01819935|B1|Baseline|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59696|NCT01819935|P2|Participant Flow|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59697|NCT01819935|P1|Participant Flow|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59698|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59699|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59700|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59701|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59702|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59703|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59704|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59705|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59706|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59707|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59708|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59709|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59710|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59711|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59712|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59713|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59714|NCT01819935|E2|Reported Event|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
59715|NCT01819935|E1|Reported Event|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
59716|NCT01819922|B1|Baseline|Overall Participants|All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.
59717|NCT01819922|P2|Participant Flow|Placebo Then PF-05175157|Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.
59718|NCT01819922|P1|Participant Flow|PF-05175157 Then Placebo|Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59719|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59720|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59721|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59722|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59723|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59724|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59725|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59726|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59727|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59728|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59729|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59730|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59731|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59732|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59733|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59734|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59735|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59736|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59737|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59738|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59739|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59740|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59741|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59742|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59743|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59744|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59745|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59746|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59747|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59748|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59749|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59750|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59751|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59752|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59753|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59754|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59755|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59756|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59757|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59758|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59811|NCT01819415|O3|Outcome|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
59759|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59760|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59761|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59762|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59763|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59764|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59765|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59766|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59767|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59768|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59769|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59770|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59771|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59772|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59773|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59774|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59775|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59776|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59777|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59778|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59779|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59780|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59781|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59782|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59812|NCT01819415|O2|Outcome|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
59783|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59784|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59785|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59786|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59787|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59788|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59789|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59790|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59791|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59792|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59793|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59794|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59795|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59796|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59797|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59798|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59799|NCT01819922|E2|Reported Event|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59800|NCT01819922|E1|Reported Event|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
59801|NCT01819415|B5|Baseline|Total|Total of all reporting groups
59802|NCT01819415|B4|Baseline|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
59803|NCT01819415|B3|Baseline|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
59804|NCT01819415|B2|Baseline|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
59805|NCT01819415|B1|Baseline|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
59806|NCT01819415|P4|Participant Flow|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
59807|NCT01819415|P3|Participant Flow|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
59808|NCT01819415|P2|Participant Flow|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
59809|NCT01819415|P1|Participant Flow|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
59810|NCT01819415|O4|Outcome|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
102125|NCT01587079|E8|Reported Event|Spiriva|18 μg
59813|NCT01819415|O1|Outcome|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
59814|NCT01819415|E4|Reported Event|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
59815|NCT01819415|E3|Reported Event|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
59816|NCT01819415|E2|Reported Event|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
59817|NCT01819415|E1|Reported Event|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
59818|NCT01819272|B7|Baseline|Total|Total of all reporting groups
59819|NCT01819272|B6|Baseline|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59820|NCT01819272|B5|Baseline|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59821|NCT01819272|B4|Baseline|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59822|NCT01819272|B3|Baseline|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59823|NCT01819272|B2|Baseline|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59824|NCT01819272|B1|Baseline|Placebo|Placebo once daily in the morning
59825|NCT01819272|P6|Participant Flow|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59826|NCT01819272|P5|Participant Flow|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59827|NCT01819272|P4|Participant Flow|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59828|NCT01819272|P3|Participant Flow|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59829|NCT01819272|P2|Participant Flow|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59830|NCT01819272|P1|Participant Flow|Placebo|Placebo once daily in the morning
59831|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59832|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59833|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59834|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59835|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59836|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
59837|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59838|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59839|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59840|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59841|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59842|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
59843|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59844|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59845|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59846|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59847|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59848|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
59849|NCT01819272|E6|Reported Event|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59850|NCT01819272|E5|Reported Event|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
59851|NCT01819272|E4|Reported Event|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59852|NCT01819272|E3|Reported Event|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59853|NCT01819272|E2|Reported Event|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
59854|NCT01819272|E1|Reported Event|Placebo|Placebo once daily in the morning
59855|NCT01819194|B1|Baseline|Dispensed Subjects|All subjects that were dispensed the study lens.
59856|NCT01819194|P1|Participant Flow|Overall|Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
59857|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
59858|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
59859|NCT01819194|E1|Reported Event|Senofilcon A, 38% Water|Senofilcon A, 38% water
59860|NCT01818700|B1|Baseline|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
60217|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
59861|NCT01818700|P1|Participant Flow|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59862|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59863|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59864|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59865|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59866|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|"This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
59867|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|This study is single study with buprenorphine. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
59868|NCT01818700|E1|Reported Event|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
59869|NCT01818596|B3|Baseline|Total|Total of all reporting groups
59870|NCT01818596|B2|Baseline|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59871|NCT01818596|B1|Baseline|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59872|NCT01818596|P2|Participant Flow|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59873|NCT01818596|P1|Participant Flow|Cohort 1 (Treatment-experienced)|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
59874|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59875|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59876|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59877|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59878|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59879|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59880|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59881|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59882|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59883|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59884|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59885|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59886|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59887|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59888|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59889|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59890|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59891|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59892|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59893|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59894|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59895|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59896|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
59897|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59898|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59899|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
59900|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
59901|NCT01818596|E2|Reported Event|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-naive participants
59902|NCT01818596|E1|Reported Event|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
59903|NCT01818414|B3|Baseline|Total|Total of all reporting groups
59904|NCT01818414|B2|Baseline|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
59905|NCT01818414|B1|Baseline|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
59906|NCT01818414|P2|Participant Flow|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
59907|NCT01818414|P1|Participant Flow|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
59908|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
59909|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
59910|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
59911|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
59912|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
59913|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
59914|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
59915|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
59916|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
59917|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
59918|NCT01818414|E2|Reported Event|Placebo Comparator: Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
59919|NCT01818414|E1|Reported Event|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
59920|NCT01818336|B1|Baseline|Safety Population|All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
59921|NCT01818336|P2|Participant Flow|Subjects in Retest Population|All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
59922|NCT01818336|P1|Participant Flow|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.
59923|NCT01818336|O1|Outcome|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
59924|NCT01818336|E3|Reported Event|Subjects With AE Related to Oral Amox Challenge|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
59925|NCT01818336|E2|Reported Event|Subjects With AE Related to Skin Testing|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s)."
59926|NCT01818336|E1|Reported Event|Safety Population-All Study-Emergent Adverse Events|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
59927|NCT01817855|B5|Baseline|Total|Total of all reporting groups
59928|NCT01817855|B4|Baseline|Placebo COPD|COPD Patients with Placebo, once daily
59929|NCT01817855|B3|Baseline|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
59930|NCT01817855|B2|Baseline|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
59931|NCT01817855|B1|Baseline|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
59932|NCT01817855|P4|Participant Flow|Placebo COPD|COPD Patients with Placebo, once daily
59933|NCT01817855|P3|Participant Flow|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
59934|NCT01817855|P2|Participant Flow|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
59935|NCT01817855|P1|Participant Flow|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
59936|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
59937|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
59938|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
59939|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
59940|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
59941|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
59942|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
59943|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
59944|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
59945|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
59946|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
59947|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
59948|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
59949|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
59950|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
59951|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
59952|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
59953|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
59954|NCT01817855|O4|Outcome|Placebo COPD|COPD Patients with Placebo, once daily
59955|NCT01817855|O3|Outcome|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
59956|NCT01817855|O2|Outcome|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
59957|NCT01817855|O1|Outcome|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
59958|NCT01817855|E4|Reported Event|Placebo COPD|COPD Patients with Placebo, once daily
59959|NCT01817855|E3|Reported Event|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
59960|NCT01817855|E2|Reported Event|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
59961|NCT01817855|E1|Reported Event|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
59962|NCT01817790|B3|Baseline|Total|Total of all reporting groups
59963|NCT01817790|B2|Baseline|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59964|NCT01817790|B1|Baseline|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59965|NCT01817790|P2|Participant Flow|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59966|NCT01817790|P1|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59967|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59968|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59969|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59970|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59971|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59972|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59973|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59974|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59975|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59976|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59977|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59978|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59979|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59980|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59981|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59982|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59983|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59984|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59985|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59986|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59987|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59988|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59989|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59990|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59991|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59992|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59993|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
59994|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59995|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
59996|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59997|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
59998|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
59999|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
60000|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
60001|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
60002|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
60003|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
60004|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
60005|NCT01817790|E2|Reported Event|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
60006|NCT01817790|E1|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
60007|NCT01817777|B3|Baseline|Total|Total of all reporting groups
60008|NCT01817777|B2|Baseline|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60009|NCT01817777|B1|Baseline|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60010|NCT01817777|P3|Participant Flow|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60011|NCT01817777|P2|Participant Flow|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60012|NCT01817777|P1|Participant Flow|Routine Metformin|Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.
60013|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60014|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60015|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60016|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60017|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60018|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60019|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60020|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60021|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60022|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60023|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60024|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60025|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60054|NCT01816685|E1|Reported Event|CPAP|"Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.~CPAP"
60055|NCT01816451|B4|Baseline|Total|Total of all reporting groups
102126|NCT01587079|E7|Reported Event|FF MDI 9.6 μg (PT005)|9.6 μg
60026|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60027|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60028|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60029|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60030|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60031|NCT01817777|E2|Reported Event|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
60032|NCT01817777|E1|Reported Event|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
60033|NCT01817764|B3|Baseline|Total|Total of all reporting groups
60034|NCT01817764|B2|Baseline|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
60035|NCT01817764|B1|Baseline|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
60036|NCT01817764|P2|Participant Flow|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
60037|NCT01817764|P1|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
60038|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
60039|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
60040|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
60041|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
60042|NCT01817764|E2|Reported Event|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
60043|NCT01817764|E1|Reported Event|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
60044|NCT01816685|B3|Baseline|Total|Total of all reporting groups
60045|NCT01816685|B2|Baseline|Routine Care|Routine care will be provided to the participant.
60046|NCT01816685|B1|Baseline|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
60047|NCT01816685|P2|Participant Flow|Routine Care|Routine care will be provided to the participant.
60048|NCT01816685|P1|Participant Flow|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
60049|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
60050|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
60051|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
60052|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
60053|NCT01816685|E2|Reported Event|Routine Care|Routine care will be provided to the participant.
60056|NCT01816451|B3|Baseline|Control|The control group did not do the running training program. Control did their normal physical activities.
60057|NCT01816451|B2|Baseline|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60058|NCT01816451|B1|Baseline|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60059|NCT01816451|P3|Participant Flow|Control|The control group did not do the running training program. Control did their normal physical activities.
60060|NCT01816451|P2|Participant Flow|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60061|NCT01816451|P1|Participant Flow|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60062|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60063|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60064|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60065|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60066|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60067|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60068|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60069|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60070|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60071|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60072|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60073|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60074|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60218|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
105625|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
60075|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60076|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60077|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60078|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60079|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60080|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60081|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60082|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60083|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60084|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60085|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60086|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60087|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60088|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60089|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60090|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60091|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
60113|NCT01816295|E2|Reported Event|Testosterone Solution - Double Blind|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period.
60092|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60093|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60094|NCT01816451|E3|Reported Event|Control|The control group did not do the running training program. Control did their normal physical activities.
60095|NCT01816451|E2|Reported Event|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
60096|NCT01816451|E1|Reported Event|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
60097|NCT01816295|B3|Baseline|Total|Total of all reporting groups
60098|NCT01816295|B2|Baseline|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60099|NCT01816295|B1|Baseline|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60100|NCT01816295|P2|Participant Flow|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60101|NCT01816295|P1|Participant Flow|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60102|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60103|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60104|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60105|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60106|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60107|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60108|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60109|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60110|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60111|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
60112|NCT01816295|E3|Reported Event|Testosterone Solution - OLE|Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks in optional OLE period.
60114|NCT01816295|E1|Reported Event|Placebo Solution - Double Blind|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
60115|NCT01816243|B1|Baseline|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60116|NCT01816243|P1|Participant Flow|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60117|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60118|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60119|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60120|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60121|NCT01816243|E1|Reported Event|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
60122|NCT01815840|B3|Baseline|Total|Total of all reporting groups
60123|NCT01815840|B2|Baseline|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60124|NCT01815840|B1|Baseline|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60125|NCT01815840|P2|Participant Flow|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60126|NCT01815840|P1|Participant Flow|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60127|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60128|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60129|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60130|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60131|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60132|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60133|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60134|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60215|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60135|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60136|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60137|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60138|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60139|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60140|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60141|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60142|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60143|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60144|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60145|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60146|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60147|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60148|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60149|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60150|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60151|NCT01815840|E2|Reported Event|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60152|NCT01815840|E1|Reported Event|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
60153|NCT01815736|B3|Baseline|Total|Total of all reporting groups
60154|NCT01815736|B2|Baseline|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60155|NCT01815736|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60156|NCT01815736|P2|Participant Flow|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60157|NCT01815736|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60158|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60159|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60160|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60216|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60161|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60162|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60163|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60164|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60165|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60166|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60167|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60168|NCT01815736|E2|Reported Event|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
60169|NCT01815736|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
60170|NCT01815671|B3|Baseline|Total|Total of all reporting groups
60171|NCT01815671|B2|Baseline|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60172|NCT01815671|B1|Baseline|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60173|NCT01815671|P2|Participant Flow|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60174|NCT01815671|P1|Participant Flow|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60175|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60176|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60177|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60178|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60179|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60180|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60181|NCT01815671|E2|Reported Event|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
60182|NCT01815671|E1|Reported Event|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
60183|NCT01815008|B1|Baseline|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
60184|NCT01815008|P1|Participant Flow|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
60185|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
60186|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
60187|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
60188|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
60189|NCT01815008|E1|Reported Event|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
60190|NCT01814878|B3|Baseline|Total|Total of all reporting groups
60191|NCT01814878|B2|Baseline|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60192|NCT01814878|B1|Baseline|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60193|NCT01814878|P2|Participant Flow|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60194|NCT01814878|P1|Participant Flow|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60195|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60196|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60197|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60198|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60199|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60200|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60201|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60202|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60203|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60204|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60205|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60206|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60207|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60208|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60209|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60210|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60211|NCT01814878|E2|Reported Event|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
60212|NCT01814878|E1|Reported Event|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
60213|NCT01814800|B1|Baseline|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60214|NCT01814800|P1|Participant Flow|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks~Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision."
60219|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60220|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60221|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60222|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60223|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60224|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60225|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60226|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60227|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60228|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60229|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60230|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60231|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60232|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60233|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60234|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60235|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60236|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60237|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60238|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60239|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60240|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60241|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60242|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60243|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60244|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60245|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60246|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60247|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60248|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60249|NCT01814800|E1|Reported Event|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
60250|NCT01814774|B1|Baseline|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60251|NCT01814774|P1|Participant Flow|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60252|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60253|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60254|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60255|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60256|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60257|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60258|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60259|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60260|NCT01814774|E2|Reported Event|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60261|NCT01814774|E1|Reported Event|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
60262|NCT01814761|B3|Baseline|Total|Total of all reporting groups
60263|NCT01814761|B2|Baseline|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60264|NCT01814761|B1|Baseline|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60265|NCT01814761|P2|Participant Flow|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60266|NCT01814761|P1|Participant Flow|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60711|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
60267|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60268|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60269|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60270|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60271|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60272|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60273|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60274|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60275|NCT01814761|E2|Reported Event|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60276|NCT01814761|E1|Reported Event|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
60277|NCT01814748|B3|Baseline|Total|Total of all reporting groups
60278|NCT01814748|B2|Baseline|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60279|NCT01814748|B1|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60280|NCT01814748|P2|Participant Flow|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60281|NCT01814748|P1|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60282|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60283|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60284|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60285|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60286|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60287|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60288|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60289|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60290|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60291|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60292|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60293|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60294|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60295|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60296|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60336|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60297|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60298|NCT01814748|E2|Reported Event|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60299|NCT01814748|E1|Reported Event|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
60300|NCT01814722|B4|Baseline|Total|Total of all reporting groups
60301|NCT01814722|B3|Baseline|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60302|NCT01814722|B2|Baseline|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60303|NCT01814722|B1|Baseline|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60304|NCT01814722|P3|Participant Flow|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60305|NCT01814722|P2|Participant Flow|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60306|NCT01814722|P1|Participant Flow|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60307|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60308|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60309|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60310|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60311|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60312|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60313|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60314|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60315|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60316|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60317|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60318|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60319|NCT01814722|E3|Reported Event|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
60320|NCT01814722|E2|Reported Event|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
60321|NCT01814722|E1|Reported Event|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
60322|NCT01814696|B3|Baseline|Total|Total of all reporting groups
60323|NCT01814696|B2|Baseline|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60324|NCT01814696|B1|Baseline|Control|Subjects will continue to receive usual medical care from their doctor(s).
60325|NCT01814696|P2|Participant Flow|Intervention|"Subjects will continue to receive usual medical care from their doctor(s).~Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60326|NCT01814696|P1|Participant Flow|Control|"Subjects will continue to receive usual medical care from their doctor(s).~Subjects will follow their normal medication management routine."
60327|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60328|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60329|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60330|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60331|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60332|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60333|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60334|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60335|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
105626|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
60337|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60338|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60339|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60340|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
60341|NCT01814696|E2|Reported Event|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
60342|NCT01814696|E1|Reported Event|Control|Subjects will continue to receive usual medical care from their doctor(s).
60343|NCT01814670|B1|Baseline|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60344|NCT01814670|P1|Participant Flow|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60345|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60346|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60347|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60348|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60349|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60350|NCT01814670|E1|Reported Event|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
60351|NCT01814553|B3|Baseline|Total|Total of all reporting groups
60352|NCT01814553|B2|Baseline|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60353|NCT01814553|B1|Baseline|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60354|NCT01814553|P2|Participant Flow|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60355|NCT01814553|P1|Participant Flow|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60356|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60357|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60358|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60423|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60359|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60360|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60361|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60362|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60363|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60364|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60365|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60366|NCT01814553|E2|Reported Event|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
60367|NCT01814553|E1|Reported Event|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
60368|NCT01814397|B1|Baseline|Women Starting Aromatase Inhibitor (AI) Therapy|There is only a single cohort. Postmenopausal women with estrogen receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60369|NCT01814397|P1|Participant Flow|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with hormone receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60370|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60371|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60372|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60424|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60373|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60374|NCT01814397|E1|Reported Event|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
60375|NCT01814332|B3|Baseline|Total|Total of all reporting groups
60376|NCT01814332|B2|Baseline|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60377|NCT01814332|B1|Baseline|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60378|NCT01814332|P2|Participant Flow|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60379|NCT01814332|P1|Participant Flow|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60380|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60381|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60382|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60383|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60384|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60385|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60386|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60387|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60388|NCT01814332|E2|Reported Event|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
60389|NCT01814332|E1|Reported Event|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
60390|NCT01814137|B3|Baseline|Total|Total of all reporting groups
60391|NCT01814137|B2|Baseline|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60392|NCT01814137|B1|Baseline|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60393|NCT01814137|P2|Participant Flow|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60394|NCT01814137|P1|Participant Flow|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60425|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60395|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60396|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60397|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60398|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60399|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60400|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60401|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60426|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60427|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60428|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
105627|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
60402|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60403|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60404|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60405|NCT01814137|E2|Reported Event|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
60406|NCT01814137|E1|Reported Event|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
60407|NCT01813890|B4|Baseline|Total|Total of all reporting groups
60408|NCT01813890|B3|Baseline|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60409|NCT01813890|B2|Baseline|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60410|NCT01813890|B1|Baseline|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60411|NCT01813890|P3|Participant Flow|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60412|NCT01813890|P2|Participant Flow|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60413|NCT01813890|P1|Participant Flow|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60414|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60415|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60416|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60417|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60418|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60419|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60420|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60421|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60422|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60871|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60429|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60430|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60431|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60432|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60433|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60434|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60435|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60436|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60437|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60438|NCT01813890|E3|Reported Event|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
60439|NCT01813890|E2|Reported Event|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
60440|NCT01813890|E1|Reported Event|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
60441|NCT01813721|B1|Baseline|Primary Analysis Set|
60442|NCT01813721|P1|Participant Flow|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
60443|NCT01813721|O1|Outcome|At or Above Investigator Threshold|
60444|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
60445|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
60446|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
60447|NCT01813721|O1|Outcome|Breast Cancer|
60448|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
60449|NCT01813721|O3|Outcome|Private Center|
60450|NCT01813721|O2|Outcome|General Hospital|
60451|NCT01813721|O1|Outcome|University Hospital|
60452|NCT01813721|O2|Outcome|> 10 Years|
60453|NCT01813721|O1|Outcome|≤ 10 Years|
60454|NCT01813721|O2|Outcome|Hematologist|
60455|NCT01813721|O1|Outcome|Medical Oncologist|
60456|NCT01813721|O4|Outcome|France|
60457|NCT01813721|O3|Outcome|Romania|
60458|NCT01813721|O2|Outcome|Greece|
60459|NCT01813721|O1|Outcome|Poland|
60460|NCT01813721|O2|Outcome|General Hospital|
60461|NCT01813721|O1|Outcome|University Hospital|
60462|NCT01813721|O2|Outcome|> 10 Years|
60463|NCT01813721|O1|Outcome|≤ 10 Years|
60464|NCT01813721|O1|Outcome|Medical Oncologist|
60465|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
60466|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
60467|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
60468|NCT01813721|O1|Outcome|Breast Cancer|
60469|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
60470|NCT01813721|O3|Outcome|Private Center|
60471|NCT01813721|O2|Outcome|General Hospital|
60472|NCT01813721|O1|Outcome|University Hospital|
60473|NCT01813721|O2|Outcome|> 10 Years|
60474|NCT01813721|O1|Outcome|≤ 10 Years|
60475|NCT01813721|O2|Outcome|Hematologist|
60476|NCT01813721|O1|Outcome|Medical Oncologist|
60477|NCT01813721|O4|Outcome|France|
60478|NCT01813721|O3|Outcome|Romania|
60479|NCT01813721|O2|Outcome|Greece|
60480|NCT01813721|O1|Outcome|Poland|
60481|NCT01813721|O1|Outcome|Primary Analysis Set|
60482|NCT01813721|O2|Outcome|General Hospital|
60483|NCT01813721|O1|Outcome|University Hospital|
60484|NCT01813721|O2|Outcome|> 10 Years|
60485|NCT01813721|O1|Outcome|≤ 10 Years|
60486|NCT01813721|O1|Outcome|Medical Oncologist|
60487|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
60488|NCT01813721|O1|Outcome|Primary Analysis Set|
60489|NCT01813721|O1|Outcome|Primary Analysis Set|
60490|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
60491|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
60492|NCT01813721|E1|Reported Event|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
60493|NCT01813019|B3|Baseline|Total|Total of all reporting groups
60494|NCT01813019|B2|Baseline|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
60495|NCT01813019|B1|Baseline|Placebo|Matching Placebo b.i.d. dosing
60496|NCT01813019|P2|Participant Flow|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
60497|NCT01813019|P1|Participant Flow|Placebo|Matching Placebo b.i.d. dosing
60498|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
60499|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
60500|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
60501|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
60524|NCT01812707|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60502|NCT01813019|E2|Reported Event|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
60503|NCT01813019|E1|Reported Event|Placebo|Matching Placebo b.i.d. dosing
60504|NCT01812837|B4|Baseline|Total|Total of all reporting groups
60505|NCT01812837|B3|Baseline|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60506|NCT01812837|B2|Baseline|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60507|NCT01812837|B1|Baseline|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60508|NCT01812837|P3|Participant Flow|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60509|NCT01812837|P2|Participant Flow|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60510|NCT01812837|P1|Participant Flow|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60511|NCT01812837|O3|Outcome|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60512|NCT01812837|O2|Outcome|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60513|NCT01812837|O1|Outcome|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60514|NCT01812837|E3|Reported Event|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60515|NCT01812837|E2|Reported Event|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60516|NCT01812837|E1|Reported Event|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
60517|NCT01812707|B5|Baseline|Total|Total of all reporting groups
60518|NCT01812707|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60519|NCT01812707|B3|Baseline|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60520|NCT01812707|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60521|NCT01812707|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60522|NCT01812707|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60523|NCT01812707|P3|Participant Flow|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60525|NCT01812707|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
60526|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60527|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60528|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60529|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12 weeks in combination with atorvastatin stable dose.
60530|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60531|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60532|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60533|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60534|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60535|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60536|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60537|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60538|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60539|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60540|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60541|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60542|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60543|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60544|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60545|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60546|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60547|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60548|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60549|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60550|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60551|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60552|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60553|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
60554|NCT01812707|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60555|NCT01812707|E3|Reported Event|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60556|NCT01812707|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
60557|NCT01812707|E1|Reported Event|Placebo|Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
60558|NCT01812681|B3|Baseline|Total|Total of all reporting groups
60559|NCT01812681|B2|Baseline|Normal Vitamin D|The premature infants with normal vitamin D level
60560|NCT01812681|B1|Baseline|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
60561|NCT01812681|P2|Participant Flow|Normal Vitamin D|The premature infants with normal vitamin D level
60562|NCT01812681|P1|Participant Flow|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
60563|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
60564|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
60565|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
60566|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
60567|NCT01812681|E2|Reported Event|Normal Vitamin D|The premature infants with normal vitamin D level
60568|NCT01812681|E1|Reported Event|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
60569|NCT01812655|B4|Baseline|Total|Total of all reporting groups
60570|NCT01812655|B3|Baseline|Standard Care Provided by the Nurses|
60571|NCT01812655|B2|Baseline|Passive Distraction|watching a movie
60572|NCT01812655|B1|Baseline|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
60573|NCT01812655|P3|Participant Flow|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
60574|NCT01812655|P2|Participant Flow|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
60575|NCT01812655|P1|Participant Flow|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
61125|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
60576|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
60577|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
60578|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
60579|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
60580|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
60581|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
60582|NCT01812655|O3|Outcome|Standard Care Provided by the Nurses|
60583|NCT01812655|O2|Outcome|Passive Distraction|watching a movie
60584|NCT01812655|O1|Outcome|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
60585|NCT01812655|E3|Reported Event|UC Provided by the Nurses|
60586|NCT01812655|E2|Reported Event|Passive Distraction|watching a movie
60587|NCT01812655|E1|Reported Event|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
60588|NCT01812473|B3|Baseline|Total|Total of all reporting groups
60589|NCT01812473|B2|Baseline|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
60590|NCT01812473|B1|Baseline|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
60591|NCT01812473|P2|Participant Flow|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
60592|NCT01812473|P1|Participant Flow|Patients Admitted to the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
60593|NCT01812473|O2|Outcome|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
60594|NCT01812473|O1|Outcome|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
60595|NCT01812473|E2|Reported Event|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
60596|NCT01812473|E1|Reported Event|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
60597|NCT01812044|B4|Baseline|Total|Total of all reporting groups
60598|NCT01812044|B3|Baseline|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60599|NCT01812044|B2|Baseline|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60600|NCT01812044|B1|Baseline|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60601|NCT01812044|P3|Participant Flow|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60602|NCT01812044|P2|Participant Flow|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60603|NCT01812044|P1|Participant Flow|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60604|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60605|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60606|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60607|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60608|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60609|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60610|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60611|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60612|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60613|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60614|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60615|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60616|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60617|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60618|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60619|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60671|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
105628|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
60620|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60621|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60622|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60623|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60624|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60625|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60626|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60627|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60628|NCT01812044|E3|Reported Event|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
60629|NCT01812044|E2|Reported Event|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
60630|NCT01812044|E1|Reported Event|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
60631|NCT01811953|B7|Baseline|Total|Total of all reporting groups
60632|NCT01811953|B6|Baseline|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60633|NCT01811953|B5|Baseline|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60634|NCT01811953|B4|Baseline|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60635|NCT01811953|B3|Baseline|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60636|NCT01811953|B2|Baseline|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60637|NCT01811953|B1|Baseline|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60638|NCT01811953|P6|Participant Flow|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60639|NCT01811953|P5|Participant Flow|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
61126|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
60640|NCT01811953|P4|Participant Flow|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60641|NCT01811953|P3|Participant Flow|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60642|NCT01811953|P2|Participant Flow|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60643|NCT01811953|P1|Participant Flow|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
60644|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60645|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60646|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60647|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60648|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60649|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60650|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60651|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60652|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60653|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60654|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60655|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60656|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60657|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60658|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60659|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60660|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60661|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60662|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60663|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60664|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60665|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60666|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60667|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60668|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60669|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60670|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60710|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
60672|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60673|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60674|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60675|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60676|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60677|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60678|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60679|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60680|NCT01811953|E6|Reported Event|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
60681|NCT01811953|E5|Reported Event|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
60682|NCT01811953|E4|Reported Event|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60683|NCT01811953|E3|Reported Event|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
60684|NCT01811953|E2|Reported Event|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60685|NCT01811953|E1|Reported Event|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
60686|NCT01811706|B1|Baseline|All Study Participants|
60687|NCT01811706|P2|Participant Flow|Placebo, Then Dalfampridine|"Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
60688|NCT01811706|P1|Participant Flow|Dalfampridine and Then Placebo|"Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
60689|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
60690|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
60691|NCT01811706|O2|Outcome|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
60692|NCT01811706|O1|Outcome|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
60693|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
60694|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
60695|NCT01811706|E2|Reported Event|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
60696|NCT01811706|E1|Reported Event|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
60697|NCT01811680|B1|Baseline|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
60698|NCT01811680|P1|Participant Flow|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
60699|NCT01811680|O1|Outcome|Supervised Treadmill Training|Supervised treadmill training on variable sensing treadmill.
60700|NCT01811680|O1|Outcome|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
60701|NCT01811680|E1|Reported Event|Supervised Treadmill Training|Research Intervention: Supervised treadmill training on variable sensing treadmill.
60702|NCT01811485|B4|Baseline|Total|Total of all reporting groups
60703|NCT01811485|B3|Baseline|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60704|NCT01811485|B2|Baseline|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
60705|NCT01811485|B1|Baseline|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
60706|NCT01811485|P3|Participant Flow|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60707|NCT01811485|P2|Participant Flow|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
60708|NCT01811485|P1|Participant Flow|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
60709|NCT01811485|O3|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
61186|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
60712|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60713|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
60714|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60715|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
60716|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
60717|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
60718|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60719|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
60720|NCT01811485|E4|Reported Event|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
60721|NCT01811485|E3|Reported Event|LMF237 50/500mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
60722|NCT01811485|E2|Reported Event|LMF237 50/250mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
60723|NCT01811485|E1|Reported Event|POOLED LMF237|All patients who has received LMF237
60724|NCT01811472|B4|Baseline|Total|Total of all reporting groups
60725|NCT01811472|B3|Baseline|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60726|NCT01811472|B2|Baseline|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60727|NCT01811472|B1|Baseline|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60728|NCT01811472|P3|Participant Flow|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60729|NCT01811472|P2|Participant Flow|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60730|NCT01811472|P1|Participant Flow|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60731|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60732|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60733|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60734|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60735|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60736|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60770|NCT01811472|E4|Reported Event|Pooled Pradigastat (LCQ908)|This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
61187|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
60737|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60738|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60739|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60740|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60741|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60742|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60743|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60744|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60745|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60746|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60747|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60748|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60749|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60750|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60751|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60752|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60828|NCT01810692|B1|Baseline|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60832|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60753|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60754|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60755|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60756|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60757|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60758|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60759|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60760|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60761|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60762|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60763|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60764|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60765|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60766|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60767|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60768|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60769|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60771|NCT01811472|E3|Reported Event|Pradigastat (LCQ908) 10mg/20 mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60772|NCT01811472|E2|Reported Event|Pradigastat (LCQ908) 5mg /10 mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60773|NCT01811472|E1|Reported Event|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
60774|NCT01811303|B1|Baseline|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
60775|NCT01811303|P4|Participant Flow|Treatment, Placebo, Treatment, Placebo|The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
60776|NCT01811303|P3|Participant Flow|Placebo, Treatment, Placebo, Treatment|The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
60777|NCT01811303|P2|Participant Flow|Treatment, Treatment, Placebo, Placebo|The subjects receive treatment in the first two interventions
60778|NCT01811303|P1|Participant Flow|Placebo, Placebo, Treatment, Treatment|The subjects receive placebo in the first two interventions.
60779|NCT01811303|O2|Outcome|Control|Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
60780|NCT01811303|O1|Outcome|D-fagomine|Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.
60781|NCT01811303|O2|Outcome|Change D-fagomine/Control AUC at 120 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
60782|NCT01811303|O1|Outcome|Change D-fagomine/Control AUC at 60 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
60783|NCT01811303|E2|Reported Event|Placebo - Control (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
60784|NCT01811303|E1|Reported Event|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water.
60785|NCT01811238|B1|Baseline|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60786|NCT01811238|P1|Participant Flow|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60787|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60788|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60789|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60790|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60791|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/naloxone: Targin 5mg, 10mg, 20mg up to 40mg b.i.d"
60792|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60793|NCT01811238|E1|Reported Event|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
60794|NCT01810952|B3|Baseline|Total|Total of all reporting groups
60795|NCT01810952|B2|Baseline|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
60796|NCT01810952|B1|Baseline|Glargine/Lispro Insulin Arm|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
60797|NCT01810952|P2|Participant Flow|Glargine/Lispro/NPH Insulin|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
60829|NCT01810692|P2|Participant Flow|Hirobriz/Onbrez/Oslif Breezhaler|Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60830|NCT01810692|P1|Participant Flow|Spiriva Respimat|Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60831|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60798|NCT01810952|P1|Participant Flow|Glargine/Lispro Insulin|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
60799|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
60800|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
60801|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
60802|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
60803|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Insulin (units)/kg body weight
60804|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Insulin (units)/kg body weight
60805|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Last Full Day of Protocol
60806|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Last Full Day of Protocol
60807|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|"Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day."
60808|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|"The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL."
60809|NCT01810952|E2|Reported Event|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
60810|NCT01810952|E1|Reported Event|Glargine/Lispro Insulin Arm|"The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
60811|NCT01810939|B1|Baseline|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
60812|NCT01810939|P3|Participant Flow|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
60813|NCT01810939|P2|Participant Flow|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
60814|NCT01810939|P1|Participant Flow|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
60815|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
60816|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
60817|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. The dose of patiromer could be titrated based on participant's serum potassium response.
60818|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
60819|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
60820|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
60821|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
60822|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
60823|NCT01810939|E3|Reported Event|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
60824|NCT01810939|E2|Reported Event|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
60825|NCT01810939|E1|Reported Event|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
60826|NCT01810692|B3|Baseline|Total|Total of all reporting groups
60827|NCT01810692|B2|Baseline|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60870|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60833|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60834|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60835|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60836|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60837|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60838|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60839|NCT01810692|E2|Reported Event|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
60840|NCT01810692|E1|Reported Event|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
60841|NCT01810666|B1|Baseline|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60842|NCT01810666|P1|Participant Flow|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60843|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60844|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60845|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60846|NCT01810666|E1|Reported Event|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
60847|NCT01810380|B4|Baseline|Total|Total of all reporting groups
60848|NCT01810380|B3|Baseline|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60849|NCT01810380|B2|Baseline|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60850|NCT01810380|B1|Baseline|Placebo|Placebo: Once daily as tablets and capsules, orally
60851|NCT01810380|P3|Participant Flow|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60852|NCT01810380|P2|Participant Flow|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60853|NCT01810380|P1|Participant Flow|Placebo|Placebo: Once daily as tablets and capsules, orally
60854|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60855|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60856|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60857|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60858|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60859|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60860|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60861|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60862|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60863|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60864|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60865|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60866|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60867|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60868|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60869|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60872|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60873|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60874|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60875|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60876|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60877|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60878|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60879|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60880|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60881|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60882|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60883|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60884|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60885|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60886|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60887|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60888|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60889|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60890|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60891|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60892|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60893|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60894|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60895|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60896|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60897|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60898|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60899|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60900|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60901|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60902|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60903|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60904|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60905|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60906|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60907|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
60908|NCT01810380|E3|Reported Event|Quetiapine|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
60909|NCT01810380|E2|Reported Event|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
60910|NCT01810380|E1|Reported Event|Placebo|Placebo: Once daily as tablets and capsules, orally
60911|NCT01810302|B3|Baseline|Total|Total of all reporting groups
60912|NCT01810302|B2|Baseline|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
60913|NCT01810302|B1|Baseline|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
60914|NCT01810302|P2|Participant Flow|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
60915|NCT01810302|P1|Participant Flow|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
60916|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
60917|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
60918|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
61188|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
60919|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
60920|NCT01810302|E2|Reported Event|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
60921|NCT01810302|E1|Reported Event|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
60922|NCT01810263|B3|Baseline|Total|Total of all reporting groups
60923|NCT01810263|B2|Baseline|Control|no intervention
60924|NCT01810263|B1|Baseline|High Protein Supplement|high protein supplement given
60925|NCT01810263|P2|Participant Flow|Control|Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
60926|NCT01810263|P1|Participant Flow|High Protein Supplement|"Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.~(As a result, additional calories are 600kcal a day)"
60927|NCT01810263|O2|Outcome|Control|no intervention
60928|NCT01810263|O1|Outcome|High Protein Supplement|high protein supplement given
60929|NCT01810263|E2|Reported Event|Control|no intervention
60930|NCT01810263|E1|Reported Event|High Protein Supplement|high protein supplement given
60931|NCT01810042|B1|Baseline|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60932|NCT01810042|P1|Participant Flow|Ranibizumab|"Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60933|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60934|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60935|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60936|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60937|NCT01810042|E1|Reported Event|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
60938|NCT01809938|B1|Baseline|Entire Study Population|Includes all participants in this crossover trial
60939|NCT01809938|P2|Participant Flow|Tea With Milk First Then Black Tea|Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
60940|NCT01809938|P1|Participant Flow|Black Tea First, Then Tea With Milk|Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed
60941|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
60942|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
60943|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
60944|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
60945|NCT01809938|E1|Reported Event|Entire Study Population|Includes all participants in this crossover trial
60946|NCT01809834|B1|Baseline|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60947|NCT01809834|P1|Participant Flow|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously~Etafilcon A~Stenfilcon A"
60948|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60949|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60950|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60951|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60952|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60953|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60954|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60955|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60956|NCT01809834|O1|Outcome|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60957|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
61189|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
60958|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60959|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60960|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60961|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60962|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60963|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60964|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60965|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60966|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60967|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60968|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60969|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60970|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
60971|NCT01809834|E1|Reported Event|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other~Etafilcon A~Stenfilcon A"
60972|NCT01809639|B3|Baseline|Total|Total of all reporting groups
60973|NCT01809639|B2|Baseline|Placebo|Placebo: Standard placebo for 5 days
60974|NCT01809639|B1|Baseline|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
60975|NCT01809639|P2|Participant Flow|Placebo|Placebo: Standard placebo for 5 days
60976|NCT01809639|P1|Participant Flow|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
60977|NCT01809639|O2|Outcome|Placebo|Placebo: Standard placebo for 5 days
60978|NCT01809639|O1|Outcome|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
60979|NCT01809639|E2|Reported Event|Placebo|Placebo: Standard placebo for 5 days
60980|NCT01809639|E1|Reported Event|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
60981|NCT01808339|B1|Baseline|FF 100 µg AM/FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in either of the six sequences: ABC , ACB, BAC, BCA, CAB, or CBA. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI), during treatment B: participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI during treatment C: participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60982|NCT01808339|P6|Participant Flow|Placebo/FF 100 µg PM /FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence CBA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60983|NCT01808339|P5|Participant Flow|Placebo/FF 100 µg AM/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence CAB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60984|NCT01808339|P4|Participant Flow|FF 100 µg PM /Placebo/FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence BCA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60985|NCT01808339|P3|Participant Flow|FF 100 µg PM /FF 100 µg AM/Placebo|Participants received 3 treatments (A, B, and C) in sequence BAC. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
61118|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61119|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
60986|NCT01808339|P2|Participant Flow|FF 100 µg AM/Placebo/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence ACB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60987|NCT01808339|P1|Participant Flow|FF 100 µg AM /FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in sequence ABC. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI). During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60988|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60989|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60990|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60991|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60992|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60993|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60994|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60995|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60996|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60997|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60998|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
60999|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
61000|NCT01808339|E3|Reported Event|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
61001|NCT01808339|E2|Reported Event|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
61002|NCT01808339|E1|Reported Event|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
61035|NCT01809327|B1|Baseline|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61036|NCT01809327|P5|Participant Flow|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61120|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61121|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61003|NCT01808326|B1|Baseline|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61004|NCT01808326|P1|Participant Flow|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61005|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61006|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61007|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61008|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61009|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61037|NCT01809327|P4|Participant Flow|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61122|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61010|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61011|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61012|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61013|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61014|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61015|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61016|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61038|NCT01809327|P3|Participant Flow|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61123|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61017|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61018|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61019|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61020|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61021|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61022|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61023|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61039|NCT01809327|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61124|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61024|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61025|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61026|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61027|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61028|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61029|NCT01808326|E1|Reported Event|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
61030|NCT01809327|B6|Baseline|Total|Total of all reporting groups
61031|NCT01809327|B5|Baseline|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61032|NCT01809327|B4|Baseline|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61033|NCT01809327|B3|Baseline|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61034|NCT01809327|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61115|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61040|NCT01809327|P1|Participant Flow|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61041|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61042|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61043|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61044|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61045|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61046|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61047|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61048|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61049|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61050|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61051|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61052|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61053|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61054|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61055|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61056|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61057|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61058|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61059|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61060|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61061|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61116|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61117|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61062|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61063|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61064|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61065|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61066|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61067|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61068|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61069|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61070|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61071|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61072|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61073|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61074|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61075|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61076|NCT01809327|E5|Reported Event|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61077|NCT01809327|E4|Reported Event|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
61078|NCT01809327|E3|Reported Event|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61079|NCT01809327|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
61080|NCT01809327|E1|Reported Event|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
61081|NCT01809314|B1|Baseline|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61082|NCT01809314|P1|Participant Flow|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61083|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61084|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61085|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61086|NCT01809314|E1|Reported Event|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
61087|NCT01809262|B1|Baseline|Study Total|Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
61088|NCT01809262|P10|Participant Flow|Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61089|NCT01809262|P9|Participant Flow|Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg|Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61090|NCT01809262|P8|Participant Flow|Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
61091|NCT01809262|P7|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61092|NCT01809262|P6|Participant Flow|Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
61093|NCT01809262|P5|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61094|NCT01809262|P4|Participant Flow|Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61095|NCT01809262|P3|Participant Flow|Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg|Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61096|NCT01809262|P2|Participant Flow|Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg|Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61097|NCT01809262|P1|Participant Flow|Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg|Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
61098|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61099|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61100|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61101|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61102|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61103|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61104|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61105|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61106|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61107|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61108|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61109|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61110|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61111|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61112|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61113|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61114|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61127|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61128|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61129|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61130|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61131|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61132|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61133|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61134|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61135|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61136|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61137|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61138|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61139|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61140|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61141|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61142|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61143|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61144|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61145|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61146|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61147|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61148|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61149|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61150|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61151|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61152|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61153|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61154|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61155|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61156|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61157|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61158|NCT01809262|E5|Reported Event|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
61159|NCT01809262|E4|Reported Event|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
61160|NCT01809262|E3|Reported Event|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
61161|NCT01809262|E2|Reported Event|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
61162|NCT01809262|E1|Reported Event|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
61163|NCT01809197|B3|Baseline|Total|Total of all reporting groups
61164|NCT01809197|B2|Baseline|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
61165|NCT01809197|B1|Baseline|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
61166|NCT01809197|P2|Participant Flow|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
61167|NCT01809197|P1|Participant Flow|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
61168|NCT01809197|O2|Outcome|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
61169|NCT01809197|O1|Outcome|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
61170|NCT01809197|E2|Reported Event|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
61171|NCT01809197|E1|Reported Event|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
61172|NCT01809106|B5|Baseline|Total|Total of all reporting groups
61173|NCT01809106|B4|Baseline|Fentanyl|Fentanyl: 25 microg/h
61174|NCT01809106|B3|Baseline|Buprenorphine|Buprenorphine: 35 microg/h
61175|NCT01809106|B2|Baseline|Oxycodone|Oxycodone: 40 mg /24 ore
61176|NCT01809106|B1|Baseline|Morphine|Morphine: 60 mg /24 ore
61177|NCT01809106|P4|Participant Flow|Fentanyl|Fentanyl: 25 microg/h
61178|NCT01809106|P3|Participant Flow|Buprenorphine|Buprenorphine: 35 microg/h
61179|NCT01809106|P2|Participant Flow|Oxycodone|Oxycodone: 40 mg /24 ore
61180|NCT01809106|P1|Participant Flow|Morphine|Morphine: 60 mg /24 ore
61181|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
61182|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
61183|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
61184|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
61185|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
61194|NCT01809106|E3|Reported Event|Buprenorphine|Buprenorphine: 35 microg/h
61195|NCT01809106|E2|Reported Event|Oxycodone|Oxycodone: 40 mg /24 ore
61196|NCT01809106|E1|Reported Event|Morphine|Morphine: 60 mg /24 ore
61197|NCT01809054|B3|Baseline|Total|Total of all reporting groups
61198|NCT01809054|B2|Baseline|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
61199|NCT01809054|B1|Baseline|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
61200|NCT01809054|P2|Participant Flow|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
61201|NCT01809054|P1|Participant Flow|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
61202|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
61203|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
61204|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
61205|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
61206|NCT01809054|E2|Reported Event|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
61207|NCT01809054|E1|Reported Event|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
61208|NCT01808963|B1|Baseline|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
61209|NCT01808963|P1|Participant Flow|Study Group|Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
61210|NCT01808963|O1|Outcome|Study Group|Joules per minute
61211|NCT01808963|E1|Reported Event|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
61212|NCT01808950|B4|Baseline|Total|Total of all reporting groups
61213|NCT01808950|B3|Baseline|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
61214|NCT01808950|B2|Baseline|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
61215|NCT01808950|B1|Baseline|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
61216|NCT01808950|P3|Participant Flow|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
61217|NCT01808950|P2|Participant Flow|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
61218|NCT01808950|P1|Participant Flow|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
61219|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C: shave biopsy of BCC followed by single 100mg dose"
61220|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
61221|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
61222|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
61223|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
61224|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
61629|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61225|NCT01808950|E3|Reported Event|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
61226|NCT01808950|E2|Reported Event|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
61227|NCT01808950|E1|Reported Event|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
61228|NCT01808755|B1|Baseline|All Study Participamts|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
61229|NCT01808755|P2|Participant Flow|Trimethoprim/Sulfamethoxazole First, Then D Mannose|Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
61230|NCT01808755|P1|Participant Flow|D Mannose First, Then Trimethoprim/Sulfamethoxazole|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
61231|NCT01808755|O2|Outcome|Trimethoprim /Sulfamethoxazole First, Then D Mannose|trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
61232|NCT01808755|O1|Outcome|D Mannose First, Then Trimethoprim /Sulfamethoxazole|1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
61233|NCT01808755|E1|Reported Event|D Mannose Versus Antibiotic|"1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks~D Mannose : D Mannose versus oral antibiotic~Antibiotic : length of treatment: 5-7 days"
61234|NCT01808651|B4|Baseline|Total|Total of all reporting groups
61235|NCT01808651|B3|Baseline|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61236|NCT01808651|B2|Baseline|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61237|NCT01808651|B1|Baseline|PLA/FLX (Placebo/Fluoxetine)|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61238|NCT01808651|P3|Participant Flow|FLX40/FLX|"Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
61239|NCT01808651|P2|Participant Flow|FLX20/FLX|"Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
61240|NCT01808651|P1|Participant Flow|PLA/FLX|"Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."
61241|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61242|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61243|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61244|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61245|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61246|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61247|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61248|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61249|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61250|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61251|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61252|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61253|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61254|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61255|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61256|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61257|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61258|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61259|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61260|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61261|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61262|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61263|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61264|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61265|NCT01808651|E6|Reported Event|Study Period 2 Discontinued From FLX40/FLX|Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
61266|NCT01808651|E5|Reported Event|Study Period 2 Discontinued From FLX20/FLX|Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
61267|NCT01808651|E4|Reported Event|Study Period 2 Discontinued From PLA/FLX|Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
61268|NCT01808651|E3|Reported Event|Study Period 1 FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61269|NCT01808651|E2|Reported Event|Study Period 1 FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61270|NCT01808651|E1|Reported Event|Study Period 1 PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
61271|NCT01808612|B4|Baseline|Total|Total of all reporting groups
61272|NCT01808612|B3|Baseline|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61273|NCT01808612|B2|Baseline|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61274|NCT01808612|B1|Baseline|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61275|NCT01808612|P3|Participant Flow|Placebo|"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
61276|NCT01808612|P2|Participant Flow|40 mg Fluoxetine|"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
61277|NCT01808612|P1|Participant Flow|20 mg Fluoxetine|"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
61278|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61279|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61280|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61281|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61282|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61283|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61284|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61285|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61286|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61287|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61288|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61289|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61290|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61291|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61292|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61293|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61294|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61295|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61296|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
61297|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61298|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
61299|NCT01808612|E6|Reported Event|Placebo (Discontinuation From 40 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
61300|NCT01808612|E5|Reported Event|Placebo (Discontinuation From 20 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
61301|NCT01808612|E4|Reported Event|Placebo (Discontinuation From Placebo)|AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
61302|NCT01808612|E3|Reported Event|40 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
61303|NCT01808612|E2|Reported Event|20 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
61304|NCT01808612|E1|Reported Event|Placebo (Treatment Period)|Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period
61305|NCT01808547|B3|Baseline|Total|Total of all reporting groups
61306|NCT01808547|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
61307|NCT01808547|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
61308|NCT01808547|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
61309|NCT01808547|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
61310|NCT01808547|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
61311|NCT01808547|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
61312|NCT01808547|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
61313|NCT01808547|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
61314|NCT01808534|B1|Baseline|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61315|NCT01808534|P1|Participant Flow|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61316|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61317|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61318|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61319|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61320|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61321|NCT01808534|E1|Reported Event|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
61322|NCT01808508|B4|Baseline|Total|Total of all reporting groups
61323|NCT01808508|B3|Baseline|Group 3 - No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group
61324|NCT01808508|B2|Baseline|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61325|NCT01808508|B1|Baseline|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61326|NCT01808508|P3|Participant Flow|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61327|NCT01808508|P2|Participant Flow|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61328|NCT01808508|P1|Participant Flow|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61329|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61330|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61331|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61332|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61333|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61334|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61335|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61336|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61337|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61338|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61339|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61340|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61341|NCT01808508|E3|Reported Event|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
61342|NCT01808508|E2|Reported Event|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
61343|NCT01808508|E1|Reported Event|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
61344|NCT01808313|B1|Baseline|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61345|NCT01808313|P1|Participant Flow|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61346|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61347|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61348|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61349|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61350|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61351|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61352|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61353|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61354|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61355|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61356|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61357|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
105629|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
61358|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61359|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61360|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61361|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61362|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61363|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61364|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61365|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61366|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61367|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61368|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61369|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61370|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61371|NCT01808313|E1|Reported Event|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
61372|NCT01808248|B3|Baseline|Total|Total of all reporting groups
61373|NCT01808248|B2|Baseline|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
61374|NCT01808248|B1|Baseline|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection.
61375|NCT01808248|P1|Participant Flow|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
61376|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
61377|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
61378|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
61379|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
61380|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
61381|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
61382|NCT01808248|O1|Outcome|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
61383|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
105630|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
61384|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
61385|NCT01808248|E1|Reported Event|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
61386|NCT01808209|B3|Baseline|Total|Total of all reporting groups
61387|NCT01808209|B2|Baseline|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61388|NCT01808209|B1|Baseline|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61389|NCT01808209|P2|Participant Flow|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
61390|NCT01808209|P1|Participant Flow|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61391|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61392|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61393|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
61394|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61395|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
61396|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61397|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61398|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
61399|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61400|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61401|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
61402|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61403|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61404|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61405|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61406|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61407|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
61408|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61409|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61410|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
61411|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61412|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61413|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61414|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61415|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61416|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61417|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61418|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61419|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61420|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
61421|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61422|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61423|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
61424|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61425|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61426|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61427|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
61428|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
61429|NCT01808209|E2|Reported Event|Filcon II 3|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
61430|NCT01808209|E1|Reported Event|Stenfilcon A|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
61431|NCT01808092|B3|Baseline|Total|Total of all reporting groups
61432|NCT01808092|B2|Baseline|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61433|NCT01808092|B1|Baseline|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61434|NCT01808092|P2|Participant Flow|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61435|NCT01808092|P1|Participant Flow|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61436|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61437|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61438|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
63314|NCT01789775|E1|Reported Event|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
61439|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61440|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61441|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61442|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61443|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61444|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61445|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61446|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61447|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61448|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61449|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61450|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61451|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61452|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61453|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61454|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61455|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61456|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61457|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61458|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61459|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61460|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61461|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61462|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61463|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61464|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61465|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61466|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61467|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61468|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61469|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61470|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61471|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61472|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61473|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61474|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61475|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61476|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61477|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61478|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61479|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61480|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61481|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61482|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61483|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61484|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61485|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61486|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61487|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61488|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61489|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61490|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61491|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61492|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61493|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61494|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61495|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61496|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61497|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61498|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61499|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61500|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61501|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61502|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61503|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61504|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61505|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61506|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61507|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61508|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61509|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61510|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61511|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61512|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61513|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61514|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61515|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61516|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61517|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61518|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61519|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61520|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61521|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61522|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61523|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61524|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61525|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61526|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61527|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61528|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61529|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61530|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61531|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61532|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61533|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61534|NCT01808092|E2|Reported Event|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
61535|NCT01808092|E1|Reported Event|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
61536|NCT01808066|B1|Baseline|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
61537|NCT01808066|P1|Participant Flow|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
63605|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
61538|NCT01808066|O1|Outcome|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
61539|NCT01808066|E1|Reported Event|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
61540|NCT01807949|B4|Baseline|Total|Total of all reporting groups
61541|NCT01807949|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61542|NCT01807949|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61543|NCT01807949|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61544|NCT01807949|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61545|NCT01807949|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61546|NCT01807949|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
61547|NCT01807949|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61548|NCT01807949|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61549|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61550|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61551|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61552|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61553|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61554|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61555|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61556|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61557|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61558|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61559|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61560|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61561|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61562|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61563|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61564|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61565|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61566|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61567|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61568|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61569|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61570|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61571|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61572|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61573|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61574|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61575|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61576|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61577|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61578|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61579|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61580|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61581|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61582|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61583|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61584|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61585|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61586|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61587|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61588|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61589|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61590|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61591|NCT01807949|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61592|NCT01807949|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61593|NCT01807949|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61594|NCT01807923|B4|Baseline|Total|Total of all reporting groups
61595|NCT01807923|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61596|NCT01807923|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61597|NCT01807923|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61598|NCT01807923|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61599|NCT01807923|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61600|NCT01807923|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
61601|NCT01807923|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61602|NCT01807923|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61603|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61604|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61605|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61606|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61607|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61608|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61609|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61610|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61611|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61612|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61613|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61614|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61615|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61616|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61617|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61618|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61619|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61620|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61621|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61622|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61623|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61624|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61625|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61626|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61627|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61628|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61630|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61631|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61632|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61633|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61634|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61635|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61636|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61637|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61638|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61639|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61640|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61641|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61642|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61643|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61644|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61645|NCT01807923|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
61646|NCT01807923|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
61647|NCT01807923|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
61648|NCT01807624|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61649|NCT01807624|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61650|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61651|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61652|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61653|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61654|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61655|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61656|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61657|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61658|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61659|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61660|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61661|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61662|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
105631|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
61663|NCT01807624|E1|Reported Event|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
61664|NCT01807455|B1|Baseline|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61665|NCT01807455|P1|Participant Flow|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61666|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61667|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61668|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61669|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61670|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61671|NCT01807455|E1|Reported Event|Restylane Vital Lidocaine|Restylane Vital Lidocaine
61672|NCT01807156|B1|Baseline|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
61673|NCT01807156|P1|Participant Flow|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
61674|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
61675|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
61676|NCT01807156|E1|Reported Event|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
61677|NCT01807000|B1|Baseline|[14C] PRUCALOPRIDE SUCCINATE|
61678|NCT01807000|P1|Participant Flow|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61679|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61680|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61681|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61682|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61683|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61684|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61685|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61686|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61687|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61688|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61689|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61690|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61691|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61692|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61693|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61694|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61695|NCT01807000|E1|Reported Event|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
61696|NCT01806961|B1|Baseline|Clearance at End of Trial SP848-AK-1101|no trial medication during this follow-up trial
61697|NCT01806961|P1|Participant Flow|SP848-AK-1101|Patients from SP848-AK-1101 trial
61698|NCT01806961|O1|Outcome|Group 1|Patients from SP848-AK-1101 trial
61699|NCT01806961|E1|Reported Event|Group 1|Patients from SP848-AK-1101 trial
61700|NCT01806779|B3|Baseline|Total|Total of all reporting groups
61739|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61701|NCT01806779|B2|Baseline|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61702|NCT01806779|B1|Baseline|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61703|NCT01806779|P3|Participant Flow|Nicotine Patches Only|These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
61704|NCT01806779|P2|Participant Flow|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61705|NCT01806779|P1|Participant Flow|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61706|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61707|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61708|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61709|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61710|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61711|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61740|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61811|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
63606|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
61712|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61713|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61714|NCT01806779|E3|Reported Event|Nicotine Patch|All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
61715|NCT01806779|E2|Reported Event|Chantix + Zyban|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61716|NCT01806779|E1|Reported Event|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
61717|NCT01806623|B1|Baseline|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61718|NCT01806623|P1|Participant Flow|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61719|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61720|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61721|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61722|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61723|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61724|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61725|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61726|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61727|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61728|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61729|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61730|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61731|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61732|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61733|NCT01806623|E1|Reported Event|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
61734|NCT01806584|B3|Baseline|Total|Total of all reporting groups
61735|NCT01806584|B2|Baseline|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61736|NCT01806584|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61737|NCT01806584|P2|Participant Flow|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61738|NCT01806584|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61759|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61741|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61742|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61743|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61744|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61745|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61746|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61747|NCT01806584|E2|Reported Event|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
61748|NCT01806584|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
61749|NCT01806545|B3|Baseline|Total|Total of all reporting groups
61750|NCT01806545|B2|Baseline|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61751|NCT01806545|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61752|NCT01806545|P2|Participant Flow|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61753|NCT01806545|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61754|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61755|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61756|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61757|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61758|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61848|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
63607|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
61760|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61761|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61762|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61763|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61764|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61765|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61766|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61767|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61768|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61769|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61770|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61771|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61772|NCT01806545|E2|Reported Event|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61773|NCT01806545|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
61774|NCT01806051|B1|Baseline|All Participants|
61775|NCT01806051|P1|Participant Flow|All Participants|Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
61776|NCT01806051|O2|Outcome|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
61777|NCT01806051|O1|Outcome|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
61778|NCT01806051|E2|Reported Event|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
61913|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
61914|NCT01804062|E1|Reported Event|no Treatment|no treatment, prospective observational
61779|NCT01806051|E1|Reported Event|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
61780|NCT01805687|B1|Baseline|Zileuton Extended Release|Zileuton extended release
61781|NCT01805687|P1|Participant Flow|Zileuton Extended Release|Zileuton extended release 1200 mg (2 x 600 mg tablets)
61782|NCT01805687|O1|Outcome|Zileuton Extended Release|Zileuton extended release
61783|NCT01805687|E1|Reported Event|Zileuton Extended Release|Zileuton extended release
61784|NCT01805323|B1|Baseline|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
61785|NCT01805323|P1|Participant Flow|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
61786|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
61787|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
61788|NCT01805323|E1|Reported Event|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
61789|NCT01805180|B3|Baseline|Total|Total of all reporting groups
61790|NCT01805180|B2|Baseline|Arm 2|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61791|NCT01805180|B1|Baseline|Arm 1|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61792|NCT01805180|P3|Participant Flow|Arm 2 - COBE Spectra Followed by Spectra Optia PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
61793|NCT01805180|P2|Participant Flow|Arm 1 - Spectra Optia Followed by COBE Spectra PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
61794|NCT01805180|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
61795|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
61796|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. Device deficiency was not reported by randomization treatment arms.
61797|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61798|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61799|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61800|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61801|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61802|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61803|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
61804|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61805|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61806|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61807|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61808|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61809|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61810|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61915|NCT01803737|B3|Baseline|Total|Total of all reporting groups
61812|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
61813|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
61814|NCT01805180|E2|Reported Event|COBE Spectra|A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
61815|NCT01805180|E1|Reported Event|Spectra Optia|A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
61816|NCT01805089|B3|Baseline|Total|Total of all reporting groups
61817|NCT01805089|B2|Baseline|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61818|NCT01805089|B1|Baseline|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61819|NCT01805089|P2|Participant Flow|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61820|NCT01805089|P1|Participant Flow|Melatonin 3mg|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61821|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61822|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61823|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61824|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61825|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61826|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61827|NCT01805089|E2|Reported Event|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
61828|NCT01805089|E1|Reported Event|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
61829|NCT01804946|B3|Baseline|Total|Total of all reporting groups
61830|NCT01804946|B2|Baseline|Oseltamivir Group (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
61831|NCT01804946|B1|Baseline|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
61832|NCT01804946|P2|Participant Flow|Oseltamivir Group (OG)|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61833|NCT01804946|P1|Participant Flow|Ergoferon Group (EG)|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61834|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61835|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61836|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61837|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61838|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61839|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61840|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61841|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61842|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61843|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61844|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61845|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61846|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61847|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
63608|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
61849|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61850|NCT01804946|O2|Outcome|Oseltamivir Goup (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
61851|NCT01804946|O1|Outcome|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
61852|NCT01804946|E2|Reported Event|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
61853|NCT01804946|E1|Reported Event|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
61854|NCT01804881|B3|Baseline|Total|Total of all reporting groups
61855|NCT01804881|B2|Baseline|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
61856|NCT01804881|B1|Baseline|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61857|NCT01804881|P2|Participant Flow|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
61858|NCT01804881|P1|Participant Flow|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61859|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
61860|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61861|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
61862|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61863|NCT01804881|O2|Outcome|Wait List Control|wait list, offered craving change program at end of study
61864|NCT01804881|O1|Outcome|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61865|NCT01804881|E2|Reported Event|Wait List Control|wait list, offered craving change program at end of study
61866|NCT01804881|E1|Reported Event|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
61867|NCT01804842|B4|Baseline|Total|Total of all reporting groups
61868|NCT01804842|B3|Baseline|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61869|NCT01804842|B2|Baseline|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61870|NCT01804842|B1|Baseline|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61871|NCT01804842|P3|Participant Flow|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61872|NCT01804842|P2|Participant Flow|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61873|NCT01804842|P1|Participant Flow|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
61874|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
61875|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
61876|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
61877|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
61878|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
61879|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
61880|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
61881|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
61882|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
61883|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
61884|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
61885|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
61886|NCT01804842|E3|Reported Event|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
61887|NCT01804842|E2|Reported Event|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
61888|NCT01804842|E1|Reported Event|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
61889|NCT01804673|B1|Baseline|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
62001|NCT01802151|B2|Baseline|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
61890|NCT01804673|P1|Participant Flow|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61891|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61892|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61893|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61894|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61895|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61896|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61897|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61898|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61899|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61900|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61901|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61902|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61903|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61904|NCT01804673|E1|Reported Event|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
61905|NCT01804140|B1|Baseline|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
61906|NCT01804140|P1|Participant Flow|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
61907|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
61908|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
61909|NCT01804140|E1|Reported Event|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
61910|NCT01804062|B1|Baseline|no Treatment|no treatment, prospective observational
61911|NCT01804062|P1|Participant Flow|no Treatment|no treatment, prospective observational
61912|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
61916|NCT01803737|B2|Baseline|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61917|NCT01803737|B1|Baseline|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61918|NCT01803737|P2|Participant Flow|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61919|NCT01803737|P1|Participant Flow|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61920|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61921|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61922|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61923|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61924|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61925|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61926|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61927|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61928|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61929|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61930|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61931|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61932|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61933|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61934|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61935|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
62102|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
61936|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61937|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61938|NCT01803737|E2|Reported Event|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
61939|NCT01803737|E1|Reported Event|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
61940|NCT01802632|B7|Baseline|Total|Total of all reporting groups
61941|NCT01802632|B6|Baseline|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
61942|NCT01802632|B5|Baseline|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
61943|NCT01802632|B4|Baseline|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
61944|NCT01802632|B3|Baseline|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
61945|NCT01802632|B2|Baseline|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
61946|NCT01802632|B1|Baseline|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
61947|NCT01802632|P6|Participant Flow|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
61948|NCT01802632|P5|Participant Flow|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
61949|NCT01802632|P4|Participant Flow|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
61950|NCT01802632|P3|Participant Flow|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
61951|NCT01802632|P2|Participant Flow|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
61952|NCT01802632|P1|Participant Flow|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
61953|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
61954|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
61955|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
61956|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
61957|NCT01802632|O1|Outcome|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
61958|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
61959|NCT01802632|E6|Reported Event|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
61960|NCT01802632|E5|Reported Event|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
61961|NCT01802632|E4|Reported Event|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
61962|NCT01802632|E3|Reported Event|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
61963|NCT01802632|E2|Reported Event|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
61964|NCT01802632|E1|Reported Event|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
61965|NCT01802554|B3|Baseline|Total|Total of all reporting groups
61966|NCT01802554|B2|Baseline|Information Support (IS)|Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
61967|NCT01802554|B1|Baseline|Pleasant Events Program (PEP)|The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
61997|NCT01802515|E1|Reported Event|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
61998|NCT01802151|B5|Baseline|Total|Total of all reporting groups
61968|NCT01802554|P2|Participant Flow|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP) : Behavioral Activation Therapy"
61969|NCT01802554|P1|Participant Flow|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS) : Supportive Psychotherapy and informational brochures"
61970|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61971|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61972|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61973|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61974|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61975|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61976|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61977|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61999|NCT01802151|B4|Baseline|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62000|NCT01802151|B3|Baseline|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
105632|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
61978|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61979|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61980|NCT01802554|E2|Reported Event|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
61981|NCT01802554|E1|Reported Event|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
61982|NCT01802515|B4|Baseline|Total|Total of all reporting groups
61983|NCT01802515|B3|Baseline|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
61984|NCT01802515|B2|Baseline|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
61985|NCT01802515|B1|Baseline|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
61986|NCT01802515|P3|Participant Flow|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
61987|NCT01802515|P2|Participant Flow|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
61988|NCT01802515|P1|Participant Flow|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
61989|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
61990|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
61991|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
61992|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
61993|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
61994|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
61995|NCT01802515|E3|Reported Event|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
61996|NCT01802515|E2|Reported Event|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
63609|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
62002|NCT01802151|B1|Baseline|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62003|NCT01802151|P4|Participant Flow|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62004|NCT01802151|P3|Participant Flow|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62005|NCT01802151|P2|Participant Flow|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62006|NCT01802151|P1|Participant Flow|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62007|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62008|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62009|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62010|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62011|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62012|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62013|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62014|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62015|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62016|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62017|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62018|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62019|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62020|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62021|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62022|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62023|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62024|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62025|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62026|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62027|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62028|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62029|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62030|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62031|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62032|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62033|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62034|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62035|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62036|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62037|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62038|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62039|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62040|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62041|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62042|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62043|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62044|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62045|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62046|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62047|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62048|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62049|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62050|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62051|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62052|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62053|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62054|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62055|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62056|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62057|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62058|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62059|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62060|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62061|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62062|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62063|NCT01802151|E4|Reported Event|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62064|NCT01802151|E3|Reported Event|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62065|NCT01802151|E2|Reported Event|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
62066|NCT01802151|E1|Reported Event|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
62067|NCT01801982|B1|Baseline|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62068|NCT01801982|P1|Participant Flow|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62069|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62070|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62071|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62072|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62073|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62074|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62075|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62076|NCT01801982|E1|Reported Event|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
62077|NCT01801735|B1|Baseline|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
62078|NCT01801735|P1|Participant Flow|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
62079|NCT01801735|O1|Outcome|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
62080|NCT01801735|E1|Reported Event|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
62081|NCT01801475|B4|Baseline|Total|Total of all reporting groups
62082|NCT01801475|B3|Baseline|Neonates|"Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this Aim 1 of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours."
62083|NCT01801475|B2|Baseline|Non-pregnant Women|"Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.~Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
62084|NCT01801475|B1|Baseline|Pregnant Women|"Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.~Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
62085|NCT01801475|P5|Participant Flow|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
62086|NCT01801475|P4|Participant Flow|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
62087|NCT01801475|P3|Participant Flow|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
62088|NCT01801475|P2|Participant Flow|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
62089|NCT01801475|P1|Participant Flow|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
62090|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
62091|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
62092|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
62093|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
62094|NCT01801475|E5|Reported Event|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
62095|NCT01801475|E4|Reported Event|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
62096|NCT01801475|E3|Reported Event|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
62097|NCT01801475|E2|Reported Event|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
62098|NCT01801475|E1|Reported Event|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
62099|NCT01801436|B1|Baseline|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62100|NCT01801436|P1|Participant Flow|Bortezomib|Participants received 1.3 milligram per meter square (mg per m^2) of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62101|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62103|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62104|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62105|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62106|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62107|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62108|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62109|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62110|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62111|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62112|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62113|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62114|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62115|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62116|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62117|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62118|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62119|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62120|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62121|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62122|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62123|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62124|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62125|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62126|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62127|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62128|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62129|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62130|NCT01801436|E1|Reported Event|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
62131|NCT01801358|B7|Baseline|Total|Total of all reporting groups
62132|NCT01801358|B6|Baseline|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62133|NCT01801358|B5|Baseline|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62134|NCT01801358|B4|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62135|NCT01801358|B3|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62136|NCT01801358|B2|Baseline|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62137|NCT01801358|B1|Baseline|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62138|NCT01801358|P6|Participant Flow|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62139|NCT01801358|P5|Participant Flow|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62140|NCT01801358|P4|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62141|NCT01801358|P3|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62142|NCT01801358|P2|Participant Flow|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62143|NCT01801358|P1|Participant Flow|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62144|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62145|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62146|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62147|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62148|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62149|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62150|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62151|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62152|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62153|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62154|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62155|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62156|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62157|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62158|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62159|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62160|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62161|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62162|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62163|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62164|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62165|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62166|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62167|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62168|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62169|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62170|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62171|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62172|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62173|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62174|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62175|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62176|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62177|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62178|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62681|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62179|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62180|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62181|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62182|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62183|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62184|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62185|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62186|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62187|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62188|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62189|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62190|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62191|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62192|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62193|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62194|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62195|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62196|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62197|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62198|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62199|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62200|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62201|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62202|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62203|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62204|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62205|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62206|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62207|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62208|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62209|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62210|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62211|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62212|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62213|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62682|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62214|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62215|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62216|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62217|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62218|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62219|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62220|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62221|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62222|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62223|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62224|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62225|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62226|NCT01801358|O1|Outcome|Phase Ib (Dose Escalation)|"For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62227|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62228|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62229|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62230|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62231|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62232|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62233|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62234|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62235|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62236|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62237|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62238|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62239|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62240|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62241|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62242|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62243|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62244|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
105633|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
62245|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62246|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62247|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
62248|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62249|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62250|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62251|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62252|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62253|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62254|NCT01801358|E6|Reported Event|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62255|NCT01801358|E5|Reported Event|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62256|NCT01801358|E4|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62257|NCT01801358|E3|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62258|NCT01801358|E2|Reported Event|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62259|NCT01801358|E1|Reported Event|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
62260|NCT01801280|B5|Baseline|Total|Total of all reporting groups
62261|NCT01801280|B4|Baseline|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
62262|NCT01801280|B3|Baseline|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
62263|NCT01801280|B2|Baseline|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
62264|NCT01801280|B1|Baseline|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
62265|NCT01801280|P4|Participant Flow|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
62266|NCT01801280|P3|Participant Flow|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
62267|NCT01801280|P2|Participant Flow|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
62299|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62349|NCT01800968|E1|Reported Event|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.~Liraglutide: Active Drug"
62268|NCT01801280|P1|Participant Flow|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
62269|NCT01801280|O4|Outcome|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
62270|NCT01801280|O3|Outcome|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
62271|NCT01801280|O2|Outcome|MMF+PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
62272|NCT01801280|O1|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
62273|NCT01801280|E4|Reported Event|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
62274|NCT01801280|E3|Reported Event|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
62275|NCT01801280|E2|Reported Event|MMF + PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
62276|NCT01801280|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
62277|NCT01801124|B1|Baseline|EXPAREL|undiluted EXPAREL 266 mg
62278|NCT01801124|P1|Participant Flow|EXPAREL|undiluted EXPAREL 266 mg
62279|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
62280|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
62281|NCT01801124|E1|Reported Event|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
62282|NCT01801111|B1|Baseline|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62283|NCT01801111|P1|Participant Flow|Alectinib|Participants received alectinib 600 milligrams (mg), capsule, orally, twice daily (BID), continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62284|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62285|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62286|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62287|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62288|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62289|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62290|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62291|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62292|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62293|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62294|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62295|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62296|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62297|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62298|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62431|NCT01799720|B3|Baseline|Only Diet|Participants from group 3 only received the diet. Follow-up 30 days.
62300|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62301|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62302|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62303|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62304|NCT01801111|E1|Reported Event|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
62305|NCT01800968|B3|Baseline|Total|Total of all reporting groups
62306|NCT01800968|B2|Baseline|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62307|NCT01800968|B1|Baseline|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62308|NCT01800968|P2|Participant Flow|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62309|NCT01800968|P1|Participant Flow|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62310|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62311|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62312|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62313|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62314|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62315|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62316|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62317|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62318|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62319|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62320|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62321|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62322|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62323|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62324|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62325|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62326|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62327|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62328|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62329|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62330|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62331|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62332|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62333|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62334|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62335|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62336|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62337|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62338|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62339|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62340|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62341|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62342|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62343|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62344|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62345|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62346|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
62347|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
62348|NCT01800968|E2|Reported Event|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.~Placebo: Placebo"
62350|NCT01800916|B1|Baseline|Overall Study Population|Baseline data was obtained on all subjects in the ITT population. Two subjects were not included in the ITT population as they were screen failures. One screen failure was discovered before randomization (this subjects is not found in the Participant flow), the other subject was randomized before it was discovered that the subjects was a screen failure and is therefore included in the randomized popultion but not in the ITT population as the participant did not test a product.
62351|NCT01800916|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
62352|NCT01800916|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
62353|NCT01800916|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
62354|NCT01800916|P6|Participant Flow|Test C/SenSura/Test A|The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
62355|NCT01800916|P5|Participant Flow|Test C/Test B/SenSura|The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
62356|NCT01800916|P4|Participant Flow|Test B/SenSura/Test C|The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
62357|NCT01800916|P3|Participant Flow|Test B/SenSura/Test A|The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
62358|NCT01800916|P2|Participant Flow|Test A/Test C/SenSura|The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
62359|NCT01800916|P1|Participant Flow|Test A/Test B/SenSura|The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
62360|NCT01800916|O4|Outcome|SenSura|
62361|NCT01800916|O3|Outcome|Test C|
62362|NCT01800916|O2|Outcome|Test B|
62363|NCT01800916|O1|Outcome|Test A|
62364|NCT01800916|E4|Reported Event|SenSura|
62365|NCT01800916|E3|Reported Event|Test C|
62366|NCT01800916|E2|Reported Event|Test B|
62367|NCT01800916|E1|Reported Event|Test A|
62368|NCT01800903|B1|Baseline|All Participants|The intention to treat population consists of 36 healthy male subjects
62369|NCT01800903|P6|Participant Flow|ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter|First ZN-C catheter then ZN-D catheter then SpeediCath catheter
62370|NCT01800903|P5|Participant Flow|ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter|First ZN-C catheter then SpeediCath catheter then ZN-D catheter
62371|NCT01800903|P4|Participant Flow|ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter|First ZN-D catheter then ZN-C catheter then SpeediCath catheter
62372|NCT01800903|P3|Participant Flow|ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter|First ZN-D catheter then SpeediCath catheter then ZN-C catheter
62373|NCT01800903|P2|Participant Flow|SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter|First SpeediCath catheter then ZN-C catheter then ZN-D catheter
62374|NCT01800903|P1|Participant Flow|SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter|First SpeediCath catheter then ZN-D catheter then ZN-C catheter
62375|NCT01800903|O3|Outcome|SpeediCath|Subjects who tested the Speedicath catheter
62376|NCT01800903|O2|Outcome|ZN-C Catheter|Subjects who tested the ZN-C catheter
62377|NCT01800903|O1|Outcome|ZN-D Catheter|Subjects who tested the ZN-D catheter
62378|NCT01800903|E1|Reported Event|All Participants|"Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.~However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module."
62379|NCT01800890|B1|Baseline|Overall Study Population|baseline data is given for subjects in the ITT population
62380|NCT01800890|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
62381|NCT01800890|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
62382|NCT01800890|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
62383|NCT01800890|P6|Participant Flow|Test C/ SenSura/ Test A|The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
62384|NCT01800890|P5|Participant Flow|Test C/ Test B/ SenSura|The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
62385|NCT01800890|P4|Participant Flow|Test B/ SenSura/ Test C|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
62386|NCT01800890|P3|Participant Flow|Test B/ SenSura/ Test A|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
62387|NCT01800890|P2|Participant Flow|Test A/ Test C/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
62388|NCT01800890|P1|Participant Flow|Test A/ Test B/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
62389|NCT01800890|O4|Outcome|SenSura|The comparator
62390|NCT01800890|O3|Outcome|Coloplast Test Product C|new test product
62391|NCT01800890|O2|Outcome|Coloplast Test Product B|new test product
62392|NCT01800890|O1|Outcome|Coloplast Test Product A|new test product
62393|NCT01800890|E4|Reported Event|SenSura|The comparator was the CE-marked product SenSura Click
62394|NCT01800890|E3|Reported Event|Coloplast Test Product C|Coloplast Test product C is a new test product
62395|NCT01800890|E2|Reported Event|Coloplast Test Product B|Coloplast Test product B is a new test product
62396|NCT01800890|E1|Reported Event|Coloplast Test Product A|Coloplast Test product A is a new test product
62397|NCT01800318|B5|Baseline|Total|Total of all reporting groups
62683|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62398|NCT01800318|B4|Baseline|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62399|NCT01800318|B3|Baseline|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62400|NCT01800318|B2|Baseline|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62401|NCT01800318|B1|Baseline|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62402|NCT01800318|P4|Participant Flow|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62403|NCT01800318|P3|Participant Flow|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62404|NCT01800318|P2|Participant Flow|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62405|NCT01800318|P1|Participant Flow|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
105634|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
62406|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62407|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
62408|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62409|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62410|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62411|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
62412|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62413|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62432|NCT01799720|B2|Baseline|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62414|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62415|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62416|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62417|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62418|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62419|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62420|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62421|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62532|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
62422|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62423|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62424|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62425|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62426|NCT01800318|E4|Reported Event|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
62427|NCT01800318|E3|Reported Event|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
62428|NCT01800318|E2|Reported Event|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
62429|NCT01800318|E1|Reported Event|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
62430|NCT01799720|B4|Baseline|Total|Total of all reporting groups
62433|NCT01799720|B1|Baseline|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62434|NCT01799720|P3|Participant Flow|Diet|Participants from group 3 took only diet, Follow-up 30 days
62435|NCT01799720|P2|Participant Flow|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
62436|NCT01799720|P1|Participant Flow|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
62437|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62438|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62439|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62440|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62441|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62442|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62443|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62444|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62445|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62446|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62447|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62448|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62449|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62450|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62451|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62452|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62453|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62454|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62455|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62456|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62457|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62458|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62459|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62460|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62461|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62462|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62463|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62464|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62465|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62466|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62467|NCT01799720|E3|Reported Event|Diet|Participants from group 3 only took diet. Follow-up 30 days.
62468|NCT01799720|E2|Reported Event|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62469|NCT01799720|E1|Reported Event|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
62470|NCT01799590|B4|Baseline|Total|Total of all reporting groups
62471|NCT01799590|B3|Baseline|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62533|NCT01798966|E1|Reported Event|SENSIMED Triggerfish|All patients included in the device group
62684|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62472|NCT01799590|B2|Baseline|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62473|NCT01799590|B1|Baseline|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62474|NCT01799590|P3|Participant Flow|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62475|NCT01799590|P2|Participant Flow|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62476|NCT01799590|P1|Participant Flow|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62477|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62478|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62479|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62480|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62481|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62482|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62483|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62484|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62485|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62486|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62487|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62488|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62489|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62676|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62490|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62491|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62492|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62493|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62494|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62495|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62496|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62497|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62498|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62499|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62500|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62501|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62502|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62503|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62504|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62505|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62506|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62507|NCT01799590|E3|Reported Event|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62677|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62508|NCT01799590|E2|Reported Event|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62509|NCT01799590|E1|Reported Event|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
62510|NCT01799239|B1|Baseline|Overall Study|Describing baseline data for all subjects in the ITT population
62511|NCT01799239|P2|Participant Flow|First SenSura, Then Test Product|The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
62512|NCT01799239|P1|Participant Flow|First Test Product; Then SenSura|The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
62513|NCT01799239|O2|Outcome|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
62514|NCT01799239|O1|Outcome|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
62515|NCT01799239|E2|Reported Event|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
62516|NCT01799239|E1|Reported Event|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
62517|NCT01799226|B3|Baseline|Total|Total of all reporting groups
62518|NCT01799226|B2|Baseline|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
62519|NCT01799226|B1|Baseline|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
62520|NCT01799226|P2|Participant Flow|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
62521|NCT01799226|P1|Participant Flow|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
62522|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
62523|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
62524|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
62525|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
62526|NCT01799226|E2|Reported Event|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
62527|NCT01799226|E1|Reported Event|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
62528|NCT01798966|B1|Baseline|SENSIMED Triggerfish|All patients included in the device group
62529|NCT01798966|P1|Participant Flow|SENSIMED Triggerfish|All patients included in the device group
62530|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
62531|NCT01798966|O1|Outcome|SENSIMED Triggerfish|All patients included in the device group
62534|NCT01798927|B1|Baseline|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62535|NCT01798927|P1|Participant Flow|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62536|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62537|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62538|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62539|NCT01798927|E1|Reported Event|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
62540|NCT01798706|B3|Baseline|Total|Total of all reporting groups
62541|NCT01798706|B2|Baseline|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62542|NCT01798706|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62543|NCT01798706|P2|Participant Flow|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62544|NCT01798706|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62545|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62546|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62547|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62548|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62549|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62550|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62551|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62552|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62553|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62554|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62555|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62556|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62557|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62558|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62559|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62560|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62561|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62562|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62563|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62564|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62565|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
62566|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
62567|NCT01798706|E2|Reported Event|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
62678|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62850|NCT01796964|B3|Baseline|Total|Total of all reporting groups
62568|NCT01798706|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)
62569|NCT01798485|B3|Baseline|Total|Total of all reporting groups
62570|NCT01798485|B2|Baseline|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62571|NCT01798485|B1|Baseline|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62572|NCT01798485|P2|Participant Flow|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62573|NCT01798485|P1|Participant Flow|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62574|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62575|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62576|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62577|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62578|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62579|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62580|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62581|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62582|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62583|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62584|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62585|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62586|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62587|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62588|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62589|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62590|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62591|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62592|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62593|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62594|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62595|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62596|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62597|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62598|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62679|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62599|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62600|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62601|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62602|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62603|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62604|NCT01798485|E2|Reported Event|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
62605|NCT01798485|E1|Reported Event|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
62606|NCT01798394|B3|Baseline|Total|Total of all reporting groups
62607|NCT01798394|B2|Baseline|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62608|NCT01798394|B1|Baseline|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62609|NCT01798394|P2|Participant Flow|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62610|NCT01798394|P1|Participant Flow|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62611|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62612|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62613|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62614|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62615|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62616|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62617|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62618|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62619|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62620|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62621|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62622|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62623|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62680|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62624|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62625|NCT01798394|E2|Reported Event|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
62626|NCT01798394|E1|Reported Event|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
62627|NCT01798264|B5|Baseline|Total|Total of all reporting groups
62628|NCT01798264|B4|Baseline|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62629|NCT01798264|B3|Baseline|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62630|NCT01798264|B2|Baseline|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62631|NCT01798264|B1|Baseline|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62632|NCT01798264|P4|Participant Flow|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62633|NCT01798264|P3|Participant Flow|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62634|NCT01798264|P2|Participant Flow|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62635|NCT01798264|P1|Participant Flow|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62636|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62637|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62638|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62639|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62640|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62641|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62642|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62643|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62644|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62645|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62646|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62647|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62648|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62649|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62650|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62651|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62652|NCT01798264|E4|Reported Event|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
62653|NCT01798264|E3|Reported Event|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
62654|NCT01798264|E2|Reported Event|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
62655|NCT01798264|E1|Reported Event|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
62656|NCT01798134|B1|Baseline|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62657|NCT01798134|P1|Participant Flow|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62658|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62659|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62660|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62661|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62662|NCT01798134|E1|Reported Event|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
62663|NCT01798004|B1|Baseline|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
62664|NCT01798004|P1|Participant Flow|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
62665|NCT01798004|O1|Outcome|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
62666|NCT01798004|E1|Reported Event|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
62667|NCT01797783|B3|Baseline|Total|Total of all reporting groups
62668|NCT01797783|B2|Baseline|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62669|NCT01797783|B1|Baseline|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62670|NCT01797783|P2|Participant Flow|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62671|NCT01797783|P1|Participant Flow|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62672|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62673|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62674|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62675|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
105635|NCT01568073|E5|Reported Event|OPC 50mg|OPC, Opicapone 50mg
62685|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62686|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62687|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62688|NCT01797783|O2|Outcome|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62689|NCT01797783|O1|Outcome|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62690|NCT01797783|E2|Reported Event|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
62691|NCT01797783|E1|Reported Event|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
62692|NCT01797705|B1|Baseline|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
62693|NCT01797705|P1|Participant Flow|All Subjects|All enrolled subjects
62694|NCT01797705|O1|Outcome|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
62695|NCT01797705|E1|Reported Event|Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
62696|NCT01797536|B5|Baseline|Total|Total of all reporting groups
62697|NCT01797536|B4|Baseline|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62698|NCT01797536|B3|Baseline|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62699|NCT01797536|B2|Baseline|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62700|NCT01797536|B1|Baseline|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62701|NCT01797536|P4|Participant Flow|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62702|NCT01797536|P3|Participant Flow|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62703|NCT01797536|P2|Participant Flow|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62704|NCT01797536|P1|Participant Flow|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62705|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62706|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62707|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62708|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62709|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62710|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62711|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62712|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62713|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62714|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62715|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62716|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62717|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62718|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62719|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62720|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62721|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62722|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62723|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62724|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62725|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62726|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62727|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62728|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62729|NCT01797536|E4|Reported Event|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
62730|NCT01797536|E3|Reported Event|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
62731|NCT01797536|E2|Reported Event|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
62732|NCT01797536|E1|Reported Event|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
62733|NCT01797445|B3|Baseline|Total|Total of all reporting groups
62734|NCT01797445|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62735|NCT01797445|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62736|NCT01797445|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62737|NCT01797445|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
62738|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62739|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62740|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62741|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62742|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62743|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62744|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62745|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62746|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62747|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62748|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62749|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62750|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62751|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62752|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62753|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62754|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62755|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62756|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
63769|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
62757|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62758|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62759|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62760|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62761|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62762|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62763|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62764|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62765|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62766|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62767|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62768|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62769|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62770|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62771|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62772|NCT01797445|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
62773|NCT01797445|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
62774|NCT01797380|B3|Baseline|Total|Total of all reporting groups
62775|NCT01797380|B2|Baseline|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
62776|NCT01797380|B1|Baseline|Sugar Pill|Placebo
62777|NCT01797380|P2|Participant Flow|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
62778|NCT01797380|P1|Participant Flow|Sugar Pill|Placebo
62779|NCT01797380|O2|Outcome|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
62780|NCT01797380|O1|Outcome|Sugar Pill|Placebo
62781|NCT01797380|E2|Reported Event|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
62782|NCT01797380|E1|Reported Event|Sugar Pill|Placebo
62783|NCT01797094|B3|Baseline|Total|Total of all reporting groups
62784|NCT01797094|B2|Baseline|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62785|NCT01797094|B1|Baseline|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62786|NCT01797094|P2|Participant Flow|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62787|NCT01797094|P1|Participant Flow|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62788|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62789|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62790|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62791|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62792|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62793|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62794|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62851|NCT01796964|B2|Baseline|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62795|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62796|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62797|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62798|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62799|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62800|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62801|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62802|NCT01797094|E2|Reported Event|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62803|NCT01797094|E1|Reported Event|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62804|NCT01797081|B5|Baseline|Total|Total of all reporting groups
62805|NCT01797081|B4|Baseline|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
62806|NCT01797081|B3|Baseline|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
62807|NCT01797081|B2|Baseline|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62808|NCT01797081|B1|Baseline|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62809|NCT01797081|P4|Participant Flow|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
62810|NCT01797081|P3|Participant Flow|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
62811|NCT01797081|P2|Participant Flow|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62812|NCT01797081|P1|Participant Flow|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62813|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
62814|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62815|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62816|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
62817|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62818|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62819|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
62820|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62821|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62822|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
62823|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62824|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62825|NCT01797081|E3|Reported Event|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
62826|NCT01797081|E2|Reported Event|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62827|NCT01797081|E1|Reported Event|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
62828|NCT01797029|B3|Baseline|Total|Total of all reporting groups
62829|NCT01797029|B2|Baseline|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
62830|NCT01797029|B1|Baseline|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
62831|NCT01797029|P2|Participant Flow|Placebo|Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (SIIL) LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
62832|NCT01797029|P1|Participant Flow|Vaccine|A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
62833|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
62834|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
62835|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
62836|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
62837|NCT01797029|E2|Reported Event|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
62838|NCT01797029|E1|Reported Event|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
62839|NCT01796977|B1|Baseline|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article)."
62840|NCT01796977|P1|Participant Flow|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control))."
62841|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
62842|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
62843|NCT01796977|O1|Outcome|All Available Study Participants|Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.
62844|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
62845|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
62846|NCT01796977|O2|Outcome|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
62847|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
62848|NCT01796977|E2|Reported Event|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
62849|NCT01796977|E1|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
62852|NCT01796964|B1|Baseline|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62853|NCT01796964|P2|Participant Flow|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62854|NCT01796964|P1|Participant Flow|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62855|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62856|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62857|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62858|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62859|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62860|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62861|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62862|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62863|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62864|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62865|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62866|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62867|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62868|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62869|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62870|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
62871|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
62872|NCT01796964|E3|Reported Event|EYLEA|All subjects who were randomized and received at least 1 IVT injection of Aflibercept
62873|NCT01796964|E2|Reported Event|ESBA 1008|All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution
62874|NCT01796964|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study
62875|NCT01796860|B1|Baseline|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62876|NCT01796860|P1|Participant Flow|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62877|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62878|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62879|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62880|NCT01796860|E1|Reported Event|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
62881|NCT01796548|B1|Baseline|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
62940|NCT01795937|E6|Reported Event|Faldaprevir + Atorvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment D.~From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date."
62882|NCT01796548|P1|Participant Flow|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62883|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62884|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62885|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62886|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62887|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62888|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62889|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62890|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62891|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62892|NCT01796548|E1|Reported Event|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
62893|NCT01796236|B3|Baseline|Total|Total of all reporting groups
62894|NCT01796236|B2|Baseline|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62895|NCT01796236|B1|Baseline|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62896|NCT01796236|P2|Participant Flow|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62897|NCT01796236|P1|Participant Flow|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62898|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
63315|NCT01790828|B1|Baseline|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
62899|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62900|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62901|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62902|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62903|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62904|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62905|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62906|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62907|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62908|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62909|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no softtissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments)."
62910|NCT01796236|E2|Reported Event|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
62911|NCT01796236|E1|Reported Event|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
62912|NCT01795937|B4|Baseline|Total|Total of all reporting groups
62913|NCT01795937|B3|Baseline|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
62914|NCT01795937|B2|Baseline|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
62941|NCT01795937|E5|Reported Event|Faldaprevir (Statins Part)|From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
63316|NCT01790828|P1|Participant Flow|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
62915|NCT01795937|B1|Baseline|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
62916|NCT01795937|P3|Participant Flow|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
62917|NCT01795937|P2|Participant Flow|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
62918|NCT01795937|P1|Participant Flow|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
62919|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
62920|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
62921|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
62922|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
62923|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
62924|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
62925|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
62926|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
62927|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
62928|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
62929|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
62930|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
62931|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
62932|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
62933|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
62934|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
62935|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
62936|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
62937|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
62938|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
62939|NCT01795937|E7|Reported Event|Faldaprevir + Rosuvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment F.~From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date."
62942|NCT01795937|E4|Reported Event|Rosuvastatin (Statins Part)|"Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment E.~From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date."
62943|NCT01795937|E3|Reported Event|Atorvastatin (Statins Part)|"Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment C.~From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject."
62944|NCT01795937|E2|Reported Event|Faldaprevir+Itraconazole (Itraconazole Part)|"Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.~Treatment B."
62945|NCT01795937|E1|Reported Event|Faldaprevir (Itraconazole Part)|"Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.~Treatment A."
62946|NCT01795898|B1|Baseline|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62947|NCT01795898|P1|Participant Flow|Fentanyl|Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62948|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62949|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62950|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62951|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62952|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62953|NCT01795898|E1|Reported Event|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
62954|NCT01795716|B3|Baseline|Total|Total of all reporting groups
62955|NCT01795716|B2|Baseline|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
62956|NCT01795716|B1|Baseline|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
62957|NCT01795716|P2|Participant Flow|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
62958|NCT01795716|P1|Participant Flow|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
62959|NCT01795716|O2|Outcome|Glivec|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
62960|NCT01795716|O1|Outcome|Mesylate Imatinib Capsule|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
62961|NCT01795716|E2|Reported Event|Glivec|Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
62962|NCT01795716|E1|Reported Event|Mesylate Imatinib Capsule|Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
62963|NCT01795547|B3|Baseline|Total|Total of all reporting groups
62964|NCT01795547|B2|Baseline|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62965|NCT01795547|B1|Baseline|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62966|NCT01795547|P2|Participant Flow|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62967|NCT01795547|P1|Participant Flow|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62968|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62992|NCT01795534|O1|Outcome|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
62969|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62970|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62971|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62972|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62973|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62974|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62975|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62976|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62977|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62978|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62979|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62980|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62981|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62982|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
62983|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
62984|NCT01795547|O2|Outcome|Paliperidone|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
62985|NCT01795547|O1|Outcome|Aripiprazole|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
62986|NCT01795547|E2|Reported Event|PALIPERIDONE|Safety data is based on all patients who received study medicine.
62987|NCT01795547|E1|Reported Event|ARIPIPRAZOLE|Safety data is based on all patients who received study medicine.
62988|NCT01795534|B1|Baseline|All Participants|Includes groups randomized to receive beetroot shot first and placebo first.
62989|NCT01795534|P2|Participant Flow|Placebo Shot Then Beetroot Shot|"Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)~Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
62990|NCT01795534|P1|Participant Flow|Beetroot Shot Then Placebo Shot|"Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).~Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)"
62991|NCT01795534|O2|Outcome|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
62993|NCT01795534|E2|Reported Event|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
62994|NCT01795534|E1|Reported Event|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
62995|NCT01794936|B1|Baseline|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
62996|NCT01794936|P1|Participant Flow|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
62997|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
62998|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
62999|NCT01794936|E1|Reported Event|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
63000|NCT01794741|B3|Baseline|Total|Total of all reporting groups
63001|NCT01794741|B2|Baseline|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
63002|NCT01794741|B1|Baseline|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
63003|NCT01794741|P2|Participant Flow|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
63004|NCT01794741|P1|Participant Flow|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
63005|NCT01794741|O2|Outcome|Fluticasone Nasal Spray|
63006|NCT01794741|O1|Outcome|Dymista Nasal Spray|
63007|NCT01794741|E2|Reported Event|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
63008|NCT01794741|E1|Reported Event|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
63009|NCT01794455|B3|Baseline|Total|Total of all reporting groups
63010|NCT01794455|B2|Baseline|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63011|NCT01794455|B1|Baseline|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63012|NCT01794455|P2|Participant Flow|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63013|NCT01794455|P1|Participant Flow|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63014|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63015|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63016|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63017|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63018|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63019|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63020|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63021|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63022|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63023|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63024|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63025|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63026|NCT01794455|E2|Reported Event|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
63027|NCT01794455|E1|Reported Event|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
63028|NCT01794000|B3|Baseline|Total|Total of all reporting groups
63029|NCT01794000|B2|Baseline|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63030|NCT01794000|B1|Baseline|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63031|NCT01794000|P2|Participant Flow|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63032|NCT01794000|P1|Participant Flow|Prasugrel|Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63033|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63034|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63035|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63036|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63037|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63038|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63039|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63040|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63041|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63042|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63043|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63044|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63045|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63046|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63047|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63048|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63049|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63050|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63051|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63052|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63540|NCT01788163|O10|Outcome|Thailand-Mutation Status Negative|Subjects in Thailand that meet I/E and population criteria, who had a Negative Mutation Status.
63053|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63054|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63055|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63056|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63057|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63058|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63059|NCT01794000|E3|Reported Event|Prasugrel - Open Label Phase|Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
63060|NCT01794000|E2|Reported Event|Placebo - Double Blind Phase|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
63061|NCT01794000|E1|Reported Event|Prasugrel - Double Blind Phase|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
63062|NCT01793285|B1|Baseline|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63063|NCT01793285|P1|Participant Flow|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63064|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63065|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63066|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63067|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63068|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63069|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63070|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63071|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63072|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63073|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63074|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63838|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63075|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63076|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63077|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63078|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63079|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63080|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63081|NCT01793285|E1|Reported Event|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
63082|NCT01792986|B1|Baseline|Water-only 24-hour Fasting|
63083|NCT01792986|P1|Participant Flow|Water-only 24-hour Fasting|water-only 24-hour fasting
63084|NCT01792986|O1|Outcome|Water-only 24-hour Fasting|
63085|NCT01792986|O1|Outcome|Water-only 24-hour Fasting|
63086|NCT01792986|O1|Outcome|Water-only 24-hour Fasting|
63087|NCT01792986|O1|Outcome|Water-only 24-hour Fasting|
63088|NCT01792986|O1|Outcome|Water-only 24-hour Fasting|
63089|NCT01792986|E1|Reported Event|Water-only 24-hour Fasting|
63090|NCT01792830|B8|Baseline|Total|Total of all reporting groups
63091|NCT01792830|B7|Baseline|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
63092|NCT01792830|B6|Baseline|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
63093|NCT01792830|B5|Baseline|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
63094|NCT01792830|B4|Baseline|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen.
63095|NCT01792830|B3|Baseline|No Diabetes/ Insulin|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin.
63096|NCT01792830|B2|Baseline|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
63097|NCT01792830|B1|Baseline|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
63098|NCT01792830|P7|Participant Flow|Diabetic/Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
63099|NCT01792830|P6|Participant Flow|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
63100|NCT01792830|P5|Participant Flow|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
63101|NCT01792830|P4|Participant Flow|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
63102|NCT01792830|P3|Participant Flow|No Diabetes Insulin Group|Patients with an HbA1c < 7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
63103|NCT01792830|P2|Participant Flow|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
63104|NCT01792830|P1|Participant Flow|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, were discharged from the hospital without any antidiabetic therapy.
63178|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
63105|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on glulisine, a rapid-acting insulin to be taken before meals.
63106|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + IInsulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% will be discharged on oral metformin and glargine insulin to be taken daily at the same time of day; or, basal bolus insulin regimen.
63107|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
63108|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission will be discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
63109|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin is given in divided doses with meals.
63110|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
63111|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.~Patients without a history of diabetes and admission HbA1C < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.~Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
63112|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
63113|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
63114|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.
63115|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on glulisine, a rapid-acting insulin taken before meals.
63116|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + Insulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% were discharged on oral metformin and glargine insulin taken daily at the same time of day; or, basal bolus insulin regimen.
63117|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy were discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
63118|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission were discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
63119|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin was given in divided doses with meals.
63120|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to glargine and identify the minimum effective dose for the patient. Glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels."
63121|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient."
63122|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
63123|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% were discharged on oral metformin.
63306|NCT01789775|B3|Baseline|Total|Total of all reporting groups
63307|NCT01789775|B2|Baseline|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
63124|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital were discharged on no antidiabetic therapy.
63125|NCT01792830|E6|Reported Event|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
63126|NCT01792830|E5|Reported Event|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
63127|NCT01792830|E4|Reported Event|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
63128|NCT01792830|E3|Reported Event|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
63129|NCT01792830|E2|Reported Event|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
63130|NCT01792830|E1|Reported Event|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
63131|NCT01792635|B4|Baseline|Total|Total of all reporting groups
63132|NCT01792635|B3|Baseline|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63133|NCT01792635|B2|Baseline|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63134|NCT01792635|B1|Baseline|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63135|NCT01792635|P3|Participant Flow|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63136|NCT01792635|P2|Participant Flow|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63137|NCT01792635|P1|Participant Flow|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63138|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63139|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63140|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63141|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63142|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63143|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63144|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63145|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63146|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63147|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63148|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63149|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63150|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63151|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63152|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63153|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63154|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63155|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63156|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63157|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63158|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63159|NCT01792635|E3|Reported Event|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63160|NCT01792635|E2|Reported Event|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
63161|NCT01792635|E1|Reported Event|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
63162|NCT01791972|B3|Baseline|Total|Total of all reporting groups
63163|NCT01791972|B2|Baseline|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
63164|NCT01791972|B1|Baseline|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
63165|NCT01791972|P2|Participant Flow|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
63166|NCT01791972|P1|Participant Flow|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
63167|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
63168|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
63169|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
63170|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
63171|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
63172|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
63173|NCT01791972|E2|Reported Event|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
63174|NCT01791972|E1|Reported Event|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
63175|NCT01791894|B1|Baseline|Treatment (Arsenic Trioxide)|arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
63176|NCT01791894|P1|Participant Flow|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
63177|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
63179|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
63180|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
63181|NCT01791894|E1|Reported Event|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV"
63182|NCT01791725|B4|Baseline|Total|Total of all reporting groups
63183|NCT01791725|B3|Baseline|Placebo|"Placebo BID~Placebo"
63184|NCT01791725|B2|Baseline|ELND005 QD|"ELND005 250 mg QD~ELND005"
63185|NCT01791725|B1|Baseline|ELND005 BID|"ELND005 250 mg BID~ELND005"
63186|NCT01791725|P3|Participant Flow|Placebo|"Placebo BID~Placebo"
63187|NCT01791725|P2|Participant Flow|ELND005 QD|"ELND005 250 mg QD~ELND005"
63188|NCT01791725|P1|Participant Flow|ELND005 BID|"ELND005 250 mg BID~ELND005"
63189|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
63190|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
63191|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
63192|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
63193|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
63194|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
63195|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
63196|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
63197|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
63198|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
63199|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
63200|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
63201|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
63202|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
63203|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
63204|NCT01791725|E3|Reported Event|Placebo|"Placebo BID~Placebo"
63205|NCT01791725|E2|Reported Event|ELND005 QD|"ELND005 250 mg QD~ELND005"
63206|NCT01791725|E1|Reported Event|ELND005 BID|"ELND005 250 mg BID~ELND005"
63207|NCT01791413|B3|Baseline|Total|Total of all reporting groups
63208|NCT01791413|B2|Baseline|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
63209|NCT01791413|B1|Baseline|No Depot Medroxyprogesterone Acetate|
63210|NCT01791413|P2|Participant Flow|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
63211|NCT01791413|P1|Participant Flow|No Depot Medroxyprogesterone Acetate|
63212|NCT01791413|O4|Outcome|3 mo. Post op: Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
63213|NCT01791413|O3|Outcome|3 mo. Post op: No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
63214|NCT01791413|O2|Outcome|2 wk Post op:Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
63215|NCT01791413|O1|Outcome|2 wk Post op : No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
63216|NCT01791413|E1|Reported Event|DMPA|
63217|NCT01791205|B3|Baseline|Total|Total of all reporting groups
63218|NCT01791205|B2|Baseline|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63219|NCT01791205|B1|Baseline|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63220|NCT01791205|P2|Participant Flow|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63221|NCT01791205|P1|Participant Flow|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63222|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63223|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63224|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63225|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63226|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63227|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63228|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63229|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63230|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63231|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63232|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63233|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63234|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63235|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63236|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63237|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63238|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63239|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63240|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63308|NCT01789775|B1|Baseline|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
63309|NCT01789775|P2|Participant Flow|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
63241|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63242|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63243|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63244|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63245|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63246|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63247|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63248|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63249|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63250|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63251|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63252|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63253|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63254|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63255|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63256|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63257|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63258|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63259|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63260|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63261|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63310|NCT01789775|P1|Participant Flow|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
63311|NCT01789775|O2|Outcome|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
63262|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63263|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63264|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63265|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63266|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63267|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63268|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63269|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
63270|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63271|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63272|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63273|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63274|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63275|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63276|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63277|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63278|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63279|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63280|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63281|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63312|NCT01789775|O1|Outcome|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
63313|NCT01789775|E2|Reported Event|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
63282|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63283|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63284|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63285|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63286|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63287|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63288|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63289|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63290|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63291|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63292|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63293|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63294|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63295|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63296|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63297|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
63298|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63299|NCT01791205|E1|Reported Event|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
63300|NCT01791127|B1|Baseline|Pre-Market Study Cohort|
63301|NCT01791127|P1|Participant Flow|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
63302|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
63303|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
63304|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
63305|NCT01791127|E1|Reported Event|Pre-Market Study Cohort|The total number of subjects includes all subjects from the Pre-Market Study cohort who experienced any adverse event and/or reached the 12-month follow-up time point.
63317|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63318|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63319|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63320|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63321|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63322|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63323|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63324|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63325|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63326|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63327|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63328|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63329|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63330|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63331|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63332|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63333|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63334|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63335|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63336|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63337|NCT01790828|E1|Reported Event|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
63338|NCT01790750|B1|Baseline|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
63339|NCT01790750|P1|Participant Flow|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
63340|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
63341|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minutePocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
63342|NCT01790750|E1|Reported Event|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
63343|NCT01790685|B3|Baseline|Total|Total of all reporting groups
63344|NCT01790685|B2|Baseline|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
63345|NCT01790685|B1|Baseline|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
63346|NCT01790685|P2|Participant Flow|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
63347|NCT01790685|P1|Participant Flow|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
63348|NCT01790685|O2|Outcome|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
63349|NCT01790685|O1|Outcome|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
63350|NCT01790685|E2|Reported Event|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
63351|NCT01790685|E1|Reported Event|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
63352|NCT01790633|B3|Baseline|Total|Total of all reporting groups
63353|NCT01790633|B2|Baseline|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63354|NCT01790633|B1|Baseline|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63541|NCT01788163|O9|Outcome|Thailand-Mutation Status Positive|Subjects in Thailand that meet I/E and population criteria, who had a Positive Mutation Status.
63355|NCT01790633|P2|Participant Flow|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63356|NCT01790633|P1|Participant Flow|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63357|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63358|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63359|NCT01790633|O1|Outcome|Screened for Eligibility|Individuals who were screened for eligibility, prior to being considered for randomization.
63360|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63361|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63362|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63363|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63364|NCT01790633|E2|Reported Event|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
63365|NCT01790633|E1|Reported Event|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
63366|NCT01790581|B3|Baseline|Total|Total of all reporting groups
63367|NCT01790581|B2|Baseline|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
63368|NCT01790581|B1|Baseline|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
63369|NCT01790581|P2|Participant Flow|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
63383|NCT01790516|O1|Outcome|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
63384|NCT01790516|E2|Reported Event|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
63542|NCT01788163|O8|Outcome|Australia-Mutation Status Negative|Subjects in Australia that meet I/E and population criteria, who had a Negative Mutation Status.
63370|NCT01790581|P1|Participant Flow|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
63371|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
63372|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
63373|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
63374|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
63375|NCT01790581|E2|Reported Event|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
63376|NCT01790581|E1|Reported Event|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
63377|NCT01790516|B3|Baseline|Total|Total of all reporting groups
63378|NCT01790516|B2|Baseline|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
63379|NCT01790516|B1|Baseline|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
63380|NCT01790516|P2|Participant Flow|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
63381|NCT01790516|P1|Participant Flow|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
63382|NCT01790516|O2|Outcome|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
63423|NCT01789476|P1|Participant Flow|CR845|CR845 (0.005 mg/kg) IV
63385|NCT01790516|E1|Reported Event|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
63386|NCT01790490|B4|Baseline|Total|Total of all reporting groups
63387|NCT01790490|B3|Baseline|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
63388|NCT01790490|B2|Baseline|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
63389|NCT01790490|B1|Baseline|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
63390|NCT01790490|P3|Participant Flow|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
63391|NCT01790490|P2|Participant Flow|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
63392|NCT01790490|P1|Participant Flow|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
63393|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K1|Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
63394|NCT01790490|O2|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
63395|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
63396|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|"Lorazepam 2 mg infused over 52 minutes (LZP)~Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control."
63397|NCT01790490|O2|Outcome|Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)|"Ketamine 0.71 mg/kg infused over 52 min (K2)~Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings."
63398|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|"Ketamine 0.41 mg/kg infused over 52 min (K1)~Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg"
63399|NCT01790490|E3|Reported Event|Ketamine 0.71 (K2)|Ketamine 0.71 mg/kg over 52 minutes (K2)
63400|NCT01790490|E2|Reported Event|Lorazepam 2 mg (LZP)|Lorazepam 2 mg (LZP) over 52 minutes
63401|NCT01790490|E1|Reported Event|Ketamine 0.41 (K1)|Ketamine 0.41 (K1) over 52 minutes
63402|NCT01790178|B3|Baseline|Total|Total of all reporting groups
63403|NCT01790178|B2|Baseline|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63404|NCT01790178|B1|Baseline|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63405|NCT01790178|P2|Participant Flow|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63406|NCT01790178|P1|Participant Flow|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63407|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63408|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63409|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63410|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63411|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63412|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63413|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63414|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63415|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63416|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63417|NCT01790178|E2|Reported Event|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
63418|NCT01790178|E1|Reported Event|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
63419|NCT01789476|B3|Baseline|Total|Total of all reporting groups
63420|NCT01789476|B2|Baseline|Placebo|Matched placebo
63421|NCT01789476|B1|Baseline|CR845|CR845 (0.005 mg/kg) IV
63422|NCT01789476|P2|Participant Flow|Placebo|Matched placebo
63432|NCT01789255|B1|Baseline|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
63433|NCT01789255|P1|Participant Flow|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
63434|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
63435|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
63436|NCT01789255|E1|Reported Event|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
63437|NCT01789138|B3|Baseline|Total|Total of all reporting groups
63438|NCT01789138|B2|Baseline|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
63439|NCT01789138|B1|Baseline|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
63440|NCT01789138|P2|Participant Flow|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
63441|NCT01789138|P1|Participant Flow|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
63442|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
63443|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
63444|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
63445|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
63446|NCT01789138|E2|Reported Event|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
63478|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63447|NCT01789138|E1|Reported Event|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
63448|NCT01788566|B1|Baseline|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63449|NCT01788566|P1|Participant Flow|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63450|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63451|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63452|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63453|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63454|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63455|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63456|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63457|NCT01788566|E1|Reported Event|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
63458|NCT01788358|B1|Baseline|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63459|NCT01788358|P1|Participant Flow|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63460|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63461|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63601|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63462|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63463|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63464|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63465|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63466|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63467|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63468|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63469|NCT01788358|E1|Reported Event|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
63470|NCT01788228|B3|Baseline|Total|Total of all reporting groups
63471|NCT01788228|B2|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63472|NCT01788228|B1|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63473|NCT01788228|P2|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63474|NCT01788228|P1|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63475|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63476|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63477|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63602|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63479|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63480|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63481|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63482|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63483|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63484|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63485|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63486|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63487|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63488|NCT01788228|E2|Reported Event|Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group|Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63489|NCT01788228|E1|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
63490|NCT01788215|B3|Baseline|Total|Total of all reporting groups
63491|NCT01788215|B2|Baseline|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63492|NCT01788215|B1|Baseline|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63493|NCT01788215|P2|Participant Flow|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63494|NCT01788215|P1|Participant Flow|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63495|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63496|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63497|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63498|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63499|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63500|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63501|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63603|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63502|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63503|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63504|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63505|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63506|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63507|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63508|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63509|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63510|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63511|NCT01788215|E2|Reported Event|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
63512|NCT01788215|E1|Reported Event|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
63513|NCT01788163|B10|Baseline|Total|Total of all reporting groups
63514|NCT01788163|B9|Baseline|Russia|Subjects in Russia that meet I/E and population criteria
63515|NCT01788163|B8|Baseline|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63516|NCT01788163|B7|Baseline|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63517|NCT01788163|B6|Baseline|Singapore|Subjects in Singapore that meet I/E and population criteria
63518|NCT01788163|B5|Baseline|Thailand|Subjects in Thailand that meet I/E and population criteria
63519|NCT01788163|B4|Baseline|Australia|Subjects in Australia that meet I/E and population criteria
63520|NCT01788163|B3|Baseline|South Korea|Subjects in South Korea that meet I/E and population criteria
63521|NCT01788163|B2|Baseline|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63522|NCT01788163|B1|Baseline|China|Subjects in China that meet I/E and population criteria.
63523|NCT01788163|P9|Participant Flow|Russia|Subjects in Russia that meet I/E and population criteria
63524|NCT01788163|P8|Participant Flow|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63525|NCT01788163|P7|Participant Flow|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63526|NCT01788163|P6|Participant Flow|Singapore|Subjects in Singapore that meet I/E and population criteria
63527|NCT01788163|P5|Participant Flow|Thailand|Subjects in Thailand that meet I/E and population criteria
63528|NCT01788163|P4|Participant Flow|Australia|Subjects in Australia that meet I/E and population criteria
63529|NCT01788163|P3|Participant Flow|South Korea|Subjects in South Korea that meet I/E and population criteria
63530|NCT01788163|P2|Participant Flow|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63531|NCT01788163|P1|Participant Flow|China|Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
63532|NCT01788163|O18|Outcome|Russia-Mutation Status Negative|Subjects in Russia that meet I/E and population criteria, who had a Negative Mutation Status.
63533|NCT01788163|O17|Outcome|Russia-Mutation Status Positive|Subjects in Russia that meet I/E and population criteria, who had a Positive Mutation Status.
63534|NCT01788163|O16|Outcome|Indonesia-Mutation Status Negative|Subjects in Indonesia that meet I/E and population criteria, who had a Negative Mutation Status.
63535|NCT01788163|O15|Outcome|Indonesia-Mutation Status Positive|Subjects in Indonesia that meet I/E and population criteria, who had a Positive Mutation Status.
63536|NCT01788163|O14|Outcome|Malaysia-Mutation Status Negative|Subjects in Malaysia that meet I/E and population criteria, who had a Negative Mutation Status.
63537|NCT01788163|O13|Outcome|Malaysia-Mutation Status Positive|Subjects in Malaysia that meet I/E and population criteria, who had a Positive Mutation Status.
63538|NCT01788163|O12|Outcome|Singapore-Mutation Status Negative|Subjects in Singapore that meet I/E and population criteria, who had a Negative Mutation Status.
63539|NCT01788163|O11|Outcome|Singapore-Mutation Status Positive|Subjects in Singapore that meet I/E and population criteria, who had a Positive Mutation Status.
63604|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63543|NCT01788163|O7|Outcome|Australia-Mutation Status Positive|Subjects in Australia that meet I/E and population criteria, who had a Positive Mutation Status.
63544|NCT01788163|O6|Outcome|South Korea-Mutation Status Negative|Subjects in South Korea that meet I/E and population criteria, who had a Negative Mutation Status.
63545|NCT01788163|O5|Outcome|South Korea-Mutation Status Positive|Subjects in South Korea that meet I/E and population criteria, who had a Positive Mutation Status.
63546|NCT01788163|O4|Outcome|Taiwan-Mutation Status Negative|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status.
63547|NCT01788163|O3|Outcome|Taiwan-Mutation Status Positive|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status.
63548|NCT01788163|O2|Outcome|China-Mutation Status Negative|Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status.
63549|NCT01788163|O1|Outcome|China-Mutation Status Positive|Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status.
63550|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63551|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63552|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63553|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63554|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
63555|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
63556|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63557|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63558|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63559|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63560|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63561|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63562|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63563|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63564|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63565|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63566|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63567|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63568|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63569|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
63570|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
63571|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63572|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63573|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63574|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria
63575|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63576|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63577|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63578|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63579|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63580|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63581|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63582|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63583|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63584|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63585|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63586|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63587|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
63588|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
63589|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63590|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63591|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63592|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63593|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63594|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63595|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63596|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
63597|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
63598|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63599|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63600|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63610|NCT01788163|O8|Outcome|Russia - Negative Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Negative Predictive test performed.
63611|NCT01788163|O7|Outcome|Russia - Positive Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Positive Predictive test performed.
63612|NCT01788163|O6|Outcome|South Korea - Negative Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Negative Predictive test performed.
63613|NCT01788163|O5|Outcome|South Korea - Positive Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Positive Predictive test performed.
63614|NCT01788163|O4|Outcome|Taiwan - Negative Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed.
63615|NCT01788163|O3|Outcome|Taiwan - Positive Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed.
63616|NCT01788163|O2|Outcome|China - Negative Predictive Value|Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed.
63617|NCT01788163|O1|Outcome|China - Positive Predictive Value|Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed.
63618|NCT01788163|O8|Outcome|Russia - Specificity|Subjects in Russia that meet I/E and population criteria, who had a specificity test performed.
63619|NCT01788163|O7|Outcome|Russia - Sensitivity|Subjects in Russia that meet I/E and population criteria, who had a sensitivity test performed.
63620|NCT01788163|O6|Outcome|South Korea - Specificity|Subjects in South Korea that meet I/E and population criteria, who had a specificity test performed.
63621|NCT01788163|O5|Outcome|South Korea - Sensitivity|Subjects in South Korea that meet I/E and population criteria, who had a sensitivity test performed.
63622|NCT01788163|O4|Outcome|Taiwan - Specificity|Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed.
63623|NCT01788163|O3|Outcome|Taiwan - Sensitivity|Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed.
63624|NCT01788163|O2|Outcome|China - Specificty|Subjects in China that meet I/E and population criteria, who had a specificity test performed.
63625|NCT01788163|O1|Outcome|China - Sensitivity|Subjects in China that meet I/E and population criteria, who had a sensitivity test performed.
63626|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63627|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63628|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63629|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63630|NCT01788163|O8|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63631|NCT01788163|O7|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
63632|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63633|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
63634|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63635|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
63636|NCT01788163|O2|Outcome|China-Non-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63637|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
63638|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63639|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63640|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63641|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63642|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63643|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63644|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63645|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63646|NCT01788163|O18|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63647|NCT01788163|O17|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
63648|NCT01788163|O16|Outcome|Indonesia-Non-adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63649|NCT01788163|O15|Outcome|Indonesia-Adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
63650|NCT01788163|O14|Outcome|Malaysia-Non-adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63651|NCT01788163|O13|Outcome|Malaysia-Adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
63652|NCT01788163|O12|Outcome|Singapore-Non-adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63653|NCT01788163|O11|Outcome|Singapore-Adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
63654|NCT01788163|O10|Outcome|Thailand-Non-adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63655|NCT01788163|O9|Outcome|Thailand-Adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Adenocarcinoma.
63656|NCT01788163|O8|Outcome|Australia-Non-adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63657|NCT01788163|O7|Outcome|Australia-Adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Adenocarcinoma.
63658|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63659|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
63660|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63661|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
63662|NCT01788163|O2|Outcome|China-Non-adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
63663|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
63664|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63665|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63666|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63667|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63668|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
63669|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
63670|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63671|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63672|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63673|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
63674|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63675|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63676|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
63677|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
63678|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
63679|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
63680|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63681|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
63682|NCT01788163|E9|Reported Event|Russia|Subjects in Russia that meet I/E and population criteria
63683|NCT01788163|E8|Reported Event|Indonesia|Subjects in Indonesia that meet I/E and population criteria
63684|NCT01788163|E7|Reported Event|Malaysia|Subjects in Malaysia that meet I/E and population criteria
63685|NCT01788163|E6|Reported Event|Singapore|Subjects in Singapore that meet I/E and population criteria
63686|NCT01788163|E5|Reported Event|Thailand|Subjects in Thailand that meet I/E and population criteria
63687|NCT01788163|E4|Reported Event|Australia|Subjects in Australia that meet I/E and population criteria
63688|NCT01788163|E3|Reported Event|South Korea|Subjects in South Korea that meet I/E and population criteria
63689|NCT01788163|E2|Reported Event|Taiwan|Subjects in Taiwan that meet I/E and population criteria
63690|NCT01788163|E1|Reported Event|China|Subjects in China that meet I/E and population criteria.
63691|NCT01787838|B1|Baseline|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
63692|NCT01787838|P1|Participant Flow|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
63693|NCT01787838|O1|Outcome|Health Education, Audit and Feedback|"Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations."
63694|NCT01787838|E1|Reported Event|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
63695|NCT01787799|B1|Baseline|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
63770|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63696|NCT01787799|P1|Participant Flow|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
63697|NCT01787799|O1|Outcome|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
63698|NCT01787799|E1|Reported Event|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
63699|NCT01787760|B4|Baseline|Total|Total of all reporting groups
63700|NCT01787760|B3|Baseline|Spectacle Lenses|Control spectacle lenses worn daily.
63701|NCT01787760|B2|Baseline|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
63702|NCT01787760|B1|Baseline|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
63703|NCT01787760|P3|Participant Flow|Spectacle Lenses|Control spectacle lenses worn daily.
63704|NCT01787760|P2|Participant Flow|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
63705|NCT01787760|P1|Participant Flow|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
63706|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
63707|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
63708|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
63709|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
63710|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
63711|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
63712|NCT01787760|E4|Reported Event|Not Randomized|Subjects who met the all study eligible criteria but did not randomize to the study arm.
63713|NCT01787760|E3|Reported Event|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
63714|NCT01787760|E2|Reported Event|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
63715|NCT01787760|E1|Reported Event|Spectacle Lenses|Control spectacle lenses worn daily.
63716|NCT01787591|B3|Baseline|Total|Total of all reporting groups
63717|NCT01787591|B2|Baseline|Metabolic Syndrome Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
63718|NCT01787591|B1|Baseline|Healthy Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
63719|NCT01787591|P4|Participant Flow|Acute Soy Milk Ingestion First|"Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.~Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63720|NCT01787591|P3|Participant Flow|Acute Full-Fat Milk Ingestion First|"Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.~Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63721|NCT01787591|P2|Participant Flow|Acute Low-Fat Milk Ingestion First|"Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63722|NCT01787591|P1|Participant Flow|Acute Fat-Free Milk Ingestion First|"Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63723|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
63724|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63725|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63726|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63727|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
63728|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63729|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63730|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63731|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
63771|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63732|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63733|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63734|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63735|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
63736|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63737|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63738|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63739|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
63740|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63741|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63742|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63743|NCT01787591|E4|Reported Event|Acute Soy Milk Ingestion|"Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63744|NCT01787591|E3|Reported Event|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63745|NCT01787591|E2|Reported Event|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63746|NCT01787591|E1|Reported Event|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
63747|NCT01787461|B3|Baseline|Total|Total of all reporting groups
63748|NCT01787461|B2|Baseline|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63749|NCT01787461|B1|Baseline|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63750|NCT01787461|P2|Participant Flow|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63751|NCT01787461|P1|Participant Flow|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63752|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63753|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63754|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63755|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63756|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63757|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63758|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63759|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63760|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63761|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63762|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63763|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63764|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63765|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63766|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63767|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63768|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63772|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63773|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63774|NCT01787461|E2|Reported Event|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
63775|NCT01787461|E1|Reported Event|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
63776|NCT01787383|B3|Baseline|Total|Total of all reporting groups
63777|NCT01787383|B2|Baseline|Ingenol Mebutate Gel Sequential Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially"
63778|NCT01787383|B1|Baseline|Ingenol Mebutate Gel Simultaneous Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously"
63779|NCT01787383|P2|Participant Flow|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63780|NCT01787383|P1|Participant Flow|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63781|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
63782|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
63783|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
63784|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
63785|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side Effects TSQM compliance was lower than the number of randomised subjects.
63786|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side EffectsTSQM compliance was lower than the number of randomised subjects.
63787|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
63788|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
63789|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63790|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63791|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63792|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63835|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63836|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63837|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63793|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63794|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63795|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63796|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63797|NCT01787383|E2|Reported Event|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63798|NCT01787383|E1|Reported Event|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
63799|NCT01787279|B1|Baseline|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63800|NCT01787279|P1|Participant Flow|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63801|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63802|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63803|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63804|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63805|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63806|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63807|NCT01787279|E1|Reported Event|Peginterferon Alpha-2a, 180 mcg/ 48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
63808|NCT01787188|B4|Baseline|Total|Total of all reporting groups
63809|NCT01787188|B3|Baseline|Placebo|Placebo: Capsule
63810|NCT01787188|B2|Baseline|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63811|NCT01787188|B1|Baseline|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63812|NCT01787188|P3|Participant Flow|Placebo|Placebo: Capsule
63813|NCT01787188|P2|Participant Flow|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63814|NCT01787188|P1|Participant Flow|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63815|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63816|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63817|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63818|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63819|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63820|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63821|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63822|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63823|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63824|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63825|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63826|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63827|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63828|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63829|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63830|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63831|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63832|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63833|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63834|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63840|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63841|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63842|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63843|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63844|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63845|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63846|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63847|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63848|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63849|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63850|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63851|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63852|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63853|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63854|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63855|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63856|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63857|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63858|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63859|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63860|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
63861|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63862|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63863|NCT01787188|E3|Reported Event|Placebo|Placebo: Capsule
63864|NCT01787188|E2|Reported Event|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
63865|NCT01787188|E1|Reported Event|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
63866|NCT01787175|B3|Baseline|Total|Total of all reporting groups
63867|NCT01787175|B2|Baseline|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63868|NCT01787175|B1|Baseline|Integration Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63869|NCT01787175|P2|Participant Flow|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63870|NCT01787175|P1|Participant Flow|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63871|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63872|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63873|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63874|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63875|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63876|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
63877|NCT01787175|E2|Reported Event|Standard EHR|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
63878|NCT01787175|E1|Reported Event|Integrated Medication Manager|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
63879|NCT01786993|B3|Baseline|Total|Total of all reporting groups
64132|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
63880|NCT01786993|B2|Baseline|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
63881|NCT01786993|B1|Baseline|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
63882|NCT01786993|P2|Participant Flow|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
63883|NCT01786993|P1|Participant Flow|Multi-point Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
63884|NCT01786993|O2|Outcome|Biventricular Arm|"Traditional Biventricular Pacing~Traditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available."
63885|NCT01786993|O1|Outcome|MultiPoint Pacing Arm|"MultiPoint Pacing~MultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study."
63886|NCT01786993|O1|Outcome|BiV/MPP Patients|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).
63887|NCT01786993|E2|Reported Event|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
63888|NCT01786993|E1|Reported Event|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
63889|NCT01786954|B1|Baseline|Icare, Goldmann, Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
63890|NCT01786954|P2|Participant Flow|Sequence 2: Icare Then Tonopen Then Goldmann|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
63891|NCT01786954|P1|Participant Flow|Sequence 1: Icare Then Goldmann Then Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation.~Icare rebound tonometry~Goldmann applanation~Tonopen applanation"
63892|NCT01786954|O3|Outcome|Goldmann|
63893|NCT01786954|O2|Outcome|Tonopen|
63894|NCT01786954|O1|Outcome|Icare|
63895|NCT01786954|O3|Outcome|Goldmann|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
63896|NCT01786954|O2|Outcome|Tonopen|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
63897|NCT01786954|O1|Outcome|Icare|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry"
63898|NCT01786954|E2|Reported Event|Sequence 2: Icare, Tonopen, Goldmann|Sequence 2: Icare, then Tonopen, then Goldmann
63899|NCT01786954|E1|Reported Event|Sequence 1: Icare, Goldmann, Tonopen|Sequence 1: Icare, then Goldmann, then Tonopen
63900|NCT01786902|B3|Baseline|Total|Total of all reporting groups
63901|NCT01786902|B2|Baseline|Non-treatment Control Group|Height be measured with no treatment
63902|NCT01786902|B1|Baseline|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63903|NCT01786902|P2|Participant Flow|Non-treatment Control Group|Height be measured with no treatment
63904|NCT01786902|P1|Participant Flow|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63905|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
63906|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63907|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
63908|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63909|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
63910|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63911|NCT01786902|E2|Reported Event|Non-treatment Control Group|Height be measured with no treatment
63912|NCT01786902|E1|Reported Event|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
63913|NCT01786876|B1|Baseline|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63914|NCT01786876|P1|Participant Flow|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63915|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63916|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63917|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63918|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63919|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63920|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
65612|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
63921|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63922|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63923|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63924|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63925|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63926|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63927|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63928|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63929|NCT01786876|E1|Reported Event|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
63930|NCT01786707|B3|Baseline|Total|Total of all reporting groups
63931|NCT01786707|B2|Baseline|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
63932|NCT01786707|B1|Baseline|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
63933|NCT01786707|P2|Participant Flow|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
63934|NCT01786707|P1|Participant Flow|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
63935|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
63936|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
63937|NCT01786707|E2|Reported Event|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
63938|NCT01786707|E1|Reported Event|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
63939|NCT01786668|B5|Baseline|Total|Total of all reporting groups
63940|NCT01786668|B4|Baseline|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63941|NCT01786668|B3|Baseline|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63942|NCT01786668|B2|Baseline|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63943|NCT01786668|B1|Baseline|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63944|NCT01786668|P4|Participant Flow|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63945|NCT01786668|P3|Participant Flow|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63946|NCT01786668|P2|Participant Flow|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63947|NCT01786668|P1|Participant Flow|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.
63948|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63949|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63950|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63951|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63952|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63953|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63954|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64133|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
63955|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63956|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63957|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63958|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63959|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63960|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63961|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63962|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63963|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63964|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63965|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63966|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63967|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63968|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63969|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63970|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63971|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63972|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63973|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63974|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63975|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63976|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63977|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63978|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63979|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63980|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63981|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63982|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63983|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63984|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63985|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64134|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
65613|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
63986|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63987|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63988|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63989|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63990|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63991|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63992|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63993|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63994|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63995|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63996|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63997|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
63998|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
63999|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64000|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64001|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64002|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64003|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64004|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64005|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64006|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64007|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64008|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64009|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64010|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64011|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64012|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64013|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64014|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64015|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64016|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64135|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
105636|NCT01568073|E4|Reported Event|OPC 25mg|OPC, Opicapone 25mg
64017|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64018|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64019|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64020|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64021|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64022|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64023|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64024|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64025|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64026|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64027|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64028|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64029|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64030|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64031|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64032|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64033|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64034|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64035|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64036|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64037|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64038|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64039|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64040|NCT01786668|E4|Reported Event|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64041|NCT01786668|E3|Reported Event|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
64042|NCT01786668|E2|Reported Event|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64043|NCT01786668|E1|Reported Event|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
64044|NCT01786629|B3|Baseline|Total|Total of all reporting groups
64045|NCT01786629|B2|Baseline|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
64046|NCT01786629|B1|Baseline|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
64047|NCT01786629|P2|Participant Flow|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
64048|NCT01786629|P1|Participant Flow|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
64136|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64049|NCT01786629|O2|Outcome|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
64050|NCT01786629|O1|Outcome|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
64051|NCT01786629|E2|Reported Event|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
64052|NCT01786629|E1|Reported Event|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
64053|NCT01786330|B3|Baseline|Total|Total of all reporting groups
64054|NCT01786330|B2|Baseline|Control|"Group receives standard of care~Standard of Care"
64055|NCT01786330|B1|Baseline|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64056|NCT01786330|P2|Participant Flow|Control|"Group receives standard of care~Standard of Care"
64057|NCT01786330|P1|Participant Flow|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64058|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
64059|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64060|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
64061|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64062|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
64063|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64064|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
64065|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64066|NCT01786330|E2|Reported Event|Control|"Group receives standard of care~Standard of Care"
64067|NCT01786330|E1|Reported Event|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
64068|NCT01786252|B3|Baseline|Total|Total of all reporting groups
64069|NCT01786252|B2|Baseline|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64070|NCT01786252|B1|Baseline|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64071|NCT01786252|P2|Participant Flow|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64072|NCT01786252|P1|Participant Flow|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64073|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64074|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64075|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64076|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64077|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64078|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64079|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
64080|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
64081|NCT01786252|E2|Reported Event|hCG Group|
64082|NCT01786252|E1|Reported Event|Vehicle Group|
64083|NCT01786239|B3|Baseline|Total|Total of all reporting groups
64084|NCT01786239|B2|Baseline|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
64085|NCT01786239|B1|Baseline|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
64086|NCT01786239|P2|Participant Flow|Amber50/50 Soybean Corn Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
64087|NCT01786239|P1|Participant Flow|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
64088|NCT01786239|O2|Outcome|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
64089|NCT01786239|O1|Outcome|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
64137|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64138|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64139|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64140|NCT01786109|E3|Reported Event|Placebo|One dose of placebo will be taken orally with water.
64090|NCT01786239|E2|Reported Event|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
64091|NCT01786239|E1|Reported Event|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
64092|NCT01786174|B3|Baseline|Total|Total of all reporting groups
64093|NCT01786174|B2|Baseline|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64094|NCT01786174|B1|Baseline|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64095|NCT01786174|P2|Participant Flow|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64096|NCT01786174|P1|Participant Flow|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64097|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64098|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64099|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64100|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64101|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64102|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64103|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64104|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64105|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64106|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64107|NCT01786174|E2|Reported Event|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
64108|NCT01786174|E1|Reported Event|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
64109|NCT01786109|B4|Baseline|Total|Total of all reporting groups
64110|NCT01786109|B3|Baseline|Placebo|One dose of placebo will be taken orally with water.
64111|NCT01786109|B2|Baseline|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64112|NCT01786109|B1|Baseline|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64113|NCT01786109|P3|Participant Flow|Placebo|One dose of placebo will be taken orally with water.
64114|NCT01786109|P2|Participant Flow|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64115|NCT01786109|P1|Participant Flow|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64116|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64117|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64118|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64119|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64120|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64121|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64122|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64123|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64124|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64125|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64126|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64127|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64128|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64129|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64130|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64131|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
64141|NCT01786109|E2|Reported Event|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
64142|NCT01786109|E1|Reported Event|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
64143|NCT01785628|B3|Baseline|Total|Total of all reporting groups
64144|NCT01785628|B2|Baseline|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64145|NCT01785628|B1|Baseline|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64146|NCT01785628|P2|Participant Flow|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64147|NCT01785628|P1|Participant Flow|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64148|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64149|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64150|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64151|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64152|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64153|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64154|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64155|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64156|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64157|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64158|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64159|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64160|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64161|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64162|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64163|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64164|NCT01785628|E2|Reported Event|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
64165|NCT01785628|E1|Reported Event|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
64166|NCT01785602|B3|Baseline|Total|Total of all reporting groups
64167|NCT01785602|B2|Baseline|Placebo|Participants received matching placebo to QAW039.
64168|NCT01785602|B1|Baseline|QAW039|Participants received QAW039 450 mg daily by mouth.
64169|NCT01785602|P2|Participant Flow|Placebo|Participants received matching placebo to QAW039.
64170|NCT01785602|P1|Participant Flow|QAW039|Participants received QAW039 450 mg daily by mouth.
64171|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
64172|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
64173|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
64174|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
64175|NCT01785602|E2|Reported Event|Placebo|Participants received matching placebo to QAW039.
64176|NCT01785602|E1|Reported Event|QAW039|Participants received QAW039 450 mg daily by mouth.
64177|NCT01785524|B3|Baseline|Total|Total of all reporting groups
64178|NCT01785524|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64179|NCT01785524|B1|Baseline|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64180|NCT01785524|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64578|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64181|NCT01785524|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64182|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64183|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64184|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64185|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64186|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64187|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64188|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64579|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64189|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64190|NCT01785524|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
64191|NCT01785524|E1|Reported Event|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
64192|NCT01785472|B4|Baseline|Total|Total of all reporting groups
64193|NCT01785472|B3|Baseline|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64194|NCT01785472|B2|Baseline|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64195|NCT01785472|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64196|NCT01785472|P3|Participant Flow|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64197|NCT01785472|P2|Participant Flow|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64198|NCT01785472|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64199|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64200|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64201|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64202|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64203|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64204|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64205|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64206|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64207|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64208|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64209|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64311|NCT01784614|E2|Reported Event|1.0 mg LY2624803 - Periods 1-3|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64210|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64211|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64212|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64213|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64214|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64215|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64216|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64217|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64218|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64219|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64220|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64221|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64222|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64223|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64224|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64225|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64226|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64227|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64228|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64229|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64230|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64231|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64232|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64233|NCT01785472|O1|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64234|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
64235|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
64236|NCT01785472|E3|Reported Event|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
64237|NCT01785472|E2|Reported Event|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
64238|NCT01785472|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
64239|NCT01785160|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days.
64240|NCT01785160|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days.
64241|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
64242|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
64243|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
64244|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
64245|NCT01785160|E2|Reported Event|Raltegravir + Faldaprevir|"coated tablets and soft gelatine capsule, oral administration with 240 ml water~Raltegravir: low dose oral administration~Faldaprevir: medium dose oral administration"
64246|NCT01785160|E1|Reported Event|Raltegravir|"coated tablets, oral administration with 240 ml water~Raltegravir: low dose oral administration"
64247|NCT01785134|B3|Baseline|Total|Total of all reporting groups
64248|NCT01785134|B2|Baseline|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64249|NCT01785134|B1|Baseline|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64250|NCT01785134|P2|Participant Flow|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64251|NCT01785134|P1|Participant Flow|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64252|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64253|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64254|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64255|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64256|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64257|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64258|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64259|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64260|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64261|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64262|NCT01785134|E2|Reported Event|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
64263|NCT01785134|E1|Reported Event|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
64264|NCT01785095|B1|Baseline|Follicle Stimulating Hormone|
64265|NCT01785095|P1|Participant Flow|Follicle Stimulation Hormone|"FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.~FSH (Follicle Stimulating Hormone)"
64266|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle after 1 month of wash out.
64267|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
64268|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle performed after 1 month of wash out.
64269|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
64270|NCT01785095|O1|Outcome|Follicle Stimulationg Hormone|
64271|NCT01785095|E1|Reported Event|Follicle Stimulating Hormone|
64272|NCT01784614|B1|Baseline|Overall|"Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.~There was at least 7 days washout between each period."
64273|NCT01784614|P8|Participant Flow|Cohort 8|"Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
64274|NCT01784614|P7|Participant Flow|Cohort 7|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
64275|NCT01784614|P6|Participant Flow|Cohort 6|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
105637|NCT01568073|E3|Reported Event|OPC 5mg|OPC, Opicapone 5mg
64276|NCT01784614|P5|Participant Flow|Cohort 5|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
64277|NCT01784614|P4|Participant Flow|Cohort 4|"Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
64278|NCT01784614|P3|Participant Flow|Cohort 3|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
64279|NCT01784614|P2|Participant Flow|Cohort 2|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
64280|NCT01784614|P1|Participant Flow|Cohort 1|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
64281|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64282|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64283|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64284|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
64285|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64286|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64287|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
64288|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
64289|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64290|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64291|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64292|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64293|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
64294|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64295|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64296|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64297|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64298|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
64299|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64300|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64301|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64302|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64303|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
64304|NCT01784614|E9|Reported Event|6 mg LY2624803 - Period 4|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
64305|NCT01784614|E8|Reported Event|3.0 mg LY2624803 - Period 4|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
64306|NCT01784614|E7|Reported Event|1.0 mg LY2624803 - Period 4|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
64307|NCT01784614|E6|Reported Event|0.1 mg LY2624803 - Period 4|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4.
64308|NCT01784614|E5|Reported Event|Placebo - Periods 1-3|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64309|NCT01784614|E4|Reported Event|6.0 mg LY2624803 - Periods 1-3|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
64310|NCT01784614|E3|Reported Event|3.0 mg LY2624803 - Periods 1-3|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
105638|NCT01568073|E2|Reported Event|Entacapone|Entacapone - 200 mg
64312|NCT01784614|E1|Reported Event|0.1 mg LY2624803 - Periods 1-3|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
64313|NCT01783938|B3|Baseline|Total|Total of all reporting groups
64314|NCT01783938|B2|Baseline|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64315|NCT01783938|B1|Baseline|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64316|NCT01783938|P2|Participant Flow|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64317|NCT01783938|P1|Participant Flow|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64318|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64319|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64320|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64361|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64580|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64321|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64322|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64323|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64324|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64325|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64326|NCT01783938|E2|Reported Event|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64327|NCT01783938|E1|Reported Event|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
64328|NCT01783912|B4|Baseline|Total|Total of all reporting groups
64362|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64363|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
65614|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
64329|NCT01783912|B3|Baseline|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
64330|NCT01783912|B2|Baseline|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
64331|NCT01783912|B1|Baseline|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
64332|NCT01783912|P3|Participant Flow|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
64333|NCT01783912|P2|Participant Flow|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
64334|NCT01783912|P1|Participant Flow|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
64335|NCT01783912|O3|Outcome|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
64336|NCT01783912|O2|Outcome|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
64337|NCT01783912|O1|Outcome|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
64364|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64338|NCT01783912|E3|Reported Event|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
64339|NCT01783912|E2|Reported Event|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
64340|NCT01783912|E1|Reported Event|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
64341|NCT01783886|B4|Baseline|Total|Total of all reporting groups
64342|NCT01783886|B3|Baseline|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64343|NCT01783886|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64344|NCT01783886|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
64345|NCT01783886|P3|Participant Flow|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64346|NCT01783886|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64347|NCT01783886|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64348|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64349|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64350|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64351|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64352|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64353|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64354|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64355|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64356|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64357|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64358|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64359|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64360|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
65615|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
64365|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64366|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64367|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64368|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64369|NCT01783886|E3|Reported Event|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
64370|NCT01783886|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
64371|NCT01783886|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
64372|NCT01783860|B3|Baseline|Total|Total of all reporting groups
64373|NCT01783860|B2|Baseline|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64374|NCT01783860|B1|Baseline|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64375|NCT01783860|P2|Participant Flow|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64376|NCT01783860|P1|Participant Flow|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64377|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64378|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64379|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64380|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64381|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64382|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64383|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64384|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64385|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64386|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64387|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64388|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64389|NCT01783860|E2|Reported Event|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
64390|NCT01783860|E1|Reported Event|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
64391|NCT01783821|B3|Baseline|Total|Total of all reporting groups
64392|NCT01783821|B2|Baseline|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64393|NCT01783821|B1|Baseline|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64394|NCT01783821|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64395|NCT01783821|P1|Participant Flow|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64396|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64397|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64398|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64399|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64400|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
105639|NCT01568073|E1|Reported Event|Placebo|Placebo 200 mg
64401|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64402|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64403|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64404|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64405|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64406|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64407|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64408|NCT01783821|E2|Reported Event|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
64409|NCT01783821|E1|Reported Event|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
64410|NCT01783730|B1|Baseline|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64411|NCT01783730|P1|Participant Flow|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64412|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64413|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64414|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64415|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64416|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64417|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64418|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64419|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64420|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64421|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64422|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64423|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64424|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64425|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64426|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64427|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64428|NCT01783730|E1|Reported Event|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
64429|NCT01783678|B7|Baseline|Total|Total of all reporting groups
64430|NCT01783678|B6|Baseline|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64431|NCT01783678|B5|Baseline|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64432|NCT01783678|B4|Baseline|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64433|NCT01783678|B3|Baseline|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64434|NCT01783678|B2|Baseline|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64435|NCT01783678|B1|Baseline|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64436|NCT01783678|P6|Participant Flow|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64437|NCT01783678|P5|Participant Flow|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64438|NCT01783678|P4|Participant Flow|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64439|NCT01783678|P3|Participant Flow|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64440|NCT01783678|P2|Participant Flow|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64441|NCT01783678|P1|Participant Flow|Genotype 2 Treatment-naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64442|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64443|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64444|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64445|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64446|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64447|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64448|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64449|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64450|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64451|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64452|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64453|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64454|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64455|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64456|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64457|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64458|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64459|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64460|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64461|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64462|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64463|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64464|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64465|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64575|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64466|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64467|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64468|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64469|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64470|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64471|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64472|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64473|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64474|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64475|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64476|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64477|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64478|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64479|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64480|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64481|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64482|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64483|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64484|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64485|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64486|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64487|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64488|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64489|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64490|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64491|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64492|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64493|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64494|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64576|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64495|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64496|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64497|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64498|NCT01783678|O3|Outcome|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
64499|NCT01783678|O2|Outcome|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
64500|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64501|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
64502|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
64503|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
64504|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
64505|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64506|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
64507|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
64508|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64509|NCT01783678|E3|Reported Event|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
64510|NCT01783678|E2|Reported Event|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
64511|NCT01783678|E1|Reported Event|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
64512|NCT01783639|B1|Baseline|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
64513|NCT01783639|P1|Participant Flow|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
64514|NCT01783639|O1|Outcome|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
64515|NCT01783639|E1|Reported Event|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
64516|NCT01783548|B3|Baseline|Total|Total of all reporting groups
64517|NCT01783548|B2|Baseline|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64518|NCT01783548|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64519|NCT01783548|P2|Participant Flow|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64520|NCT01783548|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64521|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64522|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64523|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64577|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64524|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64525|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64526|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64527|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64528|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64529|NCT01783548|E2|Reported Event|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
64530|NCT01783548|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
64531|NCT01783496|B7|Baseline|Total|Total of all reporting groups
64532|NCT01783496|B6|Baseline|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
64533|NCT01783496|B5|Baseline|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
64534|NCT01783496|B4|Baseline|Total Tip|Treatment with the Thermage CPT Total tip
64535|NCT01783496|B3|Baseline|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
64536|NCT01783496|B2|Baseline|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
64537|NCT01783496|B1|Baseline|Framed Tip|Treatment with Thermage CPT Framed Tip
64538|NCT01783496|P6|Participant Flow|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
64539|NCT01783496|P5|Participant Flow|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
64540|NCT01783496|P4|Participant Flow|Total Tip|Treatment with the Thermage CPT Total tip
64541|NCT01783496|P3|Participant Flow|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
64542|NCT01783496|P2|Participant Flow|Pattern Tip|Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
64543|NCT01783496|P1|Participant Flow|Framed Tip|Treatment with Thermage CPT Framed Tip
64544|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
64545|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
64546|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
64547|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
64548|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
64549|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
64550|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
64551|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
64552|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
64553|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
64554|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
64555|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
64556|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
64557|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
64558|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
64559|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
64560|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
64561|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
64562|NCT01783496|E6|Reported Event|Total and Patterned Tip|"Split face treatment with the Thermage CPT Total and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64563|NCT01783496|E5|Reported Event|Framed and Patterned Tip|"Split face treatment with the Thermage CPT Framed and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64564|NCT01783496|E4|Reported Event|Total Tip|"Treatment with the Thermage CPT Total tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64565|NCT01783496|E3|Reported Event|Pattern Tip Group 2|"Treatment with the Thermage CPT Pattern tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64566|NCT01783496|E2|Reported Event|Pattern Tip|"Treatment with the Thermage CPT Pattern Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64567|NCT01783496|E1|Reported Event|Framed Tip|"Treatment with Thermage CPT Framed Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
64568|NCT01783418|B3|Baseline|Total|Total of all reporting groups
64569|NCT01783418|B2|Baseline|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64570|NCT01783418|B1|Baseline|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64571|NCT01783418|P2|Participant Flow|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64572|NCT01783418|P1|Participant Flow|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64573|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64574|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64581|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64582|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64583|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64584|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64585|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64586|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64587|NCT01783418|E2|Reported Event|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64588|NCT01783418|E1|Reported Event|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
64589|NCT01783054|B1|Baseline|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64590|NCT01783054|P1|Participant Flow|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64591|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64592|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64593|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64594|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64595|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64596|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64597|NCT01783054|E1|Reported Event|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
64598|NCT01783015|B3|Baseline|Total|Total of all reporting groups
64599|NCT01783015|B2|Baseline|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64600|NCT01783015|B1|Baseline|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64601|NCT01783015|P3|Participant Flow|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64602|NCT01783015|P2|Participant Flow|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64603|NCT01783015|P1|Participant Flow|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64604|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64605|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64606|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64607|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64608|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64609|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64610|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64611|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64612|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64613|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64614|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64615|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64616|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64617|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64618|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64619|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64620|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64621|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64622|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64623|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64624|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64625|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64626|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64627|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64628|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64629|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64630|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64631|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64632|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64633|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64634|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64635|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64636|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64637|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64638|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64639|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64640|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64641|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64642|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64643|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64644|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64645|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64646|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64647|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64648|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64649|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64650|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64651|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64652|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64653|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64654|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64655|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64656|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64657|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64658|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64659|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
65616|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
64660|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64661|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64662|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64663|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64664|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64665|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64666|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64667|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64668|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64669|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64670|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64671|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64672|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64673|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64674|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64675|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64676|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64677|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64678|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64679|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64680|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64681|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64682|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64683|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64684|NCT01783015|E3|Reported Event|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
64685|NCT01783015|E2|Reported Event|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
64686|NCT01783015|E1|Reported Event|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
64687|NCT01782898|B3|Baseline|Total|Total of all reporting groups
64688|NCT01782898|B2|Baseline|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64689|NCT01782898|B1|Baseline|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64690|NCT01782898|P2|Participant Flow|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64691|NCT01782898|P1|Participant Flow|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64692|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64693|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64694|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64695|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64696|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64697|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64698|NCT01782898|E2|Reported Event|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
64699|NCT01782898|E1|Reported Event|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
64700|NCT01782885|B3|Baseline|Total|Total of all reporting groups
64701|NCT01782885|B2|Baseline|Intra-articular Injection of PRP|Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).
64702|NCT01782885|B1|Baseline|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.
64703|NCT01782885|P2|Participant Flow|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64704|NCT01782885|P1|Participant Flow|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64705|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64706|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64707|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64708|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64709|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64710|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64711|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64712|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64713|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64714|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64715|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64716|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64717|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64718|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64719|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64720|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64721|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64722|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64723|NCT01782885|E2|Reported Event|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
64724|NCT01782885|E1|Reported Event|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
64725|NCT01782872|B5|Baseline|Total|Total of all reporting groups
64726|NCT01782872|B4|Baseline|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64727|NCT01782872|B3|Baseline|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64728|NCT01782872|B2|Baseline|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64729|NCT01782872|B1|Baseline|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64730|NCT01782872|P4|Participant Flow|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64731|NCT01782872|P3|Participant Flow|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64732|NCT01782872|P2|Participant Flow|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64733|NCT01782872|P1|Participant Flow|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64734|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64735|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64736|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64737|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64738|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64739|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64740|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64741|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64742|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64743|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64744|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64745|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64746|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64747|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64748|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64749|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64750|NCT01782872|E4|Reported Event|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
64751|NCT01782872|E3|Reported Event|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64752|NCT01782872|E2|Reported Event|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
64753|NCT01782872|E1|Reported Event|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
64754|NCT01782859|B3|Baseline|Total|Total of all reporting groups
64755|NCT01782859|B2|Baseline|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64756|NCT01782859|B1|Baseline|Placebo|"Control group~Placebo (for Prednisone)"
64757|NCT01782859|P2|Participant Flow|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64758|NCT01782859|P1|Participant Flow|Placebo|"Control group~Placebo (for Prednisone)"
64759|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV~Prednisone~Hydrocortisone"
64760|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
64962|NCT01781481|O1|Outcome|Pediatric INTERMED Biological Domain Score|Sum of all Pediatric INTERMED Biological domain item scores.
64761|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64762|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
64763|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64764|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
64765|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64766|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
64767|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64768|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
64769|NCT01782859|E2|Reported Event|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
64770|NCT01782859|E1|Reported Event|Placebo|"Control group~Placebo (for Prednisone)"
64771|NCT01782742|B3|Baseline|Total|Total of all reporting groups
64772|NCT01782742|B2|Baseline|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64773|NCT01782742|B1|Baseline|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64774|NCT01782742|P2|Participant Flow|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64775|NCT01782742|P1|Participant Flow|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64776|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64777|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64778|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64779|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64780|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64781|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64782|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64783|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64784|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64785|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64786|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64787|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64788|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64789|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64790|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64791|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64792|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64793|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64794|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64795|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64796|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64797|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64798|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64799|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64800|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64801|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
64802|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64803|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64804|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64805|NCT01782742|E2|Reported Event|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
64806|NCT01782742|E1|Reported Event|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
64807|NCT01782482|B3|Baseline|Total|Total of all reporting groups
64808|NCT01782482|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64809|NCT01782482|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64810|NCT01782482|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64811|NCT01782482|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64812|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64813|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64814|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64815|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64816|NCT01782482|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64817|NCT01782482|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
64818|NCT01782469|B1|Baseline|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64819|NCT01782469|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64820|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64821|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64822|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64823|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64824|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64825|NCT01782469|E1|Reported Event|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
64826|NCT01782326|B3|Baseline|Total|Total of all reporting groups
64827|NCT01782326|B2|Baseline|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64828|NCT01782326|B1|Baseline|QVA149|QVA149 (110/50 μg) once daily
64829|NCT01782326|P2|Participant Flow|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64830|NCT01782326|P1|Participant Flow|QVA149|QVA149 (110/50 μg) once daily
64831|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64832|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
65617|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
64833|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64834|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64835|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64836|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64837|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64838|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64839|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64840|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64841|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64842|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64843|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64844|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64845|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64846|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64847|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64848|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64849|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64850|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64851|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64852|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64853|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64854|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64855|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64856|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64857|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64858|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64859|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64860|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64861|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64862|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64863|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64864|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64865|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64866|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64867|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64868|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64869|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64870|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64871|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64872|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64873|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64874|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64875|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64876|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64877|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64878|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64879|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64880|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64881|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64882|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64883|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64884|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64885|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64886|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
64887|NCT01782326|E2|Reported Event|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
64888|NCT01782326|E1|Reported Event|QVA149|QVA149 (110/50 μg) once daily
64889|NCT01782222|B4|Baseline|Total|Total of all reporting groups
64960|NCT01781481|O3|Outcome|Historical Biological Item: Diagnostic Dilemma|This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
65618|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
64890|NCT01782222|B3|Baseline|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64891|NCT01782222|B2|Baseline|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64892|NCT01782222|B1|Baseline|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64893|NCT01782222|P3|Participant Flow|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64894|NCT01782222|P2|Participant Flow|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64895|NCT01782222|P1|Participant Flow|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64896|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64897|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64898|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64899|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64900|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64901|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64902|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64903|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64904|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64905|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64961|NCT01781481|O2|Outcome|Historical Biological Item: Chronicity|This item taps the extent and chronicity of child's physical health issues.
64906|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64907|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64908|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64909|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64910|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64911|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64912|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64913|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64914|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64915|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64916|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64917|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64918|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64919|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64920|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64921|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64922|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64923|NCT01782222|E3|Reported Event|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64924|NCT01782222|E2|Reported Event|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
64925|NCT01782222|E1|Reported Event|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
64926|NCT01781962|B1|Baseline|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64927|NCT01781962|P1|Participant Flow|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64928|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64929|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64930|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64931|NCT01781962|E1|Reported Event|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
64932|NCT01781481|B1|Baseline|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64933|NCT01781481|P1|Participant Flow|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
64934|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64935|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64936|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64937|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64938|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64939|NCT01781481|O6|Outcome|Vulnerability Health System Item: Health System Impediments|This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
64940|NCT01781481|O5|Outcome|Current Health System Item: Coordination of Care|This item describes the extent to which the different health care providers working with the child are in contact with each other.
64941|NCT01781481|O4|Outcome|Current Health System Item: Organization of Care|This item describes the nature and organization of the health care services that the child is current receiving.
64942|NCT01781481|O3|Outcome|Historical Health System Item: Treatment Experience|This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
64943|NCT01781481|O2|Outcome|Historical Health System Item: Access to Health Care|This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
64944|NCT01781481|O1|Outcome|Pediatric Intermed: Health System Domain Score|Sum of Pediatric INTERMED health system item scores.
64945|NCT01781481|O2|Outcome|CBCL Externalizing Score in the Non-clinical Range|Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
64946|NCT01781481|O1|Outcome|CBCL Externalizing Score in the Clinical Range.|Children whose scores on the CBCL Externalizing scale fell within the clinical range.
64947|NCT01781481|O2|Outcome|CBCL Internalizing Score in the Non-clinical Range|Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
64948|NCT01781481|O1|Outcome|CBCL Internalizing Score in the Clinical Range.|Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
64949|NCT01781481|O2|Outcome|Subjects With CDI Scores in the Non-clinical Range|Children whose scores on the Children's Depression Inventory fell below the clinical range.
64950|NCT01781481|O1|Outcome|Subjects With CDI Scores in the Clinical Range.|Children whose scores on the Children's Depression Inventory fell within the clinical range.
64951|NCT01781481|O2|Outcome|Subjects With MASC Scores in the Non-clinical Range|Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
64952|NCT01781481|O1|Outcome|Subjects With MASC Scores in the Clinical Range.|Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
64953|NCT01781481|O3|Outcome|Pediatric INTERMED Caregiver/Family Domain Score|Sum of Pediatric INTERMED Caregiver/Family Domain item scores
64954|NCT01781481|O2|Outcome|Pediatric INTERMED Social Domain Score|Sum of Pediatric INTERMED Social Domain items scores
64955|NCT01781481|O1|Outcome|Pediatric INTERMED Psychological Domain Score|Sum of Pediatric INTERMED Psychological Domain item scores
64956|NCT01781481|O7|Outcome|Vulnerability Biological Item: Complications and Life Threat|This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
64957|NCT01781481|O6|Outcome|Current Biological Item: Therapeutic Complexity|This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
64958|NCT01781481|O5|Outcome|Current Biological Item: Diagnostic/Therapeutic Challenge|This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
64959|NCT01781481|O4|Outcome|Current Biological Item: Symptom Severity|This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
64963|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64964|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64965|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64966|NCT01781481|O1|Outcome|Children/Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64967|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64968|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64969|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64970|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64971|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64972|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64973|NCT01781481|O4|Outcome|Greater Than 5 Years|Greater than 5 years since initial IBD diagnosis.
64974|NCT01781481|O3|Outcome|1 Year-5 Years|1 - 5 years since initial IBD diagnosis.
64975|NCT01781481|O2|Outcome|6 Months-1 Year|6 months to 1 year since initial IBD diagnosis.
64976|NCT01781481|O1|Outcome|Less Than 6 Months|Less than 6 months since initial IBD diagnosis.
64977|NCT01781481|O4|Outcome|Disease Severity: Severe|Disease Severity classified as severe
64978|NCT01781481|O3|Outcome|Disease Severity: Moderate|Disease Severity classified as moderate
64979|NCT01781481|O2|Outcome|Disease Severity: Mild|Disease Severity classified as mild
64980|NCT01781481|O1|Outcome|Disease Severity: Remission/Inactive|Disease Severity classified as in remission/inactive
64981|NCT01781481|O3|Outcome|Score of 2 or 3|Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
64982|NCT01781481|O2|Outcome|Score of 1|Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
64983|NCT01781481|O1|Outcome|Score of 0|Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
64984|NCT01781481|O5|Outcome|Health Service|Sum of Health Service Domain Item Scores
64985|NCT01781481|O4|Outcome|Family/Caregiver|Sum of Family/Caregiver Domain Item Scores
64986|NCT01781481|O3|Outcome|Social|Sum of Social Domain Item Scores
64987|NCT01781481|O2|Outcome|Psychological|Sum of Psychological Domain Item Scores
64988|NCT01781481|O1|Outcome|Biological|Sum of Biological Domain Item Scores
64989|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64990|NCT01781481|E1|Reported Event|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
64991|NCT01781403|B1|Baseline|Capecitabine, Temozolomide, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
64992|NCT01781403|P3|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 75mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
64993|NCT01781403|P2|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 60mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
64994|NCT01781403|P1|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 45mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
64995|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
64996|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
64997|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
64998|NCT01781403|O2|Outcome|Hypermethylated MGMT|MGMT methylation specific PCR: hypermethylated
64999|NCT01781403|O1|Outcome|Unmethylated MGMT|MGMT methylation specific PCR: unmethlyated
65619|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
105640|NCT01568047|B5|Baseline|Total|Total of all reporting groups
65000|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65001|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65002|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65003|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65004|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65005|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65006|NCT01781403|E3|Reported Event|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65007|NCT01781403|E2|Reported Event|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65008|NCT01781403|E1|Reported Event|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
65009|NCT01781208|B1|Baseline|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
65010|NCT01781208|P1|Participant Flow|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|"62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)~The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues."
65011|NCT01781208|O2|Outcome|Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
65012|NCT01781208|O1|Outcome|Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
65013|NCT01781208|E1|Reported Event|All Participants|No serious or non-serious adverse events were observed during the study.
65014|NCT01781169|B3|Baseline|Total|Total of all reporting groups
65015|NCT01781169|B2|Baseline|Obese Group|
65016|NCT01781169|B1|Baseline|Normal-weight Group|
65017|NCT01781169|P2|Participant Flow|Normal-weight Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
65018|NCT01781169|P1|Participant Flow|Obese Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
65019|NCT01781169|O2|Outcome|Normal-weight Group|Oral supplementation of vitamin D.
65020|NCT01781169|O1|Outcome|Obese Group|Oral supplementation of vitamin D.
65021|NCT01781169|E2|Reported Event|Obese Group|
65022|NCT01781169|E1|Reported Event|Normal-weight Group|
65023|NCT01781026|B1|Baseline|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
65024|NCT01781026|P1|Participant Flow|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
65025|NCT01781026|O1|Outcome|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
65026|NCT01781026|E1|Reported Event|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
65027|NCT01780987|B3|Baseline|Total|Total of all reporting groups
65028|NCT01780987|B2|Baseline|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65029|NCT01780987|B1|Baseline|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65030|NCT01780987|P2|Participant Flow|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65031|NCT01780987|P1|Participant Flow|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65032|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65620|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
65033|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65034|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65035|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65036|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65037|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65038|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65039|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65040|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65041|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65042|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65043|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65044|NCT01780987|E2|Reported Event|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
65045|NCT01780987|E1|Reported Event|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
65046|NCT01780935|B3|Baseline|Total|Total of all reporting groups
65047|NCT01780935|B2|Baseline|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65048|NCT01780935|B1|Baseline|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65049|NCT01780935|P2|Participant Flow|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65050|NCT01780935|P1|Participant Flow|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65051|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65052|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65053|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65054|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65055|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65056|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65057|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65058|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65059|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65060|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65061|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65062|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65063|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65064|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65065|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65066|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65067|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65068|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65069|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65070|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65071|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65072|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65073|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65074|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65075|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65076|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65099|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65077|NCT01780935|E2|Reported Event|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
65078|NCT01780935|E1|Reported Event|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
65079|NCT01780922|B1|Baseline|All Study Participants|All study participants: all participants received all interventions
65080|NCT01780922|P6|Participant Flow|Placebo First, Then CLEB, Then LCJC|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
65081|NCT01780922|P5|Participant Flow|Placebo First, Then LCJC, Then CLEB|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
65082|NCT01780922|P4|Participant Flow|CLEB First, Then Placebo, Then LCJC|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
65083|NCT01780922|P3|Participant Flow|CLEB First, Then LCJC, Then Placebo|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
65084|NCT01780922|P2|Participant Flow|LCJC First, Then Placebo, Then CLEB|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
65085|NCT01780922|P1|Participant Flow|LCJC First, Then CLEB, Then Placebo|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
65086|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65087|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65088|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65089|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65090|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65091|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65092|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65093|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65094|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65095|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65096|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65097|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65098|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65621|NCT01777581|E2|Reported Event|Sugar Pill (Placebo)|Placebo
65100|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65101|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65102|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65103|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65104|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65105|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65106|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65107|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65108|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65109|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65110|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65111|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65112|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65113|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65114|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65115|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65116|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65117|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65118|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65119|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65120|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65121|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65122|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65123|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65124|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65125|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65126|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65190|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65127|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65128|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65129|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65130|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65131|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65132|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65133|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65134|NCT01780922|E3|Reported Event|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65135|NCT01780922|E2|Reported Event|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65136|NCT01780922|E1|Reported Event|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
65137|NCT01780584|B4|Baseline|Total|Total of all reporting groups
65138|NCT01780584|B3|Baseline|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65139|NCT01780584|B2|Baseline|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65140|NCT01780584|B1|Baseline|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65141|NCT01780584|P3|Participant Flow|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65142|NCT01780584|P2|Participant Flow|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65143|NCT01780584|P1|Participant Flow|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65144|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65145|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65146|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65147|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65148|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65149|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65150|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65151|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65152|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65153|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65191|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
107342|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
65154|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65155|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65156|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65157|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65158|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65159|NCT01780584|E3|Reported Event|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
65160|NCT01780584|E2|Reported Event|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
65161|NCT01780584|E1|Reported Event|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
65162|NCT01780506|B3|Baseline|Total|Total of all reporting groups
65163|NCT01780506|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65164|NCT01780506|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65165|NCT01780506|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65166|NCT01780506|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
65167|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65168|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65169|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65170|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65171|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65172|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65173|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65174|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65175|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65176|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65177|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65178|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65179|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65180|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65181|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65182|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65183|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65184|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65185|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65186|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65187|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65188|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65189|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65192|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65193|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65194|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65195|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65196|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65197|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65198|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65199|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65200|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65201|NCT01780506|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
65202|NCT01780506|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
65203|NCT01780389|B1|Baseline|Milnacipran|Open-label flexibly dosed milnacipran
65204|NCT01780389|P1|Participant Flow|Milnacipran|Open-label flexibly dosed milnacipran
65205|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65206|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65207|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65208|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65209|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65210|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65211|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
65212|NCT01780389|O1|Outcome|Milnacipran-Open Label|"Open-label flexibly dosed milnacipran for 12 weeks. Twice-daily dosing will be used and the typical titration schedule will be as follows:~Day 1 - 12.5 mg every morning Day 2-3 - 12.5 mg twice a day Day 4-7 - 25 mg twice a day Day 8-84 - 50 mg twice a day~Taper:~Day 85-88 - 25 mg twice a day Day 89-92 - 12.5 twice a day Day 93-96 - 12.5 mg every morning"
65213|NCT01780389|E1|Reported Event|Milnacipran|Open-label flexibly dosed milnacipran
65214|NCT01780350|B1|Baseline|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
65215|NCT01780350|P1|Participant Flow|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
65216|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
65217|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
65218|NCT01780350|E1|Reported Event|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
65219|NCT01780337|B3|Baseline|Total|Total of all reporting groups
65220|NCT01780337|B2|Baseline|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65221|NCT01780337|B1|Baseline|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65222|NCT01780337|P2|Participant Flow|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65244|NCT01779648|P2|Participant Flow|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~Alternate compression+Adjusted refill time"
65622|NCT01777581|E1|Reported Event|Milnacipran|Milnacipran, flexibly dosed
65623|NCT01777438|B3|Baseline|Total|Total of all reporting groups
65223|NCT01780337|P1|Participant Flow|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65224|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65225|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65226|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65227|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65228|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65229|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65230|NCT01780337|E2|Reported Event|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
65231|NCT01780337|E1|Reported Event|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
65232|NCT01780324|B3|Baseline|Total|Total of all reporting groups
65233|NCT01780324|B2|Baseline|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
65234|NCT01780324|B1|Baseline|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
65235|NCT01780324|P2|Participant Flow|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
65236|NCT01780324|P1|Participant Flow|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
65237|NCT01780324|O2|Outcome|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
65238|NCT01780324|O1|Outcome|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
65239|NCT01780324|E2|Reported Event|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
65240|NCT01780324|E1|Reported Event|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
65241|NCT01779648|B3|Baseline|Total|Total of all reporting groups
65242|NCT01779648|B2|Baseline|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65243|NCT01779648|B1|Baseline|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65245|NCT01779648|P1|Participant Flow|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~Simultaneous compression +Fixed refill time:"
65246|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65247|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65248|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65249|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65250|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65251|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65252|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65253|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65254|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65255|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65256|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65257|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65258|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65259|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65260|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65261|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65262|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65263|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65264|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65265|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65266|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65267|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65268|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65269|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65270|NCT01779648|E2|Reported Event|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
65271|NCT01779648|E1|Reported Event|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
65272|NCT01779219|B3|Baseline|Total|Total of all reporting groups
65273|NCT01779219|B2|Baseline|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65274|NCT01779219|B1|Baseline|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures."
65306|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65275|NCT01779219|P2|Participant Flow|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65276|NCT01779219|P1|Participant Flow|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases."
65277|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65278|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
65279|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65280|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
65281|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65282|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
65307|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65308|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65754|NCT01777217|P2|Participant Flow|Placebo|"Drug: Placebo oral~Placebo"
65283|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65284|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
65285|NCT01779219|E2|Reported Event|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
65286|NCT01779219|E1|Reported Event|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
65287|NCT01778985|B3|Baseline|Total|Total of all reporting groups
65288|NCT01778985|B2|Baseline|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65289|NCT01778985|B1|Baseline|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65290|NCT01778985|P2|Participant Flow|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65291|NCT01778985|P1|Participant Flow|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65292|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65293|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65294|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65295|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65296|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65297|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65298|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65299|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65300|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65301|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65302|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65303|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65304|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65305|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65417|NCT01778062|E2|Reported Event|Placebo|Placebo
65309|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65310|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65311|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65312|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65313|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65314|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65315|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65316|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65317|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65318|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65319|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65320|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65321|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65322|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65323|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65324|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65325|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65326|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65327|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65328|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65329|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65330|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65331|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65332|NCT01778985|E2|Reported Event|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
65333|NCT01778985|E1|Reported Event|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
65334|NCT01778751|B3|Baseline|Total|Total of all reporting groups
65335|NCT01778751|B2|Baseline|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65336|NCT01778751|B1|Baseline|Control|Veterans will receive diabetes educational materials and management per their primary provider
65337|NCT01778751|P2|Participant Flow|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65338|NCT01778751|P1|Participant Flow|Control|Veterans will receive diabetes educational materials and management per their primary provider
65339|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65340|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
65341|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65342|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
65343|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65344|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
65345|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65346|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
65347|NCT01778751|E2|Reported Event|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
65348|NCT01778751|E1|Reported Event|Control|Veterans will receive diabetes educational materials and management per their primary provider
65349|NCT01778530|B1|Baseline|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
65350|NCT01778530|P1|Participant Flow|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
65351|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
65352|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
65353|NCT01778530|E1|Reported Event|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
65354|NCT01778296|B1|Baseline|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
65355|NCT01778296|P1|Participant Flow|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
65356|NCT01778296|O1|Outcome|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
65357|NCT01778296|E1|Reported Event|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
65358|NCT01778127|B4|Baseline|Total|Total of all reporting groups
65359|NCT01778127|B3|Baseline|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65418|NCT01778062|E1|Reported Event|Indacaterol|Indacaterol
65419|NCT01778049|B3|Baseline|Total|Total of all reporting groups
65558|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65360|NCT01778127|B2|Baseline|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65361|NCT01778127|B1|Baseline|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65362|NCT01778127|P3|Participant Flow|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65363|NCT01778127|P2|Participant Flow|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65364|NCT01778127|P1|Participant Flow|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65365|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65366|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65367|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65368|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65420|NCT01778049|B2|Baseline|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
65559|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65369|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65370|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65371|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65372|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65373|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65374|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65375|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65376|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65377|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65421|NCT01778049|B1|Baseline|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
65422|NCT01778049|P6|Participant Flow|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65378|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65379|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65380|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65381|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65382|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65383|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65384|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65385|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65386|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65423|NCT01778049|P5|Participant Flow|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
65424|NCT01778049|P4|Participant Flow|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65425|NCT01778049|P3|Participant Flow|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
65387|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65388|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65389|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65390|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65391|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65392|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65393|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65394|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65395|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65426|NCT01778049|P2|Participant Flow|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
65560|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65396|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65397|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65398|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65399|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65400|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65401|NCT01778127|E3|Reported Event|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65402|NCT01778127|E2|Reported Event|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65403|NCT01778127|E1|Reported Event|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
65404|NCT01778062|B3|Baseline|Total|Total of all reporting groups
65405|NCT01778062|B2|Baseline|Placebo|Placebo once daily
65406|NCT01778062|B1|Baseline|Indacaterol|Indacaterol 150 µg once daily
65407|NCT01778062|P2|Participant Flow|Placebo|Placebo once daily
65408|NCT01778062|P1|Participant Flow|Indacaterol|Indacaterol 150 µg once daily
65409|NCT01778062|O2|Outcome|Placebo|Placebo once daily
65410|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
65411|NCT01778062|O2|Outcome|Placebo|Placebo once daily
65412|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
65413|NCT01778062|O2|Outcome|Placebo|Placebo once daily
65414|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
65415|NCT01778062|O2|Outcome|Placebo|Placebo once daily
65416|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
65427|NCT01778049|P1|Participant Flow|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
65428|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65429|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
65430|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65431|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
65432|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65433|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
65434|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65435|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
65436|NCT01778049|E6|Reported Event|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65437|NCT01778049|E5|Reported Event|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
65438|NCT01778049|E4|Reported Event|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
65439|NCT01778049|E3|Reported Event|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
65440|NCT01778049|E2|Reported Event|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
65441|NCT01778049|E1|Reported Event|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
65442|NCT01778023|B3|Baseline|Total|Total of all reporting groups
65443|NCT01778023|B2|Baseline|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65444|NCT01778023|B1|Baseline|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65445|NCT01778023|P2|Participant Flow|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65446|NCT01778023|P1|Participant Flow|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65447|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65448|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65449|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65450|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65451|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65452|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65453|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65561|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65454|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65455|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65456|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65457|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65458|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65459|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65460|NCT01778023|E2|Reported Event|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65461|NCT01778023|E1|Reported Event|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
65462|NCT01777945|B1|Baseline|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65463|NCT01777945|P1|Participant Flow|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65464|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65465|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65466|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65467|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65468|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65469|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65470|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65471|NCT01777945|E1|Reported Event|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
65472|NCT01777932|B1|Baseline|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65473|NCT01777932|P1|Participant Flow|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65474|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65475|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65476|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65477|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65556|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65608|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
65478|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65479|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65480|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65481|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65482|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65483|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65484|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65485|NCT01777932|E1|Reported Event|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
65486|NCT01777776|B5|Baseline|Total|Total of all reporting groups
65487|NCT01777776|B4|Baseline|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65488|NCT01777776|B3|Baseline|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65489|NCT01777776|B2|Baseline|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65490|NCT01777776|B1|Baseline|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65491|NCT01777776|P4|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65492|NCT01777776|P3|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65493|NCT01777776|P2|Participant Flow|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65494|NCT01777776|P1|Participant Flow|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65495|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65557|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65609|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
107343|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
65496|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65497|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65498|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65499|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65500|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65501|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65502|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65503|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65504|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65505|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65506|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65507|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65508|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65509|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65510|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65511|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65512|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65513|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65514|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65515|NCT01777776|O3|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65516|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65517|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65518|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65519|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65520|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65521|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65522|NCT01777776|O2|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65523|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65524|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65525|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65526|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65527|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65528|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65529|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65530|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65531|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65532|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65533|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65534|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65535|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65536|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65537|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65538|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65539|NCT01777776|O1|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
65540|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65541|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
65542|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65543|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65544|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65545|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65546|NCT01777776|E4|Reported Event|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65547|NCT01777776|E3|Reported Event|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65548|NCT01777776|E2|Reported Event|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65549|NCT01777776|E1|Reported Event|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
65550|NCT01777763|B3|Baseline|Total|Total of all reporting groups
65551|NCT01777763|B2|Baseline|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
65552|NCT01777763|B1|Baseline|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
65553|NCT01777763|P2|Participant Flow|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65554|NCT01777763|P1|Participant Flow|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65555|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65610|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
65562|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65563|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65564|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65565|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65566|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65567|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65568|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65569|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65570|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65571|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65572|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65573|NCT01777763|E2|Reported Event|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
65574|NCT01777763|E1|Reported Event|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
65575|NCT01777620|B3|Baseline|Total|Total of all reporting groups
65576|NCT01777620|B2|Baseline|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65577|NCT01777620|B1|Baseline|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65578|NCT01777620|P2|Participant Flow|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65579|NCT01777620|P1|Participant Flow|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65580|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65581|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65582|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65583|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65584|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65585|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65586|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65587|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65588|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65589|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65590|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65591|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65592|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65593|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65594|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65595|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65596|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65597|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65598|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65599|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65600|NCT01777620|E2|Reported Event|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
65601|NCT01777620|E1|Reported Event|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
65602|NCT01777581|B3|Baseline|Total|Total of all reporting groups
65603|NCT01777581|B2|Baseline|Sugar Pill (Placebo)|Placebo
65604|NCT01777581|B1|Baseline|Milnacipran|Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
65605|NCT01777581|P2|Participant Flow|Sugar Pill (Placebo)|Placebo
65606|NCT01777581|P1|Participant Flow|Milnacipran|Milnacipran, flexibly dosed
65607|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
65624|NCT01777438|B2|Baseline|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65625|NCT01777438|B1|Baseline|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65626|NCT01777438|P2|Participant Flow|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65627|NCT01777438|P1|Participant Flow|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65628|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65629|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65630|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65631|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65632|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65633|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65634|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65635|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65636|NCT01777438|E2|Reported Event|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
65637|NCT01777438|E1|Reported Event|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
65638|NCT01777425|B1|Baseline|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65639|NCT01777425|P1|Participant Flow|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65640|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65641|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65642|NCT01777425|O1|Outcome|Rhinosinusitis Patients and Status|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65643|NCT01777425|E1|Reported Event|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
65644|NCT01777412|B1|Baseline|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65645|NCT01777412|P1|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65646|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65647|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65648|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65649|NCT01777412|E1|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
65650|NCT01777334|B3|Baseline|Total|Total of all reporting groups
65651|NCT01777334|B2|Baseline|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
65652|NCT01777334|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
65653|NCT01777334|P2|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
65654|NCT01777334|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
65655|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
65656|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
65657|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
65755|NCT01777217|P1|Participant Flow|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
65658|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
65659|NCT01777334|E2|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
65660|NCT01777334|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
65661|NCT01777321|B3|Baseline|Total|Total of all reporting groups
65662|NCT01777321|B2|Baseline|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65663|NCT01777321|B1|Baseline|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65664|NCT01777321|P2|Participant Flow|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
65665|NCT01777321|P1|Participant Flow|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
65666|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65667|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65668|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65669|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65670|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65671|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65672|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65673|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65674|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65675|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65676|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65677|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65678|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65679|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65680|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65681|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65682|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65683|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65684|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65685|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65686|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65687|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65688|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65689|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65690|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65691|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65692|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65693|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65694|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65695|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65696|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65697|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65698|NCT01777321|E2|Reported Event|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
65699|NCT01777321|E1|Reported Event|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
65700|NCT01777282|B6|Baseline|Total|Total of all reporting groups
65701|NCT01777282|B5|Baseline|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65702|NCT01777282|B4|Baseline|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65756|NCT01777217|O2|Outcome|Placebo|"Drug: Placebo oral~Placebo"
108229|NCT01556204|B1|Baseline|Robotic|Robotic surgery
65703|NCT01777282|B3|Baseline|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65704|NCT01777282|B2|Baseline|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65705|NCT01777282|B1|Baseline|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65706|NCT01777282|P5|Participant Flow|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65707|NCT01777282|P4|Participant Flow|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65708|NCT01777282|P3|Participant Flow|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65709|NCT01777282|P2|Participant Flow|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65710|NCT01777282|P1|Participant Flow|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65711|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65712|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65713|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65714|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65715|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65716|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65717|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65718|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65719|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65720|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65721|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65722|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65723|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65724|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65725|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65726|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65757|NCT01777217|O1|Outcome|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
65758|NCT01777217|E2|Reported Event|Placebo|"Drug: Placebo oral~Placebo"
65727|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65728|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65729|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65730|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65731|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65732|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65733|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65734|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65735|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65736|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65737|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65738|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65739|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65740|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65741|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65742|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65743|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65744|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65745|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65746|NCT01777282|E5|Reported Event|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65747|NCT01777282|E4|Reported Event|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65748|NCT01777282|E3|Reported Event|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65749|NCT01777282|E2|Reported Event|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65750|NCT01777282|E1|Reported Event|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
65751|NCT01777217|B3|Baseline|Total|Total of all reporting groups
65752|NCT01777217|B2|Baseline|Placebo|"Drug: Placebo oral~Placebo"
65753|NCT01777217|B1|Baseline|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
65759|NCT01777217|E1|Reported Event|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
65760|NCT01777191|B3|Baseline|Total|Total of all reporting groups
65761|NCT01777191|B2|Baseline|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65762|NCT01777191|B1|Baseline|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65763|NCT01777191|P2|Participant Flow|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65764|NCT01777191|P1|Participant Flow|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).
65765|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65766|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65767|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65768|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65769|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65770|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65771|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65772|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65773|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65774|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65775|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65776|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65777|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65778|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65779|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65780|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65781|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65782|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65783|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65784|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65785|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65786|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65787|NCT01777191|E4|Reported Event|Follow Up Period|All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
65788|NCT01777191|E3|Reported Event|80 mg Ixe Prefilled Syringe Optional Safety Extension|One 80 mg Ixekizumab administered as an SC injection Q4W.
65789|NCT01777191|E2|Reported Event|80 mg Ixekizumab Auto-Injector Treatment Period|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65790|NCT01777191|E1|Reported Event|80 mg Ixekizumab Prefilled Syringe Treatment Period|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
65791|NCT01777126|B3|Baseline|Total|Total of all reporting groups
65792|NCT01777126|B2|Baseline|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65793|NCT01777126|B1|Baseline|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65794|NCT01777126|P2|Participant Flow|Oral Nutrition Protocol (ONP) Group|In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65795|NCT01777126|P1|Participant Flow|Control Group|In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65796|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65849|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65797|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65798|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65799|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65800|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65801|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65802|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65803|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65804|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65850|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65851|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65805|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65806|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65807|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65808|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65809|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65810|NCT01777126|O1|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65811|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
65812|NCT01777126|O1|Outcome|Control Group|For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
65852|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65853|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65813|NCT01777126|E2|Reported Event|Enhanced Recovery Oral Nutrition Protocol (ERONP) Group|Subjects enrolled in this arm will undergo the ERONP protocol. An enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
65814|NCT01777126|E1|Reported Event|Control Group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
65815|NCT01776645|B3|Baseline|Total|Total of all reporting groups
65816|NCT01776645|B2|Baseline|Significant Others Group|Significant Others of Participants with Chronic Pain
65817|NCT01776645|B1|Baseline|Compassion Cultivation Training - Participants With Chronic Pa|Compassion Cultivation Training Course - Participants with Chronic Pain
65818|NCT01776645|P2|Participant Flow|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
65819|NCT01776645|P1|Participant Flow|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
65820|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
65821|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
65822|NCT01776645|E2|Reported Event|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
65823|NCT01776645|E1|Reported Event|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
65824|NCT01776554|B3|Baseline|Total|Total of all reporting groups
65825|NCT01776554|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65826|NCT01776554|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65827|NCT01776554|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65828|NCT01776554|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65829|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65830|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65831|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65832|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65833|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65834|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65835|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65836|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65837|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65838|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65839|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65840|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65841|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65842|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65843|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65844|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65845|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65846|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65847|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65848|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65854|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65855|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65856|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65857|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65858|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65859|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65860|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65861|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65862|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65863|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65864|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65865|NCT01776554|E3|Reported Event|Total|Total of subjects in both high dose and low dose groups.
65866|NCT01776554|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65867|NCT01776554|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65868|NCT01776541|B3|Baseline|Total|Total of all reporting groups
65869|NCT01776541|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65870|NCT01776541|B1|Baseline|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65871|NCT01776541|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65872|NCT01776541|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65873|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65874|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65875|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65876|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65877|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65878|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65879|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65880|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65881|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65882|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65883|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65884|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65885|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65886|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
65887|NCT01776541|E3|Reported Event|Total|Total of high dose and low dose groups.
65888|NCT01776541|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65889|NCT01776541|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
65890|NCT01775995|B3|Baseline|Total|Total of all reporting groups
65891|NCT01775995|B2|Baseline|Wait-list Control|Standard of Care Therapy only
65892|NCT01775995|B1|Baseline|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
65893|NCT01775995|P2|Participant Flow|Wait-list Control|"Usual Care~Participants receiving usual care for CLBP and opioid therapy management."
65894|NCT01775995|P1|Participant Flow|Meditation-CBT|"Meditation-CBT + Usual Care~Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management."
65895|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65896|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65897|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65898|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65899|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65900|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65901|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65902|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65903|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65904|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65905|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65906|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65907|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65908|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65909|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65910|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65911|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65912|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65913|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65914|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65915|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65916|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65917|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65918|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65919|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65920|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65921|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65922|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65923|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65924|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65925|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65926|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65927|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65928|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65929|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65930|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65931|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65932|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65933|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65934|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65935|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65936|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65937|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65938|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65939|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65940|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65941|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65942|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65943|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65944|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65945|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65946|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65947|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65948|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65949|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
65950|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
65951|NCT01775995|E2|Reported Event|Wait-list Control|Standard of Care Therapy only
65952|NCT01775995|E1|Reported Event|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
65953|NCT01775852|B3|Baseline|Total|Total of all reporting groups
65954|NCT01775852|B2|Baseline|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65955|NCT01775852|B1|Baseline|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65956|NCT01775852|P2|Participant Flow|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65957|NCT01775852|P1|Participant Flow|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65958|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65959|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65960|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
66031|NCT01774929|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
109237|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
65961|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65962|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65963|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65964|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65965|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65966|NCT01775852|E2|Reported Event|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
65967|NCT01775852|E1|Reported Event|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
65968|NCT01775137|B1|Baseline|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65969|NCT01775137|P1|Participant Flow|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65970|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65971|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65972|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65973|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65974|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
66255|NCT01772550|E2|Reported Event|18 GA Conventional Catheter - Randomized|
65975|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65976|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65977|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65978|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65979|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65980|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65981|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65982|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65983|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65984|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65985|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65986|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65987|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65988|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65989|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65990|NCT01775137|E3|Reported Event|Overall|All participants who inhaled tobramycin inhalation powder during both core and extension study.
65991|NCT01775137|E2|Reported Event|Extension|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T-326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid). The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
65992|NCT01775137|E1|Reported Event|Core|Eligible participants were assigned to four capsules of TIP at 28 mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose = 224 mg tobramycin (112 mg b.i.d.). These 56 days represented 1 cycle of therapy during core study.
65993|NCT01774968|B3|Baseline|Total|Total of all reporting groups
65994|NCT01774968|B2|Baseline|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
65995|NCT01774968|B1|Baseline|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
65996|NCT01774968|P2|Participant Flow|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
65997|NCT01774968|P1|Participant Flow|Human Regular U-500 Insulin TID|Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
65998|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
65999|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66000|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66001|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66002|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66003|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66004|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66005|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66006|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66007|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66008|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66009|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66010|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66011|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66012|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66013|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66014|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66015|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66016|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66017|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66018|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66019|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66020|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66021|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66022|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66023|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66024|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66025|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66026|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66027|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66028|NCT01774968|E2|Reported Event|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
66029|NCT01774968|E1|Reported Event|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
66030|NCT01774929|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
66167|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66032|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
66033|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
66034|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
66035|NCT01774929|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
66036|NCT01774903|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66037|NCT01774903|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66038|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66039|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66040|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66041|NCT01774903|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66042|NCT01774903|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
66043|NCT01774604|B3|Baseline|Total|Total of all reporting groups
66044|NCT01774604|B2|Baseline|Placebo|"Placebo suppositories (#2)~Placebo"
66045|NCT01774604|B1|Baseline|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66046|NCT01774604|P2|Participant Flow|Placebo|"Placebo suppositories (#2)~Placebo"
66047|NCT01774604|P1|Participant Flow|Indomethacin|"Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66048|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66049|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66050|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66051|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66052|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66053|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66054|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66055|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66056|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66057|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66058|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66059|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66060|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
66061|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66062|NCT01774604|E2|Reported Event|Placebo|"Placebo suppositories (#2)~Placebo"
66063|NCT01774604|E1|Reported Event|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
66064|NCT01774305|B3|Baseline|Total|Total of all reporting groups
66065|NCT01774305|B2|Baseline|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
66066|NCT01774305|B1|Baseline|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
66067|NCT01774305|P2|Participant Flow|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
66068|NCT01774305|P1|Participant Flow|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
66069|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
66070|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
66071|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
66072|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
66073|NCT01774305|E2|Reported Event|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
66074|NCT01774305|E1|Reported Event|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
66075|NCT01774253|B1|Baseline|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66076|NCT01774253|P1|Participant Flow|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66369|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66077|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66078|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66079|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66080|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66081|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66082|NCT01774253|E1|Reported Event|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
66083|NCT01774149|B3|Baseline|Total|Total of all reporting groups
66084|NCT01774149|B2|Baseline|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66085|NCT01774149|B1|Baseline|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66086|NCT01774149|P2|Participant Flow|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66087|NCT01774149|P1|Participant Flow|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66088|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66089|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66090|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66091|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66092|NCT01774149|E2|Reported Event|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66093|NCT01774149|E1|Reported Event|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
66094|NCT01774110|B1|Baseline|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
66095|NCT01774110|P1|Participant Flow|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
66096|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
66097|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
66098|NCT01774110|O1|Outcome|ESTT|
66099|NCT01774110|E1|Reported Event|ESTT|early standardized treadmill training
66100|NCT01774084|B3|Baseline|Total|Total of all reporting groups
66101|NCT01774084|B2|Baseline|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66102|NCT01774084|B1|Baseline|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66103|NCT01774084|P2|Participant Flow|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66104|NCT01774084|P1|Participant Flow|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66168|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66105|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66106|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66107|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66108|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66109|NCT01774084|E2|Reported Event|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66110|NCT01774084|E1|Reported Event|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
66111|NCT01774045|B3|Baseline|Total|Total of all reporting groups
66112|NCT01774045|B2|Baseline|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
66113|NCT01774045|B1|Baseline|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
66114|NCT01774045|P2|Participant Flow|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
66115|NCT01774045|P1|Participant Flow|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
66116|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
66117|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66118|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
66119|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66120|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
66121|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66122|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
66123|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66124|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
66125|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66126|NCT01774045|E2|Reported Event|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66127|NCT01774045|E1|Reported Event|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
66128|NCT01773135|B3|Baseline|Total|Total of all reporting groups
66129|NCT01773135|B2|Baseline|Full Term Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered full term (after 37 weeks of gestation)"
66130|NCT01773135|B1|Baseline|Preterm Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered preterm (before 37 weeks of gestation)"
66169|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66170|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66131|NCT01773135|P1|Participant Flow|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
66132|NCT01773135|O2|Outcome|Full Term Group|group of patients who delivered after 37 weeks of gestation
66133|NCT01773135|O1|Outcome|Preterm Group|group of patients who delivered before 37 weeks of gestation
66134|NCT01773135|E1|Reported Event|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
66135|NCT01773122|B5|Baseline|Total|Total of all reporting groups
66136|NCT01773122|B4|Baseline|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
66137|NCT01773122|B3|Baseline|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66138|NCT01773122|B2|Baseline|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66139|NCT01773122|B1|Baseline|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66140|NCT01773122|P4|Participant Flow|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
66141|NCT01773122|P3|Participant Flow|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66142|NCT01773122|P2|Participant Flow|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66143|NCT01773122|P1|Participant Flow|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66144|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
66145|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66146|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66147|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66148|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
66149|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66150|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66151|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66152|NCT01773122|E4|Reported Event|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
66153|NCT01773122|E3|Reported Event|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66154|NCT01773122|E2|Reported Event|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66155|NCT01773122|E1|Reported Event|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
66156|NCT01773889|B1|Baseline|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
66157|NCT01773889|P1|Participant Flow|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
66158|NCT01773889|O1|Outcome|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
66159|NCT01773889|E1|Reported Event|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
66160|NCT01773473|B3|Baseline|Total|Total of all reporting groups
66161|NCT01773473|B2|Baseline|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66162|NCT01773473|B1|Baseline|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66163|NCT01773473|P2|Participant Flow|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66164|NCT01773473|P1|Participant Flow|Insulin Lispro Mix25|Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
66165|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66166|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66171|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66172|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66173|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66174|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66175|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66176|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66177|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66178|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66179|NCT01773473|E2|Reported Event|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
66180|NCT01773473|E1|Reported Event|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
66181|NCT01773291|B4|Baseline|Total|Total of all reporting groups
66182|NCT01773291|B3|Baseline|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
66183|NCT01773291|B2|Baseline|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
66184|NCT01773291|B1|Baseline|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
66185|NCT01773291|P3|Participant Flow|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
66186|NCT01773291|P2|Participant Flow|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
66187|NCT01773291|P1|Participant Flow|Acupuncture|"acupuncture on Shuigou (GV26) and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
66188|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
66189|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
66190|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
66191|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
66192|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
66193|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
66194|NCT01773291|E3|Reported Event|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
66195|NCT01773291|E2|Reported Event|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
66196|NCT01773291|E1|Reported Event|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
66197|NCT01773226|B1|Baseline|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66198|NCT01773226|P1|Participant Flow|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66199|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66200|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66201|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66202|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66203|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66204|NCT01773226|E1|Reported Event|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
66205|NCT01772654|B3|Baseline|Total|Total of all reporting groups
66206|NCT01772654|B2|Baseline|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66254|NCT01772550|E3|Reported Event|20 GA BD Nexiva Diffusics - Nonrandomized|
66207|NCT01772654|B1|Baseline|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66208|NCT01772654|P2|Participant Flow|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66209|NCT01772654|P1|Participant Flow|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66210|NCT01772654|O2|Outcome|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood. This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66211|NCT01772654|O1|Outcome|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66212|NCT01772654|E2|Reported Event|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66213|NCT01772654|E1|Reported Event|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
66214|NCT01772550|B4|Baseline|Total|Total of all reporting groups
66215|NCT01772550|B3|Baseline|20 GA BD Nexiva Diffusics - Nonrandomized|
66216|NCT01772550|B2|Baseline|18 GA Conventional Catheter - Randomized|
66217|NCT01772550|B1|Baseline|20 GA BD Nexiva Diffusics - Randomized|
66218|NCT01772550|P3|Participant Flow|20 GA BD Nexiva Diffusics - Nonrandomized|Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
66219|NCT01772550|P2|Participant Flow|18 GA Conventional Catheter - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter
66220|NCT01772550|P1|Participant Flow|20 GA BD Nexiva Diffusics - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter
66221|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66222|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66223|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66224|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66225|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66226|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66227|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66228|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66229|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66230|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66231|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66232|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66233|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66234|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66235|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66236|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66237|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66238|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66239|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66240|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66241|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66242|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66243|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66244|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66245|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66246|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66247|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66248|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66249|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66250|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66251|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
66252|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
66253|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
66256|NCT01772550|E1|Reported Event|20 GA BD Nexiva Diffusics - Randomized|
66257|NCT01772316|B1|Baseline|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66258|NCT01772316|P1|Participant Flow|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by subcutaneous (SC) injection and as a single fixed dose irrespective of body weight.
66259|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66260|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66261|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66262|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66263|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66264|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66265|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66266|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66267|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66268|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66269|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66270|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66271|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66272|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66273|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66274|NCT01772316|E1|Reported Event|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
66275|NCT01772147|B4|Baseline|Total|Total of all reporting groups
66276|NCT01772147|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66277|NCT01772147|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66278|NCT01772147|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66370|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66279|NCT01772147|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66280|NCT01772147|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66281|NCT01772147|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and FSC 250/50 µg twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66282|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66283|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66284|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66285|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66286|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66287|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66288|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66289|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66290|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66291|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66292|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66293|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66294|NCT01772147|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66295|NCT01772147|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66296|NCT01772147|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66297|NCT01772134|B4|Baseline|Total|Total of all reporting groups
66298|NCT01772134|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66299|NCT01772134|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66300|NCT01772134|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66301|NCT01772134|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66302|NCT01772134|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66303|NCT01772134|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg) twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66304|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66305|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66306|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66307|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66308|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66309|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66310|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66311|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66312|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66313|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66314|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66315|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66316|NCT01772134|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66317|NCT01772134|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66318|NCT01772134|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
66319|NCT01771991|B3|Baseline|Total|Total of all reporting groups
66320|NCT01771991|B2|Baseline|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
66321|NCT01771991|B1|Baseline|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
66322|NCT01771991|P2|Participant Flow|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
66323|NCT01771991|P1|Participant Flow|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
66324|NCT01771991|O2|Outcome|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
66325|NCT01771991|O1|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
66326|NCT01771991|E2|Reported Event|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
66327|NCT01771991|E1|Reported Event|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
66328|NCT01771913|B3|Baseline|Total|Total of all reporting groups
66329|NCT01771913|B2|Baseline|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66330|NCT01771913|B1|Baseline|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66331|NCT01771913|P2|Participant Flow|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66332|NCT01771913|P1|Participant Flow|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66371|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66372|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66373|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66333|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66334|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66335|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66336|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66337|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66338|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66339|NCT01771913|E2|Reported Event|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
66340|NCT01771913|E1|Reported Event|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
66341|NCT01771172|B1|Baseline|Acute Defibrillation Testing|
66342|NCT01771172|P1|Participant Flow|Acute Defibrillation Testing|
66343|NCT01771172|O1|Outcome|Acute Defibrillation Testing|
66344|NCT01771172|E1|Reported Event|Acute Defibrillation Testing|
66345|NCT01770860|B1|Baseline|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
66346|NCT01770860|P1|Participant Flow|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
66347|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66348|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66349|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66350|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66351|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66352|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66353|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66354|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66355|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66356|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66357|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66358|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66359|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66360|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66361|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66362|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66363|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66364|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66365|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66366|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66367|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66368|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66376|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66377|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66378|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66379|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66380|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66381|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66382|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
66383|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
66384|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
66385|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
66386|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
66387|NCT01770860|E1|Reported Event|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
66388|NCT01770743|B6|Baseline|Total|Total of all reporting groups
66389|NCT01770743|B5|Baseline|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66390|NCT01770743|B4|Baseline|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66391|NCT01770743|B3|Baseline|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66392|NCT01770743|B2|Baseline|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66393|NCT01770743|B1|Baseline|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66394|NCT01770743|P5|Participant Flow|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66395|NCT01770743|P4|Participant Flow|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66396|NCT01770743|P3|Participant Flow|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66397|NCT01770743|P2|Participant Flow|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66398|NCT01770743|P1|Participant Flow|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66399|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66400|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66401|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66402|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66403|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66404|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66405|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66406|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66407|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66408|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66409|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66410|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66411|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66412|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66413|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66414|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66415|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66416|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66417|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66589|NCT01769586|O2|Outcome|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
66418|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66419|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66420|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66421|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66422|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66423|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66424|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66425|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66426|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66427|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66428|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66429|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66430|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66431|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66432|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66433|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66434|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66435|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66436|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66437|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66438|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66439|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66440|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66441|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66442|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66443|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66444|NCT01770743|E5|Reported Event|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
66445|NCT01770743|E4|Reported Event|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66446|NCT01770743|E3|Reported Event|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66447|NCT01770743|E2|Reported Event|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66448|NCT01770743|E1|Reported Event|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
66449|NCT01770691|B1|Baseline|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
66450|NCT01770691|P1|Participant Flow|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
66451|NCT01770691|O4|Outcome|Cleared TIPI Device (G3)|7 subjects used the cleared TIPI G3 for up to 8 hours
66452|NCT01770691|O3|Outcome|SMD 9|7 subjects used SMD 9 for up to 8 hours
66453|NCT01770691|O2|Outcome|SMD 12 2009|6 subjects used SMD 12 for up to 8 hours during 2009
66454|NCT01770691|O1|Outcome|SMD 12 2008|5 subjects used SMD 12 for up to 8 hours during 2008
66455|NCT01770691|E1|Reported Event|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
66456|NCT01770652|B5|Baseline|Total|Total of all reporting groups
109238|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
66457|NCT01770652|B4|Baseline|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66458|NCT01770652|B3|Baseline|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66459|NCT01770652|B2|Baseline|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66460|NCT01770652|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66461|NCT01770652|P4|Participant Flow|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66462|NCT01770652|P3|Participant Flow|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66463|NCT01770652|P2|Participant Flow|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66464|NCT01770652|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66465|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66466|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66467|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66468|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66469|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66470|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66471|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66472|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66473|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66474|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66475|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66476|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66477|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66478|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66479|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66480|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66481|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66482|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66483|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66484|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66485|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66486|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66487|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66488|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
66489|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66490|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66491|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66492|NCT01770652|O1|Outcome|Normal Renal Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66493|NCT01770652|E4|Reported Event|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66494|NCT01770652|E3|Reported Event|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66495|NCT01770652|E2|Reported Event|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66496|NCT01770652|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
66497|NCT01770509|B3|Baseline|Total|Total of all reporting groups
66498|NCT01770509|B2|Baseline|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66499|NCT01770509|B1|Baseline|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66500|NCT01770509|P2|Participant Flow|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66501|NCT01770509|P1|Participant Flow|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66502|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66503|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66504|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66505|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66506|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66507|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66508|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66509|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66510|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66511|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66512|NCT01770509|E2|Reported Event|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
66513|NCT01770509|E1|Reported Event|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
66514|NCT01770483|B3|Baseline|Total|Total of all reporting groups
66515|NCT01770483|B2|Baseline|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66516|NCT01770483|B1|Baseline|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66590|NCT01769586|O1|Outcome|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
66517|NCT01770483|P2|Participant Flow|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66518|NCT01770483|P1|Participant Flow|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66519|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66520|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66521|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66522|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66523|NCT01770483|E2|Reported Event|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66524|NCT01770483|E1|Reported Event|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
66525|NCT01770392|B1|Baseline|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
66526|NCT01770392|P1|Participant Flow|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
66527|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
66528|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
66529|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg Rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
66530|NCT01770392|O1|Outcome|Nintedanib|150 mg of Nintedanib was given as a single dose on Day 1.
66531|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
66532|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
66533|NCT01770392|E4|Reported Event|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
66534|NCT01770392|E3|Reported Event|Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1
66535|NCT01770392|E2|Reported Event|Washout Period|washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
66536|NCT01770392|E1|Reported Event|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
66537|NCT01770379|B4|Baseline|Total|Total of all reporting groups
66538|NCT01770379|B3|Baseline|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66539|NCT01770379|B2|Baseline|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66540|NCT01770379|B1|Baseline|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66541|NCT01770379|P3|Participant Flow|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66542|NCT01770379|P2|Participant Flow|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66543|NCT01770379|P1|Participant Flow|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66544|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
109239|NCT01548287|O4|Outcome|Placebo|Placebo daily
66545|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66546|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66547|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66548|NCT01770379|O2|Outcome|AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66549|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status
66550|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66551|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66552|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66553|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66554|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66555|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66556|NCT01770379|E3|Reported Event|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
66557|NCT01770379|E2|Reported Event|Any AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
66558|NCT01770379|E1|Reported Event|Any AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
66559|NCT01770366|B3|Baseline|Total|Total of all reporting groups
66560|NCT01770366|B2|Baseline|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
66561|NCT01770366|B1|Baseline|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
66562|NCT01770366|P2|Participant Flow|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
66563|NCT01770366|P1|Participant Flow|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
66564|NCT01770366|O2|Outcome|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
66565|NCT01770366|O1|Outcome|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
66566|NCT01770366|E2|Reported Event|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
66567|NCT01770366|E1|Reported Event|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
66568|NCT01770314|B3|Baseline|Total|Total of all reporting groups
66569|NCT01770314|B2|Baseline|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
66570|NCT01770314|B1|Baseline|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
66571|NCT01770314|P2|Participant Flow|Experimental|Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
66572|NCT01770314|P1|Participant Flow|Control|The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.
66573|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
66574|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
66575|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
66576|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
66577|NCT01770314|E2|Reported Event|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
66578|NCT01770314|E1|Reported Event|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
66579|NCT01770145|B1|Baseline|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
66580|NCT01770145|P1|Participant Flow|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
66581|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmet Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
66582|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
66583|NCT01770145|E1|Reported Event|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
66584|NCT01769586|B3|Baseline|Total|Total of all reporting groups
66585|NCT01769586|B2|Baseline|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
66586|NCT01769586|B1|Baseline|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
66587|NCT01769586|P2|Participant Flow|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
66588|NCT01769586|P1|Participant Flow|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
66591|NCT01769586|E2|Reported Event|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
66592|NCT01769586|E1|Reported Event|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
66593|NCT01769508|B1|Baseline|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66594|NCT01769508|P1|Participant Flow|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66595|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66596|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66597|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66598|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66599|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66600|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66601|NCT01769508|E1|Reported Event|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
66602|NCT01769443|B3|Baseline|Total|Total of all reporting groups
66603|NCT01769443|B2|Baseline|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66604|NCT01769443|B1|Baseline|No Desensitization|No desensitization therapy pre-transplantation
66605|NCT01769443|P2|Participant Flow|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66606|NCT01769443|P1|Participant Flow|No Desensitization|No desensitization therapy pre-transplantation
66607|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66608|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66663|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
66609|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66610|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66611|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66612|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66613|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66614|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66615|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66616|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66617|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66618|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66619|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66620|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66621|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66622|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66623|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66624|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
67633|NCT01764945|E8|Reported Event|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3.
66625|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66626|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66627|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66628|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66629|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66630|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66631|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66632|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66633|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66634|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66635|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66636|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66637|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66638|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66639|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66640|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
67634|NCT01764945|E7|Reported Event|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2.
66641|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66642|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66643|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66644|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
66645|NCT01769443|E2|Reported Event|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
66646|NCT01769443|E1|Reported Event|No Desensitization|No desensitization therapy pre-transplantation
66647|NCT01769391|B3|Baseline|Total|Total of all reporting groups
66648|NCT01769391|B2|Baseline|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
66649|NCT01769391|B1|Baseline|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66650|NCT01769391|P2|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
66651|NCT01769391|P1|Participant Flow|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66652|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66653|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
66654|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66655|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
66656|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66657|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
66658|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66659|NCT01769391|O1|Outcome|Necitumumab + Paclitaxel+ Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
66660|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
66661|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
66662|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
66664|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
66665|NCT01769391|E2|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
66666|NCT01769391|E1|Reported Event|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
66667|NCT01769378|B3|Baseline|Total|Total of all reporting groups
66668|NCT01769378|B2|Baseline|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66669|NCT01769378|B1|Baseline|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66670|NCT01769378|P2|Participant Flow|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66671|NCT01769378|P1|Participant Flow|Dulaglutide|Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66672|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66673|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66674|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66675|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66676|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66677|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66678|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66679|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66680|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66681|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66682|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66683|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66684|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66685|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66686|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66687|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66688|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66689|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66690|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66691|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66692|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66693|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66694|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66695|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66696|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66697|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66698|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66699|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66700|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66701|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66702|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66703|NCT01769378|E2|Reported Event|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66704|NCT01769378|E1|Reported Event|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
66705|NCT01769365|B4|Baseline|Total|Total of all reporting groups
66706|NCT01769365|B3|Baseline|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
66707|NCT01769365|B2|Baseline|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
66708|NCT01769365|B1|Baseline|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
66709|NCT01769365|P3|Participant Flow|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
66710|NCT01769365|P2|Participant Flow|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
66711|NCT01769365|P1|Participant Flow|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
66712|NCT01769365|O3|Outcome|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
66713|NCT01769365|O2|Outcome|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
66714|NCT01769365|O1|Outcome|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
66715|NCT01769365|E3|Reported Event|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
66716|NCT01769365|E2|Reported Event|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
66717|NCT01769365|E1|Reported Event|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
66718|NCT01769339|B1|Baseline|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66719|NCT01769339|P1|Participant Flow|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
66720|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66721|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66722|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66723|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66724|NCT01769339|E1|Reported Event|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
66725|NCT01769248|B3|Baseline|Total|Total of all reporting groups
66726|NCT01769248|B2|Baseline|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
66727|NCT01769248|B1|Baseline|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
66728|NCT01769248|P2|Participant Flow|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB, test arm for core biopsies, EUS-FNB"
67635|NCT01764945|E6|Reported Event|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1.
66729|NCT01769248|P1|Participant Flow|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration using EUS-FNA needles. This was the standard of care arm"
66730|NCT01769248|O2|Outcome|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
66731|NCT01769248|O1|Outcome|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
66732|NCT01769248|E2|Reported Event|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
66733|NCT01769248|E1|Reported Event|Fine Needle Aspiration|Fine needle aspiration: Fine needle aspiration
66734|NCT01769105|B3|Baseline|Total|Total of all reporting groups
66735|NCT01769105|B2|Baseline|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66736|NCT01769105|B1|Baseline|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment"
66737|NCT01769105|P2|Participant Flow|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66738|NCT01769105|P1|Participant Flow|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment"
66739|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
66740|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66741|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
66742|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
66743|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66744|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
66745|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
66746|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66747|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
66748|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
66749|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66750|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
66751|NCT01769105|O3|Outcome|Cross-over Lipiflow|patients received a single Lipiflow treatment after performing lid hygiene for 3 month
66752|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66753|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
66754|NCT01769105|E2|Reported Event|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
66755|NCT01769105|E1|Reported Event|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily first and then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow-treatment"
66756|NCT01768676|B3|Baseline|Total|Total of all reporting groups
66757|NCT01768676|B2|Baseline|Placebo|placebo taken once daily in the evening
66758|NCT01768676|B1|Baseline|Avanafil|100 mg once daily in the evening
66759|NCT01768676|P2|Participant Flow|Placebo|placebo taken once daily in the evening
66760|NCT01768676|P1|Participant Flow|Avanafil|100 mg once daily in the evening
66761|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
66762|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
66763|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
66764|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
66765|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
66766|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
66767|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
66768|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
66769|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
66770|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
66771|NCT01768676|E2|Reported Event|Placebo|placebo taken once daily in the evening
66772|NCT01768676|E1|Reported Event|Avanafil|100 mg once daily in the evening
66773|NCT01768559|B4|Baseline|Total|Total of all reporting groups
66774|NCT01768559|B3|Baseline|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
66775|NCT01768559|B2|Baseline|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
66776|NCT01768559|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66777|NCT01768559|P3|Participant Flow|Insulin Glulisine TID|Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.
66778|NCT01768559|P2|Participant Flow|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
66779|NCT01768559|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66780|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
66781|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
66782|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66783|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66784|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66785|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66786|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66787|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66788|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66789|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66790|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66791|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66792|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66793|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66794|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66795|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66796|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66797|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66798|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66799|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66800|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66801|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66802|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66803|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66804|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66805|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66806|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66807|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66808|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66809|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66810|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66811|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66812|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66813|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66814|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66815|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66816|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66817|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
66818|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66819|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66820|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
109240|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
66821|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
66822|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
66823|NCT01768559|E3|Reported Event|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
66824|NCT01768559|E2|Reported Event|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
66825|NCT01768559|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).
66826|NCT01768325|B3|Baseline|Total|Total of all reporting groups
66827|NCT01768325|B2|Baseline|ProCore Needle|
66828|NCT01768325|B1|Baseline|QuickCore Needle|
66829|NCT01768325|P2|Participant Flow|ProCore Needle|
66830|NCT01768325|P1|Participant Flow|Quick Core Needle|
66831|NCT01768325|O2|Outcome|ProCore Needle|
66832|NCT01768325|O1|Outcome|Quick Core Needle|
66833|NCT01768325|O2|Outcome|ProCore Needle|
66834|NCT01768325|O1|Outcome|Quick Core Needle|
66835|NCT01768325|O2|Outcome|ProCore Needle|"Core biopsy needle comparison to obtain diagnostic yield.~Cook Medical core biopsy needle: Obtaining a larger specimen."
66836|NCT01768325|O1|Outcome|Quick Core Needle|"Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle~Cook Medical core biopsy needle: Obtaining a larger specimen."
66837|NCT01768325|E2|Reported Event|ProCore Needle|
66838|NCT01768325|E1|Reported Event|Quick Core Needle|
66839|NCT01768286|B5|Baseline|Total|Total of all reporting groups
66840|NCT01768286|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66841|NCT01768286|B3|Baseline|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66842|NCT01768286|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66843|NCT01768286|B1|Baseline|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66844|NCT01768286|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66845|NCT01768286|P3|Participant Flow|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66846|NCT01768286|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
66847|NCT01768286|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
66848|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66849|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66850|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66851|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66852|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66853|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66854|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66855|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66856|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66857|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66858|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66859|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66860|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66861|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66862|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66863|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66864|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66865|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66866|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66867|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66868|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66869|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66870|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66871|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66872|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66873|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
68952|NCT01762345|P1|Participant Flow|Pessary Device|pessary (disposable intra-vaginal device)
66874|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66875|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66876|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66877|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66878|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66879|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66880|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66881|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66882|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66883|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66884|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66885|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66886|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66887|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66888|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66889|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66890|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66891|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66892|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66893|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66894|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66895|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66896|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66897|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66898|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66899|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66900|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66901|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66902|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66903|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66904|NCT01768286|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
66905|NCT01768286|E3|Reported Event|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
66906|NCT01768286|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
66907|NCT01768286|E1|Reported Event|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
66908|NCT01768117|B1|Baseline|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66909|NCT01768117|P1|Participant Flow|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66910|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66911|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66912|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66913|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66914|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66915|NCT01768117|E1|Reported Event|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
66916|NCT01768013|B1|Baseline|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66917|NCT01768013|P1|Participant Flow|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66918|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66952|NCT01768000|P2|Participant Flow|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66919|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66920|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66921|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66922|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66923|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66924|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66925|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66926|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66927|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66928|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66929|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66930|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66931|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66932|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66933|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66934|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66935|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66992|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
109241|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
66936|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66937|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66938|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66939|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66940|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66941|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66942|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66943|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66944|NCT01768013|E1|Reported Event|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
66945|NCT01768000|B5|Baseline|Total|Total of all reporting groups
66946|NCT01768000|B4|Baseline|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66947|NCT01768000|B3|Baseline|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66948|NCT01768000|B2|Baseline|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66949|NCT01768000|B1|Baseline|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66950|NCT01768000|P4|Participant Flow|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66951|NCT01768000|P3|Participant Flow|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66953|NCT01768000|P1|Participant Flow|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66954|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66955|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66956|NCT01768000|O2|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66957|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66958|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66959|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66960|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66961|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66962|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66963|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66964|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66993|NCT01767987|E2|Reported Event|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
67147|NCT01766921|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.
66965|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66966|NCT01768000|E4|Reported Event|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66967|NCT01768000|E3|Reported Event|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66968|NCT01768000|E2|Reported Event|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
66969|NCT01768000|E1|Reported Event|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
66970|NCT01767987|B3|Baseline|Total|Total of all reporting groups
66971|NCT01767987|B2|Baseline|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66972|NCT01767987|B1|Baseline|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66973|NCT01767987|P2|Participant Flow|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66974|NCT01767987|P1|Participant Flow|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66975|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66976|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66977|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66978|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66979|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66980|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66981|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66982|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66983|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66984|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66985|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66986|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66987|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66988|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66989|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
66990|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66991|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
67099|NCT01767103|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
66994|NCT01767987|E1|Reported Event|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
66995|NCT01767688|B3|Baseline|Total|Total of all reporting groups
66996|NCT01767688|B2|Baseline|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
66997|NCT01767688|B1|Baseline|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
66998|NCT01767688|P2|Participant Flow|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
66999|NCT01767688|P1|Participant Flow|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67000|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67001|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67002|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67003|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67004|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67005|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67006|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67007|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67008|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67009|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67010|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67011|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67012|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67013|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67014|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67015|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67016|NCT01767688|E2|Reported Event|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
67017|NCT01767688|E1|Reported Event|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
67018|NCT01767597|B3|Baseline|Total|Total of all reporting groups
67019|NCT01767597|B2|Baseline|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
67020|NCT01767597|B1|Baseline|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
67021|NCT01767597|P2|Participant Flow|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
67145|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67022|NCT01767597|P1|Participant Flow|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
67023|NCT01767597|O2|Outcome|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
67024|NCT01767597|O1|Outcome|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
67025|NCT01767597|E2|Reported Event|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
67026|NCT01767597|E1|Reported Event|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
67027|NCT01767519|B4|Baseline|Total|Total of all reporting groups
67028|NCT01767519|B3|Baseline|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67029|NCT01767519|B2|Baseline|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67030|NCT01767519|B1|Baseline|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67031|NCT01767519|P3|Participant Flow|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67032|NCT01767519|P2|Participant Flow|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67033|NCT01767519|P1|Participant Flow|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67034|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67035|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67036|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67037|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67038|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67039|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67040|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67041|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67042|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67043|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67044|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67045|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67146|NCT01766921|E3|Reported Event|Total|Total of subjects in both high and low dose groups.
67046|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67047|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67048|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67049|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67050|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67051|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67052|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67053|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67054|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67055|NCT01767519|E3|Reported Event|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67056|NCT01767519|E2|Reported Event|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
67057|NCT01767519|E1|Reported Event|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
67058|NCT01767285|B3|Baseline|Total|Total of all reporting groups
67059|NCT01767285|B2|Baseline|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67060|NCT01767285|B1|Baseline|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67061|NCT01767285|P2|Participant Flow|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67062|NCT01767285|P1|Participant Flow|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67063|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67064|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67065|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67066|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67067|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67068|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67069|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67070|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67071|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67072|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67073|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67074|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67075|NCT01767285|E2|Reported Event|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67076|NCT01767285|E1|Reported Event|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
67077|NCT01767116|B3|Baseline|Total|Total of all reporting groups
67078|NCT01767116|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67079|NCT01767116|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67080|NCT01767116|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67081|NCT01767116|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67082|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67083|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67084|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67085|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67086|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67087|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67088|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67089|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67090|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67091|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67092|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67093|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67094|NCT01767116|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
67095|NCT01767116|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
67096|NCT01767103|B4|Baseline|Total|Total of all reporting groups
67097|NCT01767103|B3|Baseline|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
67098|NCT01767103|B2|Baseline|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
109242|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
67100|NCT01767103|P3|Participant Flow|Moderate Hepatic Failure|Moderate hepatic impairment as defined by Child-Pugh Class : 7-9 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
67101|NCT01767103|P2|Participant Flow|Mild Hepatic Failure|Mild hepatic impairment as defined by Child-Pugh Class C: 5-6 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
67102|NCT01767103|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function. All subjects received a single 33 mg/kg oral dose of deferiprone.
67103|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67104|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67105|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67106|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67107|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67108|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67109|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67110|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67111|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67112|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67113|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67114|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67115|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
67116|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67117|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67118|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67119|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67120|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67121|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67122|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
67123|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67124|NCT01767103|E3|Reported Event|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
67125|NCT01767103|E2|Reported Event|Mild Hepatic Failure|Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
67126|NCT01767103|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
67127|NCT01766921|B3|Baseline|Total|Total of all reporting groups
67128|NCT01766921|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67129|NCT01766921|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67130|NCT01766921|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67131|NCT01766921|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67132|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67133|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67134|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67135|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67136|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67137|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67138|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67139|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67140|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67141|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67142|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67143|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67144|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
67148|NCT01766921|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
67149|NCT01766713|B3|Baseline|Total|Total of all reporting groups
67150|NCT01766713|B2|Baseline|Placebo|Placebo only
67151|NCT01766713|B1|Baseline|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
67152|NCT01766713|P2|Participant Flow|Placebo|Placebo
67153|NCT01766713|P1|Participant Flow|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
67154|NCT01766713|O2|Outcome|Placebo|Placebo
67155|NCT01766713|O1|Outcome|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
67156|NCT01766713|E2|Reported Event|Placebo|
67157|NCT01766713|E1|Reported Event|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
67158|NCT01766466|B3|Baseline|Total|Total of all reporting groups
67159|NCT01766466|B2|Baseline|ITT Population - Ticagrelor 7 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior."
67160|NCT01766466|B1|Baseline|ITT Population - Ticagrelor 6 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior."
67161|NCT01766466|P4|Participant Flow|Day 5 - Ticagrelor (90mg) Dosing (7 Doses)|Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
67162|NCT01766466|P3|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.
67163|NCT01766466|P2|Participant Flow|Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)|Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.
67164|NCT01766466|P1|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.
67165|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
67166|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
67167|NCT01766466|O1|Outcome|All Patients|
67168|NCT01766466|O3|Outcome|Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion|
67169|NCT01766466|O2|Outcome|Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion|
67170|NCT01766466|O1|Outcome|All Patients|
67171|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
67172|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
67173|NCT01766466|O1|Outcome|All Patients|
67174|NCT01766466|E2|Reported Event|Cangrelor + Ticagrelor 90mg (7 Doses)|Ticagrelor discontinued 12 h prior to cangrelor infusion
67175|NCT01766466|E1|Reported Event|Cangrelor + Ticagrelor 90mg (6 Doses)|Ticagrelor was discontinued 24 h prior to cangrelor infusion
67176|NCT01766336|B3|Baseline|Total|Total of all reporting groups
67177|NCT01766336|B2|Baseline|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
67178|NCT01766336|B1|Baseline|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
67179|NCT01766336|P2|Participant Flow|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
67180|NCT01766336|P1|Participant Flow|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
67181|NCT01766336|O2|Outcome|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
67182|NCT01766336|O1|Outcome|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
67183|NCT01766336|E2|Reported Event|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
67184|NCT01766336|E1|Reported Event|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
67185|NCT01766310|B3|Baseline|Total|Total of all reporting groups
67186|NCT01766310|B2|Baseline|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
67187|NCT01766310|B1|Baseline|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
67188|NCT01766310|P2|Participant Flow|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
67189|NCT01766310|P1|Participant Flow|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
67190|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
67191|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
67192|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
67193|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
67194|NCT01766310|E2|Reported Event|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
67195|NCT01766310|E1|Reported Event|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
67196|NCT01766076|B3|Baseline|Total|Total of all reporting groups
67197|NCT01766076|B2|Baseline|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
67198|NCT01766076|B1|Baseline|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC will be collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
67199|NCT01766076|P2|Participant Flow|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
67200|NCT01766076|P1|Participant Flow|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry"
67201|NCT01766076|O2|Outcome|Placebo|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
67202|NCT01766076|O1|Outcome|Atorvastatin|"Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
67203|NCT01766076|E2|Reported Event|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
67204|NCT01766076|E1|Reported Event|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry"
67205|NCT01766050|B1|Baseline|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67206|NCT01766050|P1|Participant Flow|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67207|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
67208|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
67209|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67210|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67211|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67212|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67213|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67214|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67215|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67216|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67217|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67218|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67219|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
109243|NCT01548287|O4|Outcome|Placebo|Placebo daily
67220|NCT01766050|O5|Outcome|All Participants|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67221|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67222|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67223|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67224|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67225|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67226|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67227|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67228|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67229|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67230|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67231|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67232|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67233|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67234|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67235|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67236|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67237|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67238|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67239|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered on Day 4.
67240|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day1.
67241|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67242|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67243|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67244|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67245|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day11.
67246|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67247|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67248|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 1.
67249|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67250|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67251|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67252|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67253|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67254|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67255|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67256|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67257|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1, 4, 7 and 11.
67258|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67259|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67260|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67261|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67262|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67263|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67264|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67265|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67266|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67267|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67268|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67269|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67270|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67271|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67272|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67273|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67274|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67275|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67276|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67277|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67278|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67279|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67280|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67281|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67282|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67283|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67284|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67285|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67286|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67287|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67288|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67289|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67290|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67291|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
68953|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
67292|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67293|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67294|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67295|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
67296|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67297|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67298|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67299|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67300|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67301|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67302|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67303|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67304|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67305|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67306|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67307|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67308|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67309|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67310|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67311|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67312|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67313|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67314|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67315|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67316|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67317|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67318|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67319|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67320|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67321|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67322|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67323|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67324|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67325|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67326|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67327|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67328|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67329|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67330|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67331|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67332|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67333|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
67334|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
67335|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
67336|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
67337|NCT01766050|E1|Reported Event|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
67338|NCT01766037|B3|Baseline|Total|Total of all reporting groups
67339|NCT01766037|B2|Baseline|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67340|NCT01766037|B1|Baseline|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67341|NCT01766037|P2|Participant Flow|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67342|NCT01766037|P1|Participant Flow|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67343|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67344|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67345|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67346|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67347|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67348|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67349|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67350|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67351|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67352|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67353|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67354|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67355|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67356|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67357|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67358|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67359|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67360|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67361|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67362|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67363|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67364|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67365|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67366|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67367|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67368|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67369|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67370|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67371|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67372|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67373|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67374|NCT01766037|E2|Reported Event|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67375|NCT01766037|E1|Reported Event|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
67376|NCT01766024|B3|Baseline|Total|Total of all reporting groups
67377|NCT01766024|B2|Baseline|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
67378|NCT01766024|B1|Baseline|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
67379|NCT01766024|P2|Participant Flow|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
67380|NCT01766024|P1|Participant Flow|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
67381|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
67382|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
67383|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif (interferon beta-1a) a
67384|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033 (interferon beta-1a)
67385|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
67386|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
67387|NCT01766024|E2|Reported Event|Rebif|the endpoint was assessed in all the volunteer who received Rebif
67388|NCT01766024|E1|Reported Event|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
67389|NCT01765972|B1|Baseline|Overall|All subjects that were dispensed a study lens.
67390|NCT01765972|P4|Participant Flow|Spectacle/ Test 2/ Test 1/ Test 3|Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
67391|NCT01765972|P3|Participant Flow|Test 3/ Test 1/ Test 2/ Spectacle|Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
67392|NCT01765972|P2|Participant Flow|Test 2/ Test 3/ Spectacle/ Test 1|Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
67393|NCT01765972|P1|Participant Flow|Test 1/Spectacle/Test 2/ Test 3|Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
67394|NCT01765972|O4|Outcome|Spectacle|Subjects that wore spectacles in any of the 4 periods of this study.
67395|NCT01765972|O3|Outcome|Test 3 (Etafilcon A With Print)|Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
67396|NCT01765972|O2|Outcome|Test 2 (Etafilcon A With Lacreon With Print)|Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
67397|NCT01765972|O1|Outcome|Test 1 (Etafilcon A With Lacreon)|Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
67398|NCT01765972|E4|Reported Event|Test 3 (Etafilcon A With Print)|Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study.
67399|NCT01765972|E3|Reported Event|Test 2 (Etafilcon A With Lacreon With Print)|Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study.
67400|NCT01765972|E2|Reported Event|Test 1 (Etafilcon A With Lacreon)|Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study.
67401|NCT01765972|E1|Reported Event|Spectacle|Subjects wore spectacles in any of the 4 periods of this study.
67402|NCT01765803|B1|Baseline|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
67403|NCT01765803|P1|Participant Flow|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
67404|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
67405|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
67406|NCT01765803|E1|Reported Event|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
67407|NCT01765764|B4|Baseline|Total|Total of all reporting groups
67408|NCT01765764|B3|Baseline|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67409|NCT01765764|B2|Baseline|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67410|NCT01765764|B1|Baseline|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67411|NCT01765764|P3|Participant Flow|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67412|NCT01765764|P2|Participant Flow|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67413|NCT01765764|P1|Participant Flow|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67414|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67415|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67416|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67417|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67418|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67419|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67420|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67421|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67422|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67423|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67424|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67425|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67426|NCT01765764|E3|Reported Event|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
67427|NCT01765764|E2|Reported Event|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
67428|NCT01765764|E1|Reported Event|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
67429|NCT01765569|B1|Baseline|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
67430|NCT01765569|P1|Participant Flow|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
67431|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67432|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67433|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67434|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67435|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67436|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67437|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67438|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67439|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67440|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67441|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67442|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67443|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67444|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67445|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
67446|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
67447|NCT01765569|E3|Reported Event|Period C|Single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35.
67448|NCT01765569|E2|Reported Event|Period B|Vemurafenib 960 mg orally BID from Day 8 to Day 28.
67449|NCT01765569|E1|Reported Event|Period A|Single oral dose of digoxin 0.25 mg tablet on Day 1.
67450|NCT01765543|B1|Baseline|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
67451|NCT01765543|P1|Participant Flow|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
67452|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67453|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67454|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67455|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67456|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67457|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67458|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67459|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67460|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67461|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67462|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67463|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67464|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67465|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67466|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67467|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67468|NCT01765543|E4|Reported Event|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
67469|NCT01765543|E3|Reported Event|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
67470|NCT01765543|E2|Reported Event|Rifampin (Intervention Period B)|Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
67471|NCT01765543|E1|Reported Event|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
67472|NCT01765465|B3|Baseline|Total|Total of all reporting groups
67473|NCT01765465|B2|Baseline|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
67474|NCT01765465|B1|Baseline|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
67475|NCT01765465|P2|Participant Flow|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
67476|NCT01765465|P1|Participant Flow|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
67477|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
67478|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
67479|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
67480|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
67481|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
67482|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
67483|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
67484|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
67485|NCT01765465|E2|Reported Event|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
67486|NCT01765465|E1|Reported Event|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
67487|NCT01765426|B5|Baseline|Total|Total of all reporting groups
67488|NCT01765426|B4|Baseline|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67489|NCT01765426|B3|Baseline|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67490|NCT01765426|B2|Baseline|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67491|NCT01765426|B1|Baseline|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67492|NCT01765426|P4|Participant Flow|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67493|NCT01765426|P3|Participant Flow|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67494|NCT01765426|P2|Participant Flow|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67495|NCT01765426|P1|Participant Flow|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67496|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67497|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
68954|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
67498|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67499|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67500|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67501|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67502|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67503|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67504|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67505|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67506|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67507|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67508|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67509|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67510|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67511|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67512|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67513|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67514|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67515|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67516|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67517|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67518|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67519|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67520|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67521|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
68955|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
67522|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67523|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67524|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67525|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67526|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67527|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67528|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67529|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67530|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67531|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67532|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67533|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67534|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67535|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67536|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67537|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67538|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67539|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67540|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67541|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
67542|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67543|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67544|NCT01765426|E4|Reported Event|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67545|NCT01765426|E3|Reported Event|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
68957|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
67546|NCT01765426|E2|Reported Event|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67547|NCT01765426|E1|Reported Event|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
67548|NCT01765270|B3|Baseline|Total|Total of all reporting groups
67549|NCT01765270|B2|Baseline|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67550|NCT01765270|B1|Baseline|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67551|NCT01765270|P2|Participant Flow|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67552|NCT01765270|P1|Participant Flow|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67553|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67554|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67555|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67556|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.daily
67557|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67558|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67559|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67560|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67561|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67562|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67563|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67564|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67565|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67566|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67567|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67568|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67569|NCT01765270|E2|Reported Event|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67570|NCT01765270|E1|Reported Event|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
67571|NCT01765192|B3|Baseline|Total|Total of all reporting groups
67628|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
67629|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
67572|NCT01765192|B2|Baseline|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67573|NCT01765192|B1|Baseline|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67574|NCT01765192|P2|Participant Flow|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67575|NCT01765192|P1|Participant Flow|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67576|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67577|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67578|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67579|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67580|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67581|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67582|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67583|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67584|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67585|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67586|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67587|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67588|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67589|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67590|NCT01765192|E2|Reported Event|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
67591|NCT01765192|E1|Reported Event|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
67592|NCT01764945|B9|Baseline|Total|Total of all reporting groups
67593|NCT01764945|B8|Baseline|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67594|NCT01764945|B7|Baseline|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67595|NCT01764945|B6|Baseline|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67596|NCT01764945|B5|Baseline|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67597|NCT01764945|B4|Baseline|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67598|NCT01764945|B3|Baseline|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67630|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
67631|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
67632|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
67599|NCT01764945|B2|Baseline|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67600|NCT01764945|B1|Baseline|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67601|NCT01764945|P8|Participant Flow|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67602|NCT01764945|P7|Participant Flow|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67603|NCT01764945|P6|Participant Flow|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67604|NCT01764945|P5|Participant Flow|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67605|NCT01764945|P4|Participant Flow|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67606|NCT01764945|P3|Participant Flow|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67607|NCT01764945|P2|Participant Flow|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67608|NCT01764945|P1|Participant Flow|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
67609|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
67610|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
67611|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
67612|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
67613|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
67614|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
67615|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
67616|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
67617|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
67618|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
67619|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
67620|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
67621|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
67622|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
67623|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
67624|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
67625|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
67626|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
67627|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
67636|NCT01764945|E5|Reported Event|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
67637|NCT01764945|E4|Reported Event|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3.
67638|NCT01764945|E3|Reported Event|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2.
67639|NCT01764945|E2|Reported Event|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1.
67640|NCT01764945|E1|Reported Event|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
67641|NCT01764919|B1|Baseline|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67642|NCT01764919|P1|Participant Flow|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67643|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67644|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67645|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67646|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67647|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67648|NCT01764919|E1|Reported Event|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
67649|NCT01764685|B3|Baseline|Total|Total of all reporting groups
67650|NCT01764685|B2|Baseline|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67651|NCT01764685|B1|Baseline|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67652|NCT01764685|P2|Participant Flow|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67653|NCT01764685|P1|Participant Flow|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150 mg/day~Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67666|NCT01764386|P2|Participant Flow|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."
67754|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67654|NCT01764685|O2|Outcome|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67655|NCT01764685|O1|Outcome|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/wk."
67656|NCT01764685|E2|Reported Event|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
67657|NCT01764685|E1|Reported Event|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drink"
67658|NCT01764607|B1|Baseline|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
67659|NCT01764607|P1|Participant Flow|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
67660|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
67661|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
67662|NCT01764607|E1|Reported Event|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
67663|NCT01764386|B3|Baseline|Total|Total of all reporting groups
67664|NCT01764386|B2|Baseline|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67665|NCT01764386|B1|Baseline|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67688|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67755|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67667|NCT01764386|P1|Participant Flow|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."
67668|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67669|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67670|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67671|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67672|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67673|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67674|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67675|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67676|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67677|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67678|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67679|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67680|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67681|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67682|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67683|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67684|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67685|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67686|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67687|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67748|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67689|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67690|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67691|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67692|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67693|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67694|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67695|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67696|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67697|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67698|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67699|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67700|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67701|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67702|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
67703|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
67704|NCT01764386|E3|Reported Event|All Subjects (Entire Study)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study."
67705|NCT01764386|E2|Reported Event|Usual Care (Controlled Treatment Period)|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26."
67706|NCT01764386|E1|Reported Event|NB + CLI (Controlled Treatment Period)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26."
67707|NCT01764022|B3|Baseline|Total|Total of all reporting groups
67708|NCT01764022|B2|Baseline|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67749|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67750|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
109244|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
67709|NCT01764022|B1|Baseline|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67710|NCT01764022|P2|Participant Flow|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67711|NCT01764022|P1|Participant Flow|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67712|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67713|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67714|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67715|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67716|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67717|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67718|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67719|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67720|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67721|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67722|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67723|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67724|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67751|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67752|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67753|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67725|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67726|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67727|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67728|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67729|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67730|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67731|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67732|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67733|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67734|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67735|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67736|NCT01764022|E2|Reported Event|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67737|NCT01764022|E1|Reported Event|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
67738|NCT01763996|B1|Baseline|All Participants|All participants who were randomized and received study drug (febuxostat 80 mg and placebo) during the study.
67739|NCT01763996|P2|Participant Flow|Sequence 2: Placebo + Febuxostat 80 mg|Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
67740|NCT01763996|P1|Participant Flow|Sequence 1: Febuxostat 80 mg + Placebo|Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2.
67741|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67742|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67743|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67744|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67745|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67746|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67747|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67756|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67757|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67758|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67759|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67760|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67761|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67762|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67763|NCT01763996|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67764|NCT01763996|E1|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
67765|NCT01763918|B5|Baseline|Total|Total of all reporting groups
67766|NCT01763918|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67767|NCT01763918|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67768|NCT01763918|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67769|NCT01763918|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67770|NCT01763918|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67771|NCT01763918|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67772|NCT01763918|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67773|NCT01763918|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67774|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67775|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67776|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67777|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67778|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67779|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67780|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67781|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67782|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67783|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67784|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67785|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67786|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67787|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67788|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67789|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67790|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67791|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67792|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67793|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67794|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67795|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67796|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67797|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67798|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67799|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67800|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67801|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67802|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67803|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67804|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67805|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67806|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67807|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67808|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67809|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67810|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67811|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67812|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67813|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67814|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67815|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67816|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67817|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67818|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67819|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67820|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67821|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67822|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67823|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67824|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67825|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67826|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67827|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67828|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67829|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67830|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67831|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67832|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67833|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67834|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67835|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67836|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67837|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67838|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67839|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67840|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67841|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67842|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67843|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67844|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67845|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67846|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67847|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67848|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67849|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67850|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67851|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67852|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67853|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67854|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67855|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67856|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67857|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67858|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67859|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67860|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67861|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67862|NCT01763918|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67863|NCT01763918|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67864|NCT01763918|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
67865|NCT01763918|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
67866|NCT01763905|B5|Baseline|Total|Total of all reporting groups
67867|NCT01763905|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67868|NCT01763905|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67869|NCT01763905|B2|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67870|NCT01763905|B1|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67871|NCT01763905|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67872|NCT01763905|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67873|NCT01763905|P2|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67874|NCT01763905|P1|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67875|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67876|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67877|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67878|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67879|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67880|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67881|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67882|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67883|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67884|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67885|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67886|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67887|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67888|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67889|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67890|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67891|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67892|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67893|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67894|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67895|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67896|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67897|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67898|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67899|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67900|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67901|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67902|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67903|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67904|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67905|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67906|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67907|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67908|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67909|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67910|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67911|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67912|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67913|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67914|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67915|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67916|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67917|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67918|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67919|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67920|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67921|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67922|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67923|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67924|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67925|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67926|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67927|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67928|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67929|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67930|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67931|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67932|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67933|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67934|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67935|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67936|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67937|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67938|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67939|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67940|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67941|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67942|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67943|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67944|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67945|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67946|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67947|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67948|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67949|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67950|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67951|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67952|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67953|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67954|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67955|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67956|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67957|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67958|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67959|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67960|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67961|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67962|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67963|NCT01763905|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
67964|NCT01763905|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
67965|NCT01763905|E2|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
67966|NCT01763905|E1|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
67967|NCT01763866|B25|Baseline|Total|Total of all reporting groups
67968|NCT01763866|B24|Baseline|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67969|NCT01763866|B23|Baseline|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68591|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
67970|NCT01763866|B22|Baseline|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
67971|NCT01763866|B21|Baseline|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
67972|NCT01763866|B20|Baseline|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67973|NCT01763866|B19|Baseline|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67974|NCT01763866|B18|Baseline|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
67975|NCT01763866|B17|Baseline|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
67976|NCT01763866|B16|Baseline|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67977|NCT01763866|B15|Baseline|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67978|NCT01763866|B14|Baseline|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
67979|NCT01763866|B13|Baseline|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
67980|NCT01763866|B12|Baseline|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
67981|NCT01763866|B11|Baseline|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
67982|NCT01763866|B10|Baseline|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
67983|NCT01763866|B9|Baseline|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
67984|NCT01763866|B8|Baseline|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
67985|NCT01763866|B7|Baseline|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
67986|NCT01763866|B6|Baseline|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
67987|NCT01763866|B5|Baseline|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
67988|NCT01763866|B4|Baseline|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
67989|NCT01763866|B3|Baseline|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
67990|NCT01763866|B2|Baseline|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
67991|NCT01763866|B1|Baseline|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
67992|NCT01763866|P24|Participant Flow|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67993|NCT01763866|P23|Participant Flow|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67994|NCT01763866|P22|Participant Flow|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
67995|NCT01763866|P21|Participant Flow|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
67996|NCT01763866|P20|Participant Flow|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
67997|NCT01763866|P19|Participant Flow|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
67998|NCT01763866|P18|Participant Flow|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
67999|NCT01763866|P17|Participant Flow|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68000|NCT01763866|P16|Participant Flow|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68001|NCT01763866|P15|Participant Flow|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68002|NCT01763866|P14|Participant Flow|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68003|NCT01763866|P13|Participant Flow|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68004|NCT01763866|P12|Participant Flow|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68005|NCT01763866|P11|Participant Flow|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68006|NCT01763866|P10|Participant Flow|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68007|NCT01763866|P9|Participant Flow|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68008|NCT01763866|P8|Participant Flow|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68009|NCT01763866|P7|Participant Flow|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68010|NCT01763866|P6|Participant Flow|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68011|NCT01763866|P5|Participant Flow|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68012|NCT01763866|P4|Participant Flow|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68013|NCT01763866|P3|Participant Flow|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68014|NCT01763866|P2|Participant Flow|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68015|NCT01763866|P1|Participant Flow|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68016|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68017|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68018|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68019|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68020|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68021|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68022|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68023|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68024|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68592|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68025|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68026|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68027|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68028|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68029|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68030|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68031|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68032|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68033|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68034|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68035|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68036|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68037|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68038|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68039|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68040|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68041|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68042|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68043|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68044|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68045|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68046|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68047|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68048|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68049|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68050|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68051|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68052|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
109245|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
68053|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68054|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68055|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68056|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68057|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68058|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68059|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68060|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68061|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68062|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68063|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68064|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68065|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68066|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68067|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68068|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68069|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68070|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68071|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68072|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68073|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68074|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68075|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68076|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68077|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68078|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68079|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68080|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68081|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68082|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68083|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68084|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68085|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68086|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68087|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68088|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68089|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68090|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68091|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68092|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68093|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68094|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68095|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68096|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68097|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68098|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68099|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68100|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68101|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68102|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68103|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68104|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68105|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68106|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68107|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68136|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68108|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68109|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68110|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68111|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68112|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68113|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68114|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68115|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68116|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68117|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68118|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68119|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68120|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68121|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68122|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68123|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68124|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68125|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68126|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68127|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68128|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68129|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68130|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68131|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68132|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68133|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68134|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68135|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68137|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68138|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68139|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68140|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68141|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68142|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68143|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68144|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68145|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68146|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68147|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68148|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68149|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68150|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68151|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68152|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68153|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68154|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68155|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68156|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68157|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68158|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68159|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68160|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68161|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68162|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68163|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68164|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68958|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
68165|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68166|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68167|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68168|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68169|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68170|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68171|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68172|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68173|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68174|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68175|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68176|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68177|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68178|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68179|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68180|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68181|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68182|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68183|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68184|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68185|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68186|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68187|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68188|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68189|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68190|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68191|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68192|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68959|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
68193|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68194|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68195|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68196|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68197|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68198|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68199|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68200|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68201|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68202|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68203|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68204|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68205|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68206|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68207|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68208|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68209|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68210|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68211|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68212|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68213|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68214|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68215|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68216|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68217|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68218|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68219|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68220|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
109246|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
68221|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68222|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68223|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68224|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68225|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68226|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68227|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68228|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68229|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68230|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68231|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68232|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68233|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68234|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68235|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68236|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68237|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68238|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68239|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68240|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68241|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68242|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68243|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68244|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68245|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68246|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68247|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68248|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68249|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68250|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68251|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68252|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68253|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68254|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68255|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68256|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68257|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68258|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68259|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68260|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68261|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68262|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68263|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68264|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68265|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68266|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68267|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68268|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68269|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68270|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68271|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68272|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68273|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68274|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68275|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68304|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68276|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68277|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68278|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68279|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68280|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68281|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68282|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68283|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68284|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68285|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68286|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68287|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68288|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68289|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68290|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68291|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68292|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68293|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68294|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68295|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68296|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68297|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68298|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68299|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68300|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68301|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68302|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68303|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68305|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68306|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68307|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68308|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68309|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68310|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68311|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68312|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68313|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68314|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68315|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68316|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68317|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68318|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68319|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68320|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68321|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68322|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68323|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68324|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68325|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68326|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68327|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68328|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68329|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68330|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68331|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68332|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68960|NCT01762345|E1|Reported Event|Pessary Device|pessary (disposable intra-vaginal device)
68333|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68334|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68335|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68336|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68337|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68338|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68339|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68340|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68341|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68342|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68343|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68344|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68345|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68346|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68347|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68348|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68349|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68350|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68351|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68352|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68353|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68354|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68355|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68356|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68357|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68358|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68359|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68360|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68961|NCT01761747|B1|Baseline|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68361|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68362|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68363|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68364|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68365|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68366|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68367|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68368|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68369|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68370|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68371|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68372|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68373|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68374|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68375|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68376|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68377|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68378|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68379|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68380|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68381|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68382|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68383|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68384|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68385|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68386|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68387|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68388|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
109247|NCT01548287|O4|Outcome|Placebo|Placebo daily
68389|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68390|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68391|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68392|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68393|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68394|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68395|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68396|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68397|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68398|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68399|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68400|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68401|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68402|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68403|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68404|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68405|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68406|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68407|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68408|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68409|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68410|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68411|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68412|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68413|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68414|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68415|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68416|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68417|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68418|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68419|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68420|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68421|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68422|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68423|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68424|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68425|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68426|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68427|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68428|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68429|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68430|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68431|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68432|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68433|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68434|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68435|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68436|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68437|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68438|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68439|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68440|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68441|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68442|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68443|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68472|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68444|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68445|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68446|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68447|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68448|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68449|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68450|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68451|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68452|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68453|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68454|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68455|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68456|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68457|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68458|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68459|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68460|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68461|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68462|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68463|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68464|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68465|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68466|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68467|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68468|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68469|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68470|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68471|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68473|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68474|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68475|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68476|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68477|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68478|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68479|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68480|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68481|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68482|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68483|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68484|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68485|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68486|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68487|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68488|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68489|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68490|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68491|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68492|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68493|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68494|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68495|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68496|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68497|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68498|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68499|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68500|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68962|NCT01761747|P1|Participant Flow|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68501|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68502|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68503|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68504|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68505|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68506|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68507|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68508|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68509|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68510|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68511|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68512|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68513|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68514|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68515|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68516|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68517|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68518|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68519|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68520|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68521|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68522|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68523|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68524|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68525|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68526|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68527|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68528|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68963|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68529|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68530|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68531|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68532|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68533|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68534|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68535|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68536|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68537|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68538|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68539|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68540|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68541|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68542|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68543|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68544|NCT01763866|E24|Reported Event|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68545|NCT01763866|E23|Reported Event|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68546|NCT01763866|E22|Reported Event|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68547|NCT01763866|E21|Reported Event|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68548|NCT01763866|E20|Reported Event|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68549|NCT01763866|E19|Reported Event|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68550|NCT01763866|E18|Reported Event|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68551|NCT01763866|E17|Reported Event|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68552|NCT01763866|E16|Reported Event|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
68553|NCT01763866|E15|Reported Event|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
68554|NCT01763866|E14|Reported Event|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
68555|NCT01763866|E13|Reported Event|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
68556|NCT01763866|E12|Reported Event|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68557|NCT01763866|E11|Reported Event|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68558|NCT01763866|E10|Reported Event|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68559|NCT01763866|E9|Reported Event|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
68560|NCT01763866|E8|Reported Event|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68561|NCT01763866|E7|Reported Event|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68562|NCT01763866|E6|Reported Event|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
68563|NCT01763866|E5|Reported Event|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
68564|NCT01763866|E4|Reported Event|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
68565|NCT01763866|E3|Reported Event|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
68566|NCT01763866|E2|Reported Event|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
68567|NCT01763866|E1|Reported Event|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
68568|NCT01763827|B7|Baseline|Total|Total of all reporting groups
68569|NCT01763827|B6|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68570|NCT01763827|B5|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68571|NCT01763827|B4|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68572|NCT01763827|B3|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68573|NCT01763827|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68574|NCT01763827|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68575|NCT01763827|P6|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68576|NCT01763827|P5|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68577|NCT01763827|P4|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68578|NCT01763827|P3|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68579|NCT01763827|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68580|NCT01763827|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68581|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68582|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68583|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68584|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68585|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68586|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68587|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68588|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68589|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68590|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68593|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68594|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68595|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68596|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68597|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68598|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68599|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68600|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68601|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68602|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68603|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68604|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68605|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68606|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68607|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68608|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68609|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68610|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68611|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68612|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68613|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68614|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68615|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68616|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68617|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68618|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68619|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68620|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68621|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68622|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68623|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68624|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68625|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68626|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68627|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68628|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68629|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68630|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68631|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68964|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68632|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68633|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68634|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68635|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68636|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68637|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68638|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68639|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68640|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68641|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68642|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68643|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68644|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68645|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68646|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68647|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68648|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68649|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68650|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68651|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68652|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68653|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68654|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68655|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68656|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68657|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68658|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68659|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68660|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68661|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68662|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68663|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68664|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68665|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68666|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68667|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68668|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68669|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68670|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68965|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68671|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68672|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68673|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68674|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68675|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68676|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68677|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68678|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68679|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68680|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68681|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68682|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68683|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68684|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68685|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68686|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68687|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68688|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68689|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68690|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68691|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68692|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68693|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68694|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68695|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68696|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68697|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68698|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68699|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68700|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68701|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68702|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68703|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68704|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68705|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68706|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68707|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68708|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68709|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68966|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68710|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68711|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68712|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68713|NCT01763827|E6|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
68714|NCT01763827|E5|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
68715|NCT01763827|E4|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
68716|NCT01763827|E3|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
68717|NCT01763827|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
68718|NCT01763827|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
68719|NCT01763645|B3|Baseline|Total|Total of all reporting groups
68720|NCT01763645|B2|Baseline|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
68721|NCT01763645|B1|Baseline|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68722|NCT01763645|P2|Participant Flow|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68723|NCT01763645|P1|Participant Flow|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68724|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68725|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68726|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68727|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68728|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68729|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68730|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68756|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
68731|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68732|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68733|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68734|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68735|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68736|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
68737|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
68738|NCT01763645|E2|Reported Event|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
68739|NCT01763645|E1|Reported Event|BCD-021 (CISC BIOCAD)|"In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
68740|NCT01763567|B1|Baseline|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68741|NCT01763567|P1|Participant Flow|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68742|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68743|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68744|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68745|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68746|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68747|NCT01763567|E1|Reported Event|Observation Arm|To assess safety and device performance for the Hospital Glucose Managment system
68748|NCT01763047|B3|Baseline|Total|Total of all reporting groups
68749|NCT01763047|B2|Baseline|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
68750|NCT01763047|B1|Baseline|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
68751|NCT01763047|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
68752|NCT01763047|P1|Participant Flow|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
68753|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
68754|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
68755|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
68967|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68757|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
68758|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
68759|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
68760|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
68761|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
68762|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
68763|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
68764|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
68765|NCT01763047|E2|Reported Event|Control (Lotrafilcon B)|Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
68766|NCT01763047|E1|Reported Event|Test (Etafilcon A)|Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.
68767|NCT01762982|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
68768|NCT01762982|P1|Participant Flow|Overall|This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
68769|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68770|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68771|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68772|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68773|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
68774|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68775|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68776|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68777|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
68778|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68779|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68780|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68781|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68782|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68783|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
68784|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68785|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68786|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
68787|NCT01762982|E1|Reported Event|Overall Study|"This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.~All randomized participants exposed to at least one of the study treatments were evaluated for safety."
68799|NCT01762800|P1|Participant Flow|TIO 18 µg QD|Participants received 18 micrograms (µg) tiotropium bromide (TIO) once daily (QD) via HandiHaler inhaler and placebo twice daily (BID) via dry powder inhaler (DPI), during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68956|NCT01762345|O1|Outcome|Pessary Device|"pessary (disposable intra-vaginal device)~pessary (disposable intra-vaginal device): pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble"
68788|NCT01762904|B1|Baseline|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
68789|NCT01762904|P1|Participant Flow|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
68790|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
68791|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test two controls: Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
68792|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
68793|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
68794|NCT01762904|E1|Reported Event|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
68795|NCT01762800|B3|Baseline|Total|Total of all reporting groups
68796|NCT01762800|B2|Baseline|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68797|NCT01762800|B1|Baseline|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68798|NCT01762800|P2|Participant Flow|SAL/FLU 50/250 µg BID|Participants received 50/250 µg salmeterol xinafoate (SAL)/fluticasone propionate (FLU) BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68906|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68800|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68801|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68802|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68803|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68804|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68805|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68806|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68807|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68808|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68809|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68810|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68811|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68812|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68813|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68814|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68815|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68816|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68907|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68817|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68818|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68819|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68820|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68821|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68822|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68823|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68824|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68825|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68826|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68827|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68828|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68829|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68830|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68831|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68832|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
109248|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
68833|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68834|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68835|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68836|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68837|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68838|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68839|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68840|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68841|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68842|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68843|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68844|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68845|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68846|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68847|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68848|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68908|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
109249|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
68849|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68850|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68851|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68852|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68853|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68854|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68855|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68856|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68857|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68858|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68859|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68860|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68861|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68862|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68863|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68864|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68865|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
68866|NCT01762800|E4|Reported Event|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68909|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
109250|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
68867|NCT01762800|E3|Reported Event|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
68868|NCT01762800|E2|Reported Event|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
68869|NCT01762800|E1|Reported Event|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
68870|NCT01762761|B3|Baseline|Total|Total of all reporting groups
68871|NCT01762761|B2|Baseline|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68872|NCT01762761|B1|Baseline|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68873|NCT01762761|P2|Participant Flow|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68874|NCT01762761|P1|Participant Flow|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68875|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68876|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68877|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68878|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68879|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68880|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68881|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68910|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68882|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68883|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68884|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
68885|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68886|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68887|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68888|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68889|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68890|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68891|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68892|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68893|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68894|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68895|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68896|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68897|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68898|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68899|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68900|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68901|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68902|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68903|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68904|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68905|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68951|NCT01762345|B1|Baseline|Pessary Device|pessary (disposable intra-vaginal device)
68911|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68912|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68913|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68914|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68915|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68916|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68917|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68918|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68919|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68920|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68921|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68922|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68923|NCT01762761|E2|Reported Event|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68924|NCT01762761|E1|Reported Event|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
68925|NCT01762722|B3|Baseline|Total|Total of all reporting groups
68926|NCT01762722|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
68927|NCT01762722|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
68928|NCT01762722|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
68929|NCT01762722|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
68930|NCT01762722|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
68931|NCT01762722|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
68932|NCT01762722|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
68933|NCT01762722|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
68934|NCT01762501|B3|Baseline|Total|Total of all reporting groups
68935|NCT01762501|B2|Baseline|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68936|NCT01762501|B1|Baseline|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68937|NCT01762501|P2|Participant Flow|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68938|NCT01762501|P1|Participant Flow|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68939|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68940|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68941|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68942|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68943|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68944|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68945|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68946|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68947|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68948|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68949|NCT01762501|E2|Reported Event|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
68950|NCT01762501|E1|Reported Event|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
68968|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68969|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68970|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68971|NCT01761747|E1|Reported Event|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
68972|NCT01761565|B1|Baseline|One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Single dose of SUF NT 15 mcg~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~40 consecutive doses of SUF NT 15 mcg"
68973|NCT01761565|P1|Participant Flow|Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2."
68974|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
68975|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|Arm 1/Period 1: Single dose of SUF NT 15 mcg
68976|NCT01761565|O1|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
68977|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
68978|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|
68979|NCT01761565|E2|Reported Event|40 Consecutive Doses of SUF NT 15 mcg|
68980|NCT01761565|E1|Reported Event|Single Dose of SUF NT 15 mcg|
68981|NCT01761279|B1|Baseline|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
68982|NCT01761279|P1|Participant Flow|HDWL and i-Scan Assessment|High Definition White Light Endoscopy.
68983|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
68984|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
68985|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
68986|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
68987|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
68988|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
68989|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
68990|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
68991|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
68992|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
68993|NCT01761279|E1|Reported Event|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
68994|NCT01761162|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
68995|NCT01761162|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
68996|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
68997|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
68998|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
68999|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
69000|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
69001|NCT01761162|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
69002|NCT01761019|B1|Baseline|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69003|NCT01761019|P1|Participant Flow|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69004|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69005|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69006|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69007|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69008|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69009|NCT01761019|E1|Reported Event|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
69010|NCT01760993|B1|Baseline|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69011|NCT01760993|P1|Participant Flow|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69012|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69013|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69014|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69015|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69016|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69017|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69018|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69019|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69020|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69021|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69022|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69023|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69024|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69025|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69026|NCT01760993|E1|Reported Event|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
69027|NCT01760941|B1|Baseline|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69028|NCT01760941|P1|Participant Flow|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69029|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69030|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69031|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69032|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69033|NCT01760941|E1|Reported Event|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
69034|NCT01760889|B4|Baseline|Total|Total of all reporting groups
69035|NCT01760889|B3|Baseline|Placebo|Placebo: One capsule a day for 26 weeks
69036|NCT01760889|B2|Baseline|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69037|NCT01760889|B1|Baseline|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69038|NCT01760889|P3|Participant Flow|Placebo|Placebo: One capsule a day for 26 weeks
69039|NCT01760889|P2|Participant Flow|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69040|NCT01760889|P1|Participant Flow|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69041|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69111|NCT01759420|E1|Reported Event|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
69112|NCT01759381|B3|Baseline|Total|Total of all reporting groups
69042|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69043|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69044|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69045|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69046|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69047|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69048|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69049|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69050|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69051|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69052|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69053|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69054|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69055|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69056|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69057|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69058|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69059|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69060|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69113|NCT01759381|B2|Baseline|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
69159|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69061|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69062|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69063|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69064|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69065|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69066|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69067|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69068|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69069|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69070|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69071|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69072|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69073|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69074|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69075|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69076|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69077|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69078|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69079|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69080|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
69114|NCT01759381|B1|Baseline|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
69160|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69081|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69082|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69083|NCT01760889|E3|Reported Event|Placebo|Placebo: One capsule a day for 26 weeks
69084|NCT01760889|E2|Reported Event|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
69085|NCT01760889|E1|Reported Event|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
69086|NCT01760876|B1|Baseline|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
69087|NCT01760876|P1|Participant Flow|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
69088|NCT01760876|O1|Outcome|Biofreedom Stent|The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
69089|NCT01760876|E1|Reported Event|Biofreedom Stent|The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
69090|NCT01760785|B3|Baseline|Total|Total of all reporting groups
69091|NCT01760785|B2|Baseline|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
69092|NCT01760785|B1|Baseline|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
69093|NCT01760785|P2|Participant Flow|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
69094|NCT01760785|P1|Participant Flow|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
69095|NCT01760785|O2|Outcome|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
69115|NCT01759381|P2|Participant Flow|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
70322|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
69096|NCT01760785|O1|Outcome|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
69097|NCT01760785|E2|Reported Event|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
69098|NCT01760785|E1|Reported Event|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
69099|NCT01759602|B1|Baseline|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69100|NCT01759602|P1|Participant Flow|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69101|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69102|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69103|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69104|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69105|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69106|NCT01759602|E1|Reported Event|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
69107|NCT01759420|B1|Baseline|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
69108|NCT01759420|P1|Participant Flow|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
69109|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
69110|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
69156|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69116|NCT01759381|P1|Participant Flow|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
69117|NCT01759381|O2|Outcome|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
69118|NCT01759381|O1|Outcome|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
69119|NCT01759381|E2|Reported Event|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
69120|NCT01759381|E1|Reported Event|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
69121|NCT01759368|B3|Baseline|Total|Total of all reporting groups
69122|NCT01759368|B2|Baseline|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity.
69123|NCT01759368|B1|Baseline|Telemonitoring-assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak
69124|NCT01759368|P2|Participant Flow|Control Group|Control group received multidisciplinary care that was standard.
69125|NCT01759368|P1|Participant Flow|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
69126|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69127|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69128|NCT01759368|O2|Outcome|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients’ visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient’s own activity
69129|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
69130|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69157|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69158|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
71969|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
69131|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69132|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69133|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69134|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69135|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69136|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69137|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69138|NCT01759368|O2|Outcome|Control Group|Control group received usual care
69139|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69140|NCT01759368|E2|Reported Event|Control Group|Control group received usual care
69141|NCT01759368|E1|Reported Event|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
69142|NCT01759290|B1|Baseline|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69143|NCT01759290|P1|Participant Flow|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69144|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69145|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69146|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69147|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69148|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69149|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69150|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69151|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69152|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69153|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69154|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69155|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
72029|NCT01738698|E4|Reported Event|Placebo|Placebo: Oral administration once-daily for 12 weeks
69161|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69162|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69163|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69164|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69165|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69166|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69167|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69168|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69169|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69170|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69171|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69172|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69173|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69174|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69175|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69176|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69177|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69178|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69179|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69180|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69181|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69182|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69183|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69184|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69185|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69186|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69187|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69188|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69189|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69190|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69191|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69192|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69193|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69194|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69195|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69196|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69197|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69198|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69199|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69200|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69201|NCT01759290|E1|Reported Event|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
69202|NCT01759264|B1|Baseline|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69203|NCT01759264|P1|Participant Flow|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69204|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69205|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69206|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69207|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69208|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69209|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69210|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69211|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69212|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69213|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69214|NCT01759264|E1|Reported Event|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
69215|NCT01759251|B1|Baseline|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
69216|NCT01759251|P1|Participant Flow|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
69217|NCT01759251|O1|Outcome|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
69218|NCT01759251|E1|Reported Event|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
69219|NCT01759160|B3|Baseline|Total|Total of all reporting groups
69220|NCT01759160|B2|Baseline|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69221|NCT01759160|B1|Baseline|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69222|NCT01759160|P2|Participant Flow|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69223|NCT01759160|P1|Participant Flow|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69224|NCT01759160|O2|Outcome|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69225|NCT01759160|O1|Outcome|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69226|NCT01759160|E2|Reported Event|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69227|NCT01759160|E1|Reported Event|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
69228|NCT01758900|B3|Baseline|Total|Total of all reporting groups
69229|NCT01758900|B2|Baseline|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69230|NCT01758900|B1|Baseline|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69231|NCT01758900|P2|Participant Flow|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69232|NCT01758900|P1|Participant Flow|CO2(Carbon Dioxide) Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy)."
69233|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69234|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69235|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69236|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69237|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69238|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69239|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69240|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
109251|NCT01548287|O4|Outcome|Placebo|Placebo daily
69241|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69242|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69243|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69244|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69245|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69246|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69247|NCT01758900|E2|Reported Event|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69248|NCT01758900|E1|Reported Event|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
69249|NCT01758289|B1|Baseline|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69250|NCT01758289|P1|Participant Flow|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69251|NCT01758289|O2|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69252|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69253|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69254|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69255|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69256|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69257|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69258|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69259|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69260|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69261|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69262|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69263|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
72802|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion SF-36 Scores
69264|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69265|NCT01758289|E1|Reported Event|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
69266|NCT01757964|B3|Baseline|Total|Total of all reporting groups
69267|NCT01757964|B2|Baseline|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
69268|NCT01757964|B1|Baseline|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
69269|NCT01757964|P2|Participant Flow|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
69270|NCT01757964|P1|Participant Flow|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
69271|NCT01757964|O1|Outcome|Bacteriotherapy|"Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.~Bacteriotherapy"
69272|NCT01757964|E1|Reported Event|Bacteriotherapy|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
69273|NCT01757847|B3|Baseline|Total|Total of all reporting groups
69274|NCT01757847|B2|Baseline|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
69275|NCT01757847|B1|Baseline|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
69276|NCT01757847|P2|Participant Flow|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
69328|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69329|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69626|NCT01754922|B2|Baseline|Control|Veterans deployed to regions other than Iraq or Afghanistan or non-deployed
69277|NCT01757847|P1|Participant Flow|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
69278|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
69279|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
69280|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
69281|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
69282|NCT01757847|E2|Reported Event|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
69283|NCT01757847|E1|Reported Event|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
69284|NCT01757704|B3|Baseline|Total|Total of all reporting groups
69285|NCT01757704|B2|Baseline|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69286|NCT01757704|B1|Baseline|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69330|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
69331|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
109252|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
69287|NCT01757704|P2|Participant Flow|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69288|NCT01757704|P1|Participant Flow|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69289|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69290|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69291|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69292|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69293|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69332|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69333|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
109253|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
69294|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69295|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69296|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69297|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69298|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69299|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69300|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69334|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
69335|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
109254|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
69301|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69302|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69303|NCT01757704|E2|Reported Event|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
69304|NCT01757704|E1|Reported Event|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
69305|NCT01757691|B1|Baseline|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69306|NCT01757691|P2|Participant Flow|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69307|NCT01757691|P1|Participant Flow|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69308|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69309|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69310|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69311|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69312|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69313|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69314|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69315|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69316|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69317|NCT01757691|E2|Reported Event|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
69318|NCT01757691|E1|Reported Event|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
69319|NCT01757561|B5|Baseline|Total|Total of all reporting groups
69320|NCT01757561|B4|Baseline|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69321|NCT01757561|B3|Baseline|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69322|NCT01757561|B2|Baseline|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
69323|NCT01757561|B1|Baseline|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
69324|NCT01757561|P4|Participant Flow|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69325|NCT01757561|P3|Participant Flow|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69326|NCT01757561|P2|Participant Flow|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
69327|NCT01757561|P1|Participant Flow|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
69336|NCT01757561|E4|Reported Event|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69337|NCT01757561|E3|Reported Event|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
69338|NCT01757561|E2|Reported Event|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
69339|NCT01757561|E1|Reported Event|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
69340|NCT01757405|B3|Baseline|Total|Total of all reporting groups
69341|NCT01757405|B2|Baseline|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69342|NCT01757405|B1|Baseline|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69343|NCT01757405|P2|Participant Flow|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69344|NCT01757405|P1|Participant Flow|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69345|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69346|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69347|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69348|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69349|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69350|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69351|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69352|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69353|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69354|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69355|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69356|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
69357|NCT01757405|E2|Reported Event|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
69358|NCT01757405|E1|Reported Event|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
69359|NCT01757275|B3|Baseline|Total|Total of all reporting groups
69360|NCT01757275|B2|Baseline|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69361|NCT01757275|B1|Baseline|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69362|NCT01757275|P2|Participant Flow|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69363|NCT01757275|P1|Participant Flow|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69364|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69365|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69366|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69367|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69368|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69369|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69627|NCT01754922|B1|Baseline|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69370|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69371|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69372|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69373|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69374|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69375|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69376|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69377|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69378|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69379|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69380|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69381|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69382|NCT01757275|E2|Reported Event|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69383|NCT01757275|E1|Reported Event|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
69384|NCT01757184|B3|Baseline|Total|Total of all reporting groups
69385|NCT01757184|B2|Baseline|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69386|NCT01757184|B1|Baseline|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69387|NCT01757184|P2|Participant Flow|Double-Blind Placebo Followed by Open-Label SA|Double-blind Period: IV infusions of placebo administered once every other week (qow); Open-Label Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
69388|NCT01757184|P1|Participant Flow|Double-blind SA, Followed by Open-Label SA|Double-blind Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow); Open-Label Period: IV infusions of SA at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
69389|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69390|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69391|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69392|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69393|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69394|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69395|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69396|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69397|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69398|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69399|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69400|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69401|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69402|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69403|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69404|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69405|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69406|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69407|NCT01757184|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
69408|NCT01757184|E1|Reported Event|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
69409|NCT01756976|B3|Baseline|Total|Total of all reporting groups
109255|NCT01548287|E4|Reported Event|Placebo|Placebo daily
69410|NCT01756976|B2|Baseline|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
69411|NCT01756976|B1|Baseline|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
69412|NCT01756976|P2|Participant Flow|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
69413|NCT01756976|P1|Participant Flow|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
69414|NCT01756976|O2|Outcome|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
69415|NCT01756976|O1|Outcome|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
69416|NCT01756976|E2|Reported Event|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
69417|NCT01756976|E1|Reported Event|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
69418|NCT01756391|B1|Baseline|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
69419|NCT01756391|P1|Participant Flow|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
69420|NCT01756391|O1|Outcome|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
69421|NCT01756391|E1|Reported Event|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
69422|NCT01756300|B1|Baseline|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
69423|NCT01756300|P1|Participant Flow|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
69424|NCT01756300|O4|Outcome|AT Twelve Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at Twelve month post-procedure
69425|NCT01756300|O3|Outcome|At Six Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at six month post-procedure
69426|NCT01756300|O2|Outcome|At Three Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at three month post-procedure
69427|NCT01756300|O1|Outcome|At One Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at one month post-procedure
69428|NCT01756300|O4|Outcome|At Twelve Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at twelve month post-procedure
69429|NCT01756300|O3|Outcome|At Six Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at six month post-procedure
69430|NCT01756300|O2|Outcome|At Three Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at three month post-procedure
69431|NCT01756300|O1|Outcome|At One Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at one month post-procedure
69432|NCT01756300|O4|Outcome|Blood Pressures at 12-Month Follow Up|ABPM blood pressures measured at 12-month post procedure
69433|NCT01756300|O3|Outcome|Blood Pressures at 6-Month Follow Up|ABPM blood pressures measured at 6-month post procedure
69434|NCT01756300|O2|Outcome|Blood Pressures at 3-Month Follow Up|ABPM blood pressures measured at 3-month post procedure
69435|NCT01756300|O1|Outcome|Blood Pressures at Baseline|ABPM blood pressures measured at Baseline
69436|NCT01756300|O5|Outcome|Blood Pressures at 12-Month Follow Up|Office blood pressures measured at 12-month post procedure
69437|NCT01756300|O4|Outcome|Blood Pressures at 6-Month Follow Up|Office blood pressures measured at 6-month post procedure
69438|NCT01756300|O3|Outcome|Blood Pressures at 3-Month Follow Up|Office blood pressures measured at 3-month post procedure
69439|NCT01756300|O2|Outcome|Blood Pressures at 1-Month Follow Up|Office blood pressures measured at one month post-procedure
69440|NCT01756300|O1|Outcome|Blood Pressures at Baseline|Office blood pressures measured at Baseline
69441|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
69442|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
69443|NCT01756300|E1|Reported Event|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
69444|NCT01756274|B1|Baseline|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects.
69445|NCT01756274|P1|Participant Flow|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS.
69492|NCT01756053|E1|Reported Event|ABT-089|"Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
69446|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
69447|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
69448|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
69449|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
69450|NCT01756274|E1|Reported Event|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory.
69451|NCT01756157|B1|Baseline|Entire Study Population|Included participants who received 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment A) first and 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment B) first.
69452|NCT01756157|P2|Participant Flow|Treatment Sequence B/A|"Participants received Treatment B in Period 1 and Treatment A in Period 2; for 8 weeks each as a single 20 mL SC injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
69453|NCT01756157|P1|Participant Flow|Treatment Sequence A/B|"Participants received Treatment A in Period 1 and Treatment B in Period 2; for 8 weeks each as a single 20 milliliter (mL) subcutaneous (SC) injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
69454|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69455|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69456|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69457|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69458|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69459|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69460|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69461|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69462|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69463|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69464|NCT01756157|E2|Reported Event|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69465|NCT01756157|E1|Reported Event|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
69466|NCT01756079|B1|Baseline|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
69493|NCT01755702|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
69524|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
109256|NCT01548287|E3|Reported Event|AZD5213 Dose C|AZD5213 6.0 mg daily
69467|NCT01756079|P1|Participant Flow|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
69468|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
69469|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
69470|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
69471|NCT01756079|E1|Reported Event|Overall Participants: Lead-in, Treatment and Follow-up|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
69472|NCT01756053|B1|Baseline|All Study Subjects|Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
69473|NCT01756053|P2|Participant Flow|Placebo, Then ABT-089|"Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.~Placebo: Matching placebo capsules supplied by study drug supplier."
69474|NCT01756053|P1|Participant Flow|ABT-089, Then Placebo|"Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
69475|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69476|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69477|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69478|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69479|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69480|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69481|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69482|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69483|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69484|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69485|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69486|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69487|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69488|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69489|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69490|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
69491|NCT01756053|E2|Reported Event|Placebo|"Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.~Placebo: Matched placebo capsules supplied by study drug supplier."
69623|NCT01755026|E2|Reported Event|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
69494|NCT01755702|P1|Participant Flow|Overall|"In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.~The following treatments were administered during the study.~1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.~1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.~400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.~placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water."
69495|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69496|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69497|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69498|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69499|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69500|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69501|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69502|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69503|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69504|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69505|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69506|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69507|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69508|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69509|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69510|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69511|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69512|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69513|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69514|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69515|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69516|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69517|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69518|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69519|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69520|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69521|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69522|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69523|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69624|NCT01755026|E1|Reported Event|4 Gram Dose|4 gram dose of pre-operative prophylaxis
69525|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69526|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69527|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69528|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69529|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69530|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69531|NCT01755702|E4|Reported Event|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
69532|NCT01755702|E3|Reported Event|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69533|NCT01755702|E2|Reported Event|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
69534|NCT01755702|E1|Reported Event|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
69535|NCT01755637|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
69536|NCT01755637|P2|Participant Flow|Albendazole (Alcohol) First, Then Albendazole (Aqua)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods.
69537|NCT01755637|P1|Participant Flow|Albendazole (Aqua) First, Then Albendazole (Alcohol)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods.
69538|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole Sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
69539|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole Sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
69540|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
69541|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
69542|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
69543|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
69544|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
69545|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
69546|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
69547|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
69548|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
69549|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
69550|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
69551|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
69552|NCT01755637|E2|Reported Event|Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
69553|NCT01755637|E1|Reported Event|Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
69554|NCT01755455|B1|Baseline|All Study Participants|Includes those who started the study with First Intervention and those who started the study with Second Intervention
69555|NCT01755455|P2|Participant Flow|Ferrous Sulfate, Then Placebo|Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
69556|NCT01755455|P1|Participant Flow|Placebo, Then Ferrous Sulfate|Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.
69557|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
69558|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
69559|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
69560|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
69561|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
69562|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
69563|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
69564|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
69565|NCT01755455|E2|Reported Event|Ferrous Sulfate|Events observed among all participants while they were receiving ferrous sulfate.
69566|NCT01755455|E1|Reported Event|Placebo|Events observed among all participants while they were receiving placebo.
69567|NCT01755234|B3|Baseline|Total|Total of all reporting groups
69568|NCT01755234|B2|Baseline|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69569|NCT01755234|B1|Baseline|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69570|NCT01755234|P2|Participant Flow|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69571|NCT01755234|P1|Participant Flow|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69572|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69573|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69574|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69575|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69576|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69577|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69578|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69579|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69580|NCT01755234|E2|Reported Event|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
69581|NCT01755234|E1|Reported Event|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
69582|NCT01755169|B5|Baseline|Total|Total of all reporting groups
69583|NCT01755169|B4|Baseline|Placebo|Placebo
69584|NCT01755169|B3|Baseline|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69585|NCT01755169|B2|Baseline|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69586|NCT01755169|B1|Baseline|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69587|NCT01755169|P4|Participant Flow|Placebo|Placebo
69588|NCT01755169|P3|Participant Flow|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69625|NCT01754922|B3|Baseline|Total|Total of all reporting groups
109257|NCT01548287|E2|Reported Event|AZD5213 Dose B|AZD 5213 2.0 mg daily
69589|NCT01755169|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69590|NCT01755169|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69591|NCT01755169|O4|Outcome|Placebo|Placebo
69592|NCT01755169|O3|Outcome|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69593|NCT01755169|O2|Outcome|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69594|NCT01755169|O1|Outcome|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69595|NCT01755169|E4|Reported Event|Placebo|Placebo
69596|NCT01755169|E3|Reported Event|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69597|NCT01755169|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69598|NCT01755169|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
69599|NCT01755143|B3|Baseline|Total|Total of all reporting groups
69600|NCT01755143|B2|Baseline|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69601|NCT01755143|B1|Baseline|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69602|NCT01755143|P2|Participant Flow|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69603|NCT01755143|P1|Participant Flow|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69604|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69605|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69606|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69607|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69608|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69609|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69610|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69611|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69612|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69613|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69614|NCT01755143|E2|Reported Event|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
69615|NCT01755143|E1|Reported Event|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
69616|NCT01755026|B3|Baseline|Total|Total of all reporting groups
69617|NCT01755026|B2|Baseline|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
69618|NCT01755026|B1|Baseline|4 Gram Dose|4 gram dose of pre-operative prophylaxis
69619|NCT01755026|P2|Participant Flow|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
69620|NCT01755026|P1|Participant Flow|4 Gram Dose|4 gram dose of pre-operative prophylaxis
69621|NCT01755026|O2|Outcome|4 Gram Dose|4 gram dose of pre-operative prophylaxis
69622|NCT01755026|O1|Outcome|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
69628|NCT01754922|P2|Participant Flow|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
69629|NCT01754922|P1|Participant Flow|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69630|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
69631|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69632|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
69633|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69634|NCT01754922|O2|Outcome|Control|Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
69635|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69636|NCT01754922|E2|Reported Event|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
69637|NCT01754922|E1|Reported Event|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
69638|NCT01754766|B4|Baseline|Total|Total of all reporting groups
69639|NCT01754766|B3|Baseline|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69640|NCT01754766|B2|Baseline|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69641|NCT01754766|B1|Baseline|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69642|NCT01754766|P3|Participant Flow|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69643|NCT01754766|P2|Participant Flow|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69644|NCT01754766|P1|Participant Flow|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69645|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69646|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69647|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69648|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69649|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69650|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69651|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69652|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69653|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69654|NCT01754766|E3|Reported Event|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
69655|NCT01754766|E2|Reported Event|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
69656|NCT01754766|E1|Reported Event|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
69657|NCT01754714|B5|Baseline|Total|Total of all reporting groups
69658|NCT01754714|B4|Baseline|No Treatment|no study drug was administered
69659|NCT01754714|B3|Baseline|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69660|NCT01754714|B2|Baseline|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69661|NCT01754714|B1|Baseline|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69662|NCT01754714|P4|Participant Flow|No Treatment|No study drug was administered
69663|NCT01754714|P3|Participant Flow|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69664|NCT01754714|P2|Participant Flow|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69665|NCT01754714|P1|Participant Flow|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69666|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69667|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69668|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69669|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69670|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69671|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69672|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69673|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69674|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69675|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69676|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69677|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69678|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69679|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69680|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69681|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69682|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69683|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69684|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69685|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69686|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69687|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69688|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69689|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69690|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69691|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69692|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69693|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69694|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69695|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69696|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69697|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69698|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69699|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69700|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69701|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69702|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69703|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69704|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69705|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69706|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69707|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69708|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69709|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69710|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69711|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69712|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69713|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69714|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69715|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69716|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69717|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69718|NCT01754714|O4|Outcome|No Treatment|
69719|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69720|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69721|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69722|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69723|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69724|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69725|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69726|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
112209|NCT01534533|P2|Participant Flow|Lutein Group|20mg lutein per day
69727|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69728|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69729|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69730|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69731|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69732|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69733|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69734|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69735|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69736|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69737|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69738|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69739|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69740|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69741|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69742|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69743|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69744|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69745|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69746|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
69747|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69748|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69749|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69750|NCT01754714|E4|Reported Event|No Treatment|No study drug was administered
69751|NCT01754714|E3|Reported Event|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
69752|NCT01754714|E2|Reported Event|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
69753|NCT01754714|E1|Reported Event|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
69754|NCT01754623|B1|Baseline|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69755|NCT01754623|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69756|NCT01754623|O2|Outcome|Resection Group -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69757|NCT01754623|O1|Outcome|All Participants -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69758|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69759|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
69760|NCT01754623|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
70323|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
69761|NCT01754493|B1|Baseline|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69762|NCT01754493|P1|Participant Flow|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69763|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69764|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69765|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69766|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69767|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69768|NCT01754493|E1|Reported Event|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
69769|NCT01754480|B3|Baseline|Total|Total of all reporting groups
69770|NCT01754480|B2|Baseline|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69771|NCT01754480|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69772|NCT01754480|P2|Participant Flow|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69773|NCT01754480|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69774|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69775|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69776|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69777|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69778|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69779|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69780|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69781|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
70324|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
112998|NCT01530243|B3|Baseline|Tolterodine|Tolterodine: 2 mg daily
69782|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69783|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69784|NCT01754480|E2|Reported Event|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
69785|NCT01754480|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
69786|NCT01753856|B3|Baseline|Total|Total of all reporting groups
69787|NCT01753856|B2|Baseline|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69788|NCT01753856|B1|Baseline|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69789|NCT01753856|P2|Participant Flow|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69790|NCT01753856|P1|Participant Flow|Teriparatide|"Teriparatide: 20-microgram (µg) subcutaneous (SC) injection once daily for 6 months.~DEM: 150-milligram (mg) tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 milligrams per day (mg/day) administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 International Units per day (IU/day) administered orally for 6 months."
69791|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69792|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69793|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69794|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69795|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69844|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69845|NCT01753557|O1|Outcome|Treatment-Naïve|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69796|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69797|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69798|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69799|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69800|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69801|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69802|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69803|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69804|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69805|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69806|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69846|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69847|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69807|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69808|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69809|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69810|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69811|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69812|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69813|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69814|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69815|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69816|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69817|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69848|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69849|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
112999|NCT01530243|B2|Baseline|Terazosin|Terazosine: 2 mg BID
69818|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69819|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69820|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69821|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69822|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69823|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69824|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69825|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69826|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69827|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69828|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69850|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69851|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69829|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69830|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69831|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69832|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69833|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69834|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69835|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69836|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69837|NCT01753856|E2|Reported Event|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69838|NCT01753856|E1|Reported Event|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
69839|NCT01753557|B3|Baseline|Total|Total of all reporting groups
69840|NCT01753557|B2|Baseline|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69841|NCT01753557|B1|Baseline|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69842|NCT01753557|P2|Participant Flow|Treatment-Relapsed|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69843|NCT01753557|P1|Participant Flow|Treatment-Naive|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
74808|NCT01726023|B2|Baseline|Meropenem|Meropenem powder for solution for infusion 1000mg
69852|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69853|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69854|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69855|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69856|NCT01753557|E2|Reported Event|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69857|NCT01753557|E1|Reported Event|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
69858|NCT01753518|B3|Baseline|Total|Total of all reporting groups
69859|NCT01753518|B2|Baseline|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69860|NCT01753518|B1|Baseline|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69861|NCT01753518|P2|Participant Flow|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69862|NCT01753518|P1|Participant Flow|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69863|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69864|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69865|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69866|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69867|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69868|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69869|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69870|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69871|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69872|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69873|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69874|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69875|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69876|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69877|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69878|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69879|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69880|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69881|NCT01753518|E2|Reported Event|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
69882|NCT01753518|E1|Reported Event|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
69883|NCT01753323|B4|Baseline|Total|Total of all reporting groups
69884|NCT01753323|B3|Baseline|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69885|NCT01753323|B2|Baseline|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69886|NCT01753323|B1|Baseline|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69887|NCT01753323|P3|Participant Flow|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69888|NCT01753323|P2|Participant Flow|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69889|NCT01753323|P1|Participant Flow|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69890|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69891|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69892|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69893|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69894|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69895|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69896|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69897|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69898|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69899|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69900|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69901|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69902|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69903|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69904|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69905|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69906|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69907|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69908|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69909|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69910|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69911|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69912|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69913|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69914|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69915|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69916|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69917|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69918|NCT01753323|O3|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69919|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69920|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69921|NCT01753323|E3|Reported Event|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
69922|NCT01753323|E2|Reported Event|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
69923|NCT01753323|E1|Reported Event|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
69924|NCT01753115|B4|Baseline|Total|Total of all reporting groups
69925|NCT01753115|B3|Baseline|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
69926|NCT01753115|B2|Baseline|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69927|NCT01753115|B1|Baseline|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69928|NCT01753115|P3|Participant Flow|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
69929|NCT01753115|P2|Participant Flow|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69930|NCT01753115|P1|Participant Flow|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69931|NCT01753115|O2|Outcome|BioThrax Only (Arm 3)|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
69932|NCT01753115|O1|Outcome|BioThrax + Ciprofloxacin (Arms 1 + 2)|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69933|NCT01753115|O1|Outcome|Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69934|NCT01753115|E3|Reported Event|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
69935|NCT01753115|E2|Reported Event|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69936|NCT01753115|E1|Reported Event|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
69937|NCT01752907|B3|Baseline|Total|Total of all reporting groups
69938|NCT01752907|B2|Baseline|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69939|NCT01752907|B1|Baseline|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69940|NCT01752907|P2|Participant Flow|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69941|NCT01752907|P1|Participant Flow|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69942|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69943|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69944|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69945|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69946|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69947|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69948|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69949|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69950|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69951|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69952|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69953|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69954|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69955|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
70013|NCT01751308|B4|Baseline|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
69956|NCT01752907|E2|Reported Event|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69957|NCT01752907|E1|Reported Event|General Chemotherapy Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
69958|NCT01752855|B3|Baseline|Total|Total of all reporting groups
69959|NCT01752855|B2|Baseline|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69960|NCT01752855|B1|Baseline|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69961|NCT01752855|P2|Participant Flow|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69962|NCT01752855|P1|Participant Flow|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69963|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69964|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69965|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69966|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69967|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69968|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69969|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69970|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69971|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69972|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69973|NCT01752855|E2|Reported Event|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
69974|NCT01752855|E1|Reported Event|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week.
69975|NCT01751867|B3|Baseline|Total|Total of all reporting groups
69976|NCT01751867|B2|Baseline|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69977|NCT01751867|B1|Baseline|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69978|NCT01751867|P2|Participant Flow|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69979|NCT01751867|P1|Participant Flow|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69980|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69981|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69982|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69983|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69984|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
70014|NCT01751308|B3|Baseline|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
69985|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69986|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69987|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69988|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69989|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69990|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69991|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69992|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69993|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69994|NCT01751867|E2|Reported Event|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
69995|NCT01751867|E1|Reported Event|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
69996|NCT01751802|B3|Baseline|Total|Total of all reporting groups
69997|NCT01751802|B2|Baseline|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
69998|NCT01751802|B1|Baseline|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
69999|NCT01751802|P2|Participant Flow|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
70000|NCT01751802|P1|Participant Flow|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
70001|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime for 6 weeks~Placebo: Placebo for Ecopipam"
70002|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime for 6 weeks~Ecopipam: Antagonist of the dopamine D1 receptor"
70003|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
70004|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
70005|NCT01751802|O4|Outcome|Subject #4: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
70006|NCT01751802|O3|Outcome|Subject #3: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
70007|NCT01751802|O2|Outcome|Subject #2: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
70008|NCT01751802|O1|Outcome|Subject #1: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
70009|NCT01751802|E2|Reported Event|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
70010|NCT01751802|E1|Reported Event|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
70011|NCT01751308|B6|Baseline|Total|Total of all reporting groups
70012|NCT01751308|B5|Baseline|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70015|NCT01751308|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70016|NCT01751308|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70017|NCT01751308|P5|Participant Flow|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70018|NCT01751308|P4|Participant Flow|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70019|NCT01751308|P3|Participant Flow|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70020|NCT01751308|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70021|NCT01751308|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
70022|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70023|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70024|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70025|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
70026|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70027|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70028|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70029|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
70030|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
70031|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70032|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70033|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
70034|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70035|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70036|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70037|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
70038|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70039|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70040|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70041|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70042|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70043|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70044|NCT01751308|O5|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70045|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70046|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70047|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70048|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
113003|NCT01530243|P2|Participant Flow|Terazosin|Terazosin: 2 mg BID
70049|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70050|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70051|NCT01751308|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70052|NCT01751308|E5|Reported Event|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70053|NCT01751308|E4|Reported Event|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70054|NCT01751308|E3|Reported Event|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70055|NCT01751308|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70056|NCT01751308|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
70057|NCT01751178|B4|Baseline|Total|Total of all reporting groups
70058|NCT01751178|B3|Baseline|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
70059|NCT01751178|B2|Baseline|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70060|NCT01751178|B1|Baseline|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70061|NCT01751178|P3|Participant Flow|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
70062|NCT01751178|P2|Participant Flow|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70063|NCT01751178|P1|Participant Flow|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70064|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
70065|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70066|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70067|NCT01751178|O3|Outcome|Reference|Brusing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
70068|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70069|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70070|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks
70071|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70072|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70073|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
70074|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70075|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70076|NCT01751178|E3|Reported Event|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
70077|NCT01751178|E2|Reported Event|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70078|NCT01751178|E1|Reported Event|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
70090|NCT01751113|O2|Outcome|Tio 18 µg BID|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70127|NCT01751087|P2|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70079|NCT01751113|B1|Baseline|Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|All participants received one of the following 3 treatments in one of three 4-week treatment periods separated by a 2-week washout period:Ado 50/250 µg BID (morning and evening) + Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) + Tio matching placebo QD (morning), and Tio 18 µg QD (morning) + Ado matching placebo BID (morning and evening). Participants were randomized to one of the 6 following treatment sequences: (1) Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg (2) Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg (3) Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg (4) Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg (5) Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg (6) Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg. Ado 50/250 µg and its matching placebo were administered via DISKUS inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants used salbutamol inhaler as relief medication throughout the study.
70080|NCT01751113|P6|Participant Flow|Sequence 6: Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
70081|NCT01751113|P5|Participant Flow|Sequence 5: Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|Participants received Ado 50/250 µg BID plus Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
70082|NCT01751113|P4|Participant Flow|Sequence 4: Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70083|NCT01751113|P3|Participant Flow|Sequence 3: Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70084|NCT01751113|P2|Participant Flow|Sequence 2: Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70085|NCT01751113|P1|Participant Flow|Sequence 1: Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg|Participants received salmeterol xinafoate/fluticasone propionate (Ado) 50/250 micrograms (µg) twice daily (BID) (morning and evening) plus tiotropium bromide (Tio) 18 µg once daily (QD) (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70086|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70087|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70088|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70089|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70128|NCT01751087|P1|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70091|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70092|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70093|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70094|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70095|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70096|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70097|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70098|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70099|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70100|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70101|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70102|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70103|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70104|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70105|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70106|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70107|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70187|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
70108|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70109|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70110|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70111|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70112|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70113|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70114|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70115|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70116|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70117|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70118|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70119|NCT01751113|E3|Reported Event|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70120|NCT01751113|E2|Reported Event|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70121|NCT01751113|E1|Reported Event|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
70122|NCT01751087|B4|Baseline|Total|Total of all reporting groups
70123|NCT01751087|B3|Baseline|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70124|NCT01751087|B2|Baseline|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70125|NCT01751087|B1|Baseline|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70126|NCT01751087|P3|Participant Flow|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
113007|NCT01530243|O2|Outcome|Terazosin|Terazosin: 2 mg BID
70129|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70130|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70131|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70132|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70133|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70134|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70135|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70136|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70137|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70138|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70139|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70140|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70141|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70142|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70143|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70144|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70145|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70146|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70147|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70148|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70149|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70150|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70188|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
70151|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70152|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70153|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70154|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70155|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70156|NCT01751087|E3|Reported Event|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
70157|NCT01751087|E2|Reported Event|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
70158|NCT01751087|E1|Reported Event|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
70159|NCT01751022|B4|Baseline|Total|Total of all reporting groups
70160|NCT01751022|B3|Baseline|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
70161|NCT01751022|B2|Baseline|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
70162|NCT01751022|B1|Baseline|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
70163|NCT01751022|P3|Participant Flow|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
70164|NCT01751022|P2|Participant Flow|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
70165|NCT01751022|P1|Participant Flow|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
70166|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
70167|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
70168|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
70169|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
70170|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
70171|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
70172|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
70173|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
70174|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
70175|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
70176|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
70177|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
70178|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
70179|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
70180|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
70181|NCT01751022|O3|Outcome|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
70182|NCT01751022|O2|Outcome|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
70183|NCT01751022|O1|Outcome|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
70184|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
70185|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
70186|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
70360|NCT01748799|O4|Outcome|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
70189|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
70190|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
70191|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
70192|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
70193|NCT01751022|E3|Reported Event|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
70194|NCT01751022|E2|Reported Event|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
70195|NCT01751022|E1|Reported Event|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
70196|NCT01750840|B1|Baseline|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
70197|NCT01750840|P1|Participant Flow|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
70198|NCT01750840|O1|Outcome|Stimulation Group|"All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.~Biomet EBI Bone Healing System: A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.~Biomet Orthopak Non-Invasive Bone Growth Stimulator: A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.~Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System: A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day."
70199|NCT01750840|O1|Outcome|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
70200|NCT01750840|E1|Reported Event|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
70201|NCT01750684|B3|Baseline|Total|Total of all reporting groups
70202|NCT01750684|B2|Baseline|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
70203|NCT01750684|B1|Baseline|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
70204|NCT01750684|P2|Participant Flow|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
70205|NCT01750684|P1|Participant Flow|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
70206|NCT01750684|O2|Outcome|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
70207|NCT01750684|O1|Outcome|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
70208|NCT01750684|E2|Reported Event|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
70209|NCT01750684|E1|Reported Event|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
70210|NCT01750502|B3|Baseline|Total|Total of all reporting groups
70211|NCT01750502|B2|Baseline|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70212|NCT01750502|B1|Baseline|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70213|NCT01750502|P2|Participant Flow|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70214|NCT01750502|P1|Participant Flow|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70215|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70216|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70217|NCT01750502|O2|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70218|NCT01750502|O1|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70219|NCT01750502|O3|Outcome|5 Minutes After the Opening of the Balloon|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70220|NCT01750502|O2|Outcome|After Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
70221|NCT01750502|O1|Outcome|Before Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
70222|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70223|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70224|NCT01750502|E2|Reported Event|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
70225|NCT01750502|E1|Reported Event|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
70226|NCT01750398|B1|Baseline|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70227|NCT01750398|P1|Participant Flow|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70228|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70229|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70230|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70251|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70252|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
74901|NCT01725984|B2|Baseline|AdVance XP|Subjects previously implanted with the AdVance XP male sling
70231|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70232|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70233|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70234|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70235|NCT01750398|E1|Reported Event|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
70236|NCT01750346|B4|Baseline|Total|Total of all reporting groups
70237|NCT01750346|B3|Baseline|Placebo|Participants in the Placebo arm received the placebo.
70238|NCT01750346|B2|Baseline|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70239|NCT01750346|B1|Baseline|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70240|NCT01750346|P3|Participant Flow|Placebo|Participants in the Placebo arm received the placebo.
70241|NCT01750346|P2|Participant Flow|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70242|NCT01750346|P1|Participant Flow|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70243|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70244|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70245|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70246|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70247|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70248|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70249|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70250|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70253|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70254|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70255|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70256|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70257|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70258|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70259|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70260|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70261|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
70262|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70263|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
70264|NCT01750346|E3|Reported Event|Placebo|"Participants in the Placebo arm received the placebo.~Topical acetyl hexapeptide-8"
70265|NCT01750346|E2|Reported Event|0.025% AH-8|"Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
70266|NCT01750346|E1|Reported Event|0.05% AH-8|"Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
70267|NCT01750294|B1|Baseline|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
70268|NCT01750294|P1|Participant Flow|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
70269|NCT01750294|O1|Outcome|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
70270|NCT01750294|E1|Reported Event|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
70271|NCT01750255|B3|Baseline|Total|Total of all reporting groups
70272|NCT01750255|B2|Baseline|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder.
70273|NCT01750255|B1|Baseline|Control|"There is no placebo treatment, and after randomization, patients were informed of their group assignments. The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families."
70274|NCT01750255|P2|Participant Flow|Intervention Group: the Dader Method for Pharmaceutical Care|The Dader Method for pharmaceutical care is a systematic process developed by the Research Group of Pharmaceutical Care at the University of Granada, Spain [16]. The intervention is based on the use of pharmacotherapy records, evaluation of an assessment form that includes BD-I and the drugs used to treat this medical problem, and their assessment on a specific date. This assessment is used to identify: (1) any potential or actual patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use of medicines (negative outcomes associated with medication (NOM)); and (2) situations in which the use of medicines caused or may cause the appearance of a NOM (drug-related problems (DRP)) [14]. Once the relevant problems are identified, the necessary interventions to patients or to physicians are carried out to solve the identified NOM and are followed by a subsequent assessment of the achieved outcomes.
70275|NCT01750255|P1|Participant Flow|Control: Usual Care (Routine Dispensing), Verbal and Written|Because there is no blinding, there is no ‘placebo’ treatment. Patients who meet the inclusion criteria will be informed about the study and they will be registered after their signed authorization. The control group (patients and their families) will receive usual care as well as verbal and written information provided by the pharmacist (routine dispensing, including oral counseling regarding drugs). The written material is about mental health (MH) and BD, with information focusing on the importance of adhering to pharmacological and non-pharmacological interventions to achieve treatment goals. Randomization will take place during week zero (baseline) and patients will meet again with the pharmacist every three months (3, 6, 9, and 12 months). At each appointment, variables related to the primary (number of hospitalizations, emergency service consultations, unscheduled outpatient visits) and secondary outcomes (effectiveness, safety, adherence, and quality of life) will be assessed.
70315|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
70316|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
70276|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70277|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70278|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70279|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70280|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70281|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70282|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70283|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70284|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70285|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70317|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70318|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
70319|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
70320|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
70321|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70286|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70287|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
70288|NCT01750255|E2|Reported Event|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
70289|NCT01750255|E1|Reported Event|Control|"The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure d"
70290|NCT01750242|B1|Baseline|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
70291|NCT01750242|P1|Participant Flow|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
70292|NCT01750242|O1|Outcome|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
70293|NCT01750242|O1|Outcome|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
70294|NCT01750242|E1|Reported Event|Subjects With Advanced Parkinson's Disease|The study protocol did not require safety data to be collected for the study.
70295|NCT01750086|B3|Baseline|Total|Total of all reporting groups
70296|NCT01750086|B2|Baseline|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70297|NCT01750086|B1|Baseline|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70298|NCT01750086|P2|Participant Flow|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70299|NCT01750086|P1|Participant Flow|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70300|NCT01750086|O2|Outcome|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70301|NCT01750086|O1|Outcome|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70302|NCT01750086|E2|Reported Event|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70303|NCT01750086|E1|Reported Event|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
70304|NCT01749982|B5|Baseline|Total|Total of all reporting groups
70305|NCT01749982|B4|Baseline|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70306|NCT01749982|B3|Baseline|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
70307|NCT01749982|B2|Baseline|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
70308|NCT01749982|B1|Baseline|Placebo|"Placebo tablets~Placebo"
70309|NCT01749982|P4|Participant Flow|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70310|NCT01749982|P3|Participant Flow|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
70311|NCT01749982|P2|Participant Flow|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
70312|NCT01749982|P1|Participant Flow|Placebo|"Placebo tablets~Placebo"
70313|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70314|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
70325|NCT01749982|E4|Reported Event|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
70326|NCT01749982|E3|Reported Event|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
70327|NCT01749982|E2|Reported Event|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
70328|NCT01749982|E1|Reported Event|Placebo|"Placebo tablets~Placebo"
70329|NCT01749956|B1|Baseline|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70330|NCT01749956|P1|Participant Flow|FOLFOX6/Aflibercept/Radation/Surgery|"Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle."
70331|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70332|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70333|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70334|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70335|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70336|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70337|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
70338|NCT01749956|E1|Reported Event|FOLFOX6/Aflibercept/Radiation/Surgery|"Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept Treatments:~Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.~Modified FOLFOX6:~Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.~Radiation~Aflibercept~Surgery: Abdominoperineal or low anterior resectio"
70339|NCT01748799|B9|Baseline|Total|Total of all reporting groups
70340|NCT01748799|B8|Baseline|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
70341|NCT01748799|B7|Baseline|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
70342|NCT01748799|B6|Baseline|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
70343|NCT01748799|B5|Baseline|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
70344|NCT01748799|B4|Baseline|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
70345|NCT01748799|B3|Baseline|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
70346|NCT01748799|B2|Baseline|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
70347|NCT01748799|B1|Baseline|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
70348|NCT01748799|P8|Participant Flow|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
70349|NCT01748799|P7|Participant Flow|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
70350|NCT01748799|P6|Participant Flow|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
70351|NCT01748799|P5|Participant Flow|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
70352|NCT01748799|P4|Participant Flow|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
70353|NCT01748799|P3|Participant Flow|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
70354|NCT01748799|P2|Participant Flow|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
70355|NCT01748799|P1|Participant Flow|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
70356|NCT01748799|O8|Outcome|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated Placebo
70357|NCT01748799|O7|Outcome|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
70358|NCT01748799|O6|Outcome|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed Placebo
70359|NCT01748799|O5|Outcome|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
70361|NCT01748799|O3|Outcome|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
70362|NCT01748799|O2|Outcome|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
70363|NCT01748799|O1|Outcome|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
70364|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
70365|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
70366|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
70367|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
70368|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
70369|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
70370|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
70371|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
70372|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
70373|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
70374|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
70375|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
70376|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
70377|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
70378|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
70379|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
70380|NCT01748799|E8|Reported Event|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated placebo
70381|NCT01748799|E7|Reported Event|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
70382|NCT01748799|E6|Reported Event|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed placebo
70383|NCT01748799|E5|Reported Event|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
70384|NCT01748799|E4|Reported Event|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
70385|NCT01748799|E3|Reported Event|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
70386|NCT01748799|E2|Reported Event|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
70387|NCT01748799|E1|Reported Event|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
70388|NCT01748760|B3|Baseline|Total|Total of all reporting groups
70389|NCT01748760|B2|Baseline|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
70390|NCT01748760|B1|Baseline|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
70391|NCT01748760|P2|Participant Flow|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
70392|NCT01748760|P1|Participant Flow|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
70393|NCT01748760|O2|Outcome|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
70394|NCT01748760|O1|Outcome|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
70395|NCT01748760|E2|Reported Event|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
70396|NCT01748760|E1|Reported Event|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
74902|NCT01725984|B1|Baseline|AdVance|Subjects previously implanted with the AdVance Male Sling
70397|NCT01749631|B1|Baseline|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70398|NCT01749631|P1|Participant Flow|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70399|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70400|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70401|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70402|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70403|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70404|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70405|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70406|NCT01749631|E1|Reported Event|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
70407|NCT01749501|B3|Baseline|Total|Total of all reporting groups
70408|NCT01749501|B2|Baseline|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
70409|NCT01749501|B1|Baseline|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
70410|NCT01749501|P2|Participant Flow|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
70411|NCT01749501|P1|Participant Flow|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
70412|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
70413|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
70414|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
70415|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
70416|NCT01749501|E2|Reported Event|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
70417|NCT01749501|E1|Reported Event|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
70418|NCT01749410|B1|Baseline|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
70419|NCT01749410|P1|Participant Flow|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
70420|NCT01749410|O1|Outcome|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
70421|NCT01749410|E1|Reported Event|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
70422|NCT01748955|B3|Baseline|Total|Total of all reporting groups
70423|NCT01748955|B2|Baseline|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
70424|NCT01748955|B1|Baseline|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
70425|NCT01748955|P2|Participant Flow|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
70426|NCT01748955|P1|Participant Flow|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
70427|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
70428|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
70734|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70429|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
70430|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
70431|NCT01748955|E2|Reported Event|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
70432|NCT01748955|E1|Reported Event|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
70433|NCT01748916|B1|Baseline|All Groups (Average)|All study participants
70434|NCT01748916|P6|Participant Flow|Carrot-Tomato-Papaya|"Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70435|NCT01748916|P5|Participant Flow|Carrot-Papaya-Tomato|"Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70436|NCT01748916|P4|Participant Flow|Tomato-Carrot-Papaya|"Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70437|NCT01748916|P3|Participant Flow|Tomato-Papaya-Carrot|"Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70438|NCT01748916|P2|Participant Flow|Papaya-Tomato-Carrot|"Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70439|NCT01748916|P1|Participant Flow|Papaya-Carrot-Tomato|"Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
70440|NCT01748916|O5|Outcome|Lycopene Absorption From Tomato|
70441|NCT01748916|O4|Outcome|Lycopene Absorption From Papaya|
70442|NCT01748916|O3|Outcome|Beta-Carotene Absorption From Carrot|
70443|NCT01748916|O2|Outcome|Beta-Carotene Absorption From Tomato|
70444|NCT01748916|O1|Outcome|Beta-Carotene Absorption From Papaya|
70445|NCT01748916|E1|Reported Event|All Groups|All groups in study
70446|NCT01748890|B1|Baseline|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
70447|NCT01748890|P1|Participant Flow|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
70448|NCT01748890|O1|Outcome|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
70449|NCT01748890|E1|Reported Event|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
70450|NCT01748227|B1|Baseline|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
70735|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
74916|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
70451|NCT01748227|P1|Participant Flow|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
70452|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
70453|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
70454|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
70455|NCT01748227|O1|Outcome|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
70456|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
70457|NCT01748227|E1|Reported Event|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
70458|NCT01748071|B4|Baseline|Total|Total of all reporting groups
70459|NCT01748071|B3|Baseline|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70460|NCT01748071|B2|Baseline|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70461|NCT01748071|B1|Baseline|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70462|NCT01748071|P3|Participant Flow|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70463|NCT01748071|P2|Participant Flow|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70464|NCT01748071|P1|Participant Flow|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70465|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70466|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70467|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70468|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70469|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70470|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70471|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70472|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70473|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70474|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70475|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70476|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70477|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70478|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70479|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70480|NCT01748071|E3|Reported Event|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
70481|NCT01748071|E2|Reported Event|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
70482|NCT01748071|E1|Reported Event|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
70483|NCT01747928|B9|Baseline|Total|Total of all reporting groups
70484|NCT01747928|B8|Baseline|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70485|NCT01747928|B7|Baseline|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70486|NCT01747928|B6|Baseline|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70487|NCT01747928|B5|Baseline|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70488|NCT01747928|B4|Baseline|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70736|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70489|NCT01747928|B3|Baseline|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70490|NCT01747928|B2|Baseline|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70491|NCT01747928|B1|Baseline|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70492|NCT01747928|P8|Participant Flow|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70493|NCT01747928|P7|Participant Flow|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70494|NCT01747928|P6|Participant Flow|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70495|NCT01747928|P5|Participant Flow|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70496|NCT01747928|P4|Participant Flow|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70497|NCT01747928|P3|Participant Flow|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70498|NCT01747928|P2|Participant Flow|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70499|NCT01747928|P1|Participant Flow|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70500|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70501|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70502|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70503|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70504|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70505|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70506|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70507|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70508|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70509|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70510|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70511|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70512|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70513|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70514|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70515|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70516|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70517|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70518|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70519|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70520|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70521|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70522|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70523|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70524|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70525|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70526|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70527|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70528|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70529|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70530|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70531|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70532|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70533|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70534|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70535|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70536|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70537|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70538|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70539|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70540|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70541|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70542|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70543|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70544|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70545|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70546|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70547|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70548|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70549|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70550|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70551|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70552|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70553|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70554|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70555|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70556|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70557|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70558|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70559|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70560|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70561|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70562|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70563|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70564|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70565|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70566|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70567|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70568|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70569|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70570|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70571|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70572|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70573|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70574|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70575|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70576|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70577|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70578|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70579|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70580|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70581|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70582|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70583|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70584|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70585|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70586|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70587|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70588|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70589|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70590|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70591|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70592|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70593|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70594|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70595|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70596|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70597|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70598|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70599|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70600|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70601|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70602|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70603|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70604|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70605|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70606|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70607|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70608|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70609|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70610|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70611|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70612|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70613|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70614|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70615|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70616|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70617|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70618|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70619|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70620|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70621|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70622|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70623|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70624|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70625|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70626|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70627|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70628|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70629|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70630|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70631|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70632|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70633|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70634|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70635|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70636|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70637|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70638|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70639|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70640|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70641|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70642|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70643|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70644|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70645|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70646|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70647|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70648|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70649|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70650|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70651|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70652|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70653|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70654|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70655|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70656|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70657|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70658|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70659|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70660|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70661|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70662|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70663|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70664|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70665|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70666|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70667|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70668|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70669|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70670|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70671|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70672|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70673|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70674|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70675|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70676|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
70677|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70678|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70679|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70680|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70681|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70682|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70683|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70684|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70685|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
70686|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70687|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70688|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70689|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70690|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70691|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70692|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70693|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70694|NCT01747928|E8|Reported Event|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70695|NCT01747928|E7|Reported Event|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70737|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70696|NCT01747928|E6|Reported Event|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70697|NCT01747928|E5|Reported Event|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70698|NCT01747928|E4|Reported Event|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70699|NCT01747928|E3|Reported Event|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70700|NCT01747928|E2|Reported Event|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70701|NCT01747928|E1|Reported Event|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
70702|NCT01747811|B3|Baseline|Total|Total of all reporting groups
70703|NCT01747811|B2|Baseline|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70704|NCT01747811|B1|Baseline|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70705|NCT01747811|P2|Participant Flow|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70706|NCT01747811|P1|Participant Flow|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
70707|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70708|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
70709|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70710|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70711|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70712|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70713|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70714|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
70715|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70716|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70717|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70718|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
70719|NCT01747811|E2|Reported Event|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
70720|NCT01747811|E1|Reported Event|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
70721|NCT01747655|B1|Baseline|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70722|NCT01747655|P2|Participant Flow|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70723|NCT01747655|P1|Participant Flow|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70724|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70725|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70726|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70727|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70728|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70729|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70730|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70731|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70732|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70733|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70816|NCT01746940|E2|Reported Event|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
70738|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70739|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70740|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70741|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70742|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70743|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70744|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70745|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications.
70746|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70747|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
70748|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
70749|NCT01747655|E1|Reported Event|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
70750|NCT01747629|B3|Baseline|Total|Total of all reporting groups
70751|NCT01747629|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70752|NCT01747629|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70753|NCT01747629|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70754|NCT01747629|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70755|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70756|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70757|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70758|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70759|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70760|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70761|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70762|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70763|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70764|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70765|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70766|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70767|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70768|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70769|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70770|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70771|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70772|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70773|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70774|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70817|NCT01746940|E1|Reported Event|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
70775|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70776|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70777|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70778|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70779|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70780|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70781|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70782|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70783|NCT01747629|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
70784|NCT01747629|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
70785|NCT01747343|B1|Baseline|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70786|NCT01747343|P1|Participant Flow|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70787|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70788|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70789|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70790|NCT01747343|E1|Reported Event|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
70791|NCT01747330|B1|Baseline|Creon Micro, Minimicrospheres|Pancreatin: Doses of pancreatin <2500 lipase u/kg/feed or <4000 lipase u/g fat/intake or <10000 lipase u/kg/day given orally are used
70792|NCT01747330|P1|Participant Flow|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70793|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70794|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70795|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70796|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70797|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70798|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70799|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70800|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70801|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70802|NCT01747330|E1|Reported Event|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
70803|NCT01746940|B5|Baseline|Total|Total of all reporting groups
70804|NCT01746940|B4|Baseline|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
70805|NCT01746940|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
70806|NCT01746940|B2|Baseline|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
70807|NCT01746940|B1|Baseline|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
70808|NCT01746940|P4|Participant Flow|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
70809|NCT01746940|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
70810|NCT01746940|P2|Participant Flow|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
70811|NCT01746940|P1|Participant Flow|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
70812|NCT01746940|O3|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
70813|NCT01746940|O2|Outcome|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
70814|NCT01746940|O1|Outcome|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
70815|NCT01746940|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
70819|NCT01746862|B2|Baseline|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70820|NCT01746862|B1|Baseline|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70821|NCT01746862|P2|Participant Flow|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70822|NCT01746862|P1|Participant Flow|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70823|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70824|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70825|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70826|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70827|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70828|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70829|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70830|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70831|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70832|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70833|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70834|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70835|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70836|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70837|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70838|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70839|NCT01746862|E2|Reported Event|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
70840|NCT01746862|E1|Reported Event|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
70841|NCT01746784|B6|Baseline|Total|Total of all reporting groups
70842|NCT01746784|B5|Baseline|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70843|NCT01746784|B4|Baseline|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70844|NCT01746784|B3|Baseline|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70845|NCT01746784|B2|Baseline|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70846|NCT01746784|B1|Baseline|Normal Saline|Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
70847|NCT01746784|P5|Participant Flow|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70848|NCT01746784|P4|Participant Flow|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70849|NCT01746784|P3|Participant Flow|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70850|NCT01746784|P2|Participant Flow|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70851|NCT01746784|P1|Participant Flow|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
70852|NCT01746784|O5|Outcome|40mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022 in normal saline administered by infusion pump over 1-8 minutes"
70853|NCT01746784|O4|Outcome|20mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
70854|NCT01746784|O3|Outcome|10mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
70855|NCT01746784|O2|Outcome|5mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
70856|NCT01746784|O1|Outcome|Normal Saline|Placebo will receive IV normal saline Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl
70857|NCT01746784|O5|Outcome|40mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70858|NCT01746784|O4|Outcome|20mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70859|NCT01746784|O3|Outcome|10mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70860|NCT01746784|O2|Outcome|5mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70861|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
70862|NCT01746784|O5|Outcome|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70863|NCT01746784|O4|Outcome|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70864|NCT01746784|O3|Outcome|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70865|NCT01746784|O2|Outcome|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
70866|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
70867|NCT01746784|E5|Reported Event|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70868|NCT01746784|E4|Reported Event|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70869|NCT01746784|E3|Reported Event|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70870|NCT01746784|E2|Reported Event|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
70871|NCT01746784|E1|Reported Event|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
70872|NCT01746511|B3|Baseline|Total|Total of all reporting groups
70873|NCT01746511|B2|Baseline|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70874|NCT01746511|B1|Baseline|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
70875|NCT01746511|P2|Participant Flow|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70876|NCT01746511|P1|Participant Flow|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70900|NCT01746264|B1|Baseline|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70901|NCT01746264|P1|Participant Flow|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70877|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70878|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70879|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70880|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70881|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70882|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70883|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70884|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70885|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70886|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
70887|NCT01746511|E2|Reported Event|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
70888|NCT01746511|E1|Reported Event|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
70889|NCT01746368|B3|Baseline|Total|Total of all reporting groups
70890|NCT01746368|B2|Baseline|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
70891|NCT01746368|B1|Baseline|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
70892|NCT01746368|P2|Participant Flow|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
70893|NCT01746368|P1|Participant Flow|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
70894|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
70895|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
70896|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
70897|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
70898|NCT01746368|E2|Reported Event|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
70899|NCT01746368|E1|Reported Event|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
70902|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70903|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70904|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70905|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70906|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70907|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70908|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70909|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70910|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70911|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70912|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70913|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70914|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70915|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70916|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70917|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70918|NCT01746264|E1|Reported Event|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
70919|NCT01746173|B1|Baseline|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
70920|NCT01746173|P1|Participant Flow|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
70921|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
70922|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
70923|NCT01746173|E1|Reported Event|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
70924|NCT01746108|B4|Baseline|Total|Total of all reporting groups
71016|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
70925|NCT01746108|B3|Baseline|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70926|NCT01746108|B2|Baseline|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70927|NCT01746108|B1|Baseline|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70928|NCT01746108|P3|Participant Flow|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70929|NCT01746108|P2|Participant Flow|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70930|NCT01746108|P1|Participant Flow|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70931|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70932|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70933|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70934|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70935|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70936|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70937|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70938|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70939|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70940|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
70941|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
70942|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
70943|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
70944|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70945|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
70946|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
70970|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
71132|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
70947|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70948|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
70949|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
70950|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
70951|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
70952|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70953|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
70954|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
70955|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70956|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70957|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70958|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70959|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70971|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
71133|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
70960|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70961|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70962|NCT01746108|E3|Reported Event|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70963|NCT01746108|E2|Reported Event|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
70964|NCT01746108|E1|Reported Event|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
70965|NCT01745952|B1|Baseline|All Participants|description of the patients at the onset of the study
70966|NCT01745952|P3|Participant Flow|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70967|NCT01745952|P2|Participant Flow|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70968|NCT01745952|P1|Participant Flow|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70969|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
71015|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
70972|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70973|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70974|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70975|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70976|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70977|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70978|NCT01745952|O1|Outcome|Any Difference Between the Four Conditions|effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
70979|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70980|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70981|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70982|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
70983|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
70984|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
70985|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70986|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
74917|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
70987|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
70988|NCT01745952|E3|Reported Event|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue"
70989|NCT01745952|E2|Reported Event|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil"
70990|NCT01745952|E1|Reported Event|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil"
70991|NCT01745380|B3|Baseline|Total|Total of all reporting groups
70992|NCT01745380|B2|Baseline|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
70993|NCT01745380|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
70994|NCT01745380|P2|Participant Flow|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
70995|NCT01745380|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
70996|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
70997|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
70998|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
70999|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71000|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71001|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71002|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71003|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71004|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71005|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71006|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71007|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71008|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71009|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71010|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71011|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71012|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71013|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71014|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71017|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71018|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71019|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71020|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71021|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71022|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71023|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71024|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71025|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71026|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71027|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71028|NCT01745380|E2|Reported Event|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
71029|NCT01745380|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
71030|NCT01745133|B4|Baseline|Total|Total of all reporting groups
71031|NCT01745133|B3|Baseline|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
71032|NCT01745133|B2|Baseline|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
71033|NCT01745133|B1|Baseline|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
71034|NCT01745133|P3|Participant Flow|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
71035|NCT01745133|P2|Participant Flow|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
71036|NCT01745133|P1|Participant Flow|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
71037|NCT01745133|O3|Outcome|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
71038|NCT01745133|O2|Outcome|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
71039|NCT01745133|O1|Outcome|Vehicle 68%|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
71040|NCT01745133|E3|Reported Event|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
71041|NCT01745133|E2|Reported Event|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
71134|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71042|NCT01745133|E1|Reported Event|Vehicle|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
71043|NCT01745055|B1|Baseline|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71044|NCT01745055|P1|Participant Flow|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71045|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71046|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71047|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71048|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71049|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71050|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71051|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71052|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71053|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71054|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71055|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71056|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71057|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71058|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71059|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71060|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71061|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71062|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71063|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71064|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71065|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71066|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71067|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71068|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
71069|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71070|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71071|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71072|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71073|NCT01745055|E3|Reported Event|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
71074|NCT01745055|E2|Reported Event|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
71075|NCT01745055|E1|Reported Event|Methotrexate|Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice.
71076|NCT01744977|B3|Baseline|Total|Total of all reporting groups
71077|NCT01744977|B2|Baseline|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
71099|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71100|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71078|NCT01744977|B1|Baseline|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
71079|NCT01744977|P2|Participant Flow|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
71080|NCT01744977|P1|Participant Flow|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
71081|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
71082|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
71083|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
71084|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
71085|NCT01744977|E2|Reported Event|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
71086|NCT01744977|E1|Reported Event|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
71087|NCT01744860|B1|Baseline|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
71088|NCT01744860|P1|Participant Flow|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
71089|NCT01744860|O1|Outcome|Final Result- Discordant Samples|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
71090|NCT01744860|O1|Outcome|Discordant Group|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
71091|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71092|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71093|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71094|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71095|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71096|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71097|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71098|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71166|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71101|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71102|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71103|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71104|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71105|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71106|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71107|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71108|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71109|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71110|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71111|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71112|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71113|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71114|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
71115|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
71116|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
71117|NCT01744860|O2|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71118|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
71119|NCT01744860|E2|Reported Event|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
71120|NCT01744860|E1|Reported Event|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods
71121|NCT01744821|B5|Baseline|Total|Total of all reporting groups
71122|NCT01744821|B4|Baseline|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71123|NCT01744821|B3|Baseline|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71124|NCT01744821|B2|Baseline|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71125|NCT01744821|B1|Baseline|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71126|NCT01744821|P4|Participant Flow|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71127|NCT01744821|P3|Participant Flow|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71128|NCT01744821|P2|Participant Flow|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71129|NCT01744821|P1|Participant Flow|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71130|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71131|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71165|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71135|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71136|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71137|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71138|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71139|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71140|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71141|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71142|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71143|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71144|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71145|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71146|NCT01744821|E4|Reported Event|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
71147|NCT01744821|E3|Reported Event|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
71148|NCT01744821|E2|Reported Event|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71149|NCT01744821|E1|Reported Event|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
71150|NCT01744730|B6|Baseline|Total|Total of all reporting groups
71151|NCT01744730|B5|Baseline|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
71152|NCT01744730|B4|Baseline|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71153|NCT01744730|B3|Baseline|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71154|NCT01744730|B2|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71155|NCT01744730|B1|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71156|NCT01744730|P5|Participant Flow|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration.
71157|NCT01744730|P4|Participant Flow|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71158|NCT01744730|P3|Participant Flow|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71159|NCT01744730|P2|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71160|NCT01744730|P1|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
71161|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71162|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71163|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71164|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71167|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71168|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71169|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71170|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71171|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71172|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71173|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71174|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71175|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71176|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71177|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71178|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71179|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71180|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71181|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71182|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71183|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71184|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71185|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71186|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71187|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71188|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71189|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71190|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71191|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71192|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71193|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71194|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71195|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
71196|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
71197|NCT01744730|E5|Reported Event|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
71198|NCT01744730|E4|Reported Event|Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
71199|NCT01744730|E3|Reported Event|Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
71200|NCT01744730|E2|Reported Event|Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
71201|NCT01744730|E1|Reported Event|Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
71202|NCT01744691|B1|Baseline|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
71203|NCT01744691|P1|Participant Flow|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
71204|NCT01744691|O1|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
71205|NCT01744691|O1|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
71206|NCT01744691|E1|Reported Event|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
71207|NCT01744496|B3|Baseline|Total|Total of all reporting groups
71208|NCT01744496|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71209|NCT01744496|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71210|NCT01744496|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71211|NCT01744496|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71212|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71213|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71214|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71215|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71245|NCT01744353|P3|Participant Flow|Experimental: Dose Level 3|Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
71216|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71217|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71218|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71219|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71220|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71221|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71222|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71223|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71224|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71225|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71226|NCT01744496|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71227|NCT01744496|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
71228|NCT01744392|B1|Baseline|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71229|NCT01744392|P1|Participant Flow|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71230|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71231|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71232|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71233|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71246|NCT01744353|P2|Participant Flow|Experimental: Dose Level 2/ MTD|Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
74918|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
71234|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71235|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71236|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71237|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71238|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
71239|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
71240|NCT01744392|E1|Reported Event|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
71241|NCT01744353|B4|Baseline|Total|Total of all reporting groups
71242|NCT01744353|B3|Baseline|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71243|NCT01744353|B2|Baseline|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71244|NCT01744353|B1|Baseline|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
74919|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
71247|NCT01744353|P1|Participant Flow|Experimental: Dose Level 1|Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
71248|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
71249|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71250|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71251|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
71252|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71253|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
71254|NCT01744353|E1|Reported Event|FOLFOX- A|"FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.~FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un"
71255|NCT01744340|B3|Baseline|Total|Total of all reporting groups
71256|NCT01744340|B2|Baseline|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71257|NCT01744340|B1|Baseline|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71258|NCT01744340|P2|Participant Flow|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71259|NCT01744340|P1|Participant Flow|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71260|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71261|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71262|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71263|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71264|NCT01744340|E2|Reported Event|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71265|NCT01744340|E1|Reported Event|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
71266|NCT01744197|B3|Baseline|Total|Total of all reporting groups
71267|NCT01744197|B2|Baseline|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
71369|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71268|NCT01744197|B1|Baseline|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
71269|NCT01744197|P2|Participant Flow|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
71270|NCT01744197|P1|Participant Flow|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
71271|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
71272|NCT01744197|O1|Outcome|Synera|Treated with Synera.
71273|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
71274|NCT01744197|O1|Outcome|Synera|Treated with Synera.
71275|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
71276|NCT01744197|O1|Outcome|Synera|Treated with Synera.
71277|NCT01744197|E2|Reported Event|Placebo|Treated with Placebo
71278|NCT01744197|E1|Reported Event|Synera|Treated with Synera.
71279|NCT01743963|B3|Baseline|Total|Total of all reporting groups
71280|NCT01743963|B2|Baseline|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
71281|NCT01743963|B1|Baseline|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
71282|NCT01743963|P2|Participant Flow|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
71283|NCT01743963|P1|Participant Flow|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
71284|NCT01743963|O2|Outcome|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
71285|NCT01743963|O1|Outcome|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
71286|NCT01743963|E2|Reported Event|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
71287|NCT01743963|E1|Reported Event|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
71288|NCT01743521|B5|Baseline|Total|Total of all reporting groups
71289|NCT01743521|B4|Baseline|No Group Allocated|Early treatment discontinuation or non-responder
71290|NCT01743521|B3|Baseline|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71291|NCT01743521|B2|Baseline|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71292|NCT01743521|B1|Baseline|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71293|NCT01743521|P4|Participant Flow|No Group Allocated|Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA)
71294|NCT01743521|P3|Participant Flow|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71295|NCT01743521|P2|Participant Flow|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71370|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71371|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
74920|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
71296|NCT01743521|P1|Participant Flow|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71297|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71298|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71299|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71300|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71301|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71302|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71303|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71304|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71305|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71306|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71372|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71373|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71307|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71308|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71309|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71310|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71311|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71312|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71313|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71314|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71315|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71316|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71317|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71374|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71375|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
74921|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
71318|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71319|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71320|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71321|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71322|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71323|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71324|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71325|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71326|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71327|NCT01743521|E3|Reported Event|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71328|NCT01743521|E2|Reported Event|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71376|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71377|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71329|NCT01743521|E1|Reported Event|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
71330|NCT01743092|B3|Baseline|Total|Total of all reporting groups
71331|NCT01743092|B2|Baseline|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
71332|NCT01743092|B1|Baseline|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
71333|NCT01743092|P2|Participant Flow|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
71334|NCT01743092|P1|Participant Flow|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
71335|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
71336|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
71337|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
71338|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
71339|NCT01743092|E2|Reported Event|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
71340|NCT01743092|E1|Reported Event|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
71341|NCT01743027|B5|Baseline|Total|Total of all reporting groups
71342|NCT01743027|B4|Baseline|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71343|NCT01743027|B3|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71344|NCT01743027|B2|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71345|NCT01743027|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71346|NCT01743027|P4|Participant Flow|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71347|NCT01743027|P3|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71348|NCT01743027|P2|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71349|NCT01743027|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71350|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71351|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71352|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71353|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71354|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71355|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71356|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71357|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71358|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71359|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71360|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71361|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71362|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71363|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71364|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71365|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71366|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71367|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71368|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71378|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71379|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71380|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71381|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71382|NCT01743027|E4|Reported Event|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71383|NCT01743027|E3|Reported Event|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71384|NCT01743027|E2|Reported Event|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71385|NCT01743027|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
71386|NCT01742936|B3|Baseline|Total|Total of all reporting groups
71387|NCT01742936|B2|Baseline|Cardiac Bypass|"Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
71388|NCT01742936|B1|Baseline|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
71389|NCT01742936|P2|Participant Flow|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
71390|NCT01742936|P1|Participant Flow|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
71391|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
71392|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
71393|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
71394|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
71395|NCT01742936|E2|Reported Event|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
71396|NCT01742936|E1|Reported Event|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
71397|NCT01742897|B1|Baseline|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
71398|NCT01742897|P1|Participant Flow|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
71399|NCT01742897|O1|Outcome|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
71400|NCT01742897|E1|Reported Event|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
71401|NCT01742364|B5|Baseline|Total|Total of all reporting groups
71402|NCT01742364|B4|Baseline|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71403|NCT01742364|B3|Baseline|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71404|NCT01742364|B2|Baseline|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71405|NCT01742364|B1|Baseline|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71406|NCT01742364|P4|Participant Flow|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71407|NCT01742364|P3|Participant Flow|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71408|NCT01742364|P2|Participant Flow|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71409|NCT01742364|P1|Participant Flow|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71410|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71411|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71412|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71413|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71414|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71415|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71416|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71417|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71418|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71419|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71420|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71421|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71422|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71423|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71424|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71425|NCT01742364|O1|Outcome|Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71426|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71427|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71428|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71429|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71430|NCT01742364|E4|Reported Event|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71431|NCT01742364|E3|Reported Event|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71432|NCT01742364|E2|Reported Event|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
71433|NCT01742364|E1|Reported Event|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
71434|NCT01741792|B4|Baseline|Total|Total of all reporting groups
71435|NCT01741792|B3|Baseline|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71436|NCT01741792|B2|Baseline|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71437|NCT01741792|B1|Baseline|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71438|NCT01741792|P3|Participant Flow|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71439|NCT01741792|P2|Participant Flow|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71440|NCT01741792|P1|Participant Flow|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71441|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71442|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71443|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71444|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71445|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71446|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71447|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71448|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71449|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71450|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71451|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71452|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71453|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71454|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71455|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71456|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71457|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71458|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71459|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71460|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71461|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71462|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71463|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71464|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71465|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71466|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71467|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71468|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71469|NCT01741792|O3|Outcome|Blinatumomab 112 μg/d|Participants received blinatumomab administered CIV 112 µg/day.
71470|NCT01741792|O2|Outcome|Blinatumomab 28 μg/d|Participants received blinatumomab CIV 28 µg/day.
71471|NCT01741792|O1|Outcome|Blinatumomab 9 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
71472|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71473|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71474|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71475|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71476|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71477|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71478|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71479|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71480|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71526|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71481|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71482|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71483|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71484|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71485|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71486|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71487|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71488|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71489|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71490|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71491|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71492|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71493|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71494|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71495|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71527|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71496|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71497|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71498|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71499|NCT01741792|E5|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
71500|NCT01741792|E4|Reported Event|Cohort 1+3: Blinatumomab 9/28/112µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71501|NCT01741792|E3|Reported Event|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71502|NCT01741792|E2|Reported Event|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71503|NCT01741792|E1|Reported Event|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
71504|NCT01741701|B3|Baseline|Total|Total of all reporting groups
71505|NCT01741701|B2|Baseline|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71506|NCT01741701|B1|Baseline|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71507|NCT01741701|P2|Participant Flow|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71508|NCT01741701|P1|Participant Flow|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71509|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71510|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71511|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71512|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71513|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71514|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71515|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71516|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71517|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71518|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71519|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71520|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71521|NCT01741701|E2|Reported Event|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
71522|NCT01741701|E1|Reported Event|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
71523|NCT01741688|B1|Baseline|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71524|NCT01741688|P1|Participant Flow|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71525|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71899|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
71528|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71529|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71530|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71531|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71532|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71533|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71534|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71535|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71536|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71537|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71538|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71539|NCT01741688|E1|Reported Event|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
71540|NCT01741350|B3|Baseline|Total|Total of all reporting groups
71541|NCT01741350|B2|Baseline|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71542|NCT01741350|B1|Baseline|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71543|NCT01741350|P2|Participant Flow|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71544|NCT01741350|P1|Participant Flow|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71545|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71546|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71547|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71548|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71549|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71550|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71551|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71690|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71691|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71692|NCT01741272|E2|Reported Event|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71552|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71553|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71554|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71555|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71556|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71557|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71558|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71559|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71693|NCT01741272|E1|Reported Event|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71694|NCT01740817|B1|Baseline|All Study Participants|Participants who were randomized to receive either lipid or saline
71695|NCT01740817|P2|Participant Flow|Saline Then Lipid|Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
71696|NCT01740817|P1|Participant Flow|Lipid Then Saline|Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
71697|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
71560|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71561|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71562|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71563|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71564|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71565|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71566|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71567|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71698|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
71699|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
71700|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
71701|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
71702|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
71703|NCT01740817|E2|Reported Event|Intralipid|Saline infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then Intralipid 30 ml/h for 48 h
71704|NCT01740817|E1|Reported Event|Saline|Intralipid infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then saline 30 ml/h for 48 h
71568|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71569|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71570|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71571|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71572|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71573|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71574|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71575|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71705|NCT01740726|B3|Baseline|Total|Total of all reporting groups
71706|NCT01740726|B2|Baseline|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
71750|NCT01740388|B2|Baseline|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71576|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71577|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71578|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71579|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71580|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71581|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71582|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71583|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71707|NCT01740726|B1|Baseline|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
71708|NCT01740726|P2|Participant Flow|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
71584|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71585|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71586|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71587|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71588|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71589|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71590|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71591|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71709|NCT01740726|P1|Participant Flow|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
71710|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
71592|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71593|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71594|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71595|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71596|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71597|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71598|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71599|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71711|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
71712|NCT01740726|E2|Reported Event|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
71600|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71601|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71602|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71603|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71604|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71605|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71606|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71607|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71713|NCT01740726|E1|Reported Event|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
71714|NCT01740713|B4|Baseline|Total|Total of all reporting groups
71715|NCT01740713|B3|Baseline|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71900|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
71608|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71609|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71610|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71611|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71612|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71613|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71614|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71615|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71716|NCT01740713|B2|Baseline|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71717|NCT01740713|B1|Baseline|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71718|NCT01740713|P3|Participant Flow|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71719|NCT01740713|P2|Participant Flow|Deferiprone 50 mg/kg/da|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71616|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71617|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71618|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71619|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71620|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71621|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71622|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71623|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71720|NCT01740713|P1|Participant Flow|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71721|NCT01740713|O1|Outcome|Safety Population|patients who may experience adverse events occurred before or after treatment
71722|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71723|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71624|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71625|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71626|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71627|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71628|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71629|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71630|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71631|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71724|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71725|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71726|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71727|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71632|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71633|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71634|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71635|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71636|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71637|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71638|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71639|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71728|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71729|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71730|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71731|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
71640|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71641|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71642|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71643|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71644|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71645|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71646|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71647|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71732|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71733|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71734|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71735|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
71648|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71649|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71650|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71651|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71652|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71653|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71654|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71655|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71736|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71737|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71738|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71739|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
71656|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71657|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71658|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71659|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71660|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71661|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71662|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71663|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71740|NCT01740713|E3|Reported Event|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
71741|NCT01740713|E2|Reported Event|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
71742|NCT01740713|E1|Reported Event|Deferiprone 25mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
71743|NCT01740440|B1|Baseline|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
71664|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71665|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71666|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71667|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71668|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71669|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71670|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71671|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71744|NCT01740440|P1|Participant Flow|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
71745|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
71746|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face: BMR Face used in accordance with manufacturer IFU"
71747|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
71748|NCT01740440|E1|Reported Event|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
71749|NCT01740388|B3|Baseline|Total|Total of all reporting groups
71672|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71673|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71674|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71675|NCT01741350|E2|Reported Event|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition: Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
71676|NCT01741350|E1|Reported Event|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program: Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
71677|NCT01741272|B3|Baseline|Total|Total of all reporting groups
71678|NCT01741272|B2|Baseline|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71679|NCT01741272|B1|Baseline|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71680|NCT01741272|P2|Participant Flow|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71681|NCT01741272|P1|Participant Flow|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71682|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71683|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71684|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71685|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71686|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71687|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
71688|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
71689|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
74922|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
71751|NCT01740388|B1|Baseline|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71752|NCT01740388|P2|Participant Flow|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71753|NCT01740388|P1|Participant Flow|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71754|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71755|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71756|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71757|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71758|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71759|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71760|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71761|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71762|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71763|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71764|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71765|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71766|NCT01740388|E2|Reported Event|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
71767|NCT01740388|E1|Reported Event|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
71768|NCT01740362|B5|Baseline|Total|Total of all reporting groups
71769|NCT01740362|B4|Baseline|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71770|NCT01740362|B3|Baseline|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71771|NCT01740362|B2|Baseline|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71772|NCT01740362|B1|Baseline|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71773|NCT01740362|P4|Participant Flow|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71774|NCT01740362|P3|Participant Flow|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71775|NCT01740362|P2|Participant Flow|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71776|NCT01740362|P1|Participant Flow|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71777|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71778|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71779|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71780|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71781|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71782|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71783|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71784|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71785|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71786|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71787|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71788|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71789|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71790|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71791|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71792|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71793|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71794|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71795|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71796|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71797|NCT01740362|E4|Reported Event|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71798|NCT01740362|E3|Reported Event|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71799|NCT01740362|E2|Reported Event|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
71800|NCT01740362|E1|Reported Event|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
71801|NCT01740089|B4|Baseline|Total|Total of all reporting groups
71802|NCT01740089|B3|Baseline|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
71803|NCT01740089|B2|Baseline|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71804|NCT01740089|B1|Baseline|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71805|NCT01740089|P3|Participant Flow|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
71806|NCT01740089|P2|Participant Flow|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71807|NCT01740089|P1|Participant Flow|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71808|NCT01740089|O2|Outcome|PegIntron (n=50)|
71809|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
71810|NCT01740089|O2|Outcome|PegIntron (n=50)|
71811|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
71812|NCT01740089|O2|Outcome|PegIntron (n=50)|
71813|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
71814|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
71815|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71816|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71817|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
71818|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71819|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
71820|NCT01740089|E2|Reported Event|PegIntron (n=50)|
71821|NCT01740089|E1|Reported Event|Algeron (n=101)|The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [severe depression by the Beck's scale before the first injection], who was withdrawn from the mITT-analysis)
71822|NCT01739803|B3|Baseline|Total|Total of all reporting groups
71823|NCT01739803|B2|Baseline|Control Group|No intervention
71824|NCT01739803|B1|Baseline|Intervention Group|Behavioral contract intervention
71825|NCT01739803|P2|Participant Flow|Control Group|"No intervention.~The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence packet consisting of adherence-focused educational pamphlets and a pillbox"
71861|NCT01738984|P1|Participant Flow|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71901|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
71826|NCT01739803|P1|Participant Flow|Intervention Group|"Behavioral contract intervention.~Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated.~The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence"
71827|NCT01739803|O2|Outcome|Control Group|No intervention
71828|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
71829|NCT01739803|O2|Outcome|Control Group|No intervention
71830|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
71831|NCT01739803|O2|Outcome|Control Group|No intervention
71832|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
71833|NCT01739803|E2|Reported Event|Control Group|No intervention
71834|NCT01739803|E1|Reported Event|Intervention Group|Behavioral contract intervention
71835|NCT01739595|B4|Baseline|Total|Total of all reporting groups
71836|NCT01739595|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
71837|NCT01739595|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71838|NCT01739595|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71839|NCT01739595|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
71840|NCT01739595|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71841|NCT01739595|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71842|NCT01739595|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
71843|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71844|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71845|NCT01739595|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
71846|NCT01739595|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71847|NCT01739595|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
71848|NCT01739361|B3|Baseline|Total|Total of all reporting groups
71849|NCT01739361|B2|Baseline|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
71850|NCT01739361|B1|Baseline|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
71851|NCT01739361|P2|Participant Flow|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
71852|NCT01739361|P1|Participant Flow|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
71853|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
71854|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
71855|NCT01739361|E2|Reported Event|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
71856|NCT01739361|E1|Reported Event|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
71857|NCT01738984|B3|Baseline|Total|Total of all reporting groups
71858|NCT01738984|B2|Baseline|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71859|NCT01738984|B1|Baseline|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71860|NCT01738984|P2|Participant Flow|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71862|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71902|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
71903|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
71863|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71864|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71865|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71866|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71867|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71868|NCT01738984|E2|Reported Event|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
71869|NCT01738984|E1|Reported Event|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
71870|NCT01738971|B4|Baseline|Total|Total of all reporting groups
71871|NCT01738971|B3|Baseline|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71872|NCT01738971|B2|Baseline|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71873|NCT01738971|B1|Baseline|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71874|NCT01738971|P3|Participant Flow|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71875|NCT01738971|P2|Participant Flow|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71876|NCT01738971|P1|Participant Flow|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71877|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71878|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71879|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71880|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71881|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71882|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71883|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71884|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71885|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71886|NCT01738971|E3|Reported Event|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
71887|NCT01738971|E2|Reported Event|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
71888|NCT01738971|E1|Reported Event|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
71889|NCT01738919|B3|Baseline|Total|Total of all reporting groups
71890|NCT01738919|B2|Baseline|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
71891|NCT01738919|B1|Baseline|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
71892|NCT01738919|P2|Participant Flow|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
71893|NCT01738919|P1|Participant Flow|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
71894|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
71895|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
71896|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
71897|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
71898|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
71904|NCT01738919|O2|Outcome|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
71905|NCT01738919|O1|Outcome|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
71906|NCT01738919|E2|Reported Event|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
71907|NCT01738919|E1|Reported Event|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
71908|NCT01738750|B3|Baseline|Total|Total of all reporting groups
71909|NCT01738750|B2|Baseline|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
71910|NCT01738750|B1|Baseline|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
71911|NCT01738750|P2|Participant Flow|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
71912|NCT01738750|P1|Participant Flow|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
71913|NCT01738750|O2|Outcome|No Dollar Information Included|Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
71914|NCT01738750|O1|Outcome|Dollar Information Included|"Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Dollars Information Included"
71915|NCT01738750|O2|Outcome|No Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
71916|NCT01738750|O1|Outcome|Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
71917|NCT01738750|E2|Reported Event|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
71918|NCT01738750|E1|Reported Event|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
71919|NCT01738737|B6|Baseline|Total|Total of all reporting groups
71920|NCT01738737|B5|Baseline|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71921|NCT01738737|B4|Baseline|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71922|NCT01738737|B3|Baseline|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71923|NCT01738737|B2|Baseline|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71924|NCT01738737|B1|Baseline|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71925|NCT01738737|P5|Participant Flow|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71926|NCT01738737|P4|Participant Flow|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)"
71927|NCT01738737|P3|Participant Flow|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71928|NCT01738737|P2|Participant Flow|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)"
71929|NCT01738737|P1|Participant Flow|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71930|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71931|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71932|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71933|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71934|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71935|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71968|NCT01738698|P1|Participant Flow|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71936|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71937|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71938|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71939|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71940|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71941|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71942|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71943|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71944|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71945|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71946|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71947|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71948|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71949|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71950|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71951|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71952|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71953|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71954|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71955|NCT01738737|E5|Reported Event|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
71956|NCT01738737|E4|Reported Event|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
71957|NCT01738737|E3|Reported Event|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71958|NCT01738737|E2|Reported Event|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
71959|NCT01738737|E1|Reported Event|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
71960|NCT01738698|B5|Baseline|Total|Total of all reporting groups
71961|NCT01738698|B4|Baseline|Placebo|Placebo: Oral administration once-daily for 12 weeks
71962|NCT01738698|B3|Baseline|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71963|NCT01738698|B2|Baseline|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71964|NCT01738698|B1|Baseline|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71965|NCT01738698|P4|Participant Flow|Placebo|Placebo: Oral administration once-daily for 12 weeks
71966|NCT01738698|P3|Participant Flow|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71967|NCT01738698|P2|Participant Flow|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71970|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71971|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71972|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71973|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71974|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71975|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71976|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71977|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71978|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71979|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71980|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71981|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71982|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71983|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71984|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71985|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71986|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71987|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71988|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71989|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71990|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71991|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71992|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71993|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71994|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71995|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
71996|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
71997|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
71998|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
71999|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72000|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72001|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72002|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72003|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72004|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72005|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72006|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72007|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72008|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72009|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72010|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72011|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72012|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72013|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72014|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72015|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72016|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72017|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72018|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72019|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72020|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72021|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72022|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72023|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72024|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72025|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
72026|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72027|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72028|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72030|NCT01738698|E3|Reported Event|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
72031|NCT01738698|E2|Reported Event|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
72032|NCT01738698|E1|Reported Event|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
72033|NCT01738646|B1|Baseline|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72034|NCT01738646|P1|Participant Flow|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72035|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72036|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72037|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72038|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|"Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.~Vorinostat~Bevacizumab"
72039|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
72040|NCT01738646|E1|Reported Event|Vorinostat & Bevacizumab|Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
72041|NCT01738581|B3|Baseline|Total|Total of all reporting groups
72042|NCT01738581|B2|Baseline|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
72043|NCT01738581|B1|Baseline|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
72044|NCT01738581|P2|Participant Flow|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
72045|NCT01738581|P1|Participant Flow|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
72046|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
72047|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
72048|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
72049|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
72050|NCT01738581|E2|Reported Event|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
72051|NCT01738581|E1|Reported Event|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
72052|NCT01738438|B1|Baseline|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72053|NCT01738438|P1|Participant Flow|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72054|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72055|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72056|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72057|NCT01738438|E1|Reported Event|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
72058|NCT01738321|B3|Baseline|Total|Total of all reporting groups
72059|NCT01738321|B2|Baseline|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72060|NCT01738321|B1|Baseline|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72061|NCT01738321|P2|Participant Flow|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72062|NCT01738321|P1|Participant Flow|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72063|NCT01738321|O2|Outcome|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72064|NCT01738321|O1|Outcome|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72065|NCT01738321|E2|Reported Event|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72066|NCT01738321|E1|Reported Event|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
72067|NCT01737996|B4|Baseline|Total|Total of all reporting groups
72068|NCT01737996|B3|Baseline|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72069|NCT01737996|B2|Baseline|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72070|NCT01737996|B1|Baseline|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72071|NCT01737996|P3|Participant Flow|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72072|NCT01737996|P2|Participant Flow|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
72073|NCT01737996|P1|Participant Flow|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
72074|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72075|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72076|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72077|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72078|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72079|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72080|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72081|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72082|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72083|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72084|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72085|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72086|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72087|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72088|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72089|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72090|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72091|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72092|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72093|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72094|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72095|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72096|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72097|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72098|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72099|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72100|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72101|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72102|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72103|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72104|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72105|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72106|NCT01737996|E3|Reported Event|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
72107|NCT01737996|E2|Reported Event|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
72108|NCT01737996|E1|Reported Event|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
72109|NCT01737944|B5|Baseline|Total|Total of all reporting groups
72110|NCT01737944|B4|Baseline|25mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
72111|NCT01737944|B3|Baseline|20mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
72112|NCT01737944|B2|Baseline|15mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
72113|NCT01737944|B1|Baseline|10mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
72114|NCT01737944|P4|Participant Flow|25mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
72115|NCT01737944|P3|Participant Flow|20mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
72116|NCT01737944|P2|Participant Flow|15mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
72117|NCT01737944|P1|Participant Flow|10mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
72118|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
72119|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
72120|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
72121|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
72122|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
72123|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
72124|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
72125|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
72126|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
72127|NCT01737944|E4|Reported Event|25mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
72128|NCT01737944|E3|Reported Event|20mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
72129|NCT01737944|E2|Reported Event|15mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
72130|NCT01737944|E1|Reported Event|10mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
72131|NCT01737931|B4|Baseline|Total|Total of all reporting groups
72132|NCT01737931|B3|Baseline|No-treatment|No treatment to the application sites after the patch removal
72133|NCT01737931|B2|Baseline|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72134|NCT01737931|B1|Baseline|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72135|NCT01737931|P3|Participant Flow|No-treatment|No treatment to the application sites after the patch removal
72136|NCT01737931|P2|Participant Flow|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72137|NCT01737931|P1|Participant Flow|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72138|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
72139|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72140|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72141|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
72142|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72143|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72144|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
72145|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72146|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72147|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
72148|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
72149|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
72150|NCT01737931|E1|Reported Event|Over-all|"In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.~Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group."
72151|NCT01737879|B1|Baseline|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72152|NCT01737879|P1|Participant Flow|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72153|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72154|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72155|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72156|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72157|NCT01737879|E1|Reported Event|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
72158|NCT01737840|B3|Baseline|Total|Total of all reporting groups
72159|NCT01737840|B2|Baseline|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
72160|NCT01737840|B1|Baseline|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
72161|NCT01737840|P2|Participant Flow|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
72162|NCT01737840|P1|Participant Flow|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
72163|NCT01737840|O2|Outcome|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
72164|NCT01737840|O1|Outcome|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
72165|NCT01737840|O2|Outcome|Ranitidine|Intravenous ranitidine 50 mg
72166|NCT01737840|O1|Outcome|Pantoprazole|Intravenous pantoprazole 40 mg
72167|NCT01737840|E2|Reported Event|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
72168|NCT01737840|E1|Reported Event|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
72169|NCT01737710|B6|Baseline|Total|Total of all reporting groups
72170|NCT01737710|B5|Baseline|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72384|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72171|NCT01737710|B4|Baseline|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
72172|NCT01737710|B3|Baseline|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72173|NCT01737710|B2|Baseline|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72174|NCT01737710|B1|Baseline|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72175|NCT01737710|P5|Participant Flow|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72176|NCT01737710|P4|Participant Flow|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
72177|NCT01737710|P3|Participant Flow|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72178|NCT01737710|P2|Participant Flow|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72179|NCT01737710|P1|Participant Flow|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72180|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72181|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72182|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72183|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72184|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72185|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72186|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72187|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72188|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72189|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72190|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72191|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72192|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72193|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72194|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72195|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72196|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72197|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72198|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72385|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72199|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72200|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72201|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72202|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72203|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72204|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72205|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72206|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72207|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72208|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72209|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72210|NCT01737710|E5|Reported Event|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72211|NCT01737710|E4|Reported Event|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
72212|NCT01737710|E3|Reported Event|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
72213|NCT01737710|E2|Reported Event|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72214|NCT01737710|E1|Reported Event|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
72215|NCT01737684|B3|Baseline|Total|Total of all reporting groups
72216|NCT01737684|B2|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72217|NCT01737684|B1|Baseline|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72218|NCT01737684|P3|Participant Flow|Participants With Mild Hepatic Insufficiencey|Participants with mild hepatic insufficiency were to receive a single oral dose of vibegron 100 mg.
72219|NCT01737684|P2|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72220|NCT01737684|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72221|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72222|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72223|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72224|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72225|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72226|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72227|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72228|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72229|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72230|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72231|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72232|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72233|NCT01737684|E2|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
72234|NCT01737684|E1|Reported Event|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
72235|NCT01737593|B4|Baseline|Total|Total of all reporting groups
72236|NCT01737593|B3|Baseline|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72237|NCT01737593|B2|Baseline|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72238|NCT01737593|B1|Baseline|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72239|NCT01737593|P3|Participant Flow|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72240|NCT01737593|P2|Participant Flow|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72241|NCT01737593|P1|Participant Flow|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72242|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72243|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72244|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72245|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72246|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72247|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72248|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72249|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72250|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72251|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72252|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72253|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72254|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72255|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72256|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72257|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72258|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72259|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72260|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72261|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72262|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72263|NCT01737593|O3|Outcome|Acetaminophen by Mouth (PO) - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72264|NCT01737593|O2|Outcome|Acetaminophen by Mouth (PO) - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72265|NCT01737593|O1|Outcome|Acetaminophen by Rectum (PR)|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72266|NCT01737593|E3|Reported Event|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72267|NCT01737593|E2|Reported Event|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
72268|NCT01737593|E1|Reported Event|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
72269|NCT01737021|B3|Baseline|Total|Total of all reporting groups
72270|NCT01737021|B2|Baseline|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
72271|NCT01737021|B1|Baseline|Psycho-educational Intervention|Received psycho-educational intervention.
72272|NCT01737021|P2|Participant Flow|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
72296|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72533|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72273|NCT01737021|P1|Participant Flow|Psycho-educational Intervention|"Psycho-education~Psycho-education: The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate."
72274|NCT01737021|O2|Outcome|Study Design|There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
72275|NCT01737021|O1|Outcome|Intervention|There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.
72276|NCT01737021|E2|Reported Event|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
72277|NCT01737021|E1|Reported Event|Psycho-educational Intervention|Received psycho-educational intervention.
72278|NCT01736930|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72279|NCT01736930|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72280|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72281|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72282|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72283|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72284|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72285|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72286|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72287|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72288|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72289|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72290|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72291|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72292|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72293|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72294|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72295|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72297|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72298|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72299|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72300|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72301|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72302|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72303|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72304|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72305|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72306|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72307|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72308|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72309|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72310|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72311|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72312|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72313|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72314|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72315|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72316|NCT01736930|E2|Reported Event|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
72317|NCT01736930|E1|Reported Event|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
72318|NCT01736917|B1|Baseline|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72319|NCT01736917|P1|Participant Flow|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72320|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72321|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72322|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72323|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72324|NCT01736917|E1|Reported Event|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
72325|NCT01736696|B8|Baseline|Total|Total of all reporting groups
72326|NCT01736696|B7|Baseline|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72327|NCT01736696|B6|Baseline|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72328|NCT01736696|B5|Baseline|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72329|NCT01736696|B4|Baseline|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72330|NCT01736696|B3|Baseline|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72331|NCT01736696|B2|Baseline|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72332|NCT01736696|B1|Baseline|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72333|NCT01736696|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72334|NCT01736696|P6|Participant Flow|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72335|NCT01736696|P5|Participant Flow|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72336|NCT01736696|P4|Participant Flow|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72337|NCT01736696|P3|Participant Flow|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72338|NCT01736696|P2|Participant Flow|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72339|NCT01736696|P1|Participant Flow|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72340|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72341|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72342|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72343|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72344|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72345|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72346|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72347|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72348|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72349|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72350|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72351|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72352|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72353|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72354|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72355|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72356|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72357|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72358|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72359|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72360|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72361|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72362|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72363|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72364|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72365|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72366|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72367|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72368|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72369|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72370|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72371|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72372|NCT01736696|O1|Outcome|All CP-690,550 Treated Participants|Included all participants who received either CP-690,550 OPC or CP-690,550 tablets for 14 days.
72373|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72374|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72375|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72376|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72377|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72378|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72379|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72380|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72381|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72382|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72383|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72785|NCT01736475|O1|Outcome|Prophylaxis|
72786|NCT01736475|O2|Outcome|On-demand|
72386|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72387|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72388|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72389|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72390|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72391|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72392|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72393|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72394|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72395|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72396|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72397|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72398|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72399|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72400|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72401|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72402|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72403|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72404|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72405|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72406|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72407|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72408|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72409|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72410|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72411|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72412|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72413|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72414|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72415|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72416|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72417|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72418|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72419|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72420|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72421|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72422|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72423|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72424|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72425|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72426|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72427|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72428|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72429|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72430|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72431|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72432|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72433|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72434|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72787|NCT01736475|O1|Outcome|Prophylaxis|
72435|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72436|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72437|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72438|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72439|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72440|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72441|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72442|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72443|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72444|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72445|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72446|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72447|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72448|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72449|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72450|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72451|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72452|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72453|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72454|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72455|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72456|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72457|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72458|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72459|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72460|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72461|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72462|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72463|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72464|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72465|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72466|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72467|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72468|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72469|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72470|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72471|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72472|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72473|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72474|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72475|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72476|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72477|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72478|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72479|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72480|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72481|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72482|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72483|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72788|NCT01736475|O2|Outcome|On-deamand|
72484|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72485|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72486|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72487|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72488|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72489|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72490|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72491|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72492|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72493|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72494|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72495|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72496|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72497|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72498|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72499|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72500|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72501|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72502|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72503|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72504|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72505|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72506|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72507|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72508|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72509|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72510|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72511|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72512|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72513|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72514|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72515|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72516|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72517|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72518|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72519|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72520|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72521|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72522|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72523|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72524|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72525|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72526|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72527|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72528|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72529|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72530|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72531|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72532|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72534|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72535|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72536|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72537|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72538|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72539|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72540|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72541|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72542|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72543|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72544|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72545|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72546|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72547|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72548|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72549|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72550|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72551|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72552|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72553|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72554|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72555|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72556|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72557|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72558|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72559|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72560|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72561|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72562|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72563|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72564|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72565|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72566|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72567|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72568|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72569|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72570|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72571|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72572|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72573|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72574|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72575|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72576|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72577|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72578|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72579|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72580|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72581|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72582|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72583|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72584|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72585|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72586|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72587|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72588|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72589|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72590|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72591|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72592|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72593|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72594|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72595|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72596|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72597|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72598|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72599|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72600|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72601|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72602|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72603|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72604|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72605|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72606|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72607|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72608|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72609|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72610|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72611|NCT01736696|O2|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72612|NCT01736696|O1|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72613|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72614|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72615|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72616|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72617|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72618|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72619|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72620|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72621|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72622|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72623|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72624|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72625|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72626|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72627|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72628|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72629|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72630|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72631|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72632|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72633|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72634|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72635|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72636|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72637|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72638|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72639|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72640|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72641|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72642|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72643|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72644|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72645|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72646|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72647|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72648|NCT01736696|E7|Reported Event|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
72649|NCT01736696|E6|Reported Event|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
72650|NCT01736696|E5|Reported Event|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
72651|NCT01736696|E4|Reported Event|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
72652|NCT01736696|E3|Reported Event|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
72653|NCT01736696|E2|Reported Event|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
72654|NCT01736696|E1|Reported Event|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
72655|NCT01736657|B1|Baseline|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72656|NCT01736657|P1|Participant Flow|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72657|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72658|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72659|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72660|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72661|NCT01736657|E1|Reported Event|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
72662|NCT01736579|B3|Baseline|Total|Total of all reporting groups
72663|NCT01736579|B2|Baseline|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72664|NCT01736579|B1|Baseline|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72665|NCT01736579|P2|Participant Flow|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72666|NCT01736579|P1|Participant Flow|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72667|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72668|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72669|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72670|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72671|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72672|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72673|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72674|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72675|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72789|NCT01736475|O1|Outcome|Prophylaxis|
72676|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72677|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72678|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72679|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72680|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72681|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72682|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72683|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72684|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72685|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72686|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72687|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72688|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72689|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72690|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72691|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72692|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72693|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72694|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72695|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
72696|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
72697|NCT01736579|E2|Reported Event|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
72698|NCT01736579|E1|Reported Event|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
72699|NCT01736540|B1|Baseline|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72700|NCT01736540|P1|Participant Flow|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72701|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72702|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72703|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72704|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72705|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72706|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72707|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72708|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72709|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72710|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72711|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72712|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72713|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72714|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72715|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72716|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72717|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72718|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72719|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72720|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72721|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72722|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72723|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72724|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72725|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72726|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72727|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72728|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72729|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72730|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72731|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72732|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72733|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72734|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72735|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72736|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72737|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72738|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72739|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72740|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72741|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72742|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72743|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72744|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72745|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72746|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72747|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
72748|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72749|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72750|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
72751|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
72752|NCT01736540|E4|Reported Event|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
72753|NCT01736540|E3|Reported Event|Other Anaemia|Subset of overall participants with other types of anaemias
72754|NCT01736540|E2|Reported Event|Myelodysplastic Syndrome (MDS)|Subset of overall participants with MDS
72755|NCT01736540|E1|Reported Event|Thalassaemia Major|Subset of overall participants with thalassemia major
72756|NCT01736527|B1|Baseline|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72757|NCT01736527|P1|Participant Flow|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72758|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72759|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72760|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72761|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72762|NCT01736527|E1|Reported Event|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
72763|NCT01736475|B3|Baseline|Total|Total of all reporting groups
72764|NCT01736475|B2|Baseline|On-demand|
72765|NCT01736475|B1|Baseline|Prophylaxis|
72766|NCT01736475|P2|Participant Flow|On-demand|10 to 60 ± 5 IU/kg
72767|NCT01736475|P1|Participant Flow|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
72768|NCT01736475|O2|Outcome|On-demand|
72769|NCT01736475|O1|Outcome|Prophylaxis|
72770|NCT01736475|O2|Outcome|On-demand|
72771|NCT01736475|O1|Outcome|Prophylaxis|
72772|NCT01736475|O2|Outcome|On-demand|
72773|NCT01736475|O1|Outcome|Prophylaxis|
72774|NCT01736475|O2|Outcome|On-demand|
72775|NCT01736475|O1|Outcome|Prophylaxis|
72776|NCT01736475|O2|Outcome|On-demand|
72777|NCT01736475|O1|Outcome|Prophylaxis|
72778|NCT01736475|O2|Outcome|On-demand|
72779|NCT01736475|O1|Outcome|Prophylaxis|
72780|NCT01736475|O2|Outcome|On-demand|
72781|NCT01736475|O1|Outcome|Prophylaxis|
72782|NCT01736475|O2|Outcome|On-demand|
72783|NCT01736475|O1|Outcome|Prophylaxis|
72784|NCT01736475|O2|Outcome|On-demand|
72803|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion SF-36 Scores
72804|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion HAEMO-SYM scores
72805|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion HAEMO-SYM scores
72806|NCT01736475|O2|Outcome|On-demand|10 to 60 ± 5 IU/kg
72807|NCT01736475|O1|Outcome|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
72808|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
72809|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
72810|NCT01736475|O1|Outcome|All Study Participants|
72811|NCT01736475|O2|Outcome|On-demand|
72812|NCT01736475|O1|Outcome|Prophylaxis|
72813|NCT01736475|O2|Outcome|On-demand|
72814|NCT01736475|O1|Outcome|Prophylaxis|Break-through bleeds during prophylaxis
72815|NCT01736475|O1|Outcome|Participants With a Bleeding Episode|All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens.
72816|NCT01736475|O2|Outcome|On-demand|
72817|NCT01736475|O1|Outcome|Prophylaxis|
72818|NCT01736475|E1|Reported Event|All Study Participants|All study participants were analyzed in a single arm/group.
72819|NCT01736215|B1|Baseline|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72820|NCT01736215|P1|Participant Flow|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72821|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72822|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72823|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72824|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72825|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72826|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72827|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72828|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72829|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72830|NCT01736215|E1|Reported Event|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
72831|NCT01736176|B1|Baseline|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72832|NCT01736176|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
72833|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72834|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72951|NCT01735201|B3|Baseline|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72835|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72836|NCT01736176|O2|Outcome|Week 60|
72837|NCT01736176|O1|Outcome|Week 12|
72838|NCT01736176|O2|Outcome|Week 60|
72839|NCT01736176|O1|Outcome|Week 12|
72840|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72841|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72842|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72843|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72844|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72845|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72846|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72847|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72848|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72849|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72850|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72851|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72852|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72853|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72854|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72944|NCT01735214|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72855|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72856|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72857|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72858|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72859|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72860|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72861|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72862|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72863|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72864|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72865|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72866|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72867|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72868|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72869|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72870|NCT01736176|O2|Outcome|Overall|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
72871|NCT01736176|O1|Outcome|Week 1-4|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
72872|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72945|NCT01735201|B9|Baseline|Total|Total of all reporting groups
74923|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
72873|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72874|NCT01736176|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
72875|NCT01735916|B4|Baseline|Total|Total of all reporting groups
72876|NCT01735916|B3|Baseline|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72877|NCT01735916|B2|Baseline|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72878|NCT01735916|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
72879|NCT01735916|P3|Participant Flow|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72880|NCT01735916|P2|Participant Flow|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72881|NCT01735916|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
72882|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72883|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72884|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72885|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72886|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72887|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72888|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72889|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72890|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72891|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72892|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72893|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72894|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72895|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72896|NCT01735916|E3|Reported Event|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
72897|NCT01735916|E2|Reported Event|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
72898|NCT01735916|E1|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
72899|NCT01735877|B3|Baseline|Total|Total of all reporting groups
72900|NCT01735877|B2|Baseline|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72901|NCT01735877|B1|Baseline|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72902|NCT01735877|P2|Participant Flow|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72903|NCT01735877|P1|Participant Flow|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72904|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72905|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72906|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72907|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72908|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72909|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72910|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72911|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72912|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72946|NCT01735201|B8|Baseline|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72947|NCT01735201|B7|Baseline|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72948|NCT01735201|B6|Baseline|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72949|NCT01735201|B5|Baseline|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72913|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72914|NCT01735877|E2|Reported Event|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
72915|NCT01735877|E1|Reported Event|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
72916|NCT01735630|B3|Baseline|Total|Total of all reporting groups
72917|NCT01735630|B2|Baseline|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72918|NCT01735630|B1|Baseline|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72919|NCT01735630|P2|Participant Flow|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72920|NCT01735630|P1|Participant Flow|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72921|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72922|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72923|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72924|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72925|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72926|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72927|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72928|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72929|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72930|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72931|NCT01735630|E2|Reported Event|Placebo|"Matched placebo BID for 12 weeks~Placebo"
72932|NCT01735630|E1|Reported Event|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
72933|NCT01735214|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72934|NCT01735214|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72935|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72936|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72937|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72938|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72939|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72940|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72941|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72942|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72943|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
72950|NCT01735201|B4|Baseline|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72952|NCT01735201|B2|Baseline|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72953|NCT01735201|B1|Baseline|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72954|NCT01735201|P8|Participant Flow|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72955|NCT01735201|P7|Participant Flow|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72956|NCT01735201|P6|Participant Flow|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72957|NCT01735201|P5|Participant Flow|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72958|NCT01735201|P4|Participant Flow|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72959|NCT01735201|P3|Participant Flow|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72960|NCT01735201|P2|Participant Flow|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72961|NCT01735201|P1|Participant Flow|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72962|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72963|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72964|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72965|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72966|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72967|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72968|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72969|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72970|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72971|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72972|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72973|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72974|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72975|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72976|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72977|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72978|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72979|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72980|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72981|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72982|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72983|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72984|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72985|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72986|NCT01735201|E8|Reported Event|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
72987|NCT01735201|E7|Reported Event|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
72988|NCT01735201|E6|Reported Event|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
72989|NCT01735201|E5|Reported Event|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
72990|NCT01735201|E4|Reported Event|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
72991|NCT01735201|E3|Reported Event|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
72992|NCT01735201|E2|Reported Event|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
72993|NCT01735201|E1|Reported Event|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
72994|NCT01734993|B1|Baseline|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
72995|NCT01734993|P1|Participant Flow|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [>] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
72996|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
72997|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
72998|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
72999|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73000|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73001|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73002|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73003|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73004|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73005|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73006|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73007|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73008|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73009|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73010|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73011|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73058|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73012|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73013|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73014|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73015|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73016|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73017|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73018|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73019|NCT01734993|E1|Reported Event|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
73020|NCT01734889|B1|Baseline|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73021|NCT01734889|P1|Participant Flow|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73022|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73023|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73024|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73025|NCT01734889|O1|Outcome|Age <5 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73026|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73027|NCT01734889|E1|Reported Event|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
73028|NCT01734785|B4|Baseline|Total|Total of all reporting groups
73029|NCT01734785|B3|Baseline|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73030|NCT01734785|B2|Baseline|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73031|NCT01734785|B1|Baseline|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73032|NCT01734785|P4|Participant Flow|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
73033|NCT01734785|P3|Participant Flow|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73059|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
73034|NCT01734785|P2|Participant Flow|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73035|NCT01734785|P1|Participant Flow|Empagliflozin 25 mg|Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73036|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73037|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73038|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73039|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73040|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73041|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73042|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73043|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73044|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73045|NCT01734785|E4|Reported Event|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
73046|NCT01734785|E3|Reported Event|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73047|NCT01734785|E2|Reported Event|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73048|NCT01734785|E1|Reported Event|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
73049|NCT01734772|B3|Baseline|Total|Total of all reporting groups
73050|NCT01734772|B2|Baseline|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
73051|NCT01734772|B1|Baseline|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
73052|NCT01734772|P2|Participant Flow|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
73053|NCT01734772|P1|Participant Flow|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
73054|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
73055|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73056|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
73057|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
73060|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73061|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
73062|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
73063|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73064|NCT01734772|E5|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
73065|NCT01734772|E4|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73066|NCT01734772|E3|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4.
73067|NCT01734772|E2|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
73068|NCT01734772|E1|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
73069|NCT01734655|B1|Baseline|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
73070|NCT01734655|P1|Participant Flow|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
73071|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
73072|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
73073|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
73074|NCT01734655|O1|Outcome|All Participants|all participants
73075|NCT01734655|O1|Outcome|All Participants|
73076|NCT01734655|O1|Outcome|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
73077|NCT01734655|E1|Reported Event|All Participants|Pregnant women who were overweight or obese and 18-40 yrs of age.
73078|NCT01734395|B1|Baseline|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73079|NCT01734395|P1|Participant Flow|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73080|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73081|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73082|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73083|NCT01734395|E1|Reported Event|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
73084|NCT01734317|B1|Baseline|Mepilex Transfer Ag|
73085|NCT01734317|P1|Participant Flow|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
73086|NCT01734317|O1|Outcome|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
73087|NCT01734317|E1|Reported Event|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
73088|NCT01734239|B3|Baseline|Total|Total of all reporting groups
73089|NCT01734239|B2|Baseline|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73090|NCT01734239|B1|Baseline|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73091|NCT01734239|P2|Participant Flow|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73092|NCT01734239|P1|Participant Flow|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73093|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73094|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73095|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73096|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73097|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73098|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73099|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73100|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73101|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73102|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
73103|NCT01734239|E1|Reported Event|Pneumovax™ 23|Participants received a single 0.5 mL intramuscular injection on Day 1
73104|NCT01733953|B3|Baseline|Total|Total of all reporting groups
73105|NCT01733953|B2|Baseline|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73106|NCT01733953|B1|Baseline|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73107|NCT01733953|P2|Participant Flow|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73108|NCT01733953|P1|Participant Flow|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73109|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73110|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73111|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73112|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73113|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73114|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73115|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73116|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73117|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73118|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73119|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73120|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73121|NCT01733953|E2|Reported Event|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
73122|NCT01733953|E1|Reported Event|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
73123|NCT01733758|B5|Baseline|Total|Total of all reporting groups
73124|NCT01733758|B4|Baseline|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73125|NCT01733758|B3|Baseline|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73126|NCT01733758|B2|Baseline|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73393|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73127|NCT01733758|B1|Baseline|Placebo|Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73128|NCT01733758|P4|Participant Flow|Open Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73129|NCT01733758|P3|Participant Flow|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73130|NCT01733758|P2|Participant Flow|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73131|NCT01733758|P1|Participant Flow|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
73132|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73133|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73134|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73135|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73136|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73137|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73138|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73139|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73140|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73141|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73142|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73143|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73144|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73145|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73146|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73147|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73148|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73149|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73150|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73151|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73152|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73153|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73154|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73155|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
74924|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
73156|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73157|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73158|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73159|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73160|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73161|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73162|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73163|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73164|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73165|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73166|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73167|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73168|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73169|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73170|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73171|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73172|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73173|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73174|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73175|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73176|NCT01733758|E5|Reported Event|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
73177|NCT01733758|E4|Reported Event|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
73178|NCT01733758|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73179|NCT01733758|E2|Reported Event|Placebo - After Switch|(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
73180|NCT01733758|E1|Reported Event|Placebo - Before Switch|(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
73181|NCT01733745|B3|Baseline|Total|Total of all reporting groups
73182|NCT01733745|B2|Baseline|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73183|NCT01733745|B1|Baseline|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73184|NCT01733745|P2|Participant Flow|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73185|NCT01733745|P1|Participant Flow|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73186|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73187|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73188|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73189|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73190|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73191|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73192|NCT01733745|E2|Reported Event|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
73193|NCT01733745|E1|Reported Event|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
73194|NCT01733732|B3|Baseline|Total|Total of all reporting groups
73195|NCT01733732|B2|Baseline|Systane Gel|One drop in each eye 4 times a day for 30 days
73196|NCT01733732|B1|Baseline|Systane Balance|One drop in each eye 4 times a day for 30 days
73197|NCT01733732|P2|Participant Flow|Systane Gel|One drop in each eye 4 times a day for 30 days
73198|NCT01733732|P1|Participant Flow|Systane Balance|One drop in each eye 4 times a day for 30 days
73199|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73200|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73201|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73202|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73203|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73204|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73205|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73206|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73207|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73208|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73209|NCT01733732|O4|Outcome|Systane Gel, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
73210|NCT01733732|O3|Outcome|Systane Gel, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
73211|NCT01733732|O2|Outcome|Systane Balance, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
73212|NCT01733732|O1|Outcome|Systane Balance, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
73213|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73214|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73215|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73216|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73217|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73218|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73219|NCT01733732|O6|Outcome|Systane Gel, Day 30|One drop in each eye 4 times a day for 30 days
73220|NCT01733732|O5|Outcome|Systane Gel, Day 14|One drop in each eye 4 times a day for 30 days
73221|NCT01733732|O4|Outcome|Systane Gel, Day 0|One drop in each eye 4 times a day for 30 days
73222|NCT01733732|O3|Outcome|Systane Balance, Day 30|One drop in each eye 4 times a day for 30 days
73223|NCT01733732|O2|Outcome|Systane Balance, Day 14|One drop in each eye 4 times a day for 30 days
73224|NCT01733732|O1|Outcome|Systane Balance, Day 0|One drop in each eye 4 times a day for 30 days
73225|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73226|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73227|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
73228|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
73229|NCT01733732|E2|Reported Event|Systane Gel|One drop in each eye 4 times a day for 30 days
73230|NCT01733732|E1|Reported Event|Systane Balance|One drop in each eye 4 times a day for 30 days
73231|NCT01733329|B3|Baseline|Total|Total of all reporting groups
73232|NCT01733329|B2|Baseline|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73233|NCT01733329|B1|Baseline|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73287|NCT01732835|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73234|NCT01733329|P2|Participant Flow|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73235|NCT01733329|P1|Participant Flow|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73236|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73237|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73238|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73239|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73240|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73241|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73242|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73243|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73244|NCT01733329|E2|Reported Event|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
73245|NCT01733329|E1|Reported Event|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
73246|NCT01733277|B3|Baseline|Total|Total of all reporting groups
73247|NCT01733277|B2|Baseline|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73248|NCT01733277|B1|Baseline|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73249|NCT01733277|P2|Participant Flow|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73250|NCT01733277|P1|Participant Flow|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73251|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73252|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73253|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73254|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73255|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73256|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73257|NCT01733277|E2|Reported Event|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
73258|NCT01733277|E1|Reported Event|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
73259|NCT01733069|B3|Baseline|Total|Total of all reporting groups
73260|NCT01733069|B2|Baseline|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
73428|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
73261|NCT01733069|B1|Baseline|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
73262|NCT01733069|P2|Participant Flow|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
73263|NCT01733069|P1|Participant Flow|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses.
73264|NCT01733069|O2|Outcome|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
73265|NCT01733069|O1|Outcome|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
73266|NCT01733069|E2|Reported Event|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
73267|NCT01733069|E1|Reported Event|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
73268|NCT01733056|B4|Baseline|Total|Total of all reporting groups
73269|NCT01733056|B3|Baseline|TNF Alpha Blocker|Patients with skin diseases taking TNF alpha blockers
73270|NCT01733056|B2|Baseline|Azathioprine|Patients with skin diseases taking azathioprine
73271|NCT01733056|B1|Baseline|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
73272|NCT01733056|P3|Participant Flow|TNF Alpha Blockers|
73273|NCT01733056|P2|Participant Flow|Azathioprine|
73274|NCT01733056|P1|Participant Flow|Healthy Volunteer|
73275|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
73276|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
73277|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
73278|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
73279|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
73280|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
73281|NCT01733056|E6|Reported Event|TNF Alpha Blocker Post-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
73282|NCT01733056|E5|Reported Event|TNF Alpha Blocker Pre-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine
73283|NCT01733056|E4|Reported Event|Azathioprine Post-vaccination|Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine
73284|NCT01733056|E3|Reported Event|Azathioprine Pre-vaccination|Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine
73285|NCT01733056|E2|Reported Event|Healthy Volunteer Post-vaccination|Healthy volunteers who had blood drawn after vaccination with influenza vaccine
73286|NCT01733056|E1|Reported Event|Healthy Volunteer Pre-vaccination|Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine
73391|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73288|NCT01732835|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73289|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73290|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73291|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73292|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73293|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73294|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73295|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73296|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73297|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73298|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73299|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73300|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73301|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73302|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73303|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73304|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73305|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73306|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73307|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73308|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73309|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73310|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73311|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73312|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73313|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73314|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73315|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73316|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73317|NCT01732835|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
73318|NCT01732796|B4|Baseline|Total|Total of all reporting groups
73319|NCT01732796|B3|Baseline|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73320|NCT01732796|B2|Baseline|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73321|NCT01732796|B1|Baseline|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
73322|NCT01732796|P3|Participant Flow|24 wk CR FDV+DBV+RBV|600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73323|NCT01732796|P2|Participant Flow|24 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
73324|NCT01732796|P1|Participant Flow|16 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
73325|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73326|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73327|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73328|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73329|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73330|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73331|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73332|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73333|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73334|NCT01732796|O2|Outcome|16 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
73335|NCT01732796|O1|Outcome|24 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
73336|NCT01732796|E3|Reported Event|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
73337|NCT01732796|E2|Reported Event|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
73338|NCT01732796|E1|Reported Event|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
73339|NCT01732770|B3|Baseline|Total|Total of all reporting groups
73340|NCT01732770|B2|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73341|NCT01732770|B1|Baseline|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73342|NCT01732770|P2|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73343|NCT01732770|P1|Participant Flow|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73344|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73345|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73346|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73347|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73348|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73349|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73350|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73351|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73352|NCT01732770|E2|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
73353|NCT01732770|E1|Reported Event|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
73354|NCT01732757|B4|Baseline|Total|Total of all reporting groups
73355|NCT01732757|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73356|NCT01732757|B2|Baseline|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73357|NCT01732757|B1|Baseline|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73358|NCT01732757|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73359|NCT01732757|P2|Participant Flow|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73360|NCT01732757|P1|Participant Flow|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73361|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73362|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73363|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73364|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73365|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73366|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73367|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73368|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73369|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73370|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73371|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73372|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73373|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73374|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73375|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73376|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73377|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73378|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73379|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73380|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73381|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73382|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73383|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73384|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73385|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73386|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73387|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73388|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73389|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73390|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73392|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73394|NCT01732757|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
73395|NCT01732757|E2|Reported Event|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
73396|NCT01732757|E1|Reported Event|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
73397|NCT01732692|B3|Baseline|Total|Total of all reporting groups
73398|NCT01732692|B2|Baseline|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73399|NCT01732692|B1|Baseline|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73400|NCT01732692|P2|Participant Flow|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73401|NCT01732692|P1|Participant Flow|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73402|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73403|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73404|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73405|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73406|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73407|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73408|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73409|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73410|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73411|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73412|NCT01732692|E2|Reported Event|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
73413|NCT01732692|E1|Reported Event|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
73414|NCT01732588|B4|Baseline|Total|Total of all reporting groups
73415|NCT01732588|B3|Baseline|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
73416|NCT01732588|B2|Baseline|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A)
73417|NCT01732588|B1|Baseline|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
73418|NCT01732588|P3|Participant Flow|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
73419|NCT01732588|P2|Participant Flow|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A).
73420|NCT01732588|P1|Participant Flow|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
73421|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
73422|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
73423|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
73424|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
73425|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
73426|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
73427|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
74925|NCT01725984|E2|Reported Event|AdVance XP|Subjects implanted with the AdVance XP Male Sling
73429|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
73430|NCT01732588|E3|Reported Event|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
73431|NCT01732588|E2|Reported Event|Regimen B - 120 mg OZ439 IR Caplet|Single oral dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
73432|NCT01732588|E1|Reported Event|Regimen A - 120mg OZ439 PIB|Single oral dose of 120 mg OZ439 as powder in bottle (PIB) formulation.
73433|NCT01732549|B3|Baseline|Total|Total of all reporting groups
73434|NCT01732549|B2|Baseline|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
73435|NCT01732549|B1|Baseline|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
73436|NCT01732549|P2|Participant Flow|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
73437|NCT01732549|P1|Participant Flow|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
73438|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73439|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73440|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73441|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73442|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73443|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73444|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73445|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73446|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73447|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73448|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73449|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
73450|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73451|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
73452|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
73453|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
73454|NCT01732549|E2|Reported Event|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
73455|NCT01732549|E1|Reported Event|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
73456|NCT01732510|B8|Baseline|Total|Total of all reporting groups
73457|NCT01732510|B7|Baseline|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73458|NCT01732510|B6|Baseline|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73459|NCT01732510|B5|Baseline|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73460|NCT01732510|B4|Baseline|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73461|NCT01732510|B3|Baseline|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73462|NCT01732510|B2|Baseline|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73463|NCT01732510|B1|Baseline|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73464|NCT01732510|P7|Participant Flow|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73465|NCT01732510|P6|Participant Flow|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73466|NCT01732510|P5|Participant Flow|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73467|NCT01732510|P4|Participant Flow|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73468|NCT01732510|P3|Participant Flow|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73469|NCT01732510|P2|Participant Flow|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73470|NCT01732510|P1|Participant Flow|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73471|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73472|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73473|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
73474|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73475|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73476|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73477|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73478|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73479|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73480|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73481|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73482|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73483|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73484|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73485|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73486|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73487|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73488|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73489|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73490|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73491|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73492|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73493|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73494|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73495|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73496|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73497|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73498|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73499|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73500|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73501|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73502|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73503|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73504|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73505|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73506|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73507|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73508|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73509|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73510|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73511|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73512|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73513|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73514|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73515|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73516|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73517|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73518|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73519|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73520|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73521|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73522|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73523|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73524|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73525|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73526|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73527|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73528|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73529|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73530|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73531|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73532|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73533|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73534|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73535|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73536|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73537|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73538|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73539|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73540|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
73541|NCT01732510|E7|Reported Event|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
73542|NCT01732510|E6|Reported Event|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73543|NCT01732510|E5|Reported Event|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
73544|NCT01732510|E4|Reported Event|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73545|NCT01732510|E3|Reported Event|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73546|NCT01732510|E2|Reported Event|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73547|NCT01732510|E1|Reported Event|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
73548|NCT01732484|B1|Baseline|Cataract Surgery|eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
73549|NCT01732484|P1|Participant Flow|Patients Included|
73550|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
73551|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
73552|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
73553|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
73554|NCT01732484|E2|Reported Event|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
73555|NCT01732484|E1|Reported Event|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
73556|NCT01732471|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73557|NCT01732471|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73558|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
74903|NCT01725984|P2|Participant Flow|AdVance XP|Subjects previously implanted with the AdVance XP male sling
73559|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73560|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73561|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73562|NCT01732471|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
73563|NCT01732263|B3|Baseline|Total|Total of all reporting groups
73564|NCT01732263|B2|Baseline|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73565|NCT01732263|B1|Baseline|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73566|NCT01732263|P2|Participant Flow|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73567|NCT01732263|P1|Participant Flow|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73568|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73569|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73570|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73571|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73572|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73573|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73574|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73575|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73576|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73577|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73592|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
74254|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
73578|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73579|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73580|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73581|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73582|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73583|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73584|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73585|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73586|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73587|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73588|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73589|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73590|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73591|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73593|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73594|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73595|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73596|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73597|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73598|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73599|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
73600|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73601|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73602|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73603|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
73604|NCT01732263|E2|Reported Event|Matched Healthy Subjects|
73605|NCT01732263|E1|Reported Event|Hepatic Impairment|
73606|NCT01731470|B1|Baseline|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
73607|NCT01731470|P1|Participant Flow|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
73608|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
73609|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
73610|NCT01731470|E1|Reported Event|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
73611|NCT01731041|B3|Baseline|Total|Total of all reporting groups
73612|NCT01731041|B2|Baseline|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
74904|NCT01725984|P1|Participant Flow|AdVance|Subjects previously implanted with the AdVance Male Sling
73613|NCT01731041|B1|Baseline|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73614|NCT01731041|P2|Participant Flow|Ticagrelor 90mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
73615|NCT01731041|P1|Participant Flow|Ticagrelor 180mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
73616|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73617|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73618|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73619|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73620|NCT01731041|E2|Reported Event|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73621|NCT01731041|E1|Reported Event|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
73622|NCT01730378|B3|Baseline|Total|Total of all reporting groups
73623|NCT01730378|B2|Baseline|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73624|NCT01730378|B1|Baseline|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73625|NCT01730378|P2|Participant Flow|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73626|NCT01730378|P1|Participant Flow|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73627|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73628|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73629|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73630|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73631|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73632|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73633|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73634|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73635|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73636|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73637|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73638|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73639|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73640|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73641|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73642|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73643|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73644|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73645|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73646|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73647|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73648|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73649|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73650|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73651|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73652|NCT01730378|E2|Reported Event|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
73653|NCT01730378|E1|Reported Event|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
73654|NCT01730339|B3|Baseline|Total|Total of all reporting groups
73655|NCT01730339|B2|Baseline|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73656|NCT01730339|B1|Baseline|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73657|NCT01730339|P2|Participant Flow|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73658|NCT01730339|P1|Participant Flow|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73659|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73660|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
74255|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
73661|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73662|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73663|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73664|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73665|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73666|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73667|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73668|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73669|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
73670|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
73671|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
73672|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
73673|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
73674|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
73675|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
73676|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
73677|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
73678|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
73679|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
73680|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
73681|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
73682|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
73683|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast
73684|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
73685|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
74905|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
73686|NCT01730339|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
73687|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
73688|NCT01730339|O1|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
73689|NCT01730339|E2|Reported Event|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
73690|NCT01730339|E1|Reported Event|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
73691|NCT01730053|B7|Baseline|Total|Total of all reporting groups
73692|NCT01730053|B6|Baseline|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73693|NCT01730053|B5|Baseline|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73694|NCT01730053|B4|Baseline|Rosuvastatin 40 mg|.Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73695|NCT01730053|B3|Baseline|Alirocumab 75/up to 150 + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73696|NCT01730053|B2|Baseline|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73697|NCT01730053|B1|Baseline|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73698|NCT01730053|P6|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73699|NCT01730053|P5|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73700|NCT01730053|P4|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73701|NCT01730053|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73702|NCT01730053|P2|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73703|NCT01730053|P1|Participant Flow|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73704|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74906|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
73705|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73706|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73707|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73708|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73709|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73710|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73711|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73712|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73713|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73714|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73715|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73716|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73717|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73718|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73719|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73720|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73721|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73757|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
74907|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
73722|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73723|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73724|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73725|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73726|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73727|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73728|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73729|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73730|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73731|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73732|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73733|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73734|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73735|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73736|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73737|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73738|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
73739|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73740|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73741|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73742|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73743|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73744|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73745|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73746|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73747|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73748|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73749|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73750|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73751|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73752|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73753|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73754|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73755|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73756|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74070|NCT01729728|O3|Outcome|TL Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73758|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73759|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
73760|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73761|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73762|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73763|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73764|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73765|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73766|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73767|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73768|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73769|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73770|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73771|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73772|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73773|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73774|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73775|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73776|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73777|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73778|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73779|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73780|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73781|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73782|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73783|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73784|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73785|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73786|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73787|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73788|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73789|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73790|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73791|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73792|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74256|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
73793|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73794|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73795|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73796|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73797|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73798|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73799|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73800|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73801|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73802|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73803|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73804|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73805|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73806|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73807|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73808|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73809|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74071|NCT01729728|O2|Outcome|TL Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73810|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73811|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73812|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73813|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73814|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73815|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73816|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73817|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73818|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73819|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73820|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73821|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73822|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73823|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73824|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73825|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73826|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73844|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
74908|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
73827|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73828|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73829|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73830|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73831|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73832|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73833|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73834|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73835|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73836|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73837|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
73838|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
73839|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73840|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73841|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73842|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73843|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
74072|NCT01729728|O1|Outcome|TL Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73845|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73846|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73847|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
73848|NCT01730053|E6|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73849|NCT01730053|E5|Reported Event|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
73850|NCT01730053|E4|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
73851|NCT01730053|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73852|NCT01730053|E2|Reported Event|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
73853|NCT01730053|E1|Reported Event|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
73854|NCT01730040|B8|Baseline|Total|Total of all reporting groups
73855|NCT01730040|B7|Baseline|Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73856|NCT01730040|B6|Baseline|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73857|NCT01730040|B5|Baseline|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73858|NCT01730040|B4|Baseline|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73859|NCT01730040|B3|Baseline|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73860|NCT01730040|B2|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73861|NCT01730040|B1|Baseline|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73862|NCT01730040|P7|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73863|NCT01730040|P6|Participant Flow|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74073|NCT01729728|O3|Outcome|ALP Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73864|NCT01730040|P5|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73865|NCT01730040|P4|Participant Flow|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73866|NCT01730040|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73867|NCT01730040|P2|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73868|NCT01730040|P1|Participant Flow|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73869|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73870|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73871|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73872|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73873|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73874|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73875|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73876|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73877|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73878|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73879|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73880|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74074|NCT01729728|O2|Outcome|ALP Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73881|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73882|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73883|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73884|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73885|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73886|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73887|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73888|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73889|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73890|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73891|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73892|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73893|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73894|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73895|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73896|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73897|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74075|NCT01729728|O1|Outcome|ALP Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73898|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73899|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73900|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73901|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73902|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73903|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73904|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73905|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73906|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73907|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73908|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73909|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73910|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73911|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73912|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73913|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73914|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73949|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74250|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
73915|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73916|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73917|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73918|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73919|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73920|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73921|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73922|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73923|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73924|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73925|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73926|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73927|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73928|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73929|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73930|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73931|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74062|NCT01729871|E1|Reported Event|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
73932|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73933|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73934|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73935|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73936|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73937|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73938|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73939|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73940|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73941|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73942|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73943|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73944|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73945|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73946|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73947|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73948|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74063|NCT01729728|B4|Baseline|Total|Total of all reporting groups
74064|NCT01729728|B3|Baseline|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73950|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73951|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73952|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73953|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73954|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73955|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73956|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73957|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73958|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73959|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73960|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73961|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73962|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73963|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73964|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73965|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73966|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74065|NCT01729728|B2|Baseline|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
73967|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73968|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73969|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73970|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73971|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73972|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73973|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73974|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73975|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73976|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73977|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73978|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73979|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73980|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73981|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73982|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73983|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74066|NCT01729728|B1|Baseline|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74909|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
73984|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73985|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73986|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73987|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73988|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73989|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73990|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73991|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73992|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73993|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73994|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
73995|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
73996|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
73997|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73998|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
73999|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74000|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74067|NCT01729728|P3|Participant Flow|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)
74001|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74002|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74003|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74004|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74005|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74006|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74007|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74008|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74009|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74010|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74011|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74012|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74013|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74014|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74015|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74016|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74017|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74068|NCT01729728|P2|Participant Flow|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
74018|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74019|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74020|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74021|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74022|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74023|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74024|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74025|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74026|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74027|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74028|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74029|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74030|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74031|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74032|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74033|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74034|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74069|NCT01729728|P1|Participant Flow|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)
74910|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
74035|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74036|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74037|NCT01730040|E7|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74038|NCT01730040|E6|Reported Event|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
74039|NCT01730040|E5|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74040|NCT01730040|E4|Reported Event|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
74041|NCT01730040|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
74042|NCT01730040|E2|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
74043|NCT01730040|E1|Reported Event|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
74044|NCT01729871|B3|Baseline|Total|Total of all reporting groups
74045|NCT01729871|B2|Baseline|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74046|NCT01729871|B1|Baseline|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74047|NCT01729871|P2|Participant Flow|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74048|NCT01729871|P1|Participant Flow|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74049|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74050|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74051|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74052|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74053|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74054|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74055|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74056|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74057|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74058|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74059|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74060|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
74061|NCT01729871|E2|Reported Event|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
74076|NCT01729728|O3|Outcome|CK Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74077|NCT01729728|O2|Outcome|CK Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74078|NCT01729728|O1|Outcome|CK Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74079|NCT01729728|O3|Outcome|Protein Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74080|NCT01729728|O2|Outcome|Protein Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74081|NCT01729728|O1|Outcome|Protein Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74082|NCT01729728|O3|Outcome|LDH Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74083|NCT01729728|O2|Outcome|LDH Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74084|NCT01729728|O1|Outcome|LDH Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74085|NCT01729728|O3|Outcome|Bilirubin Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74086|NCT01729728|O2|Outcome|Bilirubin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74087|NCT01729728|O1|Outcome|Bilirubin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74088|NCT01729728|O3|Outcome|GGT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74089|NCT01729728|O2|Outcome|GGT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74090|NCT01729728|O1|Outcome|GGT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74091|NCT01729728|O3|Outcome|ALT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74092|NCT01729728|O2|Outcome|ALT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74093|NCT01729728|O1|Outcome|ALT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74094|NCT01729728|O3|Outcome|Urine pH: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74095|NCT01729728|O2|Outcome|Urine pH: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74096|NCT01729728|O1|Outcome|Urine pH: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74097|NCT01729728|O3|Outcome|Specific Gravity Urine: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74098|NCT01729728|O2|Outcome|Specific Gravity Urine: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74099|NCT01729728|O1|Outcome|Specific Gravity Urine: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74100|NCT01729728|O3|Outcome|Glomerular Filtration Rate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74101|NCT01729728|O2|Outcome|Glomerular Filtration Rate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74102|NCT01729728|O1|Outcome|Glomerular Filtration Rate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74103|NCT01729728|O3|Outcome|Urate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74104|NCT01729728|O2|Outcome|Urate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74105|NCT01729728|O1|Outcome|Urate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74106|NCT01729728|O3|Outcome|Albumin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74107|NCT01729728|O2|Outcome|Albumin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74108|NCT01729728|O1|Outcome|Albumin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74251|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74109|NCT01729728|O3|Outcome|Triglycerides Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74110|NCT01729728|O2|Outcome|Triglycerides Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74111|NCT01729728|O1|Outcome|Triglycerides Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74112|NCT01729728|O3|Outcome|AST Activity: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74113|NCT01729728|O2|Outcome|AST Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74114|NCT01729728|O1|Outcome|AST Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74115|NCT01729728|O3|Outcome|Creatinine Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74116|NCT01729728|O2|Outcome|Creatinine Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74117|NCT01729728|O1|Outcome|Creatinine Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74118|NCT01729728|O3|Outcome|BUN Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74119|NCT01729728|O2|Outcome|BUN Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74120|NCT01729728|O1|Outcome|BUN Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74121|NCT01729728|O3|Outcome|Blood Phosphate Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74122|NCT01729728|O2|Outcome|Blood Phosphate Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74123|NCT01729728|O1|Outcome|Blood Phosphate Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74124|NCT01729728|O3|Outcome|Blood Chloride Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74125|NCT01729728|O2|Outcome|Blood Chloride Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74126|NCT01729728|O1|Outcome|Blood Chloride Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74127|NCT01729728|O3|Outcome|Blood Calcium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74128|NCT01729728|O2|Outcome|Blood Calcium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74129|NCT01729728|O1|Outcome|Blood Calcium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74130|NCT01729728|O3|Outcome|Blood Potassium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74131|NCT01729728|O2|Outcome|Blood Potassium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74132|NCT01729728|O1|Outcome|Blood Potassium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74133|NCT01729728|O3|Outcome|Blood Sodium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74134|NCT01729728|O2|Outcome|Blood Sodium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74135|NCT01729728|O1|Outcome|Blood Sodium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74136|NCT01729728|O3|Outcome|Blood Glucose Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74137|NCT01729728|O2|Outcome|Blood Glucose Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74138|NCT01729728|O1|Outcome|Blood Glucose Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74139|NCT01729728|O3|Outcome|Leukocyte Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74140|NCT01729728|O2|Outcome|Leukocyte Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74703|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74141|NCT01729728|O1|Outcome|Leukocyte Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74142|NCT01729728|O3|Outcome|Platelet Count: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74143|NCT01729728|O2|Outcome|Platelet Count: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74144|NCT01729728|O1|Outcome|Platelet Count: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74145|NCT01729728|O3|Outcome|Mean Corpuscular Volume: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74146|NCT01729728|O2|Outcome|Mean Corpuscular Volume: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74147|NCT01729728|O1|Outcome|Mean Corpuscular Volume: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74148|NCT01729728|O3|Outcome|Hematocrit: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74149|NCT01729728|O2|Outcome|Hematocrit: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74150|NCT01729728|O1|Outcome|Hematocrit: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74151|NCT01729728|O3|Outcome|Hemoglobin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74152|NCT01729728|O2|Outcome|Hemoglobin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74153|NCT01729728|O1|Outcome|Hemoglobin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74154|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74155|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74156|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74157|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Tmax|Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.
74158|NCT01729728|O3|Outcome|Young and Very Young Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74159|NCT01729728|O2|Outcome|Older Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74160|NCT01729728|O1|Outcome|Adolescents With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74161|NCT01729728|O3|Outcome|Number of TEAEs: Young and Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.
74162|NCT01729728|O2|Outcome|Number of TEAEs: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
74163|NCT01729728|O1|Outcome|Number of TEAEs: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
74164|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74165|NCT01729728|O3|Outcome|ECG Heart Rate Change: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74166|NCT01729728|O2|Outcome|ECG Heart Rate Change: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74167|NCT01729728|O1|Outcome|ECG Heart Rate Change: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74168|NCT01729728|O3|Outcome|ECG Changes: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74169|NCT01729728|O2|Outcome|ECG Changes: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74170|NCT01729728|O1|Outcome|ECG Changes: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74171|NCT01729728|O3|Outcome|Blood Pressure: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74172|NCT01729728|O2|Outcome|Blood Pressure: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74173|NCT01729728|O1|Outcome|Blood Pressure: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74174|NCT01729728|O3|Outcome|Oxygen Saturation: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74175|NCT01729728|O2|Outcome|Oxygen Saturation: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74176|NCT01729728|O1|Outcome|Oxygen Saturation: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74177|NCT01729728|O3|Outcome|Respiratory Rates: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74178|NCT01729728|O2|Outcome|Respiratory Rates: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74179|NCT01729728|O1|Outcome|Respiratory Rates: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74180|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74181|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
74182|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
74183|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
74184|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
74185|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
74186|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
74187|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
74188|NCT01729728|O1|Outcome|Sum of Pain Intensity Differences|"The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.~The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences."
74189|NCT01729728|O1|Outcome|Face, Legs, Activity, Cry, Consolability Scale|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74190|NCT01729728|O2|Outcome|Faces Pain Scale: Young Children|Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.
74191|NCT01729728|O1|Outcome|Faces Pain Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
74192|NCT01729728|O2|Outcome|McGrath Color Analog Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74193|NCT01729728|O1|Outcome|McGrath Color Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74194|NCT01729728|O1|Outcome|Visual Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74195|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
74196|NCT01729728|E3|Reported Event|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74197|NCT01729728|E2|Reported Event|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74198|NCT01729728|E1|Reported Event|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
74199|NCT01729559|B3|Baseline|Total|Total of all reporting groups
74200|NCT01729559|B2|Baseline|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74201|NCT01729559|B1|Baseline|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74202|NCT01729559|P2|Participant Flow|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74203|NCT01729559|P1|Participant Flow|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74911|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
74204|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74205|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74206|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74207|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74208|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74209|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74210|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74211|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74212|NCT01729559|E2|Reported Event|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
74213|NCT01729559|E1|Reported Event|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
74214|NCT01729247|B1|Baseline|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
74215|NCT01729247|P1|Participant Flow|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
74216|NCT01729247|O1|Outcome|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
74217|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
74218|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
74219|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
74220|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
74221|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
74222|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
74223|NCT01729247|O2|Outcome|No ICS Use|Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
74224|NCT01729247|O1|Outcome|ICS Use|Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
74225|NCT01729247|O2|Outcome|High ACT Score|Participants who had an asthma control test (ACT) score of >19, which indicates well-controlled asthma
74226|NCT01729247|O1|Outcome|Low ACT Score|Participants who had an asthma control test (ACT) score of <=19, which indicates less well-controlled asthma
74227|NCT01729247|E1|Reported Event|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
74228|NCT01729026|B3|Baseline|Total|Total of all reporting groups
74229|NCT01729026|B2|Baseline|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74252|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74253|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74912|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
74230|NCT01729026|B1|Baseline|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74231|NCT01729026|P2|Participant Flow|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74232|NCT01729026|P1|Participant Flow|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74233|NCT01729026|O2|Outcome|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74234|NCT01729026|O1|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74235|NCT01729026|E2|Reported Event|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74236|NCT01729026|E1|Reported Event|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
74237|NCT01728792|B6|Baseline|Total|Total of all reporting groups
74238|NCT01728792|B5|Baseline|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74239|NCT01728792|B4|Baseline|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74240|NCT01728792|B3|Baseline|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74241|NCT01728792|B2|Baseline|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74242|NCT01728792|B1|Baseline|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74243|NCT01728792|P5|Participant Flow|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74244|NCT01728792|P4|Participant Flow|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74245|NCT01728792|P3|Participant Flow|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74246|NCT01728792|P2|Participant Flow|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74247|NCT01728792|P1|Participant Flow|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74248|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74249|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74257|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74258|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74259|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74260|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74261|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74262|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74263|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74264|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74265|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74266|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74267|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74268|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74269|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74270|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74271|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74272|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74273|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74274|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74275|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74276|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74277|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74278|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74279|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74280|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74281|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74282|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74283|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74284|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74285|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74286|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74287|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74288|NCT01728792|E5|Reported Event|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74289|NCT01728792|E4|Reported Event|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
74290|NCT01728792|E3|Reported Event|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
74291|NCT01728792|E2|Reported Event|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
74292|NCT01728792|E1|Reported Event|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
74293|NCT01728584|B5|Baseline|Total|Total of all reporting groups
74294|NCT01728584|B4|Baseline|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74295|NCT01728584|B3|Baseline|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74296|NCT01728584|B2|Baseline|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74449|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74297|NCT01728584|B1|Baseline|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74298|NCT01728584|P4|Participant Flow|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74299|NCT01728584|P3|Participant Flow|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
74300|NCT01728584|P2|Participant Flow|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74301|NCT01728584|P1|Participant Flow|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74302|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74303|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74304|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74305|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74306|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74307|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74308|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74309|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74310|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74311|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74312|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74313|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74314|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74315|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74316|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74317|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74318|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74319|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74320|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74321|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74322|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74323|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74324|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74350|NCT01728584|E2|Reported Event|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74325|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74326|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74327|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74328|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74329|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74330|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74331|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74332|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74333|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74334|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74335|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74336|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
74337|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
74338|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74339|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74340|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74341|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74342|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
74343|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74344|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
74345|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
74346|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
74347|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
74348|NCT01728584|E4|Reported Event|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
74349|NCT01728584|E3|Reported Event|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
74351|NCT01728584|E1|Reported Event|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
74352|NCT01728376|B7|Baseline|Total|Total of all reporting groups
74353|NCT01728376|B6|Baseline|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74354|NCT01728376|B5|Baseline|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74355|NCT01728376|B4|Baseline|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74356|NCT01728376|B3|Baseline|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74357|NCT01728376|B2|Baseline|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74358|NCT01728376|B1|Baseline|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74359|NCT01728376|P6|Participant Flow|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74360|NCT01728376|P5|Participant Flow|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74361|NCT01728376|P4|Participant Flow|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74362|NCT01728376|P3|Participant Flow|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74363|NCT01728376|P2|Participant Flow|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74364|NCT01728376|P1|Participant Flow|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74365|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74366|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74367|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74368|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74913|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
74369|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74370|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74371|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74372|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74373|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74374|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74375|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74376|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74377|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74378|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74379|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74380|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74381|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74382|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74383|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74384|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74385|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74386|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74387|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74388|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74389|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74390|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74391|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74392|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74393|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74394|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74395|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74396|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74397|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74398|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74399|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74400|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74401|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74402|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74914|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
74403|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74404|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74405|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74406|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74407|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74408|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74409|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74410|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74411|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74412|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74413|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74414|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74415|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74416|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74417|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74418|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74419|NCT01728376|E6|Reported Event|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74420|NCT01728376|E5|Reported Event|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74421|NCT01728376|E4|Reported Event|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74422|NCT01728376|E3|Reported Event|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74423|NCT01728376|E2|Reported Event|Comparator - 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
74424|NCT01728376|E1|Reported Event|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
74425|NCT01728337|B1|Baseline|Xeomin and Dysport|Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
74426|NCT01728337|P1|Participant Flow|Dysport and Xeomin|Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
74427|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
74428|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
74429|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
74430|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
74431|NCT01728337|E2|Reported Event|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
74432|NCT01728337|E1|Reported Event|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
74433|NCT01728324|B4|Baseline|Total|Total of all reporting groups
74434|NCT01728324|B3|Baseline|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74435|NCT01728324|B2|Baseline|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74436|NCT01728324|B1|Baseline|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74437|NCT01728324|P3|Participant Flow|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74438|NCT01728324|P2|Participant Flow|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74439|NCT01728324|P1|Participant Flow|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74440|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74441|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74442|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74443|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74444|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74445|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74446|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74447|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74448|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74450|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74451|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74452|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
74453|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
74454|NCT01728324|E3|Reported Event|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
74455|NCT01728324|E2|Reported Event|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
74456|NCT01728324|E1|Reported Event|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
74457|NCT01728246|B3|Baseline|Total|Total of all reporting groups
74458|NCT01728246|B2|Baseline|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74459|NCT01728246|B1|Baseline|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74460|NCT01728246|P2|Participant Flow|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74461|NCT01728246|P1|Participant Flow|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74462|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74463|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74464|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74465|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74466|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74467|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74468|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74469|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74470|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74471|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74472|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74473|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74474|NCT01728246|E2|Reported Event|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
74475|NCT01728246|E1|Reported Event|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
74476|NCT01728116|B3|Baseline|Total|Total of all reporting groups
74477|NCT01728116|B2|Baseline|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74478|NCT01728116|B1|Baseline|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
74479|NCT01728116|P2|Participant Flow|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
74480|NCT01728116|P1|Participant Flow|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
74513|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74481|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74482|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74483|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74484|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74485|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74486|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74487|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74488|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74489|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74490|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74491|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74492|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74493|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74494|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74495|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74496|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
74497|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
74498|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74499|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
74500|NCT01728116|E2|Reported Event|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
74501|NCT01728116|E1|Reported Event|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
74502|NCT01727895|B3|Baseline|Total|Total of all reporting groups
74503|NCT01727895|B2|Baseline|Control Group|No intervention
74504|NCT01727895|B1|Baseline|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
74505|NCT01727895|P2|Participant Flow|Control Group|No intervention
74506|NCT01727895|P1|Participant Flow|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
74507|NCT01727895|O2|Outcome|Control Group|No intervention
74508|NCT01727895|O1|Outcome|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
74509|NCT01727895|E2|Reported Event|Control Group|No intervention
74510|NCT01727895|E1|Reported Event|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
74511|NCT01727791|B1|Baseline|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74512|NCT01727791|P1|Participant Flow|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74699|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74514|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74515|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74516|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74517|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74518|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74519|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74520|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74521|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74522|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74523|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74524|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74525|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74526|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74527|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74528|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74529|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74530|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74531|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74532|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74533|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74534|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74535|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74536|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74537|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74538|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74539|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74540|NCT01727791|E1|Reported Event|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
74541|NCT01727713|B1|Baseline|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74542|NCT01727713|P1|Participant Flow|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74543|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74544|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74545|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74546|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74547|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74700|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74548|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74549|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74550|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74551|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74552|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74553|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74554|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74555|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74556|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74557|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74558|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74559|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74560|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74561|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74562|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74563|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74564|NCT01727713|E1|Reported Event|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
74565|NCT01727700|B4|Baseline|Total|Total of all reporting groups
74566|NCT01727700|B3|Baseline|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74567|NCT01727700|B2|Baseline|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74568|NCT01727700|B1|Baseline|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74569|NCT01727700|P3|Participant Flow|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74570|NCT01727700|P2|Participant Flow|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74571|NCT01727700|P1|Participant Flow|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74572|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74701|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74573|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74574|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74575|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74576|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74577|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74578|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74579|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74580|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74581|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74582|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74583|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74584|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74585|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74586|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74587|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74588|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74589|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74590|NCT01727700|E3|Reported Event|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
74591|NCT01727700|E2|Reported Event|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74702|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74592|NCT01727700|E1|Reported Event|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
74593|NCT01727258|B4|Baseline|Total|Total of all reporting groups
74594|NCT01727258|B3|Baseline|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
74595|NCT01727258|B2|Baseline|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
74596|NCT01727258|B1|Baseline|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
74597|NCT01727258|P3|Participant Flow|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
74598|NCT01727258|P2|Participant Flow|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
74599|NCT01727258|P1|Participant Flow|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
74600|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74601|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74602|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74603|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74604|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74605|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74606|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74607|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74608|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74609|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74610|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74611|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74612|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74613|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74614|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74615|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
74616|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
74617|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
74618|NCT01727258|E3|Reported Event|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
74619|NCT01727258|E2|Reported Event|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
74620|NCT01727258|E1|Reported Event|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
74621|NCT01727180|B1|Baseline|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
74622|NCT01727180|P1|Participant Flow|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
74623|NCT01727180|O1|Outcome|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
74624|NCT01727180|E1|Reported Event|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
74625|NCT01727167|B3|Baseline|Total|Total of all reporting groups
74626|NCT01727167|B2|Baseline|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
74627|NCT01727167|B1|Baseline|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
74628|NCT01727167|P2|Participant Flow|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
74629|NCT01727167|P1|Participant Flow|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
74630|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
74631|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
74632|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
74633|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
74634|NCT01727167|E2|Reported Event|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
74635|NCT01727167|E1|Reported Event|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
74636|NCT01727141|B5|Baseline|Total|Total of all reporting groups
74637|NCT01727141|B4|Baseline|Placebo|b.i.d
74638|NCT01727141|B3|Baseline|NVA237|12.5 ug b.i.d.
74639|NCT01727141|B2|Baseline|QAB149|27.5 ug b.i.d.
74640|NCT01727141|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74641|NCT01727141|P4|Participant Flow|Placebo|b.i.d
74642|NCT01727141|P3|Participant Flow|NVA237|12.5 ug b.i.d.
74643|NCT01727141|P2|Participant Flow|QAB149|27.5 ug b.i.d.
74644|NCT01727141|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74645|NCT01727141|O4|Outcome|Placebo|b.i.d
74646|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74647|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74648|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74649|NCT01727141|O4|Outcome|Placebo|b.i.d
74650|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74651|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74652|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74653|NCT01727141|O4|Outcome|Placebo|b.i.d
74654|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74655|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74656|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74657|NCT01727141|O4|Outcome|Placebo|b.i.d
74658|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74659|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74660|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74661|NCT01727141|O4|Outcome|Placebo|b.i.d
74662|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74663|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74664|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74665|NCT01727141|O4|Outcome|Placebo|b.i.d
74666|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74667|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74668|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74669|NCT01727141|O4|Outcome|Placebo|b.i.d
74670|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74671|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74672|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74673|NCT01727141|O4|Outcome|Placebo|b.i.d
74674|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74675|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74676|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74677|NCT01727141|O4|Outcome|Placebo|b.i.d
74678|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74679|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74680|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74681|NCT01727141|O4|Outcome|Placebo|b.i.d
74682|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74683|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74684|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74685|NCT01727141|O4|Outcome|Placebo|b.i.d
74686|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
74687|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
74688|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74689|NCT01727141|E4|Reported Event|Placebo|b.i.d
74690|NCT01727141|E3|Reported Event|NVA237|12.5 ug b.i.d.
74691|NCT01727141|E2|Reported Event|QAB149|27.5 ug b.i.d.
74692|NCT01727141|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
74693|NCT01727024|B1|Baseline|All Randomized Participants|All participants who were randomized either to sequence 1 or sequence 2
74694|NCT01727024|P2|Participant Flow|Tiotropium Respimat® First, Then Indacaterol Breezhaler®|In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74695|NCT01727024|P1|Participant Flow|Indacaterol Breezhaler® First, Then Tiotropium Respimat®|In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74696|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74697|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74698|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74915|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
74704|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74705|NCT01727024|E2|Reported Event|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
74706|NCT01727024|E1|Reported Event|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
74707|NCT01726621|B1|Baseline|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
74708|NCT01726621|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
74709|NCT01726621|O1|Outcome|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
74710|NCT01726621|E1|Reported Event|Insulin Dependent Diabetics|"Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter~Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks."
74711|NCT01726517|B6|Baseline|Total|Total of all reporting groups
74712|NCT01726517|B5|Baseline|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74713|NCT01726517|B4|Baseline|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74714|NCT01726517|B3|Baseline|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74715|NCT01726517|B2|Baseline|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74716|NCT01726517|B1|Baseline|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74717|NCT01726517|P5|Participant Flow|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74718|NCT01726517|P4|Participant Flow|LDV/SOF 12 Weeks (TE)|Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74719|NCT01726517|P3|Participant Flow|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74720|NCT01726517|P2|Participant Flow|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
74721|NCT01726517|P1|Participant Flow|LDV/SOF 8 Weeks (TN)|Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
74722|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74723|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74724|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74725|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74726|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74727|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74728|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74729|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74730|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74731|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74732|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74733|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74734|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74735|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74736|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74737|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74738|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74739|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74740|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74741|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74742|NCT01726517|E5|Reported Event|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
74743|NCT01726517|E4|Reported Event|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74744|NCT01726517|E3|Reported Event|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
74745|NCT01726517|E2|Reported Event|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
74746|NCT01726517|E1|Reported Event|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
74747|NCT01726504|B3|Baseline|Total|Total of all reporting groups
74748|NCT01726504|B2|Baseline|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
74749|NCT01726504|B1|Baseline|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
74750|NCT01726504|P2|Participant Flow|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
74751|NCT01726504|P1|Participant Flow|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
74752|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74753|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74791|NCT01726335|E1|Reported Event|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74754|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74755|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74756|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74757|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74758|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74759|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74760|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74792|NCT01726049|B3|Baseline|Total|Total of all reporting groups
74793|NCT01726049|B2|Baseline|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74794|NCT01726049|B1|Baseline|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74795|NCT01726049|P2|Participant Flow|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74796|NCT01726049|P1|Participant Flow|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74761|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74762|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74763|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74764|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74765|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74766|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74767|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74797|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74798|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74799|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74800|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74801|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74768|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74769|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74770|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74771|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74772|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74773|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74774|NCT01726504|E2|Reported Event|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
74802|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74803|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74804|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74805|NCT01726049|E2|Reported Event|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
74806|NCT01726049|E1|Reported Event|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
74775|NCT01726504|E1|Reported Event|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
74776|NCT01726335|B1|Baseline|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74777|NCT01726335|P1|Participant Flow|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74778|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74779|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74780|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74781|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74782|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74783|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74784|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74785|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74786|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74787|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74788|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74789|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74790|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
74807|NCT01726023|B3|Baseline|Total|Total of all reporting groups
74809|NCT01726023|B1|Baseline|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74810|NCT01726023|P2|Participant Flow|Meropenem|Meropenem powder for solution for infusion 1000mg
74811|NCT01726023|P1|Participant Flow|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74812|NCT01726023|O6|Outcome|Avibactam(3)|300-360 minutes after
74813|NCT01726023|O5|Outcome|Ceftazidime(3)|300-360 minutes after
74814|NCT01726023|O4|Outcome|Avibactam(2)|30-90 minutes after
74815|NCT01726023|O3|Outcome|Ceftazidime(2)|30-90 minutes after
74816|NCT01726023|O2|Outcome|Avibactam(1)|15 minutes before or after
74817|NCT01726023|O1|Outcome|Ceftazidime(1)|15 minutes before or after
74818|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74819|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74820|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74821|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74822|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74823|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74824|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74825|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74826|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74827|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74828|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74829|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74830|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74831|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74832|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74833|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74834|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74835|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74836|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74837|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74838|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74839|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74840|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74841|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74842|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74843|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74844|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74845|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74846|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74847|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74848|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74849|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74850|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74851|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74852|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74853|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74854|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74855|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
74856|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74857|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74858|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74859|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74860|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74861|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74862|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74863|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74864|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74865|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74866|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74867|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74868|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74869|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74870|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74871|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74872|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74873|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74874|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74875|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74876|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74877|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74878|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74879|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74880|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74881|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74882|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74883|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74884|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74885|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74886|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74887|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74888|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74889|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74890|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74891|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74892|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74893|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74894|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74895|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74896|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
74897|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
74898|NCT01726023|E2|Reported Event|Meropenem|Meropenem powder for solution for infusion 1000mg
74899|NCT01726023|E1|Reported Event|CAZ-AVI Plus Metronidazole|
74900|NCT01725984|B3|Baseline|Total|Total of all reporting groups
74926|NCT01725984|E1|Reported Event|AdVance|Subjects implanted with the AdVance Male Sling
74927|NCT01725529|B4|Baseline|Total|Total of all reporting groups
74928|NCT01725529|B3|Baseline|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74929|NCT01725529|B2|Baseline|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74930|NCT01725529|B1|Baseline|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74931|NCT01725529|P3|Participant Flow|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74932|NCT01725529|P2|Participant Flow|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74933|NCT01725529|P1|Participant Flow|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74934|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74935|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74936|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74937|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74938|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74939|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74940|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74941|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74942|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74943|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74944|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74945|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74946|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74947|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
75157|NCT01724216|O1|Outcome|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
74948|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74949|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74950|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74951|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74952|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74953|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74954|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74955|NCT01725529|E3|Reported Event|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74956|NCT01725529|E2|Reported Event|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
74957|NCT01725529|E1|Reported Event|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
74958|NCT01725451|B1|Baseline|Testosterone 2% Solution|Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
74959|NCT01725451|P4|Participant Flow|Sequence 4|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
74960|NCT01725451|P3|Participant Flow|Sequence 3|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
74961|NCT01725451|P2|Participant Flow|Sequence 2|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
74996|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74997|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74998|NCT01725386|E2|Reported Event|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74999|NCT01725386|E1|Reported Event|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
75000|NCT01725308|B4|Baseline|Total|Total of all reporting groups
74962|NCT01725451|P1|Participant Flow|Sequence 1|30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
74963|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74964|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
74965|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74966|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .
74967|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74968|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
74969|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74970|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
74971|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74972|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74973|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74974|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
74975|NCT01725451|E6|Reported Event|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74976|NCT01725451|E5|Reported Event|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
74977|NCT01725451|E4|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74978|NCT01725451|E3|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74979|NCT01725451|E2|Reported Event|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
74980|NCT01725451|E1|Reported Event|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
74981|NCT01725386|B3|Baseline|Total|Total of all reporting groups
74982|NCT01725386|B2|Baseline|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74983|NCT01725386|B1|Baseline|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74984|NCT01725386|P2|Participant Flow|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74985|NCT01725386|P1|Participant Flow|Monotherapy|Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
74986|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74987|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74988|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74989|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74990|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74991|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74992|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74993|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
74994|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
74995|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
75895|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75001|NCT01725308|B3|Baseline|Treatment Period I: FK949E 300 mg|Participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75002|NCT01725308|B2|Baseline|Treatment Period I: FK949E 150 mg|Participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75003|NCT01725308|B1|Baseline|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75004|NCT01725308|P3|Participant Flow|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75005|NCT01725308|P2|Participant Flow|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75006|NCT01725308|P1|Participant Flow|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75007|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75008|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75009|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75010|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75011|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75012|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75013|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75014|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75015|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75016|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75017|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75018|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75019|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75020|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75021|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75022|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75023|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75024|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75025|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75026|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75027|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75028|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75029|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75030|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75031|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75032|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75033|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75034|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75035|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75036|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75037|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75038|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75039|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75040|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75041|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75042|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75043|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75044|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75045|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75046|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75047|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75048|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75049|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75050|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75051|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75052|NCT01725308|E3|Reported Event|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
75053|NCT01725308|E2|Reported Event|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
75054|NCT01725308|E1|Reported Event|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
75055|NCT01725282|B5|Baseline|Total|Total of all reporting groups
75056|NCT01725282|B4|Baseline|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75057|NCT01725282|B3|Baseline|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75058|NCT01725282|B2|Baseline|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75059|NCT01725282|B1|Baseline|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75060|NCT01725282|P4|Participant Flow|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75061|NCT01725282|P3|Participant Flow|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75062|NCT01725282|P2|Participant Flow|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75063|NCT01725282|P1|Participant Flow|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75064|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75065|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75066|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75067|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75068|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75069|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75070|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75071|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75072|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75073|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75074|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75075|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75076|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75077|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75078|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75079|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75080|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75081|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75082|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75083|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75084|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75085|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75086|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75087|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75088|NCT01725282|E4|Reported Event|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
75089|NCT01725282|E3|Reported Event|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
75090|NCT01725282|E2|Reported Event|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
75091|NCT01725282|E1|Reported Event|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
75092|NCT01725217|B4|Baseline|Total|Total of all reporting groups
75093|NCT01725217|B3|Baseline|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75094|NCT01725217|B2|Baseline|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75095|NCT01725217|B1|Baseline|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75096|NCT01725217|P3|Participant Flow|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75097|NCT01725217|P2|Participant Flow|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75098|NCT01725217|P1|Participant Flow|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75099|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75100|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75101|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75102|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
75103|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75104|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75105|NCT01725217|O2|Outcome|≥6 to ≤10 Years|Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM
75106|NCT01725217|O1|Outcome|Overall (≥6 Years)|All subjects ≥6 years of age who received one vaccination of MenACWY-CRM
75107|NCT01725217|O2|Outcome|≥2 to ≤3 Years|Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM
75108|NCT01725217|O1|Outcome|≥2 to ≤5 Years|Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM
75109|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75110|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75111|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75112|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
75113|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75114|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75115|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75116|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
75117|NCT01725217|O3|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75118|NCT01725217|O2|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75119|NCT01725217|O1|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75120|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
75121|NCT01725217|E4|Reported Event|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
75122|NCT01725217|E3|Reported Event|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
75123|NCT01725217|E2|Reported Event|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
75124|NCT01725217|E1|Reported Event|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
75125|NCT01724528|B3|Baseline|Total|Total of all reporting groups
75156|NCT01724216|P1|Participant Flow|Single Arm|Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
75126|NCT01724528|B2|Baseline|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75127|NCT01724528|B1|Baseline|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75128|NCT01724528|P2|Participant Flow|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75129|NCT01724528|P1|Participant Flow|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75130|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75131|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75132|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75133|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75134|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75135|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75136|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75137|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75138|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75139|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75140|NCT01724528|E2|Reported Event|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
75141|NCT01724528|E1|Reported Event|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
75142|NCT01724359|B1|Baseline|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75143|NCT01724359|P1|Participant Flow|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75144|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75145|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75146|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75147|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75148|NCT01724359|O2|Outcome|Patients at Week 26: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75149|NCT01724359|O1|Outcome|Patients at Baseline: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75150|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75151|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75152|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75153|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75154|NCT01724359|E1|Reported Event|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
75155|NCT01724216|B1|Baseline|Single Arm|Magnetic Resonance Image Collection Using Innovative Pulse Sequences
75158|NCT01724216|E1|Reported Event|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
75159|NCT01724177|B1|Baseline|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
75160|NCT01724177|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
75161|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75162|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75163|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75164|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
75165|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75166|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75167|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75168|NCT01724177|E1|Reported Event|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
75169|NCT01724021|B3|Baseline|Total|Total of all reporting groups
75170|NCT01724021|B2|Baseline|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75171|NCT01724021|B1|Baseline|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75172|NCT01724021|P2|Participant Flow|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75173|NCT01724021|P1|Participant Flow|Arm A|Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75174|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75175|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75176|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75177|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75178|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75192|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75365|NCT01722487|E2|Reported Event|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75179|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75180|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75181|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75182|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75183|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75184|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75185|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75186|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75187|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75188|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75189|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75190|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75191|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75222|NCT01723722|E1|Reported Event|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
75193|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75194|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75195|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75196|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75197|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75198|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75199|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75200|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75201|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75202|NCT01724021|E2|Reported Event|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75203|NCT01724021|E1|Reported Event|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
75204|NCT01723904|B1|Baseline|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75205|NCT01723904|P1|Participant Flow|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75223|NCT01723397|B3|Baseline|Total|Total of all reporting groups
75206|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75207|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75208|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75209|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75210|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75211|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75212|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75213|NCT01723904|E1|Reported Event|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
75214|NCT01723722|B3|Baseline|Total|Total of all reporting groups
75215|NCT01723722|B2|Baseline|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
75216|NCT01723722|B1|Baseline|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
75217|NCT01723722|P2|Participant Flow|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
75218|NCT01723722|P1|Participant Flow|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
75219|NCT01723722|O2|Outcome|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
75220|NCT01723722|O1|Outcome|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
75221|NCT01723722|E2|Reported Event|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
75224|NCT01723397|B2|Baseline|Placebo Spray, Then Nasaleze Spray|"This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
75225|NCT01723397|B1|Baseline|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
75226|NCT01723397|P2|Participant Flow|Placebo Spray, Then Nasaleze Spray|"This group first received Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
75227|NCT01723397|P1|Participant Flow|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
75228|NCT01723397|O2|Outcome|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
75229|NCT01723397|O1|Outcome|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
75230|NCT01723397|E2|Reported Event|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
75231|NCT01723397|E1|Reported Event|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
75232|NCT01723254|B9|Baseline|Total|Total of all reporting groups
75233|NCT01723254|B8|Baseline|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75234|NCT01723254|B7|Baseline|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75235|NCT01723254|B6|Baseline|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75236|NCT01723254|B5|Baseline|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75237|NCT01723254|B4|Baseline|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75238|NCT01723254|B3|Baseline|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75239|NCT01723254|B2|Baseline|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75240|NCT01723254|B1|Baseline|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75241|NCT01723254|P8|Participant Flow|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75366|NCT01722487|E1|Reported Event|PCI-32765|Ibrutinib 420 mg daily.
75242|NCT01723254|P7|Participant Flow|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75243|NCT01723254|P6|Participant Flow|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75244|NCT01723254|P5|Participant Flow|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75245|NCT01723254|P4|Participant Flow|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75246|NCT01723254|P3|Participant Flow|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75247|NCT01723254|P2|Participant Flow|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75248|NCT01723254|P1|Participant Flow|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75249|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75250|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75251|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75252|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75253|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75254|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75255|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75256|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75257|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75258|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75259|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75260|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75261|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75262|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75263|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75264|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75265|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75266|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75267|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75268|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75269|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75270|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75271|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75272|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75273|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75274|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75275|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75276|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75277|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75278|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75279|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75280|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75281|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75282|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75283|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75284|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75285|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75286|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75287|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75288|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
75289|NCT01723254|E8|Reported Event|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
75290|NCT01723254|E7|Reported Event|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75291|NCT01723254|E6|Reported Event|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75292|NCT01723254|E5|Reported Event|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75293|NCT01723254|E4|Reported Event|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75294|NCT01723254|E3|Reported Event|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75295|NCT01723254|E2|Reported Event|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75296|NCT01723254|E1|Reported Event|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
75297|NCT01723228|B3|Baseline|Total|Total of all reporting groups
75298|NCT01723228|B2|Baseline|Placebo|Placebo oral tablets once daily for 24 weeks
75299|NCT01723228|B1|Baseline|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75300|NCT01723228|P2|Participant Flow|Placebo|Placebo oral tablets once daily for 24 weeks
75301|NCT01723228|P1|Participant Flow|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75302|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75303|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75304|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75305|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75306|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75307|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75308|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75309|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75310|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75311|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75312|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
75313|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75314|NCT01723228|E2|Reported Event|Placebo|Placebo oral tablets once daily for 24 weeks
75315|NCT01723228|E1|Reported Event|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
75316|NCT01722994|B3|Baseline|Total|Total of all reporting groups
75317|NCT01722994|B2|Baseline|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75318|NCT01722994|B1|Baseline|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75319|NCT01722994|P2|Participant Flow|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75320|NCT01722994|P1|Participant Flow|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75321|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75322|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75323|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75324|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75325|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75326|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75327|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75328|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75329|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75330|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75331|NCT01722994|E2|Reported Event|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
75332|NCT01722994|E1|Reported Event|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
75333|NCT01722734|B4|Baseline|Total|Total of all reporting groups
75334|NCT01722734|B3|Baseline|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
75335|NCT01722734|B2|Baseline|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
75336|NCT01722734|B1|Baseline|Control|Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
75337|NCT01722734|P3|Participant Flow|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
75338|NCT01722734|P2|Participant Flow|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
75339|NCT01722734|P1|Participant Flow|Control|Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
75340|NCT01722734|O3|Outcome|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
75341|NCT01722734|O2|Outcome|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
75342|NCT01722734|O1|Outcome|Control|Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
75343|NCT01722734|E3|Reported Event|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
75344|NCT01722734|E2|Reported Event|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
75345|NCT01722734|E1|Reported Event|Control|Patients in this group received only a generic malaria message at the end of the study.
75346|NCT01722487|B3|Baseline|Total|Total of all reporting groups
75347|NCT01722487|B2|Baseline|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75348|NCT01722487|B1|Baseline|Ibrutinib|Ibrutinib 420 mg daily.
75349|NCT01722487|P2|Participant Flow|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75350|NCT01722487|P1|Participant Flow|Ibrutinib|Ibrutinib 420 mg daily.
75351|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75352|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75353|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75354|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75355|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75356|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75357|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75358|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75359|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75360|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75361|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
75362|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75363|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
75364|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
75896|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75367|NCT01722435|B1|Baseline|OST Completers|"The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients’ state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or – if patients stayed in treatment – at the end of the 18-months study period).~At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."
75368|NCT01722435|P1|Participant Flow|OST Completers|"Patients who are likely to complete OST during the next 12 or 18 months~Opiate Substitution Treatment"
75369|NCT01722435|O1|Outcome|Still in OST Completers|Patients still in OST during the whole study period.
75370|NCT01722435|O1|Outcome|OST Drop-outs|Patients dropped out of OST during 12 or 18 months.
75371|NCT01722435|O1|Outcome|OST Completers|Patients completed OST during 12 or 18 months.
75372|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months.
75373|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
75374|NCT01722435|E1|Reported Event|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
75375|NCT01722266|B5|Baseline|Total|Total of all reporting groups
75376|NCT01722266|B4|Baseline|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75377|NCT01722266|B3|Baseline|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75378|NCT01722266|B2|Baseline|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75379|NCT01722266|B1|Baseline|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75380|NCT01722266|P4|Participant Flow|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75381|NCT01722266|P3|Participant Flow|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75382|NCT01722266|P2|Participant Flow|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75383|NCT01722266|P1|Participant Flow|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75384|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75385|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75386|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75427|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
75580|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75387|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75388|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75389|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75390|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75391|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75392|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75393|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75394|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75395|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75396|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75397|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75398|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75399|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75400|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75401|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75402|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75428|NCT01722097|E2|Reported Event|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
75403|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75404|NCT01722266|E4|Reported Event|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75405|NCT01722266|E3|Reported Event|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75406|NCT01722266|E2|Reported Event|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
75407|NCT01722266|E1|Reported Event|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
75408|NCT01722162|B3|Baseline|Total|Total of all reporting groups
75409|NCT01722162|B2|Baseline|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
75410|NCT01722162|B1|Baseline|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75411|NCT01722162|P2|Participant Flow|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
75412|NCT01722162|P1|Participant Flow|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75413|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75414|NCT01722162|O2|Outcome|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
75415|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75416|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75417|NCT01722162|E2|Reported Event|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
75418|NCT01722162|E1|Reported Event|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
75419|NCT01722097|B3|Baseline|Total|Total of all reporting groups
75420|NCT01722097|B2|Baseline|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
75421|NCT01722097|B1|Baseline|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
75422|NCT01722097|P2|Participant Flow|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
75423|NCT01722097|P1|Participant Flow|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
75424|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
75425|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
75426|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
75429|NCT01722097|E1|Reported Event|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
75430|NCT01722071|B1|Baseline|Participants|Each participant will complete baseline assessments prior to being studied using fMRI
75431|NCT01722071|P2|Participant Flow|Oxytocin Then Placebo|"These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
75432|NCT01722071|P1|Participant Flow|Placebo Then Oxytocin|"These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
75433|NCT01722071|O2|Outcome|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
75434|NCT01722071|O1|Outcome|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
75435|NCT01722071|E2|Reported Event|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
75436|NCT01722071|E1|Reported Event|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
75437|NCT01721967|B1|Baseline|Ranolazine|Ranolazine, 500 mg for 60 days
75438|NCT01721967|P1|Participant Flow|Ranolazine|Ranolazine, 500 mg for 60 days
75439|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75440|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75441|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75442|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75443|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75444|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
75445|NCT01721967|E1|Reported Event|Ranolazine|Ranolazine, 500 mg for 60 days
75446|NCT01721837|B1|Baseline|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
75447|NCT01721837|P1|Participant Flow|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
75448|NCT01721837|O1|Outcome|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
75449|NCT01721837|E1|Reported Event|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
75450|NCT01721772|B3|Baseline|Total|Total of all reporting groups
75451|NCT01721772|B2|Baseline|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75452|NCT01721772|B1|Baseline|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75453|NCT01721772|P2|Participant Flow|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75454|NCT01721772|P1|Participant Flow|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75455|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75456|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75457|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75458|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75459|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75460|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75461|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75462|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75463|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75464|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75465|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75466|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75467|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75468|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75469|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75470|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75471|NCT01721772|E2|Reported Event|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75472|NCT01721772|E1|Reported Event|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
75473|NCT01721759|B1|Baseline|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75474|NCT01721759|P1|Participant Flow|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75475|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75476|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75477|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75478|NCT01721759|E1|Reported Event|NivolumAB, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
75479|NCT01721564|B1|Baseline|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
75480|NCT01721564|P1|Participant Flow|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
75481|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
75482|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
75483|NCT01721564|E1|Reported Event|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
75484|NCT01721330|B3|Baseline|Total|Total of all reporting groups
75485|NCT01721330|B2|Baseline|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
75486|NCT01721330|B1|Baseline|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
75897|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75487|NCT01721330|P2|Participant Flow|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
75488|NCT01721330|P1|Participant Flow|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
75489|NCT01721330|O2|Outcome|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
75490|NCT01721330|O1|Outcome|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
75491|NCT01721330|E2|Reported Event|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
75492|NCT01721330|E1|Reported Event|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
75493|NCT01721317|B3|Baseline|Total|Total of all reporting groups
75494|NCT01721317|B2|Baseline|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75495|NCT01721317|B1|Baseline|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75496|NCT01721317|P2|Participant Flow|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 milligrams (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75497|NCT01721317|P1|Participant Flow|Placebo|Participants received matching ezogabine/retigabine IR placebo orally three times a day (TID) in equally or unequally divided doses.
75498|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75499|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75500|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75501|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75502|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75503|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75504|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75505|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75506|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75507|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75508|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75509|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75510|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75511|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75512|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75513|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75514|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75515|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75516|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75517|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75518|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75519|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75520|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75521|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75522|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75523|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75524|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75525|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75526|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75527|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75528|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75529|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75530|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75531|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75532|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75533|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75534|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75535|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75536|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75537|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75538|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75539|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75540|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75541|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75542|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75543|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75544|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75545|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75546|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75547|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75548|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75549|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75550|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75551|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75552|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75553|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75579|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75554|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75555|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75556|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75557|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75558|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75559|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75560|NCT01721317|E2|Reported Event|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
75561|NCT01721317|E1|Reported Event|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
75562|NCT01721226|B3|Baseline|Total|Total of all reporting groups
75563|NCT01721226|B2|Baseline|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75564|NCT01721226|B1|Baseline|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75565|NCT01721226|P2|Participant Flow|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75566|NCT01721226|P1|Participant Flow|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75567|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75568|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75569|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75570|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75571|NCT01721226|E2|Reported Event|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75572|NCT01721226|E1|Reported Event|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
75573|NCT01721161|B3|Baseline|Total|Total of all reporting groups
75574|NCT01721161|B2|Baseline|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75575|NCT01721161|B1|Baseline|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75576|NCT01721161|P2|Participant Flow|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75577|NCT01721161|P1|Participant Flow|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75578|NCT01721161|O1|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75581|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75582|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75583|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75584|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75585|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75586|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75587|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75588|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75589|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75590|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75591|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75592|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75593|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75594|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75595|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75596|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75597|NCT01721161|E2|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75598|NCT01721161|E1|Reported Event|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
75599|NCT01721096|B3|Baseline|Total|Total of all reporting groups
75600|NCT01721096|B2|Baseline|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75601|NCT01721096|B1|Baseline|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75602|NCT01721096|P2|Participant Flow|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75603|NCT01721096|P1|Participant Flow|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75604|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75605|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75606|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75607|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75608|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75609|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75610|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75611|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75612|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75613|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75614|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75615|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75616|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75617|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75618|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75619|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75620|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75621|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75622|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75623|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75624|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75625|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75626|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75627|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75628|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75898|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75629|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75630|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75631|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75632|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75633|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75634|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75635|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75636|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75637|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75638|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75639|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75640|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75641|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75642|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75643|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75644|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75645|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75646|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75647|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75648|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75649|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75650|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75651|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75652|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75653|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75654|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75655|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75656|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75657|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75658|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75659|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75660|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75661|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75662|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75663|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75664|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75665|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75666|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75667|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75668|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75669|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75670|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75671|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75672|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75673|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75674|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75675|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75676|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75677|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75678|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75679|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75680|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75681|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75682|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75683|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75684|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75685|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75686|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75687|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75688|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
75689|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
75690|NCT01721096|E2|Reported Event|XIENCE PRIME - Core Size (CS)|XIENCE PRIME - Core Size: Core Size- 213 patients with 8, 12, 15, 18 or 23 mm stents.
75691|NCT01721096|E1|Reported Event|XIENCE PRIME - Long Length (LL)|XIENCE PRIME - Long Length (LL): Long Length- 323 patients receiving LL stent in 28, 33, or 38 mm length.
75692|NCT01721070|B1|Baseline|SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg|"Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.~Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
75693|NCT01721070|P1|Participant Flow|SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg|"Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2.~Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil."
75694|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
75695|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
75696|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
75697|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
75698|NCT01721070|E2|Reported Event|Ketoconazole 400 mg + SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
75699|NCT01721070|E1|Reported Event|SUF NT 15 mcg|"One SUF NT 15 mcg administered sublingually.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
75700|NCT01720797|B3|Baseline|Total|Total of all reporting groups
75701|NCT01720797|B2|Baseline|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
75702|NCT01720797|B1|Baseline|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
75703|NCT01720797|P2|Participant Flow|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
75723|NCT01720251|O2|Outcome|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
75724|NCT01720251|O1|Outcome|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
75725|NCT01720251|E3|Reported Event|AllerT 100 µg|All patients having received at least one injection of Allert 100 µg (Safety Set)
75704|NCT01720797|P1|Participant Flow|Micro-osteoperforation|"Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.~Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.~Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
75705|NCT01720797|O2|Outcome|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
75706|NCT01720797|O1|Outcome|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
75707|NCT01720797|E2|Reported Event|Non Micro-osteoperforation|"Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
75708|NCT01720797|E1|Reported Event|Micro-osteoperforation|Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
75709|NCT01720602|B1|Baseline|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75710|NCT01720602|P1|Participant Flow|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75711|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75712|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75713|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75714|NCT01720602|E1|Reported Event|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
75715|NCT01720251|B4|Baseline|Total|Total of all reporting groups
75716|NCT01720251|B3|Baseline|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
75717|NCT01720251|B2|Baseline|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
75718|NCT01720251|B1|Baseline|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
75719|NCT01720251|P3|Participant Flow|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
75720|NCT01720251|P2|Participant Flow|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
75721|NCT01720251|P1|Participant Flow|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
75722|NCT01720251|O3|Outcome|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
75822|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75726|NCT01720251|E2|Reported Event|Allert 50 µg|All patients having received at least one injection of Allert 50 µg (Safety Set)
75727|NCT01720251|E1|Reported Event|Placebo|All patients having received at least one injection of Placebo (Safety Set)
75728|NCT01719757|B1|Baseline|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75729|NCT01719757|P1|Participant Flow|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75730|NCT01719757|O2|Outcome|Subject|For overall satisfaction assessement of oxycodone/naloxone by subject
75731|NCT01719757|O1|Outcome|Investigator|For overall satisfaction assessement of oxycodone/naloxone by investigator
75732|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75733|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75734|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75735|NCT01719757|E1|Reported Event|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
75736|NCT01719172|B1|Baseline|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75737|NCT01719172|P1|Participant Flow|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75738|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75739|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75740|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75741|NCT01719172|E1|Reported Event|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
75742|NCT01719003|B9|Baseline|Total|Total of all reporting groups
75743|NCT01719003|B8|Baseline|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75744|NCT01719003|B7|Baseline|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75745|NCT01719003|B6|Baseline|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75746|NCT01719003|B5|Baseline|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75747|NCT01719003|B4|Baseline|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75748|NCT01719003|B3|Baseline|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75749|NCT01719003|B2|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75750|NCT01719003|B1|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75751|NCT01719003|P9|Participant Flow|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
75752|NCT01719003|P8|Participant Flow|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75753|NCT01719003|P7|Participant Flow|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75754|NCT01719003|P6|Participant Flow|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75755|NCT01719003|P5|Participant Flow|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75756|NCT01719003|P4|Participant Flow|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75757|NCT01719003|P3|Participant Flow|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75758|NCT01719003|P2|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75759|NCT01719003|P1|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75760|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75761|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75762|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75763|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75764|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75765|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75766|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75767|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75768|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75769|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75770|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75771|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75894|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75772|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75773|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75774|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75775|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75776|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75777|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75778|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75779|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75780|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75781|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75782|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75783|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75784|NCT01719003|E9|Reported Event|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
75785|NCT01719003|E8|Reported Event|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
75786|NCT01719003|E7|Reported Event|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
75787|NCT01719003|E6|Reported Event|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
75788|NCT01719003|E5|Reported Event|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
75789|NCT01719003|E4|Reported Event|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
75790|NCT01719003|E3|Reported Event|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
75791|NCT01719003|E2|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
75792|NCT01719003|E1|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
75793|NCT01718691|B3|Baseline|Total|Total of all reporting groups
75794|NCT01718691|B2|Baseline|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75795|NCT01718691|B1|Baseline|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75796|NCT01718691|P2|Participant Flow|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
75797|NCT01718691|P1|Participant Flow|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
75798|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75799|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
75800|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75801|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75802|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75803|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75804|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75805|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75806|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75807|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75808|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75809|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75810|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75811|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75812|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75813|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75814|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75815|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75816|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75817|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75818|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75819|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
75820|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
75821|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
75823|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75824|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75825|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
75826|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
75827|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
75828|NCT01718691|E1|Reported Event|SyB L-0501＋Rituximab|"Drug: SyB L-0501~A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.~Drug: rituximab~A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0."
75829|NCT01718535|B11|Baseline|Total|Total of all reporting groups
75830|NCT01718535|B10|Baseline|*3/*17 CYP2C19 Genotype|
75831|NCT01718535|B9|Baseline|*2/*17 CYP2C19 Genotype|
75832|NCT01718535|B8|Baseline|*2/*3 CYP2C19 Genotype|
75833|NCT01718535|B7|Baseline|*17/*17 CYP2C19 Genotype|
75834|NCT01718535|B6|Baseline|*1/*17 CYP2C19 Genotype|
75835|NCT01718535|B5|Baseline|*3/*3 CYP2C19 Genotype|
75836|NCT01718535|B4|Baseline|*1/*3 CYP2C19 Genotype|
75837|NCT01718535|B3|Baseline|*2/*2 CYP2C19 Genotype|
75838|NCT01718535|B2|Baseline|*1/*2 CYP2C19 Genotype|
75839|NCT01718535|B1|Baseline|*1/*1 CYP2C19 Genotype|
75840|NCT01718535|P10|Participant Flow|*3/*17 CYP2C19 Genotype|
75841|NCT01718535|P9|Participant Flow|*2/*17 CYP2C19 Genotype|
75842|NCT01718535|P8|Participant Flow|*2/*3 CYP2C19 Genotype|
75843|NCT01718535|P7|Participant Flow|*17/*17 CYP2C19 Genotype|
75844|NCT01718535|P6|Participant Flow|*1/*17 CYP2C19 Genotype|
75845|NCT01718535|P5|Participant Flow|*3/*3 CYP2C19 Genotype|
75846|NCT01718535|P4|Participant Flow|*1/*3 CYP2C19 Genotype|
75847|NCT01718535|P3|Participant Flow|*2/*2 CYP2C19 Genotype|
75848|NCT01718535|P2|Participant Flow|*1/*2 CYP2C19 Genotype|
75849|NCT01718535|P1|Participant Flow|*1/*1 CYP2C19 Genotype|
75850|NCT01718535|O10|Outcome|*3/*17 CYP2C19 Genotype|
75851|NCT01718535|O9|Outcome|*2/*17 CYP2C19 Genotype|
75852|NCT01718535|O8|Outcome|*2/*3 CYP2C19 Genotype|
75853|NCT01718535|O7|Outcome|*17/*17 CYP2C19 Genotype|
75854|NCT01718535|O6|Outcome|*1/*17 CYP2C19 Genotype|
75855|NCT01718535|O5|Outcome|*3/*3 CYP2C19 Genotype|
75856|NCT01718535|O4|Outcome|*1/*3 CYP2C19 Genotype|
75857|NCT01718535|O3|Outcome|*2/*2 CYP2C19 Genotype|
75858|NCT01718535|O2|Outcome|*1/*2 CYP2C19 Genotype|
75859|NCT01718535|O1|Outcome|*1/*1 CYP2C19 Genotype|
75860|NCT01718535|E10|Reported Event|*3/*17 CYP2C19 Genotype|
75861|NCT01718535|E9|Reported Event|*2/*17 CYP2C19 Genotype|
75862|NCT01718535|E8|Reported Event|*2/*3 CYP2C19 Genotype|
75863|NCT01718535|E7|Reported Event|*17/*17 CYP2C19 Genotype|
75864|NCT01718535|E6|Reported Event|*1/*17 CYP2C19 Genotype|
75865|NCT01718535|E5|Reported Event|*3/*3 CYP2C19 Genotype|
75866|NCT01718535|E4|Reported Event|*1/*3 CYP2C19 Genotype|
75867|NCT01718535|E3|Reported Event|*2/*2 CYP2C19 Genotype|
75868|NCT01718535|E2|Reported Event|*1/*2 CYP2C19 Genotype|
75869|NCT01718535|E1|Reported Event|*1/*1 CYP2C19 Genotype|
75870|NCT01718509|B3|Baseline|Total|Total of all reporting groups
75871|NCT01718509|B2|Baseline|SPD489|
75872|NCT01718509|B1|Baseline|PLACEBO|
75873|NCT01718509|P2|Participant Flow|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75874|NCT01718509|P1|Participant Flow|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75875|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75876|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75877|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75878|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75879|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75880|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75881|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75882|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75883|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75884|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75885|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75886|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75887|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75888|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75889|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75890|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75891|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75892|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75893|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75899|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75900|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75901|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75902|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75903|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75904|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75905|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75906|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75907|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75908|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75909|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75910|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75911|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75912|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75913|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75914|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75915|NCT01718509|E2|Reported Event|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
75916|NCT01718509|E1|Reported Event|PLACEBO|Administered once-daily, orally, for up to 12 weeks
75917|NCT01718483|B3|Baseline|Total|Total of all reporting groups
75918|NCT01718483|B2|Baseline|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75919|NCT01718483|B1|Baseline|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75920|NCT01718483|P2|Participant Flow|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75921|NCT01718483|P1|Participant Flow|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
75922|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75923|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75924|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75925|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75926|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75927|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75928|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75929|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75930|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75931|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75932|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75933|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75934|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75935|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75936|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75937|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75938|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75939|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75940|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75941|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75942|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75943|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75944|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75945|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75946|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75947|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75948|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75949|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75950|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75951|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75952|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75953|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75954|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75955|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75956|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75957|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75958|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75959|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75960|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75961|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75962|NCT01718483|E2|Reported Event|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
75963|NCT01718483|E1|Reported Event|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
75964|NCT01718028|B3|Baseline|Total|Total of all reporting groups
75965|NCT01718028|B2|Baseline|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75966|NCT01718028|B1|Baseline|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75967|NCT01718028|P2|Participant Flow|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75968|NCT01718028|P1|Participant Flow|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75969|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75970|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75971|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75972|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75973|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75974|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75975|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75976|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75977|NCT01718028|E2|Reported Event|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
75978|NCT01718028|E1|Reported Event|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
75979|NCT01717989|B1|Baseline|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
75980|NCT01717989|P1|Participant Flow|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
75981|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
75982|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
75983|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
75984|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
75985|NCT01717989|O1|Outcome|2010|From June through December 2010
75986|NCT01717989|O5|Outcome|December 2011|
75987|NCT01717989|O4|Outcome|September 2011|
75988|NCT01717989|O3|Outcome|June 2011|
75989|NCT01717989|O2|Outcome|March 2011|
75990|NCT01717989|O1|Outcome|December 2010|
75991|NCT01717989|O5|Outcome|December 2011|
75992|NCT01717989|O4|Outcome|September 2011|
75993|NCT01717989|O3|Outcome|June 2011|
75994|NCT01717989|O2|Outcome|March 2011|
75995|NCT01717989|O1|Outcome|December 2010|
75996|NCT01717989|O5|Outcome|December 2011|
75997|NCT01717989|O4|Outcome|September 2011|
75998|NCT01717989|O3|Outcome|June 2011|
75999|NCT01717989|O2|Outcome|March 2011|
76000|NCT01717989|O1|Outcome|December 2010|
76001|NCT01717989|O5|Outcome|December 2011|
76002|NCT01717989|O4|Outcome|September 2011|
76003|NCT01717989|O3|Outcome|June 2011|
76004|NCT01717989|O2|Outcome|March 2011|
76005|NCT01717989|O1|Outcome|December 2010|
76006|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
76007|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
76008|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
76009|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
76010|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
76011|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
76012|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
76013|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
76014|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
76015|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
76016|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
76036|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
76037|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
76038|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
76039|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
76040|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
76041|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
76042|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
76043|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
76044|NCT01717989|E1|Reported Event|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
76045|NCT01717872|B3|Baseline|Total|Total of all reporting groups
76046|NCT01717872|B2|Baseline|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76047|NCT01717872|B1|Baseline|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76048|NCT01717872|P2|Participant Flow|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76049|NCT01717872|P1|Participant Flow|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76050|NCT01717872|O2|Outcome|MAC Blade Lifting the Epiglottis|The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening
76051|NCT01717872|O1|Outcome|MAC Blade Lifting the Tongue|The MAC blade was inserted under the tongue and lifted to view the percent glottic opening
76052|NCT01717872|O2|Outcome|Miller Blade Lifting the Tongue|Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening
76053|NCT01717872|O1|Outcome|Miller Blade Lifting the Epiglottis|Miller blade was inserted under the epiglottis to lift it to view the glottic opening
76054|NCT01717872|O2|Outcome|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76055|NCT01717872|O1|Outcome|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76056|NCT01717872|E2|Reported Event|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76057|NCT01717872|E1|Reported Event|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
76058|NCT01717768|B11|Baseline|Total|Total of all reporting groups
76059|NCT01717768|B10|Baseline|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76060|NCT01717768|B9|Baseline|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76061|NCT01717768|B8|Baseline|Part 4 Cohort 2: 90 mg BID/ 90 mg TID|"Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76062|NCT01717768|B7|Baseline|Part 4 Cohort 1: 60 mg BID/ 60 mg TID|"Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76063|NCT01717768|B6|Baseline|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76083|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76240|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76064|NCT01717768|B5|Baseline|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76065|NCT01717768|B4|Baseline|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76066|NCT01717768|B3|Baseline|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76067|NCT01717768|B2|Baseline|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76068|NCT01717768|B1|Baseline|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76069|NCT01717768|P12|Participant Flow|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76070|NCT01717768|P11|Participant Flow|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76071|NCT01717768|P10|Participant Flow|Part 4 Cohort 2: 90 mg TID|Oral TSX-002 90 mg TID for 15 days
76072|NCT01717768|P9|Participant Flow|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76073|NCT01717768|P8|Participant Flow|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002 are capsules with testosterone as the active ingredient."
76074|NCT01717768|P7|Participant Flow|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76075|NCT01717768|P6|Participant Flow|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
76076|NCT01717768|P5|Participant Flow|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
76077|NCT01717768|P4|Participant Flow|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76078|NCT01717768|P3|Participant Flow|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76079|NCT01717768|P2|Participant Flow|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76080|NCT01717768|P1|Participant Flow|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76081|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76082|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76289|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76084|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76085|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76086|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
76087|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76088|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76089|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76090|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76091|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
76092|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76093|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76094|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76095|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76096|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76097|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76098|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76099|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76100|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
76101|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76102|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76103|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76104|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76105|NCT01717768|E12|Reported Event|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76106|NCT01717768|E11|Reported Event|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76107|NCT01717768|E10|Reported Event|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76108|NCT01717768|E9|Reported Event|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76109|NCT01717768|E8|Reported Event|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76110|NCT01717768|E7|Reported Event|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76111|NCT01717768|E6|Reported Event|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76112|NCT01717768|E5|Reported Event|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76239|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76113|NCT01717768|E4|Reported Event|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76114|NCT01717768|E3|Reported Event|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76115|NCT01717768|E2|Reported Event|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76116|NCT01717768|E1|Reported Event|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
76117|NCT01717638|B14|Baseline|Total|Total of all reporting groups
76118|NCT01717638|B13|Baseline|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76119|NCT01717638|B12|Baseline|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76120|NCT01717638|B11|Baseline|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76121|NCT01717638|B10|Baseline|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76122|NCT01717638|B9|Baseline|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76123|NCT01717638|B8|Baseline|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76124|NCT01717638|B7|Baseline|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76125|NCT01717638|B6|Baseline|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76126|NCT01717638|B5|Baseline|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76127|NCT01717638|B4|Baseline|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76128|NCT01717638|B3|Baseline|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76129|NCT01717638|B2|Baseline|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76130|NCT01717638|B1|Baseline|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76131|NCT01717638|P13|Participant Flow|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76132|NCT01717638|P12|Participant Flow|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76133|NCT01717638|P11|Participant Flow|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76134|NCT01717638|P10|Participant Flow|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76135|NCT01717638|P9|Participant Flow|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76136|NCT01717638|P8|Participant Flow|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76137|NCT01717638|P7|Participant Flow|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76138|NCT01717638|P6|Participant Flow|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76139|NCT01717638|P5|Participant Flow|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76140|NCT01717638|P4|Participant Flow|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76141|NCT01717638|P3|Participant Flow|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76142|NCT01717638|P2|Participant Flow|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76143|NCT01717638|P1|Participant Flow|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76144|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76145|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76146|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76147|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76148|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76149|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76150|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76151|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76152|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76153|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76154|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76155|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76156|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76157|NCT01717638|O2|Outcome|B48 50 (After 2nd Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76158|NCT01717638|O1|Outcome|B48 50 (After 1st Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76159|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76160|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76161|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76815|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76162|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76163|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76164|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76165|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76166|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76167|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76168|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76169|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76170|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76171|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76172|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76173|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76174|NCT01717638|O1|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76175|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76176|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76177|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76178|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76179|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76180|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76181|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76182|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76183|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76184|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76185|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76186|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76187|NCT01717638|O4|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76188|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76189|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
79117|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
76190|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76191|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76192|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76193|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76194|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76195|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76196|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76197|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76198|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76199|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76200|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76201|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76202|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76203|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76204|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76205|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76206|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76207|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76208|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76209|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76210|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76211|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76212|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76213|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76214|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76215|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76216|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76217|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76218|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76219|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76220|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76221|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76222|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76223|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76224|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76225|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76226|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76227|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76228|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76229|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76230|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76231|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76232|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76233|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76234|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76235|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76236|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76237|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76238|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76241|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76242|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76243|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76244|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76245|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76246|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76247|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76248|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76249|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76250|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76251|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76252|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76253|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76254|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76255|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76256|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76257|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76258|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76259|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76260|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76261|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76262|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76263|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76264|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76265|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76266|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76267|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76268|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76269|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76270|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76271|NCT01717638|E13|Reported Event|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
76272|NCT01717638|E12|Reported Event|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76273|NCT01717638|E11|Reported Event|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76274|NCT01717638|E10|Reported Event|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76275|NCT01717638|E9|Reported Event|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76276|NCT01717638|E8|Reported Event|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76277|NCT01717638|E7|Reported Event|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76278|NCT01717638|E6|Reported Event|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76279|NCT01717638|E5|Reported Event|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76280|NCT01717638|E4|Reported Event|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76281|NCT01717638|E3|Reported Event|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76282|NCT01717638|E2|Reported Event|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76283|NCT01717638|E1|Reported Event|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
76284|NCT01717456|B3|Baseline|Total|Total of all reporting groups
76285|NCT01717456|B2|Baseline|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76286|NCT01717456|B1|Baseline|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76287|NCT01717456|P2|Participant Flow|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76288|NCT01717456|P1|Participant Flow|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
76290|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76291|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76292|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76293|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76294|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76295|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76296|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76297|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76298|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76299|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76300|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76301|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76302|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76303|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76304|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76305|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76306|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76307|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76308|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76309|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76310|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76311|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76357|NCT01717326|B19|Baseline|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76312|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76313|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76314|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76315|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76316|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76317|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76318|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76319|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76320|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76321|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76322|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76323|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76324|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76325|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76326|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76327|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76328|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76329|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76330|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76331|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76332|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76333|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76358|NCT01717326|B18|Baseline|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
77092|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76334|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76335|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76336|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76337|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76338|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
76339|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76340|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
76341|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76342|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76343|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76344|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76345|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76346|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76347|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76348|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76349|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76350|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76351|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76352|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
76353|NCT01717456|E2|Reported Event|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
76354|NCT01717456|E1|Reported Event|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
76355|NCT01717326|B21|Baseline|Total|Total of all reporting groups
76356|NCT01717326|B20|Baseline|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
77093|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76359|NCT01717326|B17|Baseline|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76360|NCT01717326|B16|Baseline|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76361|NCT01717326|B15|Baseline|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76362|NCT01717326|B14|Baseline|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76363|NCT01717326|B13|Baseline|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76364|NCT01717326|B12|Baseline|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76365|NCT01717326|B11|Baseline|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76366|NCT01717326|B10|Baseline|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76367|NCT01717326|B9|Baseline|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76368|NCT01717326|B8|Baseline|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76369|NCT01717326|B7|Baseline|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76370|NCT01717326|B6|Baseline|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76371|NCT01717326|B5|Baseline|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76372|NCT01717326|B4|Baseline|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76373|NCT01717326|B3|Baseline|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76374|NCT01717326|B2|Baseline|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76375|NCT01717326|B1|Baseline|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76376|NCT01717326|P20|Participant Flow|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76377|NCT01717326|P19|Participant Flow|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76378|NCT01717326|P18|Participant Flow|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76379|NCT01717326|P17|Participant Flow|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76380|NCT01717326|P16|Participant Flow|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76381|NCT01717326|P15|Participant Flow|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76382|NCT01717326|P14|Participant Flow|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76383|NCT01717326|P13|Participant Flow|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
77094|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76384|NCT01717326|P12|Participant Flow|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76385|NCT01717326|P11|Participant Flow|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76386|NCT01717326|P10|Participant Flow|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76387|NCT01717326|P9|Participant Flow|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76388|NCT01717326|P8|Participant Flow|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76389|NCT01717326|P7|Participant Flow|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76390|NCT01717326|P6|Participant Flow|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76391|NCT01717326|P5|Participant Flow|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76392|NCT01717326|P4|Participant Flow|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76393|NCT01717326|P3|Participant Flow|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76394|NCT01717326|P2|Participant Flow|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76395|NCT01717326|P1|Participant Flow|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76396|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76397|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76398|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76399|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76400|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76401|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76402|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76403|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76404|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76405|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76406|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76407|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76408|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76719|NCT01717287|E1|Reported Event|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
76409|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76410|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76411|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76412|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76413|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76414|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76415|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76416|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76417|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76418|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76419|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76420|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76421|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76422|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76423|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76424|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76425|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76426|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76427|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76428|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76429|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76430|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76431|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76432|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76433|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76720|NCT01717040|B3|Baseline|Total|Total of all reporting groups
77095|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76434|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76435|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76436|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76437|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76438|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76439|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76440|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76441|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76442|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76443|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76444|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76445|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76446|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76447|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76448|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76449|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76450|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76451|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76452|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76453|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76454|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76455|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76456|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76457|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76458|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76459|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76460|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76461|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76462|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76463|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76464|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76465|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76466|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76467|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76468|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76469|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76470|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76471|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76472|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76473|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76474|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76475|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76476|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76477|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76478|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76479|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76480|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76481|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76482|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76483|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76484|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76485|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76486|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76487|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76488|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76489|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76490|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76491|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76492|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76493|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76494|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76495|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76496|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76497|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76498|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76499|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76500|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76501|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76502|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76503|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76504|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76505|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76506|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76507|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76508|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76509|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76510|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76511|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76512|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76513|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76514|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76515|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76516|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76517|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76518|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76519|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76520|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76521|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76522|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76523|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76524|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76525|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76526|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76527|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76528|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76529|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76530|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76531|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76532|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76533|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76534|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76535|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76536|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76537|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76538|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76539|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76540|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76541|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76542|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76543|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76544|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76545|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76546|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76547|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76548|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76549|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76550|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76551|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76552|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76553|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76554|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76555|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76556|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76557|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76558|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76559|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76560|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76721|NCT01717040|B2|Baseline|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76561|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76562|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76563|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76564|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76565|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76566|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76567|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76568|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76569|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76570|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76571|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76572|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76573|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76574|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76575|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76576|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76577|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76578|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76579|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76580|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76581|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76582|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76583|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76584|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76585|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76586|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76587|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76588|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76589|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76590|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76591|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76592|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76593|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76594|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76595|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76596|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76597|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76598|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76599|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76600|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76601|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76602|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76603|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76604|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76605|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76606|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76607|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76608|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76609|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76610|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76611|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76725|NCT01717040|O2|Outcome|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76612|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76613|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76614|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76615|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76616|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76617|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76618|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76619|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76620|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76621|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76622|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76623|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76624|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76625|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76626|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76627|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76628|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76629|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76630|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76631|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76632|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76633|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76634|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76635|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76636|NCT01717326|E20|Reported Event|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76637|NCT01717326|E19|Reported Event|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76638|NCT01717326|E18|Reported Event|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
76639|NCT01717326|E17|Reported Event|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76640|NCT01717326|E16|Reported Event|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76641|NCT01717326|E15|Reported Event|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76642|NCT01717326|E14|Reported Event|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76643|NCT01717326|E13|Reported Event|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76644|NCT01717326|E12|Reported Event|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76645|NCT01717326|E11|Reported Event|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76646|NCT01717326|E10|Reported Event|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
76647|NCT01717326|E9|Reported Event|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76648|NCT01717326|E8|Reported Event|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76649|NCT01717326|E7|Reported Event|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76650|NCT01717326|E6|Reported Event|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76651|NCT01717326|E5|Reported Event|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76652|NCT01717326|E4|Reported Event|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76653|NCT01717326|E3|Reported Event|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
76654|NCT01717326|E2|Reported Event|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76655|NCT01717326|E1|Reported Event|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
76656|NCT01717313|B3|Baseline|Total|Total of all reporting groups
76657|NCT01717313|B2|Baseline|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76658|NCT01717313|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76659|NCT01717313|P2|Participant Flow|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76722|NCT01717040|B1|Baseline|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76660|NCT01717313|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76661|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76662|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76663|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76664|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76665|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76666|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76667|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76668|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76669|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76670|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76671|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76672|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76673|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76674|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76723|NCT01717040|P2|Participant Flow|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76675|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76676|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76677|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76678|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76679|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76680|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76681|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76682|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76683|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76684|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76685|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76686|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76687|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76688|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76689|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76724|NCT01717040|P1|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76690|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76691|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76692|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76693|NCT01717313|E2|Reported Event|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76694|NCT01717313|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
76695|NCT01717287|B3|Baseline|Total|Total of all reporting groups
76696|NCT01717287|B2|Baseline|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76697|NCT01717287|B1|Baseline|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
76698|NCT01717287|P2|Participant Flow|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76699|NCT01717287|P1|Participant Flow|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
76700|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76701|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76702|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76703|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76704|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76705|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76706|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76707|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76708|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76709|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76710|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76711|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76712|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76713|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76714|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76715|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76716|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76717|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76718|NCT01717287|E2|Reported Event|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
76726|NCT01717040|O1|Outcome|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76727|NCT01717040|E2|Reported Event|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76728|NCT01717040|E1|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
76729|NCT01717014|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76730|NCT01717014|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76731|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76732|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76733|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76734|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76735|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76736|NCT01717014|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
76737|NCT01716663|B1|Baseline|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76738|NCT01716663|P1|Participant Flow|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76739|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76740|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76741|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76742|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76743|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76744|NCT01716663|E1|Reported Event|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
76745|NCT01716585|B3|Baseline|Total|Total of all reporting groups
76746|NCT01716585|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
76747|NCT01716585|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76748|NCT01716585|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76749|NCT01716585|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76750|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76814|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76751|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76752|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76753|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76754|NCT01716585|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
76755|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76756|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76757|NCT01716585|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76758|NCT01716585|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
76759|NCT01716585|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
76760|NCT01716559|B1|Baseline|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76761|NCT01716559|P1|Participant Flow|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76762|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76763|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76764|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76765|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76766|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76767|NCT01716559|E1|Reported Event|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
76768|NCT01716520|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
76769|NCT01716520|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
76770|NCT01716520|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
76771|NCT01716520|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
76772|NCT01716520|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
76773|NCT01716520|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
76774|NCT01716520|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
76775|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76776|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
79118|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
76777|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76778|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76779|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76780|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76781|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76782|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76783|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76784|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76785|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76786|NCT01716520|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76787|NCT01716520|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76788|NCT01716520|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
76789|NCT01716468|B1|Baseline|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
76790|NCT01716468|P1|Participant Flow|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
76791|NCT01716468|O1|Outcome|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
76792|NCT01716468|E1|Reported Event|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
76793|NCT01716455|B7|Baseline|Total|Total of all reporting groups
76794|NCT01716455|B6|Baseline|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76795|NCT01716455|B5|Baseline|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76796|NCT01716455|B4|Baseline|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76797|NCT01716455|B3|Baseline|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76798|NCT01716455|B2|Baseline|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76799|NCT01716455|B1|Baseline|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76800|NCT01716455|P6|Participant Flow|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76801|NCT01716455|P5|Participant Flow|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76802|NCT01716455|P4|Participant Flow|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76803|NCT01716455|P3|Participant Flow|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76804|NCT01716455|P2|Participant Flow|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76805|NCT01716455|P1|Participant Flow|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76806|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76807|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76808|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76809|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76810|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76811|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76812|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76813|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76816|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76817|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76818|NCT01716455|E3|Reported Event|Healthy Elderly Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76819|NCT01716455|E2|Reported Event|Matched Healthy Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76820|NCT01716455|E1|Reported Event|Impaired Renal Function|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
76821|NCT01716234|B8|Baseline|Total|Total of all reporting groups
76822|NCT01716234|B7|Baseline|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76823|NCT01716234|B6|Baseline|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76824|NCT01716234|B5|Baseline|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76825|NCT01716234|B4|Baseline|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76826|NCT01716234|B3|Baseline|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76827|NCT01716234|B2|Baseline|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76828|NCT01716234|B1|Baseline|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76829|NCT01716234|P7|Participant Flow|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76830|NCT01716234|P6|Participant Flow|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76831|NCT01716234|P5|Participant Flow|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76832|NCT01716234|P4|Participant Flow|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76833|NCT01716234|P3|Participant Flow|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76834|NCT01716234|P2|Participant Flow|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76835|NCT01716234|P1|Participant Flow|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76836|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76837|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76838|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76839|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76840|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76841|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76842|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76843|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76844|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76845|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76846|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76847|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76848|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76849|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
79119|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
76850|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76851|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76852|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76853|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76854|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76855|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76856|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76857|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76858|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76859|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76860|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76861|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76862|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76863|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76864|NCT01716234|E7|Reported Event|POS 12 TID 3 Months to <2 Yrs|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76865|NCT01716234|E6|Reported Event|POS 18 TID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76866|NCT01716234|E5|Reported Event|POS 18 TID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
76867|NCT01716234|E4|Reported Event|POS 18 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76868|NCT01716234|E3|Reported Event|POS 18 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76869|NCT01716234|E2|Reported Event|POS 12 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76870|NCT01716234|E1|Reported Event|POS 12 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
76871|NCT01716221|B1|Baseline|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
76872|NCT01716221|P1|Participant Flow|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
76873|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
76874|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
76875|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
76876|NCT01716221|O2|Outcome|Citalopram (Week 5)|
76877|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
76878|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
76879|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
76880|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
76881|NCT01716221|O2|Outcome|Citalopram (Week 5)|
76882|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
76883|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
76884|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
76885|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
76886|NCT01716221|O2|Outcome|Citalopram (Week 5)|
76887|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
76888|NCT01716221|O5|Outcome|Baseline|unblinded 100mg Bupropion & 20mg Citalopram
76889|NCT01716221|O4|Outcome|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
76890|NCT01716221|O3|Outcome|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
76891|NCT01716221|O2|Outcome|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
77096|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76892|NCT01716221|O1|Outcome|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
76893|NCT01716221|E4|Reported Event|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
76894|NCT01716221|E3|Reported Event|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
76895|NCT01716221|E2|Reported Event|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
76896|NCT01716221|E1|Reported Event|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
76897|NCT01716169|B1|Baseline|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
76898|NCT01716169|P1|Participant Flow|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
76899|NCT01716169|O2|Outcome|Standard of Care Dressing - Chronic Wound|Standard of Care dressings will be applied to one chronic wound
76900|NCT01716169|O1|Outcome|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
76901|NCT01716169|E2|Reported Event|Standard of Care - Chronic Wound|Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
76902|NCT01716169|E1|Reported Event|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
76903|NCT01716156|B4|Baseline|Total|Total of all reporting groups
76904|NCT01716156|B3|Baseline|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76905|NCT01716156|B2|Baseline|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76906|NCT01716156|B1|Baseline|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76907|NCT01716156|P3|Participant Flow|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76908|NCT01716156|P2|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76909|NCT01716156|P1|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76910|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76911|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76912|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76913|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76914|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76915|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76916|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76917|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76918|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76919|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76920|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76921|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76922|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV HCV GT1non-a|This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.
76923|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV HCV GT1a|This group consisted of all participants with HCV GT1a infection pooled across treatment arms.
76924|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
76925|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
76926|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
76927|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
76928|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
76929|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
76930|NCT01716156|E2|Reported Event|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
76931|NCT01716156|E1|Reported Event|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
76932|NCT01716052|B3|Baseline|Total|Total of all reporting groups
76933|NCT01716052|B2|Baseline|Placebo|"Lactulose~placebo: Lactulose"
76934|NCT01716052|B1|Baseline|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
76935|NCT01716052|P2|Participant Flow|Placebo|"Lactulose~placebo: Lactulose"
76936|NCT01716052|P1|Participant Flow|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
76937|NCT01716052|O2|Outcome|Placebo|"Lactulose~placebo: Lactulose"
76938|NCT01716052|O1|Outcome|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
76939|NCT01716052|E2|Reported Event|Placebo|"Lactulose~placebo: Lactulose"
76940|NCT01716052|E1|Reported Event|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
76941|NCT01716013|B3|Baseline|Total|Total of all reporting groups
76942|NCT01716013|B2|Baseline|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76943|NCT01716013|B1|Baseline|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76944|NCT01716013|P2|Participant Flow|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76945|NCT01716013|P1|Participant Flow|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76946|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76947|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76948|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76949|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76950|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76951|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76952|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76953|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
76954|NCT01716013|E2|Reported Event|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
76955|NCT01716013|E1|Reported Event|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
77097|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
76956|NCT01715948|B1|Baseline|A Comparison Between Wireless CROS and BAHD for SSD|"Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period."
76957|NCT01715948|P1|Participant Flow|Contralateral Routing of Signals (CROS) Hearing Aid|"Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries."
76958|NCT01715948|O6|Outcome|SSQ Subscale - Qualities (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
76959|NCT01715948|O5|Outcome|SSQ Subscale - Qualities (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
76960|NCT01715948|O4|Outcome|SSQ Subscale - Spatial (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
76961|NCT01715948|O3|Outcome|SSQ Subscale - Spatial (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
76962|NCT01715948|O2|Outcome|SSQ Subscale - Speech (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
76963|NCT01715948|O1|Outcome|SSQ Subscale - Speech (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
76964|NCT01715948|O3|Outcome|WRS in Quiet to Poorer Ear|Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
76965|NCT01715948|O2|Outcome|WRS Noise to Poorer Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
76966|NCT01715948|O1|Outcome|WRS Noise to Better Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
76967|NCT01715948|O6|Outcome|QuickSIN Noise to Poorer Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
76968|NCT01715948|O5|Outcome|QuickSIN Noise to Poorer Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
76969|NCT01715948|O4|Outcome|QuickSIN Noise to Poorer Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
76970|NCT01715948|O3|Outcome|QuickSIN Noise to Better Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
76971|NCT01715948|O2|Outcome|QuickSIN Noise to Better Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
76972|NCT01715948|O1|Outcome|QuickSIN Noise to Better Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
76973|NCT01715948|E2|Reported Event|CROS Aid|The intervention during which the CROS aid was trialed as part of the cross-over design
76974|NCT01715948|E1|Reported Event|BAHD|The intervention during which the BAHD was trialed as part of the cross-over design
76975|NCT01715896|B3|Baseline|Total|Total of all reporting groups
76976|NCT01715896|B2|Baseline|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76977|NCT01715896|B1|Baseline|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76978|NCT01715896|P2|Participant Flow|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76979|NCT01715896|P1|Participant Flow|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76980|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
79120|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
76981|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76982|NCT01715896|O1|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76983|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76984|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76985|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76986|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76987|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76988|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76989|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76990|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76991|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76992|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76993|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76994|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76995|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76996|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76997|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76998|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
76999|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77000|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77001|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77002|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77003|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77004|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77005|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77006|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77007|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77008|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77009|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77010|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77011|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77012|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77013|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77014|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77015|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77016|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77017|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77018|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77019|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77020|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77021|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77022|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77023|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77024|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77025|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77049|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77026|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77027|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77028|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77029|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77030|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77031|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77032|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77033|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77034|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77035|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77036|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77037|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77038|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77039|NCT01715896|E2|Reported Event|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77040|NCT01715896|E1|Reported Event|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
77041|NCT01715857|B1|Baseline|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77042|NCT01715857|P1|Participant Flow|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77043|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77044|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77045|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77046|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77047|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77048|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
79121|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
77050|NCT01715857|E1|Reported Event|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
77051|NCT01715415|B3|Baseline|Total|Total of all reporting groups
77052|NCT01715415|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
77053|NCT01715415|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77054|NCT01715415|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77055|NCT01715415|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77056|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77057|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77058|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77059|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77060|NCT01715415|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
77061|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77062|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77063|NCT01715415|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77064|NCT01715415|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
77065|NCT01715415|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
77066|NCT01715298|B3|Baseline|Total|Total of all reporting groups
77067|NCT01715298|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77068|NCT01715298|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77069|NCT01715298|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77070|NCT01715298|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77071|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77072|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77073|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77074|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77075|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77076|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77077|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77078|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77079|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77080|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77081|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77082|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77083|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77084|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77085|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77086|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77087|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77088|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77089|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77090|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77091|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77098|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77099|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77100|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77101|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77102|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77103|NCT01715298|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77104|NCT01715298|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
77105|NCT01715129|B1|Baseline|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77106|NCT01715129|P1|Participant Flow|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77107|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77108|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77109|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77110|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77111|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77112|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77113|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77114|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77115|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77116|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77117|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77118|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77119|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77120|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77121|NCT01715129|E1|Reported Event|Triptorelin Pamoate 11.25 mg|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
77122|NCT01715064|B3|Baseline|Total|Total of all reporting groups
77123|NCT01715064|B2|Baseline|Exercise|1 hour of moderate intensity exercise.
77124|NCT01715064|B1|Baseline|Control|non-exercise control consisting of movie watching.
77125|NCT01715064|P2|Participant Flow|Exercise (1hr of Mixed-modality Exercise)|1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
77126|NCT01715064|P1|Participant Flow|Control (1hr of Viewing Emotionally Neutral Movie)|non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
77127|NCT01715064|O2|Outcome|Exercise|1 hour of moderate intensity exercise.
77128|NCT01715064|O1|Outcome|Control|non-exercise control consisting of movie watching.
77129|NCT01715064|E2|Reported Event|Exercise|1 hour of moderate intensity exercise.
77130|NCT01715064|E1|Reported Event|Control|non-exercise control consisting of movie watching.
77131|NCT01714635|B4|Baseline|Total|Total of all reporting groups
77132|NCT01714635|B3|Baseline|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77133|NCT01714635|B2|Baseline|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77134|NCT01714635|B1|Baseline|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77135|NCT01714635|P3|Participant Flow|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77136|NCT01714635|P2|Participant Flow|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77137|NCT01714635|P1|Participant Flow|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77138|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77139|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77140|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77141|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77142|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77143|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77144|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77145|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77146|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77147|NCT01714635|E3|Reported Event|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
77148|NCT01714635|E2|Reported Event|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77149|NCT01714635|E1|Reported Event|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
77150|NCT01714609|B3|Baseline|Total|Total of all reporting groups
77151|NCT01714609|B2|Baseline|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
77152|NCT01714609|B1|Baseline|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
77153|NCT01714609|P2|Participant Flow|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
77154|NCT01714609|P1|Participant Flow|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
77155|NCT01714609|O2|Outcome|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
77156|NCT01714609|O1|Outcome|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
77157|NCT01714609|E2|Reported Event|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
77158|NCT01714609|E1|Reported Event|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
77159|NCT01714544|B1|Baseline|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
77160|NCT01714544|P1|Participant Flow|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
77161|NCT01714544|O1|Outcome|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
77162|NCT01714544|E1|Reported Event|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
77163|NCT01714505|B1|Baseline|Open and Closed Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
77164|NCT01714505|P2|Participant Flow|Closed-Loop Then Open-Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
77165|NCT01714505|P1|Participant Flow|Open-Loop Then Closed-Loop Control|"Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.~Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia."
77166|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
77167|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
77168|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
77169|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
77170|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
77171|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
77172|NCT01714505|E2|Reported Event|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
77173|NCT01714505|E1|Reported Event|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
77174|NCT01714492|B1|Baseline|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77175|NCT01714492|P1|Participant Flow|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77176|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77177|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77178|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77179|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77180|NCT01714492|O1|Outcome|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77181|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77182|NCT01714492|E1|Reported Event|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
77183|NCT01714336|B3|Baseline|Total|Total of all reporting groups
77184|NCT01714336|B2|Baseline|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77375|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
77185|NCT01714336|B1|Baseline|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77186|NCT01714336|P2|Participant Flow|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77187|NCT01714336|P1|Participant Flow|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77188|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77189|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77190|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77191|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77192|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77193|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77194|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77195|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77196|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77197|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77198|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77199|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77200|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77220|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77201|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77202|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77203|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77204|NCT01714336|E2|Reported Event|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
77205|NCT01714336|E1|Reported Event|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
77206|NCT01714232|B1|Baseline|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77207|NCT01714232|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77208|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77209|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77210|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77211|NCT01714232|E1|Reported Event|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
77212|NCT01713998|B4|Baseline|Total|Total of all reporting groups
77213|NCT01713998|B3|Baseline|Group C|Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.
77214|NCT01713998|B2|Baseline|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77215|NCT01713998|B1|Baseline|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77216|NCT01713998|P3|Participant Flow|Group C|Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
77217|NCT01713998|P2|Participant Flow|Group B|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.
77218|NCT01713998|P1|Participant Flow|Group A|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.
77219|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
77295|NCT01713608|E1|Reported Event|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77221|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77222|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
77223|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77224|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77225|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
77226|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77227|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77228|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.
77229|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77230|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77231|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
77232|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
77233|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
77234|NCT01713998|E1|Reported Event|Study Population|Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.
77235|NCT01713933|B1|Baseline|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77236|NCT01713933|P1|Participant Flow|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77237|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77238|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77239|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77240|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77241|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77242|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77243|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77244|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77245|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77246|NCT01713933|E1|Reported Event|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
77247|NCT01713686|B1|Baseline|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77248|NCT01713686|P1|Participant Flow|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77249|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77250|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77251|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77252|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77253|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77254|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77255|NCT01713686|E1|Reported Event|Ulthera System Treatment|"A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
77256|NCT01713660|B1|Baseline|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77257|NCT01713660|P1|Participant Flow|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77258|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77259|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77260|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77261|NCT01713660|E1|Reported Event|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
77262|NCT01713621|B3|Baseline|Total|Total of all reporting groups
77263|NCT01713621|B2|Baseline|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
77264|NCT01713621|B1|Baseline|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
77265|NCT01713621|P2|Participant Flow|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
77266|NCT01713621|P1|Participant Flow|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
77267|NCT01713621|O2|Outcome|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
77268|NCT01713621|O1|Outcome|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
77269|NCT01713621|E2|Reported Event|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
77270|NCT01713621|E1|Reported Event|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
77271|NCT01713608|B5|Baseline|Total|Total of all reporting groups
77272|NCT01713608|B4|Baseline|Placebo|Placebo to match OZ439 PIB for oral suspension
77273|NCT01713608|B3|Baseline|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77274|NCT01713608|B2|Baseline|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77275|NCT01713608|B1|Baseline|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77276|NCT01713608|P4|Participant Flow|Placebo|Placebo to match OZ439 PIB for oral suspension
77277|NCT01713608|P3|Participant Flow|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77278|NCT01713608|P2|Participant Flow|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77279|NCT01713608|P1|Participant Flow|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77280|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77281|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77282|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77283|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77284|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77285|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77286|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77287|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77288|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77289|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77290|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77291|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
77292|NCT01713608|E4|Reported Event|Placebo|Placebo to match OZ439 PIB for oral suspension
77293|NCT01713608|E3|Reported Event|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
77294|NCT01713608|E2|Reported Event|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
77296|NCT01713530|B3|Baseline|Total|Total of all reporting groups
77297|NCT01713530|B2|Baseline|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77298|NCT01713530|B1|Baseline|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77299|NCT01713530|P2|Participant Flow|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77300|NCT01713530|P1|Participant Flow|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77301|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77302|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77303|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77304|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77305|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77306|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77307|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77344|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77308|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77309|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77310|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77311|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77312|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77313|NCT01713530|E2|Reported Event|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
77314|NCT01713530|E1|Reported Event|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
77315|NCT01713400|B3|Baseline|Total|Total of all reporting groups
77316|NCT01713400|B2|Baseline|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77317|NCT01713400|B1|Baseline|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77318|NCT01713400|P2|Participant Flow|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77319|NCT01713400|P1|Participant Flow|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77320|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77321|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77322|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77742|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77323|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77324|NCT01713400|E2|Reported Event|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77325|NCT01713400|E1|Reported Event|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
77326|NCT01713348|B5|Baseline|Total|Total of all reporting groups
77327|NCT01713348|B4|Baseline|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77328|NCT01713348|B3|Baseline|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77329|NCT01713348|B2|Baseline|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77330|NCT01713348|B1|Baseline|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77331|NCT01713348|P4|Participant Flow|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77332|NCT01713348|P3|Participant Flow|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77333|NCT01713348|P2|Participant Flow|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77334|NCT01713348|P1|Participant Flow|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77335|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77336|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77337|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77338|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77339|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77340|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77341|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77342|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77343|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77374|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
77345|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77346|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77347|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77348|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77349|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77350|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77351|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77352|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77353|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
77354|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77355|NCT01713348|E4|Reported Event|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
77356|NCT01713348|E3|Reported Event|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77357|NCT01713348|E2|Reported Event|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
77358|NCT01713348|E1|Reported Event|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
77359|NCT01713283|B5|Baseline|Total|Total of all reporting groups
77360|NCT01713283|B4|Baseline|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
77361|NCT01713283|B3|Baseline|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
77362|NCT01713283|B2|Baseline|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
77363|NCT01713283|B1|Baseline|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
77364|NCT01713283|P2|Participant Flow|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
77365|NCT01713283|P1|Participant Flow|SOF+RBV 12 Wk|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
77366|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
77367|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
77368|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
77369|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
77370|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
77371|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
77372|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
77373|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
77376|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
77377|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
77378|NCT01713283|O2|Outcome|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
77379|NCT01713283|O1|Outcome|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
77380|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
77381|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
77382|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
77383|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
77384|NCT01713283|E2|Reported Event|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
77385|NCT01713283|E1|Reported Event|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
77386|NCT01713036|B1|Baseline|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
77387|NCT01713036|P1|Participant Flow|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
77388|NCT01713036|O1|Outcome|Pimasertib|Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [μCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
77389|NCT01713036|O1|Outcome|Pimasertib|Part B : Subjects received 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
77390|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77391|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77392|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77393|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77394|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77395|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77396|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77397|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77398|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77399|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77400|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77401|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77464|NCT01712711|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
77402|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77403|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77404|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77405|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77406|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77407|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77408|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77409|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77410|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77411|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77412|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77413|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77414|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77415|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
77416|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of mass balance, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
77417|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77418|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77419|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77420|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77421|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
77422|NCT01713036|E1|Reported Event|Pimasertib|"Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the IV tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 μCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally.~Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death."
77423|NCT01712984|B4|Baseline|Total|Total of all reporting groups
77424|NCT01712984|B3|Baseline|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77425|NCT01712984|B2|Baseline|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77426|NCT01712984|B1|Baseline|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77427|NCT01712984|P3|Participant Flow|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77807|NCT01710514|B2|Baseline|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77428|NCT01712984|P2|Participant Flow|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77429|NCT01712984|P1|Participant Flow|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77430|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77431|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77432|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77433|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77434|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77435|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77436|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77437|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77438|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77439|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77440|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77441|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77442|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77443|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77444|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77445|NCT01712984|E3|Reported Event|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
77446|NCT01712984|E2|Reported Event|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
77447|NCT01712984|E1|Reported Event|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
77448|NCT01712854|B1|Baseline|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
77449|NCT01712854|P1|Participant Flow|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
77450|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
77451|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
77452|NCT01712854|E1|Reported Event|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
77453|NCT01712776|B3|Baseline|Total|Total of all reporting groups
77454|NCT01712776|B2|Baseline|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
77455|NCT01712776|B1|Baseline|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
77456|NCT01712776|P2|Participant Flow|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
77457|NCT01712776|P1|Participant Flow|Placebo (Normal Saline, Nature&Apos;s Tears)|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
77458|NCT01712776|O2|Outcome|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
77459|NCT01712776|O1|Outcome|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
77460|NCT01712776|E2|Reported Event|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
77461|NCT01712776|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
77462|NCT01712711|B3|Baseline|Total|Total of all reporting groups
77463|NCT01712711|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
77465|NCT01712711|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
77466|NCT01712711|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
77467|NCT01712711|O2|Outcome|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
77468|NCT01712711|O1|Outcome|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
77469|NCT01712711|E2|Reported Event|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
77470|NCT01712711|E1|Reported Event|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
77471|NCT01712685|B1|Baseline|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77472|NCT01712685|P1|Participant Flow|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77473|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77474|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77475|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77476|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77477|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77478|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77479|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77480|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77481|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77552|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77482|NCT01712685|E1|Reported Event|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
77483|NCT01712516|B5|Baseline|Total|Total of all reporting groups
77484|NCT01712516|B4|Baseline|Placebo|b.i.d.
77485|NCT01712516|B3|Baseline|NVA237|12.5 ug b.i.d.
77486|NCT01712516|B2|Baseline|QAB149|27.5 ug b.i.d.
77487|NCT01712516|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77488|NCT01712516|P4|Participant Flow|Placebo|b.i.d.
77489|NCT01712516|P3|Participant Flow|NVA237|12.5 ug b.i.d.
77490|NCT01712516|P2|Participant Flow|QAB149|27.5 ug b.i.d.
77491|NCT01712516|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77492|NCT01712516|O4|Outcome|Placebo|b.i.d.
77493|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77494|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77495|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77496|NCT01712516|O4|Outcome|Placebo|b.i.d.
77497|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77498|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77499|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77500|NCT01712516|O4|Outcome|Placebo|b.i.d.
77501|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77502|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77503|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77504|NCT01712516|O4|Outcome|Placebo|b.i.d.
77505|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77506|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77507|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77508|NCT01712516|O4|Outcome|Placebo|b.i.d.
77509|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77510|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77511|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77512|NCT01712516|O4|Outcome|Placebo|b.i.d.
77513|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77514|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77515|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77516|NCT01712516|O4|Outcome|Placebo|b.i.d.
77517|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77518|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77519|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77520|NCT01712516|O4|Outcome|Placebo|b.i.d.
77521|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77522|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77523|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77524|NCT01712516|O4|Outcome|Placebo|b.i.d.
77525|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77526|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77527|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77528|NCT01712516|O4|Outcome|Placebo|b.i.d.
77529|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77530|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77531|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77532|NCT01712516|O4|Outcome|Placebo|b.i.d.
77533|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
77534|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
77535|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77536|NCT01712516|E4|Reported Event|Placebo|b.i.d.
77537|NCT01712516|E3|Reported Event|NVA237|12.5 ug b.i.d.
77538|NCT01712516|E2|Reported Event|QAB149|27.5 ug b.i.d.
77539|NCT01712516|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
77540|NCT01712360|B5|Baseline|Total|Total of all reporting groups
77541|NCT01712360|B4|Baseline|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77542|NCT01712360|B3|Baseline|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77543|NCT01712360|B2|Baseline|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77544|NCT01712360|B1|Baseline|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77545|NCT01712360|P4|Participant Flow|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77546|NCT01712360|P3|Participant Flow|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77547|NCT01712360|P2|Participant Flow|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77548|NCT01712360|P1|Participant Flow|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77549|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77550|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77551|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77553|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77554|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77555|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77556|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77557|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77558|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77559|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77560|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77561|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77562|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77563|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77564|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77565|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77566|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77567|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77568|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77569|NCT01712360|E4|Reported Event|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
77570|NCT01712360|E3|Reported Event|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
77571|NCT01712360|E2|Reported Event|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
77572|NCT01712360|E1|Reported Event|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
77573|NCT01712334|B1|Baseline|All Participants|All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.
77574|NCT01712334|P2|Participant Flow|Jet Nebulizer Then eRapid Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.
77575|NCT01712334|P1|Participant Flow|eRapid Nebulizer Then Jet Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.
77576|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
77577|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
77578|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
77579|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
77580|NCT01712334|E2|Reported Event|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
77581|NCT01712334|E1|Reported Event|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
77582|NCT01712204|B3|Baseline|Total|Total of all reporting groups
77583|NCT01712204|B2|Baseline|AC-201 50mg Capsule BID|AC-201 50mg Capsule BID for 16 Weeks
77584|NCT01712204|B1|Baseline|Placebo Capsule BID|Placebo Capsule BID for 16 Weeks
77585|NCT01712204|P2|Participant Flow|AC-201|AC-201 50mg Capsule BID for 16 Weeks
77586|NCT01712204|P1|Participant Flow|Placebo|Placebo Capsule BID for 16 Weeks
77587|NCT01712204|O2|Outcome|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
77588|NCT01712204|O1|Outcome|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
77589|NCT01712204|E2|Reported Event|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
77590|NCT01712204|E1|Reported Event|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
77591|NCT01712178|B3|Baseline|Total|Total of all reporting groups
77592|NCT01712178|B2|Baseline|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77593|NCT01712178|B1|Baseline|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77594|NCT01712178|P2|Participant Flow|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77595|NCT01712178|P1|Participant Flow|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77596|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77597|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77598|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77599|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77600|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77601|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77602|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77603|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77604|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77605|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77606|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77607|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77608|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77609|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77610|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77611|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77612|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
77613|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
77614|NCT01712178|E2|Reported Event|Current Formulation Adalimumab 40 mg Every Other Week|
77615|NCT01712178|E1|Reported Event|New Formulation of Adalimumab 40 mg Every Other Week|
77616|NCT01712061|B3|Baseline|Total|Total of all reporting groups
77617|NCT01712061|B2|Baseline|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77618|NCT01712061|B1|Baseline|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77619|NCT01712061|P3|Participant Flow|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77620|NCT01712061|P2|Participant Flow|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
77621|NCT01712061|P1|Participant Flow|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
77622|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77623|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77624|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77625|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77626|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77627|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77628|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77629|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77630|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77631|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77632|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77633|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77634|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77635|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77636|NCT01712061|O2|Outcome|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
77637|NCT01712061|O1|Outcome|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
77638|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77639|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77640|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77641|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77642|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77643|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77644|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77645|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77646|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77647|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77648|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77649|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77650|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77651|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77652|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77653|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
77654|NCT01712061|E3|Reported Event|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
77655|NCT01712061|E2|Reported Event|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
77656|NCT01712061|E1|Reported Event|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
77657|NCT01712009|B4|Baseline|Total|Total of all reporting groups
77658|NCT01712009|B3|Baseline|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77659|NCT01712009|B2|Baseline|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77660|NCT01712009|B1|Baseline|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77661|NCT01712009|P3|Participant Flow|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77662|NCT01712009|P2|Participant Flow|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77663|NCT01712009|P1|Participant Flow|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77664|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77665|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77666|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77667|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77668|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77669|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77670|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77671|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77672|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77673|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77674|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77675|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77676|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77677|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77678|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77679|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77680|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77681|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77682|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77683|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77684|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77685|NCT01712009|E3|Reported Event|Loratadine 10mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77686|NCT01712009|E2|Reported Event|Naproxen 500mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
77687|NCT01712009|E1|Reported Event|No Prophylactic Intervention|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
77688|NCT01711918|B1|Baseline|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77689|NCT01711918|P1|Participant Flow|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77690|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77691|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77692|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77693|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77694|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77695|NCT01711918|E1|Reported Event|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
77696|NCT01711866|B1|Baseline|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
77697|NCT01711866|P1|Participant Flow|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
77698|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
77739|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77740|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77699|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
77700|NCT01711866|E1|Reported Event|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
77701|NCT01711853|B1|Baseline|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
77702|NCT01711853|P1|Participant Flow|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
77703|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
77704|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
77705|NCT01711853|E1|Reported Event|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
77706|NCT01711736|B3|Baseline|Total|Total of all reporting groups
77707|NCT01711736|B2|Baseline|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77708|NCT01711736|B1|Baseline|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77709|NCT01711736|P2|Participant Flow|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77710|NCT01711736|P1|Participant Flow|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77711|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77712|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77713|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77714|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77715|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77716|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77717|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77718|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77741|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77808|NCT01710514|B1|Baseline|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77719|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77720|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77721|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77722|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77723|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77724|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77725|NCT01711736|O1|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77726|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77727|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77728|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77729|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77730|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77731|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77732|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77733|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77734|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77735|NCT01711736|E2|Reported Event|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77736|NCT01711736|E1|Reported Event|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
77737|NCT01711424|B1|Baseline|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77738|NCT01711424|P1|Participant Flow|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77743|NCT01711424|E1|Reported Event|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
77744|NCT01711216|B1|Baseline|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77745|NCT01711216|P1|Participant Flow|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77746|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77747|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77748|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77749|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77750|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77751|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77752|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77753|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77754|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77755|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77756|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77757|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77758|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77759|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77760|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77761|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77762|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77763|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77764|NCT01711216|E1|Reported Event|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
77765|NCT01711177|B4|Baseline|Total|Total of all reporting groups
77766|NCT01711177|B3|Baseline|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
77767|NCT01711177|B2|Baseline|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
77768|NCT01711177|B1|Baseline|Normal Control|"Normal patient placebo~placebo: Placebo"
77769|NCT01711177|P3|Participant Flow|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
77770|NCT01711177|P2|Participant Flow|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
77771|NCT01711177|P1|Participant Flow|Normal Control|"Normal patient placebo~placebo: Placebo"
77772|NCT01711177|O3|Outcome|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
77773|NCT01711177|O2|Outcome|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
77774|NCT01711177|O1|Outcome|Normal Control|"Normal patient placebo~placebo: Placebo"
77775|NCT01711177|E3|Reported Event|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
77776|NCT01711177|E2|Reported Event|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
77777|NCT01711177|E1|Reported Event|Normal Control|"Normal patient placebo~placebo: Placebo"
77778|NCT01710800|B1|Baseline|All Study Participants|Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
77779|NCT01710800|P1|Participant Flow|First Intervention (7 Days), Second Intervention (7 Days)|Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
77780|NCT01710800|O2|Outcome|Esomeprazole|Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
77781|NCT01710800|O1|Outcome|Placebo Arm|Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
77782|NCT01710800|E2|Reported Event|PPI Arm|
77783|NCT01710800|E1|Reported Event|Placebo Arm|
77784|NCT01710657|B4|Baseline|Total|Total of all reporting groups
77785|NCT01710657|B3|Baseline|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77786|NCT01710657|B2|Baseline|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77787|NCT01710657|B1|Baseline|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77788|NCT01710657|P3|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77789|NCT01710657|P2|Participant Flow|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77790|NCT01710657|P1|Participant Flow|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77791|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77792|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77793|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77794|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77795|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77796|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77797|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77798|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77799|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77800|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77801|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77802|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77803|NCT01710657|E3|Reported Event|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77804|NCT01710657|E2|Reported Event|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
77805|NCT01710657|E1|Reported Event|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
77806|NCT01710514|B3|Baseline|Total|Total of all reporting groups
77809|NCT01710514|P2|Participant Flow|FE 999913 100 mg TID|"FE 999913 100 mg vaginal tablet TID~FE 999913 vaginal tablet"
77810|NCT01710514|P1|Participant Flow|FE 999913 100 mg BID|"FE 999913 100 mg vaginal tablet BID~FE 999913 vaginal tablet"
77811|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
77812|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77813|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77814|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
77815|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77816|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77817|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
77818|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77819|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77820|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
77821|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77822|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77823|NCT01710514|O1|Outcome|FE999913 000072 (BID/TID)|Data pooled from both BID and TID groups
77824|NCT01710514|E3|Reported Event|FE 999913 Total|Data pooled from BID and TID groups
77825|NCT01710514|E2|Reported Event|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
77826|NCT01710514|E1|Reported Event|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
77827|NCT01710501|B4|Baseline|Total|Total of all reporting groups
77828|NCT01710501|B3|Baseline|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77829|NCT01710501|B2|Baseline|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77830|NCT01710501|B1|Baseline|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77831|NCT01710501|P3|Participant Flow|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77832|NCT01710501|P2|Participant Flow|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77833|NCT01710501|P1|Participant Flow|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77834|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77835|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77836|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77837|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77838|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77839|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77840|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77841|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
79122|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
77842|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77843|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77844|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77845|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77846|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77847|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77848|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77849|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77850|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77851|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77852|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77853|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77854|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77855|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77856|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77857|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77858|NCT01710501|E3|Reported Event|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77859|NCT01710501|E2|Reported Event|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77860|NCT01710501|E1|Reported Event|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
77861|NCT01710345|B4|Baseline|Total|Total of all reporting groups
77862|NCT01710345|B3|Baseline|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
77863|NCT01710345|B2|Baseline|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
77864|NCT01710345|B1|Baseline|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
77865|NCT01710345|P3|Participant Flow|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
77866|NCT01710345|P2|Participant Flow|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
77867|NCT01710345|P1|Participant Flow|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
77868|NCT01710345|O3|Outcome|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
77869|NCT01710345|O2|Outcome|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
77870|NCT01710345|O1|Outcome|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
77871|NCT01710345|E3|Reported Event|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
77872|NCT01710345|E2|Reported Event|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
77873|NCT01710345|E1|Reported Event|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
77874|NCT01710046|B3|Baseline|Total|Total of all reporting groups
77875|NCT01710046|B2|Baseline|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77876|NCT01710046|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77877|NCT01710046|P2|Participant Flow|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77878|NCT01710046|P1|Participant Flow|Tofacitinib 10 Milligrams (mg) Twice Daily (BID)|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77879|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77880|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77881|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77882|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77883|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77884|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77885|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77886|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77887|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77888|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77889|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77890|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77891|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77892|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77893|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77894|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77895|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77896|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77897|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77898|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77899|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77900|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77901|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77902|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77903|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77904|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77905|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77906|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77907|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77908|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77909|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77910|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77911|NCT01710046|E2|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
77912|NCT01710046|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
77913|NCT01710033|B5|Baseline|Total|Total of all reporting groups
77914|NCT01710033|B4|Baseline|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
78007|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
79123|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
77915|NCT01710033|B3|Baseline|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77916|NCT01710033|B2|Baseline|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77917|NCT01710033|B1|Baseline|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77918|NCT01710033|P5|Participant Flow|CP-690,550 30 mg, Stage 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.
77919|NCT01710033|P4|Participant Flow|CP-690,550 30 mg, Stage 1|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.
77920|NCT01710033|P3|Participant Flow|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77921|NCT01710033|P2|Participant Flow|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77922|NCT01710033|P1|Participant Flow|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.
77923|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77924|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77925|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77926|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77927|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77928|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77929|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77930|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77931|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77932|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77933|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77934|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77935|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77936|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
79124|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
77937|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77938|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77939|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77940|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77941|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77942|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77943|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77944|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77945|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77946|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77947|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77948|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77949|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77950|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77951|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77952|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77953|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77954|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77955|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77956|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77957|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77958|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
78008|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
79125|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
77959|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77960|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77961|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77962|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77963|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77964|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77965|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77966|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77967|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77968|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77969|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77970|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77971|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77972|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77973|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77974|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77975|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77976|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77977|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77978|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77979|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77980|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77981|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77982|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77983|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77984|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77985|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77986|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77987|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77988|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77989|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77990|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77991|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77992|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77993|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77994|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77995|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77996|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
77997|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
77998|NCT01710033|E4|Reported Event|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
77999|NCT01710033|E3|Reported Event|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
78000|NCT01710033|E2|Reported Event|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
78001|NCT01710033|E1|Reported Event|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
78002|NCT01710020|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
78003|NCT01710020|P1|Participant Flow|CP-690,550 (10 mg OPC)|Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.
78004|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
78005|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
78006|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78009|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
78010|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
78011|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78012|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78013|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78014|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78015|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78016|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78017|NCT01710020|E2|Reported Event|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
78018|NCT01710020|E1|Reported Event|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
78019|NCT01709903|B3|Baseline|Total|Total of all reporting groups
78020|NCT01709903|B2|Baseline|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78021|NCT01709903|B1|Baseline|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78022|NCT01709903|P2|Participant Flow|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78023|NCT01709903|P1|Participant Flow|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78024|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78025|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78026|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78027|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78028|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78029|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78030|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78031|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78032|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78033|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78034|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78035|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78036|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78037|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78038|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78039|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78040|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78041|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78042|NCT01709903|E2|Reported Event|Salmeterol/Fluticasone 50mcg/500mcg|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
78043|NCT01709903|E1|Reported Event|QVA149 110mcg/50mcg|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
78044|NCT01709864|B3|Baseline|Total|Total of all reporting groups
78045|NCT01709864|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78046|NCT01709864|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78047|NCT01709864|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78048|NCT01709864|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78049|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78050|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78051|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78052|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78053|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78054|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78055|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78056|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78057|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78058|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78059|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78060|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78061|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78062|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78063|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78064|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78065|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78066|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78067|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78068|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78069|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78070|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78071|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78072|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78073|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78074|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78075|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78076|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78077|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78078|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78079|NCT01709864|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
78080|NCT01709864|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
78081|NCT01709799|B4|Baseline|Total|Total of all reporting groups
78082|NCT01709799|B3|Baseline|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78083|NCT01709799|B2|Baseline|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
78084|NCT01709799|B1|Baseline|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
78085|NCT01709799|P3|Participant Flow|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78124|NCT01709708|E1|Reported Event|Marcaine|"Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
78125|NCT01709513|B4|Baseline|Total|Total of all reporting groups
78214|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78596|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78086|NCT01709799|P2|Participant Flow|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
78087|NCT01709799|P1|Participant Flow|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
78088|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78089|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78090|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78091|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78092|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78093|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78094|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78126|NCT01709513|B3|Baseline|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78354|NCT01708967|B3|Baseline|Total|Total of all reporting groups
78095|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78096|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78097|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78098|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78099|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78100|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78101|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78102|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78103|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78127|NCT01709513|B2|Baseline|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78128|NCT01709513|B1|Baseline|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable lipid-modifying therapy (LMT).
78104|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78105|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
78106|NCT01709799|E3|Reported Event|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
78107|NCT01709799|E2|Reported Event|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
78108|NCT01709799|E1|Reported Event|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
78109|NCT01709786|B1|Baseline|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
78110|NCT01709786|P1|Participant Flow|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
78111|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
78112|NCT01709786|O1|Outcome|iSTAT Hemoglobin|iSTAT hemoglobin measurement
78113|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
78114|NCT01709786|O1|Outcome|Radical-7 Hemoglobin|Radical-7 hemoglobin measurement
78115|NCT01709786|E1|Reported Event|Radical-7 vs. CBC|All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
78116|NCT01709708|B3|Baseline|Total|Total of all reporting groups
78117|NCT01709708|B2|Baseline|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
78118|NCT01709708|B1|Baseline|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
78119|NCT01709708|P2|Participant Flow|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
78120|NCT01709708|P1|Participant Flow|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
78121|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
78122|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
78123|NCT01709708|E2|Reported Event|Saline|Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
78597|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78129|NCT01709513|P3|Participant Flow|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78130|NCT01709513|P2|Participant Flow|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78131|NCT01709513|P1|Participant Flow|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable LMT.
78132|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78133|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78134|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78135|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78136|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78137|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78138|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78139|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78140|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78141|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78142|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78143|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78144|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78145|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78146|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78147|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78148|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78149|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78150|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78151|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78152|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78153|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78179|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78154|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78155|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78156|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78157|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78158|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78159|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78160|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78161|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78162|NCT01709513|O2|Outcome|Alirocumab 75/ up to 150|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78163|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78164|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78165|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78166|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78167|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78168|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78169|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78170|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78171|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78172|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78173|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78174|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78175|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78176|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78177|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78178|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78180|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78181|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78182|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78183|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78184|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78185|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
78186|NCT01709513|E3|Reported Event|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 22 weeks and placebo for atorvastatin/ezetimibe over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-­C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
78187|NCT01709513|E2|Reported Event|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo for alirocumab SC injection Q2W for 22 weeks added to stable LMT.
78188|NCT01709513|E1|Reported Event|Atorvastatin|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 22 weeks added to stable LMT.
78189|NCT01709500|B3|Baseline|Total|Total of all reporting groups
78190|NCT01709500|B2|Baseline|Placebo|Placebo matched to alirocumab SC injection for 78­-week treatment duration.
78191|NCT01709500|B1|Baseline|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78192|NCT01709500|P2|Participant Flow|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78193|NCT01709500|P1|Participant Flow|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78194|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78195|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78196|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78197|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78198|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78199|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78200|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78201|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78202|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78203|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78204|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78205|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78206|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78207|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78208|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78209|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78210|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78211|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78212|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78213|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78215|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78216|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78217|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78218|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78219|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78220|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78221|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78222|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78223|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78224|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78225|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78226|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78227|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78228|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78229|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78230|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78231|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78232|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78233|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78234|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78235|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78236|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78237|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78238|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78239|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78240|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78241|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78242|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78243|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78244|NCT01709500|E2|Reported Event|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
78245|NCT01709500|E1|Reported Event|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
78246|NCT01709474|B3|Baseline|Total|Total of all reporting groups
78247|NCT01709474|B2|Baseline|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
78248|NCT01709474|B1|Baseline|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
78249|NCT01709474|P2|Participant Flow|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
78250|NCT01709474|P1|Participant Flow|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
78251|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
78252|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
78253|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
78254|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
78255|NCT01709474|E2|Reported Event|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
78256|NCT01709474|E1|Reported Event|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
78257|NCT01709422|B3|Baseline|Total|Total of all reporting groups
78258|NCT01709422|B2|Baseline|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
78259|NCT01709422|B1|Baseline|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
78260|NCT01709422|P2|Participant Flow|Conventional|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
78261|NCT01709422|P1|Participant Flow|Propofol|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
78262|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.
78263|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit
78264|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
78265|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
78266|NCT01709422|E2|Reported Event|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
78267|NCT01709422|E1|Reported Event|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
78268|NCT01709331|B1|Baseline|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78269|NCT01709331|P1|Participant Flow|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78270|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78271|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78272|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78273|NCT01709331|E1|Reported Event|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
78274|NCT01709305|B1|Baseline|Overall Study|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
78355|NCT01708967|B2|Baseline|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter"
78275|NCT01709305|P5|Participant Flow|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
78276|NCT01709305|P4|Participant Flow|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
78277|NCT01709305|P3|Participant Flow|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
78278|NCT01709305|P2|Participant Flow|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
78279|NCT01709305|P1|Participant Flow|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
78280|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78281|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78282|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78283|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78284|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78285|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78286|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78287|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78288|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78289|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78290|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78291|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78292|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78293|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78294|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78295|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78296|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78297|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78298|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78299|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78300|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.
78301|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.
78356|NCT01708967|B1|Baseline|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)"
78302|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
78303|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
78304|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78305|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78306|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78307|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78308|NCT01709305|E5|Reported Event|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78309|NCT01709305|E4|Reported Event|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78310|NCT01709305|E3|Reported Event|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78311|NCT01709305|E2|Reported Event|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
78312|NCT01709305|E1|Reported Event|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
78313|NCT01709162|B3|Baseline|Total|Total of all reporting groups
78314|NCT01709162|B2|Baseline|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78315|NCT01709162|B1|Baseline|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78316|NCT01709162|P2|Participant Flow|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78317|NCT01709162|P1|Participant Flow|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78318|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78319|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78320|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78321|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78322|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78323|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78324|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78325|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78326|NCT01709162|E2|Reported Event|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
78327|NCT01709162|E1|Reported Event|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
78328|NCT01709136|B1|Baseline|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
78329|NCT01709136|P1|Participant Flow|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate Glomerular Filtration Rate (GFR) evaluation, or a few days later at the convenience of the subject.
78375|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78598|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78330|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
78331|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
78332|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab..
78333|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
78334|NCT01709136|E1|Reported Event|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
78335|NCT01709084|B3|Baseline|Total|Total of all reporting groups
78336|NCT01709084|B2|Baseline|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78337|NCT01709084|B1|Baseline|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78338|NCT01709084|P2|Participant Flow|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78339|NCT01709084|P1|Participant Flow|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78340|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78341|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78342|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78343|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78344|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78345|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78346|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78347|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78348|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78349|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78350|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78351|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78352|NCT01709084|E2|Reported Event|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
78353|NCT01709084|E1|Reported Event|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
78357|NCT01708967|P2|Participant Flow|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78358|NCT01708967|P1|Participant Flow|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78359|NCT01708967|O2|Outcome|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78360|NCT01708967|O1|Outcome|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78361|NCT01708967|E2|Reported Event|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78362|NCT01708967|E1|Reported Event|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
78363|NCT01708954|B4|Baseline|Total|Total of all reporting groups
78364|NCT01708954|B3|Baseline|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78365|NCT01708954|B2|Baseline|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78366|NCT01708954|B1|Baseline|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78367|NCT01708954|P3|Participant Flow|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78368|NCT01708954|P2|Participant Flow|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78369|NCT01708954|P1|Participant Flow|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78370|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78371|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78372|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78373|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78374|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78460|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78376|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78377|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78378|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78379|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78380|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78381|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78382|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78383|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78384|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78385|NCT01708954|E4|Reported Event|Arm Z (Erlotinib+Cabozantinib; Step 2)|Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78386|NCT01708954|E3|Reported Event|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78387|NCT01708954|E2|Reported Event|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78388|NCT01708954|E1|Reported Event|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
78389|NCT01708915|B5|Baseline|Total|Total of all reporting groups
78390|NCT01708915|B4|Baseline|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78391|NCT01708915|B3|Baseline|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78392|NCT01708915|B2|Baseline|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78393|NCT01708915|B1|Baseline|Placebo|Patients treated with placebo ointment
78394|NCT01708915|P4|Participant Flow|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78395|NCT01708915|P3|Participant Flow|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78396|NCT01708915|P2|Participant Flow|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78397|NCT01708915|P1|Participant Flow|Placebo|Patients treated with placebo ointment
78398|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78399|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78400|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78401|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
78402|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78403|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78404|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78405|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
78406|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78407|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78408|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78409|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
78410|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
78411|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78412|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78413|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
78414|NCT01708915|E4|Reported Event|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
78415|NCT01708915|E3|Reported Event|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
78416|NCT01708915|E2|Reported Event|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
78417|NCT01708915|E1|Reported Event|Placebo|Patients treated with placebo ointment
78418|NCT01708902|B8|Baseline|Total|Total of all reporting groups
78419|NCT01708902|B7|Baseline|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78420|NCT01708902|B6|Baseline|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78421|NCT01708902|B5|Baseline|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78422|NCT01708902|B4|Baseline|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78423|NCT01708902|B3|Baseline|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78424|NCT01708902|B2|Baseline|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78425|NCT01708902|B1|Baseline|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78426|NCT01708902|P7|Participant Flow|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78427|NCT01708902|P6|Participant Flow|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.~(Data up to week 12)"
78428|NCT01708902|P5|Participant Flow|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
78429|NCT01708902|P4|Participant Flow|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
78430|NCT01708902|P3|Participant Flow|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
78431|NCT01708902|P2|Participant Flow|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
78432|NCT01708902|P1|Participant Flow|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
78433|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78434|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78435|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78436|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78437|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78438|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78439|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78440|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78441|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78442|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78443|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78444|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78445|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78446|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78447|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78448|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78449|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78450|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78451|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78452|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78453|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78454|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78455|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78456|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78457|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78458|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78459|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78461|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78462|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78463|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78464|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78465|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78466|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78467|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78468|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78469|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78470|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78471|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78472|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78473|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78474|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78475|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78476|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78477|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
78478|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
78479|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
78480|NCT01708902|E10|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~Data from week 12 to week 24."
78481|NCT01708902|E9|Reported Event|APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12|Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
78482|NCT01708902|E8|Reported Event|APG: Linagliptin 5mg After Week 12|Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
78483|NCT01708902|E7|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
78484|NCT01708902|E6|Reported Event|APG: Linagliptin 5mg QD up to Week 12|"Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
78485|NCT01708902|E5|Reported Event|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
78486|NCT01708902|E4|Reported Event|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
78487|NCT01708902|E3|Reported Event|Main: Metformin 1000mg BID|Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
78488|NCT01708902|E2|Reported Event|Main: Metformin 500mg BID|Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
78489|NCT01708902|E1|Reported Event|Main: Linagliptin 5mg QD|Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
78490|NCT01708525|B1|Baseline|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
78491|NCT01708525|P1|Participant Flow|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
78492|NCT01708525|O2|Outcome|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin"
78493|NCT01708525|O1|Outcome|Untreated Tissue|Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
78494|NCT01708525|E1|Reported Event|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
78517|NCT01708278|B1|Baseline|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78599|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78495|NCT01708317|B1|Baseline|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
78496|NCT01708317|P1|Participant Flow|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
78497|NCT01708317|O4|Outcome|Final Education Period|Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
78498|NCT01708317|O3|Outcome|ACASI + Education|Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
78499|NCT01708317|O2|Outcome|Initial Education Period|Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
78500|NCT01708317|O1|Outcome|Historical Control|Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
78501|NCT01708317|E1|Reported Event|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
78502|NCT01708291|B3|Baseline|Total|Total of all reporting groups
78503|NCT01708291|B2|Baseline|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
78504|NCT01708291|B1|Baseline|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
78505|NCT01708291|P2|Participant Flow|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
78506|NCT01708291|P1|Participant Flow|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
78507|NCT01708291|O2|Outcome|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
78508|NCT01708291|O1|Outcome|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
78509|NCT01708291|E2|Reported Event|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
78510|NCT01708291|E1|Reported Event|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
78511|NCT01708278|B7|Baseline|Total|Total of all reporting groups
78512|NCT01708278|B6|Baseline|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78513|NCT01708278|B5|Baseline|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78514|NCT01708278|B4|Baseline|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78515|NCT01708278|B3|Baseline|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78516|NCT01708278|B2|Baseline|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78543|NCT01708187|B2|Baseline|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
78518|NCT01708278|P6|Participant Flow|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78519|NCT01708278|P5|Participant Flow|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78520|NCT01708278|P4|Participant Flow|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78521|NCT01708278|P3|Participant Flow|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78522|NCT01708278|P2|Participant Flow|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78523|NCT01708278|P1|Participant Flow|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78524|NCT01708278|O6|Outcome|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78525|NCT01708278|O5|Outcome|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78526|NCT01708278|O4|Outcome|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78527|NCT01708278|O3|Outcome|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78528|NCT01708278|O2|Outcome|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78529|NCT01708278|O1|Outcome|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78530|NCT01708278|E6|Reported Event|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78531|NCT01708278|E5|Reported Event|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78532|NCT01708278|E4|Reported Event|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78533|NCT01708278|E3|Reported Event|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78534|NCT01708278|E2|Reported Event|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
78535|NCT01708278|E1|Reported Event|Sugar Chew-Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
78536|NCT01708213|B1|Baseline|Dermal Filler - Aline HA|"Single armed study~Aline HA: Implantable dermal filler"
78537|NCT01708213|P1|Participant Flow|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
78538|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
78539|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
78540|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
78541|NCT01708213|E1|Reported Event|Dermal Filler - Aline HA|To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
78542|NCT01708187|B3|Baseline|Total|Total of all reporting groups
78544|NCT01708187|B1|Baseline|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
78545|NCT01708187|P2|Participant Flow|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
78546|NCT01708187|P1|Participant Flow|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
78547|NCT01708187|O2|Outcome|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
78548|NCT01708187|O1|Outcome|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
78549|NCT01708187|E2|Reported Event|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
78550|NCT01708187|E1|Reported Event|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
78551|NCT01708122|B3|Baseline|Total|Total of all reporting groups
78552|NCT01708122|B2|Baseline|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
78553|NCT01708122|B1|Baseline|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
78554|NCT01708122|P2|Participant Flow|Fentanyl|Subjects receiving either 50mcg or 100mcg
78555|NCT01708122|P1|Participant Flow|Placebo|"Subjects will receive 0.1 mL of intranasal saline as placebo.~saline: Sodium Chloride 0.9% intranasal spray"
78556|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
78557|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
78558|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
78559|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
78560|NCT01708122|E2|Reported Event|Placebo|"Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
78561|NCT01708122|E1|Reported Event|Fentanyl|"Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)~Fentanyl: 100 mcg in 1 mL intranasal spray"
78562|NCT01708057|B1|Baseline|Total Baseline|All Patients population
78563|NCT01708057|P3|Participant Flow|DCEBFA|AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
78564|NCT01708057|P2|Participant Flow|FEADBC|Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug
78565|NCT01708057|P1|Participant Flow|AFBECD|AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug
78566|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78567|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78568|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78569|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78570|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78571|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78572|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78573|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78574|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78575|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78576|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78577|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78578|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78579|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78580|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78581|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78582|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78583|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78584|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78585|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78586|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78587|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78588|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78589|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78590|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78591|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78592|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78593|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78594|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78595|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78600|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78601|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78602|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78603|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78604|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78605|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78606|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78607|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78608|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78609|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78610|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78611|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
78612|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78613|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78614|NCT01708057|E6|Reported Event|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
78615|NCT01708057|E5|Reported Event|18ug Spiriva|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
78616|NCT01708057|E4|Reported Event|900 ug AZD8683|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;
78617|NCT01708057|E3|Reported Event|300 ug AZD8683|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78618|NCT01708057|E2|Reported Event|150 ug AZD8683|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78619|NCT01708057|E1|Reported Event|50ug AZD8683|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
78620|NCT01707667|B3|Baseline|Total|Total of all reporting groups
78621|NCT01707667|B2|Baseline|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
78622|NCT01707667|B1|Baseline|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
78623|NCT01707667|P2|Participant Flow|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
78624|NCT01707667|P1|Participant Flow|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
78625|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78626|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78627|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78628|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78629|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78630|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78631|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78632|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78633|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78634|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78635|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78636|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78637|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78638|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78639|NCT01707667|E2|Reported Event|Polyethylene Glycol|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
78640|NCT01707667|E1|Reported Event|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
78641|NCT01707654|B1|Baseline|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
78642|NCT01707654|P1|Participant Flow|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
79126|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
78643|NCT01707654|O1|Outcome|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
78644|NCT01707654|E1|Reported Event|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
78645|NCT01707238|B3|Baseline|Total|Total of all reporting groups
78646|NCT01707238|B2|Baseline|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
78647|NCT01707238|B1|Baseline|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
78648|NCT01707238|P2|Participant Flow|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
78649|NCT01707238|P1|Participant Flow|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
78650|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78651|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78652|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78653|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78654|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78655|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78656|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78657|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).
78658|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78659|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78660|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78661|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
78662|NCT01707238|E2|Reported Event|Etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
78663|NCT01707238|E1|Reported Event|Stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
78664|NCT01707225|B1|Baseline|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
78665|NCT01707225|P1|Participant Flow|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
78927|NCT01705652|E2|Reported Event|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
78666|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
78667|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
78668|NCT01707225|E1|Reported Event|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
78669|NCT01707095|B3|Baseline|Total|Total of all reporting groups
78670|NCT01707095|B2|Baseline|Unbundling of Cords|"The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another~Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another"
78671|NCT01707095|B1|Baseline|Bundling of Cords|"The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.~Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy."
78672|NCT01707095|P2|Participant Flow|Unbundled / Separated|Active electrode cord and camera cord separated
78673|NCT01707095|P1|Participant Flow|Bundled|Active electrode cord and camera cord parallel
78674|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
78675|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
78676|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
78677|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
78678|NCT01707095|E2|Reported Event|Unbundled / Separated|Active electrode cord and camera cord separated
78679|NCT01707095|E1|Reported Event|Bundled|Active electrode cord and camera cord parallel
78680|NCT01706926|B5|Baseline|Total|Total of all reporting groups
78681|NCT01706926|B4|Baseline|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78682|NCT01706926|B3|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78683|NCT01706926|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78684|NCT01706926|B1|Baseline|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78685|NCT01706926|P4|Participant Flow|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78686|NCT01706926|P3|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78687|NCT01706926|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78688|NCT01706926|P1|Participant Flow|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78689|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78690|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78691|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78692|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78693|NCT01706926|O3|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78694|NCT01706926|O2|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78695|NCT01706926|O1|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78696|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78697|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78698|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78699|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78700|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78701|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78702|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78703|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78704|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78705|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78706|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78707|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78708|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78709|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78710|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78711|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78712|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78713|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78714|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78715|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78716|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78717|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78718|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78719|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78720|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78721|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78722|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78723|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78724|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78725|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78726|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78727|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78728|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78729|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78730|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78731|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78732|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78733|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78734|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78735|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78736|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78737|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78738|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78739|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78740|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78741|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78742|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78743|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78744|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78745|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78746|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78747|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78748|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78749|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78750|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78751|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78752|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78753|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78754|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78755|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78756|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78757|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78758|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78759|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78760|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78761|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78762|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78763|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78764|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78765|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78766|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78767|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78768|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78769|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78770|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78771|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78772|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78773|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78774|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78775|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78776|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78777|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78778|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78779|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78780|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78781|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78782|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78783|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78784|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78785|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78786|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78787|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78788|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78789|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78790|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78791|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78792|NCT01706926|E4|Reported Event|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78793|NCT01706926|E3|Reported Event|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78794|NCT01706926|E2|Reported Event|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
78795|NCT01706926|E1|Reported Event|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
78796|NCT01706822|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
78797|NCT01706822|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78798|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78799|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78800|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78801|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78802|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
78803|NCT01706822|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
78804|NCT01706770|B3|Baseline|Total|Total of all reporting groups
78805|NCT01706770|B2|Baseline|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78806|NCT01706770|B1|Baseline|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78807|NCT01706770|P2|Participant Flow|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78808|NCT01706770|P1|Participant Flow|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78809|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78810|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78811|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78812|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78813|NCT01706770|E2|Reported Event|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78814|NCT01706770|E1|Reported Event|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
78815|NCT01706666|B4|Baseline|Total|Total of all reporting groups
78816|NCT01706666|B3|Baseline|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78817|NCT01706666|B2|Baseline|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78818|NCT01706666|B1|Baseline|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78819|NCT01706666|P3|Participant Flow|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78820|NCT01706666|P2|Participant Flow|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78821|NCT01706666|P1|Participant Flow|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78822|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78823|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78824|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78825|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78826|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78827|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78828|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78829|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78830|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78831|NCT01706666|E3|Reported Event|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
78832|NCT01706666|E2|Reported Event|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78833|NCT01706666|E1|Reported Event|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
78834|NCT01706588|B6|Baseline|Total|Total of all reporting groups
78835|NCT01706588|B5|Baseline|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78836|NCT01706588|B4|Baseline|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78837|NCT01706588|B3|Baseline|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78838|NCT01706588|B2|Baseline|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78839|NCT01706588|B1|Baseline|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78840|NCT01706588|P5|Participant Flow|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78841|NCT01706588|P4|Participant Flow|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78842|NCT01706588|P3|Participant Flow|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78843|NCT01706588|P2|Participant Flow|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78844|NCT01706588|P1|Participant Flow|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78845|NCT01706588|O5|Outcome|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78846|NCT01706588|O4|Outcome|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78847|NCT01706588|O3|Outcome|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78848|NCT01706588|O2|Outcome|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78849|NCT01706588|O1|Outcome|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78850|NCT01706588|E5|Reported Event|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78851|NCT01706588|E4|Reported Event|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78852|NCT01706588|E3|Reported Event|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78853|NCT01706588|E2|Reported Event|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78854|NCT01706588|E1|Reported Event|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
78928|NCT01705652|E1|Reported Event|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
78855|NCT01706575|B1|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78856|NCT01706575|P1|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78857|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78858|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78859|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78860|NCT01706575|E1|Reported Event|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
78861|NCT01706549|B1|Baseline|Postoperative Pain|Observational study on posthysterectomy pain
78862|NCT01706549|P1|Participant Flow|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
78863|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
78864|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
78865|NCT01706549|E1|Reported Event|Posthysterectomy Pain|This was an observational study, thus no adverse events were collected.
78866|NCT01706328|B3|Baseline|Total|Total of all reporting groups
78867|NCT01706328|B2|Baseline|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78868|NCT01706328|B1|Baseline|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78869|NCT01706328|P3|Participant Flow|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78870|NCT01706328|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78871|NCT01706328|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
78872|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78873|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78874|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78875|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78929|NCT01705574|B3|Baseline|Total|Total of all reporting groups
78930|NCT01705574|B2|Baseline|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
78876|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78877|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78878|NCT01706328|E2|Reported Event|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
78879|NCT01706328|E1|Reported Event|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
78880|NCT01706159|B3|Baseline|Total|Total of all reporting groups
78881|NCT01706159|B2|Baseline|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78882|NCT01706159|B1|Baseline|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78883|NCT01706159|P2|Participant Flow|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78884|NCT01706159|P1|Participant Flow|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78885|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78886|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78887|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78888|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78889|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78890|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78891|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78892|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78893|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78894|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78895|NCT01706159|E2|Reported Event|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
78896|NCT01706159|E1|Reported Event|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
78897|NCT01706146|B1|Baseline|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
78898|NCT01706146|P1|Participant Flow|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
78899|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
78900|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
78931|NCT01705574|B1|Baseline|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
78901|NCT01706146|E1|Reported Event|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
78902|NCT01705717|B3|Baseline|Total|Total of all reporting groups
78903|NCT01705717|B2|Baseline|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78904|NCT01705717|B1|Baseline|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78905|NCT01705717|P2|Participant Flow|Hepatitis C Virus (HCV) – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78906|NCT01705717|P1|Participant Flow|Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78907|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78908|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78909|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78910|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78911|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78912|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78913|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78914|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78915|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78916|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78917|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78918|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78919|NCT01705717|E1|Reported Event|All Participants|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
78920|NCT01705652|B3|Baseline|Total|Total of all reporting groups
78921|NCT01705652|B2|Baseline|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
78922|NCT01705652|B1|Baseline|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
78923|NCT01705652|P2|Participant Flow|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
78924|NCT01705652|P1|Participant Flow|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
78925|NCT01705652|O2|Outcome|Surgery Group|Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
78926|NCT01705652|O1|Outcome|Radiation Group|Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
78932|NCT01705574|P2|Participant Flow|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (Truvada®; 200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
78933|NCT01705574|P1|Participant Flow|E/C/F/TDF|Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily for 48 weeks
78934|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
78935|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
78936|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
78937|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
78938|NCT01705574|E2|Reported Event|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
78939|NCT01705574|E1|Reported Event|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
78940|NCT01705496|B1|Baseline|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78941|NCT01705496|P1|Participant Flow|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78942|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78943|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78944|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78945|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78946|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78947|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78948|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78949|NCT01705496|E1|Reported Event|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
78950|NCT01705145|B1|Baseline|Ivacaftor|"Part A: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
78951|NCT01705145|P1|Participant Flow|Ivacaftor|"Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than [<] 14 kilograms [kg]) or 75 mg (for participants weighing greater than or equal to [>=] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
78952|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78953|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78954|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78955|NCT01705145|O1|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78956|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78957|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78958|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78959|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78960|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78961|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78962|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78963|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78964|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78965|NCT01705145|O1|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78966|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78967|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78968|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78969|NCT01705145|O3|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78970|NCT01705145|O2|Outcome|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78971|NCT01705145|O1|Outcome|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78972|NCT01705145|E6|Reported Event|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78973|NCT01705145|E5|Reported Event|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78974|NCT01705145|E4|Reported Event|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
78975|NCT01705145|E3|Reported Event|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78976|NCT01705145|E2|Reported Event|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78977|NCT01705145|E1|Reported Event|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
78978|NCT01704976|B3|Baseline|Total|Total of all reporting groups
78979|NCT01704976|B2|Baseline|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78980|NCT01704976|B1|Baseline|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78981|NCT01704976|P2|Participant Flow|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78982|NCT01704976|P1|Participant Flow|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78983|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78984|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78985|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78986|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78987|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78988|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78989|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78990|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78991|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78992|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78993|NCT01704976|E2|Reported Event|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
78994|NCT01704976|E1|Reported Event|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
78995|NCT01704846|B3|Baseline|Total|Total of all reporting groups
78996|NCT01704846|B2|Baseline|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
78997|NCT01704846|B1|Baseline|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
78998|NCT01704846|P2|Participant Flow|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
78999|NCT01704846|P1|Participant Flow|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
79000|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79001|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79002|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79003|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79004|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79005|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79006|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79007|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79008|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79009|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79010|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79011|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79012|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79013|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79014|NCT01704846|E2|Reported Event|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79015|NCT01704846|E1|Reported Event|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
79016|NCT01704755|B3|Baseline|Total|Total of all reporting groups
79116|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79017|NCT01704755|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79018|NCT01704755|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79019|NCT01704755|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79020|NCT01704755|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79021|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79022|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79023|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79024|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79025|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79026|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79027|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79028|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79029|NCT01704755|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
79030|NCT01704755|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
79031|NCT01704651|B3|Baseline|Total|Total of all reporting groups
79032|NCT01704651|B2|Baseline|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
79033|NCT01704651|B1|Baseline|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
79034|NCT01704651|P2|Participant Flow|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
79035|NCT01704651|P1|Participant Flow|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
79036|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
79037|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
79038|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
79039|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
79040|NCT01704651|E2|Reported Event|Placebo|Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
79041|NCT01704651|E1|Reported Event|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
79042|NCT01704599|B1|Baseline|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
79043|NCT01704599|P1|Participant Flow|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
79044|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks (week 28)."
79045|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject."
79046|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks."
79047|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
79048|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
79049|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
79050|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
79051|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
79052|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
79053|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
79054|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
79055|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
79056|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
79057|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis.
79058|NCT01704599|O1|Outcome|Humira Plus 3 B Vitamins|adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
79059|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
79060|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
79061|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
79062|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
79063|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
79064|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
79065|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
79066|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
79067|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
79068|NCT01704599|E1|Reported Event|Humira Then Humira Plus 3 B Vitamins|Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
79069|NCT01704521|B3|Baseline|Total|Total of all reporting groups
79070|NCT01704521|B2|Baseline|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
79071|NCT01704521|B1|Baseline|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
79072|NCT01704521|P2|Participant Flow|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
79073|NCT01704521|P1|Participant Flow|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
79074|NCT01704521|O2|Outcome|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
79075|NCT01704521|O1|Outcome|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
79076|NCT01704521|E2|Reported Event|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
79077|NCT01704521|E1|Reported Event|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
79078|NCT01704495|B5|Baseline|Total|Total of all reporting groups
79079|NCT01704495|B4|Baseline|Placebo|Placebo oral capsules self-administred twice daily
79080|NCT01704495|B3|Baseline|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79081|NCT01704495|B2|Baseline|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79082|NCT01704495|B1|Baseline|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79083|NCT01704495|P4|Participant Flow|Placebo|Placebo oral capsules self-administred twice daily
79084|NCT01704495|P3|Participant Flow|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79085|NCT01704495|P2|Participant Flow|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79086|NCT01704495|P1|Participant Flow|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79087|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79088|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79089|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79090|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79091|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79092|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79093|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79094|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79095|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79096|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79097|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79098|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79099|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79100|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79101|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79102|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79103|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79104|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79105|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79106|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79107|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79108|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79109|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79110|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79111|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79112|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79113|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79114|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79115|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79127|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79128|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79129|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79130|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79131|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79132|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79133|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79134|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79135|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79136|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79137|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79138|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79139|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79140|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79141|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79142|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79143|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79144|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79145|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79146|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79147|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79148|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79149|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79150|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79151|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79152|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79153|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79154|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79155|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79156|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79157|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79158|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79159|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79160|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79161|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79162|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79163|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79164|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79165|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79166|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79167|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79168|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79169|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79170|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79171|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79172|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79173|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79174|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79175|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79176|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79177|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79178|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79179|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79180|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79181|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79182|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79183|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79184|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79185|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79186|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79187|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79188|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79189|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79190|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79191|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79192|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79193|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79194|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79195|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79196|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79197|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79198|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79199|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79200|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79201|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79202|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79203|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79204|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79205|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79206|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79207|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79208|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79209|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79210|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79211|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79212|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79213|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79214|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79215|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79216|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79217|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79218|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79219|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79220|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79221|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79222|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79223|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79224|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79225|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79226|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79227|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79228|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79229|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79230|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79231|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79232|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79233|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79234|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79235|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79236|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79237|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79238|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79239|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79240|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79241|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79242|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79243|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79244|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79245|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79246|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79247|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79248|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79249|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79250|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79251|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
79252|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79253|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79254|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79255|NCT01704495|E4|Reported Event|Placebo|Placebo oral capsules self-administered twice daily
79256|NCT01704495|E3|Reported Event|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
79257|NCT01704495|E2|Reported Event|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
79258|NCT01704495|E1|Reported Event|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
79259|NCT01704261|B3|Baseline|Total|Total of all reporting groups
79260|NCT01704261|B2|Baseline|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79261|NCT01704261|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79262|NCT01704261|P2|Participant Flow|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79263|NCT01704261|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79264|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79265|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79266|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79267|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79268|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79269|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79270|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79271|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79272|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79273|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79274|NCT01704261|E2|Reported Event|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79275|NCT01704261|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
79276|NCT01704079|B3|Baseline|Total|Total of all reporting groups
79277|NCT01704079|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79278|NCT01704079|B1|Baseline|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79315|NCT01703858|E4|Reported Event|Pantoprazole 40mg|Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
79279|NCT01704079|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79280|NCT01704079|P1|Participant Flow|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79281|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79282|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79283|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79284|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79285|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79286|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79287|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79288|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79289|NCT01704079|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79290|NCT01704079|E1|Reported Event|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
79291|NCT01703858|B4|Baseline|Total|Total of all reporting groups
79292|NCT01703858|B3|Baseline|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79293|NCT01703858|B2|Baseline|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79316|NCT01703858|E3|Reported Event|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
79396|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79294|NCT01703858|B1|Baseline|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79295|NCT01703858|P3|Participant Flow|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79296|NCT01703858|P2|Participant Flow|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79297|NCT01703858|P1|Participant Flow|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
79298|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
79299|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
79300|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
79301|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
79302|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
79303|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
79304|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
79305|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
79306|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
79307|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
79308|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
79309|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
79310|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
79311|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
79312|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
79313|NCT01703858|E6|Reported Event|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
79314|NCT01703858|E5|Reported Event|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
79395|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79317|NCT01703858|E2|Reported Event|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
79318|NCT01703858|E1|Reported Event|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
79319|NCT01703845|B3|Baseline|Total|Total of all reporting groups
79320|NCT01703845|B2|Baseline|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79321|NCT01703845|B1|Baseline|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79322|NCT01703845|P2|Participant Flow|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79323|NCT01703845|P1|Participant Flow|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79324|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79325|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79326|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79327|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79328|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79329|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79330|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79331|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79332|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79333|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79334|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79335|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79336|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79337|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79338|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79339|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79340|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79341|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79342|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79343|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79344|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79345|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79346|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79347|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79348|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79349|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79350|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79351|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79352|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79353|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79354|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79355|NCT01703845|E2|Reported Event|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79356|NCT01703845|E1|Reported Event|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
79357|NCT01703832|B3|Baseline|Total|Total of all reporting groups
79358|NCT01703832|B2|Baseline|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79359|NCT01703832|B1|Baseline|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79360|NCT01703832|P2|Participant Flow|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79361|NCT01703832|P1|Participant Flow|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79362|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79363|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79364|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79365|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79366|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79367|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79368|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79369|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79370|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79371|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79372|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79373|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79374|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79375|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79376|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79377|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79378|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79379|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79380|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79381|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79382|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79383|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79384|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79385|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79386|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79387|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79388|NCT01703832|E2|Reported Event|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
79389|NCT01703832|E1|Reported Event|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
79390|NCT01703819|B3|Baseline|Total|Total of all reporting groups
79391|NCT01703819|B2|Baseline|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79392|NCT01703819|B1|Baseline|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to~-30 minutes~Neurexan®"
79393|NCT01703819|P2|Participant Flow|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79394|NCT01703819|P1|Participant Flow|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79397|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79398|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79399|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79400|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79401|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79402|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79403|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79404|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79405|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79406|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79407|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79408|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79409|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79410|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79411|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79412|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79413|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79414|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79415|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79416|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79417|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79418|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79419|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79420|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79421|NCT01703819|E2|Reported Event|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
79422|NCT01703819|E1|Reported Event|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
79423|NCT01703702|B3|Baseline|Total|Total of all reporting groups
79424|NCT01703702|B2|Baseline|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
79425|NCT01703702|B1|Baseline|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
79426|NCT01703702|P2|Participant Flow|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
79427|NCT01703702|P1|Participant Flow|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
79428|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
79429|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
79430|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
79431|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
79432|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
79433|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
79434|NCT01703702|O2|Outcome|Control Scan/Diagnosis Concordant|Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
79435|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Concordant|Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
79436|NCT01703702|O2|Outcome|Control Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
79437|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
79438|NCT01703702|O2|Outcome|Mild Impairment AB-|Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
79439|NCT01703702|O1|Outcome|Mild Impairment AB+|Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
79440|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
79441|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
79442|NCT01703702|E1|Reported Event|Safety Population|620 patients received florbetapir (18F) and comprise the Safety Population.
79443|NCT01703663|B1|Baseline|All Participants|
79444|NCT01703663|P2|Participant Flow|Control Night First Night, EPAP Therapy Second Night|During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
79445|NCT01703663|P1|Participant Flow|EPAP Therapy First Night, Then Control Night|During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.
79446|NCT01703663|O2|Outcome|Control Night|Raw data from control night (not taking into account period effect).
79447|NCT01703663|O1|Outcome|EPAP Night|Raw data from EPAP night (not taking into account period effect).
79448|NCT01703663|E2|Reported Event|Control Night|
79449|NCT01703663|E1|Reported Event|EPAP Night|
79450|NCT01703286|B1|Baseline|Total Participants|All study participants
79451|NCT01703286|P6|Participant Flow|L 5/ Pbo/ G1-4/|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79452|NCT01703286|P5|Participant Flow|Pbo/ L 5/ G1-4|Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79453|NCT01703286|P4|Participant Flow|G1-4/ Pbo/ L 5|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
79454|NCT01703286|P3|Participant Flow|G 1-4/ L 5/ Pbo|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
79455|NCT01703286|P2|Participant Flow|L 5/ G 1-4/ Pbo|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
79456|NCT01703286|P1|Participant Flow|Pbo/ G1-4/ L 5|Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
79457|NCT01703286|O6|Outcome|Rep - Placebo|Residual effect period - Placebo
79458|NCT01703286|O5|Outcome|REP - Glimepiride 1-4 mg|Residual effect period - Glimepiride 1-4 mg
79459|NCT01703286|O4|Outcome|REP - Linagliptin 5 mg|Residual effect period - Linagliptin 5 mg
79460|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
79461|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79462|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
79463|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
79464|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79465|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
79466|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
79467|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79468|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
79469|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
79470|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79471|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
79472|NCT01703286|E3|Reported Event|Placebo|Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
79473|NCT01703286|E2|Reported Event|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
79474|NCT01703286|E1|Reported Event|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
79475|NCT01703260|B4|Baseline|Total|Total of all reporting groups
79476|NCT01703260|B3|Baseline|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79477|NCT01703260|B2|Baseline|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79478|NCT01703260|B1|Baseline|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79479|NCT01703260|P3|Participant Flow|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79480|NCT01703260|P2|Participant Flow|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79481|NCT01703260|P1|Participant Flow|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79482|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79483|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79484|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79739|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79485|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79486|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79487|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79488|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79489|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79490|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79491|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79492|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79493|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79494|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79495|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79496|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79497|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79498|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79499|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79500|NCT01703260|E3|Reported Event|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
79501|NCT01703260|E2|Reported Event|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
79502|NCT01703260|E1|Reported Event|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
79503|NCT01703221|B4|Baseline|Total|Total of all reporting groups
79504|NCT01703221|B3|Baseline|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
79505|NCT01703221|B2|Baseline|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
79506|NCT01703221|B1|Baseline|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
79507|NCT01703221|P3|Participant Flow|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
79508|NCT01703221|P2|Participant Flow|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
79509|NCT01703221|P1|Participant Flow|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
79510|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79511|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79512|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79513|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79514|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79515|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79516|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
79517|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
79518|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
79519|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79520|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79521|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79522|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
79523|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
79524|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
79525|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79526|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79527|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79528|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79529|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79530|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79531|NCT01703221|E6|Reported Event|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
79532|NCT01703221|E5|Reported Event|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
79533|NCT01703221|E4|Reported Event|Omarigliptin (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
79534|NCT01703221|E3|Reported Event|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
79535|NCT01703221|E2|Reported Event|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
79536|NCT01703221|E1|Reported Event|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
79537|NCT01703091|B3|Baseline|Total|Total of all reporting groups
79538|NCT01703091|B2|Baseline|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79539|NCT01703091|B1|Baseline|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79540|NCT01703091|P2|Participant Flow|Placebo Plus Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79541|NCT01703091|P1|Participant Flow|Ramucirumab Plus Docetaxel|Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79542|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79543|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79544|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79545|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79546|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79547|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79548|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79549|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79550|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79551|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79552|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79553|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79554|NCT01703091|E2|Reported Event|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79555|NCT01703091|E1|Reported Event|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
79556|NCT01703000|B1|Baseline|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79557|NCT01703000|P1|Participant Flow|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79558|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79559|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79560|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79741|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79561|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79562|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79563|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79564|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79565|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79566|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79567|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79568|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79569|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79570|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79571|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79572|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79573|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79574|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79575|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79576|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79577|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79578|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79579|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79580|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79581|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79582|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79583|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79584|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79585|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79586|NCT01703000|E1|Reported Event|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
79587|NCT01702961|B1|Baseline|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79588|NCT01702961|P1|Participant Flow|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79742|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79589|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79590|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79591|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79592|NCT01702961|E1|Reported Event|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
79593|NCT01702532|B3|Baseline|Total|Total of all reporting groups
79594|NCT01702532|B2|Baseline|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
79595|NCT01702532|B1|Baseline|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
79596|NCT01702532|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
79597|NCT01702532|P1|Participant Flow|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
79598|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
79599|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
79600|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes)
79601|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
79602|NCT01702532|E2|Reported Event|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
79603|NCT01702532|E1|Reported Event|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
79604|NCT01702519|B3|Baseline|Total|Total of all reporting groups
79605|NCT01702519|B2|Baseline|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
79606|NCT01702519|B1|Baseline|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
79607|NCT01702519|P2|Participant Flow|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
79608|NCT01702519|P1|Participant Flow|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
79609|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
79610|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
79611|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
79612|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
79613|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
79614|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
79615|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with reference adhesive, for 24 hours
79616|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours
79617|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
79618|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
79619|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
79620|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
79621|NCT01702519|E2|Reported Event|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
79622|NCT01702519|E1|Reported Event|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
79623|NCT01702454|B3|Baseline|Total|Total of all reporting groups
79624|NCT01702454|B2|Baseline|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79625|NCT01702454|B1|Baseline|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79626|NCT01702454|P2|Participant Flow|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79627|NCT01702454|P1|Participant Flow|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79628|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79629|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79630|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79631|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79632|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79633|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79634|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79635|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79636|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79637|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79638|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79639|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|SuSubjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79640|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79641|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79642|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79740|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79643|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79644|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79645|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79646|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79647|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79648|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79649|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79650|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79651|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79652|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79653|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79654|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79655|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79656|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79657|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79658|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79659|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79660|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79661|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79662|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79663|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79664|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79665|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79666|NCT01702454|E2|Reported Event|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79667|NCT01702454|E1|Reported Event|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
79668|NCT01702363|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79669|NCT01702363|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
79670|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79671|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79672|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79673|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79674|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79675|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79676|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79677|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79678|NCT01702363|O1|Outcome|MEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79679|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79680|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79681|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79682|NCT01702363|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
79683|NCT01702311|B3|Baseline|Total|Total of all reporting groups
79684|NCT01702311|B2|Baseline|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
79685|NCT01702311|B1|Baseline|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
79686|NCT01702311|P2|Participant Flow|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
79687|NCT01702311|P1|Participant Flow|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
79688|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
79689|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
79690|NCT01702311|E2|Reported Event|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
79691|NCT01702311|E1|Reported Event|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
79692|NCT01702298|B1|Baseline|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79693|NCT01702298|P1|Participant Flow|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79694|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79695|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79696|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79697|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79698|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79699|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79700|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79701|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79702|NCT01702298|E1|Reported Event|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
79703|NCT01702259|B3|Baseline|Total|Total of all reporting groups
79704|NCT01702259|B2|Baseline|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79705|NCT01702259|B1|Baseline|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79706|NCT01702259|P2|Participant Flow|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79707|NCT01702259|P1|Participant Flow|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light."
79708|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79709|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79710|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79711|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79712|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79713|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79714|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79715|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79716|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79717|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79718|NCT01702259|E2|Reported Event|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
79719|NCT01702259|E1|Reported Event|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
79720|NCT01702246|B1|Baseline|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
79721|NCT01702246|P1|Participant Flow|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
79722|NCT01702246|O2|Outcome|Simvastatin Treatment|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
79723|NCT01702246|O1|Outcome|Baseline Cholesterol|mean cholesterol level (mmol/L) prior to treatment with simvastatin
79724|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
79725|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
79726|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
79727|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
79728|NCT01702246|E1|Reported Event|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
79729|NCT01702233|B4|Baseline|Total|Total of all reporting groups
79730|NCT01702233|B3|Baseline|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79731|NCT01702233|B2|Baseline|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79732|NCT01702233|B1|Baseline|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79733|NCT01702233|P3|Participant Flow|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79734|NCT01702233|P2|Participant Flow|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79735|NCT01702233|P1|Participant Flow|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79736|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79737|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79738|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79743|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79744|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79745|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79746|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79747|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79748|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79749|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79750|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79751|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79752|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79753|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79754|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79755|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79756|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79757|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79758|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79759|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79760|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79761|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79762|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79763|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79764|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79765|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79766|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79767|NCT01702233|E3|Reported Event|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79768|NCT01702233|E2|Reported Event|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
79769|NCT01702233|E1|Reported Event|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
79770|NCT01702025|B5|Baseline|Total|Total of all reporting groups
79771|NCT01702025|B4|Baseline|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
79772|NCT01702025|B3|Baseline|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
79773|NCT01702025|B2|Baseline|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
79774|NCT01702025|B1|Baseline|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
79775|NCT01702025|P4|Participant Flow|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
79776|NCT01702025|P3|Participant Flow|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
79777|NCT01702025|P2|Participant Flow|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
79778|NCT01702025|P1|Participant Flow|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
79779|NCT01702025|O8|Outcome|Hypoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose hypoxia
79780|NCT01702025|O7|Outcome|Normoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose normoxia
79781|NCT01702025|O6|Outcome|Hypoxia Methazolamide|Methazolamide: single dose hypoxia
79782|NCT01702025|O5|Outcome|Normoxia Methazolamide|Methazolamide single dose Normoxia
79783|NCT01702025|O4|Outcome|Hypoxia Aminophylline|Aminophylline:single dose hypoxia
79784|NCT01702025|O3|Outcome|Normoxia Aminophylline|Aminophylline:single dose Normoxia
79785|NCT01702025|O2|Outcome|Hypoxia Placebo|Placebo: single dose hypoxia
79786|NCT01702025|O1|Outcome|Normoxia Placebo|Placebo: single dose Normoxia
79787|NCT01702025|E4|Reported Event|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
79788|NCT01702025|E3|Reported Event|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
79789|NCT01702025|E2|Reported Event|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
79790|NCT01702025|E1|Reported Event|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
79791|NCT01701999|B3|Baseline|Total|Total of all reporting groups
79792|NCT01701999|B2|Baseline|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79793|NCT01701999|B1|Baseline|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79831|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79794|NCT01701999|P2|Participant Flow|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79795|NCT01701999|P1|Participant Flow|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79796|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79797|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79798|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79799|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79800|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79801|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79802|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79803|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79804|NCT01701999|E2|Reported Event|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
79805|NCT01701999|E1|Reported Event|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
79806|NCT01701622|B1|Baseline|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
79807|NCT01701622|P1|Participant Flow|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
79808|NCT01701622|O2|Outcome|Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
79809|NCT01701622|O1|Outcome|Allopurinol|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
79810|NCT01701622|E1|Reported Event|Febuxostat|Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
79811|NCT01701414|B3|Baseline|Total|Total of all reporting groups
79812|NCT01701414|B2|Baseline|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
79832|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79833|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79834|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79813|NCT01701414|B1|Baseline|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
79814|NCT01701414|P2|Participant Flow|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
79815|NCT01701414|P1|Participant Flow|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
79816|NCT01701414|O2|Outcome|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
79817|NCT01701414|O1|Outcome|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
79818|NCT01701414|E2|Reported Event|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
79819|NCT01701414|E1|Reported Event|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
79820|NCT01701401|B5|Baseline|Total|Total of all reporting groups
79821|NCT01701401|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79822|NCT01701401|B3|Baseline|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79823|NCT01701401|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79824|NCT01701401|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79825|NCT01701401|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79826|NCT01701401|P3|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79827|NCT01701401|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79828|NCT01701401|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
79829|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79830|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79835|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79836|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79837|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79838|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79839|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79840|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79841|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79842|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79843|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79844|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79845|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79846|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79847|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79848|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79849|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79850|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79851|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79852|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79853|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79854|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79855|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79856|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79857|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79858|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79859|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79860|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79861|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79862|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79863|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79864|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79865|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79866|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79867|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79868|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79869|NCT01701401|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
79870|NCT01701401|E3|Reported Event|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
79871|NCT01701401|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
79872|NCT01701401|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
79873|NCT01701375|B1|Baseline|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
79874|NCT01701375|P1|Participant Flow|Arm 1|"PD 0332991 125 was given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
79875|NCT01701375|O1|Outcome|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
79876|NCT01701375|E1|Reported Event|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
79877|NCT01701271|B1|Baseline|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79878|NCT01701271|P1|Participant Flow|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79879|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79880|NCT01701271|O1|Outcome|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79881|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79882|NCT01701271|E1|Reported Event|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
79883|NCT01701245|B3|Baseline|Total|Total of all reporting groups
79884|NCT01701245|B2|Baseline|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79885|NCT01701245|B1|Baseline|Standard of Care|No intervention, standard of care
79886|NCT01701245|P2|Participant Flow|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79887|NCT01701245|P1|Participant Flow|Standard of Care|No intervention, standard of care
79888|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79889|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
79890|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79891|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
79892|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79893|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
79894|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79895|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
79896|NCT01701245|E2|Reported Event|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
79897|NCT01701245|E1|Reported Event|Standard of Care|No intervention, standard of care
79898|NCT01701102|B5|Baseline|Total|Total of all reporting groups
79899|NCT01701102|B4|Baseline|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79900|NCT01701102|B3|Baseline|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79901|NCT01701102|B2|Baseline|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79902|NCT01701102|B1|Baseline|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79903|NCT01701102|P4|Participant Flow|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
79904|NCT01701102|P3|Participant Flow|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
79905|NCT01701102|P2|Participant Flow|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
79906|NCT01701102|P1|Participant Flow|Mepivacaine 37.5 mg|Mepivacaine (37.5 mg)
79907|NCT01701102|O4|Outcome|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79908|NCT01701102|O3|Outcome|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79909|NCT01701102|O2|Outcome|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79910|NCT01701102|O1|Outcome|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79911|NCT01701102|E4|Reported Event|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79912|NCT01701102|E3|Reported Event|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79913|NCT01701102|E2|Reported Event|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79914|NCT01701102|E1|Reported Event|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
79915|NCT01701063|B4|Baseline|Total|Total of all reporting groups
79974|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
79975|NCT01701024|E2|Reported Event|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79976|NCT01701024|E1|Reported Event|ACYC|ACYC active, topically applied to the face for 12 weeks
79916|NCT01701063|B3|Baseline|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79917|NCT01701063|B2|Baseline|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79918|NCT01701063|B1|Baseline|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79919|NCT01701063|P3|Participant Flow|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79920|NCT01701063|P2|Participant Flow|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79921|NCT01701063|P1|Participant Flow|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
79922|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79923|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79924|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79925|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79926|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79939|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79927|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79928|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79929|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79930|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79931|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79932|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79933|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79934|NCT01701063|O1|Outcome|Overall Participants|Participants aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79935|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79936|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79937|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79938|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79977|NCT01701011|B4|Baseline|Total|Total of all reporting groups
79940|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79941|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79942|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79943|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79944|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79945|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79946|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79947|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79948|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79949|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79950|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79951|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79973|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79952|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79953|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79954|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79955|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79956|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79957|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79958|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79959|NCT01701063|E3|Reported Event|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79960|NCT01701063|E2|Reported Event|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79961|NCT01701063|E1|Reported Event|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
79962|NCT01701024|B3|Baseline|Total|Total of all reporting groups
79963|NCT01701024|B2|Baseline|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79964|NCT01701024|B1|Baseline|ACYC|ACYC active, topically applied to the face for 12 weeks
79965|NCT01701024|P2|Participant Flow|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79966|NCT01701024|P1|Participant Flow|ACYC|ACYC active, topically applied to the face for 12 weeks
79967|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79968|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
79969|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79970|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
79971|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
79972|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
79978|NCT01701011|B3|Baseline|Routine Care Control Group|"Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
79979|NCT01701011|B2|Baseline|Monitoring-control Group|"DRK and Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
79980|NCT01701011|B1|Baseline|PRCI-monitoring Group|"Coping intervention, Daily Record Keeping, Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
79981|NCT01701011|P3|Participant Flow|Routine Care Control Group|Patients receive only questionnaires
79982|NCT01701011|P2|Participant Flow|Monitoring-control Group|Daily Record Keeping and Questionnaires
79983|NCT01701011|P1|Participant Flow|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
79984|NCT01701011|O3|Outcome|Routine Care Control Group|Patients receive only questionnaires
79985|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
79986|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
79987|NCT01701011|O3|Outcome|Routine Care Control Group|patients receive questionnaires
79988|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
79989|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
79990|NCT01701011|E3|Reported Event|Routine Care Control Group|patients received questionnaires
79991|NCT01701011|E2|Reported Event|Monitoring-control Group|Daily Record Keeping and Questionnaires
79992|NCT01701011|E1|Reported Event|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
79993|NCT01700907|B3|Baseline|Total|Total of all reporting groups
79994|NCT01700907|B2|Baseline|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
79995|NCT01700907|B1|Baseline|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
79996|NCT01700907|P2|Participant Flow|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
79997|NCT01700907|P1|Participant Flow|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
79998|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
79999|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80000|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
80001|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80002|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
80003|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80004|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
80005|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80006|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
80007|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80008|NCT01700907|E2|Reported Event|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
80009|NCT01700907|E1|Reported Event|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
80010|NCT01700530|B4|Baseline|Total|Total of all reporting groups
80011|NCT01700530|B3|Baseline|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
80012|NCT01700530|B2|Baseline|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
80013|NCT01700530|B1|Baseline|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
80014|NCT01700530|P3|Participant Flow|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
80015|NCT01700530|P2|Participant Flow|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
80016|NCT01700530|P1|Participant Flow|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
80017|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
80018|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
80019|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
80020|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
80021|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
80022|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
80023|NCT01700530|E3|Reported Event|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
80024|NCT01700530|E2|Reported Event|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
80025|NCT01700530|E1|Reported Event|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
80026|NCT01700517|B4|Baseline|Total|Total of all reporting groups
80027|NCT01700517|B3|Baseline|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80028|NCT01700517|B2|Baseline|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
80029|NCT01700517|B1|Baseline|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80030|NCT01700517|P3|Participant Flow|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80031|NCT01700517|P2|Participant Flow|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
80032|NCT01700517|P1|Participant Flow|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80033|NCT01700517|O3|Outcome|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
80034|NCT01700517|O2|Outcome|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
80035|NCT01700517|O1|Outcome|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
80036|NCT01700517|E3|Reported Event|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80037|NCT01700517|E2|Reported Event|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
80038|NCT01700517|E1|Reported Event|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
80040|NCT01700387|B2|Baseline|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80041|NCT01700387|B1|Baseline|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80042|NCT01700387|P2|Participant Flow|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80043|NCT01700387|P1|Participant Flow|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80044|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80045|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80046|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80047|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80048|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80049|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80214|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
80215|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80050|NCT01700387|E2|Reported Event|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80051|NCT01700387|E1|Reported Event|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
80052|NCT01700348|B1|Baseline|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
80053|NCT01700348|P1|Participant Flow|All Enrolled Subjects|Airflosser & Manual Floss
80054|NCT01700348|O1|Outcome|All Randomized Subjects|"The study was terminated early, data were not analyzed and the plaque samples were destroyed."
80055|NCT01700348|E1|Reported Event|All Randomized Subjects|Summary of AEs for All Randomized Subjects
80056|NCT01700335|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
80057|NCT01700335|P2|Participant Flow|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80058|NCT01700335|P1|Participant Flow|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80059|NCT01700335|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
80060|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80061|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80062|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80063|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80064|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80065|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80066|NCT01700335|E2|Reported Event|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80067|NCT01700335|E1|Reported Event|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
80068|NCT01700179|B1|Baseline|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
80069|NCT01700179|P1|Participant Flow|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.~ACH-0143102~Ribavirin"
80070|NCT01700179|O1|Outcome|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
80071|NCT01700179|E1|Reported Event|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
80072|NCT01700140|B4|Baseline|Total|Total of all reporting groups
80073|NCT01700140|B3|Baseline|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80074|NCT01700140|B2|Baseline|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80216|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80075|NCT01700140|B1|Baseline|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80076|NCT01700140|P3|Participant Flow|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80077|NCT01700140|P2|Participant Flow|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80078|NCT01700140|P1|Participant Flow|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80079|NCT01700140|O3|Outcome|SyB D-0701 25 cm2 Patch|SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.
80080|NCT01700140|O2|Outcome|SyB D-0701 15 cm2 Patch|SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.
80081|NCT01700140|O1|Outcome|Placebo Patch|"Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.~Placebo 25 cm2 patch was applied to subjects in placebo group."
80082|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80083|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80084|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80085|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80086|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80087|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80088|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80089|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80090|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80091|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80092|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80093|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80094|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80095|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80096|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80097|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80098|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80099|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80100|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80101|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80102|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80103|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80104|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80105|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80106|NCT01700140|E3|Reported Event|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80107|NCT01700140|E2|Reported Event|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80108|NCT01700140|E1|Reported Event|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
80109|NCT01699867|B1|Baseline|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
80110|NCT01699867|P1|Participant Flow|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
80111|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
80112|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
80113|NCT01699867|E1|Reported Event|All Patients (Single-arm)|All enrolled study patients.
80114|NCT01699815|B3|Baseline|Total|Total of all reporting groups
80115|NCT01699815|B2|Baseline|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80116|NCT01699815|B1|Baseline|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
80117|NCT01699815|P2|Participant Flow|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80118|NCT01699815|P1|Participant Flow|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
80119|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80217|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80218|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80120|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
80121|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80122|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
80123|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80124|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
80125|NCT01699815|E2|Reported Event|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
80126|NCT01699815|E1|Reported Event|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.~Acetaminophen"
80127|NCT01699789|B3|Baseline|Total|Total of all reporting groups
80128|NCT01699789|B2|Baseline|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80129|NCT01699789|B1|Baseline|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80130|NCT01699789|P2|Participant Flow|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.~QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~CEP Council: The CEP Council was supported by a workbook de"
80131|NCT01699789|P1|Participant Flow|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.~QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
80132|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80219|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80220|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80221|NCT01699750|E2|Reported Event|ACUVUE OASYS With HYDRACLEAR|Senofilcon A contact lenses worn for 60 days, replaced biweekly
80133|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80134|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80135|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80136|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80137|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80138|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80139|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80222|NCT01699750|E1|Reported Event|AIR OPTIX AQUA|Lotrafilcon B contact lenses worn for 60 days, replaced monthly
80223|NCT01699698|B3|Baseline|Total|Total of all reporting groups
80224|NCT01699698|B2|Baseline|Control|Normal cohort
80225|NCT01699698|B1|Baseline|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
80226|NCT01699698|P2|Participant Flow|Control|Normal cohort
80140|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80141|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80142|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80143|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80144|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80145|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80146|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80227|NCT01699698|P1|Participant Flow|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
80228|NCT01699698|O2|Outcome|Control|Normal cohort
80229|NCT01699698|O1|Outcome|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
80230|NCT01699698|O2|Outcome|Control|Normal cohort
80231|NCT01699698|O1|Outcome|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
80147|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80148|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80149|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80150|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80151|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80152|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80153|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80232|NCT01699698|E2|Reported Event|Normal|Normal cohort
80233|NCT01699698|E1|Reported Event|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
80234|NCT01699685|B3|Baseline|Total|Total of all reporting groups
80235|NCT01699685|B2|Baseline|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80154|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80155|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80156|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80157|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80158|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80159|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80160|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80236|NCT01699685|B1|Baseline|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80237|NCT01699685|P2|Participant Flow|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80238|NCT01699685|P1|Participant Flow|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80161|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80162|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80163|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80164|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80165|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80166|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80167|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80239|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80240|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80241|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80168|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80169|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80170|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80171|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80172|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80173|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80174|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80242|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80243|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80244|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80175|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80176|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80177|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80178|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80179|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80180|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80181|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80245|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80246|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80247|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80182|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80183|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80184|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80185|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80186|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80187|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80188|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80248|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80249|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80250|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80189|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80190|NCT01699789|E2|Reported Event|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
80191|NCT01699789|E1|Reported Event|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
80192|NCT01699763|B1|Baseline|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80193|NCT01699763|P1|Participant Flow|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80194|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80195|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80196|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80197|NCT01699763|E1|Reported Event|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
80198|NCT01699750|B3|Baseline|Total|Total of all reporting groups
80199|NCT01699750|B2|Baseline|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80200|NCT01699750|B1|Baseline|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80201|NCT01699750|P2|Participant Flow|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80202|NCT01699750|P1|Participant Flow|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80203|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80204|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80205|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
80206|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
80207|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
80208|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
80209|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
80210|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
80211|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
80212|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
80213|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
80251|NCT01699685|E2|Reported Event|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
80252|NCT01699685|E1|Reported Event|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
80253|NCT01699607|B3|Baseline|Total|Total of all reporting groups
80254|NCT01699607|B2|Baseline|Nonsmoker Subjects|Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
80255|NCT01699607|B1|Baseline|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
80256|NCT01699607|P2|Participant Flow|Nonsmoking Subjects|Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
80257|NCT01699607|P1|Participant Flow|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
80258|NCT01699607|O2|Outcome|Nonsmoking Subjects|Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
80259|NCT01699607|O1|Outcome|Smoking Subjects|Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.
80260|NCT01699607|E1|Reported Event|Amphetamine|"There is only one arm to the study. All subjects will receive amphetamine.~Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain."
80261|NCT01699373|B3|Baseline|Total|Total of all reporting groups
80262|NCT01699373|B2|Baseline|Manual Palpation|
80263|NCT01699373|B1|Baseline|Ultrasound-assisted|Pre-procedural ultrasound scan performed
80264|NCT01699373|P2|Participant Flow|Manual Palpation|
80265|NCT01699373|P1|Participant Flow|Ultrasound-assisted|Pre-procedural ultrasound scan performed
80266|NCT01699373|O2|Outcome|Manual Palpation|
80267|NCT01699373|O1|Outcome|Ultrasound-assisted|Pre-procedural ultrasound scan performed
80268|NCT01699373|E2|Reported Event|Manual Palpation|
80269|NCT01699373|E1|Reported Event|Ultrasound-assisted|Pre-procedural ultrasound scan performed
80270|NCT01699022|B1|Baseline|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
80271|NCT01699022|P1|Participant Flow|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
80272|NCT01699022|O1|Outcome|Cyclofem|
80273|NCT01699022|O1|Outcome|Cyclofem|
80274|NCT01699022|O1|Outcome|Cyclofem|
80275|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
80276|NCT01699022|O1|Outcome|Cyclofem|
80277|NCT01699022|O1|Outcome|Cyclofem|
80278|NCT01699022|O1|Outcome|Cyclofem|
80279|NCT01699022|O1|Outcome|Cyclofem|
80280|NCT01699022|O1|Outcome|Cyclofem|
80281|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
80282|NCT01699022|E1|Reported Event|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
80283|NCT01698814|B3|Baseline|Total|Total of all reporting groups
80284|NCT01698814|B2|Baseline|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
80285|NCT01698814|B1|Baseline|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
80286|NCT01698814|P2|Participant Flow|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
80287|NCT01698814|P1|Participant Flow|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
80288|NCT01698814|O2|Outcome|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
80289|NCT01698814|O1|Outcome|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
80290|NCT01698814|E2|Reported Event|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
80291|NCT01698814|E1|Reported Event|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
80292|NCT01698801|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
81350|NCT01691534|P5|Participant Flow|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
80293|NCT01698801|P1|Participant Flow|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80294|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80295|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80296|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80297|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80298|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
80299|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason."
80300|NCT01698801|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle~Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle"
80301|NCT01698684|B4|Baseline|Total|Total of all reporting groups
80302|NCT01698684|B3|Baseline|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
80303|NCT01698684|B2|Baseline|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
80304|NCT01698684|B1|Baseline|Placebo|Placebo: One dose 15 minutes before attempting intercourse
80305|NCT01698684|P3|Participant Flow|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
80306|NCT01698684|P2|Participant Flow|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
80307|NCT01698684|P1|Participant Flow|Placebo|Placebo: One dose 15 minutes before attempting intercourse
80308|NCT01698684|O3|Outcome|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
80309|NCT01698684|O2|Outcome|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
80310|NCT01698684|O1|Outcome|Placebo|Placebo: One dose 15 minutes before attempting intercourse
80311|NCT01698684|E3|Reported Event|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
80312|NCT01698684|E2|Reported Event|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
80313|NCT01698684|E1|Reported Event|Placebo|Placebo: One dose 15 minutes before attempting intercourse
80314|NCT01698554|B5|Baseline|Total|Total of all reporting groups
80315|NCT01698554|B4|Baseline|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80316|NCT01698554|B3|Baseline|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80317|NCT01698554|B2|Baseline|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80318|NCT01698554|B1|Baseline|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80319|NCT01698554|P4|Participant Flow|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80320|NCT01698554|P3|Participant Flow|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80321|NCT01698554|P2|Participant Flow|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80322|NCT01698554|P1|Participant Flow|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80323|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80324|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80325|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80326|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80407|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80327|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80328|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80329|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80330|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80331|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80332|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80333|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80334|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80335|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80336|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80337|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80338|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80339|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80340|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80341|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80342|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80343|NCT01698554|E4|Reported Event|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80344|NCT01698554|E3|Reported Event|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80345|NCT01698554|E2|Reported Event|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80346|NCT01698554|E1|Reported Event|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
80347|NCT01698502|B3|Baseline|Total|Total of all reporting groups
80348|NCT01698502|B2|Baseline|Untrained|Healthy, sedentary (Maximal oxygen uptake (VO2max), ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
80349|NCT01698502|B1|Baseline|Trained|Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
80350|NCT01698502|P2|Participant Flow|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
80351|NCT01698502|P1|Participant Flow|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
80352|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
80353|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
80354|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
80355|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
80356|NCT01698502|E2|Reported Event|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
80357|NCT01698502|E1|Reported Event|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
80358|NCT01698320|B3|Baseline|Total|Total of all reporting groups
80359|NCT01698320|B2|Baseline|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80360|NCT01698320|B1|Baseline|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80361|NCT01698320|P3|Participant Flow|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80362|NCT01698320|P2|Participant Flow|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80363|NCT01698320|P1|Participant Flow|All Enrolled Subjects|Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
80364|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80365|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80366|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80367|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80368|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80369|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80370|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80371|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80372|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80373|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80408|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
80409|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80410|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
81544|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
80374|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80375|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
80376|NCT01698320|E4|Reported Event|Albuterol MDPI (Formerly Albuterol) - Open Label Period|After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
80377|NCT01698320|E3|Reported Event|Albuterol MDPI (Formerly Placebo) - Open Label Period|After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
80378|NCT01698320|E2|Reported Event|Placebo MDPI - Double-blind Period|Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
80379|NCT01698320|E1|Reported Event|Albuterol MDPI - Double-blind Period|Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
80380|NCT01697969|B1|Baseline|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
80381|NCT01697969|P1|Participant Flow|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
80382|NCT01697969|O2|Outcome|Right Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
80383|NCT01697969|O1|Outcome|Left Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
80384|NCT01697969|E1|Reported Event|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
80385|NCT01697956|B3|Baseline|Total|Total of all reporting groups
80386|NCT01697956|B2|Baseline|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80387|NCT01697956|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80388|NCT01697956|P2|Participant Flow|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80389|NCT01697956|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80390|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80391|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80392|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80393|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80394|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80395|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80396|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80397|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80398|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80399|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80400|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
80401|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80402|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
80403|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80404|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
80405|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80406|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
80411|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
80412|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80413|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80414|NCT01697956|E2|Reported Event|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
80415|NCT01697956|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
80416|NCT01697696|B3|Baseline|Total|Total of all reporting groups
80417|NCT01697696|B2|Baseline|QAB149|75 μg once-daily
80418|NCT01697696|B1|Baseline|NVA237|12.5 μg twice-daily
80419|NCT01697696|P2|Participant Flow|QAB149|75 μg once-daily
80420|NCT01697696|P1|Participant Flow|NVA237|12.5 μg twice-daily
80421|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80422|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80423|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80424|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80425|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80426|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80427|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80428|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80429|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80430|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80431|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80432|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80433|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80434|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80435|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80436|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80437|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
80438|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
80439|NCT01697696|E2|Reported Event|QAB149|75 μg once-daily
80440|NCT01697696|E1|Reported Event|NVA237|12.5 μg twice-daily
80441|NCT01697592|B11|Baseline|Total|Total of all reporting groups
80442|NCT01697592|B10|Baseline|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80443|NCT01697592|B9|Baseline|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80444|NCT01697592|B8|Baseline|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
80445|NCT01697592|B7|Baseline|Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80446|NCT01697592|B6|Baseline|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
80447|NCT01697592|B5|Baseline|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80448|NCT01697592|B4|Baseline|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
80449|NCT01697592|B3|Baseline|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
80450|NCT01697592|B2|Baseline|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
80451|NCT01697592|B1|Baseline|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
80452|NCT01697592|P10|Participant Flow|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80453|NCT01697592|P9|Participant Flow|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80454|NCT01697592|P8|Participant Flow|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
80455|NCT01697592|P7|Participant Flow|Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80456|NCT01697592|P6|Participant Flow|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
80457|NCT01697592|P5|Participant Flow|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
80458|NCT01697592|P4|Participant Flow|Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
80459|NCT01697592|P3|Participant Flow|Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
80460|NCT01697592|P2|Participant Flow|Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
80461|NCT01697592|P1|Participant Flow|Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
80462|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80463|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80464|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80465|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
80466|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80467|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80468|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80469|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80470|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80471|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80472|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80473|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80474|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.
80475|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
80476|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
80477|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80478|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
80479|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
80480|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80481|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
80482|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80483|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80484|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80485|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80486|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80487|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80488|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80489|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80490|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80491|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80492|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80493|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80494|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.
80495|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
80496|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
80497|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80498|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
80499|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
80500|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
80501|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
80502|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80503|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80504|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80505|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80506|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80507|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80508|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80509|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80510|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80511|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80512|NCT01697592|E12|Reported Event|Omarigliptin 25mg/ABM (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued any prestudy basal medications throughout the duration of the study."
80513|NCT01697592|E11|Reported Event|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80514|NCT01697592|E10|Reported Event|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
80515|NCT01697592|E9|Reported Event|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
80516|NCT01697592|E8|Reported Event|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
80517|NCT01697592|E7|Reported Event|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
80518|NCT01697592|E6|Reported Event|Placebo/ABM (Phase A)|Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
80519|NCT01697592|E5|Reported Event|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
80520|NCT01697592|E4|Reported Event|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
80521|NCT01697592|E3|Reported Event|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
80522|NCT01697592|E2|Reported Event|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
80523|NCT01697592|E1|Reported Event|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
80524|NCT01697501|B1|Baseline|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
80525|NCT01697501|P1|Participant Flow|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
80526|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
80527|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
80528|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
80529|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
80530|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
80531|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
80532|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
80533|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
80534|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
80535|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
80536|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
80537|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
80538|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
80539|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
80540|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
80541|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
80542|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
80543|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
80544|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
80545|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
80546|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
80547|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
80548|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
80549|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
80550|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
80551|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
80552|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
80553|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
80554|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
80555|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
80556|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
80557|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
80558|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
80559|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
80560|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
80561|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
80562|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
80563|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
80564|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
80565|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
80566|NCT01697501|E1|Reported Event|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
81545|NCT01691248|E2|Reported Event|Placebo|Placebo tablet once daily for no longer than 40 days
80567|NCT01697462|B1|Baseline|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80568|NCT01697462|P1|Participant Flow|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80569|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80570|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80571|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80572|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80573|NCT01697462|E1|Reported Event|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
80574|NCT01697449|B1|Baseline|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80575|NCT01697449|P1|Participant Flow|Colorectal Cancer (CRC) Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80576|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80577|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80578|NCT01697449|O1|Outcome|Unresectable|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
80579|NCT01697449|O2|Outcome|Unresectable CRC at Baseline|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
80580|NCT01697449|O1|Outcome|Resectable/Potentially Resectable CRC at Baseline|Participants with resectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
80581|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80582|NCT01697449|E1|Reported Event|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
80583|NCT01697345|B1|Baseline|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
80584|NCT01697345|P1|Participant Flow|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
80585|NCT01697345|O2|Outcome|Did Not Continue Vaginal Testosterone Therapy|Participants who chose not to continue vaginal testosterone upon completion of the study.
80586|NCT01697345|O1|Outcome|Continued Vaginal Testosterone Therapy|Participants who chose to continue vaginal testosterone therapy upon completion of the study.
80587|NCT01697345|O2|Outcome|FSFI Pain Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80588|NCT01697345|O1|Outcome|FSFI Pain Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80615|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
82007|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
80589|NCT01697345|O2|Outcome|FSFI Satisfaction Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80590|NCT01697345|O1|Outcome|FSFI Satisfaction Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80591|NCT01697345|O2|Outcome|FSFI Orgasm Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80592|NCT01697345|O1|Outcome|FSFI Orgasm Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80593|NCT01697345|O2|Outcome|FSFI Lubrication Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80594|NCT01697345|O1|Outcome|FSFI Lubrication Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80595|NCT01697345|O2|Outcome|FSFI Arousal Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80596|NCT01697345|O1|Outcome|FSFI Arousal Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80597|NCT01697345|O2|Outcome|FSFI Desire Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80598|NCT01697345|O1|Outcome|FSFI Desire Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80599|NCT01697345|O2|Outcome|FSFI Total Score (Postteset)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
80600|NCT01697345|O1|Outcome|FSFI Total Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
80601|NCT01697345|E1|Reported Event|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
80602|NCT01697319|B1|Baseline|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80603|NCT01697319|P1|Participant Flow|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80604|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80605|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80606|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80607|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80608|NCT01697319|E1|Reported Event|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
80609|NCT01696994|B3|Baseline|Total|Total of all reporting groups
80610|NCT01696994|B2|Baseline|Ovarian Screening|Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80611|NCT01696994|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80612|NCT01696994|P2|Participant Flow|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80613|NCT01696994|P1|Participant Flow|Control|Participants receive standard medical care.
80614|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
82008|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
80616|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80617|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80618|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80619|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80620|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80621|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80622|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80623|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80624|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80625|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80626|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80627|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80628|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80629|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80630|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80631|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80632|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80633|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80634|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80635|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80636|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
80637|NCT01696994|E1|Reported Event|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
80638|NCT01696981|B3|Baseline|Total|Total of all reporting groups
80639|NCT01696981|B2|Baseline|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80640|NCT01696981|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80641|NCT01696981|P2|Participant Flow|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80642|NCT01696981|P1|Participant Flow|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80643|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80665|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
82009|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
80644|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80645|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80646|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80647|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80648|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80649|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80650|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80651|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80652|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80653|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80654|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80655|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80656|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80657|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
80658|NCT01696981|E1|Reported Event|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
80659|NCT01696968|B3|Baseline|Total|Total of all reporting groups
80660|NCT01696968|B2|Baseline|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80661|NCT01696968|B1|Baseline|Control|Participants receive standard medical care.
80662|NCT01696968|P2|Participant Flow|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80663|NCT01696968|P1|Participant Flow|Control|Participants receive standard medical care.
80664|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80666|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80667|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80668|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80669|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80670|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80671|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80672|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80673|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80674|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80675|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80676|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80677|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80678|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80679|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80680|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
80681|NCT01696968|E1|Reported Event|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
80682|NCT01696929|B1|Baseline|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
80683|NCT01696929|P1|Participant Flow|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacological Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
80684|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
80685|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
80686|NCT01696929|E1|Reported Event|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
80687|NCT01696773|B3|Baseline|Total|Total of all reporting groups
80688|NCT01696773|B2|Baseline|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
80689|NCT01696773|B1|Baseline|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
80690|NCT01696773|P2|Participant Flow|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
80691|NCT01696773|P1|Participant Flow|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
80692|NCT01696773|O2|Outcome|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
80693|NCT01696773|O1|Outcome|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
80694|NCT01696773|E2|Reported Event|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
81546|NCT01691248|E1|Reported Event|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
80695|NCT01696773|E1|Reported Event|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
80696|NCT01696760|B3|Baseline|Total|Total of all reporting groups
80697|NCT01696760|B2|Baseline|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80698|NCT01696760|B1|Baseline|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80699|NCT01696760|P2|Participant Flow|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80700|NCT01696760|P1|Participant Flow|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80701|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80702|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80703|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80704|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80705|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80706|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80707|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80708|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80709|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80710|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80711|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80712|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80713|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80714|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80842|NCT01695772|B1|Baseline|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80715|NCT01696760|E2|Reported Event|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80716|NCT01696760|E1|Reported Event|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
80717|NCT01696695|B1|Baseline|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80718|NCT01696695|P1|Participant Flow|Metastatic Colorectal Carcinoma (mCRC) Participants|Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80719|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80720|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80721|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80722|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80723|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80724|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80725|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80726|NCT01696695|E1|Reported Event|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
80727|NCT01696643|B3|Baseline|Total|Total of all reporting groups
80728|NCT01696643|B2|Baseline|Placebo|Placebo, administered orally, BID for 52 weeks
80729|NCT01696643|B1|Baseline|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80730|NCT01696643|P2|Participant Flow|Placebo|Placebo, administered orally, BID for 52 weeks
80731|NCT01696643|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
80732|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
80733|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80734|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80735|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
80736|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80737|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
80738|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80739|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
80740|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80741|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
80742|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80743|NCT01696643|E2|Reported Event|Placebo|Placebo, administered orally, BID for 52 weeks
80744|NCT01696643|E1|Reported Event|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
80745|NCT01696357|B3|Baseline|Total|Total of all reporting groups
81547|NCT01691014|B5|Baseline|Total|Total of all reporting groups
80746|NCT01696357|B2|Baseline|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80747|NCT01696357|B1|Baseline|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80748|NCT01696357|P2|Participant Flow|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80749|NCT01696357|P1|Participant Flow|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80750|NCT01696357|O2|Outcome|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80751|NCT01696357|O1|Outcome|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80752|NCT01696357|E2|Reported Event|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80753|NCT01696357|E1|Reported Event|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
80754|NCT01696214|B5|Baseline|Total|Total of all reporting groups
80755|NCT01696214|B4|Baseline|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
80756|NCT01696214|B3|Baseline|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
80757|NCT01696214|B2|Baseline|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
80758|NCT01696214|B1|Baseline|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
80759|NCT01696214|P4|Participant Flow|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
81058|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
80760|NCT01696214|P3|Participant Flow|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
80761|NCT01696214|P2|Participant Flow|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
80762|NCT01696214|P1|Participant Flow|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
80763|NCT01696214|O4|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
80764|NCT01696214|O3|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.~Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks."
80765|NCT01696214|O2|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.~Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks"
80766|NCT01696214|O1|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.~ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
80767|NCT01696214|E4|Reported Event|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
80768|NCT01696214|E3|Reported Event|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
80769|NCT01696214|E2|Reported Event|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
80770|NCT01696214|E1|Reported Event|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
80771|NCT01696188|B3|Baseline|Total|Total of all reporting groups
80772|NCT01696188|B2|Baseline|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plan approach.~interscalene nerve catheter"
80773|NCT01696188|B1|Baseline|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80774|NCT01696188|P2|Participant Flow|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80775|NCT01696188|P1|Participant Flow|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80776|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80777|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80778|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80779|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80780|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80781|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80782|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80783|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80784|NCT01696188|E2|Reported Event|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
80785|NCT01696188|E1|Reported Event|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
80786|NCT01696071|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
80787|NCT01696071|P2|Participant Flow|Tio R5 QD / Tio R2.5 BID|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg) Treatment 2: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg)"
81662|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
80788|NCT01696071|P1|Participant Flow|Tio R2.5 Twice Daily (BID) / Tio R5 Once Daily (QD)|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg) Treatment 2: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg)"
80789|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80790|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80791|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80792|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80793|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80794|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80795|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80796|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80797|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80798|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80799|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80800|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80801|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80802|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80803|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80804|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80805|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80806|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80807|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80808|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80809|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80810|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with inhaled corticosteroid (iCS).
80811|NCT01696071|E2|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80812|NCT01696071|E1|Reported Event|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
80813|NCT01696058|B3|Baseline|Total|Total of all reporting groups
80814|NCT01696058|B2|Baseline|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80815|NCT01696058|B1|Baseline|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
80816|NCT01696058|P2|Participant Flow|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80817|NCT01696058|P1|Participant Flow|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
80818|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80819|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81486|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
80820|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80821|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80822|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80823|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80824|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80825|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80826|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80827|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80828|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80829|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80830|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80831|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80832|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80833|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80834|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80835|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80836|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80837|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80838|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80839|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80840|NCT01696058|E2|Reported Event|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80841|NCT01696058|E1|Reported Event|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80843|NCT01695772|P1|Participant Flow|Bevacizumab|Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80844|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80845|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80846|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80847|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80848|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80849|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80850|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80851|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80852|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80853|NCT01695772|E1|Reported Event|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
80854|NCT01695746|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80855|NCT01695746|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80856|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80857|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80858|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80859|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80860|NCT01695746|O1|Outcome|C.E.R.A (Continuous Erythropoietin Receptor Activator)|Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80861|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80862|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80863|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80864|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80865|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80866|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80867|NCT01695746|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
80868|NCT01695668|B3|Baseline|Total|Total of all reporting groups
80869|NCT01695668|B2|Baseline|Restasis|Cyclosporine
80870|NCT01695668|B1|Baseline|Lotemax|Loteprednol Etabonate 0.5%
80871|NCT01695668|P2|Participant Flow|Restasis|Cyclosporine
80872|NCT01695668|P1|Participant Flow|Lotemax|Loteprednol Etabonate 0.5%
80873|NCT01695668|O2|Outcome|Restasis|Cyclosporine
80874|NCT01695668|O1|Outcome|Lotemax|Loteprednol Etabonate 0.5%
80875|NCT01695668|E2|Reported Event|Restasis|"Cyclosporine~Restasis"
80876|NCT01695668|E1|Reported Event|Lotemax|"Loteprednol Etabonate 0.5%~Lotemax"
80877|NCT01695369|B1|Baseline|Overall Study Participants|Senofilcon A and Comfilcon A
80878|NCT01695369|P1|Participant Flow|Overall Study Participants|Senofilcon A and Comfilcon A
80879|NCT01695369|O2|Outcome|Senofilcon A|Senofilcon A (Vistakon Acuvue® Oasys)
80880|NCT01695369|O1|Outcome|Comfilcon A|comfilcon A (CooperVision Biofinity®Sphere)
80881|NCT01695369|E2|Reported Event|Comfilcon A|Comfilcon A / CooperVision Biofinity Sphere
80882|NCT01695369|E1|Reported Event|Overall Study Participants|Senofilcon A and Comfilcon A
80883|NCT01695330|B1|Baseline|Subcutaneous Bortezomib|
80884|NCT01695330|P2|Participant Flow||This is one-arm study.
81059|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
80885|NCT01695330|P1|Participant Flow|Subcutaneous Bortezomib|patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
80886|NCT01695330|O1|Outcome|Subcutaneous Bortezomib|Patients with MM who received treatment with a SC bortezomib-containing combination
80887|NCT01695330|E1|Reported Event|Subcutaneous Bortezomib|Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
80888|NCT01695239|B5|Baseline|Total|Total of all reporting groups
80889|NCT01695239|B4|Baseline|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80890|NCT01695239|B3|Baseline|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80891|NCT01695239|B2|Baseline|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80892|NCT01695239|B1|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80893|NCT01695239|P4|Participant Flow|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80894|NCT01695239|P3|Participant Flow|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80895|NCT01695239|P2|Participant Flow|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80896|NCT01695239|P1|Participant Flow|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
80897|NCT01695239|O3|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80898|NCT01695239|O2|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80899|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80900|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80901|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80902|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80903|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80904|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80905|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80906|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80907|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80908|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80909|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80910|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80911|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80912|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80913|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80914|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80915|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80916|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80917|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80918|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80919|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80920|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80921|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80922|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80923|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80924|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80925|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80926|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80927|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80928|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80929|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80930|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80931|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80932|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80933|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80934|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80935|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80936|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80937|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80938|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80939|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80940|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80941|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80942|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80943|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80944|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80945|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80946|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80947|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80948|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80949|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80950|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80951|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80952|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80953|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80954|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80955|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80956|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80957|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80958|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80959|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80960|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80961|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80962|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80963|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80964|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80965|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80966|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80967|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80968|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80969|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80970|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80971|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80972|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80973|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80974|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80975|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80976|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80977|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80978|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80979|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80980|NCT01695239|E4|Reported Event|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80981|NCT01695239|E3|Reported Event|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
80982|NCT01695239|E2|Reported Event|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
80983|NCT01695239|E1|Reported Event|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
80984|NCT01694771|B3|Baseline|Total|Total of all reporting groups
80985|NCT01694771|B2|Baseline|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80986|NCT01694771|B1|Baseline|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
81060|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
80987|NCT01694771|P2|Participant Flow|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80988|NCT01694771|P1|Participant Flow|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
80989|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80990|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80991|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80992|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80993|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80994|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80995|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80996|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80997|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
80998|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
80999|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81000|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81001|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81002|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81003|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81004|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81005|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81006|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81007|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81008|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
82920|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
81009|NCT01694771|E2|Reported Event|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
81010|NCT01694771|E1|Reported Event|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
81011|NCT01694706|B1|Baseline|Entire Study Population|"All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Drug administrations were separated by a washout period of at least 14 days"
81012|NCT01694706|P3|Participant Flow|Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir|"Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration"
81013|NCT01694706|P2|Participant Flow|Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP|"Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir."
81014|NCT01694706|P1|Participant Flow|Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed|"Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.~Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less."
81015|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
81016|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
81017|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
81018|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
81019|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
81020|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
81021|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
81022|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
81023|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
81024|NCT01694706|E4|Reported Event|Omeprazole|40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
81025|NCT01694706|E3|Reported Event|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast
81487|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81026|NCT01694706|E2|Reported Event|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
81027|NCT01694706|E1|Reported Event|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
81028|NCT01694667|B3|Baseline|Total|Total of all reporting groups
81029|NCT01694667|B2|Baseline|Placebo|Participants randomized to placebo
81030|NCT01694667|B1|Baseline|Omega-3|Participants randomized to omega-3
81031|NCT01694667|P2|Participant Flow|Placebo|"Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~28 participants allocated to this group."
81032|NCT01694667|P1|Participant Flow|Omega-3 Fatty Acids|"Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~29 participants allocated to this group."
81033|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81034|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81035|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81036|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81037|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81038|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81039|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81040|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81041|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81042|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81043|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
81044|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
81045|NCT01694667|E2|Reported Event|Placebo|Participants randomized to placebo
81046|NCT01694667|E1|Reported Event|Omega-3|Participants randomized to omega-3
81047|NCT01694641|B3|Baseline|Total|Total of all reporting groups
81048|NCT01694641|B2|Baseline|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
81049|NCT01694641|B1|Baseline|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
81050|NCT01694641|P2|Participant Flow|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
81051|NCT01694641|P1|Participant Flow|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
81052|NCT01694641|O2|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
81053|NCT01694641|O1|Outcome|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
81054|NCT01694641|E2|Reported Event|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
81055|NCT01694641|E1|Reported Event|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
81056|NCT01694420|B1|Baseline|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81057|NCT01694420|P1|Participant Flow|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81061|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81062|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81063|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81064|NCT01694420|E1|Reported Event|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
81065|NCT01694108|B3|Baseline|Total|Total of all reporting groups
81066|NCT01694108|B2|Baseline|Control Children|No intervention
81067|NCT01694108|B1|Baseline|BCG-vaccine|SSI strain 1331 standard dose
81068|NCT01694108|P2|Participant Flow|Control Children (no Intervention)|
81069|NCT01694108|P1|Participant Flow|BCG-vaccine|
81070|NCT01694108|O2|Outcome|Face-to-face|Randomized to receive information about the study by standard face-to-face consultation.
81071|NCT01694108|O1|Outcome|Telephone|Randomized to receive information about the study by telephone
81072|NCT01694108|O2|Outcome|Declining Mothers|Mothers who decided not to let their child participate in the study
81073|NCT01694108|O1|Outcome|Participating Mothers|Mothers who decided to let their child participate in the study
81074|NCT01694108|O2|Outcome|Control Children|No intervention
81075|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81076|NCT01694108|O2|Outcome|Control Children|No intervention
81077|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81078|NCT01694108|O2|Outcome|Control Children|No intervention
81079|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81080|NCT01694108|O2|Outcome|Control Children|No intervention
81081|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81082|NCT01694108|O2|Outcome|Control Children|No intervention
81083|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81084|NCT01694108|O2|Outcome|Control Children|No intervention
81085|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81086|NCT01694108|O2|Outcome|Control Children|No intervention
81087|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81088|NCT01694108|O2|Outcome|Control Children|No intervention
81089|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81090|NCT01694108|O2|Outcome|Control Children|No intervention
81091|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81092|NCT01694108|O2|Outcome|Control Children|No intervention
81093|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81094|NCT01694108|O2|Outcome|Control Children|No intervention
81095|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81096|NCT01694108|O2|Outcome|Control Children|No intervention
81097|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81098|NCT01694108|O2|Outcome|Control Children|No intervention
81099|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81100|NCT01694108|O2|Outcome|Control Children|No intervention
81101|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81102|NCT01694108|O2|Outcome|Control Children|No intervention
81103|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81104|NCT01694108|O2|Outcome|Control Children|No intervention
81105|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81106|NCT01694108|O2|Outcome|Control Children|No intervention
81107|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81108|NCT01694108|O2|Outcome|Control Children|No intervention
81109|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81110|NCT01694108|O2|Outcome|Control Children|No intervention
81111|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81112|NCT01694108|O2|Outcome|Control Children|No intervention
81113|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81114|NCT01694108|O2|Outcome|Control Children|No intervention
81115|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
81116|NCT01694108|O2|Outcome|Control Children|No intervention
81117|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
81118|NCT01694108|O2|Outcome|Control Children (no Intervention)|
81119|NCT01694108|O1|Outcome|BCG-vaccine|
81120|NCT01694108|E2|Reported Event|Control Children (no Intervention)|
81121|NCT01694108|E1|Reported Event|BCG-vaccine|
81122|NCT01693653|B3|Baseline|Total|Total of all reporting groups
81123|NCT01693653|B2|Baseline|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81124|NCT01693653|B1|Baseline|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81125|NCT01693653|P2|Participant Flow|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81126|NCT01693653|P1|Participant Flow|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81127|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81128|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81129|NCT01693653|E2|Reported Event|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81130|NCT01693653|E1|Reported Event|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
81131|NCT01693367|B3|Baseline|Total|Total of all reporting groups
81132|NCT01693367|B2|Baseline|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81133|NCT01693367|B1|Baseline|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81134|NCT01693367|P2|Participant Flow|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81135|NCT01693367|P1|Participant Flow|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81136|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81137|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81138|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81139|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81140|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81141|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81142|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81143|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81144|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81145|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81146|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81147|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81148|NCT01693367|E2|Reported Event|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
81149|NCT01693367|E1|Reported Event|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
81150|NCT01693185|B3|Baseline|Total|Total of all reporting groups
81151|NCT01693185|B2|Baseline|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81152|NCT01693185|B1|Baseline|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81153|NCT01693185|P2|Participant Flow|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81154|NCT01693185|P1|Participant Flow|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81155|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81156|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81157|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81197|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81158|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81159|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81160|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81161|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81162|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81163|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81164|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81165|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81166|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81167|NCT01693185|E2|Reported Event|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
81168|NCT01693185|E1|Reported Event|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
81169|NCT01692938|B3|Baseline|Total|Total of all reporting groups
81170|NCT01692938|B2|Baseline|Retinal Disease|
81171|NCT01692938|B1|Baseline|No Retinal Disease|
81172|NCT01692938|P2|Participant Flow|Retinal Disease|
81173|NCT01692938|P1|Participant Flow|No Retinal Disease|
81174|NCT01692938|O2|Outcome|Retinal Disease|
81175|NCT01692938|O1|Outcome|No Retinal Disease|
81176|NCT01692938|O2|Outcome|Retinal Disease|
81177|NCT01692938|O1|Outcome|No Retinal Disease|
81178|NCT01692938|E2|Reported Event|Retinal Disease|
81179|NCT01692938|E1|Reported Event|No Retinal Disease|
81180|NCT01692782|B4|Baseline|Total|Total of all reporting groups
81181|NCT01692782|B3|Baseline|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81182|NCT01692782|B2|Baseline|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 8mg once daily"
81183|NCT01692782|B1|Baseline|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily"
81184|NCT01692782|P3|Participant Flow|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81185|NCT01692782|P2|Participant Flow|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81186|NCT01692782|P1|Participant Flow|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81187|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81188|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81189|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81190|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81191|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81192|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81193|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81194|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81195|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81196|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81738|NCT01689857|E1|Reported Event|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
81198|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81199|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81200|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81201|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81202|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81203|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81204|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81205|NCT01692782|E3|Reported Event|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
81206|NCT01692782|E2|Reported Event|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81207|NCT01692782|E1|Reported Event|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
81208|NCT01692691|B1|Baseline|Number of Participants|Dacarbazine Carmustine
81209|NCT01692691|P1|Participant Flow|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
81210|NCT01692691|O1|Outcome|Response Rate|Dacarbazine Carmustine
81211|NCT01692691|O1|Outcome|Progression Free Survival at 8 Weeks|Dacarbazine + Carmustine
81212|NCT01692691|E1|Reported Event|Number of Participants|Dacarbazine Carmustine
81213|NCT01692340|B4|Baseline|Total|Total of all reporting groups
81214|NCT01692340|B3|Baseline|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81215|NCT01692340|B2|Baseline|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81216|NCT01692340|B1|Baseline|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81217|NCT01692340|P3|Participant Flow|Istotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81218|NCT01692340|P2|Participant Flow|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81219|NCT01692340|P1|Participant Flow|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81220|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81221|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81222|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81223|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81224|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81225|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81226|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81227|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81228|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81229|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81230|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81231|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81232|NCT01692340|E3|Reported Event|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81488|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81233|NCT01692340|E2|Reported Event|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81234|NCT01692340|E1|Reported Event|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
81235|NCT01692301|B3|Baseline|Total|Total of all reporting groups
81236|NCT01692301|B2|Baseline|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81237|NCT01692301|B1|Baseline|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81238|NCT01692301|P2|Participant Flow|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81239|NCT01692301|P1|Participant Flow|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81240|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81241|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81242|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81243|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81244|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81245|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81246|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81247|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81489|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81248|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81249|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81250|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81251|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81252|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81253|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81254|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81255|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81256|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81257|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81258|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81259|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81260|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81306|NCT01691560|B2|Baseline|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81261|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81262|NCT01692301|E2|Reported Event|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
81263|NCT01692301|E1|Reported Event|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
81264|NCT01691885|B1|Baseline|Per Protocol Population|All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
81265|NCT01691885|P2|Participant Flow|FF/VI Then Placebo|Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
81266|NCT01691885|P1|Participant Flow|Placebo Then FF/VI|Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
81267|NCT01691885|O2|Outcome|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
81268|NCT01691885|O1|Outcome|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
81269|NCT01691885|E2|Reported Event|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
81270|NCT01691885|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
81271|NCT01691794|B4|Baseline|Total|Total of all reporting groups
81272|NCT01691794|B3|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81273|NCT01691794|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81274|NCT01691794|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81275|NCT01691794|P3|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81276|NCT01691794|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81277|NCT01691794|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81278|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81279|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81280|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81281|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81282|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81283|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81284|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81285|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81286|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81287|NCT01691794|E3|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81288|NCT01691794|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81289|NCT01691794|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
81290|NCT01690546|B1|Baseline|BUP/VLNXT to VIVITROL|
81291|NCT01690546|P1|Participant Flow|BUP/VLNXT to VIVITROL|
81292|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81293|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81294|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81295|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81296|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81297|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81298|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81299|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81300|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81301|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
81302|NCT01690546|E1|Reported Event|BUP/VLNXT to VIVITROL|
81303|NCT01691560|B5|Baseline|Total|Total of all reporting groups
81304|NCT01691560|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81305|NCT01691560|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81349|NCT01691534|P6|Participant Flow|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81307|NCT01691560|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81308|NCT01691560|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81309|NCT01691560|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81310|NCT01691560|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81311|NCT01691560|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
81312|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81313|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81314|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81315|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81316|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81317|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81318|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81319|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81320|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81321|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81322|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81323|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81324|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81325|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81326|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81327|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81328|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81329|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81330|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81331|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81332|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81333|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81334|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81335|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81336|NCT01691560|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
81337|NCT01691560|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
81338|NCT01691560|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81339|NCT01691560|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
81340|NCT01691534|B8|Baseline|Total|Total of all reporting groups
81341|NCT01691534|B7|Baseline|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81342|NCT01691534|B6|Baseline|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81343|NCT01691534|B5|Baseline|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81344|NCT01691534|B4|Baseline|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81345|NCT01691534|B3|Baseline|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81346|NCT01691534|B2|Baseline|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81347|NCT01691534|B1|Baseline|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81348|NCT01691534|P7|Participant Flow|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81351|NCT01691534|P4|Participant Flow|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81352|NCT01691534|P3|Participant Flow|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81353|NCT01691534|P2|Participant Flow|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81354|NCT01691534|P1|Participant Flow|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81355|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81356|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81357|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81358|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81359|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81360|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81361|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81362|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81363|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81364|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81365|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81366|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81367|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81368|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81369|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81370|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-1414
81371|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81372|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81373|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81374|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81375|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81376|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81377|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81378|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81379|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81380|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81381|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81382|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81383|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81384|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81385|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81386|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81387|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81388|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81389|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81390|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81391|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81392|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81393|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81394|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81395|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81396|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81397|NCT01691534|E7|Reported Event|Rifafour|Rifafour on Days 1 to 14, dosed by weight
81398|NCT01691534|E6|Reported Event|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
81399|NCT01691534|E5|Reported Event|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
81400|NCT01691534|E4|Reported Event|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81401|NCT01691534|E3|Reported Event|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81402|NCT01691534|E2|Reported Event|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
81403|NCT01691534|E1|Reported Event|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
81404|NCT01691521|B4|Baseline|Total|Total of all reporting groups
81405|NCT01691521|B3|Baseline|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81406|NCT01691521|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81407|NCT01691521|B1|Baseline|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81408|NCT01691521|P3|Participant Flow|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81409|NCT01691521|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81410|NCT01691521|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) plus placebo subcutaneously (SC) every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81411|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
81412|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81413|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81414|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
81415|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81416|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81417|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
81418|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81419|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81420|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
81421|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81422|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81423|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81424|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81425|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81426|NCT01691521|E3|Reported Event|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
81427|NCT01691521|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81428|NCT01691521|E1|Reported Event|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81429|NCT01691508|B3|Baseline|Total|Total of all reporting groups
81430|NCT01691508|B2|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81431|NCT01691508|B1|Baseline|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
82921|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
81432|NCT01691508|P2|Participant Flow|Mepolizumab 100mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81433|NCT01691508|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81434|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81435|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81436|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81437|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81438|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81439|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81440|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81441|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81442|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81443|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81444|NCT01691508|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81445|NCT01691508|E1|Reported Event|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
81446|NCT01691482|B1|Baseline|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
81447|NCT01691482|P2|Participant Flow|Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2|Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
81448|NCT01691482|P1|Participant Flow|A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2|Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
81449|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81450|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81451|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81490|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81452|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81453|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81454|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81455|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81456|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81457|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81458|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81459|NCT01691482|O1|Outcome|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
81460|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
81461|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
81462|NCT01691482|E1|Reported Event|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
81463|NCT01691339|B5|Baseline|Total|Total of all reporting groups
81464|NCT01691339|B4|Baseline|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81465|NCT01691339|B3|Baseline|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81466|NCT01691339|B2|Baseline|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81467|NCT01691339|B1|Baseline|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81468|NCT01691339|P4|Participant Flow|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81469|NCT01691339|P3|Participant Flow|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81470|NCT01691339|P2|Participant Flow|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81471|NCT01691339|P1|Participant Flow|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81472|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81473|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81474|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81475|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81476|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81477|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81478|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81479|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81480|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81481|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81482|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81483|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81484|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81485|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81491|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
81492|NCT01691339|E4|Reported Event|Fluzone High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
81493|NCT01691339|E3|Reported Event|Fluzone Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
81494|NCT01691339|E2|Reported Event|Fluzone Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
81495|NCT01691339|E1|Reported Event|Fluzone Vaccine (Group 1)|'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly'
81496|NCT01691326|B3|Baseline|Total|Total of all reporting groups
81497|NCT01691326|B2|Baseline|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81498|NCT01691326|B1|Baseline|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81499|NCT01691326|P2|Participant Flow|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
81500|NCT01691326|P1|Participant Flow|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81501|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81502|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81503|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81504|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81505|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81506|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81507|NCT01691326|O2|Outcome|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81508|NCT01691326|O1|Outcome|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81509|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81510|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81511|NCT01691326|E2|Reported Event|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
81512|NCT01691326|E1|Reported Event|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
81513|NCT01691313|B5|Baseline|Total|Total of all reporting groups
81514|NCT01691313|B4|Baseline|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
81515|NCT01691313|B3|Baseline|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
81516|NCT01691313|B2|Baseline|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
81517|NCT01691313|B1|Baseline|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
81518|NCT01691313|P4|Participant Flow|Vanoxerine 400mg|vanoxerine 400 mg (4x100mg oral capsules) single oral dose
81519|NCT01691313|P3|Participant Flow|Vanoxerine 300mg|vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
81520|NCT01691313|P2|Participant Flow|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
81521|NCT01691313|P1|Participant Flow|Vanoxerine 200mg|"vanoxerine 200 mg (2x 100mg oral capsules)~Vanoxerine: single oral dose"
81522|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
81523|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
81524|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
81525|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
81526|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
81527|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
81528|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
81529|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
81530|NCT01691313|E4|Reported Event|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
81531|NCT01691313|E3|Reported Event|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
81532|NCT01691313|E2|Reported Event|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
81533|NCT01691313|E1|Reported Event|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
81534|NCT01691248|B3|Baseline|Total|Total of all reporting groups
81535|NCT01691248|B2|Baseline|Placebo|Placebo tablet once daily for no longer than 40 days
81536|NCT01691248|B1|Baseline|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
81537|NCT01691248|P2|Participant Flow|Placebo|Placebo tablet once daily for no longer than 40 days
81538|NCT01691248|P1|Participant Flow|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
81539|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
81540|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
81541|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
81542|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
81543|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
81548|NCT01691014|B4|Baseline|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81549|NCT01691014|B3|Baseline|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81550|NCT01691014|B2|Baseline|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81551|NCT01691014|B1|Baseline|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81552|NCT01691014|P4|Participant Flow|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81553|NCT01691014|P3|Participant Flow|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81554|NCT01691014|P2|Participant Flow|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81555|NCT01691014|P1|Participant Flow|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81556|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81557|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81558|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81559|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81560|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81561|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81562|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81563|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81564|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81565|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81566|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81567|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81568|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81569|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81570|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81571|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81572|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81573|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81574|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81575|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81576|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81577|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81578|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81579|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81580|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81581|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81582|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81583|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
82922|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
81584|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81585|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81586|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81587|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81588|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81589|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81590|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81591|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81592|NCT01691014|E4|Reported Event|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81593|NCT01691014|E3|Reported Event|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81594|NCT01691014|E2|Reported Event|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
81595|NCT01691014|E1|Reported Event|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
81596|NCT01690923|B1|Baseline|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
81597|NCT01690923|P2|Participant Flow|Pillows Mask First, Then Nasal Mask|"Sequence 2: Pillows mask first, then Nasal mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
81598|NCT01690923|P1|Participant Flow|Nasal Mask First, Then Pillows Mask|"Sequence 1: Nasal mask first, then Pillows mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
81599|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
81600|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
81601|NCT01690923|E1|Reported Event|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
81602|NCT01690299|B4|Baseline|Total|Total of all reporting groups
81603|NCT01690299|B3|Baseline|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81604|NCT01690299|B2|Baseline|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml Placebo SC saline injections once QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81605|NCT01690299|B1|Baseline|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) Placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81606|NCT01690299|P3|Participant Flow|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81607|NCT01690299|P2|Participant Flow|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81608|NCT01690299|P1|Participant Flow|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81609|NCT01690299|O3|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81610|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml Placebo SC saline injections once QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81611|NCT01690299|O1|Outcome|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) Placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81612|NCT01690299|O3|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81613|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml Placebo SC saline injections once QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81614|NCT01690299|O1|Outcome|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) Placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81615|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81616|NCT01690299|O1|Outcome|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81617|NCT01690299|E3|Reported Event|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
82923|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
81618|NCT01690299|E2|Reported Event|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml Placebo SC saline injections once QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81619|NCT01690299|E1|Reported Event|Placebo|Placebo tablets orally (PO), twice a day (BID) and 2-1 milliliter (ml) Placebo subcutaneous (SC) saline injections once weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
81620|NCT01690273|B4|Baseline|Total|Total of all reporting groups
81621|NCT01690273|B3|Baseline|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
81622|NCT01690273|B2|Baseline|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
81623|NCT01690273|B1|Baseline|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
81624|NCT01690273|P3|Participant Flow|Mobility and Elastic Resistance Exercise in AS|"mobility, plus elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81625|NCT01690273|P2|Participant Flow|Mobility in Ankylosing Spondylitis|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81626|NCT01690273|P1|Participant Flow|Ankylosing Spondylitis Control|control group, no intervention in ankylosing spondylitis patients
81627|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81628|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81629|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81630|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81631|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81632|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81633|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81634|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81635|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81636|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81637|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81638|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81639|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81640|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81641|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81642|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81643|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81644|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81645|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81646|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81647|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81648|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81649|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81650|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81651|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81652|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81653|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81654|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81655|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81656|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81657|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81658|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81659|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
81660|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81661|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81663|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
81664|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week for sixteen weeks."
81665|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
81666|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81667|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81668|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
81669|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
81670|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
81671|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
81672|NCT01690273|E3|Reported Event|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
81673|NCT01690273|E2|Reported Event|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
81674|NCT01690273|E1|Reported Event|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
81675|NCT01690117|B3|Baseline|Total|Total of all reporting groups
81676|NCT01690117|B2|Baseline|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81677|NCT01690117|B1|Baseline|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81678|NCT01690117|P2|Participant Flow|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81679|NCT01690117|P1|Participant Flow|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81680|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81681|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81682|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81683|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81684|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81685|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81686|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81687|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81688|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81689|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81690|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81691|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81692|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81693|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81694|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81695|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81696|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81697|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81698|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
81699|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81700|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81701|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81702|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81703|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81704|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81705|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81706|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81707|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81708|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81709|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81710|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
81711|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
81712|NCT01690117|E2|Reported Event|Control Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
81713|NCT01690117|E1|Reported Event|Intervention Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
81714|NCT01690052|B1|Baseline|All Participants|"Two interventions were assembled:~For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.~For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week."
81715|NCT01690052|P2|Participant Flow|Pilocarpine First, Then Cevimeline|Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
81716|NCT01690052|P1|Participant Flow|Cevimeline First, Then Pilocarpine|Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
81717|NCT01690052|O2|Outcome|Pilocarpine|Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
81718|NCT01690052|O1|Outcome|Cevimeline|Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
81719|NCT01690052|E2|Reported Event|Pilocarpine Then Cevimeline (Intervention 2)|Pilocarpine then cevimeline One week washout period
81720|NCT01690052|E1|Reported Event|Cevimeline Then Pilocarpine (Intervention 1)|Cevimeline then pilocarpine One week washout period
81721|NCT01690000|B3|Baseline|Total|Total of all reporting groups
81722|NCT01690000|B2|Baseline|Placebo|Identical placebo given nightly for 12 months
81723|NCT01690000|B1|Baseline|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
81724|NCT01690000|P2|Participant Flow|Placebo|Identical placebo given nightly for 12 months
81725|NCT01690000|P1|Participant Flow|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
81726|NCT01690000|O2|Outcome|Placebo|"Identical placebo given nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
81727|NCT01690000|O1|Outcome|Melatonin1+3|"1+3 mg melatonin nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
81728|NCT01690000|E2|Reported Event|Placebo|Identical placebo given nightly for 12 months
81729|NCT01690000|E1|Reported Event|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
81730|NCT01689857|B3|Baseline|Total|Total of all reporting groups
81731|NCT01689857|B2|Baseline|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
81732|NCT01689857|B1|Baseline|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
81733|NCT01689857|P2|Participant Flow|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
81734|NCT01689857|P1|Participant Flow|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
81735|NCT01689857|O2|Outcome|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
81736|NCT01689857|O1|Outcome|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
81737|NCT01689857|E2|Reported Event|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
81739|NCT01689649|B1|Baseline|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81740|NCT01689649|P1|Participant Flow|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81741|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81742|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81743|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81744|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81745|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81746|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81747|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81748|NCT01689649|E1|Reported Event|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
81749|NCT01689532|B3|Baseline|Total|Total of all reporting groups
81750|NCT01689532|B2|Baseline|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81751|NCT01689532|B1|Baseline|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81752|NCT01689532|P2|Participant Flow|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81753|NCT01689532|P1|Participant Flow|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81754|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81755|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81756|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81757|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81758|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81759|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81760|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81761|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81762|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81763|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81764|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81765|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81766|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81767|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81768|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81769|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81770|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81771|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81772|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81773|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81774|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81775|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81776|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81777|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81778|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81779|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81780|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81781|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81782|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81783|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81784|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81785|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81786|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81787|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81788|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81789|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81790|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81791|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81792|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81793|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81794|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81795|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81796|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81854|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81797|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81798|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81799|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81800|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81801|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81802|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81803|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81804|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81805|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81806|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81807|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81808|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81809|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81810|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81811|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81812|NCT01689532|E2|Reported Event|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
81813|NCT01689532|E1|Reported Event|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
81814|NCT01689519|B3|Baseline|Total|Total of all reporting groups
81815|NCT01689519|B2|Baseline|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81816|NCT01689519|B1|Baseline|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81817|NCT01689519|P2|Participant Flow|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81818|NCT01689519|P1|Participant Flow|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81819|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81820|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81821|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81822|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81823|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81824|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81935|NCT01689207|B11|Baseline|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81825|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81826|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81827|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81828|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81829|NCT01689519|E2|Reported Event|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81830|NCT01689519|E1|Reported Event|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
81831|NCT01689441|B3|Baseline|Total|Total of all reporting groups
81832|NCT01689441|B2|Baseline|Placebo|"Normal saline 2cc IV x 1~Placebo"
81833|NCT01689441|B1|Baseline|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81834|NCT01689441|P2|Participant Flow|Placebo|"Normal saline 2cc IV x 1~Placebo"
81835|NCT01689441|P1|Participant Flow|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81836|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
81837|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81838|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
81839|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81840|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
81841|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81842|NCT01689441|E2|Reported Event|Placebo|"Normal saline 2cc IV x 1~Placebo"
81843|NCT01689441|E1|Reported Event|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
81844|NCT01689363|B1|Baseline|Total Study Population|Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects’ forearms.
81845|NCT01689363|P8|Participant Flow|P, H, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
81846|NCT01689363|P7|Participant Flow|P, H, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
81847|NCT01689363|P6|Participant Flow|N, H, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
81848|NCT01689363|P5|Participant Flow|N, H, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
81849|NCT01689363|P4|Participant Flow|H, P, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
81850|NCT01689363|P3|Participant Flow|H, P, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
81851|NCT01689363|P2|Participant Flow|H, N, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
81852|NCT01689363|P1|Participant Flow|H, N, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
81853|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81855|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81856|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81857|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81858|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81859|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81860|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81861|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81862|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81863|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81864|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81865|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81866|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81867|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81868|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81869|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81870|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81871|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81872|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81873|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81874|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81875|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81876|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81877|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81878|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81879|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81880|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81881|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81882|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81883|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81884|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81885|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81886|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81887|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81888|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81889|NCT01689363|O1|Outcome|Intent-to-Treat Population (ITT)|Subjects who have been randomized
81890|NCT01689363|O1|Outcome|Per-Protocol Population (PPP)|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments
81891|NCT01689363|E4|Reported Event|All Arms|Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time
81892|NCT01689363|E3|Reported Event|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
81893|NCT01689363|E2|Reported Event|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
81894|NCT01689363|E1|Reported Event|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
81895|NCT01689350|B3|Baseline|Total|Total of all reporting groups
81896|NCT01689350|B2|Baseline|Experimental Group|47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
81897|NCT01689350|B1|Baseline|Control Group|45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
81898|NCT01689350|P2|Participant Flow|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
81899|NCT01689350|P1|Participant Flow|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
81900|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
81901|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
81902|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
81903|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
81904|NCT01689350|E2|Reported Event|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
81905|NCT01689350|E1|Reported Event|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
81906|NCT01689337|B1|Baseline|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
81907|NCT01689337|P1|Participant Flow|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
81908|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81909|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81910|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81911|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81912|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81913|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81914|NCT01689337|O1|Outcome|AS902330, 100 mcg|AS902330 was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81915|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
81916|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81917|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
81918|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81919|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
81920|NCT01689337|E1|Reported Event|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
81921|NCT01689324|B1|Baseline|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81922|NCT01689324|P1|Participant Flow|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81923|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81924|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81925|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81926|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81927|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81928|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81929|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81930|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81931|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81932|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
81933|NCT01689324|E1|Reported Event|Study Group|Participants received a single booster dose of Tdap vaccine on Day 0.
81934|NCT01689207|B12|Baseline|Total|Total of all reporting groups
81936|NCT01689207|B10|Baseline|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81937|NCT01689207|B9|Baseline|Part C: Placebo|Placebo
81938|NCT01689207|B8|Baseline|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81939|NCT01689207|B7|Baseline|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81940|NCT01689207|B6|Baseline|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81941|NCT01689207|B5|Baseline|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81942|NCT01689207|B4|Baseline|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81943|NCT01689207|B3|Baseline|Part B: Placebo|Placebo
81944|NCT01689207|B2|Baseline|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
81945|NCT01689207|B1|Baseline|Part A: Placebo|Placebo
81946|NCT01689207|P11|Participant Flow|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81947|NCT01689207|P10|Participant Flow|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81948|NCT01689207|P9|Participant Flow|Part C: Placebo|Placebo
81949|NCT01689207|P8|Participant Flow|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81950|NCT01689207|P7|Participant Flow|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81951|NCT01689207|P6|Participant Flow|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81952|NCT01689207|P5|Participant Flow|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81953|NCT01689207|P4|Participant Flow|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81954|NCT01689207|P3|Participant Flow|Part B: Placebo|Placebo
81955|NCT01689207|P2|Participant Flow|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
81956|NCT01689207|P1|Participant Flow|Part A: Placebo|Placebo
81957|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81958|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81959|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
81960|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81961|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81962|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81963|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81964|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81965|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
81966|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
81967|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
81968|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81969|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81970|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
81971|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81972|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81973|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81974|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81975|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81976|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
81977|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
81978|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
81979|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81980|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81981|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
81982|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81983|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81984|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81985|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81986|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81987|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
81988|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
81989|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
81990|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
81991|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
81992|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
81993|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
81994|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
81995|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
81996|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
81997|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
81998|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
81999|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
82000|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
82001|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
82002|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
82003|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
82004|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
82005|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
82006|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
82010|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
82011|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
82012|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
82013|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
82014|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
82015|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
82016|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
82017|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
82018|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
82019|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
82020|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
82021|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
82022|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
82023|NCT01689207|O14|Outcome|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
82024|NCT01689207|O13|Outcome|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
82025|NCT01689207|O12|Outcome|Part A: Aztreonam (ATM) 2000mg|Crossover period ATm 2000mg
82026|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
82027|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
82028|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
82029|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
82030|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
82031|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
82032|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
82033|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
82034|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
82035|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
82036|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
82037|NCT01689207|E14|Reported Event|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
82038|NCT01689207|E13|Reported Event|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
82039|NCT01689207|E12|Reported Event|Part A: Aztreonam (ATM) 2000mg|Crossover period ATM 2000mg
82040|NCT01689207|E11|Reported Event|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
82041|NCT01689207|E10|Reported Event|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
82042|NCT01689207|E9|Reported Event|Part C: Placebo|Placebo
82043|NCT01689207|E8|Reported Event|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
82044|NCT01689207|E7|Reported Event|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
82045|NCT01689207|E6|Reported Event|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
82046|NCT01689207|E5|Reported Event|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
82047|NCT01689207|E4|Reported Event|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
82048|NCT01689207|E3|Reported Event|Part B: Placebo|Placebo
82049|NCT01689207|E2|Reported Event|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
82050|NCT01689207|E1|Reported Event|Part A: Placebo|Placebo
82051|NCT01689155|B1|Baseline|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
82052|NCT01689155|P1|Participant Flow|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
82053|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
82054|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
82055|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
82056|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
82057|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
82058|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
82059|NCT01689155|E1|Reported Event|Menactra Vaccine Recipients|Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
82060|NCT01688921|B3|Baseline|Total|Total of all reporting groups
82061|NCT01688921|B2|Baseline|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82062|NCT01688921|B1|Baseline|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
82063|NCT01688921|P2|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82064|NCT01688921|P1|Participant Flow|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
82065|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82066|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82067|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82068|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82069|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82070|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82071|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82072|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82073|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82074|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82075|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82076|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82077|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82078|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82079|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82080|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82081|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82082|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82083|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
82084|NCT01688921|E2|Reported Event|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
82447|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82085|NCT01688921|E1|Reported Event|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
82086|NCT01688882|B3|Baseline|Total|Total of all reporting groups
82087|NCT01688882|B2|Baseline|Placebo|Placebo to Match Q2W s.c.
82088|NCT01688882|B1|Baseline|QGE031|QGE031 240 mg Q2W s.c.
82089|NCT01688882|P2|Participant Flow|Placebo|Placebo to Match Q2W s.c.
82090|NCT01688882|P1|Participant Flow|QGE031|QGE031 240 mg Q2W s.c.
82091|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
82092|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
82093|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
82094|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
82095|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
82096|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
82097|NCT01688882|E6|Reported Event|Follow-up Period: Open Label QGE031|Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
82098|NCT01688882|E5|Reported Event|Follow-up Period: Placebo|Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
82099|NCT01688882|E4|Reported Event|Follow-up Period: QGE031|Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
82100|NCT01688882|E3|Reported Event|Open Label QGE031|Open Label QGE031 Q2W s.c.
82101|NCT01688882|E2|Reported Event|Placebo|Placebo to Match Q2W s.c.
82102|NCT01688882|E1|Reported Event|QGE031|QGE031 240 mg Q2W s.c
82103|NCT01688830|B22|Baseline|Total|Total of all reporting groups
82104|NCT01688830|B21|Baseline|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82105|NCT01688830|B20|Baseline|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82106|NCT01688830|B19|Baseline|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82107|NCT01688830|B18|Baseline|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82108|NCT01688830|B17|Baseline|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82109|NCT01688830|B16|Baseline|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82110|NCT01688830|B15|Baseline|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82111|NCT01688830|B14|Baseline|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82112|NCT01688830|B13|Baseline|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82113|NCT01688830|B12|Baseline|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82114|NCT01688830|B11|Baseline|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82115|NCT01688830|B10|Baseline|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82116|NCT01688830|B9|Baseline|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82117|NCT01688830|B8|Baseline|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82118|NCT01688830|B7|Baseline|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82119|NCT01688830|B6|Baseline|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82120|NCT01688830|B5|Baseline|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82121|NCT01688830|B4|Baseline|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82122|NCT01688830|B3|Baseline|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82123|NCT01688830|B2|Baseline|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82124|NCT01688830|B1|Baseline|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82125|NCT01688830|P21|Participant Flow|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82126|NCT01688830|P20|Participant Flow|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82127|NCT01688830|P19|Participant Flow|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82128|NCT01688830|P18|Participant Flow|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82129|NCT01688830|P17|Participant Flow|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82130|NCT01688830|P16|Participant Flow|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82131|NCT01688830|P15|Participant Flow|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82132|NCT01688830|P14|Participant Flow|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82133|NCT01688830|P13|Participant Flow|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82134|NCT01688830|P12|Participant Flow|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82135|NCT01688830|P11|Participant Flow|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82136|NCT01688830|P10|Participant Flow|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82137|NCT01688830|P9|Participant Flow|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82138|NCT01688830|P8|Participant Flow|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82139|NCT01688830|P7|Participant Flow|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82140|NCT01688830|P6|Participant Flow|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82141|NCT01688830|P5|Participant Flow|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82142|NCT01688830|P4|Participant Flow|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82143|NCT01688830|P3|Participant Flow|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82144|NCT01688830|P2|Participant Flow|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82145|NCT01688830|P1|Participant Flow|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82146|NCT01688830|O2|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82147|NCT01688830|O1|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82148|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82149|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82150|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82151|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82152|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82207|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82153|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82154|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
82155|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82156|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82157|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82158|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82159|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
82160|NCT01688830|O6|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82161|NCT01688830|O5|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82162|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82163|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82164|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82165|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82166|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82167|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82168|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
82169|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82170|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82171|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82172|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82173|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
82174|NCT01688830|O21|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82175|NCT01688830|O20|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82441|NCT01687088|O1|Outcome|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
82176|NCT01688830|O19|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82177|NCT01688830|O18|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82178|NCT01688830|O17|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82179|NCT01688830|O16|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82180|NCT01688830|O15|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82181|NCT01688830|O14|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82182|NCT01688830|O13|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82183|NCT01688830|O12|Outcome|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82184|NCT01688830|O11|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82185|NCT01688830|O10|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82186|NCT01688830|O9|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82187|NCT01688830|O8|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82188|NCT01688830|O7|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82189|NCT01688830|O6|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82190|NCT01688830|O5|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82191|NCT01688830|O4|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82192|NCT01688830|O3|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82193|NCT01688830|O2|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82194|NCT01688830|O1|Outcome|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
82195|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82196|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82197|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82198|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82199|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82200|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82201|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82202|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82203|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82204|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82205|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82206|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82442|NCT01687088|E2|Reported Event|Controls|No significant headache or disability as defined by migraine disability scale.
82208|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82209|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82210|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82211|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82212|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82213|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82214|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82215|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82216|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82217|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82218|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82219|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82220|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82221|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82222|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82223|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82224|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82225|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82226|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82227|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82228|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82229|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82230|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82231|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82232|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82233|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82234|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82235|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82236|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82237|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82238|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82239|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82240|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82241|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82242|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82243|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82244|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82245|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82246|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82247|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82248|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82249|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82250|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82251|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82252|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
82253|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
82254|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
82255|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
82256|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
82257|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
82258|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
82259|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
82260|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
82261|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
82262|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
82263|NCT01688830|E25|Reported Event|DE+ 5 g + 2.5 g Idarucizumab|"Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82264|NCT01688830|E24|Reported Event|DE+ 5 g|"One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82265|NCT01688830|E23|Reported Event|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82266|NCT01688830|E22|Reported Event|DE+ Placebo|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82267|NCT01688830|E21|Reported Event|DE (Dose Groups 17)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
82268|NCT01688830|E20|Reported Event|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82269|NCT01688830|E19|Reported Event|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82270|NCT01688830|E18|Reported Event|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82271|NCT01688830|E17|Reported Event|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
82272|NCT01688830|E16|Reported Event|DE (Dose Groups 14−16)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
82273|NCT01688830|E15|Reported Event|4 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
82274|NCT01688830|E14|Reported Event|2 g Idarucizumab 5min|Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
82275|NCT01688830|E13|Reported Event|1 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
82276|NCT01688830|E12|Reported Event|Placebo 5min|One single intravenous short infusion (5 min) of Idarucizumab Placebo
82277|NCT01688830|E11|Reported Event|8 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
82278|NCT01688830|E10|Reported Event|6 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
82279|NCT01688830|E9|Reported Event|4 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
82280|NCT01688830|E8|Reported Event|3 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
82281|NCT01688830|E7|Reported Event|2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
82282|NCT01688830|E6|Reported Event|1.2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
82283|NCT01688830|E5|Reported Event|600 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
82284|NCT01688830|E4|Reported Event|200 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
82285|NCT01688830|E3|Reported Event|60 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
82286|NCT01688830|E2|Reported Event|20 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
82287|NCT01688830|E1|Reported Event|Placebo 1 h|One single intravenous long infusion (1 h) of Idarucizumab Placebo
82288|NCT01688726|B3|Baseline|Total|Total of all reporting groups
82289|NCT01688726|B2|Baseline|Minims Saline|One drop 4 times a day for a continuous period of 1 month
82290|NCT01688726|B1|Baseline|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
82291|NCT01688726|P2|Participant Flow|Minims Saline|One drop 4 times a day for a continuous period of 1 month
82292|NCT01688726|P1|Participant Flow|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
82293|NCT01688726|O4|Outcome|Minims Saline/Left Eye|One drop 4 times a day for 1 month
82294|NCT01688726|O3|Outcome|Minims Saline/Right Eye|One drop 4 times a day for 1 month
82295|NCT01688726|O2|Outcome|SYSTANE BALANCE/Left Eye|One drop 4 times a day for 1 month
82296|NCT01688726|O1|Outcome|SYSTANE BALANCE/Right Eye|One drop 4 times a day for 1 month
82297|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
82298|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
82299|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
82300|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
82301|NCT01688726|E2|Reported Event|Minims Saline|One drop 4 times a day for a continuous period of 1 month
82302|NCT01688726|E1|Reported Event|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
82303|NCT01688635|B1|Baseline|LY2963016 and US-approved Lantus|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
82304|NCT01688635|P2|Participant Flow|Lantus/LY/Lantus/LY|"A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
82305|NCT01688635|P1|Participant Flow|LY/Lantus/LY/Lantus|"A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
82306|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82307|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82308|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82309|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82310|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82311|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82312|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
82443|NCT01687088|E1|Reported Event|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
82313|NCT01688635|O1|Outcome|LY2963016|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
82314|NCT01688635|E2|Reported Event|US-approved Lantus|"Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
82315|NCT01688635|E1|Reported Event|LY2963016|"Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
82316|NCT01688310|B3|Baseline|Total|Total of all reporting groups
82317|NCT01688310|B2|Baseline|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82318|NCT01688310|B1|Baseline|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82319|NCT01688310|P2|Participant Flow|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82320|NCT01688310|P1|Participant Flow|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82321|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82322|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82323|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82324|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82325|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82326|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82327|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82328|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82329|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82330|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82331|NCT01688310|O2|Outcome|Junior Physicians|Physicians who had very limited prior experience performing open surgical circumcisions.
82332|NCT01688310|O1|Outcome|Senior Physicians|Physicians who had extensive prior experience performing open surgical circumcisions.
82333|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82334|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82335|NCT01688310|E2|Reported Event|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
82336|NCT01688310|E1|Reported Event|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
82337|NCT01688102|B3|Baseline|Total|Total of all reporting groups
82338|NCT01688102|B2|Baseline|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
82339|NCT01688102|B1|Baseline|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
82340|NCT01688102|P2|Participant Flow|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
82924|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82341|NCT01688102|P1|Participant Flow|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
82342|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
82343|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
82344|NCT01688102|E2|Reported Event|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
82345|NCT01688102|E1|Reported Event|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
82346|NCT01688050|B1|Baseline|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82347|NCT01688050|P1|Participant Flow|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82348|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82349|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82350|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82351|NCT01688050|E1|Reported Event|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
82352|NCT01687790|B1|Baseline|Molecular Breast Imaging|molecular breast imaging (Discovery)
82353|NCT01687790|P1|Participant Flow|Molecular Breast Imaging|molecular breast imaging (Discovery)
82354|NCT01687790|O1|Outcome|Molecular Breast Imaging|molecular breast imaging (Discovery)
82355|NCT01687790|O1|Outcome|Molecular Breast Imaging|Participants received molecular breast imaging before biopsy
82356|NCT01687790|E1|Reported Event|Molecular Breast Imaging|molecular breast imaging (Discovery)
82357|NCT01687270|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82358|NCT01687270|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82359|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82360|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82361|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82362|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82363|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82364|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82365|NCT01687270|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
82366|NCT01687257|B3|Baseline|Total|Total of all reporting groups
82367|NCT01687257|B2|Baseline|SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
82368|NCT01687257|B1|Baseline|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82369|NCT01687257|P3|Participant Flow|Observation/SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
82370|NCT01687257|P2|Participant Flow|Observation/SOF+RBV (Group 2; Not Treated)|This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
82371|NCT01687257|P1|Participant Flow|SOF+RBV (Group 1)|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82372|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
82373|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
82374|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
82375|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
82376|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
82444|NCT01687036|B1|Baseline|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82377|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
82378|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
82379|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
82380|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2
82381|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 48 weeks
82382|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
82383|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
82384|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82385|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82386|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82387|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82388|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82389|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82390|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82391|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
82392|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82393|NCT01687257|E3|Reported Event|SOF+RBV Treatment Only (Group 2)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
82394|NCT01687257|E2|Reported Event|Observation Period Only (Group 2)|This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation.
82395|NCT01687257|E1|Reported Event|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
82396|NCT01687218|B7|Baseline|Total|Total of all reporting groups
82397|NCT01687218|B6|Baseline|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82398|NCT01687218|B5|Baseline|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82399|NCT01687218|B4|Baseline|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82400|NCT01687218|B3|Baseline|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82401|NCT01687218|B2|Baseline|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82402|NCT01687218|B1|Baseline|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82445|NCT01687036|P1|Participant Flow|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3)."
82446|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82925|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82403|NCT01687218|P6|Participant Flow|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82404|NCT01687218|P5|Participant Flow|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82405|NCT01687218|P4|Participant Flow|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82406|NCT01687218|P3|Participant Flow|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82407|NCT01687218|P2|Participant Flow|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82408|NCT01687218|P1|Participant Flow|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
82409|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82410|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
82411|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
82412|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82413|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
82414|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
82415|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82416|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
82417|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
82418|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82419|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
82420|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
82421|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82422|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
82423|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
82424|NCT01687218|E3|Reported Event|Product 3|Rectal (RAI-associated TFV RG 1% gel)
82425|NCT01687218|E2|Reported Event|Product 2|Rectal (Daily TFV RG 1% gel)
82426|NCT01687218|E1|Reported Event|Product 1|Oral (Daily FTC/TDF)
82427|NCT01687114|B1|Baseline|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
82428|NCT01687114|P1|Participant Flow|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
82429|NCT01687114|O1|Outcome|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
82430|NCT01687114|E1|Reported Event|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
82431|NCT01687101|B1|Baseline|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
82432|NCT01687101|P1|Participant Flow|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
82433|NCT01687101|O1|Outcome|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
82434|NCT01687101|E1|Reported Event|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
82435|NCT01687088|B3|Baseline|Total|Total of all reporting groups
82436|NCT01687088|B2|Baseline|Controls|No significant headache or disability as defined by migraine disability scale.
82437|NCT01687088|B1|Baseline|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
82438|NCT01687088|P2|Participant Flow|Controls|No significant headache or disability as defined by migraine disability scale.
82439|NCT01687088|P1|Participant Flow|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
82440|NCT01687088|O2|Outcome|Controls|No significant headache or disability as defined by migraine disability scale.
82448|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82449|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82450|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82451|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82452|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82453|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82454|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82455|NCT01687036|E1|Reported Event|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
82456|NCT01686932|B3|Baseline|Total|Total of all reporting groups
82457|NCT01686932|B2|Baseline|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
82458|NCT01686932|B1|Baseline|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
82459|NCT01686932|P2|Participant Flow|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
82460|NCT01686932|P1|Participant Flow|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
82461|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82462|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82463|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82464|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82465|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82466|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82467|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82468|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82469|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82470|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82471|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82472|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82473|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82474|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82475|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82476|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82477|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82478|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82479|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82480|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82481|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82482|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82483|NCT01686932|E2|Reported Event|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
82484|NCT01686932|E1|Reported Event|Vildagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
82485|NCT01686646|B5|Baseline|Total|Total of all reporting groups
82486|NCT01686646|B4|Baseline|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82487|NCT01686646|B3|Baseline|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82488|NCT01686646|B2|Baseline|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82489|NCT01686646|B1|Baseline|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82490|NCT01686646|P4|Participant Flow|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82491|NCT01686646|P3|Participant Flow|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82492|NCT01686646|P2|Participant Flow|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82493|NCT01686646|P1|Participant Flow|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.
82494|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82495|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82496|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82497|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82498|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82499|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82500|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82501|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82502|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82503|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82504|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82505|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82506|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82507|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82508|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82509|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82510|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82511|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82512|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82513|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82514|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82515|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82516|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82517|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82518|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82519|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82520|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82521|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82522|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82523|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82524|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82525|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82526|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82527|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82528|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82529|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82530|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82531|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82532|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82533|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82534|NCT01686646|E4|Reported Event|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
82535|NCT01686646|E3|Reported Event|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
82536|NCT01686646|E2|Reported Event|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
82537|NCT01686646|E1|Reported Event|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
82538|NCT01686633|B4|Baseline|Total|Total of all reporting groups
82926|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82539|NCT01686633|B3|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82540|NCT01686633|B2|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82541|NCT01686633|B1|Baseline|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82542|NCT01686633|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82543|NCT01686633|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82544|NCT01686633|P1|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82545|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82546|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82547|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82548|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82549|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82550|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82551|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82552|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82553|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82554|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82555|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82556|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82557|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82558|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82559|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82560|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82561|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82562|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82563|NCT01686633|E3|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82564|NCT01686633|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82565|NCT01686633|E1|Reported Event|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
82566|NCT01686568|B3|Baseline|Total|Total of all reporting groups
82567|NCT01686568|B2|Baseline|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82568|NCT01686568|B1|Baseline|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
82569|NCT01686568|P2|Participant Flow|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82570|NCT01686568|P1|Participant Flow|Omega-3|Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.
82571|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82572|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
82573|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82574|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
82575|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82576|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
82577|NCT01686568|E2|Reported Event|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
82578|NCT01686568|E1|Reported Event|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
82579|NCT01686503|B5|Baseline|Total|Total of all reporting groups
82580|NCT01686503|B4|Baseline|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82581|NCT01686503|B3|Baseline|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82582|NCT01686503|B2|Baseline|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82583|NCT01686503|B1|Baseline|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82584|NCT01686503|P4|Participant Flow|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82585|NCT01686503|P3|Participant Flow|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82586|NCT01686503|P2|Participant Flow|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82587|NCT01686503|P1|Participant Flow|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82588|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82589|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82590|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82591|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82592|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82593|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82594|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82595|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82596|NCT01686503|E4|Reported Event|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82597|NCT01686503|E3|Reported Event|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82598|NCT01686503|E2|Reported Event|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82599|NCT01686503|E1|Reported Event|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
82600|NCT01686451|B3|Baseline|Total|Total of all reporting groups
82601|NCT01686451|B2|Baseline|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82602|NCT01686451|B1|Baseline|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82603|NCT01686451|P2|Participant Flow|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82604|NCT01686451|P1|Participant Flow|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82605|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82606|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82607|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82608|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82609|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82610|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82611|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82612|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82613|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82614|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82615|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82616|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82617|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82618|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82927|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82619|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82620|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82621|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82622|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82623|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82624|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82625|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82626|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82627|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82628|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82629|NCT01686451|E2|Reported Event|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
82630|NCT01686451|E1|Reported Event|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
82631|NCT01685983|B1|Baseline|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82632|NCT01685983|P1|Participant Flow|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82633|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82634|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82635|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82636|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82637|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82638|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82639|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82640|NCT01685983|E1|Reported Event|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
82641|NCT01685801|B5|Baseline|Total|Total of all reporting groups
82642|NCT01685801|B4|Baseline|PIPI|Detailed reporting group description is provided in Participant Flow module.
82643|NCT01685801|B3|Baseline|PIIP|Detailed reporting group description is provided in Participant Flow module.
82644|NCT01685801|B2|Baseline|IPPI|Detailed reporting group description is provided in Participant Flow module.
82645|NCT01685801|B1|Baseline|IPIP|Detailed reporting group description is provided in Participant Flow module.
82646|NCT01685801|P4|Participant Flow|Placebo, Ivacaftor, Placebo, Ivacaftor (PIPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
82647|NCT01685801|P3|Participant Flow|Placebo, Ivacaftor, Ivacaftor, Placebo (PIIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
82928|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82648|NCT01685801|P2|Participant Flow|Ivacaftor, Placebo, Placebo, Ivacaftor (IPPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
82649|NCT01685801|P1|Participant Flow|Ivacaftor, Placebo, Ivacaftor, Placebo (IPIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
82650|NCT01685801|O3|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
82651|NCT01685801|O2|Outcome|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
82652|NCT01685801|O1|Outcome|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
82653|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
82654|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
82655|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours in open-label period (8 weeks) after washout period 2.
82656|NCT01685801|O1|Outcome|Open-Label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
82657|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 2.
82658|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
82659|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 1.
82660|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
82661|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
82662|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
82663|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
82664|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
82665|NCT01685801|E3|Reported Event|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
82666|NCT01685801|E2|Reported Event|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
82667|NCT01685801|E1|Reported Event|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
82668|NCT01685606|B1|Baseline|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
82669|NCT01685606|P1|Participant Flow|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
82670|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
82671|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
82672|NCT01685606|E1|Reported Event|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
82673|NCT01685437|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82674|NCT01685437|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82675|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82676|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82677|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82740|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82678|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82679|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82680|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82681|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82682|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82683|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82684|NCT01685437|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
82685|NCT01685320|B3|Baseline|Total|Total of all reporting groups
82686|NCT01685320|B2|Baseline|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82687|NCT01685320|B1|Baseline|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82688|NCT01685320|P2|Participant Flow|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82689|NCT01685320|P1|Participant Flow|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82690|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82691|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82692|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82693|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82694|NCT01685320|E2|Reported Event|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82695|NCT01685320|E1|Reported Event|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
82696|NCT01685216|B1|Baseline|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82697|NCT01685216|P1|Participant Flow|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82698|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82699|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82700|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82701|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82702|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82703|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82704|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82705|NCT01685216|E1|Reported Event|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
82706|NCT01685203|B8|Baseline|Total|Total of all reporting groups
82707|NCT01685203|B7|Baseline|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82708|NCT01685203|B6|Baseline|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82709|NCT01685203|B5|Baseline|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82870|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82710|NCT01685203|B4|Baseline|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82711|NCT01685203|B3|Baseline|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82712|NCT01685203|B2|Baseline|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82713|NCT01685203|B1|Baseline|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82714|NCT01685203|P7|Participant Flow|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82715|NCT01685203|P6|Participant Flow|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82716|NCT01685203|P5|Participant Flow|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82717|NCT01685203|P4|Participant Flow|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82718|NCT01685203|P3|Participant Flow|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82719|NCT01685203|P2|Participant Flow|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82720|NCT01685203|P1|Participant Flow|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82721|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82722|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82723|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82724|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82725|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82726|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82727|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82728|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82729|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82730|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82731|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82732|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82733|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82734|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82735|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82736|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82737|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82738|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82739|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82929|NCT01683838|E2|Reported Event|Placebo|Placebo : Placebo
82741|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82742|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82743|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82744|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82745|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82746|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82747|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82748|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82749|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82750|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82751|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
82752|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82753|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82754|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82755|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82756|NCT01685203|E7|Reported Event|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
82757|NCT01685203|E6|Reported Event|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
82758|NCT01685203|E5|Reported Event|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants
82759|NCT01685203|E4|Reported Event|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82760|NCT01685203|E3|Reported Event|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
82761|NCT01685203|E2|Reported Event|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
82762|NCT01685203|E1|Reported Event|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
82763|NCT01684930|B3|Baseline|Total|Total of all reporting groups
82764|NCT01684930|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82765|NCT01684930|B1|Baseline|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82837|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82766|NCT01684930|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82767|NCT01684930|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82768|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82769|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82770|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82771|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82772|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82773|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82916|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82774|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82775|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82776|NCT01684930|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
82777|NCT01684930|E1|Reported Event|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
82778|NCT01684878|B5|Baseline|Total|Total of all reporting groups
82779|NCT01684878|B4|Baseline|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82780|NCT01684878|B3|Baseline|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82781|NCT01684878|B2|Baseline|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82782|NCT01684878|B1|Baseline|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82783|NCT01684878|P4|Participant Flow|Part 2: Placebo+Chemotherapy|Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82784|NCT01684878|P3|Participant Flow|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82785|NCT01684878|P2|Participant Flow|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
82786|NCT01684878|P1|Participant Flow|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
82787|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82788|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82789|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82917|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82790|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82791|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82792|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82793|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82794|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82795|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82796|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82797|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82798|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82799|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82800|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82801|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82802|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
82803|NCT01684878|E4|Reported Event|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82804|NCT01684878|E3|Reported Event|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
82805|NCT01684878|E2|Reported Event|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
82806|NCT01684878|E1|Reported Event|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
82807|NCT01684839|B1|Baseline|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
82808|NCT01684839|P1|Participant Flow|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
82809|NCT01684839|O1|Outcome|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
82810|NCT01684839|E1|Reported Event|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
82811|NCT01684826|B1|Baseline|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82812|NCT01684826|P1|Participant Flow|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82813|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82814|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82815|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82816|NCT01684826|E1|Reported Event|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
82817|NCT01684748|B3|Baseline|Total|Total of all reporting groups
82838|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82818|NCT01684748|B2|Baseline|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
82819|NCT01684748|B1|Baseline|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
82820|NCT01684748|P2|Participant Flow|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
82821|NCT01684748|P1|Participant Flow|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
82822|NCT01684748|O2|Outcome|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
82823|NCT01684748|O1|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
82824|NCT01684748|E2|Reported Event|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
82825|NCT01684748|E1|Reported Event|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
82826|NCT01684566|B3|Baseline|Total|Total of all reporting groups
82827|NCT01684566|B2|Baseline|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82828|NCT01684566|B1|Baseline|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82829|NCT01684566|P2|Participant Flow|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82830|NCT01684566|P1|Participant Flow|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82831|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82832|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82833|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82834|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82835|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82836|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82918|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82839|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82840|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82841|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82842|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82843|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82844|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82845|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82846|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82847|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82848|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82849|NCT01684566|E2|Reported Event|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82850|NCT01684566|E1|Reported Event|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
82851|NCT01684436|B1|Baseline|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82852|NCT01684436|P1|Participant Flow|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82853|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82854|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82855|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82856|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82857|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82858|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82859|NCT01684436|E1|Reported Event|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
82860|NCT01684410|B4|Baseline|Total|Total of all reporting groups
82861|NCT01684410|B3|Baseline|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82862|NCT01684410|B2|Baseline|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82863|NCT01684410|B1|Baseline|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82864|NCT01684410|P3|Participant Flow|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82865|NCT01684410|P2|Participant Flow|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82866|NCT01684410|P1|Participant Flow|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82867|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82868|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82869|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82919|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82871|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82872|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82873|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82874|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82875|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82876|NCT01684410|E3|Reported Event|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
82877|NCT01684410|E2|Reported Event|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82878|NCT01684410|E1|Reported Event|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
82879|NCT01684046|B1|Baseline|PureMoist / RevitaLens|Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
82880|NCT01684046|P2|Participant Flow|RevitaLens - PureMoist|RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
82881|NCT01684046|P1|Participant Flow|PureMoist - RevitaLens|Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
82882|NCT01684046|O2|Outcome|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82883|NCT01684046|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82884|NCT01684046|E2|Reported Event|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82885|NCT01684046|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82886|NCT01684033|B1|Baseline|PureMoist / Biotrue|Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
82887|NCT01684033|P2|Participant Flow|Biotrue - PureMoist|Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
82888|NCT01684033|P1|Participant Flow|PureMoist - Biotrue|Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
82889|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82890|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82891|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82892|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82893|NCT01684033|E2|Reported Event|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82894|NCT01684033|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
82895|NCT01684007|B3|Baseline|Total|Total of all reporting groups
82896|NCT01684007|B2|Baseline|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
82897|NCT01684007|B1|Baseline|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
82898|NCT01684007|P2|Participant Flow|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
82899|NCT01684007|P1|Participant Flow|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
82900|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
82901|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
82902|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
82903|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
82904|NCT01684007|E2|Reported Event|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
82905|NCT01684007|E1|Reported Event|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
82906|NCT01683838|B3|Baseline|Total|Total of all reporting groups
82907|NCT01683838|B2|Baseline|Placebo|Placebo : Placebo
82908|NCT01683838|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82909|NCT01683838|P2|Participant Flow|Placebo|Placebo : Placebo
82910|NCT01683838|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82911|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82912|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82913|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82914|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82915|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
82930|NCT01683838|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
82931|NCT01683630|B3|Baseline|Total|Total of all reporting groups
82932|NCT01683630|B2|Baseline|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82933|NCT01683630|B1|Baseline|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82934|NCT01683630|P2|Participant Flow|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82935|NCT01683630|P1|Participant Flow|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82936|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82937|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82938|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82939|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82940|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82941|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82942|NCT01683630|E2|Reported Event|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
82943|NCT01683630|E1|Reported Event|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
82944|NCT01683604|B1|Baseline|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82945|NCT01683604|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82946|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82947|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82948|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82949|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82950|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82951|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82952|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82953|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82954|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82955|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82956|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82957|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82958|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82959|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82960|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82961|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82962|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82963|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82964|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82996|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82965|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82966|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82967|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82968|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82969|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82970|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82971|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82972|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82973|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82974|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82975|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82976|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82977|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82978|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82979|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82980|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82981|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82982|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82983|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82984|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82985|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82986|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82987|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82988|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82989|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82990|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82991|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82992|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82993|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82994|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82995|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82997|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
82998|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
82999|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83000|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83001|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83002|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83003|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83004|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83005|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83006|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83007|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83008|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83009|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83010|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83011|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83012|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83013|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83014|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83015|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83016|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83017|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83018|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83019|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83020|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83021|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83022|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83023|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83024|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83025|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83026|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83027|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83028|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83029|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83030|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83031|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83032|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83033|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83034|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83035|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83036|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83037|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83038|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83039|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83040|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83041|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83042|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83043|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83044|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83045|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83046|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83047|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83048|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83049|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83050|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83051|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83052|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83053|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83054|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83055|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83056|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83057|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83058|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83059|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83060|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83061|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83062|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83063|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83064|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83065|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83066|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83067|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83068|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83069|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83070|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83071|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83072|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83073|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83074|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83075|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83076|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83077|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83078|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83079|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83080|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83081|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83082|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83083|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83084|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83085|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83086|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83087|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83088|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83089|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83090|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83091|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83092|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83093|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83094|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83095|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83096|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83097|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83098|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83099|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83100|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83101|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83102|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83103|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
83104|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83105|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83106|NCT01683604|E1|Reported Event|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
83107|NCT01683526|B3|Baseline|Total|Total of all reporting groups
83108|NCT01683526|B2|Baseline|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83109|NCT01683526|B1|Baseline|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83110|NCT01683526|P2|Participant Flow|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83111|NCT01683526|P1|Participant Flow|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83112|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83113|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83114|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83115|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83116|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83117|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83118|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83119|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83120|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83121|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83122|NCT01683526|E2|Reported Event|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
83123|NCT01683526|E1|Reported Event|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
83124|NCT01683383|B3|Baseline|Total|Total of all reporting groups
83125|NCT01683383|B2|Baseline|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
83126|NCT01683383|B1|Baseline|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
83127|NCT01683383|P2|Participant Flow|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
83128|NCT01683383|P1|Participant Flow|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
83129|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83130|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83131|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83132|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83133|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83134|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83135|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83136|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83137|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83138|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83139|NCT01683383|E2|Reported Event|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
83140|NCT01683383|E1|Reported Event|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
83141|NCT01683266|B3|Baseline|Total|Total of all reporting groups
83142|NCT01683266|B2|Baseline|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83143|NCT01683266|B1|Baseline|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83144|NCT01683266|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
83145|NCT01683266|P1|Participant Flow|HOE901­-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
83146|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83147|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83148|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83149|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83150|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83151|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83152|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83153|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83154|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83155|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83156|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83157|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83158|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83159|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83160|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83161|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83162|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83163|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83164|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83165|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83166|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83167|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83168|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83169|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83170|NCT01683266|E2|Reported Event|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83171|NCT01683266|E1|Reported Event|HOE901-­U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
83172|NCT01683058|B1|Baseline|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83173|NCT01683058|P1|Participant Flow|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83174|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83175|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83176|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83177|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83178|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83179|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83180|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83181|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83182|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83183|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83184|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83185|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83186|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83187|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83188|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83189|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83190|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83191|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83192|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83193|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83194|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83195|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83196|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83197|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83198|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83199|NCT01683058|E1|Reported Event|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
83200|NCT01683019|B4|Baseline|Total|Total of all reporting groups
83201|NCT01683019|B3|Baseline|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
83202|NCT01683019|B2|Baseline|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83203|NCT01683019|B1|Baseline|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83204|NCT01683019|P3|Participant Flow|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
83245|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83246|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83205|NCT01683019|P2|Participant Flow|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83206|NCT01683019|P1|Participant Flow|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83207|NCT01683019|O3|Outcome|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
83208|NCT01683019|O2|Outcome|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83209|NCT01683019|O1|Outcome|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83210|NCT01683019|E3|Reported Event|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
83211|NCT01683019|E2|Reported Event|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83212|NCT01683019|E1|Reported Event|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
83213|NCT01682954|B3|Baseline|Total|Total of all reporting groups
83214|NCT01682954|B2|Baseline|Usual Care|Usual care from primary care physician
83215|NCT01682954|B1|Baseline|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
83216|NCT01682954|P2|Participant Flow|Usual Care|Usual care from primary care physician
83217|NCT01682954|P1|Participant Flow|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
83218|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
83219|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
83220|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
83221|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
83222|NCT01682954|E2|Reported Event|Usual Care|Usual care from primary care physician
83223|NCT01682954|E1|Reported Event|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
83224|NCT01682876|B5|Baseline|Total|Total of all reporting groups
83225|NCT01682876|B4|Baseline|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83226|NCT01682876|B3|Baseline|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83227|NCT01682876|B2|Baseline|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83228|NCT01682876|B1|Baseline|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83229|NCT01682876|P4|Participant Flow|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83230|NCT01682876|P3|Participant Flow|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83231|NCT01682876|P2|Participant Flow|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83232|NCT01682876|P1|Participant Flow|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83233|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83234|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83235|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83236|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83237|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83238|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83239|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83240|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83241|NCT01682876|O2|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83242|NCT01682876|O1|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83243|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83244|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83247|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83248|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83249|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83250|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83251|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83252|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83253|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83254|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83255|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83256|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83257|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83258|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83259|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83260|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83261|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83262|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83263|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83264|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83265|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83266|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83267|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83268|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83269|NCT01682876|E5|Reported Event|Total|Total Population
83270|NCT01682876|E4|Reported Event|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
83271|NCT01682876|E3|Reported Event|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
83272|NCT01682876|E2|Reported Event|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
83273|NCT01682876|E1|Reported Event|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
83274|NCT01682863|B4|Baseline|Total|Total of all reporting groups
83275|NCT01682863|B3|Baseline|QAB149 75 ug od|
83276|NCT01682863|B2|Baseline|QVA149 27.5/25 ug Bid|
83277|NCT01682863|B1|Baseline|QVA149 27.5/12.5 ug Bid|
83278|NCT01682863|P3|Participant Flow|QAB149 75 ug od|
83279|NCT01682863|P2|Participant Flow|QVA149 27.5/25 ug Bid|
83280|NCT01682863|P1|Participant Flow|QVA149 27.5/12.5 ug Bid|
83281|NCT01682863|O3|Outcome|QAB149 75 ug od|
83282|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83283|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83284|NCT01682863|O3|Outcome|QAB149 75 ug od|
83285|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83286|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83287|NCT01682863|O3|Outcome|QAB149 75 ug od|
83288|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83289|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83290|NCT01682863|O3|Outcome|QAB149 75 ug od|
83291|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83292|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83293|NCT01682863|O3|Outcome|QAB149 75 ug od|
83294|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83295|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83296|NCT01682863|O3|Outcome|QAB149 75 ug od|
83297|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83298|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83299|NCT01682863|O3|Outcome|QAB149 75 ug od|
83300|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83301|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83302|NCT01682863|O3|Outcome|QAB149 75 ug od|
83303|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
83304|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
83305|NCT01682863|E3|Reported Event|QAB75|QVA149 27.5/25 μg capsules
83306|NCT01682863|E2|Reported Event|QVA149 27.5/25 ug Bid|
83307|NCT01682863|E1|Reported Event|QVA149 27.5/12.5 ug Bid|
83308|NCT01682759|B3|Baseline|Total|Total of all reporting groups
83309|NCT01682759|B2|Baseline|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83310|NCT01682759|B1|Baseline|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83311|NCT01682759|P2|Participant Flow|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83312|NCT01682759|P1|Participant Flow|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83313|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83314|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83315|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83316|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83317|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83318|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83319|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83320|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83321|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83322|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83323|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83324|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83325|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83326|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83327|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83328|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83329|NCT01682759|E2|Reported Event|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
83330|NCT01682759|E1|Reported Event|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
83331|NCT01682720|B5|Baseline|Total|Total of all reporting groups
83332|NCT01682720|B4|Baseline|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83333|NCT01682720|B3|Baseline|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
83334|NCT01682720|B2|Baseline|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
83335|NCT01682720|B1|Baseline|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
83336|NCT01682720|P4|Participant Flow|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83337|NCT01682720|P3|Participant Flow|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
83338|NCT01682720|P2|Participant Flow|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
83339|NCT01682720|P1|Participant Flow|Placebo 12 Weeks (GT2/3)|Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
83340|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83341|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
83342|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
83343|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83344|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
83345|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
83346|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83347|NCT01682720|O2|Outcome|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
83348|NCT01682720|O1|Outcome|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
83349|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83350|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
83441|NCT01682135|B4|Baseline|Total|Total of all reporting groups
83351|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
83352|NCT01682720|E3|Reported Event|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
83353|NCT01682720|E2|Reported Event|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
83354|NCT01682720|E1|Reported Event|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
83355|NCT01682681|B1|Baseline|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83356|NCT01682681|P1|Participant Flow|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83357|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83358|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83359|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83360|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83361|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83362|NCT01682681|E1|Reported Event|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
83363|NCT01682642|B3|Baseline|Total|Total of all reporting groups
83364|NCT01682642|B2|Baseline|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83365|NCT01682642|B1|Baseline|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
83366|NCT01682642|P2|Participant Flow|Vaporization Only|After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
83367|NCT01682642|P1|Participant Flow|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
83368|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83369|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
83370|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
83371|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
83372|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
83373|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
83374|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83375|NCT01682642|O1|Outcome|Zoladex|
83376|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83377|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
83378|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83379|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
83380|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83381|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
83382|NCT01682642|E2|Reported Event|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
83383|NCT01682642|E1|Reported Event|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
83384|NCT01682603|B1|Baseline|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83385|NCT01682603|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A (BoNT-A) (BOTOX 300U)
83386|NCT01682603|O2|Outcome|Pre-Non Autonomic Dysreflexia|Baseline Non autonomic dysreflexia
83387|NCT01682603|O1|Outcome|Pre-Autonomic Dysreflexia|Baseline Autonomic dysreflexia
83388|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83389|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83390|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83391|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83392|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83393|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83394|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83395|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83396|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83397|NCT01682603|E1|Reported Event|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
83398|NCT01682538|B1|Baseline|Overall Study|All treatment arms
83399|NCT01682538|P1|Participant Flow|All Treatment Groups|"All participants received all study treatments in a randomized fashion. Subjects were allocated to one of the following treatment sequences (2 subjects to each sequence):~A B C; B C A; C A B; C B A; A C B; B A C where A=Orfadin capsules, single dose, 30 mg; B=Orfadin suspension, single dose 30 mg, fasting; C=Orfadin suspension, single dose 30 mg, fed"
83400|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83401|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83402|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83403|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83404|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension, 4 mg/mL, single dose, 30 mg (7.5 mL)
83405|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83406|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83407|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83408|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83409|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83410|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83411|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83412|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
83413|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
83414|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83415|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83416|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83417|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83418|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
83419|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
83420|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83421|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
83422|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83423|NCT01682538|E3|Reported Event|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83424|NCT01682538|E2|Reported Event|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
83425|NCT01682538|E1|Reported Event|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
83426|NCT01682460|B1|Baseline|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83427|NCT01682460|P1|Participant Flow|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83428|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83429|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83430|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83431|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83432|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83433|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83434|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83435|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83436|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83437|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83438|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83439|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83440|NCT01682460|E1|Reported Event|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
83442|NCT01682135|B3|Baseline|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83443|NCT01682135|B2|Baseline|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83444|NCT01682135|B1|Baseline|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83445|NCT01682135|P3|Participant Flow|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
83446|NCT01682135|P2|Participant Flow|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
83447|NCT01682135|P1|Participant Flow|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
83448|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83449|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83450|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83451|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83452|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83453|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83454|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83455|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83456|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83457|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83458|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83459|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83460|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83461|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83462|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83463|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83464|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83465|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83466|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83467|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83555|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
83468|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83469|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83470|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83471|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83472|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83473|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83474|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83475|NCT01682135|E3|Reported Event|Cohort 3 - 8mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
83476|NCT01682135|E2|Reported Event|Cohort 2 - 10mg/kg/3w Ramucirumab|10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
83477|NCT01682135|E1|Reported Event|Cohort 1 - 6mg/kg/2w Ramucirumab|6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
83478|NCT01682031|B3|Baseline|Total|Total of all reporting groups
83479|NCT01682031|B2|Baseline|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83480|NCT01682031|B1|Baseline|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83481|NCT01682031|P2|Participant Flow|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83482|NCT01682031|P1|Participant Flow|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83483|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83484|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83485|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83486|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83487|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83488|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83489|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83490|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83973|NCT01679028|P1|Participant Flow|Placebo Group A|Placebo 150mg single dose
83491|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83492|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83493|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83494|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83495|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83496|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83497|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83498|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83499|NCT01682031|E2|Reported Event|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83500|NCT01682031|E1|Reported Event|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
83501|NCT01681576|B3|Baseline|Total|Total of all reporting groups
83502|NCT01681576|B2|Baseline|Valsartan 320mg|Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
83503|NCT01681576|B1|Baseline|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
83504|NCT01681576|P2|Participant Flow|Valsartan Followed by LCZ696|Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
83505|NCT01681576|P1|Participant Flow|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
83506|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
83507|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
83508|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
83509|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
83510|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
83511|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
83512|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
83513|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
83514|NCT01681576|O2|Outcome|Valsartan -ALL|Valsartan 320mg QD
83515|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg QD
83516|NCT01681576|E2|Reported Event|Valsartan 320 mg QD|Valsartan 320 mg QD
83517|NCT01681576|E1|Reported Event|LCZ696 400 mg QD|LCZ696 400 mg QD
83518|NCT01681511|B3|Baseline|Total|Total of all reporting groups
83519|NCT01681511|B2|Baseline|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83520|NCT01681511|B1|Baseline|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83521|NCT01681511|P2|Participant Flow|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83522|NCT01681511|P1|Participant Flow|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83523|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83524|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83525|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83526|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83527|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83528|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83529|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83530|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83531|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83532|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83533|NCT01681511|E2|Reported Event|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
83534|NCT01681511|E1|Reported Event|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
83535|NCT01681472|B5|Baseline|Total|Total of all reporting groups
83536|NCT01681472|B4|Baseline|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83537|NCT01681472|B3|Baseline|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83538|NCT01681472|B2|Baseline|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
83539|NCT01681472|B1|Baseline|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
83540|NCT01681472|P4|Participant Flow|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83541|NCT01681472|P3|Participant Flow|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83542|NCT01681472|P2|Participant Flow|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
83543|NCT01681472|P1|Participant Flow|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
83544|NCT01681472|O4|Outcome|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83545|NCT01681472|O3|Outcome|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83546|NCT01681472|O2|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
83547|NCT01681472|O1|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
83548|NCT01681472|E4|Reported Event|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83549|NCT01681472|E3|Reported Event|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
83550|NCT01681472|E2|Reported Event|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
83551|NCT01681472|E1|Reported Event|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
83552|NCT01681368|B1|Baseline|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
83553|NCT01681368|P1|Participant Flow|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
83554|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
83556|NCT01681368|E1|Reported Event|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
83557|NCT01681277|B6|Baseline|Total|Total of all reporting groups
83558|NCT01681277|B5|Baseline|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83559|NCT01681277|B4|Baseline|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83560|NCT01681277|B3|Baseline|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83561|NCT01681277|B2|Baseline|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83562|NCT01681277|B1|Baseline|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
83563|NCT01681277|P5|Participant Flow|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83564|NCT01681277|P4|Participant Flow|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83565|NCT01681277|P3|Participant Flow|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83566|NCT01681277|P2|Participant Flow|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83567|NCT01681277|P1|Participant Flow|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
83568|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83569|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83570|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83571|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83572|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83573|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83574|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83755|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83575|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83576|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83577|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83578|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83579|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83580|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83581|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83582|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83583|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83584|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83585|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83586|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83587|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83588|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83589|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83590|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83591|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83592|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83756|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83593|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83594|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83595|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83596|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
83597|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83598|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83599|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83600|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83601|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
83602|NCT01681277|E5|Reported Event|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
83603|NCT01681277|E4|Reported Event|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83604|NCT01681277|E3|Reported Event|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83605|NCT01681277|E2|Reported Event|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
83606|NCT01681277|E1|Reported Event|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
83607|NCT01681212|B1|Baseline|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83608|NCT01681212|P1|Participant Flow|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression, unacceptable toxicity, or withdrawal of consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83757|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83609|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83610|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83611|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83612|NCT01681212|E1|Reported Event|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
83613|NCT01681121|B3|Baseline|Total|Total of all reporting groups
83614|NCT01681121|B2|Baseline|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
83615|NCT01681121|B1|Baseline|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
83616|NCT01681121|P2|Participant Flow|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
83617|NCT01681121|P1|Participant Flow|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
83618|NCT01681121|O2|Outcome|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
83619|NCT01681121|O1|Outcome|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
83620|NCT01681121|E2|Reported Event|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
83621|NCT01681121|E1|Reported Event|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
83622|NCT01681069|B3|Baseline|Total|Total of all reporting groups
83623|NCT01681069|B2|Baseline|Placebo|"2 tablets twice a day~Placebo"
83624|NCT01681069|B1|Baseline|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83625|NCT01681069|P2|Participant Flow|Placebo|"2 tablets twice a day~Placebo"
83626|NCT01681069|P1|Participant Flow|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83627|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
83628|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83629|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
83630|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83631|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
83632|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83633|NCT01681069|E2|Reported Event|Placebo|"2 tablets twice a day~Placebo"
83634|NCT01681069|E1|Reported Event|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
83635|NCT01680991|B4|Baseline|Total|Total of all reporting groups
83636|NCT01680991|B3|Baseline|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83637|NCT01680991|B2|Baseline|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83638|NCT01680991|B1|Baseline|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83639|NCT01680991|P3|Participant Flow|FL: 1000 mg Obinutuzumab|Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83758|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83974|NCT01679028|O6|Outcome|T89 Group C|T89 225mg bid for 10 days
83640|NCT01680991|P2|Participant Flow|DLBCL: 1000 mg Obinutuzumab|Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83641|NCT01680991|P1|Participant Flow|CLL: 1000 mg Obinutuzumab|Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83642|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83643|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83644|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83645|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83646|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83647|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83648|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83649|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83650|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83651|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83652|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83653|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83654|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83655|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83656|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83657|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83658|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83659|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83660|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83661|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83662|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83759|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83975|NCT01679028|O5|Outcome|Placebo Group C|225mg bid for 10 days
83663|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83664|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83665|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83666|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83667|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83668|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83669|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83670|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83671|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83672|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83673|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83674|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83675|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83676|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83677|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83678|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83679|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83680|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83681|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83682|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83683|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83684|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83685|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83686|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83687|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83760|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83688|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83689|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83690|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83691|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83692|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83693|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83694|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83695|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83696|NCT01680991|E3|Reported Event|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83697|NCT01680991|E2|Reported Event|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
83698|NCT01680991|E1|Reported Event|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
83699|NCT01680900|B3|Baseline|Total|Total of all reporting groups
83700|NCT01680900|B2|Baseline|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83701|NCT01680900|B1|Baseline|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83702|NCT01680900|P2|Participant Flow|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83703|NCT01680900|P1|Participant Flow|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83704|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83705|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83706|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83707|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83708|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83709|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83710|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83711|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83712|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83713|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83714|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83715|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83716|NCT01680900|E2|Reported Event|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
83761|NCT01680497|E1|Reported Event|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83717|NCT01680900|E1|Reported Event|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
83718|NCT01680861|B3|Baseline|Total|Total of all reporting groups
83719|NCT01680861|B2|Baseline|Tacrolimus/EC-MPS|our standard maintenance arm.
83720|NCT01680861|B1|Baseline|Tacrolimus/Everolimus|our experimental maintenance arm.
83721|NCT01680861|P2|Participant Flow|Tacrolimus/EC-MPS|our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).
83722|NCT01680861|P1|Participant Flow|Tacrolimus/Everolimus|our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
83723|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
83724|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
83725|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
83726|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
83727|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
83728|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
83729|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
83730|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
83731|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
83732|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
83733|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
83734|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
83735|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
83736|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
83737|NCT01680861|E2|Reported Event|Tacrolimus/EC-MPS|our standard maintenance arm
83738|NCT01680861|E1|Reported Event|Tacrolimus/Everolimus|our experimental maintenance arm
83739|NCT01680848|B1|Baseline|JDPBRN Dentists|"Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.~The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website."
83740|NCT01680848|P1|Participant Flow|JDPBRN Dentists|Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
83741|NCT01680848|O1|Outcome|High Caries Risk|The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.
83742|NCT01680848|E1|Reported Event|This is an Observational Study|This is an observational study. We don't have two arms.
83743|NCT01680666|B3|Baseline|Total|Total of all reporting groups
83744|NCT01680666|B2|Baseline|Ultrasound Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
83745|NCT01680666|B1|Baseline|Landmark Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
83746|NCT01680666|P2|Participant Flow|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
83747|NCT01680666|P1|Participant Flow|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
83748|NCT01680666|O2|Outcome|Ultrasound Guided|Success of central venous cannulation at first attempt
83749|NCT01680666|O1|Outcome|Landmark Technique|Success of central venous cannulation at first attempt
83750|NCT01680666|E2|Reported Event|Ultrasound|Success of central venous cannulation at first attempt
83751|NCT01680666|E1|Reported Event|Landmark|Success of central venous cannulation at first attempt
83752|NCT01680497|B1|Baseline|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83753|NCT01680497|P1|Participant Flow|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83754|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
83976|NCT01679028|O4|Outcome|T89 Group B|300mg T89; single dose
83762|NCT01680458|B1|Baseline|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83763|NCT01680458|P1|Participant Flow|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83764|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83765|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83766|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83767|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83768|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83769|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83770|NCT01680458|E1|Reported Event|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
83771|NCT01680341|B3|Baseline|Total|Total of all reporting groups
83772|NCT01680341|B2|Baseline|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83773|NCT01680341|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83774|NCT01680341|P2|Participant Flow|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83775|NCT01680341|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83776|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83777|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83778|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83779|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83780|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83810|NCT01680328|O1|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
83811|NCT01680328|O2|Outcome|Abdomen|Acceptance of pain was assessed in each subject for all injections in the abdomen.
83781|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83782|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83783|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83784|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83785|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83786|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83787|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83788|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83789|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83790|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83791|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83792|NCT01680341|E2|Reported Event|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
83812|NCT01680328|O1|Outcome|Thighs|Acceptance of pain was assessed in each subject for all injections in the thighs.
83813|NCT01680328|O3|Outcome|Injection Speed at 150 μL/s|Acceptance of pain was assessed in each subject for all injections.
83814|NCT01680328|O2|Outcome|Injection Speed at 300 μL/s|Acceptance of pain was assessed in each subject for all injections.
83793|NCT01680341|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
83794|NCT01680328|B1|Baseline|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
83795|NCT01680328|P1|Participant Flow|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
83796|NCT01680328|O7|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83797|NCT01680328|O6|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83798|NCT01680328|O5|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83799|NCT01680328|O4|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83800|NCT01680328|O3|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83801|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83802|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
83803|NCT01680328|O8|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83804|NCT01680328|O7|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83805|NCT01680328|O6|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83806|NCT01680328|O5|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83807|NCT01680328|O4|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83808|NCT01680328|O3|Outcome|Injection Volume 1200 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83809|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83815|NCT01680328|O1|Outcome|Injection Speed at 450 μL/s|Acceptance of pain was assessed in each subject for all injections.
83816|NCT01680328|O4|Outcome|Injection Volume of 400 μL|Acceptance of pain was assessed in each subject for all injections.
83817|NCT01680328|O3|Outcome|Injection Volume of 800 μL|Acceptance of pain was assessed in each subject for all injections.
83818|NCT01680328|O2|Outcome|Injection Volume of 1200 μL|Acceptance of pain was assessed in each subject for all injections.
83819|NCT01680328|O1|Outcome|Injection Volume of 1600 μL|Acceptance of pain was assessed in each subject for all injections.
83820|NCT01680328|O9|Outcome|Injection Speed at 150 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83821|NCT01680328|O8|Outcome|Injection Speed at 300 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83822|NCT01680328|O7|Outcome|Injection Speed at 450 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83823|NCT01680328|O6|Outcome|Injection Volume 400 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83824|NCT01680328|O5|Outcome|Injection Volume 800 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83825|NCT01680328|O4|Outcome|Injection Volume 1200 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83826|NCT01680328|O3|Outcome|Injection Volume 1600 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
83827|NCT01680328|O2|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
83828|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
83829|NCT01680328|E1|Reported Event|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
83830|NCT01680172|B3|Baseline|Total|Total of all reporting groups
83831|NCT01680172|B2|Baseline|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
83832|NCT01680172|B1|Baseline|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
83833|NCT01680172|P2|Participant Flow|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
83834|NCT01680172|P1|Participant Flow|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
83835|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
83836|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
83837|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
83838|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
83839|NCT01680172|E2|Reported Event|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
83840|NCT01680172|E1|Reported Event|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
83841|NCT01680016|B3|Baseline|Total|Total of all reporting groups
83842|NCT01680016|B2|Baseline|Essen|Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83843|NCT01680016|B1|Baseline|Zagreb|Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83844|NCT01680016|P4|Participant Flow|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83845|NCT01680016|P3|Participant Flow|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83846|NCT01680016|P2|Participant Flow|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83847|NCT01680016|P1|Participant Flow|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
83848|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83849|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83850|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83851|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
83852|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83853|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83854|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83855|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83856|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83857|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83858|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83859|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83860|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83861|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83862|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83863|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83864|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83865|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83866|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83867|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83868|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83869|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83870|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83871|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83872|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83873|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83874|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83875|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83876|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83877|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83878|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83879|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83880|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83881|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83882|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83883|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83884|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83885|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83886|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83887|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83888|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83889|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83890|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83977|NCT01679028|O3|Outcome|Placebo Group B|300mg Placebo; single dose
83891|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83892|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83893|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83894|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83895|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83896|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83897|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83898|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83899|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83900|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83901|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
83902|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
83903|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
83904|NCT01680016|E4|Reported Event|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
83905|NCT01680016|E3|Reported Event|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83906|NCT01680016|E2|Reported Event|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
83907|NCT01680016|E1|Reported Event|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
83908|NCT01679613|B1|Baseline|Overall Study|This was a randomised, open-label trial in healthy male subjects with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatments (A and B) given in 1 of the 2 treatment sequences (A_B and B_A) or in the Main part with also 2 treatments (C and D) given in 1 of the 2 treatment sequences (C_D and D_C). Nintedanib administrations of the 2 respective treatments (A and B or C and D) were to be separated by a wash-out period of at least 14 days. The Pilot part was separated from the Main part by at least 3 weeks to allow for interim analysis
83909|NCT01679613|P4|Participant Flow|Nintedanib+Ketoconazole (Main Part)/ Nintedanib (Main Part)|Ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose, based on the results from the Pilot part (Treatment C).
83910|NCT01679613|P3|Participant Flow|Nintedanib (Main Part)/ Nintedanib+Ketoconazole (Main Part)|Based on the results from the Pilot part, nintedanib 50mg was given as a single dose (Treatment C). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D)
83911|NCT01679613|P2|Participant Flow|Nintedanib+Ketoconazole (Pilot Part)/ Nintedanib (Pilot Part)|Ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose (Treatment A).
83912|NCT01679613|P1|Participant Flow|Nintedanib (Pilot Part)/ Nintedanib+Ketoconazole (Pilot Part)|Nintedanib 50mg was given as a single dose (Treatment A). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B)
83913|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83914|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83915|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83950|NCT01679314|E2|Reported Event|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83916|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83917|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83918|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83919|NCT01679613|E3|Reported Event|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83920|NCT01679613|E2|Reported Event|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
83921|NCT01679613|E1|Reported Event|Ketoconazole|In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2
83922|NCT01679600|B3|Baseline|Total|Total of all reporting groups
83923|NCT01679600|B2|Baseline|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
83924|NCT01679600|B1|Baseline|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
83925|NCT01679600|P2|Participant Flow|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
83926|NCT01679600|P1|Participant Flow|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
83927|NCT01679600|O2|Outcome|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
83928|NCT01679600|O1|Outcome|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
83929|NCT01679600|E2|Reported Event|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
83930|NCT01679600|E1|Reported Event|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
83931|NCT01679314|B3|Baseline|Total|Total of all reporting groups
83932|NCT01679314|B2|Baseline|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83933|NCT01679314|B1|Baseline|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83934|NCT01679314|P2|Participant Flow|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83935|NCT01679314|P1|Participant Flow|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83936|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83937|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83938|NCT01679314|O2|Outcome|Sham AlphaCore Device|"Sham AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
83939|NCT01679314|O1|Outcome|Active AlphaCore Device|"Active AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
83940|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83941|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83942|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83943|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83944|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83945|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83946|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83947|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
83948|NCT01679314|O2|Outcome|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83949|NCT01679314|O1|Outcome|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83951|NCT01679314|E1|Reported Event|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
83952|NCT01679236|B3|Baseline|Total|Total of all reporting groups
83953|NCT01679236|B2|Baseline|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
83954|NCT01679236|B1|Baseline|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
83955|NCT01679236|P2|Participant Flow|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
83956|NCT01679236|P1|Participant Flow|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
83957|NCT01679236|O2|Outcome|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
83958|NCT01679236|O1|Outcome|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
83959|NCT01679236|E2|Reported Event|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
83960|NCT01679236|E1|Reported Event|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
83961|NCT01679028|B7|Baseline|Total|Total of all reporting groups
83962|NCT01679028|B6|Baseline|T89 Group C|T89 225mg bid for 14 days
83963|NCT01679028|B5|Baseline|Placebo Group C|Placebo 225mg bid for 14 days
83964|NCT01679028|B4|Baseline|T89 Group B|T89 300mg single dose
83965|NCT01679028|B3|Baseline|Placebo Group B|Placebo 300mg single dose
83966|NCT01679028|B2|Baseline|T89 Group A|T89 150mg single dose
83967|NCT01679028|B1|Baseline|Placebo Group A|Placebo 150mg single dose
83968|NCT01679028|P6|Participant Flow|T89 Group C|T89 225mg bid for 14 days
83969|NCT01679028|P5|Participant Flow|Placebo Group C|Placebo 225mg bid for 14 days
83970|NCT01679028|P4|Participant Flow|T89 Group B|T89 300mg single dose
83971|NCT01679028|P3|Participant Flow|Placebo Group B|Placebo 300mg single dose
83972|NCT01679028|P2|Participant Flow|T89 Group A|T89 150mg single dose
83981|NCT01679028|E5|Reported Event|Placebo Group C|Placebo 225mg bid for 14 days
83982|NCT01679028|E4|Reported Event|T89 Group B|300mg T89 single dose
83983|NCT01679028|E3|Reported Event|Placebo Group B|300mg Placebo single dose
83984|NCT01679028|E2|Reported Event|T89 Group A|150mg T89 single dose
83985|NCT01679028|E1|Reported Event|Placebo Group A|150 mg Placebo Single dose
83986|NCT01679002|B4|Baseline|Total|Total of all reporting groups
83987|NCT01679002|B3|Baseline|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
83988|NCT01679002|B2|Baseline|Group B|BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
83989|NCT01679002|B1|Baseline|Group A|BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
83990|NCT01679002|P3|Participant Flow|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
83991|NCT01679002|P2|Participant Flow|Group B|"BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period~BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od"
83992|NCT01679002|P1|Participant Flow|Group A|"BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.~BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid"
83993|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
83994|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
83995|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
83996|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
83997|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
83998|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
83999|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
84000|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
84001|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
84002|NCT01679002|E3|Reported Event|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
84003|NCT01679002|E2|Reported Event|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
84004|NCT01679002|E1|Reported Event|BIA 2-093 900 mg|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
84005|NCT01678976|B3|Baseline|Total|Total of all reporting groups
84006|NCT01678976|B2|Baseline|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
84007|NCT01678976|B1|Baseline|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
84008|NCT01678976|P2|Participant Flow|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
84009|NCT01678976|P1|Participant Flow|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
84010|NCT01678976|O2|Outcome|Oxcarbazepine|Oxcarbazepine, Trileptal
84011|NCT01678976|O1|Outcome|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
84012|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
84013|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL, Eslicarbazepine acetate
84014|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
84015|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL Eslicarbazepine acetate
84016|NCT01678976|E2|Reported Event|Oxcarbazepine|Oxcarbazepine, Trileptal
84017|NCT01678976|E1|Reported Event|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
84018|NCT01678911|B1|Baseline|All Subjects|All randomized subjects
84019|NCT01678911|P2|Participant Flow|Gralise Then Placebo|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
84020|NCT01678911|P1|Participant Flow|Placebo, Then Gralise|Subjects may receive a pill with no medicine.
84021|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
84022|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
84023|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
84024|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
84025|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
84026|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
84027|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
84028|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
84029|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
84030|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
84031|NCT01678911|E2|Reported Event|Gralise|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
84032|NCT01678911|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
84033|NCT01678885|B1|Baseline|All Participants|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
84034|NCT01678885|P3|Participant Flow|Phase 2- Low-Calorie Diet|Participants who complete Phase I (either group 1 or group 2) of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan is a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants will complete in a free-living environment. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
84035|NCT01678885|P2|Participant Flow|Phase 1- IDEEA First, Then Digital Photography of Foods|Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
84036|NCT01678885|P1|Participant Flow|Phase 1- Digital Photography of Foods First, Then IDEEA|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.
84037|NCT01678885|O1|Outcome|Phase II|Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.
84038|NCT01678885|O1|Outcome|Phase 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
84039|NCT01678885|E1|Reported Event|Energy Balance|
84040|NCT01678846|B3|Baseline|Total|Total of all reporting groups
84041|NCT01678846|B2|Baseline|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84042|NCT01678846|B1|Baseline|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84043|NCT01678846|P2|Participant Flow|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84044|NCT01678846|P1|Participant Flow|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84045|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84060|NCT01678820|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84130|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84046|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84047|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84048|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84049|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84050|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84051|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84052|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84053|NCT01678846|E2|Reported Event|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
84054|NCT01678846|E1|Reported Event|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
84055|NCT01678820|B4|Baseline|Total|Total of all reporting groups
84056|NCT01678820|B3|Baseline|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84057|NCT01678820|B2|Baseline|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84058|NCT01678820|B1|Baseline|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84059|NCT01678820|P3|Participant Flow|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84061|NCT01678820|P1|Participant Flow|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84062|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84063|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84064|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84065|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84066|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84067|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84068|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84069|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84070|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84071|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84072|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84073|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84074|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84075|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84076|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84125|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
84126|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84077|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84078|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84079|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84080|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84081|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84082|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84083|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84084|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84085|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84086|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84087|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84088|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84089|NCT01678820|O2|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84090|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84091|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84092|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84127|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
84128|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84093|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84094|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84095|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84096|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84097|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84098|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84099|NCT01678820|E3|Reported Event|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84100|NCT01678820|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84101|NCT01678820|E1|Reported Event|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
84102|NCT01678807|B4|Baseline|Total|Total of all reporting groups
84103|NCT01678807|B3|Baseline|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
84104|NCT01678807|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
84105|NCT01678807|B1|Baseline|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
84106|NCT01678807|P3|Participant Flow|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
84107|NCT01678807|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
84108|NCT01678807|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
84109|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
84110|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
84111|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
84112|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
84113|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
84114|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
84115|NCT01678807|E3|Reported Event|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
84116|NCT01678807|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
84117|NCT01678807|E1|Reported Event|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
84118|NCT01678313|B3|Baseline|Total|Total of all reporting groups
84119|NCT01678313|B2|Baseline|Control Group|Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
84120|NCT01678313|B1|Baseline|Study Group|Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
84121|NCT01678313|P2|Participant Flow|Control Group|Doxazosin 4 mg every day (QD)
84122|NCT01678313|P1|Participant Flow|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84123|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
84124|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84132|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84133|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
84134|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84135|NCT01678313|E2|Reported Event|Control Group|Doxazosin 4 mg every day (QD)
84136|NCT01678313|E1|Reported Event|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
84137|NCT01678196|B3|Baseline|Total|Total of all reporting groups
84138|NCT01678196|B2|Baseline|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84139|NCT01678196|B1|Baseline|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84140|NCT01678196|P2|Participant Flow|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84141|NCT01678196|P1|Participant Flow|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84142|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84143|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84144|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84145|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84146|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84147|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84148|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84149|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84150|NCT01678196|E2|Reported Event|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
84151|NCT01678196|E1|Reported Event|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
84152|NCT01678131|B4|Baseline|Total|Total of all reporting groups
84153|NCT01678131|B3|Baseline|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84154|NCT01678131|B2|Baseline|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84155|NCT01678131|B1|Baseline|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
84156|NCT01678131|P3|Participant Flow|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84157|NCT01678131|P2|Participant Flow|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84158|NCT01678131|P1|Participant Flow|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
84159|NCT01678131|O3|Outcome|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84417|NCT01676298|O2|Outcome|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84160|NCT01678131|O2|Outcome|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84161|NCT01678131|O1|Outcome|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84162|NCT01678131|E3|Reported Event|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84163|NCT01678131|E2|Reported Event|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
84164|NCT01678131|E1|Reported Event|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
84165|NCT01677988|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84166|NCT01677988|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84167|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84168|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84169|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84170|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84171|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84172|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84173|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84174|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
84175|NCT01677988|E1|Reported Event|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
84176|NCT01677936|B3|Baseline|Total|Total of all reporting groups
84177|NCT01677936|B2|Baseline|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
84178|NCT01677936|B1|Baseline|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
84179|NCT01677936|P2|Participant Flow|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
84180|NCT01677936|P1|Participant Flow|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
84181|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
84182|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
84183|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
84184|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
84187|NCT01677767|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84188|NCT01677767|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84189|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
84190|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84191|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84192|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84193|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84194|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84195|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
84196|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
84197|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84198|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84199|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84200|NCT01677767|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
84201|NCT01677624|B1|Baseline|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
84202|NCT01677624|P1|Participant Flow|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
84203|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
84204|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
84205|NCT01677624|E1|Reported Event|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
84206|NCT01677299|B5|Baseline|Total|Total of all reporting groups
84207|NCT01677299|B4|Baseline|Sequence DACB|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
84208|NCT01677299|B3|Baseline|Sequence CDBA|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
84209|NCT01677299|B2|Baseline|Sequence ABDC|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
84210|NCT01677299|B1|Baseline|Sequence BCAD|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
84211|NCT01677299|P4|Participant Flow|Sequence 4: DACB|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
84212|NCT01677299|P3|Participant Flow|Sequence 3: CDBA|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
84213|NCT01677299|P2|Participant Flow|Sequence 2: ABDC|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
84214|NCT01677299|P1|Participant Flow|Sequence 1: BCAD|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
84215|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
84216|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84217|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84218|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
84219|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
84220|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84221|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84222|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
84223|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
84224|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84225|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
84226|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
84227|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|BID
84228|NCT01677299|O3|Outcome|500 mg EFB0027|BID
84229|NCT01677299|O2|Outcome|1000 mg EFB0027|BID
84230|NCT01677299|O1|Outcome|1000 mg EFB0026|BID
84231|NCT01677299|E4|Reported Event|500 mg EFB0026 BID Plus 1000 mg EFB0027 BID|D: Metformin immediate plus Metformin delayed release
84232|NCT01677299|E3|Reported Event|500 mg EFB0027 BID|C: Metformin delayed release BID
84233|NCT01677299|E2|Reported Event|1000 mg EFB0027 BID|B: Metformin delayed release BID
84234|NCT01677299|E1|Reported Event|1000 mg EFB0026 BID|A: Metformin immediate release BID
84235|NCT01677195|B4|Baseline|Total|Total of all reporting groups
84236|NCT01677195|B3|Baseline|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
84237|NCT01677195|B2|Baseline|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84238|NCT01677195|B1|Baseline|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84239|NCT01677195|P3|Participant Flow|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
84240|NCT01677195|P2|Participant Flow|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84241|NCT01677195|P1|Participant Flow|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84242|NCT01677195|O3|Outcome|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
84243|NCT01677195|O2|Outcome|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84244|NCT01677195|O1|Outcome|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84245|NCT01677195|E3|Reported Event|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
84298|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84418|NCT01676298|O1|Outcome|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84246|NCT01677195|E2|Reported Event|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84247|NCT01677195|E1|Reported Event|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
84248|NCT01677182|B4|Baseline|Total|Total of all reporting groups
84249|NCT01677182|B3|Baseline|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84250|NCT01677182|B2|Baseline|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84251|NCT01677182|B1|Baseline|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84252|NCT01677182|P3|Participant Flow|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84253|NCT01677182|P2|Participant Flow|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84254|NCT01677182|P1|Participant Flow|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84255|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84256|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84257|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84258|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84259|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84260|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84261|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84262|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84263|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84264|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84265|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84266|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84267|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84268|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84269|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84270|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84271|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84272|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84273|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84274|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84275|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84276|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84277|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84278|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84279|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84280|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84281|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84282|NCT01677182|E3|Reported Event|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
84283|NCT01677182|E2|Reported Event|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
84284|NCT01677182|E1|Reported Event|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
84285|NCT01676896|B4|Baseline|Total|Total of all reporting groups
84286|NCT01676896|B3|Baseline|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84419|NCT01676298|E8|Reported Event|*2/*17 CYP2C19 Genotype|
84420|NCT01676298|E7|Reported Event|*2/*3 CYP2C19 Genotype|
84421|NCT01676298|E6|Reported Event|*17/*17 CYP2C19 Genotype|
84422|NCT01676298|E5|Reported Event|*1/*17 CYP2C19 Genotype|
84287|NCT01676896|B2|Baseline|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84288|NCT01676896|B1|Baseline|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84289|NCT01676896|P3|Participant Flow|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84290|NCT01676896|P2|Participant Flow|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84291|NCT01676896|P1|Participant Flow|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84292|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84293|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84294|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84295|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84296|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84297|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84423|NCT01676298|E4|Reported Event|*3/*1 CYP2C19 Genotype|
84424|NCT01676298|E3|Reported Event|*2/*2 CYP2C19 Genotype|
84425|NCT01676298|E2|Reported Event|*1/*2 CYP2C19 Genotype|
84299|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84300|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84301|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84302|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84303|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84304|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84305|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84306|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84307|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84308|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84309|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84426|NCT01676298|E1|Reported Event|*1/*1 CYP2C19 Genotype|
84427|NCT01676220|B3|Baseline|Total|Total of all reporting groups
84310|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84311|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84312|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84313|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84314|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84315|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84316|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84317|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84318|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84319|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84320|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84332|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84321|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84322|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84323|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84324|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84325|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84326|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84327|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84328|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84329|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84330|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84331|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84355|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
85827|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
84333|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84334|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84335|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84336|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84337|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84338|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84339|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84340|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84341|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84342|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84343|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84367|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
85828|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
84344|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84345|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84346|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84347|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84348|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84349|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84350|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84351|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84352|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84353|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84354|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84411|NCT01676298|O8|Outcome|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84412|NCT01676298|O7|Outcome|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84356|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84357|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84358|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84359|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84360|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84361|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84362|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84363|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84364|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84365|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84366|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84413|NCT01676298|O6|Outcome|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84414|NCT01676298|O5|Outcome|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84368|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84369|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84370|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84371|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84372|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84373|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84374|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84375|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84376|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84377|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84378|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84415|NCT01676298|O4|Outcome|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84416|NCT01676298|O3|Outcome|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84379|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84380|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84381|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84382|NCT01676896|E3|Reported Event|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
84383|NCT01676896|E2|Reported Event|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
84384|NCT01676896|E1|Reported Event|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
84385|NCT01676532|B1|Baseline|Students Attending SBHC|"Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.~Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC"
84386|NCT01676532|P1|Participant Flow|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
84387|NCT01676532|O1|Outcome|Sprucecourt Public School Vs Other Participating Schools|The number of students from the host school of the SBHC and other participating schools
84388|NCT01676532|O1|Outcome|Number of Students From Sprucecourt Who Enrolled in SBHC|From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated
84389|NCT01676532|O1|Outcome|Number of Referrals Made for Students Attending SBHC|Types and number of referrals made for students attending SBHC.
84390|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Diagnoses|Porportion of students attending SBHC with new diagnoses
84391|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Treatment Plans|The total number of students who attended SBHC that had new treatment plans proposed
84392|NCT01676532|O1|Outcome|Students Attending SBHC|Students who were enrolled at the SBHC and then attended the SBHC
84393|NCT01676532|E1|Reported Event|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
84394|NCT01676298|B9|Baseline|Total|Total of all reporting groups
84395|NCT01676298|B8|Baseline|*2/*17 CYP2C19 Genotype|
84396|NCT01676298|B7|Baseline|*2/*3 CYP2C19 Genotype|
84397|NCT01676298|B6|Baseline|*17/*17 CYP2C19 Genotype|
84398|NCT01676298|B5|Baseline|*1/*17 CYP2C19 Genotype|
84399|NCT01676298|B4|Baseline|*3/*1 CYP2C19 Genotype|
84400|NCT01676298|B3|Baseline|*2/*2 CYP2C19 Genotype|
84401|NCT01676298|B2|Baseline|*1/*2 CYP2C19 Genotype|
84402|NCT01676298|B1|Baseline|*1/*1 CYP2C19 Genotype|
84403|NCT01676298|P8|Participant Flow|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84404|NCT01676298|P7|Participant Flow|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84405|NCT01676298|P6|Participant Flow|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84406|NCT01676298|P5|Participant Flow|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84407|NCT01676298|P4|Participant Flow|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84408|NCT01676298|P3|Participant Flow|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84409|NCT01676298|P2|Participant Flow|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84410|NCT01676298|P1|Participant Flow|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
84428|NCT01676220|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84429|NCT01676220|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84430|NCT01676220|P2|Participant Flow|Lantus (Insulin Glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
84431|NCT01676220|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
84432|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84433|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84434|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84435|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84436|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84437|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84438|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84439|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84440|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
84441|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
84442|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84443|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84444|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84445|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84446|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84447|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84448|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84449|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84450|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84451|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84452|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84453|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84454|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84455|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84456|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84457|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
84458|NCT01676220|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
84459|NCT01676220|E1|Reported Event|HOE901-U300|HOE901­U300 SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
84460|NCT01676012|B1|Baseline|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
84461|NCT01676012|P1|Participant Flow|Five Types of Bronchoscopy|"Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
84462|NCT01676012|O1|Outcome|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
84463|NCT01676012|E1|Reported Event|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
84464|NCT01675830|B1|Baseline|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
84465|NCT01675830|P1|Participant Flow|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
84466|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
84467|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
84468|NCT01675830|E1|Reported Event|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
84469|NCT01675544|B1|Baseline|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
84470|NCT01675544|P1|Participant Flow|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
84471|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
84472|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
84473|NCT01675544|E1|Reported Event|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
84474|NCT01675531|B1|Baseline|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
84475|NCT01675531|P1|Participant Flow|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
84476|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
84477|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
84478|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
84479|NCT01675531|O1|Outcome|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
84480|NCT01675531|E1|Reported Event|Oxycodone/Naloxone|"Targin(Oxycodone/Naloxone)~Targin: Single arm for Targin"
84481|NCT01675453|B3|Baseline|Total|Total of all reporting groups
84482|NCT01675453|B2|Baseline|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
84483|NCT01675453|B1|Baseline|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
84484|NCT01675453|P2|Participant Flow|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
84485|NCT01675453|P1|Participant Flow|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
84486|NCT01675453|O2|Outcome|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
84487|NCT01675453|O1|Outcome|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
84488|NCT01675453|E2|Reported Event|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
84489|NCT01675453|E1|Reported Event|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
84490|NCT01675427|B1|Baseline|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
84491|NCT01675427|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
84492|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84493|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84494|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84495|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84496|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84497|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84498|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84499|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84500|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84501|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84502|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84503|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84504|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84505|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84506|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84507|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84508|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84509|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84510|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84511|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84512|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84513|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84514|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84515|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84516|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84517|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84518|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84519|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84520|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84521|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84522|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84523|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84524|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84525|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84526|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84527|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84528|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84529|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84530|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84531|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84532|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84533|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84534|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84535|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84536|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84537|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84538|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84539|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84540|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84541|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84542|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84543|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84544|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
85175|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
84545|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84546|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84547|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84548|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84549|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84550|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84551|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84552|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84553|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84554|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84555|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
84556|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
84557|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
84558|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84559|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84560|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84561|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 Alanine-Alanine (AA)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
84562|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 Alanine-Cysteine (AC)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
84563|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
84564|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84565|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84566|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84567|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84568|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84569|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84570|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84571|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84572|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84573|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84574|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84575|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84576|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84577|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84578|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84579|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84580|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84581|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84582|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84583|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84584|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84585|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84586|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84587|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84588|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84589|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84590|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84591|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84592|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84593|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84594|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84595|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84596|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84597|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84598|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84599|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84600|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84601|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84602|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84603|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84604|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84605|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84606|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84607|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84608|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84609|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84610|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84611|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84612|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84613|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84614|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84615|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84616|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84617|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84618|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84619|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84620|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84621|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84622|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84623|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84624|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84625|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84626|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84627|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84628|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84629|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84630|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84631|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84632|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84633|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84634|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84635|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84636|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84637|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84638|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84639|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84640|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84641|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84642|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84643|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84644|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84645|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84646|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84647|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84648|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84649|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84650|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84651|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84652|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84653|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84654|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84655|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84656|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84657|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84658|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84659|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84660|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84661|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84662|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84663|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84664|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84665|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84666|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84667|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84668|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84669|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84670|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84671|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84672|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84673|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84674|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84675|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84676|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84677|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84678|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84679|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84680|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84681|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84682|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84683|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84684|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84685|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84686|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84687|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84688|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84689|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84690|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84691|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84692|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84693|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84694|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84695|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84696|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84697|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84698|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84699|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84700|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84701|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84702|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84703|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84704|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84705|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84706|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84707|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84708|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84709|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84710|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84711|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84712|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84713|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84714|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84715|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84716|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84717|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84718|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84719|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84720|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84721|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84722|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84723|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84724|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84725|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84726|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84727|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84728|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84729|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84730|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84731|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84732|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84733|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84734|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84735|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84736|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84737|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84738|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84739|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84740|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84741|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84742|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84743|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84744|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84745|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84746|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84747|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84748|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84749|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84750|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84751|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84752|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84753|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84754|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84755|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84756|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84757|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84758|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84759|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84760|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84761|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84762|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84763|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84764|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84765|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 Glycine-Glycine (GG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
84766|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 Threonine-Glycine (TG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
84767|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
84768|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84769|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84770|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84771|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 Threonine-Threonine (TT)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
84772|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 Threonine-Cysteine (TC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
84773|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 Cysteine-Cysteine (CC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
84774|NCT01675427|E1|Reported Event|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
84775|NCT01675167|B3|Baseline|Total|Total of all reporting groups
84776|NCT01675167|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84777|NCT01675167|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84778|NCT01675167|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84779|NCT01675167|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84780|NCT01675167|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
84781|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84782|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84783|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84784|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84785|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84786|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84787|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84788|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84789|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84790|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84791|NCT01675167|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
84792|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84793|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84794|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84795|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84796|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84797|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
84798|NCT01675167|E3|Reported Event|DB Placebo Film|Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
84799|NCT01675167|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
84800|NCT01675167|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
84801|NCT01675128|B4|Baseline|Total|Total of all reporting groups
84802|NCT01675128|B3|Baseline|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84803|NCT01675128|B2|Baseline|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84804|NCT01675128|B1|Baseline|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84805|NCT01675128|P3|Participant Flow|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84806|NCT01675128|P2|Participant Flow|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84807|NCT01675128|P1|Participant Flow|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84808|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84809|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84810|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84811|NCT01675128|O1|Outcome|Phase I Dose Level I & Phase I Dose Level II|"Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.~Phase I Dose Level II Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks."
84812|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84813|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84814|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84815|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84816|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84817|NCT01675128|O1|Outcome|Phase I Dose Level 2|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84850|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84818|NCT01675128|O3|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84819|NCT01675128|O2|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84820|NCT01675128|O1|Outcome|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84821|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84822|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84823|NCT01675128|O1|Outcome|All Phase I Participants|Irinotecan 160 (and 180) mg/m^2 every other week.
84824|NCT01675128|O1|Outcome|All Phase I Participants|ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84825|NCT01675128|E3|Reported Event|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
84826|NCT01675128|E2|Reported Event|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84827|NCT01675128|E1|Reported Event|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
84828|NCT01675011|B3|Baseline|Total|Total of all reporting groups
84829|NCT01675011|B2|Baseline|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
84830|NCT01675011|B1|Baseline|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
84831|NCT01675011|P2|Participant Flow|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
84832|NCT01675011|P1|Participant Flow|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
84833|NCT01675011|O2|Outcome|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
84834|NCT01675011|O1|Outcome|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
84835|NCT01675011|E2|Reported Event|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
84836|NCT01675011|E1|Reported Event|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
84837|NCT01674725|B3|Baseline|Total|Total of all reporting groups
84838|NCT01674725|B2|Baseline|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84839|NCT01674725|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84840|NCT01674725|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84841|NCT01674725|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84842|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84843|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84844|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84845|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84846|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84847|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84848|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84849|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
85829|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
84851|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84852|NCT01674725|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
84853|NCT01674725|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
84854|NCT01674712|B6|Baseline|Total|Total of all reporting groups
84855|NCT01674712|B5|Baseline|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84856|NCT01674712|B4|Baseline|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84857|NCT01674712|B3|Baseline|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84858|NCT01674712|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84859|NCT01674712|B1|Baseline|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84860|NCT01674712|P5|Participant Flow|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84861|NCT01674712|P4|Participant Flow|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84862|NCT01674712|P3|Participant Flow|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84863|NCT01674712|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84864|NCT01674712|P1|Participant Flow|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84865|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84866|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84867|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84868|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84869|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84870|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84871|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84872|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84873|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84874|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84875|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84876|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84877|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84878|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84879|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84880|NCT01674712|E5|Reported Event|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
84881|NCT01674712|E4|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
84882|NCT01674712|E3|Reported Event|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
84883|NCT01674712|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
84884|NCT01674712|E1|Reported Event|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
84885|NCT01674647|B3|Baseline|Total|Total of all reporting groups
84886|NCT01674647|B2|Baseline|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84922|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord
84923|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord
85830|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
84887|NCT01674647|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84888|NCT01674647|P2|Participant Flow|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84889|NCT01674647|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84890|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84891|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84892|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84893|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84924|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord
84925|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord
84926|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84894|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84895|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84896|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84897|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84898|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84899|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84900|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84927|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84928|NCT01674634|E1|Reported Event|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84929|NCT01674621|B6|Baseline|Total|Total of all reporting groups
85831|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
84901|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84902|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84903|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84904|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84905|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84906|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84907|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84930|NCT01674621|B5|Baseline|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84931|NCT01674621|B4|Baseline|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
85832|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
84908|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84909|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84910|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84911|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84912|NCT01674647|E2|Reported Event|Vitamin K Antagonist|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
84913|NCT01674647|E1|Reported Event|Rivaroxaban (Xarelto; BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
84914|NCT01674634|B1|Baseline|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84915|NCT01674634|P1|Participant Flow|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84916|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84917|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84918|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84919|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84920|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84921|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
84994|NCT01674010|E3|Reported Event|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84932|NCT01674621|B3|Baseline|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84933|NCT01674621|B2|Baseline|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84934|NCT01674621|B1|Baseline|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84935|NCT01674621|P5|Participant Flow|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84936|NCT01674621|P4|Participant Flow|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
84937|NCT01674621|P3|Participant Flow|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84938|NCT01674621|P2|Participant Flow|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84939|NCT01674621|P1|Participant Flow|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84940|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84941|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
84942|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84943|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84944|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84945|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84946|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
84947|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84948|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84949|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84950|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84951|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
84952|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84953|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84954|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84955|NCT01674621|E5|Reported Event|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
84956|NCT01674621|E4|Reported Event|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
84957|NCT01674621|E3|Reported Event|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
84958|NCT01674621|E2|Reported Event|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
84959|NCT01674621|E1|Reported Event|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
84960|NCT01674062|B3|Baseline|Total|Total of all reporting groups
84961|NCT01674062|B2|Baseline|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
84962|NCT01674062|B1|Baseline|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84963|NCT01674062|P2|Participant Flow|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
84964|NCT01674062|P1|Participant Flow|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84965|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84966|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84967|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84968|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84969|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84995|NCT01674010|E2|Reported Event|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84996|NCT01674010|E1|Reported Event|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84997|NCT01673984|B3|Baseline|Total|Total of all reporting groups
85023|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85176|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
84970|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84971|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84972|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
84973|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
84974|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84975|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84976|NCT01674062|E2|Reported Event|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
84977|NCT01674062|E1|Reported Event|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
84978|NCT01674010|B1|Baseline|All Study Participants|
84979|NCT01674010|P3|Participant Flow|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84980|NCT01674010|P2|Participant Flow|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84981|NCT01674010|P1|Participant Flow|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84982|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84983|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84984|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84985|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84986|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84987|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84988|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84989|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84990|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84991|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
84992|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
84993|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
84998|NCT01673984|B2|Baseline|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
84999|NCT01673984|B1|Baseline|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85000|NCT01673984|P2|Participant Flow|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85001|NCT01673984|P1|Participant Flow|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85002|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85003|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85004|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85005|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85006|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85007|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85008|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85009|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85010|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85011|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85012|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85013|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85014|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85015|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85016|NCT01673984|E2|Reported Event|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
85017|NCT01673984|E1|Reported Event|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
85018|NCT01673919|B1|Baseline|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85019|NCT01673919|P1|Participant Flow|Tocilizumab (8 mg/kg)|Eligible participants received tocilizumab (TCZ) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in France, whichever came first.
85020|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85021|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85022|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85024|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85025|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85026|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85027|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85028|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85029|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85030|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85031|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85032|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85033|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85034|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85035|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85036|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85037|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85038|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85039|NCT01673919|E1|Reported Event|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
85040|NCT01673867|B3|Baseline|Total|Total of all reporting groups
85041|NCT01673867|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85042|NCT01673867|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85043|NCT01673867|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85044|NCT01673867|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85045|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85046|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85047|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85048|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85049|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85050|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85051|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85052|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85053|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85054|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85110|NCT01673594|B1|Baseline|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
85055|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85056|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85057|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85058|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85059|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85060|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85061|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85062|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85063|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85064|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85065|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85066|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85067|NCT01673867|E2|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85068|NCT01673867|E1|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
85069|NCT01673854|B1|Baseline|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
85070|NCT01673854|P1|Participant Flow|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
85071|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
85072|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
85073|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
85074|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
85111|NCT01673594|P2|Participant Flow|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
85075|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
85076|NCT01673854|E1|Reported Event|Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
85077|NCT01673802|B3|Baseline|Total|Total of all reporting groups
85078|NCT01673802|B2|Baseline|CT Imaging - Double Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT: double dose (0.05mmol/kg)"
85079|NCT01673802|B1|Baseline|CT Imaging - Single Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT. Single dose (0.025mmol/kg)"
85080|NCT01673802|P2|Participant Flow|CT Imaging - Double Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT: double dose (0.05mmol/kg)"
85081|NCT01673802|P1|Participant Flow|CT Imaging - Single Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT. Single dose (0.025mmol/kg)"
85082|NCT01673802|O2|Outcome|CT Imaging - Double Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT: double dose (0.05mmol/kg)"
85083|NCT01673802|O1|Outcome|CT Imaging - Single Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT. Single dose (0.025mmol/kg)"
85084|NCT01673802|E2|Reported Event|CT Imaging - Double Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT: double dose (0.05mmol/kg)"
85085|NCT01673802|E1|Reported Event|CT Imaging - Single Dose|"Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.~CT scan: Gadoxetate (Eovist) enhanced dual energy CT. Single dose (0.025mmol/kg)"
85086|NCT01673698|B3|Baseline|Total|Total of all reporting groups
85087|NCT01673698|B2|Baseline|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
85088|NCT01673698|B1|Baseline|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
85089|NCT01673698|P2|Participant Flow|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
85090|NCT01673698|P1|Participant Flow|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
85091|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
85092|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
85093|NCT01673698|O2|Outcome|Control|Control group
85094|NCT01673698|O1|Outcome|Treatment|Treatment group
85095|NCT01673698|E2|Reported Event|Control Subjects|Subjects who were randomized to diet and exercise counseling only during weeks 0-24
85096|NCT01673698|E1|Reported Event|Treatment Subjects|Subjects who were randomized and received a balloon during weeks 0-24
85097|NCT01673620|B3|Baseline|Total|Total of all reporting groups
85098|NCT01673620|B2|Baseline|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
85099|NCT01673620|B1|Baseline|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
85100|NCT01673620|P2|Participant Flow|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
85101|NCT01673620|P1|Participant Flow|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
85102|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
85103|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
85104|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
85105|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
85106|NCT01673620|E2|Reported Event|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
85107|NCT01673620|E1|Reported Event|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
85108|NCT01673594|B3|Baseline|Total|Total of all reporting groups
85109|NCT01673594|B2|Baseline|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
85112|NCT01673594|P1|Participant Flow|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
85113|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
85114|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
85115|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
85116|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
85117|NCT01673594|E2|Reported Event|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
85118|NCT01673594|E1|Reported Event|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
85119|NCT01673568|B3|Baseline|Total|Total of all reporting groups
85120|NCT01673568|B2|Baseline|no Abdominal Binder|no abdominal binder was warn
85121|NCT01673568|B1|Baseline|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
85122|NCT01673568|P2|Participant Flow|no Abdominal Binder|no abdominal binder
85123|NCT01673568|P1|Participant Flow|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
85124|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
85125|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
85126|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
85127|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
85128|NCT01673568|E2|Reported Event|no Abdominal Binder|no abdominal binder
85129|NCT01673568|E1|Reported Event|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
85130|NCT01673490|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85131|NCT01673490|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85132|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85133|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85134|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85135|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85136|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85174|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85137|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85138|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85139|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85140|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85141|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85142|NCT01673490|E1|Reported Event|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
85143|NCT01673425|B1|Baseline|Live Attenuated Influenza Vaccine Study|This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
85144|NCT01673425|P1|Participant Flow|Experimental: Live Attenuated Influenza Vaccine|Single intervention study; all participants receive LAIV
85145|NCT01673425|O1|Outcome|Experimental: Live Attenuated Influenza Vaccine|Single Intervention Study
85146|NCT01673425|E1|Reported Event|Study Enrollment|Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.
85147|NCT01673282|B3|Baseline|Total Title|
85148|NCT01673282|B2|Baseline|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
85149|NCT01673282|B1|Baseline|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
85150|NCT01673282|P2|Participant Flow|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
85151|NCT01673282|P1|Participant Flow|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
85152|NCT01673282|O2|Outcome|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
85153|NCT01673282|O1|Outcome|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
85154|NCT01673282|E2|Reported Event|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
85155|NCT01673282|E1|Reported Event|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
85156|NCT01673256|B1|Baseline|SJM Confirm ICM Observational Group|SJM Confirm ICM
85157|NCT01673256|P1|Participant Flow|SJM Confirm ICM Observational Group|SJM Confirm ICM
85158|NCT01673256|O1|Outcome|SJM Confirm ICM Observational Group|SJM Confirm ICM
85159|NCT01673256|E1|Reported Event|SJM Confirm ICM Observational Group|SJM Confirm ICM
85160|NCT01673178|B6|Baseline|Total|Total of all reporting groups
85161|NCT01673178|B5|Baseline|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85162|NCT01673178|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85163|NCT01673178|B3|Baseline|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85164|NCT01673178|B2|Baseline|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85165|NCT01673178|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85166|NCT01673178|P5|Participant Flow|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85167|NCT01673178|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85168|NCT01673178|P3|Participant Flow|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85169|NCT01673178|P2|Participant Flow|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85170|NCT01673178|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85171|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85172|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85173|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85833|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
85177|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85178|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85179|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85180|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85181|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85182|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85183|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85184|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85185|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85186|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85187|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85188|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85189|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85190|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85191|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85192|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85193|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85194|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85195|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85196|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85197|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85198|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85199|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85200|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85201|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85202|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85203|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85204|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85205|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85206|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85207|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85208|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85209|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85210|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85211|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85212|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85213|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85214|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85215|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85216|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85217|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85218|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85219|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85220|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85221|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85222|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85223|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85224|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85225|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85226|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85227|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85228|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85229|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85230|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85231|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85232|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85233|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85234|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85235|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85236|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85237|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85238|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85239|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85240|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85241|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85242|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85243|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85244|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85245|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85246|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85247|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85248|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85249|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85250|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85251|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85252|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85253|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85254|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85255|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85256|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85257|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85258|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85259|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85260|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85261|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85262|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85263|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85264|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85265|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85266|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85267|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85268|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85269|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85270|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85271|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85272|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85273|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85274|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85275|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85276|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85277|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85834|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
85278|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85279|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85280|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85281|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85282|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85283|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85284|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85285|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85286|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85287|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85288|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85289|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85290|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85291|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85292|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85293|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85294|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85295|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85296|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85297|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85298|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85299|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85300|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85301|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85302|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85303|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85304|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85305|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85306|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85307|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85308|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85309|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85310|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85311|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85312|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85313|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85314|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85315|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85316|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85317|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85318|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85319|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85320|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85321|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85322|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85323|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85324|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85325|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85326|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85327|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85328|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85329|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85330|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85331|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85332|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85333|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85334|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85335|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85336|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85337|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85338|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85339|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85340|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85341|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85342|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85343|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85344|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85345|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85346|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85347|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85348|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85349|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85350|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85351|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85352|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85353|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85354|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85355|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85356|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85357|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85358|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85359|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85360|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85361|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85362|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85363|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85364|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85365|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85366|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85367|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85368|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85369|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85370|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85371|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85372|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85373|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85374|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85375|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85376|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85377|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85378|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85379|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85380|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85381|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85382|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85383|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85384|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85385|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85386|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85387|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85388|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85389|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85390|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85391|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85392|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85393|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85394|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85395|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85396|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85397|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85398|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85399|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85400|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85401|NCT01673178|E5|Reported Event|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85402|NCT01673178|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85403|NCT01673178|E3|Reported Event|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
85404|NCT01673178|E2|Reported Event|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
85405|NCT01673178|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
85406|NCT01673126|B3|Baseline|Total|Total of all reporting groups
85407|NCT01673126|B2|Baseline|Sham tDCS First|Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.
85408|NCT01673126|B1|Baseline|Anodal tDCS First|Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.
85409|NCT01673126|P2|Participant Flow|Sham tDCS|Sham tDCS during first, then 2 days of washout, then anodal tDCS.
85410|NCT01673126|P1|Participant Flow|Anodal tDCS|Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.
85411|NCT01673126|O2|Outcome|Sham tDCS First|"Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
85412|NCT01673126|O1|Outcome|Anodal tDCS First|"Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
85413|NCT01673126|E2|Reported Event|Sham tDCS|"Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.~sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation."
85414|NCT01673126|E1|Reported Event|Anodal tDCS|"Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)~Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)"
85415|NCT01673009|B1|Baseline|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
85416|NCT01673009|P1|Participant Flow|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
85417|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
85457|NCT01672996|E2|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
85418|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
85419|NCT01673009|E1|Reported Event|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
85420|NCT01672996|B8|Baseline|Total|Total of all reporting groups
85421|NCT01672996|B7|Baseline|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85422|NCT01672996|B6|Baseline|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
85423|NCT01672996|B5|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
85424|NCT01672996|B4|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85425|NCT01672996|B3|Baseline|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
85426|NCT01672996|B2|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
85427|NCT01672996|B1|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
85428|NCT01672996|P3|Participant Flow|Arm 3 - Iopamidol 300mgI/mL|"Given as a single administration to the subject~Iopamidol 300 mgI/mL: Given as a single administration to the subject"
85429|NCT01672996|P2|Participant Flow|Arm 2 - Ioforminol 200mgI/mL|"Given as a single administration to the subject~Ioforminol 200 mgI/mL: Given as a single administration to the subject"
85430|NCT01672996|P1|Participant Flow|Arm 1 - Ioforminol 160mgI/mL|"Single administration of Ioforminol 160mgI/mL given to the subject.~Ioforminol 160 mgI/mL: Given as s single administration to the subject"
85431|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85432|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
85433|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
85434|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85435|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
85436|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
85437|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
85438|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85439|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
85440|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
85441|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85442|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
85443|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
85444|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
85445|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85446|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
85447|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
85448|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85449|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
85450|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
85451|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
85452|NCT01672996|E7|Reported Event|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85453|NCT01672996|E6|Reported Event|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
85454|NCT01672996|E5|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
85455|NCT01672996|E4|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
85456|NCT01672996|E3|Reported Event|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
85458|NCT01672996|E1|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
85459|NCT01672983|B7|Baseline|Total|Total of all reporting groups
85460|NCT01672983|B6|Baseline|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85461|NCT01672983|B5|Baseline|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85462|NCT01672983|B4|Baseline|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85463|NCT01672983|B3|Baseline|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85464|NCT01672983|B2|Baseline|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85465|NCT01672983|B1|Baseline|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85466|NCT01672983|P6|Participant Flow|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85467|NCT01672983|P5|Participant Flow|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85468|NCT01672983|P4|Participant Flow|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85469|NCT01672983|P3|Participant Flow|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85470|NCT01672983|P2|Participant Flow|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85471|NCT01672983|P1|Participant Flow|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85472|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85473|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85474|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85475|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85476|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85477|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85478|NCT01672983|O6|Outcome|Arm 6|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
85479|NCT01672983|O5|Outcome|Arm 5|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
85480|NCT01672983|O4|Outcome|Arm 4|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
85481|NCT01672983|O3|Outcome|Arm 3|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
85482|NCT01672983|O2|Outcome|Arm 2|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
85483|NCT01672983|O1|Outcome|Arm 1|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
85484|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85485|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85486|NCT01672983|O2|Outcome|Arm 2 + Arm 6|Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85487|NCT01672983|O1|Outcome|Arm 1 + Arm 5|Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85488|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85489|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85490|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85491|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85492|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85493|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85494|NCT01672983|E6|Reported Event|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85495|NCT01672983|E5|Reported Event|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85496|NCT01672983|E4|Reported Event|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85497|NCT01672983|E3|Reported Event|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
85498|NCT01672983|E2|Reported Event|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85499|NCT01672983|E1|Reported Event|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
85835|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
85836|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
85500|NCT01672970|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85501|NCT01672970|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85502|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85503|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85504|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85505|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85506|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85507|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85508|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85509|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85510|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85511|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85512|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85513|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85514|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85515|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85516|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85517|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85518|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85519|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85520|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85521|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85522|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85523|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85524|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85525|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85526|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85527|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85528|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85529|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85530|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85531|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85532|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85533|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85534|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85535|NCT01672970|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
85536|NCT01672957|B1|Baseline|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85537|NCT01672957|P1|Participant Flow|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
85538|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85539|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85540|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85629|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85837|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
85541|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85542|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85543|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85544|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85545|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85546|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85547|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85548|NCT01672957|E1|Reported Event|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
85549|NCT01672827|B1|Baseline|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
85550|NCT01672827|P1|Participant Flow|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
85551|NCT01672827|O1|Outcome|Specificity %|Specificity of the blinded visual PET Image Interpretations without Anatomic Images.
85552|NCT01672827|O1|Outcome|Inter-Reader Agreement|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.
85553|NCT01672827|O1|Outcome|Sensitivity %|Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
85554|NCT01672827|E1|Reported Event|[18F]Flutemetamol|No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
85555|NCT01672788|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study. This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
85556|NCT01672788|P4|Participant Flow|R2 / T2 / R1 / T1|"Patients received the 4 treatments in the following order:~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)"
85557|NCT01672788|P3|Participant Flow|T2 / R2 / T1 / R1|"Patients received the 4 treatments in the following order:~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)"
85838|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
85558|NCT01672788|P2|Participant Flow|R1 / T1 / R2 / T2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)"
85559|NCT01672788|P1|Participant Flow|T1 / R1 / T2 / R2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)"
85560|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85561|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85562|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85563|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85564|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85565|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85566|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85567|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85568|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85569|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85570|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85571|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85572|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85573|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85574|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85575|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85576|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85577|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85578|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85579|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85580|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85581|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85582|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85583|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85584|NCT01672788|E4|Reported Event|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
85585|NCT01672788|E3|Reported Event|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
85586|NCT01672788|E2|Reported Event|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
85587|NCT01672788|E1|Reported Event|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
85588|NCT01672723|B1|Baseline|Naltrexone First and Placebo First|Includes groups randomized to receive naltrexone first and placebo first.
85589|NCT01672723|P2|Participant Flow|Placebo First, Then Naltrexone|Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
85590|NCT01672723|P1|Participant Flow|Naltrexone First, Then Placebo|Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.
85591|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
85592|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
85593|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
85594|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
85595|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
85596|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
85597|NCT01672723|E2|Reported Event|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
85598|NCT01672723|E1|Reported Event|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
85599|NCT01672658|B3|Baseline|Total|Total of all reporting groups
85600|NCT01672658|B2|Baseline|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85601|NCT01672658|B1|Baseline|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85602|NCT01672658|P2|Participant Flow|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85603|NCT01672658|P1|Participant Flow|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85604|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85605|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85606|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85607|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85630|NCT01671839|E1|Reported Event|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85608|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85609|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85610|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85611|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85612|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85613|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85614|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85615|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85616|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85617|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85618|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85619|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85620|NCT01672658|E2|Reported Event|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
85621|NCT01672658|E1|Reported Event|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
85622|NCT01671839|B1|Baseline|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85623|NCT01671839|P1|Participant Flow|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85624|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85625|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85626|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85627|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85628|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
85631|NCT01671748|B3|Baseline|Total|Total of all reporting groups
85839|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
85632|NCT01671748|B2|Baseline|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85633|NCT01671748|B1|Baseline|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85634|NCT01671748|P2|Participant Flow|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85635|NCT01671748|P1|Participant Flow|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85636|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85637|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85638|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85639|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85640|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85641|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85642|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85643|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85644|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85645|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85646|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85647|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85648|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85649|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85650|NCT01671748|E2|Reported Event|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
85651|NCT01671748|E1|Reported Event|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
85652|NCT01671293|B3|Baseline|Total|Total of all reporting groups
85653|NCT01671293|B2|Baseline|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
85654|NCT01671293|B1|Baseline|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
85821|NCT01669863|E1|Reported Event|Use of ECMO in Non-intubated Patients|Patients on ECMO
85655|NCT01671293|P2|Participant Flow|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
85656|NCT01671293|P1|Participant Flow|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
85657|NCT01671293|O2|Outcome|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
85658|NCT01671293|O1|Outcome|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
85659|NCT01671293|E2|Reported Event|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
85660|NCT01671293|E1|Reported Event|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
85661|NCT01671111|B1|Baseline|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85662|NCT01671111|P1|Participant Flow|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 milligram per kilogram per day (mg/kg/day) (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85663|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85664|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85665|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85666|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85667|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85668|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85669|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85822|NCT01669811|B3|Baseline|Total|Total of all reporting groups
85840|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
85670|NCT01671111|E1|Reported Event|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
85671|NCT01671059|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85672|NCT01671059|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85673|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85674|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85675|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85676|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85677|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85678|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85679|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85680|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85681|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85682|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85683|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85684|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85685|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85686|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85687|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85688|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85689|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85690|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85691|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85692|NCT01671059|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85693|NCT01671059|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
85694|NCT01670721|B1|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85695|NCT01670721|P1|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85696|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85697|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85698|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85823|NCT01669811|B2|Baseline|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
85699|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
85700|NCT01670721|E1|Reported Event|Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
85701|NCT01670487|B3|Baseline|Total|Total of all reporting groups
85702|NCT01670487|B2|Baseline|Nature's Tears|Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
85703|NCT01670487|B1|Baseline|Vapocoolant (Pain Ease Medium Stream)|Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
85704|NCT01670487|P2|Participant Flow|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
85705|NCT01670487|P1|Participant Flow|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
85706|NCT01670487|O2|Outcome|Placebo (Nature's Tears)|Application of the stream steadily for 4 to 10 seconds
85707|NCT01670487|O1|Outcome|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
85708|NCT01670487|E2|Reported Event|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
85709|NCT01670487|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
85710|NCT01670279|B4|Baseline|Total|Total of all reporting groups
85711|NCT01670279|B3|Baseline|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85712|NCT01670279|B2|Baseline|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85713|NCT01670279|B1|Baseline|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85714|NCT01670279|P4|Participant Flow|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85715|NCT01670279|P3|Participant Flow|Brexpiprazole-Cohort 3|In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
85716|NCT01670279|P2|Participant Flow|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85717|NCT01670279|P1|Participant Flow|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85718|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85719|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85720|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85721|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85722|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85723|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85724|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85725|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85726|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85727|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85728|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85729|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85730|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85731|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85732|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85733|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85734|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85735|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85736|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85737|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85738|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85739|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85740|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85741|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85742|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85743|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85744|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85745|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85746|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85747|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85748|NCT01670279|E3|Reported Event|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
85749|NCT01670279|E2|Reported Event|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
85750|NCT01670279|E1|Reported Event|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
85751|NCT01670201|B1|Baseline|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
85752|NCT01670201|P1|Participant Flow|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
85753|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
85754|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
85755|NCT01670201|E1|Reported Event|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
85756|NCT01670045|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85757|NCT01670045|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85758|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85759|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85760|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85761|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85762|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85763|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85764|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85765|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85766|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85824|NCT01669811|B1|Baseline|D961H 20 mg BID|D961H 20 mg twice Daily
85825|NCT01669811|P2|Participant Flow|D961H 20 mg QD + Placebo|Hard capsule unidentifiable to D961H capsule 20 mg
85767|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85768|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85769|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85770|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85771|NCT01670045|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
85772|NCT01670019|B3|Baseline|Total|Total of all reporting groups
85773|NCT01670019|B2|Baseline|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85774|NCT01670019|B1|Baseline|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85775|NCT01670019|P2|Participant Flow|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85776|NCT01670019|P1|Participant Flow|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85777|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85778|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85779|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85780|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85781|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85782|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85783|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85784|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85785|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85786|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85826|NCT01669811|P1|Participant Flow|D961H 20 mg BID|Hard capsule containing 22.3 mg of D961H as enteric coated pellets
85787|NCT01670019|E2|Reported Event|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
85788|NCT01670019|E1|Reported Event|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
85789|NCT01669902|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85790|NCT01669902|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85791|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85792|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85793|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85794|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85795|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85796|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85797|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85798|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85799|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85800|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85801|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85802|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85803|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85804|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85805|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85806|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85807|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85808|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85809|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85810|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85811|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85812|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85813|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85814|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85815|NCT01669902|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
85816|NCT01669863|B1|Baseline|Use of ECMO in Non-intubated Patients|ECMO group
85817|NCT01669863|P1|Participant Flow|Use of ECMO in Non-intubated Patients|"ECMO used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
85818|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
85819|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
85820|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|"ECMO will be used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
85841|NCT01669811|E2|Reported Event|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
85842|NCT01669811|E1|Reported Event|D961H 20 mg BID|D961H 20 mg twice Daily
85843|NCT01669785|B4|Baseline|Total|Total of all reporting groups
85844|NCT01669785|B3|Baseline|Group C|NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.
85845|NCT01669785|B2|Baseline|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85846|NCT01669785|B1|Baseline|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85847|NCT01669785|P3|Participant Flow|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85848|NCT01669785|P2|Participant Flow|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85849|NCT01669785|P1|Participant Flow|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85850|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85851|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85852|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85853|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85854|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85855|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85856|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85857|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85858|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85859|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85860|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85861|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85862|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85863|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85864|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85865|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85866|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85867|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85868|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85869|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85870|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85871|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85872|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85873|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85874|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85875|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85876|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85877|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85878|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85879|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85880|NCT01669785|E3|Reported Event|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
85881|NCT01669785|E2|Reported Event|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
85882|NCT01669785|E1|Reported Event|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
85883|NCT01669720|B3|Baseline|Total|Total of all reporting groups
85884|NCT01669720|B2|Baseline|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
85885|NCT01669720|B1|Baseline|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
85886|NCT01669720|P2|Participant Flow|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
85887|NCT01669720|P1|Participant Flow|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
85888|NCT01669720|O2|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
85889|NCT01669720|O1|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
85890|NCT01669720|E2|Reported Event|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
85891|NCT01669720|E1|Reported Event|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
85892|NCT01669629|B1|Baseline|All Subjects|All subjects who were enrolled in the study.
85893|NCT01669629|P2|Participant Flow|Etafilcon A \ Delefilcon A|"6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
85894|NCT01669629|P1|Participant Flow|Delefilcon A \ Etafilcon A|"6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
85895|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
85896|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85897|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
85898|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85899|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
85900|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85901|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
85902|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85903|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
85904|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85905|NCT01669629|E2|Reported Event|Etafilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85906|NCT01669629|E1|Reported Event|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
85907|NCT01669577|B1|Baseline|Severe Trauma Patients|Hypotensive Patients (SBP<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS >15 to be included and a written informed consent should be available
85908|NCT01669577|P1|Participant Flow|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded"
85909|NCT01669577|O1|Outcome|Severe Trauma Patients|"intervention : analysis of blood samples; vital signs and clinical outcomes recorded~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
85910|NCT01669577|E1|Reported Event|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
85911|NCT01669174|B3|Baseline|Total|Total of all reporting groups
85912|NCT01669174|B2|Baseline|Placebo|Placebo to BYM338 30mg/kg
85913|NCT01669174|B1|Baseline|BYM338|30 mg/kg
85914|NCT01669174|P2|Participant Flow|Placebo|Placebo to BYM338 30mg/kg
85915|NCT01669174|P1|Participant Flow|BYM338|30 mg/kg
85916|NCT01669174|O1|Outcome|BYM338|30 mg/kg
85917|NCT01669174|O1|Outcome|BYM338|30 mg/kg
85918|NCT01669174|O1|Outcome|BYM338|30 mg/kg
85919|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
85920|NCT01669174|O1|Outcome|BYM338|30 mg/kg
85921|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
85922|NCT01669174|O1|Outcome|BYM338|30 mg/kg
85923|NCT01669174|E2|Reported Event|Placebo|Placebo to BYM338 30mg/kg
85924|NCT01669174|E1|Reported Event|BYM338 30mg/kg|BYM338 30mg/kg
85925|NCT01669122|B1|Baseline|Safety Population|Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
85926|NCT01669122|P1|Participant Flow|Total Participants|
85927|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85928|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85929|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85930|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85931|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85932|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85933|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85934|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85935|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85936|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85937|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85938|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85939|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85940|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85941|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85942|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85943|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85944|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85945|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85946|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A was administered orally as a single dose treatment.
85947|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85948|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85949|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85950|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85951|NCT01669122|E4|Reported Event|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
85952|NCT01669122|E3|Reported Event|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
85953|NCT01669122|E2|Reported Event|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
85954|NCT01669122|E1|Reported Event|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
85955|NCT01668836|B5|Baseline|Total|Total of all reporting groups
85956|NCT01668836|B4|Baseline|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85957|NCT01668836|B3|Baseline|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85958|NCT01668836|B2|Baseline|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85959|NCT01668836|B1|Baseline|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85960|NCT01668836|P4|Participant Flow|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
85961|NCT01668836|P3|Participant Flow|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
85962|NCT01668836|P2|Participant Flow|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85963|NCT01668836|P1|Participant Flow|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85964|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85965|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85966|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85967|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85968|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85969|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85970|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85971|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85972|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85973|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85974|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85975|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85976|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85977|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85978|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85979|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85980|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85981|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85982|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85983|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85984|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85985|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85986|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85987|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85988|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85989|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85990|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85991|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85992|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85993|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
85994|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85995|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
85996|NCT01668836|O4|Outcome|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
85997|NCT01668836|O3|Outcome|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
85998|NCT01668836|O2|Outcome|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
85999|NCT01668836|O1|Outcome|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
86000|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86001|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86002|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86003|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86004|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86005|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86006|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86007|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86008|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86009|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
86010|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86011|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
86012|NCT01668836|E4|Reported Event|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
86013|NCT01668836|E3|Reported Event|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
86014|NCT01668836|E2|Reported Event|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
86015|NCT01668836|E1|Reported Event|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
86016|NCT01668797|B3|Baseline|Total|Total of all reporting groups
86017|NCT01668797|B2|Baseline|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
86018|NCT01668797|B1|Baseline|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86019|NCT01668797|P4|Participant Flow|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
86020|NCT01668797|P3|Participant Flow|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86021|NCT01668797|P2|Participant Flow|Phase B (Stabilization Phase)|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
86022|NCT01668797|P1|Participant Flow|Phase A (Conversion Phase)|The purpose of the open-label conversion phase was 2-fold: 1) to cross-titrate the participants current antipsychotic treatment to brexpiprazole monotherapy over a period of 1 to 4 weeks and 2) to allow washout of prohibited medications in preparation for the stabilization phase.
86023|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86024|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86025|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86026|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86027|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86028|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86029|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86030|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86031|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86032|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86033|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86034|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86035|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86036|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86037|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86038|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86039|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86040|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86041|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86042|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86043|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86044|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86045|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86046|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86047|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86048|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86049|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86050|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86051|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86052|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86053|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86054|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86055|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86056|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86057|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86058|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86059|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86060|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86061|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86062|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86063|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86064|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86065|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86066|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86067|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86068|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86069|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86070|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86071|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86072|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86073|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86074|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86075|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86076|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86077|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86078|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86079|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
86080|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86081|NCT01668797|E3|Reported Event|Placebo (Double-blnd Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
86082|NCT01668797|E2|Reported Event|Brexpiprazole (Double-blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
86083|NCT01668797|E1|Reported Event|Single Blind Stabilization Phase|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
86084|NCT01668784|B3|Baseline|Total|Total of all reporting groups
86085|NCT01668784|B2|Baseline|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86086|NCT01668784|B1|Baseline|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86087|NCT01668784|P2|Participant Flow|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86088|NCT01668784|P1|Participant Flow|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86089|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86090|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86091|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86092|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86093|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86094|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86095|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86096|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86097|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86098|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86099|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86100|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86101|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86102|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86103|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86104|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86105|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86106|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86107|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86108|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86109|NCT01668784|E2|Reported Event|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86110|NCT01668784|E1|Reported Event|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
86111|NCT01668667|B5|Baseline|Total|Total of all reporting groups
86112|NCT01668667|B4|Baseline|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86113|NCT01668667|B3|Baseline|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86114|NCT01668667|B2|Baseline|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86115|NCT01668667|B1|Baseline|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86116|NCT01668667|P4|Participant Flow|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86117|NCT01668667|P3|Participant Flow|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86118|NCT01668667|P2|Participant Flow|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86119|NCT01668667|P1|Participant Flow|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86120|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86121|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86122|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86123|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86124|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86125|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86126|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86127|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86128|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86129|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86130|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86131|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86132|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
86133|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86134|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86135|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86136|NCT01668667|E4|Reported Event|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PMmatching placebo.
86137|NCT01668667|E3|Reported Event|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
86138|NCT01668667|E2|Reported Event|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
86139|NCT01668667|E1|Reported Event|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
86140|NCT01668654|B1|Baseline|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86141|NCT01668654|P1|Participant Flow|Retigabine/Ezogabine TID|Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86142|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86143|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86203|NCT01668589|P3|Participant Flow|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86204|NCT01668589|P2|Participant Flow|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86144|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86145|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86146|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86147|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86148|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86149|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86150|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86151|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86152|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86153|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86154|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86205|NCT01668589|P1|Participant Flow|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86300|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86155|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86156|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86157|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86158|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86159|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86160|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86161|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86162|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86163|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86164|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86165|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86206|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86301|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86166|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86167|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86168|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86169|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86170|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86171|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86172|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86173|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86174|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86175|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86176|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86207|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86302|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86177|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86178|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86179|NCT01668654|E1|Reported Event|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
86180|NCT01668628|B4|Baseline|Total|Total of all reporting groups
86181|NCT01668628|B3|Baseline|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
86182|NCT01668628|B2|Baseline|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
86183|NCT01668628|B1|Baseline|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
86184|NCT01668628|P3|Participant Flow|Prevalent Hemodialysis (HD) Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
86185|NCT01668628|P2|Participant Flow|Prevalent Peritoneal Dialysis (PD) Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
86186|NCT01668628|P1|Participant Flow|Incident Peritoneal Dialysis(PD) Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
86187|NCT01668628|O2|Outcome|Overhydration Group|Hemodialysis patients with baseline OH value >+2L
86188|NCT01668628|O1|Outcome|Normohydration Group|Hemodialysis patients with baseline -2L<OH value <+2L
86189|NCT01668628|O2|Outcome|Overhydration Group|Peritoneal dialysis patients with baseline OH value >+2L
86190|NCT01668628|O1|Outcome|Normohydration Group|Peritoneal dialysis patients with baseline -2L<OH value <+2L
86191|NCT01668628|O3|Outcome|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
86192|NCT01668628|O2|Outcome|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
86193|NCT01668628|O1|Outcome|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
86194|NCT01668628|E3|Reported Event|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
86195|NCT01668628|E2|Reported Event|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
86196|NCT01668628|E1|Reported Event|Incident PD Patients|First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
86197|NCT01668589|B5|Baseline|Total|Total of all reporting groups
86198|NCT01668589|B4|Baseline|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86199|NCT01668589|B3|Baseline|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86200|NCT01668589|B2|Baseline|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86201|NCT01668589|B1|Baseline|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86202|NCT01668589|P4|Participant Flow|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86208|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86209|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86210|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86211|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86212|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86213|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86214|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86215|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86216|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86217|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86218|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86219|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86220|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86221|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86222|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86223|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86224|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86225|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86226|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86227|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86228|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86229|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86230|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86231|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86232|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86233|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86234|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86299|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86235|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86236|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86237|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
86238|NCT01668589|E4|Reported Event|Belgium|Prolia 60 mg SC Q6M
86239|NCT01668589|E3|Reported Event|Greece|Prolia 60 mg SC Q6M
86240|NCT01668589|E2|Reported Event|Austria|Prolia 60 mg SC Q6M
86241|NCT01668589|E1|Reported Event|Germany|Prolia 60 mg SC Q6M
86242|NCT01668173|B1|Baseline|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
86243|NCT01668173|P1|Participant Flow|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
86244|NCT01668173|O1|Outcome|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
86245|NCT01668173|E1|Reported Event|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
86246|NCT01668004|B1|Baseline|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
86247|NCT01668004|P1|Participant Flow|GLM 50 mg|Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
86248|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
86249|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
86250|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
86251|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
86252|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
86253|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
86254|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
86255|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
86256|NCT01668004|E1|Reported Event|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
86257|NCT01667978|B3|Baseline|Total|Total of all reporting groups
86258|NCT01667978|B2|Baseline|Control|"o PI therapy, control group~Norethindrone acetate"
86259|NCT01667978|B1|Baseline|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
86260|NCT01667978|P2|Participant Flow|Control|"no PI therapy, control group~Norethindrone acetate~17 controls (4 no ARV)"
86261|NCT01667978|P1|Participant Flow|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate~16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)"
86262|NCT01667978|O2|Outcome|Control|"o PI therapy, control group~Norethindrone acetate"
86263|NCT01667978|O1|Outcome|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
86264|NCT01667978|E2|Reported Event|Control|"o PI therapy, control group~Norethindrone acetate"
86265|NCT01667978|E1|Reported Event|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
86266|NCT01667900|B6|Baseline|Total|Total of all reporting groups
86267|NCT01667900|B5|Baseline|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86268|NCT01667900|B4|Baseline|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86269|NCT01667900|B3|Baseline|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86270|NCT01667900|B2|Baseline|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86271|NCT01667900|B1|Baseline|Part A-Healthy|Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
86272|NCT01667900|P20|Participant Flow|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86273|NCT01667900|P19|Participant Flow|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86274|NCT01667900|P18|Participant Flow|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86275|NCT01667900|P17|Participant Flow|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
86276|NCT01667900|P16|Participant Flow|First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
86277|NCT01667900|P15|Participant Flow|First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86278|NCT01667900|P14|Participant Flow|First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
86279|NCT01667900|P13|Participant Flow|First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
86280|NCT01667900|P12|Participant Flow|First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
86281|NCT01667900|P11|Participant Flow|First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86282|NCT01667900|P10|Participant Flow|First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86283|NCT01667900|P9|Participant Flow|First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
86284|NCT01667900|P8|Participant Flow|First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
86285|NCT01667900|P7|Participant Flow|First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
86286|NCT01667900|P6|Participant Flow|First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
86287|NCT01667900|P5|Participant Flow|First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
86288|NCT01667900|P4|Participant Flow|First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86289|NCT01667900|P3|Participant Flow|First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86290|NCT01667900|P2|Participant Flow|First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
86291|NCT01667900|P1|Participant Flow|First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
86292|NCT01667900|O4|Outcome|Placebo (Part B-T2DM|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86293|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86294|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86295|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86296|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86297|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86298|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86348|NCT01667731|B6|Baseline|Total|Total of all reporting groups
86303|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86304|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86305|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86306|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86307|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86308|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86309|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86310|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86311|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86312|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86313|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86314|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86315|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86316|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
86317|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86318|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86319|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
86320|NCT01667900|E8|Reported Event|1.5 mg Dulaglutide (Part B-T2DM)|"1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86321|NCT01667900|E7|Reported Event|0.75 mg Dulaglutide (Part B-T2DM)|"0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86322|NCT01667900|E6|Reported Event|0.5 mg Dulaglutide (Part B-T2DM)|"0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86323|NCT01667900|E5|Reported Event|Placebo (Part B-T2DM)|"Placebo administered to participants with T2DM once weekly SQ for 4 weeks~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86324|NCT01667900|E4|Reported Event|1.5 mg Dulaglutide (Part A-Healthy)|"1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86325|NCT01667900|E3|Reported Event|0.75 mg Dulaglutide (Part A-Healthy)|"0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86326|NCT01667900|E2|Reported Event|0.5 mg Dulaglutide (Part A-Healthy)|"0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86327|NCT01667900|E1|Reported Event|Placebo (Part A-Healthy)|"Placebo administered once SQ to healthy participants in 1 of 3 treatment periods~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
86328|NCT01667848|B3|Baseline|Total|Total of all reporting groups
86329|NCT01667848|B2|Baseline|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
86330|NCT01667848|B1|Baseline|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
86331|NCT01667848|P2|Participant Flow|Group B: Insufflation With Warm Gas|Insufflation with warm gas during laparoscopic cholecystectomy
86332|NCT01667848|P1|Participant Flow|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
86333|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
86334|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
86335|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
86336|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
86337|NCT01667848|E2|Reported Event|Group B|Insufflation with warm gas during laparoscopic cholecystectomy
86338|NCT01667848|E1|Reported Event|Group A|Insufflation with cold gas during laparoscopic cholecystectomy
86339|NCT01667796|B3|Baseline|Total|Total of all reporting groups
86340|NCT01667796|B2|Baseline|Healthy Controls|Female subjects without MS
86341|NCT01667796|B1|Baseline|MS Subjects|Female subjects with MS
86342|NCT01667796|P2|Participant Flow|Healthy Controls|Healthy control subjects
86343|NCT01667796|P1|Participant Flow|MS Subjects|MS patients
86344|NCT01667796|O2|Outcome|Healthy Controls|Female subjects without MS
86345|NCT01667796|O1|Outcome|MS Subjects|Female subjects with MS
86346|NCT01667796|E2|Reported Event|Healthy Controls|Healthy control subjects
86347|NCT01667796|E1|Reported Event|MS Subjects|MS patients
86349|NCT01667731|B5|Baseline|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86350|NCT01667731|B4|Baseline|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86351|NCT01667731|B3|Baseline|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86352|NCT01667731|B2|Baseline|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86353|NCT01667731|B1|Baseline|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86354|NCT01667731|P5|Participant Flow|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86355|NCT01667731|P4|Participant Flow|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86356|NCT01667731|P3|Participant Flow|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
86357|NCT01667731|P2|Participant Flow|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86358|NCT01667731|P1|Participant Flow|SOF+RBV 12 Wk GT 2 TN|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
86359|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86360|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86361|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86362|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86363|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86364|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86365|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86366|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86367|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86368|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86369|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86370|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86371|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86372|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86373|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86374|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86375|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86376|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86377|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86378|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86379|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86380|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86381|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86382|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86383|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86384|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86385|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86386|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86513|NCT01666951|E2|Reported Event|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86387|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86388|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86389|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86390|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86391|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86392|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86393|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86394|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86395|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86396|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86397|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86398|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86399|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86400|NCT01667731|O2|Outcome|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
86401|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
86402|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86403|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
86404|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
86405|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
86406|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
86407|NCT01667731|E3|Reported Event|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
86408|NCT01667731|E2|Reported Event|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
86409|NCT01667731|E1|Reported Event|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
86410|NCT01667536|B1|Baseline|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86411|NCT01667536|P1|Participant Flow|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86412|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
86413|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
86414|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
86415|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
86416|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86417|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
86418|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86419|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86420|NCT01667536|E1|Reported Event|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
86421|NCT01667471|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86422|NCT01667471|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
86884|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86423|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86424|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86425|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86426|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86427|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86428|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86429|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86430|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86431|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86432|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86433|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86434|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86435|NCT01667471|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86436|NCT01667471|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
86437|NCT01667432|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
86438|NCT01667432|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
86439|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
86440|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
86441|NCT01667432|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
86442|NCT01667224|B3|Baseline|Total|Total of all reporting groups
86443|NCT01667224|B2|Baseline|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86444|NCT01667224|B1|Baseline|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86445|NCT01667224|P2|Participant Flow|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86446|NCT01667224|P1|Participant Flow|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86447|NCT01667224|O2|Outcome|Placebo (450mg/Day) for 12 Week|Placebo: Amount and calorie of placebo are same with Actiponin
86448|NCT01667224|O1|Outcome|Actiponin(450mg/Day) for 12week|Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
86449|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86450|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86451|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86452|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86453|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86454|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86455|NCT01667224|E2|Reported Event|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
86514|NCT01666951|E1|Reported Event|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86515|NCT01666782|B3|Baseline|Total|Total of all reporting groups
86456|NCT01667224|E1|Reported Event|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
86457|NCT01667107|B3|Baseline|Total|Total of all reporting groups
86458|NCT01667107|B2|Baseline|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86459|NCT01667107|B1|Baseline|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86460|NCT01667107|P2|Participant Flow|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86461|NCT01667107|P1|Participant Flow|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86462|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86463|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86464|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86465|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86466|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86467|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86468|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86469|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86470|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86471|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86516|NCT01666782|B2|Baseline|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86472|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86473|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86474|NCT01667107|E2|Reported Event|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86475|NCT01667107|E1|Reported Event|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
86476|NCT01666951|B3|Baseline|Total|Total of all reporting groups
86477|NCT01666951|B2|Baseline|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86478|NCT01666951|B1|Baseline|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86479|NCT01666951|P2|Participant Flow|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86480|NCT01666951|P1|Participant Flow|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86481|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86482|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86483|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86484|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86485|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86486|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86487|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86488|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86489|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86490|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86491|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86492|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86493|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86494|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86495|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86496|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86497|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86498|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86499|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86500|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86501|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86502|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86503|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86504|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86505|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86506|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86507|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86508|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86509|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86510|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86511|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
86512|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
86517|NCT01666782|B1|Baseline|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86518|NCT01666782|P2|Participant Flow|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86519|NCT01666782|P1|Participant Flow|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86520|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86521|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86522|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86523|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86524|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86525|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86526|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86527|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86528|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86529|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86530|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86531|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86532|NCT01666782|E2|Reported Event|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
86533|NCT01666782|E1|Reported Event|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
86534|NCT01666197|B3|Baseline|Total|Total of all reporting groups
86535|NCT01666197|B2|Baseline|Placebo|placebo: placebo
86536|NCT01666197|B1|Baseline|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
86537|NCT01666197|P2|Participant Flow|Placebo|placebo: placebo
86538|NCT01666197|P1|Participant Flow|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
86539|NCT01666197|O2|Outcome|Placebo|placebo: placebo
86540|NCT01666197|O1|Outcome|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
86541|NCT01666197|E2|Reported Event|Placebo|placebo: placebo
86542|NCT01666197|E1|Reported Event|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
86543|NCT01666002|B3|Baseline|Total|Total of all reporting groups
86544|NCT01666002|B2|Baseline|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
86545|NCT01666002|B1|Baseline|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
86546|NCT01666002|P2|Participant Flow|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
86547|NCT01666002|P1|Participant Flow|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture."
86548|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
86549|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
86550|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
86551|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49)."
86552|NCT01666002|E2|Reported Event|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
86553|NCT01666002|E1|Reported Event|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~No patients reported complications or adverse events after 2 sessions."
86554|NCT01665911|B1|Baseline|All Participants|"1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design"
86555|NCT01665911|P1|Participant Flow|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
86556|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
86557|NCT01665911|O1|Outcome|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
86558|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
86559|NCT01665911|E1|Reported Event|Arm/Group All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design."
86560|NCT01665807|B4|Baseline|Total|Total of all reporting groups
86561|NCT01665807|B3|Baseline|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86562|NCT01665807|B2|Baseline|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86563|NCT01665807|B1|Baseline|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
86624|NCT01665170|O1|Outcome|Placebo|Placebo arm
86564|NCT01665807|P3|Participant Flow|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86565|NCT01665807|P2|Participant Flow|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86566|NCT01665807|P1|Participant Flow|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
86567|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86568|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86569|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
86570|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86571|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86572|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
86573|NCT01665807|E3|Reported Event|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86574|NCT01665807|E2|Reported Event|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
86575|NCT01665807|E1|Reported Event|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
86576|NCT01665170|B3|Baseline|Total|Total of all reporting groups
86577|NCT01665170|B2|Baseline|Verum|Verum arm - Pascoflair 425mg
86578|NCT01665170|B1|Baseline|Placebo|Placebo arm
86579|NCT01665170|P2|Participant Flow|Verum|Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
86580|NCT01665170|P1|Participant Flow|Placebo|Placebo arm, 3 x 1 tablet per every day for 3 days
86581|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86582|NCT01665170|O1|Outcome|Placebo|Placebo arm
86583|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86584|NCT01665170|O1|Outcome|Placebo|Placebo arm
86585|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86586|NCT01665170|O1|Outcome|Placebo|Placebo arm
86587|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86588|NCT01665170|O1|Outcome|Placebo|Placebo arm
86589|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86590|NCT01665170|O1|Outcome|Placebo|Placebo arm
86591|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86592|NCT01665170|O1|Outcome|Placebo|Placebo arm
86593|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86594|NCT01665170|O1|Outcome|Placebo|Placebo arm
86595|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86596|NCT01665170|O1|Outcome|Placebo|Placebo arm
86597|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86598|NCT01665170|O1|Outcome|Placebo|Placebo arm
86599|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86600|NCT01665170|O1|Outcome|Placebo|Placebo arm
86601|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86602|NCT01665170|O1|Outcome|Placebo|Placebo arm
86603|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86604|NCT01665170|O1|Outcome|Placebo|Placebo arm
86605|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86606|NCT01665170|O1|Outcome|Placebo|Placebo arm
86607|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86608|NCT01665170|O1|Outcome|Placebo|Placebo arm
86609|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86610|NCT01665170|O1|Outcome|Placebo|Placebo arm
86611|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86612|NCT01665170|O1|Outcome|Placebo|Placebo arm
86613|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86614|NCT01665170|O1|Outcome|Placebo|Placebo arm
86615|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86616|NCT01665170|O1|Outcome|Placebo|Placebo arm
86617|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86618|NCT01665170|O1|Outcome|Placebo|Placebo arm
86619|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86620|NCT01665170|O1|Outcome|Placebo|Placebo arm
86621|NCT01665170|O2|Outcome|Placebo|Placebo arm
86622|NCT01665170|O1|Outcome|Verum|Verum arm - Pascoflair 425mg
86623|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
86628|NCT01665157|B3|Baseline|Low-residue Diet (Enimaclin®) Package and 1.5L PEG|Low-residue diet package with normal amount of 1.5L PEG-ELS
86629|NCT01665157|B2|Baseline|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount of 2L PEG-ELS
86630|NCT01665157|B1|Baseline|Low-residue Diet Package (Enimaclin®) and 2L PEG|Low-residue diet package with normal amount of 2L PEG-ELS
86631|NCT01665157|P3|Participant Flow|Low-residue Diet Package and 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86632|NCT01665157|P2|Participant Flow|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86633|NCT01665157|P1|Participant Flow|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86634|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86635|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86636|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86637|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
86638|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with 2L PEG-ELS
86639|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86640|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5 L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86641|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86642|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86643|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86644|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86645|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86646|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86647|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86648|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86649|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
86650|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86651|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86652|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86653|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
86654|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86655|NCT01665157|E3|Reported Event|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
86656|NCT01665157|E2|Reported Event|Self-controlled Diet|Self-controlled diet with normal amount 2L PEG-ELS
86657|NCT01665157|E1|Reported Event|Low-residue Diet Package|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
86658|NCT01665053|B3|Baseline|Total|Total of all reporting groups
86659|NCT01665053|B2|Baseline|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86660|NCT01665053|B1|Baseline|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86661|NCT01665053|P2|Participant Flow|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86662|NCT01665053|P1|Participant Flow|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86663|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86664|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86665|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86666|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86710|NCT01664949|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86667|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86668|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86669|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86670|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86671|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86672|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86673|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86674|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86675|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86676|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86677|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86678|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86679|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86680|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86681|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86682|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86683|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86684|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86685|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86686|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86687|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86711|NCT01664949|P2|Participant Flow|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86688|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86689|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86690|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86691|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86692|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86693|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86694|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86695|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86696|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86697|NCT01665053|E2|Reported Event|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
86698|NCT01665053|E1|Reported Event|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
86699|NCT01664975|B3|Baseline|Total|Total of all reporting groups
86700|NCT01664975|B2|Baseline|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
86701|NCT01664975|B1|Baseline|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
86702|NCT01664975|P2|Participant Flow|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
86703|NCT01664975|P1|Participant Flow|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
86704|NCT01664975|O2|Outcome|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
86705|NCT01664975|O1|Outcome|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
86706|NCT01664975|E2|Reported Event|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
86707|NCT01664975|E1|Reported Event|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
86708|NCT01664949|B3|Baseline|Total|Total of all reporting groups
86709|NCT01664949|B2|Baseline|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
88071|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
86712|NCT01664949|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86713|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86714|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86715|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86716|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86717|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86718|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86719|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86720|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86721|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86722|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86723|NCT01664949|E2|Reported Event|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86724|NCT01664949|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
86725|NCT01664923|B3|Baseline|Total|Total of all reporting groups
86726|NCT01664923|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86727|NCT01664923|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86728|NCT01664923|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86729|NCT01664923|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86730|NCT01664923|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86731|NCT01664923|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86732|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86733|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86734|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86735|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86736|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86737|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86738|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86739|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86740|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86741|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86742|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86743|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86744|NCT01664923|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
86745|NCT01664923|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
86746|NCT01664806|B3|Baseline|Total|Total of all reporting groups
86747|NCT01664806|B2|Baseline|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
86778|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86748|NCT01664806|B1|Baseline|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
86749|NCT01664806|P2|Participant Flow|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
86750|NCT01664806|P1|Participant Flow|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
86751|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
86752|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
86753|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
86754|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
86755|NCT01664806|E2|Reported Event|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
86756|NCT01664806|E1|Reported Event|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
86757|NCT01664793|B3|Baseline|Total|Total of all reporting groups
86758|NCT01664793|B2|Baseline|Control Group|Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
86759|NCT01664793|B1|Baseline|Intervention Group|Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
86760|NCT01664793|P2|Participant Flow|Control Group|Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
86761|NCT01664793|P1|Participant Flow|Intervention Group|"Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.~Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination."
86762|NCT01664793|O2|Outcome|Control Group|This group did not rate effectiveness of the intervention.
86763|NCT01664793|O1|Outcome|Intervention Group|2 respondents in each of 10 diverse pediatric and family medicine practices.
86764|NCT01664793|O2|Outcome|Control Group|Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
86765|NCT01664793|O1|Outcome|Intervention Group|Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
86766|NCT01664793|E2|Reported Event|Control Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
86767|NCT01664793|E1|Reported Event|Intervention Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
86768|NCT01664624|B5|Baseline|Total|Total of all reporting groups
86769|NCT01664624|B4|Baseline|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86770|NCT01664624|B3|Baseline|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86771|NCT01664624|B2|Baseline|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86772|NCT01664624|B1|Baseline|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86773|NCT01664624|P4|Participant Flow|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86774|NCT01664624|P3|Participant Flow|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86775|NCT01664624|P2|Participant Flow|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86776|NCT01664624|P1|Participant Flow|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86777|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86779|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86780|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86781|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86782|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86783|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86784|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86785|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86786|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86787|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86788|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86789|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86790|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86791|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86792|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86793|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86794|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86795|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86796|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86797|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86798|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86799|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86800|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86801|NCT01664624|E4|Reported Event|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
86802|NCT01664624|E3|Reported Event|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
86803|NCT01664624|E2|Reported Event|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
86804|NCT01664624|E1|Reported Event|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
86805|NCT01664559|B3|Baseline|Total|Total of all reporting groups
86806|NCT01664559|B2|Baseline|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86807|NCT01664559|B1|Baseline|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86808|NCT01664559|P2|Participant Flow|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86809|NCT01664559|P1|Participant Flow|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86810|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86811|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86812|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86813|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86814|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86815|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86816|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86817|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
88302|NCT01658514|B3|Baseline|Moderate RI|Moderate Renal Impairment = eGFR ≥30 to <60 mL/min/1.73 m²
86818|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86819|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86820|NCT01664559|E2|Reported Event|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
86821|NCT01664559|E1|Reported Event|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
86822|NCT01664533|B1|Baseline|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86823|NCT01664533|P1|Participant Flow|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86824|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86825|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86826|NCT01664533|O1|Outcome|Erlotinib|"Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.~Erlotinib: Erlotinib was supplied as tablets in the retail product Tarceva."
86827|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86828|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86829|NCT01664533|E1|Reported Event|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
86830|NCT01664494|B1|Baseline|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
86831|NCT01664494|P1|Participant Flow|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
86832|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
86833|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
86834|NCT01664494|E1|Reported Event|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
86835|NCT01664247|B3|Baseline|Total|Total of all reporting groups
86836|NCT01664247|B2|Baseline|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86837|NCT01664247|B1|Baseline|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86838|NCT01664247|P2|Participant Flow|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86839|NCT01664247|P1|Participant Flow|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86840|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86841|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86842|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86843|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86844|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86845|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86846|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86847|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86848|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86849|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86850|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86851|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86852|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86853|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86854|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86855|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86856|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86857|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86858|NCT01664247|E2|Reported Event|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86859|NCT01664247|E1|Reported Event|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
86860|NCT01664117|B1|Baseline|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
86861|NCT01664117|P1|Participant Flow|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
86862|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86863|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86864|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
86865|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
86866|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
86867|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
86868|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
86869|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
86870|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
86871|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
86872|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86873|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86874|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86875|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86876|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86877|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86878|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86879|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86880|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86881|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86882|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86883|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86885|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86886|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86887|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86888|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86889|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86890|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86891|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86892|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86893|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86894|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86895|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86896|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86897|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86898|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
86899|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86900|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86901|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86902|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86903|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86904|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86905|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86906|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86907|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86908|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86909|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86910|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86911|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86912|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86913|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86914|NCT01664117|E1|Reported Event|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
86915|NCT01664052|B3|Baseline|Total|Total of all reporting groups
86916|NCT01664052|B2|Baseline|ESS305/ESS505|Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)
86917|NCT01664052|B1|Baseline|ESS505-A|Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).
86918|NCT01664052|P2|Participant Flow|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86919|NCT01664052|P1|Participant Flow|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86920|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86921|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
88303|NCT01658514|B2|Baseline|Mild RI|Mild Renal Impairment = eGFR ≥60 to <90 mL/min/1.73 m²
86922|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86923|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86924|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86925|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86926|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86927|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86928|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86929|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86930|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
86931|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86932|NCT01664052|E2|Reported Event|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
88304|NCT01658514|B1|Baseline|Normal|Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
86933|NCT01664052|E1|Reported Event|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
86934|NCT01664039|B3|Baseline|Total|Total of all reporting groups
86935|NCT01664039|B2|Baseline|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86936|NCT01664039|B1|Baseline|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86937|NCT01664039|P2|Participant Flow|LUMIGAN|One drop to the study eye(s) once a day in the evening, for 6 months
86938|NCT01664039|P1|Participant Flow|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86939|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86940|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86941|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86942|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86943|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86944|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86945|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86946|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86947|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86948|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86949|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86950|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86951|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86952|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86953|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86954|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86955|NCT01664039|E2|Reported Event|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
86956|NCT01664039|E1|Reported Event|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
86957|NCT01663987|B3|Baseline|Total|Total of all reporting groups
86958|NCT01663987|B2|Baseline|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86959|NCT01663987|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86960|NCT01663987|P2|Participant Flow|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86961|NCT01663987|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86962|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86963|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86964|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86965|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86966|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86967|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86968|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86969|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86970|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86971|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86972|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86973|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86974|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86975|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86976|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86977|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86978|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86979|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86980|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86981|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86982|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86983|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86984|NCT01663987|E2|Reported Event|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
86985|NCT01663987|E1|Reported Event|Placebo|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
86986|NCT01663922|B1|Baseline|All Participants|Descriptive analysis of combined groups
86987|NCT01663922|P2|Participant Flow|Group B (Boceprevir Then St John's Wort)|"Boceprevir for 5 days (10-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)~SJW from day 43 to day 56"
86988|NCT01663922|P1|Participant Flow|Group A (St John's Wort Then Boceprevir)|"St John’s Wort, (SJW) for 14 days (1-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)]~boceprevir from day 52 to day 56"
86989|NCT01663922|O1|Outcome|All Participants|Combined analysis of both group sequences
86990|NCT01663922|E2|Reported Event|Group B|Boceprevir first
86991|NCT01663922|E1|Reported Event|Group A|St John's Wort first
86992|NCT01663779|B3|Baseline|Total|Total of all reporting groups
86993|NCT01663779|B2|Baseline|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
86994|NCT01663779|B1|Baseline|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
86995|NCT01663779|P2|Participant Flow|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
86996|NCT01663779|P1|Participant Flow|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
86997|NCT01663779|O2|Outcome|Palpation|palpation artery
86998|NCT01663779|O1|Outcome|Ultrasound|ultrasound atery
86999|NCT01663779|E2|Reported Event|Palpation|palpation artery
87000|NCT01663779|E1|Reported Event|Ultrasound|ultrasound artery
87001|NCT01663727|B3|Baseline|Total|Total of all reporting groups
87002|NCT01663727|B2|Baseline|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87003|NCT01663727|B1|Baseline|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87004|NCT01663727|P2|Participant Flow|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 milligram per kilogram (mg/kg) on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87005|NCT01663727|P1|Participant Flow|Paclitaxel+Placebo|Participants received paclitaxel 90 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87006|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87007|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87008|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87009|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87010|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87011|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87012|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87013|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87014|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87015|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87016|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87017|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87018|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87019|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87020|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87021|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87022|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87023|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87024|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87025|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87026|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87027|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87028|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87029|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87030|NCT01663727|E2|Reported Event|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87031|NCT01663727|E1|Reported Event|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
87032|NCT01663714|B1|Baseline|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87033|NCT01663714|P1|Participant Flow|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87034|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87063|NCT01663532|P1|Participant Flow|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87734|NCT01660802|P1|Participant Flow|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87035|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87036|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87037|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87038|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87039|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87040|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87041|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87042|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87064|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87149|NCT01663103|P1|Participant Flow|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87043|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87044|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87045|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87046|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87047|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87048|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87049|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87050|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87083|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87272|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87051|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87052|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87053|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87054|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87055|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87056|NCT01663714|E3|Reported Event|Combined Regimen Period|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
87057|NCT01663714|E2|Reported Event|Period After Dosimetric and Therapeutic Dose|After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.
87058|NCT01663714|E1|Reported Event|Period After CVP|Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days
87059|NCT01663532|B3|Baseline|Total|Total of all reporting groups
87060|NCT01663532|B2|Baseline|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87061|NCT01663532|B1|Baseline|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87062|NCT01663532|P2|Participant Flow|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87735|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
87065|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87066|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87067|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87068|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87069|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87070|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87071|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87072|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87073|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87074|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87075|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87076|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87077|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87078|NCT01663532|E2|Reported Event|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
87079|NCT01663532|E1|Reported Event|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
87080|NCT01663506|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87081|NCT01663506|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87082|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87736|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87084|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87085|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87086|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87087|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87088|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87089|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87090|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87091|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87092|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87093|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87094|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87095|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87096|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87097|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87098|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87099|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87100|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87101|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87102|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87103|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87104|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87737|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
87105|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87106|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87107|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87108|NCT01663506|E1|Reported Event|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
87109|NCT01663363|B1|Baseline|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
87110|NCT01663363|P1|Participant Flow|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
87111|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
87112|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
87113|NCT01663363|E1|Reported Event|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
87114|NCT01663285|B1|Baseline|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87115|NCT01663285|P1|Participant Flow|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87116|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87117|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87118|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87119|NCT01663285|E1|Reported Event|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
87120|NCT01663233|B3|Baseline|Total|Total of all reporting groups
87121|NCT01663233|B2|Baseline|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87122|NCT01663233|B1|Baseline|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87123|NCT01663233|P2|Participant Flow|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87124|NCT01663233|P1|Participant Flow|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87125|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87126|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87738|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87127|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87128|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87129|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87130|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87131|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87132|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87133|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87134|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87135|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87136|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87137|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87138|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87139|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87140|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87141|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87142|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87143|NCT01663233|E2|Reported Event|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
87144|NCT01663233|E1|Reported Event|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
87145|NCT01663103|B3|Baseline|Total|Total of all reporting groups
87146|NCT01663103|B2|Baseline|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87147|NCT01663103|B1|Baseline|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87148|NCT01663103|P2|Participant Flow|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87271|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87150|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87151|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87152|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87153|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87154|NCT01663103|O4|Outcome|Placebo: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
87155|NCT01663103|O3|Outcome|Placebo: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
87156|NCT01663103|O2|Outcome|Rilonacept: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.
87157|NCT01663103|O1|Outcome|Rilonacept: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.
87158|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87159|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87160|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87161|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87162|NCT01663103|E2|Reported Event|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
87163|NCT01663103|E1|Reported Event|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
87164|NCT01663012|B1|Baseline|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87165|NCT01663012|P1|Participant Flow|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87166|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87167|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87168|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87169|NCT01663012|E1|Reported Event|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
87170|NCT01662999|B7|Baseline|Total|Total of all reporting groups
87171|NCT01662999|B6|Baseline|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
87172|NCT01662999|B5|Baseline|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
87173|NCT01662999|B4|Baseline|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
87174|NCT01662999|B3|Baseline|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
87175|NCT01662999|B2|Baseline|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
87176|NCT01662999|B1|Baseline|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
87177|NCT01662999|P6|Participant Flow|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet"
87178|NCT01662999|P5|Participant Flow|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
87179|NCT01662999|P4|Participant Flow|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral"
87180|NCT01662999|P3|Participant Flow|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
87181|NCT01662999|P2|Participant Flow|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
87182|NCT01662999|P1|Participant Flow|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
87183|NCT01662999|O6|Outcome|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
87739|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
87184|NCT01662999|O5|Outcome|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
87185|NCT01662999|O4|Outcome|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
87186|NCT01662999|O3|Outcome|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
87187|NCT01662999|O2|Outcome|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
87188|NCT01662999|O1|Outcome|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
87189|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87190|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
87191|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87192|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87193|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
87194|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87195|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87196|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
87197|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87198|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87199|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
87200|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87201|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87202|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
87203|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87204|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87205|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
87206|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87207|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
87208|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|A single oral tablet dose of 10 mg Dapagliflozin.
87209|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
87210|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin..
87211|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Treatment B: A single oral tablet dose of 10 mg Dapagliflozin.
87212|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Treatment A: Single dose oral tablet of 5 mg saxagliptin..
87213|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87214|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
87215|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87216|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
87217|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87218|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single saxagliptin 5mg, Tablet, Oral.
87219|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87220|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
87221|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87222|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
87223|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87224|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
87225|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87226|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
87227|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87228|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
87229|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87230|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
87231|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87232|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
87233|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87234|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
87235|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87236|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose Saxagliptin 5mg, Tablet, Oral.
87237|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87238|NCT01662999|O1|Outcome|10mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
87239|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87240|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
87241|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87242|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
87243|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87244|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
87245|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
87246|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
87247|NCT01662999|E3|Reported Event|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, Once daily, 1 day in each of 3 periods.
87248|NCT01662999|E2|Reported Event|Treatment B: Dapagliflozin 10mg|Dapagliflozin 10mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
87249|NCT01662999|E1|Reported Event|Treatment A: Saxagliptin 5mg|Saxagliptin 5mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
87250|NCT01662986|B3|Baseline|Total|Total of all reporting groups
87251|NCT01662986|B2|Baseline|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87252|NCT01662986|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87253|NCT01662986|P2|Participant Flow|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87254|NCT01662986|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87255|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87256|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87257|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87258|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87259|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87260|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87261|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87262|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87263|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87264|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87265|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87266|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87267|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87268|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87269|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87270|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87273|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87274|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87275|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87276|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87277|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87278|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87279|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
87280|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
87281|NCT01662986|E2|Reported Event|Tiotropium Bromide (18 μg)|Patient to receive one tiotropium bromide inhalation powder capsule once daily in the morning via HandiHaler
87282|NCT01662986|E1|Reported Event|Placebo|Patient to receive one placebo inhalation powder capsule once daily in the morning via HandiHaler
87283|NCT01662882|B4|Baseline|Total|Total of all reporting groups
87284|NCT01662882|B3|Baseline|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
87285|NCT01662882|B2|Baseline|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87286|NCT01662882|B1|Baseline|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87287|NCT01662882|P3|Participant Flow|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
87288|NCT01662882|P2|Participant Flow|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87289|NCT01662882|P1|Participant Flow|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87290|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87291|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
87292|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87293|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87294|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
87295|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87296|NCT01662882|E3|Reported Event|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87297|NCT01662882|E2|Reported Event|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
87298|NCT01662882|E1|Reported Event|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
87299|NCT01662791|B3|Baseline|Total|Total of all reporting groups
87300|NCT01662791|B2|Baseline|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87301|NCT01662791|B1|Baseline|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87302|NCT01662791|P2|Participant Flow|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study.
87303|NCT01662791|P1|Participant Flow|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87304|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87305|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87306|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87307|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87740|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87308|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87309|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87310|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87311|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87312|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87313|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87314|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87315|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87316|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87317|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87318|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87319|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87320|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87321|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87322|NCT01662791|E2|Reported Event|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
87323|NCT01662791|E1|Reported Event|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
87324|NCT01662765|B3|Baseline|Total|Total of all reporting groups
87325|NCT01662765|B2|Baseline|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
87741|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
87326|NCT01662765|B1|Baseline|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry."
87327|NCT01662765|P2|Participant Flow|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
87328|NCT01662765|P1|Participant Flow|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
87329|NCT01662765|O2|Outcome|Surgery|Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
87330|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
87331|NCT01662765|O2|Outcome|Surgery|Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
87332|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
87333|NCT01662765|O2|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
87334|NCT01662765|O1|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.~Surgery: modified umbilectomy"
87335|NCT01662765|O2|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
87336|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
87337|NCT01662765|E2|Reported Event|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture."
87338|NCT01662765|E1|Reported Event|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
87339|NCT01662648|B3|Baseline|Total|Total of all reporting groups
87340|NCT01662648|B2|Baseline|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87341|NCT01662648|B1|Baseline|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87342|NCT01662648|P2|Participant Flow|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87343|NCT01662648|P1|Participant Flow|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87344|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87345|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87346|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87347|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87348|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87349|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87350|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87351|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87352|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87353|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87354|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87355|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87356|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87357|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87358|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87359|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87360|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87361|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87362|NCT01662648|E2|Reported Event|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
87363|NCT01662648|E1|Reported Event|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
87364|NCT01662635|B1|Baseline|Demographics and Clinical Features of Overall Population|The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
87618|NCT01661790|O2|Outcome|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87365|NCT01662635|P1|Participant Flow|Determination of ALK by FISH, IHC and RT-qPCR|"The only inclusion criterion was the availability of tissue for biomarker studies.~We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)"
87366|NCT01662635|O3|Outcome|RT-qPCR Test|The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556_ft (E13;A20), Hs03654557_ft (E20;A20), Hs03654558_ft (E6;A20), Hs03654560_ft (E17;A20), and Hs03654559_ft (E18;A20). Hs02758991_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
87367|NCT01662635|O2|Outcome|IHC Test|using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
87368|NCT01662635|O1|Outcome|FISH Test|We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
87369|NCT01662635|E1|Reported Event|Adverse Events Not Collected|"Serious and Other were not collected/assessed in this observational study."
87370|NCT01662583|B4|Baseline|Total|Total of all reporting groups
87371|NCT01662583|B3|Baseline|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
87372|NCT01662583|B2|Baseline|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
87373|NCT01662583|B1|Baseline|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
87374|NCT01662583|P3|Participant Flow|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
87375|NCT01662583|P2|Participant Flow|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
87376|NCT01662583|P1|Participant Flow|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
87377|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
87378|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
87379|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
87380|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
87381|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
87382|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
87383|NCT01662583|E3|Reported Event|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
87384|NCT01662583|E2|Reported Event|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
87385|NCT01662583|E1|Reported Event|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
87386|NCT01662531|B3|Baseline|Total|Total of all reporting groups
87387|NCT01662531|B2|Baseline|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87388|NCT01662531|B1|Baseline|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87389|NCT01662531|P1|Participant Flow|rIX-FP|"Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.~rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)"
87390|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87391|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87392|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87393|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87394|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87395|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87396|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87397|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87398|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87399|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87400|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87401|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87402|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87403|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87404|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87405|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87406|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87407|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87408|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87409|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87410|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87411|NCT01662531|E1|Reported Event|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
87412|NCT01662440|B5|Baseline|Total|Total of all reporting groups
87413|NCT01662440|B4|Baseline|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87414|NCT01662440|B3|Baseline|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
87415|NCT01662440|B2|Baseline|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87416|NCT01662440|B1|Baseline|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87417|NCT01662440|P4|Participant Flow|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87418|NCT01662440|P3|Participant Flow|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
87419|NCT01662440|P2|Participant Flow|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87729|NCT01660815|E1|Reported Event|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
87420|NCT01662440|P1|Participant Flow|R/JE – Conv|Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87421|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87422|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
87423|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87424|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87425|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87426|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87427|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87428|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87429|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87430|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87431|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87432|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87433|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87434|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87435|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87436|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87437|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87438|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87439|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87440|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87441|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87442|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87443|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87444|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87445|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87446|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87730|NCT01660802|B3|Baseline|Total|Total of all reporting groups
87731|NCT01660802|B2|Baseline|Sham|Sham administered in the study eye on Day 1.
87447|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87448|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87449|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87450|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87451|NCT01662440|O2|Outcome|JE – Conv|Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87452|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87453|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87454|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87455|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87456|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87457|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87458|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87459|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87460|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87461|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
87462|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87463|NCT01662440|E4|Reported Event|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
87464|NCT01662440|E3|Reported Event|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
87465|NCT01662440|E2|Reported Event|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
87466|NCT01662440|E1|Reported Event|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
87467|NCT01662362|B1|Baseline|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
87468|NCT01662362|P1|Participant Flow|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
87469|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
87470|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
87471|NCT01662362|E1|Reported Event|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
87472|NCT01662310|B1|Baseline|Entire Study Population|All the participants who were enrolled.
87656|NCT01661270|E3|Reported Event|Mixed Administration (Placebo and Aflibercept)|Participants who were originally randomized to receive either Placebo or Aflibercept, actually received both the treatment (Placebo and Aflibercept).
87473|NCT01662310|P5|Participant Flow|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87474|NCT01662310|P4|Participant Flow|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87475|NCT01662310|P3|Participant Flow|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
87476|NCT01662310|P2|Participant Flow|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87477|NCT01662310|P1|Participant Flow|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87478|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87479|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87480|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87481|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87482|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87483|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87484|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87485|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87486|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87487|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87488|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87489|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87490|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87491|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87492|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87493|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87724|NCT01660906|E1|Reported Event|Dasatinib|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87494|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87495|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87496|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87497|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87498|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87499|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87500|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87501|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
87502|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87503|NCT01662310|E5|Reported Event|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87504|NCT01662310|E4|Reported Event|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
87505|NCT01662310|E3|Reported Event|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
87506|NCT01662310|E2|Reported Event|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
87507|NCT01662310|E1|Reported Event|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
87508|NCT01662102|B3|Baseline|Total|Total of all reporting groups
87509|NCT01662102|B2|Baseline|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m^2 of rituximab every 8 weeks for 24 months (12 infusions)"
87510|NCT01662102|B1|Baseline|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
87511|NCT01662102|P2|Participant Flow|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
87512|NCT01662102|P1|Participant Flow|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
87513|NCT01662102|O2|Outcome|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
87531|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87725|NCT01660815|B1|Baseline|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
87514|NCT01662102|O1|Outcome|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
87515|NCT01662102|E2|Reported Event|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
87516|NCT01662102|E1|Reported Event|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
87517|NCT01662063|B3|Baseline|Total|Total of all reporting groups
87518|NCT01662063|B2|Baseline|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87519|NCT01662063|B1|Baseline|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87520|NCT01662063|P3|Participant Flow|Not Treated|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.
87521|NCT01662063|P2|Participant Flow|SC TCZ Every Week (QW)|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87522|NCT01662063|P1|Participant Flow|Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)|Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
87523|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87524|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87525|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87526|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87527|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87528|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87529|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87530|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87616|NCT01661790|P2|Participant Flow|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87532|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87533|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87534|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87535|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87536|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87537|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87538|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87539|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87540|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87541|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87542|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87543|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87544|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87545|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
87546|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
87547|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
87548|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
87549|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87726|NCT01660815|P1|Participant Flow|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
87550|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87551|NCT01662063|O1|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87552|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87553|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87554|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87555|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87556|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87557|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87558|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87559|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87560|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87561|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87562|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87563|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87564|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87565|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87566|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87567|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87568|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87569|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87570|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87571|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87572|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87573|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87574|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87575|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87576|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87577|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87578|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87579|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87580|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87581|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87582|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87583|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87584|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87585|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87586|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87587|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87727|NCT01660815|O2|Outcome|70-kg Model|Radiation dose estimate using a 70-kg model.
87588|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87589|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87590|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87591|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87592|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87593|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87594|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87595|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87596|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87597|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87598|NCT01662063|E2|Reported Event|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
87599|NCT01662063|E1|Reported Event|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
87600|NCT01661933|B1|Baseline|Gluten Micro-challenge|Single arm, vertical. All twelve healthy adults enrolled subjects were successfully inoculated with hookworm and there was no serious adverse response. Individual hemoglobin levels were all normal and the group mean had significantly increased unexpectedly at completion of the study. Histology was not graded until after low-dose challenge but retrospectively confirmed enrollment Marsh scores of M0-8, M1-1, M2-2 and M3a-1. All participants were complying with a gluten-free diet, were symptomatically well and had a normal anti-tTG.
87601|NCT01661933|P1|Participant Flow|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
87602|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
87603|NCT01661933|O1|Outcome|Necator Americanus, Pre-gluten Challenge|Single arm, vertical. Ten of 12 participants enrolled based on symptomatic tolerance of gluten and satisfactory histology during and after micro-challenge. 2 were withdrawn pre-GC-1g, one who was symptomatically intolerant of gluten and one who had M3a after micro-challenge. Pre-GC1g scores.
87617|NCT01661790|P1|Participant Flow|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week"
87728|NCT01660815|O1|Outcome|50-kg Model|Radiation dose estimate using a 50-kg model.
87604|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
87605|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, assessments including histology were performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
87606|NCT01661933|E1|Reported Event|Gluten Micro-challenge|Single arm, longitudinal study of responses to escalating gluten doses in people with celiac disease after infection with Necator americanus, a human hookworm.
87607|NCT01661881|B1|Baseline|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
87608|NCT01661881|P1|Participant Flow|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
87609|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
87610|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
87611|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
87612|NCT01661881|E1|Reported Event|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.~Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
87613|NCT01661790|B3|Baseline|Total|Total of all reporting groups
87614|NCT01661790|B2|Baseline|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87615|NCT01661790|B1|Baseline|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87732|NCT01660802|B1|Baseline|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87619|NCT01661790|O1|Outcome|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87620|NCT01661790|E2|Reported Event|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87621|NCT01661790|E1|Reported Event|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
87622|NCT01661621|B3|Baseline|Total|Total of all reporting groups
87623|NCT01661621|B2|Baseline|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87624|NCT01661621|B1|Baseline|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87625|NCT01661621|P2|Participant Flow|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87626|NCT01661621|P1|Participant Flow|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87627|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87628|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87629|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87630|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87631|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87632|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87633|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87634|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87635|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87636|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87637|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87638|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87639|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87640|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87641|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87642|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87643|NCT01661621|E2|Reported Event|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
87644|NCT01661621|E1|Reported Event|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
87645|NCT01661270|B3|Baseline|Total|Total of all reporting groups
87646|NCT01661270|B2|Baseline|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87647|NCT01661270|B1|Baseline|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87648|NCT01661270|P2|Participant Flow|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87649|NCT01661270|P1|Participant Flow|Placebo|Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87650|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87651|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87652|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87653|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87654|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87655|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87657|NCT01661270|E2|Reported Event|Aflibercept Only|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87658|NCT01661270|E1|Reported Event|Placebo Only|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
87659|NCT01661179|B1|Baseline|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
87660|NCT01661179|P1|Participant Flow|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
87661|NCT01661179|O1|Outcome|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
87662|NCT01661179|E1|Reported Event|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
87663|NCT01661140|B1|Baseline|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label MTX for 24 weeks.
87664|NCT01661140|P3|Participant Flow|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87665|NCT01661140|P2|Participant Flow|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87666|NCT01661140|P1|Participant Flow|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label methotrexate (MTX) for 24 weeks, which was the initial phase of the study.
87667|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87668|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87669|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87670|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87671|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87672|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87673|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87674|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87675|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87676|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87677|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87678|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87679|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87680|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87681|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87682|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87683|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87684|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87685|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87686|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87687|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87688|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87689|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87690|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87691|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87692|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87693|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87694|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87695|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy..
87696|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87697|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87698|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87699|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87700|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87701|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87702|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
87703|NCT01661140|E3|Reported Event|Methotrexate (MTX) Maintenance Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
87704|NCT01661140|E2|Reported Event|Methotrexate (MTX) Tapering Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
87705|NCT01661140|E1|Reported Event|Initial Phase|"At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks, which is the initial phase of the study.~Adverse events in this reporting group are those occurring in the open-label phase only."
87706|NCT01661114|B1|Baseline|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
87707|NCT01661114|P1|Participant Flow|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
87708|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
87709|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
87710|NCT01661114|E1|Reported Event|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
87711|NCT01661062|B1|Baseline|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
87712|NCT01661062|P1|Participant Flow|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
87713|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
87714|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
87715|NCT01661062|E1|Reported Event|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
87716|NCT01660906|B1|Baseline|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87717|NCT01660906|P1|Participant Flow|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87718|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87719|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87720|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87721|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87722|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87723|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
87733|NCT01660802|P2|Participant Flow|Sham|Sham administered in the study eye on Day 1.
87742|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87743|NCT01660802|E2|Reported Event|Sham|Sham administered in the study eye on Day 1.
87744|NCT01660802|E1|Reported Event|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
87745|NCT01660763|B3|Baseline|Total|Total of all reporting groups
87746|NCT01660763|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
87747|NCT01660763|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
87748|NCT01660763|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
87749|NCT01660763|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
87750|NCT01660763|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
87751|NCT01660763|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
87752|NCT01660763|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
87753|NCT01660763|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
87754|NCT01660698|B3|Baseline|Total|Total of all reporting groups
87755|NCT01660698|B2|Baseline|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87756|NCT01660698|B1|Baseline|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87757|NCT01660698|P2|Participant Flow|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87758|NCT01660698|P1|Participant Flow|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87759|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87760|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87761|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87762|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87763|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87764|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87765|NCT01660698|E2|Reported Event|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
87766|NCT01660698|E1|Reported Event|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
87767|NCT01660672|B1|Baseline|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
87768|NCT01660672|P1|Participant Flow|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
87769|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
87770|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
87771|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
87772|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
87773|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
87774|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
87775|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
87776|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
87777|NCT01660672|E1|Reported Event|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children."
87778|NCT01659736|B3|Baseline|Total|Total of all reporting groups
87779|NCT01659736|B2|Baseline|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87780|NCT01659736|B1|Baseline|TMS Therapy|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87781|NCT01659736|P2|Participant Flow|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87782|NCT01659736|P1|Participant Flow|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87783|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87784|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87785|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87786|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87787|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87788|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87789|NCT01659736|O2|Outcome|TMS- Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87790|NCT01659736|O1|Outcome|TMS- Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87791|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87792|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87793|NCT01659736|E2|Reported Event|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87794|NCT01659736|E1|Reported Event|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
87795|NCT01659554|B1|Baseline|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87796|NCT01659554|P1|Participant Flow|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87797|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87798|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87799|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87800|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87801|NCT01659554|E1|Reported Event|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
87802|NCT01660334|B1|Baseline|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
88063|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
87803|NCT01660334|P1|Participant Flow|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
87804|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
87805|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
87806|NCT01660334|E1|Reported Event|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
87807|NCT01660321|B1|Baseline|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87808|NCT01660321|P1|Participant Flow|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87809|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87810|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87811|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87812|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87813|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87814|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87815|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87816|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87817|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87818|NCT01660321|E1|Reported Event|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
87819|NCT01660230|B13|Baseline|Total|Total of all reporting groups
87820|NCT01660230|B12|Baseline|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87821|NCT01660230|B11|Baseline|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87822|NCT01660230|B10|Baseline|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87823|NCT01660230|B9|Baseline|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87824|NCT01660230|B8|Baseline|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87825|NCT01660230|B7|Baseline|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87826|NCT01660230|B6|Baseline|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87827|NCT01660230|B5|Baseline|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87828|NCT01660230|B4|Baseline|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87829|NCT01660230|B3|Baseline|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87830|NCT01660230|B2|Baseline|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87831|NCT01660230|B1|Baseline|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87832|NCT01660230|P12|Participant Flow|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87833|NCT01660230|P11|Participant Flow|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87834|NCT01660230|P10|Participant Flow|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87835|NCT01660230|P9|Participant Flow|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87836|NCT01660230|P8|Participant Flow|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87837|NCT01660230|P7|Participant Flow|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87838|NCT01660230|P6|Participant Flow|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88064|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
87839|NCT01660230|P5|Participant Flow|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87840|NCT01660230|P4|Participant Flow|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87841|NCT01660230|P3|Participant Flow|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87842|NCT01660230|P2|Participant Flow|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87843|NCT01660230|P1|Participant Flow|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87844|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87845|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87846|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87847|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87848|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87849|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87850|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87851|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87852|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87853|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87854|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87855|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87856|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87857|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87858|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87859|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87860|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87861|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87862|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87863|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87864|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87865|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87866|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87867|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87868|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87869|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87870|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87871|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87872|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87873|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87874|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87875|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87876|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87877|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87878|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87879|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87880|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87881|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87882|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87883|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87884|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87885|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87886|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87887|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87888|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87889|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87890|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87891|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87892|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87893|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87894|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87895|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87896|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87897|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87898|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87899|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87900|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87901|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87902|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87903|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87904|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87905|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87906|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87907|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87908|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87909|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87910|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87911|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87912|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87913|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87914|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87915|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87916|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87917|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87918|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87919|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87920|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87921|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87922|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
88065|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
88066|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
87923|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87924|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87925|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87926|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87927|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87928|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87929|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87930|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87931|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87932|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87933|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87934|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87935|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87936|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87937|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87938|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87939|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87940|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87941|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87942|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87943|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87944|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87945|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87946|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87947|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87948|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87949|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87950|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88067|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
87951|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87952|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87953|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87954|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87955|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87956|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87957|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87958|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87959|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87960|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87961|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87962|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87963|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87964|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87965|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87966|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87967|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87968|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87969|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87970|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87971|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87972|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87973|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87974|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87975|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87976|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87977|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87978|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
88068|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88069|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
87979|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87980|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87981|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87982|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87983|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87984|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87985|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87986|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
87987|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87988|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87989|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87990|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
87991|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
87992|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87993|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87994|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87995|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87996|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87997|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87998|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
87999|NCT01660230|E12|Reported Event|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
88000|NCT01660230|E11|Reported Event|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
88001|NCT01660230|E10|Reported Event|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
88002|NCT01660230|E9|Reported Event|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
88003|NCT01660230|E8|Reported Event|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
88004|NCT01660230|E7|Reported Event|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88005|NCT01660230|E6|Reported Event|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88070|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88006|NCT01660230|E5|Reported Event|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88007|NCT01660230|E4|Reported Event|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88008|NCT01660230|E3|Reported Event|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88009|NCT01660230|E2|Reported Event|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88010|NCT01660230|E1|Reported Event|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
88011|NCT01660191|B4|Baseline|Total|Total of all reporting groups
88012|NCT01660191|B3|Baseline|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88013|NCT01660191|B2|Baseline|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88014|NCT01660191|B1|Baseline|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88015|NCT01660191|P3|Participant Flow|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88016|NCT01660191|P2|Participant Flow|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88017|NCT01660191|P1|Participant Flow|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88018|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88019|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88020|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88021|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88022|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88023|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88024|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88025|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88026|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88027|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88028|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88029|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88030|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88031|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88032|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88033|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88034|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88035|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88036|NCT01660191|E3|Reported Event|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
88037|NCT01660191|E2|Reported Event|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
88038|NCT01660191|E1|Reported Event|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
88039|NCT01660022|B7|Baseline|Total|Total of all reporting groups
88040|NCT01660022|B6|Baseline|Placebo|Cohorts 1, 2, 3, 4 and 5
88041|NCT01660022|B5|Baseline|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800 mg / PQP 1440 mg
88042|NCT01660022|B4|Baseline|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300 mg / PQP 1440 mg
88043|NCT01660022|B3|Baseline|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 1440 mg
88044|NCT01660022|B2|Baseline|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 480 mg
88045|NCT01660022|B1|Baseline|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 160 mg
88046|NCT01660022|P6|Participant Flow|Placebo|Cohorts 1, 2, 3, 4 and 5
88047|NCT01660022|P5|Participant Flow|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800mg+PQP 1440mg
88048|NCT01660022|P4|Participant Flow|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300mg+PQP 1440mg
88049|NCT01660022|P3|Participant Flow|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 1440mg
88050|NCT01660022|P2|Participant Flow|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 480mg
88051|NCT01660022|P1|Participant Flow|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg / PQP 160mg
88052|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88053|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88054|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88055|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88056|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88057|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88058|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88059|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88060|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88061|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88062|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88072|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88073|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
88074|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88075|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
88076|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88077|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
88078|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88079|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
88080|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88081|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
88082|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88083|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88084|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88085|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88086|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88087|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88088|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
88089|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88090|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
88091|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88092|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
88093|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88094|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
88095|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88096|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
88097|NCT01660022|E9|Reported Event|Placebo|Cohorts 1, 2, 3, 4 and 5
88098|NCT01660022|E8|Reported Event|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
88099|NCT01660022|E7|Reported Event|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
88100|NCT01660022|E6|Reported Event|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
88101|NCT01660022|E5|Reported Event|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
88102|NCT01660022|E4|Reported Event|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
88103|NCT01660022|E3|Reported Event|OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
88104|NCT01660022|E2|Reported Event|OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
88105|NCT01660022|E1|Reported Event|OZ439 100mg|Cohorts 1, 2 and 3 OZ439 100mg
88106|NCT01659996|B4|Baseline|Total|Total of all reporting groups
88107|NCT01659996|B3|Baseline|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
88108|NCT01659996|B2|Baseline|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
88109|NCT01659996|B1|Baseline|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88110|NCT01659996|P3|Participant Flow|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
88111|NCT01659996|P2|Participant Flow|Menactra + Pentacel Vaccine Group|All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88112|NCT01659996|P1|Participant Flow|Menactra Vaccine Group|All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88113|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88114|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88115|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88116|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
88117|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88118|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
88119|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88120|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88121|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88122|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88123|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88124|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88125|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
88126|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88127|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
88128|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
88129|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88130|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
88131|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88132|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88133|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88134|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88135|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88136|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88137|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
88138|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
88139|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
88140|NCT01659996|E3|Reported Event|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
88141|NCT01659996|E2|Reported Event|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
88142|NCT01659996|E1|Reported Event|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
88143|NCT01659853|B1|Baseline|Overall Study|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
88144|NCT01659853|P2|Participant Flow|Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
88145|NCT01659853|P1|Participant Flow|CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
88146|NCT01659853|O2|Outcome|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
88147|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
88148|NCT01659853|O2|Outcome|Azelaic Acid Gel 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
88149|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5% and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
88168|NCT01659125|P1|Participant Flow|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
88169|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
88150|NCT01659853|E2|Reported Event|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
88151|NCT01659853|E1|Reported Event|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
88152|NCT01659268|B3|Baseline|Total|Total of all reporting groups
88153|NCT01659268|B2|Baseline|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88154|NCT01659268|B1|Baseline|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88155|NCT01659268|P2|Participant Flow|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88156|NCT01659268|P1|Participant Flow|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88157|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88158|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88159|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88160|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88161|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88162|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88163|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88164|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88165|NCT01659268|E2|Reported Event|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
88166|NCT01659268|E1|Reported Event|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
88167|NCT01659125|B1|Baseline|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
88170|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
88270|NCT01658579|B4|Baseline|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
88171|NCT01659125|E1|Reported Event|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
88172|NCT01658943|B3|Baseline|Total|Total of all reporting groups
88173|NCT01658943|B2|Baseline|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88174|NCT01658943|B1|Baseline|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88175|NCT01658943|P2|Participant Flow|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88176|NCT01658943|P1|Participant Flow|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88177|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88178|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88179|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88180|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88181|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88182|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88183|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88184|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88185|NCT01658943|E2|Reported Event|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88186|NCT01658943|E1|Reported Event|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
88187|NCT01658904|B4|Baseline|Total|Total of all reporting groups
88188|NCT01658904|B3|Baseline|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88189|NCT01658904|B2|Baseline|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88190|NCT01658904|B1|Baseline|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88191|NCT01658904|P3|Participant Flow|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88223|NCT01658813|O1|Outcome|Number of Responders|the number of patients responding
88224|NCT01658813|O1|Outcome|Progression Free Survival|5-Fluorouracil and Interferon-alfa-2b
88192|NCT01658904|P2|Participant Flow|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88193|NCT01658904|P1|Participant Flow|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88194|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88195|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88196|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88197|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
88198|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
88199|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
88200|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88201|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88225|NCT01658813|E1|Reported Event|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
88226|NCT01658735|B4|Baseline|Total|Total of all reporting groups
88227|NCT01658735|B3|Baseline|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88202|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88203|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88204|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88205|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88206|NCT01658904|E3|Reported Event|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88207|NCT01658904|E2|Reported Event|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88208|NCT01658904|E1|Reported Event|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
88209|NCT01658839|B1|Baseline|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88210|NCT01658839|P1|Participant Flow|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88211|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88212|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88213|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88214|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88215|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88216|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88217|NCT01658839|E1|Reported Event|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
88218|NCT01658813|B1|Baseline|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
88219|NCT01658813|P1|Participant Flow|5-FU and Interferon-alfa-2b|All patients received 5-Fluorouracil and Interferon-alfa-2b
88220|NCT01658813|O1|Outcome|Median Survival|The median survival of patients treated on study was determined.
88221|NCT01658813|O1|Outcome|Median Duration of Response|The median duration of response was determined.
88222|NCT01658813|O1|Outcome|Response Rate|percentage of patients responding
88228|NCT01658735|B2|Baseline|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88229|NCT01658735|B1|Baseline|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88230|NCT01658735|P3|Participant Flow|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88231|NCT01658735|P2|Participant Flow|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88232|NCT01658735|P1|Participant Flow|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88233|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88234|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88235|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88236|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88237|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88238|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88239|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88240|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88241|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88242|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88243|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88244|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88245|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88246|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88247|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88248|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88249|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88250|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88251|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88252|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88253|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88254|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88255|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88256|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88257|NCT01658735|E3|Reported Event|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
88258|NCT01658735|E2|Reported Event|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
88259|NCT01658735|E1|Reported Event|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
88260|NCT01658657|B3|Baseline|Total|Total of all reporting groups
88261|NCT01658657|B2|Baseline|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
88262|NCT01658657|B1|Baseline|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
88263|NCT01658657|P2|Participant Flow|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
88264|NCT01658657|P1|Participant Flow|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
88265|NCT01658657|O2|Outcome|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
88266|NCT01658657|O1|Outcome|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
88267|NCT01658657|E2|Reported Event|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
88268|NCT01658657|E1|Reported Event|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
88269|NCT01658579|B5|Baseline|Total|Total of all reporting groups
88271|NCT01658579|B3|Baseline|Lantus Morning Then Evening|Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
88272|NCT01658579|B2|Baseline|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
88273|NCT01658579|B1|Baseline|HOE901-U300 Morning Then Evening|HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
88274|NCT01658579|P4|Participant Flow|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
88275|NCT01658579|P3|Participant Flow|Lantus Morning Then Evening|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
88276|NCT01658579|P2|Participant Flow|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
88277|NCT01658579|P1|Participant Flow|HOE901-U300 Morning Then Evening|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80–130 milligram per deciliter [mg/dL]).
88278|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88279|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88280|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88281|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88282|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88283|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88284|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88285|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88286|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88287|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88288|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88289|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88290|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88291|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88292|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88293|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88294|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88295|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88296|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88297|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88298|NCT01658579|E2|Reported Event|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88299|NCT01658579|E1|Reported Event|HOE901-U300 Combined|HOE901­U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
88300|NCT01658514|B5|Baseline|Total|Total of all reporting groups
88301|NCT01658514|B4|Baseline|Severe RI|Severe Renal Impairment = eGFR ≥15 to <30 mL/min/1.73 m²
88305|NCT01658514|P3|Participant Flow|Sequence BCA|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
88306|NCT01658514|P2|Participant Flow|Sequence CAB|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
88307|NCT01658514|P1|Participant Flow|Sequence ABC|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
88308|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
88309|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
88310|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
88311|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
88312|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
88313|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
88314|NCT01658514|E3|Reported Event|Met XR|One dose of 1000 mg Metformin Extended-Release
88315|NCT01658514|E2|Reported Event|Met DR|One dose of 1000 mg Metformin Delayed-Release
88316|NCT01658514|E1|Reported Event|Placebo|One dose of Placebo
88317|NCT01658436|B1|Baseline|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
88318|NCT01658436|P2|Participant Flow|BEZ235 400 mg Bid|Oral BEZ235 400 mg bid was investigated in stage 1 of study
88319|NCT01658436|P1|Participant Flow|BEZ235 300 mg|Oral BEZ235 300 mg bid was investigated in stage 1 of study
88320|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
88321|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
88322|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
88323|NCT01658436|E2|Reported Event|BEZ235 400 mg Bid|BEZ235 400 mg bid
88324|NCT01658436|E1|Reported Event|BEZ235 300 mg Bid|BEZ235 300 mg bid
88325|NCT01658072|B3|Baseline|Total|Total of all reporting groups
88326|NCT01658072|B2|Baseline|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
88327|NCT01658072|B1|Baseline|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
88328|NCT01658072|P2|Participant Flow|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
88329|NCT01658072|P1|Participant Flow|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
88330|NCT01658072|O2|Outcome|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
88331|NCT01658072|O1|Outcome|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
88332|NCT01658072|E2|Reported Event|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
88333|NCT01658072|E1|Reported Event|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
88334|NCT01658020|B3|Baseline|Total|Total of all reporting groups
88335|NCT01658020|B2|Baseline|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88336|NCT01658020|B1|Baseline|DW224|Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days
88337|NCT01658020|P2|Participant Flow|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7days
88338|NCT01658020|P1|Participant Flow|DW224|Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily
88339|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88340|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88341|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88342|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88343|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88344|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88345|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88346|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88347|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily 7 days
88348|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88349|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
88350|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
88351|NCT01658020|E2|Reported Event|Avelox|"Moxifloxacin Tablet 400mg given by oral administration~Zabofloxacin Tablet 400mg: multiple-dose"
88352|NCT01658020|E1|Reported Event|DW224|"Zabofloxacin Tablet 400mg given by oral administration~Moxifloxacin Tablet 400mg: multiple-dose"
88353|NCT01657903|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
88354|NCT01657903|P1|Participant Flow|Overall|This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
88355|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
88356|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88357|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88358|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88359|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
88360|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88361|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88362|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88363|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
88364|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88365|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88366|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88367|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
88368|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88369|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88370|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88371|NCT01657903|E4|Reported Event|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
88372|NCT01657903|E3|Reported Event|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88373|NCT01657903|E2|Reported Event|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
88374|NCT01657903|E1|Reported Event|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
88375|NCT01657877|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics.
88376|NCT01657877|P1|Participant Flow|Overall Participants|"In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:~Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)~Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 0 ppm fluoride + 0% CSP~Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period."
88377|NCT01657877|O2|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88378|NCT01657877|O1|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88379|NCT01657877|O5|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88380|NCT01657877|O4|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88381|NCT01657877|O3|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88382|NCT01657877|O2|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88383|NCT01657877|O1|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88384|NCT01657877|O3|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88385|NCT01657877|O2|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88386|NCT01657877|O1|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88387|NCT01657877|E5|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88388|NCT01657877|E4|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88389|NCT01657877|E3|Reported Event|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88390|NCT01657877|E2|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88391|NCT01657877|E1|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
88392|NCT01657370|B7|Baseline|Total|Total of all reporting groups
88393|NCT01657370|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88394|NCT01657370|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88395|NCT01657370|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88396|NCT01657370|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88397|NCT01657370|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88398|NCT01657370|B1|Baseline|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88399|NCT01657370|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88400|NCT01657370|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88401|NCT01657370|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88402|NCT01657370|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88403|NCT01657370|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88404|NCT01657370|P1|Participant Flow|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88405|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88406|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88407|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88408|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88409|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88410|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88411|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88412|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88612|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88613|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88413|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88414|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88415|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88416|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88417|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88418|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88419|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88420|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88421|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88422|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88423|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88424|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88425|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88426|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88427|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88428|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88429|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88430|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88431|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88432|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88433|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88434|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88435|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88436|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88437|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88438|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88614|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88439|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88440|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88441|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88442|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88443|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88444|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88445|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88446|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88447|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88448|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88449|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88450|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88451|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88452|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88453|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88454|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88455|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88456|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88457|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88458|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88459|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88460|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88461|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88462|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88463|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88464|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88615|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88465|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88466|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88467|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88468|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88469|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88470|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88471|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88472|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88473|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88474|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88475|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88476|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88477|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88478|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88479|NCT01657370|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88480|NCT01657370|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88481|NCT01657370|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88482|NCT01657370|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88483|NCT01657370|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88484|NCT01657370|E1|Reported Event|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
88485|NCT01657292|B1|Baseline|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
88486|NCT01657292|P1|Participant Flow|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
88487|NCT01657292|O1|Outcome|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
88488|NCT01657292|E4|Reported Event|Localized AE Both Wound Halves|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
88489|NCT01657292|E3|Reported Event|Octenilin Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
88490|NCT01657292|E2|Reported Event|Oleogel-S10 Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
88491|NCT01657292|E1|Reported Event|Entire Study Population - Systemic AEs|All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
88492|NCT01657032|B3|Baseline|Total|Total of all reporting groups
88616|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88617|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88493|NCT01657032|B2|Baseline|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88494|NCT01657032|B1|Baseline|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88495|NCT01657032|P2|Participant Flow|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88496|NCT01657032|P1|Participant Flow|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88497|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88498|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88499|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88500|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88501|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88502|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88503|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88504|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88505|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88538|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88506|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88507|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88508|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88509|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88510|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88511|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88512|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88513|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88514|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88515|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88516|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88517|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88518|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88539|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88618|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88519|NCT01657032|E2|Reported Event|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88520|NCT01657032|E1|Reported Event|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
88521|NCT01657019|B1|Baseline|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88522|NCT01657019|P1|Participant Flow|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88523|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88524|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88525|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88526|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88527|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88528|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88529|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88530|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88531|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88532|NCT01657019|E1|Reported Event|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
88533|NCT01656967|B3|Baseline|Total|Total of all reporting groups
88534|NCT01656967|B2|Baseline|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88535|NCT01656967|B1|Baseline|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88536|NCT01656967|P2|Participant Flow|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88537|NCT01656967|P1|Participant Flow|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88540|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
88541|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
88542|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
88543|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
88544|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88545|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88546|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88547|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88548|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88549|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88550|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88551|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88552|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88553|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88554|NCT01656967|E2|Reported Event|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
88555|NCT01656967|E1|Reported Event|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
88556|NCT01656889|B3|Baseline|Total|Total of all reporting groups
88557|NCT01656889|B2|Baseline|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88558|NCT01656889|B1|Baseline|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88559|NCT01656889|P2|Participant Flow|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88560|NCT01656889|P1|Participant Flow|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88561|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88562|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88563|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88564|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88565|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88611|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88619|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88566|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88567|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88568|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88569|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88570|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88571|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88572|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88573|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88574|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88575|NCT01656889|E2|Reported Event|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
88576|NCT01656889|E1|Reported Event|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
88577|NCT01656850|B3|Baseline|Total|Total of all reporting groups
88578|NCT01656850|B2|Baseline|NCEP Diet First, Then Almond Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
88579|NCT01656850|B1|Baseline|Almond Diet First, Then NCEP Diet|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
88580|NCT01656850|P2|Participant Flow|NCEP Diet First, Then Whole Almonds Diet|run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
88581|NCT01656850|P1|Participant Flow|Whole Almonds First, Then NCEP Diet|run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)
88582|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88583|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88584|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88585|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88586|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88587|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88588|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88589|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88590|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88591|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88592|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88593|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88594|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88595|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88596|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88597|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88598|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88599|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88600|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88601|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88602|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88603|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88604|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88605|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88606|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88607|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88608|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88609|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88610|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88620|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88621|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88622|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88623|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88624|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88625|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88626|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88627|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88628|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88629|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88630|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88631|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88632|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88633|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88634|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88635|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88636|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88637|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88638|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88639|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88640|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88641|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88642|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88643|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88644|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88645|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88646|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
88647|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
88648|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
88649|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
88650|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
88651|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
88652|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
88653|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
88654|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
88655|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
88656|NCT01656850|E2|Reported Event|NCEP Diet|participants received NCEP diet for 3 months
88657|NCT01656850|E1|Reported Event|Whole Almond Diet|participants received experiment diet containing 20% calorie from whole almond
88658|NCT01656772|B3|Baseline|Total|Total of all reporting groups
88659|NCT01656772|B2|Baseline|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
88660|NCT01656772|B1|Baseline|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
88661|NCT01656772|P2|Participant Flow|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
88662|NCT01656772|P1|Participant Flow|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
88663|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
88664|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
88665|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
88666|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
88667|NCT01656772|E2|Reported Event|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
88668|NCT01656772|E1|Reported Event|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
88669|NCT01656759|B3|Baseline|Total|Total of all reporting groups
88670|NCT01656759|B2|Baseline|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88671|NCT01656759|B1|Baseline|Control Group|Control group. Will not receive the fibrin spray.
88672|NCT01656759|P2|Participant Flow|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88673|NCT01656759|P1|Participant Flow|Control Group|Control group. Will not receive the fibrin spray.
88674|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88675|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
88676|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88677|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
88678|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88679|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
88680|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88681|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
88682|NCT01656759|E2|Reported Event|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
88683|NCT01656759|E1|Reported Event|Control Group|Control group. Will not receive the fibrin spray.
88684|NCT01656486|B1|Baseline|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
88685|NCT01656486|P1|Participant Flow|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
88686|NCT01656486|O1|Outcome|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
88687|NCT01656486|E1|Reported Event|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
88688|NCT01656460|B1|Baseline|Stereotactic Radiation|stereotactic
88689|NCT01656460|P4|Participant Flow|Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
88690|NCT01656460|P3|Participant Flow|Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
88691|NCT01656460|P2|Participant Flow|Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
88692|NCT01656460|P1|Participant Flow|Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
88693|NCT01656460|O4|Outcome|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
88694|NCT01656460|O3|Outcome|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
88695|NCT01656460|O2|Outcome|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
88696|NCT01656460|O1|Outcome|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
88697|NCT01656460|E4|Reported Event|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
88698|NCT01656460|E3|Reported Event|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
88699|NCT01656460|E2|Reported Event|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
88700|NCT01656460|E1|Reported Event|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
88701|NCT01656434|B3|Baseline|Total|Total of all reporting groups
88702|NCT01656434|B2|Baseline|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88703|NCT01656434|B1|Baseline|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88704|NCT01656434|P2|Participant Flow|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88705|NCT01656434|P1|Participant Flow|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88925|NCT01656408|E3|Reported Event|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88706|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88707|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88708|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88709|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88710|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88711|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88712|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88713|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88714|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88715|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88716|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88717|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88718|NCT01656434|E2|Reported Event|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
88719|NCT01656434|E1|Reported Event|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
88720|NCT01656408|B11|Baseline|Total|Total of all reporting groups
88721|NCT01656408|B10|Baseline|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88722|NCT01656408|B9|Baseline|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88723|NCT01656408|B8|Baseline|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
88724|NCT01656408|B7|Baseline|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88725|NCT01656408|B6|Baseline|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
88726|NCT01656408|B5|Baseline|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
88727|NCT01656408|B4|Baseline|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88728|NCT01656408|B3|Baseline|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88729|NCT01656408|B2|Baseline|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88730|NCT01656408|B1|Baseline|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88731|NCT01656408|P10|Participant Flow|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88732|NCT01656408|P9|Participant Flow|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88733|NCT01656408|P8|Participant Flow|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
88734|NCT01656408|P7|Participant Flow|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
88735|NCT01656408|P6|Participant Flow|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
88736|NCT01656408|P5|Participant Flow|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
88737|NCT01656408|P4|Participant Flow|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88738|NCT01656408|P3|Participant Flow|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88739|NCT01656408|P2|Participant Flow|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88740|NCT01656408|P1|Participant Flow|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
88741|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88742|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88743|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88744|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88745|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88746|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88747|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88748|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88749|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88750|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88751|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88752|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88753|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88754|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88755|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88756|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88757|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88758|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88759|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88760|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88761|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88762|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88763|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88764|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88765|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88766|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88767|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88768|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88769|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88770|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88771|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88772|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88773|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88774|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88775|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88776|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88777|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88778|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88779|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88780|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88781|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88782|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88783|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88784|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88785|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88786|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88787|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88788|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88789|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88790|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88791|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88792|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88793|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88794|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88795|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88796|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88797|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88798|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88799|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88800|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88801|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88802|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88803|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88804|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88805|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88806|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88807|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88808|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88809|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88810|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88811|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88812|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88813|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88814|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88815|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88816|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88817|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88818|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88819|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88820|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88821|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88822|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88823|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88824|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88825|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
88826|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
88827|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
88828|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
88829|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
88830|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
88831|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
88832|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
88833|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
88834|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
88835|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
88836|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
88837|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
88838|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
88839|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
88840|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
88841|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88842|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88843|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88844|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88845|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88846|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88847|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88848|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88849|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88850|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88851|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88852|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88853|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88854|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88855|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88856|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88857|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88858|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88859|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
88860|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88861|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88862|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88863|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
88864|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88865|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88866|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88867|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
88868|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88869|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88870|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88871|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
88872|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88873|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88874|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88875|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88876|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88877|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88878|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88879|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
88880|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88881|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88882|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88883|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88884|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88885|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88886|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
88887|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88888|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88889|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88890|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88891|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
88892|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88893|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88894|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88895|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88896|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88897|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88898|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88899|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88900|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88901|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88902|NCT01656408|O13|Outcome|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
88903|NCT01656408|O12|Outcome|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
88904|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
88905|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88906|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88907|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88908|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88909|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88910|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88911|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88912|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
88913|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88914|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88915|NCT01656408|E13|Reported Event|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
88916|NCT01656408|E12|Reported Event|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
88917|NCT01656408|E11|Reported Event|Placebo (Panel A - J)|Combines participants who received placebo in all panels
88918|NCT01656408|E10|Reported Event|Panel J – MK-8150 10/20 mgEdit|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
88919|NCT01656408|E9|Reported Event|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
88920|NCT01656408|E8|Reported Event|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
88921|NCT01656408|E7|Reported Event|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
88922|NCT01656408|E6|Reported Event|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
88923|NCT01656408|E5|Reported Event|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
88924|NCT01656408|E4|Reported Event|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
88926|NCT01656408|E2|Reported Event|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
88927|NCT01656408|E1|Reported Event|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
88928|NCT01656304|B1|Baseline|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88929|NCT01656304|P1|Participant Flow|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88930|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88931|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88932|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88933|NCT01656304|E1|Reported Event|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
88934|NCT01656161|B1|Baseline|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
88935|NCT01656161|P1|Participant Flow|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
88936|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
88937|NCT01656161|O1|Outcome|PK/PD Subset of 15 Participants|Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
88938|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
88939|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
88940|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
88941|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
88942|NCT01656161|O1|Outcome|PK/PD Subset|Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.
88943|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
88944|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
88945|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
88946|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
88947|NCT01656161|E1|Reported Event|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
88948|NCT01656031|B1|Baseline|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
88949|NCT01656031|P1|Participant Flow|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
88950|NCT01656031|O1|Outcome|High-Dose Cytarabine and Clofarabine|
88951|NCT01656031|E1|Reported Event|High-Dose Cytarabine and Clofarabine|
88952|NCT01655498|B1|Baseline|All Subjects|All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
88953|NCT01655498|P1|Participant Flow|All Subjects|All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
88954|NCT01655498|O1|Outcome|ITT Cohort [N=61]|All subjects who entered the Treatment Period.
88955|NCT01655498|O1|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
88956|NCT01655498|O2|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
88957|NCT01655498|O1|Outcome|Subjects Fit With the VBC Device [ITT]|ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period
88958|NCT01655498|E1|Reported Event|ITT Cohort [N=61]|Adverse Events reported during the Screening and 1-Month Treatment Period.
88959|NCT01655381|B1|Baseline|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88960|NCT01655381|P1|Participant Flow|Tocilizumab|Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
88961|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
88962|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
88963|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88964|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88965|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88966|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88967|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88968|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88969|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88970|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88971|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88972|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88973|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88974|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88975|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88976|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88977|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88978|NCT01655381|E1|Reported Event|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
88979|NCT01655329|B1|Baseline|Radiologists|Board Certified Radiologists
88980|NCT01655329|P1|Participant Flow|Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation
88981|NCT01655329|O9|Outcome|Confidence on Tube Placement|The confirm image increases my confidence with respect to tube placement.
88982|NCT01655329|O8|Outcome|Need for Window/Level Manipulation|The standard image required less window/level manipulation
88983|NCT01655329|O7|Outcome|Confidence on Line Placement|The modified image increased my confidence with respect to line placement
88984|NCT01655329|O6|Outcome|Image Quality Radioopaque Regions|Image quality in the opaque image areas is superior on the confirm image
88985|NCT01655329|O5|Outcome|Overall Image Quality|Overall image quality is superior on the standard image
88986|NCT01655329|O4|Outcome|Cardiac Related Wires|Cardiac related wires are easier to see on the standard image
88987|NCT01655329|O3|Outcome|Venous Catheters|Venous catheters easier to see on modified image
88988|NCT01655329|O2|Outcome|Pleural Drain Visibility|Pleural drains are easier to see on the standard image.
88989|NCT01655329|O1|Outcome|Reading Time Estimate by Radiologists|The modified image will reduce reading time.
88990|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
88991|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
88992|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
88993|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
88994|NCT01655329|E1|Reported Event|Radiologists|
88995|NCT01655043|B1|Baseline|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
88996|NCT01655043|P1|Participant Flow|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
88997|NCT01655043|O1|Outcome|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
88998|NCT01655043|E1|Reported Event|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
88999|NCT01654861|B1|Baseline|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
89000|NCT01654861|P1|Participant Flow|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
89001|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
89002|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
89003|NCT01654861|E1|Reported Event|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
89004|NCT01654666|B4|Baseline|Total|Total of all reporting groups
89005|NCT01654666|B3|Baseline|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89006|NCT01654666|B2|Baseline|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89007|NCT01654666|B1|Baseline|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89008|NCT01654666|P3|Participant Flow|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89009|NCT01654666|P2|Participant Flow|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89010|NCT01654666|P1|Participant Flow|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89011|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89012|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89013|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89014|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89015|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89016|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89017|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89018|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89019|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89020|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89021|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89022|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89023|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89024|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89025|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89026|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89027|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89028|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89029|NCT01654666|E3|Reported Event|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89030|NCT01654666|E2|Reported Event|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89031|NCT01654666|E1|Reported Event|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
89032|NCT01654601|B3|Baseline|Total|Total of all reporting groups
89033|NCT01654601|B2|Baseline|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89034|NCT01654601|B1|Baseline|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89035|NCT01654601|P2|Participant Flow|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89036|NCT01654601|P1|Participant Flow|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89037|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89038|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89039|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89040|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89041|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89042|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89043|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89044|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
89045|NCT01654601|E2|Reported Event|B Group|1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
89046|NCT01654601|E1|Reported Event|A Group|1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
89047|NCT01654549|B3|Baseline|Total|Total of all reporting groups
89048|NCT01654549|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
89049|NCT01654549|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
89050|NCT01654549|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
89051|NCT01654549|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
89052|NCT01654549|O6|Outcome|Liver Fat Content Change in Lifestyle Modification|The change of liver fat content from baseline to the end of study in lifestyle modification group
89053|NCT01654549|O5|Outcome|Liver Fat Content Change in H.Pylori Eradication|The change of liver fat content from baseline to the end of study in H.pylori eradication group
89054|NCT01654549|O4|Outcome|Liver Fat Content in Lifestyle Modification at 8 Weeks|Liver fat content in lifestyle modification group at 8 weeks
89055|NCT01654549|O3|Outcome|Liver Fat Content in Lifestyle Modification at Baseline|Liver fat content in lifestyle modification group at baseline
89056|NCT01654549|O2|Outcome|Liver Fat Content in H.Pylori Eradication at 8 Weeks|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
89057|NCT01654549|O1|Outcome|Liver Fat Content in H.Pylori Eradication at Baseline|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
89058|NCT01654549|E2|Reported Event|No Intervention|Lifestyle modification
89059|NCT01654549|E1|Reported Event|H. Pylori Eradication|Helicobacter pylori eradication
89060|NCT01654536|B3|Baseline|Total|Total of all reporting groups
89061|NCT01654536|B2|Baseline|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89062|NCT01654536|B1|Baseline|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89063|NCT01654536|P2|Participant Flow|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89064|NCT01654536|P1|Participant Flow|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89065|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89066|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89067|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89068|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89069|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89070|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89071|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89072|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89073|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89074|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89075|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89076|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89077|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89078|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89079|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89080|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89081|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89082|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89083|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89084|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89085|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89086|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetona (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89087|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89088|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89089|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89090|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89091|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89092|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89093|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89094|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89095|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89096|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89097|NCT01654536|E2|Reported Event|Ciclesonide Nasal Spray|"ciclesonide nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
89098|NCT01654536|E1|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
89099|NCT01654523|B1|Baseline|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
89100|NCT01654523|P1|Participant Flow|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
89101|NCT01654523|O1|Outcome|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
89102|NCT01654523|E1|Reported Event|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
89103|NCT01654302|B3|Baseline|Total|Total of all reporting groups
89104|NCT01654302|B2|Baseline|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
89105|NCT01654302|B1|Baseline|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
89106|NCT01654302|P2|Participant Flow|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
89107|NCT01654302|P1|Participant Flow|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
89108|NCT01654302|O2|Outcome|Inactive Patch|placebo: placebo
89109|NCT01654302|O1|Outcome|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
89110|NCT01654302|E2|Reported Event|Inactive Patch|placebo: placebo
89111|NCT01654302|E1|Reported Event|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
89112|NCT01654276|B1|Baseline|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89113|NCT01654276|P1|Participant Flow|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89114|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89115|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89116|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89117|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89118|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89119|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89120|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89121|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89122|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89123|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89124|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89125|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89126|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89127|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89128|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89823|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89129|NCT01654276|E1|Reported Event|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
89130|NCT01654263|B7|Baseline|Total|Total of all reporting groups
89131|NCT01654263|B6|Baseline|IIBB: Age 65-74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89132|NCT01654263|B5|Baseline|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89133|NCT01654263|B4|Baseline|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89134|NCT01654263|B3|Baseline|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89135|NCT01654263|B2|Baseline|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
89136|NCT01654263|B1|Baseline|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
89137|NCT01654263|P6|Participant Flow|IIBB: Age 65 - 74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89138|NCT01654263|P5|Participant Flow|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89139|NCT01654263|P4|Participant Flow|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89140|NCT01654263|P3|Participant Flow|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89141|NCT01654263|P2|Participant Flow|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
89142|NCT01654263|P1|Participant Flow|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
89143|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89144|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89145|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
89146|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89147|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89148|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
89149|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89150|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89151|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
89152|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89153|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89154|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
89155|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89824|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89156|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89157|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
89158|NCT01654263|E6|Reported Event|IIBB: Previous PPSV23, Age 65-74, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89159|NCT01654263|E5|Reported Event|IIAA: Previous PPSV23, Age 55-64, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89160|NCT01654263|E4|Reported Event|IIB: Previous PPSV23, Age 65-74, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89161|NCT01654263|E3|Reported Event|IIA: Previous PPSV23, Age 55-64, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
89162|NCT01654263|E2|Reported Event|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
89163|NCT01654263|E1|Reported Event|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
89164|NCT01654250|B3|Baseline|Total|Total of all reporting groups
89165|NCT01654250|B2|Baseline|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89166|NCT01654250|B1|Baseline|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89167|NCT01654250|P2|Participant Flow|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89168|NCT01654250|P1|Participant Flow|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89169|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89170|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89171|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89172|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89173|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89174|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89175|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89176|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89177|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89178|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89179|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89180|NCT01654250|E2|Reported Event|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89181|NCT01654250|E1|Reported Event|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
89182|NCT01654224|B3|Baseline|Total|Total of all reporting groups
89183|NCT01654224|B2|Baseline|SD IIV|Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly
89184|NCT01654224|B1|Baseline|HD IIV|Frail adults 65 years and older who received Fluzone High Dose intramuscularly
89185|NCT01654224|P2|Participant Flow|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
89186|NCT01654224|P1|Participant Flow|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
89187|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
89188|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
89189|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
89190|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
89191|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
89192|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
89193|NCT01654224|E2|Reported Event|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
89194|NCT01654224|E1|Reported Event|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
89195|NCT01654107|B3|Baseline|Total|Total of all reporting groups
89196|NCT01654107|B2|Baseline|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89197|NCT01654107|B1|Baseline|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89198|NCT01654107|P2|Participant Flow|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89199|NCT01654107|P1|Participant Flow|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89200|NCT01654107|O2|Outcome|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89201|NCT01654107|O1|Outcome|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89202|NCT01654107|E2|Reported Event|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89203|NCT01654107|E1|Reported Event|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
89204|NCT01653782|B4|Baseline|Total|Total of all reporting groups
89205|NCT01653782|B3|Baseline|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
89206|NCT01653782|B2|Baseline|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
89207|NCT01653782|B1|Baseline|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
89619|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89208|NCT01653782|P3|Participant Flow|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
89209|NCT01653782|P2|Participant Flow|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
89210|NCT01653782|P1|Participant Flow|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
89211|NCT01653782|O3|Outcome|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
89212|NCT01653782|O2|Outcome|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
89213|NCT01653782|O1|Outcome|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
89214|NCT01653782|E3|Reported Event|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
89215|NCT01653782|E2|Reported Event|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
89216|NCT01653782|E1|Reported Event|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
89217|NCT01653743|B3|Baseline|Total|Total of all reporting groups
89218|NCT01653743|B2|Baseline|Urinary Human Chorionic Gonadotropin (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89219|NCT01653743|B1|Baseline|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89220|NCT01653743|P2|Participant Flow|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89221|NCT01653743|P1|Participant Flow|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89222|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89223|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89224|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89238|NCT01653509|P1|Participant Flow|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89620|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
89225|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89226|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89227|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89228|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89229|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89230|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89231|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89232|NCT01653743|E2|Reported Event|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
89233|NCT01653743|E1|Reported Event|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
89234|NCT01653509|B3|Baseline|Total|Total of all reporting groups
89235|NCT01653509|B2|Baseline|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
89236|NCT01653509|B1|Baseline|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
89237|NCT01653509|P2|Participant Flow|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89239|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
89240|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
89241|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89242|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89243|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89244|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89245|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89246|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89247|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89248|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89249|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89250|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89251|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89252|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
89253|NCT01653509|E2|Reported Event|Placebo Patch|Participants applied single placebo patch to the cold sore area.
89254|NCT01653509|E1|Reported Event|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area.
89255|NCT01653418|B1|Baseline|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89256|NCT01653418|P1|Participant Flow|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89257|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89258|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89259|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89260|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89261|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89262|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89263|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89264|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89265|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89266|NCT01653418|E1|Reported Event|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
89284|NCT01653158|P5|Participant Flow|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89621|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89267|NCT01653262|B1|Baseline|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89268|NCT01653262|P1|Participant Flow|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89269|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89270|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89271|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89272|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89273|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89274|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89275|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89276|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89277|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89278|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89279|NCT01653262|E1|Reported Event|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
89280|NCT01653158|B1|Baseline|Entire Study Population|Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
89281|NCT01653158|P8|Participant Flow|CP-751,871 20 mg/kg + Docetaxel|"In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).~In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1."
89282|NCT01653158|P7|Participant Flow|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89283|NCT01653158|P6|Participant Flow|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89285|NCT01653158|P4|Participant Flow|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89286|NCT01653158|P3|Participant Flow|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89287|NCT01653158|P2|Participant Flow|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89288|NCT01653158|P1|Participant Flow|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89289|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89290|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89291|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89292|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89293|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89294|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89295|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89296|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89297|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89298|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89299|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89300|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89301|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89302|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89303|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89304|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89305|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89306|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89307|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89308|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89309|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89310|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89311|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89340|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89312|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89313|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89314|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89315|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89316|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89317|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89318|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89319|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89320|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89321|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89322|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89323|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89324|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89325|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89326|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89327|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89328|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89329|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89330|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89331|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89332|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89333|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89334|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89335|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89336|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89337|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89338|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89339|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89341|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89342|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89343|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89344|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89345|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89346|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89347|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89348|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89349|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89350|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89351|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89352|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89353|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89354|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89355|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89356|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89357|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89358|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89359|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89360|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89361|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89362|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89363|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89364|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89365|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89366|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89367|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89368|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89369|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89370|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89371|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89372|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89373|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89374|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89375|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89376|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89377|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89378|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89379|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89380|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89381|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89382|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89383|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89384|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89385|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89386|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89387|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89388|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89389|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89390|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89391|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89392|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89393|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89394|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89395|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89396|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89397|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89398|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89399|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89400|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89401|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89402|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89403|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89404|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89405|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89406|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89407|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89408|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89409|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89410|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89411|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89412|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89413|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89414|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89415|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89416|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89417|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89418|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89419|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89420|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89421|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89422|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89423|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89424|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89425|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89426|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89427|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89428|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89429|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89430|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89431|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89432|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89433|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89434|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89435|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89436|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89437|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89438|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89439|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89440|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89441|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89442|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89443|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89444|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89445|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89446|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89447|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89448|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89449|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89450|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89451|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89452|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89453|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89454|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89455|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89456|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89457|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89458|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89459|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89460|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89461|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89462|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89463|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89464|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89465|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89466|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89467|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89468|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89469|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89470|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89471|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89472|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89473|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89474|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89475|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89476|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89477|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89478|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89479|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89480|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89481|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89482|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89483|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89484|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89485|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89486|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89487|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89488|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89489|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89490|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89491|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89492|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89493|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89494|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89495|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89496|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89497|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89498|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89499|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89500|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89501|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89502|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89503|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89504|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89505|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89506|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89507|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89508|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89509|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89510|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89511|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89512|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89513|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89514|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89515|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89516|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89517|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89518|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89519|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89520|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89521|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89522|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89523|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89524|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89525|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89526|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89527|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89528|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89529|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89530|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89531|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89532|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89533|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89534|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89535|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89536|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89537|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89538|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89539|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89540|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89541|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89542|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89543|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89544|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89545|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89546|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89547|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89548|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
89549|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89550|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89579|NCT01653028|B1|Baseline|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89819|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89551|NCT01653158|E8|Reported Event|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
89552|NCT01653158|E7|Reported Event|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89553|NCT01653158|E6|Reported Event|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89554|NCT01653158|E5|Reported Event|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89555|NCT01653158|E4|Reported Event|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89556|NCT01653158|E3|Reported Event|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89557|NCT01653158|E2|Reported Event|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
89558|NCT01653158|E1|Reported Event|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
89559|NCT01653132|B1|Baseline|All Study Participants|Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
89560|NCT01653132|P2|Participant Flow|Incobotulinum Toxin A First, Then Placebo|Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
89561|NCT01653132|P1|Participant Flow|Placebo First, Then Incobotulinum Toxin A|sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
89562|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
89563|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
89564|NCT01653132|O2|Outcome|Placebo|"Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .~Placebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands ."
89565|NCT01653132|O1|Outcome|Incobotulinum Toxin A|"Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks~Incobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks"
89566|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
89567|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
89568|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
89569|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
89570|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
89571|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
89572|NCT01653132|E2|Reported Event|Placebo|Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
89573|NCT01653132|E1|Reported Event|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
89574|NCT01653028|B6|Baseline|Total|Total of all reporting groups
89575|NCT01653028|B5|Baseline|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89576|NCT01653028|B4|Baseline|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89577|NCT01653028|B3|Baseline|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89578|NCT01653028|B2|Baseline|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89618|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89580|NCT01653028|P5|Participant Flow|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89581|NCT01653028|P4|Participant Flow|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89582|NCT01653028|P3|Participant Flow|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89583|NCT01653028|P2|Participant Flow|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89584|NCT01653028|P1|Participant Flow|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89585|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89586|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89587|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89588|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89589|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89590|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89591|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89592|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89593|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89594|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89595|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89596|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89597|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89598|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89599|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89600|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89601|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89602|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89603|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89604|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89605|NCT01653028|E5|Reported Event|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89606|NCT01653028|E4|Reported Event|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89607|NCT01653028|E3|Reported Event|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89608|NCT01653028|E2|Reported Event|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89609|NCT01653028|E1|Reported Event|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
89610|NCT01652729|B4|Baseline|Total|Total of all reporting groups
89611|NCT01652729|B3|Baseline|Placebo Comparator: Placebo|Placebo oral tablet once daily
89612|NCT01652729|B2|Baseline|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89613|NCT01652729|B1|Baseline|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89614|NCT01652729|P3|Participant Flow|Placebo Comparator: Placebo|Placebo oral tablet once daily
89615|NCT01652729|P2|Participant Flow|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89616|NCT01652729|P1|Participant Flow|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89617|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
89622|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89623|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
89624|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89625|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89626|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
89627|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89628|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89629|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
89630|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89631|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89632|NCT01652729|E3|Reported Event|Placebo Comparator: Placebo|Placebo oral tablet once daily
89633|NCT01652729|E2|Reported Event|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
89634|NCT01652729|E1|Reported Event|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
89635|NCT01652716|B3|Baseline|Total|Total of all reporting groups
89636|NCT01652716|B2|Baseline|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89637|NCT01652716|B1|Baseline|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89638|NCT01652716|P2|Participant Flow|Active Comparator: Exenatide Twice Daily (BID)|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89639|NCT01652716|P1|Participant Flow|Experimental: Exenatide Once Weekly (QWS) Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89640|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89641|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89642|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89643|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89644|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89645|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89646|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89647|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89648|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89649|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89650|NCT01652716|E2|Reported Event|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
89651|NCT01652716|E1|Reported Event|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
89652|NCT01652703|B7|Baseline|Total|Total of all reporting groups
89653|NCT01652703|B6|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89654|NCT01652703|B5|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89655|NCT01652703|B4|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89656|NCT01652703|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89657|NCT01652703|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89658|NCT01652703|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89659|NCT01652703|P6|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89660|NCT01652703|P5|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89661|NCT01652703|P4|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89662|NCT01652703|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89663|NCT01652703|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89664|NCT01652703|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89665|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89666|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89667|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89668|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89669|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89670|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89671|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89672|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89673|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89674|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89675|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89676|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89677|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89678|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89679|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89680|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89681|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89682|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89683|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89684|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89685|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89686|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89687|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89688|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89689|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89690|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89691|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89692|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89693|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89694|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89695|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89696|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89697|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89698|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89699|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89700|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89701|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89702|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89703|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89704|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89705|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89706|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89707|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89708|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89709|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89710|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89711|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89712|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89713|NCT01652703|E6|Reported Event|Evolocumab Q4W 420 MG|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89714|NCT01652703|E5|Reported Event|Evolocumab Q4W 280 MG|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
89715|NCT01652703|E4|Reported Event|Evolocumab Q2W 140 MG|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89716|NCT01652703|E3|Reported Event|Evolocumab Q2W 70 MG|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
89717|NCT01652703|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
89718|NCT01652703|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
89719|NCT01652690|B3|Baseline|Total|Total of all reporting groups
89720|NCT01652690|B2|Baseline|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89721|NCT01652690|B1|Baseline|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89722|NCT01652690|P2|Participant Flow|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89723|NCT01652690|P1|Participant Flow|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89724|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89725|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89726|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89727|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89728|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89729|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89730|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89731|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89732|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89733|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89734|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89735|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89736|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89737|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89738|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89739|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89740|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89741|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89742|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89743|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89744|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89745|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89746|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89747|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89820|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89748|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89749|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89750|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89751|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89752|NCT01652690|E2|Reported Event|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89753|NCT01652690|E1|Reported Event|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
89754|NCT01652664|B3|Baseline|Total|Total of all reporting groups
89755|NCT01652664|B2|Baseline|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
89756|NCT01652664|B1|Baseline|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
89757|NCT01652664|P2|Participant Flow|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
89758|NCT01652664|P1|Participant Flow|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
89759|NCT01652664|O2|Outcome|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
89760|NCT01652664|O1|Outcome|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
89761|NCT01652664|E3|Reported Event|Timolol|All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
89762|NCT01652664|E2|Reported Event|Travoprost|All participants who received travoprost with vehicle
89763|NCT01652664|E1|Reported Event|Pre-Treatment|All enrolled participants
89764|NCT01652495|B3|Baseline|Total|Total of all reporting groups
89765|NCT01652495|B2|Baseline|Triamcinolone Acetonide|Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
89766|NCT01652495|B1|Baseline|Methylprednisolone Acetate|Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
89767|NCT01652495|P2|Participant Flow|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
89768|NCT01652495|P1|Participant Flow|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
89769|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide"
89770|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate"
89771|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
89772|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
89773|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
89774|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
89775|NCT01652495|E2|Reported Event|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
89776|NCT01652495|E1|Reported Event|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
89777|NCT01652001|B3|Baseline|Total|Total of all reporting groups
89778|NCT01652001|B2|Baseline|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
89779|NCT01652001|B1|Baseline|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
89780|NCT01652001|P2|Participant Flow|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
89781|NCT01652001|P1|Participant Flow|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
89821|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89822|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89782|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
89783|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
89784|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
89785|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
89786|NCT01652001|E2|Reported Event|Control|Patients treated with a placebo
89787|NCT01652001|E1|Reported Event|Malic Acid 1%|Patients treated with Malic Acid 1%
89788|NCT01651949|B4|Baseline|Total|Total of all reporting groups
89789|NCT01651949|B3|Baseline|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89790|NCT01651949|B2|Baseline|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89791|NCT01651949|B1|Baseline|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89792|NCT01651949|P3|Participant Flow|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89793|NCT01651949|P2|Participant Flow|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89794|NCT01651949|P1|Participant Flow|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89795|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89796|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89797|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89798|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89799|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89800|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89801|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89802|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89803|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89804|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89805|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89806|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89807|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89808|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89809|NCT01651949|E2|Reported Event|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89810|NCT01651949|E1|Reported Event|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
89811|NCT01651351|B3|Baseline|Total|Total of all reporting groups
89812|NCT01651351|B2|Baseline|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
89813|NCT01651351|B1|Baseline|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
89814|NCT01651351|P2|Participant Flow|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
89815|NCT01651351|P1|Participant Flow|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
89816|NCT01651351|O1|Outcome|All Study Participants|
89817|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89818|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89825|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89826|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89827|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
89828|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
89829|NCT01651351|E2|Reported Event|GLASSIA Infusion Rate- 0.2 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min"
89830|NCT01651351|E1|Reported Event|GLASSIA Infusion Rate- 0.04 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min"
89831|NCT01651260|B1|Baseline|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
89832|NCT01651260|P1|Participant Flow|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
89833|NCT01651260|O1|Outcome|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
89834|NCT01651260|O1|Outcome|Hollister Endotracheal (ET) Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
89835|NCT01651260|E1|Reported Event|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
89836|NCT01651208|B3|Baseline|Total|Total of all reporting groups
89837|NCT01651208|B2|Baseline|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
89838|NCT01651208|B1|Baseline|Motivational Interviewing (MINT)|The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
89839|NCT01651208|P2|Participant Flow|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
89840|NCT01651208|P1|Participant Flow|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
89841|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
89842|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
89843|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
89844|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
89845|NCT01651208|E2|Reported Event|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
89846|NCT01651208|E1|Reported Event|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
89847|NCT01651104|B1|Baseline|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89848|NCT01651104|P1|Participant Flow|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89849|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89850|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89851|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89852|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89853|NCT01651104|E1|Reported Event|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
89854|NCT01651000|B3|Baseline|Total|Total of all reporting groups
89855|NCT01651000|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89856|NCT01651000|B1|Baseline|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89857|NCT01651000|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89858|NCT01651000|P1|Participant Flow|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89859|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89860|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89861|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89862|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89863|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89864|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89865|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89866|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89867|NCT01651000|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89868|NCT01651000|E1|Reported Event|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
89930|NCT01650324|P3|Participant Flow|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89869|NCT01650831|B1|Baseline|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
89870|NCT01650831|P1|Participant Flow|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
89871|NCT01650831|O2|Outcome|Negative Modified BreathID|The amount of subjects that produced negative results for H.pylori with modified BreathID.
89872|NCT01650831|O1|Outcome|Positive Modified BreathID|The amount of subjects that produced positive results for H.pylori with modified BreathID.
89873|NCT01650831|O2|Outcome|Marketed BreathID Negative|Cleared BreathID subjects that were found to be negative for H.pylori
89874|NCT01650831|O1|Outcome|Marketed BreathID Positive|Cleared BreathID subjects that were found to be positive for H.pylori
89875|NCT01650831|O1|Outcome|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
89876|NCT01650831|E1|Reported Event|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
89877|NCT01650805|B3|Baseline|Total|Total of all reporting groups
89878|NCT01650805|B2|Baseline|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89879|NCT01650805|B1|Baseline|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
89880|NCT01650805|P2|Participant Flow|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89881|NCT01650805|P1|Participant Flow|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
89882|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89883|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
89884|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89885|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
89886|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89887|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
89888|NCT01650805|E2|Reported Event|Imatinib 400 mg|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
89889|NCT01650805|E1|Reported Event|Ponatinib 45 mg|ponatinib: 45 mg tablet, taken orally once daily
89890|NCT01650779|B1|Baseline|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
89891|NCT01650779|P1|Participant Flow|Agalsidase Beta|Commercially available agalsidase beta (Fabrazyme ®) 1.0 milligram per kilogram (mg/kg) administered as an intravenous infusion every 2 weeks (q2w) up to Month 6.
89892|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
89893|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
89894|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
89895|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
89896|NCT01650779|E1|Reported Event|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion every 2 weeks up to Month 6.
89897|NCT01650519|B3|Baseline|Total|Total of all reporting groups
89898|NCT01650519|B2|Baseline|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89899|NCT01650519|B1|Baseline|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89900|NCT01650519|P2|Participant Flow|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89901|NCT01650519|P1|Participant Flow|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89902|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89903|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89904|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89905|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89906|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89907|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89908|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89909|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89910|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89911|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89912|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89913|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89914|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89915|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89916|NCT01650519|E2|Reported Event|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
89917|NCT01650519|E1|Reported Event|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
89918|NCT01650350|B1|Baseline|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
89919|NCT01650350|P1|Participant Flow|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
89920|NCT01650350|O1|Outcome|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
89921|NCT01650350|E1|Reported Event|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
89922|NCT01650324|B6|Baseline|Total|Total of all reporting groups
89923|NCT01650324|B5|Baseline|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89924|NCT01650324|B4|Baseline|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89925|NCT01650324|B3|Baseline|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89926|NCT01650324|B2|Baseline|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89927|NCT01650324|B1|Baseline|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
89928|NCT01650324|P5|Participant Flow|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89929|NCT01650324|P4|Participant Flow|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89931|NCT01650324|P2|Participant Flow|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89932|NCT01650324|P1|Participant Flow|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
89933|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89934|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89935|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89936|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89937|NCT01650324|O1|Outcome|Placebo|Participants received a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg or 600 mg.
89938|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89939|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89940|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89941|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89942|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89943|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89944|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89945|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89946|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89947|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89948|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89949|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89950|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89951|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89952|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89953|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89954|NCT01650324|O1|Outcome|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
89955|NCT01650324|E5|Reported Event|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
89956|NCT01650324|E4|Reported Event|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
89957|NCT01650324|E3|Reported Event|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
89958|NCT01650324|E2|Reported Event|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
89959|NCT01650324|E1|Reported Event|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
89960|NCT01650285|B1|Baseline|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
89961|NCT01650285|P1|Participant Flow|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
89962|NCT01650285|O1|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
89963|NCT01650285|E1|Reported Event|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
89964|NCT01650246|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
89965|NCT01650246|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
89966|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
89967|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
89968|NCT01650246|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
89969|NCT01649856|B3|Baseline|Total|Total of all reporting groups
89970|NCT01649856|B2|Baseline|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89971|NCT01649856|B1|Baseline|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90004|NCT01649804|B1|Baseline|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90005|NCT01649804|P1|Participant Flow|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90126|NCT01649232|O4|Outcome|Controls at 3 Months|Healthy people that not receive tDCS
89972|NCT01649856|P2|Participant Flow|Rituximab Intravenous (IV)|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89973|NCT01649856|P1|Participant Flow|Rituximab Subcutaneous (SC)|Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.
89974|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89975|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89976|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89977|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89978|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89979|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89980|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89981|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90006|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90007|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
89982|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89983|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89984|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89985|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89986|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89987|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89988|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89989|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89990|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89991|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89992|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89993|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89994|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89995|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89996|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89997|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89998|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
89999|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90000|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90001|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90002|NCT01649856|E2|Reported Event|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90003|NCT01649856|E1|Reported Event|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
90008|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90009|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90010|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90011|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90012|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90013|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90014|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90015|NCT01649804|E1|Reported Event|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
90016|NCT01649791|B1|Baseline|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90017|NCT01649791|P1|Participant Flow|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90018|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90019|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90020|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90021|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90022|NCT01649791|E1|Reported Event|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
90023|NCT01649557|B4|Baseline|Total|Total of all reporting groups
90024|NCT01649557|B3|Baseline|Prior Apripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90025|NCT01649557|B2|Baseline|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90026|NCT01649557|B1|Baseline|Prior Brexiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90027|NCT01649557|P3|Participant Flow|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90028|NCT01649557|P2|Participant Flow|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90029|NCT01649557|P1|Participant Flow|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90030|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90031|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90032|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90033|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90034|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90035|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90036|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90037|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90038|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90039|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90040|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90041|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90042|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90043|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90044|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90045|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90046|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90047|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90048|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90049|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90050|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90051|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90052|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90053|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90054|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90055|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90056|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90057|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90058|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90059|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90060|NCT01649557|E3|Reported Event|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90061|NCT01649557|E2|Reported Event|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90062|NCT01649557|E1|Reported Event|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
90063|NCT01649505|B3|Baseline|Total|Total of all reporting groups
90064|NCT01649505|B2|Baseline|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
90065|NCT01649505|B1|Baseline|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
90066|NCT01649505|P2|Participant Flow|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
90067|NCT01649505|P1|Participant Flow|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
90068|NCT01649505|O2|Outcome|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
90069|NCT01649505|O1|Outcome|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
90070|NCT01649505|E2|Reported Event|Arm II (Standard Electrocoagulation)|Patients undergo standard electrocoagulation dissection technique.
90071|NCT01649505|E1|Reported Event|Arm I (Fibrin Sealant)|Patients undergo sharp dissection technique with fibrin sealant closure.
90072|NCT01649362|B3|Baseline|Total|Total of all reporting groups
90073|NCT01649362|B2|Baseline|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90074|NCT01649362|B1|Baseline|Control Group|no prefeeding oral stimulation
90075|NCT01649362|P2|Participant Flow|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90076|NCT01649362|P1|Participant Flow|Control Group|no prefeeding oral stimulation
90077|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90078|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
90079|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90080|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
90081|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90082|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
90083|NCT01649362|E2|Reported Event|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
90084|NCT01649362|E1|Reported Event|Control Group|no prefeeding oral stimulation
90085|NCT01649297|B6|Baseline|Total|Total of all reporting groups
90086|NCT01649297|B5|Baseline|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
90087|NCT01649297|B4|Baseline|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
90088|NCT01649297|B3|Baseline|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
90089|NCT01649297|B2|Baseline|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
90090|NCT01649297|B1|Baseline|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
90091|NCT01649297|P5|Participant Flow|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
90092|NCT01649297|P4|Participant Flow|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
90093|NCT01649297|P3|Participant Flow|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
90094|NCT01649297|P2|Participant Flow|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
90095|NCT01649297|P1|Participant Flow|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
90096|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
90097|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
90098|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
90099|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
90100|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
90101|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
90102|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
90103|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
90104|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
90105|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
90106|NCT01649297|E5|Reported Event|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
90107|NCT01649297|E4|Reported Event|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
90108|NCT01649297|E3|Reported Event|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
90109|NCT01649297|E2|Reported Event|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
90110|NCT01649297|E1|Reported Event|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
90111|NCT01649232|B3|Baseline|Total|Total of all reporting groups
90112|NCT01649232|B2|Baseline|Controls|Healthy people that not receive tDCS
90113|NCT01649232|B1|Baseline|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90114|NCT01649232|P2|Participant Flow|Controls|Healthy people that not receive tDCS
90115|NCT01649232|P1|Participant Flow|Active tDCS|"Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days.~55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe)."
90116|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
90117|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90118|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
90119|NCT01649232|O3|Outcome|Active tDCS at 3 Months|l Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90120|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
90121|NCT01649232|O1|Outcome|Active tDCS Group|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90122|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
90123|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90124|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
90125|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90127|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90128|NCT01649232|O2|Outcome|Controls|Healthy people that not receive tDCS
90129|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90130|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
90131|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90132|NCT01649232|E2|Reported Event|Controls|Healthy people that not receive tDCS
90133|NCT01649232|E1|Reported Event|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
90134|NCT01648920|B1|Baseline|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90135|NCT01648920|P1|Participant Flow|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90136|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90137|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90138|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90139|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90140|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90141|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90142|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90143|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90144|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90145|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90146|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90147|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90148|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90149|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90150|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90151|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90152|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90153|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90154|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90200|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90155|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90156|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90157|NCT01648920|E1|Reported Event|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
90158|NCT01648790|B1|Baseline|All Participants|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
90159|NCT01648790|P5|Participant Flow|Sequence 5|Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
90160|NCT01648790|P4|Participant Flow|Sequence 4|Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast
90161|NCT01648790|P3|Participant Flow|Sequence 3|Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast
90162|NCT01648790|P2|Participant Flow|Sequence 2|Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed
90163|NCT01648790|P1|Participant Flow|Sequence 1|Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast
90164|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
90165|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
90166|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
90167|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
90168|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
90169|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
90170|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
90171|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
90172|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
90173|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
90174|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
90175|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
90176|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
90177|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
90178|NCT01648790|E5|Reported Event|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
90179|NCT01648790|E4|Reported Event|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
90180|NCT01648790|E3|Reported Event|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
90181|NCT01648790|E2|Reported Event|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
90182|NCT01648790|E1|Reported Event|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
90227|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
91004|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90183|NCT01648699|B1|Baseline|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
90184|NCT01648699|P1|Participant Flow|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
90185|NCT01648699|O1|Outcome|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
90186|NCT01648699|O8|Outcome|OROS Hydromorphone (No Dose Indicated)|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
90187|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90188|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90189|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90190|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90191|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90192|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90193|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90194|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90195|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90196|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90197|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90198|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90199|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90201|NCT01648699|O7|Outcome|OROS Hydromorphone 36 mg|OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90202|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90203|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90204|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90205|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90206|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90207|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
90208|NCT01648699|E1|Reported Event|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
90209|NCT01648582|B4|Baseline|Total|Total of all reporting groups
90210|NCT01648582|B3|Baseline|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90211|NCT01648582|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90212|NCT01648582|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90213|NCT01648582|P3|Participant Flow|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90214|NCT01648582|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90215|NCT01648582|P1|Participant Flow|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90216|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90217|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90218|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90219|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90220|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90221|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90222|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90223|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90224|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90225|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90226|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90228|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90229|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90230|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90231|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90232|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90233|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90234|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90235|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90236|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90237|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90238|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90239|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90240|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90241|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90242|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90243|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90244|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90245|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90246|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90247|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90248|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90249|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90250|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90251|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90252|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90253|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90254|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90255|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90256|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90257|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90258|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90259|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90260|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90261|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90262|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90263|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90264|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90265|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90266|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90267|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90268|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90269|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90270|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90271|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90272|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90273|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90274|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
90275|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90276|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90277|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
90278|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90279|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90280|NCT01648582|E3|Reported Event|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
90281|NCT01648582|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90282|NCT01648582|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
90283|NCT01648530|B1|Baseline|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
90284|NCT01648530|P1|Participant Flow|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
90285|NCT01648530|O2|Outcome|Participants With Chronic Migraine|Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
90286|NCT01648530|O1|Outcome|Participants With Episodic Migraine|Participants who returned completed internet survey with Episodic Migraine defined as <15 headache days/month. No intervention was administered in this study.
90287|NCT01648530|O1|Outcome|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
90288|NCT01648530|E1|Reported Event|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
90289|NCT01648491|B1|Baseline|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
90290|NCT01648491|P1|Participant Flow|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
90291|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
90292|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
90406|NCT01647711|B1|Baseline|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90293|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
90294|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
90295|NCT01648491|E1|Reported Event|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
90296|NCT01648452|B1|Baseline|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90297|NCT01648452|P1|Participant Flow|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90298|NCT01648452|O1|Outcome|Untreated Control Eye|
90299|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90300|NCT01648452|O1|Outcome|Untreated Control Eye|
90301|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90302|NCT01648452|O1|Outcome|Untreated Control Eye|
90303|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90304|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90305|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90306|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90307|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90308|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90309|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90310|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90311|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
90312|NCT01648452|E2|Reported Event|NT-501 CNTF-releasing Implant Events > 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed are adverse events reported after the primary outcome endpoint of 6 months post-implantation.
90313|NCT01648452|E1|Reported Event|NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed reflect the primary outcome endpoint of adverse events reported within 6 months post-implantation.
90314|NCT01648101|B4|Baseline|Total|Total of all reporting groups
90315|NCT01648101|B3|Baseline|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90316|NCT01648101|B2|Baseline|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90317|NCT01648101|B1|Baseline|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90407|NCT01647711|P5|Participant Flow|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90413|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90318|NCT01648101|P3|Participant Flow|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90319|NCT01648101|P2|Participant Flow|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90320|NCT01648101|P1|Participant Flow|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90321|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90322|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90323|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90324|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90325|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90326|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90408|NCT01647711|P4|Participant Flow|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90327|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90328|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90329|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90330|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90331|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90332|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90333|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90334|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90335|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90409|NCT01647711|P3|Participant Flow|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90336|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90337|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90338|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90339|NCT01648101|O4|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90340|NCT01648101|O3|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90341|NCT01648101|O2|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90342|NCT01648101|O1|Outcome|Overall Study Arm|
90343|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90344|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90345|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90410|NCT01647711|P2|Participant Flow|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90346|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90347|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90348|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90349|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90350|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90351|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90352|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90353|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90354|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90411|NCT01647711|P1|Participant Flow|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90355|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90356|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90357|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90358|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90359|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90360|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90361|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90362|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90363|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90412|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90459|NCT01647464|O1|Outcome|Contrast Administration|Patients undergoing contrast-enhanced echo.
90364|NCT01648101|E3|Reported Event|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90365|NCT01648101|E2|Reported Event|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90366|NCT01648101|E1|Reported Event|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
90367|NCT01647945|B5|Baseline|Total|Total of all reporting groups
90368|NCT01647945|B4|Baseline|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90369|NCT01647945|B3|Baseline|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90370|NCT01647945|B2|Baseline|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90371|NCT01647945|B1|Baseline|Placebo|Placebo: placebo pill
90372|NCT01647945|P4|Participant Flow|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90373|NCT01647945|P3|Participant Flow|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90374|NCT01647945|P2|Participant Flow|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90375|NCT01647945|P1|Participant Flow|Placebo|Placebo: placebo pill
90376|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90377|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90378|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90379|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
90380|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90381|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90382|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90383|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
90384|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90385|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90386|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90387|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
90388|NCT01647945|E4|Reported Event|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
90389|NCT01647945|E3|Reported Event|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
90390|NCT01647945|E2|Reported Event|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
90391|NCT01647945|E1|Reported Event|Placebo|Placebo: placebo pill
90392|NCT01647737|B3|Baseline|Total|Total of all reporting groups
90393|NCT01647737|B2|Baseline|Placebo|"Xylitol~Green tea lozenge: 4-6 times daily"
90394|NCT01647737|B1|Baseline|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
90395|NCT01647737|P2|Participant Flow|Placebo|Xylitol lozenge 4 - 6 times daily
90396|NCT01647737|P1|Participant Flow|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
90397|NCT01647737|O2|Outcome|Placebo|Xylitol lozenge 4 - 6 times daily
90398|NCT01647737|O1|Outcome|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
90399|NCT01647737|E2|Reported Event|Xylitol|"4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks~Xylitol: 4-6 times daily"
90400|NCT01647737|E1|Reported Event|MighTeaFlow|"4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks~MighTeaFlow: 4-6 times daily"
90401|NCT01647711|B6|Baseline|Total|Total of all reporting groups
90402|NCT01647711|B5|Baseline|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90403|NCT01647711|B4|Baseline|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90404|NCT01647711|B3|Baseline|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90405|NCT01647711|B2|Baseline|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90460|NCT01647464|E1|Reported Event|Contrast Administration|Patients undergoing contrast-enhanced echo.
90414|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90415|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90416|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90417|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90418|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90419|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90420|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90421|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90422|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90423|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90424|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90425|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90426|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90427|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90428|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90429|NCT01647711|E6|Reported Event|All Participants|All treated participants included in the study.
90430|NCT01647711|E5|Reported Event|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90431|NCT01647711|E4|Reported Event|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90432|NCT01647711|E3|Reported Event|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90433|NCT01647711|E2|Reported Event|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90434|NCT01647711|E1|Reported Event|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
90435|NCT01647542|B4|Baseline|Total|Total of all reporting groups
90436|NCT01647542|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90437|NCT01647542|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90438|NCT01647542|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90439|NCT01647542|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90440|NCT01647542|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90441|NCT01647542|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90442|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90443|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90444|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90445|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90446|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90447|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90448|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90449|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90450|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90451|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90452|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90453|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90454|NCT01647542|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
90455|NCT01647542|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
90456|NCT01647542|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
90457|NCT01647464|B1|Baseline|Contrast Administration|Patients undergoing contrast-enhanced echo.
90458|NCT01647464|P1|Participant Flow|Contrast Administration|Patients undergoing contrast-enhanced echo.
90462|NCT01647438|B2|Baseline|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
90463|NCT01647438|B1|Baseline|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
90464|NCT01647438|P2|Participant Flow|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
90465|NCT01647438|P1|Participant Flow|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
90466|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
90467|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
90468|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
90469|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
90470|NCT01647438|E2|Reported Event|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
90471|NCT01647438|E1|Reported Event|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
90472|NCT01646827|B3|Baseline|Total|Total of all reporting groups
90473|NCT01646827|B2|Baseline|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90474|NCT01646827|B1|Baseline|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90475|NCT01646827|P2|Participant Flow|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90476|NCT01646827|P1|Participant Flow|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90477|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90478|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90479|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90480|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90481|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90482|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90483|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90484|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
91005|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90485|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90486|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90487|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90488|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90489|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90490|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90491|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90492|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90493|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90494|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90495|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90496|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90497|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90498|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90499|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90500|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90501|NCT01646827|E2|Reported Event|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
90502|NCT01646827|E1|Reported Event|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
90503|NCT01646814|B3|Baseline|Total|Total of all reporting groups
90504|NCT01646814|B2|Baseline|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
90505|NCT01646814|B1|Baseline|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
90506|NCT01646814|P2|Participant Flow|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
90507|NCT01646814|P1|Participant Flow|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
90508|NCT01646814|O2|Outcome|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
90509|NCT01646814|O1|Outcome|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
90510|NCT01646814|E2|Reported Event|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
90511|NCT01646814|E1|Reported Event|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
90512|NCT01646671|B4|Baseline|Total|Total of all reporting groups
90513|NCT01646671|B3|Baseline|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90514|NCT01646671|B2|Baseline|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90515|NCT01646671|B1|Baseline|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90516|NCT01646671|P3|Participant Flow|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90517|NCT01646671|P2|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90518|NCT01646671|P1|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90519|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90520|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90521|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90522|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90523|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90524|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90525|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90526|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90527|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90528|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90529|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90530|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90531|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90532|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90533|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90534|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90535|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90536|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90537|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90538|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90539|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90540|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90541|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90542|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90543|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
90544|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
90545|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
90546|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
90547|NCT01646671|E4|Reported Event|Total Participants|All participants who were treated
90548|NCT01646671|E3|Reported Event|LCZ 400 mg + Other HTN Medications|LCZ 400 mg + other HTN medications
90549|NCT01646671|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
90550|NCT01646671|E1|Reported Event|LCZ 200 mg|LCZ 200 mg
90551|NCT01646398|B3|Baseline|Total|Total of all reporting groups
90552|NCT01646398|B2|Baseline|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90553|NCT01646398|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90554|NCT01646398|P2|Participant Flow|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90555|NCT01646398|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90556|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90557|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90558|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90559|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90560|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90561|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90562|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90563|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90564|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90565|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90566|NCT01646398|E2|Reported Event|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
90567|NCT01646398|E1|Reported Event|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
90568|NCT01646385|B3|Baseline|Total|Total of all reporting groups
90844|NCT01645709|P2|Participant Flow|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90569|NCT01646385|B2|Baseline|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90570|NCT01646385|B1|Baseline|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90571|NCT01646385|P2|Participant Flow|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90572|NCT01646385|P1|Participant Flow|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90573|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90574|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90575|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90576|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90577|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90578|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90579|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90580|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90581|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90582|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90625|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90583|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90584|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90585|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90586|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90587|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90588|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90589|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90590|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90591|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90592|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90593|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90594|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90595|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90596|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90626|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90597|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90598|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90599|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90600|NCT01646385|E2|Reported Event|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
90601|NCT01646385|E1|Reported Event|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
90602|NCT01646320|B3|Baseline|Total|Total of all reporting groups
90603|NCT01646320|B2|Baseline|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90604|NCT01646320|B1|Baseline|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90605|NCT01646320|P2|Participant Flow|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90606|NCT01646320|P1|Participant Flow|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90607|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90608|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90609|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90610|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90611|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90612|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90613|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90614|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90615|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90616|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90617|NCT01646320|E2|Reported Event|PLA + SAXA + MET|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90618|NCT01646320|E1|Reported Event|DAPA + SAXA + MET|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
90619|NCT01646268|B3|Baseline|Total|Total of all reporting groups
90620|NCT01646268|B2|Baseline|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90621|NCT01646268|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90622|NCT01646268|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90623|NCT01646268|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90624|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90627|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90628|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90629|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90630|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90631|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90632|NCT01646268|E2|Reported Event|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
90633|NCT01646268|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
90634|NCT01646255|B3|Baseline|Total Title|
90635|NCT01646255|B2|Baseline|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
90636|NCT01646255|B1|Baseline|Placebo|Subjects randomized to placebo received matching placebo patches.
90637|NCT01646255|P2|Participant Flow|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
90638|NCT01646255|P1|Participant Flow|Placebo|Subjects randomized to placebo received matching placebo patches.
90639|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90640|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90641|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90642|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90643|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90644|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90645|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90646|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90647|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90648|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90649|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90650|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90651|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90652|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90653|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90654|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90795|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90655|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90656|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90657|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90658|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90659|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90660|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90661|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
90662|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90663|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
90664|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
90665|NCT01646255|E2|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group~Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week."
90666|NCT01646255|E1|Reported Event|Placebo|"Placebo, daily doses, placebo Group~Subjects randomized to placebo will receive matching placebo patches."
90667|NCT01646177|B5|Baseline|Total|Total of all reporting groups
90668|NCT01646177|B4|Baseline|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90669|NCT01646177|B3|Baseline|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8).~Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90670|NCT01646177|B2|Baseline|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90671|NCT01646177|B1|Baseline|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
90672|NCT01646177|P4|Participant Flow|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90673|NCT01646177|P3|Participant Flow|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90674|NCT01646177|P2|Participant Flow|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
90675|NCT01646177|P1|Participant Flow|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90676|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90677|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90678|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90679|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90680|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90796|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90681|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90682|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90683|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90684|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90685|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90686|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90687|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90688|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90689|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90690|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90691|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90692|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90693|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90694|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90695|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90696|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90697|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90698|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90699|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90700|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90701|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90702|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90703|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90704|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90705|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90706|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90707|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90708|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90709|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90710|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90711|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90712|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90713|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90714|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90715|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90716|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90717|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90718|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90719|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90720|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90721|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90722|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90723|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90724|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90725|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90726|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90727|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90728|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90729|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90730|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90731|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90732|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90733|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90734|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90735|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90736|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90737|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90738|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90739|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90740|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90741|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90742|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90743|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90744|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
90745|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
90746|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
90747|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
90748|NCT01646177|E4|Reported Event|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection Q2W until Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~80 mg ixekizumab: Administered SC"
90749|NCT01646177|E3|Reported Event|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q4W until Week 264.~80 mg ixekizumab: Administered SC"
90750|NCT01646177|E2|Reported Event|50 mg Etanercept|"Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.~50 mg etanercept: Administered SC"
90751|NCT01646177|E1|Reported Event|Placebo|"Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12.~Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~Placebo: Administered SC"
90752|NCT01646151|B1|Baseline|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90753|NCT01646151|P1|Participant Flow|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90754|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90755|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90756|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90757|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90758|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90759|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90760|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90761|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90762|NCT01646151|E1|Reported Event|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
90763|NCT01646138|B6|Baseline|Total|Total of all reporting groups
90764|NCT01646138|B5|Baseline|10^7 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
90765|NCT01646138|B4|Baseline|10^6 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
90766|NCT01646138|B3|Baseline|10^5 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
90767|NCT01646138|B2|Baseline|10^4 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
90768|NCT01646138|B1|Baseline|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
90769|NCT01646138|P5|Participant Flow|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
90770|NCT01646138|P4|Participant Flow|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
90771|NCT01646138|P3|Participant Flow|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
90772|NCT01646138|P2|Participant Flow|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
90773|NCT01646138|P1|Participant Flow|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
90774|NCT01646138|O5|Outcome|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
90775|NCT01646138|O4|Outcome|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
90776|NCT01646138|O3|Outcome|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
90777|NCT01646138|O2|Outcome|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
90778|NCT01646138|O1|Outcome|10^3 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
90779|NCT01646138|E5|Reported Event|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
90780|NCT01646138|E4|Reported Event|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
90781|NCT01646138|E3|Reported Event|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
90782|NCT01646138|E2|Reported Event|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
90783|NCT01646138|E1|Reported Event|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
90784|NCT01646073|B3|Baseline|Total|Total of all reporting groups
90785|NCT01646073|B2|Baseline|Adalimumab Eow|Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
90786|NCT01646073|B1|Baseline|Placebo|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B
90787|NCT01646073|P2|Participant Flow|Adalimumab Eow|Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
90788|NCT01646073|P1|Participant Flow|Placebo|Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B
90789|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90790|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90791|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90792|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90793|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90794|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90997|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90797|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90798|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90799|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90800|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90801|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90802|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90803|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90804|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90805|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90806|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90807|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90808|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90809|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90810|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90811|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90812|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90813|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90814|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90815|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90816|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90817|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90818|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
90819|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90820|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90821|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
90822|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
90823|NCT01646073|E3|Reported Event|Any Adalimumab|Participants that received at least one dose of adalimumab during Period A or Period B
90824|NCT01646073|E2|Reported Event|Double-blind Adalimumab Eow|Participants were started on adalimumab eow in Period A (Week 0 to Week 12)
90825|NCT01646073|E1|Reported Event|Double-blind Placebo|Participants were started on placebo in Period A (Week 0 to Week 12)
90826|NCT01645735|B3|Baseline|Total|Total of all reporting groups
90827|NCT01645735|B2|Baseline|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90828|NCT01645735|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90829|NCT01645735|P2|Participant Flow|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
90830|NCT01645735|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
90831|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90832|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90833|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90834|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90835|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV q24 plus vancomycin 15mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90836|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90837|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90838|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90839|NCT01645735|E2|Reported Event|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
90840|NCT01645735|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
90841|NCT01645709|B3|Baseline|Total|Total of all reporting groups
90842|NCT01645709|B2|Baseline|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90843|NCT01645709|B1|Baseline|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90845|NCT01645709|P1|Participant Flow|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90846|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90847|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90848|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90849|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90850|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90851|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90852|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90853|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90854|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90855|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90856|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90857|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90858|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90859|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90860|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90861|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90862|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90863|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90864|NCT01645709|E2|Reported Event|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
90865|NCT01645709|E1|Reported Event|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
90866|NCT01645280|B6|Baseline|Total|Total of all reporting groups
90867|NCT01645280|B5|Baseline|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90868|NCT01645280|B4|Baseline|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90869|NCT01645280|B3|Baseline|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90870|NCT01645280|B2|Baseline|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90871|NCT01645280|B1|Baseline|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90872|NCT01645280|P5|Participant Flow|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90873|NCT01645280|P4|Participant Flow|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90874|NCT01645280|P3|Participant Flow|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90875|NCT01645280|P2|Participant Flow|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90876|NCT01645280|P1|Participant Flow|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90877|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90878|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90879|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90880|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90881|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90998|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90882|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90883|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90884|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90885|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90886|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90887|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90888|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90889|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90890|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90891|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90892|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90893|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90894|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90895|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90896|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90897|NCT01645280|E6|Reported Event|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90898|NCT01645280|E5|Reported Event|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90899|NCT01645280|E4|Reported Event|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
90900|NCT01645280|E3|Reported Event|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
90901|NCT01645280|E2|Reported Event|Placebo (Early Escape)|Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
90902|NCT01645280|E1|Reported Event|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
90903|NCT01645111|B1|Baseline|Clevidipine|Clevidipine
90904|NCT01645111|P1|Participant Flow|Clevidipine|Clevidipine
90905|NCT01645111|O1|Outcome|Clevidipine|Clevidipine
90906|NCT01645111|E1|Reported Event|Clevidipine|Clevidipine
90907|NCT01645098|B3|Baseline|Total|Total of all reporting groups
90908|NCT01645098|B2|Baseline|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90909|NCT01645098|B1|Baseline|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90910|NCT01645098|P2|Participant Flow|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90911|NCT01645098|P1|Participant Flow|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90912|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90913|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90914|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
92408|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
90915|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90916|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90917|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90918|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90919|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90920|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90921|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90922|NCT01645098|E2|Reported Event|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90923|NCT01645098|E1|Reported Event|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
90924|NCT01645059|B1|Baseline|Disseminated Her 2+ Breast Cancer|
90925|NCT01645059|P1|Participant Flow|Disseminated Her 2+ Breast Cancer|
90926|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
90927|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
90928|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
90929|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
90930|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
90931|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
90932|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
90933|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
90934|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
90935|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
90936|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
90937|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
90938|NCT01645059|O1|Outcome|Disseminated HER 2 + Breast Cancer|
90939|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
90940|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
90941|NCT01645059|E1|Reported Event|Disseminated Her 2+ Breast Cancer|
90942|NCT01644734|B1|Baseline|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
90943|NCT01644734|P1|Participant Flow|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
90944|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
90945|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
90946|NCT01644734|E1|Reported Event|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
90947|NCT01644695|B1|Baseline|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
90948|NCT01644695|P1|Participant Flow|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
90999|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91000|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91001|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91002|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91003|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90949|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
90950|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
90951|NCT01644695|E1|Reported Event|All Participants|No participant was excempt from this measure.
90952|NCT01644643|B5|Baseline|Total|Total of all reporting groups
90953|NCT01644643|B4|Baseline|cUTI:CAZ-AVI|cUTI: CAZ-AVI
90954|NCT01644643|B3|Baseline|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90955|NCT01644643|B2|Baseline|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90956|NCT01644643|B1|Baseline|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90957|NCT01644643|P4|Participant Flow|cUTI:CAZ-AVI|cUTI: CAZ-AVI
90958|NCT01644643|P3|Participant Flow|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90959|NCT01644643|P2|Participant Flow|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90960|NCT01644643|P1|Participant Flow|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90961|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
90962|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
90963|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
90964|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
90965|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
90966|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
90967|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
90968|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
90969|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
90970|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
90971|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
90972|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
90973|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90974|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90975|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90976|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90977|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90978|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90979|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90980|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90981|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90982|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90983|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90984|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90985|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90986|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90987|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90988|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90989|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90990|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90991|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90992|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
90993|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
90994|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
90995|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
90996|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91006|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91007|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91008|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91009|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91010|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91011|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91012|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91013|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91014|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91015|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91016|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91017|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91018|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91019|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91020|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91021|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91022|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91023|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91024|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91025|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91026|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91027|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91028|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91029|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91030|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91031|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91032|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91033|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91034|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91035|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91036|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91037|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91038|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91039|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91040|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91041|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91042|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91043|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91044|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91045|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91046|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91047|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91048|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91049|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91050|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91051|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91052|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91053|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91054|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91055|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91056|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91057|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91058|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91059|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91060|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91061|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
92454|NCT01640184|B4|Baseline|Total|Total of all reporting groups
91062|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91063|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91064|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91065|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91066|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91067|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91068|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91069|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91070|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91071|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91072|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91073|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91074|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91075|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91076|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91077|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91078|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91079|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91080|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91081|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91082|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91083|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91084|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91085|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91086|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91087|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91088|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91089|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91090|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91091|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91092|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91093|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91094|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91095|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91096|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91097|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91098|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91099|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91100|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91101|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91102|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91103|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91104|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91105|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91106|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91107|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91108|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91109|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91110|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91111|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91112|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91113|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
91114|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91115|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91116|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91117|NCT01644643|E4|Reported Event|cUTI:CAZ-AVI|cUTI: CAZ-AVI
92637|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
91118|NCT01644643|E3|Reported Event|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
91119|NCT01644643|E2|Reported Event|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
91120|NCT01644643|E1|Reported Event|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
91121|NCT01644617|B4|Baseline|Total|Total of all reporting groups
91122|NCT01644617|B3|Baseline|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91123|NCT01644617|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91124|NCT01644617|B1|Baseline|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91125|NCT01644617|P3|Participant Flow|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91126|NCT01644617|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91127|NCT01644617|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91128|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91129|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91130|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91131|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91132|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91133|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91134|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91135|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91136|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91137|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91138|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91139|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91140|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91141|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91142|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91143|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91144|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91145|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91146|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91147|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91148|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91149|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91150|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91151|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91152|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91153|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91154|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91155|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91156|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91157|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91158|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91159|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91160|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91161|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91162|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91163|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91164|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91165|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91166|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91167|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91168|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91169|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91170|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91171|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91172|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91173|NCT01644617|E3|Reported Event|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91174|NCT01644617|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
91175|NCT01644617|E1|Reported Event|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
91176|NCT01644500|B4|Baseline|Total|Total of all reporting groups
91177|NCT01644500|B3|Baseline|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91178|NCT01644500|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91179|NCT01644500|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91180|NCT01644500|P3|Participant Flow|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91181|NCT01644500|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91182|NCT01644500|P1|Participant Flow|1.5 mg Dulaglutide|1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91183|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91184|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91185|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91186|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91187|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91188|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91189|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
92638|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
91190|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91191|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91192|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91193|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91194|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91195|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91196|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91197|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91198|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91199|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91200|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91201|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91202|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91203|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91204|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91205|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91206|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91207|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91208|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91209|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91210|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91211|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91212|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91213|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91214|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91215|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91216|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91217|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91218|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91219|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91220|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91221|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91222|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91223|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91224|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91225|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91226|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91227|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91228|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91229|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91230|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91231|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91232|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91233|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91234|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91235|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91236|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91237|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91238|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91239|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91240|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91241|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91242|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91243|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91244|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91245|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91246|NCT01644500|E3|Reported Event|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
91247|NCT01644500|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91248|NCT01644500|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
91249|NCT01644474|B3|Baseline|Total|Total of all reporting groups
91250|NCT01644474|B2|Baseline|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91251|NCT01644474|B1|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91252|NCT01644474|P2|Participant Flow|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91253|NCT01644474|P1|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
91254|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91255|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91256|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91257|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
92639|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
91258|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91259|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91260|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91261|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91262|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91263|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91264|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91265|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91266|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91267|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91268|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91269|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91270|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91271|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91272|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91273|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91274|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91275|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91276|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91277|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91278|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91279|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91280|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91281|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91282|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91283|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91284|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91285|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91286|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91287|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91288|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91289|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
91290|NCT01644474|E2|Reported Event|Alirocumab 75/Up150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W (mean exposure of 22 weeks).
91291|NCT01644474|E1|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg (mean exposure of 22 weeks).
91292|NCT01644396|B1|Baseline|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
92640|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
91293|NCT01644396|P1|Participant Flow|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91294|NCT01644396|O1|Outcome|Adalimumab|Number of participants with adverse events
91295|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91296|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91297|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91298|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91299|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91300|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91301|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91302|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91303|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91304|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91305|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91306|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91307|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91308|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91309|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91310|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91311|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91312|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91313|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91314|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91315|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91316|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91317|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91318|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91319|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91320|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91321|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91322|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91323|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91385|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91324|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91325|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91326|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91327|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91328|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91329|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91330|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91331|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91332|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91333|NCT01644396|E1|Reported Event|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
91334|NCT01644292|B1|Baseline|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
91335|NCT01644292|P1|Participant Flow|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
91336|NCT01644292|O1|Outcome|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
91337|NCT01644292|E1|Reported Event|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
91338|NCT01644188|B3|Baseline|Total|Total of all reporting groups
91339|NCT01644188|B2|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91340|NCT01644188|B1|Baseline|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91341|NCT01644188|P2|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91342|NCT01644188|P1|Participant Flow|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid­ Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91343|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91344|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91345|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91346|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91347|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91348|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91349|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91350|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91351|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91352|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91353|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91423|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91354|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91355|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91356|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91357|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91358|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91359|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91360|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91361|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91362|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91363|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91364|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91365|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91366|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91367|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91368|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91369|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91370|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91371|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91372|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91373|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91374|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91375|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91376|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91377|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91378|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91379|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91380|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91381|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91382|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91383|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91384|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91386|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91387|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91388|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91389|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91390|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91391|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91392|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91393|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
91394|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
91395|NCT01644188|E2|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks).
91396|NCT01644188|E1|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks).
91397|NCT01644175|B3|Baseline|Total|Total of all reporting groups
91398|NCT01644175|B2|Baseline|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91399|NCT01644175|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91400|NCT01644175|P2|Participant Flow|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91401|NCT01644175|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
91402|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91403|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91404|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91405|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91406|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91407|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91408|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91409|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91410|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91411|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91412|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91413|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91414|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91415|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91416|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91417|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91418|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91419|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91420|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91421|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91422|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91424|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91425|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91426|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91427|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91428|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91429|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91430|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91431|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91432|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91433|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91434|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91435|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91436|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91437|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91438|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91439|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91440|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91441|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91442|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91443|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91444|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91445|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91446|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
91447|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
91448|NCT01644175|E2|Reported Event|Alirocumab 75 /up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
91449|NCT01644175|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks).
91450|NCT01644058|B1|Baseline|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
91451|NCT01644058|P1|Participant Flow|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
91452|NCT01644058|O1|Outcome|Immediate Loading|"Immediate loading of 2 endo-osseous mandibular implants~Immediate loading"
91453|NCT01644058|O1|Outcome|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
91454|NCT01644058|E1|Reported Event|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
91455|NCT01643876|B1|Baseline|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
91456|NCT01643876|P1|Participant Flow|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
91457|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
91458|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
91529|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
92641|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
91459|NCT01643876|E1|Reported Event|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
91460|NCT01643798|B1|Baseline|Pretreatment & Stimulation|Outside of the 3T magnetic resonance imaging (MRI) scanner, participants underwent resting motor threshold assessment, left dorsolateral prefrontal cortex localization and preliminary pain testing. Next, participants were placed in the scanner for baseline pain testing. After baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive approximately 10 ml intravenous naloxone (0.1mg/kg) or saline immediately prior to 20 minutes of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20 minutes of real left DLPFC rTMS. Participants then returned to the scanner for the final block test.
91461|NCT01643798|P2|Participant Flow|Naloxone and Stimulation, Then Saline and Stimulation|Participants received an intravenous infusion of 0.1mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
91462|NCT01643798|P1|Participant Flow|Saline and Stimulation, Then Naloxone and Stimulation|Participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 0.1 mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
91463|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
91464|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
91465|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
91466|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
91467|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
91468|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
91530|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91469|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
91470|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
91471|NCT01643798|E1|Reported Event|Pretreatment & Stimulation|
91472|NCT01643616|B3|Baseline|Total|Total of all reporting groups
91473|NCT01643616|B2|Baseline|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91474|NCT01643616|B1|Baseline|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91475|NCT01643616|P2|Participant Flow|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91476|NCT01643616|P1|Participant Flow|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91477|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91478|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91479|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91480|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91481|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91482|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91483|NCT01643616|E2|Reported Event|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91484|NCT01643616|E1|Reported Event|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
91485|NCT01643525|B1|Baseline|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
91486|NCT01643525|P1|Participant Flow|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
91487|NCT01643525|O1|Outcome|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
91488|NCT01643525|E1|Reported Event|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
91489|NCT01643213|B3|Baseline|Total|Total of all reporting groups
91490|NCT01643213|B2|Baseline|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
91491|NCT01643213|B1|Baseline|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
91492|NCT01643213|P2|Participant Flow|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
91493|NCT01643213|P1|Participant Flow|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
91494|NCT01643213|O2|Outcome|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
91495|NCT01643213|O1|Outcome|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
91496|NCT01643213|E2|Reported Event|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
91497|NCT01643213|E1|Reported Event|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
91498|NCT01643044|B3|Baseline|Total|Total of all reporting groups
91499|NCT01643044|B2|Baseline|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
91500|NCT01643044|B1|Baseline|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
91531|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91854|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91501|NCT01643044|P2|Participant Flow|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
91502|NCT01643044|P1|Participant Flow|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
91503|NCT01643044|O2|Outcome|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
91504|NCT01643044|O1|Outcome|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
91505|NCT01643044|E2|Reported Event|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
91506|NCT01643044|E1|Reported Event|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
91507|NCT01642914|B4|Baseline|Total|Total of all reporting groups
91508|NCT01642914|B3|Baseline|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91509|NCT01642914|B2|Baseline|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91510|NCT01642914|B1|Baseline|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91511|NCT01642914|P3|Participant Flow|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91512|NCT01642914|P2|Participant Flow|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91513|NCT01642914|P1|Participant Flow|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91514|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91515|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91516|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
91517|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91518|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91519|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91520|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91521|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91522|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91523|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91524|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91525|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91526|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91527|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91528|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91532|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91533|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91534|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91535|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91536|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91537|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91538|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91539|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91540|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91541|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91542|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91543|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91544|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91545|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91546|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91547|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91548|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91549|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91550|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91551|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91552|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91553|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91554|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91555|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91556|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91557|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91558|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91559|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91560|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91561|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91562|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91563|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91564|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91565|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91566|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91567|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91568|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91569|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91570|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91571|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91572|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91573|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91574|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91575|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91576|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91577|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91578|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91579|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91580|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91581|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91582|NCT01642914|O2|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91583|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91584|NCT01642914|E3|Reported Event|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91585|NCT01642914|E2|Reported Event|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91586|NCT01642914|E1|Reported Event|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
91587|NCT01642732|B1|Baseline|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
91588|NCT01642732|P1|Participant Flow|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
91589|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
91590|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
91895|NCT01641991|E2|Reported Event|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91591|NCT01642732|E1|Reported Event|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
91592|NCT01642615|B1|Baseline|All Participants|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
91593|NCT01642615|P3|Participant Flow|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
91594|NCT01642615|P2|Participant Flow|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
91595|NCT01642615|P1|Participant Flow|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
91596|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
91597|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
91598|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
91599|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
91600|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
91601|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
91602|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
91603|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
91604|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
91605|NCT01642615|E3|Reported Event|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
91606|NCT01642615|E2|Reported Event|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
91607|NCT01642615|E1|Reported Event|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
91608|NCT01642602|B1|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
91609|NCT01642602|P1|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
91610|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
91611|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
91612|NCT01642602|E1|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
91613|NCT01642589|B3|Baseline|Total|Total of all reporting groups
91614|NCT01642589|B2|Baseline|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91615|NCT01642589|B1|Baseline|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91616|NCT01642589|P2|Participant Flow|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91617|NCT01642589|P1|Participant Flow|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91618|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91619|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91620|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91621|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91622|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91623|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91624|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
92642|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
91625|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91626|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91627|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91628|NCT01642589|E2|Reported Event|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
91629|NCT01642589|E1|Reported Event|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
91630|NCT01642485|B1|Baseline|All Study Participants|Subjects participating in the study attended for screening, two treatment periods (periods 1 and 2) of 4 assessment days each and a follow-up visit. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in fasted condition or with Continental breakfast, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. No wash-out was required between the other treatments investigated. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
91631|NCT01642485|P8|Participant Flow|Sequence 8|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fasted"
91632|NCT01642485|P7|Participant Flow|Sequence 7|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fasted"
91633|NCT01642485|P6|Participant Flow|Sequence 6|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fasted"
91634|NCT01642485|P5|Participant Flow|Sequence 5|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fasted"
91635|NCT01642485|P4|Participant Flow|Sequence 4|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
91636|NCT01642485|P3|Participant Flow|Sequence 3|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
91637|NCT01642485|P2|Participant Flow|Sequence 2|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
91638|NCT01642485|P1|Participant Flow|Sequence 1|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
91639|NCT01642485|O4|Outcome|Japanese Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
91640|NCT01642485|O3|Outcome|Japanese Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
91641|NCT01642485|O2|Outcome|Caucasian Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
91642|NCT01642485|O1|Outcome|Caucasian Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (1h)
91643|NCT01642485|O3|Outcome|C-peptide|A euglycaemic/hyperinsulinaemic clamp involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous glucose and insulin production, and as a result reducing the release of C-peptides. This technique will firstly test whether hyperinsulinaemia has an effect on QT interval, and secondly whether C-peptide levels play any role in the proposed effect on the QT interval.
91644|NCT01642485|O2|Outcome|Glucose|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
91645|NCT01642485|O1|Outcome|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
91646|NCT01642485|O2|Outcome|Placebo|Time matched absolute value for QTcF for placebo treatment.
91647|NCT01642485|O1|Outcome|Moxifloxacin 400 mg Fasted|The highest change was at 2.5h time point, which is presented here.
91648|NCT01642485|O3|Outcome|Placebo at Baseline|a baseline QTcF measured on Day -1 of each period
91649|NCT01642485|O2|Outcome|Continental Breakfast|"Continental breakfast: High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.~QTcF change from a baseline presented."
91896|NCT01641991|E1|Reported Event|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91650|NCT01642485|O1|Outcome|FDA Breakfast|FDA breakfast: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
91651|NCT01642485|O2|Outcome|Fed Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fed conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
91652|NCT01642485|O1|Outcome|Fasted Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fasted conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
91653|NCT01642485|E2|Reported Event|Moxifloxacin 400 mg Fed|"Moxifloxacin with food: Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.~No significant other Adverse Events have been reported."
91654|NCT01642485|E1|Reported Event|Moxifloxacin 400 mg Fasted|"Moxifloxacin fasted: One single dose of 400mg moxifloxacin after fasting - This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.~No significant other Adverse Events have been reported."
91655|NCT01642277|B3|Baseline|Total|Total of all reporting groups
91656|NCT01642277|B2|Baseline|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
91657|NCT01642277|B1|Baseline|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
91658|NCT01642277|P2|Participant Flow|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
91659|NCT01642277|P1|Participant Flow|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
91660|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
91661|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
91662|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
91663|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
91664|NCT01642277|O1|Outcome|Urinary Urge Incontinence|Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
91665|NCT01642277|E2|Reported Event|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
91666|NCT01642277|E1|Reported Event|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
91667|NCT01642238|B1|Baseline|Antithrombotic Effects|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
91668|NCT01642238|P2|Participant Flow|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
91669|NCT01642238|P1|Participant Flow|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
91670|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91671|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91687|NCT01642238|E1|Reported Event|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
91688|NCT01642212|B3|Baseline|Total|Total of all reporting groups
91672|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91673|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91674|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91675|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91676|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91677|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91678|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91679|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91680|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91681|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91682|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91683|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91684|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91685|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
91686|NCT01642238|E2|Reported Event|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
91711|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91689|NCT01642212|B2|Baseline|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91690|NCT01642212|B1|Baseline|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91691|NCT01642212|P5|Participant Flow|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
91692|NCT01642212|P4|Participant Flow|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
91693|NCT01642212|P3|Participant Flow|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91694|NCT01642212|P2|Participant Flow|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91695|NCT01642212|P1|Participant Flow|Single-blind Placebo|Eligible participants entered a 4-week, single-blind, placebo baseline period. Participants ingested the first dose of placebo in the clinic in the presence of study center personnel, and the remaining doses were ingested at home. Participants took placebo twice daily (bid); once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91696|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91697|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91698|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91699|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91700|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91701|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91702|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91703|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91704|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91705|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91706|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91707|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91708|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91709|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91710|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91853|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91712|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91713|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91714|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91715|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91716|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91717|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91718|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91719|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91720|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91721|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91722|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91723|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91724|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91725|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91726|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91727|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91728|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91729|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91730|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91731|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91732|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91733|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91734|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91735|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91736|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91897|NCT01641978|B1|Baseline|Neurologic Level|Neurologic patients
91737|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91738|NCT01642212|E4|Reported Event|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
91739|NCT01642212|E3|Reported Event|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
91740|NCT01642212|E2|Reported Event|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2mg OBS (formulation MB-9) 2 mg twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91741|NCT01642212|E1|Reported Event|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
91742|NCT01642147|B3|Baseline|Total|Total of all reporting groups
91743|NCT01642147|B2|Baseline|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91744|NCT01642147|B1|Baseline|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91745|NCT01642147|P2|Participant Flow|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91746|NCT01642147|P1|Participant Flow|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91747|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91748|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91749|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91750|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91751|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91752|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91753|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91754|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91755|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91756|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91757|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91758|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91759|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91812|NCT01642004|E2|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91760|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91761|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91762|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91763|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91764|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91765|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91766|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91767|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91768|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91769|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91770|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
91771|NCT01642147|E2|Reported Event|Craniotomy Group|Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.
91772|NCT01642147|E1|Reported Event|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
91773|NCT01642082|B1|Baseline|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
91774|NCT01642082|P1|Participant Flow|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91775|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91776|NCT01642082|O1|Outcome|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
91777|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91778|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91779|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91780|NCT01642082|E1|Reported Event|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
91781|NCT01642004|B3|Baseline|Total|Total of all reporting groups
91782|NCT01642004|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91783|NCT01642004|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91784|NCT01642004|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91785|NCT01642004|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91786|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91787|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91788|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91789|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91790|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91791|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91792|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91793|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91794|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91795|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91796|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91797|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91798|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91799|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91800|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91801|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91802|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91803|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91804|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91805|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91806|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91807|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91808|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91809|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91810|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91811|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91813|NCT01642004|E1|Reported Event|NIVOLUMAB|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
91814|NCT01641991|B5|Baseline|Total|Total of all reporting groups
91815|NCT01641991|B4|Baseline|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91816|NCT01641991|B3|Baseline|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91817|NCT01641991|B2|Baseline|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91818|NCT01641991|B1|Baseline|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91819|NCT01641991|P4|Participant Flow|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91820|NCT01641991|P3|Participant Flow|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91821|NCT01641991|P2|Participant Flow|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91822|NCT01641991|P1|Participant Flow|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91823|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91824|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91825|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91826|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91827|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91828|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91829|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91830|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91831|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91832|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91833|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91834|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91835|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91836|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91837|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91838|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91839|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91840|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91841|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91842|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91843|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91844|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91845|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91846|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91847|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91848|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91849|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91850|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91851|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91852|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91898|NCT01641978|P1|Participant Flow|Neurologic Level|Neurologic patients
91855|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91856|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91857|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91858|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91859|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91860|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91861|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91862|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91863|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91864|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91865|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91866|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91867|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91868|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91869|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91870|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91871|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91872|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91873|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91874|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91875|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91876|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91877|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91878|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91879|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91880|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91881|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91882|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91883|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91884|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91885|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91886|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91887|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91888|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91889|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91890|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91891|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91892|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
91893|NCT01641991|E4|Reported Event|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
91894|NCT01641991|E3|Reported Event|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
92012|NCT01641835|B1|Baseline|Normals|No eye disease.
91899|NCT01641978|O1|Outcome|Critical Care Time Experience|Influence of work experience in the evaluation of neurological patients
91900|NCT01641978|O3|Outcome|Slight|patients with GCS > 12 points
91901|NCT01641978|O2|Outcome|Moderate|patients with GCS 9 - 12 points
91902|NCT01641978|O1|Outcome|Severe|patients with GCS < 9 points
91903|NCT01641978|O1|Outcome|Neurologic Level|Neurologic patients
91904|NCT01641978|E1|Reported Event|Neurologic Level|Neurologic patients
91905|NCT01641952|B1|Baseline|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91906|NCT01641952|P1|Participant Flow|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91907|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91908|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91909|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91910|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91911|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91912|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91913|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91914|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91915|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91916|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91917|NCT01641952|E1|Reported Event|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
91918|NCT01641939|B4|Baseline|Total|Total of all reporting groups
91919|NCT01641939|B3|Baseline|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91920|NCT01641939|B2|Baseline|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91921|NCT01641939|B1|Baseline|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91922|NCT01641939|P3|Participant Flow|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91923|NCT01641939|P2|Participant Flow|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91924|NCT01641939|P1|Participant Flow|Standard Taxane Therapy|Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91925|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91926|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
92013|NCT01641835|P1|Participant Flow|Normals|No eye disease.
91927|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91928|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91929|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91930|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91931|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91932|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91933|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91934|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91935|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91936|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91937|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91938|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91939|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91940|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91941|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91942|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91943|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91944|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91945|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91946|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91947|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91948|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
92404|NCT01640327|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
91949|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91950|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91951|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91952|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91953|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91954|NCT01641939|O3|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91955|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91956|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91957|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91958|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91959|NCT01641939|E3|Reported Event|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91960|NCT01641939|E2|Reported Event|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91961|NCT01641939|E1|Reported Event|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
91962|NCT01641926|B5|Baseline|Total|Total of all reporting groups
91963|NCT01641926|B4|Baseline|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91964|NCT01641926|B3|Baseline|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91965|NCT01641926|B2|Baseline|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91966|NCT01641926|B1|Baseline|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91967|NCT01641926|P4|Participant Flow|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91968|NCT01641926|P3|Participant Flow|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91969|NCT01641926|P2|Participant Flow|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91970|NCT01641926|P1|Participant Flow|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91971|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91972|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91973|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91974|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91975|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91976|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91977|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91978|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91979|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
92643|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
91980|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91981|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91982|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91983|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91984|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91985|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91986|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91987|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91988|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91989|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91990|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91991|NCT01641926|E4|Reported Event|HBeAG(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91992|NCT01641926|E3|Reported Event|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
91993|NCT01641926|E2|Reported Event|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
91994|NCT01641926|E1|Reported Event|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
91995|NCT01641861|B3|Baseline|Total|Total of all reporting groups
91996|NCT01641861|B2|Baseline|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
91997|NCT01641861|B1|Baseline|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
91998|NCT01641861|P2|Participant Flow|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
91999|NCT01641861|P1|Participant Flow|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92000|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92001|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92002|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92003|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92004|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92005|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92006|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92007|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92008|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92009|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92010|NCT01641861|E2|Reported Event|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
92011|NCT01641861|E1|Reported Event|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
92014|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
92015|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
92016|NCT01641835|E1|Reported Event|Normals|No adverse events were reported.
92017|NCT01641822|B3|Baseline|Total|Total of all reporting groups
92018|NCT01641822|B2|Baseline|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92019|NCT01641822|B1|Baseline|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92020|NCT01641822|P3|Participant Flow|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92021|NCT01641822|P2|Participant Flow|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92022|NCT01641822|P1|Participant Flow|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
92023|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92024|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92025|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92026|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92027|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92028|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92029|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92030|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92031|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92032|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92033|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92034|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92035|NCT01641822|E3|Reported Event|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92036|NCT01641822|E2|Reported Event|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
92037|NCT01641822|E1|Reported Event|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
92038|NCT01641692|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments :~UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo."
92039|NCT01641692|P8|Participant Flow|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92040|NCT01641692|P7|Participant Flow|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92041|NCT01641692|P6|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92042|NCT01641692|P5|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92043|NCT01641692|P4|Participant Flow|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92044|NCT01641692|P3|Participant Flow|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92045|NCT01641692|P2|Participant Flow|UMEC 15.6 µg QD|Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92046|NCT01641692|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
92644|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92047|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92048|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92049|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92050|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92051|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92052|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92053|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92054|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92055|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92056|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92057|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92058|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92059|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92060|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92061|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92062|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92063|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92064|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92065|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92066|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92067|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92068|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92069|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92070|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92071|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92072|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92073|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92074|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92075|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92076|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92077|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92078|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92079|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92080|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92081|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92082|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92083|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92084|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92085|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92086|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92087|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92088|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92089|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92090|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92091|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92092|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92093|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92094|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92095|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92096|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92097|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92098|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92099|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92100|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92101|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92102|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92103|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92104|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92105|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92106|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92107|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92108|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92109|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92110|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92111|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92112|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92113|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92114|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92115|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92116|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92117|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92118|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92119|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92120|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92121|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92122|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92123|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92124|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92125|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92126|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92127|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92128|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92129|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92130|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92131|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92132|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92133|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92134|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92135|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92136|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92137|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92138|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92139|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92140|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92141|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92142|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92143|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92144|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92145|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92146|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92147|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92148|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92149|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92150|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92151|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92152|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92153|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92154|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92155|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92156|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92157|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92158|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92159|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92160|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92161|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92162|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92163|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92164|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92165|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92166|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92167|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92168|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92169|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92170|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92171|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92172|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92173|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92174|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92175|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92176|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92177|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92178|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92179|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92180|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92181|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92182|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92183|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92184|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92185|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92186|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92187|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92188|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92189|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92190|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92191|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92192|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92193|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92194|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92195|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92196|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92197|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92198|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92199|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92200|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92201|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92202|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92203|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92204|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92205|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92206|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92207|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92208|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92209|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92210|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92211|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92212|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92213|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92214|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92215|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92216|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92217|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92218|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92219|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92220|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92221|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92222|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92223|NCT01641692|O1|Outcome|All Study Treatments|The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo.
92224|NCT01641692|E8|Reported Event|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92225|NCT01641692|E7|Reported Event|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
92226|NCT01641692|E6|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92227|NCT01641692|E5|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92228|NCT01641692|E4|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92229|NCT01641692|E3|Reported Event|UMEC 31.5 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92230|NCT01641692|E2|Reported Event|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
92231|NCT01641692|E1|Reported Event|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
92232|NCT01641653|B3|Baseline|Total|Total of all reporting groups
92233|NCT01641653|B2|Baseline|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
92234|NCT01641653|B1|Baseline|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
92235|NCT01641653|P2|Participant Flow|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
92236|NCT01641653|P1|Participant Flow|Placebo|"half of the patients will receive placebo (normal saline 2mL) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
92237|NCT01641653|O2|Outcome|Midazolam|subjects will receive midazolam 1.5-2mg prior to entering the OR
92238|NCT01641653|O1|Outcome|Placebo|subjects will receive 2cc. Normal Saline prior to entering the OR
92239|NCT01641653|O2|Outcome|Midazolam|half of subjects will receive Midazolam: 1-2.5 mgIV prior to entering the OR
92240|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
92241|NCT01641653|O2|Outcome|Midazolam|One half of subjects will recieveMidazolam: 1-2.5 mg IV
92242|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
92243|NCT01641653|E2|Reported Event|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
92244|NCT01641653|E1|Reported Event|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
92245|NCT01641640|B1|Baseline|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92246|NCT01641640|P1|Participant Flow|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92247|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92248|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92249|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92250|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92251|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92252|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92253|NCT01641640|E1|Reported Event|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
92254|NCT01641471|B3|Baseline|Total|Total of all reporting groups
92281|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92282|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92405|NCT01640327|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92255|NCT01641471|B2|Baseline|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
92256|NCT01641471|B1|Baseline|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
92257|NCT01641471|P2|Participant Flow|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
92258|NCT01641471|P1|Participant Flow|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
92259|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
92260|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
92261|NCT01641471|E2|Reported Event|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
92283|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92284|NCT01641237|E4|Reported Event|Placebo Dentifrice (0 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
92406|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
92262|NCT01641471|E1|Reported Event|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
92263|NCT01641237|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments.
92264|NCT01641237|P4|Participant Flow|Placebo Dentifrice (0ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92265|NCT01641237|P3|Participant Flow|NaF Dentifrice (250ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92266|NCT01641237|P2|Participant Flow|NaF Dentifrice (1150ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92267|NCT01641237|P1|Participant Flow|Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92268|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92269|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92270|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92271|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92272|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92273|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92274|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92275|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92276|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92277|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92278|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92279|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92280|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
92285|NCT01641237|E3|Reported Event|NaF Dentifrice (250 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.
92286|NCT01641237|E2|Reported Event|NaF Dentifrice (1150 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.
92287|NCT01641237|E1|Reported Event|NaF Dentifrice (1426 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.
92288|NCT01641159|B3|Baseline|Total|Total of all reporting groups
92289|NCT01641159|B2|Baseline|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
92290|NCT01641159|B1|Baseline|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
92291|NCT01641159|P2|Participant Flow|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
92292|NCT01641159|P1|Participant Flow|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
92293|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
92294|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
92295|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
92296|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
92297|NCT01641159|E2|Reported Event|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
92298|NCT01641159|E1|Reported Event|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
92299|NCT01641120|B1|Baseline|All Study Participants|Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
92300|NCT01641120|P1|Participant Flow|25 Gauge or 30 Gauge Needle|Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
92301|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
92302|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
92303|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
92304|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
92305|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
92306|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
92307|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
92308|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
92309|NCT01641120|E2|Reported Event|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
92310|NCT01641120|E1|Reported Event|25 Gauge|The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
92311|NCT01641081|B1|Baseline|Overall Study Population|All patients participating in the crossover study
92312|NCT01641081|P10|Participant Flow|Sequence 10|Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
92313|NCT01641081|P9|Participant Flow|Sequence 9|12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
92314|NCT01641081|P8|Participant Flow|Sequence 8|24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
92407|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92315|NCT01641081|P7|Participant Flow|Sequence 7|Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
92316|NCT01641081|P6|Participant Flow|Sequence 6|Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
92317|NCT01641081|P5|Participant Flow|Sequence 5|Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
92318|NCT01641081|P4|Participant Flow|Sequence 4|Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
92319|NCT01641081|P3|Participant Flow|Sequence 3|Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
92320|NCT01641081|P2|Participant Flow|Sequence 2|12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
92321|NCT01641081|P1|Participant Flow|Sequence 1|24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
92322|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
92323|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
92324|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
92325|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
92326|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
92327|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
92328|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
92329|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
92330|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
92331|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
92332|NCT01641081|E5|Reported Event|Placebo|Administered via Pressair
92333|NCT01641081|E4|Reported Event|Formoterol 6 μg|Administered via Pressair
92334|NCT01641081|E3|Reported Event|Formoterol 12 μg|Administered via Pressair
92335|NCT01641081|E2|Reported Event|Foradil 12 μg|Administered via Aerolizer
92336|NCT01641081|E1|Reported Event|Foradil 24 μg|Administered via Aerolizer
92337|NCT01640964|B4|Baseline|Total|Total of all reporting groups
92338|NCT01640964|B3|Baseline|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92339|NCT01640964|B2|Baseline|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92340|NCT01640964|B1|Baseline|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
92341|NCT01640964|P3|Participant Flow|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92342|NCT01640964|P2|Participant Flow|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92343|NCT01640964|P1|Participant Flow|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
92344|NCT01640964|O2|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92345|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92346|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92347|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92348|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92349|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92350|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92351|NCT01640964|O1|Outcome|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
92376|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92352|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92353|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92354|NCT01640964|E3|Reported Event|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
92355|NCT01640964|E2|Reported Event|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
92356|NCT01640964|E1|Reported Event|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
92357|NCT01640925|B3|Baseline|Total|Total of all reporting groups
92358|NCT01640925|B2|Baseline|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
92359|NCT01640925|B1|Baseline|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
92360|NCT01640925|P2|Participant Flow|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
92361|NCT01640925|P1|Participant Flow|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
92362|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
92363|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
92364|NCT01640925|E2|Reported Event|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
92365|NCT01640925|E1|Reported Event|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
92366|NCT01640548|B1|Baseline|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92367|NCT01640548|P1|Participant Flow|Rheumatoid Arthritis (RA) Cohort|Participants on biologic disease modifying anti-rheumatic drug (bDMARD) monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92368|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92369|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92370|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92371|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92372|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92373|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92374|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92375|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92403|NCT01640327|B1|Baseline|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92377|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92378|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92379|NCT01640548|E1|Reported Event|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
92380|NCT01640340|B3|Baseline|Total|Total of all reporting groups
92381|NCT01640340|B2|Baseline|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92382|NCT01640340|B1|Baseline|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92383|NCT01640340|P2|Participant Flow|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92384|NCT01640340|P1|Participant Flow|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92385|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92386|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92387|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92388|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92389|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92390|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92391|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92392|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92393|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92394|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92395|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92396|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92397|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92398|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
92399|NCT01640340|E2|Reported Event|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92400|NCT01640340|E1|Reported Event|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
92401|NCT01640327|B3|Baseline|Total|Total of all reporting groups
92402|NCT01640327|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
92409|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92410|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
92411|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92412|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
92413|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92414|NCT01640327|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
92415|NCT01640327|E1|Reported Event|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
92416|NCT01640314|B3|Baseline|Total|Total of all reporting groups
92417|NCT01640314|B2|Baseline|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92418|NCT01640314|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92419|NCT01640314|P2|Participant Flow|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92420|NCT01640314|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92421|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92422|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92423|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92424|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92425|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92426|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92427|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92428|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92429|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92430|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92431|NCT01640314|E2|Reported Event|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
92432|NCT01640314|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
92433|NCT01640197|B3|Baseline|Total|Total of all reporting groups
92434|NCT01640197|B2|Baseline|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92435|NCT01640197|B1|Baseline|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92436|NCT01640197|P2|Participant Flow|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92437|NCT01640197|P1|Participant Flow|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92438|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92439|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92440|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92441|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92442|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92443|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92444|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92445|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92446|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92447|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92448|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92449|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92450|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92451|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92452|NCT01640197|E2|Reported Event|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
92453|NCT01640197|E1|Reported Event|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
92455|NCT01640184|B3|Baseline|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92456|NCT01640184|B2|Baseline|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92457|NCT01640184|B1|Baseline|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92458|NCT01640184|P3|Participant Flow|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92459|NCT01640184|P2|Participant Flow|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92460|NCT01640184|P1|Participant Flow|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92461|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92462|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92463|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92464|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92465|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92466|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92467|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92468|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92551|NCT01639560|B2|Baseline|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92552|NCT01639560|B1|Baseline|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92469|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92470|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92471|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92472|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92473|NCT01640184|O2|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92474|NCT01640184|O1|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92475|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92476|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92477|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92478|NCT01640184|E3|Reported Event|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
92479|NCT01640184|E2|Reported Event|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
92480|NCT01640184|E1|Reported Event|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
92481|NCT01640171|B1|Baseline|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow Eye:~Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
92482|NCT01640171|P1|Participant Flow|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye Same as above plus Xylocaine 2% SC"
92483|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
92484|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
92485|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
92486|NCT01640171|E2|Reported Event|Subconjunctival Anesthesia|"Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
92487|NCT01640171|E1|Reported Event|Topical Anesthesia|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
92488|NCT01640054|B1|Baseline|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92489|NCT01640054|P1|Participant Flow|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92490|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92491|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92492|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92493|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92494|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92495|NCT01640054|E1|Reported Event|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
92496|NCT01639833|B3|Baseline|Total|Total of all reporting groups
92497|NCT01639833|B2|Baseline|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
92498|NCT01639833|B1|Baseline|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
92499|NCT01639833|P2|Participant Flow|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
92500|NCT01639833|P1|Participant Flow|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
92501|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
92502|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
92503|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
92504|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
92505|NCT01639833|E2|Reported Event|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
92506|NCT01639833|E1|Reported Event|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
92507|NCT01639755|B1|Baseline|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92508|NCT01639755|P1|Participant Flow|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92509|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92510|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92511|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92512|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92513|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92514|NCT01639755|E1|Reported Event|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
92515|NCT01639742|B1|Baseline|All Participants|All participants who had new texture round breast implants surgically implanted.
92516|NCT01639742|P1|Participant Flow|All Participants|All participants who had new texture round breast implants surgically implanted.
92517|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
92518|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
92519|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
92520|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
92521|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
92522|NCT01639742|E1|Reported Event|All Participants|All participants who had new texture round breast implants surgically implanted.
92553|NCT01639560|P2|Participant Flow|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92554|NCT01639560|P1|Participant Flow|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92645|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92523|NCT01639729|B1|Baseline|Treatment A, Followed by Treatment B, C and D in Random Order|Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.
92524|NCT01639729|P6|Participant Flow|Sequence 6: Treatments A, D, C, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92525|NCT01639729|P5|Participant Flow|Sequence Five: Treatments A, D, B, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92526|NCT01639729|P4|Participant Flow|Sequence 4: Treatment A, C, D, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92527|NCT01639729|P3|Participant Flow|Sequence 3: Treatment A, C, B, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92528|NCT01639729|P2|Participant Flow|Sequence 2: A, B, D, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92529|NCT01639729|P1|Participant Flow|Sequence 1: Treatment A, B, C, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
92530|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92531|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92532|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92533|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92534|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92535|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92536|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92537|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92538|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92539|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92540|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92541|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92542|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92543|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92544|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92545|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
92546|NCT01639729|E4|Reported Event|Sufentanil NanoTab Oral|Sufentanil : 15 mcg oral
92547|NCT01639729|E3|Reported Event|Sufentanil NanoTab Sublingual|Sufentanil : 15 mcg sublingaul
92548|NCT01639729|E2|Reported Event|Sufentanil NanoTab Buccal|Sufentanil : 15 mcg buccal
92549|NCT01639729|E1|Reported Event|Sufentanil IV|Sufentanil : 15 mcg IV
92550|NCT01639560|B3|Baseline|Total|Total of all reporting groups
92555|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92556|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92557|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92558|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92559|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92560|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92561|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92562|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92563|NCT01639560|E2|Reported Event|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
92564|NCT01639560|E1|Reported Event|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
92565|NCT01639443|B3|Baseline|Total|Total of all reporting groups
92566|NCT01639443|B2|Baseline|Control|Patients who are scheduled routinely
92567|NCT01639443|B1|Baseline|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92568|NCT01639443|P2|Participant Flow|Control|Patients who are scheduled routinely
92569|NCT01639443|P1|Participant Flow|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92570|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92571|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92572|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92573|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92574|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92575|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92576|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92577|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92578|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92579|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92580|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
92581|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92582|NCT01639443|E2|Reported Event|Control|Patients who are scheduled routinely
92583|NCT01639443|E1|Reported Event|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
92636|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92584|NCT01639222|B1|Baseline|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
92585|NCT01639222|P1|Participant Flow|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
92586|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
92587|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
92588|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
92589|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
92590|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
92591|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
92592|NCT01639222|E2|Reported Event|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
92593|NCT01639222|E1|Reported Event|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
92594|NCT01639157|B1|Baseline|All Study Participants|Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
92595|NCT01639157|P2|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
92596|NCT01639157|P1|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
92597|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92598|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92599|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92600|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92601|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92602|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92603|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92604|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92605|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92606|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92607|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92608|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92609|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92610|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92611|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92612|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92613|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92614|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92615|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92616|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92617|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92618|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92619|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92620|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92621|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92622|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92623|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92624|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92625|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92626|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92627|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92628|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92629|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92630|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92631|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92632|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92633|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92634|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92635|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92646|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92647|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92648|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92649|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
92650|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
92651|NCT01639157|E2|Reported Event|Placebo|"Subjects will be maintained on placebo.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.These subjects will be the same as those who are maintained on buspirone (i.e., the study uses a within-subjects design)."
92652|NCT01639157|E1|Reported Event|Buspirone|"Subjects will be maintained on buspirone.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order. These subjects will be the same as those who are maintained on placebo (i.e., the study uses a within-subjects design)."
92653|NCT01639144|B3|Baseline|Total|Total of all reporting groups
92654|NCT01639144|B2|Baseline|Control|Group not receiving autogenous PRP and PPP.
92655|NCT01639144|B1|Baseline|Receiving PRP and PPP.|"Administration of PRP and PPP to surgical site.~PRP and PPP: Autogenous PRP and PPP"
92656|NCT01639144|P2|Participant Flow|Control|Group not receiving autogenous PRP and PPP.
92657|NCT01639144|P1|Participant Flow|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
92658|NCT01639144|O2|Outcome|Control|Group not receiving autogenous PRP and PPP.
92659|NCT01639144|O1|Outcome|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
92660|NCT01639144|E2|Reported Event|Control|Group not receiving autogenous PRP and PPP.
92661|NCT01639144|E1|Reported Event|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
92662|NCT01638507|B1|Baseline|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92663|NCT01638507|P1|Participant Flow|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92664|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92665|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92666|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92667|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92668|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92669|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92670|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92671|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92672|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92673|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
92674|NCT01638507|E1|Reported Event|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
92675|NCT01638468|B1|Baseline|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92676|NCT01638468|P1|Participant Flow|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92677|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92678|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92679|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92680|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92681|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92682|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92683|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92684|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92685|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92686|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92687|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92688|NCT01638468|E1|Reported Event|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
92689|NCT01638312|B3|Baseline|Total|Total of all reporting groups
92690|NCT01638312|B2|Baseline|"Healthy Controls"|The people didn't have infected HIV
92691|NCT01638312|B1|Baseline|"HIV Infected Patients"|The people had infected HIV
92692|NCT01638312|P2|Participant Flow|"Healthy Controls"|The people didn't have infected HIV
92693|NCT01638312|P1|Participant Flow|"HIV Infected Patients"|The people had infected HIV
92694|NCT01638312|O2|Outcome|"Healthy Controls"|"Healthy people~Graphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.~2.Healthy people was subjective judgments of participants, no other test as proof.~3.Graphical analysis of HIV-infected subjects"
92695|NCT01638312|O1|Outcome|"HIV Infected Patients"|20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%
92696|NCT01638312|E2|Reported Event|"Healthy Controls"|Serious and Other (Not Including Serious) Adverse Events were not collected
92697|NCT01638312|E1|Reported Event|"HIV Infected Patients"|Serious and Other (Not Including Serious) Adverse Events were not collected
92698|NCT01638000|B3|Baseline|Total|Total of all reporting groups
92699|NCT01638000|B2|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92700|NCT01638000|B1|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92701|NCT01638000|P2|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92702|NCT01638000|P1|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92703|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92704|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92705|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92706|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92707|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92708|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92709|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92710|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92711|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92712|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92713|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92714|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92715|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92716|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92717|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92718|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92719|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92720|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92721|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92722|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92723|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92724|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92725|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92726|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92727|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92728|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92729|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92730|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92731|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92732|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92733|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92734|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92735|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92736|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92737|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92738|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92739|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92740|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92741|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92742|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92743|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92744|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92745|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92746|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92747|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92748|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92749|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92750|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92751|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92752|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92753|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92754|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92755|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92756|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92757|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92758|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92759|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92760|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92761|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92762|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92763|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92764|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92765|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92766|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92767|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92768|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92769|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92770|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92771|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92772|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92773|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92774|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92775|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92776|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92777|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92778|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92779|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92780|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92781|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92782|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92783|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92784|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92785|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92786|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92787|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92788|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92789|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92790|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92791|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92792|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92793|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92794|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92795|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92796|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92797|NCT01638000|E2|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
92798|NCT01638000|E1|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
92799|NCT01637961|B1|Baseline|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92800|NCT01637961|P1|Participant Flow|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92801|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92802|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92803|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92804|NCT01637961|E1|Reported Event|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
92805|NCT01637935|B3|Baseline|Total|Total of all reporting groups
92806|NCT01637935|B2|Baseline|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92807|NCT01637935|B1|Baseline|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92808|NCT01637935|P2|Participant Flow|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92809|NCT01637935|P1|Participant Flow|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92810|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92811|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92812|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92813|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92814|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92815|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92816|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92817|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92818|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92819|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92820|NCT01637935|E2|Reported Event|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
92821|NCT01637935|E1|Reported Event|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
92822|NCT01637922|B3|Baseline|Total|Total of all reporting groups
92823|NCT01637922|B2|Baseline|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92824|NCT01637922|B1|Baseline|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92825|NCT01637922|P2|Participant Flow|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
92826|NCT01637922|P1|Participant Flow|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
92827|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92828|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92997|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92829|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92830|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92831|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92832|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92833|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92834|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92835|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92836|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92837|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92838|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92839|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92840|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92841|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92842|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92843|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92844|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92845|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92846|NCT01637922|E2|Reported Event|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92847|NCT01637922|E1|Reported Event|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
92848|NCT01637246|B1|Baseline|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92849|NCT01637246|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92850|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92851|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92852|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92853|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92854|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92855|NCT01637246|E1|Reported Event|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
92856|NCT01637090|B1|Baseline|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92875|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
92876|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
93124|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
92857|NCT01637090|P1|Participant Flow|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92858|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92859|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92860|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92861|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92862|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92863|NCT01637090|E1|Reported Event|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
92864|NCT01636986|B3|Baseline|Total|Total of all reporting groups
92865|NCT01636986|B2|Baseline|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92866|NCT01636986|B1|Baseline|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92867|NCT01636986|P2|Participant Flow|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92868|NCT01636986|P1|Participant Flow|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92869|NCT01636986|O2|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92870|NCT01636986|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92871|NCT01636986|E2|Reported Event|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92872|NCT01636986|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
92873|NCT01636960|B1|Baseline|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
92874|NCT01636960|P1|Participant Flow|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
92877|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
92878|NCT01636960|E1|Reported Event|Participants Receiving PegIFN Alfa-2b|Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
92879|NCT01636947|B3|Baseline|Total|Total of all reporting groups
92880|NCT01636947|B2|Baseline|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92881|NCT01636947|B1|Baseline|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92882|NCT01636947|P2|Participant Flow|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92883|NCT01636947|P1|Participant Flow|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
92884|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92885|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92886|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92887|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92888|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92889|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92890|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92891|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92892|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92893|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92894|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92895|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92896|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92897|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92898|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92899|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92900|NCT01636947|E2|Reported Event|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
92995|NCT01636661|P1|Participant Flow|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92901|NCT01636947|E1|Reported Event|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
92902|NCT01636778|B1|Baseline|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92903|NCT01636778|P3|Participant Flow|Eltrombopag + Antiviral Therapy: Follow-up Period After Part|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92904|NCT01636778|P2|Participant Flow|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92905|NCT01636778|P1|Participant Flow|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92906|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92907|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92908|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92909|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92910|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92911|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92912|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92913|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92914|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92915|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92916|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92917|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92918|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92919|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92920|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92921|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92922|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92923|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92924|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92925|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92926|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92927|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92928|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92929|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92930|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
93164|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
92931|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92932|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92933|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92934|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92935|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92936|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92937|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92938|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92939|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92940|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92941|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92942|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92943|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92944|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92945|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92946|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92947|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92948|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92949|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92950|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92951|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92952|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92953|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92954|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92955|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92956|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92957|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92958|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92959|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92960|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92961|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92996|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92962|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92963|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92964|NCT01636778|E3|Reported Event|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
92965|NCT01636778|E2|Reported Event|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
92966|NCT01636778|E1|Reported Event|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of &lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained &lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
92967|NCT01636765|B1|Baseline|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
92968|NCT01636765|P1|Participant Flow|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
92969|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
92970|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
92971|NCT01636765|E1|Reported Event|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
92972|NCT01636713|B4|Baseline|Total|Total of all reporting groups
92973|NCT01636713|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92974|NCT01636713|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92975|NCT01636713|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92976|NCT01636713|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92977|NCT01636713|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92978|NCT01636713|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92979|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92980|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92981|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92982|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92983|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92984|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92985|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92986|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92987|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92988|NCT01636713|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
92989|NCT01636713|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
92990|NCT01636713|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
92991|NCT01636661|B3|Baseline|Total|Total of all reporting groups
92992|NCT01636661|B2|Baseline|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92993|NCT01636661|B1|Baseline|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92994|NCT01636661|P2|Participant Flow|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
93165|NCT01635881|E1|Reported Event|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
92998|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
92999|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
93000|NCT01636661|E2|Reported Event|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
93001|NCT01636661|E1|Reported Event|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
93002|NCT01636466|B3|Baseline|Total|Total of all reporting groups
93003|NCT01636466|B2|Baseline|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
93004|NCT01636466|B1|Baseline|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
93005|NCT01636466|P2|Participant Flow|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
93006|NCT01636466|P1|Participant Flow|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
93007|NCT01636466|O2|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
93008|NCT01636466|O1|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
93009|NCT01636466|E2|Reported Event|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
93010|NCT01636466|E1|Reported Event|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
93011|NCT01636414|B4|Baseline|Total|Total of all reporting groups
93012|NCT01636414|B3|Baseline|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
93013|NCT01636414|B2|Baseline|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
93014|NCT01636414|B1|Baseline|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
93015|NCT01636414|P3|Participant Flow|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
93016|NCT01636414|P2|Participant Flow|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
93017|NCT01636414|P1|Participant Flow|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
93018|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
93019|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
93020|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
93021|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
93022|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
93023|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
93024|NCT01636414|E3|Reported Event|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
93025|NCT01636414|E2|Reported Event|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
93026|NCT01636414|E1|Reported Event|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
93027|NCT01636362|B1|Baseline|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93028|NCT01636362|P1|Participant Flow|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93075|NCT01636076|B2|Baseline|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93076|NCT01636076|B1|Baseline|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93029|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93030|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93031|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93032|NCT01636362|E1|Reported Event|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
93033|NCT01636258|B3|Baseline|Total|Total of all reporting groups
93034|NCT01636258|B2|Baseline|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
93035|NCT01636258|B1|Baseline|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93036|NCT01636258|P2|Participant Flow|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
93037|NCT01636258|P1|Participant Flow|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93038|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
93039|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93040|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
93041|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93042|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
93043|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93044|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
93045|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93046|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
93047|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93048|NCT01636258|E2|Reported Event|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
93049|NCT01636258|E1|Reported Event|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
93050|NCT01636206|B3|Baseline|Total|Total of all reporting groups
93051|NCT01636206|B2|Baseline|Lifitegrast|
93052|NCT01636206|B1|Baseline|Placebo|
93053|NCT01636206|P2|Participant Flow|Lifitegrast|
93054|NCT01636206|P1|Participant Flow|Placebo|
93055|NCT01636206|O2|Outcome|Lifitegrast|
93056|NCT01636206|O1|Outcome|Placebo|
93057|NCT01636206|E2|Reported Event|Lifitegrast|
93058|NCT01636206|E1|Reported Event|Placebo|
93059|NCT01636102|B3|Baseline|Total|Total of all reporting groups
93060|NCT01636102|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93061|NCT01636102|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93062|NCT01636102|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93063|NCT01636102|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93064|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93065|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93066|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93067|NCT01636102|O1|Outcome|18 - 60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93068|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93069|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93070|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93071|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93072|NCT01636102|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
93073|NCT01636102|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
93074|NCT01636076|B3|Baseline|Total|Total of all reporting groups
93077|NCT01636076|P2|Participant Flow|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93078|NCT01636076|P1|Participant Flow|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93079|NCT01636076|O2|Outcome|QMF149 Analyte QAB149|QMF149 analyte QAB149 ( indacaterol acetate)
93080|NCT01636076|O1|Outcome|QMF149 Analyte Mometasone Furoate|QMF149 Mometasone furoate analyte from mixture
93081|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
93082|NCT01636076|O1|Outcome|QMF 149 Anaylyte: Mometasone Furorate|Mometasone furoate as a component of QMF149F
93083|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
93084|NCT01636076|O1|Outcome|QMF149 Analyte: Mometasone Furoate|Mometasone furoate as part of QMF149F
93085|NCT01636076|O2|Outcome|QMF149 (Analyte Indacaterol Acetate)|Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
93086|NCT01636076|O1|Outcome|QMF149 (Analyte Mometasone Furoate)|Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
93087|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93088|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93089|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93090|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93091|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93092|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93093|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93094|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93095|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93096|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93097|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93098|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93099|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93100|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93101|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93102|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93103|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93104|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93105|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93106|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93107|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93108|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93109|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93110|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93111|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93112|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93113|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93114|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93115|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93116|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93117|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93118|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93119|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93120|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93121|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93122|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93123|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93125|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93126|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93127|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93128|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93129|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93130|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93131|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93132|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93133|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
93134|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93135|NCT01636076|E2|Reported Event|SALM/FLUT|SALM/FLUT
93136|NCT01636076|E1|Reported Event|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
93137|NCT01635933|B3|Baseline|Total|Total of all reporting groups
93138|NCT01635933|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93139|NCT01635933|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93140|NCT01635933|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93141|NCT01635933|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93142|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93143|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93144|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93145|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93146|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93147|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93148|NCT01635933|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93149|NCT01635933|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
93150|NCT01635920|B3|Baseline|Total|Total of all reporting groups
93151|NCT01635920|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93152|NCT01635920|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93153|NCT01635920|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93154|NCT01635920|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93155|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93156|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with print worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93157|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93158|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93159|NCT01635920|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93160|NCT01635920|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
93161|NCT01635881|B1|Baseline|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
93162|NCT01635881|P1|Participant Flow|Emerge|Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
93163|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
93166|NCT01635855|B1|Baseline|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
93167|NCT01635855|P1|Participant Flow|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
93168|NCT01635855|O1|Outcome|Belotero|Belotero®: Hyaluronic acid dermal filler
93169|NCT01635855|E1|Reported Event|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
93170|NCT01635504|B1|Baseline|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
93171|NCT01635504|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
93172|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
93173|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
93174|NCT01635504|E1|Reported Event|HIV Posterior Cheek Enlargement Group|Injected with botulinum toxin A
93175|NCT01635439|B3|Baseline|Total|Total of all reporting groups
93176|NCT01635439|B2|Baseline|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93177|NCT01635439|B1|Baseline|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93178|NCT01635439|P2|Participant Flow|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93179|NCT01635439|P1|Participant Flow|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93180|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93181|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93182|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93183|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93184|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93185|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93186|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93187|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93188|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93189|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93190|NCT01635439|E2|Reported Event|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
93191|NCT01635439|E1|Reported Event|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
93192|NCT01635244|B4|Baseline|Total|Total of all reporting groups
93193|NCT01635244|B3|Baseline|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93194|NCT01635244|B2|Baseline|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93195|NCT01635244|B1|Baseline|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93196|NCT01635244|P3|Participant Flow|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93197|NCT01635244|P2|Participant Flow|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93198|NCT01635244|P1|Participant Flow|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93199|NCT01635244|O3|Outcome|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93572|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93200|NCT01635244|O2|Outcome|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93201|NCT01635244|O1|Outcome|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93202|NCT01635244|E3|Reported Event|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93203|NCT01635244|E2|Reported Event|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93204|NCT01635244|E1|Reported Event|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
93205|NCT01635218|B4|Baseline|Total|Total of all reporting groups
93206|NCT01635218|B3|Baseline|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93207|NCT01635218|B2|Baseline|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93208|NCT01635218|B1|Baseline|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93209|NCT01635218|P3|Participant Flow|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93210|NCT01635218|P2|Participant Flow|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93211|NCT01635218|P1|Participant Flow|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93212|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93213|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93214|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93215|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93216|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93217|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93218|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93823|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93219|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93220|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93221|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93222|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93223|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93224|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93225|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
93226|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93227|NCT01635218|E3|Reported Event|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
93228|NCT01635218|E2|Reported Event|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4."
93229|NCT01635218|E1|Reported Event|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
93230|NCT01634659|B3|Baseline|Total|Total of all reporting groups
93231|NCT01634659|B2|Baseline|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
93232|NCT01634659|B1|Baseline|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
93233|NCT01634659|P2|Participant Flow|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
93234|NCT01634659|P1|Participant Flow|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
93235|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93236|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93237|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93238|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93239|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93240|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93241|NCT01634659|E2|Reported Event|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93242|NCT01634659|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
93243|NCT01634620|B1|Baseline|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93244|NCT01634620|P1|Participant Flow|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93245|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93246|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
93247|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
93248|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
93249|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
93250|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
93251|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
93252|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
93253|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
93254|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
93269|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
93255|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93256|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93257|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93258|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93259|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93260|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93261|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93262|NCT01634620|E1|Reported Event|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
93263|NCT01634555|B1|Baseline|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
93264|NCT01634555|P1|Participant Flow|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle"
93265|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
93266|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
93267|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
93268|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
93824|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93270|NCT01634555|E1|Reported Event|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
93271|NCT01634360|B3|Baseline|Total|Total of all reporting groups
93272|NCT01634360|B2|Baseline|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93273|NCT01634360|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93274|NCT01634360|P2|Participant Flow|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93275|NCT01634360|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93276|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93277|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93278|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93279|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93280|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93281|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93282|NCT01634360|E2|Reported Event|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93283|NCT01634360|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
93284|NCT01634256|B3|Baseline|Total|Total of all reporting groups
93285|NCT01634256|B2|Baseline|Placebo|
93286|NCT01634256|B1|Baseline|Fermented Curcuma|
93287|NCT01634256|P2|Participant Flow|Placebo|"Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Fermented turmeric."
93288|NCT01634256|P1|Participant Flow|Fermented Turmeric|"Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks~Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours."
93289|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93290|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
93291|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93292|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
93293|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93294|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
93295|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93296|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
93297|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93298|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
93299|NCT01634256|E2|Reported Event|Placebo|Oral intake placebo(3.0g/day) for 12weeks
93300|NCT01634256|E1|Reported Event|Fermented Curcuma|Oral intake fermented curcuma (3.0g/day) for 12weeks.
93301|NCT01634243|B3|Baseline|Total|Total of all reporting groups
93302|NCT01634243|B2|Baseline|Advanced Parkinson's Disease|
93303|NCT01634243|B1|Baseline|Early-stage Parkinson's Disease|
93304|NCT01634243|P2|Participant Flow|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93305|NCT01634243|P1|Participant Flow|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93306|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93307|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93308|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93309|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93310|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93311|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93312|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93313|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93314|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93315|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93316|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93317|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93318|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93319|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93320|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93321|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93322|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93323|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93324|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93325|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93326|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
93327|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
93328|NCT01634243|E2|Reported Event|Advanced Parkinson's Disease|
93329|NCT01634243|E1|Reported Event|Early-stage Parkinson's Disease|
93330|NCT01634165|B1|Baseline|All Participants|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93331|NCT01634165|P4|Participant Flow|0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY|Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
93332|NCT01634165|P3|Participant Flow|0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY|Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
93333|NCT01634165|P2|Participant Flow|0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
93334|NCT01634165|P1|Participant Flow|0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
93335|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93336|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93337|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93338|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93339|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93340|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93341|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93342|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93343|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93344|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93345|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93346|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93347|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93348|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93349|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93350|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93351|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93352|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93353|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93354|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93355|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93356|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93357|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93358|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93359|NCT01634165|E4|Reported Event|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93360|NCT01634165|E3|Reported Event|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93361|NCT01634165|E2|Reported Event|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93362|NCT01634165|E1|Reported Event|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
93363|NCT01634152|B4|Baseline|Total|Total of all reporting groups
93364|NCT01634152|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93365|NCT01634152|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93366|NCT01634152|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93367|NCT01634152|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93368|NCT01634152|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93369|NCT01634152|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93370|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93371|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93372|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93373|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93374|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93375|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93376|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93377|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93378|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93379|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93380|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93381|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93382|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93383|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93384|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93385|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93386|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93387|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93388|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93389|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93390|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93391|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93825|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93392|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93393|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93394|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93395|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93396|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93397|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93398|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93399|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93400|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93401|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93402|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93403|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93404|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93405|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93406|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93407|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93408|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93409|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93410|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93411|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93412|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93413|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93414|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93415|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93416|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93417|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93418|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93419|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93420|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93421|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93422|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93423|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93424|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93425|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93426|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93427|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93428|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93429|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93430|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93431|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93432|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93433|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93434|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93435|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93436|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93437|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93438|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93439|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93440|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93441|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93442|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93443|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93444|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93445|NCT01634152|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93446|NCT01634152|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93447|NCT01634152|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93448|NCT01634139|B4|Baseline|Total|Total of all reporting groups
93449|NCT01634139|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93450|NCT01634139|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93451|NCT01634139|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93452|NCT01634139|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93453|NCT01634139|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93454|NCT01634139|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93455|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93456|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93457|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93458|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93459|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93460|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93461|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93462|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93463|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93464|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93465|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93466|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93467|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93468|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93469|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93470|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93471|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93472|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93473|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93474|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93475|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93476|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93477|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93478|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93479|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93480|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93481|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93482|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93483|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93484|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93485|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93486|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93487|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93488|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93489|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93490|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93491|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93492|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93493|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93494|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93495|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93496|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93497|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93498|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93499|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93500|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93501|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93502|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93503|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93504|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93505|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93506|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93507|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93508|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93509|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93510|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93511|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93512|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93513|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93514|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93515|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93516|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93517|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93518|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93519|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93520|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93521|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93522|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93523|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93524|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93525|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93526|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93527|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93528|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93529|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93530|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93571|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93531|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93532|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93533|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93534|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93535|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93536|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93537|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93538|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93539|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93540|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93541|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93542|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93543|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93544|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93545|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93546|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93547|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93548|NCT01634139|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93549|NCT01634139|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93550|NCT01634139|E1|Reported Event|Placebo|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
93551|NCT01634113|B4|Baseline|Total|Total of all reporting groups
93552|NCT01634113|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93553|NCT01634113|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93554|NCT01634113|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93555|NCT01634113|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93556|NCT01634113|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93557|NCT01634113|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93558|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93559|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93560|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93561|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93562|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93563|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93564|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93565|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93566|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93567|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93568|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93569|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93570|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93826|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93573|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93574|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93575|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93576|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93577|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93578|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93579|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93580|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93581|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93582|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93583|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93584|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93585|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93586|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93587|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93588|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93589|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93590|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93591|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93592|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93593|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93594|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93595|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93596|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93597|NCT01634113|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
93598|NCT01634113|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
93599|NCT01634113|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
93600|NCT01634100|B1|Baseline|Study Overall|This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
93601|NCT01634100|P6|Participant Flow|Empa + Probenecid / Empa + Rifampicin / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
93602|NCT01634100|P5|Participant Flow|Empa + Probenecid / Empa Alone / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
93603|NCT01634100|P4|Participant Flow|Empa + Rifampicin / Empa + Probenecid / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
93604|NCT01634100|P3|Participant Flow|Empa + Rifampicin / Empa Alone / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
93605|NCT01634100|P2|Participant Flow|Empa Alone / Empa + Probenecid / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
93606|NCT01634100|P1|Participant Flow|Empa Alone / Empa + Rifampicin / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
93607|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
93608|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
93609|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
93610|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
93611|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
93612|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
93613|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
93614|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
93615|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
93616|NCT01634100|E3|Reported Event|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
93617|NCT01634100|E2|Reported Event|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
93618|NCT01634100|E1|Reported Event|Empa Alone|A single dose of 10mg of empagliflozin (empa).
93619|NCT01633944|B3|Baseline|Total|Total of all reporting groups
93620|NCT01633944|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93621|NCT01633944|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93622|NCT01633944|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93623|NCT01633944|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93624|NCT01633944|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
93625|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93626|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93627|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93628|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93629|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93630|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93631|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93632|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93633|NCT01633944|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
93634|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93635|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93636|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93637|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93638|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93639|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93640|NCT01633944|E3|Reported Event|DB Placebo Film|Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93641|NCT01633944|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
93642|NCT01633944|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase
93643|NCT01633853|B3|Baseline|Total|Total of all reporting groups
93644|NCT01633853|B2|Baseline|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93749|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93645|NCT01633853|B1|Baseline|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93646|NCT01633853|P2|Participant Flow|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93647|NCT01633853|P1|Participant Flow|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93648|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93649|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93650|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93651|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93652|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93653|NCT01633853|O1|Outcome|Vitamin D2 Treatment|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93654|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93655|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93656|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93657|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93658|NCT01633853|E2|Reported Event|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
93659|NCT01633853|E1|Reported Event|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
93660|NCT01633320|B3|Baseline|Total|Total of all reporting groups
93661|NCT01633320|B2|Baseline|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
93662|NCT01633320|B1|Baseline|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
93663|NCT01633320|P2|Participant Flow|NRS>3 (Moderate to Severe Pain)|Patients with numerical rating scale pain score >3 at arrival in PACU
93664|NCT01633320|P1|Participant Flow|NRS<=3 (no or Mild Pain)|Patients with numerical rating pain scale <=3 at arrival in PACU
93665|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
93666|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
93667|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
93668|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
93669|NCT01633320|E2|Reported Event|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
93670|NCT01633320|E1|Reported Event|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
93671|NCT01632904|B3|Baseline|Total|Total of all reporting groups
93672|NCT01632904|B2|Baseline|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
93673|NCT01632904|B1|Baseline|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
93827|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93674|NCT01632904|P2|Participant Flow|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
93675|NCT01632904|P1|Participant Flow|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
93676|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
93677|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
93678|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
93679|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
93680|NCT01632904|E2|Reported Event|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
93681|NCT01632904|E1|Reported Event|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
93682|NCT01632878|B3|Baseline|Total|Total of all reporting groups
93683|NCT01632878|B2|Baseline|Post Myocardial Infarction Non-Omacor Group|Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
93684|NCT01632878|B1|Baseline|Post Myocardial Infarction Omacor Group|Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
93685|NCT01632878|P1|Participant Flow|Post Myocardial Infarction|One single cohort of Index post Myocardial Infarction patients
93686|NCT01632878|O1|Outcome|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
93687|NCT01632878|E1|Reported Event|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
93688|NCT01632800|B1|Baseline|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
93689|NCT01632800|P1|Participant Flow|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
93690|NCT01632800|O1|Outcome|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
93691|NCT01632800|E1|Reported Event|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
93692|NCT01632735|B3|Baseline|Total|Total of all reporting groups
93693|NCT01632735|B2|Baseline|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93694|NCT01632735|B1|Baseline|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93695|NCT01632735|P2|Participant Flow|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93696|NCT01632735|P1|Participant Flow|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93697|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93750|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94004|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
93698|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93699|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93700|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93701|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93702|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93703|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93704|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93705|NCT01632735|E2|Reported Event|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
93706|NCT01632735|E1|Reported Event|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
93707|NCT01632709|B5|Baseline|Total|Total of all reporting groups
93708|NCT01632709|B4|Baseline|Dry Needling at the Neuroma|
93709|NCT01632709|B3|Baseline|Neuroma Injection of Bupivacaine|
93710|NCT01632709|B2|Baseline|Dry Needling at Sympathetic Ganglion|
93711|NCT01632709|B1|Baseline|Sympathetic Nerve Block of Bupivacaine|
93712|NCT01632709|P4|Participant Flow|Dry Needling at the Neuroma|
93713|NCT01632709|P3|Participant Flow|Neuroma Injection of Bupivacaine|
93714|NCT01632709|P2|Participant Flow|Dry Needling at Sympathetic Ganglion|
93715|NCT01632709|P1|Participant Flow|Sympathetic Nerve Block of Bupivacaine|
93716|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
93717|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93718|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
93719|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93720|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
93721|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93722|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
93723|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93724|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
93725|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93726|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
93727|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93728|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
93729|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93730|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
93731|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93732|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
93733|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93734|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
93735|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
93736|NCT01632709|E2|Reported Event|Treatment Group|
93737|NCT01632709|E1|Reported Event|Placebo/Sham Injection|
93738|NCT01632683|B3|Baseline|Total|Total of all reporting groups
93739|NCT01632683|B2|Baseline|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
93740|NCT01632683|B1|Baseline|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
93741|NCT01632683|P2|Participant Flow|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
93742|NCT01632683|P1|Participant Flow|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
93743|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
93744|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
93745|NCT01632683|E2|Reported Event|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
93746|NCT01632683|E1|Reported Event|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
93747|NCT01632423|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93748|NCT01632423|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93751|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93752|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93753|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93754|NCT01632423|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
93755|NCT01632267|B1|Baseline|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
93756|NCT01632267|P1|Participant Flow|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
93757|NCT01632267|O1|Outcome|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
93758|NCT01632267|E1|Reported Event|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
93759|NCT01632215|B3|Baseline|Total|Total of all reporting groups
93760|NCT01632215|B2|Baseline|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
93761|NCT01632215|B1|Baseline|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
93762|NCT01632215|P2|Participant Flow|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
93763|NCT01632215|P1|Participant Flow|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
93764|NCT01632215|O2|Outcome|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
93765|NCT01632215|O1|Outcome|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
93766|NCT01632215|E2|Reported Event|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
93767|NCT01632215|E1|Reported Event|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
93768|NCT01632150|B1|Baseline|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
93769|NCT01632150|P1|Participant Flow|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
93770|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
93771|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
93772|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
93816|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93817|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93818|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93819|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93820|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93821|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93822|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94005|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
93773|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
93774|NCT01632150|E1|Reported Event|All Treated Subjects|
93775|NCT01632020|B3|Baseline|Total|Total of all reporting groups
93776|NCT01632020|B2|Baseline|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
93777|NCT01632020|B1|Baseline|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
93778|NCT01632020|P2|Participant Flow|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
93779|NCT01632020|P1|Participant Flow|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
93780|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
93781|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
93782|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
93783|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
93784|NCT01632020|E2|Reported Event|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
93785|NCT01632020|E1|Reported Event|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
93786|NCT01631929|B3|Baseline|Total|Total of all reporting groups
93787|NCT01631929|B2|Baseline|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
93788|NCT01631929|B1|Baseline|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
93789|NCT01631929|P2|Participant Flow|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
93790|NCT01631929|P1|Participant Flow|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
93791|NCT01631929|O2|Outcome|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
93792|NCT01631929|O1|Outcome|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
93793|NCT01631929|E2|Reported Event|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
93794|NCT01631929|E1|Reported Event|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
93795|NCT01631864|B3|Baseline|Total|Total of all reporting groups
93796|NCT01631864|B2|Baseline|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93797|NCT01631864|B1|Baseline|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93798|NCT01631864|P2|Participant Flow|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93799|NCT01631864|P1|Participant Flow|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93800|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93801|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93802|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93803|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93804|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93805|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93806|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93807|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
93808|NCT01631864|E2|Reported Event|Amlodipine|Amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
93809|NCT01631864|E1|Reported Event|LCZ696|LCZ696 400 mg plus placebo to Amlodipine once daily for 8 weeks
93810|NCT01631825|B1|Baseline|SPM 962|SPM 962 transdermal patch
93811|NCT01631825|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
93812|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93813|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93814|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93815|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93828|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93829|NCT01631825|E1|Reported Event|SPM 962|SPM 962 transdermal patch
93830|NCT01631812|B1|Baseline|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
93831|NCT01631812|P1|Participant Flow|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
93832|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93833|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93834|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93835|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93836|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
93837|NCT01631812|E1|Reported Event|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
93838|NCT01631630|B3|Baseline|Total|Total of all reporting groups
93839|NCT01631630|B2|Baseline|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93840|NCT01631630|B1|Baseline|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93841|NCT01631630|P2|Participant Flow|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93842|NCT01631630|P1|Participant Flow|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93843|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93844|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93845|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93846|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93847|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93848|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93849|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93850|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93851|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93852|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93853|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93854|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93855|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93856|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93857|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93858|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93859|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93860|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93861|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93862|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93863|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93864|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93865|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93866|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93867|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93868|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93869|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93870|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93871|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93872|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93873|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93874|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93875|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93876|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93877|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93878|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93879|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93880|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93881|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93882|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93883|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93884|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93885|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93886|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93887|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93888|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93889|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93890|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93891|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93892|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93893|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93894|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93895|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93896|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93897|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93898|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93899|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93900|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93901|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93902|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93903|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93904|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93905|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93906|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93907|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93908|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93909|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93910|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93911|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93912|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93913|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93914|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93915|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93916|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93917|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93918|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93919|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93920|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93921|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93922|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93923|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93924|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93925|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93926|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93927|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93928|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93929|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93930|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93931|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93932|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93933|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93934|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93935|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93936|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93937|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93938|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93939|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93940|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93941|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93942|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93943|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93944|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93945|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93946|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93947|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93948|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93949|NCT01631630|E2|Reported Event|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
93950|NCT01631630|E1|Reported Event|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
93951|NCT01631435|B1|Baseline|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
93952|NCT01631435|P1|Participant Flow|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
93953|NCT01631435|O2|Outcome|# Casesclassified as “Active CD is Likely” by IC|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure.~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
93954|NCT01631435|O1|Outcome|# Casesclassified as “Active CD is Likely” by CE|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE).~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
93955|NCT01631435|E1|Reported Event|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
93956|NCT01631227|B3|Baseline|Total|Total of all reporting groups
93957|NCT01631227|B2|Baseline|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
93958|NCT01631227|B1|Baseline|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
93959|NCT01631227|P2|Participant Flow|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
93960|NCT01631227|P1|Participant Flow|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
93961|NCT01631227|O2|Outcome|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
93962|NCT01631227|O1|Outcome|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
93963|NCT01631227|E2|Reported Event|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
93964|NCT01631227|E1|Reported Event|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
93965|NCT01631149|B3|Baseline|Total|Total of all reporting groups
93966|NCT01631149|B2|Baseline|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93967|NCT01631149|B1|Baseline|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93968|NCT01631149|P2|Participant Flow|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93969|NCT01631149|P1|Participant Flow|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93970|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93971|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93972|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93973|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93974|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93975|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93976|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93977|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93978|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93979|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93980|NCT01631149|E2|Reported Event|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
93981|NCT01631149|E1|Reported Event|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
93982|NCT01631110|B3|Baseline|Total|Total of all reporting groups
93983|NCT01631110|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
93984|NCT01631110|B1|Baseline|Elderly Subjects Aged Over 60 Years|
93985|NCT01631110|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
93986|NCT01631110|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
93987|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
93988|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
93989|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
93990|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
93991|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
93992|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
93993|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
93994|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
93995|NCT01631110|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
93996|NCT01631110|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
93997|NCT01631071|B3|Baseline|Total|Total of all reporting groups
93998|NCT01631071|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
93999|NCT01631071|B1|Baseline|Elderly Subjects Aged Over 60 Years|
94000|NCT01631071|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
94001|NCT01631071|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
94002|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
94003|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
94010|NCT01631071|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
94011|NCT01631071|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
94012|NCT01630694|B3|Baseline|Total|Total of all reporting groups
94013|NCT01630694|B2|Baseline|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94014|NCT01630694|B1|Baseline|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94015|NCT01630694|P2|Participant Flow|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94016|NCT01630694|P1|Participant Flow|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94017|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94018|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94019|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94020|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94021|NCT01630694|E2|Reported Event|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94022|NCT01630694|E1|Reported Event|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
94023|NCT01630135|B3|Baseline|Total|Total of all reporting groups
94024|NCT01630135|B2|Baseline|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94025|NCT01630135|B1|Baseline|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94026|NCT01630135|P2|Participant Flow|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94027|NCT01630135|P1|Participant Flow|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94028|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94029|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94030|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94031|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94032|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94033|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94034|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94035|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94036|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94037|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94038|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94039|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94040|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94185|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94041|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94042|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94043|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94044|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94045|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94046|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94047|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94048|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94049|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94050|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94051|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94052|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94053|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94054|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94055|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94056|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94057|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94058|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94059|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94060|NCT01630135|E2|Reported Event|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
94061|NCT01630135|E1|Reported Event|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
94062|NCT01630109|B4|Baseline|Total|Total of all reporting groups
94063|NCT01630109|B3|Baseline|Placebo Control|Placebo to be used as the control group
94064|NCT01630109|B2|Baseline|Metoclopramide 10 mg|Pro-motility agent
94065|NCT01630109|B1|Baseline|Metoclopramide 5 mg|Pro-motility agent
94066|NCT01630109|P3|Participant Flow|Placebo Control|Placebo to be used as the control group
94067|NCT01630109|P2|Participant Flow|Metoclopramide 10 mg|Pro-motility agent
94068|NCT01630109|P1|Participant Flow|Metoclopramide 5 mg|Pro-motility agent
94069|NCT01630109|O6|Outcome|Placebo (Non-diabetic)|Placebo control given to non-diabetics
94070|NCT01630109|O5|Outcome|Metoclopramide 10 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
94071|NCT01630109|O4|Outcome|Metoclopramide 5 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
94072|NCT01630109|O3|Outcome|Placebo Control (Diabetics)|Placebo to be used as the control group in diabetic patients
94073|NCT01630109|O2|Outcome|Metoclopramide 10 mg (Diabetics)|Pro-motility agent given to diabetic patients
94074|NCT01630109|O1|Outcome|Metoclopramide 5 mg (Diabetics)|Pro-motility agent given to diabetic patients
94075|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
94076|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
94077|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
94078|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
94079|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
94080|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
94081|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
94082|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
94083|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
94084|NCT01630109|E3|Reported Event|Placebo Control|Placebo to be used as the control group
94085|NCT01630109|E2|Reported Event|Metoclopramide 10 mg|Pro-motility agent
94086|NCT01630109|E1|Reported Event|Metoclopramide 5 mg|Pro-motility agent
94141|NCT01629693|B2|Baseline|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94142|NCT01629693|B1|Baseline|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94186|NCT01628965|E1|Reported Event|SPM 962|SPM 962 transdermal patch
94087|NCT01629797|B1|Baseline|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
94088|NCT01629797|P1|Participant Flow|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
94089|NCT01629797|O2|Outcome|Two Months Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
94090|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
94091|NCT01629797|O2|Outcome|Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
94092|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
94093|NCT01629797|E1|Reported Event|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
94094|NCT01629784|B1|Baseline|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
94095|NCT01629784|P1|Participant Flow|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
94096|NCT01629784|O2|Outcome|Three Months Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
94097|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
94098|NCT01629784|O2|Outcome|Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
94099|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
94187|NCT01628926|B4|Baseline|Total|Total of all reporting groups
94100|NCT01629784|E1|Reported Event|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
94101|NCT01629771|B3|Baseline|Total|Total of all reporting groups
94102|NCT01629771|B2|Baseline|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94103|NCT01629771|B1|Baseline|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94104|NCT01629771|P2|Participant Flow|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94105|NCT01629771|P1|Participant Flow|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94106|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94107|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94108|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94109|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94110|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94111|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94112|NCT01629771|E2|Reported Event|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
94113|NCT01629771|E1|Reported Event|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
94114|NCT01629706|B1|Baseline|Overall|All enrolled participants
94115|NCT01629706|P1|Participant Flow|PureVision/Habitual|Phase 1: Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care.
94116|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94117|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94118|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94119|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94120|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94121|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94122|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94123|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94124|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94125|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94126|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94127|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
94128|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
94129|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
94130|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
94131|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
94132|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
94133|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
94134|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
94135|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
94136|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
94137|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
94138|NCT01629706|E2|Reported Event|Habitual|Habitual contact lenses worn in Phase 2
94139|NCT01629706|E1|Reported Event|PureVision|Balafilcon A contact lenses worn in Phase 1
94140|NCT01629693|B3|Baseline|Total|Total of all reporting groups
94184|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94143|NCT01629693|P2|Participant Flow|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94144|NCT01629693|P1|Participant Flow|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94145|NCT01629693|O2|Outcome|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94146|NCT01629693|O1|Outcome|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94147|NCT01629693|E2|Reported Event|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94148|NCT01629693|E1|Reported Event|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
94149|NCT01629589|B3|Baseline|Total|Total of all reporting groups
94150|NCT01629589|B2|Baseline|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94151|NCT01629589|B1|Baseline|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94152|NCT01629589|P2|Participant Flow|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94153|NCT01629589|P1|Participant Flow|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94154|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94155|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94156|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94157|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94158|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94159|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94160|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94161|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94162|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94163|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94164|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94165|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94166|NCT01629589|E2|Reported Event|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
94167|NCT01629589|E1|Reported Event|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
94168|NCT01629134|B1|Baseline|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94169|NCT01629134|P1|Participant Flow|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94170|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94171|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94172|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94173|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94174|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94175|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94176|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94177|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94178|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94179|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94180|NCT01629134|E1|Reported Event|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
94181|NCT01628965|B1|Baseline|SPM 962|SPM 962 transdermal patch
94182|NCT01628965|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
94183|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94188|NCT01628926|B3|Baseline|Placebo|SPM962 placebo patch and Ropinirole placebo tab
94189|NCT01628926|B2|Baseline|Ropinirole|Ropinirole tablet
94190|NCT01628926|B1|Baseline|SPM 962|SPM 962 transdermal patch
94191|NCT01628926|P3|Participant Flow|Placebo|SPM962 placebo patch and Ropinirole placebo tab
94192|NCT01628926|P2|Participant Flow|Ropinirole|Ropinirole tablet
94193|NCT01628926|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
94194|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94195|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94196|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94197|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
94198|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94199|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94200|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94201|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94202|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94203|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94204|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94205|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94206|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94207|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94208|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94209|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94210|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94211|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94212|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
94213|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94214|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94215|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94216|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94217|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94218|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94219|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94220|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94221|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94222|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94223|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94224|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94225|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94226|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94227|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94228|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94229|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94230|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94231|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94232|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94233|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
94234|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
94235|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
94236|NCT01628926|E3|Reported Event|Placebo|SPM962 placebo patch and Ropinirole placebo tab
94237|NCT01628926|E2|Reported Event|Ropinirole|Ropinirole tablet
94238|NCT01628926|E1|Reported Event|SPM 962|SPM 962 transdermal patch
94239|NCT01628913|B3|Baseline|Total|Total of all reporting groups
94240|NCT01628913|B2|Baseline|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94241|NCT01628913|B1|Baseline|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94242|NCT01628913|P2|Participant Flow|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94243|NCT01628913|P1|Participant Flow|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94244|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94245|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94246|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94247|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94248|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94249|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94250|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94251|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94252|NCT01628913|E2|Reported Event|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
94253|NCT01628913|E1|Reported Event|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
94254|NCT01628848|B3|Baseline|Total|Total of all reporting groups
94286|NCT01628692|B6|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94287|NCT01628692|B5|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94288|NCT01628692|B4|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94289|NCT01628692|B3|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94290|NCT01628692|B2|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94291|NCT01628692|B1|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94292|NCT01628692|P6|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94293|NCT01628692|P5|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94294|NCT01628692|P4|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94295|NCT01628692|P3|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94296|NCT01628692|P2|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94297|NCT01628692|P1|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94298|NCT01628692|O3|Outcome|Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94299|NCT01628692|O2|Outcome|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94351|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94352|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94300|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94301|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94302|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94303|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94304|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94305|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94306|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94307|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94308|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94309|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94310|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94311|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94312|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94313|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94314|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94353|NCT01628601|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94315|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94316|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94317|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94318|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94319|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94320|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94321|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94322|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94323|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up
94324|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94325|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94326|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94327|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94328|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94329|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94330|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94331|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
94332|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94333|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
94334|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94335|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94336|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94337|NCT01628692|E3|Reported Event|Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
94338|NCT01628692|E2|Reported Event|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
94339|NCT01628692|E1|Reported Event|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
94340|NCT01628614|B1|Baseline|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94341|NCT01628614|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94342|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94343|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94344|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94345|NCT01628614|E1|Reported Event|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
94346|NCT01628601|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94347|NCT01628601|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94348|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94349|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94350|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
94354|NCT01628588|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94355|NCT01628588|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94356|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94357|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94358|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94359|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94360|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94361|NCT01628588|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
94362|NCT01628510|B3|Baseline|Total|Total of all reporting groups
94363|NCT01628510|B2|Baseline|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
94364|NCT01628510|B1|Baseline|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
94365|NCT01628510|P2|Participant Flow|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
94366|NCT01628510|P1|Participant Flow|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
94367|NCT01628510|O2|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
94368|NCT01628510|O1|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
94369|NCT01628510|E2|Reported Event|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
94370|NCT01628510|E1|Reported Event|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
94371|NCT01628367|B3|Baseline|Total|Total of all reporting groups
94372|NCT01628367|B2|Baseline|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94373|NCT01628367|B1|Baseline|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94449|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94450|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94374|NCT01628367|P2|Participant Flow|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94375|NCT01628367|P1|Participant Flow|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94376|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94377|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94378|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94379|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94380|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94381|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94382|NCT01628367|E2|Reported Event|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
94383|NCT01628367|E1|Reported Event|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
94384|NCT01628250|B3|Baseline|Total|Total of all reporting groups
94385|NCT01628250|B2|Baseline|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
94386|NCT01628250|B1|Baseline|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
94387|NCT01628250|P2|Participant Flow|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
94388|NCT01628250|P1|Participant Flow|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
94389|NCT01628250|O2|Outcome|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
94390|NCT01628250|O1|Outcome|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
94391|NCT01628250|E2|Reported Event|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
94392|NCT01628250|E1|Reported Event|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
94393|NCT01628042|B5|Baseline|Total|Total of all reporting groups
94394|NCT01628042|B4|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94395|NCT01628042|B3|Baseline|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94396|NCT01628042|B2|Baseline|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94397|NCT01628042|B1|Baseline|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94398|NCT01628042|P4|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94399|NCT01628042|P3|Participant Flow|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94400|NCT01628042|P2|Participant Flow|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94401|NCT01628042|P1|Participant Flow|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94402|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94403|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94404|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94405|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94406|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94407|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94408|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94409|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94410|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94411|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94412|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94413|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94414|NCT01628042|E4|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
94415|NCT01628042|E3|Reported Event|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94416|NCT01628042|E2|Reported Event|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94417|NCT01628042|E1|Reported Event|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
94418|NCT01627860|B3|Baseline|Total|Total of all reporting groups
94419|NCT01627860|B2|Baseline|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94420|NCT01627860|B1|Baseline|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94451|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94452|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94786|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94421|NCT01627860|P2|Participant Flow|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94422|NCT01627860|P1|Participant Flow|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94423|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94424|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94425|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94426|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94427|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94428|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94429|NCT01627860|E2|Reported Event|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94430|NCT01627860|E1|Reported Event|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
94431|NCT01627782|B5|Baseline|Total|Total of all reporting groups
94432|NCT01627782|B4|Baseline|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94433|NCT01627782|B3|Baseline|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94434|NCT01627782|B2|Baseline|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94435|NCT01627782|B1|Baseline|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94436|NCT01627782|P4|Participant Flow|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94437|NCT01627782|P3|Participant Flow|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94438|NCT01627782|P2|Participant Flow|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94439|NCT01627782|P1|Participant Flow|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94440|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94441|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94442|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94443|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94444|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94445|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94446|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94447|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94448|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94453|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94454|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94455|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94456|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94457|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94458|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94459|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94460|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94461|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94462|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94463|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94464|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94465|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94466|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94467|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94468|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94469|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94470|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94471|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94472|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94473|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94474|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94475|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94476|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94477|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94478|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94479|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94480|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94481|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94482|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94483|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94484|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94485|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94486|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94487|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94488|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94489|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94490|NCT01627782|E4|Reported Event|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
94491|NCT01627782|E3|Reported Event|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
94492|NCT01627782|E2|Reported Event|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
94493|NCT01627782|E1|Reported Event|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
94494|NCT01627561|B3|Baseline|Total|Total of all reporting groups
94495|NCT01627561|B2|Baseline|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94496|NCT01627561|B1|Baseline|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94497|NCT01627561|P2|Participant Flow|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94498|NCT01627561|P1|Participant Flow|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94499|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94500|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94501|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94502|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94503|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94504|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94505|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94506|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94507|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94508|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94509|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94510|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94511|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94512|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94513|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94514|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94515|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94516|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94517|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94518|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94519|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94520|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94521|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94522|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94523|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94524|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94525|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94526|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94527|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94528|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94529|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94530|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94531|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94532|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94533|NCT01627561|E2|Reported Event|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
94534|NCT01627561|E1|Reported Event|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
94535|NCT01627340|B3|Baseline|Total|Total of all reporting groups
94536|NCT01627340|B2|Baseline|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94537|NCT01627340|B1|Baseline|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94538|NCT01627340|P2|Participant Flow|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94539|NCT01627340|P1|Participant Flow|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94540|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94572|NCT01627249|P2|Participant Flow|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94541|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94542|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94543|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94544|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94545|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94546|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94547|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94548|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94549|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94550|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94551|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94552|NCT01627340|E2|Reported Event|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
94553|NCT01627340|E1|Reported Event|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
94554|NCT01627327|B3|Baseline|Total|Total of all reporting groups
94555|NCT01627327|B2|Baseline|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94556|NCT01627327|B1|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94557|NCT01627327|P2|Participant Flow|TIO 18 µg OD|Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94558|NCT01627327|P1|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94559|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94560|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94561|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94562|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94563|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94564|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94565|NCT01627327|E2|Reported Event|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
94566|NCT01627327|E1|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
94567|NCT01627249|B4|Baseline|Total|Total of all reporting groups
94568|NCT01627249|B3|Baseline|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94569|NCT01627249|B2|Baseline|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94570|NCT01627249|B1|Baseline|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94571|NCT01627249|P3|Participant Flow|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94787|NCT01626118|O4|Outcome|Placebo|Placebo Group
94573|NCT01627249|P1|Participant Flow|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94574|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94575|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94576|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94577|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94578|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94579|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94580|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94581|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94582|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94583|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94584|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94585|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94586|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94587|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94588|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94589|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94590|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94591|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94592|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94593|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94594|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94595|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94596|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94597|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94598|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94599|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94600|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94601|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
94602|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94603|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94604|NCT01627249|E3|Reported Event|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94605|NCT01627249|E2|Reported Event|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
94606|NCT01627249|E1|Reported Event|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
94607|NCT01627002|B3|Baseline|Total|Total of all reporting groups
94608|NCT01627002|B2|Baseline|Part B|
94609|NCT01627002|B1|Baseline|Part A|
94610|NCT01627002|P9|Participant Flow|Part B Placebo|Placebo was administered 30 minutes after lipopolysaccharide challenge
94611|NCT01627002|P8|Participant Flow|Part B PA401 3.0 mg|PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge
94612|NCT01627002|P7|Participant Flow|Part B PA401 1.0 mg|PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge
94613|NCT01627002|P6|Participant Flow|Part A Placebo|
94614|NCT01627002|P5|Participant Flow|Part A PA401 10 mg|
94615|NCT01627002|P4|Participant Flow|Part A PA401 3.0 mg|
94616|NCT01627002|P3|Participant Flow|Part A PA401 1.0 mg|
94617|NCT01627002|P2|Participant Flow|Part A PA401 0.3 mg|
94618|NCT01627002|P1|Participant Flow|Part A PA401 0.1 mg|
94619|NCT01627002|O3|Outcome|Part B Placebo|
94620|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
94621|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
94622|NCT01627002|O3|Outcome|Part B Placebo|
94623|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
94624|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
94625|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
94626|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
94627|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
94628|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
94629|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
94630|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
94631|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
94632|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
94633|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
94634|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
94635|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
94636|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
94637|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
94638|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
94639|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
94640|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
94641|NCT01627002|O9|Outcome|Part B Placebo|
94642|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
94643|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
94644|NCT01627002|O6|Outcome|Part A Placebo|
94645|NCT01627002|O5|Outcome|Part A PA401 10 mg|
94646|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
94647|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
94648|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
94649|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
94650|NCT01627002|O9|Outcome|Part B Placebo|
94651|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
94652|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
94653|NCT01627002|O6|Outcome|Part A Placebo|
94654|NCT01627002|O5|Outcome|Part A PA401 10 mg|
94655|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
94656|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
94657|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
94658|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
94659|NCT01627002|E9|Reported Event|Part B Placebo|
94660|NCT01627002|E8|Reported Event|Part B PA401 3.0 mg|
94661|NCT01627002|E7|Reported Event|Part B PA401 1.0 mg|
94662|NCT01627002|E6|Reported Event|Part A Placebo|
94663|NCT01627002|E5|Reported Event|Part A PA401 10 mg|
94664|NCT01627002|E4|Reported Event|Part A PA401 3.0 mg|
94665|NCT01627002|E3|Reported Event|Part A PA401 1.0 mg|
94666|NCT01627002|E2|Reported Event|Part A PA401 0.3 mg|
94667|NCT01627002|E1|Reported Event|Part A PA401 0.1 mg|
94668|NCT01626820|B3|Baseline|Total|Total of all reporting groups
94669|NCT01626820|B2|Baseline|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94670|NCT01626820|B1|Baseline|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94671|NCT01626820|P2|Participant Flow|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
94672|NCT01626820|P1|Participant Flow|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94673|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94674|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94675|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94676|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94677|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94678|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94679|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94680|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94681|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94723|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
94682|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94683|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94684|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94685|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94686|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94687|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94688|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94689|NCT01626820|E2|Reported Event|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
94690|NCT01626820|E1|Reported Event|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
94691|NCT01626690|B3|Baseline|Total|Total of all reporting groups
94692|NCT01626690|B2|Baseline|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94693|NCT01626690|B1|Baseline|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94694|NCT01626690|P2|Participant Flow|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94695|NCT01626690|P1|Participant Flow|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94696|NCT01626690|O2|Outcome|SpotOn (3M) Temperature Readings.|Patient temperature at time of incision as measured by SpotOn (3M) temperature monitoring system.
94697|NCT01626690|O1|Outcome|Temporal Artery Thermometer|Patient temperature at time of incision as measured by temporal artery thermometer.
94698|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94699|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94700|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94701|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94702|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94703|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94704|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94705|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94706|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94707|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94708|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94709|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94710|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94711|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94712|NCT01626690|E2|Reported Event|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
94713|NCT01626690|E1|Reported Event|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
94714|NCT01626456|B3|Baseline|Total|Total of all reporting groups
94715|NCT01626456|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
94716|NCT01626456|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
94717|NCT01626456|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
94718|NCT01626456|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
94719|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
94720|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
94721|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
94722|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
94724|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
94725|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
94726|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
94727|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
94728|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
94729|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study.
94730|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in the base study and the current study.
94731|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
94732|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in the base study and in the current study.
94733|NCT01626456|O1|Outcome|PBO-440 mg|Subjects who received placebo in the base study and low dose in the current study
94734|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
94735|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
94736|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
94737|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
94738|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
94739|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
94740|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
94741|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
94742|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
94743|NCT01626456|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
94744|NCT01626456|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
94745|NCT01626391|B3|Baseline|Total|Total of all reporting groups
94746|NCT01626391|B2|Baseline|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
94747|NCT01626391|B1|Baseline|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
94748|NCT01626391|P2|Participant Flow|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
94749|NCT01626391|P1|Participant Flow|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
94750|NCT01626391|O2|Outcome|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
94751|NCT01626391|O1|Outcome|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
94752|NCT01626391|E2|Reported Event|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
94753|NCT01626391|E1|Reported Event|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
94754|NCT01626118|B5|Baseline|Total|Total of all reporting groups
94755|NCT01626118|B4|Baseline|Placebo|Placebo Group
94756|NCT01626118|B3|Baseline|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94757|NCT01626118|B2|Baseline|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94758|NCT01626118|B1|Baseline|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94759|NCT01626118|P4|Participant Flow|Placebo|Placebo Group
94760|NCT01626118|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94761|NCT01626118|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94762|NCT01626118|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94763|NCT01626118|O4|Outcome|Placebo|Placebo Group
94764|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94765|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94766|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94767|NCT01626118|O4|Outcome|Placebo|Placebo Group
94768|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94769|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94770|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94771|NCT01626118|O4|Outcome|Placebo|Placebo Group
94772|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94773|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94774|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94775|NCT01626118|O4|Outcome|Placebo|Placebo Group
94776|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94777|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94778|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94779|NCT01626118|O4|Outcome|Placebo|Placebo Group
94780|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94781|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94782|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94783|NCT01626118|O4|Outcome|Placebo|Placebo Group
94784|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94785|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94788|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94789|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94790|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94791|NCT01626118|O4|Outcome|Placebo|Placebo Group
94792|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94793|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94794|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94795|NCT01626118|E4|Reported Event|Placebo|Placebo Group
94796|NCT01626118|E3|Reported Event|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
94797|NCT01626118|E2|Reported Event|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
94798|NCT01626118|E1|Reported Event|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
94799|NCT01626092|B1|Baseline|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
94800|NCT01626092|P1|Participant Flow|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
94801|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
94802|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
94803|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
94804|NCT01626092|E1|Reported Event|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
94805|NCT01625910|B3|Baseline|Total|Total of all reporting groups
94971|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
94806|NCT01625910|B2|Baseline|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
94807|NCT01625910|B1|Baseline|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
94808|NCT01625910|P2|Participant Flow|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
94809|NCT01625910|P1|Participant Flow|Intervention - Behavioral Counseling|The intervention group received management patterned after the
94810|NCT01625910|O2|Outcome|Control|Change in cans of sugar sweetened beverages per day
94811|NCT01625910|O1|Outcome|Intervention Group|"The survey done at baseline and follow-up asked about daily cans of sugar-sweetened beverages.~Estimate is for Change in cans of sugar sweetened beverages per day"
94812|NCT01625910|O2|Outcome|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
94813|NCT01625910|O1|Outcome|Intervention - Behavioral Counseling|The intervention group received management patterned after the
94814|NCT01625910|E2|Reported Event|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
94815|NCT01625910|E1|Reported Event|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
94816|NCT01625845|B3|Baseline|Total|Total of all reporting groups
94817|NCT01625845|B2|Baseline|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94818|NCT01625845|B1|Baseline|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94819|NCT01625845|P2|Participant Flow|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94820|NCT01625845|P1|Participant Flow|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94821|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94822|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94823|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94840|NCT01625689|P2|Participant Flow|Placebo|Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94824|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94825|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94826|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94827|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94828|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94829|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94830|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94831|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94832|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94833|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94834|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94835|NCT01625845|E2|Reported Event|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94836|NCT01625845|E1|Reported Event|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
94837|NCT01625689|B3|Baseline|Total|Total of all reporting groups
94838|NCT01625689|B2|Baseline|Placebo|Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94839|NCT01625689|B1|Baseline|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94841|NCT01625689|P1|Participant Flow|Serum Institute of India, Ltd. (SIIL) LAIV|The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94842|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94843|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94844|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94845|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94846|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94847|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94848|NCT01625689|E2|Reported Event|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
94849|NCT01625689|E1|Reported Event|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
94850|NCT01625507|B1|Baseline|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008"
94851|NCT01625507|P1|Participant Flow|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
94852|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94853|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94854|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94855|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94856|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94857|NCT01625507|O1|Outcome|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
94858|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94859|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94860|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94861|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
94862|NCT01625507|E1|Reported Event|All Participants|T2D diabetes patients
94863|NCT01625377|B3|Baseline|Total|Total of all reporting groups
94864|NCT01625377|B2|Baseline|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94865|NCT01625377|B1|Baseline|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94866|NCT01625377|P2|Participant Flow|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94867|NCT01625377|P1|Participant Flow|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94868|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94869|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94870|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94871|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94872|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94873|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94874|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94875|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94876|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94877|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94878|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94879|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94880|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94881|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94882|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94883|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94905|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94972|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
94884|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94885|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94886|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94887|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94888|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94889|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94890|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94891|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94892|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94893|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94894|NCT01625377|E2|Reported Event|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
94895|NCT01625377|E1|Reported Event|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
94896|NCT01625338|B4|Baseline|Total|Total of all reporting groups
94897|NCT01625338|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94898|NCT01625338|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94899|NCT01625338|B1|Baseline|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94900|NCT01625338|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
94901|NCT01625338|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94902|NCT01625338|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94903|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94904|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94906|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94907|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94908|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94909|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94910|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94911|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94912|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94913|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94914|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94915|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94916|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94917|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94918|NCT01625338|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
94919|NCT01625338|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
94920|NCT01625338|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
94921|NCT01625221|B1|Baseline|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
94922|NCT01625221|P1|Participant Flow|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
94923|NCT01625221|O1|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
94924|NCT01625221|E1|Reported Event|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
94925|NCT01625169|B1|Baseline|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.~There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum"
94926|NCT01625169|P1|Participant Flow|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94927|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94928|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94929|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94930|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94931|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94968|NCT01624467|P1|Participant Flow|Necitumumab|800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
94932|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94933|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94934|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94935|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94936|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94937|NCT01625169|E1|Reported Event|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
94938|NCT01624948|B3|Baseline|Total|Total of all reporting groups
94939|NCT01624948|B2|Baseline|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94940|NCT01624948|B1|Baseline|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94941|NCT01624948|P2|Participant Flow|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94942|NCT01624948|P1|Participant Flow|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94943|NCT01624948|O2|Outcome|No Rejection|No biopsy-proven rejection episode
94944|NCT01624948|O1|Outcome|Rejection|Any biopsy-proven rejection episode
94945|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94946|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94947|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94969|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94970|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94948|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94949|NCT01624948|O2|Outcome|Failed to Reach Primary Endpoint|
94950|NCT01624948|O1|Outcome|Reached Primary Endpoint|>50% reduction of BKV viruria and/or clearance of BKV viremia
94951|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94952|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94953|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
94954|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
94955|NCT01624948|E2|Reported Event|Standard of Care: 50% Reduction of MPA|Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
94956|NCT01624948|E1|Reported Event|Everolimus+Tacrolimus/Prednisone|Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
94957|NCT01624740|B3|Baseline|Total|Total of all reporting groups
94958|NCT01624740|B2|Baseline|High Rate Followed By Low Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
94959|NCT01624740|B1|Baseline|Low Rate Followed By High Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
94960|NCT01624740|P2|Participant Flow|High Rate Followed By Low Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
94961|NCT01624740|P1|Participant Flow|Low Rate Followed By High Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
94962|NCT01624740|O2|Outcome|High Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
94963|NCT01624740|O1|Outcome|Low Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 2 Hz as either a first or second intervention.
94964|NCT01624740|E3|Reported Event|High Frequency Stimulation|Stimulation was given at 1200 Hz.
94965|NCT01624740|E2|Reported Event|Low Frequency Stimulation|Stimulation was given at 2 Hz.
94966|NCT01624740|E1|Reported Event|Trial Lead Insertion|All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
94967|NCT01624467|B1|Baseline|Necitumumab|800 mg necitumumab, administered once per week IV
94973|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
94974|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
94975|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94976|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94977|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94978|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
94979|NCT01624467|E1|Reported Event|Necitumumab|800 mg necitumumab, administered once per week as an intravenous infusion (IV)
94980|NCT01624350|B1|Baseline|Permacol Collagen Paste|
94981|NCT01624350|P1|Participant Flow|Permacol Collagen Paste|
94982|NCT01624350|O5|Outcome|Permacol Collagen Paste - 12 Month Post-op|
94983|NCT01624350|O4|Outcome|Permacol Collagen Paste - 6 Month Post-op|
94984|NCT01624350|O3|Outcome|Permacol Collagen Paste - 3 Month Post-op|
94985|NCT01624350|O2|Outcome|Permacol Collagen Paste - 1 Month Post-op|
94986|NCT01624350|O1|Outcome|Baseline|
94987|NCT01624350|O2|Outcome|Last Visit|
94988|NCT01624350|O1|Outcome|First Visit|
94989|NCT01624350|O3|Outcome|Permacol Collagen Paste - 12 Month Post-op|
94990|NCT01624350|O2|Outcome|Permacol Collagen Paste - 6 Month Post-op|
94991|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Post-op|
94992|NCT01624350|O4|Outcome|Permacol Collagen Paste - 12 Month Post-op|
94993|NCT01624350|O3|Outcome|Permacol Collagen Paste - 6 Month Post-op|
94994|NCT01624350|O2|Outcome|Permacol Collagen Paste - 3 Month Post-op|
94995|NCT01624350|O1|Outcome|Baseline - Pre-operatively|
94996|NCT01624350|O2|Outcome|Permacol Collagen Paste - 12 Month Follow up|
94997|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Follow up|
94998|NCT01624350|O1|Outcome|Permacol Collagen Paste|
94999|NCT01624350|E1|Reported Event|Permacol Collagen Paste|
95000|NCT01624259|B3|Baseline|Total|Total of all reporting groups
95001|NCT01624259|B2|Baseline|Liraglutide|"Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95002|NCT01624259|B1|Baseline|LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95003|NCT01624259|P2|Participant Flow|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95004|NCT01624259|P1|Participant Flow|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95005|NCT01624259|O2|Outcome|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95006|NCT01624259|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
95007|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95008|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95009|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95010|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95011|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95012|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95013|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95014|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95015|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95016|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95017|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95018|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95019|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95020|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95021|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95022|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95023|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95024|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95025|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95026|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95027|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95028|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95029|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95030|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95031|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95032|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95033|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95034|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95035|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95036|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95037|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95038|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95039|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95040|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95041|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95042|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95043|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95044|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95045|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95046|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95047|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95048|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95049|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95050|NCT01624259|E2|Reported Event|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95051|NCT01624259|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
95091|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95335|NCT01621672|P1|Participant Flow|Revlimid|Revlimid: 10 mg/day in the morning same time each day
95052|NCT01624233|B1|Baseline|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95053|NCT01624233|P1|Participant Flow|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).~Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
95054|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95055|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95056|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95057|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95058|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95059|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95060|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95061|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95062|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95063|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95064|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95092|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95065|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95066|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95067|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95068|NCT01624233|E1|Reported Event|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
95069|NCT01624168|B4|Baseline|Total|Total of all reporting groups
95070|NCT01624168|B3|Baseline|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95071|NCT01624168|B2|Baseline|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95072|NCT01624168|B1|Baseline|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95073|NCT01624168|P3|Participant Flow|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95074|NCT01624168|P2|Participant Flow|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95075|NCT01624168|P1|Participant Flow|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95076|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95077|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95078|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95079|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95080|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95081|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95082|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95083|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95084|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95085|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95086|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95087|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95088|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95089|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95090|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95093|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95336|NCT01621672|O2|Outcome|Observation|No treatment
95094|NCT01624168|E3|Reported Event|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
95095|NCT01624168|E2|Reported Event|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
95096|NCT01624168|E1|Reported Event|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
95097|NCT01623869|B1|Baseline|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95098|NCT01623869|P1|Participant Flow|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95099|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95100|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95101|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95102|NCT01623869|E1|Reported Event|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
95103|NCT01623830|B3|Baseline|Total|Total of all reporting groups
95104|NCT01623830|B2|Baseline|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95105|NCT01623830|B1|Baseline|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95106|NCT01623830|P2|Participant Flow|Neutral Cue + VRE|"VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
95107|NCT01623830|P1|Participant Flow|Reactivation + VRE|"Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
95108|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95109|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95110|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95111|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95112|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95113|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95114|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95115|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95116|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95117|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95118|NCT01623830|E2|Reported Event|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95156|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95119|NCT01623830|E1|Reported Event|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
95120|NCT01623479|B1|Baseline|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95121|NCT01623479|P1|Participant Flow|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95122|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95123|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95124|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95125|NCT01623479|E1|Reported Event|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
95126|NCT01623323|B1|Baseline|OPN-375|OPN-375 400 mcg/twice daily
95127|NCT01623323|P1|Participant Flow|OPN-375|OPN-375 400 mcg/twice daily
95128|NCT01623323|O1|Outcome|OPN-375|OPN-375 400 mcg/twice daily
95129|NCT01623323|E1|Reported Event|OPN-375|OPN-375 400 mcg/twice daily
95130|NCT01623154|B1|Baseline|BreathTek UBT|Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device.
95131|NCT01623154|P1|Participant Flow|Urea Hydrolysis Rate (UHR)|"Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300~Same patients will be tested on both the POCone and UBiT-IR300"
95132|NCT01623154|O2|Outcome|POCone|This is the device being tested and compared to the FDA approved device.
95133|NCT01623154|O1|Outcome|UBiT-IR300|This is the FDA approved device.
95134|NCT01623154|O1|Outcome|Urea Hydrolysis Rate (UHR) Values|Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
95135|NCT01623154|E1|Reported Event|Pranactin Citric Solution|At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy.
95136|NCT01623115|B3|Baseline|Total|Total of all reporting groups
95137|NCT01623115|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95138|NCT01623115|B1|Baseline|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95139|NCT01623115|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95140|NCT01623115|P1|Participant Flow|Placebo|Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
95141|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95142|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95143|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95144|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95145|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95146|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95147|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95148|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95149|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95150|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95151|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95152|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95153|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95154|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95155|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95157|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95158|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95159|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95160|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95161|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95162|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95163|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95164|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95165|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95166|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95167|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95168|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95169|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95170|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95171|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95172|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95173|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95174|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95175|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95176|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95177|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95178|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95179|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95180|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95181|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95182|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95183|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95184|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95185|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95186|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95187|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95188|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95189|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95190|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95191|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95192|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95193|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95194|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95221|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of AE assessment
95195|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
95196|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95197|NCT01623115|E2|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks).
95198|NCT01623115|E1|Reported Event|Placebo|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks).
95199|NCT01623050|B1|Baseline|SinuSys Dilation System|"Maxillary Sinus Dilation~SinuSys Dilation System: Sinuplasty"
95200|NCT01623050|P1|Participant Flow|SinuSys Dilation System|Maxillary Sinus Dilation
95201|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
95202|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
95203|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
95204|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
95205|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
95206|NCT01623050|E1|Reported Event|SinuSys Dilation System|Maxillary Sinus Dilation
95207|NCT01622673|B7|Baseline|Total|Total of all reporting groups
95208|NCT01622673|B6|Baseline|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95209|NCT01622673|B5|Baseline|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95210|NCT01622673|B4|Baseline|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95211|NCT01622673|B3|Baseline|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95212|NCT01622673|B2|Baseline|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95213|NCT01622673|B1|Baseline|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
95214|NCT01622673|P6|Participant Flow|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95215|NCT01622673|P5|Participant Flow|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95216|NCT01622673|P4|Participant Flow|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95217|NCT01622673|P3|Participant Flow|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95218|NCT01622673|P2|Participant Flow|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
95219|NCT01622673|P1|Participant Flow|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
95220|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of AE assessment
95222|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of AE assessment
95223|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of AE assessment
95224|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95225|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
95226|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
95227|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
95228|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
95229|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95230|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
95231|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
95232|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95233|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
95234|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
95235|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95236|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
95237|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
95238|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95239|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
95240|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
95241|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95242|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
95243|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
95244|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95245|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
95246|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
95247|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
95248|NCT01622673|E5|Reported Event|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
95249|NCT01622673|E4|Reported Event|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
95250|NCT01622673|E3|Reported Event|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
95251|NCT01622673|E2|Reported Event|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
95252|NCT01622673|E1|Reported Event|Raltegravir|Raltegravir 400 mg every 12 hours
95253|NCT01622296|B1|Baseline|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
95254|NCT01622296|P2|Participant Flow|Buffered Lidocaine First, Then Lidocaine|buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
95255|NCT01622296|P1|Participant Flow|Lidocaine First, Then Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
95256|NCT01622296|O2|Outcome|Buffered Lidocaine|2% buffered lidocaine with 1:100,000 ppm epinephrine
95257|NCT01622296|O1|Outcome|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
95258|NCT01622296|E1|Reported Event|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
95259|NCT01622257|B4|Baseline|Total|Total of all reporting groups
95260|NCT01622257|B3|Baseline|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95261|NCT01622257|B2|Baseline|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95262|NCT01622257|B1|Baseline|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95263|NCT01622257|P3|Participant Flow|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95264|NCT01622257|P2|Participant Flow|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95265|NCT01622257|P1|Participant Flow|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95266|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95267|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95268|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95269|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95270|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95271|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95272|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95273|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95274|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95275|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95276|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95277|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95278|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95279|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95280|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95281|NCT01622257|E3|Reported Event|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
95282|NCT01622257|E2|Reported Event|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
95283|NCT01622257|E1|Reported Event|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
95284|NCT01622231|B1|Baseline|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95285|NCT01622231|P1|Participant Flow|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95286|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95287|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95288|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95289|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95290|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95291|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95292|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95293|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95294|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95295|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95296|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95297|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95298|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95299|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95300|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95301|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95302|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95303|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95304|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95305|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95306|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95307|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95308|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95309|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95310|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95311|NCT01622231|E1|Reported Event|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
95312|NCT01621776|B4|Baseline|Total|Total of all reporting groups
95313|NCT01621776|B3|Baseline|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95314|NCT01621776|B2|Baseline|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95315|NCT01621776|B1|Baseline|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95316|NCT01621776|P3|Participant Flow|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95317|NCT01621776|P2|Participant Flow|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95318|NCT01621776|P1|Participant Flow|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95319|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95320|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95321|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95322|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95323|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95324|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95325|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95326|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95327|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95328|NCT01621776|E3|Reported Event|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
95329|NCT01621776|E2|Reported Event|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95330|NCT01621776|E1|Reported Event|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
95331|NCT01621672|B3|Baseline|Total|Total of all reporting groups
95332|NCT01621672|B2|Baseline|Observation|No treatment
95333|NCT01621672|B1|Baseline|Revlimid|Revlimid: 10 mg/day in the morning same time each day
95334|NCT01621672|P2|Participant Flow|Observation|No treatment
95337|NCT01621672|O1|Outcome|Revlimid|Revlimid: 10 mg/day in the morning same time each day
95338|NCT01621672|E2|Reported Event|Observation|No treatment
95339|NCT01621672|E1|Reported Event|Revlimid|Revlimid: 10 mg/day in the morning same time each day
95340|NCT01621633|B5|Baseline|Total|Total of all reporting groups
95341|NCT01621633|B4|Baseline|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95342|NCT01621633|B3|Baseline|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95343|NCT01621633|B2|Baseline|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95344|NCT01621633|B1|Baseline|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95345|NCT01621633|P4|Participant Flow|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95346|NCT01621633|P3|Participant Flow|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95347|NCT01621633|P2|Participant Flow|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95348|NCT01621633|P1|Participant Flow|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95349|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95350|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95351|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95352|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95353|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95354|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95355|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95356|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95357|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95358|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95359|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95360|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95361|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95362|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95363|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95364|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95365|NCT01621633|E4|Reported Event|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
95366|NCT01621633|E3|Reported Event|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
95367|NCT01621633|E2|Reported Event|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
95368|NCT01621633|E1|Reported Event|Moderate Hepatic Impaired Patients|Moderate hepatic impaired patients
95369|NCT01621191|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
95370|NCT01621191|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
97241|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
95371|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95372|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95373|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95374|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95375|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95376|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95377|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
95378|NCT01621191|O1|Outcome|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
95379|NCT01621191|E1|Reported Event|60 mg Duloxetine|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
95380|NCT01621126|B1|Baseline|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
95381|NCT01621126|P1|Participant Flow|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
95382|NCT01621126|O1|Outcome|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
95383|NCT01621126|E1|Reported Event|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
95384|NCT01621009|B5|Baseline|Total|Total of all reporting groups
95385|NCT01621009|B4|Baseline|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
95386|NCT01621009|B3|Baseline|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
95387|NCT01621009|B2|Baseline|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
97361|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
95388|NCT01621009|B1|Baseline|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
95389|NCT01621009|P4|Participant Flow|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
95390|NCT01621009|P3|Participant Flow|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
95391|NCT01621009|P2|Participant Flow|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
95392|NCT01621009|P1|Participant Flow|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
95393|NCT01621009|O4|Outcome|Placebo, No Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~No cessation counseling, medication management and assessment only."
95394|NCT01621009|O3|Outcome|Placebo + Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
95395|NCT01621009|O2|Outcome|Bupropion, No Counseling|Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
95396|NCT01621009|O1|Outcome|Bupropion + Counseling|"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
95397|NCT01621009|E2|Reported Event|Active Medication|Pre-quit – 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
95398|NCT01621009|E1|Reported Event|Placebo Medication|Medications: Pre-quit – one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.
95399|NCT01620489|B3|Baseline|Total|Total of all reporting groups
95400|NCT01620489|B2|Baseline|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95401|NCT01620489|B1|Baseline|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95402|NCT01620489|P2|Participant Flow|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95403|NCT01620489|P1|Participant Flow|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95404|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95405|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95406|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95407|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95408|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95435|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95409|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95410|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95411|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95412|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95413|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95414|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95415|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95416|NCT01620489|E2|Reported Event|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95417|NCT01620489|E1|Reported Event|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
95418|NCT01620138|B3|Baseline|Total|Total of all reporting groups
95419|NCT01620138|B2|Baseline|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95420|NCT01620138|B1|Baseline|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95421|NCT01620138|P2|Participant Flow|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95525|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95422|NCT01620138|P1|Participant Flow|Pasireotide|"Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months."
95423|NCT01620138|O2|Outcome|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95424|NCT01620138|O1|Outcome|Pasireotide|"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95425|NCT01620138|E2|Reported Event|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95426|NCT01620138|E1|Reported Event|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed immediately before and six months after the onset of pasireotide . The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
95427|NCT01620086|B3|Baseline|Total|Total of all reporting groups
95428|NCT01620086|B2|Baseline|Controls|These subjects are normal controls without schizophrenia who get stimulation over the vertex.
95429|NCT01620086|B1|Baseline|Patients|Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
95430|NCT01620086|P3|Participant Flow|Patients: Baseline, Control Site, 10Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
95431|NCT01620086|P2|Participant Flow|Patients: Baseline, Control Site, & 1Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
95432|NCT01620086|P1|Participant Flow|Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex|These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
95433|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95434|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95436|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95437|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95438|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95439|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95440|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95441|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95442|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95443|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95444|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95445|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
95446|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95447|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
95448|NCT01620086|E2|Reported Event|Controls|These subjects are normal controls without schizophrenia.
95449|NCT01620086|E1|Reported Event|Patients|These are schizophrenic patients who meet entry criteria for the study.
95450|NCT01620060|B1|Baseline|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95451|NCT01620060|P1|Participant Flow|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95452|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95453|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95454|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95455|NCT01620060|E1|Reported Event|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
95456|NCT01620047|B4|Baseline|Total|Total of all reporting groups
95457|NCT01620047|B3|Baseline|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95458|NCT01620047|B2|Baseline|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95459|NCT01620047|B1|Baseline|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95460|NCT01620047|P3|Participant Flow|Intravenous Fentanyl|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95461|NCT01620047|P2|Participant Flow|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95462|NCT01620047|P1|Participant Flow|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95463|NCT01620047|O3|Outcome|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95464|NCT01620047|O2|Outcome|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95465|NCT01620047|O1|Outcome|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95466|NCT01620047|E3|Reported Event|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95467|NCT01620047|E2|Reported Event|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95468|NCT01620047|E1|Reported Event|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
95469|NCT01619878|B1|Baseline|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95470|NCT01619878|P1|Participant Flow|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95471|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95472|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95473|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95474|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95475|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95476|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95477|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95478|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95479|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95480|NCT01619878|E1|Reported Event|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
95481|NCT01619800|B3|Baseline|Total|Total of all reporting groups
95482|NCT01619800|B2|Baseline|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
95483|NCT01619800|B1|Baseline|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
95484|NCT01619800|P2|Participant Flow|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
95485|NCT01619800|P1|Participant Flow|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
95486|NCT01619800|O2|Outcome|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
95487|NCT01619800|O1|Outcome|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
95488|NCT01619800|E2|Reported Event|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
95489|NCT01619800|E1|Reported Event|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
95490|NCT01619787|B3|Baseline|Total|Total of all reporting groups
95491|NCT01619787|B2|Baseline|Overweight/Obese Participants|"Participants whose baseline BMI is greater than or equal to 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
95524|NCT01619059|P1|Participant Flow|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95492|NCT01619787|B1|Baseline|Lean Participants|"Participants whose baseline BMI is less than 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
95493|NCT01619787|P1|Participant Flow|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
95494|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
95495|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
95496|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
95497|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
95498|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
95499|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
95500|NCT01619787|E1|Reported Event|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy, along with the Three Factor Eating Questionnaire were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
95501|NCT01619774|B1|Baseline|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95502|NCT01619774|P1|Participant Flow|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95503|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95504|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95505|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95506|NCT01619774|E1|Reported Event|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
95507|NCT01619579|B3|Baseline|Total|Total of all reporting groups
95508|NCT01619579|B2|Baseline|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
95509|NCT01619579|B1|Baseline|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
95510|NCT01619579|P2|Participant Flow|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
95511|NCT01619579|P1|Participant Flow|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.
95512|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
95513|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
95514|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
95515|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
95516|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
95517|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
95518|NCT01619579|E2|Reported Event|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
95519|NCT01619579|E1|Reported Event|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
95520|NCT01619059|B3|Baseline|Total|Total of all reporting groups
95521|NCT01619059|B2|Baseline|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95522|NCT01619059|B1|Baseline|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95523|NCT01619059|P2|Participant Flow|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95526|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95527|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95528|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95529|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95530|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95531|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95532|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95533|NCT01619059|E2|Reported Event|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95534|NCT01619059|E1|Reported Event|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
95535|NCT01618968|B5|Baseline|Total|Total of all reporting groups
95536|NCT01618968|B4|Baseline|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95537|NCT01618968|B3|Baseline|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95538|NCT01618968|B2|Baseline|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95539|NCT01618968|B1|Baseline|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95540|NCT01618968|P4|Participant Flow|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95541|NCT01618968|P3|Participant Flow|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95542|NCT01618968|P2|Participant Flow|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95543|NCT01618968|P1|Participant Flow|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95544|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
95545|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
95546|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
95547|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
95548|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
95549|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
95550|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
95551|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
95552|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
95553|NCT01618968|E4|Reported Event|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95554|NCT01618968|E3|Reported Event|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95555|NCT01618968|E2|Reported Event|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95556|NCT01618968|E1|Reported Event|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
95557|NCT01618955|B5|Baseline|Total|Total of all reporting groups
95558|NCT01618955|B4|Baseline|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95559|NCT01618955|B3|Baseline|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95560|NCT01618955|B2|Baseline|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95561|NCT01618955|B1|Baseline|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95562|NCT01618955|P4|Participant Flow|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95563|NCT01618955|P3|Participant Flow|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95564|NCT01618955|P2|Participant Flow|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95565|NCT01618955|P1|Participant Flow|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
95566|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95567|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95568|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95569|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95570|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95571|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95572|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95573|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95574|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95575|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95576|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95577|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95578|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95579|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95580|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95581|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95582|NCT01618955|E4|Reported Event|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95583|NCT01618955|E3|Reported Event|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95584|NCT01618955|E2|Reported Event|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95585|NCT01618955|E1|Reported Event|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
95586|NCT01618942|B3|Baseline|Total|Total of all reporting groups
95587|NCT01618942|B2|Baseline|Female Subjects|grouped by gender
95588|NCT01618942|B1|Baseline|Male Subjects|grouped by gender
95589|NCT01618942|P2|Participant Flow|Female Subjects|grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
95590|NCT01618942|P1|Participant Flow|Male Subjects|grouped by gender and applied with hand-held pressure algometer with differen
95591|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95592|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95593|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95594|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95595|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95596|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95597|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95598|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95599|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95600|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95601|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95602|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95603|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95604|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95605|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
95606|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
95607|NCT01618942|E2|Reported Event|Female Subjects|grouped by gender
95608|NCT01618942|E1|Reported Event|Male Subjects|grouped by gender
95609|NCT01618864|B1|Baseline|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
95610|NCT01618864|P1|Participant Flow|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
95611|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Evaluation of rosacea after 8 weeks of treatment.
95612|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.
95613|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
95614|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.
95615|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|GAI assessment by investigator at 8 weeks.
95616|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
95617|NCT01618864|E1|Reported Event|Treatment Group|All treated subjects were evaluated for adverse events during the study.
95618|NCT01618838|B1|Baseline|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
95643|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95619|NCT01618838|P1|Participant Flow|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
95620|NCT01618838|O1|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
95621|NCT01618838|E1|Reported Event|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
95622|NCT01618708|B3|Baseline|Total|Total of all reporting groups
95623|NCT01618708|B2|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95624|NCT01618708|B1|Baseline|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95625|NCT01618708|P2|Participant Flow|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95626|NCT01618708|P1|Participant Flow|Placebo|Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95627|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95628|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95629|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95630|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95631|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95632|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
95633|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95634|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95635|NCT01618708|E2|Reported Event|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
95636|NCT01618708|E1|Reported Event|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
95637|NCT01618669|B3|Baseline|Total|Total of all reporting groups
95638|NCT01618669|B2|Baseline|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95639|NCT01618669|B1|Baseline|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95640|NCT01618669|P2|Participant Flow|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95641|NCT01618669|P1|Participant Flow|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95642|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
98350|NCT01605877|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
95644|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95645|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95646|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95647|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95648|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95649|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95650|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95651|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95652|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95653|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95654|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95655|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95656|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95657|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95658|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95659|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95660|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95661|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95662|NCT01618669|O6|Outcome|REG Alone: MPI 2 SDS ≥ 14|Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.
95663|NCT01618669|O5|Outcome|REG Alone: MPI 2 SDS 7-13|Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.
95664|NCT01618669|O4|Outcome|REG Alone: MPI 2 SDS 0-6|Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.
95665|NCT01618669|O3|Outcome|REG APEX: MPI 2 SDS ≥ 14|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.
95666|NCT01618669|O2|Outcome|REG APEX: MPI 2 7-13|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.
95667|NCT01618669|O1|Outcome|REG APEX: MPI 2 SDS 0-6|Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.
95668|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95669|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95670|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95671|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95672|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95673|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95674|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95675|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95676|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95677|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95678|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95679|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95680|NCT01618669|E4|Reported Event|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95681|NCT01618669|E3|Reported Event|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95682|NCT01618669|E2|Reported Event|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95683|NCT01618669|E1|Reported Event|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
95684|NCT01618422|B3|Baseline|Total|Total of all reporting groups
95685|NCT01618422|B2|Baseline|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
95686|NCT01618422|B1|Baseline|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin.
95687|NCT01618422|P2|Participant Flow|DOTS Plus|"The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.~Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and"
95688|NCT01618422|P1|Participant Flow|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
95689|NCT01618422|O2|Outcome|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
98351|NCT01605877|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
95690|NCT01618422|O1|Outcome|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
95691|NCT01618422|E2|Reported Event|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
95692|NCT01618422|E1|Reported Event|DOTS Strategy|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
95693|NCT01618266|B1|Baseline|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95694|NCT01618266|P1|Participant Flow|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95695|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95696|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95697|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95698|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95699|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95700|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95701|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95702|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95703|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95704|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95705|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95706|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95707|NCT01618266|E1|Reported Event|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
95708|NCT01618240|B1|Baseline|Baseline Population|Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
95709|NCT01618240|P1|Participant Flow|Long-term Ventilated Subjects|Long-term (>10 days hours) ventilated subjects were included.
95710|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
95711|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
95712|NCT01618240|E1|Reported Event|Long-term Ventilated Subjects|30 consented long-term ventilated patients
95713|NCT01618214|B3|Baseline|Total|Total of all reporting groups
95714|NCT01618214|B2|Baseline|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95715|NCT01618214|B1|Baseline|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
98352|NCT01605877|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
95716|NCT01618214|P2|Participant Flow|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95717|NCT01618214|P1|Participant Flow|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95718|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95719|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95720|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95721|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95722|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95723|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95724|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95725|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95726|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95836|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95727|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95728|NCT01618214|E2|Reported Event|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95729|NCT01618214|E1|Reported Event|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
95730|NCT01618162|B3|Baseline|Total|Total of all reporting groups
95731|NCT01618162|B2|Baseline|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95732|NCT01618162|B1|Baseline|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95733|NCT01618162|P2|Participant Flow|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95734|NCT01618162|P1|Participant Flow|IDegLira|In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95735|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95736|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95737|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
98353|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
95738|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95739|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95740|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95741|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95742|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95743|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95744|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95745|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95746|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95747|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95748|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95749|NCT01618162|E2|Reported Event|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
95750|NCT01618162|E1|Reported Event|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
95751|NCT01618019|B3|Baseline|Total|Total of all reporting groups
95752|NCT01618019|B2|Baseline|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95753|NCT01618019|B1|Baseline|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95754|NCT01618019|P2|Participant Flow|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95755|NCT01618019|P1|Participant Flow|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95756|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95757|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95758|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95759|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95760|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95761|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95762|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95763|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95764|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95765|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95766|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95767|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95768|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95769|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95770|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95771|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95772|NCT01618019|E2|Reported Event|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
95773|NCT01618019|E1|Reported Event|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
95774|NCT01617668|B3|Baseline|Total|Total of all reporting groups
95775|NCT01617668|B2|Baseline|Paclitaxel Without LCL161|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95776|NCT01617668|B1|Baseline|Paclitaxel With LCL161|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95777|NCT01617668|P4|Participant Flow|Paclitaxel Without LCL161 (Negative Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95778|NCT01617668|P3|Participant Flow|Paclitaxel With LCL161 (Negative Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95779|NCT01617668|P2|Participant Flow|Paclitaxel Without LCL161 (Positive Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95780|NCT01617668|P1|Participant Flow|Paclitaxel With LCL161 (Positive Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95781|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
95782|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
95783|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95784|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95785|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95786|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95787|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95788|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95789|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95790|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95791|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95792|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95793|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95794|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95795|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95796|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95797|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95798|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95799|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95800|NCT01617668|O2|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
95801|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
95802|NCT01617668|O1|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
95803|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm who received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
95837|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95804|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95805|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95806|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95807|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95808|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95809|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95810|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95811|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95812|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95813|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95814|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95815|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95816|NCT01617668|E2|Reported Event|PACLITAXEL|Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95817|NCT01617668|E1|Reported Event|LCL161+PACLITAXEL|Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
95818|NCT01617655|B3|Baseline|Total|Total of all reporting groups
95819|NCT01617655|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95820|NCT01617655|B1|Baseline|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95821|NCT01617655|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95822|NCT01617655|P1|Participant Flow|Placebo Q2W|Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
95823|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95824|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95825|NCT01617655|O2|Outcome|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 78 weeks).
95826|NCT01617655|O1|Outcome|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 78 weeks).
95827|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95828|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95829|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95830|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95831|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95832|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95833|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95834|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95835|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95838|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95839|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95840|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95841|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95842|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95843|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95844|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95845|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95846|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95847|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95848|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95849|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95850|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95851|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95852|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95853|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95854|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95855|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95856|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95857|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95858|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95859|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95860|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95861|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95862|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95863|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95864|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95865|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95866|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95867|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95868|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95869|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95870|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95871|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95872|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95873|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95874|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95875|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95876|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95877|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
95878|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
95879|NCT01617655|E2|Reported Event|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks).
95880|NCT01617655|E1|Reported Event|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks).
95881|NCT01617603|B4|Baseline|Total|Total of all reporting groups
95882|NCT01617603|B3|Baseline|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95883|NCT01617603|B2|Baseline|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95884|NCT01617603|B1|Baseline|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95885|NCT01617603|P3|Participant Flow|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95932|NCT01617187|B2|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95886|NCT01617603|P2|Participant Flow|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95887|NCT01617603|P1|Participant Flow|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95888|NCT01617603|O3|Outcome|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95889|NCT01617603|O2|Outcome|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95890|NCT01617603|O1|Outcome|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95891|NCT01617603|E3|Reported Event|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95892|NCT01617603|E2|Reported Event|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95893|NCT01617603|E1|Reported Event|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
95894|NCT01617577|B3|Baseline|Total|Total of all reporting groups
95895|NCT01617577|B2|Baseline|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
95896|NCT01617577|B1|Baseline|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
95897|NCT01617577|P2|Participant Flow|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
95898|NCT01617577|P1|Participant Flow|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
95899|NCT01617577|O1|Outcome|G-CSF and Placebo|All participants received G-CSF and placebo in crossover order
95900|NCT01617577|O2|Outcome|Placebo|All participants received placebo either in the first or second phase of crossover
95901|NCT01617577|O1|Outcome|G-CSF|All participants received G-CSF either in the first or second phase of the crossover
95902|NCT01617577|E2|Reported Event|G-CSF|participants who received GCSF injecitons during first or second phase
95903|NCT01617577|E1|Reported Event|Placebo|subjects who received placebo in either phase of the study
95904|NCT01617434|B3|Baseline|Total|Total of all reporting groups
95905|NCT01617434|B2|Baseline|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95906|NCT01617434|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95907|NCT01617434|P2|Participant Flow|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95908|NCT01617434|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95909|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95910|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95911|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95912|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95913|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95914|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95915|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95916|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95917|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95918|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95933|NCT01617187|B1|Baseline|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95934|NCT01617187|P4|Participant Flow|Placebo BID|Participants were administered placebo tablets BID for 42 days
95935|NCT01617187|P3|Participant Flow|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95919|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95920|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95921|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95922|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95923|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95924|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95925|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95926|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95927|NCT01617434|E2|Reported Event|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95928|NCT01617434|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
95929|NCT01617187|B5|Baseline|Total|Total of all reporting groups
95930|NCT01617187|B4|Baseline|Placebo BID|Participants were administered placebo tablets BID for 42 days
95931|NCT01617187|B3|Baseline|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
98354|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
95936|NCT01617187|P2|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95937|NCT01617187|P1|Participant Flow|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
95938|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95939|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95940|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95941|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95942|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95943|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95944|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95945|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95946|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95947|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95948|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95949|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95950|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95951|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95952|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95953|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95954|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95955|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95956|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95957|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95958|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95959|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95960|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95961|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95962|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95963|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95964|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95965|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95966|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95967|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95968|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95969|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95970|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95971|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95972|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95973|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95974|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95975|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95976|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95977|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95978|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95979|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95980|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95981|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95982|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95983|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95984|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95985|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95986|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95987|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95988|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95989|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95990|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95991|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95992|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95993|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95994|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95995|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
95996|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
95997|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
95998|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
95999|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
96000|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
96001|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
96002|NCT01617187|E4|Reported Event|Placebo BID|Participants were administered placebo tablets BID for 42 days
96003|NCT01617187|E3|Reported Event|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
96004|NCT01617187|E2|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
96005|NCT01617187|E1|Reported Event|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
96006|NCT01617070|B1|Baseline|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96007|NCT01617070|P1|Participant Flow|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96008|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96009|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
96010|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
96011|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96012|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96013|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
96014|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
96015|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96016|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96017|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
96018|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
96019|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96020|NCT01617070|E4|Reported Event|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96021|NCT01617070|E3|Reported Event|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
96022|NCT01617070|E2|Reported Event|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
96023|NCT01617070|E1|Reported Event|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
96024|NCT01617005|B1|Baseline|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96047|NCT01616576|O3|Outcome|Experimental|Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
96671|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96025|NCT01617005|P1|Participant Flow|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96026|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96027|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96028|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96029|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96030|NCT01617005|E1|Reported Event|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
96031|NCT01616771|B1|Baseline|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
96032|NCT01616771|P1|Participant Flow|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
96033|NCT01616771|O2|Outcome|Smaller Sized GVL|The C&L grade was reassessed by smaller sized GVL, after removal of GVL selected by weight
96034|NCT01616771|O1|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
96035|NCT01616771|O2|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
96036|NCT01616771|O1|Outcome|Macintosh Laryngoscope|After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C&L grade was checked.
96037|NCT01616771|E3|Reported Event|Smaller Sized GVL|C&L grade assessment by smaller sized GVL, after removal of GVL selected by weight
96038|NCT01616771|E2|Reported Event|GVL Selected by Weight|C&L grade assessment by GVL selected by weight, after removal of Macintosh laryngoscope
96039|NCT01616771|E1|Reported Event|Macintosh Laryngoscope|C&L grade assessment by Macintosh laryngoscope, after induction of anesthesia
96040|NCT01616576|B3|Baseline|Total|Total of all reporting groups
96041|NCT01616576|B2|Baseline|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96042|NCT01616576|B1|Baseline|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96043|NCT01616576|P2|Participant Flow|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96044|NCT01616576|P1|Participant Flow|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96045|NCT01616576|O2|Outcome|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96046|NCT01616576|O1|Outcome|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96048|NCT01616576|O2|Outcome|Control|Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
96049|NCT01616576|O1|Outcome|Group A and Group B Data Pooled|Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
96050|NCT01616576|E2|Reported Event|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96051|NCT01616576|E1|Reported Event|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
96052|NCT01616459|B5|Baseline|Total|Total of all reporting groups
96053|NCT01616459|B4|Baseline|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96054|NCT01616459|B3|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96055|NCT01616459|B2|Baseline|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96056|NCT01616459|B1|Baseline|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96057|NCT01616459|P4|Participant Flow|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96058|NCT01616459|P3|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96116|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96117|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
96059|NCT01616459|P2|Participant Flow|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96060|NCT01616459|P1|Participant Flow|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96061|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96062|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96063|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96064|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96065|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96066|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96118|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96119|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96120|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
98355|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
96067|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96068|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96069|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96070|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96071|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96072|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96073|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96074|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96121|NCT01616173|E3|Reported Event|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96122|NCT01616173|E2|Reported Event|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96123|NCT01616173|E1|Reported Event|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
96124|NCT01615939|B3|Baseline|Total|Total of all reporting groups
96075|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96076|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96077|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96078|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96079|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96080|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96081|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96082|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96125|NCT01615939|B2|Baseline|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96672|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96083|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96084|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96085|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96086|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96087|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96088|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96089|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96090|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96126|NCT01615939|B1|Baseline|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96128|NCT01615939|P1|Participant Flow|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96091|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96092|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96093|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96094|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96095|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96096|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96097|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96098|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96127|NCT01615939|P2|Participant Flow|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96673|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96099|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96100|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96101|NCT01616459|E4|Reported Event|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
96102|NCT01616459|E3|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96103|NCT01616459|E2|Reported Event|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96104|NCT01616459|E1|Reported Event|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
96105|NCT01616173|B4|Baseline|Total|Total of all reporting groups
96106|NCT01616173|B3|Baseline|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96107|NCT01616173|B2|Baseline|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96108|NCT01616173|B1|Baseline|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
96109|NCT01616173|P3|Participant Flow|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96110|NCT01616173|P2|Participant Flow|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96111|NCT01616173|P1|Participant Flow|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
96112|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96113|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
96114|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
96115|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
96155|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
96129|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96130|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96131|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96132|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96133|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96134|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96135|NCT01615939|E2|Reported Event|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
96136|NCT01615939|E1|Reported Event|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
96137|NCT01615822|B4|Baseline|Total|Total of all reporting groups
96138|NCT01615822|B3|Baseline|Placebo|Placebo
96139|NCT01615822|B2|Baseline|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
96140|NCT01615822|B1|Baseline|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
96141|NCT01615822|P3|Participant Flow|Placebo|Placebo
96142|NCT01615822|P2|Participant Flow|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
96143|NCT01615822|P1|Participant Flow|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
96144|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
96145|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
96146|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
96147|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
96148|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
96149|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
96150|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
96151|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
96152|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
96153|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
96154|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
96156|NCT01615822|E3|Reported Event|Placebo|Placebo
96157|NCT01615822|E2|Reported Event|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
96158|NCT01615822|E1|Reported Event|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
96159|NCT01615809|B1|Baseline|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3."
96160|NCT01615809|P1|Participant Flow|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
96161|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
96162|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
96163|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
96164|NCT01615809|E1|Reported Event|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
96165|NCT01615731|B3|Baseline|Total|Total of all reporting groups
96166|NCT01615731|B2|Baseline|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96167|NCT01615731|B1|Baseline|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96168|NCT01615731|P2|Participant Flow|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96169|NCT01615731|P1|Participant Flow|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96170|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96171|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96172|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96173|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96174|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96175|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96176|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96177|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96178|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96179|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96180|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96181|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96182|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96183|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96184|NCT01615731|E2|Reported Event|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96185|NCT01615731|E1|Reported Event|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
96186|NCT01615328|B3|Baseline|Total|Total of all reporting groups
96187|NCT01615328|B2|Baseline|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
96188|NCT01615328|B1|Baseline|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
96189|NCT01615328|P2|Participant Flow|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
96190|NCT01615328|P1|Participant Flow|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
96191|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure."
96192|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure."
96193|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure."
96194|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure."
96195|NCT01615328|O2|Outcome|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
96196|NCT01615328|O1|Outcome|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
96197|NCT01615328|E2|Reported Event|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
96198|NCT01615328|E1|Reported Event|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
96199|NCT01615263|B3|Baseline|Total|Total of all reporting groups
96374|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
98356|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
96200|NCT01615263|B2|Baseline|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96201|NCT01615263|B1|Baseline|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
96202|NCT01615263|P2|Participant Flow|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96203|NCT01615263|P1|Participant Flow|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
96204|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96205|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
96206|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96207|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
96208|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96209|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
96210|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96211|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
96212|NCT01615263|E2|Reported Event|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
96213|NCT01615263|E1|Reported Event|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
96214|NCT01615198|B3|Baseline|Total|Total of all reporting groups
96215|NCT01615198|B2|Baseline|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96216|NCT01615198|B1|Baseline|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96217|NCT01615198|P2|Participant Flow|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96218|NCT01615198|P1|Participant Flow|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96219|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96220|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96221|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96222|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96223|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96375|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96376|NCT01614457|E2|Reported Event|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96224|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96225|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96226|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96227|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96228|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96229|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96230|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96231|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96232|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96233|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96234|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96235|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96236|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96237|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96238|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96239|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96377|NCT01614457|E1|Reported Event|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96240|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96241|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96242|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96243|NCT01615198|E2|Reported Event|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
96244|NCT01615198|E1|Reported Event|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
96245|NCT01614886|B3|Baseline|Total|Total of all reporting groups
96246|NCT01614886|B2|Baseline|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96247|NCT01614886|B1|Baseline|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96248|NCT01614886|P2|Participant Flow|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96249|NCT01614886|P1|Participant Flow|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96250|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96251|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96252|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96253|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96254|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96255|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96256|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96257|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96258|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
96259|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
96260|NCT01614886|E2|Reported Event|Rivastigmine Patch 3-step|Rivastigmine patch 3-step
96261|NCT01614886|E1|Reported Event|Rivastigmine Patch 1-step|Rivastigmine patch 1-step
96262|NCT01614795|B5|Baseline|Total|Total of all reporting groups
96263|NCT01614795|B4|Baseline|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96264|NCT01614795|B3|Baseline|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96378|NCT01614249|B3|Baseline|Total|Total of all reporting groups
96674|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96265|NCT01614795|B2|Baseline|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96266|NCT01614795|B1|Baseline|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96267|NCT01614795|P4|Participant Flow|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96268|NCT01614795|P3|Participant Flow|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96269|NCT01614795|P2|Participant Flow|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96270|NCT01614795|P1|Participant Flow|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96271|NCT01614795|O4|Outcome|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96272|NCT01614795|O3|Outcome|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96273|NCT01614795|O2|Outcome|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96274|NCT01614795|O1|Outcome|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96275|NCT01614795|E4|Reported Event|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96276|NCT01614795|E3|Reported Event|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96277|NCT01614795|E2|Reported Event|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96278|NCT01614795|E1|Reported Event|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
96279|NCT01614769|B1|Baseline|All Participants|All randomized participants
96280|NCT01614769|P6|Participant Flow|Glimepiride 4 mg → Glimepiride 2 mg → Placebo|Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
96281|NCT01614769|P5|Participant Flow|Glimepiride 2 mg → Placebo → Glimepiride 4 mg|Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
96282|NCT01614769|P4|Participant Flow|Placebo → Glimepiride 4 mg → Glimepiride 2 mg|Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
96283|NCT01614769|P3|Participant Flow|Glimepiride 4 mg → Placebo → Glimepiride 2 mg|Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
96284|NCT01614769|P2|Participant Flow|Glimepiride 2 mg → Glimepiride 4 mg → Placebo|Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
96285|NCT01614769|P1|Participant Flow|Placebo → Glimepiride 2 mg → Glimepiride 4 mg|Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
96286|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
96287|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
96288|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
96289|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
96290|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
96291|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
96292|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
96293|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
96294|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
96295|NCT01614769|E3|Reported Event|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
96296|NCT01614769|E2|Reported Event|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
96297|NCT01614769|E1|Reported Event|Placebo|Participants received placebo in a treatment period.
96298|NCT01614613|B1|Baseline|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
96299|NCT01614613|P1|Participant Flow|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
96300|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
96301|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
96302|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
96392|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96303|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
96304|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
96305|NCT01614613|E1|Reported Event|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
96306|NCT01614600|B1|Baseline|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
96307|NCT01614600|P1|Participant Flow|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
96308|NCT01614600|O1|Outcome|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
96309|NCT01614600|E1|Reported Event|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
96310|NCT01614574|B1|Baseline|VPRIV® (15-60 U/kg)|
96311|NCT01614574|P1|Participant Flow|VPRIV® (15-60 U/kg)|
96312|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96313|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96314|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96315|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96316|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96317|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96318|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96319|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96320|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96321|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96322|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
96323|NCT01614574|E1|Reported Event|VPRIV® (15-60 U/kg)|
96324|NCT01614509|B3|Baseline|Total|Total of all reporting groups
96325|NCT01614509|B2|Baseline|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
96326|NCT01614509|B1|Baseline|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
96327|NCT01614509|P2|Participant Flow|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
96328|NCT01614509|P1|Participant Flow|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
96329|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
96330|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
96331|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
96332|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
96393|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96675|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96333|NCT01614509|E2|Reported Event|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
96334|NCT01614509|E1|Reported Event|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
96335|NCT01614470|B3|Baseline|Total|Total of all reporting groups
96336|NCT01614470|B2|Baseline|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
96337|NCT01614470|B1|Baseline|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
96338|NCT01614470|P3|Participant Flow|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
96339|NCT01614470|P2|Participant Flow|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
96340|NCT01614470|P1|Participant Flow|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
96341|NCT01614470|O1|Outcome|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
96342|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96343|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96344|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
96345|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96346|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96347|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
96348|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
96349|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96350|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96351|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
96352|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96353|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96354|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96355|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96356|NCT01614470|E3|Reported Event|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
96357|NCT01614470|E2|Reported Event|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96358|NCT01614470|E1|Reported Event|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
96359|NCT01614457|B3|Baseline|Total|Total of all reporting groups
96360|NCT01614457|B2|Baseline|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96361|NCT01614457|B1|Baseline|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96362|NCT01614457|P2|Participant Flow|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96363|NCT01614457|P1|Participant Flow|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96364|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96365|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96366|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96367|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96368|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96369|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96370|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96371|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96372|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
96373|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
96379|NCT01614249|B2|Baseline|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96380|NCT01614249|B1|Baseline|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96381|NCT01614249|P2|Participant Flow|Fish Oil Omega-3 EPA-rich Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96382|NCT01614249|P1|Participant Flow|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96383|NCT01614249|O2|Outcome|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96384|NCT01614249|O1|Outcome|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96385|NCT01614249|E2|Reported Event|Fish Oil Omega-3 EPA-rich Soft Gels|"Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.~Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits."
96386|NCT01614249|E1|Reported Event|Soybean Oil Soft Gels|"Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.~Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
96387|NCT01613599|B1|Baseline|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96388|NCT01613599|P1|Participant Flow|Rituximab|Participants with granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96389|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96390|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96391|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96394|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96395|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96396|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96397|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96398|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
96399|NCT01613599|E1|Reported Event|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years
96400|NCT01613417|B3|Baseline|Total|Total of all reporting groups
96401|NCT01613417|B2|Baseline|Gadovist/Gadavist Then ProHance|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
96402|NCT01613417|B1|Baseline|ProHance Then Gadovist/Gadavist|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
96403|NCT01613417|P2|Participant Flow|Sequence 2 (Gadovist/Gadavist Then ProHance)|Patients randomized to receive Gadovist/Gadavist first
96404|NCT01613417|P1|Participant Flow|Sequence 1 (ProHance Then Gadovist/Gadavist)|Patients randomized to receive ProHance first
96405|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96406|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
96407|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96408|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
96409|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96410|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
96411|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96412|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
96413|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96414|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
96415|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
96416|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
96417|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
96418|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
96419|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
96420|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
96421|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
96422|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
96423|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
96424|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
96425|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
96426|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
96427|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
96428|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
96429|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
96430|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
96431|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
96432|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
96433|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
96434|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
96435|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
96436|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
96437|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
96438|NCT01613417|E2|Reported Event|Safety Population (Gadovist/Gadavist)|All enrolled patients who received a randomized injection of Gadovist/Gadavist
96439|NCT01613417|E1|Reported Event|Safety Population (ProHance)|All enrolled patients who received a randomized injection of ProHance
96440|NCT01613378|B1|Baseline|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96441|NCT01613378|P1|Participant Flow|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96442|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96443|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96444|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96445|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96676|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96446|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96447|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96448|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96449|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96450|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96451|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96452|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96453|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96454|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96455|NCT01613378|E1|Reported Event|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
96456|NCT01613339|B3|Baseline|Total|Total of all reporting groups
96457|NCT01613339|B2|Baseline|Control|No specific treatment.
96458|NCT01613339|B1|Baseline|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
96459|NCT01613339|P2|Participant Flow|Control|No specific treatment.
96460|NCT01613339|P1|Participant Flow|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
96461|NCT01613339|O2|Outcome|Control|No specific treatment.
96462|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
96463|NCT01613339|O2|Outcome|Control|No specific treatment.
96464|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
96465|NCT01613339|O2|Outcome|Control|No specific treatment.
96466|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
96467|NCT01613339|E1|Reported Event|Body Awareness Therapy, Control|group training. Controls were asked to continue with their lifestyle.
96468|NCT01613326|B3|Baseline|Total|Total of all reporting groups
96469|NCT01613326|B2|Baseline|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96470|NCT01613326|B1|Baseline|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96471|NCT01613326|P2|Participant Flow|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96472|NCT01613326|P1|Participant Flow|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96473|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96474|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96475|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96476|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96477|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96478|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96479|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96480|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96481|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96482|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96483|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96484|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96485|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96486|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96487|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96488|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96489|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96490|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96491|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96492|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96493|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96494|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96495|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96496|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96497|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96498|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96499|NCT01613326|E2|Reported Event|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96500|NCT01613326|E1|Reported Event|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
96501|NCT01613313|B5|Baseline|Total|Total of all reporting groups
96502|NCT01613313|B4|Baseline|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96503|NCT01613313|B3|Baseline|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96504|NCT01613313|B2|Baseline|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96505|NCT01613313|B1|Baseline|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96506|NCT01613313|P4|Participant Flow|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96507|NCT01613313|P3|Participant Flow|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96508|NCT01613313|P2|Participant Flow|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96509|NCT01613313|P1|Participant Flow|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96510|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96511|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96512|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96545|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96513|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96514|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96515|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96516|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96517|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96518|NCT01613313|E4|Reported Event|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96519|NCT01613313|E3|Reported Event|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96520|NCT01613313|E2|Reported Event|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96521|NCT01613313|E1|Reported Event|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
96522|NCT01613248|B7|Baseline|Total|Total of all reporting groups
96523|NCT01613248|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96524|NCT01613248|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96525|NCT01613248|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96526|NCT01613248|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96527|NCT01613248|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96528|NCT01613248|B1|Baseline|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96529|NCT01613248|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96530|NCT01613248|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96531|NCT01613248|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96532|NCT01613248|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96533|NCT01613248|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96534|NCT01613248|P1|Participant Flow|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96535|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96536|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96537|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96538|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96539|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96540|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96541|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96542|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96543|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96544|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96546|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96547|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96548|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96549|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96550|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96551|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96552|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96553|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96554|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96555|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96556|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96557|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96558|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96559|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96560|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96561|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96562|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96563|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96564|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96565|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96566|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96567|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96568|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96569|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96570|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96571|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96572|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96573|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96574|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96575|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96576|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96577|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96578|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96579|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96580|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96581|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96582|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96583|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96584|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96585|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96586|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96587|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96588|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96589|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96590|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96591|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96592|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96593|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96594|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96595|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96596|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96597|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96598|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96599|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96600|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96601|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96602|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96603|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96604|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96605|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96606|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96607|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96608|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96609|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96610|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96611|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96612|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96613|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96614|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96615|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96616|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96617|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96618|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96619|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96620|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96621|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96622|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96623|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96624|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96625|NCT01613248|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96626|NCT01613248|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96627|NCT01613248|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96628|NCT01613248|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96629|NCT01613248|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96630|NCT01613248|E1|Reported Event|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
96631|NCT01613131|B3|Baseline|Total|Total of all reporting groups
96632|NCT01613131|B2|Baseline|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96633|NCT01613131|B1|Baseline|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96634|NCT01613131|P2|Participant Flow|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96635|NCT01613131|P1|Participant Flow|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96636|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96637|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96638|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96639|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96640|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96641|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96642|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
98357|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
96643|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96644|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96645|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96646|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96647|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96648|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96649|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96650|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96651|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96652|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96653|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96654|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96655|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96656|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96657|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96658|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96659|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96660|NCT01613131|E2|Reported Event|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
96661|NCT01613131|E1|Reported Event|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
96662|NCT01613027|B1|Baseline|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96663|NCT01613027|P1|Participant Flow|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96664|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96665|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96666|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96667|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96668|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96669|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96670|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
98358|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
96677|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96678|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96679|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96680|NCT01613027|E1|Reported Event|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
96681|NCT01612858|B3|Baseline|Total|Total of all reporting groups
96682|NCT01612858|B2|Baseline|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
96683|NCT01612858|B1|Baseline|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
96684|NCT01612858|P2|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
96685|NCT01612858|P1|Participant Flow|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
96686|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
96687|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
96688|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
96689|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
96690|NCT01612858|E2|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
96691|NCT01612858|E1|Reported Event|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
96692|NCT01612702|B3|Baseline|Total|Total of all reporting groups
96693|NCT01612702|B2|Baseline|Control|No dexamethasone
96694|NCT01612702|B1|Baseline|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96695|NCT01612702|P2|Participant Flow|Control|No dexamethasone
96696|NCT01612702|P1|Participant Flow|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96697|NCT01612702|O2|Outcome|Control|No dexamethasone
96698|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96699|NCT01612702|O2|Outcome|Control|No dexamethasone
96700|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96701|NCT01612702|O2|Outcome|Control|No dexamethasone
96702|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96703|NCT01612702|E2|Reported Event|Control|No dexamethasone
96704|NCT01612702|E1|Reported Event|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
96705|NCT01612676|B5|Baseline|Total|Total of all reporting groups
96706|NCT01612676|B4|Baseline|Infusion Regimen 4|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96707|NCT01612676|B3|Baseline|Infusion Regimen 3|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96708|NCT01612676|B2|Baseline|Infusion Regimen 2|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96709|NCT01612676|B1|Baseline|Infusion Regimen 1|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96710|NCT01612676|P4|Participant Flow|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96711|NCT01612676|P3|Participant Flow|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96712|NCT01612676|P2|Participant Flow|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96713|NCT01612676|P1|Participant Flow|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96784|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
96714|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96715|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96716|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96717|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96718|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96719|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96720|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96721|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96722|NCT01612676|O1|Outcome|Full Analysis Set|The full analysis data set (FAS) comprised data from all dosed patients.
96723|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96724|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96725|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96726|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96727|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96728|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96729|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96730|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96731|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96732|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96733|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96734|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96735|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96736|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96737|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96738|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96739|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96740|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96741|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96742|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96743|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96744|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96745|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96746|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96747|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96748|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96749|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96750|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96751|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96752|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96753|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96754|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
97030|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
96755|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96756|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96757|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96758|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96759|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96760|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96761|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96762|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96763|NCT01612676|E5|Reported Event|Total|Summation of adverse events in all treatment arms
96764|NCT01612676|E4|Reported Event|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96765|NCT01612676|E3|Reported Event|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96766|NCT01612676|E2|Reported Event|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96767|NCT01612676|E1|Reported Event|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
96768|NCT01612494|B3|Baseline|Total|Total of all reporting groups
96769|NCT01612494|B2|Baseline|Hypertonic Saline|
96770|NCT01612494|B1|Baseline|Normal Saline|
96771|NCT01612494|P2|Participant Flow|Hypertonic Saline|
96772|NCT01612494|P1|Participant Flow|Normal Saline|
96773|NCT01612494|O2|Outcome|Hypertonic Saline|
96774|NCT01612494|O1|Outcome|Normal Saline|
96775|NCT01612494|E2|Reported Event|Hypertonic Saline|
96776|NCT01612494|E1|Reported Event|Normal Saline|
96777|NCT01612156|B3|Baseline|Total|Total of all reporting groups
96778|NCT01612156|B2|Baseline|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
96779|NCT01612156|B1|Baseline|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
96780|NCT01612156|P2|Participant Flow|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
96781|NCT01612156|P1|Participant Flow|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
96782|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
96783|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
96785|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
96786|NCT01612156|E2|Reported Event|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
96787|NCT01612156|E1|Reported Event|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
96788|NCT01612000|B5|Baseline|Total|Total of all reporting groups
96789|NCT01612000|B4|Baseline|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96790|NCT01612000|B3|Baseline|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96791|NCT01612000|B2|Baseline|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96792|NCT01612000|B1|Baseline|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96793|NCT01612000|P4|Participant Flow|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96794|NCT01612000|P3|Participant Flow|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96795|NCT01612000|P2|Participant Flow|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96796|NCT01612000|P1|Participant Flow|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96797|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96798|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96799|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96800|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96801|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96802|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96803|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96804|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96805|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96806|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96807|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96808|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96809|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96810|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96811|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96812|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96813|NCT01612000|E4|Reported Event|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96814|NCT01612000|E3|Reported Event|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
96815|NCT01612000|E2|Reported Event|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96816|NCT01612000|E1|Reported Event|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
96817|NCT01611974|B4|Baseline|Total|Total of all reporting groups
96818|NCT01611974|B3|Baseline|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96819|NCT01611974|B2|Baseline|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96820|NCT01611974|B1|Baseline|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96821|NCT01611974|P3|Participant Flow|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96822|NCT01611974|P2|Participant Flow|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96823|NCT01611974|P1|Participant Flow|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96824|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96825|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96826|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96827|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96828|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96829|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96830|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96831|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96832|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96833|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96834|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96835|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96836|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96837|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96838|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96839|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96840|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96841|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96842|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96843|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96844|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96845|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96846|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96847|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96848|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96849|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96850|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96851|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96852|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96853|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96854|NCT01611974|E3|Reported Event|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96855|NCT01611974|E2|Reported Event|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96856|NCT01611974|E1|Reported Event|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
96857|NCT01611883|B3|Baseline|Total|Total of all reporting groups
96858|NCT01611883|B2|Baseline|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96859|NCT01611883|B1|Baseline|Ezetimibe|10 mg oral dose once daily for 24 weeks
96860|NCT01611883|P2|Participant Flow|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96861|NCT01611883|P1|Participant Flow|Ezetimibe|10 mg oral dose once daily for 24 weeks
96862|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96863|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96864|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96865|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96866|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96867|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96868|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96869|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96870|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96871|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96872|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96873|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96874|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96875|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96876|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96877|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96878|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96879|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96880|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96881|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
96882|NCT01611883|E2|Reported Event|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
96883|NCT01611883|E1|Reported Event|Ezetimibe|10 mg oral dose once daily for 24 weeks
96884|NCT01611857|B3|Baseline|Total|Total of all reporting groups
96885|NCT01611857|B2|Baseline|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
96886|NCT01611857|B1|Baseline|Tivantinib+FOLFOX Dose Escalation|"Tivantinib: (120 mg, 240 mg, or 360 mg) orally, twice daily on Days 1-14 of each 2 week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
96887|NCT01611857|P2|Participant Flow|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle."
96888|NCT01611857|P1|Participant Flow|Tivantinib + FOLFOX Dose Escalation|"Tivantinib: (120 mg; 240 mg; or 360 mg) orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle;~FOLFOX: [5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2] on Day 1 each cycle."
96889|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
96890|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
97233|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
96891|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
96892|NCT01611857|O3|Outcome|Tivantinib 360 mg (PO BID) + FOLFOX|"Tivantinib 360 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
96893|NCT01611857|O2|Outcome|Tivantinib 240 mg (PO BID) + FOLFOX|"Tivantinib 240 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
96894|NCT01611857|O1|Outcome|Tivantinib 120 mg (PO BID) + FOLFOX|"Tivantinib 120 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
96895|NCT01611857|E2|Reported Event|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
96896|NCT01611857|E1|Reported Event|Tivantinib+FOLFOX Dose Escalation|Tivantinib: orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle; FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle.
96897|NCT01611779|B1|Baseline|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96898|NCT01611779|P1|Participant Flow|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96899|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96900|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96901|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96902|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96903|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96904|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96905|NCT01611779|E1|Reported Event|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
96906|NCT01611571|B4|Baseline|Total|Total of all reporting groups
96907|NCT01611571|B3|Baseline|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96908|NCT01611571|B2|Baseline|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96909|NCT01611571|B1|Baseline|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96910|NCT01611571|P3|Participant Flow|Placebo Risedronate + Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96911|NCT01611571|P2|Participant Flow|Active Risedronte + Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96912|NCT01611571|P1|Participant Flow|Active Risedronate + Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96913|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96914|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96915|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96916|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96917|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96918|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96919|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96920|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
97234|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
96921|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96922|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96923|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96924|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96925|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96926|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96927|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96928|NCT01611571|E3|Reported Event|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
96929|NCT01611571|E2|Reported Event|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
96930|NCT01611571|E1|Reported Event|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
96931|NCT01611558|B1|Baseline|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96932|NCT01611558|P1|Participant Flow|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96933|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96934|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96935|NCT01611558|O1|Outcome|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96936|NCT01611558|E1|Reported Event|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
96937|NCT01610791|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96938|NCT01610791|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
96939|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96940|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96941|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96942|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96943|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96944|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96945|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96946|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96947|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96948|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96949|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96950|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96951|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96952|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96953|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96954|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96955|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96956|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96957|NCT01610791|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
96958|NCT01610713|B3|Baseline|Total|Total of all reporting groups
97235|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
96959|NCT01610713|B2|Baseline|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96960|NCT01610713|B1|Baseline|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96961|NCT01610713|P2|Participant Flow|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96962|NCT01610713|P1|Participant Flow|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96963|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96964|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96965|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96966|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96967|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96968|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96969|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96970|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96971|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96972|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96973|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96974|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98359|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
96975|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96976|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96977|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96978|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96979|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96980|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96981|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96982|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96983|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96984|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96985|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96986|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96987|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96988|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96989|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96990|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97236|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
96991|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96992|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96993|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96994|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96995|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96996|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96997|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96998|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
96999|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97000|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97001|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97002|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97003|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97004|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97005|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97006|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97237|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97007|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97008|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97009|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97010|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97011|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97012|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97013|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97014|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97015|NCT01610713|E2|Reported Event|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97016|NCT01610713|E1|Reported Event|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97017|NCT01610700|B3|Baseline|Total|Total of all reporting groups
97018|NCT01610700|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97019|NCT01610700|B1|Baseline|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97020|NCT01610700|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97021|NCT01610700|P1|Participant Flow|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97022|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97023|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97024|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97025|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97026|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97027|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97028|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97029|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97238|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97031|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97032|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97033|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97034|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97035|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97036|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97037|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97038|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97039|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97040|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97041|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97042|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97043|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97044|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97045|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97046|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97047|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97048|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97049|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97050|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97051|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97052|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97053|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97054|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97055|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97056|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97057|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97058|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97059|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97060|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97061|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97062|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97063|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97064|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97065|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97066|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97067|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97068|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97069|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97070|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97071|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97072|NCT01610700|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
97073|NCT01610700|E1|Reported Event|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
97074|NCT01610687|B1|Baseline|GW-1000-02|Active treatment
97075|NCT01610687|P1|Participant Flow|GW-1000-02|GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97076|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97077|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97078|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97079|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97080|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97081|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97082|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97083|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97084|NCT01610687|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
97085|NCT01610596|B3|Baseline|Total|Total of all reporting groups
97086|NCT01610596|B2|Baseline|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97087|NCT01610596|B1|Baseline|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
97088|NCT01610596|P2|Participant Flow|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97089|NCT01610596|P1|Participant Flow|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
97090|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97091|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
97092|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97093|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
97094|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97095|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
97096|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97097|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
97098|NCT01610596|E2|Reported Event|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
97099|NCT01610596|E1|Reported Event|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
97100|NCT01610570|B5|Baseline|Total|Total of all reporting groups
97101|NCT01610570|B4|Baseline|Phase 2|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
97102|NCT01610570|B3|Baseline|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
97103|NCT01610570|B2|Baseline|Phase 1 Dose Level 1|Dose Escalation Phase 13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
97104|NCT01610570|B1|Baseline|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
97105|NCT01610570|P4|Participant Flow|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
97106|NCT01610570|P3|Participant Flow|Phase 1 Dose Level 2|"Dose Escalation Phase~17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
97107|NCT01610570|P2|Participant Flow|Phase 1 Dose Level 1|"Dose Escalation Phase~13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
97108|NCT01610570|P1|Participant Flow|Phase I Dose Level -1|"Dose Escalation Phase~9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
97176|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97177|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97239|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97109|NCT01610570|O4|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97110|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97111|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97112|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97113|NCT01610570|O1|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97114|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97115|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97178|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97179|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97240|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97116|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Ph 9.0 mcg/kg dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97117|NCT01610570|E4|Reported Event|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97118|NCT01610570|E3|Reported Event|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97119|NCT01610570|E2|Reported Event|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97120|NCT01610570|E1|Reported Event|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
97121|NCT01610557|B5|Baseline|Total|Total of all reporting groups
97122|NCT01610557|B4|Baseline|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97123|NCT01610557|B3|Baseline|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97124|NCT01610557|B2|Baseline|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97180|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97181|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97125|NCT01610557|B1|Baseline|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97126|NCT01610557|P5|Participant Flow|Ranibizumab/Bevacizumab As Needed|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~53 participants attended at least one follow-up visit in the post-36-week extension phase: 49 participants who had one eye enrolled and 4 participants who had two eyes enrolled."
97127|NCT01610557|P4|Participant Flow|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97128|NCT01610557|P3|Participant Flow|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97129|NCT01610557|P2|Participant Flow|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97130|NCT01610557|P1|Participant Flow|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97131|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
97132|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
97133|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
97134|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
97135|NCT01610557|E7|Reported Event|Ranibizumab and Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with two eyes assigned who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom one eye was assigned (unilateral participants) are not included."
97136|NCT01610557|E6|Reported Event|Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with one eye assigned in either Group 3 or Group 4 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
97137|NCT01610557|E5|Reported Event|Ranibizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis.~Participants with one eye assigned in either Group 1 or Group 2 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
97138|NCT01610557|E4|Reported Event|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97139|NCT01610557|E3|Reported Event|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97140|NCT01610557|E2|Reported Event|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97141|NCT01610557|E1|Reported Event|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
97142|NCT01610492|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97143|NCT01610492|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97144|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97145|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97146|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97147|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97148|NCT01610492|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
97149|NCT01610453|B1|Baseline|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
97150|NCT01610453|P1|Participant Flow|Results From Transperineal Scan|"Primiparous women with prolonged labours was eligible for the study. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated.~Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge"
97151|NCT01610453|O1|Outcome|Transabdominal Ultrasound|Fetal head position was assessed using a transabdominal scan
97152|NCT01610453|O1|Outcome|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
97153|NCT01610453|E1|Reported Event|Transabdominal and Transperineal Sonography|Fetal head position was assessed using a transabdominal scan and fetal station was assessed by transperineal scan
97154|NCT01610297|B1|Baseline|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97155|NCT01610297|P1|Participant Flow|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97156|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97157|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97158|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97159|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97160|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97161|NCT01610297|E1|Reported Event|ICL670|Oral dose of ICL670 at 10 mg/kg daily
97162|NCT01610167|B4|Baseline|Total|Total of all reporting groups
97163|NCT01610167|B3|Baseline|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97164|NCT01610167|B2|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97165|NCT01610167|B1|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97166|NCT01610167|P3|Participant Flow|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97167|NCT01610167|P2|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97168|NCT01610167|P1|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97169|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97170|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97171|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97172|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97173|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97174|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97175|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97182|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97183|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97184|NCT01610167|E3|Reported Event|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97185|NCT01610167|E2|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97186|NCT01610167|E1|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
97187|NCT01610076|B3|Baseline|Total|Total of all reporting groups
97188|NCT01610076|B2|Baseline|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97189|NCT01610076|B1|Baseline|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
97190|NCT01610076|P2|Participant Flow|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97191|NCT01610076|P1|Participant Flow|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
97192|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97193|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97194|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97195|NCT01610076|O2|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97196|NCT01610076|O1|Outcome|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
97197|NCT01610076|E2|Reported Event|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
97198|NCT01610076|E1|Reported Event|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
97199|NCT01610037|B4|Baseline|Total|Total of all reporting groups
97200|NCT01610037|B3|Baseline|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97201|NCT01610037|B2|Baseline|Tiotropium|18 μg capsules for inhalation, o.d
97202|NCT01610037|B1|Baseline|QVA149|110/50 µg capsules for inhalation, o.d
97203|NCT01610037|P3|Participant Flow|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97204|NCT01610037|P2|Participant Flow|Tiotropium|18 μg capsules for inhalation, o.d
97205|NCT01610037|P1|Participant Flow|QVA149|110/50 µg capsules for inhalation, o.d
97206|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97207|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97208|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97209|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97210|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97211|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97212|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97213|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97214|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97215|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97216|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97217|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97218|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97219|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97220|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97221|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97222|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97223|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97224|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97225|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97226|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97227|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97228|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97229|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97230|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97231|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
97232|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
97242|NCT01610037|E3|Reported Event|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
97243|NCT01610037|E2|Reported Event|Tiotropium|18 μg capsules for inhalation, o.d
97244|NCT01610037|E1|Reported Event|QVA 149|110/50 µg capsules for inhalation, o.d
97245|NCT01610011|B3|Baseline|Total|Total of all reporting groups
97246|NCT01610011|B2|Baseline|Glycine Administration GLDC Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97247|NCT01610011|B1|Baseline|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97248|NCT01610011|P2|Participant Flow|Glycine Administration GLDC Mutation Subjects|Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics. Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
97249|NCT01610011|P1|Participant Flow|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97250|NCT01610011|O2|Outcome|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97251|NCT01610011|O1|Outcome|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97252|NCT01610011|E2|Reported Event|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97253|NCT01610011|E1|Reported Event|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
97254|NCT01609582|B3|Baseline|Total|Total of all reporting groups
97255|NCT01609582|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
97256|NCT01609582|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
97257|NCT01609582|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
97258|NCT01609582|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
97259|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
97260|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
97261|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
97262|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
97263|NCT01609582|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
97264|NCT01609582|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
97265|NCT01609543|B1|Baseline|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
97266|NCT01609543|P1|Participant Flow|Erlotinib Hydrochloride|Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
97267|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
97268|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
97269|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
97270|NCT01609543|E1|Reported Event|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
97271|NCT01609478|B4|Baseline|Total|Total of all reporting groups
97272|NCT01609478|B3|Baseline|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97273|NCT01609478|B2|Baseline|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97274|NCT01609478|B1|Baseline|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97275|NCT01609478|P3|Participant Flow|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97276|NCT01609478|P2|Participant Flow|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97277|NCT01609478|P1|Participant Flow|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97278|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97279|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97280|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97281|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97282|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97283|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97284|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97285|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97286|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97287|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97288|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97289|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97290|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97291|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97292|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97293|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97294|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97295|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97296|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97297|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97298|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97299|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97300|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97301|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97302|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97303|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97304|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97305|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97306|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97307|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97308|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97309|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97310|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97311|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97312|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97313|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97314|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97315|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97316|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97317|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97318|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97319|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97320|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97321|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97322|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97323|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97324|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97325|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97326|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97327|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97328|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97329|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97330|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97331|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97332|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97333|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97334|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97335|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97336|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97337|NCT01609478|E3|Reported Event|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97338|NCT01609478|E2|Reported Event|Indacaterol Acetate 150 mcg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97339|NCT01609478|E1|Reported Event|Indacaterol Acetate 75 mcg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
97340|NCT01609257|B3|Baseline|Total|Total of all reporting groups
97341|NCT01609257|B2|Baseline|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97342|NCT01609257|B1|Baseline|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97343|NCT01609257|P2|Participant Flow|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97344|NCT01609257|P1|Participant Flow|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97345|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97346|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97347|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97348|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97349|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97350|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97351|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97352|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97353|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97354|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97355|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97356|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97357|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97358|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97359|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97360|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97362|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97363|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97364|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97365|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97366|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97367|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97368|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97369|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97370|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97371|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97372|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97373|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97374|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97375|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97376|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97377|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97378|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97379|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97380|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97381|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97382|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97383|NCT01609257|O2|Outcome|Placebo_Not Infected|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97384|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97385|NCT01609257|O2|Outcome|Placebo_Not Ill|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97386|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97387|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97388|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97389|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97390|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97391|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97392|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97393|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97394|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97395|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97396|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97397|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97398|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97399|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97400|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97401|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97402|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97403|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97504|NCT01608815|B1|Baseline|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97404|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97405|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97406|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97407|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97408|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97409|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97410|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97411|NCT01609257|E2|Reported Event|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
97412|NCT01609257|E1|Reported Event|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
97413|NCT01609062|B3|Baseline|Total|Total of all reporting groups
97414|NCT01609062|B2|Baseline|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97415|NCT01609062|B1|Baseline|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97416|NCT01609062|P2|Participant Flow|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97417|NCT01609062|P1|Participant Flow|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97418|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97419|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97420|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97421|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97422|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97423|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97424|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97425|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97426|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97427|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97428|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97429|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97430|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97431|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97432|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97433|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97434|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97435|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97436|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97437|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97438|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97439|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97440|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97441|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97442|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97443|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97444|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97445|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97446|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97447|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97448|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97449|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97450|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97451|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97452|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97453|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97454|NCT01609062|O3|Outcome|All Subjects|Both groups combined
97455|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97456|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97457|NCT01609062|E2|Reported Event|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97458|NCT01609062|E1|Reported Event|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
97459|NCT01609010|B3|Baseline|Total|Total of all reporting groups
97460|NCT01609010|B2|Baseline|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97461|NCT01609010|B1|Baseline|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97462|NCT01609010|P2|Participant Flow|Rituximab + Interferon (IFN)|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-alpha2a (IFN-α2a), 3 million international units per day (MIU/day), subcutaneously (SC), during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97463|NCT01609010|P1|Participant Flow|Rituximab Monotherapy|Participants rituximab received 375 milligrams per square meter (mg/m^2), intravenously (IV), once weekly for 4 weeks. Participants who achieved minor response (MR), partial response (PR), or complete response (CR) after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97464|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97465|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97466|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97467|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97468|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97469|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97470|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97471|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97472|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97473|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97505|NCT01608815|P3|Participant Flow|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97474|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97475|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97476|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97477|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97478|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97479|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97480|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97481|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97482|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97483|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97484|NCT01609010|E2|Reported Event|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97485|NCT01609010|E1|Reported Event|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
97486|NCT01608971|B3|Baseline|Total|Total of all reporting groups
97487|NCT01608971|B2|Baseline|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97488|NCT01608971|B1|Baseline|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97489|NCT01608971|P2|Participant Flow|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97490|NCT01608971|P1|Participant Flow|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97491|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97492|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97493|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97494|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97495|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97496|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97497|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97498|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97499|NCT01608971|E2|Reported Event|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
97500|NCT01608971|E1|Reported Event|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
97501|NCT01608815|B4|Baseline|Total|Total of all reporting groups
97502|NCT01608815|B3|Baseline|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97503|NCT01608815|B2|Baseline|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97506|NCT01608815|P2|Participant Flow|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97507|NCT01608815|P1|Participant Flow|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97508|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97509|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97510|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97511|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97512|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97513|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97514|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97515|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97516|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97517|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97518|NCT01608815|O2|Outcome|Dolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97519|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
97520|NCT01608815|E3|Reported Event|Children (Group 3)|Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
97521|NCT01608815|E2|Reported Event|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
97522|NCT01608815|E1|Reported Event|Adults (Group 1)|Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
97523|NCT01608724|B1|Baseline|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97524|NCT01608724|P1|Participant Flow|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97525|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97526|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97527|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97528|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97529|NCT01608724|E1|Reported Event|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
97530|NCT01608672|B1|Baseline|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97531|NCT01608672|P1|Participant Flow|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97532|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97533|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97534|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97535|NCT01608672|E1|Reported Event|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
97536|NCT01608659|B1|Baseline|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97537|NCT01608659|P1|Participant Flow|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97538|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97539|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97540|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97541|NCT01608659|E1|Reported Event|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
97542|NCT01608308|B3|Baseline|Total|Total of all reporting groups
97543|NCT01608308|B2|Baseline|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97544|NCT01608308|B1|Baseline|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97558|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97545|NCT01608308|P2|Participant Flow|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97546|NCT01608308|P1|Participant Flow|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97547|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97548|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97549|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97550|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97551|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97552|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97553|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97554|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97555|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97556|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97557|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97766|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97767|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97559|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97560|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97561|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97562|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97563|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97564|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97565|NCT01608308|E2|Reported Event|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
97566|NCT01608308|E1|Reported Event|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
97567|NCT01608100|B1|Baseline|ARCHITECT STAT High Sensitive Troponin I Assay Testing|All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.
97568|NCT01608100|P1|Participant Flow|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
97569|NCT01608100|O3|Outcome|Positive Predictive Value in Serum Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97570|NCT01608100|O2|Outcome|Positive Predictive Value in Lithium Heparin Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97571|NCT01608100|O1|Outcome|Positive Predictive Value in K2 EDTA|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97572|NCT01608100|O3|Outcome|Negative Predictive Value in Serum Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
97573|NCT01608100|O2|Outcome|Negative Predictive Value in Lithium Heparin Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
97574|NCT01608100|O1|Outcome|Negative Predictive Value in K2 EDTA|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
97768|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
98360|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97575|NCT01608100|O3|Outcome|Specificity in Serum Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
97576|NCT01608100|O2|Outcome|Specificity in Lithium Heparin Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
97577|NCT01608100|O1|Outcome|Specificity in K2 EDTA|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
97578|NCT01608100|O3|Outcome|Sensitivity in Serum Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97579|NCT01608100|O2|Outcome|Sensitivity in Lithium Heparin Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
97580|NCT01608100|O1|Outcome|Sensitivity in K2 EDTA|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97581|NCT01608100|O6|Outcome|90-day Prognosis for Serum Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97582|NCT01608100|O5|Outcome|30-day Prognosis for Serum Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97583|NCT01608100|O4|Outcome|90-day Prognosis for Lithium Heparin Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97584|NCT01608100|O3|Outcome|30-day Prognosis for Lithium Heparin Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97585|NCT01608100|O2|Outcome|90-day Prognosis for K2 EDTA Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97586|NCT01608100|O1|Outcome|30-day Prognosis for K2 EDTA Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
97587|NCT01608100|O3|Outcome|Area Under the Curve in Serum Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97588|NCT01608100|O2|Outcome|Area Under the Curve in Lithium Heparin Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97589|NCT01608100|O1|Outcome|Area Under the Curve in K2 EDTA|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
97590|NCT01608100|E1|Reported Event|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
97591|NCT01607853|B1|Baseline|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97592|NCT01607853|P1|Participant Flow|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97593|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97594|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97595|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97596|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97597|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97769|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97598|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97599|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97600|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97601|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97602|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97603|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97604|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97605|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97606|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97607|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97608|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97609|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97610|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97611|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97612|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97613|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97614|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97615|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97616|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97617|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97618|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97619|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97620|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97621|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97770|NCT01607450|E7|Reported Event|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
98361|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97622|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97623|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97624|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97625|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97626|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97627|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97628|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97629|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97630|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97631|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97632|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97633|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97634|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97635|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97636|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97637|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97638|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97639|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97640|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97641|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97642|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97643|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97644|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97645|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97771|NCT01607450|E6|Reported Event|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
98362|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97646|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97647|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97648|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97649|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97650|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97651|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97652|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97653|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97654|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97655|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97656|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97657|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97658|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97659|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97660|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97661|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97662|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97663|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97664|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97665|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97666|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97667|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97668|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97669|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97772|NCT01607450|E5|Reported Event|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
98363|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97670|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97671|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97672|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97673|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97674|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97675|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97676|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97677|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97678|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97679|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97680|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97681|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97682|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97683|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97684|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97685|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97686|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97687|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97688|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97689|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97690|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97691|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97692|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97693|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97773|NCT01607450|E4|Reported Event|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
98364|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97694|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97695|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97696|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97697|NCT01607853|E1|Reported Event|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
97698|NCT01607593|B1|Baseline|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians.
97699|NCT01607593|P1|Participant Flow|SERTRALINE|Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
97700|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
97701|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
97702|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
97703|NCT01607593|E1|Reported Event|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians
97704|NCT01607476|B4|Baseline|Total|Total of all reporting groups
97705|NCT01607476|B3|Baseline|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97706|NCT01607476|B2|Baseline|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97707|NCT01607476|B1|Baseline|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97708|NCT01607476|P3|Participant Flow|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97709|NCT01607476|P2|Participant Flow|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97710|NCT01607476|P1|Participant Flow|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97711|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97712|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97713|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97714|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97715|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97716|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97717|NCT01607476|E3|Reported Event|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97954|NCT01606735|E2|Reported Event|517 mcg|IBI-10090: dexamethasone
97718|NCT01607476|E2|Reported Event|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97719|NCT01607476|E1|Reported Event|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
97720|NCT01607450|B8|Baseline|Total|Total of all reporting groups
97721|NCT01607450|B7|Baseline|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97722|NCT01607450|B6|Baseline|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97723|NCT01607450|B5|Baseline|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97724|NCT01607450|B4|Baseline|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97725|NCT01607450|B3|Baseline|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97726|NCT01607450|B2|Baseline|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97727|NCT01607450|B1|Baseline|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97728|NCT01607450|P7|Participant Flow|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97729|NCT01607450|P6|Participant Flow|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97730|NCT01607450|P5|Participant Flow|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97731|NCT01607450|P4|Participant Flow|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97732|NCT01607450|P3|Participant Flow|Type 2 DM GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97733|NCT01607450|P2|Participant Flow|Lean GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97734|NCT01607450|P1|Participant Flow|Lean Placebo|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97735|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97736|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97737|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97738|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97739|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97740|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97741|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97742|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97743|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
97744|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97745|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97746|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97747|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97748|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97749|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97750|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97751|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97752|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97753|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97754|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97755|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97756|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97757|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97758|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97759|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97760|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97761|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97762|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97763|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97764|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
97765|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
97774|NCT01607450|E3|Reported Event|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97775|NCT01607450|E2|Reported Event|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
97776|NCT01607450|E1|Reported Event|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
97777|NCT01607411|B1|Baseline|Overall|All randomized participants who received atleast one dose of the study treatments
97778|NCT01607411|P4|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97779|NCT01607411|P3|Participant Flow|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97780|NCT01607411|P2|Participant Flow|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97781|NCT01607411|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97782|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97783|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97784|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97785|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97786|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97787|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97788|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97789|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97790|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97791|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97792|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97793|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97794|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97795|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97955|NCT01606735|E1|Reported Event|342 mcg|IBI-10090: dexamethasone
97796|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97797|NCT01607411|E4|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97798|NCT01607411|E3|Reported Event|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97799|NCT01607411|E2|Reported Event|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97800|NCT01607411|E1|Reported Event|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
97801|NCT01607398|B3|Baseline|Total|Total of all reporting groups
97802|NCT01607398|B2|Baseline|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97803|NCT01607398|B1|Baseline|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97804|NCT01607398|P2|Participant Flow|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97805|NCT01607398|P1|Participant Flow|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97806|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97807|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97808|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97809|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97810|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97811|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97812|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97813|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97814|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97815|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97816|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97817|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97818|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97819|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97820|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97821|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97822|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97823|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97824|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97825|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97826|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97827|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97828|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97829|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97830|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97831|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97832|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97833|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97834|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97835|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97836|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97837|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97838|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97839|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97840|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97841|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97842|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97843|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97997|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
97844|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97845|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97846|NCT01607398|E2|Reported Event|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97847|NCT01607398|E1|Reported Event|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
97848|NCT01607320|B1|Baseline|All Study Participants|Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
97849|NCT01607320|P2|Participant Flow|Clomiphene|"3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7~Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal"
97850|NCT01607320|P1|Participant Flow|Raloxifene|"3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7~Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal"
97851|NCT01607320|O1|Outcome|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
97852|NCT01607320|E1|Reported Event|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
97853|NCT01607203|B3|Baseline|Total|Total of all reporting groups
97854|NCT01607203|B2|Baseline|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97855|NCT01607203|B1|Baseline|HCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97856|NCT01607203|P2|Participant Flow|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97857|NCT01607203|P1|Participant Flow|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97858|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97859|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97860|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97861|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97862|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97863|NCT01607203|O1|Outcome|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97864|NCT01607203|E2|Reported Event|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
97865|NCT01607203|E1|Reported Event|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
97866|NCT01607112|B3|Baseline|Total|Total of all reporting groups
97867|NCT01607112|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97868|NCT01607112|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97869|NCT01607112|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97870|NCT01607112|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97871|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97872|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97873|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97874|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97875|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97876|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97877|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97878|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97879|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97880|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97881|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97882|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97883|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97884|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97885|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97886|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97887|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97888|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97889|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97890|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97891|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97892|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97893|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97894|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97895|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97896|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97897|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97898|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97899|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97900|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97901|NCT01607112|E2|Reported Event|Elderly Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97998|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
97902|NCT01607112|E1|Reported Event|Adult Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
97903|NCT01606800|B3|Baseline|Total|Total of all reporting groups
97904|NCT01606800|B2|Baseline|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
97905|NCT01606800|B1|Baseline|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
97906|NCT01606800|P2|Participant Flow|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
97907|NCT01606800|P1|Participant Flow|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
97908|NCT01606800|O2|Outcome|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
97909|NCT01606800|O1|Outcome|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
97910|NCT01606800|E2|Reported Event|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
97911|NCT01606800|E1|Reported Event|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
97912|NCT01606748|B3|Baseline|Total|Total of all reporting groups
97913|NCT01606748|B2|Baseline|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97914|NCT01606748|B1|Baseline|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97915|NCT01606748|P2|Participant Flow|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97916|NCT01606748|P1|Participant Flow|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97917|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
97918|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
97919|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
97920|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 PK Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
97921|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
97922|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
97923|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97924|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97925|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
98347|NCT01605877|O1|Outcome|SN6AD2, as Measured With CSV-1000|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
97926|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
97927|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97928|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97929|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97930|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97931|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97932|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97933|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
97934|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
97935|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
97936|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
97937|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
97938|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-In|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
97939|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
97940|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-in|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
97941|NCT01606748|E2|Reported Event|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97942|NCT01606748|E1|Reported Event|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
97943|NCT01606735|B4|Baseline|Total|Total of all reporting groups
97944|NCT01606735|B3|Baseline|697 mcg|IBI-10090: dexamethasone
97945|NCT01606735|B2|Baseline|517 mcg|IBI-10090: dexamethasone
97946|NCT01606735|B1|Baseline|342 mcg|IBI-10090: dexamethasone
97947|NCT01606735|P3|Participant Flow|697 mcg|IBI-10090: dexamethasone
97948|NCT01606735|P2|Participant Flow|517 mcg|IBI-10090: dexamethasone
97949|NCT01606735|P1|Participant Flow|342 mcg|IBI-10090: dexamethasone
97950|NCT01606735|O3|Outcome|697 mcg|IBI-10090: dexamethasone
97951|NCT01606735|O2|Outcome|517 mcg|IBI-10090: dexamethasone
97952|NCT01606735|O1|Outcome|342 mcg|IBI-10090: dexamethasone
97953|NCT01606735|E3|Reported Event|697 mcg|IBI-10090: dexamethasone
97956|NCT01606670|B1|Baseline|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97957|NCT01606670|P1|Participant Flow|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97958|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97959|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97960|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97961|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97962|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97963|NCT01606670|E1|Reported Event|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
97964|NCT01606319|B3|Baseline|Total|Total of all reporting groups
97965|NCT01606319|B2|Baseline|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97966|NCT01606319|B1|Baseline|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97967|NCT01606319|P2|Participant Flow|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97968|NCT01606319|P1|Participant Flow|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97969|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97970|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97971|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97972|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97973|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97974|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97975|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97976|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97977|NCT01606319|E2|Reported Event|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
97978|NCT01606319|E1|Reported Event|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
97979|NCT01606254|B5|Baseline|Total|Total of all reporting groups
97980|NCT01606254|B4|Baseline|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
97981|NCT01606254|B3|Baseline|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
97982|NCT01606254|B2|Baseline|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
97983|NCT01606254|B1|Baseline|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
97984|NCT01606254|P4|Participant Flow|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
97985|NCT01606254|P3|Participant Flow|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
97986|NCT01606254|P2|Participant Flow|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
97987|NCT01606254|P1|Participant Flow|Paliperidone Palmitate 50 mg|Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
97988|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
97989|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
97990|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
97991|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
97992|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
97993|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
97994|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
97995|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
97996|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
97999|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98000|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98001|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98002|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98003|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98004|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98005|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98006|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98007|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98008|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98009|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98010|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98011|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98012|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98013|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98014|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98015|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98016|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98017|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98018|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98019|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98020|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98021|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98022|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98023|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98024|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98025|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98026|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98027|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98028|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98029|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98030|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98031|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98032|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98033|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98034|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98035|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98036|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98037|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98038|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98039|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98040|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98041|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98042|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98043|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98044|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98045|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98046|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98047|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98048|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98049|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98050|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98051|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98052|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98053|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98054|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98055|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98056|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98057|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98058|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98059|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98060|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98061|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98062|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98063|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98064|NCT01606254|E4|Reported Event|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
98065|NCT01606254|E3|Reported Event|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
98066|NCT01606254|E2|Reported Event|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
98067|NCT01606254|E1|Reported Event|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
98068|NCT01606228|B1|Baseline|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98069|NCT01606228|P1|Participant Flow|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98070|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98071|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98072|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98073|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98074|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98075|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98076|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98077|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98078|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98079|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98080|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98081|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98082|NCT01606228|E1|Reported Event|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
98083|NCT01606202|B3|Baseline|Total|Total of all reporting groups
98084|NCT01606202|B2|Baseline|Placebo|Placebo control.
98085|NCT01606202|B1|Baseline|GW-1000-02|Active treatment.
98086|NCT01606202|P2|Participant Flow|Placebo|Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
98087|NCT01606202|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
98088|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98089|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98090|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98091|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98092|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98093|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98094|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98095|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98096|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98097|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98098|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98099|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98100|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98101|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98102|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98103|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98104|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98105|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98106|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98107|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98108|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98109|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98110|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98111|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98112|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98113|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98114|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98115|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98116|NCT01606202|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98117|NCT01606202|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
98118|NCT01606189|B1|Baseline|All Study Treatments: GW-1000-02, GW-2000-02 and Placebo|As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
98119|NCT01606189|P6|Participant Flow|GW-2000-02 First, Then Placebo, Then GW-1000-02|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98120|NCT01606189|P5|Participant Flow|Placebo First, Then GW-2000-02, Then GW-1000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98121|NCT01606189|P4|Participant Flow|GW-1000-02 First, Then Placebo, Then GW-2000-02|"GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98122|NCT01606189|P3|Participant Flow|Placebo First, Then GW-1000-02, Then GW-2000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98123|NCT01606189|P2|Participant Flow|GW-2000-02 First, Then GW-1000-02, Then Placebo|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98124|NCT01606189|P1|Participant Flow|GW-1000-02 First, Then GW-2000-02, Then Placebo|"GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
98125|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98126|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98127|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98128|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98129|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98130|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98131|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98132|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98133|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98134|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98135|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98136|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98137|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98138|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98139|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98140|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98141|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98142|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98143|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98144|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98145|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98146|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98147|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98148|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98149|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98150|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98151|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98152|NCT01606189|E3|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
98153|NCT01606189|E2|Reported Event|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
98154|NCT01606189|E1|Reported Event|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
98155|NCT01606176|B3|Baseline|Total|Total of all reporting groups
98156|NCT01606176|B2|Baseline|Placebo|Placebo control.
98157|NCT01606176|B1|Baseline|GW-1000-02|Active treatment.
98158|NCT01606176|P2|Participant Flow|Placebo|Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
98159|NCT01606176|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
98160|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98161|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98162|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98163|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98164|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98165|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98166|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98167|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98168|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98169|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98170|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98171|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98172|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98173|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98174|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98175|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98176|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98177|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98178|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98179|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98180|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98181|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98182|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98183|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98184|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98185|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98186|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98187|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98188|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98189|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98190|NCT01606176|E2|Reported Event|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
98191|NCT01606176|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
98192|NCT01606150|B3|Baseline|Total|Total of all reporting groups
98193|NCT01606150|B2|Baseline|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
98194|NCT01606150|B1|Baseline|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
98195|NCT01606150|P2|Participant Flow|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
98196|NCT01606150|P1|Participant Flow|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
98197|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
98198|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
98199|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
98200|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
98201|NCT01606150|E2|Reported Event|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
98202|NCT01606150|E1|Reported Event|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
98203|NCT01606137|B1|Baseline|GW-1000-02|Active treatment
98204|NCT01606137|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
98205|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98206|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98207|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98208|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98209|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98210|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98211|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98212|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98213|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98214|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98215|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98216|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98217|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98218|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98275|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98219|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98220|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98221|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98222|NCT01606137|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
98223|NCT01606007|B4|Baseline|Total|Total of all reporting groups
98224|NCT01606007|B3|Baseline|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98225|NCT01606007|B2|Baseline|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98226|NCT01606007|B1|Baseline|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98227|NCT01606007|P3|Participant Flow|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98228|NCT01606007|P2|Participant Flow|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98229|NCT01606007|P1|Participant Flow|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98230|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98231|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98232|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98233|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98234|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98235|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98236|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98237|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98238|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98239|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98240|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98241|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98274|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98242|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98243|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98244|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98245|NCT01606007|E3|Reported Event|SAXA + DAPA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
98246|NCT01606007|E2|Reported Event|DAPA + MET|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
98247|NCT01606007|E1|Reported Event|SAXA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
98248|NCT01605942|B3|Baseline|Total|Total of all reporting groups
98249|NCT01605942|B2|Baseline|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98250|NCT01605942|B1|Baseline|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98251|NCT01605942|P2|Participant Flow|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98252|NCT01605942|P1|Participant Flow|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98253|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98254|NCT01605942|O2|Outcome|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98255|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98256|NCT01605942|E2|Reported Event|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98257|NCT01605942|E1|Reported Event|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
98258|NCT01605916|B6|Baseline|Total|Total of all reporting groups
98259|NCT01605916|B5|Baseline|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98260|NCT01605916|B4|Baseline|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98261|NCT01605916|B3|Baseline|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98262|NCT01605916|B2|Baseline|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98263|NCT01605916|B1|Baseline|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98264|NCT01605916|P5|Participant Flow|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98265|NCT01605916|P4|Participant Flow|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98266|NCT01605916|P3|Participant Flow|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98267|NCT01605916|P2|Participant Flow|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98268|NCT01605916|P1|Participant Flow|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98269|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98270|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98271|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98272|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98273|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98276|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98277|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98278|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98279|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98280|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98281|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98282|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98283|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98284|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98285|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98286|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98287|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98288|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98289|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98290|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98291|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98292|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98293|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98294|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98295|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98296|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98297|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98298|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98299|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98300|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98301|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98302|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98303|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98304|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98305|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98306|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98307|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98308|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98309|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98348|NCT01605877|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98310|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98311|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98312|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98313|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98314|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98315|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98316|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98317|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98318|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98319|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98320|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98321|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98322|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98323|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98324|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98325|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98326|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98327|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98328|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98329|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98330|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98331|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98332|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98333|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98334|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98335|NCT01605916|E5|Reported Event|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
98336|NCT01605916|E4|Reported Event|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
98337|NCT01605916|E3|Reported Event|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
98338|NCT01605916|E2|Reported Event|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98339|NCT01605916|E1|Reported Event|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
98340|NCT01605877|B1|Baseline|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
98341|NCT01605877|P1|Participant Flow|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
98342|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98343|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98344|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98345|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98346|NCT01605877|O2|Outcome|SN6AD2, as Measured With VCTS|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98349|NCT01605877|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98365|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98366|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98367|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98368|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98369|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98370|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98371|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98372|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98373|NCT01605877|O4|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98374|NCT01605877|O3|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98375|NCT01605877|O2|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98376|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98377|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98378|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98379|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98380|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98381|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98382|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98383|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98384|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98385|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98386|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98387|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98388|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98389|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98390|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98391|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98392|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98393|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98394|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98395|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98396|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98397|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98398|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98399|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98400|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
98401|NCT01605877|E1|Reported Event|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
98402|NCT01605825|B3|Baseline|Total|Total of all reporting groups
98403|NCT01605825|B2|Baseline|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
98404|NCT01605825|B1|Baseline|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
98405|NCT01605825|P2|Participant Flow|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
98406|NCT01605825|P1|Participant Flow|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
98407|NCT01605825|O2|Outcome|Dalfampridine-ER|
98408|NCT01605825|O1|Outcome|Placebo|
98409|NCT01605825|E2|Reported Event|Dalfampridine-ER|
98410|NCT01605825|E1|Reported Event|Placebo|
98411|NCT01605799|B3|Baseline|Total|Total of all reporting groups
98412|NCT01605799|B2|Baseline|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
98413|NCT01605799|B1|Baseline|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
98414|NCT01605799|P2|Participant Flow|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
98415|NCT01605799|P1|Participant Flow|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
98416|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
98417|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
98418|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
98419|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
98420|NCT01605799|E2|Reported Event|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
98421|NCT01605799|E1|Reported Event|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
98422|NCT01605669|B1|Baseline|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
98423|NCT01605669|P1|Participant Flow|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
98424|NCT01605669|O2|Outcome|Mean Pressure Gradient <30mmHg (Negative)|
98425|NCT01605669|O1|Outcome|Mean Pressure Gradient >=30mmHg (Positive)|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
98426|NCT01605669|E1|Reported Event|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
98427|NCT01605617|B3|Baseline|Total|Total of all reporting groups
98428|NCT01605617|B2|Baseline|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
98429|NCT01605617|B1|Baseline|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
98430|NCT01605617|P2|Participant Flow|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
98431|NCT01605617|P1|Participant Flow|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
98432|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98433|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98434|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98435|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98436|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98437|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98438|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98640|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98439|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98440|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98441|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98442|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
98443|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
98444|NCT01605617|E4|Reported Event|While on PTNS + Fesoterodine Fumarate Second|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
98445|NCT01605617|E3|Reported Event|While on PTNS + Placebo Second|Participants were to be given PTNS + placebo (12 weeks)
98446|NCT01605617|E2|Reported Event|While on PTNS + Placebo First|Participants were given PTNS + placebo (12 weeks)
98447|NCT01605617|E1|Reported Event|While on PTNS + Fesoterodine Fumarate First|Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
98448|NCT01605552|B3|Baseline|Total|Total of all reporting groups
98449|NCT01605552|B2|Baseline|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98450|NCT01605552|B1|Baseline|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98451|NCT01605552|P2|Participant Flow|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98452|NCT01605552|P1|Participant Flow|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98453|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98454|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98959|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98455|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98456|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98457|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98458|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98459|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98460|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98461|NCT01605552|E2|Reported Event|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
98462|NCT01605552|E1|Reported Event|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
98463|NCT01605539|B3|Baseline|Total|Total of all reporting groups
98677|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98464|NCT01605539|B2|Baseline|CBD Group|"The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98465|NCT01605539|B1|Baseline|Control|"Subjects received pills that resemble the Cannabidiol capsule but did not have its properties.~Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study"
98466|NCT01605539|P3|Participant Flow|CBD 800 Group|Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
98467|NCT01605539|P2|Participant Flow|CBD 400 Group|"Subjects will receive 400 mg of cannabidiol~Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions"
98468|NCT01605539|P1|Participant Flow|Control|"Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study"
98469|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98470|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98471|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98472|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98473|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98474|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98475|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98476|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98477|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98478|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98479|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98480|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98481|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98482|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98483|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98484|NCT01605539|O1|Outcome|Control|"Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98485|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98486|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98487|NCT01605539|E2|Reported Event|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
98488|NCT01605539|E1|Reported Event|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
98489|NCT01605461|B1|Baseline|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98490|NCT01605461|P1|Participant Flow|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98491|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98492|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98493|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98494|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98495|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98496|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98497|NCT01605461|E1|Reported Event|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
98498|NCT01605370|B3|Baseline|Total|Total of all reporting groups
98499|NCT01605370|B2|Baseline|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
98500|NCT01605370|B1|Baseline|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
98501|NCT01605370|P2|Participant Flow|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
98502|NCT01605370|P1|Participant Flow|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
98503|NCT01605370|O2|Outcome|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
98504|NCT01605370|O1|Outcome|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
98505|NCT01605370|E2|Reported Event|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
98506|NCT01605370|E1|Reported Event|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
98507|NCT01605292|B3|Baseline|Total|Total of all reporting groups
98508|NCT01605292|B2|Baseline|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98509|NCT01605292|B1|Baseline|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98510|NCT01605292|P2|Participant Flow|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98511|NCT01605292|P1|Participant Flow|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98512|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98513|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98514|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98515|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98516|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98517|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98518|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98519|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98520|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98521|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98522|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98523|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98524|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98525|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98526|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98527|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98528|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98529|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98530|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98531|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98532|NCT01605292|E2|Reported Event|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
98533|NCT01605292|E1|Reported Event|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
98534|NCT01603875|B4|Baseline|Total|Total of all reporting groups
98535|NCT01603875|B3|Baseline|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98536|NCT01603875|B2|Baseline|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98537|NCT01603875|B1|Baseline|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98538|NCT01603875|P3|Participant Flow|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98539|NCT01603875|P2|Participant Flow|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98540|NCT01603875|P1|Participant Flow|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98541|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98542|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98543|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98544|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98545|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98546|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98547|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98548|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98779|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98549|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98550|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98551|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98552|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98553|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98554|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98555|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98556|NCT01603875|E3|Reported Event|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98557|NCT01603875|E2|Reported Event|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98558|NCT01603875|E1|Reported Event|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
98559|NCT01604941|B3|Baseline|Total|Total of all reporting groups
98560|NCT01604941|B2|Baseline|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98561|NCT01604941|B1|Baseline|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98562|NCT01604941|P6|Participant Flow|SPD602 75mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 75 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
98563|NCT01604941|P5|Participant Flow|SPD602 50mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 50 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
98564|NCT01604941|P4|Participant Flow|SPD602 75mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
98565|NCT01604941|P3|Participant Flow|SPD602 50mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
98566|NCT01604941|P2|Participant Flow|SPD602 75mg/kg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
98567|NCT01604941|P1|Participant Flow|SPD602 50mg/mg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
98568|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98569|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98570|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98571|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98572|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98573|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98574|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98575|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98576|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98577|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98639|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98578|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98579|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98580|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98581|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98582|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98583|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98584|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98585|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98586|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98587|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98588|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
98589|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
98590|NCT01604941|E2|Reported Event|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
98591|NCT01604941|E1|Reported Event|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
98592|NCT01604850|B3|Baseline|Total|Total of all reporting groups
98593|NCT01604850|B2|Baseline|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98594|NCT01604850|B1|Baseline|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98595|NCT01604850|P2|Participant Flow|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98596|NCT01604850|P1|Participant Flow|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98597|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98598|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98599|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98600|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98601|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98602|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98603|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98604|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98605|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98606|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98607|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98608|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98609|NCT01604850|E2|Reported Event|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
98610|NCT01604850|E1|Reported Event|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
98611|NCT01604772|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
98612|NCT01604772|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
98613|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
98614|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
98615|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|
98616|NCT01604772|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
98617|NCT01604278|B3|Baseline|Total|Total of all reporting groups
98618|NCT01604278|B2|Baseline|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98619|NCT01604278|B1|Baseline|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98620|NCT01604278|P2|Participant Flow|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98621|NCT01604278|P1|Participant Flow|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98622|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98623|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98624|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98625|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98626|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98627|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98628|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98629|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98630|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98631|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98632|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98633|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98634|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98635|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98636|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98637|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98638|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98641|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98642|NCT01604278|E2|Reported Event|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
98643|NCT01604278|E1|Reported Event|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
98644|NCT01604265|B3|Baseline|Total|Total of all reporting groups
98645|NCT01604265|B2|Baseline|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98646|NCT01604265|B1|Baseline|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98647|NCT01604265|P2|Participant Flow|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98648|NCT01604265|P1|Participant Flow|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98649|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98650|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98651|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98652|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98653|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98654|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98655|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98656|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98657|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98658|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98659|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98660|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98661|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98662|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98663|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98664|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98665|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98666|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98667|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98668|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98669|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98670|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98671|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98672|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98673|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98674|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98675|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98676|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98875|NCT01603277|B1|Baseline|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
98678|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98679|NCT01604265|E2|Reported Event|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
98680|NCT01604265|E1|Reported Event|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
98681|NCT01604109|B3|Baseline|Total|Total of all reporting groups
98682|NCT01604109|B2|Baseline|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
98683|NCT01604109|B1|Baseline|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
98684|NCT01604109|P2|Participant Flow|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
98685|NCT01604109|P1|Participant Flow|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
98686|NCT01604109|O2|Outcome|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
98687|NCT01604109|O1|Outcome|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
98688|NCT01604109|E2|Reported Event|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
98689|NCT01604109|E1|Reported Event|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
98690|NCT01603940|B3|Baseline|Total|Total of all reporting groups
98691|NCT01603940|B2|Baseline|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98692|NCT01603940|B1|Baseline|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98693|NCT01603940|P2|Participant Flow|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98694|NCT01603940|P1|Participant Flow|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98695|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98696|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98697|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98698|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98699|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98700|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98701|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98702|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98703|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98704|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98705|NCT01603940|E2|Reported Event|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
98706|NCT01603940|E1|Reported Event|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
98707|NCT01603459|B1|Baseline|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
98742|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98708|NCT01603459|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
98709|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98710|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98711|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98712|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98713|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98714|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98715|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98716|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98717|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98718|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98719|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98720|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98721|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98722|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98723|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98724|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98725|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98726|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98727|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98728|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98729|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98730|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98731|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98732|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98733|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98734|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98735|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98736|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98737|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98738|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98739|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98740|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98741|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98743|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98744|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98745|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98746|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98747|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98748|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98749|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98750|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98751|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98752|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98753|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98754|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98755|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98756|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98757|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98758|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98759|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98760|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98761|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98762|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98763|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98764|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98765|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98766|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98767|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98768|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98769|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98770|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98771|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98772|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98773|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98774|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98775|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98776|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98777|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98778|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98780|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98781|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98782|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98783|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98784|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98785|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98786|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98787|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98788|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98789|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98790|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98791|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98792|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98793|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98794|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98795|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98796|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98797|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98798|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98799|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98800|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98801|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98802|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98803|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98804|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98805|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98806|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98807|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98808|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98809|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98810|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98811|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98812|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98813|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Timeframe 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98876|NCT01603277|P2|Participant Flow|Normal Saline|Placebo: Normal Saline
98814|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98815|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98816|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98817|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98818|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98819|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98820|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98821|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
98822|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98823|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
98824|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98825|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
98826|NCT01603459|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
98827|NCT01603420|B3|Baseline|Total|Total of all reporting groups
98828|NCT01603420|B2|Baseline|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98829|NCT01603420|B1|Baseline|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98830|NCT01603420|P2|Participant Flow|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98831|NCT01603420|P1|Participant Flow|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98832|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98833|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98834|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98835|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98836|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98837|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98877|NCT01603277|P1|Participant Flow|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
98878|NCT01603277|O2|Outcome|Normal Saline|Placebo: Normal Saline
98838|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98839|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98840|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98841|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98842|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98843|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98844|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98845|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98846|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98847|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98848|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98849|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98850|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98851|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98852|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98853|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98872|NCT01603394|E1|Reported Event|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98854|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98855|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98856|NCT01603420|E2|Reported Event|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98857|NCT01603420|E1|Reported Event|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
98858|NCT01603394|B1|Baseline|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98859|NCT01603394|P1|Participant Flow|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98860|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98861|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98862|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98863|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98864|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98865|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98866|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98867|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98868|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98869|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98870|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98871|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
98873|NCT01603277|B3|Baseline|Total|Total of all reporting groups
98874|NCT01603277|B2|Baseline|Normal Saline|Placebo: Normal Saline
98958|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98879|NCT01603277|O1|Outcome|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
98880|NCT01603277|E2|Reported Event|Normal Saline|Placebo: Normal Saline
98881|NCT01603277|E1|Reported Event|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
98882|NCT01603121|B1|Baseline|All Study Participants|Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
98883|NCT01603121|P2|Participant Flow|Lisofylline Intravenous First, Then Lisofylline Subcutaneous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98884|NCT01603121|P1|Participant Flow|Lisofylline Subcutaneous First, Then Lisofylline Intravenous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98885|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98886|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98887|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98888|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98889|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98890|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98891|NCT01603121|E2|Reported Event|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98892|NCT01603121|E1|Reported Event|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
98893|NCT01603082|B3|Baseline|Total|Total of all reporting groups
98894|NCT01603082|B2|Baseline|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98895|NCT01603082|B1|Baseline|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98896|NCT01603082|P2|Participant Flow|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98897|NCT01603082|P1|Participant Flow|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98898|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98899|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98900|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98901|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98902|NCT01603082|E2|Reported Event|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98903|NCT01603082|E1|Reported Event|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
98904|NCT01603056|B3|Baseline|Total|Total of all reporting groups
98905|NCT01603056|B2|Baseline|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98906|NCT01603056|B1|Baseline|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98907|NCT01603056|P2|Participant Flow|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98908|NCT01603056|P1|Participant Flow|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98909|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98910|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98911|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98912|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98913|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98914|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98915|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98916|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98917|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98918|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98919|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98920|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98921|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98922|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98923|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98924|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98925|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98926|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98927|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98928|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98929|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98930|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98931|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98932|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98933|NCT01603056|E2|Reported Event|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98934|NCT01603056|E1|Reported Event|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
98935|NCT01603043|B3|Baseline|Total|Total of all reporting groups
98936|NCT01603043|B2|Baseline|Sham Injection|1 mock injection per month for 12 months
98937|NCT01603043|B1|Baseline|AL-78898A|1 intravitreal injection per month for up to 12 months
98938|NCT01603043|P2|Participant Flow|Sham Injection|1 mock injection per month for 12 months
98939|NCT01603043|P1|Participant Flow|AL-78898A|1 intravitreal injection per month for up to 12 months
98940|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
98941|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
98942|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
98943|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
98944|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
98945|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
98946|NCT01603043|E2|Reported Event|Sham Injection|1 mock injection per month for 12 months
98947|NCT01603043|E1|Reported Event|AL-78898A|1 intravitreal injection per month for up to 12 months
98948|NCT01602744|B3|Baseline|Total|Total of all reporting groups
98949|NCT01602744|B2|Baseline|Intervention STOPP/START|Screening medications with STOPP/START critera
98950|NCT01602744|B1|Baseline|Controll|The medications in this arm will not be screened.
98951|NCT01602744|P2|Participant Flow|Intervention STOPP/START|Screening medications with STOPP/START critera
98952|NCT01602744|P1|Participant Flow|Controll|The medications in this arm will not be screened.
98953|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98954|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98955|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98956|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98957|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98960|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98961|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98962|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98963|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
98964|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
98965|NCT01602744|E2|Reported Event|Intervention STOPP/START|Screening medications with STOPP/START critera
98966|NCT01602744|E1|Reported Event|Controll|The medications in this arm will not be screened.
98967|NCT01602731|B1|Baseline|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
98968|NCT01602731|P1|Participant Flow|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
98969|NCT01602731|O1|Outcome|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
98970|NCT01602731|O2|Outcome|After AMDD|Adherence was measured with the use of the AMDD as a 30-day pill count
98971|NCT01602731|O1|Outcome|Before AMDD|Adherence was measured by 30-day pill count before the use of AMDD
98972|NCT01602731|E1|Reported Event|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
98973|NCT01602562|B3|Baseline|Total|Total of all reporting groups
98974|NCT01602562|B2|Baseline|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98975|NCT01602562|B1|Baseline|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98976|NCT01602562|P2|Participant Flow|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98977|NCT01602562|P1|Participant Flow|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98978|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98979|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98980|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98981|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98982|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98983|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99024|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
98984|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98985|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98986|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98987|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98988|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98989|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98990|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98991|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98992|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98993|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98994|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98995|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98996|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98997|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
98998|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and & <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99120|NCT01602471|O1|Outcome|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
98999|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99000|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99001|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99002|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99003|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99004|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99005|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99006|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99007|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99008|NCT01602562|E2|Reported Event|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99009|NCT01602562|E1|Reported Event|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
99010|NCT01602549|B3|Baseline|Total|Total of all reporting groups
99011|NCT01602549|B2|Baseline|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99012|NCT01602549|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99013|NCT01602549|P2|Participant Flow|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99014|NCT01602549|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99015|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99016|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99017|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99018|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99019|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99020|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99021|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99022|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99023|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99025|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99026|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99027|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99028|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99029|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99030|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99031|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99032|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99033|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99034|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99035|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99036|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99037|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99038|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99039|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99040|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99041|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99042|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99043|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99044|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99045|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99046|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99047|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99048|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99049|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99050|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99051|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99052|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99053|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99054|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99055|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99056|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99057|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99058|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99059|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99060|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99061|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99062|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
99063|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99064|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99065|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99066|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99067|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99068|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99121|NCT01602471|E1|Reported Event|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
99069|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99070|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99071|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99072|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99073|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99074|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99075|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99076|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99077|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99078|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99079|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99080|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99081|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99082|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99083|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99084|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99085|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99086|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99087|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99088|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99089|NCT01602549|E3|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 milligrams (mg) administered orally once daily for 7 to 9 days.
99090|NCT01602549|E2|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
99091|NCT01602549|E1|Reported Event|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
99092|NCT01602510|B1|Baseline|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200 mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
99093|NCT01602510|P3|Participant Flow|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99094|NCT01602510|P2|Participant Flow|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99095|NCT01602510|P1|Participant Flow|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
99096|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99097|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99098|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99099|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99100|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99122|NCT01602016|B1|Baseline|All Participants|
99123|NCT01602016|P1|Participant Flow|All Participants|
99124|NCT01602016|O1|Outcome|All Participants|
99125|NCT01602016|E1|Reported Event|All Participants|
99101|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99102|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99103|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99104|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99105|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99106|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99107|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99108|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99109|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99110|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99111|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99112|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99113|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99114|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99115|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99116|NCT01602510|E2|Reported Event|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
99117|NCT01602510|E1|Reported Event|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
99118|NCT01602471|B1|Baseline|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
99119|NCT01602471|P1|Participant Flow|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
99126|NCT01601977|B1|Baseline|All Participants|Single arm crossover nonrandomised study
99127|NCT01601977|P1|Participant Flow|All Study Participants|Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
99128|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99129|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99130|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99131|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99132|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99133|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99134|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99135|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99136|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99137|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99138|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99139|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99140|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
99141|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99142|NCT01601977|E2|Reported Event|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care"
99143|NCT01601977|E1|Reported Event|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
99144|NCT01601821|B3|Baseline|Total|Total of all reporting groups
99145|NCT01601821|B2|Baseline|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99146|NCT01601821|B1|Baseline|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99147|NCT01601821|P2|Participant Flow|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99148|NCT01601821|P1|Participant Flow|CsA+Rapamune+CS|Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99149|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99150|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99151|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99152|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99153|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99154|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99155|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99156|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99157|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99158|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99159|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99160|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99161|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99162|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99163|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99164|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99165|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99166|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99167|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99168|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99169|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99170|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99171|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99172|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99173|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99174|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99175|NCT01601821|E2|Reported Event|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99176|NCT01601821|E1|Reported Event|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
99177|NCT01601782|B1|Baseline|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
99178|NCT01601782|P1|Participant Flow|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
99179|NCT01601782|O1|Outcome|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
99258|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99180|NCT01601782|E1|Reported Event|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
99181|NCT01601691|B1|Baseline|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
99182|NCT01601691|P1|Participant Flow|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
99183|NCT01601691|O1|Outcome|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
99184|NCT01601691|E1|Reported Event|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
99185|NCT01601470|B1|Baseline|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99186|NCT01601470|P1|Participant Flow|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99187|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99188|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99189|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99190|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99191|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99192|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99193|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99194|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99195|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99196|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
99197|NCT01601470|E3|Reported Event|Period 3: LCZ696 + Sildenafil|In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
99198|NCT01601470|E2|Reported Event|Period 2: LCZ696|In Period 2 (study Days 3-7), participants received LCZ696 once daily.
99199|NCT01601470|E1|Reported Event|Period 1: Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2.
99200|NCT01601132|B1|Baseline|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99201|NCT01601132|P1|Participant Flow|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99202|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99203|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99204|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99205|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99206|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99207|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99208|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99209|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99210|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99211|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99212|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
99213|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
99214|NCT01601132|E3|Reported Event|Colchicine + Theophylline|Theophylline 300 mg, solution, orally, single dose and colchicine 0.6 mg, tablets, orally, twice daily, on Day 19.
99215|NCT01601132|E2|Reported Event|Colchicine|Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
99216|NCT01601132|E1|Reported Event|Theophylline|Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
99217|NCT01600950|B1|Baseline|All Participants|A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
99218|NCT01600950|P2|Participant Flow|Lantus/LY2963016|"A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2."
99219|NCT01600950|P1|Participant Flow|LY2963016/Lantus|"A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2."
99220|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99221|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99222|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99223|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99224|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99225|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99226|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99227|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99228|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99229|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99230|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99231|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99232|NCT01600950|E2|Reported Event|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
99233|NCT01600950|E1|Reported Event|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
99234|NCT01600885|B1|Baseline|Overall Study|
99235|NCT01600885|P2|Participant Flow|Placebo Then Guanfacine|"During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.~Placebo then Guanfacine: During the first study session, the patient will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo."
99259|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99383|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99236|NCT01600885|P1|Participant Flow|Guanfacine Then Placebo|"During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.~Guanfacine then Placebo: During the first study session, the patient will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given a placebo instead of the guanfacine."
99237|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99238|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99239|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99240|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99241|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99242|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99243|NCT01600885|E2|Reported Event|Placebo|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99244|NCT01600885|E1|Reported Event|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
99245|NCT01600729|B1|Baseline|All Participants|Participants with facial lines. There was no intervention in this study.
99246|NCT01600729|P1|Participant Flow|All Participants|Participants with facial lines. There was no intervention in this study.
99247|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
99248|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
99249|NCT01600729|E1|Reported Event|All Participants|Participants with facial lines. There was no intervention in this study.
99250|NCT01600716|B3|Baseline|Total|Total of all reporting groups
99251|NCT01600716|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99252|NCT01600716|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99253|NCT01600716|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99254|NCT01600716|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99255|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99256|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99257|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99260|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99261|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99262|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99263|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
99264|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
99265|NCT01600716|E4|Reported Event|Placebo (Normal Saline)/OnabotulinumtoxinA|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.
99266|NCT01600716|E3|Reported Event|OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.
99267|NCT01600716|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.
99268|NCT01600716|E1|Reported Event|OnabotulinumtoxinA Treatment Cycle 1|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.
99269|NCT01600703|B1|Baseline|All Study Participants|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
99270|NCT01600703|P2|Participant Flow|Sitagliptin First, Then Placebo|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
99271|NCT01600703|P1|Participant Flow|Placebo First, Then Sitagliptin|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
99272|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
99273|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
99274|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
99275|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
99276|NCT01600703|E2|Reported Event|Sitagliptin|sitagliptin, 100mg, oral, single dose
99277|NCT01600703|E1|Reported Event|Placebo|placebo, oral, single dose
99278|NCT01600677|B3|Baseline|Total|Total of all reporting groups
99279|NCT01600677|B2|Baseline|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99280|NCT01600677|B1|Baseline|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99281|NCT01600677|P2|Participant Flow|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99282|NCT01600677|P1|Participant Flow|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99283|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99284|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99285|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99286|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99287|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99288|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99289|NCT01600677|E2|Reported Event|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
99290|NCT01600677|E1|Reported Event|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
99291|NCT01600495|B3|Baseline|Total|Total of all reporting groups
99292|NCT01600495|B2|Baseline|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99293|NCT01600495|B1|Baseline|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
99294|NCT01600495|P2|Participant Flow|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99295|NCT01600495|P1|Participant Flow|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
99296|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99297|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
99298|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99299|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
99300|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99301|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
99302|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99303|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
99304|NCT01600495|E2|Reported Event|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
99305|NCT01600495|E1|Reported Event|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
99306|NCT01600287|B3|Baseline|Total|Total of all reporting groups
99307|NCT01600287|B2|Baseline|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99308|NCT01600287|B1|Baseline|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99309|NCT01600287|P2|Participant Flow|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99310|NCT01600287|P1|Participant Flow|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99311|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99312|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99313|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99314|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99315|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99316|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99317|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99318|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99319|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99320|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99321|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99322|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99323|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99324|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99325|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99326|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99327|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99328|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99329|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99330|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99331|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99332|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99333|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99334|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99335|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99336|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99337|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99338|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99384|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99339|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99340|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99341|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99342|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99343|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99344|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99345|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99346|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99347|NCT01600287|E2|Reported Event|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
99348|NCT01600287|E1|Reported Event|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
99349|NCT01600222|B1|Baseline|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99350|NCT01600222|P1|Participant Flow|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
99351|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
99352|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99353|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99354|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99355|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99356|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99357|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99358|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99359|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99360|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99361|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99362|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99363|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99364|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99365|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99366|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99367|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99368|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99369|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99370|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99371|NCT01600222|E1|Reported Event|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
99372|NCT01599104|B4|Baseline|Total|Total of all reporting groups
99373|NCT01599104|B3|Baseline|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99374|NCT01599104|B2|Baseline|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99375|NCT01599104|B1|Baseline|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99376|NCT01599104|P3|Participant Flow|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99377|NCT01599104|P2|Participant Flow|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99378|NCT01599104|P1|Participant Flow|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99379|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99380|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99381|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99382|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99385|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99386|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99387|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99388|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99389|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99390|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99391|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99392|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99393|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99394|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99395|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99396|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99397|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99398|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99399|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99400|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99401|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99402|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99403|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99404|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99405|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99406|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99407|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99408|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99409|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99410|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99411|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99412|NCT01599104|E3|Reported Event|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
99413|NCT01599104|E2|Reported Event|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
99414|NCT01599104|E1|Reported Event|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
99415|NCT01598987|B1|Baseline|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
99416|NCT01598987|P1|Participant Flow|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
99417|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
99418|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
99419|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
99420|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
99421|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
99422|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
99423|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
99424|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
99425|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
99426|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
99427|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
99428|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
99429|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
99430|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
99431|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
99432|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
99433|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
99434|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
99435|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
99436|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
99437|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
99438|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
99439|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
99440|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
99441|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
99442|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
99443|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
99444|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
99445|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
99446|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
99447|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
99448|NCT01598987|E1|Reported Event|All Patients|All patients
99449|NCT01600092|B3|Baseline|Total|Total of all reporting groups
99450|NCT01600092|B2|Baseline|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99451|NCT01600092|B1|Baseline|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99452|NCT01600092|P2|Participant Flow|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99453|NCT01600092|P1|Participant Flow|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99454|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99455|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99456|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99457|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99458|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99459|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99460|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99461|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99462|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99463|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99464|NCT01600092|E2|Reported Event|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99560|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99561|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99465|NCT01600092|E1|Reported Event|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
99466|NCT01600053|B1|Baseline|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
99467|NCT01600053|P1|Participant Flow|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
99468|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
99469|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
99470|NCT01600053|E1|Reported Event|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
99471|NCT01600014|B1|Baseline|Ingenol Mebutate 0.015% Gel (1.& 2. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or controlled repeat use (2nd cycle) treatment of recalcitrant or recurrent AK lesions
99472|NCT01600014|P2|Participant Flow|Vehicle Gel (2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with vehicle gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
99473|NCT01600014|P1|Participant Flow|Ingenol Mebutate Gel, 0.015% (1st & 2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
99474|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
99475|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
99476|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
99477|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
99478|NCT01600014|O5|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
99479|NCT01600014|O4|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
99480|NCT01600014|O3|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
99481|NCT01600014|O2|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
99482|NCT01600014|O1|Outcome|Open Label Only (1st Cycle)|Subjects only treated during 1st cycle (450 participants excluding 203 participants also included in the 2nd cycle)
99483|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
99484|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
99485|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
99486|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
99562|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99487|NCT01600014|E3|Reported Event|Vehicle Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with vehicle gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
99488|NCT01600014|E2|Reported Event|Ingenol Mebutate 0.015% Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
99489|NCT01600014|E1|Reported Event|Ingenol Mebutate 0.015% Gel (1. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel within a 25 cm2 treatment area on the face or scalp
99490|NCT01599806|B3|Baseline|Total|Total of all reporting groups
99491|NCT01599806|B2|Baseline|Doripenem|Doripenem treatment group
99492|NCT01599806|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
99493|NCT01599806|P2|Participant Flow|Doripenem|Doripenem treatment group
99494|NCT01599806|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
99495|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99496|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99497|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99498|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99499|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99500|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99501|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99502|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99503|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99504|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99505|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99506|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99507|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99508|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99509|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99510|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99511|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99512|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99513|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99514|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99515|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99516|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99517|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99518|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99519|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99520|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99521|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99522|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99523|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99524|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99525|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99526|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99527|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99528|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99529|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99530|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99531|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99532|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99533|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99534|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99535|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99536|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99537|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99538|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99539|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99540|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99541|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99542|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99543|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99544|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99545|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99546|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99547|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99548|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99549|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99550|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99551|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99552|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99553|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99554|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99555|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99556|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99557|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99558|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99559|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99564|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99565|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99566|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99567|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99568|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99569|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99570|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99571|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99572|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99573|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99574|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99575|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99576|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99577|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99578|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99579|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99580|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99581|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99582|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99583|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99584|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99585|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99586|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99587|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99588|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99589|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99590|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99591|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99592|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99593|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99594|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99595|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99596|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99597|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99598|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99599|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99600|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99601|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99602|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99603|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99604|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99605|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99606|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99607|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99608|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99609|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99610|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99611|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99612|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99613|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
99614|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99615|NCT01599806|E2|Reported Event|Doripenem|Doripenem treatment group
99616|NCT01599806|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
99617|NCT01599741|B1|Baseline|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
99618|NCT01599741|P1|Participant Flow|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
99619|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
99620|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
99621|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
99622|NCT01599741|E1|Reported Event|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
99623|NCT01599650|B4|Baseline|Total|Total of all reporting groups
99624|NCT01599650|B3|Baseline|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99625|NCT01599650|B2|Baseline|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99626|NCT01599650|B1|Baseline|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99627|NCT01599650|P3|Participant Flow|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99628|NCT01599650|P2|Participant Flow|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99629|NCT01599650|P1|Participant Flow|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99630|NCT01599650|O1|Outcome|3- Laser Monotherapy|laser therapy + Ranibizumab 0.5 mg after Month 6
99631|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99632|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99633|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99634|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99635|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99636|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99637|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99638|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99639|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99640|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99641|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99642|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99643|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99644|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99645|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99646|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99647|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99648|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99649|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99650|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99651|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99652|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99653|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99654|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99655|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99656|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99657|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
99658|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
99659|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
99660|NCT01599650|E4|Reported Event|Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6|Laser monotherapy without Ranibizumab 0.5 mg from Month 6
99661|NCT01599650|E3|Reported Event|Laser Monotherapy With Ranibizumab 0.5 mg From Month 6|Laser monotherapy with Ranibizumab 0.5 mg from Month 6
99662|NCT01599650|E2|Reported Event|Ranibizumab 0.5mg + Laser|"Ranibizumab 0.5mg + Laser~[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm."
99663|NCT01599650|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
99664|NCT01599637|B4|Baseline|Total|Total of all reporting groups
99665|NCT01599637|B3|Baseline|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
99666|NCT01599637|B2|Baseline|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
99667|NCT01599637|B1|Baseline|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99668|NCT01599637|P3|Participant Flow|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
99669|NCT01599637|P2|Participant Flow|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
99670|NCT01599637|P1|Participant Flow|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99671|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99672|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99673|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99674|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99675|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99676|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99677|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99678|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99679|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99680|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99681|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99682|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99683|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99684|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99685|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99686|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99687|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99688|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99689|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99690|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99691|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99692|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99693|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99694|NCT01599637|O2|Outcome|Urticaria Patients|All patients for study at baseline
99695|NCT01599637|O1|Outcome|Healthy Subjects|Baseline Value, healthy volunteers, no treatment applied
99696|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99697|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99698|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99699|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99700|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99701|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99702|NCT01599637|O2|Outcome|Placebo IGE025|Dosed every 4 weeks up to 12 weeks
99703|NCT01599637|O1|Outcome|IGE025|Dosed every 4 weeks up to 12 weeks
99704|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99705|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99706|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99707|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99708|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99709|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99710|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
99711|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
99712|NCT01599637|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks at the study center.
99713|NCT01599637|E1|Reported Event|IGE025 300mg|IGE025 administered subcutaneously every 4 weeks at the study center
99714|NCT01599325|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99715|NCT01599325|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99716|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99717|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99718|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99719|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99720|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99721|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99722|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99723|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99724|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99725|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99726|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99727|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99728|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99729|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99730|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99731|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99732|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99733|NCT01599325|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
99734|NCT01599234|B3|Baseline|Total|Total of all reporting groups
99735|NCT01599234|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99736|NCT01599234|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99737|NCT01599234|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99738|NCT01599234|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99739|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99740|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99741|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99742|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99743|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99744|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99745|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99746|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99747|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99748|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99749|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99750|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99751|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99752|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99753|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99754|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99755|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99756|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99757|NCT01599234|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
99758|NCT01599234|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
99783|NCT01598545|B1|Baseline|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99784|NCT01598545|P1|Participant Flow|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99922|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99759|NCT01598779|B1|Baseline|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
99760|NCT01598779|P1|Participant Flow|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
99761|NCT01598779|O1|Outcome|Women With External Genital Warts|"Women age 15–45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical flat warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.~Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known"
99762|NCT01598779|E1|Reported Event|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
99763|NCT01598740|B3|Baseline|Total|Total of all reporting groups
99764|NCT01598740|B2|Baseline|CLP/CLP + Spiro|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
99765|NCT01598740|B1|Baseline|CLP + Spiro/CLP|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
99766|NCT01598740|P2|Participant Flow|CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
99767|NCT01598740|P1|Participant Flow|CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
99768|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
99769|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|CLP: oral administration
99770|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
99771|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|oral administration
99772|NCT01598740|E2|Reported Event|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
99773|NCT01598740|E1|Reported Event|Treatment Group: CLP Alone|oral administration
99774|NCT01598610|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99775|NCT01598610|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99776|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99777|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99778|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99779|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99780|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99781|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99782|NCT01598610|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
99842|NCT01597908|P2|Participant Flow|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99785|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99786|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99787|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99788|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99789|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99790|NCT01598545|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
99791|NCT01598532|B1|Baseline|Transcranial LED Treatment|"All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.~The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.~The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test."
99792|NCT01598532|P1|Participant Flow|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
99793|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
99794|NCT01598532|O1|Outcome|Transcranial LED Treatment|"All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.~MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each."
99795|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
99796|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
99797|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
99798|NCT01598532|O1|Outcome|Transcranial LED Treatment|MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
99799|NCT01598532|E1|Reported Event|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
99800|NCT01598506|B1|Baseline|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99801|NCT01598506|P1|Participant Flow|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99802|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99803|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99804|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99805|NCT01598506|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
99806|NCT01598428|B1|Baseline|Cataract|
99897|NCT01597479|O1|Outcome|dPNBs Group|we practiced ultrasound guided dPNBs on radial and median nerves using a long acting and low concentration local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
100250|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99807|NCT01598428|P1|Participant Flow|Cataract|During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
99808|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
99809|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
99810|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
99811|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
99812|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
99813|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
99814|NCT01598428|E1|Reported Event|Cataract|
99815|NCT01598350|B1|Baseline|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
99816|NCT01598350|P1|Participant Flow|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
99817|NCT01598350|O1|Outcome|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
99818|NCT01598350|E1|Reported Event|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
99819|NCT01598129|B1|Baseline|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99820|NCT01598129|P1|Participant Flow|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99821|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99822|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99823|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99824|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99825|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99826|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99827|NCT01598129|E1|Reported Event|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
99828|NCT01598064|B3|Baseline|Total|Total of all reporting groups
99829|NCT01598064|B2|Baseline|Placebo|Placebo 1 pack tid for 8 weeks
99830|NCT01598064|B1|Baseline|GK#10|GK#10 1 pk tid for 8 weeks
99831|NCT01598064|P2|Participant Flow|Placebo|Placebo 1 pack tid for 8 weeks
99832|NCT01598064|P1|Participant Flow|GK#10|GK#10 1 pk tid for 8 weeks
99833|NCT01598064|O2|Outcome|Placebo: 8 Week|Placebo 1 pack three times per day for 8 weeks, and F/U ALT level.
99834|NCT01598064|O1|Outcome|GK#10: 8 Week|GK#10 1 pack three times per day for 8 weeks, and F/U ALT level.
99835|NCT01598064|O2|Outcome|Placebo|Placebo 1 pack tid for 8 weeks
99836|NCT01598064|O1|Outcome|GK#10|GK#10 1 pk tid for 8 weeks
99837|NCT01598064|E2|Reported Event|Placebo|Placebo 1 pack tid for 8 weeks
99838|NCT01598064|E1|Reported Event|GK#10|GK#10 1 pk tid for 8 weeks
99839|NCT01597908|B3|Baseline|Total|Total of all reporting groups
99840|NCT01597908|B2|Baseline|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99841|NCT01597908|B1|Baseline|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
100251|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
99843|NCT01597908|P1|Participant Flow|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 milligrams (mg) orally twice daily (BID) and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99844|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99845|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99846|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99847|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99848|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99849|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99850|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99851|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99852|NCT01597908|E2|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99853|NCT01597908|E1|Reported Event|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
99854|NCT01597843|B4|Baseline|Total|Total of all reporting groups
99855|NCT01597843|B3|Baseline|Education After Data Collection Complete|This group received a similar intervention, but after all quantitative data collection complete.
99856|NCT01597843|B2|Baseline|Second Intervention Group|"The group that receives the intervention second. The intervention is the same as for the first group.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
99857|NCT01597843|B1|Baseline|First Educational Intervention Group|"Group that receives intervention first. The intervention is a series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
99858|NCT01597843|P3|Participant Flow|Control First Round; Control Second Round; Intervention|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
99859|NCT01597843|P2|Participant Flow|Control First Round; Education in Second Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
99860|NCT01597843|P1|Participant Flow|Education in First Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
99861|NCT01597843|O3|Outcome|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
99862|NCT01597843|O2|Outcome|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
99898|NCT01597479|O2|Outcome|Non Distal Peripheral Nerve Blocks (Non dPNBs Group)|Patients in non dPNBs didn't received any intervention in the postoperatively period.
99863|NCT01597843|O1|Outcome|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
99864|NCT01597843|E3|Reported Event|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
99865|NCT01597843|E2|Reported Event|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
99866|NCT01597843|E1|Reported Event|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
99867|NCT01597596|B3|Baseline|Total|Total of all reporting groups
99868|NCT01597596|B2|Baseline|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99869|NCT01597596|B1|Baseline|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99870|NCT01597596|P2|Participant Flow|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99871|NCT01597596|P1|Participant Flow|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg intravenous (IV) infusion every other week (QOW) for 52 weeks.
99872|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99873|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99874|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99875|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99876|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99877|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99878|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99879|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99880|NCT01597596|E2|Reported Event|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99881|NCT01597596|E1|Reported Event|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
99882|NCT01597492|B3|Baseline|Total|Total of all reporting groups
99883|NCT01597492|B2|Baseline|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
99884|NCT01597492|B1|Baseline|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
99885|NCT01597492|P2|Participant Flow|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
99886|NCT01597492|P1|Participant Flow|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
99887|NCT01597492|O2|Outcome|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
99888|NCT01597492|O1|Outcome|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
99889|NCT01597492|E2|Reported Event|Belimumab Plus Late Vaccination|Belimumab plus Late Vaccination
99890|NCT01597492|E1|Reported Event|Belimumab Plus Early Vaccination|Belimumab plus Early Vaccination
99891|NCT01597479|B3|Baseline|Total|Total of all reporting groups
99892|NCT01597479|B2|Baseline|Non dPNBs Group|Non intervention in postoperative period
99893|NCT01597479|B1|Baseline|dPNBs Group|dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
99894|NCT01597479|P2|Participant Flow|No Intervention (no dPNBs Group)|In patients of no dPNBs group didn't performed any intervention after surgery.
99895|NCT01597479|P1|Participant Flow|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator.~Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).~We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance."
99896|NCT01597479|O2|Outcome|Non dPNBs Group|In this group any intervention was done.
100067|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
99899|NCT01597479|O1|Outcome|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge.~Distal median nerve block was performed at the elbow, in the internal bicipital channel.~Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm.~We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks."
99900|NCT01597479|E1|Reported Event|Distal Peripheral Nerve Block Group|Any patient undergoing ultrasound guided distal peripheral nerve block reported any complication.
99901|NCT01597245|B5|Baseline|Total|Total of all reporting groups
99902|NCT01597245|B4|Baseline|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99903|NCT01597245|B3|Baseline|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99904|NCT01597245|B2|Baseline|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99905|NCT01597245|B1|Baseline|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99906|NCT01597245|P13|Participant Flow|Ixe Q2W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99907|NCT01597245|P12|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99908|NCT01597245|P11|Participant Flow|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99909|NCT01597245|P10|Participant Flow|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99910|NCT01597245|P9|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99911|NCT01597245|P8|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99912|NCT01597245|P7|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99913|NCT01597245|P6|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
99914|NCT01597245|P5|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99915|NCT01597245|P4|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12
99916|NCT01597245|P3|Participant Flow|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99917|NCT01597245|P2|Participant Flow|50 mg Etanercept (ETN) - Induction Period|50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99918|NCT01597245|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99919|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99920|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99921|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99923|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99924|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99925|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99926|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99927|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99928|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99929|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99930|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99931|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99932|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99933|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99934|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99935|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99936|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99937|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99938|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99939|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99940|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99941|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99942|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99943|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99944|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99945|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99946|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
100252|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
99947|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99948|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99949|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99950|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99951|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99952|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99953|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99954|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99955|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99956|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99957|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99958|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99959|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99960|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99961|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99962|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99963|NCT01597245|O3|Outcome|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99964|NCT01597245|O2|Outcome|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56 .
99965|NCT01597245|O1|Outcome|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99966|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99967|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99968|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99969|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
100068|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
99970|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99971|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99972|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99973|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99974|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99975|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99976|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99977|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99978|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99979|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99980|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99981|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99982|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99983|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99984|NCT01597245|O2|Outcome|50 mg Etanercept (ETN) - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99985|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
99986|NCT01597245|E14|Reported Event|Ixe Q4W Maintenance Period Relapsed Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99987|NCT01597245|E13|Reported Event|Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99988|NCT01597245|E12|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99989|NCT01597245|E11|Reported Event|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99990|NCT01597245|E10|Reported Event|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99991|NCT01597245|E9|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99992|NCT01597245|E8|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
100066|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
99993|NCT01597245|E7|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
99994|NCT01597245|E6|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
99995|NCT01597245|E5|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
99996|NCT01597245|E4|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99997|NCT01597245|E3|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
99998|NCT01597245|E2|Reported Event|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
99999|NCT01597245|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
100000|NCT01597141|B3|Baseline|Total|Total of all reporting groups
100001|NCT01597141|B2|Baseline|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
100002|NCT01597141|B1|Baseline|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
100003|NCT01597141|P2|Participant Flow|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
100004|NCT01597141|P1|Participant Flow|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
100005|NCT01597141|O2|Outcome|Enhanced Standard Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
100006|NCT01597141|O1|Outcome|Family-aided Assertive Community Treatment|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
100007|NCT01597141|O2|Outcome|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
100008|NCT01597141|O1|Outcome|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
100009|NCT01597141|E2|Reported Event|Enhanced Standard Treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
100010|NCT01597141|E1|Reported Event|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
100011|NCT01597050|B3|Baseline|Total|Total of all reporting groups
100012|NCT01597050|B2|Baseline|Placebo|"Placebo, bid~Placebo: Placebo, bid"
100013|NCT01597050|B1|Baseline|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
100014|NCT01597050|P2|Participant Flow|Placebo|"Placebo, bid~Placebo: Placebo, bid"
100015|NCT01597050|P1|Participant Flow|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
100016|NCT01597050|O2|Outcome|Placebo|"Placebo, bid~Placebo: Placebo, bid"
100017|NCT01597050|O1|Outcome|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
100018|NCT01597050|E2|Reported Event|Placebo|"Placebo, bid~Placebo: Placebo, bid"
100019|NCT01597050|E1|Reported Event|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
100020|NCT01596972|B3|Baseline|Total|Total of all reporting groups
100021|NCT01596972|B2|Baseline|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100022|NCT01596972|B1|Baseline|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100023|NCT01596972|P2|Participant Flow|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100024|NCT01596972|P1|Participant Flow|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100025|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100026|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100027|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100028|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100029|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100030|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100031|NCT01596972|E2|Reported Event|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
100032|NCT01596972|E1|Reported Event|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
100033|NCT01596842|B3|Baseline|Total|Total of all reporting groups
100034|NCT01596842|B2|Baseline|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100035|NCT01596842|B1|Baseline|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100036|NCT01596842|P2|Participant Flow|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100037|NCT01596842|P1|Participant Flow|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100038|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100039|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100040|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100041|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100042|NCT01596842|E2|Reported Event|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100043|NCT01596842|E1|Reported Event|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
100044|NCT01596504|B4|Baseline|Total|Total of all reporting groups
100045|NCT01596504|B3|Baseline|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100046|NCT01596504|B2|Baseline|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100047|NCT01596504|B1|Baseline|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100048|NCT01596504|P3|Participant Flow|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100049|NCT01596504|P2|Participant Flow|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100050|NCT01596504|P1|Participant Flow|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100051|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100052|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100053|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100054|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100055|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100056|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100057|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100058|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100059|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100060|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100061|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100062|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100063|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100064|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100065|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100253|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100069|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100070|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100071|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100072|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100073|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100074|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100075|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100076|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100077|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100078|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100079|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100080|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100081|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100082|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100083|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100084|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100085|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100086|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100087|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100088|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100089|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100090|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100091|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100092|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100093|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100094|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100095|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100096|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100097|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100098|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100099|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100100|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100101|NCT01596504|O1|Outcome|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100175|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
100102|NCT01596504|E3|Reported Event|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
100103|NCT01596504|E2|Reported Event|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
100104|NCT01596504|E1|Reported Event|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
100105|NCT01596231|B3|Baseline|Total|Total of all reporting groups
100106|NCT01596231|B2|Baseline|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
100107|NCT01596231|B1|Baseline|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
100108|NCT01596231|P2|Participant Flow|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
100109|NCT01596231|P1|Participant Flow|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
100110|NCT01596231|O2|Outcome|Kudzu|Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
100111|NCT01596231|O1|Outcome|Placebo|Placebo did not alter alcohol consumption compared to baseline.
100112|NCT01596231|E2|Reported Event|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
100113|NCT01596231|E1|Reported Event|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
100114|NCT01596088|B1|Baseline|Dexrazoxane|
100115|NCT01596088|P1|Participant Flow|Dexrazoxane|
100116|NCT01596088|O1|Outcome|Dexrazoxane|
100117|NCT01596088|E1|Reported Event|Dexrazoxane|
100118|NCT01596062|B4|Baseline|Total|Total of all reporting groups
100119|NCT01596062|B3|Baseline|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100120|NCT01596062|B2|Baseline|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100121|NCT01596062|B1|Baseline|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100122|NCT01596062|P3|Participant Flow|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100123|NCT01596062|P2|Participant Flow|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100124|NCT01596062|P1|Participant Flow|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100125|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100126|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100127|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100128|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100129|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100130|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100131|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100132|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100133|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100134|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100135|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100136|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100137|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100138|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100139|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100140|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100141|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100142|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100143|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100144|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100145|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100146|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100147|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100148|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100149|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100150|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100151|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100152|NCT01596062|E3|Reported Event|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
100153|NCT01596062|E2|Reported Event|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
100154|NCT01596062|E1|Reported Event|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
100155|NCT01595854|B6|Baseline|Total|Total of all reporting groups
100156|NCT01595854|B5|Baseline|Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3|"A randomised two-period cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
100157|NCT01595854|B4|Baseline|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
100158|NCT01595854|B3|Baseline|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
100159|NCT01595854|B2|Baseline|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
100160|NCT01595854|B1|Baseline|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
100161|NCT01595854|P5|Participant Flow|Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3|"A randomised, two-period, cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
100162|NCT01595854|P4|Participant Flow|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
100163|NCT01595854|P3|Participant Flow|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
100164|NCT01595854|P2|Participant Flow|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
100165|NCT01595854|P1|Participant Flow|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
100166|NCT01595854|O6|Outcome|Dabigatran + Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
100167|NCT01595854|O5|Outcome|Dabigatran 75 mg - Part 3|A single dose of Dabigatran etexilate 75 mg
100168|NCT01595854|O4|Outcome|Ticagrelor 180 mg - Part 2|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
100169|NCT01595854|O3|Outcome|Dabigatran 220 mg - Part 2|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
100170|NCT01595854|O2|Outcome|Ticagrelor 180 mg - Part 1|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
100171|NCT01595854|O1|Outcome|Dabigatran 220 mg - Part 1|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
100172|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
100173|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
100174|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
100176|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
100177|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
100178|NCT01595854|E6|Reported Event|Multiple Dose Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
100179|NCT01595854|E5|Reported Event|Dabi 75 mg - Part 3|A single dose of dabigatran etexilate (Dabi) 75 mg
100180|NCT01595854|E4|Reported Event|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
100181|NCT01595854|E3|Reported Event|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
100182|NCT01595854|E2|Reported Event|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
100183|NCT01595854|E1|Reported Event|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
100184|NCT01595438|B3|Baseline|Total|Total of all reporting groups
100185|NCT01595438|B2|Baseline|Doripenem|Doripenem treatment group
100186|NCT01595438|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
100187|NCT01595438|P2|Participant Flow|Doripenem|Doripenem treatment group
100188|NCT01595438|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
100189|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100190|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100191|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100192|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100193|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100194|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100195|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100196|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100197|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100198|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100199|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100200|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100201|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100202|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100203|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100204|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100205|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100206|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100207|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100208|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100209|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100210|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100211|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100212|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100213|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100214|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100215|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100216|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100217|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100218|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100219|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100220|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100221|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100222|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100223|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100224|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100225|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100226|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100227|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100228|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100229|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100230|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100231|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100232|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100233|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100234|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100235|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100236|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100237|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100238|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100239|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100240|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100241|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100242|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100243|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100244|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100245|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100246|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100247|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100248|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100254|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100255|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100256|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100257|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100258|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100259|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100260|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100261|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100262|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100263|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100264|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100265|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100266|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100267|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100268|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100269|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100270|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100271|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100272|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100273|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100274|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100275|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100276|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100277|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100278|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100279|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100280|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100281|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100282|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100283|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100284|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100285|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100286|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100287|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100288|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100289|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100290|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100291|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100292|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100293|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100294|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100295|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100296|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100297|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100298|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100299|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100300|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100301|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100302|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100303|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100304|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100305|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100306|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100307|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
100308|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
100309|NCT01595438|E2|Reported Event|Doripenem|Doripenem treatment group
100310|NCT01595438|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
100311|NCT01595386|B3|Baseline|Total|Total of all reporting groups
100312|NCT01595386|B2|Baseline|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100313|NCT01595386|B1|Baseline|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100314|NCT01595386|P2|Participant Flow|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100360|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100361|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100315|NCT01595386|P1|Participant Flow|Normal Saline|"The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100316|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100317|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100318|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100319|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100320|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100321|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100322|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100323|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100324|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100325|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100326|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100327|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100362|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100363|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100328|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100329|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100330|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100331|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100332|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100333|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100334|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100335|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100336|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100337|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100338|NCT01595386|E2|Reported Event|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
100339|NCT01595386|E1|Reported Event|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
100340|NCT01595282|B3|Baseline|Total|Total of all reporting groups
100341|NCT01595282|B2|Baseline|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100364|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100365|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100342|NCT01595282|B1|Baseline|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100343|NCT01595282|P2|Participant Flow|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100344|NCT01595282|P1|Participant Flow|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100345|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100346|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100347|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100348|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100349|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100350|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100351|NCT01595282|E2|Reported Event|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
100352|NCT01595282|E1|Reported Event|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
100353|NCT01594970|B4|Baseline|Total|Total of all reporting groups
100354|NCT01594970|B3|Baseline|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100355|NCT01594970|B2|Baseline|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100356|NCT01594970|B1|Baseline|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100357|NCT01594970|P3|Participant Flow|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100358|NCT01594970|P2|Participant Flow|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100359|NCT01594970|P1|Participant Flow|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100961|NCT01591616|O27|Outcome|Vital Signs (Diastolic), 240 Minutes Post-dose|
100366|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100367|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100368|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100369|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100370|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100371|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100372|NCT01594970|E3|Reported Event|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
100373|NCT01594970|E2|Reported Event|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
100374|NCT01594970|E1|Reported Event|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
100375|NCT01594749|B3|Baseline|Total|Total of all reporting groups
100376|NCT01594749|B2|Baseline|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100377|NCT01594749|B1|Baseline|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100378|NCT01594749|P2|Participant Flow|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100379|NCT01594749|P1|Participant Flow|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100380|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100381|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100413|NCT01594515|P2|Participant Flow|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100382|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100383|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100384|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100385|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100386|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100387|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100388|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100389|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100414|NCT01594515|P1|Participant Flow|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100415|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100728|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100390|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100391|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100392|NCT01594749|E2|Reported Event|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100393|NCT01594749|E1|Reported Event|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
100394|NCT01594515|B11|Baseline|Total|Total of all reporting groups
100395|NCT01594515|B10|Baseline|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100396|NCT01594515|B9|Baseline|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100397|NCT01594515|B8|Baseline|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100398|NCT01594515|B7|Baseline|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100399|NCT01594515|B6|Baseline|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100400|NCT01594515|B5|Baseline|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100401|NCT01594515|B4|Baseline|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100402|NCT01594515|B3|Baseline|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100403|NCT01594515|B2|Baseline|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100404|NCT01594515|B1|Baseline|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100405|NCT01594515|P10|Participant Flow|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100406|NCT01594515|P9|Participant Flow|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100407|NCT01594515|P8|Participant Flow|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100408|NCT01594515|P7|Participant Flow|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100409|NCT01594515|P6|Participant Flow|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100410|NCT01594515|P5|Participant Flow|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100411|NCT01594515|P4|Participant Flow|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100412|NCT01594515|P3|Participant Flow|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100514|NCT01594294|B3|Baseline|Total|Total of all reporting groups
100416|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100417|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100418|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100419|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100420|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100421|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100422|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100423|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100424|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100425|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100426|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100427|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100428|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100429|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100430|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100431|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100432|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100433|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100434|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100435|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100436|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100437|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100438|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100439|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100440|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100441|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100442|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100443|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100444|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100445|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100446|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100447|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100448|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100449|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100450|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100726|NCT01592760|P2|Participant Flow|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100451|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100452|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100453|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100454|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100455|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100456|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100457|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100458|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100459|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100460|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100461|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100462|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100463|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100464|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100465|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100466|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100467|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100468|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100469|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100470|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100471|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100472|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100473|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100474|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100475|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100476|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100477|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100478|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100479|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100480|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100481|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100482|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100483|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100484|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100485|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100727|NCT01592760|P1|Participant Flow|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100486|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100487|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100488|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100489|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100490|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100491|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100492|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100493|NCT01594515|E10|Reported Event|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100494|NCT01594515|E9|Reported Event|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100495|NCT01594515|E8|Reported Event|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100496|NCT01594515|E7|Reported Event|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100497|NCT01594515|E6|Reported Event|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100498|NCT01594515|E5|Reported Event|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100499|NCT01594515|E4|Reported Event|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100500|NCT01594515|E3|Reported Event|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100501|NCT01594515|E2|Reported Event|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
100502|NCT01594515|E1|Reported Event|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
100503|NCT01594424|B1|Baseline|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
100504|NCT01594424|P1|Participant Flow|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
100505|NCT01594424|O1|Outcome|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
100506|NCT01594424|E1|Reported Event|IVIG + Tocilizumab|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
100507|NCT01594411|B1|Baseline|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
100508|NCT01594411|P1|Participant Flow|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
100509|NCT01594411|O4|Outcome|Invasive Angiography|Physician decision for invasive coronary angiography after receiving patients' GES
100510|NCT01594411|O3|Outcome|Stress Test|Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES
100511|NCT01594411|O2|Outcome|Medical Therapy|Physician decision for lifestyle changes or medical therapy after receiving patients' GES
100512|NCT01594411|O1|Outcome|No Tests/Treatment|Physician decision for no additional tests or cardiac treatment after receiving patients' GES
100513|NCT01594411|E1|Reported Event|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
100515|NCT01594294|B2|Baseline|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100516|NCT01594294|B1|Baseline|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100517|NCT01594294|P2|Participant Flow|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100518|NCT01594294|P1|Participant Flow|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100519|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100520|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100521|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100522|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100523|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100524|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100525|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100526|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100527|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100528|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100529|NCT01594294|E2|Reported Event|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100530|NCT01594294|E1|Reported Event|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
100531|NCT01594125|B6|Baseline|Total|Total of all reporting groups
100532|NCT01594125|B5|Baseline|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100533|NCT01594125|B4|Baseline|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100534|NCT01594125|B3|Baseline|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100535|NCT01594125|B2|Baseline|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100536|NCT01594125|B1|Baseline|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100537|NCT01594125|P5|Participant Flow|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100538|NCT01594125|P4|Participant Flow|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100539|NCT01594125|P3|Participant Flow|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100540|NCT01594125|P2|Participant Flow|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100541|NCT01594125|P1|Participant Flow|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100542|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100543|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100544|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100962|NCT01591616|O26|Outcome|Vital Signs (Diastolic), 230 Minutes Post-dose|
100545|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100546|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100547|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100548|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100549|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100550|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100551|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100552|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100553|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100554|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100555|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100556|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100557|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100558|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100559|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100560|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100561|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100562|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100563|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100564|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100565|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100566|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100567|NCT01594125|E5|Reported Event|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
100568|NCT01594125|E4|Reported Event|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
100724|NCT01592760|B1|Baseline|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
100569|NCT01594125|E3|Reported Event|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
100570|NCT01594125|E2|Reported Event|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
100571|NCT01594125|E1|Reported Event|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
100572|NCT01593852|B3|Baseline|Total|Total of all reporting groups
100573|NCT01593852|B2|Baseline|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100574|NCT01593852|B1|Baseline|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100575|NCT01593852|P2|Participant Flow|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100576|NCT01593852|P1|Participant Flow|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100577|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100578|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100579|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100580|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100581|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100582|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100583|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100584|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100585|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100586|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100587|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100588|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100589|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100590|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100591|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100592|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100593|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100594|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100595|NCT01593852|E2|Reported Event|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
100596|NCT01593852|E1|Reported Event|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
100597|NCT01593787|B4|Baseline|Total|Total of all reporting groups
100598|NCT01593787|B3|Baseline|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100599|NCT01593787|B2|Baseline|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100600|NCT01593787|B1|Baseline|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100601|NCT01593787|P3|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100602|NCT01593787|P2|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100603|NCT01593787|P1|Participant Flow|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100604|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100605|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100606|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100607|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100608|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100609|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100610|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100611|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100612|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100613|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100614|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100615|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100616|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100617|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100618|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100619|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100620|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100621|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100622|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100623|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100624|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100625|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100626|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100627|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100628|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100629|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100630|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100631|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100632|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
100633|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
100634|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
100635|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
100636|NCT01593787|E4|Reported Event|LCZ 200 mg|LCZ 200 mg
100637|NCT01593787|E3|Reported Event|Total LCZ696|All participants who received LCZ696
100638|NCT01593787|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
100639|NCT01593787|E1|Reported Event|LCZ 100 mg|LCZ 100 mg
100640|NCT01593722|B3|Baseline|Total|Total of all reporting groups
100641|NCT01593722|B2|Baseline|SIngle Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100642|NCT01593722|B1|Baseline|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100643|NCT01593722|P2|Participant Flow|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100644|NCT01593722|P1|Participant Flow|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100645|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100646|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100647|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100648|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100649|NCT01593722|O2|Outcome|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100650|NCT01593722|O1|Outcome|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100651|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100652|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100653|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100654|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100655|NCT01593722|E2|Reported Event|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
100656|NCT01593722|E1|Reported Event|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
100657|NCT01593592|B3|Baseline|Total|Total of all reporting groups
100658|NCT01593592|B2|Baseline|Control Group|The control group that will receive the standard triple therapy and placebo
100659|NCT01593592|B1|Baseline|Lactobacillus Reuteri Group|The active group that will receive the standard triple therapy and Lactobacillus reuteri
100660|NCT01593592|P2|Participant Flow|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
100661|NCT01593592|P1|Participant Flow|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
100662|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
100663|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
100664|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
100665|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
100725|NCT01592760|P3|Participant Flow|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100666|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
100667|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
100668|NCT01593592|E2|Reported Event|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
100669|NCT01593592|E1|Reported Event|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
100670|NCT01593215|B3|Baseline|Total|Total of all reporting groups
100671|NCT01593215|B2|Baseline|Yohimbine First Then Yohimbine|Yohimbine first and then placebo
100672|NCT01593215|B1|Baseline|Placebo First Then Yohimbine|"placebo first~Yohimbine: Yohimbine capsule"
100673|NCT01593215|P2|Participant Flow|Yohimbine First Then Placebo|Yohimbine first, 2 weeks washout and then placebo
100674|NCT01593215|P1|Participant Flow|Placebo First Then Yohimbine|Placebo first, then 2 weeks washout and then yohimbine
100675|NCT01593215|O2|Outcome|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
100676|NCT01593215|O1|Outcome|Placebo|"placebo~Yohimbine: Yohimbine capsule"
100677|NCT01593215|E2|Reported Event|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
100678|NCT01593215|E1|Reported Event|Placebo|"placebo~Yohimbine: Yohimbine capsule"
100679|NCT01592864|B3|Baseline|Total|Total of all reporting groups
100680|NCT01592864|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100681|NCT01592864|B1|Baseline|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100682|NCT01592864|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100683|NCT01592864|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.
100684|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100685|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100686|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100687|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100688|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100689|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100690|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100691|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100692|NCT01592864|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100693|NCT01592864|E1|Reported Event|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
100694|NCT01592851|B3|Baseline|Total|Total of all reporting groups
100695|NCT01592851|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100696|NCT01592851|B1|Baseline|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100697|NCT01592851|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water.
100698|NCT01592851|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100699|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100700|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100701|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100702|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100703|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100704|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100705|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100706|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100707|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100708|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100709|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100710|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100711|NCT01592851|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
100712|NCT01592851|E1|Reported Event|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
100713|NCT01592786|B1|Baseline|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
100714|NCT01592786|P1|Participant Flow|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
100715|NCT01592786|O1|Outcome|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
100716|NCT01592786|E1|Reported Event|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
100717|NCT01592773|B1|Baseline|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
100718|NCT01592773|P1|Participant Flow|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
100719|NCT01592773|O1|Outcome|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
100720|NCT01592773|E1|Reported Event|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
100721|NCT01592760|B4|Baseline|Total|Total of all reporting groups
100722|NCT01592760|B3|Baseline|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
100723|NCT01592760|B2|Baseline|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
100729|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100730|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100731|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100732|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100733|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100734|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100735|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100736|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100737|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100738|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100739|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100740|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100741|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100742|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100743|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100744|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100745|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100746|NCT01592760|O3|Outcome|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
100747|NCT01592760|O2|Outcome|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q: air-Q placement for airway maintenance."
100748|NCT01592760|O1|Outcome|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
100749|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100750|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100751|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100752|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100753|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100754|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100755|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100756|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100757|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100758|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100759|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100760|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100761|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100762|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100763|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100764|NCT01592760|E3|Reported Event|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
100765|NCT01592760|E2|Reported Event|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
100766|NCT01592760|E1|Reported Event|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
100767|NCT01592708|B3|Baseline|Total|Total of all reporting groups
100768|NCT01592708|B2|Baseline|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100769|NCT01592708|B1|Baseline|Intervention Cohort|This arm was managed perioperatively with the protocol.
100770|NCT01592708|P2|Participant Flow|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100771|NCT01592708|P1|Participant Flow|Intervention Cohort|Patients undergoing maxillary surgery using antiemetic anesthesia protocol
100772|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
100773|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
100774|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100775|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
100776|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
100777|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
100778|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100779|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
100780|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100781|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
100782|NCT01592708|E2|Reported Event|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
100783|NCT01592708|E1|Reported Event|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthesia protocol
100784|NCT01592396|B3|Baseline|Total|Total of all reporting groups
100785|NCT01592396|B2|Baseline|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100786|NCT01592396|B1|Baseline|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100787|NCT01592396|P2|Participant Flow|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100788|NCT01592396|P1|Participant Flow|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100789|NCT01592396|O1|Outcome|Tralokinumab 300mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100790|NCT01592396|O1|Outcome|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100791|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100792|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100793|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100794|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100795|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100796|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100797|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100798|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100799|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100800|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
100801|NCT01592396|E1|Reported Event|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
100802|NCT01592344|B3|Baseline|Total|Total of all reporting groups
100803|NCT01592344|B2|Baseline|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
100804|NCT01592344|B1|Baseline|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
100805|NCT01592344|P2|Participant Flow|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
100806|NCT01592344|P1|Participant Flow|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
100807|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100808|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100809|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100810|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100811|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100812|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100813|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100814|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100815|NCT01592344|E2|Reported Event|StimRouter Control|"The stimulation program settings for the control arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100816|NCT01592344|E1|Reported Event|StimRouter Active Stimulation|"The stimulation program settings for the active stimulation arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
100817|NCT01592292|B3|Baseline|Total|Total of all reporting groups
100818|NCT01592292|B2|Baseline|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100819|NCT01592292|B1|Baseline|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100820|NCT01592292|P4|Participant Flow|Other Anti-TNF Agent: Infliximab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician’s discretion for RA treatment were observed for 12 months.
100821|NCT01592292|P3|Participant Flow|Other Anti-TNF Agent: Etanercept|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician’s discretion for RA treatment were observed for 12 months.
100822|NCT01592292|P2|Participant Flow|Other Anti-TNF Agent: Adalimumab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician’s discretion for RA treatment were observed for 12 months.
100823|NCT01592292|P1|Participant Flow|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100963|NCT01591616|O25|Outcome|Vital Signs (Diastolic), 220 Minutes Post-dose|
100824|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100825|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100826|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100827|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100828|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100829|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100830|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100831|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100832|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100833|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100834|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100835|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100836|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100837|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100838|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100839|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100840|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100841|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100842|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100843|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100844|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100845|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100846|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100847|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100848|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100849|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100850|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100851|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100852|NCT01592292|E2|Reported Event|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
100853|NCT01592292|E1|Reported Event|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
100854|NCT01592071|B1|Baseline|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100855|NCT01592071|P1|Participant Flow|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100856|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100857|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100858|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100859|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100860|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100861|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100862|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100863|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100864|NCT01592071|E1|Reported Event|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
100865|NCT01592045|B3|Baseline|Total|Total of all reporting groups
100866|NCT01592045|B2|Baseline|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
100890|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100964|NCT01591616|O24|Outcome|Vital Signs (Diastolic), 210 Minutes Post-dose|
100867|NCT01592045|B1|Baseline|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
100868|NCT01592045|P2|Participant Flow|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
100869|NCT01592045|P1|Participant Flow|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
100870|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
100871|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
100872|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
100873|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
100874|NCT01592045|E2|Reported Event|NCI ch14.18|NCI Manufactured ch14.18
100875|NCT01592045|E1|Reported Event|UTC ch14.18|United Therapeutics Manufactured ch14.18
100876|NCT01592006|B1|Baseline|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
100877|NCT01592006|P1|Participant Flow|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
100878|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
100879|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
100880|NCT01592006|E1|Reported Event|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
100881|NCT01591954|B1|Baseline|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
100882|NCT01591954|P1|Participant Flow|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
100883|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
100884|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
100885|NCT01591954|E1|Reported Event|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
100886|NCT01591863|B1|Baseline|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100887|NCT01591863|P1|Participant Flow|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100888|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100889|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100956|NCT01591616|O1|Outcome|PR Interval, Pre-dose|
100891|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100892|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100893|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100894|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100895|NCT01591863|E1|Reported Event|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
100896|NCT01591837|B3|Baseline|Total|Total of all reporting groups
100897|NCT01591837|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100898|NCT01591837|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100899|NCT01591837|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100900|NCT01591837|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100901|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100902|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100903|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100904|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100905|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100906|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100907|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100908|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100909|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100910|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100911|NCT01591837|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100912|NCT01591837|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
100913|NCT01591681|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
100914|NCT01591681|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
100915|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100916|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100917|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100918|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100919|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100957|NCT01591616|O4|Outcome|Ventricular Heart Rate, 4 Hour Post-dose|
100920|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100921|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100922|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100923|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100924|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100925|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100926|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100927|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100928|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100929|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100930|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100931|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100932|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100933|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100934|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100935|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
100936|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
100937|NCT01591681|E2|Reported Event|Standard of Care|On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
100938|NCT01591681|E1|Reported Event|Pump Suspension Algorithm|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.)
100939|NCT01591616|B1|Baseline|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
100940|NCT01591616|P1|Participant Flow|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
100941|NCT01591616|O4|Outcome|QTcB Interval, 4 Hour Post-dose|
100942|NCT01591616|O3|Outcome|QTcB Interval, 2 Hour Post-dose|
100943|NCT01591616|O2|Outcome|QTcB Interval, 1 Hour Post-dose|
100944|NCT01591616|O1|Outcome|QTcB Interval, Pre-dose|
100945|NCT01591616|O4|Outcome|QT Interval, 4 Hour Post-dose|
100946|NCT01591616|O3|Outcome|QT Interval, 2 Hour Post-dose|
100947|NCT01591616|O2|Outcome|QT Interval, 1 Hour Post-dose|
100948|NCT01591616|O1|Outcome|QT Interval, Pre-dose|
100949|NCT01591616|O4|Outcome|QRS Duration, 4 Hour Post-dose|
100950|NCT01591616|O3|Outcome|QRS Duration, 2 Hour Post-dose|
100951|NCT01591616|O2|Outcome|QRS Duration, 1 Hour Post-dose|
100952|NCT01591616|O1|Outcome|QRS Duration, Pre-dose|
100953|NCT01591616|O4|Outcome|PR Interval, 4 Hour Post-dose|
100954|NCT01591616|O3|Outcome|PR Interval, 2 Hour Post-dose|
100955|NCT01591616|O2|Outcome|PR Interval, 1 Hour Post-dose|
100965|NCT01591616|O23|Outcome|Vital Signs (Diastolic), 200 Minutes Post-dose|
100966|NCT01591616|O22|Outcome|Vital Signs (Diastolic), 190 Minutes Post-dose|
100967|NCT01591616|O21|Outcome|Vital Signs (Diastolic), 180 Minutes Post-dose|
100968|NCT01591616|O20|Outcome|Vital Signs (Diastolic), 170 Minutes Post-dose|
100969|NCT01591616|O19|Outcome|Vital Signs (Diastolic), 160 Minutes Post-dose|
100970|NCT01591616|O18|Outcome|Vital Signs (Diastolic), 150 Minutes Post-dose|
100971|NCT01591616|O17|Outcome|Vital Signs (Diastolic), 140 Minutes Post-dose|
100972|NCT01591616|O16|Outcome|Vital Signs Diastolic(), 130 Minutes Post-dose|
100973|NCT01591616|O15|Outcome|Vital Signs (Diastolic), 120 Minutes Post-dose|
100974|NCT01591616|O14|Outcome|Vital Signs (Diastolic), 110 Minutes Post-dose|
100975|NCT01591616|O13|Outcome|Vital Signs (Diastolic), 100 Minutes Post-dose|
100976|NCT01591616|O12|Outcome|Vital Signs (Diastolic), 90 Minutes Post-dose|
100977|NCT01591616|O11|Outcome|Vital Signs (Diastolic) 80 Minutes Post-dose|
100978|NCT01591616|O10|Outcome|Vital Signs (Diastolic), 70 Minutes Post-dose|
100979|NCT01591616|O9|Outcome|Vital Signs Diastolic(), 60 Minutes Post-dose|
100980|NCT01591616|O8|Outcome|Vital Signs (Diastolic), 50 Minutes Post-dose|
100981|NCT01591616|O7|Outcome|Vital Signs (Diastolic), 40 Minutes Post-dose|
100982|NCT01591616|O6|Outcome|Vital Signs (Diastolic), 30 Minutes Post-dose|
100983|NCT01591616|O5|Outcome|Vital Signs (Diastolic), 20 Minutes Post-dose|
100984|NCT01591616|O4|Outcome|Vital Signs (Diastolic), 10 Minutes Post-dose|
100985|NCT01591616|O3|Outcome|Vital Signs (Diastolic), 0 Minutes Pre-dose|
100986|NCT01591616|O2|Outcome|Vital Signs (Diastolic), - 10 Minutes Pre-dose|
100987|NCT01591616|O1|Outcome|Vital Signs (Diastolic), - 20 Minutes Pre-dose|
100988|NCT01591616|O27|Outcome|Vital Signs (Systolic), 240 Minutes Post-dose|
100989|NCT01591616|O26|Outcome|Vital Signs (Systolic), 230 Minutes Post-dose|
100990|NCT01591616|O25|Outcome|Vital Signs (Systolic), 220 Minutes Post-dose|
100991|NCT01591616|O24|Outcome|Vital Signs (Systolic), 210 Minutes Post-dose|
100992|NCT01591616|O23|Outcome|Vital Signs (Systolic), 200 Minutes Post-dose|
100993|NCT01591616|O22|Outcome|Vital Signs (Systolic), 190 Minutes Post-dose|
100994|NCT01591616|O21|Outcome|Vital Signs (Systolic), 180 Minutes Post-dose|
100995|NCT01591616|O20|Outcome|Vital Signs (Systolic), 170 Minutes Post-dose|
100996|NCT01591616|O19|Outcome|Vital Signs (Systolic), 160 Minutes Post-dose|
100997|NCT01591616|O18|Outcome|Vital Signs (Systolic), 150 Minutes Post-dose|
100998|NCT01591616|O17|Outcome|Vital Signs (Systolic), 140 Minutes Post-dose|
100999|NCT01591616|O16|Outcome|Vital Signs (Systolic), 130 Minutes Post-dose|
101000|NCT01591616|O15|Outcome|Vital Signs (Systolic), 120 Minutes Post-dose|
101001|NCT01591616|O14|Outcome|Vital Signs (Systolic), 110 Minutes Post-dose|
101002|NCT01591616|O13|Outcome|Vital Signs (Systolic), 100 Minutes Post-dose|
101003|NCT01591616|O12|Outcome|Vital Signs (Systolic), 90 Minutes Post-dose|
101004|NCT01591616|O11|Outcome|Vital Signs (Systolic) 80 Minutes Post-dose|
101005|NCT01591616|O10|Outcome|Vital Signs (Systolic), 70 Minutes Post-dose|
101006|NCT01591616|O9|Outcome|Vital Signs (Systolic), 60 Minutes Post-dose|
101007|NCT01591616|O8|Outcome|Vital Signs (Systolic), 50 Minutes Post-dose|
101008|NCT01591616|O7|Outcome|Vital Signs (Systolic), 40 Minutes Post-dose|
101009|NCT01591616|O6|Outcome|Vital Signs (Systolic), 30 Minutes Post-dose|
101010|NCT01591616|O5|Outcome|Vital Signs (Systolic), 20 Minutes Post-dose|
101011|NCT01591616|O4|Outcome|Vital Signs (Systolic), 10 Minutes Post-dose|
101012|NCT01591616|O3|Outcome|Vital Signs (Systolic), 0 Minutes Pre-dose|
101013|NCT01591616|O2|Outcome|Vital Signs (Systolic), - 10 Minutes Pre-dose|
101014|NCT01591616|O1|Outcome|Vital Signs (Systolic), - 20 Minutes Pre-dose|
101015|NCT01591616|O27|Outcome|Vital Signs (Pulse Rate), 240 Minutes Post-dose|
101016|NCT01591616|O26|Outcome|Vital Signs (Pulse Rate), 230 Minutes Post-dose|
101017|NCT01591616|O25|Outcome|Vital Signs (Pulse Rate), 220 Minutes Post-dose|
101018|NCT01591616|O24|Outcome|Vital Signs (Pulse Rate), 210 Minutes Post-dose|
101019|NCT01591616|O23|Outcome|Vital Signs (Pulse Rate), 200 Minutes Post-dose|
101020|NCT01591616|O22|Outcome|Vital Signs (Pulse Rate), 190 Minutes Post-dose|
101021|NCT01591616|O21|Outcome|Vital Signs (Pulse Rate), 180 Minutes Post-dose|
101022|NCT01591616|O20|Outcome|Vital Signs (Pulse Rate), 170 Minutes Post-dose|
101023|NCT01591616|O19|Outcome|Vital Signs (Pulse Rate), 160 Minutes Post-dose|
101024|NCT01591616|O18|Outcome|Vital Signs (Pulse Rate), 150 Minutes Post-dose|
101025|NCT01591616|O17|Outcome|Vital Signs (Pulse Rate), 140 Minutes Post-dose|
101026|NCT01591616|O16|Outcome|Vital Signs (Pulse Rate), 130 Minutes Post-dose|
101027|NCT01591616|O15|Outcome|Vital Signs (Pulse Rate), 120 Minutes Post-dose|
101028|NCT01591616|O14|Outcome|Vital Signs (Pulse Rate), 110 Minutes Post-dose|
101029|NCT01591616|O13|Outcome|Vital Signs (Pulse Rate), 100 Minutes Post-dose|
101030|NCT01591616|O12|Outcome|Vital Signs (Pulse Rate), 90 Minutes Post-dose|
101031|NCT01591616|O11|Outcome|Vital Signs (Pulse Rate), 80 Minutes Post-dose|
101032|NCT01591616|O10|Outcome|Vital Signs (Pulse Rate), 70 Minutes Post-dose|
101033|NCT01591616|O9|Outcome|Vital Signs (Pulse Rate), 60 Minutes Post-dose|
101034|NCT01591616|O8|Outcome|Vital Signs (Pulse Rate), 50 Minutes Post-dose|
101035|NCT01591616|O7|Outcome|Vital Signs (Pulse Rate), 40 Minutes Post-dose|
101036|NCT01591616|O6|Outcome|Vital Signs (Pulse Rate), 30 Minutes Post-dose|
101037|NCT01591616|O5|Outcome|Vital Signs (Pulse Rate), 20 Minutes Post-dose|
101038|NCT01591616|O4|Outcome|Vital Signs (Pulse Rate), 10 Minutes Post-dose|
101039|NCT01591616|O3|Outcome|Vital Signs (Pulse Rate), 0 Minutes Pre-dose|
101040|NCT01591616|O2|Outcome|Vital Signs (Pulse Rate), - 10 Minutes Pre-dose|
101041|NCT01591616|O1|Outcome|Vital Signs (Pulse Rate), - 20 Minutes Pre-dose|
101042|NCT01591616|O4|Outcome|O-toluidine Tmax|
101043|NCT01591616|O3|Outcome|2,6-xylidine Tmax|
101044|NCT01591616|O2|Outcome|Prilocaine Tmax|
101045|NCT01591616|O1|Outcome|Lidocaine Tmax|
101046|NCT01591616|O27|Outcome|% MetHemoglobin (MetHb) Time Point 240 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101047|NCT01591616|O26|Outcome|% MetHemoglobin (MetHb) Time Point 230 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101048|NCT01591616|O25|Outcome|% MetHemoglobin (MetHb) Time Point 220 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101049|NCT01591616|O24|Outcome|% MetHemoglobin (MetHb) Time Point 210 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101050|NCT01591616|O23|Outcome|% MetHemoglobin (MetHb) Time Point 200 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101051|NCT01591616|O22|Outcome|% MetHemoglobin (MetHb) Time Point 190 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101052|NCT01591616|O21|Outcome|% MetHemoglobin (MetHb) Time Point 180 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101053|NCT01591616|O20|Outcome|% MetHemoglobin (MetHb) Time Point 170 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101054|NCT01591616|O19|Outcome|% MetHemoglobin (MetHb) Time Point 160 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101055|NCT01591616|O18|Outcome|% MetHemoglobin (MetHb) Time Point 150 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101056|NCT01591616|O17|Outcome|% MetHemoglobin (MetHb) Time Point 140 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101057|NCT01591616|O16|Outcome|% MetHemoglobin (MetHb) Time Point 130 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101058|NCT01591616|O15|Outcome|% MetHemoglobin (MetHb) Time Point 120 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101059|NCT01591616|O14|Outcome|% MetHemoglobin (MetHb) Time Point 110 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101060|NCT01591616|O13|Outcome|% MetHemoglobin (MetHb) Time Point 100 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101061|NCT01591616|O12|Outcome|% MetHemoglobin (MetHb) Time Point 90 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101062|NCT01591616|O11|Outcome|% MetHemoglobin (MetHb) Time Point 80 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101063|NCT01591616|O10|Outcome|% MetHemoglobin (MetHb) Time Point 70 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101064|NCT01591616|O9|Outcome|% MetHemoglobin (MetHb) Time Point 60 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101065|NCT01591616|O8|Outcome|% MetHemoglobin (MetHb) Time Point 50 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101066|NCT01591616|O7|Outcome|% MetHemoglobin (MetHb) Time Point 40 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101067|NCT01591616|O6|Outcome|% MetHemoglobin (MetHb) Time Point 30 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101068|NCT01591616|O5|Outcome|% MetHemoglobin (MetHb) Time Point 20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101069|NCT01591616|O4|Outcome|% MetHemoglobin (MetHb) Time Point 10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101070|NCT01591616|O3|Outcome|% MetHemoglobin (MetHb) Time Point 0 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101071|NCT01591616|O2|Outcome|% MetHemoglobin (MetHb) Time Point -10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101072|NCT01591616|O1|Outcome|% MetHemoglobin (MetHb) Time Point -20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
101073|NCT01591616|O4|Outcome|O-toluidine Cmax|
101074|NCT01591616|O3|Outcome|2,6-xylidine Cmax|
101075|NCT01591616|O2|Outcome|Prilocaine Cmax|
101076|NCT01591616|O1|Outcome|Lidocaine Cmax|
101077|NCT01591616|E1|Reported Event|Adverse Events|
101078|NCT01591499|B3|Baseline|Total|Total of all reporting groups
101121|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101079|NCT01591499|B2|Baseline|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity)
101080|NCT01591499|B1|Baseline|Biofinity/Air Optix Aqua Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity)
101081|NCT01591499|P4|Participant Flow|Purevision Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
101082|NCT01591499|P3|Participant Flow|Biofinity Then Purevision|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
101083|NCT01591499|P2|Participant Flow|Air Optix Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
101084|NCT01591499|P1|Participant Flow|Biofinity Then Air Optix|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
101085|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair
101086|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
101087|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
101088|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair.
101089|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
101090|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
101091|NCT01591499|O3|Outcome|Purevision Multifocal|Clinical performance by lens (Purevision Multifocal)
101092|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Clinical performance by lens (Air Optix Aqua Multifocal)
101093|NCT01591499|O1|Outcome|Biofinity Multifocal|Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5
101094|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
101095|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
101096|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
101097|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
101098|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
101099|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
101100|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
101101|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
101102|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
101103|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
101104|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
101105|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
101106|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
101107|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
101108|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
101109|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
101110|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
101111|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
101112|NCT01591499|O3|Outcome|Purevision Multifocal|Comfort performance by lens (Purevision Multifocal)
101113|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Comfort performance by lens (Air Optix Aqua Multifocal)
101114|NCT01591499|O1|Outcome|Biofinity Multifocal|Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5
101115|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101116|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101117|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101118|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101119|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101120|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101122|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101123|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101124|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101125|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101126|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
101127|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101128|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101129|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101130|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101131|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101132|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101133|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101134|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101135|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101136|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101137|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101138|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
101139|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101140|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101141|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
101142|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101143|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101144|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal)
101145|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
101146|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
101147|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
101148|NCT01591499|E1|Reported Event|Overall Study Population|Population of patients having evaluated at least one lens
101149|NCT01591460|B1|Baseline|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101150|NCT01591460|P1|Participant Flow|Total Population|Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101151|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101152|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101266|NCT01591317|E3|Reported Event|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
101267|NCT01591317|E2|Reported Event|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
101352|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101153|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101154|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101155|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101156|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101157|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101158|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101159|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101160|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101161|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101162|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101268|NCT01591317|E1|Reported Event|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
101269|NCT01591044|B4|Baseline|Total|Total of all reporting groups
101270|NCT01591044|B3|Baseline|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101163|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101164|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101165|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101166|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101167|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101168|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101169|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101170|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101171|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101172|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101173|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101271|NCT01591044|B2|Baseline|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
101431|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101174|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101175|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101176|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101177|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101178|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101179|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101180|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101181|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101182|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101183|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101184|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101272|NCT01591044|B1|Baseline|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101273|NCT01591044|P3|Participant Flow|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101185|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101186|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101187|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101188|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101189|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101190|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101191|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101192|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101193|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101194|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101195|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101274|NCT01591044|P2|Participant Flow|Placebo|Placebo: 1 puff bid or 2 puffs bid
101275|NCT01591044|P1|Participant Flow|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101276|NCT01591044|O3|Outcome|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101277|NCT01591044|O2|Outcome|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
101196|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101197|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101198|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101199|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101200|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101201|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101202|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101203|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101204|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101205|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101206|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101278|NCT01591044|O1|Outcome|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101207|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101208|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101209|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101210|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101211|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101212|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101213|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101214|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101215|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101216|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101217|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101279|NCT01591044|E3|Reported Event|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101280|NCT01591044|E2|Reported Event|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
101218|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101219|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101220|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101221|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
101222|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
101223|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
101224|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
101225|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
101226|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
101227|NCT01591460|E2|Reported Event|Noncirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
101281|NCT01591044|E1|Reported Event|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
101282|NCT01591018|B3|Baseline|Total|Total of all reporting groups
101283|NCT01591018|B2|Baseline|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101228|NCT01591460|E1|Reported Event|Cirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.
101229|NCT01591408|B3|Baseline|Total|Total of all reporting groups
101230|NCT01591408|B2|Baseline|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101231|NCT01591408|B1|Baseline|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101232|NCT01591408|P2|Participant Flow|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101233|NCT01591408|P1|Participant Flow|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101234|NCT01591408|O2|Outcome|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101235|NCT01591408|O1|Outcome|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101236|NCT01591408|E2|Reported Event|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101237|NCT01591408|E1|Reported Event|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
101238|NCT01591317|B4|Baseline|Total|Total of all reporting groups
101239|NCT01591317|B3|Baseline|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
101240|NCT01591317|B2|Baseline|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
101241|NCT01591317|B1|Baseline|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
101242|NCT01591317|P3|Participant Flow|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
101243|NCT01591317|P2|Participant Flow|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
101244|NCT01591317|P1|Participant Flow|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
101245|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
101246|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
101247|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
101248|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
101249|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
101250|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
101251|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
101252|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
101253|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
101254|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
101255|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
101256|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
101257|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
101258|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
101259|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
101260|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
101261|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
101262|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
101263|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
101264|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
101265|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
101284|NCT01591018|B1|Baseline|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101285|NCT01591018|P2|Participant Flow|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101286|NCT01591018|P1|Participant Flow|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101287|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101288|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101289|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101290|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101291|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101292|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101293|NCT01591018|E2|Reported Event|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101294|NCT01591018|E1|Reported Event|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
101295|NCT01591005|B5|Baseline|Total|Total of all reporting groups
101296|NCT01591005|B4|Baseline|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101297|NCT01591005|B3|Baseline|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101298|NCT01591005|B2|Baseline|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101299|NCT01591005|B1|Baseline|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101300|NCT01591005|P4|Participant Flow|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101301|NCT01591005|P3|Participant Flow|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101302|NCT01591005|P2|Participant Flow|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101303|NCT01591005|P1|Participant Flow|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101304|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101305|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101306|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101307|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101308|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101309|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101310|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101311|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101312|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101432|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101313|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101314|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101315|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101316|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101317|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101318|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101319|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101320|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101321|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101322|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101323|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101324|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101325|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101326|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101327|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101328|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101329|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101330|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101331|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101332|NCT01591005|E4|Reported Event|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
101333|NCT01591005|E3|Reported Event|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
101334|NCT01591005|E2|Reported Event|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
101335|NCT01591005|E1|Reported Event|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
101336|NCT01590888|B4|Baseline|Total|Total of all reporting groups
101337|NCT01590888|B3|Baseline|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101338|NCT01590888|B2|Baseline|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101339|NCT01590888|B1|Baseline|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101340|NCT01590888|P3|Participant Flow|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101341|NCT01590888|P2|Participant Flow|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101342|NCT01590888|P1|Participant Flow|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101343|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101344|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101345|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101346|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101347|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101348|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101349|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101350|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101351|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101353|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101354|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101355|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101356|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101357|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101358|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101359|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101360|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101361|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101362|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101363|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101364|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101365|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101366|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101367|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101368|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101369|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101370|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101371|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101372|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101373|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101374|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101375|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101376|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101377|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101378|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101379|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101380|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101381|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101382|NCT01590888|E3|Reported Event|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
101383|NCT01590888|E2|Reported Event|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
101384|NCT01590888|E1|Reported Event|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
101385|NCT01590810|B6|Baseline|Total|Total of all reporting groups
101386|NCT01590810|B5|Baseline|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
101387|NCT01590810|B4|Baseline|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
101388|NCT01590810|B3|Baseline|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
101389|NCT01590810|B2|Baseline|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
101390|NCT01590810|B1|Baseline|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
101433|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101391|NCT01590810|P5|Participant Flow|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
101392|NCT01590810|P4|Participant Flow|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
101393|NCT01590810|P3|Participant Flow|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
101394|NCT01590810|P2|Participant Flow|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
101395|NCT01590810|P1|Participant Flow|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
101396|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101397|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101398|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101399|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101400|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101401|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101402|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101403|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101404|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101405|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101406|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101407|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101408|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101409|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101410|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101411|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101412|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101413|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101414|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101415|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101416|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101417|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101418|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101419|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101420|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101421|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101422|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101423|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101424|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101425|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101426|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101427|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101428|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101429|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101430|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101434|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101435|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101436|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101437|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101438|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101439|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101440|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101441|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101442|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101443|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101444|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101445|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101446|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101447|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101448|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101449|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101450|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101451|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101452|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101453|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101454|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101455|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101456|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101457|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101458|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101459|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101460|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101461|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101462|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101463|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101464|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101465|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101466|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101467|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101468|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101469|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101470|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101471|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101472|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101473|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101474|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101475|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101476|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101477|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101478|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101479|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101480|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101481|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101482|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101483|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101484|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101485|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101486|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101487|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101488|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101489|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101490|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101491|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101492|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101493|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101494|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101495|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101496|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101497|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101498|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101499|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101500|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101501|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
101502|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
101503|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
101504|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
101505|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
101506|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
101507|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
101508|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
101509|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
101510|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
101511|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
101512|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
101513|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
101514|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
101515|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
101516|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
101517|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
101518|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
101519|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
101520|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
101521|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
101522|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
101523|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
101524|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
101525|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
101526|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
101527|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
101569|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101528|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
101529|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
101530|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
101531|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
101532|NCT01590810|E5|Reported Event|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
101533|NCT01590810|E4|Reported Event|Panel D – MK-8150 50 to 200 mg|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
101534|NCT01590810|E3|Reported Event|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
101535|NCT01590810|E2|Reported Event|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
101536|NCT01590810|E1|Reported Event|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
101537|NCT01590797|B3|Baseline|Total|Total of all reporting groups
101538|NCT01590797|B2|Baseline|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101539|NCT01590797|B1|Baseline|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101540|NCT01590797|P2|Participant Flow|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101541|NCT01590797|P1|Participant Flow|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101617|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
101542|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101543|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101544|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101545|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101546|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101547|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101548|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101549|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101550|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101551|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101552|NCT01590797|E2|Reported Event|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101553|NCT01590797|E1|Reported Event|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
101554|NCT01590771|B3|Baseline|Total|Total of all reporting groups
101555|NCT01590771|B2|Baseline|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101556|NCT01590771|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101557|NCT01590771|P2|Participant Flow|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101558|NCT01590771|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101559|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101560|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101561|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101562|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101563|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101564|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101565|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101566|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101567|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101568|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101652|NCT01589822|B2|Baseline|Standard of Care|Standard surgical technique for GI anastomosis.
101570|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101571|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101572|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101573|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101574|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101575|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101576|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101577|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101578|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101579|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101580|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101581|NCT01590771|E2|Reported Event|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101582|NCT01590771|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
101583|NCT01590563|B1|Baseline|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
101584|NCT01590563|P1|Participant Flow|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
101585|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
101586|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
101587|NCT01590563|O1|Outcome|Investigated Device Group|Group inserted the investigated device - the IUB SCu300A
101588|NCT01590563|E1|Reported Event|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
101589|NCT01590550|B1|Baseline|Observational|All patients receiving acute HD during the study period
101590|NCT01590550|P1|Participant Flow|Observational|All patients receiving acute HD during the study period
101591|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
101592|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period
101593|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
101594|NCT01590550|E1|Reported Event|Observational|All patients receiving acute HD during the study period
101595|NCT01590264|B1|Baseline|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
101596|NCT01590264|P1|Participant Flow|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
101597|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
101598|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
101651|NCT01589822|B3|Baseline|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
101599|NCT01590264|E1|Reported Event|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
101600|NCT01590238|B1|Baseline|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
101601|NCT01590238|P1|Participant Flow|Treatment With PRFM|"Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
101602|NCT01590238|O1|Outcome|Treatment With PRFM|Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
101603|NCT01590238|E1|Reported Event|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
101604|NCT01590212|B4|Baseline|Total|Total of all reporting groups
101605|NCT01590212|B3|Baseline|Care as Usual (CAU)|Participants received care in line with local guidelines.
101606|NCT01590212|B2|Baseline|Chill-out in Pregnancy (CHiP) + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101607|NCT01590212|B1|Baseline|Mellow Bumps (MB) + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers’ understanding of neonates’ capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks’ gestation.
101608|NCT01590212|P3|Participant Flow|Care as Usual|"Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines.~Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks."
101609|NCT01590212|P2|Participant Flow|Chill-out in Pregnancy + Care as Usual|"Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs.~It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
101610|NCT01590212|P1|Participant Flow|Mellow Bumps + Care as Usual|"Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs.~Underpinned by attachment theory, there is a focus on:~Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
101611|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
101612|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101613|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
101614|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
101615|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101616|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
101618|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101619|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
101620|NCT01590212|O3|Outcome|Care as Usual|All participants received care in line with local guidelines.
101621|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101622|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
101623|NCT01590212|E3|Reported Event|Care as Usual|Participants received care in line with local guidelines
101624|NCT01590212|E2|Reported Event|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
101625|NCT01590212|E1|Reported Event|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
101626|NCT01589978|B1|Baseline|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101627|NCT01589978|P1|Participant Flow|PROMUS Element Overall Population|"Subjects who receive the PROMUS Element everolimus-eluting coronary stent.~Subgroups within the Overall Population Group:~PLATINUM-Like Patients N=776 (at time of Primary endpoint)~Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.~Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent."
101628|NCT01589978|O1|Outcome|PROMUS Element Overall Population|Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
101629|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101630|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101631|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101632|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101633|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101634|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101635|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101636|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101637|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101638|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101639|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101640|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101641|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101642|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101643|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101644|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101645|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101646|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101647|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101648|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101649|NCT01589978|E1|Reported Event|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
101650|NCT01589822|B4|Baseline|Total|Total of all reporting groups
101653|NCT01589822|B1|Baseline|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
101654|NCT01589822|P3|Participant Flow|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
101655|NCT01589822|P2|Participant Flow|Standard of Care|Standard surgical technique for GI anastomosis.
101656|NCT01589822|P1|Participant Flow|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
101657|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101658|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
101659|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101660|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101661|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
101662|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101663|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101664|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
101665|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101666|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101667|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (IIT)
101668|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (IIT)"
101669|NCT01589822|E3|Reported Event|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101670|NCT01589822|E2|Reported Event|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
101671|NCT01589822|E1|Reported Event|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
101672|NCT01589653|B3|Baseline|Total|Total of all reporting groups
101673|NCT01589653|B2|Baseline|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101674|NCT01589653|B1|Baseline|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101675|NCT01589653|P2|Participant Flow|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101676|NCT01589653|P1|Participant Flow|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101677|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101678|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101679|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101680|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101681|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101682|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101683|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101684|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101849|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
101685|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101686|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101687|NCT01589653|E2|Reported Event|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101688|NCT01589653|E1|Reported Event|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
101689|NCT01589510|B1|Baseline|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101690|NCT01589510|P1|Participant Flow|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101691|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101692|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101693|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101694|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101695|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101696|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101697|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101698|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101699|NCT01589510|E1|Reported Event|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
101700|NCT01589484|B1|Baseline|Shockwave Lithotripsy (SWL)|One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
101701|NCT01589484|P1|Participant Flow|Shockwave Lithotripsy (SWL)|All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
101702|NCT01589484|O1|Outcome|SWL Complications|Shock wave lithotripsy complications
101703|NCT01589484|O1|Outcome|Primary Endoint|Shock wave lithotripsy outcome
101704|NCT01589484|E1|Reported Event|Shockwave Lithotripsy (SWL)|All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
101705|NCT01589445|B1|Baseline|Single Group Study With Two Interventions|"This was double blind, single group and within subjects designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.~For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder."
101706|NCT01589445|P1|Participant Flow|Single Group Study With Two Drugs- Pioglitazone and Metformin|"Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily~The single group study with a wash out period of one month with metformin 850 mg tablet once daily.~77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).~48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group]."
101707|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101708|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
101709|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101710|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
101711|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101712|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
101713|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101714|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
101715|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101716|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30mg once daily for 3 months.
101717|NCT01589445|O2|Outcome|Metformin (002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
101718|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
101719|NCT01589445|E2|Reported Event|Metformin (002 Group)|"After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.~On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.~One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression."
101720|NCT01589445|E1|Reported Event|Pioglitazone (001 Group)|"77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.~No serious adverse event was found during pioglitazone trial.~In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them."
101721|NCT01589237|B5|Baseline|Total|Total of all reporting groups
101722|NCT01589237|B4|Baseline|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101723|NCT01589237|B3|Baseline|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101724|NCT01589237|B2|Baseline|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101725|NCT01589237|B1|Baseline|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101726|NCT01589237|P4|Participant Flow|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101727|NCT01589237|P3|Participant Flow|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101728|NCT01589237|P2|Participant Flow|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101729|NCT01589237|P1|Participant Flow|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
101815|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101730|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101731|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101732|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101733|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101734|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101735|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101736|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101737|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101738|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101739|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101740|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101741|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101742|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101743|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101744|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101745|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101746|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101747|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101748|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101816|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101817|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101749|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101750|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101751|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101752|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101753|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101754|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101755|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101756|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101757|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101758|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101759|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101760|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101761|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101762|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101763|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101764|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101765|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101766|NCT01589237|E8|Reported Event|Part B-40 mg Pradigastat (LCQ908)|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
101767|NCT01589237|E7|Reported Event|Part B- Pradigastat (LCQ908) Regimen- From Study A2212|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
101818|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101768|NCT01589237|E6|Reported Event|Part B-20mg Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
101769|NCT01589237|E5|Reported Event|Part B-placebo of Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
101770|NCT01589237|E4|Reported Event|Part A: Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101771|NCT01589237|E3|Reported Event|Part A-40mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101772|NCT01589237|E2|Reported Event|Part A-20mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101773|NCT01589237|E1|Reported Event|Part A-placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
101774|NCT01588548|B7|Baseline|Total|Total of all reporting groups
101775|NCT01588548|B6|Baseline|AZD1208 800mg|Once daily continuous dosing schedule.
101776|NCT01588548|B5|Baseline|AZD1208 700mg|Once daily continuous dosing schedule.
101777|NCT01588548|B4|Baseline|AZD1208 540mg|Once daily continuous dosing schedule.
101778|NCT01588548|B3|Baseline|AZD1208 360mg|Once daily continuous dosing schedule.
101779|NCT01588548|B2|Baseline|AZD1208 240mg|Once daily continuous dosing schedule.
101780|NCT01588548|B1|Baseline|AZD1208 120mg|Once daily continuous dosing schedule.
101781|NCT01588548|P6|Participant Flow|AZD1208 800mg|Once daily continuous dosing schedule.
101782|NCT01588548|P5|Participant Flow|AZD1208 700mg|Once daily continuous dosing schedule.
101783|NCT01588548|P4|Participant Flow|AZD1208 540mg|Once daily continuous dosing schedule.
101784|NCT01588548|P3|Participant Flow|AZD1208 360mg|Once daily continuous dosing schedule.
101785|NCT01588548|P2|Participant Flow|AZD1208 240mg|Once daily continuous dosing schedule.
101786|NCT01588548|P1|Participant Flow|AZD1208 120mg|Once daily continuous dosing schedule.
101787|NCT01588548|O6|Outcome|AZD1208 800mg|Once daily continuous dosing schedule.
101788|NCT01588548|O5|Outcome|AZD1208 700mg|Once daily continuous dosing schedule.
101789|NCT01588548|O4|Outcome|AZD1208 540mg|Once daily continuous dosing schedule.
101790|NCT01588548|O3|Outcome|AZD1208 360mg|Once daily continuous dosing schedule.
101791|NCT01588548|O2|Outcome|AZD1208 240mg|Once daily continuous dosing schedule.
101792|NCT01588548|O1|Outcome|AZD1208 120mg|Once daily continuous dosing schedule.
101793|NCT01588548|E6|Reported Event|AZD1208 800mg|Once daily continuous dosing schedule.
101794|NCT01588548|E5|Reported Event|AZD1208 700mg|Once daily continuous dosing schedule.
101795|NCT01588548|E4|Reported Event|AZD1208 540mg|Once daily continuous dosing schedule.
101796|NCT01588548|E3|Reported Event|AZD1208 360mg|Once daily continuous dosing schedule.
101797|NCT01588548|E2|Reported Event|AZD1208 240mg|Once daily continuous dosing schedule.
101798|NCT01588548|E1|Reported Event|AZD1208 120mg|Once daily continuous dosing schedule.
101799|NCT01588496|B4|Baseline|Total|Total of all reporting groups
101800|NCT01588496|B3|Baseline|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101801|NCT01588496|B2|Baseline|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101802|NCT01588496|B1|Baseline|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101803|NCT01588496|P3|Participant Flow|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101804|NCT01588496|P2|Participant Flow|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101805|NCT01588496|P1|Participant Flow|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101806|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101807|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101808|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101809|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101810|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101811|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101812|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101813|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
101814|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101819|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101820|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101821|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101822|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101823|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101824|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101825|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
101826|NCT01588496|E3|Reported Event|Part B: DB Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
101827|NCT01588496|E2|Reported Event|Part B: DB Placebo|Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks.
101828|NCT01588496|E1|Reported Event|Part A: OL Evolocumab|Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks.
101829|NCT01588444|B3|Baseline|Total|Total of all reporting groups
101830|NCT01588444|B2|Baseline|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
101831|NCT01588444|B1|Baseline|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
101832|NCT01588444|P2|Participant Flow|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
101833|NCT01588444|P1|Participant Flow|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
101834|NCT01588444|O2|Outcome|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
101835|NCT01588444|O1|Outcome|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
101836|NCT01588444|E2|Reported Event|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
101837|NCT01588444|E1|Reported Event|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
101838|NCT01588405|B1|Baseline|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101839|NCT01588405|P1|Participant Flow|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101840|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101841|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101842|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101843|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101844|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101845|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101846|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
101847|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
101848|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
101850|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
101851|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
101852|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
101853|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
101854|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
101855|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101856|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101857|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101858|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101859|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101860|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101861|NCT01588405|E1|Reported Event|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
101862|NCT01588353|B4|Baseline|Total|Total of all reporting groups
101863|NCT01588353|B3|Baseline|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101864|NCT01588353|B2|Baseline|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101865|NCT01588353|B1|Baseline|AK160 0.58 mg Step 1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101866|NCT01588353|P3|Participant Flow|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101867|NCT01588353|P2|Participant Flow|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101868|NCT01588353|P1|Participant Flow|AK160 0.58 mg Step1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
101869|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
102127|NCT01587079|E6|Reported Event|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
101870|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
101871|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
101872|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
101873|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
101874|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
101875|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
101876|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
101877|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
101878|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
101879|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
101880|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
101881|NCT01588353|O1|Outcome|AK160 0.58 mg Step 1-2|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
101882|NCT01588353|E1|Reported Event|AK160 0.58 mg Step 1-3|Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
101883|NCT01588158|B3|Baseline|Total|Total of all reporting groups
101884|NCT01588158|B2|Baseline|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101885|NCT01588158|B1|Baseline|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101886|NCT01588158|P2|Participant Flow|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101887|NCT01588158|P1|Participant Flow|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101888|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101889|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101890|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101891|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101892|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101893|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101894|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101895|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101896|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101897|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101898|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101899|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101900|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101901|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101902|NCT01588158|E2|Reported Event|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
101903|NCT01588158|E1|Reported Event|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
101904|NCT01587989|B3|Baseline|Total|Total of all reporting groups
101905|NCT01587989|B2|Baseline|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101906|NCT01587989|B1|Baseline|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101907|NCT01587989|P3|Participant Flow|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101908|NCT01587989|P2|Participant Flow|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101909|NCT01587989|P1|Participant Flow|All Participants|Participants received TCZ 8 milligrams per kilogram (mg/kg), intravenously (IV), every 4 weeks, from Weeks 1-12. Participants also received MTX 15 milligrams per week (mg/week) to 25 mg/week at a stable dose, orally (PO) as tablets, once per week, from Weeks 1-12. Participants also received folic acid, greater than or equal to (≥) 5 mg/week, PO, from Weeks 1-12. Participants also received non-sterioidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to [≤] 10 milligrams per day [mg/day] prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-12. At Week 12 participants who had achieved a good or moderate European League Against Rheumatism (EULAR) response were randomized to receive TCZ plus (+) continued MTX treatment or TCZ + placebo. Participants without a good or moderate EULAR response were excluded from the study and treated according to the standard of care of the treatment site.
101910|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101911|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101912|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101913|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101914|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101915|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101916|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101951|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101952|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101917|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101918|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101919|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101920|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101921|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101922|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101923|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101924|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101925|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101926|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101927|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101928|NCT01587989|E2|Reported Event|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101929|NCT01587989|E1|Reported Event|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
101930|NCT01587950|B1|Baseline|Overall|All randomized participants received all study treatments during this cross over study design.
101931|NCT01587950|P1|Participant Flow|Overall|There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
101932|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
101933|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101934|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101935|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
101936|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101937|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101938|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
101939|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
101940|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
101941|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
101942|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101943|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
101944|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
101945|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101946|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101947|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
101948|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
101949|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
101950|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
101953|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
101954|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101955|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
101956|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
101957|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
101958|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
101959|NCT01587950|E1|Reported Event|Overall|All participants received all study treatments during this cross over study design.
101960|NCT01587885|B1|Baseline|All Participants|All participants who were randomized and received study drug.
101961|NCT01587885|P2|Participant Flow|Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
101962|NCT01587885|P1|Participant Flow|Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
101963|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
101964|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
101965|NCT01587885|O1|Outcome|All Treated Participants|
101966|NCT01587885|O1|Outcome|All Treated Participants|
101967|NCT01587885|O1|Outcome|All Treated Participants|
101968|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
101969|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
101970|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
101971|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
101972|NCT01587885|E2|Reported Event|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
101973|NCT01587885|E1|Reported Event|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
101974|NCT01587651|B4|Baseline|Total|Total of all reporting groups
101975|NCT01587651|B3|Baseline|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
101976|NCT01587651|B2|Baseline|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
101977|NCT01587651|B1|Baseline|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
101978|NCT01587651|P3|Participant Flow|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
101979|NCT01587651|P2|Participant Flow|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
101980|NCT01587651|P1|Participant Flow|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
101981|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
101982|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
101983|NCT01587651|O2|Outcome|Ticagrelor|
101984|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
101985|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
101986|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
101987|NCT01587651|O2|Outcome|Ticagrelor|
101988|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
101989|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
101990|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
101991|NCT01587651|O2|Outcome|Ticagrelor|
101992|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
101993|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
101994|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
101995|NCT01587651|O2|Outcome|Ticagrelor|
101996|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
101997|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
101998|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
101999|NCT01587651|O2|Outcome|Ticagrelor|
102000|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
102001|NCT01587651|O2|Outcome|Ticagrelor|
102002|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
102003|NCT01587651|E3|Reported Event|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
102004|NCT01587651|E2|Reported Event|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
102005|NCT01587651|E1|Reported Event|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
102006|NCT01587118|B1|Baseline|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
102007|NCT01587118|P1|Participant Flow|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
102008|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
102009|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
102010|NCT01587118|E1|Reported Event|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
102011|NCT01587079|B1|Baseline|All Subjects Screened|
102012|NCT01587079|P1|Participant Flow|All Subjects|
102013|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102014|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
102015|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
102016|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
102017|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg BID|4.6/9.6 μg BID
102018|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
102019|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
102020|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
102021|NCT01587079|O8|Outcome|Spiriva18 μg QD|18 μg QD
102022|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
102023|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
102024|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
102025|NCT01587079|O4|Outcome|GFF MDI 4.6/9.6 μg BID|4.6/9.6 μg BID
102026|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
102027|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
102028|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
102029|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102030|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
102031|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
102032|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
102033|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
102034|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
102035|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
102036|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
102037|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102038|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
102039|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
102040|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
102041|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
102042|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
102043|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
102044|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
102045|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102046|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
102047|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
102048|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
102049|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
102050|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
102051|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
102052|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
102053|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102054|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
102055|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
102056|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
102057|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
102058|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
102059|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
102060|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
102061|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
102062|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
102063|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
102064|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
102065|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
102066|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
102067|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
102128|NCT01587079|E5|Reported Event|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
102129|NCT01587079|E4|Reported Event|GFF MDI 4.6/9.6 μg (PT003)|4.6/9.6 μg
102130|NCT01587079|E3|Reported Event|GFF MDI 9/9.6 μg (PT003)|9/9.6 μg
102131|NCT01587079|E2|Reported Event|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
102132|NCT01587079|E1|Reported Event|GP MDI 18 μg (PT001)|18 μg
102133|NCT01587027|B3|Baseline|Total|Total of all reporting groups
102134|NCT01587027|B2|Baseline|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
102135|NCT01587027|B1|Baseline|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
102136|NCT01587027|P2|Participant Flow|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
102137|NCT01587027|P1|Participant Flow|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
102138|NCT01587027|O2|Outcome|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
102139|NCT01587027|O1|Outcome|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
102140|NCT01587027|E2|Reported Event|Arm B|Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
102141|NCT01587027|E1|Reported Event|Arm A|Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
102142|NCT01587014|B1|Baseline|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
102143|NCT01587014|P1|Participant Flow|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
102144|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
102145|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
102146|NCT01587014|E1|Reported Event|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
102147|NCT01587001|B3|Baseline|Total|Total of all reporting groups
102148|NCT01587001|B2|Baseline|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
102149|NCT01587001|B1|Baseline|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
102150|NCT01587001|P2|Participant Flow|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
102151|NCT01587001|P1|Participant Flow|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
102152|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
102153|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
102154|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
102155|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
102156|NCT01587001|E2|Reported Event|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
102157|NCT01587001|E1|Reported Event|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
102158|NCT01586975|B4|Baseline|Total|Total of all reporting groups
102159|NCT01586975|B3|Baseline|Aspiring >300 mg|Aspirin >300 mg QD
102160|NCT01586975|B2|Baseline|Aspirin 81 mg|Aspirin 81 mg QD
102161|NCT01586975|B1|Baseline|Clopidogrel 75 mg|Clopidogrel 75 mg QD
102162|NCT01586975|P3|Participant Flow|Aspirin > 300 mg|Aspiring > 300 mg QD
102163|NCT01586975|P2|Participant Flow|Aspirin 81 mg|Aspirin 81 mg QD
102164|NCT01586975|P1|Participant Flow|Clopidogrel 75 mg|Clopidogrel 75 mg QD
102165|NCT01586975|O3|Outcome|Aspirin > 300 mg|open-label Aspirin
102166|NCT01586975|O2|Outcome|Aspirin 81 mg|open label Aspirin
102167|NCT01586975|O1|Outcome|Clopidogrel 75 mg|Clopidogrel 75 mg QD
102168|NCT01586975|E3|Reported Event|Aspirin >300 mg|Aspirin >300 mg QD
102169|NCT01586975|E2|Reported Event|Aspirin 81 mg|Aspirin 81 mg QD
102170|NCT01586975|E1|Reported Event|Clopidogrel 75 mg|Clopidogrel 75 mg QD
102171|NCT01586962|B1|Baseline|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102172|NCT01586962|P1|Participant Flow|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102173|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102174|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102175|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102176|NCT01586962|E1|Reported Event|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
102177|NCT01586897|B3|Baseline|Total|Total of all reporting groups
102178|NCT01586897|B2|Baseline|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
102810|NCT01584518|O2|Outcome|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
102179|NCT01586897|B1|Baseline|Use of Medication Metronome|"Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
102180|NCT01586897|P2|Participant Flow|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed."
102181|NCT01586897|P1|Participant Flow|Use of Medication Metronome|"Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~26 Primary Care Physicians were randomized to Use of Medication Metronome with 2049 patients analyzed."
102182|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102183|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
102184|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102185|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
102186|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102187|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
102188|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102189|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
102190|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102191|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
102192|NCT01586897|E4|Reported Event|Usual Care - Patients|"Patients of PCPs allocated to Usual Care were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
102193|NCT01586897|E3|Reported Event|Use of Medication Metronome - Patients|"Patients of PCPs allocated to the Use of Medication Metronome were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
102194|NCT01586897|E2|Reported Event|Usual Care - PCPs|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
102195|NCT01586897|E1|Reported Event|Use of Medication Metronome - PCPs|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia.
102196|NCT01586806|B4|Baseline|Total|Total of all reporting groups
102197|NCT01586806|B3|Baseline|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102198|NCT01586806|B2|Baseline|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102199|NCT01586806|B1|Baseline|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102200|NCT01586806|P3|Participant Flow|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102230|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102811|NCT01584518|O1|Outcome|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
102201|NCT01586806|P2|Participant Flow|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102202|NCT01586806|P1|Participant Flow|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102203|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102204|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102205|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102206|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102207|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102208|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102209|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102210|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102211|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102212|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102213|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102214|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102215|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102216|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102217|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102218|NCT01586806|E3|Reported Event|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
102219|NCT01586806|E2|Reported Event|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
102220|NCT01586806|E1|Reported Event|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
102221|NCT01586364|B1|Baseline|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102222|NCT01586364|P1|Participant Flow|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102223|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102224|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102225|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102226|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102227|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102228|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102229|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102231|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102232|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102233|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102234|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102235|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102236|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102237|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102238|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102239|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102240|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102241|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102242|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102243|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102244|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102245|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102246|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102247|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102248|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102249|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102250|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102251|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102252|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102253|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102254|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102255|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102256|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102257|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102258|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102259|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102260|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102261|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102262|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102263|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102264|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102265|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102266|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102267|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102268|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102269|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102270|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102271|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102272|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102273|NCT01586364|E1|Reported Event|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
102274|NCT01586338|B1|Baseline|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102812|NCT01584518|E2|Reported Event|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
102275|NCT01586338|P1|Participant Flow|Synvisc|Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102276|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102277|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102278|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102279|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102280|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102281|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102282|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102283|NCT01586338|E1|Reported Event|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
102284|NCT01586312|B3|Baseline|Total|Total of all reporting groups
102285|NCT01586312|B2|Baseline|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102286|NCT01586312|B1|Baseline|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102287|NCT01586312|P2|Participant Flow|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102288|NCT01586312|P1|Participant Flow|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102289|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102290|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102291|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102292|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102293|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102294|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102295|NCT01586312|E2|Reported Event|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
102296|NCT01586312|E1|Reported Event|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
102297|NCT01586026|B1|Baseline|Combined Demographics|Demographics of 171 subjects that contributed to final data analysis
102298|NCT01586026|P3|Participant Flow|Group C|Maintenance flushes at days 57+
102299|NCT01586026|P2|Participant Flow|Group B|Maintenance flushes at days 29-56
102300|NCT01586026|P1|Participant Flow|Group A|Maintenance flushes at days 1-28
102301|NCT01586026|O3|Outcome|Group C|Maintenance flushes at days 57+
102302|NCT01586026|O2|Outcome|Group B|Maintenance flushes at days 29-56
102303|NCT01586026|O1|Outcome|Group A|Maintenance flushes at days 1-28
102304|NCT01586026|E3|Reported Event|Group C|Maintenance flushes at days 57+
102305|NCT01586026|E2|Reported Event|Group B|Maintenance flushes at days 29-56
102306|NCT01586026|E1|Reported Event|Group A|Maintenance flushes at days 1-28
102307|NCT01585987|B3|Baseline|Total|Total of all reporting groups
102308|NCT01585987|B2|Baseline|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
102309|NCT01585987|B1|Baseline|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102310|NCT01585987|P2|Participant Flow|All Best Supportive Care (BSC)|All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
102311|NCT01585987|P1|Participant Flow|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102312|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
102313|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102314|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
102315|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102316|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
102317|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102318|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
102319|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102320|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
102321|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102322|NCT01585987|E3|Reported Event|Non-Active BSC|Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
102323|NCT01585987|E2|Reported Event|Active Best Supportive Care (BSC)|Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization)
102324|NCT01585987|E1|Reported Event|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
102325|NCT01585961|B1|Baseline|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102326|NCT01585961|P1|Participant Flow|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102381|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102327|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102328|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102329|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102330|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102331|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102332|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102333|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102334|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102335|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102336|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102337|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102338|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102339|NCT01585961|E1|Reported Event|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
102340|NCT01585597|B1|Baseline|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
102341|NCT01585597|P1|Participant Flow|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
102342|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
102382|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102343|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
102344|NCT01585597|E1|Reported Event|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
102345|NCT01585584|B1|Baseline|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
102346|NCT01585584|P1|Participant Flow|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
102347|NCT01585584|O1|Outcome|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
102348|NCT01585584|E1|Reported Event|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
102349|NCT01585558|B4|Baseline|Total|Total of all reporting groups
102350|NCT01585558|B3|Baseline|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102351|NCT01585558|B2|Baseline|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102352|NCT01585558|B1|Baseline|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102353|NCT01585558|P3|Participant Flow|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102354|NCT01585558|P2|Participant Flow|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102355|NCT01585558|P1|Participant Flow|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102356|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102357|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102358|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102359|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102360|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102361|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102362|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102363|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102364|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102365|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102366|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102367|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102368|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102369|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102370|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102371|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102372|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102373|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102374|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102375|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102376|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102377|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102378|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102379|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102380|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102383|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102384|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102385|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102386|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102387|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102388|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102389|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102390|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102391|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102392|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102393|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102394|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102395|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102396|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102397|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102398|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102399|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102400|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102401|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102402|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102403|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102404|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102405|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102406|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102407|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102408|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102409|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102410|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102411|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102412|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102413|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102414|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102415|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102416|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102417|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102418|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102419|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102420|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102421|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102422|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102423|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102424|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102425|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102426|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102427|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102428|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102429|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102430|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102431|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102432|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102433|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102434|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102435|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102436|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102437|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102438|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102439|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102440|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102441|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102442|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102443|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102444|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102445|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102446|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102447|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102448|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102449|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102450|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102451|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102452|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102453|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102454|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102455|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102456|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102457|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102458|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102459|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102460|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102461|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102462|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102463|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102464|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102465|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102466|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102467|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102468|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102469|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102470|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102471|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102472|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102473|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102474|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102475|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102476|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102477|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102478|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102479|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102480|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102481|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102482|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102483|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102484|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102485|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102486|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102487|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102488|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102489|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102490|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102491|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102492|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102493|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102494|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102495|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102496|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102497|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102498|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102499|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102500|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102501|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102502|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102503|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102504|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102505|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102506|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102507|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102508|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102509|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102510|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102511|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102512|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102513|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102514|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102515|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102516|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102517|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102518|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102519|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102520|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102521|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102522|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102523|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102524|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102525|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102526|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102527|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102528|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102529|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102530|NCT01585558|E3|Reported Event|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
102531|NCT01585558|E2|Reported Event|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
102532|NCT01585558|E1|Reported Event|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
102533|NCT01585441|B3|Baseline|Total|Total of all reporting groups
102534|NCT01585441|B2|Baseline|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102535|NCT01585441|B1|Baseline|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102536|NCT01585441|P2|Participant Flow|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102537|NCT01585441|P1|Participant Flow|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102538|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102562|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102539|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102540|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102541|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102542|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102543|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102544|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102545|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102546|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102547|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102548|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102549|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102550|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102551|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102552|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102553|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102554|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102555|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102556|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102557|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102558|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102559|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102560|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102561|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102563|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102564|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102565|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102566|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102567|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102568|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102569|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102570|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102571|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102572|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102573|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102574|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102575|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102576|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102577|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102578|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102579|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102580|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102581|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102582|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102583|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102584|NCT01585441|E2|Reported Event|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
102585|NCT01585441|E1|Reported Event|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
102586|NCT01585324|B1|Baseline|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
102587|NCT01585324|P1|Participant Flow|Peginterferon Alpha-2a + Ribavirin|Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (<) 75 kilogram [kg]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
102588|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102589|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102590|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102591|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102592|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102593|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102594|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102595|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102596|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102597|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102813|NCT01584518|E1|Reported Event|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
102814|NCT01584479|B5|Baseline|Total|Total of all reporting groups
102598|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102599|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
102600|NCT01585324|O1|Outcome|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
102601|NCT01585324|E1|Reported Event|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
102602|NCT01585272|B1|Baseline|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102603|NCT01585272|P1|Participant Flow|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102604|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102605|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102606|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102607|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102608|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102609|NCT01585272|E1|Reported Event|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
102610|NCT01585038|B3|Baseline|Total|Total of all reporting groups
102611|NCT01585038|B2|Baseline|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102612|NCT01585038|B1|Baseline|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102613|NCT01585038|P2|Participant Flow|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102614|NCT01585038|P1|Participant Flow|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102615|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102616|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102617|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102618|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102619|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102620|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102621|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102622|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102623|NCT01585038|E2|Reported Event|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
102624|NCT01585038|E1|Reported Event|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
102625|NCT01584843|B5|Baseline|Total|Total of all reporting groups
102768|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102800|NCT01584544|E5|Reported Event|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102626|NCT01584843|B4|Baseline|GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102627|NCT01584843|B3|Baseline|GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102628|NCT01584843|B2|Baseline|GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102629|NCT01584843|B1|Baseline|Non-treatment, Then GSK1358820|Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102630|NCT01584843|P6|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102631|NCT01584843|P5|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102632|NCT01584843|P4|Participant Flow|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102633|NCT01584843|P3|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102769|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102801|NCT01584544|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102634|NCT01584843|P2|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102635|NCT01584843|P1|Participant Flow|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102636|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102637|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102638|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102639|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102640|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102641|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102770|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102802|NCT01584544|E3|Reported Event|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102642|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102643|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102644|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102645|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102646|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102647|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102648|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102649|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102771|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102803|NCT01584544|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102650|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102651|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102652|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102653|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102654|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102655|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102656|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102657|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102674|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102658|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102659|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102660|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102661|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102662|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102663|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102664|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102665|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102755|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102804|NCT01584544|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102666|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102667|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102668|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102669|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102670|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102671|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102672|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102673|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102756|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102757|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102675|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102676|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102677|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102678|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102679|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102680|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102681|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102682|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102758|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102772|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102683|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102684|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102685|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102686|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102687|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102688|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102689|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102690|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102759|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102796|NCT01584544|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102691|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102692|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102693|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102694|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102695|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102696|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102697|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102698|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102760|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102761|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102699|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102700|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102701|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102702|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102703|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102704|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102705|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102706|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102762|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102797|NCT01584544|O3|Outcome|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102805|NCT01584518|B3|Baseline|Total|Total of all reporting groups
102707|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102708|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102709|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102710|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102711|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102712|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102713|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102714|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102763|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102798|NCT01584544|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102715|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102716|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102717|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102718|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102719|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102720|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102721|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102722|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102764|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102765|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102723|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102724|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102725|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102726|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102727|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102728|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102729|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102730|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102766|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102799|NCT01584544|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102731|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102732|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102733|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102734|NCT01584843|O4|Outcome|SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102735|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102736|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102737|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102738|NCT01584843|E5|Reported Event|GSK1358820 5.0 U|Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102767|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102806|NCT01584518|B2|Baseline|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
102807|NCT01584518|B1|Baseline|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
102739|NCT01584843|E4|Reported Event|GSK1358820 2.5 U|Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102740|NCT01584843|E3|Reported Event|GSK1358820 1.25 U|Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
102741|NCT01584843|E2|Reported Event|Non-treatment, Then GSK1358820|Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
102742|NCT01584843|E1|Reported Event|Non-treatment|Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.
102743|NCT01584648|B3|Baseline|Total|Total of all reporting groups
102744|NCT01584648|B2|Baseline|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102745|NCT01584648|B1|Baseline|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102746|NCT01584648|P2|Participant Flow|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102747|NCT01584648|P1|Participant Flow|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102748|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102749|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102750|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102751|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102752|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102753|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102754|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102808|NCT01584518|P2|Participant Flow|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
102773|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102774|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102775|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102776|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102777|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102778|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102779|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102780|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102781|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102782|NCT01584648|E2|Reported Event|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102783|NCT01584648|E1|Reported Event|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
102784|NCT01584544|B6|Baseline|Total|Total of all reporting groups
102785|NCT01584544|B5|Baseline|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102786|NCT01584544|B4|Baseline|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102787|NCT01584544|B3|Baseline|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102788|NCT01584544|B2|Baseline|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102789|NCT01584544|B1|Baseline|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102790|NCT01584544|P5|Participant Flow|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102791|NCT01584544|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102792|NCT01584544|P3|Participant Flow|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102793|NCT01584544|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102794|NCT01584544|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102795|NCT01584544|O5|Outcome|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
102809|NCT01584518|P1|Participant Flow|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
102815|NCT01584479|B4|Baseline|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102816|NCT01584479|B3|Baseline|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102817|NCT01584479|B2|Baseline|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102818|NCT01584479|B1|Baseline|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102819|NCT01584479|P4|Participant Flow|High Risk Control Group|"2 visits - High Risk 1,847 evaluable subjects~High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102820|NCT01584479|P3|Participant Flow|High Risk Experimental Group|"1 visit - High Risk 852 evaluable subjects~High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102821|NCT01584479|P2|Participant Flow|Low Risk Control Group|"2 visits - Low Risk 1,668 evaluable subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102822|NCT01584479|P1|Participant Flow|Low Risk Experimental Group|"1 visit - Low Risk 732 evaluable subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102823|NCT01584479|O4|Outcome|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102824|NCT01584479|O3|Outcome|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102825|NCT01584479|O2|Outcome|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102826|NCT01584479|O1|Outcome|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102827|NCT01584479|E4|Reported Event|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102828|NCT01584479|E3|Reported Event|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
102829|NCT01584479|E2|Reported Event|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102830|NCT01584479|E1|Reported Event|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
102831|NCT01584232|B3|Baseline|Total|Total of all reporting groups
102832|NCT01584232|B2|Baseline|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102833|NCT01584232|B1|Baseline|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102834|NCT01584232|P2|Participant Flow|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102835|NCT01584232|P1|Participant Flow|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102836|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102837|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102838|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102864|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102839|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102840|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102841|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102842|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102843|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102844|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102845|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102846|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102847|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102848|NCT01584232|E2|Reported Event|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102849|NCT01584232|E1|Reported Event|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
102850|NCT01583894|B1|Baseline|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
102851|NCT01583894|P1|Participant Flow|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
102852|NCT01583894|O1|Outcome|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
102853|NCT01583894|E1|Reported Event|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
102854|NCT01583647|B1|Baseline|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102855|NCT01583647|P2|Participant Flow|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102856|NCT01583647|P1|Participant Flow|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102857|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102858|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102859|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102860|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102861|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102862|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102863|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
103459|NCT01580098|O1|Outcome|Control Group|treatment as usual
102865|NCT01583647|E2|Reported Event|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102866|NCT01583647|E1|Reported Event|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
102867|NCT01583530|B7|Baseline|Total|Total of all reporting groups
102868|NCT01583530|B6|Baseline|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102869|NCT01583530|B5|Baseline|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102870|NCT01583530|B4|Baseline|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102871|NCT01583530|B3|Baseline|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102872|NCT01583530|B2|Baseline|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102873|NCT01583530|B1|Baseline|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102874|NCT01583530|P6|Participant Flow|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102875|NCT01583530|P5|Participant Flow|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102876|NCT01583530|P4|Participant Flow|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102877|NCT01583530|P3|Participant Flow|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102878|NCT01583530|P2|Participant Flow|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102879|NCT01583530|P1|Participant Flow|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102880|NCT01583530|O6|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102881|NCT01583530|O5|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102882|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102883|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102884|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102885|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102886|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102887|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102888|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102889|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102890|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102891|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102892|NCT01583530|O2|Outcome|Belimumab SC x 1 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102893|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102894|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102895|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102896|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102897|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102898|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102899|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102900|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102901|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102902|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102903|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102904|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102905|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102906|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102907|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102908|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102909|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102910|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102911|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102912|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102913|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102914|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102915|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102916|NCT01583530|E6|Reported Event|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
102917|NCT01583530|E5|Reported Event|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
102918|NCT01583530|E4|Reported Event|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
102919|NCT01583530|E3|Reported Event|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
102920|NCT01583530|E2|Reported Event|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
102921|NCT01583530|E1|Reported Event|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
102922|NCT01583452|B3|Baseline|Total|Total of all reporting groups
102923|NCT01583452|B2|Baseline|No Intervention|By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102924|NCT01583452|B1|Baseline|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102925|NCT01583452|P2|Participant Flow|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102926|NCT01583452|P1|Participant Flow|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102927|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102928|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102929|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102930|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102931|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102932|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102933|NCT01583452|O2|Outcome|Control Group|The time between the end of surgery and the discharge of the patient measured in hours.
102934|NCT01583452|O1|Outcome|Chewing Gum Group|The time between the end of the surgery and the discharge of the patients, measured in hours.
102935|NCT01583452|E2|Reported Event|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
102936|NCT01583452|E1|Reported Event|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
102937|NCT01583374|B4|Baseline|Total|Total of all reporting groups
102938|NCT01583374|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102939|NCT01583374|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102940|NCT01583374|B1|Baseline|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
102941|NCT01583374|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102942|NCT01583374|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102943|NCT01583374|P1|Participant Flow|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
102944|NCT01583374|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase..
102945|NCT01583374|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102946|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
102947|NCT01583374|O2|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
102948|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
102949|NCT01583374|E3|Reported Event|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
102950|NCT01583374|E2|Reported Event|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
102951|NCT01583374|E1|Reported Event|Placebo|Participants initially randomized to receive placebo tablets twice daily.
102952|NCT01582854|B3|Baseline|Total|Total of all reporting groups
102953|NCT01582854|B2|Baseline|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102954|NCT01582854|B1|Baseline|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102955|NCT01582854|P2|Participant Flow|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102956|NCT01582854|P1|Participant Flow|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102957|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102958|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102959|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102960|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102961|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102962|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102963|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102964|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102965|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102966|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102967|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102968|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102969|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102970|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102971|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102972|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102973|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102974|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102975|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102976|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102977|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102978|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102979|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102980|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102981|NCT01582854|E2|Reported Event|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
102982|NCT01582854|E1|Reported Event|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
102983|NCT01582789|B1|Baseline|Overall Study Group Prior to Dispense|All subjects prior to dispense of first set of study lenses
102984|NCT01582789|P2|Participant Flow|Senofilcon A, Then Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
102985|NCT01582789|P1|Participant Flow|Enfilcon A, Then Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
102986|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
102987|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
102988|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
102989|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
102990|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
102991|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
102992|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
102993|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
102994|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
102995|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
102996|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
102997|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
102998|NCT01582789|E2|Reported Event|Senofilcon A/Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
102999|NCT01582789|E1|Reported Event|Enfilcon A/Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
103000|NCT01582490|B3|Baseline|Total|Total of all reporting groups
103001|NCT01582490|B2|Baseline|Instillation - EXPAREL|"Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.~Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
103002|NCT01582490|B1|Baseline|Infiltration - EXPAREL|"Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.~Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
103003|NCT01582490|P2|Participant Flow|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
103004|NCT01582490|P1|Participant Flow|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
103005|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103006|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103007|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103008|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103009|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103010|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103011|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103012|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103013|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103014|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103015|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103016|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103017|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
103018|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
103019|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
103020|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
103021|NCT01582490|E2|Reported Event|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
103022|NCT01582490|E1|Reported Event|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
103023|NCT01582477|B3|Baseline|Total|Total of all reporting groups
103024|NCT01582477|B2|Baseline|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103025|NCT01582477|B1|Baseline|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103026|NCT01582477|P2|Participant Flow|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103027|NCT01582477|P1|Participant Flow|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103028|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103029|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103030|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103031|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103032|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103033|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103034|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103035|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103036|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103037|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103038|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103039|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103040|NCT01582477|E2|Reported Event|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
103041|NCT01582477|E1|Reported Event|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
103042|NCT01582308|B1|Baseline|All Enrolled Participants|
103043|NCT01582308|P10|Participant Flow|Treatment Sequence 10|Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5
103044|NCT01582308|P9|Participant Flow|Treatment Sequence 9|Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
103045|NCT01582308|P8|Participant Flow|Treatment Sequence 8|Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
103046|NCT01582308|P7|Participant Flow|Treatment Sequence 7|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
103047|NCT01582308|P6|Participant Flow|Treatment Sequence 6|Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
103048|NCT01582308|P5|Participant Flow|Treatment Sequence 5|Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
103049|NCT01582308|P4|Participant Flow|Treatment Sequence 4|Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
103050|NCT01582308|P3|Participant Flow|Treatment Sequence 3|Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
103051|NCT01582308|P2|Participant Flow|Treatment Sequence 2|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
103052|NCT01582308|P1|Participant Flow|Treatment Sequence 1|Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
103053|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103054|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
103055|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
103056|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
103057|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103058|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
103059|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
103060|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
103061|NCT01582308|O1|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103062|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103063|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
103064|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
103065|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
103066|NCT01582308|O5|Outcome|Placebo|Placebo to sitagliptin daily for 5 days
103067|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103068|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
103069|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
103070|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
103071|NCT01582308|E5|Reported Event|Placebo|Placebo to sitagliptin daily for 5 days
103072|NCT01582308|E4|Reported Event|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
103073|NCT01582308|E3|Reported Event|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
103074|NCT01582308|E2|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
103075|NCT01582308|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
103076|NCT01582282|B4|Baseline|Total|Total of all reporting groups
103077|NCT01582282|B3|Baseline|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103078|NCT01582282|B2|Baseline|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103079|NCT01582282|B1|Baseline|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103080|NCT01582282|P3|Participant Flow|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103081|NCT01582282|P2|Participant Flow|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103082|NCT01582282|P1|Participant Flow|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103083|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103084|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103085|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103086|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103087|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103088|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103089|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103090|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103091|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103092|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103093|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103094|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103095|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103096|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103097|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103098|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103099|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103100|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103101|NCT01582282|E3|Reported Event|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
103102|NCT01582282|E2|Reported Event|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
103103|NCT01582282|E1|Reported Event|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
103104|NCT01582243|B1|Baseline|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103105|NCT01582243|P1|Participant Flow|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103106|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103107|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103108|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103109|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103110|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103111|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103112|NCT01582243|E1|Reported Event|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
103113|NCT01582178|B3|Baseline|Total|Total of all reporting groups
103114|NCT01582178|B2|Baseline|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103115|NCT01582178|B1|Baseline|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103116|NCT01582178|P2|Participant Flow|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103117|NCT01582178|P1|Participant Flow|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103118|NCT01582178|O2|Outcome|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103119|NCT01582178|O1|Outcome|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103120|NCT01582178|E2|Reported Event|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103121|NCT01582178|E1|Reported Event|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
103122|NCT01582139|B3|Baseline|Total|Total of all reporting groups
103123|NCT01582139|B2|Baseline|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
103124|NCT01582139|B1|Baseline|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
103125|NCT01582139|P2|Participant Flow|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
103126|NCT01582139|P1|Participant Flow|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
103127|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
103128|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
103129|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
103130|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
103131|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
103132|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
103133|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
103134|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
103135|NCT01582139|E2|Reported Event|Experimental: Heart Rate Informed SSM+HMM|"Experimental:~An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
103136|NCT01582139|E1|Reported Event|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
103137|NCT01582100|B1|Baseline|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
103138|NCT01582100|P1|Participant Flow|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
103139|NCT01582100|O1|Outcome|Single Arm Subjects With GERD/Nausea|This is a single arm study measuring the incidence and severity of nausea with or without vomiting in patients with GERD before and after treatment with Reletex
103140|NCT01582100|E1|Reported Event|Wrist Discomfort|subject did not like the feel of the device on wrist
103141|NCT01581931|B1|Baseline|Overall Study|This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days.
103142|NCT01581931|P2|Participant Flow|Lina+Met FDC Tablet / Lina+Met Single Tablets|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2.
103143|NCT01581931|P1|Participant Flow|Lina+Met Single Tablets / Lina+Met FDC Tablet|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2.
103144|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103145|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103146|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103147|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103148|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103149|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103150|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103151|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103152|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103153|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103154|NCT01581931|E2|Reported Event|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
103155|NCT01581931|E1|Reported Event|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
103156|NCT01581684|B11|Baseline|Total|Total of all reporting groups
103157|NCT01581684|B10|Baseline|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
103158|NCT01581684|B9|Baseline|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
103159|NCT01581684|B8|Baseline|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103160|NCT01581684|B7|Baseline|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103161|NCT01581684|B6|Baseline|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103162|NCT01581684|B5|Baseline|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103163|NCT01581684|B4|Baseline|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103164|NCT01581684|B3|Baseline|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103165|NCT01581684|B2|Baseline|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103166|NCT01581684|B1|Baseline|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
103167|NCT01581684|P10|Participant Flow|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
103168|NCT01581684|P9|Participant Flow|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
103169|NCT01581684|P8|Participant Flow|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103170|NCT01581684|P7|Participant Flow|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103171|NCT01581684|P6|Participant Flow|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103172|NCT01581684|P5|Participant Flow|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103173|NCT01581684|P4|Participant Flow|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103174|NCT01581684|P3|Participant Flow|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103175|NCT01581684|P2|Participant Flow|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103176|NCT01581684|P1|Participant Flow|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
103177|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103178|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103179|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
103180|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103181|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103182|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103183|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103184|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103185|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103186|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103187|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
103188|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103189|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103190|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
103191|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103192|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103193|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103194|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103195|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103196|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103197|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103198|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
103199|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103200|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103201|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103202|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103203|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103204|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103205|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103206|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103207|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103208|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103209|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103210|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103211|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103212|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103213|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103214|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103215|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103216|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103217|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103218|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103219|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103220|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103221|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103222|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103223|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103224|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103225|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103226|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103227|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103228|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103229|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103230|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103231|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103232|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103233|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103234|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103235|NCT01581684|E11|Reported Event|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
103236|NCT01581684|E10|Reported Event|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
103237|NCT01581684|E9|Reported Event|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
103238|NCT01581684|E8|Reported Event|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
103239|NCT01581684|E7|Reported Event|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
103240|NCT01581684|E6|Reported Event|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
103241|NCT01581684|E5|Reported Event|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
103242|NCT01581684|E4|Reported Event|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
103243|NCT01581684|E3|Reported Event|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
103244|NCT01581684|E2|Reported Event|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
103245|NCT01581684|E1|Reported Event|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
103246|NCT01581658|B5|Baseline|Total|Total of all reporting groups
103247|NCT01581658|B4|Baseline|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103248|NCT01581658|B3|Baseline|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103249|NCT01581658|B2|Baseline|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103250|NCT01581658|B1|Baseline|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103251|NCT01581658|P4|Participant Flow|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103252|NCT01581658|P3|Participant Flow|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103253|NCT01581658|P2|Participant Flow|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103254|NCT01581658|P1|Participant Flow|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103255|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103256|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103257|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103258|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103259|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103260|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103261|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103262|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103263|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103264|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103265|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103266|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103267|NCT01581658|E4|Reported Event|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
103268|NCT01581658|E3|Reported Event|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
103269|NCT01581658|E2|Reported Event|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
103270|NCT01581658|E1|Reported Event|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
103271|NCT01581437|B1|Baseline|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103272|NCT01581437|P1|Participant Flow|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103273|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
103274|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
103275|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: Outcome:78 patients enrolled multicenter"
103276|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103277|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103278|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter"
103279|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter."
103280|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103281|NCT01581437|E1|Reported Event|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
103282|NCT01581307|B1|Baseline|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
103283|NCT01581307|P1|Participant Flow|2nd Line Chemotherapy With Radiotherapy|"Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy is given every two weeks for 6‐10 cycles.~The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.~FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.~TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated"
103284|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
103285|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
103286|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
103287|NCT01581307|E1|Reported Event|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
103288|NCT01581021|B3|Baseline|Total|Total of all reporting groups
103289|NCT01581021|B2|Baseline|Laminar Hooks|Group treated with hooks in the thoracic spine
103290|NCT01581021|B1|Baseline|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103291|NCT01581021|P2|Participant Flow|Laminar Hooks|Group treated with hooks in the thoracic spine
103292|NCT01581021|P1|Participant Flow|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103293|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
103294|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103295|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
103296|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103297|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
103298|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103299|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
103300|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103301|NCT01581021|E2|Reported Event|Laminar Hooks|Group treated with hooks in the thoracic spine
103302|NCT01581021|E1|Reported Event|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
103303|NCT01581008|B3|Baseline|Total|Total of all reporting groups
103304|NCT01581008|B2|Baseline|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
103305|NCT01581008|B1|Baseline|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103306|NCT01581008|P2|Participant Flow|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
103307|NCT01581008|P1|Participant Flow|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103308|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103309|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
103310|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103311|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
103312|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103313|NCT01581008|E2|Reported Event|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
103314|NCT01581008|E1|Reported Event|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
103315|NCT01580995|B3|Baseline|Total|Total of all reporting groups
103316|NCT01580995|B2|Baseline|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
103317|NCT01580995|B1|Baseline|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
103318|NCT01580995|P2|Participant Flow|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
103319|NCT01580995|P1|Participant Flow|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
103320|NCT01580995|O2|Outcome|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
103321|NCT01580995|O1|Outcome|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
103322|NCT01580995|E2|Reported Event|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
103323|NCT01580995|E1|Reported Event|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
103324|NCT01580904|B3|Baseline|Total|Total of all reporting groups
103325|NCT01580904|B2|Baseline|Control Group|Patients will not be followed by the pharmacist.
103326|NCT01580904|B1|Baseline|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103327|NCT01580904|P2|Participant Flow|Control Group|Patients will not be followed by the pharmacist.
103328|NCT01580904|P1|Participant Flow|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103329|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103330|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
103331|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103332|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
103333|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103334|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
103335|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103336|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
103337|NCT01580904|E2|Reported Event|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
103338|NCT01580904|E1|Reported Event|Control Group|Patients will not be followed by the pharmacist.
103339|NCT01580618|B3|Baseline|Total|Total of all reporting groups
103340|NCT01580618|B2|Baseline|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103341|NCT01580618|B1|Baseline|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103342|NCT01580618|P2|Participant Flow|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103343|NCT01580618|P1|Participant Flow|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103344|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103345|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103346|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103347|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103348|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103349|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103350|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103351|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103352|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103353|NCT01580618|E2|Reported Event|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
103354|NCT01580618|E1|Reported Event|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
103355|NCT01580592|B4|Baseline|Total|Total of all reporting groups
103356|NCT01580592|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
103357|NCT01580592|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
103358|NCT01580592|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
103359|NCT01580592|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
103360|NCT01580592|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
103361|NCT01580592|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
103362|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
103363|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
103364|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
103365|NCT01580592|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
103366|NCT01580592|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
103367|NCT01580592|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
103368|NCT01580488|B1|Baseline|All Study Participants|
103369|NCT01580488|P1|Participant Flow|All Study Participants|"Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation B containing 20 mg/g LEO 35299 Topical cream formulation C containing 20 mg/g LEO 35299 Topical solution formulation E containing 10 mg/g LEO 35299 Topical solution formulation F containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle"
103370|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103371|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103372|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103373|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103374|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103375|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103376|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103377|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103378|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103379|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103380|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103381|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103382|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103383|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103384|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103385|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103386|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103387|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103388|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103389|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103390|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103391|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103392|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103393|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103394|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103395|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103396|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103397|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103398|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103399|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103400|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
103401|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103402|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103403|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103404|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103405|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103406|NCT01580488|E6|Reported Event|Daivonex® Ointment|Topical ointment vehicle
103407|NCT01580488|E5|Reported Event|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
103408|NCT01580488|E4|Reported Event|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
103409|NCT01580488|E3|Reported Event|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
103410|NCT01580488|E2|Reported Event|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
103411|NCT01580488|E1|Reported Event|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
103412|NCT01580423|B1|Baseline|Entire Study Population|Includes groups randomized to receive aprepitant first and inert powder first.
103413|NCT01580423|P2|Participant Flow|First Inert Powder, Then Aprepitant|Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
103414|NCT01580423|P1|Participant Flow|First Aprepitant, Then Inert Powder|Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
103415|NCT01580423|O2|Outcome|Inert Powder|Capsule containing insert powder
103416|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
103417|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
103418|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
103419|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
103420|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
103421|NCT01580423|E2|Reported Event|Inert Powder|Capsule filled with inert powder
103422|NCT01580423|E1|Reported Event|Aprepitant|Capsule filled with 125 mg of aprepitant
103423|NCT01580306|B5|Baseline|Total|Total of all reporting groups
103424|NCT01580306|B4|Baseline|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103425|NCT01580306|B3|Baseline|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103426|NCT01580306|B2|Baseline|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103427|NCT01580306|B1|Baseline|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103428|NCT01580306|P4|Participant Flow|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103429|NCT01580306|P3|Participant Flow|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103430|NCT01580306|P2|Participant Flow|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103431|NCT01580306|P1|Participant Flow|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103432|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103433|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103434|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103435|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103436|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103437|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103438|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103439|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103440|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103441|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103442|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103443|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103444|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103445|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103446|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103447|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103448|NCT01580306|E4|Reported Event|BI 201335 Relevant Treatment Dose (Severe Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 15-29 mL/min/1.73m2"
103449|NCT01580306|E3|Reported Event|BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 30-59 mL/min/1.73m2"
103450|NCT01580306|E2|Reported Event|BI 201335 Relevant Treatment Dose (Mild Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 60-89 mL/min/1.73m2"
103451|NCT01580306|E1|Reported Event|BI 201335 Relevant Treatment Dose (Normal Renal Function)|"Capsule for oral administration~estimated glomerular filtration rate >= 90 mL/min/1.73m2"
103452|NCT01580098|B3|Baseline|Total|Total of all reporting groups
103453|NCT01580098|B2|Baseline|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103454|NCT01580098|B1|Baseline|Control Group|treatment as usual
103455|NCT01580098|P3|Participant Flow|Nurse-monitoring for Patients With Diabetes Mellitus Type 2|"nurse-monitoring for patients with Diabetes Mellitus~Nurses are entering vital parameters of the patient with mobile devices"
103456|NCT01580098|P2|Participant Flow|Self-monitoring for Patients With Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."
103457|NCT01580098|P1|Participant Flow|Control Group|treatment as usual
103458|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103460|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103461|NCT01580098|O1|Outcome|Control Group|treatment as usual
103462|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103463|NCT01580098|O1|Outcome|Control Group|treatment as usual
103464|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103465|NCT01580098|O1|Outcome|Control Group|treatment as usual
103466|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103467|NCT01580098|O1|Outcome|Control Group|treatment as usual
103468|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103469|NCT01580098|O1|Outcome|Control Group|treatment as usual
103470|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103471|NCT01580098|O1|Outcome|Control Group|treatment as usual
103472|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103473|NCT01580098|O1|Outcome|Control Group|treatment as usual
103474|NCT01580098|E2|Reported Event|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
103475|NCT01580098|E1|Reported Event|Control Group|treatment as usual
103476|NCT01580072|B4|Baseline|Total|Total of all reporting groups
103477|NCT01580072|B3|Baseline|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103478|NCT01580072|B2|Baseline|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103479|NCT01580072|B1|Baseline|Control Group|Participants in the control group receive usual care.
103480|NCT01580072|P3|Participant Flow|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103481|NCT01580072|P2|Participant Flow|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103482|NCT01580072|P1|Participant Flow|Control Group|Participants in the control group receive usual care.
103483|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103484|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103485|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103486|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103487|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103488|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103489|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103490|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103491|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103492|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103493|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103494|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103495|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103496|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103497|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103498|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103499|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103500|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103501|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103502|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103503|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
103504|NCT01580072|E3|Reported Event|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
103505|NCT01580072|E2|Reported Event|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
103506|NCT01580072|E1|Reported Event|Control Group|Participants in the control group receive usual care.
103507|NCT01580020|B3|Baseline|Total|Total of all reporting groups
103508|NCT01580020|B2|Baseline|Dexamethasone|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103509|NCT01580020|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103510|NCT01580020|P4|Participant Flow|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103511|NCT01580020|P3|Participant Flow|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
103512|NCT01580020|P2|Participant Flow|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103513|NCT01580020|P1|Participant Flow|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103514|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103515|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103516|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103517|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103518|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103519|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103520|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103521|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103522|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103523|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103524|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103525|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103526|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103527|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103528|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103529|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103530|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103531|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103532|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103533|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103534|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103535|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103536|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103537|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103538|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103539|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103540|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103541|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103542|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103543|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103544|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103545|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103546|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103547|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103864|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103548|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
103549|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103550|NCT01580020|E4|Reported Event|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103551|NCT01580020|E3|Reported Event|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103552|NCT01580020|E2|Reported Event|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
103553|NCT01580020|E1|Reported Event|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
103554|NCT01579916|B3|Baseline|TOTAL|Total of all reporting groups
103555|NCT01579916|B2|Baseline|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103556|NCT01579916|B1|Baseline|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103557|NCT01579916|P2|Participant Flow|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103558|NCT01579916|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103559|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103560|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103561|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103562|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103563|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103564|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103565|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103566|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103567|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103568|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103569|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103570|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103571|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103915|NCT01578785|P1|Participant Flow|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103572|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103573|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103574|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103575|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103576|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103577|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103578|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103579|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103580|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103581|NCT01579916|E2|Reported Event|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
103582|NCT01579916|E1|Reported Event|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
103583|NCT01579747|B3|Baseline|Total|Total of all reporting groups
103584|NCT01579747|B2|Baseline|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
103585|NCT01579747|B1|Baseline|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
103586|NCT01579747|P2|Participant Flow|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
103587|NCT01579747|P1|Participant Flow|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
103588|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
103589|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
103590|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
103591|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
103592|NCT01579747|E2|Reported Event|Ultrasound Guided Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
103593|NCT01579747|E1|Reported Event|Nerve Stimulation Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
103594|NCT01579669|B3|Baseline|Total|Total of all reporting groups
103595|NCT01579669|B2|Baseline|Primary Care Providers|Primary care providers taking care of autistic adults participating in this study
103596|NCT01579669|B1|Baseline|Autistic Adults|Adults on the autism spectrum
103597|NCT01579669|P2|Participant Flow|Primary Care Providers|Participants' primary care providers
103598|NCT01579669|P1|Participant Flow|Autistic Adults|Adults on the autism spectrum
103599|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
103600|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
103601|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
103602|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
103603|NCT01579669|O1|Outcome|Primary Care Providers|Participants' primary care providers
103604|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
103605|NCT01579669|E2|Reported Event|Primary Care Providers|Primary care providers of autistic adults participating in the study.
103606|NCT01579669|E1|Reported Event|Autistic Adults|Adults on the autism spectrum
103607|NCT01579578|B3|Baseline|Total|Total of all reporting groups
103608|NCT01579578|B2|Baseline|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103609|NCT01579578|B1|Baseline|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103610|NCT01579578|P2|Participant Flow|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103611|NCT01579578|P1|Participant Flow|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103612|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103613|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103614|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103615|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103616|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103617|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103618|NCT01579578|E2|Reported Event|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103619|NCT01579578|E1|Reported Event|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
103620|NCT01579565|B3|Baseline|Total|Total of all reporting groups
103621|NCT01579565|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103622|NCT01579565|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103623|NCT01579565|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103624|NCT01579565|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103625|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103626|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103627|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103654|NCT01579474|B4|Baseline|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
104236|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
103628|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103629|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103630|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103631|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103632|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103633|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103634|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103635|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103636|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103637|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103638|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103639|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103640|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103641|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103642|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103643|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103644|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103645|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103646|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103647|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103648|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103649|NCT01579565|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103650|NCT01579565|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
103651|NCT01579474|B7|Baseline|Total|Total of all reporting groups
103652|NCT01579474|B6|Baseline|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103653|NCT01579474|B5|Baseline|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103655|NCT01579474|B3|Baseline|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103656|NCT01579474|B2|Baseline|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103657|NCT01579474|B1|Baseline|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103658|NCT01579474|P6|Participant Flow|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103659|NCT01579474|P5|Participant Flow|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103660|NCT01579474|P4|Participant Flow|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103661|NCT01579474|P3|Participant Flow|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103662|NCT01579474|P2|Participant Flow|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103663|NCT01579474|P1|Participant Flow|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
103664|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103665|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103666|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103667|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103668|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103669|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103670|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103671|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103672|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103673|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103674|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103675|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103676|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103677|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103678|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103679|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103680|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103681|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103682|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103683|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103684|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103685|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103686|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103687|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103688|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103689|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103690|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103691|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103692|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103693|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103694|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103695|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103696|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103697|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103698|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103699|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103700|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103701|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103702|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103703|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103704|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103705|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103706|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103707|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103708|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103709|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103710|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103711|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103712|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103859|NCT01578850|B1|Baseline|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103713|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103714|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103715|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103716|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103717|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103718|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103719|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103720|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103721|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103722|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103723|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103724|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
103725|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
103726|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
103727|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
103728|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103729|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103730|NCT01579474|O3|Outcome|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
103731|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103732|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
103733|NCT01579474|E3|Reported Event|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
103734|NCT01579474|E2|Reported Event|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
103735|NCT01579474|E1|Reported Event|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
103736|NCT01579305|B3|Baseline|Total|Total of all reporting groups
103737|NCT01579305|B2|Baseline|Subjects Randomized to Receive Restylane-L®|
103738|NCT01579305|B1|Baseline|Subjects Randomized to Receive VOLBELLA®|
103739|NCT01579305|P2|Participant Flow|Subjects Randomized to Receive Restylane-L®|
103740|NCT01579305|P1|Participant Flow|Subject Randomized to Receive VOLBELLA®|
103741|NCT01579305|O2|Outcome|Subjects Randomized to Receive Restylane-L® and Treated|
103742|NCT01579305|O1|Outcome|Subjects Randomized to Receive VOLBELLA® and Treated|
103743|NCT01579305|E2|Reported Event|Subjects Treated With Restylane-L®|
103744|NCT01579305|E1|Reported Event|Subjects Treated With VOLBELLA®|
103745|NCT01579084|B11|Baseline|Total|Total of all reporting groups
103746|NCT01579084|B10|Baseline|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
103747|NCT01579084|B9|Baseline|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
103748|NCT01579084|B8|Baseline|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
103749|NCT01579084|B7|Baseline|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
103750|NCT01579084|B6|Baseline|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103751|NCT01579084|B5|Baseline|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103752|NCT01579084|B4|Baseline|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103753|NCT01579084|B3|Baseline|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
103754|NCT01579084|B2|Baseline|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
103755|NCT01579084|B1|Baseline|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
103756|NCT01579084|P10|Participant Flow|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
103757|NCT01579084|P9|Participant Flow|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
103758|NCT01579084|P8|Participant Flow|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
103759|NCT01579084|P7|Participant Flow|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
103760|NCT01579084|P6|Participant Flow|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103761|NCT01579084|P5|Participant Flow|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103762|NCT01579084|P4|Participant Flow|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103763|NCT01579084|P3|Participant Flow|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
103764|NCT01579084|P2|Participant Flow|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
103765|NCT01579084|P1|Participant Flow|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
103766|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
103767|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
103768|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
103769|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
103770|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
103771|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
103772|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
103773|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
103774|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
103775|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
103776|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
103777|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
103778|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
103779|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
103780|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
103781|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
103782|NCT01579084|E10|Reported Event|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
103783|NCT01579084|E9|Reported Event|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
103784|NCT01579084|E8|Reported Event|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
103785|NCT01579084|E7|Reported Event|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
103786|NCT01579084|E6|Reported Event|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103787|NCT01579084|E5|Reported Event|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103788|NCT01579084|E4|Reported Event|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
103789|NCT01579084|E3|Reported Event|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
103790|NCT01579084|E2|Reported Event|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
103791|NCT01579084|E1|Reported Event|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
103792|NCT01579045|B1|Baseline|Overall Subjects|All subjects who were enrolled, and completed the study.
103793|NCT01579045|P1|Participant Flow|All Subjects|All subjects who were enrolled.
103794|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103795|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103796|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103797|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103798|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103799|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103800|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103801|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103802|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103803|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103804|NCT01579045|E5|Reported Event|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103805|NCT01579045|E4|Reported Event|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103806|NCT01579045|E3|Reported Event|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103807|NCT01579045|E2|Reported Event|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103860|NCT01578850|P3|Participant Flow|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103861|NCT01578850|P2|Participant Flow|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103808|NCT01579045|E1|Reported Event|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
103809|NCT01579006|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103810|NCT01579006|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103811|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103812|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103813|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103814|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103815|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103816|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103817|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103818|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103819|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103820|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103821|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103822|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103862|NCT01578850|P1|Participant Flow|Open-Label Treatment|Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
103863|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103823|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103824|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103825|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103826|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103827|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103828|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103829|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103830|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103831|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103832|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103833|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103834|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103835|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103836|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103837|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103838|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103839|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103840|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103841|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103842|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103843|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103844|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103845|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103846|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
103847|NCT01579006|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
103848|NCT01578993|B1|Baseline|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
103849|NCT01578993|P1|Participant Flow|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
103850|NCT01578993|O1|Outcome|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
103851|NCT01578993|E1|Reported Event|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
103852|NCT01578980|B1|Baseline|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
103853|NCT01578980|P1|Participant Flow|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
103854|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
103855|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
103856|NCT01578980|E1|Reported Event|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
103857|NCT01578850|B3|Baseline|Total|Total of all reporting groups
103858|NCT01578850|B2|Baseline|Placebo|Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
103865|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103866|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103867|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103868|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103869|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103870|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103871|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103872|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103873|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103874|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103875|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103876|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103877|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103878|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103879|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103880|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103881|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103882|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103883|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103884|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103885|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103886|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103887|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103888|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103889|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103890|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103891|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103892|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103893|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103894|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103895|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103896|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103897|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103898|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103899|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103900|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103901|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103902|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103903|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
103904|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103905|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103906|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103907|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103908|NCT01578850|E3|Reported Event|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
103909|NCT01578850|E2|Reported Event|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
103910|NCT01578850|E1|Reported Event|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).
103911|NCT01578785|B3|Baseline|Total|Total of all reporting groups
103912|NCT01578785|B2|Baseline|GA 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103913|NCT01578785|B1|Baseline|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103914|NCT01578785|P2|Participant Flow|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103916|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103917|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103918|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103919|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103920|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103921|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103922|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103923|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103924|NCT01578785|E2|Reported Event|Ga 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
103925|NCT01578785|E1|Reported Event|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
103926|NCT01578772|B1|Baseline|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
103927|NCT01578772|P1|Participant Flow|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
103928|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
103929|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
103930|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
103931|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
103932|NCT01578772|E1|Reported Event|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
103933|NCT01578707|B3|Baseline|Total|Total of all reporting groups
103934|NCT01578707|B2|Baseline|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
103935|NCT01578707|B1|Baseline|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
103936|NCT01578707|P2|Participant Flow|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
103937|NCT01578707|P1|Participant Flow|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
103938|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
103939|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
103940|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
103941|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
103942|NCT01578707|E2|Reported Event|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
103943|NCT01578707|E1|Reported Event|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
103944|NCT01578330|B1|Baseline|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103945|NCT01578330|P1|Participant Flow|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103946|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103947|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103948|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103949|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103950|NCT01578330|E1|Reported Event|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
103951|NCT01578187|B1|Baseline|Hair2Go Device|The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
104000|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103952|NCT01578187|P1|Participant Flow|Hair2Go Device|"This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment.~The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM) test."
103953|NCT01578187|O2|Outcome|Usability - Non Critical Error|Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
103954|NCT01578187|O1|Outcome|Usability - Critical Error|Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
103955|NCT01578187|O1|Outcome|Label Comprehension Group|Subjects that participated in the label comprehension phase of the study
103956|NCT01578187|E1|Reported Event|Hair2Go (Me) Device|The subjects who participated in the label comprehension phase; the majority of whom participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
103957|NCT01578044|B3|Baseline|Total|Total of all reporting groups
103958|NCT01578044|B2|Baseline|Usual Care Group|"Usual care~Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
103959|NCT01578044|B1|Baseline|Intervention Group|"Patients who are randomized to the intervention group will receive the following:~Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication."
103960|NCT01578044|P2|Participant Flow|Usual Care|"Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
103961|NCT01578044|P1|Participant Flow|Intervention Group|"Intervention patients will receive the following:~Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
103962|NCT01578044|O2|Outcome|Usual Care Group|All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
103963|NCT01578044|O1|Outcome|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
103964|NCT01578044|E2|Reported Event|Usual Care Group|"Usual care~All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study."
103965|NCT01578044|E1|Reported Event|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
103966|NCT01577966|B1|Baseline|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
103967|NCT01577966|P1|Participant Flow|Sulfasalazine|Sulfasalazine
103968|NCT01577966|O1|Outcome|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
104001|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103969|NCT01577966|E1|Reported Event|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
103970|NCT01577758|B1|Baseline|All Participants|All participants who participated in the Dose Escalation and mCRC Expansion Phases.
103971|NCT01577758|P8|Participant Flow|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
103972|NCT01577758|P7|Participant Flow|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103973|NCT01577758|P6|Participant Flow|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103974|NCT01577758|P5|Participant Flow|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103975|NCT01577758|P4|Participant Flow|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103976|NCT01577758|P3|Participant Flow|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103977|NCT01577758|P2|Participant Flow|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103978|NCT01577758|P1|Participant Flow|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103979|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103980|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103981|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103982|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103983|NCT01577758|O8|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
103984|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103985|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103986|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103987|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103988|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103989|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103990|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103991|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
103992|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
103993|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
103994|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
103995|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
103996|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103997|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103998|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
103999|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104002|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104003|NCT01577758|E7|Reported Event|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104004|NCT01577758|E6|Reported Event|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104005|NCT01577758|E5|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104006|NCT01577758|E4|Reported Event|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104007|NCT01577758|E3|Reported Event|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104008|NCT01577758|E2|Reported Event|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104009|NCT01577758|E1|Reported Event|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
104010|NCT01577732|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104011|NCT01577732|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104012|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104013|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104014|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104015|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104016|NCT01577732|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
104017|NCT01577628|B3|Baseline|Total|Total of all reporting groups
104018|NCT01577628|B2|Baseline|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104019|NCT01577628|B1|Baseline|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104020|NCT01577628|P3|Participant Flow|Screen Only|Subject was not randomized to either treatment prior to study termination.
104021|NCT01577628|P2|Participant Flow|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104022|NCT01577628|P1|Participant Flow|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104023|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104024|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104025|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104026|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104027|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104028|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104029|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104030|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104031|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104032|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104033|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104034|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104035|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104036|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104037|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104038|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104039|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104040|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104041|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104042|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104043|NCT01577628|E2|Reported Event|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
104044|NCT01577628|E1|Reported Event|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
104045|NCT01577381|B5|Baseline|Total|Total of all reporting groups
104046|NCT01577381|B4|Baseline|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104047|NCT01577381|B3|Baseline|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104048|NCT01577381|B2|Baseline|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104049|NCT01577381|B1|Baseline|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104050|NCT01577381|P4|Participant Flow|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104051|NCT01577381|P3|Participant Flow|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104052|NCT01577381|P2|Participant Flow|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104053|NCT01577381|P1|Participant Flow|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104054|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104055|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104056|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104057|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104058|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104059|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104060|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104061|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104062|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104063|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104064|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104065|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104066|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104067|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104068|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104069|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104070|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104071|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104072|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104073|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104074|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104075|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104076|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104077|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104078|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104079|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104080|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104081|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104082|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104083|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104084|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104085|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104086|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104087|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104088|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104089|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104090|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104091|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104092|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104093|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104094|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104095|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104096|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104097|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104098|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104099|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104100|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104101|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104102|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104103|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104104|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104105|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104106|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104107|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104108|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104109|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104110|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104111|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104112|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104113|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104114|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104115|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104116|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104117|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104118|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104119|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104120|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104121|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104122|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104123|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104124|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104125|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104126|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104127|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104128|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104129|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104130|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104131|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104132|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104133|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104134|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104135|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104136|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104137|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104138|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104139|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104140|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104141|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104142|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104143|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104144|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104145|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104146|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104147|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104148|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104149|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104150|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104151|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104152|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104153|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104154|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104155|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104156|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104157|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104158|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104159|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104160|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104161|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104234|NCT01576159|O3|Outcome|Non-Impact Loading|Performed non-impact swimming exercise during intervention period.
104162|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104163|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104164|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104165|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104166|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104167|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104168|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104169|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104170|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104171|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104172|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104173|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104174|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104175|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104176|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104177|NCT01577381|E4|Reported Event|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
104178|NCT01577381|E3|Reported Event|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104179|NCT01577381|E2|Reported Event|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
104180|NCT01577381|E1|Reported Event|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
104181|NCT01577186|B1|Baseline|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
104182|NCT01577186|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
104183|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
104184|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
104185|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
104186|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
104187|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
104188|NCT01577186|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
104189|NCT01577160|B1|Baseline|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104190|NCT01577160|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s Clinical Global Impression - Improvement (CGI-I) score.
104191|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104192|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104193|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104194|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104195|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104235|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise during intervention period.
104196|NCT01577160|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
104197|NCT01576952|B3|Baseline|Total|Total of all reporting groups
104198|NCT01576952|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
104199|NCT01576952|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
104200|NCT01576952|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
104201|NCT01576952|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
104202|NCT01576952|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
104203|NCT01576952|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
104204|NCT01576952|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
104205|NCT01576952|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
104206|NCT01576809|B1|Baseline|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104207|NCT01576809|P1|Participant Flow|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104208|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104209|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104210|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104211|NCT01576809|E1|Reported Event|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
104212|NCT01576367|B1|Baseline|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104213|NCT01576367|P1|Participant Flow|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104214|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104215|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104216|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104217|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104218|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104219|NCT01576367|E1|Reported Event|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
104220|NCT01576159|B5|Baseline|Total|Total of all reporting groups
104221|NCT01576159|B4|Baseline|Control Group|Didn't participate any organized physical exercises
104222|NCT01576159|B3|Baseline|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
104223|NCT01576159|B2|Baseline|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
104224|NCT01576159|B1|Baseline|High-Impact Loading|Performed high-impact running exercise during intervention period.
104225|NCT01576159|P4|Participant Flow|Control Group|Didn't participate any organized physical exercises
104226|NCT01576159|P3|Participant Flow|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
104227|NCT01576159|P2|Participant Flow|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
104228|NCT01576159|P1|Participant Flow|High-Impact Loading|Performed high-impact running exercise during intervention period.
104229|NCT01576159|O4|Outcome|Control Group|Not Participated any organized physical exercise
104230|NCT01576159|O3|Outcome|Non-Impact Loading|Performed Non-impact swimming exercise for 12 weeks
104231|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise for 12 weeks
104232|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise for 12 weeks
104233|NCT01576159|O4|Outcome|Control Group|Not participated any organized physical exercise
104237|NCT01576159|O4|Outcome|Control Group|Didn't participate any organized physical exercises
104238|NCT01576159|O3|Outcome|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
104239|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
104240|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
104241|NCT01576159|E4|Reported Event|Control Group|Didn't participate any organized physical exercises
104242|NCT01576159|E3|Reported Event|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
104243|NCT01576159|E2|Reported Event|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
104244|NCT01576159|E1|Reported Event|High-Impact Loading|Performed high-impact running exercise during intervention period.
104245|NCT01576120|B3|Baseline|Total|Total of all reporting groups
104246|NCT01576120|B2|Baseline|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
104247|NCT01576120|B1|Baseline|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
104248|NCT01576120|P2|Participant Flow|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
104249|NCT01576120|P1|Participant Flow|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
104250|NCT01576120|O2|Outcome|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
104251|NCT01576120|O1|Outcome|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
104252|NCT01576120|E2|Reported Event|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
104253|NCT01576120|E1|Reported Event|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
104254|NCT01576055|B3|Baseline|Total|Total of all reporting groups
104255|NCT01576055|B2|Baseline|BARD LifeStent|BARD LifeStent: Implant
104256|NCT01576055|B1|Baseline|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104257|NCT01576055|P2|Participant Flow|BARD LifeStent|BARD LifeStent: Implant
104258|NCT01576055|P1|Participant Flow|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104259|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
104260|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104261|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
104262|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104263|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
104264|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104265|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
104266|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104267|NCT01576055|E2|Reported Event|BARD LifeStent|BARD LifeStent: Implant
104268|NCT01576055|E1|Reported Event|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
104269|NCT01576042|B3|Baseline|Total|Total of all reporting groups
104270|NCT01576042|B2|Baseline|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104271|NCT01576042|B1|Baseline|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104272|NCT01576042|P2|Participant Flow|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104273|NCT01576042|P1|Participant Flow|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104274|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104275|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104276|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104277|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104278|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104279|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104280|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104296|NCT01575899|P3|Participant Flow|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
104297|NCT01575899|P2|Participant Flow|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
104281|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104282|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104283|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104284|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104285|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104286|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104287|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104288|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104289|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104290|NCT01576042|E2|Reported Event|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
104291|NCT01576042|E1|Reported Event|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
104292|NCT01575899|B4|Baseline|Total|Total of all reporting groups
104293|NCT01575899|B3|Baseline|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
104294|NCT01575899|B2|Baseline|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
104295|NCT01575899|B1|Baseline|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
104298|NCT01575899|P1|Participant Flow|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
104299|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
104300|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
104301|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
104302|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
104303|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
104304|NCT01575899|E3|Reported Event|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
104305|NCT01575899|E2|Reported Event|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
104306|NCT01575899|E1|Reported Event|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
104307|NCT01575769|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104308|NCT01575769|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104309|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104310|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104311|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104312|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104313|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104314|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104315|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104316|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104317|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104318|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104319|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104320|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104321|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104322|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104323|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104324|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104325|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104326|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104327|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104328|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104329|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
104330|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
104331|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
104556|NCT01574105|E2|Reported Event|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
104332|NCT01575769|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
104333|NCT01575756|B1|Baseline|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM or Haem|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later or Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
104334|NCT01575756|P2|Participant Flow|Haemocomplettan® P or RiaSTAPTM Followed by Octafibrin|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
104335|NCT01575756|P1|Participant Flow|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later.
104336|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104337|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104338|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104339|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104340|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104341|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104342|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104343|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104344|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104345|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104346|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104347|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104348|NCT01575756|E2|Reported Event|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
104349|NCT01575756|E1|Reported Event|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
104350|NCT01575561|B1|Baseline|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104351|NCT01575561|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104352|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104353|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104354|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104355|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104356|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104357|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104358|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104359|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104360|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104361|NCT01575561|E1|Reported Event|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
104362|NCT01575522|B1|Baseline|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
104363|NCT01575522|P1|Participant Flow|Treatment (Tivantinib)|"Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
104364|NCT01575522|O1|Outcome|Evaluation of c-Met Positive Circulating Tumor Cells|
104365|NCT01575522|O1|Outcome|Evaluation of Phospho c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
104366|NCT01575522|O1|Outcome|Evaluation of c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
104367|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
104417|NCT01575028|O2|Outcome|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
104368|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
104369|NCT01575522|E1|Reported Event|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
104370|NCT01575197|B4|Baseline|Total|Total of all reporting groups
104371|NCT01575197|B3|Baseline|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
104372|NCT01575197|B2|Baseline|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
104373|NCT01575197|B1|Baseline|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104374|NCT01575197|P3|Participant Flow|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age.
104375|NCT01575197|P2|Participant Flow|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age.
104376|NCT01575197|P1|Participant Flow|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age.
104377|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
104378|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104379|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
104380|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104381|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
104382|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104383|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
104384|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104385|NCT01575197|E3|Reported Event|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
104386|NCT01575197|E2|Reported Event|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
104387|NCT01575197|E1|Reported Event|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
104388|NCT01575080|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104389|NCT01575080|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104390|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104391|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104392|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104393|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104394|NCT01575080|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
104395|NCT01575054|B3|Baseline|Total|Total of all reporting groups
104396|NCT01575054|B2|Baseline|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104397|NCT01575054|B1|Baseline|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104398|NCT01575054|P2|Participant Flow|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
105641|NCT01568047|B4|Baseline|BIA 9-1067 (30 mg)|30 mg BIA 9-1067 - OPC, Opicapone
104399|NCT01575054|P1|Participant Flow|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104400|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104401|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104402|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104403|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104404|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104405|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104406|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104407|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104408|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104409|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
104410|NCT01575054|E2|Reported Event|Normal Saline (Placebo)|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
104411|NCT01575054|E1|Reported Event|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
104412|NCT01575028|B3|Baseline|Total|Total of all reporting groups
104413|NCT01575028|B2|Baseline|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
104414|NCT01575028|B1|Baseline|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
104415|NCT01575028|P2|Participant Flow|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
104416|NCT01575028|P1|Participant Flow|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
104557|NCT01574105|E1|Reported Event|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
104558|NCT01574079|B3|Baseline|Total|Total of all reporting groups
104418|NCT01575028|O1|Outcome|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
104419|NCT01575028|E2|Reported Event|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
104420|NCT01575028|E1|Reported Event|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
104421|NCT01574703|B5|Baseline|Total|Total of all reporting groups
104422|NCT01574703|B4|Baseline|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104423|NCT01574703|B3|Baseline|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104424|NCT01574703|B2|Baseline|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104425|NCT01574703|B1|Baseline|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104426|NCT01574703|P4|Participant Flow|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104427|NCT01574703|P3|Participant Flow|Nicotine Replacement Therapy (NRT) Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104428|NCT01574703|P2|Participant Flow|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104429|NCT01574703|P1|Participant Flow|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104430|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104431|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104432|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104433|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104434|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104435|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104436|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104437|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104438|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104439|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104487|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104440|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104441|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104442|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104443|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104444|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104445|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104446|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104447|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104448|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104449|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104450|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104451|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104452|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104453|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104454|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104455|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104456|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104457|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104458|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104459|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104460|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104554|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
104461|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104462|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104463|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104464|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104465|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104466|NCT01574703|E4|Reported Event|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
104467|NCT01574703|E3|Reported Event|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
104468|NCT01574703|E2|Reported Event|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
104469|NCT01574703|E1|Reported Event|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
104470|NCT01574651|B3|Baseline|Total|Total of all reporting groups
104471|NCT01574651|B2|Baseline|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104472|NCT01574651|B1|Baseline|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104473|NCT01574651|P2|Participant Flow|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104474|NCT01574651|P1|Participant Flow|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104475|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104476|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104477|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104478|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104479|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104480|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104481|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104482|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104483|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104484|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104485|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104486|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104555|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
104488|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104489|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104490|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104491|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104492|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104493|NCT01574651|E2|Reported Event|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
104494|NCT01574651|E1|Reported Event|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
104495|NCT01574612|B1|Baseline|Topical Cream|xerese topical cream is the only active used in this trial
104496|NCT01574612|P1|Participant Flow|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
104497|NCT01574612|O1|Outcome|Topical Cream|commercial cream used
104498|NCT01574612|E1|Reported Event|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
104499|NCT01574326|B3|Baseline|Total|Total of all reporting groups
104500|NCT01574326|B2|Baseline|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
104501|NCT01574326|B1|Baseline|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
104502|NCT01574326|P2|Participant Flow|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
104503|NCT01574326|P1|Participant Flow|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
104504|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
104505|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
104506|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
104507|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
104508|NCT01574326|O2|Outcome|FDP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
104509|NCT01574326|O1|Outcome|FDP-Placebo for Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
104510|NCT01574326|E3|Reported Event|DTP - Sevelamer Carbonate|Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
104511|NCT01574326|E2|Reported Event|FDP - Sevelamer Carbonate|Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).
104512|NCT01574326|E1|Reported Event|FDP - Placebo|Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).
104513|NCT01574248|B3|Baseline|Total|Total of all reporting groups
104514|NCT01574248|B2|Baseline|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104515|NCT01574248|B1|Baseline|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104516|NCT01574248|P2|Participant Flow|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104517|NCT01574248|P1|Participant Flow|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104518|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104519|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104520|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104521|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104522|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104523|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104524|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104525|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104526|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104527|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104528|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104529|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104530|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104531|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104532|NCT01574248|E2|Reported Event|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
104533|NCT01574248|E1|Reported Event|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
104534|NCT01574183|B3|Baseline|Total|Total of all reporting groups
104535|NCT01574183|B2|Baseline|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
104536|NCT01574183|B1|Baseline|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
104537|NCT01574183|P2|Participant Flow|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
104538|NCT01574183|P1|Participant Flow|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
104539|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
104540|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
104541|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
104542|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
104543|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: up to 40 mg capsule daily"
104544|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: up to 40 mg capsule daily"
104545|NCT01574183|E2|Reported Event|Placebo|Flexible dose Placebo: up to 40 mg capsule daily
104546|NCT01574183|E1|Reported Event|Vilazodone|Flexible dose Vilazodone: up to 40 mg capsule daily
104547|NCT01574105|B3|Baseline|Total|Total of all reporting groups
104548|NCT01574105|B2|Baseline|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
104549|NCT01574105|B1|Baseline|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
104550|NCT01574105|P2|Participant Flow|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
104551|NCT01574105|P1|Participant Flow|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
104552|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
104553|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
105642|NCT01568047|B3|Baseline|BIA 9-1067 (15 mg)|15 mg BIA 9-1067 - OPC, Opicapone
104559|NCT01574079|B2|Baseline|Physical Therapy Plus Mirror Therapy|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
104560|NCT01574079|B1|Baseline|Traditional Physical Therapy|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104561|NCT01574079|P2|Participant Flow|Physical Therapy Plus Mirror Therapy|The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
104562|NCT01574079|P1|Participant Flow|Traditional Physical Therapy|The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104563|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
104564|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104565|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
104566|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104567|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
104568|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104569|NCT01574079|E2|Reported Event|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
104570|NCT01574079|E1|Reported Event|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
104571|NCT01573910|B3|Baseline|Total|Total of all reporting groups
104572|NCT01573910|B2|Baseline|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104573|NCT01573910|B1|Baseline|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104574|NCT01573910|P2|Participant Flow|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104575|NCT01573910|P1|Participant Flow|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104576|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104577|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104578|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104579|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104580|NCT01573910|E2|Reported Event|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104581|NCT01573910|E1|Reported Event|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
104582|NCT01573767|B5|Baseline|Total|Total of all reporting groups
104583|NCT01573767|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104584|NCT01573767|B3|Baseline|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104585|NCT01573767|B2|Baseline|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104586|NCT01573767|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104587|NCT01573767|P4|Participant Flow|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104588|NCT01573767|P3|Participant Flow|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104589|NCT01573767|P2|Participant Flow|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104590|NCT01573767|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104591|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104592|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104593|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104594|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104595|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104596|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104597|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104598|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104599|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104600|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104601|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104602|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104603|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104604|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104605|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104606|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104607|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104608|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104609|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104658|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104610|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104611|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104612|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104613|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104614|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104615|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104616|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104617|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104618|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104619|NCT01573767|E4|Reported Event|VI 25 OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104620|NCT01573767|E3|Reported Event|VI 12.5 OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104621|NCT01573767|E2|Reported Event|VI 6.25 OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104622|NCT01573767|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
104623|NCT01573325|B1|Baseline|Study Popoulation|There was only one group as this was a descriptive prospective study
104624|NCT01573325|P1|Participant Flow|Study Popoulation|There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
104625|NCT01573325|O1|Outcome|Population Predicted by Have Poor HRQOL by Depressive Symptoms|
104626|NCT01573325|O1|Outcome|Study Popoulation|There was only one group as this was a descriptive prospective study
104627|NCT01573325|E1|Reported Event|Study Popoulation|There was only one group as this was a descriptive prospective study
104628|NCT01573260|B3|Baseline|Total|Total of all reporting groups
104629|NCT01573260|B2|Baseline|Tango|
104630|NCT01573260|B1|Baseline|Control|
104631|NCT01573260|P2|Participant Flow|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104632|NCT01573260|P1|Participant Flow|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104633|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104634|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104635|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104636|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104777|NCT01572948|E2|Reported Event|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104637|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104638|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104639|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104640|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104641|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104642|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104643|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104644|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104645|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104646|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104647|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104648|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104649|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104650|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104651|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104652|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104653|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104654|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104655|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104656|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly class of argentinean tango for a period of 3-months the intervention for this arm~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104657|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104778|NCT01572948|E1|Reported Event|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104659|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104660|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104661|NCT01573260|E2|Reported Event|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
104662|NCT01573260|E1|Reported Event|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
104663|NCT01573000|B3|Baseline|Total|Total of all reporting groups
104664|NCT01573000|B2|Baseline|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104665|NCT01573000|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104666|NCT01573000|P2|Participant Flow|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104667|NCT01573000|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104668|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104669|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104670|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104671|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104779|NCT01572740|B3|Baseline|Total|Total of all reporting groups
104824|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
105643|NCT01568047|B2|Baseline|BIA 9-1067 (5 mg)|5 mg BIA 9-1067 - OPC, Opicapone
104672|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104673|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104674|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104675|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104676|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104677|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104678|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104679|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104680|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104681|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104682|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104695|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104683|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104684|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104685|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104686|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104687|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104688|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104689|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104690|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104691|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104692|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104693|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104694|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104696|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104697|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104698|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104699|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104700|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104701|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104702|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104703|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104704|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104705|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104706|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104820|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104821|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104707|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104708|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104709|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104710|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104711|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104712|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104713|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104714|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104715|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104716|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104717|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104754|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104718|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104719|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104720|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104721|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104722|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104723|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104724|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104725|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104726|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104727|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104728|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104729|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104822|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104730|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104731|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104732|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104733|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104734|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104735|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104736|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104737|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104738|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104739|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104740|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104741|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
105644|NCT01568047|B1|Baseline|Placebo|PLC, Placebo
104742|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104743|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104744|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104745|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104746|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104747|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104748|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104749|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104750|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104751|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104752|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104753|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104755|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104756|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104757|NCT01573000|E3|Reported Event|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104758|NCT01573000|E2|Reported Event|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104759|NCT01573000|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
104760|NCT01572948|B3|Baseline|Total|Total of all reporting groups
104761|NCT01572948|B2|Baseline|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104762|NCT01572948|B1|Baseline|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104763|NCT01572948|P2|Participant Flow|Placebo|500microgram white tablet
104764|NCT01572948|P1|Participant Flow|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
104765|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104766|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104767|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104768|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104769|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104770|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104771|NCT01572948|O2|Outcome|Placebo|500microgram white tablet
104772|NCT01572948|O1|Outcome|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
104773|NCT01572948|O2|Outcome|Daliresp|"The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models~roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models"
104774|NCT01572948|O1|Outcome|Placebo|"The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.~placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient"
104775|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
104776|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
104823|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104780|NCT01572740|B2|Baseline|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104781|NCT01572740|B1|Baseline|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104782|NCT01572740|P2|Participant Flow|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104783|NCT01572740|P1|Participant Flow|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104784|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104785|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104786|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104787|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104788|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104789|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104790|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104791|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104792|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104793|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104794|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104795|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104796|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104797|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104798|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104799|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104800|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104801|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104802|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104803|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104804|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104805|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104806|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104807|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104808|NCT01572740|E2|Reported Event|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104809|NCT01572740|E1|Reported Event|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
104810|NCT01572727|B3|Baseline|Total|Total of all reporting groups
104811|NCT01572727|B2|Baseline|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104812|NCT01572727|B1|Baseline|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104813|NCT01572727|P2|Participant Flow|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104814|NCT01572727|P1|Participant Flow|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104815|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104816|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104817|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104818|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104819|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
105645|NCT01568047|P4|Participant Flow|BIA 9-1067 (30 mg)|OPC, Opicapone
104825|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104826|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104827|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104828|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104829|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104830|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104831|NCT01572727|E2|Reported Event|Placebo 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
104832|NCT01572727|E1|Reported Event|Buparlisib (BKM120) 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
104833|NCT01572675|B3|Baseline|Total|Total of all reporting groups
104834|NCT01572675|B2|Baseline|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104835|NCT01572675|B1|Baseline|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104836|NCT01572675|P2|Participant Flow|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104837|NCT01572675|P1|Participant Flow|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104838|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104839|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104840|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104841|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104842|NCT01572675|O3|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104843|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104844|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104845|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104846|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104847|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104848|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104849|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104850|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104851|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104852|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104853|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104854|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104855|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104856|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104857|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104858|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104859|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104860|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104861|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104862|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104863|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104864|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104865|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104866|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104867|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104868|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104869|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104870|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104871|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104872|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104873|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104874|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104875|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104876|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104877|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104878|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104879|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104880|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104881|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104882|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104883|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104884|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104885|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104886|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104887|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104888|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104889|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104890|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104891|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104892|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104893|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104894|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104895|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104896|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104897|NCT01572675|O4|Outcome|More Than One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
104898|NCT01572675|O3|Outcome|From Three Months to One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year
104899|NCT01572675|O2|Outcome|From One to Three Months|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total
104900|NCT01572675|O1|Outcome|Up to Thirty Days|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days
104901|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104902|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
105013|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
104903|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104904|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104905|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104906|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104907|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104908|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104909|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104910|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104911|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104912|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104913|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104914|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104915|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104916|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104917|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104918|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104919|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104920|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104921|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104922|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104923|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104924|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104925|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104926|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104927|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104928|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104929|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104930|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104931|NCT01572675|E2|Reported Event|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104932|NCT01572675|E1|Reported Event|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
104933|NCT01572298|B3|Baseline|Total|Total of all reporting groups
104934|NCT01572298|B2|Baseline|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104935|NCT01572298|B1|Baseline|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104936|NCT01572298|P2|Participant Flow|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104937|NCT01572298|P1|Participant Flow|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104938|NCT01572298|O2|Outcome|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104939|NCT01572298|O1|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104940|NCT01572298|E2|Reported Event|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104941|NCT01572298|E1|Reported Event|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
104942|NCT01572207|B3|Baseline|Total|Total of all reporting groups
104943|NCT01572207|B2|Baseline|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104944|NCT01572207|B1|Baseline|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
104945|NCT01572207|P2|Participant Flow|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104946|NCT01572207|P1|Participant Flow|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
104947|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104948|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
105014|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
104949|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104950|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
104951|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104952|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
104953|NCT01572207|E2|Reported Event|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
104954|NCT01572207|E1|Reported Event|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
104955|NCT01571557|B1|Baseline|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104956|NCT01571557|P1|Participant Flow|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104957|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104958|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104959|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104960|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104961|NCT01571557|E1|Reported Event|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
104962|NCT01571453|B3|Baseline|Total|Total of all reporting groups
104963|NCT01571453|B2|Baseline|Venlafaxine|Venlafaxine extended release: 150 mg/day
104964|NCT01571453|B1|Baseline|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104965|NCT01571453|P2|Participant Flow|Venlafaxine|Venlafaxine extended release 150 mg/day
104966|NCT01571453|P1|Participant Flow|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104967|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104968|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104969|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104970|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104971|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104972|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104973|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104974|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104975|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104976|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104977|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
104978|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104979|NCT01571453|E2|Reported Event|Venlafaxine|Venlafaxine extended release: 150 mg/day
104980|NCT01571453|E1|Reported Event|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
104981|NCT01570751|B3|Baseline|Total|Total of all reporting groups
104982|NCT01570751|B2|Baseline|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104983|NCT01570751|B1|Baseline|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104984|NCT01570751|P2|Participant Flow|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
105646|NCT01568047|P3|Participant Flow|BIA 9-1067 (15 mg)|OPC, Opicapone
104985|NCT01570751|P1|Participant Flow|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104986|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
104987|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
104988|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104989|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104990|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
104991|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
104992|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104993|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
104994|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
104995|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
104996|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
104997|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
104998|NCT01570751|E2|Reported Event|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
104999|NCT01570751|E1|Reported Event|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
105000|NCT01570686|B3|Baseline|Total|Total of all reporting groups
105001|NCT01570686|B2|Baseline|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105002|NCT01570686|B1|Baseline|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105003|NCT01570686|P2|Participant Flow|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105004|NCT01570686|P1|Participant Flow|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105005|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105006|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105007|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105008|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105009|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105010|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105011|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105012|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105015|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105016|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105017|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105018|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105019|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105020|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105021|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105022|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105023|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105024|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105025|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
105026|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105027|NCT01570686|E2|Reported Event|Aliskiren 300 mg (Fasted)|Aliskiren 300 mg once daily taken after after an overnight fast
105028|NCT01570686|E1|Reported Event|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
105029|NCT01570634|B1|Baseline|Open Label CASAD|Treatment with CASAD for 14 days
105030|NCT01570634|P1|Participant Flow|Open Label CASAD|Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
105031|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
105032|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
105033|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
105034|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
105035|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
105036|NCT01570634|E1|Reported Event|Open Label CASAD|Treatment with CASAD for 14 days
105037|NCT01570309|B3|Baseline|Total|Total of all reporting groups
105038|NCT01570309|B2|Baseline|Sugar Pill|Matching placebo
105039|NCT01570309|B1|Baseline|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105040|NCT01570309|P2|Participant Flow|Sugar Pill|Matching placebo
105041|NCT01570309|P1|Participant Flow|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105042|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
105043|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105044|NCT01570309|O2|Outcome|Placebo|Sugar Pill
105045|NCT01570309|O1|Outcome|Active Therapy|Ergocalciferol 50,000 U q weekly x 12 weeks
105046|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
105047|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105048|NCT01570309|O2|Outcome|Sugar Pill|Matching Placebo
105049|NCT01570309|O1|Outcome|Active|Ergocalciferal 50,000 U qweekly x 12 weeks
105050|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
105051|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105052|NCT01570309|E2|Reported Event|Sugar Pill|Matching placebo
105053|NCT01570309|E1|Reported Event|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
105054|NCT01570244|B1|Baseline|All Subjects|The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
105055|NCT01570244|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.~Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.~Period 2: Microgynon tablets and Faldaprevir."
105056|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105057|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105058|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105059|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105060|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105061|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105062|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105063|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105064|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105065|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105066|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105067|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105068|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105069|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105070|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105071|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105072|NCT01570244|E2|Reported Event|Microgynon + BI 201335|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
105073|NCT01570244|E1|Reported Event|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
105074|NCT01569841|B1|Baseline|Full Analysis Set|The full analysis set (FAS) included all randomised subjects.
105075|NCT01569841|P2|Participant Flow|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
105076|NCT01569841|P1|Participant Flow|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
105077|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
105078|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
105079|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
105080|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
105116|NCT01569815|B1|Baseline|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105117|NCT01569815|P4|Participant Flow|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105081|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
105082|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
105083|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
105084|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
105085|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
105086|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
105087|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
105088|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
105118|NCT01569815|P3|Participant Flow|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105119|NCT01569815|P2|Participant Flow|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105120|NCT01569815|P1|Participant Flow|Mild Renal Impaired|LCZ696 400 mg once daily for 5 days
105121|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105089|NCT01569841|E2|Reported Event|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
105090|NCT01569841|E1|Reported Event|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
105091|NCT01569828|B3|Baseline|Total|Total of all reporting groups
105092|NCT01569828|B2|Baseline|Matched Healthy Volunteers|"All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
105093|NCT01569828|B1|Baseline|Severe Renal Impaired Subjects|"Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
105094|NCT01569828|P2|Participant Flow|Matched Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
105095|NCT01569828|P1|Participant Flow|Severe Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105096|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105097|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days
105098|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105099|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105122|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105123|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105124|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105100|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105101|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105102|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105103|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105104|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105105|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105106|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105107|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105108|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105109|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
105110|NCT01569828|E2|Reported Event|Matched Healthy Volunteers|
105111|NCT01569828|E1|Reported Event|Severe Renal Impaired Patients|
105112|NCT01569815|B5|Baseline|Total|Total of all reporting groups
105113|NCT01569815|B4|Baseline|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105114|NCT01569815|B3|Baseline|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105115|NCT01569815|B2|Baseline|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105125|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105126|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105127|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105128|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105129|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105130|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105131|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105132|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105133|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105134|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105135|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105136|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105137|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105138|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105139|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105140|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105141|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105142|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105143|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105144|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105145|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105146|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105147|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105148|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105149|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105150|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105151|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105152|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105153|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105154|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105155|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
105156|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
105157|NCT01569815|E5|Reported Event|LCZ696 400 mg - All Healthy Subjects|LCZ696 400 mg - All healthy subjects
105158|NCT01569815|E4|Reported Event|LCZ696 400 mg - Moderate - Matched Healthy Subjects|LCZ696 400 mg - Moderate - Matched healthy subjects
105159|NCT01569815|E3|Reported Event|LCZ696 400 mg - Moderate - Renal Impaired Patients|LCZ696 400 mg - Moderate - Renal impaired patients
105160|NCT01569815|E2|Reported Event|LCZ696 400 mg - Mild - Matched Healthy Subjects|LCZ696 400 mg - Mild - Matched healthy subjects
105161|NCT01569815|E1|Reported Event|LCZ696 400 mg - Mild - Renal Impaired Patients|LCZ696 400 mg - Mild - Renal impaired patients
105162|NCT01569763|B3|Baseline|Total|Total of all reporting groups
105163|NCT01569763|B2|Baseline|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105164|NCT01569763|B1|Baseline|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system
105165|NCT01569763|P2|Participant Flow|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105166|NCT01569763|P1|Participant Flow|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
105167|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105168|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
105169|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105170|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
105171|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105172|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
105173|NCT01569763|E2|Reported Event|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
105174|NCT01569763|E1|Reported Event|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
105175|NCT01569529|B3|Baseline|Total|Total of all reporting groups
105176|NCT01569529|B2|Baseline|No ad Exposure|Young adults, who registered for the cessation program, one month prior to presenting the online advertisements (intervention).
105177|NCT01569529|B1|Baseline|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
105375|NCT01569074|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105376|NCT01569074|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
105178|NCT01569529|P2|Participant Flow|No Ad Exposure|Young adults, who registered for the cessation program, after arriving at the program site though established means (e.g., search engine results), one month prior to presenting the tailored online advertisements (intervention).
105179|NCT01569529|P1|Participant Flow|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
105180|NCT01569529|O2|Outcome|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
105181|NCT01569529|O1|Outcome|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
105182|NCT01569529|E2|Reported Event|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
105183|NCT01569529|E1|Reported Event|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
105184|NCT01569464|B3|Baseline|Total|Total of all reporting groups
105185|NCT01569464|B2|Baseline|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105186|NCT01569464|B1|Baseline|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105187|NCT01569464|P2|Participant Flow|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105188|NCT01569464|P1|Participant Flow|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105189|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105190|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105191|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105192|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105193|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105194|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105195|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105196|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105197|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105198|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105199|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105200|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105377|NCT01568905|B4|Baseline|Total|Total of all reporting groups
105647|NCT01568047|P2|Participant Flow|BIA 9-1067 (5 mg)|OPC, Opicapone
105201|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105202|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105203|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105204|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105205|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105206|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105207|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105208|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105209|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105210|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105211|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105212|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105213|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105214|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105215|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105216|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105217|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105218|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105219|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105220|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105221|NCT01569464|E2|Reported Event|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
105648|NCT01568047|P1|Participant Flow|Placebo|PLC, Placebo
105222|NCT01569464|E1|Reported Event|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
105223|NCT01569438|B3|Baseline|Total|Total of all reporting groups
105224|NCT01569438|B2|Baseline|Sugar Pill|Sugar Pill: Placebo
105225|NCT01569438|B1|Baseline|AF-219|AF-219: BID
105226|NCT01569438|P2|Participant Flow|AF-219|AF-219: BID
105227|NCT01569438|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo
105228|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
105229|NCT01569438|O1|Outcome|AF-219|AF-219: BID
105230|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
105231|NCT01569438|O1|Outcome|AF-219|AF-219: BID
105232|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
105233|NCT01569438|O1|Outcome|AF-219|AF-219: BID
105234|NCT01569438|O2|Outcome|AF-219|AF-219: BID
105235|NCT01569438|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
105236|NCT01569438|E2|Reported Event|AF-219|AF-219: BID
105237|NCT01569438|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo
105238|NCT01569126|B7|Baseline|Total|Total of all reporting groups
105239|NCT01569126|B6|Baseline|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105240|NCT01569126|B5|Baseline|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105241|NCT01569126|B4|Baseline|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105242|NCT01569126|B3|Baseline|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105243|NCT01569126|B2|Baseline|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105244|NCT01569126|B1|Baseline|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105245|NCT01569126|P6|Participant Flow|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105246|NCT01569126|P5|Participant Flow|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105247|NCT01569126|P4|Participant Flow|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105248|NCT01569126|P3|Participant Flow|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105249|NCT01569126|P2|Participant Flow|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105250|NCT01569126|P1|Participant Flow|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105251|NCT01569126|O6|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105252|NCT01569126|O5|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105253|NCT01569126|O4|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105254|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105255|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105256|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105257|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105258|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105259|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105260|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105261|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105262|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105263|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105264|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105265|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105266|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105267|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105268|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105269|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105270|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105271|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105272|NCT01569126|O3|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105273|NCT01569126|O2|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105274|NCT01569126|O1|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105275|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105276|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105277|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105278|NCT01569126|E6|Reported Event|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105279|NCT01569126|E5|Reported Event|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105280|NCT01569126|E4|Reported Event|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
105281|NCT01569126|E3|Reported Event|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
105282|NCT01569126|E2|Reported Event|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105283|NCT01569126|E1|Reported Event|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
105284|NCT01569087|B4|Baseline|Total|Total of all reporting groups
105285|NCT01569087|B3|Baseline|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105286|NCT01569087|B2|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105287|NCT01569087|B1|Baseline|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105378|NCT01568905|B3|Baseline|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week
105649|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
105288|NCT01569087|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105289|NCT01569087|P2|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105290|NCT01569087|P1|Participant Flow|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105291|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105292|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105293|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105294|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105295|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105296|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105297|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105298|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105299|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105300|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105301|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105302|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105303|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105304|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105305|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105306|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105307|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105308|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105309|NCT01569087|E3|Reported Event|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
105310|NCT01569087|E2|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105311|NCT01569087|E1|Reported Event|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
105312|NCT01569074|B6|Baseline|Total|Total of all reporting groups
105313|NCT01569074|B5|Baseline|PLACEBO PO|Dosing Group E
105314|NCT01569074|B4|Baseline|FOSTA 50 MG BID PO|Dosing Group D
105315|NCT01569074|B3|Baseline|FOSTA 75 MG BID PO|Dosing Group C
105316|NCT01569074|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105317|NCT01569074|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
105318|NCT01569074|P5|Participant Flow|PLACEBO PO|Dosing Group E
105319|NCT01569074|P4|Participant Flow|FOSTA 50 MG BID PO|Dosing Group D
105320|NCT01569074|P3|Participant Flow|FOSTA 75 MG BID PO|Dosing Group C
105321|NCT01569074|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105322|NCT01569074|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
105323|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105324|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105325|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105326|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105327|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105328|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105329|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105330|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105331|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105332|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105333|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105334|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105335|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105336|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105337|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105338|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105339|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105340|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105341|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105342|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105343|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105344|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105345|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105346|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105347|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105348|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105349|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105350|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105351|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105352|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105353|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105354|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105355|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105356|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105357|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105358|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105359|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105360|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105361|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105362|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105363|NCT01569074|O4|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105364|NCT01569074|O3|Outcome|PLACEBO PO|Dosing Group E
105365|NCT01569074|O2|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105366|NCT01569074|O1|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105367|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
105368|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
105369|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
105370|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
105371|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
105372|NCT01569074|E5|Reported Event|PLACEBO PO|Dosing Group E
105373|NCT01569074|E4|Reported Event|FOSTA 75 MG BID PO|Dosing Group C
105374|NCT01569074|E3|Reported Event|FOSTA 50 MG BID PO|Dosing Group D
105379|NCT01568905|B2|Baseline|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
105380|NCT01568905|B1|Baseline|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week
105381|NCT01568905|P3|Participant Flow|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105382|NCT01568905|P2|Participant Flow|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105383|NCT01568905|P1|Participant Flow|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105384|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105385|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105386|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105387|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105388|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105389|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105390|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105391|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105392|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105393|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105394|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105395|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105396|NCT01568905|E3|Reported Event|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
105397|NCT01568905|E2|Reported Event|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
105398|NCT01568905|E1|Reported Event|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
105399|NCT01568892|B3|Baseline|Total|Total of all reporting groups
105400|NCT01568892|B2|Baseline|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105401|NCT01568892|B1|Baseline|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105402|NCT01568892|P2|Participant Flow|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105403|NCT01568892|P1|Participant Flow|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105404|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105405|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105406|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105407|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105408|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105448|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105409|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105410|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105411|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105412|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105413|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105414|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105415|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105416|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105417|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105418|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105419|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105420|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105421|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105422|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105423|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105424|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105425|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105426|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105484|NCT01568112|P4|Participant Flow|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105427|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105428|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105429|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105430|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105431|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105432|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105433|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105434|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105435|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105436|NCT01568892|E2|Reported Event|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105437|NCT01568892|E1|Reported Event|DTG 50mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
105438|NCT01568866|B3|Baseline|Total|Total of all reporting groups
105439|NCT01568866|B2|Baseline|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105440|NCT01568866|B1|Baseline|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105441|NCT01568866|P2|Participant Flow|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105442|NCT01568866|P1|Participant Flow|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105443|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105444|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105445|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105446|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105447|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105449|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105450|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105451|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105452|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105453|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105454|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105455|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105456|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105457|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105458|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105459|NCT01568866|E2|Reported Event|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
105460|NCT01568866|E1|Reported Event|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
105461|NCT01568827|B3|Baseline|Total|Total of all reporting groups
105462|NCT01568827|B2|Baseline|No Intervention|Water without lypholized black raspberry powder
105463|NCT01568827|B1|Baseline|Black-raspberry Powder|Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
105464|NCT01568827|P2|Participant Flow|Blackraspberry Slurry First, Then Washout, Then Water|Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
105465|NCT01568827|P1|Participant Flow|Water First, Then Washout, Then Blackraspberry Slurry|8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
105466|NCT01568827|O2|Outcome|Blackraspberry Slurry|Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
105467|NCT01568827|O1|Outcome|Water|Water without lypholized black raspberry powder
105468|NCT01568827|E2|Reported Event|Water, Washout, Black-raspberry Slurry|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
105469|NCT01568827|E1|Reported Event|Black-raspberry Slurry, Washout, Water|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
105470|NCT01568593|B3|Baseline|Total|Total of all reporting groups
105471|NCT01568593|B2|Baseline|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
105472|NCT01568593|B1|Baseline|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
105473|NCT01568593|P2|Participant Flow|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
105474|NCT01568593|P1|Participant Flow|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
105475|NCT01568593|O2|Outcome|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
105476|NCT01568593|O1|Outcome|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
105477|NCT01568593|E2|Reported Event|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
105478|NCT01568593|E1|Reported Event|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
105479|NCT01568112|B5|Baseline|Total|Total of all reporting groups
105480|NCT01568112|B4|Baseline|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105481|NCT01568112|B3|Baseline|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105482|NCT01568112|B2|Baseline|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105483|NCT01568112|B1|Baseline|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105485|NCT01568112|P3|Participant Flow|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105486|NCT01568112|P2|Participant Flow|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105487|NCT01568112|P1|Participant Flow|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105488|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105489|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105490|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105491|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105492|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105493|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105494|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105495|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105496|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105497|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105498|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105499|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105500|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105501|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105502|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105503|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105504|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105505|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105506|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105507|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105508|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105509|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105510|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105511|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105512|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105513|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105514|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105515|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105547|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105516|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105517|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105518|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105519|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105520|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105521|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105522|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105523|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105524|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105525|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105526|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105527|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105528|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105529|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105530|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105531|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105532|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105533|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105534|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105535|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105536|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105537|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105538|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105539|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105540|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105541|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105542|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105543|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105544|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105545|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105546|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105623|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
105548|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105549|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105550|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105551|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105552|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105553|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105554|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105555|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105556|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105557|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105558|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105559|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105560|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105561|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105562|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105563|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105564|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105565|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105566|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105567|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105568|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105569|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105570|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105571|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105572|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105573|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105574|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105575|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105576|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105577|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105578|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105624|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
105579|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105580|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105581|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105582|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105583|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105584|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105585|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105586|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105587|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105588|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105589|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105590|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105591|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105592|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105593|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105594|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105595|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105596|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105597|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105598|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105599|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105600|NCT01568112|E4|Reported Event|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
105601|NCT01568112|E3|Reported Event|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
105602|NCT01568112|E2|Reported Event|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
105603|NCT01568112|E1|Reported Event|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
105604|NCT01568073|B6|Baseline|Total|Total of all reporting groups
105605|NCT01568073|B5|Baseline|OPC 50mg|OPC, Opicapone 50mg
105606|NCT01568073|B4|Baseline|OPC 25mg|OPC, Opicapone 25mg
105607|NCT01568073|B3|Baseline|OPC 5mg|OPC, Opicapone 5mg
105608|NCT01568073|B2|Baseline|Entacapone|Entacapone - 200 mg
105609|NCT01568073|B1|Baseline|Placebo|Placebo 200 mg
105610|NCT01568073|P5|Participant Flow|OPC 50mg|OPC, Opicapone 50mg
105611|NCT01568073|P4|Participant Flow|OPC 25mg|OPC, Opicapone 25mg
105612|NCT01568073|P3|Participant Flow|OPC 5mg|OPC, Opicapone 5mg
105613|NCT01568073|P2|Participant Flow|Entacapone|Entacapone - 200 mg
105614|NCT01568073|P1|Participant Flow|Placebo|Placebo 200 mg
105615|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
105616|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
105617|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
105618|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
105619|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
105620|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
105621|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
105622|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
105650|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
105651|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
105652|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
105653|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
105654|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
105655|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
105656|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
105657|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
105658|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
105659|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
105660|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
105661|NCT01568047|E4|Reported Event|BIA 9-1067 (30 mg)|30 mg BIA 9-1067, OPC, Opicapone
105662|NCT01568047|E3|Reported Event|BIA 9-1067 (15 mg)|15 mg BIA 9-1067, OPC, Opicapone
105663|NCT01568047|E2|Reported Event|BIA 9-1067 (5 mg)|5 mg BIA 9-1067, OPC, Opicapone
105664|NCT01568047|E1|Reported Event|Placebo|Placebo, PLC
105665|NCT01568034|B1|Baseline|Overall Study|The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
105666|NCT01568034|P4|Participant Flow|Treatment Sequence D|"Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
105667|NCT01568034|P3|Participant Flow|Treatment Sequence C|"Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
105668|NCT01568034|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
105669|NCT01568034|P1|Participant Flow|Treatment Sequence A|"Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
105670|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
105671|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
105672|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
105673|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
105674|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
105675|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
105676|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
105677|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
105678|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
105679|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
105680|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
105681|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
105682|NCT01568034|E4|Reported Event|Placebo|Placebo ESL, Eslicarbazepine
105683|NCT01568034|E3|Reported Event|100 mg BIA 9-1067|100 mg BIA 9-1067 ESL, Eslicarbazepine
105684|NCT01568034|E2|Reported Event|50 mg BIA 9-1067|50 mg BIA 9-1067 ESL, Eslicarbazepine
105685|NCT01568034|E1|Reported Event|25 mg BIA 9-1067|25 mg BIA 9-1067 ESL, Eslicarbazepine
105686|NCT01568021|B1|Baseline|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105687|NCT01568021|P1|Participant Flow|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105688|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105689|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105690|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105691|NCT01568021|E1|Reported Event|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
105692|NCT01568008|B1|Baseline|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105693|NCT01568008|P1|Participant Flow|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105694|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105695|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105696|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105697|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105698|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105878|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105699|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105700|NCT01568008|E1|Reported Event|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
105701|NCT01567943|B3|Baseline|Total|Total of all reporting groups
105702|NCT01567943|B2|Baseline|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
105703|NCT01567943|B1|Baseline|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
105704|NCT01567943|P2|Participant Flow|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
105705|NCT01567943|P1|Participant Flow|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
105706|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
105707|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
105708|NCT01567943|E2|Reported Event|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
105709|NCT01567943|E1|Reported Event|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
105710|NCT01567852|B3|Baseline|Total|Total of all reporting groups
105711|NCT01567852|B2|Baseline|Methohexital First|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
105712|NCT01567852|B1|Baseline|Ketamine First|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
105713|NCT01567852|P2|Participant Flow|Methohexital Then Ketamine (Alternating Each Trial)|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
105714|NCT01567852|P1|Participant Flow|Ketamine Then Methohexital (Alternating Each Trial)|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
105715|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
105716|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
105717|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
105718|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
105719|NCT01567852|E2|Reported Event|Methohexital Inductions|Number of trials receiving methohexital inductions. Each trial is one induction
105720|NCT01567852|E1|Reported Event|Ketamine Inductions|Number of trials receiving ketamine inductions. Each trial is one induction.
105721|NCT01567839|B1|Baseline|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
105722|NCT01567839|P1|Participant Flow|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
105723|NCT01567839|O3|Outcome|4% Prilocaine With 1:200,000 Epinephrine|
105724|NCT01567839|O2|Outcome|4% Lidocaine With 1:100,000 Epinephrine|
105725|NCT01567839|O1|Outcome|4% Articaine With 1:100,000 Epinephrine|
105726|NCT01567839|E3|Reported Event|4% Prilocaine With 1:200,000 Epinephrine|
105727|NCT01567839|E2|Reported Event|4% Lidocaine With 1:100,000 Epinephrine|
105728|NCT01567839|E1|Reported Event|4% Articaine With 1:100,000 Epinephrine|
105729|NCT01567371|B1|Baseline|LiDCO Rapid Monitor|
105730|NCT01567371|P1|Participant Flow|LiDCO Rapid Monitor|
105731|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
105732|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
105733|NCT01567371|E1|Reported Event|LiDCO Rapid Monitor|
105734|NCT01567163|B1|Baseline|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
105735|NCT01567163|P1|Participant Flow|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
105736|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105737|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105738|NCT01567163|O1|Outcome|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
105879|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105739|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105740|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105741|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105742|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
105743|NCT01567163|E1|Reported Event|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
105744|NCT01567150|B3|Baseline|Total|Total of all reporting groups
105745|NCT01567150|B2|Baseline|Control|Control is treatment without novel dressing
105746|NCT01567150|B1|Baseline|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
105747|NCT01567150|P2|Participant Flow|Control|Control is treatment without novel dressing
105748|NCT01567150|P1|Participant Flow|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
105749|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
105750|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
105751|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
105752|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
105753|NCT01567150|E2|Reported Event|Control|Control is treatment without novel dressing
105754|NCT01567150|E1|Reported Event|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
105755|NCT01567020|B5|Baseline|Total|Total of all reporting groups
105756|NCT01567020|B4|Baseline|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105757|NCT01567020|B3|Baseline|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105758|NCT01567020|B2|Baseline|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105759|NCT01567020|B1|Baseline|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105760|NCT01567020|P4|Participant Flow|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105761|NCT01567020|P3|Participant Flow|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105762|NCT01567020|P2|Participant Flow|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105763|NCT01567020|P1|Participant Flow|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105764|NCT01567020|O4|Outcome|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105765|NCT01567020|O3|Outcome|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105766|NCT01567020|O2|Outcome|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105767|NCT01567020|O1|Outcome|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105768|NCT01567020|E4|Reported Event|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105769|NCT01567020|E3|Reported Event|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105770|NCT01567020|E2|Reported Event|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105771|NCT01567020|E1|Reported Event|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
105772|NCT01566981|B3|Baseline|Total|Total of all reporting groups
105773|NCT01566981|B2|Baseline|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
105831|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105832|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105774|NCT01566981|B1|Baseline|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
105775|NCT01566981|P2|Participant Flow|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up, so 54 patients were included in final analysis."
105776|NCT01566981|P1|Participant Flow|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
105777|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
105778|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
105779|NCT01566981|O2|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
105780|NCT01566981|O1|Outcome|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
105781|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
105782|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
105783|NCT01566981|E2|Reported Event|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis."
105784|NCT01566981|E1|Reported Event|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis"
105785|NCT01566838|B3|Baseline|Total|Total of all reporting groups
105786|NCT01566838|B2|Baseline|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105787|NCT01566838|B1|Baseline|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105788|NCT01566838|P2|Participant Flow|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105789|NCT01566838|P1|Participant Flow|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105790|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105791|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105792|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105793|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105794|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105795|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105833|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105834|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105835|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105836|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105796|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105797|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105798|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105799|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105800|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105801|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105802|NCT01566838|E2|Reported Event|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
105837|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105838|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105880|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105881|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105803|NCT01566838|E1|Reported Event|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
105804|NCT01566630|B3|Baseline|Total|Total of all reporting groups
105805|NCT01566630|B2|Baseline|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
105806|NCT01566630|B1|Baseline|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
105807|NCT01566630|P2|Participant Flow|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
105808|NCT01566630|P1|Participant Flow|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
105809|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105810|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105811|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105812|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105813|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105814|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105815|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105816|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105817|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105818|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105819|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105820|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105821|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105822|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105823|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105824|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105825|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105826|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105827|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105828|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105829|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105830|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105877|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105839|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105840|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105841|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105842|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105843|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105844|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105845|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105846|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105847|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105848|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105849|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105850|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105851|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105852|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105853|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105854|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105855|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105856|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105857|NCT01566630|E4|Reported Event|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
105858|NCT01566630|E3|Reported Event|Placebo- Maternal|Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
105859|NCT01566630|E2|Reported Event|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
105860|NCT01566630|E1|Reported Event|RLX030- Maternal|Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
105861|NCT01566604|B3|Baseline|Total|Total of all reporting groups
105862|NCT01566604|B2|Baseline|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105863|NCT01566604|B1|Baseline|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105864|NCT01566604|P2|Participant Flow|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105865|NCT01566604|P1|Participant Flow|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105866|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105867|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105868|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105869|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105870|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105871|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105872|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105873|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105874|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105875|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105876|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105882|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105883|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105884|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105885|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105886|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105887|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105888|NCT01566604|E2|Reported Event|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
105889|NCT01566604|E1|Reported Event|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
105890|NCT01566526|B1|Baseline|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105891|NCT01566526|P1|Participant Flow|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105892|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105893|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105894|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105895|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105896|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105897|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105898|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105899|NCT01566526|E1|Reported Event|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
105900|NCT01566500|B1|Baseline|Study Sample|Adults with self-reported epilepsy.
105901|NCT01566500|P1|Participant Flow|Study Sample|Adults with self-reported epilepsy.
105902|NCT01566500|O1|Outcome|Study Sample|Adults with self-reported epilepsy.
105903|NCT01566500|E1|Reported Event|Study Sample|Adults with self-reported epilepsy.
105904|NCT01566461|B3|Baseline|Total|Total of all reporting groups
105905|NCT01566461|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105906|NCT01566461|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105907|NCT01566461|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105908|NCT01566461|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105909|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105910|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105911|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105912|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105913|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105914|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105915|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105916|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105917|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105918|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105919|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105920|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105921|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105922|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105923|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105924|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105925|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105926|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105927|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105928|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105929|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105930|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105931|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105932|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105933|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105934|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105935|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105936|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105937|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105938|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105939|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105940|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105941|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105942|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105943|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105944|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105945|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105946|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105947|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105948|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
105949|NCT01566461|E2|Reported Event|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105950|NCT01566461|E1|Reported Event|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
105951|NCT01566435|B1|Baseline|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105952|NCT01566435|P1|Participant Flow|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
105953|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105954|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105955|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105956|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105957|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
105958|NCT01566435|E3|Reported Event|ACF Definitive Chemoradiation Therapy-cetuximab|"Definitive Therapy~Cetuximab 250 mg/m^2 IV weekly for 8 weeks~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
105959|NCT01566435|E2|Reported Event|ACF Definitive Chemoradiation Therapy-cisplatin|"Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
105960|NCT01566435|E1|Reported Event|ACF Induction Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF."
105961|NCT01566409|B3|Baseline|Total|Total of all reporting groups
105962|NCT01566409|B2|Baseline|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
105963|NCT01566409|B1|Baseline|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
105964|NCT01566409|P2|Participant Flow|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
105965|NCT01566409|P1|Participant Flow|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
105966|NCT01566409|O2|Outcome|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
105967|NCT01566409|O1|Outcome|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
105968|NCT01566409|E2|Reported Event|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
105969|NCT01566409|E1|Reported Event|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
105970|NCT01566370|B3|Baseline|Total|Total of all reporting groups
105971|NCT01566370|B2|Baseline|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105972|NCT01566370|B1|Baseline|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105973|NCT01566370|P2|Participant Flow|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105974|NCT01566370|P1|Participant Flow|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105975|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105976|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105977|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105978|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105979|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105980|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105981|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
106016|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
105982|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105983|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105984|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105985|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105986|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105987|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105988|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105989|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105990|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105991|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105992|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105993|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105994|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105995|NCT01566370|E2|Reported Event|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
105996|NCT01566370|E1|Reported Event|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
105997|NCT01566331|B3|Baseline|Total|Total of all reporting groups
105998|NCT01566331|B2|Baseline|Baby-guardTM With Minimal Inflation|Baby-guardTM system, with minimal inflation in women who expected natural delivery
105999|NCT01566331|B1|Baseline|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
106000|NCT01566331|P2|Participant Flow|Baby-guardTM Minimal Inflation|Baby-guardTM with minimal inflation who expected natural delivery
106001|NCT01566331|P1|Participant Flow|Baby-guardTM|"Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes~Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes"
106002|NCT01566331|O2|Outcome|Baby-guardTM With Minimal Inflation|
106003|NCT01566331|O1|Outcome|Baby Belt Device Group|
106004|NCT01566331|E2|Reported Event|Baby Birth With Minimal Inflation|group delivering with dwvice and minimal inflation
106005|NCT01566331|E1|Reported Event|Baby Birth|group delivering with baby birth
106006|NCT01566162|B1|Baseline|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106007|NCT01566162|P1|Participant Flow|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106008|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106009|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106010|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106011|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106012|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106013|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106014|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106015|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106017|NCT01566162|E1|Reported Event|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
106018|NCT01566149|B3|Baseline|Total|Total of all reporting groups
106019|NCT01566149|B2|Baseline|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106020|NCT01566149|B1|Baseline|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106021|NCT01566149|P2|Participant Flow|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106022|NCT01566149|P1|Participant Flow|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106023|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106024|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106025|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106026|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106027|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106028|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106029|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106030|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106031|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106032|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106033|NCT01566149|E2|Reported Event|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
106034|NCT01566149|E1|Reported Event|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
106035|NCT01566084|B3|Baseline|Total|Total of all reporting groups
106036|NCT01566084|B2|Baseline|Placebo (Start)|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the slow sodium tablet arm in the second half of the study."
106037|NCT01566084|B1|Baseline|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.~Subjects then cross-over to the placebo arm in the second half of the study."
106038|NCT01566084|P2|Participant Flow|Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the opposite condition in the second half of the study."
106039|NCT01566084|P1|Participant Flow|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~Subjects then cross over to the opposite condition in the second half of the study."
106040|NCT01566084|O4|Outcome|Low Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
106041|NCT01566084|O3|Outcome|Normal Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
106042|NCT01566084|O2|Outcome|Low Sodium Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
106043|NCT01566084|O1|Outcome|Normal Sodium Placebo|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
106044|NCT01566084|O4|Outcome|Low Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
106045|NCT01566084|O3|Outcome|Normal Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
106046|NCT01566084|O2|Outcome|Low Sodium Saline|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
106047|NCT01566084|O1|Outcome|Normal Sodium Saline|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
106048|NCT01566084|O2|Outcome|Low Sodium Diet.|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
106049|NCT01566084|O1|Outcome|Normal Sodium Diet|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.
106050|NCT01566084|E2|Reported Event|Low Sodium|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
106051|NCT01566084|E1|Reported Event|Normal Sodium|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
106052|NCT01565993|B3|Baseline|Total|Total of all reporting groups
106053|NCT01565993|B2|Baseline|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
106601|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106054|NCT01565993|B1|Baseline|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
106055|NCT01565993|P2|Participant Flow|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
106056|NCT01565993|P1|Participant Flow|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
106057|NCT01565993|O2|Outcome|Conventional Polipectomy|In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.
106058|NCT01565993|O1|Outcome|Hemoclip|"In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
106059|NCT01565993|E2|Reported Event|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
106060|NCT01565993|E1|Reported Event|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
106061|NCT01565980|B3|Baseline|Total|Total of all reporting groups
106062|NCT01565980|B2|Baseline|Mindfulness Intervention|"Participants receive weekly symptom assessment phone calls.~Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention."
106063|NCT01565980|B1|Baseline|Attention Control|weekly symptom assessment phone calls.
106064|NCT01565980|P2|Participant Flow|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
106065|NCT01565980|P1|Participant Flow|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
106066|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
106067|NCT01565980|O1|Outcome|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
106068|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks."
106069|NCT01565980|O1|Outcome|Symptom Assessment|"6 weeks of symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks."
106070|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
106071|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
106072|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
106073|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
106074|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
106075|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
106076|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
106077|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
106078|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
106079|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
106080|NCT01565980|E2|Reported Event|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention."
106081|NCT01565980|E1|Reported Event|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
106082|NCT01565902|B5|Baseline|Total|Total of all reporting groups
106083|NCT01565902|B4|Baseline|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
106084|NCT01565902|B3|Baseline|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106085|NCT01565902|B2|Baseline|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106086|NCT01565902|B1|Baseline|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106087|NCT01565902|P4|Participant Flow|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
106088|NCT01565902|P3|Participant Flow|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106089|NCT01565902|P2|Participant Flow|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106090|NCT01565902|P1|Participant Flow|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106091|NCT01565902|O4|Outcome|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
106092|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106093|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106094|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106095|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
106096|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
106097|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
106098|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106099|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106100|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106101|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
106102|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
106103|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
106104|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106105|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106106|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106107|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
106108|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
106109|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
106110|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106111|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106112|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106113|NCT01565902|E4|Reported Event|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106114|NCT01565902|E3|Reported Event|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
106115|NCT01565902|E2|Reported Event|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106116|NCT01565902|E1|Reported Event|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
106117|NCT01565889|B7|Baseline|Total|Total of all reporting groups
106118|NCT01565889|B6|Baseline|Part B: SOF+PEG+RBV|"SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.~This reporting group presents data for those participants who joined the study for Part B only."
106119|NCT01565889|B5|Baseline|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106120|NCT01565889|B4|Baseline|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106121|NCT01565889|B3|Baseline|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106122|NCT01565889|B2|Baseline|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106123|NCT01565889|B1|Baseline|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106124|NCT01565889|P6|Participant Flow|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106125|NCT01565889|P5|Participant Flow|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106126|NCT01565889|P4|Participant Flow|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106127|NCT01565889|P3|Participant Flow|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106128|NCT01565889|P2|Participant Flow|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106129|NCT01565889|P1|Participant Flow|Part A: SOF+EFV/FTC/TDF (Cohort 1)|Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106188|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106130|NCT01565889|O6|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106131|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106132|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106133|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106134|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106135|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106136|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106137|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106138|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106139|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106140|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106141|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106142|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106143|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106144|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106145|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106146|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106147|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106148|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106149|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106150|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106151|NCT01565889|E6|Reported Event|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
106152|NCT01565889|E5|Reported Event|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
106153|NCT01565889|E4|Reported Event|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106322|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
106154|NCT01565889|E3|Reported Event|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
106155|NCT01565889|E2|Reported Event|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
106156|NCT01565889|E1|Reported Event|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
106157|NCT01565850|B3|Baseline|Total|Total of all reporting groups
106158|NCT01565850|B2|Baseline|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106159|NCT01565850|B1|Baseline|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106160|NCT01565850|P2|Participant Flow|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106161|NCT01565850|P1|Participant Flow|D/C/F/TAF|Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
106162|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106163|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106164|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106165|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106166|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106167|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106168|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106169|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106170|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106171|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106172|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106173|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106174|NCT01565850|E2|Reported Event|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
106175|NCT01565850|E1|Reported Event|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
106176|NCT01565707|B5|Baseline|Total|Total of all reporting groups
106177|NCT01565707|B4|Baseline|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106178|NCT01565707|B3|Baseline|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106179|NCT01565707|B2|Baseline|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106180|NCT01565707|B1|Baseline|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106181|NCT01565707|P4|Participant Flow|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106182|NCT01565707|P3|Participant Flow|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106183|NCT01565707|P2|Participant Flow|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106184|NCT01565707|P1|Participant Flow|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106185|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106186|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106187|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106189|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106190|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106191|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106192|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106193|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106194|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106195|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106196|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106197|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106198|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106199|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106200|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106201|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106202|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106203|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106204|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106205|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106206|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106207|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106208|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106209|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106210|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106211|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106212|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106213|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106214|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106215|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106216|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106217|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106218|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106219|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106220|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106221|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106222|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106223|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106224|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
106225|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106226|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
106227|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
106228|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106229|NCT01565707|O1|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106230|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106231|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106232|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106233|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106234|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106235|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106236|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106237|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106238|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106239|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106240|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106241|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106242|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106243|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106244|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106245|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106246|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106247|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106248|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106249|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106250|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106251|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106252|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106253|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106254|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106255|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106256|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106257|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106258|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106259|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106260|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106261|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106262|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106263|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106264|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106265|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106266|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106267|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
106268|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
106269|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
106270|NCT01565707|E4|Reported Event|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
106271|NCT01565707|E3|Reported Event|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.
106272|NCT01565707|E2|Reported Event|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.
106273|NCT01565707|E1|Reported Event|Placebo Children|Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.
106274|NCT01565564|B3|Baseline|Total|Total of all reporting groups
106275|NCT01565564|B2|Baseline|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106276|NCT01565564|B1|Baseline|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106277|NCT01565564|P2|Participant Flow|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106278|NCT01565564|P1|Participant Flow|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106279|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106280|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106281|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106282|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106602|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106283|NCT01565564|E2|Reported Event|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106284|NCT01565564|E1|Reported Event|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
106285|NCT01565551|B3|Baseline|Total|Total of all reporting groups
106286|NCT01565551|B2|Baseline|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
106287|NCT01565551|B1|Baseline|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
106288|NCT01565551|P2|Participant Flow|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
106289|NCT01565551|P1|Participant Flow|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
106290|NCT01565551|O2|Outcome|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
106291|NCT01565551|O1|Outcome|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
106292|NCT01565551|E2|Reported Event|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
106293|NCT01565551|E1|Reported Event|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
106294|NCT01565538|B3|Baseline|Total|Total of all reporting groups
106295|NCT01565538|B2|Baseline|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106296|NCT01565538|B1|Baseline|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106297|NCT01565538|P2|Participant Flow|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106298|NCT01565538|P1|Participant Flow|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106299|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106300|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106301|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106302|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106303|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106304|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106305|NCT01565538|E2|Reported Event|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
106306|NCT01565538|E1|Reported Event|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
106307|NCT01565382|B1|Baseline|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
106308|NCT01565382|P2|Participant Flow|Physicians|Private nuclear medicine physicians with no previous training in reading florbetapir scans.
106309|NCT01565382|P1|Participant Flow|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
106310|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
106311|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
106312|NCT01565382|E1|Reported Event|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
106313|NCT01565369|B1|Baseline|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
106314|NCT01565369|P1|Participant Flow|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
106315|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
106316|NCT01565369|O1|Outcome|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
106317|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
106318|NCT01565369|E1|Reported Event|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
106319|NCT01565356|B1|Baseline|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
106320|NCT01565356|P1|Participant Flow|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
106321|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
106323|NCT01565356|E1|Reported Event|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
106324|NCT01565343|B4|Baseline|Total|Total of all reporting groups
106325|NCT01565343|B3|Baseline|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
106326|NCT01565343|B2|Baseline|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
106327|NCT01565343|B1|Baseline|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
106328|NCT01565343|P3|Participant Flow|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
106329|NCT01565343|P2|Participant Flow|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
106330|NCT01565343|P1|Participant Flow|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
106331|NCT01565343|O2|Outcome|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
106332|NCT01565343|O1|Outcome|AD Subjects|Male or female subjects > 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
106333|NCT01565343|E3|Reported Event|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
106334|NCT01565343|E2|Reported Event|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
106335|NCT01565343|E1|Reported Event|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
106336|NCT01565330|B5|Baseline|Total|Total of all reporting groups
106337|NCT01565330|B4|Baseline|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
106338|NCT01565330|B3|Baseline|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
106339|NCT01565330|B2|Baseline|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
106340|NCT01565330|B1|Baseline|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
106341|NCT01565330|P4|Participant Flow|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
106342|NCT01565330|P3|Participant Flow|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
106343|NCT01565330|P2|Participant Flow|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
106344|NCT01565330|P1|Participant Flow|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
106345|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
106346|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
106347|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
106348|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
106349|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
106350|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
106351|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
106352|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
106353|NCT01565330|E4|Reported Event|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
106354|NCT01565330|E3|Reported Event|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
106355|NCT01565330|E2|Reported Event|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
106356|NCT01565330|E1|Reported Event|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
106357|NCT01565291|B3|Baseline|Total|Total of all reporting groups
106358|NCT01565291|B2|Baseline|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
106359|NCT01565291|B1|Baseline|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
106360|NCT01565291|P2|Participant Flow|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
106361|NCT01565291|P1|Participant Flow|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
106362|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
106363|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
106364|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
106365|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
106366|NCT01565291|E2|Reported Event|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
106367|NCT01565291|E1|Reported Event|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
106368|NCT01565083|B3|Baseline|Total|Total of all reporting groups
106369|NCT01565083|B2|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106370|NCT01565083|B1|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106371|NCT01565083|P2|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106372|NCT01565083|P1|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106373|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106374|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106375|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106376|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106428|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106433|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106377|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106378|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106379|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106380|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106381|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106382|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106383|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106384|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106385|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106429|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106430|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106386|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106387|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106388|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106389|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106390|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106391|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106392|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106393|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106394|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106431|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106432|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106395|NCT01565083|E2|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106396|NCT01565083|E1|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
106397|NCT01564862|B4|Baseline|Total|Total of all reporting groups
106398|NCT01564862|B3|Baseline|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106399|NCT01564862|B2|Baseline|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106400|NCT01564862|B1|Baseline|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106401|NCT01564862|P3|Participant Flow|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106402|NCT01564862|P2|Participant Flow|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106403|NCT01564862|P1|Participant Flow|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106404|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106405|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106406|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106407|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106408|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106409|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106410|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106411|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106412|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106413|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106414|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106415|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106416|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106417|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106418|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106419|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106420|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106421|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106422|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106423|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106424|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106425|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106426|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106427|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106434|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106435|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106436|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106437|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106438|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106439|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106440|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106441|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106442|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106443|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106444|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106445|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106446|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106447|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106448|NCT01564862|E3|Reported Event|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
106449|NCT01564862|E2|Reported Event|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
106450|NCT01564862|E1|Reported Event|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
106451|NCT01564758|B1|Baseline|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
106452|NCT01564758|P1|Participant Flow|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
106453|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
106454|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
106455|NCT01564758|E1|Reported Event|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
106456|NCT01564732|B3|Baseline|Total|Total of all reporting groups
106457|NCT01564732|B2|Baseline|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106458|NCT01564732|B1|Baseline|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106459|NCT01564732|P2|Participant Flow|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106490|NCT01564693|E2|Reported Event|NON-ANOREXIC CANCER PATIENTS|Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
106460|NCT01564732|P1|Participant Flow|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106461|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106462|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106463|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106464|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106465|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106466|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106467|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106468|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106491|NCT01564693|E1|Reported Event|ANOREXIC CANCER PATIENTS|Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
106492|NCT01563406|B5|Baseline|Total|Total of all reporting groups
106493|NCT01563406|B4|Baseline|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
106469|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106470|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106471|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106472|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106473|NCT01564732|E2|Reported Event|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
106474|NCT01564732|E1|Reported Event|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
106475|NCT01564706|B1|Baseline|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
106476|NCT01564706|P1|Participant Flow|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
106477|NCT01564706|O1|Outcome|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
106478|NCT01564706|E1|Reported Event|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
106479|NCT01564693|B4|Baseline|Total|Total of all reporting groups
106480|NCT01564693|B3|Baseline|CONTROL GROUP|These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
106481|NCT01564693|B2|Baseline|NON-ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as non-anorexic
106482|NCT01564693|B1|Baseline|ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as anorexic.
106483|NCT01564693|P3|Participant Flow|CONTROL GROUP|Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
106484|NCT01564693|P2|Participant Flow|NON-ANOREXIC CANCER PATIENTS|According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.
106485|NCT01564693|P1|Participant Flow|ANOREXIC CANCER PATIENTS|We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.
106486|NCT01564693|O3|Outcome|CONTROL GROUP|Healthy subjects were studied regarding BOLD signal activity by fMRI
106487|NCT01564693|O2|Outcome|NON-ANOREXIC CANCER PATIENTS|Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
106488|NCT01564693|O1|Outcome|ANOREXIC CANCER PATIENTS|Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
106489|NCT01564693|E3|Reported Event|CONTROL GROUP|Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
106494|NCT01563406|B3|Baseline|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106495|NCT01563406|B2|Baseline|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
106496|NCT01563406|B1|Baseline|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
106497|NCT01563406|P4|Participant Flow|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
106498|NCT01563406|P3|Participant Flow|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106499|NCT01563406|P2|Participant Flow|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
106500|NCT01563406|P1|Participant Flow|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
106501|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
106502|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106503|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
106504|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
106505|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
106506|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106507|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
106508|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
106509|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
106510|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106511|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
106512|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
106513|NCT01563406|E4|Reported Event|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
106514|NCT01563406|E3|Reported Event|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
106515|NCT01563406|E2|Reported Event|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
106516|NCT01563406|E1|Reported Event|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
106517|NCT01564537|B3|Baseline|Total|Total of all reporting groups
106518|NCT01564537|B2|Baseline|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106519|NCT01564537|B1|Baseline|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106520|NCT01564537|P2|Participant Flow|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106521|NCT01564537|P1|Participant Flow|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
106522|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106523|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106545|NCT01564459|P2|Participant Flow|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
106524|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106525|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106526|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106527|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106528|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106529|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106530|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106531|NCT01564537|O1|Outcome|Ixazomib + Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106532|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106533|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106534|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106535|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106536|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106537|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106538|NCT01564537|E2|Reported Event|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
106539|NCT01564537|E1|Reported Event|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity up to EOT projected at 80 months.
106540|NCT01564459|B4|Baseline|Total|Total of all reporting groups
106541|NCT01564459|B3|Baseline|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
106542|NCT01564459|B2|Baseline|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
106543|NCT01564459|B1|Baseline|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
106544|NCT01564459|P3|Participant Flow|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
106546|NCT01564459|P1|Participant Flow|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
106547|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
106548|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
106549|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
106550|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
106551|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
106552|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
106553|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
106554|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
106555|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
106556|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
106557|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
106558|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
106559|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
106560|NCT01564459|O1|Outcome|MK-6096|Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
106561|NCT01564459|E3|Reported Event|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
106562|NCT01564459|E2|Reported Event|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
106563|NCT01564459|E1|Reported Event|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
106564|NCT01564394|B3|Baseline|Total|Total of all reporting groups
106565|NCT01564394|B2|Baseline|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106566|NCT01564394|B1|Baseline|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106567|NCT01564394|P2|Participant Flow|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106568|NCT01564394|P1|Participant Flow|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106569|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106570|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106596|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106597|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106598|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106599|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106600|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106571|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106572|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106573|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106574|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106575|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106576|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106577|NCT01564394|E2|Reported Event|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
106578|NCT01564394|E1|Reported Event|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
106579|NCT01563978|B3|Baseline|Total|Total of all reporting groups
106580|NCT01563978|B2|Baseline|PLACEBO|Oral treatment
106581|NCT01563978|B1|Baseline|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106582|NCT01563978|P2|Participant Flow|PLACEBO|Oral treatment
106583|NCT01563978|P1|Participant Flow|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106584|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106585|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106586|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106587|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106588|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106589|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106590|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106591|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106592|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106593|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106594|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
106595|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106603|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
106604|NCT01563978|E2|Reported Event|PLACEBO|
106605|NCT01563978|E1|Reported Event|FOSTA 100 MG BID|
106606|NCT01563536|B3|Baseline|Total|Total of all reporting groups
106607|NCT01563536|B2|Baseline|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106608|NCT01563536|B1|Baseline|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106609|NCT01563536|P2|Participant Flow|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106610|NCT01563536|P1|Participant Flow|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106611|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106612|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106613|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106614|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106615|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106616|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106617|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106618|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106619|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106620|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106621|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106622|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106623|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106624|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106625|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106626|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106627|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106628|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106629|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106630|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106631|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106632|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106633|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106634|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106635|NCT01563536|E2|Reported Event|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106636|NCT01563536|E1|Reported Event|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
106637|NCT01563185|B1|Baseline|DUEXIS|"800 mg ibuprofen/26.6 mg famotidine~800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day"
106638|NCT01563185|P1|Participant Flow|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106639|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106640|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106641|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106642|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106643|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106644|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106645|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106646|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106647|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106648|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106649|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106650|NCT01563185|E1|Reported Event|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
106651|NCT01563081|B3|Baseline|Total|Total of all reporting groups
106652|NCT01563081|B2|Baseline|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
106653|NCT01563081|B1|Baseline|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
106654|NCT01563081|P2|Participant Flow|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
106655|NCT01563081|P1|Participant Flow|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
106656|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
106657|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
106830|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106658|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
106659|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
106660|NCT01563081|O1|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
106661|NCT01563081|O3|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
106662|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
106663|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
106664|NCT01563081|E3|Reported Event|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
106665|NCT01563081|E2|Reported Event|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
106666|NCT01563081|E1|Reported Event|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
106667|NCT01563055|B1|Baseline|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106668|NCT01563055|P1|Participant Flow|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106669|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106670|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106732|NCT01563029|P4|Participant Flow|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106829|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106671|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106672|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106673|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106674|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106675|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106676|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106677|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106733|NCT01563029|P3|Participant Flow|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106678|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106679|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106680|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106681|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106682|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106683|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106684|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106734|NCT01563029|P2|Participant Flow|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106685|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106686|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106687|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106688|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106689|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106690|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106691|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106735|NCT01563029|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106692|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106693|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106694|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106695|NCT01563055|O1|Outcome|Overall Study Arm|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106696|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106697|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106698|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106736|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106699|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106700|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106701|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106702|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106703|NCT01563055|O1|Outcome|Ofatumumab +Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106704|NCT01563055|O1|Outcome|Overall Study Arm|ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106705|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106737|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106916|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106706|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106707|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106708|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106709|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106710|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106711|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106712|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106738|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106713|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106714|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106715|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106716|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106717|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106718|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106719|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106739|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106720|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106721|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106722|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106723|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
106724|NCT01563055|E1|Reported Event|Ofatumumab+Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
106725|NCT01563029|B6|Baseline|Total|Total of all reporting groups
106726|NCT01563029|B5|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106727|NCT01563029|B4|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106728|NCT01563029|B3|Baseline|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106729|NCT01563029|B2|Baseline|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106730|NCT01563029|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106731|NCT01563029|P5|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106740|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106741|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106742|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106743|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106744|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106745|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106746|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106747|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106748|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106749|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106750|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106751|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106752|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106753|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106754|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106755|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106756|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106757|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106758|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106917|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106759|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106760|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106761|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106762|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106763|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106764|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106765|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106766|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106767|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106768|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106769|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106770|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106771|NCT01563029|O6|Outcome|Average of FF 50 µg OD and FF 100 µg OD|All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106772|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106773|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106774|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106775|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106776|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106828|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106918|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106777|NCT01563029|E5|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106778|NCT01563029|E4|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106779|NCT01563029|E3|Reported Event|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106780|NCT01563029|E2|Reported Event|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106781|NCT01563029|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
106782|NCT01563003|B3|Baseline|Total|Total of all reporting groups
106783|NCT01563003|B2|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106784|NCT01563003|B1|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106785|NCT01563003|P2|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106786|NCT01563003|P1|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106787|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106788|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106789|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106790|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106791|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106792|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106793|NCT01563003|E2|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
106794|NCT01563003|E1|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
106795|NCT01562886|B1|Baseline|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
106796|NCT01562886|P1|Participant Flow|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
106797|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
106798|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
106799|NCT01562886|E1|Reported Event|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 26mg"
106800|NCT01562743|B1|Baseline|SPM 962|Rotigotine transdermal patch
106801|NCT01562743|P1|Participant Flow|SPM 962|"Rotigotine transdermal patch~A patch containing 2.25 - 6.75mg of rotigotine was administered once a day."
106802|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106803|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106804|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106805|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106806|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106807|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106808|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
106809|NCT01562743|E1|Reported Event|SPM 962|Rotigotine transdermal patch
106810|NCT01562613|B1|Baseline|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106811|NCT01562613|P1|Participant Flow|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106812|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106813|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106814|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106815|NCT01562613|E1|Reported Event|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
106816|NCT01562548|B5|Baseline|Total|Total of all reporting groups
106817|NCT01562548|B4|Baseline|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106818|NCT01562548|B3|Baseline|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106819|NCT01562548|B2|Baseline|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106820|NCT01562548|B1|Baseline|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106821|NCT01562548|P4|Participant Flow|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106822|NCT01562548|P3|Participant Flow|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106823|NCT01562548|P2|Participant Flow|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106824|NCT01562548|P1|Participant Flow|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106825|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106826|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106827|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106831|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106832|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106833|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106834|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106835|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106836|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106837|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106838|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106839|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106840|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106841|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106842|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106843|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106844|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106845|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106846|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106847|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106848|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106849|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106850|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106851|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106852|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106853|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106854|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106855|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106856|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106857|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106858|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106859|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106860|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106861|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106862|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106863|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106864|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106865|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
106866|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106867|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days
106868|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106869|NCT01562548|E4|Reported Event|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106870|NCT01562548|E3|Reported Event|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
106871|NCT01562548|E2|Reported Event|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
106872|NCT01562548|E1|Reported Event|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
106873|NCT01562327|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
106874|NCT01562327|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
106875|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106876|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106877|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106878|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106879|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106880|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106881|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106882|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106883|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106884|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106885|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106886|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106887|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106888|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106889|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
106890|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
106891|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
106892|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106893|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106894|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106895|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106896|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106897|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106898|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106899|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106900|NCT01562327|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
106901|NCT01562314|B3|Baseline|Total|Total of all reporting groups
106902|NCT01562314|B2|Baseline|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106903|NCT01562314|B1|Baseline|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106904|NCT01562314|P2|Participant Flow|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106905|NCT01562314|P1|Participant Flow|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106906|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
106907|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
106908|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106909|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106910|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
106911|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
106912|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106913|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106914|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106915|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106919|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106920|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106921|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106922|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106923|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106924|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106925|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106926|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106927|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106928|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106929|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106930|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
106931|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
106932|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106933|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106934|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106935|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106936|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106937|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106938|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106939|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106940|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106941|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106942|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106943|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106944|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106945|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106946|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106947|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106948|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106949|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106950|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106951|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106952|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106953|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106954|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106955|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106956|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106957|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106958|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106959|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106960|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106961|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106962|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106963|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106964|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106965|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106966|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106967|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106968|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106969|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106970|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106971|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106972|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106973|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106974|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106975|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106976|NCT01562314|E2|Reported Event|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
106977|NCT01562314|E1|Reported Event|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
106978|NCT01562275|B14|Baseline|Total|Total of all reporting groups
106979|NCT01562275|B13|Baseline|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106980|NCT01562275|B12|Baseline|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106981|NCT01562275|B11|Baseline|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106982|NCT01562275|B10|Baseline|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106983|NCT01562275|B9|Baseline|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106984|NCT01562275|B8|Baseline|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106985|NCT01562275|B7|Baseline|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106986|NCT01562275|B6|Baseline|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106987|NCT01562275|B5|Baseline|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106988|NCT01562275|B4|Baseline|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106989|NCT01562275|B3|Baseline|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106990|NCT01562275|B2|Baseline|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106991|NCT01562275|B1|Baseline|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106992|NCT01562275|P13|Participant Flow|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106993|NCT01562275|P12|Participant Flow|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106994|NCT01562275|P11|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106995|NCT01562275|P10|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107187|NCT01561703|B2|Baseline|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
106996|NCT01562275|P9|Participant Flow|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106997|NCT01562275|P8|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106998|NCT01562275|P7|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
106999|NCT01562275|P6|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107000|NCT01562275|P5|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107001|NCT01562275|P4|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107002|NCT01562275|P3|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107003|NCT01562275|P2|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107004|NCT01562275|P1|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 milligrams (mg) cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107005|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107006|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107007|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107008|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107009|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107010|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107011|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107012|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107013|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107014|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107015|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107016|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107017|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107018|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107019|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107020|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107021|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107022|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107023|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107024|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107025|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107026|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107027|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107028|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107029|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107030|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107031|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107144|NCT01561898|B3|Baseline|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107032|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107033|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107034|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107035|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107036|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107037|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107038|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107039|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107040|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107041|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107042|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107043|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107044|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107045|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107046|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107047|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107048|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107049|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107344|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107050|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107051|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107052|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107053|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107054|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107055|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107056|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107057|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107058|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107059|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107060|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107061|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107062|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107063|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107064|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107065|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107066|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107067|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107235|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107068|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107069|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107070|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107071|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107072|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107073|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107074|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107075|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107076|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107077|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107078|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107079|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107080|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107081|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107082|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107083|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107084|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107085|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107236|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107086|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107087|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107088|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107089|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107090|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107091|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107092|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107093|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107094|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107095|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107096|NCT01562275|O1|Outcome|DECs and Expansion Cohorts|Included all participants who were treated under Stage 1 (Dose Escalation Cohorts) and Stage 2 (Dose Expansion Cohorts).
107097|NCT01562275|O1|Outcome|Stage 1 DECs|During Stage 1, participants received cobimetinib and ipatasertib combination doses either under Arm A (21/7 dosing schedule [cobimetinib and ipatasertib taken concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days]) or under Arm B (intermittent cobimetinib dosing schedule [ipatasertib taken once daily on Days 1-21 consecutively with concurrent dosing of cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days)] until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107098|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107099|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107100|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107101|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107102|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107103|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107237|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107104|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107105|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107106|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107107|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107108|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107109|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107110|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107111|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107112|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107113|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107114|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107115|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107116|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107117|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107118|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107119|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107120|NCT01562275|E13|Reported Event|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107121|NCT01562275|E12|Reported Event|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107145|NCT01561898|B2|Baseline|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107122|NCT01562275|E11|Reported Event|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107123|NCT01562275|E10|Reported Event|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107124|NCT01562275|E9|Reported Event|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107125|NCT01562275|E8|Reported Event|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107126|NCT01562275|E7|Reported Event|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107127|NCT01562275|E6|Reported Event|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107128|NCT01562275|E5|Reported Event|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107129|NCT01562275|E4|Reported Event|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107130|NCT01562275|E3|Reported Event|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107131|NCT01562275|E2|Reported Event|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107132|NCT01562275|E1|Reported Event|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
107133|NCT01562132|B3|Baseline|Total|Total of all reporting groups
107134|NCT01562132|B2|Baseline|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107135|NCT01562132|B1|Baseline|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107136|NCT01562132|P2|Participant Flow|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107137|NCT01562132|P1|Participant Flow|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107138|NCT01562132|O2|Outcome|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107139|NCT01562132|O1|Outcome|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107140|NCT01562132|E2|Reported Event|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107141|NCT01562132|E1|Reported Event|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
107142|NCT01561898|B5|Baseline|Total|Total of all reporting groups
107143|NCT01561898|B4|Baseline|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107186|NCT01561703|B3|Baseline|Total|Total of all reporting groups
107146|NCT01561898|B1|Baseline|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107147|NCT01561898|P4|Participant Flow|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107148|NCT01561898|P3|Participant Flow|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107149|NCT01561898|P2|Participant Flow|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107150|NCT01561898|P1|Participant Flow|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107151|NCT01561898|O1|Outcome|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107152|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107153|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107154|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107155|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107156|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107157|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107158|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107159|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107160|NCT01561898|E1|Reported Event|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
107161|NCT01561716|B7|Baseline|Total|Total of all reporting groups
107162|NCT01561716|B6|Baseline|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
107163|NCT01561716|B5|Baseline|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
107164|NCT01561716|B4|Baseline|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
107165|NCT01561716|B3|Baseline|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
107166|NCT01561716|B2|Baseline|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
107167|NCT01561716|B1|Baseline|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
107168|NCT01561716|P6|Participant Flow|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
107169|NCT01561716|P5|Participant Flow|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
107170|NCT01561716|P4|Participant Flow|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
107171|NCT01561716|P3|Participant Flow|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
107172|NCT01561716|P2|Participant Flow|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
107173|NCT01561716|P1|Participant Flow|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
107174|NCT01561716|O6|Outcome|Treadmill Running/Walking|Energy expenditure during 30 min treadmill running/walking
107175|NCT01561716|O5|Outcome|Wii Fit Rhythm Boxing|Energy expenditure during 10 min Wii Fit Rhythm Boxing
107176|NCT01561716|O4|Outcome|Wii Fit Advanced Steps|Energy expenditure during 10 min Wii Fit Advanced Steps
107177|NCT01561716|O3|Outcome|Wii Fit Super Hula Hoop|Energy expenditure during 10 min Wii Fit Super Hula Hoop
107178|NCT01561716|O2|Outcome|Wii Fit Free Run|Energy expenditure during 30 min Wii Fit Free Run
107179|NCT01561716|O1|Outcome|At Rest|Energy expenditure at rest
107180|NCT01561716|E6|Reported Event|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
107181|NCT01561716|E5|Reported Event|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
107182|NCT01561716|E4|Reported Event|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
107183|NCT01561716|E3|Reported Event|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
107184|NCT01561716|E2|Reported Event|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
107185|NCT01561716|E1|Reported Event|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
107188|NCT01561703|B1|Baseline|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
107189|NCT01561703|P2|Participant Flow|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
107190|NCT01561703|P1|Participant Flow|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
107191|NCT01561703|O2|Outcome|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
107192|NCT01561703|O1|Outcome|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
107193|NCT01561703|E2|Reported Event|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
107194|NCT01561703|E1|Reported Event|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
107195|NCT01561560|B1|Baseline|OVERALL|Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
107196|NCT01561560|P2|Participant Flow|TRUEYE, Then DAILIES TOTAL1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
107197|NCT01561560|P1|Participant Flow|DAILIES TOTAL1, Then TRUEYE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
107198|NCT01561560|O2|Outcome|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
107199|NCT01561560|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
107200|NCT01561560|E2|Reported Event|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
107201|NCT01561560|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
107202|NCT01561469|B3|Baseline|Total|Total of all reporting groups
107203|NCT01561469|B2|Baseline|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107204|NCT01561469|B1|Baseline|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107205|NCT01561469|P2|Participant Flow|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107206|NCT01561469|P1|Participant Flow|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107207|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107208|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107209|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107210|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107211|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107212|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107213|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107214|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107215|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107216|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107217|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107218|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107219|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107220|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107221|NCT01561469|E2|Reported Event|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107222|NCT01561469|E1|Reported Event|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
107223|NCT01561313|B3|Baseline|Total|Total of all reporting groups
107224|NCT01561313|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
107225|NCT01561313|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
107226|NCT01561313|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
107227|NCT01561313|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
107228|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107229|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107230|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107231|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107232|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107233|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107234|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107238|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107239|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107240|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107241|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107242|NCT01561313|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
107243|NCT01561313|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
107244|NCT01560975|B1|Baseline|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
107245|NCT01560975|P1|Participant Flow|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
107246|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
107247|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
107248|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
107249|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
107250|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
107251|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
107252|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
107253|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
107254|NCT01560975|O2|Outcome|noPOAG/CPAP|Subjects with CPAP
107255|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
107256|NCT01560975|E1|Reported Event|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
107257|NCT01560819|B3|Baseline|Total|Total of all reporting groups
107258|NCT01560819|B2|Baseline|Donors|Healthy donors (>18 years of age) were chosen by participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
107259|NCT01560819|B1|Baseline|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
107260|NCT01560819|P2|Participant Flow|Donors|Healthy donors (>18 years of age) were chosen by the participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
107261|NCT01560819|P1|Participant Flow|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
107262|NCT01560819|O1|Outcome|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate ulcerative colitis (UC) (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
107263|NCT01560819|E1|Reported Event|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
107264|NCT01560507|B4|Baseline|Total|Total of all reporting groups
107265|NCT01560507|B3|Baseline|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
107266|NCT01560507|B2|Baseline|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
107267|NCT01560507|B1|Baseline|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
107268|NCT01560507|P3|Participant Flow|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
107269|NCT01560507|P2|Participant Flow|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
107270|NCT01560507|P1|Participant Flow|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
107289|NCT01560429|E2|Reported Event|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
108245|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
107271|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.~bupropion (Zyban) & nicotine patches: After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
107272|NCT01560507|O2|Outcome|Nicotine Patches|"This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.~nicotine patches: 21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks."
107273|NCT01560507|O1|Outcome|Varenicline (Chantix)|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.~varenicline (Chantix): For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
107274|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
107275|NCT01560507|O2|Outcome|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
107276|NCT01560507|O1|Outcome|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
107277|NCT01560507|E3|Reported Event|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
107278|NCT01560507|E2|Reported Event|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
107279|NCT01560507|E1|Reported Event|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
107280|NCT01560429|B3|Baseline|Total|Total of all reporting groups
107281|NCT01560429|B2|Baseline|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
107282|NCT01560429|B1|Baseline|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
107283|NCT01560429|P2|Participant Flow|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
107284|NCT01560429|P1|Participant Flow|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
107285|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
107286|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
107287|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
107288|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
107338|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107339|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107340|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107341|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107290|NCT01560429|E1|Reported Event|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
107291|NCT01560403|B3|Baseline|Total|Total of all reporting groups
107292|NCT01560403|B2|Baseline|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
107293|NCT01560403|B1|Baseline|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
107294|NCT01560403|P2|Participant Flow|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
107295|NCT01560403|P1|Participant Flow|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
107296|NCT01560403|O2|Outcome|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
107297|NCT01560403|O1|Outcome|NT,PBO/TED|This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.
107298|NCT01560403|E2|Reported Event|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
107299|NCT01560403|E1|Reported Event|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
107300|NCT01560260|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
107301|NCT01560260|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
107302|NCT01560260|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
107303|NCT01560260|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
107304|NCT01560234|B9|Baseline|Total|Total of all reporting groups
107305|NCT01560234|B8|Baseline|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107306|NCT01560234|B7|Baseline|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107307|NCT01560234|B6|Baseline|Cohort 5|AZD8848 15 μg
107308|NCT01560234|B5|Baseline|Cohort 4|AZD8848 5 μg
107309|NCT01560234|B4|Baseline|Cohort 3|AZD8848 1.5 μg
107310|NCT01560234|B3|Baseline|Cohort 2|AZD8848 0.5 ug
107311|NCT01560234|B2|Baseline|Cohort 1|AZD8848 0.15 μg
107312|NCT01560234|B1|Baseline|Placebo|Commercial 0.9% sodium chloride solution.
107313|NCT01560234|P8|Participant Flow|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107314|NCT01560234|P7|Participant Flow|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107315|NCT01560234|P6|Participant Flow|Cohort 5|AZD8848 15 μg
107316|NCT01560234|P5|Participant Flow|Cohort 4|AZD8848 5 μg
107317|NCT01560234|P4|Participant Flow|Cohort 3|AZD8848 1.5 μg
107318|NCT01560234|P3|Participant Flow|Cohort 2|AZD8848 0.5 ug
107319|NCT01560234|P2|Participant Flow|Cohort 1|AZD8848 0.15 μg
107320|NCT01560234|P1|Participant Flow|Placebo|Commercial 0.9% sodium chloride solution.
107321|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107322|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107323|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107324|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107325|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107326|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107327|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107328|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107329|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107330|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107331|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107332|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107333|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107334|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107335|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107336|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107337|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107345|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107346|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107347|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107348|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107349|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107350|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107351|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107352|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107353|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107354|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107355|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107356|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107357|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107358|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107359|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107360|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107361|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107362|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107363|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107364|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107365|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107366|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107367|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107368|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107369|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107370|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107371|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107372|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107373|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107374|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107375|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107376|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107377|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107378|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107379|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
107380|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
107381|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
107382|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
107383|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
107384|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
107385|NCT01560234|E8|Reported Event|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
107386|NCT01560234|E7|Reported Event|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
107387|NCT01560234|E6|Reported Event|Cohort 5|AZD8848 15 μg
107388|NCT01560234|E5|Reported Event|Cohort 4|AZD8848 5 μg
107389|NCT01560234|E4|Reported Event|Cohort 3|AZD8848 1.5 μg
107390|NCT01560234|E3|Reported Event|Cohort 2|AZD8848 0.5 ug
107391|NCT01560234|E2|Reported Event|Cohort 1|AZD8848 0.15 μg
107392|NCT01560234|E1|Reported Event|Placebo|Commercial 0.9% sodium chloride solution.
107393|NCT01560143|B1|Baseline|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
107394|NCT01560143|P1|Participant Flow|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
107395|NCT01560143|O1|Outcome|Serum AUC of Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
107396|NCT01560143|E1|Reported Event|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
107397|NCT01559922|B3|Baseline|Total|Total of all reporting groups
107398|NCT01559922|B2|Baseline|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
107399|NCT01559922|B1|Baseline|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
107400|NCT01559922|P2|Participant Flow|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
107401|NCT01559922|P1|Participant Flow|Placebo|Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
107402|NCT01559922|O2|Outcome|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
107403|NCT01559922|O1|Outcome|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
107404|NCT01559922|E2|Reported Event|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
107405|NCT01559922|E1|Reported Event|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
107406|NCT01559844|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107407|NCT01559844|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107408|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107409|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107410|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
108246|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
107411|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107412|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107413|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107414|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107415|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107416|NCT01559844|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
107417|NCT01559675|B3|Baseline|Total|Total of all reporting groups
107418|NCT01559675|B2|Baseline|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
107419|NCT01559675|B1|Baseline|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
107420|NCT01559675|P2|Participant Flow|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
107421|NCT01559675|P1|Participant Flow|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
107422|NCT01559675|O2|Outcome|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
107423|NCT01559675|O1|Outcome|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
107424|NCT01559675|E2|Reported Event|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
107467|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107468|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107469|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107425|NCT01559675|E1|Reported Event|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
107426|NCT01559649|B3|Baseline|Total|Total of all reporting groups
107427|NCT01559649|B2|Baseline|Nurses|Registered nurses working on MEDVAMC stroke wards
107428|NCT01559649|B1|Baseline|Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
107429|NCT01559649|P2|Participant Flow|Registered Nurses|Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
107430|NCT01559649|P1|Participant Flow|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
107431|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
107432|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
107433|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses
107434|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
107435|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
107436|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
107437|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
107438|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
107439|NCT01559649|E1|Reported Event|Patients With Suspected Stroke|Individuals admitted with suspected ischemic or hemorrhagic stroke
107440|NCT01559506|B3|Baseline|Total|Total of all reporting groups
107441|NCT01559506|B2|Baseline|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
107442|NCT01559506|B1|Baseline|No Device|Subject does not receive ABS system
107443|NCT01559506|P2|Participant Flow|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
107444|NCT01559506|P1|Participant Flow|No Device|Subject does not receive ABS system
107445|NCT01559506|O2|Outcome|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
107446|NCT01559506|O1|Outcome|No Device|Subject does not receive ABS system
107447|NCT01559506|E2|Reported Event|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
107448|NCT01559506|E1|Reported Event|No Device|Subject does not receive ABS system
107449|NCT01559311|B4|Baseline|Total|Total of all reporting groups
107450|NCT01559311|B3|Baseline|DDDR|Control Group – DDDR Standard Therapy
107451|NCT01559311|B2|Baseline|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
107452|NCT01559311|B1|Baseline|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
107453|NCT01559311|P3|Participant Flow|DDDR|Control Group – DDDR Standard Therapy
107454|NCT01559311|P2|Participant Flow|CRT-P ON|Echo-guided Group – Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
107455|NCT01559311|P1|Participant Flow|CRT-P OFF|Echo-guided Group – Dual chamber pacemaker (DDDR) Standard Therapy
107456|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
107457|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
107458|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
107459|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
107460|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
107461|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
107462|NCT01559311|E3|Reported Event|DDDR|Control Group – DDDR Standard Therapy
107463|NCT01559311|E2|Reported Event|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
107464|NCT01559311|E1|Reported Event|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
107465|NCT01559116|B1|Baseline|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
107466|NCT01559116|P1|Participant Flow|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
107470|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107471|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107472|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107473|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107474|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107475|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107476|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107477|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107478|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107479|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107480|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107481|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107482|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107483|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107484|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107485|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107486|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107487|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107488|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107489|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107490|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107491|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107492|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107493|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107494|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107495|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107496|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107497|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107498|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107499|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107500|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107501|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107502|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107503|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107504|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107505|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107506|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107507|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107508|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.)
107509|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107510|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107511|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107512|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107513|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107514|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107515|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107516|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107517|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107518|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107519|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107520|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107521|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107522|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107523|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107524|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107525|NCT01559116|O2|Outcome|Olodaterol (5 µg)|"Olodaterol solution for inhalation - RESPIMAT~2 oral inhalations once daily in the morning for 6 weeks."
107526|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT:2 Oral inhalations once daily in the morning for 6 weeks.
107527|NCT01559116|E6|Reported Event|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107528|NCT01559116|E5|Reported Event|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107529|NCT01559116|E4|Reported Event|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107530|NCT01559116|E3|Reported Event|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
107531|NCT01559116|E2|Reported Event|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
107532|NCT01559116|E1|Reported Event|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
107533|NCT01559064|B4|Baseline|Total|Total of all reporting groups
107534|NCT01559064|B3|Baseline|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107535|NCT01559064|B2|Baseline|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107536|NCT01559064|B1|Baseline|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107537|NCT01559064|P3|Participant Flow|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107538|NCT01559064|P2|Participant Flow|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107539|NCT01559064|P1|Participant Flow|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107540|NCT01559064|O3|Outcome|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107541|NCT01559064|O2|Outcome|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107542|NCT01559064|O1|Outcome|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107543|NCT01559064|E3|Reported Event|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107544|NCT01559064|E2|Reported Event|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107545|NCT01559064|E1|Reported Event|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
107546|NCT01559012|B3|Baseline|Total|Total of all reporting groups
107547|NCT01559012|B2|Baseline|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107548|NCT01559012|B1|Baseline|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107549|NCT01559012|P2|Participant Flow|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107550|NCT01559012|P1|Participant Flow|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107551|NCT01559012|O2|Outcome|Placebo|diastolic blood pressure was recorded every day during placebo cycle
107552|NCT01559012|O1|Outcome|Clonidine|diastolic blood pressure was recorded every day during clonidine treatment cycle
107553|NCT01559012|O2|Outcome|Placebo|systolic blood pressure was recorded during placebo cycle
107554|NCT01559012|O1|Outcome|Clonidine|systolic blood pressure was recorded during clonidine treatment cycle
107555|NCT01559012|O2|Outcome|APGAR Score at 5'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107556|NCT01559012|O1|Outcome|APGAR Score at 1'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107557|NCT01559012|O1|Outcome|Mean Birth Weight of 12 Patients|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
107558|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107559|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107560|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107561|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.
107562|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107563|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
107564|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
107565|NCT01559012|O1|Outcome|Clonidine|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
107566|NCT01559012|O2|Outcome|Placebo|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107567|NCT01559012|O1|Outcome|Clonidine|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
107568|NCT01559012|O2|Outcome|Placebo|"Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized~Every patient is the comparison as to herself"
107569|NCT01559012|O1|Outcome|Clonidine|"Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized.~Every patient is the comparison as to herself"
107570|NCT01559012|E2|Reported Event|Placebo|patients are treated with placebo (sham patch) for 5 days
107571|NCT01559012|E1|Reported Event|Clonidine|patients are treated with transdermal clonidine patch 5 mg for 5 days
107572|NCT01558791|B3|Baseline|Total|Total of all reporting groups
107573|NCT01558791|B2|Baseline|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107574|NCT01558791|B1|Baseline|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107575|NCT01558791|P2|Participant Flow|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107576|NCT01558791|P1|Participant Flow|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107577|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107578|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107579|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107580|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107581|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107582|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107583|NCT01558791|E2|Reported Event|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
107584|NCT01558791|E1|Reported Event|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
107585|NCT01558739|B1|Baseline|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107586|NCT01558739|P1|Participant Flow|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107587|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107588|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107589|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107590|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107591|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107592|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107593|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107594|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107595|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107596|NCT01558739|E1|Reported Event|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
107597|NCT01558700|B3|Baseline|Total|Total of all reporting groups
107598|NCT01558700|B2|Baseline|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
107599|NCT01558700|B1|Baseline|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
107600|NCT01558700|P2|Participant Flow|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
107601|NCT01558700|P1|Participant Flow|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
107602|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
107603|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
107604|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
107605|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
107606|NCT01558700|E2|Reported Event|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
107607|NCT01558700|E1|Reported Event|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
107608|NCT01558596|B3|Baseline|Total|Total of all reporting groups
107643|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107644|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107609|NCT01558596|B2|Baseline|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
107610|NCT01558596|B1|Baseline|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
107611|NCT01558596|P2|Participant Flow|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
107612|NCT01558596|P1|Participant Flow|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
107613|NCT01558596|O2|Outcome|RIPC|
107614|NCT01558596|O1|Outcome|Sham|
107615|NCT01558596|E2|Reported Event|RIPC|Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3)
107616|NCT01558596|E1|Reported Event|Sham|Blood pressure cuff inflated to 40 mmHg to mask controls
107617|NCT01558297|B4|Baseline|Total|Total of all reporting groups
107618|NCT01558297|B3|Baseline|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107619|NCT01558297|B2|Baseline|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107620|NCT01558297|B1|Baseline|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107621|NCT01558297|P3|Participant Flow|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107622|NCT01558297|P2|Participant Flow|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107623|NCT01558297|P1|Participant Flow|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107624|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107625|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107626|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107627|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107628|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107629|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107630|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107631|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107632|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107633|NCT01558297|E3|Reported Event|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
107634|NCT01558297|E2|Reported Event|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
107635|NCT01558297|E1|Reported Event|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
107636|NCT01558271|B4|Baseline|Total|Total of all reporting groups
107637|NCT01558271|B3|Baseline|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107638|NCT01558271|B2|Baseline|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107639|NCT01558271|B1|Baseline|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107640|NCT01558271|P3|Participant Flow|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107641|NCT01558271|P2|Participant Flow|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107642|NCT01558271|P1|Participant Flow|LY2189265|Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107706|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107645|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107646|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107647|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107648|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107649|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107650|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107651|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107652|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107653|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107654|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107655|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107656|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107657|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107658|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107659|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107660|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107661|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107662|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107663|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107664|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107665|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107666|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107667|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107668|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107669|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107670|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107671|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107672|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107673|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107674|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107675|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107676|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107677|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107678|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107679|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107680|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107681|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107682|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107683|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107684|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107685|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107686|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107687|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107688|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107689|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107690|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107691|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107692|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107693|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107694|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107695|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107696|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107697|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 24 weeks of open therapy.
107698|NCT01558271|O2|Outcome|Placebo|Once-weekly SC injection of placebo for 26 weeks of blinded therapy.
107699|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy.
107700|NCT01558271|E3|Reported Event|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
107701|NCT01558271|E2|Reported Event|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107702|NCT01558271|E1|Reported Event|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
107703|NCT01558089|B1|Baseline|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
107704|NCT01558089|P1|Participant Flow|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
107705|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107707|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107708|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107709|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107710|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107711|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107712|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
107713|NCT01558089|E1|Reported Event|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
107714|NCT01557959|B1|Baseline|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
107715|NCT01557959|P1|Participant Flow|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
107716|NCT01557959|O1|Outcome|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
107717|NCT01557959|E1|Reported Event|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
107718|NCT01557920|B1|Baseline|Crossover Randomized Propofol and Sevoflurane|"The healthy subject will be anesthetized with Propofol and Sevoflurane in a randomized crossover fashion. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Spontaneous swallows were identified, and categorized as physiological or pathological. Physiological swallows were followed by expiratory flow (E or I–E). Pathological swallows were followed by inspiration (I and E–I).~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
107719|NCT01557920|P2|Participant Flow|Sevoflurane First, Then Propofol|"The healthy subject will be anesthetized first with Sevoflurane, and secondarily with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
107720|NCT01557920|P1|Participant Flow|Propofol First, Then Sevoflurane|"The healthy subject will be anesthetized first with Propofol, and secondarily with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
107721|NCT01557920|O2|Outcome|Wakefulness|
107722|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane|
107723|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (during baseline CO2).
107724|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (CO2 baseline).
107725|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (baseline CO2)
107726|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (during baseline CO2).
107727|NCT01557920|O1|Outcome|Wakefulness|Duty cycle (CO2 baseline)
107728|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (during baseline CO2).
107729|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (CO2 baseline).
107730|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (baseline CO2)
107731|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (during baseline CO2).
107732|NCT01557920|O1|Outcome|Wakefulness|Minute Ventilation (CO2 baseline)
107733|NCT01557920|O4|Outcome|Tonic Genioglossus Activity (Deep Anesthesia)|Tonic Genioglossus activity (deep anesthesia)
107734|NCT01557920|O3|Outcome|Phasic Genioglossus Activity (Deep Anesthesia)|Phasic activity (Peak activity - Tonic activity)
107735|NCT01557920|O2|Outcome|Tonic Genioglossus Activity (Light Anesthesia)|Tonic Genioglossus activity (light anesthesia)
107736|NCT01557920|O1|Outcome|Phasic Genioglossus Activity (Light Anesthesia)|Phasic activity (Peak activity - Tonic activity)
107737|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|
107738|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|
107739|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|
107740|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|
107741|NCT01557920|O1|Outcome|Wakefulness|
107742|NCT01557920|O6|Outcome|Wakefulness (With CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during wakefulness (with CO2+4 and +8 insufflation).
107743|NCT01557920|O5|Outcome|Wakefulness (During Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia (during baseline CO2).
107744|NCT01557920|O4|Outcome|Anesthesia With Propofol and Sevoflurane (CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during anesthesia (with CO2+4 and +8 insufflation).
107745|NCT01557920|O3|Outcome|Anesthesia With Propofol and Sevoflurane (Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (during baseline CO2).
107746|NCT01557920|O2|Outcome|Wakefulness (All Cases)|Proportion of pathological (inspiratory) swallows during wakefulness (across CO2 levels)
107747|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane (All Cases)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (across carbon-dioxide (CO2) levels).
107748|NCT01557920|O2|Outcome|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
107749|NCT01557920|O1|Outcome|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
107750|NCT01557920|E2|Reported Event|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
107751|NCT01557920|E1|Reported Event|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
107752|NCT01557894|B3|Baseline|Total|Total of all reporting groups
107753|NCT01557894|B2|Baseline|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107754|NCT01557894|B1|Baseline|Waitlist Control Group|Wait-list control group
107755|NCT01557894|P2|Participant Flow|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107756|NCT01557894|P1|Participant Flow|Waitlist Control Group|"Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.~Starting from week 10 these participants received the active intervention."
107757|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107758|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
107759|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107760|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
107761|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107762|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
107763|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107764|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
107765|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107766|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
107767|NCT01557894|E2|Reported Event|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
107768|NCT01557894|E1|Reported Event|Waitlist Control Group|Wait-list control group
107769|NCT01557868|B3|Baseline|Total|Total of all reporting groups
107770|NCT01557868|B2|Baseline|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
107771|NCT01557868|B1|Baseline|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
107772|NCT01557868|P2|Participant Flow|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
107773|NCT01557868|P1|Participant Flow|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
107774|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
107775|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
107776|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
107777|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
107778|NCT01557868|E2|Reported Event|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
107779|NCT01557868|E1|Reported Event|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
107780|NCT01557842|B3|Baseline|Total|Total of all reporting groups
107781|NCT01557842|B2|Baseline|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
107782|NCT01557842|B1|Baseline|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
107783|NCT01557842|P2|Participant Flow|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
107784|NCT01557842|P1|Participant Flow|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
107785|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
107786|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
107787|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
107788|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
107789|NCT01557842|E2|Reported Event|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
107790|NCT01557842|E1|Reported Event|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
107791|NCT01557699|B4|Baseline|Total|Total of all reporting groups
107792|NCT01557699|B3|Baseline|Subcutaneous Meales Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107793|NCT01557699|B2|Baseline|PMV SoloventTM|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107794|NCT01557699|B1|Baseline|PMV Puffhaler®|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107795|NCT01557699|P3|Participant Flow|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107796|NCT01557699|P2|Participant Flow|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107797|NCT01557699|P1|Participant Flow|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107798|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107799|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107800|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107801|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107802|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107803|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107804|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107805|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107806|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107807|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107808|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107809|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107810|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107811|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107812|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107813|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107814|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107815|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107816|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107817|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107818|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107819|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
107820|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
107821|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
107822|NCT01557699|O3|Outcome|Subcutaneous Meales Vaccine|Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
107823|NCT01557699|O2|Outcome|PMV SoloventTM|Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
107824|NCT01557699|O1|Outcome|PMV Puffhaler®|Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
107825|NCT01557699|E3|Reported Event|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.~N=20"
107826|NCT01557699|E2|Reported Event|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.~N=20"
107827|NCT01557699|E1|Reported Event|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.~N=20"
107828|NCT01555567|B5|Baseline|Total|Total of all reporting groups
107846|NCT01555567|E3|Reported Event|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107829|NCT01555567|B4|Baseline|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107830|NCT01555567|B3|Baseline|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107831|NCT01555567|B2|Baseline|Standard of Care|This group will undergo standard ACL rehabilitation
107832|NCT01555567|B1|Baseline|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
107833|NCT01555567|P4|Participant Flow|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107834|NCT01555567|P3|Participant Flow|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107835|NCT01555567|P2|Participant Flow|Standard of Care|This group will undergo standard ACL rehabilitation
107836|NCT01555567|P1|Participant Flow|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo neuromuscular electrical stimulation (NMES) following anterior cruciate ligament (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
107837|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107838|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107839|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
107840|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
107841|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107842|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107843|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
107844|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
107845|NCT01555567|E4|Reported Event|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
107847|NCT01555567|E2|Reported Event|Standard of Care|This group will undergo standard ACL rehabilitation
107848|NCT01555567|E1|Reported Event|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
107849|NCT01557595|B1|Baseline|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
107850|NCT01557595|P1|Participant Flow|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
107851|NCT01557595|O1|Outcome|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
107852|NCT01557595|E1|Reported Event|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
107853|NCT01557582|B1|Baseline|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107854|NCT01557582|P1|Participant Flow|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107855|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107856|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107857|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107858|NCT01557582|E1|Reported Event|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
107859|NCT01557569|B3|Baseline|Total|Total of all reporting groups
107860|NCT01557569|B2|Baseline|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
107861|NCT01557569|B1|Baseline|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
107862|NCT01557569|P2|Participant Flow|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
107863|NCT01557569|P1|Participant Flow|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
107864|NCT01557569|O2|Outcome|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
107865|NCT01557569|O1|Outcome|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
107866|NCT01557569|E2|Reported Event|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
107867|NCT01557569|E1|Reported Event|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
107868|NCT01557504|B3|Baseline|Total|Total of all reporting groups
107869|NCT01557504|B2|Baseline|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107870|NCT01557504|B1|Baseline|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107871|NCT01557504|P2|Participant Flow|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107872|NCT01557504|P1|Participant Flow|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107873|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107874|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107875|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107876|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107877|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107878|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107879|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107880|NCT01557504|O2|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107881|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107882|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107883|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107884|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107885|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107886|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
108053|NCT01556997|E2|Reported Event|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
107887|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107888|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 9.
107889|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 6.
107890|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 4.
107891|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
107892|NCT01557504|E2|Reported Event|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107893|NCT01557504|E1|Reported Event|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
107894|NCT01557348|B3|Baseline|Total|Total of all reporting groups
107895|NCT01557348|B2|Baseline|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107896|NCT01557348|B1|Baseline|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107897|NCT01557348|P2|Participant Flow|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107898|NCT01557348|P1|Participant Flow|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107899|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107900|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107901|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107902|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107903|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107904|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107905|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107906|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107907|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107908|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107909|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107910|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107911|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107912|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107913|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107914|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107915|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107916|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
108083|NCT01556763|P3|Participant Flow|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
107917|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107918|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107919|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107920|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107921|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107922|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107923|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107924|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107925|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107926|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107927|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107928|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107929|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107930|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107931|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107932|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107933|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107934|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107935|NCT01557348|E2|Reported Event|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107936|NCT01557348|E1|Reported Event|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
107937|NCT01557322|B3|Baseline|Total|Total of all reporting groups
107938|NCT01557322|B2|Baseline|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107939|NCT01557322|B1|Baseline|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107940|NCT01557322|P2|Participant Flow|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107941|NCT01557322|P1|Participant Flow|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107942|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108051|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
108052|NCT01556997|E3|Reported Event|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
107943|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107944|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107945|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107946|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107947|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107948|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107949|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107950|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107951|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107952|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107953|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107954|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107955|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107956|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107957|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107958|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107959|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107960|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107961|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107962|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107963|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107964|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107965|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107966|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107967|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107968|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107969|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107970|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107971|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107972|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107973|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107974|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107975|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107976|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107977|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107978|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107979|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107980|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107981|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107982|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107983|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107984|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107985|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107986|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107987|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107988|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107989|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107990|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107991|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107992|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107993|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107994|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107995|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107996|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107997|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107998|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
107999|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108000|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108001|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108002|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108003|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108004|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108005|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108006|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108007|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108008|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108009|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108010|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108011|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108012|NCT01557322|E2|Reported Event|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108013|NCT01557322|E1|Reported Event|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
108014|NCT01557283|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108015|NCT01557283|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108016|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108017|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108018|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108019|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108020|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108247|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108021|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108022|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108023|NCT01557283|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
108024|NCT01557166|B3|Baseline|Total|Total of all reporting groups
108025|NCT01557166|B2|Baseline|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108026|NCT01557166|B1|Baseline|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108027|NCT01557166|P2|Participant Flow|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108028|NCT01557166|P1|Participant Flow|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108029|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108030|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108031|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108032|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108033|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108034|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108035|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108036|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108037|NCT01557166|E2|Reported Event|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108038|NCT01557166|E1|Reported Event|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
108039|NCT01556997|B4|Baseline|Total|Total of all reporting groups
108040|NCT01556997|B3|Baseline|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
108041|NCT01556997|B2|Baseline|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
108042|NCT01556997|B1|Baseline|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
108043|NCT01556997|P3|Participant Flow|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
108044|NCT01556997|P2|Participant Flow|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
108045|NCT01556997|P1|Participant Flow|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
108046|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
108047|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
108048|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
108049|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
108050|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
108248|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
108054|NCT01556997|E1|Reported Event|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
108055|NCT01556932|B1|Baseline|All Participants|"All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.~Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.~Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol."
108056|NCT01556932|P2|Participant Flow|Placebo-ABH Gel|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.
108057|NCT01556932|P1|Participant Flow|ABH Gel- Placebo|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
108058|NCT01556932|O2|Outcome|Placebo|Placebo applied topically for 2 minutes.
108059|NCT01556932|O1|Outcome|ABH Gel|ABH Gel applied topically for 2 minutes.
108060|NCT01556932|E1|Reported Event|Arm A and Arm B|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically over 2 minutes.
108061|NCT01556906|B1|Baseline|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108062|NCT01556906|P1|Participant Flow|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108063|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108064|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108065|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108066|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108067|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108068|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108069|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108070|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108071|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108072|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108073|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108074|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108075|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108076|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108077|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108078|NCT01556906|E1|Reported Event|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
108079|NCT01556763|B4|Baseline|Total|Total of all reporting groups
108080|NCT01556763|B3|Baseline|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108081|NCT01556763|B2|Baseline|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108082|NCT01556763|B1|Baseline|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108249|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108084|NCT01556763|P2|Participant Flow|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108085|NCT01556763|P1|Participant Flow|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108086|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108087|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108088|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108089|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108090|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108091|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108092|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108093|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108094|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108095|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108096|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108097|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108098|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108099|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108100|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108101|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108102|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108103|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108104|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108105|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108106|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108107|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108108|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108109|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108110|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108111|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108112|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108113|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108114|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108115|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108116|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108117|NCT01556763|E3|Reported Event|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
108118|NCT01556763|E2|Reported Event|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
108119|NCT01556763|E1|Reported Event|Placebo|Matching placebo was administered as one capsule per day for 21 days.
108120|NCT01555463|B3|Baseline|Total|Total of all reporting groups
108121|NCT01555463|B2|Baseline|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108122|NCT01555463|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108123|NCT01555463|P2|Participant Flow|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108124|NCT01555463|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108125|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108126|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108127|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108128|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108129|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108130|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108131|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108132|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108133|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108134|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108250|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
108135|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108136|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108137|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108138|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108139|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108140|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108141|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108142|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108143|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108144|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108145|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108146|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108147|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108148|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108149|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108150|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108151|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108152|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108153|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108154|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108155|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108156|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108157|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108158|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108159|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108160|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108161|NCT01555463|E2|Reported Event|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
108162|NCT01555463|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
108163|NCT01556724|B3|Baseline|Total|Total of all reporting groups
108164|NCT01556724|B2|Baseline|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108165|NCT01556724|B1|Baseline|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108179|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108180|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108226|NCT01556451|E1|Reported Event|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108166|NCT01556724|P2|Participant Flow|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108167|NCT01556724|P1|Participant Flow|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108168|NCT01556724|O2|Outcome|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108169|NCT01556724|O1|Outcome|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108170|NCT01556724|E2|Reported Event|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108171|NCT01556724|E1|Reported Event|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
108172|NCT01556633|B3|Baseline|Total|Total of all reporting groups
108173|NCT01556633|B2|Baseline|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108174|NCT01556633|B1|Baseline|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108175|NCT01556633|P2|Participant Flow|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108176|NCT01556633|P1|Participant Flow|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108177|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108178|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108227|NCT01556204|B3|Baseline|Total|Total of all reporting groups
108181|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108182|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108183|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108184|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108185|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108186|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108187|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108188|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108189|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108190|NCT01556633|O1|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108191|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108192|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108193|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108194|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108195|NCT01556633|E2|Reported Event|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
108196|NCT01556633|E1|Reported Event|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
108197|NCT01556594|B4|Baseline|Total|Total of all reporting groups
108198|NCT01556594|B3|Baseline|Group 3|Med dose IN followed by SC injection followed by high dose IN of glucagon
108199|NCT01556594|B2|Baseline|Group 2|Low dose IN followed by med dose IN followed by SC injection followed by high dose IN of glucagon
108200|NCT01556594|B1|Baseline|Group 1|Low dose IN followed by med dose IN followed by SC injection of glucagon
108201|NCT01556594|P3|Participant Flow|Gp 3: Med Dose IN, SC, High Dose IN|Med dose IN followed by SC followed by high dose IN glucagon
108202|NCT01556594|P2|Participant Flow|Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN|Low dose IN followed by medium dose IN followed by SC followed by high dose IN glucagon
108203|NCT01556594|P1|Participant Flow|Gp 1: Low Dose IN, Med Dose IN, SC|Low dose IN followed by med dose IN followed by SC injection of glucagon
108204|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
108205|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
108206|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
108207|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
108208|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
108209|NCT01556594|O3|Outcome|High Dose Novel Form'n|high dose novel formulation
108210|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
108211|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
108212|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
108213|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
108214|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
108215|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
108216|NCT01556594|E4|Reported Event|Medium Dose Novel Form'n|Medium dose novel formulation
108217|NCT01556594|E3|Reported Event|High Dose Novel Form'n|high dose novel formulation
108218|NCT01556594|E2|Reported Event|Low Dose Novel Form'n|Low dose novel formulation
108219|NCT01556594|E1|Reported Event|SC Glucagon Injection|SC glucagon injection 1 mg
108220|NCT01556451|B1|Baseline|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108221|NCT01556451|P1|Participant Flow|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108222|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108223|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108224|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108225|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
108228|NCT01556204|B2|Baseline|Laparoscopic|Laparoscopic surgery
108230|NCT01556204|P2|Participant Flow|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108231|NCT01556204|P1|Participant Flow|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108232|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108233|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108234|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108235|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108236|NCT01556204|E2|Reported Event|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108237|NCT01556204|E1|Reported Event|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
108238|NCT01556165|B3|Baseline|Total|Total of all reporting groups
108239|NCT01556165|B2|Baseline|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108240|NCT01556165|B1|Baseline|Placebo|placebo: tablets, once daily, orally
108241|NCT01556165|P2|Participant Flow|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108242|NCT01556165|P1|Participant Flow|Placebo|placebo: tablets, once daily, orally
108243|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108244|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
108251|NCT01556165|E2|Reported Event|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
108252|NCT01556165|E1|Reported Event|Placebo|placebo: tablets, once daily, orally
108253|NCT01556061|B3|Baseline|Total|Total of all reporting groups
108254|NCT01556061|B2|Baseline|D-MAC First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108255|NCT01556061|B1|Baseline|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108256|NCT01556061|P2|Participant Flow|D-MAC First, Then CMAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108257|NCT01556061|P1|Participant Flow|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108258|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108259|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108260|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108261|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108262|NCT01556061|O2|Outcome|D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108263|NCT01556061|O1|Outcome|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108264|NCT01556061|E2|Reported Event|DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
108265|NCT01556061|E1|Reported Event|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
108266|NCT01555983|B1|Baseline|All Study Participants|All participants received all interventions
108267|NCT01555983|P6|Participant Flow|6.7%THC First, Then 2.9%THC, Then Placebo|6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
108268|NCT01555983|P5|Participant Flow|6.7%THC First, Then Placebo, Then 2.9%THC|6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
108269|NCT01555983|P4|Participant Flow|2.9%THC First, Then 6.7%THC, Then Placebo|2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
108270|NCT01555983|P3|Participant Flow|2.9%THC First, Then Placebo, Then 6.7%THC|2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)
108271|NCT01555983|P2|Participant Flow|Placebo First, Then 6.7%THC, Then 2.9%THC|Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
108272|NCT01555983|P1|Participant Flow|Placebo First, Then 2.9%THC, Then 6.7% THC|Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).
108273|NCT01555983|O3|Outcome|6.7% THC|Vaporization of Cannabis 6.7% THC
108274|NCT01555983|O2|Outcome|2.9% THC|Vaporization of Cannabis 2.9% THC
108275|NCT01555983|O1|Outcome|Placebo THC|Session at which placebo THC was administered
108276|NCT01555983|E3|Reported Event|6.7% THC|Vaporization of Cannabis 6.7% THC
108277|NCT01555983|E2|Reported Event|2.9% THC|Vaporization of Cannabis 2.9% THC
108278|NCT01555983|E1|Reported Event|Placebo THC|Vaporization of Cannabis Placebo THC
108279|NCT01555931|B3|Baseline|Total|Total of all reporting groups
108280|NCT01555931|B2|Baseline|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108281|NCT01555931|B1|Baseline|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108282|NCT01555931|P2|Participant Flow|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108283|NCT01555931|P1|Participant Flow|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108284|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108285|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108286|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108287|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108288|NCT01555931|E2|Reported Event|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108289|NCT01555931|E1|Reported Event|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
108290|NCT01555164|B3|Baseline|Total|Total of all reporting groups
108291|NCT01555164|B2|Baseline|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108292|NCT01555164|B1|Baseline|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108293|NCT01555164|P2|Participant Flow|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108294|NCT01555164|P1|Participant Flow|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108295|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108296|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108297|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108298|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108330|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108331|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108332|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108299|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108300|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108301|NCT01555164|E2|Reported Event|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
108302|NCT01555164|E1|Reported Event|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
108303|NCT01555151|B5|Baseline|Total|Total of all reporting groups
108304|NCT01555151|B4|Baseline|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108305|NCT01555151|B3|Baseline|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108306|NCT01555151|B2|Baseline|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108307|NCT01555151|B1|Baseline|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108308|NCT01555151|P4|Participant Flow|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108309|NCT01555151|P3|Participant Flow|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108310|NCT01555151|P2|Participant Flow|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108311|NCT01555151|P1|Participant Flow|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108312|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108313|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108314|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108315|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108316|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108317|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108318|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108319|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108320|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108321|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108322|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108323|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108324|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108325|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108326|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108327|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108328|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108329|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108535|NCT01553708|E1|Reported Event|Epidermal Growth Factor With Silver Sulfadiazine Cream|
108333|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108334|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108335|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108336|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108337|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108338|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108339|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108340|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108341|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108342|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108343|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108344|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108345|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108346|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108347|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108348|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108349|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108350|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108351|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108352|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108353|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108354|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108355|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108356|NCT01555151|E5|Reported Event|Total|Total
108357|NCT01555151|E4|Reported Event|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
108358|NCT01555151|E3|Reported Event|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
108359|NCT01555151|E2|Reported Event|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
108360|NCT01555151|E1|Reported Event|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
108361|NCT01555138|B3|Baseline|Total|Total of all reporting groups
108362|NCT01555138|B2|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108363|NCT01555138|B1|Baseline|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108364|NCT01555138|P2|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108365|NCT01555138|P1|Participant Flow|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108366|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108367|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108368|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108369|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108370|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108371|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108372|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108643|NCT01552915|B4|Baseline|Total|Total of all reporting groups
108373|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108374|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108375|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108376|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108377|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108378|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108379|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108380|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108381|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108382|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108383|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108384|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108385|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108386|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108387|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108388|NCT01555138|E2|Reported Event|Salmeterol/Fluticasone|Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
108389|NCT01555138|E1|Reported Event|Indacaterol|Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
108390|NCT01555073|B5|Baseline|Total|Total of all reporting groups
108391|NCT01555073|B4|Baseline|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
108392|NCT01555073|B3|Baseline|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
108393|NCT01555073|B2|Baseline|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
108394|NCT01555073|B1|Baseline|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
108395|NCT01555073|P4|Participant Flow|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
108396|NCT01555073|P3|Participant Flow|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
108397|NCT01555073|P2|Participant Flow|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
108398|NCT01555073|P1|Participant Flow|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
108399|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
108400|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
108401|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
108402|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
108403|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
108404|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
108405|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
108406|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
108407|NCT01555073|E4|Reported Event|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
108408|NCT01555073|E3|Reported Event|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
108409|NCT01555073|E2|Reported Event|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
108410|NCT01555073|E1|Reported Event|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
108411|NCT01554982|B1|Baseline|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108412|NCT01554982|P1|Participant Flow|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108413|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108414|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108415|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108416|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108417|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108418|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108419|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108420|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108421|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108422|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108423|NCT01554982|E1|Reported Event|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
108424|NCT01554904|B1|Baseline|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
108425|NCT01554904|P1|Participant Flow|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
108426|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
108427|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
108428|NCT01554904|E1|Reported Event|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
108429|NCT01554891|B4|Baseline|Total|Total of all reporting groups
108430|NCT01554891|B3|Baseline|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
108431|NCT01554891|B2|Baseline|Comparison of SAFE-TBI and VA Screen|100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
108499|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108432|NCT01554891|B1|Baseline|Test-Retest Reliability of SAFE-TBI|100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
108433|NCT01554891|P3|Participant Flow|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
108434|NCT01554891|P2|Participant Flow|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
108435|NCT01554891|P1|Participant Flow|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
108436|NCT01554891|O1|Outcome|Sensitivity and Specificity of SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
108437|NCT01554891|O1|Outcome|Comparison of SAFE-TBI and VA Screen|Veterans
108438|NCT01554891|O1|Outcome|Test-Retest Reliability of SAFE-TBI|Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
108439|NCT01554891|E3|Reported Event|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
108440|NCT01554891|E2|Reported Event|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
108441|NCT01554891|E1|Reported Event|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
108442|NCT01554241|B5|Baseline|Total|Total of all reporting groups
108443|NCT01554241|B4|Baseline|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
108444|NCT01554241|B3|Baseline|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
108445|NCT01554241|B2|Baseline|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
108446|NCT01554241|B1|Baseline|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
108447|NCT01554241|P4|Participant Flow|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
108448|NCT01554241|P3|Participant Flow|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
108449|NCT01554241|P2|Participant Flow|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
108450|NCT01554241|P1|Participant Flow|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
108451|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
108452|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
108453|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
108454|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
108455|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
108456|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
108457|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
108458|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
108459|NCT01554241|E4|Reported Event|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
108460|NCT01554241|E3|Reported Event|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
108461|NCT01554241|E2|Reported Event|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
108462|NCT01554241|E1|Reported Event|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
108463|NCT01554176|B3|Baseline|Total|Total of all reporting groups
108464|NCT01554176|B2|Baseline|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108465|NCT01554176|B1|Baseline|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108466|NCT01554176|P5|Participant Flow|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
108467|NCT01554176|P4|Participant Flow|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108468|NCT01554176|P3|Participant Flow|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108469|NCT01554176|P2|Participant Flow|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108470|NCT01554176|P1|Participant Flow|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108471|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
108472|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108473|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108474|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
108475|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108476|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108477|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108478|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108479|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108480|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108481|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108482|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108483|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108484|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108485|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108486|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108487|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108488|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108489|NCT01554176|E5|Reported Event|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
108490|NCT01554176|E4|Reported Event|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108491|NCT01554176|E3|Reported Event|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
108492|NCT01554176|E2|Reported Event|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
108493|NCT01554176|E1|Reported Event|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
108494|NCT01554163|B3|Baseline|Total|Total of all reporting groups
108495|NCT01554163|B2|Baseline|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108496|NCT01554163|B1|Baseline|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108497|NCT01554163|P2|Participant Flow|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108498|NCT01554163|P1|Participant Flow|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108500|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108501|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108502|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108503|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108504|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108505|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108506|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108507|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108508|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108509|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108510|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108511|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108512|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108513|NCT01554163|E2|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
108514|NCT01554163|E1|Reported Event|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
108515|NCT01553851|B1|Baseline|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108516|NCT01553851|P1|Participant Flow|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108517|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108518|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108519|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108520|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108521|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108522|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108523|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108524|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108525|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108526|NCT01553851|E1|Reported Event|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
108527|NCT01553708|B3|Baseline|Total|Total of all reporting groups
108528|NCT01553708|B2|Baseline|Silver Zinc Sulfadiazine Cream|
108529|NCT01553708|B1|Baseline|Epidermal Growth Factor With Silver Sulfadiazine Cream|
108530|NCT01553708|P2|Participant Flow|Silver Zinc Sulfadiazine Cream|
108531|NCT01553708|P1|Participant Flow|Epidermal Growth Factor With Silver Sulfadiazine Cream|
108532|NCT01553708|O2|Outcome|Silver Zinc Sulfadiazine Cream|Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
108533|NCT01553708|O1|Outcome|Epidermal Growth Factor With Silver Sulfadiazine Cream|Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
108534|NCT01553708|E2|Reported Event|Silver Zinc Sulfadiazine Cream|
108536|NCT01553539|B1|Baseline|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
108537|NCT01553539|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.
108538|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
108539|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
108540|NCT01553539|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
108541|NCT01553318|B3|Baseline|Total|Total of all reporting groups
108542|NCT01553318|B2|Baseline|Placebo|Participants who received the placebo
108543|NCT01553318|B1|Baseline|Ketotifen Group|Participants who received the active drug - ketotifen
108544|NCT01553318|P2|Participant Flow|Placebo|Placebo medication
108545|NCT01553318|P1|Participant Flow|Ketotifen|ketotifen active group
108546|NCT01553318|O2|Outcome|Placebo|placebo group
108547|NCT01553318|O1|Outcome|Ketotifen|active drug group
108548|NCT01553318|O2|Outcome|Placebo|placebo group
108549|NCT01553318|O1|Outcome|Ketotifen|active drug group
108550|NCT01553318|O2|Outcome|Placebo|placebo group
108551|NCT01553318|O1|Outcome|Ketotifen|active drug group
108552|NCT01553318|O2|Outcome|Placebo|received placebo
108553|NCT01553318|O1|Outcome|Ketotifen|Ketotifen active drug
108554|NCT01553318|E2|Reported Event|Placebo|received placebo
108555|NCT01553318|E1|Reported Event|Ketotifen|Received ketotifen the active drug
108556|NCT01553292|B1|Baseline|Angiocath Surfactant|Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108557|NCT01553292|P1|Participant Flow|Surfactant Through Vascular Catheter|Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
108558|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108559|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108560|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108561|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108562|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108563|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108564|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108565|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108566|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108567|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108568|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108569|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108570|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108571|NCT01553292|E1|Reported Event|Angiocath Surfactant|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
108572|NCT01553240|B1|Baseline|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
108573|NCT01553240|P1|Participant Flow|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
108644|NCT01552915|B3|Baseline|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108574|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
108575|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
108576|NCT01553240|E1|Reported Event|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
108577|NCT01552954|B3|Baseline|Total|Total of all reporting groups
108578|NCT01552954|B2|Baseline|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108579|NCT01552954|B1|Baseline|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108580|NCT01552954|P2|Participant Flow|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108581|NCT01552954|P1|Participant Flow|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108582|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108583|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108584|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108585|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108586|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108587|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108588|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108589|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108590|NCT01552954|E2|Reported Event|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
108591|NCT01552954|E1|Reported Event|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
108592|NCT01552928|B5|Baseline|Total|Total of all reporting groups
108593|NCT01552928|B4|Baseline|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
108594|NCT01552928|B3|Baseline|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
108595|NCT01552928|B2|Baseline|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
108596|NCT01552928|B1|Baseline|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
108597|NCT01552928|P4|Participant Flow|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
108598|NCT01552928|P3|Participant Flow|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
108599|NCT01552928|P2|Participant Flow|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
108600|NCT01552928|P1|Participant Flow|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
108601|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108602|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108603|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108604|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108605|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108606|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108607|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108608|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108609|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108610|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108611|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108612|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108613|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108614|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108615|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108616|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 2.5 mg of anagrelide
108617|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 2.5 mg of anagrelide
108618|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 0.5 mg of anagrelide
108619|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 0.5 mg of anagrelide
108620|NCT01552928|O2|Outcome|Anagrelide 2.5mg (Females)|A single oral dose of 2.5 mg of anagrelide
108621|NCT01552928|O1|Outcome|Anagrelide 2.5mg (Males)|A single oral dose of 2.5 mg of anagrelide
108622|NCT01552928|O2|Outcome|Anagrelide 0.5 mg (Females)|A single oral dose of 0.5 mg of anagrelide
108623|NCT01552928|O1|Outcome|Anagrelide 0.5 mg (Males)|A single oral dose of 0.5 mg of anagrelide
108624|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108625|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108626|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108627|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108628|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108629|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108630|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108631|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108632|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108633|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108634|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108635|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108636|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
108637|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
108638|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
108639|NCT01552928|E4|Reported Event|Placebo|
108640|NCT01552928|E3|Reported Event|Moxifloxacin 400mg|
108641|NCT01552928|E2|Reported Event|Anagrelide 2.5mg|
108642|NCT01552928|E1|Reported Event|Anagrelide 0.5mg|
108645|NCT01552915|B2|Baseline|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108646|NCT01552915|B1|Baseline|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108647|NCT01552915|P3|Participant Flow|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108648|NCT01552915|P2|Participant Flow|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
108649|NCT01552915|P1|Participant Flow|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108650|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108651|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108652|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108653|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108654|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108655|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108656|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108657|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108658|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108659|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108660|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108661|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108662|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
108663|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
108664|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108665|NCT01552915|E3|Reported Event|OROS-MPH|Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
108666|NCT01552915|E2|Reported Event|SPD489|Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
108667|NCT01552915|E1|Reported Event|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
108668|NCT01552902|B4|Baseline|Total|Total of all reporting groups
108669|NCT01552902|B3|Baseline|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108670|NCT01552902|B2|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108671|NCT01552902|B1|Baseline|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108672|NCT01552902|P3|Participant Flow|Methylphenidate|Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108673|NCT01552902|P2|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108674|NCT01552902|P1|Participant Flow|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108675|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108676|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108677|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108678|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108736|NCT01552694|E1|Reported Event|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108737|NCT01552681|B3|Baseline|Total|Total of all reporting groups
108679|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108680|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108681|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108682|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108683|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108684|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108685|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108686|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108687|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108688|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108689|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108690|NCT01552902|E3|Reported Event|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
108691|NCT01552902|E2|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
108692|NCT01552902|E1|Reported Event|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
108693|NCT01552876|B1|Baseline|All Subjects|All subjects who were enrolled at baseline.
108694|NCT01552876|P2|Participant Flow|Nelfilcon A/ Etafilcon A/ Filcon II 3|nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
108695|NCT01552876|P1|Participant Flow|Etafilcon A/ Nelfilcon A/Filcon II 3|etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
108696|NCT01552876|O3|Outcome|Filcon II 3|All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
108697|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore Nelfilcon A
108698|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
108699|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
108700|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
108701|NCT01552876|O2|Outcome|Nelfilcon A.|Those who wore nelfilcon A.
108702|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
108703|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore nelfilcon A.
108704|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
108705|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
108706|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
108707|NCT01552876|E3|Reported Event|Filcon II 3|Those who wore Filcon II 3 during Phase II
108708|NCT01552876|E2|Reported Event|Nelfilcon A|Those subjects who wore nelfilcon A. (Phase I & II)
108709|NCT01552876|E1|Reported Event|Etafilcon A|Those subjects who wore etafilcon A. (Phase I & II)
108710|NCT01552772|B1|Baseline|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108711|NCT01552772|P1|Participant Flow|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108712|NCT01552772|O1|Outcome|Total|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108713|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108714|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108715|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108716|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108717|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108718|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108719|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108720|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108721|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108722|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108723|NCT01552772|E1|Reported Event|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
108724|NCT01552694|B3|Baseline|Total|Total of all reporting groups
108725|NCT01552694|B2|Baseline|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108726|NCT01552694|B1|Baseline|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108727|NCT01552694|P2|Participant Flow|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108728|NCT01552694|P1|Participant Flow|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108729|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108730|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108731|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108732|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108733|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108734|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
108735|NCT01552694|E2|Reported Event|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
108738|NCT01552681|B2|Baseline|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108739|NCT01552681|B1|Baseline|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108740|NCT01552681|P2|Participant Flow|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108741|NCT01552681|P1|Participant Flow|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108742|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108743|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108744|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108745|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108746|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108747|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108748|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108749|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108750|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108751|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108752|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108753|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108754|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108755|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108756|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108757|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108758|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108759|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108760|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108761|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108762|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108763|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108764|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108765|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108766|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108767|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108768|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108769|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108770|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108771|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108772|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108773|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108774|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108775|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108776|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108777|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108778|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108779|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108780|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108781|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108782|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108783|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108784|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108785|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108786|NCT01552681|E2|Reported Event|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
108787|NCT01552681|E1|Reported Event|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
108788|NCT01552603|B1|Baseline|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
108789|NCT01552603|P1|Participant Flow|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
108790|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
108791|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
108792|NCT01552603|E1|Reported Event|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
108793|NCT01552057|B3|Baseline|Total|Total of all reporting groups
108794|NCT01552057|B2|Baseline|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
108795|NCT01552057|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
108796|NCT01552057|P2|Participant Flow|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
108797|NCT01552057|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
108798|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108799|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108800|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108801|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108802|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108803|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108804|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108805|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108806|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108807|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108808|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108809|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108810|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108811|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108812|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108813|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108814|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108815|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108816|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108817|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108818|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108819|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108820|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108821|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108822|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108823|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108824|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
108825|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
108826|NCT01552057|E2|Reported Event|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
108827|NCT01552057|E1|Reported Event|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
108828|NCT01551888|B1|Baseline|Overall Study Population|All patients participating in the crossover study
108829|NCT01551888|P2|Participant Flow|Sequence 2|Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
108830|NCT01551888|P1|Participant Flow|Sequence 1|Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
108831|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
108832|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
108833|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
108834|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
108835|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
108836|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
108837|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
108838|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
108839|NCT01551888|E2|Reported Event|Formoterol 12 μg|Administered via Foradil® Aerolizer®
108840|NCT01551888|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed dose combination (FDC) administered via Almirall inhaler
108841|NCT01551355|B7|Baseline|Total|Total of all reporting groups
108842|NCT01551355|B6|Baseline|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
108843|NCT01551355|B5|Baseline|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher’s guide.
108844|NCT01551355|B4|Baseline|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
108845|NCT01551355|B3|Baseline|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
108846|NCT01551355|B2|Baseline|Usual Curriculum - Children|Control preschool facilities continued with their usual preschool curriculum
108847|NCT01551355|B1|Baseline|Healthy Habits Intervention - Children|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108848|NCT01551355|P6|Participant Flow|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
108849|NCT01551355|P5|Participant Flow|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
108850|NCT01551355|P4|Participant Flow|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
108851|NCT01551355|P3|Participant Flow|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
108852|NCT01551355|P2|Participant Flow|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108853|NCT01551355|P1|Participant Flow|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108854|NCT01551355|O2|Outcome|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108855|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108856|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108857|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108858|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108899|NCT01551082|P1|Participant Flow|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
108859|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108860|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108861|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108862|NCT01551355|E2|Reported Event|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
108863|NCT01551355|E1|Reported Event|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
108864|NCT01551303|B3|Baseline|Total|Total of all reporting groups
108865|NCT01551303|B2|Baseline|Placebo|Placebo, 0.77 ml, intranasal
108866|NCT01551303|B1|Baseline|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
108867|NCT01551303|P2|Participant Flow|Placebo|Placebo, 0.77 ml, intranasal
108868|NCT01551303|P1|Participant Flow|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
108869|NCT01551303|O2|Outcome|Placebo|Placebo, 0.77 ml, intranasal
108870|NCT01551303|O1|Outcome|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
108871|NCT01551303|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
108872|NCT01551303|E1|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
108873|NCT01551199|B1|Baseline|Multiple Channel Exposure Therapy (MCET)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
108874|NCT01551199|P1|Participant Flow|Multiple Channel Exosure Therapy (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
108875|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session interventinon targeting panic and PTSD symptoms.
108876|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session interventinon targeting panic and PTSD symptoms.
108877|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session interventinon targeting panic and PTSD symptoms.
108878|NCT01551199|E1|Reported Event|Arm 1|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
108879|NCT01551173|B3|Baseline|Total|Total of all reporting groups
108880|NCT01551173|B2|Baseline|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108881|NCT01551173|B1|Baseline|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108882|NCT01551173|P2|Participant Flow|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108883|NCT01551173|P1|Participant Flow|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108884|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108885|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108886|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108887|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108888|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108889|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108890|NCT01551173|E3|Reported Event|Total|
108891|NCT01551173|E2|Reported Event|LescolIR (Fluvastatin Sodium Immediate Release Capsule)|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
108892|NCT01551173|E1|Reported Event|LescolXL (Fluvastatin Sodium Extended Release Tablet)|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
108893|NCT01551095|B1|Baseline|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
108894|NCT01551095|P1|Participant Flow|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
108895|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
108896|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
108897|NCT01551095|E1|Reported Event|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
108898|NCT01551082|B1|Baseline|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
109003|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
109258|NCT01548287|E1|Reported Event|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
108900|NCT01551082|O1|Outcome|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
108901|NCT01551082|E1|Reported Event|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
108902|NCT01550965|B1|Baseline|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108903|NCT01550965|P1|Participant Flow|Participants Receiving Adalimumab|Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108904|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108905|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108906|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108907|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|"Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.~Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection"
108908|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108909|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108910|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108911|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108912|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108913|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108914|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108915|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108916|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108917|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
109004|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
109005|NCT01550289|E2|Reported Event|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108918|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108919|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108920|NCT01550965|E1|Reported Event|PARTICIPANTS RECEIVING ADALIMUMAB|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
108921|NCT01550952|B1|Baseline|Total Shoulder Arthroplasty Patients|
108922|NCT01550952|P1|Participant Flow|Total Shoulder Arthroplasty Patients|
108923|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
108924|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
108925|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
108926|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
108927|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
108928|NCT01550952|E1|Reported Event|Total Shoulder Arthroplasty Patients|
108929|NCT01550809|B3|Baseline|Total|Total of all reporting groups
108930|NCT01550809|B2|Baseline|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108931|NCT01550809|B1|Baseline|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
108932|NCT01550809|P2|Participant Flow|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108933|NCT01550809|P1|Participant Flow|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
108934|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108935|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
108936|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108937|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
108938|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108939|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
108940|NCT01550809|E2|Reported Event|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
108941|NCT01550809|E1|Reported Event|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
109006|NCT01550289|E1|Reported Event|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
109007|NCT01549977|B3|Baseline|Total|Total of all reporting groups
108942|NCT01550744|B1|Baseline|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
108943|NCT01550744|P3|Participant Flow|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
108944|NCT01550744|P2|Participant Flow|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
108945|NCT01550744|P1|Participant Flow|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
108946|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
108947|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
108948|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
108949|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
108950|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
108951|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
108952|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
108953|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
108954|NCT01550744|E3|Reported Event|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
108955|NCT01550744|E2|Reported Event|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
109008|NCT01549977|B2|Baseline|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109009|NCT01549977|B1|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
108956|NCT01550744|E1|Reported Event|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
108957|NCT01550705|B1|Baseline|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
108958|NCT01550705|P1|Participant Flow|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
108959|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
108960|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
108961|NCT01550705|E1|Reported Event|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
108962|NCT01550549|B1|Baseline|Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
108963|NCT01550549|P1|Participant Flow|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
108964|NCT01550549|O1|Outcome|Autopsy Within One Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
108965|NCT01550549|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 year of scan
108966|NCT01550549|O1|Outcome|All Autopsy Population|
108967|NCT01550549|O1|Outcome|All Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan
108968|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
108969|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
108970|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
108971|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
108972|NCT01550549|O1|Outcome|Florbetapir-PET Scans Primary Analysis Group|
108973|NCT01550549|E1|Reported Event|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
108974|NCT01550289|B3|Baseline|Total|Total of all reporting groups
108975|NCT01550289|B2|Baseline|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108976|NCT01550289|B1|Baseline|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108977|NCT01550289|P2|Participant Flow|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108978|NCT01550289|P1|Participant Flow|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108979|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
108980|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
108981|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108982|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108983|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
108984|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
108985|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
108986|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
108987|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108988|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108989|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108990|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108991|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108992|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108993|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108994|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108995|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108996|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108997|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
108998|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
108999|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
109000|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
109001|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
109002|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
109010|NCT01549977|P2|Participant Flow|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109011|NCT01549977|P1|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109012|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109013|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109014|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109015|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109016|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109017|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109018|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109019|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109020|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109021|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109022|NCT01549977|E2|Reported Event|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
109023|NCT01549977|E1|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
109024|NCT01549964|B5|Baseline|Total|Total of all reporting groups
109025|NCT01549964|B4|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109026|NCT01549964|B3|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109027|NCT01549964|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109028|NCT01549964|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109029|NCT01549964|P4|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109030|NCT01549964|P3|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109031|NCT01549964|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109032|NCT01549964|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109033|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109034|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109035|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109036|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109037|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109038|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109039|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109040|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109041|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109042|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109043|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109044|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109045|NCT01549964|E4|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109046|NCT01549964|E3|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109047|NCT01549964|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109048|NCT01549964|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
109049|NCT01549951|B1|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109050|NCT01549951|P1|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109051|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109052|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109053|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109054|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109055|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109056|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109057|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109058|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109059|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109060|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109061|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109062|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109063|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109064|NCT01549951|E1|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
109065|NCT01549925|B3|Baseline|Total|Total of all reporting groups
109066|NCT01549925|B2|Baseline|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
109067|NCT01549925|B1|Baseline|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
109068|NCT01549925|P2|Participant Flow|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
109069|NCT01549925|P1|Participant Flow|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
109070|NCT01549925|O2|Outcome|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
109071|NCT01549925|O1|Outcome|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
109072|NCT01549925|E2|Reported Event|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
109073|NCT01549925|E1|Reported Event|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
109074|NCT01549873|B3|Baseline|Total|Total of all reporting groups
109075|NCT01549873|B2|Baseline|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109076|NCT01549873|B1|Baseline|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109077|NCT01549873|P2|Participant Flow|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109078|NCT01549873|P1|Participant Flow|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109079|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109080|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109081|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109082|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109083|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109084|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109085|NCT01549873|E2|Reported Event|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
109086|NCT01549873|E1|Reported Event|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
109087|NCT01549860|B3|Baseline|Total|Total of all reporting groups
109115|NCT01549405|O1|Outcome|Control Group|Control group: Group that without intercostal nerve block
109088|NCT01549860|B2|Baseline|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109089|NCT01549860|B1|Baseline|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109090|NCT01549860|P2|Participant Flow|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109091|NCT01549860|P1|Participant Flow|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109092|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109093|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109094|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109095|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109096|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109097|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109098|NCT01549860|E2|Reported Event|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
109099|NCT01549860|E1|Reported Event|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
109100|NCT01549613|B3|Baseline|Total|Total of all reporting groups
109101|NCT01549613|B2|Baseline|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
109102|NCT01549613|B1|Baseline|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
109103|NCT01549613|P2|Participant Flow|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
109104|NCT01549613|P1|Participant Flow|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
109105|NCT01549613|O2|Outcome|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
109106|NCT01549613|O1|Outcome|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
109107|NCT01549613|E2|Reported Event|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
109108|NCT01549613|E1|Reported Event|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
109109|NCT01549405|B3|Baseline|Total|Total of all reporting groups
109110|NCT01549405|B2|Baseline|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
109111|NCT01549405|B1|Baseline|Control Group|Control group: Group that without intercostal nerve block
109112|NCT01549405|P2|Participant Flow|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
109113|NCT01549405|P1|Participant Flow|Control Group|Control group: Group that without intercostal nerve block
109114|NCT01549405|O2|Outcome|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
109116|NCT01549405|O2|Outcome|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
109117|NCT01549405|O1|Outcome|Control|Group that without intercostal nerve block
109118|NCT01549405|E2|Reported Event|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
109119|NCT01549405|E1|Reported Event|Control|Group that without intercostal nerve block
109120|NCT01549392|B3|Baseline|Total|Total of all reporting groups
109121|NCT01549392|B2|Baseline|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109122|NCT01549392|B1|Baseline|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109123|NCT01549392|P2|Participant Flow|DECT/MRS in Glioma Patients Not Receiving Avastin|"0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109124|NCT01549392|P1|Participant Flow|DECT/MRS in Patients Receiving Avastin|"3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks"
109125|NCT01549392|O2|Outcome|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109126|NCT01549392|O1|Outcome|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109127|NCT01549392|E2|Reported Event|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109128|NCT01549392|E1|Reported Event|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
109129|NCT01549340|B1|Baseline|Participants With AR|Participants with AR whose records were retrospectively reviewed
109130|NCT01549340|P1|Participant Flow|Participants With AR|Participants with AR whose records were retrospectively reviewed
109131|NCT01549340|O2|Outcome|Participants With AR Alone|Participants with AR alone who elected AIT and whose records were retrospectively reviewed
109132|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma who elected AIT and whose records were retrospectively reviewed
109133|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma whose records were retrospectively reviewed
109134|NCT01549340|O2|Outcome|Participants With AR Who Discontinued SLIT|Participants with AR whose records were retrospectively reviewed and discontinued SLIT
109135|NCT01549340|O1|Outcome|Participants With AR Who Discontinued SCIT|Participants with AR whose records were retrospectively reviewed and discontinued SCIT
109136|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
109137|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
109138|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
109139|NCT01549340|E1|Reported Event|Participants With AR|Participants with AR whose records were retrospectively reviewed
109140|NCT01549275|B3|Baseline|Total|Total of all reporting groups
109141|NCT01549275|B2|Baseline|AJCC TNM Staging > = IIIB HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
109142|NCT01549275|B1|Baseline|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
109143|NCT01549275|P2|Participant Flow|AJCC TNM Staging > = IIIB HCC Patients|29 patients belonged to AJCC TNM staging > = IIIB.
109144|NCT01549275|P1|Participant Flow|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
109145|NCT01549275|O5|Outcome|TNM Staging > = IIIB Patients Receiving Supportive Treatment|All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
109146|NCT01549275|O4|Outcome|TNM Staging > = IIIB Patients Receiving TACE|All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.
109147|NCT01549275|O3|Outcome|TNM Staging < = IIIA Patients Receiving Supportive Treatment|5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.
109148|NCT01549275|O2|Outcome|TNM Staging < = IIIA Patients Receiving TACE|All patients belonged to Child A classification and BCLC(Barcelona Clinic Liver Cancer classification) degree A or B.
109149|NCT01549275|O1|Outcome|TNM Staging < = IIIA Patients Receiving Curative Treatment|All patient belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree A (14 patients) or B (8 patients).
109150|NCT01549275|O2|Outcome|AJCC TNM Staging < = IIIA HCC Patients|
109151|NCT01549275|O1|Outcome|AJCC TNM Staging > = IIIB|
109152|NCT01549275|E1|Reported Event|HCC Patients Underwent FNA of Tumor|Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed.
109153|NCT01549041|B3|Baseline|Total|Total of all reporting groups
109154|NCT01549041|B2|Baseline|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
109155|NCT01549041|B1|Baseline|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
109156|NCT01549041|P2|Participant Flow|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
109157|NCT01549041|P1|Participant Flow|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
109158|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
109159|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
109160|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
109161|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
109162|NCT01549041|E2|Reported Event|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
109163|NCT01549041|E1|Reported Event|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
109164|NCT01549002|B3|Baseline|Total|Total of all reporting groups
109165|NCT01549002|B2|Baseline|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
109166|NCT01549002|B1|Baseline|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
109167|NCT01549002|P2|Participant Flow|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
109168|NCT01549002|P1|Participant Flow|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
109169|NCT01549002|O2|Outcome|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
109170|NCT01549002|O1|Outcome|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
109171|NCT01549002|E2|Reported Event|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
109201|NCT01548742|E2|Reported Event|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109202|NCT01548742|E1|Reported Event|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109172|NCT01549002|E1|Reported Event|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
109173|NCT01548885|B1|Baseline|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
109174|NCT01548885|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
109175|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
109176|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
109177|NCT01548885|E1|Reported Event|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
109178|NCT01548833|B1|Baseline|Overall|DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
109179|NCT01548833|P1|Participant Flow|Overall|All enrolled participants
109180|NCT01548833|O3|Outcome|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
109181|NCT01548833|O2|Outcome|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
109182|NCT01548833|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
109183|NCT01548833|E3|Reported Event|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
109184|NCT01548833|E2|Reported Event|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
109185|NCT01548833|E1|Reported Event|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
109186|NCT01548742|B3|Baseline|Total|Total of all reporting groups
109187|NCT01548742|B2|Baseline|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109188|NCT01548742|B1|Baseline|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109189|NCT01548742|P2|Participant Flow|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109190|NCT01548742|P1|Participant Flow|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109191|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109192|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109193|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109194|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109195|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109196|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109197|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109198|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109199|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
109200|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
109236|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
109203|NCT01548638|B1|Baseline|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109204|NCT01548638|P1|Participant Flow|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109205|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109206|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109207|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109208|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109209|NCT01548638|E1|Reported Event|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
109210|NCT01548417|B3|Baseline|Total|Total of all reporting groups
109211|NCT01548417|B2|Baseline|Placebo|Sugar Pill: placebo, oral pill, 7 days
109212|NCT01548417|B1|Baseline|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
109213|NCT01548417|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
109214|NCT01548417|P1|Participant Flow|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
109215|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
109216|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
109217|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
109218|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
109219|NCT01548417|E2|Reported Event|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
109220|NCT01548417|E1|Reported Event|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
109221|NCT01548287|B5|Baseline|Total|Total of all reporting groups
109222|NCT01548287|B4|Baseline|Placebo|Placebo daily
109223|NCT01548287|B3|Baseline|AZD5213 Dose C|AZD5213 6.0 mg daily
109224|NCT01548287|B2|Baseline|AZD5213 Dose B|AZD 5213 2.0 mg daily
109225|NCT01548287|B1|Baseline|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
109226|NCT01548287|P5|Participant Flow|Screening Only|Screening period only, not randomized
109227|NCT01548287|P4|Participant Flow|Placebo|Placebo daily
109228|NCT01548287|P3|Participant Flow|AZD5213 Dose C|AZD5213 6.0 mg daily
109229|NCT01548287|P2|Participant Flow|AZD5213 Dose B|AZD 5213 2.0 mg daily
109230|NCT01548287|P1|Participant Flow|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
109231|NCT01548287|O4|Outcome|Placebo|Placebo daily
109232|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
109233|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
109234|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
109235|NCT01548287|O4|Outcome|Placebo|Placebo daily
109259|NCT01547728|B1|Baseline|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
109260|NCT01547728|P1|Participant Flow|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
109261|NCT01547728|O1|Outcome|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
109262|NCT01547728|E1|Reported Event|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
109263|NCT01547715|B4|Baseline|Total|Total of all reporting groups
109264|NCT01547715|B3|Baseline|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
109265|NCT01547715|B2|Baseline|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1
109266|NCT01547715|B1|Baseline|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1
109267|NCT01547715|P3|Participant Flow|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
109268|NCT01547715|P2|Participant Flow|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
109269|NCT01547715|P1|Participant Flow|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
109270|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109271|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109272|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109273|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109274|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109275|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109276|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109277|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109278|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109279|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109280|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109281|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109282|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109283|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109284|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109285|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109286|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109287|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109288|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109289|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109290|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109291|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109292|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109293|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109294|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109295|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109296|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109297|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109298|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109299|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109300|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109301|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109302|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109303|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109304|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109305|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109306|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109307|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109308|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109309|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109310|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109311|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109312|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109313|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109314|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109315|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109316|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109317|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109318|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109319|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109320|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109321|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109322|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109323|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109324|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109325|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109326|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109327|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109328|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109329|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109330|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109331|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109332|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109333|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109334|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109335|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109336|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109337|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109338|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109339|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109340|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109341|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109342|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109343|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109344|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109345|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109346|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109347|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109348|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109568|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109349|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109350|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109351|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109352|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109353|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109354|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109355|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109356|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109357|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109358|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109359|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109360|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109361|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109362|NCT01547715|E4|Reported Event|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109363|NCT01547715|E3|Reported Event|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1
109364|NCT01547715|E2|Reported Event|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109365|NCT01547715|E1|Reported Event|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
109366|NCT01547598|B3|Baseline|Total|Total of all reporting groups
109367|NCT01547598|B2|Baseline|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109368|NCT01547598|B1|Baseline|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109369|NCT01547598|P2|Participant Flow|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109370|NCT01547598|P1|Participant Flow|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109371|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109372|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109373|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109374|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109375|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109376|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109377|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109378|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109379|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109380|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109381|NCT01547598|E3|Reported Event|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
109382|NCT01547598|E2|Reported Event|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
109383|NCT01547598|E1|Reported Event|Travatan® Z|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
109384|NCT01547299|B3|Baseline|Total|Total of all reporting groups
109385|NCT01547299|B2|Baseline|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109386|NCT01547299|B1|Baseline|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109387|NCT01547299|P2|Participant Flow|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109388|NCT01547299|P1|Participant Flow|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109389|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109390|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109391|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109392|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109393|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109394|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109395|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109396|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109397|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109398|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109399|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109400|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109401|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109402|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109403|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109404|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109405|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109406|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109407|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109408|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109409|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109410|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109411|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109412|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109413|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109414|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109415|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109416|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109417|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109418|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109419|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109420|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109421|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109422|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109423|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109424|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109425|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109426|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109427|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109428|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109429|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109430|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109431|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109432|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109433|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109434|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109435|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109436|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109437|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109438|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109439|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109440|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109441|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109442|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109443|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109444|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109445|NCT01547299|E2|Reported Event|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
109446|NCT01547299|E1|Reported Event|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
109447|NCT01547247|B3|Baseline|Total|Total of all reporting groups
109448|NCT01547247|B2|Baseline|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109449|NCT01547247|B1|Baseline|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109450|NCT01547247|P2|Participant Flow|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109451|NCT01547247|P1|Participant Flow|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109452|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109453|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109454|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109455|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109456|NCT01547247|E2|Reported Event|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109457|NCT01547247|E1|Reported Event|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
109458|NCT01547130|B3|Baseline|Total|Total of all reporting groups
109459|NCT01547130|B2|Baseline|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
109460|NCT01547130|B1|Baseline|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
109461|NCT01547130|P2|Participant Flow|HalfLytely Colon Prep (HCP)|Patients followed the preparation method according to the manufacturer's standard instructions.
109462|NCT01547130|P1|Participant Flow|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
109463|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
109569|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109464|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
109465|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.
109466|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.
109467|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Subjects rated the HCP as palatable
109468|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Subjects rated the SCC as palatable
109469|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
109470|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
109471|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.
109472|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.
109473|NCT01547130|E2|Reported Event|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
109474|NCT01547130|E1|Reported Event|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
109475|NCT01546922|B1|Baseline|All Participants|All participants completing both study periods
109476|NCT01546922|P2|Participant Flow|First a High Dose of HC Followed by a Low Dose of HC|First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
109477|NCT01546922|P1|Participant Flow|First a Low Dose of HC Followed by a High Dose of HC|First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight
109478|NCT01546922|O2|Outcome|High Dose of Hydrocortisone|Results from the participants while receiving the high dose of hydrocortisone
109479|NCT01546922|O1|Outcome|Low Dose of Hydrocortisone|Results from the participants while receiving the low dose of hydrocortisone
109480|NCT01546922|E2|Reported Event|High Dose of HC|Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
109481|NCT01546922|E1|Reported Event|Low Dose of HC|Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks
109482|NCT01546883|B1|Baseline|Dabigatran|Dabigatran
109483|NCT01546883|P1|Participant Flow|Dabigatran|"Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant~Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year"
109484|NCT01546883|O1|Outcome|Dabigatran|Dabigatran
109485|NCT01546883|E1|Reported Event|Dabigatran|Patients taking Dabigatran
109486|NCT01546688|B3|Baseline|Total|Total of all reporting groups
109487|NCT01546688|B2|Baseline|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109488|NCT01546688|B1|Baseline|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109489|NCT01546688|P2|Participant Flow|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109490|NCT01546688|P1|Participant Flow|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109491|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109492|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109493|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109494|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109495|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109496|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109497|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109498|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109499|NCT01546688|E2|Reported Event|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
109500|NCT01546688|E1|Reported Event|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
109501|NCT01546675|B3|Baseline|Total|Total of all reporting groups
109502|NCT01546675|B2|Baseline|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design
109503|NCT01546675|B1|Baseline|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109504|NCT01546675|P2|Participant Flow|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109505|NCT01546675|P1|Participant Flow|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109506|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109507|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109508|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109509|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109510|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109511|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109512|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109513|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109514|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109515|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|.Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109516|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
109517|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
109518|NCT01546675|E1|Reported Event|Cases|Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design.
109519|NCT01546649|B3|Baseline|Total|Total of all reporting groups
109520|NCT01546649|B2|Baseline|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109521|NCT01546649|B1|Baseline|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109522|NCT01546649|P2|Participant Flow|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
110136|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
109523|NCT01546649|P1|Participant Flow|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109524|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109525|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109526|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109527|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109528|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109529|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109530|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109531|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109532|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109533|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109534|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109535|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109536|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109537|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109538|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109539|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109540|NCT01546649|E2|Reported Event|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109541|NCT01546649|E1|Reported Event|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
109542|NCT01546636|B3|Baseline|Total|Total of all reporting groups
109543|NCT01546636|B2|Baseline|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109544|NCT01546636|B1|Baseline|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109545|NCT01546636|P2|Participant Flow|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109546|NCT01546636|P1|Participant Flow|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109547|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109548|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109549|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109550|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109551|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109552|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109553|NCT01546636|E2|Reported Event|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
109554|NCT01546636|E1|Reported Event|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
109555|NCT01546623|B3|Baseline|Total|Total of all reporting groups
109556|NCT01546623|B2|Baseline|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109557|NCT01546623|B1|Baseline|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109558|NCT01546623|P2|Participant Flow|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109559|NCT01546623|P1|Participant Flow|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109560|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109561|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109562|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109563|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109564|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109565|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109566|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109567|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109570|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109571|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109572|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109573|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109574|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109575|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109576|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109577|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109578|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109579|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109580|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109581|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109582|NCT01546623|E2|Reported Event|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
109583|NCT01546623|E1|Reported Event|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
109584|NCT01546519|B5|Baseline|Total|Total of all reporting groups
109585|NCT01546519|B4|Baseline|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109586|NCT01546519|B3|Baseline|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109587|NCT01546519|B2|Baseline|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109588|NCT01546519|B1|Baseline|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109589|NCT01546519|P4|Participant Flow|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109590|NCT01546519|P3|Participant Flow|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109591|NCT01546519|P2|Participant Flow|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109592|NCT01546519|P1|Participant Flow|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
109593|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
110022|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
109594|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109595|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109596|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
109597|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109598|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109599|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109600|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
109601|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109602|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109603|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109604|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
109605|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109661|NCT01546194|B2|Baseline|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
109606|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109607|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109608|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
109609|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109610|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109611|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109612|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109613|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109614|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109615|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109616|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109617|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109662|NCT01546194|B1|Baseline|Morning Consent|"Consent process consisting of information only provided on the morning of surgery~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
109761|NCT01545388|B3|Baseline|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109618|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109619|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109620|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109621|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109622|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109623|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109624|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109625|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109626|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109627|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109628|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109629|NCT01546519|E4|Reported Event|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109663|NCT01546194|P2|Participant Flow|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
109630|NCT01546519|E3|Reported Event|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109631|NCT01546519|E2|Reported Event|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109632|NCT01546519|E1|Reported Event|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
109633|NCT01546454|B1|Baseline|All Study Participants|
109634|NCT01546454|P1|Participant Flow|All Study Participants|
109635|NCT01546454|O3|Outcome|Steroid Effects|"Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
109636|NCT01546454|O2|Outcome|Contraceptive Effects|"Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.~Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days~leuprolide acetate: single 22.5 mg subcutaneous depot suspension"
109637|NCT01546454|O1|Outcome|Non-steroidal Effects|"Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
109638|NCT01546454|E1|Reported Event|All Study Participants|
109639|NCT01546402|B3|Baseline|Total|Total of all reporting groups
109640|NCT01546402|B2|Baseline|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
109641|NCT01546402|B1|Baseline|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
109642|NCT01546402|P2|Participant Flow|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
109643|NCT01546402|P1|Participant Flow|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
109664|NCT01546194|P1|Participant Flow|Morning Consent|Consent process consisting of information only provided on the morning of surgery
109762|NCT01545388|B2|Baseline|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109644|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
109645|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
109646|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
109647|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
109648|NCT01546402|E2|Reported Event|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
109649|NCT01546402|E1|Reported Event|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
109650|NCT01546285|B1|Baseline|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
109651|NCT01546285|P1|Participant Flow|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
109652|NCT01546285|O3|Outcome|B40 and PRO1000 - MAP|
109653|NCT01546285|O2|Outcome|B40 and PRO1000 - Diastolic BP|
109654|NCT01546285|O1|Outcome|B40 and PRO1000 - Systolic BP|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
109655|NCT01546285|E1|Reported Event|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
109656|NCT01546207|B1|Baseline|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
109657|NCT01546207|P1|Participant Flow|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
109658|NCT01546207|O1|Outcome|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
109659|NCT01546207|E1|Reported Event|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
109660|NCT01546194|B3|Baseline|Total|Total of all reporting groups
109697|NCT01545843|E3|Reported Event|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109665|NCT01546194|O2|Outcome|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
109666|NCT01546194|O1|Outcome|Morning Consent|Consent process consisting of information only provided on the morning of surgery
109667|NCT01546194|E2|Reported Event|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
109668|NCT01546194|E1|Reported Event|Morning Consent|Consent process consisting of information only provided on the morning of surgery
109669|NCT01546142|B3|Baseline|Total|Total of all reporting groups
109670|NCT01546142|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109671|NCT01546142|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109672|NCT01546142|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109673|NCT01546142|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109674|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109675|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109676|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109677|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109678|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109679|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109680|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109681|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109682|NCT01546142|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109683|NCT01546142|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
109684|NCT01545843|B4|Baseline|Total|Total of all reporting groups
109685|NCT01545843|B3|Baseline|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109686|NCT01545843|B2|Baseline|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109687|NCT01545843|B1|Baseline|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109688|NCT01545843|P3|Participant Flow|Early Risetime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
109689|NCT01545843|P2|Participant Flow|Late Bedtime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
109690|NCT01545843|P1|Participant Flow|No Sleep Deprivation|8 hours time in bed for two weeks plus fluoxetine for 8 weeks
109691|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109692|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109693|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109694|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109695|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109696|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
110132|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
109698|NCT01545843|E2|Reported Event|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109699|NCT01545843|E1|Reported Event|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
109700|NCT01545765|B1|Baseline|Lidocaine 7% and Tetracaine 7%|
109701|NCT01545765|P1|Participant Flow|Face 2 Application Times/ Thight 2 Application Times|
109702|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
109703|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
109704|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
109705|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
109706|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
109707|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
109708|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
109709|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
109710|NCT01545765|E1|Reported Event|Lidocaine 7% + Tetracaine 7%|
109711|NCT01545700|B7|Baseline|Total|Total of all reporting groups
109712|NCT01545700|B6|Baseline|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
109713|NCT01545700|B5|Baseline|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
109714|NCT01545700|B4|Baseline|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
109715|NCT01545700|B3|Baseline|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
109716|NCT01545700|B2|Baseline|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
109717|NCT01545700|B1|Baseline|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
109718|NCT01545700|P6|Participant Flow|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
109719|NCT01545700|P5|Participant Flow|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
109720|NCT01545700|P4|Participant Flow|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
109721|NCT01545700|P3|Participant Flow|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
109722|NCT01545700|P2|Participant Flow|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
109723|NCT01545700|P1|Participant Flow|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
109724|NCT01545700|O24|Outcome|Dexamethasone 8 mg 8-24 Hours-24 Hours|
109725|NCT01545700|O23|Outcome|Dexamethasone 8 mg 8-24 Hours-8 Hours|
109726|NCT01545700|O22|Outcome|Dexamethasone 8 mg 8-24 Hours-baseline|
109727|NCT01545700|O21|Outcome|Dexamethasone 4 mg 8-24 Hours-24 Hours|
109728|NCT01545700|O20|Outcome|Dexamethasone 4 mg 8-24 Hours-8 Hours|
109729|NCT01545700|O19|Outcome|Dexamethasone 4 mg 8-24 Hours-baseline|
109730|NCT01545700|O18|Outcome|Placebo 8-24 Hours-24 Hours|
109731|NCT01545700|O17|Outcome|Placebo 8-24 Hours-8 Hours|
109732|NCT01545700|O16|Outcome|Placebo 8-24 Hours Baseline|
109733|NCT01545700|O15|Outcome|Dexamethasone 8 mg 0-4 Hours-4 Hours|
109734|NCT01545700|O14|Outcome|Dexamethasone 8 mg 0-4 Hours-3 Hours|
109735|NCT01545700|O13|Outcome|Dexamethasone 8 mg 0-4 Hours-2 Hours|
109736|NCT01545700|O12|Outcome|Dexamethasone 8 mg 0-4 Hours-1 Hour|
109737|NCT01545700|O11|Outcome|Dexamethasone 8 mg 0-4 Hours-baseline|
109738|NCT01545700|O10|Outcome|Dexamethasone 4 mg 0-4 Hours-4 Hours|
109739|NCT01545700|O9|Outcome|Dexamethasone 4 mg 0-4 Hours-3 Hours|
109740|NCT01545700|O8|Outcome|Dexamethasone 4 mg 0-4 Hours-2 Hours|
109741|NCT01545700|O7|Outcome|Dexamethasone 4 mg 0-4 Hours-1 Hour|
109742|NCT01545700|O6|Outcome|Dexamethasone 4 mg 0-4 Hours-baseline|
109743|NCT01545700|O5|Outcome|Placebo 0-4 Hours-4 Hours|
109744|NCT01545700|O4|Outcome|Placebo 0-4 Hours-3 Hours|
109745|NCT01545700|O3|Outcome|Placebo 0-4 Hours-2 Hours|Placebo 0-4 hours-2 hours
109746|NCT01545700|O2|Outcome|Placebo 0-4 Hours-1 Hour|Placebo 0-4 hours-1 hour
109747|NCT01545700|O1|Outcome|Placebo 0-4 Hours-baseline|Placebo 0-4 hours baseline
109748|NCT01545700|O6|Outcome|Dexamethasone 8 mg 8-24 Hours|
109749|NCT01545700|O5|Outcome|Dexamethasone 4 mg 8-24 Hours|
109750|NCT01545700|O4|Outcome|Placebo 8-24 Hours|
109751|NCT01545700|O3|Outcome|Dexamethasone 8 mg 0-4 Hours|
109752|NCT01545700|O2|Outcome|Dexamethasone 4 mg 0-4 Hours|
109753|NCT01545700|O1|Outcome|Placebo 0-4 Hours|Placebo 0-4 hours baseline
109754|NCT01545700|E2|Reported Event|Dexamethasone Group|either 4 mg or 8 mg
109755|NCT01545700|E1|Reported Event|Control-saline Group|
109756|NCT01545518|B1|Baseline|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
109757|NCT01545518|P1|Participant Flow|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
109758|NCT01545518|O1|Outcome|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
109759|NCT01545518|E1|Reported Event|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover~No AE's."
109760|NCT01545388|B4|Baseline|Total|Total of all reporting groups
109763|NCT01545388|B1|Baseline|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109764|NCT01545388|P3|Participant Flow|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109765|NCT01545388|P2|Participant Flow|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109766|NCT01545388|P1|Participant Flow|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109767|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109768|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109769|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109770|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109771|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109772|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109773|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109774|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109775|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109776|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109777|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109778|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109779|NCT01545388|E3|Reported Event|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
109780|NCT01545388|E2|Reported Event|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
109781|NCT01545388|E1|Reported Event|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
109782|NCT01545336|B3|Baseline|Total|Total of all reporting groups
109783|NCT01545336|B2|Baseline|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
109784|NCT01545336|B1|Baseline|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
109785|NCT01545336|P2|Participant Flow|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
109786|NCT01545336|P1|Participant Flow|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
109787|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
109788|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
109789|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
109790|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
109791|NCT01545336|O2|Outcome|Placebo|"Placebo tablet by mouth once daily for 3 months~Placebo: 1 mg tablet to be taken 1 time daily"
109792|NCT01545336|O1|Outcome|Anastrozole|"1 mg tablet by mouth once daily for 3 months~Anastrozole: 1 mg tablet to be taken 1 time daily"
109793|NCT01545336|E2|Reported Event|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
109794|NCT01545336|E1|Reported Event|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
109795|NCT01545232|B3|Baseline|Total|Total of all reporting groups
109796|NCT01545232|B2|Baseline|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109797|NCT01545232|B1|Baseline|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109798|NCT01545232|P2|Participant Flow|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
110133|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
109799|NCT01545232|P1|Participant Flow|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109800|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109801|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109802|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109803|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109804|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109805|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109806|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109807|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109808|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109809|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109810|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109811|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109812|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109813|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
110011|NCT01544361|P2|Participant Flow|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
109814|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109815|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109816|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109817|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109818|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109819|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109820|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109821|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109822|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109823|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109824|NCT01545232|E2|Reported Event|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
109825|NCT01545232|E1|Reported Event|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
109826|NCT01545193|B3|Baseline|Total|Total of all reporting groups
109827|NCT01545193|B2|Baseline|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109828|NCT01545193|B1|Baseline|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109829|NCT01545193|P2|Participant Flow|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109830|NCT01545193|P1|Participant Flow|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109831|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109832|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109833|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109834|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109835|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109836|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109837|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109838|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109839|NCT01545193|E2|Reported Event|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109840|NCT01545193|E1|Reported Event|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
109841|NCT01544153|B5|Baseline|Total|Total of all reporting groups
109842|NCT01544153|B4|Baseline|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109843|NCT01544153|B3|Baseline|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109844|NCT01544153|B2|Baseline|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
109845|NCT01544153|B1|Baseline|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
109846|NCT01544153|P4|Participant Flow|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109847|NCT01544153|P3|Participant Flow|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109848|NCT01544153|P2|Participant Flow|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
109849|NCT01544153|P1|Participant Flow|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
109850|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109851|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
110012|NCT01544361|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
109852|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
109853|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
109854|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109855|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109856|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
109857|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
109858|NCT01544153|E4|Reported Event|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109859|NCT01544153|E3|Reported Event|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
109860|NCT01544153|E2|Reported Event|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
109861|NCT01544153|E1|Reported Event|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
109862|NCT01544062|B3|Baseline|Total|Total of all reporting groups
109863|NCT01544062|B2|Baseline|Normal Saline|Study subjects receiving placebo
109864|NCT01544062|B1|Baseline|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109865|NCT01544062|P2|Participant Flow|Normal Saline|Study subjects receiving placebo
109866|NCT01544062|P1|Participant Flow|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109867|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109868|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109869|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109870|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109871|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109872|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
110013|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
109873|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109874|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109875|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109876|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109877|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109878|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109879|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109880|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109881|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109882|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109883|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109884|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109885|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109886|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109887|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109888|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109889|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109890|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109891|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
110014|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110134|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
109892|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109893|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109894|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109895|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109896|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109897|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109898|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
109899|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109900|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
109901|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109902|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
109903|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109904|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
109905|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109906|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
109907|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109908|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109909|NCT01544062|E2|Reported Event|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109910|NCT01544062|E1|Reported Event|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
109911|NCT01544023|B1|Baseline|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
109912|NCT01544023|P1|Participant Flow|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
109913|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
109914|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
109915|NCT01544023|E1|Reported Event|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
109916|NCT01544998|B1|Baseline|Entire Study Population|Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.
109917|NCT01544998|P2|Participant Flow|Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo|First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
109918|NCT01544998|P1|Participant Flow|Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide|First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
109919|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109920|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109921|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109922|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109923|NCT01544998|E4|Reported Event|PDD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109924|NCT01544998|E3|Reported Event|PDD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109925|NCT01544998|E2|Reported Event|PSD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109926|NCT01544998|E1|Reported Event|PSD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
109927|NCT01544920|B3|Baseline|Total|Total of all reporting groups
109928|NCT01544920|B2|Baseline|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
109929|NCT01544920|B1|Baseline|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
109930|NCT01544920|P2|Participant Flow|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
110015|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110016|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
109931|NCT01544920|P1|Participant Flow|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
109932|NCT01544920|O2|Outcome|Arm 2a: BOC + Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
109933|NCT01544920|O1|Outcome|Arm 1a: Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
109934|NCT01544920|O2|Outcome|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
109935|NCT01544920|O1|Outcome|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
109936|NCT01544920|E2|Reported Event|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
109937|NCT01544920|E1|Reported Event|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
109938|NCT01544582|B4|Baseline|Total|Total of all reporting groups
109939|NCT01544582|B3|Baseline|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109940|NCT01544582|B2|Baseline|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109941|NCT01544582|B1|Baseline|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109942|NCT01544582|P4|Participant Flow|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109943|NCT01544582|P3|Participant Flow|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109944|NCT01544582|P2|Participant Flow|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109945|NCT01544582|P1|Participant Flow|All Included Participants|All CHC genotype-1 participants included in study.
109946|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109947|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109948|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109949|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109950|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
110017|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
110018|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
109951|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109952|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109953|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109954|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109955|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109956|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109957|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109958|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109959|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109960|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109961|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109962|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109963|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
110336|NCT01543685|E3|Reported Event|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
109964|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109965|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109966|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109967|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109968|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109969|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109970|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109971|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109972|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109973|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109974|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109975|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
110019|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110020|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110021|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
109976|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
109977|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
109978|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
109979|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
109980|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109981|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109982|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109983|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109984|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109985|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109986|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109987|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109988|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109989|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109990|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109991|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109992|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109993|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109994|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109995|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
109996|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
109997|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
109998|NCT01544582|O1|Outcome|All Included Participants|All CHC genotype-1 participants included in study.
109999|NCT01544582|E3|Reported Event|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
110000|NCT01544582|E2|Reported Event|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
110001|NCT01544582|E1|Reported Event|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
110002|NCT01544361|B6|Baseline|TOTAL|Total of all reporting groups
110003|NCT01544361|B5|Baseline|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110004|NCT01544361|B4|Baseline|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110005|NCT01544361|B3|Baseline|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110006|NCT01544361|B2|Baseline|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
110007|NCT01544361|B1|Baseline|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
110008|NCT01544361|P5|Participant Flow|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110009|NCT01544361|P4|Participant Flow|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110010|NCT01544361|P3|Participant Flow|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110023|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110024|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110025|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110026|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
110027|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
110028|NCT01544361|E5|Reported Event|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110029|NCT01544361|E4|Reported Event|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110030|NCT01544361|E3|Reported Event|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
110031|NCT01544361|E2|Reported Event|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
110032|NCT01544361|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
110033|NCT01544348|B9|Baseline|Total|Total of all reporting groups
110034|NCT01544348|B8|Baseline|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110035|NCT01544348|B7|Baseline|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110036|NCT01544348|B6|Baseline|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110037|NCT01544348|B5|Baseline|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110038|NCT01544348|B4|Baseline|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110039|NCT01544348|B3|Baseline|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110040|NCT01544348|B2|Baseline|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110041|NCT01544348|B1|Baseline|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110042|NCT01544348|P8|Participant Flow|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110043|NCT01544348|P7|Participant Flow|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110044|NCT01544348|P6|Participant Flow|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110045|NCT01544348|P5|Participant Flow|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110046|NCT01544348|P4|Participant Flow|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110047|NCT01544348|P3|Participant Flow|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110048|NCT01544348|P2|Participant Flow|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110049|NCT01544348|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110050|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110051|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110052|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110053|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110054|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110055|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110056|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110057|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110058|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110059|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110060|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110061|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110062|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110063|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110064|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110065|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110066|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110067|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110068|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110069|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110070|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110071|NCT01544348|O1|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110072|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110073|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110074|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110075|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110076|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110077|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110078|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110079|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110080|NCT01544348|E8|Reported Event|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
110081|NCT01544348|E7|Reported Event|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
110082|NCT01544348|E6|Reported Event|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
110083|NCT01544348|E5|Reported Event|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
110084|NCT01544348|E4|Reported Event|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
110085|NCT01544348|E3|Reported Event|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
110086|NCT01544348|E2|Reported Event|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
110087|NCT01544348|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
110088|NCT01544309|B3|Baseline|Total|Total of all reporting groups
110089|NCT01544309|B2|Baseline|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110090|NCT01544309|B1|Baseline|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110091|NCT01544309|P2|Participant Flow|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
110092|NCT01544309|P1|Participant Flow|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
110093|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110094|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110095|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110096|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110097|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110098|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110099|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110100|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110101|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110102|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110103|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110135|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110104|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110105|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110106|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110107|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110108|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110109|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110110|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110111|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110112|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110113|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110114|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110115|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110116|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110117|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110118|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110119|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110120|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110121|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110122|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110123|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110124|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110125|NCT01544309|E2|Reported Event|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
110126|NCT01544309|E1|Reported Event|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
110127|NCT01544179|B3|Baseline|Total|Total of all reporting groups
110128|NCT01544179|B2|Baseline|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110129|NCT01544179|B1|Baseline|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110130|NCT01544179|P2|Participant Flow|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110131|NCT01544179|P1|Participant Flow|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110137|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110138|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110139|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110140|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110141|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110142|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110143|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110144|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110145|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110146|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110147|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110148|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110149|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110150|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110151|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110152|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110153|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110154|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110155|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110156|NCT01544179|E2|Reported Event|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
110157|NCT01544179|E1|Reported Event|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
110158|NCT01544166|B1|Baseline|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110159|NCT01544166|P1|Participant Flow|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110160|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110161|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110162|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110163|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110164|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110165|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110166|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110167|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110168|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110169|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110170|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110171|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110172|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110173|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110174|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110175|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110176|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110177|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110178|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110179|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110180|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110181|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110182|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110183|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110184|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110185|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110186|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110337|NCT01543685|E2|Reported Event|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110187|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110188|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110189|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110190|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110191|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110192|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110193|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110194|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110195|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110196|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110197|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110198|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110199|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110200|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110201|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110202|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110203|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110204|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110205|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110206|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110207|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110208|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110209|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
110210|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
110211|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110212|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110213|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110214|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110215|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110216|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110217|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110218|NCT01544166|E1|Reported Event|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
110219|NCT01543958|B1|Baseline|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110220|NCT01543958|P1|Participant Flow|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110221|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110222|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110223|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110224|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110225|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110226|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110227|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110228|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110229|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110230|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110231|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110232|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110233|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110234|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110235|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110236|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110237|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110238|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110239|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110240|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110241|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110242|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110243|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110244|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110245|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110246|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110247|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110248|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110249|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110250|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110251|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110252|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110253|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110254|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110255|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110256|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110257|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110258|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110259|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110260|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110261|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110262|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110263|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110264|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110265|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110266|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110267|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110268|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110269|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110270|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110271|NCT01543958|E1|Reported Event|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
110272|NCT01543828|B3|Baseline|Total|Total of all reporting groups
110273|NCT01543828|B2|Baseline|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
110338|NCT01543685|E1|Reported Event|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110339|NCT01543581|B1|Baseline|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
110274|NCT01543828|B1|Baseline|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
110275|NCT01543828|P2|Participant Flow|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
110276|NCT01543828|P1|Participant Flow|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
110277|NCT01543828|O4|Outcome|placebo_treatment 2|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
110278|NCT01543828|O3|Outcome|placebo_treatment 1|In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.
110279|NCT01543828|O2|Outcome|indacaterol_treatment 2|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
110280|NCT01543828|O1|Outcome|indacaterol_treatment 1|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.
110281|NCT01543828|E2|Reported Event|Placebo|Participants received placebo one dose delivered via SDDPI.
110282|NCT01543828|E1|Reported Event|Indacaterol|Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
110283|NCT01543685|B6|Baseline|Total|Total of all reporting groups
110284|NCT01543685|B5|Baseline|Placebo|Placebo : Capsules
110285|NCT01543685|B4|Baseline|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110286|NCT01543685|B3|Baseline|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110287|NCT01543685|B2|Baseline|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110288|NCT01543685|B1|Baseline|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110289|NCT01543685|P5|Participant Flow|Placebo|Placebo : Capsules
110290|NCT01543685|P4|Participant Flow|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110291|NCT01543685|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110292|NCT01543685|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110293|NCT01543685|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110294|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110295|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110296|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110297|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110298|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110299|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110300|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110301|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110302|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110303|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110304|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110305|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110306|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110307|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110308|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110309|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110310|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110311|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110312|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110313|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110314|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110315|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110316|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110317|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110318|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110319|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110320|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110321|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110322|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110323|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110324|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110325|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110326|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110327|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110328|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110329|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
110330|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
110331|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
110332|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
110333|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110334|NCT01543685|E5|Reported Event|Placebo|Placebo : Capsules
110335|NCT01543685|E4|Reported Event|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
110340|NCT01543581|P2|Participant Flow|Inactive Placebo|Those to whom the inactive placebo is given.
110341|NCT01543581|P1|Participant Flow|Vismodegib|Those to whom the drug is given.
110342|NCT01543581|O1|Outcome|Vismodegib|Those to whom the drug is given.
110343|NCT01543581|O1|Outcome|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
110344|NCT01543581|E2|Reported Event|Inactive Placebo|Those to whom the inactive placebo is given.
110345|NCT01543581|E1|Reported Event|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
110346|NCT01543568|B1|Baseline|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110347|NCT01543568|P1|Participant Flow|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110348|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110349|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110350|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110351|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110352|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110353|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110354|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110355|NCT01543568|E1|Reported Event|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
110356|NCT01543503|B3|Baseline|Total|Total of all reporting groups
110357|NCT01543503|B2|Baseline|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110358|NCT01543503|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110359|NCT01543503|P2|Participant Flow|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110360|NCT01543503|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110361|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110362|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110363|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110364|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110365|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110366|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110367|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110368|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110369|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110370|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110371|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110372|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110373|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110374|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110375|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110376|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110377|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110378|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110379|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110380|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110381|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110382|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110383|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110384|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110385|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110386|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110387|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110388|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110389|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110390|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110391|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110392|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110393|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110394|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110395|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110396|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110397|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110398|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110399|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110400|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110401|NCT01543503|E2|Reported Event|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110402|NCT01543503|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
110403|NCT01543204|B1|Baseline|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110404|NCT01543204|P1|Participant Flow|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110405|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110406|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110407|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110408|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110409|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110410|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110411|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110412|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110413|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110414|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110415|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110416|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110417|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110418|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110419|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110420|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110421|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110422|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110423|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110424|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110425|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110426|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110427|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110428|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110429|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110430|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110431|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110432|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110433|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110434|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110435|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110436|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110437|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110438|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
110439|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110440|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110441|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110442|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110443|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110444|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
110445|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110446|NCT01543204|E1|Reported Event|Etanercept 50mg BIW/50mg QW|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
110447|NCT01543178|B4|Baseline|Total|Total of all reporting groups
110448|NCT01543178|B3|Baseline|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
110449|NCT01543178|B2|Baseline|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
110450|NCT01543178|B1|Baseline|Open-label Rifaximin Only|The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
110451|NCT01543178|P3|Participant Flow|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
110452|NCT01543178|P2|Participant Flow|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
110453|NCT01543178|P1|Participant Flow|Open-label Rifaximin|"Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.~Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo."
110454|NCT01543178|O2|Outcome|Double-blind Placebo (Retreatment)|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo."
110455|NCT01543178|O1|Outcome|Double-blind Rifaximin (Retreatment)|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin."
110540|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110456|NCT01543178|E3|Reported Event|Double-blind Retreatment Experience - Placebo Group|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo.~Double-blind experience is shown here."
110457|NCT01543178|E2|Reported Event|Double-blind Retreatment Experience - Rifaximin Group|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin.~Double-blind experience is shown here."
110458|NCT01543178|E1|Reported Event|Total Open-label Experience|"This group includes all 2579 subjects who received rifaximin the open-label period.~Open-label experience is shown here."
110459|NCT01543074|B5|Baseline|Total|Total of all reporting groups
110460|NCT01543074|B4|Baseline|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110461|NCT01543074|B3|Baseline|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
110462|NCT01543074|B2|Baseline|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110463|NCT01543074|B1|Baseline|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
110464|NCT01543074|P4|Participant Flow|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110465|NCT01543074|P3|Participant Flow|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
110466|NCT01543074|P2|Participant Flow|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110467|NCT01543074|P1|Participant Flow|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
110468|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~Garlic oil: 1 pill = 30 mg garlic oil/day~BSE: 2 pills = 200 micromoles of Sulforaphane/day"
110469|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~BSE: 2 pills = 200 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
110470|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic oil: 1 pill = 30 mg garlic oil/day"
110471|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
110472|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110473|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
110474|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110475|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
110476|NCT01543074|E4|Reported Event|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110477|NCT01543074|E3|Reported Event|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
110478|NCT01543074|E2|Reported Event|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
110479|NCT01543074|E1|Reported Event|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
110480|NCT01542957|B3|Baseline|Total|Total of all reporting groups
110481|NCT01542957|B2|Baseline|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
110482|NCT01542957|B1|Baseline|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
110483|NCT01542957|P2|Participant Flow|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
110640|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
110484|NCT01542957|P1|Participant Flow|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
110485|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
110486|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
110487|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
110488|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
110489|NCT01542957|E2|Reported Event|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
110490|NCT01542957|E1|Reported Event|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
110491|NCT01542788|B3|Baseline|Total|Total of all reporting groups
110492|NCT01542788|B2|Baseline|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110493|NCT01542788|B1|Baseline|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110494|NCT01542788|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110495|NCT01542788|P1|Participant Flow|SOF+RBV|Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110496|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110497|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110498|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110499|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110500|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110501|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110502|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110503|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110504|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110505|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110506|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110507|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110508|NCT01542788|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
110509|NCT01542788|E1|Reported Event|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
110641|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details.
110642|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
110510|NCT01542684|B1|Baseline|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
110511|NCT01542684|P1|Participant Flow|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~Granulocyte-macrophage colony-stimulating factor (GM-CSF) administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
110512|NCT01542684|O1|Outcome|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle will last at least 4 weeks~Azacytidine: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.~GM-CSF: 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days."
110513|NCT01542684|E1|Reported Event|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
110514|NCT01542645|B3|Baseline|Total|Total of all reporting groups
110515|NCT01542645|B2|Baseline|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110516|NCT01542645|B1|Baseline|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110517|NCT01542645|P2|Participant Flow|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110518|NCT01542645|P1|Participant Flow|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110519|NCT01542645|O2|Outcome|Fentanyl|
110520|NCT01542645|O1|Outcome|Methadone|
110521|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110522|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110523|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110524|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110525|NCT01542645|E2|Reported Event|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110526|NCT01542645|E1|Reported Event|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
110527|NCT01542632|B7|Baseline|Total|Total of all reporting groups
110528|NCT01542632|B6|Baseline|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110529|NCT01542632|B5|Baseline|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110530|NCT01542632|B4|Baseline|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110531|NCT01542632|B3|Baseline|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110532|NCT01542632|B2|Baseline|Group 2 (DO:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110533|NCT01542632|B1|Baseline|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110534|NCT01542632|P6|Participant Flow|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110535|NCT01542632|P5|Participant Flow|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110536|NCT01542632|P4|Participant Flow|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110537|NCT01542632|P3|Participant Flow|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110538|NCT01542632|P2|Participant Flow|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110539|NCT01542632|P1|Participant Flow|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110541|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110542|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110543|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110544|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110545|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110546|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110547|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110548|NCT01542632|O4|Outcome|Group 4 (D0:TDV,P D90:TDV,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110549|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110550|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110551|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110552|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110553|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110554|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110555|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110556|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110557|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110558|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110559|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110560|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110561|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110562|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110563|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110564|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110565|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110566|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110567|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110568|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110569|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110570|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
110571|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110572|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110643|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
110573|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.
110574|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110575|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110576|NCT01542632|E6|Reported Event|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
110577|NCT01542632|E5|Reported Event|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110578|NCT01542632|E4|Reported Event|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
110579|NCT01542632|E3|Reported Event|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
110580|NCT01542632|E2|Reported Event|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
110581|NCT01542632|E1|Reported Event|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
110582|NCT01542541|B3|Baseline|Total|Total of all reporting groups
110583|NCT01542541|B2|Baseline|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
110584|NCT01542541|B1|Baseline|Rifaximin|Rifaximin: 550mg BID for 2 days
110585|NCT01542541|P2|Participant Flow|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
110586|NCT01542541|P1|Participant Flow|Rifaximin|Rifaximin: 550mg BID for 2 days
110587|NCT01542541|O2|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
110588|NCT01542541|O1|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
110589|NCT01542541|E2|Reported Event|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
110590|NCT01542541|E1|Reported Event|Rifaximin|Rifaximin: 550mg BID for 2 days
110591|NCT01542502|B1|Baseline|All Participants|Baseline measures for all study participants
110592|NCT01542502|P2|Participant Flow|Placebo (First) Then Anakinra (Second)|"Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days~Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection"
110593|NCT01542502|P1|Participant Flow|Anakinra (First) Then Placebo (Second)|"Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days~Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection"
110594|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
110595|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra~Anakinra: Anakinra 100 mg daily subcutaneous injection"
110596|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
110597|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
110598|NCT01542502|E2|Reported Event|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
110599|NCT01542502|E1|Reported Event|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
110600|NCT01542255|B1|Baseline|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
110601|NCT01542255|P1|Participant Flow|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
110602|NCT01542255|O1|Outcome|Single Arm|
110603|NCT01542255|E1|Reported Event|Single Arm|all patients received cyclophosphamide, DTIC and vinblastine
110604|NCT01542125|B3|Baseline|Total|Total of all reporting groups
110605|NCT01542125|B2|Baseline|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
110606|NCT01542125|B1|Baseline|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
110607|NCT01542125|P2|Participant Flow|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
110608|NCT01542125|P1|Participant Flow|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
110609|NCT01542125|O2|Outcome|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
110610|NCT01542125|O1|Outcome|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
110611|NCT01542125|E2|Reported Event|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
110612|NCT01542125|E1|Reported Event|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
110613|NCT01542034|B3|Baseline|Total|Total of all reporting groups
110614|NCT01542034|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110615|NCT01542034|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110616|NCT01542034|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110617|NCT01542034|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110618|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110619|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110620|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110621|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110622|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110623|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110624|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110625|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110626|NCT01542034|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110627|NCT01542034|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
110628|NCT01541969|B3|Baseline|Total|Total of all reporting groups
110629|NCT01541969|B2|Baseline|Tinnitus Masking|see Protocol section for details
110630|NCT01541969|B1|Baseline|CR Neuromodulation|see Protocol section for details
110631|NCT01541969|P2|Participant Flow|Tinnitus Masking|"The active control group had the same ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-36 weeks).~The active comparator group received the intervention in a double-blind RCT (0-12 weeks). They received the same device as the treatment group but the sound stimulation was determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they received the verum experimental intervention."
110632|NCT01541969|P1|Participant Flow|CR Neuromodulation|"Acoustic Co-ordinated Reset (CR) Neuromodulation includes an ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-12 weeks) and for at least 4 hours daily (12-36 weeks)~The experimental arm received the intervention in a double-blind RCT (0-12 weeks), with the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they continued with the same experimental intervention."
110633|NCT01541969|O2|Outcome|Tinnitus Masking|The active comparator group were unblinded at 12 weeks and the device algorithm was reprogrammed in the same way as the experimental intervention. At 36 weeks, this group had therefore received a mixture of placebo (0-12 weeks) and active treatment (12-36 weeks).
110634|NCT01541969|O1|Outcome|CR Neuromodulation|The treatment group were unblinded at 12 weeks and then continued to receive the same experimental intervention. At 36 weeks, this group had therefore received active treatment (0-36 weeks).
110635|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
110636|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
110637|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
110638|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
110639|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
110644|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
110645|NCT01541969|E2|Reported Event|Tinnitus Masking|see Protocol section for details
110646|NCT01541969|E1|Reported Event|Acoustic CR Neuromodulation|see Protocol section for details
110647|NCT01541930|B1|Baseline|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
110648|NCT01541930|P1|Participant Flow|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
110649|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Pain evaluation on Day 14 by Visual Analogue Scale (mm) One patient was withdrawn on Day 7 by Subject's request
110650|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Pain evaluation on Day 7 by Visual Analogue Scale (mm)
110651|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Pain evaluation on Day 0 (baseline) by Visual Analogue Scale (mm)
110652|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Appearance score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
110653|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Appearance score evaluated on Day 7
110654|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Appearance score evaluated on Day 0 (baseline)
110655|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
110656|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
110657|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
110658|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
110659|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
110660|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
110661|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
110662|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
110663|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (Baseline)
110664|NCT01541930|O1|Outcome|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
110665|NCT01541930|E1|Reported Event|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
110666|NCT01541865|B1|Baseline|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110667|NCT01541865|P1|Participant Flow|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110668|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110669|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110670|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110671|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110672|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110673|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110674|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110675|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110676|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110677|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110678|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110679|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110680|NCT01541865|E1|Reported Event|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
110681|NCT01541735|B3|Baseline|Total|Total of all reporting groups
110682|NCT01541735|B2|Baseline|Placebo|Placebo of calcined magnesia, capsules
110683|NCT01541735|B1|Baseline|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110684|NCT01541735|P2|Participant Flow|Placebo|Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
110685|NCT01541735|P1|Participant Flow|Pantoprazole|The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days
110686|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
110687|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110688|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
110689|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110690|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
110691|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110692|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
110693|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110694|NCT01541735|E2|Reported Event|Placebo|Placebo of calcined magnesia, capsules
110695|NCT01541735|E1|Reported Event|Pantoprazole|The pantoprazole will be administered in 40mg capsules
110696|NCT01541644|B1|Baseline|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
110697|NCT01541644|P1|Participant Flow|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
110698|NCT01541644|O1|Outcome|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
110699|NCT01541644|E1|Reported Event|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
110700|NCT01541553|B3|Baseline|Total|Total of all reporting groups
110701|NCT01541553|B2|Baseline|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110702|NCT01541553|B1|Baseline|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110703|NCT01541553|P2|Participant Flow|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110704|NCT01541553|P1|Participant Flow|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110705|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110706|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110707|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110708|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110709|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110710|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110711|NCT01541553|E2|Reported Event|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
110712|NCT01541553|E1|Reported Event|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
110713|NCT01541397|B3|Baseline|Total|Total of all reporting groups
110714|NCT01541397|B2|Baseline|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110715|NCT01541397|B1|Baseline|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110716|NCT01541397|P2|Participant Flow|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110717|NCT01541397|P1|Participant Flow|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110718|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110719|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110720|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110721|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110722|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110723|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110724|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110725|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110726|NCT01541397|E2|Reported Event|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
110727|NCT01541397|E1|Reported Event|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
110728|NCT01541371|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
110729|NCT01541371|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator’s discretion once daily for 12 weeks.
110730|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110731|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110732|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110733|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110734|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110735|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110736|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110737|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110738|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110739|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110740|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110741|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110742|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110743|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110744|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110745|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
110746|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
110747|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
110748|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
110749|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
110750|NCT01541371|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
110751|NCT01541254|B1|Baseline|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
110752|NCT01541254|P1|Participant Flow|Single Arm|"Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)~Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)"
110753|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
110754|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
110755|NCT01541254|E1|Reported Event|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
110756|NCT01540981|B3|Baseline|Total|Total of all reporting groups
110757|NCT01540981|B2|Baseline|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
110758|NCT01540981|B1|Baseline|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
110759|NCT01540981|P2|Participant Flow|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
110760|NCT01540981|P1|Participant Flow|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
110761|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
110762|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
110763|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
110764|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
110765|NCT01540981|E2|Reported Event|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
110766|NCT01540981|E1|Reported Event|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
110767|NCT01540851|B3|Baseline|Total|Total of all reporting groups
110768|NCT01540851|B2|Baseline|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110769|NCT01540851|B1|Baseline|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110770|NCT01540851|P2|Participant Flow|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110810|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110811|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110771|NCT01540851|P1|Participant Flow|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110772|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
110773|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
110774|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
110775|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
110776|NCT01540851|O2|Outcome|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110777|NCT01540851|O1|Outcome|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110778|NCT01540851|E2|Reported Event|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110779|NCT01540851|E1|Reported Event|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
110780|NCT01540825|B12|Baseline|Total|Total of all reporting groups
110781|NCT01540825|B11|Baseline|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110782|NCT01540825|B10|Baseline|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110783|NCT01540825|B9|Baseline|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110784|NCT01540825|B8|Baseline|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110785|NCT01540825|B7|Baseline|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110786|NCT01540825|B6|Baseline|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110787|NCT01540825|B5|Baseline|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110788|NCT01540825|B4|Baseline|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110789|NCT01540825|B3|Baseline|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110790|NCT01540825|B2|Baseline|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110791|NCT01540825|B1|Baseline|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110792|NCT01540825|P11|Participant Flow|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110793|NCT01540825|P10|Participant Flow|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110794|NCT01540825|P9|Participant Flow|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110795|NCT01540825|P8|Participant Flow|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110796|NCT01540825|P7|Participant Flow|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110797|NCT01540825|P6|Participant Flow|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110798|NCT01540825|P5|Participant Flow|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110799|NCT01540825|P4|Participant Flow|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110800|NCT01540825|P3|Participant Flow|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110801|NCT01540825|P2|Participant Flow|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110802|NCT01540825|P1|Participant Flow|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110803|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110804|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110805|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110806|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110807|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110808|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110809|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110812|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110813|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110814|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110815|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110816|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110817|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110818|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110819|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110820|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110821|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110822|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110823|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110824|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110825|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110826|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110827|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110828|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110829|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110830|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110831|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110832|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110833|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110834|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110835|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110836|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110837|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110838|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110839|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110840|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110841|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110842|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110843|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110844|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110845|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110846|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110847|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110848|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110849|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110850|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110851|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110852|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110853|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110854|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110855|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110856|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110857|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110858|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110859|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110860|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110861|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110862|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110863|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
112210|NCT01534533|P1|Participant Flow|Placebo|starch in hard shell gelatine capsules
110864|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110865|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110866|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110867|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110868|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110869|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110870|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110871|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110872|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110873|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110874|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110875|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110876|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110877|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110878|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110879|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110880|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110881|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110882|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110883|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110884|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110885|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110886|NCT01540825|E11|Reported Event|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
110887|NCT01540825|E10|Reported Event|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
110888|NCT01540825|E9|Reported Event|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
110889|NCT01540825|E8|Reported Event|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
110890|NCT01540825|E7|Reported Event|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
110891|NCT01540825|E6|Reported Event|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
110892|NCT01540825|E5|Reported Event|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
110893|NCT01540825|E4|Reported Event|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
110894|NCT01540825|E3|Reported Event|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
110895|NCT01540825|E2|Reported Event|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
110896|NCT01540825|E1|Reported Event|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
110897|NCT01540487|B3|Baseline|Total|Total of all reporting groups
110898|NCT01540487|B2|Baseline|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
110899|NCT01540487|B1|Baseline|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
110900|NCT01540487|P2|Participant Flow|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
110901|NCT01540487|P1|Participant Flow|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
110902|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110903|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110904|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110905|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110906|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110907|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110908|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110909|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110910|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110911|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110912|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110913|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110914|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110915|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110916|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110917|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110918|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110919|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110920|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110921|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110922|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110923|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110924|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110925|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110926|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110927|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110928|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110929|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110930|NCT01540487|E4|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
110931|NCT01540487|E3|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
110932|NCT01540487|E2|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
110933|NCT01540487|E1|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
110934|NCT01540370|B1|Baseline|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
110935|NCT01540370|P1|Participant Flow|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
110936|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
110937|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
110938|NCT01540370|E1|Reported Event|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
110939|NCT01540266|B7|Baseline|Total|Total of all reporting groups
110940|NCT01540266|B6|Baseline|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110941|NCT01540266|B5|Baseline|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110942|NCT01540266|B4|Baseline|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110943|NCT01540266|B3|Baseline|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110944|NCT01540266|B2|Baseline|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110945|NCT01540266|B1|Baseline|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110946|NCT01540266|P6|Participant Flow|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110947|NCT01540266|P5|Participant Flow|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110948|NCT01540266|P4|Participant Flow|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110949|NCT01540266|P3|Participant Flow|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110950|NCT01540266|P2|Participant Flow|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110951|NCT01540266|P1|Participant Flow|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110952|NCT01540266|O6|Outcome|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110953|NCT01540266|O5|Outcome|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110954|NCT01540266|O4|Outcome|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110955|NCT01540266|O3|Outcome|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110956|NCT01540266|O2|Outcome|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110957|NCT01540266|O1|Outcome|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110958|NCT01540266|E6|Reported Event|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110959|NCT01540266|E5|Reported Event|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110960|NCT01540266|E4|Reported Event|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110961|NCT01540266|E3|Reported Event|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110962|NCT01540266|E2|Reported Event|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110963|NCT01540266|E1|Reported Event|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
110964|NCT01540162|B3|Baseline|Total|Total of all reporting groups
110965|NCT01540162|B2|Baseline|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
111300|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
110966|NCT01540162|B1|Baseline|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110967|NCT01540162|P2|Participant Flow|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
110968|NCT01540162|P1|Participant Flow|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110969|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
110970|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110971|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
110972|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110973|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
110974|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110975|NCT01540162|E2|Reported Event|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
110976|NCT01540162|E1|Reported Event|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
110977|NCT01540045|B1|Baseline|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
110978|NCT01540045|P1|Participant Flow|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
110979|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110980|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110981|NCT01540045|O2|Outcome|Post-chemotherapy Patients|patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
110982|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
110983|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110984|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110985|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110986|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110987|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110988|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110989|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110990|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110991|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
110992|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
110993|NCT01540045|O2|Outcome|> Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
110994|NCT01540045|O1|Outcome|< or = Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
110995|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
110996|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
110997|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
110998|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
110999|NCT01540045|O2|Outcome|HRQL Post-chemotherapy|Score of scale HRQL EORTC
111000|NCT01540045|O1|Outcome|HRQL Pre-chemotherapy|Score of scale HRQL EORTC
111001|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
111002|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
111003|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
111004|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
111005|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|patient with less sensibility to perceive sweet taste from food
111006|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|patient with more sensibility to perceive sweet taste from food
111007|NCT01540045|O2|Outcome|Post-chemotherapy Patientes|Subjective Global Assessment post chemotherapy
111008|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|Subjective Global Assessment pre-chemotherapy
111009|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body mass index post chemotherapy
111010|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body mass index pre-chemotherapty
111011|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body composition post chemotherapy
111012|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body composition pre-chemotherapy
111013|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
111014|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
111015|NCT01540045|E1|Reported Event|LUNG CANCER PATIENTS|any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
111016|NCT01539980|B1|Baseline|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111017|NCT01539980|P1|Participant Flow|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111018|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111019|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111020|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111021|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111022|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111023|NCT01539980|E1|Reported Event|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
111024|NCT01539811|B3|Baseline|Total|Total of all reporting groups
111025|NCT01539811|B2|Baseline|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
111026|NCT01539811|B1|Baseline|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
111027|NCT01539811|P2|Participant Flow|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
111028|NCT01539811|P1|Participant Flow|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
111029|NCT01539811|O2|Outcome|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
111030|NCT01539811|O1|Outcome|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
111031|NCT01539811|E2|Reported Event|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
111032|NCT01539811|E1|Reported Event|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
111033|NCT01539759|B3|Baseline|Total|Total of all reporting groups
111034|NCT01539759|B2|Baseline|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
111035|NCT01539759|B1|Baseline|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
111208|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
111036|NCT01539759|P2|Participant Flow|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
111037|NCT01539759|P1|Participant Flow|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
111038|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
111039|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
111040|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
111041|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
111042|NCT01539759|E2|Reported Event|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
111043|NCT01539759|E1|Reported Event|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
111044|NCT01539642|B3|Baseline|Total|Total of all reporting groups
111045|NCT01539642|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
111046|NCT01539642|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
111047|NCT01539642|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
111048|NCT01539642|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
111049|NCT01539642|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
111050|NCT01539642|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
111051|NCT01539642|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
111052|NCT01539642|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
111053|NCT01539590|B3|Baseline|Total|Total of all reporting groups
111054|NCT01539590|B2|Baseline|Placebo|Normal saline. Daily intravenous administration for four (4) days.
111055|NCT01539590|B1|Baseline|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
111056|NCT01539590|P2|Participant Flow|Placebo; 4 Daily Doses|Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
111057|NCT01539590|P1|Participant Flow|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
111058|NCT01539590|O2|Outcome|Placebo, 4 Daily Doses|Normal saline. Daily intravenous administration for four (4) days.
111059|NCT01539590|O1|Outcome|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
111060|NCT01539590|E2|Reported Event|Placebo|"Normal saline~Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight."
111061|NCT01539590|E1|Reported Event|BB3 Small Molecule Mimetic of Hepatocyte Growth Factor|"small molecule mimetic of hepatocyte growth factor/scatter factor~BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days"
111062|NCT01539538|B3|Baseline|Total|Total of all reporting groups
111063|NCT01539538|B2|Baseline|Morphine IV PCA|
111064|NCT01539538|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|
111065|NCT01539538|P2|Participant Flow|Morphine IV PCA|
111066|NCT01539538|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|
111067|NCT01539538|O2|Outcome|Morphine IV PCA|
111068|NCT01539538|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|
111069|NCT01539538|E2|Reported Event|Morphine IV PCA|
111070|NCT01539538|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|
111071|NCT01539512|B3|Baseline|Total|Total of all reporting groups
111072|NCT01539512|B2|Baseline|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111073|NCT01539512|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111074|NCT01539512|P2|Participant Flow|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111075|NCT01539512|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111076|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111077|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111078|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111079|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111080|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111081|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111082|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111083|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111084|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111085|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111086|NCT01539512|E2|Reported Event|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111087|NCT01539512|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
111088|NCT01539317|B3|Baseline|Total|Total of all reporting groups
111089|NCT01539317|B2|Baseline|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111090|NCT01539317|B1|Baseline|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111091|NCT01539317|P2|Participant Flow|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111092|NCT01539317|P1|Participant Flow|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111093|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111094|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111095|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111096|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111097|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111098|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111099|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111100|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111101|NCT01539317|O3|Outcome|Open Label|"During Open-label Lidocaine 8 weeks~Each prior arm converted to use of open label lidocaine for 2 further months."
111102|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
111103|NCT01539317|O1|Outcome|Topical Saline|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
111104|NCT01539317|E2|Reported Event|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111105|NCT01539317|E1|Reported Event|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
111106|NCT01539135|B3|Baseline|Total|Total of all reporting groups
111107|NCT01539135|B2|Baseline|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111108|NCT01539135|B1|Baseline|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111109|NCT01539135|P2|Participant Flow|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111209|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111110|NCT01539135|P1|Participant Flow|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111111|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111112|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111113|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111114|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111115|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111116|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111117|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111118|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111119|NCT01539135|E2|Reported Event|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111120|NCT01539135|E1|Reported Event|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
111121|NCT01539083|B1|Baseline|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
111122|NCT01539083|P3|Participant Flow|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111123|NCT01539083|P2|Participant Flow|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111124|NCT01539083|P1|Participant Flow|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
111125|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111126|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111127|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111128|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111210|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111211|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111129|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111130|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111131|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111132|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111133|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111134|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111135|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111136|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111137|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111138|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111139|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111140|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111141|NCT01539083|E3|Reported Event|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
111142|NCT01539083|E2|Reported Event|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
111143|NCT01539083|E1|Reported Event|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
111144|NCT01539070|B3|Baseline|Total|Total of all reporting groups
111145|NCT01539070|B2|Baseline|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111146|NCT01539070|B1|Baseline|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111895|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111147|NCT01539070|P2|Participant Flow|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111148|NCT01539070|P1|Participant Flow|Eating and Physical Activity Counseling|"Eating and physical activity counseling: The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111149|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111150|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111151|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111152|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111153|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111154|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111155|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111156|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111157|NCT01539070|E2|Reported Event|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
111180|NCT01537835|P2|Participant Flow|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111158|NCT01539070|E1|Reported Event|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
111159|NCT01538472|B1|Baseline|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
111160|NCT01538472|P1|Participant Flow|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (BCNU) (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
111161|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
111162|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
111163|NCT01538472|E1|Reported Event|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
111164|NCT01537900|B1|Baseline|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111165|NCT01537900|P1|Participant Flow|Grazoprevir 100 mg|Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
111166|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111167|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111168|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111169|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111170|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111171|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111172|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111173|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111174|NCT01537900|E1|Reported Event|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
111175|NCT01537835|B4|Baseline|Total|Total of all reporting groups
111176|NCT01537835|B3|Baseline|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111177|NCT01537835|B2|Baseline|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111178|NCT01537835|B1|Baseline|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
111179|NCT01537835|P3|Participant Flow|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111181|NCT01537835|P1|Participant Flow|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
111182|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111183|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111184|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
111185|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111186|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111187|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
111188|NCT01537835|E3|Reported Event|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111189|NCT01537835|E2|Reported Event|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
111190|NCT01537835|E1|Reported Event|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
111191|NCT01537666|B5|Baseline|Total|Total of all reporting groups
111192|NCT01537666|B4|Baseline|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111193|NCT01537666|B3|Baseline|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111194|NCT01537666|B2|Baseline|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111195|NCT01537666|B1|Baseline|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111196|NCT01537666|P4|Participant Flow|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111197|NCT01537666|P3|Participant Flow|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111198|NCT01537666|P2|Participant Flow|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111199|NCT01537666|P1|Participant Flow|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
111200|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111201|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111202|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111203|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111204|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
111205|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111206|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111207|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111212|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
111213|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111214|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111215|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111216|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
111217|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111218|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111219|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111220|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
111221|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111222|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111223|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
111224|NCT01537666|O6|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111225|NCT01537666|O5|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111226|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
111227|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
111228|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
111229|NCT01537666|O1|Outcome|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
111230|NCT01537666|E6|Reported Event|IV Vancomycin 250 mg in Healthy Volunteers|Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
111231|NCT01537666|E5|Reported Event|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111232|NCT01537666|E4|Reported Event|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
111233|NCT01537666|E3|Reported Event|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
111234|NCT01537666|E2|Reported Event|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
111235|NCT01537666|E1|Reported Event|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
111236|NCT01537432|B3|Baseline|Total|Total of all reporting groups
111237|NCT01537432|B2|Baseline|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
111238|NCT01537432|B1|Baseline|AIN457 300mg|AIN457 300mg subcutaneously weekly
111239|NCT01537432|P2|Participant Flow|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
111240|NCT01537432|P1|Participant Flow|AIN457 300mg|AIN457 300mg subcutaneously weekly
111241|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
111242|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
111243|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
111244|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
111245|NCT01537432|E2|Reported Event|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
111246|NCT01537432|E1|Reported Event|AIN457 300 mg|AIN457 300mg subcutaneously weekly
111247|NCT01537367|B4|Baseline|Total|Total of all reporting groups
111248|NCT01537367|B3|Baseline|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111249|NCT01537367|B2|Baseline|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111250|NCT01537367|B1|Baseline|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
111267|NCT01537315|B2|Baseline|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
111251|NCT01537367|P3|Participant Flow|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111252|NCT01537367|P2|Participant Flow|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111253|NCT01537367|P1|Participant Flow|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
111254|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111255|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111256|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
111257|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111258|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111259|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
111260|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111261|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111262|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
111263|NCT01537367|E3|Reported Event|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
111264|NCT01537367|E2|Reported Event|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
111265|NCT01537367|E1|Reported Event|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
111266|NCT01537315|B3|Baseline|Total|Total of all reporting groups
111268|NCT01537315|B1|Baseline|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
111269|NCT01537315|P2|Participant Flow|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
111270|NCT01537315|P1|Participant Flow|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
111271|NCT01537315|O2|Outcome|Hydroxychloroquine|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or matching placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
111272|NCT01537315|O1|Outcome|Matching Placebo|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
111273|NCT01537315|E2|Reported Event|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
111274|NCT01537315|E1|Reported Event|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
111275|NCT01537302|B1|Baseline|Ocelot|CTO crossing in femoropopliteal arteries using the Ocelot System
111276|NCT01537302|P1|Participant Flow|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
111277|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
111278|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
111279|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
111280|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
111281|NCT01537302|E1|Reported Event|Treatment Arm|CTO crossing in femoropopliteal arteries CONNECT II: CTO crossing in femoropopliteal arteries using the Ocelot System
111282|NCT01537198|B1|Baseline|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
111283|NCT01537198|P1|Participant Flow|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
111284|NCT01537198|O1|Outcome|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
111285|NCT01537198|E1|Reported Event|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
111286|NCT01537185|B5|Baseline|Total|Total of all reporting groups
111287|NCT01537185|B4|Baseline|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111288|NCT01537185|B3|Baseline|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111289|NCT01537185|B2|Baseline|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
111290|NCT01537185|B1|Baseline|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111291|NCT01537185|P4|Participant Flow|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
111292|NCT01537185|P3|Participant Flow|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
111293|NCT01537185|P2|Participant Flow|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
111294|NCT01537185|P1|Participant Flow|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111295|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111296|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111297|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
111298|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111299|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
111301|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
111302|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111303|NCT01537185|E4|Reported Event|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111304|NCT01537185|E3|Reported Event|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111305|NCT01537185|E2|Reported Event|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
111306|NCT01537185|E1|Reported Event|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
111307|NCT01537133|B5|Baseline|Total|Total of all reporting groups
111308|NCT01537133|B4|Baseline|Healthy Control|
111309|NCT01537133|B3|Baseline|Atopic Non-asthmatics|
111310|NCT01537133|B2|Baseline|Atopic Asthmatics Treated With Placebo|Placebo fluticasone (one puff, twice a day)
111311|NCT01537133|B1|Baseline|Atopic Asthmatics Treated With Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
111312|NCT01537133|P4|Participant Flow|Atopic Non-asthmatics|
111313|NCT01537133|P3|Participant Flow|Healthy Control|
111314|NCT01537133|P2|Participant Flow|Placebo|Placebo fluticasone (one puff, twice a day)
111315|NCT01537133|P1|Participant Flow|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
111316|NCT01537133|O4|Outcome|Healthy Control|
111317|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
111318|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
111319|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
111320|NCT01537133|O4|Outcome|Healthy Control|
111321|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
111322|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
111323|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
111324|NCT01537133|O4|Outcome|Healthy Control|
111325|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
111326|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
111327|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
111328|NCT01537133|E2|Reported Event|Placebo|Placebo fluticasone (one puff, twice a day)
111329|NCT01537133|E1|Reported Event|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
111330|NCT01537120|B1|Baseline|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
111331|NCT01537120|P1|Participant Flow|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
111332|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
111333|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
111334|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
111335|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
111336|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
111337|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
111338|NCT01537120|E2|Reported Event|Placebo|Placebo tablets twice daily for 3 weeks
111339|NCT01537120|E1|Reported Event|Vildagliptin 50 mg|Vildagliptin tablets 50 mg twice daily for 12 weeks
111340|NCT01537081|B4|Baseline|Total|Total of all reporting groups
111341|NCT01537081|B3|Baseline|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
111342|NCT01537081|B2|Baseline|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
111343|NCT01537081|B1|Baseline|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
111344|NCT01537081|P3|Participant Flow|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
111345|NCT01537081|P2|Participant Flow|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
111346|NCT01537081|P1|Participant Flow|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
111347|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
111983|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111348|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
111349|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
111350|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
111351|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
111352|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
111353|NCT01537081|E3|Reported Event|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
111354|NCT01537081|E2|Reported Event|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
111355|NCT01537081|E1|Reported Event|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
111356|NCT01537042|B3|Baseline|Total|Total of all reporting groups
111357|NCT01537042|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111358|NCT01537042|B1|Baseline|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111359|NCT01537042|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
111360|NCT01537042|P1|Participant Flow|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance.~Up to 3 weeks of Titration,~2 weeks of Maintenance,~Up to 4 days of Taper Period."
111361|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111362|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111363|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111364|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111365|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111366|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111367|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111368|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111369|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111370|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111371|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111372|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111373|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111415|NCT01536886|P2|Participant Flow|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
111374|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111375|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111376|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111377|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111378|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111379|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111380|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111381|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111382|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111383|NCT01537042|O4|Outcome|Rotigotine (Visit 6)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111384|NCT01537042|O3|Outcome|Placebo (Visit 6)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111385|NCT01537042|O2|Outcome|Rotigotine (Visit 2)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111386|NCT01537042|O1|Outcome|Placebo (Visit 2)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111387|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111388|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111389|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111390|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111391|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111392|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111393|NCT01537042|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
111394|NCT01537042|E1|Reported Event|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
111395|NCT01536938|B4|Baseline|Total|Total of all reporting groups
111396|NCT01536938|B3|Baseline|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
111397|NCT01536938|B2|Baseline|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111398|NCT01536938|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111399|NCT01536938|P3|Participant Flow|Calcipotriol Aerosol Foam|"Calcipotriol aerosol foam: calcipotriol 50 mcg/g.~Applied once daily for up to 4 weeks"
111400|NCT01536938|P2|Participant Flow|Betamethasone Dipropionate|"Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
111401|NCT01536938|P1|Participant Flow|LEO 90100|"LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
111402|NCT01536938|O3|Outcome|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
111403|NCT01536938|O2|Outcome|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111404|NCT01536938|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111405|NCT01536938|E3|Reported Event|Calcipotriol Aerosol Foam|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111406|NCT01536938|E2|Reported Event|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111407|NCT01536938|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
111408|NCT01536886|B5|Baseline|Total|Total of all reporting groups
111409|NCT01536886|B4|Baseline|Ointment Vehicle|Ointment with no active ingredients
111410|NCT01536886|B3|Baseline|LEO 90100 Vehicle|Aerosol foam with no active ingredients
111411|NCT01536886|B2|Baseline|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
111412|NCT01536886|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
111413|NCT01536886|P4|Participant Flow|Ointment Vehicle|Ointment with no active ingredients
111414|NCT01536886|P3|Participant Flow|LEO 90100 Vehicle|Aerosol foam with no active ingredients
111416|NCT01536886|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
111417|NCT01536886|O4|Outcome|Ointment Vehicle|Ointment with no active ingredients
111418|NCT01536886|O3|Outcome|LEO 90100 Vehicle|Aerosol foam with no active ingredients
111419|NCT01536886|O2|Outcome|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
111420|NCT01536886|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
111421|NCT01536886|E4|Reported Event|Ointment Vehicle|Ointment with no active ingredients
111422|NCT01536886|E3|Reported Event|LEO 90100 Vehicle|Aerosol foam with no active ingredients
111423|NCT01536886|E2|Reported Event|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
111424|NCT01536886|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
111425|NCT01536860|B1|Baseline|Entire Study Population|Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
111426|NCT01536860|P3|Participant Flow|Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1|"Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 once over a 15 minute period."
111427|NCT01536860|P2|Participant Flow|Exp Test Drink 1/Control Test Drink/Exp Test Drink 2|"Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 2 once over a 15 minute period."
111428|NCT01536860|P1|Participant Flow|Control Test Drink/Exp Test Drink 1/Exp Test Drink 2|"Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period"
111429|NCT01536860|O3|Outcome|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
111430|NCT01536860|O2|Outcome|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
111431|NCT01536860|O1|Outcome|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
111432|NCT01536860|E3|Reported Event|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
111433|NCT01536860|E2|Reported Event|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
111434|NCT01536860|E1|Reported Event|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
111435|NCT01536704|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
111436|NCT01536704|P4|Participant Flow|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111437|NCT01536704|P3|Participant Flow|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111438|NCT01536704|P2|Participant Flow|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111439|NCT01536704|P1|Participant Flow|2 Milligram (mg) Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111440|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111441|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111442|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111443|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111444|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111445|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111446|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111447|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111448|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111449|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111450|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111451|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111452|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111453|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111454|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111455|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111456|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111457|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111458|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111459|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111460|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111461|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111462|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111463|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111464|NCT01536704|E4|Reported Event|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111465|NCT01536704|E3|Reported Event|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
111466|NCT01536704|E2|Reported Event|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111467|NCT01536704|E1|Reported Event|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
111468|NCT01536587|B1|Baseline|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111469|NCT01536587|P1|Participant Flow|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111470|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111471|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111472|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111473|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111474|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111475|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111476|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111477|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111478|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111479|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111480|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111481|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111482|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111483|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111484|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111485|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111486|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111487|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111488|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111489|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111490|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111491|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111492|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111493|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111494|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111495|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111496|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111497|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111498|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111499|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111500|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111501|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111502|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111503|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111504|NCT01536587|E1|Reported Event|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
111505|NCT01536574|B3|Baseline|Total|Total of all reporting groups
111506|NCT01536574|B2|Baseline|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111507|NCT01536574|B1|Baseline|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111508|NCT01536574|P2|Participant Flow|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111509|NCT01536574|P1|Participant Flow|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111510|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111634|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111984|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111511|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111512|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111513|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111514|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111515|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111516|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111517|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111518|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111635|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111636|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111985|NCT01535599|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111519|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111520|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111521|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111522|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111523|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111524|NCT01536574|E2|Reported Event|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111525|NCT01536574|E1|Reported Event|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
111526|NCT01536561|B1|Baseline|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111637|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111638|NCT01536405|E2|Reported Event|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111527|NCT01536561|P1|Participant Flow|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111528|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111529|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111530|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111531|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111532|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111533|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111639|NCT01536405|E1|Reported Event|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111640|NCT01536366|B3|Baseline|Total|Total of all reporting groups
111641|NCT01536366|B2|Baseline|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
111534|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111535|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111536|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111537|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111538|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111539|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111540|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111642|NCT01536366|B1|Baseline|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
111643|NCT01536366|P2|Participant Flow|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
111986|NCT01535599|E1|Reported Event|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111541|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111542|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111543|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111544|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111545|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111546|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111547|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111644|NCT01536366|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
111645|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
111646|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
111647|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
111648|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
111548|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111549|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111550|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111551|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111552|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111553|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111554|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111649|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
111650|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
111651|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
111652|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
111653|NCT01536366|E2|Reported Event|Repaglinide|Repaglinide 0.5 mg
111654|NCT01536366|E1|Reported Event|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
111555|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
111556|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111557|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111558|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111559|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111560|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
111561|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111655|NCT01536262|B4|Baseline|Total|Total of all reporting groups
111656|NCT01536262|B3|Baseline|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111657|NCT01536262|B2|Baseline|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111562|NCT01536561|E2|Reported Event|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:&gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
111563|NCT01536561|E1|Reported Event|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
111564|NCT01536496|B3|Baseline|Total|Total of all reporting groups
111565|NCT01536496|B2|Baseline|Test (r-TEG)|
111566|NCT01536496|B1|Baseline|Control (INR, PTT, Fibrinogen, D-dimer)|
111567|NCT01536496|P2|Participant Flow|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111568|NCT01536496|P1|Participant Flow|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111569|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111570|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111571|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111658|NCT01536262|B1|Baseline|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111987|NCT01535560|B3|Baseline|Total|Total of all reporting groups
111572|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111573|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111574|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111575|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111576|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111577|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111578|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111659|NCT01536262|P3|Participant Flow|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111660|NCT01536262|P2|Participant Flow|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111661|NCT01536262|P1|Participant Flow|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111579|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111580|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111581|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111582|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111583|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111584|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111585|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111662|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111663|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111664|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111586|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111587|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111588|NCT01536496|O1|Outcome|Control (INR, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111589|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111590|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111591|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111592|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111665|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111666|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111667|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111593|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111594|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111595|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111596|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111597|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111598|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111599|NCT01536496|E2|Reported Event|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
111668|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111669|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111670|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111600|NCT01536496|E1|Reported Event|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
111601|NCT01536405|B3|Baseline|Total|Total of all reporting groups
111602|NCT01536405|B2|Baseline|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111603|NCT01536405|B1|Baseline|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111604|NCT01536405|P2|Participant Flow|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111605|NCT01536405|P1|Participant Flow|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111606|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111607|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111608|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111609|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111610|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111611|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111612|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111613|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111614|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111615|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111616|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111617|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111618|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111619|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111620|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111621|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111622|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111623|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111624|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111625|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111626|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111627|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111628|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111629|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111630|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111631|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111632|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
111633|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
111671|NCT01536262|E3|Reported Event|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111672|NCT01536262|E2|Reported Event|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111673|NCT01536262|E1|Reported Event|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
111674|NCT01536197|B3|Baseline|Total|Total of all reporting groups
111675|NCT01536197|B2|Baseline|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
111676|NCT01536197|B1|Baseline|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
111677|NCT01536197|P2|Participant Flow|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
111678|NCT01536197|P1|Participant Flow|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
111679|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
111680|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
111681|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
111682|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
111683|NCT01536197|E2|Reported Event|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
111684|NCT01536197|E1|Reported Event|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
111685|NCT01536184|B3|Baseline|Total|Total of all reporting groups
111686|NCT01536184|B2|Baseline|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111687|NCT01536184|B1|Baseline|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111688|NCT01536184|P2|Participant Flow|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111689|NCT01536184|P1|Participant Flow|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111690|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111691|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111692|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111709|NCT01536145|P10|Participant Flow|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111710|NCT01536145|P9|Participant Flow|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111711|NCT01536145|P8|Participant Flow|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111988|NCT01535560|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111693|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111694|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111695|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111696|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111697|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111698|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111699|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111700|NCT01536184|E2|Reported Event|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
111701|NCT01536184|E1|Reported Event|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
111702|NCT01536171|B1|Baseline|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
111703|NCT01536171|P1|Participant Flow|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
111704|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|two running conditions, with normal running shoes and barefoot
111705|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
111706|NCT01536171|E1|Reported Event|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
111707|NCT01536145|B1|Baseline|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111708|NCT01536145|P11|Participant Flow|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111712|NCT01536145|P7|Participant Flow|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111713|NCT01536145|P6|Participant Flow|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111714|NCT01536145|P5|Participant Flow|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111715|NCT01536145|P4|Participant Flow|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111716|NCT01536145|P3|Participant Flow|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111717|NCT01536145|P2|Participant Flow|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111718|NCT01536145|P1|Participant Flow|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111719|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111720|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111721|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111722|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111723|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111724|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111725|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111726|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111727|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111728|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111729|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111730|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111731|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111732|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111733|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111734|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111735|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111736|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111737|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111738|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111739|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111893|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111740|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111741|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111742|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111743|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111744|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111745|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111746|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111747|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111748|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111749|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111750|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111751|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111752|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111753|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111754|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111755|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111756|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111757|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111758|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111759|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111760|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111761|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111762|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111763|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111764|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111765|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111766|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111989|NCT01535560|B1|Baseline|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
111767|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111768|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111769|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111770|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111771|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111772|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111773|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111774|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111775|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111776|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111777|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111778|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111779|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111780|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111781|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111782|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111783|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111784|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111785|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111786|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111787|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111788|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111789|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111790|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111791|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111792|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111793|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111794|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111795|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
113000|NCT01530243|B1|Baseline|Placebo|Placebo: same as tolterodine and terazosin dose
111796|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111797|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111798|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111799|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111800|NCT01536145|O9|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111801|NCT01536145|O8|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111802|NCT01536145|O7|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111803|NCT01536145|O6|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111804|NCT01536145|O5|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111805|NCT01536145|O4|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111806|NCT01536145|O3|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111807|NCT01536145|O2|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111808|NCT01536145|O1|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111809|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111810|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111811|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111812|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
111813|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111814|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111815|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111816|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111817|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111818|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111819|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
111820|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
111821|NCT01536145|E1|Reported Event|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
111822|NCT01536119|B3|Baseline|Total|Total of all reporting groups
111823|NCT01536119|B2|Baseline|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111990|NCT01535560|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111824|NCT01536119|B1|Baseline|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111825|NCT01536119|P2|Participant Flow|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111826|NCT01536119|P1|Participant Flow|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111827|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111828|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111829|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111830|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111831|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111832|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111833|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111834|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111835|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111836|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111837|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111838|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111839|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111840|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111841|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111842|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111843|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111844|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111845|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111846|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111847|NCT01536119|E2|Reported Event|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
111848|NCT01536119|E1|Reported Event|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
111849|NCT01536093|B3|Baseline|Total|Total of all reporting groups
111850|NCT01536093|B2|Baseline|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111851|NCT01536093|B1|Baseline|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111852|NCT01536093|P2|Participant Flow|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111853|NCT01536093|P1|Participant Flow|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111854|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111855|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111991|NCT01535560|P1|Participant Flow|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
111856|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111857|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111858|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111859|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111860|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111861|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111862|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111863|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111864|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111865|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111866|NCT01536093|E2|Reported Event|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111867|NCT01536093|E1|Reported Event|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
111868|NCT01536067|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111869|NCT01536067|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111870|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111871|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111872|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111894|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
113004|NCT01530243|P1|Participant Flow|Placebo|Placebo: same as tolterodine and terazosin dose
111873|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111874|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111875|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111876|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111877|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111878|NCT01536067|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
111879|NCT01536015|B3|Baseline|Total|Total of all reporting groups
111880|NCT01536015|B2|Baseline|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111881|NCT01536015|B1|Baseline|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111882|NCT01536015|P2|Participant Flow|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111883|NCT01536015|P1|Participant Flow|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111884|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111885|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111886|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111887|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111888|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111889|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111890|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111891|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111892|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111896|NCT01536015|E2|Reported Event|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
111897|NCT01536015|E1|Reported Event|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
111898|NCT01535976|B3|Baseline|Total|Total of all reporting groups
111899|NCT01535976|B2|Baseline|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
111900|NCT01535976|B1|Baseline|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min"
111901|NCT01535976|P2|Participant Flow|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
111902|NCT01535976|P1|Participant Flow|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
111903|NCT01535976|O2|Outcome|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
111904|NCT01535976|O1|Outcome|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min."
111905|NCT01535976|E2|Reported Event|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
111906|NCT01535976|E1|Reported Event|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
111907|NCT01535807|B3|Baseline|Total|Total of all reporting groups
111908|NCT01535807|B2|Baseline|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111909|NCT01535807|B1|Baseline|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111910|NCT01535807|P2|Participant Flow|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111911|NCT01535807|P1|Participant Flow|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111912|NCT01535807|O2|Outcome|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111913|NCT01535807|O1|Outcome|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111914|NCT01535807|E2|Reported Event|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111915|NCT01535807|E1|Reported Event|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
111916|NCT01535729|B1|Baseline|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111917|NCT01535729|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC) Elderly Participants|Elderly Participants (greater than or equal to [≥] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111918|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111919|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111920|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111921|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111922|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111923|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111924|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111925|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111926|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111927|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111928|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111929|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111930|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111931|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111932|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111933|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111934|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111935|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111936|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111937|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111938|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111939|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111940|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111941|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111942|NCT01535729|E1|Reported Event|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
111943|NCT01535664|B1|Baseline|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111944|NCT01535664|P1|Participant Flow|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111945|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111946|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
111947|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111948|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
111949|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111950|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
111992|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111951|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111952|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
111953|NCT01535664|O2|Outcome|Dalfampridine-ER 10 mg|
111954|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111955|NCT01535664|E2|Reported Event|Dalfampridine-ER Withdrawn|
111956|NCT01535664|E1|Reported Event|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
111957|NCT01535638|B1|Baseline|All Subjects|This study was conducted in healthy male subjects as open-label, single-dose, randomised three-way crossover trial to investigate relative bioavailability. Each subject was planned to receive all 3 treatments in a randomly assigned order. The treatments were 3 single doses of 600 mg (3 film-coated tablets à 200 mg each) of Deleobuvir, either as TF II (trial formulation 2) formulation, FF (final formulation) formulation or as FF modified formulation.
111958|NCT01535638|P6|Participant Flow|Final Formulation (FF) Modified / FF / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Final Formulation and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
111959|NCT01535638|P5|Participant Flow|Final Formulation (FF) Modified / Trial Formulation II / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Trial Formulation II and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
111960|NCT01535638|P4|Participant Flow|Final Formulation (FF) / FF Modified / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Final Formulation modified and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
111961|NCT01535638|P3|Participant Flow|Final Formulation (FF) / Trial Formulation II / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Trial Formulation II and Final Formulation modified. There was a wash out period of at least 6 days between each drug administration.
111962|NCT01535638|P2|Participant Flow|Trial Formulation II / Final Formulation (FF) Modified / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation II, Final Formulation modified and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
111963|NCT01535638|P1|Participant Flow|Trial Formulation II / Final Formulation (FF) / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation (TF) II, Final Formulation (FF) and FF modified. There was a wash out period of at least 6 days between each drug administration.
111964|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111965|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111966|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111967|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111968|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111969|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111970|NCT01535638|E4|Reported Event|Deleobuvir (Total)|All subjects while on treatment with Deleobuvir, i.e. there is no distinction between the 3 formulations.
111971|NCT01535638|E3|Reported Event|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111972|NCT01535638|E2|Reported Event|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111973|NCT01535638|E1|Reported Event|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
111974|NCT01535599|B3|Baseline|Total|Total of all reporting groups
111975|NCT01535599|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111976|NCT01535599|B1|Baseline|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111977|NCT01535599|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111978|NCT01535599|P1|Participant Flow|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111979|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111980|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111981|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
111982|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
111993|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
111994|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111995|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
111996|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111997|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
111998|NCT01535560|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
111999|NCT01535560|E1|Reported Event|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
112000|NCT01535365|B3|Baseline|Total|Total of all reporting groups
112001|NCT01535365|B2|Baseline|Cold|Application of cold to muscle sprain.
112002|NCT01535365|B1|Baseline|Heat|Application of Heat to site of muscle sprain.
112003|NCT01535365|P2|Participant Flow|Cold|Application of cold to muscle sprain.
112004|NCT01535365|P1|Participant Flow|Heat|Application of Heat to site of muscle sprain.
112005|NCT01535365|O2|Outcome|Cold|Application of cold to muscle sprain.
112006|NCT01535365|O1|Outcome|Heat|Application of heat to site of muscle sprain.
112007|NCT01535365|O2|Outcome|Ice Pack|Application of cold to muscle sprain.
112008|NCT01535365|O1|Outcome|Heat Pack|Application of Heat to site of muscle sprain.
112009|NCT01535365|E2|Reported Event|Cold|Application of cold to muscle sprain.
112010|NCT01535365|E1|Reported Event|Heat|Application of Heat to site of muscle sprain.
112011|NCT01535326|B4|Baseline|Total|Total of all reporting groups
112012|NCT01535326|B3|Baseline|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112013|NCT01535326|B2|Baseline|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112014|NCT01535326|B1|Baseline|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112015|NCT01535326|P3|Participant Flow|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112016|NCT01535326|P2|Participant Flow|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112017|NCT01535326|P1|Participant Flow|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112018|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112019|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112020|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112021|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112022|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112023|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112024|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112025|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112026|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112027|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy~Proportion of no pain: 61.1%"
112028|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal~Proportion of no pain: 43.3%"
112029|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy~Proportion of no pain: 30%"
112030|NCT01535326|E3|Reported Event|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
112031|NCT01535326|E2|Reported Event|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
112032|NCT01535326|E1|Reported Event|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
112033|NCT01535261|B1|Baseline|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112034|NCT01535261|P1|Participant Flow|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112035|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112036|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112037|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112038|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112039|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112040|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112041|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112042|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112043|NCT01535261|E1|Reported Event|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
112044|NCT01535235|B3|Baseline|Total|Total of all reporting groups
112045|NCT01535235|B2|Baseline|Placebo|"Placebo group~Placebo: Placebo Daily x24wks"
112046|NCT01535235|B1|Baseline|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg Daily x 24 weeks"
112047|NCT01535235|P2|Participant Flow|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
112048|NCT01535235|P1|Participant Flow|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
112049|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
112050|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
112051|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
112052|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
112053|NCT01535235|E2|Reported Event|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
112054|NCT01535235|E1|Reported Event|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
112055|NCT01535222|B7|Baseline|Total|Total of all reporting groups
112056|NCT01535222|B6|Baseline|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
112057|NCT01535222|B5|Baseline|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
112058|NCT01535222|B4|Baseline|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
112059|NCT01535222|B3|Baseline|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
112060|NCT01535222|B2|Baseline|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
112061|NCT01535222|B1|Baseline|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
112062|NCT01535222|P6|Participant Flow|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
112063|NCT01535222|P5|Participant Flow|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
112064|NCT01535222|P4|Participant Flow|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
112065|NCT01535222|P3|Participant Flow|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
112066|NCT01535222|P2|Participant Flow|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
112067|NCT01535222|P1|Participant Flow|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
112068|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
112069|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
112070|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
112071|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
112072|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
112073|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
112074|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
112075|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
112076|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
112077|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
112078|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
112079|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
112080|NCT01535222|E6|Reported Event|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
112081|NCT01535222|E5|Reported Event|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
112082|NCT01535222|E4|Reported Event|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
112083|NCT01535222|E3|Reported Event|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
112084|NCT01535222|E2|Reported Event|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
112085|NCT01535222|E1|Reported Event|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
112086|NCT01535118|B1|Baseline|Adults and Children With ARC|Adults and children with ARC who complete the survey
112087|NCT01535118|P1|Participant Flow|Adults and Children With Allergic Rhinoconjunctivitis (ARC)|Adults and children with ARC who complete the survey
112088|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112089|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112090|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112091|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112092|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112093|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
112094|NCT01535118|E1|Reported Event|Adults and Children With ARC|Adults and children with ARC who complete the survey
112095|NCT01535040|B3|Baseline|Total|Total of all reporting groups
112096|NCT01535040|B2|Baseline|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112154|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
113005|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
112097|NCT01535040|B1|Baseline|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112098|NCT01535040|P2|Participant Flow|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112099|NCT01535040|P1|Participant Flow|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112100|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112101|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112102|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112103|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112104|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112105|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112106|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112107|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112108|NCT01535040|E2|Reported Event|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
112109|NCT01535040|E1|Reported Event|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
112110|NCT01535001|B3|Baseline|Total|Total of all reporting groups
112111|NCT01535001|B2|Baseline|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112112|NCT01535001|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112113|NCT01535001|P2|Participant Flow|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112114|NCT01535001|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112115|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112155|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112156|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112157|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112158|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112211|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
112116|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112117|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112118|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112119|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112120|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112121|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112122|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112123|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112124|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112125|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112126|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112127|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112159|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112128|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112129|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112130|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112131|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112132|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112133|NCT01535001|E2|Reported Event|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
112134|NCT01535001|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
112135|NCT01534962|B5|Baseline|Total|Total of all reporting groups
112136|NCT01534962|B4|Baseline|Placebo|Placebo, oral, BID.
112137|NCT01534962|B3|Baseline|Ranolazin High Dose|Ranolazine, high dose, oral, BID
112138|NCT01534962|B2|Baseline|Ranolazine Intermediate Dose|Ranolazine, intermediate dose, oral, BID
112139|NCT01534962|B1|Baseline|Ranolazine Low Dose|Ranolazine, low dose, oral, BID
112140|NCT01534962|P4|Participant Flow|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112141|NCT01534962|P3|Participant Flow|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112142|NCT01534962|P2|Participant Flow|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112143|NCT01534962|P1|Participant Flow|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112144|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112145|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112146|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112147|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112148|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112149|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112150|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112151|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112152|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112153|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112160|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112161|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112162|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112163|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112164|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112165|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112166|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112167|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112168|NCT01534962|E4|Reported Event|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
112169|NCT01534962|E3|Reported Event|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112170|NCT01534962|E2|Reported Event|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112171|NCT01534962|E1|Reported Event|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
112172|NCT01534910|B3|Baseline|Total|Total of all reporting groups
112173|NCT01534910|B2|Baseline|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract"
112174|NCT01534910|B1|Baseline|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo"
112175|NCT01534910|P2|Participant Flow|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
112176|NCT01534910|P1|Participant Flow|Sugar Pill|"placebo~placebo: placebo"
112177|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
112178|NCT01534910|O1|Outcome|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
112179|NCT01534910|E2|Reported Event|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
112180|NCT01534910|E1|Reported Event|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
112181|NCT01534689|B1|Baseline|Erchonia FX-405™ Laser|"The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW~Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time."
112182|NCT01534689|P1|Participant Flow|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
112183|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
112184|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
112185|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
112186|NCT01534689|E1|Reported Event|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
112187|NCT01534676|B3|Baseline|Total|Total of all reporting groups
112188|NCT01534676|B2|Baseline|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
112189|NCT01534676|B1|Baseline|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
112190|NCT01534676|P2|Participant Flow|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
112208|NCT01534533|P3|Participant Flow|Lutein and Lycopene Group|lutein plus lycopene group
112191|NCT01534676|P1|Participant Flow|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
112192|NCT01534676|O2|Outcome|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
112193|NCT01534676|O1|Outcome|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
112194|NCT01534676|E2|Reported Event|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
112195|NCT01534676|E1|Reported Event|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
112196|NCT01534637|B1|Baseline|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112197|NCT01534637|P1|Participant Flow|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112198|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112199|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112200|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112201|NCT01534637|E1|Reported Event|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
112202|NCT01534533|B5|Baseline|Total|Total of all reporting groups
112203|NCT01534533|B4|Baseline|Normal Lutein Group|subjects without early atherosclerosis
112204|NCT01534533|B3|Baseline|Lutein and Lycopene Group|lutein plus lycopene group
112205|NCT01534533|B2|Baseline|Lutein Group|20mg lutein per day
112206|NCT01534533|B1|Baseline|Placebo|starch in hard shell gelatine capsules
112207|NCT01534533|P4|Participant Flow|Normal Lutein Group|subjects without early atherosclerosis
112212|NCT01534533|O3|Outcome|Combination Group (LL Group)|early atherosclerosis cases received 20mg lutein and 20mg lycopene
112213|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
112214|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
112215|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
112216|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
112217|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
112218|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
112219|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
112220|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
112221|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
112222|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
112223|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
112224|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
112225|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
112226|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
112227|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
112228|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
112229|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
112230|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
112231|NCT01534533|E4|Reported Event|Normal Lutein Control Group|20mg lutein for subjects free from atherosclerosis, once a day
112232|NCT01534533|E3|Reported Event|Combination Group|early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
112233|NCT01534533|E2|Reported Event|Lutein Group|early atherosclerosis cases, received 20mg lutein, once a day
112234|NCT01534533|E1|Reported Event|Placebo|early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
112235|NCT01534520|B3|Baseline|Total|Total of all reporting groups
112236|NCT01534520|B2|Baseline|Group 2: Intravaginal Placebo Gel|4mL placebo gel (K-Y Jelly) for vaginal self-administration
112237|NCT01534520|B1|Baseline|Group 1: Intravaginal 2% Lidocaine Gel|"4mL of 2% lidocaine gel for vaginal self-administration~)"
112238|NCT01534520|P2|Participant Flow|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
112239|NCT01534520|P1|Participant Flow|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
112240|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
112241|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
112242|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Placebo: KY Jelly"
112243|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
112244|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
112245|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
112246|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
112247|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
112248|NCT01534520|E2|Reported Event|Study Drug|"Intravaginal insertion of 4mL 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
112249|NCT01534520|E1|Reported Event|Placebo|"Intravaginal insertion of 4mL placebo gel~Placebo: KY Jelly"
112250|NCT01534351|B4|Baseline|Total|Total of all reporting groups
112251|NCT01534351|B3|Baseline|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112252|NCT01534351|B2|Baseline|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112253|NCT01534351|B1|Baseline|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112254|NCT01534351|P3|Participant Flow|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112255|NCT01534351|P2|Participant Flow|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112256|NCT01534351|P1|Participant Flow|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112257|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112258|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112259|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112260|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112261|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112262|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112263|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112264|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112265|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112266|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112267|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112268|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112269|NCT01534351|E3|Reported Event|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112270|NCT01534351|E2|Reported Event|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112271|NCT01534351|E1|Reported Event|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
112272|NCT01534208|B3|Baseline|Total|Total of all reporting groups
112273|NCT01534208|B2|Baseline|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112274|NCT01534208|B1|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112275|NCT01534208|P2|Participant Flow|Androxal 25 mg|"Androxal 25 mg daily~Androxal, oral, 25 mg capsule, taken once daily"
112276|NCT01534208|P1|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal, oral, 12.5 mg capsule, taken once daily"
112277|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112278|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112279|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112280|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112281|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112282|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112283|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112284|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112285|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112286|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112287|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112325|NCT01533974|B3|Baseline|Total|Total of all reporting groups
112288|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112289|NCT01534208|E2|Reported Event|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112290|NCT01534208|E1|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
112291|NCT01534182|B3|Baseline|Total|Total of all reporting groups
112292|NCT01534182|B2|Baseline|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112293|NCT01534182|B1|Baseline|Fingolimod|Participants received 0.5 mg orally once a day.
112294|NCT01534182|P2|Participant Flow|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112295|NCT01534182|P1|Participant Flow|Fingolimod|Participants received 0.5 mg orally once a day.
112296|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112297|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
112298|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112299|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
112300|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112301|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
112302|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112303|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
112304|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
112305|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
112306|NCT01534182|E3|Reported Event|Standard Disease Modifying Therapy: Glatiramer Acetate|Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
112307|NCT01534182|E2|Reported Event|Standard Disease Modifying Therapy (DMT): Interferon Beta-1a|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week
112308|NCT01534182|E1|Reported Event|Fingolimod|Participants received 0.5 mg orally once a day.
112309|NCT01534143|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112310|NCT01534143|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112311|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112312|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112313|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112326|NCT01533974|B2|Baseline|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
112350|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112314|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112315|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112316|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112317|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112318|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112319|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112320|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112321|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112322|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112323|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112324|NCT01534143|E1|Reported Event|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
112327|NCT01533974|B1|Baseline|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
112328|NCT01533974|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
112329|NCT01533974|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
112330|NCT01533974|O2|Outcome|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
112331|NCT01533974|O1|Outcome|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
112332|NCT01533974|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
112333|NCT01533974|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
112334|NCT01533935|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:~Oral inhalation of placebo~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
112335|NCT01533935|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
112336|NCT01533935|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
112337|NCT01533935|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
112338|NCT01533935|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
112339|NCT01533935|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
112340|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112341|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112342|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112343|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112344|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112345|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112346|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112347|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112348|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112349|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112351|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112352|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112353|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112354|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112355|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112356|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112357|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112358|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112359|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112360|NCT01533935|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112361|NCT01533935|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112362|NCT01533935|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112363|NCT01533935|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112364|NCT01533935|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112365|NCT01533922|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Olodaterol fixed dose 5 µg~Tiotropium fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
112366|NCT01533922|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
112367|NCT01533922|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
112368|NCT01533922|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
112369|NCT01533922|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
112370|NCT01533922|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
112371|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112372|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112373|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112374|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112375|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112449|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112376|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112377|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112378|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112379|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112380|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112381|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112382|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112383|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112384|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112385|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112386|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112387|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112388|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112389|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112390|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112391|NCT01533922|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112392|NCT01533922|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112393|NCT01533922|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112394|NCT01533922|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
112395|NCT01533922|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
112396|NCT01533753|B3|Baseline|Total|Total of all reporting groups
112397|NCT01533753|B2|Baseline|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112398|NCT01533753|B1|Baseline|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112399|NCT01533753|P2|Participant Flow|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112400|NCT01533753|P1|Participant Flow|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112401|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112450|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112402|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112403|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112404|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112405|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112406|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112407|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112408|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112409|NCT01533753|E2|Reported Event|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
112410|NCT01533753|E1|Reported Event|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
112411|NCT01533597|B3|Baseline|Total|Total of all reporting groups
112412|NCT01533597|B2|Baseline|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112413|NCT01533597|B1|Baseline|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112414|NCT01533597|P2|Participant Flow|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112415|NCT01533597|P1|Participant Flow|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112416|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112417|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112418|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112419|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112420|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112421|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112422|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112423|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112424|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112425|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112426|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112427|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112428|NCT01533597|E2|Reported Event|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
112429|NCT01533597|E1|Reported Event|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
112430|NCT01533493|B3|Baseline|Total|Total of all reporting groups
112431|NCT01533493|B2|Baseline|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112432|NCT01533493|B1|Baseline|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112433|NCT01533493|P2|Participant Flow|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112434|NCT01533493|P1|Participant Flow|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112435|NCT01533493|O2|Outcome|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112436|NCT01533493|O1|Outcome|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112437|NCT01533493|E2|Reported Event|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112438|NCT01533493|E1|Reported Event|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
112439|NCT01533428|B3|Baseline|Total|Total of all reporting groups
112440|NCT01533428|B2|Baseline|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112441|NCT01533428|B1|Baseline|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112442|NCT01533428|P2|Participant Flow|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112443|NCT01533428|P1|Participant Flow|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112444|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112445|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112446|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112447|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112448|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112451|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112452|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112453|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112454|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112455|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112456|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112457|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112458|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112459|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112460|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112461|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112462|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112463|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112464|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112465|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112466|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112467|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112468|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112469|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112470|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112471|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112472|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112473|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112474|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112475|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112476|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112477|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112478|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112479|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112480|NCT01533428|E2|Reported Event|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
112481|NCT01533428|E1|Reported Event|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
112482|NCT01533259|B1|Baseline|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
112483|NCT01533259|P1|Participant Flow|Stribild|Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
112484|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
112485|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
112486|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
112487|NCT01533259|E1|Reported Event|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
112488|NCT01533246|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112489|NCT01533246|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112490|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112491|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112492|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112493|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112494|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112495|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112496|NCT01533246|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
112497|NCT01533181|B3|Baseline|Total|Total of all reporting groups
112498|NCT01533181|B2|Baseline|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112499|NCT01533181|B1|Baseline|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112500|NCT01533181|P2|Participant Flow|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112501|NCT01533181|P1|Participant Flow|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112502|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112503|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112504|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112505|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112506|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112507|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112508|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112509|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112510|NCT01533181|E2|Reported Event|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
112511|NCT01533181|E1|Reported Event|Arm A: Topotocan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
112512|NCT01533116|B5|Baseline|Total|Total of all reporting groups
112513|NCT01533116|B4|Baseline|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112514|NCT01533116|B3|Baseline|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112515|NCT01533116|B2|Baseline|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112516|NCT01533116|B1|Baseline|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112517|NCT01533116|P4|Participant Flow|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112518|NCT01533116|P3|Participant Flow|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112519|NCT01533116|P2|Participant Flow|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112520|NCT01533116|P1|Participant Flow|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112521|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112522|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112523|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112524|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112525|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112526|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112527|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112528|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112529|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112530|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112531|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112532|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112533|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112534|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112535|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112536|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112537|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112538|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112539|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112540|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112541|NCT01533116|E4|Reported Event|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112542|NCT01533116|E3|Reported Event|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112543|NCT01533116|E2|Reported Event|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
112544|NCT01533116|E1|Reported Event|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
112545|NCT01533077|B5|Baseline|Total|Total of all reporting groups
112546|NCT01533077|B4|Baseline|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112547|NCT01533077|B3|Baseline|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112548|NCT01533077|B2|Baseline|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112549|NCT01533077|B1|Baseline|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112550|NCT01533077|P4|Participant Flow|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112551|NCT01533077|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112552|NCT01533077|P2|Participant Flow|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112553|NCT01533077|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
112554|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112555|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112556|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
112557|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112558|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112559|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
112560|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112561|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112562|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
112563|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112564|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112565|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
112566|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112567|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112568|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112569|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112570|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112571|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112572|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112573|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112574|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112575|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112576|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112577|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112578|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112579|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112580|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112581|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112582|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112583|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112584|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112585|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112586|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112587|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112588|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112589|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112590|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112591|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112592|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112593|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112594|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112595|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112596|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112597|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112598|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
113006|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
112599|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112600|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
112601|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
112602|NCT01533077|E4|Reported Event|Sinemet® 100/25 mg|Sinemet® 100/25 mg.
112603|NCT01533077|E3|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly.
112604|NCT01533077|E2|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h.
112605|NCT01533077|E1|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg.
112606|NCT01533038|B3|Baseline|Total|Total of all reporting groups
112607|NCT01533038|B2|Baseline|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
112608|NCT01533038|B1|Baseline|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
112609|NCT01533038|P2|Participant Flow|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
112610|NCT01533038|P1|Participant Flow|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
112611|NCT01533038|O2|Outcome|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
112612|NCT01533038|O1|Outcome|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
112613|NCT01533038|E2|Reported Event|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
112614|NCT01533038|E1|Reported Event|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
112615|NCT01532999|B3|Baseline|Total|Total of all reporting groups
112616|NCT01532999|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112680|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
112681|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112682|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112617|NCT01532999|B1|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112618|NCT01532999|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112619|NCT01532999|P1|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112620|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112621|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112622|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112623|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112624|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112625|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112626|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112627|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112683|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112684|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
113001|NCT01530243|P4|Participant Flow|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
112628|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112629|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112630|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112631|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112632|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112633|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112634|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112635|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112636|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112637|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112638|NCT01532999|E2|Reported Event|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
112685|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112686|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112639|NCT01532999|E1|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
112640|NCT01532973|B10|Baseline|Total|Total of all reporting groups
112641|NCT01532973|B9|Baseline|Placebo|Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
112642|NCT01532973|B8|Baseline|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
112643|NCT01532973|B7|Baseline|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
112644|NCT01532973|B6|Baseline|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
112645|NCT01532973|B5|Baseline|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
112646|NCT01532973|B4|Baseline|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
112647|NCT01532973|B3|Baseline|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
112648|NCT01532973|B2|Baseline|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
112649|NCT01532973|B1|Baseline|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
112650|NCT01532973|P10|Participant Flow|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112651|NCT01532973|P9|Participant Flow|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112652|NCT01532973|P8|Participant Flow|GT3 HCV 200-mg Elbasvir (Panel H)|Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112653|NCT01532973|P7|Participant Flow|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112654|NCT01532973|P6|Participant Flow|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112655|NCT01532973|P5|Participant Flow|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112656|NCT01532973|P4|Participant Flow|GT1 HCV 200-mg Elbasvir (Panel D)|Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112657|NCT01532973|P3|Participant Flow|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112658|NCT01532973|P2|Participant Flow|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112659|NCT01532973|P1|Participant Flow|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112660|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112661|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
112662|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
112663|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
112664|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
112665|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
112666|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
112667|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
112668|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
112669|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
112670|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112671|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112672|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
112673|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112674|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112675|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112676|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112677|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112678|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112679|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112687|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
112688|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
112689|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112690|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
112691|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
112692|NCT01532973|E6|Reported Event|Post-Study|All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
112693|NCT01532973|E5|Reported Event|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
112694|NCT01532973|E4|Reported Event|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
112695|NCT01532973|E3|Reported Event|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
112696|NCT01532973|E2|Reported Event|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
112697|NCT01532973|E1|Reported Event|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
112698|NCT01532934|B3|Baseline|Total|Total of all reporting groups
112699|NCT01532934|B2|Baseline|Standard Care (SC)|Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
112700|NCT01532934|B1|Baseline|Brief Motivational Intervention Plus Standard Care (BMI+SC)|Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
112701|NCT01532934|P2|Participant Flow|Standard Care|"standard care~standard care: standard care"
112702|NCT01532934|P1|Participant Flow|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
112703|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
112704|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
112705|NCT01532934|O2|Outcome|Standard Care|"standard care~standard care: standard care"
112706|NCT01532934|O1|Outcome|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
112707|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
112708|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
112709|NCT01532934|E2|Reported Event|Standard Care|There were no adverse events for members of this group.
112710|NCT01532934|E1|Reported Event|Brief Motivational Intervention Plus Standard Care|There were no adverse events for members of this group.
112711|NCT01532869|B3|Baseline|Total|Total of all reporting groups
112712|NCT01532869|B2|Baseline|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112713|NCT01532869|B1|Baseline|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112714|NCT01532869|P2|Participant Flow|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112715|NCT01532869|P1|Participant Flow|Placebo|Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for Week 48 to Week 96.
112716|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112717|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112718|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112719|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112720|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112721|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112722|NCT01532869|O1|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112723|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112724|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112725|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112726|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112727|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112728|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112729|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112730|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112731|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112732|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112733|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112734|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112735|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112736|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112737|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112738|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112739|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112740|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112741|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112742|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112743|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
112744|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
112745|NCT01532869|E6|Reported Event|Tocilizumab to Tocilizumab (up to 96 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
112746|NCT01532869|E5|Reported Event|Placebo to Tocilizumab (up to 96 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
112747|NCT01532869|E4|Reported Event|Tocilizumab (up to 48 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
112748|NCT01532869|E3|Reported Event|Placebo (up to 48 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
112749|NCT01532869|E2|Reported Event|Tocilizumab (up to 24 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
112750|NCT01532869|E1|Reported Event|Placebo (up to 24 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
112751|NCT01532635|B1|Baseline|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112752|NCT01532635|P1|Participant Flow|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112753|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112754|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112755|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112756|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112757|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112758|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112759|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112760|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112761|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112762|NCT01532635|E1|Reported Event|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
112763|NCT01532570|B5|Baseline|Total|Total of all reporting groups
112764|NCT01532570|B4|Baseline|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112765|NCT01532570|B3|Baseline|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112766|NCT01532570|B2|Baseline|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112767|NCT01532570|B1|Baseline|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112768|NCT01532570|P4|Participant Flow|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112769|NCT01532570|P3|Participant Flow|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112770|NCT01532570|P2|Participant Flow|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112771|NCT01532570|P1|Participant Flow|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112772|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112773|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
112774|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
112775|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
112776|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112777|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
112778|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
112779|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
112780|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient 2)|
112781|NCT01532570|O1|Outcome|Acute Neuro BD (Patient 1)|
112782|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112783|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112784|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112785|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112786|NCT01532570|O1|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112787|NCT01532570|O1|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112788|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112789|NCT01532570|O3|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112790|NCT01532570|O2|Outcome|Neuro-BD (Acute+Chronic Progressive)|"Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.~Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30."
112791|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112792|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112793|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112794|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112795|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112796|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112797|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112798|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112799|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112800|NCT01532570|E1|Reported Event|TA-650|TA-650: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
112801|NCT01532453|B3|Baseline|Total|Total of all reporting groups
112802|NCT01532453|B2|Baseline|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
112803|NCT01532453|B1|Baseline|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
112804|NCT01532453|P2|Participant Flow|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
112805|NCT01532453|P1|Participant Flow|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
112806|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
112807|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
112808|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
112809|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
112899|NCT01531387|E2|Reported Event|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112810|NCT01532453|E2|Reported Event|MD-3511356|"Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).~MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun."
112811|NCT01532453|E1|Reported Event|Standard Sun Protection Measures|"Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).~Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product."
112812|NCT01532414|B4|Baseline|Total|Total of all reporting groups
112813|NCT01532414|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
112814|NCT01532414|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112815|NCT01532414|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
112816|NCT01532414|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
112817|NCT01532414|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112818|NCT01532414|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
112819|NCT01532414|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
112820|NCT01532414|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112821|NCT01532414|O1|Outcome|Androxal Treated Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112822|NCT01532414|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
112823|NCT01532414|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112824|NCT01532414|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
112825|NCT01532362|B3|Baseline|Total|Total of all reporting groups
112826|NCT01532362|B2|Baseline|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112827|NCT01532362|B1|Baseline|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112828|NCT01532362|P2|Participant Flow|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112829|NCT01532362|P1|Participant Flow|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112830|NCT01532362|O2|Outcome|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112831|NCT01532362|O1|Outcome|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112832|NCT01532362|E2|Reported Event|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112833|NCT01532362|E1|Reported Event|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
112834|NCT01532141|B4|Baseline|Total|Total of all reporting groups
112835|NCT01532141|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112836|NCT01532141|B2|Baseline|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112837|NCT01532141|B1|Baseline|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112838|NCT01532141|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112839|NCT01532141|P2|Participant Flow|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112840|NCT01532141|P1|Participant Flow|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
112841|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
112842|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
112843|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
112844|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
112845|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
112846|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
112847|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
112848|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
112849|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
112850|NCT01532141|E4|Reported Event|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
112851|NCT01532141|E3|Reported Event|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
112852|NCT01532141|E2|Reported Event|BIA 9-1067 Alone|BIA 9-1067 alone.
112853|NCT01532141|E1|Reported Event|Before Treatment|Before treatment.
112854|NCT01532128|B4|Baseline|Total|Total of all reporting groups
112855|NCT01532128|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112856|NCT01532128|B2|Baseline|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112857|NCT01532128|B1|Baseline|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112858|NCT01532128|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112859|NCT01532128|P2|Participant Flow|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112860|NCT01532128|P1|Participant Flow|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
112861|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
112862|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
112863|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
112864|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
112865|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
112866|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
112867|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
112868|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
112869|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
112870|NCT01532128|E4|Reported Event|Rasagiline Concomitant BIA 9-1067|
112871|NCT01532128|E3|Reported Event|Rasagiline 1 h After BIA 9-1067|
112872|NCT01532128|E2|Reported Event|Rasagiline Alone|
112873|NCT01532128|E1|Reported Event|Before Treatment|
112874|NCT01531998|B1|Baseline|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
112875|NCT01531998|P1|Participant Flow|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
112876|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
112877|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
112878|NCT01531998|E1|Reported Event|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
112879|NCT01531725|B1|Baseline|BMS Implantation|Patients with a BMS implanted.
112880|NCT01531725|P1|Participant Flow|BMS Implantation|BMS implantation
112881|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
112882|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
112883|NCT01531725|E1|Reported Event|BMS Implantation|BMS implantation
112884|NCT01531387|B3|Baseline|Total|Total of all reporting groups
112885|NCT01531387|B2|Baseline|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112886|NCT01531387|B1|Baseline|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112887|NCT01531387|P2|Participant Flow|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112888|NCT01531387|P1|Participant Flow|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112889|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112890|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112891|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112892|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112893|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112894|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112895|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112896|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112897|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
112898|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
113002|NCT01530243|P3|Participant Flow|Tolterodine|Tolterodine: 2 mg daily
112900|NCT01531387|E1|Reported Event|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
112901|NCT01531335|B3|Baseline|Total|Total of all reporting groups
112902|NCT01531335|B2|Baseline|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
112903|NCT01531335|B1|Baseline|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
112904|NCT01531335|P2|Participant Flow|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
112905|NCT01531335|P1|Participant Flow|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
112906|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
112907|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
112908|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
112909|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
112910|NCT01531335|E2|Reported Event|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
112911|NCT01531335|E1|Reported Event|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
112912|NCT01531205|B1|Baseline|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112913|NCT01531205|P1|Participant Flow|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112914|NCT01531205|O2|Outcome|Participant Two|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112915|NCT01531205|O1|Outcome|Participant One|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112916|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112917|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112918|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112919|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112920|NCT01531205|E1|Reported Event|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
112921|NCT01530477|B4|Baseline|Total|Total of all reporting groups
112922|NCT01530477|B3|Baseline|Skeletal and Body Composition|"Skeletal and Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
112923|NCT01530477|B2|Baseline|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
112924|NCT01530477|B1|Baseline|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
112925|NCT01530477|P3|Participant Flow|Skeletal & Body Composition|"Skeletal & Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
112964|NCT01530399|B5|Baseline|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
112926|NCT01530477|P2|Participant Flow|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
112927|NCT01530477|P1|Participant Flow|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
112928|NCT01530477|O2|Outcome|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
112929|NCT01530477|O1|Outcome|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
112930|NCT01530477|E2|Reported Event|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
112931|NCT01530477|E1|Reported Event|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
112932|NCT01530464|B3|Baseline|Total|Total of all reporting groups
112933|NCT01530464|B2|Baseline|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
112934|NCT01530464|B1|Baseline|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
112935|NCT01530464|P2|Participant Flow|Sequence B|Period 1: First intervention (Ambrisentan 5mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Aminophylline 500mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
112936|NCT01530464|P1|Participant Flow|Sequence A|Period 1: First intervention (Aminophylline 500mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Ambrisentan 5mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
112937|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
112938|NCT01530464|O3|Outcome|Ambrisentan Alone|
112939|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
112940|NCT01530464|O1|Outcome|Aminophylline Alone|
112941|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
112942|NCT01530464|O3|Outcome|Ambrisentan Alone|
112943|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
112944|NCT01530464|O1|Outcome|Aminophylline Alone|
112945|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
112946|NCT01530464|O3|Outcome|Ambrisentan Alone|
112947|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
112948|NCT01530464|O1|Outcome|Aminophylline Alone|
112949|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
112950|NCT01530464|O3|Outcome|Ambrisentan Alone|
112951|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
112952|NCT01530464|O1|Outcome|Aminophylline Alone|
112953|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
112954|NCT01530464|O3|Outcome|Ambrisentan Alone|
112955|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
112956|NCT01530464|O1|Outcome|Aminophylline Alone|
112957|NCT01530464|O2|Outcome|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
112958|NCT01530464|O1|Outcome|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
112959|NCT01530464|E3|Reported Event|Combined Aminophylline and Ambrisentan|Combined single doses of Aminophylline 400 mg and ambrisentan 5 mg, followed by a 48 h washout period
112960|NCT01530464|E2|Reported Event|Ambrisentan Only|Ambrisentan 5 mg orally, followed by 48 h washout period. lowed by 48 h washout period.
112961|NCT01530464|E1|Reported Event|Aminophylline Only|Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
112962|NCT01530399|B7|Baseline|Total|Total of all reporting groups
112963|NCT01530399|B6|Baseline|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
112996|NCT01530243|B5|Baseline|Total|Total of all reporting groups
112997|NCT01530243|B4|Baseline|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
112965|NCT01530399|B4|Baseline|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
112966|NCT01530399|B3|Baseline|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
112967|NCT01530399|B2|Baseline|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
112968|NCT01530399|B1|Baseline|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
112969|NCT01530399|P6|Participant Flow|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
112970|NCT01530399|P5|Participant Flow|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
112971|NCT01530399|P4|Participant Flow|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
112972|NCT01530399|P3|Participant Flow|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
112973|NCT01530399|P2|Participant Flow|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
112974|NCT01530399|P1|Participant Flow|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
112975|NCT01530399|O6|Outcome|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
112976|NCT01530399|O5|Outcome|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
112977|NCT01530399|O4|Outcome|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
112978|NCT01530399|O3|Outcome|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
112979|NCT01530399|O2|Outcome|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
112980|NCT01530399|O1|Outcome|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
112981|NCT01530399|E6|Reported Event|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
112982|NCT01530399|E5|Reported Event|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
112983|NCT01530399|E4|Reported Event|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
112984|NCT01530399|E3|Reported Event|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
112985|NCT01530399|E2|Reported Event|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
112986|NCT01530399|E1|Reported Event|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
112987|NCT01530334|B1|Baseline|Gefitinib|250 mg/die, oral
112988|NCT01530334|P1|Participant Flow|Gefitinib|250 mg/die, oral
112989|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112990|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112991|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112992|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112993|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112994|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
112995|NCT01530334|E1|Reported Event|Gefitinib|250 mg/die, oral
113008|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
113009|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
113010|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
113011|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
113012|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
113013|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
113014|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
113015|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
113016|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
113017|NCT01530243|E4|Reported Event|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
113018|NCT01530243|E3|Reported Event|Tolterodine|Tolterodine: 2 mg daily
113019|NCT01530243|E2|Reported Event|Terazosin|Terazosin: 2 mg BID
113020|NCT01530243|E1|Reported Event|Placebo|Placebo: same as tolterodine and terazosin dose
113021|NCT01530087|B1|Baseline|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
113022|NCT01530087|P1|Participant Flow|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
113023|NCT01530087|O1|Outcome|Treatment|"CASTLE Barrier~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
113024|NCT01530087|O1|Outcome|Treatment|CASTLE Barrier: Prototype barrier used in place of previous two piece device
113025|NCT01530087|E1|Reported Event|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
113026|NCT01529645|B11|Baseline|Total|Total of all reporting groups
113027|NCT01529645|B10|Baseline|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113028|NCT01529645|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113029|NCT01529645|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113030|NCT01529645|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113031|NCT01529645|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113032|NCT01529645|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113033|NCT01529645|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113034|NCT01529645|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113035|NCT01529645|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113036|NCT01529645|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113037|NCT01529645|P10|Participant Flow|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113038|NCT01529645|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113039|NCT01529645|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113040|NCT01529645|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113041|NCT01529645|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113042|NCT01529645|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113043|NCT01529645|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
113044|NCT01529645|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113045|NCT01529645|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113046|NCT01529645|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113047|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113142|NCT01529632|B2|Baseline|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113048|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113049|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113050|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113051|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113052|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113053|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113054|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113055|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113056|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113057|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113058|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113059|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113060|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113061|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
113062|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113063|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113064|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113065|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
113066|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113067|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113068|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113069|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113070|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113071|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113072|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113073|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113074|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113075|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113076|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113077|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113078|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113143|NCT01529632|B1|Baseline|QVA149|QVA149 plus placebo once daily for 28 days.
113079|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113080|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113081|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113082|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113083|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113084|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113085|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113086|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113087|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113088|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113089|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113090|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113091|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113092|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113093|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113094|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113095|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113096|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113097|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113098|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113099|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113100|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113101|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113102|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113103|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
113104|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113105|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113106|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113107|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
113108|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113109|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113110|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113111|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113112|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113113|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113114|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113115|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113116|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113117|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113118|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113119|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113120|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113121|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113122|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113123|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113124|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113125|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113126|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113127|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113128|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113129|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113130|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113131|NCT01529645|E10|Reported Event|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
113132|NCT01529645|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113133|NCT01529645|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113134|NCT01529645|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113135|NCT01529645|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113136|NCT01529645|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113137|NCT01529645|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
113138|NCT01529645|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
113139|NCT01529645|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
113140|NCT01529645|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
113141|NCT01529632|B3|Baseline|Total|Total of all reporting groups
113144|NCT01529632|P2|Participant Flow|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113145|NCT01529632|P1|Participant Flow|QVA149|QVA149 plus placebo once daily for 28 days.
113146|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113147|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113148|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113149|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113150|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113151|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113152|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113153|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113154|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113155|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113156|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113157|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113158|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113159|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
113160|NCT01529632|E2|Reported Event|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
113161|NCT01529632|E1|Reported Event|QVA149|QVA149 plus placebo once daily for 28 days.
113162|NCT01529515|B3|Baseline|Total|Total of all reporting groups
113163|NCT01529515|B2|Baseline|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113164|NCT01529515|B1|Baseline|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113165|NCT01529515|P4|Participant Flow|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113166|NCT01529515|P3|Participant Flow|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113167|NCT01529515|P2|Participant Flow|Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
113168|NCT01529515|P1|Participant Flow|Open-Label Transition Phase: Paliperidone Palmitate 1-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
113169|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113170|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113171|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113172|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113173|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113174|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113175|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113176|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113177|NCT01529515|E3|Reported Event|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
113602|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113178|NCT01529515|E2|Reported Event|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
113179|NCT01529515|E1|Reported Event|Open-Label Phase: PP1M + PP3M|PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
113180|NCT01529450|B3|Baseline|Total|Total of all reporting groups
113181|NCT01529450|B2|Baseline|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113182|NCT01529450|B1|Baseline|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113183|NCT01529450|P2|Participant Flow|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113184|NCT01529450|P1|Participant Flow|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113185|NCT01529450|O1|Outcome|All Participants|Participants received LDE225: 800-mg (4 200-mg capsules/day) capsule
113186|NCT01529450|O2|Outcome|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113187|NCT01529450|O1|Outcome|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113188|NCT01529450|E2|Reported Event|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113189|NCT01529450|E1|Reported Event|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
113190|NCT01529385|B3|Baseline|Total|Total of all reporting groups
113191|NCT01529385|B2|Baseline|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113192|NCT01529385|B1|Baseline|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113193|NCT01529385|P2|Participant Flow|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113194|NCT01529385|P1|Participant Flow|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113195|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113196|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113197|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113198|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113199|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113200|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113201|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113202|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113203|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113204|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113205|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113235|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113206|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113207|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113208|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113209|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113210|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113211|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113212|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113213|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113214|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113215|NCT01529385|E2|Reported Event|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
113216|NCT01529385|E1|Reported Event|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
113217|NCT01529203|B1|Baseline|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113218|NCT01529203|P1|Participant Flow|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113219|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113220|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113221|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113222|NCT01529203|E1|Reported Event|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
113223|NCT01529112|B3|Baseline|Total|Total of all reporting groups
113224|NCT01529112|B2|Baseline|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113225|NCT01529112|B1|Baseline|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113226|NCT01529112|P2|Participant Flow|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113227|NCT01529112|P1|Participant Flow|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113228|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113229|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113230|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113231|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113232|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113233|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113234|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113236|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113237|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113238|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113239|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113240|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113241|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113242|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113243|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113244|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113245|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113246|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113247|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113248|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113249|NCT01529112|E2|Reported Event|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
113250|NCT01529112|E1|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
113251|NCT01528969|B3|Baseline|Total|Total of all reporting groups
113252|NCT01528969|B2|Baseline|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
113253|NCT01528969|B1|Baseline|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
113254|NCT01528969|P2|Participant Flow|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks."
113255|NCT01528969|P1|Participant Flow|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks."
113256|NCT01528969|O2|Outcome|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
113257|NCT01528969|O1|Outcome|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
113258|NCT01528969|E2|Reported Event|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.~None of the subjects had any adverse effects of the consumption of the chewing gum."
113259|NCT01528969|E1|Reported Event|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.~None of the subjects had any adverse effects of the consumption of the chewing gum."
113260|NCT01528891|B3|Baseline|Total|Total of all reporting groups
113261|NCT01528891|B2|Baseline|Placebo|"Normal saline equivalent volume~Placebo~Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
113262|NCT01528891|B1|Baseline|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery~Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
113263|NCT01528891|P2|Participant Flow|Placebo|"Normal saline equivalent volume~Placebo"
113264|NCT01528891|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
113265|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
113266|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
113267|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
113268|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
113269|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
113270|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
113271|NCT01528891|O2|Outcome|Placebo|"Normal saline~Placebo"
113272|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery"
113273|NCT01528891|E2|Reported Event|Placebo|"Normal saline equivalent volume~Placebo"
113274|NCT01528891|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
113275|NCT01528735|B3|Baseline|Total|Total of all reporting groups
113418|NCT01528345|B2|Baseline|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113276|NCT01528735|B2|Baseline|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113277|NCT01528735|B1|Baseline|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113278|NCT01528735|P2|Participant Flow|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113279|NCT01528735|P1|Participant Flow|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113280|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113281|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113282|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113283|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113284|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113285|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113286|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113287|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113288|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113289|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113290|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113291|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113407|NCT01528605|E6|Reported Event|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
113419|NCT01528345|B1|Baseline|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113292|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113293|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113294|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113295|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113296|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113297|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113298|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113299|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113300|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113301|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113302|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113303|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113304|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113305|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113306|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113307|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113408|NCT01528605|E5|Reported Event|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
113409|NCT01528605|E4|Reported Event|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113308|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113309|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113310|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113311|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113312|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113313|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113314|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113315|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113316|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113317|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113318|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113319|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113320|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113321|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113322|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113323|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113410|NCT01528605|E3|Reported Event|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113411|NCT01528605|E2|Reported Event|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113324|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113325|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113326|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113327|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113328|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113329|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113330|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113331|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113332|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113333|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113334|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113335|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113336|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113337|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113338|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113339|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113412|NCT01528605|E1|Reported Event|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113413|NCT01528592|B1|Baseline|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
113340|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113341|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113342|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113343|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113344|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113345|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113346|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113347|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113348|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113349|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113350|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113351|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113352|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113353|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113354|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113355|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113414|NCT01528592|P1|Participant Flow|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
113415|NCT01528592|O1|Outcome|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
113356|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113357|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113358|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113359|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113360|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113361|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113362|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113363|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113364|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113365|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113366|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113367|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113368|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113369|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113370|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113371|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113416|NCT01528592|E1|Reported Event|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
113417|NCT01528345|B3|Baseline|Total|Total of all reporting groups
113603|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113372|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113373|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
113374|NCT01528735|E4|Reported Event|Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
113375|NCT01528735|E3|Reported Event|Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
113376|NCT01528735|E2|Reported Event|Faldap/Del/RBV:120mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
113377|NCT01528735|E1|Reported Event|Faldap/Del/RBV:80mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
113378|NCT01528605|B7|Baseline|Total|Total of all reporting groups
113379|NCT01528605|B6|Baseline|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
113380|NCT01528605|B5|Baseline|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
113381|NCT01528605|B4|Baseline|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113382|NCT01528605|B3|Baseline|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113383|NCT01528605|B2|Baseline|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113384|NCT01528605|B1|Baseline|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113385|NCT01528605|P6|Participant Flow|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
113386|NCT01528605|P5|Participant Flow|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
113387|NCT01528605|P4|Participant Flow|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113388|NCT01528605|P3|Participant Flow|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113389|NCT01528605|P2|Participant Flow|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113390|NCT01528605|P1|Participant Flow|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113391|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
113392|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
113393|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113394|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113395|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113396|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113397|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113398|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113399|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113400|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113401|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
113402|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
113403|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
113404|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
113405|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
113406|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
113420|NCT01528345|P2|Participant Flow|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113421|NCT01528345|P1|Participant Flow|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113422|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113423|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113424|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113425|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113426|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113427|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113428|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113429|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113430|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113431|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113432|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113433|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113434|NCT01528345|E2|Reported Event|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
113435|NCT01528345|E1|Reported Event|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
113436|NCT01528332|B3|Baseline|Total|Total of all reporting groups
113437|NCT01528332|B2|Baseline|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
113438|NCT01528332|B1|Baseline|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
113439|NCT01528332|P2|Participant Flow|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
113440|NCT01528332|P1|Participant Flow|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
113441|NCT01528332|O2|Outcome|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
113442|NCT01528332|O1|Outcome|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
113443|NCT01528332|E2|Reported Event|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
113444|NCT01528332|E1|Reported Event|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
113445|NCT01528319|B1|Baseline|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113446|NCT01528319|P1|Participant Flow|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113447|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113448|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113449|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113450|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113451|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113452|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113453|NCT01528319|E1|Reported Event|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
113454|NCT01528293|B3|Baseline|Total|Total of all reporting groups
113455|NCT01528293|B2|Baseline|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113456|NCT01528293|B1|Baseline|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113489|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113604|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113457|NCT01528293|P2|Participant Flow|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113458|NCT01528293|P1|Participant Flow|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113459|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113460|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113461|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113462|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113463|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113464|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113605|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113465|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113466|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113467|NCT01528293|E2|Reported Event|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113468|NCT01528293|E1|Reported Event|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
113469|NCT01528215|B3|Baseline|Total|Total of all reporting groups
113470|NCT01528215|B2|Baseline|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
113471|NCT01528215|B1|Baseline|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
113472|NCT01528215|P2|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
113473|NCT01528215|P1|Participant Flow|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
113474|NCT01528215|O2|Outcome|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
113475|NCT01528215|O1|Outcome|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
113476|NCT01528215|E2|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
113477|NCT01528215|E1|Reported Event|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
113478|NCT01528150|B1|Baseline|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
113479|NCT01528150|P1|Participant Flow|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
113480|NCT01528150|O1|Outcome|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
113481|NCT01528150|E1|Reported Event|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
113482|NCT01527942|B3|Baseline|Total|Total of all reporting groups
113483|NCT01527942|B2|Baseline|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113484|NCT01527942|B1|Baseline|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113485|NCT01527942|P2|Participant Flow|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113486|NCT01527942|P1|Participant Flow|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113487|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113488|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113524|NCT01527370|P1|Participant Flow|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113490|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113491|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113492|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113493|NCT01527942|E2|Reported Event|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
113494|NCT01527942|E1|Reported Event|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
113495|NCT01527513|B3|Baseline|Total|Total of all reporting groups
113496|NCT01527513|B2|Baseline|Placebo|Placebo QD
113497|NCT01527513|B1|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
113498|NCT01527513|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
113499|NCT01527513|P1|Participant Flow|Placebo|Placebo Once-Daily (QD)
113500|NCT01527513|O1|Outcome|Esl PART II|Eslicarbazepine acetate (ESL) 10-30 mg/kg/day QD (maximum 1200 mg/day).
113501|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
113502|NCT01527513|O1|Outcome|Placebo|Placebo QD
113503|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
113504|NCT01527513|O1|Outcome|Placebo|Placebo QD
113505|NCT01527513|E3|Reported Event|Part II - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
113506|NCT01527513|E2|Reported Event|Part I - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
113507|NCT01527513|E1|Reported Event|Placebo|Placebo QD
113508|NCT01527487|B3|Baseline|Total|Total of all reporting groups
113509|NCT01527487|B2|Baseline|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
113510|NCT01527487|B1|Baseline|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
113511|NCT01527487|P2|Participant Flow|Docetaxel+Cyclophosphamide: TC|"Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.~Administered every 21 days for 6 cycles followed by surgery."
113512|NCT01527487|P1|Participant Flow|Eribulin+Cyclophosphamide: ErC|"Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)~Administered every 21 days for 6 cycles followed by surgery."
113513|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
113514|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion."
113515|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
113516|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion."
113517|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
113518|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
113519|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)"
113520|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion"
113521|NCT01527487|E2|Reported Event|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
113522|NCT01527487|E1|Reported Event|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard."
113523|NCT01527370|B1|Baseline|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113606|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113525|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113526|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113527|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113528|NCT01527370|E1|Reported Event|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
113529|NCT01527162|B1|Baseline|All Participants|We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
113530|NCT01527162|P2|Participant Flow|SAFO NOT Worn First, Then Worn|Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
113531|NCT01527162|P1|Participant Flow|SAFO Worn First, Then Not Worn|Child wears their prescribed SAFO for 14 days by random assignment and then not worn
113532|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wears their prescribed SAFO for 14 days
113533|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
113534|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
113535|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
113536|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
113537|NCT01527162|O1|Outcome|SAFO Worn|"Child wears their prescribed SAFO for 14 days~SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment~SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment"
113538|NCT01527162|E2|Reported Event|SAFO Not Worn|SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
113539|NCT01527162|E1|Reported Event|SAFO Worn|SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment
113540|NCT01527006|B3|Baseline|Total|Total of all reporting groups
113541|NCT01527006|B2|Baseline|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113542|NCT01527006|B1|Baseline|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113543|NCT01527006|P2|Participant Flow|Cohort ( ≥ 7 to < 12 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113544|NCT01527006|P1|Participant Flow|Cohort ( ≥ 2 to < 7 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113545|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113546|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113547|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113562|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113607|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113548|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113549|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113550|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113551|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113552|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113553|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113554|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113555|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113556|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113557|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113558|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113559|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113560|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113561|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113563|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113564|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113565|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113566|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113567|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113568|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113569|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113570|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113571|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113572|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113573|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113574|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113575|NCT01527006|O4|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113576|NCT01527006|O3|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113577|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113578|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113579|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113600|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113601|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113580|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113581|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113582|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113583|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113584|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113585|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113586|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113587|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113588|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113589|NCT01527006|E4|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113590|NCT01527006|E3|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
113591|NCT01527006|E2|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113592|NCT01527006|E1|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
113593|NCT01526902|B1|Baseline|Overall Study Population|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
113594|NCT01526902|P2|Participant Flow|Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
113595|NCT01526902|P1|Participant Flow|Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
113596|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113597|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113598|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
113599|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
113608|NCT01526902|E2|Reported Event|Lotrafilcon B / Air Optix MF (CONTROL)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
113609|NCT01526902|E1|Reported Event|Omafilcon A / PC1DMF L2A (TEST)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
113610|NCT01526785|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113611|NCT01526785|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
113612|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113613|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113614|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113615|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113616|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113617|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113618|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
113619|NCT01526785|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
113620|NCT01526733|B1|Baseline|All Enrolled Participants|All participants enrolled in the study.
113621|NCT01526733|P2|Participant Flow|Insulin-sham, Then Insulin-rHuPH20|"In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Phase I and Phase II were separated by a washout period of 5 to 21 days."
113622|NCT01526733|P1|Participant Flow|Insulin-rHuPH20, Then Insulin-sham|"In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Phase I and II were separated by a washout period of 5 to 21 days."
113623|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113624|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113625|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113626|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113627|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113628|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113629|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113699|NCT01525745|B1|Baseline|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113700|NCT01525745|P2|Participant Flow|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
113630|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113631|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113632|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113633|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113634|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113635|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113636|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113637|NCT01526733|E2|Reported Event|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
113638|NCT01526733|E1|Reported Event|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
113639|NCT01526551|B1|Baseline|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
113640|NCT01526551|P1|Participant Flow|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
113641|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
113642|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
113643|NCT01526551|E1|Reported Event|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
113644|NCT01526538|B3|Baseline|Total|Total of all reporting groups
113645|NCT01526538|B2|Baseline|Sugar Pill|"Inactive placebo~sugar pill: placebo"
113646|NCT01526538|B1|Baseline|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
113647|NCT01526538|P2|Participant Flow|Sugar Pill|"Inactive placebo~sugar pill: placebo"
113648|NCT01526538|P1|Participant Flow|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
113649|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
113650|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
113651|NCT01526538|O2|Outcome|Control|Placebo (sugar pill)
113652|NCT01526538|O1|Outcome|D-cycloserine|Study medication under investigation
113653|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
113654|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
113655|NCT01526538|E2|Reported Event|Sugar Pill|"Inactive placebo~sugar pill: placebo"
113656|NCT01526538|E1|Reported Event|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
113657|NCT01526213|B7|Baseline|Total|Total of all reporting groups
113701|NCT01525745|P1|Participant Flow|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
113702|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113658|NCT01526213|B6|Baseline|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113659|NCT01526213|B5|Baseline|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113660|NCT01526213|B4|Baseline|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113661|NCT01526213|B3|Baseline|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113662|NCT01526213|B2|Baseline|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113663|NCT01526213|B1|Baseline|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113664|NCT01526213|P6|Participant Flow|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113665|NCT01526213|P5|Participant Flow|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113666|NCT01526213|P4|Participant Flow|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113667|NCT01526213|P3|Participant Flow|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113668|NCT01526213|P2|Participant Flow|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113669|NCT01526213|P1|Participant Flow|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
113670|NCT01526213|O3|Outcome|Furanocoumarin-free Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
113671|NCT01526213|O2|Outcome|Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
113672|NCT01526213|O1|Outcome|Water|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
113673|NCT01526213|E6|Reported Event|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113703|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113674|NCT01526213|E5|Reported Event|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113675|NCT01526213|E4|Reported Event|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113676|NCT01526213|E3|Reported Event|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113677|NCT01526213|E2|Reported Event|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113678|NCT01526213|E1|Reported Event|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
113679|NCT01526148|B3|Baseline|Total|Total of all reporting groups
113680|NCT01526148|B2|Baseline|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
113681|NCT01526148|B1|Baseline|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
113682|NCT01526148|P2|Participant Flow|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
113683|NCT01526148|P1|Participant Flow|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
113684|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
113685|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
113686|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
113687|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
113688|NCT01526148|E2|Reported Event|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
113689|NCT01526148|E1|Reported Event|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
113690|NCT01525927|B3|Baseline|Total|Total of all reporting groups
113691|NCT01525927|B2|Baseline|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
113692|NCT01525927|B1|Baseline|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders."
113693|NCT01525927|P1|Participant Flow|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
113694|NCT01525927|O1|Outcome|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
113695|NCT01525927|E2|Reported Event|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.~Zero (0) participants analyzed"
113696|NCT01525927|E1|Reported Event|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.~Zero (0) participants analyzed"
113697|NCT01525745|B3|Baseline|Total|Total of all reporting groups
113698|NCT01525745|B2|Baseline|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113704|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113705|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113706|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113707|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113708|NCT01525745|O2|Outcome|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
113709|NCT01525745|O1|Outcome|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
113710|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113711|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113712|NCT01525745|E2|Reported Event|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
113713|NCT01525745|E1|Reported Event|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
113714|NCT01525667|B4|Baseline|Total|Total of all reporting groups
113715|NCT01525667|B3|Baseline|Placebo|Placebo: Single treatment, multiple injections
113716|NCT01525667|B2|Baseline|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
113717|NCT01525667|B1|Baseline|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
113718|NCT01525667|P3|Participant Flow|Placebo|Placebo: Single treatment, multiple injections
113719|NCT01525667|P2|Participant Flow|PLX-PAD High Dose|300M PLX-PAD : Single treatment, multiple injections
113720|NCT01525667|P1|Participant Flow|PLX-PAD Low Dose|150M PLX-PAD : Single treatment, multiple injections
113721|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
113722|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
113723|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
113724|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
113725|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
113726|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
113727|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
113728|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
113729|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
113730|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
113731|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
113732|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
113733|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
113734|NCT01525667|O2|Outcome|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
113735|NCT01525667|O1|Outcome|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
113736|NCT01525667|E3|Reported Event|Placebo|Placebo: Single treatment, multiple injections
113737|NCT01525667|E2|Reported Event|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
113738|NCT01525667|E1|Reported Event|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
113739|NCT01525641|B1|Baseline|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113740|NCT01525641|P1|Participant Flow|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113741|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113742|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113743|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113879|NCT01525563|E1|Reported Event|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
113744|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113745|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113746|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113747|NCT01525641|E1|Reported Event|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
113748|NCT01525628|B6|Baseline|Total|Total of all reporting groups
113749|NCT01525628|B5|Baseline|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113750|NCT01525628|B4|Baseline|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
113751|NCT01525628|B3|Baseline|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113752|NCT01525628|B2|Baseline|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113753|NCT01525628|B1|Baseline|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113754|NCT01525628|P5|Participant Flow|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113755|NCT01525628|P4|Participant Flow|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
113756|NCT01525628|P3|Participant Flow|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113757|NCT01525628|P2|Participant Flow|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113758|NCT01525628|P1|Participant Flow|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113759|NCT01525628|O5|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113760|NCT01525628|O4|Outcome|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
113761|NCT01525628|O3|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113762|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113763|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113764|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113765|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113766|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113767|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113768|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113769|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113770|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113771|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113772|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113773|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113774|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113775|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113776|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113777|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113880|NCT01525420|B3|Baseline|Total|Total of all reporting groups
113778|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113779|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113780|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113781|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113782|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113783|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113784|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113785|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113786|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113787|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113788|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113789|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113790|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113791|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113792|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113793|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113794|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113795|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113796|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113797|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113798|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113799|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113800|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113801|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113802|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113803|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113804|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113805|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113806|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113807|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113808|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113809|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113810|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113811|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113812|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113813|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113814|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113815|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113816|NCT01525628|E5|Reported Event|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
113817|NCT01525628|E4|Reported Event|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
113818|NCT01525628|E3|Reported Event|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
113819|NCT01525628|E2|Reported Event|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113820|NCT01525628|E1|Reported Event|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
113821|NCT01525615|B4|Baseline|Total|Total of all reporting groups
113822|NCT01525615|B3|Baseline|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113823|NCT01525615|B2|Baseline|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113824|NCT01525615|B1|Baseline|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113825|NCT01525615|P3|Participant Flow|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113826|NCT01525615|P2|Participant Flow|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113827|NCT01525615|P1|Participant Flow|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113828|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113829|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113830|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113831|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113832|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113833|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113834|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113835|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113836|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113837|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113838|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113839|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113840|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113841|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113842|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113843|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113844|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113845|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113846|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113941|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113847|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113848|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113849|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113850|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113851|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113852|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113853|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113854|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113855|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113856|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113857|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113858|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113859|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113860|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113861|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113862|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113863|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113864|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113865|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113866|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
113867|NCT01525615|E3|Reported Event|Tio+Olo 5.0 / 5.0 μg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113868|NCT01525615|E2|Reported Event|Tio+Olo 2.5 / 5.0 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
113869|NCT01525615|E1|Reported Event|Placebo|once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
113870|NCT01525563|B1|Baseline|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
113871|NCT01525563|P1|Participant Flow|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
113872|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113873|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113874|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113875|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113876|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113877|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113878|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
113881|NCT01525420|B2|Baseline|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
113882|NCT01525420|B1|Baseline|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
113883|NCT01525420|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT~This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
113884|NCT01525420|P1|Participant Flow|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT~This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
113885|NCT01525420|O2|Outcome|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
113886|NCT01525420|O1|Outcome|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
113887|NCT01525420|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
113888|NCT01525420|E1|Reported Event|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
113889|NCT01525238|B4|Baseline|Total|Total of all reporting groups
113890|NCT01525238|B3|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113891|NCT01525238|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113892|NCT01525238|B1|Baseline|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113893|NCT01525238|P3|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113894|NCT01525238|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113895|NCT01525238|P1|Participant Flow|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113896|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113897|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113898|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113899|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113900|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113901|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113902|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113903|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113904|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113905|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113906|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113907|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113908|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113909|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113910|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113911|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113912|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113913|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113914|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113915|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113916|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113917|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113918|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113919|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113920|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113921|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113922|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113923|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113924|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113925|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113926|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113927|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113928|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113929|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113930|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113931|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113932|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113933|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113934|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113935|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113936|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113937|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113938|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113939|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113940|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113942|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113943|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113944|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113945|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113946|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113947|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113948|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113949|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113950|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113951|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113952|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113953|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113954|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113955|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113956|NCT01525238|E3|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
113957|NCT01525238|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
113958|NCT01525238|E1|Reported Event|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
113959|NCT01525225|B1|Baseline|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
113960|NCT01525225|P1|Participant Flow|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
113961|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
113962|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
113963|NCT01525225|E1|Reported Event|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
113964|NCT01525173|B3|Baseline|Total|Total of all reporting groups
113965|NCT01525173|B2|Baseline|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113966|NCT01525173|B1|Baseline|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113967|NCT01525173|P2|Participant Flow|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113968|NCT01525173|P1|Participant Flow|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113969|NCT01525173|O2|Outcome|LUMIGAN® Alone|1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113970|NCT01525173|O1|Outcome|ALPHAGAN® P and LUMIGAN®|1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113971|NCT01525173|E2|Reported Event|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113972|NCT01525173|E1|Reported Event|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
113973|NCT01524900|B6|Baseline|Total|Total of all reporting groups
113974|NCT01524900|B5|Baseline|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
113975|NCT01524900|B4|Baseline|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
113976|NCT01524900|B3|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
113977|NCT01524900|B2|Baseline|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
113978|NCT01524900|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
113979|NCT01524900|P5|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
113980|NCT01524900|P4|Participant Flow|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
113981|NCT01524900|P3|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
113982|NCT01524900|P2|Participant Flow|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
113983|NCT01524900|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
113984|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
113985|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
113986|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
113987|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
113988|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
113989|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
113990|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
113991|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
113992|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
113993|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
113994|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
113995|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
113996|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
113997|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
113998|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
113999|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
114000|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
114001|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
114002|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
114003|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
114004|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
114005|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
114006|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
114007|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
114008|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
114009|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
114010|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
114011|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
114012|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
114013|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
114014|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
114015|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
114016|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
114017|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
114018|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
114019|NCT01524900|E5|Reported Event|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
114020|NCT01524900|E4|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/ML|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
114021|NCT01524900|E3|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
114022|NCT01524900|E2|Reported Event|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
114023|NCT01524900|E1|Reported Event|Treatment-naïve Patients|Patients who were not pretreated with HIV therapy
114024|NCT01524887|B4|Baseline|Total|Total of all reporting groups
114025|NCT01524887|B3|Baseline|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114026|NCT01524887|B2|Baseline|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114027|NCT01524887|B1|Baseline|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114028|NCT01524887|P3|Participant Flow|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114029|NCT01524887|P2|Participant Flow|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114030|NCT01524887|P1|Participant Flow|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114031|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114032|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114033|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114034|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114035|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114036|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114037|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114038|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114039|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114040|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114041|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114042|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114043|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114044|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114045|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114046|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114047|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114048|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114049|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114050|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114051|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114052|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114053|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114054|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114055|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114056|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114057|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114058|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114059|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114060|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114061|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114062|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114063|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114064|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114065|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114066|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114067|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114068|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114069|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114070|NCT01524887|E3|Reported Event|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
114071|NCT01524887|E2|Reported Event|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114072|NCT01524887|E1|Reported Event|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
114073|NCT01524796|B1|Baseline|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114074|NCT01524796|P1|Participant Flow|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114075|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114076|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114077|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114078|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114079|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114080|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114081|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114082|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114083|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114084|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114085|NCT01524796|E1|Reported Event|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
114086|NCT01524783|B3|Baseline|Total|Total of all reporting groups
114087|NCT01524783|B2|Baseline|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
114088|NCT01524783|B1|Baseline|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
114089|NCT01524783|P2|Participant Flow|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
114090|NCT01524783|P1|Participant Flow|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
114091|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
114092|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
114093|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
114094|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
114095|NCT01524783|E2|Reported Event|Placebo + BSC|Placebo + BSC
114096|NCT01524783|E1|Reported Event|Everolimus + BSC|Everolimus + BSC
114097|NCT01524770|B1|Baseline|Entire Study Population|All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
114098|NCT01524770|P2|Participant Flow|Auto-injector First, Then Manual Syringe|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe."
114099|NCT01524770|P1|Participant Flow|Manual Syringe First, Then Auto-injector|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector."
114100|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
114101|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
114102|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
114103|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
114104|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
114105|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
114106|NCT01524770|E2|Reported Event|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
114107|NCT01524770|E1|Reported Event|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
114108|NCT01524302|B3|Baseline|Total|Total of all reporting groups
114109|NCT01524302|B2|Baseline|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114110|NCT01524302|B1|Baseline|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114111|NCT01524302|P2|Participant Flow|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114112|NCT01524302|P1|Participant Flow|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114113|NCT01524302|O4|Outcome|Log Inhibition of 4.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
114114|NCT01524302|O3|Outcome|Log Inhibition of 2.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
114115|NCT01524302|O2|Outcome|Log Inhibition of 1.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
114116|NCT01524302|O1|Outcome|Log Inhibition of 0.5mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
114117|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114118|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114119|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114120|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114121|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114122|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114123|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114124|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114125|NCT01524302|E2|Reported Event|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
114126|NCT01524302|E1|Reported Event|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
114127|NCT01524198|B3|Baseline|Total|Total of all reporting groups
114128|NCT01524198|B2|Baseline|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
114129|NCT01524198|B1|Baseline|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
114130|NCT01524198|P2|Participant Flow|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
114131|NCT01524198|P1|Participant Flow|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
114177|NCT01523756|E3|Reported Event|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
114132|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
114133|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
114134|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
114135|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
114136|NCT01524198|E2|Reported Event|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
114137|NCT01524198|E1|Reported Event|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
114138|NCT01523964|B5|Baseline|Total|Total of all reporting groups
114139|NCT01523964|B4|Baseline|Healthy Control Ages 8-12 Inclusive|
114140|NCT01523964|B3|Baseline|Healthy Control Ages 3-7 Inclusive|
114141|NCT01523964|B2|Baseline|DMD Subject Ages 8-12 Inclusive|
114142|NCT01523964|B1|Baseline|DMD Subject Ages 3-7 Inclusive|
114143|NCT01523964|P4|Participant Flow|Healthy Control Ages 8-12 Inclusive|
114144|NCT01523964|P3|Participant Flow|Healthy Control Ages 3-7 Inclusive|
114145|NCT01523964|P2|Participant Flow|DMD Subject Ages 8-12 Inclusive|
114146|NCT01523964|P1|Participant Flow|DMD Subject Ages 3-7 Inclusive|
114147|NCT01523964|O4|Outcome|Healthy Control Ages 8-12 Inclusive|
114148|NCT01523964|O3|Outcome|Healthy Control Ages 3-7 Inclusive|
114149|NCT01523964|O2|Outcome|DMD Subject Ages 8-12 Inclusive|
114150|NCT01523964|O1|Outcome|DMD Subject Ages 3-7 Inclusive|
114151|NCT01523964|E4|Reported Event|Healthy Control Ages 8-12 Inclusive|
114152|NCT01523964|E3|Reported Event|Healthy Control Ages 3-7 Inclusive|
114153|NCT01523964|E2|Reported Event|DMD Subject Ages 8-12 Inclusive|
114154|NCT01523964|E1|Reported Event|DMD Subject Ages 3-7 Inclusive|
114155|NCT01523886|B3|Baseline|Total|Total of all reporting groups
114156|NCT01523886|B2|Baseline|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
114157|NCT01523886|B1|Baseline|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
114158|NCT01523886|P2|Participant Flow|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
114159|NCT01523886|P1|Participant Flow|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
114160|NCT01523886|O2|Outcome|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
114161|NCT01523886|O1|Outcome|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
114162|NCT01523886|E2|Reported Event|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
114163|NCT01523886|E1|Reported Event|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
114164|NCT01523873|B1|Baseline|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
114165|NCT01523873|P1|Participant Flow|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
114166|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
114167|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
114168|NCT01523873|O1|Outcome|Patients With Moderate to Severe Impaired Renal Function|Patients identified with moderate to severe impaired renal function at the time of inclusion (i.e. estimated Glomerular Filtration Rate (eGFR) or estimated creatinine clearance (eCrCl) <60 ml/min (1.73 m2))
114169|NCT01523873|O1|Outcome|Safety Population|Safety Population included All Included Patients administered with Dotarem.
114170|NCT01523873|E1|Reported Event|Safety Population|Safety Population included All Included Patients administered with Dotarem.
114171|NCT01523756|B1|Baseline|Overall Study|
114172|NCT01523756|P2|Participant Flow|Own Product (Baseline) - Test Product 2 - Test Product 1|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
114173|NCT01523756|P1|Participant Flow|Own Product (Baseline) - Test Product 1 - Test Product 2|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
114174|NCT01523756|O3|Outcome|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
114175|NCT01523756|O2|Outcome|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
114176|NCT01523756|O1|Outcome|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
114178|NCT01523756|E2|Reported Event|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
114179|NCT01523756|E1|Reported Event|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
114180|NCT01523743|B1|Baseline|All Study Participants|"125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.~The baseline and analysis data are based on the ITT population."
114181|NCT01523743|P2|Participant Flow|First Standard Care; Then Compact Catheter|First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
114182|NCT01523743|P1|Participant Flow|First Compact Catheter, Then Standard Care|First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
114183|NCT01523743|O2|Outcome|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
114184|NCT01523743|O1|Outcome|Compact Catheter|Compact intermittent catheter
114185|NCT01523743|E2|Reported Event|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
114186|NCT01523743|E1|Reported Event|Compact Catheter|Compact intermittent catheter
114187|NCT01523587|B3|Baseline|Total|Total of all reporting groups
114188|NCT01523587|B2|Baseline|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114189|NCT01523587|B1|Baseline|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114190|NCT01523587|P2|Participant Flow|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114191|NCT01523587|P1|Participant Flow|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114192|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114193|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114194|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114195|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114196|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114197|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114198|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114199|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114200|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114201|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114202|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114203|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114204|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114205|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114206|NCT01523587|E2|Reported Event|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
114319|NCT01522456|P1|Participant Flow|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
114207|NCT01523587|E1|Reported Event|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
114208|NCT01523392|B3|Baseline|Total|Total of all reporting groups
114209|NCT01523392|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
114210|NCT01523392|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)
114211|NCT01523392|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
114212|NCT01523392|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)
114213|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114214|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114215|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114216|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114217|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
114218|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114219|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
114220|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114221|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
114222|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114223|NCT01523392|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
114224|NCT01523392|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114225|NCT01523366|B3|Baseline|Total|Total of all reporting groups
114226|NCT01523366|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
114227|NCT01523366|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
114228|NCT01523366|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
114229|NCT01523366|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
114230|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114231|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114232|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114233|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
114234|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
114235|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
114236|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
114237|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
114238|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
114239|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
114240|NCT01523366|E2|Reported Event|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
114241|NCT01523366|E1|Reported Event|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
114242|NCT01523301|B3|Baseline|Total Title|
114243|NCT01523301|B2|Baseline|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114320|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114244|NCT01523301|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114245|NCT01523301|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114246|NCT01523301|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114247|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114248|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114249|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114250|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114251|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114252|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114253|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114254|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114255|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114256|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114257|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114258|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114259|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114321|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114260|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
114261|NCT01523301|E2|Reported Event|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114262|NCT01523301|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
114263|NCT01522976|B4|Baseline|Total|Total of all reporting groups
114264|NCT01522976|B3|Baseline|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114265|NCT01522976|B2|Baseline|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114266|NCT01522976|B1|Baseline|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114267|NCT01522976|P3|Participant Flow|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114268|NCT01522976|P2|Participant Flow|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114269|NCT01522976|P1|Participant Flow|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114270|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
114271|NCT01522976|O2|Outcome|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
114272|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
114273|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114274|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114275|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114276|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114277|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114278|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114279|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114280|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114281|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114282|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
114283|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
114284|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
114285|NCT01522976|E3|Reported Event|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
114286|NCT01522976|E2|Reported Event|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
114287|NCT01522976|E1|Reported Event|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
114288|NCT01522924|B3|Baseline|Total|Total of all reporting groups
114289|NCT01522924|B2|Baseline|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114290|NCT01522924|B1|Baseline|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114291|NCT01522924|P2|Participant Flow|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114292|NCT01522924|P1|Participant Flow|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114293|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114294|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114295|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114296|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114297|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114298|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114299|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114300|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114301|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114302|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114303|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114304|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114305|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
114306|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
114307|NCT01522924|E2|Reported Event|Counseling/Debriefing|participated in counseling and debriefing sessions
114308|NCT01522924|E1|Reported Event|Lecture Only|participated in lecture only
114309|NCT01522703|B3|Baseline|Total|Total of all reporting groups
114310|NCT01522703|B2|Baseline|Alfalfa Sprouts (Placebo Control)|
114311|NCT01522703|B1|Baseline|Broccoli Sprouts|
114312|NCT01522703|P2|Participant Flow|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts 3 consecutive days
114313|NCT01522703|P1|Participant Flow|Broccoli Sprouts|ingestion of broccoli sprouts 3 consecutive days
114314|NCT01522703|O2|Outcome|Broccoli Sprouts|ingestion of broccoli sprouts for 3 consecutive days
114315|NCT01522703|O1|Outcome|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts for 3 consecutive days
114316|NCT01522703|E2|Reported Event|Alfalfa Sprouts (Placebo Control)|
114317|NCT01522703|E1|Reported Event|Broccoli Sprouts|
114318|NCT01522456|B1|Baseline|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
114322|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114323|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114324|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114325|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114326|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114327|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114328|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114329|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114330|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114331|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114332|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114333|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114334|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114335|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114336|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114337|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114338|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114339|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114340|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114341|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114342|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114343|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114344|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114345|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114346|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114347|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114348|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114349|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114350|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114351|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114352|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114353|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114354|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114355|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114356|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114357|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114358|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114359|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114360|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114361|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114362|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114363|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114364|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114365|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114366|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114367|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114368|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114369|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114370|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114371|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114372|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114373|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114374|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114375|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114376|NCT01522456|E3|Reported Event|Non-application Site|Adverse events occurring on non-application sites
114377|NCT01522456|E2|Reported Event|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
114378|NCT01522456|E1|Reported Event|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
114379|NCT01522339|B1|Baseline|Pilot Group|Patients who had an MRI in the NICU scanner.
114380|NCT01522339|P1|Participant Flow|Pilot Group|Patients who received an MRI.
114381|NCT01522339|O1|Outcome|Pilot Group|Patients who had an MRI on the NICU scanner.
114382|NCT01522339|O1|Outcome|Pilot Group|Patients who received an MRI on the NICU scanner.
114383|NCT01522339|E1|Reported Event|Pilot Group|Patients who had an MRI in the NICU scanner.
114384|NCT01522131|B3|Baseline|Total|Total of all reporting groups
114385|NCT01522131|B2|Baseline|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
114386|NCT01522131|B1|Baseline|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
114387|NCT01522131|P2|Participant Flow|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
114388|NCT01522131|P1|Participant Flow|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
114389|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
114390|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
114391|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
114392|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
114393|NCT01522131|E2|Reported Event|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
114394|NCT01522131|E1|Reported Event|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
114395|NCT01521923|B5|Baseline|Total Title|
114396|NCT01521923|B4|Baseline|CZP+MTX / CZP Q2W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2
114397|NCT01521923|B3|Baseline|CZP+MTX / CZP Q4W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2
114398|NCT01521923|B2|Baseline|CZP+MTX / PBO+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
114399|NCT01521923|B1|Baseline|PBO+MTX / PBO+MTX|Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
114400|NCT01521923|P4|Participant Flow|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114401|NCT01521923|P3|Participant Flow|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114402|NCT01521923|P2|Participant Flow|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114403|NCT01521923|P1|Participant Flow|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114404|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114405|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114406|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114407|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114408|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114409|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114410|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114411|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114412|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114413|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114414|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114415|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114416|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114417|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114418|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114419|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114478|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114420|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114421|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114422|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114423|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114424|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114425|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114426|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114427|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114428|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114429|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114430|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114431|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114432|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114433|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114434|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114435|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114436|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114437|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114438|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114439|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114440|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114441|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114442|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114443|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114444|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114445|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114446|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114447|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114448|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
116281|NCT01515540|P2|Participant Flow|Control|placebo patch
114449|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114450|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114451|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114452|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114453|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114454|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114455|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114456|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114457|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114458|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114459|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114460|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114461|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114462|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114463|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114464|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114465|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114466|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114467|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114468|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114469|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114470|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114471|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114472|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114473|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114474|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114475|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114476|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114477|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
116282|NCT01515540|P1|Participant Flow|Lidocaine|5% lidoderm patch
114479|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114480|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114481|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114482|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114483|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114484|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114485|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114486|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114487|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114488|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114489|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114490|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114491|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114492|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114493|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114494|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114495|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114496|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114497|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114498|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114499|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114500|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114501|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114502|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114503|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114504|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114505|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114506|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114507|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
116283|NCT01515540|O2|Outcome|Control|placebo patch
174948|NCT01272583|O1|Outcome|Baseline|
114508|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114509|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114510|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114511|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114512|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114513|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114514|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114515|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114516|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114517|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set [FAS])|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114518|NCT01521923|E4|Reported Event|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
114519|NCT01521923|E3|Reported Event|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
114520|NCT01521923|E2|Reported Event|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114521|NCT01521923|E1|Reported Event|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
114522|NCT01521897|B1|Baseline|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114523|NCT01521897|P1|Participant Flow|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114524|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114525|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114526|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114527|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114528|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114529|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114530|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114531|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114532|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114533|NCT01521897|E1|Reported Event|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
114534|NCT01521884|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114535|NCT01521884|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114536|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114537|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114538|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114539|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114540|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114541|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114542|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114543|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114544|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114545|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114546|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114547|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114548|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114549|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114550|NCT01521884|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
114551|NCT01521871|B3|Baseline|Total|Total of all reporting groups
114552|NCT01521871|B2|Baseline|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
114553|NCT01521871|B1|Baseline|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114554|NCT01521871|P2|Participant Flow|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
114555|NCT01521871|P1|Participant Flow|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
116284|NCT01515540|O1|Outcome|Lidocaine|5% lidoderm patch
114556|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114557|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114558|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114559|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114560|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114561|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114562|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114563|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114564|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114565|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114566|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114567|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114568|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114569|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114570|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114571|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114572|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114573|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114574|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114575|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114576|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114577|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114578|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114579|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114580|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114581|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114582|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114583|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114584|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
116285|NCT01515540|E2|Reported Event|Control|placebo patch
114585|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114586|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114587|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114588|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114589|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
114590|NCT01521871|E2|Reported Event|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
114591|NCT01521871|E1|Reported Event|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
114592|NCT01521845|B3|Baseline|Total|Total of all reporting groups
114593|NCT01521845|B2|Baseline|Control|This group is without omega 3 : just receives standard treatment
114594|NCT01521845|B1|Baseline|Omega 3|receive omega 3 in addition to standard treatment
114595|NCT01521845|P2|Participant Flow|Control|This group is without omega 3 : just receives standard treatment
114596|NCT01521845|P1|Participant Flow|Omega 3|receive omega 3 in addition to standard treatment
114597|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
114598|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
114599|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
114600|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
114601|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
114602|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
114603|NCT01521845|E2|Reported Event|Control|This group is without omega 3 : just receives standard treatment
114604|NCT01521845|E1|Reported Event|Omega 3|receive omega 3 in addition to standard treatment
114605|NCT01521780|B1|Baseline|All Participants|Participants who enrolled in the study
114606|NCT01521780|P3|Participant Flow|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114607|NCT01521780|P2|Participant Flow|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114608|NCT01521780|P1|Participant Flow|Imaging|Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
114609|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114610|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114611|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114612|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114613|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114614|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114615|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114616|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114617|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114618|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
114619|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
114620|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114621|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114622|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114623|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114624|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114625|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114626|NCT01521780|E3|Reported Event|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
114627|NCT01521780|E2|Reported Event|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
114628|NCT01521780|E1|Reported Event|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
114629|NCT01521559|B3|Baseline|Total|Total of all reporting groups
114630|NCT01521559|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
114631|NCT01521559|B1|Baseline|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
114783|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
174949|NCT01272583|O3|Outcome|Placebo|
114632|NCT01521559|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
114633|NCT01521559|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
114634|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
114635|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
114636|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24
114637|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
114638|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
114639|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
114640|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
114641|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
114642|NCT01521559|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
114643|NCT01521559|E1|Reported Event|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
114644|NCT01521546|B3|Baseline|Total|Total of all reporting groups
114645|NCT01521546|B2|Baseline|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
114646|NCT01521546|B1|Baseline|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
114647|NCT01521546|P2|Participant Flow|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
114648|NCT01521546|P1|Participant Flow|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
114649|NCT01521546|O2|Outcome|Eplerenone|eplerenone one tablet by mouth daily for 12 months
114650|NCT01521546|O1|Outcome|Placebo|placebo: one tablet by mouth daily for 12 months
114651|NCT01521546|E2|Reported Event|Eplerenone|eplerenone one tablet daily for 12 months
114652|NCT01521546|E1|Reported Event|Placebo|placebo one tablet daily for 12 months
114653|NCT01521507|B3|Baseline|Total|Total of all reporting groups
114654|NCT01521507|B2|Baseline|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
114655|NCT01521507|B1|Baseline|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
114656|NCT01521507|P2|Participant Flow|Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment|"Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
114657|NCT01521507|P1|Participant Flow|LipiFlow Treatment|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
114658|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
114659|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
116286|NCT01515540|E1|Reported Event|Lidocaine|5% lidoderm patch
114660|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
114661|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
114662|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
114663|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
114664|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
114665|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
114666|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
114667|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
114668|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
114669|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
114670|NCT01521507|E3|Reported Event|Crossover LipiFlow Treatment|After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
114671|NCT01521507|E2|Reported Event|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
114672|NCT01521507|E1|Reported Event|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
114673|NCT01521364|B1|Baseline|Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114674|NCT01521364|P1|Participant Flow|0mg, 250mg and 500mg Claritromycin|Patients receive 300mg linezolid twice a day during entire study.
114675|NCT01521364|O3|Outcome|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114676|NCT01521364|O2|Outcome|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114677|NCT01521364|O1|Outcome|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114678|NCT01521364|O3|Outcome|500mg Clarithromycin|
114679|NCT01521364|O2|Outcome|250mg Clarithromycin|
114784|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114785|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114680|NCT01521364|O1|Outcome|0mg Claritrhomycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114681|NCT01521364|E3|Reported Event|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114682|NCT01521364|E2|Reported Event|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114683|NCT01521364|E1|Reported Event|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
114684|NCT01521260|B3|Baseline|Total|Total of all reporting groups
114685|NCT01521260|B2|Baseline|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
114686|NCT01521260|B1|Baseline|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
114687|NCT01521260|P2|Participant Flow|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
114688|NCT01521260|P1|Participant Flow|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
114689|NCT01521260|O2|Outcome|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
114690|NCT01521260|O1|Outcome|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
114691|NCT01521260|E2|Reported Event|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
114692|NCT01521260|E1|Reported Event|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
114693|NCT01521143|B5|Baseline|Total|Total of all reporting groups
114694|NCT01521143|B4|Baseline|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114695|NCT01521143|B3|Baseline|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114696|NCT01521143|B2|Baseline|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114697|NCT01521143|B1|Baseline|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114698|NCT01521143|P4|Participant Flow|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114699|NCT01521143|P3|Participant Flow|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114700|NCT01521143|P2|Participant Flow|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
115572|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
114701|NCT01521143|P1|Participant Flow|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114702|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114703|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114704|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114705|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114706|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114707|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114708|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114709|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114710|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114711|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114712|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114713|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114714|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114715|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114716|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114717|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114718|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114719|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114720|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114721|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114722|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114723|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114724|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114725|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114726|NCT01521143|E4|Reported Event|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
114727|NCT01521143|E3|Reported Event|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114728|NCT01521143|E2|Reported Event|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
114729|NCT01521143|E1|Reported Event|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
114730|NCT01521026|B3|Baseline|Total|Total of all reporting groups
114731|NCT01521026|B2|Baseline|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
114732|NCT01521026|B1|Baseline|Cognitive Training|Cognitive training group
114733|NCT01521026|P2|Participant Flow|Standard Pharmacotherapy|Standard pharmacotherapy with regular clinician
114734|NCT01521026|P1|Participant Flow|Cognitive Training|Cognitive training group
114735|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
114736|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
114737|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
114738|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
114739|NCT01521026|E2|Reported Event|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
114740|NCT01521026|E1|Reported Event|Cognitive Training|Cognitive training group
114741|NCT01520987|B9|Baseline|Total|Total of all reporting groups
114742|NCT01520987|B8|Baseline|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
114743|NCT01520987|B7|Baseline|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114744|NCT01520987|B6|Baseline|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114745|NCT01520987|B5|Baseline|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114746|NCT01520987|B4|Baseline|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
114747|NCT01520987|B3|Baseline|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114748|NCT01520987|B2|Baseline|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114749|NCT01520987|B1|Baseline|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114750|NCT01520987|P8|Participant Flow|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
114751|NCT01520987|P7|Participant Flow|Japanese 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114752|NCT01520987|P6|Participant Flow|Japanese 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114753|NCT01520987|P5|Participant Flow|Japanese 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114754|NCT01520987|P4|Participant Flow|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
114755|NCT01520987|P3|Participant Flow|Caucasian 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114756|NCT01520987|P2|Participant Flow|Caucasian 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114757|NCT01520987|P1|Participant Flow|Caucasian 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
114758|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114759|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114760|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114761|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114762|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114763|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114764|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114765|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114766|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114767|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114768|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114769|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114770|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114771|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114772|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114773|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114774|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114775|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114776|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114777|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114778|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114779|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114780|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114781|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114782|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114786|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114787|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114788|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114789|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114790|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114791|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114792|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114793|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114794|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114795|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114796|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114797|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114798|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114799|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114800|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114801|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114802|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114803|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114804|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114805|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114806|NCT01520987|E8|Reported Event|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
114807|NCT01520987|E7|Reported Event|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114808|NCT01520987|E6|Reported Event|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114809|NCT01520987|E5|Reported Event|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114810|NCT01520987|E4|Reported Event|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
114811|NCT01520987|E3|Reported Event|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114812|NCT01520987|E2|Reported Event|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114813|NCT01520987|E1|Reported Event|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
114814|NCT01520922|B3|Baseline|Total|Total of all reporting groups
114815|NCT01520922|B2|Baseline|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114816|NCT01520922|B1|Baseline|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114817|NCT01520922|P2|Participant Flow|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114818|NCT01520922|P1|Participant Flow|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114819|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114820|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114821|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114822|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114823|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114824|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114825|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114826|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114827|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114828|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114829|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114830|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114831|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114832|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114833|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114834|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114835|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114836|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114837|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114972|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114838|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114839|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114840|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114841|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114842|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114843|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114844|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114845|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114846|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114847|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114848|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114849|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114850|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114851|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114852|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114853|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114973|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114854|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114855|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114856|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114857|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114858|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114859|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114860|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114861|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114862|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114863|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114864|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114865|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114866|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114867|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114868|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114869|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114974|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114870|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114871|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114872|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114873|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114874|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114875|NCT01520922|E2|Reported Event|Ofatumumab + Bendamustine 90mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114876|NCT01520922|E1|Reported Event|Ofatumumab + Bendamustine 70mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
114877|NCT01520909|B3|Baseline|Total|Total of all reporting groups
114878|NCT01520909|B2|Baseline|Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines.
114879|NCT01520909|B1|Baseline|Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day. In Part 2, participants received eltrombopag. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114880|NCT01520909|P3|Participant Flow|Part 2 (Open-Label Period) Eltrombopag|All participants receiving placebo in Part 1 received eltrombopag in Part 2 following starting dose guidelines for Part 1. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants receiving eltrombopag in Part 1 continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
114881|NCT01520909|P2|Participant Flow|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
114882|NCT01520909|P1|Participant Flow|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day). Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
114883|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
116287|NCT01515488|B3|Baseline|Total|Total of all reporting groups
114884|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114885|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114886|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114887|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114888|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114889|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114890|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114891|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114892|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114893|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114894|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114895|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114896|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114897|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
114898|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
115573|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
114899|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114900|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114901|NCT01520909|O1|Outcome|Part 1 (Randomized Period) - Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114902|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114903|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114904|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114905|NCT01520909|O1|Outcome|EPart 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114906|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114907|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114908|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114909|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114910|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114911|NCT01520909|O1|Outcome|Part 1(Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
115574|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
114912|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114913|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114914|NCT01520909|O1|Outcome|Part 1 (Randmoized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114915|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114916|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114917|NCT01520909|O1|Outcome|Part 1 (Randmoized Period) -Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114918|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114919|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114920|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114921|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114922|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114938|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
115332|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
114923|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114924|NCT01520909|O2|Outcome|Part 1 (Randomized Period) -Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114925|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114926|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114927|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114928|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114929|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114930|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114931|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114932|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114933|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114934|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114935|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114936|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114937|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
119185|NCT01499290|E2|Reported Event|Meropenem|1000 mg: IV treatment
114939|NCT01520909|O1|Outcome|Part 1 (Randomized Period)- Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day).
114940|NCT01520909|E3|Reported Event|Part 2: Eltrombopag|In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
114941|NCT01520909|E2|Reported Event|Part 1: Placebo|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
114942|NCT01520909|E1|Reported Event|Part 1: Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
114943|NCT01520727|B10|Baseline|Total|Total of all reporting groups
114944|NCT01520727|B9|Baseline|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
114945|NCT01520727|B8|Baseline|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114946|NCT01520727|B7|Baseline|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114947|NCT01520727|B6|Baseline|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114948|NCT01520727|B5|Baseline|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114949|NCT01520727|B4|Baseline|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114950|NCT01520727|B3|Baseline|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114951|NCT01520727|B2|Baseline|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114952|NCT01520727|B1|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114953|NCT01520727|P9|Participant Flow|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
114954|NCT01520727|P8|Participant Flow|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114955|NCT01520727|P7|Participant Flow|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114956|NCT01520727|P6|Participant Flow|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114957|NCT01520727|P5|Participant Flow|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114958|NCT01520727|P4|Participant Flow|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114959|NCT01520727|P3|Participant Flow|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114960|NCT01520727|P2|Participant Flow|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114961|NCT01520727|P1|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114962|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114963|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114964|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114965|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114966|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114967|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114968|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114969|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114970|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114971|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
115575|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
114975|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114976|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114977|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114978|NCT01520727|O9|Outcome|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
114979|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114980|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114981|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114982|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114983|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114984|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114985|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114986|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114987|NCT01520727|E9|Reported Event|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
114988|NCT01520727|E8|Reported Event|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114989|NCT01520727|E7|Reported Event|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114990|NCT01520727|E6|Reported Event|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114991|NCT01520727|E5|Reported Event|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114992|NCT01520727|E4|Reported Event|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114993|NCT01520727|E3|Reported Event|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114994|NCT01520727|E2|Reported Event|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114995|NCT01520727|E1|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
114996|NCT01520714|B3|Baseline|Total|Total of all reporting groups
114997|NCT01520714|B2|Baseline|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
114998|NCT01520714|B1|Baseline|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
114999|NCT01520714|P2|Participant Flow|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115000|NCT01520714|P1|Participant Flow|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115001|NCT01520714|O2|Outcome|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115166|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115333|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115002|NCT01520714|O1|Outcome|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115003|NCT01520714|E2|Reported Event|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115004|NCT01520714|E1|Reported Event|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
115005|NCT01520532|B1|Baseline|Ablation|
115006|NCT01520532|P1|Participant Flow|Ablation|Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
115007|NCT01520532|O1|Outcome|Ablation|
115008|NCT01520532|O1|Outcome|Ablation|
115009|NCT01520532|O1|Outcome|Ablation|
115010|NCT01520532|E1|Reported Event|Ablation|
115011|NCT01520506|B1|Baseline|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
115012|NCT01520506|P1|Participant Flow|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
115013|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
115014|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
115015|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
115016|NCT01520506|E1|Reported Event|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
115017|NCT01520402|B1|Baseline|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
115018|NCT01520402|P1|Participant Flow|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
115019|NCT01520402|O1|Outcome|CYP2C9/VKORC1 Genotype Group|Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant).
115020|NCT01520402|O4|Outcome|Demographic Plus CYP2C9 and VKORC1 and CYP4F2|
115021|NCT01520402|O3|Outcome|Demographic Plus CYP2C9 and VKORC1|
115022|NCT01520402|O2|Outcome|Demographic Plus CYP2C9|
115023|NCT01520402|O1|Outcome|Demographic Only|Demographic variables were gender, age, and race.
115024|NCT01520402|O1|Outcome|CYP4F2 (p.V433M; c.1297G>A)|"CYP4F2 G/G was defined as wild-type, CYP4F2 G/A was defined as single-variant, and CYP4F2 A/A was defined as double-variant"
115025|NCT01520402|O2|Outcome|VKORC1 -1639 G>A|"VKORC1 GG was defined as wild-type; VKORC1 G/A was defined as single variant; and VKORC1 A/A was defined as double variant."
115026|NCT01520402|O1|Outcome|CYP2C9|"The wild-type CYP2C9 allele (*1) was assigned in the absence of other detectable variant alleles. Extensive metabolizers (EMs) were defined as *1/*1 wild-type, intermediate metabolizers (IMs) as *1/variant single variant; and poor metabolizers (PMs) as variant/variant double variant."
115334|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115027|NCT01520402|E1|Reported Event|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
115028|NCT01519960|B4|Baseline|Total|Total of all reporting groups
115029|NCT01519960|B3|Baseline|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115030|NCT01519960|B2|Baseline|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115031|NCT01519960|B1|Baseline|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115032|NCT01519960|P3|Participant Flow|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115033|NCT01519960|P2|Participant Flow|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115034|NCT01519960|P1|Participant Flow|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 square meters (m^2), 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg.
115035|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115036|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115037|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115038|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115039|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115051|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115040|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115041|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115042|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115043|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115044|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115045|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115046|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115047|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115048|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115049|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115050|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115167|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115467|NCT01519466|B3|Baseline|Total|Total of all reporting groups
115052|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115053|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115054|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115055|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115056|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115057|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115058|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115059|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115060|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115061|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115062|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115063|NCT01519960|O1|Outcome|All Groups Combined|Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115064|NCT01519960|O3|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115065|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115066|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115067|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115068|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115069|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115070|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115071|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115072|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115073|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115074|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115075|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115076|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115077|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115078|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115079|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115080|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115081|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115082|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115083|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115084|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115085|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115086|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115087|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115088|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115089|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115090|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115102|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115091|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115092|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115093|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115094|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115095|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115096|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115097|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115098|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115099|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115100|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115101|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115103|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115104|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115105|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115106|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115107|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115108|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115109|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115110|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115111|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115112|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115113|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115114|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115115|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115116|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115117|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115118|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115119|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115120|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115121|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115122|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115123|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115124|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115165|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
126344|NCT01469039|B4|Baseline|Total|Total of all reporting groups
115125|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115126|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115127|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115128|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115129|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115130|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115131|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115132|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115133|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
115134|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115135|NCT01519960|E4|Reported Event|Group D: Switch to PEG-IFN Monotherapy|Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.
115576|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115136|NCT01519960|E3|Reported Event|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115137|NCT01519960|E2|Reported Event|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.
115138|NCT01519960|E1|Reported Event|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
115139|NCT01519934|B1|Baseline|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115140|NCT01519934|P1|Participant Flow|Ulthera-treated Subjects|All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
115141|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115142|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115143|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115144|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115145|NCT01519934|E1|Reported Event|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
115146|NCT01519921|B3|Baseline|Total|Total of all reporting groups
115147|NCT01519921|B2|Baseline|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115148|NCT01519921|B1|Baseline|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115149|NCT01519921|P2|Participant Flow|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115150|NCT01519921|P1|Participant Flow|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115151|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115152|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115153|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115154|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115155|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115156|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115157|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115158|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115159|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115160|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115161|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115162|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115163|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
115164|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115168|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115169|NCT01519921|E2|Reported Event|PEG-IFN Alfa-2a (YMDD Mutant)|Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
115170|NCT01519921|E1|Reported Event|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
115171|NCT01519882|B3|Baseline|Total|Total of all reporting groups
115172|NCT01519882|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115173|NCT01519882|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115174|NCT01519882|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115175|NCT01519882|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115176|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115177|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115178|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115179|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115180|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115181|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115182|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115183|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115184|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115185|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115186|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115290|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
129251|NCT01458275|B4|Baseline|Total|Total of all reporting groups
115187|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115188|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115189|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115190|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115191|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115192|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115193|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115194|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115195|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115196|NCT01519882|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
115197|NCT01519882|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
115198|NCT01519791|B3|Baseline|Total Title|
115199|NCT01519791|B2|Baseline|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115200|NCT01519791|B1|Baseline|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115201|NCT01519791|P2|Participant Flow|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115202|NCT01519791|P1|Participant Flow|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115203|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115577|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115204|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115205|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115206|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115207|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115208|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115209|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115210|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115211|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115212|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115213|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115214|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115215|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115216|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115217|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115291|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115666|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115218|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115219|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115220|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115221|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115222|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115223|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115224|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115225|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115226|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115227|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115228|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115229|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115230|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115231|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115292|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
117597|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
115232|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115233|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115234|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115235|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115236|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115237|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115238|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115239|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115240|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115241|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115242|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115243|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115244|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115245|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115293|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
118850|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
115246|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115247|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115248|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115249|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115250|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115251|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115252|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115253|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115254|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115255|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115256|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115257|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115258|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115259|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115294|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
118851|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
115260|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115261|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115262|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115263|NCT01519791|E2|Reported Event|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115264|NCT01519791|E1|Reported Event|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
115265|NCT01519778|B1|Baseline|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
115266|NCT01519778|P1|Participant Flow|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
115267|NCT01519778|O1|Outcome|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
115268|NCT01519778|E1|Reported Event|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
115269|NCT01519765|B3|Baseline|Total|Total of all reporting groups
115270|NCT01519765|B2|Baseline|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115271|NCT01519765|B1|Baseline|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115272|NCT01519765|P2|Participant Flow|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115273|NCT01519765|P1|Participant Flow|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115274|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115275|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115276|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115277|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115278|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115279|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115280|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115281|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115282|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115283|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115284|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115285|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115286|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115287|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115288|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115289|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115295|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115296|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115297|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115298|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115299|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115300|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115301|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115302|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115303|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115304|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115305|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115306|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115307|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
115308|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115309|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115310|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115311|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115312|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115313|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
115314|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115315|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
115316|NCT01519765|E2|Reported Event|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
115317|NCT01519765|E1|Reported Event|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
115318|NCT01519713|B4|Baseline|Total|Total of all reporting groups
115319|NCT01519713|B3|Baseline|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115320|NCT01519713|B2|Baseline|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115321|NCT01519713|B1|Baseline|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115322|NCT01519713|P3|Participant Flow|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115323|NCT01519713|P2|Participant Flow|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115324|NCT01519713|P1|Participant Flow|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115325|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115326|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115327|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115328|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115329|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115330|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115331|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115335|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115336|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115337|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115338|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115339|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115340|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115341|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115342|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115343|NCT01519713|E3|Reported Event|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
115344|NCT01519713|E2|Reported Event|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
115345|NCT01519713|E1|Reported Event|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
115346|NCT01519700|B5|Baseline|Total|Total of all reporting groups
115347|NCT01519700|B4|Baseline|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
115348|NCT01519700|B3|Baseline|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
115349|NCT01519700|B2|Baseline|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
115350|NCT01519700|B1|Baseline|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
115351|NCT01519700|P4|Participant Flow|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
115352|NCT01519700|P3|Participant Flow|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
115353|NCT01519700|P2|Participant Flow|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
115354|NCT01519700|P1|Participant Flow|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
115355|NCT01519700|O5|Outcome|Total|All patients
115356|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
115357|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
115358|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
115359|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
115360|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
115361|NCT01519700|O2|Outcome|EP2006 & Neupogen + Neupogen & EP2006|All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006.
115362|NCT01519700|O1|Outcome|EP2006 + Neupogen|All subjects randomized to receive either EP2006 or Neupogen.
115363|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
115364|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
115365|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
115366|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
115367|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
115368|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
115369|NCT01519700|O5|Outcome|Total|All patients
115370|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
115371|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
115372|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
115373|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
115374|NCT01519700|O5|Outcome|Total|All patients
115375|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
115376|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
115377|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
115378|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
115379|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
115380|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
115381|NCT01519700|E4|Reported Event|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
115382|NCT01519700|E3|Reported Event|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
115383|NCT01519700|E2|Reported Event|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
115384|NCT01519700|E1|Reported Event|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
115385|NCT01519674|B4|Baseline|Total|Total of all reporting groups
115468|NCT01519466|B2|Baseline|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115386|NCT01519674|B3|Baseline|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115387|NCT01519674|B2|Baseline|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115388|NCT01519674|B1|Baseline|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115389|NCT01519674|P3|Participant Flow|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115390|NCT01519674|P2|Participant Flow|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115391|NCT01519674|P1|Participant Flow|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115392|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115393|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115394|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115395|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115396|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115397|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115398|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115399|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115400|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115401|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115402|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115403|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115404|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115405|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115406|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115407|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115408|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115409|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115410|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115411|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115412|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115413|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115414|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115415|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115416|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115417|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115418|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115419|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
129355|NCT01458106|B3|Baseline|Total|Total of all reporting groups
115420|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115421|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115422|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115423|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115424|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115425|NCT01519674|E3|Reported Event|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115426|NCT01519674|E2|Reported Event|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
115427|NCT01519674|E1|Reported Event|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
115428|NCT01519661|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115429|NCT01519661|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115430|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115431|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115432|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115433|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115434|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115435|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
134766|NCT01436006|B1|Baseline|CT Scan|patient with cancer
115436|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
115437|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115438|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115439|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115440|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115441|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115442|NCT01519661|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
115443|NCT01519648|B3|Baseline|Total|Total of all reporting groups
115444|NCT01519648|B2|Baseline|Allo- or Auto- Transplant Recipients|
115445|NCT01519648|B1|Baseline|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
115446|NCT01519648|P2|Participant Flow|Allo- or Auto- Transplant Recipients|
115447|NCT01519648|P1|Participant Flow|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
115448|NCT01519648|O2|Outcome|Allo- or Auto- Transplant Recipients|Allo- or auto- transplant recipients
115449|NCT01519648|O1|Outcome|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
115450|NCT01519648|E2|Reported Event|Allo- or Auto- Transplant Recipients|
115451|NCT01519648|E1|Reported Event|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
115452|NCT01519518|B3|Baseline|Total|Total of all reporting groups
115453|NCT01519518|B2|Baseline|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115454|NCT01519518|B1|Baseline|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115455|NCT01519518|P2|Participant Flow|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115456|NCT01519518|P1|Participant Flow|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115457|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115458|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115459|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115460|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115461|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115462|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115463|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115464|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115465|NCT01519518|E2|Reported Event|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
115466|NCT01519518|E1|Reported Event|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
115469|NCT01519466|B1|Baseline|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115470|NCT01519466|P2|Participant Flow|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115471|NCT01519466|P1|Participant Flow|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115472|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115473|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115474|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115475|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115476|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115477|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115478|NCT01519466|E2|Reported Event|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
115479|NCT01519466|E1|Reported Event|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
115480|NCT01519427|B1|Baseline|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115481|NCT01519427|P1|Participant Flow|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115482|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115483|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115484|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115485|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115486|NCT01519427|E1|Reported Event|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
115487|NCT01519323|B1|Baseline|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115488|NCT01519323|P2|Participant Flow|Vemurafenib Dose Escalation Cohort Level 2|Participants received 960 mg of vemurafenib by mouth BID.
115489|NCT01519323|P1|Participant Flow|Vemurafenib Dose Escalation Cohort Level 1|Participants received 720 milligram (mg) of vemurafenib by mouth twice daily (BID).
115490|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115491|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115492|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115493|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115525|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115526|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
135194|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
115494|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115495|NCT01519323|O2|Outcome|Vemurafenib 960 mg|Participants enrolled in the second cohort received vemurafenib 960 mg by mouth BID.
115496|NCT01519323|O1|Outcome|Vemurafenib 720 mg|Participants enrolled in the first cohort received vemurafenib 720 mg by mouth BID.
115497|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115498|NCT01519323|E1|Reported Event|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
115499|NCT01519284|B6|Baseline|Total|Total of all reporting groups
115500|NCT01519284|B5|Baseline|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose~Entacapone: Entacapone 200 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
115501|NCT01519284|B4|Baseline|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg"
115502|NCT01519284|B3|Baseline|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg"
115503|NCT01519284|B2|Baseline|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
115504|NCT01519284|B1|Baseline|Group 1|"Placebo at all the dosing times~Placebo: placebo (four times a day)"
115505|NCT01519284|P5|Participant Flow|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115506|NCT01519284|P4|Participant Flow|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
115507|NCT01519284|P3|Participant Flow|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115508|NCT01519284|P2|Participant Flow|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115509|NCT01519284|P1|Participant Flow|Group 1|Placebo at all the dosing times
115510|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115511|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
115512|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115513|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115514|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
115515|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115516|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
115517|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115518|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115519|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
115520|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115521|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
115522|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115523|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115524|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
118852|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
115527|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115528|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115529|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
115530|NCT01519284|E5|Reported Event|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
115531|NCT01519284|E4|Reported Event|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
115532|NCT01519284|E3|Reported Event|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115533|NCT01519284|E2|Reported Event|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
115534|NCT01519284|E1|Reported Event|Group 1|Placebo at all the dosing times
115535|NCT01519245|B3|Baseline|Total|Total of all reporting groups
115536|NCT01519245|B2|Baseline|Placebo|Normal saline (70mL)
115537|NCT01519245|B1|Baseline|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115538|NCT01519245|P2|Participant Flow|Placebo|Normal saline (70mL)
115539|NCT01519245|P1|Participant Flow|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115540|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
115541|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115542|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
115543|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115544|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
115545|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115546|NCT01519245|O2|Outcome|Placebo|"Normal saline (70mL)~Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)"
115547|NCT01519245|O1|Outcome|Trial Drug|"Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)~Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)"
115548|NCT01519245|E2|Reported Event|Placebo|Normal saline (70mL)
115549|NCT01519245|E1|Reported Event|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
115550|NCT01519206|B1|Baseline|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115551|NCT01519206|P1|Participant Flow|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115552|NCT01519206|O3|Outcome|Treated Subjects PSQ Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115553|NCT01519206|O2|Outcome|Treated Subjects PSQ Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115554|NCT01519206|O1|Outcome|Treated Subjects PSQ Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115555|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115556|NCT01519206|O4|Outcome|Treated Subjects GAIS Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115557|NCT01519206|O3|Outcome|Treated Subjects GAIS Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115558|NCT01519206|O2|Outcome|Treated Subjects GAIS Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115559|NCT01519206|O1|Outcome|Treated Subjects GAIS Data - 60 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115560|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115561|NCT01519206|E1|Reported Event|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
115562|NCT01519167|B3|Baseline|Total|Total of all reporting groups
115563|NCT01519167|B2|Baseline|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115564|NCT01519167|B1|Baseline|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115565|NCT01519167|P2|Participant Flow|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115566|NCT01519167|P1|Participant Flow|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115567|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115568|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115569|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115570|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115571|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115578|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115579|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115580|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115581|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115582|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115583|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115584|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115585|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115586|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115587|NCT01519167|E2|Reported Event|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
115588|NCT01519167|E1|Reported Event|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
115589|NCT01519089|B3|Baseline|Total|Total of all reporting groups
115590|NCT01519089|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115591|NCT01519089|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115592|NCT01519089|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115593|NCT01519089|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115594|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115595|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115596|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115597|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115598|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115599|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115600|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115601|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115602|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115603|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115604|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115605|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115606|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115607|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115608|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115609|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115610|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115611|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115612|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115613|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115614|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115615|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115616|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115617|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115618|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115619|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115620|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115621|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115622|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115623|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115624|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115625|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115626|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115627|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115628|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115629|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115630|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115631|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115632|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115633|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115634|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115635|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115636|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115637|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115638|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115639|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115640|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115641|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115642|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115643|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115644|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115645|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115646|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115647|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115648|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115649|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115650|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115651|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115652|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115653|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115654|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115655|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115656|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115657|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115658|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115659|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115660|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115661|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115662|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115663|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115664|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115665|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115667|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115668|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115669|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115670|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115671|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115672|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115673|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115674|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115675|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115676|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115677|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115678|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115679|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115680|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115681|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115682|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115683|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115684|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115685|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115686|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115687|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115688|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115689|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115690|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115691|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115692|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115693|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115694|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115695|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115696|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115697|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115698|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115699|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115700|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115701|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115702|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115703|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115704|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115705|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
115706|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115707|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115708|NCT01519089|E3|Reported Event|Total|(=sum across Arm/Groups)
115709|NCT01519089|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115710|NCT01519089|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
115711|NCT01518946|B3|Baseline|Total|Total of all reporting groups
115712|NCT01518946|B2|Baseline|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
115713|NCT01518946|B1|Baseline|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
115714|NCT01518946|P3|Participant Flow|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
115715|NCT01518946|P2|Participant Flow|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
115716|NCT01518946|P1|Participant Flow|Midodrine HCl (Open-label Phase)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
115717|NCT01518946|O2|Outcome|Midodrine HCl|dose at the subject's current dose level
115718|NCT01518946|O1|Outcome|Placebo|single dose of matching placebo
115719|NCT01518946|E3|Reported Event|Midodrine HCl (Randomized Phase)|dose at the subject's current dose level
115720|NCT01518946|E2|Reported Event|Placebo (Randomized Phase)|single dose of matching placebo
115721|NCT01518946|E1|Reported Event|Midodrine HCl (Open-label Phase)|dose at the subject's current dose level
115722|NCT01518530|B1|Baseline|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
115723|NCT01518530|P1|Participant Flow|Chronic Neck Pain Patients Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
115724|NCT01518530|O1|Outcome|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
115725|NCT01518530|E1|Reported Event|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
115726|NCT01518322|B1|Baseline|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
115727|NCT01518322|P1|Participant Flow|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
115728|NCT01518322|O1|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
115729|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
115730|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
115731|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
115732|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high
115733|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
115734|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
115735|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
115736|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
115737|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
115738|NCT01518322|E1|Reported Event|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
115739|NCT01518270|B1|Baseline|Healthy Females|Participant's eyelashes were photographed at one study visit.
115740|NCT01518270|P1|Participant Flow|Healthy Females|Participant's eyelashes were photographed at one study visit.
115741|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
115742|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
115743|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
115744|NCT01518270|E1|Reported Event|Healthy Females|Healthy Females
115745|NCT01518257|B3|Baseline|Total|Total of all reporting groups
115746|NCT01518257|B2|Baseline|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115747|NCT01518257|B1|Baseline|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115748|NCT01518257|P2|Participant Flow|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115749|NCT01518257|P1|Participant Flow|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115750|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115751|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115752|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115753|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115754|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115755|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115756|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115757|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115758|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115759|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115760|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115761|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115762|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115763|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115764|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115765|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115766|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115767|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115768|NCT01518257|E2|Reported Event|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
115769|NCT01518257|E1|Reported Event|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
115770|NCT01518244|B1|Baseline|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
115771|NCT01518244|P1|Participant Flow|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
115772|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
115773|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
115774|NCT01518244|E1|Reported Event|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
115775|NCT01518192|B4|Baseline|Total|Total of all reporting groups
115776|NCT01518192|B3|Baseline|Controls|To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
115777|NCT01518192|B2|Baseline|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
115778|NCT01518192|B1|Baseline|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
115779|NCT01518192|P3|Participant Flow|Controls|patients' family members or friends without a history of Lyme disease
116034|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
115780|NCT01518192|P2|Participant Flow|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
115781|NCT01518192|P1|Participant Flow|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
115782|NCT01518192|O2|Outcome|Controls|controls with selected subjective symptoms at 12 months post inclusion
115783|NCT01518192|O1|Outcome|Patients|patients with selected subjective symptoms at 12 months post inclusion
115784|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since erythema migrans at 12 months post inclusion
115785|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 12 months post inclusion
115786|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
115787|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
115788|NCT01518192|O2|Outcome|Cefuroximew Axetil|cefuroxime axetil 500 mg twice daily for 15 days
115789|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
115790|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
115791|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
115792|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
115793|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
115794|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since enrollment at 6 months post inclusion
115795|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 6 months post inclusion
115796|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
115797|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
115798|NCT01518192|E3|Reported Event|Controls|patients' family members or friends without a history of Lyme disease
115799|NCT01518192|E2|Reported Event|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
115800|NCT01518192|E1|Reported Event|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
115801|NCT01518153|B1|Baseline|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115802|NCT01518153|P3|Participant Flow|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115803|NCT01518153|P2|Participant Flow|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115804|NCT01518153|P1|Participant Flow|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
115805|NCT01518153|O1|Outcome|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115857|NCT01517750|P2|Participant Flow|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
116035|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
115806|NCT01518153|O2|Outcome|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115807|NCT01518153|O1|Outcome|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115808|NCT01518153|E3|Reported Event|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115809|NCT01518153|E2|Reported Event|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
115810|NCT01518153|E1|Reported Event|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
115811|NCT01517984|B4|Baseline|Total|Total of all reporting groups
115812|NCT01517984|B3|Baseline|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115813|NCT01517984|B2|Baseline|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115814|NCT01517984|B1|Baseline|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
115815|NCT01517984|P4|Participant Flow|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115816|NCT01517984|P3|Participant Flow|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115858|NCT01517750|P1|Participant Flow|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
115817|NCT01517984|P2|Participant Flow|Transplanted, Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
115818|NCT01517984|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol.
115819|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115820|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115821|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115822|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115823|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115824|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115825|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115826|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115859|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
115860|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
115861|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
115827|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115828|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115829|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115830|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115831|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115832|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115833|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115834|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115835|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115862|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
115863|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
115864|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
115865|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
115836|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115837|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115838|NCT01517984|E3|Reported Event|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
115839|NCT01517984|E2|Reported Event|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
115840|NCT01517984|E1|Reported Event|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
115841|NCT01517893|B3|Baseline|Total|Total of all reporting groups
115842|NCT01517893|B2|Baseline|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
115843|NCT01517893|B1|Baseline|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
115844|NCT01517893|P2|Participant Flow|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
115845|NCT01517893|P1|Participant Flow|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
115846|NCT01517893|O2|Outcome|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
115847|NCT01517893|O1|Outcome|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
115848|NCT01517893|E2|Reported Event|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
115849|NCT01517893|E1|Reported Event|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
115850|NCT01517750|B5|Baseline|Total|Total of all reporting groups
115851|NCT01517750|B4|Baseline|APAP Without Humidification + High Risks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115852|NCT01517750|B3|Baseline|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115853|NCT01517750|B2|Baseline|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115854|NCT01517750|B1|Baseline|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115855|NCT01517750|P4|Participant Flow|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
115856|NCT01517750|P3|Participant Flow|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
115866|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
116036|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
115867|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115868|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115869|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115870|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115871|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115872|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115873|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115874|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115875|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115876|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115877|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115878|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115879|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115880|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115881|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115882|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115883|NCT01517750|E4|Reported Event|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115884|NCT01517750|E3|Reported Event|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
115885|NCT01517750|E2|Reported Event|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115886|NCT01517750|E1|Reported Event|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
115887|NCT01517529|B1|Baseline|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
115888|NCT01517529|P1|Participant Flow|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
115889|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
115890|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
115891|NCT01517529|E1|Reported Event|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
115892|NCT01517412|B3|Baseline|Total|Total of all reporting groups
115893|NCT01517412|B2|Baseline|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115894|NCT01517412|B1|Baseline|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115895|NCT01517412|P2|Participant Flow|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115896|NCT01517412|P1|Participant Flow|Lixisenatide Main Meal|Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115897|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115898|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115899|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115900|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115901|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115902|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115903|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115904|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115905|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115906|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115907|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115908|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115909|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115910|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115911|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115912|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115913|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115914|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115915|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115916|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115917|NCT01517412|E2|Reported Event|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115918|NCT01517412|E1|Reported Event|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
115919|NCT01517373|B6|Baseline|Total|Total of all reporting groups
115920|NCT01517373|B5|Baseline|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115921|NCT01517373|B4|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115922|NCT01517373|B3|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115923|NCT01517373|B2|Baseline|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115924|NCT01517373|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115925|NCT01517373|P6|Participant Flow|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115926|NCT01517373|P5|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115927|NCT01517373|P4|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115928|NCT01517373|P3|Participant Flow|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115929|NCT01517373|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115930|NCT01517373|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
115931|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115932|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115933|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115934|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115935|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115936|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115937|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115938|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115939|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115940|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115941|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115942|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115943|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115944|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115945|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115946|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115947|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115948|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115949|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115950|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115951|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115952|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115953|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115954|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115955|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115956|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115957|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115958|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115959|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115960|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115961|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115962|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115963|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115964|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115965|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115966|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115967|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115968|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115969|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115970|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115971|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115972|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115973|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115974|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115975|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115976|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115977|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115978|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115979|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115980|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115981|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115982|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115983|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115984|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115985|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115986|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115987|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115988|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115989|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115990|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115991|NCT01517373|E6|Reported Event|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115992|NCT01517373|E5|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115993|NCT01517373|E4|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115994|NCT01517373|E3|Reported Event|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115995|NCT01517373|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
115996|NCT01517373|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
115997|NCT01517295|B3|Baseline|Total|Total of all reporting groups
115998|NCT01517295|B2|Baseline|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
115999|NCT01517295|B1|Baseline|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116000|NCT01517295|P2|Participant Flow|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116001|NCT01517295|P1|Participant Flow|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116002|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116003|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116004|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116005|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116006|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116007|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116008|NCT01517295|E2|Reported Event|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116009|NCT01517295|E1|Reported Event|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
116010|NCT01517282|B5|Baseline|Total|Total of all reporting groups
116011|NCT01517282|B4|Baseline|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116012|NCT01517282|B3|Baseline|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116013|NCT01517282|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116014|NCT01517282|B1|Baseline|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116015|NCT01517282|P4|Participant Flow|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116016|NCT01517282|P3|Participant Flow|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116017|NCT01517282|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116018|NCT01517282|P1|Participant Flow|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116019|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116020|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116021|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116022|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116023|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116024|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116025|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116026|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116027|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116028|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116029|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116030|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116031|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116032|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116033|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
118853|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
116037|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116038|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116039|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116040|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116041|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116042|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116043|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116044|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116045|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116046|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116047|NCT01517282|E4|Reported Event|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
116048|NCT01517282|E3|Reported Event|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116049|NCT01517282|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116050|NCT01517282|E1|Reported Event|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
116051|NCT01517178|B1|Baseline|Intention-to-treat Analysis Set|
116052|NCT01517178|P2|Participant Flow|New Ostomy Base Plate - Standard Care|Subjects first test New ostomy base plate then Standard Care.
116053|NCT01517178|P1|Participant Flow|Standard Care - New Ostomy Base Plate|Subjects first test Standard Care then New ostomy base plate.
116054|NCT01517178|O2|Outcome|New Ostomy Base Plate|
116055|NCT01517178|O1|Outcome|Standard Care Base Plate|
116056|NCT01517178|E2|Reported Event|New Ostomy Base Plate|Safety population includes subjects allocated to run-in period and test period.
116057|NCT01517178|E1|Reported Event|Standard Care Base Plate|Safety population includes subjects allocated to test period (no run-in period)
116058|NCT01517074|B1|Baseline|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
116059|NCT01517074|P1|Participant Flow|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
116060|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116061|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116062|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116074|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
135195|NCT01433263|O1|Outcome|30mg/kg BYM338|
116063|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116064|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116065|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116066|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116067|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
116068|NCT01517074|E1|Reported Event|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
116069|NCT01516970|B3|Baseline|Total|Total of all reporting groups
116070|NCT01516970|B2|Baseline|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
116071|NCT01516970|B1|Baseline|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116072|NCT01516970|P2|Participant Flow|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
116073|NCT01516970|P1|Participant Flow|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116095|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116096|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
135196|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
116075|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116076|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116077|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116078|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116079|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116080|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116081|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116082|NCT01516970|E2|Reported Event|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
116083|NCT01516970|E1|Reported Event|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
116084|NCT01516892|B1|Baseline|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116085|NCT01516892|P1|Participant Flow|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116086|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116087|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116088|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116089|NCT01516892|E1|Reported Event|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
116090|NCT01516879|B3|Baseline|Total|Total of all reporting groups
116091|NCT01516879|B2|Baseline|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116092|NCT01516879|B1|Baseline|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116093|NCT01516879|P2|Participant Flow|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116094|NCT01516879|P1|Participant Flow|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116097|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116098|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116099|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116100|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116101|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116102|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116103|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116104|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116105|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116106|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116107|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116108|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116109|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116110|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116111|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116112|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116113|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116114|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116115|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116116|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116117|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116118|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116119|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116120|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116121|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116122|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116123|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116124|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116125|NCT01516879|E2|Reported Event|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116126|NCT01516879|E1|Reported Event|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
116127|NCT01516749|B1|Baseline|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116128|NCT01516749|P1|Participant Flow|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116129|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116130|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116131|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116132|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116189|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
135197|NCT01433263|O1|Outcome|30mg/kg BYM338|
116133|NCT01516749|E1|Reported Event|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
116134|NCT01516632|B3|Baseline|Total|Total of all reporting groups
116135|NCT01516632|B2|Baseline|The Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
116136|NCT01516632|B1|Baseline|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
116137|NCT01516632|P2|Participant Flow|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
116138|NCT01516632|P1|Participant Flow|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
116139|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
116140|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
116141|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
116142|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
116143|NCT01516632|O2|Outcome|Attention Matched Control|"Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking. Messages sent on the same schedule as the intervention group.~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
116144|NCT01516632|O1|Outcome|Smoking Cesssation Via Text Messaging|"The 6-week smoking cessation program~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
116190|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116191|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116192|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116145|NCT01516632|E2|Reported Event|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
116146|NCT01516632|E1|Reported Event|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
116147|NCT01516268|B3|Baseline|Total|Total of all reporting groups
116148|NCT01516268|B2|Baseline|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
116149|NCT01516268|B1|Baseline|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
116150|NCT01516268|P2|Participant Flow|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
116151|NCT01516268|P1|Participant Flow|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
116152|NCT01516268|O2|Outcome|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
116153|NCT01516268|O1|Outcome|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
116154|NCT01516268|E2|Reported Event|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
116155|NCT01516268|E1|Reported Event|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
116156|NCT01516034|B1|Baseline|Treatment|Cupola tattoo removal treatment
116157|NCT01516034|P1|Participant Flow|Treatment|Cupola tattoo removal treatment
116158|NCT01516034|O1|Outcome|Treatment|Cupola tattoo removal treatment
116159|NCT01516034|E1|Reported Event|Treatment|Cupola tattoo removal treatment
116160|NCT01516008|B4|Baseline|Total|Total of all reporting groups
116161|NCT01516008|B3|Baseline|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116162|NCT01516008|B2|Baseline|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116163|NCT01516008|B1|Baseline|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116164|NCT01516008|P3|Participant Flow|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116165|NCT01516008|P2|Participant Flow|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116166|NCT01516008|P1|Participant Flow|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116167|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116168|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116169|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116170|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116171|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116172|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116173|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116174|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116175|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116176|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116177|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116178|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116179|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116180|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116181|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116182|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116183|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116184|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116185|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116186|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116187|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116188|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116193|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116194|NCT01516008|E3|Reported Event|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116195|NCT01516008|E2|Reported Event|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
116196|NCT01516008|E1|Reported Event|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
116197|NCT01515943|B4|Baseline|Total|Total of all reporting groups
116198|NCT01515943|B3|Baseline|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
116199|NCT01515943|B2|Baseline|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr"
116200|NCT01515943|B1|Baseline|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
116201|NCT01515943|P3|Participant Flow|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
116202|NCT01515943|P2|Participant Flow|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times."
116203|NCT01515943|P1|Participant Flow|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
116204|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116205|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116206|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116238|NCT01515865|E4|Reported Event|Placebo - Randomized (Part C)|over-encapsulated randomized matching placebo
116207|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116208|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116209|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116210|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116211|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116212|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116213|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116214|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116215|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116216|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116217|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116218|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116219|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116220|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116221|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116222|NCT01515943|E3|Reported Event|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116223|NCT01515943|E2|Reported Event|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
116224|NCT01515943|E1|Reported Event|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
116225|NCT01515891|B1|Baseline|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116226|NCT01515891|P1|Participant Flow|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116227|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116228|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116229|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116230|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116231|NCT01515891|E1|Reported Event|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
116232|NCT01515865|B1|Baseline|Enrolled Population|
116233|NCT01515865|P3|Participant Flow|Placebo - (Randomized)|On Day 16 subjects received matching placebo.
116234|NCT01515865|P2|Participant Flow|Midodrine HCl - (Randomized)|On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
116235|NCT01515865|P1|Participant Flow|Midodrine HCl - (Open-label)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
116236|NCT01515865|O2|Outcome|Placebo|Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
116237|NCT01515865|O1|Outcome|Midodrine HCl|Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
116239|NCT01515865|E3|Reported Event|Midodrine HCl - Randomized (Part C)|over-encapsulated randomized dose (Part C) at subjects current dose level
116240|NCT01515865|E2|Reported Event|Midodrine HCl - Open-label (Part B)|open-label study-supplied (Part B) dose at subjects current dose level
116241|NCT01515865|E1|Reported Event|Midodrine HCl - Open-label (Part A)|dose at the subjects current dose level
116242|NCT01515696|B3|Baseline|Total|Total of all reporting groups
116243|NCT01515696|B2|Baseline|Sterile Water|infants receive 9ml/kg sterile water
116244|NCT01515696|B1|Baseline|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
116245|NCT01515696|P2|Participant Flow|Sterile Water|infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
116246|NCT01515696|P1|Participant Flow|Gastrografin|infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
116247|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
116248|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
116249|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
116250|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
116251|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
116252|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
116253|NCT01515696|E2|Reported Event|Sterile Water|infants receive 9ml/kg sterile water
116254|NCT01515696|E1|Reported Event|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
116255|NCT01515657|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug under the study protocol.
116256|NCT01515657|P3|Participant Flow|EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets|"First Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days"
116257|NCT01515657|P2|Participant Flow|IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin|"First Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
116258|NCT01515657|P1|Participant Flow|PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days"
116259|NCT01515657|O3|Outcome|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
116260|NCT01515657|O2|Outcome|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
116261|NCT01515657|O1|Outcome|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
116262|NCT01515657|E3|Reported Event|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
116263|NCT01515657|E2|Reported Event|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
116264|NCT01515657|E1|Reported Event|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
116265|NCT01515566|B3|Baseline|Total|Total of all reporting groups
116266|NCT01515566|B2|Baseline|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
116267|NCT01515566|B1|Baseline|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
116268|NCT01515566|P2|Participant Flow|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
116269|NCT01515566|P1|Participant Flow|Fentanyl|Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
116270|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
116271|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
116272|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
116273|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
116274|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
116275|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
116276|NCT01515566|E2|Reported Event|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
116277|NCT01515566|E1|Reported Event|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
116278|NCT01515540|B3|Baseline|Total|Total of all reporting groups
116279|NCT01515540|B2|Baseline|Control|placebo patch
116280|NCT01515540|B1|Baseline|Lidocaine|5% lidoderm patch
116288|NCT01515488|B2|Baseline|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116289|NCT01515488|B1|Baseline|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116290|NCT01515488|P2|Participant Flow|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116291|NCT01515488|P1|Participant Flow|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116292|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116293|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116294|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116295|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116296|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116297|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116298|NCT01515488|E2|Reported Event|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
116299|NCT01515488|E1|Reported Event|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
116300|NCT01515423|B3|Baseline|Total|Total of all reporting groups
116301|NCT01515423|B2|Baseline|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116302|NCT01515423|B1|Baseline|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116303|NCT01515423|P3|Participant Flow|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116304|NCT01515423|P2|Participant Flow|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116305|NCT01515423|P1|Participant Flow|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
116306|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116307|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116308|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116309|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116310|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116337|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
118854|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
116311|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116312|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116313|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116314|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116315|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116316|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116317|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116318|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116319|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116320|NCT01515423|E3|Reported Event|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
116321|NCT01515423|E2|Reported Event|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
116322|NCT01515423|E1|Reported Event|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
116323|NCT01515410|B1|Baseline|Overall Study|DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
116324|NCT01515410|P2|Participant Flow|Sinemet IR First, Then DM-1992|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
116325|NCT01515410|P1|Participant Flow|DM-1992 First, Then Sinemet IR|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
116326|NCT01515410|O2|Outcome|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
116327|NCT01515410|O1|Outcome|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
116328|NCT01515410|E2|Reported Event|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
116329|NCT01515410|E1|Reported Event|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
116330|NCT01515345|B3|Baseline|Total|Total of all reporting groups
116331|NCT01515345|B2|Baseline|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
116332|NCT01515345|B1|Baseline|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116333|NCT01515345|P2|Participant Flow|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
116334|NCT01515345|P1|Participant Flow|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116335|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
116336|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116790|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116338|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116339|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
116340|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116341|NCT01515345|E2|Reported Event|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
116342|NCT01515345|E1|Reported Event|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
116343|NCT01515306|B3|Baseline|Total|Total of all reporting groups
116344|NCT01515306|B2|Baseline|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
116345|NCT01515306|B1|Baseline|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
116346|NCT01515306|P2|Participant Flow|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
116347|NCT01515306|P1|Participant Flow|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
116348|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
116349|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
116350|NCT01515306|O1|Outcome|Part B: Ramucirumab (IMC-1121B) (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
116351|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
116352|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
116353|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
116354|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
116355|NCT01515306|E2|Reported Event|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
116356|NCT01515306|E1|Reported Event|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
116357|NCT01514864|B3|Baseline|Total|Total of all reporting groups
116358|NCT01514864|B2|Baseline|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116359|NCT01514864|B1|Baseline|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116360|NCT01514864|P2|Participant Flow|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116361|NCT01514864|P1|Participant Flow|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116398|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
135198|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
116362|NCT01514864|O1|Outcome|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
116363|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116364|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116365|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116366|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116367|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116368|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116369|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116370|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116371|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116372|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116373|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116374|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
116375|NCT01514864|E1|Reported Event|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
116376|NCT01514760|B1|Baseline|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116377|NCT01514760|P1|Participant Flow|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan : The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116378|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116399|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
116400|NCT01514513|E2|Reported Event|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
116379|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116380|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116381|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116382|NCT01514760|E1|Reported Event|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
116383|NCT01514734|B1|Baseline|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
116384|NCT01514734|P1|Participant Flow|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
116385|NCT01514734|O1|Outcome|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
116386|NCT01514734|E1|Reported Event|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
116387|NCT01514630|B1|Baseline|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
116388|NCT01514630|P1|Participant Flow|Creatine Monohydrate|14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
116389|NCT01514630|O1|Outcome|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
116390|NCT01514630|E1|Reported Event|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
116391|NCT01514513|B3|Baseline|Total|Total of all reporting groups
116392|NCT01514513|B2|Baseline|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
116393|NCT01514513|B1|Baseline|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
116394|NCT01514513|P2|Participant Flow|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
116395|NCT01514513|P1|Participant Flow|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
116396|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
116397|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
135199|NCT01433263|O1|Outcome|30mg/kg BYM338|
116401|NCT01514513|E1|Reported Event|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
116402|NCT01514461|B4|Baseline|Total|Total of all reporting groups
116403|NCT01514461|B3|Baseline|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116404|NCT01514461|B2|Baseline|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116405|NCT01514461|B1|Baseline|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116406|NCT01514461|P3|Participant Flow|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116407|NCT01514461|P2|Participant Flow|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116408|NCT01514461|P1|Participant Flow|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116409|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116410|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116411|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116412|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116413|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116414|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116415|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116791|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116416|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116417|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116418|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116419|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116420|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116421|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116422|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116423|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116424|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116425|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116426|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116427|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116428|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116476|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116739|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116429|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116430|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116431|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116432|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116433|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116434|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116435|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116436|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116437|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116438|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116439|NCT01514461|O2|Outcome|LCQ908 20mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116440|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116441|NCT01514461|E3|Reported Event|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116477|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116786|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116792|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116442|NCT01514461|E2|Reported Event|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.
116443|NCT01514461|E1|Reported Event|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
116444|NCT01514422|B1|Baseline|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
116445|NCT01514422|P1|Participant Flow|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
116446|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
116447|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
116448|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
116449|NCT01514422|E1|Reported Event|Minocycline|Minocycline for 8 weeks
116450|NCT01514318|B1|Baseline|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116451|NCT01514318|P1|Participant Flow|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116452|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116453|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116454|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116455|NCT01514318|E1|Reported Event|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
116456|NCT01514292|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
116457|NCT01514292|P1|Participant Flow|CGM Device|Dexcom CGM Device Wearing for up to 7 days
116458|NCT01514292|O1|Outcome|Real Time Continous Glucose Monitoring System|Real Time Continous Glucose Monitoring System Wearing for up to 7 days
116459|NCT01514292|E1|Reported Event|CGM Device|Dexcom CGM Device Wearing for up to 7 days
116460|NCT01514240|B3|Baseline|Total|Total of all reporting groups
116461|NCT01514240|B2|Baseline|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116462|NCT01514240|B1|Baseline|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116463|NCT01514240|P2|Participant Flow|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116464|NCT01514240|P1|Participant Flow|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116465|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116466|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116467|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116468|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116469|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116470|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116471|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116472|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116473|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116474|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116475|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
135200|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
116478|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116479|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116480|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116481|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116482|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116483|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116484|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116485|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116486|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116487|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116488|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116489|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116490|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116491|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116492|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116493|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116494|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116495|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116496|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116497|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116498|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116499|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116500|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116501|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116502|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116503|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116504|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116614|NCT01513590|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116505|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116506|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116507|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116508|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116509|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116510|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116511|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116512|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116513|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116514|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116515|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116516|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116517|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116518|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116519|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116520|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116521|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116522|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116523|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116524|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116525|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116526|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116527|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116528|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116529|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116530|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116531|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116615|NCT01513590|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116532|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116533|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116534|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116535|NCT01514240|E2|Reported Event|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
116536|NCT01514240|E1|Reported Event|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
116537|NCT01514136|B3|Baseline|Total|Total of all reporting groups
116538|NCT01514136|B2|Baseline|Flat Product Users|Subjects who usually use a flat product
116539|NCT01514136|B1|Baseline|Convex Product Users|Subjects who usually use a convex product
116540|NCT01514136|P8|Participant Flow|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
116541|NCT01514136|P7|Participant Flow|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
116542|NCT01514136|P6|Participant Flow|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
116543|NCT01514136|P5|Participant Flow|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
116544|NCT01514136|P4|Participant Flow|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D was a newly developed concept by Coloplast A/S for the first round."
116545|NCT01514136|P3|Participant Flow|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C was a newly developed concept by Coloplast A/S for the first round."
116546|NCT01514136|P2|Participant Flow|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B was a newly developed concept by Coloplast A/S for the first round."
116547|NCT01514136|P1|Participant Flow|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A was a newly developed concept by Coloplast A/S for the first round."
116548|NCT01514136|O16|Outcome|Test D* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
116549|NCT01514136|O15|Outcome|Test C* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
116550|NCT01514136|O14|Outcome|Test B* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
116551|NCT01514136|O13|Outcome|Test A* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
116552|NCT01514136|O12|Outcome|Test D - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
116553|NCT01514136|O11|Outcome|Test C - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
116554|NCT01514136|O10|Outcome|Test B - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
116555|NCT01514136|O9|Outcome|Test A - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
116556|NCT01514136|O8|Outcome|Test D* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
116557|NCT01514136|O7|Outcome|Test C* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
116558|NCT01514136|O6|Outcome|Test B* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
116559|NCT01514136|O5|Outcome|Test A* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
116560|NCT01514136|O4|Outcome|Test D - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
116561|NCT01514136|O3|Outcome|Test C - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
116562|NCT01514136|O2|Outcome|Test B - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
116563|NCT01514136|O1|Outcome|Test A - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
116564|NCT01514136|E8|Reported Event|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
116565|NCT01514136|E7|Reported Event|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
116566|NCT01514136|E6|Reported Event|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
116567|NCT01514136|E5|Reported Event|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
116568|NCT01514136|E4|Reported Event|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D was a newly developed concept by Coloplast A/S for the first round."
116569|NCT01514136|E3|Reported Event|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C was a newly developed concept by Coloplast A/S for the first round."
116787|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116570|NCT01514136|E2|Reported Event|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B was a newly developed concept by Coloplast A/S for the first round."
116571|NCT01514136|E1|Reported Event|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A was a newly developed concept by Coloplast A/S for the first round."
116572|NCT01513902|B4|Baseline|Total|Total of all reporting groups
116573|NCT01513902|B3|Baseline|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116574|NCT01513902|B2|Baseline|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116575|NCT01513902|B1|Baseline|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116576|NCT01513902|P3|Participant Flow|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116577|NCT01513902|P2|Participant Flow|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116578|NCT01513902|P1|Participant Flow|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116579|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116580|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116581|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116582|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116583|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116584|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116585|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116586|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116587|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116588|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116589|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116590|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116591|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116592|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116593|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116594|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116595|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116596|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116597|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116598|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116599|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116600|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116601|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116602|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116603|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116604|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116605|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116606|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116607|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116608|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116609|NCT01513902|E3|Reported Event|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116610|NCT01513902|E2|Reported Event|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
116611|NCT01513902|E1|Reported Event|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
116612|NCT01513590|B3|Baseline|Total|Total of all reporting groups
116613|NCT01513590|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116616|NCT01513590|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116617|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116618|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116619|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116620|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116621|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116622|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116623|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116624|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116625|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116626|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116627|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116628|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116629|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116630|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116631|NCT01513590|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
116632|NCT01513590|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
116633|NCT01513473|B3|Baseline|Total|Total of all reporting groups
116634|NCT01513473|B2|Baseline|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116635|NCT01513473|B1|Baseline|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116636|NCT01513473|P2|Participant Flow|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116637|NCT01513473|P1|Participant Flow|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116638|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116639|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116640|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116735|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
135201|NCT01433263|O1|Outcome|30mg/kg BYM338|
116641|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116642|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116643|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116644|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116645|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116646|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116647|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116648|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116649|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116650|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116651|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116652|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116653|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116654|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116655|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116736|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116737|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116656|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116657|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116658|NCT01513473|E2|Reported Event|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
116659|NCT01513473|E1|Reported Event|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
116660|NCT01513460|B4|Baseline|Total|Total of all reporting groups
116661|NCT01513460|B3|Baseline|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116662|NCT01513460|B2|Baseline|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116663|NCT01513460|B1|Baseline|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116664|NCT01513460|P3|Participant Flow|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116665|NCT01513460|P2|Participant Flow|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116666|NCT01513460|P1|Participant Flow|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116667|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116668|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116669|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116670|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116738|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116788|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116671|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116672|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116673|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116674|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116675|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116676|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116677|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116678|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116679|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116680|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116681|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116682|NCT01513460|O2|Outcome|NVA237/Tiotropium+Flu/Sal|NVA237+Flu/Sal and Tiotropium+Flu/Sal arms
116683|NCT01513460|O1|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116684|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116685|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116789|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116686|NCT01513460|E3|Reported Event|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116687|NCT01513460|E2|Reported Event|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116688|NCT01513460|E1|Reported Event|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
116689|NCT01513447|B3|Baseline|Total|Total of all reporting groups
116690|NCT01513447|B2|Baseline|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116691|NCT01513447|B1|Baseline|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116692|NCT01513447|P2|Participant Flow|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116693|NCT01513447|P1|Participant Flow|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116694|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116695|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116696|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116697|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116698|NCT01513447|E2|Reported Event|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116699|NCT01513447|E1|Reported Event|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
116700|NCT01513330|B1|Baseline|Entire Study Population|Entire study population = all participants enrolled in the study
116701|NCT01513330|P2|Participant Flow|First Standard Care, Then SenSura Mio|The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
116702|NCT01513330|P1|Participant Flow|First SenSura Mio, Then Standard Care|The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
116703|NCT01513330|O2|Outcome|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
116704|NCT01513330|O1|Outcome|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
116705|NCT01513330|E2|Reported Event|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
116706|NCT01513330|E1|Reported Event|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
116707|NCT01513317|B3|Baseline|Total|Total of all reporting groups
116708|NCT01513317|B2|Baseline|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116709|NCT01513317|B1|Baseline|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116710|NCT01513317|P2|Participant Flow|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116711|NCT01513317|P1|Participant Flow|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116712|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116713|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116714|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116715|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116716|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116717|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116718|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116719|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116720|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116721|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116722|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116723|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116724|NCT01513317|E2|Reported Event|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116725|NCT01513317|E1|Reported Event|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
116726|NCT01513291|B3|Baseline|Total|Total of all reporting groups
116727|NCT01513291|B2|Baseline|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116728|NCT01513291|B1|Baseline|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116729|NCT01513291|P5|Participant Flow|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116730|NCT01513291|P4|Participant Flow|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116731|NCT01513291|P3|Participant Flow|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
116732|NCT01513291|P2|Participant Flow|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116733|NCT01513291|P1|Participant Flow|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116734|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
135202|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
116740|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116741|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116742|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
116743|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116744|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116745|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116746|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116747|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
116748|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116749|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116750|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116751|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116752|NCT01513291|E5|Reported Event|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116753|NCT01513291|E4|Reported Event|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
116754|NCT01513291|E3|Reported Event|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
116755|NCT01513291|E2|Reported Event|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
116756|NCT01513291|E1|Reported Event|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
116757|NCT01513239|B4|Baseline|Total|Total of all reporting groups
116758|NCT01513239|B3|Baseline|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116759|NCT01513239|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116760|NCT01513239|B1|Baseline|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116761|NCT01513239|P3|Participant Flow|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116762|NCT01513239|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116763|NCT01513239|P1|Participant Flow|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116764|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116765|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116766|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116767|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116768|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116769|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116770|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116771|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116772|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116773|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116774|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116775|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116776|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116777|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116778|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116779|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116780|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116781|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116782|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116783|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116784|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116785|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116793|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116794|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116795|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116796|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116797|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116798|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116799|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116800|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116801|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116802|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116803|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116804|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116805|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
116806|NCT01513239|E4|Reported Event|MK-3415 + SOC|Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
116807|NCT01513239|E3|Reported Event|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
116808|NCT01513239|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
116809|NCT01513239|E1|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
116810|NCT01513148|B3|Baseline|Total|Total of all reporting groups
116811|NCT01513148|B2|Baseline|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
116812|NCT01513148|B1|Baseline|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
116813|NCT01513148|P2|Participant Flow|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
116814|NCT01513148|P1|Participant Flow|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
116815|NCT01513148|O14|Outcome|Sham Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116816|NCT01513148|O13|Outcome|Sham Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116817|NCT01513148|O12|Outcome|Sham Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116818|NCT01513148|O11|Outcome|Sham Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116819|NCT01513148|O10|Outcome|Sham Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116820|NCT01513148|O9|Outcome|Sham Temp Time 0|Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116821|NCT01513148|O8|Outcome|Sham Temp Pretreatment|Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve
116822|NCT01513148|O7|Outcome|Light Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116823|NCT01513148|O6|Outcome|Light Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116824|NCT01513148|O5|Outcome|Light Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116825|NCT01513148|O4|Outcome|Light Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116826|NCT01513148|O3|Outcome|Light Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
116827|NCT01513148|O2|Outcome|Light Temp Time 0|Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve
116828|NCT01513148|O1|Outcome|Light Temp Pretreatment|Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve
116829|NCT01513148|O14|Outcome|Sham NPL Pretreatment|NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)
116830|NCT01513148|O13|Outcome|Sham NPL Time 10|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes
116831|NCT01513148|O12|Outcome|Sham NPL Time 8|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes
116832|NCT01513148|O11|Outcome|Sham NPL Time 6|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes
116833|NCT01513148|O10|Outcome|Sham NPL Time 4|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes
116834|NCT01513148|O9|Outcome|Sham NPL Time 2|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes
116835|NCT01513148|O8|Outcome|Sham NPL Time 0|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes
116836|NCT01513148|O7|Outcome|Light NPL Time 10|NPL for treatment group (Superluminous diode light therapy) at time 10 minutes
116837|NCT01513148|O6|Outcome|Light NPL Time 8|NPL for treatment group (Superluminous diode light therapy) at time 8 minutes
116838|NCT01513148|O5|Outcome|Light NPL Time 6|NPL for treatment group (Superluminous diode light therapy) at time 6 minutes
116839|NCT01513148|O4|Outcome|Light NPL Time 4|NPL for treatment group (Superluminous diode light therapy) at time 4 minutes
116840|NCT01513148|O3|Outcome|Light NPL Time 2|NPL for treatment group (Superluminous diode light therapy) at time 2 minutes
116841|NCT01513148|O2|Outcome|Light NPL Time 0|NPL for treatment group (Superluminous diode light therapy) at time 0 minutes
118855|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing
116842|NCT01513148|O1|Outcome|Light NPL Pre-treatment|NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)
116843|NCT01513148|O14|Outcome|Sham NCV Time 10|NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116844|NCT01513148|O13|Outcome|Sham NCV Time 8|NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116845|NCT01513148|O12|Outcome|Sham NCV Time 6|NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116846|NCT01513148|O11|Outcome|Sham NCV Time 4|NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116847|NCT01513148|O10|Outcome|Sham NCV Time 2|NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
116848|NCT01513148|O9|Outcome|Sham NCV Time 0|NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
116849|NCT01513148|O8|Outcome|Sham NCV Pretreatment|NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
116850|NCT01513148|O7|Outcome|Light NCV Time 10|NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
116851|NCT01513148|O6|Outcome|Light NCV Time 8|NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
116852|NCT01513148|O5|Outcome|Light NCV Time 6|NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
116853|NCT01513148|O4|Outcome|Light NCV Time 4|NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
116854|NCT01513148|O3|Outcome|Light NCV Time 2|NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
116855|NCT01513148|O2|Outcome|Light NCV Time 0|NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
116856|NCT01513148|O1|Outcome|Light NCV Pretreatment|NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
116857|NCT01513148|E2|Reported Event|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
116858|NCT01513148|E1|Reported Event|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
116859|NCT01513122|B3|Baseline|Total|Total of all reporting groups
116860|NCT01513122|B2|Baseline|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116861|NCT01513122|B1|Baseline|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116862|NCT01513122|P2|Participant Flow|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116863|NCT01513122|P1|Participant Flow|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116864|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116865|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116866|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116867|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116868|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116869|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116870|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116871|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116872|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116873|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116874|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116875|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116876|NCT01513122|E2|Reported Event|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
116877|NCT01513122|E1|Reported Event|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
116878|NCT01512979|B3|Baseline|Total|Total of all reporting groups
116879|NCT01512979|B2|Baseline|Linagliptin 5mg|Patients treated with linagliptin 5mg
116880|NCT01512979|B1|Baseline|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116881|NCT01512979|P2|Participant Flow|Linagliptin 5mg|Patients treated with linagliptin 5mg
117247|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
116882|NCT01512979|P1|Participant Flow|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116883|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116884|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116885|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116886|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116887|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116888|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116889|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116890|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116891|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116892|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116893|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116894|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116895|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
116896|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116897|NCT01512979|E2|Reported Event|Linagliptin 5mg|Patients treated with linagliptin 5mg
116898|NCT01512979|E1|Reported Event|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
116899|NCT01512849|B3|Baseline|Total|Total of all reporting groups
116900|NCT01512849|B2|Baseline|Entire Population for Normal Renal Function|
116901|NCT01512849|B1|Baseline|Entire Population for Moderate Renal Impairment|
116902|NCT01512849|P4|Participant Flow|Normal Renal Function High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
116903|NCT01512849|P3|Participant Flow|Normal Renal Function Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
116904|NCT01512849|P2|Participant Flow|Moderate Renal Impairment High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
116905|NCT01512849|P1|Participant Flow|Moderate Renal Impairment Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
116906|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
116907|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
116908|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
116909|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
116910|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
116911|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
116912|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
116913|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
116914|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
116915|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
116916|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
116917|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
116918|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
116919|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
116920|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
116921|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
116922|NCT01512849|E4|Reported Event|Normal Renal Function High|TA-7284-High was administered in a single dose.
116923|NCT01512849|E3|Reported Event|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
116924|NCT01512849|E2|Reported Event|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
116925|NCT01512849|E1|Reported Event|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
116926|NCT01512745|B3|Baseline|Total|Total of all reporting groups
116927|NCT01512745|B2|Baseline|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116928|NCT01512745|B1|Baseline|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116929|NCT01512745|P2|Participant Flow|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116930|NCT01512745|P1|Participant Flow|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116931|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116932|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116933|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116934|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116935|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
135203|NCT01433263|O1|Outcome|30mg/kg BYM338|
116936|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116937|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116938|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116939|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116940|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116941|NCT01512745|E2|Reported Event|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116942|NCT01512745|E1|Reported Event|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
116943|NCT01512368|B1|Baseline|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116944|NCT01512368|P1|Participant Flow|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116945|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116946|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116947|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116948|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116949|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116950|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116951|NCT01512368|E1|Reported Event|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
116952|NCT01512160|B5|Baseline|Total|Total of all reporting groups
116953|NCT01512160|B4|Baseline|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116954|NCT01512160|B3|Baseline|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116955|NCT01512160|B2|Baseline|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116956|NCT01512160|B1|Baseline|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116957|NCT01512160|P4|Participant Flow|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116958|NCT01512160|P3|Participant Flow|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116959|NCT01512160|P2|Participant Flow|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116960|NCT01512160|P1|Participant Flow|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
116961|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116962|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116982|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116963|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116964|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116965|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116966|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116967|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116968|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116969|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116970|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116971|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116972|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116973|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116974|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116975|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116976|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116977|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116978|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116979|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116980|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116981|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117248|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
116983|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116984|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116985|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116986|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116987|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116988|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116989|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116990|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116991|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116992|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116993|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116994|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116995|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116996|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116997|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116998|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
116999|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117000|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117001|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
118856|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
117002|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117003|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117004|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117005|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117006|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117007|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117008|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117009|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117010|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117011|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117012|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117013|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117014|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117015|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117016|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117017|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117018|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117019|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117020|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
118857|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
117021|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117022|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117023|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117024|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117025|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117026|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117027|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117028|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117029|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117030|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117031|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117032|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117033|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117034|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117035|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117036|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117037|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117038|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117039|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
118858|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
117040|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117041|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117042|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117043|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117044|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117045|NCT01512160|E4|Reported Event|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117046|NCT01512160|E3|Reported Event|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117047|NCT01512160|E2|Reported Event|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117048|NCT01512160|E1|Reported Event|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
117049|NCT01512108|B3|Baseline|Total|Total of all reporting groups
117050|NCT01512108|B2|Baseline|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117051|NCT01512108|B1|Baseline|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117052|NCT01512108|P2|Participant Flow|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117053|NCT01512108|P1|Participant Flow|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117054|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117055|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117056|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117057|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117058|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117059|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117060|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117150|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
135204|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
117061|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117062|NCT01512108|E2|Reported Event|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
117063|NCT01512108|E1|Reported Event|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
117064|NCT01511939|B4|Baseline|Total|Total of all reporting groups
117065|NCT01511939|B3|Baseline|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117066|NCT01511939|B2|Baseline|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117067|NCT01511939|B1|Baseline|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117068|NCT01511939|P3|Participant Flow|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117069|NCT01511939|P2|Participant Flow|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117070|NCT01511939|P1|Participant Flow|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117071|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117072|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117073|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117074|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117075|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117076|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
118859|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
117077|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117078|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117079|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117080|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117081|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117082|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117083|NCT01511939|E3|Reported Event|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117084|NCT01511939|E2|Reported Event|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117085|NCT01511939|E1|Reported Event|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
117086|NCT01511809|B3|Baseline|Total|Total of all reporting groups
117087|NCT01511809|B2|Baseline|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
117088|NCT01511809|B1|Baseline|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
117089|NCT01511809|P2|Participant Flow|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
117090|NCT01511809|P1|Participant Flow|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
117091|NCT01511809|O2|Outcome|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
117092|NCT01511809|O1|Outcome|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
117093|NCT01511809|E2|Reported Event|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
117094|NCT01511809|E1|Reported Event|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
117095|NCT01511536|B4|Baseline|Total|Total of all reporting groups
117096|NCT01511536|B3|Baseline|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117097|NCT01511536|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117152|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117098|NCT01511536|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117099|NCT01511536|P3|Participant Flow|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117100|NCT01511536|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117101|NCT01511536|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117102|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117103|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117104|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117105|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117106|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117107|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117108|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117109|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117110|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117111|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117112|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117113|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117114|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117115|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117116|NCT01511536|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117117|NCT01511536|E3|Reported Event|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117151|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
135205|NCT01433263|O1|Outcome|30mg/kg BYM338|
117118|NCT01511536|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117119|NCT01511536|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
117120|NCT01511315|B1|Baseline|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117121|NCT01511315|P1|Participant Flow|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117122|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117123|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117124|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117125|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117126|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117127|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117128|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
117129|NCT01511315|E1|Reported Event|Ustekinumab|Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
117130|NCT01511107|B3|Baseline|Total|Total of all reporting groups
117131|NCT01511107|B2|Baseline|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117132|NCT01511107|B1|Baseline|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117133|NCT01511107|P2|Participant Flow|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117134|NCT01511107|P1|Participant Flow|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117135|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117136|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117137|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117138|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117139|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117140|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117141|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117142|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117143|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117144|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117145|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117146|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117147|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117148|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117149|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117153|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117154|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117155|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117156|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117157|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117158|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117159|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117160|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117161|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117162|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117163|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117164|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117165|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117166|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117167|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117168|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117169|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117170|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117171|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117172|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117173|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117174|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117175|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117176|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117177|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117178|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117179|NCT01511107|E2|Reported Event|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
117180|NCT01511107|E1|Reported Event|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
117181|NCT01511016|B3|Baseline|Total|Total of all reporting groups
117182|NCT01511016|B2|Baseline|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117183|NCT01511016|B1|Baseline|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117184|NCT01511016|P2|Participant Flow|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117185|NCT01511016|P1|Participant Flow|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117246|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117186|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117187|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117188|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117189|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117190|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117191|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117192|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117193|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117194|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117195|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117196|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117197|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117198|NCT01511016|E2|Reported Event|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
117199|NCT01511016|E1|Reported Event|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
117200|NCT01510912|B1|Baseline|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
117201|NCT01510912|P1|Participant Flow|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
117202|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
117203|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
135206|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
117204|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
117205|NCT01510912|E1|Reported Event|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
117206|NCT01510834|B1|Baseline|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
117207|NCT01510834|P1|Participant Flow|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
117208|NCT01510834|O1|Outcome|Mean Difference in PHQ-8 (T1, T3)|Mean Difference in PHQ-8 (T1,T3) for study completers
117209|NCT01510834|O1|Outcome|Mean Difference in PSS (T1, T3)|Mean difference in Perceived Stress Scale (T1, T3) for study completers
117210|NCT01510834|O1|Outcome|Mean Difference in QOLS (T1, T3)|Mean Difference in QOLS (T1, T3)for study completers only
117211|NCT01510834|O1|Outcome|Mean Difference in PCL (T1, T3) (Negative Change is Better)|Mean difference in PCL (T1, T3) for study completers
117212|NCT01510834|E1|Reported Event|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
117213|NCT01510769|B4|Baseline|Total|Total of all reporting groups
117214|NCT01510769|B3|Baseline|Placebo + Febuxostat|
117215|NCT01510769|B2|Baseline|Lesinurad 400 mg + Febuxostat|
117216|NCT01510769|B1|Baseline|Lesinurad 200 mg + Febuxostat|
117217|NCT01510769|P3|Participant Flow|Placebo + Febuxostat|
117218|NCT01510769|P2|Participant Flow|Lesinurad 400 mg + Febuxostat|
117219|NCT01510769|P1|Participant Flow|Lesinurad 200 mg + Febuxostat|
117220|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
117221|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
117222|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
117223|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
117224|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
117225|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
117226|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
117227|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
117228|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
117229|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
117230|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
117231|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
117232|NCT01510769|E3|Reported Event|Placebo + Febuxostat|
117233|NCT01510769|E2|Reported Event|Lesinurad 400 mg + Febuxostat|
117234|NCT01510769|E1|Reported Event|Lesinurad 200 mg + Febuxostat|
117235|NCT01510756|B1|Baseline|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117236|NCT01510756|P1|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117237|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117238|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117239|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117240|NCT01510756|E1|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
117241|NCT01510717|B3|Baseline|Total|Total of all reporting groups
117242|NCT01510717|B2|Baseline|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117243|NCT01510717|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117244|NCT01510717|P2|Participant Flow|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117245|NCT01510717|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117249|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117250|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117251|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117252|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117253|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117254|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117255|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117256|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117257|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117258|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117259|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117260|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117261|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117262|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117263|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
117264|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117265|NCT01510717|E3|Reported Event|Monofocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
117266|NCT01510717|E2|Reported Event|Multifocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
117267|NCT01510717|E1|Reported Event|Pre-Treatment|All enrolled participants
117268|NCT01510704|B5|Baseline|Total|Total of all reporting groups
117269|NCT01510704|B4|Baseline|High Dose APD421|20mg dose level
117270|NCT01510704|B3|Baseline|Mid Dose APD421|5mg dose level
117271|NCT01510704|B2|Baseline|Low Dose APD421|1mg dose level
117272|NCT01510704|B1|Baseline|Placebo|
117273|NCT01510704|P4|Participant Flow|High Dose APD421|20mg dose level
117274|NCT01510704|P3|Participant Flow|Mid Dose APD421|5mg dose level
117275|NCT01510704|P2|Participant Flow|Low Dose APD421|1mg dose level
117276|NCT01510704|P1|Participant Flow|Placebo|
117277|NCT01510704|O4|Outcome|High Dose APD421|20mg dose level
117278|NCT01510704|O3|Outcome|Mid Dose APD421|5mg dose level
117279|NCT01510704|O2|Outcome|Low Dose APD421|1mg dose level
117280|NCT01510704|O1|Outcome|Placebo|
117281|NCT01510704|E4|Reported Event|High Dose APD421|20mg dose level
117282|NCT01510704|E3|Reported Event|Mid Dose APD421|5mg dose level
117283|NCT01510704|E2|Reported Event|Low Dose APD421|1mg dose level
117284|NCT01510704|E1|Reported Event|Placebo|
117285|NCT01510652|B3|Baseline|Total|Total of all reporting groups
117286|NCT01510652|B2|Baseline|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117287|NCT01510652|B1|Baseline|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117288|NCT01510652|P2|Participant Flow|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117289|NCT01510652|P1|Participant Flow|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117290|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117291|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117292|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117293|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117294|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117295|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117296|NCT01510652|E2|Reported Event|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
117598|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117297|NCT01510652|E1|Reported Event|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
117298|NCT01510457|B3|Baseline|Total|Total of all reporting groups
117299|NCT01510457|B2|Baseline|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117300|NCT01510457|B1|Baseline|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117301|NCT01510457|P2|Participant Flow|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117302|NCT01510457|P1|Participant Flow|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117303|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117304|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117305|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117306|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117307|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117308|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117309|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117310|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117311|NCT01510457|O2|Outcome|Milnacipran|"Uptitration from 10mg to 50mg BID Milnacipran~Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used."
117312|NCT01510457|O1|Outcome|Sugar Pill|"BID placebo~Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication."
117313|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117314|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117315|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117345|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117316|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117317|NCT01510457|E2|Reported Event|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
117318|NCT01510457|E1|Reported Event|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
117319|NCT01510379|B3|Baseline|Total|Total of all reporting groups
117320|NCT01510379|B2|Baseline|Control|Scheduled ondansetron plus phenergan prn
117321|NCT01510379|B1|Baseline|Reletex|Reletex plus scheduled ondansetron and phenergan prn
117322|NCT01510379|P2|Participant Flow|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117323|NCT01510379|P1|Participant Flow|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117324|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117325|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117326|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117327|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
117328|NCT01510379|E2|Reported Event|Control|Scheduled ondansetron plus phenergan prn
117329|NCT01510379|E1|Reported Event|Reletex|Reletex plus scheduled ondansetron and phenergan prn
117330|NCT01510327|B1|Baseline|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117331|NCT01510327|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117332|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117333|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117334|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117335|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117336|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117337|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117338|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117339|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117340|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117341|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117342|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117343|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117344|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117575|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117346|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117347|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117348|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117349|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117350|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117351|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117352|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117353|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117354|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117355|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117356|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
117357|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
117358|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
117359|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
117360|NCT01510327|E1|Reported Event|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
117361|NCT01510158|B4|Baseline|Total|Total of all reporting groups
117362|NCT01510158|B3|Baseline|Placebo + Allopurinol|placebo qd plus allopurinol
117363|NCT01510158|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117364|NCT01510158|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117365|NCT01510158|P3|Participant Flow|Placebo + Allopurinol|placebo qd plus allopurinol
117366|NCT01510158|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117367|NCT01510158|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117368|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
117369|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117370|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117371|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
117372|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117373|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117374|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
117375|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117376|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117377|NCT01510158|E3|Reported Event|Placebo + Allopurinol|placebo qd plus allopurinol
117378|NCT01510158|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
117379|NCT01510158|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
117380|NCT01510145|B1|Baseline|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
117381|NCT01510145|P1|Participant Flow|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
117382|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
117383|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
117384|NCT01510145|E1|Reported Event|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
117385|NCT01509807|B3|Baseline|Total|Total of all reporting groups
117386|NCT01509807|B2|Baseline|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117387|NCT01509807|B1|Baseline|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117388|NCT01509807|P2|Participant Flow|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117389|NCT01509807|P1|Participant Flow|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117390|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117391|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117392|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117393|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117394|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117395|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117396|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117397|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117398|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117399|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117400|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117401|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117402|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117403|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117599|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117404|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117405|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117406|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117407|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117408|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117409|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117410|NCT01509807|E2|Reported Event|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117411|NCT01509807|E1|Reported Event|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
117412|NCT01509664|B3|Baseline|Total|Total of all reporting groups
117413|NCT01509664|B2|Baseline|Control|Received no discount at the participating supermarket.
117414|NCT01509664|B1|Baseline|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
117415|NCT01509664|P2|Participant Flow|Control|Received no discount at the participating supermarket.
117416|NCT01509664|P1|Participant Flow|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
117417|NCT01509664|O2|Outcome|Control|Received no discount at the participating supermarket.
117418|NCT01509664|O1|Outcome|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
117419|NCT01509664|E2|Reported Event|Control|Received no discount at the participating supermarket.
117420|NCT01509664|E1|Reported Event|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
117421|NCT01509638|B3|Baseline|Total|Total of all reporting groups
117422|NCT01509638|B2|Baseline|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117423|NCT01509638|B1|Baseline|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117424|NCT01509638|P2|Participant Flow|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117425|NCT01509638|P1|Participant Flow|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117426|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117427|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117646|NCT01508702|P2|Participant Flow|Placebo|
117428|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117429|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117430|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117431|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117432|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117433|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117434|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117435|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117436|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117437|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117438|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117439|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117440|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117441|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117442|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117443|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117444|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117445|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117576|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117577|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117647|NCT01508702|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg
117446|NCT01509638|E2|Reported Event|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
117447|NCT01509638|E1|Reported Event|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
117448|NCT01509625|B1|Baseline|One Arm of Metastatic RE Breast Cancer Patients|Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
117449|NCT01509625|P1|Participant Flow|One Arm of Metastatic Breast Cancer Patients|All the patients have tumors with positive estrogen receptors
117450|NCT01509625|O2|Outcome|Patients With Tumors ki67 Negative|Patients with tumors with low ki67 expression
117451|NCT01509625|O1|Outcome|Patients With Tumors ki67 Positive|Patients with tumors with high ki67 expression
117452|NCT01509625|O2|Outcome|Patients With Tumors HER2 Negative|tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive
117453|NCT01509625|O1|Outcome|Patients With Tumors HER2 Positive|tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive
117454|NCT01509625|O2|Outcome|Previous Treatment With Two or More Hormonal Treatment Lines|The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor
117455|NCT01509625|O1|Outcome|Previous Treatment Wiht One Line of Hormonal Treatment|Hormonal treatment was tamoxifen or an aromatase inhibitor
117456|NCT01509625|O2|Outcome|Patients With Visceral Metastasis|Group of patients with metastasis in organs like liver or lungs
117457|NCT01509625|O1|Outcome|Patients Without Visceral Metastasis|Group of patients without metastasis in organs like liver or lungs
117458|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
117459|NCT01509625|O1|Outcome|Patients With Clinical Benefit|Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer
117460|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
117461|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
117462|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
117463|NCT01509625|E1|Reported Event|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
117464|NCT01509586|B3|Baseline|Total|Total of all reporting groups
117465|NCT01509586|B2|Baseline|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
117466|NCT01509586|B1|Baseline|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
117467|NCT01509586|P2|Participant Flow|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
117468|NCT01509586|P1|Participant Flow|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
117469|NCT01509586|O2|Outcome|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
117470|NCT01509586|O1|Outcome|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
117471|NCT01509586|E2|Reported Event|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
117472|NCT01509586|E1|Reported Event|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
117578|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117579|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117473|NCT01509105|B1|Baseline|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117474|NCT01509105|P1|Participant Flow|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117475|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117476|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117477|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117478|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117479|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117480|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117481|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117580|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117581|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117582|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117482|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117483|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117484|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117485|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117486|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117487|NCT01509105|E1|Reported Event|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
117488|NCT01509079|B3|Baseline|Total|Total of all reporting groups
117489|NCT01509079|B2|Baseline|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117490|NCT01509079|B1|Baseline|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117491|NCT01509079|P2|Participant Flow|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117492|NCT01509079|P1|Participant Flow|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117493|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117494|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117495|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117496|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117497|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117498|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117499|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117500|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117501|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117502|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117503|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117504|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117505|NCT01509079|E2|Reported Event|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
117506|NCT01509079|E1|Reported Event|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
117583|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117584|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117648|NCT01508702|O2|Outcome|Placebo|Placebo qd
117507|NCT01509053|B1|Baseline|All Participants|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
117508|NCT01509053|P1|Participant Flow|Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
117509|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117510|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117511|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117512|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117513|NCT01509053|O2|Outcome|Standard of Care|Patients who received oral antipsychotic treatment as standard of care in clinical practice.
117514|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117515|NCT01509053|E3|Reported Event|Aripiprazole IM Depot (Phase C)|Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
117516|NCT01509053|E2|Reported Event|Aripiprazole IM Depot (Phase B)|In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
117517|NCT01509053|E1|Reported Event|Oral Aripiprazole (Phase A)|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
117518|NCT01509040|B4|Baseline|Total|Total of all reporting groups
117519|NCT01509040|B3|Baseline|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117520|NCT01509040|B2|Baseline|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117521|NCT01509040|B1|Baseline|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117522|NCT01509040|P3|Participant Flow|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117523|NCT01509040|P2|Participant Flow|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117524|NCT01509040|P1|Participant Flow|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117525|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117526|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117527|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117585|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117586|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117587|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117528|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117529|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117530|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117531|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117532|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117533|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117534|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117535|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117588|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117589|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117649|NCT01508702|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg
117536|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117537|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117538|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117539|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117540|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117541|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117542|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117543|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117590|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117591|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117592|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117650|NCT01508702|E2|Reported Event|Placebo|
117544|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117545|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117546|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117547|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117548|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117549|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117550|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117551|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117593|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117594|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117595|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117651|NCT01508702|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg
117552|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117553|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117554|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117555|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117556|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
117557|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117558|NCT01509040|O3|Outcome|High Volume Hemofiltration|"Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core"
117559|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core tem"
117596|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117652|NCT01508676|B3|Baseline|Total|Total of all reporting groups
117560|NCT01509040|O1|Outcome|Control|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.~Percutaneous coronary intervention performed as"
117561|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117562|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117563|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117564|NCT01509040|E3|Reported Event|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
117565|NCT01509040|E2|Reported Event|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
117566|NCT01509040|E1|Reported Event|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
117567|NCT01508936|B3|Baseline|Total|Total of all reporting groups
117568|NCT01508936|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117569|NCT01508936|B1|Baseline|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117570|NCT01508936|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117571|NCT01508936|P1|Participant Flow|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117572|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117573|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117574|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117600|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117601|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117602|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117603|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117604|NCT01508936|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
117605|NCT01508936|E1|Reported Event|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
117606|NCT01508910|B4|Baseline|Total|Total of all reporting groups
117607|NCT01508910|B3|Baseline|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
117608|NCT01508910|B2|Baseline|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
117609|NCT01508910|B1|Baseline|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
117610|NCT01508910|P4|Participant Flow|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
117611|NCT01508910|P3|Participant Flow|Unblinded Standard of Care (SOC) Arm|No study-related procedures were performed.
117612|NCT01508910|P2|Participant Flow|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
117613|NCT01508910|P1|Participant Flow|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
117614|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
117615|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
117616|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117617|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117618|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
117619|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
117620|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
117621|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
117622|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117623|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117624|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117625|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117626|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117627|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117628|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117629|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117630|NCT01508910|E4|Reported Event|Not Treated Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
117631|NCT01508910|E3|Reported Event|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
117632|NCT01508910|E2|Reported Event|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
117633|NCT01508910|E1|Reported Event|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
117634|NCT01508832|B3|Baseline|Total|Total of all reporting groups
117635|NCT01508832|B2|Baseline|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
117636|NCT01508832|B1|Baseline|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
117637|NCT01508832|P2|Participant Flow|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
117638|NCT01508832|P1|Participant Flow|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
117639|NCT01508832|O2|Outcome|Bupivacaine|Bupivacaine 0.25% digital nerve block (2cc) in one finger
117640|NCT01508832|O1|Outcome|Lidocaine|Lidocaine 1% digital nerve block (2cc) in one finger
117641|NCT01508832|E2|Reported Event|Bupivacaine|Bupivacaine digital block right or left finger
117642|NCT01508832|E1|Reported Event|Lidocaine|Lidocaine digital block in right or left finger
117643|NCT01508702|B3|Baseline|Total|Total of all reporting groups
117644|NCT01508702|B2|Baseline|Placebo|
117645|NCT01508702|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg
117653|NCT01508676|B2|Baseline|Placebo Phase I|Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
117654|NCT01508676|B1|Baseline|Pennsaid Phase I|Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
117655|NCT01508676|P2|Participant Flow|Placebo Phase I, Pennsaid Phase II|"Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily)."
117656|NCT01508676|P1|Participant Flow|Pennsaid Phase I, Placebo Phase II|"Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily)."
117657|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
117658|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
117659|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
117660|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
117661|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
117662|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
117663|NCT01508676|E2|Reported Event|Placebo|Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
117664|NCT01508676|E1|Reported Event|Pennsaid|Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
117665|NCT01508455|B1|Baseline|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117666|NCT01508455|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117667|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117668|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117669|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117670|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117671|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117672|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117673|NCT01508455|E1|Reported Event|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
117674|NCT01508325|B3|Baseline|Total|Total of all reporting groups
117675|NCT01508325|B2|Baseline|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117676|NCT01508325|B1|Baseline|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117677|NCT01508325|P2|Participant Flow|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117678|NCT01508325|P1|Participant Flow|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
117679|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117680|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117681|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117682|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117683|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117684|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117685|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117686|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117687|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117688|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117689|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117690|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117691|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117692|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117693|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117694|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117695|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117696|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117697|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117698|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117699|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117700|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
135207|NCT01433263|O1|Outcome|30mg/kg BYM338|
117701|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117702|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117703|NCT01508325|E2|Reported Event|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117704|NCT01508325|E1|Reported Event|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
117705|NCT01508169|B3|Baseline|Total|Total of all reporting groups
117706|NCT01508169|B2|Baseline|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117707|NCT01508169|B1|Baseline|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117708|NCT01508169|P2|Participant Flow|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117709|NCT01508169|P1|Participant Flow|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117710|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117711|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117712|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117713|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117714|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117839|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117715|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117716|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117717|NCT01508169|O1|Outcome|Foot Orthosis|Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117718|NCT01508169|E2|Reported Event|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117719|NCT01508169|E1|Reported Event|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
117720|NCT01508130|B3|Baseline|Total|Total of all reporting groups
117721|NCT01508130|B2|Baseline|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117722|NCT01508130|B1|Baseline|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117723|NCT01508130|P2|Participant Flow|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117724|NCT01508130|P1|Participant Flow|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117725|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117726|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117727|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117728|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117729|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117730|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117731|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117732|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
136505|NCT01428765|O1|Outcome|All Patients|
117733|NCT01508130|O1|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117734|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117735|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117736|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117737|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117738|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117739|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117740|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117741|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117742|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117743|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117744|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117745|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117746|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117747|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117748|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117749|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117750|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117751|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117752|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117753|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117840|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117754|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117755|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117756|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117757|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117758|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117759|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117760|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117761|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117762|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117763|NCT01508130|E2|Reported Event|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
117764|NCT01508130|E1|Reported Event|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
117765|NCT01508052|B3|Baseline|Total|Total of all reporting groups
117766|NCT01508052|B2|Baseline|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
117767|NCT01508052|B1|Baseline|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
117768|NCT01508052|P2|Participant Flow|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
117769|NCT01508052|P1|Participant Flow|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
117770|NCT01508052|O2|Outcome|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
117771|NCT01508052|O1|Outcome|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
117772|NCT01508052|E2|Reported Event|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
117773|NCT01508052|E1|Reported Event|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
117774|NCT01508013|B3|Baseline|Total|Total of all reporting groups
117775|NCT01508013|B2|Baseline|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117776|NCT01508013|B1|Baseline|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117777|NCT01508013|P2|Participant Flow|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117778|NCT01508013|P1|Participant Flow|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117779|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117780|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117781|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117782|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117783|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117784|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117785|NCT01508013|E2|Reported Event|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
117786|NCT01508013|E1|Reported Event|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
117787|NCT01507896|B1|Baseline|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
117788|NCT01507896|P1|Participant Flow|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
117789|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117790|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117791|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117792|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117793|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117794|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117795|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117796|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
117841|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117797|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
117798|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
117799|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
117800|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
117801|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117802|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117803|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
117804|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth Minor surgeries.
117805|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117806|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
117807|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117808|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117809|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117810|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117811|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
117812|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117813|NCT01507896|O1|Outcome|All Surgical Procedures|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117842|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117814|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
117815|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117816|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117817|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient com fort. It generally referred to major orthopedic (e.g., joint replacement), major abdom inal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatom ical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117818|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
117819|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117820|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117821|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
117822|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117823|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117824|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
117825|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
117826|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
117827|NCT01507896|E1|Reported Event|All Participants|All unique participants treated with BAX326 per planned surgical procedure.
117828|NCT01507831|B3|Baseline|Total|Total of all reporting groups
117829|NCT01507831|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117830|NCT01507831|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117831|NCT01507831|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117832|NCT01507831|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks.
117833|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117834|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117835|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117836|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117837|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117838|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117843|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117844|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117845|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117846|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117847|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117848|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117849|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117850|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117851|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117852|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117853|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117854|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117855|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117856|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117857|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117858|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117859|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117860|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117861|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117862|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117863|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117864|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117865|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117866|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117867|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117868|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117869|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117870|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117871|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117872|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117873|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117874|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117875|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117876|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117877|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117878|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117879|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117880|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117881|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117882|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117883|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117884|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117885|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117886|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117887|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117888|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117889|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117890|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117891|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117892|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117893|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117894|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117895|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117896|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117897|NCT01507831|E2|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
117898|NCT01507831|E1|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
117899|NCT01507493|B3|Baseline|Total|Total of all reporting groups
117900|NCT01507493|B2|Baseline|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117901|NCT01507493|B1|Baseline|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117902|NCT01507493|P2|Participant Flow|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117903|NCT01507493|P1|Participant Flow|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117904|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117905|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117906|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117907|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117908|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117909|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117910|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117911|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117912|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117913|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117914|NCT01507493|E2|Reported Event|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
117915|NCT01507493|E1|Reported Event|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
117916|NCT01507246|B3|Baseline|Total|Total of all reporting groups
117917|NCT01507246|B2|Baseline|EXPAREL Group|Group receiving EXPAREL
117918|NCT01507246|B1|Baseline|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
117919|NCT01507246|P2|Participant Flow|EXPAREL Group|Group receiving EXPAREL
117920|NCT01507246|P1|Participant Flow|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
117921|NCT01507246|O2|Outcome|EXPAREL Group|Group receiving EXPAREL
117922|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
117923|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
117924|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
117925|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
117926|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
117927|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
117928|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
117929|NCT01507246|E2|Reported Event|EXPAREL Group|Group receiving EXPAREL
117930|NCT01507246|E1|Reported Event|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
117931|NCT01507233|B3|Baseline|Total|Total of all reporting groups
117932|NCT01507233|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117933|NCT01507233|B1|Baseline|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
117934|NCT01507233|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117935|NCT01507233|P1|Participant Flow|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
117936|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117937|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
118046|NCT01507090|O1|Outcome|2D-TAPE|Study coordinators performing measurements
118047|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118048|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
117938|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117939|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
117940|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117941|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
117942|NCT01507233|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117943|NCT01507233|E1|Reported Event|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
117944|NCT01507220|B3|Baseline|Total|Total of all reporting groups
117945|NCT01507220|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117946|NCT01507220|B1|Baseline|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117947|NCT01507220|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117948|NCT01507220|P1|Participant Flow|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117949|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117950|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117951|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117952|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
118049|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118050|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
117953|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117954|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117955|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117956|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117957|NCT01507220|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
117958|NCT01507220|E1|Reported Event|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
117959|NCT01507181|B3|Baseline|Total|Total of all reporting groups
117960|NCT01507181|B2|Baseline|Midazolam|single dose IV midazolam, .45mg/kg
117961|NCT01507181|B1|Baseline|Ketamine|single dose IV ketamine, .5mg/kg
117962|NCT01507181|P2|Participant Flow|Midazolam|"single dose IV midazolam, .45mg/kg~Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes"
117963|NCT01507181|P1|Participant Flow|Ketamine|"single dose IV ketamine, .5mg/kg~Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes"
117964|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117965|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117966|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117967|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117968|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117969|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117970|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117971|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117972|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117973|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117974|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117975|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117976|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117977|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117978|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
117979|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
117980|NCT01507181|E2|Reported Event|Midazolam|single dose IV midazolam, .45mg/kg
117981|NCT01507181|E1|Reported Event|Ketamine|single dose IV ketamine, .5mg/kg
117982|NCT01507155|B1|Baseline|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
117983|NCT01507155|P2|Participant Flow|Patient-Reported Measures|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
117984|NCT01507155|P1|Participant Flow|Clincian-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
117985|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
118051|NCT01507090|E1|Reported Event|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118052|NCT01507051|B5|Baseline|Total|Total of all reporting groups
117986|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
117987|NCT01507155|E2|Reported Event|Patient-Reported Outcomes|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
117988|NCT01507155|E1|Reported Event|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
117989|NCT01507103|B4|Baseline|Total|Total of all reporting groups
117990|NCT01507103|B3|Baseline|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
117991|NCT01507103|B2|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117992|NCT01507103|B1|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117993|NCT01507103|P3|Participant Flow|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
117994|NCT01507103|P2|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117995|NCT01507103|P1|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117996|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
117997|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117998|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
117999|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118000|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118001|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118002|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118003|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118004|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118005|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118006|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118007|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118008|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118009|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118010|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118011|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118012|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118013|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118014|NCT01507103|E3|Reported Event|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
118015|NCT01507103|E2|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118016|NCT01507103|E1|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
118017|NCT01507090|B1|Baseline|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118018|NCT01507090|P1|Participant Flow|Normal Children|Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
118019|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118020|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118021|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118022|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118023|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118024|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118025|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118026|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118027|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118028|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118029|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118030|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118031|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118032|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118033|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118034|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118035|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
118036|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118037|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118038|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118039|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118040|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118041|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118042|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118043|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
118044|NCT01507090|O3|Outcome|Mercy Method|Study coordinators performing measurements
118045|NCT01507090|O2|Outcome|3D-TAPE|Study coordinators performing measurements
118053|NCT01507051|B4|Baseline|Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
118054|NCT01507051|B3|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118055|NCT01507051|B2|Baseline|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118056|NCT01507051|B1|Baseline|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118057|NCT01507051|P4|Participant Flow|Group D: Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
118058|NCT01507051|P3|Participant Flow|Group C: Rivaroxaban Without Any Pre-treatment With Warfarin|Days 0 to 3: 20 mg rivaroxaban once daily
118059|NCT01507051|P2|Participant Flow|Group B: Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118060|NCT01507051|P1|Participant Flow|Group A: Warfarin Followed by Rivaroxaban|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118061|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118062|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118063|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118064|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118065|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118066|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118067|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118068|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118069|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118070|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118071|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118072|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118073|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118074|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118075|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118076|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118077|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118078|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118079|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118080|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118081|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118082|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118083|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118084|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118085|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118086|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118087|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118088|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118089|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118090|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118091|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118092|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118093|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118094|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118095|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118096|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118097|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118098|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118099|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118100|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118101|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118102|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118103|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118104|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118105|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118106|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118107|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118198|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118403|NCT01504971|O3|Outcome|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
118108|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118109|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118110|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118111|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118112|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118113|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118114|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118115|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118116|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118117|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118118|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118119|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118120|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118121|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118122|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118123|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118124|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118125|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118126|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118127|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118128|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118129|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118130|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118131|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118132|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118133|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118134|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118135|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118136|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118137|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118138|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118139|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118140|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118141|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118142|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118143|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118144|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118145|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118146|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118147|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118148|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118149|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118150|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118151|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118152|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118153|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118154|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118155|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118156|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118157|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118158|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118159|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118160|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118161|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118162|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118199|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118200|NCT01506908|E2|Reported Event|Placebo Lozenge|Participants received a single dose of matched placebo mint lozenge, through oral route.
118163|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118164|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118165|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118166|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118167|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118168|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118169|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118170|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
118171|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
118172|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
118173|NCT01507051|E4|Reported Event|RG4: Warfarin Alone|All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section.
118174|NCT01507051|E3|Reported Event|RG3: Rivaroxaban|All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section.
118175|NCT01507051|E2|Reported Event|RG2: Warfarin Followed by Placebo|All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section.
118176|NCT01507051|E1|Reported Event|RG1: Warfarin Followed by Rivaroxaban|All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section.
118177|NCT01506960|B1|Baseline|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
118178|NCT01506960|P1|Participant Flow|Coronary Stenting With OCT, NIRS/IVUS|All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
118179|NCT01506960|O2|Outcome|Deep Lipid|
118180|NCT01506960|O1|Outcome|Superficial Lipid|
118181|NCT01506960|O1|Outcome|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
118182|NCT01506960|E1|Reported Event|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
118183|NCT01506908|B3|Baseline|Total|Total of all reporting groups
118184|NCT01506908|B2|Baseline|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118185|NCT01506908|B1|Baseline|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118186|NCT01506908|P2|Participant Flow|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118187|NCT01506908|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg)|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118188|NCT01506908|O2|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118189|NCT01506908|O1|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118190|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118191|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118192|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118193|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118194|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118195|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118196|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
118197|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118860|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
118201|NCT01506908|E1|Reported Event|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
118202|NCT01506882|B3|Baseline|Total Title|
118203|NCT01506882|B2|Baseline|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118204|NCT01506882|B1|Baseline|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118205|NCT01506882|P2|Participant Flow|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118206|NCT01506882|P1|Participant Flow|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118207|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118208|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118209|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118210|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118211|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118212|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118213|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118214|NCT01506882|O1|Outcome|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118215|NCT01506882|E2|Reported Event|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
118216|NCT01506882|E1|Reported Event|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
118217|NCT01506726|B3|Baseline|Total|Total of all reporting groups
118218|NCT01506726|B2|Baseline|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118219|NCT01506726|B1|Baseline|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118220|NCT01506726|P2|Participant Flow|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118404|NCT01504971|O2|Outcome|Participants Same to arm1|Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease
118405|NCT01504971|O1|Outcome|Participants|Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease
118221|NCT01506726|P1|Participant Flow|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118222|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118223|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118224|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118225|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118226|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118227|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118228|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118229|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118230|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118231|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118232|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118233|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118234|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118406|NCT01504971|E3|Reported Event|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
118407|NCT01504971|E2|Reported Event|Participants Same to arm1|Diagnostic capabilities of AFI in the diagnosis of GERD
118235|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118236|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118237|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118238|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118239|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118240|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118241|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118242|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118243|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118244|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118245|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118246|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118247|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118248|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118408|NCT01504971|E1|Reported Event|Participants|Diagnostic capabilities of WLI in the diagnosis of GERD
118409|NCT01504867|B3|Baseline|Total|Total of all reporting groups
118410|NCT01504867|B2|Baseline|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118249|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118250|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118251|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118252|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118253|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118254|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118255|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118256|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118257|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118258|NCT01506726|E2|Reported Event|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
118259|NCT01506726|E1|Reported Event|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
118260|NCT01506596|B1|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118261|NCT01506596|P1|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118262|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118263|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118264|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118265|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118266|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118267|NCT01506596|E1|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
118268|NCT01506362|B1|Baseline|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
118269|NCT01506362|P1|Participant Flow|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
118270|NCT01506362|O1|Outcome|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
118271|NCT01506362|E1|Reported Event|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
118272|NCT01506323|B3|Baseline|Total|Total of all reporting groups
118273|NCT01506323|B2|Baseline|Present Centered Therapy (PCT)|Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
118274|NCT01506323|B1|Baseline|Mantram Repetition Program (MRP)|The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118275|NCT01506323|P2|Participant Flow|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
118276|NCT01506323|P1|Participant Flow|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118313|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118411|NCT01504867|B1|Baseline|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118277|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118278|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118279|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118280|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118281|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118282|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118283|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118284|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118285|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118286|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118314|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118412|NCT01504867|P2|Participant Flow|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118287|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118288|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118289|NCT01506323|O2|Outcome|Present Centered Therapy|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118290|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118291|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)`|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118292|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118293|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118294|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118295|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118296|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118315|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118413|NCT01504867|P1|Participant Flow|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118297|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118298|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118299|NCT01506323|E2|Reported Event|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
118300|NCT01506323|E1|Reported Event|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
118301|NCT01506193|B4|Baseline|Total|Total of all reporting groups
118302|NCT01506193|B3|Baseline|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118303|NCT01506193|B2|Baseline|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118304|NCT01506193|B1|Baseline|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118305|NCT01506193|P3|Participant Flow|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118306|NCT01506193|P2|Participant Flow|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118307|NCT01506193|P1|Participant Flow|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118308|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118309|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118310|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118311|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118312|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118414|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118316|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118317|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118318|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118319|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118320|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118321|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118322|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118323|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118324|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118325|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118326|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118327|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118328|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118329|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118330|NCT01506193|O2|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118331|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118332|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118333|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118415|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118334|NCT01506193|E3|Reported Event|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118335|NCT01506193|E2|Reported Event|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118336|NCT01506193|E1|Reported Event|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
118337|NCT01505881|B3|Baseline|Total|Total of all reporting groups
118338|NCT01505881|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118339|NCT01505881|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
118340|NCT01505881|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118341|NCT01505881|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
118342|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118343|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
118344|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118345|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
118346|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
118347|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
118348|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118349|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
118350|NCT01505881|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
118351|NCT01505881|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
118352|NCT01505647|B3|Baseline|Total|Total of all reporting groups
118353|NCT01505647|B2|Baseline|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118354|NCT01505647|B1|Baseline|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118355|NCT01505647|P2|Participant Flow|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118356|NCT01505647|P1|Participant Flow|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118357|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118358|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118359|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118360|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118361|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118362|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118363|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118364|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118365|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118366|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118367|NCT01505647|E2|Reported Event|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
118368|NCT01505647|E1|Reported Event|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
118369|NCT01505608|B3|Baseline|Total|Total of all reporting groups
118400|NCT01504997|E1|Reported Event|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
118401|NCT01504971|B1|Baseline|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
118370|NCT01505608|B2|Baseline|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118371|NCT01505608|B1|Baseline|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118372|NCT01505608|P2|Participant Flow|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118373|NCT01505608|P1|Participant Flow|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118374|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118375|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118376|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118377|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118378|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118379|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118402|NCT01504971|P1|Participant Flow|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
118380|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118381|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118382|NCT01505608|O2|Outcome|Phase I Patients + Phase II Assigned Arm B- Tmz +I+ TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118383|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118384|NCT01505608|O2|Outcome|Arm A- TMZ + Irinotecan Only|Did not receive TPI 287
118385|NCT01505608|O1|Outcome|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118386|NCT01505608|E2|Reported Event|Phase II Arm A- Subjects That Did Not Receive TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118387|NCT01505608|E1|Reported Event|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
118388|NCT01505387|B3|Baseline|Total|Total of all reporting groups
118389|NCT01505387|B2|Baseline|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
118390|NCT01505387|B1|Baseline|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
118391|NCT01505387|P2|Participant Flow|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
118392|NCT01505387|P1|Participant Flow|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
118393|NCT01505387|O2|Outcome|Litramine|"Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
118394|NCT01505387|O1|Outcome|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
118395|NCT01505387|E2|Reported Event|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
118396|NCT01505387|E1|Reported Event|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
118397|NCT01504997|B1|Baseline|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
118398|NCT01504997|P1|Participant Flow|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
118399|NCT01504997|O1|Outcome|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
118861|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
118416|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118417|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118418|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118419|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118420|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118421|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118422|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118423|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118424|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118425|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118426|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118427|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118428|NCT01504867|E2|Reported Event|Placebo|This group received matching lactose powder filled capsules on days 1-7.
118429|NCT01504867|E1|Reported Event|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
118430|NCT01504854|B3|Baseline|Total|Total of all reporting groups
118431|NCT01504854|B2|Baseline|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118432|NCT01504854|B1|Baseline|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118433|NCT01504854|P2|Participant Flow|Placebo|"Subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118434|NCT01504854|P1|Participant Flow|Resveratrol|"Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118435|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118436|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118437|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118438|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118439|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118440|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118441|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118442|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118443|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118444|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118445|NCT01504854|E2|Reported Event|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
118446|NCT01504854|E1|Reported Event|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
118447|NCT01503749|B4|Baseline|Total|Total of all reporting groups
118542|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118448|NCT01503749|B3|Baseline|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
118449|NCT01503749|B2|Baseline|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
118450|NCT01503749|B1|Baseline|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
118451|NCT01503749|P3|Participant Flow|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
118452|NCT01503749|P2|Participant Flow|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
118453|NCT01503749|P1|Participant Flow|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
118454|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
118455|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
118456|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
118457|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
118458|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
118459|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
118460|NCT01503749|E3|Reported Event|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
118461|NCT01503749|E2|Reported Event|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
118462|NCT01503749|E1|Reported Event|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
118463|NCT01503021|B3|Baseline|Total|Total of all reporting groups
118464|NCT01503021|B2|Baseline|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
118465|NCT01503021|B1|Baseline|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
118466|NCT01503021|P2|Participant Flow|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
118467|NCT01503021|P1|Participant Flow|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
118468|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118469|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118470|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118471|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118472|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118473|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118474|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118475|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118476|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118477|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118478|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118479|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118480|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118481|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118482|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118483|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118484|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
136506|NCT01428765|O1|Outcome|All Patients|
118485|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
118486|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118487|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118488|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118489|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118490|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118491|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118492|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118493|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118494|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118495|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118496|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118497|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118498|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118499|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118500|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118501|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118502|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118503|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118504|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118505|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118506|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118507|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118508|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118509|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118510|NCT01503021|E3|Reported Event|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118511|NCT01503021|E2|Reported Event|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
118512|NCT01503021|E1|Reported Event|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
118513|NCT01502787|B1|Baseline|All Participants|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
118543|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118544|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118545|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118546|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118514|NCT01502787|P2|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
118515|NCT01502787|P1|Participant Flow|Metoprolol First Then Nebivolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
118516|NCT01502787|O2|Outcome|Second Intervention Nebivolol: 24 Weeks|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
118517|NCT01502787|O1|Outcome|First Intervention Metoprolol: 12 Weeks|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
118518|NCT01502787|E2|Reported Event|Nebivolol 21 Subjects|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
118519|NCT01502787|E1|Reported Event|Metoprolol 21 Subjects|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
118520|NCT01502709|B3|Baseline|Total|Total of all reporting groups
118521|NCT01502709|B2|Baseline|Placebo Arm|0 participants received placebo
118522|NCT01502709|B1|Baseline|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118523|NCT01502709|P2|Participant Flow|Placebo Arm|0 participants received placebo
118524|NCT01502709|P1|Participant Flow|Caloric Vestibular Neurostimulation|1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118525|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
118526|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118527|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
118528|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118529|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
118530|NCT01502709|O1|Outcome|Neurostimulator|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118531|NCT01502709|E2|Reported Event|Placebo Arm|0 participants received placebo
118532|NCT01502709|E1|Reported Event|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
118533|NCT01502423|B3|Baseline|Total|Total of all reporting groups
118534|NCT01502423|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
118535|NCT01502423|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
118536|NCT01502423|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
118537|NCT01502423|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
118538|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118539|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118540|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118541|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
136507|NCT01428765|O1|Outcome|All Patients|
118547|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118548|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118549|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118550|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118551|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118552|NCT01502423|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
118553|NCT01502423|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
118554|NCT01502410|B5|Baseline|Total|Total of all reporting groups
118555|NCT01502410|B4|Baseline|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118556|NCT01502410|B3|Baseline|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118557|NCT01502410|B2|Baseline|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118558|NCT01502410|B1|Baseline|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118559|NCT01502410|P4|Participant Flow|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118560|NCT01502410|P3|Participant Flow|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118561|NCT01502410|P2|Participant Flow|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118562|NCT01502410|P1|Participant Flow|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118563|NCT01502410|O4|Outcome|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118564|NCT01502410|O3|Outcome|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118565|NCT01502410|O2|Outcome|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118566|NCT01502410|O1|Outcome|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
118636|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
136508|NCT01428765|O1|Outcome|All Patients|
118567|NCT01502410|E2|Reported Event|Group 2 Relapsed/Refractory Wilms Tumor|Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
118568|NCT01502410|E1|Reported Event|Group 1 Relapsed/Refractory Rhabdomyosarcoma|Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
118569|NCT01502371|B6|Baseline|Total|Total of all reporting groups
118570|NCT01502371|B5|Baseline|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118571|NCT01502371|B4|Baseline|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118572|NCT01502371|B3|Baseline|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118573|NCT01502371|B2|Baseline|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118574|NCT01502371|B1|Baseline|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118575|NCT01502371|P5|Participant Flow|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118576|NCT01502371|P4|Participant Flow|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118577|NCT01502371|P3|Participant Flow|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118578|NCT01502371|P2|Participant Flow|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118579|NCT01502371|P1|Participant Flow|MF MDI 50 mcg BID|Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
118580|NCT01502371|O2|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118581|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118582|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118583|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118584|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118585|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118586|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118587|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118588|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118589|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118590|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118591|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118592|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118593|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118594|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118595|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118596|NCT01502371|E5|Reported Event|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118597|NCT01502371|E4|Reported Event|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
118598|NCT01502371|E3|Reported Event|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118599|NCT01502371|E2|Reported Event|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118600|NCT01502371|E1|Reported Event|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
118601|NCT01502332|B3|Baseline|Total|Total of all reporting groups
118602|NCT01502332|B2|Baseline|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118603|NCT01502332|B1|Baseline|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118637|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118604|NCT01502332|P2|Participant Flow|Moderate Alveolar Recruitment|Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118605|NCT01502332|P1|Participant Flow|Intensive Alveolar Recruitment|Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118606|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118607|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118608|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118609|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118610|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118611|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118612|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118613|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118614|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118615|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118616|NCT01502332|E2|Reported Event|Moderate Alveolar Recruitment ARM|Mechanical ventilation strategy: Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118617|NCT01502332|E1|Reported Event|Intensive Alveolar Recruitment ARM|Mechanical ventilation strategy: Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
118618|NCT01502033|B1|Baseline|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
118619|NCT01502033|P1|Participant Flow|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
118620|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"
118621|NCT01502033|O1|Outcome|Open Label Active Treatment|All participants had unblended treatment
118622|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
118623|NCT01502033|E1|Reported Event|Open Label Active Treatment|All participants had unblinded treatment
118624|NCT01500434|B1|Baseline|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118625|NCT01500434|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118626|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118627|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118628|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118629|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118630|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118631|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118632|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118633|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118634|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118635|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118638|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118639|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118640|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118641|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118642|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118643|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118644|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118645|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118646|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118647|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118648|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118649|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118650|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118651|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118652|NCT01500434|E1|Reported Event|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
118653|NCT01500382|B5|Baseline|Total|Total of all reporting groups
118654|NCT01500382|B4|Baseline|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
118655|NCT01500382|B3|Baseline|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
118656|NCT01500382|B2|Baseline|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
118657|NCT01500382|B1|Baseline|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
118658|NCT01500382|P4|Participant Flow|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
118659|NCT01500382|P3|Participant Flow|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
118660|NCT01500382|P2|Participant Flow|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
118661|NCT01500382|P1|Participant Flow|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
118662|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118663|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
118664|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
118665|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118666|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118667|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
118668|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
118669|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118670|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118671|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
118672|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
118834|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
118673|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118674|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118675|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
118676|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
118677|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118678|NCT01500382|E4|Reported Event|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118679|NCT01500382|E3|Reported Event|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
118680|NCT01500382|E2|Reported Event|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
118681|NCT01500382|E1|Reported Event|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
118682|NCT01501162|B3|Baseline|Total|Total of all reporting groups
118683|NCT01501162|B2|Baseline|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
118684|NCT01501162|B1|Baseline|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
118685|NCT01501162|P2|Participant Flow|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
118686|NCT01501162|P1|Participant Flow|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
118687|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
118688|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
118689|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
118690|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
118691|NCT01501162|E2|Reported Event|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
118692|NCT01501162|E1|Reported Event|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
118693|NCT01501110|B3|Baseline|Total|Total of all reporting groups
118694|NCT01501110|B2|Baseline|no Intervention|No intervention / usual care
118695|NCT01501110|B1|Baseline|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
118696|NCT01501110|P2|Participant Flow|no Intervention|No intervention / usual care
118697|NCT01501110|P1|Participant Flow|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
118698|NCT01501110|O2|Outcome|no Intervention|No intervention / usual care
118699|NCT01501110|O1|Outcome|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
118700|NCT01501110|E2|Reported Event|no Intervention|No intervention / usual care
118701|NCT01501110|E1|Reported Event|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
118702|NCT01500772|B1|Baseline|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118703|NCT01500772|P1|Participant Flow|Alisporivir|Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
118704|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118705|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118706|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118707|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118708|NCT01500772|E1|Reported Event|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
118709|NCT01500746|B3|Baseline|Total|Total of all reporting groups
118710|NCT01500746|B2|Baseline|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
118711|NCT01500746|B1|Baseline|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
118712|NCT01500746|P2|Participant Flow|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
118713|NCT01500746|P1|Participant Flow|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
118714|NCT01500746|O2|Outcome|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
118715|NCT01500746|O1|Outcome|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
118716|NCT01500746|E2|Reported Event|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
118717|NCT01500746|E1|Reported Event|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
118718|NCT01500720|B3|Baseline|Total|Total of all reporting groups
118719|NCT01500720|B2|Baseline|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118720|NCT01500720|B1|Baseline|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118721|NCT01500720|P2|Participant Flow|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118722|NCT01500720|P1|Participant Flow|Cabazitaxel|Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118723|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118724|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118725|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118726|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118727|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118728|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118729|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118730|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118731|NCT01500720|E2|Reported Event|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118732|NCT01500720|E1|Reported Event|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
118733|NCT01500629|B3|Baseline|Total|Total of all reporting groups
118734|NCT01500629|B2|Baseline|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118735|NCT01500629|B1|Baseline|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118736|NCT01500629|P2|Participant Flow|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118737|NCT01500629|P1|Participant Flow|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118738|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118835|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
118836|NCT01500317|O3|Outcome|Placebo|Placebo tid
118837|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
118838|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
118839|NCT01500317|O3|Outcome|Placebo|Placebo tid
118739|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118740|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118741|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118742|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118743|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118744|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118745|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118746|NCT01500629|O2|Outcome|C-1266-6 Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118747|NCT01500629|O1|Outcome|C-1266-7 Then C-1266-6|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118748|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118749|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118750|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118840|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
118751|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118752|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118753|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118754|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118755|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118756|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118757|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118758|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118759|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118760|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118761|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118762|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118841|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
118763|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118764|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118765|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118766|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118767|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118768|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118769|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118770|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118771|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118772|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118773|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118774|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118842|NCT01500317|E3|Reported Event|Placebo|Placebo tid
118775|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118776|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118777|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118778|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118779|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118780|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118781|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118782|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118783|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118784|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118785|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118786|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118843|NCT01500317|E2|Reported Event|Oxycodone|5 mg oxycodone tid
118787|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118788|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118789|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118790|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118791|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118792|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118793|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118794|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118795|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118796|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118797|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118798|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118844|NCT01500317|E1|Reported Event|Tapentadol|75 mg tapentadol tid
118799|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118800|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118801|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118802|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118803|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118804|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118805|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118806|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118807|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118808|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118809|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118845|NCT01500252|B3|Baseline|Total|Total of all reporting groups
118846|NCT01500252|B2|Baseline|Patellar Retention|Subjects retained their native patella.
118847|NCT01500252|B1|Baseline|Patellar Resurfacing|Subjects received patellar resurfacing.
118848|NCT01500252|P2|Participant Flow|Patellar Retention|Subjects retained their native patella.
118849|NCT01500252|P1|Participant Flow|Patellar Resurfacing|Subjects received patellar resurfacing.
118810|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118811|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118812|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo).. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo).: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118813|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118814|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6, (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118815|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118816|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118817|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
118818|NCT01500629|E2|Reported Event|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118819|NCT01500629|E1|Reported Event|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
118820|NCT01500317|B4|Baseline|Total|Total of all reporting groups
118821|NCT01500317|B3|Baseline|Placebo|Placebo tid
118822|NCT01500317|B2|Baseline|Oxycodone|5 mg oxycodone tid
118823|NCT01500317|B1|Baseline|Tapentadol|75 mg tapentadol tid
118824|NCT01500317|P3|Participant Flow|Placebo|Placebo tid
118825|NCT01500317|P2|Participant Flow|Oxycodone|5 mg oxycodone tid
118826|NCT01500317|P1|Participant Flow|Tapentadol|75 mg tapentadol tid
118827|NCT01500317|O3|Outcome|Placebo|Placebo tid
118828|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
118829|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
118830|NCT01500317|O3|Outcome|Placebo|Placebo tid
118831|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
118832|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
118833|NCT01500317|O3|Outcome|Placebo|Placebo tid
118862|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
118863|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
118864|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
118865|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
118866|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
118867|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
118868|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
118869|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
118870|NCT01500252|E2|Reported Event|Patellar Retention|Subjects retained their native patella.
118871|NCT01500252|E1|Reported Event|Patellar Resurfacing|Subjects received patellar resurfacing.
118872|NCT01500226|B3|Baseline|Total|Total of all reporting groups
118873|NCT01500226|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118874|NCT01500226|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118875|NCT01500226|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118876|NCT01500226|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy."
118877|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118878|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118879|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118880|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118881|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118882|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
118883|NCT01500226|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~685 subjects were randomized to control~674 of those who were randomized to control received control in C1~Safety = 674 control"
118884|NCT01500226|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~684 subjects were randomized to Rolapitant~670 of those randomized to Rolapitant received rolapitant in C1~Safety = 670 Rolapitant"
118885|NCT01500213|B3|Baseline|Total|Total of all reporting groups
118886|NCT01500213|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118887|NCT01500213|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118888|NCT01500213|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118935|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118936|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118889|NCT01500213|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118890|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118891|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118892|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118893|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118894|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118895|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118896|NCT01500213|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~277 subjects were randomized to control;~274 of those who were randomized to control received control in C1.~Safety = 274 control"
118897|NCT01500213|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~278 subjects were randomized to Rolapitant~272 of those randomized to Rolapitant received Rolapitant in C1~Safety = 272 Rolapitant"
118898|NCT01500135|B3|Baseline|Total|Total of all reporting groups
118899|NCT01500135|B2|Baseline|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118900|NCT01500135|B1|Baseline|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118901|NCT01500135|P2|Participant Flow|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118902|NCT01500135|P1|Participant Flow|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118903|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118904|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118905|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118906|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118907|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118908|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
119186|NCT01499290|E1|Reported Event|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment.
118909|NCT01500135|E2|Reported Event|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118910|NCT01500135|E1|Reported Event|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
118911|NCT01500109|B4|Baseline|Total|Total of all reporting groups
118912|NCT01500109|B3|Baseline|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
118913|NCT01500109|B2|Baseline|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
118914|NCT01500109|B1|Baseline|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
118915|NCT01500109|P3|Participant Flow|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
118916|NCT01500109|P2|Participant Flow|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
118917|NCT01500109|P1|Participant Flow|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
118918|NCT01500109|O3|Outcome|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
118937|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118938|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118939|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118919|NCT01500109|O2|Outcome|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
118920|NCT01500109|O1|Outcome|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
118921|NCT01500109|E3|Reported Event|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
118922|NCT01500109|E2|Reported Event|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
118923|NCT01500109|E1|Reported Event|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
118924|NCT01500083|B3|Baseline|Total|Total of all reporting groups
118925|NCT01500083|B2|Baseline|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
118926|NCT01500083|B1|Baseline|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
118927|NCT01500083|P2|Participant Flow|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
118928|NCT01500083|P1|Participant Flow|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
118929|NCT01500083|O2|Outcome|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
118930|NCT01500083|O1|Outcome|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
118931|NCT01500083|E2|Reported Event|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
118932|NCT01500083|E1|Reported Event|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
118933|NCT01500031|B1|Baseline|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
118934|NCT01500031|P1|Participant Flow|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
119187|NCT01499277|B3|Baseline|Total|Total of all reporting groups
118940|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118941|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118942|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118943|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118944|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118945|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118946|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118947|NCT01500031|E1|Reported Event|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
118948|NCT01499862|B1|Baseline|All Participants|All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
118949|NCT01499862|P1|Participant Flow|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
118950|NCT01499862|O3|Outcome|Patient 3|Ambulation speed (meters/second)
118951|NCT01499862|O2|Outcome|Patient 2|Ambulation speed (meters/second)
118952|NCT01499862|O1|Outcome|Patient 1|Ambulation speed (meters/second)
118953|NCT01499862|O3|Outcome|Patient 3|Step Length (meters)
118954|NCT01499862|O2|Outcome|Patient 2|Step Length (meters)
118955|NCT01499862|O1|Outcome|Patient 1|Step Length (meters)
118956|NCT01499862|O3|Outcome|Patient 3|Five Times Sit to Stand Test (seconds)
118957|NCT01499862|O2|Outcome|Patient 2|Five Times Sit to Stand Test (seconds)
118958|NCT01499862|O1|Outcome|Patient 1|Five Times Sit to Stand Test (seconds)
118959|NCT01499862|O3|Outcome|Patient 3|Timed Up and Go Test (seconds)
118960|NCT01499862|O2|Outcome|Patient 2|Timed Up and Go Test (seconds)
118961|NCT01499862|O1|Outcome|Patient 1|Timed Up and Go Test (seconds)
118962|NCT01499862|O3|Outcome|Patient 3|Six Minute Walk Test (meters)
118963|NCT01499862|O2|Outcome|Patient 2|Six Minute Walk Test (meters)
118964|NCT01499862|O1|Outcome|Patient 1|Six Minute Walk Test (meters)
118965|NCT01499862|E1|Reported Event|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
118966|NCT01499849|B3|Baseline|Total|Total of all reporting groups
118967|NCT01499849|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118968|NCT01499849|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118969|NCT01499849|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118970|NCT01499849|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118971|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118972|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118973|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118974|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118975|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118976|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118977|NCT01499849|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
119034|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119188|NCT01499277|B2|Baseline|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
118978|NCT01499849|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
118979|NCT01499810|B1|Baseline|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118980|NCT01499810|P1|Participant Flow|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118981|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118982|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118983|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118984|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118985|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118986|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119035|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
118987|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118988|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118989|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118990|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118991|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118992|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118993|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118994|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119036|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119037|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119038|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
118995|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118996|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118997|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118998|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
118999|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119000|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119001|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119002|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119039|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119040|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119041|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119003|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119004|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119005|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119006|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119007|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119008|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119009|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119010|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119042|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119043|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119044|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119011|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119012|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119013|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119014|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119015|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119016|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119017|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119018|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119045|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119046|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119047|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119019|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119020|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119021|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119022|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119023|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119024|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119025|NCT01499810|E1|Reported Event|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
119026|NCT01499667|B4|Baseline|Total|Total of all reporting groups
119027|NCT01499667|B3|Baseline|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod
119028|NCT01499667|B2|Baseline|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119029|NCT01499667|B1|Baseline|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119030|NCT01499667|P3|Participant Flow|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119031|NCT01499667|P2|Participant Flow|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119032|NCT01499667|P1|Participant Flow|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119033|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119048|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119049|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119050|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119051|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119052|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119053|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119054|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119055|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119056|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119057|NCT01499667|E3|Reported Event|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
119058|NCT01499667|E2|Reported Event|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
119059|NCT01499667|E1|Reported Event|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
119060|NCT01499654|B1|Baseline|Study Group|Entire cohort
119061|NCT01499654|P1|Participant Flow|Study Group|Entire cohort
119062|NCT01499654|O3|Outcome|Injection 1 to Injection 2|Time in minutes between the first 1/2 dose injection and the second 1/2 dose injection
119063|NCT01499654|O2|Outcome|Injection 2 to Scan 2|Time in minutes between the second 1/2 dose injection and the second scan.
119064|NCT01499654|O1|Outcome|Injection 1 to Scan 1|Time in minutes between the first 1/2 dose injection and the first scan
119065|NCT01499654|O1|Outcome|Study Group|Entire cohort
119066|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119067|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119068|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
119069|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119070|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119071|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
119072|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119073|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119074|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
119075|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119076|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
119077|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
119078|NCT01499654|E1|Reported Event|Study Group|Entire cohort for the study
119079|NCT01499576|B1|Baseline|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
119080|NCT01499576|P1|Participant Flow|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
119081|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
119082|NCT01499576|O1|Outcome|Acetic Acid Spraying|The same participants primary outcome analysed
119083|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
119084|NCT01499576|E1|Reported Event|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
119085|NCT01499498|B1|Baseline|Sildenafil and Boceprevir|All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
119086|NCT01499498|P1|Participant Flow|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
119087|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
119088|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
119089|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir: 25mg once/800mg three times a day"
119090|NCT01499498|O1|Outcome|Bocepreprivir Alone|"Healthy volunteers~Boceprevir: 800mg three times a day"
119091|NCT01499498|O1|Outcome|Sildenafil Only|"Healthy volunteers~Sildenafil 25mg once"
119092|NCT01499498|E1|Reported Event|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
119121|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119189|NCT01499277|B1|Baseline|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119093|NCT01499355|B1|Baseline|All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
119094|NCT01499355|P4|Participant Flow|Double-Blind Period: BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
119095|NCT01499355|P3|Participant Flow|Double-Blind Period: BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
119096|NCT01499355|P2|Participant Flow|Double-Blind Period: Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
119097|NCT01499355|P1|Participant Flow|Run-In Period: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
119098|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119099|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119100|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119101|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119102|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119103|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119104|NCT01499355|O1|Outcome|Run-In: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
119105|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119106|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119107|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119108|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119109|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119110|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119111|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119112|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119113|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119114|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119115|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119116|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119117|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119118|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119119|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119120|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119122|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119123|NCT01499355|E4|Reported Event|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119124|NCT01499355|E3|Reported Event|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119125|NCT01499355|E2|Reported Event|Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
119126|NCT01499355|E1|Reported Event|Run-in Period|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
119127|NCT01499303|B3|Baseline|Total|Total of all reporting groups
119128|NCT01499303|B2|Baseline|200mg BID|200mg Fostmatinib BID
119129|NCT01499303|B1|Baseline|100mg BID|100mg Fostmatinib BID
119130|NCT01499303|P2|Participant Flow|200mg BID|200mg Fostmatinib BID
119131|NCT01499303|P1|Participant Flow|100mg BID|100mg Fostmatinib BID
119132|NCT01499303|O2|Outcome|200mg BID|200mg Fostmatinib BID
119133|NCT01499303|O1|Outcome|100mg BID|100mg Fostmatinib BID
119134|NCT01499303|E2|Reported Event|200mg BID|200mg Fostmatinib BID
119135|NCT01499303|E1|Reported Event|100mg BID|100mg Fostmatinib BID
119136|NCT01499290|B3|Baseline|Total|Total of all reporting groups
119137|NCT01499290|B2|Baseline|Meropenem|1000 mg: IV treatment
119138|NCT01499290|B1|Baseline|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119139|NCT01499290|P2|Participant Flow|Meropenem|1000 mg: IV treatment
119140|NCT01499290|P1|Participant Flow|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119141|NCT01499290|O6|Outcome|AVI (3)|300-360 mins after dose
119142|NCT01499290|O5|Outcome|CAZ (3)|300-360 mins after dose
119143|NCT01499290|O4|Outcome|AVI (2)|30-90 mins after dose
119144|NCT01499290|O3|Outcome|CAZ (2)|30-90 mins after dose
119145|NCT01499290|O2|Outcome|AVI (1)|30 min before/after dose
119146|NCT01499290|O1|Outcome|CAZ (1)|30 mins before/after dose
119147|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119148|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119149|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119150|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119151|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
119152|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
119153|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119154|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119155|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
119156|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
119157|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119158|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119159|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
119160|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Total number of patiets with each pathogen at baseline (summary only shows pathogens where N>/=10)
119161|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment. Number of favourable responses
119162|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment Number of favourable responses
119163|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
119164|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
119165|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
119166|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
119167|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours after last dose of study drug
119168|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours after last dose of study drug
119169|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
119170|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
119171|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
119172|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
119173|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours of last dose of study drug
119174|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours of last dose of study drug
119175|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119176|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119177|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119178|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119179|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119180|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119181|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119182|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119183|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
119184|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
119190|NCT01499277|P2|Participant Flow|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119191|NCT01499277|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119192|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119193|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119194|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119195|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119196|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119197|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119198|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119199|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119200|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119201|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119202|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119203|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119204|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119205|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119206|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119207|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119208|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119209|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119210|NCT01499277|E2|Reported Event|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
119211|NCT01499277|E1|Reported Event|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
119212|NCT01499199|B1|Baseline|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119213|NCT01499199|P1|Participant Flow|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119214|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119215|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119216|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119217|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119218|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119219|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119220|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119221|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119222|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119223|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119224|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119225|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119226|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119227|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119228|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119229|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119230|NCT01499199|E1|Reported Event|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
119231|NCT01499134|B3|Baseline|Total|Total of all reporting groups
119232|NCT01499134|B2|Baseline|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119233|NCT01499134|B1|Baseline|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119292|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119293|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119234|NCT01499134|P2|Participant Flow|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119235|NCT01499134|P1|Participant Flow|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119236|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119237|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119238|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119239|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119240|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119241|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119242|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119243|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119244|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119245|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119246|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119247|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119248|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119249|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119250|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119294|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
136509|NCT01428765|E1|Reported Event|All Patients|
119251|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119252|NCT01499134|E2|Reported Event|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
119253|NCT01499134|E1|Reported Event|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
119254|NCT01499095|B3|Baseline|Total|Total of all reporting groups
119255|NCT01499095|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119256|NCT01499095|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119257|NCT01499095|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
119258|NCT01499095|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
119259|NCT01499095|O2|Outcome|HOE901­U300: Fixed Dosing Intervals|HOE901­U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 participants received HOE901­U300 once daily every 24 hours.
119260|NCT01499095|O1|Outcome|HOE901­U300: Adaptable Dosing Intervals|HOE901­U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 participants received HOE901­U300 once daily at intervals of 24 +/­ 3 hours.
119261|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119262|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119263|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119264|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119265|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119266|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119267|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119268|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119269|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119270|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119271|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119272|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119273|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119274|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119275|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119276|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119277|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on in combination with antidiabetic drug(s).
119278|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119279|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119280|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119281|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119282|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119283|NCT01499095|E2|Reported Event|LANTUS|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119284|NCT01499095|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
119285|NCT01499082|B3|Baseline|Total|Total of all reporting groups
119286|NCT01499082|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119287|NCT01499082|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119288|NCT01499082|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
119289|NCT01499082|P1|Participant Flow|HOE901-U300|HOE901­U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.
119290|NCT01499082|O2|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
119291|NCT01499082|O1|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
119295|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119296|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119297|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119298|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119299|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119300|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119301|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119302|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119303|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119304|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119305|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119306|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119307|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119308|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119309|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119310|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119311|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119312|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119313|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119314|NCT01499082|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
119315|NCT01499082|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
119316|NCT01498822|B3|Baseline|Total Title|
119317|NCT01498822|B2|Baseline|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
119318|NCT01498822|B1|Baseline|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
119319|NCT01498822|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
119320|NCT01498822|P1|Participant Flow|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
119321|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
119322|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
119323|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
119324|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
119325|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
119326|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
119327|NCT01498822|O2|Outcome|Per Protocol Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
119328|NCT01498822|O1|Outcome|Per Protocol Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
119329|NCT01498822|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
119330|NCT01498822|E1|Reported Event|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
119331|NCT01498744|B3|Baseline|Total|Total of all reporting groups
119332|NCT01498744|B2|Baseline|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119384|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119385|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119386|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
136897|NCT01426789|P2|Participant Flow|Placebo|Placebo i.v.
119333|NCT01498744|B1|Baseline|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119334|NCT01498744|P2|Participant Flow|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119335|NCT01498744|P1|Participant Flow|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119336|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119337|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119338|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119339|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119340|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119341|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119342|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119343|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119387|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119388|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119389|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119344|NCT01498744|E2|Reported Event|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119345|NCT01498744|E1|Reported Event|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
119346|NCT01498692|B1|Baseline|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119347|NCT01498692|P1|Participant Flow|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119348|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119349|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119350|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119351|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119352|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119353|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119354|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119355|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119356|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119357|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119358|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119359|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119360|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119361|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119362|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119363|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119364|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119365|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119366|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119367|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119368|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119369|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119370|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119371|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119372|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119373|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119374|NCT01498692|E1|Reported Event|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
119375|NCT01498679|B3|Baseline|Total|Total of all reporting groups
119376|NCT01498679|B2|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119377|NCT01498679|B1|Baseline|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119378|NCT01498679|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 100/25 micrograms (µg) OD in the evening,via a DPI, for a period of 12 weeks.
119379|NCT01498679|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119380|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119381|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119382|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119383|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119536|NCT01498185|O4|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119390|NCT01498679|E2|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
119391|NCT01498679|E1|Reported Event|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
119392|NCT01498653|B3|Baseline|Total|Total of all reporting groups
119393|NCT01498653|B2|Baseline|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119394|NCT01498653|B1|Baseline|Fluticasone Furoate/Vilanterol 200/25 µg OD|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119395|NCT01498653|P2|Participant Flow|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119396|NCT01498653|P1|Participant Flow|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119397|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119398|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119399|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119400|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119401|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119402|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119403|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119404|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119405|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119406|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119407|NCT01498653|E2|Reported Event|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
119408|NCT01498653|E1|Reported Event|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
119409|NCT01498640|B1|Baseline|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
119410|NCT01498640|P1|Participant Flow|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
119411|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
119412|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
119413|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
119414|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
119415|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
119416|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
119417|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
119418|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
119419|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
119420|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
119421|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
119422|NCT01498640|E1|Reported Event|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
119423|NCT01498601|B3|Baseline|Total|Total of all reporting groups
119424|NCT01498601|B2|Baseline|Retrospective Study Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
119425|NCT01498601|B1|Baseline|Oral Care Treatment Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
119458|NCT01498419|B2|Baseline|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119426|NCT01498601|P2|Participant Flow|Oral Care Treatment Group|"All subjects in the intervention group received the enhanced oral care protocol:~Changing mouth suction equipment every 24 hours~Mouth assessment every 2-4 hours~Cleansing mouth with toothbrush every 12 hours~Cleansing oral mucosa with oral rinse solution every 2-4 hours~Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours~Suction mouth and throat as needed~Head of the bed elevated to a minimum of 30° during oral care"
119427|NCT01498601|P1|Participant Flow|Retrospective Study Group|A retrospective chart review identified matched in-patients meeting the study inclusion criteria.
119428|NCT01498601|O2|Outcome|Retrospective Study Group|Acute neurologically impaired adults in the retrospective chart review
119429|NCT01498601|O1|Outcome|Oral Care Treatment Group|Acute neurologically impaired adults receiving the study protocol
119430|NCT01498601|E2|Reported Event|Retrospective Study Group|Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
119431|NCT01498601|E1|Reported Event|Oral Care Treatment Group|Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.
119432|NCT01498588|B1|Baseline|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
119433|NCT01498588|P1|Participant Flow|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
119434|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
119435|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
119436|NCT01498588|E1|Reported Event|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
119437|NCT01498575|B3|Baseline|Total|Total of all reporting groups
119438|NCT01498575|B2|Baseline|Usual Practice|Use of typical supervised practice driving resources
119439|NCT01498575|B1|Baseline|Teen Driving Plan|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
119440|NCT01498575|P2|Participant Flow|Usual Practice (Control)|Use of typical supervised practice driving resources
119441|NCT01498575|P1|Participant Flow|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
119442|NCT01498575|O2|Outcome|Usual Practice (Control)|Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
119443|NCT01498575|O1|Outcome|Teen Driving Plan (TDP)|Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
119444|NCT01498575|E2|Reported Event|Usual Practice (Control)|Use of typical supervised practice driving resources
119445|NCT01498575|E1|Reported Event|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
119446|NCT01498458|B1|Baseline|Pazopanib Plus Capecitabine|pazopanib plus capecitabine
119447|NCT01498458|P1|Participant Flow|Pazopanib Plus Capecitabine|The baseline refers only to the 8 patients who received Pazopanib.
119448|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|2 patients were on study treatment for a long time.
119449|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|
119450|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|pazopanib together with capecitabine
119451|NCT01498458|O1|Outcome|Pazopanib + Capecitabine|Pazopanib and Capecitabine
119452|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|The following DLTs resulted in permanent discontinuation of the study therapy: hypertension, (DLT 1), mucositis CTC grade 3, hand-foot-syndrome CTC grade 3, increase of liver enzymes (GOT,- and GPT) CTC grade 2 (DLT 2), and increase of liver enzymes (GOT-, GPT) CTC grade 3 (DLT 3).
119453|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
119454|NCT01498458|E1|Reported Event|Pazopanib Plus Capecitabine|There was only one arm in this study as this was a dose escalation study.
119455|NCT01498419|B5|Baseline|Total|Total of all reporting groups
119456|NCT01498419|B4|Baseline|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119457|NCT01498419|B3|Baseline|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
137964|NCT01422213|E2|Reported Event|Vortioxetine 10 mg|
119459|NCT01498419|B1|Baseline|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119460|NCT01498419|P4|Participant Flow|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119461|NCT01498419|P3|Participant Flow|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119462|NCT01498419|P2|Participant Flow|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119463|NCT01498419|P1|Participant Flow|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119464|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119465|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119466|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119467|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119468|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119469|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119470|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119471|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119472|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119473|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119474|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119475|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119476|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119477|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119478|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119479|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119480|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119481|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119482|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119483|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119484|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119534|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119535|NCT01498185|O5|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119485|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119486|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119487|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119488|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119489|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119490|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119491|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119492|NCT01498419|E4|Reported Event|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119493|NCT01498419|E3|Reported Event|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
119494|NCT01498419|E2|Reported Event|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119495|NCT01498419|E1|Reported Event|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
119496|NCT01498185|B6|Baseline|Total|Total of all reporting groups
119497|NCT01498185|B5|Baseline|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119498|NCT01498185|B4|Baseline|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119499|NCT01498185|B3|Baseline|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119500|NCT01498185|B2|Baseline|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119501|NCT01498185|B1|Baseline|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
119502|NCT01498185|P5|Participant Flow|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119503|NCT01498185|P4|Participant Flow|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119504|NCT01498185|P3|Participant Flow|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119505|NCT01498185|P2|Participant Flow|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119506|NCT01498185|P1|Participant Flow|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
119507|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119508|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119509|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119510|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119511|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119512|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119513|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119514|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119515|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119516|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119517|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119518|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119519|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119520|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119521|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119522|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119523|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119524|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119525|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119526|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119527|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119528|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119529|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119530|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119531|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119532|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119533|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
137965|NCT01422213|E1|Reported Event|Placebo|
119537|NCT01498185|O3|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119538|NCT01498185|O2|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119539|NCT01498185|O1|Outcome|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
119540|NCT01498185|E5|Reported Event|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
119541|NCT01498185|E4|Reported Event|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119542|NCT01498185|E3|Reported Event|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
119543|NCT01498185|E2|Reported Event|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
119544|NCT01498185|E1|Reported Event|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
119545|NCT01498120|B1|Baseline|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
119546|NCT01498120|P1|Participant Flow|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
119547|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
119548|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
119549|NCT01498120|E1|Reported Event|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
119550|NCT01498068|B3|Baseline|Total|Total of all reporting groups
119551|NCT01498068|B2|Baseline|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119552|NCT01498068|B1|Baseline|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119553|NCT01498068|P2|Participant Flow|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119554|NCT01498068|P1|Participant Flow|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119555|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119556|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119557|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119558|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119559|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119560|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119628|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119561|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119562|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119563|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119564|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119565|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119566|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119567|NCT01498068|E2|Reported Event|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119568|NCT01498068|E1|Reported Event|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
119569|NCT01497938|B3|Baseline|Total|Total of all reporting groups
119570|NCT01497938|B2|Baseline|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
119571|NCT01497938|B1|Baseline|Low Glucose Suspend Feature (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
119572|NCT01497938|P2|Participant Flow|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
119573|NCT01497938|P1|Participant Flow|Low Glucose Suspend Feasure (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
119574|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
119575|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
119576|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
119577|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
119578|NCT01497938|E2|Reported Event|Group B Without Low Glucose Suspend (LGS) Feature|
119579|NCT01497938|E1|Reported Event|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
119580|NCT01497899|B5|Baseline|Total|Total of all reporting groups
119581|NCT01497899|B4|Baseline|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
119582|NCT01497899|B3|Baseline|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
119583|NCT01497899|B2|Baseline|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119584|NCT01497899|B1|Baseline|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119585|NCT01497899|P4|Participant Flow|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received darunavir (DRV) + cobicistat (COBI) + truvada (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
119586|NCT01497899|P3|Participant Flow|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
119629|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119587|NCT01497899|P2|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119588|NCT01497899|P1|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119589|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119590|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119591|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119592|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119593|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119594|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119595|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119596|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119597|NCT01497899|E3|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.~Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119598|NCT01497899|E2|Reported Event|E/C/F/TDF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.~Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119599|NCT01497899|E1|Reported Event|E/C/F/TAF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.~Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
119600|NCT01497756|B1|Baseline|CAPP Application|Patients in whom device is used
119601|NCT01497756|P1|Participant Flow|CAPP Application|Patients in whom device is used
119602|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
119603|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
119604|NCT01497756|E1|Reported Event|CAPP Application|Patients in whom device is used
119605|NCT01497665|B1|Baseline|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119606|NCT01497665|P1|Participant Flow|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119607|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119608|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119609|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119610|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119611|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119612|NCT01497665|E1|Reported Event|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
119613|NCT01497366|B3|Baseline|Total|Total of all reporting groups
119614|NCT01497366|B2|Baseline|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119615|NCT01497366|B1|Baseline|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119616|NCT01497366|P2|Participant Flow|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119617|NCT01497366|P1|Participant Flow|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
119618|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119619|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119620|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119621|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119622|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119623|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
119624|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119625|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
119626|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119627|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119630|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119631|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119632|NCT01497366|E2|Reported Event|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
119633|NCT01497366|E1|Reported Event|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
119634|NCT01497275|B1|Baseline|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119635|NCT01497275|P1|Participant Flow|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119636|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119637|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119638|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119639|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119640|NCT01497275|E1|Reported Event|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
119641|NCT01497262|B1|Baseline|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
119642|NCT01497262|P1|Participant Flow|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
119643|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
119644|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
119645|NCT01497262|E1|Reported Event|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
119646|NCT01497197|B3|Baseline|Total|Total of all reporting groups
119647|NCT01497197|B2|Baseline|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119648|NCT01497197|B1|Baseline|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119649|NCT01497197|P2|Participant Flow|Gonal-f® Followed by Luveris|GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
119650|NCT01497197|P1|Participant Flow|Gonal-f®+Luveris|GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
119651|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
122221|NCT01486615|B2|Baseline|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
119652|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119653|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119654|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119655|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119656|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119657|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119658|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119659|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119660|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119661|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119662|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119663|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119664|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119665|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119666|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119740|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119741|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119667|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119668|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119669|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119670|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119671|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119672|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119673|NCT01497197|E2|Reported Event|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119674|NCT01497197|E1|Reported Event|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
119675|NCT01497171|B3|Baseline|Total|Total of all reporting groups
119676|NCT01497171|B2|Baseline|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
119677|NCT01497171|B1|Baseline|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
119678|NCT01497171|P2|Participant Flow|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
119679|NCT01497171|P1|Participant Flow|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
119680|NCT01497171|O2|Outcome|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
119681|NCT01497171|O1|Outcome|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
119682|NCT01497171|E2|Reported Event|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
119683|NCT01497171|E1|Reported Event|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
119684|NCT01496469|B3|Baseline|Total|Total of all reporting groups
119685|NCT01496469|B2|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119686|NCT01496469|B1|Baseline|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119687|NCT01496469|P2|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119688|NCT01496469|P1|Participant Flow|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119689|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119690|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119691|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119692|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119693|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119694|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119695|NCT01496469|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
119696|NCT01496469|E1|Reported Event|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
119742|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119743|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119697|NCT01496456|B1|Baseline|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements"
119698|NCT01496456|P1|Participant Flow|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).~A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.~––– Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements."
119699|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
119700|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
119701|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
119702|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
119703|NCT01496456|O2|Outcome|Preventative Measures|SOC Caries management by preventative measures only.
119704|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
119705|NCT01496456|E2|Reported Event|Preventative Measures|"Caries management by preventative measures only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
119706|NCT01496456|E1|Reported Event|Lesion Infiltration|"Resin infiltration of caries lesion in addition to SOC caries management by preventative measures~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
119707|NCT01496430|B4|Baseline|Total|Total of all reporting groups
119708|NCT01496430|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119709|NCT01496430|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119710|NCT01496430|B1|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119711|NCT01496430|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119712|NCT01496430|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119713|NCT01496430|P1|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119714|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119715|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119716|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119717|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119718|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119719|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119720|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119721|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119722|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119723|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119724|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119725|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119726|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119727|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119728|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119729|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119730|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119731|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119732|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119733|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119734|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119735|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119736|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119737|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119738|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119739|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
137966|NCT01422187|B4|Baseline|Total|Total of all reporting groups
119744|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119745|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119746|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119747|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119748|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119749|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119750|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119751|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119752|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119753|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119754|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119755|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119756|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119757|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119758|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119759|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119760|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119761|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119762|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119763|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119764|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119765|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119766|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119767|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119768|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119769|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119770|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119771|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119772|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119773|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119774|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119775|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119776|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119777|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119778|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119779|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119780|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119781|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119782|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119783|NCT01496430|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
119784|NCT01496430|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
119785|NCT01496430|E1|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
119786|NCT01496352|B3|Baseline|Total|Total of all reporting groups
119787|NCT01496352|B2|Baseline|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
119788|NCT01496352|B1|Baseline|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
119789|NCT01496352|P2|Participant Flow|DFA-02 Placebo|Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
119790|NCT01496352|P1|Participant Flow|DFA-02|"Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02~DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure"
119791|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
119792|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL DFA-02
122222|NCT01486615|B1|Baseline|Melatonin|premedication 1-2 hour prior to anesthesia
119793|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subject per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
119794|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
119795|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving 10, 20 or 30 mL DFA-02 placebo
119796|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
119797|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 and 30 mL of DFA-02 placebo
119798|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 18 subjects receiving up to 10, 20 or 30 mL of DFA-02
119799|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
119800|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
119801|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
119802|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
119803|NCT01496352|E2|Reported Event|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
119804|NCT01496352|E1|Reported Event|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
119805|NCT01496313|B3|Baseline|Total|Total of all reporting groups
119806|NCT01496313|B2|Baseline|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119807|NCT01496313|B1|Baseline|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119808|NCT01496313|P2|Participant Flow|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119809|NCT01496313|P1|Participant Flow|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119810|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119811|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119812|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119813|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119814|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119815|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119816|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119817|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119818|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119819|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119820|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119821|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119822|NCT01496313|E2|Reported Event|Vandetanib 300 mg|Oral blinded tablet, taken once daily
119823|NCT01496313|E1|Reported Event|Vandetanib 150 mg|Oral blinded tablet, taken once daily
119824|NCT01496287|B1|Baseline|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119825|NCT01496287|P1|Participant Flow|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
119826|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119827|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119828|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119829|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119830|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119831|NCT01496287|E1|Reported Event|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
119832|NCT01496274|B3|Baseline|Total|Total of all reporting groups
119833|NCT01496274|B2|Baseline|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
119834|NCT01496274|B1|Baseline|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
119835|NCT01496274|P2|Participant Flow|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119836|NCT01496274|P1|Participant Flow|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119837|NCT01496274|O3|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
119838|NCT01496274|O2|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
119839|NCT01496274|O1|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
119840|NCT01496274|O1|Outcome|Surgical Population|The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
119841|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119842|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119843|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119844|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119845|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119846|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119847|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119848|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119849|NCT01496274|O4|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
119850|NCT01496274|O3|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
119851|NCT01496274|O2|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
119852|NCT01496274|O1|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
119853|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119854|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119855|NCT01496274|O3|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
119856|NCT01496274|O2|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
119857|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119858|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
119859|NCT01496274|O3|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
119860|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119861|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119862|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
119863|NCT01496274|O2|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
119864|NCT01496274|O1|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
119865|NCT01496274|E2|Reported Event|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119866|NCT01496274|E1|Reported Event|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
119867|NCT01496248|B1|Baseline|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119868|NCT01496248|P1|Participant Flow|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119869|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119870|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119871|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119872|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119873|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119874|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119875|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119876|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119877|NCT01496248|E1|Reported Event|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
119878|NCT01496183|B3|Baseline|Total|Total of all reporting groups
119879|NCT01496183|B2|Baseline|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
119880|NCT01496183|B1|Baseline|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
119881|NCT01496183|P2|Participant Flow|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
119882|NCT01496183|P1|Participant Flow|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
119883|NCT01496183|O2|Outcome|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
119884|NCT01496183|O1|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.
119885|NCT01496183|E2|Reported Event|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
119886|NCT01496183|E1|Reported Event|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
119887|NCT01495975|B3|Baseline|Total|Total of all reporting groups
119888|NCT01495975|B2|Baseline|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
119889|NCT01495975|B1|Baseline|Usual Care|Usual care for diabetes in the 1 month after discharge.
119890|NCT01495975|P2|Participant Flow|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
119891|NCT01495975|P1|Participant Flow|Usual Care|Usual care for diabetes in the 1 month after discharge.
119892|NCT01495975|O2|Outcome|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
119893|NCT01495975|O1|Outcome|Usual Care|Usual care for diabetes in the 1 month after discharge.
119894|NCT01495975|E2|Reported Event|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
119895|NCT01495975|E1|Reported Event|Usual Care|Usual care for diabetes in the 1 month after discharge.
119896|NCT01495858|B4|Baseline|Total|Total of all reporting groups
119897|NCT01495858|B3|Baseline|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119898|NCT01495858|B2|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119899|NCT01495858|B1|Baseline|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119900|NCT01495858|P3|Participant Flow|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119901|NCT01495858|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119902|NCT01495858|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119903|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119904|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119905|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119906|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119907|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119908|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119909|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119910|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119911|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119912|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119913|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119914|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119915|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119916|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119917|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119918|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119919|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119920|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119921|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119922|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119923|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119924|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119925|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119926|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119927|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119928|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119929|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119930|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119931|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119932|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119933|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119934|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119935|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119936|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119937|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119938|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119939|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119940|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119941|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119942|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119943|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119944|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119945|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119946|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119947|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119948|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119949|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119950|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119951|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119952|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119953|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119954|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119955|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119956|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119957|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119958|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119959|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119960|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119961|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119962|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119963|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119964|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119965|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119966|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119967|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119968|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119969|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119970|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119971|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119972|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119973|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
119974|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119975|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119976|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
139747|NCT01410474|B3|Baseline|Total|Total of all reporting groups
119977|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
119978|NCT01495858|E3|Reported Event|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
119979|NCT01495858|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
119980|NCT01495858|E1|Reported Event|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally
119981|NCT01495793|B1|Baseline|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119982|NCT01495793|P1|Participant Flow|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119983|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119984|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119985|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119986|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119987|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119988|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119989|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119990|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119991|NCT01495793|E1|Reported Event|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
119992|NCT01495702|B3|Baseline|Total|Total of all reporting groups
119993|NCT01495702|B2|Baseline|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
119994|NCT01495702|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
119995|NCT01495702|P2|Participant Flow|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
119996|NCT01495702|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
119997|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
119998|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
119999|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
120000|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
120001|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
120002|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
120003|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
120004|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
120005|NCT01495702|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
120064|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120006|NCT01495702|E2|Reported Event|NNRTI+FTC/TDF (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
120007|NCT01495702|E1|Reported Event|Stribild (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
120008|NCT01495585|B4|Baseline|Total|Total of all reporting groups
120009|NCT01495585|B3|Baseline|Lonafarnib 200 mg|"4 participants were randomized to Lonafarnib 200 mg and two Placebo participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg ."
120010|NCT01495585|B2|Baseline|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
120011|NCT01495585|B1|Baseline|Placebo|placebo control.
120012|NCT01495585|P3|Participant Flow|Lonafarnib 200 mg|4 participants were randomized to Lonafarnib 200 mg.
120013|NCT01495585|P2|Participant Flow|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
120014|NCT01495585|P1|Participant Flow|Placebo|Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
120015|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
120016|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
120017|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
120018|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
120019|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
120020|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
120021|NCT01495585|E3|Reported Event|Group 2|lonafarnib 200 mg
120022|NCT01495585|E2|Reported Event|Group 1|lonafarnib 100 mg
120023|NCT01495585|E1|Reported Event|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
120024|NCT01495572|B3|Baseline|Total|Total of all reporting groups
120025|NCT01495572|B2|Baseline|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120026|NCT01495572|B1|Baseline|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120027|NCT01495572|P2|Participant Flow|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120028|NCT01495572|P1|Participant Flow|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120029|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x1011 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120030|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120031|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120065|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
140580|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
120032|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120033|NCT01495572|E2|Reported Event|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120034|NCT01495572|E1|Reported Event|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
120035|NCT01495286|B1|Baseline|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120036|NCT01495286|P1|Participant Flow|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120037|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120038|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120039|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120040|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120041|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120066|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120807|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120042|NCT01495286|E1|Reported Event|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
120043|NCT01495000|B3|Baseline|Total|Total of all reporting groups
120044|NCT01495000|B2|Baseline|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120045|NCT01495000|B1|Baseline|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120046|NCT01495000|P2|Participant Flow|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120047|NCT01495000|P1|Participant Flow|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120048|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120049|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120050|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120051|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120052|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120053|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120054|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120055|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120056|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120057|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120058|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120059|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120060|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120061|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120062|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120063|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120839|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120067|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120068|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120069|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120070|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120071|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120072|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120073|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120074|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120075|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120076|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120077|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120078|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120079|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120080|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120081|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120082|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120083|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120084|NCT01495000|E2|Reported Event|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
120085|NCT01495000|E1|Reported Event|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
120086|NCT01494987|B3|Baseline|Total|Total of all reporting groups
120087|NCT01494987|B2|Baseline|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120134|NCT01494649|B2|Baseline|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120885|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120088|NCT01494987|B1|Baseline|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120089|NCT01494987|P2|Participant Flow|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120090|NCT01494987|P1|Participant Flow|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120091|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120092|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120093|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120094|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120095|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120096|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120097|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120098|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120099|NCT01494987|E2|Reported Event|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
120100|NCT01494987|E1|Reported Event|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
120101|NCT01494818|B3|Baseline|Total|Total of all reporting groups
120102|NCT01494818|B2|Baseline|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120103|NCT01494818|B1|Baseline|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120104|NCT01494818|P2|Participant Flow|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120105|NCT01494818|P1|Participant Flow|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120106|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120107|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120108|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120109|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120110|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120111|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120112|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120113|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120114|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120115|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120116|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120117|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120118|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120119|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120120|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120121|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120122|NCT01494818|E2|Reported Event|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120123|NCT01494818|E1|Reported Event|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
120124|NCT01494753|B3|Baseline|Total|Total of all reporting groups
120125|NCT01494753|B2|Baseline|T2345/Prostaglandin|One drop at 8.00pm.
120126|NCT01494753|B1|Baseline|Prostaglandin/T2345|One drop at 8.00pm.
120127|NCT01494753|P2|Participant Flow|T2345/Prostaglandin|One drop at 8.00pm.
120128|NCT01494753|P1|Participant Flow|Prostaglandin/T2345|One drop at 8.00pm.
120129|NCT01494753|O2|Outcome|T2345/Prostaglandin|One drop at 8.00pm.
120130|NCT01494753|O1|Outcome|Prostaglandin/T2345|One drop at 8.00pm.
120131|NCT01494753|E2|Reported Event|T2345|One drop at 8.00pm.
120132|NCT01494753|E1|Reported Event|Prostaglandin|One drop at 8.00pm.
120133|NCT01494649|B3|Baseline|Total|Total of all reporting groups
140581|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
120135|NCT01494649|B1|Baseline|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
120136|NCT01494649|P2|Participant Flow|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120137|NCT01494649|P1|Participant Flow|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
120138|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120139|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120140|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120141|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120142|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120143|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120144|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120145|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeths for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120146|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120147|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120148|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
120149|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
120150|NCT01494649|E2|Reported Event|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
120151|NCT01494649|E1|Reported Event|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product.
120152|NCT01494610|B1|Baseline|FP/Salmeterol 250/50 Mcg|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
120153|NCT01494610|P2|Participant Flow|FP/Salmeterol 250/50 Mcg: Sequence BAAB|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
120154|NCT01494610|P1|Participant Flow|FP/Salmeterol 250/50 Mcg: Sequence ABBA|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
120155|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120156|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120157|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120158|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
140582|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
120159|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120160|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120161|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120162|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120163|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120164|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120165|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120166|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120167|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120168|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120169|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120170|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120171|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120172|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120173|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120174|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120175|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120176|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120177|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120178|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120179|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120180|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120181|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120182|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120183|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120184|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120185|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120186|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120886|NCT01491633|E1|Reported Event|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120187|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120188|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120189|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120190|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120191|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120192|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120193|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120194|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120195|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120196|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120197|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120198|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120199|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120200|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120201|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120202|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120203|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120204|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120205|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120206|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120207|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120208|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120209|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120210|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120211|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
120212|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
120213|NCT01494610|E8|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
120214|NCT01494610|E7|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
120887|NCT01491607|B5|Baseline|Total|Total of all reporting groups
120215|NCT01494610|E6|Reported Event|FP/Salmeterol From MDPI 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
120216|NCT01494610|E5|Reported Event|FP/Salmeterol From MDPI 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
120217|NCT01494610|E4|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
120218|NCT01494610|E3|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
120219|NCT01494610|E2|Reported Event|FP/Salmeterol From MDPI 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
120220|NCT01494610|E1|Reported Event|FP/Salmeterol From MDPI 1st Administration (Admin), Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
120221|NCT01494584|B1|Baseline|Ezogabine/Retigabine|Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120222|NCT01494584|P1|Participant Flow|Ezogabine/Retigabine|Participants recieved an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120223|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120224|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120225|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120226|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120227|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120228|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120229|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120332|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
121909|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
120230|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120231|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120232|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120233|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120234|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120235|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120236|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120237|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120238|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120239|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120240|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120241|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120333|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120334|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120242|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120243|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120244|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120245|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R)300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120246|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120247|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120248|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly upitration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120249|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120250|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120251|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120252|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants recieved an initial dose of ezogabine/retigabine 300 mg/day administered as 100 mg IR tablets TID orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120253|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120266|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120254|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of>50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120255|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120256|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120257|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120258|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120259|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120260|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120261|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120262|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120263|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120264|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120265|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120327|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120328|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120267|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120268|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120269|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120270|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120271|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120272|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120273|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120274|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120275|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120276|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120277|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120278|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120329|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120588|NCT01494298|E2|Reported Event|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
120279|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120280|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120281|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120282|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120283|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120284|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120285|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120286|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120287|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120288|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120289|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120290|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120589|NCT01494298|E1|Reported Event|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
120291|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an uptitrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120292|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120293|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120294|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120295|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120296|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120297|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120298|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120299|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120300|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120301|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120302|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120330|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120331|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120590|NCT01493947|B3|Baseline|Total|Total of all reporting groups
120303|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120304|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants (par.) with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120305|NCT01494584|E5|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120306|NCT01494584|E4|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120307|NCT01494584|E3|Reported Event|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120308|NCT01494584|E2|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120309|NCT01494584|E1|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
120310|NCT01494545|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120311|NCT01494545|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120312|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120313|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120314|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120315|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120316|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120317|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120318|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120319|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
120320|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
120321|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120322|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
120323|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
120324|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120325|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
120326|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
122223|NCT01486615|P4|Participant Flow|Placebo|Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
120335|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120336|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120337|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120338|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120339|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120340|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120341|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120342|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120343|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120344|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120345|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120346|NCT01494545|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
120347|NCT01494532|B7|Baseline|Total|Total of all reporting groups
120348|NCT01494532|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120349|NCT01494532|B5|Baseline|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120350|NCT01494532|B4|Baseline|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120351|NCT01494532|B3|Baseline|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120352|NCT01494532|B2|Baseline|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120353|NCT01494532|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120354|NCT01494532|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120355|NCT01494532|P5|Participant Flow|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120356|NCT01494532|P4|Participant Flow|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
122224|NCT01486615|P3|Participant Flow|Alprazolam|Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia
120357|NCT01494532|P3|Participant Flow|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120358|NCT01494532|P2|Participant Flow|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120359|NCT01494532|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120360|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120361|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120362|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120363|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120364|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120365|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120366|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120367|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120368|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120369|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120370|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
122507|NCT01484652|B2|Baseline|Placebo|2 tablets taken every 12 hours
120371|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120372|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120373|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120374|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120375|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120376|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120377|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120378|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120379|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120380|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120381|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120382|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120383|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120384|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120591|NCT01493947|B2|Baseline|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
120385|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120386|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120387|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120388|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120389|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120390|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120391|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120392|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120393|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120394|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120395|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120396|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120397|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120398|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120399|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120400|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120401|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120402|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120403|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120404|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120405|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120406|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120407|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120408|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120409|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120410|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120411|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120412|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
122508|NCT01484652|B1|Baseline|COV795|2 tablets taken every 12 hours
120413|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120414|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120415|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120416|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120417|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120418|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120419|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120420|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120421|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120422|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120423|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120424|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120425|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120426|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120592|NCT01493947|B1|Baseline|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
120593|NCT01493947|P2|Participant Flow|Metronidazole 0.75% Cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week
120427|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120428|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120429|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120430|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120431|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120432|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120433|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120434|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120435|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120436|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120437|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120438|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120439|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120440|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120441|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120442|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120443|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120444|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120445|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120446|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120447|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120448|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120449|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120450|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120451|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120452|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120453|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120454|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120594|NCT01493947|P1|Participant Flow|Ivermectin|Ivermectin applied once daily on the face during 16-week
120455|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120456|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120457|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120458|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120459|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120460|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120461|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120462|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120463|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120464|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120465|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120466|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120467|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120468|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120595|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
120469|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120470|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120471|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120472|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120473|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120474|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120475|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120476|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120477|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120478|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120479|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120480|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120481|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120482|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120483|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120484|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120485|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120486|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120487|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120488|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120489|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120490|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120491|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120492|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120493|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120494|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120495|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120496|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120596|NCT01493947|O1|Outcome|CD5024|CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
120497|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120498|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120499|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120500|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120501|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120502|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120503|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120504|NCT01494532|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120505|NCT01494532|E5|Reported Event|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120506|NCT01494532|E4|Reported Event|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120507|NCT01494532|E3|Reported Event|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120508|NCT01494532|E2|Reported Event|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
120509|NCT01494532|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
120510|NCT01494506|B4|Baseline|Total|Total of all reporting groups
120511|NCT01494506|B3|Baseline|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
120597|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
140583|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
120512|NCT01494506|B2|Baseline|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
120513|NCT01494506|B1|Baseline|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
120514|NCT01494506|P3|Participant Flow|MM-398 + 5-FU + Leucovorin (Arm C)|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120515|NCT01494506|P2|Participant Flow|5-FU + Leucovorin (Arm B)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120516|NCT01494506|P1|Participant Flow|MM-398 (Arm A)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120517|NCT01494506|O2|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120518|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120519|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120520|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120521|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120522|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120523|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120524|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120525|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120526|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120527|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120528|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120598|NCT01493947|O1|Outcome|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
120529|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120530|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120531|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120532|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120533|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120534|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120535|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120536|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120537|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120538|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120539|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120540|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120541|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120542|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120543|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
120544|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
120545|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
140584|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
120546|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
120547|NCT01494506|E3|Reported Event|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
120548|NCT01494506|E2|Reported Event|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
120549|NCT01494506|E1|Reported Event|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
120550|NCT01494467|B3|Baseline|Total|Total of all reporting groups
120551|NCT01494467|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
120552|NCT01494467|B1|Baseline|CD5024 1% Cream|"Part A: CD5024 1% Cream, once daily application for 12 weeks~Part B: CD5024 1% Cream, once daily application for 40 weeks"
120553|NCT01494467|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
120554|NCT01494467|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
120555|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120556|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
120557|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120558|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
120559|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120560|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
120561|NCT01494467|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
120562|NCT01494467|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
120563|NCT01494467|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
120564|NCT01494467|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
120565|NCT01494467|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
120566|NCT01494467|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
120567|NCT01494467|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
120568|NCT01494467|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
120569|NCT01494350|B1|Baseline|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120570|NCT01494350|P1|Participant Flow|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120571|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120572|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120573|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120574|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120575|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120576|NCT01494350|E1|Reported Event|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
120577|NCT01494298|B3|Baseline|Total|Total of all reporting groups
120578|NCT01494298|B2|Baseline|Controls|African American Men without diabetes
120579|NCT01494298|B1|Baseline|T2DM|African American Men with Type 2 Diabetes
120580|NCT01494298|P2|Participant Flow|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
120581|NCT01494298|P1|Participant Flow|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
120582|NCT01494298|O2|Outcome|Controls|
120583|NCT01494298|O1|Outcome|T2DM|
120584|NCT01494298|O2|Outcome|Controls|African-American men without type 2 diabetes who are not taking cholesterol lowering medications
120585|NCT01494298|O1|Outcome|T2DM|African-American men with type 2 diabetes who are not taking cholesterol lowering medications
120586|NCT01494298|O2|Outcome|Controls|
120587|NCT01494298|O1|Outcome|T2DM|
140585|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
120599|NCT01493947|E4|Reported Event|Metronidazole 0.75% Cream Period B|36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
120600|NCT01493947|E3|Reported Event|Ivermectin 1% Cream Period B|36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible
120601|NCT01493947|E2|Reported Event|Metronidazole 0.75% Cream Period A|Metronidazole 0.75% cream applied twice daily on the face during 16-week
120602|NCT01493947|E1|Reported Event|Ivermectin 1% Cream Period A|Ivermectin applied once daily on the face during 16-week
120603|NCT01493687|B3|Baseline|Total|Total of all reporting groups
120604|NCT01493687|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
120605|NCT01493687|B1|Baseline|CD5024 1% Cream|Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
120606|NCT01493687|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
120607|NCT01493687|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
120608|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120609|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
120610|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120611|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
120612|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
120613|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
120614|NCT01493687|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
120615|NCT01493687|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
120616|NCT01493687|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
120617|NCT01493687|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
120618|NCT01493687|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
120619|NCT01493687|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
120620|NCT01493687|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
120621|NCT01493687|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
120622|NCT01493557|B4|Baseline|Total|Total of all reporting groups
120623|NCT01493557|B3|Baseline|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
120624|NCT01493557|B2|Baseline|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120625|NCT01493557|B1|Baseline|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120626|NCT01493557|P3|Participant Flow|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
120627|NCT01493557|P2|Participant Flow|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120628|NCT01493557|P1|Participant Flow|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120629|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120630|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120631|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120632|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120633|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120634|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120635|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120804|NCT01491919|P1|Participant Flow|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120636|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120637|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120638|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120639|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120640|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120641|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120642|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120643|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120644|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120645|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120646|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120647|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120648|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120649|NCT01493557|E3|Reported Event|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
120650|NCT01493557|E2|Reported Event|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
120651|NCT01493557|E1|Reported Event|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
120652|NCT01493531|B4|Baseline|Total|Total of all reporting groups
120653|NCT01493531|B3|Baseline|Placebo + Allopurinol|
120654|NCT01493531|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120655|NCT01493531|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120656|NCT01493531|P3|Participant Flow|Placebo + Allopurinol|
120657|NCT01493531|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120658|NCT01493531|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120659|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
120660|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120661|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120662|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
120663|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120664|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120665|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
120666|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120667|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120668|NCT01493531|E3|Reported Event|Placebo + Allopurinol|
120669|NCT01493531|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
120670|NCT01493531|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
120671|NCT01493427|B1|Baseline|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
120672|NCT01493427|P1|Participant Flow|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
120673|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
120674|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
120675|NCT01493427|E1|Reported Event|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
120676|NCT01493180|B3|Baseline|Total|Total of all reporting groups
120677|NCT01493180|B2|Baseline|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
120678|NCT01493180|B1|Baseline|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
120679|NCT01493180|P2|Participant Flow|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
120680|NCT01493180|P1|Participant Flow|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
120681|NCT01493180|O2|Outcome|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
120682|NCT01493180|O1|Outcome|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
120683|NCT01493180|E2|Reported Event|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
120684|NCT01493180|E1|Reported Event|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
120685|NCT01493167|B1|Baseline|Woodcast Circular System Casts|Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
120686|NCT01493167|P1|Participant Flow|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
120687|NCT01493167|O1|Outcome|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
120688|NCT01493167|E1|Reported Event|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
120689|NCT01493089|B3|Baseline|Total|Total of all reporting groups
120690|NCT01493089|B2|Baseline|Losec|Treatment of heartburn with Losec
120691|NCT01493089|B1|Baseline|Zegerid|Treatment of heartburn with Zegerid
120692|NCT01493089|P2|Participant Flow|Losec|Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
120693|NCT01493089|P1|Participant Flow|Zegerid|Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day
120694|NCT01493089|O2|Outcome|Losec Group|
120695|NCT01493089|O1|Outcome|Zegerid Group|
120696|NCT01493089|O2|Outcome|Losec Group|
120697|NCT01493089|O1|Outcome|Zegerid Group|
120698|NCT01493089|O2|Outcome|Losec Group|
120699|NCT01493089|O1|Outcome|Zegerid Group|
120700|NCT01493089|O2|Outcome|Losec Group|
120701|NCT01493089|O1|Outcome|Zegerid Group|
120702|NCT01493089|O2|Outcome|Losec Group|
120703|NCT01493089|O1|Outcome|Zegerid Group|
120704|NCT01493089|O2|Outcome|Losec Group|20mg Losec over-encapsulated capsule plus placebo suspension
120705|NCT01493089|O1|Outcome|Zegerid Group|20mg Zegerid suspension plus over-encapsulated placebo capsule
120706|NCT01493089|E2|Reported Event|Losec|Treatment of heartburn with Losec
120707|NCT01493089|E1|Reported Event|Zegerid|Treatment of heartburn with Zegerid
120708|NCT01492439|B3|Baseline|Total|Total of all reporting groups
120709|NCT01492439|B2|Baseline|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120710|NCT01492439|B1|Baseline|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120711|NCT01492439|P2|Participant Flow|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120712|NCT01492439|P1|Participant Flow|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120713|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120714|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120715|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120716|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120717|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120718|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120719|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120720|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120721|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120722|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120723|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120724|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120725|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120726|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120727|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120728|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120729|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120730|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120731|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120732|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120733|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120734|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120735|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120736|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120737|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120738|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120739|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120740|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120741|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120742|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120743|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120744|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120745|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120746|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120747|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120748|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120749|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120750|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120751|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120752|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120753|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120805|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120754|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120755|NCT01492439|E2|Reported Event|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
120756|NCT01492439|E1|Reported Event|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
120757|NCT01492426|B3|Baseline|Total|Total of all reporting groups
120758|NCT01492426|B2|Baseline|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120759|NCT01492426|B1|Baseline|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120760|NCT01492426|P2|Participant Flow|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120761|NCT01492426|P1|Participant Flow|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120762|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
120763|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120764|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120765|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120766|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120767|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120768|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200mg per day was administered twice daily with food.
120769|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120770|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120806|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
140586|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
120771|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120772|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
120773|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
120774|NCT01492426|E2|Reported Event|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
120775|NCT01492426|E1|Reported Event|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
120776|NCT01492400|B3|Baseline|Total|Total of all reporting groups
120777|NCT01492400|B2|Baseline|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120778|NCT01492400|B1|Baseline|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120779|NCT01492400|P2|Participant Flow|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120780|NCT01492400|P1|Participant Flow|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120781|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120782|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120783|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120784|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120785|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120786|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120787|NCT01492400|E2|Reported Event|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
120788|NCT01492400|E1|Reported Event|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
120789|NCT01491984|B3|Baseline|Total|Total of all reporting groups
120790|NCT01491984|B2|Baseline|Intubation Order MAC/Levitan|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
120791|NCT01491984|B1|Baseline|Intubation Order Levitan/MAC|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
120792|NCT01491984|P2|Participant Flow|Macintosh/Levitan FPS Laryngoscope Intubation Order|"traditional MAC intubation~laryngoscopy view with MAC :"
120793|NCT01491984|P1|Participant Flow|Levitan FPS/Mac Laryngoscope Intubation Order|"Intubation with Levitan~laryngoscopy view with Levitan :"
120794|NCT01491984|O2|Outcome|MAC/Levitan Intubation|Laryngoscopy with MAC then Levitan
120795|NCT01491984|O1|Outcome|Levitan/MAC Intubation|Laryngoscopy with Levitan, then MAC
120796|NCT01491984|E2|Reported Event|Macintosh Intubation|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
120797|NCT01491984|E1|Reported Event|Levitan FPS Intubation|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
120798|NCT01491919|B4|Baseline|Total|Total of all reporting groups
120799|NCT01491919|B3|Baseline|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120800|NCT01491919|B2|Baseline|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120801|NCT01491919|B1|Baseline|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120802|NCT01491919|P3|Participant Flow|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120803|NCT01491919|P2|Participant Flow|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120808|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120809|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120810|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120811|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120812|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120813|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120814|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120815|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120816|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120817|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120818|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120819|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120820|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120821|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120822|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120823|NCT01491919|O2|Outcome|Lisinopril Standard of Care (SOC)|These protocol participants were enrolled and continued on the lisinopril dose prescribed as standard of care. They were assigned to the appropriate eGFR and dose level stratum (rounding to the closest dose level). Since the lisinopril dose was assigned based on standard of care, a patient was enrolled without regard to open/closed status of the dose stratum in this group. Therefore, over enrollment of a specific dose and eGFR stratum was allowed for participants enrolled he the Lisinopril-naive group to accommodate these valuable low-risk participants already taking lisinopril.
120824|NCT01491919|O1|Outcome|Lisinopril-naive|These protocol participants were not randomized. Instead, the older age group (7-17 years) were first enrolled consecutively into each dose level, starting with the lowest dose level (0.1 mg/kg per day). After enrollment is complete in the low dose level for an eGFR strata, enrollment will commence for the intermediate (0.2 mg/kg per day) dosage in that strata, followed by the high (0.4 mg/kg per day) dosage level. Enrollment for the 2-6 years age group did not begin until enrollment in the older age group (7-17 years) for the low and intermediate dosage level at each eGFR strata is complete.
120825|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120826|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120827|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120828|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120829|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120830|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120831|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120832|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120833|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120834|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120835|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120836|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120837|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120838|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
126024|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
120840|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120841|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120842|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120843|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120844|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120845|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120846|NCT01491919|E3|Reported Event|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
120847|NCT01491919|E2|Reported Event|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
120848|NCT01491919|E1|Reported Event|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
120849|NCT01491672|B4|Baseline|Total|Total of all reporting groups
120850|NCT01491672|B3|Baseline|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120851|NCT01491672|B2|Baseline|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120852|NCT01491672|B1|Baseline|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120853|NCT01491672|P3|Participant Flow|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120854|NCT01491672|P2|Participant Flow|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120855|NCT01491672|P1|Participant Flow|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120856|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
120857|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120858|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120859|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120860|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
120861|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120862|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120863|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120864|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
120865|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120866|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120867|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120868|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
120869|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120870|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120871|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120872|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120873|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120874|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120875|NCT01491672|O1|Outcome|All Participants|All participants received RAD001 10 mg daily.
120876|NCT01491672|E3|Reported Event|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
120877|NCT01491672|E2|Reported Event|Other Prior Anti VEGF|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
120878|NCT01491672|E1|Reported Event|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
120879|NCT01491633|B1|Baseline|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120880|NCT01491633|P1|Participant Flow|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120881|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120882|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120883|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120884|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
120888|NCT01491607|B4|Baseline|BioThrax - Site 04|Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
120889|NCT01491607|B3|Baseline|BioThrax - Site 03|Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
120890|NCT01491607|B2|Baseline|BioThrax - Site 02|Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
120891|NCT01491607|B1|Baseline|BioThrax - Site 01|Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
120892|NCT01491607|P1|Participant Flow|BioThrax|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
120893|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120894|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120895|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120896|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120897|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120898|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120899|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120900|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120901|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120902|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120903|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120904|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120905|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120906|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120907|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120908|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120909|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120910|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120911|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120912|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120913|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120914|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120915|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120916|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120917|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120918|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120919|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120920|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120921|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120922|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120923|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120924|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120925|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120926|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120927|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120928|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120929|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120930|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120931|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120932|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120933|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120934|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120935|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120936|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120937|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120938|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120939|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120940|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120941|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120942|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120943|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120944|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120945|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120946|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
121111|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
120947|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120948|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120949|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120950|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120951|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120952|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
120953|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120954|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120955|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120956|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120957|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120958|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120959|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120960|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120961|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120962|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120963|NCT01491607|O1|Outcome|BioThrax - Days 63-100 Immunogenicity|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
120964|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120965|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120966|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120967|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120968|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120969|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120970|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120971|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120972|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120973|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120974|NCT01491607|O1|Outcome|BioThrax - Day 70|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
120975|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
120976|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
120977|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
120978|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
121110|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121112|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
120979|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
120980|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
120981|NCT01491607|O5|Outcome|BioThrax- > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
120982|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
120983|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
120984|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
120985|NCT01491607|O1|Outcome|BioThrax|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
120986|NCT01491607|E1|Reported Event|ITT Population|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
120987|NCT01491490|B3|Baseline|Total|Total of all reporting groups
120988|NCT01491490|B2|Baseline|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
120989|NCT01491490|B1|Baseline|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
120990|NCT01491490|P2|Participant Flow|Placebo|Taken as 6 capsules, matched to taste and look like the active study medication.
120991|NCT01491490|P1|Participant Flow|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
120992|NCT01491490|O2|Outcome|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
120993|NCT01491490|O1|Outcome|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
120994|NCT01491490|E2|Reported Event|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
120995|NCT01491490|E1|Reported Event|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
120996|NCT01491113|B6|Baseline|Total|Total of all reporting groups
120997|NCT01491113|B5|Baseline|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
120998|NCT01491113|B4|Baseline|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
120999|NCT01491113|B3|Baseline|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
122509|NCT01484652|P2|Participant Flow|Placebo|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
121000|NCT01491113|B2|Baseline|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121001|NCT01491113|B1|Baseline|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121002|NCT01491113|P5|Participant Flow|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121003|NCT01491113|P4|Participant Flow|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121004|NCT01491113|P3|Participant Flow|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121005|NCT01491113|P2|Participant Flow|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121006|NCT01491113|P1|Participant Flow|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121007|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analysis: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121008|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121018|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121009|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121010|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121011|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121012|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121013|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121014|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121015|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121016|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121017|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
126025|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
121019|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121020|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121021|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121022|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121023|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121024|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121025|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121026|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121027|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121028|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121029|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121100|NCT01491035|B1|Baseline|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121101|NCT01491035|P8|Participant Flow|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
140587|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
121030|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121031|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121032|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121033|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121034|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121035|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121036|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121037|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121038|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121039|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121040|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121041|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121042|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121043|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121044|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121045|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121046|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121047|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121048|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121049|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121050|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121051|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121102|NCT01491035|P7|Participant Flow|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121103|NCT01491035|P6|Participant Flow|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121052|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121053|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121054|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121055|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121056|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121057|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121058|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121059|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121060|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121061|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121062|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121104|NCT01491035|P5|Participant Flow|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121105|NCT01491035|P4|Participant Flow|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
141227|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
121063|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121064|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121065|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121066|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121067|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121068|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121069|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121070|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121071|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121106|NCT01491035|P3|Participant Flow|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121107|NCT01491035|P2|Participant Flow|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121072|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121073|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121074|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121075|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121076|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121077|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121078|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121079|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121080|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121081|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121082|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121108|NCT01491035|P1|Participant Flow|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121109|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
141228|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
121083|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121084|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121085|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121086|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121087|NCT01491113|E5|Reported Event|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
121088|NCT01491113|E4|Reported Event|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
121089|NCT01491113|E3|Reported Event|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
121090|NCT01491113|E2|Reported Event|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
121091|NCT01491113|E1|Reported Event|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
121092|NCT01491035|B9|Baseline|Total|Total of all reporting groups
121093|NCT01491035|B8|Baseline|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121094|NCT01491035|B7|Baseline|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121095|NCT01491035|B6|Baseline|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121096|NCT01491035|B5|Baseline|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121097|NCT01491035|B4|Baseline|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121098|NCT01491035|B3|Baseline|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121099|NCT01491035|B2|Baseline|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121113|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121114|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121115|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121116|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121117|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121118|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121119|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121120|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121121|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121122|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121123|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121124|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121125|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121126|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121127|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121128|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121129|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121130|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121131|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121132|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121133|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121134|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121135|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121136|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121137|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121138|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121139|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121140|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121141|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121142|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121143|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121144|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121145|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121146|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121147|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121148|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121149|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121150|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121151|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121152|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121153|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121154|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121155|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121156|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
141229|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
121157|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121158|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121159|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121160|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121161|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121162|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121163|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121164|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121165|NCT01491035|E8|Reported Event|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121166|NCT01491035|E7|Reported Event|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121167|NCT01491035|E6|Reported Event|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121168|NCT01491035|E5|Reported Event|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121169|NCT01491035|E4|Reported Event|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
121170|NCT01491035|E3|Reported Event|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
121171|NCT01491035|E2|Reported Event|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
121172|NCT01491035|E1|Reported Event|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
121173|NCT01490931|B1|Baseline|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121174|NCT01490931|P1|Participant Flow|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121175|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121176|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121177|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121178|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121179|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121180|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121181|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121182|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121183|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121184|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121185|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121186|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121187|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
121188|NCT01490931|E1|Reported Event|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
141230|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
121189|NCT01490866|B1|Baseline|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
121190|NCT01490866|P1|Participant Flow|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
121191|NCT01490866|O2|Outcome|Axitinib|All patients who received at least one dose of axitinib
121192|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab|All patients who received at least one dose of FOLFOX/bevacizumab
121193|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
121194|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
121195|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
121196|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
121197|NCT01490866|E1|Reported Event|FOLFOX/Bevacizumab and Axitinib|
121198|NCT01490840|B3|Baseline|Total|Total of all reporting groups
121199|NCT01490840|B2|Baseline|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121200|NCT01490840|B1|Baseline|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121201|NCT01490840|P2|Participant Flow|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
126026|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
121202|NCT01490840|P1|Participant Flow|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121203|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121204|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121205|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121206|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121207|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121208|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121209|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121231|NCT01490294|P1|Participant Flow|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121210|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121211|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121212|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121213|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121214|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121215|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121216|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121217|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121232|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141231|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
121218|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121219|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121220|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121221|NCT01490840|E2|Reported Event|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
121222|NCT01490840|E1|Reported Event|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
121223|NCT01490294|B5|Baseline|Total|Total of all reporting groups
121224|NCT01490294|B4|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121225|NCT01490294|B3|Baseline|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121226|NCT01490294|B2|Baseline|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121227|NCT01490294|B1|Baseline|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121228|NCT01490294|P4|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121229|NCT01490294|P3|Participant Flow|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121230|NCT01490294|P2|Participant Flow|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121479|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
122510|NCT01484652|P1|Participant Flow|COV795|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
121233|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121234|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121235|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121236|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121237|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121238|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121239|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121240|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121241|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121242|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121243|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121244|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121245|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121246|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121247|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121248|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121249|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121250|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121251|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121252|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
122511|NCT01484652|O2|Outcome|Placebo|2 tablets taken every 12 hours
121253|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121254|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121255|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121256|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121257|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121258|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121259|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121260|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121261|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121262|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121263|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121264|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121265|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121266|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121267|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121268|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121269|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121270|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121271|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121272|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
122512|NCT01484652|O1|Outcome|COV795|2 tablets taken every 12 hours
121273|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121274|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121275|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121276|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121277|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121278|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121279|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121280|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121281|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121282|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121283|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121284|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121285|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121286|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121287|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121288|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121289|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121290|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121291|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121292|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141232|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
121293|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121294|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121295|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121296|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121297|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121298|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121299|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121300|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121301|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121302|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121303|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121304|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121305|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121306|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121307|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121308|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121309|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121310|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121311|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121312|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141233|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
121313|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121314|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121315|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121316|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121317|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121318|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121319|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121320|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121321|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121322|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121323|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121324|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121325|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121326|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121327|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121328|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121329|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121330|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121331|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121332|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141234|NCT01402115|E2|Reported Event|Placebo|Placebo 15mg for 12 weeks
121333|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121334|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121335|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121336|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121337|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121338|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121339|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121340|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121341|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121342|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121343|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121344|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121345|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121346|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121347|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121348|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121349|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121350|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121351|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121352|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141235|NCT01402115|E1|Reported Event|Polycan|Polycan 150mg for 12 weeks
121353|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121354|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121355|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121356|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121357|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121358|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121359|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121360|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121361|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121362|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121363|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121364|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121365|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121366|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121367|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121368|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121369|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121370|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121371|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121372|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141236|NCT01402102|B3|Baseline|Total|Total of all reporting groups
121373|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121374|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121375|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121376|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121377|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121378|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121379|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121380|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121381|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121382|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121383|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121384|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121385|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121386|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121387|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121388|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121389|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121390|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121391|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121392|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141503|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
121393|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121394|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121395|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121396|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121397|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121398|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121399|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121400|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121401|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121402|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121403|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121404|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121405|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121406|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121407|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121408|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121409|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121410|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121411|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121412|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141504|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
121413|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121414|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121415|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121416|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121417|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121418|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121419|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121420|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121421|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121422|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121423|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121424|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121425|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121426|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121427|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121428|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121429|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121430|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121431|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121432|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141505|NCT01401153|E2|Reported Event|Skipping Lunch|No lunch (water)
121433|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121434|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121435|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121436|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121437|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121438|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121439|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121440|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121441|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121442|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121443|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121444|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121445|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121446|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121447|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121448|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121449|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121450|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121451|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121452|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
141506|NCT01401153|E1|Reported Event|Having Lunch|Lunch ad libitum
121453|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121454|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121455|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121456|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121457|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121458|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121459|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121460|NCT01490294|E4|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121461|NCT01490294|E3|Reported Event|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121462|NCT01490294|E2|Reported Event|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121463|NCT01490294|E1|Reported Event|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
121464|NCT01490190|B1|Baseline|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
121465|NCT01490190|P1|Participant Flow|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
121466|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121467|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121468|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121469|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121470|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121471|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121472|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121473|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121474|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121475|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121476|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121477|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121478|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
122513|NCT01484652|E2|Reported Event|Placebo|2 tablets taken every 12 hours
121480|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121481|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121482|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121483|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
121484|NCT01490190|E1|Reported Event|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
121485|NCT01490125|B1|Baseline|All Participants|All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
121486|NCT01490125|P6|Participant Flow|Tiotropium + Placebo +QVA149|Participants were randomized to sequence tiotropium + placebo + QVA149
121487|NCT01490125|P5|Participant Flow|Tiotropium + QVA149+ Placebo|Participants were randomized to sequence tiotropium + QVA149 + placebo
121488|NCT01490125|P4|Participant Flow|Placebo+ Tiotropium + QVA149|Participants were randomized to sequence placebo + tiotropium + QVA149
121489|NCT01490125|P3|Participant Flow|Placebo + QVA149 + Tiotropium|Participants were randomized to sequence placebo + QVA149 + tiotropium
121490|NCT01490125|P2|Participant Flow|QVA149+ Tiotropium+ Placebo|Participants were randomized to sequence QVA149 + tiotropium + placebo.
121491|NCT01490125|P1|Participant Flow|QVA149+ Placebo+ Tiotropium|Participants were randomized to sequence QVA149 + placebo + tiotropium.
121492|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121493|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121494|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121495|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121496|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121497|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121498|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121499|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121500|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121501|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121502|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121503|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121504|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121505|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121506|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121507|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121508|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121509|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121510|NCT01490125|E3|Reported Event|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121511|NCT01490125|E2|Reported Event|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121512|NCT01490125|E1|Reported Event|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
121513|NCT01490086|B6|Baseline|Total|Total of all reporting groups
121514|NCT01490086|B5|Baseline|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121515|NCT01490086|B4|Baseline|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121516|NCT01490086|B3|Baseline|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121517|NCT01490086|B2|Baseline|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121518|NCT01490086|B1|Baseline|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121519|NCT01490086|P5|Participant Flow|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121520|NCT01490086|P4|Participant Flow|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121521|NCT01490086|P3|Participant Flow|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121522|NCT01490086|P2|Participant Flow|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121523|NCT01490086|P1|Participant Flow|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121524|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121525|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121526|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121527|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121528|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121529|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121530|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121531|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121532|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121533|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121534|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121535|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121536|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121537|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121538|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121539|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121540|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121541|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121542|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121543|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121544|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121545|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121546|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121547|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121548|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121549|NCT01490086|E5|Reported Event|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
121550|NCT01490086|E4|Reported Event|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
121551|NCT01490086|E3|Reported Event|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
121552|NCT01490086|E2|Reported Event|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
121553|NCT01490086|E1|Reported Event|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
121554|NCT01490060|B3|Baseline|Total|Total of all reporting groups
121555|NCT01490060|B2|Baseline|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121556|NCT01490060|B1|Baseline|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121557|NCT01490060|P4|Participant Flow|Arm B: Two Doses, Group 2|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
121558|NCT01490060|P3|Participant Flow|Arm B: Two Doses, Group 1|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
121559|NCT01490060|P2|Participant Flow|Arm A: Single Dose, Group 2|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
121560|NCT01490060|P1|Participant Flow|Arm A: Single Dose, Group 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
121561|NCT01490060|O3|Outcome|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121562|NCT01490060|O2|Outcome|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121563|NCT01490060|O1|Outcome|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
121564|NCT01490060|E3|Reported Event|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121565|NCT01490060|E2|Reported Event|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
121566|NCT01490060|E1|Reported Event|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
121567|NCT01489956|B3|Baseline|Total|Total of all reporting groups
121568|NCT01489956|B2|Baseline|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121569|NCT01489956|B1|Baseline|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121570|NCT01489956|P3|Participant Flow|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
122514|NCT01484652|E1|Reported Event|COV795|2 tablets taken every 12 hours
121571|NCT01489956|P2|Participant Flow|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121572|NCT01489956|P1|Participant Flow|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121573|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121574|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121575|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121576|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121577|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121578|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121579|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121580|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121581|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121582|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121583|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121584|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121585|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121586|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121587|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121588|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121643|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
122515|NCT01484561|B3|Baseline|Total|Total of all reporting groups
121589|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121590|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121591|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121592|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121593|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121594|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121595|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121596|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121597|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121598|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121599|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121600|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121601|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121602|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121603|NCT01489956|E3|Reported Event|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
121604|NCT01489956|E2|Reported Event|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
121605|NCT01489956|E1|Reported Event|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
121606|NCT01489891|B3|Baseline|Total|Total of all reporting groups
121607|NCT01489891|B2|Baseline|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121608|NCT01489891|B1|Baseline|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121644|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121609|NCT01489891|P2|Participant Flow|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121610|NCT01489891|P1|Participant Flow|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121611|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121612|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121613|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121614|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121615|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121616|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121617|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121618|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121619|NCT01489891|E2|Reported Event|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
121620|NCT01489891|E1|Reported Event|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
121621|NCT01489826|B10|Baseline|Total|Total of all reporting groups
121622|NCT01489826|B9|Baseline|Dexanabinol Expansion Phase|Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)
121623|NCT01489826|B8|Baseline|Dexanabinol Dose Escalation - Cohort 8|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121624|NCT01489826|B7|Baseline|Dexanabinol Dose Escalation - Cohort 7|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121625|NCT01489826|B6|Baseline|Dexanabinol Dose Escalation - Cohort 6|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121626|NCT01489826|B5|Baseline|Dexanabinol Dose Escalation - Cohort 5|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121627|NCT01489826|B4|Baseline|Dexanabinol Dose Escalation - Cohort 4|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121628|NCT01489826|B3|Baseline|Dexanabinol Dose Escalation - Cohort 3|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121629|NCT01489826|B2|Baseline|Dexanabinol Dose Escalation - Cohort 2|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121630|NCT01489826|B1|Baseline|Dexanabinol Dose Escalation - Cohort 1|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
121631|NCT01489826|P9|Participant Flow|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121632|NCT01489826|P8|Participant Flow|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121633|NCT01489826|P7|Participant Flow|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121634|NCT01489826|P6|Participant Flow|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121635|NCT01489826|P5|Participant Flow|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121636|NCT01489826|P4|Participant Flow|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121637|NCT01489826|P3|Participant Flow|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121638|NCT01489826|P2|Participant Flow|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121639|NCT01489826|P1|Participant Flow|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121640|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121641|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121642|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121877|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121645|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121646|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121647|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121648|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121649|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121650|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121651|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121652|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121653|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121654|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121655|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121656|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121657|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121658|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121659|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121660|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121661|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121662|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121663|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121664|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121665|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121666|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121667|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121668|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121669|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121670|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121671|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121672|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121673|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121674|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121675|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121676|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121677|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121678|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121679|NCT01489826|O6|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121680|NCT01489826|O5|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121681|NCT01489826|O4|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121682|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121683|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121684|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121685|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121686|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121687|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121688|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121689|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121690|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121691|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121692|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121693|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121694|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121695|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121696|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121697|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121698|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121699|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121700|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121701|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121702|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121703|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121704|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121705|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121706|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121707|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121708|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121709|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121710|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121711|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121712|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121713|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121714|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121715|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121716|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121717|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121718|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121719|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121720|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121721|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121722|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121723|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121724|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121725|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121726|NCT01489826|E9|Reported Event|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121727|NCT01489826|E8|Reported Event|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121728|NCT01489826|E7|Reported Event|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121729|NCT01489826|E6|Reported Event|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121730|NCT01489826|E5|Reported Event|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121731|NCT01489826|E4|Reported Event|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121732|NCT01489826|E3|Reported Event|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121733|NCT01489826|E2|Reported Event|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
126027|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
121734|NCT01489826|E1|Reported Event|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
121735|NCT01489670|B1|Baseline|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121736|NCT01489670|P1|Participant Flow|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121737|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121738|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121739|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121740|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121741|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121742|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121743|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121744|NCT01489670|E1|Reported Event|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
121745|NCT01489527|B3|Baseline|Total|Total of all reporting groups
121746|NCT01489527|B2|Baseline|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121747|NCT01489527|B1|Baseline|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121748|NCT01489527|P2|Participant Flow|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121749|NCT01489527|P1|Participant Flow|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121750|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121751|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121752|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121753|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121754|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121755|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121756|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121757|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121758|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121759|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121760|NCT01489527|E2|Reported Event|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
121761|NCT01489527|E1|Reported Event|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
121762|NCT01489358|B4|Baseline|Total|Total of all reporting groups
121763|NCT01489358|B3|Baseline|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121764|NCT01489358|B2|Baseline|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121765|NCT01489358|B1|Baseline|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121766|NCT01489358|P3|Participant Flow|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121767|NCT01489358|P2|Participant Flow|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121768|NCT01489358|P1|Participant Flow|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121769|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121770|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121771|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121772|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121773|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121774|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121775|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121776|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
126028|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
121777|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121778|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121779|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121780|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121781|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121782|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121783|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121784|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121785|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121786|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121787|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121788|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121789|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121790|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121791|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121792|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121793|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121794|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121795|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121796|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121797|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121798|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121799|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121800|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121801|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121802|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121803|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121804|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121805|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121806|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121807|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121808|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121809|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121810|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121811|NCT01489358|E3|Reported Event|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121878|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121812|NCT01489358|E2|Reported Event|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121813|NCT01489358|E1|Reported Event|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
121814|NCT01489254|B4|Baseline|Total|Total of all reporting groups
121815|NCT01489254|B3|Baseline|Placebo|Placebo (daily) for 9 months
121816|NCT01489254|B2|Baseline|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
121817|NCT01489254|B1|Baseline|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
121818|NCT01489254|P4|Participant Flow|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
121819|NCT01489254|P3|Participant Flow|Placebo|Placebo (daily) for 9 months
121820|NCT01489254|P2|Participant Flow|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
121821|NCT01489254|P1|Participant Flow|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
121822|NCT01489254|O3|Outcome|Placebo|Placebo (daily) for 9 months
121823|NCT01489254|O2|Outcome|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
121824|NCT01489254|O1|Outcome|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
121825|NCT01489254|E4|Reported Event|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
121826|NCT01489254|E3|Reported Event|Placebo|Placebo (daily) for 9 months, double-blind
121827|NCT01489254|E2|Reported Event|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months, double-blind
121828|NCT01489254|E1|Reported Event|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months, double-blind
121829|NCT01489189|B3|Baseline|Total|Total of all reporting groups
121830|NCT01489189|B2|Baseline|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121831|NCT01489189|B1|Baseline|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121832|NCT01489189|P2|Participant Flow|Prompt PRP|"Panretinal Photocoagulation (PRP). PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121833|NCT01489189|P1|Participant Flow|Anti-VEGF+Deferred PRP|"Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121834|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121835|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121836|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121837|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121838|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121839|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121840|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121841|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121842|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121843|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121844|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121879|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121845|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121846|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121847|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121848|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121849|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121850|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121851|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121852|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121853|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121854|NCT01489189|E3|Reported Event|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
121855|NCT01489189|E2|Reported Event|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
121856|NCT01489189|E1|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
121857|NCT01488994|B3|Baseline|Total|Total of all reporting groups
121858|NCT01488994|B2|Baseline|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to <12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121859|NCT01488994|B1|Baseline|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121860|NCT01488994|P2|Participant Flow|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121861|NCT01488994|P1|Participant Flow|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121862|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121894|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121924|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
126029|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
121863|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121864|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121865|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121866|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121867|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121868|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121869|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121870|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121871|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121872|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121873|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121874|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121875|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121876|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
126030|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
121880|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121881|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121882|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121883|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121884|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121885|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121886|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121887|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121888|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121889|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121890|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121891|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121892|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121893|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
126031|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
121895|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121896|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121897|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121898|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121899|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121900|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121901|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121902|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121903|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121904|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121905|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121906|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121907|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121908|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
126032|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
121910|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121911|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121912|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121913|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121914|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121915|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121916|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121917|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121918|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121919|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121920|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121921|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121922|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121923|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121925|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121926|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121927|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121928|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121929|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121930|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121931|NCT01488994|O2|Outcome|BAX326 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121932|NCT01488994|O1|Outcome|BAX326 < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121933|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121934|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121935|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121936|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121937|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121968|NCT01488578|O1|Outcome|With Previous Treatment|Participants with previous treatment of OAB who took tolterodine according to Japanese Package Insert.
121969|NCT01488578|O3|Outcome|>= 5 Episodes|Participants with >= 5 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
141507|NCT01401101|B3|Baseline|Total|Total of all reporting groups
121938|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121939|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
121940|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121941|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121942|NCT01488994|O1|Outcome|Overall Study Arm|No participants
121943|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121944|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121945|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
121946|NCT01488994|E1|Reported Event|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
121947|NCT01488877|B1|Baseline|Entire Study Population|All participants who were enrolled in this study.
121948|NCT01488877|P3|Participant Flow|Spironolactone Placebo|Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121949|NCT01488877|P2|Participant Flow|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121950|NCT01488877|P1|Participant Flow|PF-03882845 Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121951|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121952|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121953|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121954|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121955|NCT01488877|O1|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121956|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121957|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121958|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121959|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121960|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121961|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121962|NCT01488877|E2|Reported Event|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
121963|NCT01488877|E1|Reported Event|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
121964|NCT01488578|B1|Baseline|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121965|NCT01488578|P1|Participant Flow|Tolterodine Tartrate|Participants taking Tolterodine tartrate.
121966|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121967|NCT01488578|O2|Outcome|Without Previous Treatment|Participants without previous treatment of OAB who took tolterodine according to Japanese Package Insert.
121970|NCT01488578|O2|Outcome|3 to 4 Episodes|Participants with 3 or 4 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
121971|NCT01488578|O1|Outcome|1 to 2 Episodes|Participants with 1 or 2 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
121972|NCT01488578|O4|Outcome|>= 3 Urinations|Participants with >= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
121973|NCT01488578|O3|Outcome|2 Urinations|Participants with 2 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
121974|NCT01488578|O2|Outcome|1 Urination|Participants with 1 time urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
121975|NCT01488578|O1|Outcome|No Urination|Participants with no urination who took tolterodine according to Japanese Package Insert.
121976|NCT01488578|O2|Outcome|Without Urinary Urgency|Participants without urinary urgency who took tolterodine according to Japanese Package Insert.
121977|NCT01488578|O1|Outcome|With Urinary Urgency|Participants with urinary urgency who took tolterodine according to Japanese Package Insert.
121978|NCT01488578|O3|Outcome|Severe|Participants with severe OAB who took tolterodine according to Japanese Package Insert.
121979|NCT01488578|O2|Outcome|Moderate|Participants with moderate OAB who took tolterodine according to Japanese Package Insert.
121980|NCT01488578|O1|Outcome|Mild|Participants with mild OAB who took tolterodine according to Japanese Package Insert.
121981|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121982|NCT01488578|O2|Outcome|Without BPH|Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
121983|NCT01488578|O1|Outcome|With BPH|Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
121984|NCT01488578|O2|Outcome|>=65 Years|Participants with >= 65 years who took tolterodine according to Japanese Package Insert.
121985|NCT01488578|O1|Outcome|<65 Years|Participants with < 65 years who took tolterodine according to Japanese Package Insert.
121986|NCT01488578|O2|Outcome|Without Complications|Participants without complications who took tolterodine according to Japanese Package Insert.
121987|NCT01488578|O1|Outcome|With Complications|Participants with complications who took tolterodine according to Japanese Package Insert.
121988|NCT01488578|O2|Outcome|Female|Female participants who took tolterodine according to Japanese Package Insert.
121989|NCT01488578|O1|Outcome|Male|Male participants who took tolterodine according to Japanese Package Insert.
121990|NCT01488578|O2|Outcome|Without Non-drug Therapies|Participants without non-drug therapies who took tolterodine according to Japanese Package Insert.
121991|NCT01488578|O1|Outcome|With Non-drug Therapies|Participants with non-drug therapies who took tolterodine according to Japanese Package Insert.
121992|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121993|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121994|NCT01488578|O2|Outcome|Without Concomitant Drugs|Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.
121995|NCT01488578|O1|Outcome|With Concomitant Drugs|Participants with concomitant drugs who took tolterodine according to Japanese Package Insert.
121996|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121997|NCT01488578|E1|Reported Event|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
121998|NCT01488487|B1|Baseline|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
121999|NCT01488487|P1|Participant Flow|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122000|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122001|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122002|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122051|NCT01488188|P1|Participant Flow|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122052|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
142935|NCT01395524|E2|Reported Event|NKTR-118 25 mg|
122003|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122004|NCT01488487|E1|Reported Event|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
122005|NCT01488448|B3|Baseline|Total|Total of all reporting groups
122006|NCT01488448|B2|Baseline|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122007|NCT01488448|B1|Baseline|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122008|NCT01488448|P2|Participant Flow|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122009|NCT01488448|P1|Participant Flow|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122010|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122011|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122012|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122013|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122014|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122015|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122016|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122017|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122018|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122019|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122020|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122021|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122022|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122023|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122024|NCT01488448|O2|Outcome|Nebulized Normal Saline|"4 mL nebulized 0.9% sodium chloride every 4 hours until discharge~0.9% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
122025|NCT01488448|O1|Outcome|Nebulized Hypertonic Saline|"4mL nebulized 3% sodium chloride every 4 hours until discharge~3% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
122026|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
122027|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122028|NCT01488448|E2|Reported Event|Normal Saline|4mL nebulized 0.9% sodium chloride every 4 hours until discharge
122029|NCT01488448|E1|Reported Event|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
122030|NCT01488409|B3|Baseline|Total|Total of all reporting groups
122031|NCT01488409|B2|Baseline|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122032|NCT01488409|B1|Baseline|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122033|NCT01488409|P2|Participant Flow|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122034|NCT01488409|P1|Participant Flow|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122035|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122036|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122037|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122038|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122039|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122040|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122041|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122042|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122043|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122044|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122045|NCT01488409|E2|Reported Event|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
122046|NCT01488409|E1|Reported Event|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
122047|NCT01488188|B3|Baseline|Total|Total of all reporting groups
122048|NCT01488188|B2|Baseline|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122049|NCT01488188|B1|Baseline|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122050|NCT01488188|P2|Participant Flow|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122053|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122054|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122055|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122056|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122057|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122058|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122059|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122060|NCT01488188|E2|Reported Event|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
122061|NCT01488188|E1|Reported Event|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
122062|NCT01488097|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122063|NCT01488097|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122064|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122065|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122066|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122067|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122068|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122069|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122132|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122070|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122071|NCT01488097|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
122072|NCT01488071|B3|Baseline|Total|Total of all reporting groups
122073|NCT01488071|B2|Baseline|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122074|NCT01488071|B1|Baseline|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122075|NCT01488071|P2|Participant Flow|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122076|NCT01488071|P1|Participant Flow|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122077|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122078|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122079|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122080|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122081|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122082|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122083|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122084|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122085|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122086|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122087|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122088|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122089|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122090|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122091|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122092|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122093|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122094|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122095|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122096|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122097|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122098|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122099|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122100|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122101|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122102|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122103|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
122104|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
122105|NCT01488071|E2|Reported Event|Agomelatine|
122106|NCT01488071|E1|Reported Event|Vortioxetine|
122107|NCT01487954|B3|Baseline|Total|Total of all reporting groups
122108|NCT01487954|B2|Baseline|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122109|NCT01487954|B1|Baseline|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122110|NCT01487954|P2|Participant Flow|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122111|NCT01487954|P1|Participant Flow|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
142936|NCT01395524|E1|Reported Event|NKTR-118 12.5 mg|
122112|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122113|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122114|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122115|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122116|NCT01487954|E2|Reported Event|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122117|NCT01487954|E1|Reported Event|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
122118|NCT01487668|B3|Baseline|Total|Total of all reporting groups
122119|NCT01487668|B2|Baseline|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
122120|NCT01487668|B1|Baseline|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
122121|NCT01487668|P2|Participant Flow|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
122122|NCT01487668|P1|Participant Flow|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
122123|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages
122124|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
122125|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
122126|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
122127|NCT01487668|E2|Reported Event|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
122128|NCT01487668|E1|Reported Event|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
122129|NCT01487577|B1|Baseline|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122130|NCT01487577|P1|Participant Flow|Mycophenolate Mofetil|Pharmacokinetics-based targeting of Mycophenolate mofetil
122131|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122217|NCT01486927|E1|Reported Event|Safety Population|The Safety Population comprised all subjects treated with rVIII-SingleChain.
122133|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122134|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122135|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122136|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122137|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122138|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122139|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122140|NCT01487577|E1|Reported Event|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
122141|NCT01487525|B3|Baseline|Total|Total of all reporting groups
122142|NCT01487525|B2|Baseline|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122143|NCT01487525|B1|Baseline|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122144|NCT01487525|P2|Participant Flow|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122145|NCT01487525|P1|Participant Flow|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122146|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122147|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122148|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122149|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122150|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122151|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122152|NCT01487525|E2|Reported Event|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
122153|NCT01487525|E1|Reported Event|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
122154|NCT01487499|B1|Baseline|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122155|NCT01487499|P1|Participant Flow|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122156|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122157|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122158|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122159|NCT01487499|E1|Reported Event|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
122160|NCT01486966|B3|Baseline|Total|Total of all reporting groups
122161|NCT01486966|B2|Baseline|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122218|NCT01486615|B5|Baseline|Total|Total of all reporting groups
122162|NCT01486966|B1|Baseline|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122163|NCT01486966|P2|Participant Flow|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122164|NCT01486966|P1|Participant Flow|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122165|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122166|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122167|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122168|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122169|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122170|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122171|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122172|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122173|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122174|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122175|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122176|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122177|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122178|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122179|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122180|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122181|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122182|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122183|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122184|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122185|NCT01486966|E2|Reported Event|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122186|NCT01486966|E1|Reported Event|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
122187|NCT01486927|B1|Baseline|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
122188|NCT01486927|P1|Participant Flow|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
122189|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122190|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122191|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122192|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122193|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122194|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122195|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122196|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
122197|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least one dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
122219|NCT01486615|B4|Baseline|Placebo|premedication 1-2 hr prior to anesthesia
122220|NCT01486615|B3|Baseline|Alprazolam|premedication 1-2 hr prior to anesthesia
122198|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
122199|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
122200|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
122201|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
122202|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122203|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122204|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122205|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122206|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122207|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122208|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122209|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
122210|NCT01486927|O1|Outcome|rVIII-SingleChain Surgical|The rVIII-SingleChain Surgical group included all subjects enrolled in the surgical sub-study who received at least 1 dose of rVIII-SingleChain during the surgical sub-study. There were 13 subjects in the rVIII-SingleChain Surgical group.
122211|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
122212|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
122213|NCT01486927|O1|Outcome|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
122214|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
122215|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
122216|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
122225|NCT01486615|P2|Participant Flow|Melatonin and Alprazolam|Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia
122226|NCT01486615|P1|Participant Flow|Melatonin|Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia
122227|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122228|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122229|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122230|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122231|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122232|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122233|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122234|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122235|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122236|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122237|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122238|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122239|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122240|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122241|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122242|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122243|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122244|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122245|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122246|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122247|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122248|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122249|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122250|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122251|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122252|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122253|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122254|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122255|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
122256|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
122257|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
122258|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
122259|NCT01486615|E4|Reported Event|Placebo|premedication 1-2 hr prior to anesthesia
122260|NCT01486615|E3|Reported Event|Alprazolam|premedication 1-2 hr prior to anesthesia
122261|NCT01486615|E2|Reported Event|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
122262|NCT01486615|E1|Reported Event|Melatonin|premedication 1-2 hour prior to anesthesia
122263|NCT01486446|B3|Baseline|Total|Total of all reporting groups
122264|NCT01486446|B2|Baseline|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122265|NCT01486446|B1|Baseline|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122266|NCT01486446|P2|Participant Flow|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122267|NCT01486446|P1|Participant Flow|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122268|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122269|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122270|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122271|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122272|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122273|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122274|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122275|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122276|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122277|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122278|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122279|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122655|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122280|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122281|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122282|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122283|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122284|NCT01486446|E2|Reported Event|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
122285|NCT01486446|E1|Reported Event|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
122286|NCT01486238|B3|Baseline|Total|Total of all reporting groups
122287|NCT01486238|B2|Baseline|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
122288|NCT01486238|B1|Baseline|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
122289|NCT01486238|P2|Participant Flow|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
122290|NCT01486238|P1|Participant Flow|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
122291|NCT01486238|O2|Outcome|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
122292|NCT01486238|O1|Outcome|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
122293|NCT01486238|E2|Reported Event|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
122294|NCT01486238|E1|Reported Event|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
122295|NCT01486043|B1|Baseline|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
122296|NCT01486043|P1|Participant Flow|Metformin and Insulin Therapy|"For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study.~For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011."
122297|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
122298|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
122299|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
122300|NCT01486043|E1|Reported Event|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
122301|NCT01485991|B3|Baseline|Total|Total of all reporting groups
122302|NCT01485991|B2|Baseline|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122303|NCT01485991|B1|Baseline|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122304|NCT01485991|P2|Participant Flow|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122305|NCT01485991|P1|Participant Flow|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122306|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122307|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122308|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122309|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122656|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
142937|NCT01395394|B4|Baseline|Total|Total of all reporting groups
122310|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122311|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122312|NCT01485991|E2|Reported Event|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
122313|NCT01485991|E1|Reported Event|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
122314|NCT01485887|B1|Baseline|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122315|NCT01485887|P1|Participant Flow|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122316|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122317|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122318|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122319|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122320|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
126033|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
122321|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122322|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122323|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122324|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122325|NCT01485887|E1|Reported Event|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
122326|NCT01485640|B1|Baseline|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
122327|NCT01485640|P1|Participant Flow|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
122328|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
122329|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
122330|NCT01485640|E1|Reported Event|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
122331|NCT01485536|B1|Baseline|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
122332|NCT01485536|P1|Participant Flow|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
122333|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
122334|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
122335|NCT01485536|E1|Reported Event|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
122336|NCT01485380|B1|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
122337|NCT01485380|P1|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
122657|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122338|NCT01485380|O1|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli."
122339|NCT01485380|E1|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
122340|NCT01485172|B7|Baseline|Total|Total of all reporting groups
122341|NCT01485172|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122342|NCT01485172|B5|Baseline|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122343|NCT01485172|B4|Baseline|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122344|NCT01485172|B3|Baseline|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122345|NCT01485172|B2|Baseline|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122346|NCT01485172|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122347|NCT01485172|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122348|NCT01485172|P5|Participant Flow|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122349|NCT01485172|P4|Participant Flow|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122350|NCT01485172|P3|Participant Flow|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122351|NCT01485172|P2|Participant Flow|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122352|NCT01485172|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122353|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
143625|NCT01391507|B5|Baseline|Total|Total of all reporting groups
122354|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122355|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122356|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122357|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122358|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122359|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122360|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122361|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122362|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122363|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122364|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122365|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122366|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122367|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122368|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122369|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122370|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122371|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122372|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122373|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122374|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122375|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122376|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122377|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122378|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122379|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122380|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122381|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122382|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122383|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122384|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122385|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122810|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122386|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122387|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122388|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122389|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122390|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122391|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122392|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122393|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122394|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122395|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122396|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122397|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122398|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122399|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122400|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122401|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122658|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122402|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122403|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122404|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122405|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122406|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122407|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122408|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122409|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122410|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122411|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122412|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122413|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122414|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122415|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122416|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122417|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122418|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122419|NCT01485172|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122420|NCT01485172|E5|Reported Event|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122421|NCT01485172|E4|Reported Event|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122422|NCT01485172|E3|Reported Event|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122423|NCT01485172|E2|Reported Event|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
122424|NCT01485172|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
122425|NCT01485094|B4|Baseline|Total|Total of all reporting groups
122426|NCT01485094|B3|Baseline|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122427|NCT01485094|B2|Baseline|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
122428|NCT01485094|B1|Baseline|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122429|NCT01485094|P3|Participant Flow|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122430|NCT01485094|P2|Participant Flow|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
122431|NCT01485094|P1|Participant Flow|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo: Matching Placebo capsules to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122432|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122433|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122434|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122435|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122436|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122437|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122438|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122439|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122440|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122441|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122442|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122443|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122444|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122445|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122446|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122447|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122448|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122449|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122450|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122451|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122452|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122453|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122454|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122455|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122456|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122457|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122458|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122459|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122460|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122461|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122462|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122463|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122464|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122465|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122466|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122467|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122468|NCT01485094|E3|Reported Event|Pregabalin|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Pregabalin: Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
122469|NCT01485094|E2|Reported Event|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
122470|NCT01485094|E1|Reported Event|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Matching Placebo: Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
122516|NCT01484561|B2|Baseline|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122471|NCT01484977|B1|Baseline|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
122472|NCT01484977|P1|Participant Flow|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
122473|NCT01484977|O1|Outcome|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
122474|NCT01484977|E1|Reported Event|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
122475|NCT01484951|B1|Baseline|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
122476|NCT01484951|P1|Participant Flow|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
122477|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
122478|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
122479|NCT01484951|E1|Reported Event|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
122480|NCT01484938|B1|Baseline|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
122481|NCT01484938|P1|Participant Flow|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
122482|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
122483|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
122484|NCT01484938|E1|Reported Event|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
122485|NCT01484912|B3|Baseline|Total|Total of all reporting groups
122486|NCT01484912|B2|Baseline|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122487|NCT01484912|B1|Baseline|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122488|NCT01484912|P2|Participant Flow|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122489|NCT01484912|P1|Participant Flow|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122490|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122491|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122492|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122493|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122494|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122495|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122496|NCT01484912|E2|Reported Event|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122497|NCT01484912|E1|Reported Event|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
122498|NCT01484873|B1|Baseline|Exenatide|exenatide 10 mcg twice daily
122499|NCT01484873|P1|Participant Flow|Exenatide|exenatide 10 mcg twice daily
122500|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
122501|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
122502|NCT01484873|O1|Outcome|Exenatide|Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
122503|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
122504|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
122505|NCT01484873|E1|Reported Event|Exenatide|exenatide 10 mcg twice daily
122506|NCT01484652|B3|Baseline|Total|Total of all reporting groups
122517|NCT01484561|B1|Baseline|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122518|NCT01484561|P2|Participant Flow|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122519|NCT01484561|P1|Participant Flow|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122520|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122521|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122522|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122523|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122524|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122525|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122526|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122527|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122528|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122529|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122530|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122531|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122532|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122533|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122534|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122535|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122536|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122537|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122538|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122539|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122540|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122541|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122542|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122647|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122543|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122544|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122545|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122546|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122547|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122548|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122549|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122550|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122551|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122552|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122553|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122554|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122555|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122556|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122557|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122558|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122559|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122560|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122561|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122562|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122563|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122564|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122565|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122566|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122567|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122568|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122648|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122569|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122570|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122571|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122572|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122573|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122574|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122575|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122576|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122577|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122578|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122579|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122580|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122581|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122582|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122583|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122584|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122585|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122586|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122587|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122588|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122589|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122590|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122591|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122592|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122593|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122594|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122649|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122595|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122596|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122597|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122598|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122599|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122600|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122601|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122602|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122603|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122604|NCT01484561|E2|Reported Event|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
122605|NCT01484561|E1|Reported Event|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
122606|NCT01484314|B1|Baseline|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
122607|NCT01484314|P1|Participant Flow|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
122608|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
122609|NCT01484314|E1|Reported Event|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
122610|NCT01484197|B1|Baseline|All Participants|All participants randomized to one of four treatment sequences.
122611|NCT01484197|P4|Participant Flow|Sequence 4|Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
122612|NCT01484197|P3|Participant Flow|Sequence 3|Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
122650|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122651|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122652|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122653|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122654|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122613|NCT01484197|P2|Participant Flow|Sequence 2|Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
122614|NCT01484197|P1|Participant Flow|Sequence 1|Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
122615|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122616|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122617|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122618|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122619|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122620|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122621|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122622|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122623|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122624|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122625|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122626|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122627|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122628|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122629|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122630|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122631|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122632|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122633|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122634|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122635|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122636|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122637|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122638|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122639|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122640|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122641|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122642|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122643|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122644|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122645|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122646|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122659|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122660|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122661|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122662|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122663|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122664|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122665|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122666|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122667|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122668|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122669|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122670|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122671|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122672|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122673|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122674|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122675|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122676|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122677|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122678|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122679|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122680|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122681|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122682|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122683|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122684|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122685|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122686|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122687|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122688|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122689|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122690|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122691|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122692|NCT01484197|E4|Reported Event|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
122693|NCT01484197|E3|Reported Event|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
122694|NCT01484197|E2|Reported Event|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
122695|NCT01484197|E1|Reported Event|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
122696|NCT01484132|B1|Baseline|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122697|NCT01484132|P1|Participant Flow|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122698|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122699|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122700|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
126034|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
122701|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122702|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122703|NCT01484132|E1|Reported Event|Composite|Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
122704|NCT01484054|B1|Baseline|All Subjects|All enrolled subjects who received study lenses.
122705|NCT01484054|P2|Participant Flow|EADE/EAPVPDE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
122706|NCT01484054|P1|Participant Flow|EAPVPDE/EADE|etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
122707|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
122708|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
122709|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
122710|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
122711|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
122712|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens.
122713|NCT01484054|E2|Reported Event|EADE|etafilcon a existing, daily disposable contact lens.
122714|NCT01484054|E1|Reported Event|EAPVPDE|etafilcon A material incorporating PVP in the blister packaging solution.
122715|NCT01484041|B1|Baseline|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122716|NCT01484041|P1|Participant Flow|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122717|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122718|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122719|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122720|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122721|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122722|NCT01484041|E1|Reported Event|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
122723|NCT01484028|B1|Baseline|All Subjects|All randomized subjects who worn at least one pair of study lenses.
122724|NCT01484028|P4|Participant Flow|EALE/1DM|etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
122725|NCT01484028|P3|Participant Flow|EADE/1DM|etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
122726|NCT01484028|P2|Participant Flow|1DM/EALE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
122727|NCT01484028|P1|Participant Flow|1DM/EADE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
122728|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia, two were discontinued between the first and second periods.
122729|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
122730|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia.
122731|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
122732|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lens to correct myopia.
122733|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
122734|NCT01484028|E2|Reported Event|Etafilcon A Control Lenses|A marketed daily disposable contact lens to correct myopia.
122735|NCT01484028|E1|Reported Event|Etafilcon A With PVP for Dark/Light Eyes|A daily disposable contact lens to correct myopia.
122736|NCT01483937|B3|Baseline|Total|Total of all reporting groups
122737|NCT01483937|B2|Baseline|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122738|NCT01483937|B1|Baseline|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122739|NCT01483937|P2|Participant Flow|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122740|NCT01483937|P1|Participant Flow|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122741|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
122742|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
122743|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
122744|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
122745|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
122746|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received usual care physical therapy from vestibular and balance specialists."
122747|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
122748|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
122749|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122750|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122751|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122752|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122753|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122754|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122755|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122756|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122757|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122758|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122759|NCT01483937|E2|Reported Event|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
122760|NCT01483937|E1|Reported Event|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
122761|NCT01483924|B6|Baseline|Total|Total of all reporting groups
122762|NCT01483924|B5|Baseline|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122763|NCT01483924|B4|Baseline|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122764|NCT01483924|B3|Baseline|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122765|NCT01483924|B2|Baseline|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122766|NCT01483924|B1|Baseline|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122767|NCT01483924|P5|Participant Flow|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122768|NCT01483924|P4|Participant Flow|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122769|NCT01483924|P3|Participant Flow|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122770|NCT01483924|P2|Participant Flow|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122771|NCT01483924|P1|Participant Flow|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122772|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122773|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122774|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122775|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122776|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122777|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122778|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122779|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122780|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122781|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122782|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122783|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122784|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122785|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122786|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122787|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
122788|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122789|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
122790|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
122791|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122792|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122793|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122794|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122795|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122796|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122797|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122798|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122799|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122800|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122801|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122802|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122803|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122804|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122805|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122806|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
122807|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122808|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
122809|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122811|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
122812|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122813|NCT01483924|E5|Reported Event|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
122814|NCT01483924|E4|Reported Event|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
122815|NCT01483924|E3|Reported Event|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
122816|NCT01483924|E2|Reported Event|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
122817|NCT01483924|E1|Reported Event|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
122818|NCT01483820|B1|Baseline|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122819|NCT01483820|P1|Participant Flow|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122820|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122821|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122822|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122823|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122824|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122825|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122826|NCT01483820|E1|Reported Event|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
122827|NCT01483651|B1|Baseline|All Study Participants|Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
122828|NCT01483651|P6|Participant Flow|High, Medium and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
122829|NCT01483651|P5|Participant Flow|High, Low and Medium Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
122830|NCT01483651|P4|Participant Flow|Medium, High and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
122831|NCT01483651|P3|Participant Flow|Medium, Low and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
122832|NCT01483651|P2|Participant Flow|Low, High and Medium Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
122833|NCT01483651|P1|Participant Flow|Low, Medium and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
122834|NCT01483651|O3|Outcome|High Insulin Infusion Rate|Regular insulin infused at highest level with glucagon administration.
122835|NCT01483651|O2|Outcome|Medium Insulin Infusion Rate|Regular insulin infused at medium level with glucagon administration.
122836|NCT01483651|O1|Outcome|Low Insulin Infusion Rate|Regular insulin infused at lowest level of glucagon administration.
122837|NCT01483651|E3|Reported Event|High Insulin Infusion|regular insulin infused at highest level with glucagon administration.
122838|NCT01483651|E2|Reported Event|Medium Insulin Infusion|Regular insulin infused at medium level with glucagon administration.
122839|NCT01483651|E1|Reported Event|Low Insulin Infusion|Regular insulin infused at lowest level with glucagon administration.
122840|NCT01483625|B3|Baseline|Total|Total of all reporting groups
122841|NCT01483625|B2|Baseline|Tiotropium 18mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122842|NCT01483625|B1|Baseline|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122843|NCT01483625|P2|Participant Flow|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122844|NCT01483625|P1|Participant Flow|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122845|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122846|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122847|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122848|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122849|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122850|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122851|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122852|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122853|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122854|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122855|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122856|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122857|NCT01483625|E2|Reported Event|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
122858|NCT01483625|E1|Reported Event|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
122859|NCT01483378|B1|Baseline|Survey Participants|
122860|NCT01483378|P2|Participant Flow|Patients Who Declined the Herpes Zoster Vaccine|These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
122861|NCT01483378|P1|Participant Flow|Patients Who Received the Herpes Zoster Vaccine|These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
122862|NCT01483378|O2|Outcome|Patients Who Declined the Herpes Zoster Vaccine|Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
122863|NCT01483378|O1|Outcome|Patients Who Received the Herpes Zoster Vaccine|Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
122864|NCT01483378|E2|Reported Event|Subjects Who Declined the Herpes Zoster Vaccine|
122865|NCT01483378|E1|Reported Event|Subjects Who Received the Herpes Zoster Vaccine|
122866|NCT01483352|B1|Baseline|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122867|NCT01483352|P1|Participant Flow|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122868|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122869|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122870|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122871|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122872|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122873|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122874|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122875|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122876|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122877|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122878|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122879|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122880|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122881|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122882|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122883|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122884|NCT01483352|E1|Reported Event|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
122885|NCT01483209|B1|Baseline|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
123441|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
122886|NCT01483209|P1|Participant Flow|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
122887|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
122888|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
122889|NCT01483209|E1|Reported Event|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
122890|NCT01482910|B3|Baseline|Total|Total of all reporting groups
122891|NCT01482910|B2|Baseline|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
122892|NCT01482910|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
122893|NCT01482910|P2|Participant Flow|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
122894|NCT01482910|P1|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
122895|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
122896|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
122897|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
122898|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
122899|NCT01482910|E4|Reported Event|PDT Then Aflibercept Injection, From Week 28 to Week 52|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
122900|NCT01482910|E3|Reported Event|Aflibercept Injection, From Week 28 to Week 52|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
122901|NCT01482910|E2|Reported Event|PDT Treatments, up to Week 28|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
122902|NCT01482910|E1|Reported Event|Aflibercept Injection, up to Week 28|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
122903|NCT01482884|B3|Baseline|Total|Total of all reporting groups
122904|NCT01482884|B2|Baseline|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122905|NCT01482884|B1|Baseline|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122906|NCT01482884|P2|Participant Flow|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122907|NCT01482884|P1|Participant Flow|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122908|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122909|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122910|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122911|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122912|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122913|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122914|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122915|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122916|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
126035|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
122917|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122918|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122919|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122920|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122921|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122922|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122923|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122924|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122925|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122926|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122927|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122928|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122929|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122930|NCT01482884|E2|Reported Event|Tralokinumab 300 mg|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
122931|NCT01482884|E1|Reported Event|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
122932|NCT01482819|B1|Baseline|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
122933|NCT01482819|P1|Participant Flow|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
122934|NCT01482819|O5|Outcome|Polymacon|test article
122935|NCT01482819|O4|Outcome|Lotrafilcon A|test article
122936|NCT01482819|O3|Outcome|Galyfilcon A|test article
122937|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
122938|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
122939|NCT01482819|O5|Outcome|Polymacon|test article
122940|NCT01482819|O4|Outcome|Lotrafilcon A|test article
122941|NCT01482819|O3|Outcome|Galyfilcon A|test article
122942|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
122943|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
122944|NCT01482819|O5|Outcome|Polymacon|test article
122945|NCT01482819|O4|Outcome|Lotrafilcon A|test article
122946|NCT01482819|O3|Outcome|Galyfilcon A|test article
122947|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
122948|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
122949|NCT01482819|E1|Reported Event|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
122950|NCT01482767|B3|Baseline|Total|Total of all reporting groups
122951|NCT01482767|B2|Baseline|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122952|NCT01482767|B1|Baseline|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122953|NCT01482767|P2|Participant Flow|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122954|NCT01482767|P1|Participant Flow|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122955|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
123003|NCT01482091|B1|Baseline|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
144555|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
122956|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122957|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122958|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122959|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122960|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122961|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122962|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122963|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122964|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122965|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122966|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122967|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122968|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122969|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122970|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122971|NCT01482767|E2|Reported Event|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
123004|NCT01482091|P2|Participant Flow|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123442|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
122972|NCT01482767|E1|Reported Event|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
122973|NCT01482429|B3|Baseline|Total|Total of all reporting groups
122974|NCT01482429|B2|Baseline|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
122975|NCT01482429|B1|Baseline|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
122976|NCT01482429|P2|Participant Flow|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
122977|NCT01482429|P1|Participant Flow|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
122978|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
122979|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
122980|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
122981|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
122982|NCT01482429|E2|Reported Event|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
122983|NCT01482429|E1|Reported Event|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
122984|NCT01482325|B1|Baseline|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor"
122985|NCT01482325|P1|Participant Flow|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
122986|NCT01482325|O1|Outcome|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
122987|NCT01482325|E1|Reported Event|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor~At Site #001 – St. Joseph’s Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported.~At Site #002 – Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported."
122988|NCT01482312|B1|Baseline|Overall|This reporting group includes all enrolled participants.
122989|NCT01482312|P3|Participant Flow|Glasses / Lotrafilcon A / Comfilcon A|Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
122990|NCT01482312|P2|Participant Flow|Comfilcon A / Glasses / Lotrafilcon A|Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
122991|NCT01482312|P1|Participant Flow|Lotrafilcon A / Comfilcon A / Glasses|Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
122992|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
122993|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
122994|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
122995|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
122996|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
122997|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
122998|NCT01482312|E3|Reported Event|Glasses|Glasses per habitual prescription
122999|NCT01482312|E2|Reported Event|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
123000|NCT01482312|E1|Reported Event|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
123001|NCT01482091|B3|Baseline|Total|Total of all reporting groups
123002|NCT01482091|B2|Baseline|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123005|NCT01482091|P1|Participant Flow|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123006|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123007|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123008|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123009|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123010|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123011|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123012|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123013|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123014|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123015|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123016|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123017|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123018|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123019|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123020|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123021|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123022|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123023|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123024|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123025|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123026|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123027|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123028|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123029|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123030|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123031|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123032|NCT01482091|E2|Reported Event|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
123033|NCT01482091|E1|Reported Event|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
123034|NCT01482065|B3|Baseline|Total|Total of all reporting groups
123035|NCT01482065|B2|Baseline|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123036|NCT01482065|B1|Baseline|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123037|NCT01482065|P2|Participant Flow|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123038|NCT01482065|P1|Participant Flow|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123039|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123040|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123041|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123102|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123103|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
126036|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
123042|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123043|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123044|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123045|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123046|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123047|NCT01482065|E2|Reported Event|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
123048|NCT01482065|E1|Reported Event|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
123049|NCT01481935|B3|Baseline|Total|Total of all reporting groups
123050|NCT01481935|B2|Baseline|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123051|NCT01481935|B1|Baseline|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123104|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123052|NCT01481935|P2|Participant Flow|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123053|NCT01481935|P1|Participant Flow|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123054|NCT01481935|O2|Outcome|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123055|NCT01481935|O1|Outcome|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123056|NCT01481935|E2|Reported Event|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123057|NCT01481935|E1|Reported Event|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
123058|NCT01481896|B1|Baseline|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
123059|NCT01481896|P1|Participant Flow|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
123060|NCT01481896|O1|Outcome|Patients Satisfied With Outcome of Hip Replacement|"Patient satisfaction was evaluated by asking the question, Are you satisfied with the results of your hip operation? on a questionnaire. Patients could respond Yes or No by filling in the appropriated bubble on the questionnaire."
123061|NCT01481896|O1|Outcome|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
123062|NCT01481896|O2|Outcome|Cup Stability|Based on the most recent follow-up x-ray, the fixation of the cup component implanted in a patient's pelvis was graded as bone ingrown, fibrous stable or loose. A cup was considered fibrous stable if there was a continuous radiolucent line along the interface between the cup and the patient's pelvic bone. A cup was considered loose if it had migrated more than 2 mm or its orientation had changed by at least 5 degrees on the follow-up x-ray compared to the immediate post-operative x-ray. A cup that did not meet the criteria for fibrous stable or loose was considered bone ingrown.
123063|NCT01481896|O1|Outcome|Stem Stability|"Based on the most recent follow-up x-ray, the fixation of the stem component implanted in a patient's femur was graded as bone ingrown, fibrous stable or loose using the criteria defined by Engh, Massin and Suthers in their article titled Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components published in the August 1990 edition of Clinical Orthopaedics and Related Research on pages 107 to 128."
123064|NCT01481896|O2|Outcome|Hips With CT Scans Analyzed for Pelvic Osteolysis|Digital Computed Tomography (CT) scans taken more than 5 years after a patient's hip replacement were used to evaluate pelvic bone loss (osteolysis). Regions of bone loss were traced on CT slices to determine the volume and location of each osteolytic defect using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). For the purposes of reporting, the total number of hips with any evidence of pelvic osteolysis on CT is indicated.
123065|NCT01481896|O1|Outcome|Hips With Radiographs Analyzed for Femoral Osteolysis|Serial x-rays for each hip replacement were analyzed by a single experienced reviewer to identify regions where bone had been lost in the femur. Expansile (ballooned-out) regions of bone loss identified on follow-up x-rays taken at least 4.75 years after their surgery that were not apparent on the immediate post-operative x-ray were considered to be osteolysis. For the purposes of reporting, the total number of hips with any evidence of femoral osteolysis on x-ray is indicated.
123066|NCT01481896|O1|Outcome|Hips With Harris Hip Scores|The Harris Hip Score is an outcome measure used for hip replacements that ranges from 0 (worst) to 100 (best). The score consists of a series of questions related to hip pain, function and range of motion that accumulate a different number of points depending on the response choices. At the time of their follow-up visits, patients completed a standardized questionnaire that included components of the Harris Hip Score and the physician completed a standardized evaluation which included range of motion assessment.
144556|NCT01388816|O3|Outcome|DRL-17822 300 mg|Once daily after breakfast
123067|NCT01481896|O2|Outcome|Cup Anteversion Angle|The Cup Anteversion Angle quantifies the front-to-back rotation of the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the circular face of the cup projects onto the x-ray as an ellipse. The ratio of the major axis of the ellipse to the minor axis can be used to calculate the anteversion. A cup rotated anteriorly has positive anteversion. A cup rotated posteriorly has negative anteversion. For this study, the cup Anteversion Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL). Taken together, the abduction and anteversion angle quantify the three-dimensional orientation of the cup.
123068|NCT01481896|O1|Outcome|Cup Abduction Angle|The Cup Abduction Angle quantifies the amount of tilt associated with the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the angle between the face of the cup and a horizontal line defines the Cup Abduction Angle. The line defining the face of the cup is drawn through the uppermost and lowest edges of the cup's projection on the x-ray. For this study, the Cup Abduction Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL).
123069|NCT01481896|O2|Outcome|Patients With Serum Chromium Levels|Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater.
123070|NCT01481896|O1|Outcome|Patients With Serum Cobalt Levels|Patients were recommended to have blood drawn for evaluation of serum cobalt levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. Among all the labs that performed metal level assessments, the cobalt detection limit varied from 0.5 to 1.0 microgram per liter. Patients with undetectable cobalt levels were assigned a value of zero. A patient's cobalt level was considered high if it was 7 micrograms per liter or greater.
123071|NCT01481896|E1|Reported Event|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
123072|NCT01481740|B3|Baseline|Total|Total of all reporting groups
123073|NCT01481740|B2|Baseline|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123074|NCT01481740|B1|Baseline|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123075|NCT01481740|P2|Participant Flow|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123076|NCT01481740|P1|Participant Flow|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123077|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123078|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123079|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123080|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123081|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123082|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123083|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123084|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123085|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123086|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123087|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123088|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123089|NCT01481740|E2|Reported Event|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
123090|NCT01481740|E1|Reported Event|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
123091|NCT01481558|B3|Baseline|Total|Total of all reporting groups
123092|NCT01481558|B2|Baseline|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
123093|NCT01481558|B1|Baseline|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
123094|NCT01481558|P2|Participant Flow|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
123095|NCT01481558|P1|Participant Flow|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
123096|NCT01481558|O2|Outcome|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
123097|NCT01481558|O1|Outcome|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
123098|NCT01481558|E2|Reported Event|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
123099|NCT01481558|E1|Reported Event|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
123100|NCT01481376|B1|Baseline|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123101|NCT01481376|P1|Participant Flow|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123443|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123105|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123106|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123107|NCT01481376|E1|Reported Event|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
123108|NCT01481324|B4|Baseline|Total|Total of all reporting groups
123109|NCT01481324|B3|Baseline|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
123110|NCT01481324|B2|Baseline|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123111|NCT01481324|B1|Baseline|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123112|NCT01481324|P3|Participant Flow|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
123113|NCT01481324|P2|Participant Flow|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123114|NCT01481324|P1|Participant Flow|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123115|NCT01481324|O3|Outcome|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
123116|NCT01481324|O2|Outcome|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123117|NCT01481324|O1|Outcome|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123118|NCT01481324|E3|Reported Event|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
123119|NCT01481324|E2|Reported Event|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123120|NCT01481324|E1|Reported Event|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
123121|NCT01481116|B4|Baseline|Total|Total of all reporting groups
123122|NCT01481116|B3|Baseline|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123123|NCT01481116|B2|Baseline|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123124|NCT01481116|B1|Baseline|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123125|NCT01481116|P3|Participant Flow|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123126|NCT01481116|P2|Participant Flow|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123127|NCT01481116|P1|Participant Flow|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123128|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123129|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123130|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123131|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123132|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123133|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123444|NCT01479595|E2|Reported Event|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123134|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123135|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123136|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123137|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123138|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123139|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123140|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123141|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123142|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123143|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123144|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123145|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123146|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123147|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123148|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123149|NCT01481116|E3|Reported Event|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123150|NCT01481116|E2|Reported Event|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
123151|NCT01481116|E1|Reported Event|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
123152|NCT01480674|B1|Baseline|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123153|NCT01480674|P1|Participant Flow|Trastuzumab|Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123154|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123155|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123245|NCT01480219|B2|Baseline|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123156|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123157|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123158|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123159|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123160|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123161|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123162|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123163|NCT01480674|E1|Reported Event|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
123164|NCT01480596|B3|Baseline|Total|Total of all reporting groups
123165|NCT01480596|B2|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123166|NCT01480596|B1|Baseline|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123167|NCT01480596|P2|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123168|NCT01480596|P1|Participant Flow|Placebo IV|Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123169|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123170|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123171|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123172|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123173|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123174|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123175|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123176|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123177|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123178|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123179|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
144557|NCT01388816|O2|Outcome|DRL-17822 150 mg|Once daily after breakfast
123180|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123181|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123182|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123183|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123184|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123185|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123186|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123187|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123188|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123189|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123190|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123191|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123192|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123193|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123194|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123195|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123196|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123197|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123198|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123199|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123200|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123201|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123202|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123246|NCT01480219|B1|Baseline|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123203|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123204|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123205|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123206|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123207|NCT01480596|E2|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123208|NCT01480596|E1|Reported Event|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
123209|NCT01480297|B1|Baseline|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
123210|NCT01480297|P1|Participant Flow|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
123211|NCT01480297|O1|Outcome|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
123212|NCT01480297|E1|Reported Event|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
123213|NCT01480284|B3|Baseline|Total|Total of all reporting groups
123214|NCT01480284|B2|Baseline|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123215|NCT01480284|B1|Baseline|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123216|NCT01480284|P2|Participant Flow|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123217|NCT01480284|P1|Participant Flow|TDF 300 mg OD|Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks.
123218|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123219|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123220|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123221|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123222|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123223|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123224|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123225|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123226|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123227|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123228|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123229|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123230|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123231|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123232|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123233|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123234|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123235|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123236|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123237|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123238|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123239|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123240|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123241|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123242|NCT01480284|E2|Reported Event|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
123243|NCT01480284|E1|Reported Event|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
123244|NCT01480219|B3|Baseline|Total|Total of all reporting groups
144558|NCT01388816|O1|Outcome|DRL-17822 50 mg|Once daily after breakfast
123247|NCT01480219|P2|Participant Flow|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123248|NCT01480219|P1|Participant Flow|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123249|NCT01480219|O2|Outcome|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123250|NCT01480219|O1|Outcome|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123251|NCT01480219|E2|Reported Event|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123252|NCT01480219|E1|Reported Event|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
123253|NCT01480089|B3|Baseline|Total|Total of all reporting groups
123254|NCT01480089|B2|Baseline|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
123255|NCT01480089|B1|Baseline|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
123256|NCT01480089|P2|Participant Flow|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
123257|NCT01480089|P1|Participant Flow|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
123258|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
123259|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
123260|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
123261|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
123262|NCT01480089|E2|Reported Event|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
123263|NCT01480089|E1|Reported Event|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
123264|NCT01480076|B3|Baseline|Total|Total of all reporting groups
123265|NCT01480076|B2|Baseline|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
123266|NCT01480076|B1|Baseline|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
123267|NCT01480076|P1|Participant Flow|Fampridine|All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
123268|NCT01480076|O3|Outcome|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123269|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123270|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123271|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123272|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123273|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123274|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123275|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123276|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123438|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123277|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123278|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123279|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123280|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123281|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123282|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123283|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123284|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123285|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123286|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123287|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123288|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123289|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123290|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123291|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123292|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123293|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123294|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123295|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123296|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123297|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123298|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123299|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123300|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123301|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123302|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123439|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123303|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123304|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123305|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123306|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123307|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123308|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123309|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123310|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123311|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123312|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123313|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123314|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123315|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123316|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123317|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123318|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123319|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123320|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123321|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123322|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123323|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123324|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123325|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123326|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123327|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123328|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123329|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123330|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123331|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123332|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123333|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123334|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123335|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123336|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123337|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123338|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123339|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123340|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123341|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123342|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123343|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123344|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123345|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123346|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123347|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123348|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123349|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123350|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123351|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123352|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123353|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123440|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
144559|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
123354|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123355|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123356|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123357|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123358|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
123359|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123360|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123361|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123362|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123363|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123364|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123365|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123366|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123367|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123368|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123369|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123370|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123371|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123372|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123373|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123374|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123375|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123376|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123377|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123378|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123379|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123380|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123381|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
123382|NCT01480076|E3|Reported Event|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123383|NCT01480076|E2|Reported Event|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
123384|NCT01480076|E1|Reported Event|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
126037|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
123385|NCT01479868|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123386|NCT01479868|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123387|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123388|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123389|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123390|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123391|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123392|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123393|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123394|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123395|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123396|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
126038|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
123397|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123398|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123399|NCT01479868|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
123400|NCT01479777|B1|Baseline|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123401|NCT01479777|P1|Participant Flow|FES Stepping|For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
123402|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123403|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123404|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123405|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123406|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123407|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123408|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123409|NCT01479777|E1|Reported Event|FES Stepping|FES Stepping, twice a week, for 8 weeks.
123410|NCT01479764|B3|Baseline|Total|Total of all reporting groups
123411|NCT01479764|B2|Baseline|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
123412|NCT01479764|B1|Baseline|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
123413|NCT01479764|P2|Participant Flow|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
123414|NCT01479764|P1|Participant Flow|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
123415|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
123416|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
123417|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
123418|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
123419|NCT01479764|E2|Reported Event|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
123420|NCT01479764|E1|Reported Event|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
123421|NCT01479595|B3|Baseline|Total|Total of all reporting groups
123422|NCT01479595|B2|Baseline|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123423|NCT01479595|B1|Baseline|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123424|NCT01479595|P2|Participant Flow|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123425|NCT01479595|P1|Participant Flow|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123426|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123427|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123428|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123429|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123430|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123431|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123432|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123433|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123434|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123435|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123436|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
123437|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123445|NCT01479595|E1|Reported Event|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
123446|NCT01479543|B6|Baseline|Total|Total of all reporting groups
123447|NCT01479543|B5|Baseline|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
123448|NCT01479543|B4|Baseline|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123449|NCT01479543|B3|Baseline|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123450|NCT01479543|B2|Baseline|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
123451|NCT01479543|B1|Baseline|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
123452|NCT01479543|P5|Participant Flow|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
123453|NCT01479543|P4|Participant Flow|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123454|NCT01479543|P3|Participant Flow|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123455|NCT01479543|P2|Participant Flow|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
123456|NCT01479543|P1|Participant Flow|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
123457|NCT01479543|O5|Outcome|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
123458|NCT01479543|O4|Outcome|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123459|NCT01479543|O3|Outcome|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123460|NCT01479543|O2|Outcome|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
123461|NCT01479543|O1|Outcome|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
123462|NCT01479543|E5|Reported Event|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
123463|NCT01479543|E4|Reported Event|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123464|NCT01479543|E3|Reported Event|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
123465|NCT01479543|E2|Reported Event|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
123466|NCT01479543|E1|Reported Event|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
123467|NCT01479530|B3|Baseline|Total|Total of all reporting groups
123468|NCT01479530|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 16 weeks
123469|NCT01479530|B1|Baseline|Placebo|Once daily; tablet; orally; 16 weeks
123470|NCT01479530|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 16 weeks
123471|NCT01479530|P1|Participant Flow|Placebo|Once daily; tablet; orally; 16 weeks
123472|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
123473|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
123474|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
123475|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
123476|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
123477|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
123478|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
123479|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
123480|NCT01479530|E2|Reported Event|Azilect®|1 mg daily; tablet; orally; 16 weeks
123481|NCT01479530|E1|Reported Event|Placebo|Once daily; tablet; orally; 16 weeks
123482|NCT01479517|B4|Baseline|Total|Total of all reporting groups
123483|NCT01479517|B3|Baseline|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123484|NCT01479517|B2|Baseline|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123485|NCT01479517|B1|Baseline|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123486|NCT01479517|P3|Participant Flow|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123487|NCT01479517|P2|Participant Flow|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123488|NCT01479517|P1|Participant Flow|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123489|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123490|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123491|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123492|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123493|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123494|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123495|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123496|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123497|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123498|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123499|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123500|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123501|NCT01479517|E3|Reported Event|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
123502|NCT01479517|E2|Reported Event|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
123503|NCT01479517|E1|Reported Event|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
123504|NCT01479374|B4|Baseline|Total|Total of all reporting groups
123505|NCT01479374|B3|Baseline|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123506|NCT01479374|B2|Baseline|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123507|NCT01479374|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123508|NCT01479374|P3|Participant Flow|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123509|NCT01479374|P2|Participant Flow|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123510|NCT01479374|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123511|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123512|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123513|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123514|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123515|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123516|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123517|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123518|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123519|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123520|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123521|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123522|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123523|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123524|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123525|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123526|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123527|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123528|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123529|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123530|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123531|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123532|NCT01479374|E3|Reported Event|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
123533|NCT01479374|E2|Reported Event|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
123534|NCT01479374|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
123535|NCT01479127|B1|Baseline|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123589|NCT01478958|B3|Baseline|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
126039|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
123536|NCT01479127|P1|Participant Flow|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel [LCIG]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123537|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123538|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
123539|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123540|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
123541|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123542|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
123543|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123544|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
123545|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123546|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
123547|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123548|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123549|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123550|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123551|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123590|NCT01478958|B2|Baseline|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
123591|NCT01478958|B1|Baseline|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
123552|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123553|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123554|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123555|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123556|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123557|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123558|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123559|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123560|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123561|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123562|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
126040|NCT01470170|E5|Reported Event|Group 5 /Control|Propofol alone
123563|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123564|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123565|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123566|NCT01479127|O1|Outcome|Oral Levodopa/Carbidopa Tablet|During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)
123567|NCT01479127|E2|Reported Event|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
123568|NCT01479127|E1|Reported Event|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
123569|NCT01479010|B1|Baseline|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
123570|NCT01479010|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
123571|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
123572|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
123573|NCT01479010|E1|Reported Event|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
123574|NCT01478971|B1|Baseline|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
123575|NCT01478971|P1|Participant Flow|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
123576|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
123577|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
123578|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
123579|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
123580|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
123581|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
123582|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
123583|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
123584|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
123585|NCT01478971|E3|Reported Event|Peginesatide Treatment Period|In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).
123586|NCT01478971|E2|Reported Event|ESA Free Week|A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.
123587|NCT01478971|E1|Reported Event|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
123588|NCT01478958|B4|Baseline|Total|Total of all reporting groups
123592|NCT01478958|P3|Participant Flow|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
123593|NCT01478958|P2|Participant Flow|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
123594|NCT01478958|P1|Participant Flow|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
123595|NCT01478958|O3|Outcome|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
123596|NCT01478958|O2|Outcome|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
123597|NCT01478958|O1|Outcome|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
123598|NCT01478958|E3|Reported Event|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
123599|NCT01478958|E2|Reported Event|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
123600|NCT01478958|E1|Reported Event|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
123601|NCT01478828|B1|Baseline|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.~Lovastatin: oral qd varying dose escalations/de-escalations"
123602|NCT01478828|P1|Participant Flow|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
123603|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
123604|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
123605|NCT01478828|E1|Reported Event|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
123606|NCT01478620|B1|Baseline|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
123607|NCT01478620|P1|Participant Flow|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
123608|NCT01478620|O1|Outcome|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
123609|NCT01478620|E1|Reported Event|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
123610|NCT01478594|B3|Baseline|Total|Total of all reporting groups
123611|NCT01478594|B2|Baseline|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123612|NCT01478594|B1|Baseline|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123613|NCT01478594|P2|Participant Flow|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123614|NCT01478594|P1|Participant Flow|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m^2, leucovorin 400 mg/m^2, and 5-fluorouracil 400 mg/m^2 bolus then 2400 mg/m^2 every 2 weeks on Days 1 and 15 of each cycle.
123615|NCT01478594|O4|Outcome|Bevacizumab: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123616|NCT01478594|O3|Outcome|Bevacizumab: PIGF RNA < Median|Participants with PIGF RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123617|NCT01478594|O2|Outcome|Tivozanib: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123618|NCT01478594|O1|Outcome|Tivozanib: PIGF RNA < Median|Participants with PIGF RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123619|NCT01478594|O4|Outcome|Bevacizumab: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123842|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
126041|NCT01470170|E4|Reported Event|Group 4|alfentanil 5ug/kg two minutes before propofol
123620|NCT01478594|O3|Outcome|Bevacizumab: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123621|NCT01478594|O2|Outcome|Tivozanib: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123622|NCT01478594|O1|Outcome|Tivozanib: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123623|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123624|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123625|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123626|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123627|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123628|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123629|NCT01478594|O2|Outcome|Tivozanib: VEGF-C RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123630|NCT01478594|O1|Outcome|Tivozanib: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123631|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123632|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123633|NCT01478594|O2|Outcome|Tivozanib: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123634|NCT01478594|O1|Outcome|Tivozanib: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123635|NCT01478594|O4|Outcome|Bevacizumab: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123636|NCT01478594|O3|Outcome|Bevacizumab: Neuropilin < Median|Participants with neuropilin levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123637|NCT01478594|O2|Outcome|Tivozanib: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123638|NCT01478594|O1|Outcome|Tivozanib: Neuropilin < Median|Participants with neuropilin levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123639|NCT01478594|O4|Outcome|Bevacizumab: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123640|NCT01478594|O3|Outcome|Bevacizumab: IL-8 < Median|Participants with IL-8 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123641|NCT01478594|O2|Outcome|Tivozanib: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123642|NCT01478594|O1|Outcome|Tivozanib: IL-8 < Median|Participants with IL-8 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123643|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
126042|NCT01470170|E3|Reported Event|Group 3|alfentanil 5ug/kg immediately before propofol
123644|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123645|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123646|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123647|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123648|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123649|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123650|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123651|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123652|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123653|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123654|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123655|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123656|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C < Median|Participants with VEGF-C levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123657|NCT01478594|O2|Outcome|Tivozanib: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123658|NCT01478594|O1|Outcome|Tivozanib: VEGF-C < Median|Participants with VEGF-C levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123659|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123660|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A < Median|Participants with VEGF-A levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123661|NCT01478594|O2|Outcome|Tivozanib: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123662|NCT01478594|O1|Outcome|Tivozanib: VEGF-A < Median|Participants with VEGF-A levels < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123663|NCT01478594|O4|Outcome|Bevacizumab : LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123664|NCT01478594|O3|Outcome|Bevacizumab: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123665|NCT01478594|O2|Outcome|Tivozanib: LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123666|NCT01478594|O1|Outcome|Tivozanib: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123667|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123843|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
144560|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
123668|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123669|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123670|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123671|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123672|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123673|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123674|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123675|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123676|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123677|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123678|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123679|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123680|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123681|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123682|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123683|NCT01478594|E2|Reported Event|Bevacizumab + mFOLFOX6|Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123684|NCT01478594|E1|Reported Event|Tivozanib + mFOLFOX6|Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
123685|NCT01478373|B1|Baseline|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123686|NCT01478373|P1|Participant Flow|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123687|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123688|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123689|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123690|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123691|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123692|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123693|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123694|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123695|NCT01478373|E1|Reported Event|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
123696|NCT01478360|B3|Baseline|Total|Total of all reporting groups
123697|NCT01478360|B2|Baseline|Placebo|Placebo intravenous injection
123698|NCT01478360|B1|Baseline|AIN457|AIN457 10 mg/kg
123699|NCT01478360|P2|Participant Flow|Placebo|Placebo intravenous injection
123700|NCT01478360|P1|Participant Flow|AIN457|AIN457 10 mg/kg
123701|NCT01478360|O2|Outcome|Placebo|Placebo intravenous injection
123702|NCT01478360|O1|Outcome|AIN457|AIN457 10 mg/kg
123703|NCT01478360|E2|Reported Event|Placebo|Placebo
123704|NCT01478360|E1|Reported Event|AIN457 10 mg/kg|AIN457 10 mg/kg
123705|NCT01478347|B1|Baseline|rMenB+OMV NZ|"Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.~In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data."
123706|NCT01478347|P1|Participant Flow|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
123707|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
123708|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
123709|NCT01478347|E1|Reported Event|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
123710|NCT01478256|B3|Baseline|Total|Total of all reporting groups
123711|NCT01478256|B2|Baseline|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
123712|NCT01478256|B1|Baseline|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
123713|NCT01478256|P2|Participant Flow|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
123714|NCT01478256|P1|Participant Flow|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
123715|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
123716|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
123717|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
123718|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
123719|NCT01478256|E2|Reported Event|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
123720|NCT01478256|E1|Reported Event|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
123721|NCT01478087|B1|Baseline|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
123722|NCT01478087|P1|Participant Flow|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
123723|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
123724|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
123725|NCT01478087|E1|Reported Event|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
123726|NCT01478048|B3|Baseline|Total|Total of all reporting groups
123727|NCT01478048|B2|Baseline|Bortezomib + Dexamethasone|"Bortezomib: 1.3 mg/m^2 IV; (Cycles 1 - 8 on Days 1, 4, 8, 11; Cycles 9+ on Days 1, 8, 15.~Dexamethasone: 20 mg oral; (Cycles 1-8 QD on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ QD on Days 1, 2, 8, 9, 15, 16).~Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
123728|NCT01478048|B1|Baseline|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: 10 mg/kg Intravenous (IV): In Cycles 1 & 2: Treatment on Days 1, 8 & 15; In Cycles 3-8: on Days 1 & 11; In Cycle 9+: on Days 1 & 15.~Bortezomib: 1.3 mg/m^2 IV or subcutaneous; (Cycles 1 - 8: on Days 1, 4, 8, 11; Cycles 9+: on Days 1, 8, 15~Dexamethasone: On days of elotuzumab infusion, dexamethasone was administered as a split dose of 8mg oral 3 - 24 hours prior to elotuzumab followed by 8mg IV at least 45 minutes prior to elotuzumab. On other non-elotuzumab days, 20 mg oral dexamethasone was given once daily (QD) in Cycles 1 and 2 on Days 2, 4, 5, 9, 11; in Cycles 3 - 8 on Days 2, 4, 5, 8, 9, 12; in Cycles 9+ on Days 2, 8, 9, 16.~Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
123844|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123729|NCT01478048|P2|Participant Flow|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123730|NCT01478048|P1|Participant Flow|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123731|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123732|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123733|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123734|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123735|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123736|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123737|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123738|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123739|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
144561|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
123740|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123741|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123742|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123743|NCT01478048|E2|Reported Event|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
123744|NCT01478048|E1|Reported Event|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; IV; 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
123745|NCT01478009|B3|Baseline|Total|Total of all reporting groups
123746|NCT01478009|B2|Baseline|Placebo|
123747|NCT01478009|B1|Baseline|KRG Extract|
123748|NCT01478009|P2|Participant Flow|Placebo|"Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with KRG Extract."
123749|NCT01478009|P1|Participant Flow|KRG(Korean Red Ginseng) Extract|"KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks~KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)"
123750|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
123751|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
123752|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
123753|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
123754|NCT01478009|E2|Reported Event|Placebo|
123755|NCT01478009|E1|Reported Event|KRG Extract|
123756|NCT01477892|B3|Baseline|Total|Total of all reporting groups
123757|NCT01477892|B2|Baseline|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123758|NCT01477892|B1|Baseline|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123759|NCT01477892|P2|Participant Flow|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123760|NCT01477892|P1|Participant Flow|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123761|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123762|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123763|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123764|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123765|NCT01477892|E2|Reported Event|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123766|NCT01477892|E1|Reported Event|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
123767|NCT01477853|B4|Baseline|Total|Total of all reporting groups
123768|NCT01477853|B3|Baseline|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123769|NCT01477853|B2|Baseline|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123770|NCT01477853|B1|Baseline|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123771|NCT01477853|P3|Participant Flow|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123772|NCT01477853|P2|Participant Flow|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123773|NCT01477853|P1|Participant Flow|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123774|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123775|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123776|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123777|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123778|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123779|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123780|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123781|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123782|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123783|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123784|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123785|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123786|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123787|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123788|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123789|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123790|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123791|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123792|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123793|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123794|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123795|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123796|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123797|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123798|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123799|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123800|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123801|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123802|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123803|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123804|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123805|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123806|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123807|NCT01477853|E3|Reported Event|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
123808|NCT01477853|E2|Reported Event|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
123809|NCT01477853|E1|Reported Event|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
123845|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123846|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123847|NCT01477567|O5|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123810|NCT01477749|B1|Baseline|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123811|NCT01477749|P1|Participant Flow|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123812|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123813|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123814|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123815|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123816|NCT01477749|E1|Reported Event|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
123817|NCT01477710|B1|Baseline|All Participants|Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
123818|NCT01477710|P1|Participant Flow|All Participants|Each participant will perform 3 tasks -- in the same order. First, the clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, the clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
123819|NCT01477710|O3|Outcome|Airway|Using a supraglottic airway
123820|NCT01477710|O2|Outcome|Strap Mask|Mask is strapped to model using a securing device
123821|NCT01477710|O1|Outcome|Hold Mask|Mask is held in place by caregiver.
123822|NCT01477710|E3|Reported Event|Airway|
123823|NCT01477710|E2|Reported Event|Strap Mask|
123824|NCT01477710|E1|Reported Event|Hold Mask|
123825|NCT01477567|B8|Baseline|Total|Total of all reporting groups
123826|NCT01477567|B7|Baseline|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123827|NCT01477567|B6|Baseline|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123828|NCT01477567|B5|Baseline|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123829|NCT01477567|B4|Baseline|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123830|NCT01477567|B3|Baseline|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123831|NCT01477567|B2|Baseline|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123832|NCT01477567|B1|Baseline|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123833|NCT01477567|P7|Participant Flow|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123834|NCT01477567|P6|Participant Flow|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123835|NCT01477567|P5|Participant Flow|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123836|NCT01477567|P4|Participant Flow|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123837|NCT01477567|P3|Participant Flow|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123838|NCT01477567|P2|Participant Flow|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123839|NCT01477567|P1|Participant Flow|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123840|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123841|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123848|NCT01477567|O4|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123849|NCT01477567|O3|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123850|NCT01477567|O2|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123851|NCT01477567|O1|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123852|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123853|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123854|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123855|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123856|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123857|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123858|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123859|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123860|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123861|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123862|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123863|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123864|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123865|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123866|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123867|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123868|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123869|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123870|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123871|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123872|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123873|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123874|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123875|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123876|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123877|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123878|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123879|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123880|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123881|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123882|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123883|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123884|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123885|NCT01477567|E7|Reported Event|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
123886|NCT01477567|E6|Reported Event|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123887|NCT01477567|E5|Reported Event|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123888|NCT01477567|E4|Reported Event|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123889|NCT01477567|E3|Reported Event|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123890|NCT01477567|E2|Reported Event|1 mg LY3009385|LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
123891|NCT01477567|E1|Reported Event|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
123892|NCT01477463|B3|Baseline|Total|Total of all reporting groups
123893|NCT01477463|B2|Baseline|Arm B: Placebo|Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete
123894|NCT01477463|B1|Baseline|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123895|NCT01477463|P2|Participant Flow|Arm B: Placebo|Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
123896|NCT01477463|P1|Participant Flow|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123897|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo - inactive capsule
123898|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123899|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo (inactive capsule)
123900|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123901|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123902|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123903|NCT01477463|E2|Reported Event|Arm B: Placebo|Placebo (inactive capsule)
123904|NCT01477463|E1|Reported Event|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
123905|NCT01477450|B4|Baseline|Total|Total of all reporting groups
123906|NCT01477450|B3|Baseline|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123907|NCT01477450|B2|Baseline|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123908|NCT01477450|B1|Baseline|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123909|NCT01477450|P3|Participant Flow|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123910|NCT01477450|P2|Participant Flow|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123911|NCT01477450|P1|Participant Flow|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123912|NCT01477450|O3|Outcome|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123913|NCT01477450|O2|Outcome|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123914|NCT01477450|O1|Outcome|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123915|NCT01477450|E3|Reported Event|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123916|NCT01477450|E2|Reported Event|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123917|NCT01477450|E1|Reported Event|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
123918|NCT01475734|B3|Baseline|Total|Total of all reporting groups
123919|NCT01475734|B2|Baseline|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123920|NCT01475734|B1|Baseline|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123921|NCT01475734|P2|Participant Flow|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123922|NCT01475734|P1|Participant Flow|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123923|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123924|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123925|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123926|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
124003|NCT01476475|B3|Baseline|Total|Total of all reporting groups
124004|NCT01476475|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
144562|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
123927|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123928|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123929|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123930|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123931|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123932|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123933|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123934|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123935|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123936|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123937|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123938|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123939|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123940|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123941|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123942|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123943|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123944|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
124005|NCT01476475|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124006|NCT01476475|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
123945|NCT01475734|E2|Reported Event|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123946|NCT01475734|E1|Reported Event|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
123947|NCT01475721|B3|Baseline|Total|Total of all reporting groups
123948|NCT01475721|B2|Baseline|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123949|NCT01475721|B1|Baseline|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123950|NCT01475721|P2|Participant Flow|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123951|NCT01475721|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123952|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123953|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123954|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123955|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123956|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123957|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123958|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123959|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123960|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123961|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123962|NCT01475721|E2|Reported Event|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
124007|NCT01476475|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
124008|NCT01476475|O2|Outcome|Insulin Glargine (Lantus® SoloSTAR®)|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
123963|NCT01475721|E1|Reported Event|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
123964|NCT01476748|B4|Baseline|Total|Total of all reporting groups
123965|NCT01476748|B3|Baseline|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123966|NCT01476748|B2|Baseline|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123967|NCT01476748|B1|Baseline|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123968|NCT01476748|P3|Participant Flow|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123969|NCT01476748|P2|Participant Flow|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123970|NCT01476748|P1|Participant Flow|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123971|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123972|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123973|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123974|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123975|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123976|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123977|NCT01476748|E3|Reported Event|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123978|NCT01476748|E2|Reported Event|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123979|NCT01476748|E1|Reported Event|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
123980|NCT01476722|B1|Baseline|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123981|NCT01476722|P1|Participant Flow|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123982|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123983|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123984|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123985|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123986|NCT01476722|E1|Reported Event|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
123987|NCT01476696|B1|Baseline|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
123988|NCT01476696|P3|Participant Flow|Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose|"Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition."
123989|NCT01476696|P2|Participant Flow|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
124009|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
123990|NCT01476696|P1|Participant Flow|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
123991|NCT01476696|O1|Outcome|Part B: Prasugrel Once-Daily Dose|Part B: daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
123992|NCT01476696|O4|Outcome|Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)|Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
123993|NCT01476696|O3|Outcome|Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)|Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
123994|NCT01476696|O2|Outcome|Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)|Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
123995|NCT01476696|O1|Outcome|Part B: Baseline|Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).
123996|NCT01476696|O1|Outcome|Part A: Prasugrel Single Dose|Part A of the study: 0.03 up to 0.60 milligrams per kilogram (mg/kg) Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
123997|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
123998|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
123999|NCT01476696|E4|Reported Event|Part A and Part B Participants: During Part B|"Events reported during Part B for those participants who enrolled in Part A and Part B of study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
124000|NCT01476696|E3|Reported Event|Part A and Part B Participants: During Part A|"Events reported during Part A for those participants who enrolled in Part A and Part B of study.~Part A: 0.03 mg/kg up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses."
124001|NCT01476696|E2|Reported Event|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
124002|NCT01476696|E1|Reported Event|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
124010|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124011|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124012|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124013|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124014|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124015|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124016|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124017|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124018|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124019|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124020|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124021|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124022|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124023|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124024|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124025|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124026|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124027|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124028|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124029|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124030|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124031|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124032|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124033|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124034|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124035|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
124036|NCT01476475|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
124037|NCT01476475|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
124038|NCT01476345|B1|Baseline|All Participants|A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124039|NCT01476345|P2|Participant Flow|Lantus/LY/Lantus/LY|"Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
124040|NCT01476345|P1|Participant Flow|LY/Lantus/LY/Lantus|"Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
124041|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124042|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124043|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124044|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124045|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124046|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124047|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124048|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124049|NCT01476345|E2|Reported Event|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124050|NCT01476345|E1|Reported Event|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
124051|NCT01476202|B4|Baseline|Total|Total of all reporting groups
124052|NCT01476202|B3|Baseline|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
124053|NCT01476202|B2|Baseline|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
124054|NCT01476202|B1|Baseline|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
124055|NCT01476202|P3|Participant Flow|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
124056|NCT01476202|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
124057|NCT01476202|P1|Participant Flow|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
124058|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
124059|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
124060|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered single dose of 2.5 mg nicotine mouth strip.
124061|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
124062|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
124063|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
124064|NCT01476202|E3|Reported Event|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
124065|NCT01476202|E2|Reported Event|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
124066|NCT01476202|E1|Reported Event|Nicotine Mouth Strip 2.5 mg|Participants self administered single dose of 2.5 mg nicotine mouth strip.
124067|NCT01475955|B6|Baseline|Total|Total of all reporting groups
124068|NCT01475955|B5|Baseline|Vehicle (VEH) + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124069|NCT01475955|B4|Baseline|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124070|NCT01475955|B3|Baseline|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124071|NCT01475955|B2|Baseline|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124072|NCT01475955|B1|Baseline|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124073|NCT01475955|P5|Participant Flow|Vehicle + BLUE Light Treatment|"Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124074|NCT01475955|P4|Participant Flow|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124075|NCT01475955|P3|Participant Flow|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124076|NCT01475955|P2|Participant Flow|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124077|NCT01475955|P1|Participant Flow|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
124078|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124079|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124080|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124081|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124082|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124435|NCT01475851|B1|Baseline|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
125162|NCT01474109|E1|Reported Event|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
124083|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124084|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124085|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124086|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124087|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124088|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124089|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124090|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124091|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124092|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124093|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124094|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124095|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124096|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124097|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124098|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124099|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124100|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124101|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124102|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124103|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124104|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124105|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124106|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124107|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
125163|NCT01473992|B3|Baseline|Total|Total of all reporting groups
124108|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124109|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124110|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124111|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124112|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124113|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124114|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124115|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124116|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124117|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124118|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124119|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124120|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124121|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124122|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124123|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124124|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124125|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124126|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124127|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124128|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124129|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124130|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124131|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124132|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144563|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
124133|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124134|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124135|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124136|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124137|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124138|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124139|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124140|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124141|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124142|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124143|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124144|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124145|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124146|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124147|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124148|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124149|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124150|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124151|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124152|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124153|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124154|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124155|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124156|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124157|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144564|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
124158|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124159|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124160|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124161|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124162|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124163|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124164|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124165|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124166|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124167|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124168|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124169|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124170|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124171|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124172|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124173|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124174|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124175|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124176|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124177|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124178|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124179|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124180|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124181|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124182|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144565|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
124183|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124184|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124185|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124186|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124187|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124188|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124189|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124190|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124191|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124192|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124193|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124194|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124195|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124196|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124197|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124198|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124199|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124200|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124201|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124202|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124203|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124204|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124205|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124206|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124207|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144566|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
124208|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124209|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124210|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124211|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124212|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124213|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124214|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124215|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124216|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124217|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124218|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124219|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124220|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124221|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124222|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124223|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124224|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124225|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124226|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124227|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124228|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124229|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124230|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124231|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124232|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144567|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
124233|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124234|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124235|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124236|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124237|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124238|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124239|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124240|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124241|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124242|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124243|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124244|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124245|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124246|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124247|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124248|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124249|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124250|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124251|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124252|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124253|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124254|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124255|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124256|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124257|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124258|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124259|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124260|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124261|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124262|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124263|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124264|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124265|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124266|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124267|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124268|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124269|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124270|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124271|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124272|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124273|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124274|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124275|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124276|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124277|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124278|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124279|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124280|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124281|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
124282|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
144568|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
124283|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124284|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124285|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124286|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124287|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124288|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124289|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124290|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124291|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124292|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124293|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124294|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124295|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124296|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124297|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124298|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124299|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124300|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124301|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124302|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124303|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124304|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124305|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124306|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124307|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
125164|NCT01473992|B2|Baseline|Non Amputee Control Group|non-amputee healty controls
124308|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124309|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124310|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124311|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124312|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124313|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124314|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124315|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124316|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124317|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124318|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124319|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124320|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124321|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124322|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124323|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124324|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124325|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124326|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124327|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124328|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124329|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124330|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124331|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124332|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
125419|NCT01473589|B3|Baseline|Total|Total of all reporting groups
124333|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124334|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124335|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124336|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124337|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124338|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124339|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124340|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124341|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124342|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124343|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124344|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124345|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124346|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124347|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124348|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124349|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124350|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124351|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124352|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124353|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124354|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124355|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124356|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124357|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
125582|NCT01473368|O4|Outcome|Control|Control group
144569|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
124358|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124359|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124360|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124361|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124362|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124363|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124364|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124365|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124366|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124367|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124368|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124369|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124370|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124371|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124372|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124373|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124374|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124375|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124376|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5
124377|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
124378|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124379|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124380|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124381|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
124382|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
125634|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
124383|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124384|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124385|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124386|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124387|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124388|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124389|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124390|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124391|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124392|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124393|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124394|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124395|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124396|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124397|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124398|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124399|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124400|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124401|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124402|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124403|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124404|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124405|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124406|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124407|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124811|NCT01474538|E2|Reported Event|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124408|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124409|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124410|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124411|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124412|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124413|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124414|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124415|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124416|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.
124417|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124418|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124419|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124420|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124421|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124422|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124423|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
124424|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124425|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124426|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124427|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
124428|NCT01475955|E5|Reported Event|Vehicle PDT|"VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group."
124429|NCT01475955|E4|Reported Event|Spot ALA 2-hour|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
124430|NCT01475955|E3|Reported Event|Broad Area ALA 3-hour|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
124431|NCT01475955|E2|Reported Event|Broad Area ALA 2-hour|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
124432|NCT01475955|E1|Reported Event|Broad Area ALA 1-hour|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
124433|NCT01475851|B3|Baseline|Total|Total of all reporting groups
124434|NCT01475851|B2|Baseline|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124850|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124436|NCT01475851|P2|Participant Flow|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124437|NCT01475851|P1|Participant Flow|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124438|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124439|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124440|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124441|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124442|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124443|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124444|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124445|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124446|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124447|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124448|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124449|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124450|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124451|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124452|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124453|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124454|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124455|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124456|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124457|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124458|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124459|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124460|NCT01475851|E2|Reported Event|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
124461|NCT01475851|E1|Reported Event|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
124462|NCT01475838|B3|Baseline|Total|Total of all reporting groups
124463|NCT01475838|B2|Baseline|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124464|NCT01475838|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124465|NCT01475838|P2|Participant Flow|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124466|NCT01475838|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124851|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124467|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124468|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124469|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124470|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124471|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124472|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124473|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
124474|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
124475|NCT01475838|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
124476|NCT01475838|E2|Reported Event|PI+RTV+FTC/TDF|"Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
124477|NCT01475838|E1|Reported Event|Stribild|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
124478|NCT01475487|B3|Baseline|Total|Total of all reporting groups
124479|NCT01475487|B2|Baseline|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
124480|NCT01475487|B1|Baseline|Cricothyrotomy Using Digital Palpation|"Group-1 will perform Cricothyrotomy using conventional digital palpation technique~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
124481|NCT01475487|P2|Participant Flow|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124482|NCT01475487|P1|Participant Flow|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124483|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124484|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124499|NCT01475461|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
125635|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
124485|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124486|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124487|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124488|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124489|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124490|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124491|NCT01475487|E2|Reported Event|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
124492|NCT01475487|E1|Reported Event|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
124493|NCT01475474|B1|Baseline|Renew Insert for Management of Accidental Bowel Leakage|
124494|NCT01475474|P1|Participant Flow|Renew Insert for Management of Accidental Bowel Leakage|The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
124495|NCT01475474|O1|Outcome|Modified Intent to Treat Cohort (MITT)|Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
124496|NCT01475474|O1|Outcome|Modified Intent-To-Treat Cohort|Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
124497|NCT01475474|E1|Reported Event|Intent-to-treat (ITT) Cohort|Subjects who used the Renew Insert.
124498|NCT01475461|B7|Baseline|Total|Total of all reporting groups
124649|NCT01475097|B2|Baseline|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124500|NCT01475461|B5|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124501|NCT01475461|B4|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124502|NCT01475461|B3|Baseline|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124503|NCT01475461|B2|Baseline|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124504|NCT01475461|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124505|NCT01475461|P7|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124506|NCT01475461|P6|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124507|NCT01475461|P5|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124508|NCT01475461|P4|Participant Flow|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124509|NCT01475461|P3|Participant Flow|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124510|NCT01475461|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124511|NCT01475461|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
124512|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124513|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124514|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124515|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124516|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124517|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124518|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124519|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124520|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124521|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124522|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124523|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124524|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124525|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124526|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124527|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124528|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124529|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124530|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
124531|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124532|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124533|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124534|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124535|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124536|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124537|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
124538|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124539|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124540|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124541|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124542|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124543|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124544|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
124545|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124546|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124547|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124548|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124549|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124550|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124551|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124552|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124553|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124554|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124555|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124556|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124557|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124558|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124559|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124560|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124561|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124737|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124562|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124563|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124564|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124565|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124566|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124567|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124568|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124569|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124570|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124571|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124572|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124573|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124574|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124575|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124576|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124577|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124578|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124579|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124580|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124581|NCT01475461|E7|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124582|NCT01475461|E6|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124583|NCT01475461|E5|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124584|NCT01475461|E4|Reported Event|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124585|NCT01475461|E3|Reported Event|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
124586|NCT01475461|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
124587|NCT01475461|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
124588|NCT01475253|B4|Baseline|Total|Total of all reporting groups
124589|NCT01475253|B3|Baseline|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
124590|NCT01475253|B2|Baseline|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124591|NCT01475253|B1|Baseline|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124738|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124592|NCT01475253|P4|Participant Flow|LiRIS® 400 mg - Open Label Extension|LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
124593|NCT01475253|P3|Participant Flow|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
124594|NCT01475253|P2|Participant Flow|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124595|NCT01475253|P1|Participant Flow|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124596|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124597|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124598|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124599|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124600|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124601|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124602|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124603|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124604|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124605|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124606|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124607|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124608|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124609|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124610|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124611|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124612|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124613|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124614|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124615|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124616|NCT01475253|E4|Reported Event|LiRIS 400 mg - Open Label Extension|"LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine.~All subjects who completed the randomized study had the option to enter the open lable extension."
124617|NCT01475253|E3|Reported Event|Sham Cystoscopic Procedure - Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
124618|NCT01475253|E2|Reported Event|LiRIS® Placebo - Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124619|NCT01475253|E1|Reported Event|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
124620|NCT01475214|B4|Baseline|Total|Total of all reporting groups
124621|NCT01475214|B3|Baseline|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
124622|NCT01475214|B2|Baseline|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124623|NCT01475214|B1|Baseline|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124624|NCT01475214|P3|Participant Flow|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
124625|NCT01475214|P2|Participant Flow|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124626|NCT01475214|P1|Participant Flow|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124627|NCT01475214|O3|Outcome|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
124628|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124629|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124630|NCT01475214|O3|Outcome|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
124631|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124632|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124633|NCT01475214|E3|Reported Event|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
124634|NCT01475214|E2|Reported Event|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124635|NCT01475214|E1|Reported Event|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
124636|NCT01475175|B1|Baseline|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124637|NCT01475175|P1|Participant Flow|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124638|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124639|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124640|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124641|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124642|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124643|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124644|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124645|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124646|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124647|NCT01475175|E1|Reported Event|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
124648|NCT01475097|B3|Baseline|Total|Total of all reporting groups
125636|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
124650|NCT01475097|B1|Baseline|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124651|NCT01475097|P2|Participant Flow|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124652|NCT01475097|P1|Participant Flow|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124653|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124654|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124655|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124656|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124657|NCT01475097|E2|Reported Event|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124658|NCT01475097|E1|Reported Event|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
124659|NCT01475071|B1|Baseline|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
124660|NCT01475071|P1|Participant Flow|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
124661|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
124662|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
124663|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
124664|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
124665|NCT01475071|E2|Reported Event|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
124666|NCT01475071|E1|Reported Event|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
124667|NCT01474993|B3|Baseline|Total|Total of all reporting groups
124668|NCT01474993|B2|Baseline|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane.
124669|NCT01474993|B1|Baseline|Placebo|15 participants were randomized to placebo.
124670|NCT01474993|P2|Participant Flow|Sulforaphane-rich Broccoli Sprout Extract|"29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.~Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:~Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)~Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)~Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
124671|NCT01474993|P1|Participant Flow|Placebo|15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.
124672|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124673|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124674|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124675|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124739|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124740|NCT01474876|E1|Reported Event|Overall Study Population|Participants who received adalimumab treatment
124741|NCT01474772|B3|Baseline|Total|Total of all reporting groups
144570|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
124676|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124677|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124678|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124679|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124680|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124681|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124682|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124683|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124684|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124685|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124686|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
125637|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
124687|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124688|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124689|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124690|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient’s body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 – 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124691|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient’s body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 – 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
124692|NCT01474993|E2|Reported Event|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.
124693|NCT01474993|E1|Reported Event|Placebo|15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.
124694|NCT01474915|B3|Baseline|Total|Total of all reporting groups
124695|NCT01474915|B2|Baseline|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124696|NCT01474915|B1|Baseline|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124697|NCT01474915|P2|Participant Flow|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124698|NCT01474915|P1|Participant Flow|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124699|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
124700|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
124701|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
124702|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
124703|NCT01474915|E2|Reported Event|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124704|NCT01474915|E1|Reported Event|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
124705|NCT01474876|B4|Baseline|Total|Total of all reporting groups
124706|NCT01474876|B3|Baseline|Disease State Unknown|For one participant, information regarding the underlying disease was not available
124707|NCT01474876|B2|Baseline|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124708|NCT01474876|B1|Baseline|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124709|NCT01474876|P3|Participant Flow|Disease State Unknown|For one participant, information regarding the underlying disease was not available
124710|NCT01474876|P2|Participant Flow|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124711|NCT01474876|P1|Participant Flow|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124712|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124713|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124714|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124715|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124716|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124717|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124718|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124719|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124720|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124721|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124722|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124723|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124724|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124725|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124726|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124727|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124728|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124729|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124730|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124731|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124732|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124733|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124734|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124735|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
124736|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
124742|NCT01474772|B2|Baseline|Placebo/Pregabalin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124743|NCT01474772|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124744|NCT01474772|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124745|NCT01474772|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124746|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124747|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124748|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124749|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124750|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124751|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124752|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124753|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124807|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124852|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124754|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124755|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124756|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124757|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124758|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124759|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124760|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124761|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124762|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124763|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124764|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124808|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124765|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124766|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124767|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124768|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124769|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124770|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124771|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124772|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124773|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124774|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124775|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124809|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
125638|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
124776|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124777|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124778|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124779|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124780|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124781|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124782|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124783|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124784|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124785|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124786|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124810|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124787|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124788|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124789|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124790|NCT01474772|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124791|NCT01474772|E1|Reported Event|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
124792|NCT01474551|B1|Baseline|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
124793|NCT01474551|P1|Participant Flow|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
124794|NCT01474551|O1|Outcome|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
124795|NCT01474551|E1|Reported Event|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
124796|NCT01474538|B3|Baseline|Total|Total of all reporting groups
124797|NCT01474538|B2|Baseline|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
124798|NCT01474538|B1|Baseline|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
124799|NCT01474538|P2|Participant Flow|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
124800|NCT01474538|P1|Participant Flow|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
124801|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124802|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124803|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124804|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124805|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124806|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124812|NCT01474538|E1|Reported Event|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
124813|NCT01474512|B4|Baseline|Total|Total of all reporting groups
124814|NCT01474512|B3|Baseline|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
124815|NCT01474512|B2|Baseline|Ixe Q4W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
124816|NCT01474512|B1|Baseline|Placebo|Placebo administered as 2 SC injections Q2W up to Week 10.
124817|NCT01474512|P10|Participant Flow|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124818|NCT01474512|P9|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124819|NCT01474512|P8|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124820|NCT01474512|P7|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
124821|NCT01474512|P6|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124822|NCT01474512|P5|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56.
124823|NCT01474512|P4|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
124824|NCT01474512|P3|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 4, 6, 8, and 10.
124825|NCT01474512|P2|Participant Flow|Ixe Q4W - Induction Period|160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
124826|NCT01474512|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up to Week 10.
124827|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124828|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124829|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124830|NCT01474512|O4|Outcome|Ixe Q12W - Maintenance Period|80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
124831|NCT01474512|O3|Outcome|Ixe Q4W - Maintenance Period|80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
124832|NCT01474512|O2|Outcome|Ixe Q4W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124833|NCT01474512|O1|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124834|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124835|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124836|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124837|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124838|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124839|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124840|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124841|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124842|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124843|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124844|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124845|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124846|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124847|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124848|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124849|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124853|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124854|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124855|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124856|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124857|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124858|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124859|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124860|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124861|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124862|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124863|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124864|NCT01474512|O3|Outcome|Ixe/Q4W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
124865|NCT01474512|O2|Outcome|Ixe/Q12W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
124866|NCT01474512|O1|Outcome|Ixe/Placebo|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
124867|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124868|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124869|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124870|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124871|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124872|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124873|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124874|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124875|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124876|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
124877|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
124878|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
124879|NCT01474512|E11|Reported Event|Ixe Q4W - Maintenance Period Relapse Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124880|NCT01474512|E10|Reported Event|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124881|NCT01474512|E9|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124882|NCT01474512|E8|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124883|NCT01474512|E7|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
124884|NCT01474512|E6|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
124885|NCT01474512|E5|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56.
124886|NCT01474512|E4|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
124887|NCT01474512|E3|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 4, 6, 8 and 10.
124953|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124888|NCT01474512|E2|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
124889|NCT01474512|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 SC injections Q2W up to Week 10.
124890|NCT01474434|B5|Baseline|Total|Total of all reporting groups
124891|NCT01474434|B4|Baseline|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
124892|NCT01474434|B3|Baseline|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
124893|NCT01474434|B2|Baseline|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
124894|NCT01474434|B1|Baseline|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
124895|NCT01474434|P4|Participant Flow|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
124896|NCT01474434|P3|Participant Flow|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
124897|NCT01474434|P2|Participant Flow|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
124898|NCT01474434|P1|Participant Flow|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
124899|NCT01474434|O2|Outcome|Part B: Placebo|
124900|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
124901|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124902|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124903|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124904|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124905|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124906|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124907|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124908|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
125147|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
124909|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124910|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124911|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124912|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124913|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124914|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124915|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124916|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124917|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124918|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124919|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124920|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124921|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124922|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124923|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124924|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124925|NCT01474434|O2|Outcome|Part B: Placebo|
124926|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
124927|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124928|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124929|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124930|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124931|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124932|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124933|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
125148|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
124934|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124935|NCT01474434|E4|Reported Event|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124936|NCT01474434|E3|Reported Event|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
124937|NCT01474434|E2|Reported Event|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
124938|NCT01474434|E1|Reported Event|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
124939|NCT01474317|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124940|NCT01474317|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124941|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124942|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124943|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124944|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124945|NCT01474317|E1|Reported Event|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
124946|NCT01474291|B3|Baseline|Total|Total of all reporting groups
124947|NCT01474291|B2|Baseline|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124948|NCT01474291|B1|Baseline|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124949|NCT01474291|P1|Participant Flow|All Tocilizumab|Tocilizumab (RoActemra/Actemra) administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124950|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124951|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124952|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124954|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124955|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124956|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124957|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124958|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124959|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124960|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124961|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124962|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124963|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124964|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124965|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124966|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124967|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124968|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124969|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124970|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124971|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124972|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124973|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124974|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124975|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124976|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124977|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124978|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124979|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124980|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124981|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124982|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124983|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124984|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124985|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124986|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124987|NCT01474291|O1|Outcome|All Tocilizumab|Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124988|NCT01474291|E2|Reported Event|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
124989|NCT01474291|E1|Reported Event|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
124990|NCT01474239|B3|Baseline|Total|Total of all reporting groups
124991|NCT01474239|B2|Baseline|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
146757|NCT01377467|O2|Outcome|Control|No treatment
124992|NCT01474239|B1|Baseline|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124993|NCT01474239|P2|Participant Flow|Fotemustine|Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124994|NCT01474239|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124995|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124996|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124997|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124998|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
124999|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125000|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125001|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125002|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125003|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125004|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125005|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125006|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125007|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125008|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125009|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125010|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125011|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125012|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125013|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125014|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125015|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
147119|NCT01375764|B6|Baseline|Total|Total of all reporting groups
125016|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125017|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125018|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125019|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125020|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125021|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125022|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125023|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125024|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125025|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125026|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125027|NCT01474239|E2|Reported Event|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125028|NCT01474239|E1|Reported Event|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
125029|NCT01474213|B3|Baseline|Total|Total of all reporting groups
125030|NCT01474213|B2|Baseline|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125031|NCT01474213|B1|Baseline|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
125032|NCT01474213|P2|Participant Flow|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125033|NCT01474213|P1|Participant Flow|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
125034|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125035|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125036|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125037|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125038|NCT01474213|O2|Outcome|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125039|NCT01474213|O1|Outcome|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site (had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125040|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Three patients in dexmedetomidine group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
125041|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Two patients in remifentanil group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
125042|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125043|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125044|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125045|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125046|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125047|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125048|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125049|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125050|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
125051|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125052|NCT01474213|E2|Reported Event|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
125053|NCT01474213|E1|Reported Event|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
125054|NCT01474200|B3|Baseline|Total|Total of all reporting groups
125055|NCT01474200|B2|Baseline|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125056|NCT01474200|B1|Baseline|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125057|NCT01474200|P2|Participant Flow|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125058|NCT01474200|P1|Participant Flow|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125149|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
148676|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
125059|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125060|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125061|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125062|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125063|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125064|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125065|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125066|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125067|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125068|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125069|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125150|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125151|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125152|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125070|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125071|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125072|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125073|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125074|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125075|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125076|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125077|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125078|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125079|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125080|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125153|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125154|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125155|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125081|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125082|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125083|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125084|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125085|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125086|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125087|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125088|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125089|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125090|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125091|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125156|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125157|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125158|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125092|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125093|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125094|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125095|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125096|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125097|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125098|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125099|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125100|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125101|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125102|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125159|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125160|NCT01474109|E3|Reported Event|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125161|NCT01474109|E2|Reported Event|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125103|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125104|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125105|NCT01474200|E2|Reported Event|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
125106|NCT01474200|E1|Reported Event|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
125107|NCT01474122|B4|Baseline|Total|Total of all reporting groups
125108|NCT01474122|B3|Baseline|Placebo|Patients received placebo once daily.
125109|NCT01474122|B2|Baseline|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125110|NCT01474122|B1|Baseline|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125111|NCT01474122|P3|Participant Flow|Placebo|Patients received placebo once daily.
125112|NCT01474122|P2|Participant Flow|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125113|NCT01474122|P1|Participant Flow|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125114|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125115|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125116|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125117|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125118|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125119|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125120|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125121|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125122|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125123|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125124|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan 10mg once daily.
125125|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan 3mg once daily.
125126|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125127|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125128|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125129|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
125130|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125131|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125132|NCT01474122|E3|Reported Event|Placebo|Patients received placebo once daily.
125133|NCT01474122|E2|Reported Event|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
125134|NCT01474122|E1|Reported Event|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
125135|NCT01474109|B4|Baseline|Total|Total of all reporting groups
125136|NCT01474109|B3|Baseline|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125137|NCT01474109|B2|Baseline|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125138|NCT01474109|B1|Baseline|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125139|NCT01474109|P3|Participant Flow|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125140|NCT01474109|P2|Participant Flow|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125141|NCT01474109|P1|Participant Flow|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125142|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125143|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125144|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
125145|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
125146|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
125639|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125165|NCT01473992|B1|Baseline|Entire Study Population|Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first.
125166|NCT01473992|P3|Participant Flow|Control (Non-amputees)|Non-amputee control group
125167|NCT01473992|P2|Participant Flow|Prosthetic Knee 2 Then Prosthetic Knee 1|Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
125168|NCT01473992|P1|Participant Flow|Prosthetic Knee 1 Then Prosthetic Knee 2|Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
125169|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee control group
125170|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
125171|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
125172|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
125173|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
125174|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
125175|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
125176|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
125177|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
125178|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
125179|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
125180|NCT01473992|E2|Reported Event|Prosthetic Knee 2|Otto Bock Genium: Study knee.
125181|NCT01473992|E1|Reported Event|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
125182|NCT01473953|B6|Baseline|Total|Total of all reporting groups
125183|NCT01473953|B5|Baseline|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125184|NCT01473953|B4|Baseline|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125185|NCT01473953|B3|Baseline|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125186|NCT01473953|B2|Baseline|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125187|NCT01473953|B1|Baseline|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125188|NCT01473953|P5|Participant Flow|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125189|NCT01473953|P4|Participant Flow|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125190|NCT01473953|P3|Participant Flow|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125191|NCT01473953|P2|Participant Flow|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125192|NCT01473953|P1|Participant Flow|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125193|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125194|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125195|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125196|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125197|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125198|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125199|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125200|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125201|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125202|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125203|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125204|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125205|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125206|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125207|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125208|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125209|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125210|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125211|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125212|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125213|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125214|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
148677|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
125215|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125216|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125217|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125218|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125219|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125220|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125221|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125222|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125223|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125224|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125225|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125226|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125227|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125228|NCT01473953|E5|Reported Event|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
125229|NCT01473953|E4|Reported Event|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
125230|NCT01473953|E3|Reported Event|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
125231|NCT01473953|E2|Reported Event|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
125232|NCT01473953|E1|Reported Event|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
125233|NCT01473836|B1|Baseline|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125234|NCT01473836|P1|Participant Flow|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125235|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125236|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125237|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125238|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125239|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125240|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125241|NCT01473836|E1|Reported Event|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
125242|NCT01473758|B3|Baseline|Total|Total of all reporting groups
125243|NCT01473758|B2|Baseline|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125244|NCT01473758|B1|Baseline|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125245|NCT01473758|P4|Participant Flow|Placebo (Cycle 2)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
125246|NCT01473758|P3|Participant Flow|Roflumilast 500 µg (Cycle 2)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
125247|NCT01473758|P2|Participant Flow|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
125248|NCT01473758|P1|Participant Flow|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
125249|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125250|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125251|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125252|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125253|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125254|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125255|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125256|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125257|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125258|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125259|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125260|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125261|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125262|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125263|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125264|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125265|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125266|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125267|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125268|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125269|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125270|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125271|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125272|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125273|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125274|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125275|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125276|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125277|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125278|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
148678|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
125279|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125280|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125281|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125282|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125283|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125284|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125285|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125286|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125287|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125288|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125289|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125290|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125291|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125292|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125293|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125294|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125295|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125296|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125297|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125298|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125299|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125300|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125301|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125302|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125303|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125304|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125305|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125306|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125307|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125308|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125309|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125310|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125311|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125312|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125313|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125640|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
125314|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125315|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125316|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125317|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125318|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125319|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125320|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125321|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125322|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125323|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125324|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125325|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125326|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125327|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125328|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125329|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125330|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125331|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125332|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125333|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125334|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125335|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125336|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125337|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125338|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125339|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125340|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125341|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125342|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125343|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125344|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125345|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125346|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125347|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125348|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125641|NCT01472939|E4|Reported Event|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125349|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125350|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125351|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125352|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125353|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125354|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125355|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125356|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125357|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125358|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125359|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125360|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125361|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125362|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125363|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125364|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
125365|NCT01473758|E4|Reported Event|Placebo (Extended Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
125366|NCT01473758|E3|Reported Event|Roflumilast 500 µg (Extended Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
125367|NCT01473758|E2|Reported Event|Placebo (Initial Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
125368|NCT01473758|E1|Reported Event|Roflumilast 500 μg (Initial Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
125369|NCT01473745|B3|Baseline|Total|Total of all reporting groups
125370|NCT01473745|B2|Baseline|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125371|NCT01473745|B1|Baseline|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125372|NCT01473745|P2|Participant Flow|Modified Alar Cinch Group|Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
125373|NCT01473745|P1|Participant Flow|Conventional Alar Cinch Group|Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
125374|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125375|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125376|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125377|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125378|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
148679|NCT01369745|O5|Outcome|Placebo|placebo once daily
125379|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125380|NCT01473745|E2|Reported Event|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125381|NCT01473745|E1|Reported Event|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base.~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
125382|NCT01473602|B3|Baseline|Total|Total of all reporting groups
125383|NCT01473602|B2|Baseline|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125384|NCT01473602|B1|Baseline|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125385|NCT01473602|P2|Participant Flow|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125386|NCT01473602|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125387|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125388|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125389|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125390|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125391|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125392|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125393|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125394|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125395|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125396|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125397|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125398|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125399|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125400|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125401|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125402|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125403|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125404|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125405|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125406|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125407|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125408|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125409|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125410|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125411|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125412|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125413|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125414|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125415|NCT01473602|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125416|NCT01473602|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125417|NCT01473602|E2|Reported Event|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125418|NCT01473602|E1|Reported Event|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125420|NCT01473589|B2|Baseline|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125421|NCT01473589|B1|Baseline|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125422|NCT01473589|P2|Participant Flow|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125423|NCT01473589|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
125424|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125425|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125426|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125427|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125428|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125429|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125430|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125431|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125432|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125433|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125434|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125435|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125436|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125437|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125438|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125439|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125440|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125441|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125442|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125443|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125444|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125445|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125446|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125447|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125448|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125449|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125450|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125451|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125452|NCT01473589|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125453|NCT01473589|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125454|NCT01473589|E2|Reported Event|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125455|NCT01473589|E1|Reported Event|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
125456|NCT01473563|B1|Baseline|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125457|NCT01473563|P1|Participant Flow|Pemetrexed|Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125458|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125459|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125460|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125461|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125462|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125463|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125464|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125465|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125466|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125467|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125468|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125469|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125470|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125471|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125472|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125473|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125474|NCT01473563|E1|Reported Event|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
125475|NCT01473524|B4|Baseline|Total|Total of all reporting groups
125476|NCT01473524|B3|Baseline|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125477|NCT01473524|B2|Baseline|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125642|NCT01472939|E3|Reported Event|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
152240|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
125478|NCT01473524|B1|Baseline|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125479|NCT01473524|P3|Participant Flow|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125480|NCT01473524|P2|Participant Flow|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125481|NCT01473524|P1|Participant Flow|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125482|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125483|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125484|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125485|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125486|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125487|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125488|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125489|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125490|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125491|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125492|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125493|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125494|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125495|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125496|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125497|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125498|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125499|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125500|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125501|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125502|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125503|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125504|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125505|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125506|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125507|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125508|NCT01473524|E3|Reported Event|Placebo|One tablet daily for double-blind period. After completion of the 1 year double-blind period period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125509|NCT01473524|E2|Reported Event|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
125510|NCT01473524|E1|Reported Event|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
125511|NCT01473394|B3|Baseline|Total|Total of all reporting groups
125512|NCT01473394|B2|Baseline|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125513|NCT01473394|B1|Baseline|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125514|NCT01473394|P2|Participant Flow|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125515|NCT01473394|P1|Participant Flow|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125516|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125517|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125518|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125519|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125520|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125521|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125522|NCT01473394|E2|Reported Event|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
125523|NCT01473394|E1|Reported Event|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
125524|NCT01473381|B5|Baseline|Total|Total of all reporting groups
125525|NCT01473381|B4|Baseline|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125526|NCT01473381|B3|Baseline|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
125527|NCT01473381|B2|Baseline|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125528|NCT01473381|B1|Baseline|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125529|NCT01473381|P4|Participant Flow|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125530|NCT01473381|P3|Participant Flow|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
125531|NCT01473381|P2|Participant Flow|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125532|NCT01473381|P1|Participant Flow|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125533|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125534|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days
125535|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125536|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125537|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125538|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
125539|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125540|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125541|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125542|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
125543|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125544|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125545|NCT01473381|E4|Reported Event|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
125546|NCT01473381|E3|Reported Event|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
125643|NCT01472939|E2|Reported Event|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125644|NCT01472939|E1|Reported Event|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
125547|NCT01473381|E2|Reported Event|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
125548|NCT01473381|E1|Reported Event|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
125549|NCT01473368|B5|Baseline|Total|Total of all reporting groups
125550|NCT01473368|B4|Baseline|Control|control group
125551|NCT01473368|B3|Baseline|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125552|NCT01473368|B2|Baseline|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125553|NCT01473368|B1|Baseline|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125554|NCT01473368|P4|Participant Flow|Control|Control group
125555|NCT01473368|P3|Participant Flow|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125556|NCT01473368|P2|Participant Flow|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125557|NCT01473368|P1|Participant Flow|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125558|NCT01473368|O7|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
125559|NCT01473368|O6|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
125560|NCT01473368|O5|Outcome|Core Microbiome|Core Microbiome
125561|NCT01473368|O4|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
125562|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
125563|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
125564|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
125565|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
125566|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
125567|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) Before Treatment|"Before treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
125568|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
125569|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
125570|NCT01473368|O1|Outcome|Antibiotic (Amoxicillin Clavulanate) Before Treatment|"Before treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
125571|NCT01473368|O3|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
125572|NCT01473368|O2|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
125573|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii) Before Treatment|"Before treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
125574|NCT01473368|O4|Outcome|Control|Control group
125575|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125576|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125577|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125578|NCT01473368|O4|Outcome|Control|Control group
125579|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125580|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125581|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125583|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125584|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125585|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125586|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125587|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125588|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125589|NCT01473368|E4|Reported Event|Control|
125590|NCT01473368|E3|Reported Event|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
125591|NCT01473368|E2|Reported Event|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
125592|NCT01473368|E1|Reported Event|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
125593|NCT01473160|B1|Baseline|Overall Study|All enrolled participants
125594|NCT01473160|P1|Participant Flow|Overall Study|All enrolled participants
125595|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125596|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125597|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125598|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125599|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125600|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125601|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125602|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125603|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125604|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125605|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125606|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125607|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125608|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125609|NCT01473160|E2|Reported Event|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
125610|NCT01473160|E1|Reported Event|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
125611|NCT01472939|B5|Baseline|Total|Total of all reporting groups
125612|NCT01472939|B4|Baseline|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125613|NCT01472939|B3|Baseline|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125614|NCT01472939|B2|Baseline|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125615|NCT01472939|B1|Baseline|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
125616|NCT01472939|P4|Participant Flow|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125617|NCT01472939|P3|Participant Flow|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125618|NCT01472939|P2|Participant Flow|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125619|NCT01472939|P1|Participant Flow|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
125620|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125621|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125622|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125623|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125624|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125625|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125626|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125627|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125628|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125629|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125630|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
125631|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
125632|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
125633|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
125645|NCT01472874|B1|Baseline|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125646|NCT01472874|P1|Participant Flow|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125647|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125648|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125649|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125650|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125651|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125652|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125653|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125654|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125655|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125656|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125657|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125658|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125659|NCT01472874|E1|Reported Event|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
125660|NCT01472835|B3|Baseline|Total|Total of all reporting groups
125661|NCT01472835|B2|Baseline|Control|Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
125662|NCT01472835|B1|Baseline|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125663|NCT01472835|P2|Participant Flow|Control|Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
125664|NCT01472835|P1|Participant Flow|Sedation|"Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125665|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
125666|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125667|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
125668|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125669|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure
125670|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125671|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
125672|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125673|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
125674|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125675|NCT01472835|E2|Reported Event|Control|Patient did not receive sedation during procedure
125676|NCT01472835|E1|Reported Event|Sedation|"Pt received sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
125677|NCT01472822|B3|Baseline|Total|Total of all reporting groups
125678|NCT01472822|B2|Baseline|Placebo|
125679|NCT01472822|B1|Baseline|Omija|
125680|NCT01472822|P2|Participant Flow|Placebo|"Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Omija extract.."
125681|NCT01472822|P1|Participant Flow|Omija Extract.|"Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Omija extract.: Omija extracted with ethanol and then concentrated and dried."
125682|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
125683|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
125684|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
125685|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
125686|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
125687|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
125688|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
125689|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
125690|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
125691|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
125692|NCT01472822|E2|Reported Event|Placebo|
125693|NCT01472822|E1|Reported Event|Omija|
125694|NCT01472432|B3|Baseline|Total|Total of all reporting groups
125695|NCT01472432|B2|Baseline|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125696|NCT01472432|B1|Baseline|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125697|NCT01472432|P2|Participant Flow|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125698|NCT01472432|P1|Participant Flow|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125699|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125737|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125738|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125700|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125701|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea"
125702|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~Placebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea"
125703|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125704|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125705|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125706|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125707|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125708|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125709|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125710|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125711|NCT01472432|E2|Reported Event|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
125712|NCT01472432|E1|Reported Event|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
125713|NCT01472380|B1|Baseline|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
125714|NCT01472380|P1|Participant Flow|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
125715|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
125716|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
125717|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
125718|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
125719|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
125720|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
125721|NCT01472380|E3|Reported Event|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
125722|NCT01472380|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
125723|NCT01472380|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
125724|NCT01472341|B1|Baseline|All Participants|Participants receiving routine care under a diabetologist.
125725|NCT01472341|P1|Participant Flow|All Participants|Participants receiving routine care under a diabetologist.
125726|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
125727|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
125728|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
125729|NCT01472341|E1|Reported Event|All Participants|Participants receiving routine care under a diabetologist.
125730|NCT01472289|B1|Baseline|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125731|NCT01472289|P1|Participant Flow|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125732|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125733|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125734|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125735|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125736|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125965|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
125739|NCT01472289|E1|Reported Event|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
125740|NCT01472185|B3|Baseline|Total|Total of all reporting groups
125741|NCT01472185|B2|Baseline|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125742|NCT01472185|B1|Baseline|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125743|NCT01472185|P2|Participant Flow|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125744|NCT01472185|P1|Participant Flow|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125745|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125746|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125747|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125748|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125749|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125750|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125751|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125752|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125753|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125754|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125755|NCT01472185|E2|Reported Event|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125756|NCT01472185|E1|Reported Event|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
125757|NCT01471782|B7|Baseline|Total|Total of all reporting groups
125758|NCT01471782|B6|Baseline|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125759|NCT01471782|B5|Baseline|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125760|NCT01471782|B4|Baseline|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125761|NCT01471782|B3|Baseline|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
152241|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
125762|NCT01471782|B2|Baseline|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125763|NCT01471782|B1|Baseline|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125764|NCT01471782|P6|Participant Flow|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125765|NCT01471782|P5|Participant Flow|Phase 1: Blinatumomab 5/15 µg/m²/Day|PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125766|NCT01471782|P4|Participant Flow|Phase 1: Blinatumomab 15/30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125767|NCT01471782|P3|Participant Flow|Phase 1: Blinatumomab 30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125768|NCT01471782|P2|Participant Flow|Phase 1: Blinatumomab 15 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125769|NCT01471782|P1|Participant Flow|Phase 1: Blinatumomab 5 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125770|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
125771|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
125772|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
125773|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125774|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125775|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125776|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125777|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125778|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125779|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125780|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125781|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125782|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125783|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125907|NCT01471171|B1|Baseline|Overall Study Safety Population|All patients randomized into the crossover study were included in the safety population
125784|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125785|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125786|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125787|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125788|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125789|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125790|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125791|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125792|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125793|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125794|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125795|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
125796|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
125797|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
125798|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125799|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125800|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125801|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125802|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125803|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125804|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125805|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125906|NCT01471197|E1|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125806|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125807|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125808|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125809|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125810|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125811|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125812|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125813|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125814|NCT01471782|E6|Reported Event|Total|All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
125815|NCT01471782|E5|Reported Event|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125816|NCT01471782|E4|Reported Event|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
125817|NCT01471782|E3|Reported Event|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
125818|NCT01471782|E2|Reported Event|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125819|NCT01471782|E1|Reported Event|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
125820|NCT01471691|B3|Baseline|Total|Total of all reporting groups
125821|NCT01471691|B2|Baseline|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
125822|NCT01471691|B1|Baseline|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
125823|NCT01471691|P2|Participant Flow|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
125824|NCT01471691|P1|Participant Flow|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
125825|NCT01471691|O2|Outcome|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
125826|NCT01471691|O1|Outcome|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
125827|NCT01471691|E2|Reported Event|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
125828|NCT01471691|E1|Reported Event|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
125829|NCT01471626|B1|Baseline|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
125830|NCT01471626|P1|Participant Flow|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
125831|NCT01471626|O1|Outcome|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
126019|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
125832|NCT01471626|E1|Reported Event|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
125833|NCT01471574|B5|Baseline|Total|Total of all reporting groups
125834|NCT01471574|B4|Baseline|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125835|NCT01471574|B3|Baseline|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125836|NCT01471574|B2|Baseline|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125837|NCT01471574|B1|Baseline|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125838|NCT01471574|P4|Participant Flow|Non-­HAART Therapy|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125839|NCT01471574|P3|Participant Flow|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125840|NCT01471574|P2|Participant Flow|HAART: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125841|NCT01471574|P1|Participant Flow|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125842|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125843|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125844|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125845|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
126020|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
125846|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125847|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125848|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30, 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125849|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125850|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125851|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125852|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125853|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125854|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125855|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125856|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125857|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125858|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
126021|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
125859|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125860|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125861|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125862|NCT01471574|O3|Outcome|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125863|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125864|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125865|NCT01471574|E4|Reported Event|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125866|NCT01471574|E3|Reported Event|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125867|NCT01471574|E2|Reported Event|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125868|NCT01471574|E1|Reported Event|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
125869|NCT01471379|B4|Baseline|Total|Total of all reporting groups
125870|NCT01471379|B3|Baseline|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125871|NCT01471379|B2|Baseline|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125872|NCT01471379|B1|Baseline|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125873|NCT01471379|P3|Participant Flow|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125874|NCT01471379|P2|Participant Flow|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125875|NCT01471379|P1|Participant Flow|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125876|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125877|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125878|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125879|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125880|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125881|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125882|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125883|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125884|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125885|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125886|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125887|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125888|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125889|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125890|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125891|NCT01471379|E3|Reported Event|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
125892|NCT01471379|E2|Reported Event|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
125893|NCT01471379|E1|Reported Event|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
125894|NCT01471197|B3|Baseline|Total|Total of all reporting groups
125895|NCT01471197|B2|Baseline|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
125896|NCT01471197|B1|Baseline|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125897|NCT01471197|P2|Participant Flow|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
125898|NCT01471197|P1|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125899|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
125900|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125901|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
125902|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125903|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
125904|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
125905|NCT01471197|E2|Reported Event|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
126022|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
125908|NCT01471171|P2|Participant Flow|Placebo - Aclidinium Bromide 400 μg|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125909|NCT01471171|P1|Participant Flow|Aclidinium Bromide 400 μg - Placebo|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125910|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
125911|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125912|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
125913|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125914|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
125915|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125916|NCT01471171|E2|Reported Event|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
125917|NCT01471171|E1|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
125918|NCT01471041|B1|Baseline|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
125919|NCT01471041|P1|Participant Flow|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
125920|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
125921|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
125922|NCT01471041|E1|Reported Event|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
125923|NCT01471015|B4|Baseline|Total|Total of all reporting groups
125924|NCT01471015|B3|Baseline|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
125925|NCT01471015|B2|Baseline|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125926|NCT01471015|B1|Baseline|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125927|NCT01471015|P3|Participant Flow|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
125928|NCT01471015|P2|Participant Flow|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125929|NCT01471015|P1|Participant Flow|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125930|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125931|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125932|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125964|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
125933|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125934|NCT01471015|O3|Outcome|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
125935|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125936|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125937|NCT01471015|E3|Reported Event|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
125938|NCT01471015|E2|Reported Event|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
125939|NCT01471015|E1|Reported Event|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
125940|NCT01470859|B3|Baseline|Total|Total of all reporting groups
125941|NCT01470859|B2|Baseline|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125942|NCT01470859|B1|Baseline|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125943|NCT01470859|P2|Participant Flow|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125944|NCT01470859|P1|Participant Flow|Levodopa|"Sinemet Controlled Release (CR)~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125945|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125946|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125947|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125948|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125949|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125950|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125951|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125952|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125953|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125954|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125955|NCT01470859|E2|Reported Event|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
125956|NCT01470859|E1|Reported Event|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
125957|NCT01470651|B3|Baseline|Total|Total of all reporting groups
125958|NCT01470651|B2|Baseline|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
125959|NCT01470651|B1|Baseline|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
125960|NCT01470651|P2|Participant Flow|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
125961|NCT01470651|P1|Participant Flow|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
125962|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
125963|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
125966|NCT01470651|E2|Reported Event|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
125967|NCT01470651|E1|Reported Event|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
125968|NCT01470469|B3|Baseline|Total|Total of all reporting groups
125969|NCT01470469|B2|Baseline|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125970|NCT01470469|B1|Baseline|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125971|NCT01470469|P2|Participant Flow|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125972|NCT01470469|P1|Participant Flow|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125973|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125974|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125975|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125976|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125977|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125978|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125979|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125980|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125981|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125982|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125983|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125984|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125985|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125986|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125987|NCT01470469|E2|Reported Event|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
125988|NCT01470469|E1|Reported Event|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
125989|NCT01470417|B3|Baseline|Total|Total of all reporting groups
125990|NCT01470417|B2|Baseline|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
125991|NCT01470417|B1|Baseline|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
125992|NCT01470417|P2|Participant Flow|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
125993|NCT01470417|P1|Participant Flow|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
125994|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
125995|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
126023|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
125996|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
125997|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
125998|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
125999|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
126000|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
126001|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
126002|NCT01470417|E2|Reported Event|Chemotherapy and ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
126003|NCT01470417|E1|Reported Event|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
126004|NCT01470170|B6|Baseline|Total|Total of all reporting groups
126005|NCT01470170|B5|Baseline|Group 5/ Control|Propofol alone
126006|NCT01470170|B4|Baseline|Group 4|alfentanil 5ug/kg two minutes before propofol
126007|NCT01470170|B3|Baseline|Group 3|alfentanil 5ug/kg immediately before propofol
126008|NCT01470170|B2|Baseline|Group 2|alfentanil 2.5ug/kg two minutes before propofol
126009|NCT01470170|B1|Baseline|Group1|alfentanil 2.5ug/kg immediately before propofol
126010|NCT01470170|P5|Participant Flow|Group 5 Control|TCI propofol administration alone
126011|NCT01470170|P4|Participant Flow|Group 4|Alfentanil 5μg/kg two minutes before TCI propofol administration
126012|NCT01470170|P3|Participant Flow|Group 3|Alfentanil 2.5μg/kg two minutes before TCI propofol administration
126013|NCT01470170|P2|Participant Flow|Group2|Alfentanil 5μg/kg immediately before TCI propofol administration
126014|NCT01470170|P1|Participant Flow|Group1|Alfentanil 2.5μg/kg immediately before TCI propofol administration
126015|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
126016|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
126017|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
126018|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
152242|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
126043|NCT01470170|E2|Reported Event|Group 2|alfentanil 2.5ug/kg two minutes before propofol
126044|NCT01470170|E1|Reported Event|Group1|alfentanil 2.5ug/kg immediately before propofol
126045|NCT01470144|B1|Baseline|Treatment|All patients who received at least one dose of EFI
126046|NCT01470144|P1|Participant Flow|Treatment|All patients who received at least one dose of EFI
126047|NCT01470144|O1|Outcome|Treatment|
126048|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
126049|NCT01470144|E1|Reported Event|Treatment|
126050|NCT01470118|B4|Baseline|Total|Total of all reporting groups
126051|NCT01470118|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126052|NCT01470118|B2|Baseline|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126053|NCT01470118|B1|Baseline|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126054|NCT01470118|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126055|NCT01470118|P2|Participant Flow|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126056|NCT01470118|P1|Participant Flow|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126057|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126058|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126059|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126060|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126061|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126062|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126063|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126064|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126065|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126066|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126067|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126068|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126069|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126070|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126071|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126072|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126073|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126074|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126075|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126076|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126077|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126078|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126079|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126080|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126081|NCT01470118|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
126082|NCT01470118|E2|Reported Event|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126083|NCT01470118|E1|Reported Event|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
126084|NCT01469819|B1|Baseline|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
126085|NCT01469819|P1|Participant Flow|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
126086|NCT01469819|O1|Outcome|SIBO (+)|Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
126087|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement
126200|NCT01469065|P1|Participant Flow|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126088|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
126089|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement.
126090|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
126091|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
126092|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
126093|NCT01469819|E1|Reported Event|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
126094|NCT01469715|B1|Baseline|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
126095|NCT01469715|P1|Participant Flow|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
126096|NCT01469715|O1|Outcome|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
126097|NCT01469715|E1|Reported Event|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
126098|NCT01469637|B3|Baseline|Total|Total of all reporting groups
126099|NCT01469637|B2|Baseline|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
126100|NCT01469637|B1|Baseline|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
126101|NCT01469637|P2|Participant Flow|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
126102|NCT01469637|P1|Participant Flow|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
126103|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
126201|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126104|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
126105|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
126106|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
126107|NCT01469637|E2|Reported Event|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
126108|NCT01469637|E1|Reported Event|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
126109|NCT01469546|B1|Baseline|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126110|NCT01469546|P1|Participant Flow|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126111|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126112|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126113|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126114|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126115|NCT01469546|E1|Reported Event|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
126116|NCT01469364|B1|Baseline|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126117|NCT01469364|P1|Participant Flow|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126118|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126119|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126120|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126121|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126144|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126145|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126202|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126122|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126123|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126124|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126125|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126126|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126127|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126128|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126129|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126130|NCT01469364|E1|Reported Event|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
126131|NCT01469234|B4|Baseline|Total|Total of all reporting groups
126132|NCT01469234|B3|Baseline|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126133|NCT01469234|B2|Baseline|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126134|NCT01469234|B1|Baseline|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126135|NCT01469234|P3|Participant Flow|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126136|NCT01469234|P2|Participant Flow|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126137|NCT01469234|P1|Participant Flow|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126138|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126139|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126140|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126141|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126142|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126143|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126203|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126146|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126147|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126148|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126149|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126150|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126151|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126152|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126153|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126154|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126155|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126156|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126157|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126158|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126159|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126160|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126161|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126162|NCT01469234|E3|Reported Event|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
126163|NCT01469234|E2|Reported Event|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
126164|NCT01469234|E1|Reported Event|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
126165|NCT01469182|B3|Baseline|Total|Total of all reporting groups
126166|NCT01469182|B2|Baseline|Placebo|Matching placebo tablet, sublingual, once daily.
126167|NCT01469182|B1|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126168|NCT01469182|P2|Participant Flow|Placebo|Matching placebo tablet, sublingual, once daily.
126169|NCT01469182|P1|Participant Flow|SCH 39641 12 Amb a 1-U|12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.
126170|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126171|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126172|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126173|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126174|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126175|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126176|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126177|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126178|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126179|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126180|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126181|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126182|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126183|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126184|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126185|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126186|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
126187|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126188|NCT01469182|E2|Reported Event|Placebo|Matching placebo tablet, sublingual, once daily.
126189|NCT01469182|E1|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
126190|NCT01469065|B6|Baseline|Total|Total of all reporting groups
126191|NCT01469065|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126192|NCT01469065|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126193|NCT01469065|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126194|NCT01469065|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126195|NCT01469065|B1|Baseline|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126196|NCT01469065|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126197|NCT01469065|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126198|NCT01469065|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126199|NCT01469065|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126204|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126205|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126206|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126207|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126208|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126209|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126210|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126211|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126212|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126213|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126214|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126215|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126216|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126217|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126218|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126219|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126220|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126221|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126222|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126223|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126224|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126225|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126226|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126227|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126228|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126229|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126230|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126231|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126232|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126233|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126234|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126235|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126236|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126237|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126238|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126239|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126240|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126241|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126242|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126243|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126244|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126245|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126246|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126247|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126248|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126249|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126250|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126251|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126252|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126253|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126254|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126255|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126256|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126257|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126258|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126259|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126260|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126261|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126262|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126263|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126264|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126265|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126266|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126267|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126268|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126269|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126270|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126271|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126272|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126273|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126274|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126275|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126276|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126277|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126278|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126279|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126280|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126281|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126282|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126283|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126284|NCT01469065|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
126285|NCT01469065|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
126286|NCT01469065|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
126287|NCT01469065|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
126288|NCT01469065|E1|Reported Event|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
126289|NCT01469052|B7|Baseline|Total|Total of all reporting groups
126290|NCT01469052|B6|Baseline|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126291|NCT01469052|B5|Baseline|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126292|NCT01469052|B4|Baseline|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126293|NCT01469052|B3|Baseline|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126294|NCT01469052|B2|Baseline|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126295|NCT01469052|B1|Baseline|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126296|NCT01469052|P6|Participant Flow|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126297|NCT01469052|P5|Participant Flow|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126298|NCT01469052|P4|Participant Flow|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126299|NCT01469052|P3|Participant Flow|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126300|NCT01469052|P2|Participant Flow|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126301|NCT01469052|P1|Participant Flow|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126302|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
126303|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
126304|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
126305|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
126306|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
126307|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
126308|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
126309|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
126310|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
126311|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
126312|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126313|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126314|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126315|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126316|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126317|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126318|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126319|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126320|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126321|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126322|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126323|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126324|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126325|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126326|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126327|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126328|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126329|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126330|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126331|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126332|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126333|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126334|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126335|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126336|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126337|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
126338|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126339|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126340|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126341|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
126342|NCT01469052|O1|Outcome|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
126343|NCT01469052|E1|Reported Event|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
126345|NCT01469039|B3|Baseline|Placebo|Intramuscular injection, given monthly
126346|NCT01469039|B2|Baseline|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
126347|NCT01469039|B1|Baseline|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
126348|NCT01469039|P3|Participant Flow|Placebo|Intramuscular injection, given monthly
126349|NCT01469039|P2|Participant Flow|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
126350|NCT01469039|P1|Participant Flow|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
126351|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
126352|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
126353|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
126354|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
126355|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
126356|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
126357|NCT01469039|E3|Reported Event|Placebo|Intramuscular injection, given monthly
126358|NCT01469039|E2|Reported Event|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
126359|NCT01469039|E1|Reported Event|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
126360|NCT01469000|B3|Baseline|Total|Total of all reporting groups
126361|NCT01469000|B2|Baseline|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126362|NCT01469000|B1|Baseline|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126363|NCT01469000|P2|Participant Flow|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126364|NCT01469000|P1|Participant Flow|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126365|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126366|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126367|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126368|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126369|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126370|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126371|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126372|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126373|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126374|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126375|NCT01469000|E2|Reported Event|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
126376|NCT01469000|E1|Reported Event|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
126377|NCT01468818|B1|Baseline|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
126378|NCT01468818|P1|Participant Flow|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
126379|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
126406|NCT01468350|O4|Outcome|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
126380|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
126381|NCT01468818|E1|Reported Event|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
126382|NCT01468584|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
126383|NCT01468584|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
126384|NCT01468584|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
126385|NCT01468584|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
126386|NCT01468558|B1|Baseline|Overall Study|All subjects that were enrolled in the study.
126387|NCT01468558|P1|Participant Flow|Overall Study|Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.
126388|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
126389|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
126390|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
126391|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
126392|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
126393|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
126394|NCT01468558|E3|Reported Event|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
126395|NCT01468558|E2|Reported Event|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
126396|NCT01468558|E1|Reported Event|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
126397|NCT01468350|B5|Baseline|Total|Total of all reporting groups
126398|NCT01468350|B4|Baseline|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
126399|NCT01468350|B3|Baseline|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
126400|NCT01468350|B2|Baseline|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
126401|NCT01468350|B1|Baseline|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
126402|NCT01468350|P4|Participant Flow|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
126403|NCT01468350|P3|Participant Flow|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
126404|NCT01468350|P2|Participant Flow|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
126405|NCT01468350|P1|Participant Flow|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
126407|NCT01468350|O3|Outcome|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
126408|NCT01468350|O2|Outcome|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
126409|NCT01468350|O1|Outcome|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
126410|NCT01468350|E4|Reported Event|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
126411|NCT01468350|E3|Reported Event|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
126412|NCT01468350|E2|Reported Event|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
126413|NCT01468350|E1|Reported Event|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
126414|NCT01468337|B1|Baseline|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126415|NCT01468337|P1|Participant Flow|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126416|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126417|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126418|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126419|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126439|NCT01468233|O2|Outcome|Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126440|NCT01468233|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
127772|NCT01463878|O2|Outcome|Control - Jevity|The control arm of the study. Patients to receive Jevity
126420|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126421|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126422|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126423|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126424|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126425|NCT01468337|E1|Reported Event|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
126426|NCT01468233|B3|Baseline|Total|Total of all reporting groups
126427|NCT01468233|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126428|NCT01468233|B1|Baseline|Placebo|Placebo for 12 weeks
126429|NCT01468233|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126430|NCT01468233|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
126431|NCT01468233|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126432|NCT01468233|P3|Participant Flow|Placebo/Placebo|Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126433|NCT01468233|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126434|NCT01468233|P1|Participant Flow|Placebo|Placebo for 12 weeks
126435|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126436|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
126437|NCT01468233|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126438|NCT01468233|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
126661|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126441|NCT01468233|O6|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126442|NCT01468233|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126443|NCT01468233|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
126444|NCT01468233|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
126445|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126446|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
126447|NCT01468233|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126448|NCT01468233|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
126449|NCT01468233|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126450|NCT01468233|E3|Reported Event|Placebo/Placebo (Period 2)|Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126451|NCT01468233|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126452|NCT01468233|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks.
126453|NCT01468207|B3|Baseline|Total|Total of all reporting groups
126454|NCT01468207|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126455|NCT01468207|B1|Baseline|Placebo|Placebo for 12 weeks.
126456|NCT01468207|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126457|NCT01468207|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
126458|NCT01468207|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126459|NCT01468207|P3|Participant Flow|Placebo/Adalimumab Every Week (EW)|Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
126460|NCT01468207|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126461|NCT01468207|P1|Participant Flow|Placebo|Placebo for 12 weeks.
126462|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126463|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
126464|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126465|NCT01468207|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
126466|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126467|NCT01468207|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
126468|NCT01468207|O6|Outcome|Adalimumab Every Week (ew) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126469|NCT01468207|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
126470|NCT01468207|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
126471|NCT01468207|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
126472|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126473|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
126474|NCT01468207|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126475|NCT01468207|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
126476|NCT01468207|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
126662|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126477|NCT01468207|E3|Reported Event|Placebo/Adalimumab EW (Period 2)|Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).
126478|NCT01468207|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
126479|NCT01468207|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks
126480|NCT01468181|B6|Baseline|Total|Total of all reporting groups
126481|NCT01468181|B5|Baseline|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126482|NCT01468181|B4|Baseline|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126483|NCT01468181|B3|Baseline|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126484|NCT01468181|B2|Baseline|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126485|NCT01468181|B1|Baseline|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126486|NCT01468181|P5|Participant Flow|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126487|NCT01468181|P4|Participant Flow|LY2189265 + Thiazolidin Edione (TZD)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126488|NCT01468181|P3|Participant Flow|LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126489|NCT01468181|P2|Participant Flow|LY2189265 + Biguanides (BG)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126490|NCT01468181|P1|Participant Flow|LY2189265 + Sulfonylureas (SU)|"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126491|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126492|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126493|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126494|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126495|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126496|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126497|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126498|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126499|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126500|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126501|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126502|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126503|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126504|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126505|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126506|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126507|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126508|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126509|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126510|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126511|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126512|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126513|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126514|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126515|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126516|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126517|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126518|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126519|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126520|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126521|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126522|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126523|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126524|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126525|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126526|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126527|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126528|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126529|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126530|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126531|NCT01468181|E5|Reported Event|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
126532|NCT01468181|E4|Reported Event|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
126533|NCT01468181|E3|Reported Event|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
126534|NCT01468181|E2|Reported Event|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
126535|NCT01468181|E1|Reported Event|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
126536|NCT01468077|B3|Baseline|Total|Total of all reporting groups
126537|NCT01468077|B2|Baseline|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126538|NCT01468077|B1|Baseline|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126539|NCT01468077|P2|Participant Flow|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126540|NCT01468077|P1|Participant Flow|Tocilizumab, Normal Administration|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126541|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126542|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126543|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126544|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126545|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126546|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126547|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126548|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126549|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126550|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126551|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126552|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126553|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126554|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126555|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126556|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126557|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126558|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126559|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126560|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126561|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126562|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126563|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126564|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126565|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126566|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
127773|NCT01463878|O1|Outcome|Glycerna|Diabetic specific formula
126567|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126568|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126569|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126570|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126571|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126572|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126573|NCT01468077|E2|Reported Event|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
126574|NCT01468077|E1|Reported Event|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
126575|NCT01468012|B4|Baseline|Total|Total of all reporting groups
126576|NCT01468012|B3|Baseline|Non-randomized|
126577|NCT01468012|B2|Baseline|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
126578|NCT01468012|B1|Baseline|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
126579|NCT01468012|P3|Participant Flow|Non-randomized|
126580|NCT01468012|P2|Participant Flow|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
126581|NCT01468012|P1|Participant Flow|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
126582|NCT01468012|O2|Outcome|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
126583|NCT01468012|O1|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
126584|NCT01468012|E2|Reported Event|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
126585|NCT01468012|E1|Reported Event|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
126586|NCT01467960|B7|Baseline|Total|Total of all reporting groups
126587|NCT01467960|B6|Baseline|Group C|Patients at stage > than II, H&Y
126588|NCT01467960|B5|Baseline|Group B|Patients at Stage II, H&Y
126589|NCT01467960|B4|Baseline|Group A|Patients at Stage I, H&Y
126590|NCT01467960|B3|Baseline|Group III|Healthy Subjects aged more than 65
126591|NCT01467960|B2|Baseline|Group II|Healthy Subjects aged 40-65
126592|NCT01467960|B1|Baseline|Group I|Healthy Subjects aged 20-40
126593|NCT01467960|P6|Participant Flow|Group C|30 Patients at Stage more than III, H&Y classification
126594|NCT01467960|P5|Participant Flow|Group B|30 Patients at Stage II, H&Y classification
126595|NCT01467960|P4|Participant Flow|Group A|30 Patients at Stage I, H&Y classification
126596|NCT01467960|P3|Participant Flow|Group III|30 Healthy Subjects aged more than 65
126597|NCT01467960|P2|Participant Flow|Group II|30 Healthy Subjects aged 40-65
126598|NCT01467960|P1|Participant Flow|Group I|30 Healthy Subjects aged 20-40
126599|NCT01467960|O6|Outcome|Group C|Patients at stage > than II, H&Y
126600|NCT01467960|O5|Outcome|Group B|Patients at Stage II, H&Y
126601|NCT01467960|O4|Outcome|Group A|Patients at Stage I, H&Y
126602|NCT01467960|O3|Outcome|Group III|Healthy Subjects aged more than 65
126603|NCT01467960|O2|Outcome|Group II|Healthy Subjects aged 40-65
126604|NCT01467960|O1|Outcome|Group I|Healthy Subjects aged 20-40
126605|NCT01467960|E6|Reported Event|Group C|Patients at stage > than II, H&Y
126606|NCT01467960|E5|Reported Event|Group B|Patients at Stage II, H&Y
126607|NCT01467960|E4|Reported Event|Group A|Patients at Stage I, H&Y
126608|NCT01467960|E3|Reported Event|Group III|Healthy Subjects aged more than 65
126609|NCT01467960|E2|Reported Event|Group II|Healthy Subjects aged 40-65
126610|NCT01467960|E1|Reported Event|Group I|Healthy Subjects aged 20-40
126611|NCT01467947|B1|Baseline|C1 Esterase Inhibitor|Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
126612|NCT01467947|P1|Participant Flow|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
126613|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
126614|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
126663|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126615|NCT01467947|E1|Reported Event|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
126616|NCT01467934|B4|Baseline|Total|Total of all reporting groups
126617|NCT01467934|B3|Baseline|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126618|NCT01467934|B2|Baseline|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126619|NCT01467934|B1|Baseline|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
126620|NCT01467934|P3|Participant Flow|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
126621|NCT01467934|P2|Participant Flow|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126622|NCT01467934|P1|Participant Flow|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine 0.25ml IM X 1
126623|NCT01467934|O3|Outcome|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126624|NCT01467934|O2|Outcome|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126625|NCT01467934|O1|Outcome|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
126626|NCT01467934|E3|Reported Event|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126627|NCT01467934|E2|Reported Event|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
126628|NCT01467934|E1|Reported Event|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
126629|NCT01467882|B1|Baseline|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126630|NCT01467882|P1|Participant Flow|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126631|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126632|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126633|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126634|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126635|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126636|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126637|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126638|NCT01467882|O1|Outcome|AOC Subset|All children in AOC subset who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126639|NCT01467882|O3|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126640|NCT01467882|O2|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126641|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126642|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126643|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126644|NCT01467882|O2|Outcome|All Children Follicle Stimulating Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126645|NCT01467882|O1|Outcome|All Children Luteinizing Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126646|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126647|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126648|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126649|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126650|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126651|NCT01467882|E1|Reported Event|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
126652|NCT01467713|B5|Baseline|Total|Total of all reporting groups
126653|NCT01467713|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126654|NCT01467713|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126655|NCT01467713|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126656|NCT01467713|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126657|NCT01467713|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126658|NCT01467713|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126659|NCT01467713|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126660|NCT01467713|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126664|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126665|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126666|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126667|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126668|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126669|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126670|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126671|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126672|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126673|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126674|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126675|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126676|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126677|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126678|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126679|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126680|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126681|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126682|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126683|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126684|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126685|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126686|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126687|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126688|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126689|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126690|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126691|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126692|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126693|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126694|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126695|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126696|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126697|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126698|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126699|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126700|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126701|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126702|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126703|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126704|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126705|NCT01467713|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126706|NCT01467713|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
126707|NCT01467713|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
128186|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
126708|NCT01467713|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
126709|NCT01467700|B5|Baseline|Total|Total of all reporting groups
126710|NCT01467700|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126711|NCT01467700|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126712|NCT01467700|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126713|NCT01467700|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126714|NCT01467700|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126715|NCT01467700|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126716|NCT01467700|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126717|NCT01467700|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126718|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126719|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126720|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126721|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126722|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126723|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126724|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126725|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126726|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126727|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126728|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126729|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126730|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126731|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126732|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126733|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126734|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126735|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126736|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126737|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126738|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126739|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126740|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126741|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126742|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126743|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126744|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126745|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126746|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126747|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126748|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126749|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126750|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126751|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
126752|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
127158|NCT01466387|P1|Participant Flow|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
126753|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126754|NCT01467700|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126755|NCT01467700|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
126756|NCT01467700|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
126757|NCT01467700|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
126758|NCT01467661|B1|Baseline|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126759|NCT01467661|P1|Participant Flow|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126760|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126761|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126762|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126763|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126764|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126765|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126766|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126767|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126768|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126769|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126770|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126771|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126772|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
126773|NCT01467661|E2|Reported Event|SPD422: Post-marketing Trial Safety Analysis Set|Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
126774|NCT01467661|E1|Reported Event|SPD422: Safety Analysis Set|Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
126775|NCT01467583|B4|Baseline|Total|Total of all reporting groups
126776|NCT01467583|B3|Baseline|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
126777|NCT01467583|B2|Baseline|Renal Failure, on CRRT|Fondaparinux: 2.5 mg every 48 hours
126778|NCT01467583|B1|Baseline|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
126779|NCT01467583|P3|Participant Flow|Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
128187|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
126780|NCT01467583|P2|Participant Flow|Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours|These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
126781|NCT01467583|P1|Participant Flow|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
126782|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
126783|NCT01467583|O2|Outcome|Renal Failure-renal Replacement Therapy|"These are patients with renal failure, either acute or chronic, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
126784|NCT01467583|O1|Outcome|Renal Failure on Intermittent Dialysis (IHD)|"These are patients with renal failure, on IHD, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
126785|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
126786|NCT01467583|O2|Outcome|Renal Failure-continuous Renal Replacement Therapy|These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
126787|NCT01467583|O1|Outcome|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
126788|NCT01467583|E3|Reported Event|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
126789|NCT01467583|E2|Reported Event|Renal Failure-continuous Renal Replacement Therapy|These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
126790|NCT01467583|E1|Reported Event|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
126791|NCT01467570|B3|Baseline|Total|Total of all reporting groups
126792|NCT01467570|B2|Baseline|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126793|NCT01467570|B1|Baseline|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126794|NCT01467570|P2|Participant Flow|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126795|NCT01467570|P1|Participant Flow|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126796|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126797|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126798|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126799|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126800|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126801|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126802|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126803|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126804|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126805|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126806|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126807|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126808|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126950|NCT01466790|B8|Baseline|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126809|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126810|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126811|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126812|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126813|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126814|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126815|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126816|NCT01467570|E2|Reported Event|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126817|NCT01467570|E1|Reported Event|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
126818|NCT01467557|B3|Baseline|Total|Total of all reporting groups
126819|NCT01467557|B2|Baseline|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
126820|NCT01467557|B1|Baseline|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
126821|NCT01467557|P2|Participant Flow|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
126822|NCT01467557|P1|Participant Flow|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
126823|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126824|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126825|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126826|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126827|NCT01467557|E2|Reported Event|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126828|NCT01467557|E1|Reported Event|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
126829|NCT01467505|B3|Baseline|Total|Total of all reporting groups
126830|NCT01467505|B2|Baseline|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126831|NCT01467505|B1|Baseline|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126832|NCT01467505|P2|Participant Flow|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126846|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126833|NCT01467505|P1|Participant Flow|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126834|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126835|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126836|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126837|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126838|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126839|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126840|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126841|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126842|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126843|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126844|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126845|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126947|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
127159|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
126847|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126848|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126849|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126850|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126851|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126852|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126853|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126854|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126855|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126856|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126857|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126858|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126859|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126860|NCT01467505|E2|Reported Event|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126861|NCT01467505|E1|Reported Event|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
126862|NCT01467492|B3|Baseline|Total|Total of all reporting groups
126863|NCT01467492|B2|Baseline|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126864|NCT01467492|B1|Baseline|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126865|NCT01467492|P2|Participant Flow|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126866|NCT01467492|P1|Participant Flow|Group A - Black|Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126867|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126868|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126869|NCT01467492|O1|Outcome|All Participants|All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126870|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126871|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126872|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126873|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126874|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126875|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126876|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126877|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126878|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126879|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
127055|NCT01466595|B1|Baseline|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
126880|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126881|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126882|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126883|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126884|NCT01467492|E2|Reported Event|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126885|NCT01467492|E1|Reported Event|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
126886|NCT01467479|B4|Baseline|Total|Total of all reporting groups
126887|NCT01467479|B3|Baseline|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126888|NCT01467479|B2|Baseline|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126889|NCT01467479|B1|Baseline|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126890|NCT01467479|P3|Participant Flow|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126891|NCT01467479|P2|Participant Flow|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126892|NCT01467479|P1|Participant Flow|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126893|NCT01467479|O1|Outcome|T/PR + HAART Regimen|Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
126894|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126895|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126896|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
152243|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
126897|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126898|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126899|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126900|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126901|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126902|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126903|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126904|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126905|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126906|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126907|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126908|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126909|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126910|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126911|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126948|NCT01466881|E1|Reported Event|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126949|NCT01466790|B9|Baseline|Total|Total of all reporting groups
126912|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126913|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126914|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126915|NCT01467479|E3|Reported Event|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126916|NCT01467479|E2|Reported Event|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126917|NCT01467479|E1|Reported Event|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
126918|NCT01467076|B4|Baseline|Total|Total of all reporting groups
126919|NCT01467076|B3|Baseline|High Dose IPGE1|300 ng/kg/min
126920|NCT01467076|B2|Baseline|Low Dose IPGE1|150 ng/kg/min
126921|NCT01467076|B1|Baseline|Control|Aerosolized saline
126922|NCT01467076|P3|Participant Flow|High Dose IPGE1|300 ng/kg/min
126923|NCT01467076|P2|Participant Flow|Low Dose IPGE1|150 ng/kg/min
126924|NCT01467076|P1|Participant Flow|Control|Aerosolized saline
126925|NCT01467076|O3|Outcome|High Dose IPGE1|300 ng/kg/min
126926|NCT01467076|O2|Outcome|Low Dose IPGE1|150 ng/kg/min
126927|NCT01467076|O1|Outcome|Control|Aerosolized saline
126928|NCT01467076|E3|Reported Event|High Dose IPGE1|300 ng/kg/min
126929|NCT01467076|E2|Reported Event|Low Dose IPGE1|150 ng/kg/min
126930|NCT01467076|E1|Reported Event|Control|Aerosolized saline
126931|NCT01467037|B3|Baseline|Total|Total of all reporting groups
126932|NCT01467037|B2|Baseline|Rotavirus -Positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
126933|NCT01467037|B1|Baseline|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
126934|NCT01467037|P1|Participant Flow|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
126935|NCT01467037|O2|Outcome|≥1 Versus 0 Dose|We compared Rotavirus VE between patients that received 1 versus 0 dose of RV1.
126936|NCT01467037|O1|Outcome|2 Versus 0 Doses|We compared Rotavirus VE between patients that received 2 versus 0 doses of RV1.
126937|NCT01467037|O2|Outcome|Rotavirus-positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
126938|NCT01467037|O1|Outcome|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
126939|NCT01467037|E1|Reported Event|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
126940|NCT01466881|B1|Baseline|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126941|NCT01466881|P1|Participant Flow|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126942|NCT01466881|O2|Outcome|Responders|Eligible Patients who received protocol treatment and achieved complete or partial response.
126943|NCT01466881|O1|Outcome|Non-responders|Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
126944|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126945|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126946|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
126951|NCT01466790|B7|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126952|NCT01466790|B6|Baseline|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126953|NCT01466790|B5|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126954|NCT01466790|B4|Baseline|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126955|NCT01466790|B3|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126956|NCT01466790|B2|Baseline|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126957|NCT01466790|B1|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126958|NCT01466790|P8|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126959|NCT01466790|P7|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126960|NCT01466790|P6|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126961|NCT01466790|P5|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126962|NCT01466790|P4|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126963|NCT01466790|P3|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126964|NCT01466790|P2|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126965|NCT01466790|P1|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126966|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126967|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126968|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126969|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126970|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127056|NCT01466595|P2|Participant Flow|Arm B: No Study Treatment|No study treatment for 4 weeks
152244|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
126971|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126972|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126973|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126974|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126975|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126976|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126977|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126978|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126979|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126980|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126981|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126982|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126983|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126984|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126985|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126986|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126987|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126988|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126989|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126990|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127057|NCT01466595|P1|Participant Flow|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
126991|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126992|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126993|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126994|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126995|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
126996|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
126997|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
126998|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
126999|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127000|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127001|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127002|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127003|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127004|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127005|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127006|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127007|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127008|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127009|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127010|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127058|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127774|NCT01463878|E2|Reported Event|Control - Jevity|The control arm of the study. Patients to receive Jevity
127011|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127012|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127013|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127014|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127015|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127016|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127017|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127018|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127019|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127020|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127021|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127022|NCT01466790|E4|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
127023|NCT01466790|E3|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
127024|NCT01466790|E2|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
127025|NCT01466790|E1|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
127026|NCT01466673|B3|Baseline|Total|Total of all reporting groups
127027|NCT01466673|B2|Baseline|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127028|NCT01466673|B1|Baseline|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127029|NCT01466673|P2|Participant Flow|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127030|NCT01466673|P1|Participant Flow|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127031|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127059|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127032|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127033|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127034|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127035|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127036|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127037|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127038|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127039|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127040|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127041|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127042|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127043|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127044|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127045|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127046|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127047|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127048|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127049|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127050|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127051|NCT01466673|E2|Reported Event|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
127052|NCT01466673|E1|Reported Event|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
127053|NCT01466595|B3|Baseline|Total|Total of all reporting groups
127054|NCT01466595|B2|Baseline|Arm B: No Study Treatment|No study treatment for 4 weeks
127060|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127061|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127062|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127063|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127064|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127065|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127066|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127067|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127068|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127069|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127070|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127071|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127072|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127073|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127074|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127075|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127076|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127077|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127078|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127079|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127080|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127081|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127082|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127083|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127084|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127085|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127086|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127087|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127088|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127089|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127090|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127091|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127092|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127093|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127094|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127095|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127096|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127097|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127098|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127099|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127100|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127101|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127102|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127103|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127104|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127105|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127106|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127107|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127108|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127109|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127110|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127775|NCT01463878|E1|Reported Event|Glycerna|Diabetic specific formula
127111|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127112|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127113|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127114|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127115|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127116|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127117|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127118|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127119|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127120|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127121|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127122|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127123|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127124|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127125|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127126|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127127|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127128|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127129|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127130|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127131|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127132|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127133|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127134|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127135|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127136|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127137|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127138|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127139|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127140|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127141|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127142|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
127143|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127144|NCT01466595|E2|Reported Event|Arm B: No Study Treatment|No study treatment for 4 weeks
127145|NCT01466595|E1|Reported Event|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
127146|NCT01466387|B7|Baseline|Total|Total of all reporting groups
127147|NCT01466387|B6|Baseline|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127148|NCT01466387|B5|Baseline|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
127149|NCT01466387|B4|Baseline|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127150|NCT01466387|B3|Baseline|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
127151|NCT01466387|B2|Baseline|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127152|NCT01466387|B1|Baseline|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
127153|NCT01466387|P6|Participant Flow|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127154|NCT01466387|P5|Participant Flow|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
127155|NCT01466387|P4|Participant Flow|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127156|NCT01466387|P3|Participant Flow|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
127157|NCT01466387|P2|Participant Flow|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127776|NCT01463696|B9|Baseline|Total|Total of all reporting groups
127160|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127161|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 yars of age who received three doses of Rabies vaccine.
127162|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
127163|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127164|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
127165|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
127166|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127167|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127168|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127169|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127170|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127171|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127172|NCT01466387|O1|Outcome|TF + YF + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127173|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127174|NCT01466387|O1|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127175|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
127176|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
127177|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127178|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
127179|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127180|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
127181|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
127182|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
127183|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
127184|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
127185|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127186|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
127187|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127188|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
127189|NCT01466387|E6|Reported Event|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
127190|NCT01466387|E5|Reported Event|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
127191|NCT01466387|E4|Reported Event|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
127192|NCT01466387|E3|Reported Event|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
127193|NCT01466387|E2|Reported Event|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
127194|NCT01466387|E1|Reported Event|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
127195|NCT01466361|B5|Baseline|Total|Total of all reporting groups
127196|NCT01466361|B4|Baseline|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127197|NCT01466361|B3|Baseline|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
127198|NCT01466361|B2|Baseline|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127199|NCT01466361|B1|Baseline|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
127200|NCT01466361|P4|Participant Flow|Placebo Lozenge (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127201|NCT01466361|P3|Participant Flow|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
127202|NCT01466361|P2|Participant Flow|Placebo Lozenge (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127203|NCT01466361|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
127204|NCT01466361|O4|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127205|NCT01466361|O3|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
127206|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127207|NCT01466361|O1|Outcome|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
127208|NCT01466361|O2|Outcome|Heavy Smokers Group|Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
127209|NCT01466361|O1|Outcome|Light Smokers Group|Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
127210|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127211|NCT01466361|O1|Outcome|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
127212|NCT01466361|O2|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
127213|NCT01466361|O1|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
127214|NCT01466361|E4|Reported Event|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127215|NCT01466361|E3|Reported Event|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
127216|NCT01466361|E2|Reported Event|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
127217|NCT01466361|E1|Reported Event|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
127218|NCT01466348|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
127219|NCT01466348|P2|Participant Flow|Paracetamol Powder Then Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.
127220|NCT01466348|P1|Participant Flow|Paracetamol/ Caffeine Tablet Then Paracetamol Powder|Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
127221|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127222|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127223|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127224|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127225|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127226|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
127227|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127228|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127229|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127230|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127231|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127232|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127233|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
128188|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
127234|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127235|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127236|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127237|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127238|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127239|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127240|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
127241|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127242|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127243|NCT01466348|E2|Reported Event|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
127244|NCT01466348|E1|Reported Event|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
127245|NCT01466270|B3|Baseline|Total|Total of all reporting groups
127246|NCT01466270|B2|Baseline|Arm II - Placebo|Patients receive placebo PO QD.
127247|NCT01466270|B1|Baseline|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127248|NCT01466270|P2|Participant Flow|Arm II - Placebo|Patients receive placebo PO QD.
127249|NCT01466270|P1|Participant Flow|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127250|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
127251|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127252|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
127253|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127254|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
127255|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127256|NCT01466270|O2|Outcome|Arm II|"Patients receive placebo PO QD.~Placebo: Given PO"
127257|NCT01466270|O1|Outcome|Arm I|"Patients receive donepezil hydrochloride PO QD.~donepezil hydrochloride: Given PO"
127258|NCT01466270|E2|Reported Event|Arm II - Placebo|Patients receive placebo PO QD.
127259|NCT01466270|E1|Reported Event|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
127260|NCT01466192|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
127261|NCT01466192|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
127262|NCT01466192|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
127263|NCT01466192|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
127264|NCT01466179|B1|Baseline|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127265|NCT01466179|P1|Participant Flow|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127266|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127267|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127268|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127269|NCT01466179|O3|Outcome|Cycle 2: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
127270|NCT01466179|O2|Outcome|Cycle 1: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
127271|NCT01466179|O1|Outcome|Cycle 1: Blinatumomab 9 μg/Day|Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
127272|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127394|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127273|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127274|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127275|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127276|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127277|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127278|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127279|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127280|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127281|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127282|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127283|NCT01466179|E1|Reported Event|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
127284|NCT01466075|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127285|NCT01466075|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127286|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127287|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127288|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127289|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127850|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127290|NCT01466075|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
127291|NCT01466062|B1|Baseline|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127292|NCT01466062|P1|Participant Flow|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127293|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127294|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127295|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127296|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127297|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127298|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127299|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127300|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127301|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127302|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127303|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127304|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127305|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127306|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127307|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127308|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127309|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127310|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127311|NCT01466062|E1|Reported Event|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
127312|NCT01465958|B1|Baseline|Safety Population|The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
127313|NCT01465958|P2|Participant Flow|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
127314|NCT01465958|P1|Participant Flow|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
127395|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127315|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
127316|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: Two intravenous infusions at a dose of 200-600 mg/kg per intravenous infusion every 3-4 weeks for 4 to 5 weeks.
127317|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
127318|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
127319|NCT01465958|E2|Reported Event|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
127320|NCT01465958|E1|Reported Event|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
127321|NCT01465802|B6|Baseline|Total|Total of all reporting groups
127322|NCT01465802|B5|Baseline|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127323|NCT01465802|B4|Baseline|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127324|NCT01465802|B3|Baseline|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127325|NCT01465802|B2|Baseline|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127326|NCT01465802|B1|Baseline|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127327|NCT01465802|P5|Participant Flow|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127328|NCT01465802|P4|Participant Flow|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127329|NCT01465802|P3|Participant Flow|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127330|NCT01465802|P2|Participant Flow|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127331|NCT01465802|P1|Participant Flow|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127332|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127351|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127851|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
127333|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127334|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127335|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127336|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127337|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127338|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127339|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127340|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127341|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127342|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127343|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127344|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127345|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127346|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127347|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127348|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127349|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127350|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127352|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127353|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127354|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127355|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127356|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127357|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127358|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127359|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127360|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127361|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127362|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127363|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127364|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127365|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127366|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127367|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127368|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127369|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127370|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127371|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127372|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127373|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127374|NCT01465802|E5|Reported Event|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
127375|NCT01465802|E4|Reported Event|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127376|NCT01465802|E3|Reported Event|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
127377|NCT01465802|E2|Reported Event|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127378|NCT01465802|E1|Reported Event|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
127379|NCT01465763|B4|Baseline|Total|Total of all reporting groups
127380|NCT01465763|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127381|NCT01465763|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127382|NCT01465763|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127383|NCT01465763|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127384|NCT01465763|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127385|NCT01465763|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127386|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127387|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127388|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127389|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127390|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127391|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127392|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127393|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
128189|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
127396|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127397|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127398|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127399|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127400|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127401|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127402|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127403|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127404|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127405|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127406|NCT01465763|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
127407|NCT01465763|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127408|NCT01465763|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
127409|NCT01465412|B5|Baseline|Total|Total of all reporting groups
127410|NCT01465412|B4|Baseline|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127411|NCT01465412|B3|Baseline|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127412|NCT01465412|B2|Baseline|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127413|NCT01465412|B1|Baseline|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127414|NCT01465412|P4|Participant Flow|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127415|NCT01465412|P3|Participant Flow|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127416|NCT01465412|P2|Participant Flow|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127417|NCT01465412|P1|Participant Flow|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127418|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127419|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127420|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127421|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127422|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127423|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127424|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127425|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127426|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127427|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127428|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127429|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127430|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
152245|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
127431|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127432|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127433|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127434|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127435|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127436|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127437|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127438|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127439|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127440|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127441|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127442|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127443|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127444|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127445|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127446|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127447|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127448|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127449|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127450|NCT01465412|E4|Reported Event|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
127451|NCT01465412|E3|Reported Event|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
127452|NCT01465412|E2|Reported Event|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127453|NCT01465412|E1|Reported Event|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
127454|NCT01465230|B1|Baseline|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
127455|NCT01465230|P1|Participant Flow|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
127456|NCT01465230|O1|Outcome|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
127457|NCT01465230|E1|Reported Event|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
127458|NCT01465178|B3|Baseline|Total|Total of all reporting groups
127459|NCT01465178|B2|Baseline|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
127460|NCT01465178|B1|Baseline|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
127461|NCT01465178|P2|Participant Flow|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
127462|NCT01465178|P1|Participant Flow|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
127463|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
127464|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
127465|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
127466|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
127467|NCT01465178|E2|Reported Event|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
127468|NCT01465178|E1|Reported Event|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
127469|NCT01465048|B4|Baseline|Total|Total of all reporting groups
127470|NCT01465048|B3|Baseline|PfSPZ Challenge 25,000 IM|
127471|NCT01465048|B2|Baseline|PfSPZ Challenge 2,500 IM|
127472|NCT01465048|B1|Baseline|PfSPZ Challenge 2,500 ID|
127473|NCT01465048|P3|Participant Flow|PfSPZ Challenge 25,000 IM|
127474|NCT01465048|P2|Participant Flow|PfSPZ Challenge 2,500 IM|
127475|NCT01465048|P1|Participant Flow|PfSPZ Challenge 2,500 ID|
127476|NCT01465048|O3|Outcome|PfSPZ Challenge 25,000 IM|
127477|NCT01465048|O2|Outcome|PfSPZ Challenge 2,500 IM|
127478|NCT01465048|O1|Outcome|PfSPZ Challenge 2,500 ID|
127479|NCT01465048|E3|Reported Event|PfSPZ Challenge 25,000 IM|
127480|NCT01465048|E2|Reported Event|PfSPZ Challenge 2,500 IM|
127481|NCT01465048|E1|Reported Event|PfSPZ Challenge 2,500 ID|
127482|NCT01465022|B4|Baseline|Total|Total of all reporting groups
127483|NCT01465022|B3|Baseline|Not Randomized|70 women who were enrolled.
127484|NCT01465022|B2|Baseline|Progestin-only Pill|Study Arm B is one of two interventions (POP).
127485|NCT01465022|B1|Baseline|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions (OCP).
127486|NCT01465022|P3|Participant Flow|Not Randomized|Participants who were consented but not randomized.
127487|NCT01465022|P2|Participant Flow|Progestin-only Pill|Study Arm B is one of two interventions.
127488|NCT01465022|P1|Participant Flow|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions.
127489|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127490|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127491|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127492|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127493|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127494|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127495|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127496|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127497|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127498|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127499|NCT01465022|E2|Reported Event|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
127500|NCT01465022|E1|Reported Event|Combined Estrogin-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
127501|NCT01464996|B1|Baseline|All Study Participants|Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
127502|NCT01464996|P1|Participant Flow|All Study Participants|"Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.~Participants were randomized to receive either type of intervention"
127503|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127504|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127505|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127506|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127507|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127508|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127509|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127546|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127510|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127511|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127512|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127513|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127514|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127515|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127516|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127517|NCT01464996|E2|Reported Event|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
127518|NCT01464996|E1|Reported Event|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
127519|NCT01464931|B3|Baseline|Total|Total of all reporting groups
127520|NCT01464931|B2|Baseline|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127521|NCT01464931|B1|Baseline|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127522|NCT01464931|P2|Participant Flow|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127523|NCT01464931|P1|Participant Flow|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127524|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127525|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127526|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127527|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127528|NCT01464931|O2|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
127529|NCT01464931|O1|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
127530|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
127531|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
127532|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
127533|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
127534|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
127535|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
127536|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
127537|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
127538|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
127539|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
127540|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127541|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127542|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127543|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127544|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127545|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127547|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127548|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127549|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127550|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127551|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127552|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127553|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127554|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127555|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127556|NCT01464931|E3|Reported Event|Denosumab 120 mg - All Subjects|Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127557|NCT01464931|E2|Reported Event|Denosumab 120 mg - ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127558|NCT01464931|E1|Reported Event|Denosumab 120 mg - Severe|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
127559|NCT01464840|B4|Baseline|Total|Total of all reporting groups
127560|NCT01464840|B3|Baseline|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127561|NCT01464840|B2|Baseline|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127562|NCT01464840|B1|Baseline|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127563|NCT01464840|P3|Participant Flow|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127564|NCT01464840|P2|Participant Flow|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127565|NCT01464840|P1|Participant Flow|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127566|NCT01464840|O3|Outcome|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127567|NCT01464840|O2|Outcome|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127568|NCT01464840|O1|Outcome|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127569|NCT01464840|E3|Reported Event|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127570|NCT01464840|E2|Reported Event|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127571|NCT01464840|E1|Reported Event|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
127572|NCT01464827|B15|Baseline|Total|Total of all reporting groups
127573|NCT01464827|B14|Baseline|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127574|NCT01464827|B13|Baseline|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127575|NCT01464827|B12|Baseline|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127576|NCT01464827|B11|Baseline|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127577|NCT01464827|B10|Baseline|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127578|NCT01464827|B9|Baseline|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127579|NCT01464827|B8|Baseline|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127580|NCT01464827|B7|Baseline|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127769|NCT01463878|B1|Baseline|Glycerna|Diabetic specific formula
127581|NCT01464827|B6|Baseline|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127582|NCT01464827|B5|Baseline|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
127583|NCT01464827|B4|Baseline|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127584|NCT01464827|B3|Baseline|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127585|NCT01464827|B2|Baseline|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127586|NCT01464827|B1|Baseline|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
127587|NCT01464827|P14|Participant Flow|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127588|NCT01464827|P13|Participant Flow|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127589|NCT01464827|P12|Participant Flow|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127590|NCT01464827|P11|Participant Flow|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127591|NCT01464827|P10|Participant Flow|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127592|NCT01464827|P9|Participant Flow|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127593|NCT01464827|P8|Participant Flow|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127594|NCT01464827|P7|Participant Flow|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127595|NCT01464827|P6|Participant Flow|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127596|NCT01464827|P5|Participant Flow|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
127597|NCT01464827|P4|Participant Flow|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127598|NCT01464827|P3|Participant Flow|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127599|NCT01464827|P2|Participant Flow|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127600|NCT01464827|P1|Participant Flow|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
127601|NCT01464827|O2|Outcome|Groups K + L + M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
127602|NCT01464827|O1|Outcome|Groups F + G + H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
127603|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127604|NCT01464827|O1|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
127605|NCT01464827|O3|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127606|NCT01464827|O2|Outcome|Groups C + D + J|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127607|NCT01464827|O1|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127608|NCT01464827|O3|Outcome|Groups H + I + M + N|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127609|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
152246|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
127610|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
127611|NCT01464827|O14|Outcome|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127612|NCT01464827|O13|Outcome|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127613|NCT01464827|O12|Outcome|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127614|NCT01464827|O11|Outcome|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127615|NCT01464827|O10|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127616|NCT01464827|O9|Outcome|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127617|NCT01464827|O8|Outcome|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127618|NCT01464827|O7|Outcome|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127619|NCT01464827|O6|Outcome|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127620|NCT01464827|O5|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
127621|NCT01464827|O4|Outcome|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127622|NCT01464827|O3|Outcome|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127623|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127624|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
127625|NCT01464827|O9|Outcome|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127626|NCT01464827|O8|Outcome|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127627|NCT01464827|O7|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127628|NCT01464827|O6|Outcome|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127629|NCT01464827|O5|Outcome|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127630|NCT01464827|O4|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
127631|NCT01464827|O3|Outcome|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127632|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127633|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
127634|NCT01464827|E9|Reported Event|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127635|NCT01464827|E8|Reported Event|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127636|NCT01464827|E7|Reported Event|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127637|NCT01464827|E6|Reported Event|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
127638|NCT01464827|E5|Reported Event|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
128190|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
127639|NCT01464827|E4|Reported Event|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
127640|NCT01464827|E3|Reported Event|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
127641|NCT01464827|E2|Reported Event|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
127642|NCT01464827|E1|Reported Event|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
127643|NCT01464619|B3|Baseline|Total|Total of all reporting groups
127644|NCT01464619|B2|Baseline|Intervention|"Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.~The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials."
127645|NCT01464619|B1|Baseline|Delayed Intervention|"Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.~Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment."
127646|NCT01464619|P2|Participant Flow|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127647|NCT01464619|P1|Participant Flow|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127648|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127649|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127650|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127651|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127652|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127653|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127654|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127655|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127656|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
127657|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
127658|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127659|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127660|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
127661|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
127662|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127663|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
127664|NCT01464619|E2|Reported Event|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
127665|NCT01464619|E1|Reported Event|Intervention|Subjects received parenting intervention immediately
127666|NCT01464424|B1|Baseline|Overall|Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
127770|NCT01463878|P2|Participant Flow|Control - Jevity|The control arm of the study. Patients to receive Jevity
127667|NCT01464424|P2|Participant Flow|LUMIGAN, Then TRAVATAN|Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
127668|NCT01464424|P1|Participant Flow|TRAVATAN, Then LUMIGAN|Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
127669|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127670|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127671|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127672|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127673|NCT01464424|E2|Reported Event|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127674|NCT01464424|E1|Reported Event|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
127675|NCT01464359|B1|Baseline|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
127676|NCT01464359|P1|Participant Flow|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
127677|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
127678|NCT01464359|E1|Reported Event|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
127679|NCT01464307|B3|Baseline|Total|Total of all reporting groups
127680|NCT01464307|B2|Baseline|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127681|NCT01464307|B1|Baseline|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127682|NCT01464307|P2|Participant Flow|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127683|NCT01464307|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127771|NCT01463878|P1|Participant Flow|Glycerna|Diabetic specific formula
127684|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127685|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127686|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127687|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127688|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127689|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127690|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127691|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127692|NCT01464307|E3|Reported Event|Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127693|NCT01464307|E2|Reported Event|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
127694|NCT01464307|E1|Reported Event|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
127695|NCT01464255|B3|Baseline|Total|Total of all reporting groups
127696|NCT01464255|B2|Baseline|Ocufilcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
127697|NCT01464255|B1|Baseline|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
127698|NCT01464255|P2|Participant Flow|Ocufulcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
127699|NCT01464255|P1|Participant Flow|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
127700|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127701|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127702|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127703|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127704|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127705|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127706|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127707|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127708|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127709|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127710|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127711|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127712|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127713|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127714|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127715|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127716|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127717|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127718|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
127719|NCT01464255|E2|Reported Event|Ocufilcon B|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127720|NCT01464255|E1|Reported Event|Ocufilcon D|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
127721|NCT01464190|B3|Baseline|Total|Total of all reporting groups
127722|NCT01464190|B2|Baseline|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127723|NCT01464190|B1|Baseline|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
127724|NCT01464190|P2|Participant Flow|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127725|NCT01464190|P1|Participant Flow|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
127726|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127727|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
127728|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127729|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
127730|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127731|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
127732|NCT01464190|E2|Reported Event|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
127733|NCT01464190|E1|Reported Event|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
127734|NCT01464021|B1|Baseline|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127735|NCT01464021|P1|Participant Flow|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127736|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127737|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127738|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127739|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127740|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127741|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
152247|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
127742|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127743|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127744|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127745|NCT01464021|E1|Reported Event|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
127746|NCT01463982|B5|Baseline|Total|Total of all reporting groups
127747|NCT01463982|B4|Baseline|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127748|NCT01463982|B3|Baseline|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127749|NCT01463982|B2|Baseline|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127750|NCT01463982|B1|Baseline|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127751|NCT01463982|P4|Participant Flow|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127752|NCT01463982|P3|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127753|NCT01463982|P2|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127754|NCT01463982|P1|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127755|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127756|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127757|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127758|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127759|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127760|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127761|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127762|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127763|NCT01463982|E4|Reported Event|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127764|NCT01463982|E3|Reported Event|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127765|NCT01463982|E2|Reported Event|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127766|NCT01463982|E1|Reported Event|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
127767|NCT01463878|B3|Baseline|Total|Total of all reporting groups
127768|NCT01463878|B2|Baseline|Control - Jevity|The control arm of the study. Patients to receive Jevity
127777|NCT01463696|B8|Baseline|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127778|NCT01463696|B7|Baseline|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127779|NCT01463696|B6|Baseline|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127780|NCT01463696|B5|Baseline|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127781|NCT01463696|B4|Baseline|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127782|NCT01463696|B3|Baseline|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127783|NCT01463696|B2|Baseline|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127784|NCT01463696|B1|Baseline|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127785|NCT01463696|P8|Participant Flow|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127786|NCT01463696|P7|Participant Flow|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127787|NCT01463696|P6|Participant Flow|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127788|NCT01463696|P5|Participant Flow|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127789|NCT01463696|P4|Participant Flow|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127790|NCT01463696|P3|Participant Flow|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127791|NCT01463696|P2|Participant Flow|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127792|NCT01463696|P1|Participant Flow|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127793|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127794|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127795|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127796|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127797|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127798|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127847|NCT01463683|P1|Participant Flow|V232-2XP Subcutaneous (SC)|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127799|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127800|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127801|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127802|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127803|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127804|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127805|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127806|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127807|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127808|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127809|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127810|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127811|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127812|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127813|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127814|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127815|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127816|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127817|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127818|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127819|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127820|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127848|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
127849|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127821|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127822|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127823|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127824|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127825|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127826|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127827|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127828|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127829|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127830|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127831|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127832|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127833|NCT01463696|E8|Reported Event|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
127834|NCT01463696|E7|Reported Event|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
127835|NCT01463696|E6|Reported Event|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
127836|NCT01463696|E5|Reported Event|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
127837|NCT01463696|E4|Reported Event|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
127838|NCT01463696|E3|Reported Event|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
127839|NCT01463696|E2|Reported Event|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
127840|NCT01463696|E1|Reported Event|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
127841|NCT01463683|B4|Baseline|Total|Total of all reporting groups
127842|NCT01463683|B3|Baseline|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
127843|NCT01463683|B2|Baseline|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127844|NCT01463683|B1|Baseline|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127845|NCT01463683|P3|Participant Flow|V232-2XP Intramuscular (IM)|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
127846|NCT01463683|P2|Participant Flow|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127852|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127853|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127854|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127855|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127856|NCT01463683|E3|Reported Event|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
127857|NCT01463683|E2|Reported Event|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127858|NCT01463683|E1|Reported Event|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
127859|NCT01463527|B3|Baseline|Total|Total of all reporting groups
127860|NCT01463527|B2|Baseline|Capnography Blind|Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
127861|NCT01463527|B1|Baseline|Open Capnography|Staff members able to view capnography monitor during sedation.
127862|NCT01463527|P2|Participant Flow|Capnography Blind|Staff members blinded to capnography screen and alarms turned off during sedation.
127863|NCT01463527|P1|Participant Flow|Open Capnography|Staff members able to view capnography monitor during sedation.
127864|NCT01463527|O2|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
127865|NCT01463527|O1|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
127866|NCT01463527|E2|Reported Event|Capnography Blind|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
127867|NCT01463527|E1|Reported Event|Open Capnography|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
127868|NCT01463384|B1|Baseline|Minocycline|Subjects administered 50mg minocycline twice daily for 6 months
127869|NCT01463384|P1|Participant Flow|Minocycline|Subjects were administered 50mg minocycline twice daily for 6 months
127870|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
127871|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
127872|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
127873|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
127874|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
127875|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
127876|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
127877|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
127878|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
127879|NCT01463384|E1|Reported Event|Minocycline|No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
127880|NCT01463293|B4|Baseline|Total|Total of all reporting groups
127881|NCT01463293|B3|Baseline|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
127882|NCT01463293|B2|Baseline|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
127883|NCT01463293|B1|Baseline|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
127884|NCT01463293|P3|Participant Flow|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
127885|NCT01463293|P2|Participant Flow|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
127886|NCT01463293|P1|Participant Flow|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
127887|NCT01463293|O3|Outcome|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
127888|NCT01463293|O2|Outcome|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
127889|NCT01463293|O1|Outcome|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
127890|NCT01463293|E3|Reported Event|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
127891|NCT01463293|E2|Reported Event|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
127892|NCT01463293|E1|Reported Event|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
127893|NCT01463033|B3|Baseline|Total|Total of all reporting groups
127894|NCT01463033|B2|Baseline|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127895|NCT01463033|B1|Baseline|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127896|NCT01463033|P2|Participant Flow|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127897|NCT01463033|P1|Participant Flow|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127898|NCT01463033|O1|Outcome|Participants|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
127899|NCT01463033|O2|Outcome|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127900|NCT01463033|O1|Outcome|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
127901|NCT01463033|E2|Reported Event|Observational|Adverse events were not monitored for the Observational group
127902|NCT01463033|E1|Reported Event|Levetiracetam|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
127903|NCT01463007|B1|Baseline|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
127904|NCT01463007|P1|Participant Flow|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
127905|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
127906|NCT01463007|O2|Outcome|Extended to 5 Years of Follow Up-Rhode Island Hospital Only|Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
127907|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
127908|NCT01463007|E1|Reported Event|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
127909|NCT01462942|B6|Baseline|Total|Total of all reporting groups
127910|NCT01462942|B5|Baseline|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127911|NCT01462942|B4|Baseline|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127912|NCT01462942|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127913|NCT01462942|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127914|NCT01462942|B1|Baseline|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127915|NCT01462942|P5|Participant Flow|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127916|NCT01462942|P4|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127917|NCT01462942|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127918|NCT01462942|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127919|NCT01462942|P1|Participant Flow|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127920|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127921|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127922|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127923|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127924|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127925|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127926|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127927|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127928|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127929|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127930|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127931|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127932|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127933|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
128191|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
127934|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127935|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127936|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127937|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127938|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127939|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
127940|NCT01462942|E5|Reported Event|Formoterol 12 μg|
127941|NCT01462942|E4|Reported Event|Aclidinium 400 μg|
127942|NCT01462942|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|
127943|NCT01462942|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|
127944|NCT01462942|E1|Reported Event|Placebo|
127945|NCT01462929|B4|Baseline|Total|Total of all reporting groups
127946|NCT01462929|B3|Baseline|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
127947|NCT01462929|B2|Baseline|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
127948|NCT01462929|B1|Baseline|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
127949|NCT01462929|P3|Participant Flow|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
127950|NCT01462929|P2|Participant Flow|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
127951|NCT01462929|P1|Participant Flow|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
127952|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
127953|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
127954|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
127955|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
127956|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
127957|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
127958|NCT01462929|E3|Reported Event|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
127959|NCT01462929|E2|Reported Event|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
128058|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
127960|NCT01462929|E1|Reported Event|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
127961|NCT01462877|B1|Baseline|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127962|NCT01462877|P1|Participant Flow|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127963|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127964|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127965|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127966|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127967|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127968|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127969|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127970|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127971|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127972|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127973|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127974|NCT01462877|E1|Reported Event|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
127975|NCT01462812|B3|Baseline|Total|Total of all reporting groups
127976|NCT01462812|B2|Baseline|Sumatriptan|Sumatriptan : Sumatriptan 20mg
127977|NCT01462812|B1|Baseline|Matching Placebo|Placebo : Matching placebo
127978|NCT01462812|P2|Participant Flow|Sumatriptan|Sumatriptan : Sumatriptan 20mg
127979|NCT01462812|P1|Participant Flow|Matching Placebo|Placebo : Matching placebo
127980|NCT01462812|O2|Outcome|Sumatriptan|Sumatriptan : Sumatriptan 20mg
127981|NCT01462812|O1|Outcome|Matching Placebo|Placebo : Matching placebo
127982|NCT01462812|E2|Reported Event|Sumatriptan|Sumatriptan : Sumatriptan 20mg
127983|NCT01462812|E1|Reported Event|Matching Placebo|Placebo : Matching placebo
127984|NCT01462773|B1|Baseline|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
127985|NCT01462773|P1|Participant Flow|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
127986|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
127987|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Patients were treated on a 5-week cycle. Week 1 of cycle 1, patients received 5 million U/m(2) IFN-a subcutaneously thrice weekly. Weeks 2-4 of cycle 1, bortezomib was administered intravenously weely along with IFN-a thrice weekly. A break from treatment during week 5. Folllowing cycle 1, bortezomib was administered in combination iwth IFN-a. Bortezomib was administered in escalating doses to cohorts of 3 patients.
127988|NCT01462773|E1|Reported Event|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients were treated on a 5-week cycle. In week 1 of cycle 1, patients received 5 million U/m(2) IFN-α subcutaneously thrice weekly. During weeks 2-4 of cycle 1, bortezomib was administered intravenously weekly along with IFN-α thrice weekly. There was a treatment break during week 5. After cycle 1, bortezomib was administered in combination with IFN-α. Bortezomib was administered in escalating doses (1.0, 1.3, or 1.6 mg/m) to cohorts of 3 patients.
127989|NCT01462695|B3|Baseline|Total|Total of all reporting groups
127990|NCT01462695|B2|Baseline|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127991|NCT01462695|B1|Baseline|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127992|NCT01462695|P2|Participant Flow|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127993|NCT01462695|P1|Participant Flow|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127994|NCT01462695|O2|Outcome|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127995|NCT01462695|O1|Outcome|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127996|NCT01462695|E2|Reported Event|Stratum B: Recurrent Ependymoma|Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
128059|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
127997|NCT01462695|E1|Reported Event|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
127998|NCT01462435|B5|Baseline|Total|Total of all reporting groups
127999|NCT01462435|B4|Baseline|Placebo|Placebo : Capsules
128000|NCT01462435|B3|Baseline|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128001|NCT01462435|B2|Baseline|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128002|NCT01462435|B1|Baseline|Celecoxib|Celecoxib : 200 mg Capsules
128003|NCT01462435|P4|Participant Flow|Placebo|Placebo : Capsules
128004|NCT01462435|P3|Participant Flow|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128005|NCT01462435|P2|Participant Flow|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128006|NCT01462435|P1|Participant Flow|Celecoxib|Celecoxib : 200 mg Capsules
128007|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128008|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128009|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128010|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128011|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128012|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128013|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128014|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128015|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128016|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128017|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128018|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128019|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128020|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128021|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128022|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128023|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128024|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128025|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128026|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128027|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128028|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128029|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128030|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128031|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128032|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128033|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128034|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128035|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
128036|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128037|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128038|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
128039|NCT01462435|E4|Reported Event|Placebo|Placebo : Capsules
128040|NCT01462435|E3|Reported Event|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
128041|NCT01462435|E2|Reported Event|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
128042|NCT01462435|E1|Reported Event|Celecoxib|Celecoxib : 200 mg Capsules
128043|NCT01462370|B1|Baseline|All Randomized Participants|All participants randomized into the study.
128044|NCT01462370|P2|Participant Flow|Ibuprofen Up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
128045|NCT01462370|P1|Participant Flow|Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg|Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
128046|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128047|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128048|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128049|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128050|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128051|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128052|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128053|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128054|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128055|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128056|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128057|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128060|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128061|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128062|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128063|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128064|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128065|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128066|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128067|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128068|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128069|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128070|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128071|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128072|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
128073|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
128074|NCT01462370|E2|Reported Event|Ibuprofen up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to four times a day as needed, for a maximum of 2400 mg/day in menstrual cycle 1. In menstrual cycle 2, etoricoxib was administered at a dose of 120 mg daily.
128075|NCT01462370|E1|Reported Event|Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily|Etoricoxib 120 mg tablet given orally for one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
128076|NCT01462357|B4|Baseline|Total|Total of all reporting groups
128077|NCT01462357|B3|Baseline|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128078|NCT01462357|B2|Baseline|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128079|NCT01462357|B1|Baseline|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128080|NCT01462357|P3|Participant Flow|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128081|NCT01462357|P2|Participant Flow|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128082|NCT01462357|P1|Participant Flow|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128083|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128084|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128085|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128086|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128087|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128088|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128089|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128090|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128091|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128092|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128093|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128180|NCT01462266|B2|Baseline|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
128181|NCT01462266|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
128094|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128095|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128096|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128097|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128098|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128099|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128100|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128101|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128102|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128103|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128104|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128105|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128106|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128107|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128108|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128109|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128110|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128111|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128112|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128113|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128114|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128115|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128116|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128117|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128118|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128119|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128120|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128121|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128182|NCT01462266|P2|Participant Flow|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
128122|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128123|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128124|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128125|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128126|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128127|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128128|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128129|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128130|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128131|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128132|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128133|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128134|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128135|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128136|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128137|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128138|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128139|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128140|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128141|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128142|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128143|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128144|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128145|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128146|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128147|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128148|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128149|NCT01462357|E3|Reported Event|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128183|NCT01462266|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
128150|NCT01462357|E2|Reported Event|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128151|NCT01462357|E1|Reported Event|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
128152|NCT01462344|B3|Baseline|Total|Total of all reporting groups
128153|NCT01462344|B2|Baseline|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128154|NCT01462344|B1|Baseline|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128155|NCT01462344|P2|Participant Flow|Fluticasone Propionate (FP)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128156|NCT01462344|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128157|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128158|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128159|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128160|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128161|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128162|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128163|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128184|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
128185|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
128164|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128165|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128166|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128167|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128168|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128169|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128170|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128171|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128172|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128173|NCT01462344|E2|Reported Event|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
128174|NCT01462344|E1|Reported Event|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
128175|NCT01462279|B1|Baseline|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
128176|NCT01462279|P1|Participant Flow|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
128177|NCT01462279|O1|Outcome|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
128178|NCT01462279|E1|Reported Event|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
128179|NCT01462266|B3|Baseline|Total|Total of all reporting groups
152248|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
128192|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
128193|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
128194|NCT01462266|E2|Reported Event|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
128195|NCT01462266|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
128196|NCT01462227|B3|Baseline|Total|Total of all reporting groups
128197|NCT01462227|B2|Baseline|Naltrexone (Higher Dose)|Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
128198|NCT01462227|B1|Baseline|Naltrexone (Lower Dose)|Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
128199|NCT01462227|P4|Participant Flow|Placebo First / Naltrexone (Higher Dose) Second|Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
128200|NCT01462227|P3|Participant Flow|Naltrexone (Higher Dose) First /Placebo Second|Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
128201|NCT01462227|P2|Participant Flow|Placebo First/ Naltrexone (Lower Dose) Second|Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
128202|NCT01462227|P1|Participant Flow|Naltrexone (Lower Dose) First /Placebo Second|Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
128203|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128204|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128205|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128206|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128207|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128208|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128209|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128210|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128211|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128212|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128213|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128214|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
128215|NCT01462227|E4|Reported Event|Placebo (Higher Dose)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
128216|NCT01462227|E3|Reported Event|Naltrexone (100 mg)|Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
128217|NCT01462227|E2|Reported Event|Placebo (Lower Dose Group)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
128218|NCT01462227|E1|Reported Event|Naltrexone (50 mg)|Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
128219|NCT01462162|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
128220|NCT01462162|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
128221|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128222|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128223|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128224|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128454|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128225|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128226|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128227|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128228|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128229|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128230|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128231|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128232|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128233|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128234|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128235|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128236|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128237|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128238|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128239|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128240|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128241|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128242|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
128243|NCT01462162|E1|Reported Event|All Participants|Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
128244|NCT01462045|B4|Baseline|Total|Total of all reporting groups
128245|NCT01462045|B3|Baseline|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
128246|NCT01462045|B2|Baseline|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
128247|NCT01462045|B1|Baseline|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
128248|NCT01462045|P3|Participant Flow|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
128249|NCT01462045|P2|Participant Flow|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
128250|NCT01462045|P1|Participant Flow|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
128251|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
128252|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
128253|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
128254|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
128255|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
128256|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
128257|NCT01462045|E3|Reported Event|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
128258|NCT01462045|E2|Reported Event|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
128259|NCT01462045|E1|Reported Event|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
128260|NCT01461993|B4|Baseline|Total|Total of all reporting groups
128261|NCT01461993|B3|Baseline|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128262|NCT01461993|B2|Baseline|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128263|NCT01461993|B1|Baseline|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128264|NCT01461993|P3|Participant Flow|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128265|NCT01461993|P2|Participant Flow|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128266|NCT01461993|P1|Participant Flow|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128267|NCT01461993|O3|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128268|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128269|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128270|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128271|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128272|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128273|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128274|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128275|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128276|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128277|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128278|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128279|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128280|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128281|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128282|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128283|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128284|NCT01461993|E3|Reported Event|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128285|NCT01461993|E2|Reported Event|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
128286|NCT01461993|E1|Reported Event|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
128287|NCT01461980|B4|Baseline|Total|Total of all reporting groups
128288|NCT01461980|B3|Baseline|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128289|NCT01461980|B2|Baseline|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128290|NCT01461980|B1|Baseline|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128291|NCT01461980|P3|Participant Flow|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128292|NCT01461980|P2|Participant Flow|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128293|NCT01461980|P1|Participant Flow|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128294|NCT01461980|O3|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128295|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128296|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128297|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128298|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128299|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128300|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128301|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128302|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128303|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128304|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128305|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128306|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128307|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128308|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128309|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128310|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128311|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128312|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128313|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128314|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128315|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128316|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128317|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128318|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128319|NCT01461980|E3|Reported Event|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
128320|NCT01461980|E2|Reported Event|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
128401|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128455|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128321|NCT01461980|E1|Reported Event|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
128322|NCT01461811|B3|Baseline|Total|Total of all reporting groups
128323|NCT01461811|B2|Baseline|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128324|NCT01461811|B1|Baseline|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128325|NCT01461811|P2|Participant Flow|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128326|NCT01461811|P1|Participant Flow|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128327|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128328|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128329|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128330|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128331|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128332|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128333|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128334|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128335|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128336|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128337|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128338|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128339|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128340|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128341|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128342|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128343|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128344|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128345|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128346|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128347|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128348|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128349|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128350|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128351|NCT01461811|E2|Reported Event|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
128352|NCT01461811|E1|Reported Event|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
128353|NCT01461733|B3|Baseline|Total|Total of all reporting groups
128354|NCT01461733|B2|Baseline|Placebo|Placebo: placebo delivered blinded
128355|NCT01461733|B1|Baseline|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
128356|NCT01461733|P2|Participant Flow|Placebo|
128357|NCT01461733|P1|Participant Flow|Amiodarone|standard dose amiodarone
128358|NCT01461733|O2|Outcome|Placebo|Placebo: placebo delivered blinded
128359|NCT01461733|O1|Outcome|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
128360|NCT01461733|E2|Reported Event|Placebo|Placebo: placebo delivered blinded
128361|NCT01461733|E1|Reported Event|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
128362|NCT01461655|B1|Baseline|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128452|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128453|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128363|NCT01461655|P1|Participant Flow|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.~The randomised subjects received the following products:~NSAID 5% gel , in the morning on the appropriate hemiface.~Topical retinoid 0.1% gel, in the evening on the entire face.~Vehicle gel, in the morning on the appropriate hemiface."
128364|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128365|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128366|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128367|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128368|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128369|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128370|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128371|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128372|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128373|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128374|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128375|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128376|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
128377|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
128378|NCT01461655|E1|Reported Event|Topical Retinoid - Placebo, Topical Retinoid - NSAID|
128379|NCT01461551|B4|Baseline|Total|Total of all reporting groups
128380|NCT01461551|B3|Baseline|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
128381|NCT01461551|B2|Baseline|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
128382|NCT01461551|B1|Baseline|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
128383|NCT01461551|P3|Participant Flow|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
128384|NCT01461551|P2|Participant Flow|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
128385|NCT01461551|P1|Participant Flow|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
128386|NCT01461551|O3|Outcome|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
128387|NCT01461551|O2|Outcome|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
128388|NCT01461551|O1|Outcome|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
128389|NCT01461551|E3|Reported Event|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
128390|NCT01461551|E2|Reported Event|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
128391|NCT01461551|E1|Reported Event|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
128392|NCT01461538|B4|Baseline|Total|Total of all reporting groups
128393|NCT01461538|B3|Baseline|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128394|NCT01461538|B2|Baseline|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128395|NCT01461538|B1|Baseline|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128396|NCT01461538|P3|Participant Flow|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128397|NCT01461538|P2|Participant Flow|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128398|NCT01461538|P1|Participant Flow|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128399|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128400|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128402|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128403|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128404|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128405|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128406|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128407|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128408|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128409|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128410|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128411|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128412|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128413|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128414|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128415|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128416|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128417|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128418|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128419|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128420|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
128421|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
128422|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
128423|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
128424|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
128425|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
128426|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
128427|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
128428|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
128429|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
128430|NCT01461538|E3|Reported Event|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
128431|NCT01461538|E2|Reported Event|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128432|NCT01461538|E1|Reported Event|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
128433|NCT01461369|B4|Baseline|Total|Total of all reporting groups
128434|NCT01461369|B3|Baseline|Placebo|Placebo: Capsule
128435|NCT01461369|B2|Baseline|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128436|NCT01461369|B1|Baseline|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128437|NCT01461369|P3|Participant Flow|Placebo|Placebo: Capsule
128438|NCT01461369|P2|Participant Flow|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128439|NCT01461369|P1|Participant Flow|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128440|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128441|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128442|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128443|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128444|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128445|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128446|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128447|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128448|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128449|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
128450|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128451|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128456|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
128457|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
128458|NCT01461369|E3|Reported Event|Placebo|Placebo: Capsule
128459|NCT01461369|E2|Reported Event|Diclofenac 35 mg Three Times Daily|Diclofenac Test (three times daily): Capsules
128460|NCT01461369|E1|Reported Event|Diclofenac 35 mg Two Times Daily|Diclofenac Test (two times daily): Capsules
128461|NCT01461096|B3|Baseline|Total|Total of all reporting groups
128462|NCT01461096|B2|Baseline|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128463|NCT01461096|B1|Baseline|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128464|NCT01461096|P2|Participant Flow|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128465|NCT01461096|P1|Participant Flow|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128466|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128467|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128468|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128469|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128470|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128471|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128472|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128473|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128474|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128475|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128476|NCT01461096|E2|Reported Event|Placebo|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128477|NCT01461096|E1|Reported Event|qHPV|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
128478|NCT01461057|B3|Baseline|Total|Total of all reporting groups
128603|NCT01460446|O1|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
129007|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
128479|NCT01461057|B2|Baseline|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
128480|NCT01461057|B1|Baseline|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
128481|NCT01461057|P2|Participant Flow|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
128482|NCT01461057|P1|Participant Flow|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
128483|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
128484|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
128485|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
128486|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
128487|NCT01461057|E2|Reported Event|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
128488|NCT01461057|E1|Reported Event|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
128489|NCT01461044|B3|Baseline|Total|Total of all reporting groups
128490|NCT01461044|B2|Baseline|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128491|NCT01461044|B1|Baseline|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128610|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128492|NCT01461044|P2|Participant Flow|Bevacizumab: Triple Negative (TN) Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128493|NCT01461044|P1|Participant Flow|Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer|Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128494|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128495|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128496|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128497|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128498|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128499|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128500|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128501|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128502|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128503|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128604|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128504|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128505|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128506|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128507|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128508|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128509|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128510|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128511|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128512|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128513|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128514|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128515|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128605|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128516|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128517|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128518|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128519|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128520|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
128521|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128522|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128523|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128524|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128525|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128526|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128527|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128606|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
129008|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
128528|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128529|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128530|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128531|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128532|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128533|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128534|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128535|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128536|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128537|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128538|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128539|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128607|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128540|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128541|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128542|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128543|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128544|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128545|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128546|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128547|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128548|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128549|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128550|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128551|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128552|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128739|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128553|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128554|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128555|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128556|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128557|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128558|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128559|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128560|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128561|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128562|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128563|NCT01461044|E2|Reported Event|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128564|NCT01461044|E1|Reported Event|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
128565|NCT01460927|B1|Baseline|TriActive+ RF|Healthy male or female subjects 30-60 years of age, having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
128608|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128609|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
129009|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
128566|NCT01460927|P1|Participant Flow|TriActive+RF|"Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject’s tolerability and reaction of the tissue.~The power is adjusted to suit the subject’s sensitivity and the “depth” of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature.~The temperature of 43°C should be maintained at the end point for several minutes (3-5min)."
128567|NCT01460927|O5|Outcome|3 Month FU|3 Months after the 8th treatment
128568|NCT01460927|O4|Outcome|1 Month FU|1 Month after the 8th treatment
128569|NCT01460927|O3|Outcome|Pre Treatment 8|After 7 treatments
128570|NCT01460927|O2|Outcome|Pre Treatment 4|After 3 treatments
128571|NCT01460927|O1|Outcome|Baseline|Baseline (before Treatments)
128572|NCT01460927|E1|Reported Event|TriActive+RF|Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
128573|NCT01460732|B1|Baseline|All Patients|All patients analyzed
128574|NCT01460732|P1|Participant Flow|All Patients|All patients analyzed
128575|NCT01460732|O2|Outcome|HBPM-Nocturnal|Dippers defined by HBPM-Nocturnal.
128576|NCT01460732|O1|Outcome|ABPM|Dippers defined by ABPM.
128577|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128578|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128579|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128580|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128581|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128582|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128583|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128584|NCT01460732|O1|Outcome|All Patients|All patients analyzed
128585|NCT01460732|E1|Reported Event|All Patients|All patients analyzed
128586|NCT01460446|B3|Baseline|Total|Total of all reporting groups
128587|NCT01460446|B2|Baseline|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128588|NCT01460446|B1|Baseline|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128589|NCT01460446|P2|Participant Flow|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128590|NCT01460446|P1|Participant Flow|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128591|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128592|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128593|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128594|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128595|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128596|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128597|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128598|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128599|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128600|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128601|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128602|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
129010|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
128611|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128612|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128613|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128614|NCT01460446|E2|Reported Event|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128615|NCT01460446|E1|Reported Event|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
128616|NCT01460342|B3|Baseline|Total|Total of all reporting groups
128617|NCT01460342|B2|Baseline|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128618|NCT01460342|B1|Baseline|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128619|NCT01460342|P2|Participant Flow|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128620|NCT01460342|P1|Participant Flow|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128621|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128622|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128623|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128624|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128625|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128626|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128627|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128628|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128629|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128630|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128631|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128632|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128633|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128634|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128635|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128636|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128637|NCT01460342|E2|Reported Event|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
128638|NCT01460342|E1|Reported Event|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
128639|NCT01460290|B1|Baseline|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study."
128640|NCT01460290|P1|Participant Flow|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
128641|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128642|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128643|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128644|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128645|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128646|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128647|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128648|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128649|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128650|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128651|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128652|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128653|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128654|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128655|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
128656|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
128657|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
128658|NCT01460290|E1|Reported Event|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
128659|NCT01459913|B5|Baseline|Total|Total of all reporting groups
128660|NCT01459913|B4|Baseline|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
128661|NCT01459913|B3|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
128662|NCT01459913|B2|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128663|NCT01459913|B1|Baseline|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128664|NCT01459913|P4|Participant Flow|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
128665|NCT01459913|P3|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
128666|NCT01459913|P2|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128667|NCT01459913|P1|Participant Flow|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
128668|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
128669|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
128670|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128740|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
129011|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
128671|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128672|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128673|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128674|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128675|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128676|NCT01459913|O5|Outcome|Telaprevir+Peg-IFN-alfa-2a, RBV (Total)|All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
128677|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
128678|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
128679|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128680|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128681|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128682|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128683|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128684|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128741|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
152249|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
128685|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128686|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128687|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128688|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128689|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128690|NCT01459913|O1|Outcome|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128691|NCT01459913|E4|Reported Event|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
128692|NCT01459913|E3|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
128693|NCT01459913|E2|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
128694|NCT01459913|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
128695|NCT01459783|B3|Baseline|Total|Total of all reporting groups
128696|NCT01459783|B2|Baseline|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
128697|NCT01459783|B1|Baseline|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
129012|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
128698|NCT01459783|P2|Participant Flow|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
128699|NCT01459783|P1|Participant Flow|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
128700|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
128701|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
128702|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
128703|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
128704|NCT01459783|E2|Reported Event|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
128742|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128743|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128705|NCT01459783|E1|Reported Event|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
128706|NCT01459705|B4|Baseline|Total|Total of all reporting groups
128707|NCT01459705|B3|Baseline|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128708|NCT01459705|B2|Baseline|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128709|NCT01459705|B1|Baseline|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128710|NCT01459705|P3|Participant Flow|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128711|NCT01459705|P2|Participant Flow|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128712|NCT01459705|P1|Participant Flow|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128713|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128714|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128715|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128716|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128717|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128718|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128744|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
130505|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
128719|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128720|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128721|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128722|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128723|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128724|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128725|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128726|NCT01459705|E3|Reported Event|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
128727|NCT01459705|E2|Reported Event|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
128728|NCT01459705|E1|Reported Event|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
128729|NCT01459653|B1|Baseline|EP2006, Evaluable Sample|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
128730|NCT01459653|P1|Participant Flow|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128731|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
128732|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128733|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128734|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128735|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
128736|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128737|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128738|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128745|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128746|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128747|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128748|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128749|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128750|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128751|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128752|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128753|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128754|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128755|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128756|NCT01459653|O3|Outcome|EP2006: Over Treated|Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128757|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128758|NCT01459653|O1|Outcome|EP2006: Undertreated|Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128759|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
128760|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
128761|NCT01459653|O2|Outcome|EP2006: No CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
128762|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance
128763|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
128764|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN
128765|NCT01459653|O2|Outcome|EP2006: no CIN/FN-related Chemotherapy Disturbance|Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128766|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128767|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128768|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128769|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128770|NCT01459653|O3|Outcome|EP2006: >=6 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
128771|NCT01459653|O2|Outcome|EP2006: 4-5 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
128772|NCT01459653|O1|Outcome|EP2006: 1-3 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
128773|NCT01459653|O3|Outcome|EP2006: Day 4 or Later|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
128774|NCT01459653|O2|Outcome|EP2006: Days 1-3 (Per Guidelines)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
128775|NCT01459653|O1|Outcome|EP2006: Day 0 (During Chemotherapy)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
128776|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128777|NCT01459653|O3|Outcome|EP2006: Mean GIS 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
128778|NCT01459653|O2|Outcome|EP2006: Mean GIS 0.51-0.99|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
128779|NCT01459653|O1|Outcome|EP2006: Mean GIS 0-0.5|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
128780|NCT01459653|O2|Outcome|EP2006: 48MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
128781|NCT01459653|O1|Outcome|EP2006: 30MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
128782|NCT01459653|O3|Outcome|EP2006: Overtreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
128783|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
128784|NCT01459653|O1|Outcome|EP2006: Undertreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
128785|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
128786|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN
128787|NCT01459653|O3|Outcome|EP2006: High (>20%) Risk|Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128788|NCT01459653|O2|Outcome|EP2006: Medium (10-20%) Risk|Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128789|NCT01459653|O1|Outcome|EP2006: Low (<10%) Risk|Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128790|NCT01459653|O1|Outcome|EP2006 Cycle Level|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128791|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128792|NCT01459653|O1|Outcome|EP2006 Cycles|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128793|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128794|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128795|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128796|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128797|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128798|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128799|NCT01459653|O3|Outcome|EP2006: EP2006 Initiation Later (Day 4 or More)^|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
128800|NCT01459653|O2|Outcome|EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
128801|NCT01459653|O1|Outcome|EP2006: EP2006 Initiation During Chemotherapy (Day 0)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
128802|NCT01459653|O3|Outcome|EP2006: Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128803|NCT01459653|O2|Outcome|EP2006: Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128804|NCT01459653|O1|Outcome|EP2006: All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128805|NCT01459653|O3|Outcome|EP2006, <10% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
128806|NCT01459653|O2|Outcome|EP2006, 10-20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).
152250|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
128807|NCT01459653|O1|Outcome|EP2006, >20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)
128808|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
128809|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
128810|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
128811|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128812|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128813|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128814|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128815|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128816|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128817|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128818|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128819|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128820|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
128821|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
128822|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128823|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128824|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128825|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128826|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128827|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128828|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128829|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128830|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128831|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128832|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128833|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128834|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
128835|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
128836|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128837|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128838|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128839|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128840|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128841|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128842|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128843|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128844|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128845|NCT01459653|O3|Outcome|EP2006: Risk >20%|Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128846|NCT01459653|O2|Outcome|EP2006: Risk 10-20%|Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128847|NCT01459653|O1|Outcome|EP2006: Risk <10%|Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128848|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128849|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128850|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128851|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128852|NCT01459653|O2|Outcome|EP2006: >65kg|Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128853|NCT01459653|O1|Outcome|EP2006: <=65kg|Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128854|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128855|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128856|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128857|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128858|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128859|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128860|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128861|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128862|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128863|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128864|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128865|NCT01459653|O2|Outcome|EP2006: >=65 Years|Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128866|NCT01459653|O1|Outcome|EP2006: <65 Years|Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128867|NCT01459653|O2|Outcome|EP2006: Female|Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128868|NCT01459653|O1|Outcome|EP2006: Male|Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128869|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128870|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128871|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128872|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128968|NCT01458951|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128873|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
128874|NCT01459653|E1|Reported Event|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
128875|NCT01459588|B5|Baseline|Total|Total of all reporting groups
128876|NCT01459588|B4|Baseline|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128877|NCT01459588|B3|Baseline|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128878|NCT01459588|B2|Baseline|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128879|NCT01459588|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128880|NCT01459588|P4|Participant Flow|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128881|NCT01459588|P3|Participant Flow|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128882|NCT01459588|P2|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128883|NCT01459588|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128884|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128885|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128886|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128887|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128888|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128889|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128890|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128891|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128892|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128893|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128894|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128895|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128896|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128897|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128898|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128899|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128900|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128901|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128902|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128903|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128904|NCT01459588|E4|Reported Event|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128905|NCT01459588|E3|Reported Event|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128906|NCT01459588|E2|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
128907|NCT01459588|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
128908|NCT01459068|B3|Baseline|Total|Total of all reporting groups
128909|NCT01459068|B2|Baseline|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128910|NCT01459068|B1|Baseline|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128911|NCT01459068|P2|Participant Flow|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128912|NCT01459068|P1|Participant Flow|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128913|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128914|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128915|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128916|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128917|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128918|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128969|NCT01458951|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
130506|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
128919|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128920|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128921|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128922|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128923|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128924|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128925|NCT01459068|E2|Reported Event|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
128926|NCT01459068|E1|Reported Event|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
128927|NCT01459016|B1|Baseline|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128928|NCT01459016|P1|Participant Flow|Standard of Care|Participants with prodromal to mild Alzheimer’s Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
128929|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128930|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128931|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128932|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128933|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128970|NCT01458951|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128934|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128935|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128936|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128937|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128938|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128939|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128940|NCT01459016|E1|Reported Event|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
128941|NCT01458951|B4|Baseline|Total|Total of all reporting groups
128942|NCT01458951|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128943|NCT01458951|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128944|NCT01458951|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128945|NCT01458951|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128946|NCT01458951|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128947|NCT01458951|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128948|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128949|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128950|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128951|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128952|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128953|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128954|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128955|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128956|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128957|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128958|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128959|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128960|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128961|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128962|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128963|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128964|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128965|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
128966|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
128967|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
130507|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
128971|NCT01458639|B1|Baseline|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128972|NCT01458639|P1|Participant Flow|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128973|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128974|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128975|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128976|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128977|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128978|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128979|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128980|NCT01458639|E1|Reported Event|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
128981|NCT01458587|B3|Baseline|Total|Total of all reporting groups
128982|NCT01458587|B2|Baseline|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
128983|NCT01458587|B1|Baseline|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
128984|NCT01458587|P2|Participant Flow|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
128985|NCT01458587|P1|Participant Flow|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
128986|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
128987|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
128988|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
128989|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
128990|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
128991|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
128992|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
128993|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
128994|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
128995|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
128996|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
128997|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
128998|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
128999|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129000|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129001|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129002|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129003|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129004|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129005|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129006|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129013|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129014|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129015|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129016|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129017|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129018|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129019|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129020|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129021|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129022|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129023|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129024|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129025|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129026|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129027|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129028|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129029|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129030|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129031|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129032|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129033|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129034|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129035|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129036|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129037|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129038|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129039|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129040|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129041|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129042|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129043|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129044|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129045|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129046|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129047|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129048|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129049|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129050|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129051|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129052|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129053|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129054|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129055|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129056|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129057|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129058|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129059|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129060|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129061|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129062|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129063|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129064|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129065|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
152251|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
129066|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129067|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129068|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129069|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129070|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129071|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129072|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129073|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129074|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129075|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129076|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129077|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129078|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129079|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129080|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129081|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129082|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129083|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129084|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129085|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129086|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129087|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129088|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129089|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129090|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129091|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129092|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129093|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129094|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129095|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129096|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129097|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129098|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129099|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129100|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129101|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129102|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129103|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129104|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129105|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129106|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129107|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129108|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129109|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129110|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129111|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129112|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129113|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129114|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129115|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129116|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129117|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129118|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
152252|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
129119|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129120|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129121|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129122|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129123|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129124|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129125|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129126|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129127|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129128|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129129|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129130|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129131|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129132|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129133|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129134|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129135|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129136|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129137|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129138|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
129139|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
129140|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
129141|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
129142|NCT01458587|E2|Reported Event|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
129143|NCT01458587|E1|Reported Event|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
129144|NCT01458561|B3|Baseline|Total|Total of all reporting groups
129145|NCT01458561|B2|Baseline|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129146|NCT01458561|B1|Baseline|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129147|NCT01458561|P2|Participant Flow|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129148|NCT01458561|P1|Participant Flow|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129149|NCT01458561|O2|Outcome|Complications/Adverse Events in Subj. Receiving Gelfoam Plus|"Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129150|NCT01458561|O1|Outcome|Complications/Adverse Events in Subjects Receiving BioFoam|"Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129151|NCT01458561|O2|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129152|NCT01458561|O1|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129153|NCT01458561|O2|Outcome|# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention|"Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129154|NCT01458561|O1|Outcome|# of BioFoam Subjects Requiring Hospitalization/Intervention|"Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129155|NCT01458561|O2|Outcome|Length of Hospital Stay for Gelfoam Plus Subjects|"Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129156|NCT01458561|O1|Outcome|Length of Hospital Stay for BioFoam Surgical Matrix Subjects|"Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129157|NCT01458561|O2|Outcome|Core Body Temp of Gelfoam Plus During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129671|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129158|NCT01458561|O1|Outcome|Core Body Temp of BioFoam Subjects During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129159|NCT01458561|O2|Outcome|Total Time of Procedure for Gelfoam Plus Subjects|"Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129160|NCT01458561|O1|Outcome|Total Time of Procedure for BioFoam Surgical Matrix Subjects|"Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129161|NCT01458561|O2|Outcome|Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129162|NCT01458561|O1|Outcome|BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129163|NCT01458561|O2|Outcome|Presence of Device Via MRI in Gelfoam Plus Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129164|NCT01458561|O1|Outcome|Presence of Device Via MRI in BioFoam Surgical Matrix Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129165|NCT01458561|O2|Outcome|Laboratory Evaluations for Gelfoam Plus Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129166|NCT01458561|O1|Outcome|Laboratory Evaluations for BioFoam Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129167|NCT01458561|O2|Outcome|Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects|"Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129168|NCT01458561|O1|Outcome|Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects|"Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129169|NCT01458561|O2|Outcome|Duration of Postoperative Drainage in Gelfoam Plus Subjects|"Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129170|NCT01458561|O1|Outcome|Duration of Postoperative Drainage in BioFoam Subjects|"Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129171|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129172|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129173|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129174|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129175|NCT01458561|O2|Outcome|Intraop. Blood Loss in Gelfoam Plus Subjects|"Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129176|NCT01458561|O1|Outcome|Intraop. Blood Loss in BioFoam Surgical Matrix Subjects|"Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129177|NCT01458561|O2|Outcome|Achievement of Immediate Hemostasis in Gelfoam Plus Subjects|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129178|NCT01458561|O1|Outcome|Achieve Immediate Hemostasis in BioFoam Subjects/Participants|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129179|NCT01458561|O2|Outcome|Subjects/Participants Receiving Gelfoam Plus|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129180|NCT01458561|O1|Outcome|Subjects/Participants Receiving BioFoam|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129181|NCT01458561|O2|Outcome|Control Bleeding in Gelfoam Plus Subjects/Participants|"Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129182|NCT01458561|O1|Outcome|Control Bleeding in BioFoam Subjects/Participants|"Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129183|NCT01458561|E2|Reported Event|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
129218|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129184|NCT01458561|E1|Reported Event|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
129185|NCT01458535|B7|Baseline|Total|Total of all reporting groups
129186|NCT01458535|B6|Baseline|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129187|NCT01458535|B5|Baseline|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129188|NCT01458535|B4|Baseline|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129189|NCT01458535|B3|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129190|NCT01458535|B2|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129191|NCT01458535|B1|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129192|NCT01458535|P6|Participant Flow|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129193|NCT01458535|P5|Participant Flow|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129194|NCT01458535|P4|Participant Flow|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129195|NCT01458535|P3|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129196|NCT01458535|P2|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129197|NCT01458535|P1|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
129198|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129199|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129200|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129201|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129202|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129203|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129204|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129205|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129206|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129207|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129208|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129209|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129210|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129211|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129212|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129213|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129214|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129215|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129216|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129217|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129219|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129220|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129221|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129222|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129223|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129224|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129225|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129226|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129227|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129228|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129229|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129230|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129231|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129232|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129233|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129234|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
129235|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
129236|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
129237|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
129238|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
129239|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
129240|NCT01458535|E6|Reported Event|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
129241|NCT01458535|E5|Reported Event|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
129242|NCT01458535|E4|Reported Event|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
129243|NCT01458535|E3|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
129244|NCT01458535|E2|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
129245|NCT01458535|E1|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
129246|NCT01458288|B1|Baseline|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
129247|NCT01458288|P1|Participant Flow|TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
129248|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
129249|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
129250|NCT01458288|E1|Reported Event|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
129252|NCT01458275|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129253|NCT01458275|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129254|NCT01458275|B1|Baseline|Placebo|Placebo: Placebo - one actuation per nostril
129255|NCT01458275|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129256|NCT01458275|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129257|NCT01458275|P1|Participant Flow|Placebo|Placebo: Placebo - one actuation per nostril
129258|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129259|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129260|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129261|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129262|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129263|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129264|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129265|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129266|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129267|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129268|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129269|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129270|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129271|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129272|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129273|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129274|NCT01458275|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129275|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129276|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129277|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129278|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129279|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129280|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129281|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129282|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129283|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129284|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129285|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129286|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129287|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129288|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129289|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129290|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129291|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129292|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
129293|NCT01458275|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
129294|NCT01458275|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
129295|NCT01458275|E1|Reported Event|Placebo|Placebo: Placebo - one actuation per nostril
129296|NCT01458249|B3|Baseline|Total|Total of all reporting groups
129538|NCT01457521|P2|Participant Flow|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
129297|NCT01458249|B2|Baseline|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129298|NCT01458249|B1|Baseline|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129299|NCT01458249|P1|Participant Flow|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
129300|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129301|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129302|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129303|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129304|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129305|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129306|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129307|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129308|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129309|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129310|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129311|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129312|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129313|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129314|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
129315|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
129316|NCT01458249|E1|Reported Event|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
129317|NCT01458210|B1|Baseline|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129318|NCT01458210|P1|Participant Flow|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129319|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129320|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129321|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129322|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129323|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129324|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129325|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129326|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129327|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129328|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129329|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129653|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129330|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
129331|NCT01458210|E3|Reported Event|Ortho-Cyclen + Dulaglutide|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
129332|NCT01458210|E2|Reported Event|Ortho-Cyclen Alone|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
129333|NCT01458210|E1|Reported Event|Lead-in (1st Course of Ortho-Cyclen)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in).
129334|NCT01458171|B1|Baseline|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129335|NCT01458171|P1|Participant Flow|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129336|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129337|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129338|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129339|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129340|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129341|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129342|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129343|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129344|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129345|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129346|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129347|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129348|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
129349|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
129350|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129351|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129352|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129353|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129354|NCT01458171|E1|Reported Event|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
129356|NCT01458106|B2|Baseline|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129357|NCT01458106|B1|Baseline|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129358|NCT01458106|P2|Participant Flow|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129359|NCT01458106|P1|Participant Flow|Participants < 6 Years Old|"Pharmacokinetic (PK) subgroup: After a Washout Period of ≥72 hrs, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5±2 minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for PK assessment. Following a second Washout Period of ≥72 hrs, participants receive a single IV injection of rFVIIIFc over 5±2 mins at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129360|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129361|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129362|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129363|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129439|NCT01457950|P1|Participant Flow|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129654|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129364|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129365|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129366|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129367|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129368|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129369|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129370|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129371|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129372|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129373|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129374|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129375|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129376|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129377|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129378|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129379|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129380|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129381|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129382|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129383|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129384|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129385|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129386|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129387|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129388|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129389|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129390|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129391|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129392|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129393|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129394|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129395|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129396|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129397|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129398|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129399|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129400|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129401|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129402|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129403|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129404|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129405|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129406|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129407|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129408|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129409|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129410|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129411|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
129412|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129440|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129413|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129414|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129415|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129416|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129417|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129418|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129419|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129483|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129672|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129420|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129421|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129422|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129423|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129424|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129425|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129426|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129484|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129655|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129427|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129428|NCT01458106|O3|Outcome|All Arms: Total|
129429|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129430|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129431|NCT01458106|E2|Reported Event|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129432|NCT01458106|E1|Reported Event|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
129433|NCT01457950|B3|Baseline|Total|Total of all reporting groups
129434|NCT01457950|B2|Baseline|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129435|NCT01457950|B1|Baseline|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129436|NCT01457950|P4|Participant Flow|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129437|NCT01457950|P3|Participant Flow|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129438|NCT01457950|P2|Participant Flow|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129656|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
130508|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
129441|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129442|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129443|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129444|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129445|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129446|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129447|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129448|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129449|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129450|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129451|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129452|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129485|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129657|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
152253|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
129453|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129454|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129455|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129456|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129457|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129458|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129459|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129460|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129461|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129462|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129463|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129464|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129486|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129537|NCT01457521|B1|Baseline|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
129465|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129466|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129467|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129468|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129469|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129470|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129471|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129472|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129473|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129474|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129475|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129476|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129477|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129478|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129479|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129480|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129481|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129482|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129487|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129488|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129489|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129490|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129491|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129492|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129493|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129494|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129495|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129496|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129497|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129498|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129499|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129500|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129501|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129502|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129503|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129504|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129505|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129506|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129507|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129508|NCT01457950|E4|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Placebo)|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129534|NCT01457703|E1|Reported Event|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129535|NCT01457521|B3|Baseline|Total|Total of all reporting groups
129509|NCT01457950|E3|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Denosumab)|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
129510|NCT01457950|E2|Reported Event|Randomized Phase: Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
129511|NCT01457950|E1|Reported Event|Randomized Phase: Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
129512|NCT01457885|B1|Baseline|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129513|NCT01457885|P1|Participant Flow|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129514|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129515|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129516|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129517|NCT01457885|E1|Reported Event|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
129518|NCT01457703|B3|Baseline|Total|Total of all reporting groups
129519|NCT01457703|B2|Baseline|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129520|NCT01457703|B1|Baseline|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129521|NCT01457703|P2|Participant Flow|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129522|NCT01457703|P1|Participant Flow|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129523|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129524|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129525|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129526|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129527|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129528|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129529|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129530|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
129531|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129532|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129533|NCT01457703|E2|Reported Event|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
129536|NCT01457521|B2|Baseline|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
129539|NCT01457521|P1|Participant Flow|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
129540|NCT01457521|O2|Outcome|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
129541|NCT01457521|O1|Outcome|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
129542|NCT01457521|E2|Reported Event|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
129543|NCT01457521|E1|Reported Event|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
129544|NCT01457430|B1|Baseline|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
129545|NCT01457430|P1|Participant Flow|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
129546|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
129547|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
129548|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
129549|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
129550|NCT01457430|E1|Reported Event|Icatibant|"Open-label study~Icatibant: 30 mg subcutaneous dose of Icatibant"
129551|NCT01457417|B6|Baseline|Total|Total of all reporting groups
129552|NCT01457417|B5|Baseline|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129553|NCT01457417|B4|Baseline|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129554|NCT01457417|B3|Baseline|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129555|NCT01457417|B2|Baseline|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129556|NCT01457417|B1|Baseline|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129557|NCT01457417|P5|Participant Flow|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129558|NCT01457417|P4|Participant Flow|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129658|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129659|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129660|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129661|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129559|NCT01457417|P3|Participant Flow|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129560|NCT01457417|P2|Participant Flow|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129561|NCT01457417|P1|Participant Flow|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129562|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129563|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129564|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129565|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129566|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129567|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129568|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129569|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129662|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
152254|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
129570|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129571|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129572|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129573|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129574|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129575|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129576|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129577|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129578|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129579|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129580|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129663|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
152255|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
129581|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129582|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129583|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129584|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129585|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129586|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129587|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129588|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129589|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129590|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129664|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129665|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129666|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
130509|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
129591|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129592|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129593|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129594|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129595|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129596|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129597|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129598|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129599|NCT01457417|O6|Outcome|Total|Total across all treatment groups
129600|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129601|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129667|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129668|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
130510|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
129602|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129603|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129604|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129605|NCT01457417|O6|Outcome|Total|Total across all treatment groups
129606|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129607|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129608|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129609|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129610|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129611|NCT01457417|E5|Reported Event|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
129612|NCT01457417|E4|Reported Event|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129669|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129670|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
130511|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
129613|NCT01457417|E3|Reported Event|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129614|NCT01457417|E2|Reported Event|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
129615|NCT01457417|E1|Reported Event|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
129616|NCT01457339|B3|Baseline|Total|Total of all reporting groups
129617|NCT01457339|B2|Baseline|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129618|NCT01457339|B1|Baseline|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
129619|NCT01457339|P2|Participant Flow|SPD489 (Lisdexamfetamine Dimesylate)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129620|NCT01457339|P1|Participant Flow|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
129621|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129622|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129623|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129624|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129625|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129626|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129627|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129628|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129629|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129630|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129631|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129632|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129633|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129634|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129635|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129636|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129637|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129638|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129639|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129640|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129641|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129642|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129643|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129644|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129645|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129646|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129647|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129648|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129649|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129650|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129651|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129652|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129673|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129674|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129675|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129676|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129677|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129678|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129679|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129680|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129681|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129682|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129683|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129684|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129685|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129686|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129687|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129688|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129689|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129690|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129691|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129692|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129693|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129694|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129695|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129696|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129697|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129698|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129699|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129700|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129701|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129702|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129703|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129704|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129705|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129706|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129707|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129708|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129709|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129710|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129711|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129712|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129713|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129714|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129715|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129716|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129717|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129718|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129719|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129720|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129721|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129722|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129723|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129724|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129725|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129726|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129727|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129728|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
152256|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
129729|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129730|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129731|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129732|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129733|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129734|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129735|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129736|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129737|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129738|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129739|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129740|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129741|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129742|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129743|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129744|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129745|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129746|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129747|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129748|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129749|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129750|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129751|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129752|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129753|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129754|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129755|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129756|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129757|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129758|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129759|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129760|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129761|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129762|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129763|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129764|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129765|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
129766|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
129767|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
129768|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129769|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129770|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129771|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
129772|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129773|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
129774|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129775|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
129776|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
129777|NCT01457339|E8|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129778|NCT01457339|E7|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129779|NCT01457339|E6|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129941|NCT01456299|O1|Outcome|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
129780|NCT01457339|E5|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129781|NCT01457339|E4|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129782|NCT01457339|E3|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129783|NCT01457339|E2|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
129784|NCT01457339|E1|Reported Event|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
129785|NCT01457053|B1|Baseline|All Study Participants|2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
129786|NCT01457053|P2|Participant Flow|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
129787|NCT01457053|P1|Participant Flow|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
129788|NCT01457053|O2|Outcome|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
129789|NCT01457053|O1|Outcome|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
129790|NCT01457053|E2|Reported Event|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
129791|NCT01457053|E1|Reported Event|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
129792|NCT01457014|B1|Baseline|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
129793|NCT01457014|P4|Participant Flow|Servo Ventilation Manual (Manual SV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
129942|NCT01456299|E3|Reported Event|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
129794|NCT01457014|P3|Participant Flow|Servo Ventilation Auto Mode (autoSV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129795|NCT01457014|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129796|NCT01457014|P1|Participant Flow|Diagnostic Polysomnography (PSG)|A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
129797|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
129798|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129799|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129800|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
129801|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
129802|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129803|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129804|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
129805|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
129806|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129807|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
129808|NCT01457014|O1|Outcome|Diagnostic Polysomnography (PSG)|Baseline overnight Polysomnography (PSG)
129809|NCT01457014|E1|Reported Event|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
129810|NCT01456962|B3|Baseline|Total|Total of all reporting groups
129811|NCT01456962|B2|Baseline|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
129812|NCT01456962|B1|Baseline|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
129813|NCT01456962|P2|Participant Flow|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
129814|NCT01456962|P1|Participant Flow|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
129815|NCT01456962|O2|Outcome|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
129816|NCT01456962|O1|Outcome|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
129817|NCT01456962|E2|Reported Event|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
129818|NCT01456962|E1|Reported Event|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
129819|NCT01456936|B5|Baseline|Total|Total of all reporting groups
129820|NCT01456936|B4|Baseline|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129821|NCT01456936|B3|Baseline|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129822|NCT01456936|B2|Baseline|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
152257|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
129823|NCT01456936|B1|Baseline|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129824|NCT01456936|P4|Participant Flow|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129825|NCT01456936|P3|Participant Flow|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129826|NCT01456936|P2|Participant Flow|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129827|NCT01456936|P1|Participant Flow|Varenicline|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129828|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129829|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129830|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129831|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129832|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129833|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129834|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129835|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129836|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129837|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129838|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129943|NCT01456299|E2|Reported Event|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
129944|NCT01456299|E1|Reported Event|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
129839|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129840|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129841|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129842|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129843|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129844|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129845|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129846|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129847|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129848|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129849|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129850|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129851|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129852|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129853|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129854|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129945|NCT01456195|B4|Baseline|Total|Total of all reporting groups
129946|NCT01456195|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129947|NCT01456195|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
152258|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
129855|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129856|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129857|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129858|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129859|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129860|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129861|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129862|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129863|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129864|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129865|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129866|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129867|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129868|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129869|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129870|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129948|NCT01456195|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129949|NCT01456195|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129950|NCT01456195|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129871|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129872|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129873|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129874|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129875|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129876|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129877|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129878|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129879|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129880|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129881|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129882|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129883|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129884|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129885|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129886|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129951|NCT01456195|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129952|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129953|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129887|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129888|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129889|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129890|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129891|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129892|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129893|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129894|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129895|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129896|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129897|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129898|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129899|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129900|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129901|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129902|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129954|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129955|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129956|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129903|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129904|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129905|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129906|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129907|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129908|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129909|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129910|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129911|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129912|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129913|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129914|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129915|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129916|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129917|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129918|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129957|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129958|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129959|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129919|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129920|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129921|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129922|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129923|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129924|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129925|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129926|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129927|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129928|NCT01456936|E4|Reported Event|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
129929|NCT01456936|E3|Reported Event|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
129930|NCT01456936|E2|Reported Event|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
129931|NCT01456936|E1|Reported Event|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
129932|NCT01456299|B4|Baseline|Total|Total of all reporting groups
129933|NCT01456299|B3|Baseline|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
129934|NCT01456299|B2|Baseline|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
129935|NCT01456299|B1|Baseline|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
129936|NCT01456299|P3|Participant Flow|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
129937|NCT01456299|P2|Participant Flow|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
129938|NCT01456299|P1|Participant Flow|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
129939|NCT01456299|O3|Outcome|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
129940|NCT01456299|O2|Outcome|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
129960|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129961|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129962|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129963|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129964|NCT01456195|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
129965|NCT01456195|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
129966|NCT01456195|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
129967|NCT01456169|B4|Baseline|Total|Total of all reporting groups
129968|NCT01456169|B3|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129969|NCT01456169|B2|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129970|NCT01456169|B1|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129971|NCT01456169|P3|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129972|NCT01456169|P2|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129973|NCT01456169|P1|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129974|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129975|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129976|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129977|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129978|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129979|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129980|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129981|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129982|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129983|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129984|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129985|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129986|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129987|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129988|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129989|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129990|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129991|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129992|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129993|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129994|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129995|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129996|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
129997|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
129998|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
129999|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130000|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130512|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130001|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130002|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130003|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130004|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130005|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130006|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130007|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130008|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130009|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130010|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130011|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130012|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130013|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130014|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130015|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130016|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
130017|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
130018|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
130019|NCT01456169|E4|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
130020|NCT01456169|E3|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
130021|NCT01456169|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
130022|NCT01456169|E1|Reported Event|Monotherapy: Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
130023|NCT01456143|B1|Baseline|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
130024|NCT01456143|P1|Participant Flow|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130025|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130026|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130027|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130028|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130029|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
152259|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
130030|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
130031|NCT01456143|E1|Reported Event|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
130032|NCT01456130|B1|Baseline|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130033|NCT01456130|P1|Participant Flow|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130034|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130035|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130036|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130037|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130038|NCT01456130|E1|Reported Event|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
130039|NCT01456052|B4|Baseline|Total|Total of all reporting groups
130040|NCT01456052|B3|Baseline|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130041|NCT01456052|B2|Baseline|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130042|NCT01456052|B1|Baseline|Placebo|Placebo: Matching placebo administered orally
130043|NCT01456052|P3|Participant Flow|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130044|NCT01456052|P2|Participant Flow|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130045|NCT01456052|P1|Participant Flow|Placebo|Placebo: Matching placebo administered orally
130046|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130047|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130048|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
130049|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130050|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130051|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
130052|NCT01456052|O3|Outcome|Placebo|Placebo: Matching placebo administered orally
130053|NCT01456052|O2|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130054|NCT01456052|O1|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130055|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130056|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130057|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
130058|NCT01456052|E3|Reported Event|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
130059|NCT01456052|E2|Reported Event|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
130060|NCT01456052|E1|Reported Event|Placebo|Placebo: Matching placebo administered orally
130061|NCT01456039|B4|Baseline|Total|Total of all reporting groups
130062|NCT01456039|B3|Baseline|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130063|NCT01456039|B2|Baseline|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130064|NCT01456039|B1|Baseline|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130065|NCT01456039|P3|Participant Flow|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130066|NCT01456039|P2|Participant Flow|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130067|NCT01456039|P1|Participant Flow|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130068|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130069|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130070|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130071|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130072|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130073|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130074|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130513|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130075|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130076|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130077|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130078|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130079|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130080|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130081|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130082|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130083|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130084|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130085|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130086|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130087|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130088|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130089|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130090|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130091|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130092|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130093|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130094|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130095|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130096|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130097|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130098|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130099|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130100|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130101|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130102|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130103|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130104|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130105|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130106|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130107|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130108|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130109|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130110|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130111|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130112|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130113|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130114|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130115|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130116|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130117|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130118|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130119|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130120|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130121|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130122|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130123|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130124|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130125|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130126|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130127|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130128|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130129|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130130|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130131|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130132|NCT01456039|E4|Reported Event|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130133|NCT01456039|E3|Reported Event|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130134|NCT01456039|E2|Reported Event|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
130135|NCT01456039|E1|Reported Event|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
130136|NCT01456000|B3|Baseline|Total|Total of all reporting groups
130137|NCT01456000|B2|Baseline|Control Arm Ablation|"Treatment with standard ablation. Randomized and treated cohort.~Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation."
130138|NCT01456000|B1|Baseline|EAS-AC (HeartLight)|"Treatment with the EAS-AC. Randomized and treated cohort.~EAS-AC (HeartLight): Pulmonary vien isolation"
130139|NCT01456000|P2|Participant Flow|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
130140|NCT01456000|P1|Participant Flow|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
130141|NCT01456000|O2|Outcome|Control Arm Ablation|"Treatment with standard ablation and evaluable for efficacy.~Control Arm Ablation: Treatment with standard ablation."
130142|NCT01456000|O1|Outcome|EAS-AC (HeartLight)|"Treatment with the EAS-AC and evaluable for efficacy.~EAS-AC (HeartLight): Pulmonary vien isolation"
130143|NCT01456000|E2|Reported Event|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
130144|NCT01456000|E1|Reported Event|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
130145|NCT01455545|B1|Baseline|Asthmatic Patients|"Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.~In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA)."
130146|NCT01455545|P2|Participant Flow|Good Control|Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
130147|NCT01455545|P1|Participant Flow|Bad Control|Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
130148|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130149|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
130150|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130151|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
130152|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
130153|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
130154|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130155|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
130156|NCT01455545|O2|Outcome|Good Control|Patients with asthma and goog control. Good control if ACT score > 19.
130157|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control. Bad control if ACT score < or = 19.
130158|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130159|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
130160|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130161|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
130162|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
130163|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
130164|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
130165|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
130166|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
130167|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
130168|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
130169|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
130170|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
130171|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
130172|NCT01455545|E2|Reported Event|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
130173|NCT01455545|E1|Reported Event|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score.
130174|NCT01455519|B3|Baseline|Total|Total of all reporting groups
130175|NCT01455519|B2|Baseline|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
130176|NCT01455519|B1|Baseline|Sugar Pill|Subjects may receive a pill with no medicine.
130177|NCT01455519|P2|Participant Flow|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130178|NCT01455519|P1|Participant Flow|Sugar Pill|Subjects may receive a pill with no medicine.
130179|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130180|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130181|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130182|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130183|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130184|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130185|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130186|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130187|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130188|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130328|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130329|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130189|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130190|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130191|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130192|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130193|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130194|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130195|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130196|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130197|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130198|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130199|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130200|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130201|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130202|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130203|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
130204|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
130205|NCT01455519|E2|Reported Event|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
130206|NCT01455519|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
130207|NCT01455428|B3|Baseline|Total|Total of all reporting groups
130208|NCT01455428|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
130330|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130331|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130209|NCT01455428|B1|Baseline|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130210|NCT01455428|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
130211|NCT01455428|P1|Participant Flow|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130212|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130213|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130214|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130215|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130216|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130217|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130218|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130219|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130220|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130221|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130222|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130223|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130224|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130225|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130226|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130227|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130228|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130229|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130230|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130332|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130333|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130231|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130232|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130233|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130234|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130235|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130236|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130237|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130238|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130239|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130240|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130241|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130242|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130243|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130244|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130245|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130246|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130247|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130248|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130249|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130250|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130251|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130252|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130334|NCT01455194|O4|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130335|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130253|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130254|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130255|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130256|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130257|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130258|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130259|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130260|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
130261|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130262|NCT01455428|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
130263|NCT01455428|E1|Reported Event|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
130264|NCT01455415|B3|Baseline|Total|Total of all reporting groups
130265|NCT01455415|B2|Baseline|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130266|NCT01455415|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130267|NCT01455415|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130268|NCT01455415|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130269|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130270|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130271|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130336|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130272|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130273|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130274|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130275|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130276|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130277|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130278|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130279|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130280|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130281|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130282|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130283|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130337|NCT01455194|O1|Outcome|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
130338|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130284|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130285|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130286|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130287|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130288|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130289|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130290|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130291|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130292|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130293|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130294|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130295|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130339|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130340|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130296|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130297|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130298|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130299|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130300|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130301|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130302|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130303|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130304|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130305|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130306|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130307|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130341|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130342|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130308|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130309|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130310|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130311|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130312|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130313|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130314|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130315|NCT01455415|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130316|NCT01455415|E1|Reported Event|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
130317|NCT01455194|B4|Baseline|Total|Total of all reporting groups
130318|NCT01455194|B3|Baseline|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130319|NCT01455194|B2|Baseline|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130320|NCT01455194|B1|Baseline|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130321|NCT01455194|P4|Participant Flow|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130322|NCT01455194|P3|Participant Flow|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130323|NCT01455194|P2|Participant Flow|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130324|NCT01455194|P1|Participant Flow|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.
130325|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130326|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130327|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130343|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130344|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130345|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130346|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130347|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130348|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130349|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130350|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130351|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130352|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130353|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130354|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130355|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130356|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130357|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130358|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130359|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130360|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130361|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130362|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130363|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130364|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130365|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130366|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130367|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130368|NCT01455194|E4|Reported Event|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130369|NCT01455194|E3|Reported Event|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130370|NCT01455194|E2|Reported Event|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
130371|NCT01455194|E1|Reported Event|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
130372|NCT01455181|B1|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130373|NCT01455181|P1|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130374|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130375|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130376|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130377|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130378|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130379|NCT01455181|E1|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
130380|NCT01455064|B1|Baseline|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
130381|NCT01455064|P1|Participant Flow|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
130382|NCT01455064|O1|Outcome|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
130383|NCT01455064|E1|Reported Event|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
130384|NCT01455012|B3|Baseline|Total|Total of all reporting groups
152260|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
130385|NCT01455012|B2|Baseline|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130386|NCT01455012|B1|Baseline|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130387|NCT01455012|P2|Participant Flow|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130388|NCT01455012|P1|Participant Flow|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130389|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130390|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130391|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130392|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130393|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130394|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130395|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130396|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130397|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130398|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130399|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130400|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130497|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130498|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130499|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130401|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130402|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130403|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130404|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130405|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130406|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130407|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130408|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130409|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130410|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130411|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130412|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130413|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130414|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130415|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130416|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130500|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130501|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130502|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130417|NCT01455012|E2|Reported Event|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130418|NCT01455012|E1|Reported Event|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
130419|NCT01454830|B3|Baseline|Total|Total of all reporting groups
130420|NCT01454830|B2|Baseline|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130421|NCT01454830|B1|Baseline|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130422|NCT01454830|P2|Participant Flow|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130423|NCT01454830|P1|Participant Flow|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130424|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130425|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130426|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130427|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130428|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130429|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130430|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130431|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130432|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130503|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130504|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130433|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130434|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130435|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130436|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130437|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130438|NCT01454830|E2|Reported Event|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
130439|NCT01454830|E1|Reported Event|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
130440|NCT01454791|B3|Baseline|Total|Total of all reporting groups
130441|NCT01454791|B2|Baseline|Placebo Followed by Diclofenac Sodium Gel|"placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130442|NCT01454791|B1|Baseline|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130443|NCT01454791|P2|Participant Flow|Placebo Followed by Diclofenac Sodium Topical Gel|"Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130444|NCT01454791|P1|Participant Flow|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130445|NCT01454791|O2|Outcome|Placebo|Placebo for two weeks: a placebo gel is applied 1-4 times per day
130446|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
130447|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
130448|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
130449|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
130450|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
130451|NCT01454791|E2|Reported Event|Placebo|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130452|NCT01454791|E1|Reported Event|Diclofenac Sodium Topical Gel|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
130453|NCT01454778|B1|Baseline|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130454|NCT01454778|P1|Participant Flow|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
152261|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
130455|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130456|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130457|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130458|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130459|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130460|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130461|NCT01454778|E1|Reported Event|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
130462|NCT01454726|B3|Baseline|Total|Total of all reporting groups
130463|NCT01454726|B2|Baseline|Control Group|receiving the Western medical treatment alone.
130464|NCT01454726|B1|Baseline|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
130465|NCT01454726|P2|Participant Flow|Control Group|receiving the Western medical treatment alone.
130466|NCT01454726|P1|Participant Flow|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
130467|NCT01454726|O2|Outcome|Control Group|receiving the Western medical treatment alone.
130468|NCT01454726|O1|Outcome|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
130469|NCT01454726|E2|Reported Event|Control Group|receiving the Western medical treatment alone.
130470|NCT01454726|E1|Reported Event|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
130471|NCT01454583|B4|Baseline|Total|Total of all reporting groups
130472|NCT01454583|B3|Baseline|Group C|Patients without any RAS inhibition (No-RAS-I)
130473|NCT01454583|B2|Baseline|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130474|NCT01454583|B1|Baseline|Group A|Patients treated with Aliskiren (DRI)
130475|NCT01454583|P3|Participant Flow|No RAS-inhibition|Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
130476|NCT01454583|P2|Participant Flow|ACE-I/ARB|Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
130477|NCT01454583|P1|Participant Flow|Aliskiren|Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
130478|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130479|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130480|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130481|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130482|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130483|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130484|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130485|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130486|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130487|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130488|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130489|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130490|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130491|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130492|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130493|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130494|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130495|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130496|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130514|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130515|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130516|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130517|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130518|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130519|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130520|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130521|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130522|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130523|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130524|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130525|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130526|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130527|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130528|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130529|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130530|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130531|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130532|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130533|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130534|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130535|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130536|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130537|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130538|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
130539|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130540|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
130541|NCT01454583|E3|Reported Event|Group C|Patients without any RAS inhibition (No-RAS-I)
130542|NCT01454583|E2|Reported Event|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
130543|NCT01454583|E1|Reported Event|Group A|Patients treated with Aliskiren (DRI)
130544|NCT01454531|B1|Baseline|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130545|NCT01454531|P1|Participant Flow|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130546|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130547|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130548|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130549|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130550|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130551|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130552|NCT01454531|E1|Reported Event|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
130553|NCT01454505|B4|Baseline|Total|Total of all reporting groups
130554|NCT01454505|B3|Baseline|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130555|NCT01454505|B2|Baseline|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130556|NCT01454505|B1|Baseline|Stage A/Healthy Volunteers|AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
130557|NCT01454505|P4|Participant Flow|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130558|NCT01454505|P3|Participant Flow|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130559|NCT01454505|P2|Participant Flow|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
130560|NCT01454505|P1|Participant Flow|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
130561|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
130562|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
130563|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
130564|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
130565|NCT01454505|O2|Outcome|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
130566|NCT01454505|O1|Outcome|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
130567|NCT01454505|E4|Reported Event|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130568|NCT01454505|E3|Reported Event|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
130569|NCT01454505|E2|Reported Event|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
130570|NCT01454505|E1|Reported Event|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
130571|NCT01454414|B3|Baseline|Total|Total of all reporting groups
130572|NCT01454414|B2|Baseline|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
130573|NCT01454414|B1|Baseline|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
130574|NCT01454414|P2|Participant Flow|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
130575|NCT01454414|P1|Participant Flow|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
130576|NCT01454414|O2|Outcome|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
130577|NCT01454414|O1|Outcome|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
130578|NCT01454414|E2|Reported Event|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
130579|NCT01454414|E1|Reported Event|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
130580|NCT01454401|B1|Baseline|LeucoPatch Treatment of Diabetic Foot Ulcers|"Weekly treatment~LeucoPatch device: weekly treatment"
130581|NCT01454401|P1|Participant Flow|LeucoPatch Treatment of Diabetic Foot Ulcers|Weekly LeucoPatch treatment of diabetic foot ulcers
130582|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
130583|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
130584|NCT01454401|E1|Reported Event|All Patients Consenting to be Enrolled in the Study.|"60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed healing and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included"
130585|NCT01454258|B1|Baseline|Cohort|Surgical patients from 10 hospitals over a period of 13 months
130586|NCT01454258|P1|Participant Flow|Cohort|Surgical patients from 10 hospitals over a period of 13 months
130587|NCT01454258|O3|Outcome|Other Colloids|gelatine, albumin,
130588|NCT01454258|O2|Outcome|Hydroxyethyl Starch|
130589|NCT01454258|O1|Outcome|Crystalloids|
130590|NCT01454258|E1|Reported Event|Cohort|Surgical patients
130591|NCT01454063|B3|Baseline|Total|Total of all reporting groups
130592|NCT01454063|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130593|NCT01454063|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130594|NCT01454063|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130595|NCT01454063|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130596|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130597|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130705|NCT01453855|E1|Reported Event|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
130598|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130599|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130600|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130601|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130602|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130603|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130604|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130605|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130606|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130607|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130608|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130623|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130609|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130610|NCT01454063|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130611|NCT01454063|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
130612|NCT01453998|B4|Baseline|Total|Total of all reporting groups
130613|NCT01453998|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130614|NCT01453998|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130615|NCT01453998|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130616|NCT01453998|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130617|NCT01453998|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130618|NCT01453998|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130619|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130620|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130621|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130622|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130624|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130625|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130626|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130627|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130628|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130629|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130630|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130631|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130632|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130633|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130634|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130635|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130636|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130706|NCT01453725|B3|Baseline|Total|Total of all reporting groups
130771|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
130772|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130637|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130638|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130639|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130640|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130641|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130642|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130643|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130644|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130645|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130646|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130647|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130648|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130649|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130676|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130650|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130651|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130652|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130653|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130654|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130655|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130656|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130657|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130658|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130659|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130660|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130661|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130662|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130701|NCT01453855|P1|Participant Flow|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
130702|NCT01453855|O2|Outcome|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
130663|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130664|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130665|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130666|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130667|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130668|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130669|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130670|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130671|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130672|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130673|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130674|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130675|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130703|NCT01453855|O1|Outcome|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
130704|NCT01453855|E2|Reported Event|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
130677|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130678|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130679|NCT01453998|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130680|NCT01453998|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130681|NCT01453998|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
130682|NCT01453946|B1|Baseline|Entocort|Entocort 6 mg/day
130683|NCT01453946|P1|Participant Flow|Entocort|Entocort 6 mg/day
130684|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
130685|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
130686|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
130687|NCT01453946|E1|Reported Event|Entocort|Entocort 6 mg/day
130688|NCT01453894|B3|Baseline|Total|Total of all reporting groups
130689|NCT01453894|B2|Baseline|Usual Care Control Group|Patients assigned to this arm will receive usual care.
130690|NCT01453894|B1|Baseline|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
130691|NCT01453894|P2|Participant Flow|Usual Care Control Group|Patients assigned to this arm will receive usual care.
130692|NCT01453894|P1|Participant Flow|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
130693|NCT01453894|O2|Outcome|Usual Care Control Group|Patients assigned to this arm will receive usual care.
130694|NCT01453894|O1|Outcome|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
130695|NCT01453894|E2|Reported Event|Usual Care Control Group|Patients assigned to this arm will receive usual care.
130696|NCT01453894|E1|Reported Event|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
130697|NCT01453855|B3|Baseline|Total|Total of all reporting groups
130698|NCT01453855|B2|Baseline|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
130699|NCT01453855|B1|Baseline|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
130700|NCT01453855|P2|Participant Flow|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
152262|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
130707|NCT01453725|B2|Baseline|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130708|NCT01453725|B1|Baseline|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130709|NCT01453725|P2|Participant Flow|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130710|NCT01453725|P1|Participant Flow|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130711|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130712|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130713|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130714|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130715|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130716|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130717|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130718|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130719|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130720|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130721|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130722|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130723|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130724|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130725|NCT01453725|E4|Reported Event|Part 2: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130726|NCT01453725|E3|Reported Event|Part 2: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130769|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130770|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
130727|NCT01453725|E2|Reported Event|Part 1: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
130728|NCT01453725|E1|Reported Event|Part 1: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
130729|NCT01453595|B4|Baseline|Total|Total of all reporting groups
130730|NCT01453595|B3|Baseline|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
130731|NCT01453595|B2|Baseline|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
130732|NCT01453595|B1|Baseline|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
130733|NCT01453595|P3|Participant Flow|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
130734|NCT01453595|P2|Participant Flow|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
130735|NCT01453595|P1|Participant Flow|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
130736|NCT01453595|O1|Outcome|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
130737|NCT01453595|E3|Reported Event|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
130738|NCT01453595|E2|Reported Event|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
130739|NCT01453595|E1|Reported Event|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
130740|NCT01453569|B4|Baseline|Total|Total of all reporting groups
130741|NCT01453569|B3|Baseline|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130742|NCT01453569|B2|Baseline|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130743|NCT01453569|B1|Baseline|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130744|NCT01453569|P3|Participant Flow|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130745|NCT01453569|P2|Participant Flow|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130746|NCT01453569|P1|Participant Flow|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130747|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130748|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130749|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130750|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130751|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130752|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130753|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130754|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130755|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130756|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130757|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130758|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130759|NCT01453569|E3|Reported Event|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
130760|NCT01453569|E2|Reported Event|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
130761|NCT01453569|E1|Reported Event|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
130762|NCT01453413|B1|Baseline|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
130763|NCT01453413|P1|Participant Flow|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
130764|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
130765|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
130766|NCT01453413|E1|Reported Event|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
130767|NCT01453374|B1|Baseline|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130768|NCT01453374|P1|Participant Flow|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130773|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130774|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130775|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130776|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
130777|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
130778|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
130779|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
130780|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
130781|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
130782|NCT01453374|E1|Reported Event|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
130783|NCT01453348|B4|Baseline|Total|Total of all reporting groups
130784|NCT01453348|B3|Baseline|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130785|NCT01453348|B2|Baseline|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130786|NCT01453348|B1|Baseline|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130787|NCT01453348|P3|Participant Flow|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130788|NCT01453348|P2|Participant Flow|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130789|NCT01453348|P1|Participant Flow|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130790|NCT01453348|O3|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130791|NCT01453348|O2|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130792|NCT01453348|O1|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130793|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130826|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131132|NCT01451983|B4|Baseline|Siblings|Siblings of individuals with autism spectrum disorders.
130794|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130795|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130796|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130797|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130798|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130799|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130800|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130801|NCT01453348|E3|Reported Event|ACWY|Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
130802|NCT01453348|E2|Reported Event|HepA/B+ACWY|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
130803|NCT01453348|E1|Reported Event|HepA/B|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
130901|NCT01453075|E2|Reported Event|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
132226|NCT01447706|B2|Baseline|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
130804|NCT01453296|B1|Baseline|VI 25 µg/Placebo or Placebo/VI 25 µg|Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130805|NCT01453296|P2|Participant Flow|Sequence 2: Placebo Followed by VI 25 µg|Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
130806|NCT01453296|P1|Participant Flow|Sequence 1: VI 25 µg Followed by Placebo|Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
130807|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130808|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130809|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130810|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130811|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130812|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130813|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130814|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130815|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130816|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130817|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130818|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130819|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130820|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130821|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130822|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130823|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130824|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130825|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130902|NCT01453075|E1|Reported Event|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
130827|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130828|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130829|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130830|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130831|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130832|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130833|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130834|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130835|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130836|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130837|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130838|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130839|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130840|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130841|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130842|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130843|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130844|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130845|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130846|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130847|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130848|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130849|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130903|NCT01453049|B3|Baseline|Total|Total of all reporting groups
132452|NCT01446289|B2|Baseline|Mothers Placebo|Pregnant women who received one injection of saline solution.
130850|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130851|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130852|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130853|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130854|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130855|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130856|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130857|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130858|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130859|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130860|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130861|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130862|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130863|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130864|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130865|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130866|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130867|NCT01453296|E2|Reported Event|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130868|NCT01453296|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130869|NCT01453166|B4|Baseline|Total|Total of all reporting groups
130870|NCT01453166|B3|Baseline|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130871|NCT01453166|B2|Baseline|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130904|NCT01453049|B2|Baseline|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130872|NCT01453166|B1|Baseline|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130873|NCT01453166|P3|Participant Flow|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130874|NCT01453166|P2|Participant Flow|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130875|NCT01453166|P1|Participant Flow|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130876|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130877|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130878|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130879|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130880|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130881|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130882|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130883|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
131068|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
130884|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130885|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130886|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130887|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130888|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130889|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130890|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130891|NCT01453166|E3|Reported Event|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
130892|NCT01453166|E2|Reported Event|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
130893|NCT01453166|E1|Reported Event|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
130894|NCT01453075|B3|Baseline|Total|Total of all reporting groups
130895|NCT01453075|B2|Baseline|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
130896|NCT01453075|B1|Baseline|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
130897|NCT01453075|P2|Participant Flow|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
130898|NCT01453075|P1|Participant Flow|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
130899|NCT01453075|O2|Outcome|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
130900|NCT01453075|O1|Outcome|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
132453|NCT01446289|B1|Baseline|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
130905|NCT01453049|B1|Baseline|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130906|NCT01453049|P2|Participant Flow|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130907|NCT01453049|P1|Participant Flow|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130908|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130909|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130910|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130911|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130912|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130913|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130914|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130915|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130916|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130917|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
131069|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
130918|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130919|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130920|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130921|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130922|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130923|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130924|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130925|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130926|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130927|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130928|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130929|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130930|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130944|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130931|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130932|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130933|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130934|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130935|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130936|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130937|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130938|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130939|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130940|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130941|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130942|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130943|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
131070|NCT01452529|E3|Reported Event|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
130945|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130946|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130947|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130948|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130949|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130950|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130951|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130952|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130953|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130954|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130955|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130956|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130957|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
131071|NCT01452529|E2|Reported Event|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
130958|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130959|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130960|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130961|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130962|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130963|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130964|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130965|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130966|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130967|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130968|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130969|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130970|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130993|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131129|NCT01452126|O1|Outcome|Femoral Nerve Block|Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.
130971|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130972|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130973|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130974|NCT01453049|E2|Reported Event|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130975|NCT01453049|E1|Reported Event|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
130976|NCT01453036|B4|Baseline|Total|Total of all reporting groups
130977|NCT01453036|B3|Baseline|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
130978|NCT01453036|B2|Baseline|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
130979|NCT01453036|B1|Baseline|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
130980|NCT01453036|P3|Participant Flow|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
130981|NCT01453036|P2|Participant Flow|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
130982|NCT01453036|P1|Participant Flow|Conventional AOC Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
130983|NCT01453036|O3|Outcome|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
130984|NCT01453036|O2|Outcome|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
130985|NCT01453036|O1|Outcome|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
130986|NCT01453036|E3|Reported Event|Mutation Test Group|
130987|NCT01453036|E2|Reported Event|Convential AOM Group|
130988|NCT01453036|E1|Reported Event|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
130989|NCT01453023|B1|Baseline|FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2|All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
130990|NCT01453023|P2|Participant Flow|FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2|Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
130991|NCT01453023|P1|Participant Flow|FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2|Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
130992|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
152263|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
130994|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130995|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130996|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130997|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130998|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
130999|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131000|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131001|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131002|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131003|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131004|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131005|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131006|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131007|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131008|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131009|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131010|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131011|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131012|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131013|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131014|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131015|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131016|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131017|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
152264|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
131018|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131019|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131020|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131021|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131022|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131023|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131024|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131025|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131026|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131027|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131028|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131029|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131030|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131031|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131032|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131033|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131034|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131035|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131036|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131037|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131038|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131039|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131040|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131041|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
152265|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
131042|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131043|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131044|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131045|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131046|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131047|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131048|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131049|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131050|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131051|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131052|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131053|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131054|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131055|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131056|NCT01453023|E2|Reported Event|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131057|NCT01453023|E1|Reported Event|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
131058|NCT01452854|B1|Baseline|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
131059|NCT01452854|P1|Participant Flow|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
131060|NCT01452854|O1|Outcome|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
131061|NCT01452854|E1|Reported Event|Cancer|"The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).~Low recruitment necessitated the closing of the study. No results available."
131062|NCT01452529|B3|Baseline|Total|Total of all reporting groups
131063|NCT01452529|B2|Baseline|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
131064|NCT01452529|B1|Baseline|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
131065|NCT01452529|P3|Participant Flow|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
131066|NCT01452529|P2|Participant Flow|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
131067|NCT01452529|P1|Participant Flow|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects qualification for randomization
131133|NCT01451983|B3|Baseline|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
131072|NCT01452529|E1|Reported Event|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization
131073|NCT01452425|B1|Baseline|Tourniquet|No adverse event
131074|NCT01452425|P1|Participant Flow|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
131075|NCT01452425|O1|Outcome|Tourniquet|
131076|NCT01452425|O1|Outcome|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
131077|NCT01452425|E1|Reported Event|Tourniquet|No adverse event
131078|NCT01452347|B3|Baseline|Total|Total of all reporting groups
131079|NCT01452347|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
131080|NCT01452347|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
131081|NCT01452347|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
131082|NCT01452347|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
131083|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
131084|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
131085|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
131086|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
131087|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
131088|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
131089|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
131090|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
131091|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
131092|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
131093|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
131094|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
131095|NCT01452347|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
131096|NCT01452347|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
131097|NCT01452269|B3|Baseline|Total|Total of all reporting groups
131098|NCT01452269|B2|Baseline|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131099|NCT01452269|B1|Baseline|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131100|NCT01452269|P2|Participant Flow|Delayed Intervention Group|"This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
134140|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
131101|NCT01452269|P1|Participant Flow|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131102|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131103|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131104|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131105|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131106|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131107|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131130|NCT01452126|E1|Reported Event|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
131131|NCT01451983|B5|Baseline|Total|Total of all reporting groups
131108|NCT01452269|E2|Reported Event|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131109|NCT01452269|E1|Reported Event|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
131110|NCT01452152|B4|Baseline|Total|Total of all reporting groups
131111|NCT01452152|B3|Baseline|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
131112|NCT01452152|B2|Baseline|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
131113|NCT01452152|B1|Baseline|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
131114|NCT01452152|P3|Participant Flow|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
131115|NCT01452152|P2|Participant Flow|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
131116|NCT01452152|P1|Participant Flow|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
131117|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
131118|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
131119|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
131120|NCT01452152|E3|Reported Event|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
131121|NCT01452152|E2|Reported Event|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
131122|NCT01452152|E1|Reported Event|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
131123|NCT01452126|B1|Baseline|Ropivacaine|Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
131124|NCT01452126|P1|Participant Flow|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
131125|NCT01452126|O1|Outcome|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
131126|NCT01452126|O4|Outcome|Popliteal Nerve Block|Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
131127|NCT01452126|O3|Outcome|Infraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.
131128|NCT01452126|O2|Outcome|Supraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.
152266|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
131134|NCT01451983|B2|Baseline|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
131135|NCT01451983|B1|Baseline|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
131136|NCT01451983|P4|Participant Flow|Siblings|Siblings of individuals with autism spectrum disorders.
131137|NCT01451983|P3|Participant Flow|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
131138|NCT01451983|P2|Participant Flow|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
131139|NCT01451983|P1|Participant Flow|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
131140|NCT01451983|O4|Outcome|Siblings|Siblings of individuals with autism spectrum disorders.
131141|NCT01451983|O3|Outcome|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
131142|NCT01451983|O2|Outcome|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
131143|NCT01451983|O1|Outcome|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
131144|NCT01451983|E4|Reported Event|Siblings|Siblings of individuals with autism spectrum disorders.
131145|NCT01451983|E3|Reported Event|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
131146|NCT01451983|E2|Reported Event|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
131147|NCT01451983|E1|Reported Event|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
131148|NCT01451931|B4|Baseline|Total|Total of all reporting groups
131149|NCT01451931|B3|Baseline|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131150|NCT01451931|B2|Baseline|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131151|NCT01451931|B1|Baseline|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131152|NCT01451931|P3|Participant Flow|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131153|NCT01451931|P2|Participant Flow|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131154|NCT01451931|P1|Participant Flow|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131155|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131156|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131157|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131158|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131159|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131160|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131161|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131162|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131163|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131164|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131165|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131166|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131167|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131254|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131168|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131169|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131170|NCT01451931|E3|Reported Event|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
131171|NCT01451931|E2|Reported Event|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
131172|NCT01451931|E1|Reported Event|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
131173|NCT01451814|B3|Baseline|Total|Total of all reporting groups
131174|NCT01451814|B2|Baseline|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131175|NCT01451814|B1|Baseline|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131176|NCT01451814|P2|Participant Flow|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131177|NCT01451814|P1|Participant Flow|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131178|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131179|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131180|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131181|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131182|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131183|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131184|NCT01451814|E2|Reported Event|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131185|NCT01451814|E1|Reported Event|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
131186|NCT01451775|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
131187|NCT01451775|P6|Participant Flow|Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
131188|NCT01451775|P5|Participant Flow|Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
131189|NCT01451775|P4|Participant Flow|Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
131190|NCT01451775|P3|Participant Flow|Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
131191|NCT01451775|P2|Participant Flow|Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
131192|NCT01451775|P1|Participant Flow|Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
131193|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131194|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
131195|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131196|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131197|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
131198|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131199|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131200|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
131201|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131202|NCT01451775|E3|Reported Event|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131203|NCT01451775|E2|Reported Event|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
131204|NCT01451775|E1|Reported Event|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
131205|NCT01451762|B4|Baseline|Total|Total of all reporting groups
131206|NCT01451762|B3|Baseline|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
131207|NCT01451762|B2|Baseline|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
131208|NCT01451762|B1|Baseline|Placebo|.9 normal saline IV
131209|NCT01451762|P3|Participant Flow|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
131210|NCT01451762|P2|Participant Flow|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
131211|NCT01451762|P1|Participant Flow|Placebo|.9 normal saline IV
131212|NCT01451762|O3|Outcome|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
131213|NCT01451762|O2|Outcome|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
131214|NCT01451762|O1|Outcome|Placebo|.9 normal saline IV
131215|NCT01451762|E3|Reported Event|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
131216|NCT01451762|E2|Reported Event|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
131217|NCT01451762|E1|Reported Event|Placebo|.9 normal saline IV
131218|NCT01451749|B3|Baseline|Total|Total of all reporting groups
132454|NCT01446289|P4|Participant Flow|Infants Placebo|Infants born from mothers who received one injection of saline solution.
131219|NCT01451749|B2|Baseline|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131220|NCT01451749|B1|Baseline|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
131221|NCT01451749|P2|Participant Flow|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131222|NCT01451749|P1|Participant Flow|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
131223|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131224|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
131225|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131226|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
131227|NCT01451749|O2|Outcome|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131228|NCT01451749|O1|Outcome|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
131229|NCT01451749|E2|Reported Event|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
131230|NCT01451749|E1|Reported Event|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
131231|NCT01451723|B3|Baseline|Total|Total of all reporting groups
131232|NCT01451723|B2|Baseline|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
131233|NCT01451723|B1|Baseline|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
131234|NCT01451723|P2|Participant Flow|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
131235|NCT01451723|P1|Participant Flow|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
131236|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
131237|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
131238|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
131239|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
131240|NCT01451723|E2|Reported Event|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
131241|NCT01451723|E1|Reported Event|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
131242|NCT01451645|B3|Baseline|Total|Total of all reporting groups
131243|NCT01451645|B2|Baseline|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131244|NCT01451645|B1|Baseline|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131245|NCT01451645|P2|Participant Flow|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131246|NCT01451645|P1|Participant Flow|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131247|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131248|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131249|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131250|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131251|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131252|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131253|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131255|NCT01451645|E2|Reported Event|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
131256|NCT01451645|E1|Reported Event|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
131257|NCT01451632|B3|Baseline|Total|Total of all reporting groups
131258|NCT01451632|B2|Baseline|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131259|NCT01451632|B1|Baseline|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131260|NCT01451632|P10|Participant Flow|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131261|NCT01451632|P9|Participant Flow|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131262|NCT01451632|P8|Participant Flow|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131263|NCT01451632|P7|Participant Flow|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131264|NCT01451632|P6|Participant Flow|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
131265|NCT01451632|P5|Participant Flow|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131266|NCT01451632|P4|Participant Flow|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131267|NCT01451632|P3|Participant Flow|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131268|NCT01451632|P2|Participant Flow|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131269|NCT01451632|P1|Participant Flow|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
131270|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131271|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131272|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131273|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131274|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
131275|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131276|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131277|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131278|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131279|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
131280|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
131281|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
131282|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131283|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131284|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131285|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
131286|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
131287|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131288|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131289|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
131290|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131291|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131292|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
131293|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131294|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
131295|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131296|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131297|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131298|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131299|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
131300|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131301|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131302|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131303|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131304|NCT01451632|O8|Outcome|Part 2: Cohort 2|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
131305|NCT01451632|O7|Outcome|Part 2: Cohort 1|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
131306|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131307|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131308|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131309|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
131310|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131311|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
131312|NCT01451632|E2|Reported Event|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131313|NCT01451632|E1|Reported Event|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
131314|NCT01451554|B3|Baseline|Total|Total of all reporting groups
131315|NCT01451554|B2|Baseline|Usual Care|Provided with self-help booklets on diet and exercise.
131316|NCT01451554|B1|Baseline|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
131317|NCT01451554|P2|Participant Flow|Usual Care|Provided with self-help booklets on diet and exercise.
131318|NCT01451554|P1|Participant Flow|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
131319|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
131320|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
131321|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
131322|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
131323|NCT01451554|E2|Reported Event|Usual Care|Provided with self-help booklets on diet and exercise.
131324|NCT01451554|E1|Reported Event|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
131325|NCT01451541|B4|Baseline|Total|Total of all reporting groups
131326|NCT01451541|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131327|NCT01451541|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131328|NCT01451541|B1|Baseline|Placebo|Placebo: placebo - one dose per nostril
131329|NCT01451541|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131330|NCT01451541|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131331|NCT01451541|P1|Participant Flow|Placebo|Placebo: placebo - one dose per nostril
131332|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131333|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131334|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
135208|NCT01433263|E5|Reported Event|Follow-up - 30mg/kg BYM338 Late|Follow-up - 30mg/kg BYM338 Late
131335|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131336|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131337|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131338|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131339|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131340|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131341|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131342|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131343|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131344|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131345|NCT01451541|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131346|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131347|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131348|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131349|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131350|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131351|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131352|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131353|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131354|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131355|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131356|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131357|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131358|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131359|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131360|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131361|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131362|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131363|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131364|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131365|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131366|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
131367|NCT01451541|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
131368|NCT01451541|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
131369|NCT01451541|E1|Reported Event|Placebo|Placebo: placebo - one dose per nostril
131370|NCT01451437|B10|Baseline|Total|Total of all reporting groups
131371|NCT01451437|B9|Baseline|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131372|NCT01451437|B8|Baseline|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131373|NCT01451437|B7|Baseline|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131374|NCT01451437|B6|Baseline|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131375|NCT01451437|B5|Baseline|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
135209|NCT01433263|E4|Reported Event|Follow-up - Placebo|Follow-up - Placebo
131376|NCT01451437|B4|Baseline|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131377|NCT01451437|B3|Baseline|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131378|NCT01451437|B2|Baseline|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131379|NCT01451437|B1|Baseline|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131380|NCT01451437|P9|Participant Flow|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131381|NCT01451437|P8|Participant Flow|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131382|NCT01451437|P7|Participant Flow|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131383|NCT01451437|P6|Participant Flow|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131384|NCT01451437|P5|Participant Flow|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131385|NCT01451437|P4|Participant Flow|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131386|NCT01451437|P3|Participant Flow|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131387|NCT01451437|P2|Participant Flow|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131388|NCT01451437|P1|Participant Flow|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131389|NCT01451437|O9|Outcome|Pt 2 Arm A: MK-8242 300 mg BID|Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
131390|NCT01451437|O8|Outcome|Pt 2 Arm A: MK-8242 250 mg BID|Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
131391|NCT01451437|O7|Outcome|Pt 2 Arm A: MK-8242 210 mg BID|Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
131392|NCT01451437|O6|Outcome|Pt 2 Arm A: MK-8242 170 mg BID|Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
131393|NCT01451437|O5|Outcome|Pt 2 Arm A: MK-8242 120 mg BID|Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
131394|NCT01451437|O4|Outcome|Pt 2 Arm A: MK-8242 250 mg QD|Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
131395|NCT01451437|O3|Outcome|Pt 2 Arm A: MK-8242 120 mg QD|Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
131396|NCT01451437|O2|Outcome|Pt 2 Arm A: MK-8242 60 mg QD|Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
131397|NCT01451437|O1|Outcome|Pt 2 Arm A: MK-8242 30 mg QD|Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
131398|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131399|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131400|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131401|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131402|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131403|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131404|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131405|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131406|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131407|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131440|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131408|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131409|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131410|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131411|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131412|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131413|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131414|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131415|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131416|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131417|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131418|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131419|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131420|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131421|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131422|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131423|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131424|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131425|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131426|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131427|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131428|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131429|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131430|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131431|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131432|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131433|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131434|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131435|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131436|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131437|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131438|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131439|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131441|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131442|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131443|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131444|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131445|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131446|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131447|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131448|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131449|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131450|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131451|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131452|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131453|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131454|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131455|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131456|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131457|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131458|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131459|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131460|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131461|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131462|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131463|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131464|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131465|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131466|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131467|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131468|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131469|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131470|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131471|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131472|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131540|NCT01451424|O5|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131473|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131474|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131475|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131476|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131477|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131478|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131479|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131480|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131481|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131482|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131483|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131484|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131485|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131486|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131487|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131488|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131489|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131490|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131491|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131492|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131493|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131494|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131495|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131496|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131497|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131498|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131499|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131500|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131501|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131502|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131503|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131504|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131505|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131506|NCT01451437|E9|Reported Event|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
131507|NCT01451437|E8|Reported Event|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
131508|NCT01451437|E7|Reported Event|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
131509|NCT01451437|E6|Reported Event|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
131510|NCT01451437|E5|Reported Event|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
131511|NCT01451437|E4|Reported Event|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131512|NCT01451437|E3|Reported Event|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131513|NCT01451437|E2|Reported Event|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131514|NCT01451437|E1|Reported Event|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
131515|NCT01451424|B5|Baseline|Total|Total of all reporting groups
131516|NCT01451424|B4|Baseline|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131517|NCT01451424|B3|Baseline|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)"
131518|NCT01451424|B2|Baseline|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131519|NCT01451424|B1|Baseline|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131520|NCT01451424|P4|Participant Flow|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks~All subjects completed the placebo run-in period and started active dosing."
131521|NCT01451424|P3|Participant Flow|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks~The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing."
131522|NCT01451424|P2|Participant Flow|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
131523|NCT01451424|P1|Participant Flow|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
131524|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131525|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131526|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131527|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131528|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131529|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131530|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131531|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131532|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131533|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131534|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131535|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131536|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131537|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131538|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131539|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131541|NCT01451424|O4|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131542|NCT01451424|O3|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131543|NCT01451424|O2|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131544|NCT01451424|O1|Outcome|Proellex 12 mg PK Group|"Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period.~Proellex: vaginal suppository, daily, for 12 weeks"
131545|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
131546|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
131547|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131548|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131549|NCT01451424|E4|Reported Event|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 12 weeks"
131550|NCT01451424|E3|Reported Event|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131551|NCT01451424|E2|Reported Event|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
131552|NCT01451424|E1|Reported Event|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
131553|NCT01451411|B3|Baseline|Total|Total of all reporting groups
131554|NCT01451411|B2|Baseline|Placebo|Placebo: Intravenous
131555|NCT01451411|B1|Baseline|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131556|NCT01451411|P2|Participant Flow|Placebo|Placebo: Intravenous
131557|NCT01451411|P1|Participant Flow|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131558|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131559|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131560|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131561|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131562|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131563|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131564|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131565|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131566|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131567|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131568|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131569|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131570|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131571|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131572|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131573|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131574|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
131575|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131576|NCT01451411|E2|Reported Event|Placebo|Placebo: Intravenous
131577|NCT01451411|E1|Reported Event|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
131578|NCT01451398|B3|Baseline|Total|Total of all reporting groups
131579|NCT01451398|B2|Baseline|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131580|NCT01451398|B1|Baseline|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131581|NCT01451398|P2|Participant Flow|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131582|NCT01451398|P1|Participant Flow|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131583|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131584|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131585|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131586|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131587|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131588|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131589|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131590|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131591|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131592|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131593|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131594|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131595|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131596|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131597|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131598|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131599|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131600|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131601|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131602|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131603|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131604|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131605|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131606|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131607|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131608|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131609|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131610|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
131611|NCT01451398|E2|Reported Event|Technosphere Powder|"technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere Powder: Placebo Comparator"
131612|NCT01451398|E1|Reported Event|TI Inhalation Powder|"Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere® Insulin: Technosphere® Insulin Inhalation Powder"
131613|NCT01451203|B3|Baseline|Total|Total of all reporting groups
131614|NCT01451203|B2|Baseline|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131615|NCT01451203|B1|Baseline|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131616|NCT01451203|P2|Participant Flow|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131617|NCT01451203|P1|Participant Flow|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131618|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131619|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
135210|NCT01433263|E3|Reported Event|Follow-up - 30mg/kg BYM338|Follow-up - 30mg/kg BYM338
131620|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131621|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131622|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131623|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131624|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131625|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131626|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131627|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131628|NCT01451203|E2|Reported Event|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131629|NCT01451203|E1|Reported Event|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
131630|NCT01450800|B3|Baseline|Total|Total of all reporting groups
131631|NCT01450800|B2|Baseline|Placebo|Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
131632|NCT01450800|B1|Baseline|Nitrofurantoin|Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
131633|NCT01450800|P2|Participant Flow|Placebo|Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
131634|NCT01450800|P1|Participant Flow|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
131635|NCT01450800|O1|Outcome|Urine Cultures Performed|All participants in the final analysis were examined
131636|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131637|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131638|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131639|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131640|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131641|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131642|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
131643|NCT01450800|O2|Outcome|Placebo|Randomized to placebo 1 tab daily while using a catheter for up to 7 days
131644|NCT01450800|O1|Outcome|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily while using a catheter for up to 7 days
131645|NCT01450800|E2|Reported Event|Placebo|Participants randomized to receive placebo 1 tablet by mouth daily each day of catheterization for up to one week after surgery
131646|NCT01450800|E1|Reported Event|Nitrofurantoin|Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
131647|NCT01450787|B3|Baseline|Total|Total of all reporting groups
131648|NCT01450787|B2|Baseline|Non Diabetics|non diabetics over age 40
131649|NCT01450787|B1|Baseline|Diabetics|diabetics over age 40
131650|NCT01450787|P2|Participant Flow|Non Diabetics|non diabetics over age 40
131651|NCT01450787|P1|Participant Flow|Diabetics|diabetics over age 40
131652|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131653|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131654|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131655|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131656|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131657|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131658|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131659|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131660|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131661|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131662|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
131663|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
131664|NCT01450787|E2|Reported Event|Non Diabetics|non diabetics over age 40
131665|NCT01450787|E1|Reported Event|Diabetics|diabetics over age 40
131666|NCT01450761|B3|Baseline|Total|Total of all reporting groups
131965|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131667|NCT01450761|B2|Baseline|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131668|NCT01450761|B1|Baseline|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131669|NCT01450761|P2|Participant Flow|Placebo and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131670|NCT01450761|P1|Participant Flow|Ipilimumab and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131671|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131672|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131673|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131674|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131675|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131676|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131677|NCT01450761|E2|Reported Event|PLACEBO + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
131678|NCT01450761|E1|Reported Event|10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
131679|NCT01450696|B3|Baseline|Total|Total of all reporting groups
131680|NCT01450696|B2|Baseline|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131681|NCT01450696|B1|Baseline|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131682|NCT01450696|P2|Participant Flow|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131875|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
135211|NCT01433263|E2|Reported Event|Core - Placebo|Core - Placebo
131683|NCT01450696|P1|Participant Flow|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131684|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131685|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131686|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131687|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131688|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131689|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131690|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131691|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131692|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131693|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131694|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131695|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131696|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131876|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131697|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131698|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131699|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131700|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131701|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131702|NCT01450696|E2|Reported Event|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131703|NCT01450696|E1|Reported Event|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
131704|NCT01450683|B1|Baseline|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
131705|NCT01450683|P1|Participant Flow|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
131706|NCT01450683|O1|Outcome|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
131707|NCT01450683|E1|Reported Event|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
131708|NCT01450631|B3|Baseline|Total|Total of all reporting groups
131709|NCT01450631|B2|Baseline|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
131710|NCT01450631|B1|Baseline|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
131750|NCT01450189|B1|Baseline|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
152267|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
131711|NCT01450631|P2|Participant Flow|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
131712|NCT01450631|P1|Participant Flow|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
131713|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
131714|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
131715|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
131716|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
131717|NCT01450631|E2|Reported Event|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
131749|NCT01450189|B2|Baseline|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131718|NCT01450631|E1|Reported Event|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
131719|NCT01450397|B1|Baseline|XIAFLEX|Patient who have received XIAFLEX
131720|NCT01450397|P1|Participant Flow|XIAFLEX|0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
131721|NCT01450397|O1|Outcome|XIAFLEX|Subjects receiving one Xiaflex injection
131722|NCT01450397|E1|Reported Event|XIAFLEX|Patient who received XIAFLEX
131723|NCT01450319|B1|Baseline|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131724|NCT01450319|P1|Participant Flow|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131725|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131726|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131727|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131728|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131729|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131730|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131731|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131732|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131733|NCT01450319|E1|Reported Event|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
131734|NCT01450306|B3|Baseline|Total|Total of all reporting groups
131735|NCT01450306|B2|Baseline|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131736|NCT01450306|B1|Baseline|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131737|NCT01450306|P2|Participant Flow|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131738|NCT01450306|P1|Participant Flow|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131739|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131740|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131741|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131742|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131743|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131744|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131745|NCT01450306|E2|Reported Event|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
131746|NCT01450306|E1|Reported Event|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
131747|NCT01450189|B4|Baseline|Total|Total of all reporting groups
131748|NCT01450189|B3|Baseline|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
131872|NCT01449929|B1|Baseline|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131966|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131751|NCT01450189|P3|Participant Flow|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
131752|NCT01450189|P2|Participant Flow|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131753|NCT01450189|P1|Participant Flow|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
131754|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131755|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131756|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131757|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131758|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131759|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131873|NCT01449929|P2|Participant Flow|DRV 800 mg + RTV 100 mg OD|Participants received darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131877|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132095|NCT01448616|P4|Participant Flow|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
131760|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131761|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131762|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131763|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131764|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131765|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131766|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131767|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131768|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131878|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132455|NCT01446289|P3|Participant Flow|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
131769|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131770|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131771|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131772|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131773|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131774|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131775|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131776|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131777|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131879|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132456|NCT01446289|P2|Participant Flow|Mothers Placebo|Pregnant women who received one injection of saline solution.
131778|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131779|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131780|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131781|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131782|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131783|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131784|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131785|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131786|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131880|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132457|NCT01446289|P1|Participant Flow|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
131787|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131788|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131789|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131790|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131791|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131792|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131793|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131794|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131795|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131881|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132458|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
131796|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131797|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131798|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131799|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131800|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131801|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131802|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131803|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131804|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131882|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132459|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
131805|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131806|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131807|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131808|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131809|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131810|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131811|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131812|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131813|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131883|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132460|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
131814|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131815|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131816|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131817|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131818|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131819|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131820|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131821|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131822|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131884|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
132461|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
131823|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
131824|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131825|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
131826|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
131827|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131828|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
131829|NCT01450189|O1|Outcome|Combined Behavioral Intervention Arms|Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
131830|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
131831|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131832|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
131833|NCT01450189|O1|Outcome|Overall|
131834|NCT01450189|O1|Outcome|Overall|
131835|NCT01450189|O1|Outcome|Overall|All arms combined
131874|NCT01449929|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) administered in combination with fixed-dose combination (FDC) dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC]) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
131836|NCT01450189|E3|Reported Event|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
131837|NCT01450189|E2|Reported Event|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
131838|NCT01450189|E1|Reported Event|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
131839|NCT01450007|B4|Baseline|Total|Total of all reporting groups
131840|NCT01450007|B3|Baseline|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131841|NCT01450007|B2|Baseline|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131842|NCT01450007|B1|Baseline|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131843|NCT01450007|P3|Participant Flow|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131844|NCT01450007|P2|Participant Flow|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131845|NCT01450007|P1|Participant Flow|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131846|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131847|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131848|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131849|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131850|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131851|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131852|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131853|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131854|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131855|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131856|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131857|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131858|NCT01450007|E3|Reported Event|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
131859|NCT01450007|E2|Reported Event|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
131860|NCT01450007|E1|Reported Event|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
131861|NCT01449955|B3|Baseline|Total|Total of all reporting groups
131862|NCT01449955|B2|Baseline|Placebo|15mg Placebo administered once in pill form
131863|NCT01449955|B1|Baseline|Rapamycin|15mg Rapamycin administered once in pill form
131864|NCT01449955|P2|Participant Flow|Placebo|15mg Placebo administered once in pill form
131865|NCT01449955|P1|Participant Flow|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
131866|NCT01449955|O2|Outcome|Placebo|15 mg Placebo administered once in pill form
131867|NCT01449955|O1|Outcome|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
131868|NCT01449955|E2|Reported Event|Placebo|Placebo arm
131869|NCT01449955|E1|Reported Event|Rapamycin|15mg Rapamycin
131870|NCT01449929|B3|Baseline|Total|Total of all reporting groups
131871|NCT01449929|B2|Baseline|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
135212|NCT01433263|E1|Reported Event|Core - 30mg/kg BYM338|Core - 30mg/kg BYM338
131885|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131886|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131887|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131888|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131889|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131890|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131891|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131892|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131893|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131894|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131895|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131896|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131897|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131898|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131899|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131900|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131901|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131902|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131903|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131904|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131905|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131906|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131907|NCT01449929|E2|Reported Event|Darunavir 800 mg + Ritonavir 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131908|NCT01449929|E1|Reported Event|Dolutegravir 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
131909|NCT01449747|B3|Baseline|Total|Total of all reporting groups
131910|NCT01449747|B2|Baseline|Responder|Sitagliptin response patients
131911|NCT01449747|B1|Baseline|Non-responder|Sitagliptin non-response patients
131912|NCT01449747|P2|Participant Flow|Responder|Sitagliptin response patients
131913|NCT01449747|P1|Participant Flow|Non-responder|Sitagliptin non-response patients
131914|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
131915|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
131916|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
131917|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
131918|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
131919|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
131920|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
131921|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
131922|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
131923|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
131924|NCT01449747|E2|Reported Event|Responder|Sitagliptin response patients
131925|NCT01449747|E1|Reported Event|Non-responder|Sitagliptin non-response patients
131926|NCT01449734|B1|Baseline|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
131927|NCT01449734|P1|Participant Flow|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
131928|NCT01449734|O1|Outcome|Family Satisfaction|All 215 surveyed relatives are contained in this group, since the study was observational without intervention.
131929|NCT01449734|E1|Reported Event|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
131930|NCT01449708|B3|Baseline|Total|Total of all reporting groups
131963|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131931|NCT01449708|B2|Baseline|TIVA|"patients in both groups receive antiemetic prophylaxis~patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively~postop management in both groups is similar in both groups"
131932|NCT01449708|B1|Baseline|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.~patients in both groups receive antiemetic prophylaxis~postop management in both groups is similar in both groups"
131933|NCT01449708|P2|Participant Flow|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
131934|NCT01449708|P1|Participant Flow|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
131935|NCT01449708|O1|Outcome|All Study Participants|measure included all119 patients depending on surgical procedure
131936|NCT01449708|O2|Outcome|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
131937|NCT01449708|O1|Outcome|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
131938|NCT01449708|O2|Outcome|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
131939|NCT01449708|O1|Outcome|Classic / Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
131940|NCT01449708|E2|Reported Event|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
131941|NCT01449708|E1|Reported Event|Classic/Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
131942|NCT01449539|B1|Baseline|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.
131943|NCT01449539|P1|Participant Flow|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
131944|NCT01449539|O1|Outcome|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
131945|NCT01449539|E1|Reported Event|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
131946|NCT01449526|B3|Baseline|Total|Total of all reporting groups
131947|NCT01449526|B2|Baseline|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131948|NCT01449526|B1|Baseline|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131949|NCT01449526|P2|Participant Flow|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131950|NCT01449526|P1|Participant Flow|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131951|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131952|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131953|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131954|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131955|NCT01449526|E2|Reported Event|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131956|NCT01449526|E1|Reported Event|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
131957|NCT01449513|B3|Baseline|Total|Total of all reporting groups
131958|NCT01449513|B2|Baseline|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131959|NCT01449513|B1|Baseline|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131960|NCT01449513|P2|Participant Flow|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131961|NCT01449513|P1|Participant Flow|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131962|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131964|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131967|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131968|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131969|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131970|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131971|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131972|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131973|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131974|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131975|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131976|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131977|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131978|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131979|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131980|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131981|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131982|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131983|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131984|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131985|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131986|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131987|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131988|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131989|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131990|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131991|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131992|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131993|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131994|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131995|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131996|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131997|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
131998|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
131999|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132000|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132001|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132002|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132003|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132004|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132005|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132006|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132007|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132008|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132009|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132010|NCT01449513|E2|Reported Event|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
132011|NCT01449513|E1|Reported Event|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
132012|NCT01449305|B1|Baseline|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
132013|NCT01449305|P1|Participant Flow|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
132014|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
132015|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
132016|NCT01449305|E1|Reported Event|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
132017|NCT01449266|B1|Baseline|Dotarem®-Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
132018|NCT01449266|P1|Participant Flow|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
132019|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
132020|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
132021|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
132022|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
132023|NCT01449266|E1|Reported Event|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg)."
132024|NCT01449240|B1|Baseline|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
132025|NCT01449240|P1|Participant Flow|No Investigational Treatment or Control Group|This was an observational study for the collection and study of cerebrospinal fluid (CSF) in patients with Hunter syndrome. No investigational treatment was given.
132026|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
132027|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
132028|NCT01449240|E1|Reported Event|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given. Safety analyses were performed in the Safety Population, which was defined as all patients who had undergone a procedure for CSF sample collection. This included a patient who underwent unsuccessful CSF sample collection; no CSF or urine GAG data were available for this adult patient.
132029|NCT01449006|B3|Baseline|Total|Total of all reporting groups
132030|NCT01449006|B2|Baseline|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132031|NCT01449006|B1|Baseline|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132032|NCT01449006|P2|Participant Flow|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132033|NCT01449006|P1|Participant Flow|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
135213|NCT01433250|B3|Baseline|Total|Total of all reporting groups
132034|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132035|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132036|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132037|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132038|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132039|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132040|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132041|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132042|NCT01449006|E2|Reported Event|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
132043|NCT01449006|E1|Reported Event|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
132044|NCT01448850|B3|Baseline|Total|Total of all reporting groups
132045|NCT01448850|B2|Baseline|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132046|NCT01448850|B1|Baseline|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132047|NCT01448850|P2|Participant Flow|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132048|NCT01448850|P1|Participant Flow|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132049|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132050|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132051|NCT01448850|O1|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132052|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132053|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132054|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132055|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132056|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132057|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132058|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132059|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132060|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132061|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132062|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132063|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132064|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132065|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132066|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
132067|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132068|NCT01448850|E2|Reported Event|MEDI8968 300 mg|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
132069|NCT01448850|E1|Reported Event|PLACEBO|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
132070|NCT01448707|B3|Baseline|Total|Total of all reporting groups
132071|NCT01448707|B2|Baseline|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
132072|NCT01448707|B1|Baseline|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132073|NCT01448707|P2|Participant Flow|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
132074|NCT01448707|P1|Participant Flow|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132075|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132076|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132077|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132078|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132079|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132080|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132081|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132082|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132083|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132084|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132085|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132086|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132087|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
132088|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132089|NCT01448707|E2|Reported Event|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
132090|NCT01448707|E1|Reported Event|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
132091|NCT01448616|B4|Baseline|Total|Total of all reporting groups
132092|NCT01448616|B3|Baseline|Oral Placebo + Vaginal Placebo Gel|Participants received matching oral tab and placebo gel both to be used daily
132093|NCT01448616|B2|Baseline|Oral Placebo + Vaginal TFV Gel|Participants randomized to receive matching oral placebo tab once daily + tenofovir (TFV) 1% vaginal gel (40mg in 4ml) to be used daily
132094|NCT01448616|B1|Baseline|Oral TDF + Vaginal Placebo Gel|Participants randomized to receive 300mg Tenofovir Disaproxil Fumarate (TDF) 1 tab daily + the universal placebo vaginal gel (4ml) to be used daily.
135214|NCT01433250|B2|Baseline|Placebo/AIN457|Placebo for core study and AIN in extension study
132096|NCT01448616|P3|Participant Flow|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
132097|NCT01448616|P2|Participant Flow|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
132098|NCT01448616|P1|Participant Flow|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
132099|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
132100|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
132101|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
132102|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
132103|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg/4ml of TFV gel both to be used daily
132104|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
132105|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
132106|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
132107|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
132108|NCT01448616|O3|Outcome|Oral Placebo + Vaginal Placebo|"placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
132109|NCT01448616|O2|Outcome|Oral Placebo + Vaginal TFV Gel|"Tenofovir: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator 40mg/4ml) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals."
132110|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"tenofovir disoproxil fumarate (TDF): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
132111|NCT01448616|E4|Reported Event|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
132112|NCT01448616|E3|Reported Event|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
132113|NCT01448616|E2|Reported Event|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
132114|NCT01448616|E1|Reported Event|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
132115|NCT01448525|B3|Baseline|Total|Total of all reporting groups
132116|NCT01448525|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132117|NCT01448525|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132118|NCT01448525|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132119|NCT01448525|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132120|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132121|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132122|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132123|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132124|NCT01448525|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132125|NCT01448525|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
132126|NCT01448486|B3|Baseline|Total|Total of all reporting groups
132127|NCT01448486|B2|Baseline|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
135215|NCT01433250|B1|Baseline|AIN457/ AIN457|AIN in core study , continued AIN in extension study
132128|NCT01448486|B1|Baseline|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
132129|NCT01448486|P2|Participant Flow|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
132130|NCT01448486|P1|Participant Flow|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
132131|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
132132|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
132133|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
132134|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
132135|NCT01448486|E2|Reported Event|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
132136|NCT01448486|E1|Reported Event|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
132137|NCT01448356|B1|Baseline|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
132138|NCT01448356|P1|Participant Flow|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
132139|NCT01448356|O1|Outcome|Temperature and Humidity|average of three measurements
132140|NCT01448356|O1|Outcome|Temperature and Humidity|Tear evaporation of overall surface
132141|NCT01448356|E1|Reported Event|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
132142|NCT01448213|B3|Baseline|Total|Total of all reporting groups
132143|NCT01448213|B2|Baseline|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
132144|NCT01448213|B1|Baseline|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
132145|NCT01448213|P2|Participant Flow|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
132146|NCT01448213|P1|Participant Flow|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
132147|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
132148|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
132191|NCT01447927|E1|Reported Event|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132192|NCT01447914|B1|Baseline|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
132149|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
132150|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
132151|NCT01448213|E2|Reported Event|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
132152|NCT01448213|E1|Reported Event|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
132153|NCT01448057|B3|Baseline|Total|Total of all reporting groups
132154|NCT01448057|B2|Baseline|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
132155|NCT01448057|B1|Baseline|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
132156|NCT01448057|P2|Participant Flow|Paracetamol Tablets|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
132157|NCT01448057|P1|Participant Flow|Combination Product|"Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
132158|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
132159|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
132160|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
132161|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
132162|NCT01448057|E2|Reported Event|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
132163|NCT01448057|E1|Reported Event|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
132164|NCT01448044|B3|Baseline|Total|Total of all reporting groups
132165|NCT01448044|B2|Baseline|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132166|NCT01448044|B1|Baseline|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132167|NCT01448044|P2|Participant Flow|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132168|NCT01448044|P1|Participant Flow|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132169|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132193|NCT01447914|P1|Participant Flow|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
132462|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
132170|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132171|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132172|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132173|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132174|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132175|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132176|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132177|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132178|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132179|NCT01448044|E2|Reported Event|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
132180|NCT01448044|E1|Reported Event|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
132181|NCT01447927|B3|Baseline|Total|Total of all reporting groups
132182|NCT01447927|B2|Baseline|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132183|NCT01447927|B1|Baseline|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132184|NCT01447927|P2|Participant Flow|Placebo|Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
132185|NCT01447927|P1|Participant Flow|Metformin|Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
132186|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132187|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132188|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132189|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132190|NCT01447927|E2|Reported Event|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
132225|NCT01447706|B3|Baseline|Total|Total of all reporting groups
132194|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
132195|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
132196|NCT01447914|E1|Reported Event|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
132197|NCT01447849|B5|Baseline|Total|Total of all reporting groups
132198|NCT01447849|B4|Baseline|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
132199|NCT01447849|B3|Baseline|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
132200|NCT01447849|B2|Baseline|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
132201|NCT01447849|B1|Baseline|Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
132202|NCT01447849|P4|Participant Flow|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
132203|NCT01447849|P3|Participant Flow|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
132204|NCT01447849|P2|Participant Flow|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
132205|NCT01447849|P1|Participant Flow|Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
132206|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received lubiprostone 24mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
132207|NCT01447849|O1|Outcome|Lubiprostone 24 mcg Bid|Both controls and patients with chronic constipation received lubiprostone 24 mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
132208|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
132209|NCT01447849|O1|Outcome|Lubiprostone 24 mcg BID|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
132210|NCT01447849|E4|Reported Event|Controls on Placebo Then Lubiprostone|Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
132211|NCT01447849|E3|Reported Event|Controls on Lubiprostone Then Placebo|Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
132212|NCT01447849|E2|Reported Event|Chronic Constipation Subjects on Placebo Then Lubiprostone|Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
132213|NCT01447849|E1|Reported Event|Chronic Constipation Subjects on Lubiprostone Then Placebo|Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
132214|NCT01447719|B1|Baseline|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
132215|NCT01447719|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
132216|NCT01447719|O1|Outcome|Autopsy Within 1 Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
132217|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
132218|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
132219|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 year of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
132220|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
132221|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
132222|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
132223|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
132224|NCT01447719|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
132227|NCT01447706|B1|Baseline|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132228|NCT01447706|P2|Participant Flow|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132229|NCT01447706|P1|Participant Flow|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132230|NCT01447706|O4|Outcome|HRG Low: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132231|NCT01447706|O3|Outcome|HRG Low: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132232|NCT01447706|O2|Outcome|HRG High: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132233|NCT01447706|O1|Outcome|HRG High: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132234|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132235|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132236|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132237|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132238|NCT01447706|E2|Reported Event|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
132239|NCT01447706|E1|Reported Event|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
132240|NCT01447576|B1|Baseline|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
132241|NCT01447576|P1|Participant Flow|Brexpiprazole +ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
132242|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
132243|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
132244|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
132245|NCT01447576|E1|Reported Event|Brexpiprazole+ADT|Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
132246|NCT01447511|B6|Baseline|Total|Total of all reporting groups
132247|NCT01447511|B5|Baseline|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132248|NCT01447511|B4|Baseline|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132249|NCT01447511|B3|Baseline|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132250|NCT01447511|B2|Baseline|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
132251|NCT01447511|B1|Baseline|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132252|NCT01447511|P5|Participant Flow|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132253|NCT01447511|P4|Participant Flow|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132254|NCT01447511|P3|Participant Flow|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132255|NCT01447511|P2|Participant Flow|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
132256|NCT01447511|P1|Participant Flow|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132257|NCT01447511|O5|Outcome|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132258|NCT01447511|O4|Outcome|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132259|NCT01447511|O3|Outcome|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132260|NCT01447511|O2|Outcome|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
132261|NCT01447511|O1|Outcome|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132262|NCT01447511|E5|Reported Event|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132263|NCT01447511|E4|Reported Event|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132264|NCT01447511|E3|Reported Event|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132265|NCT01447511|E2|Reported Event|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
132266|NCT01447511|E1|Reported Event|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
132267|NCT01447433|B3|Baseline|Total|Total of all reporting groups
132268|NCT01447433|B2|Baseline|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132269|NCT01447433|B1|Baseline|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132270|NCT01447433|P2|Participant Flow|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132271|NCT01447433|P1|Participant Flow|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132272|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132273|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132274|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132275|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132276|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132277|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132278|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132279|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132280|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132281|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132282|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132283|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132284|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132285|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132286|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132287|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132288|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132289|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132290|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132291|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132292|NCT01447433|E2|Reported Event|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132293|NCT01447433|E1|Reported Event|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
132294|NCT01447420|B4|Baseline|Total|Total of all reporting groups
132295|NCT01447420|B3|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132296|NCT01447420|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132297|NCT01447420|B1|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132298|NCT01447420|P3|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132299|NCT01447420|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132322|NCT01447225|P8|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132300|NCT01447420|P1|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132301|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132302|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132303|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132304|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132305|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132306|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132307|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132308|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132309|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132310|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg, orally daily, 48 weeks
132311|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132312|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
132313|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
132314|NCT01447420|E1|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for < 75 kg and 1200 mg per day for >= 75 kg, orally daily, 48 weeks.
132315|NCT01447225|B5|Baseline|Total|Total of all reporting groups
132316|NCT01447225|B4|Baseline|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
132317|NCT01447225|B3|Baseline|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
132318|NCT01447225|B2|Baseline|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
132319|NCT01447225|B1|Baseline|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
132320|NCT01447225|P10|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
132321|NCT01447225|P9|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132463|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
132323|NCT01447225|P7|Participant Flow|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132324|NCT01447225|P6|Participant Flow|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132325|NCT01447225|P5|Participant Flow|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132326|NCT01447225|P4|Participant Flow|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132327|NCT01447225|P3|Participant Flow|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
132328|NCT01447225|P2|Participant Flow|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
132329|NCT01447225|P1|Participant Flow|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
132330|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
132331|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132332|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132333|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132334|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132335|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132336|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132337|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
132338|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
132339|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
132340|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
132341|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
132342|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
132343|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
132344|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
132345|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
132346|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
132347|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
132348|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
132349|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
132350|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
132351|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
132352|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
132353|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
132354|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
132355|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
152268|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
132356|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
132357|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132358|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132359|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132360|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132361|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132362|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132363|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
132364|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
132365|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
132366|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
132367|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132368|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132369|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132370|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132371|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132372|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132373|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
132374|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
132375|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
132376|NCT01447225|O1|Outcome|MM-121 + Cabazitaxel|MTD of MM-121 + Cabazitaxel combination - NOTE: MTD of MM-121 for this combination provided in separate endpoint
132377|NCT01447225|O1|Outcome|MM-121 + Pemetrexed|MTD of combination of MM-121 + Pemetrexed - NOTE: MTD of MM-121 for this combination provided in separate endpoint
132378|NCT01447225|O1|Outcome|MM-121 + Carboplatin|MTD of the MM-121 + Carboplatin combination NOTE: MTD of MM-121 for this combination provided in separate endpoint
132379|NCT01447225|O1|Outcome|MM-121 + Gemcitabine|
132380|NCT01447225|O4|Outcome|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
132381|NCT01447225|O3|Outcome|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
132382|NCT01447225|O2|Outcome|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
132383|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Gemcitabine: administered IV at 1000 mg/m2 or 1250 mg/m2"
132384|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
152269|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
132385|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132386|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
132387|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132388|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
132389|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132390|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
132391|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
132392|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
132393|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
132394|NCT01447225|E4|Reported Event|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
132395|NCT01447225|E3|Reported Event|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
132396|NCT01447225|E2|Reported Event|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
132397|NCT01447225|E1|Reported Event|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
132398|NCT01447121|B1|Baseline|Intended Users of the System|Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
132399|NCT01447121|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
132400|NCT01447121|O1|Outcome|Study Staff|Study staff also used the investigational Blood Glucose Monitoring System (BGMS) (Tatus/Tradewind Investigational Blood Glucose Meter)
132401|NCT01447121|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
132402|NCT01447121|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
132403|NCT01447017|B3|Baseline|Total|Total of all reporting groups
132404|NCT01447017|B2|Baseline|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132405|NCT01447017|B1|Baseline|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132406|NCT01447017|P2|Participant Flow|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132407|NCT01447017|P1|Participant Flow|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132408|NCT01447017|O2|Outcome|Placebo for DPK-060 Ear Drops|Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
132409|NCT01447017|O1|Outcome|DPK-060 2% Ear Drops|Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
132410|NCT01447017|E2|Reported Event|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132411|NCT01447017|E1|Reported Event|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
132412|NCT01446796|B1|Baseline|Continuous RV Pacing|Study terminated early due to recruitment
132413|NCT01446796|P2|Participant Flow|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132414|NCT01446796|P1|Participant Flow|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
152270|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
132415|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
132416|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132417|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
132418|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132419|NCT01446796|O2|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132420|NCT01446796|O1|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
132421|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
132422|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132423|NCT01446796|E2|Reported Event|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
132424|NCT01446796|E1|Reported Event|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
132425|NCT01446705|B3|Baseline|Total|Total of all reporting groups
132426|NCT01446705|B2|Baseline|Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
132427|NCT01446705|B1|Baseline|Control (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
132428|NCT01446705|P2|Participant Flow|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
132429|NCT01446705|P1|Participant Flow|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
132430|NCT01446705|O2|Outcome|Enrolled in HIE|Patients in this arm represent Veterans seen at the Indianapolis VAMC enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
132431|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this arm represent Veterans seen at the Indianapolis VAMC NOT enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
132432|NCT01446705|O2|Outcome|Enrolled in HIE|This group represents veterans were enrolled in Health Information Exchange via VLER
132433|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this group were not enrolled in Health Information Exchange.
132434|NCT01446705|E2|Reported Event|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
132435|NCT01446705|E1|Reported Event|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
132436|NCT01446419|B3|Baseline|Total|Total of all reporting groups
132437|NCT01446419|B2|Baseline|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132438|NCT01446419|B1|Baseline|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132439|NCT01446419|P2|Participant Flow|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132440|NCT01446419|P1|Participant Flow|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132441|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132442|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132443|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132444|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132445|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132446|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132447|NCT01446419|E2|Reported Event|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
132448|NCT01446419|E1|Reported Event|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
132449|NCT01446289|B5|Baseline|Total|Total of all reporting groups
132450|NCT01446289|B4|Baseline|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132451|NCT01446289|B3|Baseline|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
152271|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
132464|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132465|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
132466|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132467|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
132468|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132469|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
132470|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
132471|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
132472|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
132473|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
132474|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
132475|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
132476|NCT01446289|O4|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132477|NCT01446289|O3|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
132478|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
132479|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
132480|NCT01446289|E4|Reported Event|Infants Placebo|Infants born from mothers who received one injection of saline solution.
132481|NCT01446289|E3|Reported Event|Infants GBS|Infants born from mothers who received one dose of GBS vaccine.
132482|NCT01446289|E2|Reported Event|Mothers Placebo|Pregnant women who received one injection of saline solution.
132483|NCT01446289|E1|Reported Event|Mothers GBS|Pregnant women who received one dose of GBS vaccine.
132484|NCT01446250|B1|Baseline|All Enrolled Participants|Analysis was performed on all enrolled participants.
132485|NCT01446250|P4|Participant Flow|No Intervention|Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
132486|NCT01446250|P3|Participant Flow|PEGinf + RBV|Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
132487|NCT01446250|P2|Participant Flow|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
132488|NCT01446250|P1|Participant Flow|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
132489|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
132490|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
132491|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
132492|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
132493|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
132494|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
132495|NCT01446250|E4|Reported Event|No Intervention|AE was discovered while taking no intervention.
132496|NCT01446250|E3|Reported Event|PEGinf + RBV|AE occurred while taking only PEGinf + RBV.
132497|NCT01446250|E2|Reported Event|Boceprevir|AE occurred while taking Boceprevir + PEGinf + RBV.
132498|NCT01446250|E1|Reported Event|Alisporivir|Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
132499|NCT01445951|B4|Baseline|Total|Total of all reporting groups
132500|NCT01445951|B3|Baseline|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132501|NCT01445951|B2|Baseline|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132502|NCT01445951|B1|Baseline|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132503|NCT01445951|P3|Participant Flow|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132504|NCT01445951|P2|Participant Flow|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132505|NCT01445951|P1|Participant Flow|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132506|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132507|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132508|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132509|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132510|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132511|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132512|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132513|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132514|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132515|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132516|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132517|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132518|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132519|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132520|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132521|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132522|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132523|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132524|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132525|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132526|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132527|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132528|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132529|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132530|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132531|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132532|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132533|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132534|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132535|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132536|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
132537|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132538|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
132539|NCT01445951|E3|Reported Event|Aspart Group|"Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry~Insulin Aspart in combination with a basal insulin: Injectable insulin"
132540|NCT01445951|E2|Reported Event|Technosphere® Insulin With MedTone C Inhaler|"Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin"
132541|NCT01445951|E1|Reported Event|Technosphere ® Insulin-Gen2 Group|"Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin"
132542|NCT01445873|B1|Baseline|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132543|NCT01445873|P1|Participant Flow|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132544|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132545|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132546|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132547|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132548|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132549|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132550|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132551|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132552|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132553|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132554|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132555|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132556|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132557|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132558|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132559|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132560|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132561|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132562|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132563|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132564|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132565|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132566|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132567|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132568|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132569|NCT01445873|E1|Reported Event|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
132570|NCT01445847|B3|Baseline|Total|Total of all reporting groups
132571|NCT01445847|B2|Baseline|Placebo|Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
132572|NCT01445847|B1|Baseline|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
132573|NCT01445847|P2|Participant Flow|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
132574|NCT01445847|P1|Participant Flow|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
132575|NCT01445847|O2|Outcome|Placebo|Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
132576|NCT01445847|O1|Outcome|Lidocaine|Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued
132577|NCT01445847|E2|Reported Event|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
132578|NCT01445847|E1|Reported Event|Lidocaine|Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
132579|NCT01445769|B1|Baseline|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132580|NCT01445769|P1|Participant Flow|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported Patients' Global Impression of Change (PGIC) score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132581|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132582|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
152272|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
132583|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132584|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132585|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132586|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132587|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132588|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132589|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132590|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132591|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132592|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132593|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
152273|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
132594|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
132595|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
132596|NCT01445769|E1|Reported Event|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
132597|NCT01445678|B3|Baseline|Total|Total of all reporting groups
132598|NCT01445678|B2|Baseline|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132599|NCT01445678|B1|Baseline|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132600|NCT01445678|P2|Participant Flow|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
132601|NCT01445678|P1|Participant Flow|CXA-201 and Metronidazole as Treatment for cIAI|"CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.~Of the 979 treated subjects in the integrated analysis set, 482 received CXA."
132602|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132603|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132604|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132605|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132606|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132607|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132608|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132609|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132610|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132611|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132612|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132613|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132614|NCT01445678|E2|Reported Event|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
132615|NCT01445678|E1|Reported Event|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
132616|NCT01445652|B3|Baseline|Total|Total of all reporting groups
132617|NCT01445652|B2|Baseline|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
132618|NCT01445652|B1|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
132619|NCT01445652|P2|Participant Flow|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
132620|NCT01445652|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
132621|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
132622|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
132623|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
132624|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
132625|NCT01445652|E2|Reported Event|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
132626|NCT01445652|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
132627|NCT01445626|B1|Baseline|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132628|NCT01445626|P1|Participant Flow|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132629|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132630|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132631|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132632|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132633|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132634|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132635|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132636|NCT01445626|E1|Reported Event|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
132637|NCT01445613|B1|Baseline|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132638|NCT01445613|P1|Participant Flow|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132639|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132640|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132641|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132642|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132643|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
132644|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
132645|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
132646|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
132647|NCT01445613|O2|Outcome|In Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
132648|NCT01445613|O1|Outcome|In Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
132649|NCT01445613|O2|Outcome|Composite of Peri-procedural DS in the Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
132650|NCT01445613|O1|Outcome|Composite of Peri-procedural DS in the Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
132651|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132652|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132653|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132654|NCT01445613|E1|Reported Event|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
132655|NCT01445548|B1|Baseline|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
152274|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
132656|NCT01445548|P1|Participant Flow|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132657|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132658|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132659|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132660|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132661|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132662|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132663|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132664|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132665|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132666|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132667|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132668|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132669|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132670|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132671|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132672|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132673|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132674|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132675|NCT01445548|E1|Reported Event|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
132676|NCT01444924|B3|Baseline|Total|Total of all reporting groups
132677|NCT01444924|B2|Baseline|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
132678|NCT01444924|B1|Baseline|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
132679|NCT01444924|P2|Participant Flow|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
132680|NCT01444924|P1|Participant Flow|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
132681|NCT01444924|O2|Outcome|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
132682|NCT01444924|O1|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
132683|NCT01444924|E2|Reported Event|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
132684|NCT01444924|E1|Reported Event|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
132685|NCT01444898|B1|Baseline|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132686|NCT01444898|P1|Participant Flow|Exenatide|All subjects enrolled in this study will be given Exenatide for 6 months. The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
132687|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132688|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132689|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132690|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132691|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132692|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132693|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132694|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132695|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132696|NCT01444898|E1|Reported Event|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
132697|NCT01444781|B4|Baseline|Total|Total of all reporting groups
132698|NCT01444781|B3|Baseline|Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
135219|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
132699|NCT01444781|B2|Baseline|DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132700|NCT01444781|B1|Baseline|DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
132701|NCT01444781|P3|Participant Flow|Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132702|NCT01444781|P2|Participant Flow|Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132703|NCT01444781|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132704|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132705|NCT01444781|O2|Outcome|Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132706|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132707|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132708|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132709|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132710|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132711|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132712|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132713|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132714|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132715|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132716|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132717|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132718|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132719|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132720|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132721|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132722|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
132723|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132724|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
132725|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132726|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132727|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132728|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
132823|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for for 12 weeks
132729|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132730|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
132731|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132732|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132733|NCT01444781|O1|Outcome|Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132734|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
132735|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132736|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
132737|NCT01444781|E3|Reported Event|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
132738|NCT01444781|E2|Reported Event|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
132739|NCT01444781|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
132740|NCT01444651|B3|Baseline|Total|Total of all reporting groups
132741|NCT01444651|B2|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132742|NCT01444651|B1|Baseline|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132743|NCT01444651|P2|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132744|NCT01444651|P1|Participant Flow|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132745|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132746|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132747|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132748|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132749|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132750|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132751|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132752|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132753|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132754|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132755|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132756|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132757|NCT01444651|E2|Reported Event|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
132758|NCT01444651|E1|Reported Event|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
132759|NCT01444456|B1|Baseline|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
132760|NCT01444456|P1|Participant Flow|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
132761|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132762|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132763|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132764|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132765|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132766|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
132767|NCT01444456|E1|Reported Event|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
132768|NCT01444430|B3|Baseline|Total|Total of all reporting groups
132769|NCT01444430|B2|Baseline|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132770|NCT01444430|B1|Baseline|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132771|NCT01444430|P2|Participant Flow|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132772|NCT01444430|P1|Participant Flow|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132773|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132774|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132775|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132776|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132777|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132778|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132779|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132780|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132781|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132782|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132783|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132784|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132785|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132786|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132787|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132788|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132824|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
132789|NCT01444430|E2|Reported Event|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
132790|NCT01444430|E1|Reported Event|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
132791|NCT01444417|B3|Baseline|Total|Total of all reporting groups
132792|NCT01444417|B2|Baseline|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132793|NCT01444417|B1|Baseline|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132794|NCT01444417|P2|Participant Flow|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132795|NCT01444417|P1|Participant Flow|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132796|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132797|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132798|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132799|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132800|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132801|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132802|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132803|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132804|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132805|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132806|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132807|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132808|NCT01444417|E2|Reported Event|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
132809|NCT01444417|E1|Reported Event|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
132810|NCT01444391|B1|Baseline|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132811|NCT01444391|P1|Participant Flow|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132812|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132813|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132814|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132815|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132816|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132817|NCT01444391|E1|Reported Event|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
132818|NCT01444300|B3|Baseline|Total|Total of all reporting groups
132819|NCT01444300|B2|Baseline|Placebo|Placebo: placebo pill, twice daily (bid), for 12 weeks
132820|NCT01444300|B1|Baseline|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
132821|NCT01444300|P2|Participant Flow|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
132822|NCT01444300|P1|Participant Flow|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
132825|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
132826|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
132827|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
132828|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
132829|NCT01444300|E2|Reported Event|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
132830|NCT01444300|E1|Reported Event|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
132831|NCT01444287|B1|Baseline|All Subjects|Subjects who were enrolled and randomized to a trial arm.
132832|NCT01444287|P1|Participant Flow|All Study Participants|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
132833|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132834|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132835|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132836|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132837|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132838|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132839|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132840|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132841|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132842|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132843|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132844|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132845|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132846|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132847|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132848|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132849|NCT01444287|E4|Reported Event|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132850|NCT01444287|E3|Reported Event|Polymacon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132851|NCT01444287|E2|Reported Event|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132852|NCT01444287|E1|Reported Event|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
132853|NCT01444092|B1|Baseline|Entocort|Entocort™ EC 9/6/3 mg
132854|NCT01444092|P1|Participant Flow|Entocort|Entocort™ EC 9/6/3 mg
132855|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
132856|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
132857|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
132858|NCT01444092|E1|Reported Event|Entocort|Entocort™ EC 9/6/3 mg
132859|NCT01443923|B3|Baseline|Total|Total of all reporting groups
132860|NCT01443923|B2|Baseline|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132861|NCT01443923|B1|Baseline|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132862|NCT01443923|P2|Participant Flow|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132863|NCT01443923|P1|Participant Flow|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132864|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132865|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132866|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132867|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132868|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132869|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132870|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132871|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132872|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132873|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
135220|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
132874|NCT01443923|E2|Reported Event|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132875|NCT01443923|E1|Reported Event|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
132876|NCT01443858|B4|Baseline|Total|Total of all reporting groups
132877|NCT01443858|B3|Baseline|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132878|NCT01443858|B2|Baseline|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132879|NCT01443858|B1|Baseline|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132880|NCT01443858|P3|Participant Flow|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132881|NCT01443858|P2|Participant Flow|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132882|NCT01443858|P1|Participant Flow|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132883|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132884|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132885|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132920|NCT01443494|E1|Reported Event|Septic Shock Patients Despite EGDT|Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
132886|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132887|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132888|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132889|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132890|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132891|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132892|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132893|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132894|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132921|NCT01443364|B1|Baseline|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133078|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
132895|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132896|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132897|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132898|NCT01443858|E3|Reported Event|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132899|NCT01443858|E2|Reported Event|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132900|NCT01443858|E1|Reported Event|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
132901|NCT01443845|B3|Baseline|Total|Total of all reporting groups
132902|NCT01443845|B2|Baseline|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132903|NCT01443845|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
132904|NCT01443845|P2|Participant Flow|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132905|NCT01443845|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
132906|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132907|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
132908|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132909|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
132910|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132911|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
132912|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132913|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
132914|NCT01443845|E2|Reported Event|Roflumilast|Roflumilast 500 µg, oral administration, once per day
132915|NCT01443845|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
132916|NCT01443494|B1|Baseline|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
132917|NCT01443494|P1|Participant Flow|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
132918|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
132919|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
132922|NCT01443364|P1|Participant Flow|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132923|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132924|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132925|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132926|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132927|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132928|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132929|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132930|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132931|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132932|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132933|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132934|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132935|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132936|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132937|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132938|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132939|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132940|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132941|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133076|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
132942|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132943|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132944|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132945|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132946|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132947|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132948|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132949|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132950|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132951|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132952|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132953|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132954|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132955|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132956|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132957|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132958|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132959|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132960|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132961|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133077|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
132962|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132963|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132964|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132965|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132966|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132967|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132968|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132969|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132970|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132971|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132972|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132973|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132974|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132975|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132976|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132977|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132978|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132979|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132980|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132981|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133111|NCT01443026|B1|Baseline|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
132982|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132983|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132984|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132985|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132986|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132987|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132988|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132989|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132990|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132991|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132992|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132993|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132994|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132995|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132996|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132997|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132998|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
132999|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133000|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133001|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133139|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
133002|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133003|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133004|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133005|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133006|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133007|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133008|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133009|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133010|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133011|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133012|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133013|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133014|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133015|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133016|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133017|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133018|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133019|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133020|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133021|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133174|NCT01442181|P1|Participant Flow|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133022|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133023|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133024|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133025|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133026|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133027|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133028|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133029|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133030|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133031|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133032|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133033|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133034|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133035|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133036|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133037|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133038|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133039|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133040|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133041|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133175|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
152275|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
133042|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133043|NCT01443364|E1|Reported Event|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
133044|NCT01443130|B7|Baseline|Total|Total of all reporting groups
133045|NCT01443130|B6|Baseline|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133046|NCT01443130|B5|Baseline|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
133047|NCT01443130|B4|Baseline|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
133048|NCT01443130|B3|Baseline|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133049|NCT01443130|B2|Baseline|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133050|NCT01443130|B1|Baseline|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133051|NCT01443130|P6|Participant Flow|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133052|NCT01443130|P5|Participant Flow|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
133053|NCT01443130|P4|Participant Flow|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
133054|NCT01443130|P3|Participant Flow|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133055|NCT01443130|P2|Participant Flow|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133056|NCT01443130|P1|Participant Flow|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133057|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133058|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133059|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133060|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133061|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133062|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133063|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133064|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133065|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133066|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133067|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133068|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133069|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133070|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
133071|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
133072|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133073|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
133074|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
133075|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133079|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133080|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133081|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133082|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133083|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133084|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133085|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133086|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133087|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133088|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133089|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133090|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133091|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133092|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133093|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133094|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133095|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133096|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133097|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133098|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133099|NCT01443130|E6|Reported Event|Infant SP IPT|Infants born to maternal participants who received SP IPT.
133100|NCT01443130|E5|Reported Event|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
133101|NCT01443130|E4|Reported Event|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
133102|NCT01443130|E3|Reported Event|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133103|NCT01443130|E2|Reported Event|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
133104|NCT01443130|E1|Reported Event|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
133105|NCT01443078|B1|Baseline|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
133106|NCT01443078|P1|Participant Flow|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
133107|NCT01443078|O1|Outcome|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
133108|NCT01443078|E1|Reported Event|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
133109|NCT01443026|B3|Baseline|Total|Total of all reporting groups
133110|NCT01443026|B2|Baseline|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
133112|NCT01443026|P2|Participant Flow|Placebo|"Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
133113|NCT01443026|P1|Participant Flow|Lycopene|"Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
133114|NCT01443026|O2|Outcome|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
133115|NCT01443026|O1|Outcome|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
133116|NCT01443026|E2|Reported Event|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
133117|NCT01443026|E1|Reported Event|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
133118|NCT01442844|B3|Baseline|Total|Total of all reporting groups
133119|NCT01442844|B2|Baseline|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
133120|NCT01442844|B1|Baseline|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
133121|NCT01442844|P2|Participant Flow|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
133122|NCT01442844|P1|Participant Flow|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
133123|NCT01442844|O2|Outcome|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
133124|NCT01442844|O1|Outcome|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
133125|NCT01442844|E2|Reported Event|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
133126|NCT01442844|E1|Reported Event|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
133127|NCT01442779|B1|Baseline|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133128|NCT01442779|P1|Participant Flow|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133129|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133130|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133131|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133132|NCT01442779|E1|Reported Event|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
133133|NCT01442688|B3|Baseline|Total|Total of all reporting groups
133134|NCT01442688|B2|Baseline|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
133135|NCT01442688|B1|Baseline|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
133136|NCT01442688|P2|Participant Flow|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
133137|NCT01442688|P1|Participant Flow|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
133138|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
133140|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
133141|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
133142|NCT01442688|E2|Reported Event|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
133143|NCT01442688|E1|Reported Event|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
133144|NCT01442675|B1|Baseline|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
133145|NCT01442675|P1|Participant Flow|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
133146|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133147|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133148|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133149|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133150|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133151|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
133152|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
133153|NCT01442675|E1|Reported Event|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
133154|NCT01442376|B4|Baseline|Total|Total of all reporting groups
133155|NCT01442376|B3|Baseline|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
133156|NCT01442376|B2|Baseline|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
133157|NCT01442376|B1|Baseline|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
133158|NCT01442376|P3|Participant Flow|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
133159|NCT01442376|P2|Participant Flow|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
133160|NCT01442376|P1|Participant Flow|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
133161|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
133162|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
133163|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
133164|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
133165|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
133166|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
133167|NCT01442376|E3|Reported Event|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
133168|NCT01442376|E2|Reported Event|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
133169|NCT01442376|E1|Reported Event|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
133170|NCT01442181|B3|Baseline|Total|Total of all reporting groups
133171|NCT01442181|B2|Baseline|Medical Therapy|Patients are treated with rhythm and rate control medications.
133172|NCT01442181|B1|Baseline|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133173|NCT01442181|P2|Participant Flow|Medical Therapy|Patients are treated with rhythm and rate control medications.
133176|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133177|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
133178|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133179|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
133180|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133181|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
133182|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133183|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133184|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133185|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133186|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133187|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133188|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133189|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133190|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133191|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133192|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133193|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
133194|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133195|NCT01442181|E2|Reported Event|Medical Therapy|Patients are treated with rhythm and rate control medications.
133196|NCT01442181|E1|Reported Event|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
133197|NCT01442155|B1|Baseline|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
133198|NCT01442155|P1|Participant Flow|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
133199|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
133200|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
133201|NCT01442155|E1|Reported Event|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
133202|NCT01442129|B3|Baseline|Total|Total of all reporting groups
133203|NCT01442129|B2|Baseline|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
133204|NCT01442129|B1|Baseline|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
133205|NCT01442129|P2|Participant Flow|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
133206|NCT01442129|P1|Participant Flow|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
133207|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
133208|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
133209|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
135221|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
133210|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
133211|NCT01442129|E2|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
133212|NCT01442129|E1|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
133213|NCT01442103|B1|Baseline|Silver Gel, Chronic Wounds|Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
133214|NCT01442103|P1|Participant Flow|Silver Gel, Chronic Wounds|The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
133215|NCT01442103|O1|Outcome|Device Common Dressing|Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (>80%) water content and water soluble polymer chains.
133216|NCT01442103|E1|Reported Event|Device Common Dressing|Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund
133217|NCT01442064|B7|Baseline|Total|Total of all reporting groups
133218|NCT01442064|B6|Baseline|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133219|NCT01442064|B5|Baseline|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133220|NCT01442064|B4|Baseline|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133221|NCT01442064|B3|Baseline|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133222|NCT01442064|B2|Baseline|Ranibizumab (0.3 mg BRAVO)|In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133223|NCT01442064|B1|Baseline|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133224|NCT01442064|P6|Participant Flow|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133225|NCT01442064|P5|Participant Flow|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133226|NCT01442064|P4|Participant Flow|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133227|NCT01442064|P3|Participant Flow|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133228|NCT01442064|P2|Participant Flow|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133229|NCT01442064|P1|Participant Flow|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133230|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
133438|NCT01441401|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8
152276|NCT01355523|E2|Reported Event|Placebo|6 mg oral placebo daily
133231|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133232|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133233|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133234|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133235|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133236|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
133237|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133238|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133239|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133240|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133241|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133242|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
133243|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133244|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133245|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133246|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133247|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133248|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
133439|NCT01441401|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure 8 or less
133249|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133250|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133251|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133252|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133253|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133254|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
133255|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
133256|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
133257|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133258|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
133259|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
133260|NCT01442064|E3|Reported Event|Ranibizumab (0.5 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
133261|NCT01442064|E2|Reported Event|Ranibizumab (0.3 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
133262|NCT01442064|E1|Reported Event|Ranibizumab (Sham)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.
133263|NCT01442038|B3|Baseline|Total|Total of all reporting groups
133264|NCT01442038|B2|Baseline|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133265|NCT01442038|B1|Baseline|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133266|NCT01442038|P2|Participant Flow|Placebo|Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133267|NCT01442038|P1|Participant Flow|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133440|NCT01441401|O4|Outcome|Unknown|Participants with unknown severity of baseline epileptic seizure
152277|NCT01355523|E1|Reported Event|Melatonin|6 mg oral melatonin daily
133268|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133269|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133270|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133271|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133272|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133273|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133274|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133275|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133276|NCT01442038|E2|Reported Event|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
133277|NCT01442038|E1|Reported Event|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
133278|NCT01441973|B3|Baseline|Total|Total of all reporting groups
133279|NCT01441973|B2|Baseline|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133280|NCT01441973|B1|Baseline|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133281|NCT01441973|P2|Participant Flow|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133282|NCT01441973|P1|Participant Flow|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133283|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133284|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133285|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133286|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133287|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133288|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133289|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133290|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133291|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
133292|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133293|NCT01441973|E2|Reported Event|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
152278|NCT01355484|B3|Baseline|Total|Total of all reporting groups
133294|NCT01441973|E1|Reported Event|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
133295|NCT01441960|B1|Baseline|Succinylcholine and Rocuronium|All study participants
133296|NCT01441960|P2|Participant Flow|Rocuronium First , Then Succinylcholine|"After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.~By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline."
133297|NCT01441960|P1|Participant Flow|Succinylcholine First, Then Rocuronium|"After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.~By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg."
133298|NCT01441960|O2|Outcome|Rocuronium|Duration of induced seizure
133299|NCT01441960|O1|Outcome|Succinylcholine|Duration of induced seizure after standard ECT
133300|NCT01441960|O2|Outcome|Rocuronium|Time to recovery after single bolus administered at the beginning of ECT therapy
133301|NCT01441960|O1|Outcome|Succinylchline|Time to recovery after single bolus administered at the beginning of ECT therapy
133302|NCT01441960|O2|Outcome|NMBA- Rocuronium|Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
133303|NCT01441960|O1|Outcome|NMBA: Sux|"Cross-over randomized controlled, assessor blinded clinical trial.~Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."
133304|NCT01441960|E2|Reported Event|NMBA: Rocuronium|No adverse events occurred during the study
133305|NCT01441960|E1|Reported Event|NMBA: Succinylcholine|No adverse events occurred during the study
133306|NCT01441843|B3|Baseline|Total|Total of all reporting groups
133307|NCT01441843|B2|Baseline|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
133308|NCT01441843|B1|Baseline|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
133309|NCT01441843|P2|Participant Flow|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
133310|NCT01441843|P1|Participant Flow|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
133311|NCT01441843|O2|Outcome|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
133312|NCT01441843|O1|Outcome|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
133313|NCT01441843|E2|Reported Event|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
133314|NCT01441843|E1|Reported Event|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
133315|NCT01441765|B3|Baseline|Total|Total of all reporting groups
133316|NCT01441765|B2|Baseline|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133317|NCT01441765|B1|Baseline|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133318|NCT01441765|P2|Participant Flow|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133319|NCT01441765|P1|Participant Flow|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133320|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133321|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133322|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133323|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133324|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133325|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133326|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133327|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133328|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133329|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133330|NCT01441765|E2|Reported Event|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
133331|NCT01441765|E1|Reported Event|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
133332|NCT01441596|B4|Baseline|Total|Total of all reporting groups
133333|NCT01441596|B3|Baseline|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133334|NCT01441596|B2|Baseline|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133335|NCT01441596|B1|Baseline|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133336|NCT01441596|P3|Participant Flow|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133337|NCT01441596|P2|Participant Flow|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133338|NCT01441596|P1|Participant Flow|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133339|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133340|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133341|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133342|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133343|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133344|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133345|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133346|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133347|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133348|NCT01441596|E3|Reported Event|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
133349|NCT01441596|E2|Reported Event|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
133350|NCT01441596|E1|Reported Event|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
133351|NCT01441466|B3|Baseline|Total|Total of all reporting groups
133352|NCT01441466|B2|Baseline|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133353|NCT01441466|B1|Baseline|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
133441|NCT01441401|O3|Outcome|Severe|Participants with severe epileptic seizure at baseline
133442|NCT01441401|O2|Outcome|Moderate|Participants with moderate epileptic seizure at baseline
133354|NCT01441466|P2|Participant Flow|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133355|NCT01441466|P1|Participant Flow|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
133356|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133357|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
133358|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133359|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
133360|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133361|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
133362|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133363|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
133364|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133365|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
133366|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133367|NCT01441466|O1|Outcome|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
133368|NCT01441466|E2|Reported Event|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
133369|NCT01441466|E1|Reported Event|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
133370|NCT01441440|B4|Baseline|Total|Total of all reporting groups
133371|NCT01441440|B3|Baseline|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133372|NCT01441440|B2|Baseline|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133373|NCT01441440|B1|Baseline|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133374|NCT01441440|P3|Participant Flow|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133375|NCT01441440|P2|Participant Flow|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133376|NCT01441440|P1|Participant Flow|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133377|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133378|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133379|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133443|NCT01441401|O1|Outcome|Mild|Participants with mild epileptic seizure at baseline
133380|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133381|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133382|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133383|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133384|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133385|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133386|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133387|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133388|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133389|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133390|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133391|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133392|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133393|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133394|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133395|NCT01441440|E3|Reported Event|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
133396|NCT01441440|E2|Reported Event|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
133397|NCT01441440|E1|Reported Event|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
133398|NCT01441414|B1|Baseline|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133399|NCT01441414|P1|Participant Flow|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133497|NCT01440972|B1|Baseline|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
135222|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
133400|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133401|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133402|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133403|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133404|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133405|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133406|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133407|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133408|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133409|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
133410|NCT01441414|O4|Outcome|All-causality CTCAE Grade 5|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented
133411|NCT01441414|O3|Outcome|All-causality CTCAE Grade 4|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented
133412|NCT01441414|O2|Outcome|All-causality CTCAE Grade 3|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented
133413|NCT01441414|O1|Outcome|All-causality CTCAE Grade 2|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented
133414|NCT01441414|O8|Outcome|Treatment-related Overall|Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133415|NCT01441414|O7|Outcome|All-causality Overall|Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133416|NCT01441414|O6|Outcome|Treatment-related CTCAE Grade 5|Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133417|NCT01441414|O5|Outcome|Treatment-related CTCAE Grade 4|Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133418|NCT01441414|O4|Outcome|Treatment-related CTCAE Grade 3|Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133419|NCT01441414|O3|Outcome|All-causality CTCAE Grade 5|Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133420|NCT01441414|O2|Outcome|All-causality CTCAE Grade 4|Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133421|NCT01441414|O1|Outcome|All-causality CTCAE Grade 3|Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
133422|NCT01441414|E1|Reported Event|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
134199|NCT01437878|B2|Baseline|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
133423|NCT01441401|B1|Baseline|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133424|NCT01441401|P1|Participant Flow|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133425|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133426|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133427|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133428|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133429|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133430|NCT01441401|O2|Outcome|Long Term|Participants who received gabapentin for 1 year or more
133431|NCT01441401|O1|Outcome|Non-Long Term|Participants who received gabapentin for less than 1 year
133432|NCT01441401|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
133433|NCT01441401|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
133434|NCT01441401|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
133435|NCT01441401|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
133436|NCT01441401|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
133437|NCT01441401|O3|Outcome|Unknown|Participants with unknown frequency of baseline epileptic seizure
133444|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133445|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133446|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133447|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133448|NCT01441401|E1|Reported Event|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
133449|NCT01441245|B3|Baseline|Total|Total of all reporting groups
133450|NCT01441245|B2|Baseline|iIV Group|The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
133451|NCT01441245|B1|Baseline|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
133452|NCT01441245|P2|Participant Flow|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
133453|NCT01441245|P1|Participant Flow|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
133454|NCT01441245|O2|Outcome|Dopamine Infusion in iIV|Prevalence of dopamine infusion in intermittent intravenous furosemide infusion.
133455|NCT01441245|O1|Outcome|Dopamine Infusion in cIV|Prevalence of dopamine infusion in continuous intravenous furosemide infusion.
133456|NCT01441245|O2|Outcome|GFR at Discharge in iIV|Mean GFR at discharge in intermittent intravenous fursoemide infusion.
133457|NCT01441245|O1|Outcome|GFR at Discharge in cIV|Mean GFR at discharge in continuous intravenous fursoemide infusion.
133458|NCT01441245|O2|Outcome|GFR Change in iIV|Mean GFR change in intermittent intravenous fursoemide infusion.
133459|NCT01441245|O1|Outcome|GFR Change in cIV|Mean GFR change in continuous intravenous fursoemide infusion.
133460|NCT01441245|O2|Outcome|BNP Change in iIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
133461|NCT01441245|O1|Outcome|BNP Change in cIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
133462|NCT01441245|O2|Outcome|BNP Levels at Discharge in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
133498|NCT01440972|P2|Participant Flow|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133499|NCT01440972|P1|Participant Flow|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
134281|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
133463|NCT01441245|O1|Outcome|BNP Levels at Discharge in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
133464|NCT01441245|O2|Outcome|Changes in Creatinine in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
133465|NCT01441245|O1|Outcome|Changes in Creatinine in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
133466|NCT01441245|O2|Outcome|Creatinine at Discharge in iIV|Mean creatinine at discharge in intermittent intravenous fursoemide infusion.
133467|NCT01441245|O1|Outcome|Creatinine at Discharge in cIV|Mean creatinine at discharge in continuous intravenous fursoemide infusion.
133468|NCT01441245|O2|Outcome|Lenght of Hospitalization in iIV|Prevalence of hospital stay > 10 days in intermittent intravenous furosemide infusion.
133469|NCT01441245|O1|Outcome|Lenght of Hospitalization in cIV|Prevalence of hospital stay > 10 days in continuous intravenous furosemide infusion.
133470|NCT01441245|O2|Outcome|Urine Output in iIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
133471|NCT01441245|O1|Outcome|Urine Output in cIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
133472|NCT01441245|E2|Reported Event|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
133473|NCT01441245|E1|Reported Event|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
133474|NCT01441180|B4|Baseline|Total|Total of all reporting groups
133475|NCT01441180|B3|Baseline|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
133476|NCT01441180|B2|Baseline|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
133477|NCT01441180|B1|Baseline|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
133478|NCT01441180|P3|Participant Flow|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
133479|NCT01441180|P2|Participant Flow|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
133480|NCT01441180|P1|Participant Flow|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
133481|NCT01441180|O3|Outcome|Phase 2 Arm B|"(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).~GS7977~RBV"
133482|NCT01441180|O2|Outcome|Phase 2 Arm A|"(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)~GS7977~RBV"
133483|NCT01441180|O1|Outcome|Phase 1|"Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.~GS7977~RBV"
133484|NCT01441180|O3|Outcome|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
133485|NCT01441180|O2|Outcome|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
133486|NCT01441180|O1|Outcome|Phase 1|
133487|NCT01441180|E3|Reported Event|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
133488|NCT01441180|E2|Reported Event|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
133489|NCT01441180|E1|Reported Event|Phase 1 (Sofosbuvir + Weight Based RBV)|(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
133490|NCT01441102|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
133491|NCT01441102|P1|Participant Flow|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
133492|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
133493|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
133494|NCT01441102|E1|Reported Event|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
133495|NCT01440972|B3|Baseline|Total|Total of all reporting groups
133496|NCT01440972|B2|Baseline|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133500|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133501|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133502|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133503|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133504|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133505|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133506|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133507|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133508|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133509|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133510|NCT01440972|E2|Reported Event|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
133511|NCT01440972|E1|Reported Event|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
133512|NCT01440959|B1|Baseline|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133513|NCT01440959|P1|Participant Flow|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133514|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133515|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133516|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133517|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133518|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133519|NCT01440959|E1|Reported Event|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
133520|NCT01440946|B3|Baseline|Total|Total of all reporting groups
133521|NCT01440946|B2|Baseline|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133522|NCT01440946|B1|Baseline|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133523|NCT01440946|P2|Participant Flow|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133524|NCT01440946|P1|Participant Flow|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last pharmacokinetic (PK) sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133525|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133526|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133527|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133591|NCT01440634|O2|Outcome|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
153768|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
133528|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133529|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133530|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133531|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133532|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133533|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133534|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133535|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133536|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133537|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133538|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133539|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133540|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133554|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133541|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133542|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133543|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133544|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133545|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133546|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133547|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133548|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133549|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133550|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133551|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133552|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133553|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133555|NCT01440946|O3|Outcome|Total|All Participants
133592|NCT01440634|O1|Outcome|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
133556|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133557|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133558|NCT01440946|E2|Reported Event|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133559|NCT01440946|E1|Reported Event|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
133560|NCT01440881|B3|Baseline|Total|Total of all reporting groups
133561|NCT01440881|B2|Baseline|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
133562|NCT01440881|B1|Baseline|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133563|NCT01440881|P2|Participant Flow|Placebo|"infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
133564|NCT01440881|P1|Participant Flow|Nesiritide|"infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133565|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
133566|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133567|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
133568|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133569|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
133570|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133571|NCT01440881|O2|Outcome|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
133572|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133573|NCT01440881|E2|Reported Event|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
133574|NCT01440881|E1|Reported Event|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
133575|NCT01440647|B3|Baseline|Total|Total of all reporting groups
133576|NCT01440647|B2|Baseline|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
133577|NCT01440647|B1|Baseline|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
133578|NCT01440647|P2|Participant Flow|CPAP|After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
133579|NCT01440647|P1|Participant Flow|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
133580|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
133581|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
133582|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
133583|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
133584|NCT01440647|E2|Reported Event|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
133585|NCT01440647|E1|Reported Event|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
133586|NCT01440634|B3|Baseline|Total|Total of all reporting groups
133587|NCT01440634|B2|Baseline|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
133588|NCT01440634|B1|Baseline|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
133589|NCT01440634|P2|Participant Flow|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
133590|NCT01440634|P1|Participant Flow|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
133593|NCT01440634|E2|Reported Event|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
133594|NCT01440634|E1|Reported Event|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
133595|NCT01440595|B3|Baseline|Total|Total of all reporting groups
133596|NCT01440595|B2|Baseline|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133597|NCT01440595|B1|Baseline|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133598|NCT01440595|P3|Participant Flow|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133599|NCT01440595|P2|Participant Flow|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133600|NCT01440595|P1|Participant Flow|Grazoprevir 200 mg + Peg-IFN + RBV|Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133601|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133602|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133603|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133604|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133605|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133606|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133607|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133608|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133609|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133610|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133611|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133612|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133613|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133614|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133615|NCT01440595|E2|Reported Event|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
133616|NCT01440595|E1|Reported Event|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
133617|NCT01440569|B3|Baseline|Total|Total of all reporting groups
133618|NCT01440569|B2|Baseline|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133619|NCT01440569|B1|Baseline|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133620|NCT01440569|P2|Participant Flow|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133621|NCT01440569|P1|Participant Flow|Treatment-Naive|Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133622|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133623|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133624|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133625|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
135223|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
133626|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133627|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133628|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133629|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133630|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133631|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133632|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133633|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133634|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133635|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133636|NCT01440569|E2|Reported Event|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133637|NCT01440569|E1|Reported Event|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
133638|NCT01440543|B5|Baseline|Total|Total of all reporting groups
133639|NCT01440543|B4|Baseline|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
133640|NCT01440543|B3|Baseline|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
133641|NCT01440543|B2|Baseline|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
133642|NCT01440543|B1|Baseline|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
133643|NCT01440543|P4|Participant Flow|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
133644|NCT01440543|P3|Participant Flow|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
133645|NCT01440543|P2|Participant Flow|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
133646|NCT01440543|P1|Participant Flow|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
133647|NCT01440543|O4|Outcome|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
133648|NCT01440543|O3|Outcome|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
133649|NCT01440543|O2|Outcome|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
133650|NCT01440543|O1|Outcome|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
133651|NCT01440543|E4|Reported Event|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
133652|NCT01440543|E3|Reported Event|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
133653|NCT01440543|E2|Reported Event|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
133654|NCT01440543|E1|Reported Event|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
133655|NCT01440517|B1|Baseline|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
133656|NCT01440517|P1|Participant Flow|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
133657|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
133658|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
133659|NCT01440517|E1|Reported Event|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
133660|NCT01440387|B3|Baseline|Total|Total of all reporting groups
133661|NCT01440387|B2|Baseline|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133662|NCT01440387|B1|Baseline|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133663|NCT01440387|P2|Participant Flow|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133664|NCT01440387|P1|Participant Flow|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133665|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133666|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133667|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133668|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133669|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133670|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133671|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133672|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133673|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133674|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133675|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133676|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133677|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133678|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133679|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133680|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133681|NCT01440387|E2|Reported Event|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133682|NCT01440387|E1|Reported Event|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
133683|NCT01440374|B4|Baseline|Total|Total of all reporting groups
133684|NCT01440374|B3|Baseline|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
133685|NCT01440374|B2|Baseline|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
133686|NCT01440374|B1|Baseline|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
133687|NCT01440374|P3|Participant Flow|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
133717|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133688|NCT01440374|P2|Participant Flow|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
133689|NCT01440374|P1|Participant Flow|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 milligrams (mg) daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
133690|NCT01440374|O2|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
133691|NCT01440374|O1|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
133692|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
133693|NCT01440374|E3|Reported Event|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
133694|NCT01440374|E2|Reported Event|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
133695|NCT01440374|E1|Reported Event|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
133696|NCT01440322|B3|Baseline|Total|Total of all reporting groups
133697|NCT01440322|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133698|NCT01440322|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133699|NCT01440322|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133700|NCT01440322|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133701|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133702|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133703|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133704|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133705|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133706|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133707|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133708|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133709|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133710|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133711|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133712|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133713|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133714|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133715|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133716|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
135224|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
133718|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133719|NCT01440322|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
133720|NCT01440322|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
133721|NCT01440283|B1|Baseline|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133722|NCT01440283|P1|Participant Flow|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133723|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133724|NCT01440283|O6|Outcome|Left Kidney: S-I|Nine participants who underwent all 3 scans.
133725|NCT01440283|O5|Outcome|Left Kidney: A-P|Nine participants who underwent all 3 scans.
133726|NCT01440283|O4|Outcome|Left Kidney: M-L|Nine participants who underwent all 3 scans.
133727|NCT01440283|O3|Outcome|Right Kidney: S-I|Nine participants who underwent all 3 scans.
133728|NCT01440283|O2|Outcome|Right Kidney: A-P|Nine participants who underwent all 3 scans.
133729|NCT01440283|O1|Outcome|Right Kidney: M-L|Nine participants who underwent all 3 scans.
133730|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133731|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133732|NCT01440283|E1|Reported Event|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
133733|NCT01440101|B4|Baseline|Total|Total of all reporting groups
133734|NCT01440101|B3|Baseline|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133735|NCT01440101|B2|Baseline|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133736|NCT01440101|B1|Baseline|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133737|NCT01440101|P3|Participant Flow|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133738|NCT01440101|P2|Participant Flow|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133739|NCT01440101|P1|Participant Flow|Open Label Natalizumab|300 mg intravenous (IV) infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133740|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133741|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133742|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133743|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133744|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133745|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133746|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133747|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133748|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133749|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133750|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133751|NCT01440101|O1|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133752|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133753|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133754|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133755|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133756|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133757|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133758|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133759|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133760|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133761|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133762|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133763|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133764|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133765|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133766|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133767|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133768|NCT01440101|E3|Reported Event|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133769|NCT01440101|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
133770|NCT01440101|E1|Reported Event|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
133771|NCT01440049|B1|Baseline|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133772|NCT01440049|P1|Participant Flow|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133773|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133774|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133775|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133776|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133777|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133778|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133779|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133780|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
135225|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
133781|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133782|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133783|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133784|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133785|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133786|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133787|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133788|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133789|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133790|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133791|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133792|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133793|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133794|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133795|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133796|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133797|NCT01440049|E1|Reported Event|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
133798|NCT01439724|B3|Baseline|Total|Total of all reporting groups
133799|NCT01439724|B2|Baseline|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
133800|NCT01439724|B1|Baseline|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
133824|NCT01439204|B1|Baseline|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133918|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133801|NCT01439724|P2|Participant Flow|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
133802|NCT01439724|P1|Participant Flow|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
133803|NCT01439724|O2|Outcome|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
133804|NCT01439724|O1|Outcome|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
133805|NCT01439724|E2|Reported Event|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
133806|NCT01439724|E1|Reported Event|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
133807|NCT01439672|B1|Baseline|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
133808|NCT01439672|P1|Participant Flow|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
133809|NCT01439672|O1|Outcome|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
133825|NCT01439204|P2|Participant Flow|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133826|NCT01439204|P1|Participant Flow|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133919|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133810|NCT01439672|E1|Reported Event|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
133811|NCT01439282|B3|Baseline|Total|Total of all reporting groups
133812|NCT01439282|B2|Baseline|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133813|NCT01439282|B1|Baseline|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133814|NCT01439282|P2|Participant Flow|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133815|NCT01439282|P1|Participant Flow|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133816|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133817|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133818|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133819|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133820|NCT01439282|E2|Reported Event|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133821|NCT01439282|E1|Reported Event|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
133822|NCT01439204|B3|Baseline|Total|Total of all reporting groups
133823|NCT01439204|B2|Baseline|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133916|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133827|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133828|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133829|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133830|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133831|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133832|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133833|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133834|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133835|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133836|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133837|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133838|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133839|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133840|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133841|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133842|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133843|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133844|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133845|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133846|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133847|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133848|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133849|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133850|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133851|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133852|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133853|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133917|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133920|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133854|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133855|NCT01439204|E2|Reported Event|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133856|NCT01439204|E1|Reported Event|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
133857|NCT01439126|B3|Baseline|Total|Total of all reporting groups
133858|NCT01439126|B2|Baseline|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133859|NCT01439126|B1|Baseline|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133860|NCT01439126|P2|Participant Flow|Subjects on Placebo|"Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study~Of 67 Subjects randomized to Placebo:~26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day"
133861|NCT01439126|P1|Participant Flow|Subjects on KAPVAY (Clonidine Hydrochloride)|"Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.~All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.~Of 68 Subjects randomized to KAPVAY:~24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day"
133862|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133863|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133864|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133865|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133866|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133867|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133868|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133869|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133870|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133871|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133872|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133873|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133874|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133875|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133876|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133877|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133878|NCT01439126|E2|Reported Event|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
133879|NCT01439126|E1|Reported Event|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
133880|NCT01439074|B3|Baseline|Total|Total of all reporting groups
133881|NCT01439074|B2|Baseline|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133882|NCT01439074|B1|Baseline|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133883|NCT01439074|P2|Participant Flow|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133884|NCT01439074|P1|Participant Flow|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133885|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133886|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133887|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133888|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133889|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133890|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133891|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133892|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133893|NCT01439074|E2|Reported Event|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
133894|NCT01439074|E1|Reported Event|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
133895|NCT01438996|B4|Baseline|Total|Total of all reporting groups
133896|NCT01438996|B3|Baseline|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133897|NCT01438996|B2|Baseline|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133898|NCT01438996|B1|Baseline|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133899|NCT01438996|P3|Participant Flow|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133900|NCT01438996|P2|Participant Flow|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133901|NCT01438996|P1|Participant Flow|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133902|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133903|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133904|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133905|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133906|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133907|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133908|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133909|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133910|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133911|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133912|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133913|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133914|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133915|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
153769|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
133921|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133922|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133923|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133924|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133925|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133926|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133927|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133928|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133929|NCT01438996|E3|Reported Event|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
133930|NCT01438996|E2|Reported Event|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
133931|NCT01438996|E1|Reported Event|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
133932|NCT01438814|B3|Baseline|Total|Total of all reporting groups
133933|NCT01438814|B2|Baseline|Met Bid|Patients treated with metformin alone twice daily.
133934|NCT01438814|B1|Baseline|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133935|NCT01438814|P2|Participant Flow|Met Bid|Patients treated with metformin alone twice daily.
133936|NCT01438814|P1|Participant Flow|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133937|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133938|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133939|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133940|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133941|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133942|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133943|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133944|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133945|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133946|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133947|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133948|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133949|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133950|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133951|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133952|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133953|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133954|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133955|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133956|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133957|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133958|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133959|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133960|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133961|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
133962|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133963|NCT01438814|E2|Reported Event|Met Bid|Patients treated with metformin alone twice daily.
133964|NCT01438814|E1|Reported Event|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
133965|NCT01438710|B1|Baseline|Prograf|"Tacrolimus capsules for twice daily oral administration~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
133966|NCT01438710|P2|Participant Flow|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
133967|NCT01438710|P1|Participant Flow|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
134008|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
153770|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
133968|NCT01438710|O1|Outcome|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
133969|NCT01438710|E2|Reported Event|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
133970|NCT01438710|E1|Reported Event|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
133971|NCT01438541|B1|Baseline|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133972|NCT01438541|P1|Participant Flow|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133973|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133974|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133975|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133976|NCT01438541|E1|Reported Event|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
133977|NCT01438489|B4|Baseline|Total|Total of all reporting groups
133978|NCT01438489|B3|Baseline|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133979|NCT01438489|B2|Baseline|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133980|NCT01438489|B1|Baseline|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
133981|NCT01438489|P3|Participant Flow|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133982|NCT01438489|P2|Participant Flow|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133983|NCT01438489|P1|Participant Flow|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
133984|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133985|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133986|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133987|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133988|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133989|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133990|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133991|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133992|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133993|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133994|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
133995|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133996|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133997|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
133998|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
133999|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134000|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134001|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134002|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134003|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134004|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134005|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134006|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134007|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134009|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134010|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134011|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134012|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134013|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134014|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134015|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134016|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134017|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134018|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134019|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134020|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134021|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134022|NCT01438489|E3|Reported Event|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134023|NCT01438489|E2|Reported Event|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
134024|NCT01438489|E1|Reported Event|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
134025|NCT01438424|B1|Baseline|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134026|NCT01438424|P1|Participant Flow|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134027|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134028|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134029|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134030|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134031|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134032|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
134033|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134034|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134035|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134036|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134037|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
134038|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134039|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134040|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134041|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134042|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134043|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134138|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134044|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134045|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
134046|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
134047|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
134048|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134049|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
134050|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
134051|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134052|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134053|NCT01438424|E8|Reported Event|Placebo|Participants originally assigned to placebo before protocol change to study drug.
134054|NCT01438424|E7|Reported Event|Missing|Category missing
134055|NCT01438424|E6|Reported Event|Lamovidine, 100 mg|Participants originally received lamovidine with entecavir
134056|NCT01438424|E5|Reported Event|Entecavir, 1.0 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134057|NCT01438424|E4|Reported Event|Entecavir, 0.5 mg|Participants received entecavir QD with lamovidine
134058|NCT01438424|E3|Reported Event|Entecavir, 0.1 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134059|NCT01438424|E2|Reported Event|Entecavir, 0.02588 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
134060|NCT01438424|E1|Reported Event|Adefovir, 10 mg|Participants who received adefovir concomitantly at postdosing follow-up
134061|NCT01438294|B3|Baseline|Total|Total of all reporting groups
134062|NCT01438294|B2|Baseline|Video Game|"The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).~Video game group: The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge)."
134063|NCT01438294|B1|Baseline|Aerobic Exercise|"The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.~Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011)."
134064|NCT01438294|P2|Participant Flow|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
134065|NCT01438294|P1|Participant Flow|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
134066|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
134067|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
135226|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
134068|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
134069|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
134070|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
134071|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
134072|NCT01438294|E2|Reported Event|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
134073|NCT01438294|E1|Reported Event|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
134074|NCT01438229|B1|Baseline|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134075|NCT01438229|P1|Participant Flow|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134076|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134077|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134078|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134079|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134080|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134081|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134082|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134083|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134084|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134139|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134085|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134086|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134087|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134088|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134089|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134090|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134091|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134092|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134093|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134094|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134095|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134096|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134097|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134098|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134099|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134100|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134101|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134102|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134103|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134104|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134105|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134106|NCT01438229|E1|Reported Event|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
134107|NCT01438177|B1|Baseline|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
134108|NCT01438177|P1|Participant Flow|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
134109|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
153771|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
134110|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
134111|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
134112|NCT01438177|E1|Reported Event|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
134113|NCT01438151|B1|Baseline|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
134114|NCT01438151|P1|Participant Flow|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
134115|NCT01438151|O1|Outcome|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
134116|NCT01438151|E1|Reported Event|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
134117|NCT01438060|B3|Baseline|Total|Total of all reporting groups
134118|NCT01438060|B2|Baseline|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134119|NCT01438060|B1|Baseline|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
134120|NCT01438060|P2|Participant Flow|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134121|NCT01438060|P1|Participant Flow|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
134122|NCT01438060|O1|Outcome|Aripiprazole|Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).
134123|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134124|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134125|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134126|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134127|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134128|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134129|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134130|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134131|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134132|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
134133|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134134|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134135|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134136|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
134137|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134141|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134142|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134143|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134144|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134145|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134146|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134147|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134148|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134149|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134150|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134151|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134152|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134153|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134154|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134155|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134156|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134157|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134158|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134159|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134160|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134161|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134162|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134163|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134164|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134165|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134166|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134167|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134168|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134169|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134170|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134171|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134172|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134173|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134174|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134175|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134176|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134177|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134178|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134179|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134180|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134181|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134182|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134183|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134184|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134185|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134186|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134187|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134188|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134189|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134190|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134191|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134192|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134193|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
134194|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
134195|NCT01438060|E3|Reported Event|3 Ext - Aripiprazole|
134196|NCT01438060|E2|Reported Event|2 Double Blind Placebo|
134197|NCT01438060|E1|Reported Event|1 Double Blind Aripiprazole|
134198|NCT01437878|B3|Baseline|Total|Total of all reporting groups
134200|NCT01437878|B1|Baseline|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134201|NCT01437878|P2|Participant Flow|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134202|NCT01437878|P1|Participant Flow|Iloprost|"single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134203|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134204|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134205|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134206|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134207|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134208|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134209|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134210|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134211|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134212|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134213|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134214|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134215|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134216|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134217|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134218|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134219|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134220|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134221|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134222|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134223|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134224|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134225|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134226|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134227|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134228|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134229|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134230|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134231|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134232|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134233|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134234|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134235|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134236|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134237|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
134238|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134239|NCT01437878|E2|Reported Event|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
153772|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
134240|NCT01437878|E1|Reported Event|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
134241|NCT01437501|B3|Baseline|Total|Total of all reporting groups
134242|NCT01437501|B2|Baseline|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
134243|NCT01437501|B1|Baseline|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
134244|NCT01437501|P2|Participant Flow|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
134245|NCT01437501|P1|Participant Flow|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
134246|NCT01437501|O2|Outcome|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
134247|NCT01437501|O1|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
134248|NCT01437501|E2|Reported Event|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
134249|NCT01437501|E1|Reported Event|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
134250|NCT01437423|B1|Baseline|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134251|NCT01437423|P1|Participant Flow|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134252|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134253|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134254|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134255|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134256|NCT01437423|E1|Reported Event|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
134257|NCT01437319|B1|Baseline|Overall|The analysis population consists of all subjects that were enrolled into the study.
134258|NCT01437319|P3|Participant Flow|Balfilcon A|Subjects that received balafilcon A lens in Phase II.
134259|NCT01437319|P2|Participant Flow|Comfilcon A|Subjects that received comfilcon A lens in Phase II.
134260|NCT01437319|P1|Participant Flow|Lotrafilcon A|All subjects received lotrafilcon A in Phase I.
134261|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former
134262|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former
134263|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former.
134264|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former.
134265|NCT01437319|E3|Reported Event|Lotrafilcon A|All Subjects received lotrafilcon A in Phase I of the study.
134266|NCT01437319|E2|Reported Event|Balafilcon A|Subjects who received balafilcon A in Phase II of the study
134267|NCT01437319|E1|Reported Event|Comfilcon A|Subjects who received comfilcon A in Phase II of the study.
134268|NCT01437267|B7|Baseline|Total|Total of all reporting groups
134269|NCT01437267|B6|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134270|NCT01437267|B5|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134271|NCT01437267|B4|Baseline|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134272|NCT01437267|B3|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134273|NCT01437267|B2|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134274|NCT01437267|B1|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134275|NCT01437267|P6|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134276|NCT01437267|P5|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134277|NCT01437267|P4|Participant Flow|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134278|NCT01437267|P3|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134279|NCT01437267|P2|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134280|NCT01437267|P1|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134282|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134283|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134284|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134285|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134286|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134287|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134288|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134289|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134290|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134291|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134292|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134293|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134294|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134295|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134296|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134297|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134298|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134299|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134300|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134301|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134302|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134303|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134304|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134305|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134306|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134307|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134308|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134309|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134310|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134311|NCT01437267|E6|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
134312|NCT01437267|E5|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
134313|NCT01437267|E4|Reported Event|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
134314|NCT01437267|E3|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134315|NCT01437267|E2|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
134316|NCT01437267|E1|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
134317|NCT01437124|B1|Baseline|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
134318|NCT01437124|P1|Participant Flow|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
134319|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
134320|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
134321|NCT01437124|E1|Reported Event|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
134322|NCT01437111|B1|Baseline|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
134323|NCT01437111|P1|Participant Flow|Fosamax Plus: All Participants|All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
134324|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
134325|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134326|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134327|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134328|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
134329|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134330|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134331|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
134332|NCT01437111|E1|Reported Event|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
134333|NCT01437098|B1|Baseline|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
134334|NCT01437098|P1|Participant Flow|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
134335|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134336|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134337|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134338|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134339|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134340|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134341|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134342|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134343|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134344|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134345|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134346|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134347|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134348|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134349|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134350|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134351|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134352|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134353|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134354|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134355|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134356|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134357|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134358|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134359|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134360|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134361|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134362|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134363|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134364|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134365|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134366|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134367|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134368|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134369|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134370|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
134371|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
134372|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
134373|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
134374|NCT01437098|O1|Outcome|As Treated (AT) Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134375|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134376|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
134377|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134378|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134379|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134380|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134381|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134382|NCT01437098|O2|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134383|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
134384|NCT01437098|E4|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
134461|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
153850|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
134385|NCT01437098|E3|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.
134386|NCT01437098|E2|Reported Event|Subclavian (As Treated Subjects)|The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.
134387|NCT01437098|E1|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.
134388|NCT01436799|B3|Baseline|Total|Total of all reporting groups
134389|NCT01436799|B2|Baseline|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
134390|NCT01436799|B1|Baseline|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
134391|NCT01436799|P2|Participant Flow|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
134392|NCT01436799|P1|Participant Flow|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
134393|NCT01436799|O2|Outcome|Propofol|anesthetic maintanence with propofol
134394|NCT01436799|O1|Outcome|Desflurane|anesthetic maintenence with desflurane
134395|NCT01436799|E2|Reported Event|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
134396|NCT01436799|E1|Reported Event|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
134397|NCT01436643|B4|Baseline|Total|Total of all reporting groups
134398|NCT01436643|B3|Baseline|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
134399|NCT01436643|B2|Baseline|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
134400|NCT01436643|B1|Baseline|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
134401|NCT01436643|P4|Participant Flow|Pre-treatment With Fingolimod|During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
134402|NCT01436643|P3|Participant Flow|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
134403|NCT01436643|P2|Participant Flow|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
134404|NCT01436643|P1|Participant Flow|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
134405|NCT01436643|O4|Outcome|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
134406|NCT01436643|O3|Outcome|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
134407|NCT01436643|O2|Outcome|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
134408|NCT01436643|O1|Outcome|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
134409|NCT01436643|E4|Reported Event|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
134410|NCT01436643|E3|Reported Event|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
134411|NCT01436643|E2|Reported Event|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
134412|NCT01436643|E1|Reported Event|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
134413|NCT01436526|B3|Baseline|Total|Total of all reporting groups
134414|NCT01436526|B2|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
134462|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134415|NCT01436526|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
134416|NCT01436526|P2|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
134417|NCT01436526|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
134418|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134419|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134420|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134421|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134422|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134423|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134424|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134425|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134426|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134427|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134428|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134429|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134430|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134431|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134432|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
134433|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
134434|NCT01436526|E2|Reported Event|Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)|Single oral dose of 1*10 mg rivaroxaban tablet administered under fasting conditions
134435|NCT01436526|E1|Reported Event|Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)|Single oral dose of 2*5 mg rivaroxaban tablets administered under fasting conditions
134436|NCT01436500|B3|Baseline|Total|Total of all reporting groups
134437|NCT01436500|B2|Baseline|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134438|NCT01436500|B1|Baseline|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134439|NCT01436500|P2|Participant Flow|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134440|NCT01436500|P1|Participant Flow|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134441|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134442|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134443|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134444|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134445|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134446|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134447|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134448|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134449|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134450|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134451|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134452|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134453|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes
134454|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134455|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134456|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134457|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134458|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134459|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134460|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134463|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134464|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134465|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134466|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134467|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134468|NCT01436500|O1|Outcome|Ifetroban Injection|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134469|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134470|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134471|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134472|NCT01436500|O1|Outcome|Ifetroban Injection|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134473|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134474|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134475|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134476|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134477|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134478|NCT01436500|O1|Outcome|Ifetroban Injection|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134479|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134480|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134481|NCT01436500|O1|Outcome|Ifetroban Injection|5 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134482|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134483|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134484|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134485|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134486|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134487|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134488|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134489|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134490|NCT01436500|O1|Outcome|Ifetroban Injection|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134491|NCT01436500|E2|Reported Event|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
134492|NCT01436500|E1|Reported Event|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
134493|NCT01436435|B1|Baseline|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134494|NCT01436435|P1|Participant Flow|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134495|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134496|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134497|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134498|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134499|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134500|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134501|NCT01436435|E1|Reported Event|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
134502|NCT01436370|B9|Baseline|Total|Total of all reporting groups
134503|NCT01436370|B8|Baseline|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134764|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
134504|NCT01436370|B7|Baseline|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134505|NCT01436370|B6|Baseline|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134506|NCT01436370|B5|Baseline|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134507|NCT01436370|B4|Baseline|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134508|NCT01436370|B3|Baseline|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134509|NCT01436370|B2|Baseline|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134510|NCT01436370|B1|Baseline|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134511|NCT01436370|P8|Participant Flow|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134512|NCT01436370|P7|Participant Flow|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134513|NCT01436370|P6|Participant Flow|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134514|NCT01436370|P5|Participant Flow|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134515|NCT01436370|P4|Participant Flow|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134516|NCT01436370|P3|Participant Flow|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134517|NCT01436370|P2|Participant Flow|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134518|NCT01436370|P1|Participant Flow|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134519|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134520|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134521|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134522|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134523|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134524|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134525|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134526|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134527|NCT01436370|O4|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134528|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134529|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134530|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134531|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134532|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134533|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134534|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134535|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134536|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134537|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134538|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134539|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134540|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134541|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134542|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134543|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134544|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134545|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134546|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134547|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134548|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134549|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134550|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134551|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134552|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134553|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134554|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134555|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134556|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134557|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134558|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134559|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134560|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134561|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134562|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134563|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134564|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134565|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134566|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134567|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134568|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134569|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134570|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134571|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134572|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134573|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134574|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134575|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134576|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134577|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134578|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134579|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134580|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134581|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134582|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134583|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134584|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134585|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134586|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134587|NCT01436370|E8|Reported Event|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134588|NCT01436370|E7|Reported Event|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
134589|NCT01436370|E6|Reported Event|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134590|NCT01436370|E5|Reported Event|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
134591|NCT01436370|E4|Reported Event|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134592|NCT01436370|E3|Reported Event|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
134593|NCT01436370|E2|Reported Event|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134594|NCT01436370|E1|Reported Event|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
134595|NCT01436253|B1|Baseline|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
134596|NCT01436253|P1|Participant Flow|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
134597|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
134598|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
134599|NCT01436253|E1|Reported Event|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
134600|NCT01436201|B1|Baseline|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134601|NCT01436201|P1|Participant Flow|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134602|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134603|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
134604|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134605|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
134606|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134607|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
134608|NCT01436201|E2|Reported Event|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
134609|NCT01436201|E1|Reported Event|Digoxin|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
134610|NCT01436175|B1|Baseline|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134611|NCT01436175|P1|Participant Flow|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134612|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134613|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134614|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134615|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134616|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134617|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134618|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134619|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134620|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
153851|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
134621|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134622|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134623|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134624|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134625|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134626|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134627|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134628|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134629|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134630|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134631|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134632|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134633|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134634|NCT01436175|E1|Reported Event|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
134635|NCT01436162|B3|Baseline|Total|Total of all reporting groups
134636|NCT01436162|B2|Baseline|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
134637|NCT01436162|B1|Baseline|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose) for 8 weeks.
134638|NCT01436162|P3|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
134639|NCT01436162|P2|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose).
135227|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
134640|NCT01436162|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
134641|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
134642|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134643|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134644|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134645|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134646|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134647|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134648|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134649|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134650|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134651|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134652|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134653|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134654|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134655|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134656|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134657|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134658|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134659|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134660|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134661|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134662|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134663|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134664|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134665|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134666|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134667|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134668|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134669|NCT01436162|E2|Reported Event|Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
134670|NCT01436162|E1|Reported Event|SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate ): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
134671|NCT01436149|B3|Baseline|Total|Total of all reporting groups
134672|NCT01436149|B2|Baseline|Antidepressant + Double-blind SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
134673|NCT01436149|B1|Baseline|Antidepressant + Double-blind Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
134674|NCT01436149|P3|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
134675|NCT01436149|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
134676|NCT01436149|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
134677|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134678|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134679|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134680|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134681|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134682|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134683|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134684|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134685|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
135216|NCT01433250|P2|Participant Flow|AIN Placebo/ AIN457 Extension|"Placebo in core study and AIN in extension study~(10 mg/kg iv every four weeks)"
134686|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134687|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134688|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134689|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134690|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134691|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134692|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134693|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134694|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134695|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134696|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134697|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134698|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134699|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
134700|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
134701|NCT01436149|E2|Reported Event|Antidepressant + SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
134702|NCT01436149|E1|Reported Event|Antidepressant + Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
134703|NCT01436110|B4|Baseline|Total|Total of all reporting groups
134704|NCT01436110|B3|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134705|NCT01436110|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134706|NCT01436110|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134707|NCT01436110|P3|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134708|NCT01436110|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134709|NCT01436110|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134710|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134711|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134712|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134713|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134714|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134715|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134716|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134717|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134718|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134719|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134720|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134721|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134722|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134723|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134724|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134725|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134726|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134727|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134728|NCT01436110|E3|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134729|NCT01436110|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134730|NCT01436110|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134731|NCT01436084|B1|Baseline|SB1518|400 mg orally a day for 28 day cycle.
134732|NCT01436084|P1|Participant Flow|SB1518|400 mg orally a day for 28 day cycle.
134733|NCT01436084|O1|Outcome|SB1518|400 mg orally a day for 28 day cycle.
134734|NCT01436084|E1|Reported Event|SB1518|400 mg orally a day for 28 day cycle.
134735|NCT01436071|B3|Baseline|Total|Total of all reporting groups
134765|NCT01436045|E1|Reported Event|All Study Partipants|Participants who received either intranasal glulisine (0.10 mL in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
134736|NCT01436071|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134737|NCT01436071|B1|Baseline|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134738|NCT01436071|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134739|NCT01436071|P1|Participant Flow|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134740|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134741|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134742|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134743|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134744|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134745|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134746|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134747|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134748|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134749|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134750|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134751|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134752|NCT01436071|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134753|NCT01436071|E1|Reported Event|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
134754|NCT01436045|B1|Baseline|All Study Partipants|Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
134755|NCT01436045|P2|Participant Flow|Placebo, Then Insulin Glulisine|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
134756|NCT01436045|P1|Participant Flow|Insulin Glulisine, Then Placebo|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
134757|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
134758|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
134759|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
134760|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
134761|NCT01436045|O2|Outcome|Post Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
134762|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
134763|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
134767|NCT01436006|P1|Participant Flow|CT Scan|"A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT.~A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies."
134768|NCT01436006|O1|Outcome|CT Adult Spine|Adult patients submitted to spine CT
134769|NCT01436006|O1|Outcome|Adult Patient Chest Abdomen and Pelvis|Adult patients submitted to chest abdomen and pelvis CT examinations.
134770|NCT01436006|O1|Outcome|Adult Cardiac CT|Adult patients submitted to cardiac CT
134771|NCT01436006|O2|Outcome|Abdomen CT Pediatric|Pediatric patients submitted to abdomen CT
134772|NCT01436006|O1|Outcome|Abdomen CT Adults|Adult patients submitted to abdomen CT
134773|NCT01436006|O2|Outcome|Chest CT- Pediatric|Pediatric patients submitted to chest CT
134774|NCT01436006|O1|Outcome|Chest CT- Adult|Adult patients submitted to chest CT
134775|NCT01436006|O2|Outcome|Pediatric|Pediatric patients submitted to head CT scan
134776|NCT01436006|O1|Outcome|Adult|Adult patients submitted to head CT scan
134777|NCT01436006|E1|Reported Event|Adverse Reaction to CT|Patients submitted to CT
134778|NCT01435928|B3|Baseline|Total|Total of all reporting groups
134779|NCT01435928|B2|Baseline|Placebo|During double blind phase subjects received matching placebo.
134780|NCT01435928|B1|Baseline|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
134781|NCT01435928|P3|Participant Flow|Placebo|During double blind phase subjects received matching placebo.
134782|NCT01435928|P2|Participant Flow|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
134783|NCT01435928|P1|Participant Flow|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
134784|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134785|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134786|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134787|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134788|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134789|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134790|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134791|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134792|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134793|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134794|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134795|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134796|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134797|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134798|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134799|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134800|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134801|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134802|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
134803|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134804|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
153852|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
134805|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
134806|NCT01435928|E3|Reported Event|Placebo|During double blind phase subjects received matching placebo.
134807|NCT01435928|E2|Reported Event|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
134808|NCT01435928|E1|Reported Event|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
134809|NCT01435759|B6|Baseline|Total|Total of all reporting groups
134810|NCT01435759|B5|Baseline|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134811|NCT01435759|B4|Baseline|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134812|NCT01435759|B3|Baseline|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134813|NCT01435759|B2|Baseline|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134814|NCT01435759|B1|Baseline|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134815|NCT01435759|P6|Participant Flow|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134816|NCT01435759|P5|Participant Flow|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134817|NCT01435759|P4|Participant Flow|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134818|NCT01435759|P3|Participant Flow|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134819|NCT01435759|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134820|NCT01435759|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
134821|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134822|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134823|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134824|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134825|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134826|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134827|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134828|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134829|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134857|NCT01435655|E1|Reported Event|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134830|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134831|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134832|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134833|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134834|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134835|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134836|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134837|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134838|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134839|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134840|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134841|NCT01435759|E5|Reported Event|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
134842|NCT01435759|E4|Reported Event|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
134843|NCT01435759|E3|Reported Event|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
134844|NCT01435759|E2|Reported Event|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
134845|NCT01435759|E1|Reported Event|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
134846|NCT01435655|B1|Baseline|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134847|NCT01435655|P1|Participant Flow|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134848|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134849|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134850|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134851|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134852|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134853|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134854|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134855|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134856|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
134858|NCT01435577|B3|Baseline|Total|Total of all reporting groups
153853|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
134859|NCT01435577|B2|Baseline|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134860|NCT01435577|B1|Baseline|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134861|NCT01435577|P2|Participant Flow|Matching Placebo Intravenous|"Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.~65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
134862|NCT01435577|P1|Participant Flow|Tapentadol Intravenous|"Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.~64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
134863|NCT01435577|O1|Outcome|Matching Placebo Intravenous|Matching Placebo will be given by intravenous infusion. Matching Placebo will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134864|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134865|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
134866|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134867|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134868|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
134869|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone. Values collected after 12 hours were censored, i.e. participants scored as having no meaningful pain relief.
134870|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134871|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134872|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134873|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134874|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134875|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134876|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134877|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134878|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134879|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134880|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134881|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134882|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134883|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134884|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134885|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134886|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134887|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134888|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134889|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134890|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134891|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134892|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134893|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134894|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134895|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134896|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134897|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134898|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134899|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134900|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134901|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134902|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134903|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134904|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134905|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134906|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
134907|NCT01435577|E2|Reported Event|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
134908|NCT01435577|E1|Reported Event|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
134909|NCT01435460|B3|Baseline|Total|Total of all reporting groups
134910|NCT01435460|B2|Baseline|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134911|NCT01435460|B1|Baseline|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134912|NCT01435460|P2|Participant Flow|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134913|NCT01435460|P1|Participant Flow|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134914|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134915|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134916|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134917|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134918|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134919|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134920|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134921|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134922|NCT01435460|E2|Reported Event|Patanol|Ophthalmic solution containing olopatadine, 0.1%
134923|NCT01435460|E1|Reported Event|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
134924|NCT01435265|B3|Baseline|Total|Total of all reporting groups
134925|NCT01435265|B2|Baseline|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134926|NCT01435265|B1|Baseline|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134927|NCT01435265|P2|Participant Flow|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134928|NCT01435265|P1|Participant Flow|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134929|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134930|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134931|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134932|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134933|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134934|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134935|NCT01435265|E2|Reported Event|Additional Nurse Education|Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
134936|NCT01435265|E1|Reported Event|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
134937|NCT01435174|B1|Baseline|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
134938|NCT01435174|P1|Participant Flow|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
134939|NCT01435174|O1|Outcome|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
134940|NCT01435174|E1|Reported Event|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
134941|NCT01435031|B1|Baseline|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134942|NCT01435031|P1|Participant Flow|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134943|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134944|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134945|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134946|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134947|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135055|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
135228|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
134948|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134949|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134950|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134951|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134952|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134953|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134954|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134955|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134956|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134957|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134958|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134959|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135056|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
134960|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134961|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134962|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134963|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134964|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134965|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134966|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134967|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134968|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134969|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134970|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134971|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135057|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
153854|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
134972|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134973|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134974|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134975|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134976|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134977|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134978|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134979|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134980|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134981|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134982|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134983|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135058|NCT01434680|E4|Reported Event|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
134984|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134985|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134986|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134987|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134988|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134989|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134990|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134991|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134992|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134993|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134994|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134995|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135059|NCT01434680|E3|Reported Event|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
134996|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134997|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134998|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
134999|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135000|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135001|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135002|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135003|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135004|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135005|NCT01435031|E1|Reported Event|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
135006|NCT01434823|B3|Baseline|Total|Total of all reporting groups
135007|NCT01434823|B2|Baseline|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135008|NCT01434823|B1|Baseline|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135009|NCT01434823|P2|Participant Flow|Control - Standard of Care|"The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay."
135060|NCT01434680|E2|Reported Event|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
135061|NCT01434680|E1|Reported Event|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
135062|NCT01434654|B3|Baseline|Total|Total of all reporting groups
135010|NCT01434823|P1|Participant Flow|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay in secondary analyses."
135011|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135012|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135013|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135014|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135015|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135016|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135017|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135018|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135019|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135020|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135021|NCT01434823|E2|Reported Event|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
135022|NCT01434823|E1|Reported Event|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
135023|NCT01434693|B5|Baseline|Total|Total of all reporting groups
135024|NCT01434693|B4|Baseline|TSO 7500|Trichuris suis ova : single dose
135025|NCT01434693|B3|Baseline|TSO 2500|Trichuris suis ova : single dose
135026|NCT01434693|B2|Baseline|TSO 500|Trichuris suis ova : single dose
135027|NCT01434693|B1|Baseline|Placebo|Placebo: single dose
135028|NCT01434693|P4|Participant Flow|TSO 7500|Trichuris suis ova : single dose
135029|NCT01434693|P3|Participant Flow|TSO 2500|Trichuris suis ova : single dose
135030|NCT01434693|P2|Participant Flow|TSO 500|Trichuris suis ova : single dose
135031|NCT01434693|P1|Participant Flow|Placebo|Placebo: single dose
135032|NCT01434693|O4|Outcome|TSO 7500|Trichuris suis ova : single dose
135033|NCT01434693|O3|Outcome|TSO 2500|Trichuris suis ova : single dose
135034|NCT01434693|O2|Outcome|TSO 500|Trichuris suis ova : single dose
135035|NCT01434693|O1|Outcome|Placebo|Placebo: single dose
135036|NCT01434693|E4|Reported Event|TSO 7500|Trichuris suis ova : single dose
135037|NCT01434693|E3|Reported Event|TSO 2500|Trichuris suis ova : single dose
135038|NCT01434693|E2|Reported Event|TSO 500|Trichuris suis ova : single dose
135039|NCT01434693|E1|Reported Event|Placebo|Placebo: single dose
135040|NCT01434680|B5|Baseline|Total|Total of all reporting groups
135041|NCT01434680|B4|Baseline|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
135042|NCT01434680|B3|Baseline|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
135043|NCT01434680|B2|Baseline|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
135044|NCT01434680|B1|Baseline|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
135045|NCT01434680|P4|Participant Flow|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
135046|NCT01434680|P3|Participant Flow|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
135047|NCT01434680|P2|Participant Flow|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
135048|NCT01434680|P1|Participant Flow|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
135049|NCT01434680|O4|Outcome|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
135050|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
135051|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
135052|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
135053|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
135054|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
135063|NCT01434654|B2|Baseline|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135064|NCT01434654|B1|Baseline|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135065|NCT01434654|P2|Participant Flow|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135066|NCT01434654|P1|Participant Flow|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135067|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135068|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135069|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135070|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135071|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135072|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135073|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135074|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135075|NCT01434654|E2|Reported Event|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135076|NCT01434654|E1|Reported Event|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
135077|NCT01434641|B1|Baseline|Myocardial Perfusion SPECT|The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
135078|NCT01434641|P1|Participant Flow|Stress/Rest Myocardial Perfusion SPECT Patients|All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
135079|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
135217|NCT01433250|P1|Participant Flow|AIN457 Core / AIN457 Extension|AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
135080|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
135081|NCT01434641|E1|Reported Event|Myocardial Perfusion SPECT|
135082|NCT01434511|B1|Baseline|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135083|NCT01434511|P1|Participant Flow|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135084|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135085|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135086|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135087|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135088|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135089|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135090|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135091|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135092|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135093|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135094|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135095|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135096|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135097|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135098|NCT01434511|E1|Reported Event|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
135099|NCT01434121|B4|Baseline|Total|Total of all reporting groups
135100|NCT01434121|B3|Baseline|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135101|NCT01434121|B2|Baseline|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135102|NCT01434121|B1|Baseline|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135103|NCT01434121|P3|Participant Flow|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135104|NCT01434121|P2|Participant Flow|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135105|NCT01434121|P1|Participant Flow|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135106|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135107|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135108|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135109|NCT01434121|E3|Reported Event|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135110|NCT01434121|E2|Reported Event|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135111|NCT01434121|E1|Reported Event|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
135112|NCT01434030|B1|Baseline|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
135113|NCT01434030|P1|Participant Flow|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
135145|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135218|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
135114|NCT01434030|O1|Outcome|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
135115|NCT01434030|O1|Outcome|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
135116|NCT01434030|E1|Reported Event|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
135117|NCT01433913|B3|Baseline|Total|Total of all reporting groups
135118|NCT01433913|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
135119|NCT01433913|B1|Baseline|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
135120|NCT01433913|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
135121|NCT01433913|P1|Participant Flow|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
135122|NCT01433913|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
135123|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
135124|NCT01433913|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
135125|NCT01433913|E1|Reported Event|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
135126|NCT01433731|B5|Baseline|Total|Total of all reporting groups
135127|NCT01433731|B4|Baseline|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
135128|NCT01433731|B3|Baseline|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
135129|NCT01433731|B2|Baseline|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
135130|NCT01433731|B1|Baseline|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
135131|NCT01433731|P4|Participant Flow|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
135132|NCT01433731|P3|Participant Flow|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
135133|NCT01433731|P2|Participant Flow|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
135134|NCT01433731|P1|Participant Flow|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
135135|NCT01433731|O2|Outcome|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
135136|NCT01433731|O1|Outcome|SHAPE (SHP-141)|"Histone deacetylase inhibitor~SHAPE (SHP-141): topical gel"
135137|NCT01433731|E4|Reported Event|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
135138|NCT01433731|E3|Reported Event|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
135139|NCT01433731|E2|Reported Event|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
135140|NCT01433731|E1|Reported Event|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
135141|NCT01433549|B1|Baseline|Overall|Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135142|NCT01433549|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135143|NCT01433549|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135144|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135146|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135147|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135148|NCT01433549|E2|Reported Event|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135149|NCT01433549|E1|Reported Event|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
135150|NCT01433471|B3|Baseline|Total|Total of all reporting groups
135151|NCT01433471|B2|Baseline|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135152|NCT01433471|B1|Baseline|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135153|NCT01433471|P2|Participant Flow|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135154|NCT01433471|P1|Participant Flow|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135155|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135156|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135157|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135158|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135159|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135160|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135161|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135162|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135163|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135164|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
135165|NCT01433471|O2|Outcome|Placebo|
135166|NCT01433471|O1|Outcome|Trichuris Suis Ova|
135167|NCT01433471|E2|Reported Event|Placebo|
135168|NCT01433471|E1|Reported Event|Trichuris Suis Ova|
135169|NCT01433354|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
135170|NCT01433354|P1|Participant Flow|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
135171|NCT01433354|O6|Outcome|AFQ056 100 mg Bid|
135172|NCT01433354|O5|Outcome|AFQ056 75 mg Bid|
135173|NCT01433354|O4|Outcome|AFQ056 50 mg Bid|
135174|NCT01433354|O3|Outcome|AFQ056 25 mg Bid|
135175|NCT01433354|O2|Outcome|Prior to Ext. First Dose|
135176|NCT01433354|O1|Outcome|AFQ056|Total
135177|NCT01433354|E6|Reported Event|Total|Total
135178|NCT01433354|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
135179|NCT01433354|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
135180|NCT01433354|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
135181|NCT01433354|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
135182|NCT01433354|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
135183|NCT01433263|B3|Baseline|Total|Total of all reporting groups
135184|NCT01433263|B2|Baseline|Placebo / Late 30mg/kg BYM338|
135185|NCT01433263|B1|Baseline|30mg/kg BYM338|
135186|NCT01433263|P2|Participant Flow|Placebo / Late 30mg/kg BYM338|
135187|NCT01433263|P1|Participant Flow|30mg/kg BYM338|
135188|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
135189|NCT01433263|O1|Outcome|30mg/kg BYM338|
135190|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
135191|NCT01433263|O1|Outcome|30mg/kg BYM338|
135192|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
135193|NCT01433263|O1|Outcome|30mg/kg BYM338|
135229|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
135230|NCT01433250|E2|Reported Event|AIN457(Core)/AIN457(Extension)|AIN457(core)/AIN457(extension)
135231|NCT01433250|E1|Reported Event|Placebo(Core)/AIN457(Extension)|Placebo(core)/AIN457(extension)
135232|NCT01433159|B3|Baseline|Total|Total of all reporting groups
135233|NCT01433159|B2|Baseline|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
135234|NCT01433159|B1|Baseline|HP011-101|Xenaderm Ointment
135235|NCT01433159|P2|Participant Flow|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
135236|NCT01433159|P1|Participant Flow|HP011-101|Xenaderm Ointment
135237|NCT01433159|O2|Outcome|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
135238|NCT01433159|O1|Outcome|HP011-101|Xenaderm Ointment
135239|NCT01433159|E2|Reported Event|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
135240|NCT01433159|E1|Reported Event|HP011-101|Xenaderm Ointment
135241|NCT01433107|B3|Baseline|Total|Total of all reporting groups
135242|NCT01433107|B2|Baseline|Placebo|Drug
135243|NCT01433107|B1|Baseline|Terbinafine|Drug
135244|NCT01433107|P2|Participant Flow|Placebo|Drug
135245|NCT01433107|P1|Participant Flow|Terbinafine|Drug
135246|NCT01433107|O2|Outcome|Placebo|Drug
135247|NCT01433107|O1|Outcome|Terbinafine|Drug
135248|NCT01433107|O2|Outcome|Placebo|Drug
135249|NCT01433107|O1|Outcome|Terbinafine|Drug
135250|NCT01433107|O2|Outcome|Placebo|Drug
135251|NCT01433107|O1|Outcome|Terbinafine|Drug
135252|NCT01433107|E2|Reported Event|Placebo|Drug
135253|NCT01433107|E1|Reported Event|Terbinafine|Drug
135254|NCT01433081|B3|Baseline|Total|Total of all reporting groups
135255|NCT01433081|B2|Baseline|Placebo|.9 normal saline infusion
135256|NCT01433081|B1|Baseline|Magnesium Sulfate Infusion|Administration of magnesium suflate
135257|NCT01433081|P2|Participant Flow|Placebo|Normal saline infusion
135258|NCT01433081|P1|Participant Flow|Magnesium Sulfate Infusion|Administration of magnesium suflate
135259|NCT01433081|O2|Outcome|Placebo|.9 normal saline infusion
135260|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
135261|NCT01433081|O2|Outcome|Placebo|Normal saline infusion
135262|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
135263|NCT01433081|E2|Reported Event|Placebo|.9 normal saline infusion
135264|NCT01433081|E1|Reported Event|Magnesium Sulfate Infusion|Administration of magnesium suflate
135265|NCT01433042|B1|Baseline|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
135266|NCT01433042|P1|Participant Flow|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
135267|NCT01433042|O1|Outcome|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
135268|NCT01433042|E1|Reported Event|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
135269|NCT01433016|B1|Baseline|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
135270|NCT01433016|P1|Participant Flow|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
135271|NCT01433016|O1|Outcome|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
135272|NCT01433016|E1|Reported Event|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
135273|NCT01432938|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (dulaglutide or warfarin).
135274|NCT01432938|P2|Participant Flow|Dulaglutide + Warfarin First, Then Warfarin|"First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).~There was a washout period of at least 24 days between intervention periods.~Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1)."
135275|NCT01432938|P1|Participant Flow|Warfarin First, Then Dulaglutide + Warfarin|"First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).~There was a washout period of at least 24 days between treatment periods.~Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2)."
135276|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
135277|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
135278|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
135279|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
135280|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
135281|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
135474|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135282|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
135283|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
135284|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
135285|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
135286|NCT01432938|E3|Reported Event|Dulaglutide + Warfarin|"A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2~Timeframe: After dosing of warfarin on Day 3 of Treatment 2"
135287|NCT01432938|E2|Reported Event|Dulaglutide Alone|"A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.~Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2"
135288|NCT01432938|E1|Reported Event|Warfarin Alone|"A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.~Timeframe: Treatment 1"
135289|NCT01432886|B3|Baseline|Total|Total of all reporting groups
135290|NCT01432886|B2|Baseline|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
135291|NCT01432886|B1|Baseline|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
135292|NCT01432886|P2|Participant Flow|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
135293|NCT01432886|P1|Participant Flow|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
135294|NCT01432886|O2|Outcome|E7389 With Triweekly Trastuzumab|"Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.~Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses."
135295|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
135296|NCT01432886|O2|Outcome|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
135297|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
135298|NCT01432886|E2|Reported Event|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
135299|NCT01432886|E1|Reported Event|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
135300|NCT01432756|B5|Baseline|Total|Total of all reporting groups
135301|NCT01432756|B4|Baseline|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
135302|NCT01432756|B3|Baseline|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
135303|NCT01432756|B2|Baseline|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
135304|NCT01432756|B1|Baseline|Wait-list Control - Parent Participants|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
135337|NCT01432535|P1|Participant Flow|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135338|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135305|NCT01432756|P4|Participant Flow|Let's Talk Worksite Parenting Program - Adolescent Participant|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
135306|NCT01432756|P3|Participant Flow|Wait-list Control - Adolescent Partipants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
135307|NCT01432756|P2|Participant Flow|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
135308|NCT01432756|P1|Participant Flow|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
135309|NCT01432756|O4|Outcome|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
135310|NCT01432756|O3|Outcome|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
135311|NCT01432756|O2|Outcome|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
135312|NCT01432756|O1|Outcome|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
135313|NCT01432756|E2|Reported Event|Let's Talk Worskite Parenting Program|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
135314|NCT01432756|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
135315|NCT01432626|B1|Baseline|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
135339|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135340|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135341|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135316|NCT01432626|P1|Participant Flow|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
135317|NCT01432626|O1|Outcome|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
135318|NCT01432626|E1|Reported Event|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
135319|NCT01432574|B1|Baseline|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
135320|NCT01432574|P1|Participant Flow|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
135321|NCT01432574|O2|Outcome|Gardasil Vaccine - Month 7|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
135322|NCT01432574|O1|Outcome|Gardasil Vaccine - Day 1|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
135323|NCT01432574|O1|Outcome|Gardasil Vaccine - Month 7|
135324|NCT01432574|E1|Reported Event|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
135325|NCT01432561|B1|Baseline|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
135326|NCT01432561|P1|Participant Flow|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
135327|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
135328|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
135329|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
135330|NCT01432561|E1|Reported Event|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
135331|NCT01432535|B4|Baseline|Total|Total of all reporting groups
135332|NCT01432535|B3|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135333|NCT01432535|B2|Baseline|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135334|NCT01432535|B1|Baseline|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135335|NCT01432535|P3|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135336|NCT01432535|P2|Participant Flow|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135632|NCT01431521|B4|Baseline|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
135342|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135343|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135344|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135345|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135346|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135347|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135348|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135349|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135350|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135351|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135352|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135353|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135354|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135355|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135356|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135357|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135358|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135359|NCT01432535|E3|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135360|NCT01432535|E2|Reported Event|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135361|NCT01432535|E1|Reported Event|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
135362|NCT01432457|B4|Baseline|Total|Total of all reporting groups
135363|NCT01432457|B3|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135364|NCT01432457|B2|Baseline|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135365|NCT01432457|B1|Baseline|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135366|NCT01432457|P3|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135367|NCT01432457|P2|Participant Flow|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135368|NCT01432457|P1|Participant Flow|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135633|NCT01431521|B3|Baseline|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135369|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135370|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135371|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135372|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135373|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135374|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135375|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135376|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135377|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135378|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135379|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135380|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135381|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135382|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135383|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135384|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135385|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135386|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135387|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135388|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135389|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135390|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135391|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135392|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135393|NCT01432457|E3|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
135394|NCT01432457|E2|Reported Event|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
135395|NCT01432457|E1|Reported Event|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
135406|NCT01432444|E2|Reported Event|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
153855|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
135396|NCT01432444|B1|Baseline|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135397|NCT01432444|P3|Participant Flow|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
135398|NCT01432444|P2|Participant Flow|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135399|NCT01432444|P1|Participant Flow|Tolerability/Cross-titration Phase (Phase A)|In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
135400|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135401|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135402|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135403|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135404|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135405|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135437|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
153856|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
135407|NCT01432444|E1|Reported Event|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
135408|NCT01432405|B3|Baseline|Total|Total of all reporting groups
135409|NCT01432405|B2|Baseline|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135410|NCT01432405|B1|Baseline|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135411|NCT01432405|P2|Participant Flow|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135412|NCT01432405|P1|Participant Flow|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135413|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135414|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135415|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135416|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135438|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135417|NCT01432405|E2|Reported Event|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135418|NCT01432405|E1|Reported Event|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
135419|NCT01432379|B1|Baseline|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
135420|NCT01432379|P1|Participant Flow|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
135421|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
135422|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
135423|NCT01432379|E1|Reported Event|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
135424|NCT01432366|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135425|NCT01432366|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135426|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135427|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135428|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135429|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135430|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135431|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135432|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135433|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135434|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135435|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135436|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
153857|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
135439|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135440|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135441|NCT01432366|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
135442|NCT01432327|B5|Baseline|Total|Total of all reporting groups
135443|NCT01432327|B4|Baseline|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
135444|NCT01432327|B3|Baseline|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
135445|NCT01432327|B2|Baseline|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
135446|NCT01432327|B1|Baseline|Control Group|This group receives no kind of feedback during the intervention period
135447|NCT01432327|P4|Participant Flow|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
135448|NCT01432327|P3|Participant Flow|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
135449|NCT01432327|P2|Participant Flow|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
135450|NCT01432327|P1|Participant Flow|Control Group|This group receives no kind of feedback during the intervention period
135451|NCT01432327|O4|Outcome|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
135452|NCT01432327|O3|Outcome|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
135453|NCT01432327|O2|Outcome|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
135454|NCT01432327|O1|Outcome|Control Group|This group receives no kind of feedback during the intervention period
135455|NCT01432327|E4|Reported Event|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
135456|NCT01432327|E3|Reported Event|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
135457|NCT01432327|E2|Reported Event|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
135458|NCT01432327|E1|Reported Event|Control Group|This group receives no kind of feedback during the intervention period
135459|NCT01432262|B3|Baseline|Total|Total of all reporting groups
135460|NCT01432262|B2|Baseline|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135461|NCT01432262|B1|Baseline|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135462|NCT01432262|P2|Participant Flow|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135463|NCT01432262|P1|Participant Flow|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135464|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135465|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135466|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135467|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135468|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135469|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135470|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135471|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135472|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135473|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
136898|NCT01426789|P1|Participant Flow|Secukinumab|10 mg/kg intravenous (I.V.)
135475|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135476|NCT01432262|E2|Reported Event|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
135477|NCT01432262|E1|Reported Event|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
135478|NCT01432236|B3|Baseline|Total|Total of all reporting groups
135479|NCT01432236|B2|Baseline|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135480|NCT01432236|B1|Baseline|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135481|NCT01432236|P2|Participant Flow|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135482|NCT01432236|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135483|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
135484|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
135485|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
135486|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135487|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135488|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135489|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135490|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135491|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135492|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135634|NCT01431521|B2|Baseline|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
135493|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135494|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135495|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135496|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135497|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135498|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135499|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135500|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135501|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135502|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135503|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135504|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135517|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135505|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135506|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135507|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135508|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135509|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135510|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135511|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135512|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135513|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135514|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135515|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135516|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135635|NCT01431521|B1|Baseline|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135518|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135519|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135520|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
135521|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135522|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135523|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135524|NCT01432236|E2|Reported Event|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
135525|NCT01432236|E1|Reported Event|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
135526|NCT01432015|B3|Baseline|Total|Total of all reporting groups
135527|NCT01432015|B2|Baseline|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
135528|NCT01432015|B1|Baseline|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
135529|NCT01432015|P2|Participant Flow|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
135530|NCT01432015|P1|Participant Flow|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3. Patient will receive standard pre-medications on day 1
135531|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
136899|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
135532|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
135533|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
135534|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
135535|NCT01432015|E2|Reported Event|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
135536|NCT01432015|E1|Reported Event|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
135537|NCT01431989|B1|Baseline|Participants Receiving Both Test and Reference Products|Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
135538|NCT01431989|P2|Participant Flow|Reference Product in Period 1: Test Product in Period 2|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
135539|NCT01431989|P1|Participant Flow|Test Product in Period 1: Reference Product in Period 2|Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
135540|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135541|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135542|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135543|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135544|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135545|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135546|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135547|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135548|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135549|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135550|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135551|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135552|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135553|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
135554|NCT01431989|E2|Reported Event|Reference Product in Period 1 and Test Product in Period 2|Reference product: Amoxil 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product: Clamoxyl 500 mg/5 mL in Period 2
135555|NCT01431989|E1|Reported Event|Test Product in Period 1 and Reference Product in Period 2|Test product: Amoxicillin powder for oral suspension (Clamoxyl) 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product; Amoxil 50 mg/5 mL in Period 2
135636|NCT01431521|P4|Participant Flow|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
135637|NCT01431521|P3|Participant Flow|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135638|NCT01431521|P2|Participant Flow|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
135556|NCT01431976|B1|Baseline|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135557|NCT01431976|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135558|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135559|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135560|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135561|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135562|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135563|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135639|NCT01431521|P1|Participant Flow|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135723|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135564|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135565|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135566|NCT01431976|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
135567|NCT01431963|B1|Baseline|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135568|NCT01431963|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135569|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135570|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135605|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135640|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
136900|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
135571|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135572|NCT01431963|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
135573|NCT01431950|B3|Baseline|Total|Total of all reporting groups
135574|NCT01431950|B2|Baseline|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135575|NCT01431950|B1|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135576|NCT01431950|P2|Participant Flow|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135577|NCT01431950|P1|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135578|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135579|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135580|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135581|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135582|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135583|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135584|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135585|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135586|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135587|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135588|NCT01431950|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135589|NCT01431950|E1|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
135590|NCT01431846|B4|Baseline|Total|Total of all reporting groups
135606|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135591|NCT01431846|B3|Baseline|Arm 3|"Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention~Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical att"
135592|NCT01431846|B2|Baseline|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
135593|NCT01431846|B1|Baseline|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
135594|NCT01431846|P3|Participant Flow|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
135595|NCT01431846|P2|Participant Flow|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
135596|NCT01431846|P1|Participant Flow|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
135597|NCT01431846|O3|Outcome|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2)medications reconciled between pre and post-hospital discharge; 3)discharge summary available to PCP at time of visit; and 4)patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
135598|NCT01431846|O2|Outcome|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
135599|NCT01431846|O1|Outcome|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
135600|NCT01431846|E3|Reported Event|Intervention|Total number at risk was 8. Zero adverse events were seen.
135601|NCT01431846|E2|Reported Event|Providers|Total number at risk was 3. Zero adverse events were seen.
135602|NCT01431846|E1|Reported Event|Discharged Patients|Total number at risk was 8. Zero adverse events were seen.
135603|NCT01431755|B1|Baseline|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
135604|NCT01431755|P1|Participant Flow|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135631|NCT01431521|B5|Baseline|Total|Total of all reporting groups
135607|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135608|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135609|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135610|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
135611|NCT01431755|E3|Reported Event|Restylane SubQ Lidocaine: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
135612|NCT01431755|E2|Reported Event|Restylane SubQ: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
135613|NCT01431755|E1|Reported Event|Restylane SubQ/Restylane SubQ Lidocaine: Systemic|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
135614|NCT01431716|B1|Baseline|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135615|NCT01431716|P1|Participant Flow|Epoprostenol for Injection (EFI/ACT-385781A)|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135616|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135617|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135618|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135619|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135620|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135621|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135622|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135623|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135624|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135625|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135626|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135627|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135628|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135629|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135630|NCT01431716|E1|Reported Event|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
135641|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135642|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135643|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
135644|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135645|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135646|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
135647|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135648|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135649|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
135650|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135651|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135652|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
135653|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
135654|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135655|NCT01431521|E4|Reported Event|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
135656|NCT01431521|E3|Reported Event|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
135657|NCT01431521|E2|Reported Event|Placebo for MK-4074|Participants will receive oral doses of placebo matching MK-4074 twice daily for 4 weeks.
135658|NCT01431521|E1|Reported Event|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
135659|NCT01431508|B1|Baseline|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
135660|NCT01431508|P1|Participant Flow|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
135661|NCT01431508|O1|Outcome|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
135662|NCT01431508|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|
135663|NCT01431339|B3|Baseline|Total|Total of all reporting groups
135664|NCT01431339|B2|Baseline|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135665|NCT01431339|B1|Baseline|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135666|NCT01431339|P2|Participant Flow|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135667|NCT01431339|P1|Participant Flow|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135668|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135669|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135670|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135671|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135672|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135673|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135674|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135675|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135676|NCT01431339|E2|Reported Event|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
135677|NCT01431339|E1|Reported Event|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
135678|NCT01431300|B4|Baseline|Total|Total of all reporting groups
135679|NCT01431300|B3|Baseline|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
135680|NCT01431300|B2|Baseline|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135681|NCT01431300|B1|Baseline|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135722|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135682|NCT01431300|P3|Participant Flow|0.03 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging
135683|NCT01431300|P2|Participant Flow|0.02 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
135684|NCT01431300|P1|Participant Flow|0.01 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
135685|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
135686|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135687|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135688|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
135689|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135690|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135691|NCT01431300|E3|Reported Event|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
135692|NCT01431300|E2|Reported Event|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135693|NCT01431300|E1|Reported Event|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
135694|NCT01431287|B6|Baseline|Total|Total of all reporting groups
135695|NCT01431287|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135696|NCT01431287|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135697|NCT01431287|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135698|NCT01431287|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135699|NCT01431287|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135700|NCT01431287|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135701|NCT01431287|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135702|NCT01431287|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135703|NCT01431287|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135704|NCT01431287|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135705|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135706|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135707|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135708|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135709|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135710|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135711|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135712|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135713|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135714|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135715|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135716|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135717|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135718|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135719|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135720|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135721|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
136901|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
135724|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135725|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135726|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135727|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135728|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135729|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135730|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135731|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135732|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135733|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135734|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135735|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135736|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135737|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135738|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135739|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135740|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135741|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135742|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135743|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135744|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135745|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135746|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135747|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135748|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135749|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135750|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135751|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135752|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135753|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135754|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135755|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135756|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135757|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135758|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135759|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135760|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135761|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135762|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135763|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135764|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135765|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135766|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135767|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135768|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135769|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135770|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135771|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135772|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135773|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135774|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135775|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135776|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135777|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135778|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135779|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135780|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135781|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135782|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135783|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135784|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135785|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135786|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135787|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135788|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135789|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135790|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135791|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135792|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135793|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135794|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135795|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135796|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135797|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135798|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135799|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135800|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135801|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135802|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135803|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135804|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135805|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135806|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
136902|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
135807|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135808|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135809|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135810|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135811|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135812|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135813|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135814|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135815|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135816|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135817|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135818|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135819|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135820|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135821|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135822|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135823|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135824|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135825|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135826|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135827|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135828|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135829|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135830|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135831|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135832|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135833|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135834|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135835|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135836|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135837|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135838|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135839|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135840|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135841|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135842|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135843|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135844|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135845|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135846|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135847|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135848|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135849|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135850|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135851|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
135852|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135853|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
135854|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
135855|NCT01431287|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135856|NCT01431287|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135857|NCT01431287|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135858|NCT01431287|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135859|NCT01431287|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135860|NCT01431274|B6|Baseline|Total|Total of all reporting groups
135861|NCT01431274|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135862|NCT01431274|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135863|NCT01431274|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135864|NCT01431274|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135865|NCT01431274|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135866|NCT01431274|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135867|NCT01431274|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135868|NCT01431274|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135869|NCT01431274|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135870|NCT01431274|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135871|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135872|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135873|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135874|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135875|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135876|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135877|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135878|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135879|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135880|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135881|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135882|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135883|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135884|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135885|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135886|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135887|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135888|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135889|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135890|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135891|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135892|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135893|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135894|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135895|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135896|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135897|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135898|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135899|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135900|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135901|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135902|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135903|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135904|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135905|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135906|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135907|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135908|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135909|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135910|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135911|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135912|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135913|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135914|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135915|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135916|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135984|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135917|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135918|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135919|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135920|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135921|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135922|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135923|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135924|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135925|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135926|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135927|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135928|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135929|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135930|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135931|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135932|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135933|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135934|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135935|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135936|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135937|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135938|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135939|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135940|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135941|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135942|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135943|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135944|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135945|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135946|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135947|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135948|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135949|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135950|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135951|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135952|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135953|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135954|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135955|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135956|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135957|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135958|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135959|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135960|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135961|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135962|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135963|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135964|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135965|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135966|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135967|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135968|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135969|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135970|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135971|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135972|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135973|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135974|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135975|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135976|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135977|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135978|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135979|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135980|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135981|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135982|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135983|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136162|NCT01430754|E4|Reported Event|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
135985|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135986|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135987|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135988|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135989|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135990|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135991|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135992|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135993|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135994|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135995|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135996|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135997|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135998|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
135999|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136000|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136001|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136002|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136003|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136004|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136005|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136006|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136007|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136008|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136009|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136010|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136011|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136012|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136013|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136014|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136015|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136016|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136017|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136903|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
136018|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136019|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136020|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136021|NCT01431274|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136022|NCT01431274|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136023|NCT01431274|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136024|NCT01431274|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136025|NCT01431274|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
136026|NCT01431170|B3|Baseline|Total|Total of all reporting groups
136027|NCT01431170|B2|Baseline|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
136028|NCT01431170|B1|Baseline|Besivance Treatment Group|Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
136029|NCT01431170|P2|Participant Flow|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.
136030|NCT01431170|P1|Participant Flow|Besivance Treatment Group|Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
136031|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects treated with Polytrim ophthalmic solution, who achieved treatment success by the study close-out visit (week 16).
136032|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects treated with Besivance™ ophthalmic suspension, 0.6%, who achieved treatment success by the study close-out visit (week 16).
136033|NCT01431170|O2|Outcome|Polytrim Safety Outcomes|Number of reported medication safety issues in the Polytrim Treatment Group
136034|NCT01431170|O1|Outcome|Besivance Safety Outcomes|Number of reported medication safety issues in the Besivance Treatment Group.
136035|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of Treatment Failures for subjects randomized to the Polytrim treatment group.
136036|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of Treatment Failures for subjects randomized to the Besivance treatment group.
136037|NCT01431170|O2|Outcome|Efficacy of Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
136038|NCT01431170|O1|Outcome|Efficacy of Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
136039|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
136040|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
136041|NCT01431170|O2|Outcome|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution in the study eye, one drop three times daily for ten days.
136042|NCT01431170|O1|Outcome|Besivance Treatment Group|Subjects received Besivance ophthalmic solution in the study eye, one drop three times a day for ten days
136043|NCT01431170|E2|Reported Event|Polytrim Treatment Group|Subjects randomized to the Polytrim treatment group.
136044|NCT01431170|E1|Reported Event|Besivance Treatment Group|Subjects randomized to the Besivance treatment group.
136045|NCT01431144|B3|Baseline|Total|Total of all reporting groups
136046|NCT01431144|B2|Baseline|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136047|NCT01431144|B1|Baseline|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136048|NCT01431144|P2|Participant Flow|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136049|NCT01431144|P1|Participant Flow|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136050|NCT01431144|O2|Outcome|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136051|NCT01431144|O1|Outcome|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136052|NCT01431144|E2|Reported Event|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136053|NCT01431144|E1|Reported Event|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
136054|NCT01431131|B3|Baseline|Total|Total of all reporting groups
136055|NCT01431131|B2|Baseline|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
136056|NCT01431131|B1|Baseline|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
136057|NCT01431131|P2|Participant Flow|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
136058|NCT01431131|P1|Participant Flow|Intrasocket Graft|Positive control, an intrasocket cancellous allograft is placed
136059|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
136060|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
136061|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
136062|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
136063|NCT01431131|E2|Reported Event|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
136064|NCT01431131|E1|Reported Event|Intrasocket Graft|Positive control, an intrasocket cancellous allograft will be placed
136065|NCT01431079|B3|Baseline|Total|Total of all reporting groups
136066|NCT01431079|B2|Baseline|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136067|NCT01431079|B1|Baseline|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136068|NCT01431079|P2|Participant Flow|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136069|NCT01431079|P1|Participant Flow|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136070|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
136071|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136072|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
136073|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136074|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136075|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136076|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
136077|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136078|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
136079|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136080|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136081|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136082|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
136083|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136084|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
136085|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136086|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136087|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136088|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for an education based on knowledge regarding HPV vaccine acceptability.
136089|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136090|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for an education based on knowledge regarding HPV vaccine acceptability.
136091|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide posttest data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136092|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136093|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136094|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
136095|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136096|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
136097|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136098|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136099|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide base line data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136100|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This control group will provide follow-up data for knowledge based education for HPV vaccine
136101|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental group will provide follow-up data for an Health belief model based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136102|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This control group will provide post test data for knowledge based education for HPV vaccine
136103|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental group will provide post test data for an HBM based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136104|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136105|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136106|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data regarding education based on knowledge regarding HPV vaccine acceptability.
136107|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136108|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data regarding education based on knowledge regarding HPV vaccine acceptability.
136109|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136110|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data regarding education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136111|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136112|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
136113|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136114|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
136163|NCT01430754|E3|Reported Event|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136115|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
136116|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136117|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for number of people who have taken HPV vaccine before an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136118|NCT01431079|E2|Reported Event|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136119|NCT01431079|E1|Reported Event|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
136120|NCT01431014|B3|Baseline|Total|Total of all reporting groups
136121|NCT01431014|B2|Baseline|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
136122|NCT01431014|B1|Baseline|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
136123|NCT01431014|P2|Participant Flow|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
136124|NCT01431014|P1|Participant Flow|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
136125|NCT01431014|O2|Outcome|"DexamethasoneLow-dose"|"5mg Dexamethasonelow-dose : 5 mg"
136126|NCT01431014|O1|Outcome|"DexamethasoneHigh-dose"|"15mg Dexamethasonehigh-dose : 15 mg"
136127|NCT01431014|E2|Reported Event|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose: 15 mg"
136128|NCT01431014|E1|Reported Event|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose: 5mg"
136129|NCT01430819|B3|Baseline|Total|Total of all reporting groups
136130|NCT01430819|B2|Baseline|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136131|NCT01430819|B1|Baseline|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136132|NCT01430819|P2|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
136133|NCT01430819|P1|Participant Flow|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
136134|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136135|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136136|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136137|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136138|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136139|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136140|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136141|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136142|NCT01430819|E2|Reported Event|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
136143|NCT01430819|E1|Reported Event|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
136144|NCT01430754|B4|Baseline|Total|Total of all reporting groups
136145|NCT01430754|B3|Baseline|Placebo (Randomized)|"Placebo capsules~Placebo: Placebo capsules, daily"
136146|NCT01430754|B2|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136147|NCT01430754|B1|Baseline|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
136148|NCT01430754|P2|Participant Flow|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136149|NCT01430754|P1|Participant Flow|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136150|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136151|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136152|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136153|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136154|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136155|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136156|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136157|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136158|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136159|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136160|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
136161|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136164|NCT01430754|E2|Reported Event|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
136165|NCT01430754|E1|Reported Event|Total Run-In|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
136166|NCT01430624|B4|Baseline|Total|Total of all reporting groups
136167|NCT01430624|B3|Baseline|Standard Care (Completing Baseline)|Standard Care Condition completing baseline
136168|NCT01430624|B2|Baseline|PIRI (Completing Baseline)|Pleasant Imagery and Relaxation Instruction
136169|NCT01430624|B1|Baseline|PPRS (Completing Baseline)|Prevention of Post-Sexual Assault Stress
136170|NCT01430624|P3|Participant Flow|Standard Care|Treatment as usual
136171|NCT01430624|P2|Participant Flow|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136172|NCT01430624|P1|Participant Flow|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136173|NCT01430624|O3|Outcome|Standard Care|Treatment as usual which included standard care
136174|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136175|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136176|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136177|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136178|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136179|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136180|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136181|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136182|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136183|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136184|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136185|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136186|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136187|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136188|NCT01430624|O3|Outcome|SC Condition|Standard Care Completing Follow-up
136189|NCT01430624|O2|Outcome|PIRI|Pleasant Imagery and Relaxation Condition
136190|NCT01430624|O1|Outcome|PPRS|Prevention of Post-Sexual Assault Stress
136191|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136192|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136193|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136194|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
136195|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
136196|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
136197|NCT01430624|E3|Reported Event|Standard Care Condition|Standard Care Condition
136198|NCT01430624|E2|Reported Event|PIRI|Pleasant Imagery and Relaxation Instruction
136199|NCT01430624|E1|Reported Event|PPRS|Prevention of Post-Sexual Assault Stress
136200|NCT01430611|B3|Baseline|Total|Total of all reporting groups
136201|NCT01430611|B2|Baseline|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136202|NCT01430611|B1|Baseline|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136203|NCT01430611|P2|Participant Flow|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136204|NCT01430611|P1|Participant Flow|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136205|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136206|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136207|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136208|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136209|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136210|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136211|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136212|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136213|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136214|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136215|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136216|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136217|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136218|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136219|NCT01430611|E2|Reported Event|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
136220|NCT01430611|E1|Reported Event|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
136221|NCT01430585|B1|Baseline|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136222|NCT01430585|P1|Participant Flow|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136223|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136224|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136225|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136226|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136227|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136228|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136229|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136230|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136231|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136232|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136233|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136234|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136235|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136236|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136352|NCT01430130|O1|Outcome|Treated Side|Half of the revised incision was treated with the embrace device.
136237|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136238|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136239|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136240|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136241|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136242|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136243|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136244|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136245|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136246|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136247|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136248|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136249|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136250|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136251|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
136252|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136253|NCT01430585|E1|Reported Event|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
136254|NCT01430403|B4|Baseline|Total|Total of all reporting groups
136255|NCT01430403|B3|Baseline|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
136256|NCT01430403|B2|Baseline|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
136257|NCT01430403|B1|Baseline|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
136258|NCT01430403|P3|Participant Flow|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
136259|NCT01430403|P2|Participant Flow|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
136260|NCT01430403|P1|Participant Flow|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
136261|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136262|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136263|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136264|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136265|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136266|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136267|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136268|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136269|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136270|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136271|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136272|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136273|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136274|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136275|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136276|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136317|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136277|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136278|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136279|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136280|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136281|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136282|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136283|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136284|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136285|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136286|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136287|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136288|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136289|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136290|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136291|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136292|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136351|NCT01430130|O2|Outcome|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
136904|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
136293|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136294|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136295|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136296|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
136297|NCT01430403|E3|Reported Event|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
136298|NCT01430403|E2|Reported Event|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
136299|NCT01430403|E1|Reported Event|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
136300|NCT01430325|B5|Baseline|Total|Total of all reporting groups
136301|NCT01430325|B4|Baseline|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136302|NCT01430325|B3|Baseline|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136303|NCT01430325|B2|Baseline|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136304|NCT01430325|B1|Baseline|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136305|NCT01430325|P4|Participant Flow|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136306|NCT01430325|P3|Participant Flow|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136307|NCT01430325|P2|Participant Flow|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136308|NCT01430325|P1|Participant Flow|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136309|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136310|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136311|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136312|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136313|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136314|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136315|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136316|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136318|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136319|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136320|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136321|NCT01430325|E4|Reported Event|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136322|NCT01430325|E3|Reported Event|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136323|NCT01430325|E2|Reported Event|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
136324|NCT01430325|E1|Reported Event|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
136325|NCT01430182|B3|Baseline|Total|Total of all reporting groups
136326|NCT01430182|B2|Baseline|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136327|NCT01430182|B1|Baseline|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136328|NCT01430182|P2|Participant Flow|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136329|NCT01430182|P1|Participant Flow|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136330|NCT01430182|O2|Outcome|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136331|NCT01430182|O1|Outcome|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136332|NCT01430182|E2|Reported Event|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136333|NCT01430182|E1|Reported Event|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
136334|NCT01430169|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136335|NCT01430169|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)"
136336|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136337|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136338|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136339|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136340|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136341|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136342|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136343|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136344|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136345|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136346|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136347|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136348|NCT01430169|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
136349|NCT01430130|B1|Baseline|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
136350|NCT01430130|P1|Participant Flow|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
136353|NCT01430130|E2|Reported Event|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
136354|NCT01430130|E1|Reported Event|Treated Side|Half of the revised incision was treated with the embrace device.
136355|NCT01430104|B1|Baseline|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136356|NCT01430104|P1|Participant Flow|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136357|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136358|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136359|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136360|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136361|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136362|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136363|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136364|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136365|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136366|NCT01430104|E1|Reported Event|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
136367|NCT01430091|B1|Baseline|Participants|Total Number of Study Participants
136368|NCT01430091|P1|Participant Flow|Participants|Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
136369|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
136370|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
136371|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
136372|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating table (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
136373|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole approximately 180 milliliters (ml) with water.
136374|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
136375|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
136376|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
136377|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
136378|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
136379|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
136380|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
136381|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
136382|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
136383|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
136384|NCT01430091|E5|Reported Event|ODT (Under Tongue)|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
136385|NCT01430091|E4|Reported Event|ODT (Chew and Swallow)|5-mg prasugrel ODT chewed and swallowed, no liquid given.
136386|NCT01430091|E3|Reported Event|ODT (Juice Chaser)|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
136387|NCT01430091|E2|Reported Event|ODT (Top of Tongue)|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
136388|NCT01430091|E1|Reported Event|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
136389|NCT01429584|B3|Baseline|Total|Total of all reporting groups
136390|NCT01429584|B2|Baseline|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136391|NCT01429584|B1|Baseline|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136392|NCT01429584|P2|Participant Flow|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136393|NCT01429584|P1|Participant Flow|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136394|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136395|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136396|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136397|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136398|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136399|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136400|NCT01429584|E2|Reported Event|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
136401|NCT01429584|E1|Reported Event|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
136402|NCT01429532|B4|Baseline|Total|Total of all reporting groups
136403|NCT01429532|B3|Baseline|Group III|3.0-mm-incision-size phacoemulsification system
136404|NCT01429532|B2|Baseline|Group II|2.2-mm-incision-size phacoemulsification system
136405|NCT01429532|B1|Baseline|Group I|1.8-mm-incision-size phacoemulsification system
136406|NCT01429532|P3|Participant Flow|Group III|3.0-mm-incision-size phacoemulsification system
136407|NCT01429532|P2|Participant Flow|Group II|2.2-mm-incision-size phacoemulsification system
136408|NCT01429532|P1|Participant Flow|Group I|1.8-mm-incision-size phacoemulsification system
136409|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
136410|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
136411|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
136412|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
136413|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
136414|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
136415|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
136416|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
136417|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
136418|NCT01429532|E3|Reported Event|Group III|3.0-mm-incision-size phacoemulsification system
136419|NCT01429532|E2|Reported Event|Group II|2.2-mm-incision-size phacoemulsification system
136420|NCT01429532|E1|Reported Event|Group I|1.8-mm-incision-size phacoemulsification system
136421|NCT01429441|B3|Baseline|Total|Total of all reporting groups
136422|NCT01429441|B2|Baseline|Sham|Subjects in the sham group received a single sham injection
136423|NCT01429441|B1|Baseline|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
136424|NCT01429441|P2|Participant Flow|Sham|Subjects in the sham group received a single sham injection
136425|NCT01429441|P1|Participant Flow|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
136426|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
136427|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
136428|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
136429|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
136430|NCT01429441|E2|Reported Event|Sham|Subjects in the sham group received a single sham injection
136431|NCT01429441|E1|Reported Event|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
136432|NCT01429259|B1|Baseline|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
136433|NCT01429259|P1|Participant Flow|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
136434|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
136435|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
136472|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136436|NCT01429259|E1|Reported Event|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
136437|NCT01429077|B3|Baseline|Total|Total of all reporting groups
136438|NCT01429077|B2|Baseline|Inactive Pill|
136439|NCT01429077|B1|Baseline|Levodopa|
136440|NCT01429077|P2|Participant Flow|Inactive Pill|The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
136441|NCT01429077|P1|Participant Flow|Levodopa|The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
136442|NCT01429077|O2|Outcome|Inactive Pill|
136443|NCT01429077|O1|Outcome|Levodopa/Carbidopa|
136444|NCT01429077|E2|Reported Event|Inactive Pill|
136445|NCT01429077|E1|Reported Event|Levodopa|
136446|NCT01429064|B5|Baseline|Total|Total of all reporting groups
136447|NCT01429064|B4|Baseline|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136448|NCT01429064|B3|Baseline|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136449|NCT01429064|B2|Baseline|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136450|NCT01429064|B1|Baseline|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
136451|NCT01429064|P4|Participant Flow|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136452|NCT01429064|P3|Participant Flow|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136453|NCT01429064|P2|Participant Flow|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136454|NCT01429064|P1|Participant Flow|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
136455|NCT01429064|O4|Outcome|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136456|NCT01429064|O3|Outcome|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136457|NCT01429064|O2|Outcome|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136458|NCT01429064|O1|Outcome|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
136459|NCT01429064|E4|Reported Event|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136460|NCT01429064|E3|Reported Event|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136461|NCT01429064|E2|Reported Event|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
136462|NCT01429064|E1|Reported Event|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
136463|NCT01429051|B1|Baseline|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
136464|NCT01429051|P1|Participant Flow|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
136465|NCT01429051|O3|Outcome|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
136466|NCT01429051|O2|Outcome|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
136467|NCT01429051|O1|Outcome|Titration Phase|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase.
136468|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136469|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136470|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136471|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136503|NCT01428765|O1|Outcome|All Patients|
136504|NCT01428765|O1|Outcome|All Patients|
136473|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136474|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136475|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136476|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136477|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136478|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
136479|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
136480|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
136481|NCT01429051|E3|Reported Event|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
136482|NCT01429051|E2|Reported Event|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
136483|NCT01429051|E1|Reported Event|Titration Phase|Participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I).
136484|NCT01428882|B3|Baseline|Total|Total of all reporting groups
136485|NCT01428882|B2|Baseline|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136486|NCT01428882|B1|Baseline|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136487|NCT01428882|P2|Participant Flow|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136488|NCT01428882|P1|Participant Flow|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136489|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136490|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136491|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136492|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136493|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136494|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136495|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136496|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136497|NCT01428882|E2|Reported Event|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136498|NCT01428882|E1|Reported Event|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
136499|NCT01428765|B1|Baseline|All Patients|
136500|NCT01428765|P1|Participant Flow|All Patients|
136501|NCT01428765|O1|Outcome|All Patients|
136502|NCT01428765|O1|Outcome|All Patients|
136510|NCT01428713|B1|Baseline|All Study Participants|"Group A: TA first, then COCP:~Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP.~Group B: COCP first, then TA:~Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.~Subsequently, patients who initially received COCP, received TA."
136511|NCT01428713|P2|Participant Flow|Group B: COCP First, Then TA|"Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA.~Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles."
136512|NCT01428713|P1|Participant Flow|Group A: TA First, Then COCP|"Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP."
136513|NCT01428713|O2|Outcome|Group: COCP|Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
136514|NCT01428713|O1|Outcome|Group: TA|Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
136515|NCT01428713|E2|Reported Event|Combined Oral Contraceptives (COCP)|COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
136516|NCT01428713|E1|Reported Event|Tranexamic Acid (TA)|"Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA."
136517|NCT01428661|B4|Baseline|Total|Total of all reporting groups
136518|NCT01428661|B3|Baseline|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
136519|NCT01428661|B2|Baseline|Placebo|Placebo capsules, PO daily for 8 weeks
136520|NCT01428661|B1|Baseline|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
136521|NCT01428661|P3|Participant Flow|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
136522|NCT01428661|P2|Participant Flow|Placebo|Placebo capsules, PO daily for 8 weeks
136523|NCT01428661|P1|Participant Flow|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
136524|NCT01428661|O3|Outcome|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
136525|NCT01428661|O2|Outcome|Placebo|Placebo capsules, PO daily for 8 weeks
136526|NCT01428661|O1|Outcome|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
136527|NCT01428661|E3|Reported Event|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
136528|NCT01428661|E2|Reported Event|Placebo|Placebo capsules, PO daily for 8 weeks
136529|NCT01428661|E1|Reported Event|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
136530|NCT01428583|B1|Baseline|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136531|NCT01428583|P1|Participant Flow|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136532|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136560|NCT01428115|B1|Baseline|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136561|NCT01428115|P1|Participant Flow|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136533|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136534|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136535|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136536|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136537|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136538|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136539|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136540|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136541|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136542|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136543|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136544|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136562|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136563|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136905|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
136545|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136546|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136547|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136548|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136549|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136550|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136551|NCT01428583|E1|Reported Event|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
136552|NCT01428219|B1|Baseline|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
136553|NCT01428219|P1|Participant Flow|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
136554|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
136555|NCT01428219|E1|Reported Event|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
136556|NCT01428128|B1|Baseline|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
136557|NCT01428128|P1|Participant Flow|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
136558|NCT01428128|O1|Outcome|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
136559|NCT01428128|E1|Reported Event|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
136906|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
136564|NCT01428115|O1|Outcome|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136565|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136566|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136567|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136568|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136569|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136570|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136571|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136572|NCT01428115|E1|Reported Event|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
136573|NCT01428076|B3|Baseline|Total|Total of all reporting groups
136574|NCT01428076|B2|Baseline|Polidocanol 2%|polidocanol intravenous foam 2% concentration
136575|NCT01428076|B1|Baseline|Polidocanol 1%|polidocanol injectable foam 1% concentration
136576|NCT01428076|P2|Participant Flow|Polidocanol 2%|polidocanol injectable foam 2% concentration
136577|NCT01428076|P1|Participant Flow|Polidocanol 1%|polidocanol injectable foam 1% concentration
136578|NCT01428076|O4|Outcome|Females- Polidocanol 2%|polidocanol injectable foam 2% concentration
136579|NCT01428076|O3|Outcome|Females-polidocanol 1%|polidocanol injectable foam 1% concentration
136580|NCT01428076|O2|Outcome|Males-polidocanol 2%|polidocanol injectable foam 2% concentration
136581|NCT01428076|O1|Outcome|Males-polidocanol 1%|polidocanol injectable foam 1% concentration
136582|NCT01428076|E2|Reported Event|Polidocanol 2%|polidocanol injectable foam 2% concentration
136583|NCT01428076|E1|Reported Event|Polidocanol 1%|polidocanol injectable foam 1% concentration
136584|NCT01428063|B4|Baseline|Total|Total of all reporting groups
136585|NCT01428063|B3|Baseline|Daclatasvir + pegIFN-2a+ Ribavirin|Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
136586|NCT01428063|B2|Baseline|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
136587|NCT01428063|B1|Baseline|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
136588|NCT01428063|P3|Participant Flow|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136589|NCT01428063|P2|Participant Flow|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
136590|NCT01428063|P1|Participant Flow|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
136591|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136592|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136593|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136594|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136595|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136596|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136597|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136598|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136599|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136600|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136601|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136602|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136603|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136604|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136605|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136606|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136607|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136608|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136609|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136610|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136611|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136612|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136613|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136614|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136615|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136616|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136617|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136659|NCT01427933|B2|Baseline|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
153858|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
136618|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136619|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136620|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136621|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136622|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136623|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136624|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136625|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136626|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136627|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136628|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136629|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136630|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136631|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136632|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136633|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136634|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136635|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136636|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136637|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136806|NCT01427504|E1|Reported Event|Boceprevir Alone|Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.
136638|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136639|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136640|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136641|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136642|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136643|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136644|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136645|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136646|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
136647|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
136648|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136649|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136650|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136651|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136652|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)|Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136653|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
136654|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
136655|NCT01428063|E3|Reported Event|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
136656|NCT01428063|E2|Reported Event|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
136657|NCT01428063|E1|Reported Event|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.
136658|NCT01427933|B3|Baseline|Total|Total of all reporting groups
136807|NCT01427309|B5|Baseline|Total|Total of all reporting groups
136660|NCT01427933|B1|Baseline|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136661|NCT01427933|P2|Participant Flow|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136662|NCT01427933|P1|Participant Flow|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136663|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136664|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136665|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136666|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136667|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136668|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136669|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136670|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136671|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136672|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136673|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136674|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136675|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136676|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136677|NCT01427933|E2|Reported Event|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
136678|NCT01427933|E1|Reported Event|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
136679|NCT01427920|B3|Baseline|Total|Total of all reporting groups
136680|NCT01427920|B2|Baseline|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136681|NCT01427920|B1|Baseline|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136682|NCT01427920|P2|Participant Flow|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136683|NCT01427920|P1|Participant Flow|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136808|NCT01427309|B4|Baseline|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
153859|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
136684|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136685|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136686|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136687|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136688|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136689|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136690|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136691|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136692|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136711|NCT01427803|B1|Baseline|Patterns of Use User Population|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
153860|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
136693|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136694|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136695|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136696|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136697|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136698|NCT01427920|E2|Reported Event|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136699|NCT01427920|E1|Reported Event|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
136700|NCT01427907|B3|Baseline|Total|Total of all reporting groups
136701|NCT01427907|B2|Baseline|Sequence II: Sevelamer Then COS|Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
136702|NCT01427907|B1|Baseline|Sequence I: COS Then Sevelamer|Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
136703|NCT01427907|P2|Participant Flow|Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)|Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
136704|NCT01427907|P1|Participant Flow|Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)|Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
136705|NCT01427907|O2|Outcome|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
136706|NCT01427907|O1|Outcome|Calcium Acetate Oral Solution|Calcium Acetate Oral Solution for periods 1 and 2
136707|NCT01427907|E2|Reported Event|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
136708|NCT01427907|E1|Reported Event|Calcium Acetate Oral Solution|Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
136709|NCT01427803|B3|Baseline|Total|Total of all reporting groups
136710|NCT01427803|B2|Baseline|Reasons for Misuse Interviewed Population|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
153861|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
136712|NCT01427803|P2|Participant Flow|Reasons for Misuse Cohort|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
136713|NCT01427803|P1|Participant Flow|Patterns of Use Cohort|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
136714|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136715|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136716|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136717|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136718|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136719|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136720|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136721|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136722|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136723|NCT01427803|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
136724|NCT01427751|B3|Baseline|Total|Total of all reporting groups
136725|NCT01427751|B2|Baseline|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136726|NCT01427751|B1|Baseline|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136727|NCT01427751|P2|Participant Flow|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136728|NCT01427751|P1|Participant Flow|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136729|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136730|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136731|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136732|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136733|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136734|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136735|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136736|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
137804|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
136737|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136738|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136739|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136740|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136741|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136742|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136743|NCT01427751|E2|Reported Event|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
136744|NCT01427751|E1|Reported Event|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
136745|NCT01427738|B3|Baseline|Total|Total of all reporting groups
136746|NCT01427738|B2|Baseline|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136747|NCT01427738|B1|Baseline|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136748|NCT01427738|P2|Participant Flow|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136749|NCT01427738|P1|Participant Flow|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136750|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136751|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136752|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136753|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136754|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136755|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136756|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136757|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136758|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136759|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136760|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136761|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136762|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136763|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
153862|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
136764|NCT01427738|E2|Reported Event|Nystatin|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
136765|NCT01427738|E1|Reported Event|Gentian Violet|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
136766|NCT01427517|B4|Baseline|Total|Total of all reporting groups
136767|NCT01427517|B3|Baseline|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
136768|NCT01427517|B2|Baseline|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
136769|NCT01427517|B1|Baseline|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
136770|NCT01427517|P3|Participant Flow|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
136771|NCT01427517|P2|Participant Flow|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
136772|NCT01427517|P1|Participant Flow|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
136773|NCT01427517|O3|Outcome|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
136774|NCT01427517|O2|Outcome|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
136775|NCT01427517|O1|Outcome|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
136776|NCT01427517|E3|Reported Event|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
136777|NCT01427517|E2|Reported Event|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
136778|NCT01427517|E1|Reported Event|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
136779|NCT01427504|B7|Baseline|Total|Total of all reporting groups
136780|NCT01427504|B6|Baseline|Sequence 3b|Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
136781|NCT01427504|B5|Baseline|Sequence 3a|Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
136782|NCT01427504|B4|Baseline|Sequence 2b|Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
136783|NCT01427504|B3|Baseline|Sequence 2a|Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
136784|NCT01427504|B2|Baseline|Sequence 1b|Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
136785|NCT01427504|B1|Baseline|Sequence 1a|Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
136786|NCT01427504|P6|Participant Flow|Sequence 3b|Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136787|NCT01427504|P5|Participant Flow|Sequence 3a|Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136788|NCT01427504|P4|Participant Flow|Sequence 2b|Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136789|NCT01427504|P3|Participant Flow|Sequence 2a|Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136790|NCT01427504|P2|Participant Flow|Sequence 1b|Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136791|NCT01427504|P1|Participant Flow|Sequence 1a|Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
136792|NCT01427504|O1|Outcome|Etravirine Cmin Coadministered With Boceprevir|Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
136793|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
136794|NCT01427504|O1|Outcome|Etravirine AUC Coadministered With Boceprevir|Geometric mean ratio of etravirine AUC when coadministered with boceprevir
136795|NCT01427504|O1|Outcome|Boceprevir C8 Coadministered With Etravirine|Geometric mean ratio of boceprevir C8 when coadministered with etravirine
136796|NCT01427504|O1|Outcome|Boceprevir Cmax Coadministered With Etravirine|Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
136797|NCT01427504|O1|Outcome|Boceprevir AUC Coadministered With Etravirine|Geometric mean ratio of boceprevir AUC when coadministered with etravirine
136798|NCT01427504|O1|Outcome|Etravirine Cmin|Geometric mean of etravirine Cmin when administered alone.
136799|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean of etravirine Cmax when administered alone.
136800|NCT01427504|O1|Outcome|Etravirine AUC|Geometric mean of etravirine AUC when administered alone.
136801|NCT01427504|O1|Outcome|Boceprevir C8|Geometric mean of boceprevir Cmax when administered alone.
136802|NCT01427504|O1|Outcome|Boceprevir Cmax|Geometric mean of boceprevir Cmax when administered alone.
136803|NCT01427504|O1|Outcome|Boceprevir AUC|Geometric mean of boceprevir AUC administered alone.
136804|NCT01427504|E3|Reported Event|Boceprevir Coadministered With Etravirine|Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
136805|NCT01427504|E2|Reported Event|Etravirine Alone|Subjects took etravirine alone, 200 mg twice daily, for 10-14 days
136809|NCT01427309|B3|Baseline|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136810|NCT01427309|B2|Baseline|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136811|NCT01427309|B1|Baseline|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136812|NCT01427309|P4|Participant Flow|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136813|NCT01427309|P3|Participant Flow|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136814|NCT01427309|P2|Participant Flow|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136815|NCT01427309|P1|Participant Flow|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136816|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136817|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136818|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136819|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136820|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136821|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136822|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136823|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136824|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136825|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136826|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136827|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136828|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136829|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136830|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136831|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136832|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136833|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136834|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136835|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136836|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136837|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136838|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136839|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136840|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136841|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136842|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136843|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136844|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136845|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136846|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136847|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136848|NCT01427309|E4|Reported Event|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
136849|NCT01427309|E3|Reported Event|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136850|NCT01427309|E2|Reported Event|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
136851|NCT01427309|E1|Reported Event|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
136852|NCT01426958|B1|Baseline|Overall Study|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
136853|NCT01426958|P1|Participant Flow|All Participants|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
136854|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
136855|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
136856|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
136896|NCT01426789|P3|Participant Flow|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
136857|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
136858|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
136859|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
136860|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
136861|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
136862|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
136863|NCT01426958|E3|Reported Event|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
136864|NCT01426958|E2|Reported Event|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
136865|NCT01426958|E1|Reported Event|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
136866|NCT01426867|B4|Baseline|Total|Total of all reporting groups
136867|NCT01426867|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
136868|NCT01426867|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
136869|NCT01426867|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
136870|NCT01426867|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
136871|NCT01426867|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
136872|NCT01426867|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
136873|NCT01426867|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
136874|NCT01426867|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
136875|NCT01426867|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
136876|NCT01426867|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
136877|NCT01426867|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
136878|NCT01426867|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
136879|NCT01426854|B3|Baseline|Total|Total of all reporting groups
136880|NCT01426854|B2|Baseline|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136881|NCT01426854|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136882|NCT01426854|P2|Participant Flow|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136883|NCT01426854|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136884|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136885|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136886|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136887|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136888|NCT01426854|E2|Reported Event|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136889|NCT01426854|E1|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
136890|NCT01426789|B3|Baseline|Total|Total of all reporting groups
136891|NCT01426789|B2|Baseline|Placebo|Placebo i.v.
136892|NCT01426789|B1|Baseline|Secukinumab|10 mg/kg intravenous (I.V.)
136893|NCT01426789|P6|Participant Flow|Group 4|Part 1: placebo; Part 2: no study treatment
136894|NCT01426789|P5|Participant Flow|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
136895|NCT01426789|P4|Participant Flow|Group 2|Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
136907|NCT01426789|E4|Reported Event|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
136908|NCT01426789|E3|Reported Event|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
136909|NCT01426789|E2|Reported Event|Placebo|Placebo i.v.
136910|NCT01426789|E1|Reported Event|Secukinumab|10mg/kg i.v.
136911|NCT01426763|B3|Baseline|Total|Total of all reporting groups
136912|NCT01426763|B2|Baseline|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
136913|NCT01426763|B1|Baseline|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
136914|NCT01426763|P2|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
136915|NCT01426763|P1|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks
136916|NCT01426763|O2|Outcome|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
136917|NCT01426763|O1|Outcome|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
136918|NCT01426763|E2|Reported Event|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
136919|NCT01426763|E1|Reported Event|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
136920|NCT01426555|B3|Baseline|Total|Total of all reporting groups
136921|NCT01426555|B2|Baseline|Rowing Arm|Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
136922|NCT01426555|B1|Baseline|ZA Infusion Arm|Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
136923|NCT01426555|P2|Participant Flow|ZA Infusion Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
136924|NCT01426555|P1|Participant Flow|Rowing Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
136925|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
136926|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, were enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
136927|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
136928|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
136929|NCT01426555|E2|Reported Event|Rowing Arm|No adverse event data were available for the remaining 16 participants.
136930|NCT01426555|E1|Reported Event|ZA Infusion Arm|No adverse event data were available for the remaining 9 participants.
136931|NCT01426516|B3|Baseline|Total|Total of all reporting groups
136932|NCT01426516|B2|Baseline|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
136933|NCT01426516|B1|Baseline|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
136934|NCT01426516|P2|Participant Flow|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
136935|NCT01426516|P1|Participant Flow|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
136936|NCT01426516|O2|Outcome|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
136937|NCT01426516|O1|Outcome|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
136938|NCT01426516|E2|Reported Event|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
136967|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136939|NCT01426516|E1|Reported Event|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
136940|NCT01426438|B3|Baseline|Total|Total of all reporting groups
136941|NCT01426438|B2|Baseline|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136942|NCT01426438|B1|Baseline|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136943|NCT01426438|P2|Participant Flow|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136944|NCT01426438|P1|Participant Flow|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136945|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136946|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136947|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136948|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136949|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136950|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136951|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136952|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136953|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136954|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136955|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136956|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136957|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136958|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136959|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136960|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136961|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136962|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136963|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136964|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136965|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136966|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
153863|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
136968|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136969|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136970|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136971|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136972|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
136973|NCT01426438|E2|Reported Event|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
136974|NCT01426438|E1|Reported Event|Arm A: Extended-release Niacin With Aspirin|Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
136975|NCT01426373|B1|Baseline|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136976|NCT01426373|P1|Participant Flow|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136977|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136978|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136979|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136980|NCT01426373|O2|Outcome|Month 12 After Last Treatment|
136981|NCT01426373|O1|Outcome|Month 3 After Last Treatment|
136982|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136983|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136984|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136985|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136986|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136987|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136988|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136989|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136990|NCT01426373|E1|Reported Event|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
136991|NCT01426360|B3|Baseline|Total|Total of all reporting groups
136992|NCT01426360|B2|Baseline|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
136993|NCT01426360|B1|Baseline|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
136994|NCT01426360|P2|Participant Flow|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
136995|NCT01426360|P1|Participant Flow|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
136996|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
136997|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
136998|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
136999|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
137000|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
137001|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
137002|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
137003|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
137004|NCT01426360|E2|Reported Event|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
137005|NCT01426360|E1|Reported Event|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
137006|NCT01426269|B1|Baseline|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
137007|NCT01426269|P3|Participant Flow|Placebo|"Subjects will receive placebo during phase 2 (week 12 – week 52)~Placebo: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning"
137008|NCT01426269|P2|Participant Flow|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)~Oral Doxycycline: During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137009|NCT01426269|P1|Participant Flow|Doxycycline and Metronidazole Regimen|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)~Oral Doxycycline and Topical Metronidazole: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area.~After Period 1, subjects who meet criteria for phase 2 will be randomized to receive doxycycline or placebo during phase 2"
137010|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137011|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137012|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137013|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137014|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137015|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137016|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137017|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137018|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137019|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137020|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137021|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
137022|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
137023|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137504|NCT01424072|B3|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137024|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
137025|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137026|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
137027|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137028|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
137029|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137030|NCT01426269|E3|Reported Event|Period 2: Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: period 2, placebo, oral, one capsule daily in the morning"
137031|NCT01426269|E2|Reported Event|Period 2: Oral Doxycycline|"Subjects will receive oral doxycycline during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
137032|NCT01426269|E1|Reported Event|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
137033|NCT01426230|B3|Baseline|Total|Total of all reporting groups
137034|NCT01426230|B2|Baseline|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
137035|NCT01426230|B1|Baseline|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
137036|NCT01426230|P2|Participant Flow|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
137037|NCT01426230|P1|Participant Flow|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
137038|NCT01426230|O2|Outcome|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
137039|NCT01426230|O1|Outcome|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
137040|NCT01426230|E1|Reported Event|Open Label - Both Cohorts|
137041|NCT01426113|B3|Baseline|Total|Total of all reporting groups
137042|NCT01426113|B2|Baseline|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
137043|NCT01426113|B1|Baseline|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
137044|NCT01426113|P2|Participant Flow|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
137045|NCT01426113|P1|Participant Flow|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
137046|NCT01426113|O2|Outcome|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
137047|NCT01426113|O1|Outcome|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
137048|NCT01426113|E2|Reported Event|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
137049|NCT01426113|E1|Reported Event|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
137050|NCT01425879|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137051|NCT01425879|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137805|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137052|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137053|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137054|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137055|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137056|NCT01425879|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
137057|NCT01425853|B3|Baseline|Total|Total of all reporting groups
137058|NCT01425853|B2|Baseline|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137059|NCT01425853|B1|Baseline|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137060|NCT01425853|P2|Participant Flow|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137061|NCT01425853|P1|Participant Flow|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137062|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137063|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137064|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137065|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137066|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137067|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137068|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137069|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137070|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137071|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137072|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137073|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137074|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137075|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137076|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137077|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137078|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137079|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137080|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137081|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137082|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137083|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137084|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137085|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137086|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137087|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137088|NCT01425853|E2|Reported Event|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
137089|NCT01425853|E1|Reported Event|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
137090|NCT01425749|B3|Baseline|Total|Total of all reporting groups
137091|NCT01425749|B2|Baseline|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137092|NCT01425749|B1|Baseline|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137093|NCT01425749|P2|Participant Flow|Arm B: Intradermal/Subcutaneous Injections|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137094|NCT01425749|P1|Participant Flow|Arm A: Intramuscular Injections|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137095|NCT01425749|O1|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137096|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137097|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137098|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137099|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137100|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137101|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137102|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137103|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137104|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137105|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137106|NCT01425749|E2|Reported Event|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137107|NCT01425749|E1|Reported Event|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
137108|NCT01425632|B4|Baseline|Total|Total of all reporting groups
137109|NCT01425632|B3|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
137110|NCT01425632|B2|Baseline|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
137111|NCT01425632|B1|Baseline|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
137112|NCT01425632|P3|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
137113|NCT01425632|P2|Participant Flow|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
137114|NCT01425632|P1|Participant Flow|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
137115|NCT01425632|O3|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
137116|NCT01425632|O2|Outcome|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
137117|NCT01425632|O1|Outcome|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
137118|NCT01425632|E3|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
137119|NCT01425632|E2|Reported Event|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
137120|NCT01425632|E1|Reported Event|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
137121|NCT01425528|B3|Baseline|Total|Total of all reporting groups
137122|NCT01425528|B2|Baseline|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137123|NCT01425528|B1|Baseline|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137124|NCT01425528|P2|Participant Flow|Cohort 2|Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
137125|NCT01425528|P1|Participant Flow|Cohort 1|This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
137126|NCT01425528|O2|Outcome|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137127|NCT01425528|O1|Outcome|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137128|NCT01425528|E2|Reported Event|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137129|NCT01425528|E1|Reported Event|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
137130|NCT01425463|B3|Baseline|Total|Total of all reporting groups
137131|NCT01425463|B2|Baseline|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137132|NCT01425463|B1|Baseline|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137133|NCT01425463|P2|Participant Flow|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137134|NCT01425463|P1|Participant Flow|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137135|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137136|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137137|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137138|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137139|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137140|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137141|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137142|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137143|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137144|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137145|NCT01425463|E2|Reported Event|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
137146|NCT01425463|E1|Reported Event|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
137147|NCT01425359|B3|Baseline|Total|Total of all reporting groups
137148|NCT01425359|B2|Baseline|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137149|NCT01425359|B1|Baseline|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137189|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
137150|NCT01425359|P2|Participant Flow|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137151|NCT01425359|P1|Participant Flow|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137152|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137153|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137154|NCT01425359|O2|Outcome|Qualifying Phase: Participants Entered a 2-week Washout Period|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137155|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137156|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137157|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137158|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137159|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137160|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137190|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137191|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
137691|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137161|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137162|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137163|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137164|NCT01425359|E2|Reported Event|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
137165|NCT01425359|E1|Reported Event|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
137166|NCT01425229|B1|Baseline|Bosentan|Bosentan PK
137167|NCT01425229|P1|Participant Flow|Bosentan|Bosentan pharmacokinetics
137168|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
137169|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
137170|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
137171|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
137172|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
137173|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
137174|NCT01425229|E3|Reported Event|Bosentan During Clarithromycin|Bosentan PK during clarithromycin
137175|NCT01425229|E2|Reported Event|Bosentan at Steady-state|Bosentan PK at steady-state
137176|NCT01425229|E1|Reported Event|Bosentan After First Dose|Bosentan PK after first dose
137177|NCT01425203|B3|Baseline|Total|Total of all reporting groups
137178|NCT01425203|B2|Baseline|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137179|NCT01425203|B1|Baseline|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
137180|NCT01425203|P3|Participant Flow|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
137181|NCT01425203|P2|Participant Flow|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137182|NCT01425203|P1|Participant Flow|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
137183|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
137184|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137185|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
137186|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
137187|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137188|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
153864|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
137192|NCT01425203|E3|Reported Event|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
137193|NCT01425203|E2|Reported Event|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
137194|NCT01425203|E1|Reported Event|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
137195|NCT01425190|B4|Baseline|Total|Total of all reporting groups
137196|NCT01425190|B3|Baseline|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137197|NCT01425190|B2|Baseline|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137198|NCT01425190|B1|Baseline|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137199|NCT01425190|P3|Participant Flow|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137200|NCT01425190|P2|Participant Flow|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137201|NCT01425190|P1|Participant Flow|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137202|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137203|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137204|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137205|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137206|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137207|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137208|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137209|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137262|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137210|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137211|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137212|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137213|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137214|NCT01425190|E3|Reported Event|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137215|NCT01425190|E2|Reported Event|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137216|NCT01425190|E1|Reported Event|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
137217|NCT01424943|B3|Baseline|Total|Total of all reporting groups
137218|NCT01424943|B2|Baseline|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137219|NCT01424943|B1|Baseline|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137220|NCT01424943|P2|Participant Flow|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137221|NCT01424943|P1|Participant Flow|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137222|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137223|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137224|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137225|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137226|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137227|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137228|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137229|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137230|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137231|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137232|NCT01424943|E2|Reported Event|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
137233|NCT01424943|E1|Reported Event|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
137234|NCT01424930|B3|Baseline|Total|Total of all reporting groups
137263|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
153928|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
137235|NCT01424930|B2|Baseline|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137236|NCT01424930|B1|Baseline|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137237|NCT01424930|P2|Participant Flow|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137238|NCT01424930|P1|Participant Flow|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137239|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137240|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137241|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137242|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137243|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137244|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137245|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137246|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137247|NCT01424930|E2|Reported Event|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
137248|NCT01424930|E1|Reported Event|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
137249|NCT01424813|B3|Baseline|Total|Total of all reporting groups
137250|NCT01424813|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137251|NCT01424813|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137252|NCT01424813|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137253|NCT01424813|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137254|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137255|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137256|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137257|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137258|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137259|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137260|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137261|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137264|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137265|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137266|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137267|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137268|NCT01424813|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
137269|NCT01424813|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
137270|NCT01424644|B3|Baseline|Total|Total of all reporting groups
137271|NCT01424644|B2|Baseline|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137272|NCT01424644|B1|Baseline|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137273|NCT01424644|P2|Participant Flow|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137274|NCT01424644|P1|Participant Flow|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137275|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137276|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137277|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137278|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137279|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137280|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137281|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137282|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137283|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137284|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137285|NCT01424644|E2|Reported Event|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137286|NCT01424644|E1|Reported Event|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
137287|NCT01424501|B7|Baseline|Total|Total of all reporting groups
137288|NCT01424501|B6|Baseline|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137289|NCT01424501|B5|Baseline|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137290|NCT01424501|B4|Baseline|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137291|NCT01424501|B3|Baseline|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137292|NCT01424501|B2|Baseline|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137293|NCT01424501|B1|Baseline|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137294|NCT01424501|P6|Participant Flow|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137295|NCT01424501|P5|Participant Flow|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137296|NCT01424501|P4|Participant Flow|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137297|NCT01424501|P3|Participant Flow|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137298|NCT01424501|P2|Participant Flow|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137299|NCT01424501|P1|Participant Flow|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137300|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137301|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137302|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137303|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137304|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137305|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137306|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137307|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137308|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137309|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137310|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137311|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137312|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137313|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137314|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137315|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137316|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137317|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137318|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137319|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137320|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137321|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137322|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137323|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137324|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137325|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137326|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137499|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137327|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137328|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137329|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137330|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137331|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137332|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137333|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137334|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137335|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137336|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137337|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137338|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137339|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137340|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137341|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137342|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137343|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137344|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137345|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137346|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137347|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137348|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137349|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137350|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137351|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137352|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137353|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137354|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137355|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137356|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137500|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137357|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137358|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137359|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137360|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137361|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137362|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137363|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137364|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137365|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137366|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137367|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137368|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137369|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137370|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137371|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137372|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137373|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137374|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137375|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137376|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137377|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137378|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137379|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137380|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137381|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137382|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137383|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137384|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137385|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137386|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137501|NCT01424228|E2|Reported Event|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137387|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137388|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137389|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137390|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137391|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137392|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137393|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137394|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137395|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137396|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137397|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137398|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137399|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137400|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137401|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137402|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137403|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137404|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137405|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137406|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137407|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137408|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137409|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137410|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137411|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137412|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137413|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137414|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137415|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137416|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137502|NCT01424228|E1|Reported Event|Placebo|Tablet once daily before breakfast
137417|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137418|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137419|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137420|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137421|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137422|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137423|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137424|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137425|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137426|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137427|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137428|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137429|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137430|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137431|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137432|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137433|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137434|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137435|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137436|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137437|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137438|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137439|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137440|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137441|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137442|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137443|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
137444|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137445|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137446|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137503|NCT01424072|B4|Baseline|Total|Total of all reporting groups
137447|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137448|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137449|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137450|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137451|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137452|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137453|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137454|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137455|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137456|NCT01424501|E6|Reported Event|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137457|NCT01424501|E5|Reported Event|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137458|NCT01424501|E4|Reported Event|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137459|NCT01424501|E3|Reported Event|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137460|NCT01424501|E2|Reported Event|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
137461|NCT01424501|E1|Reported Event|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
137462|NCT01424228|B3|Baseline|Total|Total of all reporting groups
137463|NCT01424228|B2|Baseline|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137464|NCT01424228|B1|Baseline|Placebo|Tablet once daily before breakfast
137465|NCT01424228|P2|Participant Flow|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137466|NCT01424228|P1|Participant Flow|Placebo|Tablet once daily before breakfast
137467|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137468|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137469|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137470|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137471|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137472|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137473|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137474|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137475|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137476|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137477|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137478|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137479|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137480|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137481|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137482|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137483|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137484|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137485|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137486|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137487|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137488|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137489|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137490|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137491|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137492|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137493|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137494|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137495|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137496|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137497|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
137498|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
137505|NCT01424072|B2|Baseline|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137506|NCT01424072|B1|Baseline|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137507|NCT01424072|P3|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137508|NCT01424072|P2|Participant Flow|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137509|NCT01424072|P1|Participant Flow|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137510|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137511|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137512|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137513|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137514|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137515|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137516|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137517|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137518|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137519|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137520|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137521|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137522|NCT01424072|E3|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
137523|NCT01424072|E2|Reported Event|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
137524|NCT01424072|E1|Reported Event|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
137525|NCT01424033|B1|Baseline|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
137526|NCT01424033|P1|Participant Flow|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
137692|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137527|NCT01424033|O1|Outcome|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
137528|NCT01424033|E1|Reported Event|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
137529|NCT01423916|B4|Baseline|Total|Total of all reporting groups
137530|NCT01423916|B3|Baseline|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137531|NCT01423916|B2|Baseline|Brexpiprzole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137532|NCT01423916|B1|Baseline|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137533|NCT01423916|P3|Participant Flow|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137534|NCT01423916|P2|Participant Flow|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137535|NCT01423916|P1|Participant Flow|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137536|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137537|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137538|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137539|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137540|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137541|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137542|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137543|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137544|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137545|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137546|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137547|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137548|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137549|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137550|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137551|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137552|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137553|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137554|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137555|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137556|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137557|NCT01423916|O3|Outcome|Moxifloaxcin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137799|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137558|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137559|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137560|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137561|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137562|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137563|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137564|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137565|NCT01423916|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137566|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137567|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137568|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137569|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137570|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137571|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137572|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137573|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137574|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137575|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137576|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137577|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137578|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137579|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137580|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137581|NCT01423916|O3|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137582|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137583|NCT01423916|O1|Outcome|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
137584|NCT01423916|E4|Reported Event|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
137585|NCT01423916|E3|Reported Event|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
137586|NCT01423916|E2|Reported Event|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137587|NCT01423916|E1|Reported Event|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
137588|NCT01423773|B1|Baseline|Overall|Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
137589|NCT01423773|P2|Participant Flow|Lotrafilcon A Control, Then Lotrafilcon A Test|Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
137590|NCT01423773|P1|Participant Flow|Lotrafilcon A Test, Then Lotrafilcon A Control|Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
137591|NCT01423773|O2|Outcome|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
137592|NCT01423773|O1|Outcome|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
137593|NCT01423773|E2|Reported Event|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
137594|NCT01423773|E1|Reported Event|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
137595|NCT01423760|B3|Baseline|Total|Total of all reporting groups
137596|NCT01423760|B2|Baseline|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
137597|NCT01423760|B1|Baseline|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
137598|NCT01423760|P2|Participant Flow|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
137599|NCT01423760|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
137600|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137601|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137602|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137603|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137604|NCT01423760|E2|Reported Event|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137605|NCT01423760|E1|Reported Event|NSCLC|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
137606|NCT01423617|B3|Baseline|Total|Total of all reporting groups
137607|NCT01423617|B2|Baseline|Placebo|Placebo: 3 tablets 2 times daily
137608|NCT01423617|B1|Baseline|Zenoctil|Zenoctil: 3 tablets 2 times daily
137609|NCT01423617|P2|Participant Flow|Placebo|Placebo: 3 tablets 2 times daily
137610|NCT01423617|P1|Participant Flow|Zenoctil|Zenoctil: 3 tablets 2 times daily
137611|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
137612|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
137613|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
137614|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
137615|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
137616|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
137617|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
137618|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
137619|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
137620|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
137621|NCT01423617|E2|Reported Event|Placebo|Placebo: 3 tablets 2 times daily
137622|NCT01423617|E1|Reported Event|Zenoctil|Zenoctil: 3 tablets 2 times daily
137623|NCT01423604|B4|Baseline|Total|Total of all reporting groups
137624|NCT01423604|B3|Baseline|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137625|NCT01423604|B2|Baseline|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137626|NCT01423604|B1|Baseline|Ruxolitinib - Safety Run-In|Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
137627|NCT01423604|P2|Participant Flow|Placebo|Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137628|NCT01423604|P1|Participant Flow|Ruxolitinib|"Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.~Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID])."
137629|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137630|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137631|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137632|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137633|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137634|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137635|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137636|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137637|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137638|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137639|NCT01423604|E3|Reported Event|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137640|NCT01423604|E2|Reported Event|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
137641|NCT01423604|E1|Reported Event|Ruxolitinib (Safety Run-In)|Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID
137642|NCT01423253|B1|Baseline|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137643|NCT01423253|P1|Participant Flow|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137644|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137645|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137646|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137647|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137648|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137649|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137650|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137651|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137652|NCT01423253|E1|Reported Event|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
137653|NCT01423162|B3|Baseline|Total|Total of all reporting groups
137654|NCT01423162|B2|Baseline|Drink Without Vit C Then Drink With Vit C|Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
137655|NCT01423162|B1|Baseline|Drink With Vit C Then Drink Without Vit C|Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
137656|NCT01423162|P2|Participant Flow|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
137657|NCT01423162|P1|Participant Flow|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
137658|NCT01423162|O2|Outcome|Fortified Oat Drink Without Vitamin C|
137659|NCT01423162|O1|Outcome|Fortified Oat Drink With Vitamin C|
137660|NCT01423162|E2|Reported Event|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
137661|NCT01423162|E1|Reported Event|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
137662|NCT01423084|B3|Baseline|Total|Total of all reporting groups
137663|NCT01423084|B2|Baseline|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137664|NCT01423084|B1|Baseline|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137665|NCT01423084|P2|Participant Flow|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137666|NCT01423084|P1|Participant Flow|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137667|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137668|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137669|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137670|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137671|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137672|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137673|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137674|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137675|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137676|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137677|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137678|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137679|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137680|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137681|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137682|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137683|NCT01423084|O2|Outcome|MenB Lot 2|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137684|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137685|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137686|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137687|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137688|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137689|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137690|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137800|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137693|NCT01423084|E2|Reported Event|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
137694|NCT01423084|E1|Reported Event|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
137695|NCT01422889|B1|Baseline|ION Registry|The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
137696|NCT01422889|P1|Participant Flow|ION Registry|The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
137697|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
137698|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
137699|NCT01422889|E1|Reported Event|ION Registry|The ION Registry population will contain the first 1115 consecutive, consenting patients
137700|NCT01422876|B11|Baseline|Total|Total of all reporting groups
137701|NCT01422876|B10|Baseline|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137702|NCT01422876|B9|Baseline|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137703|NCT01422876|B8|Baseline|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137704|NCT01422876|B7|Baseline|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137705|NCT01422876|B6|Baseline|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137706|NCT01422876|B5|Baseline|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137707|NCT01422876|B4|Baseline|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137708|NCT01422876|B3|Baseline|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137709|NCT01422876|B2|Baseline|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137710|NCT01422876|B1|Baseline|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137711|NCT01422876|P10|Participant Flow|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137712|NCT01422876|P9|Participant Flow|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137713|NCT01422876|P8|Participant Flow|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137714|NCT01422876|P7|Participant Flow|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137715|NCT01422876|P6|Participant Flow|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137716|NCT01422876|P5|Participant Flow|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137717|NCT01422876|P4|Participant Flow|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137718|NCT01422876|P3|Participant Flow|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137719|NCT01422876|P2|Participant Flow|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137720|NCT01422876|P1|Participant Flow|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
137721|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137722|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137723|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137724|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137725|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137726|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137727|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137728|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137729|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137730|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137731|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137732|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137733|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137734|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137735|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137736|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137737|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137801|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
137738|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137739|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137740|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137741|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137742|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137743|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137744|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137745|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137746|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137747|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137748|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137749|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137750|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137751|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137752|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Ora"
137753|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137754|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137755|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137756|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
137757|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
137802|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137803|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137758|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
137759|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
137760|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
137761|NCT01422876|E5|Reported Event|Linagliptin 5 mg|Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
137762|NCT01422876|E4|Reported Event|Empagliflozin 10 mg|Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
137763|NCT01422876|E3|Reported Event|Empagliflozin 25 mg|Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
137764|NCT01422876|E2|Reported Event|Empagliflozin 10 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
137765|NCT01422876|E1|Reported Event|Empagliflozin 25 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
137766|NCT01422850|B1|Baseline|ALECSAT|
137767|NCT01422850|P1|Participant Flow|ALECSAT|After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
137768|NCT01422850|O1|Outcome|ALECSAT|
137769|NCT01422850|O1|Outcome|Trends Towards Possible Treatment Response|No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.
137770|NCT01422850|O1|Outcome|ALCESAT|
137771|NCT01422850|E1|Reported Event|ALECSAT|
137772|NCT01422824|B1|Baseline|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
137773|NCT01422824|P1|Participant Flow|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
137774|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
137775|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
137776|NCT01422824|E1|Reported Event|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
137777|NCT01422720|B1|Baseline|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
137778|NCT01422720|P1|Participant Flow|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
137779|NCT01422720|O4|Outcome|PPS- Treatment Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
137780|NCT01422720|O3|Outcome|PPS - Baseline Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
137781|NCT01422720|O2|Outcome|FAS - Treatment Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
137782|NCT01422720|O1|Outcome|FAS - Baseline Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
137783|NCT01422720|O1|Outcome|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
137784|NCT01422720|E1|Reported Event|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
137785|NCT01422538|B4|Baseline|Total|Total of all reporting groups
137786|NCT01422538|B3|Baseline|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
137787|NCT01422538|B2|Baseline|Group B|Subjects received Sculptra® treatment only
137788|NCT01422538|B1|Baseline|Group A|Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
137789|NCT01422538|P3|Participant Flow|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137790|NCT01422538|P2|Participant Flow|Group B|Subjects received Sculptra® treatment only
137791|NCT01422538|P1|Participant Flow|Group A|Subjects received Ultherapy® Treatment only.
137792|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137793|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
137794|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137795|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137796|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
137797|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137798|NCT01422538|O2|Outcome|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
137806|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
137807|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
137808|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
137809|NCT01422538|E3|Reported Event|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
137810|NCT01422538|E2|Reported Event|Group B|Subjects received Sculptra® only.
137811|NCT01422538|E1|Reported Event|Group A|Subjects received Ultherapy® Treatment only.
137812|NCT01422434|B4|Baseline|Total|Total of all reporting groups
137813|NCT01422434|B3|Baseline|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137814|NCT01422434|B2|Baseline|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137815|NCT01422434|B1|Baseline|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137816|NCT01422434|P3|Participant Flow|Rinderon® - DP Ointment (Betamethasone Dipropionate)|"Applied once daily for 4 weeks~Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks."
137817|NCT01422434|P2|Participant Flow|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137818|NCT01422434|P1|Participant Flow|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137819|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137820|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137821|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137822|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137823|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137824|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137825|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137826|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137827|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137828|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137829|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137830|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137831|NCT01422434|E3|Reported Event|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
137832|NCT01422434|E2|Reported Event|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
137833|NCT01422434|E1|Reported Event|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
137834|NCT01422382|B1|Baseline|All Subjects|All randomized subjects.
137835|NCT01422382|P1|Participant Flow|All Subjects|All randomized subjects.
137836|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
137837|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
137838|NCT01422382|E1|Reported Event|All Subjects|All randomized subjects.
137839|NCT01422369|B1|Baseline|All Subjects|All randomized subjects
137840|NCT01422369|P1|Participant Flow|All Subjects|All randomized subjects
137841|NCT01422369|O1|Outcome|All Subjects|All randomized subjects
137842|NCT01422369|O1|Outcome|NK-104|NK-104 4mg once daily (QD)
137843|NCT01422369|E1|Reported Event|All Subjects|All randomized subjects
137844|NCT01422356|B1|Baseline|12 Month Cohort|
137845|NCT01422356|P1|Participant Flow|12 Month Cohort|16-20 year old males
137846|NCT01422356|O1|Outcome|Baseline Prevalence|
137847|NCT01422356|E1|Reported Event|12 Month Cohort|
137848|NCT01422304|B3|Baseline|Total|Total of all reporting groups
137849|NCT01422304|B2|Baseline|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137850|NCT01422304|B1|Baseline|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137864|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137851|NCT01422304|P2|Participant Flow|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137852|NCT01422304|P1|Participant Flow|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137853|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137854|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137855|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137856|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137857|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137858|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137859|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137860|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137861|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137862|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137863|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137953|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137954|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137955|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137956|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137865|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137866|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137867|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137868|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137869|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137870|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137871|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137872|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137873|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137874|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137875|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137876|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137877|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137957|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137958|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137959|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137960|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137878|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137879|NCT01422304|E2|Reported Event|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
137880|NCT01422304|E1|Reported Event|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
137881|NCT01422239|B3|Baseline|Total|Total of all reporting groups
137882|NCT01422239|B2|Baseline|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
137883|NCT01422239|B1|Baseline|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
137884|NCT01422239|P2|Participant Flow|Standard Behavioral Counseling|The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
137885|NCT01422239|P1|Participant Flow|Tailored Behavioral Counseling|The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
137886|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
137887|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
137888|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
137889|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
137890|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
137891|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
137961|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137962|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137963|NCT01422213|E3|Reported Event|Vortioxetine 20 mg|
137892|NCT01422239|E2|Reported Event|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
137893|NCT01422239|E1|Reported Event|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
137894|NCT01422226|B3|Baseline|Total|Total of all reporting groups
137895|NCT01422226|B2|Baseline|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
137896|NCT01422226|B1|Baseline|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
137897|NCT01422226|P2|Participant Flow|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
137898|NCT01422226|P1|Participant Flow|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
137899|NCT01422226|O2|Outcome|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
137900|NCT01422226|O1|Outcome|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
137901|NCT01422226|E2|Reported Event|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
137902|NCT01422226|E1|Reported Event|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
137903|NCT01422213|B4|Baseline|Total|Total of all reporting groups
137904|NCT01422213|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137905|NCT01422213|B2|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137906|NCT01422213|B1|Baseline|Placebo|capsules, daily, orally
137907|NCT01422213|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets; daily; orally
137908|NCT01422213|P2|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; daily; orally
137909|NCT01422213|P1|Participant Flow|Placebo|capsules; daily; orally
137910|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137911|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137912|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137913|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137914|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137915|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137916|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137917|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137918|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137919|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137920|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137921|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137922|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137923|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137924|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137925|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137926|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137927|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137928|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137929|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137930|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137931|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137932|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137933|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137934|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137935|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137936|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137937|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137938|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137939|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137940|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137941|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137942|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137943|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137944|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137945|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137946|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137947|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137948|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137949|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137950|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
137951|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
137952|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
137967|NCT01422187|B3|Baseline|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137968|NCT01422187|B2|Baseline|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137969|NCT01422187|B1|Baseline|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137970|NCT01422187|P3|Participant Flow|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137971|NCT01422187|P2|Participant Flow|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137972|NCT01422187|P1|Participant Flow|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137973|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137974|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137975|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137976|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137977|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137978|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137979|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137980|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137981|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137982|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137983|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137984|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137985|NCT01422187|E3|Reported Event|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137986|NCT01422187|E2|Reported Event|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137987|NCT01422187|E1|Reported Event|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
137988|NCT01422070|B3|Baseline|Total|Total of all reporting groups
137989|NCT01422070|B2|Baseline|Units Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
137990|NCT01422070|B1|Baseline|Units With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
137991|NCT01422070|P2|Participant Flow|Units in Hospitals Without Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
137992|NCT01422070|P1|Participant Flow|Units in Hospitals With Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit
137993|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
137994|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
137995|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
137996|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
137997|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
137998|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
137999|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
138000|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
138001|NCT01422070|E1|Reported Event|Adverse Events Not Collected|Adverse events were not collected
138002|NCT01421667|B5|Baseline|Total|Total of all reporting groups
138003|NCT01421667|B4|Baseline|CD30+ DLBCL, BV+R|
138004|NCT01421667|B3|Baseline|CD30u DLBCL, BV|
138005|NCT01421667|B2|Baseline|CD30+ B-Cell NHL, BV|
138006|NCT01421667|B1|Baseline|CD30+ T-Cell NHL, BV|
138007|NCT01421667|P4|Participant Flow|CD30+ DLBCL, BV+R|Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
138008|NCT01421667|P3|Participant Flow|CD30u DLBCL, BV|Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
138073|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
153929|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
138009|NCT01421667|P2|Participant Flow|CD30+ B-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
138010|NCT01421667|P1|Participant Flow|CD30+ T-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
138011|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138012|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138013|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138014|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138015|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138016|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138017|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138018|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138019|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138020|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138021|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138022|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138023|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138024|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138025|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138026|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
138027|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
138028|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138029|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
138030|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
138031|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
138032|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138033|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
138034|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
138035|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
138036|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138037|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
138038|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
138039|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
138040|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138041|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
138042|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
138043|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
138044|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138045|NCT01421667|O5|Outcome|CD30+ DLBCL, BV+R|
138046|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
138047|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
138048|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
138049|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
138050|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|
138051|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
138052|NCT01421667|O4|Outcome|CD30u DLBCL, BV|Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
138053|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
138054|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
138055|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
138056|NCT01421667|E3|Reported Event|CD30+ DLBCL, BV+R|Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
138057|NCT01421667|E2|Reported Event|CD30u DLBCL, BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
138058|NCT01421667|E1|Reported Event|CD30+ NHL (T-Cell and B-Cell), BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
138059|NCT01421654|B3|Baseline|Total|Total of all reporting groups
138060|NCT01421654|B2|Baseline|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
138061|NCT01421654|B1|Baseline|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
138062|NCT01421654|P2|Participant Flow|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
138063|NCT01421654|P1|Participant Flow|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
138064|NCT01421654|O2|Outcome|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
138065|NCT01421654|O1|Outcome|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
138066|NCT01421654|E2|Reported Event|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
138067|NCT01421654|E1|Reported Event|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
138068|NCT01421641|B3|Baseline|Total|Total of all reporting groups
138069|NCT01421641|B2|Baseline|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
138070|NCT01421641|B1|Baseline|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138071|NCT01421641|P2|Participant Flow|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
138072|NCT01421641|P1|Participant Flow|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138074|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138075|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
138076|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138077|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
138078|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138079|NCT01421641|E2|Reported Event|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
138080|NCT01421641|E1|Reported Event|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
138081|NCT01421589|B1|Baseline|Growth Hormone|Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138082|NCT01421589|P1|Participant Flow|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138083|NCT01421589|O1|Outcome|Growth Hormone|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138084|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138085|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138086|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138087|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138088|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138089|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138090|NCT01421589|E1|Reported Event|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
138091|NCT01421511|B3|Baseline|Total|Total of all reporting groups
138092|NCT01421511|B2|Baseline|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138093|NCT01421511|B1|Baseline|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
138094|NCT01421511|P2|Participant Flow|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138095|NCT01421511|P1|Participant Flow|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138096|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138097|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138098|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138099|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138100|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138101|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138102|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138103|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138104|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138105|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138106|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138107|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138108|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138109|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138110|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138111|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
138112|NCT01421511|E2|Reported Event|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
138113|NCT01421511|E1|Reported Event|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
138114|NCT01421472|B5|Baseline|Total|Total of all reporting groups
138115|NCT01421472|B4|Baseline|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138116|NCT01421472|B3|Baseline|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138408|NCT01419314|E2|Reported Event|Splint Liner|Night time application of lower extremity splint liner
138117|NCT01421472|B2|Baseline|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138118|NCT01421472|B1|Baseline|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138119|NCT01421472|P4|Participant Flow|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138120|NCT01421472|P3|Participant Flow|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138121|NCT01421472|P2|Participant Flow|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138122|NCT01421472|P1|Participant Flow|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138123|NCT01421472|O4|Outcome|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138124|NCT01421472|O3|Outcome|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138125|NCT01421472|O2|Outcome|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138126|NCT01421472|O1|Outcome|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138127|NCT01421472|E4|Reported Event|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138128|NCT01421472|E3|Reported Event|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138129|NCT01421472|E2|Reported Event|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
138130|NCT01421472|E1|Reported Event|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
138131|NCT01421459|B3|Baseline|Total|Total of all reporting groups
138132|NCT01421459|B2|Baseline|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138133|NCT01421459|B1|Baseline|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138134|NCT01421459|P2|Participant Flow|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138135|NCT01421459|P1|Participant Flow|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138136|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138137|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138138|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138139|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138140|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138141|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138608|NCT01417481|B3|Baseline|Total|Total of all reporting groups
138142|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138143|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138144|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138145|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138146|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138147|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138148|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138149|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138150|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138151|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138152|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138153|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138154|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138155|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138156|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138157|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138158|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138159|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138160|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138161|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138162|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138163|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138164|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138165|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138166|NCT01421459|E2|Reported Event|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
138167|NCT01421459|E1|Reported Event|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
138168|NCT01421355|B1|Baseline|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
138169|NCT01421355|P1|Participant Flow|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
138170|NCT01421355|O1|Outcome|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
138278|NCT01420848|P2|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
138171|NCT01421355|E1|Reported Event|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
138172|NCT01421303|B1|Baseline|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138173|NCT01421303|P1|Participant Flow|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138174|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138175|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138176|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138177|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138178|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138179|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138180|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138181|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138182|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138183|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138184|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138185|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138186|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138187|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138188|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138189|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138190|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138191|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138192|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138193|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138194|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138195|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138196|NCT01421303|E1|Reported Event|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
138197|NCT01421277|B3|Baseline|Total|Total of all reporting groups
138198|NCT01421277|B2|Baseline|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138199|NCT01421277|B1|Baseline|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138200|NCT01421277|P2|Participant Flow|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138201|NCT01421277|P1|Participant Flow|Participants Enrolled in Protocol Version (V)1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138202|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138203|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138204|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138205|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138206|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138207|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138208|NCT01421277|E2|Reported Event|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
138209|NCT01421277|E1|Reported Event|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
138210|NCT01421147|B3|Baseline|Total|Total of all reporting groups
138211|NCT01421147|B2|Baseline|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138212|NCT01421147|B1|Baseline|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138213|NCT01421147|P2|Participant Flow|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138214|NCT01421147|P1|Participant Flow|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138215|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138216|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138336|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138217|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138218|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138219|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138220|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138221|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138222|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138223|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138224|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138225|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138226|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138227|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138228|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138229|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138230|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138231|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138232|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138337|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138233|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138234|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138235|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138236|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138237|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138238|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138239|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138240|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138241|NCT01421147|E2|Reported Event|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138242|NCT01421147|E1|Reported Event|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
138243|NCT01421134|B3|Baseline|Total|Total of all reporting groups
138244|NCT01421134|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
138245|NCT01421134|B1|Baseline|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138246|NCT01421134|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
138247|NCT01421134|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138248|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138249|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138250|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138251|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138252|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138253|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138254|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138255|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138256|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138257|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138258|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138259|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138260|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
138261|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138262|NCT01421134|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
138263|NCT01421134|E1|Reported Event|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
138264|NCT01420926|B3|Baseline|Total|Total of all reporting groups
138311|NCT01420081|B3|Baseline|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138265|NCT01420926|B2|Baseline|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138266|NCT01420926|B1|Baseline|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138267|NCT01420926|P2|Participant Flow|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138268|NCT01420926|P1|Participant Flow|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138269|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138270|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138271|NCT01420926|E2|Reported Event|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138272|NCT01420926|E1|Reported Event|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
138273|NCT01420848|B4|Baseline|Total|Total of all reporting groups
138274|NCT01420848|B3|Baseline|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
138275|NCT01420848|B2|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
138276|NCT01420848|B1|Baseline|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
138277|NCT01420848|P3|Participant Flow|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
138279|NCT01420848|P1|Participant Flow|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
138280|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
138281|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
138282|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
138283|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
138284|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
138285|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
138286|NCT01420848|E3|Reported Event|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
138287|NCT01420848|E2|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
138288|NCT01420848|E1|Reported Event|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
138289|NCT01420289|B3|Baseline|Total|Total of all reporting groups
138290|NCT01420289|B2|Baseline|Excercise|Walking on a graded treadmill for 45 minutes once daily
138291|NCT01420289|B1|Baseline|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138292|NCT01420289|P2|Participant Flow|Excercise|Walking on a graded treadmill for 45 minutes once daily
138293|NCT01420289|P1|Participant Flow|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138294|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
138295|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138296|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
138297|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138298|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
138299|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138300|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
138301|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138302|NCT01420289|E2|Reported Event|Excercise|Walking on a graded treadmill for 45 minutes once daily
138303|NCT01420289|E1|Reported Event|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
138304|NCT01420081|B10|Baseline|Total|Total of all reporting groups
138305|NCT01420081|B9|Baseline|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138306|NCT01420081|B8|Baseline|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138307|NCT01420081|B7|Baseline|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138308|NCT01420081|B6|Baseline|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138309|NCT01420081|B5|Baseline|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138310|NCT01420081|B4|Baseline|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138312|NCT01420081|B2|Baseline|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138313|NCT01420081|B1|Baseline|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138314|NCT01420081|P9|Participant Flow|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138315|NCT01420081|P8|Participant Flow|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138316|NCT01420081|P7|Participant Flow|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138317|NCT01420081|P6|Participant Flow|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138318|NCT01420081|P5|Participant Flow|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138319|NCT01420081|P4|Participant Flow|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138320|NCT01420081|P3|Participant Flow|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138321|NCT01420081|P2|Participant Flow|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138322|NCT01420081|P1|Participant Flow|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138323|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138324|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138325|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138326|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138327|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138328|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138329|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138330|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138331|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138332|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138333|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138334|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138335|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138405|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
138338|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138339|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138340|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138341|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138342|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138343|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
138344|NCT01420081|E9|Reported Event|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138345|NCT01420081|E8|Reported Event|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138346|NCT01420081|E7|Reported Event|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138347|NCT01420081|E6|Reported Event|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138348|NCT01420081|E5|Reported Event|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138349|NCT01420081|E4|Reported Event|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138350|NCT01420081|E3|Reported Event|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138351|NCT01420081|E2|Reported Event|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
138352|NCT01420081|E1|Reported Event|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
138353|NCT01419977|B3|Baseline|Total|Total of all reporting groups
138354|NCT01419977|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138355|NCT01419977|B1|Baseline|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138356|NCT01419977|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138357|NCT01419977|P1|Participant Flow|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138358|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138359|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138360|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138361|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138362|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138363|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138364|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138365|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138366|NCT01419977|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
138367|NCT01419977|E1|Reported Event|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
138406|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
138368|NCT01419769|B1|Baseline|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138369|NCT01419769|P1|Participant Flow|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138370|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138371|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138372|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138373|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138374|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138375|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138376|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138660|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
138377|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138378|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138379|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138380|NCT01419769|E1|Reported Event|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
138381|NCT01419639|B1|Baseline|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138382|NCT01419639|P1|Participant Flow|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138383|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138384|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138385|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138386|NCT01419639|E1|Reported Event|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
138387|NCT01419314|B3|Baseline|Total|Total of all reporting groups
138388|NCT01419314|B2|Baseline|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
138389|NCT01419314|B1|Baseline|LE Splints Group|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
138390|NCT01419314|P2|Participant Flow|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
138391|NCT01419314|P1|Participant Flow|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
138392|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
138393|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138394|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
138395|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138396|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
138397|NCT01419314|O1|Outcome|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
138398|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
138399|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
138400|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
138401|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138402|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
138403|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138404|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
138407|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138409|NCT01419314|E1|Reported Event|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
138410|NCT01419249|B3|Baseline|Total|Total of all reporting groups
138411|NCT01419249|B2|Baseline|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138412|NCT01419249|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138413|NCT01419249|P2|Participant Flow|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138414|NCT01419249|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138415|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138416|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138417|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138418|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138419|NCT01419249|O1|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138420|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138421|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138422|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138423|NCT01419249|E2|Reported Event|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138424|NCT01419249|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
138425|NCT01419236|B3|Baseline|Total|Total of all reporting groups
138426|NCT01419236|B2|Baseline|Placebo|Placebo solution applied topically once daily for 16 weeks.
138427|NCT01419236|B1|Baseline|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138428|NCT01419236|P2|Participant Flow|Placebo|Placebo solution applied topically once daily for 16 weeks.
138429|NCT01419236|P1|Participant Flow|Testosterone Solution 2%|Testosterone solution 2% [60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day] for 16 weeks.
138430|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138431|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138432|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138433|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138434|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
155036|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
138435|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138436|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138437|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138438|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138439|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138440|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138441|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138442|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138443|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138444|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138445|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138446|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
138447|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138448|NCT01419236|E2|Reported Event|Placebo|Placebo solution applied topically once daily for 16 weeks.
138449|NCT01419236|E1|Reported Event|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
138450|NCT01419197|B3|Baseline|Total|Total of all reporting groups
138451|NCT01419197|B2|Baseline|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138452|NCT01419197|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138453|NCT01419197|P2|Participant Flow|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.
138454|NCT01419197|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138455|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138456|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138457|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138458|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138459|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138460|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138461|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138462|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138463|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138464|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138465|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138466|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138467|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138468|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138469|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138470|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138471|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138472|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138473|NCT01419197|E3|Reported Event|Trastuzumab Emtansine - Post TPC Treatment Switch|Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138474|NCT01419197|E2|Reported Event|Treatment of Physician’s Choice (TPC)|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
138475|NCT01419197|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
138476|NCT01419184|B3|Baseline|Total|Total of all reporting groups
138477|NCT01419184|B2|Baseline|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138478|NCT01419184|B1|Baseline|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138479|NCT01419184|P2|Participant Flow|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed per investigator’s discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
138480|NCT01419184|P1|Participant Flow|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138481|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138482|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138483|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138484|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138485|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138486|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138487|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138488|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138489|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138490|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138491|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138492|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138493|NCT01419184|E2|Reported Event|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138494|NCT01419184|E1|Reported Event|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
138495|NCT01419171|B1|Baseline|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138496|NCT01419171|P1|Participant Flow|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138497|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138498|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138499|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138500|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138501|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138502|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138503|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138504|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138505|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138506|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138507|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138508|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138509|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138510|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138511|NCT01419171|E1|Reported Event|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
138512|NCT01419028|B1|Baseline|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
138513|NCT01419028|P1|Participant Flow|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
138514|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
138515|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
138516|NCT01419028|E1|Reported Event|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
138517|NCT01418937|B1|Baseline|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138518|NCT01418937|P1|Participant Flow|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138519|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138520|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138521|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138522|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138523|NCT01418937|E1|Reported Event|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
138524|NCT01418703|B3|Baseline|Total|Total of all reporting groups
138525|NCT01418703|B2|Baseline|Enhanced Control to Range (eCTR)|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual’s conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
138526|NCT01418703|B1|Baseline|Standard Control to Range (sCTR)|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
138527|NCT01418703|P4|Participant Flow|eCTR Closed-Loop First, Then Open-Loop|"Participants completed open-loop admission, then completed eCTR closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR."
138528|NCT01418703|P3|Participant Flow|Open-Loop First, Then eCTR Closed-Loop|"Participants completed open-loop admission, then completed eCTR (Enhanced Control to Range) closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC (model predictive control) algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the clinical research center (CRC) kitchen but automatically calculated by eCTR."
138529|NCT01418703|P2|Participant Flow|sCTR Closed-Loop First, Then Open-Loop|"Participants completed sCTR Closed-Loop admission, then completed open-loop admission.~The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour."
138530|NCT01418703|P1|Participant Flow|Open-Loop First, Then sCTR Closed-Loop|"Completed open-loop, then sCTR (Standard Control to Range ) Closed-Loop admission.~The two modules of sCTR are the SSM (safety supervision module) and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM (continuous glucose monitor) and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g. body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII (continuous subcutaneous insulin infusion) parameters."
138531|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
138532|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
138657|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
138533|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
138534|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
138535|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
138536|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
138537|NCT01418703|E3|Reported Event|eCTR Closed-Loop Control|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
138538|NCT01418703|E2|Reported Event|sCTR Closed-Loop Control|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
138539|NCT01418703|E1|Reported Event|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
138540|NCT01418365|B3|Baseline|Total|Total of all reporting groups
138541|NCT01418365|B2|Baseline|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
138542|NCT01418365|B1|Baseline|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
138543|NCT01418365|P2|Participant Flow|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
138544|NCT01418365|P1|Participant Flow|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
138545|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
138546|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
139743|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
138547|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
138548|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
138549|NCT01418365|E2|Reported Event|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
138550|NCT01418365|E1|Reported Event|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
138551|NCT01418209|B4|Baseline|Total|Total of all reporting groups
138552|NCT01418209|B3|Baseline|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138553|NCT01418209|B2|Baseline|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138554|NCT01418209|B1|Baseline|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138555|NCT01418209|P3|Participant Flow|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138556|NCT01418209|P2|Participant Flow|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138557|NCT01418209|P1|Participant Flow|Low-dose 17-ß-Estradiol With Progesterone Taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
138558|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138559|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138560|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138561|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138562|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138563|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138564|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138609|NCT01417481|B2|Baseline|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
138610|NCT01417481|B1|Baseline|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
138565|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138566|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138567|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138568|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138569|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138570|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138571|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138572|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138573|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138574|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138575|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138576|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138577|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138578|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138579|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138611|NCT01417481|P2|Participant Flow|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
138658|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
138580|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138581|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138582|NCT01418209|E3|Reported Event|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
138583|NCT01418209|E2|Reported Event|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
138584|NCT01418209|E1|Reported Event|Low-dose 17-ß-estradiol|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
138585|NCT01418001|B1|Baseline|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
138586|NCT01418001|P1|Participant Flow|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
138587|NCT01418001|O1|Outcome|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
138588|NCT01418001|E1|Reported Event|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
138589|NCT01417936|B1|Baseline|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138590|NCT01417936|P1|Participant Flow|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138591|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138592|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138593|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138594|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138595|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138596|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138597|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138598|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138599|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138600|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138601|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138602|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138603|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138604|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138605|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138606|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138607|NCT01417936|E1|Reported Event|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
138612|NCT01417481|P1|Participant Flow|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
138613|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138614|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138615|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138616|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138617|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138618|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138619|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138620|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138621|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138622|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138623|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138624|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138625|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138626|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138627|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138628|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138629|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138630|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138631|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
138632|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
138633|NCT01417481|E2|Reported Event|Placebo|Patients received a daily oral supplement of sugar glass at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
138634|NCT01417481|E1|Reported Event|Glycine|Patients received a daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
138635|NCT01417455|B9|Baseline|Total|Total of all reporting groups
138636|NCT01417455|B8|Baseline|Controls|Healthy donors age and sex matched to the patients
138637|NCT01417455|B7|Baseline|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
138638|NCT01417455|B6|Baseline|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
138639|NCT01417455|B5|Baseline|Ankylosing Spondylitis|Active Ankylosing Spondylitis
138640|NCT01417455|B4|Baseline|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
138641|NCT01417455|B3|Baseline|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
138642|NCT01417455|B2|Baseline|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
138643|NCT01417455|B1|Baseline|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
138644|NCT01417455|P8|Participant Flow|Controls|Healthy donors age and sex matched to the patients
138645|NCT01417455|P7|Participant Flow|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
138646|NCT01417455|P6|Participant Flow|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
138647|NCT01417455|P5|Participant Flow|Ankylosing Spondylitis|Active Ankylosing Spondylitis
138648|NCT01417455|P4|Participant Flow|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
138649|NCT01417455|P3|Participant Flow|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
138650|NCT01417455|P2|Participant Flow|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
138651|NCT01417455|P1|Participant Flow|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
138652|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
138653|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
138654|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
138655|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
138656|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
138659|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
138661|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
138662|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
138663|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
138664|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
138665|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
138666|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
138667|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
138668|NCT01417455|E8|Reported Event|Controls|Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.
138669|NCT01417455|E7|Reported Event|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
138670|NCT01417455|E6|Reported Event|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
138671|NCT01417455|E5|Reported Event|Ankylosing Spondylitis|Active Ankylosing Spondylitis
138672|NCT01417455|E4|Reported Event|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
138673|NCT01417455|E3|Reported Event|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
138674|NCT01417455|E2|Reported Event|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
138675|NCT01417455|E1|Reported Event|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
138676|NCT01417377|B1|Baseline|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138677|NCT01417377|P1|Participant Flow|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138678|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138679|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138680|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138681|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138682|NCT01417377|E1|Reported Event|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
138683|NCT01417195|B3|Baseline|Total|Total of all reporting groups
138684|NCT01417195|B2|Baseline|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138685|NCT01417195|B1|Baseline|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138686|NCT01417195|P2|Participant Flow|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138687|NCT01417195|P1|Participant Flow|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138688|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138689|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138690|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138715|NCT01416610|B1|Baseline|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138981|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
138691|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138692|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138693|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138694|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138695|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138696|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138697|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138698|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138699|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138700|NCT01417195|E2|Reported Event|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
138701|NCT01417195|E1|Reported Event|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
138702|NCT01417104|B3|Baseline|Total|Total of all reporting groups
138703|NCT01417104|B2|Baseline|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138704|NCT01417104|B1|Baseline|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138705|NCT01417104|P2|Participant Flow|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138706|NCT01417104|P1|Participant Flow|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138707|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138708|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138709|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138710|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138711|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138712|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138713|NCT01417104|E2|Reported Event|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
138714|NCT01417104|E1|Reported Event|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
138716|NCT01416610|P1|Participant Flow|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138717|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138718|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138719|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138720|NCT01416610|O4|Outcome|End of Follow-up|End of Follow-up Visit
138721|NCT01416610|O3|Outcome|End of Treatment|End of Treatment Visit
138722|NCT01416610|O2|Outcome|Week 12|Week 12 Visit
138723|NCT01416610|O1|Outcome|Baseline|Baseline Visit
138724|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138725|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138726|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138727|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
138728|NCT01416610|E1|Reported Event|Safety Population|Participants who started treatment
138729|NCT01416571|B1|Baseline|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138730|NCT01416571|P1|Participant Flow|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138731|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138732|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138733|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138734|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138735|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138736|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138737|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138738|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138739|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138740|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138741|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138742|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138743|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138744|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138745|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138746|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138747|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138748|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138749|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138750|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138751|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138752|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138753|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138754|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138755|NCT01416571|E1|Reported Event|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
138756|NCT01416272|B1|Baseline|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138757|NCT01416272|P1|Participant Flow|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138758|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138759|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138760|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138761|NCT01416272|E1|Reported Event|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
138762|NCT01416155|B1|Baseline|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138763|NCT01416155|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions of natalizumab open label every 4 weeks
138764|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138765|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138766|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138767|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138768|NCT01416155|E1|Reported Event|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
138769|NCT01416142|B1|Baseline|All Eligible Baseline Participants|Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
138770|NCT01416142|P3|Participant Flow|PureVision2 HD|Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
138771|NCT01416142|P2|Participant Flow|Spectacles:PureVision2 HD|Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
138772|NCT01416142|P1|Participant Flow|PureVision2 HD:Spectacles|Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
138773|NCT01416142|O3|Outcome|No Difference|Participants reporting no difference between the PureVision2 HD lens and spectacles
138774|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
138775|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
138776|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
138777|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
138778|NCT01416142|E2|Reported Event|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
138779|NCT01416142|E1|Reported Event|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
138780|NCT01416129|B3|Baseline|Total|Total of all reporting groups
138781|NCT01416129|B2|Baseline|Active Comparator: Prosthetic Brimless Socket|This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
138782|NCT01416129|B1|Baseline|Active Comparator: Prosthetic Socket Standard of Care|This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
138783|NCT01416129|P2|Participant Flow|Prosthetic Socket (Experimental): Brimless Socket|5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
138784|NCT01416129|P1|Participant Flow|Standard of Care Prosthetic Socket (Ischial Containment)|In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
138785|NCT01416129|O2|Outcome|Active Comparator/Experimental: Prosthetic Brimless Socket|
138786|NCT01416129|O1|Outcome|Control Condition: Prosthetic Socket Standard of Care|
138787|NCT01416129|E2|Reported Event|Standard of Care Socket|
138788|NCT01416129|E1|Reported Event|Vacuum Assisted Socket|
138789|NCT01416025|B3|Baseline|Total|Total of all reporting groups
138790|NCT01416025|B2|Baseline|Standard Dosing|Standard doses of voriconazole will be used
138791|NCT01416025|B1|Baseline|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
138792|NCT01416025|P2|Participant Flow|Standard Dosing|Standard doses of voriconazole will be used
138793|NCT01416025|P1|Participant Flow|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
138794|NCT01416025|O2|Outcome|Standard Dosing|Standard doses of voriconazole will be used
138795|NCT01416025|O1|Outcome|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
138796|NCT01416025|E2|Reported Event|Standard Dosing|Standard doses of voriconazole will be used
138797|NCT01416025|E1|Reported Event|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
138798|NCT01415986|B1|Baseline|Group 1|Interstitial Photodynamic Therapy (I-PDT)
138799|NCT01415986|P1|Participant Flow|Group 1|Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
138800|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (I-PDT)
138801|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (PDT)
138802|NCT01415986|E1|Reported Event|Group 1|Interstitial Photodynamic Therapy (I-PDT)
138803|NCT01415960|B1|Baseline|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
138804|NCT01415960|P1|Participant Flow|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
138805|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138806|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138807|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138808|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138809|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138810|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138811|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
138812|NCT01415960|E1|Reported Event|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
138813|NCT01415921|B3|Baseline|Total|Total of all reporting groups
138814|NCT01415921|B2|Baseline|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138815|NCT01415921|B1|Baseline|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138841|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138816|NCT01415921|P2|Participant Flow|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138817|NCT01415921|P1|Participant Flow|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138818|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138819|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138820|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138821|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138822|NCT01415921|E2|Reported Event|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138823|NCT01415921|E1|Reported Event|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
138824|NCT01415908|B3|Baseline|Total|Total of all reporting groups
138825|NCT01415908|B2|Baseline|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138826|NCT01415908|B1|Baseline|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138827|NCT01415908|P2|Participant Flow|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138828|NCT01415908|P1|Participant Flow|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138829|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138830|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138831|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138832|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138833|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138834|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138835|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138836|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138837|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138838|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138839|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138840|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
155081|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
138842|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138843|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138844|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138845|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138846|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138847|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138848|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138849|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138850|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138851|NCT01415908|E2|Reported Event|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
138852|NCT01415908|E1|Reported Event|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
138853|NCT01415531|B3|Baseline|Total|Total of all reporting groups
138854|NCT01415531|B2|Baseline|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
138855|NCT01415531|B1|Baseline|Placebo|Dose-matched placebo
138856|NCT01415531|P2|Participant Flow|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
138857|NCT01415531|P1|Participant Flow|Placebo|Dose-matched placebo
138858|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
138859|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
138860|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
138861|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
138862|NCT01415531|E2|Reported Event|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
138863|NCT01415531|E1|Reported Event|Placebo|Dose-matched placebo
138864|NCT01415518|B3|Baseline|Total|Total of all reporting groups
138865|NCT01415518|B2|Baseline|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138866|NCT01415518|B1|Baseline|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138867|NCT01415518|P2|Participant Flow|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138868|NCT01415518|P1|Participant Flow|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138869|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138870|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138871|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138872|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138873|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138874|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138875|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138876|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138877|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138982|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
138878|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138879|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138880|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138881|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138882|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138883|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138884|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138885|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138886|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138887|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138888|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138889|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138890|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138891|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138892|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138893|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138894|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138895|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138896|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138897|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138898|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138899|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138900|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138901|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138902|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138903|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138904|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138905|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138941|NCT01414855|B1|Baseline|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138906|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138907|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138908|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138909|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138910|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138911|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138912|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138913|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138914|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138915|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138916|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138917|NCT01415518|E2|Reported Event|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138918|NCT01415518|E1|Reported Event|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
138919|NCT01415453|B1|Baseline|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
138920|NCT01415453|P1|Participant Flow|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
138921|NCT01415453|O1|Outcome|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
138922|NCT01415453|E1|Reported Event|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
138923|NCT01415401|B1|Baseline|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
138924|NCT01415401|P1|Participant Flow|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
138925|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
138926|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
138927|NCT01415401|E1|Reported Event|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
138928|NCT01415349|B1|Baseline|Safety Analysis Set|Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
138929|NCT01415349|P2|Participant Flow|SSP-002358 + Omeprazole First|A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
138930|NCT01415349|P1|Participant Flow|SSP-002358 First|A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
138931|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
138932|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
138933|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
138934|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
138935|NCT01415349|E2|Reported Event|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
138936|NCT01415349|E1|Reported Event|SSP-002358 Alone|All subjects that received only SSP-002358
138937|NCT01415232|B1|Baseline|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
138938|NCT01415232|P1|Participant Flow|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
138939|NCT01415232|O1|Outcome|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
138940|NCT01415232|E1|Reported Event|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
138980|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
155082|NCT01344460|O2|Outcome|Unenhanced MRA|
138942|NCT01414855|P1|Participant Flow|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
138943|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138944|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138945|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138946|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138947|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138948|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138949|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138950|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138951|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138952|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138953|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138954|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138955|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138956|NCT01414855|E1|Reported Event|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
138957|NCT01414634|B1|Baseline|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138958|NCT01414634|P8|Participant Flow|ETIMS 3x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138959|NCT01414634|P7|Participant Flow|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138960|NCT01414634|P6|Participant Flow|ETIMS 1x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138961|NCT01414634|P5|Participant Flow|ETIMS 5x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138962|NCT01414634|P4|Participant Flow|ETIMS 1x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138963|NCT01414634|P3|Participant Flow|ETIMS 1x10^7|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138964|NCT01414634|P2|Participant Flow|ETIMS 1x10^5|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138965|NCT01414634|P1|Participant Flow|ETIMS 1x10^3|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
138966|NCT01414634|O1|Outcome|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138967|NCT01414634|E8|Reported Event|ETIMS 3x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138968|NCT01414634|E7|Reported Event|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138969|NCT01414634|E6|Reported Event|ETIMS 1x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138970|NCT01414634|E5|Reported Event|ETIMS 5x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138971|NCT01414634|E4|Reported Event|ETIMS 1x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138972|NCT01414634|E3|Reported Event|ETIMS 1x10^7|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138973|NCT01414634|E2|Reported Event|ETIMS 1x10^5|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138974|NCT01414634|E1|Reported Event|ETIMS 1x10^3|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
138975|NCT01414413|B3|Baseline|Total|Total of all reporting groups
138976|NCT01414413|B2|Baseline|Clinic-based ART Assessment and Initiation|8466 adults resident in 3397 households
138977|NCT01414413|B1|Baseline|Home Assessment and Initiation of ART|8194 adults resident in 3213 households
138978|NCT01414413|P2|Participant Flow|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
138979|NCT01414413|P1|Participant Flow|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
155083|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
138983|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
138984|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
138985|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
138986|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
138987|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
138988|NCT01414413|E2|Reported Event|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
138989|NCT01414413|E1|Reported Event|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
138990|NCT01412983|B1|Baseline|Overall Study|All 99 participants in study
138991|NCT01412983|P2|Participant Flow|Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138992|NCT01412983|P1|Participant Flow|Bausch+Lomb Test Lens Then Ciba Vision Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138993|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138994|NCT01412983|O1|Outcome|Bausch + Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch + Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138995|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138996|NCT01412983|O1|Outcome|Bausch+Lomb Test Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138997|NCT01412983|E2|Reported Event|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138998|NCT01412983|E1|Reported Event|Bausch & Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
138999|NCT01414205|B3|Baseline|Total|Total of all reporting groups
139000|NCT01414205|B2|Baseline|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139001|NCT01414205|B1|Baseline|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139002|NCT01414205|P2|Participant Flow|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139003|NCT01414205|P1|Participant Flow|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139004|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139005|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139006|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139007|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139008|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139009|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139010|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
155084|NCT01344460|O2|Outcome|Unenhanced MRA|
139011|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139012|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139013|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139014|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139015|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139016|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139017|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139018|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139019|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139020|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139021|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139022|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139023|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139024|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139025|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139026|NCT01414205|E2|Reported Event|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139027|NCT01414205|E1|Reported Event|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
139028|NCT01414192|B5|Baseline|Total|Total of all reporting groups
139029|NCT01414192|B4|Baseline|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139030|NCT01414192|B3|Baseline|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139031|NCT01414192|B2|Baseline|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139032|NCT01414192|B1|Baseline|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139033|NCT01414192|P4|Participant Flow|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139034|NCT01414192|P3|Participant Flow|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139035|NCT01414192|P2|Participant Flow|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139036|NCT01414192|P1|Participant Flow|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139037|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139038|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139039|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139040|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139041|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139042|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139043|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139044|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139045|NCT01414192|O3|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139046|NCT01414192|O2|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139047|NCT01414192|O1|Outcome|Ezetimibe Monotherapy With or Without Prior Treatment|Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139048|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139049|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139050|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139051|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139052|NCT01414192|O3|Outcome|Ezetimibe Plus Statin or Ezetimibe/Simvastatin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139053|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139054|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139055|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139056|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139057|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139058|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139059|NCT01414192|E4|Reported Event|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
139060|NCT01414192|E3|Reported Event|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
139061|NCT01414192|E2|Reported Event|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139062|NCT01414192|E1|Reported Event|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
139063|NCT01414166|B3|Baseline|Total|Total of all reporting groups
139064|NCT01414166|B2|Baseline|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139065|NCT01414166|B1|Baseline|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139066|NCT01414166|P2|Participant Flow|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139067|NCT01414166|P1|Participant Flow|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139068|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139069|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139070|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139071|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139072|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139105|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139073|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139074|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139075|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139076|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139077|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139078|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139079|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139080|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139081|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139082|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139083|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139084|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139085|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139086|NCT01414166|E2|Reported Event|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139087|NCT01414166|E1|Reported Event|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
139088|NCT01414153|B5|Baseline|Total|Total of all reporting groups
139089|NCT01414153|B4|Baseline|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139090|NCT01414153|B3|Baseline|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139091|NCT01414153|B2|Baseline|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139092|NCT01414153|B1|Baseline|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139093|NCT01414153|P4|Participant Flow|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139094|NCT01414153|P3|Participant Flow|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139095|NCT01414153|P2|Participant Flow|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139096|NCT01414153|P1|Participant Flow|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139097|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139098|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139099|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139100|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139101|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139102|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139103|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139104|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
140588|NCT01405950|E2|Reported Event|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
139106|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139107|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139108|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139109|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139110|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139111|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139112|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139113|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139114|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139115|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139116|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139117|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139118|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139119|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139120|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139121|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139122|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139123|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139124|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139125|NCT01414153|E4|Reported Event|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
139126|NCT01414153|E3|Reported Event|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139127|NCT01414153|E2|Reported Event|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
139128|NCT01414153|E1|Reported Event|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
139129|NCT01414036|B3|Baseline|Total|Total of all reporting groups
139130|NCT01414036|B2|Baseline|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139131|NCT01414036|B1|Baseline|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139132|NCT01414036|P2|Participant Flow|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139133|NCT01414036|P1|Participant Flow|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139134|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139135|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139136|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139488|NCT01412424|O1|Outcome|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
139137|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139138|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139139|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139140|NCT01414036|E2|Reported Event|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
139141|NCT01414036|E1|Reported Event|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
139142|NCT01413958|B3|Baseline|Total|Total of all reporting groups
139143|NCT01413958|B2|Baseline|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139144|NCT01413958|B1|Baseline|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139145|NCT01413958|P2|Participant Flow|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139146|NCT01413958|P1|Participant Flow|Phenylephrine|Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
139147|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139148|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139149|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139150|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139151|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139152|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139153|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139154|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139155|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139156|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139157|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139158|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139159|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139160|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139161|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride 30 mg extended release tablets, one dose every 12 hours for 7 days
139162|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139163|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139164|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139165|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139166|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139167|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139168|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139169|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139170|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139171|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139172|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139173|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139174|NCT01413958|E2|Reported Event|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139175|NCT01413958|E1|Reported Event|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
139176|NCT01413750|B5|Baseline|Total|Total of all reporting groups
139177|NCT01413750|B4|Baseline|Phase II (Placebo)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139178|NCT01413750|B3|Baseline|Phase II (Vorinostat)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139179|NCT01413750|B2|Baseline|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139180|NCT01413750|B1|Baseline|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139181|NCT01413750|P4|Participant Flow|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139182|NCT01413750|P3|Participant Flow|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139183|NCT01413750|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139184|NCT01413750|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139185|NCT01413750|O1|Outcome|Phase I|All patients enrolled on the Phase I (safety lead-in) portion of the study.
139186|NCT01413750|O2|Outcome|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139187|NCT01413750|O1|Outcome|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139188|NCT01413750|O2|Outcome|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139189|NCT01413750|O1|Outcome|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139190|NCT01413750|E4|Reported Event|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139191|NCT01413750|E3|Reported Event|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Voninostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139192|NCT01413750|E2|Reported Event|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139193|NCT01413750|E1|Reported Event|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
139194|NCT01413542|B3|Baseline|Total|Total of all reporting groups
139195|NCT01413542|B2|Baseline|Group 2|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
139196|NCT01413542|B1|Baseline|Group 1|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
139197|NCT01413542|P4|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
139198|NCT01413542|P3|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
139199|NCT01413542|P2|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
139200|NCT01413542|P1|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
139201|NCT01413542|O1|Outcome|Group 2|The effect of treatment (placebo vs. DPP4 inhibition) on venous GLP-1 levels during intra-arterial GLP-1 infusion.
139202|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
139203|NCT01413542|O1|Outcome|Group 1|The effect of ACE and/or DPP4 inhibition on change in heart rate in response to substance P (SP) was evaluated.
139204|NCT01413542|O2|Outcome|Group 1 (Females)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
139205|NCT01413542|O1|Outcome|Group 1 (Males)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
139206|NCT01413542|O2|Outcome|Group 2|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
139207|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
139208|NCT01413542|E4|Reported Event|Group 2 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
139209|NCT01413542|E3|Reported Event|Group 2 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
139210|NCT01413542|E2|Reported Event|Group 1 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
139211|NCT01413542|E1|Reported Event|Group 1 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
139212|NCT01413516|B3|Baseline|Total|Total of all reporting groups
139213|NCT01413516|B2|Baseline|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
139214|NCT01413516|B1|Baseline|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
139215|NCT01413516|P2|Participant Flow|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
139216|NCT01413516|P1|Participant Flow|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
139217|NCT01413516|O2|Outcome|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
139218|NCT01413516|O1|Outcome|Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
139219|NCT01413516|E2|Reported Event|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
139220|NCT01413516|E1|Reported Event|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
139221|NCT01413360|B1|Baseline|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
139744|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
139222|NCT01413360|P1|Participant Flow|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
139223|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
139224|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
139225|NCT01413360|E1|Reported Event|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
139226|NCT01413204|B4|Baseline|Total|Total of all reporting groups
139227|NCT01413204|B3|Baseline|Placebo|TA-7284 Placebo, once daily for 24 weeks
139228|NCT01413204|B2|Baseline|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
139229|NCT01413204|B1|Baseline|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
139230|NCT01413204|P3|Participant Flow|Placebo|TA-7284 Placebo, once daily for 24 weeks
139231|NCT01413204|P2|Participant Flow|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
139232|NCT01413204|P1|Participant Flow|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
139233|NCT01413204|O3|Outcome|Placebo|TA-7284 Placebo, once daily for 24 weeks
139234|NCT01413204|O2|Outcome|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
139235|NCT01413204|O1|Outcome|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
139236|NCT01413204|E3|Reported Event|Placebo|TA-7284 Placebo, once daily for 24 weeks
139237|NCT01413204|E2|Reported Event|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
139238|NCT01413204|E1|Reported Event|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
139239|NCT01413191|B1|Baseline|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
139240|NCT01413191|P1|Participant Flow|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
139241|NCT01413191|O1|Outcome|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
139242|NCT01413191|E1|Reported Event|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
139243|NCT01412957|B3|Baseline|Total|Total of all reporting groups
139244|NCT01412957|B2|Baseline|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139245|NCT01412957|B1|Baseline|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139246|NCT01412957|P2|Participant Flow|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139247|NCT01412957|P1|Participant Flow|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139248|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139249|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139250|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139251|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139252|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139253|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139254|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139255|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139256|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139257|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139258|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139259|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139260|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139261|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139262|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139263|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
139264|NCT01412957|E2|Reported Event|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
139265|NCT01412957|E1|Reported Event|Panitumumab Plus BSC|
139266|NCT01412944|B3|Baseline|Total|Total of all reporting groups
139370|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139267|NCT01412944|B2|Baseline|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139268|NCT01412944|B1|Baseline|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139269|NCT01412944|P6|Participant Flow|AIN457 300 mg - AIN457 10 mg/kg I.V.|
139270|NCT01412944|P5|Participant Flow|AIN457 150 mg - AIN457 10 mg/kg I.V.|
139271|NCT01412944|P4|Participant Flow|AIN457 300 mg - AIN457 300 mg s.c.|
139272|NCT01412944|P3|Participant Flow|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
139273|NCT01412944|P2|Participant Flow|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139274|NCT01412944|P1|Participant Flow|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139275|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139276|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139277|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139278|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139279|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139280|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139281|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139282|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139283|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139284|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139285|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139286|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139287|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139288|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139289|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139290|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139291|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139292|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139487|NCT01412424|O2|Outcome|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
139293|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139294|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
139295|NCT01412944|E12|Reported Event|Follow-up: AIN457 150 mg - 10 mg/kg i.v.|
139296|NCT01412944|E11|Reported Event|Follow-up: AIN457 150 mg - 300 mg s.c.|
139297|NCT01412944|E10|Reported Event|Follow-up: AIN457 300 mg - 10 mg/kg i.v.|
139298|NCT01412944|E9|Reported Event|Follow up: AIN457 300 mg - AIN457 300 mg s.c.|
139299|NCT01412944|E8|Reported Event|Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
139300|NCT01412944|E7|Reported Event|Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
139301|NCT01412944|E6|Reported Event|Entire Period: AIN457 300 mg - AIN457 300 mg s.c.|
139302|NCT01412944|E5|Reported Event|Entire Period: AIN457 150 mg - AIN457 300 mg s.c.|
139303|NCT01412944|E4|Reported Event|I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
139304|NCT01412944|E3|Reported Event|I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
139305|NCT01412944|E2|Reported Event|I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.|
139306|NCT01412944|E1|Reported Event|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
139307|NCT01412918|B3|Baseline|Total|Total of all reporting groups
139308|NCT01412918|B2|Baseline|No Tinnitus|Individuals without tinnitus.
139309|NCT01412918|B1|Baseline|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
139310|NCT01412918|P2|Participant Flow|No Tinnitus|Individuals without tinnitus.
139311|NCT01412918|P1|Participant Flow|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
139312|NCT01412918|O2|Outcome|No Tinnitus|Individuals without tinnitus.
139313|NCT01412918|O1|Outcome|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
139314|NCT01412918|O1|Outcome|Tinnitus|Tinnitus. genetic sample collection (no intervention)
139315|NCT01412918|E2|Reported Event|No Tinnitus|Individuals without tinnitus.
139316|NCT01412918|E1|Reported Event|Tinnitus|"Individual with tinnitus. Intervention: inhibitor device demonstration.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
139317|NCT01412801|B7|Baseline|Total|Total of all reporting groups
139318|NCT01412801|B6|Baseline|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
139319|NCT01412801|B5|Baseline|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
139320|NCT01412801|B4|Baseline|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
139321|NCT01412801|B3|Baseline|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139322|NCT01412801|B2|Baseline|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139323|NCT01412801|B1|Baseline|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139324|NCT01412801|P6|Participant Flow|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
139325|NCT01412801|P5|Participant Flow|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
139326|NCT01412801|P4|Participant Flow|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
139327|NCT01412801|P3|Participant Flow|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139328|NCT01412801|P2|Participant Flow|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139329|NCT01412801|P1|Participant Flow|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139330|NCT01412801|O3|Outcome|HIVneg|"Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.~Infants: Infants born to HIV-antibody negative maternal subjects"
139331|NCT01412801|O2|Outcome|HIVposCD4HIGH|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
139332|NCT01412801|O1|Outcome|HIVposCD4LOW|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
139333|NCT01412801|O3|Outcome|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
139334|NCT01412801|O2|Outcome|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
139335|NCT01412801|O1|Outcome|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
139336|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139337|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139338|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139339|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139340|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139341|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139342|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139343|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139344|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139345|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
139346|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139347|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139348|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139349|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139350|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139351|NCT01412801|O6|Outcome|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
139352|NCT01412801|O5|Outcome|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
139353|NCT01412801|O4|Outcome|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
139354|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139355|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139356|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
139357|NCT01412801|E8|Reported Event|Total Maternal Subjects|Total number of Maternal subjects participated in the study
139358|NCT01412801|E7|Reported Event|HIVneg_Maternal Subjects|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
139359|NCT01412801|E6|Reported Event|HIVposCD4HIGH_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
139360|NCT01412801|E5|Reported Event|HIVposCD4LOW_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
139361|NCT01412801|E4|Reported Event|Total (Infants)|Total number of Infants participated in the study
139362|NCT01412801|E3|Reported Event|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
139363|NCT01412801|E2|Reported Event|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
139364|NCT01412801|E1|Reported Event|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
139365|NCT01412541|B3|Baseline|Total|Total of all reporting groups
139366|NCT01412541|B2|Baseline|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139367|NCT01412541|B1|Baseline|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139368|NCT01412541|P2|Participant Flow|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139369|NCT01412541|P1|Participant Flow|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139371|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139372|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139373|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139374|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139375|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139376|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139377|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139378|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139379|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139380|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139381|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139382|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139383|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139384|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139385|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139386|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139387|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139388|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139389|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139390|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139391|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139392|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139393|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139394|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139395|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139396|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139397|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139398|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139399|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139400|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
155085|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
139401|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139402|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139403|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139404|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139405|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139406|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139407|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139408|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139409|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139410|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139411|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139412|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139413|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139414|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139415|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139416|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139417|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139418|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139419|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139420|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139421|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139422|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139423|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139424|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139425|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139426|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139427|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139428|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139429|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139430|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139745|NCT01410565|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
139431|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139432|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139433|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139434|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139435|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139436|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139437|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139438|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139439|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139440|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139441|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139442|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139443|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139444|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139445|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139446|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139447|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139448|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139449|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139450|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139451|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139452|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139453|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139454|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139455|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139456|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139457|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139458|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139459|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139460|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
155086|NCT01344460|O2|Outcome|Unenhanced MRA|
139461|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139462|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139463|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139464|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139465|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139466|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139467|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139468|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139469|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139470|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139471|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139472|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139473|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139474|NCT01412541|E2|Reported Event|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139475|NCT01412541|E1|Reported Event|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
139476|NCT01412424|B1|Baseline|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139477|NCT01412424|P1|Participant Flow|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139478|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139479|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139480|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139481|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139482|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139483|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139484|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
139485|NCT01412424|O4|Outcome|Octreotide 40, 60, or 80 mg - All Participants|Participants received octreotide 40, 60, or 80 mg orally for up to 13 months.
139486|NCT01412424|O3|Outcome|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
139489|NCT01412424|E3|Reported Event|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
139490|NCT01412424|E2|Reported Event|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
139491|NCT01412424|E1|Reported Event|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
139492|NCT01412281|B5|Baseline|Total|Total of all reporting groups
139493|NCT01412281|B4|Baseline|>60 Years - CSL HA Antigen|
139494|NCT01412281|B3|Baseline|>60 Years - AdImmune HA Antigen|
139495|NCT01412281|B2|Baseline|≥18 to ≤60 Years - CSL HA Antigen|
139496|NCT01412281|B1|Baseline|≥18 to ≤60 Years - AdImmune HA Antigen|
139497|NCT01412281|P4|Participant Flow|>60 Years - CSL HA Antigen|
139498|NCT01412281|P3|Participant Flow|>60 Years - AdImmune HA Antigen|
139499|NCT01412281|P2|Participant Flow|≥18 to ≤60 Years - CSL HA Antigen|
139500|NCT01412281|P1|Participant Flow|≥18 to ≤60 Years - AdImmune HA Antigen|
139501|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
139502|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
139503|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
139504|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
139505|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
139506|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
139507|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
139508|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
139509|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
139510|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
139511|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
139512|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
139513|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
139514|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
139515|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
139516|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
139517|NCT01412281|E4|Reported Event|>60 Years - CSL HA Antigen|
139518|NCT01412281|E3|Reported Event|>60 Years - AdImmune HA Antigen|
139519|NCT01412281|E2|Reported Event|≥18 to ≤60 Years - CSL HA Antigen|
139520|NCT01412281|E1|Reported Event|≥18 to ≤60 Years - AdImmune HA Antigen|
139521|NCT01412164|B1|Baseline|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
139522|NCT01412164|P1|Participant Flow|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
139523|NCT01412164|O1|Outcome|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
139524|NCT01412164|E1|Reported Event|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
139525|NCT01412151|B1|Baseline|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
139526|NCT01412151|P1|Participant Flow|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
139527|NCT01412151|O1|Outcome|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
139528|NCT01412151|E1|Reported Event|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
139529|NCT01412086|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was received.
139530|NCT01412086|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was received.
139531|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
139532|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
139533|NCT01412086|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was received.
139534|NCT01411891|B3|Baseline|Total|Total of all reporting groups
139535|NCT01411891|B2|Baseline|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139536|NCT01411891|B1|Baseline|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139537|NCT01411891|P2|Participant Flow|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139538|NCT01411891|P1|Participant Flow|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139539|NCT01411891|O2|Outcome|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139540|NCT01411891|O1|Outcome|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139541|NCT01411891|E2|Reported Event|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139542|NCT01411891|E1|Reported Event|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
139543|NCT01411852|B3|Baseline|Total|Total of all reporting groups
140589|NCT01405950|E1|Reported Event|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
139544|NCT01411852|B2|Baseline|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139545|NCT01411852|B1|Baseline|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139546|NCT01411852|P2|Participant Flow|0.9% Sodium Chloride 250 mL Bolus|"0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.~0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first."
139547|NCT01411852|P1|Participant Flow|0.9% Sodium Chloride 2000 mL Bolus|"0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.~0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg."
139548|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139549|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139550|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139551|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139552|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139553|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139554|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139555|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139556|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139557|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139558|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139559|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139560|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139561|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139562|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139563|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139564|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139565|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139566|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139567|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139568|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139569|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139570|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139571|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139572|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139573|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139574|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139575|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139576|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139577|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139578|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139579|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139580|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139581|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139582|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139583|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139584|NCT01411852|O3|Outcome|ECV Difference [Standard - Controlled]|ECV treatment difference between SR and CR
139585|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
139586|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139587|NCT01411852|E2|Reported Event|Controlled Resuscitation (CR)|"Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.~The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment."
139588|NCT01411852|E1|Reported Event|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
139589|NCT01411696|B1|Baseline|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139590|NCT01411696|P1|Participant Flow|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139591|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139592|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139593|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139594|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139595|NCT01411696|E1|Reported Event|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
139596|NCT01411592|B3|Baseline|Total|Total of all reporting groups
139597|NCT01411592|B2|Baseline|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
140590|NCT01405937|B3|Baseline|Total|Total of all reporting groups
139598|NCT01411592|B1|Baseline|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
139599|NCT01411592|P2|Participant Flow|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
139600|NCT01411592|P1|Participant Flow|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
139601|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
139602|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
139603|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
139604|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
139605|NCT01411592|E2|Reported Event|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
139606|NCT01411592|E1|Reported Event|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
139607|NCT01411501|B5|Baseline|Total|Total of all reporting groups
139608|NCT01411501|B4|Baseline|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139609|NCT01411501|B3|Baseline|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139610|NCT01411501|B2|Baseline|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139685|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139686|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139611|NCT01411501|B1|Baseline|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139612|NCT01411501|P4|Participant Flow|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139613|NCT01411501|P3|Participant Flow|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139614|NCT01411501|P2|Participant Flow|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139615|NCT01411501|P1|Participant Flow|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139616|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139617|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139618|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139619|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139620|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139621|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139687|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
140896|NCT01404611|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
139622|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139623|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139624|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139625|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139626|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139627|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139628|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139629|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139630|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139631|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139632|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139688|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139689|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139633|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139634|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139635|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139636|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139637|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139638|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139639|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139640|NCT01411501|E4|Reported Event|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
139641|NCT01411501|E3|Reported Event|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139642|NCT01411501|E2|Reported Event|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139690|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139691|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139746|NCT01410565|E1|Reported Event|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
139643|NCT01411501|E1|Reported Event|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
139644|NCT01411228|B4|Baseline|Total|Total of all reporting groups
139645|NCT01411228|B3|Baseline|Dose Adjusted|Taliglucerase alfa: Dose increased from 30 Units/kg to 45 or 60 Units/kg
139646|NCT01411228|B2|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139647|NCT01411228|B1|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139648|NCT01411228|P3|Participant Flow|Switchover|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139649|NCT01411228|P2|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139650|NCT01411228|P1|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139651|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139652|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139653|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139654|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139655|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139656|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139657|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139658|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139659|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139660|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139661|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139662|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139663|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139664|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139665|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139666|NCT01411228|E3|Reported Event|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
139667|NCT01411228|E2|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139668|NCT01411228|E1|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
139669|NCT01411215|B3|Baseline|Total|Total of all reporting groups
139670|NCT01411215|B2|Baseline|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139671|NCT01411215|B1|Baseline|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139672|NCT01411215|P2|Participant Flow|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139673|NCT01411215|P1|Participant Flow|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139674|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139675|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139676|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139677|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139678|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139679|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139680|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139681|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139682|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139683|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139684|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139692|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139693|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139694|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139695|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139696|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139697|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139698|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139699|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139700|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139701|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139702|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139703|NCT01411215|E2|Reported Event|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139704|NCT01411215|E1|Reported Event|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
139705|NCT01410773|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
139706|NCT01410773|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
139707|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
139708|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
139709|NCT01410773|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
139710|NCT01410604|B3|Baseline|Total|Total of all reporting groups
139711|NCT01410604|B2|Baseline|Placebo|
139712|NCT01410604|B1|Baseline|Metformin|
139713|NCT01410604|P2|Participant Flow|Placebo|
139714|NCT01410604|P1|Participant Flow|Metformin|
139715|NCT01410604|O2|Outcome|Placebo|
139716|NCT01410604|O1|Outcome|Metformin|
139717|NCT01410604|O2|Outcome|Placebo|
139718|NCT01410604|O1|Outcome|Metformin|
139719|NCT01410604|O2|Outcome|Placebo|
139720|NCT01410604|O1|Outcome|Metformin|
139721|NCT01410604|O2|Outcome|Placebo|
139722|NCT01410604|O1|Outcome|Metformin|
139723|NCT01410604|O2|Outcome|Placebo|
139724|NCT01410604|O1|Outcome|Metformin|
139725|NCT01410604|O2|Outcome|Placebo|
139726|NCT01410604|O1|Outcome|Metformin|
139727|NCT01410604|O2|Outcome|Placebo|
139728|NCT01410604|O1|Outcome|Metformin|
139729|NCT01410604|O2|Outcome|Placebo|
139730|NCT01410604|O1|Outcome|Metformin|
139731|NCT01410604|E2|Reported Event|Placebo|
139732|NCT01410604|E1|Reported Event|Metformin|
139733|NCT01410565|B3|Baseline|Total|Total of all reporting groups
139734|NCT01410565|B2|Baseline|Placebo|"Placebo~Placebo in the Double Blind Phase"
139735|NCT01410565|B1|Baseline|Apaziquone|"Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
139736|NCT01410565|P3|Participant Flow|Open Label-Apaziquone|
139737|NCT01410565|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
139738|NCT01410565|P1|Participant Flow|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
139739|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
139740|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
139741|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
139742|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
139748|NCT01410474|B2|Baseline|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139749|NCT01410474|B1|Baseline|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139750|NCT01410474|P2|Participant Flow|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139751|NCT01410474|P1|Participant Flow|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139752|NCT01410474|O3|Outcome|Overall (6-18 Years)|Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
139753|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
139754|NCT01410474|O1|Outcome|6-10 Years|Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
139755|NCT01410474|O1|Outcome|2-5 Years|Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
139756|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139757|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139758|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139759|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139760|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139761|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139762|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139763|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139764|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139765|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139766|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139767|NCT01410474|O1|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139768|NCT01410474|E3|Reported Event|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139769|NCT01410474|E2|Reported Event|11–18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139770|NCT01410474|E1|Reported Event|2–10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
139771|NCT01410409|B3|Baseline|Total|Total of all reporting groups
139772|NCT01410409|B2|Baseline|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139773|NCT01410409|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139774|NCT01410409|P2|Participant Flow|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139807|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139808|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139809|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139775|NCT01410409|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139776|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139777|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139778|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139779|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139780|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139781|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139782|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139810|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139811|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
140897|NCT01404611|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
139783|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139784|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139785|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139786|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139787|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139788|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139789|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139790|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139812|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139813|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
140898|NCT01404611|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
139791|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139792|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139793|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139794|NCT01410409|E2|Reported Event|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139795|NCT01410409|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
139796|NCT01410240|B4|Baseline|Total|Total of all reporting groups
139797|NCT01410240|B3|Baseline|FLOSEAL + Standard of Care (SoC) - Run-In|"Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
139798|NCT01410240|B2|Baseline|FLOSEAL + Standard of Care (SoC) - Non-Run-In|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
139799|NCT01410240|B1|Baseline|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139800|NCT01410240|P3|Participant Flow|FLOSEAL + Standard of Care (SoC) Run-In Participants|"This arm/group only includes the 12 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139801|NCT01410240|P2|Participant Flow|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139802|NCT01410240|P1|Participant Flow|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139803|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139804|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139805|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139806|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
140899|NCT01404611|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
139814|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139815|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139816|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139817|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139818|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139819|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139820|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
139821|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139822|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
139823|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139824|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
139825|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139826|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139827|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139828|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139829|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139830|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139831|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139832|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139833|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139834|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139835|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139836|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139837|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139838|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139839|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139840|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139841|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139842|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139843|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139844|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139845|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139846|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139847|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139848|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139849|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139850|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139851|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139852|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139853|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139854|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139855|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139856|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139857|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139858|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139859|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139860|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139861|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139862|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139863|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139864|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139865|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139866|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139867|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139868|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139869|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139870|NCT01410240|E2|Reported Event|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
139871|NCT01410240|E1|Reported Event|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
139872|NCT01410227|B1|Baseline|All Subjects Treated With Study Product|All subjects treated with study product
139968|NCT01410110|E2|Reported Event|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139873|NCT01410227|P4|Participant Flow|Arm 4: Treatment Only|In Part A, participants received on-demand treatment for bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] administered together with recombinant Factor VIII [rFVIII] (rVWF:rFVIII) or rVWF alone), where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels. If not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months. No pharmacokinetic (PK) assessments were conducted in this arm.
139874|NCT01410227|P3|Participant Flow|Arm 3: PK80 + Treatment|In Part A, participants initially underwent a first PK assessment of an infusion of 80 IU/kg recombinant von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF]. After the first PK assessment participants received on demand treatment for bleeding episodes (BEs) with study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rWVF with or without rFVIII, based on FVIII levels. If FVIII levels not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. After 6 months participants underwent a second PK assessment of an infusion of 80 IU/kg rVWF. In part B, participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
139875|NCT01410227|P2|Participant Flow|Arm 2: PK50 Only|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). Participants then exited the study or could opt to sign informed consent to move to Arm 1 receive treatment for bleeding episodes with study product.
139876|NCT01410227|P1|Participant Flow|Arm 1: PK50 + Treatment|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
139877|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139878|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139879|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139880|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139881|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139882|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139883|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139884|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139885|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139886|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139940|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
139887|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139888|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139889|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139890|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139891|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139892|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139893|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139894|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139895|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139896|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139897|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139898|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139899|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139900|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
139901|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139902|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139903|NCT01410227|O1|Outcome|Overall Study Arm|
139904|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139905|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139941|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
139906|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139907|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139908|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139909|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139910|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139911|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139912|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139913|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139914|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139915|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139916|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139917|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139918|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139919|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
140900|NCT01404611|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
139920|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139921|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139922|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139923|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139924|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139925|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139926|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139927|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139928|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total of participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
139929|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139930|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139931|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139932|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139933|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139934|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139935|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139936|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139937|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139938|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139939|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
139942|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
139943|NCT01410227|O1|Outcome|Full Analysis Set|Comprises of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
139944|NCT01410227|E1|Reported Event|Safety Analysis Set|Comprises of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
139945|NCT01410110|B3|Baseline|Total|Total of all reporting groups
139946|NCT01410110|B2|Baseline|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139947|NCT01410110|B1|Baseline|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139948|NCT01410110|P2|Participant Flow|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139949|NCT01410110|P1|Participant Flow|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139950|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139951|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139952|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139953|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139954|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139955|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139956|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139957|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139958|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139959|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139960|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139961|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139962|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139963|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139964|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139965|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139966|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
139967|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
140019|NCT01408537|O8|Outcome|SAEs Entire the Study|SAEs which occured entire the study period were recorded.
139969|NCT01410110|E1|Reported Event|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
139970|NCT01409837|B3|Baseline|Total|Total of all reporting groups
139971|NCT01409837|B2|Baseline|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139972|NCT01409837|B1|Baseline|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139973|NCT01409837|P2|Participant Flow|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.
139974|NCT01409837|P1|Participant Flow|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
139975|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139976|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139977|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139978|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139979|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139980|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139981|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139982|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139983|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139984|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139985|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
139986|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
139987|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
139988|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
139989|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139990|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139991|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
139992|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
139993|NCT01409837|E2|Reported Event|Events Reported During Treatment With Placebo|All the events reported by patients in either group A or group B while receiving the Sugar Pill.
139994|NCT01409837|E1|Reported Event|Events Reported During Treatment With Lisinopril|All the events reported by patients in either group A or group B while receiving Lisinopril.
139995|NCT01409707|B4|Baseline|Total|Total of all reporting groups
139996|NCT01409707|B3|Baseline|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
139997|NCT01409707|B2|Baseline|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
139998|NCT01409707|B1|Baseline|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
139999|NCT01409707|P3|Participant Flow|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
140000|NCT01409707|P2|Participant Flow|Trauma-focused Exposure Therapy|Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140001|NCT01409707|P1|Participant Flow|Healthy Lifestyles Sessions|Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
140901|NCT01404611|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
140002|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140003|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140004|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
140005|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140006|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140007|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
140008|NCT01409707|E2|Reported Event|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
140009|NCT01409707|E1|Reported Event|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
140010|NCT01408628|B1|Baseline|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
140011|NCT01408628|P1|Participant Flow|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
140012|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
140013|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
140014|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm.
140015|NCT01408628|E1|Reported Event|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
140016|NCT01408537|B1|Baseline|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
140017|NCT01408537|P1|Participant Flow|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
140018|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
155087|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
140020|NCT01408537|O7|Outcome|Unsolicited AEs After Each Vaccination|unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
140021|NCT01408537|O6|Outcome|Urticaria After Vaccination|Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
140022|NCT01408537|O5|Outcome|Vomiting After Vaccination|Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
140023|NCT01408537|O4|Outcome|Poor Appetite After Vaccination|Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
140024|NCT01408537|O3|Outcome|Chills After Vaccination|Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
140025|NCT01408537|O2|Outcome|Local AE JEVAC After Vaccination|"Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))~, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination."
140026|NCT01408537|O1|Outcome|Fever After Vaccination|Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.
140027|NCT01408537|O3|Outcome|GMT of NT Titer After Booster Vaccine|GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
140028|NCT01408537|O2|Outcome|GMT of NT Before Booster Vaccine|GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
140029|NCT01408537|O1|Outcome|GMT of NT on 28days After Vaccination|GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
140030|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
140031|NCT01408537|E1|Reported Event|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
140032|NCT01408485|B1|Baseline|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140033|NCT01408485|P1|Participant Flow|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140034|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140035|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140036|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140037|NCT01408485|E1|Reported Event|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
140038|NCT01409564|B3|Baseline|Total|Total of all reporting groups
140039|NCT01409564|B2|Baseline|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140040|NCT01409564|B1|Baseline|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140041|NCT01409564|P2|Participant Flow|Placebo|Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.
140042|NCT01409564|P1|Participant Flow|Cilostazol|Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
140043|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140044|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140045|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140046|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140047|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140048|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140049|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140050|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140051|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140052|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140053|NCT01409564|O4|Outcome|Placebo, 24-week|Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks.
141237|NCT01402102|B2|Baseline|Placebo|Oral intake placebo(6.0g/day) for 12weeks
140054|NCT01409564|O3|Outcome|Placebo, Baseline|Placebo group means dementia patients group receiving donepezil with placebo at the baseline.
140055|NCT01409564|O2|Outcome|Cilostazol, 24-week|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks.
140056|NCT01409564|O1|Outcome|Cilostazol, Baseline|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation at the baseline.
140057|NCT01409564|E2|Reported Event|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
140058|NCT01409564|E1|Reported Event|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
140059|NCT01409434|B1|Baseline|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140060|NCT01409434|P1|Participant Flow|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140061|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140062|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140063|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140064|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140065|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140066|NCT01409434|E1|Reported Event|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
140067|NCT01409382|B3|Baseline|Total|Total of all reporting groups
140068|NCT01409382|B2|Baseline|Standard Follow-up|Prenatal care will proceed according to the routine
140069|NCT01409382|B1|Baseline|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
140070|NCT01409382|P2|Participant Flow|Standard Follow-up|Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
140071|NCT01409382|P1|Participant Flow|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
140072|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
140073|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
140074|NCT01409382|O2|Outcome|Neonates Born to Controls|Neonates with hypoglycemia detected 1, 2 or 4 hours after birth
140075|NCT01409382|O1|Outcome|Neonates Born to Mothers Assigned to Protocol Walking+Diet|Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth
140076|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
140077|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
140078|NCT01409382|E4|Reported Event|Lifestyle Counseling (Babies)|Exercise plus a carbohydrate-controlled diet.
140079|NCT01409382|E3|Reported Event|Standard Follow-up (Babies)|Prenatal care will proceed according to the routine.
140080|NCT01409382|E2|Reported Event|Lifestyle Counseling (Mothers)|Exercise plus a carbohydrate-controlled diet.
140081|NCT01409382|E1|Reported Event|Standard Follow-up (Mothers)|Prenatal care will proceed according to the routine.
140082|NCT01409291|B3|Baseline|Total|Total of all reporting groups
140083|NCT01409291|B2|Baseline|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
140084|NCT01409291|B1|Baseline|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
140085|NCT01409291|P2|Participant Flow|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
140086|NCT01409291|P1|Participant Flow|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
140087|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
140088|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
140089|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
140090|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
140091|NCT01409291|E2|Reported Event|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
140092|NCT01409291|E1|Reported Event|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
140093|NCT01409239|B3|Baseline|Total|Total of all reporting groups
140094|NCT01409239|B2|Baseline|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
140095|NCT01409239|B1|Baseline|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
140096|NCT01409239|P2|Participant Flow|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
140097|NCT01409239|P1|Participant Flow|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
140098|NCT01409239|O2|Outcome|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
140099|NCT01409239|O1|Outcome|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
140100|NCT01409239|E2|Reported Event|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
140101|NCT01409239|E1|Reported Event|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
140102|NCT01409213|B1|Baseline|All Enrolled Participants|Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
140103|NCT01409213|P1|Participant Flow|All Enrolled Participants|
140104|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
140105|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
140106|NCT01409213|E1|Reported Event|All Enrolled Participants|
140107|NCT01409096|B3|Baseline|Total|Total of all reporting groups
140108|NCT01409096|B2|Baseline|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140109|NCT01409096|B1|Baseline|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140110|NCT01409096|P2|Participant Flow|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140111|NCT01409096|P1|Participant Flow|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140112|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140113|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140114|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140203|NCT01408719|P1|Participant Flow|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
141238|NCT01402102|B1|Baseline|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
140115|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140116|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140117|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140118|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140119|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140120|NCT01409096|E2|Reported Event|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
140121|NCT01409096|E1|Reported Event|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
140122|NCT01408992|B1|Baseline|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older
140123|NCT01408992|P1|Participant Flow|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded.
140124|NCT01408992|O1|Outcome|Hearing Loss|The severity of hearing loss was defined by the pure tone average air-conduction threshold at the speech frequencies of the better hearing ears, according to the ASHA criteria. Normal hearing means PTA of less than or equal 25 dB. Mild hearing loss means PTA of 26-40 dB. Moderate hearing loss means PTA of 41-55 dB. Moderately severe hearing loss means PTA of 56-74 dB. Severe hearing loss means PTA of 75-90 dB. Profound hearing loss means PTA > 90 dB.
140125|NCT01408992|O1|Outcome|FMHT|"FMHT Score is the sum of value of the answers for each question. If the subject answers never, it will be scored as 0, occasionally will be 1, half the time will be 2, and almost always will be 3."
140126|NCT01408992|O7|Outcome|Mixed Hearing Loss|Air and bone conduction threshold are more than 25 dB with air-bone gap
140127|NCT01408992|O6|Outcome|Sensorineural Hearing Loss|Air and bone conduction thresholds are more than 25 dB
140128|NCT01408992|O5|Outcome|Conductive Hearing Loss|Air-bone gap and bone conduction thresholds are lower than 25 dB
140129|NCT01408992|O4|Outcome|Chronic Otitis Media|Tympanic membrane perforation with or without ear discharge
140130|NCT01408992|O3|Outcome|Otitis Media With Effusion|Fluid in middle ear, whether serous, mucoid, mucous, or pus
140131|NCT01408992|O2|Outcome|Ear Wax|Impacted cerumen
140132|NCT01408992|O1|Outcome|Normal Ears and Hearing|Normal ear examination and normal hearing
140133|NCT01408992|E1|Reported Event|Community People|All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand.
140134|NCT01408888|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
140135|NCT01408888|P2|Participant Flow|Sitagliptin + LY2189265, LY2189265|"First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).~There was a washout of at least 21 days between treatments."
140136|NCT01408888|P1|Participant Flow|LY2189265, Sitagliptin + LY2189265|"First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).~Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~There was a washout of at least 21 days between treatments."
140137|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
140204|NCT01408719|O4|Outcome|Control|"control diet containing negligible amount of beta glucan~3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan"
140138|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
140139|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
140140|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
140141|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
140142|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
140143|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
140144|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
140145|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
140146|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
140147|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
140148|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
140149|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
140150|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
140151|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
140152|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
140153|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
140154|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
140205|NCT01408719|O3|Outcome|3g LMW Beta Glucan|"3 grams of low molecular weight beta-glucan diet for 35 days~5g LMW beta-glucan: 5 grams beta-glucan"
140206|NCT01408719|O2|Outcome|3g HMW Beta Glucan|"3 gram high molecular weight barley beta-glucan diet for 35 days~3g LMW beta-glucan: 3grams beta-glucan"
140155|NCT01408888|E3|Reported Event|Sitagliptin + LY2189265|"Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.~Time Frame: Day 5 to end of Treatment 2"
140156|NCT01408888|E2|Reported Event|Sitagliptin|"Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.~Time Frame: Day 1 to Day 5 of Treatment 2"
140157|NCT01408888|E1|Reported Event|LY2189265|"LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1~Time frame: Treatment 1"
140158|NCT01408862|B1|Baseline|Controls|Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
140159|NCT01408862|P1|Participant Flow|Controls|"20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
140160|NCT01408862|O1|Outcome|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
140161|NCT01408862|O1|Outcome|Controls|Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
140162|NCT01408862|E1|Reported Event|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
140163|NCT01408719|B21|Baseline|Total|Total of all reporting groups
140164|NCT01408719|B20|Baseline|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
140165|NCT01408719|B19|Baseline|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
140166|NCT01408719|B18|Baseline|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
140167|NCT01408719|B17|Baseline|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
140168|NCT01408719|B16|Baseline|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
140169|NCT01408719|B15|Baseline|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
140170|NCT01408719|B14|Baseline|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
140171|NCT01408719|B13|Baseline|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
140172|NCT01408719|B12|Baseline|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
140173|NCT01408719|B11|Baseline|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
140174|NCT01408719|B10|Baseline|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
140175|NCT01408719|B9|Baseline|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
140176|NCT01408719|B8|Baseline|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
140177|NCT01408719|B7|Baseline|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
140178|NCT01408719|B6|Baseline|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
140179|NCT01408719|B5|Baseline|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
140180|NCT01408719|B4|Baseline|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
140181|NCT01408719|B3|Baseline|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
140182|NCT01408719|B2|Baseline|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
140183|NCT01408719|B1|Baseline|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
140184|NCT01408719|P20|Participant Flow|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
140185|NCT01408719|P19|Participant Flow|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
140186|NCT01408719|P18|Participant Flow|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
140187|NCT01408719|P17|Participant Flow|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
140188|NCT01408719|P16|Participant Flow|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
140189|NCT01408719|P15|Participant Flow|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
140190|NCT01408719|P14|Participant Flow|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
140191|NCT01408719|P13|Participant Flow|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
140192|NCT01408719|P12|Participant Flow|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
140193|NCT01408719|P11|Participant Flow|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
140194|NCT01408719|P10|Participant Flow|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
140195|NCT01408719|P9|Participant Flow|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
140196|NCT01408719|P8|Participant Flow|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
140197|NCT01408719|P7|Participant Flow|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
140198|NCT01408719|P6|Participant Flow|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
140199|NCT01408719|P5|Participant Flow|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
140200|NCT01408719|P4|Participant Flow|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
140201|NCT01408719|P3|Participant Flow|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
140202|NCT01408719|P2|Participant Flow|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
140520|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140207|NCT01408719|O1|Outcome|5g LMW Beta Glucan|"5 gram low molecular weight barley beta-glucan diet for 35 days~Control: Minimal beta-glucan"
140208|NCT01408719|E4|Reported Event|5g LMW Beta-glucan|5 grams low molecular weight barley beta-glucan
140209|NCT01408719|E3|Reported Event|3g LMW Beta-glucan|3 grams low molecular weight barley beta-glucan
140210|NCT01408719|E2|Reported Event|3g HMW Beta-glucan|3 grams high molecular weight barley beta-glucan
140211|NCT01408719|E1|Reported Event|Control|Minimal barley and minimal beta-glucan
140212|NCT01408329|B3|Baseline|Total|Total of all reporting groups
140213|NCT01408329|B2|Baseline|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
140214|NCT01408329|B1|Baseline|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
140215|NCT01408329|P2|Participant Flow|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
140216|NCT01408329|P1|Participant Flow|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
140217|NCT01408329|O2|Outcome|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6097m
140218|NCT01408329|O1|Outcome|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
140219|NCT01408329|E2|Reported Event|Cyclic Hypoxic Group|Rapidly fluctuating simulated altitude up to 6097 meters
140220|NCT01408329|E1|Reported Event|Sham Group|Slowly fluctuating simulated altitude up to 607 meters.
140221|NCT01408303|B4|Baseline|Total|Total of all reporting groups
140222|NCT01408303|B3|Baseline|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
140223|NCT01408303|B2|Baseline|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
140224|NCT01408303|B1|Baseline|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
140225|NCT01408303|P3|Participant Flow|Olive Oil + Statin|"olive oil, 1 g capsule~olive oil: 4 x 1 g capsule daily for 6 weeks~prescribed statin"
140226|NCT01408303|P2|Participant Flow|Epanova, 4 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks~prescribed statin"
140227|NCT01408303|P1|Participant Flow|Epanova, 2 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks~prescribe statin"
140228|NCT01408303|O3|Outcome|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
140229|NCT01408303|O2|Outcome|Epanova 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
140230|NCT01408303|O1|Outcome|Epanova 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
140231|NCT01408303|E3|Reported Event|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
140232|NCT01408303|E2|Reported Event|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
140233|NCT01408303|E1|Reported Event|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
140234|NCT01408277|B3|Baseline|Total|Total of all reporting groups
140235|NCT01408277|B2|Baseline|Control|Standard Care
140236|NCT01408277|B1|Baseline|Santyl|Collagenase (SANTYL®) Ointment
140237|NCT01408277|P2|Participant Flow|Control|Standard Care
140238|NCT01408277|P1|Participant Flow|Santyl|Collagenase (SANTYL®) Ointment
140239|NCT01408277|O2|Outcome|Control|"Control = Standard Care~Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.)."
140240|NCT01408277|O1|Outcome|Santyl®|Collagenase (Santyl®) Ointment
140241|NCT01408277|E2|Reported Event|Control|Standard Care
140242|NCT01408277|E1|Reported Event|Santyl|Collagense (Santyl®) Ointment
140243|NCT01407575|B3|Baseline|Total|Total of all reporting groups
140244|NCT01407575|B2|Baseline|Placebo|Placebo: matched placebo
140245|NCT01407575|B1|Baseline|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140246|NCT01407575|P2|Participant Flow|Placebo|Placebo: matched placebo
140247|NCT01407575|P1|Participant Flow|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140248|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140249|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140250|NCT01407575|O2|Outcome|Placebo|"matching placebo- sublingual- over the course of 8 weeks~Placebo: matched placebo"
140251|NCT01407575|O1|Outcome|Buprenorphine|"0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)"
140252|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140253|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140254|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140255|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140256|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140257|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140258|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140259|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140260|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
140261|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140262|NCT01407575|E2|Reported Event|Placebo|Placebo: matched placebo
140263|NCT01407575|E1|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
140577|NCT01405950|P3|Participant Flow|Dose Level 3|Zanaflex Capsules : 0.075 mg/kg
140264|NCT01407523|B1|Baseline|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140265|NCT01407523|P1|Participant Flow|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140266|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140267|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140268|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140269|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140270|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140271|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140272|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140273|NCT01407523|E1|Reported Event|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
140274|NCT01407354|B1|Baseline|All Study Participants|Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
140275|NCT01407354|P2|Participant Flow|Aquatic Therapy First Then Lokomat Intervention|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise"
140276|NCT01407354|P1|Participant Flow|Lokomat First Then Aquatic Exercise|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat"
140277|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
140278|NCT01407354|O1|Outcome|Lokomat|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session,"
140279|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
140280|NCT01407354|O1|Outcome|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
140281|NCT01407354|E2|Reported Event|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
140282|NCT01407354|E1|Reported Event|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
140283|NCT01407276|B9|Baseline|Total|Total of all reporting groups
140284|NCT01407276|B8|Baseline|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
140285|NCT01407276|B7|Baseline|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
140286|NCT01407276|B6|Baseline|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140287|NCT01407276|B5|Baseline|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140288|NCT01407276|B4|Baseline|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140289|NCT01407276|B3|Baseline|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140578|NCT01405950|P2|Participant Flow|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
140290|NCT01407276|B2|Baseline|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140291|NCT01407276|B1|Baseline|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140292|NCT01407276|P8|Participant Flow|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
140293|NCT01407276|P7|Participant Flow|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
140294|NCT01407276|P6|Participant Flow|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140295|NCT01407276|P5|Participant Flow|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140296|NCT01407276|P4|Participant Flow|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140297|NCT01407276|P3|Participant Flow|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140298|NCT01407276|P2|Participant Flow|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140299|NCT01407276|P1|Participant Flow|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140300|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140301|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
140302|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140303|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140304|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140305|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140306|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140307|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140308|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140309|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
140310|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140311|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140312|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140313|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140314|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140315|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140316|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140317|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140318|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140319|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
140320|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140321|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140322|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140323|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140324|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140325|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140326|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140327|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140328|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140329|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
140330|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140331|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140332|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140333|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140334|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140335|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140336|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140337|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140338|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140339|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140340|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140341|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140342|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140343|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140344|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140345|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140346|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140347|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140348|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140349|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140350|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140351|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140352|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140353|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140354|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140355|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140579|NCT01405950|P1|Participant Flow|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
140356|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140357|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
140358|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140359|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140360|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140361|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140362|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140363|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140364|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
140365|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140366|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140367|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
140368|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140369|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140370|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140371|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140372|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140373|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140374|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140375|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140376|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140377|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
140378|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140379|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140380|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140381|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140382|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140383|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140384|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140385|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140386|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140387|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
140388|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140389|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140390|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140391|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140392|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140393|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140394|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140395|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140396|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140397|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
140398|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140399|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140400|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140401|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140402|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140403|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140404|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140405|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
140406|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
140407|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
140408|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140409|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140410|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140411|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140412|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140413|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140414|NCT01407276|E8|Reported Event|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
140415|NCT01407276|E7|Reported Event|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
140416|NCT01407276|E6|Reported Event|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
140417|NCT01407276|E5|Reported Event|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
140418|NCT01407276|E4|Reported Event|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
140419|NCT01407276|E3|Reported Event|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
140420|NCT01407276|E2|Reported Event|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
140421|NCT01407276|E1|Reported Event|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
140422|NCT01407068|B1|Baseline|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140423|NCT01407068|P1|Participant Flow|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140424|NCT01407068|O2|Outcome|AA4500 PIP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord"
140425|NCT01407068|O1|Outcome|AA4500 MP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord"
140426|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140427|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140428|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140429|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140430|NCT01407068|E1|Reported Event|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
140431|NCT01406990|B1|Baseline|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
140432|NCT01406990|P1|Participant Flow|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
140433|NCT01406990|O1|Outcome|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
140434|NCT01406990|E1|Reported Event|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
140435|NCT01406938|B3|Baseline|Total|Total of all reporting groups
140436|NCT01406938|B2|Baseline|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140437|NCT01406938|B1|Baseline|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140438|NCT01406938|P6|Participant Flow|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140439|NCT01406938|P5|Participant Flow|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140440|NCT01406938|P4|Participant Flow|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140441|NCT01406938|P3|Participant Flow|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140442|NCT01406938|P2|Participant Flow|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140443|NCT01406938|P1|Participant Flow|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140444|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140445|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140446|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140447|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140448|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140449|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140450|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140451|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140452|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140453|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140454|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140455|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140456|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140457|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140458|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140459|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140460|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140461|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140462|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140463|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140464|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140465|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140466|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140467|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140468|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140469|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140470|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140471|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140472|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140473|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140474|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140475|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140476|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140477|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140478|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140479|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140480|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140481|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140482|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140483|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140484|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140485|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140486|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140487|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140488|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140489|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140490|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140491|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140492|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140493|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140494|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140495|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140496|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140497|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140498|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140499|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140500|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140501|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140502|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140503|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140504|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140505|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140506|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140507|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140508|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140509|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140510|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140511|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140512|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140513|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140514|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140515|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140516|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140517|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140518|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140519|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140521|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140522|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140523|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140524|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140525|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140526|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140527|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140528|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140529|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140530|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140531|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140532|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140533|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140534|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140535|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140536|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140537|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140538|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140539|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140540|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
140541|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
140542|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
140543|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
140544|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
140545|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
140546|NCT01406938|E12|Reported Event|FOLLOW UP-AIN457 300 mg SoR|FOLLOW UP-AIN457 300 mg SoR
140547|NCT01406938|E11|Reported Event|FOLLOW UP-AIN457 150 mg SoR|FOLLOW UP-AIN457 150 mg SoR
140548|NCT01406938|E10|Reported Event|FOLLOW UP-AIN457 300 mg|FOLLOW UP-AIN457 300 mg
140549|NCT01406938|E9|Reported Event|FOLLOW UP-AIN457 150 mg|FOLLOW UP-AIN457 150 mg
140550|NCT01406938|E8|Reported Event|FOLLOW UP-AIN457 300mg IPO|FOLLOW UP-AIN457 300mg IPO
140551|NCT01406938|E7|Reported Event|FOLLOW UP-AIN457 150mg IPO|FOLLOW UP-AIN457 150mg IPO
140552|NCT01406938|E6|Reported Event|ENTIRE-AIN457 300 mg SoR|ENTIRE-AIN457 300 mg SoR
140553|NCT01406938|E5|Reported Event|ENTIRE-AIN457 150 mg SoR|ENTIRE-AIN457 150 mg SoR
140554|NCT01406938|E4|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
140555|NCT01406938|E3|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
140556|NCT01406938|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
140557|NCT01406938|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
140558|NCT01406574|B1|Baseline|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140559|NCT01406574|P4|Participant Flow|OPB-31121: 400mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140560|NCT01406574|P3|Participant Flow|OPB-31121: 200mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140561|NCT01406574|P2|Participant Flow|OPB-31121: 100mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140562|NCT01406574|P1|Participant Flow|OPB-31121: 50mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140563|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140564|NCT01406574|O4|Outcome|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140565|NCT01406574|O3|Outcome|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140566|NCT01406574|O2|Outcome|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
140567|NCT01406574|O1|Outcome|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140568|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140569|NCT01406574|E4|Reported Event|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140570|NCT01406574|E3|Reported Event|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140571|NCT01406574|E2|Reported Event|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140572|NCT01406574|E1|Reported Event|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
140573|NCT01405950|B3|Baseline|Total|Total of all reporting groups
140574|NCT01405950|B2|Baseline|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
140575|NCT01405950|B1|Baseline|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
140576|NCT01405950|P4|Participant Flow|Dose Level 4|Zanaflex Capsules : 0.1 mg/kg
140591|NCT01405937|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140592|NCT01405937|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140593|NCT01405937|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140594|NCT01405937|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140595|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140596|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140597|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140598|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140599|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140600|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140601|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140602|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140603|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140604|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140605|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140606|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140607|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140608|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140609|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140610|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140611|NCT01405937|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140612|NCT01405937|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
140613|NCT01405924|B1|Baseline|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140614|NCT01405924|P1|Participant Flow|Fosaprepitant 150 mg|Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
140615|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140616|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140617|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140618|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140619|NCT01405924|O2|Outcome|Fosaprepitant 150 mg: CT Chemotherapy|Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140620|NCT01405924|O1|Outcome|Fosaprepitant 150 mg: AC-like Chemotherapy|Women with breast cancer receiving AC-like chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140621|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140622|NCT01405924|E1|Reported Event|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
140623|NCT01405898|B3|Baseline|Total|Total of all reporting groups
140624|NCT01405898|B2|Baseline|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140625|NCT01405898|B1|Baseline|Beetroot Juice|Beetroot juice 4 weeks 250ml daily
155088|NCT01344460|O2|Outcome|Unenhanced MRA|
140626|NCT01405898|P2|Participant Flow|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140627|NCT01405898|P1|Participant Flow|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140628|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140629|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140630|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140631|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140632|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140633|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140634|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140635|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140636|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140637|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140638|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140639|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140640|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140641|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140642|NCT01405898|E2|Reported Event|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
140643|NCT01405898|E1|Reported Event|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
140644|NCT01405820|B7|Baseline|Total|Total of all reporting groups
140645|NCT01405820|B6|Baseline|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140646|NCT01405820|B5|Baseline|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140647|NCT01405820|B4|Baseline|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140648|NCT01405820|B3|Baseline|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140649|NCT01405820|B2|Baseline|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
140650|NCT01405820|B1|Baseline|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
140651|NCT01405820|P6|Participant Flow|Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140652|NCT01405820|P5|Participant Flow|Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140653|NCT01405820|P4|Participant Flow|Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140654|NCT01405820|P3|Participant Flow|Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140655|NCT01405820|P2|Participant Flow|Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140656|NCT01405820|P1|Participant Flow|Natalizumab 300 mg Intravenous (IV) Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140657|NCT01405820|O6|Outcome|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140658|NCT01405820|O5|Outcome|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140659|NCT01405820|O4|Outcome|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140660|NCT01405820|O3|Outcome|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140661|NCT01405820|O2|Outcome|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
140662|NCT01405820|O1|Outcome|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
140663|NCT01405820|E12|Reported Event|Open-label Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140664|NCT01405820|E11|Reported Event|Open-label Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140665|NCT01405820|E10|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140666|NCT01405820|E9|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140667|NCT01405820|E8|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140668|NCT01405820|E7|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
140669|NCT01405820|E6|Reported Event|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140670|NCT01405820|E5|Reported Event|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140671|NCT01405820|E4|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
140672|NCT01405820|E3|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
140673|NCT01405820|E2|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
140674|NCT01405820|E1|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
140675|NCT01405794|B1|Baseline|All Participants|
140676|NCT01405794|P1|Participant Flow|All Study Participants|All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).
140677|NCT01405794|O2|Outcome|32ppm Oral Silver|
140678|NCT01405794|O1|Outcome|Placebo|
140679|NCT01405794|O2|Outcome|32ppm Oral Silver|
140680|NCT01405794|O1|Outcome|Placebo|
140681|NCT01405794|O2|Outcome|32ppm Oral Silver|
140682|NCT01405794|O1|Outcome|Placebo|
140683|NCT01405794|O2|Outcome|32ppm Oral Silver|
140684|NCT01405794|O1|Outcome|Placebo|
140685|NCT01405794|O2|Outcome|32ppm Oral Silver|
140686|NCT01405794|O1|Outcome|Placebo|
140687|NCT01405794|O2|Outcome|32ppm Oral Silver|
140688|NCT01405794|O1|Outcome|Placebo|
140689|NCT01405794|O2|Outcome|32ppm Oral Silver|
140690|NCT01405794|O1|Outcome|Placebo|
140691|NCT01405794|O2|Outcome|32ppm Oral Silver|
140692|NCT01405794|O1|Outcome|Placebo|
140693|NCT01405794|O2|Outcome|32ppm Oral Silver|
140694|NCT01405794|O1|Outcome|Placebo|
140695|NCT01405794|O2|Outcome|32ppm Oral Silver|
140696|NCT01405794|O1|Outcome|Placebo|
140697|NCT01405794|O2|Outcome|32ppm Oral Silver|
140698|NCT01405794|O1|Outcome|Placebo|
140699|NCT01405794|O2|Outcome|32ppm Oral Silver|
140700|NCT01405794|O1|Outcome|Placebo|
140701|NCT01405794|O2|Outcome|32ppm Oral Silver|
140702|NCT01405794|O1|Outcome|Placebo|
140703|NCT01405794|O2|Outcome|32ppm Oral Silver|
140704|NCT01405794|O1|Outcome|Placebo|
140705|NCT01405794|O2|Outcome|32ppm Oral Silver|
140706|NCT01405794|O1|Outcome|Placebo|
140707|NCT01405794|O2|Outcome|32ppm Oral Silver|
140708|NCT01405794|O1|Outcome|Placebo|
140709|NCT01405794|O2|Outcome|32ppm Oral Silver|
140710|NCT01405794|O1|Outcome|Placebo|
140711|NCT01405794|O2|Outcome|32ppm Oral Silver|
140712|NCT01405794|O1|Outcome|Placebo|
140713|NCT01405794|O2|Outcome|32ppm Oral Silver|
140714|NCT01405794|O1|Outcome|Placebo|
140715|NCT01405794|O2|Outcome|32ppm Oral Silver|
140716|NCT01405794|O1|Outcome|Placebo|
140717|NCT01405794|O2|Outcome|32ppm Oral Silver|
140718|NCT01405794|O1|Outcome|Placebo|
140719|NCT01405794|O2|Outcome|32ppm Oral Silver|
140720|NCT01405794|O1|Outcome|Placebo|
140721|NCT01405794|O2|Outcome|32ppm Oral Silver|
140722|NCT01405794|O1|Outcome|Placebo|
140723|NCT01405794|O2|Outcome|32ppm Oral Silver|
140724|NCT01405794|O1|Outcome|Placebo|
140725|NCT01405794|O2|Outcome|32ppm Oral Silver|
140726|NCT01405794|O1|Outcome|Placebo|
140727|NCT01405794|O2|Outcome|32ppm Oral Silver|
140728|NCT01405794|O1|Outcome|Placebo|
140729|NCT01405794|O2|Outcome|32ppm Oral Silver|
140730|NCT01405794|O1|Outcome|Placebo|
140731|NCT01405794|O2|Outcome|32ppm Oral Silver|
140732|NCT01405794|O1|Outcome|Placebo|
140733|NCT01405794|O2|Outcome|32ppm Oral Silver|
140734|NCT01405794|O1|Outcome|Placebo|
140735|NCT01405794|O2|Outcome|32ppm Oral Silver|
140736|NCT01405794|O1|Outcome|Placebo|
140737|NCT01405794|O2|Outcome|32ppm Oral Silver|
140738|NCT01405794|O1|Outcome|Placebo|
140739|NCT01405794|O2|Outcome|32ppm Oral Silver|
140740|NCT01405794|O1|Outcome|Placebo|
140741|NCT01405794|O2|Outcome|32ppm Oral Silver|
140742|NCT01405794|O1|Outcome|Placebo|
140743|NCT01405794|O2|Outcome|32ppm Oral Silver|
140744|NCT01405794|O1|Outcome|Placebo|
140745|NCT01405794|O2|Outcome|32ppm Oral Silver|
140746|NCT01405794|O1|Outcome|Placebo|
140747|NCT01405794|E2|Reported Event|Silver Biotics 32 Ppm Diluent|
140748|NCT01405794|E1|Reported Event|ASAP 32 Ppm Solution Experimental|
140749|NCT01405768|B3|Baseline|Total|Total of all reporting groups
140750|NCT01405768|B2|Baseline|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140751|NCT01405768|B1|Baseline|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140776|NCT01405560|P1|Participant Flow|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
155089|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
140752|NCT01405768|P2|Participant Flow|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140753|NCT01405768|P1|Participant Flow|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140754|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140755|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140756|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140757|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140758|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140759|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140760|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140761|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140762|NCT01405768|E2|Reported Event|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
140763|NCT01405768|E1|Reported Event|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
140764|NCT01405742|B1|Baseline|Severe Hemophilia A|Subjects will be randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period.
140765|NCT01405742|P2|Participant Flow|Thrice-Weekly Then Once-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
140766|NCT01405742|P1|Participant Flow|Once-Weekly Then Thrice-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
140767|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
140768|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
140769|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
140770|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
140771|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
140772|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
140773|NCT01405742|E2|Reported Event|Arm B Thrice-weekly F.VIII at 40 IU/kg|Subjects will be randomized to receive thrice-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (once-weekly) for the last 26 weeks, following a 72 hour washout period.
140774|NCT01405742|E1|Reported Event|Arm A Once-weekly F.VIII at 40 IU/kg|Subjects in Arm A will be randomized to receive either once-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (thrice-weekly) for the last 26 weeks, following a 72 hour washout period.
140775|NCT01405560|B1|Baseline|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140777|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140778|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140779|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140780|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140781|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140782|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140783|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140784|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140785|NCT01405560|E1|Reported Event|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
140786|NCT01405508|B5|Baseline|Total Title|
140787|NCT01405508|B4|Baseline|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140788|NCT01405508|B3|Baseline|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140789|NCT01405508|B2|Baseline|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140790|NCT01405508|B1|Baseline|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140791|NCT01405508|P4|Participant Flow|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140792|NCT01405508|P3|Participant Flow|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140793|NCT01405508|P2|Participant Flow|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140794|NCT01405508|P1|Participant Flow|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140795|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140796|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140797|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140798|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140799|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140800|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140801|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140802|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140803|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140804|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140805|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140806|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140902|NCT01404572|B1|Baseline|All Treated|All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
141020|NCT01403805|O1|Outcome|Died Before Oral Care Starting|Number of resident died before the start of oral care
141021|NCT01403805|O1|Outcome|Reject Vaccine|Number of resident to reject vaccine
140807|NCT01405508|E4|Reported Event|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140808|NCT01405508|E3|Reported Event|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
140809|NCT01405508|E2|Reported Event|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140810|NCT01405508|E1|Reported Event|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
140811|NCT01405469|B1|Baseline|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
140812|NCT01405469|P1|Participant Flow|POEM Patients|pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter
140813|NCT01405469|O1|Outcome|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
140814|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140815|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140816|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140817|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140818|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140819|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140820|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140821|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
140822|NCT01405469|E1|Reported Event|POEM Patients|pilot group of achalasia patients who received POEM treatment
140823|NCT01405027|B3|Baseline|Total|Total of all reporting groups
140824|NCT01405027|B2|Baseline|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140825|NCT01405027|B1|Baseline|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140826|NCT01405027|P2|Participant Flow|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140827|NCT01405027|P1|Participant Flow|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140828|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140858|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI) -|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
140829|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140830|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140831|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140832|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140833|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.~Patient education and management skills training: Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140834|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140835|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140836|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140837|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140838|NCT01405027|E2|Reported Event|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140839|NCT01405027|E1|Reported Event|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
140840|NCT01404988|B4|Baseline|Total|Total of all reporting groups
140841|NCT01404988|B3|Baseline|Attention Placebo Intervention (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140859|NCT01404988|E3|Reported Event|Arm 3|"Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.~Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone"
140932|NCT01404572|E1|Reported Event|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A)
140933|NCT01404559|B3|Baseline|Total|Total of all reporting groups
140842|NCT01404988|B2|Baseline|Behavioral and Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
140843|NCT01404988|B1|Baseline|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
140844|NCT01404988|P3|Participant Flow|Attention Placebo Group (API) -|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140845|NCT01404988|P2|Participant Flow|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
140846|NCT01404988|P1|Participant Flow|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
140847|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140848|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
140849|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
140850|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140851|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
140852|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
140853|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140854|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
140855|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
140856|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
140857|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
140895|NCT01404611|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
140860|NCT01404988|E2|Reported Event|Arm 2|"Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.~Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone"
140861|NCT01404988|E1|Reported Event|Arm 1|"Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone."
140862|NCT01404936|B1|Baseline|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
140863|NCT01404936|P1|Participant Flow|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
140864|NCT01404936|O1|Outcome|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
140865|NCT01404936|E1|Reported Event|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
140866|NCT01404923|B3|Baseline|Total|Total of all reporting groups
140867|NCT01404923|B2|Baseline|Standard of Care|anti spasmodic agents: best standard of care prescriptions
140868|NCT01404923|B1|Baseline|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
140869|NCT01404923|P2|Participant Flow|Standard of Care|anti spasmodic agents: best standard of care prescriptions
140870|NCT01404923|P1|Participant Flow|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
140871|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
140872|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
140873|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
140874|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
140875|NCT01404923|E2|Reported Event|Standard of Care|anti spasmodic agents: best standard of care prescriptions
140876|NCT01404923|E1|Reported Event|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
140877|NCT01404832|B1|Baseline|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
140878|NCT01404832|P1|Participant Flow|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
140879|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
140880|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
140881|NCT01404832|E1|Reported Event|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
140882|NCT01404650|B1|Baseline|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140883|NCT01404650|P1|Participant Flow|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140884|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140885|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140886|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140887|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140888|NCT01404650|E1|Reported Event|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
140889|NCT01404611|B4|Baseline|Total|Total of all reporting groups
140890|NCT01404611|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
140891|NCT01404611|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
140892|NCT01404611|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
140893|NCT01404611|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
140894|NCT01404611|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
140903|NCT01404572|P3|Participant Flow|Treatment Sequence C, A, B|Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame.
140904|NCT01404572|P2|Participant Flow|Treatment Sequence B, C, A|Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame.
140905|NCT01404572|P1|Participant Flow|Treatment Sequence A, B, C|Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose.
140906|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140907|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140908|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140909|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140910|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140911|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140912|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140913|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140914|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140915|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
140916|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140917|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140918|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140919|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140920|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140921|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140922|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140923|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140924|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140925|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140926|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140927|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140928|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
140929|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
140930|NCT01404572|E3|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
140931|NCT01404572|E2|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
141022|NCT01403805|O1|Outcome|Reject Oral Care|Number of resident to reject oral care
140934|NCT01404559|B2|Baseline|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
140935|NCT01404559|B1|Baseline|Transtibial Amputees|This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
140936|NCT01404559|P4|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
140937|NCT01404559|P3|Participant Flow|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
140938|NCT01404559|P2|Participant Flow|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
140939|NCT01404559|P1|Participant Flow|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
140940|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
140941|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
140942|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
140943|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
140944|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
140945|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
140946|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
140947|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
140948|NCT01404559|E1|Reported Event|Unilateral Transtibial Amputees|This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.
140949|NCT01404429|B3|Baseline|Total|Total of all reporting groups
140950|NCT01404429|B2|Baseline|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140951|NCT01404429|B1|Baseline|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140952|NCT01404429|P2|Participant Flow|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140953|NCT01404429|P1|Participant Flow|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140954|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140955|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140956|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140957|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140958|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140959|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140960|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140961|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
140962|NCT01404429|E2|Reported Event|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140963|NCT01404429|E1|Reported Event|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
140964|NCT01404260|B3|Baseline|Total|Total of all reporting groups
140965|NCT01404260|B2|Baseline|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
141023|NCT01403805|O1|Outcome|Leaving Nursing Home|Numer of resident for leaving nursing home
140966|NCT01404260|B1|Baseline|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
140967|NCT01404260|P2|Participant Flow|Arm B: Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
140968|NCT01404260|P1|Participant Flow|Arm A: Gefitinib + Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
140969|NCT01404260|O2|Outcome|Arm B: Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
140970|NCT01404260|O1|Outcome|Arm A: Gefitinib+Gemcitabine +Carboplatin|Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
140971|NCT01404260|E2|Reported Event|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
140972|NCT01404260|E1|Reported Event|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
140973|NCT01404234|B1|Baseline|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140974|NCT01404234|P1|Participant Flow|AZLI|Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140975|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140976|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140977|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140978|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140979|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140980|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140981|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140982|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140983|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140984|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140985|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140986|NCT01404234|E1|Reported Event|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
140987|NCT01404078|B3|Baseline|Total|Total of all reporting groups
140988|NCT01404078|B2|Baseline|Polycap Double Dose Plus Potassium|"Patients in this arm received one dose of low strength Polycap with potassium~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140989|NCT01404078|B1|Baseline|Polycap Single Dose|Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
140990|NCT01404078|P2|Participant Flow|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140991|NCT01404078|P1|Participant Flow|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140992|NCT01404078|O2|Outcome|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140993|NCT01404078|O1|Outcome|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140994|NCT01404078|E2|Reported Event|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140995|NCT01404078|E1|Reported Event|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
140996|NCT01403987|B4|Baseline|Total|Total of all reporting groups
140997|NCT01403987|B3|Baseline|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
140998|NCT01403987|B2|Baseline|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
140999|NCT01403987|B1|Baseline|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141000|NCT01403987|P3|Participant Flow|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
141001|NCT01403987|P2|Participant Flow|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
141002|NCT01403987|P1|Participant Flow|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141003|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
141004|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
141005|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141006|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
141007|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
141008|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141009|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
141010|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
141011|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141012|NCT01403987|E3|Reported Event|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
141013|NCT01403987|E2|Reported Event|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
141014|NCT01403987|E1|Reported Event|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
141015|NCT01403805|B3|Baseline|Total|Total of all reporting groups
141016|NCT01403805|B2|Baseline|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
141017|NCT01403805|B1|Baseline|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
141018|NCT01403805|P2|Participant Flow|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
141019|NCT01403805|P1|Participant Flow|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
141024|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
141025|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
141026|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
141027|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
141028|NCT01403805|E2|Reported Event|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
141029|NCT01403805|E1|Reported Event|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
141030|NCT01403376|B4|Baseline|Total|Total of all reporting groups
141031|NCT01403376|B3|Baseline|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141032|NCT01403376|B2|Baseline|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141033|NCT01403376|B1|Baseline|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141034|NCT01403376|P3|Participant Flow|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141035|NCT01403376|P2|Participant Flow|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141036|NCT01403376|P1|Participant Flow|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141037|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141038|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141039|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141040|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141041|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141042|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141043|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141044|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141045|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141046|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141047|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141048|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141049|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141050|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141051|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141052|NCT01403376|E3|Reported Event|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
141053|NCT01403376|E2|Reported Event|Teriflunomide 14mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
141054|NCT01403376|E1|Reported Event|Teriflunomide 7mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
141055|NCT01403194|B1|Baseline|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141056|NCT01403194|P1|Participant Flow|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141057|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141058|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141059|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141060|NCT01403194|E1|Reported Event|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
141061|NCT01403090|B1|Baseline|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
141062|NCT01403090|P1|Participant Flow|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
141063|NCT01403090|O1|Outcome|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
141064|NCT01403090|E1|Reported Event|Angel Catheter|
141065|NCT01403051|B3|Baseline|Total|Total of all reporting groups
141066|NCT01403051|B2|Baseline|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141067|NCT01403051|B1|Baseline|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141068|NCT01403051|P2|Participant Flow|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141069|NCT01403051|P1|Participant Flow|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141070|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141071|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141072|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141073|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141074|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141127|NCT01402869|E3|Reported Event|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141156|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141075|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141076|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141077|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141078|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141079|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141080|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141081|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141082|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141083|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141084|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141085|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141086|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141128|NCT01402869|E2|Reported Event|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141087|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141088|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141089|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141090|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141091|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141092|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141093|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141094|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141095|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141096|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141097|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141098|NCT01403051|E2|Reported Event|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141129|NCT01402869|E1|Reported Event|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141099|NCT01403051|E1|Reported Event|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
141100|NCT01402947|B3|Baseline|Total|Total of all reporting groups
141101|NCT01402947|B2|Baseline|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
141102|NCT01402947|B1|Baseline|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
141103|NCT01402947|P2|Participant Flow|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
141104|NCT01402947|P1|Participant Flow|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
141105|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
141106|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
141107|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
141108|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
141109|NCT01402947|E2|Reported Event|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
141110|NCT01402947|E1|Reported Event|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
141111|NCT01402869|B4|Baseline|Total|Total of all reporting groups
141112|NCT01402869|B3|Baseline|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141113|NCT01402869|B2|Baseline|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141114|NCT01402869|B1|Baseline|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141115|NCT01402869|P3|Participant Flow|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141116|NCT01402869|P2|Participant Flow|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141117|NCT01402869|P1|Participant Flow|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141118|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141119|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141120|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141121|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141122|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141123|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141124|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
141125|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141126|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
141157|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141130|NCT01402817|B1|Baseline|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
141131|NCT01402817|P1|Participant Flow|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
141132|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
141133|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
141134|NCT01402817|E1|Reported Event|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
141135|NCT01402700|B1|Baseline|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
141136|NCT01402700|P1|Participant Flow|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
141137|NCT01402700|O1|Outcome|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
141138|NCT01402700|E1|Reported Event|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
141139|NCT01402570|B1|Baseline|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
141140|NCT01402570|P1|Participant Flow|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
141141|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
141142|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
141143|NCT01402570|O1|Outcome|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
141144|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
141145|NCT01402570|E1|Reported Event|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
141146|NCT01402427|B3|Baseline|Total|Total of all reporting groups
141147|NCT01402427|B2|Baseline|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141148|NCT01402427|B1|Baseline|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141149|NCT01402427|P2|Participant Flow|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141150|NCT01402427|P1|Participant Flow|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141151|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141152|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141153|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141154|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141155|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141158|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141159|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141160|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141161|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141162|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141163|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141164|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141165|NCT01402427|E2|Reported Event|Placebo|Placebo: Intraarterial administration of 10 mL saline.
141166|NCT01402427|E1|Reported Event|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
141167|NCT01402141|B3|Baseline|Total|Total of all reporting groups
141168|NCT01402141|B2|Baseline|Placebo(35g)|
141169|NCT01402141|B1|Baseline|Chungkookjang(35g)|
141170|NCT01402141|P2|Participant Flow|Placebo|"Placebo(3times/day, 3packs/day, 35g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Chungkookjang."
141171|NCT01402141|P1|Participant Flow|Chungkookjang|"Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks~Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying"
141172|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141173|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141174|NCT01402141|O2|Outcome|Placeb|Oral intake placebo(35g/day) for 12weeks
141175|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141176|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141177|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141178|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141179|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141180|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141181|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141182|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141183|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141184|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141185|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141186|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
141187|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
141188|NCT01402141|E2|Reported Event|Placebo(35g)|Oral intake placebo(35g/day) for 12weeks
141189|NCT01402141|E1|Reported Event|Chungkookjang(35g)|Oral intake Chungkookjang(35g) for 12weeks.
141190|NCT01402128|B3|Baseline|Total|Total of all reporting groups
141191|NCT01402128|B2|Baseline|Placebo|Placebo for 12 weeks
141192|NCT01402128|B1|Baseline|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141193|NCT01402128|P2|Participant Flow|Placebo|"Placebo(1times/day, 1packs/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Barley beta-glucan"
141194|NCT01402128|P1|Participant Flow|Barley Beta-glucan|"Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks~Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process."
141195|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141196|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141197|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141198|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141199|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141200|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141201|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141202|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141203|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141204|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141205|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141206|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141207|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141208|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141209|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141210|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141211|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141212|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141213|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141214|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141215|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
141216|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141217|NCT01402128|E2|Reported Event|Placebo|Placebo for 12 weeks
141218|NCT01402128|E1|Reported Event|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
141219|NCT01402115|B3|Baseline|Total|Total of all reporting groups
141220|NCT01402115|B2|Baseline|Placebo|Placebo 15mg for 12 weeks
141221|NCT01402115|B1|Baseline|Polycan|Polycan 150mg for 12 weeks
141222|NCT01402115|P2|Participant Flow|Placebo|Placebo 15mg for 12 weeks
141223|NCT01402115|P1|Participant Flow|Polycan|Polycan 150mg for 12 weeks
141224|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
141225|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
141226|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
141239|NCT01402102|P2|Participant Flow|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141240|NCT01402102|P1|Participant Flow|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141241|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141242|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141243|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141244|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141245|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141246|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141247|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141248|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141249|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
141250|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
141251|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
141252|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
141253|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141254|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141255|NCT01402102|E2|Reported Event|Placebo|Oral intake placebo(6.0g/day) for 12weeks
141256|NCT01402102|E1|Reported Event|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
141257|NCT01402063|B3|Baseline|Total|Total of all reporting groups
141258|NCT01402063|B2|Baseline|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
141259|NCT01402063|B1|Baseline|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
141260|NCT01402063|P2|Participant Flow|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
141261|NCT01402063|P1|Participant Flow|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
141262|NCT01402063|O2|Outcome|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
141263|NCT01402063|O1|Outcome|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
141264|NCT01402063|E2|Reported Event|Radiation + Temozolomide and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
141265|NCT01402063|E1|Reported Event|Radiation Plus PPX and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
141266|NCT01401842|B3|Baseline|Total|Total of all reporting groups
141267|NCT01401842|B2|Baseline|Stabilization Exercise|Low intensity core stabilization exercise
141268|NCT01401842|B1|Baseline|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141269|NCT01401842|P2|Participant Flow|Stabilization Exercise|Low intensity core stabilization exercise
141270|NCT01401842|P1|Participant Flow|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141271|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
141272|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141273|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
141274|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141275|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
141276|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141277|NCT01401842|E2|Reported Event|Stabilization Exercise|Low intensity core stabilization exercise
141278|NCT01401842|E1|Reported Event|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
141279|NCT01400698|B5|Baseline|Total|Total of all reporting groups
141280|NCT01400698|B4|Baseline|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141281|NCT01400698|B3|Baseline|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141282|NCT01400698|B2|Baseline|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141283|NCT01400698|B1|Baseline|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141284|NCT01400698|P6|Participant Flow|Observation (C)|Participants with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
141285|NCT01400698|P5|Participant Flow|Observed Then Randomized to Observation (B2)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
141286|NCT01400698|P4|Participant Flow|Observed Then Randomized to Saizen® (B1)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
141287|NCT01400698|P3|Participant Flow|Observed, Not Randomized (B0)|Participants with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
141288|NCT01400698|P2|Participant Flow|Saizen® Intermittent (A2)|Participants with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
141289|NCT01400698|P1|Participant Flow|Saizen® Continuous (A1)|Participants with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
141290|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141291|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141292|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141293|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141294|NCT01400698|O2|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141295|NCT01400698|O1|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141296|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141297|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141298|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141299|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141300|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141301|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141302|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141303|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141304|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141305|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141306|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141364|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
141365|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
141307|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141308|NCT01400698|E2|Reported Event|Treated|Included all participants who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141309|NCT01400698|E1|Reported Event|Not Treated|Included all participants who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
141310|NCT01401647|B4|Baseline|Total|Total of all reporting groups
141311|NCT01401647|B3|Baseline|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
141312|NCT01401647|B2|Baseline|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
141313|NCT01401647|B1|Baseline|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
141314|NCT01401647|P3|Participant Flow|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
141315|NCT01401647|P2|Participant Flow|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
141316|NCT01401647|P1|Participant Flow|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
141317|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
141318|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
141319|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
141320|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
141321|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
141322|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
141366|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
141367|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
141323|NCT01401647|E3|Reported Event|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
141324|NCT01401647|E2|Reported Event|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
141325|NCT01401647|E1|Reported Event|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
141326|NCT01401517|B4|Baseline|Total|Total of all reporting groups
141327|NCT01401517|B3|Baseline|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141328|NCT01401517|B2|Baseline|40 mg Sodium Nitrite|"40 mg dose, BID~40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141329|NCT01401517|B1|Baseline|Placebo|Placebo twice each day for 11 weeks
141330|NCT01401517|P3|Participant Flow|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141331|NCT01401517|P2|Participant Flow|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141332|NCT01401517|P1|Participant Flow|Placebo|sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
141333|NCT01401517|O3|Outcome|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite:80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141334|NCT01401517|O2|Outcome|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141335|NCT01401517|O1|Outcome|Placebo|0 mg twice each day for 11 weeks.
141336|NCT01401517|E3|Reported Event|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141337|NCT01401517|E2|Reported Event|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
141338|NCT01401517|E1|Reported Event|Placebo|sodium nitrite: 0 mg twice each day for 11 weeks .
141339|NCT01401478|B1|Baseline|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141340|NCT01401478|P1|Participant Flow|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141341|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141342|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141343|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141344|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141345|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141346|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141347|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141348|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141349|NCT01401478|E1|Reported Event|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
141350|NCT01401465|B3|Baseline|Total|Total of all reporting groups
141351|NCT01401465|B2|Baseline|Sequence MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
141352|NCT01401465|B1|Baseline|Sequence CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
141353|NCT01401465|P2|Participant Flow|MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
141354|NCT01401465|P1|Participant Flow|CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
141355|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141356|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141357|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141358|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141359|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141360|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141361|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141362|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141363|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
141368|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
141369|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141370|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141371|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141372|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141373|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141374|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141375|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141376|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141377|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141378|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141379|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141380|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141381|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141382|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141383|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141384|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141385|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141386|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141387|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141388|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141389|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141390|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141391|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141392|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141393|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141394|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141395|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141396|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141397|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141398|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141399|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141400|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141401|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141402|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141403|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141404|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141405|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141406|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141407|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141408|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141409|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141410|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141411|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
141412|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141413|NCT01401465|O1|Outcome|Ciclesonide Versus Mometasone|This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide
141414|NCT01401465|E2|Reported Event|Mometasone|Mometasone AQ 200 mcg
141415|NCT01401465|E1|Reported Event|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
141416|NCT01401361|B1|Baseline|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141417|NCT01401361|P1|Participant Flow|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141418|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141419|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141420|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141421|NCT01401361|E1|Reported Event|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
141422|NCT01401322|B1|Baseline|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
141423|NCT01401322|P1|Participant Flow|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
141502|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141424|NCT01401322|O1|Outcome|Lenalidomide 50 mg/Day x 28 Days|"Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.~Lenalidomide: 50 mg; po"
141425|NCT01401322|E1|Reported Event|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
141426|NCT01401283|B3|Baseline|Total|Total of all reporting groups
141427|NCT01401283|B2|Baseline|Control Group|hemodynamic management according to institutional clinical standards
141428|NCT01401283|B1|Baseline|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
141429|NCT01401283|P2|Participant Flow|Control Group|hemodynamic management according to institutional clinical standards
141430|NCT01401283|P1|Participant Flow|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
141431|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
141432|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
141433|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
141434|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
141435|NCT01401283|E2|Reported Event|Control Group|hemodynamic management according to institutional clinical standards
141436|NCT01401283|E1|Reported Event|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
141437|NCT01401257|B5|Baseline|Total|Total of all reporting groups
141438|NCT01401257|B4|Baseline|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
141439|NCT01401257|B3|Baseline|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141440|NCT01401257|B2|Baseline|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141441|NCT01401257|B1|Baseline|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141442|NCT01401257|P4|Participant Flow|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
141443|NCT01401257|P3|Participant Flow|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141444|NCT01401257|P2|Participant Flow|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141445|NCT01401257|P1|Participant Flow|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141446|NCT01401257|O4|Outcome|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
141447|NCT01401257|O3|Outcome|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141448|NCT01401257|O2|Outcome|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141449|NCT01401257|O1|Outcome|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141450|NCT01401257|E4|Reported Event|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
141451|NCT01401257|E3|Reported Event|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141452|NCT01401257|E2|Reported Event|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141453|NCT01401257|E1|Reported Event|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
141454|NCT01401166|B1|Baseline|Trastuzumab Subcutaneously and Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 18 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. For up to 10 remaining cycles, participants received either trastuzumab 6 mg/kg IV or trastuzumab 600 mg SC using the single-use injection device (Cohort 1) or trastuzumab 600 mg SC (Cohort 2).
141455|NCT01401166|P4|Participant Flow|Cohort 2|Participants received trastuzumab 600 mg/kg subcutaneously on Day 1 of each 3-week cycle for up to 10 remaining cycles. Following the end of treatment, participants were followed for 3 years for safety.
141456|NCT01401166|P3|Participant Flow|Cohort 1|Participants received trastuzumab 6 mg/kg intravenously on Day 1 of each 3-week cycle for up to 10 remaining cycles. Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner. Following the end of treatment, participants were followed for 3 years for safety.
141457|NCT01401166|P2|Participant Flow|Trastuzumab Intravenously Then Trastuzumab Subcutaneously|Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles of the crossover period. During cycles 1-4, they received trastuzumab 6 mg/kg intravenously (IV) and during cycles 5-8, they received trastuzumab 600 mg subcutaneously (SC). In case Cycle 1 of the cross-over period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
141458|NCT01401166|P1|Participant Flow|Trastuzumab Subcutaneously Then Trastuzumab Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles of the crossover period. During cycles 1-4, they received trastuzumab 600 mg subcutaneously (SC) and during cycles 5-8, they received trastuzumab 6 mg/kg intravenously (IV).
141459|NCT01401166|O1|Outcome|Trastuzumab Self-administered Subcutaneously – Cohort 1|Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner.
141460|NCT01401166|O1|Outcome|Trastuzumab Subcutaneously and Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 18 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. For up to 10 remaining cycles, participants received either trastuzumab 6 mg/kg IV or trastuzumab 600 mg SC using the single-use injection device (Cohort 1) or trastuzumab 600 mg SC (Cohort 2).
141461|NCT01401166|O1|Outcome|Trastuzumab Subcutaneously and Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. In case Cycle 1 of the crossover period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
141462|NCT01401166|O1|Outcome|Trastuzumab Subcutaneously and Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. In case Cycle 1 of the crossover period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
141463|NCT01401166|O1|Outcome|Trastuzumab Subcutaneously and Intravenously|Participants received trastuzumab on Day 1 of each 3-week cycle for 8 cycles. They either received trastuzumab 600 mg subcutaneously (SC) for 4 cycles followed by trastuzumab 6 mg/kg intravenously (IV) for 4 cycles or trastuzumab 6 mg/kg intravenously (IV) for 4 cycles followed by trastuzumab 600 mg subcutaneously (SC) for 4 cycles. In case Cycle 1 of the crossover period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
141464|NCT01401166|E8|Reported Event|Cohort 2 - Safety Follow-up Period|Participants were followed for 3 years for safety.
141465|NCT01401166|E7|Reported Event|Cohort 1 - Safety Follow-up Period|Participants were followed for 3 years for safety.
141466|NCT01401166|E6|Reported Event|Trastuzumab SC – Cohort 2 – Continuation Period|Participants received trastuzumab 600 mg/kg subcutaneously on Day 1 of each 3-week cycle for up to 10 remaining cycles.
141467|NCT01401166|E5|Reported Event|Trastuzumab IV – Cohort 2 – Continuation Period|Participants received trastuzumab 6 mg/kg intravenously on Day 1 of each 3-week cycle for up to 10 remaining cycles.
141468|NCT01401166|E4|Reported Event|Trastuzumab Self-administered SC – Cohort 1 – Cont|Participants in Cohort 1, who had at least 2 treatment cycles remaining of their 18-cycle treatment course, were offered the opportunity to self-administer trastuzumab 600 mg subcutaneously using the single-injection device on Day 1 of each 3-week cycle under the direction of a trained health care practitioner.
141469|NCT01401166|E3|Reported Event|Trastuzumab IV – Cohort 1 – Continuation Period|Participants received trastuzumab 6 mg/kg intravenous Participants received trastuzumab 6 mg/kg intravenously on Day 1 of each 3-week cycle for up to 10 remaining cycles.
141470|NCT01401166|E2|Reported Event|Trastuzumab IV – Crossover Period|Participants received trastuzumab 6 mg/kg intravenously (IV) on Day 1 of each 3-week cycle for 4 cycles. In case Cycle 1 of the crossover period was the first cycle of trastuzumab treatment, a loading dose of trastuzumab 8 mg/kg IV was administered.
141471|NCT01401166|E1|Reported Event|Trastuzumab SC – Crossover Period|Participants received trastuzumab 600 mg subcutaneously (SC) on Day 1 of each 3-week cycle for 4 cycles.
141472|NCT01401153|B3|Baseline|Total|Total of all reporting groups
141473|NCT01401153|B2|Baseline|Skipping Lunch|No lunch (water)
141474|NCT01401153|B1|Baseline|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
141475|NCT01401153|P2|Participant Flow|Skipping Lunch|No lunch (water)
141476|NCT01401153|P1|Participant Flow|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
141477|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141478|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141479|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141480|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141481|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141482|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141483|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141484|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141485|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141486|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141487|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141488|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141489|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141490|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141491|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141492|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141493|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141494|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141495|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water) o
141496|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141497|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141498|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141499|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141500|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
141501|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
141508|NCT01401101|B2|Baseline|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
141509|NCT01401101|B1|Baseline|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
141510|NCT01401101|P2|Participant Flow|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
141511|NCT01401101|P1|Participant Flow|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
141512|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
141513|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
141514|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
141515|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
141516|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
141517|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
141518|NCT01401101|E2|Reported Event|Treatment-as-Usual (TAU)|The TAU condition consists of only the clinician education and patient screening without written feedback.
141519|NCT01401101|E1|Reported Event|PTSD Care Management (PCM)|There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
141520|NCT01401049|B3|Baseline|Total|Total of all reporting groups
141521|NCT01401049|B2|Baseline|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
141522|NCT01401049|B1|Baseline|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
141548|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
141549|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
141523|NCT01401049|P2|Participant Flow|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
141524|NCT01401049|P1|Participant Flow|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
141525|NCT01401049|O2|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
141526|NCT01401049|O1|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
141527|NCT01401049|E2|Reported Event|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
141528|NCT01401049|E1|Reported Event|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
141529|NCT01401023|B1|Baseline|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141530|NCT01401023|P1|Participant Flow|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141531|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141532|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141533|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141534|NCT01401023|E1|Reported Event|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
141535|NCT01401010|B3|Baseline|Total|Total of all reporting groups
141536|NCT01401010|B2|Baseline|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
141537|NCT01401010|B1|Baseline|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
141538|NCT01401010|P2|Participant Flow|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
141539|NCT01401010|P1|Participant Flow|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
141540|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
141541|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
141542|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
141543|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
141544|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
141545|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
141546|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
141547|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
142573|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
141550|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
141551|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
141552|NCT01401010|O4|Outcome|1000 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
141553|NCT01401010|O3|Outcome|1000 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
141554|NCT01401010|O2|Outcome|500 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
141555|NCT01401010|O1|Outcome|500 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
141556|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
141557|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
141558|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
141559|NCT01401010|E2|Reported Event|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
141560|NCT01401010|E1|Reported Event|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
141561|NCT01400958|B3|Baseline|Total|Total of all reporting groups
141562|NCT01400958|B2|Baseline|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141563|NCT01400958|B1|Baseline|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141564|NCT01400958|P2|Participant Flow|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141565|NCT01400958|P1|Participant Flow|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141566|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141567|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141568|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141569|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141667|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141570|NCT01400958|E2|Reported Event|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141571|NCT01400958|E1|Reported Event|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
141572|NCT01400932|B3|Baseline|Total|Total of all reporting groups
141573|NCT01400932|B2|Baseline|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141574|NCT01400932|B1|Baseline|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141575|NCT01400932|P2|Participant Flow|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141576|NCT01400932|P1|Participant Flow|GI148512|Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141577|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141578|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141579|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141580|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141581|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141582|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141583|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141584|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141585|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141586|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141587|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141588|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141589|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141590|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141591|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141592|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141593|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141594|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141850|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141595|NCT01400932|E2|Reported Event|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141596|NCT01400932|E1|Reported Event|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
141597|NCT01400919|B1|Baseline|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
141598|NCT01400919|P1|Participant Flow|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
141599|NCT01400919|O1|Outcome|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
141600|NCT01400919|E1|Reported Event|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
141601|NCT01400906|B1|Baseline|Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
141602|NCT01400906|P6|Participant Flow|Sequence 6: FP 500 µg, FP 100 µg, Placebo|Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
141603|NCT01400906|P5|Participant Flow|Sequence 5: FP 500 µg, Placebo, FP 100 µg|Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
141604|NCT01400906|P4|Participant Flow|Sequence 4: FP 100 µg, FP 500 µg, Placebo|Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
141605|NCT01400906|P3|Participant Flow|Sequence 3: FP 100 µg, Placebo, FP 500 µg|Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
141606|NCT01400906|P2|Participant Flow|Sequence 2: Placebo, FP 500 µg, FP 100 µg|Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
141607|NCT01400906|P1|Participant Flow|Sequence 1: Placebo, FP 100 µg, FP 500 µg|Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
141608|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141609|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141610|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141611|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141668|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141612|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141613|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141614|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141615|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141616|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141617|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141618|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141619|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141620|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141621|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141622|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141623|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141624|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141625|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141626|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141627|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141628|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141629|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141630|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141631|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141632|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141633|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141634|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141758|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141635|NCT01400906|E3|Reported Event|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141636|NCT01400906|E2|Reported Event|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141637|NCT01400906|E1|Reported Event|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
141638|NCT01400880|B1|Baseline|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
141639|NCT01400880|P1|Participant Flow|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
141640|NCT01400880|O1|Outcome|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
141641|NCT01400880|E1|Reported Event|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
141642|NCT01400841|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141643|NCT01400841|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141644|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141645|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141646|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141647|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141648|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141649|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141650|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141651|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141652|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141653|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141654|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141655|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141656|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141657|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141658|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141659|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141660|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141661|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141662|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141663|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141664|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141665|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141666|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141759|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141669|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141670|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141671|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141672|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141673|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141674|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141675|NCT01400841|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
141676|NCT01400451|B4|Baseline|Total|Total of all reporting groups
141677|NCT01400451|B3|Baseline|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
141678|NCT01400451|B2|Baseline|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
141679|NCT01400451|B1|Baseline|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment."
141680|NCT01400451|P3|Participant Flow|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator’s discretion.
141681|NCT01400451|P2|Participant Flow|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
141682|NCT01400451|P1|Participant Flow|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment."
141683|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
141684|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily continuing during combination treatment.
141685|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
141686|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
141687|NCT01400451|O3|Outcome|720 mg Vemurafenib Alone|"These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.~Events from first day of vemurafenib to last day of treatment + 90 days, up to date of data cut off for Primary Endpoint."
141688|NCT01400451|O2|Outcome|720 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
141689|NCT01400451|O1|Outcome|960 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
141690|NCT01400451|E5|Reported Event|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
141691|NCT01400451|E4|Reported Event|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
141692|NCT01400451|E3|Reported Event|Lead- In Period 720 mg Vemurafenib Alone|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
141693|NCT01400451|E2|Reported Event|Lead-In Period 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
141694|NCT01400451|E1|Reported Event|Lead-In Period 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
141695|NCT01400425|B1|Baseline|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141696|NCT01400425|P1|Participant Flow|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141697|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141698|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141699|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141700|NCT01400425|O3|Outcome|Subjects With a Negative Scan|Subjects with progressive cognitive decline that received a negative scan.
141701|NCT01400425|O2|Outcome|Subjectss With a Positive Scan|Subjects with progressive cognitive decline that received a positive florbetapir scan.
141702|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141703|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141704|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141705|NCT01400425|E1|Reported Event|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
141706|NCT01400412|B3|Baseline|Total|Total of all reporting groups
141707|NCT01400412|B2|Baseline|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141760|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141761|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141762|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141763|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
155090|NCT01344460|O2|Outcome|Unenhanced MRA|
141708|NCT01400412|B1|Baseline|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141709|NCT01400412|P2|Participant Flow|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141710|NCT01400412|P1|Participant Flow|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141711|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141712|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141713|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141714|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141715|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141716|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141764|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141765|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141766|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141767|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141768|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141717|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141718|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141719|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141720|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141721|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141722|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141723|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141724|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141725|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141769|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141770|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141771|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141772|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
155091|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
141726|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141727|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141728|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141729|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141730|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141731|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141732|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141733|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141734|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141773|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141774|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141775|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141776|NCT01400243|E2|Reported Event|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141777|NCT01400243|E1|Reported Event|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141735|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141736|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141737|NCT01400412|O2|Outcome|TDF Arm: DRV/r + TDF + FTC + MVC Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet."
141738|NCT01400412|O1|Outcome|MVC Arm: DRV/r + MVC + FTC + TDF Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.~Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet."
141739|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141740|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141741|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141742|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141743|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141778|NCT01400139|B1|Baseline|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141779|NCT01400139|P1|Participant Flow|Hydrocodone Bitartrate (HYD)|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
155092|NCT01344460|O2|Outcome|Unenhanced MRA|
141744|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141745|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141746|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141747|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141748|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141749|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141750|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141751|NCT01400412|E2|Reported Event|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
141752|NCT01400412|E1|Reported Event|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
141753|NCT01400243|B3|Baseline|Total|Total of all reporting groups
141754|NCT01400243|B2|Baseline|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141755|NCT01400243|B1|Baseline|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
141756|NCT01400243|P2|Participant Flow|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
141757|NCT01400243|P1|Participant Flow|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
155093|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
141780|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141781|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141782|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141783|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141784|NCT01400139|E2|Reported Event|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141785|NCT01400139|E1|Reported Event|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
141786|NCT01400113|B3|Baseline|Total|Total of all reporting groups
141787|NCT01400113|B2|Baseline|Placebo|60 patients were randomized to this group
141788|NCT01400113|B1|Baseline|Asenapine|60 patients were randomized to this group
141789|NCT01400113|P2|Participant Flow|Placebo|60 patients were randomized to this group
141790|NCT01400113|P1|Participant Flow|Asenapine|60 patients were randomized to this group
141791|NCT01400113|O2|Outcome|Placebo|60 patients were randomized to this group
141792|NCT01400113|O1|Outcome|Asenapine|60 patients were randomized to this group
141793|NCT01400113|E2|Reported Event|Placebo|Placebo: Placebo Sublingual Tablet, single-dose
141794|NCT01400113|E1|Reported Event|Asenapine|Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
141795|NCT01399866|B3|Baseline|Total|Total of all reporting groups
141796|NCT01399866|B2|Baseline|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
141797|NCT01399866|B1|Baseline|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
141798|NCT01399866|P2|Participant Flow|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
141799|NCT01399866|P1|Participant Flow|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
141800|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
141801|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
141802|NCT01399866|E2|Reported Event|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
141803|NCT01399866|E1|Reported Event|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
141804|NCT01399788|B1|Baseline|Entire Study Population|Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
141805|NCT01399788|P2|Participant Flow|Four Single Drug References First, Then Myrin-P Forte|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
141806|NCT01399788|P1|Participant Flow|Myrin-P Forte First, Then Four Single Drug References|Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period.
141807|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141808|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141809|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141810|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141811|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141812|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141813|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141814|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141815|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
142574|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
141816|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141817|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141818|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141819|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141820|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141821|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141822|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141823|NCT01399788|E2|Reported Event|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
141824|NCT01399788|E1|Reported Event|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
141825|NCT01399723|B3|Baseline|Total|Total of all reporting groups
141826|NCT01399723|B2|Baseline|Penicillin|Benzyl penicillin 50000 IU 6 hourly
141827|NCT01399723|B1|Baseline|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
141828|NCT01399723|P2|Participant Flow|Benzyl Penicillin 50,000IU/kg 6 Hourly|Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
141829|NCT01399723|P1|Participant Flow|Amoxicillin 45mg/kg 12 Hourly|Amoxicillin: Oral 45mg/kg 12 hourly
141830|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
141831|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
141832|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
141833|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
141834|NCT01399723|O2|Outcome|Penicillin|Benzyl penicillin 50000 IU/kg 6 hourly
141835|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
141836|NCT01399723|E2|Reported Event|Benzyl Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
141837|NCT01399723|E1|Reported Event|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
141838|NCT01399697|B4|Baseline|Total|Total of all reporting groups
141839|NCT01399697|B3|Baseline|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
141840|NCT01399697|B2|Baseline|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
141841|NCT01399697|B1|Baseline|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
141842|NCT01399697|P3|Participant Flow|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
141843|NCT01399697|P2|Participant Flow|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
141844|NCT01399697|P1|Participant Flow|Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)|Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
141845|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141846|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141847|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141848|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141849|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
142510|NCT01396265|B1|Baseline|Overall Study|This was a open-label, two period, fixed sequence trial clinical phase I trial in healthy male volunteers.
141851|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141852|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141853|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141854|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141855|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141856|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141857|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141858|NCT01399697|O1|Outcome|Tocilizumab + Methotrexate (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141859|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141860|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141861|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
141862|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
141863|NCT01399697|E5|Reported Event|TCZ + Placebo (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
141864|NCT01399697|E4|Reported Event|TCZ + MTX (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
141865|NCT01399697|E3|Reported Event|TCZ + Placebo (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2.
141866|NCT01399697|E2|Reported Event|TCZ + MTX (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2.
141867|NCT01399697|E1|Reported Event|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
141868|NCT01399619|B3|Baseline|Total|Total of all reporting groups
141869|NCT01399619|B2|Baseline|Faldaprevir 240mg -T|patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
141870|NCT01399619|B1|Baseline|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141871|NCT01399619|P4|Participant Flow|Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)|Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
141872|NCT01399619|P3|Participant Flow|Faldaprevir 240mg-24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141873|NCT01399619|P2|Participant Flow|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141874|NCT01399619|P1|Participant Flow|Faldaprevir 120mg -24W|Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141875|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141876|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141877|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141878|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141879|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141880|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141881|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141882|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141883|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141884|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141885|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141886|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141887|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141888|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141889|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141890|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141891|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141892|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141893|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141894|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141895|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141896|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141897|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141898|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141899|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141900|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141901|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141902|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141903|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141904|NCT01399619|O1|Outcome|Faldaprevir 120mg -24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141905|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141906|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141907|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141908|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141909|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141910|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141911|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141912|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141913|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141914|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141915|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141916|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141917|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141918|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141919|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141920|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141921|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141922|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141923|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141924|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141925|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
141926|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141927|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141928|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141929|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141930|NCT01399619|E4|Reported Event|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
141931|NCT01399619|E3|Reported Event|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141932|NCT01399619|E2|Reported Event|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141933|NCT01399619|E1|Reported Event|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
141934|NCT01399229|B1|Baseline|Pregnant|The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
141935|NCT01399229|P3|Participant Flow|Pregnant, Term, Non Labor|Pregnant term women independently determined to be in labor.
141936|NCT01399229|P2|Participant Flow|Pregnant, Preterm, Non Labor|Pregnant preterm women independently determined to not be in labor.
141937|NCT01399229|P1|Participant Flow|Pregnant, Preterm, In Labor|Pregnant preterm women independently determined to be in labor.
141938|NCT01399229|O1|Outcome|Pregnant Patents With Uterine Contractions|Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
141939|NCT01399229|E1|Reported Event|Pregnant|
141940|NCT01399190|B1|Baseline|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141941|NCT01399190|P1|Participant Flow|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141942|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141943|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141944|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141945|NCT01399190|E1|Reported Event|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
141946|NCT01399125|B3|Baseline|Total|Total of all reporting groups
141947|NCT01399125|B2|Baseline|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141948|NCT01399125|B1|Baseline|Rivastigmine Patch|Once-daily target patch size 10 cm²
141949|NCT01399125|P2|Participant Flow|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141950|NCT01399125|P1|Participant Flow|Rivastigmine Patch|Once-daily target patch size 10 cm²
141951|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141952|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
141953|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141954|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
141955|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141956|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
141957|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141958|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
141959|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
141960|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
141961|NCT01399125|E2|Reported Event|Rivastigmine Capsule|Twice-daily target dose of 6 mg oral capsule
141962|NCT01399125|E1|Reported Event|Rivastigmine Patch|Once-daily target patch size 10 cm²
141963|NCT01399099|B1|Baseline|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
141964|NCT01399099|P1|Participant Flow|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
141965|NCT01399099|O2|Outcome|Control Side|Half of the abdomnioplasty incision was treated according to the Investigator’s standard of care. Participant served as his/her own control.
141966|NCT01399099|O1|Outcome|Treated Side|Half of the abdomnioplasty incision was treated with the embrace device.
141967|NCT01399099|E1|Reported Event|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
141968|NCT01399047|B3|Baseline|Total|Total of all reporting groups
141969|NCT01399047|B2|Baseline|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
141970|NCT01399047|B1|Baseline|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
141971|NCT01399047|P2|Participant Flow|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
141972|NCT01399047|P1|Participant Flow|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
141973|NCT01399047|O2|Outcome|Placebo|Includes data from all subjects while on placebo, regardless of treatment order.
141974|NCT01399047|O1|Outcome|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of treatment order.
141975|NCT01399047|E2|Reported Event|Placebo|Includes data from all subjects while on placebo, regardless of order.
141976|NCT01399047|E1|Reported Event|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of order.
141977|NCT01399008|B4|Baseline|Total|Total of all reporting groups
141978|NCT01399008|B3|Baseline|Placebo|Placebo plus Allopurinol 300 mg
141979|NCT01399008|B2|Baseline|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
141980|NCT01399008|B1|Baseline|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
141981|NCT01399008|P3|Participant Flow|Placebo|Placebo plus Allopurinol 300 mg
141982|NCT01399008|P2|Participant Flow|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
141983|NCT01399008|P1|Participant Flow|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
141984|NCT01399008|O3|Outcome|Placebo|Placebo plus Allopurinol 300 mg
141985|NCT01399008|O2|Outcome|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
141986|NCT01399008|O1|Outcome|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
141987|NCT01399008|E3|Reported Event|Placebo Plus Allopurinol 300 mg|Placebo plus allopurinol 300 mg (Safety Population)
141988|NCT01399008|E2|Reported Event|Arhalofenate 600 mg Plus Allopurinol 300 mg|Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)
141989|NCT01399008|E1|Reported Event|Arhalofenate 400 mg Plus Allopurinol 300 mg|Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)
141990|NCT01398982|B3|Baseline|Total|Total of all reporting groups
141991|NCT01398982|B2|Baseline|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141992|NCT01398982|B1|Baseline|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141993|NCT01398982|P2|Participant Flow|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141994|NCT01398982|P1|Participant Flow|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141995|NCT01398982|O2|Outcome|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141996|NCT01398982|O1|Outcome|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141997|NCT01398982|E2|Reported Event|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141998|NCT01398982|E1|Reported Event|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
141999|NCT01398852|B1|Baseline|CXL Treatment|All eyes to be treated with riboflavin and UV light
142000|NCT01398852|P1|Participant Flow|CXL Treatment|All eyes to be treated with riboflavin and UV light
142001|NCT01398852|O1|Outcome|CXL Treatment|All eyes to be treated with riboflavin and UV light
142002|NCT01398852|E1|Reported Event|CXL Treatment|All eyes to be treated with riboflavin and UV light
142003|NCT01398839|B3|Baseline|Total|Total of all reporting groups
142004|NCT01398839|B2|Baseline|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
142005|NCT01398839|B1|Baseline|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
142006|NCT01398839|P2|Participant Flow|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
142007|NCT01398839|P1|Participant Flow|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
142008|NCT01398839|O2|Outcome|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
142009|NCT01398839|O1|Outcome|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
142010|NCT01398839|E2|Reported Event|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
142011|NCT01398839|E1|Reported Event|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
142012|NCT01398787|B1|Baseline|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
142013|NCT01398787|P1|Participant Flow|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
142014|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142015|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142016|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142017|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142018|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142019|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142020|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142021|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142022|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142023|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142024|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
142025|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
142026|NCT01398787|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
155094|NCT01344460|O2|Outcome|Unenhanced MRA|
142027|NCT01398787|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each
142028|NCT01398514|B3|Baseline|Total|Total of all reporting groups
142029|NCT01398514|B2|Baseline|Placebo|Matched pill placebo
142030|NCT01398514|B1|Baseline|Active Medication|Escitalopram 10mg/day
142031|NCT01398514|P2|Participant Flow|Placebo|Matched pill placebo
142032|NCT01398514|P1|Participant Flow|Active Medication|Escitalopram 10mg/day
142033|NCT01398514|O4|Outcome|Placebo CS+|
142034|NCT01398514|O3|Outcome|Placebo CS-|
142035|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
142036|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
142037|NCT01398514|O4|Outcome|Placebo CS+|
142038|NCT01398514|O3|Outcome|Placebo CS-|
142039|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
142040|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
142041|NCT01398514|E2|Reported Event|Placebo|Matched pill placebo
142042|NCT01398514|E1|Reported Event|Active Medication|Escitalopram 10mg/day
142043|NCT01398410|B3|Baseline|Total|Total of all reporting groups
142044|NCT01398410|B2|Baseline|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
142045|NCT01398410|B1|Baseline|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
142046|NCT01398410|P2|Participant Flow|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
142047|NCT01398410|P1|Participant Flow|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
142048|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
142049|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
142050|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
142051|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
142052|NCT01398410|E2|Reported Event|Rabeprazole10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
142053|NCT01398410|E1|Reported Event|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
142054|NCT01398176|B3|Baseline|Total|Total of all reporting groups
142055|NCT01398176|B2|Baseline|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
142056|NCT01398176|B1|Baseline|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
142057|NCT01398176|P2|Participant Flow|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
142058|NCT01398176|P1|Participant Flow|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
142059|NCT01398176|O2|Outcome|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
142060|NCT01398176|O1|Outcome|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
142061|NCT01398176|E2|Reported Event|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
142062|NCT01398176|E1|Reported Event|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
142063|NCT01397890|B3|Baseline|Total|Total of all reporting groups
142064|NCT01397890|B2|Baseline|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142065|NCT01397890|B1|Baseline|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142066|NCT01397890|P2|Participant Flow|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142067|NCT01397890|P1|Participant Flow|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142068|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142069|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142070|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142071|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142072|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142073|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142074|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142075|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142076|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142077|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142078|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142079|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142080|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142218|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142081|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142082|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142083|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142084|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142085|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142086|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142087|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142088|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142089|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142090|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142091|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142092|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142093|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142094|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142095|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142096|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142097|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142098|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142099|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142100|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142101|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142102|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142103|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142104|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142105|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142106|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142107|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142108|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142109|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142110|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142111|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142112|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142113|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142114|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142115|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142116|NCT01397890|E2|Reported Event|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
142117|NCT01397890|E1|Reported Event|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
142118|NCT01397851|B3|Baseline|Total|Total of all reporting groups
142119|NCT01397851|B2|Baseline|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142120|NCT01397851|B1|Baseline|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142121|NCT01397851|P2|Participant Flow|Treatment|
142122|NCT01397851|P1|Participant Flow|Control|
142123|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142511|NCT01396265|P1|Participant Flow|Overall Group|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
155095|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
142124|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142125|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142126|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142127|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142128|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142129|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142130|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142131|NCT01397851|E2|Reported Event|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
142132|NCT01397851|E1|Reported Event|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
142133|NCT01397747|B1|Baseline|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
142134|NCT01397747|P1|Participant Flow|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
142135|NCT01397747|O2|Outcome|FIT Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
142136|NCT01397747|O1|Outcome|Multitarget DNA Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
142137|NCT01397747|E1|Reported Event|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
142138|NCT01397617|B4|Baseline|Total|Total of all reporting groups
142139|NCT01397617|B3|Baseline|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
142140|NCT01397617|B2|Baseline|NobelActive External|"NobelActive External implant~NobelActive External implant"
142141|NCT01397617|B1|Baseline|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
142142|NCT01397617|P3|Participant Flow|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
142143|NCT01397617|P2|Participant Flow|NobelActive External|"NobelActive External implant~NobelActive External implant"
142144|NCT01397617|P1|Participant Flow|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
142145|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant: Dental implant"
142146|NCT01397617|O2|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant: Dental implant"
142147|NCT01397617|O1|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant: Dental implant"
142148|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
142149|NCT01397617|O2|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
142150|NCT01397617|O1|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant"
142151|NCT01397617|E3|Reported Event|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
142152|NCT01397617|E2|Reported Event|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
142153|NCT01397617|E1|Reported Event|NobelActive External|"NobelActive External implant~NobelActive External implant"
142154|NCT01397591|B1|Baseline|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
142181|NCT01397448|P1|Participant Flow|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142568|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142155|NCT01397591|P1|Participant Flow|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
142156|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
142157|NCT01397591|O1|Outcome|Ofatumumab in Combination With Bortezomib|"All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
142158|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
142159|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
142160|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
142161|NCT01397591|E1|Reported Event|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
142162|NCT01397461|B4|Baseline|Total|Total of all reporting groups
142163|NCT01397461|B3|Baseline|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
142164|NCT01397461|B2|Baseline|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
142165|NCT01397461|B1|Baseline|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
142166|NCT01397461|P3|Participant Flow|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
142167|NCT01397461|P2|Participant Flow|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
142168|NCT01397461|P1|Participant Flow|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
142169|NCT01397461|O3|Outcome|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
142170|NCT01397461|O2|Outcome|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
142171|NCT01397461|O1|Outcome|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
142172|NCT01397461|E3|Reported Event|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
142173|NCT01397461|E2|Reported Event|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
142174|NCT01397461|E1|Reported Event|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
142175|NCT01397448|B4|Baseline|Total|Total of all reporting groups
142176|NCT01397448|B3|Baseline|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
142177|NCT01397448|B2|Baseline|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142178|NCT01397448|B1|Baseline|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142179|NCT01397448|P3|Participant Flow|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
142180|NCT01397448|P2|Participant Flow|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142182|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
142183|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142184|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142185|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
142186|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142187|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142188|NCT01397448|E3|Reported Event|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
142189|NCT01397448|E2|Reported Event|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142190|NCT01397448|E1|Reported Event|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
142191|NCT01397409|B11|Baseline|Total|Total of all reporting groups
142192|NCT01397409|B10|Baseline|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
142193|NCT01397409|B9|Baseline|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142194|NCT01397409|B8|Baseline|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142195|NCT01397409|B7|Baseline|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142196|NCT01397409|B6|Baseline|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142197|NCT01397409|B5|Baseline|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142198|NCT01397409|B4|Baseline|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
142199|NCT01397409|B3|Baseline|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
142200|NCT01397409|B2|Baseline|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
142201|NCT01397409|B1|Baseline|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
142202|NCT01397409|P10|Participant Flow|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
142203|NCT01397409|P9|Participant Flow|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142204|NCT01397409|P8|Participant Flow|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142205|NCT01397409|P7|Participant Flow|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142206|NCT01397409|P6|Participant Flow|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142207|NCT01397409|P5|Participant Flow|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142208|NCT01397409|P4|Participant Flow|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
142209|NCT01397409|P3|Participant Flow|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
142210|NCT01397409|P2|Participant Flow|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
142211|NCT01397409|P1|Participant Flow|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
142212|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
142213|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
142214|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142215|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
142216|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
142217|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142569|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142219|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142220|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142221|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142222|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142223|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142224|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142225|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142226|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142227|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
142228|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
142229|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142230|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142231|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142232|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142233|NCT01397409|O4|Outcome|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
142234|NCT01397409|O3|Outcome|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
142235|NCT01397409|O2|Outcome|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
142236|NCT01397409|O1|Outcome|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
142237|NCT01397409|O1|Outcome|Stage 1 All Participants|Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
142238|NCT01397409|E10|Reported Event|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
142239|NCT01397409|E9|Reported Event|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142240|NCT01397409|E8|Reported Event|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
142241|NCT01397409|E7|Reported Event|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142242|NCT01397409|E6|Reported Event|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142243|NCT01397409|E5|Reported Event|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
142244|NCT01397409|E4|Reported Event|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
142245|NCT01397409|E3|Reported Event|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
142246|NCT01397409|E2|Reported Event|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
142247|NCT01397409|E1|Reported Event|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
142248|NCT01397253|B3|Baseline|Total|Total of all reporting groups
142249|NCT01397253|B2|Baseline|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
142250|NCT01397253|B1|Baseline|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
142274|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142570|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142251|NCT01397253|P2|Participant Flow|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
142252|NCT01397253|P1|Participant Flow|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
142253|NCT01397253|O2|Outcome|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
142254|NCT01397253|O1|Outcome|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
142255|NCT01397253|E2|Reported Event|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
142256|NCT01397253|E1|Reported Event|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
142257|NCT01397084|B1|Baseline|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
142258|NCT01397084|P1|Participant Flow|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
142259|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
142260|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
142261|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
142262|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
142263|NCT01397084|E1|Reported Event|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
142264|NCT01396525|B1|Baseline|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142265|NCT01396525|P1|Participant Flow|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142266|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142267|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142268|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142269|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142270|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142271|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142272|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142273|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142400|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142275|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142276|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142277|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142278|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142279|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142280|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142281|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142282|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142283|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142284|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142285|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142286|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142287|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142288|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142289|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142290|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142291|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142292|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142293|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142294|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142295|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142571|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142296|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142297|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142298|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142299|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142300|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142301|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142302|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142303|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142304|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142305|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142306|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142307|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142308|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142309|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142310|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142311|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142312|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142313|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142314|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142315|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142316|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142572|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142317|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142318|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142319|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142320|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142321|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142322|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142323|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142324|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142325|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142326|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142327|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142328|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142329|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142330|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142331|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142332|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142333|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142334|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142335|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142336|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142337|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142338|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
155096|NCT01344460|O3|Outcome|Computed Tomographic Angiography|
142339|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142340|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142341|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142342|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142343|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142344|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142345|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142346|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142347|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142348|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142349|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142350|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142351|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142352|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142353|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142354|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142355|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142356|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142357|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142358|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142359|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142360|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142361|NCT01396525|E1|Reported Event|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
142362|NCT01396512|B3|Baseline|Total|Total of all reporting groups
142363|NCT01396512|B2|Baseline|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142364|NCT01396512|B1|Baseline|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142365|NCT01396512|P2|Participant Flow|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142366|NCT01396512|P1|Participant Flow|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142367|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142368|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142369|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142370|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142371|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142372|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142373|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142374|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142375|NCT01396512|E2|Reported Event|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
142376|NCT01396512|E1|Reported Event|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
142377|NCT01396434|B4|Baseline|Total|Total of all reporting groups
142378|NCT01396434|B3|Baseline|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
142379|NCT01396434|B2|Baseline|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
142380|NCT01396434|B1|Baseline|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
142381|NCT01396434|P3|Participant Flow|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
142382|NCT01396434|P2|Participant Flow|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
142383|NCT01396434|P1|Participant Flow|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
142384|NCT01396434|O3|Outcome|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
142385|NCT01396434|O2|Outcome|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
142386|NCT01396434|O1|Outcome|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
142387|NCT01396434|E3|Reported Event|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
142388|NCT01396434|E2|Reported Event|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
142389|NCT01396434|E1|Reported Event|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
142390|NCT01396421|B5|Baseline|Total|Total of all reporting groups
142391|NCT01396421|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
142392|NCT01396421|B3|Baseline|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142393|NCT01396421|B2|Baseline|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142394|NCT01396421|B1|Baseline|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142395|NCT01396421|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
142396|NCT01396421|P3|Participant Flow|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142397|NCT01396421|P2|Participant Flow|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142398|NCT01396421|P1|Participant Flow|Brexpiprazole 4 mg|"Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142399|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142401|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142402|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142403|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks
142404|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142405|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142406|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142407|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142408|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142409|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142410|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142411|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142412|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142413|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142414|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142415|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142416|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142417|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142418|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142419|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142420|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142421|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142422|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142423|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142424|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142425|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day by Day 5."
142426|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142427|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142428|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142429|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142430|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142431|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142432|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142433|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142508|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
142434|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2"
142435|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142436|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142437|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142438|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142439|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142440|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142441|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142442|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142443|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142444|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142445|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a r5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142446|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142447|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142448|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142449|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142450|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142451|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142452|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142453|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5)."
142454|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142455|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142456|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142457|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142458|NCT01396421|O1|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142459|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
142460|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks
142461|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142462|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142463|NCT01396421|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
142464|NCT01396421|E3|Reported Event|Brexpiprazile 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
142465|NCT01396421|E2|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
142466|NCT01396421|E1|Reported Event|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
142467|NCT01396395|B3|Baseline|Total|Total of all reporting groups
142468|NCT01396395|B2|Baseline|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142469|NCT01396395|B1|Baseline|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142470|NCT01396395|P2|Participant Flow|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142471|NCT01396395|P1|Participant Flow|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.
142472|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142473|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142474|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142475|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142476|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142477|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142478|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142479|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142480|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142481|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142482|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142483|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142484|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142485|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142486|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142509|NCT01396382|E1|Reported Event|68Ga-DOTATATE PET Scan|Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
142487|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142488|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142489|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142490|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142491|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142492|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142493|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142494|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142495|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142496|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142497|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142498|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142499|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142500|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142501|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142502|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142503|NCT01396395|E2|Reported Event|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
142504|NCT01396395|E1|Reported Event|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
142505|NCT01396382|B1|Baseline|Imaging/Scans|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
142506|NCT01396382|P1|Participant Flow|68Ga-DOTATATE PET Scan|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
142507|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
142512|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142513|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142514|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142515|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142516|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142517|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142518|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142519|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142520|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142521|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142522|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142523|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142524|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142525|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142526|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142527|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142528|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142529|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142530|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142531|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142532|NCT01396265|E2|Reported Event|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
142533|NCT01396265|E1|Reported Event|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
142534|NCT01396239|B4|Baseline|Total|Total of all reporting groups
142535|NCT01396239|B3|Baseline|Placebo|Placebo: phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks
142536|NCT01396239|B2|Baseline|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
142537|NCT01396239|B1|Baseline|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
142538|NCT01396239|P4|Participant Flow|Placebo - Week 24 Biopsy|Placebo for 24 weeks with muscle biopsy at Week 24
142539|NCT01396239|P3|Participant Flow|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
142540|NCT01396239|P2|Participant Flow|Placebo - Week 12 Biopsy|Placebo for 24 Weeks with muscle Biopsy at Week 12
142541|NCT01396239|P1|Participant Flow|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
142542|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
142543|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
142544|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
142545|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
142546|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
142547|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
142548|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
142549|NCT01396239|O2|Outcome|50mg/kg Eteplirsen|50mg/kg eteplirsen for 24 weeks
142550|NCT01396239|O1|Outcome|30mg/kg Eteplirsen|30mg/kg eteplirsen for 24 weeks
142551|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
142552|NCT01396239|O2|Outcome|50 mg/kg Eteplirsen|50 mg/kg eteplirsen for 24 weeks
142553|NCT01396239|O1|Outcome|30 mg/kg Eteplirsen|30 mg/kg eteplirsen for 24 weeks
142554|NCT01396239|O4|Outcome|Placebo - Week 12 Biopsy|Placebo - Biopsied after 12 weeks of dosing
142555|NCT01396239|O3|Outcome|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen - Biopsied after 12 weeks of dosing
142556|NCT01396239|O2|Outcome|Placebo - Week 24 Biopsy|Placebo: Biopsied after 24 weeks of dosing
142557|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen - Biopsied after 24 weeks of dosing
142558|NCT01396239|E3|Reported Event|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
142559|NCT01396239|E2|Reported Event|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
142560|NCT01396239|E1|Reported Event|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
142561|NCT01396226|B3|Baseline|Total|Total of all reporting groups
142562|NCT01396226|B2|Baseline|PLACEBO|Placebo solution for infusion
142563|NCT01396226|B1|Baseline|AZD2927|AZD2927 solution for infusion
142564|NCT01396226|P2|Participant Flow|PLACEBO|Placebo solution for infusion
142565|NCT01396226|P1|Participant Flow|AZD2927|AZD2927 solution for infusion
142566|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142567|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142575|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142576|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142577|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142578|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142579|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142580|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142581|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142582|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142583|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142584|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142585|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142586|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142587|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142588|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142589|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142590|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
142591|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
142592|NCT01396226|E2|Reported Event|PLACEBO|Placebo solution for infusion
142593|NCT01396226|E1|Reported Event|AZD2927|AZD2927 solution for infusion
142594|NCT01396187|B6|Baseline|Total|Total of all reporting groups
142595|NCT01396187|B5|Baseline|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142596|NCT01396187|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142597|NCT01396187|B3|Baseline|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142598|NCT01396187|B2|Baseline|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142599|NCT01396187|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142600|NCT01396187|P5|Participant Flow|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142601|NCT01396187|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142602|NCT01396187|P3|Participant Flow|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142603|NCT01396187|P2|Participant Flow|PF-05231023 5 mg|PF-05231023 5 mg (milligram) intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142604|NCT01396187|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142605|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142606|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142607|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142608|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142609|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142610|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142611|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142612|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142613|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142614|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142615|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142616|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142617|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142618|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142619|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142620|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142621|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142622|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142623|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142624|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142625|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
155097|NCT01344460|O2|Outcome|Unenhanced MRA|
142626|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142627|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142628|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142629|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142630|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142631|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142632|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142633|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142634|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142635|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142636|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142637|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142638|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142639|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142640|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142641|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142642|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142643|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142644|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142645|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142646|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142647|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142648|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142649|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142650|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142651|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142652|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142653|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142654|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142655|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142656|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142657|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142658|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142659|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142660|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142661|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142662|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142663|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142664|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142665|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142666|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142667|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142668|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142669|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142670|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142671|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142672|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142673|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142674|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142675|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142676|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142677|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142678|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142679|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142680|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142681|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142682|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142683|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142684|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142685|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142686|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142687|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142688|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142689|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142690|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142691|NCT01396187|E5|Reported Event|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142692|NCT01396187|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142693|NCT01396187|E3|Reported Event|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
142694|NCT01396187|E2|Reported Event|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142695|NCT01396187|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
142696|NCT01396161|B8|Baseline|Total|Total of all reporting groups
142697|NCT01396161|B7|Baseline|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142698|NCT01396161|B6|Baseline|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142699|NCT01396161|B5|Baseline|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
142700|NCT01396161|B4|Baseline|PF-05175157 100 mg QD -HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142701|NCT01396161|B3|Baseline|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142702|NCT01396161|B2|Baseline|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
142703|NCT01396161|B1|Baseline|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
142704|NCT01396161|P7|Participant Flow|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142705|NCT01396161|P6|Participant Flow|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
142706|NCT01396161|P5|Participant Flow|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142707|NCT01396161|P4|Participant Flow|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142708|NCT01396161|P3|Participant Flow|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
142709|NCT01396161|P2|Participant Flow|Placebo - Type 2 Diabetes Mellitus Participants (T2DM)|T2DM participants administered orally matched placebo capsules QD for 14 days
142710|NCT01396161|P1|Participant Flow|Placebo - Healthy and Overweight Participants (HOV)|HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
142711|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142712|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142713|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142714|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142715|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142716|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142717|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142718|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142719|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142720|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142721|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
142722|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
142723|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142724|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142725|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142726|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142727|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142728|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142729|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142730|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142731|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142732|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142733|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142734|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142735|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142736|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142737|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142738|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142739|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142740|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142741|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142742|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142743|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142744|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142745|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142746|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142747|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142748|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142749|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142750|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142751|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142752|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142753|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
142754|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
142755|NCT01396161|E7|Reported Event|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142756|NCT01396161|E6|Reported Event|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
142757|NCT01396161|E5|Reported Event|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
142758|NCT01396161|E4|Reported Event|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
142759|NCT01396161|E3|Reported Event|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
142760|NCT01396161|E2|Reported Event|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
142761|NCT01396161|E1|Reported Event|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
142762|NCT01396083|B3|Baseline|Total|Total of all reporting groups
142763|NCT01396083|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142764|NCT01396083|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142929|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142765|NCT01396083|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142766|NCT01396083|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142767|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142768|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142769|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142770|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142771|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142772|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142773|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142774|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142775|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142776|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142777|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142778|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142779|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142780|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142781|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142782|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142783|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142784|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142785|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142786|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142787|NCT01396083|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142788|NCT01396083|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142789|NCT01396057|B3|Baseline|Total|Total of all reporting groups
142790|NCT01396057|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142791|NCT01396057|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142792|NCT01396057|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142793|NCT01396057|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142794|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142795|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142796|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142797|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142798|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142799|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142800|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142801|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142802|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142803|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142804|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142805|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142806|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142807|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142808|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142809|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142810|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142811|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142812|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142813|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142930|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142814|NCT01396057|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
142815|NCT01396057|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
142816|NCT01396044|B3|Baseline|Total|Total of all reporting groups
142817|NCT01396044|B2|Baseline|Verbal Prompting|Verbal prompting with written checklist
142818|NCT01396044|B1|Baseline|Electronic Checklist|Electronic checklist
142819|NCT01396044|P2|Participant Flow|Verbal Prompting|Verbal prompting with written checklist
142820|NCT01396044|P1|Participant Flow|Electronic Checklist|Electronic checklist
142821|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142822|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142823|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142824|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142825|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142826|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142827|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142828|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142829|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142830|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142831|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142832|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142833|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142834|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142835|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
142836|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
142837|NCT01396044|E2|Reported Event|Verbal Prompting|Verbal prompting with written checklist
142838|NCT01396044|E1|Reported Event|Electronic Checklist|Electronic checklist
142839|NCT01396005|B3|Baseline|Total|Total of all reporting groups
142840|NCT01396005|B2|Baseline|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142841|NCT01396005|B1|Baseline|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142842|NCT01396005|P2|Participant Flow|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142843|NCT01396005|P1|Participant Flow|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142844|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142845|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142846|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142847|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142848|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142849|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142850|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142851|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142852|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142853|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142854|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142855|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142931|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
142856|NCT01396005|E2|Reported Event|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
142857|NCT01396005|E1|Reported Event|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
142858|NCT01395966|B4|Baseline|Total|Total of all reporting groups
142859|NCT01395966|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
142860|NCT01395966|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
142861|NCT01395966|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
142862|NCT01395966|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
142863|NCT01395966|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
142864|NCT01395966|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
142865|NCT01395966|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
142866|NCT01395966|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
142867|NCT01395966|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
142868|NCT01395966|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
142869|NCT01395966|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
142870|NCT01395966|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
142871|NCT01395901|B3|Baseline|Total|Total of all reporting groups
142872|NCT01395901|B2|Baseline|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142873|NCT01395901|B1|Baseline|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142874|NCT01395901|P2|Participant Flow|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142875|NCT01395901|P1|Participant Flow|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142876|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142877|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142878|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142879|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142880|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142881|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142882|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142883|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142884|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142885|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142886|NCT01395901|E2|Reported Event|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
142887|NCT01395901|E1|Reported Event|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
142888|NCT01395888|B3|Baseline|Total|Total of all reporting groups
142889|NCT01395888|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
142890|NCT01395888|B1|Baseline|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
142932|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142933|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142934|NCT01395524|E3|Reported Event|Placebo|
142891|NCT01395888|P3|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
142892|NCT01395888|P2|Participant Flow|FF/VI 100/25 µg|Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
142893|NCT01395888|P1|Participant Flow|Salb/Alb + IBr|Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
142894|NCT01395888|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
142895|NCT01395888|O1|Outcome|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
142896|NCT01395888|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
142897|NCT01395888|E1|Reported Event|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
142898|NCT01395823|B3|Baseline|Total|Total of all reporting groups
142899|NCT01395823|B2|Baseline|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
142900|NCT01395823|B1|Baseline|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
142901|NCT01395823|P2|Participant Flow|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
142902|NCT01395823|P1|Participant Flow|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
142903|NCT01395823|O2|Outcome|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
142904|NCT01395823|O1|Outcome|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
142905|NCT01395823|E2|Reported Event|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
142906|NCT01395823|E1|Reported Event|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
142907|NCT01395784|B1|Baseline|Withing-subjects, Placebo-Controlled|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
142908|NCT01395784|P1|Participant Flow|Withing-subjects, Placebo-Controlled|"Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.~pioglitazone: A PPARγ agonist, also marketed as Actos."
142909|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
142910|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
142911|NCT01395784|E1|Reported Event|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
142912|NCT01395524|B4|Baseline|Total|Total of all reporting groups
142913|NCT01395524|B3|Baseline|Placebo|Placebo QD, oral treatment
142914|NCT01395524|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142915|NCT01395524|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142916|NCT01395524|P3|Participant Flow|Placebo|Placebo QD, oral treatment
142917|NCT01395524|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142918|NCT01395524|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142919|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
142920|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142921|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142922|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
142923|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142924|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142925|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
142926|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
142927|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
142928|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
142938|NCT01395394|B3|Baseline|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142939|NCT01395394|B2|Baseline|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142940|NCT01395394|B1|Baseline|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142941|NCT01395394|P3|Participant Flow|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142942|NCT01395394|P2|Participant Flow|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142943|NCT01395394|P1|Participant Flow|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142944|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142945|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142946|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142947|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142948|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142949|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142950|NCT01395394|E3|Reported Event|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142951|NCT01395394|E2|Reported Event|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142995|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142996|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143257|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
142952|NCT01395394|E1|Reported Event|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
142953|NCT01395368|B1|Baseline|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
142954|NCT01395368|P1|Participant Flow|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
142955|NCT01395368|O1|Outcome|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
142956|NCT01395368|E1|Reported Event|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
142957|NCT01395277|B3|Baseline|Total|Total of all reporting groups
142958|NCT01395277|B2|Baseline|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
142959|NCT01395277|B1|Baseline|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
142960|NCT01395277|P2|Participant Flow|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
142961|NCT01395277|P1|Participant Flow|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
142962|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142963|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142997|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142998|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
142999|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
143000|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143001|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142964|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142965|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142966|NCT01395277|E2|Reported Event|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142967|NCT01395277|E1|Reported Event|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
142968|NCT01395043|B1|Baseline|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
142969|NCT01395043|P1|Participant Flow|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
142970|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters.
142971|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2,5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
142972|NCT01395043|E1|Reported Event|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
142973|NCT01395017|B3|Baseline|Total|Total of all reporting groups
142974|NCT01395017|B2|Baseline|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
142975|NCT01395017|B1|Baseline|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
142976|NCT01395017|P2|Participant Flow|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
142977|NCT01395017|P1|Participant Flow|Dasatinib + GEM|GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
142978|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
142979|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
142980|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
142981|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
142982|NCT01395017|E2|Reported Event|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
142983|NCT01395017|E1|Reported Event|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
142984|NCT01394991|B3|Baseline|Total|Total of all reporting groups
142985|NCT01394991|B2|Baseline|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142986|NCT01394991|B1|Baseline|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
142987|NCT01394991|P2|Participant Flow|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142988|NCT01394991|P1|Participant Flow|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
142989|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142990|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
142991|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142992|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
142993|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
142994|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143002|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143003|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
143004|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143005|NCT01394991|E2|Reported Event|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
143006|NCT01394991|E1|Reported Event|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
143007|NCT01394926|B1|Baseline|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
143008|NCT01394926|P1|Participant Flow|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
143009|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
143010|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL Optison at Time 6.5 Minutes|Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.
143011|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1: Injection of 0.15mL Optison at time 0.
143012|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
143013|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes|Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.
143014|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.
143015|NCT01394926|E1|Reported Event|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
143016|NCT01394718|B3|Baseline|Total|Total of all reporting groups
143017|NCT01394718|B2|Baseline|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143018|NCT01394718|B1|Baseline|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143019|NCT01394718|P2|Participant Flow|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143020|NCT01394718|P1|Participant Flow|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143021|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143022|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143023|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143024|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143025|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143026|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143153|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143027|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143028|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143029|NCT01394718|E2|Reported Event|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
143030|NCT01394718|E1|Reported Event|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
143031|NCT01394692|B3|Baseline|Total|Total of all reporting groups
143032|NCT01394692|B2|Baseline|Conventional Group|standard microsurgical tumor resection
143033|NCT01394692|B1|Baseline|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
143034|NCT01394692|P2|Participant Flow|Conventional Group|standard microsurgical tumor resection
143035|NCT01394692|P1|Participant Flow|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
143036|NCT01394692|O2|Outcome|Conventional Group|standard microsurgical tumor resection
143037|NCT01394692|O1|Outcome|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
143038|NCT01394692|E2|Reported Event|Conventional Group|standard microsurgical tumor resection
143039|NCT01394692|E1|Reported Event|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
143040|NCT01394614|B3|Baseline|Total|Total of all reporting groups
143041|NCT01394614|B2|Baseline|Unexposed Narcoleptic Subjects|Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
143042|NCT01394614|B1|Baseline|Exposed Narcoleptic Subjects|Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
143043|NCT01394614|P2|Participant Flow|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
143044|NCT01394614|P1|Participant Flow|Narcoleptic Subjects Exposed to Vaccine|Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
143045|NCT01394614|O2|Outcome|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
143046|NCT01394614|O1|Outcome|Exposed Narcoleptic Subjects|"Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix."
143047|NCT01394614|E2|Reported Event|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
143048|NCT01394614|E1|Reported Event|Exposed Narcoleptic Subjects|"Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)"
143049|NCT01394510|B1|Baseline|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143050|NCT01394510|P1|Participant Flow|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143051|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143052|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143053|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143054|NCT01394510|E1|Reported Event|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
143154|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143155|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143055|NCT01394276|B1|Baseline|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143056|NCT01394276|P1|Participant Flow|Tocilizumab|Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
143057|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143058|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143059|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143060|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143061|NCT01394276|O2|Outcome|DMARD + Anti-TNF-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143062|NCT01394276|O1|Outcome|DMARD-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143063|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143064|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents. Participants receiving treatment with TCZ with dose of 8 milligrams mg/kg body weight, intravenously once every 4 weeks for 12 months were observed. Dosage of TCZ was prescribed according to EU approved dosage, and SmPC.
143065|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143066|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143067|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143068|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143069|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143070|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143071|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143072|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143156|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143073|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143074|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143075|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143076|NCT01394276|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
143077|NCT01394250|B3|Baseline|Total|Total of all reporting groups
143078|NCT01394250|B2|Baseline|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
143079|NCT01394250|B1|Baseline|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
143080|NCT01394250|P2|Participant Flow|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
143081|NCT01394250|P1|Participant Flow|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
143082|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
143083|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
143084|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
143085|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
143086|NCT01394250|E2|Reported Event|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
143087|NCT01394250|E1|Reported Event|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
143088|NCT01394159|B3|Baseline|Total|Total of all reporting groups
143089|NCT01394159|B2|Baseline|FNA Needle|FNA: Acquire tissue with FNA needle
143090|NCT01394159|B1|Baseline|ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143091|NCT01394159|P2|Participant Flow|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
143092|NCT01394159|P1|Participant Flow|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143093|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
143094|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143095|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
143096|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143097|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
143098|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143099|NCT01394159|E2|Reported Event|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
143100|NCT01394159|E1|Reported Event|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
143101|NCT01393964|B4|Baseline|Total|Total of all reporting groups
143102|NCT01393964|B3|Baseline|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143103|NCT01393964|B2|Baseline|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143104|NCT01393964|B1|Baseline|Elotuzumab + LD in Normal Renal Function (NRF) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143157|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143158|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143105|NCT01393964|P3|Participant Flow|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
143106|NCT01393964|P2|Participant Flow|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis.
143107|NCT01393964|P1|Participant Flow|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
143108|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143109|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143110|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143111|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143112|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143159|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143160|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
155098|NCT01344460|O1|Outcome|Gadobutrol-Enhanced MRA|
143113|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143114|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143115|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143116|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143117|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143118|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143119|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143120|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143161|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143162|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143121|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143122|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143123|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143124|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143125|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143126|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143127|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143128|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143163|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143164|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143129|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143130|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143131|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143132|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143133|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143134|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143135|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
143136|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143165|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143166|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143167|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143168|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143137|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143138|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialyis.
143139|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
143140|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
143141|NCT01393964|E3|Reported Event|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
143142|NCT01393964|E2|Reported Event|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis
143143|NCT01393964|E1|Reported Event|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
143144|NCT01393899|B4|Baseline|Total|Total of all reporting groups
143145|NCT01393899|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143146|NCT01393899|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143147|NCT01393899|B1|Baseline|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143148|NCT01393899|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143149|NCT01393899|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143150|NCT01393899|P1|Participant Flow|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143151|NCT01393899|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143152|NCT01393899|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
155099|NCT01344460|O1|Outcome|Computed Tomographic Angiography (CTA)|
143169|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143170|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143171|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143172|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143173|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143174|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143175|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143176|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143177|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143178|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143179|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143180|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143181|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143182|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143183|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143184|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143185|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143186|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143187|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143188|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143189|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143190|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143191|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143192|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143193|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143194|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143195|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143196|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143197|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143198|NCT01393899|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
143199|NCT01393899|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
143200|NCT01393899|E1|Reported Event|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
143201|NCT01393743|B3|Baseline|Total|Total of all reporting groups
143202|NCT01393743|B2|Baseline|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143203|NCT01393743|B1|Baseline|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143204|NCT01393743|P2|Participant Flow|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143205|NCT01393743|P1|Participant Flow|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143206|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143207|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143208|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143256|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143209|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143210|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143211|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143212|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143213|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143214|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143215|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143216|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143217|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143218|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143219|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143220|NCT01393743|E2|Reported Event|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
143221|NCT01393743|E1|Reported Event|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
143222|NCT01393613|B5|Baseline|Total|Total of all reporting groups
143223|NCT01393613|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
143224|NCT01393613|B3|Baseline|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143225|NCT01393613|B2|Baseline|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143226|NCT01393613|B1|Baseline|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143227|NCT01393613|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
143228|NCT01393613|P3|Participant Flow|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143229|NCT01393613|P2|Participant Flow|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143230|NCT01393613|P1|Participant Flow|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143231|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143232|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143233|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143234|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143235|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
143236|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
143237|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143238|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143239|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143240|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143241|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143242|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143243|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143244|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143245|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143246|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143247|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143248|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143249|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143250|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143251|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143252|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143253|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143254|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143255|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143258|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143259|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143260|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143261|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143262|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143263|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143264|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143265|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143266|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143267|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143268|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143269|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143270|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143271|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143272|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143273|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143274|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143275|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143276|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143277|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143278|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143279|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143280|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143281|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143282|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143283|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
143284|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143285|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143286|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143287|NCT01393613|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
143288|NCT01393613|E3|Reported Event|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
143289|NCT01393613|E2|Reported Event|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
143290|NCT01393613|E1|Reported Event|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
143291|NCT01393444|B1|Baseline|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
143292|NCT01393444|P1|Participant Flow|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
143293|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
143294|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
143295|NCT01393444|E1|Reported Event|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
143296|NCT01393132|B3|Baseline|Total|Total of all reporting groups
143297|NCT01393132|B2|Baseline|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143298|NCT01393132|B1|Baseline|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143299|NCT01393132|P2|Participant Flow|Placebo|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days."
143300|NCT01393132|P1|Participant Flow|Thymosin|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.~Period Title * Participant Flow: Overall Study~Placebo Thymosin Beta 4 Started 3 6 Completed 3 6"
143301|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143302|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
144571|NCT01388816|E4|Reported Event|DRL-17822 300 mg|Once daily after breakfast
143303|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143304|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143305|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143306|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
143307|NCT01393132|O2|Outcome|Placebo|Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
143308|NCT01393132|O1|Outcome|Thymosin|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
143309|NCT01393132|E2|Reported Event|Placebo|: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
143310|NCT01393132|E1|Reported Event|Thymosin Beta 4|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
143311|NCT01393106|B1|Baseline|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143312|NCT01393106|P1|Participant Flow|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143313|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143314|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143315|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143316|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143317|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143318|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143319|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143320|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143321|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143322|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143323|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143324|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143325|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143326|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143327|NCT01393106|E1|Reported Event|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
143328|NCT01392742|B1|Baseline|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143329|NCT01392742|P1|Participant Flow|Hepatitis C Virus (HCV) Infected Participants|Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators’ discretion.
143330|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143331|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143332|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143376|NCT01392677|P1|Participant Flow|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143333|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143334|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143335|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143336|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143337|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143338|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143339|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143340|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143341|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
143342|NCT01392742|E1|Reported Event|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately 24 weeks. Dose change was as per investigators’ discretion.
143343|NCT01392703|B1|Baseline|All Treated|
143344|NCT01392703|P3|Participant Flow|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143345|NCT01392703|P2|Participant Flow|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143346|NCT01392703|P1|Participant Flow|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143347|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143348|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143349|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143350|NCT01392703|O1|Outcome|All Treated|
143351|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143352|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143353|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143377|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143860|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143354|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143355|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143356|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143357|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143358|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143359|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143360|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143361|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period..
143362|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143363|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143364|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143365|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143366|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143367|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143368|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143369|NCT01392703|E3|Reported Event|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
143370|NCT01392703|E2|Reported Event|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143371|NCT01392703|E1|Reported Event|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
143372|NCT01392677|B3|Baseline|Total|Total of all reporting groups
143373|NCT01392677|B2|Baseline|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143374|NCT01392677|B1|Baseline|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143375|NCT01392677|P2|Participant Flow|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
155100|NCT01344460|O2|Outcome|Unenhanced MRA|
143378|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143379|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143380|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143381|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143382|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143383|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143384|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143385|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143386|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143387|NCT01392677|E2|Reported Event|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
143388|NCT01392677|E1|Reported Event|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
143389|NCT01392573|B3|Baseline|Total|Total of all reporting groups
143390|NCT01392573|B2|Baseline|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
143391|NCT01392573|B1|Baseline|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
143392|NCT01392573|P2|Participant Flow|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
143393|NCT01392573|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
143394|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
143395|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
143396|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
143397|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
143398|NCT01392573|E2|Reported Event|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
143399|NCT01392573|E1|Reported Event|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
143400|NCT01392560|B1|Baseline|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
143401|NCT01392560|P1|Participant Flow|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
143402|NCT01392560|O3|Outcome|Non-hyperfilterers (Empagliflozin 25 mg)|"Non-hyperfilterers~Empagliflozin 25 mg: Oral once daily~non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2"
143403|NCT01392560|O2|Outcome|Hyperfilterers (Empagliflozin 25 mg)|"Hyperfilterers~Empagliflozin 25 mg: Oral once daily~hyperfilterers = GFRs of ≥135 mL/min/1.73m2"
143404|NCT01392560|O1|Outcome|All Patients (Empagliflozin 25 mg)|"All patients (hyperfilterers and non-hyperfilterers)~Empagliflozin 25 mg: Oral once daily"
143405|NCT01392560|E1|Reported Event|Empagliflozin 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
143406|NCT01392547|B1|Baseline|Vatrepcacog Alfa and rFVIIa|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner.
143407|NCT01392547|P1|Participant Flow|Vatreptacog Alfa and rFVIIa (All Subjects)|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds.
143408|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143409|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143410|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143411|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143412|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143413|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143414|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143415|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143416|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143417|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143418|NCT01392547|E2|Reported Event|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
143419|NCT01392547|E1|Reported Event|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
143420|NCT01392495|B1|Baseline|QTI571|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143421|NCT01392495|P1|Participant Flow|QTI571|Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
143422|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143423|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143424|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143425|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143426|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143427|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143428|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143429|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143430|NCT01392495|E2|Reported Event|QTI571 400mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143431|NCT01392495|E1|Reported Event|QTI571 200mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
143432|NCT01392378|B6|Baseline|Total|Total of all reporting groups
143433|NCT01392378|B5|Baseline|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143434|NCT01392378|B4|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143435|NCT01392378|B3|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143802|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143436|NCT01392378|B2|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143437|NCT01392378|B1|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143438|NCT01392378|P5|Participant Flow|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143439|NCT01392378|P4|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143440|NCT01392378|P3|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143441|NCT01392378|P2|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143442|NCT01392378|P1|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143443|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143444|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143445|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143446|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143447|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143448|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143617|NCT01392326|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
143618|NCT01391559|B1|Baseline|Entire Study Population|Includes groups randomized to receive Arformoterol first and Salmeterol first
143449|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143450|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143451|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143452|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143453|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143454|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143455|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143456|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143457|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143458|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143459|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143460|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143461|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143619|NCT01391559|P2|Participant Flow|Salmeterol First, Then Arformoterol|Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
143858|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143462|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143463|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143464|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143465|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143466|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143467|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143468|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143469|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143470|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143471|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143472|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143473|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143474|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143488|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143475|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143476|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143477|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143478|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143479|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143480|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143481|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143482|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143483|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143484|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143485|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143486|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143487|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143620|NCT01391559|P1|Participant Flow|Arformoterol First, Then Salmeterol|Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
143489|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143490|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143491|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143492|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143493|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143494|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143495|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143496|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143497|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143498|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143499|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143500|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143501|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143621|NCT01391559|O2|Outcome|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
143622|NCT01391559|O1|Outcome|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
143623|NCT01391559|E2|Reported Event|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
143502|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143503|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143504|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143505|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143506|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143507|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143508|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143509|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143510|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143511|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143512|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143513|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143514|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143528|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143515|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143516|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143517|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143518|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143519|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143520|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143521|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143522|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143523|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143524|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143525|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143526|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143527|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143603|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143604|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143605|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143529|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143530|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143531|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143532|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143533|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143534|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143535|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143536|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143537|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143538|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143539|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143540|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143541|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143606|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143607|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143608|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143609|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143542|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143543|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143544|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143545|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143546|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143547|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143548|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143549|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143550|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143551|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143552|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143553|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143554|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143610|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143611|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143612|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143613|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143614|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143555|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143556|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143557|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143558|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
143559|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
143560|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
143561|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
143562|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
143563|NCT01392378|E15|Reported Event|13vPnC + INFANRIX Hexa - Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
143564|NCT01392378|E14|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
143565|NCT01392378|E13|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
143566|NCT01392378|E12|Reported Event|13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
143615|NCT01392326|E3|Reported Event|Placebo|Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
143616|NCT01392326|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
143624|NCT01391559|E1|Reported Event|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
143567|NCT01392378|E11|Reported Event|13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
143568|NCT01392378|E10|Reported Event|13vPnC + INFANRIX Hexa - After Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
143569|NCT01392378|E9|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
143570|NCT01392378|E8|Reported Event|13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
143571|NCT01392378|E7|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
143572|NCT01392378|E6|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
143573|NCT01392378|E5|Reported Event|13vPnC + INFANRIX Hexa - Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
143574|NCT01392378|E4|Reported Event|13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
143575|NCT01392378|E3|Reported Event|13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
143576|NCT01392378|E2|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
143577|NCT01392378|E1|Reported Event|13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
143578|NCT01392326|B4|Baseline|Total|Total of all reporting groups
143579|NCT01392326|B3|Baseline|Group 3|Placebo match (for 75 and 150 mg)
143580|NCT01392326|B2|Baseline|Group 2|Secukinumab (150 mg)
143581|NCT01392326|B1|Baseline|Group 1|Secukinumab (75mg)
143582|NCT01392326|P3|Participant Flow|Placebo Match for AIN457 ( 75 and 150 mg)|Placebo match (for 75 and 150 mg)
143583|NCT01392326|P2|Participant Flow|AIN457 (150 mg)|Secukinumab (150 mg)
143584|NCT01392326|P1|Participant Flow|AIN457 (75 mg)|Secukinumab (75mg)
143585|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143586|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143587|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143588|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143589|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143590|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143591|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143592|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143593|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143594|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143595|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143596|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143597|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143598|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143599|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143600|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
143601|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
143602|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
143626|NCT01391507|B4|Baseline|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143627|NCT01391507|B3|Baseline|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143628|NCT01391507|B2|Baseline|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143629|NCT01391507|B1|Baseline|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143630|NCT01391507|P4|Participant Flow|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143631|NCT01391507|P3|Participant Flow|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143632|NCT01391507|P2|Participant Flow|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143633|NCT01391507|P1|Participant Flow|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143634|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143635|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143636|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143637|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143638|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143639|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143640|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143641|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143642|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143643|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143644|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143645|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143646|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143647|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143648|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143649|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143650|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143651|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143652|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143653|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143654|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143655|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143656|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143657|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143658|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143659|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
155101|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
143660|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143661|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143662|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143663|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143664|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143665|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143666|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143667|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143668|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143669|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143670|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143671|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143672|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143673|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143674|NCT01391507|E4|Reported Event|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143675|NCT01391507|E3|Reported Event|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143676|NCT01391507|E2|Reported Event|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143677|NCT01391507|E1|Reported Event|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
143678|NCT01392300|B3|Baseline|Total|Total of all reporting groups
143679|NCT01392300|B2|Baseline|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143680|NCT01392300|B1|Baseline|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143681|NCT01392300|P3|Participant Flow|OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
143682|NCT01392300|P2|Participant Flow|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143683|NCT01392300|P1|Participant Flow|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143684|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143685|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143686|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143687|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143688|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143689|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143690|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143691|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143692|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143693|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143694|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143695|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143696|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143697|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143698|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143699|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143700|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143701|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143702|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143703|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143704|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143705|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143706|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143707|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143708|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143709|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143710|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143711|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143712|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143713|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143714|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143715|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143716|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143717|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143718|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143719|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143720|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143721|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143722|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143723|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143724|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143725|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143726|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143727|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143728|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143729|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143730|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143731|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143732|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143733|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143734|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143735|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143736|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143737|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143738|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143739|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143740|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143741|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143742|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143743|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143744|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143745|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143746|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143747|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143748|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143749|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143750|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143751|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143752|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143753|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143754|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143755|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143756|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143757|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143758|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143759|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143760|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143761|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143762|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143763|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143764|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143765|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143766|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143767|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143768|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143769|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143770|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143771|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143772|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143773|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143774|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143775|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143776|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143777|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143778|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143779|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143780|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143781|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143782|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143783|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143784|NCT01392300|E3|Reported Event|OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
143785|NCT01392300|E2|Reported Event|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143786|NCT01392300|E1|Reported Event|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
143787|NCT01392170|B1|Baseline|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
143788|NCT01392170|P1|Participant Flow|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
143789|NCT01392170|O1|Outcome|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
143790|NCT01392170|E1|Reported Event|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
143791|NCT01392053|B3|Baseline|Total|Total of all reporting groups
143792|NCT01392053|B2|Baseline|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143793|NCT01392053|B1|Baseline|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143794|NCT01392053|P2|Participant Flow|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143795|NCT01392053|P1|Participant Flow|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143796|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143797|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143798|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143799|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143800|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143801|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143859|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143803|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143804|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143805|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143806|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143807|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143808|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143809|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143810|NCT01392053|E2|Reported Event|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
143811|NCT01392053|E1|Reported Event|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
143812|NCT01391858|B3|Baseline|Total|Total of all reporting groups
143813|NCT01391858|B2|Baseline|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143814|NCT01391858|B1|Baseline|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143815|NCT01391858|P2|Participant Flow|Placebo|Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
143816|NCT01391858|P1|Participant Flow|Pregabalin|Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
143817|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143818|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143819|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143820|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143821|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143822|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143823|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143824|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143825|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143826|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143827|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143828|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143829|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143830|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143831|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143832|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143833|NCT01391858|E2|Reported Event|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
143834|NCT01391858|E1|Reported Event|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
143835|NCT01391663|B5|Baseline|Total|Total of all reporting groups
143836|NCT01391663|B4|Baseline|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143837|NCT01391663|B3|Baseline|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143838|NCT01391663|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143839|NCT01391663|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143840|NCT01391663|P4|Participant Flow|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143841|NCT01391663|P3|Participant Flow|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143842|NCT01391663|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143843|NCT01391663|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143844|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143845|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143846|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143847|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143848|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143849|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143850|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143851|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143852|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143853|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143854|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143855|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143856|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143857|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143861|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143862|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143863|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143864|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143865|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143866|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143867|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143868|NCT01391663|E4|Reported Event|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
143869|NCT01391663|E3|Reported Event|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
143870|NCT01391663|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
143871|NCT01391663|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
143872|NCT01391468|B3|Baseline|Total|Total of all reporting groups
143873|NCT01391468|B2|Baseline|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
143874|NCT01391468|B1|Baseline|Placebo|Cornstarch: placebo will be given in 6 months
143875|NCT01391468|P2|Participant Flow|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
143876|NCT01391468|P1|Participant Flow|Placebo|Cornstarch: placebo will be given in 6 months
143877|NCT01391468|O2|Outcome|Placebo|Plabeco group received maltodextrin for 6 months
143878|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
143879|NCT01391468|O2|Outcome|Placebo|Placeo group received maltodextrin for 6 months
143880|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
143881|NCT01391468|O2|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
143882|NCT01391468|O1|Outcome|Placebo|"cornstarch~Cornstarch: placebo will be given in 6 months"
143883|NCT01391468|O2|Outcome|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
143884|NCT01391468|O1|Outcome|Placebo|Cornstarch: placebo will be given in 6 months
143885|NCT01391468|E2|Reported Event|Placebo|Cornstarch: placebo will be given in 6 months
143886|NCT01391468|E1|Reported Event|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
143887|NCT01391325|B1|Baseline|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143888|NCT01391325|P1|Participant Flow|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143889|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143890|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143891|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143892|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143893|NCT01391325|E1|Reported Event|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
143894|NCT01391312|B3|Baseline|Total|Total of all reporting groups
143895|NCT01391312|B2|Baseline|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143896|NCT01391312|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143897|NCT01391312|P2|Participant Flow|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143898|NCT01391312|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143899|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143900|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143901|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143902|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143903|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143904|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143905|NCT01391312|E2|Reported Event|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
143906|NCT01391312|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
143907|NCT01391299|B4|Baseline|Total|Total of all reporting groups
155102|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
143908|NCT01391299|B3|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143909|NCT01391299|B2|Baseline|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143910|NCT01391299|B1|Baseline|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143911|NCT01391299|P3|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143912|NCT01391299|P2|Participant Flow|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143913|NCT01391299|P1|Participant Flow|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143914|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143915|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143916|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143917|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143918|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143919|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143920|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143921|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143922|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143923|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143924|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143925|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143926|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143927|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143928|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143929|NCT01391299|E3|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
143930|NCT01391299|E2|Reported Event|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143931|NCT01391299|E1|Reported Event|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
143932|NCT01391286|B3|Baseline|Total|Total of all reporting groups
143933|NCT01391286|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143934|NCT01391286|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143935|NCT01391286|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143936|NCT01391286|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143937|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143938|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143939|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143940|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143941|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143942|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143943|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143944|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143945|NCT01391286|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143946|NCT01391286|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143947|NCT01391273|B3|Baseline|Total|Total of all reporting groups
143948|NCT01391273|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143990|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143949|NCT01391273|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143950|NCT01391273|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143951|NCT01391273|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143952|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143953|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143954|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143955|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143956|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143957|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143958|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143959|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143960|NCT01391273|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
143961|NCT01391273|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
143962|NCT01391013|B3|Baseline|Total|Total of all reporting groups
143963|NCT01391013|B2|Baseline|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143964|NCT01391013|B1|Baseline|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143965|NCT01391013|P2|Participant Flow|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143966|NCT01391013|P1|Participant Flow|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143967|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143968|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143969|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143970|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143971|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143972|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143973|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143974|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143975|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143976|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143977|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143978|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143979|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143980|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143981|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143982|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143983|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143984|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143985|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143986|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143987|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143988|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143989|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
144572|NCT01388816|E3|Reported Event|DRL-17822 150 mg|Once daily after breakfast
143991|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143992|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143993|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143994|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143995|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143996|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143997|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
143998|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
143999|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
144000|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
144001|NCT01391013|E2|Reported Event|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
144002|NCT01391013|E1|Reported Event|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
144003|NCT01390909|B7|Baseline|Total|Total of all reporting groups
144004|NCT01390909|B6|Baseline|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144005|NCT01390909|B5|Baseline|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
144006|NCT01390909|B4|Baseline|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
144007|NCT01390909|B3|Baseline|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144008|NCT01390909|B2|Baseline|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
144009|NCT01390909|B1|Baseline|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
144010|NCT01390909|P6|Participant Flow|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144011|NCT01390909|P5|Participant Flow|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
144012|NCT01390909|P4|Participant Flow|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
144013|NCT01390909|P3|Participant Flow|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144014|NCT01390909|P2|Participant Flow|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
144015|NCT01390909|P1|Participant Flow|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
144016|NCT01390909|O8|Outcome|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144017|NCT01390909|O7|Outcome|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
144018|NCT01390909|O6|Outcome|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
144019|NCT01390909|O5|Outcome|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
144020|NCT01390909|O4|Outcome|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144021|NCT01390909|O3|Outcome|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
144022|NCT01390909|O2|Outcome|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
155103|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
144023|NCT01390909|O1|Outcome|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
144024|NCT01390909|E8|Reported Event|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144025|NCT01390909|E7|Reported Event|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
144026|NCT01390909|E6|Reported Event|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
144027|NCT01390909|E5|Reported Event|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
144028|NCT01390909|E4|Reported Event|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
144029|NCT01390909|E3|Reported Event|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
144030|NCT01390909|E2|Reported Event|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
144031|NCT01390909|E1|Reported Event|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
144032|NCT01390870|B1|Baseline|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
144033|NCT01390870|P1|Participant Flow|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
144034|NCT01390870|O1|Outcome|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
144035|NCT01390870|E1|Reported Event|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
144036|NCT01390857|B1|Baseline|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144037|NCT01390857|P1|Participant Flow|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144038|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144039|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144040|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144041|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144042|NCT01390857|E1|Reported Event|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
144043|NCT01390844|B5|Baseline|Total|Total of all reporting groups
144044|NCT01390844|B4|Baseline|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144045|NCT01390844|B3|Baseline|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144046|NCT01390844|B2|Baseline|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144496|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144047|NCT01390844|B1|Baseline|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144048|NCT01390844|P4|Participant Flow|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144049|NCT01390844|P3|Participant Flow|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144050|NCT01390844|P2|Participant Flow|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144051|NCT01390844|P1|Participant Flow|Boceprevir - Korea+Taiwan|PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144052|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144053|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144054|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144055|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144056|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144057|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144058|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144113|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
155104|NCT01344460|O2|Outcome|Unenhanced MRA|
144059|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144060|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144061|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144062|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144063|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144064|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144065|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144066|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144067|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144068|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144069|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144070|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144093|NCT01390441|P4|Participant Flow|Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144071|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144072|NCT01390844|E4|Reported Event|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144073|NCT01390844|E3|Reported Event|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144074|NCT01390844|E2|Reported Event|Control - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
144075|NCT01390844|E1|Reported Event|Boceprevir - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
144076|NCT01390779|B1|Baseline|SENSIMED Triggerfish|
144077|NCT01390779|P1|Participant Flow|SENSIMED Triggerfish|"All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.~Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points."
144078|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
144079|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
144080|NCT01390779|E1|Reported Event|SENSIMED Triggerfish|
144081|NCT01390649|B1|Baseline|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
144082|NCT01390649|P1|Participant Flow|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
144083|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
144084|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
144085|NCT01390649|E1|Reported Event|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
144086|NCT01390441|B6|Baseline|Total|Total of all reporting groups
144087|NCT01390441|B5|Baseline|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144088|NCT01390441|B4|Baseline|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144089|NCT01390441|B3|Baseline|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144090|NCT01390441|B2|Baseline|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144091|NCT01390441|B1|Baseline|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144092|NCT01390441|P5|Participant Flow|Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144573|NCT01388816|E2|Reported Event|DRL-17822 50 mg|Once daily after breakfast
144094|NCT01390441|P3|Participant Flow|Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144095|NCT01390441|P2|Participant Flow|Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144096|NCT01390441|P1|Participant Flow|Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
144097|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144098|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144099|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144100|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144101|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144102|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144103|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144104|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144105|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144106|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144107|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144108|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
144109|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144110|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144111|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144112|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144574|NCT01388816|E1|Reported Event|Placebo Capsule|Once daily after breakfast
144114|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144115|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144116|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144117|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144118|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144119|NCT01390441|O10|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144120|NCT01390441|O9|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144121|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144122|NCT01390441|O7|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144123|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144124|NCT01390441|O5|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144125|NCT01390441|O4|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144126|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144127|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144128|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144129|NCT01390441|O10|Outcome|Extension B: Rituxan1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144130|NCT01390441|O9|Outcome|Extension B: MabThera 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144131|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144132|NCT01390441|O7|Outcome|Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144133|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144134|NCT01390441|O5|Outcome|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144198|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144135|NCT01390441|O4|Outcome|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144136|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144137|NCT01390441|O2|Outcome|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144138|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144139|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144140|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144141|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144142|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144143|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144144|NCT01390441|E10|Reported Event|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144145|NCT01390441|E9|Reported Event|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144146|NCT01390441|E8|Reported Event|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144147|NCT01390441|E7|Reported Event|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144148|NCT01390441|E6|Reported Event|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144149|NCT01390441|E5|Reported Event|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144150|NCT01390441|E4|Reported Event|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144151|NCT01390441|E3|Reported Event|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144152|NCT01390441|E2|Reported Event|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144153|NCT01390441|E1|Reported Event|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
144154|NCT01390428|B7|Baseline|Total|Total of all reporting groups
144155|NCT01390428|B6|Baseline|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144156|NCT01390428|B5|Baseline|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144157|NCT01390428|B4|Baseline|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144158|NCT01390428|B3|Baseline|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144636|NCT01388361|B4|Baseline|Total|Total of all reporting groups
144159|NCT01390428|B2|Baseline|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144160|NCT01390428|B1|Baseline|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144161|NCT01390428|P6|Participant Flow|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144162|NCT01390428|P5|Participant Flow|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144163|NCT01390428|P4|Participant Flow|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144164|NCT01390428|P3|Participant Flow|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144165|NCT01390428|P2|Participant Flow|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144166|NCT01390428|P1|Participant Flow|Part 1-Mild Hepatic Impairment (HI)|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144167|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144168|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144169|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144170|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144171|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144172|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144173|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144174|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144175|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144176|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144177|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144178|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144179|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144180|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144181|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144182|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144183|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144184|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144185|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144186|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144187|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144188|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144189|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144190|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144191|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144192|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144193|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144194|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144195|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144196|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144197|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144680|NCT01387737|P1|Participant Flow|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
144199|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144200|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144201|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144202|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144203|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144204|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144205|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144206|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144207|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144208|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144209|NCT01390428|E6|Reported Event|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144210|NCT01390428|E5|Reported Event|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
144211|NCT01390428|E4|Reported Event|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144212|NCT01390428|E3|Reported Event|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
144213|NCT01390428|E2|Reported Event|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144214|NCT01390428|E1|Reported Event|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
144215|NCT01390415|B3|Baseline|Total|Total of all reporting groups
144216|NCT01390415|B2|Baseline|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144217|NCT01390415|B1|Baseline|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144218|NCT01390415|P2|Participant Flow|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144219|NCT01390415|P1|Participant Flow|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144220|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144221|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144222|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144223|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144224|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144225|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144226|NCT01390415|E2|Reported Event|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144227|NCT01390415|E1|Reported Event|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
144228|NCT01390402|B1|Baseline|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
144256|NCT01390233|P2|Participant Flow|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
155105|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
144229|NCT01390402|P1|Participant Flow|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
144230|NCT01390402|O1|Outcome|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
144231|NCT01390402|E1|Reported Event|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
144232|NCT01390389|B3|Baseline|Total|Total of all reporting groups
144233|NCT01390389|B2|Baseline|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
144234|NCT01390389|B1|Baseline|Control|Healthy controls with no evidence of current or past psychiatric disorders.
144235|NCT01390389|P2|Participant Flow|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
144236|NCT01390389|P1|Participant Flow|Control|Healthy controls with no evidence of current or past psychiatric disorders.
144237|NCT01390389|O2|Outcome|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
144238|NCT01390389|O1|Outcome|Control|Healthy controls with no evidence of current or past psychiatric disorders.
144239|NCT01390389|E2|Reported Event|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
144240|NCT01390389|E1|Reported Event|Control|Healthy controls with no evidence of current or past psychiatric disorders.
144241|NCT01390259|B1|Baseline|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
144242|NCT01390259|P2|Participant Flow|Closed-Loop Control First, Then Open-Loop|"Closed-Loop control (CLC) first, then Open-Loop~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
144243|NCT01390259|P1|Participant Flow|Open-Loop First, Then Closed-Loop|"Open-Loop first, then Closed-Loop control (CLC)~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
144244|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
144255|NCT01390233|P3|Participant Flow|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
144245|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
144246|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
144247|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
144248|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
144249|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
144250|NCT01390259|E1|Reported Event|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
144251|NCT01390233|B4|Baseline|Total|Total of all reporting groups
144252|NCT01390233|B3|Baseline|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
144253|NCT01390233|B2|Baseline|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
144254|NCT01390233|B1|Baseline|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
144273|NCT01390038|E1|Reported Event|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144318|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144257|NCT01390233|P1|Participant Flow|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
144258|NCT01390233|O3|Outcome|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
144259|NCT01390233|O2|Outcome|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
144260|NCT01390233|O1|Outcome|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
144261|NCT01390233|E3|Reported Event|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
144262|NCT01390233|E2|Reported Event|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
144263|NCT01390233|E1|Reported Event|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
144264|NCT01390038|B1|Baseline|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144265|NCT01390038|P1|Participant Flow|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144266|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144267|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144268|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144269|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144270|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144271|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144272|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
144497|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144274|NCT01389973|B1|Baseline|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144275|NCT01389973|P1|Participant Flow|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144276|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144277|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144278|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144279|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144280|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144281|NCT01389973|E1|Reported Event|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
144282|NCT01389882|B3|Baseline|Total|Total of all reporting groups
144283|NCT01389882|B2|Baseline|NS Group|NAVA first, then SIMV with PS
144284|NCT01389882|B1|Baseline|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
144285|NCT01389882|P2|Participant Flow|NS Group|NAVA first, then SIMV with PS
144286|NCT01389882|P1|Participant Flow|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
144287|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144288|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144289|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144290|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144291|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144292|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144293|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144294|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144295|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144296|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144297|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144298|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144299|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144300|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144301|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144302|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144303|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144304|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144305|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144306|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144307|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144308|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144309|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
144310|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
144311|NCT01389882|E2|Reported Event|NS Group|NAVA first, then SIMV with PS
144312|NCT01389882|E1|Reported Event|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
144313|NCT01389856|B3|Baseline|Total|Total of all reporting groups
144314|NCT01389856|B2|Baseline|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144315|NCT01389856|B1|Baseline|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144316|NCT01389856|P2|Participant Flow|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144317|NCT01389856|P1|Participant Flow|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144498|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144319|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144320|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144321|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144322|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144323|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144324|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144325|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144326|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144327|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144328|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144329|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144330|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144331|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144332|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144333|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144334|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144335|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144336|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144337|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144338|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144339|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144340|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144341|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144342|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144343|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144344|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144345|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144346|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144347|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144348|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144349|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144499|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144350|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144351|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144352|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144353|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144354|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144355|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144356|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144357|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144358|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144359|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144360|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144361|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144362|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144363|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144364|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144365|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144366|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144367|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144368|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144369|NCT01389856|E2|Reported Event|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
144370|NCT01389856|E1|Reported Event|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
144371|NCT01389817|B3|Baseline|Total|Total of all reporting groups
144372|NCT01389817|B2|Baseline|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
144373|NCT01389817|B1|Baseline|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
144374|NCT01389817|P2|Participant Flow|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
144375|NCT01389817|P1|Participant Flow|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
144376|NCT01389817|O2|Outcome|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
144553|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
144377|NCT01389817|O1|Outcome|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
144378|NCT01389817|E2|Reported Event|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
144379|NCT01389817|E1|Reported Event|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
144380|NCT01389323|B1|Baseline|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
144381|NCT01389323|P1|Participant Flow|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
144382|NCT01389323|O5|Outcome|Overall Population|Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
144383|NCT01389323|O4|Outcome|Non-Latino Cohort|Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144384|NCT01389323|O3|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144385|NCT01389323|O2|Outcome|White/Caucasian Cohort|Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
144403|NCT01389284|B1|Baseline|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144462|NCT01389102|E6|Reported Event|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144554|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
144386|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
144387|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
144388|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144389|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
144390|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
144391|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144392|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
144404|NCT01389284|P3|Participant Flow|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144405|NCT01389284|P2|Participant Flow|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144494|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144393|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
144394|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144395|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
144396|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
144397|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
144398|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
144399|NCT01389323|E1|Reported Event|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
144400|NCT01389284|B4|Baseline|Total|Total of all reporting groups
144401|NCT01389284|B3|Baseline|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144402|NCT01389284|B2|Baseline|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144460|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|
144461|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|
144406|NCT01389284|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144407|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144408|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144409|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144410|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144411|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144412|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144413|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144414|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144415|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144416|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144417|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144418|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144419|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144420|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144421|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144422|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144423|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144424|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144425|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144426|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144427|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144495|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144428|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144429|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144430|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144431|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144432|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144433|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144434|NCT01389284|E3|Reported Event|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144435|NCT01389284|E2|Reported Event|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
144436|NCT01389284|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
144437|NCT01389102|B7|Baseline|Total|Total of all reporting groups
144438|NCT01389102|B6|Baseline|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144439|NCT01389102|B5|Baseline|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144440|NCT01389102|B4|Baseline|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144441|NCT01389102|B3|Baseline|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144442|NCT01389102|B2|Baseline|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144443|NCT01389102|B1|Baseline|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144444|NCT01389102|P6|Participant Flow|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144445|NCT01389102|P5|Participant Flow|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144446|NCT01389102|P4|Participant Flow|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144447|NCT01389102|P3|Participant Flow|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144448|NCT01389102|P2|Participant Flow|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144449|NCT01389102|P1|Participant Flow|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144450|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144451|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144452|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144453|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144454|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144455|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144456|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|
144457|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|
144458|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|
144459|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|
144463|NCT01389102|E5|Reported Event|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144464|NCT01389102|E4|Reported Event|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144465|NCT01389102|E3|Reported Event|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
144466|NCT01389102|E2|Reported Event|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144467|NCT01389102|E1|Reported Event|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
144468|NCT01389076|B1|Baseline|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144469|NCT01389076|P1|Participant Flow|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144470|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144471|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144472|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144473|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144474|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144475|NCT01389076|E1|Reported Event|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
144476|NCT01388946|B3|Baseline|Total|Total of all reporting groups
144477|NCT01388946|B2|Baseline|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144478|NCT01388946|B1|Baseline|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144479|NCT01388946|P2|Participant Flow|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144480|NCT01388946|P1|Participant Flow|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144481|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144482|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144483|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144484|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144485|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144486|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144487|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144488|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144489|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144490|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144491|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144492|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144493|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144500|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144501|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144502|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144503|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144504|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144505|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144506|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144507|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144508|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144509|NCT01388946|E2|Reported Event|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
144510|NCT01388946|E1|Reported Event|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
144511|NCT01388920|B4|Baseline|Total|Total of all reporting groups
144512|NCT01388920|B3|Baseline|Placebo|Placebo for 6 months
144513|NCT01388920|B2|Baseline|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
144514|NCT01388920|B1|Baseline|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
144515|NCT01388920|P3|Participant Flow|Placebo|Placebo for 6 monts
144516|NCT01388920|P2|Participant Flow|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
144517|NCT01388920|P1|Participant Flow|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
144518|NCT01388920|O3|Outcome|Placebo|Placebo for 6 months
144519|NCT01388920|O2|Outcome|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
144520|NCT01388920|O1|Outcome|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
144521|NCT01388920|E3|Reported Event|Placebo|Placebo for 6 months
144522|NCT01388920|E2|Reported Event|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
144523|NCT01388920|E1|Reported Event|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
144524|NCT01388907|B3|Baseline|Total|Total of all reporting groups
144525|NCT01388907|B2|Baseline|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144526|NCT01388907|B1|Baseline|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
144527|NCT01388907|P2|Participant Flow|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144528|NCT01388907|P1|Participant Flow|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144529|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144530|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
144531|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144532|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
144533|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144534|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144535|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144536|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
144537|NCT01388907|E2|Reported Event|Ringer Lactate™ (R) Group With Adverse Event|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144538|NCT01388907|E1|Reported Event|Prevadh™ (P) Group With Adverse Event|Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
144539|NCT01388816|B5|Baseline|Total|Total of all reporting groups
144540|NCT01388816|B4|Baseline|DRL-17822 300 mg|Once daily after breakfast
144541|NCT01388816|B3|Baseline|DRL-17822 150 mg|Once daily after breakfast
144542|NCT01388816|B2|Baseline|DRL-17822 50 mg|Once daily after breakfast
144543|NCT01388816|B1|Baseline|Placebo Capsule|Once daily after breakfast
144544|NCT01388816|P4|Participant Flow|DRL-17822 300 mg|Once daily after breakfast
144545|NCT01388816|P3|Participant Flow|DRL-17822 150 mg|Once daily after breakfast
144546|NCT01388816|P2|Participant Flow|DRL-17822 50 mg|Once daily after breakfast
144547|NCT01388816|P1|Participant Flow|Placebo|Once daily after breakfast
144548|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
144549|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
144550|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
144551|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
144552|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
144575|NCT01388790|B1|Baseline|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
144576|NCT01388790|P1|Participant Flow|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
144577|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
144578|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
144579|NCT01388790|E1|Reported Event|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
144580|NCT01388647|B3|Baseline|Total|Total of all reporting groups
144581|NCT01388647|B2|Baseline|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144582|NCT01388647|B1|Baseline|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144583|NCT01388647|P2|Participant Flow|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144584|NCT01388647|P1|Participant Flow|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144585|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144586|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144587|NCT01388647|O1|Outcome|All Study Participants|All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
144588|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144589|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144590|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144591|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144592|NCT01388647|E2|Reported Event|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
144593|NCT01388647|E1|Reported Event|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
144594|NCT01388530|B1|Baseline|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144595|NCT01388530|P1|Participant Flow|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144596|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144597|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144598|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144599|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144600|NCT01388530|E1|Reported Event|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
144601|NCT01388491|B3|Baseline|Total|Total of all reporting groups
144602|NCT01388491|B2|Baseline|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144603|NCT01388491|B1|Baseline|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144604|NCT01388491|P2|Participant Flow|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144605|NCT01388491|P1|Participant Flow|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144606|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144607|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144608|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144609|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144610|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144611|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144612|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144613|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144614|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144615|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144616|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144617|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144618|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144619|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144620|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144621|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144622|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144623|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144624|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144625|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144626|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144627|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144628|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144629|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144630|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144631|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144632|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144633|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144634|NCT01388491|E2|Reported Event|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
144635|NCT01388491|E1|Reported Event|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
144637|NCT01388361|B3|Baseline|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144638|NCT01388361|B2|Baseline|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144639|NCT01388361|B1|Baseline|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144640|NCT01388361|P3|Participant Flow|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144641|NCT01388361|P2|Participant Flow|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144642|NCT01388361|P1|Participant Flow|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144643|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144644|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144645|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144646|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144647|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144648|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144649|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144650|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144651|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144681|NCT01387737|O2|Outcome|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
144682|NCT01387737|O1|Outcome|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
144652|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144653|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144654|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144655|NCT01388361|E3|Reported Event|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144656|NCT01388361|E2|Reported Event|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
144657|NCT01388361|E1|Reported Event|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
144658|NCT01388166|B1|Baseline|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
144659|NCT01388166|P1|Participant Flow|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
144660|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
144661|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
144662|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
144663|NCT01388166|E1|Reported Event|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
144664|NCT01387789|B1|Baseline|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144665|NCT01387789|P1|Participant Flow|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144666|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144667|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144668|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144669|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144670|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144671|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144672|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144673|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144674|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144675|NCT01387789|E1|Reported Event|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
144676|NCT01387737|B3|Baseline|Total|Total of all reporting groups
144677|NCT01387737|B2|Baseline|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
144678|NCT01387737|B1|Baseline|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
144679|NCT01387737|P2|Participant Flow|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
144683|NCT01387737|E2|Reported Event|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
144684|NCT01387737|E1|Reported Event|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
144685|NCT01387672|B7|Baseline|Total|Total of all reporting groups
144686|NCT01387672|B6|Baseline|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
144687|NCT01387672|B5|Baseline|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
144688|NCT01387672|B4|Baseline|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
144689|NCT01387672|B3|Baseline|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
144690|NCT01387672|B2|Baseline|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
144691|NCT01387672|B1|Baseline|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
144692|NCT01387672|P6|Participant Flow|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Nitrates (NABT Main trial)"
144693|NCT01387672|P5|Participant Flow|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
144694|NCT01387672|P4|Participant Flow|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
144695|NCT01387672|P3|Participant Flow|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
144696|NCT01387672|P2|Participant Flow|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
144697|NCT01387672|P1|Participant Flow|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
144698|NCT01387672|O1|Outcome|Run-in Phase|During the run-in phase subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. The severity of headaches was recorded, by subjects, upon awakening, every day during the run in phase using a visual analog scale (VAS).
144699|NCT01387672|O6|Outcome|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
144700|NCT01387672|O5|Outcome|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
144701|NCT01387672|O4|Outcome|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
144702|NCT01387672|O3|Outcome|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
144703|NCT01387672|O2|Outcome|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
144704|NCT01387672|O1|Outcome|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
144705|NCT01387672|E6|Reported Event|Placebo Ointment- Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
144706|NCT01387672|E5|Reported Event|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
144707|NCT01387672|E4|Reported Event|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
144708|NCT01387672|E3|Reported Event|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
144709|NCT01387672|E2|Reported Event|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
144710|NCT01387672|E1|Reported Event|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
144711|NCT01387581|B4|Baseline|Total|Total of all reporting groups
144712|NCT01387581|B3|Baseline|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144713|NCT01387581|B2|Baseline|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
144714|NCT01387581|B1|Baseline|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144715|NCT01387581|P3|Participant Flow|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144716|NCT01387581|P2|Participant Flow|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
144717|NCT01387581|P1|Participant Flow|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144718|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144719|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
144720|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144721|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144722|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
144723|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144724|NCT01387581|E3|Reported Event|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144842|NCT01386983|B3|Baseline|Total|Total of all reporting groups
144725|NCT01387581|E2|Reported Event|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
144726|NCT01387581|E1|Reported Event|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
144727|NCT01387542|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144728|NCT01387542|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144729|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144730|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144731|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144732|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144733|NCT01387542|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
144734|NCT01387464|B3|Baseline|Total|Total of all reporting groups
144735|NCT01387464|B2|Baseline|Bromday|0.09% bromfenac dosed QD
144736|NCT01387464|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
144737|NCT01387464|P2|Participant Flow|Bromday|0.09% bromfenac dosed QD
144738|NCT01387464|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
144739|NCT01387464|O2|Outcome|Bromday|0.09% bromfenac dosed QD
144740|NCT01387464|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
144741|NCT01387464|E2|Reported Event|Bromday|0.09% bromfenac dosed QD
144742|NCT01387464|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
144743|NCT01387347|B3|Baseline|Total|Total of all reporting groups
144744|NCT01387347|B2|Baseline|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144745|NCT01387347|B1|Baseline|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144746|NCT01387347|P2|Participant Flow|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144747|NCT01387347|P1|Participant Flow|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144748|NCT01387347|O2|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
144749|NCT01387347|O1|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
144750|NCT01387347|O2|Outcome|Thymosin Beta 4|Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
144751|NCT01387347|O1|Outcome|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144752|NCT01387347|O2|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
144753|NCT01387347|O1|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
144754|NCT01387347|E2|Reported Event|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144755|NCT01387347|E1|Reported Event|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
144756|NCT01387230|B4|Baseline|Total|Total of all reporting groups
144757|NCT01387230|B3|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144758|NCT01387230|B2|Baseline|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
144759|NCT01387230|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
144760|NCT01387230|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144761|NCT01387230|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
144948|NCT01385566|B7|Baseline|Total|Total of all reporting groups
144762|NCT01387230|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12 weeks.
144763|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144764|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
144765|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
144766|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144767|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
144768|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
144769|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144770|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
144771|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
144772|NCT01387230|E3|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
144773|NCT01387230|E2|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
144774|NCT01387230|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
144775|NCT01387178|B3|Baseline|Total|Total of all reporting groups
144776|NCT01387178|B2|Baseline|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
144777|NCT01387178|B1|Baseline|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
144778|NCT01387178|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
144779|NCT01387178|P1|Participant Flow|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC)
144780|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
144781|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
144782|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
144783|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
144784|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
144785|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
144786|NCT01387178|E2|Reported Event|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
144787|NCT01387178|E1|Reported Event|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
144788|NCT01387139|B3|Baseline|Total|Total of all reporting groups
144789|NCT01387139|B2|Baseline|Ketamine Co-Administered With Propofol|
144790|NCT01387139|B1|Baseline|Ketamine Alone|
155106|NCT01344460|O2|Outcome|Unenhanced MRA|
144791|NCT01387139|P2|Participant Flow|Ketamine Co-Administered With Propofol|Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
144792|NCT01387139|P1|Participant Flow|Ketamine Alone|Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
144793|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144794|NCT01387139|O1|Outcome|Ketamine Alone|
144795|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144796|NCT01387139|O1|Outcome|Ketamine Alone|
144797|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144798|NCT01387139|O1|Outcome|Ketamine Alone|
144799|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144800|NCT01387139|O1|Outcome|Ketamine Alone|
144801|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144802|NCT01387139|O1|Outcome|Ketamine Alone|
144803|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
144804|NCT01387139|O1|Outcome|Ketamine Alone|
144805|NCT01387139|E2|Reported Event|Ketamine Co-Administered With Propofol|
144806|NCT01387139|E1|Reported Event|Ketamine Alone|
144807|NCT01387074|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144808|NCT01387074|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144809|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144810|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144811|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144812|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144813|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144814|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144815|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144816|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144817|NCT01387074|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
144818|NCT01386008|B1|Baseline|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
144819|NCT01386008|P1|Participant Flow|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
144820|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
144821|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
144822|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
144823|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
144824|NCT01386008|E1|Reported Event|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
144825|NCT01385995|B3|Baseline|Total|Total of all reporting groups
144826|NCT01385995|B2|Baseline|Sham-Continuous Positive Airway Pressure|
144827|NCT01385995|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|
144828|NCT01385995|P2|Participant Flow|Sham-Continuous Positive Airway Pressure|
144829|NCT01385995|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|
144830|NCT01385995|O2|Outcome|Sham CPAP|
144831|NCT01385995|O1|Outcome|Therapeutic CPAP|
144832|NCT01385995|O2|Outcome|Sham CPAP|
144833|NCT01385995|O1|Outcome|Therapeutic CPAP|
144834|NCT01385995|O2|Outcome|Sham CPAP|
144835|NCT01385995|O1|Outcome|Therapeutic CPAP|
144836|NCT01385995|O2|Outcome|Sham CPAP|
144837|NCT01385995|O1|Outcome|Therapeutic CPAP|
144838|NCT01385995|O2|Outcome|Sham CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
144839|NCT01385995|O1|Outcome|Therapeutic CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.
144840|NCT01385995|E2|Reported Event|Sham-Continuous Positive Airway Pressure|
144841|NCT01385995|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|
144843|NCT01386983|B2|Baseline|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
144844|NCT01386983|B1|Baseline|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
144845|NCT01386983|P2|Participant Flow|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
144846|NCT01386983|P1|Participant Flow|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
144847|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
144848|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
144849|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
144850|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
144851|NCT01386983|E2|Reported Event|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
144852|NCT01386983|E1|Reported Event|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
144853|NCT01386944|B1|Baseline|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144854|NCT01386944|P1|Participant Flow|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144855|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144856|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144857|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144858|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144859|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144860|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144861|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144862|NCT01386944|E1|Reported Event|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
144863|NCT01386788|B1|Baseline|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
144864|NCT01386788|P1|Participant Flow|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
144865|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
144866|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
144867|NCT01386788|E1|Reported Event|Smoke Inhalation Victim|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed
144868|NCT01386606|B5|Baseline|Total|Total of all reporting groups
144869|NCT01386606|B4|Baseline|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144870|NCT01386606|B3|Baseline|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144871|NCT01386606|B2|Baseline|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144872|NCT01386606|B1|Baseline|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144873|NCT01386606|P4|Participant Flow|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144874|NCT01386606|P3|Participant Flow|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144875|NCT01386606|P2|Participant Flow|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144876|NCT01386606|P1|Participant Flow|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144877|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144878|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144879|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144880|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144881|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144882|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144883|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144884|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144885|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144886|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144887|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144888|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144889|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
144890|NCT01386606|O1|Outcome|Androxal Pooled Dose Levels|Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
144891|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144892|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144893|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144894|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144895|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144896|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144897|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144898|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144899|NCT01386606|E4|Reported Event|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
144900|NCT01386606|E3|Reported Event|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144901|NCT01386606|E2|Reported Event|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144902|NCT01386606|E1|Reported Event|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
144903|NCT01386125|B3|Baseline|Total|Total of all reporting groups
144904|NCT01386125|B2|Baseline|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
144905|NCT01386125|B1|Baseline|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
144906|NCT01386125|P2|Participant Flow|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
144907|NCT01386125|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
144908|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
144909|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
144910|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
144911|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
144912|NCT01386125|E2|Reported Event|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
144913|NCT01386125|E1|Reported Event|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
144914|NCT01385696|B1|Baseline|Overall Study Safety Population|All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population
144915|NCT01385696|P2|Participant Flow|Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)|Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
144916|NCT01385696|P1|Participant Flow|Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)|Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
144917|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
144918|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
144919|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
144920|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
144921|NCT01385696|O1|Outcome|Overall Intention-to-treat Population|Overall intention-to-treat (ITT) population
144922|NCT01385696|E2|Reported Event|HandiHaler Then Genuair|The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo.
144923|NCT01385696|E1|Reported Event|Genuair Then HandiHaler|The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo.
144924|NCT01385644|B3|Baseline|Total|Total of all reporting groups
144925|NCT01385644|B2|Baseline|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144926|NCT01385644|B1|Baseline|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144927|NCT01385644|P2|Participant Flow|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144928|NCT01385644|P1|Participant Flow|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
145293|NCT01383356|E2|Reported Event|Lina 2.5mg Plus Met 500mg|Single tablets
144929|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144930|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144931|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144932|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144933|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144934|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144935|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144936|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144937|NCT01385644|E2|Reported Event|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144938|NCT01385644|E1|Reported Event|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
144939|NCT01385579|B3|Baseline|Total|Total of all reporting groups
144940|NCT01385579|B2|Baseline|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
144941|NCT01385579|B1|Baseline|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
144942|NCT01385579|P2|Participant Flow|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
144943|NCT01385579|P1|Participant Flow|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
144944|NCT01385579|O2|Outcome|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
144945|NCT01385579|O1|Outcome|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
144946|NCT01385579|E2|Reported Event|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
144947|NCT01385579|E1|Reported Event|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
144949|NCT01385566|B6|Baseline|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144950|NCT01385566|B5|Baseline|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144951|NCT01385566|B4|Baseline|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144952|NCT01385566|B3|Baseline|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144953|NCT01385566|B2|Baseline|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144954|NCT01385566|B1|Baseline|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144955|NCT01385566|P6|Participant Flow|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144956|NCT01385566|P5|Participant Flow|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144957|NCT01385566|P4|Participant Flow|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144958|NCT01385566|P3|Participant Flow|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144959|NCT01385566|P2|Participant Flow|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144960|NCT01385566|P1|Participant Flow|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144961|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144962|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144963|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144964|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144965|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144966|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144967|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144968|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145082|NCT01384019|B2|Baseline|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
144969|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144970|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144971|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144972|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144973|NCT01385566|O7|Outcome|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
144974|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144975|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144976|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144977|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144978|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144979|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144980|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144981|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144982|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144983|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144984|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144985|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144986|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144987|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144988|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145294|NCT01383356|E1|Reported Event|Lina/Met 2.5mg/500mg|Combination tablet
144989|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144990|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144991|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144992|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144993|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144994|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144995|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144996|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144997|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
144998|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
144999|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145000|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145001|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145002|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145003|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
145004|NCT01385566|E7|Reported Event|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
145005|NCT01385566|E6|Reported Event|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145006|NCT01385566|E5|Reported Event|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145007|NCT01385566|E4|Reported Event|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145008|NCT01385566|E3|Reported Event|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145084|NCT01384019|P2|Participant Flow|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
145009|NCT01385566|E2|Reported Event|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
145010|NCT01385566|E1|Reported Event|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
145011|NCT01385371|B3|Baseline|Total|Total of all reporting groups
145012|NCT01385371|B2|Baseline|Placebo|Participants receiving Placebo
145013|NCT01385371|B1|Baseline|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145014|NCT01385371|P2|Participant Flow|Placebo|Participants receiving Placebo
145015|NCT01385371|P1|Participant Flow|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145016|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145017|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145018|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145019|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145020|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145021|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145022|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145023|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145024|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145025|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145026|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145027|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145028|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145029|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145030|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
145031|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145032|NCT01385371|E2|Reported Event|Placebo|Participants receiving Placebo
145033|NCT01385371|E1|Reported Event|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
145034|NCT01385202|B1|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
145035|NCT01385202|P1|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
145036|NCT01385202|O2|Outcome|Calibration Roll-in|Calibration roll-in case(s) is intended to calibrate an investigator’s tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
145037|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.
145038|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
145039|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
145040|NCT01385202|E1|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
145041|NCT01385033|B3|Baseline|Total|Total of all reporting groups
145042|NCT01385033|B2|Baseline|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145043|NCT01385033|B1|Baseline|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145044|NCT01385033|P6|Participant Flow|Amnestic Mild Cognitive Impairment Participants (Part III)|Participants with amnestic Mild Cognitive Impairment received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part III)
145045|NCT01385033|P5|Participant Flow|Healthy Young (HY) Participants (Part II)|HY participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
145046|NCT01385033|P4|Participant Flow|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
145047|NCT01385033|P3|Participant Flow|AD Participants (Part II)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by PET imaging of the brain (Part II)
145048|NCT01385033|P2|Participant Flow|Healthy Elderly (HE) Participants (Part I)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part I)
145049|NCT01385033|P1|Participant Flow|Alzheimer's Disease (AD) Participants (Part I)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by positron emission tomography (PET) imaging of the brain (Part I)
145050|NCT01385033|O1|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145051|NCT01385033|O2|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145052|NCT01385033|O1|Outcome|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145053|NCT01385033|O1|Outcome|AD and HE Participants|AD and HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145054|NCT01385033|E1|Reported Event|All Study Participants|Participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
145055|NCT01384760|B3|Baseline|Total|Total of all reporting groups
145083|NCT01384019|B1|Baseline|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
145295|NCT01383213|B3|Baseline|Total|Total of all reporting groups
155107|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
145056|NCT01384760|B2|Baseline|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
145057|NCT01384760|B1|Baseline|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
145058|NCT01384760|P2|Participant Flow|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
145059|NCT01384760|P1|Participant Flow|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
145060|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
145061|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
145062|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
145063|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
145064|NCT01384760|E2|Reported Event|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
145065|NCT01384760|E1|Reported Event|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
145066|NCT01384292|B4|Baseline|Total|Total of all reporting groups
145067|NCT01384292|B3|Baseline|Placebo|Placebo, oral treatment
145068|NCT01384292|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
145069|NCT01384292|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
145070|NCT01384292|P3|Participant Flow|Placebo|Placebo, oral treatment
145071|NCT01384292|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
145072|NCT01384292|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
145073|NCT01384292|O3|Outcome|Placebo|Placebo, oral treatment
145074|NCT01384292|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
145075|NCT01384292|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
145076|NCT01384292|E5|Reported Event|NKTR-118 25 mg - Part B|Part B NKTR-118 25 mg, oral treatment
145077|NCT01384292|E4|Reported Event|NKTR-118 12.5 mg - Part B|Part B NKTR-118 12.5 mg, oral treatment
145078|NCT01384292|E3|Reported Event|Placebo - Part A|Part A Placebo, oral treatment
145079|NCT01384292|E2|Reported Event|NKTR-118 25 mg - Part A|Part A NKTR-118 25 mg, oral treatment
145080|NCT01384292|E1|Reported Event|NKTR-118 12.5 mg - Part A|Part A NKTR-118 12.5 mg, oral treatment
145081|NCT01384019|B3|Baseline|Total|Total of all reporting groups
145085|NCT01384019|P1|Participant Flow|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
145086|NCT01384019|O2|Outcome|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
145087|NCT01384019|O1|Outcome|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
145088|NCT01384019|E2|Reported Event|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
145089|NCT01384019|E1|Reported Event|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
145090|NCT01383993|B4|Baseline|Total|Total of all reporting groups
145091|NCT01383993|B3|Baseline|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145092|NCT01383993|B2|Baseline|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145093|NCT01383993|B1|Baseline|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145094|NCT01383993|P3|Participant Flow|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145095|NCT01383993|P2|Participant Flow|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145096|NCT01383993|P1|Participant Flow|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145097|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145098|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145099|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145100|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145101|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145296|NCT01383213|B2|Baseline|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
145102|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145103|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145104|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145105|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145106|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145107|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145108|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145109|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145110|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145111|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145112|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145113|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145114|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145297|NCT01383213|B1|Baseline|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
145115|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145116|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145117|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145118|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145119|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145120|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145121|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145122|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145123|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145124|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145125|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145126|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145127|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145298|NCT01383213|P2|Participant Flow|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
145128|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145129|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145130|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145131|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145132|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145133|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145134|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145135|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145136|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145137|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145138|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145139|NCT01383993|E3|Reported Event|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145140|NCT01383993|E2|Reported Event|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145347|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
145141|NCT01383993|E1|Reported Event|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
145142|NCT01383928|B4|Baseline|Total|Total of all reporting groups
145143|NCT01383928|B3|Baseline|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145144|NCT01383928|B2|Baseline|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145145|NCT01383928|B1|Baseline|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145146|NCT01383928|P3|Participant Flow|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145147|NCT01383928|P2|Participant Flow|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145148|NCT01383928|P1|Participant Flow|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145149|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145150|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145151|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145152|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145153|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145154|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145155|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145156|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145157|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145158|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145159|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145246|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145247|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145248|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145160|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145161|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145162|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145163|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145164|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145165|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145166|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145167|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145168|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145249|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145250|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145169|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145170|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145171|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145172|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145173|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving the same dose of ixazomib (MLN9708) capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145174|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145175|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145176|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145177|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145251|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145252|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145431|NCT01382901|E1|Reported Event|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
145178|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145179|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145180|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145181|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145182|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145183|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145184|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145185|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145186|NCT01383928|E3|Reported Event|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145253|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145254|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145432|NCT01382719|B5|Baseline|Total|Total of all reporting groups
145433|NCT01382719|B4|Baseline|Bremelanotide Arm 3|high dose 1.75 mg BMT
145187|NCT01383928|E2|Reported Event|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145188|NCT01383928|E1|Reported Event|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
145189|NCT01383720|B1|Baseline|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145190|NCT01383720|P1|Participant Flow|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145191|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145192|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145193|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145194|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145195|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145196|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145197|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145198|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145199|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145200|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145201|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145202|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145203|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145204|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145205|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145206|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145207|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145208|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145209|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145210|NCT01383720|E1|Reported Event|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
145211|NCT01383707|B1|Baseline|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145255|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145256|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145257|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145258|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145434|NCT01382719|B3|Baseline|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145212|NCT01383707|P1|Participant Flow|Bevacizumab + Modified FOLFOX-6 (mFOLFOX-6)|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145213|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145214|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145215|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145216|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145217|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145218|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145259|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145260|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145435|NCT01382719|B2|Baseline|Bremelanotide Arm 1|low dose 0.75 mg BMT
145219|NCT01383707|E1|Reported Event|Bevacizumab + mFOLFOX-6|"Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy).~5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle"
145220|NCT01383681|B1|Baseline|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
145221|NCT01383681|P1|Participant Flow|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
145222|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
145223|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
145224|NCT01383681|E1|Reported Event|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
145225|NCT01383499|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
145226|NCT01383499|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Period 1, with Tiotropium 1.25 mcg in Period 2 and with Placebo in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
145227|NCT01383499|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with Placebo in Period 1, with Tiotropium 2.5 mcg in Period 2 and with Tiotropium 5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
145228|NCT01383499|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Period 1, with Tiotropium 5 mcg in Period 2 and with Tiotropium 2.5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
145229|NCT01383499|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Period 1, with Placebo in Period 2 and with Tiotropium 1.25 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
145230|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145231|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145232|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145233|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145234|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145235|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145236|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145237|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145238|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145239|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145240|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145241|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145242|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145243|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145244|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145245|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145261|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145262|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145263|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145264|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145265|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145266|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145267|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145268|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145269|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145270|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145271|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145272|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145273|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145274|NCT01383499|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145275|NCT01383499|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145276|NCT01383499|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145277|NCT01383499|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
145278|NCT01383486|B1|Baseline|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145279|NCT01383486|P1|Participant Flow|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145280|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145281|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145282|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145283|NCT01383486|E1|Reported Event|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
145284|NCT01383356|B1|Baseline|Entire Study Population|Total number of subjects randomised and treated in the study.
145285|NCT01383356|P2|Participant Flow|Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg|Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg
145286|NCT01383356|P1|Participant Flow|Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg|Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
145287|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
145288|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
145289|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
145290|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
145291|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
145292|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
145299|NCT01383213|P1|Participant Flow|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
145300|NCT01383213|O2|Outcome|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
145301|NCT01383213|O1|Outcome|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
145302|NCT01383213|E2|Reported Event|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
145303|NCT01383213|E1|Reported Event|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
145304|NCT01383200|B3|Baseline|Total|Total of all reporting groups
145305|NCT01383200|B2|Baseline|TetracaineLeft Eye /LidocaineRight Eye|0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye
145306|NCT01383200|B1|Baseline|TetracaineRight Eye / LidocaineLeft Eye|0.5% tetracaine drops Right eye /2% lidocaine gel Left eye
145307|NCT01383200|P2|Participant Flow|Tetracaine Left Eye / Lidocaine Right Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 20% lidocaine gel."
145308|NCT01383200|P1|Participant Flow|Tetracaine Right Eye / Lidocaine Left Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 0.5% tetracaine drops."
145309|NCT01383200|O2|Outcome|Lidocaine|2% lidocaine gel
145310|NCT01383200|O1|Outcome|Tetracaine|0.5% tetracaine drops
145311|NCT01383200|E2|Reported Event|Tetracaine Left Eye / Lidocaine Right Eye|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
145312|NCT01383200|E1|Reported Event|Tetracaine Right Eye / Lidocaine Left Eye|0.5% Tetracaine drops Right eye / 2% Lidocaine Left eye
145313|NCT01383174|B3|Baseline|Total|Total of all reporting groups
145314|NCT01383174|B2|Baseline|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145315|NCT01383174|B1|Baseline|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145316|NCT01383174|P2|Participant Flow|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145317|NCT01383174|P1|Participant Flow|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145318|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145319|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145320|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145321|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145322|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145323|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145324|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145348|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
145349|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
145325|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145326|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145327|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145328|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145329|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145330|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145331|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145332|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145333|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145334|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145335|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145336|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145337|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145338|NCT01383174|E2|Reported Event|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
145339|NCT01383174|E1|Reported Event|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
145340|NCT01383096|B4|Baseline|Total|Total of all reporting groups
145341|NCT01383096|B3|Baseline|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
145342|NCT01383096|B2|Baseline|Cohort 2|Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
145343|NCT01383096|B1|Baseline|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
145344|NCT01383096|P3|Participant Flow|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
145345|NCT01383096|P2|Participant Flow|Cohort 2|Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
145346|NCT01383096|P1|Participant Flow|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
145350|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
145351|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145352|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145353|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
145354|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
145355|NCT01383096|O3|Outcome|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145356|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145357|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
145358|NCT01383096|O11|Outcome|Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
145359|NCT01383096|O10|Outcome|Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
145360|NCT01383096|O9|Outcome|Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
145361|NCT01383096|O8|Outcome|Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
145362|NCT01383096|O7|Outcome|Cohort 2 - Treatement G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145363|NCT01383096|O6|Outcome|Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145364|NCT01383096|O5|Outcome|Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
145365|NCT01383096|O4|Outcome|Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
145366|NCT01383096|O3|Outcome|Cohort 1 - Treatment C:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145367|NCT01383096|O2|Outcome|Cohort 1 - Treatement B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145368|NCT01383096|O1|Outcome|Cohort 1 - Treatement A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
145369|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
145370|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
145371|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
145372|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
145373|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145374|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted
145375|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
145376|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
145377|NCT01383096|O3|Outcome|Cohort 1 - Treatment:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145378|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145379|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
145380|NCT01383096|E11|Reported Event|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
145381|NCT01383096|E10|Reported Event|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
145382|NCT01383096|E9|Reported Event|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
145383|NCT01383096|E8|Reported Event|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
145384|NCT01383096|E7|Reported Event|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145385|NCT01383096|E6|Reported Event|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145386|NCT01383096|E5|Reported Event|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
145387|NCT01383096|E4|Reported Event|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
145388|NCT01383096|E3|Reported Event|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
145389|NCT01383096|E2|Reported Event|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
145390|NCT01383096|E1|Reported Event|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
145391|NCT01383005|B3|Baseline|Total|Total of all reporting groups
145392|NCT01383005|B2|Baseline|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145393|NCT01383005|B1|Baseline|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145394|NCT01383005|P2|Participant Flow|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145395|NCT01383005|P1|Participant Flow|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145396|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145397|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145398|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145399|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145400|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145401|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145402|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145403|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145404|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145405|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145406|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145407|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145408|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145409|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
145410|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
145411|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145412|NCT01383005|E1|Reported Event|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
145413|NCT01382940|B1|Baseline|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145414|NCT01382940|P1|Participant Flow|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145415|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145416|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145417|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145418|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145419|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145420|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145421|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145422|NCT01382940|E1|Reported Event|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
145423|NCT01382901|B3|Baseline|Total|Total of all reporting groups
145424|NCT01382901|B2|Baseline|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
145425|NCT01382901|B1|Baseline|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
145426|NCT01382901|P2|Participant Flow|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
145427|NCT01382901|P1|Participant Flow|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
145428|NCT01382901|O2|Outcome|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
145429|NCT01382901|O1|Outcome|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
145430|NCT01382901|E2|Reported Event|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
145436|NCT01382719|B1|Baseline|Placebo|identical formulation without active ingredient
145437|NCT01382719|P4|Participant Flow|Bremelanotide Arm 3|high dose 1.75 mg BMT
145438|NCT01382719|P3|Participant Flow|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145439|NCT01382719|P2|Participant Flow|Bremelanotide Arm 1|low dose 0.75 mg BMT
145440|NCT01382719|P1|Participant Flow|Placebo|identical formulation without active ingredient
145441|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145442|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145443|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145444|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145445|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145446|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145447|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145448|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145449|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145450|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145451|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145452|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145453|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145454|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145455|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145456|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145457|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145458|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145459|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145460|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145461|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145462|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145463|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145464|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145465|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
145466|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145467|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
145468|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
145469|NCT01382719|E4|Reported Event|Bremelanotide Arm 3|high dose 1.75 mg BMT
145470|NCT01382719|E3|Reported Event|Bremelanotide Arm 2|middle dose 1.25 mg BMT
145471|NCT01382719|E2|Reported Event|Bremelanotide Arm 1|low dose 0.75 mg BMT
145472|NCT01382719|E1|Reported Event|Placebo|identical formulation without active ingredient
145473|NCT01382446|B3|Baseline|Total|Total of all reporting groups
145474|NCT01382446|B2|Baseline|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
145475|NCT01382446|B1|Baseline|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
145476|NCT01382446|P2|Participant Flow|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
145477|NCT01382446|P1|Participant Flow|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
145478|NCT01382446|O2|Outcome|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
145479|NCT01382446|O1|Outcome|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
145480|NCT01382446|E2|Reported Event|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
145481|NCT01382446|E1|Reported Event|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
145482|NCT01382251|B3|Baseline|Total|Total of all reporting groups
145483|NCT01382251|B2|Baseline|Ambulatory Surgery Caregivers|Caregivers were recruited with the patients receiving surgery
145484|NCT01382251|B1|Baseline|Ambulatory Surgery Patients|Only patients with caregivers were recruited
145485|NCT01382251|P2|Participant Flow|Ambulatory Surgery Caregivers|
145486|NCT01382251|P1|Participant Flow|Ambulatory Surgery Patients|
145487|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
145488|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
145489|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
145490|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
145491|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
145492|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
145493|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
145494|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
145495|NCT01382251|E1|Reported Event|Ambulatory Surgery Patients|
145496|NCT01382225|B3|Baseline|Total|Total of all reporting groups
145497|NCT01382225|B2|Baseline|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145498|NCT01382225|B1|Baseline|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145499|NCT01382225|P2|Participant Flow|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145500|NCT01382225|P1|Participant Flow|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145501|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145502|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145503|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145504|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145505|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145506|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145507|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145508|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145509|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145510|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145511|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145512|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145513|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145514|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145515|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145516|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145517|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145518|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145519|NCT01382225|E2|Reported Event|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145520|NCT01382225|E1|Reported Event|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
145521|NCT01382212|B1|Baseline|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145522|NCT01382212|P1|Participant Flow|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145523|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145524|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145525|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145526|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145527|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145528|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145529|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145530|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145531|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145532|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145533|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145534|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145535|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145536|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145537|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145538|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145539|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145540|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145541|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145542|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145543|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145544|NCT01382212|E1|Reported Event|Paricalcitol|Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
145545|NCT01382186|B3|Baseline|Total|Total of all reporting groups
145546|NCT01382186|B2|Baseline|Random Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
155108|NCT01344460|O2|Outcome|Unenhanced MRA|
145547|NCT01382186|B1|Baseline|Purposive Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
145548|NCT01382186|P2|Participant Flow|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145549|NCT01382186|P1|Participant Flow|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
145550|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145551|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145552|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145553|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145554|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145555|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
145556|NCT01382186|O1|Outcome|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
145557|NCT01382186|O3|Outcome|Purposive Sampling: Not Able to Complete Task|Veterans in this arm were not able to complete the task.
145558|NCT01382186|O2|Outcome|Purposive Sampling: Able to Complete Task With Difficulty|Veterans in this arm were able to complete task with some difficulty.
145559|NCT01382186|O1|Outcome|Purposive Sampling: Able to Complete Task|Veterans in this arm were able to complete the task.
145560|NCT01382186|E2|Reported Event|Random Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
145561|NCT01382186|E1|Reported Event|Purposive Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
145562|NCT01382108|B3|Baseline|Total|Total of all reporting groups
145563|NCT01382108|B2|Baseline|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145564|NCT01382108|B1|Baseline|Normal Participants|Participants without meibomian gland dysfunction
145565|NCT01382108|P2|Participant Flow|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145566|NCT01382108|P1|Participant Flow|Normal Participants|Participants without Meibomian Gland Dysfunction
145567|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145568|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
145569|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145570|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
145571|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145572|NCT01382108|O1|Outcome|Normal Participants|Participants without Meibomian Gland Dysfunction
145573|NCT01382108|E2|Reported Event|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
145574|NCT01382108|E1|Reported Event|Normal Participants|Participants without meibomian gland dysfunction
145575|NCT01381952|B1|Baseline|AlluraXper - ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
145576|NCT01381952|P1|Participant Flow|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
145577|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
145578|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
145579|NCT01381952|O2|Outcome|Allura Clarity|Angiogram with AlluraXper followed by angiogram with ClarityIQ
145580|NCT01381952|O1|Outcome|AlluraXper|Angiogram with AlluraXper followed by angiogram with ClarityIQ
145581|NCT01381952|E1|Reported Event|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
145582|NCT01381900|B4|Baseline|Total|Total of all reporting groups
145583|NCT01381900|B3|Baseline|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145584|NCT01381900|B2|Baseline|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145585|NCT01381900|B1|Baseline|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145586|NCT01381900|P3|Participant Flow|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145587|NCT01381900|P2|Participant Flow|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145588|NCT01381900|P1|Participant Flow|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145589|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145590|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145591|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145592|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145593|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145594|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145595|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145596|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145597|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145598|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145599|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145600|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145601|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145602|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145603|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145604|NCT01381900|E3|Reported Event|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145605|NCT01381900|E2|Reported Event|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145606|NCT01381900|E1|Reported Event|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
145607|NCT01381679|B1|Baseline|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145608|NCT01381679|P1|Participant Flow|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145609|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145610|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145611|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145612|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145613|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145614|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145615|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145616|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145617|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145618|NCT01381679|E1|Reported Event|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
145619|NCT01381575|B4|Baseline|Total|Total of all reporting groups
145620|NCT01381575|B3|Baseline|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145621|NCT01381575|B2|Baseline|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145622|NCT01381575|B1|Baseline|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145623|NCT01381575|P3|Participant Flow|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145624|NCT01381575|P2|Participant Flow|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145710|NCT01381016|P2|Participant Flow|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145625|NCT01381575|P1|Participant Flow|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145626|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145627|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145628|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145629|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145630|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145631|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145632|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145633|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145634|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145635|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145636|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145637|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145638|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145639|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145640|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145641|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145642|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145643|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145644|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145645|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145646|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145647|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145648|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145649|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145650|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145651|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145652|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145653|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145654|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145655|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145656|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145657|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145658|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145659|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145660|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145661|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145662|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145663|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145664|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145665|NCT01381575|O1|Outcome|Cervarix1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145666|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145667|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145668|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145669|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145670|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145671|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145672|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145673|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145674|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145675|NCT01381575|E3|Reported Event|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145676|NCT01381575|E2|Reported Event|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145677|NCT01381575|E1|Reported Event|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
145678|NCT01381471|B1|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
145679|NCT01381471|P1|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
145680|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
145681|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
145682|NCT01381471|E1|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
145683|NCT01381406|B3|Baseline|Total|Total of all reporting groups
145684|NCT01381406|B2|Baseline|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145685|NCT01381406|B1|Baseline|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
145686|NCT01381406|P2|Participant Flow|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145687|NCT01381406|P1|Participant Flow|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period
145688|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145689|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
145690|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145691|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
145692|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145693|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
145694|NCT01381406|E2|Reported Event|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
145695|NCT01381406|E1|Reported Event|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
145696|NCT01381120|B3|Baseline|Total|Total of all reporting groups
145697|NCT01381120|B2|Baseline|Narcotic Painkiller|
145698|NCT01381120|B1|Baseline|VESIcare + Narcotic Painkiller|
145699|NCT01381120|P2|Participant Flow|Narcotic Painkiller|
145700|NCT01381120|P1|Participant Flow|VESIcare + Narcotic Painkiller|
145701|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
145702|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
145703|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
145704|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
145705|NCT01381120|E2|Reported Event|Narcotic Painkiller|
145706|NCT01381120|E1|Reported Event|VESIcare + Narcotic Painkiller|
145707|NCT01381016|B3|Baseline|Total|Total of all reporting groups
145708|NCT01381016|B2|Baseline|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145709|NCT01381016|B1|Baseline|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145711|NCT01381016|P1|Participant Flow|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145712|NCT01381016|O2|Outcome|Experimental|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145713|NCT01381016|O1|Outcome|Control|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145714|NCT01381016|O2|Outcome|Group 2 - Obese|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145715|NCT01381016|O1|Outcome|Group 1 - Normal Weight|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145716|NCT01381016|E2|Reported Event|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145717|NCT01381016|E1|Reported Event|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
145718|NCT01380834|B3|Baseline|Total|Total of all reporting groups
145719|NCT01380834|B2|Baseline|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145720|NCT01380834|B1|Baseline|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145721|NCT01380834|P2|Participant Flow|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145722|NCT01380834|P1|Participant Flow|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145723|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145724|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145725|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145726|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145727|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145728|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145729|NCT01380834|E2|Reported Event|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
145730|NCT01380834|E1|Reported Event|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
145731|NCT01380782|B3|Baseline|Total|Total of all reporting groups
145732|NCT01380782|B2|Baseline|Arm B Bevacizumab-treated|Bevacizumab-treated participants
145733|NCT01380782|B1|Baseline|Arm A Bevacizumab-naive|Bevacizumab-naive participants
145734|NCT01380782|P4|Participant Flow|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
145735|NCT01380782|P3|Participant Flow|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
145736|NCT01380782|P2|Participant Flow|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
146921|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
145737|NCT01380782|P1|Participant Flow|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
145738|NCT01380782|O2|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
145739|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
145740|NCT01380782|O1|Outcome|All Participants (Arm A and B)|
145741|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
145742|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
145743|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
145744|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
145745|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
145746|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
145747|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
145748|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
145749|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
145750|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
145751|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
145752|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
145753|NCT01380782|O1|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
145754|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
145755|NCT01380782|E2|Reported Event|Arm B|Bevacizumab-treated participants
145756|NCT01380782|E1|Reported Event|Arm A|Bevacizumab-naive participants
145757|NCT01380730|B9|Baseline|Total|Total of all reporting groups
145758|NCT01380730|B8|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145759|NCT01380730|B7|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145760|NCT01380730|B6|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145761|NCT01380730|B5|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145762|NCT01380730|B4|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145763|NCT01380730|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145764|NCT01380730|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145765|NCT01380730|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145766|NCT01380730|P8|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145767|NCT01380730|P7|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145768|NCT01380730|P6|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145769|NCT01380730|P5|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145770|NCT01380730|P4|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145771|NCT01380730|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145772|NCT01380730|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145773|NCT01380730|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145774|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145775|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145776|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145777|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
146922|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
145778|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145779|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145780|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145781|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145782|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145783|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145784|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145785|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145786|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145787|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145788|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145789|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145790|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145791|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145792|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145793|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145794|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145795|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145796|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145797|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145798|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145799|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145800|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145801|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145802|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145803|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145804|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145805|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145806|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145807|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145808|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145809|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145810|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145811|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145812|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145813|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145814|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145815|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145816|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145817|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145818|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145819|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145820|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145821|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145822|NCT01380730|E8|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145823|NCT01380730|E7|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145824|NCT01380730|E6|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
145825|NCT01380730|E5|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145826|NCT01380730|E4|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145827|NCT01380730|E3|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
145828|NCT01380730|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
145829|NCT01380730|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
145830|NCT01380639|B3|Baseline|Total|Total of all reporting groups
145831|NCT01380639|B2|Baseline|Rehabilitation Without Vibration Training|
145832|NCT01380639|B1|Baseline|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
145833|NCT01380639|P2|Participant Flow|Rehabilitation Without Vibration Training|
145834|NCT01380639|P1|Participant Flow|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
145835|NCT01380639|O2|Outcome|Rehabilitation Without Vibration Training|
145836|NCT01380639|O1|Outcome|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
145837|NCT01380639|E2|Reported Event|Rehabilitation Without Vibration Training|
145838|NCT01380639|E1|Reported Event|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
145839|NCT01380379|B1|Baseline|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
145840|NCT01380379|P1|Participant Flow|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
145841|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
145842|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
145843|NCT01380379|E1|Reported Event|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
145844|NCT01380366|B1|Baseline|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
145845|NCT01380366|P1|Participant Flow|Zorptive Subjects|Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
145846|NCT01380366|O1|Outcome|Patient Decreased Liver Injury|Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
145847|NCT01380366|O1|Outcome|Patients Experiencing Decrease in Concentration of Sucralose|A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
145848|NCT01380366|E1|Reported Event|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
145849|NCT01380327|B4|Baseline|Total|Total of all reporting groups
145850|NCT01380327|B3|Baseline|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145851|NCT01380327|B2|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145943|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145944|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145852|NCT01380327|B1|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145853|NCT01380327|P3|Participant Flow|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145854|NCT01380327|P2|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145855|NCT01380327|P1|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145856|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145857|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145858|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145859|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145860|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145861|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145862|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145863|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145864|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145865|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
146293|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
145866|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145867|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145868|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145869|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145870|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145871|NCT01380327|E3|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
145872|NCT01380327|E2|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
145873|NCT01380327|E1|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
145874|NCT01379183|B3|Baseline|Total|Total of all reporting groups
145875|NCT01379183|B2|Baseline|Placebo|Matching placebo i.v. suspension
145876|NCT01379183|B1|Baseline|Erythromycin|Erythromycin 200 mg i.v. suspension
145877|NCT01379183|P2|Participant Flow|Placebo|Matching placebo i.v. suspension
145878|NCT01379183|P1|Participant Flow|Erythromycin|Erythromycin 200 mg i.v. suspension
145879|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
145880|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
145881|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
145882|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
145883|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
145884|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
145885|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
145886|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
145887|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
145888|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
145889|NCT01379183|O2|Outcome|Placebo|Matching placebo i.v. suspension
145890|NCT01379183|O1|Outcome|Erythromycin|Erythromycin 200 mg i.v. suspension
145891|NCT01379183|E2|Reported Event|Placebo|Matching placebo i.v. suspension
145892|NCT01379183|E1|Reported Event|Erythromycin|Erythromycin 200 mg i.v. suspension
145893|NCT01380197|B3|Baseline|Total|Total of all reporting groups
145894|NCT01380197|B2|Baseline|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145895|NCT01380197|B1|Baseline|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145896|NCT01380197|P2|Participant Flow|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145897|NCT01380197|P1|Participant Flow|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145898|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145899|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145900|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145901|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145902|NCT01380197|E2|Reported Event|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145903|NCT01380197|E1|Reported Event|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
145904|NCT01380145|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in the study.
145905|NCT01380145|P1|Participant Flow|All Enrolled Subjects|Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
145906|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
145907|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
145908|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
145909|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
145910|NCT01380145|O1|Outcome|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
145911|NCT01380145|E1|Reported Event|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
145912|NCT01380093|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
145913|NCT01380093|P9|Participant Flow|EMBEDA Then Placebo Then Morphine|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145914|NCT01380093|P8|Participant Flow|Placebo Then Morphine Then EMBEDA|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145915|NCT01380093|P7|Participant Flow|Morphine Then EMBEDA Then Placebo|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145945|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145946|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
155109|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
145916|NCT01380093|P6|Participant Flow|Morphine Then Placebo Then EMBEDA|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145917|NCT01380093|P5|Participant Flow|EMBEDA Then Morphine Then Placebo|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145918|NCT01380093|P4|Participant Flow|Placebo Then EMBEDA Then Morphine|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
145919|NCT01380093|P3|Participant Flow|Placebo Then Morphine|Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
145920|NCT01380093|P2|Participant Flow|Morphine Then Placebo|Single dose of morphine sulfate 120 mg solution orally on Day 1 followed by single dose of matching placebo solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
145921|NCT01380093|P1|Participant Flow|Naloxone|Naloxone hydrochloride 0.2 milligram (mg) intravenously (IV) followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal. Participants in this group were assigned to either morphine then placebo or placebo then morphine in the drug discrimination phase of the study.
145922|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145923|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145924|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145925|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145926|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145927|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145928|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145929|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145930|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145931|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145932|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145933|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145934|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145935|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145936|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145937|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145938|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145939|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145940|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145941|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145942|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145985|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145947|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145948|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145949|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145950|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145951|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145952|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145953|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145954|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145955|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145956|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145957|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145958|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145959|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145960|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145961|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145962|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145963|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145964|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145965|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145966|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145967|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145968|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145969|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145970|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145971|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145972|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145973|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145974|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145975|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145976|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145977|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145978|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145979|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145980|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145981|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145982|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145983|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145984|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
157284|NCT01335789|B3|Baseline|Total|Total of all reporting groups
145986|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145987|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145988|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145989|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145990|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145991|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145992|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145993|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145994|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145995|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145996|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
145997|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
145998|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
145999|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146000|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146001|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146002|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146003|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146004|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146005|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146006|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146007|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146008|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146009|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146010|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146011|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146012|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146013|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146014|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146015|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146016|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146017|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146018|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146019|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146020|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146021|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146022|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146023|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146024|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
157813|NCT01333592|E2|Reported Event|KAD-1229 / Biguanides|
146025|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146026|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146027|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146028|NCT01380093|O2|Outcome|EMBEDA|Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.
146029|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146030|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146031|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146032|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146033|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146034|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146035|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146036|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146037|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146038|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146039|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146040|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146041|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146042|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146043|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146044|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146045|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146046|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146047|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146048|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146049|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146050|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146051|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146052|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146053|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146054|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146055|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146056|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146057|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146058|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146059|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146060|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146061|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146062|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146063|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
157814|NCT01333592|E1|Reported Event|KAD-1229 / DPP-4 Inhibitors|
146064|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146065|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146066|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146067|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146068|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146069|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146070|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146071|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146072|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146073|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146074|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146075|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146076|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146077|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146078|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146079|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146080|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146081|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146082|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146083|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146084|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146085|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146086|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146087|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146088|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146089|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146090|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146091|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146092|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146093|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146094|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146095|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146096|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146097|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146098|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146099|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146100|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146101|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146102|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
157815|NCT01333488|B4|Baseline|Total|Total of all reporting groups
146103|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146104|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146105|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146106|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146107|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146108|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146109|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146110|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146111|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146112|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146113|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146114|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146115|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146116|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146117|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146118|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146119|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146120|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146121|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146122|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146123|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146124|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146125|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146126|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146127|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146128|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146129|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146130|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146131|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146132|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146133|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146134|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146135|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146136|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146137|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146138|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146139|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146140|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146141|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
160606|NCT01323673|B3|Baseline|Total|Total of all reporting groups
146142|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146143|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146144|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146145|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146146|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146147|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146148|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146149|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146150|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146151|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146152|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146153|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146154|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146155|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146156|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146157|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146158|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146159|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146160|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146161|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146162|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146163|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146164|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146165|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146166|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146167|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146168|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146169|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146170|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146171|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146172|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146173|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146174|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146175|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146176|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146177|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146178|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146179|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146180|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
161020|NCT01322594|E4|Reported Event|MEDI2338 100 MG|
146181|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146182|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146183|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146184|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146185|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146186|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146187|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146188|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146189|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146190|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146191|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146192|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146193|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146194|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146195|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146196|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146197|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146198|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146199|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146200|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146201|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146202|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146203|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146204|NCT01380093|E6|Reported Event|Morphine (Treatment Phase)|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
146205|NCT01380093|E5|Reported Event|EMBEDA (Treatment Phase)|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
146206|NCT01380093|E4|Reported Event|Placebo (Treatment Phase)|Single dose of matching placebo solution orally in either of the first to third intervention periods.
146207|NCT01380093|E3|Reported Event|Morphine (Drug Discrimination Phase)|Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.
146208|NCT01380093|E2|Reported Event|Placebo (Drug Discrimination Phase)|Single dose of matching placebo solution orally on Day 1 or 2.
146209|NCT01380093|E1|Reported Event|Naloxone (Naloxone Challenge Phase)|Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.
146210|NCT01380080|B3|Baseline|Total|Total of all reporting groups
146211|NCT01380080|B2|Baseline|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146212|NCT01380080|B1|Baseline|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146241|NCT01379937|P2|Participant Flow|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146608|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146213|NCT01380080|P2|Participant Flow|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146214|NCT01380080|P1|Participant Flow|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146215|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146216|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146217|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146218|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146219|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146220|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146221|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146222|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146242|NCT01379937|P1|Participant Flow|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146609|NCT01378195|E2|Reported Event|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146223|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146224|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146225|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146226|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146227|NCT01380080|E2|Reported Event|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
146228|NCT01380080|E1|Reported Event|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
146229|NCT01379963|B1|Baseline|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
146230|NCT01379963|P1|Participant Flow|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
146231|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
146232|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
146233|NCT01379963|E1|Reported Event|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
146234|NCT01379937|B5|Baseline|Total|Total of all reporting groups
146235|NCT01379937|B4|Baseline|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146236|NCT01379937|B3|Baseline|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146237|NCT01379937|B2|Baseline|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146238|NCT01379937|B1|Baseline|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146239|NCT01379937|P4|Participant Flow|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146240|NCT01379937|P3|Participant Flow|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146243|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146244|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146245|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146246|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146247|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146248|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146249|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146250|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146251|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146252|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146253|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146254|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146255|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146256|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146257|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146258|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146259|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146260|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
146261|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146262|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146263|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146264|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146265|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146266|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146267|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
161021|NCT01322594|E3|Reported Event|MEDI2338 30 MG|
146268|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146269|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146270|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146271|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146272|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146273|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146274|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146275|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146276|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146277|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146278|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146279|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146280|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146281|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
146282|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146283|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146284|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146285|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146286|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146287|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146288|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146289|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146290|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146291|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146292|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146610|NCT01378195|E1|Reported Event|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146294|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146295|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146296|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146297|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146298|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146299|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146300|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146301|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146302|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146303|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146304|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146305|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146306|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146307|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146308|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146309|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146310|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146311|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146312|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146313|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146314|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146315|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146316|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146317|NCT01379937|E4|Reported Event|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146318|NCT01379937|E3|Reported Event|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146319|NCT01379937|E2|Reported Event|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146320|NCT01379937|E1|Reported Event|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
146321|NCT01379781|B3|Baseline|Total|Total of all reporting groups
146322|NCT01379781|B2|Baseline|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146323|NCT01379781|B1|Baseline|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146324|NCT01379781|P2|Participant Flow|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146325|NCT01379781|P1|Participant Flow|Behavioral Intervention for Postpartum Depression|"Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.~Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146326|NCT01379781|O2|Outcome|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146327|NCT01379781|O1|Outcome|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146328|NCT01379781|E2|Reported Event|Treatment As Usual|Referred to Treatment in the Community.
146329|NCT01379781|E1|Reported Event|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
146330|NCT01379768|B4|Baseline|Total|Total of all reporting groups
146331|NCT01379768|B3|Baseline|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146332|NCT01379768|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146333|NCT01379768|B1|Baseline|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146334|NCT01379768|P3|Participant Flow|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146335|NCT01379768|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146336|NCT01379768|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146337|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146338|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146339|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146340|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146341|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146342|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146343|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146344|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146377|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146345|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146346|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146347|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146348|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146349|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146350|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146351|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146352|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146353|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146354|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146355|NCT01379768|E3|Reported Event|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
146356|NCT01379768|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146357|NCT01379768|E1|Reported Event|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
146358|NCT01379703|B1|Baseline|Total Study Population|HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
146359|NCT01379703|P3|Participant Flow|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146360|NCT01379703|P2|Participant Flow|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146361|NCT01379703|P1|Participant Flow|Tablets and Capsules or Oral Solution|HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
146362|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146363|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146364|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146365|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146366|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146367|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146368|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146369|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146370|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146371|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146372|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146373|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146374|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146375|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146376|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146378|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146379|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146380|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146381|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146382|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146383|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146384|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146385|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146386|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146387|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146388|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146389|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146390|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146391|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146392|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146393|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146394|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146395|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146396|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146397|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146398|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146399|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146400|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146401|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146402|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
146403|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146404|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146405|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146406|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146407|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146408|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146409|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146410|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146411|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146412|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146413|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146560|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146414|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146415|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146416|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146417|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146418|NCT01379703|E3|Reported Event|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
146419|NCT01379703|E2|Reported Event|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
146420|NCT01379703|E1|Reported Event|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
146421|NCT01379651|B3|Baseline|Total|Total of all reporting groups
146422|NCT01379651|B2|Baseline|Control|controls were kept on an egg-free diet for 6 months
146423|NCT01379651|B1|Baseline|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
146424|NCT01379651|P2|Participant Flow|Control|controls were kept on an egg-free diet for 6 months
146425|NCT01379651|P1|Participant Flow|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
146426|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
146427|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
146428|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
146429|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
146430|NCT01379651|E2|Reported Event|Control|controls were kept on an egg-free diet for 6 months
146431|NCT01379651|E1|Reported Event|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
146432|NCT01379534|B3|Baseline|Total|Total of all reporting groups
146433|NCT01379534|B2|Baseline|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146434|NCT01379534|B1|Baseline|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146435|NCT01379534|P2|Participant Flow|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146436|NCT01379534|P1|Participant Flow|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146437|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146438|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146439|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146440|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146441|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146442|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146443|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146444|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146445|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146446|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146447|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146448|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146449|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146611|NCT01378117|B4|Baseline|Total|Total of all reporting groups
146450|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146451|NCT01379534|E2|Reported Event|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146452|NCT01379534|E1|Reported Event|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
146453|NCT01378988|B3|Baseline|Total|Total of all reporting groups
146454|NCT01378988|B2|Baseline|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146455|NCT01378988|B1|Baseline|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146456|NCT01378988|P2|Participant Flow|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146457|NCT01378988|P1|Participant Flow|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146458|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146459|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146460|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146461|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146462|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146463|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146464|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146465|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146466|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146467|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146468|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146469|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146470|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146471|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146472|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146473|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146474|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146475|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146476|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146477|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146478|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146479|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146480|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
146481|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
146482|NCT01378988|E2|Reported Event|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose
146483|NCT01378988|E1|Reported Event|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose
146484|NCT01378975|B3|Baseline|Total|Total of all reporting groups
146485|NCT01378975|B2|Baseline|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146486|NCT01378975|B1|Baseline|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146487|NCT01378975|P2|Participant Flow|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146488|NCT01378975|P1|Participant Flow|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146489|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146490|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146491|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146492|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146493|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146494|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146495|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146496|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146497|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146498|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146499|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146500|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146561|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
161022|NCT01322594|E2|Reported Event|MEDI2338 10 MG|
146501|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146502|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146503|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146504|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146505|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146506|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146507|NCT01378975|O1|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146508|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146509|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146510|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146511|NCT01378975|E2|Reported Event|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146512|NCT01378975|E1|Reported Event|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
146513|NCT01378962|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146514|NCT01378962|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146515|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146516|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146517|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146518|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146519|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146520|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146521|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146522|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146523|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146524|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146525|NCT01378962|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
146526|NCT01378520|B1|Baseline|Entire Study Population|Includes groups randomized to receive Ketoconazole first and inert powder first.
146527|NCT01378520|P2|Participant Flow|First Inert Powder, Then Ketoconazole|Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
146528|NCT01378520|P1|Participant Flow|First Ketoconazole, Then Inert Powder|Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
146529|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
146530|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
146531|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
146532|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
146533|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
146534|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
146535|NCT01378520|E2|Reported Event|Inert Powder|Inert powder (in capsule taken orally)
146536|NCT01378520|E1|Reported Event|Ketoconazole|Ketoconazole(600 mg taken orally)
146537|NCT01378429|B3|Baseline|Total|Total of all reporting groups
146538|NCT01378429|B2|Baseline|Ciclesonide Nasal Aerosol (74 mcg)|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146539|NCT01378429|B1|Baseline|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146540|NCT01378429|P2|Participant Flow|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
146541|NCT01378429|P1|Participant Flow|Placebo|Placebo: Placebo
146542|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146543|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146544|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
146545|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
146546|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146547|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146548|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146549|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146550|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146551|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146552|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146553|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146554|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146555|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146556|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
146557|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
146558|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146559|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
161023|NCT01322594|E1|Reported Event|Placebo|
146562|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146563|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146564|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
146565|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
146566|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146567|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146568|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
146569|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
146570|NCT01378429|E2|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
146571|NCT01378429|E1|Reported Event|Placebo|Placebo: Placebo
146572|NCT01378416|B1|Baseline|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146573|NCT01378416|P1|Participant Flow|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146574|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146575|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146576|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146577|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146578|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146579|NCT01378416|E1|Reported Event|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
146580|NCT01378325|B3|Baseline|Total|Total of all reporting groups
146581|NCT01378325|B2|Baseline|Phenylephrine|PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
146582|NCT01378325|B1|Baseline|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
146583|NCT01378325|P2|Participant Flow|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
146584|NCT01378325|P1|Participant Flow|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
146585|NCT01378325|O2|Outcome|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
146586|NCT01378325|O1|Outcome|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
146587|NCT01378325|E2|Reported Event|Phenylephrine|Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
146588|NCT01378325|E1|Reported Event|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
146589|NCT01378221|B3|Baseline|Total|Total of all reporting groups
146590|NCT01378221|B2|Baseline|Group 2|cardiac surgery patients aged 75 years and over
146591|NCT01378221|B1|Baseline|Group 1|cardiac surgery patients age 65 years and less
146592|NCT01378221|P2|Participant Flow|Group 2|cardiac surgery patients aged 75 years and over
146593|NCT01378221|P1|Participant Flow|Group 1|cardiac surgery patients age 65 years and less
146594|NCT01378221|O2|Outcome|Group 2|cardiac surgery patients aged 75 years and over
146595|NCT01378221|O1|Outcome|Group 1|cardiac surgery patients age 65 years and less
146596|NCT01378221|E2|Reported Event|Group 2|cardiac surgery patients aged 75 years and over
146597|NCT01378221|E1|Reported Event|Group 1|cardiac surgery patients age 65 years and less
146598|NCT01378195|B3|Baseline|Total|Total of all reporting groups
146599|NCT01378195|B2|Baseline|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146600|NCT01378195|B1|Baseline|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146601|NCT01378195|P2|Participant Flow|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146602|NCT01378195|P1|Participant Flow|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146603|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146604|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146605|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146606|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
146607|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
146612|NCT01378117|B3|Baseline|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
146613|NCT01378117|B2|Baseline|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
146614|NCT01378117|B1|Baseline|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
146615|NCT01378117|P3|Participant Flow|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
146616|NCT01378117|P2|Participant Flow|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
146617|NCT01378117|P1|Participant Flow|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
146618|NCT01378117|O3|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
146619|NCT01378117|O2|Outcome|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
146620|NCT01378117|O1|Outcome|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
146621|NCT01378117|E3|Reported Event|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
146622|NCT01378117|E2|Reported Event|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
146623|NCT01378117|E1|Reported Event|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
146624|NCT01378104|B3|Baseline|Total|Total of all reporting groups
146625|NCT01378104|B2|Baseline|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
146626|NCT01378104|B1|Baseline|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
146627|NCT01378104|P2|Participant Flow|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
146628|NCT01378104|P1|Participant Flow|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
146629|NCT01378104|O2|Outcome|The Patients With Unfavourable IL28B Genotype|These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.
146630|NCT01378104|O1|Outcome|Favourable IL28B Genotype|These group patients show the IL28B rs12979860CC and rs8099917TT.
146631|NCT01378104|O2|Outcome|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
146632|NCT01378104|O1|Outcome|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
146633|NCT01378104|E2|Reported Event|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
146634|NCT01378104|E1|Reported Event|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
146635|NCT01378065|B1|Baseline|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146636|NCT01378065|P1|Participant Flow|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146637|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146699|NCT01377623|E2|Reported Event|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146638|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146639|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146640|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146641|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146642|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146643|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146644|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146645|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146646|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146647|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146648|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146649|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146650|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146651|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146652|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146653|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146654|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146655|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146656|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146657|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146658|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146659|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146660|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146661|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146662|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146663|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146664|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146665|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146666|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146700|NCT01377623|E1|Reported Event|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146667|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146668|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146669|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146670|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146671|NCT01378065|E1|Reported Event|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
146672|NCT01377636|B1|Baseline|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146673|NCT01377636|P1|Participant Flow|Pre and Post Isoproterenol Infusion|Bispectral EEG (BIS) monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
146674|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146675|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146676|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146677|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
146678|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146679|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
146680|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
146681|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
146682|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|BIS monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
146683|NCT01377636|E1|Reported Event|Pre and Post Isoproterenol Infusion|In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
146684|NCT01377623|B3|Baseline|Total|Total of all reporting groups
146685|NCT01377623|B2|Baseline|Dexmedetomidine Group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
146686|NCT01377623|B1|Baseline|Placebo Group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
146687|NCT01377623|P2|Participant Flow|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146688|NCT01377623|P1|Participant Flow|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146689|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146690|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146691|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146692|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146693|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146694|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146695|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146696|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146697|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
146698|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
146701|NCT01377480|B5|Baseline|Total|Total of all reporting groups
146702|NCT01377480|B4|Baseline|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
146703|NCT01377480|B3|Baseline|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
146704|NCT01377480|B2|Baseline|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
146705|NCT01377480|B1|Baseline|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
146706|NCT01377480|P4|Participant Flow|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
146707|NCT01377480|P3|Participant Flow|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
146708|NCT01377480|P2|Participant Flow|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
146709|NCT01377480|P1|Participant Flow|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
146710|NCT01377480|O4|Outcome|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
146711|NCT01377480|O3|Outcome|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
146712|NCT01377480|O2|Outcome|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
146713|NCT01377480|O1|Outcome|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
146714|NCT01377480|E4|Reported Event|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
146715|NCT01377480|E3|Reported Event|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
146716|NCT01377480|E2|Reported Event|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
146717|NCT01377480|E1|Reported Event|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
146718|NCT01377467|B3|Baseline|Total|Total of all reporting groups
146719|NCT01377467|B2|Baseline|Control|No treatment
146720|NCT01377467|B1|Baseline|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146721|NCT01377467|P2|Participant Flow|Control|No treatment
146722|NCT01377467|P1|Participant Flow|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146723|NCT01377467|O2|Outcome|Control|No treatment
146724|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146725|NCT01377467|O2|Outcome|Control|No treatment
146726|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146727|NCT01377467|O2|Outcome|Control|No treatment
146728|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146729|NCT01377467|O2|Outcome|Control|No treatment
146730|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146731|NCT01377467|O2|Outcome|Control|No treatment
146732|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146733|NCT01377467|O2|Outcome|Control|No treatment
146734|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146735|NCT01377467|O2|Outcome|Control|No treatment
146736|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146737|NCT01377467|O2|Outcome|Control|No treatment
146738|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146739|NCT01377467|O2|Outcome|Control|No treatment
146740|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146741|NCT01377467|O2|Outcome|Control|No treatment
146742|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146743|NCT01377467|O2|Outcome|Control|No treatment
146744|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146745|NCT01377467|O2|Outcome|Control|No treatment
146746|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146747|NCT01377467|O2|Outcome|Control|No treatment
146748|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146749|NCT01377467|O2|Outcome|Control|No treatment
146750|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146751|NCT01377467|O2|Outcome|Control|No treatment
146752|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146753|NCT01377467|O2|Outcome|Control|No treatment
146754|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146755|NCT01377467|O2|Outcome|Control|No treatment
146756|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146758|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146759|NCT01377467|O2|Outcome|Control|No treatment
146760|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146761|NCT01377467|O2|Outcome|Control|No treatment
146762|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146763|NCT01377467|O2|Outcome|Control|No treatment
146764|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146765|NCT01377467|E2|Reported Event|Control|No treatment
146766|NCT01377467|E1|Reported Event|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
146767|NCT01377441|B3|Baseline|Total|Total of all reporting groups
146768|NCT01377441|B2|Baseline|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
146769|NCT01377441|B1|Baseline|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
146770|NCT01377441|P2|Participant Flow|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
146771|NCT01377441|P1|Participant Flow|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
146772|NCT01377441|O2|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
146773|NCT01377441|O1|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
146774|NCT01377441|E2|Reported Event|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
146775|NCT01377441|E1|Reported Event|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
146776|NCT01377402|B1|Baseline|Patients With Suspected Acute Coronary Chest Pain|Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
146777|NCT01377402|P1|Participant Flow|Patients With Suspected Acute Coronary Chest Pain|Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
146778|NCT01377402|O1|Outcome|Patients With Suspected ACS|Patients with acute hospitalisation due to suspected coronary chest pain.
146779|NCT01377402|E1|Reported Event|Patients With Suspected ACS|Patients admitted to hospital with acute chest pain.
146780|NCT01377233|B6|Baseline|Total|Total of all reporting groups
146781|NCT01377233|B5|Baseline|Zicronapine 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146782|NCT01377233|B4|Baseline|Zicronapine 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146783|NCT01377233|B3|Baseline|Zicronapine 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146784|NCT01377233|B2|Baseline|Zicronapine 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146785|NCT01377233|B1|Baseline|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
146786|NCT01377233|P5|Participant Flow|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146787|NCT01377233|P4|Participant Flow|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146788|NCT01377233|P3|Participant Flow|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146789|NCT01377233|P2|Participant Flow|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146790|NCT01377233|P1|Participant Flow|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
146791|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146792|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146793|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146794|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146795|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146796|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146797|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146798|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146799|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146800|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146801|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146802|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146803|NCT01377233|O5|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146804|NCT01377233|O4|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146805|NCT01377233|O3|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146806|NCT01377233|O2|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146807|NCT01377233|O1|Outcome|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
146808|NCT01377233|E5|Reported Event|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146809|NCT01377233|E4|Reported Event|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146810|NCT01377233|E3|Reported Event|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
146811|NCT01377233|E2|Reported Event|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
146812|NCT01377233|E1|Reported Event|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
146813|NCT01377194|B4|Baseline|Total|Total of all reporting groups
146814|NCT01377194|B3|Baseline|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
146815|NCT01377194|B2|Baseline|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
146816|NCT01377194|B1|Baseline|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
146817|NCT01377194|P3|Participant Flow|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
146818|NCT01377194|P2|Participant Flow|Levomilnacipran ER 40 mg|40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
146819|NCT01377194|P1|Participant Flow|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
146820|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
146821|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
146822|NCT01377194|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
146823|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks
146824|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.
146825|NCT01377194|O1|Outcome|Placebo|Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.
146826|NCT01377194|E3|Reported Event|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
146827|NCT01377194|E2|Reported Event|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
146828|NCT01377194|E1|Reported Event|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
146829|NCT01376908|B3|Baseline|Total|Total of all reporting groups
146830|NCT01376908|B2|Baseline|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146831|NCT01376908|B1|Baseline|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146832|NCT01376908|P2|Participant Flow|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146845|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. After 26 weeks, the starting dose of Kuvan will be 10 mg/kg/day, and the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
146833|NCT01376908|P1|Participant Flow|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146834|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146835|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146836|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146837|NCT01376908|O3|Outcome|Population PK Analysis Set: Age Group 2 (>= 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146838|NCT01376908|O2|Outcome|Population PK Analysis Set: Age Group 2 (1 to 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146839|NCT01376908|O1|Outcome|Population PK Analysis Set: Age Group 1 (< 1 Year)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146840|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146841|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146842|NCT01376908|O1|Outcome|Pharmacogenetic Evaluation|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146843|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146844|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146846|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.After 26 weeks, the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
146847|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146848|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146849|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146850|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146851|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146852|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146853|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146854|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146855|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146856|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146857|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146858|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146859|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146860|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146861|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146862|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146863|NCT01376908|E2|Reported Event|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146864|NCT01376908|E1|Reported Event|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
146865|NCT01376804|B1|Baseline|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146915|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146916|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146866|NCT01376804|P1|Participant Flow|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146867|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146868|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146869|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146870|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146871|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146872|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146873|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146874|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146875|NCT01376804|E1|Reported Event|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
146876|NCT01376700|B1|Baseline|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
146877|NCT01376700|P1|Participant Flow|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
146878|NCT01376700|O2|Outcome|MTPs|≤4 previous FVIII exposures
146879|NCT01376700|O1|Outcome|PUPs|No previous FVIII exposure
146880|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
146881|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146882|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146883|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146884|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146917|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146918|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146919|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146920|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146885|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146886|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146887|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146888|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146889|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146890|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146891|NCT01376700|E1|Reported Event|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
146892|NCT01376557|B6|Baseline|Total|Total of all reporting groups
146893|NCT01376557|B5|Baseline|Placebo qd|Placebo: Subjects will receive placebo once daily.
146894|NCT01376557|B4|Baseline|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146895|NCT01376557|B3|Baseline|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146896|NCT01376557|B2|Baseline|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146897|NCT01376557|B1|Baseline|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146898|NCT01376557|P5|Participant Flow|Placebo qd|Placebo: Subjects will receive placebo once daily.
146899|NCT01376557|P4|Participant Flow|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146900|NCT01376557|P3|Participant Flow|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146901|NCT01376557|P2|Participant Flow|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146902|NCT01376557|P1|Participant Flow|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146903|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146904|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146905|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146906|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146907|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146908|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146909|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146910|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146911|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146912|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146913|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146914|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146923|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146924|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146925|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146926|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146927|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146928|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
146929|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146930|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146931|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146932|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146933|NCT01376557|E5|Reported Event|Placebo qd|Placebo: Subjects will receive placebo once daily.
146934|NCT01376557|E4|Reported Event|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
146935|NCT01376557|E3|Reported Event|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
146936|NCT01376557|E2|Reported Event|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
146937|NCT01376557|E1|Reported Event|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
146938|NCT01376388|B1|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146939|NCT01376388|P1|Participant Flow|UMEC/VI 125/25 µg|Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
146940|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146941|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146942|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146943|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146944|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146945|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146946|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146947|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146948|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146949|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146950|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146951|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
146952|NCT01376388|E1|Reported Event|GSK573719/GW642444|125/25mcg
146953|NCT01376362|B1|Baseline|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146954|NCT01376362|P1|Participant Flow|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146955|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146956|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146957|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146958|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146959|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146960|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146961|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146962|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146963|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146964|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146965|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146966|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146967|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146968|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146969|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146970|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146971|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146972|NCT01376362|E1|Reported Event|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
146973|NCT01376297|B3|Baseline|Total|Total of all reporting groups
146974|NCT01376297|B2|Baseline|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
146975|NCT01376297|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
146976|NCT01376297|P2|Participant Flow|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
146977|NCT01376297|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
147007|NCT01376089|P2|Participant Flow|Arm 2-Iopamidol|Subjects were injected with Iopamidol (Isovue).
161024|NCT01322386|B3|Baseline|Total|Total of all reporting groups
146978|NCT01376297|O2|Outcome|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
146979|NCT01376297|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
146980|NCT01376297|E2|Reported Event|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
146981|NCT01376297|E1|Reported Event|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
146982|NCT01376245|B5|Baseline|Total|Total of all reporting groups
146983|NCT01376245|B4|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146984|NCT01376245|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146985|NCT01376245|B2|Baseline|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146986|NCT01376245|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
146987|NCT01376245|P5|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146988|NCT01376245|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146989|NCT01376245|P3|Participant Flow|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146990|NCT01376245|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
146991|NCT01376245|P1|Participant Flow|Placebo- Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
146992|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146993|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146994|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146995|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
146996|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146997|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146998|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
146999|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
147000|NCT01376245|E4|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
147001|NCT01376245|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
147002|NCT01376245|E2|Reported Event|FF/VI 50/25 µg OD|articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
147003|NCT01376245|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
147004|NCT01376089|B3|Baseline|Total|Total of all reporting groups
147005|NCT01376089|B2|Baseline|Arm 2-Iopamidol|
147006|NCT01376089|B1|Baseline|Arm 1-Iodixanol|
147008|NCT01376089|P1|Participant Flow|Arm 1-Iodixanol|Subjects were injected with Iodixanol (Visipaque).
147009|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
147010|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
147011|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
147012|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
147013|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue)|Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
147014|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque)|Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
147015|NCT01376089|E2|Reported Event|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
147016|NCT01376089|E1|Reported Event|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
147017|NCT01376050|B3|Baseline|Total|Total of all reporting groups
147018|NCT01376050|B2|Baseline|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
147019|NCT01376050|B1|Baseline|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
147020|NCT01376050|P2|Participant Flow|Placebo Laser|Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
147021|NCT01376050|P1|Participant Flow|Erchonia ML Scanner (MLS)|Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
147022|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
147023|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
147024|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
147025|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
147026|NCT01376050|E2|Reported Event|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
147027|NCT01376050|E1|Reported Event|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
147028|NCT01376037|B3|Baseline|Total|Total of all reporting groups
147029|NCT01376037|B2|Baseline|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
147030|NCT01376037|B1|Baseline|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
147031|NCT01376037|P2|Participant Flow|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
147032|NCT01376037|P1|Participant Flow|Erchonia ML Scanner (MLS)|The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
147033|NCT01376037|O2|Outcome|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
147069|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147070|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147071|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147034|NCT01376037|O1|Outcome|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
147035|NCT01376037|E2|Reported Event|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
147036|NCT01376037|E1|Reported Event|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
147037|NCT01375777|B10|Baseline|Total|Total of all reporting groups
147038|NCT01375777|B9|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147039|NCT01375777|B8|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147040|NCT01375777|B7|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147041|NCT01375777|B6|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147042|NCT01375777|B5|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147043|NCT01375777|B4|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147044|NCT01375777|B3|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147045|NCT01375777|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147046|NCT01375777|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147047|NCT01375777|P9|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147048|NCT01375777|P8|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147049|NCT01375777|P7|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147050|NCT01375777|P6|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147051|NCT01375777|P5|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147052|NCT01375777|P4|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147053|NCT01375777|P3|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147054|NCT01375777|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147055|NCT01375777|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147056|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147057|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147058|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147059|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147060|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147061|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147062|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147063|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147064|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147065|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147066|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147067|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147068|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147072|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147073|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147074|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147075|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147076|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147077|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147078|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147079|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147080|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147081|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147082|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147083|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147084|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147085|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147086|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147087|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147088|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147089|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147090|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147091|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147092|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147093|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147094|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147095|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147096|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147097|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147098|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147099|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147100|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147101|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147102|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147103|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147104|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147105|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147106|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147107|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147108|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147109|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147110|NCT01375777|E9|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147111|NCT01375777|E8|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147112|NCT01375777|E7|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147113|NCT01375777|E6|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147114|NCT01375777|E5|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147115|NCT01375777|E4|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
147116|NCT01375777|E3|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
147117|NCT01375777|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
147118|NCT01375777|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
147120|NCT01375764|B5|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147121|NCT01375764|B4|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147122|NCT01375764|B3|Baseline|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147123|NCT01375764|B2|Baseline|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147124|NCT01375764|B1|Baseline|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147125|NCT01375764|P5|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147126|NCT01375764|P4|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147127|NCT01375764|P3|Participant Flow|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147128|NCT01375764|P2|Participant Flow|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147129|NCT01375764|P1|Participant Flow|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147130|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147131|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147132|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147133|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147134|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147135|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147136|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147137|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147138|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147139|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147140|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147141|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147142|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147143|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147144|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147145|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147146|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147147|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147148|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147149|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147150|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147151|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147152|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147153|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147154|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147155|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147156|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147157|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147158|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147159|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147160|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147161|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147320|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147162|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147163|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147164|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147165|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147166|NCT01375764|E5|Reported Event|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147167|NCT01375764|E4|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147168|NCT01375764|E3|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147169|NCT01375764|E2|Reported Event|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147170|NCT01375764|E1|Reported Event|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
147171|NCT01375751|B4|Baseline|Total|Total of all reporting groups
147172|NCT01375751|B3|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147173|NCT01375751|B2|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147174|NCT01375751|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147175|NCT01375751|P3|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147176|NCT01375751|P2|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147177|NCT01375751|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147178|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147179|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147180|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147181|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147182|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147183|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147184|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147185|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147186|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147187|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147188|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147189|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147190|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147191|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147192|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147193|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147194|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147195|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147196|NCT01375751|E3|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147197|NCT01375751|E2|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
147198|NCT01375751|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
147199|NCT01375660|B3|Baseline|Total|Total of all reporting groups
147200|NCT01375660|B2|Baseline|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147201|NCT01375660|B1|Baseline|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147202|NCT01375660|P2|Participant Flow|50K Vitamin D2|supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
147203|NCT01375660|P1|Participant Flow|Placebo|supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147204|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147205|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147206|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147207|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147208|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147209|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147210|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147211|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147212|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147213|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147214|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147215|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
147216|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
147217|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
147218|NCT01375660|E2|Reported Event|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
147219|NCT01375660|E1|Reported Event|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
147220|NCT01375569|B1|Baseline|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
147221|NCT01375569|P1|Participant Flow|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
147222|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
147223|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
147224|NCT01375569|E1|Reported Event|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
147225|NCT01375374|B1|Baseline|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147226|NCT01375374|P1|Participant Flow|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147227|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147228|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147229|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147230|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147231|NCT01375374|E1|Reported Event|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
147232|NCT01375127|B7|Baseline|Total|Total of all reporting groups
147316|NCT01374451|P1|Participant Flow|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147233|NCT01375127|B6|Baseline|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147234|NCT01375127|B5|Baseline|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147235|NCT01375127|B4|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147236|NCT01375127|B3|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147237|NCT01375127|B2|Baseline|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147238|NCT01375127|B1|Baseline|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147239|NCT01375127|P6|Participant Flow|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147240|NCT01375127|P5|Participant Flow|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147241|NCT01375127|P4|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147242|NCT01375127|P3|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147243|NCT01375127|P2|Participant Flow|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147244|NCT01375127|P1|Participant Flow|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147245|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147246|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147247|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147248|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147249|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147250|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147251|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147252|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147317|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147253|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147254|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147255|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147256|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147257|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147258|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147259|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147260|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147261|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147262|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147263|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147264|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147265|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147266|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147267|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147268|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147269|NCT01375127|E6|Reported Event|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147270|NCT01375127|E5|Reported Event|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147271|NCT01375127|E4|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147272|NCT01375127|E3|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147318|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
161212|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
147273|NCT01375127|E2|Reported Event|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
147274|NCT01375127|E1|Reported Event|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
147275|NCT01375049|B1|Baseline|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147276|NCT01375049|P1|Participant Flow|AZLI|Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147277|NCT01375049|O1|Outcome|AZLI - Sensitivity Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Sensitivity Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a PA-positive culture from Day 28 through Day 196 or used any additional antipseudomonal antibiotics from Day 28 through Day 196."
147278|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147279|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147280|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147281|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147282|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147283|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
147284|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
147285|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
147286|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
147287|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
147288|NCT01375049|O1|Outcome|AZLI - Evaluable Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196."
147289|NCT01375049|E1|Reported Event|AZLI|"Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
147290|NCT01374971|B1|Baseline|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
147319|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147291|NCT01374971|P1|Participant Flow|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
147292|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
147293|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
147294|NCT01374971|E1|Reported Event|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
147295|NCT01374919|B1|Baseline|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
147296|NCT01374919|P1|Participant Flow|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
147297|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
147298|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
147299|NCT01374919|E1|Reported Event|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
147300|NCT01374802|B1|Baseline|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: faldaprevir together with DRV/r."
147301|NCT01374802|P1|Participant Flow|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: Faldaprevir together with DRV/r."
147302|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
147303|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
147304|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
147305|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
147306|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
147307|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
147308|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
147309|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
147310|NCT01374802|E2|Reported Event|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
147311|NCT01374802|E1|Reported Event|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily
147312|NCT01374451|B3|Baseline|Total|Total of all reporting groups
147313|NCT01374451|B2|Baseline|Everolimus|everolimus 10 mg once daily po alone
147314|NCT01374451|B1|Baseline|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147315|NCT01374451|P2|Participant Flow|Everolimus|everolimus 10 mg once daily po alone
147321|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147322|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147323|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147324|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147325|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147326|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147327|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147328|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147329|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147330|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147331|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147332|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147333|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147334|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147335|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147336|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147337|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147338|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
147339|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147340|NCT01374451|E2|Reported Event|Everolimus|everolimus 10 mg once daily po alone
147341|NCT01374451|E1|Reported Event|Everolimus LAR + Pasireotide|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
147342|NCT01374438|B3|Baseline|Total|Total of all reporting groups
147343|NCT01374438|B2|Baseline|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147344|NCT01374438|B1|Baseline|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147345|NCT01374438|P2|Participant Flow|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147346|NCT01374438|P1|Participant Flow|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147347|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147348|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147349|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147350|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147351|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147352|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147353|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147354|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147355|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147356|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147357|NCT01374438|E2|Reported Event|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
147358|NCT01374438|E1|Reported Event|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
147359|NCT01374425|B3|Baseline|Total|Total of all reporting groups
147360|NCT01374425|B2|Baseline|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147361|NCT01374425|B1|Baseline|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147595|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
161213|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
147362|NCT01374425|P2|Participant Flow|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147363|NCT01374425|P1|Participant Flow|Bevacizumab + mFOLFOX6|Participants with untreated metastatic colorectal cancer (mCRC) who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 milligrams per kilogram (mg/kg), leucovorin as 400 milligrams per meter-squared (mg/m^2), oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via intravenous (IV) infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147364|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147365|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147366|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147367|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147368|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147369|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147453|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147370|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
147371|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
147372|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147373|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147374|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
147375|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
147376|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147377|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147705|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147706|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147378|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
147379|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
147380|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147381|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147382|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147383|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147384|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147385|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147596|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147386|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147387|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147388|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147389|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147390|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147391|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147392|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147393|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147394|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147395|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147396|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147397|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147398|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147399|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147400|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147401|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147402|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147403|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147404|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147692|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147405|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147406|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147407|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147408|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147409|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147410|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147411|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147412|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147413|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147693|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147414|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147415|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147416|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147417|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147418|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147419|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147420|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147421|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147422|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147465|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147423|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147424|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147425|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147426|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147427|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
147428|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
147429|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 picograms per milliliter (pg/mL) at Baseline were included in separate analyses.
147430|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147477|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
148680|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
147431|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147432|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147433|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level less than or equal to (≤) 1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147434|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
147435|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level greater than (>) 1.7 × 10^-3 ERCC-1/B-actin messenger ribonucleic acid (mRNA) at Baseline were included in separate analyses.
147436|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147437|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147438|NCT01374425|E2|Reported Event|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147439|NCT01374425|E1|Reported Event|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
147440|NCT01374269|B3|Baseline|Total|Total of all reporting groups
147441|NCT01374269|B2|Baseline|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147442|NCT01374269|B1|Baseline|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147443|NCT01374269|P2|Participant Flow|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147444|NCT01374269|P1|Participant Flow|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147445|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147446|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147447|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147448|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147449|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147450|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147451|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147452|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147694|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
148681|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
147454|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147455|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147456|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147457|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147458|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147459|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147460|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147461|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147462|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147463|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147464|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147695|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147466|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147467|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147468|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147469|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147470|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147471|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147472|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147473|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147474|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147475|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147476|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147696|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147478|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147479|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147480|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147481|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147482|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147483|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147484|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147485|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147486|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147487|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147488|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147697|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
148682|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
147489|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147490|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147491|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147492|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147493|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147494|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147495|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147496|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147497|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147498|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147499|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147511|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147500|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147501|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147502|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147503|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147504|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147505|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147506|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147507|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147508|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147509|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147510|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147698|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147512|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147513|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147514|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147515|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147516|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147517|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147518|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147519|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147520|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147521|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147522|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147699|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147523|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147524|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147525|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147526|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147527|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147528|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147529|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147530|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147531|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147532|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147533|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147545|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147534|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147535|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147536|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147537|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147538|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147539|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147540|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147541|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147542|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147543|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147544|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147700|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
148683|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
147546|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147547|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147548|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147549|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147550|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147551|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147552|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147553|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147554|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147555|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147556|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147701|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147557|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147558|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147559|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147560|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147561|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147562|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147563|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147564|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147565|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147566|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147567|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147594|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
148132|NCT01371721|E2|Reported Event|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
147568|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147569|NCT01374269|E2|Reported Event|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
147570|NCT01374269|E1|Reported Event|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
147571|NCT01374178|B1|Baseline|Entire Study Population|"For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).~For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours)."
147572|NCT01374178|P2|Participant Flow|Lantus First, Then LY2963016|A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
147573|NCT01374178|P1|Participant Flow|LY2963016 First, Then Lantus|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
147574|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147575|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147576|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147577|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147578|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147579|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147580|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147581|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147582|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147583|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147584|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147585|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147586|NCT01374178|E2|Reported Event|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
147587|NCT01374178|E1|Reported Event|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
147588|NCT01373918|B3|Baseline|Total|Total of all reporting groups
147589|NCT01373918|B2|Baseline|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147590|NCT01373918|B1|Baseline|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147591|NCT01373918|P2|Participant Flow|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147592|NCT01373918|P1|Participant Flow|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147593|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147702|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147597|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147598|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147599|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147600|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147601|NCT01373918|E2|Reported Event|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147602|NCT01373918|E1|Reported Event|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
147603|NCT01373671|B1|Baseline|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
147604|NCT01373671|P1|Participant Flow|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
147605|NCT01373671|O2|Outcome|FFDM Only|FFDM exam only
147606|NCT01373671|O1|Outcome|FFDM and DBT|FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration
147607|NCT01373671|E1|Reported Event|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
147608|NCT01373450|B1|Baseline|All Treated Participants|
147609|NCT01373450|P6|Participant Flow|Pbo--> Lg-0.6--> OXM--> Lg-1.2|Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
147610|NCT01373450|P5|Participant Flow|OXM--> Pbo--> Lg-0.6--> Pbo|Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
147611|NCT01373450|P4|Participant Flow|Lg-0.6--> OXM--> Pbo--> Lg-1.2|Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
147612|NCT01373450|P3|Participant Flow|Pbo--> OXM--> Lg-0.6-->Pbo|Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
147613|NCT01373450|P2|Participant Flow|Lg-0.6 mg--> Pbo--> OXM--> Pbo|Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
147614|NCT01373450|P1|Participant Flow|OXM --> Lg-0.6--> Pbo--> Lg-1.2|Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
147615|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147616|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147617|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
147618|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
147619|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147620|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147621|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
147622|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
147623|NCT01373450|O2|Outcome|Placebo Period 2|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147624|NCT01373450|O1|Outcome|Placebo Period 1|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147625|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147626|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147627|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147628|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147629|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147630|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147631|NCT01373450|E4|Reported Event|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
147632|NCT01373450|E3|Reported Event|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
147633|NCT01373450|E2|Reported Event|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
147634|NCT01373450|E1|Reported Event|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
147635|NCT01373346|B1|Baseline|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
147636|NCT01373346|P1|Participant Flow|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
147703|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
148212|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
147637|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147638|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147639|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147640|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147641|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147642|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147643|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147644|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
147645|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.~Until end of study (on average 14.8 months), operation related mortality of Gastric cancer patient with type 2 diabetes who receive total or Subtotal gastrectomy with long limb Roux en Y reconstruction were analyzed."
147646|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147647|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147648|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147649|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147650|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147704|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
148213|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
147651|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147652|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147653|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Morbidity after operation were analyzed until end of study (on average 14.8 months)
147654|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
147655|NCT01373346|E1|Reported Event|Long-limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
147656|NCT01373294|B3|Baseline|Total|Total of all reporting groups
147657|NCT01373294|B2|Baseline|B: Control Arm|Bacille Calmette-Guerrin (BCG).
147658|NCT01373294|B1|Baseline|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
147659|NCT01373294|P2|Participant Flow|B: Control Arm|Bacille Calmette-Guerrin (BCG).
147660|NCT01373294|P1|Participant Flow|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
147661|NCT01373294|O2|Outcome|B: Control Arm|Bacille Calmette-Guerrin (BCG).
147662|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
147663|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
147664|NCT01373294|E2|Reported Event|B: Control Arm|Bacille Calmette-Guerrin (BCG).
147665|NCT01373294|E1|Reported Event|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
147666|NCT01373281|B3|Baseline|Total|Total of all reporting groups
147667|NCT01373281|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147668|NCT01373281|B1|Baseline|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147669|NCT01373281|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147670|NCT01373281|P1|Participant Flow|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147671|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147672|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147673|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147674|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147675|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147676|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147677|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147678|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147679|NCT01373281|O2|Outcome|Placebo Group|Subset of subjects who received at least one dose of the placebo vaccine.
147680|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subset of subjects who received at least one dose of CYD Dengue vaccine.
147681|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
147682|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
147683|NCT01373281|E2|Reported Event|Placebo Group|Safety data were collected in subjects that received at least 1 dose of placebo vaccine.
147684|NCT01373281|E1|Reported Event|CYD Dengue Vaccine Group|Safety data were collected in subjects that received at least 1 dose of CYD dengue vaccine.
147685|NCT01372995|B4|Baseline|Total|Total of all reporting groups
147686|NCT01372995|B3|Baseline|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147687|NCT01372995|B2|Baseline|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147688|NCT01372995|B1|Baseline|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147689|NCT01372995|P3|Participant Flow|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147690|NCT01372995|P2|Participant Flow|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147691|NCT01372995|P1|Participant Flow|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
148684|NCT01369745|O5|Outcome|Placebo|placebo once daily
147707|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147708|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147709|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147710|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147711|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147712|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147713|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147714|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147715|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147716|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147717|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147718|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147719|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147720|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147721|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147722|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147723|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147724|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147725|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147726|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147727|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147728|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147729|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147730|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147731|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
147732|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
147733|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147734|NCT01372995|E3|Reported Event|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
147735|NCT01372995|E2|Reported Event|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.
147736|NCT01372995|E1|Reported Event|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
147737|NCT01372878|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
147738|NCT01372878|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
147739|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
147740|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
147741|NCT01372878|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
147800|NCT01372462|B1|Baseline|Overall Study Group|Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
162022|NCT01317667|B4|Baseline|Total|Total of all reporting groups
147742|NCT01372813|B1|Baseline|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147743|NCT01372813|P1|Participant Flow|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147744|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147745|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147746|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147747|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147748|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147749|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147750|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147751|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147752|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147753|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147754|NCT01372813|E1|Reported Event|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
147755|NCT01372748|B3|Baseline|Total|Total of all reporting groups
147756|NCT01372748|B2|Baseline|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
147757|NCT01372748|B1|Baseline|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
147758|NCT01372748|P2|Participant Flow|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
148133|NCT01371721|E1|Reported Event|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
147759|NCT01372748|P1|Participant Flow|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
147760|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
147761|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
147762|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
147763|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
147764|NCT01372748|E2|Reported Event|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
147765|NCT01372748|E1|Reported Event|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
147766|NCT01372605|B3|Baseline|Total|Total of all reporting groups
147767|NCT01372605|B2|Baseline|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147768|NCT01372605|B1|Baseline|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147769|NCT01372605|P2|Participant Flow|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147770|NCT01372605|P1|Participant Flow|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147771|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147772|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147773|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147774|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147775|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147776|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147777|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147881|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147778|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147779|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147780|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147781|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147782|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147783|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147784|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147785|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147786|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147787|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147788|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147789|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147790|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147791|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147792|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147793|NCT01372605|E2|Reported Event|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
147794|NCT01372605|E1|Reported Event|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
147795|NCT01372501|B1|Baseline|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
147796|NCT01372501|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
147797|NCT01372501|O1|Outcome|EndoBarrier Liner Device|Endobarrier Liner: Medical device placed endoscopically in the duodenum
147798|NCT01372501|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
147799|NCT01372501|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
148134|NCT01371708|B4|Baseline|Total|Total of all reporting groups
147801|NCT01372462|P1|Participant Flow|All Study Participants|"All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.~Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen."
147802|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
147803|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
147804|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
147805|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
147806|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
147807|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
147808|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
147809|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
147810|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
147811|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
147812|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
147813|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
147814|NCT01372462|E4|Reported Event|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
147815|NCT01372462|E3|Reported Event|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
147816|NCT01372462|E2|Reported Event|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
147817|NCT01372462|E1|Reported Event|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
147818|NCT01372410|B1|Baseline|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147819|NCT01372410|P8|Participant Flow|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147820|NCT01372410|P7|Participant Flow|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147821|NCT01372410|P6|Participant Flow|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147822|NCT01372410|P5|Participant Flow|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147823|NCT01372410|P4|Participant Flow|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147824|NCT01372410|P3|Participant Flow|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147912|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147913|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147825|NCT01372410|P2|Participant Flow|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147826|NCT01372410|P1|Participant Flow|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147827|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147828|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147829|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147830|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147831|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147832|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147833|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147834|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147835|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147836|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147837|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147838|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147839|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147840|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147841|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147842|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147843|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147844|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147845|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147846|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147847|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147848|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147849|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147850|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147851|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147852|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147853|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147854|NCT01372410|E8|Reported Event|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147855|NCT01372410|E7|Reported Event|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147856|NCT01372410|E6|Reported Event|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147857|NCT01372410|E5|Reported Event|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147858|NCT01372410|E4|Reported Event|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
148207|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
147859|NCT01372410|E3|Reported Event|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147860|NCT01372410|E2|Reported Event|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147861|NCT01372410|E1|Reported Event|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
147862|NCT01372384|B1|Baseline|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147863|NCT01372384|P1|Participant Flow|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147864|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147865|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147866|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147867|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147868|NCT01372384|E1|Reported Event|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
147869|NCT01372150|B4|Baseline|Total|Total of all reporting groups
147870|NCT01372150|B3|Baseline|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147871|NCT01372150|B2|Baseline|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
147872|NCT01372150|B1|Baseline|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147873|NCT01372150|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release (DVS SR)|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147874|NCT01372150|P2|Participant Flow|Fluoxetine|Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
147875|NCT01372150|P1|Participant Flow|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147876|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147877|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
147878|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147879|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147880|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
148208|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
147882|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147883|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
147884|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147885|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147886|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
147887|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147888|NCT01372150|E3|Reported Event|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
147889|NCT01372150|E2|Reported Event|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
147890|NCT01372150|E1|Reported Event|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
147891|NCT01371994|B3|Baseline|Total|Total of all reporting groups
147892|NCT01371994|B2|Baseline|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147893|NCT01371994|B1|Baseline|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147894|NCT01371994|P2|Participant Flow|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147895|NCT01371994|P1|Participant Flow|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147896|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147897|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147898|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147899|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147900|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147901|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147902|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147903|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147904|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147905|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147906|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147907|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147908|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147909|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147910|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147911|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
148685|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
147914|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147915|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147916|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147917|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147918|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147919|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147920|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147921|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147922|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147923|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147924|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147925|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147926|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147927|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147928|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147929|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147930|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147931|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147932|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147933|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147934|NCT01371994|E2|Reported Event|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
147935|NCT01371994|E1|Reported Event|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
147936|NCT01371877|B3|Baseline|Total|Total of all reporting groups
147937|NCT01371877|B2|Baseline|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147938|NCT01371877|B1|Baseline|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147939|NCT01371877|P2|Participant Flow|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147940|NCT01371877|P1|Participant Flow|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147941|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147942|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147943|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147944|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147945|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147946|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147947|NCT01371877|E2|Reported Event|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
147948|NCT01371877|E1|Reported Event|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
147949|NCT01371851|B3|Baseline|Total|Total of all reporting groups
147982|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147950|NCT01371851|B2|Baseline|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147951|NCT01371851|B1|Baseline|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147952|NCT01371851|P2|Participant Flow|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147953|NCT01371851|P1|Participant Flow|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147954|NCT01371851|O2|Outcome|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147955|NCT01371851|O1|Outcome|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147956|NCT01371851|E2|Reported Event|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147957|NCT01371851|E1|Reported Event|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
147958|NCT01371838|B3|Baseline|Total|Total of all reporting groups
147959|NCT01371838|B2|Baseline|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147960|NCT01371838|B1|Baseline|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147961|NCT01371838|P2|Participant Flow|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147962|NCT01371838|P1|Participant Flow|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147963|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147964|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147965|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147966|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147967|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147968|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147969|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147970|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147971|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147972|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147973|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147974|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147975|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147976|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147977|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147978|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147979|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147980|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147981|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
148209|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
147983|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147984|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147985|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147986|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147987|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147988|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147989|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147990|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147991|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147992|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147993|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147994|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147995|NCT01371838|E2|Reported Event|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
147996|NCT01371838|E1|Reported Event|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
147997|NCT01371825|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
147998|NCT01371825|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
147999|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148000|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148001|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148002|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148025|NCT01371786|E1|Reported Event|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148026|NCT01371747|B7|Baseline|Total|Total of all reporting groups
148027|NCT01371747|B6|Baseline|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148210|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148003|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148004|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148005|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148006|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148007|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148008|NCT01371825|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
148009|NCT01371786|B3|Baseline|Total|Total of all reporting groups
148010|NCT01371786|B2|Baseline|Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148011|NCT01371786|B1|Baseline|Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148012|NCT01371786|P2|Participant Flow|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148013|NCT01371786|P1|Participant Flow|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148014|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148015|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148016|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148017|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148018|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148019|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148020|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148021|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148022|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148023|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
148024|NCT01371786|E2|Reported Event|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
148028|NCT01371747|B5|Baseline|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day
148029|NCT01371747|B4|Baseline|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148030|NCT01371747|B3|Baseline|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148031|NCT01371747|B2|Baseline|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148032|NCT01371747|B1|Baseline|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148033|NCT01371747|P6|Participant Flow|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148034|NCT01371747|P5|Participant Flow|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148035|NCT01371747|P4|Participant Flow|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148036|NCT01371747|P3|Participant Flow|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148037|NCT01371747|P2|Participant Flow|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148038|NCT01371747|P1|Participant Flow|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148039|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148040|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148041|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148042|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148043|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148044|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148045|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148046|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148047|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148048|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148049|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148050|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day
148051|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148052|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148053|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148054|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148055|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148056|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148057|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148058|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148059|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148060|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148061|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148062|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148063|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148064|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148065|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148066|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148067|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148068|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148069|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148070|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148071|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148072|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148073|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148074|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148075|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148076|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148077|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148078|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148079|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148080|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148081|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148082|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148083|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148084|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148085|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148086|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148087|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148088|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148089|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148090|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148091|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148092|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148093|NCT01371747|E6|Reported Event|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
148686|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
148094|NCT01371747|E5|Reported Event|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148095|NCT01371747|E4|Reported Event|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148096|NCT01371747|E3|Reported Event|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
148097|NCT01371747|E2|Reported Event|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
148098|NCT01371747|E1|Reported Event|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
148099|NCT01371721|B4|Baseline|Total|Total of all reporting groups
148100|NCT01371721|B3|Baseline|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148101|NCT01371721|B2|Baseline|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148102|NCT01371721|B1|Baseline|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148103|NCT01371721|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148104|NCT01371721|P2|Participant Flow|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148105|NCT01371721|P1|Participant Flow|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148106|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148107|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148108|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148109|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148110|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148111|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148112|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148113|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148114|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148115|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148116|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148117|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148118|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148119|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148120|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148121|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148122|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148123|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148124|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148125|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148126|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148127|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148128|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148129|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148130|NCT01371721|E4|Reported Event|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148131|NCT01371721|E3|Reported Event|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
148211|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148135|NCT01371708|B3|Baseline|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148136|NCT01371708|B2|Baseline|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148137|NCT01371708|B1|Baseline|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148138|NCT01371708|P3|Participant Flow|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148139|NCT01371708|P2|Participant Flow|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148140|NCT01371708|P1|Participant Flow|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148141|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148142|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148143|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148144|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148145|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148146|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148147|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148148|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148149|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148150|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148151|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148152|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148153|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148154|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148155|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148156|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148157|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148158|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148159|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148160|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148161|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
148162|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148163|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148687|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
148164|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148165|NCT01371708|E4|Reported Event|Combination Group|Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148166|NCT01371708|E3|Reported Event|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148167|NCT01371708|E2|Reported Event|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148168|NCT01371708|E1|Reported Event|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
148169|NCT01371643|B3|Baseline|Total|Total of all reporting groups
148170|NCT01371643|B2|Baseline|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148171|NCT01371643|B1|Baseline|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148172|NCT01371643|P2|Participant Flow|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148173|NCT01371643|P1|Participant Flow|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148174|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148175|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148176|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148177|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148178|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148179|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148180|NCT01371643|E2|Reported Event|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
148181|NCT01371643|E1|Reported Event|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
148182|NCT01371565|B1|Baseline|Mifepristone|At doses from 300mg/day up to 1200mg/day
148183|NCT01371565|P1|Participant Flow|Mifepristone|At doses from 300mg/day up to 1200mg/day
148184|NCT01371565|O1|Outcome|Mifepristone|At doses from 300mg/day up to 1200mg/day
148185|NCT01371565|E1|Reported Event|Mifepristone|At doses from 300mg/day up to 1200mg/day
148186|NCT01371552|B1|Baseline|Overall Study|This reporting group includes all enrolled participants.
148187|NCT01371552|P6|Participant Flow|Filcon II 3 / Delefilcon A / Narafilcon A|Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
148188|NCT01371552|P5|Participant Flow|Narafilcon A / Delefilcon A / Filcon II 3|Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
148189|NCT01371552|P4|Participant Flow|Delefilcon A / Narafilcon A / Filcon II 3|Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
148190|NCT01371552|P3|Participant Flow|Filcon II 3 / Narafilcon A / Delefilcon A|Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
148191|NCT01371552|P2|Participant Flow|Narafilcon A / Filcon II 3 / Delefilcon A|Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
148192|NCT01371552|P1|Participant Flow|Delefilcon A / Filcon II 3 / Narafilcon A|Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
148193|NCT01371552|O1|Outcome|Delefilcon A - All Wearers|Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
148194|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148195|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148196|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148197|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148198|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148199|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148200|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148201|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148202|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148203|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148204|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148205|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148206|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148214|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148215|NCT01371552|E3|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148216|NCT01371552|E2|Reported Event|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
148217|NCT01371552|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
148218|NCT01371539|B1|Baseline|Overall|All enrolled and dispensed participants
148219|NCT01371539|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
148220|NCT01371539|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
148221|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
148222|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
148223|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
148224|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
148225|NCT01371539|E2|Reported Event|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
148226|NCT01371539|E1|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
148227|NCT01371006|B3|Baseline|Total|Total of all reporting groups
148228|NCT01371006|B2|Baseline|Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148229|NCT01371006|B1|Baseline|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148230|NCT01371006|P2|Participant Flow|Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148231|NCT01371006|P1|Participant Flow|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148232|NCT01371006|O5|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
148233|NCT01371006|O4|Outcome|Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
148234|NCT01371006|O3|Outcome|Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam.
148235|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
148236|NCT01371006|O1|Outcome|Midazolam|Treatment with single-dose Midazolam.
148237|NCT01371006|O4|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
148238|NCT01371006|O3|Outcome|Efavirenz+Faldaprevir|During treatment with Faldaprevir and single-dose Efavirenz.
148239|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
148240|NCT01371006|O1|Outcome|Efavirenz|Treatment with single-dose Efavirenz.
148241|NCT01371006|O2|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148242|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148243|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148244|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148245|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148246|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
148247|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148248|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148688|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
148249|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148250|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148251|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
148252|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
148253|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
148254|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
148255|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
148256|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
148257|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
148258|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
148259|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
148260|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
148261|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
148262|NCT01371006|E7|Reported Event|Group B: Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
148263|NCT01371006|E6|Reported Event|Group B: Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam in Group B.
148264|NCT01371006|E5|Reported Event|Group B: Faldaprevir|During treatment with Faldaprevir in Group B.
148265|NCT01371006|E4|Reported Event|Group B: Midazolam|Treatment with single-dose Midazolam in Group B.
148266|NCT01371006|E3|Reported Event|Group A: Faldaprevir+Efavirenz|During treatment with Faldaprevir and single-dose Efavirenz in Group A.
148267|NCT01371006|E2|Reported Event|Group A: Faldaprevir|During treatment with Faldaprevir in Group A.
148268|NCT01371006|E1|Reported Event|Group A: Efavirenz|Treatment with single-dose Efavirenz in Group A.
148269|NCT01370863|B3|Baseline|Total|Total of all reporting groups
148270|NCT01370863|B2|Baseline|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
148271|NCT01370863|B1|Baseline|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148272|NCT01370863|P2|Participant Flow|Placebo|Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment
148273|NCT01370863|P1|Participant Flow|SPD557|0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148274|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
148275|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148276|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
148277|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148278|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
148279|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148280|NCT01370863|E2|Reported Event|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
148281|NCT01370863|E1|Reported Event|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
148282|NCT01370837|B4|Baseline|Total|Total of all reporting groups
148283|NCT01370837|B3|Baseline|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148284|NCT01370837|B2|Baseline|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148285|NCT01370837|B1|Baseline|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148306|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148286|NCT01370837|P3|Participant Flow|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148287|NCT01370837|P2|Participant Flow|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148288|NCT01370837|P1|Participant Flow|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148289|NCT01370837|O3|Outcome|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148290|NCT01370837|O2|Outcome|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148291|NCT01370837|O1|Outcome|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148292|NCT01370837|E3|Reported Event|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148293|NCT01370837|E2|Reported Event|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148294|NCT01370837|E1|Reported Event|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
148295|NCT01370733|B3|Baseline|Total|Total of all reporting groups
148296|NCT01370733|B2|Baseline|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148297|NCT01370733|B1|Baseline|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148298|NCT01370733|P2|Participant Flow|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148299|NCT01370733|P1|Participant Flow|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148300|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148301|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148302|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148303|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148304|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148305|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148359|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148307|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148308|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148309|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148310|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148311|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148312|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148313|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148314|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148315|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148316|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148317|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148318|NCT01370733|E2|Reported Event|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
148319|NCT01370733|E1|Reported Event|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
148320|NCT01370694|B1|Baseline|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148321|NCT01370694|P1|Participant Flow|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148322|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148323|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148324|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148325|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148326|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148360|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148689|NCT01369745|E5|Reported Event|Placebo|placebo once daily
148327|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148328|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148329|NCT01370694|E1|Reported Event|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
148330|NCT01370642|B4|Baseline|Total|Total of all reporting groups
148331|NCT01370642|B3|Baseline|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148332|NCT01370642|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148333|NCT01370642|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148334|NCT01370642|P3|Participant Flow|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148335|NCT01370642|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148336|NCT01370642|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148337|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148338|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148339|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148340|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148341|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148342|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148343|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148344|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148345|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148346|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148347|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148348|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148349|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148350|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148351|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148352|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148353|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148354|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148355|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148356|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148357|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148358|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148361|NCT01370642|E3|Reported Event|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
148362|NCT01370642|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
148363|NCT01370642|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
148364|NCT01370616|B3|Baseline|Total|Total of all reporting groups
148365|NCT01370616|B2|Baseline|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148366|NCT01370616|B1|Baseline|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148367|NCT01370616|P2|Participant Flow|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148368|NCT01370616|P1|Participant Flow|Ertapenem Sodium|Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148369|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148370|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148371|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148372|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148373|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148374|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148375|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148376|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148377|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148378|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148379|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148380|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148381|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148382|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
162023|NCT01317667|B3|Baseline|Group 3|RVEc vaccine 100 μg/dose x 1 dose
148383|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148384|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148385|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148386|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148387|NCT01370616|E2|Reported Event|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148388|NCT01370616|E1|Reported Event|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
148389|NCT01370603|B3|Baseline|Total|Total of all reporting groups
148390|NCT01370603|B2|Baseline|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
148391|NCT01370603|B1|Baseline|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
148392|NCT01370603|P2|Participant Flow|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
148393|NCT01370603|P1|Participant Flow|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
148394|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148395|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148396|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148397|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148398|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148399|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148400|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148401|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148402|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148403|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148404|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
148405|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148406|NCT01370603|E2|Reported Event|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks
148407|NCT01370603|E1|Reported Event|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
148408|NCT01370590|B3|Baseline|Total|Total of all reporting groups
148409|NCT01370590|B2|Baseline|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
148410|NCT01370590|B1|Baseline|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
148411|NCT01370590|P2|Participant Flow|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
148412|NCT01370590|P1|Participant Flow|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
148413|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148414|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148415|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148416|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148417|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148418|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148419|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148420|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148421|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148422|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148423|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148424|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148425|NCT01370590|E2|Reported Event|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
148426|NCT01370590|E1|Reported Event|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
148427|NCT01370538|B3|Baseline|Total|Total of all reporting groups
148428|NCT01370538|B2|Baseline|Placebo|Placebo for Esomeprazole
148429|NCT01370538|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148430|NCT01370538|P2|Participant Flow|Placebo|Placebo for Esomeprazole
148431|NCT01370538|P1|Participant Flow|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148432|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
148433|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148434|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
148435|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148436|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
148437|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148438|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
148439|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148440|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
148441|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148442|NCT01370538|E2|Reported Event|Placebo|Placebo for Esomeprazole
148443|NCT01370538|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148444|NCT01370525|B3|Baseline|Total|Total of all reporting groups
148445|NCT01370525|B2|Baseline|Placebo|Placebo for Esomeprazole
148446|NCT01370525|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148447|NCT01370525|P2|Participant Flow|Placebo|Placebo for Esomeprazole
148448|NCT01370525|P1|Participant Flow|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
148449|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
148450|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148451|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
148452|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148453|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
148454|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148455|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
148456|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148457|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
148458|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148459|NCT01370525|E2|Reported Event|Placebo|Placebo for Esomeprazole
148460|NCT01370525|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
148461|NCT01370460|B3|Baseline|Total|Total of all reporting groups
148462|NCT01370460|B2|Baseline|Placebo|100mL 0.9% NS, applied topically
148463|NCT01370460|B1|Baseline|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
148464|NCT01370460|P2|Participant Flow|Placebo|100mL 0.9% NS, applied topically
148465|NCT01370460|P1|Participant Flow|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
148466|NCT01370460|O2|Outcome|Placebo|100mL 0.9% NS, applied topically
148467|NCT01370460|O1|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
148468|NCT01370460|O2|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
148469|NCT01370460|O1|Outcome|Placebo|100mL 0.9% NS, applied topically
148470|NCT01370460|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
148471|NCT01370408|B1|Baseline|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148472|NCT01370408|P1|Participant Flow|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148473|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148474|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148475|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148476|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148477|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148478|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148479|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148480|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148481|NCT01370408|E1|Reported Event|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
148482|NCT01370356|B3|Baseline|Total|Total of all reporting groups
148483|NCT01370356|B2|Baseline|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
148484|NCT01370356|B1|Baseline|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population.
148485|NCT01370356|P2|Participant Flow|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
148486|NCT01370356|P1|Participant Flow|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population.
148487|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148488|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148489|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148532|NCT01370005|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148533|NCT01370005|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148490|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148491|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148492|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148493|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148494|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148495|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148496|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148497|NCT01370356|E2|Reported Event|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
148498|NCT01370356|E1|Reported Event|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
148499|NCT01370265|B1|Baseline|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
148500|NCT01370265|P2|Participant Flow|Adenosine, Then Regadenoson|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
148501|NCT01370265|P1|Participant Flow|Regadenoson, Then Adenosine|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148502|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148503|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148504|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148505|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148506|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148507|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148508|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148509|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148510|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148511|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148512|NCT01370265|O1|Outcome|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
148513|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148514|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148515|NCT01370265|E2|Reported Event|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
148516|NCT01370265|E1|Reported Event|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
148517|NCT01370083|B3|Baseline|Total|Total of all reporting groups
148534|NCT01370005|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148535|NCT01370005|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148518|NCT01370083|B2|Baseline|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148519|NCT01370083|B1|Baseline|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148520|NCT01370083|P2|Participant Flow|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148521|NCT01370083|P1|Participant Flow|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148522|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148523|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148524|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148525|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148526|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148527|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148528|NCT01370083|E2|Reported Event|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
148529|NCT01370083|E1|Reported Event|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
148530|NCT01370005|B4|Baseline|Total|Total of all reporting groups
148531|NCT01370005|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148536|NCT01370005|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148537|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148538|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148539|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148540|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148541|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148542|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148543|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148544|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148545|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148546|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148547|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148548|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148549|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148550|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148551|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148552|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148553|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148554|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148555|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148556|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148557|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148558|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148559|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148560|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148561|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148562|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148563|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148564|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148565|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148566|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148567|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148568|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148569|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148570|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148571|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148572|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148573|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148574|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148575|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148576|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148577|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148578|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148579|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148580|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148581|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148582|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148583|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148584|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148585|NCT01370005|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
148586|NCT01370005|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
148587|NCT01370005|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
148588|NCT01369888|B5|Baseline|Total|Total of all reporting groups
148589|NCT01369888|B4|Baseline|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148590|NCT01369888|B3|Baseline|IL-15 Following Young TIL (10.50 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148591|NCT01369888|B2|Baseline|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148592|NCT01369888|B1|Baseline|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148593|NCT01369888|P4|Participant Flow|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148594|NCT01369888|P3|Participant Flow|IL-15 Following Young TIL (1 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148595|NCT01369888|P2|Participant Flow|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148596|NCT01369888|P1|Participant Flow|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148597|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148598|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148599|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148600|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148601|NCT01369888|E2|Reported Event|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148602|NCT01369888|E1|Reported Event|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
148603|NCT01369875|B3|Baseline|Total|Total of all reporting groups
148604|NCT01369875|B2|Baseline|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148623|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148605|NCT01369875|B1|Baseline|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148606|NCT01369875|P2|Participant Flow|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148607|NCT01369875|P1|Participant Flow|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148608|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148609|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148610|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148611|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148612|NCT01369875|E2|Reported Event|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148613|NCT01369875|E1|Reported Event|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
148614|NCT01369849|B4|Baseline|Total|Total of all reporting groups
148615|NCT01369849|B3|Baseline|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148616|NCT01369849|B2|Baseline|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148617|NCT01369849|B1|Baseline|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148618|NCT01369849|P3|Participant Flow|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148619|NCT01369849|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148620|NCT01369849|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148621|NCT01369849|O1|Outcome|Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148622|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148673|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
148674|NCT01369745|O5|Outcome|Placebo|placebo once daily
148675|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
148624|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148625|NCT01369849|E3|Reported Event|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148626|NCT01369849|E2|Reported Event|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148627|NCT01369849|E1|Reported Event|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
148628|NCT01369784|B1|Baseline|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148629|NCT01369784|P1|Participant Flow|Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)|patients with refractory/relapsed diffuse large B-cell lymphoma
148630|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148631|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148632|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148633|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148634|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148635|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148636|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148637|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148638|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148639|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148640|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148641|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148642|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148643|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148644|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148645|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148646|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148647|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148648|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148649|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148650|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148651|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148652|NCT01369784|E1|Reported Event|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
148653|NCT01369745|B6|Baseline|Total|Total of all reporting groups
148654|NCT01369745|B5|Baseline|Placebo|placebo once daily
148655|NCT01369745|B4|Baseline|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
148656|NCT01369745|B3|Baseline|Prednisone|Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
148657|NCT01369745|B2|Baseline|Dipyridamole|dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
148658|NCT01369745|B1|Baseline|Prednisolone|Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
148659|NCT01369745|P5|Participant Flow|Placebo|placebo once daily
148660|NCT01369745|P4|Participant Flow|Z102|2.7 mg prednisolone plus 360 mg dipyridamole once daily
148661|NCT01369745|P3|Participant Flow|Prednisone|Prednisone 5 mg once daily
148662|NCT01369745|P2|Participant Flow|Dipyridamole|dipyridamole 360 mg once daily
148663|NCT01369745|P1|Participant Flow|Prednisolone|Prednisolone 2.7 mg once daily
148664|NCT01369745|O5|Outcome|Placebo|placebo once daily
148665|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
148666|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
148667|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
148668|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
148669|NCT01369745|O5|Outcome|Placebo|placebo once daily
148670|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
148671|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
148672|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
148690|NCT01369745|E4|Reported Event|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
148691|NCT01369745|E3|Reported Event|Prednisone|Prednisone 5 mg once daily
148692|NCT01369745|E2|Reported Event|Dipyridamole|dipyridamole 360 mg once daily
148693|NCT01369745|E1|Reported Event|Prednisolone|Prednisolone 2.7 mg daily
148694|NCT01369732|B3|Baseline|Total|Total of all reporting groups
148695|NCT01369732|B2|Baseline|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
148696|NCT01369732|B1|Baseline|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
148697|NCT01369732|P2|Participant Flow|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
148698|NCT01369732|P1|Participant Flow|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
148699|NCT01369732|O2|Outcome|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
148700|NCT01369732|O1|Outcome|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
148701|NCT01369732|E2|Reported Event|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
148702|NCT01369732|E1|Reported Event|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
148703|NCT01369706|B1|Baseline|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
148704|NCT01369706|P1|Participant Flow|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
148705|NCT01369706|O1|Outcome|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
148706|NCT01369706|E1|Reported Event|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
148707|NCT01369680|B5|Baseline|Total|Total of all reporting groups
148708|NCT01369680|B4|Baseline|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
148709|NCT01369680|B3|Baseline|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
148710|NCT01369680|B2|Baseline|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
148711|NCT01369680|B1|Baseline|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
148712|NCT01369680|P4|Participant Flow|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
148713|NCT01369680|P3|Participant Flow|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
148714|NCT01369680|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
148715|NCT01369680|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
148716|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine.
148717|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
148718|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine.
148719|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
148720|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Subjects treated at 1 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
148721|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Subjects treated at 0.5 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
148722|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Subjects treated at 0.25 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
148723|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
148724|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
148725|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
148726|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
148727|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine
148728|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine
148729|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine
148730|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine
148731|NCT01369680|E4|Reported Event|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
148732|NCT01369680|E3|Reported Event|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
148733|NCT01369680|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
148734|NCT01369680|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
148812|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148850|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
148735|NCT01369641|B1|Baseline|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
148736|NCT01369641|P1|Participant Flow|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
148737|NCT01369641|O1|Outcome|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
148738|NCT01369641|E1|Reported Event|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
148739|NCT01369615|B3|Baseline|Total|Total of all reporting groups
148740|NCT01369615|B2|Baseline|≥ 12 to ≤ 16 Years|Children 12 to ≤ 16 years of age
148741|NCT01369615|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
148742|NCT01369615|P2|Participant Flow|≥ 12 to ≤ 16 Years|Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
148743|NCT01369615|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
148744|NCT01369615|O2|Outcome|≥ 12 to ≤ 16 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
148745|NCT01369615|O1|Outcome|6 to < 12 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
148746|NCT01369615|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
148747|NCT01369615|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
148748|NCT01369485|B3|Baseline|Total|Total of all reporting groups
148749|NCT01369485|B2|Baseline|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148750|NCT01369485|B1|Baseline|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148751|NCT01369485|P2|Participant Flow|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
148752|NCT01369485|P1|Participant Flow|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
148753|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148754|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148755|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148756|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148757|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148758|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148759|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148760|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148761|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148762|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148763|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148764|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148765|NCT01369485|O4|Outcome|Open Label Sham Treatement Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148766|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148767|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148768|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148769|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148770|NCT01369485|O3|Outcome|Open Label Active Treatment Group.|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148771|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148772|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148773|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148774|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148775|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148776|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148777|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148778|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148779|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148780|NCT01369485|O3|Outcome|Open Label Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148781|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148849|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52).
162024|NCT01317667|B2|Baseline|Group 2|RVEc vaccine 50 μg/dose x 3 doses
148782|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148783|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148784|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
148785|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148786|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148787|NCT01369485|E4|Reported Event|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
148788|NCT01369485|E3|Reported Event|Open Label Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
148789|NCT01369485|E2|Reported Event|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148790|NCT01369485|E1|Reported Event|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
148791|NCT01369342|B4|Baseline|Total|Total of all reporting groups
148792|NCT01369342|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148793|NCT01369342|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148794|NCT01369342|B1|Baseline|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148795|NCT01369342|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148796|NCT01369342|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148797|NCT01369342|P1|Participant Flow|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148798|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148799|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148800|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148801|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148802|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148803|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148804|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148805|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148806|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148807|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148808|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148809|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148810|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148811|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148813|NCT01369342|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148814|NCT01369342|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
148815|NCT01369342|E1|Reported Event|Placebo IV|Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
148816|NCT01369329|B4|Baseline|Total|Total of all reporting groups
148817|NCT01369329|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148818|NCT01369329|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148819|NCT01369329|B1|Baseline|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148820|NCT01369329|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148821|NCT01369329|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148822|NCT01369329|P1|Participant Flow|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148823|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148824|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148825|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148826|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148827|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148828|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148829|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148830|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148831|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148832|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148833|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148834|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148835|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148836|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148837|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
148838|NCT01369329|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
148839|NCT01369329|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
148840|NCT01369329|E1|Reported Event|Placebo|Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
148841|NCT01369030|B1|Baseline|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148842|NCT01369030|P1|Participant Flow|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148843|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148844|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148845|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148846|NCT01369030|E1|Reported Event|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
148847|NCT01368965|B1|Baseline|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
148848|NCT01368965|P1|Participant Flow|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
148851|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
148852|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
148853|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
148854|NCT01368965|O1|Outcome|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
148855|NCT01368965|E1|Reported Event|Enrolled Subjects|Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment.
148856|NCT01368900|B1|Baseline|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
148857|NCT01368900|P1|Participant Flow|Treated Subjects|"The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.~Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.~All study subjects received an Ulthera treatment to the upper face."
148858|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
148859|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
148860|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
148861|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
148862|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
148863|NCT01368900|O1|Outcome|Subjects Treated|All study subject received an Ulthera treatment to the upper face.
148864|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
148865|NCT01368900|E1|Reported Event|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
148866|NCT01368874|B4|Baseline|Total|Total of all reporting groups
148867|NCT01368874|B3|Baseline|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148868|NCT01368874|B2|Baseline|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148869|NCT01368874|B1|Baseline|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148870|NCT01368874|P3|Participant Flow|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148871|NCT01368874|P2|Participant Flow|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148872|NCT01368874|P1|Participant Flow|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148873|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
148874|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148875|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148876|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
148877|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 180 day post-treatment visit.
148878|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
148879|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148880|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148881|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148882|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 90 day post-treatment visit.
148883|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
148884|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148885|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148886|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148887|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 60 day post-treatment visit.
148888|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
148889|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
148890|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
148891|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
148892|NCT01368874|O1|Outcome|All Subjects Treated|Sixty (60) of 64 treated participants completed the 180-day study visit.
149018|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their anxiety score.
148893|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
148894|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
148895|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
148896|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
148897|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
148898|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
148899|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
148900|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
148901|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
148902|NCT01368874|O1|Outcome|All Subjects Treated|Sixty(60) of 64 treated participants completed the 180-day study visit.
148903|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148904|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148905|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148906|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
148907|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular, and lower neck regions.
148908|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
148909|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
148910|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
148911|NCT01368874|O1|Outcome|All Subjects Treated|A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
148912|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
148913|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
148914|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
148915|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
148916|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
148917|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Thirty (30) participants completed the 60-day study visit.
148918|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
148919|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
148920|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
148921|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 60- visit.
148922|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
148923|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up
148924|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
149019|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention and represents their anxiety score.
148925|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.
148926|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.
148927|NCT01368874|E4|Reported Event|Groups B/C|
148928|NCT01368874|E3|Reported Event|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
148929|NCT01368874|E2|Reported Event|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
148930|NCT01368874|E1|Reported Event|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
148931|NCT01368835|B1|Baseline|Ulthera Treatment|Treatment to the lower face and submental region.
148932|NCT01368835|P1|Participant Flow|Ulthera Treatment|Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
148933|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
148934|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
148935|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
148936|NCT01368835|O1|Outcome|Ulthera Treatment|Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
148937|NCT01368835|E1|Reported Event|Ulthera Treatment|Treatment to the lower face and submental region.
148938|NCT01368809|B3|Baseline|Total|Total of all reporting groups
148939|NCT01368809|B2|Baseline|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
148940|NCT01368809|B1|Baseline|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
148941|NCT01368809|P2|Participant Flow|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
148942|NCT01368809|P1|Participant Flow|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
148943|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
148944|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
148945|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
148946|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
148947|NCT01368809|O2|Outcome|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
148948|NCT01368809|O1|Outcome|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
148949|NCT01368809|E2|Reported Event|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
148950|NCT01368809|E1|Reported Event|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
148951|NCT01368653|B3|Baseline|Total|Total of all reporting groups
148952|NCT01368653|B2|Baseline|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148953|NCT01368653|B1|Baseline|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148954|NCT01368653|P2|Participant Flow|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148955|NCT01368653|P1|Participant Flow|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148956|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
148984|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
150072|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
148957|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
148958|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148959|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148960|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
148961|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
148962|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148963|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148964|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148965|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148966|NCT01368653|E4|Reported Event|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
148967|NCT01368653|E3|Reported Event|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
148985|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
150244|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
148968|NCT01368653|E2|Reported Event|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
148969|NCT01368653|E1|Reported Event|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
148970|NCT01368536|B4|Baseline|Total|Total of all reporting groups
148971|NCT01368536|B3|Baseline|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148972|NCT01368536|B2|Baseline|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148973|NCT01368536|B1|Baseline|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148974|NCT01368536|P3|Participant Flow|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148975|NCT01368536|P2|Participant Flow|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148976|NCT01368536|P1|Participant Flow|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148977|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148978|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148979|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148980|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148981|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148982|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148983|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
149016|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
149017|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention and represents their anxiety score.
148986|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148987|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148988|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148989|NCT01368536|O2|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148990|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148991|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148992|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148993|NCT01368536|E3|Reported Event|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
148994|NCT01368536|E2|Reported Event|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
148995|NCT01368536|E1|Reported Event|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
148996|NCT01368432|B3|Baseline|Total|Total of all reporting groups
148997|NCT01368432|B2|Baseline|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
148998|NCT01368432|B1|Baseline|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
148999|NCT01368432|P2|Participant Flow|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
149000|NCT01368432|P1|Participant Flow|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
149001|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
149002|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
149003|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
149004|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
149005|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
149006|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
149007|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
149008|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
149009|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
149010|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
149011|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
149012|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
149013|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
149014|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
149015|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
149020|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their anxiety score.
149021|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram and represents their global health at 12 weeks.
149022|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
149023|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram and represents their baseline global health
149024|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their baseline global health.
149025|NCT01368432|O2|Outcome|Treatment Group MADRS 12 Weeks|This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
149026|NCT01368432|O1|Outcome|Placebo Group MADRS 12 Weeks|This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
149027|NCT01368432|O2|Outcome|Treatment Group Baseline|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
149028|NCT01368432|O1|Outcome|Placebo Group Baseline|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
149029|NCT01368432|E2|Reported Event|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
149030|NCT01368432|E1|Reported Event|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
149031|NCT01368406|B3|Baseline|Total|Total of all reporting groups
149032|NCT01368406|B2|Baseline|Treatment as Usual|treatment as usual received by the patients
149033|NCT01368406|B1|Baseline|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
149034|NCT01368406|P2|Participant Flow|Treatment as Usual|treatment as usual received by the patients
149035|NCT01368406|P1|Participant Flow|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
149036|NCT01368406|O2|Outcome|Treatment as Usual|treatment as usual received by the patients
149037|NCT01368406|O1|Outcome|Wellness Program|lifestyle intervention for 12 weeks
149038|NCT01368406|E2|Reported Event|Treatment as Usual|treatment as usual received by the patients
149039|NCT01368406|E1|Reported Event|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
149040|NCT01368276|B3|Baseline|Total|Total of all reporting groups
149041|NCT01368276|B2|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149042|NCT01368276|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149043|NCT01368276|P2|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149044|NCT01368276|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149045|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149046|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149063|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149047|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149048|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149049|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149050|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149051|NCT01368276|E2|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149052|NCT01368276|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
149053|NCT01368263|B4|Baseline|Total|Total of all reporting groups
149054|NCT01368263|B3|Baseline|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149055|NCT01368263|B2|Baseline|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149056|NCT01368263|B1|Baseline|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149057|NCT01368263|P3|Participant Flow|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149058|NCT01368263|P2|Participant Flow|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149059|NCT01368263|P1|Participant Flow|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149060|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149061|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149062|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149064|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149065|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149066|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149067|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149068|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149069|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149070|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149071|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149072|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149073|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149074|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149075|NCT01368263|E3|Reported Event|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149076|NCT01368263|E2|Reported Event|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
149077|NCT01368263|E1|Reported Event|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
149078|NCT01368211|B3|Baseline|Total|Total of all reporting groups
149079|NCT01368211|B2|Baseline|Reference First, Then Mirasol|"This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
149080|NCT01368211|B1|Baseline|Mirasol First, Then Reference|"This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
150073|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
149081|NCT01368211|P2|Participant Flow|Reference First, Then Mirasol|"This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
149082|NCT01368211|P1|Participant Flow|Mirasol First, Then Reference|"This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
149083|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
149084|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
149085|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
149086|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
149087|NCT01368211|E2|Reported Event|Untreated Reference Platelets|Patients that received an untreated reference2-4-day-old platelet transfusion.
149088|NCT01368211|E1|Reported Event|Mirasol-treated Platelets|Patients that received a Mirasol treated 2-4-day-old platelet transfusion.
149089|NCT01368185|B1|Baseline|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149090|NCT01368185|P1|Participant Flow|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149091|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149092|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149093|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149094|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149095|NCT01368185|E1|Reported Event|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
149096|NCT01368081|B14|Baseline|Total|Total of all reporting groups
149097|NCT01368081|B13|Baseline|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149098|NCT01368081|B12|Baseline|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149099|NCT01368081|B11|Baseline|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149100|NCT01368081|B10|Baseline|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149101|NCT01368081|B9|Baseline|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149102|NCT01368081|B8|Baseline|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149103|NCT01368081|B7|Baseline|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149104|NCT01368081|B6|Baseline|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149105|NCT01368081|B5|Baseline|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149106|NCT01368081|B4|Baseline|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149107|NCT01368081|B3|Baseline|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149108|NCT01368081|B2|Baseline|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149109|NCT01368081|B1|Baseline|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149110|NCT01368081|P13|Participant Flow|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149111|NCT01368081|P12|Participant Flow|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149112|NCT01368081|P11|Participant Flow|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
149113|NCT01368081|P10|Participant Flow|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
149114|NCT01368081|P9|Participant Flow|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149115|NCT01368081|P8|Participant Flow|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149116|NCT01368081|P7|Participant Flow|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149117|NCT01368081|P6|Participant Flow|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149118|NCT01368081|P5|Participant Flow|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149119|NCT01368081|P4|Participant Flow|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149120|NCT01368081|P3|Participant Flow|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149121|NCT01368081|P2|Participant Flow|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149122|NCT01368081|P1|Participant Flow|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149123|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149124|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149125|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149126|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149127|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149128|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149129|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149130|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149131|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149132|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149133|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149134|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149135|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149136|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149137|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149138|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149139|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149140|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149141|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149142|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149143|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149144|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149145|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149146|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149147|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149148|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149149|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149150|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149151|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
150245|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
149152|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
149153|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149154|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
149155|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149156|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149157|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149158|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149159|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149160|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149161|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149162|NCT01368081|E13|Reported Event|Glinide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149163|NCT01368081|E12|Reported Event|Glinide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
149164|NCT01368081|E11|Reported Event|DPP-4 Inhibitor: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
149165|NCT01368081|E10|Reported Event|DPP-4 Inhibitor: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
149166|NCT01368081|E9|Reported Event|Alpha-GI: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
149167|NCT01368081|E8|Reported Event|Alpha-GI: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
149168|NCT01368081|E7|Reported Event|Thiazolidinedione: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149169|NCT01368081|E6|Reported Event|Thiazolidinedione: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
149170|NCT01368081|E5|Reported Event|Biguanide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149171|NCT01368081|E4|Reported Event|Biguanide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
149172|NCT01368081|E3|Reported Event|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
149173|NCT01368081|E2|Reported Event|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149174|NCT01368081|E1|Reported Event|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
149175|NCT01368042|B1|Baseline|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149176|NCT01368042|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149177|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149178|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149179|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149180|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149181|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149182|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149183|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149184|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149185|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149186|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149187|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149188|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149189|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149190|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149191|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149192|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149193|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149194|NCT01368042|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
149195|NCT01367886|B1|Baseline|Fesoterodine|Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
149196|NCT01367886|P1|Participant Flow|Fesoterodine|"Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149197|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149198|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149199|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149200|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149201|NCT01367886|E1|Reported Event|Fesoterodine|"Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
149202|NCT01367860|B3|Baseline|Total|Total of all reporting groups
149203|NCT01367860|B2|Baseline|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149204|NCT01367860|B1|Baseline|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149205|NCT01367860|P2|Participant Flow|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149206|NCT01367860|P1|Participant Flow|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149207|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149208|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149209|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149466|NCT01367119|B1|Baseline|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
149210|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149211|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149212|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149213|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149214|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149215|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149216|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149217|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149218|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149219|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149220|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149221|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149222|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149223|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149224|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149225|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149226|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149227|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149228|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149229|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149230|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149231|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149232|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149233|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149234|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149235|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149236|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149237|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149238|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149239|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149240|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149241|NCT01367860|E2|Reported Event|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
149242|NCT01367860|E1|Reported Event|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
149243|NCT01367704|B3|Baseline|Total|Total of all reporting groups
149244|NCT01367704|B2|Baseline|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149245|NCT01367704|B1|Baseline|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
149246|NCT01367704|P2|Participant Flow|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149247|NCT01367704|P1|Participant Flow|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
149248|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149249|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
150246|NCT01363700|E5|Reported Event|Placebo Ophthalmic Solution Period2|Count unit was defined each eye.
149250|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149251|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149252|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149253|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149254|NCT01367704|E2|Reported Event|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
149255|NCT01367704|E1|Reported Event|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
149256|NCT01367665|B3|Baseline|Total|Total of all reporting groups
149257|NCT01367665|B2|Baseline|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149258|NCT01367665|B1|Baseline|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149259|NCT01367665|P2|Participant Flow|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149260|NCT01367665|P1|Participant Flow|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149261|NCT01367665|O2|Outcome|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149262|NCT01367665|O1|Outcome|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149263|NCT01367665|E2|Reported Event|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149264|NCT01367665|E1|Reported Event|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
149265|NCT01367457|B4|Baseline|Total|Total of all reporting groups
149467|NCT01367119|P2|Participant Flow|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149266|NCT01367457|B3|Baseline|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149267|NCT01367457|B2|Baseline|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149268|NCT01367457|B1|Baseline|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149269|NCT01367457|P3|Participant Flow|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149270|NCT01367457|P2|Participant Flow|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149271|NCT01367457|P1|Participant Flow|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149272|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149273|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149274|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149275|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149276|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149277|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149278|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149279|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149280|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149281|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149282|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149283|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149284|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149285|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149286|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149287|NCT01367457|E3|Reported Event|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
149288|NCT01367457|E2|Reported Event|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
149289|NCT01367457|E1|Reported Event|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
149290|NCT01367249|B3|Baseline|Total|Total of all reporting groups
149291|NCT01367249|B2|Baseline|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
149292|NCT01367249|B1|Baseline|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
149293|NCT01367249|P2|Participant Flow|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
149294|NCT01367249|P1|Participant Flow|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
149295|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
149296|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
149297|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
149298|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
149299|NCT01367249|E2|Reported Event|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
149300|NCT01367249|E1|Reported Event|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
149301|NCT01367158|B12|Baseline|Total|Total of all reporting groups
149302|NCT01367158|B11|Baseline|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
149303|NCT01367158|B10|Baseline|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
149304|NCT01367158|B9|Baseline|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
149305|NCT01367158|B8|Baseline|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
149306|NCT01367158|B7|Baseline|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
149307|NCT01367158|B6|Baseline|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
149308|NCT01367158|B5|Baseline|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
149309|NCT01367158|B4|Baseline|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
149310|NCT01367158|B3|Baseline|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
149311|NCT01367158|B2|Baseline|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
149312|NCT01367158|B1|Baseline|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
149313|NCT01367158|P11|Participant Flow|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
149314|NCT01367158|P10|Participant Flow|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
149315|NCT01367158|P9|Participant Flow|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
149316|NCT01367158|P8|Participant Flow|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
149317|NCT01367158|P7|Participant Flow|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
149318|NCT01367158|P6|Participant Flow|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
149319|NCT01367158|P5|Participant Flow|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
149320|NCT01367158|P4|Participant Flow|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
149321|NCT01367158|P3|Participant Flow|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
149322|NCT01367158|P2|Participant Flow|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
149323|NCT01367158|P1|Participant Flow|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
149324|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149325|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149326|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149327|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149328|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
150247|NCT01363700|E4|Reported Event|Olopatadine Ophthalmic Solution Period2|Count unit was defined each eye.
149329|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149330|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149331|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149332|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149333|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149334|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149335|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149336|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149337|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149338|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149339|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149340|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149341|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149342|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149343|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149344|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149345|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149346|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149347|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149348|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149349|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149350|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149351|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149352|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149353|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149354|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149468|NCT01367119|P1|Participant Flow|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
162025|NCT01317667|B1|Baseline|Group 1|RVEc vaccine 20 μg/dose x 3 doses
149355|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149356|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149357|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149358|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149359|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149360|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149361|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149362|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149363|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149364|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149365|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149366|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149367|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149368|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149369|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149370|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149371|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149372|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149373|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149374|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149375|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149376|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149377|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149378|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149379|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149380|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149381|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149382|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149383|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149384|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149385|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149386|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149387|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149388|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149389|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
149390|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149391|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149392|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149393|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149394|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149395|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149396|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149397|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149398|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149399|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149400|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149401|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149402|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149403|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149404|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149405|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149406|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149407|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149408|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149409|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
162478|NCT01316042|O2|Outcome|Metformin|2 212.5mg pill/day for 12 months
149410|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149411|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149412|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149413|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149414|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149415|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149416|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149417|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149418|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149419|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149420|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149421|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149422|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149423|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149424|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149425|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149426|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149427|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149428|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149429|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149430|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149431|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149432|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149433|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149434|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149435|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149436|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149437|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149438|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149439|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149440|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149441|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149442|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149443|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149444|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149445|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149446|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149447|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149448|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149449|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149450|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149451|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149452|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149453|NCT01367158|E11|Reported Event|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
149454|NCT01367158|E10|Reported Event|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
149455|NCT01367158|E9|Reported Event|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
149456|NCT01367158|E8|Reported Event|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
149457|NCT01367158|E7|Reported Event|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
149458|NCT01367158|E6|Reported Event|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
149459|NCT01367158|E5|Reported Event|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
149460|NCT01367158|E4|Reported Event|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149461|NCT01367158|E3|Reported Event|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149462|NCT01367158|E2|Reported Event|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
149463|NCT01367158|E1|Reported Event|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
149464|NCT01367119|B3|Baseline|Total|Total of all reporting groups
149465|NCT01367119|B2|Baseline|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149469|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149470|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
149471|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149472|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
149473|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149474|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
149475|NCT01367119|E2|Reported Event|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
149476|NCT01367119|E1|Reported Event|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
149477|NCT01367080|B3|Baseline|Total|Total of all reporting groups
149478|NCT01367080|B2|Baseline|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
149479|NCT01367080|B1|Baseline|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
149480|NCT01367080|P2|Participant Flow|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
149481|NCT01367080|P1|Participant Flow|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
149482|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
149483|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
149484|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
149485|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
149486|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
149487|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
149488|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline hydrochloride 25mg administration Group
149489|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg administration Group
149490|NCT01367080|E2|Reported Event|Etravil 25mg Group|Amitryptyline hydrochloride 25mg administration Group
149491|NCT01367080|E1|Reported Event|Etravil 10mg Group|Amitryptyline hydrochloride 10mg administration Group
149492|NCT01366976|B3|Baseline|Total|Total of all reporting groups
149493|NCT01366976|B2|Baseline|Placebo|Saline in equivalent volume as study drug
149494|NCT01366976|B1|Baseline|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149495|NCT01366976|P2|Participant Flow|Placebo|Saline in equivalent volume as study drug
149496|NCT01366976|P1|Participant Flow|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149497|NCT01366976|O2|Outcome|Placebo|Saline infusion
149498|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149499|NCT01366976|O2|Outcome|Placebo|Saline infusion
149500|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149501|NCT01366976|O2|Outcome|Placebo|Saline infusion
149502|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149503|NCT01366976|O2|Outcome|Placebo|Saline infusion
149504|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149505|NCT01366976|E2|Reported Event|Placebo|Saline infusion
149506|NCT01366976|E1|Reported Event|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
149507|NCT01366885|B1|Baseline|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
149508|NCT01366885|P1|Participant Flow|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
149509|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
149510|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
162479|NCT01316042|O1|Outcome|Sugar Pill|2 pills per day for 12 months
149511|NCT01366885|E1|Reported Event|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
149512|NCT01366872|B1|Baseline|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149513|NCT01366872|P1|Participant Flow|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149514|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149515|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149516|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149517|NCT01366872|E1|Reported Event|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
149518|NCT01366846|B5|Baseline|Total|Total of all reporting groups
149519|NCT01366846|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149520|NCT01366846|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149521|NCT01366846|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149522|NCT01366846|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149523|NCT01366846|P2|Participant Flow|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
149524|NCT01366846|P1|Participant Flow|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
149525|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
149526|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
149527|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
149528|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
149529|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149567|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149530|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149531|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149532|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149533|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
149534|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
149535|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149536|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149537|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149538|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149539|NCT01366846|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149540|NCT01366846|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149541|NCT01366846|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
149542|NCT01366846|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
149543|NCT01366638|B4|Baseline|Total|Total of all reporting groups
149544|NCT01366638|B3|Baseline|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149545|NCT01366638|B2|Baseline|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149546|NCT01366638|B1|Baseline|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149547|NCT01366638|P3|Participant Flow|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149548|NCT01366638|P2|Participant Flow|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149549|NCT01366638|P1|Participant Flow|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149550|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149551|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149552|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149553|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149554|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149555|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149556|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149557|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149558|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149559|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149560|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149561|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149562|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149563|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149564|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149565|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149566|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149568|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149569|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149570|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149571|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149572|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149573|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149574|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149575|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149576|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149577|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149578|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149579|NCT01366638|E3|Reported Event|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
149580|NCT01366638|E2|Reported Event|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149581|NCT01366638|E1|Reported Event|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
149582|NCT01366521|B5|Baseline|Total|Total of all reporting groups
149583|NCT01366521|B4|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149584|NCT01366521|B3|Baseline|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149585|NCT01366521|B2|Baseline|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149586|NCT01366521|B1|Baseline|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149683|NCT01366209|E2|Reported Event|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
150248|NCT01363700|E3|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period2|Count unit was defined each eye.
149587|NCT01366521|P4|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149588|NCT01366521|P3|Participant Flow|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149589|NCT01366521|P2|Participant Flow|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149590|NCT01366521|P1|Participant Flow|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149591|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149592|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149593|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149594|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149595|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149596|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149597|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149598|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149599|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149600|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149601|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149602|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149603|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149604|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149605|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149606|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149607|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149608|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
150249|NCT01363700|E2|Reported Event|Placebo Ophthalmic Solution Period1|Count unit was defined each eye.
149609|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149610|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149611|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149612|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149613|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149614|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149615|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149616|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149617|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149618|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149619|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149620|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149621|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149622|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149623|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149624|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149625|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149626|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149627|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149628|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149629|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149630|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149684|NCT01366209|E1|Reported Event|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
149631|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149632|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149633|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149634|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149635|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149636|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149637|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149638|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149639|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149640|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149641|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149642|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149643|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149644|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149645|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149646|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149647|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149648|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149649|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149650|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149651|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149652|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149685|NCT01366092|B1|Baseline|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
168477|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
149653|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149654|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149655|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149656|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149657|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149658|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149659|NCT01366521|E5|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149660|NCT01366521|E4|Reported Event|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149661|NCT01366521|E3|Reported Event|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149662|NCT01366521|E2|Reported Event|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149663|NCT01366521|E1|Reported Event|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
149664|NCT01366443|B1|Baseline|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
149665|NCT01366443|P1|Participant Flow|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
149666|NCT01366443|O2|Outcome|Pregnant Women (ROM Plus vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
149667|NCT01366443|O1|Outcome|Pregnant Women (Clinical Assessment vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
149668|NCT01366443|E1|Reported Event|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
149669|NCT01366417|B1|Baseline|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
149670|NCT01366417|P1|Participant Flow|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
149671|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
149672|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
149673|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
149674|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
149675|NCT01366417|E1|Reported Event|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
149676|NCT01366209|B3|Baseline|Total|Total of all reporting groups
149677|NCT01366209|B2|Baseline|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
149678|NCT01366209|B1|Baseline|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
149679|NCT01366209|P2|Participant Flow|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
149680|NCT01366209|P1|Participant Flow|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
149681|NCT01366209|O2|Outcome|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
149682|NCT01366209|O1|Outcome|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
149686|NCT01366092|P1|Participant Flow|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149687|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149688|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149689|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149690|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149691|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149692|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149693|NCT01366092|E1|Reported Event|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
149694|NCT01365910|B1|Baseline|Treatment (Enzyme Inhibitor)|Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
149695|NCT01365910|P1|Participant Flow|Treatment (Enzyme Inhibitor)|ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.
149696|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
149697|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
149698|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
149699|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
149700|NCT01365910|E1|Reported Event|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
149701|NCT01365845|B1|Baseline|Breast Patients Planned With Both Proton & Conventional Plans|"Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
149702|NCT01365845|P3|Participant Flow|3D-Proton/Conventional Plan or 3D-proton Only|"3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
149703|NCT01365845|P2|Participant Flow|Conventional Photon Plan|"Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
149704|NCT01365845|P1|Participant Flow|Induction Phase|During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
149705|NCT01365845|O2|Outcome|3D-Proton/Conventional Plan or 3D-proton Only|3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
149706|NCT01365845|O1|Outcome|Conventional Photon Plan|Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
149707|NCT01365845|E1|Reported Event|Breast Patients Planned With Both Proton & Conventional Plans|"All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.~Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
149708|NCT01364558|B1|Baseline|Diazepam Nasal Spray Suspension/Spray/Injection|
149709|NCT01364558|P3|Participant Flow|Diazepam Injection|Diazepam injection
149710|NCT01364558|P2|Participant Flow|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
149711|NCT01364558|P1|Participant Flow|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
149712|NCT01364558|O3|Outcome|Diazepam Injection|Diazepam injection
149713|NCT01364558|O2|Outcome|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
149714|NCT01364558|O1|Outcome|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
149715|NCT01364558|E3|Reported Event|Diazepam Injection|
149716|NCT01364558|E2|Reported Event|Diazepam Nasal Spray Solution|
149717|NCT01364558|E1|Reported Event|Diazepam Nasal Spray Suspension|
149718|NCT01365650|B1|Baseline|All Study Participants|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
149746|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149719|NCT01365650|P1|Participant Flow|Symptomatic Allergic Rhinitis|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
149720|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149721|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149722|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149723|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149724|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149725|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149726|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149727|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149728|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149729|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149730|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149731|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149732|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149733|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149734|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149735|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149736|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149737|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149738|NCT01365650|E3|Reported Event|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
149739|NCT01365650|E2|Reported Event|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
149740|NCT01365650|E1|Reported Event|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
149741|NCT01365624|B3|Baseline|Total|Total of all reporting groups
149742|NCT01365624|B2|Baseline|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149743|NCT01365624|B1|Baseline|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149744|NCT01365624|P2|Participant Flow|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149745|NCT01365624|P1|Participant Flow|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149870|NCT01365455|B4|Baseline|Total|Total of all reporting groups
168547|NCT01294306|B3|Baseline|Total|Total of all reporting groups
149747|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149748|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149749|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149750|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149751|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149752|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149753|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149754|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149755|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149756|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149757|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149758|NCT01365624|E2|Reported Event|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149759|NCT01365624|E1|Reported Event|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
149760|NCT01365611|B1|Baseline|All Study Participants|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149761|NCT01365611|P1|Participant Flow|All Study Participants|"A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.~Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6."
149762|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149763|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149764|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149765|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149766|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149767|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149768|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149769|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149770|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149771|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149772|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149773|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149774|NCT01365611|E2|Reported Event|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
149775|NCT01365611|E1|Reported Event|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
149776|NCT01365585|B1|Baseline|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
150250|NCT01363700|E1|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period1|Count unit was defined each eye.
149777|NCT01365585|P1|Participant Flow|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149778|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149779|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149780|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149781|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149782|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149783|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149784|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149785|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149786|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149787|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149788|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149789|NCT01365585|E1|Reported Event|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
149790|NCT01365546|B1|Baseline|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
149791|NCT01365546|P1|Participant Flow|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
149792|NCT01365546|O1|Outcome|Post-operative Assessment by IDMC|
149793|NCT01365546|O1|Outcome|Intra-operative Assessment by IDMC|
149794|NCT01365546|O3|Outcome|All Surgeries|
149795|NCT01365546|O2|Outcome|Major Surgery|
149796|NCT01365546|O1|Outcome|Minor Surgery|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
149797|NCT01365546|E1|Reported Event|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
149798|NCT01365507|B3|Baseline|Total|Total of all reporting groups
149799|NCT01365507|B2|Baseline|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149800|NCT01365507|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149801|NCT01365507|P2|Participant Flow|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149802|NCT01365507|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149803|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149804|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149805|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149806|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149807|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149808|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149809|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149810|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149811|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149812|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149813|NCT01365507|E2|Reported Event|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
149814|NCT01365507|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
149815|NCT01365494|B3|Baseline|Total|Total of all reporting groups
149816|NCT01365494|B2|Baseline|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules."
149817|NCT01365494|B1|Baseline|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules."
149818|NCT01365494|P2|Participant Flow|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149819|NCT01365494|P1|Participant Flow|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule."
149820|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149821|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
149822|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149823|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
150251|NCT01363661|B3|Baseline|Total|Total of all reporting groups
149824|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149825|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
149826|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149827|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
149828|NCT01365494|E2|Reported Event|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
149829|NCT01365494|E1|Reported Event|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
149830|NCT01365481|B5|Baseline|Total|Total of all reporting groups
149831|NCT01365481|B4|Baseline|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149832|NCT01365481|B3|Baseline|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149833|NCT01365481|B2|Baseline|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149834|NCT01365481|B1|Baseline|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149835|NCT01365481|P4|Participant Flow|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149836|NCT01365481|P3|Participant Flow|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149837|NCT01365481|P2|Participant Flow|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149838|NCT01365481|P1|Participant Flow|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149839|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149928|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
150074|NCT01364740|E1|Reported Event|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
149840|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149841|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149842|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149843|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149844|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149845|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149846|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149847|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149848|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149849|NCT01365481|E6|Reported Event|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149850|NCT01365481|E5|Reported Event|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149851|NCT01365481|E4|Reported Event|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149852|NCT01365481|E3|Reported Event|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149853|NCT01365481|E2|Reported Event|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
149854|NCT01365481|E1|Reported Event|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
149855|NCT01365468|B3|Baseline|Total|Total of all reporting groups
149856|NCT01365468|B2|Baseline|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149857|NCT01365468|B1|Baseline|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149858|NCT01365468|P2|Participant Flow|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149859|NCT01365468|P1|Participant Flow|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149860|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149861|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149862|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149863|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149864|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149865|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149866|NCT01365468|O1|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149867|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149868|NCT01365468|E2|Reported Event|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149869|NCT01365468|E1|Reported Event|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
149871|NCT01365455|B3|Baseline|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149872|NCT01365455|B2|Baseline|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149873|NCT01365455|B1|Baseline|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149874|NCT01365455|P5|Participant Flow|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149875|NCT01365455|P4|Participant Flow|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149876|NCT01365455|P3|Participant Flow|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149877|NCT01365455|P2|Participant Flow|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149878|NCT01365455|P1|Participant Flow|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149879|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149880|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149881|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149882|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149883|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149884|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149885|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149886|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149887|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149888|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149889|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
150075|NCT01364649|B3|Baseline|Total|Total of all reporting groups
149890|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149891|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149892|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149893|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149894|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149895|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149896|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149897|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149898|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149899|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149900|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149901|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149902|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149903|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149904|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149905|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149906|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149907|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149908|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
150252|NCT01363661|B2|Baseline|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
149909|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149910|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149911|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149912|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149913|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149914|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149915|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149916|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149917|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149918|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149919|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149920|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149921|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149922|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149923|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149924|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149925|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149926|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149927|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
150820|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
149929|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149930|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149931|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149932|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149933|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149934|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149935|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149936|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149937|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149938|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149939|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149940|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149941|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149942|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149943|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149944|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149945|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149946|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
150026|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
169012|NCT01291784|O2|Outcome|Sub B|Subject B
149947|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149948|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149949|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149950|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149951|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
149952|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149953|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
149954|NCT01365455|E11|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
149955|NCT01365455|E10|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
149956|NCT01365455|E9|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
149957|NCT01365455|E8|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
149958|NCT01365455|E7|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
149959|NCT01365455|E6|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
149960|NCT01365455|E5|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
149961|NCT01365455|E4|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
149962|NCT01365455|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
149963|NCT01365455|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
149964|NCT01365455|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
149965|NCT01365273|B3|Baseline|Total|Total of all reporting groups
149966|NCT01365273|B2|Baseline|Mepitel One|Device
149967|NCT01365273|B1|Baseline|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149968|NCT01365273|P2|Participant Flow|Mepitel One|Device
149969|NCT01365273|P1|Participant Flow|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149970|NCT01365273|O2|Outcome|Mepitel One|Device
149971|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149972|NCT01365273|O2|Outcome|Mepitel One|Device
149973|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149974|NCT01365273|O2|Outcome|Mepitel One|Device
149975|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149976|NCT01365273|E2|Reported Event|Mepitel One|Device
149977|NCT01365273|E1|Reported Event|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
149978|NCT01365130|B1|Baseline|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
149979|NCT01365130|P1|Participant Flow|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
149980|NCT01365130|O1|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
149981|NCT01365130|E1|Reported Event|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
149982|NCT01365091|B5|Baseline|Total|Total of all reporting groups
149983|NCT01365091|B4|Baseline|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
150027|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150028|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150821|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
149984|NCT01365091|B3|Baseline|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
149985|NCT01365091|B2|Baseline|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
149986|NCT01365091|B1|Baseline|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
149987|NCT01365091|P4|Participant Flow|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
149988|NCT01365091|P3|Participant Flow|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
149989|NCT01365091|P2|Participant Flow|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
149990|NCT01365091|P1|Participant Flow|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
149991|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
149992|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
150029|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150030|NCT01365052|E2|Reported Event|Placebo|2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
149993|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
149994|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
149995|NCT01365091|O4|Outcome|Arm 4: Treatments G,H/H,G|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
149996|NCT01365091|O3|Outcome|Arm 3: Treatments E,F/ F,E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
149997|NCT01365091|O2|Outcome|Arm 2: Treatments C,D/D,C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
149998|NCT01365091|O1|Outcome|Arm 1: Treatments A,B/B,A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
149999|NCT01365091|O4|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
150000|NCT01365091|O3|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
150001|NCT01365091|O2|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
150031|NCT01365052|E1|Reported Event|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150032|NCT01365039|B3|Baseline|Total|Total of all reporting groups
150002|NCT01365091|O1|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
150003|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
150004|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
150005|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
150006|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
150007|NCT01365091|E8|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed|FDC=fixed-dose combination
150008|NCT01365091|E7|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting|FDC=fixed-dose combination
150009|NCT01365091|E6|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed|FDC=fixed-dose combination
150010|NCT01365091|E5|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting|FDC=fixed-dose combination
150011|NCT01365091|E4|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fed|XR=extended release
150012|NCT01365091|E3|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting|XR=extended release
150013|NCT01365091|E2|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed|XR=extended release
150014|NCT01365091|E1|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting|XR=extended release
150015|NCT01365052|B3|Baseline|Total|Total of all reporting groups
150016|NCT01365052|B2|Baseline|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150017|NCT01365052|B1|Baseline|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150018|NCT01365052|P2|Participant Flow|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150019|NCT01365052|P1|Participant Flow|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150020|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150021|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150022|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150023|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150024|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
150025|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
150033|NCT01365039|B2|Baseline|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150034|NCT01365039|B1|Baseline|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150035|NCT01365039|P2|Participant Flow|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150036|NCT01365039|P1|Participant Flow|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150037|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150038|NCT01365039|O1|Outcome|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150039|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150040|NCT01365039|O1|Outcome|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150041|NCT01365039|E2|Reported Event|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150042|NCT01365039|E1|Reported Event|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
150043|NCT01364922|B4|Baseline|Total|Total of all reporting groups
150044|NCT01364922|B3|Baseline|DB Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
150045|NCT01364922|B2|Baseline|DB Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
150046|NCT01364922|B1|Baseline|OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
150047|NCT01364922|P3|Participant Flow|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
150048|NCT01364922|P2|Participant Flow|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
150049|NCT01364922|P1|Participant Flow|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
150050|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
150051|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
150052|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
150053|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
150054|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
150055|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
150056|NCT01364922|E3|Reported Event|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
150057|NCT01364922|E2|Reported Event|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
150071|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
169013|NCT01291784|O1|Outcome|Sub A|Subject A
150058|NCT01364922|E1|Reported Event|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
150059|NCT01364896|B1|Baseline|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150060|NCT01364896|P1|Participant Flow|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150061|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150062|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150063|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150064|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150065|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
150066|NCT01364896|E1|Reported Event|Inflammatory Bowel Disease, Immunosuppressive Agent|Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
150067|NCT01364740|B1|Baseline|PMP-300E, In-Lab PSG|"PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)~PMP-300E: Data collected from Level 3 device~In-lab PSG: Data collected from Type I In-Lab Polysomnography"
150068|NCT01364740|P1|Participant Flow|SmartWatch PMP-300E|"Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies)~Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device~In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography"
150069|NCT01364740|O1|Outcome|PMP-300E|Patient questionnaire data collected after one night with the PMP-300E
150070|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
150076|NCT01364649|B2|Baseline|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150077|NCT01364649|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150078|NCT01364649|P2|Participant Flow|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150079|NCT01364649|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150080|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150081|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150082|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150083|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150084|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150085|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150086|NCT01364649|E2|Reported Event|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
150087|NCT01364649|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
150088|NCT01364428|B3|Baseline|Total|Total of all reporting groups
150089|NCT01364428|B2|Baseline|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150090|NCT01364428|B1|Baseline|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150091|NCT01364428|P2|Participant Flow|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150092|NCT01364428|P1|Participant Flow|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150093|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150094|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150095|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150096|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150097|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
169014|NCT01291784|O3|Outcome|Sub C|Subject C
150098|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150099|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150100|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150101|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150102|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150103|NCT01364428|E2|Reported Event|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
150104|NCT01364428|E1|Reported Event|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
150105|NCT01364389|B4|Baseline|Total|Total of all reporting groups
150106|NCT01364389|B3|Baseline|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150107|NCT01364389|B2|Baseline|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150108|NCT01364389|B1|Baseline|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150109|NCT01364389|P3|Participant Flow|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150110|NCT01364389|P2|Participant Flow|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150111|NCT01364389|P1|Participant Flow|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150112|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150113|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150114|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150115|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150116|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150117|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150118|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150119|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150120|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150121|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150122|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150123|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150124|NCT01364389|E3|Reported Event|Prednisone 20mg|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
150125|NCT01364389|E2|Reported Event|AIN457 3mg/kg|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150126|NCT01364389|E1|Reported Event|ACZ885 3mg/kg|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
150127|NCT01364298|B3|Baseline|Total|Total of all reporting groups
150128|NCT01364298|B2|Baseline|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150129|NCT01364298|B1|Baseline|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150130|NCT01364298|P2|Participant Flow|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150131|NCT01364298|P1|Participant Flow|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150235|NCT01363700|P1|Participant Flow|Epinastine / Placebo Period1|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
169015|NCT01291784|O2|Outcome|Sub B|Subject B
150132|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150133|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150134|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150135|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150136|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150137|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150138|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150139|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150140|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150141|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150142|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150143|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150144|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150145|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150146|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
169016|NCT01291784|O1|Outcome|Sub A|Subject A
150147|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150148|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150149|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150150|NCT01364298|E2|Reported Event|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
150151|NCT01364298|E1|Reported Event|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
150152|NCT01364207|B1|Baseline|All Participants Who Completed Both Study Visits|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
150153|NCT01364207|P2|Participant Flow|Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
150154|NCT01364207|P1|Participant Flow|Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
150155|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
150156|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
150157|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
150158|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
150159|NCT01364207|E2|Reported Event|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
150160|NCT01364207|E1|Reported Event|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
150161|NCT01363986|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150162|NCT01363986|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150163|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150164|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150165|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150166|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150167|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150168|NCT01363986|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
150169|NCT01363908|B3|Baseline|Total|Total of all reporting groups
150170|NCT01363908|B2|Baseline|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150171|NCT01363908|B1|Baseline|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150172|NCT01363908|P2|Participant Flow|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150173|NCT01363908|P1|Participant Flow|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150174|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150175|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150176|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150177|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150178|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150179|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150180|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150181|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150182|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150183|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150184|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150185|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150186|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150187|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150188|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150189|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150236|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
150190|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150191|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150192|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150193|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150194|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150195|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150196|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150197|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150198|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150199|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150200|NCT01363908|E2|Reported Event|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150201|NCT01363908|E1|Reported Event|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
150202|NCT01363843|B1|Baseline|Study Arm|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
150203|NCT01363843|P1|Participant Flow|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
150237|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
150238|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
150239|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
150240|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
150241|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
169017|NCT01291784|O3|Outcome|Sub C|Subject C
150204|NCT01363843|O1|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
150205|NCT01363843|E1|Reported Event|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
150206|NCT01363765|B3|Baseline|Total|Total of all reporting groups
150207|NCT01363765|B2|Baseline|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
150208|NCT01363765|B1|Baseline|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
150209|NCT01363765|P2|Participant Flow|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
150210|NCT01363765|P1|Participant Flow|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
150211|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
150212|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
150213|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
150214|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
150215|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
150216|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
150217|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
150218|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period was submitted to this technology
150219|NCT01363765|E2|Reported Event|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
150220|NCT01363765|E1|Reported Event|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
150221|NCT01363713|B1|Baseline|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150222|NCT01363713|P1|Participant Flow|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150223|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150224|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150225|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150226|NCT01363713|E1|Reported Event|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
150227|NCT01363700|B4|Baseline|Total|Total of all reporting groups
150228|NCT01363700|B3|Baseline|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
150229|NCT01363700|B2|Baseline|Epinastine / Epinastine Period1|Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
150230|NCT01363700|B1|Baseline|Epinastine / Placebo Period1|Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
150231|NCT01363700|P5|Participant Flow|Epinastine / Placebo Period2|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
150232|NCT01363700|P4|Participant Flow|Olopatadine / Placebo Period2|Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
150233|NCT01363700|P3|Participant Flow|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
150234|NCT01363700|P2|Participant Flow|Epinastine / Epinastine Period1|Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.
150242|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
150243|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
150253|NCT01363661|B1|Baseline|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150254|NCT01363661|P2|Participant Flow|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150255|NCT01363661|P1|Participant Flow|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150256|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150257|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150258|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150259|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150260|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150261|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150262|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150263|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150264|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150265|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150266|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150267|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150268|NCT01363661|E2|Reported Event|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
150269|NCT01363661|E1|Reported Event|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
150270|NCT01363492|B1|Baseline|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150271|NCT01363492|P1|Participant Flow|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
150272|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150273|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150274|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150275|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150276|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150277|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150278|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150279|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150280|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150281|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
150282|NCT01363492|E1|Reported Event|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
150283|NCT01363479|B3|Baseline|Total|Total of all reporting groups
150284|NCT01363479|B2|Baseline|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
150285|NCT01363479|B1|Baseline|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
150286|NCT01363479|P2|Participant Flow|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
150287|NCT01363479|P1|Participant Flow|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
150288|NCT01363479|O2|Outcome|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
150289|NCT01363479|O1|Outcome|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
150290|NCT01363479|E2|Reported Event|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
150291|NCT01363479|E1|Reported Event|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
150292|NCT01363440|B4|Baseline|Total|Total of all reporting groups
150293|NCT01363440|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150294|NCT01363440|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150295|NCT01363440|B1|Baseline|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150296|NCT01363440|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150297|NCT01363440|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150298|NCT01363440|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150299|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150300|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150301|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150302|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150303|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150304|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150305|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150306|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150307|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150308|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150309|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150310|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150311|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150312|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150313|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150314|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150315|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150316|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150317|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150318|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150319|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150320|NCT01363440|E6|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150321|NCT01363440|E5|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
150322|NCT01363440|E4|Reported Event|Control (Week 0 to Week 148)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150323|NCT01363440|E3|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
150324|NCT01363440|E2|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
150325|NCT01363440|E1|Reported Event|Control (Week 0 to Week 100)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
150326|NCT01363401|B3|Baseline|Total|Total of all reporting groups
150327|NCT01363401|B2|Baseline|No Treatment|"No treatment with HYNR-CS inj.~Take each 50mg 1 hour before a meal or 2 hours after a meal at least at an interval of 12 hours, 28 weeks(12 weeks of run-in phase plus 16 weeks of treatment phase)"
150328|NCT01363401|B1|Baseline|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150329|NCT01363401|P2|Participant Flow|No Treatment|No treatment with HYNR-CS inj.
150330|NCT01363401|P1|Participant Flow|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150331|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
150332|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150333|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
150334|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150335|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
150336|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150337|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
150338|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150339|NCT01363401|E2|Reported Event|No Treatment|No treatment with HYNR-CS inj.
150340|NCT01363401|E1|Reported Event|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
150341|NCT01363349|B3|Baseline|Total|Total of all reporting groups
150342|NCT01363349|B2|Baseline|Risperidone|"2-6 mg, 6 months~Risperidone"
150343|NCT01363349|B1|Baseline|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
150344|NCT01363349|P2|Participant Flow|Risperidone|"2-6 mg, 6 months~Risperidone"
150345|NCT01363349|P1|Participant Flow|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
150346|NCT01363349|O2|Outcome|Risperidone|"2-6 mg, 6 months~Risperidone"
150347|NCT01363349|O1|Outcome|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
150348|NCT01363349|E2|Reported Event|Risperidone|"2-6 mg, 6 months~Risperidone"
150349|NCT01363349|E1|Reported Event|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
150350|NCT01363076|B3|Baseline|Total|Total of all reporting groups
150351|NCT01363076|B2|Baseline|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150352|NCT01363076|B1|Baseline|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150353|NCT01363076|P2|Participant Flow|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150354|NCT01363076|P1|Participant Flow|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150355|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150356|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150357|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150358|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150359|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150360|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150361|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150362|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150363|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150364|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150365|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150366|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150367|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150368|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150369|NCT01363076|E2|Reported Event|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
150370|NCT01363076|E1|Reported Event|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
150371|NCT01363050|B1|Baseline|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150372|NCT01363050|P1|Participant Flow|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150373|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150374|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150375|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150822|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150376|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150377|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150378|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150379|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150380|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150381|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150382|NCT01363050|E1|Reported Event|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
150383|NCT01363011|B3|Baseline|Total|Total of all reporting groups
150384|NCT01363011|B2|Baseline|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150385|NCT01363011|B1|Baseline|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150386|NCT01363011|P2|Participant Flow|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to cobicistat (Tybost®; COBI) 150 mg, while continuing the other components of their ARV regimen (atazanavir (ATV) 300 mg or darunavir (DRV) 800 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTI)) for up to 96 weeks. These 2 NRTIs may have included abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF), administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150387|NCT01363011|P1|Participant Flow|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150388|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150389|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150390|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150391|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150392|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150823|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150393|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150394|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150395|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150396|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150397|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150398|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150399|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150400|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150401|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150402|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150403|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150404|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150405|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150659|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150406|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150407|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150408|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150409|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150410|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150411|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150412|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150413|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150414|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150415|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150416|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150417|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150418|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150419|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150420|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150421|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150422|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150423|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150424|NCT01363011|E2|Reported Event|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
150425|NCT01363011|E1|Reported Event|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
150426|NCT01362946|B1|Baseline|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150427|NCT01362946|P2|Participant Flow|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
150428|NCT01362946|P1|Participant Flow|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
150429|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
150430|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
150431|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150432|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150459|NCT01362946|E1|Reported Event|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
150433|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150434|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150435|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150436|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150437|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150438|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150439|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150440|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150441|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150442|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150443|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150444|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150445|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150460|NCT01362907|B1|Baseline|Overall|All enrolled participants
150446|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150447|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150448|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150449|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150450|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150451|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150452|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150453|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150454|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150455|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150456|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150457|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
150458|NCT01362946|E2|Reported Event|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
150660|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150461|NCT01362907|P2|Participant Flow|Etafilcon A / Delefilcon A|Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
150462|NCT01362907|P1|Participant Flow|Delefilcon A / Etafilcon A|Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
150463|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150464|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150465|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150466|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150467|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150468|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150469|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150470|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150471|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150472|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150473|NCT01362907|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150474|NCT01362907|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150475|NCT01362894|B1|Baseline|Overall|All enrolled and dispensed participants.
150476|NCT01362894|P2|Participant Flow|Etafilcon A / Nelfilcon A|Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
150477|NCT01362894|P1|Participant Flow|Nelfilcon A / Etafilcon A|Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
150478|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150479|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150480|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150481|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150482|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150483|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150484|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150485|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150486|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150487|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150488|NCT01362894|E2|Reported Event|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150489|NCT01362894|E1|Reported Event|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
150490|NCT01362530|B3|Baseline|Total|Total of all reporting groups
150491|NCT01362530|B2|Baseline|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150492|NCT01362530|B1|Baseline|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150493|NCT01362530|P2|Participant Flow|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150494|NCT01362530|P1|Participant Flow|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150495|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150547|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150496|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150497|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150498|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150499|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150500|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150501|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150502|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
150503|NCT01362530|E3|Reported Event|Aprepitant Regimen Cycles 2-6|Participants completing Cycle 1 from either the aprepitant or the control regimen who meet eligibility criteria: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
150504|NCT01362530|E2|Reported Event|Control Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
150505|NCT01362530|E1|Reported Event|Aprepitant Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
150506|NCT01362517|B1|Baseline|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
150507|NCT01362517|P1|Participant Flow|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
150508|NCT01362517|O1|Outcome|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
150509|NCT01362517|O1|Outcome|Quinvaxem|
150510|NCT01362517|O1|Outcome|Quinvaxem|
150511|NCT01362517|E3|Reported Event|Third Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 4 months of age"
150512|NCT01362517|E2|Reported Event|Second Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 3 months of age"
150513|NCT01362517|E1|Reported Event|First Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 2 months of age"
150514|NCT01362491|B4|Baseline|Total|Total of all reporting groups
150515|NCT01362491|B3|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150516|NCT01362491|B2|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150517|NCT01362491|B1|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150518|NCT01362491|P3|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150519|NCT01362491|P2|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150520|NCT01362491|P1|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150521|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150522|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150523|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150524|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150525|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150526|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150527|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150528|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150529|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150530|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150531|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150532|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150533|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150534|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150535|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150536|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150537|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150538|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150539|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150540|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150541|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150542|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150543|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150544|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150545|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150546|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150824|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150548|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150549|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150550|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150551|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150552|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150553|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150554|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150555|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150556|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150557|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150558|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150559|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150560|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150561|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150562|NCT01362491|O2|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150563|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150564|NCT01362491|E3|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150565|NCT01362491|E2|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
150566|NCT01362491|E1|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
150567|NCT01362439|B1|Baseline|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150568|NCT01362439|P1|Participant Flow|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150569|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150570|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150571|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150572|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150573|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150574|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150575|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150576|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150577|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150578|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150579|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150580|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150581|NCT01362439|E1|Reported Event|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
150582|NCT01362296|B3|Baseline|Total|Total of all reporting groups
150583|NCT01362296|B2|Baseline|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150584|NCT01362296|B1|Baseline|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150585|NCT01362296|P4|Participant Flow|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150586|NCT01362296|P3|Participant Flow|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150587|NCT01362296|P2|Participant Flow|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150588|NCT01362296|P1|Participant Flow|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150589|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150590|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150591|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150592|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150593|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150594|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150825|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
150595|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150596|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150597|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150598|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150599|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150600|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150601|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150602|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150603|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150604|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150605|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150606|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150607|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150608|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150609|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150657|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150610|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150611|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150612|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150613|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150614|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150615|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150616|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150617|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150618|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150619|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150620|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150621|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150622|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150623|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150624|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150658|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150625|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150626|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150627|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
150628|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
150629|NCT01362296|E4|Reported Event|Docetaxel 75 mg/m^2 in CP|Participants who experienced disease progression in the RP were given the option of crossing over to docetaxel 75 mg/m^2 and continuing in the CP.
150630|NCT01362296|E3|Reported Event|GSK1120212 2 mg in CP|Participants who experienced disease progression in the RP were given the option of crossing over to GSK1120212 2 mg and continuing in the Cross-over Phase (CP).
150631|NCT01362296|E2|Reported Event|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced.
150632|NCT01362296|E1|Reported Event|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced.
150633|NCT01362244|B3|Baseline|Total|Total of all reporting groups
150634|NCT01362244|B2|Baseline|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150635|NCT01362244|B1|Baseline|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
150636|NCT01362244|P2|Participant Flow|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150637|NCT01362244|P1|Participant Flow|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150638|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150639|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150640|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150641|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150642|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150643|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150644|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150645|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150646|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150647|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150648|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150649|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150650|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150651|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150652|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150653|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150654|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150655|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150656|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
169018|NCT01291784|O2|Outcome|Sub B|Subject B
150661|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150662|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150663|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150664|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150665|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150666|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150667|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150668|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150669|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150670|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150671|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150672|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150673|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150674|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150675|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150676|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150677|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150678|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150679|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150680|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150681|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150682|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150683|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150684|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150685|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150686|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150687|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150688|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150689|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150690|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150691|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150692|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150693|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150694|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150695|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150696|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150697|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150698|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150699|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150700|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150701|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
151615|NCT01358357|P2|Participant Flow|Placebo|Placebo: 20-80 mg flexible dose
150702|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150703|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150704|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
150705|NCT01362244|E2|Reported Event|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
150706|NCT01362244|E1|Reported Event|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
150707|NCT01362192|B1|Baseline|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150708|NCT01362192|P1|Participant Flow|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150709|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150710|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150711|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150712|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150713|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150714|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150715|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150716|NCT01362192|E1|Reported Event|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
150717|NCT01362140|B3|Baseline|Total|Total of all reporting groups
150718|NCT01362140|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150719|NCT01362140|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150720|NCT01362140|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150721|NCT01362140|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150722|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150723|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150724|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150725|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150726|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150727|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150728|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150729|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150730|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150731|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150732|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150733|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150734|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150735|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150736|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150737|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150738|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150739|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150740|NCT01362140|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
150741|NCT01362140|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
150742|NCT01362062|B3|Baseline|Total|Total of all reporting groups
150743|NCT01362062|B2|Baseline|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
150744|NCT01362062|B1|Baseline|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150745|NCT01362062|P2|Participant Flow|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
150767|NCT01361854|E2|Reported Event|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed in the sleep lab"
169019|NCT01291784|O1|Outcome|Sub A|Subject A
150746|NCT01362062|P1|Participant Flow|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150747|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150748|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150749|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150750|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150751|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150752|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150753|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150754|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150755|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150756|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150757|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150758|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150759|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
150760|NCT01362062|O1|Outcome|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
150761|NCT01362062|E1|Reported Event|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
150762|NCT01361854|B1|Baseline|Polysomnography for Suspicion of SDB|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital"
150763|NCT01361854|P2|Participant Flow|Hospital Hook-up First, Then Home Hook-up|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks"
150764|NCT01361854|P1|Participant Flow|Home Hook-up First Then Hook-up in the Hospital|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home first.~Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks"
150765|NCT01361854|O2|Outcome|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography:home polysomnography with in-lab hook up first"
150766|NCT01361854|O1|Outcome|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with home hook-up first"
150819|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150768|NCT01361854|E1|Reported Event|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home"
150769|NCT01361633|B3|Baseline|Total|Total of all reporting groups
150770|NCT01361633|B2|Baseline|Sugar Pill|Placebo Control
150771|NCT01361633|B1|Baseline|Medication|250 mg d-cycloserine
150772|NCT01361633|P2|Participant Flow|Sugar Pill|Placebo Control
150773|NCT01361633|P1|Participant Flow|Medication|250 mg d-cycloserine
150774|NCT01361633|O2|Outcome|Sugar Pill|Placebo control
150775|NCT01361633|O1|Outcome|Medication|250mg d-cycloserine
150776|NCT01361633|E2|Reported Event|Sugar Pill|Placebo Control
150777|NCT01361633|E1|Reported Event|Medication|250 mg d-cycloserine
150778|NCT01361620|B1|Baseline|Aspirin|All subjects took 7-10 days of 81 mg aspirin
150779|NCT01361620|P1|Participant Flow|Aspirin|All subjects took 7-10 days of 81 mg aspirin
150780|NCT01361620|O1|Outcome|Aspirin|All subjects took 7-10 days of 81 mg aspirin
150781|NCT01361620|E1|Reported Event|Aspirin|All subjects took 7-10 days of 81 mg aspirin
150782|NCT01361594|B3|Baseline|Total|Total of all reporting groups
150783|NCT01361594|B2|Baseline|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
150784|NCT01361594|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
150785|NCT01361594|P2|Participant Flow|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
150786|NCT01361594|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
150787|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
150788|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
150789|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
150790|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
150791|NCT01361594|E2|Reported Event|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
150792|NCT01361594|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
150793|NCT01361568|B7|Baseline|Total|Total of all reporting groups
150794|NCT01361568|B6|Baseline|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
150795|NCT01361568|B5|Baseline|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
150796|NCT01361568|B4|Baseline|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150797|NCT01361568|B3|Baseline|CR845-CR845|CR845 administered both preoperatively and postoperatively
150798|NCT01361568|B2|Baseline|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150799|NCT01361568|B1|Baseline|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150800|NCT01361568|P6|Participant Flow|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
150801|NCT01361568|P5|Participant Flow|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
150802|NCT01361568|P4|Participant Flow|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150803|NCT01361568|P3|Participant Flow|CR845-CR845|CR845 administered both preoperatively and postoperatively
150804|NCT01361568|P2|Participant Flow|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150805|NCT01361568|P1|Participant Flow|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150806|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
150807|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
150808|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
150809|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
150810|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
150811|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only either preoperatively and/or postoperatively
150812|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150813|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
150814|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150815|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150816|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150817|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
150818|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150826|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150827|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150828|NCT01361568|E6|Reported Event|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
150829|NCT01361568|E5|Reported Event|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
150830|NCT01361568|E4|Reported Event|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
150831|NCT01361568|E3|Reported Event|CR845-CR845|CR845 administered both preoperatively and postoperatively
150832|NCT01361568|E2|Reported Event|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
150833|NCT01361568|E1|Reported Event|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
150834|NCT01361464|B1|Baseline|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150835|NCT01361464|P1|Participant Flow|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150836|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150837|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150838|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150839|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150840|NCT01361464|E1|Reported Event|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
150841|NCT01361308|B3|Baseline|Total|Total of all reporting groups
150842|NCT01361308|B2|Baseline|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150843|NCT01361308|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150844|NCT01361308|P2|Participant Flow|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150845|NCT01361308|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150846|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150847|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150848|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150849|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150850|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150851|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150852|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150853|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150854|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150855|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150856|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150857|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150858|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150859|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150860|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
151199|NCT01359904|B1|Baseline|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
150861|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150862|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150863|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150864|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150865|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150866|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150867|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150868|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150869|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150870|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150871|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150872|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150873|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150874|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150875|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150876|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150877|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150878|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150879|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150880|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150881|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
150882|NCT01361308|E2|Reported Event|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150883|NCT01361308|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
150884|NCT01361126|B3|Baseline|Total|Total of all reporting groups
150885|NCT01361126|B2|Baseline|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
150886|NCT01361126|B1|Baseline|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
150887|NCT01361126|P2|Participant Flow|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
150888|NCT01361126|P1|Participant Flow|Prophylactic|For the PK evaluation, subjects received a single intravenous (IV) infusion of Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
150889|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
150890|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150891|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150892|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150893|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150894|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150895|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150896|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150897|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
150898|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
150899|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
150900|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
150901|NCT01361126|E1|Reported Event|All Subjects|Subjects received rIX-FP administered by IV infusion as prophylactic treatment once a week or on demand to treat bleeding episodes for 20 weeks.
150902|NCT01361048|B4|Baseline|Total|Total of all reporting groups
150903|NCT01361048|B3|Baseline|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
150904|NCT01361048|B2|Baseline|Neo Penotran Forte Twice a Day|neo penotran forte vaginal suppository twice a day for 7 days
150905|NCT01361048|B1|Baseline|Oral Metronidazole|control arm
150906|NCT01361048|P3|Participant Flow|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
150907|NCT01361048|P2|Participant Flow|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
150908|NCT01361048|P1|Participant Flow|Oral Metronidazole|control arm
150909|NCT01361048|O3|Outcome|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
150910|NCT01361048|O2|Outcome|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
150911|NCT01361048|O1|Outcome|Oral Metronidazole 2 gm Stat Dose|control arm
150912|NCT01361048|E3|Reported Event|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
150913|NCT01361048|E2|Reported Event|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
150914|NCT01361048|E1|Reported Event|Oral Metronidazole|control arm
150915|NCT01361009|B1|Baseline|Pramipexole Goup|
150916|NCT01361009|P1|Participant Flow|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150917|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150918|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150919|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150920|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150921|NCT01361009|E1|Reported Event|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
150922|NCT01360840|B4|Baseline|Total|Total of all reporting groups
150923|NCT01360840|B3|Baseline|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150924|NCT01360840|B2|Baseline|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150925|NCT01360840|B1|Baseline|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
151063|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
150926|NCT01360840|P3|Participant Flow|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150927|NCT01360840|P2|Participant Flow|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150928|NCT01360840|P1|Participant Flow|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150929|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150930|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150931|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150932|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150933|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150934|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150935|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150936|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150937|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150997|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
169020|NCT01291784|E3|Reported Event|Sub C|Subject C
150938|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150939|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150940|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150941|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150942|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150943|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150944|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150945|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150946|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150947|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150948|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150949|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150998|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151064|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
150950|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150951|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150952|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150953|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150954|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150955|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150956|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150957|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150958|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150959|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150960|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150961|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150999|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151065|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
150962|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150963|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150964|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150965|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150966|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150967|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150968|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150969|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150970|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150971|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150972|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150973|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
151000|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151066|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
150974|NCT01360840|E3|Reported Event|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150975|NCT01360840|E2|Reported Event|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 milligram (mg) (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150976|NCT01360840|E1|Reported Event|Placebo + SoC|Subjects were administered with placebo 0.9 percent (%) sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
150977|NCT01360645|B3|Baseline|Total|Total of all reporting groups
150978|NCT01360645|B2|Baseline|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150979|NCT01360645|B1|Baseline|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150980|NCT01360645|P4|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
150981|NCT01360645|P3|Participant Flow|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150982|NCT01360645|P2|Participant Flow|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150983|NCT01360645|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks
150984|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150985|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150986|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150987|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150988|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150989|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150990|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150991|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150992|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150993|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150994|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150995|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
150996|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151067|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151001|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151002|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151003|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151004|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151005|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151006|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151007|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151008|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151009|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151010|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151011|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151012|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151013|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151014|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151015|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151016|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151017|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151018|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151019|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151020|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151021|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151022|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151023|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151024|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151025|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151026|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151027|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151028|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151029|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151030|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151031|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151032|NCT01360645|E2|Reported Event|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151033|NCT01360645|E1|Reported Event|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
151034|NCT01360632|B4|Baseline|Total|Total of all reporting groups
151035|NCT01360632|B3|Baseline|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
151036|NCT01360632|B2|Baseline|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
151037|NCT01360632|B1|Baseline|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
151038|NCT01360632|P5|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
151039|NCT01360632|P4|Participant Flow|Double-blind Placebo + ADT|In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.
151040|NCT01360632|P3|Participant Flow|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
151041|NCT01360632|P2|Participant Flow|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole of [1mg (milligram)] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).
151042|NCT01360632|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.
151043|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151044|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151045|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151046|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151047|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151048|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151049|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151050|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151051|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151052|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151053|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151054|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151055|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151056|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151057|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151058|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151059|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151060|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151061|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151062|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
169021|NCT01291784|E2|Reported Event|Sub B|Subject B
151068|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151069|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151070|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151071|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151072|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151073|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151074|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151075|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151076|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151077|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151078|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151079|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151080|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151081|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151082|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151083|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151084|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151085|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151086|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151087|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151088|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151089|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151090|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151091|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151092|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151093|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151094|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151095|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151096|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151097|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151098|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151099|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151100|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151101|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151102|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151103|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151104|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151105|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151106|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151107|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151108|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151109|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151110|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151198|NCT01359904|B2|Baseline|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151111|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151112|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
151113|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
151114|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
151115|NCT01360632|E3|Reported Event|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
151116|NCT01360632|E2|Reported Event|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
151117|NCT01360632|E1|Reported Event|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
151118|NCT01360021|B4|Baseline|Total|Total of all reporting groups
151119|NCT01360021|B3|Baseline|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151120|NCT01360021|B2|Baseline|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151121|NCT01360021|B1|Baseline|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151122|NCT01360021|P3|Participant Flow|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151123|NCT01360021|P2|Participant Flow|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151124|NCT01360021|P1|Participant Flow|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151125|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151126|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151127|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151128|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151129|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151130|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151131|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151132|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151133|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151134|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151135|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151136|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151137|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151138|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151139|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151140|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
151141|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
151142|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
151143|NCT01360021|E3|Reported Event|Symbicort pMDI|
151144|NCT01360021|E2|Reported Event|Symbicort BA MDI|
151145|NCT01360021|E1|Reported Event|Budesonide|
151146|NCT01359943|B4|Baseline|Total|Total of all reporting groups
151147|NCT01359943|B3|Baseline|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151148|NCT01359943|B2|Baseline|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151149|NCT01359943|B1|Baseline|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151150|NCT01359943|P3|Participant Flow|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151151|NCT01359943|P2|Participant Flow|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151152|NCT01359943|P1|Participant Flow|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151153|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151154|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151155|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151156|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151157|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151158|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151159|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151160|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151161|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151969|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151162|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151163|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151164|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151165|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151166|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151167|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151168|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151169|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151170|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151171|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151172|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151173|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151174|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151175|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151176|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151177|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151178|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151179|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151180|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151181|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151182|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151183|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151184|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151185|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151186|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151187|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151188|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151189|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151190|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151191|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151192|NCT01359943|E5|Reported Event|AIN457 Pooled Treatment Groups - Follow-up Period|Follow-up period: week 52 through week 60 - AIN457 150 mg sc open label
151193|NCT01359943|E4|Reported Event|AIN457 Pooled Treatment Groups - Open Label Period|Week 16 through week 52: AIN457 150 mg s.c. open label
151194|NCT01359943|E3|Reported Event|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
151195|NCT01359943|E2|Reported Event|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151196|NCT01359943|E1|Reported Event|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
151197|NCT01359904|B3|Baseline|Total|Total of all reporting groups
151200|NCT01359904|P2|Participant Flow|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151201|NCT01359904|P1|Participant Flow|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
151202|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151203|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
151204|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151205|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
151206|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151207|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
151208|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151209|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
151210|NCT01359904|E2|Reported Event|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
151211|NCT01359904|E1|Reported Event|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
151212|NCT01359748|B5|Baseline|Total|Total of all reporting groups
151213|NCT01359748|B4|Baseline|Wrist Size >=17.75|Subjects, males or females, with wrist size specified.
151214|NCT01359748|B3|Baseline|Wrist Size >=16.5 Cm|Subjects, males or females, with wrist size specified.
151215|NCT01359748|B2|Baseline|Wrist Size<=16.40 Cm|Subjects, males or females, with wrist size specified.
151216|NCT01359748|B1|Baseline|Wrist Size <=14.25Cm|Subjects, males or females, with wrist size specified.
151217|NCT01359748|P4|Participant Flow|Subjects With Wrist Size >=17.75Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
151218|NCT01359748|P3|Participant Flow|Subjects With Wrist Size >=16.50Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
151219|NCT01359748|P2|Participant Flow|Subjects With Wrist Size <=14.25Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
151220|NCT01359748|P1|Participant Flow|Subjects With Wrist Size >=14.26Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
151221|NCT01359748|O1|Outcome|Subjects|Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
151222|NCT01359748|O1|Outcome|Subjects|Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
151223|NCT01359748|E4|Reported Event|Wrist Size >=17.75 Cm|Subjects with wrist size equal or higher than 17.75 Cm
151224|NCT01359748|E3|Reported Event|Wrist Size >=16.5 Cm|Subjects with wrist size equal or higher than 16.5 Cm
151225|NCT01359748|E2|Reported Event|Wrist Size <=16.4Cm|Subjects with wrist size equal or less than 16.40 Cm
151226|NCT01359748|E1|Reported Event|Wrist Size <=14.25 Cm|Subjects with wrist size equal or less than 14.25 Cm
151227|NCT01359644|B11|Baseline|Total|Total of all reporting groups
151228|NCT01359644|B10|Baseline|Treatment J: Sofosbuvir +Daclatasvir +Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
151229|NCT01359644|B9|Baseline|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151230|NCT01359644|B8|Baseline|Treatment H: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
151231|NCT01359644|B7|Baseline|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
151232|NCT01359644|B6|Baseline|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
151233|NCT01359644|B5|Baseline|Treatment E: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
151234|NCT01359644|B4|Baseline|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
151235|NCT01359644|B3|Baseline|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151236|NCT01359644|B2|Baseline|Treatment: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151237|NCT01359644|B1|Baseline|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151238|NCT01359644|P10|Participant Flow|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
151239|NCT01359644|P9|Participant Flow|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151240|NCT01359644|P8|Participant Flow|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
151241|NCT01359644|P7|Participant Flow|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
151242|NCT01359644|P6|Participant Flow|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
151243|NCT01359644|P5|Participant Flow|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
151244|NCT01359644|P4|Participant Flow|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151245|NCT01359644|P3|Participant Flow|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151246|NCT01359644|P2|Participant Flow|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151247|NCT01359644|P1|Participant Flow|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151248|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
151249|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
151250|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
151251|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
151252|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
151253|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
151254|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
151255|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
151256|NCT01359644|O10|Outcome|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
151257|NCT01359644|O9|Outcome|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
151662|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151258|NCT01359644|O8|Outcome|Treatment H: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
151259|NCT01359644|O7|Outcome|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
151260|NCT01359644|O6|Outcome|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
151261|NCT01359644|O5|Outcome|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
151262|NCT01359644|O4|Outcome|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
151263|NCT01359644|O3|Outcome|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151264|NCT01359644|O2|Outcome|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151265|NCT01359644|O1|Outcome|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151266|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
151267|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
151268|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
151269|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
151270|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
151271|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
151272|NCT01359644|O3|Outcome|Telaprevir/Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
151273|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
151274|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.
151275|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
151276|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
151277|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
151278|NCT01359644|E10|Reported Event|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
151279|NCT01359644|E9|Reported Event|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
169022|NCT01291784|E1|Reported Event|Sub A|Subject A
151280|NCT01359644|E8|Reported Event|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
151281|NCT01359644|E7|Reported Event|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
151282|NCT01359644|E6|Reported Event|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
151283|NCT01359644|E5|Reported Event|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
151284|NCT01359644|E4|Reported Event|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151285|NCT01359644|E3|Reported Event|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
151286|NCT01359644|E2|Reported Event|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
151287|NCT01359644|E1|Reported Event|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
151288|NCT01359449|B3|Baseline|Total|Total of all reporting groups
151289|NCT01359449|B2|Baseline|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151290|NCT01359449|B1|Baseline|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151291|NCT01359449|P2|Participant Flow|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151292|NCT01359449|P1|Participant Flow|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151293|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151294|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151295|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151296|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151297|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151298|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151299|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151300|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151301|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151302|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151303|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151304|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151305|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151306|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151713|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151307|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151308|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151309|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151310|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151311|NCT01359449|E2|Reported Event|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
151312|NCT01359449|E1|Reported Event|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
151313|NCT01359371|B1|Baseline|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
151314|NCT01359371|P1|Participant Flow|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
151315|NCT01359371|O2|Outcome|Number of Times Reached for Peer Telephone Counseling:3-4times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 3-4 times for peer telephone counseling.
151316|NCT01359371|O1|Outcome|Number of Times Reached for Peer Telephone Counseling:0-2times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 0-2 times for peer telephone counseling.
151317|NCT01359371|E1|Reported Event|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
151318|NCT01359254|B3|Baseline|Total|Total of all reporting groups
151319|NCT01359254|B2|Baseline|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
151320|NCT01359254|B1|Baseline|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
151321|NCT01359254|P2|Participant Flow|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
151322|NCT01359254|P1|Participant Flow|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
151323|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
151324|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
151325|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
151326|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
151327|NCT01359254|E2|Reported Event|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
151328|NCT01359254|E1|Reported Event|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
151329|NCT01359150|B3|Baseline|Total|Total of all reporting groups
151330|NCT01359150|B2|Baseline|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151970|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151331|NCT01359150|B1|Baseline|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151332|NCT01359150|P2|Participant Flow|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151333|NCT01359150|P1|Participant Flow|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151334|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151335|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151336|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151337|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151338|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151339|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151340|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151341|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151342|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151343|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151344|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151345|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151346|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151347|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151348|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151349|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151350|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151351|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151971|NCT01357239|O2|Outcome|Placebo|2 capsules of placebo per intake
151352|NCT01359150|E2|Reported Event|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151353|NCT01359150|E1|Reported Event|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
151354|NCT01359111|B1|Baseline|Intradermal Adapter|Saline injection with intradermal adapter
151355|NCT01359111|P1|Participant Flow|Intradermal Adapter|Saline injection with intradermal adapter
151356|NCT01359111|O2|Outcome|Bevel Down|Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
151357|NCT01359111|O1|Outcome|Bevel Up|Saline injection with intradermal adapter used with needle bevel oriented up relative to the surface of the skin
151358|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
151359|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
151360|NCT01359111|E1|Reported Event|Intradermal Adapter|Saline injection with intradermal adapter
151361|NCT01358864|B9|Baseline|Total|Total of all reporting groups
151362|NCT01358864|B8|Baseline|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151363|NCT01358864|B7|Baseline|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151364|NCT01358864|B6|Baseline|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151365|NCT01358864|B5|Baseline|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151366|NCT01358864|B4|Baseline|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151367|NCT01358864|B3|Baseline|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151368|NCT01358864|B2|Baseline|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151369|NCT01358864|B1|Baseline|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151370|NCT01358864|P8|Participant Flow|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151371|NCT01358864|P7|Participant Flow|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151372|NCT01358864|P6|Participant Flow|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151373|NCT01358864|P5|Participant Flow|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151374|NCT01358864|P4|Participant Flow|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151375|NCT01358864|P3|Participant Flow|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151376|NCT01358864|P2|Participant Flow|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151663|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151377|NCT01358864|P1|Participant Flow|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151378|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151379|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151380|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151381|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151382|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151383|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151384|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151385|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151386|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151387|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151388|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151389|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151390|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151391|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151392|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151393|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151394|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151395|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151396|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151417|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151397|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151398|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151399|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151400|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151401|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151402|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151403|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151404|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151405|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151406|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151407|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151408|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151409|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151410|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151411|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151412|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151413|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151414|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151415|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151416|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
169269|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
151418|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151419|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151420|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151421|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151422|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151423|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151424|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151425|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151426|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151427|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151428|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151429|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151430|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151431|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151432|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151433|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151434|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151435|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151436|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151437|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151484|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151438|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151439|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151440|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151441|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151442|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151443|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151444|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151445|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151446|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151447|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151448|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151449|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151450|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151451|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151452|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151453|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
151454|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151455|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151456|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151485|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151664|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151457|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151458|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151459|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151460|NCT01358864|E5|Reported Event|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151461|NCT01358864|E4|Reported Event|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
151462|NCT01358864|E3|Reported Event|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151463|NCT01358864|E2|Reported Event|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
151464|NCT01358864|E1|Reported Event|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
151465|NCT01358825|B3|Baseline|Total|Total of all reporting groups
151466|NCT01358825|B2|Baseline|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151467|NCT01358825|B1|Baseline|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151468|NCT01358825|P2|Participant Flow|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151469|NCT01358825|P1|Participant Flow|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151470|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151471|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151472|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151473|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151474|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151475|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151476|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151477|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151478|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151479|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151480|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151481|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151482|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151483|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151486|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151487|NCT01358825|E2|Reported Event|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
151488|NCT01358825|E1|Reported Event|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
151489|NCT01358734|B4|Baseline|Total|Total of all reporting groups
151490|NCT01358734|B3|Baseline|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151491|NCT01358734|B2|Baseline|Azacitidine + Lenalidomide|Azacitidine 75 mg/m^2/ daily subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151492|NCT01358734|B1|Baseline|Lenalidomide|Lenalidomide 50 mg/day by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg daily PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily
151493|NCT01358734|P3|Participant Flow|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151494|NCT01358734|P2|Participant Flow|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151495|NCT01358734|P1|Participant Flow|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151496|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151497|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151498|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151499|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151500|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151501|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151502|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151503|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151504|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151505|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151506|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151507|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151508|NCT01358734|E3|Reported Event|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
151509|NCT01358734|E2|Reported Event|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
151510|NCT01358734|E1|Reported Event|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
151511|NCT01358708|B3|Baseline|Total|Total of all reporting groups
151512|NCT01358708|B2|Baseline|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151513|NCT01358708|B1|Baseline|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151514|NCT01358708|P2|Participant Flow|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151515|NCT01358708|P1|Participant Flow|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151516|NCT01358708|O3|Outcome|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151972|NCT01357239|O1|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151517|NCT01358708|O2|Outcome|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151518|NCT01358708|O1|Outcome|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151519|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151520|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151521|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151522|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151523|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151524|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151525|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151526|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151527|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151528|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151529|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151530|NCT01358708|E3|Reported Event|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151531|NCT01358708|E2|Reported Event|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151532|NCT01358708|E1|Reported Event|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
151533|NCT01358578|B5|Baseline|Total|Total of all reporting groups
151534|NCT01358578|B4|Baseline|Etanercept|Etanercept
151535|NCT01358578|B3|Baseline|Placebo|Placebo
151536|NCT01358578|B2|Baseline|AIN457 300mg|AIN457 300mg
151537|NCT01358578|B1|Baseline|AIN457 150mg|AIN457 150mg
151538|NCT01358578|P6|Participant Flow|AIN457 300mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
151539|NCT01358578|P5|Participant Flow|AIN457 150mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
151540|NCT01358578|P4|Participant Flow|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
151541|NCT01358578|P3|Participant Flow|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
151542|NCT01358578|P2|Participant Flow|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151543|NCT01358578|P1|Participant Flow|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151544|NCT01358578|O6|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
151545|NCT01358578|O5|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
151546|NCT01358578|O4|Outcome|PLACEBO-300 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
151547|NCT01358578|O3|Outcome|PLACEBO-150 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
151548|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151549|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151550|NCT01358578|O3|Outcome|Etanercept|etanercept 50 mg twice per week until Week 12
151551|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151552|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151553|NCT01358578|O3|Outcome|Placebo|AIN457A exact match Placebo
151554|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151555|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151556|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
151557|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151558|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151559|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
151560|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151561|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151562|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
151563|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151564|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151565|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
151566|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151567|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151568|NCT01358578|O4|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
151569|NCT01358578|O3|Outcome|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
151570|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151571|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151613|NCT01358357|B1|Baseline|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151572|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
151573|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151574|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151575|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
151576|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151577|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
151578|NCT01358578|E14|Reported Event|FOLLOW UP-Etanercept|FOLLOW UP-Etanercept
151579|NCT01358578|E13|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
151580|NCT01358578|E12|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
151581|NCT01358578|E11|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
151582|NCT01358578|E10|Reported Event|ENTIRE-Etanercept|ENTIRE-Etanercept
151583|NCT01358578|E9|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
151584|NCT01358578|E8|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
151585|NCT01358578|E7|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
151586|NCT01358578|E6|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
151587|NCT01358578|E5|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
151588|NCT01358578|E4|Reported Event|INDUCTION-Etanercept|INDUCTION-Etanercept
151589|NCT01358578|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
151590|NCT01358578|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
151591|NCT01358578|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
151592|NCT01358526|B3|Baseline|Total|Total of all reporting groups
151593|NCT01358526|B2|Baseline|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151594|NCT01358526|B1|Baseline|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151595|NCT01358526|P3|Participant Flow|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151596|NCT01358526|P2|Participant Flow|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151597|NCT01358526|P1|Participant Flow|Open-label Titration OXN|The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
151598|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151599|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151600|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151601|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151602|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151603|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151604|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151605|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151606|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151607|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151608|NCT01358526|E3|Reported Event|Double-blind OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151609|NCT01358526|E2|Reported Event|Double-blind Placebo|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
151610|NCT01358526|E1|Reported Event|Open-label Titration OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
151611|NCT01358357|B3|Baseline|Total|Total of all reporting groups
151612|NCT01358357|B2|Baseline|Placebo|Placebo: 20-80 mg flexible dose
151614|NCT01358357|P3|Participant Flow|All Subjects|During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
151616|NCT01358357|P1|Participant Flow|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151617|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151618|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151619|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151620|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151621|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151622|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151623|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151624|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151625|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151626|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151627|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151628|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151629|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151630|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151631|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151632|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151633|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151634|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151635|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151636|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151637|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151638|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151639|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151640|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151641|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151642|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151643|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
151644|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151645|NCT01358357|E3|Reported Event|All Subjects|During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
151646|NCT01358357|E2|Reported Event|Placebo|Placebo: 20-80 mg flexible dose
151647|NCT01358357|E1|Reported Event|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
151648|NCT01358175|B4|Baseline|Total|Total of all reporting groups
151649|NCT01358175|B3|Baseline|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151650|NCT01358175|B2|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151651|NCT01358175|B1|Baseline|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151652|NCT01358175|P3|Participant Flow|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151653|NCT01358175|P2|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151654|NCT01358175|P1|Participant Flow|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151655|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151656|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151657|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151658|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151659|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151660|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151661|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151665|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151666|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151667|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151668|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151669|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151670|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151671|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151672|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151673|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151674|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151675|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151676|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
151677|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151678|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
151679|NCT01358175|E7|Reported Event|Placebo Resp AIN457 150 mg|Placebo Resp AIN457 150 mg
151680|NCT01358175|E6|Reported Event|Placebo Resp AIN457 75 mg|Placebo Resp AIN457 75 mg
151681|NCT01358175|E5|Reported Event|Placebo Non-Resp AIN457 150 mg|Placebo Non-Resp AIN457 150 mg
151682|NCT01358175|E4|Reported Event|Placebo Non-Resp AIN457 75 mg|Placebo Non-Resp AIN457 75 mg
151683|NCT01358175|E3|Reported Event|Placebo|Placebo
151684|NCT01358175|E2|Reported Event|AIN457 10mg/kg -150 mg|AIN457 10mg/kg -150 mg
151685|NCT01358175|E1|Reported Event|AIN457 10mg/kg -75 mg|AIN457 10mg/kg -75 mg
151686|NCT01357980|B5|Baseline|Total|Total of all reporting groups
151687|NCT01357980|B4|Baseline|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151688|NCT01357980|B3|Baseline|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151689|NCT01357980|B2|Baseline|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151690|NCT01357980|B1|Baseline|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151691|NCT01357980|P4|Participant Flow|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151692|NCT01357980|P3|Participant Flow|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151693|NCT01357980|P2|Participant Flow|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151694|NCT01357980|P1|Participant Flow|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151695|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151696|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151697|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151698|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151699|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151700|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151701|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151702|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151703|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151704|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151705|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151706|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151707|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151708|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151709|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151710|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151711|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151712|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151714|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151715|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151716|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151717|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151718|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151719|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151720|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151721|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151722|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151723|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151724|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151725|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151726|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151727|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151728|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151729|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151730|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
151731|NCT01357980|E4|Reported Event|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151732|NCT01357980|E3|Reported Event|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
151733|NCT01357980|E2|Reported Event|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
151734|NCT01357980|E1|Reported Event|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
151735|NCT01357889|B3|Baseline|Total|Total of all reporting groups
151736|NCT01357889|B2|Baseline|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151737|NCT01357889|B1|Baseline|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151738|NCT01357889|P2|Participant Flow|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151739|NCT01357889|P1|Participant Flow|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151740|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151741|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151973|NCT01357239|E4|Reported Event|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151742|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151743|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151744|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151745|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151746|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151747|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151748|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151749|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151750|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151751|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151974|NCT01357239|E3|Reported Event|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151752|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151753|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151754|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151755|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151756|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151757|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151758|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151759|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151760|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151761|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151975|NCT01357239|E2|Reported Event|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151762|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151763|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151764|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151765|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151766|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151767|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151768|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151769|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151770|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151771|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151772|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151773|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151774|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151775|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151776|NCT01357889|E2|Reported Event|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151810|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151811|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151777|NCT01357889|E1|Reported Event|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
151778|NCT01357850|B5|Baseline|Total|Total of all reporting groups
151779|NCT01357850|B4|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151780|NCT01357850|B3|Baseline|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151781|NCT01357850|B2|Baseline|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151782|NCT01357850|B1|Baseline|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151783|NCT01357850|P4|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151784|NCT01357850|P3|Participant Flow|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151785|NCT01357850|P2|Participant Flow|Albiglutide 3.75 mg|Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151786|NCT01357850|P1|Participant Flow|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151787|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151788|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151789|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151790|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151791|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151792|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151793|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151794|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151795|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151796|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151797|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151798|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151799|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151800|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151801|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151802|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151803|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151804|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151805|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151806|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151807|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151808|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151809|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151812|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151813|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151814|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151815|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151816|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151817|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151818|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151819|NCT01357850|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151820|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151821|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151822|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151823|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151824|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151825|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151826|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151827|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151828|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151829|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151830|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151831|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151832|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151833|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151834|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151835|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151836|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151837|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151838|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151839|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151840|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151841|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151842|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151843|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151844|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151845|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151846|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151963|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151847|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151848|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151849|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151850|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151851|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151852|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151853|NCT01357850|E4|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151854|NCT01357850|E3|Reported Event|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151855|NCT01357850|E2|Reported Event|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151856|NCT01357850|E1|Reported Event|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
151857|NCT01357720|B3|Baseline|Total|Total of all reporting groups
151858|NCT01357720|B2|Baseline|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151859|NCT01357720|B1|Baseline|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151860|NCT01357720|P2|Participant Flow|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151861|NCT01357720|P1|Participant Flow|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151862|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151863|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151864|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151865|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151866|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151867|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151868|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151869|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151870|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151871|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151872|NCT01357720|E2|Reported Event|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
151873|NCT01357720|E1|Reported Event|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
151874|NCT01357616|B3|Baseline|Total|Total of all reporting groups
151875|NCT01357616|B2|Baseline|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
151876|NCT01357616|B1|Baseline|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151877|NCT01357616|P2|Participant Flow|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
151878|NCT01357616|P1|Participant Flow|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151879|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151880|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151964|NCT01357239|O3|Outcome|Placebo|2 capsules of placebo per intake
151965|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
169274|NCT01290757|E2|Reported Event|Capsugel|Dabigatran 150mg in Capsugel
151881|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151882|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151883|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151884|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151885|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151886|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
151887|NCT01357616|E2|Reported Event|AZOPT + TIMOLOL (Control Group)|"Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution"
151888|NCT01357616|E1|Reported Event|AZARGA (Test Group)|"Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension"
151889|NCT01357551|B3|Baseline|Total|Total of all reporting groups
151890|NCT01357551|B2|Baseline|Usual Care|Participants are randomized to receive usual care for 56 weeks
151891|NCT01357551|B1|Baseline|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
151892|NCT01357551|P2|Participant Flow|Usual Care|Participants receive usual care for 56 weeks
151893|NCT01357551|P1|Participant Flow|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
151894|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
151895|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
151896|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
151897|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
151898|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
151899|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
151900|NCT01357551|O2|Outcome|Usual Care|Participants are randomized to receive usual care for 56 weeks
151901|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
151902|NCT01357551|E2|Reported Event|Usual Care|Participants receive usual care for 56 weeks
151966|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151967|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151968|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151903|NCT01357551|E1|Reported Event|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
151904|NCT01357512|B3|Baseline|Total|Total of all reporting groups
151905|NCT01357512|B2|Baseline|no MRI|No MRI before prostate biopsies
151906|NCT01357512|B1|Baseline|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
151907|NCT01357512|P2|Participant Flow|no MRI|No MRI before prostate biopsies
151908|NCT01357512|P1|Participant Flow|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
151909|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
151910|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
151911|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
151912|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
151913|NCT01357512|E2|Reported Event|no MRI|No MRI before prostate biopsies
151914|NCT01357512|E1|Reported Event|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
151915|NCT01357239|B5|Baseline|Total|Total of all reporting groups
151916|NCT01357239|B4|Baseline|Placebo|2 capsules of placebo per intake
151917|NCT01357239|B3|Baseline|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151918|NCT01357239|B2|Baseline|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151919|NCT01357239|B1|Baseline|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151920|NCT01357239|P4|Participant Flow|Placebo|2 capsules of placebo per intake
151921|NCT01357239|P3|Participant Flow|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151922|NCT01357239|P2|Participant Flow|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151923|NCT01357239|P1|Participant Flow|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151924|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151925|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151926|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151927|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151928|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151929|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151930|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151931|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151932|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151933|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151934|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151935|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151936|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151937|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151938|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151939|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151940|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151941|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151942|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151943|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151944|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151945|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151946|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151947|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151948|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151949|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151950|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151951|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151952|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151953|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151954|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151955|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151956|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151957|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151958|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
151959|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
151960|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
151961|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
151962|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
170803|NCT01286402|B3|Baseline|Total|Total of all reporting groups
151976|NCT01357239|E1|Reported Event|Placebo|2 capsules of placebo per intake
151977|NCT01357148|B1|Baseline|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
151978|NCT01357148|P1|Participant Flow|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
151979|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
151980|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
151981|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
151982|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
151983|NCT01357148|E1|Reported Event|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
151984|NCT01357135|B4|Baseline|Total|Total of all reporting groups
151985|NCT01357135|B3|Baseline|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
151986|NCT01357135|B2|Baseline|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
151987|NCT01357135|B1|Baseline|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
151988|NCT01357135|P3|Participant Flow|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
151989|NCT01357135|P2|Participant Flow|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
151990|NCT01357135|P1|Participant Flow|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
151991|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
151992|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
151993|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
151994|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
151995|NCT01357135|E3|Reported Event|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
151996|NCT01357135|E2|Reported Event|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
151997|NCT01357135|E1|Reported Event|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
151998|NCT01356966|B3|Baseline|Total|Total of all reporting groups
151999|NCT01356966|B2|Baseline|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152000|NCT01356966|B1|Baseline|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152001|NCT01356966|P2|Participant Flow|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152002|NCT01356966|P1|Participant Flow|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152003|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152004|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152005|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152006|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152007|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152008|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152009|NCT01356966|E2|Reported Event|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
152010|NCT01356966|E1|Reported Event|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
152011|NCT01356940|B3|Baseline|Total|Total of all reporting groups
152012|NCT01356940|B2|Baseline|Placebo Followed by Dalfampridine ER 10mg Bid|"• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks~Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks"
152013|NCT01356940|B1|Baseline|Dalfampridine ER 10mg Bid Followed by Placebo|"• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid~Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks"
152014|NCT01356940|P2|Participant Flow|Placebo-dalfampridine ER 10mg Bid|placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
152015|NCT01356940|P1|Participant Flow|Dalfampridine ER 10mg Bid- Placebo|4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
152016|NCT01356940|O2|Outcome|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
152017|NCT01356940|O1|Outcome|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
152018|NCT01356940|E2|Reported Event|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
152019|NCT01356940|E1|Reported Event|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
152020|NCT01356667|B3|Baseline|Total|Total of all reporting groups
152021|NCT01356667|B2|Baseline|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
152022|NCT01356667|B1|Baseline|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
152023|NCT01356667|P2|Participant Flow|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
152024|NCT01356667|P1|Participant Flow|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
152025|NCT01356667|O2|Outcome|DARTNA|"12-week DARTNA program~DARTNA: 3-hour protocol provided 2x/week over 12 weeks"
152026|NCT01356667|O1|Outcome|Treatment-As-Usual|"Substance Abuse treatment typically received~Treatment-As-Usual: Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions."
152027|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
152028|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
152029|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
152030|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
152031|NCT01356667|E2|Reported Event|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
152032|NCT01356667|E1|Reported Event|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
152033|NCT01356602|B4|Baseline|Total|Total of all reporting groups
152034|NCT01356602|B3|Baseline|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152035|NCT01356602|B2|Baseline|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152036|NCT01356602|B1|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152037|NCT01356602|P3|Participant Flow|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152038|NCT01356602|P2|Participant Flow|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152039|NCT01356602|P1|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152040|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152041|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152042|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152043|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152044|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152045|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152046|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152858|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152047|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152048|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152049|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152050|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152051|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152052|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152053|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152054|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152055|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152056|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152057|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152058|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152059|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152060|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152061|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152062|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152063|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152064|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152065|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152066|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152067|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152068|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152069|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152070|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152071|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152072|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152073|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152074|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152075|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152076|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152077|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152078|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152079|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152080|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152081|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152082|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152083|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152084|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152085|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152086|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152087|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152088|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152089|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152090|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152091|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152092|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152093|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152094|NCT01356602|E3|Reported Event|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
152095|NCT01356602|E2|Reported Event|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
152096|NCT01356602|E1|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
152097|NCT01356589|B1|Baseline|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152279|NCT01355484|B2|Baseline|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
152098|NCT01356589|P1|Participant Flow|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152099|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152100|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152101|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152102|NCT01356589|E1|Reported Event|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
152103|NCT01356498|B7|Baseline|Total|Total of all reporting groups
152104|NCT01356498|B6|Baseline|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152105|NCT01356498|B5|Baseline|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152106|NCT01356498|B4|Baseline|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152107|NCT01356498|B3|Baseline|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152108|NCT01356498|B2|Baseline|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152109|NCT01356498|B1|Baseline|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152110|NCT01356498|P6|Participant Flow|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152111|NCT01356498|P5|Participant Flow|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152112|NCT01356498|P4|Participant Flow|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152113|NCT01356498|P3|Participant Flow|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152114|NCT01356498|P2|Participant Flow|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152115|NCT01356498|P1|Participant Flow|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152116|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152117|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152118|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152119|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152120|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152121|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152122|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152123|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152124|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152862|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152125|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152126|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152127|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152128|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
152129|NCT01356498|O5|Outcome|q4 RCT, Non-responder|Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
152130|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
152131|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
152132|NCT01356498|O2|Outcome|q4 RCT Responder|REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
152133|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
152134|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152135|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152136|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152137|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152138|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152139|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152140|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152141|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152142|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152143|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152144|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152145|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152146|NCT01356498|E6|Reported Event|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152147|NCT01356498|E5|Reported Event|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152148|NCT01356498|E4|Reported Event|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152149|NCT01356498|E3|Reported Event|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
152150|NCT01356498|E2|Reported Event|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
152151|NCT01356498|E1|Reported Event|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
152152|NCT01356407|B3|Baseline|Total|Total of all reporting groups
152153|NCT01356407|B2|Baseline|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152154|NCT01356407|B1|Baseline|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152155|NCT01356407|P2|Participant Flow|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152156|NCT01356407|P1|Participant Flow|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152157|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152414|NCT01354223|B2|Baseline|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152158|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152159|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152160|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152161|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152162|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152163|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152164|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152165|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152166|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152167|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152168|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152169|NCT01356407|E2|Reported Event|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
152170|NCT01356407|E1|Reported Event|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
152171|NCT01356147|B3|Baseline|Total|Total of all reporting groups
152172|NCT01356147|B2|Baseline|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
152173|NCT01356147|B1|Baseline|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
152174|NCT01356147|P2|Participant Flow|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
152175|NCT01356147|P1|Participant Flow|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
152176|NCT01356147|O2|Outcome|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
152177|NCT01356147|O1|Outcome|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
152178|NCT01356147|E2|Reported Event|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
152179|NCT01356147|E1|Reported Event|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
152180|NCT01355978|B1|Baseline|Noninvasive Open Ventilation System|Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
152181|NCT01355978|P1|Participant Flow|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
152182|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
152183|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
152184|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
152185|NCT01355978|E1|Reported Event|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
152186|NCT01355679|B1|Baseline|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
152206|NCT01355588|B3|Baseline|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152280|NCT01355484|B1|Baseline|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
152187|NCT01355679|P1|Participant Flow|Guided Therapy|"A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).~Guided Therapy: A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be"
152188|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
152189|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
152190|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
152191|NCT01355679|O1|Outcome|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
152192|NCT01355679|E1|Reported Event|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
152193|NCT01355627|B3|Baseline|Total|Total of all reporting groups
152194|NCT01355627|B2|Baseline|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
152195|NCT01355627|B1|Baseline|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
152196|NCT01355627|P2|Participant Flow|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
152197|NCT01355627|P1|Participant Flow|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
152198|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
152199|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
152200|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
152201|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
152202|NCT01355627|E2|Reported Event|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
152203|NCT01355627|E1|Reported Event|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
152204|NCT01355588|B5|Baseline|Total|Total of all reporting groups
152205|NCT01355588|B4|Baseline|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152239|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
152207|NCT01355588|B2|Baseline|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152208|NCT01355588|B1|Baseline|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152209|NCT01355588|P4|Participant Flow|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152210|NCT01355588|P3|Participant Flow|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152211|NCT01355588|P2|Participant Flow|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152212|NCT01355588|P1|Participant Flow|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152213|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152214|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152215|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152216|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152217|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152218|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152219|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152220|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152221|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152222|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152223|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152224|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152225|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152226|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152227|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152228|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152229|NCT01355588|E4|Reported Event|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
152230|NCT01355588|E3|Reported Event|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
152231|NCT01355588|E2|Reported Event|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
152232|NCT01355588|E1|Reported Event|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
152233|NCT01355523|B3|Baseline|Total|Total of all reporting groups
152234|NCT01355523|B2|Baseline|Placebo|6 mg oral placebo daily
152235|NCT01355523|B1|Baseline|Melatonin|6 mg oral melatonin daily
152236|NCT01355523|P2|Participant Flow|Placebo|6 mg oral placebo daily
152237|NCT01355523|P1|Participant Flow|Melatonin|6 mg oral melatonin daily
152238|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
152281|NCT01355484|P2|Participant Flow|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
152282|NCT01355484|P1|Participant Flow|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
152283|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
152284|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
152285|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
152286|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
152287|NCT01355484|E2|Reported Event|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
152288|NCT01355484|E1|Reported Event|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
152289|NCT01355471|B3|Baseline|Total|Total of all reporting groups
152290|NCT01355471|B2|Baseline|Placebo|
152291|NCT01355471|B1|Baseline|CD07805/47 Gel|
152292|NCT01355471|P2|Participant Flow|Placebo|
152293|NCT01355471|P1|Participant Flow|CD07805/47 Gel|
152294|NCT01355471|O2|Outcome|Placebo|
152295|NCT01355471|O1|Outcome|CD07805/47 Gel|
152296|NCT01355471|E2|Reported Event|Placebo|
152297|NCT01355471|E1|Reported Event|CD07805/47 Gel|
152298|NCT01355458|B3|Baseline|Total|Total of all reporting groups
152299|NCT01355458|B2|Baseline|Placebo|
152300|NCT01355458|B1|Baseline|CD07805/47 Gel|
152301|NCT01355458|P2|Participant Flow|Placebo|
152302|NCT01355458|P1|Participant Flow|CD07805/47 Gel|
152303|NCT01355458|O2|Outcome|Placebo|
152304|NCT01355458|O1|Outcome|CD07805/47 Gel|
152305|NCT01355458|E2|Reported Event|Placebo|
152306|NCT01355458|E1|Reported Event|CD07805/47 Gel|
152307|NCT01355419|B1|Baseline|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
152308|NCT01355419|P1|Participant Flow|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
152309|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
152310|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
152311|NCT01355419|E1|Reported Event|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
152312|NCT01355081|B4|Baseline|Total|Total of all reporting groups
152313|NCT01355081|B3|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152314|NCT01355081|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152315|NCT01355081|B1|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152316|NCT01355081|P3|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152317|NCT01355081|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152318|NCT01355081|P1|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152319|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152320|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152321|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152322|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152323|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152324|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152325|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152326|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152327|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152328|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152329|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152330|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152331|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152332|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152333|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152334|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152335|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152336|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152337|NCT01355081|E3|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
152338|NCT01355081|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
152339|NCT01355081|E1|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
152340|NCT01355068|B1|Baseline|Entire Study Population|Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
152341|NCT01355068|P2|Participant Flow|Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
152342|NCT01355068|P1|Participant Flow|Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
152343|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152344|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152345|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152346|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152347|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152348|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152349|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152350|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152351|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152352|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152353|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152354|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152355|NCT01355068|E2|Reported Event|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
152356|NCT01355068|E1|Reported Event|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
152357|NCT01354990|B1|Baseline|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152358|NCT01354990|P1|Participant Flow|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152359|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152360|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152361|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152362|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152363|NCT01354990|E1|Reported Event|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
152364|NCT01354938|B1|Baseline|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
152365|NCT01354938|P1|Participant Flow|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
152366|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
152367|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
152368|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
152369|NCT01354938|E1|Reported Event|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
153082|NCT01352416|B5|Baseline|Total|Total of all reporting groups
152370|NCT01354899|B1|Baseline|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
152371|NCT01354899|P1|Participant Flow|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
152372|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
152373|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
152374|NCT01354899|E1|Reported Event|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
152375|NCT01354652|B4|Baseline|Total|Total of all reporting groups
152376|NCT01354652|B3|Baseline|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
152377|NCT01354652|B2|Baseline|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152378|NCT01354652|B1|Baseline|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152379|NCT01354652|P3|Participant Flow|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
152380|NCT01354652|P2|Participant Flow|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152381|NCT01354652|P1|Participant Flow|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152382|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
152412|NCT01354431|E1|Reported Event|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
152413|NCT01354223|B3|Baseline|Total|Total of all reporting groups
153244|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
152383|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152384|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152385|NCT01354652|E3|Reported Event|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
152386|NCT01354652|E2|Reported Event|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152387|NCT01354652|E1|Reported Event|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
152388|NCT01354431|B4|Baseline|Total|Total of all reporting groups
152389|NCT01354431|B3|Baseline|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152390|NCT01354431|B2|Baseline|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152391|NCT01354431|B1|Baseline|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
152392|NCT01354431|P3|Participant Flow|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
152393|NCT01354431|P2|Participant Flow|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
152394|NCT01354431|P1|Participant Flow|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
152395|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152396|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152397|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152398|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152399|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152400|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152401|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152402|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152403|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152404|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152405|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152406|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
152407|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
152408|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
152409|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until progressive disease (PD), toxicity or discontinued for other reasons.
152410|NCT01354431|E3|Reported Event|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
152411|NCT01354431|E2|Reported Event|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
171014|NCT01285635|B4|Baseline|Total|Total of all reporting groups
152415|NCT01354223|B1|Baseline|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152416|NCT01354223|P2|Participant Flow|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152417|NCT01354223|P1|Participant Flow|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152418|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152419|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152420|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152421|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152422|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152423|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152424|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152425|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152426|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152427|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152428|NCT01354223|E2|Reported Event|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
152429|NCT01354223|E1|Reported Event|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
152430|NCT01354145|B3|Baseline|Total|Total of all reporting groups
152431|NCT01354145|B2|Baseline|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152432|NCT01354145|B1|Baseline|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152433|NCT01354145|P2|Participant Flow|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152434|NCT01354145|P1|Participant Flow|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152435|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152436|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152437|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152438|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152439|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152440|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152441|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152442|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152443|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152444|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152445|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152446|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152447|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152448|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152449|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152450|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152451|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152452|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152453|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152454|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152455|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152456|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152457|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152458|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152459|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152460|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152461|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152462|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152463|NCT01354145|E2|Reported Event|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
152464|NCT01354145|E1|Reported Event|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
152465|NCT01354106|B1|Baseline|Infant|Investigational adhesive tape control paper tape
152466|NCT01354106|P1|Participant Flow|Adhesive Medical Tape|"Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1 x 1.5 sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1 x 1.5 sample, applied one ime, worn 24 hours)."
152467|NCT01354106|O2|Outcome|3M Micropore Medical Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
152468|NCT01354106|O1|Outcome|3M Kind Removal Silicone Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
152469|NCT01354106|E2|Reported Event|Control Paper Tape|
152470|NCT01354106|E1|Reported Event|Investigational Adhesive Tape|
152471|NCT01354028|B1|Baseline|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
152472|NCT01354028|P2|Participant Flow|No Massage Therapy First Day, Massage Therapy Second Day|"Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.~Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours."
152473|NCT01354028|P1|Participant Flow|Massage Therapy First Day, no Massage Therapy Second Day|"Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.~Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours"
152474|NCT01354028|O2|Outcome|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
152475|NCT01354028|O1|Outcome|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
152476|NCT01354028|O2|Outcome|Heart Rate Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
152477|NCT01354028|O1|Outcome|Heart Rate During Massage|Heart rate during massage therapy
152478|NCT01354028|O2|Outcome|Oxygen Saturation Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
152479|NCT01354028|O1|Outcome|Oxygen Saturation During Massage|Oxygen saturation during massage therapy
152480|NCT01354028|O2|Outcome|Sleep Efficiency With no Massage Therapy|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
152481|NCT01354028|O1|Outcome|Sleep Efficiency With Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
152539|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152859|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152482|NCT01354028|E2|Reported Event|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
152483|NCT01354028|E1|Reported Event|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
152484|NCT01354015|B3|Baseline|Total|Total of all reporting groups
152485|NCT01354015|B2|Baseline|Usual Care|Usual Care
152486|NCT01354015|B1|Baseline|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
152487|NCT01354015|P2|Participant Flow|Usual Care|Usual Care
152488|NCT01354015|P1|Participant Flow|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
152489|NCT01354015|O2|Outcome|Usual Care|Usual Care
152490|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
152491|NCT01354015|O2|Outcome|Usual Care|Usual Care
152492|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
152493|NCT01354015|E2|Reported Event|Usual Care|Usual Care
152494|NCT01354015|E1|Reported Event|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
152495|NCT01353976|B3|Baseline|Total|Total of all reporting groups
152496|NCT01353976|B2|Baseline|Vehicle Foam|Placebo medication
152497|NCT01353976|B1|Baseline|Econazole Nitrate Foam 1%|Study medication
152498|NCT01353976|P2|Participant Flow|Vehicle Foam|Placebo medication
152499|NCT01353976|P1|Participant Flow|Econazole Nitrate Foam 1%|Study medication
152500|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
152501|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
152502|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
152503|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
152504|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
152505|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
152506|NCT01353976|E2|Reported Event|Vehicle Foam|Placebo medication
152507|NCT01353976|E1|Reported Event|Econazole Nitrate Foam 1%|Study medication
152508|NCT01353963|B1|Baseline|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152509|NCT01353963|P1|Participant Flow|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152510|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152511|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152512|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152513|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152514|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152537|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152515|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152516|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152517|NCT01353963|E1|Reported Event|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
152518|NCT01353911|B9|Baseline|Total|Total of all reporting groups
152519|NCT01353911|B8|Baseline|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152520|NCT01353911|B7|Baseline|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152521|NCT01353911|B6|Baseline|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152522|NCT01353911|B5|Baseline|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152523|NCT01353911|B4|Baseline|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152524|NCT01353911|B3|Baseline|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152525|NCT01353911|B2|Baseline|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152526|NCT01353911|B1|Baseline|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152527|NCT01353911|P8|Participant Flow|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152528|NCT01353911|P7|Participant Flow|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152529|NCT01353911|P6|Participant Flow|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152530|NCT01353911|P5|Participant Flow|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152531|NCT01353911|P4|Participant Flow|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152532|NCT01353911|P3|Participant Flow|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152533|NCT01353911|P2|Participant Flow|Grazoprevir 100 mg|TN non-cirrhotic (NC) participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152534|NCT01353911|P1|Participant Flow|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152535|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152536|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152538|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152540|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152541|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152542|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152543|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152544|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152545|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152546|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152547|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152548|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152549|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152550|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152551|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152552|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152553|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152554|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152555|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152556|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152557|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152558|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152559|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152560|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152561|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152562|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152563|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152564|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152565|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152860|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152566|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152567|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152568|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152569|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152570|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152571|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152572|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152573|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152574|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152575|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152576|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152577|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152578|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152579|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152580|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152581|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152582|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152583|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152584|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152585|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152586|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152587|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152588|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152589|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152590|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152591|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152592|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152593|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152594|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152595|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152596|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152597|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152598|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152599|NCT01353911|E8|Reported Event|Non-cirr: Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
152600|NCT01353911|E7|Reported Event|Non-cirr: Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152601|NCT01353911|E6|Reported Event|Non-cirr: Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152602|NCT01353911|E5|Reported Event|Non-cirr: Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152603|NCT01353911|E4|Reported Event|Non-cirr: Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152604|NCT01353911|E3|Reported Event|Non-cirr: Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152605|NCT01353911|E2|Reported Event|Non-cirr: Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152606|NCT01353911|E1|Reported Event|Cirr: OL Grazoprevir 100 mg|TN cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
152607|NCT01353898|B7|Baseline|Total|Total of all reporting groups
152608|NCT01353898|B6|Baseline|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152609|NCT01353898|B5|Baseline|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152610|NCT01353898|B4|Baseline|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152611|NCT01353898|B3|Baseline|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152612|NCT01353898|B2|Baseline|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152613|NCT01353898|B1|Baseline|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152614|NCT01353898|P6|Participant Flow|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152615|NCT01353898|P5|Participant Flow|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152616|NCT01353898|P4|Participant Flow|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152617|NCT01353898|P3|Participant Flow|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152618|NCT01353898|P2|Participant Flow|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152619|NCT01353898|P1|Participant Flow|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152620|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152621|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152622|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152623|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152624|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152625|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152626|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152627|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152628|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152629|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152630|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152631|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152632|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152633|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152634|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152635|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152636|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152637|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152638|NCT01353898|E6|Reported Event|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
152639|NCT01353898|E5|Reported Event|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152640|NCT01353898|E4|Reported Event|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
152641|NCT01353898|E3|Reported Event|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152642|NCT01353898|E2|Reported Event|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152643|NCT01353898|E1|Reported Event|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
152644|NCT01353859|B1|Baseline|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152645|NCT01353859|P1|Participant Flow|Tocilizumab + Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152646|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152647|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152648|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152649|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
172827|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
152650|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152651|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152652|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152653|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152654|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152655|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152656|NCT01353859|E1|Reported Event|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
152657|NCT01353664|B1|Baseline|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
152658|NCT01353664|P1|Participant Flow|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
152659|NCT01353664|O1|Outcome|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
152660|NCT01353664|E1|Reported Event|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
152661|NCT01353586|B3|Baseline|Total|Total of all reporting groups
152662|NCT01353586|B2|Baseline|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
152663|NCT01353586|B1|Baseline|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
152684|NCT01353508|P3|Participant Flow|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152861|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152664|NCT01353586|P2|Participant Flow|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
152665|NCT01353586|P1|Participant Flow|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
152666|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are related for transparency; but cannot be compared statistically against the data from the Main Study group."
152667|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
152668|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
152669|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
152670|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152671|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152672|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152673|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152674|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152675|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
152676|NCT01353586|E2|Reported Event|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
152677|NCT01353586|E1|Reported Event|nMARQ™ System (Main Study)|nMARQ™ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF).
152678|NCT01353508|B5|Baseline|Total|Total of all reporting groups
152679|NCT01353508|B4|Baseline|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152680|NCT01353508|B3|Baseline|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152681|NCT01353508|B2|Baseline|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152682|NCT01353508|B1|Baseline|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152683|NCT01353508|P4|Participant Flow|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152853|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152854|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152685|NCT01353508|P2|Participant Flow|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152686|NCT01353508|P1|Participant Flow|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152687|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152688|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152689|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152690|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152691|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152692|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152693|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152694|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152695|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152696|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152697|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152698|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152699|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152700|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152701|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152702|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152703|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152704|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152705|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152706|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152707|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152708|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152855|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152709|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152710|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152711|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152712|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152713|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152714|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152715|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152716|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152717|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152718|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152719|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152720|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152721|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152722|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152723|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152724|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152725|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152726|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152727|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152728|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152729|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152730|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152731|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152732|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152856|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
173053|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
152733|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152734|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152735|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152736|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152737|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152738|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152739|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152740|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152741|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152742|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152743|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152744|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152745|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152746|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152747|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152748|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152749|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152750|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152751|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152752|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152753|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152754|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152755|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152756|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152857|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152757|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152758|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152759|NCT01353508|E4|Reported Event|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
152760|NCT01353508|E3|Reported Event|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
152761|NCT01353508|E2|Reported Event|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
152762|NCT01353508|E1|Reported Event|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
152763|NCT01353274|B1|Baseline|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152764|NCT01353274|P1|Participant Flow|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152765|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152766|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152767|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152768|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152769|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152770|NCT01353274|E1|Reported Event|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
152771|NCT01353144|B3|Baseline|Total|Total of all reporting groups
152772|NCT01353144|B2|Baseline|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
152773|NCT01353144|B1|Baseline|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
152774|NCT01353144|P2|Participant Flow|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
152775|NCT01353144|P1|Participant Flow|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
152776|NCT01353144|O2|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
152777|NCT01353144|O1|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
152778|NCT01353144|O2|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
152779|NCT01353144|O1|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
152780|NCT01353144|E2|Reported Event|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
152781|NCT01353144|E1|Reported Event|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
152782|NCT01353079|B3|Baseline|Total|Total of all reporting groups
152783|NCT01353079|B2|Baseline|Glycero-COCAs|Placebo: Glycero-COCAS sublingual
152784|NCT01353079|B1|Baseline|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152785|NCT01353079|P2|Participant Flow|Glycero-COCAs|Placebo-Glycero-COCAs sublingual
152786|NCT01353079|P1|Participant Flow|Short Ragweed Pollen Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152787|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
152788|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152789|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
152790|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152791|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
152792|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152793|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
152794|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
152795|NCT01353079|E2|Reported Event|Glycero-Cocas|placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
152796|NCT01353079|E1|Reported Event|Ragweed Allergenic Extract|"allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual"
152797|NCT01352845|B3|Baseline|Total|Total of all reporting groups
152798|NCT01352845|B2|Baseline|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152799|NCT01352845|B1|Baseline|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152800|NCT01352845|P2|Participant Flow|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152801|NCT01352845|P1|Participant Flow|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152802|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152803|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152804|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152805|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152806|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152807|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152808|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152809|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152810|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152811|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152812|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152813|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152814|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152815|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152816|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152817|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152818|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152819|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152820|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152821|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152822|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152823|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152824|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152825|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152826|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152827|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152828|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152829|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152830|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152831|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152832|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152833|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152834|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152835|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152836|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152837|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152838|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152839|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152840|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152841|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152842|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152843|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152844|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152845|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152846|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152847|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152848|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152849|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152850|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152851|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152852|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152863|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152864|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152865|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152866|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152867|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152868|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152869|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152870|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152871|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152872|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152873|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152874|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152875|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152876|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152877|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152878|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152879|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152880|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152881|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152882|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152883|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152884|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152885|NCT01352845|E2|Reported Event|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
152886|NCT01352845|E1|Reported Event|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
152887|NCT01352793|B3|Baseline|Total|Total of all reporting groups
152888|NCT01352793|B2|Baseline|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152889|NCT01352793|B1|Baseline|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152890|NCT01352793|P2|Participant Flow|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152891|NCT01352793|P1|Participant Flow|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152892|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152893|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152894|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152895|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152896|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152897|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152898|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152899|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152900|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152901|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152902|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152903|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152904|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152905|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152906|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152907|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152908|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
153108|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
152909|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152910|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152911|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152912|NCT01352793|E2|Reported Event|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
152913|NCT01352793|E1|Reported Event|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
152914|NCT01352741|B1|Baseline|All Trial Participants|All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
152915|NCT01352741|P2|Participant Flow|Tapentadol Prolonged Release and Pregabalin|At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
152916|NCT01352741|P1|Participant Flow|Tapentadol Prolonged Release|All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
152917|NCT01352741|O2|Outcome|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
152918|NCT01352741|O1|Outcome|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
152919|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
152920|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152921|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152922|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152923|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152924|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152925|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152926|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152927|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152928|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
152929|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
152930|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
152931|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152932|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152933|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152934|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152935|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
152936|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
152937|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
153421|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
152938|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152939|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152940|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152941|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152942|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
152943|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
152944|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
152945|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152946|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152947|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152948|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152949|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
152950|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
152951|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
152952|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152953|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152954|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152955|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152956|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152957|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152958|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152959|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152960|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152961|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152962|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152963|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152964|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152965|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152966|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152967|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152968|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152969|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152970|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152971|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152972|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152973|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152974|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152975|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152976|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152977|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152978|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152979|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152980|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
152981|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152982|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152983|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152984|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152985|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
152986|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152987|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152988|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152989|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152990|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
152991|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152992|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
153422|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
152993|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
152994|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
152995|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
152996|NCT01352741|O2|Outcome|Tapentadol Prolonged Release After Tapentadol and Pregabalin|Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
152997|NCT01352741|O1|Outcome|Tapentadol Prolonged Release After Tapentadol|Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
152998|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
152999|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
153000|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
153001|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
153002|NCT01352741|E5|Reported Event|Open-Label Tapentadol Continuation Period|Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
153003|NCT01352741|E4|Reported Event|Open-Label Tapentadol Pick-Up Arm|Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
153004|NCT01352741|E3|Reported Event|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
153005|NCT01352741|E2|Reported Event|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
153006|NCT01352741|E1|Reported Event|Open-Label Tapentadol Titration Period|"During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.~Titration dose steps on a weekly basis:~First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.~The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.~The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit."
153007|NCT01352715|B3|Baseline|Total|Total of all reporting groups
153008|NCT01352715|B2|Baseline|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153009|NCT01352715|B1|Baseline|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153010|NCT01352715|P2|Participant Flow|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153011|NCT01352715|P1|Participant Flow|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153109|NCT01351506|E2|Reported Event|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
153110|NCT01351506|E1|Reported Event|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
153012|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153013|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153014|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153015|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153016|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153017|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153018|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153019|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153020|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153021|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153022|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153023|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153236|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153237|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153024|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153025|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153026|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153027|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153028|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153029|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
153030|NCT01352715|E2|Reported Event|LPV/r + NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily."
153031|NCT01352715|E1|Reported Event|LPV/r + RAL|Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.
153032|NCT01352585|B1|Baseline|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153033|NCT01352585|P1|Participant Flow|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153034|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153035|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153036|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153037|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153038|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153039|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153040|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153041|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153042|NCT01352585|E1|Reported Event|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
153043|NCT01352507|B3|Baseline|Total|Total of all reporting groups
153044|NCT01352507|B2|Baseline|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
153238|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153239|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153045|NCT01352507|B1|Baseline|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
153046|NCT01352507|P2|Participant Flow|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
153047|NCT01352507|P1|Participant Flow|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
153048|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153049|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153050|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153051|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153052|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153053|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153054|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153055|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153056|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153057|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153058|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153059|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153060|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153061|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153062|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
153063|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
153064|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153065|NCT01352507|O1|Outcome|Tadalafil|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153066|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153067|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153068|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153069|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153070|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
153071|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
153072|NCT01352507|O1|Outcome|All Randomized Participants|Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
153073|NCT01352507|E4|Reported Event|Sildenafil (Extension Phase)|Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
153074|NCT01352507|E3|Reported Event|Tadalafil (Extension Phase)|Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
153075|NCT01352507|E2|Reported Event|Sildenafil (Treatment Periods)|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153076|NCT01352507|E1|Reported Event|Tadalafil (Treatment Periods)|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
153077|NCT01352442|B1|Baseline|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
153078|NCT01352442|P1|Participant Flow|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
153079|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
153080|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
153081|NCT01352442|E1|Reported Event|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
153083|NCT01352416|B4|Baseline|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153084|NCT01352416|B3|Baseline|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153085|NCT01352416|B2|Baseline|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153086|NCT01352416|B1|Baseline|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153087|NCT01352416|P4|Participant Flow|Sugar Pills and Patients Having Non CABG Heart Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
153088|NCT01352416|P3|Participant Flow|Ranolazine With Patients Having Non CABG Heart Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153089|NCT01352416|P2|Participant Flow|Sugar Pill and Patients Having CABG Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
153090|NCT01352416|P1|Participant Flow|Ranolazine and Patients Having CABG Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153091|NCT01352416|O4|Outcome|Placebo Without CABG|Placebo 2 pills twice daily without CABG
153092|NCT01352416|O3|Outcome|Ranolazine Without CABG|Ranolazine 500 mg 2 pills twice daily without CABG
153093|NCT01352416|O2|Outcome|Placebo With CABG|Placebo 2 pills twice daily with CABG
153094|NCT01352416|O1|Outcome|Ranolazine With Coronary Artery Bypass Graft (CABG)|Ranolazine 500 mg 2 pills twice a day with Coronary Artery Bypass Graft (CABG)
153095|NCT01352416|E4|Reported Event|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153096|NCT01352416|E3|Reported Event|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153097|NCT01352416|E2|Reported Event|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153098|NCT01352416|E1|Reported Event|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
153099|NCT01351506|B3|Baseline|Total|Total of all reporting groups
153100|NCT01351506|B2|Baseline|ICU Non Survivors|Patients who non survivors from ICU discharge status
153101|NCT01351506|B1|Baseline|ICU Survivors|Patients who survivors from ICU discharge status
153102|NCT01351506|P1|Participant Flow|Cohort Patient|A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
153103|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
153104|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
153105|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
153106|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
153107|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
153111|NCT01351337|B1|Baseline|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153112|NCT01351337|P1|Participant Flow|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153113|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153114|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153115|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153116|NCT01351337|E1|Reported Event|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
153117|NCT01351090|B4|Baseline|Total|Total of all reporting groups
153118|NCT01351090|B3|Baseline|Placebo Vehicle IN|Intranasal placebo
153119|NCT01351090|B2|Baseline|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153120|NCT01351090|B1|Baseline|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153121|NCT01351090|P3|Participant Flow|Placebo Vehicle IN|Intranasal placebo
153122|NCT01351090|P2|Participant Flow|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153123|NCT01351090|P1|Participant Flow|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153124|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
153125|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153126|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153127|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
153128|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153129|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153130|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
153131|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153132|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153133|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
153134|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153135|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153136|NCT01351090|E3|Reported Event|Placebo Vehicle IN|Intranasal placebo
153137|NCT01351090|E2|Reported Event|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
153138|NCT01351090|E1|Reported Event|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
153139|NCT01351064|B3|Baseline|Total|Total of all reporting groups
153140|NCT01351064|B2|Baseline|CHICA ADHD Control|This arm received CHICA without the ADHD module
153141|NCT01351064|B1|Baseline|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
153142|NCT01351064|P2|Participant Flow|CHICA ADHD Control|This arm received CHICA without the ADHD module
153143|NCT01351064|P1|Participant Flow|CHICA ADHD Module|"This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
153144|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
153145|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
153146|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
153147|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
153148|NCT01351064|E2|Reported Event|CHICA ADHD Control|This arm received CHICA without the ADHD module
153149|NCT01351064|E1|Reported Event|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
153150|NCT01351025|B3|Baseline|Total|Total of all reporting groups
153151|NCT01351025|B2|Baseline|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153240|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153241|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
174950|NCT01272583|O2|Outcome|Sitagliptin Treatment|
153152|NCT01351025|B1|Baseline|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153153|NCT01351025|P2|Participant Flow|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153154|NCT01351025|P1|Participant Flow|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153155|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153156|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
153157|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
153158|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153159|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153160|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153161|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153181|NCT01351025|E2|Reported Event|Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
153242|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
174951|NCT01272583|O1|Outcome|Baseline|
153162|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153163|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153164|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153165|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153166|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153167|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153168|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153169|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153170|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153171|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153172|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153173|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153174|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153175|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153176|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153177|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
153178|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
153179|NCT01351025|E4|Reported Event|Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)|At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
153180|NCT01351025|E3|Reported Event|Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
153243|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153182|NCT01351025|E1|Reported Event|Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
153183|NCT01350999|B4|Baseline|Total|Total of all reporting groups
153184|NCT01350999|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153185|NCT01350999|B2|Baseline|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153186|NCT01350999|B1|Baseline|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153187|NCT01350999|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153188|NCT01350999|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153189|NCT01350999|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153190|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153191|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153192|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153193|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153194|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153195|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153196|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153197|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153198|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153199|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153200|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153201|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153202|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153203|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153204|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153205|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153206|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153207|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153208|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153209|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153210|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153211|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153212|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153213|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153214|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153215|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153216|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153217|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153218|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153219|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153220|NCT01350999|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
153221|NCT01350999|E2|Reported Event|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
153222|NCT01350999|E1|Reported Event|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
153223|NCT01350973|B4|Baseline|Total|Total of all reporting groups
153224|NCT01350973|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153225|NCT01350973|B2|Baseline|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153226|NCT01350973|B1|Baseline|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153227|NCT01350973|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153228|NCT01350973|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153229|NCT01350973|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153230|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153231|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153232|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153233|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153234|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153235|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
174952|NCT01272583|O3|Outcome|Placebo|
153245|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153246|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153247|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153248|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153249|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153250|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153251|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153252|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153253|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153254|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153255|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153256|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153257|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153258|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153259|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153260|NCT01350973|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
153261|NCT01350973|E2|Reported Event|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
153262|NCT01350973|E1|Reported Event|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
153263|NCT01350947|B1|Baseline|All Patients|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
153264|NCT01350947|P1|Participant Flow|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
153265|NCT01350947|O1|Outcome|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
153266|NCT01350947|E1|Reported Event|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
153267|NCT01350934|B3|Baseline|Total|Total of all reporting groups
153268|NCT01350934|B2|Baseline|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153269|NCT01350934|B1|Baseline|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153270|NCT01350934|P2|Participant Flow|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153271|NCT01350934|P1|Participant Flow|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153272|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153273|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153274|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153275|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153276|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153277|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153278|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153279|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153280|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153281|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153282|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153283|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153284|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153285|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153286|NCT01350934|E2|Reported Event|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
153287|NCT01350934|E1|Reported Event|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
153288|NCT01350804|B5|Baseline|Total|Total of all reporting groups
153289|NCT01350804|B4|Baseline|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153290|NCT01350804|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153291|NCT01350804|B2|Baseline|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153292|NCT01350804|B1|Baseline|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153293|NCT01350804|P4|Participant Flow|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153294|NCT01350804|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153295|NCT01350804|P2|Participant Flow|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153296|NCT01350804|P1|Participant Flow|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153297|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
153298|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153299|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
153300|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
153301|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153302|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
153303|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
153304|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153305|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153306|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153307|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153308|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
153309|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153310|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
153311|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
153312|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153313|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
153314|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
153315|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
174953|NCT01272583|O2|Outcome|Sitagliptin Treatment|
153316|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153317|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153318|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153319|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
153320|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153321|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
153322|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
153323|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153324|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
153325|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
153326|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153327|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153328|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153329|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153330|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153331|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153332|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153333|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153334|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
153335|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153336|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
153337|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
153338|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153339|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
153340|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
153341|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153342|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153343|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153344|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153345|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153346|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153347|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153348|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153349|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
153350|NCT01350804|O10|Outcome|Abatacept Non-respnders - AIN457 75mg|Participants switched from abatacept to AIN457 75 mg starting at week 24.
153351|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
153352|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
153353|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
153354|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150 mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
153355|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75 mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
153356|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153357|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153358|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153359|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153360|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153361|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153362|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153363|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153364|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153365|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153366|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153367|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153368|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153369|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153370|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153371|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153372|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153373|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153374|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153375|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153376|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153377|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153378|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
153379|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
153380|NCT01350804|E4|Reported Event|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
153381|NCT01350804|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
153382|NCT01350804|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
153383|NCT01350804|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
153423|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153424|NCT01350388|E2|Reported Event|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
174954|NCT01272583|O1|Outcome|Baseline|
153384|NCT01350583|B1|Baseline|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153385|NCT01350583|P1|Participant Flow|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153386|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153387|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153388|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153389|NCT01350583|E1|Reported Event|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
153390|NCT01350414|B1|Baseline|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
153391|NCT01350414|P1|Participant Flow|Alair Group|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)~Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System"
153392|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol Number 04-02, NCT00231114).
153393|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153394|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153395|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153396|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153397|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153398|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
153399|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
153400|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153401|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
153402|NCT01350414|E5|Reported Event|Year 5|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not."
153403|NCT01350414|E4|Reported Event|Year 4|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not."
153404|NCT01350414|E3|Reported Event|Year 3|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not."
153405|NCT01350414|E2|Reported Event|Year 2|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not."
153406|NCT01350414|E1|Reported Event|Year 1|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not."
153407|NCT01350388|B3|Baseline|Total|Total of all reporting groups
153408|NCT01350388|B2|Baseline|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153409|NCT01350388|B1|Baseline|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153410|NCT01350388|P2|Participant Flow|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153411|NCT01350388|P1|Participant Flow|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153412|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153413|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153414|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153415|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153416|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153417|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153418|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
153419|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153420|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
174955|NCT01272583|O3|Outcome|Placebo|
153425|NCT01350388|E1|Reported Event|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
153426|NCT01350271|B4|Baseline|Total|Total of all reporting groups
153427|NCT01350271|B3|Baseline|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
153428|NCT01350271|B2|Baseline|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
153429|NCT01350271|B1|Baseline|Placebo|Hookworm positive participants randomized to placebo
153430|NCT01350271|P3|Participant Flow|Mebendazole Polymorph C 500 mg|74 were allocated and 48 were followed up in the post treatment.
153431|NCT01350271|P2|Participant Flow|Mebendazole Polymorph A and C 500 mg|70 were allocated and 53 were followed up in the post treatment.
153432|NCT01350271|P1|Participant Flow|Placebo|70 were allocated to this arm and 49 were followed up in the post treatment.
153433|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
153434|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
153435|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
153436|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
153437|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
153438|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
153439|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
153440|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg
153441|NCT01350271|O1|Outcome|Placebo|Hookworm infected individual randomized to placebo
153442|NCT01350271|E3|Reported Event|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
153443|NCT01350271|E2|Reported Event|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
153444|NCT01350271|E1|Reported Event|Placebo|Hookworm positive participants randomized to placebo
153445|NCT01350258|B1|Baseline|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153446|NCT01350258|P1|Participant Flow|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153447|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153448|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153449|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153450|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153451|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153492|NCT01349933|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
153452|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153453|NCT01350258|E1|Reported Event|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
153454|NCT01350245|B1|Baseline|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
153455|NCT01350245|P1|Participant Flow|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
153456|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
153457|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
153458|NCT01350245|E1|Reported Event|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
153459|NCT01350232|B1|Baseline|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153493|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
153624|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153460|NCT01350232|P1|Participant Flow|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153461|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153462|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153463|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153464|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153465|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153466|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153490|NCT01349959|E1|Reported Event|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153619|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153467|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153468|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153469|NCT01350232|E1|Reported Event|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
153470|NCT01350115|B3|Baseline|Total|Total of all reporting groups
153471|NCT01350115|B2|Baseline|Placebo|Participants received matching placebo.
153472|NCT01350115|B1|Baseline|LDE225|Participants received 400 mg once daily.
153473|NCT01350115|P2|Participant Flow|Placebo|Participants received matching placebo.
153474|NCT01350115|P1|Participant Flow|LDE225|Participants received 400 mg once daily.
153475|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
153476|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
153477|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
153478|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
153479|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
153480|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
153481|NCT01350115|E4|Reported Event|Placebo - Long Term Follow-up|
153482|NCT01350115|E3|Reported Event|LDE225 - Long Term Follow-up|
153483|NCT01350115|E2|Reported Event|Placebo - Core|Participants received matching placebo.
153484|NCT01350115|E1|Reported Event|LDE225 - Core|Participants received 400 mg once daily.
153485|NCT01349959|B1|Baseline|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153486|NCT01349959|P1|Participant Flow|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153487|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153488|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153489|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
153491|NCT01349933|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
153494|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
153495|NCT01349933|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206: Given PO
153496|NCT01349920|B1|Baseline|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153497|NCT01349920|P1|Participant Flow|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153498|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153499|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153500|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153501|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153502|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153503|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153504|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153505|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153506|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153507|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153508|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153509|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153510|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153511|NCT01349920|E3|Reported Event|Post-study|From last dose of study drug, up to 24 days after last dose of infliximab
153512|NCT01349920|E2|Reported Event|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
153513|NCT01349920|E1|Reported Event|Pre-study|From 4 weeks prior to first dose, up to first dose of infliximab
153514|NCT01349907|B3|Baseline|Total|Total of all reporting groups
153515|NCT01349907|B2|Baseline|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153516|NCT01349907|B1|Baseline|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153517|NCT01349907|P2|Participant Flow|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153518|NCT01349907|P1|Participant Flow|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153519|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153520|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153521|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153522|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153523|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153524|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153525|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153526|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153620|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153621|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153527|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153528|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153529|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153530|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153531|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153532|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153533|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153534|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153535|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153536|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153537|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153538|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153539|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153540|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153541|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153542|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153543|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153544|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153545|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153546|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153547|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153548|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153622|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153623|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153549|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153550|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153551|NCT01349907|E2|Reported Event|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153552|NCT01349907|E1|Reported Event|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
153553|NCT01349829|B3|Baseline|Total|Total of all reporting groups
153554|NCT01349829|B2|Baseline|Havrix|
153555|NCT01349829|B1|Baseline|HAVpur|
153556|NCT01349829|P2|Participant Flow|Havrix|
153557|NCT01349829|P1|Participant Flow|HAVpur|
153558|NCT01349829|O2|Outcome|Havrix|
153559|NCT01349829|O1|Outcome|HAVpur|
153560|NCT01349829|O2|Outcome|Havrix|
153561|NCT01349829|O1|Outcome|HAVpur|
153562|NCT01349829|O2|Outcome|Havrix|
153563|NCT01349829|O1|Outcome|HAVpur|
153564|NCT01349829|O2|Outcome|Havrix|
153565|NCT01349829|O1|Outcome|HAVpur|
153566|NCT01349829|O2|Outcome|Havrix|
153567|NCT01349829|O1|Outcome|HAVpur|
153568|NCT01349829|O2|Outcome|Havrix|
153569|NCT01349829|O1|Outcome|HAVpur|
153570|NCT01349829|E4|Reported Event|Havrix - Second Vaccination|
153571|NCT01349829|E3|Reported Event|HAVPur - Second Vaccination|
153572|NCT01349829|E2|Reported Event|Havrix - First Vaccination|
153573|NCT01349829|E1|Reported Event|HAVpur - First Vaccination|
153574|NCT01349803|B5|Baseline|Total|Total of all reporting groups
153575|NCT01349803|B4|Baseline|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153576|NCT01349803|B3|Baseline|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153577|NCT01349803|B2|Baseline|GP MDI (PT001)|GP MDI 36 mcg
153578|NCT01349803|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
153579|NCT01349803|P4|Participant Flow|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153580|NCT01349803|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153581|NCT01349803|P2|Participant Flow|GP MDI (PT001)|GP MDI 36 mcg
153582|NCT01349803|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
153583|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153584|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153585|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
153586|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
153587|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153588|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153589|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153590|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153591|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153592|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153593|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153594|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153595|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153596|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153597|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153598|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153599|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153600|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153601|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153602|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153603|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153604|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153605|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153606|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153607|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153608|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153609|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153610|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153611|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153612|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153613|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153614|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153615|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153616|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153617|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153618|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153625|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153626|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
153627|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153628|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55
153629|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=57 Day 14: N=57
153630|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58
153631|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
153632|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
153633|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
153634|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59
153635|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153636|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153637|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
153638|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
153639|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153640|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153641|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
153642|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
153643|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153644|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153645|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
153646|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
153647|NCT01349803|E4|Reported Event|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
153648|NCT01349803|E3|Reported Event|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
153649|NCT01349803|E2|Reported Event|GP MDI (PT001)|GP MDI 36 mcg
153650|NCT01349803|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
153651|NCT01349595|B3|Baseline|Total|Total of all reporting groups
153652|NCT01349595|B2|Baseline|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
153653|NCT01349595|B1|Baseline|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
153654|NCT01349595|P2|Participant Flow|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
153655|NCT01349595|P1|Participant Flow|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
153656|NCT01349595|O2|Outcome|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
153657|NCT01349595|O1|Outcome|Bortezomib|Bortezomib is a type of targeted chemotherapy
153658|NCT01349595|E2|Reported Event|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
153659|NCT01349595|E1|Reported Event|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
153660|NCT01349465|B3|Baseline|Total|Total of all reporting groups
153661|NCT01349465|B2|Baseline|No SVR at LPVPS|Participants with No sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153662|NCT01349465|B1|Baseline|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153663|NCT01349465|P2|Participant Flow|No SVR at LPVPS|Participants with No sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153664|NCT01349465|P1|Participant Flow|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153665|NCT01349465|O1|Outcome|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153666|NCT01349465|O1|Outcome|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153667|NCT01349465|O2|Outcome|No SVR at LPVPS|Participants with No sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153668|NCT01349465|O1|Outcome|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153669|NCT01349465|O1|Outcome|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153670|NCT01349465|O1|Outcome|No SVR at LPVPS|Participants with No sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153671|NCT01349465|O1|Outcome|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153672|NCT01349465|E3|Reported Event|Total|All Enrolled Subjects
153673|NCT01349465|E2|Reported Event|No SVR at LPVPS|Participants with No sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153674|NCT01349465|E1|Reported Event|SVR at LPVPS|Participants with sustained virologic response (SVR) at last post-therapy visit of the previous study (LPVPS).
153675|NCT01349231|B1|Baseline|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153676|NCT01349231|P1|Participant Flow|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153677|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153678|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153679|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153680|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153681|NCT01349231|E1|Reported Event|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
153682|NCT01349114|B3|Baseline|Total|Total of all reporting groups
153683|NCT01349114|B2|Baseline|Placebo|Sugar pill/placebo
153684|NCT01349114|B1|Baseline|Aliskiren|aliskiren 300 mg daily
153685|NCT01349114|P2|Participant Flow|Sugar Pill/Placebo|Sugar pill/placebo arm
153686|NCT01349114|P1|Participant Flow|Aliskiren|aliskiren 300 mg daily
153687|NCT01349114|O2|Outcome|Placebo|placebo: placebo
153688|NCT01349114|O1|Outcome|Aliskiren|"aliskiren 300 mg daily~aliskiren: aliskiren 300 mg daily"
153689|NCT01349114|O2|Outcome|Placebo|Sugar pill/ placebo
153690|NCT01349114|O1|Outcome|Aliskiren|aliskiren 300 mg daily
153691|NCT01349114|E2|Reported Event|Placebo|Sugar pill/ placebo
153692|NCT01349114|E1|Reported Event|Aliskiren|aliskiren 300 mg daily
153693|NCT01348854|B3|Baseline|Total|Total of all reporting groups
153694|NCT01348854|B2|Baseline|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
153695|NCT01348854|B1|Baseline|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
153696|NCT01348854|P2|Participant Flow|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
153697|NCT01348854|P1|Participant Flow|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
153698|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
153699|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
153700|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
153701|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
153702|NCT01348854|E2|Reported Event|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
153703|NCT01348854|E1|Reported Event|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
153704|NCT01348789|B1|Baseline|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
153705|NCT01348789|P1|Participant Flow|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
153706|NCT01348789|O1|Outcome|Hair Clearance From All Areas|Treatment with Hair2Go (Mē) device
153707|NCT01348789|O6|Outcome|Dark Skin - Treat#3|Self assessment of tolerability for skin photo-type V-VI after treatment#3
153708|NCT01348789|O5|Outcome|Dark Skin - Treat#2|Self assessment of tolerability for skin photo-type V-VI after treatment#2
153709|NCT01348789|O4|Outcome|Dark Skin - Treat#1|Self assessment of tolerability for skin photo-type V-VI after treatment#1
153710|NCT01348789|O3|Outcome|Light Skin - Treat#3|Self assessment of tolerability for skin photo-type I-IV after treatment#3.
153711|NCT01348789|O2|Outcome|Light Skin - Treat#2|Self assessment of tolerability for skin photo-type I-IV after treatment#2.
153712|NCT01348789|O1|Outcome|Light Skin - Treat#1|Self assessment of tolerability for skin photo-type I-IV after treatment#1.
153713|NCT01348789|O1|Outcome|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
153714|NCT01348789|E1|Reported Event|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
153715|NCT01348776|B1|Baseline|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
153716|NCT01348776|P1|Participant Flow|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
153717|NCT01348776|O1|Outcome|Hair2Go (Mē)|Subjects treated with the Hair2Go (Me) Device
153718|NCT01348776|O4|Outcome|Maintenance Treatment #3|Self assessment of tolerability level of procedure during 3rd maintenance treatment
153719|NCT01348776|O3|Outcome|Treatment #7|Self assessment of tolerability level of procedure during 7th treatment
153720|NCT01348776|O2|Outcome|Treatment #3|Self assessment of tolerability level of procedure during 3rd treatment
153721|NCT01348776|O1|Outcome|Treatment #1|Self assessment of tolerability level of procedure during 1st treatment
153722|NCT01348776|O1|Outcome|Anticipated Skin Effects|Anticipated skin effects included mild to moderate sense of warmth, tingling, or itching, and transient erythema and edema.
153723|NCT01348776|O2|Outcome|No Maintenance Side|Hair clearance after 7 weekly treatments without additional maintenance treatments
153724|NCT01348776|O1|Outcome|Maintenance Side|Hair clearance after 7 weekly treatments+2 additional monthly maintenance treatments
153725|NCT01348776|O2|Outcome|Hair2Go (Mē) no Maintenance Side|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
153726|NCT01348776|O1|Outcome|Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
153727|NCT01348776|E1|Reported Event|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
153728|NCT01348607|B4|Baseline|Total|Total of all reporting groups
153729|NCT01348607|B3|Baseline|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
153730|NCT01348607|B2|Baseline|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
153731|NCT01348607|B1|Baseline|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
153732|NCT01348607|P3|Participant Flow|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
153733|NCT01348607|P2|Participant Flow|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
153734|NCT01348607|P1|Participant Flow|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
153735|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
153736|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
153737|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
153738|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
153739|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
153740|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
153741|NCT01348607|E3|Reported Event|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
153742|NCT01348607|E2|Reported Event|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
153743|NCT01348607|E1|Reported Event|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
153744|NCT01348425|B3|Baseline|Total|Total of all reporting groups
153745|NCT01348425|B2|Baseline|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
153746|NCT01348425|B1|Baseline|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
153747|NCT01348425|P2|Participant Flow|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
153748|NCT01348425|P1|Participant Flow|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
153749|NCT01348425|O2|Outcome|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
153750|NCT01348425|O1|Outcome|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
153751|NCT01348425|E1|Reported Event|Stented Patients|The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
153752|NCT01348165|B8|Baseline|Total|Total of all reporting groups
153753|NCT01348165|B7|Baseline|0.6 mg|BI 137882 with 0.6 mg Dose level
153754|NCT01348165|B6|Baseline|0.5 mg|BI 137882 with 0.5 mg Dose level
153755|NCT01348165|B5|Baseline|0.25 mg|BI 137882 with 0.25 mg Dose level
153756|NCT01348165|B4|Baseline|0.1 mg|BI 137882 with 0.1 mg Dose level
153757|NCT01348165|B3|Baseline|0.03 mg|BI 137882 with 0.03 mg Dose level
153758|NCT01348165|B2|Baseline|0.01 mg|BI 137882 with 0.01 mg Dose level
153759|NCT01348165|B1|Baseline|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153760|NCT01348165|P7|Participant Flow|0.6 mg|BI 137882 with 0.6 mg Dose level
153761|NCT01348165|P6|Participant Flow|0.5 mg|BI 137882 with 0.5 mg Dose level
153762|NCT01348165|P5|Participant Flow|0.25 mg|BI 137882 with 0.25 mg Dose level
153763|NCT01348165|P4|Participant Flow|0.1 mg|BI 137882 with 0.1 mg Dose level
153764|NCT01348165|P3|Participant Flow|0.03 mg|BI 137882 with 0.03 mg Dose level
153765|NCT01348165|P2|Participant Flow|0.01 mg|BI 137882 with 0.01 mg Dose level
153766|NCT01348165|P1|Participant Flow|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
153767|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153773|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153774|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153775|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153776|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153777|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153778|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153779|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153780|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153781|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153782|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153783|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153784|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153785|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153786|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153787|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153788|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153789|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153790|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153791|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153792|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153793|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153794|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153795|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153796|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153797|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153798|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153799|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153800|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153801|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153802|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153803|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153804|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153805|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153806|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153807|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153808|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153809|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153810|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153811|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153812|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153813|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153814|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153815|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153816|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153817|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153818|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153819|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153820|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153821|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153822|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153823|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153824|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153825|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153826|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153827|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153828|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153829|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153830|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153831|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153832|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153833|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153834|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153835|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153836|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153837|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153838|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153839|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153840|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153841|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153842|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153843|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153844|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153845|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153846|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153847|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153848|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153849|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153865|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153866|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153867|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153868|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153869|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153870|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153871|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153872|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153873|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153874|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153875|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153876|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153877|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153878|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153879|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153880|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
153881|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
153882|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
153883|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
153884|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
153885|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
153886|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
153887|NCT01348165|E7|Reported Event|0.6 mg|BI 137882 with 0.6 mg Dose level
153888|NCT01348165|E6|Reported Event|0.5 mg|BI 137882 with 0.5 mg Dose level
153889|NCT01348165|E5|Reported Event|0.25 mg|BI 137882 with 0.25 mg Dose level
153890|NCT01348165|E4|Reported Event|0.1 mg|BI 137882 with 0.1 mg Dose level
153891|NCT01348165|E3|Reported Event|0.03 mg|BI 137882 with 0.03 mg Dose level
153892|NCT01348165|E2|Reported Event|0.01 mg|BI 137882 with 0.01 mg Dose level
153893|NCT01348165|E1|Reported Event|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
153894|NCT01348139|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
153895|NCT01348139|P6|Participant Flow|Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg|Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
153896|NCT01348139|P5|Participant Flow|1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg|AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.
153897|NCT01348139|P4|Participant Flow|300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg|AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.
153898|NCT01348139|P3|Participant Flow|800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo|AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.
153899|NCT01348139|P2|Participant Flow|880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg|AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.
153900|NCT01348139|P1|Participant Flow|1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg|AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.
153901|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153902|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153903|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153904|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153905|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153906|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153907|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153908|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153909|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153910|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153911|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153912|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153913|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153914|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153915|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153916|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153917|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153918|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153919|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153920|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153921|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153922|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153923|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153924|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153925|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153926|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153927|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153930|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153931|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153932|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153933|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153934|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153935|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153936|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153937|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153938|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153939|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153940|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153941|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153942|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153943|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153944|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153945|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153946|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153947|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153948|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153949|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153950|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153951|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153952|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153953|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153954|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153955|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153956|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153957|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153958|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153959|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153960|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153961|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
153962|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153963|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153964|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
153965|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
153966|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
153967|NCT01348139|E6|Reported Event|Placebo|Placebo
153968|NCT01348139|E5|Reported Event|AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
153969|NCT01348139|E4|Reported Event|AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
153970|NCT01348139|E3|Reported Event|AZD3199 800 μg|AZD3199 800 μg SID
153971|NCT01348139|E2|Reported Event|AZD3199 880 μg|AZD3199 880 μg SID
153972|NCT01348139|E1|Reported Event|AZD3199 1400 μg|AZD3199 1400 μg SID
153973|NCT01348100|B8|Baseline|Total|Total of all reporting groups
153974|NCT01348100|B7|Baseline|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153975|NCT01348100|B6|Baseline|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153976|NCT01348100|B5|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153977|NCT01348100|B4|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153978|NCT01348100|B3|Baseline|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153979|NCT01348100|B2|Baseline|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
153980|NCT01348100|B1|Baseline|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
153981|NCT01348100|P7|Participant Flow|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153982|NCT01348100|P6|Participant Flow|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153983|NCT01348100|P5|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153984|NCT01348100|P4|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153985|NCT01348100|P3|Participant Flow|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153986|NCT01348100|P2|Participant Flow|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
153987|NCT01348100|P1|Participant Flow|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
153988|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153989|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153990|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153991|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153992|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153993|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153994|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153995|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153996|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153997|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153998|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
153999|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154000|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154001|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154002|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154062|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
174956|NCT01272583|O2|Outcome|Sitagliptin Treatment|
154003|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154004|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154005|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154006|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154007|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154008|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154009|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154010|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154011|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154012|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154013|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154014|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154015|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154016|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154017|NCT01348100|E14|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart.
154018|NCT01348100|E13|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart.
154019|NCT01348100|E12|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart.
154020|NCT01348100|E11|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154021|NCT01348100|E10|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154022|NCT01348100|E9|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154023|NCT01348100|E8|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time.
154024|NCT01348100|E7|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Depot|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time.
154025|NCT01348100|E6|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154063|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
174957|NCT01272583|O1|Outcome|Baseline|
154026|NCT01348100|E5|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
154027|NCT01348100|E4|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time.
154028|NCT01348100|E3|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time.
154029|NCT01348100|E2|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
154030|NCT01348100|E1|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
154031|NCT01348087|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
154032|NCT01348087|P1|Participant Flow|AFQ056 Total|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
154033|NCT01348087|O6|Outcome|AFQ056 Total|
154034|NCT01348087|O5|Outcome|AFQ056 100mg Bid|
154035|NCT01348087|O4|Outcome|AFQ056 75mg Bid|
154036|NCT01348087|O3|Outcome|AFQ056 50mg Bid|
154037|NCT01348087|O2|Outcome|AFQ056 25mg Bid|
154038|NCT01348087|O1|Outcome|Prior to Ext First Dose|
154039|NCT01348087|E6|Reported Event|AFQ056 Total|
154040|NCT01348087|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
154041|NCT01348087|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
154042|NCT01348087|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
154043|NCT01348087|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
154044|NCT01348087|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
154045|NCT01347931|B1|Baseline|Overall Study Group|All subjects participating in 2-way crossover design study
154046|NCT01347931|P1|Participant Flow|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154047|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154048|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154049|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154050|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154051|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154052|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154053|NCT01347931|E2|Reported Event|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154054|NCT01347931|E1|Reported Event|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
154055|NCT01347879|B3|Baseline|Total|Total of all reporting groups
154056|NCT01347879|B2|Baseline|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154057|NCT01347879|B1|Baseline|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154058|NCT01347879|P2|Participant Flow|Visonac Cream With PDT|"active treatment with light dose of 37 J/cm2~Visonac photodynamic therapy (PDT): cream application prior to illumination with red light"
154059|NCT01347879|P1|Participant Flow|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154060|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154061|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154340|NCT01347073|O1|Outcome|NaPBA|Switch Over
154064|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154065|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154066|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154067|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154068|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154069|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154070|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154071|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154072|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154073|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154074|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154075|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154076|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154077|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154078|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154079|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154080|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154081|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154082|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154083|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154084|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154085|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154086|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154087|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154088|NCT01347879|E2|Reported Event|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
154089|NCT01347879|E1|Reported Event|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
154090|NCT01347840|B1|Baseline|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154091|NCT01347840|P1|Participant Flow|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154092|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154093|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154094|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154095|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154096|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154097|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154098|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154099|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154100|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154101|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154102|NCT01347840|E1|Reported Event|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
154103|NCT01347788|B1|Baseline|Cabozantinib|"Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.~A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.~Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.~Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org"
154104|NCT01347788|P3|Participant Flow|Expansion Cohort|Cabozantinib 40 mg daily
154105|NCT01347788|P2|Participant Flow|Dose Level -1|Cabozantinib 20 mg daily
154106|NCT01347788|P1|Participant Flow|Dose Level 0|Cabozantinib 40 mg daily
154107|NCT01347788|O3|Outcome|Expansion Cohort|Dose level 0: cabozantinib 40 mg daily
154108|NCT01347788|O2|Outcome|Cohort 2|Dose level -1: cabozantinib 20 mg daily
154109|NCT01347788|O1|Outcome|Cohort 1|Dose level 0: cabozantinib 40 mg daily
154110|NCT01347788|E3|Reported Event|Cohort 3|Dose level 0: cabozantinib 40 mg daily
154111|NCT01347788|E2|Reported Event|Cohort 2|Dose level -1: cabozantinib 20 mg daily
154112|NCT01347788|E1|Reported Event|Cohort 1|Dose level 0: cabozantinib 40 mg daily
154113|NCT01347710|B1|Baseline|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154114|NCT01347710|P1|Participant Flow|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154115|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154116|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154117|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154118|NCT01347710|O1|Outcome|Flurpiridaz F18|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154119|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
154120|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154121|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154122|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154123|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154124|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154125|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154126|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
154127|NCT01347710|E1|Reported Event|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
154128|NCT01347632|B1|Baseline|Metronidazole|Open Label Study
154129|NCT01347632|P1|Participant Flow|Metronidazole|Open Label Study
154130|NCT01347632|O1|Outcome|Metronidazole|Open Label Study
154131|NCT01347632|E1|Reported Event|Metronidazole|Open Label Study
154132|NCT01347580|B3|Baseline|Total|Total of all reporting groups
154133|NCT01347580|B2|Baseline|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154134|NCT01347580|B1|Baseline|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154135|NCT01347580|P2|Participant Flow|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154136|NCT01347580|P1|Participant Flow|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154137|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154138|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154139|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154140|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154141|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154142|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154143|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154144|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154145|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154146|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154147|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154148|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154149|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154150|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154151|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154152|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154153|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154154|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154155|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154156|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154157|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154158|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154159|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154160|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154161|NCT01347580|E2|Reported Event|Ticagrelor Pre-Hosp|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154162|NCT01347580|E1|Reported Event|Ticagrelor In-Hosp|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
154163|NCT01347554|B3|Baseline|Total|Total of all reporting groups
154164|NCT01347554|B2|Baseline|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154165|NCT01347554|B1|Baseline|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154166|NCT01347554|P2|Participant Flow|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154167|NCT01347554|P1|Participant Flow|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154168|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154169|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154170|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154171|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154172|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154173|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154174|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154175|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
174958|NCT01272583|E3|Reported Event|Placebo|
154176|NCT01347554|E2|Reported Event|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
154177|NCT01347554|E1|Reported Event|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
154178|NCT01347255|B1|Baseline|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)~Daivobet® ointment: once daily application, 4 weeks (6 days a week)"
154179|NCT01347255|P1|Participant Flow|All Study Participants|"All subjects received all four treatments:~LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients~Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)~Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.~The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks."
154180|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
154181|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
154182|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
154183|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
154184|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
154185|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
154186|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
154187|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
154188|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
154189|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
154190|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
154191|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
154192|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
154193|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
154194|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
154195|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
154196|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
154197|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
154198|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
154199|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
154200|NCT01347255|E1|Reported Event|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4weeks~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks~Daivobet® ointment: once daily application, 4weeks"
154201|NCT01347112|B3|Baseline|Total|Total of all reporting groups
154202|NCT01347112|B2|Baseline|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154203|NCT01347112|B1|Baseline|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154204|NCT01347112|P2|Participant Flow|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154205|NCT01347112|P1|Participant Flow|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154206|NCT01347112|O2|Outcome|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154207|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154208|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154209|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154210|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154211|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154212|NCT01347112|E2|Reported Event|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
154213|NCT01347112|E1|Reported Event|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
154214|NCT01347086|B11|Baseline|Total|Total of all reporting groups
154215|NCT01347086|B10|Baseline|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154216|NCT01347086|B9|Baseline|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154217|NCT01347086|B8|Baseline|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154218|NCT01347086|B7|Baseline|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154219|NCT01347086|B6|Baseline|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154220|NCT01347086|B5|Baseline|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154221|NCT01347086|B4|Baseline|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154222|NCT01347086|B3|Baseline|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154223|NCT01347086|B2|Baseline|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154224|NCT01347086|B1|Baseline|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154225|NCT01347086|P10|Participant Flow|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154226|NCT01347086|P9|Participant Flow|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154227|NCT01347086|P8|Participant Flow|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154228|NCT01347086|P7|Participant Flow|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154229|NCT01347086|P6|Participant Flow|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154230|NCT01347086|P5|Participant Flow|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154231|NCT01347086|P4|Participant Flow|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154232|NCT01347086|P3|Participant Flow|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154233|NCT01347086|P2|Participant Flow|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154234|NCT01347086|P1|Participant Flow|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154235|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154236|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154237|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154238|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154239|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154240|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154241|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154242|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154243|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154244|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154245|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154246|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154247|NCT01347086|O3|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154248|NCT01347086|O2|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154249|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154250|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154251|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154252|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154253|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154341|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment Arm
154254|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154255|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154256|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154257|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154258|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154259|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154260|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154261|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154262|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154263|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154264|NCT01347086|O5|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154265|NCT01347086|O4|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154266|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154267|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154268|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154269|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154270|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154271|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154272|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154273|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154274|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154275|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154276|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154277|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154278|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154279|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154280|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154281|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154282|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154283|NCT01347086|O4|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154284|NCT01347086|O3|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154285|NCT01347086|O2|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154286|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154287|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154288|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154289|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154290|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154291|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154292|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154293|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154294|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154295|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154296|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154342|NCT01347073|O1|Outcome|NaPBA|Switch Over Arm
154297|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154298|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154299|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154300|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154301|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154302|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154303|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154304|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154305|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154306|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154307|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154308|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154309|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154310|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154311|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154312|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154313|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154314|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154315|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154316|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154317|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154318|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154319|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154320|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154321|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154322|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154323|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154324|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154325|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154326|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
154327|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
154328|NCT01347086|E4|Reported Event|1200 mg Deleobuvir|All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
154329|NCT01347086|E3|Reported Event|800 mg Deleobuvir|All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
154330|NCT01347086|E2|Reported Event|400 mg Deleobuvir|All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
154331|NCT01347086|E1|Reported Event|Placebo|All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
154332|NCT01347073|B1|Baseline|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
154333|NCT01347073|P1|Participant Flow|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
154334|NCT01347073|O1|Outcome|HPN-100|Long Term Treatment
154335|NCT01347073|O2|Outcome|Long-term Phase|The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
154336|NCT01347073|O1|Outcome|Pre-enrollment|12-months preceding the study
154337|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
154338|NCT01347073|O1|Outcome|NaPBA|Switch Over
154339|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
154343|NCT01347073|E1|Reported Event|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
154344|NCT01347060|B3|Baseline|Total|Total of all reporting groups
154345|NCT01347060|B2|Baseline|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154346|NCT01347060|B1|Baseline|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154347|NCT01347060|P2|Participant Flow|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154348|NCT01347060|P1|Participant Flow|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154349|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154350|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154351|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154352|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154353|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154354|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154355|NCT01347060|E2|Reported Event|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154356|NCT01347060|E1|Reported Event|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
154357|NCT01347034|B3|Baseline|Total|Total of all reporting groups
154358|NCT01347034|B2|Baseline|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
154359|NCT01347034|B1|Baseline|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
154360|NCT01347034|P2|Participant Flow|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
154361|NCT01347034|P1|Participant Flow|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
154362|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
154363|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
154364|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
154365|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
154366|NCT01347034|E2|Reported Event|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
154415|NCT01346774|O1|Outcome|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
154367|NCT01347034|E1|Reported Event|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
154368|NCT01347008|B3|Baseline|Total|Total of all reporting groups
154369|NCT01347008|B2|Baseline|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154370|NCT01347008|B1|Baseline|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154371|NCT01347008|P2|Participant Flow|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154372|NCT01347008|P1|Participant Flow|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154373|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154374|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154375|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154376|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154377|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154378|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154379|NCT01347008|E2|Reported Event|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
154380|NCT01347008|E1|Reported Event|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
154381|NCT01346852|B3|Baseline|Total|Total of all reporting groups
154382|NCT01346852|B2|Baseline|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154383|NCT01346852|B1|Baseline|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154384|NCT01346852|P2|Participant Flow|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154385|NCT01346852|P1|Participant Flow|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154386|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154387|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154388|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154389|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154390|NCT01346852|E2|Reported Event|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154416|NCT01346774|E2|Reported Event|Placebo Capsules|Placebo powder: 2 placebo powder capsules twice a day
154417|NCT01346774|E1|Reported Event|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
154418|NCT01346592|B4|Baseline|Total|Total of all reporting groups
154391|NCT01346852|E1|Reported Event|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
154392|NCT01346839|B3|Baseline|Total|Total of all reporting groups
154393|NCT01346839|B2|Baseline|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154394|NCT01346839|B1|Baseline|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154395|NCT01346839|P2|Participant Flow|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154396|NCT01346839|P1|Participant Flow|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154397|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154398|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154399|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154400|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
155027|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
154401|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154402|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154403|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154404|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154405|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154406|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154407|NCT01346839|E2|Reported Event|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
154408|NCT01346839|E1|Reported Event|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
154409|NCT01346774|B3|Baseline|Total|Total of all reporting groups
154410|NCT01346774|B2|Baseline|Placebo|Placebo powder: 2 placebo powder capsules twice a day
154411|NCT01346774|B1|Baseline|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
154412|NCT01346774|P2|Participant Flow|Placebo|Placebo powder: 2 placebo powder capsules twice a day
154413|NCT01346774|P1|Participant Flow|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
154414|NCT01346774|O2|Outcome|Placebo|Placebo powder: 2 placebo powder capsules twice a day
154419|NCT01346592|B3|Baseline|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154420|NCT01346592|B2|Baseline|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154421|NCT01346592|B1|Baseline|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154422|NCT01346592|P3|Participant Flow|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154423|NCT01346592|P2|Participant Flow|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154424|NCT01346592|P1|Participant Flow|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154425|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154426|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154427|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154428|NCT01346592|O3|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154429|NCT01346592|O2|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154430|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154431|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154432|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154433|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154434|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154435|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154436|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154437|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154438|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154439|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154440|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
154441|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154442|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154443|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
154444|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154445|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154446|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
154447|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154448|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154449|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
154450|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154451|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154452|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
154453|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154454|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154455|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
154456|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154457|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154458|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
154459|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154460|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154461|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
154462|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154463|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154464|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
154465|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154466|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154467|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
154468|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154469|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154470|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
154471|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
154472|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
154473|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
154474|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154475|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154476|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154477|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
155028|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
155029|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
154478|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154479|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154480|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154481|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154482|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154483|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154484|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154485|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154486|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154487|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154488|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154489|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154490|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154491|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154492|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154493|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154494|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
154495|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
154496|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
154497|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
154498|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
154499|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
154500|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
154501|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
154502|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
154503|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
154504|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154505|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154506|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154507|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
154508|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154509|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
154510|NCT01346592|E3|Reported Event|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154511|NCT01346592|E2|Reported Event|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154512|NCT01346592|E1|Reported Event|ATIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
154513|NCT01346501|B3|Baseline|Total|Total of all reporting groups
154514|NCT01346501|B2|Baseline|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154515|NCT01346501|B1|Baseline|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154516|NCT01346501|P2|Participant Flow|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154517|NCT01346501|P1|Participant Flow|Adalimumab|Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
154518|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707.
154519|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154520|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154521|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154522|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154523|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154524|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154525|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
154526|NCT01346501|O1|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score <3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
154527|NCT01346501|E2|Reported Event|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
154528|NCT01346501|E1|Reported Event|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
154529|NCT01346397|B3|Baseline|Total|Total of all reporting groups
154530|NCT01346397|B2|Baseline|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
154531|NCT01346397|B1|Baseline|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
154532|NCT01346397|P2|Participant Flow|Tacrolimus Group|tacrolimus group - after Campath induction tacrolimus will be administered
154533|NCT01346397|P1|Participant Flow|Cyclosporine Group|cyclosporine group - after Campath induction cyclosporine will be administered
154534|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
154535|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
154536|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
154537|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
154600|NCT01345929|E1|Reported Event|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
154538|NCT01346397|E2|Reported Event|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
154539|NCT01346397|E1|Reported Event|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
154540|NCT01346293|B3|Baseline|Total|Total of all reporting groups
154541|NCT01346293|B2|Baseline|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154542|NCT01346293|B1|Baseline|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154543|NCT01346293|P2|Participant Flow|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154544|NCT01346293|P1|Participant Flow|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154545|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154546|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154547|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154548|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154549|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154550|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154551|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154552|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154553|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154554|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154555|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154556|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154557|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154558|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154559|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154560|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154561|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154562|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154563|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154564|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154565|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154566|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154567|NCT01346293|E2|Reported Event|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
154568|NCT01346293|E1|Reported Event|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
154569|NCT01346176|B4|Baseline|Total|Total of all reporting groups
154570|NCT01346176|B3|Baseline|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
154601|NCT01345786|B5|Baseline|Total|Total of all reporting groups
154571|NCT01346176|B2|Baseline|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
154572|NCT01346176|B1|Baseline|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
154573|NCT01346176|P3|Participant Flow|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
154574|NCT01346176|P2|Participant Flow|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
154575|NCT01346176|P1|Participant Flow|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
154576|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
154577|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
154578|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
154579|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
154580|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
154581|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
154582|NCT01346176|E3|Reported Event|Positive Default|
154583|NCT01346176|E2|Reported Event|Negative Default|
154584|NCT01346176|E1|Reported Event|Forced Choice|
154585|NCT01346085|B1|Baseline|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
154586|NCT01346085|P1|Participant Flow|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
154587|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
154588|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
154589|NCT01346085|E1|Reported Event|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
154590|NCT01345929|B3|Baseline|Total|Total of all reporting groups
154591|NCT01345929|B2|Baseline|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
154592|NCT01345929|B1|Baseline|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
154593|NCT01345929|P2|Participant Flow|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days~Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin."
154594|NCT01345929|P1|Participant Flow|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days~Of the 1083 subjects in the integrated analysis set, 533 received CXA."
154595|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
154596|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
154597|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
154598|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
154599|NCT01345929|E2|Reported Event|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
155030|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
154602|NCT01345786|B4|Baseline|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
154603|NCT01345786|B3|Baseline|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
154604|NCT01345786|B2|Baseline|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
154605|NCT01345786|B1|Baseline|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
154606|NCT01345786|P4|Participant Flow|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
154607|NCT01345786|P3|Participant Flow|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
154608|NCT01345786|P2|Participant Flow|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
154609|NCT01345786|P1|Participant Flow|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
154610|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154611|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154612|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154613|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154614|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154615|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154616|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154617|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154635|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154618|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154619|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154620|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154621|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154622|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154623|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154624|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154625|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154626|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154627|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154628|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154629|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154630|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154631|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154632|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154633|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154634|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154679|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154636|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154637|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154638|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154639|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154640|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154641|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154642|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154643|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154644|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154645|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154646|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154647|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154648|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154649|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154650|NCT01345786|E4|Reported Event|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154651|NCT01345786|E3|Reported Event|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
154652|NCT01345786|E2|Reported Event|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154723|NCT01345630|B1|Baseline|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154653|NCT01345786|E1|Reported Event|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
154654|NCT01345721|B4|Baseline|Total|Total of all reporting groups
154655|NCT01345721|B3|Baseline|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154656|NCT01345721|B2|Baseline|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154657|NCT01345721|B1|Baseline|MenACWY (2 Primary +1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154658|NCT01345721|P3|Participant Flow|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154659|NCT01345721|P2|Participant Flow|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154660|NCT01345721|P1|Participant Flow|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154661|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154662|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154663|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154664|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154665|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154666|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154667|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
154668|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
154669|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
154670|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
154671|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154672|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154673|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154674|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154675|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154676|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154677|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154678|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154785|NCT01345292|P2|Participant Flow|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
174959|NCT01272583|E2|Reported Event|Sitagliptin Treatment|
154680|NCT01345721|O3|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154681|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154682|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154683|NCT01345721|E3|Reported Event|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
154684|NCT01345721|E2|Reported Event|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154685|NCT01345721|E1|Reported Event|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
154686|NCT01345682|B3|Baseline|Total|Total of all reporting groups
154687|NCT01345682|B2|Baseline|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154688|NCT01345682|B1|Baseline|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154689|NCT01345682|P2|Participant Flow|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154690|NCT01345682|P1|Participant Flow|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154691|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154692|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154693|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154694|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154695|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154696|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154697|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154698|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154699|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154700|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154701|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
174960|NCT01272583|E1|Reported Event|Baseline|
154702|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154703|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154704|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154705|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154706|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154707|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154708|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154709|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154710|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154711|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154712|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154713|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154714|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154715|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154716|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154717|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154718|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154719|NCT01345682|E2|Reported Event|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154720|NCT01345682|E1|Reported Event|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
154721|NCT01345630|B3|Baseline|Total|Total of all reporting groups
154722|NCT01345630|B2|Baseline|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
177082|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
154724|NCT01345630|P2|Participant Flow|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154725|NCT01345630|P1|Participant Flow|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154726|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154727|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154728|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154729|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154730|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154731|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154732|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154733|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154734|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154735|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154736|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154737|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154738|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154739|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154740|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154741|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154742|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154743|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154744|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154745|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154746|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154747|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154748|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154749|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154750|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154751|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154752|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154753|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154786|NCT01345292|P1|Participant Flow|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154754|NCT01345630|O4|Outcome|FTC/TDF+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
154755|NCT01345630|O3|Outcome|FTC/TDF+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
154756|NCT01345630|O2|Outcome|MVC+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
154757|NCT01345630|O1|Outcome|MVC+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
154758|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154759|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154760|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154761|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154762|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154763|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154764|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154765|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154766|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154767|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154768|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154769|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154770|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154771|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154772|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154773|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154774|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154775|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154776|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154777|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154778|NCT01345630|E2|Reported Event|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
154779|NCT01345630|E1|Reported Event|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
154780|NCT01345292|B4|Baseline|Total|Total of all reporting groups
154781|NCT01345292|B3|Baseline|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154782|NCT01345292|B2|Baseline|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154783|NCT01345292|B1|Baseline|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154784|NCT01345292|P3|Participant Flow|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
177083|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
154787|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154788|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154789|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154790|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154791|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154792|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154793|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154794|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154795|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154796|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154797|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154798|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154799|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154800|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154801|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154802|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154803|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154804|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154805|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154806|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154807|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154808|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154809|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154810|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154811|NCT01345292|E3|Reported Event|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
154812|NCT01345292|E2|Reported Event|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
154813|NCT01345292|E1|Reported Event|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
154814|NCT01345253|B3|Baseline|Total|Total of all reporting groups
154815|NCT01345253|B2|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154816|NCT01345253|B1|Baseline|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154817|NCT01345253|P2|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154818|NCT01345253|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154819|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154820|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154821|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154822|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154823|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154824|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154825|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154826|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154827|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154828|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154829|NCT01345253|E2|Reported Event|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154830|NCT01345253|E1|Reported Event|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
154831|NCT01345240|B6|Baseline|Total|Total of all reporting groups
154832|NCT01345240|B5|Baseline|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154833|NCT01345240|B4|Baseline|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154834|NCT01345240|B3|Baseline|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154835|NCT01345240|B2|Baseline|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154836|NCT01345240|B1|Baseline|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154837|NCT01345240|P5|Participant Flow|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154838|NCT01345240|P4|Participant Flow|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
155031|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
154839|NCT01345240|P3|Participant Flow|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154840|NCT01345240|P2|Participant Flow|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154841|NCT01345240|P1|Participant Flow|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154842|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154843|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154844|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154845|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154951|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154952|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
155032|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
154846|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154847|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154848|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154849|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154850|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154851|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154852|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154953|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154954|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154955|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154853|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154854|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154855|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154856|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154857|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154858|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154859|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154956|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154957|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154958|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154860|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154861|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154862|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154863|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154864|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154865|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154866|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154959|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154960|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
180798|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
154867|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154868|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154869|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154870|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154871|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154872|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154873|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154961|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154962|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154963|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
180799|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
154874|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154875|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154876|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154877|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154878|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154879|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154880|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154964|NCT01345123|E3|Reported Event|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154965|NCT01345123|E2|Reported Event|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
155033|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
155034|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
154881|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154882|NCT01345240|O2|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154883|NCT01345240|O1|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154884|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154885|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154886|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154887|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154888|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
155035|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
154889|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154890|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154891|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154892|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154893|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154894|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154895|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154919|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154896|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154897|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154898|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154899|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154900|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154901|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154902|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154903|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154945|NCT01345123|B1|Baseline|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154904|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154905|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154906|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154907|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154908|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154909|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154910|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154946|NCT01345123|P3|Participant Flow|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154947|NCT01345123|P2|Participant Flow|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154948|NCT01345123|P1|Participant Flow|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154911|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154912|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154913|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154914|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154915|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154916|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154917|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154918|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154949|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
155022|NCT01344629|P1|Participant Flow|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
154920|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154921|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154922|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154923|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154924|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154925|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154926|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154927|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
155023|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
154928|NCT01345240|E5|Reported Event|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154929|NCT01345240|E4|Reported Event|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154930|NCT01345240|E3|Reported Event|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154931|NCT01345240|E2|Reported Event|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154932|NCT01345240|E1|Reported Event|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
154933|NCT01345162|B3|Baseline|Total|Total of all reporting groups
154934|NCT01345162|B2|Baseline|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154935|NCT01345162|B1|Baseline|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154936|NCT01345162|P2|Participant Flow|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154937|NCT01345162|P1|Participant Flow|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154938|NCT01345162|O2|Outcome|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154939|NCT01345162|O1|Outcome|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154940|NCT01345162|E2|Reported Event|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154941|NCT01345162|E1|Reported Event|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
154942|NCT01345123|B4|Baseline|Total|Total of all reporting groups
154943|NCT01345123|B3|Baseline|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
154944|NCT01345123|B2|Baseline|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154950|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
154966|NCT01345123|E1|Reported Event|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
154967|NCT01344876|B1|Baseline|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
154968|NCT01344876|P5|Participant Flow|OPB-51602: 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154969|NCT01344876|P4|Participant Flow|OPB-51602: 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154970|NCT01344876|P3|Participant Flow|OPB-51602: 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154971|NCT01344876|P2|Participant Flow|OPB-51602: 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154972|NCT01344876|P1|Participant Flow|OPB-51602: 1mg/Day|OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154973|NCT01344876|O5|Outcome|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154974|NCT01344876|O4|Outcome|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154975|NCT01344876|O3|Outcome|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154976|NCT01344876|O2|Outcome|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154977|NCT01344876|O1|Outcome|OPB-51602 1m/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154978|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
154979|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
154980|NCT01344876|E5|Reported Event|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154981|NCT01344876|E4|Reported Event|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154982|NCT01344876|E3|Reported Event|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154983|NCT01344876|E2|Reported Event|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154984|NCT01344876|E1|Reported Event|OPB-51602 1mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
154985|NCT01344759|B3|Baseline|Total|Total of all reporting groups
154986|NCT01344759|B2|Baseline|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
154987|NCT01344759|B1|Baseline|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
154988|NCT01344759|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
154989|NCT01344759|P1|Participant Flow|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
154990|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
154991|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
154992|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
154993|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
154994|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
154995|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
154996|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
154997|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
154998|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155024|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
155025|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
155026|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
154999|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155000|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155001|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155002|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155003|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155004|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155005|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155006|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155007|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155008|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155009|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155010|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155011|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155012|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
155013|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
155014|NCT01344759|O2|Outcome|Dexmedetomidine|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose)."
155015|NCT01344759|O1|Outcome|Propofol|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose)."
155016|NCT01344759|E2|Reported Event|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
155017|NCT01344759|E1|Reported Event|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
155018|NCT01344629|B3|Baseline|Total|Total of all reporting groups
155019|NCT01344629|B2|Baseline|Treatment Sequence B|
155020|NCT01344629|B1|Baseline|Treatment Sequence A|
155021|NCT01344629|P2|Participant Flow|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
155037|NCT01344629|E2|Reported Event|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
155038|NCT01344629|E1|Reported Event|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
155039|NCT01344616|B3|Baseline|Total|Total of all reporting groups
155040|NCT01344616|B2|Baseline|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
155041|NCT01344616|B1|Baseline|Usual Clinical Care|usual clinical care with no intervention
155042|NCT01344616|P2|Participant Flow|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
155043|NCT01344616|P1|Participant Flow|Usual Clinical Care|usual clinical care with no intervention
155044|NCT01344616|O2|Outcome|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
155045|NCT01344616|O1|Outcome|Usual Clinical Care|usual clinical care with no intervention
155046|NCT01344616|E2|Reported Event|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
155047|NCT01344616|E1|Reported Event|Usual Clinical Care|usual clinical care with no intervention
155048|NCT01343485|B3|Baseline|Total|Total of all reporting groups
155049|NCT01343485|B2|Baseline|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
155050|NCT01343485|B1|Baseline|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
155051|NCT01343485|P2|Participant Flow|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
155052|NCT01343485|P1|Participant Flow|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
155053|NCT01343485|O2|Outcome|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
155054|NCT01343485|O1|Outcome|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
155055|NCT01343485|E2|Reported Event|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
155056|NCT01343485|E1|Reported Event|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
155057|NCT01344538|B3|Baseline|Total|Total of all reporting groups
155058|NCT01344538|B2|Baseline|Lactose Capsule|Placebo Capsule : 2.0 g per day
155059|NCT01344538|B1|Baseline|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
155060|NCT01344538|P2|Participant Flow|Lactose Capsule|Placebo Capsule : 2.0 g per day
155061|NCT01344538|P1|Participant Flow|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
155062|NCT01344538|O2|Outcome|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
155063|NCT01344538|O1|Outcome|Lactose Capsule|Placebo Capsule : 2.0 g per day
155064|NCT01344538|E2|Reported Event|Lactose Capsule|Placebo Capsule: 2.0 g per day
155065|NCT01344538|E1|Reported Event|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
155066|NCT01344460|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155067|NCT01344460|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155068|NCT01344460|O2|Outcome|Unenhanced MRA|
155069|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155070|NCT01344460|O2|Outcome|Unenhanced MRA|
155071|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155072|NCT01344460|O2|Outcome|Unenhanced MRA|
155073|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155074|NCT01344460|O2|Outcome|Unenhanced MRA|
155075|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155076|NCT01344460|O2|Outcome|Unenhanced MRA|
155077|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155078|NCT01344460|O2|Outcome|Unenhanced MRA|
155079|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
155080|NCT01344460|O2|Outcome|Unenhanced MRA|
155110|NCT01344460|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155111|NCT01344447|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155112|NCT01344447|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155113|NCT01344447|O2|Outcome|Unenhanced MRA|
155114|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155115|NCT01344447|O2|Outcome|Unenhanced MRA|
155116|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155117|NCT01344447|O2|Outcome|Unenhanced MRA|
155118|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155119|NCT01344447|O2|Outcome|Unenhanced MRA|
155120|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155121|NCT01344447|O2|Outcome|Unenhanced MRA|
155122|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155123|NCT01344447|O2|Outcome|Unenhanced MRA|
155124|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155125|NCT01344447|O2|Outcome|Unenhanced MRA|
155126|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155127|NCT01344447|O2|Outcome|Unenhanced MRA|
155128|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155129|NCT01344447|O2|Outcome|Unenhanced MRA|
155130|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155131|NCT01344447|O2|Outcome|Unenhanced MRA|
155132|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155133|NCT01344447|O2|Outcome|Unenhanced MRA|
155134|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155135|NCT01344447|O2|Outcome|Unenhanced MRA|
155136|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155137|NCT01344447|O2|Outcome|Unenhanced MRA|
155138|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155139|NCT01344447|O2|Outcome|Unenhanced MRA|
155140|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155141|NCT01344447|O3|Outcome|Computed Tomographic Angiography|
155142|NCT01344447|O2|Outcome|Unenhanced MRA|
155143|NCT01344447|O1|Outcome|Gadobutrol-Enhanced MRA|
155144|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155145|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155146|NCT01344447|O2|Outcome|Non-contrast MRA|
155147|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155148|NCT01344447|O2|Outcome|Non-contrast MRA|
155149|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155150|NCT01344447|O2|Outcome|Unenhanced MRA|
155151|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
155152|NCT01344447|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
155153|NCT01344369|B3|Baseline|Total|Total of all reporting groups
155154|NCT01344369|B2|Baseline|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
155155|NCT01344369|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
155156|NCT01344369|P2|Participant Flow|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
155157|NCT01344369|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
155158|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155159|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155160|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155161|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155162|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155163|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155164|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155165|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155166|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155167|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155168|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155169|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155170|NCT01344369|E2|Reported Event|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
155171|NCT01344369|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
155172|NCT01344161|B3|Baseline|Total|Total of all reporting groups
155173|NCT01344161|B2|Baseline|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
155174|NCT01344161|B1|Baseline|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
155175|NCT01344161|P2|Participant Flow|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
155176|NCT01344161|P1|Participant Flow|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
155177|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
155178|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
155179|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
155180|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
155181|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
155182|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
155183|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
155184|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
155185|NCT01344161|E2|Reported Event|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
155186|NCT01344161|E1|Reported Event|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
155187|NCT01344057|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155188|NCT01344057|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155189|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155190|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155191|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155192|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
155193|NCT01344057|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).
155194|NCT01343888|B4|Baseline|Total|Total of all reporting groups
155195|NCT01343888|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155196|NCT01343888|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155197|NCT01343888|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155198|NCT01343888|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155199|NCT01343888|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
155200|NCT01343888|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
155201|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155202|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155203|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155204|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155205|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
180800|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
155206|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155207|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155208|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155209|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155210|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155211|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155212|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155213|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155214|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155215|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155216|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155217|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155218|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155219|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155220|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155221|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155222|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155223|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155224|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155225|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155226|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155227|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155228|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155229|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155230|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155231|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155232|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155233|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155234|NCT01343888|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
155235|NCT01343888|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
155236|NCT01343888|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
155237|NCT01343823|B5|Baseline|Total|Total of all reporting groups
155238|NCT01343823|B4|Baseline|Placebo|
155239|NCT01343823|B3|Baseline|Ecallantide 60 mg|
155240|NCT01343823|B2|Baseline|Ecallantide 30 mg|
155241|NCT01343823|B1|Baseline|Ecallantide 10 mg|
155242|NCT01343823|P4|Participant Flow|Ecallantide 60mg|60 mg administered as two 30 mg SC injections of ecallantide
155243|NCT01343823|P3|Participant Flow|Ecallantide 30 mg|30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
155244|NCT01343823|P2|Participant Flow|Ecallantide 10 mg|10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
155245|NCT01343823|P1|Participant Flow|Placebo|Administered by two subcutaneous injections.
155246|NCT01343823|O4|Outcome|Ecallantide 60 mg|
155247|NCT01343823|O3|Outcome|Ecallantide 30 mg|
155248|NCT01343823|O2|Outcome|Ecallantide 10 mg|
155249|NCT01343823|O1|Outcome|Placebo|
155250|NCT01343823|O4|Outcome|Ecallantide 60 mg|
155251|NCT01343823|O3|Outcome|Ecallantide 30 mg|
155252|NCT01343823|O2|Outcome|Ecallantide 10 mg|
155253|NCT01343823|O1|Outcome|Placebo|
155254|NCT01343823|E4|Reported Event|Placebo|
155255|NCT01343823|E3|Reported Event|Ecallantide 60 mg|
155256|NCT01343823|E2|Reported Event|Ecallantide 30 mg|
155257|NCT01343823|E1|Reported Event|Ecallantide 10 mg|
155258|NCT01343667|B3|Baseline|Total|Total of all reporting groups
155259|NCT01343667|B2|Baseline|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
155260|NCT01343667|B1|Baseline|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
155261|NCT01343667|P2|Participant Flow|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
155262|NCT01343667|P1|Participant Flow|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
155263|NCT01343667|O2|Outcome|GEF EPD|"Carotid artery stenting with Gore Embolic Filter embolic protection device~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
155264|NCT01343667|O1|Outcome|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System embolic protection device~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
155265|NCT01343667|E2|Reported Event|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
155266|NCT01343667|E1|Reported Event|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
155267|NCT01343277|B3|Baseline|Total|Total of all reporting groups
155268|NCT01343277|B2|Baseline|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155269|NCT01343277|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155270|NCT01343277|P2|Participant Flow|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155271|NCT01343277|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155272|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155273|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155274|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155275|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155276|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155277|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155278|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155279|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155280|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155281|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155282|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155283|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155284|NCT01343277|E2|Reported Event|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
155285|NCT01343277|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
155286|NCT01343251|B3|Baseline|Total|Total of all reporting groups
155287|NCT01343251|B2|Baseline|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
155288|NCT01343251|B1|Baseline|HeRO Graft|patients who are evaluated and receive a HeRO graft implant for hemodialysis
155289|NCT01343251|P2|Participant Flow|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
155290|NCT01343251|P1|Participant Flow|HeRO Graft|patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
155291|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
155292|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
155293|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
155294|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
155295|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO
155296|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
155297|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
155298|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
155299|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
155300|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft Recipients
155301|NCT01343251|E2|Reported Event|Control|HeRO eligible patients who did not receive a HeRO Graft
155302|NCT01343251|E1|Reported Event|HeRO Graft|HeRO Graft recipients
155303|NCT01343082|B1|Baseline|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
155304|NCT01343082|P3|Participant Flow|Allocated to Tafluprost + Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
155305|NCT01343082|P2|Participant Flow|Allocated to Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
155306|NCT01343082|P1|Participant Flow|Allocated to Tafluprost|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
155307|NCT01343082|O1|Outcome|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
155308|NCT01343082|E1|Reported Event|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
155309|NCT01342965|B3|Baseline|Total|Total of all reporting groups
155310|NCT01342965|B2|Baseline|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155311|NCT01342965|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155312|NCT01342965|P2|Participant Flow|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155313|NCT01342965|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155314|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155315|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155316|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155317|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155318|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155319|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155320|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155321|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155322|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155323|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155324|NCT01342965|E2|Reported Event|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
155325|NCT01342965|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
155326|NCT01342913|B3|Baseline|Total|Total of all reporting groups
155327|NCT01342913|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155328|NCT01342913|B1|Baseline|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155329|NCT01342913|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155330|NCT01342913|P2|Participant Flow|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155331|NCT01342913|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
155332|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155333|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155334|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155335|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155336|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155337|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155338|NCT01342913|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
155339|NCT01342913|E1|Reported Event|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
155340|NCT01342770|B1|Baseline|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155341|NCT01342770|P1|Participant Flow|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155342|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155343|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155344|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155345|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155346|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155347|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155348|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155349|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155350|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155351|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155352|NCT01342770|E1|Reported Event|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
155353|NCT01342757|B1|Baseline|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
155354|NCT01342757|P1|Participant Flow|Vorinostat and Temozolomide|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
155355|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
155356|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
155357|NCT01342757|E1|Reported Event|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
155358|NCT01342666|B3|Baseline|Total|Total of all reporting groups
155359|NCT01342666|B2|Baseline|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
155360|NCT01342666|B1|Baseline|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
155361|NCT01342666|P2|Participant Flow|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
155362|NCT01342666|P1|Participant Flow|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
155363|NCT01342666|O2|Outcome|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
155364|NCT01342666|O1|Outcome|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
155365|NCT01342666|E2|Reported Event|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
155366|NCT01342666|E1|Reported Event|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
155367|NCT01342640|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
155368|NCT01342640|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s hemoglobin (Hb) level.
155369|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
155370|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
155371|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
155372|NCT01342640|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
155373|NCT01342549|B3|Baseline|Total|Total of all reporting groups
155374|NCT01342549|B2|Baseline|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
155375|NCT01342549|B1|Baseline|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
155376|NCT01342549|P2|Participant Flow|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
155377|NCT01342549|P1|Participant Flow|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
155378|NCT01342549|O2|Outcome|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
155379|NCT01342549|O1|Outcome|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
155380|NCT01342549|E2|Reported Event|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
155381|NCT01342549|E1|Reported Event|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
155382|NCT01342523|B33|Baseline|Total|Total of all reporting groups
155383|NCT01342523|B32|Baseline|CIS/Loz/Emails/Full Website/Full Booklet|
155384|NCT01342523|B31|Baseline|CIS/Loz/no Emails/Full Website/Full Booklet|
155385|NCT01342523|B30|Baseline|CIS/no Loz/Emails/Full Website/Full Booklet|
155386|NCT01342523|B29|Baseline|No CIS/Loz/Emails/Full Website/Full Booklet|
155387|NCT01342523|B28|Baseline|CIS/Loz/Emails/Lite Website/Full Booklet|
155388|NCT01342523|B27|Baseline|CIS/Loz/Emails/Full Website/Brief Booklet|
155389|NCT01342523|B26|Baseline|no CIS/no Loz/Emails/Full Website/Full Booklet|
155390|NCT01342523|B25|Baseline|No CIS/Loz/no Emails/Full Website/Full Booklet|
155391|NCT01342523|B24|Baseline|No CIS/Loz/Emails/Lite Website/Full Booklet|
155392|NCT01342523|B23|Baseline|No CIS/Loz/Emails/Full Website/Brief Booklet|
155393|NCT01342523|B22|Baseline|CIS/no Loz/no Email/Full Website/Full Booklet|
155394|NCT01342523|B21|Baseline|CIS/no Loz/Emails/Lite Website/Full Booklet|
155395|NCT01342523|B20|Baseline|CIS/no Loz/Emails/Full Website/Brief Booklet|
155396|NCT01342523|B19|Baseline|CIS/Loz/no Email/Lite Website/Full Booklet|
155397|NCT01342523|B18|Baseline|CIS/Loz/no Email/Full Website/Brief Booklet|
155398|NCT01342523|B17|Baseline|CIS/Loz/Emails/Lite Website/Brief Booklet|
155399|NCT01342523|B16|Baseline|no CIS/no Loz/no Email/Full Website/Full Booklet|
155400|NCT01342523|B15|Baseline|no CIS/no Loz/Emails/Lite Web/Full Booklet|
155401|NCT01342523|B14|Baseline|no CIS/no Loz/Emails/Full Website/Brief Booklet|
155402|NCT01342523|B13|Baseline|No CIS/Loz/No Emails/Full Website/Lite Booklet|
155403|NCT01342523|B12|Baseline|No CIS/Loz/No Emails/Lite Website/Full Booklet|
155404|NCT01342523|B11|Baseline|No CIS/Loz/Emails/Lite Website/Brief Booklet|
155405|NCT01342523|B10|Baseline|CIS/No Loz/no Email/Lite Website/Full Booklet|
155406|NCT01342523|B9|Baseline|CIS/No Loz/no Email/Full Website/Brief Booklet|
155407|NCT01342523|B8|Baseline|CIS/No Loz/Emails/Lite Website/Brief Booklet|
155408|NCT01342523|B7|Baseline|CIS/Loz/No Email/Lite Website/Brief Booklet|
155409|NCT01342523|B6|Baseline|No CIS/No Loz/No Email/Lite Website/Full Booklet|
155410|NCT01342523|B5|Baseline|No CIS/No Loz/No Email/Full Website/Brief Booklet|
155411|NCT01342523|B4|Baseline|No CIS/no Loz/Email/Lite Website/Brief Booklet|
155412|NCT01342523|B3|Baseline|no CIS/Loz/No Email/Lite Website/Brief Booklet|
155413|NCT01342523|B2|Baseline|CIS/No Loz/No Email/Lite Website/Brief Booklet|
155414|NCT01342523|B1|Baseline|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
155415|NCT01342523|P32|Participant Flow|CIS/Loz/Emails/Full Website/Full Booklet|
155416|NCT01342523|P31|Participant Flow|CIS/Loz/no Emails/Full Website/Full Booklet|
155417|NCT01342523|P30|Participant Flow|CIS/no Loz/Emails/Full Website/Full Booklet|
155418|NCT01342523|P29|Participant Flow|No CIS/Loz/Emails/Full Website/Full Booklet|
155419|NCT01342523|P28|Participant Flow|CIS/Loz/Emails/Lite Website/Full Booklet|
155420|NCT01342523|P27|Participant Flow|CIS/Loz/Emails/Full Website/Brief Booklet|
155421|NCT01342523|P26|Participant Flow|no CIS/no Loz/Emails/Full Website/Full Booklet|
155422|NCT01342523|P25|Participant Flow|No CIS/Loz/no Emails/Full Website/Full Booklet|
155423|NCT01342523|P24|Participant Flow|No CIS/Loz/Emails/Lite Website/Full Booklet|
155424|NCT01342523|P23|Participant Flow|No CIS/Loz/Emails/Full Website/Brief Booklet|
155425|NCT01342523|P22|Participant Flow|CIS/no Loz/no Email/Full Website/Full Booklet|
155426|NCT01342523|P21|Participant Flow|CIS/no Loz/Emails/Lite Website/Full Booklet|
155427|NCT01342523|P20|Participant Flow|CIS/no Loz/Emails/Full Website/Brief Booklet|
155428|NCT01342523|P19|Participant Flow|CIS/Loz/no Email/Lite Website/Full Booklet|
155429|NCT01342523|P18|Participant Flow|CIS/Loz/no Email/Full Website/Brief Booklet|
155430|NCT01342523|P17|Participant Flow|CIS/Loz/Emails/Lite Website/Brief Booklet|
155431|NCT01342523|P16|Participant Flow|no CIS/no Loz/no Email/Full Website/Full Booklet|
155432|NCT01342523|P15|Participant Flow|no CIS/no Loz/Emails/Lite Web/Full Booklet|
155433|NCT01342523|P14|Participant Flow|no CIS/no Loz/Emails/Full Website/Brief Booklet|
155434|NCT01342523|P13|Participant Flow|No CIS/Loz/No Emails/Full Website/Lite Booklet|
155435|NCT01342523|P12|Participant Flow|No CIS/Loz/No Emails/Lite Website/Full Booklet|
155436|NCT01342523|P11|Participant Flow|No CIS/Loz/Emails/Lite Website/Brief Booklet|
155437|NCT01342523|P10|Participant Flow|CIS/No Loz/no Email/Lite Website/Full Booklet|
155438|NCT01342523|P9|Participant Flow|CIS/No Loz/no Email/Full Website/Brief Booklet|
155439|NCT01342523|P8|Participant Flow|CIS/No Loz/Emails/Lite Website/Brief Booklet|
155440|NCT01342523|P7|Participant Flow|CIS/Loz/No Email/Lite Website/Brief Booklet|
155441|NCT01342523|P6|Participant Flow|No CIS/No Loz/No Email/Lite Website/Full Booklet|
155442|NCT01342523|P5|Participant Flow|No CIS/No Loz/No Email/Full Website/Brief Booklet|
155443|NCT01342523|P4|Participant Flow|No CIS/no Loz/Email/Lite Website/Brief Booklet|
155444|NCT01342523|P3|Participant Flow|no CIS/Loz/No Email/Lite Website/Brief Booklet|
155445|NCT01342523|P2|Participant Flow|CIS/No Loz/No Email/Lite Website/Brief Booklet|
155446|NCT01342523|P1|Participant Flow|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
155447|NCT01342523|O10|Outcome|Brief Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page Clearing the Air booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet."
155448|NCT01342523|O9|Outcome|Full Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received the National Cancer Institute’s 36-page Clearing the Air brochure (www.smokefree.gov/pubs/clearing_the_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet."
155449|NCT01342523|O8|Outcome|Lite SmokeFree.Gov Website|Participants in the Lite SmokeFree.gov Website intervention group received received the “Lite” version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website.
155450|NCT01342523|O7|Outcome|Full SmokeFree.Gov Website|Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
155451|NCT01342523|O6|Outcome|No Email Messaging|Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
155452|NCT01342523|O5|Outcome|Email Messaging|Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
155453|NCT01342523|O4|Outcome|No Nicotine Replacement Therapy|Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
155454|NCT01342523|O3|Outcome|Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)|Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
155519|NCT01342458|O1|Outcome|Intervention Group|Knee adduction moment (KAM) first peak
155520|NCT01342458|O2|Outcome|Control Group|Six-minute walk test
155521|NCT01342458|O1|Outcome|Intervention Group|Six-minute walk test
155455|NCT01342523|O2|Outcome|"No Cancer Information Service Counseling (No CIS)"|"Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to No CIS group and 453 to the CIS group."
155456|NCT01342523|O1|Outcome|"Cancer Information Service Counseling (CIS)"|"Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a No CIS group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the No CIS group."
155457|NCT01342523|E1|Reported Event|Lozenge|2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report.
155458|NCT01342510|B5|Baseline|Total|Total of all reporting groups
155459|NCT01342510|B4|Baseline|Control|0.9% saline in a 10 cc syringe
155460|NCT01342510|B3|Baseline|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
155461|NCT01342510|B2|Baseline|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
155462|NCT01342510|B1|Baseline|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
155463|NCT01342510|P4|Participant Flow|Control|0.9% saline in a 10 cc syringe
155464|NCT01342510|P3|Participant Flow|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
155465|NCT01342510|P2|Participant Flow|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
155466|NCT01342510|P1|Participant Flow|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
155467|NCT01342510|O4|Outcome|Control|0.9% saline in a 10 cc syringe
155468|NCT01342510|O3|Outcome|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
155469|NCT01342510|O2|Outcome|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
155470|NCT01342510|O1|Outcome|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
155471|NCT01342510|E4|Reported Event|Control|0.9% saline in a 10 cc syringe
155472|NCT01342510|E3|Reported Event|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
155473|NCT01342510|E2|Reported Event|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
155474|NCT01342510|E1|Reported Event|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
155475|NCT01342484|B4|Baseline|Total|Total of all reporting groups
155476|NCT01342484|B3|Baseline|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155477|NCT01342484|B2|Baseline|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155478|NCT01342484|B1|Baseline|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155479|NCT01342484|P3|Participant Flow|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155480|NCT01342484|P2|Participant Flow|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155481|NCT01342484|P1|Participant Flow|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155482|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155483|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155484|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155485|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155486|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155487|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155488|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155489|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155490|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155491|NCT01342484|E3|Reported Event|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
155492|NCT01342484|E2|Reported Event|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
155493|NCT01342484|E1|Reported Event|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
155494|NCT01342471|B3|Baseline|Total|Total of all reporting groups
155495|NCT01342471|B2|Baseline|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155496|NCT01342471|B1|Baseline|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155497|NCT01342471|P2|Participant Flow|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155498|NCT01342471|P1|Participant Flow|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155499|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155500|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155501|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155502|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155503|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155504|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155522|NCT01342458|O2|Outcome|Control Group|Global score of the Lequesne´s questionaire algo-functional.
155523|NCT01342458|O1|Outcome|Intervention Group|Global score of the Lequesne´s questionaire algo-functional.
155505|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155506|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155507|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155508|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155509|NCT01342471|E2|Reported Event|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155510|NCT01342471|E1|Reported Event|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
155511|NCT01342458|B3|Baseline|Total|Total of all reporting groups
155512|NCT01342458|B2|Baseline|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
155513|NCT01342458|B1|Baseline|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
155514|NCT01342458|P2|Participant Flow|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
155515|NCT01342458|P1|Participant Flow|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
155516|NCT01342458|O2|Outcome|Control Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
155517|NCT01342458|O1|Outcome|Intervention Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
155518|NCT01342458|O2|Outcome|Control Group|Knee adduction moment (KAM) first peak
155524|NCT01342458|O2|Outcome|Control Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
155525|NCT01342458|O1|Outcome|Intervention Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
155526|NCT01342458|O2|Outcome|Control Group|WOMAC Physical function subscale
155527|NCT01342458|O1|Outcome|Intervention Group|WOMAC Physical function subscale
155528|NCT01342458|O2|Outcome|Control Group|WOMAC stiffness subscale
155529|NCT01342458|O1|Outcome|Intervention Group|WOMAC stiffness subscale
155530|NCT01342458|O2|Outcome|Control Group|WOMAC pain subscale
155531|NCT01342458|O1|Outcome|Intervention Group|WOMAC pain subscale
155532|NCT01342458|E2|Reported Event|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
155533|NCT01342458|E1|Reported Event|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
155534|NCT01342445|B3|Baseline|Total|Total of all reporting groups
155535|NCT01342445|B2|Baseline|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline only and received no drug.
155536|NCT01342445|B1|Baseline|ADHD Participants|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
155537|NCT01342445|P2|Participant Flow|Attention-deficit/Hyperactivity Disorder (ADHD) Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.
155538|NCT01342445|P1|Participant Flow|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
155539|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
155540|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
155541|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
155542|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
155543|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
155544|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
155545|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
155546|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
155547|NCT01342445|E4|Reported Event|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
155548|NCT01342445|E3|Reported Event|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
155549|NCT01342445|E2|Reported Event|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
155550|NCT01342445|E1|Reported Event|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
155551|NCT01342341|B3|Baseline|Total|Total of all reporting groups
155552|NCT01342341|B2|Baseline|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155553|NCT01342341|B1|Baseline|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155554|NCT01342341|P2|Participant Flow|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155587|NCT01342081|P2|Participant Flow|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155588|NCT01342081|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155555|NCT01342341|P1|Participant Flow|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155556|NCT01342341|O2|Outcome|Placebo|"Group B Experimental: Twenty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155557|NCT01342341|O1|Outcome|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155558|NCT01342341|E2|Reported Event|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155559|NCT01342341|E1|Reported Event|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
155560|NCT01342172|B1|Baseline|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
155561|NCT01342172|P1|Participant Flow|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
155562|NCT01342172|O1|Outcome|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
155563|NCT01342172|E1|Reported Event|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
155564|NCT01342107|B3|Baseline|Total|Total of all reporting groups
155565|NCT01342107|B2|Baseline|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
155566|NCT01342107|B1|Baseline|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
155567|NCT01342107|P2|Participant Flow|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
155568|NCT01342107|P1|Participant Flow|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
155569|NCT01342107|O2|Outcome|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
155570|NCT01342107|O1|Outcome|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
155571|NCT01342107|E2|Reported Event|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
155572|NCT01342107|E1|Reported Event|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
155573|NCT01342094|B3|Baseline|Total|Total of all reporting groups
155574|NCT01342094|B2|Baseline|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
155575|NCT01342094|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155576|NCT01342094|P2|Participant Flow|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
155577|NCT01342094|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155578|NCT01342094|O2|Outcome|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
155579|NCT01342094|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155580|NCT01342094|E2|Reported Event|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
155581|NCT01342094|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155582|NCT01342081|B4|Baseline|Total|Total of all reporting groups
155583|NCT01342081|B3|Baseline|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
155584|NCT01342081|B2|Baseline|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155585|NCT01342081|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155586|NCT01342081|P3|Participant Flow|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
155589|NCT01342081|O3|Outcome|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
155590|NCT01342081|O2|Outcome|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155591|NCT01342081|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155592|NCT01342081|E3|Reported Event|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
155593|NCT01342081|E2|Reported Event|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155594|NCT01342081|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
155595|NCT01341990|B3|Baseline|Total|Total of all reporting groups
155596|NCT01341990|B2|Baseline|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155597|NCT01341990|B1|Baseline|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155598|NCT01341990|P2|Participant Flow|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155599|NCT01341990|P1|Participant Flow|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155600|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155601|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155602|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155603|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155604|NCT01341990|E2|Reported Event|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155605|NCT01341990|E1|Reported Event|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
155606|NCT01341977|B3|Baseline|Total|Total of all reporting groups
155607|NCT01341977|B2|Baseline|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
155608|NCT01341977|B1|Baseline|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
155609|NCT01341977|P2|Participant Flow|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
155610|NCT01341977|P1|Participant Flow|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
155611|NCT01341977|O2|Outcome|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
155612|NCT01341977|O1|Outcome|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
155613|NCT01341977|E2|Reported Event|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
155614|NCT01341977|E1|Reported Event|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
155615|NCT01341912|B1|Baseline|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
155616|NCT01341912|P1|Participant Flow|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
155617|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
155618|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
155619|NCT01341912|E1|Reported Event|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
155620|NCT01341782|B3|Baseline|Total|Total of all reporting groups
155621|NCT01341782|B2|Baseline|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155622|NCT01341782|B1|Baseline|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155623|NCT01341782|P2|Participant Flow|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
180801|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
155624|NCT01341782|P1|Participant Flow|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155625|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155626|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155627|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155628|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155629|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155630|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155631|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155632|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155633|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155634|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155635|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155636|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155637|NCT01341782|E2|Reported Event|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
155638|NCT01341782|E1|Reported Event|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
155639|NCT01341067|B1|Baseline|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155640|NCT01341067|P1|Participant Flow|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155641|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155642|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155643|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155644|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155645|NCT01341067|E1|Reported Event|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
155646|NCT01340937|B5|Baseline|Total|Total of all reporting groups
155647|NCT01340937|B4|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155648|NCT01340937|B3|Baseline|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155649|NCT01340937|B2|Baseline|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155650|NCT01340937|B1|Baseline|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155651|NCT01340937|P4|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155652|NCT01340937|P3|Participant Flow|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155653|NCT01340937|P2|Participant Flow|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155654|NCT01340937|P1|Participant Flow|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155655|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155656|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155657|NCT01340937|O2|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155658|NCT01340937|O1|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155659|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155660|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155661|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155662|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155663|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155664|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155665|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155666|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155667|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155668|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155669|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155670|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155671|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155672|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155673|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155674|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155831|NCT01340768|P1|Participant Flow|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
155675|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155676|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155677|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155678|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155679|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155680|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155681|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155682|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155683|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155684|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155685|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155686|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155687|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155688|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155689|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155690|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155691|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155692|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155693|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155694|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155695|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155696|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155697|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155698|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155699|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155832|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
155700|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155701|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155702|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155703|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155704|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155705|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155706|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155707|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155708|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155709|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155710|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155711|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155712|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155713|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155714|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155715|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155716|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155717|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155718|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155719|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155720|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155721|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155722|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155723|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155724|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155833|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
155725|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155726|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155727|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155728|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155729|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155730|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155731|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155732|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155733|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155734|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155735|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155736|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155737|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155738|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155739|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155740|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155741|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155742|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155743|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155744|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155745|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155746|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155747|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155748|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155749|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155834|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
155750|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155751|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155752|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155753|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155754|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155755|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155756|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155757|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155758|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155759|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155760|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155761|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155762|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155763|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155764|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155765|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155766|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155767|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155768|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155769|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155770|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155771|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155772|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155773|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155774|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155775|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155776|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155777|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155778|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155779|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155780|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155781|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155782|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155783|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155784|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155785|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155786|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155787|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155788|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155789|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155790|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155791|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155792|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155793|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155794|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155795|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155796|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155797|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155798|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155799|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155800|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155835|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
157285|NCT01335789|B2|Baseline|Saline|"intranasal administration~Saline: 40 IUs"
155801|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155802|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155803|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155804|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155805|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155806|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155807|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155808|NCT01340937|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
155809|NCT01340937|E1|Reported Event|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
155810|NCT01340794|B3|Baseline|Total|Total of all reporting groups
155811|NCT01340794|B2|Baseline|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155812|NCT01340794|B1|Baseline|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155813|NCT01340794|P2|Participant Flow|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155814|NCT01340794|P1|Participant Flow|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155815|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155816|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155817|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155818|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155819|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155820|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155821|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155822|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155823|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
155824|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155825|NCT01340794|E2|Reported Event|Treatment: Pazopanib With Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155826|NCT01340794|E1|Reported Event|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
155827|NCT01340768|B3|Baseline|Total|Total of all reporting groups
155828|NCT01340768|B2|Baseline|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
155829|NCT01340768|B1|Baseline|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
155830|NCT01340768|P2|Participant Flow|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
155836|NCT01340768|E2|Reported Event|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
155837|NCT01340768|E1|Reported Event|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
155838|NCT01340664|B4|Baseline|Total|Total of all reporting groups
155839|NCT01340664|B3|Baseline|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
155840|NCT01340664|B2|Baseline|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
155841|NCT01340664|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155842|NCT01340664|P3|Participant Flow|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
155843|NCT01340664|P2|Participant Flow|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
155844|NCT01340664|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155845|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
155846|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
155847|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155848|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
155849|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
155850|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155851|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
155852|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
155853|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155854|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
155855|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
155856|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
155857|NCT01340664|E3|Reported Event|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
155858|NCT01340664|E2|Reported Event|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
155859|NCT01340664|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 18 weeks
155860|NCT01340651|B1|Baseline|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155861|NCT01340651|P1|Participant Flow|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
155862|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
155863|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
155864|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
155865|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155866|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155867|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155868|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155869|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155870|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155871|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155872|NCT01340651|E2|Reported Event|Ruxolitinib - After Week 16|At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
155905|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155873|NCT01340651|E1|Reported Event|Ruxolitinib - Weeks 1-16|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
155874|NCT01340625|B3|Baseline|Total|Total of all reporting groups
155875|NCT01340625|B2|Baseline|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
155876|NCT01340625|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
155877|NCT01340625|P2|Participant Flow|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
155878|NCT01340625|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
155879|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155880|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155881|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155882|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155883|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155884|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155885|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155886|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155887|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155888|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155889|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
155890|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
155891|NCT01340625|E2|Reported Event|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
155892|NCT01340625|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
155893|NCT01340586|B3|Baseline|Total|Total of all reporting groups
155894|NCT01340586|B2|Baseline|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155895|NCT01340586|B1|Baseline|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155896|NCT01340586|P2|Participant Flow|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155897|NCT01340586|P1|Participant Flow|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155898|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155899|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155900|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155901|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155902|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155903|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155904|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
180802|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
155906|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155907|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155908|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155909|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155910|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155911|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155912|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155913|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155914|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155915|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155916|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155917|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155918|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155919|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155920|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155921|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155922|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155923|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155924|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155925|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155926|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155927|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155928|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155929|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155930|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155931|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155932|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155933|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155934|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155935|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155936|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
155937|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155938|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155939|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155940|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155941|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155942|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155943|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155944|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155945|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155946|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155947|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155948|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155949|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155950|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155951|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155952|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155953|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155954|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155955|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155956|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
155957|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155958|NCT01340586|E3|Reported Event|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
155959|NCT01340586|E2|Reported Event|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
155960|NCT01340586|E1|Reported Event|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
155961|NCT01340573|B1|Baseline|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
155962|NCT01340573|P1|Participant Flow|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
155963|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155964|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155965|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155966|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155967|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155968|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155969|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155970|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155971|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155972|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155973|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155974|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155975|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155976|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155977|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155978|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155979|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
155980|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
155981|NCT01340573|E1|Reported Event|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
155982|NCT01340209|B4|Baseline|Total|Total of all reporting groups
155983|NCT01340209|B3|Baseline|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155984|NCT01340209|B2|Baseline|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
155985|NCT01340209|B1|Baseline|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
155986|NCT01340209|P3|Participant Flow|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155987|NCT01340209|P2|Participant Flow|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
155988|NCT01340209|P1|Participant Flow|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
155989|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155990|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
155991|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
155992|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155993|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
155994|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
155995|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155996|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
155997|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
155998|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
155999|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156000|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156001|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156002|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156003|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156004|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156005|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156006|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156007|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156008|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156009|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156010|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156011|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156012|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156013|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156014|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156015|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156016|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156017|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156018|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156019|NCT01340209|E3|Reported Event|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
156020|NCT01340209|E2|Reported Event|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
156021|NCT01340209|E1|Reported Event|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
156022|NCT01340196|B1|Baseline|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
156023|NCT01340196|P1|Participant Flow|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
156024|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156025|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156026|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156027|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156028|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156029|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156030|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
180803|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
156031|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156032|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156033|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156034|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156035|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156036|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156037|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156038|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156039|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156040|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156041|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
156042|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156043|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156044|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
156045|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156046|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156047|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156048|NCT01340196|E3|Reported Event|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
156049|NCT01340196|E2|Reported Event|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
156050|NCT01340196|E1|Reported Event|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
156051|NCT01340144|B3|Baseline|Total|Total of all reporting groups
156052|NCT01340144|B2|Baseline|PFC Sigma HP PS TKA (Total Knee Arthoplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
156053|NCT01340144|B1|Baseline|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
156054|NCT01340144|P2|Participant Flow|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
156055|NCT01340144|P1|Participant Flow|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
156056|NCT01340144|O2|Outcome|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
156057|NCT01340144|O1|Outcome|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
156058|NCT01340144|E2|Reported Event|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
156059|NCT01340144|E1|Reported Event|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
156060|NCT01340066|B3|Baseline|Total|Total of all reporting groups
156061|NCT01340066|B2|Baseline|UISH001|At randomization at visit 2, subjects were treated with UISH001.
156062|NCT01340066|B1|Baseline|Matching Placebo|At randomization at visit 2, subjects were treated with matching placebo.
156063|NCT01340066|P3|Participant Flow|UISH001|Subjects were randomized at Visit 2
156064|NCT01340066|P2|Participant Flow|Placebo|Subjects were randomized at Visit 2
156065|NCT01340066|P1|Participant Flow|Placebo Run-In|All subjects entered a one week placebo run in period to qualify for the study.
156066|NCT01340066|O2|Outcome|UISH001|1 drop UISH001 sublingual 3 times/day
156067|NCT01340066|O1|Outcome|Placebo|1 drop Placebo sublingual 3 times/day
156068|NCT01340066|E3|Reported Event|Matching Placebo|Subjects were treated with matching placebo during double blind treatment period.
156069|NCT01340066|E2|Reported Event|UISH001|Subjects were treated with UISH001 during double blind treatment period.
156070|NCT01340066|E1|Reported Event|Non-Randomized Subjects|Adverse Events (AEs) captured for subjects that were not randomized
156071|NCT01340027|B13|Baseline|Total|Total of all reporting groups
156072|NCT01340027|B12|Baseline|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156073|NCT01340027|B11|Baseline|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156074|NCT01340027|B10|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156075|NCT01340027|B9|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156076|NCT01340027|B8|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156077|NCT01340027|B7|Baseline|Solifenacin 2.5 mg +Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156078|NCT01340027|B6|Baseline|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156079|NCT01340027|B5|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156080|NCT01340027|B4|Baseline|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156081|NCT01340027|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156082|NCT01340027|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156083|NCT01340027|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156084|NCT01340027|P12|Participant Flow|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156085|NCT01340027|P11|Participant Flow|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156086|NCT01340027|P10|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156087|NCT01340027|P9|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156088|NCT01340027|P8|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156089|NCT01340027|P7|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156090|NCT01340027|P6|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156091|NCT01340027|P5|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156092|NCT01340027|P4|Participant Flow|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156093|NCT01340027|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156094|NCT01340027|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156095|NCT01340027|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156096|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156097|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156098|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156099|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156100|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156101|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156102|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156103|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156104|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156105|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156106|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156107|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156108|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156109|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156110|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156111|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156112|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156113|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156114|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156115|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156116|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156117|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156118|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156119|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156120|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156121|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156122|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156123|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156124|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156125|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156126|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156127|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156128|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156129|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156130|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156131|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156132|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156133|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156134|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156135|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156136|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156137|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156138|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156139|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156140|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156141|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156142|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156143|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156144|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156145|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156146|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156147|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156148|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156149|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156150|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156151|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156152|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156153|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156154|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156155|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156156|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156157|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156158|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156159|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156160|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156161|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156162|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156163|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156164|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156165|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156166|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156167|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156168|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156169|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156170|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
157286|NCT01335789|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
156171|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156172|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156173|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156174|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156175|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156176|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156177|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156178|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156179|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156180|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156181|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156182|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156183|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156184|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156185|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156186|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156187|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156188|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156189|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156190|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156191|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156192|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156193|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156194|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156195|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156196|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156197|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156198|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156199|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156200|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156201|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156202|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156203|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156204|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156205|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156206|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156207|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156208|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156209|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156210|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156211|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156212|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156213|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156214|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156215|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156216|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
157287|NCT01335789|P2|Participant Flow|Saline|"intranasal administration~Saline: 40 IUs"
156217|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156218|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156219|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156220|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156221|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156222|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156223|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156224|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156225|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156226|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156227|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156228|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156229|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156230|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156231|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156232|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156233|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156234|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156235|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156236|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156237|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156238|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156239|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156240|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156241|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156242|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156243|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156244|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156245|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156246|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156247|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156248|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156249|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156250|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156251|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156252|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156253|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156254|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156255|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156256|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156257|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156258|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156259|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156260|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156261|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156262|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156263|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156264|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156265|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156266|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156267|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156268|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156269|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156270|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156271|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156272|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156273|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156274|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156275|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156276|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156277|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156278|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156279|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156280|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156281|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156282|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156283|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156284|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156285|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156286|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156287|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156288|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156289|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156290|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156291|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156292|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156293|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156294|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156295|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156296|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156297|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156298|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156299|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156300|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156301|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156302|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156303|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156304|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156305|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156306|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156307|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156308|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156309|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156310|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156311|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156312|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156313|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156314|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156315|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156316|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156317|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156318|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156319|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156320|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156321|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156322|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156323|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156324|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156325|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156326|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156327|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156328|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156329|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156330|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156331|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156332|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156333|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156334|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156335|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156336|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156337|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156338|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156339|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156340|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156341|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156342|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156343|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156344|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156345|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156346|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156347|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156348|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156349|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156350|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156351|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156352|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156353|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156354|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156355|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156356|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156357|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156358|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156359|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156360|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156361|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156362|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156363|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156364|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156365|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156366|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156367|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156368|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156369|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156370|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156371|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156372|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156373|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156374|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156375|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156376|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156377|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156378|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156379|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156380|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156381|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156382|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156383|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156384|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156385|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156386|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156387|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156388|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156389|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156390|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156391|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156392|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156393|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156394|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156395|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156396|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156397|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156398|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156399|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156400|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
180804|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
156401|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156402|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156403|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156404|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156405|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156406|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156407|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156408|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156409|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156410|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156411|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156412|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156413|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156414|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156415|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156416|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156417|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156418|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156419|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156420|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156421|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156422|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156423|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156424|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156425|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156426|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156427|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156428|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156429|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156430|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156431|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156432|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156433|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156434|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156435|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156436|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156437|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156438|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156439|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156440|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156441|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156442|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156443|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156444|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156445|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156446|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
157288|NCT01335789|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
156447|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156448|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156449|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156450|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156451|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156452|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156453|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156454|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156455|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156456|NCT01340027|E12|Reported Event|Solifenacin 10 mg and Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156457|NCT01340027|E11|Reported Event|Solifenacin 10 mg and Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156458|NCT01340027|E10|Reported Event|Solifenacin 5 mg and Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156459|NCT01340027|E9|Reported Event|Solifenacin 5 mg and Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156460|NCT01340027|E8|Reported Event|Solifenacin 2.5 mg and Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
156461|NCT01340027|E7|Reported Event|Solifenacin 2.5 mg and Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
156462|NCT01340027|E6|Reported Event|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
156463|NCT01340027|E5|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
156464|NCT01340027|E4|Reported Event|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
156465|NCT01340027|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
156466|NCT01340027|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
156467|NCT01340027|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
156468|NCT01340014|B3|Baseline|Total|Total of all reporting groups
156469|NCT01340014|B2|Baseline|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
156470|NCT01340014|B1|Baseline|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
156471|NCT01340014|P2|Participant Flow|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
156472|NCT01340014|P1|Participant Flow|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
156473|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
156474|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
156475|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
156476|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
156477|NCT01340014|E2|Reported Event|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
156478|NCT01340014|E1|Reported Event|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
156479|NCT01339936|B1|Baseline|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156480|NCT01339936|P1|Participant Flow|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156481|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156482|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156483|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156484|NCT01339936|E1|Reported Event|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
156485|NCT01339923|B8|Baseline|TOTAL|Total of all reporting groups
156486|NCT01339923|B7|Baseline|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
156690|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
156487|NCT01339923|B6|Baseline|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
156488|NCT01339923|B5|Baseline|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156489|NCT01339923|B4|Baseline|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156490|NCT01339923|B3|Baseline|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
156491|NCT01339923|B2|Baseline|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
156492|NCT01339923|B1|Baseline|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
156493|NCT01339923|P7|Participant Flow|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
156494|NCT01339923|P6|Participant Flow|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
156495|NCT01339923|P5|Participant Flow|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156496|NCT01339923|P4|Participant Flow|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156497|NCT01339923|P3|Participant Flow|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
156498|NCT01339923|P2|Participant Flow|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
156499|NCT01339923|P1|Participant Flow|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
156500|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156501|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156502|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156503|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156504|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156505|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156506|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156507|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156508|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156509|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156907|NCT01337635|B1|Baseline|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156510|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156511|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156512|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156513|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156514|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156515|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156516|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156517|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156518|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156519|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156520|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156521|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156522|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156523|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156524|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156525|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 ad 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156526|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5 12 rMenB + OMV vaccine"
156527|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156953|NCT01337336|E1|Reported Event|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156528|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156529|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
156530|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
156531|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156532|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156533|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156534|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156535|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156536|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
156537|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156538|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156539|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
156540|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156541|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156542|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156543|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156544|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156545|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
156546|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156547|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156548|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
156954|NCT01337297|B3|Baseline|Total|Total of all reporting groups
157289|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
156549|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156550|NCT01339923|O4|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156551|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
156552|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
156553|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
156554|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156555|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
156556|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)"
156557|NCT01339923|O2|Outcome|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
156558|NCT01339923|O1|Outcome|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
156559|NCT01339923|E8|Reported Event|TOTAL|All subjects in the safety population.
156560|NCT01339923|E7|Reported Event|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
156561|NCT01339923|E6|Reported Event|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
156562|NCT01339923|E5|Reported Event|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156563|NCT01339923|E4|Reported Event|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
156564|NCT01339923|E3|Reported Event|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
156565|NCT01339923|E2|Reported Event|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
156566|NCT01339923|E1|Reported Event|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
156567|NCT01339897|B5|Baseline|Total|Total of all reporting groups
156568|NCT01339897|B4|Baseline|Placebo|Non-Active
156569|NCT01339897|B3|Baseline|Cohort 3|N6022 - Active 20 mg
156570|NCT01339897|B2|Baseline|Cohort 2|N6022 - Active 10 mg
156571|NCT01339897|B1|Baseline|Cohort 1|N6022 - Active 5 mg
156572|NCT01339897|P4|Participant Flow|20 mg/N6022|Active Group- 20 mg by IV administration (5 mg/minute)
156573|NCT01339897|P3|Participant Flow|10 mg/N6022|Active Group- 10 mg by IV administration (5 mg/minute)
156574|NCT01339897|P2|Participant Flow|Placebo|Non-Active
156575|NCT01339897|P1|Participant Flow|5 mg/N6022|Active Group- 5 mg by IV administration (5 mg/minute)
156576|NCT01339897|O4|Outcome|Placebo|Non-Active
156577|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
156578|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
156579|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
156580|NCT01339897|O4|Outcome|Placebo|Non-Active
156581|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
156582|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
156583|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
156584|NCT01339897|O4|Outcome|Placebo|Non-Active
156585|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
156586|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
156587|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
156588|NCT01339897|O4|Outcome|Placebo|Non-Active
156589|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
156590|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
156591|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
156592|NCT01339897|O4|Outcome|Placebo|Non-Active
156593|NCT01339897|O3|Outcome|Cohort 3|N6022 - Active 20 mg
156594|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
156595|NCT01339897|O1|Outcome|Cohort 1|N6022 - Active 5 mg
156596|NCT01339897|E4|Reported Event|Placebo|Non-Active
156597|NCT01339897|E3|Reported Event|Cohort 3|N6022 - Active 20 mg
156598|NCT01339897|E2|Reported Event|Cohort 2|N6022 Active - 10 mg
156599|NCT01339897|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
156600|NCT01339832|B1|Baseline|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156601|NCT01339832|P1|Participant Flow|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156602|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156603|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156604|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156605|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156606|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156607|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156608|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156609|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156610|NCT01339832|E1|Reported Event|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
156611|NCT01339429|B1|Baseline|Simplified Negative Pressure Wound Therapy|"The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.~simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours."
156612|NCT01339429|P1|Participant Flow|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube."
156613|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
156614|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
156615|NCT01339429|E1|Reported Event|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
156616|NCT01339416|B1|Baseline|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156617|NCT01339416|P1|Participant Flow|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156618|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156619|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156620|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156621|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156622|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156623|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
157290|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
156624|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156625|NCT01339416|E1|Reported Event|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
156626|NCT01339403|B3|Baseline|Total|Total of all reporting groups
156627|NCT01339403|B2|Baseline|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156628|NCT01339403|B1|Baseline|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156629|NCT01339403|P2|Participant Flow|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156630|NCT01339403|P1|Participant Flow|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156631|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156632|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156633|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156634|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156635|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156636|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156637|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156638|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156639|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156640|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156641|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156642|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156643|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156644|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156645|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156646|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156647|NCT01339403|E2|Reported Event|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156648|NCT01339403|E1|Reported Event|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
156649|NCT01339390|B3|Baseline|Total|Total of all reporting groups
156650|NCT01339390|B2|Baseline|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
156651|NCT01339390|B1|Baseline|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
156652|NCT01339390|P2|Participant Flow|Arm 2: MOVE!|"As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
156653|NCT01339390|P1|Participant Flow|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
156654|NCT01339390|O2|Outcome|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
156655|NCT01339390|O1|Outcome|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
156656|NCT01339390|E2|Reported Event|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
156657|NCT01339390|E1|Reported Event|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
156658|NCT01339299|B3|Baseline|Total|Total of all reporting groups
156659|NCT01339299|B2|Baseline|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156660|NCT01339299|B1|Baseline|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156661|NCT01339299|P2|Participant Flow|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
157291|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
156662|NCT01339299|P1|Participant Flow|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156663|NCT01339299|O2|Outcome|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156664|NCT01339299|O1|Outcome|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156665|NCT01339299|E2|Reported Event|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156666|NCT01339299|E1|Reported Event|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
156667|NCT01339260|B3|Baseline|Total|Total of all reporting groups
156668|NCT01339260|B2|Baseline|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
156669|NCT01339260|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
156670|NCT01339260|P2|Participant Flow|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
156671|NCT01339260|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
156672|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
156673|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
156674|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
156675|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
156676|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
156677|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
156678|NCT01339260|E4|Reported Event|Palonosetron+Dexamethasone-multicycle Extension|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
156679|NCT01339260|E3|Reported Event|Netupitant and Palonosetron+Dexamethasone-multicycle Extension|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
156680|NCT01339260|E2|Reported Event|Palonosetron+Dexamethasone-cycle 1|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
156681|NCT01339260|E1|Reported Event|Netupitant and Palonosetron+Dexamethasone-cycle 1|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
156682|NCT01339247|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga – Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
156683|NCT01339247|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
156684|NCT01339247|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
156685|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
156686|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
156687|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
156688|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
156689|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
180805|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
156691|NCT01339247|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
156692|NCT01339247|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
156693|NCT01339091|B3|Baseline|Total|Total of all reporting groups
156694|NCT01339091|B2|Baseline|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156695|NCT01339091|B1|Baseline|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156696|NCT01339091|P2|Participant Flow|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156697|NCT01339091|P1|Participant Flow|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156698|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156699|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156700|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156701|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156702|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156703|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156704|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156705|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156706|NCT01339091|E2|Reported Event|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
156707|NCT01339091|E1|Reported Event|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
156708|NCT01339013|B1|Baseline|All Study Participants|Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger
156709|NCT01339013|P1|Participant Flow|AnaConDa Replaces the Heat and Moisture Exchanger|The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.
156710|NCT01339013|O1|Outcome|AnaConDa|Anesthetic Conserving Device (AnaConDa) has a charcoal filter.
156711|NCT01339013|E1|Reported Event|AnaConDa|Anesthetic Conserving Device (AnaConDa or ACD) has a charcoal filter.
156712|NCT01339000|B3|Baseline|Total|Total of all reporting groups
156713|NCT01339000|B2|Baseline|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156714|NCT01339000|B1|Baseline|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156715|NCT01339000|P2|Participant Flow|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156716|NCT01339000|P1|Participant Flow|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
157272|NCT01335997|E1|Reported Event|Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
156717|NCT01339000|O2|Outcome|Arm B - Sequence Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156718|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156719|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156720|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizationa|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156721|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156722|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156723|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156724|NCT01339000|O1|Outcome|Arm A -Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156725|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156726|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156727|NCT01339000|E2|Reported Event|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156728|NCT01339000|E1|Reported Event|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
156729|NCT01338870|B7|Baseline|Total|Total of all reporting groups
156730|NCT01338870|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156731|NCT01338870|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156732|NCT01338870|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156733|NCT01338870|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156734|NCT01338870|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156735|NCT01338870|B1|Baseline|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156736|NCT01338870|P6|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156737|NCT01338870|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156738|NCT01338870|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156739|NCT01338870|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156740|NCT01338870|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156741|NCT01338870|P1|Participant Flow|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156742|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156743|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156744|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156745|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156746|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156747|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156748|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156749|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156750|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156751|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156752|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156753|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156754|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156755|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156756|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156757|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156758|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156759|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156760|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156761|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156762|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156763|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156764|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156765|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156766|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156767|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156768|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156769|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156770|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156771|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157074|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
156772|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156773|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156774|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156775|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156776|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156777|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156778|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156779|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156780|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156781|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156782|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156783|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156784|NCT01338870|E6|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156785|NCT01338870|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156786|NCT01338870|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156787|NCT01338870|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156788|NCT01338870|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156789|NCT01338870|E1|Reported Event|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
156790|NCT01338857|B1|Baseline|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
156791|NCT01338857|P1|Participant Flow|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
156792|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
156828|NCT01338493|B1|Baseline|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
156793|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
156794|NCT01338857|E1|Reported Event|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
156795|NCT01338818|B1|Baseline|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156796|NCT01338818|P1|Participant Flow|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156797|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156798|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156799|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156800|NCT01338818|E1|Reported Event|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
156801|NCT01338792|B1|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156802|NCT01338792|P1|Participant Flow|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156803|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156804|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156805|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156806|NCT01338792|E1|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
156807|NCT01338649|B3|Baseline|Total|Total of all reporting groups
156808|NCT01338649|B2|Baseline|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
156809|NCT01338649|B1|Baseline|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
156810|NCT01338649|P2|Participant Flow|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
156811|NCT01338649|P1|Participant Flow|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
156812|NCT01338649|O2|Outcome|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
156813|NCT01338649|O1|Outcome|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
156814|NCT01338649|E2|Reported Event|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
156815|NCT01338649|E1|Reported Event|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
156816|NCT01338610|B4|Baseline|Total|Total of all reporting groups
156817|NCT01338610|B3|Baseline|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
156818|NCT01338610|B2|Baseline|ESBA105|ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
156819|NCT01338610|B1|Baseline|Run-In Only|ESBA105 vehicle
156820|NCT01338610|P3|Participant Flow|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
156821|NCT01338610|P2|Participant Flow|ESBA105|ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
156822|NCT01338610|P1|Participant Flow|Run-In Only|ESBA105 vehicle
156823|NCT01338610|O2|Outcome|Vehicle|ESBA105 vehicle
156824|NCT01338610|O1|Outcome|ESBA105|ESBA105 ophthalmic solution
156825|NCT01338610|E3|Reported Event|Vehicle|ESBA105 vehicle
156826|NCT01338610|E2|Reported Event|ESBA105|ESBA105 ophthalmic solution
156827|NCT01338610|E1|Reported Event|Run-In|ESBA105 vehicle, all participants
157273|NCT01335867|B3|Baseline|Total|Total of all reporting groups
156829|NCT01338493|P1|Participant Flow|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
156830|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
156831|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
156832|NCT01338493|E1|Reported Event|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
156833|NCT01338025|B3|Baseline|Total|Total of all reporting groups
156834|NCT01338025|B2|Baseline|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
156835|NCT01338025|B1|Baseline|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
156836|NCT01338025|P2|Participant Flow|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)"
156837|NCT01338025|P1|Participant Flow|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider."
156838|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
156839|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
156840|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
156841|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
156842|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
156843|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
156844|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
156845|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
157274|NCT01335867|B2|Baseline|Placebo|Placebo: Placebo pills
156846|NCT01338025|E2|Reported Event|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
156847|NCT01338025|E1|Reported Event|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
156848|NCT01337960|B4|Baseline|Total|Total of all reporting groups
156849|NCT01337960|B3|Baseline|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156850|NCT01337960|B2|Baseline|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156851|NCT01337960|B1|Baseline|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156852|NCT01337960|P3|Participant Flow|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156853|NCT01337960|P2|Participant Flow|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156854|NCT01337960|P1|Participant Flow|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156855|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156902|NCT01337674|E3|Reported Event|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
157076|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
156856|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156857|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156858|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156859|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156860|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156861|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156862|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156863|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156903|NCT01337674|E2|Reported Event|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156904|NCT01337674|E1|Reported Event|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156864|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156865|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156866|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156867|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156868|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156869|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156870|NCT01337960|E3|Reported Event|Trll Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
156871|NCT01337960|E2|Reported Event|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156905|NCT01337635|B3|Baseline|Total|Total of all reporting groups
156906|NCT01337635|B2|Baseline|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156872|NCT01337960|E1|Reported Event|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
156873|NCT01337739|B3|Baseline|Total|Total of all reporting groups
156874|NCT01337739|B2|Baseline|Active Comparator|Administration of Dexmedetomidine
156875|NCT01337739|B1|Baseline|Placebo Comparator|Continuous infusion of placebo during operative procedure
156876|NCT01337739|P2|Participant Flow|Active Comparator|Administration of Dexmedetomidine
156877|NCT01337739|P1|Participant Flow|Placebo Comparator|Continuous infusion of placebo during operative procedure
156878|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
156879|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
156880|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
156881|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
156882|NCT01337739|E2|Reported Event|Active Comparator|Administration of Dexmedetomidine
156883|NCT01337739|E1|Reported Event|Placebo Comparator|Continuous infusion of placebo during operative procedure
156884|NCT01337674|B3|Baseline|Total|Total of all reporting groups
156885|NCT01337674|B2|Baseline|Panel B Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156886|NCT01337674|B1|Baseline|Panel A Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156887|NCT01337674|P4|Participant Flow|Panel B: PBO + Amlo → MK-4618 + Amlo|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
156888|NCT01337674|P3|Participant Flow|Panel B: MK-4618 + Amlo → PBO + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
156889|NCT01337674|P2|Participant Flow|Panel A: PBO + Met → MK-4618 + Met|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
156890|NCT01337674|P1|Participant Flow|Panel A: MK-4618 + Met → PBO + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
156891|NCT01337674|O2|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156892|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156893|NCT01337674|O2|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156894|NCT01337674|O1|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156895|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156896|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156897|NCT01337674|O4|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156898|NCT01337674|O3|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
156899|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156900|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
156901|NCT01337674|E4|Reported Event|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
157275|NCT01335867|B1|Baseline|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
156908|NCT01337635|P2|Participant Flow|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156909|NCT01337635|P1|Participant Flow|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156910|NCT01337635|O2|Outcome|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156911|NCT01337635|O1|Outcome|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156912|NCT01337635|E2|Reported Event|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156913|NCT01337635|E1|Reported Event|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
156914|NCT01337609|B4|Baseline|Total|Total of all reporting groups
156915|NCT01337609|B3|Baseline|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156916|NCT01337609|B2|Baseline|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156917|NCT01337609|B1|Baseline|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156918|NCT01337609|P3|Participant Flow|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156919|NCT01337609|P2|Participant Flow|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156920|NCT01337609|P1|Participant Flow|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156921|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156922|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156923|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156924|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156925|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156926|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156927|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156928|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156929|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156930|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156931|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156932|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156933|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
156934|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
156935|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
156936|NCT01337609|E3|Reported Event|Placebo for 30 Days, Followed by GanedenBC30 for 30 Days|
156937|NCT01337609|E2|Reported Event|GanedenBC30 for 60 Days|
156938|NCT01337609|E1|Reported Event|Placebo for 60 Days|
156939|NCT01337336|B3|Baseline|Total|Total of all reporting groups
156940|NCT01337336|B2|Baseline|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156941|NCT01337336|B1|Baseline|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156942|NCT01337336|P2|Participant Flow|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156943|NCT01337336|P1|Participant Flow|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156944|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156945|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156946|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156947|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156948|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156949|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156950|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156951|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
156952|NCT01337336|E2|Reported Event|AC Cohort|Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
156955|NCT01337297|B2|Baseline|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156956|NCT01337297|B1|Baseline|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156957|NCT01337297|P2|Participant Flow|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156958|NCT01337297|P1|Participant Flow|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156959|NCT01337297|O2|Outcome|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156960|NCT01337297|O1|Outcome|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156961|NCT01337297|E2|Reported Event|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156962|NCT01337297|E1|Reported Event|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
156963|NCT01337167|B3|Baseline|Total|Total of all reporting groups
156964|NCT01337167|B2|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156965|NCT01337167|B1|Baseline|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156966|NCT01337167|P2|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156967|NCT01337167|P1|Participant Flow|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156968|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156969|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156970|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156971|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156972|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157276|NCT01335867|P2|Participant Flow|Placebo|Placebo: Placebo pills
156973|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156974|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156975|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156976|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156977|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156978|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156979|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156980|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156981|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156982|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156983|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156984|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156985|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156986|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156987|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156988|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156989|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156990|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156991|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156992|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156993|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156994|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157277|NCT01335867|P1|Participant Flow|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
157278|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
156995|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156996|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156997|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156998|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
156999|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157000|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157001|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157002|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157003|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157004|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157005|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157006|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157007|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157008|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157009|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157010|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157011|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157012|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157013|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157014|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157015|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157016|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157279|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
157280|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
157017|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157018|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157019|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157020|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157021|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157022|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157023|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157024|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157025|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157026|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157027|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157028|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157029|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157030|NCT01337167|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157031|NCT01337167|E1|Reported Event|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
157032|NCT01337115|B3|Baseline|Total|Total of all reporting groups
157033|NCT01337115|B2|Baseline|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157034|NCT01337115|B1|Baseline|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157035|NCT01337115|P2|Participant Flow|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157036|NCT01337115|P1|Participant Flow|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157037|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157038|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157039|NCT01337115|O2|Outcome|CFNB+Single Shot SNB|Patients with additional sciatic nerve block
157040|NCT01337115|O1|Outcome|CFNB|Patients with continuous femoral nerve block
157041|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157075|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157042|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157043|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157044|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157045|NCT01337115|E2|Reported Event|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
157046|NCT01337115|E1|Reported Event|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
157047|NCT01337076|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
157048|NCT01337076|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
157049|NCT01337076|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
157050|NCT01337076|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
157051|NCT01337050|B4|Baseline|Total|Total of all reporting groups
157052|NCT01337050|B3|Baseline|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157053|NCT01337050|B2|Baseline|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157054|NCT01337050|B1|Baseline|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157055|NCT01337050|P3|Participant Flow|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157056|NCT01337050|P2|Participant Flow|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157057|NCT01337050|P1|Participant Flow|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157058|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157059|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157060|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157061|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157062|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157063|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157064|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157065|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157066|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157067|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157068|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157069|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157070|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157071|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157072|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157073|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157077|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157078|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157079|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157080|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157081|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157082|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157083|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157084|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157085|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157086|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157087|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157088|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157089|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157090|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157091|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157092|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157093|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157094|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157095|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157096|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157097|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157098|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157099|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157100|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157101|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157102|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157103|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157104|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157105|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157106|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157107|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
180806|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
157108|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157109|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157110|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157111|NCT01337050|E3|Reported Event|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157112|NCT01337050|E2|Reported Event|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157113|NCT01337050|E1|Reported Event|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
157114|NCT01336738|B6|Baseline|Total|Total of all reporting groups
157115|NCT01336738|B5|Baseline|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157116|NCT01336738|B4|Baseline|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157117|NCT01336738|B3|Baseline|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157118|NCT01336738|B2|Baseline|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157119|NCT01336738|B1|Baseline|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157120|NCT01336738|P5|Participant Flow|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157121|NCT01336738|P4|Participant Flow|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157122|NCT01336738|P3|Participant Flow|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157123|NCT01336738|P2|Participant Flow|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157124|NCT01336738|P1|Participant Flow|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157125|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157126|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157127|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157128|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157129|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157130|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157281|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
157282|NCT01335867|E2|Reported Event|Placebo|Placebo: Placebo pills
157131|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157132|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157133|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157134|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157135|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157136|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157137|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157138|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157139|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157140|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157141|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157142|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157143|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157144|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157145|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157146|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157147|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157148|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157149|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157150|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157228|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157151|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157152|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157153|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157154|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157155|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157156|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157157|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157158|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157159|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157160|NCT01336738|E5|Reported Event|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157161|NCT01336738|E4|Reported Event|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157162|NCT01336738|E3|Reported Event|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157163|NCT01336738|E2|Reported Event|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157164|NCT01336738|E1|Reported Event|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
157165|NCT01336712|B1|Baseline|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157166|NCT01336712|P1|Participant Flow|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4~Patient follow up x6 months"
157167|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157168|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157169|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157170|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157292|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
157171|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157172|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157173|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157174|NCT01336712|E1|Reported Event|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
157175|NCT01336647|B4|Baseline|Total|Total of all reporting groups
157176|NCT01336647|B3|Baseline|Vehicle|Vehicle Gel without active ingredient of Ha44.
157177|NCT01336647|B2|Baseline|High-Dose Ha44|High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes
157178|NCT01336647|B1|Baseline|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes
157179|NCT01336647|P3|Participant Flow|Vehicle|Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
157180|NCT01336647|P2|Participant Flow|High-Dose Ha44|High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose
157181|NCT01336647|P1|Participant Flow|Low Dose Ha 44 Gel|Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.
157182|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
157183|NCT01336647|O2|Outcome|High Dose Ha44|High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
157184|NCT01336647|O1|Outcome|Low Dose Ha44|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
157185|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
157186|NCT01336647|O2|Outcome|Hig Dose Ha44|Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
157187|NCT01336647|O1|Outcome|Low Dose Ha44|Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
157188|NCT01336647|E3|Reported Event|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
157189|NCT01336647|E2|Reported Event|High Dose Ha44 Gel|High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.
157190|NCT01336647|E1|Reported Event|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
157191|NCT01336608|B4|Baseline|Total|Total of all reporting groups
157192|NCT01336608|B3|Baseline|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157193|NCT01336608|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157194|NCT01336608|B1|Baseline|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157195|NCT01336608|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157196|NCT01336608|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157197|NCT01336608|P2|Participant Flow|Placebo QD|Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157198|NCT01336608|P1|Participant Flow|Placebo-Run-in|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
157199|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157200|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157201|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157271|NCT01335997|E2|Reported Event|Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
157202|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157203|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157204|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157205|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157206|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157207|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157208|NCT01336608|E3|Reported Event|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157209|NCT01336608|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157210|NCT01336608|E1|Reported Event|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
157211|NCT01336569|B1|Baseline|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
157212|NCT01336569|P1|Participant Flow|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
157213|NCT01336569|O1|Outcome|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
157214|NCT01336569|E1|Reported Event|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
157215|NCT01336296|B3|Baseline|Total|Total of all reporting groups
157216|NCT01336296|B2|Baseline|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157217|NCT01336296|B1|Baseline|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157218|NCT01336296|P2|Participant Flow|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157219|NCT01336296|P1|Participant Flow|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157220|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157221|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157222|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157223|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157224|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157225|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157226|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157227|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157229|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157230|NCT01336296|E2|Reported Event|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157231|NCT01336296|E1|Reported Event|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
157232|NCT01336205|B3|Baseline|Total|Total of all reporting groups
157233|NCT01336205|B2|Baseline|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
157234|NCT01336205|B1|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
157235|NCT01336205|P2|Participant Flow|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
157236|NCT01336205|P1|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
157237|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
157238|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
157239|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
157240|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
157241|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
157242|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
157243|NCT01336205|E2|Reported Event|Usual Care|
157244|NCT01336205|E1|Reported Event|NKTR-118 25 mg|
157245|NCT01336140|B3|Baseline|Total|Total of all reporting groups
157246|NCT01336140|B2|Baseline|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157247|NCT01336140|B1|Baseline|Aminophylline|75 mg of intravenous aminophylline.
157248|NCT01336140|P2|Participant Flow|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157249|NCT01336140|P1|Participant Flow|Aminophylline|75 mg of intravenous aminophylline.
157250|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157251|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
157252|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157253|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
157254|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157255|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
157256|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157257|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
157258|NCT01336140|E2|Reported Event|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
157259|NCT01336140|E1|Reported Event|Aminophylline|75 mg of intravenous aminophylline.
157260|NCT01335997|B3|Baseline|Total|Total of all reporting groups
157261|NCT01335997|B2|Baseline|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
157262|NCT01335997|B1|Baseline|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
157263|NCT01335997|P2|Participant Flow|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
157264|NCT01335997|P1|Participant Flow|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
157265|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
157266|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
157267|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
157268|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
157269|NCT01335997|E4|Reported Event|Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
157270|NCT01335997|E3|Reported Event|Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
157283|NCT01335867|E1|Reported Event|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
157293|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
157294|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
157295|NCT01335789|E2|Reported Event|Saline|"intranasal administration~Saline: 40 IUs"
157296|NCT01335789|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
157297|NCT01335750|B1|Baseline|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
157298|NCT01335750|P1|Participant Flow|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
157299|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
157300|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
157301|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
157302|NCT01335750|O1|Outcome|Multipurpose Solution #1|Optifree Replenish
157303|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline solution
157304|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
157305|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
157306|NCT01335750|O1|Outcome|Mutlipurpose Solution #1|Optifree Replenish Multipurpose Solution
157307|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
157308|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
157309|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
157310|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
157311|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Multipurpose Solution
157312|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
157313|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
157314|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
157315|NCT01335750|E1|Reported Event|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
157316|NCT01335724|B3|Baseline|Total|Total of all reporting groups
157317|NCT01335724|B2|Baseline|Placebo Gel|
157318|NCT01335724|B1|Baseline|Diclofenac Diethylamine 1.16% Gel|
157319|NCT01335724|P2|Participant Flow|Placebo Gel|
157320|NCT01335724|P1|Participant Flow|Diclofenac Diethylamine 1.16% Gel|
157321|NCT01335724|O2|Outcome|Placebo Gel|
157322|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
157323|NCT01335724|O2|Outcome|Placebo Gel|
157324|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
157325|NCT01335724|O2|Outcome|Placebo Gel|
157326|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
157327|NCT01335724|E2|Reported Event|Placebo Gel|
157328|NCT01335724|E1|Reported Event|Diclofenac Diethylamine 1.16% Gel|
157329|NCT01335698|B6|Baseline|Total|Total of all reporting groups
157330|NCT01335698|B5|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157331|NCT01335698|B4|Baseline|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157332|NCT01335698|B3|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157333|NCT01335698|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157334|NCT01335698|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157335|NCT01335698|P5|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157424|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157336|NCT01335698|P4|Participant Flow|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157337|NCT01335698|P3|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157338|NCT01335698|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157339|NCT01335698|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157340|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157341|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157342|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157343|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157344|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157345|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157346|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157347|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157348|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157558|NCT01335061|O1|Outcome|All Population|The data for all the participants is presented.
157349|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157350|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157351|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157352|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157353|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157354|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157355|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157356|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157357|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157358|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157359|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157360|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets,100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157361|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157701|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157362|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157363|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157364|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157365|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157366|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157367|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157368|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157369|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157370|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157371|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157372|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157373|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157374|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157617|NCT01334918|O5|Outcome|MDCT: Reviewer 2|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
157375|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157376|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157377|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157378|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157379|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157380|NCT01335698|E5|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157381|NCT01335698|E4|Reported Event|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157382|NCT01335698|E3|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157383|NCT01335698|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157384|NCT01335698|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
157385|NCT01335542|B3|Baseline|Total|Total of all reporting groups
157386|NCT01335542|B2|Baseline|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
157387|NCT01335542|B1|Baseline|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
157388|NCT01335542|P2|Participant Flow|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
157423|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157696|NCT01334229|B3|Baseline|Total|Total of all reporting groups
157389|NCT01335542|P1|Participant Flow|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
157390|NCT01335542|O2|Outcome|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
157391|NCT01335542|O1|Outcome|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
157392|NCT01335542|E2|Reported Event|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
157393|NCT01335542|E1|Reported Event|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
157394|NCT01335477|B3|Baseline|Total|Total of all reporting groups
157395|NCT01335477|B2|Baseline|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157396|NCT01335477|B1|Baseline|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157397|NCT01335477|P2|Participant Flow|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157398|NCT01335477|P1|Participant Flow|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157399|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157400|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157401|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157402|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157403|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157404|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157405|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157406|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157407|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157408|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157409|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157410|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157411|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157412|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157413|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157414|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157415|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157416|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157417|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157418|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157419|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157420|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157421|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157422|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157425|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157426|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157427|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157428|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157429|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157430|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157431|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157432|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157433|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157434|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157435|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157436|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157437|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157438|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157439|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157440|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157441|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157442|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157443|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157444|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157445|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157446|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157447|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157448|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157449|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157450|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157451|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157452|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157453|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157454|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157455|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157456|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
157457|NCT01335477|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
157458|NCT01335477|E1|Reported Event|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules.
157459|NCT01335464|B3|Baseline|Total|Total of all reporting groups
157460|NCT01335464|B2|Baseline|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157461|NCT01335464|B1|Baseline|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157462|NCT01335464|P2|Participant Flow|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157463|NCT01335464|P1|Participant Flow|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157464|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157465|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157466|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157467|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157468|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157469|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157470|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157471|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157472|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157473|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157474|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157475|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157476|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157477|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157478|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157479|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157480|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157481|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157482|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157483|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157484|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157485|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157486|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157487|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157488|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157489|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157490|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157491|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157492|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157493|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157494|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157495|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157496|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157497|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157498|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157499|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157500|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157501|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157502|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157503|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157504|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157505|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157702|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157506|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157507|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157508|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157509|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157510|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157511|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157512|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157513|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157514|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157515|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157516|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157517|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157518|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157519|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157520|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
157521|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
157522|NCT01335464|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
157523|NCT01335464|E1|Reported Event|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules.
157524|NCT01335230|B5|Baseline|Total|Total of all reporting groups
157525|NCT01335230|B4|Baseline|10 Control Subjects|10 subjects without HIV, HCV, or both
157526|NCT01335230|B3|Baseline|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
157527|NCT01335230|B2|Baseline|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
157528|NCT01335230|B1|Baseline|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
157529|NCT01335230|P4|Participant Flow|10 Control Subjects|10 subjects without HIV, HCV, or both
157530|NCT01335230|P3|Participant Flow|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
157531|NCT01335230|P2|Participant Flow|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
157532|NCT01335230|P1|Participant Flow|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
157533|NCT01335230|O4|Outcome|10 Control Subjects|10 subjects without HIV, HCV, or both
157534|NCT01335230|O3|Outcome|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
157535|NCT01335230|O2|Outcome|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
157536|NCT01335230|O1|Outcome|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
157537|NCT01335230|E4|Reported Event|10 Control Subjects|10 subjects without HIV, HCV, or both
157538|NCT01335230|E3|Reported Event|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
157539|NCT01335230|E2|Reported Event|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
157540|NCT01335230|E1|Reported Event|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
157541|NCT01335191|B3|Baseline|Total|Total of all reporting groups
157542|NCT01335191|B2|Baseline|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
157543|NCT01335191|B1|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
157544|NCT01335191|P2|Participant Flow|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
157545|NCT01335191|P1|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
157546|NCT01335191|O2|Outcome|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
157547|NCT01335191|O1|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
157548|NCT01335191|E2|Reported Event|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
157549|NCT01335191|E1|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
157550|NCT01335061|B1|Baseline|All Participants|The data for all the participants is presented.
157551|NCT01335061|P1|Participant Flow|All Participants|The data for all the participants is presented.
157552|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
157553|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
157554|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157555|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
157556|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157557|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
157559|NCT01335061|O2|Outcome|On-Demand Therapy-Follow-up Infusions|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157560|NCT01335061|O1|Outcome|On-Demand Therapy-First Infusion|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157561|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100 IU/kg once weekly was initiated at Visit 4.
157562|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157563|NCT01335061|E2|Reported Event|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
157564|NCT01335061|E1|Reported Event|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
157565|NCT01334957|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157566|NCT01334957|P1|Participant Flow|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157567|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157568|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157569|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157570|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157571|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157572|NCT01334957|E1|Reported Event|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157573|NCT01334944|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.~Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
157574|NCT01334944|P2|Participant Flow|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157575|NCT01334944|P1|Participant Flow|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157576|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157577|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157578|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157579|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157580|NCT01334944|O1|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157581|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157582|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157583|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157584|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157703|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157585|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157586|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157587|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157588|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157589|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157590|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157591|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157592|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157593|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
157594|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157595|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157596|NCT01334944|E2|Reported Event|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
157597|NCT01334944|E1|Reported Event|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
157598|NCT01334918|B3|Baseline|Total|Total of all reporting groups
157599|NCT01334918|B2|Baseline|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
157600|NCT01334918|B1|Baseline|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
157601|NCT01334918|P2|Participant Flow|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
157602|NCT01334918|P1|Participant Flow|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
157603|NCT01334918|O1|Outcome|SPECT + MDCT|Participants underwent both a rest and stress SPECT series and a rest and stress MDCT series.
157604|NCT01334918|O3|Outcome|CTP: All Fixed Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
157605|NCT01334918|O2|Outcome|CTP: ≥ 1 Fixed Defects|Participants with ≥ 1 fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157606|NCT01334918|O1|Outcome|CTP: 0 Fixed Defects|Participants with zero fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157607|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
157608|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157609|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157610|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
157611|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157612|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157613|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
157614|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157615|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157616|NCT01334918|O6|Outcome|MDCT: Reviewer 3|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
157618|NCT01334918|O4|Outcome|MDCT: Reviewer 1|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
157619|NCT01334918|O3|Outcome|SPECT: Reviewer 3|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 3.
157620|NCT01334918|O2|Outcome|SPECT: Reviewer 2|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 2.
157621|NCT01334918|O1|Outcome|SPECT: Reviewer 1|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 1.
157622|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
157623|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157624|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
157625|NCT01334918|E2|Reported Event|MDCT|Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
157626|NCT01334918|E1|Reported Event|SPECT|Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
157627|NCT01334866|B1|Baseline|Study Completion Cohort|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
157628|NCT01334866|P1|Participant Flow|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
157629|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
157630|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
157631|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
157632|NCT01334866|O1|Outcome|Study Procedure Cohort|89 Subjects received study treatment
157633|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
157634|NCT01334866|E1|Reported Event|Study Procedure Cohort|89 Subjects received study treatment
157635|NCT01334723|B3|Baseline|Total|Total of all reporting groups
157636|NCT01334723|B2|Baseline|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157637|NCT01334723|B1|Baseline|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157638|NCT01334723|P2|Participant Flow|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157639|NCT01334723|P1|Participant Flow|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157640|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157641|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157642|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157643|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157644|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157645|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157646|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157647|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157648|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157649|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157650|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >80%|Participants in the prostate surgery outcomes cohort with an MPR >80%
157651|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=80%|Participants in the prostate surgery outcomes cohort with an MPR <=80%
157652|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >80%|Participants in the acute urinary retention outcomes cohort with an >80%
157653|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=80%|Participants in the acute urinary retention outcomes cohort with an MPR <=80%
157654|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >75%|Participants in the prostate surgery outcomes cohort with an MPR >75%
157655|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=75%|Participants in the prostate surgery outcomes cohort with an MPR <=75%
157656|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >75%|Participants in the acute urinary retention outcomes cohort with an MPR >75%
157657|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=75%|Among the Participants in the acute urinary retention outcomes cohort with an MPR <=75%
157658|NCT01334723|O4|Outcome|Prostate Surgery Outocomes Cohort, MPR >70%|Participants in the prostate surgery outcomes cohort with an MPR >70%
157659|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=70%|Participants in the prostate surgery outcomes cohort with an MPR <=70%
157660|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >70%|Participants in the acute urinary retention outcomes cohort with an MPR >70%
157661|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=70%|Participants in the acute urinary retention outcomes cohort with an MPR <=70%
157662|NCT01334723|E2|Reported Event|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
157663|NCT01334723|E1|Reported Event|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
157664|NCT01334710|B1|Baseline|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
157665|NCT01334710|P1|Participant Flow|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
157666|NCT01334710|O1|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
157667|NCT01334710|E1|Reported Event|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
157668|NCT01334606|B1|Baseline|All Study Participants|This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
157669|NCT01334606|P1|Participant Flow|All Study Participants|Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
157670|NCT01334606|O1|Outcome|All Subjects|Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed.
157671|NCT01334606|E3|Reported Event|8mmx31G Pen Needle|Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
157672|NCT01334606|E2|Reported Event|4mmx32G Pen Needle|Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
157673|NCT01334606|E1|Reported Event|All Study Participants|This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
157674|NCT01334554|B3|Baseline|Total|Total of all reporting groups
157675|NCT01334554|B2|Baseline|Placebo|Placebo three times a day for 4 weeks
157676|NCT01334554|B1|Baseline|Sildenafil|Sildenafil 20 mg three times a day for 4 weeks
157677|NCT01334554|P2|Participant Flow|Placebo|Participants received placebo three times a day for 4 weeks
157678|NCT01334554|P1|Participant Flow|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
157679|NCT01334554|O2|Outcome|Placebo|"placebo~Placebo: No active drug"
157680|NCT01334554|O1|Outcome|Sildenafil|"Sildenafil 20 mg three times a day~Sildenafil: 20 mg three times a day."
157681|NCT01334554|O2|Outcome|Placebo|Placebo tablets, 1 tablet three times a day
157682|NCT01334554|O1|Outcome|Sildenafil|Sildenafil: 20 mg TID
157683|NCT01334554|E2|Reported Event|Placebo|Participants received placebo three times a day for 4 weeks
157684|NCT01334554|E1|Reported Event|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
157685|NCT01334515|B3|Baseline|Total|Total of all reporting groups
157686|NCT01334515|B2|Baseline|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157697|NCT01334229|B2|Baseline|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
157698|NCT01334229|B1|Baseline|Sitagliptin First Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
157699|NCT01334229|P2|Participant Flow|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
157700|NCT01334229|P1|Participant Flow|Sitagliptin Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
157687|NCT01334515|B1|Baseline|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157688|NCT01334515|P2|Participant Flow|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157689|NCT01334515|P1|Participant Flow|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157690|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157691|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157692|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157693|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157694|NCT01334515|E2|Reported Event|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157695|NCT01334515|E1|Reported Event|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
157704|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157705|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157706|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157707|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157708|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157709|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157710|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157711|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157712|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157713|NCT01334229|E2|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
157714|NCT01334229|E1|Reported Event|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
157715|NCT01334125|B3|Baseline|Total|Total of all reporting groups
157716|NCT01334125|B2|Baseline|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
157717|NCT01334125|B1|Baseline|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157718|NCT01334125|P2|Participant Flow|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
157719|NCT01334125|P1|Participant Flow|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157720|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
157721|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157722|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
157723|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157724|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
157725|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157726|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
157727|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157728|NCT01334125|E2|Reported Event|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
157729|NCT01334125|E1|Reported Event|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
157730|NCT01333956|B5|Baseline|Total|Total of all reporting groups
157731|NCT01333956|B4|Baseline|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157732|NCT01333956|B3|Baseline|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157733|NCT01333956|B2|Baseline|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157734|NCT01333956|B1|Baseline|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157735|NCT01333956|P4|Participant Flow|150mg Arm|Patients will receive 150mg of pregabalin per dose.
157736|NCT01333956|P3|Participant Flow|100mg Arm|Patients will receive 100mg of pregabalin per dose.
157737|NCT01333956|P2|Participant Flow|50mg Arm|Patients will receive 50mg of pregabalin per dose.
157738|NCT01333956|P1|Participant Flow|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose."
157739|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157740|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157741|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157742|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157804|NCT01333592|B3|Baseline|Total|Total of all reporting groups
157743|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157744|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157745|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157746|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157747|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157748|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157749|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157750|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157751|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157752|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157753|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157754|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157755|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157756|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157757|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157758|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157759|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157760|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157761|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157805|NCT01333592|B2|Baseline|KAD-1229 / Biguanides|
157762|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157763|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157764|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157765|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157766|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16."
157767|NCT01333956|E4|Reported Event|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157768|NCT01333956|E3|Reported Event|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157769|NCT01333956|E2|Reported Event|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157770|NCT01333956|E1|Reported Event|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
157771|NCT01333865|B1|Baseline|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
157772|NCT01333865|P1|Participant Flow|Memantine (Namenda) Treatment|"Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
157773|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
157774|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
157806|NCT01333592|B1|Baseline|KAD-1229 / DPP-4 Inhibitors|
157807|NCT01333592|P2|Participant Flow|KAD-1229 / Biguanides|
157808|NCT01333592|P1|Participant Flow|KAD-1229 / DPP-4 Inhibitors|
157809|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
157810|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
157811|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
157812|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
157775|NCT01333865|E1|Reported Event|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
157776|NCT01333813|B1|Baseline|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157777|NCT01333813|P1|Participant Flow|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157778|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157779|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157780|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157781|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157782|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157783|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157784|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157785|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157786|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157787|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157788|NCT01333813|E1|Reported Event|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
157789|NCT01333722|B3|Baseline|Total|Total of all reporting groups
157790|NCT01333722|B2|Baseline|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157791|NCT01333722|B1|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157792|NCT01333722|P2|Participant Flow|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157793|NCT01333722|P1|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157794|NCT01333722|O2|Outcome|Placebo|placebo, 1 oral tablet every 12 hours
157795|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
157796|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157797|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157798|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157799|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157800|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157801|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157802|NCT01333722|E2|Reported Event|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
157803|NCT01333722|E1|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
157816|NCT01333488|B3|Baseline|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157817|NCT01333488|B2|Baseline|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157818|NCT01333488|B1|Baseline|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
157819|NCT01333488|P3|Participant Flow|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157820|NCT01333488|P2|Participant Flow|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157821|NCT01333488|P1|Participant Flow|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
157822|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157823|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157824|NCT01333488|O1|Outcome|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
157825|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157826|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157827|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
157828|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157829|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157830|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
157831|NCT01333488|E3|Reported Event|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
157832|NCT01333488|E2|Reported Event|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
157833|NCT01333488|E1|Reported Event|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
157834|NCT01333475|B3|Baseline|Total|Total of all reporting groups
157835|NCT01333475|B2|Baseline|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157836|NCT01333475|B1|Baseline|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157837|NCT01333475|P2|Participant Flow|TAC1A|"Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157838|NCT01333475|P1|Participant Flow|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157860|NCT01333397|B4|Baseline|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
158498|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
157839|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157840|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157841|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157842|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157843|NCT01333475|E2|Reported Event|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157844|NCT01333475|E1|Reported Event|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
157845|NCT01333436|B3|Baseline|Total|Total of all reporting groups
157846|NCT01333436|B2|Baseline|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein).
157847|NCT01333436|B1|Baseline|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein.
157848|NCT01333436|P2|Participant Flow|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157849|NCT01333436|P1|Participant Flow|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157850|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157851|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157852|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157853|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157854|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157855|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157856|NCT01333436|E2|Reported Event|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157857|NCT01333436|E1|Reported Event|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
157858|NCT01333397|B6|Baseline|Total|Total of all reporting groups
157859|NCT01333397|B5|Baseline|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
158499|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
157861|NCT01333397|B3|Baseline|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157862|NCT01333397|B2|Baseline|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157863|NCT01333397|B1|Baseline|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157864|NCT01333397|P5|Participant Flow|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157865|NCT01333397|P4|Participant Flow|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157866|NCT01333397|P3|Participant Flow|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157867|NCT01333397|P2|Participant Flow|Dysport NG 20 U|"Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)~Ready to Use (RU)"
157868|NCT01333397|P1|Participant Flow|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157869|NCT01333397|O2|Outcome|Dysport 50 U|
157870|NCT01333397|O1|Outcome|Placebo|
157871|NCT01333397|O4|Outcome|Dysport 50 U|
157872|NCT01333397|O3|Outcome|Dysport NG 75 U|
157873|NCT01333397|O2|Outcome|Dysport NG 50 U|
157874|NCT01333397|O1|Outcome|Dysport NG 20 U|
157875|NCT01333397|O4|Outcome|Dysport 50 U|
157876|NCT01333397|O3|Outcome|Dysport NG 75 U|
157877|NCT01333397|O2|Outcome|Dysport NG 50 U|
157878|NCT01333397|O1|Outcome|Dysport NG 20 U|
157879|NCT01333397|O4|Outcome|Dysport 50 U|
157880|NCT01333397|O3|Outcome|Dysport NG 75 U|
157881|NCT01333397|O2|Outcome|Dysport NG 50 U|
157882|NCT01333397|O1|Outcome|Dysport NG 20 U|
157883|NCT01333397|O5|Outcome|Dysport 50 U|
157884|NCT01333397|O4|Outcome|Dysport NG 75 U|
157885|NCT01333397|O3|Outcome|Dysport NG 50 U|
157886|NCT01333397|O2|Outcome|Dysport NG 20 U|
157887|NCT01333397|O1|Outcome|Placebo|
157888|NCT01333397|O5|Outcome|Dysport 50 U|
157889|NCT01333397|O4|Outcome|Dysport NG 75 U|
157890|NCT01333397|O3|Outcome|Dysport NG 50 U|
157891|NCT01333397|O2|Outcome|Dysport NG 20 U|
157892|NCT01333397|O1|Outcome|Placebo|
157893|NCT01333397|O5|Outcome|Dysport 50 U|
157894|NCT01333397|O4|Outcome|Dysport NG 75 U|
157895|NCT01333397|O3|Outcome|Dysport NG 50 U|
157896|NCT01333397|O2|Outcome|Dysport NG 20 U|
157897|NCT01333397|O1|Outcome|Placebo|
157898|NCT01333397|O5|Outcome|Dysport 50 U|
157899|NCT01333397|O4|Outcome|Dysport NG 75 U|
157900|NCT01333397|O3|Outcome|Dysport NG 50 U|
157901|NCT01333397|O2|Outcome|Dysport NG 20 U|
157902|NCT01333397|O1|Outcome|Placebo|
157903|NCT01333397|O5|Outcome|Dysport 50 U|
157904|NCT01333397|O4|Outcome|Dysport NG 75 U|
157905|NCT01333397|O3|Outcome|Dysport NG 50 U|
157906|NCT01333397|O2|Outcome|Dysport NG 20 U|
157907|NCT01333397|O1|Outcome|Placebo|
157908|NCT01333397|O4|Outcome|Dysport NG 75 U|
157909|NCT01333397|O3|Outcome|Dysport NG 50 U|
157910|NCT01333397|O2|Outcome|Dysport NG 20 U|
157911|NCT01333397|O1|Outcome|Placebo|
157912|NCT01333397|O5|Outcome|Dysport 50 U|
157913|NCT01333397|O4|Outcome|Dysport NG 75 U|
157914|NCT01333397|O3|Outcome|Dysport NG 50 U|
157915|NCT01333397|O2|Outcome|Dysport NG 20 U|
157916|NCT01333397|O1|Outcome|Placebo|
157917|NCT01333397|O4|Outcome|Dysport NG 75 U|
157918|NCT01333397|O3|Outcome|Dysport NG 50 U|
157919|NCT01333397|O2|Outcome|Dysport NG 20 U|
157920|NCT01333397|O1|Outcome|Placebo|
157921|NCT01333397|O4|Outcome|Dysport NG 75 U|
157922|NCT01333397|O3|Outcome|Dysport NG 50 U|
157923|NCT01333397|O2|Outcome|Dysport NG 20 U|
157924|NCT01333397|O1|Outcome|Placebo|
157925|NCT01333397|O5|Outcome|Dysport 50 U|
157926|NCT01333397|O4|Outcome|Dysport NG 75 U|
157927|NCT01333397|O3|Outcome|Dysport NG 50 U|
157928|NCT01333397|O2|Outcome|Dysport NG 20 U|
157929|NCT01333397|O1|Outcome|Placebo|
157930|NCT01333397|O4|Outcome|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
158370|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
180807|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
157931|NCT01333397|O3|Outcome|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157932|NCT01333397|O2|Outcome|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157933|NCT01333397|O1|Outcome|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157934|NCT01333397|E5|Reported Event|Dysport 50 U|Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157935|NCT01333397|E4|Reported Event|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157936|NCT01333397|E3|Reported Event|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157937|NCT01333397|E2|Reported Event|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157938|NCT01333397|E1|Reported Event|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
157939|NCT01333189|B3|Baseline|Total|Total of all reporting groups
157940|NCT01333189|B2|Baseline|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157941|NCT01333189|B1|Baseline|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157942|NCT01333189|P2|Participant Flow|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157943|NCT01333189|P1|Participant Flow|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157944|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
158115|NCT01332435|B2|Baseline|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158371|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
157945|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157946|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157947|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157948|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157949|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157950|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157951|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157952|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
158041|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
157953|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157954|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157955|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157956|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157957|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157958|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157959|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157960|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
158042|NCT01332721|E1|Reported Event|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
157961|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157962|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157963|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157964|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157965|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157966|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
157967|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157968|NCT01333189|E2|Reported Event|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
158043|NCT01332578|B1|Baseline|All Randomized Participants|All randomized participants who received a study treatment during the cross over study.
158044|NCT01332578|P2|Participant Flow|Standard Paracetamol Tablets First, Then Hot Drink Remedy|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period).
159095|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
157969|NCT01333189|E1|Reported Event|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
157970|NCT01332994|B1|Baseline|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157971|NCT01332994|P1|Participant Flow|Tocilizumab (TCZ)/TCZ or TCZ/Rituximab (RTX)|All participants were assigned to receive TCZ 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using Disease Activity Score Based on 28-Joint Count (DAS28) to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of less than (<) 2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score greater than (>) 1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score less than or equal to (≤) 1.2 or a score >3.2, received RTX 1000 milligrams (mg) via IV infusion at Weeks 16 and 18.
157972|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157973|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157974|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157975|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157976|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158133|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
157977|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157978|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157979|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157980|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157981|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157982|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157983|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157984|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158045|NCT01332578|P1|Participant Flow|Hot Drink Remedy First, Then Standard Paracetamol Tablets|Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period).
158046|NCT01332578|O1|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
157985|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157986|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157987|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157988|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157989|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157990|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157991|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157992|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158047|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
158048|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
158049|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
159096|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
157993|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157994|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157995|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157996|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157997|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157998|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
157999|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158000|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158050|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
158051|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
158052|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
180808|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
158001|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158002|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158003|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158004|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158005|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158006|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158007|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158008|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158053|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
158054|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
158055|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
159757|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
158009|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158010|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158011|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158012|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158013|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158014|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158015|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158016|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158056|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
158057|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
158058|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
180809|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
158017|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158018|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158019|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158020|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158021|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158022|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158023|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158024|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158059|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
158060|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
158061|NCT01332578|E2|Reported Event|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
159758|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
158025|NCT01332994|E1|Reported Event|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
158026|NCT01332981|B1|Baseline|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158027|NCT01332981|P1|Participant Flow|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158028|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
158029|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
158030|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
158031|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
158032|NCT01332981|O1|Outcome|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158033|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158034|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158035|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158036|NCT01332981|E1|Reported Event|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
158037|NCT01332721|B1|Baseline|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
158038|NCT01332721|P1|Participant Flow|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
158039|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
158040|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
158062|NCT01332578|E1|Reported Event|Hot Drink Remedy|Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water.
158063|NCT01332500|B5|Baseline|Total|Total of all reporting groups
159759|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
158064|NCT01332500|B4|Baseline|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158065|NCT01332500|B3|Baseline|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158066|NCT01332500|B2|Baseline|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
158067|NCT01332500|B1|Baseline|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158068|NCT01332500|P4|Participant Flow|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158069|NCT01332500|P3|Participant Flow|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158070|NCT01332500|P2|Participant Flow|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
158071|NCT01332500|P1|Participant Flow|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158072|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158073|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158112|NCT01332435|B5|Baseline|Total|Total of all reporting groups
158113|NCT01332435|B4|Baseline|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
159760|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
158074|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158075|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158076|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158077|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158078|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158079|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158080|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158081|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158082|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158083|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158114|NCT01332435|B3|Baseline|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158490|NCT01332019|P2|Participant Flow|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158084|NCT01332500|E4|Reported Event|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158085|NCT01332500|E3|Reported Event|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158086|NCT01332500|E2|Reported Event|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
158087|NCT01332500|E1|Reported Event|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
158088|NCT01332487|B3|Baseline|Total|Total of all reporting groups
158089|NCT01332487|B2|Baseline|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
158090|NCT01332487|B1|Baseline|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
158091|NCT01332487|P2|Participant Flow|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
158092|NCT01332487|P1|Participant Flow|Early Treatment|Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment
158093|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
158094|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
158095|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
158096|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
158097|NCT01332487|E2|Reported Event|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
158098|NCT01332487|E1|Reported Event|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
158099|NCT01332461|B3|Baseline|Total|Total of all reporting groups
158100|NCT01332461|B2|Baseline|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158101|NCT01332461|B1|Baseline|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158102|NCT01332461|P2|Participant Flow|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158103|NCT01332461|P1|Participant Flow|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158104|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158105|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158106|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158107|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158108|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158109|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158110|NCT01332461|E2|Reported Event|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
158111|NCT01332461|E1|Reported Event|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
158116|NCT01332435|B1|Baseline|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158117|NCT01332435|P4|Participant Flow|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158118|NCT01332435|P3|Participant Flow|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158119|NCT01332435|P2|Participant Flow|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158120|NCT01332435|P1|Participant Flow|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158121|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158122|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158123|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158124|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158125|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158126|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158127|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158128|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158129|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158130|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158131|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158132|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158316|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158134|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158135|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158136|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158137|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158138|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158139|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158140|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158141|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158142|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158143|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158144|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158145|NCT01332435|E4|Reported Event|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158146|NCT01332435|E3|Reported Event|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158147|NCT01332435|E2|Reported Event|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
158148|NCT01332435|E1|Reported Event|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
158149|NCT01332357|B1|Baseline|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
158150|NCT01332357|P1|Participant Flow|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
158151|NCT01332357|O1|Outcome|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
158152|NCT01332357|E1|Reported Event|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
158153|NCT01332318|B5|Baseline|Total|Total of all reporting groups
158154|NCT01332318|B4|Baseline|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158155|NCT01332318|B3|Baseline|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158156|NCT01332318|B2|Baseline|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158157|NCT01332318|B1|Baseline|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158158|NCT01332318|P4|Participant Flow|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158159|NCT01332318|P3|Participant Flow|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158160|NCT01332318|P2|Participant Flow|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158161|NCT01332318|P1|Participant Flow|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158162|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158163|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158164|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158165|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158166|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158167|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158168|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158317|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158169|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158170|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158171|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158172|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158173|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158174|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158175|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158176|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158177|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158178|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158179|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158180|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158181|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158182|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158183|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
180810|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
158184|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158185|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158186|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158187|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158188|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158189|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158190|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158191|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158192|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158193|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158194|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158195|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158196|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158197|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158198|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
159761|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
158199|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158200|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158201|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158202|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158203|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158204|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158205|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158206|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158207|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158208|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158209|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158210|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158211|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158212|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158213|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158214|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
180811|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
158215|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158216|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158217|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158218|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158219|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158220|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158221|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158222|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158223|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158224|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158225|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158226|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158227|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158228|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158229|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158230|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
180812|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
158231|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158232|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158233|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158234|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158235|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158236|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158237|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158238|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158239|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158240|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158241|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158242|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158243|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158244|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158245|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158246|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
180813|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
158247|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158248|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158249|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158250|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158251|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158252|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158253|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158254|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158255|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158256|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158257|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158258|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158259|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158260|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158261|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158262|NCT01332318|E4|Reported Event|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158263|NCT01332318|E3|Reported Event|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158264|NCT01332318|E2|Reported Event|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
158265|NCT01332318|E1|Reported Event|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
158266|NCT01332305|B6|Baseline|Total|Total of all reporting groups
158267|NCT01332305|B5|Baseline|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158268|NCT01332305|B4|Baseline|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158269|NCT01332305|B3|Baseline|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158270|NCT01332305|B2|Baseline|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158271|NCT01332305|B1|Baseline|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158272|NCT01332305|P5|Participant Flow|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158273|NCT01332305|P4|Participant Flow|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158274|NCT01332305|P3|Participant Flow|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158275|NCT01332305|P2|Participant Flow|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158276|NCT01332305|P1|Participant Flow|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158277|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158278|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158318|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158279|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158280|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158281|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158282|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158283|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158284|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158285|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158286|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158287|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158288|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158289|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158290|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158291|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158292|NCT01332305|E5|Reported Event|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
158293|NCT01332305|E4|Reported Event|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
158294|NCT01332305|E3|Reported Event|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158295|NCT01332305|E2|Reported Event|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158296|NCT01332305|E1|Reported Event|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
158297|NCT01332292|B1|Baseline|FF 100 µg/Placebo or Placebo/FF 100 µg|Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158298|NCT01332292|P2|Participant Flow|Sequence 2: Placebo Followed by FF 100 µg|Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
158299|NCT01332292|P1|Participant Flow|Sequence 1: FF 100 µg Followed by Placebo|Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
158300|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158301|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158302|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158303|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158304|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158305|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158306|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158307|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158308|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158309|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158310|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158311|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158312|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158313|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158314|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158315|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158491|NCT01332019|P1|Participant Flow|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158319|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158320|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158321|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158322|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158323|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158324|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158325|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158326|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158327|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158328|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158329|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158330|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158331|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158332|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158333|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158334|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158335|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158336|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158337|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158338|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158339|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158340|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158341|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158369|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158342|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158343|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158344|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158345|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158346|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158347|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158348|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158349|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158350|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158351|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158352|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158353|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158354|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158355|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158356|NCT01332292|E2|Reported Event|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158357|NCT01332292|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
158358|NCT01332253|B3|Baseline|Total|Total of all reporting groups
158359|NCT01332253|B2|Baseline|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158360|NCT01332253|B1|Baseline|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158361|NCT01332253|P2|Participant Flow|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158362|NCT01332253|P1|Participant Flow|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158363|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158364|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158365|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158366|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158367|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158368|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158492|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158372|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158373|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158374|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158375|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158376|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158377|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158378|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158379|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158380|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158381|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158382|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158383|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158384|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158385|NCT01332253|E2|Reported Event|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
158386|NCT01332253|E1|Reported Event|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
158387|NCT01332227|B3|Baseline|Total|Total of all reporting groups
158388|NCT01332227|B2|Baseline|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158389|NCT01332227|B1|Baseline|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158390|NCT01332227|P2|Participant Flow|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158391|NCT01332227|P1|Participant Flow|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158392|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158393|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158394|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158395|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158396|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158397|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158398|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158399|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158400|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158401|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158402|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158403|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158404|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
159762|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
158405|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158406|NCT01332227|E2|Reported Event|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
158407|NCT01332227|E1|Reported Event|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
158408|NCT01332149|B3|Baseline|Total|Total of all reporting groups
158409|NCT01332149|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158410|NCT01332149|B1|Baseline|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158411|NCT01332149|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158412|NCT01332149|P1|Participant Flow|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158413|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158414|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158415|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158416|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158417|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158418|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158419|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158420|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158421|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158422|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158423|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158424|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158425|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158493|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158426|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158427|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158428|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158429|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158430|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158431|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158432|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158433|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158434|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158435|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158436|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158437|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158438|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158439|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158440|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158441|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158442|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158443|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158494|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158495|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
159763|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
158444|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158445|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158446|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158447|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158448|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158449|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158450|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158451|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158452|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158453|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158454|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158455|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158456|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158457|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158458|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158459|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158460|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158461|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158496|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158497|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
159764|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
158462|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158463|NCT01332149|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
158464|NCT01332149|E1|Reported Event|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
158465|NCT01332123|B1|Baseline|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
158466|NCT01332123|P1|Participant Flow|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
158467|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
158468|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons."
158469|NCT01332123|E1|Reported Event|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
158470|NCT01332071|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2
158471|NCT01332071|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
158472|NCT01332071|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
158473|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
158474|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
158475|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
158476|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
158477|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
158478|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
158479|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
158480|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
158481|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
158482|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
158483|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
158484|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
158485|NCT01332071|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
158486|NCT01332071|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
158487|NCT01332019|B3|Baseline|Total|Total of all reporting groups
158488|NCT01332019|B2|Baseline|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158489|NCT01332019|B1|Baseline|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158500|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158501|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158502|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158503|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158504|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158505|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158506|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158507|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158508|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158509|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158510|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158511|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158512|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158513|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158514|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158515|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158516|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158517|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158518|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158519|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158520|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158521|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158522|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158523|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158524|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158525|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158526|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158527|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158528|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158529|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158530|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158531|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158532|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158533|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158534|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158535|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158536|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158537|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158538|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158539|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158540|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158541|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158542|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158543|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158544|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158545|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158546|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158547|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158548|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158549|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158550|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158551|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158552|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158553|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158554|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158555|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158556|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158557|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158558|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158559|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158560|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158561|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158562|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158563|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158564|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158565|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158566|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158567|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158568|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158569|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158570|NCT01332019|E2|Reported Event|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
158571|NCT01332019|E1|Reported Event|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
158572|NCT01331824|B1|Baseline|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158573|NCT01331824|P1|Participant Flow|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158574|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158575|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158576|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158577|NCT01331824|E1|Reported Event|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
158578|NCT01331694|B7|Baseline|Total|Total of all reporting groups
158579|NCT01331694|B6|Baseline|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158580|NCT01331694|B5|Baseline|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158581|NCT01331694|B4|Baseline|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158582|NCT01331694|B3|Baseline|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158583|NCT01331694|B2|Baseline|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158584|NCT01331694|B1|Baseline|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158585|NCT01331694|P6|Participant Flow|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158586|NCT01331694|P5|Participant Flow|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158587|NCT01331694|P4|Participant Flow|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158588|NCT01331694|P3|Participant Flow|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158589|NCT01331694|P2|Participant Flow|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158590|NCT01331694|P1|Participant Flow|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg
158591|NCT01331694|O3|Outcome|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158592|NCT01331694|O2|Outcome|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158593|NCT01331694|O1|Outcome|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158594|NCT01331694|O3|Outcome|Risk Population TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158595|NCT01331694|O2|Outcome|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158596|NCT01331694|O1|Outcome|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158597|NCT01331694|E6|Reported Event|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158598|NCT01331694|E5|Reported Event|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158599|NCT01331694|E4|Reported Event|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158600|NCT01331694|E3|Reported Event|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
158601|NCT01331694|E2|Reported Event|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
158602|NCT01331694|E1|Reported Event|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
158603|NCT01331681|B4|Baseline|Total|Total of all reporting groups
158604|NCT01331681|B3|Baseline|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158605|NCT01331681|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158606|NCT01331681|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158607|NCT01331681|P3|Participant Flow|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158608|NCT01331681|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158609|NCT01331681|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158610|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158611|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158612|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158613|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158614|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158615|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158616|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158617|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158618|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158619|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158620|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158621|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158622|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158623|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158624|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158625|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158626|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158627|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158628|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
158629|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158630|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158631|NCT01331681|E3|Reported Event|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
158632|NCT01331681|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
158633|NCT01331681|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
158634|NCT01331304|B3|Baseline|Total|Total of all reporting groups
158635|NCT01331304|B2|Baseline|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
158636|NCT01331304|B1|Baseline|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
158637|NCT01331304|P2|Participant Flow|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
158638|NCT01331304|P1|Participant Flow|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
158639|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
158640|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
158641|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
158642|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
158643|NCT01331304|E2|Reported Event|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
158644|NCT01331304|E1|Reported Event|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
158645|NCT01331291|B3|Baseline|Total|Total of all reporting groups
158646|NCT01331291|B2|Baseline|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158647|NCT01331291|B1|Baseline|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158648|NCT01331291|P2|Participant Flow|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158649|NCT01331291|P1|Participant Flow|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158650|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158651|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158652|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158653|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158654|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158655|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158656|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
158657|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
158658|NCT01331291|E1|Reported Event|Combined Arms|Adverse Events were measured across all participants, regardless of arm.
158659|NCT01331213|B3|Baseline|Total|Total of all reporting groups
158660|NCT01331213|B2|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158661|NCT01331213|B1|Baseline|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158662|NCT01331213|P2|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158663|NCT01331213|P1|Participant Flow|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158664|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158665|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158666|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158667|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158668|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158669|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158670|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158671|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158672|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158673|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158674|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158675|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158676|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158677|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158678|NCT01331213|E2|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
158679|NCT01331213|E1|Reported Event|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
158680|NCT01331161|B3|Baseline|Total|Total of all reporting groups
158681|NCT01331161|B2|Baseline|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
158682|NCT01331161|B1|Baseline|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
158683|NCT01331161|P2|Participant Flow|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
158684|NCT01331161|P1|Participant Flow|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
158685|NCT01331161|O2|Outcome|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
158686|NCT01331161|O1|Outcome|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
158687|NCT01331161|O2|Outcome|Participants 25-40 Years of Age|participants with one dose of vaccine
158688|NCT01331161|O1|Outcome|Participants 60-79 Years|participants who received one dose of vaccine
158689|NCT01331161|E2|Reported Event|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
158690|NCT01331161|E1|Reported Event|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
158691|NCT01331109|B1|Baseline|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158692|NCT01331109|P1|Participant Flow|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158693|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158694|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158695|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158696|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158697|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158698|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158699|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158700|NCT01331109|E1|Reported Event|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
158701|NCT01331005|B3|Baseline|Total|Total of all reporting groups
158702|NCT01331005|B2|Baseline|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
158703|NCT01331005|B1|Baseline|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
158704|NCT01331005|P2|Participant Flow|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
158705|NCT01331005|P1|Participant Flow|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
158706|NCT01331005|O2|Outcome|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
158707|NCT01331005|O1|Outcome|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
158708|NCT01331005|E2|Reported Event|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
158709|NCT01331005|E1|Reported Event|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
158710|NCT01330914|B1|Baseline|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
158711|NCT01330914|P1|Participant Flow|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
158712|NCT01330914|O1|Outcome|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
158713|NCT01330914|E1|Reported Event|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
158714|NCT01330628|B3|Baseline|Total|Total of all reporting groups
158715|NCT01330628|B2|Baseline|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
158716|NCT01330628|B1|Baseline|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
158717|NCT01330628|P2|Participant Flow|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
158718|NCT01330628|P1|Participant Flow|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
158719|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
158720|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
158721|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
158722|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
158723|NCT01330628|E2|Reported Event|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
158724|NCT01330628|E1|Reported Event|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
158725|NCT01330433|B3|Baseline|Total|Total of all reporting groups
158726|NCT01330433|B2|Baseline|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158727|NCT01330433|B1|Baseline|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158728|NCT01330433|P2|Participant Flow|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158729|NCT01330433|P1|Participant Flow|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158730|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158731|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158732|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158733|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158734|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158735|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158736|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158737|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158738|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
159097|NCT01329848|E1|Reported Event|Changes in Visual Discomfort From Baseline|Visual discomfort while making auto-refraction recordings.
158739|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158740|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158741|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158742|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158743|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158744|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158745|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158746|NCT01330433|E2|Reported Event|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
158747|NCT01330433|E1|Reported Event|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
158748|NCT01330420|B1|Baseline|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
158749|NCT01330420|P1|Participant Flow|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158750|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158751|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158752|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158753|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158754|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
158755|NCT01330420|E1|Reported Event|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
158756|NCT01330394|B3|Baseline|Total|Total of all reporting groups
158757|NCT01330394|B2|Baseline|Active tDCS|active transcranial Direct Current Stimulation
158758|NCT01330394|B1|Baseline|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
158759|NCT01330394|P2|Participant Flow|Active tDCS|active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
158760|NCT01330394|P1|Participant Flow|Sham-tDCS Control|simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
158761|NCT01330394|O2|Outcome|Active tDCS|active transcranial Direct Current Stimulation
158762|NCT01330394|O1|Outcome|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
158763|NCT01330394|E2|Reported Event|Active tDCS|active transcranial Direct Current Stimulation
158764|NCT01330394|E1|Reported Event|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
158765|NCT01330381|B3|Baseline|Total|Total of all reporting groups
158766|NCT01330381|B2|Baseline|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158767|NCT01330381|B1|Baseline|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158768|NCT01330381|P3|Participant Flow|PEG 4000 (Polyethylene Glycol)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
158769|NCT01330381|P2|Participant Flow|Placebo|"Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution.~Subjects with weight >50 kg received placebo matching prucalopride oral tablet."
158770|NCT01330381|P1|Participant Flow|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158771|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
158772|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158773|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
158774|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158775|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158776|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158777|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
158778|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158779|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158780|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158781|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158782|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158783|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158784|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158785|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158786|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
180814|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
158787|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158788|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158789|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158790|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158791|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158792|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158793|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158794|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158795|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158796|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158797|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158798|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158799|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158800|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158801|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158802|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158803|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158804|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158805|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158806|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158807|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158808|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158809|NCT01330381|E4|Reported Event|PEG 4000 (Open-label Period)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
158810|NCT01330381|E3|Reported Event|Prucalopride (Open-label Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158811|NCT01330381|E2|Reported Event|Placebo (Double-blind Period)|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
158812|NCT01330381|E1|Reported Event|Prucalopride (Double-blind Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
158813|NCT01330355|B3|Baseline|Total|Total of all reporting groups
158814|NCT01330355|B2|Baseline|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158815|NCT01330355|B1|Baseline|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158816|NCT01330355|P2|Participant Flow|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158817|NCT01330355|P1|Participant Flow|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158818|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158819|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158820|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158821|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158822|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158823|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158824|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158825|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158826|NCT01330355|E2|Reported Event|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
158827|NCT01330355|E1|Reported Event|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
158828|NCT01330316|B3|Baseline|Total|Total of all reporting groups
158829|NCT01330316|B2|Baseline|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158830|NCT01330316|B1|Baseline|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158831|NCT01330316|P2|Participant Flow|Non-relapse|"Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.~Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.~Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.~Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment."
158832|NCT01330316|P1|Participant Flow|Relapse|"Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.~At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.~ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.~Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser."
158833|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158834|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158835|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158836|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158837|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158838|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158839|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158840|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158841|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158842|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158843|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158844|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158845|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158846|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158847|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158848|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158849|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158850|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158851|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158852|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158853|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158854|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158855|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158856|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158857|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158858|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158859|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158860|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158861|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158862|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158863|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158864|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158865|NCT01330316|E2|Reported Event|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
158866|NCT01330316|E1|Reported Event|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
158867|NCT01330303|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2
158868|NCT01330303|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
158869|NCT01330303|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
158870|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
158871|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
158872|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
158873|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
158874|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods
158875|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
158876|NCT01330303|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
158877|NCT01330303|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
158878|NCT01330290|B1|Baseline|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158879|NCT01330290|P1|Participant Flow|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158880|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
159765|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
158881|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158882|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158883|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158884|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158885|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158886|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158887|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158888|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158889|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158890|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158891|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158892|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158893|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158920|NCT01330017|B2|Baseline|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
159766|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
158894|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158895|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158896|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158897|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158898|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158899|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158900|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158901|NCT01330290|E1|Reported Event|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
158902|NCT01330108|B1|Baseline|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
158903|NCT01330108|P1|Participant Flow|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
158904|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
158905|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
158906|NCT01330108|E1|Reported Event|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
158907|NCT01330030|B3|Baseline|Total|Total of all reporting groups
158908|NCT01330030|B2|Baseline|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
158909|NCT01330030|B1|Baseline|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
158910|NCT01330030|P2|Participant Flow|Matching Placebo|matching placebo worn 24 hours for 8 weeks
158911|NCT01330030|P1|Participant Flow|Drug Selegiline|6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
158912|NCT01330030|O2|Outcome|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
158913|NCT01330030|O1|Outcome|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
158914|NCT01330030|E2|Reported Event|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
158915|NCT01330030|E1|Reported Event|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
158916|NCT01330017|B6|Baseline|Total|Total of all reporting groups
158917|NCT01330017|B5|Baseline|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
158918|NCT01330017|B4|Baseline|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158919|NCT01330017|B3|Baseline|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
180815|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
158921|NCT01330017|B1|Baseline|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158922|NCT01330017|P5|Participant Flow|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
158923|NCT01330017|P4|Participant Flow|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158924|NCT01330017|P3|Participant Flow|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158925|NCT01330017|P2|Participant Flow|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158926|NCT01330017|P1|Participant Flow|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158927|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158928|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158929|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158930|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158931|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158932|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158933|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158934|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158935|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158936|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158937|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158938|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158939|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158940|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158941|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158942|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158943|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158944|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158945|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158946|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158947|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158948|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158949|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158950|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158951|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158952|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158953|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158954|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158955|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158956|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158957|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158958|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158959|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158960|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158961|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158962|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158963|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158964|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158965|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158966|NCT01330017|E5|Reported Event|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
158967|NCT01330017|E4|Reported Event|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
158968|NCT01330017|E3|Reported Event|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
158969|NCT01330017|E2|Reported Event|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
158970|NCT01330017|E1|Reported Event|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
158971|NCT01329978|B4|Baseline|Total|Total of all reporting groups
158972|NCT01329978|B3|Baseline|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
158973|NCT01329978|B2|Baseline|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158974|NCT01329978|B1|Baseline|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
158975|NCT01329978|P5|Participant Flow|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
158976|NCT01329978|P4|Participant Flow|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
158977|NCT01329978|P3|Participant Flow|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
158978|NCT01329978|P2|Participant Flow|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158979|NCT01329978|P1|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.
158980|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
158981|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
158982|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
158983|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158984|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
158985|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
158986|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
158987|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
158988|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158989|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
158990|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
158991|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
158992|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
158993|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158994|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
158995|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
158996|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
158997|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
158998|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
158999|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159000|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159001|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159002|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
159003|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
159004|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159005|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
180816|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
159006|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159007|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159008|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159009|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159010|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159011|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159012|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159013|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159014|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159015|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159016|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159017|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159018|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159019|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159020|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159021|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159022|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159023|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159024|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159025|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159026|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159027|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159028|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159029|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159030|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
159031|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
159032|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159033|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159034|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159035|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
159036|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
159037|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159038|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159039|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159040|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
159041|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
159042|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159043|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159044|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159045|NCT01329978|E3|Reported Event|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
159046|NCT01329978|E2|Reported Event|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
159047|NCT01329978|E1|Reported Event|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
159048|NCT01329939|B5|Baseline|Total|Total of all reporting groups
159049|NCT01329939|B4|Baseline|Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159050|NCT01329939|B3|Baseline|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159051|NCT01329939|B2|Baseline|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159052|NCT01329939|B1|Baseline|Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159053|NCT01329939|P4|Participant Flow|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159054|NCT01329939|P3|Participant Flow|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159055|NCT01329939|P2|Participant Flow|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159056|NCT01329939|P1|Participant Flow|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159057|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159058|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159059|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159060|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159061|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159062|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159063|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159064|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159065|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159066|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159067|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159068|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159069|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159070|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159071|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159072|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159073|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159074|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159075|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159076|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159077|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159078|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159079|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159080|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159081|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159082|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159083|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159084|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159085|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159086|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159087|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159088|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159089|NCT01329939|E4|Reported Event|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159090|NCT01329939|E3|Reported Event|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159091|NCT01329939|E2|Reported Event|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
159092|NCT01329939|E1|Reported Event|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
159093|NCT01329848|B1|Baseline|Discomfort Symptoms|level of discomfort symptoms while performing near work
159094|NCT01329848|P1|Participant Flow|Discomfort Symptoms|levels of discomfort while performing near work
159098|NCT01329679|B1|Baseline|All Study Participants|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
159099|NCT01329679|P2|Participant Flow|Placebo, Then Energy Drink|
159100|NCT01329679|P1|Participant Flow|Energy Drink, Then Placebo|
159101|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159102|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159103|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159104|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159105|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159106|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159107|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159108|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159109|NCT01329679|O2|Outcome|Placebo|
159110|NCT01329679|O1|Outcome|5 Hour Energy|
159111|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159112|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159113|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
159114|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159115|NCT01329679|E2|Reported Event|Placebo|Placebo: Water, lime juice and cherry flavoring
159116|NCT01329679|E1|Reported Event|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
159117|NCT01329562|B3|Baseline|Total|Total of all reporting groups
159118|NCT01329562|B2|Baseline|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159119|NCT01329562|B1|Baseline|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159120|NCT01329562|P2|Participant Flow|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159121|NCT01329562|P1|Participant Flow|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159122|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159123|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159124|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159125|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159126|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159169|NCT01329549|B1|Baseline|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159127|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159128|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159129|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159130|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159131|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159132|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159133|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159134|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159135|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159136|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159137|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159138|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159139|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159140|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159170|NCT01329549|P1|Participant Flow|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159141|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159142|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159143|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159144|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159145|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159146|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159147|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159148|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159149|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159150|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159151|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159152|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159370|NCT01328769|P2|Participant Flow|Placebo|Matching placebo dose 80mg once daily
159371|NCT01328769|P1|Participant Flow|Febuxostat|80mg once daily
159153|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159154|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159155|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159156|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159157|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159158|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159159|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159160|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159161|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159162|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159163|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159164|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159165|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159166|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159167|NCT01329562|E2|Reported Event|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
159168|NCT01329562|E1|Reported Event|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
159171|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159172|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159173|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159174|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159175|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159176|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159177|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159178|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159179|NCT01329549|E1|Reported Event|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
159180|NCT01329419|B1|Baseline|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
159181|NCT01329419|P1|Participant Flow|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
159182|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
159183|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
159184|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
159185|NCT01329419|E1|Reported Event|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
159186|NCT01329263|B3|Baseline|Total|Total of all reporting groups
159187|NCT01329263|B2|Baseline|Control|Participants smoked their own menthol brand cigarette throughout the study.
159188|NCT01329263|B1|Baseline|Experimental|Group switched from menthol cigarette to non-menthol cigarette
159189|NCT01329263|P2|Participant Flow|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
159190|NCT01329263|P1|Participant Flow|Control|Control group: continued to smoke same, own brand cigarette.
159191|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
159192|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
159193|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
159194|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
159195|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
159196|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
159197|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
159198|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
159199|NCT01329263|E2|Reported Event|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
159200|NCT01329263|E1|Reported Event|Control|Control group: continued to smoke same, own brand cigarette.
159201|NCT01329198|B3|Baseline|Total|Total of all reporting groups
159202|NCT01329198|B2|Baseline|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159203|NCT01329198|B1|Baseline|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159372|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
159373|NCT01328769|O1|Outcome|Febuxostat|80mg daily
159204|NCT01329198|P2|Participant Flow|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159205|NCT01329198|P1|Participant Flow|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159206|NCT01329198|O5|Outcome|Subject 5|
159207|NCT01329198|O4|Outcome|Subject 4|
159208|NCT01329198|O3|Outcome|Subject 3|
159209|NCT01329198|O2|Outcome|Subject 2|
159210|NCT01329198|O1|Outcome|Subject 1|
159211|NCT01329198|O2|Outcome|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159212|NCT01329198|O1|Outcome|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159213|NCT01329198|E2|Reported Event|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159214|NCT01329198|E1|Reported Event|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
159215|NCT01329185|B3|Baseline|Total|Total of all reporting groups
159216|NCT01329185|B2|Baseline|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
159217|NCT01329185|B1|Baseline|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
159218|NCT01329185|P2|Participant Flow|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
159219|NCT01329185|P1|Participant Flow|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
159220|NCT01329185|O2|Outcome|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
159221|NCT01329185|O1|Outcome|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
159222|NCT01329185|E2|Reported Event|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
159223|NCT01329185|E1|Reported Event|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
159224|NCT01329029|B3|Baseline|Total|Total of all reporting groups
159225|NCT01329029|B2|Baseline|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159374|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
159375|NCT01328769|O1|Outcome|Febuxostat|80mg daily
159226|NCT01329029|B1|Baseline|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159227|NCT01329029|P2|Participant Flow|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159228|NCT01329029|P1|Participant Flow|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159229|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159230|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159231|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159232|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159233|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159234|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159235|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159236|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159237|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159238|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159239|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159240|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159241|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159242|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159243|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159244|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159245|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159246|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159247|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159248|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159249|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159250|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159251|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159252|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159253|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159254|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159255|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159376|NCT01328769|E2|Reported Event|Placebo|
159377|NCT01328769|E1|Reported Event|Febuxostat|
159256|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159257|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159258|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159259|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159260|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159261|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159262|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159263|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159264|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159265|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159266|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159267|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159268|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159269|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159270|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159271|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159272|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159273|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159274|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159275|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159276|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159277|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159278|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159279|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159280|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159281|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159282|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159283|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159284|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159285|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159490|NCT01328379|B3|Baseline|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
180817|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
159286|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159287|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159288|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159289|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159290|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159291|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159292|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159293|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159294|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159295|NCT01329029|E2|Reported Event|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159296|NCT01329029|E1|Reported Event|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
159297|NCT01328964|B4|Baseline|Total|Total of all reporting groups
159298|NCT01328964|B3|Baseline|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
159299|NCT01328964|B2|Baseline|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
159300|NCT01328964|B1|Baseline|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159301|NCT01328964|P3|Participant Flow|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
159302|NCT01328964|P2|Participant Flow|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
159303|NCT01328964|P1|Participant Flow|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159304|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
159305|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159306|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
159307|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159308|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
159309|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159310|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
159311|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159312|NCT01328964|E3|Reported Event|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
159313|NCT01328964|E2|Reported Event|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
159314|NCT01328964|E1|Reported Event|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
159315|NCT01328951|B3|Baseline|Total|Total of all reporting groups
159316|NCT01328951|B2|Baseline|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159317|NCT01328951|B1|Baseline|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159378|NCT01328756|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159491|NCT01328379|B2|Baseline|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159318|NCT01328951|P2|Participant Flow|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159319|NCT01328951|P1|Participant Flow|Late Erlotinib|Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159320|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159321|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159322|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159323|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159324|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159325|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159326|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159327|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159328|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159329|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159330|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159331|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159332|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159333|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159334|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159335|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159411|NCT01328574|E1|Reported Event|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159492|NCT01328379|B1|Baseline|Placebo|placebo, twice daily
159493|NCT01328379|P3|Participant Flow|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159336|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159337|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
159338|NCT01328951|E4|Reported Event|Second-Line Chemotherapy (Early Erlotinib)|Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
159339|NCT01328951|E3|Reported Event|Second-Line Erlotinib (Late Erlotinib)|Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
159340|NCT01328951|E2|Reported Event|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159341|NCT01328951|E1|Reported Event|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
159342|NCT01328782|B4|Baseline|Total|Total of all reporting groups
159343|NCT01328782|B3|Baseline|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159344|NCT01328782|B2|Baseline|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159345|NCT01328782|B1|Baseline|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159346|NCT01328782|P3|Participant Flow|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159347|NCT01328782|P2|Participant Flow|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159348|NCT01328782|P1|Participant Flow|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159349|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159350|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159351|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159352|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159353|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159354|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159355|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159356|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159357|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159358|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159359|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159360|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159361|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159362|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159363|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159364|NCT01328782|E3|Reported Event|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
159365|NCT01328782|E2|Reported Event|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
159366|NCT01328782|E1|Reported Event|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
159367|NCT01328769|B3|Baseline|Total|Total of all reporting groups
159368|NCT01328769|B2|Baseline|Placebo|Matching placebo dose 80mg once daily
159369|NCT01328769|B1|Baseline|Febuxostat|80mg daily
159379|NCT01328756|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.~At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period."
159380|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159381|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159382|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159383|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159384|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159385|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159386|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159387|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159388|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159389|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159390|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159391|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159392|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159393|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
159394|NCT01328756|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
159395|NCT01328717|B1|Baseline|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
159396|NCT01328717|P1|Participant Flow|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
159397|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
159398|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
159399|NCT01328717|E1|Reported Event|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
159400|NCT01328574|B1|Baseline|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159401|NCT01328574|P1|Participant Flow|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159402|NCT01328574|O5|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events."
159403|NCT01328574|O4|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events."
159404|NCT01328574|O3|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events."
159405|NCT01328574|O2|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events."
159406|NCT01328574|O1|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - All Grades|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously~Adverse events grades 1-4 (mild, moderate, severe and life threatening)."
159407|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159408|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159409|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159410|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
159616|NCT01328080|B1|Baseline|Targeted UV-B|
159412|NCT01328444|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
159413|NCT01328444|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159414|NCT01328444|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159415|NCT01328444|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159416|NCT01328444|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159417|NCT01328444|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
159418|NCT01328444|P1|Participant Flow|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159419|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159420|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159421|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159422|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159423|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159424|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159425|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159426|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159427|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159428|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159429|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159430|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159431|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159432|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159433|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159434|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159435|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159436|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159437|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159438|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159439|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159440|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159441|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159442|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159443|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159444|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159445|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159446|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159447|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159448|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159449|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159450|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159451|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159452|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159453|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159454|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159455|NCT01328444|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
159456|NCT01328444|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
159457|NCT01328444|E4|Reported Event|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
159458|NCT01328444|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
159459|NCT01328444|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
159460|NCT01328444|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
159461|NCT01328431|B3|Baseline|Total|Total of all reporting groups
159767|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159462|NCT01328431|B2|Baseline|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
159463|NCT01328431|B1|Baseline|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
159464|NCT01328431|P2|Participant Flow|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
159465|NCT01328431|P1|Participant Flow|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
159466|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
159467|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
159468|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
159469|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
159470|NCT01328431|E2|Reported Event|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
159471|NCT01328431|E1|Reported Event|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
159472|NCT01328405|B3|Baseline|Total|Total of all reporting groups
159473|NCT01328405|B2|Baseline|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159474|NCT01328405|B1|Baseline|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159475|NCT01328405|P2|Participant Flow|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159476|NCT01328405|P1|Participant Flow|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159477|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159478|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159479|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159480|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159481|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159482|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159483|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159484|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159485|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159486|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159487|NCT01328405|E2|Reported Event|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
159488|NCT01328405|E1|Reported Event|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
159489|NCT01328379|B4|Baseline|Total|Total of all reporting groups
159494|NCT01328379|P2|Participant Flow|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159495|NCT01328379|P1|Participant Flow|Placebo|placebo, twice daily
159496|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159497|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159498|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159499|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159500|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159501|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159502|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159503|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159504|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159505|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159506|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159507|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159508|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159509|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159510|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159511|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159512|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159513|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159514|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159515|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159516|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
159517|NCT01328379|E3|Reported Event|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
159518|NCT01328379|E2|Reported Event|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
159519|NCT01328379|E1|Reported Event|Placebo|placebo, twice daily
159520|NCT01328366|B1|Baseline|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159521|NCT01328366|P1|Participant Flow|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159522|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159523|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159524|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159525|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159526|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159527|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159528|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159529|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159530|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159531|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159532|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159533|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159534|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159768|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159535|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159536|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159537|NCT01328366|E1|Reported Event|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
159538|NCT01328184|B1|Baseline|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
159539|NCT01328184|P1|Participant Flow|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
159540|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159541|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159542|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159543|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159544|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159545|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159546|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159547|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159548|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159549|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159550|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159551|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159552|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159553|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159554|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159555|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159556|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159557|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159558|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159559|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159560|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159561|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159562|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159563|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159564|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159565|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159566|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159567|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159568|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159569|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159570|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159571|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159572|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159573|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159574|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159575|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
159576|NCT01328184|E2|Reported Event|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
159577|NCT01328184|E1|Reported Event|Microgynon|One tablet of Microgynon once daily for 14 days.
159578|NCT01328158|B1|Baseline|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159579|NCT01328158|P1|Participant Flow|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159580|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159581|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159582|NCT01328158|O3|Outcome|Lopinavir/Ritonavir: Baseline CDC Category Unknown|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159769|NCT01327547|E2|Reported Event|Placebo|Participants who received placebo in combination with HAART
159583|NCT01328158|O2|Outcome|Lopinavir/Ritonavir: Baseline CDC Category C|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159584|NCT01328158|O1|Outcome|Lopinavir/Ritonavir: Baseline CDC Category A|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159585|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159586|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159587|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159588|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159589|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159590|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159591|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159592|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159593|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159594|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159595|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159596|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159597|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159598|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159599|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159600|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159601|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159602|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159603|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159604|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159605|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159606|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159607|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159608|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159609|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159610|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159611|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159612|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159613|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159614|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159615|NCT01328158|E1|Reported Event|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
159617|NCT01328080|P1|Participant Flow|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
159618|NCT01328080|O1|Outcome|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
159619|NCT01328080|E1|Reported Event|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
159620|NCT01328054|B1|Baseline|Placebo and Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159621|NCT01328054|P2|Participant Flow|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159622|NCT01328054|P1|Participant Flow|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159623|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159624|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159625|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159626|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159627|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159628|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159629|NCT01328054|O1|Outcome|Placebo/ Lapatinib|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159630|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159631|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
159632|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159633|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159634|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159635|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159636|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
159637|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159638|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159639|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159640|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159641|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159642|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159643|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159644|NCT01328054|E2|Reported Event|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
159645|NCT01328054|E1|Reported Event|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
159646|NCT01328041|B1|Baseline|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159647|NCT01328041|P1|Participant Flow|Dolutegravir 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
159648|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159649|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159650|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159651|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159652|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159653|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159654|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159655|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159656|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159657|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159658|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159659|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159660|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159661|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159662|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159663|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159664|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159665|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159666|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159667|NCT01328041|E1|Reported Event|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
159668|NCT01327989|B1|Baseline|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
159669|NCT01327989|P1|Participant Flow|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159670|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159671|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159672|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159673|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159674|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159675|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159676|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159677|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159678|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
159679|NCT01327989|E1|Reported Event|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
159680|NCT01327976|B3|Baseline|Total|Total of all reporting groups
159681|NCT01327976|B2|Baseline|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
159682|NCT01327976|B1|Baseline|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
159683|NCT01327976|P2|Participant Flow|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
159684|NCT01327976|P1|Participant Flow|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
159685|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
159686|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
159687|NCT01327976|O2|Outcome|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBlocTherapy"
159688|NCT01327976|O1|Outcome|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy"
159689|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
159690|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
159709|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159691|NCT01327976|E2|Reported Event|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
159692|NCT01327976|E1|Reported Event|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy."
159693|NCT01327703|B1|Baseline|Entire Study Population|Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.
159694|NCT01327703|P2|Participant Flow|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
159695|NCT01327703|P1|Participant Flow|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
159696|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
159697|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
159698|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
159699|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
159700|NCT01327703|O2|Outcome|Kreon®, First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
159701|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
159702|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159703|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159704|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159705|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159706|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159707|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159708|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159756|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159710|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159711|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159712|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159713|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159714|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159715|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159716|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159717|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159718|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159719|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159720|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159721|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159722|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159723|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159724|NCT01327703|E2|Reported Event|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159725|NCT01327703|E1|Reported Event|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
159726|NCT01327599|B1|Baseline|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159727|NCT01327599|P1|Participant Flow|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159728|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159729|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159730|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159731|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159732|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159733|NCT01327599|E1|Reported Event|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
159734|NCT01327547|B3|Baseline|Total|Total of all reporting groups
159735|NCT01327547|B2|Baseline|Placebo|Participants who received placebo in combination with HAART
159736|NCT01327547|B1|Baseline|Maraviroc|Participants who received maraviroc in combination with HAART
159737|NCT01327547|P2|Participant Flow|Placebo|Participants who received placebo in combination with HAART
159738|NCT01327547|P1|Participant Flow|Maraviroc|Participants who received maraviroc in combination with HAART
159739|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159740|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159741|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159742|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159743|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159744|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159745|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159746|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159747|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159748|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159749|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159750|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159751|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159752|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159753|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159754|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
159755|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
159770|NCT01327547|E1|Reported Event|Maraviroc|Participants who received maraviroc in combination with HAART
159771|NCT01327508|B3|Baseline|Total|Total of all reporting groups
159772|NCT01327508|B2|Baseline|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
159773|NCT01327508|B1|Baseline|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
159774|NCT01327508|P2|Participant Flow|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
159775|NCT01327508|P1|Participant Flow|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
159776|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
159777|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
159778|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
159779|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
159780|NCT01327508|E2|Reported Event|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
159781|NCT01327508|E1|Reported Event|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
159782|NCT01327482|B1|Baseline|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
159783|NCT01327482|P1|Participant Flow|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
159784|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
159785|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
159786|NCT01327482|E1|Reported Event|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
159787|NCT01327339|B1|Baseline|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
159788|NCT01327339|P1|Participant Flow|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
159789|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
159790|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
159791|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
159792|NCT01327339|E1|Reported Event|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
159793|NCT01327313|B5|Baseline|Total|Total of all reporting groups
159794|NCT01327313|B4|Baseline|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159795|NCT01327313|B3|Baseline|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159796|NCT01327313|B2|Baseline|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159797|NCT01327313|B1|Baseline|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159798|NCT01327313|P4|Participant Flow|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159799|NCT01327313|P3|Participant Flow|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159800|NCT01327313|P2|Participant Flow|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159801|NCT01327313|P1|Participant Flow|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159802|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159803|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159804|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159805|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159806|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159807|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159808|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159809|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159810|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159811|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159812|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159813|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159814|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159815|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159816|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159817|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159818|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159819|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159820|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159821|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159822|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159823|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159824|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159825|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159826|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159827|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159828|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159829|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159830|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159831|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159832|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159833|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159834|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159835|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159836|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159837|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159838|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159839|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159840|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159841|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159842|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159843|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159844|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159845|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159846|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159847|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159848|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159849|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159850|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159851|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159852|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159853|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159854|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159855|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159856|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159857|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159858|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159859|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159860|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159861|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159862|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159863|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159864|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159865|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159866|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159867|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159868|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159869|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159870|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159871|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159872|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159873|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159874|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159875|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159876|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159877|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159878|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159879|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159880|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159881|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159882|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159883|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159884|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159885|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159886|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159887|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159888|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159889|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159890|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159891|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159892|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159893|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159894|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159895|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159896|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159897|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159898|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159899|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159900|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159901|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159902|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159903|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159904|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159905|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159906|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159907|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159908|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159909|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159910|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159911|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159912|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159913|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159914|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159915|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159916|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159917|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159918|NCT01327313|E4|Reported Event|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159919|NCT01327313|E3|Reported Event|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159920|NCT01327313|E2|Reported Event|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159921|NCT01327313|E1|Reported Event|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
159922|NCT01327300|B1|Baseline|All Study Participants|All participants were randomized to receive both mesalamine and placebo.
159923|NCT01327300|P2|Participant Flow|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
159924|NCT01327300|P1|Participant Flow|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
159925|NCT01327300|O2|Outcome|Placebo|"This group received the placebo for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.~Two patients in this cross-over study did not provide a 24 hour urine sample needed to obtain the lactulose /mannitol ratio."
159926|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
159927|NCT01327300|O2|Outcome|Placebo|This group will receive the Placebo for 12 weeks. Comparison of the change in HADS score after 12 weeks of placebo is made to baseline score.
159928|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks . Comparison of the change in HADS score after 12 weeks of mesalamine is made to baseline score.
159929|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
159930|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
159931|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Values reported at the baseline FBDSI score minus the 12 week FBDSI score with placebo."
159932|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Data is reported as baseline value minus 12 week mean FBDSI value with mesalamine."
159933|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation"
159934|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation."
159935|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks."
159936|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks
159937|NCT01327300|E2|Reported Event|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
159938|NCT01327300|E1|Reported Event|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
159939|NCT01327053|B3|Baseline|Total|Total of all reporting groups
159940|NCT01327053|B2|Baseline|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159941|NCT01327053|B1|Baseline|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159942|NCT01327053|P2|Participant Flow|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159943|NCT01327053|P1|Participant Flow|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159944|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159945|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159946|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159947|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159948|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159949|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159950|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159951|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159952|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159953|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159954|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159955|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159956|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159957|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159958|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159959|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159960|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159961|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159962|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159963|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159964|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159965|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159966|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159967|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159968|NCT01327053|E2|Reported Event|LDE225 800 mg qd|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159969|NCT01327053|E1|Reported Event|LDE225 200 mg qd|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
159970|NCT01326962|B1|Baseline|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
159971|NCT01326962|P1|Participant Flow|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
180818|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
159972|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159973|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159974|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159975|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159976|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159977|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159978|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159979|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159980|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159981|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159982|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159983|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159984|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
159985|NCT01326962|E1|Reported Event|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
159986|NCT01326910|B3|Baseline|Total|Total of all reporting groups
159987|NCT01326910|B2|Baseline|19306-137|Marketed Topical cream applied twice daily (or as needed)
159988|NCT01326910|B1|Baseline|19306-127|Experimental Topical cream applied twice daily (or as needed)
159989|NCT01326910|P2|Participant Flow|19306-137|Marketed Topical cream applied twice daily (or as needed)
159990|NCT01326910|P1|Participant Flow|19306-127|Experimental Topical cream applied twice daily (or as needed)
159991|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
159992|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
159993|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
159994|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
159995|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
159996|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
159997|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
159998|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
159999|NCT01326910|E2|Reported Event|19306-137|Marketed Topical cream applied twice daily (or as needed)
160000|NCT01326910|E1|Reported Event|19306-127|Experimental Topical cream applied twice daily (or as needed)
160001|NCT01326845|B3|Baseline|Total|Total of all reporting groups
160002|NCT01326845|B2|Baseline|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160003|NCT01326845|B1|Baseline|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160004|NCT01326845|P2|Participant Flow|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160005|NCT01326845|P1|Participant Flow|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160006|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160007|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160008|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160009|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160010|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160011|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160012|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160013|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160014|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160015|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160016|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160017|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160018|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160019|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160356|NCT01324882|O1|Outcome|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
160020|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160021|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160022|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
160023|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
160024|NCT01326845|E2|Reported Event|ICL pm|ICL pm
160025|NCT01326845|E1|Reported Event|ICL am|ICL am
160026|NCT01326533|B3|Baseline|Total|Total of all reporting groups
160027|NCT01326533|B2|Baseline|Placebo|Placebo daily
160028|NCT01326533|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400 mg daily
160029|NCT01326533|P2|Participant Flow|Placebo|13 weeks of placebo PO
160030|NCT01326533|P1|Participant Flow|Hydroxychloroquine|13 weeks of hydroxychloroquine sulfate PO 400 mg/day
160031|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
160032|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
160033|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
160034|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
160035|NCT01326533|E2|Reported Event|Placebo|Placebo PO
160036|NCT01326533|E1|Reported Event|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400mg/day
160037|NCT01326026|B3|Baseline|Total|Total of all reporting groups
160038|NCT01326026|B2|Baseline|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160039|NCT01326026|B1|Baseline|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160040|NCT01326026|P2|Participant Flow|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160041|NCT01326026|P1|Participant Flow|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160042|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160043|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160044|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160045|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160046|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160047|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160048|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160049|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160050|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160116|NCT01325623|B1|Baseline|VNS Therapy (Safety Population)|The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
180819|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
160051|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160052|NCT01326026|E2|Reported Event|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
160053|NCT01326026|E1|Reported Event|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
160054|NCT01325870|B4|Baseline|Total|Total of all reporting groups
160055|NCT01325870|B3|Baseline|S-CPR|S-CPR: standard manual CPR
160056|NCT01325870|B2|Baseline|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160057|NCT01325870|B1|Baseline|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160058|NCT01325870|P3|Participant Flow|S-CPR|S-CPR: standard manual CPR
160059|NCT01325870|P2|Participant Flow|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160060|NCT01325870|P1|Participant Flow|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160061|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
160062|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160063|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160064|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
160065|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160066|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160067|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
160068|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160069|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160070|NCT01325870|E3|Reported Event|S-CPR|S-CPR: standard manual CPR
160071|NCT01325870|E2|Reported Event|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
160072|NCT01325870|E1|Reported Event|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
160073|NCT01325792|B1|Baseline|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
160074|NCT01325792|P1|Participant Flow|Single-staged Open Complex Ventral Incisional Hernia Repair|GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
160075|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
160076|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
160077|NCT01325792|E1|Reported Event|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
160078|NCT01325714|B3|Baseline|Total|Total of all reporting groups
160079|NCT01325714|B2|Baseline|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160080|NCT01325714|B1|Baseline|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160081|NCT01325714|P2|Participant Flow|Arm 2: Enhanced Usual Care|107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD’s level of pain and depression at baseline, 3 months, 6 months, and 12 months
180820|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
160082|NCT01325714|P1|Participant Flow|Arm 1: PAVeD Intervention|106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute “core” sessions (“Recognizing Pain”; “Recognizing and Responding to Pain and Distress”; “Enhancing Communication”; “Making Daily Activities More Pleasant and Enjoyable”) and 2 of 4 elective sessions (“Medical Treatments and Talking to Your Doctor,” “Rest and Relaxation Strategies,” “Communication Problems and Challenges,” and “Increasing Pleasant Activities”), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook.
160083|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160084|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160085|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160086|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160087|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160088|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160089|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160090|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160091|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160092|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160093|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160094|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160095|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160096|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160097|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160098|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160099|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.~N = 102"
160100|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101"
160101|NCT01325714|E2|Reported Event|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
160102|NCT01325714|E1|Reported Event|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
160103|NCT01325701|B3|Baseline|Total|Total of all reporting groups
160104|NCT01325701|B2|Baseline|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160105|NCT01325701|B1|Baseline|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
160106|NCT01325701|P2|Participant Flow|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160107|NCT01325701|P1|Participant Flow|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
160108|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160109|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis
160110|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160111|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
160112|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160113|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
160114|NCT01325701|E2|Reported Event|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
160115|NCT01325701|E1|Reported Event|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
160357|NCT01324882|E2|Reported Event|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
160117|NCT01325623|P1|Participant Flow|Enrolled and Treated Population (Safety Population)|"Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).~In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation."
160118|NCT01325623|O1|Outcome|Percentage Change in Heart Rate|Average percentage change in heart rate from pre-stimulation period to heart rate during VNS Therapy Stimulation, following VNS Therapy Stimulation, and following the black-out period.
160119|NCT01325623|O4|Outcome|Unstimulated Seizures|Unstimulated seizures with =>20% increase in heart rate.
160120|NCT01325623|O3|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
160121|NCT01325623|O2|Outcome|All EMU Stimulated Seizures|Stimulated Seizures with >= 20% increase in heart rate
160122|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
160123|NCT01325623|O5|Outcome|QOLIE-31-P Scores at 24 Months|QOLIE‐31‐P Scores at Follow-Up Visits
160124|NCT01325623|O4|Outcome|QOLIE-31-P Scores at 18 Months|QOLIE‐31‐P Scores at Follow-Up Visits
160125|NCT01325623|O3|Outcome|QOLIE-31-P Scores at 12 Months|QOLIE‐31‐P Scores at Follow-Up Visits
160126|NCT01325623|O2|Outcome|QOLIE-31-P Scores at 6 Months|QOLIE‐31‐P Scores at Follow-Up Visits
160127|NCT01325623|O1|Outcome|QOLIE-31-P Scores at 3 Months|QOLIE‐31‐P Scores at Follow-Up Visits
160128|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
160129|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
160130|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
160131|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
160132|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
160133|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
160134|NCT01325623|O1|Outcome|Proportion of Seizures Ending During Stimulation by Type|EMU seizures that were treated with Automatic Stimulation and ended during the course of the stimulation
160135|NCT01325623|O5|Outcome|SSQ Scores at 24 Months|Change From Baseline at Each Category
160136|NCT01325623|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
160137|NCT01325623|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
160138|NCT01325623|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
160139|NCT01325623|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
160140|NCT01325623|O4|Outcome|Generalized Tonic Clonic Sz|NHS3 Scores at Follow-Up Visits
160141|NCT01325623|O3|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-Up Visits
160142|NCT01325623|O2|Outcome|Complex Partial Seizures (CPS)|NHS3 Scores at Follow-Up Visits
160143|NCT01325623|O1|Outcome|Simple Partial Seizures|NHS3 Scores at Follow-Up Visits
160144|NCT01325623|O2|Outcome|Partial Seizures|"Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (Partial Seizures)~Partial seizures consist of simple partial, complex partial, complex partial with secondarily generalized seizures."
160145|NCT01325623|O1|Outcome|Overall Seizure Responder Rate|Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (All seizure types)
160146|NCT01325623|O2|Outcome|Day 5 EMU or EMU Discharge|Assessment of Device Usability at EMU (Day 5 or Discharge)
160147|NCT01325623|O1|Outcome|Implant/Recovery|Assessment of Device Usability at Implant and Recovery
160148|NCT01325623|O2|Outcome|Latency Analysis of All Seizure Types|The time difference between SDA seizure detection time and the annotated seizure onset time (ALL seizures).
160149|NCT01325623|O1|Outcome|Latency Analysis of Ictal Tachycardia Seizures|"The time difference between SDA detection of the ictal tachycardia seizure and the annotated seizure onset time.~Ictal Tachycardia Seizure is defined as a seizure with an increase from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm."
160150|NCT01325623|O1|Outcome|Beat Detection Sensitivity By Device IPG|"Cardiac R‐Wave Detection Sensitivity Based on Device IPG and ECG Monitor Comparison for 10 second Detection Window. n denotes the total number of patients with available R‐R wave data at the visit time point."
160151|NCT01325623|O1|Outcome|Potential False Positives|Potential False Positives Based on Heart Rate Increase Associated with Seizures by Randomized SDA Setting (AutoStim Per Hour)
160152|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
160153|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
160154|NCT01325623|O3|Outcome|Total|Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data.
160155|NCT01325623|O2|Outcome|Reported by Triple Review|All seizures that occurred during EMU stay and that were identified by triple review post EMU.
160156|NCT01325623|O1|Outcome|Reported by Investigators|All seizures that occurred during EMU stay and that were identified by investigators.
160157|NCT01325623|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table.
160158|NCT01325532|B3|Baseline|Total|Total of all reporting groups
160205|NCT01325350|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160206|NCT01325350|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160207|NCT01325350|P5|Participant Flow|Minoxidil 2% Solution|Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160159|NCT01325532|B2|Baseline|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160160|NCT01325532|B1|Baseline|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160161|NCT01325532|P2|Participant Flow|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160162|NCT01325532|P1|Participant Flow|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160163|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160164|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160165|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160166|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160167|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160208|NCT01325350|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160209|NCT01325350|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160210|NCT01325350|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160602|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160168|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160169|NCT01325532|E2|Reported Event|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
160170|NCT01325532|E1|Reported Event|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
160171|NCT01325493|B3|Baseline|Total|Total of all reporting groups
160172|NCT01325493|B2|Baseline|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160173|NCT01325493|B1|Baseline|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160174|NCT01325493|P2|Participant Flow|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160175|NCT01325493|P1|Participant Flow|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160176|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160177|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160178|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160179|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160180|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160181|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160182|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160183|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160184|NCT01325493|E2|Reported Event|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160185|NCT01325493|E1|Reported Event|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
160186|NCT01325428|B1|Baseline|Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
160211|NCT01325350|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160212|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160213|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160603|NCT01323790|E3|Reported Event|Placebo|
160604|NCT01323790|E2|Reported Event|NKTR-118 25 mg|
160187|NCT01325428|P1|Participant Flow|Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
160188|NCT01325428|O1|Outcome|Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval."
160189|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
160190|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
160191|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
160192|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
160193|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
160194|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
160195|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
160196|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
160197|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
160198|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~The 95% Confidence Interval is Exact Confidence Interval."
160199|NCT01325428|E2|Reported Event|Part B: Afatinib+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
160200|NCT01325428|E1|Reported Event|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
160201|NCT01325350|B6|Baseline|Total|Total of all reporting groups
160202|NCT01325350|B5|Baseline|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160203|NCT01325350|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160204|NCT01325350|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160214|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160215|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160216|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160217|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160218|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160219|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160220|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160221|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160222|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160223|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160224|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160225|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160226|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160227|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160228|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160229|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160230|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160231|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160232|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160233|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160234|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160235|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160236|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160237|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160238|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160239|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160240|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160241|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160242|NCT01325350|E5|Reported Event|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160243|NCT01325350|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160244|NCT01325350|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160245|NCT01325350|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160246|NCT01325350|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160247|NCT01325337|B6|Baseline|Total|Total of all reporting groups
160248|NCT01325337|B5|Baseline|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160249|NCT01325337|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160250|NCT01325337|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160251|NCT01325337|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160252|NCT01325337|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160253|NCT01325337|P5|Participant Flow|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160254|NCT01325337|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160255|NCT01325337|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160256|NCT01325337|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160257|NCT01325337|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160258|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160259|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160260|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160261|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160262|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160263|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160264|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160265|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160266|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160267|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160268|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160269|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160270|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160271|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160272|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160273|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160274|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160275|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160276|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160277|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160278|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160279|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160280|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160281|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160282|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160283|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160284|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160285|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160286|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160287|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160288|NCT01325337|E5|Reported Event|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
160289|NCT01325337|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
160290|NCT01325337|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
160291|NCT01325337|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
160355|NCT01324882|O2|Outcome|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
160292|NCT01325337|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
160293|NCT01325311|B3|Baseline|Total|Total of all reporting groups
160294|NCT01325311|B2|Baseline|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160295|NCT01325311|B1|Baseline|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160296|NCT01325311|P2|Participant Flow|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160297|NCT01325311|P1|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160298|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160299|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160300|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160301|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160302|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160303|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160304|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160305|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160306|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160307|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160308|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160309|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160310|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160311|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160312|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160313|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160314|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160315|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160316|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160317|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160318|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160319|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160320|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160321|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160322|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160323|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160324|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160325|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160326|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160327|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160328|NCT01325311|E2|Reported Event|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
160329|NCT01325311|E1|Reported Event|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
160330|NCT01325181|B3|Baseline|Total|Total of all reporting groups
160331|NCT01325181|B2|Baseline|Ranibizumab|
160332|NCT01325181|B1|Baseline|Low-fluence PDT|
160333|NCT01325181|P2|Participant Flow|Ranibizumab|
160334|NCT01325181|P1|Participant Flow|Low-fluence PDT|
160335|NCT01325181|O2|Outcome|Ranibizumab|
160336|NCT01325181|O1|Outcome|Low-fluence PDT|
160337|NCT01325181|E2|Reported Event|Ranibizumab|
160338|NCT01325181|E1|Reported Event|Low-fluence PDT|
160339|NCT01324947|B1|Baseline|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160340|NCT01324947|P1|Participant Flow|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160341|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160342|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160343|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity"
160344|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160345|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160346|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160347|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity"
160348|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160349|NCT01324947|E1|Reported Event|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
160350|NCT01324882|B3|Baseline|Total|Total of all reporting groups
160351|NCT01324882|B2|Baseline|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
160352|NCT01324882|B1|Baseline|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
160353|NCT01324882|P2|Participant Flow|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
160354|NCT01324882|P1|Participant Flow|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
160358|NCT01324882|E1|Reported Event|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
160359|NCT01324687|B3|Baseline|Total|Total of all reporting groups
160360|NCT01324687|B2|Baseline|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
160361|NCT01324687|B1|Baseline|Control|Group without access to telemedicine in the home for acute care issues.
160362|NCT01324687|P2|Participant Flow|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
160363|NCT01324687|P1|Participant Flow|Control|Group without access to telemedicine in the home for acute care issues.
160364|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
160365|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
160366|NCT01324687|E2|Reported Event|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
160367|NCT01324687|E1|Reported Event|Control|Group without access to telemedicine in the home for acute care issues.
160368|NCT01324440|B3|Baseline|Total|Total of all reporting groups
160369|NCT01324440|B2|Baseline|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160370|NCT01324440|B1|Baseline|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160371|NCT01324440|P2|Participant Flow|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160372|NCT01324440|P1|Participant Flow|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160373|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160374|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160375|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160376|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160377|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160378|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160379|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160380|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160381|NCT01324440|E2|Reported Event|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
160382|NCT01324440|E1|Reported Event|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
160383|NCT01324401|B3|Baseline|Total|Total of all reporting groups
160384|NCT01324401|B2|Baseline|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
160385|NCT01324401|B1|Baseline|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
160386|NCT01324401|P2|Participant Flow|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
160387|NCT01324401|P1|Participant Flow|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
160388|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
160389|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
160390|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
160391|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
160448|NCT01324323|O1|Outcome|Romidepsin Day 1|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.~Rifampin 600 mg oral once daily on Days 4-8"
160392|NCT01324401|E2|Reported Event|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
160393|NCT01324401|E1|Reported Event|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
160394|NCT01324388|B4|Baseline|Total|Total of all reporting groups
160395|NCT01324388|B3|Baseline|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
160396|NCT01324388|B2|Baseline|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160397|NCT01324388|B1|Baseline|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160398|NCT01324388|P4|Participant Flow|Part 2: LY2189265 + Metoprolol First, Then LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study)."
160399|NCT01324388|P3|Participant Flow|Part 2: LY2189265 First, Then LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study)."
160400|NCT01324388|P2|Participant Flow|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160401|NCT01324388|P1|Participant Flow|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160402|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 ; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
160403|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
160404|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160405|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160406|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
160407|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
160491|NCT01324128|E3|Reported Event|PA21-1 (LD) Stage 2|PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.
160408|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160409|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160410|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160411|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160412|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160413|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160414|NCT01324388|E5|Reported Event|Part 2: LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.~Time frame: Day 5 to end of Treatment 2"
160415|NCT01324388|E4|Reported Event|Part 2: Metoprolol|"Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.~Time frame: Days 1 to 4 of Treatment 2"
160416|NCT01324388|E3|Reported Event|Part 2: LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.~Time frame: Treatment 1"
160417|NCT01324388|E2|Reported Event|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160418|NCT01324388|E1|Reported Event|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
160419|NCT01324349|B3|Baseline|Total|Total of all reporting groups
160420|NCT01324349|B2|Baseline|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
160421|NCT01324349|B1|Baseline|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160422|NCT01324349|P2|Participant Flow|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
160423|NCT01324349|P1|Participant Flow|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160424|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
160425|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160426|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
160427|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160428|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
160429|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160430|NCT01324349|E2|Reported Event|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
160431|NCT01324349|E1|Reported Event|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
160432|NCT01324323|B1|Baseline|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
160433|NCT01324323|P1|Participant Flow|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
160434|NCT01324323|O1|Outcome|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Days 1 and 8. Rifampin 600 mg oral once daily on Days 4-8
160435|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
160436|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
160437|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
160438|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
160439|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
160440|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
160441|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
160442|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
160443|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8
160444|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
160445|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8.
160446|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1
160447|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
160449|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8.
160450|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
160451|NCT01324323|E1|Reported Event|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8 and Rifampin 600 mg oral once daily on Days 4-8.
160452|NCT01324310|B1|Baseline|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Ketoconazole 400 mg oral once daily on Days 4-8"
160453|NCT01324310|P1|Participant Flow|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8~Ketoconazole 400 mg oral once daily on Days 4-8"
160454|NCT01324310|O1|Outcome|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
160455|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160456|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160457|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160458|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160459|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160460|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160461|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160462|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160463|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160464|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160465|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160466|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160467|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160468|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160469|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
160470|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
160471|NCT01324310|E1|Reported Event|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
160472|NCT01324271|B1|Baseline|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
160473|NCT01324271|P2|Participant Flow|Tympanostomy Tube Placement (Study Cohort)|Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
160474|NCT01324271|P1|Participant Flow|Tympanostomy Tube Placement (Lead-In Procedures)|"Acclarent Tympanostomy Tube Delivery system (TTDS):~Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room."
160475|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
160476|NCT01324271|O1|Outcome|Tube Placement Using the TTDS in Office/Clinic Setting|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
160477|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
160478|NCT01324271|E1|Reported Event|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
160479|NCT01324128|B3|Baseline|Total|Total of all reporting groups
160480|NCT01324128|B2|Baseline|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
160481|NCT01324128|B1|Baseline|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
160482|NCT01324128|P4|Participant Flow|PA21-1 (LD) Stage 2|PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.
160483|NCT01324128|P3|Participant Flow|PA21 (MD) Stage 2|PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1
160484|NCT01324128|P2|Participant Flow|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
160485|NCT01324128|P1|Participant Flow|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
160486|NCT01324128|O2|Outcome|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
160487|NCT01324128|O1|Outcome|PA21 (2.5 g Tablet) Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
160488|NCT01324128|O2|Outcome|PA21-1 (LD) Stage 2|PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2
160489|NCT01324128|O1|Outcome|PA21 (MD) Stage 2|PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
160490|NCT01324128|E4|Reported Event|PA21 (MD) Stage 2|PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
160605|NCT01323790|E1|Reported Event|NKTR-118 12.5 mg|
160492|NCT01324128|E2|Reported Event|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
160493|NCT01324128|E1|Reported Event|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
160494|NCT01324102|B3|Baseline|Total|Total of all reporting groups
160495|NCT01324102|B2|Baseline|Wait List Control|Wait List control: The wait list control did not receive an intervention.
160496|NCT01324102|B1|Baseline|Yoga Therapy Intervention|Intervention: Yoga therapy was 8 week class for two times per week
160497|NCT01324102|P2|Participant Flow|Wait List Control|Wait List control received no intervention for 8 weeks, then joined the yoga group
160498|NCT01324102|P1|Participant Flow|Yoga Therapy Intervention|"Intervention~Yoga therapy received an 8 week 2x weekly Yoga therapy class."
160499|NCT01324102|O2|Outcome|Post Group Values|Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
160500|NCT01324102|O1|Outcome|Pre Group Values|Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
160501|NCT01324102|E3|Reported Event|Wait List on Yoga Therapy|"Received yoga therapy after an 8 week wait.~No participants were hospitalized."
160502|NCT01324102|E2|Reported Event|Wait List|"Received no yoga therapy for 8 weeks while the intervention group received yoga therapy~One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia."
160503|NCT01324102|E1|Reported Event|Yoga Therapy|"Received yoga therapy.~One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza."
160504|NCT01323998|B6|Baseline|Total|Total of all reporting groups
160505|NCT01323998|B5|Baseline|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160506|NCT01323998|B4|Baseline|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160507|NCT01323998|B3|Baseline|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160508|NCT01323998|B2|Baseline|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160509|NCT01323998|B1|Baseline|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160510|NCT01323998|P5|Participant Flow|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160511|NCT01323998|P4|Participant Flow|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160512|NCT01323998|P3|Participant Flow|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160513|NCT01323998|P2|Participant Flow|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160514|NCT01323998|P1|Participant Flow|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery
160515|NCT01323998|O5|Outcome|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160516|NCT01323998|O4|Outcome|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160517|NCT01323998|O3|Outcome|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160546|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160518|NCT01323998|O2|Outcome|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160519|NCT01323998|O1|Outcome|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160520|NCT01323998|E5|Reported Event|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160521|NCT01323998|E4|Reported Event|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160522|NCT01323998|E3|Reported Event|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160523|NCT01323998|E2|Reported Event|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160524|NCT01323998|E1|Reported Event|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
160525|NCT01323920|B1|Baseline|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160526|NCT01323920|P1|Participant Flow|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160527|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160528|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160529|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160530|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160531|NCT01323920|E1|Reported Event|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
160532|NCT01323855|B6|Baseline|Total|Total of all reporting groups
160533|NCT01323855|B5|Baseline|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160534|NCT01323855|B4|Baseline|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160535|NCT01323855|B3|Baseline|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160536|NCT01323855|B2|Baseline|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160537|NCT01323855|B1|Baseline|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160538|NCT01323855|P5|Participant Flow|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160539|NCT01323855|P4|Participant Flow|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160540|NCT01323855|P3|Participant Flow|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160541|NCT01323855|P2|Participant Flow|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160542|NCT01323855|P1|Participant Flow|Part 1: Severe Renal Impairment|Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160543|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160544|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160545|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160601|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160547|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160548|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160549|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160550|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160551|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160552|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160553|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160554|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160555|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160556|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160557|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160558|NCT01323855|E5|Reported Event|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160559|NCT01323855|E4|Reported Event|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160560|NCT01323855|E3|Reported Event|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160561|NCT01323855|E2|Reported Event|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160562|NCT01323855|E1|Reported Event|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
160563|NCT01323790|B4|Baseline|Total|Total of all reporting groups
160564|NCT01323790|B3|Baseline|Placebo|Placebo QD, oral treatment
160565|NCT01323790|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160566|NCT01323790|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160567|NCT01323790|P3|Participant Flow|Placebo|Placebo QD, oral treatment
160568|NCT01323790|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160569|NCT01323790|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160570|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160571|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160572|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160573|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160574|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160575|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160576|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160577|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160578|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160579|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160580|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160581|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160582|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160583|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160584|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160585|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160586|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160587|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160588|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160589|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160590|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160591|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160592|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160593|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160594|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160595|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160596|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160597|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160598|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
160599|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
160600|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
160607|NCT01323673|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160608|NCT01323673|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160609|NCT01323673|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160610|NCT01323673|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160611|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160612|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160613|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160614|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160615|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160616|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160617|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160618|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160619|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160620|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160621|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160622|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160623|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160624|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160625|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160626|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160627|NCT01323673|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
160628|NCT01323673|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
160629|NCT01323660|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
160630|NCT01323660|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160631|NCT01323660|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160632|NCT01323660|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
160633|NCT01323660|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160634|NCT01323660|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
160787|NCT01323192|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160635|NCT01323660|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
160636|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160637|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160638|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160639|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160640|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160641|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160642|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160643|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160644|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160645|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160646|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160647|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160648|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160649|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160650|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160651|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160652|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160653|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160654|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160655|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160656|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160657|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160658|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160659|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160660|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160661|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160662|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160663|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160664|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160665|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160666|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160667|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160668|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160669|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160670|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160671|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160672|NCT01323660|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
160673|NCT01323660|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
160674|NCT01323660|E4|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
160675|NCT01323660|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
160676|NCT01323660|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
160677|NCT01323660|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
160678|NCT01323647|B3|Baseline|Total|Total of all reporting groups
160679|NCT01323647|B2|Baseline|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
160680|NCT01323647|B1|Baseline|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160681|NCT01323647|P2|Participant Flow|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
160682|NCT01323647|P1|Participant Flow|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160683|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
180821|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
160684|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160685|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160686|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160687|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160688|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
160689|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160690|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160691|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
160692|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160693|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160694|NCT01323647|E2|Reported Event|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
160695|NCT01323647|E1|Reported Event|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
160696|NCT01323634|B3|Baseline|Total|Total of all reporting groups
160697|NCT01323634|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160698|NCT01323634|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160699|NCT01323634|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160700|NCT01323634|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160701|NCT01323634|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
160702|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160703|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160704|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160705|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160706|NCT01323634|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160735|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
160707|NCT01323634|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160708|NCT01323621|B3|Baseline|Total|Total of all reporting groups
160709|NCT01323621|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160710|NCT01323621|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160711|NCT01323621|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160712|NCT01323621|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160713|NCT01323621|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, Ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
160714|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160715|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160716|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160717|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160718|NCT01323621|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
160719|NCT01323621|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
160720|NCT01323595|B3|Baseline|Total|Total of all reporting groups
160721|NCT01323595|B2|Baseline|Sugar Pill|"Sugar pill for 6 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
160722|NCT01323595|B1|Baseline|Celecoxib|"Celecoxib will be given for 6 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
160723|NCT01323595|P2|Participant Flow|Sugar Pill|"Sugar pill for 5 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
160724|NCT01323595|P1|Participant Flow|Celecoxib|"Celecoxib will be given for 5 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
160725|NCT01323595|O2|Outcome|Celecoxib|
160726|NCT01323595|O1|Outcome|Placebo Treatment|
160727|NCT01323595|E2|Reported Event|Celecoxib|
160728|NCT01323595|E1|Reported Event|Placebo Treatment|
160729|NCT01323582|B3|Baseline|Total|Total of all reporting groups
160730|NCT01323582|B2|Baseline|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160731|NCT01323582|B1|Baseline|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160732|NCT01323582|P2|Participant Flow|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160733|NCT01323582|P1|Participant Flow|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160734|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
160786|NCT01323192|B1|Baseline|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160736|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
160737|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
160738|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160739|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160740|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160741|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160742|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160743|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160744|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
160745|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
160746|NCT01323582|E2|Reported Event|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
160747|NCT01323582|E1|Reported Event|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
160748|NCT01323478|B1|Baseline|Vortioxetine 15 or 20 mg/Day|
160749|NCT01323478|P1|Participant Flow|Vortioxetine 15 or 20 mg/Day|
160750|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160751|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160752|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160753|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160754|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160755|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160756|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160757|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160758|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160759|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
160760|NCT01323478|E1|Reported Event|Vortioxetine 15 or 20 mg/Day|
160761|NCT01323270|B3|Baseline|Total|Total of all reporting groups
160762|NCT01323270|B2|Baseline|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160763|NCT01323270|B1|Baseline|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160764|NCT01323270|P2|Participant Flow|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160765|NCT01323270|P1|Participant Flow|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160766|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160767|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160768|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160769|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160770|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160771|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160772|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160773|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160774|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month
160775|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160776|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160777|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160778|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160779|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160780|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160781|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160782|NCT01323270|E2|Reported Event|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
160783|NCT01323270|E1|Reported Event|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
160784|NCT01323192|B3|Baseline|Total|Total of all reporting groups
160785|NCT01323192|B2|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
180822|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
160788|NCT01323192|P1|Participant Flow|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160789|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160790|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160791|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160792|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160793|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160794|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160795|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160796|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160797|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160798|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160799|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160800|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160801|NCT01323192|E2|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
160802|NCT01323192|E1|Reported Event|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
160803|NCT01323140|B1|Baseline|Treatment|
160804|NCT01323140|P1|Participant Flow|Treatment|
160805|NCT01323140|O1|Outcome|Treatment|As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
160806|NCT01323140|E1|Reported Event|Treatment|
160807|NCT01323010|B3|Baseline|Total|Total of all reporting groups
160808|NCT01323010|B2|Baseline|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160809|NCT01323010|B1|Baseline|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160810|NCT01323010|P2|Participant Flow|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160811|NCT01323010|P1|Participant Flow|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160812|NCT01323010|O3|Outcome|Arg16Arg Patients|Patients carrying the Arg16Arg genotype
160813|NCT01323010|O2|Outcome|Gly16Gly Patients|Patients carrying the Gly16Gly genotype
160814|NCT01323010|O1|Outcome|Arg16Gly Patients|Patients carrying the Arg16Gly genotype
160815|NCT01323010|O2|Outcome|No Rhinovirus Detected|patients with no rhinovirus detected by PCR
160816|NCT01323010|O1|Outcome|Rhinovirus Detected|patients with rhinovirus detected by PCR
160817|NCT01323010|O2|Outcome|No Virus Detected|patients with no virus detected by PCR
160818|NCT01323010|O1|Outcome|Virus Detected|patients with any virus detected by PCR
160819|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160820|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160821|NCT01323010|O2|Outcome|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160822|NCT01323010|O1|Outcome|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160823|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160824|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160825|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160826|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160827|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160828|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160829|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160830|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160831|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160832|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160833|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160834|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160835|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160836|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160837|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160838|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160839|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160840|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160841|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160842|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160843|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160844|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160845|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160846|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160847|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160848|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160928|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160849|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160850|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160851|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160852|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160853|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was individualized according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160854|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160855|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160856|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160857|NCT01323010|E2|Reported Event|Control Group|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
160858|NCT01323010|E1|Reported Event|Experimental Group|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
160859|NCT01322971|B3|Baseline|Total|Total of all reporting groups
160860|NCT01322971|B2|Baseline|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160861|NCT01322971|B1|Baseline|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160862|NCT01322971|P2|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160863|NCT01322971|P1|Participant Flow|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160864|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160865|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160866|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160867|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160868|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160869|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160870|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160871|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160872|NCT01322971|E2|Reported Event|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
160873|NCT01322971|E1|Reported Event|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
160874|NCT01322945|B3|Baseline|Total|Total of all reporting groups
160875|NCT01322945|B2|Baseline|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
160876|NCT01322945|B1|Baseline|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
160972|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
180823|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
160877|NCT01322945|P2|Participant Flow|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
160878|NCT01322945|P1|Participant Flow|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
160879|NCT01322945|O2|Outcome|Control Group|First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
160880|NCT01322945|O1|Outcome|Endonasal Group|First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
160881|NCT01322945|O2|Outcome|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
160882|NCT01322945|O1|Outcome|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
160883|NCT01322945|E2|Reported Event|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
160884|NCT01322945|E1|Reported Event|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
160885|NCT01322841|B3|Baseline|Total|Total of all reporting groups
160886|NCT01322841|B2|Baseline|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
160887|NCT01322841|B1|Baseline|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
160888|NCT01322841|P2|Participant Flow|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
160889|NCT01322841|P1|Participant Flow|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
160890|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
160891|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
160892|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
160893|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
160894|NCT01322841|E2|Reported Event|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
160895|NCT01322841|E1|Reported Event|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
160896|NCT01322815|B3|Baseline|Total|Total of all reporting groups
160897|NCT01322815|B2|Baseline|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
160898|NCT01322815|B1|Baseline|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
160899|NCT01322815|P2|Participant Flow|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
160900|NCT01322815|P1|Participant Flow|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
160901|NCT01322815|O2|Outcome|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
160902|NCT01322815|O1|Outcome|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
160903|NCT01322815|E2|Reported Event|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
160904|NCT01322815|E1|Reported Event|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
160905|NCT01322633|B3|Baseline|Total|Total of all reporting groups
160973|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160906|NCT01322633|B2|Baseline|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160907|NCT01322633|B1|Baseline|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160908|NCT01322633|P2|Participant Flow|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160909|NCT01322633|P1|Participant Flow|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160910|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160911|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160912|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160913|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160914|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160915|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160916|NCT01322633|E2|Reported Event|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
160917|NCT01322633|E1|Reported Event|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
160918|NCT01322607|B3|Baseline|Total|Total of all reporting groups
160919|NCT01322607|B2|Baseline|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160920|NCT01322607|B1|Baseline|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160921|NCT01322607|P2|Participant Flow|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160922|NCT01322607|P1|Participant Flow|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160923|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160924|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160925|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160926|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160927|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160974|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160929|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160930|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160931|NCT01322607|E2|Reported Event|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
160932|NCT01322607|E1|Reported Event|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
160933|NCT01322594|B7|Baseline|Total|Total of all reporting groups
160934|NCT01322594|B6|Baseline|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160935|NCT01322594|B5|Baseline|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160936|NCT01322594|B4|Baseline|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160937|NCT01322594|B3|Baseline|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160938|NCT01322594|B2|Baseline|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160939|NCT01322594|B1|Baseline|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160940|NCT01322594|P6|Participant Flow|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160941|NCT01322594|P5|Participant Flow|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160942|NCT01322594|P4|Participant Flow|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160943|NCT01322594|P3|Participant Flow|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160944|NCT01322594|P2|Participant Flow|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160945|NCT01322594|P1|Participant Flow|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160946|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160947|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160948|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160949|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160950|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160951|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160952|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160953|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160954|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160955|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160956|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160957|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160958|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160959|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160960|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160961|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160962|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160963|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160964|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160965|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160966|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160967|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160968|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160969|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160970|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160971|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160975|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160976|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160977|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160978|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160979|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160980|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160981|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160982|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160983|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160984|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160985|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160986|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160987|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160988|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160989|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160990|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160991|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160992|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160993|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
160994|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160995|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160996|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160997|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160998|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
160999|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
161000|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161001|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161002|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161003|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161004|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161005|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
161006|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161007|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161008|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161009|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161010|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161011|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
161012|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161013|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161014|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161015|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161016|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
161017|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
161018|NCT01322594|E6|Reported Event|MEDI2338 1000 MG|
161019|NCT01322594|E5|Reported Event|MEDI2338 300 MG|
161025|NCT01322386|B2|Baseline|Oral Vancomycin - PSC|Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
161026|NCT01322386|B1|Baseline|Oral Vancomycin-BIliary Atresia|Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
161027|NCT01322386|P2|Participant Flow|Oral Vancomycin/ Primary Sclerosing Cholangitis|Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.
161028|NCT01322386|P1|Participant Flow|Oral Vancomycin-Biliary Atresia|Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
161029|NCT01322386|O5|Outcome|Liver Biopsy and/or MRI|BA-N/A , PSC- 8/9 participants showed improvement of liver biopsies and/or MRI on Vancomycin.
161030|NCT01322386|O4|Outcome|Colon Biopsies|BA - N/A , PSC - 8/8- who had colonoscopies with colon biopsies showed improvement on Vancomycin therapy.
161031|NCT01322386|O3|Outcome|Liver Biopsy|BA - N/A , PSC - 4/4 who had Liver biopsies showed improvement on Vancomycin therapy.
161032|NCT01322386|O2|Outcome|MRI / MRCP|BA-N/A, PSC - 7/7 showed improvement on Vancomycin therapy.
161033|NCT01322386|O1|Outcome|Liver Blood Test|BA -10/10 , PSC - 9/9 - All had improvement on Vancomycin therapy.
161034|NCT01322386|E1|Reported Event|BA/PSC -Oral Vancomycin|Oral Vancomycin is commercially available (Vancocin, ViroPharma Inc.) for treatment of gastrointestinal infection such as, Clostridium difficile infection. In fact, our published observation of using oral vancomycin in treating PSC was an incidental finding to our treatment for Cl. Difficile gastrointestinal infection in a child with PSC (J Pediatr Gastroenterol Nutr 27:580-3, 1998). Since oral vancomycin is poorly absorbed, no serious adverse events were anticipated in this study.
161035|NCT01322360|B1|Baseline|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
161036|NCT01322360|P1|Participant Flow|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
161037|NCT01322360|O1|Outcome|Morphine Sulfate|"oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines~Morphine Sulfate"
161038|NCT01322360|O1|Outcome|Morphine Sulfate|Subjects received morphine sulfate either as oral solution or tablet.
161039|NCT01322360|E1|Reported Event|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
161040|NCT01322347|B3|Baseline|Total|Total of all reporting groups
161041|NCT01322347|B2|Baseline|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161042|NCT01322347|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161043|NCT01322347|P2|Participant Flow|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161044|NCT01322347|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161045|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161046|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161047|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161048|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161049|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161050|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161051|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161052|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161053|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161054|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161055|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161084|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161056|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161057|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161058|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161059|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161060|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161061|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161062|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161063|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161064|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161065|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161066|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161067|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161068|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161069|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161070|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161071|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161072|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161073|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161074|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161075|NCT01322347|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP)|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
161076|NCT01322347|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
161077|NCT01322347|E1|Reported Event|Stage 2 Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
161078|NCT01322022|B3|Baseline|Total|Total of all reporting groups
161079|NCT01322022|B2|Baseline|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161080|NCT01322022|B1|Baseline|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161081|NCT01322022|P2|Participant Flow|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161082|NCT01322022|P1|Participant Flow|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161083|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161085|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161086|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161087|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161088|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161089|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161090|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161091|NCT01322022|E2|Reported Event|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
161092|NCT01322022|E1|Reported Event|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
161093|NCT01322009|B3|Baseline|Total|Total of all reporting groups
161094|NCT01322009|B2|Baseline|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
161095|NCT01322009|B1|Baseline|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
161096|NCT01322009|P2|Participant Flow|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
161097|NCT01322009|P1|Participant Flow|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
161098|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
161099|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
161100|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
161101|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
161102|NCT01322009|E2|Reported Event|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
161148|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
161149|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
161150|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
180824|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
161103|NCT01322009|E1|Reported Event|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
161104|NCT01321749|B3|Baseline|Total|Total of all reporting groups
161105|NCT01321749|B2|Baseline|Stroke Secondary Prevention|Procedure:stroke secondary prevention
161106|NCT01321749|B1|Baseline|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
161107|NCT01321749|P2|Participant Flow|Stroke Secondary Prevention|Procedure:stroke secondary prevention
161108|NCT01321749|P1|Participant Flow|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
161109|NCT01321749|O2|Outcome|Stroke Secondary Prevention|Procedure:stroke secondary prevention
161110|NCT01321749|O1|Outcome|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
161111|NCT01321749|E2|Reported Event|Stroke Secondary Prevention|Procedure:stroke secondary prevention
161112|NCT01321749|E1|Reported Event|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
161113|NCT01321723|B4|Baseline|Total|Total of all reporting groups
161114|NCT01321723|B3|Baseline|Placebo|Placebo : matching tablets, once daily
161115|NCT01321723|B2|Baseline|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161116|NCT01321723|B1|Baseline|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161117|NCT01321723|P3|Participant Flow|Placebo|Placebo : matching tablets, once daily
161118|NCT01321723|P2|Participant Flow|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily.
161119|NCT01321723|P1|Participant Flow|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily.
161120|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
161121|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161122|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161123|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161124|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161125|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
161126|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161127|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161128|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
161129|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161130|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161131|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
161132|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161133|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161134|NCT01321723|E3|Reported Event|Placebo|Placebo : matching tablets, once daily
161135|NCT01321723|E2|Reported Event|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
161136|NCT01321723|E1|Reported Event|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
161137|NCT01321710|B4|Baseline|Total|Total of all reporting groups
161138|NCT01321710|B3|Baseline|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
161139|NCT01321710|B2|Baseline|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
161140|NCT01321710|B1|Baseline|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
161141|NCT01321710|P3|Participant Flow|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
161142|NCT01321710|P2|Participant Flow|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
161143|NCT01321710|P1|Participant Flow|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
161144|NCT01321710|O2|Outcome|Prophylactic Acetaminophen|Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
161145|NCT01321710|O1|Outcome|Standard Immunization Care|Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
161146|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
161147|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
161151|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
161152|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
161153|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
161154|NCT01321710|E3|Reported Event|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
161155|NCT01321710|E2|Reported Event|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
161156|NCT01321710|E1|Reported Event|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
161157|NCT01321697|B1|Baseline|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
161158|NCT01321697|P1|Participant Flow|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
161159|NCT01321697|O1|Outcome|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
161160|NCT01321697|E1|Reported Event|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
161161|NCT01321554|B3|Baseline|Total|Total of all reporting groups
161162|NCT01321554|B2|Baseline|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161163|NCT01321554|B1|Baseline|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161164|NCT01321554|P4|Participant Flow|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20mg on 16 Feb 2013.
161165|NCT01321554|P3|Participant Flow|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
161166|NCT01321554|P2|Participant Flow|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161167|NCT01321554|P1|Participant Flow|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161168|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161169|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161170|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161171|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161172|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161173|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161174|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161175|NCT01321554|E4|Reported Event|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013.
161176|NCT01321554|E3|Reported Event|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
161177|NCT01321554|E2|Reported Event|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161210|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161211|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161178|NCT01321554|E1|Reported Event|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
161179|NCT01321008|B1|Baseline|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
161180|NCT01321008|P1|Participant Flow|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
161181|NCT01321008|O1|Outcome|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
161182|NCT01321008|E1|Reported Event|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
161183|NCT01320826|B1|Baseline|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
161184|NCT01320826|P1|Participant Flow|Patients Undergoing Colonoscopy|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
161185|NCT01320826|O1|Outcome|Percentage of Females ≥ 50 Years With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."
161186|NCT01320826|O1|Outcome|Percentage of Patients Referred to a Specialist.|The percentage of patients who, after having a colonoscopy, are referred to another specialist for their gastrointestinal problem. A specialist was defined as a physician more specialized than the person performing the colonoscopy, and a referral was counted if the physician, at the time of colonoscopy, sent or anticipated sending the patient to a specialist for any reason, or if the patient believed they were being sent to a specialist.
161187|NCT01320826|O1|Outcome|Procedural Time|Procedural time was defined as the time from the first insertion of the colonoscope until it was removed from the anus, in minutes
161188|NCT01320826|O1|Outcome|Patient Satisfaction With Hospital Experience|Patient satisfaction with hospital experience measured on 7 point Likert scale. 7 is extremely satisfied, 1 is extremely dissatisfied.
161189|NCT01320826|O1|Outcome|Patient Wait Time Satisfaction|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"
161190|NCT01320826|O1|Outcome|Patient Comfort During Colonoscopy|Patient discomfort on 5 point scale 0 is no discomfort; 1 is one or two episodes of discomfort, well tolerated; 2 is more than two episodes of discomfort adequately tolerated; 3 is significant discomfort experienced several times during the procedure; 4 is extreme discomfort experienced frequency throughout the procedure.
161191|NCT01320826|O1|Outcome|Withdraw Times, Minutes|
161192|NCT01320826|O1|Outcome|Colonoscopy Complications|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."
161193|NCT01320826|O1|Outcome|Percentage of Males 50 Years and Older Undergoing First Time c|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."
161194|NCT01320826|O1|Outcome|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
161195|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
161196|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
161197|NCT01320826|E1|Reported Event|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
161198|NCT01320735|B1|Baseline|Advanced PCa|Participants with advanced PCa
161199|NCT01320735|P1|Participant Flow|Advanced Prostate Cancer (PCa)|Participants with advanced PCa
161200|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161201|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161202|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161203|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161204|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161205|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161206|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161207|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161208|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161209|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
161214|NCT01320735|E1|Reported Event|Advanced PCa|Participants with advanced PCa
161215|NCT01320683|B1|Baseline|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
161216|NCT01320683|P1|Participant Flow|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
161217|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
161218|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
161219|NCT01320683|E1|Reported Event|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
161220|NCT01320553|B5|Baseline|Total|Total of all reporting groups
161221|NCT01320553|B4|Baseline|Placebo|"Placebo eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
161222|NCT01320553|B3|Baseline|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
161223|NCT01320553|B2|Baseline|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
161224|NCT01320553|B1|Baseline|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
161225|NCT01320553|P4|Participant Flow|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
161226|NCT01320553|P3|Participant Flow|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
161227|NCT01320553|P2|Participant Flow|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
161228|NCT01320553|P1|Participant Flow|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
161229|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
161230|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
161231|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
161232|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
161233|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
161234|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
161235|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
161236|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
161237|NCT01320553|E4|Reported Event|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
161238|NCT01320553|E3|Reported Event|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
161239|NCT01320553|E2|Reported Event|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
161240|NCT01320553|E1|Reported Event|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
161241|NCT01320293|B1|Baseline|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161242|NCT01320293|P1|Participant Flow|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161243|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161244|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161245|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161246|NCT01320293|E1|Reported Event|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
161247|NCT01320202|B3|Baseline|Total|Total of all reporting groups
161248|NCT01320202|B2|Baseline|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months."
161249|NCT01320202|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months."
161250|NCT01320202|P2|Participant Flow|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161251|NCT01320202|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161252|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161253|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161254|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161255|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161256|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161257|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161258|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161259|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161260|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161261|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161262|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161263|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161264|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161265|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161266|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161267|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161268|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161269|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161270|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161271|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161272|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161273|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
161274|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161275|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161276|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161277|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161278|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161279|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161280|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
161281|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
161282|NCT01320202|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
161283|NCT01320202|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
161284|NCT01320202|E1|Reported Event|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
161285|NCT01320137|B3|Baseline|Total|Total of all reporting groups
161286|NCT01320137|B2|Baseline|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161287|NCT01320137|B1|Baseline|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161288|NCT01320137|P2|Participant Flow|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161289|NCT01320137|P1|Participant Flow|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161290|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161291|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161292|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161293|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161294|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161295|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161296|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161297|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161298|NCT01320137|E2|Reported Event|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
161299|NCT01320137|E1|Reported Event|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
161300|NCT01320072|B3|Baseline|Total|Total of all reporting groups
161301|NCT01320072|B2|Baseline|Aspirin-tolerant Asthmatics|aspirin-tolerant patients with asthma
161302|NCT01320072|B1|Baseline|Aspirin-sensitive Asthmatics|patients with aspirin exacerbated respiratory disease
161303|NCT01320072|P2|Participant Flow|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
161304|NCT01320072|P1|Participant Flow|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
161305|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Asthma patients with aspirin exacerbated respiratory disease
161306|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
161307|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
161308|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
161309|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
161310|NCT01320072|E2|Reported Event|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
161311|NCT01320072|E1|Reported Event|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
161312|NCT01319877|B3|Baseline|Total|Total of all reporting groups
161313|NCT01319877|B2|Baseline|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161314|NCT01319877|B1|Baseline|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161315|NCT01319877|P2|Participant Flow|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161316|NCT01319877|P1|Participant Flow|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161317|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161318|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161319|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161320|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161321|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161322|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161323|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161324|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161325|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161326|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161327|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161328|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161329|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161330|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161331|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161332|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161333|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161334|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161335|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161336|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161337|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161338|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
180825|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
161339|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161340|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161341|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161342|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161343|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161344|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161345|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161346|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161347|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
161348|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
161349|NCT01319877|E1|Reported Event|First and Second Line Treatment|The participants from the first line and second line treatments were combined for the adverse event analysis.
161350|NCT01319851|B1|Baseline|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161351|NCT01319851|P1|Participant Flow|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161352|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161353|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161354|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161355|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161356|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161357|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161358|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161359|NCT01319851|E1|Reported Event|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
161360|NCT01319773|B6|Baseline|Total|Total of all reporting groups
161361|NCT01319773|B5|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
161362|NCT01319773|B4|Baseline|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
161363|NCT01319773|B3|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
161364|NCT01319773|B2|Baseline|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
161365|NCT01319773|B1|Baseline|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
161366|NCT01319773|P5|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
161367|NCT01319773|P4|Participant Flow|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
161368|NCT01319773|P3|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
161369|NCT01319773|P2|Participant Flow|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
161370|NCT01319773|P1|Participant Flow|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
161371|NCT01319773|O3|Outcome|Cyclosporine 0.05%|
161372|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
161373|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
161374|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
161375|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
161376|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
161377|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
161497|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161378|NCT01319773|E5|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
161379|NCT01319773|E4|Reported Event|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
161380|NCT01319773|E3|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
161381|NCT01319773|E2|Reported Event|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
161382|NCT01319773|E1|Reported Event|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
161383|NCT01319721|B3|Baseline|Total|Total of all reporting groups
161384|NCT01319721|B2|Baseline|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161385|NCT01319721|B1|Baseline|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161386|NCT01319721|P2|Participant Flow|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161387|NCT01319721|P1|Participant Flow|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161388|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161389|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161390|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161391|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161392|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161393|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161394|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161395|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161396|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161397|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161398|NCT01319721|E2|Reported Event|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
161399|NCT01319721|E1|Reported Event|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
161400|NCT01319617|B1|Baseline|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
161401|NCT01319617|P1|Participant Flow|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center."
161402|NCT01319617|O1|Outcome|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
161403|NCT01319617|E1|Reported Event|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
161404|NCT01319552|B1|Baseline|Transfusion|"Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions~1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions"
161405|NCT01319552|P1|Participant Flow|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
161406|NCT01319552|O2|Outcome|Old Transfusion|Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
161407|NCT01319552|O1|Outcome|Fresh Transfusion|Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
161408|NCT01319552|E1|Reported Event|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
161409|NCT01319500|B3|Baseline|Total|Total of all reporting groups
161410|NCT01319500|B2|Baseline|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161411|NCT01319500|B1|Baseline|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161412|NCT01319500|P2|Participant Flow|Other OCs|"Users of oral contraceptives (OCs) except Yasmin (Other OCs)"
161413|NCT01319500|P1|Participant Flow|Yasmin|"Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin"
161414|NCT01319500|O5|Outcome|Total|All gynecologists (private and public) and dermatologists
161415|NCT01319500|O4|Outcome|Dermatologists|All dermatologists
161416|NCT01319500|O3|Outcome|Gynecologists (Public Practice Only)|Gynecologists in public practice only
161417|NCT01319500|O2|Outcome|Gynecologists (Private Practice Only)|Gynecologists in private practice only
161418|NCT01319500|O1|Outcome|Gynecologists (All)|All gynecologists (private and public)
161419|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161420|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161421|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161422|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161423|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161424|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161425|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161426|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161427|NCT01319500|E2|Reported Event|Other OCs|"Users of OCs except Yasmin (Other OCs)"
161428|NCT01319500|E1|Reported Event|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
161429|NCT01319422|B3|Baseline|Total|Total of all reporting groups
161430|NCT01319422|B2|Baseline|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161431|NCT01319422|B1|Baseline|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161432|NCT01319422|P2|Participant Flow|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161433|NCT01319422|P1|Participant Flow|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161434|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161435|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161436|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161437|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161438|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161439|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161440|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161441|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161442|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161443|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161444|NCT01319422|E2|Reported Event|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161445|NCT01319422|E1|Reported Event|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
161446|NCT01319396|B1|Baseline|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
161447|NCT01319396|P1|Participant Flow|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
161448|NCT01319396|O1|Outcome|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
162026|NCT01317667|P3|Participant Flow|Group 3|RVEc vaccine 100 μg/dose x 1 dose
161449|NCT01319396|E1|Reported Event|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
161450|NCT01319318|B1|Baseline|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
161451|NCT01319318|P1|Participant Flow|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
161452|NCT01319318|O1|Outcome|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
161453|NCT01319318|E1|Reported Event|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
161454|NCT01319045|B1|Baseline|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161455|NCT01319045|P1|Participant Flow|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161456|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161457|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161458|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161459|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161460|NCT01319045|E1|Reported Event|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
161461|NCT01318967|B1|Baseline|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
161462|NCT01318967|P1|Participant Flow|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
161463|NCT01318967|O1|Outcome|MRI After Furosemide|"After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow~Furosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only."
161464|NCT01318967|O1|Outcome|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.~Renal blood flow is measured by PAH method and by MRI method"
161465|NCT01318967|E1|Reported Event|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
161466|NCT01318876|B1|Baseline|Health Care Workers|HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
161467|NCT01318876|P1|Participant Flow|Health Care Workers|
161468|NCT01318876|O1|Outcome|HCW From All Sites|
161469|NCT01318876|O1|Outcome|HCW From All Sites|
161470|NCT01318876|E1|Reported Event|HCW From All Sites|
161471|NCT01318733|B1|Baseline|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
161472|NCT01318733|P1|Participant Flow|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
161473|NCT01318733|O1|Outcome|CD07805/47 Gel 0.5% QD|
161474|NCT01318733|E1|Reported Event|CD07805/47 Gel 0.5%|
161475|NCT01318694|B5|Baseline|Total|Total of all reporting groups
161476|NCT01318694|B4|Baseline|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161477|NCT01318694|B3|Baseline|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161478|NCT01318694|B2|Baseline|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161479|NCT01318694|B1|Baseline|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161480|NCT01318694|P4|Participant Flow|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161481|NCT01318694|P3|Participant Flow|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
161482|NCT01318694|P2|Participant Flow|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
161483|NCT01318694|P1|Participant Flow|Treatment Arm A|Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
161484|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161485|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161486|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161487|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161488|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161489|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161490|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161491|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161492|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161493|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161494|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161495|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161496|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161498|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161499|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161500|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161501|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161502|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161503|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161504|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161505|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161506|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161507|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161508|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161509|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161510|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161511|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161512|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161513|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161514|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161515|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161516|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161517|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161518|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161519|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161520|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161521|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161522|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161523|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161524|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161525|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161526|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161527|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161528|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161529|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161530|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
161531|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161532|NCT01318694|E4|Reported Event|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
161533|NCT01318694|E3|Reported Event|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
161534|NCT01318694|E2|Reported Event|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
161535|NCT01318694|E1|Reported Event|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
161536|NCT01318512|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
161537|NCT01318512|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
161538|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161539|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161540|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161541|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161542|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
162245|NCT01316575|E1|Reported Event|nCPAP|
161543|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161544|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161545|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161546|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161547|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
161548|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161549|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.
161550|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161551|NCT01318512|E1|Reported Event|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
161552|NCT01318499|B4|Baseline|Total|Total of all reporting groups
161553|NCT01318499|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161554|NCT01318499|B2|Baseline|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161555|NCT01318499|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161556|NCT01318499|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161557|NCT01318499|P2|Participant Flow|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161558|NCT01318499|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161559|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161560|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161561|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161562|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161563|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161564|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161565|NCT01318499|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161566|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161567|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161568|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161569|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161570|NCT01318499|O2|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161571|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161572|NCT01318499|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161573|NCT01318499|E2|Reported Event|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161574|NCT01318499|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
161575|NCT01318408|B1|Baseline|Open Label|All participants received study drug.
161576|NCT01318408|P1|Participant Flow|Open Label|All participants received study drug.
161577|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
161578|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
161579|NCT01318408|E1|Reported Event|Open Label|All participants received study drug. Four withdrew due to adverse events; related to fatigue.
161580|NCT01318382|B1|Baseline|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
161581|NCT01318382|P1|Participant Flow|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
161582|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
161583|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
161584|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
161585|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
161586|NCT01318382|E1|Reported Event|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
161587|NCT01318278|B4|Baseline|Total|Total of all reporting groups
161588|NCT01318278|B3|Baseline|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161589|NCT01318278|B2|Baseline|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161590|NCT01318278|B1|Baseline|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161591|NCT01318278|P3|Participant Flow|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161592|NCT01318278|P2|Participant Flow|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161593|NCT01318278|P1|Participant Flow|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161594|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161595|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161647|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161596|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161597|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161598|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161599|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161600|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161601|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161602|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161603|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161604|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161605|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161606|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161607|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161608|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161609|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161610|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161611|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161612|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161613|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161614|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161615|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161616|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161617|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161618|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161619|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161620|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161621|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161622|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161965|NCT01317797|B4|Baseline|Total|Total of all reporting groups
161623|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161624|NCT01318278|O3|Outcome|Comparison Group|Infants not diagnosed with hypotension in first 24 hours
161625|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161626|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161627|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161628|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161629|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161630|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161631|NCT01318278|E3|Reported Event|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
161632|NCT01318278|E2|Reported Event|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
161633|NCT01318278|E1|Reported Event|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
161634|NCT01318135|B5|Baseline|Total|Total of all reporting groups
161635|NCT01318135|B4|Baseline|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161636|NCT01318135|B3|Baseline|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161637|NCT01318135|B2|Baseline|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161638|NCT01318135|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161639|NCT01318135|P8|Participant Flow|Metformin Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
161640|NCT01318135|P7|Participant Flow|Metformin Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
161641|NCT01318135|P6|Participant Flow|CCT/006 - 25 mg Dose Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
161642|NCT01318135|P5|Participant Flow|CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
161643|NCT01318135|P4|Participant Flow|Glimepiride Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
161644|NCT01318135|P3|Participant Flow|Glimepiride Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
161645|NCT01318135|P2|Participant Flow|CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
161646|NCT01318135|P1|Participant Flow|CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
161648|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161649|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161650|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161651|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161652|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161653|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161654|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161655|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161656|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161657|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161658|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161659|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161660|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161661|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161662|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161663|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161664|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161665|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161666|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161667|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161668|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161669|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161670|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161671|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161672|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161673|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161674|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161675|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161676|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161677|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161678|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161679|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161680|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161681|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161682|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161683|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161684|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161685|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161686|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161687|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161688|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161689|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161690|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161691|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161692|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161693|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161694|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161695|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161696|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161697|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161698|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161699|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161700|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161701|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161702|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161703|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161704|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161705|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
180826|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
161706|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161707|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161708|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161709|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161710|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161711|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161712|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161713|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161714|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161715|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161716|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161717|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161718|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161719|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161720|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161721|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161722|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161723|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161724|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161725|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161726|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161727|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161728|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161729|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161730|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161731|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161732|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161733|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161734|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
180827|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
161735|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161736|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161737|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161738|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161739|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161740|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161741|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161742|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161743|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161744|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161745|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161746|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161747|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161748|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161749|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161750|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161751|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161752|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161753|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161754|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161755|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161756|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161757|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161758|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161759|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161760|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161761|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161762|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161763|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161764|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161765|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161766|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161767|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161768|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161769|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161770|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161771|NCT01318135|E4|Reported Event|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161772|NCT01318135|E3|Reported Event|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
161773|NCT01318135|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161774|NCT01318135|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
161775|NCT01318122|B3|Baseline|Total|Total of all reporting groups
161776|NCT01318122|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161777|NCT01318122|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161778|NCT01318122|P4|Participant Flow|Pioglitazone Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
161779|NCT01318122|P3|Participant Flow|Pioglitazone Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
161780|NCT01318122|P2|Participant Flow|CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
161781|NCT01318122|P1|Participant Flow|CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
161782|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161783|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161784|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161785|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161786|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161787|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161788|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161789|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161790|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161791|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161792|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161793|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161794|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161795|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161796|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161797|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161798|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161799|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161800|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161801|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161802|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161803|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161804|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161805|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161806|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161807|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161808|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161809|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161810|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161811|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161812|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161813|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161814|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161815|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161816|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161817|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161818|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161819|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161820|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161821|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161822|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161823|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161824|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161825|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161826|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161827|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161828|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161829|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161830|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161831|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161832|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161833|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161834|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161835|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161836|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161837|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161838|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161839|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161840|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161841|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161842|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161843|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161844|NCT01318122|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
161845|NCT01318122|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
161846|NCT01318109|B4|Baseline|Total|Total of all reporting groups
161847|NCT01318109|B3|Baseline|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161848|NCT01318109|B2|Baseline|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161849|NCT01318109|B1|Baseline|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161850|NCT01318109|P3|Participant Flow|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161851|NCT01318109|P2|Participant Flow|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161852|NCT01318109|P1|Participant Flow|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161853|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161854|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161855|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161856|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161857|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161858|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161859|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161860|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161966|NCT01317797|B3|Baseline|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161861|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161862|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161863|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161864|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161865|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161866|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161867|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161868|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161869|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161870|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161871|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161872|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161873|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161874|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161875|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161876|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161877|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161878|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161879|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161880|NCT01318109|E3|Reported Event|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161881|NCT01318109|E2|Reported Event|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161882|NCT01318109|E1|Reported Event|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
161883|NCT01318083|B4|Baseline|Total|Total of all reporting groups
161884|NCT01318083|B3|Baseline|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161885|NCT01318083|B2|Baseline|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161886|NCT01318083|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161887|NCT01318083|P3|Participant Flow|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161888|NCT01318083|P2|Participant Flow|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161889|NCT01318083|P1|Participant Flow|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161890|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161891|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161892|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161893|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161967|NCT01317797|B2|Baseline|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161894|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161895|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161896|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161897|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161898|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161899|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161900|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161901|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161902|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161903|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161904|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161905|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161906|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161907|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161908|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161909|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161910|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161911|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161912|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161913|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161914|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161915|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161916|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161917|NCT01318083|E3|Reported Event|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
161918|NCT01318083|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161919|NCT01318083|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
161920|NCT01318070|B4|Baseline|Total|Total of all reporting groups
161921|NCT01318070|B3|Baseline|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161922|NCT01318070|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161923|NCT01318070|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161924|NCT01318070|P3|Participant Flow|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161925|NCT01318070|P2|Participant Flow|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161926|NCT01318070|P1|Participant Flow|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161927|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161928|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161929|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161930|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161931|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161932|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161933|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161934|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161935|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161936|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161937|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161938|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161939|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161940|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161941|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161942|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161943|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161944|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161945|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161946|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161947|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161948|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161949|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161950|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161951|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161952|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161953|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161954|NCT01318070|E3|Reported Event|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161955|NCT01318070|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161956|NCT01318070|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
161957|NCT01317901|B3|Baseline|Total|Total of all reporting groups
161958|NCT01317901|B2|Baseline|TRU-016 (20 mg/kg) +Bendamustine+Rituximab|
161959|NCT01317901|B1|Baseline|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|
161960|NCT01317901|P1|Participant Flow|TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
161961|NCT01317901|O2|Outcome|20 mg/kg of TRU 016 Combined With Rituximab 375 mg/m2 and Bend|20 mg/kg of TRU 016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
161962|NCT01317901|O1|Outcome|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|"10 mg/kg of TRU 016 combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.~TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle~Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.~Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle."
161963|NCT01317901|E2|Reported Event|TRU-016 (20 mg/kg)|TRU-016 (20 mg/kg) + bendamustine + rituximab
161964|NCT01317901|E1|Reported Event|TRU-016 (10 mg/kg)|TRU-016 (10 mg/kg) + bendamustine + rituximab
161968|NCT01317797|B1|Baseline|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161969|NCT01317797|P3|Participant Flow|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161970|NCT01317797|P2|Participant Flow|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161971|NCT01317797|P1|Participant Flow|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161972|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161973|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161974|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161975|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161976|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161977|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161978|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161979|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161980|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161981|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161982|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161983|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161984|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
161985|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161986|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161987|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161988|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161989|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161990|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161991|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161992|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161993|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161994|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161995|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161996|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161997|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
161998|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
161999|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162000|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162001|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162002|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162003|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162004|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162005|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162006|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162007|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162008|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162009|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162010|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162011|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162012|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162013|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162014|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162015|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162016|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162017|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162018|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162019|NCT01317797|E3|Reported Event|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
162020|NCT01317797|E2|Reported Event|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
162021|NCT01317797|E1|Reported Event|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
162027|NCT01317667|P2|Participant Flow|Group 2|RVEc vaccine 50 μg/dose x 3 doses
162028|NCT01317667|P1|Participant Flow|Group 1|RVEc vaccine 20 μg/dose x 3 doses
162029|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
162030|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
162031|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
162032|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
162033|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
162034|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
162035|NCT01317667|E3|Reported Event|Group 3|RVEc vaccine 100 μg/dose x 1 dose
162036|NCT01317667|E2|Reported Event|Group 2|RVEc vaccine 50 μg/dose x 3 doses
162037|NCT01317667|E1|Reported Event|Group 1|RVEc vaccine 20 μg/dose x 3 doses
162038|NCT01317615|B1|Baseline|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162039|NCT01317615|P1|Participant Flow|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162040|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162041|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162042|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162043|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162044|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162045|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162046|NCT01317615|E1|Reported Event|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
162047|NCT01317160|B3|Baseline|Total|Total of all reporting groups
162048|NCT01317160|B2|Baseline|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
162049|NCT01317160|B1|Baseline|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
162050|NCT01317160|P2|Participant Flow|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
162051|NCT01317160|P1|Participant Flow|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
162052|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
162053|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
162054|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
162055|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
162056|NCT01317160|E2|Reported Event|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
180828|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
162057|NCT01317160|E1|Reported Event|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
162058|NCT01317004|B3|Baseline|Total|Total of all reporting groups
162059|NCT01317004|B2|Baseline|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162060|NCT01317004|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162061|NCT01317004|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162062|NCT01317004|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162063|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162064|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162065|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162066|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162067|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162068|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162069|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162070|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162071|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162072|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162073|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162074|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162075|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162076|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162077|NCT01317004|E2|Reported Event|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
162078|NCT01317004|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
162079|NCT01316926|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2
162080|NCT01316926|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
162081|NCT01316926|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
162082|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
162083|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
162084|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
162085|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
162086|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
162087|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
162088|NCT01316926|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
162089|NCT01316926|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
162090|NCT01316913|B5|Baseline|Total|Total of all reporting groups
162401|NCT01316302|P2|Participant Flow|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
162091|NCT01316913|B4|Baseline|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162092|NCT01316913|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162093|NCT01316913|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162094|NCT01316913|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162095|NCT01316913|P4|Participant Flow|TIO18 µg QD|Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162096|NCT01316913|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162097|NCT01316913|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162098|NCT01316913|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
162099|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162100|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162101|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162102|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162103|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162104|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162105|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162106|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162107|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162108|NCT01316913|O3|Outcome|UMEC/VI 125/25 QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162109|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162110|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162111|NCT01316913|E4|Reported Event|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
162112|NCT01316913|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162113|NCT01316913|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162114|NCT01316913|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
162115|NCT01316900|B5|Baseline|Total|Total of all reporting groups
162116|NCT01316900|B4|Baseline|Tiotropium 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162117|NCT01316900|B3|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162118|NCT01316900|B2|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162119|NCT01316900|B1|Baseline|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162120|NCT01316900|P4|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162121|NCT01316900|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162122|NCT01316900|P2|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162123|NCT01316900|P1|Participant Flow|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162124|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162125|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162126|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162127|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162128|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162129|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162130|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162402|NCT01316302|P1|Participant Flow|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
162131|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162132|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162133|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162134|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162135|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162136|NCT01316900|E4|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
162137|NCT01316900|E3|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162138|NCT01316900|E2|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
162139|NCT01316900|E1|Reported Event|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
162140|NCT01316887|B4|Baseline|Total|Total of all reporting groups
162141|NCT01316887|B3|Baseline|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162142|NCT01316887|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162143|NCT01316887|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162144|NCT01316887|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162145|NCT01316887|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162146|NCT01316887|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162147|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162148|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162149|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162150|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162151|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162152|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162153|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162154|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162155|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162156|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162157|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162158|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162159|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162160|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162161|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162162|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162163|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162164|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162165|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162166|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162167|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162168|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162169|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162170|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162171|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162172|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162173|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162174|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162175|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162176|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162177|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162178|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162179|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162180|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162181|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162182|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162183|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162184|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162185|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162186|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162187|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162188|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162189|NCT01316887|O3|Outcome|UMEC/VI 125/25µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162190|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162191|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162192|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162193|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162194|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162195|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162196|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162197|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162198|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162199|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162200|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162201|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162202|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162203|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
162204|NCT01316887|E3|Reported Event|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
162205|NCT01316887|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
162206|NCT01316887|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
162207|NCT01316692|B1|Baseline|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162208|NCT01316692|P1|Participant Flow|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162209|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162403|NCT01316302|O2|Outcome|Placebo|Matching placebo
162404|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
162210|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162211|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162212|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162213|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162214|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162215|NCT01316692|E1|Reported Event|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
162216|NCT01316614|B1|Baseline|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
162217|NCT01316614|P1|Participant Flow|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
162218|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162219|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162220|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162221|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162222|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162223|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162224|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162225|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162226|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162227|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162228|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
162229|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
162230|NCT01316614|E1|Reported Event|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
162231|NCT01316575|B3|Baseline|Total|Total of all reporting groups
162232|NCT01316575|B2|Baseline|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162233|NCT01316575|B1|Baseline|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162234|NCT01316575|P2|Participant Flow|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162235|NCT01316575|P1|Participant Flow|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162236|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162237|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162238|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162239|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162240|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162241|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162242|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
162243|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
162244|NCT01316575|E2|Reported Event|Low Flow Oxygen|
162246|NCT01316419|B1|Baseline|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162247|NCT01316419|P1|Participant Flow|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162248|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162249|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162250|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162251|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162252|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162253|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162254|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162255|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162256|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162257|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162258|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162259|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162260|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162261|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162262|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162263|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162264|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162265|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162405|NCT01316302|O2|Outcome|Placebo|Matching placebo
162406|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
162266|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162267|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162268|NCT01316419|E1|Reported Event|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
162269|NCT01316380|B4|Baseline|Total|Total of all reporting groups
162270|NCT01316380|B3|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162271|NCT01316380|B2|Baseline|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162272|NCT01316380|B1|Baseline|Placebo|Patients treated with matching placebo
162273|NCT01316380|P3|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162274|NCT01316380|P2|Participant Flow|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162275|NCT01316380|P1|Participant Flow|Placebo|Patients treated with matching placebo
162276|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162277|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162278|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162279|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162280|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162281|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162282|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162283|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162284|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162285|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162286|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162287|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162288|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162289|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162290|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162291|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162292|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162293|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162294|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162295|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162296|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162297|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162298|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162299|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162300|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162301|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162302|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162303|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162304|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162305|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162306|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
162307|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
162308|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
162309|NCT01316380|E3|Reported Event|Tio R5|Enter description here, if needed
162310|NCT01316380|E2|Reported Event|Tio R2.5|Enter description here, if needed
162311|NCT01316380|E1|Reported Event|Placebo|Enter description here, if needed
162312|NCT01316341|B4|Baseline|Total|Total of all reporting groups
162313|NCT01316341|B3|Baseline|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
162314|NCT01316341|B2|Baseline|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
162315|NCT01316341|B1|Baseline|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
162316|NCT01316341|P3|Participant Flow|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
162351|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162317|NCT01316341|P2|Participant Flow|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
162318|NCT01316341|P1|Participant Flow|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
162319|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162320|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162321|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
162322|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162323|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162324|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
162325|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
162326|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
162327|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
162328|NCT01316341|O2|Outcome|Empa 25 mg|A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
162329|NCT01316341|O1|Outcome|Empa 10 mg|A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
162330|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162331|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162332|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162333|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162334|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162335|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162336|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162337|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162338|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162339|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162340|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162341|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162342|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162343|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162344|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162345|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162346|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162347|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162348|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162349|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162350|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162352|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162353|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162354|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
162355|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
162356|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162357|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162358|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162359|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162360|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162361|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162362|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162363|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162364|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162365|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162366|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162367|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162368|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162369|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162370|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162371|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162372|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162373|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162374|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162375|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162376|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162377|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162378|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
162379|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
162380|NCT01316341|E3|Reported Event|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
162381|NCT01316341|E2|Reported Event|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
162382|NCT01316341|E1|Reported Event|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
162383|NCT01316315|B3|Baseline|Total|Total of all reporting groups
162384|NCT01316315|B2|Baseline|Placebo|Non-Active
162385|NCT01316315|B1|Baseline|Active|N6022 - 5 mg
162386|NCT01316315|P2|Participant Flow|Placebo|Non-Active
162387|NCT01316315|P1|Participant Flow|Active|N6022 - Active 5 mg
162388|NCT01316315|O2|Outcome|Placebo|Non-Active
162389|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
162390|NCT01316315|O2|Outcome|Placebo|Non-Active
162391|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
162392|NCT01316315|O2|Outcome|Placebo|Non-Active
162393|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
162394|NCT01316315|O2|Outcome|Placebo|Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
162395|NCT01316315|O1|Outcome|N6022|Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.
162396|NCT01316315|E2|Reported Event|Placebo|Non-Active
162397|NCT01316315|E1|Reported Event|Active|N6022 - Active 5 mg
162398|NCT01316302|B3|Baseline|Total|Total of all reporting groups
162399|NCT01316302|B2|Baseline|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
162400|NCT01316302|B1|Baseline|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
162407|NCT01316302|O2|Outcome|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
162408|NCT01316302|O1|Outcome|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
162409|NCT01316302|E2|Reported Event|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
162410|NCT01316302|E1|Reported Event|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
162411|NCT01316263|B3|Baseline|Total|Total of all reporting groups
162412|NCT01316263|B2|Baseline|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162413|NCT01316263|B1|Baseline|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162414|NCT01316263|P2|Participant Flow|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162415|NCT01316263|P1|Participant Flow|PDGFRα Mutation Positive|20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
162416|NCT01316263|O1|Outcome|PDGFRα Mutation Positive and Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation and that did not have a PDGFRα mutation.
162417|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162418|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162419|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162420|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162421|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162422|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162423|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162424|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162425|NCT01316263|O1|Outcome|Olaratumab (IMC-3G3)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation or PDGFRα wild type.
162426|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162427|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162428|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162429|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162430|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162431|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162432|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162433|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162434|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162435|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162436|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162437|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162438|NCT01316263|E2|Reported Event|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
162477|NCT01316042|P1|Participant Flow|Sugar Pill|2 pills per day for 12 months
162439|NCT01316263|E1|Reported Event|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
162440|NCT01316224|B1|Baseline|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162441|NCT01316224|P1|Participant Flow|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162442|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162443|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162444|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162445|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162446|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162447|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162448|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162449|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162450|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162451|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162452|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
162453|NCT01316224|E1|Reported Event|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with Adalimumab
162454|NCT01316055|B4|Baseline|Total|Total of all reporting groups
162455|NCT01316055|B3|Baseline|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162456|NCT01316055|B2|Baseline|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162457|NCT01316055|B1|Baseline|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162458|NCT01316055|P3|Participant Flow|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162459|NCT01316055|P2|Participant Flow|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162460|NCT01316055|P1|Participant Flow|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162461|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162462|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162463|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162464|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162465|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162466|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162467|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162468|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162469|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162470|NCT01316055|E3|Reported Event|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162471|NCT01316055|E2|Reported Event|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162472|NCT01316055|E1|Reported Event|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
162473|NCT01316042|B3|Baseline|Total|Total of all reporting groups
162474|NCT01316042|B2|Baseline|Metformin|2 212.5mg pill/day for 12 months
162475|NCT01316042|B1|Baseline|Sugar Pill|2 pills per day for 12 months
162476|NCT01316042|P2|Participant Flow|Metformin|2 212.5mg pill/day for 12 months
162480|NCT01316042|E2|Reported Event|Metformin|2 212.5mg pill/day for 12 months
162481|NCT01316042|E1|Reported Event|Sugar Pill|2 pills per day for 12 months
162482|NCT01315847|B3|Baseline|Total|Total of all reporting groups
162483|NCT01315847|B2|Baseline|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162484|NCT01315847|B1|Baseline|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162485|NCT01315847|P2|Participant Flow|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162486|NCT01315847|P1|Participant Flow|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162487|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162488|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162489|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162490|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162491|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
180829|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
162492|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162493|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162494|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162495|NCT01315847|E2|Reported Event|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162496|NCT01315847|E1|Reported Event|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
162497|NCT01315665|B3|Baseline|Total|Total of all reporting groups
162498|NCT01315665|B2|Baseline|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162499|NCT01315665|B1|Baseline|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162500|NCT01315665|P2|Participant Flow|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162501|NCT01315665|P1|Participant Flow|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162502|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162503|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162504|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162505|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162506|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162507|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162508|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162509|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162510|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162511|NCT01315665|O1|Outcome|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162512|NCT01315665|E2|Reported Event|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162513|NCT01315665|E1|Reported Event|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
162514|NCT01315574|B3|Baseline|Total|Total of all reporting groups
162515|NCT01315574|B2|Baseline|Travoprost (Travatan Z)|"20 Patients will be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162516|NCT01315574|B1|Baseline|Latanoprost (Xalatan)|"20 Patients will be randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162517|NCT01315574|P2|Participant Flow|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162518|NCT01315574|P1|Participant Flow|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162519|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162520|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162521|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162522|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162523|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"20 Patients will be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162524|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"20 Patients will be randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162525|NCT01315574|E2|Reported Event|Travoprost (Travatan Z)|"7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
162526|NCT01315574|E1|Reported Event|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
162527|NCT01315249|B3|Baseline|Total|Total of all reporting groups
162528|NCT01315249|B2|Baseline|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162529|NCT01315249|B1|Baseline|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162530|NCT01315249|P2|Participant Flow|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162531|NCT01315249|P1|Participant Flow|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162532|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162533|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162534|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162535|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162536|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162537|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162538|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162539|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162540|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162541|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162542|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162543|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162544|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162545|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162546|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162547|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162548|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162549|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162550|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162551|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162552|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162553|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162554|NCT01315249|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
162555|NCT01315249|E1|Reported Event|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
162556|NCT01315158|B3|Baseline|Total|Total of all reporting groups
162557|NCT01315158|B2|Baseline|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162558|NCT01315158|B1|Baseline|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162559|NCT01315158|P2|Participant Flow|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162560|NCT01315158|P1|Participant Flow|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162561|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162562|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162563|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162564|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162565|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162566|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162567|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162568|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
163277|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
162569|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162570|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162571|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162572|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162573|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162574|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162575|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162576|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162577|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162578|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162579|NCT01315158|E2|Reported Event|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
162580|NCT01315158|E1|Reported Event|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
162581|NCT01315145|B3|Baseline|Total|Total of all reporting groups
162582|NCT01315145|B2|Baseline|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
162583|NCT01315145|B1|Baseline|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
162584|NCT01315145|P2|Participant Flow|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
162585|NCT01315145|P1|Participant Flow|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
162586|NCT01315145|O2|Outcome|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
162587|NCT01315145|O1|Outcome|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
162588|NCT01315145|E2|Reported Event|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
162589|NCT01315145|E1|Reported Event|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
162590|NCT01315028|B3|Baseline|Total|Total of all reporting groups
162591|NCT01315028|B2|Baseline|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162592|NCT01315028|B1|Baseline|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162593|NCT01315028|P2|Participant Flow|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162594|NCT01315028|P1|Participant Flow|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162595|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162596|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162597|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162598|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162599|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162600|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162601|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162602|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162603|NCT01315028|E2|Reported Event|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
162604|NCT01315028|E1|Reported Event|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
162605|NCT01315002|B1|Baseline|All Study Participants|Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
162606|NCT01315002|P2|Participant Flow|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
180830|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
162607|NCT01315002|P1|Participant Flow|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
162608|NCT01315002|O2|Outcome|Placebo Patch|"Placebo patch~Placebo patch: Placebo patch"
162609|NCT01315002|O1|Outcome|Nicotine Patch|"Transdermal nicotine patch~Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)"
162610|NCT01315002|E2|Reported Event|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
162611|NCT01315002|E1|Reported Event|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
162612|NCT01314872|B12|Baseline|Total|Total of all reporting groups
162613|NCT01314872|B11|Baseline|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
162614|NCT01314872|B10|Baseline|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
162615|NCT01314872|B9|Baseline|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162616|NCT01314872|B8|Baseline|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162617|NCT01314872|B7|Baseline|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162618|NCT01314872|B6|Baseline|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162619|NCT01314872|B5|Baseline|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162620|NCT01314872|B4|Baseline|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162621|NCT01314872|B3|Baseline|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162622|NCT01314872|B2|Baseline|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162623|NCT01314872|B1|Baseline|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162624|NCT01314872|P15|Participant Flow|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162625|NCT01314872|P14|Participant Flow|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162626|NCT01314872|P13|Participant Flow|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162627|NCT01314872|P12|Participant Flow|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162628|NCT01314872|P11|Participant Flow|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
162629|NCT01314872|P10|Participant Flow|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
162630|NCT01314872|P9|Participant Flow|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162631|NCT01314872|P8|Participant Flow|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162632|NCT01314872|P7|Participant Flow|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
163175|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
162633|NCT01314872|P6|Participant Flow|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162634|NCT01314872|P5|Participant Flow|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162635|NCT01314872|P4|Participant Flow|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162636|NCT01314872|P3|Participant Flow|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162637|NCT01314872|P2|Participant Flow|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162638|NCT01314872|P1|Participant Flow|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162639|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162640|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162641|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162642|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162643|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162644|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162645|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162646|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162647|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162648|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162649|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162673|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162696|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
162650|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162651|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162652|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162653|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162654|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162655|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162656|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162657|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162658|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162659|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162660|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162661|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162662|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162663|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162664|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162665|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162666|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162667|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162668|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162669|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162670|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162671|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162672|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
163176|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
162674|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162675|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162676|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162677|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162678|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162679|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162680|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162681|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162682|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162683|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162684|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
162685|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
162686|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162687|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162688|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162689|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162690|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162691|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162692|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162693|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162694|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162695|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
162697|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162698|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162699|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162700|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162701|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162702|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162703|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162704|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162705|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162706|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
162707|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162708|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162709|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162710|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162711|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162712|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162713|NCT01314872|E15|Reported Event|Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
162714|NCT01314872|E14|Reported Event|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
162715|NCT01314872|E13|Reported Event|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162716|NCT01314872|E12|Reported Event|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
162717|NCT01314872|E11|Reported Event|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
162718|NCT01314872|E10|Reported Event|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
162719|NCT01314872|E9|Reported Event|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162720|NCT01314872|E8|Reported Event|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
162721|NCT01314872|E7|Reported Event|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
163177|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
162722|NCT01314872|E6|Reported Event|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
162723|NCT01314872|E5|Reported Event|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162724|NCT01314872|E4|Reported Event|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162725|NCT01314872|E3|Reported Event|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162726|NCT01314872|E2|Reported Event|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
162727|NCT01314872|E1|Reported Event|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
162728|NCT01314742|B3|Baseline|Total|Total of all reporting groups
162729|NCT01314742|B2|Baseline|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
162730|NCT01314742|B1|Baseline|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
162731|NCT01314742|P2|Participant Flow|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
162732|NCT01314742|P1|Participant Flow|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
162733|NCT01314742|O2|Outcome|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
162734|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
162735|NCT01314742|O2|Outcome|Sterile Water Group|Study group receiving timed oral care with Sterile Water
162736|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|Study group receiving timed oral care with Biotene OralBalance® gel Arm
162737|NCT01314742|E2|Reported Event|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
162738|NCT01314742|E1|Reported Event|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
162739|NCT01314716|B3|Baseline|Total|Total of all reporting groups
162740|NCT01314716|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162741|NCT01314716|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162742|NCT01314716|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
162743|NCT01314716|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
162744|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162745|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162746|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162747|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162748|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162749|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162750|NCT01314716|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162751|NCT01314716|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162752|NCT01314716|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162753|NCT01314716|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
162754|NCT01314703|B1|Baseline|Group 1|All subjects received treatment with both the test article and the positive control
162755|NCT01314703|P1|Participant Flow|ChloraPrep and 70% Isopropyl Alcohol|All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
162756|NCT01314703|O2|Outcome|70% Isopropyl Alcohol, 10.5 mL Applicator|All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
162757|NCT01314703|O1|Outcome|ChloraPrep One Step, 10.5 mL Applicator|All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
162758|NCT01314703|E1|Reported Event|Group 1|All subjects received treatment with both the test article and the positive control
162759|NCT01314443|B5|Baseline|Total|Total of all reporting groups
162760|NCT01314443|B4|Baseline|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
162761|NCT01314443|B3|Baseline|Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
162762|NCT01314443|B2|Baseline|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
162763|NCT01314443|B1|Baseline|Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162764|NCT01314443|P4|Participant Flow|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162765|NCT01314443|P3|Participant Flow|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162766|NCT01314443|P2|Participant Flow|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
162767|NCT01314443|P1|Participant Flow|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162768|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162769|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162770|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
162771|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162772|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162773|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162774|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
163178|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
162775|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162776|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162777|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162778|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
162779|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162780|NCT01314443|E4|Reported Event|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162781|NCT01314443|E3|Reported Event|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
162782|NCT01314443|E2|Reported Event|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
162783|NCT01314443|E1|Reported Event|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
162784|NCT01314417|B1|Baseline|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162785|NCT01314417|P1|Participant Flow|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162786|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162787|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162788|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162789|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162790|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162791|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162792|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162793|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162794|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162795|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162796|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162797|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162798|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162799|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162800|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162801|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162802|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162803|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162804|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162805|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162806|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162807|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162808|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162809|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162810|NCT01314417|E1|Reported Event|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
162811|NCT01314261|B5|Baseline|Total|Total of all reporting groups
162812|NCT01314261|B4|Baseline|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162813|NCT01314261|B3|Baseline|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162814|NCT01314261|B2|Baseline|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162815|NCT01314261|B1|Baseline|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162816|NCT01314261|P4|Participant Flow|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162817|NCT01314261|P3|Participant Flow|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162818|NCT01314261|P2|Participant Flow|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162819|NCT01314261|P1|Participant Flow|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162820|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162821|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162822|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162823|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162824|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162825|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162826|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162827|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162828|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162829|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162830|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
163727|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
162831|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162832|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162833|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162834|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162835|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162836|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162837|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162838|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162839|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162840|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162841|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162842|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162843|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162844|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162845|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162846|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162847|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162848|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162849|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162850|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162851|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162852|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162853|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162854|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162855|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162856|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162857|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162858|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162859|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162860|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162861|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162862|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162863|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162864|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162865|NCT01314261|E4|Reported Event|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162866|NCT01314261|E3|Reported Event|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162867|NCT01314261|E2|Reported Event|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162868|NCT01314261|E1|Reported Event|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
162869|NCT01314118|B1|Baseline|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162889|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
180831|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
162870|NCT01314118|P1|Participant Flow|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162871|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162872|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162873|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162874|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162875|NCT01314118|E1|Reported Event|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
162876|NCT01314105|B3|Baseline|Total|Total of all reporting groups
162877|NCT01314105|B2|Baseline|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162878|NCT01314105|B1|Baseline|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162879|NCT01314105|P2|Participant Flow|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162880|NCT01314105|P1|Participant Flow|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162881|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162882|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162883|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162884|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162885|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162886|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162887|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162888|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162981|NCT01313858|B3|Baseline|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162890|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162891|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162892|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162893|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162894|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162895|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162896|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162897|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162898|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162899|NCT01314105|E2|Reported Event|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162900|NCT01314105|E1|Reported Event|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
162901|NCT01314014|B1|Baseline|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
162902|NCT01314014|P1|Participant Flow|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
162903|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
162904|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
162905|NCT01314014|E1|Reported Event|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
162906|NCT01314001|B7|Baseline|Total|Total of all reporting groups
162907|NCT01314001|B6|Baseline|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162908|NCT01314001|B5|Baseline|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
180832|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
162909|NCT01314001|B4|Baseline|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162910|NCT01314001|B3|Baseline|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162911|NCT01314001|B2|Baseline|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162912|NCT01314001|B1|Baseline|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162913|NCT01314001|P6|Participant Flow|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162914|NCT01314001|P5|Participant Flow|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162915|NCT01314001|P4|Participant Flow|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162916|NCT01314001|P3|Participant Flow|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162917|NCT01314001|P2|Participant Flow|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162918|NCT01314001|P1|Participant Flow|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162919|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162920|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162921|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162922|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162923|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162924|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162925|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162926|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162927|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162928|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162929|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162930|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162931|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162932|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162933|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162934|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
180833|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
162935|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162936|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162937|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162938|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162939|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162940|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162941|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162942|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162943|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162944|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162945|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162946|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162947|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162948|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162949|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162950|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162951|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162952|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162953|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162954|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162955|NCT01314001|E6|Reported Event|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162956|NCT01314001|E5|Reported Event|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
162957|NCT01314001|E4|Reported Event|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162958|NCT01314001|E3|Reported Event|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
162959|NCT01314001|E2|Reported Event|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162960|NCT01314001|E1|Reported Event|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
162961|NCT01313936|B3|Baseline|Total|Total of all reporting groups
163021|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
162962|NCT01313936|B2|Baseline|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162963|NCT01313936|B1|Baseline|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162964|NCT01313936|P2|Participant Flow|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162965|NCT01313936|P1|Participant Flow|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162966|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162967|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162968|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162969|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162970|NCT01313936|E2|Reported Event|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162971|NCT01313936|E1|Reported Event|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
162972|NCT01313923|B1|Baseline|Sirolimus|All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.
162973|NCT01313923|P1|Participant Flow|Sirolimus|There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.
162974|NCT01313923|O1|Outcome|Sirolimus (Formerly Known as Rapamycin)|No results. Study has been terminated by investigator.
162975|NCT01313923|E1|Reported Event|Sirolimus (Formerly Known as Rapamycin)|No results as study has been terminated early by the investigator.
162976|NCT01313884|B1|Baseline|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
162977|NCT01313884|P1|Participant Flow|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
162978|NCT01313884|O1|Outcome|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
162979|NCT01313884|E1|Reported Event|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
162980|NCT01313858|B4|Baseline|Total|Total of all reporting groups
180834|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
162982|NCT01313858|B2|Baseline|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162983|NCT01313858|B1|Baseline|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162984|NCT01313858|P3|Participant Flow|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162985|NCT01313858|P2|Participant Flow|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162986|NCT01313858|P1|Participant Flow|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162987|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162988|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162989|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162990|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162991|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162992|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162993|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162994|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162995|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162996|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
162997|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
162998|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
162999|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
163000|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
163001|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
163002|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
163003|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
163004|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
163005|NCT01313858|E1|Reported Event|All Participants|Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
163006|NCT01313780|B3|Baseline|Total|Total of all reporting groups
163007|NCT01313780|B2|Baseline|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
163008|NCT01313780|B1|Baseline|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
163009|NCT01313780|P2|Participant Flow|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
163010|NCT01313780|P1|Participant Flow|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
163011|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
163012|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
163013|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
163014|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
163015|NCT01313780|E2|Reported Event|Oxycodone|oxycodone : Trade name is Oxycontin
163016|NCT01313780|E1|Reported Event|Oxycodone and Naloxone|Oxycodone and naloxone: Trade name is TARGIN.
163017|NCT01313728|B1|Baseline|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
163018|NCT01313728|P1|Participant Flow|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
163019|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
163020|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163022|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163023|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
163024|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163025|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
163026|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163027|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
163028|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163029|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
163030|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
163031|NCT01313728|E1|Reported Event|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
163032|NCT01313689|B3|Baseline|Total|Total of all reporting groups
163033|NCT01313689|B2|Baseline|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163034|NCT01313689|B1|Baseline|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163035|NCT01313689|P4|Participant Flow|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163036|NCT01313689|P3|Participant Flow|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163037|NCT01313689|P2|Participant Flow|Physician's Choice|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163046|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163038|NCT01313689|P1|Participant Flow|Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163039|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163040|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163041|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163042|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163043|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163044|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163045|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163109|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163179|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163047|NCT01313689|O3|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163048|NCT01313689|O2|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163049|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163050|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163051|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163052|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163053|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163054|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163110|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163111|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163055|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163056|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163057|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163058|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163059|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163060|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163061|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163062|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163180|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
163181|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
163063|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163064|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163065|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163066|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163067|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163068|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163069|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163070|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163112|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period
163182|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163071|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163072|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163073|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163074|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163075|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163076|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163077|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163078|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163113|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163183|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163079|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163080|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163081|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163082|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163083|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163084|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163085|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163086|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163114|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163184|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
163087|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163088|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163089|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163090|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163091|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163092|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163093|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163094|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163115|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163185|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
163095|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163096|NCT01313689|E4|Reported Event|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163097|NCT01313689|E3|Reported Event|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163098|NCT01313689|E2|Reported Event|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
163099|NCT01313689|E1|Reported Event|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
163100|NCT01313676|B5|Baseline|Total|Total of all reporting groups
163101|NCT01313676|B4|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163102|NCT01313676|B3|Baseline|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163103|NCT01313676|B2|Baseline|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163104|NCT01313676|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163105|NCT01313676|P4|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163106|NCT01313676|P3|Participant Flow|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163107|NCT01313676|P2|Participant Flow|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163108|NCT01313676|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163186|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
180835|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
163116|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163117|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163118|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163119|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163120|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163121|NCT01313676|E4|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163122|NCT01313676|E3|Reported Event|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163123|NCT01313676|E2|Reported Event|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163124|NCT01313676|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
163125|NCT01313663|B3|Baseline|Total|Total of all reporting groups
163126|NCT01313663|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163127|NCT01313663|B1|Baseline|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163128|NCT01313663|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163129|NCT01313663|P1|Participant Flow|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163130|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163131|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163132|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163133|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163149|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163134|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163135|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163136|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163137|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163138|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163139|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163140|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163141|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163142|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163143|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163144|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163145|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163146|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163147|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163148|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163174|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
180836|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
163150|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163151|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163152|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163153|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163154|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163155|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163156|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163157|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163158|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163159|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163160|NCT01313663|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163161|NCT01313663|E1|Reported Event|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
163162|NCT01313650|B5|Baseline|Total|Total of all reporting groups
163163|NCT01313650|B4|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163164|NCT01313650|B3|Baseline|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
163165|NCT01313650|B2|Baseline|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
163166|NCT01313650|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163167|NCT01313650|P4|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163168|NCT01313650|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
163169|NCT01313650|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.
163170|NCT01313650|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
163171|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163172|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
163173|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
163187|NCT01313650|E4|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
163188|NCT01313650|E3|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
163189|NCT01313650|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
163190|NCT01313650|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163191|NCT01313637|B5|Baseline|Total|Total of all reporting groups
163192|NCT01313637|B4|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163193|NCT01313637|B3|Baseline|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163194|NCT01313637|B2|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163195|NCT01313637|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
163196|NCT01313637|P4|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163197|NCT01313637|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
163198|NCT01313637|P2|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
163199|NCT01313637|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
163200|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163201|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163202|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163203|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163204|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163205|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163206|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163207|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163208|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163209|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163210|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163211|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163212|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163213|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163214|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163215|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163216|NCT01313637|E4|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
163217|NCT01313637|E3|Reported Event|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
163218|NCT01313637|E2|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
163219|NCT01313637|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
163220|NCT01313624|B3|Baseline|Total|Total of all reporting groups
163221|NCT01313624|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163222|NCT01313624|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163223|NCT01313624|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163224|NCT01313624|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163225|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163226|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163227|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163275|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163276|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163228|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163229|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163230|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163231|NCT01313624|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163232|NCT01313624|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163233|NCT01313624|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163234|NCT01313624|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
163235|NCT01313520|B3|Baseline|Total|Total of all reporting groups
163236|NCT01313520|B2|Baseline|Placebo|saline via intravenous infusion
163237|NCT01313520|B1|Baseline|Infliximab|3 mg/kg of Infliximab intravenous infusion
163238|NCT01313520|P2|Participant Flow|Placebo|saline via intravenous infusion
163239|NCT01313520|P1|Participant Flow|Infliximab|3 mg/kg of Infliximab intravenous infusion
163240|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163241|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
163242|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163243|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
163244|NCT01313520|O2|Outcome|Placebo|Saline via intravenous infusion
163245|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
163246|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163247|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
163248|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163249|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
163250|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163251|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
163252|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163253|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
163254|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
163255|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
163256|NCT01313520|E2|Reported Event|Placebo|saline via intravenous infusion
163257|NCT01313520|E1|Reported Event|Infliximab|3 mg/kg of Infliximab intravenous infusion
163258|NCT01313494|B3|Baseline|Total|Total of all reporting groups
163259|NCT01313494|B2|Baseline|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163260|NCT01313494|B1|Baseline|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163261|NCT01313494|P2|Participant Flow|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163262|NCT01313494|P1|Participant Flow|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163263|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163264|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163265|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163266|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163267|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163268|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163269|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163270|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163271|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163272|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163273|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163274|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163278|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163279|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163280|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163281|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163282|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163283|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163284|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163285|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163286|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163287|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163288|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163289|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163290|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163291|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163292|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163293|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163294|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163295|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163296|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163297|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163298|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163299|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163300|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163301|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163302|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163303|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163304|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163305|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163306|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163307|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163308|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163309|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163310|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163311|NCT01313494|E2|Reported Event|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
163312|NCT01313494|E1|Reported Event|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
163313|NCT01313299|B4|Baseline|Total|Total of all reporting groups
163314|NCT01313299|B3|Baseline|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163315|NCT01313299|B2|Baseline|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163316|NCT01313299|B1|Baseline|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163317|NCT01313299|P3|Participant Flow|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163318|NCT01313299|P2|Participant Flow|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163319|NCT01313299|P1|Participant Flow|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163320|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163321|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163322|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163323|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163324|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163325|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163326|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163327|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163328|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163329|NCT01313299|E3|Reported Event|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
163330|NCT01313299|E2|Reported Event|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
163331|NCT01313299|E1|Reported Event|Placebo|Placebo intramuscular injection single treatment cycle on day 1
163332|NCT01313273|B3|Baseline|Total|Total of all reporting groups
163333|NCT01313273|B2|Baseline|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163334|NCT01313273|B1|Baseline|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163335|NCT01313273|P2|Participant Flow|Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163336|NCT01313273|P1|Participant Flow|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
163337|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163338|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163339|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163340|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163341|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163342|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163343|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163344|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163345|NCT01313273|E2|Reported Event|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163346|NCT01313273|E1|Reported Event|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
163347|NCT01313221|B4|Baseline|Total|Total of all reporting groups
163348|NCT01313221|B3|Baseline|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
163349|NCT01313221|B2|Baseline|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163350|NCT01313221|B1|Baseline|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163351|NCT01313221|P3|Participant Flow|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
163352|NCT01313221|P2|Participant Flow|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163353|NCT01313221|P1|Participant Flow|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163354|NCT01313221|O2|Outcome|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
163355|NCT01313221|O1|Outcome|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
163356|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163357|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163358|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163359|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163360|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163361|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163362|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163363|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163364|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
180837|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
163365|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163366|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163367|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163368|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163369|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163370|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163371|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163372|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163373|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163374|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163375|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163376|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163377|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163378|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163379|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163380|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163381|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163382|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163383|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163384|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163385|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163386|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163387|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163388|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163389|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163390|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163391|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163392|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163393|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163394|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163395|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163396|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
180838|NCT01255592|O2|Outcome|Placebo|Placebo bd
163397|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163398|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
163399|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
163400|NCT01313221|E2|Reported Event|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
163401|NCT01313221|E1|Reported Event|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
163402|NCT01313208|B3|Baseline|Total|Total of all reporting groups
163403|NCT01313208|B2|Baseline|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
163404|NCT01313208|B1|Baseline|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
163405|NCT01313208|P2|Participant Flow|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
163406|NCT01313208|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
163407|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163408|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163409|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163410|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163411|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163412|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163413|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163414|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163415|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163416|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163417|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163418|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163419|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163420|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163421|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163422|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163423|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163424|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163425|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163426|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163427|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163428|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163429|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163549|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163430|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163431|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163432|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163433|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163434|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163435|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163436|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163437|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163438|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163439|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163440|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163441|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163442|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163443|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163444|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163445|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163446|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163447|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163448|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163449|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163450|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163451|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163452|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163453|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163454|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163455|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163456|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163457|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163458|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163459|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163460|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163461|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163462|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163463|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163464|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163588|NCT01312428|B3|Baseline|Total|Total of all reporting groups
163465|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163466|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163467|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163468|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163469|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163470|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163471|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163472|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163473|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163474|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163475|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163476|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163477|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163478|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163479|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163480|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163481|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163482|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163483|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163484|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163485|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
163486|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
163487|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
163488|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
163489|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
163490|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
163491|NCT01313208|E2|Reported Event|Etanercept-Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
163492|NCT01313208|E1|Reported Event|Placebo-Etanercept|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
163493|NCT01313182|B3|Baseline|Total|Total of all reporting groups
163494|NCT01313182|B2|Baseline|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
163495|NCT01313182|B1|Baseline|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
163496|NCT01313182|P2|Participant Flow|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
180839|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
163497|NCT01313182|P1|Participant Flow|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
163498|NCT01313182|O2|Outcome|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
163499|NCT01313182|O1|Outcome|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
163500|NCT01313182|E2|Reported Event|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
163501|NCT01313182|E1|Reported Event|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
163502|NCT01313117|B1|Baseline|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163503|NCT01313117|P1|Participant Flow|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163504|NCT01313117|O1|Outcome|Alpha Lipoic Acid|The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.
163505|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163506|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163507|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163508|NCT01313117|E1|Reported Event|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
163509|NCT01313078|B1|Baseline|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
163510|NCT01313078|P1|Participant Flow|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
163511|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
163512|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
163513|NCT01313078|E1|Reported Event|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
163514|NCT01313039|B1|Baseline|AZD6244|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
163515|NCT01313039|P1|Participant Flow|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
163516|NCT01313039|O1|Outcome|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
163517|NCT01313039|E1|Reported Event|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
163518|NCT01312948|B1|Baseline|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
163519|NCT01312948|P1|Participant Flow|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
163520|NCT01312948|O2|Outcome|Usual Mask|Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
163521|NCT01312948|O1|Outcome|Pixi Paediatric Mask|Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
163522|NCT01312948|O2|Outcome|Usual Mask|Usability (overall performance) score of the child's usual CPAP mask
163523|NCT01312948|O1|Outcome|Pixi Paediatric Mask Usability|Usability (overall performance) score of the Pixi paediatric mask
163524|NCT01312948|E1|Reported Event|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
163548|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163780|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163525|NCT01312818|B1|Baseline|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163526|NCT01312818|P1|Participant Flow|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163527|NCT01312818|O1|Outcome|Chemotherapy|"Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163528|NCT01312818|O1|Outcome|ALL Treated Patients|"List of toxicities in acute lymphoblastic leukemia (ALL) patients treated with bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163529|NCT01312818|O1|Outcome|ALL Treated Patients|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163530|NCT01312818|E1|Reported Event|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
163531|NCT01312805|B3|Baseline|Total|Total of all reporting groups
163532|NCT01312805|B2|Baseline|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
163533|NCT01312805|B1|Baseline|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
163534|NCT01312805|P2|Participant Flow|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
163535|NCT01312805|P1|Participant Flow|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
163536|NCT01312805|O2|Outcome|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
163537|NCT01312805|O1|Outcome|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
163538|NCT01312805|E2|Reported Event|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
163539|NCT01312805|E1|Reported Event|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
163540|NCT01312766|B3|Baseline|Total|Total of all reporting groups
163541|NCT01312766|B2|Baseline|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163542|NCT01312766|B1|Baseline|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163543|NCT01312766|P2|Participant Flow|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163544|NCT01312766|P1|Participant Flow|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163545|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163546|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163547|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163550|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163551|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163552|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163553|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163554|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163555|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163556|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163557|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163558|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163559|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163560|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163561|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163562|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163563|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163564|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163565|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163566|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163567|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163568|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163569|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163570|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163571|NCT01312766|E2|Reported Event|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
163572|NCT01312766|E1|Reported Event|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
163573|NCT01312519|B3|Baseline|Total|Total of all reporting groups
163574|NCT01312519|B2|Baseline|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
163575|NCT01312519|B1|Baseline|Manual Bone Marrow Sampling Device|Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
163576|NCT01312519|P2|Participant Flow|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
163577|NCT01312519|P1|Participant Flow|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
163578|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
163579|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
163580|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
163581|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
163582|NCT01312519|E2|Reported Event|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
163583|NCT01312519|E1|Reported Event|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
163584|NCT01312467|B1|Baseline|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
163585|NCT01312467|P1|Participant Flow|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
163586|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
163587|NCT01312467|E1|Reported Event|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
163589|NCT01312428|B2|Baseline|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
163590|NCT01312428|B1|Baseline|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
163591|NCT01312428|P2|Participant Flow|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
163592|NCT01312428|P1|Participant Flow|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
163593|NCT01312428|O2|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
163594|NCT01312428|O1|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
163595|NCT01312428|E2|Reported Event|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
163596|NCT01312428|E1|Reported Event|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
163597|NCT01312272|B3|Baseline|Total|Total of all reporting groups
163598|NCT01312272|B2|Baseline|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163599|NCT01312272|B1|Baseline|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163600|NCT01312272|P2|Participant Flow|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163601|NCT01312272|P1|Participant Flow|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163602|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163603|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163604|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163605|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163606|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163607|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163608|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
164473|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
163609|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163610|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163611|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163612|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163613|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163614|NCT01312272|E2|Reported Event|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
163615|NCT01312272|E1|Reported Event|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
163616|NCT01312129|B3|Baseline|Total|Total of all reporting groups
163617|NCT01312129|B2|Baseline|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
163618|NCT01312129|B1|Baseline|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
163619|NCT01312129|P2|Participant Flow|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
163620|NCT01312129|P1|Participant Flow|Placebo First, Then Sulfasalzine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
163621|NCT01312129|O2|Outcome|Sulfasalazine|Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
163622|NCT01312129|O1|Outcome|Placebo|Placebo x 3 doses 12 hours apart
163623|NCT01312129|E2|Reported Event|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
163624|NCT01312129|E1|Reported Event|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
163625|NCT01312038|B3|Baseline|Total|Total of all reporting groups
163626|NCT01312038|B2|Baseline|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
163627|NCT01312038|B1|Baseline|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
163628|NCT01312038|P2|Participant Flow|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
163629|NCT01312038|P1|Participant Flow|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
163630|NCT01312038|O2|Outcome|Placebo|Outcome measure in each evaluable ear
163631|NCT01312038|O1|Outcome|Simethicone-treated|Outcome measure in each evaluable ear.
163632|NCT01312038|E2|Reported Event|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
163633|NCT01312038|E1|Reported Event|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
163634|NCT01311687|B3|Baseline|Total|Total of all reporting groups
163635|NCT01311687|B2|Baseline|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163636|NCT01311687|B1|Baseline|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163637|NCT01311687|P2|Participant Flow|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163723|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163724|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163638|NCT01311687|P1|Participant Flow|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163639|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163640|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163641|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163642|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163643|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163644|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163645|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163646|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163647|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163648|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163649|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163650|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163651|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163652|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163653|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163654|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163655|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163656|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163657|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163658|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163659|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163725|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
180840|NCT01255592|E2|Reported Event|Placebo|Placebo for AZD5069 bd
163660|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163661|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163662|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163663|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163664|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163665|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163666|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163667|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163668|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163669|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163670|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163671|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163672|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163673|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163674|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163675|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163676|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163677|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163678|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163679|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163680|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163681|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163726|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163682|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163683|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163684|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163685|NCT01311687|E2|Reported Event|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
163686|NCT01311687|E1|Reported Event|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
163687|NCT01311661|B1|Baseline|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
163688|NCT01311661|P1|Participant Flow|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
163689|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163690|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163691|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163692|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163693|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163694|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163695|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163696|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163697|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163698|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163699|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163700|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163701|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163702|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163703|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163704|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163705|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163706|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163707|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163708|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163709|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163710|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163711|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163712|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163713|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163714|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163715|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163716|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163717|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163718|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163719|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163720|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163721|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163722|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163728|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163729|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163730|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163731|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163732|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163733|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163734|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163735|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163736|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163737|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163738|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163739|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163740|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163741|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163742|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163743|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163744|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163745|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163746|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163747|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163748|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163749|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163750|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163751|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163752|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163753|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163754|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163755|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163756|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163757|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163758|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163759|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163760|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163761|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163762|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163763|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163764|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163765|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163766|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163767|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163768|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163769|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163770|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163771|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163772|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163773|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163774|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163775|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163776|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163777|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163778|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163779|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
180841|NCT01255592|E1|Reported Event|AZD5069|80 mg bd
163781|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163782|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163783|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163784|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163785|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163786|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163787|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163788|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163789|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163790|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163791|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163792|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163793|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163794|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163795|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163796|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163797|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163798|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163799|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163800|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163801|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163802|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163803|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163804|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163805|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163806|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163807|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163808|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163809|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163810|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163811|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163812|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163813|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163814|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163815|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163816|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163817|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163818|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163819|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163820|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163821|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163822|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163823|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163824|NCT01311661|E5|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163825|NCT01311661|E4|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
163826|NCT01311661|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
163827|NCT01311661|E2|Reported Event|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
163828|NCT01311661|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
163829|NCT01311557|B3|Baseline|Total|Total of all reporting groups
163830|NCT01311557|B2|Baseline|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163831|NCT01311557|B1|Baseline|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163832|NCT01311557|P2|Participant Flow|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
165144|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
163833|NCT01311557|P1|Participant Flow|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163834|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163835|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163836|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163837|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163838|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163839|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163840|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163841|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163842|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163843|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163844|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163845|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163846|NCT01311557|E2|Reported Event|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163847|NCT01311557|E1|Reported Event|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
163848|NCT01311505|B1|Baseline|Participants Eligible for Analysis|Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
163849|NCT01311505|P2|Participant Flow|Rimactane First, Then Myrin 2|Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
163850|NCT01311505|P1|Participant Flow|Myrin 2 First, Then Rimactane|Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.
163851|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163852|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163853|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163854|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163855|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163856|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163857|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163858|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163859|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163860|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163861|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163862|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163863|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
163864|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
163865|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
163866|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
163867|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
163868|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
163869|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
163870|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
165145|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
163871|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
163872|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
163873|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
163874|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
163875|NCT01311505|E2|Reported Event|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
163876|NCT01311505|E1|Reported Event|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
163877|NCT01311362|B1|Baseline|Ambrisentan|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
163878|NCT01311362|P1|Participant Flow|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
163879|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
163880|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
163881|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
163882|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
163883|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
163884|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
163885|NCT01311362|E3|Reported Event|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
163886|NCT01311362|E2|Reported Event|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
163887|NCT01311362|E1|Reported Event|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
163888|NCT01311102|B3|Baseline|Total|Total of all reporting groups
163889|NCT01311102|B2|Baseline|Normal Saline|Normal Saline : 1.33cc of normal saline
163890|NCT01311102|B1|Baseline|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
163891|NCT01311102|P2|Participant Flow|Normal Saline|Normal Saline : 1.33cc of normal saline
163892|NCT01311102|P1|Participant Flow|Lidocaine|Lidocaine : 1.33 cc of 2% liquid lidocaine
163893|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline infused in endo cervix and endometrium.
163894|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
163895|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
163896|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
163897|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
163898|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
163899|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
163900|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
163901|NCT01311102|E2|Reported Event|Normal Saline|Normal Saline : 1.33cc of normal saline
163902|NCT01311102|E1|Reported Event|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
163903|NCT01311024|B3|Baseline|Total|Total of all reporting groups
163904|NCT01311024|B2|Baseline|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
163905|NCT01311024|B1|Baseline|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
163906|NCT01311024|P2|Participant Flow|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
163907|NCT01311024|P1|Participant Flow|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
163926|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
163908|NCT01311024|O2|Outcome|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
163909|NCT01311024|O1|Outcome|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
163910|NCT01311024|E2|Reported Event|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
163911|NCT01311024|E1|Reported Event|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
163912|NCT01310855|B3|Baseline|Total|Total of all reporting groups
163913|NCT01310855|B2|Baseline|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
163914|NCT01310855|B1|Baseline|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
163915|NCT01310855|P2|Participant Flow|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
163916|NCT01310855|P1|Participant Flow|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
163917|NCT01310855|O2|Outcome|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
163918|NCT01310855|O1|Outcome|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
163919|NCT01310855|E2|Reported Event|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
163920|NCT01310855|E1|Reported Event|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
163921|NCT01310803|B3|Baseline|Total|Total of all reporting groups
163922|NCT01310803|B2|Baseline|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
163923|NCT01310803|B1|Baseline|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
163924|NCT01310803|P2|Participant Flow|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
163925|NCT01310803|P1|Participant Flow|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
163927|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
163928|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
163929|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
163930|NCT01310803|E2|Reported Event|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
163931|NCT01310803|E1|Reported Event|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
163932|NCT01310777|B4|Baseline|Total|Total of all reporting groups
163933|NCT01310777|B3|Baseline|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
163934|NCT01310777|B2|Baseline|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163935|NCT01310777|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163936|NCT01310777|P3|Participant Flow|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
163937|NCT01310777|P2|Participant Flow|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163938|NCT01310777|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163939|NCT01310777|O3|Outcome|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
163940|NCT01310777|O2|Outcome|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163941|NCT01310777|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163942|NCT01310777|E3|Reported Event|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
163943|NCT01310777|E2|Reported Event|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163944|NCT01310777|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
163945|NCT01310582|B3|Baseline|Total|Total of all reporting groups
163946|NCT01310582|B2|Baseline|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163947|NCT01310582|B1|Baseline|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163948|NCT01310582|P2|Participant Flow|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163949|NCT01310582|P1|Participant Flow|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163950|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163951|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163952|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163953|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163954|NCT01310582|E2|Reported Event|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163955|NCT01310582|E1|Reported Event|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
163956|NCT01310413|B7|Baseline|Total|Total of all reporting groups
163957|NCT01310413|B6|Baseline|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164179|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
163958|NCT01310413|B5|Baseline|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163959|NCT01310413|B4|Baseline|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163960|NCT01310413|B3|Baseline|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163961|NCT01310413|B2|Baseline|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163962|NCT01310413|B1|Baseline|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163963|NCT01310413|P7|Participant Flow|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163964|NCT01310413|P6|Participant Flow|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163965|NCT01310413|P5|Participant Flow|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163966|NCT01310413|P4|Participant Flow|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163967|NCT01310413|P3|Participant Flow|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163968|NCT01310413|P2|Participant Flow|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163969|NCT01310413|P1|Participant Flow|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164180|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
164697|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
163970|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163971|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163972|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163973|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163974|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163975|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163976|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163977|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164077|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163978|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163979|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163980|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163981|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163982|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163983|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163984|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163985|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163986|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164168|NCT01309997|O4|Outcome|Imatinib Nonresponders|Did not attain a SCR with imatinib
163987|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163988|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163989|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163990|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163991|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163992|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163993|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163994|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164011|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
181904|NCT01252095|E2|Reported Event|50 mg Dose|50 mg PG545/week
163995|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163996|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163997|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
163998|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
163999|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164000|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164001|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164002|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164023|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164169|NCT01309997|O3|Outcome|Imatinib Responders|Attained a SCR with imatinib
164170|NCT01309997|O2|Outcome|Rituximab Non-responders|Did not attain a SCR with rituximab
164003|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164004|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164005|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164006|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164007|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164008|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164009|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164010|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164076|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
181905|NCT01252095|E1|Reported Event|25 mg Dose|25 mg PG545/week
164012|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164013|NCT01310413|O1|Outcome|Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164014|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164015|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164016|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164017|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164018|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164019|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164020|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164021|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164022|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164171|NCT01309997|O1|Outcome|Rituximab Responders|Attained a SCR with rituximab
164172|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
164024|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164025|NCT01310413|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164026|NCT01310413|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164027|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164028|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164029|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164030|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164031|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164032|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164033|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164034|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164035|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164036|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164173|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
181906|NCT01251978|B3|Baseline|Total|Total of all reporting groups
164037|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164038|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164039|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164040|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164041|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164042|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164043|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164044|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164045|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164046|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164047|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164048|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164049|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164174|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
164264|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164050|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164051|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164052|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164053|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164054|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164055|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164056|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164057|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164058|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164059|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164060|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164061|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164062|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164175|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
164265|NCT01309841|E3|Reported Event|Placebo|
164266|NCT01309841|E2|Reported Event|NKTR-118 25 mg|
164063|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164064|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164065|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164066|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164067|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164068|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164069|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164070|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164071|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164072|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164073|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164074|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164075|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164267|NCT01309841|E1|Reported Event|NKTR-118 12.5 mg|
164078|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164079|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164080|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164081|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164082|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164083|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164084|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164085|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164086|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164087|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164088|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164089|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164090|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164176|NCT01309997|O2|Outcome|Arm II (Monocolonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
164268|NCT01309828|B3|Baseline|Total|Total of all reporting groups
164091|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164092|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164093|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164094|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164095|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164096|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164097|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164098|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164099|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164100|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164101|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164102|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164103|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164177|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
164381|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164104|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164105|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164106|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164107|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164108|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164109|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164110|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164111|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164112|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164113|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164114|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164115|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164116|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164178|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
164425|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164117|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164118|NCT01310413|E3|Reported Event|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
164119|NCT01310413|E2|Reported Event|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164120|NCT01310413|E1|Reported Event|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
164121|NCT01310400|B4|Baseline|Total|Total of all reporting groups
164122|NCT01310400|B3|Baseline|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164123|NCT01310400|B2|Baseline|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164124|NCT01310400|B1|Baseline|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
164125|NCT01310400|P3|Participant Flow|Agrippal 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
164126|NCT01310400|P2|Participant Flow|Inflexal V 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
164127|NCT01310400|P1|Participant Flow|Inflexal V 0.5 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
164128|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164129|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164130|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
164131|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
164132|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
164133|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
164134|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
164135|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
164136|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
164137|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
164138|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
164139|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
164140|NCT01310400|E3|Reported Event|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164141|NCT01310400|E2|Reported Event|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
164142|NCT01310400|E1|Reported Event|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
164143|NCT01310179|B1|Baseline|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
164472|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164144|NCT01310179|P1|Participant Flow|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
164145|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
164146|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
164147|NCT01310179|E1|Reported Event|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days..~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
164148|NCT01310127|B3|Baseline|Total|Total of all reporting groups
164149|NCT01310127|B2|Baseline|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164150|NCT01310127|B1|Baseline|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164151|NCT01310127|P2|Participant Flow|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164152|NCT01310127|P1|Participant Flow|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164153|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164154|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164155|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164156|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164157|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164158|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164159|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164160|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164161|NCT01310127|E2|Reported Event|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
164162|NCT01310127|E1|Reported Event|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
164163|NCT01309997|B3|Baseline|Total|Total of all reporting groups
164164|NCT01309997|B2|Baseline|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
164165|NCT01309997|B1|Baseline|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
164166|NCT01309997|P2|Participant Flow|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
164167|NCT01309997|P1|Participant Flow|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
164181|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
164182|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
164183|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
164184|NCT01309997|E4|Reported Event|Rituximab as Secondary Therapy|Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
164185|NCT01309997|E3|Reported Event|Imatinib as Secondary Therapy|Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
164186|NCT01309997|E2|Reported Event|Rituximab as Initial Therapy|Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
164187|NCT01309997|E1|Reported Event|Imatinib as Initial Therapy|Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
164188|NCT01309919|B3|Baseline|Total|Total of all reporting groups
164189|NCT01309919|B2|Baseline|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164190|NCT01309919|B1|Baseline|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164191|NCT01309919|P2|Participant Flow|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164192|NCT01309919|P1|Participant Flow|Intrauterine Device (IUD) Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164193|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164194|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164195|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164196|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164197|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164198|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164199|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164200|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164201|NCT01309919|E2|Reported Event|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
164202|NCT01309919|E1|Reported Event|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
164203|NCT01309893|B1|Baseline|Entire Study Population|All eligible enrolled participants
164204|NCT01309893|P2|Participant Flow|Air Optix Aqua Lens First, Then Investigational Lens|Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
164205|NCT01309893|P1|Participant Flow|Investigational Lens First, Then Air Optix Aqua Lens|Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
164206|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
164207|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
164208|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
164209|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
164210|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
164211|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
164212|NCT01309893|E2|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
164213|NCT01309893|E1|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
164214|NCT01309880|B1|Baseline|Overall Study|One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
164215|NCT01309880|P2|Participant Flow|Test Lens Then Air Optix Aqua|The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
164216|NCT01309880|P1|Participant Flow|Air Optix Aqua Then Test Lens|Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
164217|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
164218|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
164219|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
164220|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
164221|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
164222|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
164223|NCT01309880|E2|Reported Event|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
164224|NCT01309880|E1|Reported Event|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
164225|NCT01309841|B4|Baseline|Total|Total of all reporting groups
164226|NCT01309841|B3|Baseline|Placebo|Placebo QD, oral treatment
164227|NCT01309841|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164228|NCT01309841|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164229|NCT01309841|P3|Participant Flow|Placebo|Placebo QD, oral treatment
164230|NCT01309841|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164231|NCT01309841|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164232|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164233|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164234|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164235|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164236|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164237|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164238|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164239|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164240|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164241|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164242|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164243|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164244|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164245|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164246|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164247|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164248|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164249|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164250|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164251|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164252|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164253|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164254|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164255|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164256|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164257|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164258|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164259|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164260|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164261|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
164262|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
164263|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
164269|NCT01309828|B2|Baseline|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164270|NCT01309828|B1|Baseline|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164271|NCT01309828|P2|Participant Flow|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164272|NCT01309828|P1|Participant Flow|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164273|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164274|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164275|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164276|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164277|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164278|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164279|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164280|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164281|NCT01309828|E2|Reported Event|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
164282|NCT01309828|E1|Reported Event|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
164283|NCT01309737|B4|Baseline|Total|Total of all reporting groups
164284|NCT01309737|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164285|NCT01309737|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164286|NCT01309737|B1|Baseline|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164287|NCT01309737|P5|Participant Flow|Placebo,CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164288|NCT01309737|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164289|NCT01309737|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164290|NCT01309737|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164291|NCT01309737|P1|Participant Flow|CP-690,550 5mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
164292|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164293|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164294|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164295|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164296|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164297|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164298|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164299|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164300|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164301|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164302|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164303|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164304|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164305|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164306|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164307|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164308|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164309|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164310|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164311|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164312|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164313|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164314|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164315|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164316|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164317|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164318|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164319|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164320|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164321|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164322|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164323|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164324|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164325|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164326|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164327|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164328|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164329|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164330|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164331|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164332|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164333|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164334|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164335|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164336|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164337|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
183236|NCT01247220|B3|Baseline|Total|Total of all reporting groups
164338|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164339|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164340|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164341|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164342|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164343|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164344|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164345|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164346|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164347|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164348|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164349|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164350|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164351|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164352|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164353|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164354|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164355|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164356|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164357|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164358|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164359|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164360|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164361|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164362|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164363|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164364|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164365|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164366|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164367|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164368|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164369|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164370|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164371|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164372|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164373|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164374|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164375|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164376|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164377|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164378|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164379|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164380|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
184846|NCT01241513|B2|Baseline|Placebo|Placebo
164382|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164383|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164384|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164385|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164386|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164387|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164388|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164389|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164390|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164391|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164392|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164393|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164394|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164395|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164396|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164397|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164398|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164399|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164400|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164401|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164402|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164403|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164404|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164405|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164406|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164407|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164408|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164409|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164410|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164411|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164412|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164413|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164414|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164415|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164416|NCT01309737|O2|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164417|NCT01309737|O1|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164418|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164419|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164420|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164421|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164422|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164423|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164424|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
184847|NCT01241513|B1|Baseline|N-acetylcysteine (NAC)|NAC
164426|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164427|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164428|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164429|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164430|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164431|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164432|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164433|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164434|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164435|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164436|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164437|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164438|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164439|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164440|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164441|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164442|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164443|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164444|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164445|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164446|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164447|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164448|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164449|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164450|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164451|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
164452|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
164453|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164454|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164455|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164456|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164457|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164458|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164459|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164460|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164461|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164462|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164463|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164464|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164465|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164466|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164467|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164468|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164469|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164470|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164471|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164474|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164475|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164476|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164477|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
164478|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164479|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
164480|NCT01309737|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
164481|NCT01309737|E4|Reported Event|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
164482|NCT01309737|E3|Reported Event|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
164483|NCT01309737|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
164484|NCT01309737|E1|Reported Event|CP-690,550 5mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.
164485|NCT01309659|B3|Baseline|Total|Total of all reporting groups
164486|NCT01309659|B2|Baseline|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164487|NCT01309659|B1|Baseline|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164488|NCT01309659|P2|Participant Flow|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164489|NCT01309659|P1|Participant Flow|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164490|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164491|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164492|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164493|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164494|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164495|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164496|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164497|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164498|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164499|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164500|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164501|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164502|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164503|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164504|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164505|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164506|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164507|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164508|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164509|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164510|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164511|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164512|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164513|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164698|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164514|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164515|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164516|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164517|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164518|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164519|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164520|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164521|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164522|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164523|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164524|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164525|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164526|NCT01309659|E2|Reported Event|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164527|NCT01309659|E1|Reported Event|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
164528|NCT01309646|B3|Baseline|Total|Total of all reporting groups
164529|NCT01309646|B2|Baseline|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164571|NCT01309581|B1|Baseline|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164613|NCT01309360|B3|Baseline|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164530|NCT01309646|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164531|NCT01309646|P2|Participant Flow|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164532|NCT01309646|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164533|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164534|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164535|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164536|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164537|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164538|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164539|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164540|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164541|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164542|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164572|NCT01309581|P2|Participant Flow|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164771|NCT01308762|B3|Baseline|Group 3|IMM-101 1.0 mg
164543|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164544|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164545|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164546|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164547|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164548|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164549|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164550|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164551|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164552|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164553|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164554|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164555|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164573|NCT01309581|P1|Participant Flow|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164772|NCT01308762|B2|Baseline|Group 2|IMM-101 0.5 mg
164556|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164557|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164558|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164559|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164560|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164561|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164562|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164563|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164564|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164565|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164566|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164567|NCT01309646|E2|Reported Event|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164568|NCT01309646|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
164569|NCT01309581|B3|Baseline|Total|Total of all reporting groups
164570|NCT01309581|B2|Baseline|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164574|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164575|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164576|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164577|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
164578|NCT01309581|E2|Reported Event|Methohexitol|
164579|NCT01309581|E1|Reported Event|Ketamine|
164580|NCT01309451|B3|Baseline|Total|Total of all reporting groups
164581|NCT01309451|B2|Baseline|Combine Group|Bevacizumab plus Ozurdex
164582|NCT01309451|B1|Baseline|Bevacizumab Alone|Bevacizumab only
164583|NCT01309451|P2|Participant Flow|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
164584|NCT01309451|P1|Participant Flow|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
164585|NCT01309451|O2|Outcome|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
164586|NCT01309451|O1|Outcome|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
164587|NCT01309451|O2|Outcome|Combined Group|"Bevacizumab plus Ozurdex~Bevacizumab: intravitreal, 1.25mg., monthly~dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months"
164588|NCT01309451|O1|Outcome|Bevacizumab Alone|Bevacizumab: intravitreal, 1.25mg., monthly
164589|NCT01309451|E2|Reported Event|Combined Group|bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
164590|NCT01309451|E1|Reported Event|Bevacizumab Alone Group|bevacizumab 1.25mg intravitreally
164591|NCT01309386|B3|Baseline|Total|Total of all reporting groups
164592|NCT01309386|B2|Baseline|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164593|NCT01309386|B1|Baseline|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164594|NCT01309386|P2|Participant Flow|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164595|NCT01309386|P1|Participant Flow|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164596|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164597|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164598|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164599|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164600|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164601|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164602|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164603|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164604|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164605|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164606|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164607|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164608|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164609|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164610|NCT01309386|E2|Reported Event|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
164611|NCT01309386|E1|Reported Event|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
164612|NCT01309360|B4|Baseline|Total|Total of all reporting groups
164614|NCT01309360|B2|Baseline|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164615|NCT01309360|B1|Baseline|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
164616|NCT01309360|P3|Participant Flow|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164617|NCT01309360|P2|Participant Flow|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164618|NCT01309360|P1|Participant Flow|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
164619|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164620|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164621|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164622|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164623|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164624|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164625|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164626|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164627|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164628|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164629|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164630|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164631|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164632|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164633|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164634|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164635|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164636|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
164637|NCT01309360|E3|Reported Event|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
164638|NCT01309360|E2|Reported Event|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
164639|NCT01309360|E1|Reported Event|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
164640|NCT01309308|B3|Baseline|Total|Total of all reporting groups
164641|NCT01309308|B2|Baseline|No Sweeping Group|The patients who did not have sweeping of the membranes
164642|NCT01309308|B1|Baseline|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
164643|NCT01309308|P2|Participant Flow|No Sweeping Group|The patients who did not have sweeping of the membranes
164644|NCT01309308|P1|Participant Flow|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
164645|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
164646|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
164647|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
164648|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
164649|NCT01309308|E2|Reported Event|No Sweeping Group|The patients who did not have sweeping of the membranes
164650|NCT01309308|E1|Reported Event|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
164651|NCT01309282|B1|Baseline|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164652|NCT01309282|P1|Participant Flow|Rituximab|Participants with sero-positive [Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)] rheumatoid arthritis (RA), who had commenced therapy with rituximab (MabThera) following lack of response or intolerance to a single tumor necrosis factor (TNF)-inhibitor were included in this arm.
164653|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164654|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164655|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164656|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164696|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164657|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164658|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164659|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164660|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164661|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164662|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164663|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164664|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164665|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164666|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164667|NCT01309282|E1|Reported Event|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
164668|NCT01309269|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164669|NCT01309269|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164670|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164671|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164672|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164673|NCT01309269|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
164674|NCT01309243|B3|Baseline|Total|Total of all reporting groups
164675|NCT01309243|B2|Baseline|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164676|NCT01309243|B1|Baseline|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164677|NCT01309243|P2|Participant Flow|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164678|NCT01309243|P1|Participant Flow|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
164679|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164680|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164681|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164682|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164683|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164684|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164685|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164686|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164687|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164688|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164689|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164690|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164691|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164692|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164693|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164694|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164695|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164699|NCT01309243|E2|Reported Event|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
164700|NCT01309243|E1|Reported Event|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
164701|NCT01309204|B3|Baseline|Total|Total of all reporting groups
164702|NCT01309204|B2|Baseline|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164703|NCT01309204|B1|Baseline|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164704|NCT01309204|P2|Participant Flow|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164705|NCT01309204|P1|Participant Flow|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164706|NCT01309204|O2|Outcome|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164707|NCT01309204|O1|Outcome|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164708|NCT01309204|E2|Reported Event|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164709|NCT01309204|E1|Reported Event|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
164710|NCT01309100|B1|Baseline|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
164711|NCT01309100|P1|Participant Flow|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
164712|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
164713|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
164714|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
164715|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
164716|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
164717|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
164718|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
164719|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
164720|NCT01309100|E1|Reported Event|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
164721|NCT01308918|B1|Baseline|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164722|NCT01308918|P1|Participant Flow|GlideScope DLT Intubation With GlideRite DLT Stylet|The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l’Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
164773|NCT01308762|B1|Baseline|Group 1|IMM-101 0.1 mg
164969|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164723|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164724|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164725|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164726|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164727|NCT01308918|E1|Reported Event|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
164728|NCT01308840|B1|Baseline|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164729|NCT01308840|P1|Participant Flow|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164730|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164731|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164732|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164733|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164734|NCT01308840|E1|Reported Event|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
164735|NCT01308788|B3|Baseline|Total|Total of all reporting groups
164736|NCT01308788|B2|Baseline|Aqueous Outflow|aqueous outflow treated
164737|NCT01308788|B1|Baseline|Aqueous Suppressant|aqueous suppressant treated
164738|NCT01308788|P2|Participant Flow|Aqueous Suppressant|aqueous suppressant treated
164739|NCT01308788|P1|Participant Flow|Aqueous Outflow|aqueous outflow treated
164740|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164741|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164742|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164743|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164744|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164745|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164746|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164747|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164748|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164749|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164750|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164751|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164752|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164753|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164754|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164755|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164756|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164757|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164758|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164759|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164760|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164761|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164762|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164763|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164764|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164765|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164766|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
164767|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
164768|NCT01308788|E2|Reported Event|Aqueous Suppressant|aqueous suppressant treated
164769|NCT01308788|E1|Reported Event|Aqueous Outflow|aqueous outflow treated
164770|NCT01308762|B4|Baseline|Total|Total of all reporting groups
164774|NCT01308762|P3|Participant Flow|IMM-101 1.0 mg|Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
164775|NCT01308762|P2|Participant Flow|IMM-101 0.5 mg|Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
164776|NCT01308762|P1|Participant Flow|IMM-101 0.1 mg|Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
164777|NCT01308762|O3|Outcome|Group 3|IMM-101 1.0 mg
164778|NCT01308762|O2|Outcome|Group 2|IMM-101 0.5 mg
164779|NCT01308762|O1|Outcome|Group 1|IMM-101 0.1 mg
164780|NCT01308762|O3|Outcome|IMM-101 1.0 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
164781|NCT01308762|O2|Outcome|IMM-101 0.5 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
164782|NCT01308762|O1|Outcome|IMM-101 0.1 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
164783|NCT01308762|E3|Reported Event|Group 3|IMM-101 1.0 mg
164784|NCT01308762|E2|Reported Event|Group 2|IMM-101 0.5 mg
164785|NCT01308762|E1|Reported Event|Group 1|IMM-101 0.1 mg
164786|NCT01308736|B3|Baseline|Total|Total of all reporting groups
164787|NCT01308736|B2|Baseline|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
164788|NCT01308736|B1|Baseline|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
164789|NCT01308736|P2|Participant Flow|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
164790|NCT01308736|P1|Participant Flow|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
164791|NCT01308736|O2|Outcome|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
164792|NCT01308736|O1|Outcome|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
164793|NCT01308736|E2|Reported Event|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
164794|NCT01308736|E1|Reported Event|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
164795|NCT01308619|B3|Baseline|Total|Total of all reporting groups
164796|NCT01308619|B2|Baseline|Placebo|placebo
164797|NCT01308619|B1|Baseline|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
164798|NCT01308619|P2|Participant Flow|Placebo Capsules|Placebo capsules for 12 weeks
164799|NCT01308619|P1|Participant Flow|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
164800|NCT01308619|O2|Outcome|Placebo|placebo
164801|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
164802|NCT01308619|O2|Outcome|Placebo|placebo
164803|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
164804|NCT01308619|O2|Outcome|Treatment Failure|
164805|NCT01308619|O1|Outcome|Treatment Success|
164806|NCT01308619|O2|Outcome|Placebo|placebo
164807|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
164808|NCT01308619|E2|Reported Event|Placebo|placebo
164809|NCT01308619|E1|Reported Event|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
164810|NCT01308580|B3|Baseline|Total|Total of all reporting groups
164811|NCT01308580|B2|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164812|NCT01308580|B1|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164813|NCT01308580|P2|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164814|NCT01308580|P1|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164815|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164816|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164817|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164818|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164819|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164820|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164821|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164822|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164823|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164824|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164825|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164826|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164827|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164828|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164829|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164830|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164831|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164832|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164833|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164834|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164835|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164836|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164837|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164838|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164839|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164840|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164841|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164842|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164843|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164844|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164845|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164846|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164847|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164848|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164849|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164850|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
164851|NCT01308580|E2|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
164852|NCT01308580|E1|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
164853|NCT01308476|B3|Baseline|Total|Total of all reporting groups
164854|NCT01308476|B2|Baseline|Control Group|Control group with same medication but not receiving reminder SMS.
164855|NCT01308476|B1|Baseline|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164856|NCT01308476|P2|Participant Flow|Control Group|Control group with same medication but not receiving reminder SMS.
164857|NCT01308476|P1|Participant Flow|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164858|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164859|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164860|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164861|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164862|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164863|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164864|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164865|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164866|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164867|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164868|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164869|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164870|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164871|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164872|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
164873|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164874|NCT01308476|E2|Reported Event|Control Group|Control group with same medication but not receiving reminder SMS.
164875|NCT01308476|E1|Reported Event|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
164876|NCT01308450|B1|Baseline|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
164967|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164877|NCT01308450|P1|Participant Flow|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
164878|NCT01308450|O1|Outcome|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
164879|NCT01308450|E1|Reported Event|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
164880|NCT01308424|B3|Baseline|Total|Total of all reporting groups
164881|NCT01308424|B2|Baseline|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
164882|NCT01308424|B1|Baseline|Matching Placebo|Matching placebo : sublingual dosing for 7 days
164883|NCT01308424|P3|Participant Flow|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
164884|NCT01308424|P2|Participant Flow|Matching Placebo|Matching placebo : sublingual dosing for 7 days
164885|NCT01308424|P1|Participant Flow|Baseline Run In|Baseline period to assess eligibility before randomization
164886|NCT01308424|O2|Outcome|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
164887|NCT01308424|O1|Outcome|Matching Placebo|Matching placebo : sublingual dosing for 7 days
164888|NCT01308424|E3|Reported Event|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
164889|NCT01308424|E2|Reported Event|Matching Placebo|Matching placebo : sublingual dosing for 7 days
164890|NCT01308424|E1|Reported Event|Baseline Run In|Baseline period to assess eligibility before randomization
164891|NCT01307787|B3|Baseline|Total|Total of all reporting groups
164892|NCT01307787|B2|Baseline|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
164893|NCT01307787|B1|Baseline|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
164894|NCT01307787|P2|Participant Flow|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
164895|NCT01307787|P1|Participant Flow|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
164896|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164897|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
164898|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164899|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
164900|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164901|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
164902|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164903|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
164904|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164905|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
164906|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
164907|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
164908|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention. WLC was allowed to follow the program after the study.
164909|NCT01307787|O1|Outcome|Intervention Fit Program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
164910|NCT01307787|O2|Outcome|Waiting List Control Group|No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
164911|NCT01307787|O1|Outcome|Intervention Fit Program|An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
164912|NCT01307787|E2|Reported Event|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
164913|NCT01307787|E1|Reported Event|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
164914|NCT01307618|B3|Baseline|Total|Total of all reporting groups
164915|NCT01307618|B2|Baseline|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164916|NCT01307618|B1|Baseline|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164917|NCT01307618|P2|Participant Flow|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164918|NCT01307618|P1|Participant Flow|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164919|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164920|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164921|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164922|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164923|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164924|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164925|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164926|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164927|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164928|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164929|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164968|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164930|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164931|NCT01307618|E2|Reported Event|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164932|NCT01307618|E1|Reported Event|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
164933|NCT01307423|B4|Baseline|Total|Total of all reporting groups
164934|NCT01307423|B3|Baseline|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
164935|NCT01307423|B2|Baseline|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
164936|NCT01307423|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164937|NCT01307423|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
164938|NCT01307423|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
164939|NCT01307423|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years
164940|NCT01307423|P4|Participant Flow|Placebo/ 20mg Apremilast EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
164941|NCT01307423|P3|Participant Flow|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
164942|NCT01307423|P2|Participant Flow|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
164943|NCT01307423|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
164944|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164945|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164946|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164947|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164948|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164949|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164950|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164951|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164952|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164953|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164954|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164955|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164956|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164957|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164958|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164959|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164960|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164961|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164962|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164963|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164964|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164965|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164966|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164970|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164971|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164972|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164973|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164974|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164975|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164976|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164977|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164978|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164979|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164980|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164981|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164982|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164983|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164984|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164985|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
164986|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164987|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164988|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164989|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164990|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164991|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164992|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164993|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164994|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164995|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164996|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
164997|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
164998|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
164999|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165000|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165001|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165002|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165003|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165004|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165005|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165006|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165007|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165008|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165009|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165010|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165011|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165012|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165013|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165014|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165015|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165016|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165017|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165018|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165019|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165020|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165021|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165022|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165023|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165024|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165025|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165026|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165027|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165028|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165029|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165030|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165031|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165032|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165033|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165034|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
165035|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
165036|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165037|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
165038|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
165039|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
165040|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
165041|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
165042|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165043|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
165044|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
165045|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
165046|NCT01307423|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
165047|NCT01307423|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
165048|NCT01307423|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
165049|NCT01307423|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
165050|NCT01307423|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
165051|NCT01307319|B4|Baseline|Total|Total of all reporting groups
165052|NCT01307319|B3|Baseline|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
165053|NCT01307319|B2|Baseline|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165054|NCT01307319|B1|Baseline|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165055|NCT01307319|P3|Participant Flow|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
165143|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
184848|NCT01241513|P2|Participant Flow|Placebo|Placebo
165056|NCT01307319|P2|Participant Flow|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165057|NCT01307319|P1|Participant Flow|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165058|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
165059|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165060|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165061|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
165062|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165063|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165064|NCT01307319|E3|Reported Event|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
165065|NCT01307319|E2|Reported Event|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165066|NCT01307319|E1|Reported Event|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
165067|NCT01307111|B4|Baseline|Total|Total of all reporting groups
165068|NCT01307111|B3|Baseline|Not Randomized|Women not eligible to continue to randomization.
165069|NCT01307111|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
165070|NCT01307111|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
165071|NCT01307111|P2|Participant Flow|Placebo|"Pills which are identical to the study drug in appearance, taste, and smell.~Placebo: Pills which are identical to the study drug in appearance, taste, and smell."
165072|NCT01307111|P1|Participant Flow|Misoprostol|"Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.~Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion."
165073|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
165074|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
165075|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
165076|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
165077|NCT01307111|E2|Reported Event|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
165078|NCT01307111|E1|Reported Event|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
165079|NCT01307046|B3|Baseline|Total|Total of all reporting groups
165080|NCT01307046|B2|Baseline|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165081|NCT01307046|B1|Baseline|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165082|NCT01307046|P2|Participant Flow|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165083|NCT01307046|P1|Participant Flow|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165084|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165085|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165086|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165087|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165088|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165089|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165090|NCT01307046|E2|Reported Event|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
165091|NCT01307046|E1|Reported Event|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
165092|NCT01307033|B3|Baseline|Total|Total of all reporting groups
165093|NCT01307033|B2|Baseline|MK-0954A (L100/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
165094|NCT01307033|B1|Baseline|MK-0954H (L50/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
165095|NCT01307033|P4|Participant Flow|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
165096|NCT01307033|P3|Participant Flow|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
165097|NCT01307033|P2|Participant Flow|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
165098|NCT01307033|P1|Participant Flow|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
165099|NCT01307033|O2|Outcome|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
165100|NCT01307033|O1|Outcome|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
165101|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
165102|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
165103|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).
165104|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
165105|NCT01307033|E4|Reported Event|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
165106|NCT01307033|E3|Reported Event|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
165107|NCT01307033|E2|Reported Event|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
165108|NCT01307033|E1|Reported Event|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
165109|NCT01307020|B11|Baseline|Total|Total of all reporting groups
165110|NCT01307020|B10|Baseline|Placebo|Placebo oral film-coated tablet, once
165111|NCT01307020|B9|Baseline|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165112|NCT01307020|B8|Baseline|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165113|NCT01307020|B7|Baseline|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
165114|NCT01307020|B6|Baseline|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
165115|NCT01307020|B5|Baseline|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
165116|NCT01307020|B4|Baseline|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165117|NCT01307020|B3|Baseline|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165118|NCT01307020|B2|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165119|NCT01307020|B1|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165120|NCT01307020|P10|Participant Flow|Placebo|Placebo oral film-coated tablet, once
165121|NCT01307020|P9|Participant Flow|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165122|NCT01307020|P8|Participant Flow|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165123|NCT01307020|P7|Participant Flow|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
165124|NCT01307020|P6|Participant Flow|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
165125|NCT01307020|P5|Participant Flow|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
165126|NCT01307020|P4|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165127|NCT01307020|P3|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165128|NCT01307020|P2|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165129|NCT01307020|P1|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165130|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
165131|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165132|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165133|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
165134|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
165135|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
165136|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165137|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165138|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165139|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165140|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
165141|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165142|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165146|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165147|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165148|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165149|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165150|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
165151|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165152|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165153|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
165154|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
165155|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
165156|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165157|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165158|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165159|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165160|NCT01307020|E10|Reported Event|Placebo|Placebo oral film-coated tablet, once
165161|NCT01307020|E9|Reported Event|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
165162|NCT01307020|E8|Reported Event|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
165163|NCT01307020|E7|Reported Event|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
165164|NCT01307020|E6|Reported Event|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
165165|NCT01307020|E5|Reported Event|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
165166|NCT01307020|E4|Reported Event|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
165167|NCT01307020|E3|Reported Event|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165168|NCT01307020|E2|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
165169|NCT01307020|E1|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
165170|NCT01306968|B5|Baseline|Total|Total of all reporting groups
165171|NCT01306968|B4|Baseline|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165172|NCT01306968|B3|Baseline|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165173|NCT01306968|B2|Baseline|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165174|NCT01306968|B1|Baseline|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165175|NCT01306968|P4|Participant Flow|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165176|NCT01306968|P3|Participant Flow|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165177|NCT01306968|P2|Participant Flow|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165178|NCT01306968|P1|Participant Flow|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165179|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165235|NCT01306617|P1|Participant Flow|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165346|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165180|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165181|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165182|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165183|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165184|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165185|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165186|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165187|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165188|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165189|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)
165190|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165191|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165192|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165193|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165194|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165195|NCT01306968|E4|Reported Event|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
165236|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165237|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165238|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165196|NCT01306968|E3|Reported Event|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
165197|NCT01306968|E2|Reported Event|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
165198|NCT01306968|E1|Reported Event|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
165199|NCT01306877|B3|Baseline|Total|Total of all reporting groups
165200|NCT01306877|B2|Baseline|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165201|NCT01306877|B1|Baseline|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165202|NCT01306877|P2|Participant Flow|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set : Surgical device
165203|NCT01306877|P1|Participant Flow|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set : Surgical device
165204|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165205|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165206|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165207|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165208|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165209|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165210|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165211|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165212|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165213|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165214|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165215|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165216|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165217|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165218|NCT01306877|E2|Reported Event|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
165219|NCT01306877|E1|Reported Event|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
165220|NCT01306643|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165221|NCT01306643|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165222|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165223|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165224|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165225|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165226|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165227|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165228|NCT01306643|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
165229|NCT01306617|B4|Baseline|Total|Total of all reporting groups
165230|NCT01306617|B3|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165231|NCT01306617|B2|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165232|NCT01306617|B1|Baseline|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165233|NCT01306617|P3|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165234|NCT01306617|P2|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165301|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165239|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165240|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165241|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165242|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165243|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165244|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165245|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165246|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165247|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165248|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165249|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165250|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165251|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165252|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165253|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165254|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165255|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165256|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165257|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165258|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165259|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165260|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165261|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165262|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165263|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165264|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165345|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165265|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165266|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165267|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165268|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165269|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165270|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165271|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165272|NCT01306617|E3|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
165273|NCT01306617|E2|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165274|NCT01306617|E1|Reported Event|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
165275|NCT01306305|B3|Baseline|Total|Total of all reporting groups
165276|NCT01306305|B2|Baseline|Elderly|Elderly subjects aged over 60 years
165277|NCT01306305|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
165278|NCT01306305|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
165279|NCT01306305|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
165280|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165281|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165282|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165283|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165284|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165285|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165286|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165287|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165288|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165289|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165290|NCT01306305|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
165291|NCT01306305|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
165292|NCT01306292|B3|Baseline|Total|Total of all reporting groups
165293|NCT01306292|B2|Baseline|Normal Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
165294|NCT01306292|B1|Baseline|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
165295|NCT01306292|P4|Participant Flow|Normal Group (Placebo First, Then SonoVue)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
165296|NCT01306292|P3|Participant Flow|Normal Group (SonoVue First, Then Placebo)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
165297|NCT01306292|P2|Participant Flow|Hypertension Group (Placebo First, Then SonoVue)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
165298|NCT01306292|P1|Participant Flow|Hypertension Group (SonoVue First, Then Placebo)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
165299|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165300|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165464|NCT01305772|E1|Reported Event|Radiation Therapy|Radiation therapy with panitumumab therapy.
165302|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165303|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165304|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165305|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165306|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165307|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165308|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165309|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
165310|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
165311|NCT01306292|E2|Reported Event|Normal Pulmonary Pressure Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
165312|NCT01306292|E1|Reported Event|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
165313|NCT01306253|B3|Baseline|Total|Total of all reporting groups
165314|NCT01306253|B2|Baseline|Elderly|Elderly subjects aged over 60 years
165315|NCT01306253|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
165316|NCT01306253|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
165317|NCT01306253|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
165318|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165319|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165320|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165321|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165322|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165323|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165324|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165325|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165326|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
165327|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
165328|NCT01306253|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
165329|NCT01306253|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
165330|NCT01306214|B4|Baseline|Total|Total of all reporting groups
165331|NCT01306214|B3|Baseline|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165332|NCT01306214|B2|Baseline|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165333|NCT01306214|B1|Baseline|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165334|NCT01306214|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165335|NCT01306214|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165336|NCT01306214|P1|Participant Flow|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165337|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165338|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165339|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165340|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165341|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165342|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165343|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165344|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165347|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165348|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165349|NCT01306214|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
165350|NCT01306214|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
165351|NCT01306214|E1|Reported Event|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
165352|NCT01306201|B1|Baseline|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
165353|NCT01306201|P1|Participant Flow|Respiration Rate in GCF Patients|In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
165354|NCT01306201|O1|Outcome|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
165355|NCT01306201|O1|Outcome|Overall Study Population|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
165356|NCT01306201|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate derived from Transthoracic Impedance
165357|NCT01306201|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide Waveform|Respiration rate determined by manual overscoring of capnography waveforms
165358|NCT01306201|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration rate determined by novel plethysmographic analysis
165359|NCT01306201|E1|Reported Event|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
165360|NCT01306175|B1|Baseline|Study Total|"This was a randomised, two-period, cross-over trial, the two treatments administered were~A single dose of digoxin 0.5 mg on day 1~Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
165361|NCT01306175|P1|Participant Flow|Study Total|"This was a randomised, two-period cross-over trial, the two treatments administered were~A single dose of 0.5mg digoxin on day 1~empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
165362|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
165363|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
165364|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
165365|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
165366|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
165367|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
165368|NCT01306175|E2|Reported Event|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
165369|NCT01306175|E1|Reported Event|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
165370|NCT01306162|B5|Baseline|Total|Total of all reporting groups
165371|NCT01306162|B4|Baseline|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
165372|NCT01306162|B3|Baseline|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
165373|NCT01306162|B2|Baseline|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
165374|NCT01306162|B1|Baseline|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
165375|NCT01306162|P4|Participant Flow|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
165376|NCT01306162|P3|Participant Flow|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
165377|NCT01306162|P2|Participant Flow|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
165378|NCT01306162|P1|Participant Flow|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
165379|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
165380|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
165381|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
165382|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
165383|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
165384|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
165385|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
165386|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
165387|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
165388|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
165389|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
165390|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
165391|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
165392|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
165393|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
165394|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
165395|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
165396|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
165397|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
165398|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
165399|NCT01306162|E6|Reported Event|400mg DR + 400mg DR Bid 2h Later (TrtE2)|Dronedarone 400mg + Dronedarone 400mg bid given 2h later
165400|NCT01306162|E5|Reported Event|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
165401|NCT01306162|E4|Reported Event|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
165402|NCT01306162|E3|Reported Event|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
165403|NCT01306162|E2|Reported Event|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
165404|NCT01306162|E1|Reported Event|150mg DE (TrtA)|Dabigatran 150mg
165405|NCT01306032|B7|Baseline|Total|Total of all reporting groups
165406|NCT01306032|B6|Baseline|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165407|NCT01306032|B5|Baseline|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
165408|NCT01306032|B4|Baseline|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165409|NCT01306032|B3|Baseline|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
165410|NCT01306032|B2|Baseline|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165411|NCT01306032|B1|Baseline|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
165412|NCT01306032|P6|Participant Flow|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
165413|NCT01306032|P5|Participant Flow|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165414|NCT01306032|P4|Participant Flow|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
165415|NCT01306032|P3|Participant Flow|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165416|NCT01306032|P2|Participant Flow|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
165417|NCT01306032|P1|Participant Flow|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165418|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165419|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165420|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165421|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165422|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165423|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165424|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165425|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165426|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
165427|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165428|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165698|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165429|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165430|NCT01306032|O6|Outcome|BRCA-positive Ovarian Cancer: Crossover|
165431|NCT01306032|O5|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165432|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165433|NCT01306032|O3|Outcome|Triple-negative Breast Cancer: Crossover|
165434|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165435|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165436|NCT01306032|E8|Reported Event|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165437|NCT01306032|E7|Reported Event|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165438|NCT01306032|E6|Reported Event|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165439|NCT01306032|E5|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165440|NCT01306032|E4|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165441|NCT01306032|E3|Reported Event|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165442|NCT01306032|E2|Reported Event|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
165443|NCT01306032|E1|Reported Event|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
165444|NCT01305811|B3|Baseline|Total|Total of all reporting groups
165445|NCT01305811|B2|Baseline|Wait List|Wait list for 2 months then weekly acupuncture for four months
165446|NCT01305811|B1|Baseline|Bi-weekly Acupuncture Treatment|Bi-weekly acupuncture treatment for 6 months
165447|NCT01305811|P2|Participant Flow|Wait List|Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
165448|NCT01305811|P1|Participant Flow|Bi-weekly Acupuncture Treatment|Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
165449|NCT01305811|O2|Outcome|Wait List|"Wait list for 2 months.~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
165450|NCT01305811|O1|Outcome|Bi-weekly Acupuncture Treatment|"Bi-weekly acupuncture treatment~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
165451|NCT01305811|O2|Outcome|Wait List Then Weekly Acupuncture|group mean SF-36 P score at 6 months
165452|NCT01305811|O1|Outcome|Bi-Weekly Acupuncture|group mean SF-36 P score at 6 months
165453|NCT01305811|E2|Reported Event|Wait List|"Wait list for 2 months followed by 4 months of weekly acupuncture~No Adverse events were reported in the Wait list group"
165454|NCT01305811|E1|Reported Event|Bi-Weekly Acupuncture|"Bi-Weekly Acupuncture for 6 months~1 serious unexpected adverse event in the biweekly group: Subject’s practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter’s custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.~The practitioner will also follow up with subject’s PCP."
165455|NCT01305772|B3|Baseline|Total|Total of all reporting groups
165456|NCT01305772|B2|Baseline|Surgery|Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
165457|NCT01305772|B1|Baseline|Radiation Therapy|Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
165458|NCT01305772|P2|Participant Flow|Surgery|"Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT.~Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site)."
165459|NCT01305772|P1|Participant Flow|Radiation Therapy|"Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.~Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT."
165460|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
165461|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
165462|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
165463|NCT01305772|E2|Reported Event|Surgery|Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
165699|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
165465|NCT01305655|B1|Baseline|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values."
165466|NCT01305655|P1|Participant Flow|Glucarpidase Arm|In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
165467|NCT01305655|O1|Outcome|Glucarpidase Arm|47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
165468|NCT01305655|E1|Reported Event|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.~No serious effect reported."
165469|NCT01305577|B4|Baseline|Total|Total of all reporting groups
165470|NCT01305577|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165471|NCT01305577|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165472|NCT01305577|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165473|NCT01305577|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165474|NCT01305577|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165475|NCT01305577|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165476|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165477|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165478|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165479|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165480|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165481|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165482|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165483|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165484|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165485|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165486|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165487|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165488|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165489|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165490|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165491|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165532|NCT01305408|P1|Participant Flow|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165492|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165493|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165494|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165495|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165496|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165497|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165498|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165499|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165500|NCT01305577|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165501|NCT01305577|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165502|NCT01305577|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
165503|NCT01305564|B1|Baseline|Baseline Characteristics|All treated with Denali filter.
165504|NCT01305564|P1|Participant Flow|Denali Inferior Vena Cava Filter|"All subjects enrolled will receive the Denali vena cava filter.~Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube."
165505|NCT01305564|O1|Outcome|Filter Penetration at Retrieval|
165506|NCT01305564|O1|Outcome|Filter Penetration at Placement|
165507|NCT01305564|O1|Outcome|Filter Tilt|At Retrieval
165508|NCT01305564|O1|Outcome|Filter Tilt|At Implant
165509|NCT01305564|O1|Outcome|Filter Migration >2 cm|
165510|NCT01305564|O1|Outcome|Filter Fracture|
165511|NCT01305564|O1|Outcome|New or Worsening DVT|
165512|NCT01305564|O1|Outcome|Recurrent PE|
165513|NCT01305564|O1|Outcome|Clinical Success of Retrieval|
165514|NCT01305564|O1|Outcome|Technical Success of Retrieval|
165515|NCT01305564|O1|Outcome|Clinical Success of Placement|
165516|NCT01305564|O1|Outcome|Technical Success of Placement|Primary implant endpoint
165517|NCT01305564|E1|Reported Event|Serious Adverse Events|"Serious Adverse Events are reported for all 200 subjects and all serious events are reported.~Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events."
165518|NCT01305473|B1|Baseline|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165519|NCT01305473|P1|Participant Flow|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165520|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165521|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165522|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165523|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165524|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165525|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165526|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165527|NCT01305473|E1|Reported Event|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
165528|NCT01305408|B3|Baseline|Total|Total of all reporting groups
165529|NCT01305408|B2|Baseline|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165530|NCT01305408|B1|Baseline|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165531|NCT01305408|P2|Participant Flow|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165533|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165534|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165535|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165536|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165537|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165538|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165539|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165540|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165541|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165542|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165543|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165544|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165545|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165546|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165547|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165548|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165549|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165550|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165551|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165552|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165553|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165554|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165555|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165556|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165557|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165558|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165559|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165560|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165561|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165562|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165563|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165564|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
184849|NCT01241513|P1|Participant Flow|N-acetylcysteine|Active drug group
165565|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165566|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165567|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165568|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165569|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165570|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165571|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165572|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165573|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165574|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165575|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165576|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165577|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165578|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165579|NCT01305408|E2|Reported Event|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
165580|NCT01305408|E1|Reported Event|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
165581|NCT01305265|B3|Baseline|Total|Total of all reporting groups
165582|NCT01305265|B2|Baseline|Intervention Group|Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.
165583|NCT01305265|B1|Baseline|Control Group|Endotracheal tube cuff inflated using the inflate & palpate technique
165584|NCT01305265|P2|Participant Flow|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
165585|NCT01305265|P1|Participant Flow|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
165586|NCT01305265|O2|Outcome|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
165587|NCT01305265|O1|Outcome|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
165588|NCT01305265|E2|Reported Event|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
165589|NCT01305265|E1|Reported Event|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
165590|NCT01305239|B1|Baseline|Exemestane|25 mg oral tablet once a day
165591|NCT01305239|P1|Participant Flow|Exemestane|25 mg oral tablet once a day
165592|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
165593|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
165594|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
165595|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
165596|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
165597|NCT01305239|E1|Reported Event|Exemestane|25 mg oral tablet once a day
165598|NCT01305044|B3|Baseline|Total|Total of all reporting groups
165599|NCT01305044|B2|Baseline|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165600|NCT01305044|B1|Baseline|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165601|NCT01305044|P2|Participant Flow|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
184889|NCT01241240|B3|Baseline|Total|Total of all reporting groups
165602|NCT01305044|P1|Participant Flow|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165603|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165604|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165605|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165606|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165607|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165608|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165609|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165610|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165611|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165612|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165613|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165614|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165615|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165616|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165617|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165659|NCT01304693|E2|Reported Event|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
165660|NCT01304693|E1|Reported Event|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
165661|NCT01304641|B3|Baseline|Total|Total of all reporting groups
188729|NCT01227785|O1|Outcome|INCEPTA CRT-D|
165618|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165619|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165620|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165621|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165622|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165623|NCT01305044|E2|Reported Event|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
165624|NCT01305044|E1|Reported Event|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
165625|NCT01304966|B1|Baseline|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
165626|NCT01304966|P1|Participant Flow|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
165627|NCT01304966|O2|Outcome|HPV 11|Children with recurrent respiratory papillomatosis from HPV 11
165628|NCT01304966|O1|Outcome|HPV 6|Children with recurrent respiratory papillomatosis from HPV 6
165629|NCT01304966|O1|Outcome|Children With Recurrent Respiratory Papillomatosis|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
165630|NCT01304966|E1|Reported Event|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
165631|NCT01304706|B1|Baseline|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
165632|NCT01304706|P1|Participant Flow|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
165633|NCT01304706|O1|Outcome|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
165634|NCT01304706|E1|Reported Event|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
165635|NCT01304693|B6|Baseline|Total|Total of all reporting groups
165636|NCT01304693|B5|Baseline|Lucentis|Single intravitreal injection with 6-month follow-up
165637|NCT01304693|B4|Baseline|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
165638|NCT01304693|B3|Baseline|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
165639|NCT01304693|B2|Baseline|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
165640|NCT01304693|B1|Baseline|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
165641|NCT01304693|P5|Participant Flow|Lucentis|Single intravitreal injection with 6-month follow-up
165642|NCT01304693|P4|Participant Flow|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
165643|NCT01304693|P3|Participant Flow|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
165644|NCT01304693|P2|Participant Flow|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
165645|NCT01304693|P1|Participant Flow|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
165646|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
165647|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
165648|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
165649|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
165650|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
165651|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
165652|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
165653|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
165654|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
165655|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
165656|NCT01304693|E5|Reported Event|Lucentis|Single intravitreal injection with 6-month follow-up
165657|NCT01304693|E4|Reported Event|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
165658|NCT01304693|E3|Reported Event|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
165662|NCT01304641|B2|Baseline|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165663|NCT01304641|B1|Baseline|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165664|NCT01304641|P2|Participant Flow|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165665|NCT01304641|P1|Participant Flow|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165666|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165667|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165668|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165669|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165670|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165671|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165672|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165673|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165674|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165675|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165676|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165677|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165678|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165679|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165680|NCT01304641|E2|Reported Event|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
165681|NCT01304641|E1|Reported Event|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
165682|NCT01304589|B1|Baseline|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
165683|NCT01304589|P1|Participant Flow|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
165684|NCT01304589|O1|Outcome|Milnacipram|Crossover study
165685|NCT01304589|O1|Outcome|Milnacipram|Crossover study
165686|NCT01304589|O1|Outcome|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
165687|NCT01304589|O1|Outcome|Milnacipram|open-label study
165688|NCT01304589|E1|Reported Event|Milnacipram|Crossover study
165689|NCT01304329|B1|Baseline|Study Overall|This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments were separated by a washout period of at least 7 days.
165690|NCT01304329|P6|Participant Flow|Empa Plus Sim / Simvastatin Alone / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg"
165691|NCT01304329|P5|Participant Flow|Empa Plus Sim / Empa Alone / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg"
165692|NCT01304329|P4|Participant Flow|Simvastatin Alone / Empa Plus Sim / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg"
165693|NCT01304329|P3|Participant Flow|Simvastatin Alone / Empa Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
165694|NCT01304329|P2|Participant Flow|Empa Alone / Empa Plus Sim / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg"
165695|NCT01304329|P1|Participant Flow|Empa Alone / Simvastatin Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
165696|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165697|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
188737|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
165700|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165701|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
165702|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165703|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
165704|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165705|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
165706|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165707|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
165708|NCT01304329|E3|Reported Event|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
165709|NCT01304329|E2|Reported Event|Simvastatin Alone|40 mg simvastatin alone
165710|NCT01304329|E1|Reported Event|Empa Alone|25mg empagliflozin (empa) alone
165711|NCT01304277|B1|Baseline|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165712|NCT01304277|P1|Participant Flow|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165713|NCT01304277|O3|Outcome|Overall|Overall number of patients who experienced adverse events during the course of REP-082 study.
165714|NCT01304277|O2|Outcome|Replagal AF|Patients received 7 EOW infusions of treatment with Replagal AF from week 2 to week 14 in REP-082.
165715|NCT01304277|O1|Outcome|Replagal RB|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082.
165716|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165717|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165718|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165719|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165720|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165721|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
165722|NCT01304277|E1|Reported Event|Replagal® (0.2 mg/kg, IV, EOW)|Overall patients that participated in REP-082
165723|NCT01304238|B11|Baseline|Total|Total of all reporting groups
165724|NCT01304238|B10|Baseline|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165725|NCT01304238|B9|Baseline|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165726|NCT01304238|B8|Baseline|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165727|NCT01304238|B7|Baseline|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165728|NCT01304238|B6|Baseline|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165729|NCT01304238|B5|Baseline|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165730|NCT01304238|B4|Baseline|Fondaparinux|Participants treated with fondaparinux after HIT II
165731|NCT01304238|B3|Baseline|Danaparoid|Participants treated with danaparoid after HIT II
165732|NCT01304238|B2|Baseline|Lepirudin|Participants treated with lepirudin after HIT II
165733|NCT01304238|B1|Baseline|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165734|NCT01304238|P10|Participant Flow|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165735|NCT01304238|P9|Participant Flow|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165736|NCT01304238|P8|Participant Flow|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165737|NCT01304238|P7|Participant Flow|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165738|NCT01304238|P6|Participant Flow|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165739|NCT01304238|P5|Participant Flow|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165740|NCT01304238|P4|Participant Flow|Fondaparinux|Participants treated with fondaparinux after HIT II
165741|NCT01304238|P3|Participant Flow|Danaparoid|Participants treated with danaparoid after HIT II
165742|NCT01304238|P2|Participant Flow|Lepirudin|Participants treated with lepirudin after HIT II
165743|NCT01304238|P1|Participant Flow|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165744|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165745|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165746|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165747|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165748|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165749|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165750|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165751|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165752|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
165753|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165754|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165755|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165756|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165757|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165758|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165759|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165760|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165761|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165762|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
165763|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165764|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165765|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165766|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165767|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165768|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165769|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165770|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165771|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165772|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
165773|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165774|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165775|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165776|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165777|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165778|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165779|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165780|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165781|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165782|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
165783|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165784|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165785|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165786|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165787|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165788|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165789|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165790|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165791|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165792|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
165793|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165794|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165795|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165796|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165797|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165798|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165799|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165800|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
165801|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
165802|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
188738|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
165803|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165804|NCT01304238|E10|Reported Event|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
165805|NCT01304238|E9|Reported Event|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
165806|NCT01304238|E8|Reported Event|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
165807|NCT01304238|E7|Reported Event|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
165808|NCT01304238|E6|Reported Event|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
165809|NCT01304238|E5|Reported Event|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
165810|NCT01304238|E4|Reported Event|Fondaparinux|Participants treated with fondaparinux after HIT II
165811|NCT01304238|E3|Reported Event|Danaparoid|Participants treated with danaparoid after HIT II
165812|NCT01304238|E2|Reported Event|Lepirudin|Participants treated with lepirudin after HIT II
165813|NCT01304238|E1|Reported Event|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
165814|NCT01304147|B1|Baseline|Participants Treated|
165815|NCT01304147|P2|Participant Flow|Placebo, Then Ketamine|placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.
165816|NCT01304147|P1|Participant Flow|Ketamine Then Placebo|Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
165817|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
165818|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
165819|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
165820|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
165821|NCT01304147|E2|Reported Event|Placebo|
165822|NCT01304147|E1|Reported Event|Ketamine|
165823|NCT01303861|B6|Baseline|Total|Total of all reporting groups
165824|NCT01303861|B5|Baseline|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
165825|NCT01303861|B4|Baseline|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165826|NCT01303861|B3|Baseline|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165827|NCT01303861|B2|Baseline|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165828|NCT01303861|B1|Baseline|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165829|NCT01303861|P4|Participant Flow|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165880|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
165889|NCT01303627|B2|Baseline|Control|Control:Remifentanil stopped at the end of the surgery
188739|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
165830|NCT01303861|P3|Participant Flow|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165831|NCT01303861|P2|Participant Flow|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165832|NCT01303861|P1|Participant Flow|Varenicline|"This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165833|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165834|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165835|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165836|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165837|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165881|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165882|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165883|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
165884|NCT01303744|E4|Reported Event|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
166265|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
165838|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165839|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165840|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165841|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165842|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165843|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165844|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165845|NCT01303861|E5|Reported Event|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
165846|NCT01303861|E4|Reported Event|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165885|NCT01303744|E3|Reported Event|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165886|NCT01303744|E2|Reported Event|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165887|NCT01303744|E1|Reported Event|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
165888|NCT01303627|B3|Baseline|Total|Total of all reporting groups
165847|NCT01303861|E3|Reported Event|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
165848|NCT01303861|E2|Reported Event|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
165849|NCT01303861|E1|Reported Event|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
165850|NCT01303835|B3|Baseline|Total|Total of all reporting groups
165851|NCT01303835|B2|Baseline|Placebo|Randomized patients received placebo to be taken every night before bed.
165852|NCT01303835|B1|Baseline|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
165853|NCT01303835|P2|Participant Flow|Placebo|Randomized patients received placebo to be taken every night before bed.
165854|NCT01303835|P1|Participant Flow|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
165855|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
165856|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
165857|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
165858|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
165859|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
165860|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
165861|NCT01303835|E2|Reported Event|Placebo|Randomized patients received placebo to be taken every night before bed.
165862|NCT01303835|E1|Reported Event|Naltrexone|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
165863|NCT01303744|B5|Baseline|Total|Total of all reporting groups
165864|NCT01303744|B4|Baseline|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
165865|NCT01303744|B3|Baseline|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165866|NCT01303744|B2|Baseline|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165867|NCT01303744|B1|Baseline|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
165868|NCT01303744|P4|Participant Flow|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
165869|NCT01303744|P3|Participant Flow|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165870|NCT01303744|P2|Participant Flow|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165871|NCT01303744|P1|Participant Flow|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
165872|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
165873|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165874|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165875|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
165876|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
165877|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
165878|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
165879|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
188740|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
165890|NCT01303627|B1|Baseline|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
165891|NCT01303627|P2|Participant Flow|Control|Control:Remifentanil stopped at the end of the surgery
165892|NCT01303627|P1|Participant Flow|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
165893|NCT01303627|O2|Outcome|Control Group|Remifentanil stopped at the and of the surgery
165894|NCT01303627|O1|Outcome|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
165895|NCT01303627|E2|Reported Event|Control Group|Remifentanil stopped at the end of the surgery
165896|NCT01303627|E1|Reported Event|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
165897|NCT01303510|B3|Baseline|Total|Total of all reporting groups
165898|NCT01303510|B2|Baseline|Group B|Elderly subjects aged over 60 years
165899|NCT01303510|B1|Baseline|Group A|Adults from 18 to 60 years old inclusive
165900|NCT01303510|P2|Participant Flow|Group B|Elderly subjects aged over 60 years
165901|NCT01303510|P1|Participant Flow|Group A|Adults from 18 to 60 years old inclusive
165902|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
165903|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
165904|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
165905|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
165906|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
165907|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
165908|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
165909|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
165910|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
165911|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
165912|NCT01303510|E2|Reported Event|Group B|Elderly subjects aged over 60 years
165913|NCT01303510|E1|Reported Event|Group A|Adults from 18 to 60 years old inclusive
165914|NCT01303445|B1|Baseline|Entire Study Population|
165915|NCT01303445|P2|Participant Flow|CDAB Sequence|Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
165916|NCT01303445|P1|Participant Flow|ABCD Sequence|Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole
165917|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165918|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165919|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165920|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165921|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165922|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165923|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165924|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165925|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165926|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165927|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165928|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165929|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165930|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165931|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165932|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165933|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165934|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165935|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165936|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165937|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165938|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165939|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
165940|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165941|NCT01303445|E4|Reported Event|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
165942|NCT01303445|E3|Reported Event|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
165943|NCT01303445|E2|Reported Event|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
166021|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
165944|NCT01303445|E1|Reported Event|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
165945|NCT01303406|B3|Baseline|Total|Total of all reporting groups
165946|NCT01303406|B2|Baseline|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165947|NCT01303406|B1|Baseline|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165948|NCT01303406|P2|Participant Flow|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165949|NCT01303406|P1|Participant Flow|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165950|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165951|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165952|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165953|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165954|NCT01303406|E2|Reported Event|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165955|NCT01303406|E1|Reported Event|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
165956|NCT01303380|B1|Baseline|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
166022|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166023|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166024|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166025|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
165957|NCT01303380|P1|Participant Flow|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165958|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165959|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165960|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165961|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165962|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165963|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165964|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165965|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165966|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
166026|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
165967|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165968|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165969|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165970|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165971|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165972|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165973|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165974|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165975|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165976|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
166027|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166454|NCT01301742|E1|Reported Event|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
165977|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165978|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165979|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165980|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165981|NCT01303380|E1|Reported Event|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator’s discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
165982|NCT01303224|B5|Baseline|Total|Total of all reporting groups
165983|NCT01303224|B4|Baseline|Placebo|oral tablet, once daily
165984|NCT01303224|B3|Baseline|Ibodutant 10 mg|oral tablet, once daily
165985|NCT01303224|B2|Baseline|Ibodutant 3 mg|oral tablet, once daily
165986|NCT01303224|B1|Baseline|Ibodutant 1 mg|oral tablet, once daily
165987|NCT01303224|P4|Participant Flow|Placebo|oral tablet, once daily
165988|NCT01303224|P3|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
165989|NCT01303224|P2|Participant Flow|Ibodutant 3 mg|oral tablet, once daily
165990|NCT01303224|P1|Participant Flow|Ibodutant 1 mg|oral tablet, once daily
165991|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
165992|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
165993|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
165994|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
165995|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
165996|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
165997|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
165998|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
165999|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
166000|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
166001|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
166002|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
166003|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
166004|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
166005|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
166006|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
166007|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
166008|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
166009|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
166010|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
166011|NCT01303224|E4|Reported Event|Placebo|oral tablet, once daily
166012|NCT01303224|E3|Reported Event|Ibodutant 10 mg|oral tablet, once daily
166013|NCT01303224|E2|Reported Event|Ibodutant 3 mg|oral tablet, once daily
166014|NCT01303224|E1|Reported Event|Ibodutant 1 mg|oral tablet, once daily
166015|NCT01302938|B3|Baseline|Total|Total of all reporting groups
166016|NCT01302938|B2|Baseline|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166017|NCT01302938|B1|Baseline|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166018|NCT01302938|P2|Participant Flow|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166019|NCT01302938|P1|Participant Flow|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166020|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166028|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
166029|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166030|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166031|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
166032|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
166033|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
166034|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
166035|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166036|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166037|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166038|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166039|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166040|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166041|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166042|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166043|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166044|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166045|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166046|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166047|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166048|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166049|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166050|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166051|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166052|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166053|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166054|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166055|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166056|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166057|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166058|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166059|NCT01302938|E2|Reported Event|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
166060|NCT01302938|E1|Reported Event|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
166061|NCT01302899|B3|Baseline|Total|Total of all reporting groups
166062|NCT01302899|B2|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
166063|NCT01302899|B1|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
166064|NCT01302899|P2|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
166089|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166090|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166118|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166065|NCT01302899|P1|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
166066|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166067|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166068|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166069|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166070|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166071|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166072|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166073|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166074|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166075|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166076|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166077|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166078|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166079|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166080|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166081|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166082|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166083|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166084|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166085|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166086|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166087|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166088|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166262|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166091|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166092|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166093|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166094|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166095|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166096|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166097|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166098|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166099|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166100|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166101|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166102|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166103|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166104|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166105|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166106|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166107|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166108|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166109|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166110|NCT01302899|E4|Reported Event|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
166111|NCT01302899|E3|Reported Event|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166112|NCT01302899|E2|Reported Event|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
166113|NCT01302899|E1|Reported Event|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
166114|NCT01302860|B1|Baseline|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166115|NCT01302860|P1|Participant Flow|Canakinumab|Participants received body weight stratified dose of canakinumab 2 milligrams/kilogram (mg/kg) subcutaneous (s.c.) injection every 8 weeks.
166116|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166117|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
188741|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
166119|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166120|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166121|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166122|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166123|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166124|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166125|NCT01302860|E1|Reported Event|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
166126|NCT01302691|B3|Baseline|Total|Total of all reporting groups
166127|NCT01302691|B2|Baseline|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166128|NCT01302691|B1|Baseline|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166129|NCT01302691|P2|Participant Flow|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166130|NCT01302691|P1|Participant Flow|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166131|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166132|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166133|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166134|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166135|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166136|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166137|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166138|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166139|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166140|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166141|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166142|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166143|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166144|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166145|NCT01302691|E2|Reported Event|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166146|NCT01302691|E1|Reported Event|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
166147|NCT01302548|B3|Baseline|Total|Total of all reporting groups
166148|NCT01302548|B2|Baseline|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166149|NCT01302548|B1|Baseline|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166150|NCT01302548|P2|Participant Flow|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166151|NCT01302548|P1|Participant Flow|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166152|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166153|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166154|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166155|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166156|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166157|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166158|NCT01302548|E2|Reported Event|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
166159|NCT01302548|E1|Reported Event|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
166160|NCT01302483|B3|Baseline|Total|Total of all reporting groups
166161|NCT01302483|B2|Baseline|Lidocaine Injection|
166162|NCT01302483|B1|Baseline|Kovacaine Nasal Spray|
166163|NCT01302483|P2|Participant Flow|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
166164|NCT01302483|P1|Participant Flow|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
166165|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
166166|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
166167|NCT01302483|O2|Outcome|Lidocaine Injection|Blood Pressure Maximum Change from Baseline
166168|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Blood Pressure Maximum Change from Baseline
166169|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
166170|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
166171|NCT01302483|O2|Outcome|Lidocaine Injection|Duration of Soft Tissue Anesthesia
166172|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Duration of Soft Tissue Anesthesia
166173|NCT01302483|O2|Outcome|Lidocaine Injection|Number of subjects able to complete the dental procedure without rescue
166174|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Number of subjects able to complete the dental procedure without rescue
166175|NCT01302483|E2|Reported Event|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
166176|NCT01302483|E1|Reported Event|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
166177|NCT01302444|B3|Baseline|Total|Total of all reporting groups
166178|NCT01302444|B2|Baseline|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166179|NCT01302444|B1|Baseline|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166180|NCT01302444|P2|Participant Flow|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166181|NCT01302444|P1|Participant Flow|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166182|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166183|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166184|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166185|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166186|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166187|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166188|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166189|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166190|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166191|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166192|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166193|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166194|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166195|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166196|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166197|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166198|NCT01302444|E2|Reported Event|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
166199|NCT01302444|E1|Reported Event|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
166200|NCT01302418|B1|Baseline|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
166201|NCT01302418|P1|Participant Flow|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
166202|NCT01302418|O1|Outcome|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
166203|NCT01302418|E1|Reported Event|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
166204|NCT01302392|B3|Baseline|Total|Total of all reporting groups
166205|NCT01302392|B2|Baseline|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166263|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
167337|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
166206|NCT01302392|B1|Baseline|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166207|NCT01302392|P2|Participant Flow|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166208|NCT01302392|P1|Participant Flow|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166209|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166210|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166211|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166212|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166213|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166214|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166215|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166216|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166217|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166218|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166219|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166220|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166221|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166222|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166223|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166264|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166224|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166225|NCT01302392|E2|Reported Event|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
166226|NCT01302392|E1|Reported Event|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
166227|NCT01302366|B1|Baseline|Sea Cucumber Extract (TBL 12)|"TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.~TBL-12"
166228|NCT01302366|P1|Participant Flow|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
166229|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
166230|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
166231|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
166232|NCT01302366|E1|Reported Event|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
166233|NCT01302119|B3|Baseline|Total|Total of all reporting groups
166234|NCT01302119|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166235|NCT01302119|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166236|NCT01302119|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166237|NCT01302119|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166238|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166239|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166240|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166241|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166242|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166243|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166244|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166245|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166246|NCT01302119|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
166247|NCT01302119|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
166248|NCT01302067|B4|Baseline|Total|Total of all reporting groups
166249|NCT01302067|B3|Baseline|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166250|NCT01302067|B2|Baseline|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166251|NCT01302067|B1|Baseline|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166252|NCT01302067|P3|Participant Flow|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166253|NCT01302067|P2|Participant Flow|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166254|NCT01302067|P1|Participant Flow|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166255|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166256|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166257|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166258|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166259|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166260|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166261|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166266|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166267|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166268|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166269|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166270|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166271|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166272|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166273|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166274|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166275|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166276|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166277|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166278|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166279|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166280|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166281|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166282|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166283|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166284|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166285|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166286|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166287|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166288|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166289|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166290|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166291|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166292|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166293|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166294|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166295|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166296|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166297|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166298|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166299|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166300|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166301|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166302|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166303|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166304|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166305|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166306|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166307|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166308|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166309|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166310|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166311|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166312|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166313|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166314|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166315|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166316|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166317|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166318|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166319|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166320|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166321|NCT01302067|E3|Reported Event|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
166322|NCT01302067|E2|Reported Event|Placebo|Participants received one tablet of placebo per day for 12 weeks.
166323|NCT01302067|E1|Reported Event|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
166324|NCT01302054|B1|Baseline|Entire Study Population|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
166325|NCT01302054|P3|Participant Flow|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166326|NCT01302054|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166327|NCT01302054|P1|Participant Flow|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
166328|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166329|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166330|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166331|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166332|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166333|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166334|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166335|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166336|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166337|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166338|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166339|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166340|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166341|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166342|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166343|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166344|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166345|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166346|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166347|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
167338|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
166348|NCT01302054|O2|Outcome|Fesoterodine: Double-Blind Week 12|Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166349|NCT01302054|O1|Outcome|Fesoterodine: Double-Blind Baseline|Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166350|NCT01302054|E3|Reported Event|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
166351|NCT01302054|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
166352|NCT01302054|E1|Reported Event|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
166353|NCT01302041|B1|Baseline|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166354|NCT01302041|P1|Participant Flow|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166355|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166356|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166357|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166358|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166359|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166360|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166361|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166362|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166363|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166364|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166365|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166366|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166367|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166368|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166369|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166412|NCT01301833|B3|Baseline|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166370|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166371|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166372|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166373|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166374|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166375|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166376|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166377|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166378|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166379|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166380|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166381|NCT01302041|E1|Reported Event|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
166382|NCT01301963|B3|Baseline|Total|Total of all reporting groups
166383|NCT01301963|B2|Baseline|Arm II|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
166384|NCT01301963|B1|Baseline|Arm I|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
166385|NCT01301963|P2|Participant Flow|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
166386|NCT01301963|P1|Participant Flow|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
166387|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
166388|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
166389|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
166390|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
166391|NCT01301963|E2|Reported Event|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
166392|NCT01301963|E1|Reported Event|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
166393|NCT01301950|B3|Baseline|Total|Total of all reporting groups
166394|NCT01301950|B2|Baseline|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166395|NCT01301950|B1|Baseline|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon"
166413|NCT01301833|B2|Baseline|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166414|NCT01301833|B1|Baseline|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166415|NCT01301833|P4|Participant Flow|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
167339|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
166396|NCT01301950|P2|Participant Flow|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166397|NCT01301950|P1|Participant Flow|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166398|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166399|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166400|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166401|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166402|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166403|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166404|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166405|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166406|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions.~Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon."
166407|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166408|NCT01301950|E2|Reported Event|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
166409|NCT01301950|E1|Reported Event|TruMatch™ Personalized Solutions|"Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions~Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon"
166410|NCT01301833|B5|Baseline|Total|Total of all reporting groups
166411|NCT01301833|B4|Baseline|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166416|NCT01301833|P3|Participant Flow|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166417|NCT01301833|P2|Participant Flow|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166418|NCT01301833|P1|Participant Flow|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166419|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166420|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166421|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166422|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166423|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166424|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166425|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166426|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166427|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166428|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166429|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166430|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166431|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166432|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166433|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166434|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166435|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166436|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166437|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166438|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166439|NCT01301833|E4|Reported Event|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
166440|NCT01301833|E3|Reported Event|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
166441|NCT01301833|E2|Reported Event|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
166442|NCT01301833|E1|Reported Event|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
166443|NCT01301742|B1|Baseline|Entire Study Population|"The two treatments given in a randomised order were:~Empagliflozin 25mg (Empa) was given as a single dose on Day 1~Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.~Between treatments there was a washout period of at least 7 days."
166444|NCT01301742|P2|Participant Flow|Empa and Gemfibrozil First, Then Empa|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
166445|NCT01301742|P1|Participant Flow|Empa First, Then Empa and Gemfibrozil|Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
166446|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
166447|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
166448|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
166449|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
166450|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
166451|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
166452|NCT01301742|E3|Reported Event|Gemfibrozil Alone|Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
166453|NCT01301742|E2|Reported Event|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
166455|NCT01301729|B1|Baseline|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166456|NCT01301729|P1|Participant Flow|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166457|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166458|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166459|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166460|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166461|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166462|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166463|NCT01301729|O1|Outcome|Tastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166464|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166465|NCT01301729|E1|Reported Event|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
166466|NCT01301274|B3|Baseline|Total|Total of all reporting groups
166467|NCT01301274|B2|Baseline|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
166468|NCT01301274|B1|Baseline|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
166469|NCT01301274|P2|Participant Flow|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
166470|NCT01301274|P1|Participant Flow|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
166471|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
166472|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
166473|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
166474|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received fro maintenance solution ClNa 0.45% in Dx 5%
166475|NCT01301274|O2|Outcome|Isotonic Arm|patients who received maintenance solution 0.9% ClNa in Dx 5%
166476|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received maintenance solution 0.45% ClNa in Dx 5%
166477|NCT01301274|O2|Outcome|Isotonic Arm|Patients who received for maintenance solution 0.9% ClNa in Dx 5%
166478|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution 0.45% ClNa in Dx 5%
166479|NCT01301274|E2|Reported Event|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
166480|NCT01301274|E1|Reported Event|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
166481|NCT01301092|B4|Baseline|Total|Total of all reporting groups
166482|NCT01301092|B3|Baseline|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
188742|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
166483|NCT01301092|B2|Baseline|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
166484|NCT01301092|B1|Baseline|Part A: LY2189265 Intravenous|Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
166485|NCT01301092|P3|Participant Flow|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
166486|NCT01301092|P2|Participant Flow|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
166487|NCT01301092|P1|Participant Flow|Part A: LY2189265 Intravenous|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
166488|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
166489|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
166490|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
166491|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
166492|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
166493|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
166494|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
166495|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
166496|NCT01301092|E5|Reported Event|Part C: 0.75 mg SC LY2189265|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
166497|NCT01301092|E4|Reported Event|Part C: 0.75 mg IM LY2189265|Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
166498|NCT01301092|E3|Reported Event|Part B: 1.5 mg SC LY2189265|Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
166499|NCT01301092|E2|Reported Event|Part B: 0.1 mg IV LY2189265|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
166500|NCT01301092|E1|Reported Event|Part A: 0.1 mg IV LY2189265|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
166501|NCT01301079|B3|Baseline|Total|Total of all reporting groups
166502|NCT01301079|B2|Baseline|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution.~Saline : Patients in group N (placebo)will receive saline during surgery."
166503|NCT01301079|B1|Baseline|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery."
166504|NCT01301079|P2|Participant Flow|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166505|NCT01301079|P1|Participant Flow|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166506|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166507|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166603|NCT01301027|E1|Reported Event|Pioglitazone|"15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks~Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks"
166508|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166509|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166510|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166511|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166512|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166513|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166514|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166515|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166516|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166517|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166518|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166604|NCT01300819|B3|Baseline|Total|Total of all reporting groups
166662|NCT01300767|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
168000|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
166519|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166520|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166521|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166522|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166523|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166524|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166525|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166526|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166527|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166528|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166529|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166663|NCT01300741|B1|Baseline|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
166530|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166531|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166532|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166533|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166534|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166535|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166536|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166537|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166538|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166539|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166540|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166696|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166541|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166542|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166543|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166544|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166545|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166546|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166547|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166548|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166549|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166550|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166551|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
188743|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
166552|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166553|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166554|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166555|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166556|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166557|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166558|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166559|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166560|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166561|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166562|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
168001|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
166563|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166564|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166565|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
166566|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166567|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166568|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166569|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166570|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution.~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Saline: Patients in group N (placebo) was administrated saline during surgery."
166571|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery."
166572|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166605|NCT01300819|B2|Baseline|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
188744|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
166573|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166574|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166575|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166576|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166577|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166578|NCT01301079|E2|Reported Event|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166579|NCT01301079|E1|Reported Event|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
166580|NCT01301066|B3|Baseline|Total|Total of all reporting groups
166581|NCT01301066|B2|Baseline|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
166582|NCT01301066|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
166583|NCT01301066|P2|Participant Flow|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
166584|NCT01301066|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
166585|NCT01301066|O2|Outcome|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
166586|NCT01301066|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
166587|NCT01301066|E2|Reported Event|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
166588|NCT01301066|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
166589|NCT01301027|B3|Baseline|Total|Total of all reporting groups
166590|NCT01301027|B2|Baseline|Placebo|Placebo: 1 pill a day for 26 weeks
166591|NCT01301027|B1|Baseline|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166592|NCT01301027|P2|Participant Flow|Placebo|Placebo: 1 pill a day for 26 weeks
166593|NCT01301027|P1|Participant Flow|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166594|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
166595|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166596|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
166597|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166598|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
166599|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166600|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
166601|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
166602|NCT01301027|E2|Reported Event|Placebo|"1 placebo pill a day matching the pioglitazone treatment for 26 weeks~Placebo: 1 pill a day for 26 weeks"
166606|NCT01300819|B1|Baseline|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166607|NCT01300819|P2|Participant Flow|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166608|NCT01300819|P1|Participant Flow|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166609|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166610|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166611|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166612|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166613|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166614|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166615|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166616|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166617|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166618|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
168002|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
166619|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166620|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166621|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166622|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166623|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166624|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166625|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166626|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166627|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166628|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166629|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166630|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166631|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
168003|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
166632|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166633|NCT01300819|E2|Reported Event|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166634|NCT01300819|E1|Reported Event|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
166635|NCT01300767|B1|Baseline|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
166636|NCT01300767|P1|Participant Flow|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
166637|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166638|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166639|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166640|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166641|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166642|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166643|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166644|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166645|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166646|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166647|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166648|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166649|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166650|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166651|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166652|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166653|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166654|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166655|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166656|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166657|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166658|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166659|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166660|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
166661|NCT01300767|E2|Reported Event|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
167340|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
166664|NCT01300741|P1|Participant Flow|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
166665|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166666|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166667|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166668|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166669|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166670|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166671|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166672|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166673|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166674|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166675|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166676|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166677|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166678|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166679|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166680|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166681|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166682|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166683|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166684|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166685|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166686|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166687|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166688|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166689|NCT01300741|E2|Reported Event|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
166690|NCT01300741|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
166691|NCT01300728|B3|Baseline|Total|Total of all reporting groups
166692|NCT01300728|B2|Baseline|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166693|NCT01300728|B1|Baseline|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166694|NCT01300728|P2|Participant Flow|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166695|NCT01300728|P1|Participant Flow|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166697|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166698|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166699|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166700|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166701|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166702|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166703|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166704|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166705|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166706|NCT01300728|E2|Reported Event|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
166707|NCT01300728|E1|Reported Event|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
166708|NCT01300650|B1|Baseline|Anakinra|
166709|NCT01300650|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneous daily injection
166710|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous injection
166711|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
166712|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
166713|NCT01300650|E1|Reported Event|Anakinra|
166714|NCT01300624|B1|Baseline|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166715|NCT01300624|P1|Participant Flow|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166716|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.~Verb Network Strengthening Treatment: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke."
166717|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166718|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166719|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166720|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166721|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166722|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166723|NCT01300624|E1|Reported Event|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
166724|NCT01300559|B3|Baseline|Total|Total of all reporting groups
166725|NCT01300559|B2|Baseline|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
166726|NCT01300559|B1|Baseline|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
166727|NCT01300559|P2|Participant Flow|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
166728|NCT01300559|P1|Participant Flow|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
166729|NCT01300559|O2|Outcome|No Treatment Group|Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
166730|NCT01300559|O1|Outcome|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
166731|NCT01300559|E2|Reported Event|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
166732|NCT01300559|E1|Reported Event|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
166733|NCT01300546|B3|Baseline|Total|Total of all reporting groups
166734|NCT01300546|B2|Baseline|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166735|NCT01300546|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166736|NCT01300546|P2|Participant Flow|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166737|NCT01300546|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166738|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
168004|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
166739|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166740|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166741|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166742|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166743|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166744|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166745|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166746|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166747|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166748|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166749|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166750|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166751|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166752|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166753|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166754|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166755|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166756|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166757|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166758|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166759|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166760|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166761|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166762|NCT01300546|E2|Reported Event|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
166763|NCT01300546|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
166764|NCT01300455|B3|Baseline|Total|Total of all reporting groups
166765|NCT01300455|B2|Baseline|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
166766|NCT01300455|B1|Baseline|Suvorexant (40 mg) Then Placebo|In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
166767|NCT01300455|P2|Participant Flow|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
166768|NCT01300455|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
166769|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166770|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166771|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166772|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166773|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166774|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166775|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166776|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166777|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166778|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166779|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166780|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166781|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
166782|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166783|NCT01300455|E2|Reported Event|Placebo|Participants administered placebo.
166784|NCT01300455|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
166785|NCT01300351|B3|Baseline|Total|Total of all reporting groups
166786|NCT01300351|B2|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166787|NCT01300351|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166788|NCT01300351|P2|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166789|NCT01300351|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166790|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166791|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166792|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166793|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166794|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166795|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166796|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166797|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166798|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
166799|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166800|NCT01300351|E2|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
167341|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
166801|NCT01300351|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
166802|NCT01300338|B3|Baseline|Total|Total of all reporting groups
166803|NCT01300338|B2|Baseline|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
166804|NCT01300338|B1|Baseline|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
166805|NCT01300338|P2|Participant Flow|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry."
166806|NCT01300338|P1|Participant Flow|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
166807|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
166808|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
166809|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
166810|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
166811|NCT01300338|E2|Reported Event|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
166812|NCT01300338|E1|Reported Event|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
166813|NCT01300286|B1|Baseline|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
166814|NCT01300286|P1|Participant Flow|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
166815|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
166816|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
166817|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
166818|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
166819|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
166820|NCT01300286|E1|Reported Event|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
166821|NCT01300260|B3|Baseline|Total|Total of all reporting groups
166822|NCT01300260|B2|Baseline|Participants With Type 2 Diabetes Mellitus (T2DM)|Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
166823|NCT01300260|B1|Baseline|Healthy Participants|Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
166824|NCT01300260|P2|Participant Flow|Placebo First, Then LY2189265|"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
166825|NCT01300260|P1|Participant Flow|LY2189265 First, Then Placebo|"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
166826|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166908|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166827|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166828|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166829|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered
166830|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166831|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166832|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166833|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
166834|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166835|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166836|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166837|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166910|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166838|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166839|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166840|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166841|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166842|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166843|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes)
166844|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166845|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166846|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166847|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166848|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166849|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
166850|NCT01300260|E4|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
166851|NCT01300260|E3|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants who received at least 1 subcutaneous injection of Placebo
166852|NCT01300260|E2|Reported Event|Healthy Participants: LY2189265|Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
166853|NCT01300260|E1|Reported Event|Healthy Participants: Placebo|Healthy participants who received at least 1 subcutaneous injection of Placebo
166854|NCT01300247|B3|Baseline|Total|Total of all reporting groups
166855|NCT01300247|B2|Baseline|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166856|NCT01300247|B1|Baseline|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166857|NCT01300247|P2|Participant Flow|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166858|NCT01300247|P1|Participant Flow|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166859|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166860|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
167342|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
166861|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166862|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166863|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166864|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166865|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166866|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166867|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166868|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166869|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166870|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166871|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166872|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166873|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166874|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166875|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166876|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166877|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166878|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166909|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166879|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166880|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166881|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166882|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166883|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166884|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166885|NCT01300247|E2|Reported Event|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
166886|NCT01300247|E1|Reported Event|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
166887|NCT01300234|B3|Baseline|Total|Total of all reporting groups
166888|NCT01300234|B2|Baseline|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166889|NCT01300234|B1|Baseline|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166890|NCT01300234|P2|Participant Flow|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166891|NCT01300234|P1|Participant Flow|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166892|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166893|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166894|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166895|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166896|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166897|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166898|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166899|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166900|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166901|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166902|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166903|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166904|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166905|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166906|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166907|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166911|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166912|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166913|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166914|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166915|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166916|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166917|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166918|NCT01300234|E2|Reported Event|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
166919|NCT01300234|E1|Reported Event|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
166920|NCT01299961|B1|Baseline|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166921|NCT01299961|P1|Participant Flow|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166922|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166923|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166924|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166925|NCT01299961|E1|Reported Event|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
166926|NCT01299909|B4|Baseline|Total|Total of all reporting groups
166927|NCT01299909|B3|Baseline|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
166928|NCT01299909|B2|Baseline|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
166929|NCT01299909|B1|Baseline|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
166930|NCT01299909|P3|Participant Flow|Quitline|Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
166931|NCT01299909|P2|Participant Flow|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
166932|NCT01299909|P1|Participant Flow|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
166933|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
166934|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
166935|NCT01299909|E3|Reported Event|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
166936|NCT01299909|E2|Reported Event|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
166937|NCT01299909|E1|Reported Event|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
166938|NCT01299896|B3|Baseline|Total|Total of all reporting groups
166939|NCT01299896|B2|Baseline|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
166980|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166940|NCT01299896|B1|Baseline|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
166941|NCT01299896|P2|Participant Flow|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
166942|NCT01299896|P1|Participant Flow|Usual Care|"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
166943|NCT01299896|O2|Outcome|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
166944|NCT01299896|O1|Outcome|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
166945|NCT01299896|E2|Reported Event|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
166946|NCT01299896|E1|Reported Event|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
166947|NCT01299805|B3|Baseline|Total|Total of all reporting groups
166948|NCT01299805|B2|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166949|NCT01299805|B1|Baseline|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166950|NCT01299805|P2|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166951|NCT01299805|P1|Participant Flow|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166952|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166953|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166954|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166955|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166956|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166957|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166958|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166959|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166960|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166961|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166962|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166963|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166964|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166965|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166966|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166967|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166968|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166969|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166970|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166971|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166972|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166973|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166974|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166975|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166976|NCT01299805|E2|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
166977|NCT01299805|E1|Reported Event|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
166978|NCT01299584|B1|Baseline|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166979|NCT01299584|P1|Participant Flow|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166981|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166982|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166983|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166984|NCT01299584|E1|Reported Event|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
166985|NCT01299571|B1|Baseline|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
166986|NCT01299571|P1|Participant Flow|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
166987|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
166988|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
166989|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
166990|NCT01299571|E1|Reported Event|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
166991|NCT01299480|B6|Baseline|Total|Total of all reporting groups
166992|NCT01299480|B5|Baseline|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
166993|NCT01299480|B4|Baseline|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
166994|NCT01299480|B3|Baseline|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
166995|NCT01299480|B2|Baseline|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
166996|NCT01299480|B1|Baseline|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
166997|NCT01299480|P5|Participant Flow|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
166998|NCT01299480|P4|Participant Flow|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
166999|NCT01299480|P3|Participant Flow|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167000|NCT01299480|P2|Participant Flow|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167001|NCT01299480|P1|Participant Flow|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167002|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167003|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167004|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167005|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167006|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167007|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167008|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167009|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167010|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167011|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167012|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167013|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167014|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167015|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167016|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167017|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167018|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167019|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167020|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167021|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167022|NCT01299480|O1|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167023|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167024|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167025|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167026|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167027|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167028|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167029|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167030|NCT01299480|E5|Reported Event|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
167031|NCT01299480|E4|Reported Event|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
167032|NCT01299480|E3|Reported Event|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
167033|NCT01299480|E2|Reported Event|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
167034|NCT01299480|E1|Reported Event|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
167035|NCT01299454|B5|Baseline|Total|Total of all reporting groups
167036|NCT01299454|B4|Baseline|Normal Hepatic Function|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167037|NCT01299454|B3|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167038|NCT01299454|B2|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167039|NCT01299454|B1|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167040|NCT01299454|P4|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
167041|NCT01299454|P3|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
167042|NCT01299454|P2|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
167043|NCT01299454|P1|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
167044|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167045|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167046|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167047|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167048|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167049|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167050|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167051|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167052|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167053|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167054|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167055|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167056|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
168005|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167057|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167058|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167059|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167060|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167061|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167062|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167063|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167064|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167065|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167066|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167067|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167068|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167069|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167070|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167071|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167072|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167073|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
167074|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167075|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167076|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167077|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167078|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167079|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167080|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167081|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167082|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167083|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167084|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167085|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167086|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167087|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167088|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167089|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167090|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167091|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167092|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167093|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167094|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167095|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167096|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167097|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167098|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167099|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167100|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167101|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167102|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167103|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167104|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167105|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167106|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167107|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167108|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167109|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167110|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167111|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167112|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167113|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167114|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167115|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167116|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167117|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167118|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167119|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167120|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167121|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167122|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167123|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167124|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167125|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
188745|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
167126|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167127|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167128|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167129|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167130|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167131|NCT01299454|O5|Outcome|Sever Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167132|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167133|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167134|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167135|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167136|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167137|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167138|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167139|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167140|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167141|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167142|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167143|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167144|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167145|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167146|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167147|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167148|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167149|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167150|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167151|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167152|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participants with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Partipants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167153|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167154|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167155|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167156|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167157|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167158|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167159|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167160|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167161|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167162|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167163|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167164|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167165|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167166|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant ith hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167167|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167168|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167343|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167169|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167170|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participant with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167171|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167172|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a particpant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167173|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167174|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167175|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167176|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167177|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167178|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167179|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167180|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167181|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167182|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167183|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167184|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
167185|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167186|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167187|NCT01299454|O3|Outcome|Moderate Hepatic Impairment.|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167188|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167189|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
167190|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167191|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167192|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167193|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167194|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
167195|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167196|NCT01299454|E4|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167197|NCT01299454|E3|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167198|NCT01299454|E2|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167199|NCT01299454|E1|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
167200|NCT01299389|B3|Baseline|Total|Total of all reporting groups
167201|NCT01299389|B2|Baseline|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167202|NCT01299389|B1|Baseline|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167203|NCT01299389|P4|Participant Flow|Paliperidone Palmitate (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167204|NCT01299389|P3|Participant Flow|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167205|NCT01299389|P2|Participant Flow|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167206|NCT01299389|P1|Participant Flow|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
167207|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167208|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167209|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167210|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167211|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167212|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167213|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167214|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167215|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167216|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167217|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167218|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
167249|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167219|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167220|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
167221|NCT01299389|E4|Reported Event|Paliperidone Palmitate (Post-0bservational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167222|NCT01299389|E3|Reported Event|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
167223|NCT01299389|E2|Reported Event|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
167224|NCT01299389|E1|Reported Event|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
167225|NCT01299376|B3|Baseline|Total|Total of all reporting groups
167226|NCT01299376|B2|Baseline|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167227|NCT01299376|B1|Baseline|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167228|NCT01299376|P2|Participant Flow|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167229|NCT01299376|P1|Participant Flow|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167230|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167231|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167232|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167233|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167234|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167235|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167236|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167237|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167238|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167239|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167240|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167241|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
167242|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167243|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167244|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167245|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167246|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167247|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167248|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167250|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167251|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167252|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
167253|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
167254|NCT01299376|E4|Reported Event|L50/H12.5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
167255|NCT01299376|E3|Reported Event|L50/H12.5/A5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
167256|NCT01299376|E2|Reported Event|L50/H12.5/A5 - Double Blind Treatment Period|Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
167257|NCT01299376|E1|Reported Event|L50/H12.5- Double Blind Treatment Period|Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
167258|NCT01299103|B4|Baseline|Total|Total of all reporting groups
167259|NCT01299103|B3|Baseline|Triple Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
167260|NCT01299103|B2|Baseline|Double Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
167261|NCT01299103|B1|Baseline|Single Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
167262|NCT01299103|P3|Participant Flow|Triple Treatment|Subjects receive three treatments
167263|NCT01299103|P2|Participant Flow|Double Treatment|Subjects receive two treatments
167264|NCT01299103|P1|Participant Flow|Single Treatment|Subjects receive one treatment
167265|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
167266|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
167267|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
167268|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
167269|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
167270|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
167271|NCT01299103|E3|Reported Event|Triple Treatment|Subjects receive three treatments
167272|NCT01299103|E2|Reported Event|Double Treatment|Subjects receive two treatments
167273|NCT01299103|E1|Reported Event|Single Treatment|Subjects receive one treatment
167274|NCT01299090|B1|Baseline|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
167275|NCT01299090|P1|Participant Flow|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
167276|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
167277|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
167278|NCT01299090|E1|Reported Event|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
167279|NCT01299077|B1|Baseline|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167280|NCT01299077|P1|Participant Flow|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167281|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167282|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167283|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167284|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167285|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167336|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
188746|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
167286|NCT01299077|E1|Reported Event|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
167287|NCT01299025|B3|Baseline|Total|Total of all reporting groups
167288|NCT01299025|B2|Baseline|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167289|NCT01299025|B1|Baseline|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167290|NCT01299025|P2|Participant Flow|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167291|NCT01299025|P1|Participant Flow|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167292|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167293|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167294|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167295|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167296|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167297|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167298|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167299|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167300|NCT01299025|E2|Reported Event|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
167301|NCT01299025|E1|Reported Event|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
167302|NCT01298661|B4|Baseline|Total|Total of all reporting groups
167303|NCT01298661|B3|Baseline|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167304|NCT01298661|B2|Baseline|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167305|NCT01298661|B1|Baseline|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167306|NCT01298661|P3|Participant Flow|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167307|NCT01298661|P2|Participant Flow|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167308|NCT01298661|P1|Participant Flow|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167309|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167310|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167311|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167312|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167313|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167314|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167315|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167316|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167317|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167318|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167319|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167320|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167321|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167322|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167323|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167324|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167325|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167326|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167327|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167328|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167329|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167330|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167331|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167332|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167333|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167334|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167335|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167344|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167345|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167346|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167347|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167348|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167349|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167350|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167351|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167352|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167353|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167354|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167355|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167356|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167357|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167358|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167359|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167360|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167361|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167362|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167363|NCT01298661|O1|Outcome|COPD Patients|Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
167364|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167365|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167366|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167367|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167368|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167369|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167370|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167371|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167372|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167373|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167374|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167375|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167376|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167377|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167378|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167379|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167380|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167381|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167382|NCT01298661|E3|Reported Event|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
167383|NCT01298661|E2|Reported Event|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
167384|NCT01298661|E1|Reported Event|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
167385|NCT01298648|B1|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167386|NCT01298648|P1|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167387|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167388|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167389|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167390|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167391|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167392|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167393|NCT01298648|E1|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
167394|NCT01298544|B1|Baseline|Entire Study Population|All randomized participants
167395|NCT01298544|P1|Participant Flow|Entire Study Population|All randomized participants
167396|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
167430|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
188747|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
167397|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
167398|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
167399|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
167400|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
167401|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
167402|NCT01298544|E1|Reported Event|Entire Study Population|All randomized participants
167403|NCT01298531|B3|Baseline|Total|Total of all reporting groups
167404|NCT01298531|B2|Baseline|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167405|NCT01298531|B1|Baseline|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167406|NCT01298531|P2|Participant Flow|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167407|NCT01298531|P1|Participant Flow|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167408|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167409|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167410|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167411|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167412|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167413|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167414|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167415|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167416|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167417|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167418|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167419|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167420|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167421|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167422|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167423|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167424|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167425|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167426|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167427|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167428|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167429|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
168006|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167431|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167432|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167433|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167434|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167435|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167436|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167437|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167438|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167439|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167440|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167441|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167442|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167443|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167444|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167445|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167446|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167447|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167448|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167449|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167450|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167451|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167452|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167453|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167454|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167455|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167456|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167457|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167458|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167459|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167460|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167461|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167462|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167463|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167464|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167465|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167727|NCT01297517|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167466|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167467|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167468|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167469|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167470|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167471|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167472|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167473|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167474|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167475|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167476|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167477|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167478|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167479|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167480|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167481|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167482|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167483|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167484|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167485|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167486|NCT01298531|O1|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167487|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167488|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167489|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167490|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167491|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167492|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167493|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167494|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167495|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167496|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167497|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167498|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167499|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167500|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
168007|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167501|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167502|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167503|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167504|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167505|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167506|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167507|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167508|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167509|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167510|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167511|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167512|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167513|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167514|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167515|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167516|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167517|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167518|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167519|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167520|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167521|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167522|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167523|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167524|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167525|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167526|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167527|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167528|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167529|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167530|NCT01298531|E2|Reported Event|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
167531|NCT01298531|E1|Reported Event|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
167532|NCT01298518|B4|Baseline|Total|Total of all reporting groups
167533|NCT01298518|B3|Baseline|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167534|NCT01298518|B2|Baseline|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167535|NCT01298518|B1|Baseline|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167536|NCT01298518|P3|Participant Flow|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167537|NCT01298518|P2|Participant Flow|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167538|NCT01298518|P1|Participant Flow|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167539|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167540|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167541|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167542|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167543|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167544|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167545|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167546|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167547|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167548|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167549|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167550|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167551|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167552|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167553|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167554|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167555|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167556|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167557|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167558|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167559|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167560|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167561|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167562|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167563|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167564|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167565|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167566|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167567|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167568|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167569|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167570|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167571|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167572|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167573|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167574|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167575|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167576|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167577|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167578|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167579|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167580|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167581|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167582|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167583|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167584|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167585|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167586|NCT01298518|E3|Reported Event|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
167587|NCT01298518|E2|Reported Event|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
167588|NCT01298518|E1|Reported Event|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
167589|NCT01298362|B3|Baseline|Total|Total of all reporting groups
167590|NCT01298362|B2|Baseline|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167591|NCT01298362|B1|Baseline|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167592|NCT01298362|P2|Participant Flow|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167593|NCT01298362|P1|Participant Flow|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167594|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167595|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167596|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167597|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167598|NCT01298362|O2|Outcome|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167599|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167600|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167601|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167602|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167603|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167604|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167605|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167606|NCT01298362|O2|Outcome|HT Cohort|"In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.~BMD measurements in HT cohort were taken before AI start and at 12 months."
168008|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167607|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167608|NCT01298362|E2|Reported Event|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
167609|NCT01298362|E1|Reported Event|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
167610|NCT01298323|B3|Baseline|Total|Total of all reporting groups
167611|NCT01298323|B2|Baseline|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167612|NCT01298323|B1|Baseline|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167613|NCT01298323|P2|Participant Flow|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167614|NCT01298323|P1|Participant Flow|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167615|NCT01298323|O2|Outcome|Vandetanib 300 mg|Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
167616|NCT01298323|O1|Outcome|Vandetanib 300 mg+Outreach Program|Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
167617|NCT01298323|E2|Reported Event|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167618|NCT01298323|E1|Reported Event|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
167619|NCT01298167|B3|Baseline|Total|Total of all reporting groups
167620|NCT01298167|B2|Baseline|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
167621|NCT01298167|B1|Baseline|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
167622|NCT01298167|P2|Participant Flow|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
167623|NCT01298167|P1|Participant Flow|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
167624|NCT01298167|O2|Outcome|FAG Superior/Inferior|Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
167625|NCT01298167|O1|Outcome|Cyanoacrylate Superior/Inferior|Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.
167626|NCT01298167|E2|Reported Event|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
167627|NCT01298167|E1|Reported Event|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
167628|NCT01298128|B3|Baseline|Total|Total of all reporting groups
167629|NCT01298128|B2|Baseline|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
167630|NCT01298128|B1|Baseline|NuvaRing|NuvaRing for IVF pre-treatment
167631|NCT01298128|P2|Participant Flow|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
167632|NCT01298128|P1|Participant Flow|NuvaRing|NuvaRing for IVF pre-treatment
167633|NCT01298128|O2|Outcome|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
167634|NCT01298128|O1|Outcome|NuvaRing|NuvaRing for IVF pre-treatment
167635|NCT01298128|E2|Reported Event|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
167636|NCT01298128|E1|Reported Event|NuvaRing|NuvaRing for IVF pre-treatment
167637|NCT01298063|B6|Baseline|Total|Total of all reporting groups
167638|NCT01298063|B5|Baseline|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167639|NCT01298063|B4|Baseline|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167640|NCT01298063|B3|Baseline|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167641|NCT01298063|B2|Baseline|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167642|NCT01298063|B1|Baseline|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
167643|NCT01298063|P5|Participant Flow|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167644|NCT01298063|P4|Participant Flow|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167645|NCT01298063|P3|Participant Flow|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167646|NCT01298063|P2|Participant Flow|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167647|NCT01298063|P1|Participant Flow|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
188748|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
167648|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167649|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167650|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167651|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167652|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
167653|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167654|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167655|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167656|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167657|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
167658|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167659|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167660|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167661|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167662|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
167663|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167664|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167665|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167666|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167667|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
167668|NCT01298063|E5|Reported Event|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
167669|NCT01298063|E4|Reported Event|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
167670|NCT01298063|E3|Reported Event|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
167671|NCT01298063|E2|Reported Event|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
167672|NCT01298063|E1|Reported Event|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
167673|NCT01297920|B4|Baseline|Total|Total of all reporting groups
167674|NCT01297920|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
167675|NCT01297920|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
167676|NCT01297920|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
167677|NCT01297920|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
167678|NCT01297920|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
167679|NCT01297920|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
167680|NCT01297920|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
167681|NCT01297920|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
167682|NCT01297920|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
167683|NCT01297920|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
167684|NCT01297920|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
167685|NCT01297920|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
167686|NCT01297595|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
167726|NCT01297517|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167687|NCT01297595|P2|Participant Flow|Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
167688|NCT01297595|P1|Participant Flow|Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
167689|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167690|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167691|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167692|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167693|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167694|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167695|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167696|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167697|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167698|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167699|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167700|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167701|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167702|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167703|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167704|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167705|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167706|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167707|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167708|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167709|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167710|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167711|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167712|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167713|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167714|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167715|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167716|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167717|NCT01297595|E2|Reported Event|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
167718|NCT01297595|E1|Reported Event|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
167719|NCT01297517|B4|Baseline|Total|Total of all reporting groups
167720|NCT01297517|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167721|NCT01297517|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167722|NCT01297517|B1|Baseline|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167723|NCT01297517|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167724|NCT01297517|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167725|NCT01297517|P1|Participant Flow|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167728|NCT01297517|O1|Outcome|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167729|NCT01297517|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167730|NCT01297517|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167731|NCT01297517|E1|Reported Event|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
167732|NCT01297504|B1|Baseline|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167733|NCT01297504|P1|Participant Flow|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167734|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167735|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167736|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167737|NCT01297504|O2|Outcome|Multivariate|
167738|NCT01297504|O1|Outcome|Univariate|
167739|NCT01297504|O2|Outcome|LTRI Due to RSV|Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
167740|NCT01297504|O1|Outcome|LTRI|Hospitalizations due to lower respiratory tract infections (LRTI).
167741|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167742|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167743|NCT01297504|E1|Reported Event|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
167744|NCT01297491|B3|Baseline|Total|Total of all reporting groups
167745|NCT01297491|B2|Baseline|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167746|NCT01297491|B1|Baseline|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167747|NCT01297491|P2|Participant Flow|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167748|NCT01297491|P1|Participant Flow|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167749|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167750|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167751|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167752|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167753|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167754|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167755|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167756|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167757|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167758|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167759|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167760|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167761|NCT01297491|E2|Reported Event|Non-Squamous BKM120 100 mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
167762|NCT01297491|E1|Reported Event|Squamous BKM120 100 mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
167763|NCT01297465|B3|Baseline|Total|Total of all reporting groups
167764|NCT01297465|B2|Baseline|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
188749|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
167765|NCT01297465|B1|Baseline|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167766|NCT01297465|P2|Participant Flow|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167767|NCT01297465|P1|Participant Flow|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167768|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167769|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167770|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167771|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167772|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167773|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167774|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167775|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167776|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167807|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
167808|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
168009|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167777|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167778|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167779|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167780|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167781|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167782|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167783|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167784|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167785|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167786|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167787|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167788|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167809|NCT01297348|E2|Reported Event|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
167810|NCT01297348|E1|Reported Event|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
168010|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167789|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167790|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167791|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167792|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167793|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167794|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167795|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167796|NCT01297465|E2|Reported Event|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
167797|NCT01297465|E1|Reported Event|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
167798|NCT01297348|B3|Baseline|Total|Total of all reporting groups
167799|NCT01297348|B2|Baseline|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
167800|NCT01297348|B1|Baseline|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
167801|NCT01297348|P2|Participant Flow|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
167802|NCT01297348|P1|Participant Flow|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
167803|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
167804|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
167805|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
167806|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
167811|NCT01297335|B1|Baseline|Intrathecal Clonidine|All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
167812|NCT01297335|P1|Participant Flow|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
167813|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
167814|NCT01297335|O1|Outcome|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
167815|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
167816|NCT01297335|E1|Reported Event|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
167817|NCT01297322|B3|Baseline|Total|Total of all reporting groups
167818|NCT01297322|B2|Baseline|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167819|NCT01297322|B1|Baseline|Manual Compression|Manual compression: Standard of Care
167820|NCT01297322|P2|Participant Flow|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167821|NCT01297322|P1|Participant Flow|Manual Compression|Manual compression: Standard of Care
167822|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167823|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167824|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167825|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167826|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167827|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167828|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167829|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167830|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167831|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167832|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167833|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167834|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167835|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167836|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167837|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
167838|NCT01297322|E2|Reported Event|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
167839|NCT01297322|E1|Reported Event|Manual Compression|Manual compression: Standard of Care
167840|NCT01297283|B1|Baseline|Overall Subjects|
167841|NCT01297283|P1|Participant Flow|Overall Subjects|Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
167842|NCT01297283|O1|Outcome|Overall Subjects|
167843|NCT01297283|O1|Outcome|Overall Subjects|
167844|NCT01297283|E1|Reported Event|Overall Subjects|
167845|NCT01297270|B4|Baseline|Total|Total of all reporting groups
167846|NCT01297270|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167847|NCT01297270|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167848|NCT01297270|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167849|NCT01297270|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
188750|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
167850|NCT01297270|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167851|NCT01297270|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167852|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167853|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167854|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167855|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167856|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167857|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167858|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167859|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167860|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167861|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167862|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167863|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167864|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167865|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167866|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167867|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167868|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167869|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167870|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167871|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167872|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167873|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
168011|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167874|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167875|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167876|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167877|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167878|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167879|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167880|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167881|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167882|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167883|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167884|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167885|NCT01297270|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
167886|NCT01297270|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167887|NCT01297270|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
167888|NCT01297257|B1|Baseline|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
167889|NCT01297257|P1|Participant Flow|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
167890|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
167891|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
167892|NCT01297257|E1|Reported Event|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
167893|NCT01297062|B7|Baseline|Total|Total of all reporting groups
167894|NCT01297062|B6|Baseline|Exenatide-Placebo-Moxifloxacin Sequence|Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
167895|NCT01297062|B5|Baseline|Placebo-Moxifloxacin-Exenatiden Sequence|Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
167896|NCT01297062|B4|Baseline|Moxifloxacin-Exenatide-Placebo Sequence|Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
167897|NCT01297062|B3|Baseline|Moxifloxacin-Placebo-Exenatide Sequence|Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
167898|NCT01297062|B2|Baseline|Exenatide-Moxifloxacin-Placebo Sequence|Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
167899|NCT01297062|B1|Baseline|Placebo-Exenatide-Moxifloxacin Sequence|Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III
167900|NCT01297062|P7|Participant Flow|Non-Randomized|Not Randomized
167942|NCT01296815|B1|Baseline|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
167943|NCT01296815|P2|Participant Flow|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
168012|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167901|NCT01297062|P6|Participant Flow|Exenatide-Placebo-Moxifloxacin Sequence|"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167902|NCT01297062|P5|Participant Flow|Placebo-Moxifloxacin-Exenatiden Sequence|"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167903|NCT01297062|P4|Participant Flow|Moxifloxacin-Exenatide-Placebo Sequence|"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167904|NCT01297062|P3|Participant Flow|Moxifloxacin-Placebo-Exenatide Sequence|"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167905|NCT01297062|P2|Participant Flow|Exenatide-Moxifloxacin-Placebo Sequence|"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167906|NCT01297062|P1|Participant Flow|Placebo-Exenatide-Moxifloxacin Sequence|"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
167907|NCT01297062|O1|Outcome|Exenatide|Exenatide
167908|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167909|NCT01297062|O1|Outcome|Exenatide|Exenatide
167910|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167911|NCT01297062|O1|Outcome|Exenatide|Exenatide
167912|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167913|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
167914|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167915|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
167916|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167917|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
167918|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167919|NCT01297062|O1|Outcome|Exenatide|Exenatide
167920|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167921|NCT01297062|O1|Outcome|Exenatide|Exenatide
167922|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
167923|NCT01297062|O1|Outcome|Exenatide|Exenatide
167924|NCT01297062|E3|Reported Event|Moxifloxacin|Moxifloxacin with placebo infusion
167925|NCT01297062|E2|Reported Event|Placebo|Placebo Comparator
167926|NCT01297062|E1|Reported Event|Exenatide|Exenatide
167927|NCT01296841|B3|Baseline|Total|Total of all reporting groups
167928|NCT01296841|B2|Baseline|Telemedicine Encounter|Remote clinical appointment between patient and physician.
167929|NCT01296841|B1|Baseline|Standard Encounter|"Standard in-house clinical visit between patient and physician."
167930|NCT01296841|P2|Participant Flow|Telemedicine Encounter|Remote clinical appointment between patient and physician.
167931|NCT01296841|P1|Participant Flow|Standard Encounter|"Standard in-house clinical visit between patient and physician."
167932|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
167933|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
167934|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
167935|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
167936|NCT01296841|O2|Outcome|Standard|clinic experience (mean±SD)
167937|NCT01296841|O1|Outcome|Telemedicine|clinic experience (mean ± SD, 1 excellent, 5 poor)
167938|NCT01296841|E2|Reported Event|Telemedicine Encounter|Remote clinical appointment between patient and physician.
167939|NCT01296841|E1|Reported Event|Standard Encounter|"Standard in-house clinical visit between patient and physician."
167940|NCT01296815|B3|Baseline|Total|Total of all reporting groups
167941|NCT01296815|B2|Baseline|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
167944|NCT01296815|P1|Participant Flow|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
167945|NCT01296815|O2|Outcome|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
167946|NCT01296815|O1|Outcome|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
167947|NCT01296815|E2|Reported Event|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
167948|NCT01296815|E1|Reported Event|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
167949|NCT01296763|B4|Baseline|Total|Total of all reporting groups
167950|NCT01296763|B3|Baseline|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
167951|NCT01296763|B2|Baseline|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
167952|NCT01296763|B1|Baseline|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
167953|NCT01296763|P3|Participant Flow|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
167954|NCT01296763|P2|Participant Flow|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
167955|NCT01296763|P1|Participant Flow|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
167956|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
167957|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
167958|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
167959|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
167960|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
167961|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
167962|NCT01296763|E3|Reported Event|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
167963|NCT01296763|E2|Reported Event|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
167964|NCT01296763|E1|Reported Event|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
167965|NCT01296698|B3|Baseline|Total|Total of all reporting groups
167966|NCT01296698|B2|Baseline|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167967|NCT01296698|B1|Baseline|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167968|NCT01296698|P2|Participant Flow|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167969|NCT01296698|P1|Participant Flow|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167970|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167971|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167972|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167973|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167974|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167975|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167976|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167977|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167978|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167979|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167980|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167981|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167982|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167983|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167984|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167985|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167986|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167987|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167988|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167989|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167990|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167991|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167992|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167993|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167994|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167995|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167996|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167997|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
167998|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
167999|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
168013|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
168014|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
168015|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
168016|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
168017|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
168018|NCT01296698|E2|Reported Event|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
168019|NCT01296698|E1|Reported Event|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
168020|NCT01296646|B3|Baseline|Total|Total of all reporting groups
168021|NCT01296646|B2|Baseline|Naltrexone|50 mg of naltrexone orally daily.
168022|NCT01296646|B1|Baseline|Placebo|Placebo taken once daily.
168023|NCT01296646|P2|Participant Flow|Naltrexone|50 mg of naltrexone orally daily.
168024|NCT01296646|P1|Participant Flow|Placebo|Placebo taken once daily.
168025|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
168026|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
168027|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
168028|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
168029|NCT01296646|E2|Reported Event|Naltrexone|50 mg of naltrexone orally daily.
168030|NCT01296646|E1|Reported Event|Placebo|Placebo taken once daily.
168031|NCT01296412|B3|Baseline|Total|Total of all reporting groups
168032|NCT01296412|B2|Baseline|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168033|NCT01296412|B1|Baseline|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168034|NCT01296412|P2|Participant Flow|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168035|NCT01296412|P1|Participant Flow|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168036|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168037|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168038|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168039|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168040|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168041|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168042|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168043|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168044|NCT01296412|E2|Reported Event|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
168045|NCT01296412|E1|Reported Event|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
168046|NCT01296360|B3|Baseline|Total|Total of all reporting groups
168047|NCT01296360|B2|Baseline|Non-Booster Group|No treatment in study IC51-325
168048|NCT01296360|B1|Baseline|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
168049|NCT01296360|P2|Participant Flow|Non-Booster Group|No treatment in study IC51-325
168050|NCT01296360|P1|Participant Flow|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
168051|NCT01296360|O2|Outcome|>3 Years - <18 Years|booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
168052|NCT01296360|O1|Outcome|>14 Months to <2 Years|booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
168053|NCT01296360|E2|Reported Event|Non-Booster Group|No treatment in study IC51-325
168054|NCT01296360|E1|Reported Event|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
168089|NCT01295905|B1|Baseline|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168055|NCT01296152|B1|Baseline|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
168056|NCT01296152|P1|Participant Flow|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
168057|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168058|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168059|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168060|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168061|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168062|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168063|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168064|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168065|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168066|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168067|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168068|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168069|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168070|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168071|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168072|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168073|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168074|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168075|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168076|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168077|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168078|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168079|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168080|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168081|NCT01296152|E1|Reported Event|Arm A|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
168082|NCT01296035|B1|Baseline|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
168083|NCT01296035|P1|Participant Flow|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
168084|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
168085|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
168086|NCT01296035|E1|Reported Event|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
168087|NCT01295905|B3|Baseline|Total|Total of all reporting groups
168088|NCT01295905|B2|Baseline|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168090|NCT01295905|P2|Participant Flow|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168091|NCT01295905|P1|Participant Flow|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168092|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168093|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168094|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168095|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168096|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168097|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168098|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168099|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168100|NCT01295905|E2|Reported Event|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168101|NCT01295905|E1|Reported Event|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
168102|NCT01295879|B1|Baseline|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168103|NCT01295879|P1|Participant Flow|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168104|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168105|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168106|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168107|NCT01295879|E1|Reported Event|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
168108|NCT01295840|B1|Baseline|No Arms|All patient have a Quartet LV lead. No arms.
168109|NCT01295840|P1|Participant Flow|No Arms|All patient have a Quartet Left Ventricular (LV) lead. No arms.
168110|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168111|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168112|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168113|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168114|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168115|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168116|NCT01295840|O1|Outcome|Quartet LV Lead|All patient have a Quartet LV lead. No arms
168117|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168118|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168119|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
168120|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms.
168121|NCT01295840|E1|Reported Event|No Arms|All patient have a Quartet LV lead. No arms
168122|NCT01295814|B3|Baseline|Total|Total of all reporting groups
168123|NCT01295814|B2|Baseline|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168124|NCT01295814|B1|Baseline|Inactive Drug|inactive drug : placebo
168125|NCT01295814|P2|Participant Flow|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168126|NCT01295814|P1|Participant Flow|Inactive Drug|inactive drug : placebo
168127|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168128|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
168129|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168130|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
168131|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168132|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
168133|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168134|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
168135|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168136|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
168137|NCT01295814|E2|Reported Event|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
168138|NCT01295814|E1|Reported Event|Inactive Drug|inactive drug : placebo
168139|NCT01295281|B3|Baseline|Total|Total of all reporting groups
168140|NCT01295281|B2|Baseline|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
168174|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168220|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168141|NCT01295281|B1|Baseline|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
168142|NCT01295281|P2|Participant Flow|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
168143|NCT01295281|P1|Participant Flow|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
168144|NCT01295281|O2|Outcome|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
168145|NCT01295281|O1|Outcome|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
168146|NCT01295281|E2|Reported Event|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
168147|NCT01295281|E1|Reported Event|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
168148|NCT01294917|B1|Baseline|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
168149|NCT01294917|P1|Participant Flow|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
168150|NCT01294917|O3|Outcome|OptiFree RepleniSH MPS|All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
168151|NCT01294917|O2|Outcome|Clear Care|All subjects received the Clear Care for one month for the care of their soft contact lenses.
168152|NCT01294917|O1|Outcome|AMO Investigational MPS|All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.
168153|NCT01294917|E1|Reported Event|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
168154|NCT01294800|B5|Baseline|Total|Total of all reporting groups
168155|NCT01294800|B4|Baseline|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168156|NCT01294800|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168157|NCT01294800|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168158|NCT01294800|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
168159|NCT01294800|P4|Participant Flow|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168160|NCT01294800|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168161|NCT01294800|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168162|NCT01294800|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
168163|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168164|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168165|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168166|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168167|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168168|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168169|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168170|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168171|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168172|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168173|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168471|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168175|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168176|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168177|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168178|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168179|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168180|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168181|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168182|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168183|NCT01294800|E4|Reported Event|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168184|NCT01294800|E3|Reported Event|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168185|NCT01294800|E2|Reported Event|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168186|NCT01294800|E1|Reported Event|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
168187|NCT01294787|B1|Baseline|All Participants|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.
168188|NCT01294787|P6|Participant Flow|Tiotropium / Placebo / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168189|NCT01294787|P5|Participant Flow|Tiotropium / QAV149 / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168190|NCT01294787|P4|Participant Flow|Placebo / Tiotropium / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168191|NCT01294787|P3|Participant Flow|Placebo / QVA149 / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168192|NCT01294787|P2|Participant Flow|QVA149 / Tiotropium / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168193|NCT01294787|P1|Participant Flow|QVA149 / Placebo / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
168194|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168195|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168196|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168197|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168198|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
168199|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
168200|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168201|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168202|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
168203|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168204|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168205|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
168206|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168207|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
168208|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168209|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168210|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168211|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168212|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168213|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168214|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168215|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168216|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168217|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168218|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168219|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168221|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168222|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168223|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168224|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168225|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168226|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
168227|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168228|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168229|NCT01294787|O2|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
168230|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
168231|NCT01294787|E3|Reported Event|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
168232|NCT01294787|E2|Reported Event|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
168233|NCT01294787|E1|Reported Event|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
168234|NCT01294748|B3|Baseline|Total|Total of all reporting groups
168235|NCT01294748|B2|Baseline|Endeavor DES|Active Comparator: Endeavor DES
168236|NCT01294748|B1|Baseline|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168237|NCT01294748|P2|Participant Flow|Endeavor DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168238|NCT01294748|P1|Participant Flow|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168239|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168240|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168241|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168242|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168243|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168244|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168245|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168246|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168247|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168248|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168249|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168250|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168251|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168252|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168253|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168254|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168255|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168256|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168257|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168258|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168259|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
168260|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168261|NCT01294748|E2|Reported Event|Endeavor DES|Active Comparator: Endeavor DES
168262|NCT01294748|E1|Reported Event|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
168263|NCT01294709|B1|Baseline|All Enrolled Participants|All enrolled participants who recieved at least one dose of either telcagepant or placebo.
168264|NCT01294709|P2|Participant Flow|Placebo Then Telcagepant|Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
168265|NCT01294709|P1|Participant Flow|Telcagepant Then Placebo|Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
168548|NCT01294306|B2|Baseline|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168266|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
168267|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
168268|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
168269|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
168270|NCT01294709|O2|Outcome|Placebo|Participants who received single oral dose of placebo in Period 1 or 2 of crossover
168271|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
168272|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
168273|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
168274|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
168275|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
168276|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
168277|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
168278|NCT01294709|E3|Reported Event|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
168279|NCT01294709|E2|Reported Event|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
168280|NCT01294709|E1|Reported Event|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
168281|NCT01294696|B3|Baseline|Total|Total of all reporting groups
168282|NCT01294696|B2|Baseline|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
168283|NCT01294696|B1|Baseline|Participants With Adequate Pain Relief|Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
168284|NCT01294696|P1|Participant Flow|All Enrolled Participants|The population consisted of all enrolled participants with adequate and inadequate pain relief.
168285|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168286|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168287|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168288|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168289|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168290|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168291|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168292|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
168293|NCT01294696|E2|Reported Event|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
168294|NCT01294696|E1|Reported Event|Participants With Adequate Pain Relief|Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI).
168295|NCT01294683|B3|Baseline|Total|Total of all reporting groups
168296|NCT01294683|B2|Baseline|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
168297|NCT01294683|B1|Baseline|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
168298|NCT01294683|P2|Participant Flow|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
168299|NCT01294683|P1|Participant Flow|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
168300|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168301|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168549|NCT01294306|B1|Baseline|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168302|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168303|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168304|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168305|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168306|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168307|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168308|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168309|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168310|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168311|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168312|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168313|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168314|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168315|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168316|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168317|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168318|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168319|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168320|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168321|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168322|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168323|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168324|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168325|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168326|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168327|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168328|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168329|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168330|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168331|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168332|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168333|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168334|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168335|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168336|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168337|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
168338|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
168339|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168340|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
168341|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
168342|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
168343|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
168344|NCT01294683|E4|Reported Event|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
168345|NCT01294683|E3|Reported Event|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III
168550|NCT01294306|P2|Participant Flow|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168346|NCT01294683|E2|Reported Event|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
168347|NCT01294683|E1|Reported Event|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
168348|NCT01294644|B4|Baseline|Total|Total of all reporting groups
168349|NCT01294644|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168350|NCT01294644|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168351|NCT01294644|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168352|NCT01294644|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168353|NCT01294644|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168354|NCT01294644|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168355|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168356|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168357|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168358|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168359|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168360|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168361|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168362|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168363|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168364|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168365|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168366|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168367|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168368|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168369|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168370|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168371|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168372|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168373|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168374|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168375|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168472|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168376|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168377|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168378|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168379|NCT01294644|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168380|NCT01294644|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
168381|NCT01294644|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
168382|NCT01294592|B3|Baseline|Total|Total of all reporting groups
168383|NCT01294592|B2|Baseline|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168384|NCT01294592|B1|Baseline|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168385|NCT01294592|P2|Participant Flow|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168386|NCT01294592|P1|Participant Flow|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168387|NCT01294592|O3|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
168388|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168389|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168390|NCT01294592|O2|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
168391|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168392|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168393|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168394|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168395|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168396|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168397|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168473|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168474|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168398|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168399|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168400|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168401|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168402|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168403|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168404|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168405|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168406|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168407|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168408|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
168409|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168410|NCT01294592|E3|Reported Event|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
168411|NCT01294592|E2|Reported Event|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
168412|NCT01294592|E1|Reported Event|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
168413|NCT01294553|B1|Baseline|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
168414|NCT01294553|P1|Participant Flow|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention.
168415|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
168416|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
168475|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168476|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168417|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
168418|NCT01294553|E1|Reported Event|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
168419|NCT01294514|B1|Baseline|Healthy Volunteers|Healthy volunteers were studied
168420|NCT01294514|P1|Participant Flow|Respiration Rate in Healthy Volunteers|"Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors.~Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide."
168421|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
168422|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
168423|NCT01294514|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate determined by Transthoracic Impedance
168424|NCT01294514|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide|Respiration Rate determined by manual overscoring of capnography waveforms.
168425|NCT01294514|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration Rate determined by novel plethysmographic analysis
168426|NCT01294514|E1|Reported Event|Healthy Volunteers|A selection of subjects from the general population from ages 18 - 50.
168427|NCT01294462|B3|Baseline|Total|Total of all reporting groups
168428|NCT01294462|B2|Baseline|Clopidogrel|Clopidogrel 75mg od
168429|NCT01294462|B1|Baseline|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
168430|NCT01294462|P2|Participant Flow|Clopidogrel|Clopidogrel 75mg od
168431|NCT01294462|P1|Participant Flow|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
168432|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
168433|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
168434|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
168435|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
168436|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
168437|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
168438|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
168439|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
168440|NCT01294462|E2|Reported Event|Clopidogrel|Clopidogrel 75mg od
168441|NCT01294462|E1|Reported Event|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
168442|NCT01294449|B3|Baseline|Total|Total of all reporting groups
168443|NCT01294449|B2|Baseline|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
168444|NCT01294449|B1|Baseline|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
168445|NCT01294449|P2|Participant Flow|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
168446|NCT01294449|P1|Participant Flow|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
168447|NCT01294449|O2|Outcome|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
168448|NCT01294449|O1|Outcome|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
168449|NCT01294449|E2|Reported Event|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
168450|NCT01294449|E1|Reported Event|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
168451|NCT01294436|B3|Baseline|Total|Total of all reporting groups
168452|NCT01294436|B2|Baseline|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168453|NCT01294436|B1|Baseline|Monotherapy|Dapagliflozin 5/10 mg only
168454|NCT01294436|P2|Participant Flow|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168455|NCT01294436|P1|Participant Flow|Monotherapy|Dapagliflozin 5/10 mg only
168456|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168457|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168458|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168459|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168460|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168461|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168462|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168463|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168464|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168465|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168466|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168467|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168468|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168469|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168470|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168478|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168479|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168480|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168481|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168482|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168483|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
168484|NCT01294436|E2|Reported Event|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
168485|NCT01294436|E1|Reported Event|Monotherapy|Dapagliflozin 5/10 mg only
168486|NCT01294423|B4|Baseline|Total|Total of all reporting groups
168487|NCT01294423|B3|Baseline|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168488|NCT01294423|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168489|NCT01294423|B1|Baseline|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168490|NCT01294423|P3|Participant Flow|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168491|NCT01294423|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168492|NCT01294423|P1|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168493|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168494|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168495|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168496|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168497|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168498|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168499|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168500|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168501|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168502|NCT01294423|E3|Reported Event|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
168503|NCT01294423|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
168504|NCT01294423|E1|Reported Event|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
168505|NCT01294384|B4|Baseline|Total|Total of all reporting groups
168506|NCT01294384|B3|Baseline|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168507|NCT01294384|B2|Baseline|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168508|NCT01294384|B1|Baseline|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168509|NCT01294384|P3|Participant Flow|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168510|NCT01294384|P2|Participant Flow|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168511|NCT01294384|P1|Participant Flow|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168512|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168513|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168514|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168515|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168516|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168517|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168518|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168519|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168520|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168521|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168522|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168523|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168524|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168551|NCT01294306|P1|Participant Flow|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168525|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168526|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168527|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168528|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168529|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168530|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168531|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168532|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168533|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168534|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168535|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168536|NCT01294384|E3|Reported Event|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
168537|NCT01294384|E2|Reported Event|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
168538|NCT01294384|E1|Reported Event|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
168539|NCT01294371|B1|Baseline|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
168540|NCT01294371|P1|Participant Flow|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
168541|NCT01294371|O3|Outcome|No Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
168542|NCT01294371|O2|Outcome|Plus Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.
168543|NCT01294371|O1|Outcome|Overall|"Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was impossible — phytoestrogens with calcium products."
168544|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
168545|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
168546|NCT01294371|E1|Reported Event|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
168552|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168553|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168554|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168555|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168556|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168557|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168558|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168559|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168560|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168561|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168562|NCT01294306|E2|Reported Event|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
168563|NCT01294306|E1|Reported Event|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
168564|NCT01294228|B1|Baseline|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
168565|NCT01294228|P1|Participant Flow|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
168566|NCT01294228|O1|Outcome|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
168567|NCT01294228|E1|Reported Event|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
168568|NCT01294163|B4|Baseline|Total|Total of all reporting groups
168569|NCT01294163|B3|Baseline|TIVA|Anesthetic agent before and after CPB: propofol
168570|NCT01294163|B2|Baseline|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
168571|NCT01294163|B1|Baseline|Xenon|Anesthetic agent before and after CPB: xenon
168572|NCT01294163|P3|Participant Flow|TIVA|Anesthetic agent before and after CPB: propofol
168573|NCT01294163|P2|Participant Flow|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
168574|NCT01294163|P1|Participant Flow|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
168575|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
168576|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
168577|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
168578|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
168579|NCT01294163|E3|Reported Event|TIVA|Anesthetic agent before and after CPB: propofol
168580|NCT01294163|E2|Reported Event|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
168581|NCT01294163|E1|Reported Event|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
168582|NCT01294150|B3|Baseline|Total|Total of all reporting groups
168583|NCT01294150|B2|Baseline|Cystoscopy|Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.
168584|NCT01294150|B1|Baseline|UroLift System|Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.
168585|NCT01294150|P2|Participant Flow|Cystoscopy (Control/Sham)|The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
168586|NCT01294150|P1|Participant Flow|UroLift System|The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.
168587|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
168588|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
168589|NCT01294150|O2|Outcome|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
168590|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
168591|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
168592|NCT01294150|E2|Reported Event|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
168593|NCT01294150|E1|Reported Event|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
168594|NCT01293968|B3|Baseline|Total|Total of all reporting groups
168595|NCT01293968|B2|Baseline|Diphenhydramine and Aluminium MgS|
168596|NCT01293968|B1|Baseline|Ibuprofen, Diphenhydramine and Aluminium MgS|
168597|NCT01293968|P2|Participant Flow|Diphenhydramine and Aluminium MgS|
168598|NCT01293968|P1|Participant Flow|Ibuprofen, Diphenhydramine and Aluminium MgS|
168599|NCT01293968|O2|Outcome|Diphenhydramine and Aluminium MgS|the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
168600|NCT01293968|O1|Outcome|Ibuprofen, Diphenhydramine and Aluminium MgS|the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
168601|NCT01293968|E2|Reported Event|Diphenhydramine and Aluminium MgS|
168602|NCT01293968|E1|Reported Event|Ibuprofen, Diphenhydramine and Aluminium MgS|
168603|NCT01293825|B1|Baseline|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168604|NCT01293825|P1|Participant Flow|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168605|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168606|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168607|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168608|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168609|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168610|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168611|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168612|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168613|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168614|NCT01293825|E1|Reported Event|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
168615|NCT01293695|B3|Baseline|Total|Total of all reporting groups
168616|NCT01293695|B2|Baseline|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168617|NCT01293695|B1|Baseline|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy (HRT)~Hypnosis: Hypnosis relaxation in five weekly sessions"
168618|NCT01293695|P2|Participant Flow|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168619|NCT01293695|P1|Participant Flow|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
168620|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168621|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
168622|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168623|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
168826|NCT01292473|P2|Participant Flow|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
168827|NCT01292473|P1|Participant Flow|Placebo|Placebo subcutaneously (sc) every 4 weeks.
168624|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168625|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
168626|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168627|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
168628|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168629|NCT01293695|O1|Outcome|Hypnosis|"Received 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
168630|NCT01293695|E2|Reported Event|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
168631|NCT01293695|E1|Reported Event|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
168632|NCT01293240|B1|Baseline|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168633|NCT01293240|P1|Participant Flow|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168634|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168635|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168636|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168637|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168638|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168639|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168640|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168641|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168642|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168643|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168644|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168645|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168646|NCT01293240|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
168647|NCT01293084|B1|Baseline|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
168648|NCT01293084|P1|Participant Flow|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
168649|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
168650|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
168651|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
168652|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
168653|NCT01293084|E2|Reported Event|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
168654|NCT01293084|E1|Reported Event|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
168655|NCT01293032|B5|Baseline|Total|Total of all reporting groups
168656|NCT01293032|B4|Baseline|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168828|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168829|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168830|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168657|NCT01293032|B3|Baseline|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168658|NCT01293032|B2|Baseline|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168659|NCT01293032|B1|Baseline|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168660|NCT01293032|P4|Participant Flow|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168661|NCT01293032|P3|Participant Flow|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168662|NCT01293032|P2|Participant Flow|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168663|NCT01293032|P1|Participant Flow|Group 1 (RS < 11)|"Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168664|NCT01293032|O1|Outcome|Group 2 (RS 11-25)|Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
168665|NCT01293032|E4|Reported Event|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168666|NCT01293032|E3|Reported Event|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
168667|NCT01293032|E2|Reported Event|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168668|NCT01293032|E1|Reported Event|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
168669|NCT01293006|B5|Baseline|Total|Total of all reporting groups
168670|NCT01293006|B4|Baseline|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
168671|NCT01293006|B3|Baseline|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
168672|NCT01293006|B2|Baseline|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of MK-suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
168831|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168832|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168673|NCT01293006|B1|Baseline|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of, at least, 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
168674|NCT01293006|P4|Participant Flow|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
168675|NCT01293006|P3|Participant Flow|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
168676|NCT01293006|P2|Participant Flow|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
168677|NCT01293006|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
168678|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
168679|NCT01293006|O1|Outcome|Suvorexant (40 mg or 30 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
168680|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
168681|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
168682|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
168683|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or 30-mg dose of suvorexant.
168684|NCT01293006|O2|Outcome|Placebo|Participants receiving placebo.
168685|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants receiving either a 40-mg or 30-mg dose of suvorexant.
168686|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
168687|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
168688|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
168689|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
168690|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
168691|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
168692|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
168693|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg oral dose of suvorexant.
168694|NCT01293006|E3|Reported Event|Placebo|Participants administered placebo.
168695|NCT01293006|E2|Reported Event|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
168696|NCT01293006|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
168697|NCT01292928|B1|Baseline|Innova Stent|Stent implantation into SFA/PPA
168698|NCT01292928|P1|Participant Flow|Innova Stent|Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
168699|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168700|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168701|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168702|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168703|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168704|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168705|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168706|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168707|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168708|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168709|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168710|NCT01292928|O2|Outcome|Innova Stent Entire Matrix (20-200 mm)|Entire Matrix Stent implantation into SFA/PPA
168711|NCT01292928|O1|Outcome|Innova Stent Core Matrix (20-150 mm)|Core Matrix Stent implantation into SFA/PPA
168712|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
168713|NCT01292928|E1|Reported Event|Innova Stent|Stent implantation into SFA/PPA
168714|NCT01292837|B1|Baseline|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168715|NCT01292837|P1|Participant Flow|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168716|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168717|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168833|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168718|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168719|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168720|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168721|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168722|NCT01292837|E1|Reported Event|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
168723|NCT01292798|B1|Baseline|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
168724|NCT01292798|P1|Participant Flow|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
168725|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
168726|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
168727|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
168728|NCT01292798|E1|Reported Event|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
168729|NCT01292746|B1|Baseline|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
168730|NCT01292746|P1|Participant Flow|Erchonia MLS|Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
168731|NCT01292746|O1|Outcome|Erchonia MLS|Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
168732|NCT01292746|E1|Reported Event|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
168733|NCT01292642|B1|Baseline|Treatment|CBT plus NRT
168734|NCT01292642|P1|Participant Flow|Treatment|Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
168735|NCT01292642|O1|Outcome|Treatment|CBT plus NRT
168736|NCT01292642|O2|Outcome|Post Treatment - Cannabis Inhalations Per Day|
168737|NCT01292642|O1|Outcome|Baseline - Cannabis Inhalations Per Day|CBT plus NRT
168738|NCT01292642|O2|Outcome|PostTreatment - Cigarettes Per Day|CBT plus NRT
168739|NCT01292642|O1|Outcome|Baseline - Cigarettes Per Day|
168740|NCT01292642|E1|Reported Event|Treatment|CBT plus NRT
168741|NCT01292629|B1|Baseline|iSert® 251 Intraocular Lens|Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
168742|NCT01292629|P1|Participant Flow|iSert 251: iSert 251 Intraocular Lens|Implantation with the iSert® 251 Intraocular lens
168743|NCT01292629|O1|Outcome|iSert 251 Aphakik IOL|iSert 251: iSert 251 intraocular lens
168744|NCT01292629|O1|Outcome|iSert 251: iSert 251 Intraocular Lens|Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
168745|NCT01292629|E1|Reported Event|iSert 251: iSert 251 Intraocular Lens|Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
168746|NCT01292603|B6|Baseline|Total|Total of all reporting groups
168747|NCT01292603|B5|Baseline|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168748|NCT01292603|B4|Baseline|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168777|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168749|NCT01292603|B3|Baseline|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168750|NCT01292603|B2|Baseline|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168751|NCT01292603|B1|Baseline|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168752|NCT01292603|P6|Participant Flow|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168753|NCT01292603|P5|Participant Flow|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168754|NCT01292603|P4|Participant Flow|No SC Dose Received|These participants were withdrawn prior to SC treatment.
168755|NCT01292603|P3|Participant Flow|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168756|NCT01292603|P2|Participant Flow|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168757|NCT01292603|P1|Participant Flow|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 milligrams per square meter (mg/m^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168758|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168759|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168760|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168761|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168762|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
168776|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
169003|NCT01291784|P2|Participant Flow|Sub B|Subject B
168763|NCT01292603|O4|Outcome|Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168764|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168765|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168766|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168767|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
168768|NCT01292603|O4|Outcome|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168769|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168770|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168771|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168772|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168773|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168774|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168775|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168823|NCT01292473|B1|Baseline|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
168824|NCT01292473|P4|Participant Flow|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
168825|NCT01292473|P3|Participant Flow|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
168778|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168779|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168780|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168781|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168782|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168783|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168784|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168785|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168786|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168787|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168788|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168789|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168790|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168791|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168792|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168793|NCT01292603|E7|Reported Event|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168794|NCT01292603|E6|Reported Event|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168795|NCT01292603|E5|Reported Event|No SC Dose Received|These participants were withdrawn prior to SC treatment.
168796|NCT01292603|E4|Reported Event|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168797|NCT01292603|E3|Reported Event|Part 1: Rituximab SC 1870 mg|"PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168798|NCT01292603|E2|Reported Event|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168799|NCT01292603|E1|Reported Event|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
168800|NCT01292538|B3|Baseline|Total|Total of all reporting groups
168801|NCT01292538|B2|Baseline|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
168802|NCT01292538|B1|Baseline|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
168803|NCT01292538|P2|Participant Flow|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
168804|NCT01292538|P1|Participant Flow|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
168805|NCT01292538|O2|Outcome|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
168806|NCT01292538|O1|Outcome|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
168807|NCT01292538|E2|Reported Event|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
168808|NCT01292538|E1|Reported Event|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
168809|NCT01292486|B1|Baseline|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
168810|NCT01292486|P1|Participant Flow|All Per Protocol Patients|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
168811|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168812|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168813|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168814|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168815|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168816|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
168817|NCT01292486|O1|Outcome|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
168818|NCT01292486|E1|Reported Event|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
168819|NCT01292473|B5|Baseline|Total|Total of all reporting groups
168820|NCT01292473|B4|Baseline|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
168821|NCT01292473|B3|Baseline|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
168822|NCT01292473|B2|Baseline|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
168834|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168835|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168836|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168837|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168838|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168839|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168840|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168841|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168842|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168843|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168844|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168845|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168846|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168847|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168848|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168849|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168850|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168851|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168852|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
168853|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
168854|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168855|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168856|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
168857|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
168858|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
168859|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
168860|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
168861|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
168862|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
168863|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
168864|NCT01292473|E4|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
168865|NCT01292473|E3|Reported Event|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
168866|NCT01292473|E2|Reported Event|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
168867|NCT01292473|E1|Reported Event|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
168868|NCT01292304|B1|Baseline|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168869|NCT01292304|P1|Participant Flow|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168870|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168871|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168872|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168873|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168874|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168875|NCT01292304|E1|Reported Event|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
168876|NCT01292265|B1|Baseline|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168877|NCT01292265|P1|Participant Flow|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168878|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168879|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168880|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168881|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168882|NCT01292265|E1|Reported Event|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
168883|NCT01292239|B3|Baseline|Total|Total of all reporting groups
168884|NCT01292239|B2|Baseline|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
169004|NCT01291784|P1|Participant Flow|Sub A|Subject A
168885|NCT01292239|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168886|NCT01292239|P2|Participant Flow|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168887|NCT01292239|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168888|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168889|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168890|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168891|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168892|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168893|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168894|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168895|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168896|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168897|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168898|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168899|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168900|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168901|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168902|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168903|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168904|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168905|NCT01292239|E2|Reported Event|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
168906|NCT01292239|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
168907|NCT01292226|B1|Baseline|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168908|NCT01292226|P1|Participant Flow|Mycophenolate Mofetil (MMF) Monotherapy|Participants received an initial dose of MMF 1 gram (g), orally (PO), twice per day (BID), started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168909|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168910|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168911|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168912|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168913|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168914|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168915|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168916|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168917|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168918|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168919|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168920|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168921|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
169005|NCT01291784|O3|Outcome|Sub C|Subject C
168922|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168923|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168924|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168925|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168926|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168927|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168928|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168929|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168930|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168931|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168932|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168933|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168934|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168935|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168936|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168937|NCT01292226|E1|Reported Event|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
168938|NCT01292187|B3|Baseline|Total|Total of all reporting groups
168939|NCT01292187|B2|Baseline|Placebo Tablets|Patients who did not receive any active treatment, just placebo
168940|NCT01292187|B1|Baseline|rsCT Tablets|Patients who received oral calcitonin as an active treatment
168941|NCT01292187|P2|Participant Flow|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168942|NCT01292187|P1|Participant Flow|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
169006|NCT01291784|O2|Outcome|Sub B|Subject B
169007|NCT01291784|O1|Outcome|Sub A|Subject A
168943|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168944|NCT01292187|O1|Outcome|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168945|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168946|NCT01292187|O1|Outcome|Oral Calcitonin Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168947|NCT01292187|E2|Reported Event|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168948|NCT01292187|E1|Reported Event|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
168949|NCT01292135|B3|Baseline|Total|Total of all reporting groups
168950|NCT01292135|B2|Baseline|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168951|NCT01292135|B1|Baseline|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
168952|NCT01292135|P2|Participant Flow|PCI-32765 Plus Bendamustine/Rituximab (BR)|"PCI-32765: 420 mg daily~BR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).~Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)"
168953|NCT01292135|P1|Participant Flow|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|"PCI-32765: 420 mg daily~FCR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).~Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle~Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)"
168954|NCT01292135|O2|Outcome|PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
168955|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168956|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
168957|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168958|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
168959|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168960|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
168961|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168962|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
168963|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168964|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
168965|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168966|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
168967|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168968|NCT01292135|E2|Reported Event|PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
168969|NCT01292135|E1|Reported Event|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
168970|NCT01292070|B1|Baseline|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
168971|NCT01292070|P1|Participant Flow|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
169008|NCT01291784|O3|Outcome|Sub C|Subject C
169009|NCT01291784|O2|Outcome|Sub B|Subject B
169010|NCT01291784|O1|Outcome|Sub A|Subject A
169011|NCT01291784|O3|Outcome|Sub C|Subject C
168972|NCT01292070|O1|Outcome|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
168973|NCT01292070|E1|Reported Event|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
168974|NCT01292005|B3|Baseline|Total|Total of all reporting groups
168975|NCT01292005|B2|Baseline|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168976|NCT01292005|B1|Baseline|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168977|NCT01292005|P2|Participant Flow|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168978|NCT01292005|P1|Participant Flow|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168979|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168980|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168981|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168982|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168983|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168984|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168985|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168986|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168987|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168988|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168989|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168990|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168991|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168992|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168993|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168994|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168995|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168996|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168997|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168998|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
168999|NCT01292005|E2|Reported Event|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
169000|NCT01292005|E1|Reported Event|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
169001|NCT01291784|B1|Baseline|Phase 1 MF Subjects|3 subjects were enrolled in the study. The three subjects were treated at a GC1008 dose level of 1 mg/kg given intravenously over approximately 60 minutes and then repeated every 28 days for a total of 6 cycles in the core study period and then an additional 6 cycles in an extension phase.
169002|NCT01291784|P3|Participant Flow|Sub C|Subject C
169023|NCT01291498|B1|Baseline|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
169024|NCT01291498|P1|Participant Flow|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
169025|NCT01291498|O1|Outcome|HIFU Treatment|Allsubjects are planned to have HIFU Treatment
169026|NCT01291498|O1|Outcome|HIFU Treatment|Ablation of the parathyroid gland by HIFU Treatment
169027|NCT01291498|O1|Outcome|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
169028|NCT01291498|E1|Reported Event|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
169029|NCT01291277|B3|Baseline|Total|Total of all reporting groups
169030|NCT01291277|B2|Baseline|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169031|NCT01291277|B1|Baseline|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169032|NCT01291277|P2|Participant Flow|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169033|NCT01291277|P1|Participant Flow|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169034|NCT01291277|O2|Outcome|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169035|NCT01291277|O1|Outcome|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169036|NCT01291277|E2|Reported Event|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169037|NCT01291277|E1|Reported Event|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
169038|NCT01291264|B1|Baseline|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
169039|NCT01291264|P1|Participant Flow|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
169040|NCT01291264|O1|Outcome|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
169041|NCT01291264|E1|Reported Event|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
169042|NCT01291225|B3|Baseline|Total|Total of all reporting groups
169043|NCT01291225|B2|Baseline|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169044|NCT01291225|B1|Baseline|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169045|NCT01291225|P2|Participant Flow|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169046|NCT01291225|P1|Participant Flow|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169047|NCT01291225|O4|Outcome|Farms--Pickaway/Morrow Counties|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169048|NCT01291225|O3|Outcome|Farms--Ross County|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169049|NCT01291225|O2|Outcome|Playground--Circleville|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169050|NCT01291225|O1|Outcome|Playground--Chillicothe|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169051|NCT01291225|O2|Outcome|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169052|NCT01291225|O1|Outcome|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169053|NCT01291225|E2|Reported Event|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
169054|NCT01291225|E1|Reported Event|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
169055|NCT01291173|B5|Baseline|Total|Total of all reporting groups
169056|NCT01291173|B4|Baseline|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169057|NCT01291173|B3|Baseline|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169058|NCT01291173|B2|Baseline|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169059|NCT01291173|B1|Baseline|Placebo|Placebo capsule taken once daily for up to 11 weeks
169060|NCT01291173|P4|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169061|NCT01291173|P3|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169062|NCT01291173|P2|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169063|NCT01291173|P1|Participant Flow|Placebo|Placebo capsule taken once daily for up to 11 weeks
169064|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169065|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169066|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169067|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169068|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169069|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169070|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169071|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169072|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169073|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169074|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169075|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169076|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169077|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169078|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169079|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169080|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169081|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169082|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169083|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169084|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169085|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169086|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169087|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169088|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169089|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169090|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169091|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169092|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169093|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169094|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169095|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169096|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169097|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169098|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169099|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169100|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169101|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169102|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169103|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169104|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169105|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169106|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169107|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169108|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169109|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169110|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169111|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169112|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169113|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169114|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169115|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169116|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169117|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169118|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169119|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
169120|NCT01291173|E4|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
169121|NCT01291173|E3|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
169122|NCT01291173|E2|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
169123|NCT01291173|E1|Reported Event|Placebo|Placebo capsule taken once daily for up to 11 weeks
169124|NCT01291160|B3|Baseline|Total|Total of all reporting groups
169125|NCT01291160|B2|Baseline|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169126|NCT01291160|B1|Baseline|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169127|NCT01291160|P2|Participant Flow|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169128|NCT01291160|P1|Participant Flow|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169129|NCT01291160|O2|Outcome|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169130|NCT01291160|O1|Outcome|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169131|NCT01291160|E2|Reported Event|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169132|NCT01291160|E1|Reported Event|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
169133|NCT01291108|B5|Baseline|Total|Total of all reporting groups
169134|NCT01291108|B4|Baseline|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
169135|NCT01291108|B3|Baseline|Bimatoprost Followed by Bimatoprost + AGN-210669|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.
169136|NCT01291108|B2|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
169137|NCT01291108|B1|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
169138|NCT01291108|P6|Participant Flow|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169270|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169271|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
169139|NCT01291108|P5|Participant Flow|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
169140|NCT01291108|P4|Participant Flow|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
169141|NCT01291108|P3|Participant Flow|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169142|NCT01291108|P2|Participant Flow|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
169143|NCT01291108|P1|Participant Flow|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
169144|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
169145|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169146|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169147|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
169148|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169149|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169150|NCT01291108|E6|Reported Event|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169151|NCT01291108|E5|Reported Event|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
169152|NCT01291108|E4|Reported Event|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
169153|NCT01291108|E3|Reported Event|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
169154|NCT01291108|E2|Reported Event|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
169155|NCT01291108|E1|Reported Event|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
169156|NCT01291056|B3|Baseline|Total|Total of all reporting groups
169157|NCT01291056|B2|Baseline|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
169158|NCT01291056|B1|Baseline|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
169159|NCT01291056|P2|Participant Flow|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
169160|NCT01291056|P1|Participant Flow|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
169161|NCT01291056|O2|Outcome|Placebo|Placebo
169162|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
169163|NCT01291056|O2|Outcome|Placebo|Placebo
169164|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
169165|NCT01291056|O2|Outcome|Placebo|Placebo
169166|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
169167|NCT01291056|O2|Outcome|Placebo|Placebo
169168|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
169169|NCT01291056|E2|Reported Event|Placebo, Then Clomiphene Citrate|Placebo daily, then Clomiphene Citrate 50 milligrams daily
169170|NCT01291056|E1|Reported Event|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
169171|NCT01291017|B1|Baseline|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169172|NCT01291017|P1|Participant Flow|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169173|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169174|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169175|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169176|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169177|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169178|NCT01291017|E1|Reported Event|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
169179|NCT01290978|B1|Baseline|ChloraPrep , DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
169180|NCT01290978|P1|Participant Flow|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
169181|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
169182|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
169183|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
169184|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
169185|NCT01290978|E1|Reported Event|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
169186|NCT01290952|B3|Baseline|Total|Total of all reporting groups
169187|NCT01290952|B2|Baseline|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
169188|NCT01290952|B1|Baseline|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
169189|NCT01290952|P2|Participant Flow|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
169190|NCT01290952|P1|Participant Flow|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
169191|NCT01290952|O2|Outcome|Off-pump Bypass Surgery|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
169192|NCT01290952|O1|Outcome|On-pump Bypass Surgery|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
169193|NCT01290952|O2|Outcome|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
169194|NCT01290952|O1|Outcome|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
169195|NCT01290952|E2|Reported Event|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
169196|NCT01290952|E1|Reported Event|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
169197|NCT01290913|B1|Baseline|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
169198|NCT01290913|P1|Participant Flow|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
169199|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
169200|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
169201|NCT01290913|E1|Reported Event|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
169202|NCT01290887|B3|Baseline|Total|Total of all reporting groups
169203|NCT01290887|B2|Baseline|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169204|NCT01290887|B1|Baseline|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169205|NCT01290887|P2|Participant Flow|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169206|NCT01290887|P1|Participant Flow|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169207|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169208|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169209|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169210|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169272|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169211|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169212|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169213|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169214|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169215|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169216|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169217|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169218|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169219|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169220|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169221|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169222|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169223|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169224|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169225|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169226|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169227|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169228|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169229|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169230|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169231|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169232|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169233|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169234|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169235|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169236|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169237|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169273|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
169238|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169239|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169240|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169241|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
169242|NCT01290887|E1|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
169243|NCT01290822|B1|Baseline|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
169244|NCT01290822|P1|Participant Flow|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
169245|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169246|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169247|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169248|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169249|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169250|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
169251|NCT01290822|E1|Reported Event|All Subjects in the Study|This includes all subjects in the study
169252|NCT01290796|B1|Baseline|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
169253|NCT01290796|P1|Participant Flow|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
169254|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
169255|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
169256|NCT01290796|E1|Reported Event|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
169257|NCT01290757|B3|Baseline|Total|Total of all reporting groups
169258|NCT01290757|B2|Baseline|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
169259|NCT01290757|B1|Baseline|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
169260|NCT01290757|P2|Participant Flow|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
169261|NCT01290757|P1|Participant Flow|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
169262|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169263|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
169264|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169265|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
169266|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169267|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
169268|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
169275|NCT01290757|E1|Reported Event|Qualicaps|Dabigatran 150mg in Qualicaps
169276|NCT01290731|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169277|NCT01290731|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169278|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169279|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169280|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169281|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169282|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169283|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169284|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169285|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169286|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169287|NCT01290731|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
169288|NCT01290718|B1|Baseline|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169289|NCT01290718|P1|Participant Flow|Capecitabine Plus (+) Trastuzumab|Participants received capecitabine 900 milligrams per square meter (mg/m^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169290|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169291|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
188751|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
169292|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169293|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169294|NCT01290718|E1|Reported Event|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
169295|NCT01290679|B3|Baseline|Total|Total of all reporting groups
169296|NCT01290679|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169297|NCT01290679|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169298|NCT01290679|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169299|NCT01290679|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169300|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169301|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169302|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169303|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169304|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169305|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169306|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169307|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169308|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169309|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169310|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169311|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169381|NCT01290640|E1|Reported Event|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
169382|NCT01290627|B4|Baseline|Total|Total of all reporting groups
169312|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169313|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169314|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169315|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169316|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169317|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169318|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169319|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169320|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169321|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169322|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169323|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169324|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169325|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169326|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169327|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169328|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169329|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169330|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169331|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169383|NCT01290627|B3|Baseline|Control|Subjects with normal knees
169332|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169333|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169334|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169335|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169336|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169337|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169338|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169339|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169340|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169341|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169342|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169343|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169344|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169345|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169346|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169347|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169348|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169349|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169350|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169351|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169440|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
169352|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169353|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169354|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169355|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169356|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169357|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169358|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169359|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169360|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169361|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169362|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169363|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169364|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169365|NCT01290679|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
169366|NCT01290679|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169367|NCT01290666|B1|Baseline|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
169368|NCT01290666|P1|Participant Flow|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
169369|NCT01290666|O1|Outcome|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
169370|NCT01290666|E1|Reported Event|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
169371|NCT01290640|B3|Baseline|Total|Total of all reporting groups
169372|NCT01290640|B2|Baseline|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
169373|NCT01290640|B1|Baseline|PFC RP TC3 TKA|
169374|NCT01290640|P2|Participant Flow|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
169375|NCT01290640|P1|Participant Flow|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
169376|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
169377|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
169378|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
169379|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
169380|NCT01290640|E2|Reported Event|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
169384|NCT01290627|B2|Baseline|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169385|NCT01290627|B1|Baseline|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169386|NCT01290627|P3|Participant Flow|Control|Subjects with normal knees
169387|NCT01290627|P2|Participant Flow|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169388|NCT01290627|P1|Participant Flow|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169389|NCT01290627|O3|Outcome|Control|Subjects with normal knees
169390|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169391|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169392|NCT01290627|O3|Outcome|Control|Subjects with normal knees
169393|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169394|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169395|NCT01290627|O3|Outcome|Control|Subjects with normal knees
169396|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169397|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169398|NCT01290627|O3|Outcome|Control|Subjects with normal knees
169399|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169400|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169401|NCT01290627|O3|Outcome|Control|Subjects with normal knees
169402|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169403|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169404|NCT01290627|E3|Reported Event|Control|Subjects with normal knees
169405|NCT01290627|E2|Reported Event|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169406|NCT01290627|E1|Reported Event|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
169407|NCT01290614|B3|Baseline|Total|Total of all reporting groups
169408|NCT01290614|B2|Baseline|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
169409|NCT01290614|B1|Baseline|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
169410|NCT01290614|P2|Participant Flow|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
169411|NCT01290614|P1|Participant Flow|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
169412|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
169413|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
188752|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
169414|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
169415|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
169416|NCT01290614|E2|Reported Event|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
169417|NCT01290614|E1|Reported Event|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
169418|NCT01290536|B1|Baseline|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169419|NCT01290536|P1|Participant Flow|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169420|NCT01290536|O3|Outcome|Other Tumors - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169421|NCT01290536|O2|Outcome|Neuroendocrine - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169422|NCT01290536|O1|Outcome|Colorectal - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169423|NCT01290536|O1|Outcome|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169424|NCT01290536|E1|Reported Event|Yttrium-90 Liver Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
169425|NCT01290523|B1|Baseline|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
169426|NCT01290523|P1|Participant Flow|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
169427|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
169428|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
169429|NCT01290523|E1|Reported Event|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
169430|NCT01290484|B1|Baseline|Sildenafil|Male and female subjects between the ages of 6 months and 10 years, weighing at least 8 kg and had been given a diagnosis of a lymphatic malformation of at least 3 cm based on clinical and radiologic criteria. Macrocystic, microcystic, or mixed lymphatic malformations involving any location on the body were included. Lymphatic malformations associated with an incomplete response to previous treatments, a risk of functional or aesthetic impairment, or local complications were included.
169431|NCT01290484|P1|Participant Flow|Sildenafil|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).
169432|NCT01290484|O1|Outcome|Sildenafil|The primary outcome was the effect of sildenafil on lymphatic malformation volume. Response to sildenafil was characterized by any decrease in lymphatic malformation volume. Lymphatic malformations volumes were assessed blindly by MRI volume segmentation analysis at baseline and after 20 weeks of sildenafil. 4 subjects had a lymphatic malformation volume decrease.
169433|NCT01290484|E1|Reported Event|Sildenafil|Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.
169434|NCT01290341|B3|Baseline|Total|Total of all reporting groups
169435|NCT01290341|B2|Baseline|Placebo|Topical; applied once daily for two weeks.
169436|NCT01290341|B1|Baseline|NAFT-600|Topical; applied once daily for two weeks
169437|NCT01290341|P2|Participant Flow|Placebo|Topical; applied once daily for two weeks.
169438|NCT01290341|P1|Participant Flow|NAFT-600|Topical; applied once daily for two weeks
169439|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
169441|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
169442|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
169443|NCT01290341|E2|Reported Event|Placebo|Topical; applied once daily for two weeks.
169444|NCT01290341|E1|Reported Event|NAFT-600|Topical; applied once daily for two weeks
169445|NCT01290224|B1|Baseline|Sham Procedure + Scrambler Treatment|
169446|NCT01290224|P1|Participant Flow|Sham Procedure + Scrambler Treatment|
169447|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169448|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169449|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169450|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169451|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169452|NCT01290224|O2|Outcome|Scrambler Therapy (Day 2)|
169453|NCT01290224|O1|Outcome|Sham Procedure (Day 1 )|
169454|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
169455|NCT01290224|E1|Reported Event|Sham Procedure + Scrambler Treatment|
169456|NCT01290094|B1|Baseline|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169457|NCT01290094|P1|Participant Flow|Ibandronate|Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169458|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169459|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169460|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169461|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169462|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169463|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169464|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169465|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
169466|NCT01290094|E1|Reported Event|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
169467|NCT01290029|B1|Baseline|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169468|NCT01290029|P1|Participant Flow|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169469|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169470|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169471|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169472|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169473|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169474|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169475|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169476|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169477|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169478|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169479|NCT01290029|E1|Reported Event|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
169480|NCT01289990|B14|Baseline|Total|Total of all reporting groups
169481|NCT01289990|B13|Baseline|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169482|NCT01289990|B12|Baseline|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169483|NCT01289990|B11|Baseline|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169484|NCT01289990|B10|Baseline|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169485|NCT01289990|B9|Baseline|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169486|NCT01289990|B8|Baseline|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
169487|NCT01289990|B7|Baseline|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169488|NCT01289990|B6|Baseline|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169489|NCT01289990|B5|Baseline|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169490|NCT01289990|B4|Baseline|Sitagliptin 100 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100 mg: Sitagliptin once daily"
169491|NCT01289990|B3|Baseline|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169492|NCT01289990|B2|Baseline|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169493|NCT01289990|B1|Baseline|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169494|NCT01289990|P13|Participant Flow|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169495|NCT01289990|P12|Participant Flow|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169496|NCT01289990|P11|Participant Flow|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169497|NCT01289990|P10|Participant Flow|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169498|NCT01289990|P9|Participant Flow|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169499|NCT01289990|P8|Participant Flow|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
169500|NCT01289990|P7|Participant Flow|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169501|NCT01289990|P6|Participant Flow|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169502|NCT01289990|P5|Participant Flow|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169503|NCT01289990|P4|Participant Flow|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
169504|NCT01289990|P3|Participant Flow|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169505|NCT01289990|P2|Participant Flow|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
169506|NCT01289990|P1|Participant Flow|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169507|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169508|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169509|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169510|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169511|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169512|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169513|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169514|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169515|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169516|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169517|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169518|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169519|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169520|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169521|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169522|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169523|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169524|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169525|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169526|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169527|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169528|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169529|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169530|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169531|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169532|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169533|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169534|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169535|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169536|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169537|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169538|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169539|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169540|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169541|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169542|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169543|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169544|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169545|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169546|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169547|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169548|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169549|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169550|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169551|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169552|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169553|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169554|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169555|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169556|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169557|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169558|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169559|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169560|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169561|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169562|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169563|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169564|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169565|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169566|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169567|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169568|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169569|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169570|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169571|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169572|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169573|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169574|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169575|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169576|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169577|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169578|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169579|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
188753|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
169580|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169581|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169582|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169583|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169584|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169585|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169586|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169587|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169588|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169589|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169590|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169591|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169592|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169593|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169594|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169595|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169596|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169597|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169598|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169599|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169600|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169601|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169602|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169603|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169604|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169605|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169606|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169607|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169608|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169609|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169821|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
188754|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
169610|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169611|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169612|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169613|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169614|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169615|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169616|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169617|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169618|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169619|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169620|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169621|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169622|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169623|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169624|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169625|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169626|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169627|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169628|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169629|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169630|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169631|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169632|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169633|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169634|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169635|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169636|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169637|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169638|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169639|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169640|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169641|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169642|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169643|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169644|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169645|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169646|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169647|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169648|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169649|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169650|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169651|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169652|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169653|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169654|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169655|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169656|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169657|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169658|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169659|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169660|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169661|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169662|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169663|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169664|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169665|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
169666|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169667|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169668|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
169669|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
169670|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169671|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
170105|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
169672|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
169673|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169674|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
169675|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
169676|NCT01289990|E13|Reported Event|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169677|NCT01289990|E12|Reported Event|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169678|NCT01289990|E11|Reported Event|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169679|NCT01289990|E10|Reported Event|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169680|NCT01289990|E9|Reported Event|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169681|NCT01289990|E8|Reported Event|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
169682|NCT01289990|E7|Reported Event|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
169683|NCT01289990|E6|Reported Event|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
169684|NCT01289990|E5|Reported Event|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
169685|NCT01289990|E4|Reported Event|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
169686|NCT01289990|E3|Reported Event|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169687|NCT01289990|E2|Reported Event|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
169688|NCT01289990|E1|Reported Event|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
169689|NCT01289847|B1|Baseline|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169690|NCT01289847|P1|Participant Flow|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169691|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169692|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169693|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169694|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169695|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169696|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169697|NCT01289847|E1|Reported Event|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
169698|NCT01289821|B1|Baseline|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169822|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
169699|NCT01289821|P1|Participant Flow|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169700|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169701|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169702|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169703|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169704|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169705|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169706|NCT01289821|E1|Reported Event|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L‑folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
169707|NCT01289782|B3|Baseline|Total|Total of all reporting groups
169708|NCT01289782|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169709|NCT01289782|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169710|NCT01289782|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169711|NCT01289782|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169712|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169713|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169714|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169715|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169716|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169717|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169718|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169719|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169720|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169721|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169722|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169723|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169724|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169725|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169726|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169727|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169728|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169729|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169730|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169731|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169732|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169733|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169734|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169735|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169736|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169737|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169738|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169739|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169740|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169741|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169742|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169743|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169744|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169745|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169746|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169747|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169748|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169749|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169750|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169751|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169752|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169753|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169823|NCT01289574|E3|Reported Event|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169824|NCT01289574|E2|Reported Event|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169754|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169755|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169756|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169757|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169758|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169759|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169760|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169761|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169762|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169763|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169764|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169765|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169766|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169767|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169768|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169769|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169770|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169771|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169772|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169773|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169825|NCT01289574|E1|Reported Event|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
169826|NCT01289548|B4|Baseline|Total|Total of all reporting groups
169774|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169775|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169776|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169777|NCT01289782|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
169778|NCT01289782|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
169779|NCT01289639|B4|Baseline|Total|Total of all reporting groups
169780|NCT01289639|B3|Baseline|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169781|NCT01289639|B2|Baseline|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169782|NCT01289639|B1|Baseline|Arm 1|"matching placebo for fenofibrate 1 po qd~matching placebo for pioglitazone 1 po qd"
169783|NCT01289639|P3|Participant Flow|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169784|NCT01289639|P2|Participant Flow|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169785|NCT01289639|P1|Participant Flow|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169786|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169787|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169788|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169789|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169790|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169791|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169792|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169793|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169794|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169795|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169796|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169797|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169798|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169799|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169800|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169801|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169802|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169803|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169804|NCT01289639|E3|Reported Event|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
169805|NCT01289639|E2|Reported Event|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
169806|NCT01289639|E1|Reported Event|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
169807|NCT01289574|B4|Baseline|Total|Total of all reporting groups
169808|NCT01289574|B3|Baseline|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169809|NCT01289574|B2|Baseline|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169810|NCT01289574|B1|Baseline|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
169811|NCT01289574|P3|Participant Flow|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169812|NCT01289574|P2|Participant Flow|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169813|NCT01289574|P1|Participant Flow|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
169814|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169815|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169816|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
169817|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169818|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169819|NCT01289574|O1|Outcome|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
169820|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
169827|NCT01289548|B3|Baseline|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169828|NCT01289548|B2|Baseline|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169829|NCT01289548|B1|Baseline|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169830|NCT01289548|P3|Participant Flow|Recipient PIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169831|NCT01289548|P2|Participant Flow|Donor RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169832|NCT01289548|P1|Participant Flow|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
169833|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169834|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169835|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169836|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169837|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169838|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169839|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169840|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169841|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169842|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169843|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169844|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169845|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169846|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169847|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169848|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169849|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169850|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169851|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169852|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169853|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169854|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169855|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169856|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169857|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169858|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169859|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169860|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169931|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169861|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169862|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169863|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169864|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169865|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169866|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169867|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169868|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169869|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169870|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169871|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169872|NCT01289548|E3|Reported Event|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
169873|NCT01289548|E2|Reported Event|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
169874|NCT01289548|E1|Reported Event|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
169875|NCT01289418|B4|Baseline|Total|Total of all reporting groups
169876|NCT01289418|B3|Baseline|Health Care Workers in Halifax|Health Care Workers from Halifax
169877|NCT01289418|B2|Baseline|Health Care Workers in Toronto|Health Care Workers from Toronto
169878|NCT01289418|B1|Baseline|Health Care Workers in Quebec|Health care workers from Quebec
169879|NCT01289418|P1|Participant Flow|Health Care Workers|Health care workers from all hospitals
169880|NCT01289418|O1|Outcome|Health Care Workers From CHUQ Hospitals|
169881|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid email address
169882|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid e-mail address
169883|NCT01289418|E1|Reported Event|Health Care Workers From CHUQ Hospitals|
169884|NCT01289392|B4|Baseline|Total|Total of all reporting groups
169885|NCT01289392|B3|Baseline|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
169886|NCT01289392|B2|Baseline|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169887|NCT01289392|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169888|NCT01289392|P3|Participant Flow|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
169889|NCT01289392|P2|Participant Flow|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169890|NCT01289392|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169891|NCT01289392|O3|Outcome|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
169892|NCT01289392|O2|Outcome|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169893|NCT01289392|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169894|NCT01289392|E3|Reported Event|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
169895|NCT01289392|E2|Reported Event|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169896|NCT01289392|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
169932|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169897|NCT01289210|B1|Baseline|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
169898|NCT01289210|P1|Participant Flow|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
169899|NCT01289210|O1|Outcome|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
169900|NCT01289210|E1|Reported Event|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
169901|NCT01289119|B7|Baseline|Total|Total of all reporting groups
169902|NCT01289119|B6|Baseline|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169903|NCT01289119|B5|Baseline|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169904|NCT01289119|B4|Baseline|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169905|NCT01289119|B3|Baseline|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169906|NCT01289119|B2|Baseline|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169907|NCT01289119|B1|Baseline|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169908|NCT01289119|P6|Participant Flow|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169909|NCT01289119|P5|Participant Flow|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169910|NCT01289119|P4|Participant Flow|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169911|NCT01289119|P3|Participant Flow|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169912|NCT01289119|P2|Participant Flow|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169913|NCT01289119|P1|Participant Flow|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169914|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169915|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169916|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169917|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169918|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169919|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169920|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169921|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169922|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169923|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169924|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169925|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169926|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169927|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169928|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169929|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169930|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169933|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169934|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169935|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169936|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169937|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169938|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169939|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169940|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169941|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169942|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169943|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169944|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169945|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169946|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169947|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169948|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169949|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169950|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169951|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169952|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169953|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169954|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169955|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169956|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169957|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169958|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169959|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169960|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169961|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169962|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169963|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169964|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169965|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169966|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169967|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169968|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169969|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169970|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169971|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169972|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169973|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169974|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169975|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169976|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169977|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169978|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169979|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169980|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169981|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169982|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169983|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169984|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169985|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169986|NCT01289119|E6|Reported Event|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
169987|NCT01289119|E5|Reported Event|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169988|NCT01289119|E4|Reported Event|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169989|NCT01289119|E3|Reported Event|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
169990|NCT01289119|E2|Reported Event|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
169991|NCT01289119|E1|Reported Event|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
169992|NCT01289080|B3|Baseline|Total|Total of all reporting groups
169993|NCT01289080|B2|Baseline|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
169994|NCT01289080|B1|Baseline|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
169995|NCT01289080|P2|Participant Flow|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
169996|NCT01289080|P1|Participant Flow|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
169997|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
169998|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
169999|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
170000|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170001|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
170002|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170003|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
170004|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170005|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170006|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170007|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170008|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170009|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170010|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170011|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170012|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170013|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
170014|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170015|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170016|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170017|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170018|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170019|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170020|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170021|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
170022|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170023|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
170024|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
170025|NCT01289080|E1|Reported Event|Brexpiprazole 3mg|Participants with normal renal function and severe renal impairment were administered 3 mg brexpiprazole.
170026|NCT01289041|B1|Baseline|All Patients|
170027|NCT01289041|P1|Participant Flow|All Patients|
170028|NCT01289041|O3|Outcome|All Patients|
170029|NCT01289041|O2|Outcome|Non-Activated Pl3K|
170030|NCT01289041|O1|Outcome|Activated Pl3K|
170031|NCT01289041|O3|Outcome|All Patients|
170032|NCT01289041|O2|Outcome|Non-Activated Pl3K|
170033|NCT01289041|O1|Outcome|Activated Pl3K|
170034|NCT01289041|O3|Outcome|All Patients|
170035|NCT01289041|O2|Outcome|Non-Activated Pl3K|
170036|NCT01289041|O1|Outcome|Activated Pl3K|
170037|NCT01289041|E1|Reported Event|All Patients|
170038|NCT01289028|B1|Baseline|Nilotinib|
170039|NCT01289028|P1|Participant Flow|Nilotinib|
170040|NCT01289028|O1|Outcome|Nilotinib|
170041|NCT01289028|O1|Outcome|Nilotinib|
170042|NCT01289028|O1|Outcome|Nilotinib|
170043|NCT01289028|O1|Outcome|Nilotinib|
170044|NCT01289028|O1|Outcome|Nilotinib|Per Protocol population
170045|NCT01289028|O1|Outcome|Nilotinib|ITT
170046|NCT01289028|O1|Outcome|Nilotinib|
170047|NCT01289028|O1|Outcome|Nilotinib|
170048|NCT01289028|O1|Outcome|Nilotinib|
170049|NCT01289028|E1|Reported Event|All Patients|All patients
170050|NCT01289015|B3|Baseline|Total|Total of all reporting groups
170051|NCT01289015|B2|Baseline|Placebo|Placebo : Topical; applied once daily for two weeks
170052|NCT01289015|B1|Baseline|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
170053|NCT01289015|P2|Participant Flow|Placebo|Placebo : Topical; applied once daily for two weeks
170054|NCT01289015|P1|Participant Flow|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
170055|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
170056|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
170057|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
170058|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
170059|NCT01289015|E2|Reported Event|Placebo|Placebo : Topical; applied once daily for two weeks
170060|NCT01289015|E1|Reported Event|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
170061|NCT01288911|B3|Baseline|Total|Total of all reporting groups
170062|NCT01288911|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170063|NCT01288911|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170064|NCT01288911|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170065|NCT01288911|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170066|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170067|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170068|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170104|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
170069|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170070|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170071|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170072|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170073|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170074|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170075|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170076|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170077|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170078|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170079|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170080|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170081|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170082|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170083|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170084|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170085|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170086|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170087|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170088|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170089|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170090|NCT01288911|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170091|NCT01288911|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
170092|NCT01288859|B1|Baseline|All Study Participants|All participants followed all the periods
170093|NCT01288859|P6|Participant Flow|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
170094|NCT01288859|P5|Participant Flow|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
170095|NCT01288859|P4|Participant Flow|Control Cream|Subjects consumed 3 nut cream portions (33g each).
170096|NCT01288859|P3|Participant Flow|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
170097|NCT01288859|P2|Participant Flow|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
170098|NCT01288859|P1|Participant Flow|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
170099|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
170100|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
170101|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
170102|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
170103|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
170106|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
170107|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
170108|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
170109|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
170110|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
170111|NCT01288859|O6|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
170112|NCT01288859|O5|Outcome|Free Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form
170113|NCT01288859|O4|Outcome|Control Cream|subjects consumed cocoa-nut cream
170114|NCT01288859|O3|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein
170115|NCT01288859|O2|Outcome|Encapsulated Curcumin|subjects consumed bread enriched with encapsulated curcumin
170116|NCT01288859|O1|Outcome|Free Curcumin|subjects consumed bread enriched with free curcumin
170117|NCT01288859|E6|Reported Event|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
170118|NCT01288859|E5|Reported Event|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
170119|NCT01288859|E4|Reported Event|Control Cream|Subjects consumed 3 nut cream portions (33g each).
170120|NCT01288859|E3|Reported Event|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
170121|NCT01288859|E2|Reported Event|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
170122|NCT01288859|E1|Reported Event|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
170123|NCT01288781|B3|Baseline|Total|Total of all reporting groups
170124|NCT01288781|B2|Baseline|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170125|NCT01288781|B1|Baseline|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170126|NCT01288781|P2|Participant Flow|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170127|NCT01288781|P1|Participant Flow|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170128|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170129|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170130|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170131|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170132|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170133|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170134|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170135|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170136|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170137|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170138|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170139|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170140|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170141|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170142|NCT01288781|E2|Reported Event|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170143|NCT01288781|E1|Reported Event|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
170144|NCT01288612|B4|Baseline|Total|Total of all reporting groups
170145|NCT01288612|B3|Baseline|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170146|NCT01288612|B2|Baseline|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170185|NCT01288469|B1|Baseline|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170147|NCT01288612|B1|Baseline|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170148|NCT01288612|P3|Participant Flow|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170149|NCT01288612|P2|Participant Flow|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170150|NCT01288612|P1|Participant Flow|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170151|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170152|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170153|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170154|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170155|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170156|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170157|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170158|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170159|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170160|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170161|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170162|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170163|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170164|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170186|NCT01288469|P3|Participant Flow|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170165|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170166|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170167|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170168|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170169|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170170|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170171|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170172|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170173|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170174|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170175|NCT01288612|E3|Reported Event|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170176|NCT01288612|E2|Reported Event|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
170177|NCT01288612|E1|Reported Event|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
170178|NCT01288534|B1|Baseline|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
170179|NCT01288534|P1|Participant Flow|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
170180|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
170181|NCT01288534|E1|Reported Event|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
170182|NCT01288469|B4|Baseline|Total|Total of all reporting groups
170183|NCT01288469|B3|Baseline|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170184|NCT01288469|B2|Baseline|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
188755|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
170187|NCT01288469|P2|Participant Flow|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170188|NCT01288469|P1|Participant Flow|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170189|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170190|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170191|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170192|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170193|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170194|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170195|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170196|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170197|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170198|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170199|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170200|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170201|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170202|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170203|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170204|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170205|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170206|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170207|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170208|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170209|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170210|NCT01288469|E3|Reported Event|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170211|NCT01288469|E2|Reported Event|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
170212|NCT01288469|E1|Reported Event|Placebo + Atorvastatin 80mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
170213|NCT01288443|B7|Baseline|Total|Total of all reporting groups
170214|NCT01288443|B6|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170215|NCT01288443|B5|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170216|NCT01288443|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170217|NCT01288443|B3|Baseline|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170218|NCT01288443|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170219|NCT01288443|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170220|NCT01288443|P6|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170221|NCT01288443|P5|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170222|NCT01288443|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170223|NCT01288443|P3|Participant Flow|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170224|NCT01288443|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170225|NCT01288443|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
170226|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170227|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170228|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
188756|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
170229|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170230|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170231|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170232|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170233|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170234|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170235|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170236|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170237|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170238|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170239|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170240|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170241|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170242|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170243|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170244|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170245|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170246|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170247|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170248|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170249|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170250|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170251|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170252|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170253|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170254|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170255|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170256|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170257|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170258|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170259|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170260|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170261|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170262|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170263|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170264|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170265|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170266|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170267|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170268|NCT01288443|E6|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170269|NCT01288443|E5|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170270|NCT01288443|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170271|NCT01288443|E3|Reported Event|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170272|NCT01288443|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
170273|NCT01288443|E1|Reported Event|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
170355|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170274|NCT01288287|B1|Baseline|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
170275|NCT01288287|P1|Participant Flow|All Patients|Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
170276|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170277|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170278|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170279|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170280|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170281|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170282|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170283|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170284|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170285|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
170286|NCT01288287|E1|Reported Event|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
170287|NCT01288209|B3|Baseline|Total|Total of all reporting groups
170288|NCT01288209|B2|Baseline|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170289|NCT01288209|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170290|NCT01288209|P2|Participant Flow|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170291|NCT01288209|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170292|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170293|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170294|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170295|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170356|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170839|NCT01286207|B3|Baseline|Standard Care|Standard care at onset of migraine attack
170296|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170297|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170298|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170299|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170300|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170301|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170302|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170303|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170304|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170305|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170306|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170307|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170308|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170309|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170310|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170311|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170357|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170312|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170313|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
170314|NCT01288209|E2|Reported Event|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170315|NCT01288209|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
170316|NCT01288079|B5|Baseline|Total|Total of all reporting groups
170317|NCT01288079|B4|Baseline|Placebo|
170318|NCT01288079|B3|Baseline|60 mg QD Duloxetine|
170319|NCT01288079|B2|Baseline|4 mg BID TC-5214|
170320|NCT01288079|B1|Baseline|1 mg BID TC-5214|
170321|NCT01288079|P4|Participant Flow|Placebo|
170322|NCT01288079|P3|Participant Flow|60 mg QD Duloxetine|
170323|NCT01288079|P2|Participant Flow|4 mg BID TC-5214|
170324|NCT01288079|P1|Participant Flow|1 mg BID TC-5214|
170325|NCT01288079|O4|Outcome|Placebo|
170326|NCT01288079|O3|Outcome|60 mg QD Duloxetine|
170327|NCT01288079|O2|Outcome|4 mg BID TC-5214|
170328|NCT01288079|O1|Outcome|1 mg BID TC-5214|
170329|NCT01288079|E4|Reported Event|Placebo|
170330|NCT01288079|E3|Reported Event|60 mg QD Duloxetine|
170331|NCT01288079|E2|Reported Event|4 mg BID TC-5214|
170332|NCT01288079|E1|Reported Event|1 mg BID TC-5214|
170333|NCT01288027|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170334|NCT01288027|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170335|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170336|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170337|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170338|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170339|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170340|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170341|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170342|NCT01288027|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
170343|NCT01287897|B5|Baseline|Total|Total of all reporting groups
170344|NCT01287897|B4|Baseline|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170345|NCT01287897|B3|Baseline|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170346|NCT01287897|B2|Baseline|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170347|NCT01287897|B1|Baseline|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170348|NCT01287897|P4|Participant Flow|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170349|NCT01287897|P3|Participant Flow|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170350|NCT01287897|P2|Participant Flow|PF-04236921 10 Milligram (mg)|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170351|NCT01287897|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170352|NCT01287897|O4|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170353|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170354|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170358|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170359|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170360|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170361|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170362|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170363|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170364|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170365|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170366|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170367|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170368|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170369|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170370|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170371|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170372|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170373|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170374|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170375|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170376|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170377|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170378|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170379|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170380|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170381|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170382|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170383|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170384|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170385|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170386|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170387|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170388|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170389|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170390|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170391|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170392|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170393|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170394|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170395|NCT01287897|E4|Reported Event|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170396|NCT01287897|E3|Reported Event|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170397|NCT01287897|E2|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170398|NCT01287897|E1|Reported Event|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
170399|NCT01287832|B3|Baseline|Total|Total of all reporting groups
170400|NCT01287832|B2|Baseline|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170401|NCT01287832|B1|Baseline|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170402|NCT01287832|P2|Participant Flow|High-dose Daptomycin|Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170403|NCT01287832|P1|Participant Flow|High Dose Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170404|NCT01287832|O2|Outcome|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170405|NCT01287832|O1|Outcome|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170406|NCT01287832|E2|Reported Event|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170407|NCT01287832|E1|Reported Event|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
170408|NCT01287754|B3|Baseline|Total|Total of all reporting groups
170409|NCT01287754|B2|Baseline|Untreated|Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
170410|NCT01287754|B1|Baseline|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170411|NCT01287754|P2|Participant Flow|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
170412|NCT01287754|P1|Participant Flow|Erlotinib|Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.
170413|NCT01287754|O1|Outcome|All Participants|All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
170414|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
170415|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170416|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
170417|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170418|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170419|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170510|NCT01287221|B1|Baseline|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170420|NCT01287754|E1|Reported Event|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
170421|NCT01287611|B3|Baseline|Total|Total of all reporting groups
170422|NCT01287611|B2|Baseline|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
170423|NCT01287611|B1|Baseline|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
170424|NCT01287611|P2|Participant Flow|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
170425|NCT01287611|P1|Participant Flow|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
170426|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|"Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.~Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing"
170427|NCT01287611|O1|Outcome|Purse String Closure Technique|"Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.~Purse string closure technique: Uterine Kerr incision will be closed with purse string suture"
170428|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
170429|NCT01287611|O1|Outcome|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
170430|NCT01287611|E2|Reported Event|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
170431|NCT01287611|E1|Reported Event|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
170432|NCT01287416|B3|Baseline|Total|Total of all reporting groups
170433|NCT01287416|B2|Baseline|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170434|NCT01287416|B1|Baseline|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170435|NCT01287416|P2|Participant Flow|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170436|NCT01287416|P1|Participant Flow|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170437|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170447|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170438|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170439|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170440|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170441|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170442|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170443|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170444|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170445|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170446|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170511|NCT01287221|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170448|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170449|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170450|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170451|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170452|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170453|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170454|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170455|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170456|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170512|NCT01287221|P1|Participant Flow|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170457|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170458|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170459|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170460|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170461|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170462|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170463|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170464|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170465|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170488|NCT01287364|P2|Participant Flow|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
170466|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170467|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170468|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170469|NCT01287416|E2|Reported Event|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
170470|NCT01287416|E1|Reported Event|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
170471|NCT01287403|B1|Baseline|Entire Study Population|Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
170472|NCT01287403|P1|Participant Flow|Six Products (Flours) Assigned Randomly (Cross Over)|"In a crossover design, all subjects were administered the 6 following products in a randomized order:~Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).~Refined wheat flour: a treated cereal flour mixed with milk (negative control).~Liquid whole grain wheat flour: a treated cereal flour mixed with milk.~Liquid wholegrain barley flour: a treated cereal flour mixed with milk.~Wholegrain wheat flour: a treated cereal flour mixed with milk.~Wholegrain barley flour: a treated cereal flour mixed with milk."
170473|NCT01287403|O6|Outcome|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
170474|NCT01287403|O5|Outcome|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
170475|NCT01287403|O4|Outcome|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
170476|NCT01287403|O3|Outcome|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
170477|NCT01287403|O2|Outcome|Refined Wheat Flour|A treated cereal flour mixed with milk(negative control).
170478|NCT01287403|O1|Outcome|Esterase Whole Grain Wheat Flour|A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
170479|NCT01287403|E6|Reported Event|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
170480|NCT01287403|E5|Reported Event|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
170481|NCT01287403|E4|Reported Event|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
170482|NCT01287403|E3|Reported Event|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
170483|NCT01287403|E2|Reported Event|Esterase Wholegrain Wheat Flour|A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
170484|NCT01287403|E1|Reported Event|Refined Wheat Flour|A treated cereal flour mixed with milk (negative control).
170485|NCT01287364|B3|Baseline|Total|Total of all reporting groups
170486|NCT01287364|B2|Baseline|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
170487|NCT01287364|B1|Baseline|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
188757|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
170489|NCT01287364|P1|Participant Flow|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
170490|NCT01287364|O2|Outcome|Treatment Outcomes|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Outcomes Component reflects the perceived outcomes of drug treatment, including longer relief; symptom relief, if both were the same price; for feeling better about your appearance; for fewer problems with irritation to nose; faster relief; and how it makes your nose feel.
170491|NCT01287364|O1|Outcome|Treatment Process|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Process Component reflects preference on items pertaining to the perceived drug treatment process, including ease of use; convenience; flexibility in daily activities; taste; use in public; smell; fewer problems with medication running out of the nose; fewer problems with medication dripping down throat; and number of sprays per dose.
170492|NCT01287364|O3|Outcome|High Minus Low Response Group|Between Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170493|NCT01287364|O2|Outcome|High Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170494|NCT01287364|O1|Outcome|Low Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170495|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups..
170496|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups.
170497|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
170498|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
170499|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
170500|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
170501|NCT01287364|O3|Outcome|High Symptoms|Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170502|NCT01287364|O2|Outcome|Medium Symptoms|Patients were assigned to baseline rTNSS categories of Medium Symptoms (7.25 - 9.25; n = 61). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170503|NCT01287364|O1|Outcome|Low Symptoms|Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
170504|NCT01287364|O2|Outcome|Average Cronbach's Alpha (Standardized) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
170505|NCT01287364|O1|Outcome|Average Cronbach's Alpha (Raw) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
170506|NCT01287364|E2|Reported Event|Mometasone|mometasone nasal inhalation 200 μg once daily pooled
170507|NCT01287364|E1|Reported Event|Ciclesonide|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
170508|NCT01287221|B3|Baseline|Total|Total of all reporting groups
170509|NCT01287221|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170513|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170514|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170515|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170516|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170517|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170518|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170519|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170520|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170521|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170522|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170523|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170524|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170525|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170526|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170527|NCT01287221|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
170528|NCT01287221|E1|Reported Event|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
170529|NCT01287208|B3|Baseline|Total|Total of all reporting groups
170530|NCT01287208|B2|Baseline|Blinded|Activity monitor with no feedback
170531|NCT01287208|B1|Baseline|Unblinded|Activity monitor with visible and on-line feedback
170532|NCT01287208|P2|Participant Flow|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
170533|NCT01287208|P1|Participant Flow|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
170534|NCT01287208|O2|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
170535|NCT01287208|O1|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
170536|NCT01287208|E2|Reported Event|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
170537|NCT01287208|E1|Reported Event|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
170538|NCT01287117|B5|Baseline|Total|Total of all reporting groups
170539|NCT01287117|B4|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170540|NCT01287117|B3|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170541|NCT01287117|B2|Baseline|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170542|NCT01287117|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170543|NCT01287117|P4|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170544|NCT01287117|P3|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170545|NCT01287117|P2|Participant Flow|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170546|NCT01287117|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170547|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170548|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170549|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170550|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170551|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170552|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170553|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170554|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170555|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170556|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170557|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170915|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170558|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170559|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170560|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170561|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170562|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170563|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170564|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170565|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170566|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170567|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170568|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170569|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170570|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170571|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170572|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170573|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170574|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170575|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170576|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170577|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170578|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170579|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170580|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170581|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170582|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170583|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170584|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170585|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170586|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170587|NCT01287117|E4|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
170588|NCT01287117|E3|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
170589|NCT01287117|E2|Reported Event|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
170590|NCT01287117|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
170591|NCT01287065|B1|Baseline|Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM in 1 of 6 Seq|All participants received one of the following three treatments in one of three treatment periods from the Dry Powder Inhaler (DPI) for 14 days: placebo in the morning (AM) and evening (PM), Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM, and FF/VI inhalation powder 100/25 µg PM and placebo AM. Participants were randomized to receive treatment in one of the six following sequences (seq): (1) placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM; (2) placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM; (3) FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, placebo; (4) FF/VI 100/25 µg AM, placebo, FF/VI 100/25 µg PM; (5) FF/VI 100/25 µg PM, placebo, FF/VI 100/25 µg AM; (6) FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, placebo. Each 14 day treatment period was followed by a 14-21 day washout period.
170592|NCT01287065|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, Placebo|Participants received FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
170593|NCT01287065|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg PM, Placebo, FF/VI 100/25 µg AM|Participants received FF/VI 100/25 µg PM, placebo, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
170594|NCT01287065|P4|Participant Flow|Sequence 4: FF/VI 100/25 µg AM, Placebo, FF/VI 100/25 µg PM|Participants received FF/VI 100/25 µg AM, placebo, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
188758|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
170595|NCT01287065|P3|Participant Flow|Sequence 3: FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, Placebo|Participants received FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
170596|NCT01287065|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM|Participants received placebo, FF/VI 100/25 µg PM, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
170597|NCT01287065|P1|Participant Flow|Sequence 1: Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM|Participants received placebo, Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) AM, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
170598|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170599|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170600|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170601|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170602|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170603|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170604|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170605|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170606|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170607|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170608|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170609|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170610|NCT01287065|E3|Reported Event|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170611|NCT01287065|E2|Reported Event|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170612|NCT01287065|E1|Reported Event|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
170613|NCT01287039|B3|Baseline|Total|Total of all reporting groups
170614|NCT01287039|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170615|NCT01287039|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170616|NCT01287039|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170617|NCT01287039|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170618|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170619|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170620|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170621|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170622|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170623|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170624|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170625|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170626|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170627|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170628|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170629|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170630|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170631|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170632|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170633|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170634|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170635|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170636|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170637|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170638|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170639|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170640|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170641|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170642|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170643|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170644|NCT01287039|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170645|NCT01287039|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
170646|NCT01286818|B1|Baseline|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170647|NCT01286818|P1|Participant Flow|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170648|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170649|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170696|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170650|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170651|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170652|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170653|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170654|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170655|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170656|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170697|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170698|NCT01286753|O1|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170699|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170657|NCT01286818|E1|Reported Event|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
170658|NCT01286805|B3|Baseline|Total|Total of all reporting groups
170659|NCT01286805|B2|Baseline|Control Group|The control group received only a combined spinal-epidural.
170660|NCT01286805|B1|Baseline|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170661|NCT01286805|P2|Participant Flow|Control Group|The control group received only a combined spinal-epidural.
170662|NCT01286805|P1|Participant Flow|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170663|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170664|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170665|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170666|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170667|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170668|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170669|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170670|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170671|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170672|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170673|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170674|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170675|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170676|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170677|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
170678|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170679|NCT01286805|E2|Reported Event|Control Group|The control group received only a combined spinal-epidural.
170680|NCT01286805|E1|Reported Event|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
170681|NCT01286753|B3|Baseline|Total|Total of all reporting groups
170682|NCT01286753|B2|Baseline|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170683|NCT01286753|B1|Baseline|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170684|NCT01286753|P2|Participant Flow|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
170685|NCT01286753|P1|Participant Flow|Tyrosine Kinase Inhibitor (TKI) Naive|Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
170686|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170687|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170688|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170689|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170690|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170691|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170692|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170693|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170694|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170695|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
171012|NCT01285713|E2|Reported Event|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
170700|NCT01286753|E2|Reported Event|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
170701|NCT01286753|E1|Reported Event|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
170702|NCT01286740|B1|Baseline|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170703|NCT01286740|P1|Participant Flow|FTC/RPV/TDF|Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
170704|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170705|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170706|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170707|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170708|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170709|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170710|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170711|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170712|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170713|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170714|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170715|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170716|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170717|NCT01286740|E1|Reported Event|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
170718|NCT01286558|B3|Baseline|Total|Total of all reporting groups
170719|NCT01286558|B2|Baseline|40 mg Telmisartan and 5 mg Amlodipine FDC|
170720|NCT01286558|B1|Baseline|80 mg Telmisartan and 5 mg Amlodipine FDC|
170721|NCT01286558|P2|Participant Flow|40 mg Telmisartan and 5 mg Amlodipine FDC|
170722|NCT01286558|P1|Participant Flow|80 mg Telmisartan and 5 mg Amlodipine FDC|
170723|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170724|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170725|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170726|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170727|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170728|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170729|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170730|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170731|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170732|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170733|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170734|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170735|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170736|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170737|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170738|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170739|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170740|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170741|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170742|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170743|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170744|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170745|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170746|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170747|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
170748|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
170749|NCT01286558|E2|Reported Event|40 mg Telmisartan and 5 mg Amlodipine FDC|
170750|NCT01286558|E1|Reported Event|80 mg Telmisartan and 5 mg Amlodipine FDC|
170751|NCT01286493|B1|Baseline|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
170752|NCT01286493|P1|Participant Flow|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
170753|NCT01286493|O1|Outcome|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
170754|NCT01286493|E1|Reported Event|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
171013|NCT01285713|E1|Reported Event|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
170755|NCT01286454|B1|Baseline|Entire Study Population|Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
170756|NCT01286454|P11|Participant Flow|Fesoterodine 4 mg 10% ER Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
170757|NCT01286454|P10|Participant Flow|Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170758|NCT01286454|P9|Participant Flow|Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170759|NCT01286454|P8|Participant Flow|Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170760|NCT01286454|P7|Participant Flow|Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170761|NCT01286454|P6|Participant Flow|Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170762|NCT01286454|P5|Participant Flow|Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170763|NCT01286454|P4|Participant Flow|Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170764|NCT01286454|P3|Participant Flow|Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170765|NCT01286454|P2|Participant Flow|Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170800|NCT01286454|E3|Reported Event|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170801|NCT01286454|E2|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170802|NCT01286454|E1|Reported Event|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170766|NCT01286454|P1|Participant Flow|Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER|Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
170767|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170768|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170769|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170770|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170771|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170772|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170773|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170774|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170775|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170776|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170777|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170778|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170779|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170780|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170781|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170782|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170783|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170784|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170785|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170786|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170787|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170788|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170789|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170790|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170791|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170792|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170793|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170794|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170795|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170796|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
170797|NCT01286454|E6|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
170798|NCT01286454|E5|Reported Event|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
170799|NCT01286454|E4|Reported Event|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
170804|NCT01286402|B2|Baseline|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170805|NCT01286402|B1|Baseline|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170806|NCT01286402|P2|Participant Flow|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170807|NCT01286402|P1|Participant Flow|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170808|NCT01286402|O2|Outcome|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170809|NCT01286402|O1|Outcome|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170810|NCT01286402|E2|Reported Event|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170811|NCT01286402|E1|Reported Event|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
170812|NCT01286324|B3|Baseline|Total|Total of all reporting groups
170813|NCT01286324|B2|Baseline|Placebo Tablet|Contained lactose
170814|NCT01286324|B1|Baseline|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
170815|NCT01286324|P2|Participant Flow|Placebo Tablet|Contained lactose
170816|NCT01286324|P1|Participant Flow|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
170817|NCT01286324|O2|Outcome|Placebo Tablet|Contained lactose
170818|NCT01286324|O1|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
170819|NCT01286324|E2|Reported Event|Placebo Tablet|Contained lactose
170820|NCT01286324|E1|Reported Event|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
170821|NCT01286311|B3|Baseline|Total|Total of all reporting groups
170822|NCT01286311|B2|Baseline|Control|
170823|NCT01286311|B1|Baseline|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170824|NCT01286311|P2|Participant Flow|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
170825|NCT01286311|P1|Participant Flow|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170826|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170827|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170828|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170829|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170830|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170831|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170832|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170833|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170834|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170835|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170836|NCT01286311|E2|Reported Event|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
170837|NCT01286311|E1|Reported Event|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
170838|NCT01286207|B4|Baseline|Total|Total of all reporting groups
170840|NCT01286207|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170841|NCT01286207|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170842|NCT01286207|P3|Participant Flow|Standard Care|Standard care at onset of migraine attack
170843|NCT01286207|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170844|NCT01286207|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170845|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
170846|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170847|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170848|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
170849|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170850|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170851|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
170852|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170853|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170854|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
170855|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170856|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170857|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
170858|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170859|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170860|NCT01286207|E3|Reported Event|Standard Care|Standard care at onset of migraine attack
170861|NCT01286207|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170862|NCT01286207|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
170863|NCT01286168|B1|Baseline|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170864|NCT01286168|P1|Participant Flow|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170865|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170866|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170867|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170868|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170869|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170870|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170871|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170914|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170872|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
170873|NCT01286168|E2|Reported Event|Control Side|"Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.~Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care."
170874|NCT01286168|E1|Reported Event|Antisepsis Side|"A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.~Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day~Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days~Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days."
170875|NCT01286129|B3|Baseline|Total|Total of all reporting groups
170876|NCT01286129|B2|Baseline|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170877|NCT01286129|B1|Baseline|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170878|NCT01286129|P2|Participant Flow|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170879|NCT01286129|P1|Participant Flow|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170880|NCT01286129|O2|Outcome|Allergic Non Asthmatic|Change in nasal lavage eosinophil percentages in allergic non asthmatic at baseline and at 7h post first and last challenge
170881|NCT01286129|O1|Outcome|Allergic Asthmatic|Change in nasal lavage eosinophil percentages in allergic asthmatic at baseline and at 7h post first and last challenge
170882|NCT01286129|O2|Outcome|Allergic Rhinitic Without Asthma|Variation in sputum eosinophil percentage in allergic non asthmatic between baseline value and at 7h following first and last challenge
170883|NCT01286129|O1|Outcome|Allergic Asthmatic|Variation in sputum eosinophil percentage in allergic asthmatic between baseline value and at 7h following first and last challenge
170884|NCT01286129|E2|Reported Event|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170885|NCT01286129|E1|Reported Event|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
170886|NCT01286077|B3|Baseline|Total|Total of all reporting groups
170887|NCT01286077|B2|Baseline|Non-treated Control|no treatment, observation only
170888|NCT01286077|B1|Baseline|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170889|NCT01286077|P2|Participant Flow|Non-treated Control|no treatment, observation only
170890|NCT01286077|P1|Participant Flow|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170891|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170892|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170893|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170894|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170895|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170896|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170897|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170898|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170899|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170900|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170901|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170902|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170903|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170904|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170905|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170906|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170907|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170908|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170909|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170910|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170911|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170912|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170913|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170916|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170917|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170918|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170919|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
170920|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170921|NCT01286077|E2|Reported Event|Non-treated Control|no treatment, observation only
170922|NCT01286077|E1|Reported Event|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
170923|NCT01286012|B3|Baseline|Total|Total of all reporting groups
170924|NCT01286012|B2|Baseline|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
170925|NCT01286012|B1|Baseline|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
170926|NCT01286012|P2|Participant Flow|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
170927|NCT01286012|P1|Participant Flow|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
170928|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
170929|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
170930|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
170931|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
170932|NCT01286012|E2|Reported Event|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
170933|NCT01286012|E1|Reported Event|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
170934|NCT01285947|B3|Baseline|Total|Total of all reporting groups
170935|NCT01285947|B2|Baseline|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
170936|NCT01285947|B1|Baseline|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
170937|NCT01285947|P2|Participant Flow|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
170938|NCT01285947|P1|Participant Flow|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
170939|NCT01285947|O2|Outcome|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
170940|NCT01285947|O1|Outcome|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
170941|NCT01285947|E2|Reported Event|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
170942|NCT01285947|E1|Reported Event|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
170943|NCT01285908|B1|Baseline|All Study Participants|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
170944|NCT01285908|P3|Participant Flow|Norepinephrine, Then Saline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
170945|NCT01285908|P2|Participant Flow|Saline, Then Norepinephrine|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
170946|NCT01285908|P1|Participant Flow|Baseline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
170947|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a norepinephrine infusion.
170948|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a saline infusion.
170949|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of plasma levels of dihydroxyphenylglycol at varying tilt angles.
170950|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a norepinephrine infusion.
170951|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a saline infusion.
170952|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of plasma levels of norepinephrine at varying tilt angles.
170953|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a norepinephrine infusion.
170954|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a saline infusion.
170955|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of total peripheral resistance taken at varying tilt angles.
170956|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a norepinephrine infusion.
170957|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a saline infusion.
170958|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac output taken at varying tilt angles.
170959|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a norepinephrine infusion.
170960|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a saline infusion.
170961|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of average blood pressure taken at varying tilt angles.
170962|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a norepinephrine infusion.
170963|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a saline infusion.
170964|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac stroke volume taken at varying tilt angles.
170965|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a norepinephrine infusion.
170966|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a saline infusion.
170967|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of heart rate taken at varying tilt angles.
170968|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
170969|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
170970|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of diastolic blood pressure taken at varying tilt angles.
170971|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
170972|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
170973|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
170974|NCT01285908|E3|Reported Event|Norepinephrine, Then Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
170975|NCT01285908|E2|Reported Event|Saline, Then Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
170976|NCT01285908|E1|Reported Event|Baseline|The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
170977|NCT01285843|B3|Baseline|Total|Total of all reporting groups
170978|NCT01285843|B2|Baseline|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170979|NCT01285843|B1|Baseline|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170980|NCT01285843|P2|Participant Flow|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170981|NCT01285843|P1|Participant Flow|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170982|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170983|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170984|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170985|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170986|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170987|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170988|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170989|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170990|NCT01285843|E2|Reported Event|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
170991|NCT01285843|E1|Reported Event|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
170992|NCT01285791|B4|Baseline|Total|Total of all reporting groups
170993|NCT01285791|B3|Baseline|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
170994|NCT01285791|B2|Baseline|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
170995|NCT01285791|B1|Baseline|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
170996|NCT01285791|P3|Participant Flow|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
170997|NCT01285791|P2|Participant Flow|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
170998|NCT01285791|P1|Participant Flow|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
170999|NCT01285791|O3|Outcome|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
171000|NCT01285791|O2|Outcome|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
171001|NCT01285791|O1|Outcome|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
171002|NCT01285791|E3|Reported Event|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
171003|NCT01285791|E2|Reported Event|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
171004|NCT01285791|E1|Reported Event|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
171005|NCT01285713|B3|Baseline|Total|Total of all reporting groups
171006|NCT01285713|B2|Baseline|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
171007|NCT01285713|B1|Baseline|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
171008|NCT01285713|P2|Participant Flow|Normal Saline (NS)|10cc/kg NS, followed by 30cc/kg NS
171009|NCT01285713|P1|Participant Flow|5% Dextrose (D5) in Normal Saline (NS)|10cc/kg D5NS, followed by 30cc/kg NS
171010|NCT01285713|O2|Outcome|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
171011|NCT01285713|O1|Outcome|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
171015|NCT01285635|B3|Baseline|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171016|NCT01285635|B2|Baseline|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
171017|NCT01285635|B1|Baseline|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171018|NCT01285635|P3|Participant Flow|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171019|NCT01285635|P2|Participant Flow|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171020|NCT01285635|P1|Participant Flow|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171021|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171022|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171023|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171024|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171025|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171026|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171027|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171028|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
171029|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171030|NCT01285635|O1|Outcome|Docetaxel and AT-101|"Patients all receive Docetaxel 75mg/m^2 on Day 1. Patients will receive AT-101 on one of the following arms:~Arm A: Docetaxel alone for two weeks, then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.~Arm B: AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles~Arm C: AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles."
171031|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171032|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171033|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171034|NCT01285635|E3|Reported Event|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171035|NCT01285635|E2|Reported Event|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171036|NCT01285635|E1|Reported Event|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
171037|NCT01285609|B3|Baseline|Total|Total of all reporting groups
171038|NCT01285609|B2|Baseline|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171039|NCT01285609|B1|Baseline|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171040|NCT01285609|P2|Participant Flow|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171041|NCT01285609|P1|Participant Flow|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171067|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171042|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171043|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171044|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171045|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171046|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171047|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171048|NCT01285609|E2|Reported Event|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171049|NCT01285609|E1|Reported Event|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
171050|NCT01285518|B9|Baseline|Total|Total of all reporting groups
171051|NCT01285518|B8|Baseline|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171052|NCT01285518|B7|Baseline|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171053|NCT01285518|B6|Baseline|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171054|NCT01285518|B5|Baseline|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171055|NCT01285518|B4|Baseline|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171056|NCT01285518|B3|Baseline|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171057|NCT01285518|B2|Baseline|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171058|NCT01285518|B1|Baseline|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171059|NCT01285518|P8|Participant Flow|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171060|NCT01285518|P7|Participant Flow|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171061|NCT01285518|P6|Participant Flow|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171062|NCT01285518|P5|Participant Flow|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171063|NCT01285518|P4|Participant Flow|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171064|NCT01285518|P3|Participant Flow|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171065|NCT01285518|P2|Participant Flow|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171066|NCT01285518|P1|Participant Flow|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171068|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171069|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171070|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171071|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171072|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171073|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171074|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171075|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171076|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171077|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171078|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171079|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171080|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171081|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171082|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171083|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171084|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171085|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171086|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171087|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171088|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171089|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171090|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171091|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171092|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171093|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171094|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171095|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171096|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171097|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171098|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171099|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171100|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171101|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171102|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171103|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171104|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171105|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171106|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171107|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171108|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171109|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171110|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171111|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171112|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171113|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171114|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171115|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171116|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171696|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
171117|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171118|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171119|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171120|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171121|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171122|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171123|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171124|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171125|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171126|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171127|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171128|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171129|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171130|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171131|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171132|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171133|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171134|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171135|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171136|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171137|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171138|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171139|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171140|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171141|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171142|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171143|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171144|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171145|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171146|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171147|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171148|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171149|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171150|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171151|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171152|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171153|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171154|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171155|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171156|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171157|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171158|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171159|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171160|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171161|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171162|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171163|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171164|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
172176|NCT01283516|P9|Participant Flow|750 mg|Participants receiving 750 mg of LDK378
171165|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171166|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171167|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171168|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171169|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171170|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171171|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171172|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171173|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171174|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171175|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171176|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171177|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171178|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171179|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171180|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171181|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171182|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171183|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171184|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171185|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171186|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171187|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171188|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171189|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171190|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171191|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171192|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171193|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171194|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171195|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171196|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171197|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171198|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171199|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171200|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171201|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171202|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171203|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171204|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171205|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171206|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171207|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171208|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171209|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171210|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171211|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171212|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
188759|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
171213|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171214|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171215|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171216|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171217|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171218|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171219|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171220|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171221|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171222|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171223|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171224|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171225|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171226|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171227|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171228|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171229|NCT01285518|O1|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171230|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171231|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171232|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171233|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171234|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171235|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171236|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171237|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171238|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171239|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171240|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171241|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171242|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171243|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171244|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171245|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171246|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171247|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171248|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171249|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171250|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171251|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171252|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171253|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171254|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171255|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171256|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171257|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171258|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171259|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171260|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
172177|NCT01283516|P8|Participant Flow|700 mg|Participants receiving 700 mg of LDK378
171261|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171262|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171263|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171264|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171265|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171266|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171267|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171268|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171269|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171270|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171271|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171272|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171273|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171274|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171275|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171276|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171277|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171278|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171279|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171280|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171281|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171282|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171283|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171284|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171285|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171286|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171287|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171288|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171289|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171290|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171291|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171292|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171293|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171294|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171295|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171296|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171297|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171298|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171299|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171300|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171301|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171302|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171303|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171304|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171305|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171306|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171307|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171308|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
188760|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
171309|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171310|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171311|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171312|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171313|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171314|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171315|NCT01285518|E8|Reported Event|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
171316|NCT01285518|E7|Reported Event|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
171317|NCT01285518|E6|Reported Event|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
171318|NCT01285518|E5|Reported Event|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
171319|NCT01285518|E4|Reported Event|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
171320|NCT01285518|E3|Reported Event|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
171321|NCT01285518|E2|Reported Event|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
171322|NCT01285518|E1|Reported Event|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
171323|NCT01285492|B3|Baseline|Total|Total of all reporting groups
171324|NCT01285492|B2|Baseline|Tiotropium|tiotropium 18 μg o.d.
171325|NCT01285492|B1|Baseline|QVA149|QVA149 110/50 μg once a day (o.d)
171326|NCT01285492|P2|Participant Flow|Tiotropium|tiotropium 18 μg o.d.
171327|NCT01285492|P1|Participant Flow|QVA149|QVA149 110/50 μg o.d. (once a day)
171328|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171329|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171330|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171331|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171332|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171333|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171334|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171335|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171336|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171337|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171338|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171339|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171340|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
171341|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
171342|NCT01285492|E2|Reported Event|Tiotropium|tiotropium 18 μg o.d.
171343|NCT01285492|E1|Reported Event|QVA149|QVA149 110/50 μg once a day (o.d)
171344|NCT01285427|B1|Baseline|DNA Loci (SeCore vs. SSP UniTray Platforms)|
171345|NCT01285427|P1|Participant Flow|DNA Loci (SeCore vs. SSP UniTray Platforms)|
171346|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB345 Loci)|SeCore® Kit, DR Group Kit (DRB345 Loci),
171347|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB1 Locus)|SeCore® Kit, DR Group Kit (DRB1 Locus),
171348|NCT01285427|O1|Outcome|SeCore® Kit, DRB1 Locus|SeCore® Kit, DRB1 Locus
171349|NCT01285427|O1|Outcome|SeCore® Kit, DQB1 Locus|SeCore® Kit, DQB1 Locus
171350|NCT01285427|O1|Outcome|SeCore® DPB1 Locus Kit|SeCore® DPB1 Locus Kit
171351|NCT01285427|O1|Outcome|SeCore® Kit, C Locus|SeCore® Kit, C Locus
171352|NCT01285427|O1|Outcome|SeCore® Kit, B Locus (Single Amp)|SeCore® Kit, B Locus (Single Amp)
171353|NCT01285427|O1|Outcome|Concordance|SeCore kit, A Locus
171354|NCT01285427|O1|Outcome|Concordance|All SeCore Kits
171355|NCT01285427|E1|Reported Event|Concordance|All SeCore Kits
171356|NCT01285401|B3|Baseline|Total|Total of all reporting groups
171357|NCT01285401|B2|Baseline|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171358|NCT01285401|B1|Baseline|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171359|NCT01285401|P2|Participant Flow|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171360|NCT01285401|P1|Participant Flow|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
171361|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171362|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171363|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171457|NCT01285310|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
188761|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
171364|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171365|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171366|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171367|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171368|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171369|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171370|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171371|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171372|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171373|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171374|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171375|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171376|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171377|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171378|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171379|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171380|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171381|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171382|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171383|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171384|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171385|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171386|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171387|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171388|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171389|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171390|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171391|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171458|NCT01285310|O1|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171392|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171393|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171394|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171395|NCT01285401|E2|Reported Event|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
171396|NCT01285401|E1|Reported Event|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
171397|NCT01285323|B3|Baseline|Total|Total of all reporting groups
171398|NCT01285323|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171399|NCT01285323|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171400|NCT01285323|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171401|NCT01285323|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171402|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171403|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171404|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171405|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171406|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171407|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171408|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171409|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171410|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171411|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171412|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171413|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171414|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171415|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171416|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171417|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171418|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171419|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171420|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171421|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171422|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171423|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171424|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171425|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171426|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171427|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171428|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171429|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171430|NCT01285323|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171431|NCT01285323|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
171432|NCT01285310|B4|Baseline|Total|Total of all reporting groups
171433|NCT01285310|B3|Baseline|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171434|NCT01285310|B2|Baseline|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171435|NCT01285310|B1|Baseline|Placebo|Placebo: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders were transitioned early to 20 mg Apremilast BID at Week 16.
171436|NCT01285310|P5|Participant Flow|Placebo / Apremilast 20 mg XO|"Participants initially randomized to receive placebo twice daily who were transitioned at Week 24 (XO) to receive 20 mg apremilast for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
171437|NCT01285310|P4|Participant Flow|Placebo/Apremilast 20mg EE|"Participants initially randomized to receive placebo twice daily and were transitioned due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to week 24.~At week 24, participants were continued on Apremilast 20 mg BID for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
171438|NCT01285310|P3|Participant Flow|Apremilast 30 mg|"Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
171439|NCT01285310|P2|Participant Flow|Apremilast 20 mg|"Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
171440|NCT01285310|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg Apremilast twice daily (early escape), and were designated as Placebo/Apremilast 20mg EE.
171441|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171442|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171443|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171444|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171445|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171446|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171447|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171448|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171449|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171450|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171451|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171452|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171453|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171454|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171455|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171456|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171459|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171460|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171461|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171462|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171463|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171464|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171465|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171466|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
171467|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171468|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171469|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171470|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171471|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171472|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171473|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171474|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171475|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171476|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171477|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171478|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171479|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171480|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171481|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|.Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171482|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171483|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171484|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171485|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily
171486|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171487|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171488|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171489|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171490|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171491|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171492|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171493|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171494|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171495|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171496|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171497|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171498|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171499|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171500|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171501|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171502|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171503|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171504|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171505|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171506|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171507|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171508|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171509|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171510|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171511|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171512|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171513|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171514|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171515|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171516|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171517|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171518|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171519|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171520|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171521|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171522|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171523|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171524|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171525|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171526|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171527|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171528|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171529|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171530|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171531|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171532|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171533|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171534|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171535|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171536|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171537|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171538|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171539|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171540|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171541|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned transitioned to receive 20 mg apremilast twice daily.
171542|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171543|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171544|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171545|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
171546|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
171547|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171548|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171549|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171550|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171551|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171552|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171553|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171554|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171555|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171556|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171557|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171558|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171559|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171560|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171561|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171562|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171563|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171564|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171565|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171566|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171567|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape)and were designated as Placebo/Apremilast 20mg EE.
171568|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171569|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171570|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171571|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171572|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171573|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171574|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171575|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171615|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
188762|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
171576|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171577|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171578|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171579|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171580|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171581|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171582|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171583|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171584|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171585|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE .
171586|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171587|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171588|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171589|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171590|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171591|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171592|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171593|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171594|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE ..
171595|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171596|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171597|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171598|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily
171599|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171600|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171601|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171602|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily
171603|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape).
171604|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171605|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171606|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171607|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171608|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171609|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171610|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171611|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171612|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171613|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171614|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
188763|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
171616|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171617|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171618|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily
171619|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171620|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171621|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171622|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171623|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171624|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171625|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171626|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171627|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171628|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171629|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171630|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171631|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171632|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171633|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171634|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171635|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171636|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171637|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171638|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171639|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171640|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171641|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171642|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171643|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
171644|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171645|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171646|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171647|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171648|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171649|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171650|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171651|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171652|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171653|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171654|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171655|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171656|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171657|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE
171658|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
171659|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
171660|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
171661|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171662|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171663|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171664|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
171665|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
171666|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
171667|NCT01285310|E5|Reported Event|Study Termination: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
171668|NCT01285310|E4|Reported Event|Study Termination: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
171669|NCT01285310|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
171670|NCT01285310|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
171671|NCT01285310|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
171672|NCT01285076|B1|Baseline|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171673|NCT01285076|P1|Participant Flow|All Enrolled Participants|Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171674|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171675|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171676|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171677|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171678|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171679|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171680|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171681|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171682|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171683|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171684|NCT01285076|E1|Reported Event|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
171685|NCT01285050|B1|Baseline|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
171686|NCT01285050|P1|Participant Flow|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
171687|NCT01285050|O2|Outcome|Post ART HCV Decline|HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
171688|NCT01285050|O1|Outcome|Pre ART HCV RNA Decline|"HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)~Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.~ART included:~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
171689|NCT01285050|E1|Reported Event|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
171690|NCT01285024|B3|Baseline|Total|Total of all reporting groups
171691|NCT01285024|B2|Baseline|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
171692|NCT01285024|B1|Baseline|Control|No Vitagel used during total hip arthroplasty
171693|NCT01285024|P2|Participant Flow|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
171694|NCT01285024|P1|Participant Flow|Control|No Vitagel used during total hip arthroplasty
171695|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
171697|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
171698|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
171699|NCT01285024|E2|Reported Event|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
171700|NCT01285024|E1|Reported Event|Control|No Vitagel used during total hip arthroplasty
171701|NCT01284959|B4|Baseline|Total|Total of all reporting groups
171702|NCT01284959|B3|Baseline|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171703|NCT01284959|B2|Baseline|Placebo|drug: lactose group: placebo
171704|NCT01284959|B1|Baseline|Risperidone|Drug: risperidone Groups: risperidone
171705|NCT01284959|P3|Participant Flow|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171706|NCT01284959|P2|Participant Flow|Placebo|drug: lactose group: placebo
171707|NCT01284959|P1|Participant Flow|Risperidone|Drug: risperidone Groups: risperidone
171708|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171709|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171710|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171711|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171712|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171713|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171714|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171715|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171716|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171717|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171718|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171719|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171720|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171721|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171722|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171723|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171724|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171725|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171726|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171727|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
171728|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
171729|NCT01284959|E3|Reported Event|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
171730|NCT01284959|E2|Reported Event|Placebo|drug: lactose group: placebo
171731|NCT01284959|E1|Reported Event|Risperidone|Drug: risperidone Groups: risperidone
171732|NCT01284634|B5|Baseline|Total|Total of all reporting groups
171733|NCT01284634|B4|Baseline|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171734|NCT01284634|B3|Baseline|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
171735|NCT01284634|B2|Baseline|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
171736|NCT01284634|B1|Baseline|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
171737|NCT01284634|P4|Participant Flow|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171738|NCT01284634|P3|Participant Flow|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171739|NCT01284634|P2|Participant Flow|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171740|NCT01284634|P1|Participant Flow|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171741|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171742|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171907|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
188764|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
171743|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171744|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171745|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171746|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171747|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171748|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171749|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171750|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171751|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171752|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171753|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171754|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171755|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171756|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171757|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171758|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171759|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171760|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171761|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171762|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171763|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171764|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171908|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
188765|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
171765|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171766|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171767|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171768|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171769|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171770|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171771|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171772|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171773|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171774|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171775|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171776|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171777|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171778|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171779|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171780|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171781|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171782|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171783|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171784|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171785|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171786|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171958|NCT01284426|O1|Outcome|Chronic Urticaria|Chronic urticaria, Natural history
171787|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171788|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171789|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171790|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171791|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171792|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171793|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171794|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171795|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171796|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171797|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171798|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171799|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171800|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171801|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171802|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171803|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171804|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171805|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171806|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171807|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171808|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171959|NCT01284426|E1|Reported Event|Chronic Urticaria|Chronic urticaria, Natural history
172178|NCT01283516|P7|Participant Flow|600 mg|Participants receiving 600 mg of LDK378
171809|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171810|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171811|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171812|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171813|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171814|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171815|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171816|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171817|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171818|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171819|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171820|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171821|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171822|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171823|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171824|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171825|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171826|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171827|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171828|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171829|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171830|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
172179|NCT01283516|P6|Participant Flow|500 mg|Participants receiving 500 mg of LDK378
171831|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171832|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171833|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171834|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171835|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171836|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171837|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171838|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171839|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171840|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171841|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171842|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171843|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171844|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171845|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171846|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171847|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171848|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171849|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171850|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171851|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 .
171852|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171960|NCT01284361|B1|Baseline|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
171853|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171854|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171855|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171856|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171857|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171858|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171859|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171860|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171861|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171862|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171863|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171864|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171865|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171866|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
171867|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171868|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171869|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171870|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 .
171871|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171872|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171873|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171874|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
172119|NCT01283581|E3|Reported Event|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
171875|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
171876|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
171877|NCT01284634|E4|Reported Event|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
171878|NCT01284634|E3|Reported Event|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
171879|NCT01284634|E2|Reported Event|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
171880|NCT01284634|E1|Reported Event|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
171881|NCT01284621|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril~Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments."
171882|NCT01284621|P6|Participant Flow|Empa + Ramipril / Ramipril Alone / Empa Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Ramipril~Empagliflozin alone"
171883|NCT01284621|P5|Participant Flow|Empa + Ramipril / Empa Alone / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Empagliflozin alone~Ramipril"
171884|NCT01284621|P4|Participant Flow|Ramipril Alone / Empa + Ramipril / Empa Alone|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin plus Ramipril~Empagliflozin alone"
171885|NCT01284621|P3|Participant Flow|Ramipril Alone / Empa Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin alone~Empagliflozin plus Ramipril"
171886|NCT01284621|P2|Participant Flow|Empa Alone / Ramipril Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril"
171887|NCT01284621|P1|Participant Flow|Empa Alone / Empa + Ramipril / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin alone~Empagliflozin plus Ramipril~Ramipril"
171888|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171889|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171890|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171891|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171892|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171893|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171894|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171895|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171896|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171897|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171898|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171899|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171900|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171901|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171902|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171903|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171904|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171905|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171906|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
172120|NCT01283581|E2|Reported Event|Linezolid|Linezolid 600 mg, BID
171909|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171910|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171911|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171912|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171913|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171914|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171915|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171916|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171917|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171918|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171919|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171920|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171921|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171922|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171923|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171924|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171925|NCT01284621|E3|Reported Event|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171926|NCT01284621|E2|Reported Event|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
171927|NCT01284621|E1|Reported Event|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
171928|NCT01284517|B3|Baseline|Total|Total of all reporting groups
171929|NCT01284517|B2|Baseline|Placebo + Li/VPA|
171930|NCT01284517|B1|Baseline|Lurasidone 20-120 mg Flexible Dose+Li/VPA|
171931|NCT01284517|P2|Participant Flow|Placebo + Li/VPA|Placebo + Lithium/divalproex
171932|NCT01284517|P1|Participant Flow|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
171933|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
171934|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
171935|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
171936|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
171937|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
171938|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
171939|NCT01284517|E2|Reported Event|Placebo + Li/VPA|Placebo (PO)+ Lithium/divalproex
171940|NCT01284517|E1|Reported Event|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
171941|NCT01284504|B3|Baseline|Total|Total of all reporting groups
171942|NCT01284504|B2|Baseline|Placebo|"placebo, tab~placebo: Placebo, tab"
171943|NCT01284504|B1|Baseline|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
171944|NCT01284504|P2|Participant Flow|Placebo|"placebo~placebo"
171945|NCT01284504|P1|Participant Flow|Celocoxib|Celecoxib: 200 mg tablet oral
171946|NCT01284504|O2|Outcome|Placebo|"placebo~placebo"
171947|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
171948|NCT01284504|E2|Reported Event|Placebo|"placebo, tab~placebo: Placebo, tab"
171949|NCT01284504|E1|Reported Event|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
171950|NCT01284491|B1|Baseline|Total Study Population|
171951|NCT01284491|P1|Participant Flow|Total Study Population|
171952|NCT01284491|O2|Outcome|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
171953|NCT01284491|O1|Outcome|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
171954|NCT01284491|E2|Reported Event|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
171955|NCT01284491|E1|Reported Event|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
171956|NCT01284426|B1|Baseline|Chronic Urticaria|Chronic urticaria, Natural history
171957|NCT01284426|P1|Participant Flow|Chronic Urticaria|Chronic urticaria, Natural history
171961|NCT01284361|P1|Participant Flow|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
171962|NCT01284361|O2|Outcome|Test 30 cm Catheter|Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
171963|NCT01284361|O1|Outcome|Control 40 cm Catheter|Commercial gel lubricated 40 cm catheter
171964|NCT01284361|O1|Outcome|Control and Test Crossover|Control and test intermittent urinary catheters : randomized cross-over
171965|NCT01284361|E2|Reported Event|Test 30 cm Catheter|Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
171966|NCT01284361|E1|Reported Event|Control 40 cm Catheter|Commercial 40 cm gel lubricated catheter
171967|NCT01284296|B1|Baseline|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
171968|NCT01284296|P1|Participant Flow|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
171969|NCT01284296|O2|Outcome|Digital Block (Perfusion Indices >2.0)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index >2.0
171970|NCT01284296|O1|Outcome|Digital Block (All Perfusion Indices 0.29-8.3)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
171971|NCT01284296|E1|Reported Event|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
171972|NCT01284114|B1|Baseline|Aliskiren|
171973|NCT01284114|P1|Participant Flow|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
171974|NCT01284114|O1|Outcome|Aliskiren|
171975|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
171976|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
171977|NCT01284114|O1|Outcome|Aliskiren|
171978|NCT01284114|O1|Outcome|Aliskiren|
171979|NCT01284114|E1|Reported Event|Aliskiren|
171980|NCT01284062|B5|Baseline|Total|Total of all reporting groups
171981|NCT01284062|B4|Baseline|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171982|NCT01284062|B3|Baseline|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171983|NCT01284062|B2|Baseline|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171984|NCT01284062|B1|Baseline|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171985|NCT01284062|P4|Participant Flow|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171986|NCT01284062|P3|Participant Flow|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171987|NCT01284062|P2|Participant Flow|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171988|NCT01284062|P1|Participant Flow|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171989|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171990|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171991|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171992|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171993|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171994|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171995|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171996|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171997|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171998|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
171999|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172000|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172001|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172002|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172003|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172004|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172005|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172121|NCT01283581|E1|Reported Event|Delafloxacin IV|Delafloxacin 300 mg, BID
172006|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172007|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172008|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172009|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172010|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172011|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172012|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172013|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172014|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172015|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172016|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172017|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172018|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172019|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172020|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172021|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172022|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172023|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172024|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172025|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172026|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172027|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172028|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172029|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172030|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172031|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172032|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172033|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172034|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172035|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172036|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172037|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172038|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172039|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172040|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172041|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172042|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172043|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172044|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172045|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172046|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172047|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172048|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172049|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172180|NCT01283516|P5|Participant Flow|400 mg|Participants receiving 400 mg of LDK378
172050|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172051|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172052|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172053|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172054|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172055|NCT01284062|E4|Reported Event|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172056|NCT01284062|E3|Reported Event|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172057|NCT01284062|E2|Reported Event|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172058|NCT01284062|E1|Reported Event|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
172059|NCT01283971|B3|Baseline|Total|Total of all reporting groups
172060|NCT01283971|B2|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172061|NCT01283971|B1|Baseline|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172062|NCT01283971|P2|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172063|NCT01283971|P1|Participant Flow|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172064|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172065|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172066|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172067|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172068|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172069|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172070|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172071|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172072|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172073|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172074|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172075|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172076|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172077|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172078|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172079|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172080|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172081|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172122|NCT01283555|B1|Baseline|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172082|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172083|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172084|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172085|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172086|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172087|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172088|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172089|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172090|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172091|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172092|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172093|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172094|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172095|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172096|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172097|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172098|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172099|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172100|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172101|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172102|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172103|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172104|NCT01283971|E2|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172105|NCT01283971|E1|Reported Event|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
172106|NCT01283581|B4|Baseline|Total|Total of all reporting groups
172107|NCT01283581|B3|Baseline|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
172108|NCT01283581|B2|Baseline|Linezolid|Linezolid 600 mg, BID
172109|NCT01283581|B1|Baseline|Delafloxacin IV|Delafloxacin 300 mg, BID
172110|NCT01283581|P3|Participant Flow|Vancomycin IV|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
172111|NCT01283581|P2|Participant Flow|Linezolid IV|Linezolid 600 mg, BID
172112|NCT01283581|P1|Participant Flow|Delafloxacin IV|Delafloxacin 300 mg, BID
172113|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
172114|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
172115|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
172116|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
172117|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
172118|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
172123|NCT01283555|P2|Participant Flow|Prefilled Applicator First, Then User-filled|Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period)
172124|NCT01283555|P1|Participant Flow|User-Filled Applicator First, Then Prefilled|User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period)
172125|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172126|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172127|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172128|NCT01283555|O2|Outcome|Colposcopic Findings After 7 Days of Product Use|Number of colposcopic findings identified during colposcopy after one week of twice daily product use (data from both study arms are combined). Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
172129|NCT01283555|O1|Outcome|Baseline Colposcopic Findings|Number of colposcopic findings identified during baseline colposcopies for both study arms. Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
172130|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172131|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
172132|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172133|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172134|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172135|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172136|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172137|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172138|NCT01283555|O3|Outcome|Same|no preference between user-filled or prefilled applicator
172139|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172140|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172141|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172142|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172143|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172144|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172145|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172146|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172147|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172148|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172149|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172150|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172151|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172152|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172153|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172154|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172155|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172156|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172157|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172158|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172159|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172160|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172161|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172162|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172163|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172164|NCT01283555|E2|Reported Event|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
172165|NCT01283555|E1|Reported Event|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
172166|NCT01283516|B10|Baseline|Total|Total of all reporting groups
172167|NCT01283516|B9|Baseline|750 mg|Participants receiving 750 mg of LDK378
172168|NCT01283516|B8|Baseline|700 mg|Participants receiving 700 mg of LDK378
172169|NCT01283516|B7|Baseline|600 mg|Participants receiving 600 mg of LDK378
172170|NCT01283516|B6|Baseline|500 mg|Participants receiving 500 mg of LDK378
172171|NCT01283516|B5|Baseline|400 mg|Participants receiving 400 mg of LDK378
172172|NCT01283516|B4|Baseline|300 mg|Participants receiving 300 mg of LDK378
172173|NCT01283516|B3|Baseline|200 mg|Participants receiving 200 mg of LDK378
172174|NCT01283516|B2|Baseline|100 mg|Participants receiving 100 mg of LDK378
172175|NCT01283516|B1|Baseline|50 mg|Participants receiving 50 mg of LDK378
172181|NCT01283516|P4|Participant Flow|300 mg|Participants receiving 300 mg of LDK378
172182|NCT01283516|P3|Participant Flow|200 mg|Participants receiving 200 mg of LDK378
172183|NCT01283516|P2|Participant Flow|100 mg|Participants receiving 100 mg of LDK378
172184|NCT01283516|P1|Participant Flow|50 mg|Participants receiving 50 mg of LDK378
172185|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
172186|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
172187|NCT01283516|O9|Outcome|LDK378 750|Participants receiving 750 mg of LDK378.
172188|NCT01283516|O8|Outcome|LDK378 700 mg|Participants receiving 700 mg of LDK378
172189|NCT01283516|O7|Outcome|LDK378 600 mg|Participants receiving 600 mg of LDK378
172190|NCT01283516|O6|Outcome|LDK378 500 mg|Participants receiving 500 mg of LDK378
172191|NCT01283516|O5|Outcome|LDK378 400 mg|Participants receiving 400 mg of LDK378
172192|NCT01283516|O4|Outcome|LDK378 300 mg|Participants receiving 300 mg of LDK378
172193|NCT01283516|O3|Outcome|LDK378 200 mg|Participants receiving 200 mg of LDK378
172194|NCT01283516|O2|Outcome|LDK378 100 mg|Participants receiving 100 mg of LDK378
172195|NCT01283516|O1|Outcome|LDK378 50 mg|Participants receiving 50 mg of LDK378
172196|NCT01283516|E9|Reported Event|LDK378 750 mg|LDK378 750 mg
172197|NCT01283516|E8|Reported Event|LDK378 700 mg|LDK378 700 mg
172198|NCT01283516|E7|Reported Event|LDK378 600 mg|LDK378 600 mg
172199|NCT01283516|E6|Reported Event|LDK378 500 mg|LDK378 500 mg
172200|NCT01283516|E5|Reported Event|LDK378 400 mg|LDK378 400 mg
172201|NCT01283516|E4|Reported Event|LDK378 300 mg|LDK378 300 mg
172202|NCT01283516|E3|Reported Event|LDK378 200 mg|LDK378 200 mg
172203|NCT01283516|E2|Reported Event|LDK378 100 mg|LDK378 100 mg
172204|NCT01283516|E1|Reported Event|LDK378 50 mg|LDK378 50 mg
172205|NCT01283464|B3|Baseline|Total|Total of all reporting groups
172206|NCT01283464|B2|Baseline|Tretinoin|Tretinoin 0.02% cream
172207|NCT01283464|B1|Baseline|Retinol|Retinol 1.0% cream
172208|NCT01283464|P2|Participant Flow|Tretinoin|Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
172209|NCT01283464|P1|Participant Flow|Retinol|Retinol 1.0% cream to entire face daily or as tolerated for 6 months
172210|NCT01283464|O2|Outcome|Tretinoin|Tretinoin 0.02% cream
172211|NCT01283464|O1|Outcome|Retinol|Retinol 1.0% cream
172212|NCT01283464|E2|Reported Event|Tretinoin|Tretinoin 0.02% cream
172213|NCT01283464|E1|Reported Event|Retinol|Retinol 1.0% cream
172214|NCT01283334|B1|Baseline|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
172215|NCT01283334|P1|Participant Flow|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
172216|NCT01283334|O1|Outcome|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
172217|NCT01283334|O2|Outcome|Everolimus Dose Level -1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)
172218|NCT01283334|O1|Outcome|Everolimus Dose Level 1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)
172219|NCT01283334|E1|Reported Event|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
172220|NCT01283321|B3|Baseline|Total|Total of all reporting groups
172221|NCT01283321|B2|Baseline|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
172222|NCT01283321|B1|Baseline|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
172223|NCT01283321|P2|Participant Flow|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
172224|NCT01283321|P1|Participant Flow|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
172225|NCT01283321|O2|Outcome|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
172226|NCT01283321|O1|Outcome|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
172227|NCT01283321|E2|Reported Event|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
172228|NCT01283321|E1|Reported Event|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
172229|NCT01283282|B1|Baseline|All Subjects|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
172230|NCT01283282|P2|Participant Flow|Clopidogrel First/Then Placebo|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks then were switched to placebo PO qd therapy for an additional 6 weeks without any wash out period in between.
172351|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172231|NCT01283282|P1|Participant Flow|Placebo First/Then Clopidogrel|The subjects received placebo PO qd for the first 6 weeks then were switched to clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
172232|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172233|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172234|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172235|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172236|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172237|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172238|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172239|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172240|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172241|NCT01283282|O1|Outcome|Clopidogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172242|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172243|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172244|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
172245|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
172246|NCT01283282|E2|Reported Event|Placebo|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
172247|NCT01283282|E1|Reported Event|Clopidogrel|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
172248|NCT01283152|B3|Baseline|Total|Total of all reporting groups
172249|NCT01283152|B2|Baseline|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172250|NCT01283152|B1|Baseline|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172251|NCT01283152|P2|Participant Flow|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172252|NCT01283152|P1|Participant Flow|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172253|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172254|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172255|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172256|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172257|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172258|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172259|NCT01283152|E2|Reported Event|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
172260|NCT01283152|E1|Reported Event|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
172261|NCT01283139|B5|Baseline|Total|Total of all reporting groups
172262|NCT01283139|B4|Baseline|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172263|NCT01283139|B3|Baseline|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172264|NCT01283139|B2|Baseline|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172265|NCT01283139|B1|Baseline|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172266|NCT01283139|P4|Participant Flow|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172352|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172267|NCT01283139|P3|Participant Flow|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172268|NCT01283139|P2|Participant Flow|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172269|NCT01283139|P1|Participant Flow|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172270|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172271|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172272|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172273|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172274|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172275|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172276|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172277|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172278|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172279|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172280|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172281|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172282|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172283|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172284|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172285|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172286|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172287|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172288|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172289|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172290|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172291|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172292|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172293|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172828|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172294|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172295|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172296|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172297|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172298|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172299|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172300|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172301|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172302|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172303|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172304|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172305|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
172306|NCT01283139|E4|Reported Event|Sifalimumab 1200 mg|Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
172307|NCT01283139|E3|Reported Event|Sifalimumab 600 mg|Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).
172308|NCT01283139|E2|Reported Event|Sifalimumab 200 mg|Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).
172309|NCT01283139|E1|Reported Event|Placebo|Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).
172310|NCT01283035|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172311|NCT01283035|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172312|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172313|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172314|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172315|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172316|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172317|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172318|NCT01283035|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
172319|NCT01283022|B1|Baseline|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
172320|NCT01283022|P1|Participant Flow|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
172321|NCT01283022|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
172322|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
172323|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
172324|NCT01283022|E1|Reported Event|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
172325|NCT01282866|B1|Baseline|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172326|NCT01282866|P1|Participant Flow|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172327|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172328|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172329|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172330|NCT01282866|E1|Reported Event|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
172331|NCT01282814|B3|Baseline|Total|Total of all reporting groups
172332|NCT01282814|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172333|NCT01282814|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172334|NCT01282814|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172335|NCT01282814|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172336|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172337|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172338|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172339|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172340|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172341|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172342|NCT01282814|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172343|NCT01282814|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172344|NCT01282801|B3|Baseline|Total|Total of all reporting groups
172345|NCT01282801|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172346|NCT01282801|B1|Baseline|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172347|NCT01282801|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172348|NCT01282801|P1|Participant Flow|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172349|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172350|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172829|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172353|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172354|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172355|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172356|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172357|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172358|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172359|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
172360|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
172361|NCT01282801|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
172362|NCT01282801|E1|Reported Event|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
172363|NCT01282723|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172364|NCT01282723|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172365|NCT01282723|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172366|NCT01282723|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172367|NCT01282710|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172368|NCT01282710|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172369|NCT01282710|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172370|NCT01282710|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
172371|NCT01282424|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172372|NCT01282424|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172373|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172374|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172375|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172376|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172377|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172378|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172379|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172380|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172381|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172382|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172383|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172384|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172385|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172386|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172387|NCT01282424|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
172388|NCT01282372|B1|Baseline|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172389|NCT01282372|P1|Participant Flow|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172390|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172391|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172392|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172393|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172394|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
188766|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
172395|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172396|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
172397|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172398|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172399|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172400|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
172401|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172402|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172403|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172404|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
172405|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172406|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172407|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172408|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
172409|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172410|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172411|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172412|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
172413|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
172414|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
172415|NCT01282372|E1|Reported Event|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
172416|NCT01282294|B1|Baseline|ETN PROtect|"There is only 1 cohort in this case series.~ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating"
172417|NCT01282294|P1|Participant Flow|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172418|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172419|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172420|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172421|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172422|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172423|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172424|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172425|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172426|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172427|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172428|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172429|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172430|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172431|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172432|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172433|NCT01282294|E1|Reported Event|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
172434|NCT01282229|B1|Baseline|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
172486|NCT01282138|B1|Baseline|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172435|NCT01282229|P1|Participant Flow|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
172436|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
172437|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
172438|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
172439|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172440|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
172441|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
172442|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
172443|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172444|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
172445|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
172446|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
172447|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172448|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
172449|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
172450|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
172451|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172452|NCT01282229|O8|Outcome|Coronal Debridement (≥7mm Pockets)|Quadrant treated with coronal debridement
172453|NCT01282229|O7|Outcome|Coronal Debridement (5-6mm Pockets)|Quadrant treated with coronal debridement
172454|NCT01282229|O6|Outcome|Scaling and Root Planing (≥7mm Pockets)|Quadrant treated with scaling and root planing alone
172455|NCT01282229|O5|Outcome|Scaling and Root Planing (5-6mm Pockets)|Quadrant treated with scaling and root planing alone
172456|NCT01282229|O4|Outcome|Modified Widman Flap (≥7mm Pockets)|Quadrant treated with Modified Widman Flap surgery
172457|NCT01282229|O3|Outcome|Modified Widman Flap (5-6mm Pockets)|Quadrant treated with Modified Widman Flap surgery
172458|NCT01282229|O2|Outcome|LANAP Quadrant (≥7mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172459|NCT01282229|O1|Outcome|LANAP Quadrant (5-6mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172460|NCT01282229|E4|Reported Event|Coronal Debridement|Quadrant treated with coronal debridement
172461|NCT01282229|E3|Reported Event|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
172462|NCT01282229|E2|Reported Event|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
172463|NCT01282229|E1|Reported Event|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
172464|NCT01282203|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172465|NCT01282203|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172466|NCT01282203|O3|Outcome|Anesthesia With Sevorane|Duration of experience with Sevorane.
172467|NCT01282203|O2|Outcome|Inhalation Anesthesia|Duration of experience with inhalation anesthesia.
172468|NCT01282203|O1|Outcome|General Anesthesia|Duration of experience with general anesthesia.
172469|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172470|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172471|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172472|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172473|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172474|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172475|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172476|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172477|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172478|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172479|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172480|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172481|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172482|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172483|NCT01282203|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172484|NCT01282138|B3|Baseline|Total|Total of all reporting groups
172485|NCT01282138|B2|Baseline|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172830|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172487|NCT01282138|P2|Participant Flow|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172488|NCT01282138|P1|Participant Flow|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172489|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172490|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172491|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172492|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172493|NCT01282138|E2|Reported Event|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172494|NCT01282138|E1|Reported Event|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
172495|NCT01282086|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172496|NCT01282086|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172497|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172498|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172499|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172500|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172501|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172502|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172503|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172504|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172505|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery.
172506|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172507|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172508|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172509|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172510|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172511|NCT01282086|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
172512|NCT01281865|B3|Baseline|Total|Total of all reporting groups
172513|NCT01281865|B2|Baseline|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172514|NCT01281865|B1|Baseline|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172515|NCT01281865|P2|Participant Flow|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172516|NCT01281865|P1|Participant Flow|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172517|NCT01281865|O2|Outcome|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172518|NCT01281865|O1|Outcome|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172519|NCT01281865|E2|Reported Event|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172520|NCT01281865|E1|Reported Event|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
172521|NCT01281839|B3|Baseline|Total|Total of all reporting groups
172522|NCT01281839|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172523|NCT01281839|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172524|NCT01281839|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172525|NCT01281839|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
188767|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
172526|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172527|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172528|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172529|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172530|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172531|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172532|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172533|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172534|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172535|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172536|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172537|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172538|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172539|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172540|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172541|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172542|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172543|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172544|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172545|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172546|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172547|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172548|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172549|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172550|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172551|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172552|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172553|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172554|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172555|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172556|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172557|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172558|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172559|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172560|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172561|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172562|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172563|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172564|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172565|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172651|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172566|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172567|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172568|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172569|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172570|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172571|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172572|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172573|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172574|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172575|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172576|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172577|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172578|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172579|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172580|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172581|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172582|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172583|NCT01281839|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
172584|NCT01281839|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
172585|NCT01281644|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
172756|NCT01281202|E1|Reported Event|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
172586|NCT01281644|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
172587|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
172588|NCT01281644|O1|Outcome|No Laser Treatment|
172589|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
172590|NCT01281644|O1|Outcome|No Laser Treatment|
172591|NCT01281644|E2|Reported Event|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
172592|NCT01281644|E1|Reported Event|No Laser Treatment|
172593|NCT01281501|B3|Baseline|Total|Total of all reporting groups
172594|NCT01281501|B2|Baseline|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172595|NCT01281501|B1|Baseline|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172596|NCT01281501|P2|Participant Flow|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172597|NCT01281501|P1|Participant Flow|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172598|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172599|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172600|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172601|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172602|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172603|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172604|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172605|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172606|NCT01281501|E2|Reported Event|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
172607|NCT01281501|E1|Reported Event|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
172608|NCT01281475|B3|Baseline|Total|Total of all reporting groups
172609|NCT01281475|B2|Baseline|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~It is also taken 3 times a day, just like Levodopa."
172610|NCT01281475|B1|Baseline|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
172611|NCT01281475|P2|Participant Flow|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
172612|NCT01281475|P1|Participant Flow|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
172613|NCT01281475|O2|Outcome|Placebo|"The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.~Placebo Oral Capsule: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa."
172614|NCT01281475|O1|Outcome|Levodopa|"Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses.~Levodopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
172615|NCT01281475|O2|Outcome|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~The placebo capsules are taken 3 times a day, just like the levodopa / carbidopa capsules"
172616|NCT01281475|O1|Outcome|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
172617|NCT01281475|E2|Reported Event|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
172652|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172653|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172618|NCT01281475|E1|Reported Event|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
172619|NCT01281306|B8|Baseline|Total|Total of all reporting groups
172620|NCT01281306|B7|Baseline|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172621|NCT01281306|B6|Baseline|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172622|NCT01281306|B5|Baseline|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172623|NCT01281306|B4|Baseline|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172624|NCT01281306|B3|Baseline|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172625|NCT01281306|B2|Baseline|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172626|NCT01281306|B1|Baseline|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172627|NCT01281306|P7|Participant Flow|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172628|NCT01281306|P6|Participant Flow|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172629|NCT01281306|P5|Participant Flow|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172630|NCT01281306|P4|Participant Flow|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172631|NCT01281306|P3|Participant Flow|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172632|NCT01281306|P2|Participant Flow|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172633|NCT01281306|P1|Participant Flow|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172634|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172635|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172636|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172637|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172638|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172639|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172640|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172641|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172642|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172643|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172644|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172645|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172646|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172647|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172648|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172649|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172650|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172825|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172654|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172655|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172656|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172657|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172658|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172659|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172660|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172661|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172662|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172663|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172664|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172665|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172666|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172667|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172668|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172669|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172670|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172671|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172672|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172673|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172674|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172675|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172676|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172677|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172678|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172679|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172680|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172681|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172682|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172683|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172684|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172685|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172686|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172687|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172688|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172689|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172690|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172691|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172692|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172693|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172694|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172695|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172696|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172697|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172698|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172699|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172700|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172701|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172702|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172703|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172704|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172705|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172706|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172707|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172708|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172709|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172710|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172711|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172712|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172713|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172714|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172715|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172716|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172717|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172718|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172719|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172720|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172721|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172722|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172723|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172724|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172725|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172726|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172727|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172728|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172729|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172730|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172731|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172732|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172733|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172734|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172735|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172736|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172737|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172738|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172739|NCT01281306|E7|Reported Event|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
172740|NCT01281306|E6|Reported Event|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
172741|NCT01281306|E5|Reported Event|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
172742|NCT01281306|E4|Reported Event|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
172743|NCT01281306|E3|Reported Event|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
172744|NCT01281306|E2|Reported Event|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
172745|NCT01281306|E1|Reported Event|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
172746|NCT01281202|B3|Baseline|Total|Total of all reporting groups
172747|NCT01281202|B2|Baseline|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
172748|NCT01281202|B1|Baseline|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
172749|NCT01281202|P2|Participant Flow|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
172750|NCT01281202|P1|Participant Flow|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
172751|NCT01281202|O2|Outcome|Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks~Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
172752|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
172753|NCT01281202|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
172754|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
172755|NCT01281202|E2|Reported Event|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
172757|NCT01281124|B1|Baseline|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
172758|NCT01281124|P1|Participant Flow|Treatment (5-Azacytidine)|Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
172759|NCT01281124|O1|Outcome|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
172760|NCT01281124|O1|Outcome|Treatment (5-Azacytidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
172761|NCT01281124|O1|Outcome|Treatment (5-Azacyitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
172762|NCT01281124|E1|Reported Event|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
172763|NCT01281007|B3|Baseline|Total|Total of all reporting groups
172764|NCT01281007|B2|Baseline|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
172765|NCT01281007|B1|Baseline|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
172766|NCT01281007|P2|Participant Flow|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
172767|NCT01281007|P1|Participant Flow|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
172768|NCT01281007|O2|Outcome|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
172769|NCT01281007|O1|Outcome|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
172770|NCT01281007|E2|Reported Event|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
172771|NCT01281007|E1|Reported Event|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
172772|NCT01280981|B1|Baseline|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172773|NCT01280981|P1|Participant Flow|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172774|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172775|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172776|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172777|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172778|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172779|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172780|NCT01280981|E1|Reported Event|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
172781|NCT01280968|B3|Baseline|Total|Total of all reporting groups
172782|NCT01280968|B2|Baseline|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172783|NCT01280968|B1|Baseline|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172784|NCT01280968|P2|Participant Flow|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172785|NCT01280968|P1|Participant Flow|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172786|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172787|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
172788|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172789|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172790|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
172791|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172826|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172792|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172793|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
172794|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172795|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172796|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
172797|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172798|NCT01280968|E2|Reported Event|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
172799|NCT01280968|E1|Reported Event|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
172800|NCT01280955|B1|Baseline|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172801|NCT01280955|P1|Participant Flow|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172802|NCT01280955|O1|Outcome|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172803|NCT01280955|O1|Outcome|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172804|NCT01280955|O1|Outcome|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172805|NCT01280955|O1|Outcome|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172806|NCT01280955|E1|Reported Event|Matched Sibling or Dual Cord Donor|"This arm will be stratified into transplant recipients from 30 matched sibling donors and 20 dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
172807|NCT01280695|B6|Baseline|Total|Total of all reporting groups
172808|NCT01280695|B5|Baseline|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172809|NCT01280695|B4|Baseline|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172810|NCT01280695|B3|Baseline|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172811|NCT01280695|B2|Baseline|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172812|NCT01280695|B1|Baseline|Placebo|Placebo capsule once daily
172813|NCT01280695|P5|Participant Flow|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172814|NCT01280695|P4|Participant Flow|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172815|NCT01280695|P3|Participant Flow|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172816|NCT01280695|P2|Participant Flow|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172817|NCT01280695|P1|Participant Flow|Placebo|Placebo capsule once daily
172818|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172819|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172820|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172821|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172822|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
172823|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172824|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172831|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172832|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
172833|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172834|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172835|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172836|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172837|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
172838|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172839|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172840|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172841|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172842|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
172843|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172844|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172845|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172846|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172847|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
172848|NCT01280695|E5|Reported Event|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
172849|NCT01280695|E4|Reported Event|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
172850|NCT01280695|E3|Reported Event|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
172851|NCT01280695|E2|Reported Event|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
172852|NCT01280695|E1|Reported Event|Placebo|Placebo capsule once daily
172853|NCT01280656|B4|Baseline|Total|Total of all reporting groups
172854|NCT01280656|B3|Baseline|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172855|NCT01280656|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172856|NCT01280656|B1|Baseline|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172857|NCT01280656|P3|Participant Flow|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172858|NCT01280656|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172859|NCT01280656|P1|Participant Flow|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172860|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172861|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172862|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172863|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172864|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172865|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172866|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172867|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172868|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172869|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172870|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172871|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172872|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172873|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172874|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172875|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172876|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172877|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172878|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172879|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172880|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172881|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172882|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172883|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172884|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172885|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172886|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172887|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172888|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172889|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172890|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172891|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172892|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
188768|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
172893|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172894|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172895|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172896|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172897|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172898|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
172899|NCT01280656|E3|Reported Event|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
172900|NCT01280656|E2|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
172901|NCT01280656|E1|Reported Event|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
172902|NCT01280604|B3|Baseline|Total|Total of all reporting groups
172903|NCT01280604|B2|Baseline|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172904|NCT01280604|B1|Baseline|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172905|NCT01280604|P2|Participant Flow|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172906|NCT01280604|P1|Participant Flow|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172907|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172908|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172909|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172910|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172911|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172912|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172913|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172914|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172915|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172916|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172917|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172918|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172919|NCT01280604|E2|Reported Event|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
172920|NCT01280604|E1|Reported Event|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
172921|NCT01280591|B5|Baseline|Total|Total of all reporting groups
172922|NCT01280591|B4|Baseline|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172923|NCT01280591|B3|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172924|NCT01280591|B2|Baseline|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173006|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172925|NCT01280591|B1|Baseline|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172926|NCT01280591|P4|Participant Flow|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172927|NCT01280591|P3|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172928|NCT01280591|P2|Participant Flow|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172929|NCT01280591|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172930|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172931|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172932|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172933|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172934|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172935|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172936|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172937|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172938|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172939|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172940|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172941|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172942|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172943|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172944|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172945|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172946|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172947|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172948|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172949|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172950|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172951|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172952|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172953|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172954|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172955|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172956|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172957|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172958|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172959|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172960|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172961|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172962|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172963|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172964|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173007|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172965|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172966|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172967|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172968|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172969|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172970|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172971|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172972|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172973|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172974|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172975|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172976|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172977|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172978|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172979|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172980|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172981|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172982|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172983|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172984|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172985|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172986|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172987|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172988|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172989|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172990|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172991|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172992|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172993|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172994|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172995|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
172996|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
172997|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
172998|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
172999|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
173000|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173001|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
173002|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
173003|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
173004|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173005|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
173008|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173009|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
173010|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
173011|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
173012|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173013|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
173014|NCT01280591|E4|Reported Event|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
173015|NCT01280591|E3|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
173016|NCT01280591|E2|Reported Event|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
173017|NCT01280591|E1|Reported Event|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
173018|NCT01280552|B3|Baseline|Total|Total of all reporting groups
173019|NCT01280552|B2|Baseline|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173020|NCT01280552|B1|Baseline|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173021|NCT01280552|P2|Participant Flow|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173022|NCT01280552|P1|Participant Flow|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173023|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173024|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173025|NCT01280552|O2|Outcome|Control|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173026|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173027|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173028|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173029|NCT01280552|O2|Outcome|Control Dendritic Cells|Treatment with autologous dendritic cells not pulsed with immunogenic peptides
173030|NCT01280552|O1|Outcome|ICT-107|Treatment with autologous dendritic cells pulsed with immunogenic peptides
173031|NCT01280552|E2|Reported Event|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
173032|NCT01280552|E1|Reported Event|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
173033|NCT01280357|B1|Baseline|Monitor With the Philips 50XM, Remove Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
173034|NCT01280357|P1|Participant Flow|All Participants|during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM
173035|NCT01280357|O1|Outcome|All Participants|all participants that had maternal heart rate measured with the Monica AN24 & the Philips 50XM
173036|NCT01280357|O1|Outcome|All Participants|all participants that had fetal heart rate measured with the Monica AN24 & the Philips 50XM
173037|NCT01280357|O1|Outcome|All Participants|Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
173038|NCT01280357|E2|Reported Event|Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
173039|NCT01280357|E1|Reported Event|Philips 50XM,|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
173040|NCT01280266|B3|Baseline|Total|Total of all reporting groups
173041|NCT01280266|B2|Baseline|Udenafil-Amlodipine (UA) Arm|Udenafil first, then Amlodipine
173042|NCT01280266|B1|Baseline|Amlodipine-Udenafil (AU) Arm|Amlodipine first, then Udenafil
173043|NCT01280266|P2|Participant Flow|Udenafil-Amlodipine (UA) Arm|Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
173044|NCT01280266|P1|Participant Flow|Amlodipine-Udenafil (AU) Arm|Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
173045|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173046|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173047|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173048|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173049|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173050|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173051|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173052|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173054|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173055|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173056|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173057|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
173058|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
173059|NCT01280266|O2|Outcome|Udenafil|Changes in RPS during udenafil 10 mg orally per day
173060|NCT01280266|O1|Outcome|Amlodipine|Changes in RPS during amlodipine 100 mg orally per day
173061|NCT01280266|O2|Outcome|Udenafil|Changes in RP attacks per day during udenafil 100mg orally per day
173062|NCT01280266|O1|Outcome|Amlodipine|Changes in RP attacks per day during amlodipine 10 mg orally per day
173063|NCT01280266|E2|Reported Event|Udenafil|Adverse effects observed while taking udenafil in both study arms
173064|NCT01280266|E1|Reported Event|Amlodipine|Adverse effects observed while taking amlodipine in both study arms
173065|NCT01280123|B4|Baseline|Total|Total of all reporting groups
173066|NCT01280123|B3|Baseline|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173067|NCT01280123|B2|Baseline|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173068|NCT01280123|B1|Baseline|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173069|NCT01280123|P3|Participant Flow|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173070|NCT01280123|P2|Participant Flow|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173071|NCT01280123|P1|Participant Flow|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173072|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173073|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173074|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173075|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173076|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173077|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173078|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173223|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173079|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173080|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173081|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173082|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173083|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173084|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173085|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173086|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173087|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173088|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173089|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173090|NCT01280123|E3|Reported Event|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
173091|NCT01280123|E2|Reported Event|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173092|NCT01280123|E1|Reported Event|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
173093|NCT01280110|B3|Baseline|Total|Total of all reporting groups
173094|NCT01280110|B2|Baseline|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
173095|NCT01280110|B1|Baseline|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
173096|NCT01280110|P2|Participant Flow|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
173097|NCT01280110|P1|Participant Flow|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
188769|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
173098|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
173099|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
173100|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
173101|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
173102|NCT01280110|E2|Reported Event|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
173103|NCT01280110|E1|Reported Event|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
173104|NCT01279564|B3|Baseline|Total|Total of all reporting groups
173105|NCT01279564|B2|Baseline|Control|"Intubation~Endotracheal tube: Intubation"
173106|NCT01279564|B1|Baseline|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
173107|NCT01279564|P2|Participant Flow|Control|"Intubation~Endotracheal tube- standard"
173108|NCT01279564|P1|Participant Flow|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
173109|NCT01279564|O2|Outcome|Control|"Intubation~Duration of intubation"
173110|NCT01279564|O1|Outcome|ETview|"Endotracheal intubation with ETview TVT~Duration of intubation"
173111|NCT01279564|E2|Reported Event|Control|"Intubation~Endotracheal tube: Intubation~No adverse events"
173112|NCT01279564|E1|Reported Event|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation~No adverse events"
173113|NCT01279447|B3|Baseline|Total|Total of all reporting groups
173114|NCT01279447|B2|Baseline|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
173115|NCT01279447|B1|Baseline|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
173116|NCT01279447|P2|Participant Flow|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
173117|NCT01279447|P1|Participant Flow|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
173118|NCT01279447|O2|Outcome|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
173119|NCT01279447|O1|Outcome|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
173120|NCT01279447|E2|Reported Event|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
173121|NCT01279447|E1|Reported Event|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
173122|NCT01279317|B1|Baseline|Vinegar Co-ingestion|All participants performed both intervention periods.
173123|NCT01279317|P2|Participant Flow|Placebo Co-ingestion First, Then Vinegar Co-ingestion|First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day).
173124|NCT01279317|P1|Participant Flow|Vinegar Co-ingestion First, Then Placebo Co-intestion|First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day).
173125|NCT01279317|O2|Outcome|Placebo Co-ingestion|
173126|NCT01279317|O1|Outcome|Vinegar Co-ingestion|
173127|NCT01279317|E1|Reported Event|Vinegar Co-ingestion|All participants performed both intervention periods.
173128|NCT01279265|B3|Baseline|Total|Total of all reporting groups
173129|NCT01279265|B2|Baseline|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173130|NCT01279265|B1|Baseline|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
173131|NCT01279265|P2|Participant Flow|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173132|NCT01279265|P1|Participant Flow|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
173133|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173134|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|"Formula with probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG"
173135|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173136|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
173137|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173138|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
173139|NCT01279265|E2|Reported Event|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
173140|NCT01279265|E1|Reported Event|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
173141|NCT01279200|B3|Baseline|Total|Total of all reporting groups
173142|NCT01279200|B2|Baseline|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
173143|NCT01279200|B1|Baseline|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
173144|NCT01279200|P2|Participant Flow|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
173145|NCT01279200|P1|Participant Flow|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
173146|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
173147|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
173148|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
173149|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
173150|NCT01279200|E2|Reported Event|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
173151|NCT01279200|E1|Reported Event|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
173152|NCT01279070|B3|Baseline|Total|Total of all reporting groups
173153|NCT01279070|B2|Baseline|Repyflec Training|Cognitive remediation treatment
173154|NCT01279070|B1|Baseline|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
173155|NCT01279070|P2|Participant Flow|Leisure Group (Control Group)|"Leisure group~Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, etc.) over 4 months twice a week and lasting 1 h."
173156|NCT01279070|P1|Participant Flow|Experimental Group (Repyflec Cognitive Remediation)|"Cognitive remediation (CR) group training (Repyflec)~REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF)."
173157|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
173158|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
173159|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
173160|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
173161|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
173162|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
173163|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
173164|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
173165|NCT01279070|O2|Outcome|Leisure & Socialization Group|"Parallel to the experimental group, a leisure group was established (control group) which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, geography review, etc)."
173189|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173190|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173221|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173785|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173166|NCT01279070|O1|Outcome|REPYFLEC Cognitive Group Trainining|"REPYFLEC is a strategy-based training, explicitly described from session to session, which is carried out using pencil and paper with a blackboard as visual support. This format allows results to be replicated with rigour. The working content is divided into two principal areas: Problem solving (PS) and Cognitive Flexibility (CF). In the PS block, training in executive function, the thinking process and self-monitoring was emphasized. In the CF block, the tasks require the use of cognitive flexibility for successful completion. Some activities seek to promote training of other functions such as memory, working memory, sustained attention and language. Development of training was performed taking into account the contextual bases of learning, mainly using techniques as modelling to foster coping abilities, molding, self-monitoring, errorless learning and Socratic questioning. REPYFLEC is carried out in a group format (4-6), consisting of 32 sessions lasting 1 hour."
173167|NCT01279070|O2|Outcome|Leisure & Socialization Group|"The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, coffee & talk, geography review, etc.)without specific goals."
173168|NCT01279070|O1|Outcome|REPYFLEC Cognitive Remediation Group Training|REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
173169|NCT01279070|E2|Reported Event|Repyflec Training|Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility
173170|NCT01279070|E1|Reported Event|Leisure Group|Stimulating activities without specific goals and focused on leisure
173171|NCT01279044|B4|Baseline|Total|Total of all reporting groups
173172|NCT01279044|B3|Baseline|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173173|NCT01279044|B2|Baseline|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173174|NCT01279044|B1|Baseline|Phase 1 - Formative Research|Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
173175|NCT01279044|P3|Participant Flow|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173176|NCT01279044|P2|Participant Flow|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173177|NCT01279044|P1|Participant Flow|Formative Phase 1|Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
173178|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173179|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173180|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173181|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173182|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173183|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173184|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173185|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173186|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173187|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173188|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173222|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173191|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173192|NCT01279044|E2|Reported Event|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
173193|NCT01279044|E1|Reported Event|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
173194|NCT01278953|B3|Baseline|Total|Total of all reporting groups
173195|NCT01278953|B2|Baseline|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173196|NCT01278953|B1|Baseline|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173197|NCT01278953|P2|Participant Flow|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173198|NCT01278953|P1|Participant Flow|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173199|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173200|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173201|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173202|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173203|NCT01278953|E2|Reported Event|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173204|NCT01278953|E1|Reported Event|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
173205|NCT01278927|B5|Baseline|Total|Total of all reporting groups
173206|NCT01278927|B4|Baseline|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173207|NCT01278927|B3|Baseline|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173208|NCT01278927|B2|Baseline|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173209|NCT01278927|B1|Baseline|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173210|NCT01278927|P4|Participant Flow|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173211|NCT01278927|P3|Participant Flow|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173212|NCT01278927|P2|Participant Flow|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173213|NCT01278927|P1|Participant Flow|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173214|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173215|NCT01278927|O3|Outcome|Exercise and Stress Management|Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173216|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173217|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173218|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173219|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173220|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173916|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173224|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173225|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173226|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173227|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173228|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173229|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173230|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173231|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173232|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173233|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173234|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173235|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173236|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173237|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173238|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173239|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173240|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173241|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173242|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
173243|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
173244|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
173245|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
173246|NCT01278927|E4|Reported Event|Standard Care|"Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).~Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD."
173247|NCT01278927|E3|Reported Event|Exercise and Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions."
173248|NCT01278927|E2|Reported Event|Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention."
174648|NCT01272934|P2|Participant Flow|Placebo|Placebo : Topical gel-4 times daily
173249|NCT01278927|E1|Reported Event|Exercise|"Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.~Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention."
173250|NCT01278797|B1|Baseline|Entire Study Population|Includes all subjects randomized to either treatment sequence
173251|NCT01278797|P2|Participant Flow|Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg|Individual components followed by Combination tablet
173252|NCT01278797|P1|Participant Flow|Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg|Combination tablet followed by individual components
173253|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
173254|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
173255|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
173256|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
173257|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
173258|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
173259|NCT01278797|E2|Reported Event|Telm 80 mg + Amlo 10 mg|Individual tablets
173260|NCT01278797|E1|Reported Event|Telm/Amlo 80 mg/10 mg|Combination tablet
173261|NCT01278615|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173262|NCT01278615|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173263|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173264|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173265|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173266|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173267|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173268|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173269|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173270|NCT01278615|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
173271|NCT01278485|B1|Baseline|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173272|NCT01278485|P1|Participant Flow|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173273|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173274|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173275|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173276|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173277|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
174002|NCT01276353|E4|Reported Event|E2020 10 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173278|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173279|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173280|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173281|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173282|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173283|NCT01278485|E1|Reported Event|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
173284|NCT01278407|B4|Baseline|Total|Total of all reporting groups
173285|NCT01278407|B3|Baseline|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
173286|NCT01278407|B2|Baseline|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
173287|NCT01278407|B1|Baseline|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
173288|NCT01278407|P5|Participant Flow|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
173289|NCT01278407|P4|Participant Flow|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
173290|NCT01278407|P3|Participant Flow|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
173291|NCT01278407|P2|Participant Flow|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
173292|NCT01278407|P1|Participant Flow|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
173293|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
173294|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
173295|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
173296|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
173297|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
173298|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
173299|NCT01278407|E5|Reported Event|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
173300|NCT01278407|E4|Reported Event|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
173301|NCT01278407|E3|Reported Event|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
173461|NCT01277601|B1|Baseline|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173302|NCT01278407|E2|Reported Event|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
173303|NCT01278407|E1|Reported Event|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
173304|NCT01278394|B1|Baseline|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173305|NCT01278394|P1|Participant Flow|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173306|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173307|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173308|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173309|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173310|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173311|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173312|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173313|NCT01278394|E1|Reported Event|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
173314|NCT01278342|B4|Baseline|Total|Total of all reporting groups
173315|NCT01278342|B3|Baseline|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173316|NCT01278342|B2|Baseline|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173317|NCT01278342|B1|Baseline|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
173318|NCT01278342|P3|Participant Flow|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173319|NCT01278342|P2|Participant Flow|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173320|NCT01278342|P1|Participant Flow|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
173321|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173322|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173323|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
173324|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173325|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173326|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
173462|NCT01277601|P4|Participant Flow|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173327|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173328|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173329|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
173330|NCT01278342|E3|Reported Event|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
173331|NCT01278342|E2|Reported Event|Sandostatin LAR High Dose + Pegvisomant|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
173332|NCT01278342|E1|Reported Event|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
173333|NCT01278303|B1|Baseline|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173334|NCT01278303|P1|Participant Flow|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173335|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173336|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173337|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173338|NCT01278303|E1|Reported Event|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
173339|NCT01277211|B3|Baseline|Total|Total of all reporting groups
173340|NCT01277211|B2|Baseline|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173341|NCT01277211|B1|Baseline|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173342|NCT01277211|P2|Participant Flow|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173343|NCT01277211|P1|Participant Flow|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173344|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173345|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173346|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173399|NCT01278030|O1|Outcome|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
173347|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173348|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173349|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173350|NCT01277211|E2|Reported Event|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
173351|NCT01277211|E1|Reported Event|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
173352|NCT01277081|B3|Baseline|Total|Total of all reporting groups
173353|NCT01277081|B2|Baseline|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173354|NCT01277081|B1|Baseline|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173355|NCT01277081|P2|Participant Flow|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173356|NCT01277081|P1|Participant Flow|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173357|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173358|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173359|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173360|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173361|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173362|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173363|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173364|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173365|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173366|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173367|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173368|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173369|NCT01277081|E2|Reported Event|Paracetamol Tablets|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
173370|NCT01277081|E1|Reported Event|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
173371|NCT01278173|B1|Baseline|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
173372|NCT01278173|P1|Participant Flow|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
173373|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
173374|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
173375|NCT01278173|E1|Reported Event|Vigabatrin|
173376|NCT01278160|B3|Baseline|Total|Total of all reporting groups
173377|NCT01278160|B2|Baseline|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173378|NCT01278160|B1|Baseline|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173379|NCT01278160|P2|Participant Flow|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173380|NCT01278160|P1|Participant Flow|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173381|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173382|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173383|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173384|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173385|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173386|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173387|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173388|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173389|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173390|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173391|NCT01278160|E2|Reported Event|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173392|NCT01278160|E1|Reported Event|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
173393|NCT01278030|B3|Baseline|Total|Total of all reporting groups
173394|NCT01278030|B2|Baseline|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
173395|NCT01278030|B1|Baseline|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
173396|NCT01278030|P2|Participant Flow|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
173397|NCT01278030|P1|Participant Flow|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
173398|NCT01278030|O2|Outcome|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
173400|NCT01278030|E2|Reported Event|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
173401|NCT01278030|E1|Reported Event|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
173402|NCT01277861|B3|Baseline|Total|Total of all reporting groups
173403|NCT01277861|B2|Baseline|SALINE|SALINE
173404|NCT01277861|B1|Baseline|FENTANYL|FENTANYL
173405|NCT01277861|P2|Participant Flow|SALINE|SALINE
173406|NCT01277861|P1|Participant Flow|FENTANYL|FENTANYL
173407|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
173408|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
173409|NCT01277861|O2|Outcome|Saline Pretreatment Group|
173410|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|
173411|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
173412|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
173413|NCT01277861|E2|Reported Event|SALINE|SALINE
173414|NCT01277861|E1|Reported Event|FENTANYL|FENTANYL
173415|NCT01277822|B3|Baseline|Total|Total of all reporting groups
173416|NCT01277822|B2|Baseline|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173417|NCT01277822|B1|Baseline|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173418|NCT01277822|P2|Participant Flow|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173419|NCT01277822|P1|Participant Flow|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173420|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173421|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173422|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173423|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173424|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173425|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173426|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173427|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173428|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173429|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173430|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173431|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173432|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173433|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173434|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
173435|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
173436|NCT01277822|E2|Reported Event|Amlodipine 10mg|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
188770|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
173437|NCT01277822|E1|Reported Event|Losartan 100mg/Amlodipine 5mg|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks
173438|NCT01277757|B1|Baseline|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173439|NCT01277757|P1|Participant Flow|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173440|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173441|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173442|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173443|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173444|NCT01277757|E1|Reported Event|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
173445|NCT01277718|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
173446|NCT01277718|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. There was minimum of a 13-day washout between cobimetinib doses of each period.
173447|NCT01277718|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. There was minimum of a 13-day washout between cobimetinib doses of each period.
173448|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
173449|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173450|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173451|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
173452|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173453|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173454|NCT01277718|E3|Reported Event|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
173455|NCT01277718|E2|Reported Event|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173456|NCT01277718|E1|Reported Event|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
173457|NCT01277601|B5|Baseline|Total|Total of all reporting groups
173458|NCT01277601|B4|Baseline|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173459|NCT01277601|B3|Baseline|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
173460|NCT01277601|B2|Baseline|TDF 48 Weeks + Peg-IFN 16 Week|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173463|NCT01277601|P3|Participant Flow|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
173464|NCT01277601|P2|Participant Flow|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173465|NCT01277601|P1|Participant Flow|TDF+Peg-IFN 48 Weeks|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
173466|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173467|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173468|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173469|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173470|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173471|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173472|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173473|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173474|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173475|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173476|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173477|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173478|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173479|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173480|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173481|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173482|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173483|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173484|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173485|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173486|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173487|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173488|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173489|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173490|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173491|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173492|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173493|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173494|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173495|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173496|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173571|NCT01277523|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173497|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173498|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173499|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173500|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173501|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173502|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173503|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173504|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173505|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173506|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173507|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173508|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173509|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173510|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173511|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173512|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173513|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173514|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173515|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173516|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173517|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173518|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173519|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173520|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173521|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173522|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173523|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173524|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173525|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173526|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173527|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
173528|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173529|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
173530|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
173531|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
173532|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173533|NCT01277601|O3|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
173534|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173535|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173536|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173537|NCT01277601|O3|Outcome|TDF 120 Week|TDF 300 mg tablet once daily for 120 weeks
173538|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173539|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173540|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173541|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
173542|NCT01277601|O1|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
173543|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173544|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
173545|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
173546|NCT01277601|E7|Reported Event|Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).~TDF 300 mg tablet once daily up to Week 120"
173547|NCT01277601|E6|Reported Event|Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
173548|NCT01277601|E5|Reported Event|TDF 120 Weeks|"Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).~TDF 300 mg tablet once daily for up to 120 weeks"
173549|NCT01277601|E4|Reported Event|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
173550|NCT01277601|E3|Reported Event|TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks"
173551|NCT01277601|E2|Reported Event|TDF+Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
173552|NCT01277601|E1|Reported Event|TDF+Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
173553|NCT01277549|B3|Baseline|Total|Total of all reporting groups
173554|NCT01277549|B2|Baseline|Nonmobilized Donors|Donors not mobilized prior to MNC collection
173555|NCT01277549|B1|Baseline|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
173556|NCT01277549|P2|Participant Flow|Non-mobilized Donors|In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
173557|NCT01277549|P1|Participant Flow|G-CSF Mobilized Donors|In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
173558|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
173559|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
173560|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
173561|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
173562|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
173563|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
173564|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
173565|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
173566|NCT01277549|O2|Outcome|Nonmobilized Donors|Donors were not mobilized prior to MNC collection.
173567|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
173568|NCT01277549|E2|Reported Event|Nonmobilized Donors|"Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not at risk."
173569|NCT01277549|E1|Reported Event|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
173570|NCT01277523|B4|Baseline|Total|Total of all reporting groups
174961|NCT01272284|B1|Baseline|Altis® SIS|Participants implanted with Altis® Single Incision Sling
173572|NCT01277523|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173573|NCT01277523|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173574|NCT01277523|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173575|NCT01277523|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173576|NCT01277523|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173577|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173578|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173579|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173580|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173581|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173582|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173583|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173584|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173585|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173586|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173587|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173588|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173589|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173590|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173591|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173592|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173593|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173594|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173595|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173596|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173597|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173598|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173599|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173600|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173601|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173602|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173603|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173604|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173605|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173606|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173607|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173608|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
188771|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
173609|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173610|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173611|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173612|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173613|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173614|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173615|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173616|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173617|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173618|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173619|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173620|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173621|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173622|NCT01277523|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173623|NCT01277523|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173624|NCT01277523|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
173625|NCT01277510|B3|Baseline|Total|Total of all reporting groups
173626|NCT01277510|B2|Baseline|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173627|NCT01277510|B1|Baseline|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173628|NCT01277510|P2|Participant Flow|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173629|NCT01277510|P1|Participant Flow|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173630|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173631|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173632|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173652|NCT01277354|B1|Baseline|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
173653|NCT01277354|P2|Participant Flow|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
173633|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173634|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173635|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173636|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173637|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173638|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173639|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173640|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173641|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173642|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173643|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173644|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
173645|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
173646|NCT01277510|E4|Reported Event|Open-label Phase: Previous Cinacalcet|
173647|NCT01277510|E3|Reported Event|Open-label Phase: Previous Placebo|
173648|NCT01277510|E2|Reported Event|Double-blind Phase: Cinacalcet|
173649|NCT01277510|E1|Reported Event|Double-blind Phase: Placebo|
173650|NCT01277354|B3|Baseline|Total|Total of all reporting groups
173651|NCT01277354|B2|Baseline|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
173654|NCT01277354|P1|Participant Flow|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
173655|NCT01277354|O2|Outcome|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
173656|NCT01277354|O1|Outcome|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
173657|NCT01277354|E2|Reported Event|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
173658|NCT01277354|E1|Reported Event|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
173659|NCT01277302|B4|Baseline|Total|Total of all reporting groups
173660|NCT01277302|B3|Baseline|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173661|NCT01277302|B2|Baseline|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173662|NCT01277302|B1|Baseline|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173663|NCT01277302|P3|Participant Flow|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173664|NCT01277302|P2|Participant Flow|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173665|NCT01277302|P1|Participant Flow|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173666|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173667|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173668|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173669|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173670|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173671|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173672|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173673|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173674|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173675|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173676|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173677|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173678|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173679|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173680|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173681|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173682|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173683|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173684|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173685|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173686|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173687|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173688|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173714|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173689|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173690|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173691|NCT01277302|E3|Reported Event|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173692|NCT01277302|E2|Reported Event|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
173693|NCT01277302|E1|Reported Event|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
173694|NCT01277042|B3|Baseline|Total|Total of all reporting groups
173695|NCT01277042|B2|Baseline|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173696|NCT01277042|B1|Baseline|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173697|NCT01277042|P2|Participant Flow|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173698|NCT01277042|P1|Participant Flow|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173699|NCT01277042|O2|Outcome|Engerix-B Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173700|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173701|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173702|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173703|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173704|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173705|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173706|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173707|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173708|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173709|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173710|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173711|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173712|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173713|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173782|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
188772|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
173715|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173716|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173717|NCT01277042|E2|Reported Event|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173718|NCT01277042|E1|Reported Event|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
173719|NCT01276847|B4|Baseline|Total|Total of all reporting groups
173720|NCT01276847|B3|Baseline|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
173721|NCT01276847|B2|Baseline|No Treatment|No treatment administered
173722|NCT01276847|B1|Baseline|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
173723|NCT01276847|P3|Participant Flow|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
173724|NCT01276847|P2|Participant Flow|No Treatment|No treatment administered
173725|NCT01276847|P1|Participant Flow|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
173726|NCT01276847|O1|Outcome|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
173727|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
173728|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
173729|NCT01276847|E3|Reported Event|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
173730|NCT01276847|E2|Reported Event|No Treatment|No treatment administered
173731|NCT01276847|E1|Reported Event|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
173732|NCT01276821|B3|Baseline|Total|Total of all reporting groups
173733|NCT01276821|B2|Baseline|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173734|NCT01276821|B1|Baseline|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173735|NCT01276821|P2|Participant Flow|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173736|NCT01276821|P1|Participant Flow|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173737|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173738|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173739|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173740|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173741|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173742|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173743|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173744|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173745|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173746|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173747|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173748|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173749|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173750|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173751|NCT01276821|E2|Reported Event|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
173752|NCT01276821|E1|Reported Event|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
173753|NCT01276756|B3|Baseline|Total|Total of all reporting groups
173754|NCT01276756|B2|Baseline|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173755|NCT01276756|B1|Baseline|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173783|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173784|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173756|NCT01276756|P2|Participant Flow|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173757|NCT01276756|P1|Participant Flow|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173758|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173759|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173760|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173761|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173762|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173763|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173764|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173765|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173766|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173767|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173768|NCT01276756|E2|Reported Event|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173769|NCT01276756|E1|Reported Event|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
173770|NCT01276639|B4|Baseline|Total|Total of all reporting groups
173771|NCT01276639|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173772|NCT01276639|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173773|NCT01276639|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173774|NCT01276639|P5|Participant Flow|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173775|NCT01276639|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173776|NCT01276639|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173777|NCT01276639|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173778|NCT01276639|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
173779|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173780|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173781|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173786|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173787|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173788|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173789|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173790|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173791|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173792|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173793|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173794|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173795|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173796|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173797|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173798|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173799|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173800|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173801|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173802|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173803|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173804|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173805|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173806|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173807|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173808|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173809|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173810|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173811|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173812|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173813|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173814|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173815|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173816|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173817|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173818|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173819|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173820|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173821|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173822|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173823|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173824|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173825|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173826|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173827|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173828|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173829|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
175768|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
173830|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173831|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173832|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173833|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173834|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173835|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173836|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173837|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173838|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173839|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173840|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173841|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173842|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173843|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173844|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173845|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173846|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173847|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173848|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173849|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173850|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173851|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173852|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173853|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173854|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173855|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173856|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173857|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173858|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173859|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173860|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173861|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173862|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173863|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173864|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173865|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173866|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173867|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173868|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173869|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173870|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173871|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173872|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
174003|NCT01276353|E3|Reported Event|E2020 SR 23 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173873|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173874|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173875|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173876|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173877|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173878|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173879|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173880|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173881|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173882|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173883|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173884|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173885|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173886|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173887|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173888|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173889|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173890|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173891|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173892|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173893|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173894|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173895|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173896|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173897|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173898|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173899|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173900|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173901|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173902|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173903|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173904|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173905|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173906|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173907|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173908|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173909|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173910|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173911|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173912|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173913|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173914|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173915|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
188773|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
173917|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173918|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173919|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173920|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173921|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173922|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173923|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173924|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173925|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173926|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173927|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173928|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173929|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173930|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173931|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173932|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173933|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173934|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173935|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173936|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173937|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173938|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
173939|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
173940|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173941|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173942|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173943|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173944|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173945|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173946|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173947|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173948|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173949|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173950|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173951|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173952|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173953|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173954|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173955|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173956|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173957|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173958|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173959|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173960|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173961|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173962|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173963|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173964|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
173965|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173966|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173967|NCT01276639|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
173968|NCT01276639|E4|Reported Event|Placebo, CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
173969|NCT01276639|E3|Reported Event|Placebo, CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
173970|NCT01276639|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
173971|NCT01276639|E1|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
173972|NCT01276535|B1|Baseline|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173973|NCT01276535|P1|Participant Flow|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173974|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173975|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173976|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173977|NCT01276535|E1|Reported Event|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
173978|NCT01276457|B3|Baseline|Total|Total of all reporting groups
173979|NCT01276457|B2|Baseline|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173980|NCT01276457|B1|Baseline|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173981|NCT01276457|P2|Participant Flow|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173982|NCT01276457|P1|Participant Flow|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173983|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173984|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173985|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173986|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173987|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173988|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173989|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173990|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173991|NCT01276457|E2|Reported Event|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173992|NCT01276457|E1|Reported Event|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
173993|NCT01276353|B3|Baseline|Total|Total of all reporting groups
173994|NCT01276353|B2|Baseline|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173995|NCT01276353|B1|Baseline|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173996|NCT01276353|P2|Participant Flow|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173997|NCT01276353|P1|Participant Flow|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173998|NCT01276353|O2|Outcome|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
173999|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
174000|NCT01276353|O2|Outcome|E2020 10 mg (EM)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
174001|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
174004|NCT01276353|E2|Reported Event|E2020 10 mg (Double-blind)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
174005|NCT01276353|E1|Reported Event|E2020 SR 23 mg (Double-blind)|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
174006|NCT01276327|B3|Baseline|Total|Total of all reporting groups
174007|NCT01276327|B2|Baseline|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
174008|NCT01276327|B1|Baseline|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
174009|NCT01276327|P2|Participant Flow|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
174010|NCT01276327|P1|Participant Flow|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
174011|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174012|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174013|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174014|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174015|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174016|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174017|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174018|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174019|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174020|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174021|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174022|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174023|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174024|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174025|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174026|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174027|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174028|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174029|NCT01276327|E2|Reported Event|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
174030|NCT01276327|E1|Reported Event|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
174031|NCT01276301|B1|Baseline|Entire Study Population|"An open label, randomised, two-period crossover trial. The two treatments administered were~A single dose of empagliflozin (empa) 25 mg~A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil~The two treatment periods were separated by a washout period of at least 7 days."
174032|NCT01276301|P2|Participant Flow|Empa Plus Verapamil / Empa|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg.
174033|NCT01276301|P1|Participant Flow|Empa / Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174034|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174035|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174036|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174037|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174038|NCT01276301|O1|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174039|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174040|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174041|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174042|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174043|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174044|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174045|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174046|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174047|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174048|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174049|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174050|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174051|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174052|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174053|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174054|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174055|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174056|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
174057|NCT01276301|E2|Reported Event|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
174058|NCT01276301|E1|Reported Event|Empa|A single dose of empagliflozin (empa) 25 mg.
174059|NCT01276288|B1|Baseline|Overall Patients|A randomised, open-label, multiple-dose, 2- way cross-over study. All patients received 25 mg empagliflozin in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h) (days 1 to 5). Following a wash-out period of seven days, half of the patients received 25 mg hydrochlorothiazide (HCT) either on its own in a form of a film-coated tablet orally once daily (days 1 to 4) or in combination with 25 mg empagliflozin ( days 5 to 9), while the other half of the patients received 5 mg torasemide (TOR) either on its own (days 1 to 4) or in combination with the 25 mg empagliflozin ( days 5 to 9). This sequence was then reversed so that the HCT or TOR and its combination with 25 mg empagliflozin were administered first in a same manner as stated above, followed by 25 mg empagliflozin after seven days wash out period.
174060|NCT01276288|P4|Participant Flow|Empa+TOR/ Empa|Patients received 5mg torasemide (TOR) in combination with 25mg Empa. Following a wash-out period of seven days, 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
174061|NCT01276288|P3|Participant Flow|Empa/ Empa+ TOR|Patients received 25mg Empa in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 5 mg torasemide (TOR) in combination with 25mg Empa was administered.
174062|NCT01276288|P2|Participant Flow|Empa+HCT/ Empa|Patients received 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet orally once daily in combination with 25mg Empa. Following a wash-out period of seven days 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
174063|NCT01276288|P1|Participant Flow|Empa / Empa+HCT|Patients received 25mg empagliflozin (Empa) orally in a form of a film-coated tablet once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet was administered orally once daily in combination with 25mg Empa.
174064|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174065|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174066|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174067|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174068|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174069|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174070|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174071|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174072|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
174073|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
174074|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
174075|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
174076|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
174077|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174078|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
174079|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
174080|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
175769|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
174081|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
174082|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
174083|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174084|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
174085|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174086|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
174087|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174088|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174089|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174090|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174091|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174092|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174093|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174094|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174095|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174096|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174097|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174098|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174099|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174100|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174101|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174102|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174103|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174104|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174105|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174106|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174107|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174108|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174109|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174110|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174111|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174112|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174113|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174114|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174115|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174116|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174117|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174118|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174119|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174120|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174121|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174122|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174123|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174124|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174125|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174126|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174127|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174128|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174129|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174130|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174131|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174132|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174133|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174134|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174135|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174136|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174137|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174138|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174139|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174140|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174141|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174142|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174143|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174144|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174145|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174146|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174147|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174148|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174149|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174150|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174151|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174152|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174153|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174154|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174155|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174156|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174157|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174158|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174159|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174160|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174161|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174162|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174163|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174164|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174165|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174166|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174167|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174168|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174169|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174170|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174171|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174172|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174173|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174174|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174175|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174176|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174177|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174178|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174179|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174180|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174181|NCT01276288|E5|Reported Event|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
174182|NCT01276288|E4|Reported Event|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
174183|NCT01276288|E3|Reported Event|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
174184|NCT01276288|E2|Reported Event|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
174185|NCT01276288|E1|Reported Event|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
174186|NCT01276223|B4|Baseline|Total|Total of all reporting groups
174187|NCT01276223|B3|Baseline|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
174188|NCT01276223|B2|Baseline|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
174189|NCT01276223|B1|Baseline|Run-In Only|Difluprednate vehicle
174190|NCT01276223|P3|Participant Flow|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
174191|NCT01276223|P2|Participant Flow|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
174192|NCT01276223|P1|Participant Flow|Run-In Only|Difluprednate vehicle
174193|NCT01276223|O2|Outcome|Vehicle|Difluprednate vehicle
174194|NCT01276223|O1|Outcome|Durezol|Difluprednate 0.5% ophthalmic emulsion
174195|NCT01276223|E3|Reported Event|Vehicle|Difluprednate vehicle
174196|NCT01276223|E2|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion
174197|NCT01276223|E1|Reported Event|Run-In|Difluprednate vehicle, all patients
174198|NCT01276197|B3|Baseline|Total|Total of all reporting groups
174199|NCT01276197|B2|Baseline|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
174200|NCT01276197|B1|Baseline|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
174201|NCT01276197|P2|Participant Flow|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
174202|NCT01276197|P1|Participant Flow|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
174203|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
174204|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
174205|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
174206|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
174207|NCT01276197|E2|Reported Event|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
174208|NCT01276197|E1|Reported Event|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
174209|NCT01276106|B5|Baseline|Total|Total of all reporting groups
174210|NCT01276106|B4|Baseline|Placebo|Placebo: Capsule, BID
174211|NCT01276106|B3|Baseline|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
174212|NCT01276106|B2|Baseline|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
174213|NCT01276106|B1|Baseline|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
174214|NCT01276106|P4|Participant Flow|Placebo|Placebo: Capsule, BID
174215|NCT01276106|P3|Participant Flow|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
174216|NCT01276106|P2|Participant Flow|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
174217|NCT01276106|P1|Participant Flow|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
174218|NCT01276106|O4|Outcome|Placebo|Placebo: Capsule, BID
174219|NCT01276106|O3|Outcome|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
174220|NCT01276106|O2|Outcome|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
174221|NCT01276106|O1|Outcome|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
174222|NCT01276106|E4|Reported Event|Placebo|Placebo: Capsule, BID
174223|NCT01276106|E3|Reported Event|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
174224|NCT01276106|E2|Reported Event|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
174225|NCT01276106|E1|Reported Event|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
174226|NCT01276054|B3|Baseline|Total|Total of all reporting groups
174227|NCT01276054|B2|Baseline|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
174228|NCT01276054|B1|Baseline|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
174229|NCT01276054|P2|Participant Flow|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
174230|NCT01276054|P1|Participant Flow|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
174231|NCT01276054|O2|Outcome|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
174232|NCT01276054|O1|Outcome|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
174233|NCT01276054|E2|Reported Event|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
174234|NCT01276054|E1|Reported Event|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
174235|NCT01275755|B3|Baseline|Total|Total of all reporting groups
174236|NCT01275755|B2|Baseline|ADL5945 0.25mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
174237|NCT01275755|B1|Baseline|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
174238|NCT01275755|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
174239|NCT01275755|P1|Participant Flow|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
174240|NCT01275755|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
174241|NCT01275755|O1|Outcome|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
174242|NCT01275755|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
174243|NCT01275755|E1|Reported Event|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
174244|NCT01275625|B1|Baseline|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174245|NCT01275625|P1|Participant Flow|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174246|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174247|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174248|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174249|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174250|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174251|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174252|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
175770|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
174253|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174254|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174255|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174256|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174257|NCT01275625|E1|Reported Event|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
174258|NCT01275430|B1|Baseline|Sherlock 3CG|"Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.~Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination."
174259|NCT01275430|P1|Participant Flow|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.~All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants."
174260|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
174261|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
174262|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
174263|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
174264|NCT01275430|O1|Outcome|Sherlock 3CG|Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
174265|NCT01275430|E1|Reported Event|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."
174266|NCT01275196|B3|Baseline|Total|Total of all reporting groups
174267|NCT01275196|B2|Baseline|Nilotinib|Patients received 300 mg bid (600 mg/day)
174268|NCT01275196|B1|Baseline|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174269|NCT01275196|P2|Participant Flow|Nilotinib|Patients received 300 mg bid (600 mg/day)
174270|NCT01275196|P1|Participant Flow|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174271|NCT01275196|O3|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174272|NCT01275196|O2|Outcome|CGP74588|Major metabolite of Imatinib
174273|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174274|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174275|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174276|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174277|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174278|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174279|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174280|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174281|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174282|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174283|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174284|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174285|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174286|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174287|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174288|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174289|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174290|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174291|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174292|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174293|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174294|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174295|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174296|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174297|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174298|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174299|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174300|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174301|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174302|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174303|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174304|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
174305|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174306|NCT01275196|E2|Reported Event|Nilotinib 300 mg Bid|Patients received 300 mg bid (600 mg/day)
174307|NCT01275196|E1|Reported Event|Imatinib 400 mg qd|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
174308|NCT01275131|B5|Baseline|Total|Total of all reporting groups
174309|NCT01275131|B4|Baseline|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp."
174310|NCT01275131|B3|Baseline|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp."
174311|NCT01275131|B2|Baseline|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
174312|NCT01275131|B1|Baseline|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
174313|NCT01275131|P4|Participant Flow|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp."
174314|NCT01275131|P3|Participant Flow|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp."
174315|NCT01275131|P2|Participant Flow|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
174316|NCT01275131|P1|Participant Flow|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
174317|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174318|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174319|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174320|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174321|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174322|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174323|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174324|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174325|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174326|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174327|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174328|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174329|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174330|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174331|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
174332|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174333|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174334|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174335|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174336|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174337|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174338|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174339|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174340|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174341|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174342|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
174343|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
174344|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
174345|NCT01275131|E4|Reported Event|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174346|NCT01275131|E3|Reported Event|Stage 3: Insulin Aspart|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
174347|NCT01275131|E2|Reported Event|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174348|NCT01275131|E1|Reported Event|Stage 1: Insulin Aspart|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
174349|NCT01275092|B1|Baseline|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174350|NCT01275092|P1|Participant Flow|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174351|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174352|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174353|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174354|NCT01275092|E1|Reported Event|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
174355|NCT01275066|B4|Baseline|Total|Total of all reporting groups
174356|NCT01275066|B3|Baseline|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174357|NCT01275066|B2|Baseline|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174358|NCT01275066|B1|Baseline|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174359|NCT01275066|P3|Participant Flow|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174397|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
188774|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
174360|NCT01275066|P2|Participant Flow|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174361|NCT01275066|P1|Participant Flow|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174362|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174363|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174364|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174365|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174366|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174367|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174368|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174369|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174370|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174371|NCT01275066|E3|Reported Event|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
174372|NCT01275066|E2|Reported Event|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
174373|NCT01275066|E1|Reported Event|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
174374|NCT01274897|B3|Baseline|Total|Total of all reporting groups
174375|NCT01274897|B2|Baseline|Placebo|Subjects received the saline placebo.
174376|NCT01274897|B1|Baseline|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174377|NCT01274897|P2|Participant Flow|Placebo|Subjects received the saline placebo.
174378|NCT01274897|P1|Participant Flow|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174379|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
174380|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174381|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
174382|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174383|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
174384|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174385|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
174386|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174387|NCT01274897|E2|Reported Event|Placebo|Subjects received the saline placebo.
174388|NCT01274897|E1|Reported Event|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
174389|NCT01274715|B1|Baseline|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
174390|NCT01274715|P1|Participant Flow|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
174391|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
174392|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
174393|NCT01274715|E1|Reported Event|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
174394|NCT01274611|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
174395|NCT01274611|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
174396|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
174398|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
174399|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
174400|NCT01274611|E2|Reported Event|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
174401|NCT01274611|E1|Reported Event|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
174402|NCT01274585|B3|Baseline|Total|Total of all reporting groups
174403|NCT01274585|B2|Baseline|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
174404|NCT01274585|B1|Baseline|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
174405|NCT01274585|P2|Participant Flow|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
174406|NCT01274585|P1|Participant Flow|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
174407|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
174408|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
174409|NCT01274585|E2|Reported Event|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
174410|NCT01274585|E1|Reported Event|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
174411|NCT01274559|B3|Baseline|Total|Total of all reporting groups
174412|NCT01274559|B2|Baseline|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174413|NCT01274559|B1|Baseline|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174414|NCT01274559|P2|Participant Flow|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174415|NCT01274559|P1|Participant Flow|Extended-release Niacin/Laropiprant|Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174416|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174417|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174418|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174419|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174420|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174421|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174422|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174423|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174424|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174425|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174426|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174427|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174428|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174429|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174430|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174431|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174432|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174433|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174434|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174435|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174436|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174496|NCT01273857|E1|Reported Event|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174437|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174438|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174439|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174440|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174441|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174442|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174443|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174444|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174445|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174446|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174447|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174448|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174449|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174450|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174451|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174452|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174453|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174454|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174455|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174456|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174457|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174458|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174459|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174460|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174461|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174462|NCT01274559|E2|Reported Event|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
174463|NCT01274559|E1|Reported Event|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
174464|NCT01274533|B1|Baseline|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
174465|NCT01274533|P1|Participant Flow|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
174466|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
174467|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
174468|NCT01274533|E1|Reported Event|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
174497|NCT01273818|B4|Baseline|Total|Total of all reporting groups
174498|NCT01273818|B3|Baseline|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
174469|NCT01273896|B1|Baseline|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
174470|NCT01273896|P1|Participant Flow|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
174471|NCT01273896|O1|Outcome|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
174472|NCT01273896|E1|Reported Event|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
174473|NCT01273883|B1|Baseline|Entire Study Population|Includes groups randomized to receive magnesium first and placebo first.
174474|NCT01273883|P2|Participant Flow|Placebo First, Then Magnesium|Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
174475|NCT01273883|P1|Participant Flow|Magnesium First, Then Placebo|Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
174476|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
174477|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
174478|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
174479|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
174480|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
174481|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
174482|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
174483|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
174484|NCT01273883|E2|Reported Event|Placebo|Placebo administered daily in either first intervention period or second intervention period.
174485|NCT01273883|E1|Reported Event|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
174486|NCT01273857|B3|Baseline|Total|Total of all reporting groups
174487|NCT01273857|B2|Baseline|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174488|NCT01273857|B1|Baseline|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174489|NCT01273857|P2|Participant Flow|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174490|NCT01273857|P1|Participant Flow|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174491|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174492|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174493|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174494|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174495|NCT01273857|E2|Reported Event|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
174634|NCT01272947|B3|Baseline|Total|Total of all reporting groups
174499|NCT01273818|B2|Baseline|Cephazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
174500|NCT01273818|B1|Baseline|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
174501|NCT01273818|P3|Participant Flow|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
174502|NCT01273818|P2|Participant Flow|Cefazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
174503|NCT01273818|P1|Participant Flow|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
174504|NCT01273818|O3|Outcome|Topical and iv|Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
174505|NCT01273818|O2|Outcome|Cefazolin IV|Total number of patients to which ceephazoline (İV) was applied for prophylaxis
174506|NCT01273818|O1|Outcome|Topical Gentamicin|Total number of patients to which topical gentamicin was applied for prophylaxis
174507|NCT01273818|E3|Reported Event|Gentamicin+ Cefazolin Sodium|"Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
174508|NCT01273818|E2|Reported Event|Cephazolin|"Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
174509|NCT01273818|E1|Reported Event|Gentamicin|"Gentamicin arm: application of 80 mg gentamycin topically~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
174510|NCT01273766|B4|Baseline|Total|Total of all reporting groups
174511|NCT01273766|B3|Baseline|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
174512|NCT01273766|B2|Baseline|Control Arm|blood tested on healthy patients
174513|NCT01273766|B1|Baseline|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
174514|NCT01273766|P3|Participant Flow|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
174515|NCT01273766|P2|Participant Flow|Control Arm|blood tested on healthy patients
174516|NCT01273766|P1|Participant Flow|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
174517|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
174518|NCT01273766|E3|Reported Event|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
174519|NCT01273766|E2|Reported Event|Control Arm|blood tested on healthy patients
174520|NCT01273766|E1|Reported Event|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
174521|NCT01273623|B1|Baseline|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
174522|NCT01273623|P1|Participant Flow|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
174523|NCT01273623|O1|Outcome|Study Participants|
174524|NCT01273623|O1|Outcome|Study Participants|
174525|NCT01273623|O2|Outcome|Post-atherectomy|after Jetstream use and prior to adjunctive therapies
174526|NCT01273623|O1|Outcome|Pre-atherectomy|prior to Jetstream use
174527|NCT01273623|E1|Reported Event|Study Participants|
174528|NCT01273597|B1|Baseline|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174529|NCT01273597|P1|Participant Flow|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174530|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174531|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174532|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174533|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174534|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174535|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174536|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174537|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174635|NCT01272947|B2|Baseline|Placebo|
174636|NCT01272947|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
174637|NCT01272947|P2|Participant Flow|Placebo|
174538|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174539|NCT01273597|E1|Reported Event|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
174540|NCT01273519|B4|Baseline|Total|Total of all reporting groups
174541|NCT01273519|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174542|NCT01273519|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174543|NCT01273519|B1|Baseline|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174544|NCT01273519|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174545|NCT01273519|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174546|NCT01273519|P1|Participant Flow|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174547|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174548|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174549|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174550|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174551|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174552|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174553|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174554|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174555|NCT01273519|O1|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174556|NCT01273519|O1|Outcome|PsA, AS|Participants with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174557|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174558|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174559|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174560|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174561|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174562|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174563|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174638|NCT01272947|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
174639|NCT01272947|O2|Outcome|Placebo|
174640|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
174564|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174565|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174566|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174567|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174568|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174569|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174570|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174571|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174572|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174573|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174574|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174575|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174576|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174577|NCT01273519|E1|Reported Event|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
174578|NCT01273181|B5|Baseline|Total|Total of all reporting groups
174579|NCT01273181|B4|Baseline|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174580|NCT01273181|B3|Baseline|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174581|NCT01273181|B2|Baseline|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174582|NCT01273181|B1|Baseline|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174583|NCT01273181|P4|Participant Flow|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
174584|NCT01273181|P3|Participant Flow|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
174585|NCT01273181|P2|Participant Flow|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174641|NCT01272947|O2|Outcome|Placebo|
174642|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
174643|NCT01272947|E2|Reported Event|Placebo|
174586|NCT01273181|P1|Participant Flow|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174587|NCT01273181|O4|Outcome|Anti-MAGE TCR PBL +HD IL-2, Other|"anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174588|NCT01273181|O3|Outcome|Anti-MAGE TCR PBL+HD IL-2, Mel, RCC|"anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174589|NCT01273181|O2|Outcome|Anti-MAGE TCR PBL 5x10e10 +HD IL-2|"anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174590|NCT01273181|O1|Outcome|Anti-MAGE TCR PBL 5x10e9 +HD IL-2|"anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174591|NCT01273181|O4|Outcome|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174592|NCT01273181|O3|Outcome|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174593|NCT01273181|O2|Outcome|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174594|NCT01273181|O1|Outcome|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174595|NCT01273181|E4|Reported Event|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174596|NCT01273181|E3|Reported Event|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174597|NCT01273181|E2|Reported Event|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174598|NCT01273181|E1|Reported Event|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
174599|NCT01273064|B6|Baseline|Total|Total of all reporting groups
174600|NCT01273064|B5|Baseline|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
174601|NCT01273064|B4|Baseline|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
174602|NCT01273064|B3|Baseline|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
174603|NCT01273064|B2|Baseline|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
174604|NCT01273064|B1|Baseline|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
174644|NCT01272947|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
174645|NCT01272934|B3|Baseline|Total|Total of all reporting groups
174646|NCT01272934|B2|Baseline|Placebo|Placebo : Topical gel-4 times daily
174647|NCT01272934|B1|Baseline|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
174605|NCT01273064|P5|Participant Flow|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
174606|NCT01273064|P4|Participant Flow|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
174607|NCT01273064|P3|Participant Flow|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
174608|NCT01273064|P2|Participant Flow|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
174609|NCT01273064|P1|Participant Flow|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
174610|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
174611|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
174612|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
174613|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
174614|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
174615|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
174616|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
174617|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
174618|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
174619|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
174620|NCT01273064|E5|Reported Event|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
174621|NCT01273064|E4|Reported Event|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
174622|NCT01273064|E3|Reported Event|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
174623|NCT01273064|E2|Reported Event|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
174624|NCT01273064|E1|Reported Event|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
174625|NCT01273038|B3|Baseline|Total|Total of all reporting groups
174626|NCT01273038|B2|Baseline|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
174627|NCT01273038|B1|Baseline|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
174628|NCT01273038|P2|Participant Flow|SenSura First (Reference Filter), Then Morfeus (Test Filter)|First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
174629|NCT01273038|P1|Participant Flow|Morfeus First (Test Filter), Then SenSura (Reference Filter)|First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)
174630|NCT01273038|O2|Outcome|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
174631|NCT01273038|O1|Outcome|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
174632|NCT01273038|E2|Reported Event|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
174633|NCT01273038|E1|Reported Event|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
174649|NCT01272934|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
174650|NCT01272934|O2|Outcome|Placebo|
174651|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
174652|NCT01272934|O2|Outcome|Placebo|Placebo : Topical gel-4 times daily
174653|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
174654|NCT01272934|E2|Reported Event|Placebo|Placebo : Topical gel-4 times daily
174655|NCT01272934|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
174656|NCT01272921|B3|Baseline|Total|Total of all reporting groups
174657|NCT01272921|B2|Baseline|GROUP 2|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
174658|NCT01272921|B1|Baseline|GROUP 1|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
174659|NCT01272921|P2|Participant Flow|Ropivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
174660|NCT01272921|P1|Participant Flow|Bupivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
174661|NCT01272921|O2|Outcome|Ropivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
174662|NCT01272921|O1|Outcome|Bupivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
174663|NCT01272921|O2|Outcome|Below CIEL|The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
174664|NCT01272921|O1|Outcome|Above CIEL|The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).
174665|NCT01272921|E2|Reported Event|GROUP 2|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
174666|NCT01272921|E1|Reported Event|GROUP 1|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
174667|NCT01272908|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174668|NCT01272908|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.
174669|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174670|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174671|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174672|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174698|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
175771|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
174673|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174674|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174675|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174676|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174677|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174678|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174679|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174680|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174681|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174682|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174683|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174684|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174742|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174743|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174744|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174745|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174685|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174686|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174687|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174688|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174689|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174690|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174691|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174692|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174693|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174694|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174695|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174696|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174697|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174746|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
191569|NCT01218438|O2|Outcome|Subcutaneous 20%|
174699|NCT01272908|E2|Reported Event|Re-treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
174700|NCT01272908|E1|Reported Event|Initial Treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
174701|NCT01272882|B1|Baseline|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
174702|NCT01272882|P1|Participant Flow|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
174703|NCT01272882|O1|Outcome|Adults With ARDS or ALI|Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
174704|NCT01272882|E1|Reported Event|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
174705|NCT01272869|B3|Baseline|Total|Total of all reporting groups
174706|NCT01272869|B2|Baseline|Morfeus|The test product is the product with the proposed new filter (Morfeus)
174707|NCT01272869|B1|Baseline|Sensura|The reference product is the SenSura product which is already commercially available
174708|NCT01272869|P2|Participant Flow|Morfeus First; Then Sensura|The test product with the Morfeus filter is the test product with the proposed new filter.
174709|NCT01272869|P1|Participant Flow|Sensura First; Then Morfeus|The reference product is the SenSura product which is already commercially available
174710|NCT01272869|O2|Outcome|Morfeus|The test product is the product with the proposed new filter (Morfeus)
174711|NCT01272869|O1|Outcome|Sensura|SenSura is the reference product and the product is already commercially available
174712|NCT01272869|E2|Reported Event|Morfeus|The test product is the product with the proposed new filter (Morfeus)
174713|NCT01272869|E1|Reported Event|Sensura|The reference product is the SenSura product which is already commercially available
174714|NCT01272804|B7|Baseline|Total|Total of all reporting groups
174715|NCT01272804|B6|Baseline|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174716|NCT01272804|B5|Baseline|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174717|NCT01272804|B4|Baseline|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174718|NCT01272804|B3|Baseline|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174719|NCT01272804|B2|Baseline|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174720|NCT01272804|B1|Baseline|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174721|NCT01272804|P6|Participant Flow|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174722|NCT01272804|P5|Participant Flow|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174723|NCT01272804|P4|Participant Flow|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174724|NCT01272804|P3|Participant Flow|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174725|NCT01272804|P2|Participant Flow|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174726|NCT01272804|P1|Participant Flow|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174727|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174728|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174729|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174730|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174731|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174732|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174733|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174734|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174735|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174736|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174737|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174738|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174739|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174740|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174741|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174747|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174748|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174749|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174750|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174751|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174752|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174753|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174754|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174755|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174756|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174757|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174758|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174759|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174760|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174761|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174762|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174763|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174764|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174765|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174766|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174767|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174768|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174769|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174770|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174771|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174772|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174773|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174774|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174775|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174776|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174777|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174778|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174779|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174780|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174781|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174782|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174783|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174784|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174785|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174786|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174787|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174788|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174789|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174790|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174791|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174792|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174793|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174794|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174795|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174796|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174797|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174798|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174799|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174800|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174801|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174802|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174803|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174804|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174805|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174806|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174807|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174808|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174809|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174810|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174811|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174812|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174813|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174814|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174815|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174816|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174817|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174818|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174819|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174820|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174821|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174822|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174823|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174824|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174825|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174826|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174827|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174828|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174829|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174830|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174831|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174832|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174833|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174834|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174835|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174836|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174837|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174838|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174839|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174840|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174841|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174842|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174843|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174941|NCT01272583|O2|Outcome|Sitagliptin Treatment|
174844|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174845|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174846|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174847|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174848|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174849|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174850|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174851|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174852|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174853|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174854|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174855|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174856|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174857|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174858|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174859|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174860|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174861|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174862|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174863|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174864|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174865|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174866|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174867|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174868|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174869|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174870|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174871|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174872|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174873|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174874|NCT01272804|E6|Reported Event|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
174875|NCT01272804|E5|Reported Event|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
174876|NCT01272804|E4|Reported Event|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
174877|NCT01272804|E3|Reported Event|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
174878|NCT01272804|E2|Reported Event|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
174879|NCT01272804|E1|Reported Event|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
174880|NCT01272661|B4|Baseline|Total|Total of all reporting groups
174881|NCT01272661|B3|Baseline|Enhanced Curriculum+Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174882|NCT01272661|B2|Baseline|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174883|NCT01272661|B1|Baseline|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174884|NCT01272661|P3|Participant Flow|Enhanced Curriculum +Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174942|NCT01272583|O1|Outcome|Baseline|
174885|NCT01272661|P2|Participant Flow|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174886|NCT01272661|P1|Participant Flow|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174887|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174888|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174889|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174890|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174891|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174892|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174893|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174894|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174895|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174896|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174897|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174898|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174899|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174900|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174901|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174943|NCT01272583|O3|Outcome|Placebo|
174944|NCT01272583|O2|Outcome|Sitagliptin Treatment|
174945|NCT01272583|O1|Outcome|Baseline|
174946|NCT01272583|O3|Outcome|Placebo|
174947|NCT01272583|O2|Outcome|Sitagliptin Treatment|
174902|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174903|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174904|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174905|NCT01272661|E3|Reported Event|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
174906|NCT01272661|E2|Reported Event|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
174907|NCT01272661|E1|Reported Event|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
174908|NCT01272635|B3|Baseline|Total|Total of all reporting groups
174909|NCT01272635|B2|Baseline|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174910|NCT01272635|B1|Baseline|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174911|NCT01272635|P4|Participant Flow|Placebo/Placebo|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
174912|NCT01272635|P3|Participant Flow|Placebo/Prednisolone|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
174913|NCT01272635|P2|Participant Flow|Azithromycin/Placebo|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
174914|NCT01272635|P1|Participant Flow|Azithromycin/Prednisolone|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
174915|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174916|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174917|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174918|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174919|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174920|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174921|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174922|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174923|NCT01272635|O2|Outcome|Placebo|Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
174924|NCT01272635|O1|Outcome|Prednisone|Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
174925|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174926|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174927|NCT01272635|E2|Reported Event|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174928|NCT01272635|E1|Reported Event|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
174929|NCT01272583|B3|Baseline|Total|Total of all reporting groups
174930|NCT01272583|B2|Baseline|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
174931|NCT01272583|B1|Baseline|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
174932|NCT01272583|P2|Participant Flow|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
174933|NCT01272583|P1|Participant Flow|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
174934|NCT01272583|O3|Outcome|Placebo|
174935|NCT01272583|O2|Outcome|Sitagliptin Treatment|
174936|NCT01272583|O1|Outcome|Baseline|
174937|NCT01272583|O3|Outcome|Placebo|
174938|NCT01272583|O2|Outcome|Sitagliptin Treatment|
174939|NCT01272583|O1|Outcome|Baseline|
174940|NCT01272583|O3|Outcome|Placebo|
174962|NCT01272284|P1|Participant Flow|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174963|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174964|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174965|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174966|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174967|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174968|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174969|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174970|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174971|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174972|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174973|NCT01272284|O1|Outcome|Altis SIS®|Participants implanted with Altis® Single Incision Sling
174974|NCT01272284|E1|Reported Event|Altis® SIS|Participants implanted with Altis® Single Incision Sling
174975|NCT01272232|B4|Baseline|Total|Total of all reporting groups
174976|NCT01272232|B3|Baseline|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174977|NCT01272232|B2|Baseline|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174978|NCT01272232|B1|Baseline|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174979|NCT01272232|P3|Participant Flow|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174980|NCT01272232|P2|Participant Flow|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174981|NCT01272232|P1|Participant Flow|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174982|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174983|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174984|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174985|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175047|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
174986|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174987|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174988|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174989|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174990|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174991|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174992|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174993|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174994|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174995|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174996|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174997|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
174998|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175102|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
174999|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175000|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175001|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175002|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175003|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175004|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175005|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175006|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175007|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175008|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175009|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175010|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175011|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175103|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
175012|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175013|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175014|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175015|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175016|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175017|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175018|NCT01272232|E3|Reported Event|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175019|NCT01272232|E2|Reported Event|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175020|NCT01272232|E1|Reported Event|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
175021|NCT01272219|B5|Baseline|Total|Total of all reporting groups
175022|NCT01272219|B4|Baseline|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175023|NCT01272219|B3|Baseline|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175024|NCT01272219|B2|Baseline|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175025|NCT01272219|B1|Baseline|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175026|NCT01272219|P6|Participant Flow|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175772|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175027|NCT01272219|P5|Participant Flow|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175028|NCT01272219|P4|Participant Flow|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175029|NCT01272219|P3|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175030|NCT01272219|P2|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175031|NCT01272219|P1|Participant Flow|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175032|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175033|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175034|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175035|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175036|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175037|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
175038|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175039|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175040|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175041|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175042|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175043|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175044|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175045|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175046|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175773|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175048|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175049|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175050|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175051|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
175052|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175053|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175054|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175055|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175056|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175057|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
175058|NCT01272219|E4|Reported Event|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175059|NCT01272219|E3|Reported Event|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
175060|NCT01272219|E2|Reported Event|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175061|NCT01272219|E1|Reported Event|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
175062|NCT01272193|B3|Baseline|Total|Total of all reporting groups
175063|NCT01272193|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175064|NCT01272193|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175065|NCT01272193|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175066|NCT01272193|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175067|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175068|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175069|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
191570|NCT01218438|O1|Outcome|Intravenous 10%|
175070|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175071|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175072|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175073|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175074|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175075|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175076|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175077|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175078|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175079|NCT01272193|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
175080|NCT01272193|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
175081|NCT01272180|B5|Baseline|Total|Total of all reporting groups
175082|NCT01272180|B4|Baseline|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175083|NCT01272180|B3|Baseline|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
175084|NCT01272180|B2|Baseline|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175085|NCT01272180|B1|Baseline|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175086|NCT01272180|P4|Participant Flow|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175087|NCT01272180|P3|Participant Flow|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
175088|NCT01272180|P2|Participant Flow|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175089|NCT01272180|P1|Participant Flow|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175090|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175091|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175092|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175093|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
175094|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175095|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175096|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175097|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
175098|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175099|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175100|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
175101|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
191571|NCT01218438|O2|Outcome|Subcutaneous 20%|
175104|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175105|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175106|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
175107|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175108|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175109|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
175110|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175111|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175112|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175113|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175114|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175115|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175116|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175117|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175118|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
175119|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
175120|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
175121|NCT01272180|E4|Reported Event|ACWY|Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
175122|NCT01272180|E3|Reported Event|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
175123|NCT01272180|E2|Reported Event|ABCWY+qOMV|"Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)~+and MenACWY combination vaccine, administered two months apart."
175124|NCT01272180|E1|Reported Event|ABCWY+OMV|Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.
175125|NCT01272141|B1|Baseline|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
175126|NCT01272141|P1|Participant Flow|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
175127|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
175128|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
175129|NCT01272141|E1|Reported Event|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
175130|NCT01272076|B1|Baseline|GA Group|Patients diagnosed with dry AMD and geographic atrophy
175131|NCT01272076|P1|Participant Flow|Dry AMD With Geographic Atrophy|Patients diagnosed with dry AMD and geographic atrophy
175132|NCT01272076|O1|Outcome|GA Group|Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
175133|NCT01272076|E1|Reported Event|GA Group|Patients with dry age related macular degeneration and geographic atrophy.
175134|NCT01272011|B4|Baseline|Total|Total of all reporting groups
175135|NCT01272011|B3|Baseline|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
175136|NCT01272011|B2|Baseline|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
175137|NCT01272011|B1|Baseline|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
175138|NCT01272011|P3|Participant Flow|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
175139|NCT01272011|P2|Participant Flow|Phase 2 Arm (LTF)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
175140|NCT01272011|P1|Participant Flow|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
175141|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
175142|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
175179|NCT01271907|P3|Participant Flow|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
175506|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175143|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
175144|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
175145|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
175146|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
175147|NCT01272011|E3|Reported Event|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
175148|NCT01272011|E2|Reported Event|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
175149|NCT01272011|E1|Reported Event|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
175150|NCT01271946|B3|Baseline|Total|Total of all reporting groups
175151|NCT01271946|B2|Baseline|Sheath Greater Than 6F|
175152|NCT01271946|B1|Baseline|Intent to Treat|
175153|NCT01271946|P2|Participant Flow|Sheath Greater Than 6 French (F)|Subjects in whom the procedural sheath was upsized to greater than 6F.
175154|NCT01271946|P1|Participant Flow|Intent to Treat (ITT)|The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.
175155|NCT01271946|O1|Outcome|Per Protocol|Time to Ambulation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
175156|NCT01271946|O1|Outcome|Per Protocol|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175157|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
175158|NCT01271946|O1|Outcome|Intent to Treat|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
175159|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175160|NCT01271946|O1|Outcome|Intent to Treat|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175161|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
175162|NCT01271946|O1|Outcome|Intent to Treat|Time to Actual Discharge was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175163|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
175164|NCT01271946|O1|Outcome|Group 1|Time to Discharge Eligibility was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175165|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175166|NCT01271946|O1|Outcome|Intent to Treat|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
175167|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Minor access site-related complications observed in subjects who were upsized to sheath size greater than 6F.
175168|NCT01271946|O1|Outcome|Group 1|Minor access site-related complications observed in the intent-to-treat population.
175169|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
175170|NCT01271946|O1|Outcome|Intent to Treat|
175171|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Major access site-related complications observed in subjects treated with sheath size greater than 6F.
175172|NCT01271946|O1|Outcome|Intent to Treat|Major access site-related complications observed in the intent-to-treat population.
175173|NCT01271946|E2|Reported Event|Sheath Greater Than 6F|
175174|NCT01271946|E1|Reported Event|Intent to Treat|
175175|NCT01271907|B4|Baseline|Total|Total of all reporting groups
175176|NCT01271907|B3|Baseline|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
175177|NCT01271907|B2|Baseline|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175178|NCT01271907|B1|Baseline|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175397|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175180|NCT01271907|P2|Participant Flow|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175181|NCT01271907|P1|Participant Flow|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175182|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
175183|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175184|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175185|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
175186|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175187|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175188|NCT01271907|E3|Reported Event|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
175189|NCT01271907|E2|Reported Event|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175190|NCT01271907|E1|Reported Event|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
175191|NCT01271803|B13|Baseline|Total|Total of all reporting groups
175192|NCT01271803|B12|Baseline|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175193|NCT01271803|B11|Baseline|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175194|NCT01271803|B10|Baseline|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175195|NCT01271803|B9|Baseline|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175196|NCT01271803|B8|Baseline|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175197|NCT01271803|B7|Baseline|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175198|NCT01271803|B6|Baseline|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175199|NCT01271803|B5|Baseline|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175200|NCT01271803|B4|Baseline|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175201|NCT01271803|B3|Baseline|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175398|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175202|NCT01271803|B2|Baseline|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175203|NCT01271803|B1|Baseline|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175204|NCT01271803|P12|Participant Flow|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175205|NCT01271803|P11|Participant Flow|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175206|NCT01271803|P10|Participant Flow|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175207|NCT01271803|P9|Participant Flow|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175208|NCT01271803|P8|Participant Flow|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175209|NCT01271803|P7|Participant Flow|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175210|NCT01271803|P6|Participant Flow|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175211|NCT01271803|P5|Participant Flow|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175212|NCT01271803|P4|Participant Flow|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-28 (28/0 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175213|NCT01271803|P3|Participant Flow|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175214|NCT01271803|P2|Participant Flow|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-21, followed by 7 days off on Days 22-28 (21/7 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175215|NCT01271803|P1|Participant Flow|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 milligrams (mg) cobimetinib once daily (QD) on Days 1-14, followed by 14 days off on Days 15-28 (14/14 dosing schedule) and oral 720 mg vemurafenib twice daily (BID) on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175216|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175217|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175218|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175219|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175220|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175507|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175221|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175222|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175223|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175224|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175225|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175226|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175227|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175228|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175229|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175230|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175231|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175232|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175233|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175234|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175235|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175236|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175237|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175238|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175239|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175399|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175240|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175241|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175242|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175243|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175244|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175245|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175246|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175247|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175248|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175249|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175250|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175251|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175252|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175253|NCT01271803|O5|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175254|NCT01271803|O4|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175255|NCT01271803|O3|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175256|NCT01271803|O2|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175257|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175258|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175259|NCT01271803|O7|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175260|NCT01271803|O6|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175261|NCT01271803|O5|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175262|NCT01271803|O4|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175263|NCT01271803|O3|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175264|NCT01271803|O2|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175265|NCT01271803|O1|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175266|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175267|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175268|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175269|NCT01271803|O7|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175270|NCT01271803|O6|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175271|NCT01271803|O5|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175272|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175273|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175274|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175275|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175276|NCT01271803|O2|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175277|NCT01271803|O1|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175278|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175279|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175280|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175281|NCT01271803|O5|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175282|NCT01271803|O4|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175283|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175284|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175285|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175286|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175287|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175288|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175289|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175290|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175291|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175292|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175293|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175294|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175295|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175296|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175297|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175298|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175299|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175300|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175301|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175302|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175303|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175304|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175305|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175306|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175307|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175308|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175309|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175310|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175311|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175312|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175313|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175314|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175315|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175316|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175317|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175318|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175319|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175320|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175321|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175322|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175323|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175324|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175325|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175326|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175327|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175328|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175329|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175330|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175331|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175332|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175333|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175334|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175335|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175336|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175337|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175338|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175339|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175340|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175341|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175342|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175343|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175344|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175345|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175346|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175347|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175348|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175349|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175350|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175351|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175352|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175353|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175354|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175355|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175356|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175357|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175358|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175359|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175360|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175361|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175362|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175363|NCT01271803|O1|Outcome|Dose Escalation Stage (Stage 1)|All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
175364|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175365|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175366|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175367|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175368|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175369|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175370|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175371|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175760|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175372|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175373|NCT01271803|E12|Reported Event|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175374|NCT01271803|E11|Reported Event|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175375|NCT01271803|E10|Reported Event|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175376|NCT01271803|E9|Reported Event|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175377|NCT01271803|E8|Reported Event|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175378|NCT01271803|E7|Reported Event|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175379|NCT01271803|E6|Reported Event|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175380|NCT01271803|E5|Reported Event|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175381|NCT01271803|E4|Reported Event|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175382|NCT01271803|E3|Reported Event|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175383|NCT01271803|E2|Reported Event|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175384|NCT01271803|E1|Reported Event|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
175385|NCT01271712|B3|Baseline|Total|Total of all reporting groups
175386|NCT01271712|B2|Baseline|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175387|NCT01271712|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175388|NCT01271712|P2|Participant Flow|Placebo First, Then Option of Open Label Regorafenib Treatment|Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
175389|NCT01271712|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175390|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175391|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175392|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175393|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175394|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175395|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175396|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175400|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175401|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175402|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175403|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175404|NCT01271712|E4|Reported Event|Placebo, Open Label Only (Switch to Regorafenib)|Switch to Regorafenib (Open Label study phase only): Participants switched to Open label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175405|NCT01271712|E3|Reported Event|Regorafenib, Open Label Only (Regorafenib Continued)|Continue Regorafenib (Open Label study phase only): Participants continue to receive Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175406|NCT01271712|E2|Reported Event|Placebo ( Double Blind Only)|Placebo (Double Blind study phase only): Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175407|NCT01271712|E1|Reported Event|Regorafenib (Double Blind Only)|Regorafenib (Double Blind study phase only): Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
175408|NCT01271686|B1|Baseline|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
175409|NCT01271686|P1|Participant Flow|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
175410|NCT01271686|O1|Outcome|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
175411|NCT01271686|E1|Reported Event|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
175412|NCT01271543|B3|Baseline|Total|Total of all reporting groups
175413|NCT01271543|B2|Baseline|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175414|NCT01271543|B1|Baseline|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175415|NCT01271543|P2|Participant Flow|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175416|NCT01271543|P1|Participant Flow|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175417|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175418|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175419|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175420|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175421|NCT01271543|E2|Reported Event|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175422|NCT01271543|E1|Reported Event|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
175423|NCT01271452|B3|Baseline|Total|Total of all reporting groups
175424|NCT01271452|B2|Baseline|Bocouture®|botulinum toxin type A (Bocouture®)
175425|NCT01271452|B1|Baseline|Vistabel®|botulinum toxin type A (Vistabel®)
175426|NCT01271452|P2|Participant Flow|Bocouture®|botulinum toxin type A (Bocouture®)
175427|NCT01271452|P1|Participant Flow|Vistabel®|botulinum toxin type A (Vistabel®)
175428|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175429|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175430|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175431|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175432|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175433|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175434|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175435|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175436|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175437|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175438|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175439|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175440|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175441|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175442|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
175443|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
175444|NCT01271452|E2|Reported Event|Bocouture®|botulinum toxin type A (Bocouture®)
175445|NCT01271452|E1|Reported Event|Vistabel®|botulinum toxin type A (Vistabel®)
175446|NCT01271413|B3|Baseline|Total|Total of all reporting groups
175447|NCT01271413|B2|Baseline|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175448|NCT01271413|B1|Baseline|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175449|NCT01271413|P2|Participant Flow|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175450|NCT01271413|P1|Participant Flow|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175451|NCT01271413|O2|Outcome|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175452|NCT01271413|O1|Outcome|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175453|NCT01271413|E2|Reported Event|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175454|NCT01271413|E1|Reported Event|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
175455|NCT01271244|B3|Baseline|Total|Total of all reporting groups
175456|NCT01271244|B2|Baseline|Major Depression Group|Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
175457|NCT01271244|B1|Baseline|PTSD Depression Group|Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks
175458|NCT01271244|P2|Participant Flow|Major Depression Group|Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
175459|NCT01271244|P1|Participant Flow|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
175460|NCT01271244|O2|Outcome|Major Depression Group|Veterans with major depression onny receive Escitalopram: 10-20mg daily for 12 weeks
175461|NCT01271244|O1|Outcome|PTSD Depression Group|Veterans with PTSD and depession will receive Escitalopram: 10-20mg daily for 12 weeks
175462|NCT01271244|E2|Reported Event|Major Depression Group|Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
175463|NCT01271244|E1|Reported Event|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
175464|NCT01271036|B3|Baseline|Total|Total of all reporting groups
175465|NCT01271036|B2|Baseline|Female|Female Participants
175466|NCT01271036|B1|Baseline|Male|Male Participants
175467|NCT01271036|P2|Participant Flow|Female|Female Participants (K-Y Brand TOUCH 2-in-1)
175468|NCT01271036|P1|Participant Flow|Males|Male Participants (K-Y Brand TOUCH 2-in-1)
175469|NCT01271036|O2|Outcome|Female|Female Participants
175470|NCT01271036|O1|Outcome|Male|Male Participants
175471|NCT01271036|O2|Outcome|Female|Female Participants
175472|NCT01271036|O1|Outcome|Male|Male Participants
175473|NCT01271036|O2|Outcome|Female|Female Participants
175474|NCT01271036|O1|Outcome|Male|Male Participants
175475|NCT01271036|O2|Outcome|Female|Female Participants
175476|NCT01271036|O1|Outcome|Male|Male Participants
175477|NCT01271036|O2|Outcome|Female|Female Participants
175478|NCT01271036|O1|Outcome|Male|Male Participants
175479|NCT01271036|E2|Reported Event|Female|Female Participants
175480|NCT01271036|E1|Reported Event|Male|Male Participants
175481|NCT01270971|B3|Baseline|Total|Total of all reporting groups
175482|NCT01270971|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175483|NCT01270971|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175484|NCT01270971|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175485|NCT01270971|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175486|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175487|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175488|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175489|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175490|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175491|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175492|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175493|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175494|NCT01270971|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
175495|NCT01270971|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
175496|NCT01270958|B1|Baseline|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175497|NCT01270958|P1|Participant Flow|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175498|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175499|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175500|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175501|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175502|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175503|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175504|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175505|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175508|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175509|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175510|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175511|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175512|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175513|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175514|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175515|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175516|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175517|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175518|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175519|NCT01270958|E1|Reported Event|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
175520|NCT01270919|B1|Baseline|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
175521|NCT01270919|P1|Participant Flow|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
175522|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
175523|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
175524|NCT01270919|E1|Reported Event|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
175525|NCT01270880|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
175526|NCT01270880|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
175527|NCT01270880|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
175528|NCT01270880|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
175529|NCT01270867|B3|Baseline|Total|Total of all reporting groups
175530|NCT01270867|B2|Baseline|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
175531|NCT01270867|B1|Baseline|Merci Retriever|Patients who were randomized to the Merci Retriever
175532|NCT01270867|P2|Participant Flow|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
175533|NCT01270867|P1|Participant Flow|Merci Retriever|Patients who were randomized to the Merci Retriever
175534|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175535|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175536|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175537|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175538|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175539|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175540|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175541|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175542|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175543|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175544|NCT01270867|E2|Reported Event|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
175545|NCT01270867|E1|Reported Event|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
175546|NCT01270841|B5|Baseline|Total|Total of all reporting groups
175547|NCT01270841|B4|Baseline|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175548|NCT01270841|B3|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175549|NCT01270841|B2|Baseline|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175550|NCT01270841|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175551|NCT01270841|P4|Participant Flow|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175552|NCT01270841|P3|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175553|NCT01270841|P2|Participant Flow|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175554|NCT01270841|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175555|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175556|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175557|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175558|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175559|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175560|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175561|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175562|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175563|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175564|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175565|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175566|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175567|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175568|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175761|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175569|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175570|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175571|NCT01270841|E4|Reported Event|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175572|NCT01270841|E3|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
175573|NCT01270841|E2|Reported Event|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
175574|NCT01270841|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
175575|NCT01270828|B3|Baseline|Total|Total of all reporting groups
175576|NCT01270828|B2|Baseline|Placebo DB|Participants received matching placebo
175577|NCT01270828|B1|Baseline|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175578|NCT01270828|P3|Participant Flow|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
175579|NCT01270828|P2|Participant Flow|Placebo DB|Participants received matching placebo
175580|NCT01270828|P1|Participant Flow|Pregabalin Controlled Release (CR) DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175581|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175582|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175583|NCT01270828|O3|Outcome|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
175584|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175585|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175586|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175587|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175588|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175589|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175590|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175591|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175592|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175593|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175594|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175595|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175596|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175597|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175598|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175599|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175600|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175601|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175602|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175603|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175604|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175605|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175606|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175607|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175608|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175609|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175610|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175611|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175612|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175613|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175614|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
175615|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175616|NCT01270828|E3|Reported Event|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
175617|NCT01270828|E2|Reported Event|Placebo DB|Participants received matching placebo
175618|NCT01270828|E1|Reported Event|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
175619|NCT01270802|B3|Baseline|Total|Total of all reporting groups
175620|NCT01270802|B2|Baseline|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
175621|NCT01270802|B1|Baseline|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
175622|NCT01270802|P2|Participant Flow|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
175623|NCT01270802|P1|Participant Flow|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
175624|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/efavirenz will be switched to tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
175625|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
175626|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
175627|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
175628|NCT01270802|E2|Reported Event|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
175629|NCT01270802|E1|Reported Event|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
175630|NCT01270711|B9|Baseline|Total|Total of all reporting groups
175631|NCT01270711|B8|Baseline|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
175632|NCT01270711|B7|Baseline|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175633|NCT01270711|B6|Baseline|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
175762|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175634|NCT01270711|B5|Baseline|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175635|NCT01270711|B4|Baseline|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175636|NCT01270711|B3|Baseline|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175637|NCT01270711|B2|Baseline|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175638|NCT01270711|B1|Baseline|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175639|NCT01270711|P8|Participant Flow|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
175640|NCT01270711|P7|Participant Flow|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175641|NCT01270711|P6|Participant Flow|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
175642|NCT01270711|P5|Participant Flow|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175643|NCT01270711|P4|Participant Flow|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175644|NCT01270711|P3|Participant Flow|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175645|NCT01270711|P2|Participant Flow|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175646|NCT01270711|P1|Participant Flow|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175647|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
175648|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175649|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
175650|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
175651|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175652|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
175653|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
175654|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175655|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
191572|NCT01218438|O1|Outcome|Intravenous 10%|
175656|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175657|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175658|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175659|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175660|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175661|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175662|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175663|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175664|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175665|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175666|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175667|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175668|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175669|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175670|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175671|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175672|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175673|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175763|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175764|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175674|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175675|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175676|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175677|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175678|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175679|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175680|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175681|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175682|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175683|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175684|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175685|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175686|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175687|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175688|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175689|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175690|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175691|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175692|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
191573|NCT01218438|O2|Outcome|Subcutaneous 20%|
175693|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175694|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175695|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175696|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175697|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175698|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175699|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175700|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175701|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175702|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175703|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175704|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175705|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175706|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175707|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175708|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175709|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175710|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175711|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
191574|NCT01218438|O1|Outcome|Intravenous 10%|
175712|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175713|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175714|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175715|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175716|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175717|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175718|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175719|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175720|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175721|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175722|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175723|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175724|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175725|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175726|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175727|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175728|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175729|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175765|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175766|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175767|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175730|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175731|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175732|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175733|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175734|NCT01270711|E8|Reported Event|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
175735|NCT01270711|E7|Reported Event|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
175736|NCT01270711|E6|Reported Event|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
175737|NCT01270711|E5|Reported Event|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
175738|NCT01270711|E4|Reported Event|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
175739|NCT01270711|E3|Reported Event|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
175740|NCT01270711|E2|Reported Event|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
175741|NCT01270711|E1|Reported Event|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
175742|NCT01270620|B3|Baseline|Total|Total of all reporting groups
175743|NCT01270620|B2|Baseline|Propofol|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
175744|NCT01270620|B1|Baseline|Desflurane|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
175745|NCT01270620|P2|Participant Flow|Propofol Group|"Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.~Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175746|NCT01270620|P1|Participant Flow|Desflurane Group|"Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.~Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175747|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175748|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175749|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175750|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175751|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175752|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175753|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175754|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175755|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175756|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175757|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
175758|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
175759|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
191575|NCT01218438|O2|Outcome|Subcutaneous 20%|
175774|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175775|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175776|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175777|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175778|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175779|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175780|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175781|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175782|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175783|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175784|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175785|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
175786|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
175787|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
175788|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
175789|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
175790|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
175791|NCT01270620|O2|Outcome|Propofol|"Patients received propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175792|NCT01270620|O1|Outcome|Desflurane|"Patients received desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175793|NCT01270620|E2|Reported Event|Propofol|"Patients will receive propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175794|NCT01270620|E1|Reported Event|Desflurane|"Patients will receive desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
175795|NCT01270581|B3|Baseline|Total|Total of all reporting groups
175796|NCT01270581|B2|Baseline|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
175797|NCT01270581|B1|Baseline|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
175798|NCT01270581|P2|Participant Flow|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
175799|NCT01270581|P1|Participant Flow|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
175800|NCT01270581|O2|Outcome|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
175857|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
176026|NCT01268943|B4|Baseline|1500mg|capecitabine 750mg/m2 twice daily. 6 patients enrolled
175801|NCT01270581|O1|Outcome|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
175802|NCT01270581|E2|Reported Event|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
175803|NCT01270581|E1|Reported Event|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
175804|NCT01270555|B1|Baseline|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175805|NCT01270555|P1|Participant Flow|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175806|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175807|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175808|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175809|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175810|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175811|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175812|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175813|NCT01270555|E1|Reported Event|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
175814|NCT01270529|B4|Baseline|Total|Total of all reporting groups
175815|NCT01270529|B3|Baseline|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175816|NCT01270529|B2|Baseline|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175817|NCT01270529|B1|Baseline|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175818|NCT01270529|P3|Participant Flow|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175819|NCT01270529|P2|Participant Flow|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175820|NCT01270529|P1|Participant Flow|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175858|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175859|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
176027|NCT01268943|B3|Baseline|1400mg|capecitabine 700mg/m2 twice daily. 3 patients enrolled
175821|NCT01270529|O3|Outcome|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175822|NCT01270529|O2|Outcome|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175823|NCT01270529|O1|Outcome|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175824|NCT01270529|E3|Reported Event|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175825|NCT01270529|E2|Reported Event|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175826|NCT01270529|E1|Reported Event|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
175827|NCT01270503|B1|Baseline|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
175828|NCT01270503|P1|Participant Flow|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
175829|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants received a single dose of Menactra vaccine
175830|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
175831|NCT01270503|E1|Reported Event|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
175832|NCT01270464|B4|Baseline|Total|Total of all reporting groups
175833|NCT01270464|B3|Baseline|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175834|NCT01270464|B2|Baseline|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175835|NCT01270464|B1|Baseline|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175836|NCT01270464|P3|Participant Flow|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175837|NCT01270464|P2|Participant Flow|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175838|NCT01270464|P1|Participant Flow|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175839|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175840|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175841|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175842|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175843|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175844|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175845|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175846|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175847|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175848|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175849|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175850|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175851|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175852|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175853|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175854|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175855|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175856|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
191576|NCT01218438|O1|Outcome|Intravenous 10%|
175860|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175861|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175862|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175863|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175864|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175865|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175866|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175867|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175868|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175869|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175870|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175871|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175872|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175873|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175874|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175875|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175876|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175877|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175878|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175879|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175880|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175881|NCT01270464|E3|Reported Event|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175882|NCT01270464|E2|Reported Event|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
175883|NCT01270464|E1|Reported Event|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
175884|NCT01270256|B3|Baseline|Total|Total of all reporting groups
175885|NCT01270256|B2|Baseline|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
175886|NCT01270256|B1|Baseline|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
175887|NCT01270256|P2|Participant Flow|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
175888|NCT01270256|P1|Participant Flow|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
175889|NCT01270256|O2|Outcome|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
175890|NCT01270256|O1|Outcome|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
175891|NCT01270256|E2|Reported Event|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
175892|NCT01270256|E1|Reported Event|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
175893|NCT01270139|B4|Baseline|Total|Total of all reporting groups
175894|NCT01270139|B3|Baseline|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175895|NCT01270139|B2|Baseline|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175947|NCT01270126|E1|Reported Event|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
175948|NCT01269918|B3|Baseline|Total|Total of all reporting groups
191577|NCT01218438|O2|Outcome|Subcutaneous 20%|
175896|NCT01270139|B1|Baseline|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175897|NCT01270139|P3|Participant Flow|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175898|NCT01270139|P2|Participant Flow|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175899|NCT01270139|P1|Participant Flow|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175900|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175901|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175902|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175949|NCT01269918|B2|Baseline|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175950|NCT01269918|B1|Baseline|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
176028|NCT01268943|B2|Baseline|1200mg|capecitabine 600mg/m2 twice daily. 3 patients enrolled
176029|NCT01268943|B1|Baseline|1000mg|capecitabine 500mg/m2 twice daily. 6 patients enrolled
175903|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175904|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175905|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175906|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175907|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175908|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175909|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175924|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175910|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175911|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175912|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175913|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175914|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175915|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175916|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175941|NCT01270126|B1|Baseline|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
175942|NCT01270126|P2|Participant Flow|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
175917|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175918|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175919|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175920|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175921|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175922|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175923|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175943|NCT01270126|P1|Participant Flow|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
175944|NCT01270126|O2|Outcome|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
175925|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175926|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175927|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175928|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175929|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175930|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175931|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175945|NCT01270126|O1|Outcome|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
175946|NCT01270126|E2|Reported Event|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
175932|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175933|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175934|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175935|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175936|NCT01270139|E3|Reported Event|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
175937|NCT01270139|E2|Reported Event|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
175938|NCT01270139|E1|Reported Event|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
175939|NCT01270126|B3|Baseline|Total|Total of all reporting groups
175940|NCT01270126|B2|Baseline|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
175951|NCT01269918|P2|Participant Flow|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
191578|NCT01218438|O1|Outcome|Intravenous 10%|
175952|NCT01269918|P1|Participant Flow|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175953|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175954|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175955|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175956|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175957|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175958|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175959|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175960|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175961|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175962|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175963|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175964|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175965|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175966|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175967|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175968|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175969|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175970|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175971|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175972|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175973|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175974|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175975|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175976|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175977|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175978|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175979|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175980|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175981|NCT01269918|E2|Reported Event|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
175982|NCT01269918|E1|Reported Event|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
175983|NCT01269801|B3|Baseline|Total|Total of all reporting groups
175984|NCT01269801|B2|Baseline|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
175985|NCT01269801|B1|Baseline|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
175986|NCT01269801|P2|Participant Flow|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
175987|NCT01269801|P1|Participant Flow|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
175988|NCT01269801|O2|Outcome|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
175989|NCT01269801|O1|Outcome|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
175990|NCT01269801|E2|Reported Event|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
175991|NCT01269801|E1|Reported Event|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
175992|NCT01269710|B1|Baseline|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175993|NCT01269710|P1|Participant Flow|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175994|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
191579|NCT01218438|O2|Outcome|Subcutaneous 20%|
175995|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175996|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175997|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175998|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
175999|NCT01269710|E1|Reported Event|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
176000|NCT01269125|B4|Baseline|Total|Total of all reporting groups
176001|NCT01269125|B3|Baseline|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176002|NCT01269125|B2|Baseline|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176003|NCT01269125|B1|Baseline|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176004|NCT01269125|P3|Participant Flow|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176005|NCT01269125|P2|Participant Flow|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176006|NCT01269125|P1|Participant Flow|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176007|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176008|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176009|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176010|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176011|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176012|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176013|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176014|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176015|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176016|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176017|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176018|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176019|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176020|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176021|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176022|NCT01269125|E3|Reported Event|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
176023|NCT01269125|E2|Reported Event|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
176024|NCT01269125|E1|Reported Event|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
176025|NCT01268943|B5|Baseline|Total|Total of all reporting groups
176030|NCT01268943|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176031|NCT01268943|P3|Participant Flow|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176032|NCT01268943|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176033|NCT01268943|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176034|NCT01268943|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176035|NCT01268943|O3|Outcome|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176036|NCT01268943|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176037|NCT01268943|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176038|NCT01268943|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176039|NCT01268943|E3|Reported Event|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176040|NCT01268943|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176041|NCT01268943|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
176042|NCT01268891|B3|Baseline|Total|Total of all reporting groups
176043|NCT01268891|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 18 weeks
176044|NCT01268891|B1|Baseline|Placebo|Once daily; tablet; orally; 18 weeks
176045|NCT01268891|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 18 weeks
176046|NCT01268891|P1|Participant Flow|Placebo|Once daily; tablet; orally; 18 weeks
176047|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
176048|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
176049|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
176050|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
176051|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
176052|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
176053|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
176054|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
176055|NCT01268891|E2|Reported Event|Azilect®|
176056|NCT01268891|E1|Reported Event|Placebo|
176057|NCT01268683|B1|Baseline|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
176058|NCT01268683|P1|Participant Flow|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion; total of 3mg/day
176059|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
176060|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
176061|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
176062|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
176063|NCT01268683|E1|Reported Event|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
176064|NCT01268501|B1|Baseline|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
176065|NCT01268501|P1|Participant Flow|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
176066|NCT01268501|O1|Outcome|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
176067|NCT01268501|E1|Reported Event|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
176068|NCT01268488|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
176095|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176096|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176069|NCT01268488|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
176070|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
176071|NCT01268488|O1|Outcome|Intended Users of the System|Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
176072|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
176073|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
176074|NCT01268488|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
176075|NCT01268306|B1|Baseline|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
176076|NCT01268306|P1|Participant Flow|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
176077|NCT01268306|O1|Outcome|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
176078|NCT01268306|E1|Reported Event|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
176079|NCT01268293|B1|Baseline|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
176080|NCT01268293|P1|Participant Flow|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
176081|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
176082|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
176083|NCT01268293|E1|Reported Event|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
176084|NCT01268267|B1|Baseline|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
176085|NCT01268267|P1|Participant Flow|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
176086|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
176087|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
176088|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
176089|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
176090|NCT01268267|E1|Reported Event|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
176091|NCT01268189|B1|Baseline|Burn Wound Patients|Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
176092|NCT01268189|P1|Participant Flow|Burn Wound Patients|Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
176093|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176094|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176097|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176098|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176099|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176100|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176101|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176102|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176103|NCT01268189|E2|Reported Event|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
176104|NCT01268189|E1|Reported Event|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
176105|NCT01268150|B1|Baseline|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176106|NCT01268150|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176107|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176108|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176109|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176110|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176111|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176112|NCT01268150|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
176113|NCT01268111|B3|Baseline|Total|Total of all reporting groups
176114|NCT01268111|B2|Baseline|Placebo|Matching placebo q weekly for 8 weeks
176115|NCT01268111|B1|Baseline|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
176116|NCT01268111|P2|Participant Flow|Placebo|Matching placebo q weekly for 8 weeks
176117|NCT01268111|P1|Participant Flow|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
176118|NCT01268111|O2|Outcome|Placebo|Matching placebo q weekly for 8 weeks
176119|NCT01268111|O1|Outcome|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
176120|NCT01268111|E2|Reported Event|Placebo|Matching placebo q weekly for 8 weeks
176121|NCT01268111|E1|Reported Event|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
176122|NCT01268098|B3|Baseline|Total|Total of all reporting groups
176123|NCT01268098|B2|Baseline|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
176124|NCT01268098|B1|Baseline|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
176125|NCT01268098|P2|Participant Flow|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.
176126|NCT01268098|P1|Participant Flow|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
176127|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
176128|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
176129|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
176130|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
176131|NCT01268098|E2|Reported Event|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
176132|NCT01268098|E1|Reported Event|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
176133|NCT01267994|B1|Baseline|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
176134|NCT01267994|P1|Participant Flow|Open Label Trial|Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
176135|NCT01267994|O1|Outcome|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
176136|NCT01267994|E1|Reported Event|Single Arm|Anakinra administered for 84 consecutive days
176137|NCT01267929|B3|Baseline|Total|Total of all reporting groups
176138|NCT01267929|B2|Baseline|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
176162|NCT01267422|O1|Outcome|BCVA of Un-treated Eyes|BCVA of un-treated eyes in 9 patients
176163|NCT01267422|E2|Reported Event|Long-term Affects|Lens may be injured after intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Blood and urine routine is affected.Liver and kidney function is affected.Immune response after surgery.
176864|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176139|NCT01267929|B1|Baseline|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
176140|NCT01267929|P2|Participant Flow|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
176141|NCT01267929|P1|Participant Flow|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
176142|NCT01267929|O2|Outcome|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
176143|NCT01267929|O1|Outcome|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
176144|NCT01267929|E2|Reported Event|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
176145|NCT01267929|E1|Reported Event|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
176146|NCT01267422|B1|Baseline|All Study Participants|Age,Gender,Ethnicity,Race,Region of Enrollment
176147|NCT01267422|P2|Participant Flow|Participants Receiving Treatment in Right Eye|4 participants receiving treatment in right eye
176148|NCT01267422|P1|Participant Flow|Participants Receiving Treatment in Left Eye|5 participants receiving treatment in left eye
176149|NCT01267422|O2|Outcome|Mean VFI After Treatment|Mean VFI after treatment of injected eyes;Mean VFI after treatment of uninjected eyes
176150|NCT01267422|O1|Outcome|Mean VFI Before Treatment|Mean VFI before treatment of injected eyes;Mean VFI before treatment of uninjected eyes
176151|NCT01267422|O2|Outcome|Mean MD After Treatment|Mean MD after treatment of injected eyes;Mean MD after treatment of uninjected eyes
176152|NCT01267422|O1|Outcome|Mean MD Before Treatment|Mean MD before treatment of injected eyes;Mean MD before treatment of uninjected eyes
176153|NCT01267422|O2|Outcome|Average RNFL Thickness After Treatment|Average RNFL thickness after treatment of injected eyes;Average RNFL thickness after treatment of uninjected eyes
176154|NCT01267422|O1|Outcome|Average RNFL Thickness Before Treatment|Average RNFL thickness before treatment of injected eyes;Average RNFL thickness before treatment of uninjected eyes
176155|NCT01267422|O2|Outcome|The Mean of Neutralizing Antibody Assay After Treatment|The mean of Neutralizing antibody assay after treatment of 8 patients
176156|NCT01267422|O1|Outcome|The Mean of Neutralizing Antibody Assay Before Treatment|The mean of Neutralizing antibody assay before treatment of 8 patients
176157|NCT01267422|O2|Outcome|IOP After Treatment|Ophthalmologic examinations includes IOP of 9 participants after treatment
176158|NCT01267422|O1|Outcome|IOP Before Treatment|Ophthalmologic examinations includes IOP of 9 paticipants before treatment
176159|NCT01267422|O2|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ After Treatment|The mean percentage of CD3+ after treatment;The mean percentage of CD4+ after treatment;The mean percentage of CD8+ after treatment
176160|NCT01267422|O1|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ Before Treatment|The mean percentage of CD3+ before treatment;The mean percentage of CD4+ before treatment;The mean percentage of CD8+ before treatment
176161|NCT01267422|O2|Outcome|BCVA of Treated Eyes|BCVA of trearted eyes in 9 patients
176164|NCT01267422|E1|Reported Event|Short-term Affects|Lens may be injured during intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Endophthalmitis after treament. Hyper-susceptibility or immune response during surgery or after surgery.
176165|NCT01267266|B1|Baseline|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
176166|NCT01267266|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
176167|NCT01267266|P1|Participant Flow|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176168|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
176169|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176170|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
176171|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176172|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
176173|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176174|NCT01267266|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.~hydrocortisone/placebo: Given orally"
176175|NCT01267266|O1|Outcome|Arm I (Saracatinib)|"Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
176176|NCT01267266|E3|Reported Event|Placebo, Randomized Phase|Patients receive placebo once daily on days 1-28.
176177|NCT01267266|E2|Reported Event|Saracatinib, Randomized Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176178|NCT01267266|E1|Reported Event|Saracatinib, Lead-in Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
176179|NCT01267253|B1|Baseline|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176180|NCT01267253|P1|Participant Flow|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176181|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176182|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176183|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176184|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176185|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176186|NCT01267253|E1|Reported Event|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
176187|NCT01267227|B5|Baseline|Total|Total of all reporting groups
176188|NCT01267227|B4|Baseline|Placebo|Matching placebo twice daily
176189|NCT01267227|B3|Baseline|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
176190|NCT01267227|B2|Baseline|Low Dose|Pterostilbene 50 mg twice daily
176191|NCT01267227|B1|Baseline|High Dose|Pterostilbene 125 mg twice daily
176192|NCT01267227|P4|Participant Flow|Placebo|Matching placebo twice daily
176193|NCT01267227|P3|Participant Flow|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
176194|NCT01267227|P2|Participant Flow|Low Dose|Pterostilbene 50 mg twice daily
176195|NCT01267227|P1|Participant Flow|High Dose|Pterostilbene 125 mg twice daily
176196|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily
176197|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
176198|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily
176199|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily
176200|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
176201|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
176202|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
176203|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
176204|NCT01267227|E4|Reported Event|Placebo|Matching placebo twice daily
176205|NCT01267227|E3|Reported Event|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
176206|NCT01267227|E2|Reported Event|Low Dose|Pterostilbene 50 mg twice daily
176207|NCT01267227|E1|Reported Event|High Dose|Pterostilbene 125 mg twice daily
176208|NCT01267201|B1|Baseline|Entire Study Population|Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first.
176209|NCT01267201|P6|Participant Flow|Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176210|NCT01267201|P5|Participant Flow|Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176211|NCT01267201|P4|Participant Flow|Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176212|NCT01267201|P3|Participant Flow|Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176213|NCT01267201|P2|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1|Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176214|NCT01267201|P1|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2|Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
176215|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
176216|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
176217|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
176218|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
176219|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
176220|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
176221|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
176222|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
176223|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
176224|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
176225|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
176226|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
176227|NCT01267201|E3|Reported Event|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
176228|NCT01267201|E2|Reported Event|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
176229|NCT01267201|E1|Reported Event|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
176230|NCT01267175|B1|Baseline|X54 Pump|All subjects transferred from current pump to X54
176231|NCT01267175|P1|Participant Flow|X54 Pump|All subjects transferred from current pump to X54
176232|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
176233|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
176234|NCT01267175|E1|Reported Event|X54 Pump|All subjects transferred from current pump to X54
176235|NCT01267136|B3|Baseline|Total|Total of all reporting groups
176236|NCT01267136|B2|Baseline|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
176237|NCT01267136|B1|Baseline|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
176238|NCT01267136|P2|Participant Flow|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
176239|NCT01267136|P1|Participant Flow|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
176240|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
176241|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
176242|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
176243|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
176244|NCT01267136|E2|Reported Event|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
176245|NCT01267136|E1|Reported Event|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
176246|NCT01267045|B3|Baseline|Total|Total of all reporting groups
176247|NCT01267045|B2|Baseline|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176248|NCT01267045|B1|Baseline|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176249|NCT01267045|P2|Participant Flow|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176250|NCT01267045|P1|Participant Flow|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176251|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176252|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176253|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176254|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176255|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176256|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176257|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176258|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176259|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176260|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176261|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176262|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176263|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176264|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176265|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176266|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176267|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176268|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176269|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176285|NCT01266967|P1|Participant Flow|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176286|NCT01266967|O2|Outcome|ThxID BRAF Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
191580|NCT01218438|O1|Outcome|Intravenous 10%|
176270|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176271|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176272|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176273|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176274|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176275|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176276|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
176277|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176278|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
176279|NCT01267045|E2|Reported Event|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
176280|NCT01267045|E1|Reported Event|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course.~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
176281|NCT01266967|B3|Baseline|Total|Total of all reporting groups
176282|NCT01266967|B2|Baseline|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176283|NCT01266967|B1|Baseline|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176284|NCT01266967|P2|Participant Flow|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176287|NCT01266967|O1|Outcome|RGI IUO Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
176288|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176289|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176290|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176291|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176292|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176293|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176294|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176295|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176296|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176297|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176298|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176299|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176300|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176301|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176302|NCT01266967|O1|Outcome|GSK2118436 150 mg|Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
176303|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176304|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176305|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176306|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176307|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176308|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176309|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176670|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176310|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176311|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176312|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176313|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176314|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176315|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176316|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176317|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176318|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176319|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176320|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176321|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176322|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176323|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176324|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176325|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176326|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176327|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176328|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176329|NCT01266967|E2|Reported Event|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176330|NCT01266967|E1|Reported Event|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
176331|NCT01266876|B6|Baseline|Total|Total of all reporting groups
176332|NCT01266876|B5|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176333|NCT01266876|B4|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176334|NCT01266876|B3|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176335|NCT01266876|B2|Baseline|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176336|NCT01266876|B1|Baseline|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176337|NCT01266876|P5|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176338|NCT01266876|P4|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176339|NCT01266876|P3|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176340|NCT01266876|P2|Participant Flow|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176341|NCT01266876|P1|Participant Flow|Placebo|Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176342|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176343|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176344|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176345|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176346|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176347|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176348|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176349|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176350|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176351|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176352|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176353|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176354|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176355|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176356|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176357|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176358|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176359|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176360|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176361|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176362|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176363|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176364|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176365|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176366|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176367|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176368|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176369|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176370|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176371|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176372|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176373|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176374|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176375|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176376|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176377|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176378|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176379|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176380|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176381|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176382|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176383|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176384|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176385|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176386|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176387|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176388|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176389|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176390|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176391|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176392|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176393|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176394|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176395|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176396|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176397|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176398|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176399|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176400|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176401|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176402|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176403|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176404|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176405|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176406|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176407|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176408|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176409|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176410|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176411|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176412|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176413|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176414|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176415|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176416|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176417|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176418|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176419|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
191581|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
176420|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176421|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176422|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176423|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176424|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176425|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176426|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176427|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176428|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176429|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176430|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176431|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176432|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176433|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176434|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176435|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176436|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176437|NCT01266876|E5|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176438|NCT01266876|E4|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176439|NCT01266876|E3|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176440|NCT01266876|E2|Reported Event|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176441|NCT01266876|E1|Reported Event|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
176442|NCT01266850|B6|Baseline|Total|Total of all reporting groups
176443|NCT01266850|B5|Baseline|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.
176444|NCT01266850|B4|Baseline|Group 4: Rotarix, Rotarix|Participants received 2-mL Rotarix® orally at 2 and 4 months of age.
176445|NCT01266850|B3|Baseline|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.
176446|NCT01266850|B2|Baseline|Group 2: RotaTeq, Rotarix, Rotarix|Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.
176447|NCT01266850|B1|Baseline|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.
176448|NCT01266850|P5|Participant Flow|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176449|NCT01266850|P4|Participant Flow|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176450|NCT01266850|P3|Participant Flow|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176451|NCT01266850|P2|Participant Flow|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176452|NCT01266850|P1|Participant Flow|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176453|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176454|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176455|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176456|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176457|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176458|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176459|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176460|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176461|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176462|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176463|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176464|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176465|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176466|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176467|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176468|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176469|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176470|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176471|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176472|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176473|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176474|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176475|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176476|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176477|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176478|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176479|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176480|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176481|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176482|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176483|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176484|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176485|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176486|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176487|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176488|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176489|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176490|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176491|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176492|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176493|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176494|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176495|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176496|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176497|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176498|NCT01266850|E5|Reported Event|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
176499|NCT01266850|E4|Reported Event|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
176500|NCT01266850|E3|Reported Event|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
176501|NCT01266850|E2|Reported Event|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
176502|NCT01266850|E1|Reported Event|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
176503|NCT01266824|B3|Baseline|Total|Total of all reporting groups
176504|NCT01266824|B2|Baseline|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176505|NCT01266824|B1|Baseline|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
191582|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
176506|NCT01266824|P2|Participant Flow|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176507|NCT01266824|P1|Participant Flow|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176508|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176509|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176510|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176511|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176512|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176513|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176514|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176515|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176516|NCT01266824|E2|Reported Event|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
176517|NCT01266824|E1|Reported Event|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
176518|NCT01266447|B1|Baseline|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176519|NCT01266447|P1|Participant Flow|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176520|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176521|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176522|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176523|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176524|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176525|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176526|NCT01266447|E1|Reported Event|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
176527|NCT01266265|B3|Baseline|Total|Total of all reporting groups
176528|NCT01266265|B2|Baseline|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
176529|NCT01266265|B1|Baseline|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
191583|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
176530|NCT01266265|P2|Participant Flow|Control|"The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician"
176531|NCT01266265|P1|Participant Flow|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
176532|NCT01266265|O2|Outcome|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
176533|NCT01266265|O1|Outcome|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
176534|NCT01266265|E2|Reported Event|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
176535|NCT01266265|E1|Reported Event|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
176536|NCT01266148|B3|Baseline|Total|Total of all reporting groups
176537|NCT01266148|B2|Baseline|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176538|NCT01266148|B1|Baseline|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176539|NCT01266148|P2|Participant Flow|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176540|NCT01266148|P1|Participant Flow|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176541|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176542|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176543|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176544|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176545|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176546|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176547|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176548|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176549|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176550|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176551|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176552|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176553|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176554|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176555|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176556|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176557|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176558|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176559|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176560|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176561|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
176562|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176563|NCT01266148|E2|Reported Event|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
176564|NCT01266148|E1|Reported Event|Controls|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study
176565|NCT01266122|B3|Baseline|Total|Total of all reporting groups
176671|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176566|NCT01266122|B2|Baseline|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
176567|NCT01266122|B1|Baseline|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
176568|NCT01266122|P2|Participant Flow|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
176569|NCT01266122|P1|Participant Flow|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
176570|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
176571|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
176572|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
176573|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
176574|NCT01266122|E2|Reported Event|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
176575|NCT01266122|E1|Reported Event|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
176576|NCT01266070|B1|Baseline|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
176577|NCT01266070|P1|Participant Flow|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
176578|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
176579|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
176580|NCT01266070|E1|Reported Event|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
176581|NCT01266031|B4|Baseline|Total|Total of all reporting groups
176582|NCT01266031|B3|Baseline|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
176583|NCT01266031|B2|Baseline|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
176584|NCT01266031|B1|Baseline|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
176585|NCT01266031|P3|Participant Flow|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
176586|NCT01266031|P2|Participant Flow|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
176587|NCT01266031|P1|Participant Flow|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
176588|NCT01266031|O1|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
176589|NCT01266031|O2|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
176590|NCT01266031|O1|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
176591|NCT01266031|E3|Reported Event|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
176592|NCT01266031|E2|Reported Event|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
176593|NCT01266031|E1|Reported Event|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
176594|NCT01265992|B1|Baseline|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176595|NCT01265992|P1|Participant Flow|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176596|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176597|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176598|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176599|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176600|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176601|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176602|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176603|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176604|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176605|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176606|NCT01265992|E1|Reported Event|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
176607|NCT01265966|B4|Baseline|Total|Total of all reporting groups
176608|NCT01265966|B3|Baseline|General Anesthesia|Children undergoing general anesthesia for procedures.
176609|NCT01265966|B2|Baseline|Deep Sedation|Children undergoing deep sedation for procedures.
176610|NCT01265966|B1|Baseline|Moderate Sedation|Children undergoing moderate sedation for procedures.
176611|NCT01265966|P3|Participant Flow|General Anesthesia|Children undergoing general anesthesia for procedures.
176612|NCT01265966|P2|Participant Flow|Deep Sedation|Children undergoing deep sedation for procedures.
176613|NCT01265966|P1|Participant Flow|Moderate Sedation|Children undergoing moderate sedation for procedures.
176614|NCT01265966|O3|Outcome|General Anesthesia|Children undergoing general anesthesia for procedures.
176615|NCT01265966|O2|Outcome|Deep Sedation|Children undergoing deep sedation for procedures.
176616|NCT01265966|O1|Outcome|Moderate Sedation|Children undergoing moderate sedation for procedures.
176617|NCT01265966|E3|Reported Event|General Anesthesia|Children undergoing general anesthesia for procedures.
176618|NCT01265966|E2|Reported Event|Deep Sedation|Children undergoing deep sedation for procedures.
176619|NCT01265966|E1|Reported Event|Moderate Sedation|Children undergoing moderate sedation for procedures.
176620|NCT01265875|B1|Baseline|Human Secretin|Human Secretin : Dose Escalation
176621|NCT01265875|P1|Participant Flow|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
176622|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
176623|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
176624|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
176625|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
176626|NCT01265875|O1|Outcome|Human Secretin|Human Secretin : Dose Escalation
176627|NCT01265875|E1|Reported Event|Human Secretin|Human Secretin : Dose Escalation within participant
176628|NCT01265823|B1|Baseline|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176629|NCT01265823|P1|Participant Flow|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176630|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176631|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176632|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176633|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176634|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176672|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176635|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176636|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176637|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176638|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176639|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176640|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176641|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176642|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176643|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176644|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176645|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176646|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176647|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176648|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176649|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176650|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176651|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176652|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176653|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176654|NCT01265823|E1|Reported Event|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
176655|NCT01265797|B3|Baseline|Total|Total of all reporting groups
176656|NCT01265797|B2|Baseline|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176657|NCT01265797|B1|Baseline|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176658|NCT01265797|P2|Participant Flow|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176659|NCT01265797|P1|Participant Flow|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176660|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176661|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176662|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176663|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176664|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176665|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176666|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176667|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176668|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176669|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176865|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176673|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176674|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176675|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176676|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176677|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176678|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176679|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176680|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
176681|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
176682|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
176683|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
176684|NCT01265797|E2|Reported Event|Sham|Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days
176685|NCT01265797|E1|Reported Event|Verum|Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days
176686|NCT01265784|B4|Baseline|Total|Total of all reporting groups
176687|NCT01265784|B3|Baseline|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176688|NCT01265784|B2|Baseline|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176689|NCT01265784|B1|Baseline|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176690|NCT01265784|P3|Participant Flow|Ertapenem, 1 g q24h|Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176691|NCT01265784|P2|Participant Flow|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176692|NCT01265784|P1|Participant Flow|TP-434, 1.5 mg/kg q24h|TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176693|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176694|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176695|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176696|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176697|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176698|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176699|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176700|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176701|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176702|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176703|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176704|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176705|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176706|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176707|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176708|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176709|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176710|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176711|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176712|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176798|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176713|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176714|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176715|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176716|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176717|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176718|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176719|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176720|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176721|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176722|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176723|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176724|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176725|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176726|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176727|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176728|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176729|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176730|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176731|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176732|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176733|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176734|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176735|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176736|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176737|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176738|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176739|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176740|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176741|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176742|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176743|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176744|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176745|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176746|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176747|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176748|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176749|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176750|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176751|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176752|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176753|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176754|NCT01265784|E3|Reported Event|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176755|NCT01265784|E2|Reported Event|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176756|NCT01265784|E1|Reported Event|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
176757|NCT01265615|B5|Baseline|Total|Total of all reporting groups
176758|NCT01265615|B4|Baseline|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176759|NCT01265615|B3|Baseline|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176760|NCT01265615|B2|Baseline|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176761|NCT01265615|B1|Baseline|Paricalcitol Treatment|6-8 μg daily per os without special diet
176762|NCT01265615|P4|Participant Flow|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176763|NCT01265615|P3|Participant Flow|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176764|NCT01265615|P2|Participant Flow|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176765|NCT01265615|P1|Participant Flow|Paricalcitol Treatment|6-8 μg daily per os without special diet
176766|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176767|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176768|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176769|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176770|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176771|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176772|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176773|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176774|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176775|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176776|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176777|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176778|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176779|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176780|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176781|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176782|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176783|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176784|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176785|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176786|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176787|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176788|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176789|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176790|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176791|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176792|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176793|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176794|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176795|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176796|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176797|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176863|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176799|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176800|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176801|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176802|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176803|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176804|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176805|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
176806|NCT01265615|E4|Reported Event|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
176807|NCT01265615|E3|Reported Event|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
176808|NCT01265615|E2|Reported Event|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
176809|NCT01265615|E1|Reported Event|Paricalcitol Treatment|6-8 μg daily per os without special diet
176810|NCT01265524|B3|Baseline|Total|Total of all reporting groups
176811|NCT01265524|B2|Baseline|Placebo|Placebo: capsules
176812|NCT01265524|B1|Baseline|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176813|NCT01265524|P2|Participant Flow|Placebo|Placebo: capsules
176814|NCT01265524|P1|Participant Flow|Investigational Drug: CLP|Investigational drug: 15 g CLP per day given as capsules
176815|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176816|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176817|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176818|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176819|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176820|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176821|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176822|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176823|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176824|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176825|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176826|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176827|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
176828|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176829|NCT01265524|E2|Reported Event|Placebo|Placebo: capsules
176830|NCT01265524|E1|Reported Event|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
176831|NCT01265498|B3|Baseline|Total|Total of all reporting groups
176832|NCT01265498|B2|Baseline|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176833|NCT01265498|B1|Baseline|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176834|NCT01265498|P2|Participant Flow|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176835|NCT01265498|P1|Participant Flow|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176836|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176837|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176838|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176839|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176840|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176841|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176842|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176843|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176844|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176845|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176846|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176847|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176848|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176849|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176850|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176851|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176852|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176853|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176854|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176855|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176856|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176857|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176858|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176859|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176860|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176861|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176862|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176866|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176867|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176868|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176869|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176870|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176871|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176872|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176873|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176874|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176875|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176876|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176877|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176878|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176879|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176880|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176881|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176882|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176883|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176884|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176885|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176886|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176887|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176888|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176889|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176890|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176891|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176892|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176893|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176894|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176895|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176896|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176897|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176898|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176899|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176900|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176901|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176902|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176903|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176904|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176905|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176906|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176907|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176908|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176909|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176910|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176911|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176912|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176913|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176914|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176915|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176916|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176917|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176918|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176919|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176920|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176921|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176922|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176923|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176924|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176925|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176926|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176927|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176928|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
191584|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
176929|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176930|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176931|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176932|NCT01265498|E2|Reported Event|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
176933|NCT01265498|E1|Reported Event|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
176934|NCT01265459|B4|Baseline|Total|Total of all reporting groups
176935|NCT01265459|B3|Baseline|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176936|NCT01265459|B2|Baseline|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176937|NCT01265459|B1|Baseline|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176938|NCT01265459|P3|Participant Flow|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176939|NCT01265459|P2|Participant Flow|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176940|NCT01265459|P1|Participant Flow|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176941|NCT01265459|O3|Outcome|Durolane 6 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
176942|NCT01265459|O2|Outcome|Durolane 4.5 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
176943|NCT01265459|O1|Outcome|Durolane 3 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
176944|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176945|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176946|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176947|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176948|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176949|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
176950|NCT01265459|O3|Outcome|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176951|NCT01265459|O2|Outcome|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176952|NCT01265459|O1|Outcome|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176953|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
176954|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
176955|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
176956|NCT01265459|E3|Reported Event|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176957|NCT01265459|E2|Reported Event|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176958|NCT01265459|E1|Reported Event|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
176959|NCT01265446|B3|Baseline|Total|Total of all reporting groups
176960|NCT01265446|B2|Baseline|Lidocaine 1mg + CPC 2mg|one single dose
176961|NCT01265446|B1|Baseline|Lidocaine 8mg +CPC 2mg|one single dose
176962|NCT01265446|P2|Participant Flow|Lidocaine 1mg + CPC 2mg|one single dose
176963|NCT01265446|P1|Participant Flow|Lidocaine 8mg +CPC 2mg|one single dose
176964|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
176965|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
176966|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
176967|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
176968|NCT01265446|E2|Reported Event|Lidocaine 1mg + CPC 2mg|one single dose
176969|NCT01265446|E1|Reported Event|Lidocaine 8mg +CPC 2mg|one single dose
176970|NCT01265420|B1|Baseline|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
176971|NCT01265420|P1|Participant Flow|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
176972|NCT01265420|O1|Outcome|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
176973|NCT01265420|E1|Reported Event|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
176974|NCT01265394|B1|Baseline|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
176975|NCT01265394|P1|Participant Flow|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
176976|NCT01265394|O1|Outcome|(18F) Flutemetamol Injection|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
176977|NCT01265394|O1|Outcome|Normal and Abnormal Reads With or Without Amyloid|Each Subject received a dose of [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
176978|NCT01265394|E1|Reported Event|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
176979|NCT01265056|B3|Baseline|Total|Total of all reporting groups
176980|NCT01265056|B2|Baseline|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
176981|NCT01265056|B1|Baseline|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
176982|NCT01265056|P2|Participant Flow|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
176983|NCT01265056|P1|Participant Flow|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
176984|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
176985|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
176986|NCT01265056|E2|Reported Event|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
176987|NCT01265056|E1|Reported Event|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
176988|NCT01264952|B4|Baseline|Total|Total of all reporting groups
176989|NCT01264952|B3|Baseline|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
176990|NCT01264952|B2|Baseline|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
176991|NCT01264952|B1|Baseline|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
176992|NCT01264952|P3|Participant Flow|Group III|The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
176993|NCT01264952|P2|Participant Flow|Group II|The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
176994|NCT01264952|P1|Participant Flow|Group I|The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
176995|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
176996|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
176997|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
176998|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
176999|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
177000|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
177001|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
177037|NCT01264887|P1|Participant Flow|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177002|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
177003|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
177004|NCT01264952|E3|Reported Event|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
177005|NCT01264952|E2|Reported Event|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
177006|NCT01264952|E1|Reported Event|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
177007|NCT01264939|B3|Baseline|Total|Total of all reporting groups
177008|NCT01264939|B2|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177009|NCT01264939|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177010|NCT01264939|P2|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177011|NCT01264939|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177012|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177013|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177014|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177015|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177016|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177017|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177018|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177019|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177020|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177021|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177022|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177023|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177024|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177025|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177026|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177027|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177028|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177029|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177030|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177031|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177032|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177033|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177034|NCT01264939|E2|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
177035|NCT01264939|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
177036|NCT01264887|B1|Baseline|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177038|NCT01264887|O1|Outcome|Frequency of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177039|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177040|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177041|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177042|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177043|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177044|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177045|NCT01264887|O1|Outcome|Number of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177046|NCT01264887|E1|Reported Event|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
177047|NCT01264835|B1|Baseline|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
177048|NCT01264835|P1|Participant Flow|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
177049|NCT01264835|O1|Outcome|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
177050|NCT01264835|E1|Reported Event|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
177051|NCT01264770|B7|Baseline|Total|Total of all reporting groups
177052|NCT01264770|B6|Baseline|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
177053|NCT01264770|B5|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
177054|NCT01264770|B4|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
177055|NCT01264770|B3|Baseline|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
177056|NCT01264770|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
177057|NCT01264770|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
177058|NCT01264770|P6|Participant Flow|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
177059|NCT01264770|P5|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
177060|NCT01264770|P4|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
177061|NCT01264770|P3|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
177062|NCT01264770|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
177063|NCT01264770|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
177064|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177065|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177066|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177067|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177068|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177069|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177070|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177071|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177072|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177073|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177074|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177075|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177076|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177077|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177078|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177079|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177080|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177081|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177084|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177085|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177086|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177087|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177088|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177089|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177090|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177091|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
177092|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177093|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177094|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177095|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177096|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177097|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177098|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
177099|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177100|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177101|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177102|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177103|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177104|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177105|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
177106|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177107|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177108|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177109|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177110|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177111|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177112|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
177113|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177114|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177115|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177116|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177117|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177118|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177119|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177120|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177121|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177122|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177123|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
177124|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177125|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177126|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177127|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177128|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
177129|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
177130|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
177131|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177132|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177133|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177134|NCT01264770|O4|Outcome|Dosing Group E|PLACEBO (COMBINED)
177135|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
177136|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
177137|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
177138|NCT01264770|E8|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
177139|NCT01264770|E7|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
177140|NCT01264770|E6|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period|
177141|NCT01264770|E5|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod|
177142|NCT01264770|E4|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|
177143|NCT01264770|E3|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD|Dosing Group C
177144|NCT01264770|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
177145|NCT01264770|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
177146|NCT01264614|B3|Baseline|Total|Total of all reporting groups
177147|NCT01264614|B2|Baseline|Normative Older Adults|Normative older adults with no known history of neurological condition.
177148|NCT01264614|B1|Baseline|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177149|NCT01264614|P2|Participant Flow|Normative Older Adults|Normative older adults with no known history of neurological condition.
177150|NCT01264614|P1|Participant Flow|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177151|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
177152|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177153|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
177154|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177155|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
177156|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177157|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
177158|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177159|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
177160|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177161|NCT01264614|E2|Reported Event|Normative Older Adults|Normative older adults with no known history of neurological condition.
177162|NCT01264614|E1|Reported Event|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
177163|NCT01264380|B1|Baseline|All Participants|Included all participants who received single oral dose of vemurafenib tablet at 960 mg in fasted condition first and fed condition first in Period A and Period B and twice daily dose of vemurafenib tablet at 960 mg in Period C.
177164|NCT01264380|P3|Participant Flow|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
177165|NCT01264380|P2|Participant Flow|Vemurafenib (RO5185426): Fed Then Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fasted condition Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
177166|NCT01264380|P1|Participant Flow|Vemurafenib (RO5185426): Fasted Then Fed|Single oral dose of vemurafenib tablet at 960 milligrams (mg) on Day 1 was administered to participants in fasted condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fed condition (Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
177167|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
177168|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
177169|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177170|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177171|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177172|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177173|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177174|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177175|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177176|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177177|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177178|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177179|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177180|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177181|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177182|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177183|NCT01264380|E3|Reported Event|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
177184|NCT01264380|E2|Reported Event|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
177185|NCT01264380|E1|Reported Event|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
177186|NCT01264081|B1|Baseline|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
177187|NCT01264081|P1|Participant Flow|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
177903|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177188|NCT01264081|O1|Outcome|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
177189|NCT01264081|O1|Outcome|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
177190|NCT01264081|E1|Reported Event|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
177191|NCT01264016|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
177192|NCT01264016|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
177193|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
177194|NCT01264016|O1|Outcome|Study Staff Test Subject Venous Blood|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood.
177195|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
177196|NCT01264016|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
177197|NCT01263925|B3|Baseline|Total|Total of all reporting groups
177198|NCT01263925|B2|Baseline|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177199|NCT01263925|B1|Baseline|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177200|NCT01263925|P2|Participant Flow|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177201|NCT01263925|P1|Participant Flow|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177202|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177203|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177204|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177205|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177206|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177207|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177208|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
191585|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
177209|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177210|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177211|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177212|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177213|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177214|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177215|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177216|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177217|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177218|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177219|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177220|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177221|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177222|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177246|NCT01263717|B2|Baseline|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
191586|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
177223|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177224|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177225|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177226|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177227|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177228|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177229|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177230|NCT01263925|E2|Reported Event|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
177231|NCT01263925|E1|Reported Event|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
177232|NCT01263873|B3|Baseline|Total|Total of all reporting groups
177233|NCT01263873|B2|Baseline|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177234|NCT01263873|B1|Baseline|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177235|NCT01263873|P2|Participant Flow|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177236|NCT01263873|P1|Participant Flow|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177237|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177238|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177239|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177240|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177241|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177242|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177243|NCT01263873|E2|Reported Event|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
177244|NCT01263873|E1|Reported Event|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
177245|NCT01263717|B3|Baseline|Total|Total of all reporting groups
191587|NCT01218438|O1|Outcome|Correction Factor|
177247|NCT01263717|B1|Baseline|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177248|NCT01263717|P2|Participant Flow|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177249|NCT01263717|P1|Participant Flow|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177250|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177251|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177252|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177253|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177254|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177255|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177256|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177257|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177258|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177259|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177260|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177261|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177262|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177263|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177264|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177265|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177266|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177267|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177268|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177269|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177270|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177271|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177272|NCT01263717|E2|Reported Event|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
177273|NCT01263717|E1|Reported Event|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
177274|NCT01263691|B7|Baseline|Total|Total of all reporting groups
177275|NCT01263691|B6|Baseline|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177276|NCT01263691|B5|Baseline|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177277|NCT01263691|B4|Baseline|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177438|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177278|NCT01263691|B3|Baseline|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177279|NCT01263691|B2|Baseline|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177280|NCT01263691|B1|Baseline|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177281|NCT01263691|P6|Participant Flow|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177282|NCT01263691|P5|Participant Flow|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177283|NCT01263691|P4|Participant Flow|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177284|NCT01263691|P3|Participant Flow|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177285|NCT01263691|P2|Participant Flow|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177286|NCT01263691|P1|Participant Flow|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177287|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177288|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177289|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177290|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177291|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177292|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177293|NCT01263691|O18|Outcome|Female Saline|Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177294|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177295|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177296|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177297|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177298|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177584|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177299|NCT01263691|O12|Outcome|Male Saline|Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177300|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177301|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177302|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177303|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177304|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177305|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177306|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177307|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177308|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177309|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177310|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177311|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177312|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177313|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177314|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177315|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177316|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177317|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177318|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177319|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177320|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177585|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177321|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177322|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177323|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177324|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177325|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177326|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177327|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177328|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177329|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177330|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177331|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177332|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177333|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177334|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177335|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177336|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177337|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177338|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177339|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177340|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177341|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177342|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177343|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177344|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177345|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177346|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177347|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177348|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177349|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177350|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177351|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177352|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177353|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177354|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177355|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177356|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177357|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177358|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177359|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177360|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177361|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177362|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177363|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177364|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177365|NCT01263691|O18|Outcome|Female Saline|Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177366|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177367|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177368|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177369|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177370|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177371|NCT01263691|O12|Outcome|Male Saline|Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177372|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177373|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177374|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177375|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177376|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177377|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
178471|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
177378|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177379|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177380|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177381|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177382|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
177383|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177384|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177385|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177386|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177387|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177388|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177389|NCT01263691|E6|Reported Event|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
177390|NCT01263691|E5|Reported Event|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177391|NCT01263691|E4|Reported Event|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177392|NCT01263691|E3|Reported Event|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177393|NCT01263691|E2|Reported Event|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
177394|NCT01263691|E1|Reported Event|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
177395|NCT01263665|B1|Baseline|Investigational Arm|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
177396|NCT01263665|P1|Participant Flow|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|"25 cm length GORE® VIABAHN® Endoprosthesis with~> PROPATEN Bioactive Surface Subjects"
177397|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
177398|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
177399|NCT01263665|E1|Reported Event|25 cm GORE VIABAHN|25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
177400|NCT01263639|B3|Baseline|Total|Total of all reporting groups
177401|NCT01263639|B2|Baseline|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
177402|NCT01263639|B1|Baseline|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
177403|NCT01263639|P2|Participant Flow|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
177404|NCT01263639|P1|Participant Flow|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
177586|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177405|NCT01263639|O2|Outcome|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
177406|NCT01263639|O1|Outcome|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
177407|NCT01263639|E2|Reported Event|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
177408|NCT01263639|E1|Reported Event|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
177409|NCT01263561|B3|Baseline|Total|Total of all reporting groups
177410|NCT01263561|B2|Baseline|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177411|NCT01263561|B1|Baseline|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177412|NCT01263561|P2|Participant Flow|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177413|NCT01263561|P1|Participant Flow|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177414|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177415|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177416|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177417|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177418|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177419|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177420|NCT01263561|E2|Reported Event|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
177421|NCT01263561|E1|Reported Event|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
177422|NCT01263509|B3|Baseline|Total|Total of all reporting groups
177423|NCT01263509|B2|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177424|NCT01263509|B1|Baseline|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177425|NCT01263509|P4|Participant Flow|α-glucosidase Monotherapy Group*→ 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
177426|NCT01263509|P3|Participant Flow|α-glucosidase Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
177427|NCT01263509|P2|Participant Flow|25 mg Combination Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
177428|NCT01263509|P1|Participant Flow|12.5 mg Combination Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
177429|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177430|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177431|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177432|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177433|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177434|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177435|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177436|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177437|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
178472|NCT01262352|E2|Reported Event|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
177439|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177440|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177441|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177442|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177443|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177444|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177445|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177446|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177447|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177448|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177449|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177450|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177451|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177452|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177453|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177454|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177455|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177456|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177457|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177458|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177459|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177460|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177461|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177462|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177463|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177464|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177465|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177466|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177467|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177468|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177469|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177470|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177471|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177472|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177473|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177587|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177474|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177475|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177476|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177477|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177478|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177479|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177480|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177481|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177482|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177483|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177484|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177485|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177486|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177487|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177488|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177489|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177490|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177491|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177492|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177493|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177494|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177495|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177496|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177497|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177498|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177499|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177500|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177501|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177502|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177503|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177504|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177505|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177506|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177507|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177508|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177588|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177509|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177510|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177511|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177512|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177513|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177514|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177515|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177516|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177517|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177518|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177519|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177520|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177521|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177522|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177523|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177524|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177525|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177526|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177527|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177528|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177529|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177530|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177531|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177532|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177533|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177534|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177535|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177536|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177537|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177538|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177539|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177540|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177541|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177542|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177543|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177589|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177544|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177545|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177546|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177547|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177548|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177549|NCT01263509|E2|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177550|NCT01263509|E1|Reported Event|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177551|NCT01263496|B6|Baseline|Total|Total of all reporting groups
177552|NCT01263496|B5|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177553|NCT01263496|B4|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177554|NCT01263496|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177555|NCT01263496|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177556|NCT01263496|B1|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177557|NCT01263496|P9|Participant Flow|Placebo Dose Group* → Alogliptin 50 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177558|NCT01263496|P8|Participant Flow|Placebo Dose Group* → Alogliptin 25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177559|NCT01263496|P7|Participant Flow|Placebo Dose Group* → Alogliptin 12.5 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177560|NCT01263496|P6|Participant Flow|Placebo Dose Group* → Alogliptin 6.25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177561|NCT01263496|P5|Participant Flow|Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group|"Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177562|NCT01263496|P4|Participant Flow|Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group|"Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177563|NCT01263496|P3|Participant Flow|Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177564|NCT01263496|P2|Participant Flow|Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177565|NCT01263496|P1|Participant Flow|Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group|"Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
177566|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177567|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177568|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177569|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177570|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177571|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177572|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177573|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177574|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177575|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177576|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177577|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177578|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177579|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177580|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177581|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177582|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177583|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177590|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177591|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177592|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177593|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177594|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177595|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177596|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177597|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177598|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177599|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177600|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177601|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177602|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177603|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177604|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177605|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177606|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177607|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177608|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177609|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177610|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177611|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177612|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177613|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177614|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177615|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177616|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177617|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177618|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177619|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177620|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177621|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177622|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177623|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177624|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177625|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177626|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177627|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177628|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177629|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177630|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177631|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177632|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177633|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177634|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177635|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177636|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177637|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177638|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177639|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177640|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177641|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177642|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177643|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177644|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177645|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177646|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177647|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177648|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177649|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177650|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177651|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177652|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177653|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177654|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177655|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177656|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177657|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177658|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177659|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177660|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177661|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177662|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177663|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177664|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177665|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177666|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177667|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177668|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177669|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177670|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177671|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177672|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177673|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177674|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177675|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177676|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177677|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177678|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177679|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177680|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177681|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177682|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177683|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177684|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177685|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177686|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177687|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177688|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177689|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177690|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177691|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177692|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177693|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177694|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177695|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177696|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177697|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177698|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177699|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177700|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177701|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177702|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177703|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177704|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177705|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177706|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177707|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177708|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177709|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177710|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177711|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177712|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177713|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177714|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177715|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177716|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177717|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177718|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177719|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177720|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177721|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177722|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177723|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177724|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177725|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177726|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177727|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177728|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177729|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177730|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177731|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177732|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177733|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177734|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177735|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177736|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177737|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177738|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177739|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177740|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177741|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177742|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177743|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177744|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177745|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177746|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177747|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177748|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177749|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177750|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177751|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177752|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177753|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177754|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177755|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177756|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177757|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177758|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177759|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177760|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177761|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177762|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177763|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177764|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177765|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177766|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177767|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177768|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177769|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177770|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177771|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177772|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177773|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177774|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177775|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177776|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177777|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177778|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177779|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177780|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177781|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177782|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177783|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177784|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177785|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177786|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177787|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177788|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177789|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177790|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177791|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177792|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177793|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177794|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177795|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177796|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177797|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177798|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177799|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177800|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177801|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177802|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177803|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177804|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177805|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177806|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177807|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177808|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177809|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177810|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177811|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177812|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177813|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177814|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177815|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177816|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177817|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177818|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177819|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177820|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177821|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177822|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177823|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177824|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177825|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177826|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177827|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177828|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177829|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177830|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177831|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177832|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177833|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177834|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177835|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177836|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177837|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177838|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177839|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177840|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177841|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177842|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177843|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177844|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177845|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177846|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177847|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177848|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177849|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177850|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177851|NCT01263496|E5|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
177852|NCT01263496|E4|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
177853|NCT01263496|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
177854|NCT01263496|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
177855|NCT01263496|E1|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
177856|NCT01263483|B4|Baseline|Total|Total of all reporting groups
177857|NCT01263483|B3|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177858|NCT01263483|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177859|NCT01263483|B1|Baseline|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177860|NCT01263483|P3|Participant Flow|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177861|NCT01263483|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177862|NCT01263483|P1|Participant Flow|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177863|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177864|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177865|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177866|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177867|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177868|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177869|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177870|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177871|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177872|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177873|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177874|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177875|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177876|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177877|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177878|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177879|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177880|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177881|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177882|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177883|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177884|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177885|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177886|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177887|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177888|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177889|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177890|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177891|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177892|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177893|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177894|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177895|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177896|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177897|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177898|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177899|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177900|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177901|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177902|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177904|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177905|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177906|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177907|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177908|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177909|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177910|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177911|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177912|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177913|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177914|NCT01263483|E3|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177915|NCT01263483|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
177916|NCT01263483|E1|Reported Event|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177917|NCT01263470|B7|Baseline|Total|Total of all reporting groups
177918|NCT01263470|B6|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177919|NCT01263470|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177920|NCT01263470|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177921|NCT01263470|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177922|NCT01263470|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177923|NCT01263470|B1|Baseline|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177924|NCT01263470|P6|Participant Flow|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177925|NCT01263470|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177926|NCT01263470|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177927|NCT01263470|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177928|NCT01263470|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177929|NCT01263470|P1|Participant Flow|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177930|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177931|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177932|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177933|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177934|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177935|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177936|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177937|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177938|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177939|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177940|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177941|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177942|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177943|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177944|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177945|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177946|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177947|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177948|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177949|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177950|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177951|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177952|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177953|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177954|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177955|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177956|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177957|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177958|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177959|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177960|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177961|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177962|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177963|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177964|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177965|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177966|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177967|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177968|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177969|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177970|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177971|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177972|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177973|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177974|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177975|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177976|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177977|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177978|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177979|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177980|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177981|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177982|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177983|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177984|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177985|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177986|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177987|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177988|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177989|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177990|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177991|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177992|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177993|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
177994|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
177995|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
177996|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
177997|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
177998|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
177999|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178000|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178001|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178002|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
178003|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178004|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178005|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178006|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178007|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178008|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
192069|NCT01217112|O5|Outcome|Placebo|Contains excipients only
178009|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178010|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178011|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178012|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178013|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178014|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
178015|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178016|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178017|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178018|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178019|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178020|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
178021|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178022|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178023|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178024|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178025|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178026|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
178027|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178028|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178029|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178030|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178031|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178032|NCT01263470|E6|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
178033|NCT01263470|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
178034|NCT01263470|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
178035|NCT01263470|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
178036|NCT01263470|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
178037|NCT01263470|E1|Reported Event|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
178038|NCT01263444|B1|Baseline|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178039|NCT01263444|P1|Participant Flow|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178040|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178041|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178042|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178043|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178044|NCT01263444|E1|Reported Event|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
178045|NCT01263301|B3|Baseline|Total|Total of all reporting groups
178046|NCT01263301|B2|Baseline|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
178047|NCT01263301|B1|Baseline|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
178048|NCT01263301|P2|Participant Flow|Carotid Duplex for Hemodialytic Patients|"After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.~However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2."
178049|NCT01263301|P1|Participant Flow|Carotid Duplex for Nonhemidialytic Patients Wtih SSS|using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
178473|NCT01262352|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
178050|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow remained unchanged during the test
178051|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow remained unchanged during the test
178052|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow reversed to normal pattern during the test
178053|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow reversed to normal during the test
178054|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow remained unchanged during the cuff test
178055|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow remained unchanged during the cuff test
178056|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
178057|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test
178058|NCT01263301|E2|Reported Event|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
178059|NCT01263301|E1|Reported Event|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
178060|NCT01263132|B3|Baseline|Total|Total of all reporting groups
178061|NCT01263132|B2|Baseline|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178062|NCT01263132|B1|Baseline|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178063|NCT01263132|P2|Participant Flow|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178064|NCT01263132|P1|Participant Flow|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178065|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178066|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178067|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178068|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178069|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178070|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178071|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178072|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178073|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178431|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178074|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178075|NCT01263132|E2|Reported Event|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
178076|NCT01263132|E1|Reported Event|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
178077|NCT01263054|B3|Baseline|Total|Total of all reporting groups
178078|NCT01263054|B2|Baseline|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
178079|NCT01263054|B1|Baseline|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
178080|NCT01263054|P2|Participant Flow|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
178081|NCT01263054|P1|Participant Flow|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
178082|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178083|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178084|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178085|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178086|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178087|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178088|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178089|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178090|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178091|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178092|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178093|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178094|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
178095|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
178096|NCT01263054|E2|Reported Event|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
178097|NCT01263054|E1|Reported Event|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
178098|NCT01263028|B1|Baseline|Ergocalciferol Supplementation|
178099|NCT01263028|P1|Participant Flow|Ergocalciferol Supplementation|
178100|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
178101|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
178102|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
178103|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
178104|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
178105|NCT01263028|E1|Reported Event|Ergocalciferol Supplementation|
178106|NCT01263015|B3|Baseline|Total|Total of all reporting groups
178107|NCT01263015|B2|Baseline|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178108|NCT01263015|B1|Baseline|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178109|NCT01263015|P2|Participant Flow|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
178110|NCT01263015|P1|Participant Flow|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.
178111|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178112|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178113|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178114|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178115|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178116|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178117|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178118|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178119|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178120|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178121|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178122|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178123|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178124|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178125|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178339|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178614|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178126|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178127|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178128|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178129|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178130|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178131|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178132|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178133|NCT01263015|E2|Reported Event|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
178134|NCT01263015|E1|Reported Event|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
178135|NCT01262989|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
178136|NCT01262989|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
178137|NCT01262989|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
178138|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178139|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178140|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178141|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178142|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178143|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
178144|NCT01262989|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
178615|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178145|NCT01262989|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
178146|NCT01262872|B9|Baseline|Total|Total of all reporting groups
178147|NCT01262872|B8|Baseline|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178148|NCT01262872|B7|Baseline|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178149|NCT01262872|B6|Baseline|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178150|NCT01262872|B5|Baseline|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178151|NCT01262872|B4|Baseline|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178152|NCT01262872|B3|Baseline|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178153|NCT01262872|B2|Baseline|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178154|NCT01262872|B1|Baseline|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178155|NCT01262872|P8|Participant Flow|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178340|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178616|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
192209|NCT01217112|O5|Outcome|Placebo|Contains excipients only
178156|NCT01262872|P7|Participant Flow|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178157|NCT01262872|P6|Participant Flow|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178158|NCT01262872|P5|Participant Flow|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178159|NCT01262872|P4|Participant Flow|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178160|NCT01262872|P3|Participant Flow|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178161|NCT01262872|P2|Participant Flow|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178162|NCT01262872|P1|Participant Flow|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178163|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178164|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178165|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178432|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178166|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178167|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178168|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178169|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178170|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178171|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178172|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178173|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178183|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
196258|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
178174|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178175|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178176|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178177|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178178|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178179|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178180|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178181|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178182|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178435|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178184|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178185|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178186|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178187|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178188|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178189|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178190|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178191|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178192|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178193|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178194|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178195|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178196|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178197|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178198|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178199|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178200|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178201|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178433|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
196259|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
178202|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178203|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178204|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178205|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178206|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178207|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178208|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178209|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178210|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178211|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178212|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178213|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178214|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178215|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178216|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178217|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178218|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178219|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178434|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
196260|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
178220|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178221|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178222|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178223|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178224|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178225|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178226|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178227|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178228|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178229|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178230|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178231|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178232|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178233|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178234|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178235|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178236|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178254|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
196921|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
178237|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178238|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178239|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178240|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178241|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178242|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178243|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178244|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178255|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178245|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178246|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178247|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178248|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178249|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178250|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178251|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178252|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178253|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
200981|NCT01191762|B3|Baseline|Total|Total of all reporting groups
178256|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178257|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178258|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178259|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178260|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178261|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178262|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178263|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178264|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178265|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178266|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178267|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178268|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178269|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178270|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178271|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178272|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178273|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178336|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178274|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178275|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178276|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178277|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178278|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178279|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178280|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178281|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178282|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178283|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178284|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178285|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178286|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178287|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178288|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178289|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178290|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178291|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178337|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178292|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178293|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178294|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178295|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178296|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178297|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178298|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178299|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178300|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178301|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178302|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178303|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178304|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178305|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178306|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178307|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178308|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178309|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178338|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178310|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178311|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178312|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178313|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178314|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178315|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178316|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178317|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178318|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178319|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178320|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178321|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178322|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178323|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178324|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178325|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178326|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178327|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178328|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178329|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178330|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178331|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178332|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178333|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178334|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178335|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178469|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
178341|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178342|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178343|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178344|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178345|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178346|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178347|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178348|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178349|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178350|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178351|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178352|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178353|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178370|NCT01262755|P1|Participant Flow|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
178371|NCT01262755|O1|Outcome|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
178354|NCT01262872|E8|Reported Event|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178355|NCT01262872|E7|Reported Event|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178356|NCT01262872|E6|Reported Event|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178357|NCT01262872|E5|Reported Event|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178358|NCT01262872|E4|Reported Event|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178359|NCT01262872|E3|Reported Event|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
178360|NCT01262872|E2|Reported Event|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
178361|NCT01262872|E1|Reported Event|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
178362|NCT01262820|B1|Baseline|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178363|NCT01262820|P1|Participant Flow|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178364|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178365|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178366|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178367|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178368|NCT01262820|E1|Reported Event|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
178369|NCT01262755|B1|Baseline|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
178372|NCT01262755|E1|Reported Event|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
178373|NCT01262599|B3|Baseline|Total|Total of all reporting groups
178374|NCT01262599|B2|Baseline|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
178375|NCT01262599|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
178376|NCT01262599|P2|Participant Flow|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
178377|NCT01262599|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
178378|NCT01262599|O2|Outcome|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
178379|NCT01262599|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
178380|NCT01262599|E2|Reported Event|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
178381|NCT01262599|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
178382|NCT01262573|B3|Baseline|Total|Total of all reporting groups
178383|NCT01262573|B2|Baseline|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178384|NCT01262573|B1|Baseline|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178385|NCT01262573|P2|Participant Flow|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178386|NCT01262573|P1|Participant Flow|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178387|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178388|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178389|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178390|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178391|NCT01262573|E2|Reported Event|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178392|NCT01262573|E1|Reported Event|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
178393|NCT01262547|B1|Baseline|All Study Participants|"Dermabrasion-Micrografting, Dermabrasion and Control~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.~Control: Untreated depigmented area"
178394|NCT01262547|P1|Participant Flow|Patients With Vitiligo|Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
178395|NCT01262547|O3|Outcome|Control|Control
178396|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
178397|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
178398|NCT01262547|O3|Outcome|Control|Target sites did not receive any treatment
178399|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
178400|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
178401|NCT01262547|E3|Reported Event|Control|"Control~Depigmented areas that did not receive any treatment."
178402|NCT01262547|E2|Reported Event|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
178470|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
178403|NCT01262547|E1|Reported Event|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
178404|NCT01261507|B1|Baseline|Radiologists|Board Certified Radiologists working in the Washington, DC, Baltimore region
178405|NCT01261507|P1|Participant Flow|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
178406|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
178407|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
178408|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
178409|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
178410|NCT01261507|O2|Outcome|Radiologists Working With Software|Each radiologist serves as own control, working without and with software. This is the arm working with software
178411|NCT01261507|O1|Outcome|Board Certified Radiologists Working Without Software|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
178412|NCT01261507|E1|Reported Event|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
178413|NCT01262456|B4|Baseline|Total|Total of all reporting groups
178414|NCT01262456|B3|Baseline|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178415|NCT01262456|B2|Baseline|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178416|NCT01262456|B1|Baseline|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178417|NCT01262456|P3|Participant Flow|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
178418|NCT01262456|P2|Participant Flow|50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
178419|NCT01262456|P1|Participant Flow|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
178420|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178421|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178422|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178423|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178424|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178425|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178426|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178427|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178428|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178429|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178430|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178436|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178437|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178438|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178439|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178440|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178441|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178442|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178443|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178444|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178445|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178446|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178447|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178448|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178449|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178450|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178451|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178452|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178453|NCT01262456|E6|Reported Event|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178454|NCT01262456|E5|Reported Event|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178455|NCT01262456|E4|Reported Event|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
178456|NCT01262456|E3|Reported Event|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178457|NCT01262456|E2|Reported Event|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178458|NCT01262456|E1|Reported Event|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
178459|NCT01262352|B3|Baseline|Total|Total of all reporting groups
178460|NCT01262352|B2|Baseline|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
178461|NCT01262352|B1|Baseline|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
178462|NCT01262352|P2|Participant Flow|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
178463|NCT01262352|P1|Participant Flow|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
178464|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
178465|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
178466|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
178467|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
178468|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
178474|NCT01262339|B1|Baseline|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
178475|NCT01262339|P1|Participant Flow|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
178476|NCT01262339|O1|Outcome|Active Comparator: Comparator of Hand A Intervention vs Hand B|Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
178477|NCT01262339|E1|Reported Event|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
178478|NCT01262287|B3|Baseline|Total|Total of all reporting groups
178479|NCT01262287|B2|Baseline|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
178480|NCT01262287|B1|Baseline|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
178481|NCT01262287|P2|Participant Flow|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
178482|NCT01262287|P1|Participant Flow|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
178483|NCT01262287|O4|Outcome|AKR1C3*2 G-carriers + Placebo|AKR1C3*2 G-carriers in placebo arm
178484|NCT01262287|O3|Outcome|AKR1C3*2 G-carriers + Dutasteride|AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
178485|NCT01262287|O2|Outcome|AKR1C3*2 C/C Genotype + Placebo|"AKR1C3*2 C/C genotype subjects in placebo arm~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
178486|NCT01262287|O1|Outcome|AKR1C3*2 C/C Genotype + Dutasteride|AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)
178487|NCT01262287|O2|Outcome|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
178488|NCT01262287|O1|Outcome|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
178489|NCT01262287|E2|Reported Event|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
178490|NCT01262287|E1|Reported Event|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
178491|NCT01262131|B4|Baseline|Total|Total of all reporting groups
178492|NCT01262131|B3|Baseline|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
178493|NCT01262131|B2|Baseline|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
178494|NCT01262131|B1|Baseline|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
178495|NCT01262131|P3|Participant Flow|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
178496|NCT01262131|P2|Participant Flow|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
178497|NCT01262131|P1|Participant Flow|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
178498|NCT01262131|O3|Outcome|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
178499|NCT01262131|O2|Outcome|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
178500|NCT01262131|O1|Outcome|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
178501|NCT01262131|E3|Reported Event|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
178502|NCT01262131|E2|Reported Event|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
178503|NCT01262131|E1|Reported Event|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
178504|NCT01262118|B3|Baseline|Total|Total of all reporting groups
178505|NCT01262118|B2|Baseline|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178506|NCT01262118|B1|Baseline|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178507|NCT01262118|P2|Participant Flow|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178508|NCT01262118|P1|Participant Flow|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178509|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178510|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178511|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178617|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
203994|NCT01183312|E2|Reported Event|Sublingual Flumazenil|
178512|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178513|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178514|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178515|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178516|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178517|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178518|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178519|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178520|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178521|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178522|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178523|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178524|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178525|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178526|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178527|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178528|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178529|NCT01262118|E2|Reported Event|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
178530|NCT01262118|E1|Reported Event|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
178531|NCT01262105|B3|Baseline|Total|Total of all reporting groups
178532|NCT01262105|B2|Baseline|Device Deployed|
178533|NCT01262105|B1|Baseline|No Device|
178534|NCT01262105|P2|Participant Flow|Device Deployed|
178535|NCT01262105|P1|Participant Flow|No Device|
178536|NCT01262105|O2|Outcome|Device Deployed|The ABS device is employed during surgery.
178537|NCT01262105|O1|Outcome|No Device|No device is deployed during surgery
178538|NCT01262105|E2|Reported Event|Device Deployed|
178539|NCT01262105|E1|Reported Event|No Device|
178540|NCT01262092|B3|Baseline|Total|Total of all reporting groups
178541|NCT01262092|B2|Baseline|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
178542|NCT01262092|B1|Baseline|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
178543|NCT01262092|P2|Participant Flow|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
178544|NCT01262092|P1|Participant Flow|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
178545|NCT01262092|O2|Outcome|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
178546|NCT01262092|O1|Outcome|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
178547|NCT01262092|E2|Reported Event|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
178548|NCT01262092|E1|Reported Event|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
178549|NCT01262027|B1|Baseline|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
178550|NCT01262027|P1|Participant Flow|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
178618|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178551|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
178552|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
178553|NCT01262027|E1|Reported Event|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
178554|NCT01261975|B1|Baseline|Cataract Surgery|Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
178555|NCT01261975|P1|Participant Flow|Cataract Surgery|Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
178556|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178557|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178558|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178559|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178560|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178561|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178562|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178563|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178564|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178565|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178566|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178567|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178568|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178569|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
178570|NCT01261975|E3|Reported Event|Cataract Surgery All Participants|Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
178571|NCT01261975|E2|Reported Event|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
178572|NCT01261975|E1|Reported Event|Co-Axial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
178573|NCT01261624|B3|Baseline|Total|Total of all reporting groups
178574|NCT01261624|B2|Baseline|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
178575|NCT01261624|B1|Baseline|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID|Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
178576|NCT01261624|P2|Participant Flow|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
178577|NCT01261624|P1|Participant Flow|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)|Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
178578|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
178579|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
178580|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
178581|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
178582|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
178688|NCT01260883|B4|Baseline|Total|Total of all reporting groups
178583|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
178584|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
178585|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
178586|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
178587|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
178588|NCT01261624|E5|Reported Event|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
178589|NCT01261624|E4|Reported Event|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
178590|NCT01261624|E3|Reported Event|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
178591|NCT01261624|E2|Reported Event|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
178592|NCT01261624|E1|Reported Event|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
178593|NCT01261559|B3|Baseline|Total|Total of all reporting groups
178594|NCT01261559|B2|Baseline|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
178595|NCT01261559|B1|Baseline|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
178596|NCT01261559|P2|Participant Flow|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
178597|NCT01261559|P1|Participant Flow|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
178598|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
178599|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
178600|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
178601|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
178602|NCT01261559|E2|Reported Event|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
178603|NCT01261559|E1|Reported Event|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
178604|NCT01261325|B4|Baseline|Total Title|
178605|NCT01261325|B3|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178606|NCT01261325|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178607|NCT01261325|B1|Baseline|Placebo|Matching placebo tablets administered twice daily
178608|NCT01261325|P3|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178609|NCT01261325|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178610|NCT01261325|P1|Participant Flow|Placebo|Matching placebo tablets administered twice daily
178611|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178612|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178613|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178619|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178620|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178621|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178622|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178623|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178624|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178625|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178626|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178627|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178628|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178629|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178630|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178631|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178632|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178633|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178634|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
178635|NCT01261325|O3|Outcome|Placebo|Matching placebo tablets administered twice daily
178636|NCT01261325|O2|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178637|NCT01261325|O1|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178638|NCT01261325|E3|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
178639|NCT01261325|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
178640|NCT01261325|E1|Reported Event|Placebo|Matching placebo tablets administered twice daily
178641|NCT01261052|B1|Baseline|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
178642|NCT01261052|P1|Participant Flow|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
178643|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
178644|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
178645|NCT01261052|E2|Reported Event|FMPD/APD Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
178646|NCT01261052|E1|Reported Event|APD Only Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
178647|NCT01260948|B3|Baseline|Total|Total of all reporting groups
178648|NCT01260948|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178649|NCT01260948|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178650|NCT01260948|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178651|NCT01260948|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178652|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
178653|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
178654|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
178655|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
178656|NCT01260948|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178657|NCT01260948|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178658|NCT01260922|B3|Baseline|Total|Total of all reporting groups
178659|NCT01260922|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178660|NCT01260922|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178661|NCT01260922|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178662|NCT01260922|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178663|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
178664|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
178665|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
178666|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
178667|NCT01260922|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
178668|NCT01260922|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
178669|NCT01260896|B3|Baseline|Total|Total of all reporting groups
178670|NCT01260896|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
178671|NCT01260896|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
178672|NCT01260896|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
178673|NCT01260896|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
178674|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178675|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178676|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178677|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178678|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178679|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178680|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178681|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178682|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178683|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178684|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
178685|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
178686|NCT01260896|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
178687|NCT01260896|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
178689|NCT01260883|B3|Baseline|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
178690|NCT01260883|B2|Baseline|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
178691|NCT01260883|B1|Baseline|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
178692|NCT01260883|P3|Participant Flow|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
178693|NCT01260883|P2|Participant Flow|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
178694|NCT01260883|P1|Participant Flow|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
178695|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
178696|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac after surgery
178697|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
178698|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac infusion after surgery
178699|NCT01260883|O3|Outcome|Placebo|noncompartmental analysis of stereo-isomers of ketorolac
178700|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|noncompartmental analysis of stereo-isomers of ketorolac
178701|NCT01260883|O1|Outcome|S- Ketorolac Half-life|noncompartmental ketorolac analysis
178702|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178703|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178704|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
178705|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178706|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178707|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution Central|stereo-specific ketorolac analysis by NONMEM
178708|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178709|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178710|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac analysis by NONMEM
178711|NCT01260883|O2|Outcome|Placebo|infants given placebo intravenously after surgery
178712|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants given ketorolac intravenously after surgery
178713|NCT01260883|O2|Outcome|Placebo|infants receiving placebo infusion intravenously after surgery
178714|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving active drug intravenously after surgery
178715|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178716|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178717|NCT01260883|O1|Outcome|S- Ketorolac Half-life|stereo-specific ketorolac analysis by NONMEM
178718|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178719|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178720|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
178721|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178722|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
178723|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Central|stereo-specific ketorolac analysis by NONMEM
178724|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
178725|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
178726|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration, analyzed by NONMEM population pharmacokinetic methodology
178727|NCT01260883|E3|Reported Event|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
178728|NCT01260883|E2|Reported Event|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
178729|NCT01260883|E1|Reported Event|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
178730|NCT01260701|B1|Baseline|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178731|NCT01260701|P1|Participant Flow|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178732|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178733|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178734|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178735|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178736|NCT01260701|E1|Reported Event|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178737|NCT01260688|B3|Baseline|Total|Total of all reporting groups
178738|NCT01260688|B2|Baseline|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178796|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178739|NCT01260688|B1|Baseline|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178740|NCT01260688|P2|Participant Flow|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178741|NCT01260688|P1|Participant Flow|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178742|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178743|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
178744|NCT01260688|E2|Reported Event|Arm II - Cediranib Alone|
178745|NCT01260688|E1|Reported Event|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
178746|NCT01260662|B4|Baseline|Total|Total of all reporting groups
178747|NCT01260662|B3|Baseline|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178748|NCT01260662|B2|Baseline|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178749|NCT01260662|B1|Baseline|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178750|NCT01260662|P3|Participant Flow|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178751|NCT01260662|P2|Participant Flow|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178752|NCT01260662|P1|Participant Flow|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178753|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178754|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178755|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178756|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178757|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178758|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178759|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178760|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178761|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178762|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178763|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178764|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178765|NCT01260662|E3|Reported Event|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178797|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178766|NCT01260662|E2|Reported Event|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178767|NCT01260662|E1|Reported Event|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
178768|NCT01260584|B5|Baseline|Total|Total of all reporting groups
178769|NCT01260584|B4|Baseline|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178770|NCT01260584|B3|Baseline|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178771|NCT01260584|B2|Baseline|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178772|NCT01260584|B1|Baseline|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178773|NCT01260584|P4|Participant Flow|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178774|NCT01260584|P3|Participant Flow|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178775|NCT01260584|P2|Participant Flow|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178776|NCT01260584|P1|Participant Flow|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
178777|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178778|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178779|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178780|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178781|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178782|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178783|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178784|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178785|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178786|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178787|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178788|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178789|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178790|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178791|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178792|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178793|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178794|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178795|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178798|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178799|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178800|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178801|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
178802|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
178803|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
178804|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178805|NCT01260584|E4|Reported Event|Clopidogrel Non-Smokers|"participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not at risk."
178806|NCT01260584|E3|Reported Event|Clopidogrel Smokers|"participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not At risk."
178807|NCT01260584|E2|Reported Event|Prasugrel Non-Smokers|"participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not at risk."
178808|NCT01260584|E1|Reported Event|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
178809|NCT01260493|B3|Baseline|Total|Total of all reporting groups
178810|NCT01260493|B2|Baseline|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
178811|NCT01260493|B1|Baseline|Conventional Care, Controlgroup|conventional care, control group
178812|NCT01260493|P2|Participant Flow|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
178813|NCT01260493|P1|Participant Flow|Conventional Care, Controlgroup|conventional care, control group
178814|NCT01260493|O2|Outcome|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
178815|NCT01260493|O1|Outcome|Conventional Care, Controlgroup|conventional care, control group
178816|NCT01260493|E2|Reported Event|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
178817|NCT01260493|E1|Reported Event|Conventional Care, Controlgroup|conventional care, control group
178818|NCT01260467|B1|Baseline|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
178819|NCT01260467|P1|Participant Flow|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
178820|NCT01260467|O1|Outcome|Single Arm|No adverse events reported.
178821|NCT01260467|O1|Outcome|Memantine Arm|memantine: 10 milligrams orally twice a day
178822|NCT01260467|O1|Outcome|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
178823|NCT01260467|E1|Reported Event|Single Agent Memantine Group|NO data to report
178824|NCT01260454|B1|Baseline|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178825|NCT01260454|P1|Participant Flow|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178826|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178827|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178828|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178829|NCT01260454|E1|Reported Event|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
178830|NCT01260350|B21|Baseline|Total|Total of all reporting groups
181416|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
178831|NCT01260350|B20|Baseline|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
178832|NCT01260350|B19|Baseline|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178833|NCT01260350|B18|Baseline|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178834|NCT01260350|B17|Baseline|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178835|NCT01260350|B16|Baseline|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178836|NCT01260350|B15|Baseline|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178837|NCT01260350|B14|Baseline|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178838|NCT01260350|B13|Baseline|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178839|NCT01260350|B12|Baseline|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178840|NCT01260350|B11|Baseline|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178841|NCT01260350|B10|Baseline|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178842|NCT01260350|B9|Baseline|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178843|NCT01260350|B8|Baseline|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178844|NCT01260350|B7|Baseline|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178845|NCT01260350|B6|Baseline|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178846|NCT01260350|B5|Baseline|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178847|NCT01260350|B4|Baseline|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178848|NCT01260350|B3|Baseline|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178849|NCT01260350|B2|Baseline|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178850|NCT01260350|B1|Baseline|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178851|NCT01260350|P22|Participant Flow|Group 22: LDV/SOF FDC 6 wk: GT 1, TN|Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
178852|NCT01260350|P21|Participant Flow|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
178853|NCT01260350|P20|Participant Flow|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178854|NCT01260350|P19|Participant Flow|Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178855|NCT01260350|P18|Participant Flow|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178856|NCT01260350|P17|Participant Flow|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178857|NCT01260350|P16|Participant Flow|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178858|NCT01260350|P15|Participant Flow|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179591|NCT01258803|E2|Reported Event|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
178859|NCT01260350|P14|Participant Flow|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178860|NCT01260350|P13|Participant Flow|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178861|NCT01260350|P12|Participant Flow|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178862|NCT01260350|P11|Participant Flow|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178863|NCT01260350|P10|Participant Flow|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178864|NCT01260350|P9|Participant Flow|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178865|NCT01260350|P8|Participant Flow|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178866|NCT01260350|P7|Participant Flow|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178867|NCT01260350|P6|Participant Flow|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178868|NCT01260350|P5|Participant Flow|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178869|NCT01260350|P4|Participant Flow|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178870|NCT01260350|P3|Participant Flow|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178871|NCT01260350|P2|Participant Flow|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178872|NCT01260350|P1|Participant Flow|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178873|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
178874|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178875|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178876|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178877|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178878|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178879|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178880|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178881|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178882|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178883|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178884|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178885|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178886|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178887|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178888|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178889|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178890|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178891|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178892|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178893|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178894|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178895|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178896|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178897|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178898|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178899|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178900|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178901|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178902|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178903|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178904|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178905|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178906|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178907|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178908|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178909|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178910|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178911|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178912|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178913|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178914|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
182202|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
178915|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178916|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178917|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178918|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178919|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178920|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178921|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178922|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178923|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178924|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178925|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
178926|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178927|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178928|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178929|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178930|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178931|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178932|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178933|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178934|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178935|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178936|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178937|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178938|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178939|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178940|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178941|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178942|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178943|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178944|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178945|NCT01260350|O17|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178946|NCT01260350|O16|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178947|NCT01260350|O15|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178948|NCT01260350|O14|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178949|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178950|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178951|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178952|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178953|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178954|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178955|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178956|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178957|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178958|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178959|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178960|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178961|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178962|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178963|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178964|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178965|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178966|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178967|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178968|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178969|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178970|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178971|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
183237|NCT01247220|B2|Baseline|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
178972|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178973|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178974|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178975|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178976|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178977|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178978|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178979|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178980|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
178981|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
178982|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
178983|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178984|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178985|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
178986|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178987|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178988|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178989|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
178990|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178991|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178992|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
178993|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
178994|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
178995|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178996|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178997|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178998|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
178999|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179000|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
179001|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
179002|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
179003|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179004|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179005|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179006|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179007|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179008|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179009|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179010|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179011|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179012|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
179013|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179014|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
179015|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179016|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179017|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179018|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179019|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179020|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
179021|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
179022|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
179023|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179024|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179025|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179026|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179027|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179028|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179592|NCT01258803|E1|Reported Event|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179029|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179030|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179031|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179032|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
179033|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179034|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
179035|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179036|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179037|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179038|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179039|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179040|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
179041|NCT01260350|E20|Reported Event|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
179042|NCT01260350|E19|Reported Event|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
179043|NCT01260350|E18|Reported Event|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179044|NCT01260350|E17|Reported Event|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179045|NCT01260350|E16|Reported Event|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
179046|NCT01260350|E15|Reported Event|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179047|NCT01260350|E14|Reported Event|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179048|NCT01260350|E13|Reported Event|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179049|NCT01260350|E12|Reported Event|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
179050|NCT01260350|E11|Reported Event|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179051|NCT01260350|E10|Reported Event|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179052|NCT01260350|E9|Reported Event|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
179053|NCT01260350|E8|Reported Event|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
179054|NCT01260350|E7|Reported Event|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
179055|NCT01260350|E6|Reported Event|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179056|NCT01260350|E5|Reported Event|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179593|NCT01258790|B3|Baseline|Total|Total of all reporting groups
183304|NCT01245595|B2|Baseline|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
179057|NCT01260350|E4|Reported Event|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179058|NCT01260350|E3|Reported Event|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179059|NCT01260350|E2|Reported Event|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
179060|NCT01260350|E1|Reported Event|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
179061|NCT01260324|B3|Baseline|Total|Total of all reporting groups
179062|NCT01260324|B2|Baseline|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
179063|NCT01260324|B1|Baseline|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
179064|NCT01260324|P2|Participant Flow|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
179065|NCT01260324|P1|Participant Flow|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
179066|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
179067|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
179068|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
179069|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179070|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179071|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179072|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179073|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179116|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179853|NCT01258387|B3|Baseline|GGF2 Second Escalated Dose|Second dosing: patients in cohort randomized to GGF2
203995|NCT01183312|E1|Reported Event|Placebo|
179074|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179075|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
179076|NCT01260324|E2|Reported Event|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
179077|NCT01260324|E1|Reported Event|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
179078|NCT01260311|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179079|NCT01260311|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179080|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179081|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179082|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179083|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179084|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179085|NCT01260311|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
179086|NCT01260272|B3|Baseline|Total|Total of all reporting groups
179087|NCT01260272|B2|Baseline|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179088|NCT01260272|B1|Baseline|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179089|NCT01260272|P2|Participant Flow|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179090|NCT01260272|P1|Participant Flow|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179091|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179117|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179144|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179092|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179093|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179094|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179095|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179096|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179097|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179098|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179099|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179100|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179101|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179118|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179119|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179210|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179102|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179103|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179104|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179105|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179106|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179107|NCT01260272|E2|Reported Event|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
179108|NCT01260272|E1|Reported Event|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
179109|NCT01260194|B1|Baseline|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179110|NCT01260194|P1|Participant Flow|Trastuzumab|Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179111|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179112|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179113|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179114|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179115|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179120|NCT01260194|E1|Reported Event|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
179121|NCT01260142|B7|Baseline|Total|Total of all reporting groups
179122|NCT01260142|B6|Baseline|Cohort 3 ( Sequence F)|Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
179123|NCT01260142|B5|Baseline|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
179124|NCT01260142|B4|Baseline|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
179125|NCT01260142|B3|Baseline|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
179126|NCT01260142|B2|Baseline|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
179127|NCT01260142|B1|Baseline|Cohort 1 (Sequence A)|Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
179128|NCT01260142|P6|Participant Flow|Cohort 3 (Sequence F)|Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
179129|NCT01260142|P5|Participant Flow|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
179130|NCT01260142|P4|Participant Flow|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
179131|NCT01260142|P3|Participant Flow|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
179132|NCT01260142|P2|Participant Flow|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
179133|NCT01260142|P1|Participant Flow|Cohort 1 (Sequence A)|Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
179134|NCT01260142|O3|Outcome|Cohort 3 (Fospropofol 15.0 : Propofol 1.5)|"Cohort 3 (Sequence E): participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.~Cohort (Sequence F): participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium."
179135|NCT01260142|O2|Outcome|Cohort 2 (Fospropofol 10.0 : Propofol 1.0)|"Cohort 2 (Sequence C): Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.~Cohort 2 (Sequence D): Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium."
179136|NCT01260142|O1|Outcome|Cohort 1 (Fospropofol 6.5 : Propofol 0.65)|"Cohort 1 (Sequence A): participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.~Cohort 1: Sequence B: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium."
179137|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179138|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179139|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179140|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179141|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179142|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179143|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179211|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179145|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179146|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179147|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179148|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179149|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179150|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179151|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179152|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179153|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179154|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179155|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179156|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179157|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179158|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179159|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179160|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179161|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179162|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179163|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179164|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179165|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179166|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179167|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179168|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179169|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179170|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179171|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179172|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179173|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179174|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179175|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179176|NCT01260142|E6|Reported Event|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
179177|NCT01260142|E5|Reported Event|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
179178|NCT01260142|E4|Reported Event|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
179179|NCT01260142|E3|Reported Event|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
179180|NCT01260142|E2|Reported Event|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
179181|NCT01260142|E1|Reported Event|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
179182|NCT01259726|B5|Baseline|Total|Total of all reporting groups
179183|NCT01259726|B4|Baseline|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179184|NCT01259726|B3|Baseline|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179185|NCT01259726|B2|Baseline|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179186|NCT01259726|B1|Baseline|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179187|NCT01259726|P4|Participant Flow|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179188|NCT01259726|P3|Participant Flow|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179189|NCT01259726|P2|Participant Flow|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179190|NCT01259726|P1|Participant Flow|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179191|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179192|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179193|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179194|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179195|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179196|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179197|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179198|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179199|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179200|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179201|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179202|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179203|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179204|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179205|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179206|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179207|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
179208|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179209|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179212|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179213|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
179214|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
179215|NCT01259726|E4|Reported Event|VP20621 High Dose|VP20621: VP20621 as oral liquid once daily for 14 days
179216|NCT01259726|E3|Reported Event|VP20621 High Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
179217|NCT01259726|E2|Reported Event|VP20621 Low Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
179218|NCT01259726|E1|Reported Event|Placebo|Placebo: 10 mL placebo once daily for 14 days
179219|NCT01259713|B3|Baseline|Total|Total of all reporting groups
179220|NCT01259713|B2|Baseline|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179221|NCT01259713|B1|Baseline|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179222|NCT01259713|P2|Participant Flow|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179223|NCT01259713|P1|Participant Flow|Liposomal Amphotericin B|Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179224|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179225|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179226|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179227|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179228|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179229|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179230|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179231|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179232|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179233|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179234|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179235|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179236|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179237|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179238|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179239|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179240|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179241|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179242|NCT01259713|E2|Reported Event|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179448|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179243|NCT01259713|E1|Reported Event|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
179244|NCT01259492|B5|Baseline|Total|Total of all reporting groups
179245|NCT01259492|B4|Baseline|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179246|NCT01259492|B3|Baseline|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179247|NCT01259492|B2|Baseline|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179248|NCT01259492|B1|Baseline|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179249|NCT01259492|P4|Participant Flow|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179250|NCT01259492|P3|Participant Flow|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179251|NCT01259492|P2|Participant Flow|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179252|NCT01259492|P1|Participant Flow|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179253|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179254|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179854|NCT01258387|B2|Baseline|GGF2 First Dose|First dosing: patients in cohort randomized to GGF2
179255|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179256|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179257|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179258|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179259|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179260|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179261|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179262|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179263|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179264|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179449|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179855|NCT01258387|B1|Baseline|Placebo|Patients in each of 7 cohorts randomized to Placebo
179265|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179266|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179267|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179268|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179269|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179270|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179271|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179272|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179273|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179274|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179342|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
179450|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179275|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179276|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179277|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
179278|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
179279|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
179280|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179281|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179282|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179283|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179284|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179285|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179286|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179324|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179287|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179288|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179289|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179290|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179291|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179292|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179293|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179294|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179295|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179296|NCT01259492|E2|Reported Event|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
179325|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
179590|NCT01258803|E3|Reported Event|F DPI|Participants receiving a single dose of F DPI 20 mcg
179297|NCT01259492|E1|Reported Event|All Ritalin LA|"All Ritalin LA:~In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose."
179298|NCT01259466|B3|Baseline|Total|Total of all reporting groups
179299|NCT01259466|B2|Baseline|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179300|NCT01259466|B1|Baseline|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179301|NCT01259466|P2|Participant Flow|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179302|NCT01259466|P1|Participant Flow|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179303|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179304|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179305|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179306|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179307|NCT01259466|E2|Reported Event|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179308|NCT01259466|E1|Reported Event|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
179309|NCT01259440|B3|Baseline|Total|Total of all reporting groups
179310|NCT01259440|B2|Baseline|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
179311|NCT01259440|B1|Baseline|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
179312|NCT01259440|P2|Participant Flow|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
179313|NCT01259440|P1|Participant Flow|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
179314|NCT01259440|O2|Outcome|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
179315|NCT01259440|O1|Outcome|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
179316|NCT01259440|E2|Reported Event|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
179317|NCT01259440|E1|Reported Event|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
179318|NCT01259427|B3|Baseline|Total|Total of all reporting groups
179319|NCT01259427|B2|Baseline|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
179320|NCT01259427|B1|Baseline|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179321|NCT01259427|P2|Participant Flow|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
179322|NCT01259427|P1|Participant Flow|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179323|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
179341|NCT01259401|P1|Participant Flow|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
203996|NCT01183234|B3|Baseline|Total|Total of all reporting groups
179326|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179327|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
179328|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179329|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
179330|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179331|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
179332|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179333|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
179334|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179335|NCT01259427|E2|Reported Event|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
179336|NCT01259427|E1|Reported Event|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
179337|NCT01259401|B3|Baseline|Total|Total of all reporting groups
179338|NCT01259401|B2|Baseline|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
179339|NCT01259401|B1|Baseline|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
179340|NCT01259401|P2|Participant Flow|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
179444|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179343|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
179344|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
179345|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
179346|NCT01259401|E2|Reported Event|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
179347|NCT01259401|E1|Reported Event|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
179348|NCT01259297|B9|Baseline|Total|Total of all reporting groups
179349|NCT01259297|B8|Baseline|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
179350|NCT01259297|B7|Baseline|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were run-in stratum randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
179351|NCT01259297|B6|Baseline|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179352|NCT01259297|B5|Baseline|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
179353|NCT01259297|B4|Baseline|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
179354|NCT01259297|B3|Baseline|Aliskiren + Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
179355|NCT01259297|B2|Baseline|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179356|NCT01259297|B1|Baseline|Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
179357|NCT01259297|P8|Participant Flow|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
179358|NCT01259297|P7|Participant Flow|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
179359|NCT01259297|P6|Participant Flow|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179360|NCT01259297|P5|Participant Flow|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
179361|NCT01259297|P4|Participant Flow|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
179362|NCT01259297|P3|Participant Flow|Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
183992|NCT01244516|P3|Participant Flow|Comfilcon A|comfilcon A, base curve 8.60
179363|NCT01259297|P2|Participant Flow|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179364|NCT01259297|P1|Participant Flow|Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
179365|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179366|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179367|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179368|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179369|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179370|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179371|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179372|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179373|NCT01259297|O2|Outcome|Placebo|This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine .
179374|NCT01259297|O1|Outcome|Aliskiren+Amlodipine/HCTZ Group|This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine.
179375|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179376|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179377|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179378|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179379|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
179380|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
179381|NCT01259297|E10|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for Amlod|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
179382|NCT01259297|E9|Reported Event|Double Blind Period: Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
179383|NCT01259297|E8|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179445|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179384|NCT01259297|E7|Reported Event|Double Blind Period: HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
179385|NCT01259297|E6|Reported Event|Double Blind Period: Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
179386|NCT01259297|E5|Reported Event|Double Blind Period: Aliskiren + Amlodipine|"In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
179387|NCT01259297|E4|Reported Event|Double Blind Period: Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
179388|NCT01259297|E3|Reported Event|Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
179389|NCT01259297|E2|Reported Event|Run-in Period: Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
179390|NCT01259297|E1|Reported Event|Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
179391|NCT01259284|B4|Baseline|Total|Total of all reporting groups
179392|NCT01259284|B3|Baseline|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
179393|NCT01259284|B2|Baseline|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
179394|NCT01259284|B1|Baseline|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
179395|NCT01259284|P3|Participant Flow|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
179396|NCT01259284|P2|Participant Flow|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
179397|NCT01259284|P1|Participant Flow|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
179398|NCT01259284|O3|Outcome|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
179399|NCT01259284|O2|Outcome|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
179400|NCT01259284|O1|Outcome|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
179401|NCT01259284|E3|Reported Event|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
179402|NCT01259284|E2|Reported Event|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
179403|NCT01259284|E1|Reported Event|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
179404|NCT01259245|B3|Baseline|Total|Total of all reporting groups
179405|NCT01259245|B2|Baseline|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179406|NCT01259245|B1|Baseline|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179407|NCT01259245|P2|Participant Flow|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179408|NCT01259245|P1|Participant Flow|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179446|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179409|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179410|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179411|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179412|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179413|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179414|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179415|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179416|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179417|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179418|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179419|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179447|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179420|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179421|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179422|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179423|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179424|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179425|NCT01259245|O2|Outcome|PRP+Tai Chi|
179426|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|
179427|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
179428|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
179429|NCT01259245|E2|Reported Event|Pulmonary Rehabilitation Program PRP|Subjects who received formal pulmonary rehabilitation program
179430|NCT01259245|E1|Reported Event|PRP + Tai Chi|Tai Chi elements added to PRP program
179431|NCT01259115|B1|Baseline|Overall Study|Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
179432|NCT01259115|P2|Participant Flow|Sequence B: BTDS 10 With Placebo (Reference) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily."
179433|NCT01259115|P1|Participant Flow|Sequence A: BTDS 10 With Ketoconazole (Test) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole placebo tablets twice daily."
179434|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
179435|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
179436|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
179437|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
179438|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
179439|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
179440|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
179441|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
179442|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179443|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
204845|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
179451|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179452|NCT01259115|O1|Outcome|All Subjects|Subjects who received BTDS with Ketoconazole treatment
179453|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179454|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179455|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179456|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179457|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179458|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179459|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
179460|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
179461|NCT01259115|E2|Reported Event|BTDS With Placebo|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
179462|NCT01259115|E1|Reported Event|BTDS With Ketoconazole|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily.
179463|NCT01259102|B6|Baseline|Total|Total of all reporting groups
179464|NCT01259102|B5|Baseline|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179465|NCT01259102|B4|Baseline|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179466|NCT01259102|B3|Baseline|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179467|NCT01259102|B2|Baseline|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179468|NCT01259102|B1|Baseline|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179469|NCT01259102|P5|Participant Flow|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179470|NCT01259102|P4|Participant Flow|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179471|NCT01259102|P3|Participant Flow|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179472|NCT01259102|P2|Participant Flow|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179473|NCT01259102|P1|Participant Flow|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179474|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179475|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179476|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179477|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179478|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179479|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179480|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179481|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179482|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179483|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179484|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179485|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179486|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179487|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179488|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179489|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179490|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179491|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179492|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179493|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179494|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179495|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179496|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
204846|NCT01181011|O2|Outcome|Telmisartan 80mg|
179497|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179498|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179499|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179500|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179501|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179502|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179503|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179504|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179505|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179506|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179507|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179508|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179509|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179510|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179511|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179512|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179513|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179514|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179515|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179516|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
204847|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
179517|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179518|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179519|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179520|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179521|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179522|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179523|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179524|NCT01259102|E5|Reported Event|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
179525|NCT01259102|E4|Reported Event|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
179526|NCT01259102|E3|Reported Event|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
179527|NCT01259102|E2|Reported Event|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
179528|NCT01259102|E1|Reported Event|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
179529|NCT01258998|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
179530|NCT01258998|P1|Participant Flow|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
179531|NCT01258998|O1|Outcome|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
179532|NCT01258998|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
179533|NCT01258985|B3|Baseline|Total|Total of all reporting groups
179534|NCT01258985|B2|Baseline|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179535|NCT01258985|B1|Baseline|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179536|NCT01258985|P2|Participant Flow|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179537|NCT01258985|P1|Participant Flow|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179538|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179539|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179540|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179541|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179542|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179543|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179544|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179545|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179546|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179547|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179548|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179549|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179550|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179551|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179552|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179553|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179554|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179555|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179556|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179557|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179558|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179559|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179560|NCT01258985|E2|Reported Event|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
179561|NCT01258985|E1|Reported Event|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
179562|NCT01258803|B1|Baseline|All Randomized Participants|
179563|NCT01258803|P6|Participant Flow|Treatment Sequence 6|Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
179564|NCT01258803|P5|Participant Flow|Treatment Sequence 5|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
179565|NCT01258803|P4|Participant Flow|Treatment Sequence 4|Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
179566|NCT01258803|P3|Participant Flow|Treatment Sequence 3|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
179567|NCT01258803|P2|Participant Flow|Treatment Sequence 2|Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
179568|NCT01258803|P1|Participant Flow|Treatment Sequence 1|Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
179569|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179570|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
179571|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
179572|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179573|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179574|NCT01258803|O1|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
179575|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
179576|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
179577|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
179578|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179579|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179580|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
179581|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
179582|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179583|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
179584|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179585|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179586|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
179587|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179588|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
179589|NCT01258803|E4|Reported Event|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
179594|NCT01258790|B2|Baseline|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179595|NCT01258790|B1|Baseline|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179596|NCT01258790|P2|Participant Flow|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179597|NCT01258790|P1|Participant Flow|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179598|NCT01258790|O2|Outcome|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179599|NCT01258790|O1|Outcome|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179600|NCT01258790|E2|Reported Event|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179601|NCT01258790|E1|Reported Event|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
179602|NCT01258738|B3|Baseline|Total|Total of all reporting groups
179603|NCT01258738|B2|Baseline|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179604|NCT01258738|B1|Baseline|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179605|NCT01258738|P2|Participant Flow|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179606|NCT01258738|P1|Participant Flow|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179607|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179608|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179609|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179610|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179611|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179612|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
204848|NCT01181011|O2|Outcome|Telmisartan 80mg|
179613|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179614|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179615|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179616|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179617|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179618|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179619|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179620|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179621|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179622|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179623|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179624|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179625|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179626|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179627|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179628|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179629|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179630|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179631|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179632|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179633|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179634|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179635|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179636|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179637|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179638|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179639|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179640|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179641|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179642|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179643|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179644|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179645|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179646|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179647|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179648|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179649|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179650|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179651|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179652|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179653|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179654|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179655|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179656|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179657|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179658|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179659|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179660|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179661|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179662|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179663|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179664|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179665|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179666|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179667|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179668|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179669|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179670|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179671|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179672|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179673|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179674|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179675|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179676|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179677|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179678|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179679|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179680|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179681|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179682|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179683|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179684|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179685|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179686|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179687|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179688|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179689|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179690|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179691|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179692|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179693|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179694|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179695|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179696|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179697|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179698|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179699|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179700|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179701|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179702|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179703|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179704|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179705|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179706|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179707|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179708|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179709|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179710|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179711|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179712|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179713|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179714|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179715|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179716|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179717|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179718|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179719|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179720|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179721|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179722|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179723|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179724|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179725|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179726|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179727|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179728|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179729|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179730|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179731|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179732|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179733|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179734|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179735|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179736|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179737|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179738|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
179739|NCT01258738|E2|Reported Event|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
179740|NCT01258738|E1|Reported Event|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
179741|NCT01258660|B3|Baseline|Total|Total of all reporting groups
179742|NCT01258660|B2|Baseline|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179743|NCT01258660|B1|Baseline|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179744|NCT01258660|P2|Participant Flow|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179800|NCT01257204|B2|Baseline|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179856|NCT01258387|P7|Participant Flow|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179745|NCT01258660|P1|Participant Flow|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179746|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179747|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179748|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179749|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179750|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179751|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179752|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179753|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179754|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179755|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179756|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179757|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179852|NCT01258387|B4|Baseline|GGF2 Third Escalated Dose|Third dosing: patients in cohort randomized to GGF2
179758|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179759|NCT01258660|E2|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179760|NCT01258660|E1|Reported Event|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
179761|NCT01258595|B3|Baseline|Total|Total of all reporting groups
179762|NCT01258595|B2|Baseline|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179763|NCT01258595|B1|Baseline|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179764|NCT01258595|P2|Participant Flow|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179765|NCT01258595|P1|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179766|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179767|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179768|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179769|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179770|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179771|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179772|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179773|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179774|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179775|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179776|NCT01258595|E2|Reported Event|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
179777|NCT01258595|E1|Reported Event|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
179778|NCT01258582|B3|Baseline|Total|Total of all reporting groups
179779|NCT01258582|B2|Baseline|Oral Fluid|Oral fluid rapid HIV testing
179780|NCT01258582|B1|Baseline|Fingerstick|Fingerstick rapid HIV testing
179781|NCT01258582|P2|Participant Flow|Oral Fluid|Oral fluid rapid HIV testing
179782|NCT01258582|P1|Participant Flow|Fingerstick|Fingerstick rapid HIV testing
179783|NCT01258582|O2|Outcome|Oral HIV Testing|oral fluid rapid HIV testing
179784|NCT01258582|O1|Outcome|Fingerstick HIV Testing|whole-blood fingerstick rapid HIV testing
179785|NCT01258582|E2|Reported Event|Oral Fluid|Oral fluid rapid HIV testing
179786|NCT01258582|E1|Reported Event|Fingerstick|Fingerstick rapid HIV testing
179787|NCT01258504|B1|Baseline|Bosentan|bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
179788|NCT01258504|P1|Participant Flow|Bosentan|bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
179789|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
179790|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
179791|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan125 mg p.o. day 1 single dose
179792|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
179793|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
179794|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
179795|NCT01258504|E3|Reported Event|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
179796|NCT01258504|E2|Reported Event|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
179797|NCT01258504|E1|Reported Event|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
179798|NCT01257204|B4|Baseline|Total|Total of all reporting groups
179799|NCT01257204|B3|Baseline|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179801|NCT01257204|B1|Baseline|Dacalatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179802|NCT01257204|P3|Participant Flow|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
179803|NCT01257204|P2|Participant Flow|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
179804|NCT01257204|P1|Participant Flow|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα­2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
179805|NCT01257204|O3|Outcome|Placebo: Follow-up|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
179806|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
179807|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
179808|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179809|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179810|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179811|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179812|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179813|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179814|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179815|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179816|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179817|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179818|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179819|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179820|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179821|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179822|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179823|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179824|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179825|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179826|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179827|NCT01257204|O2|Outcome|Dacalatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179828|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179829|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179830|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179831|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179832|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179833|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179834|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
179835|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179836|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179837|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179838|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
179839|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
179840|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
179841|NCT01257204|E6|Reported Event|Placebo: Follow-up|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
179842|NCT01257204|E5|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
179843|NCT01257204|E4|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
179844|NCT01257204|E3|Reported Event|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
179845|NCT01257204|E2|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
179846|NCT01257204|E1|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
179847|NCT01258387|B9|Baseline|Total|Total of all reporting groups
179848|NCT01258387|B8|Baseline|GGF2 Seventh Escalataed Dose|Seventh dosing: patients in cohort randomized to GGF2
179849|NCT01258387|B7|Baseline|GGF2 Sixth Escalated Dose|Sixth dosing: patients in cohort randomized to GGF2.
179850|NCT01258387|B6|Baseline|GGF2 Fifth Escalated Dose|Fifth dosing: patients in cohort randomized to GGF2
179851|NCT01258387|B5|Baseline|GGF2 Fourth Escalated Dose|Fourth dosing: patients in cohort randomized to GGF2
179857|NCT01258387|P6|Participant Flow|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
179858|NCT01258387|P5|Participant Flow|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179859|NCT01258387|P4|Participant Flow|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179860|NCT01258387|P3|Participant Flow|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179861|NCT01258387|P2|Participant Flow|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179862|NCT01258387|P1|Participant Flow|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
179863|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
179864|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
179865|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
179866|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
179867|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
179868|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
179869|NCT01258387|O2|Outcome|GGF2 First Dose|
179870|NCT01258387|O1|Outcome|Placebo|
179871|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
179872|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
179873|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
179874|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
179875|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
179876|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
179877|NCT01258387|O2|Outcome|GGF2 First Dose|
179878|NCT01258387|O1|Outcome|Placebo|
179879|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
179880|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
179881|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
179882|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
179883|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
179884|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
179885|NCT01258387|O2|Outcome|GGF2 First Dose|
179886|NCT01258387|O1|Outcome|Placebo|
179887|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
179888|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
179889|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
179890|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
179891|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
179892|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
179893|NCT01258387|O2|Outcome|GGF2 First Dose|
179894|NCT01258387|O1|Outcome|Placebo|
179895|NCT01258387|E8|Reported Event|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179896|NCT01258387|E7|Reported Event|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
179897|NCT01258387|E6|Reported Event|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179898|NCT01258387|E5|Reported Event|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179899|NCT01258387|E4|Reported Event|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179900|NCT01258387|E3|Reported Event|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179901|NCT01258387|E2|Reported Event|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
179902|NCT01258387|E1|Reported Event|Placebo|
179903|NCT01258153|B4|Baseline|Total|Total of all reporting groups
179904|NCT01258153|B3|Baseline|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179905|NCT01258153|B2|Baseline|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179906|NCT01258153|B1|Baseline|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179907|NCT01258153|P3|Participant Flow|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179908|NCT01258153|P2|Participant Flow|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
179909|NCT01258153|P1|Participant Flow|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
179910|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179911|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
179912|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
179913|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179914|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179915|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179916|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179917|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179918|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179919|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179920|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179921|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179922|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179923|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179924|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179925|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179926|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179927|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179928|NCT01258153|E3|Reported Event|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
179929|NCT01258153|E2|Reported Event|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179930|NCT01258153|E1|Reported Event|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
179931|NCT01258101|B5|Baseline|Total|Total of all reporting groups
179932|NCT01258101|B4|Baseline|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179933|NCT01258101|B3|Baseline|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179934|NCT01258101|B2|Baseline|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179935|NCT01258101|B1|Baseline|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179936|NCT01258101|P4|Participant Flow|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179937|NCT01258101|P3|Participant Flow|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179938|NCT01258101|P2|Participant Flow|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179939|NCT01258101|P1|Participant Flow|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
179940|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179941|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179942|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179943|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179944|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179945|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179946|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179947|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179948|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179949|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179950|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179951|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179952|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179953|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
183993|NCT01244516|P2|Participant Flow|Lotrafilcon B|lotrafilcon B, base curve 8.60
179954|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179955|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179956|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179957|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179958|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179959|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179960|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179961|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179962|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179963|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179964|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179965|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179966|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179967|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179968|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179969|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179970|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179971|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179972|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179973|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179974|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179975|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179976|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179977|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179978|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179979|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179980|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179981|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179982|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179983|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179984|NCT01258101|E4|Reported Event|Ribavirin 400 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
204849|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
179985|NCT01258101|E3|Reported Event|Ribavirin 800 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
179986|NCT01258101|E2|Reported Event|Ribavirin 400 mg/24W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
179987|NCT01258101|E1|Reported Event|Ribavirin 800 mg/24W|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
179988|NCT01258049|B3|Baseline|Total|Total of all reporting groups
179989|NCT01258049|B2|Baseline|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable
179990|NCT01258049|B1|Baseline|ArTiMist|"Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h.~Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable."
179991|NCT01258049|P2|Participant Flow|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable.
179992|NCT01258049|P1|Participant Flow|ArTiMist|Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h. Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable.
179993|NCT01258049|O2|Outcome|Quinine|
179994|NCT01258049|O1|Outcome|ArTiMist|
179995|NCT01258049|O2|Outcome|Quinine|
179996|NCT01258049|O1|Outcome|ArTiMist|
179997|NCT01258049|O2|Outcome|Quinine|
179998|NCT01258049|O1|Outcome|ArTiMist|
179999|NCT01258049|O2|Outcome|Quinine|
180000|NCT01258049|O1|Outcome|ArTiMist|
180001|NCT01258049|O2|Outcome|Quinine|
180002|NCT01258049|O1|Outcome|ArTiMist|
180003|NCT01258049|O2|Outcome|Quinine|
180004|NCT01258049|O1|Outcome|ArTiMist|
180005|NCT01258049|O2|Outcome|Quinine|
180006|NCT01258049|O1|Outcome|ArTiMist|
180007|NCT01258049|O2|Outcome|Quinine|
180008|NCT01258049|O1|Outcome|ArTiMist|
180009|NCT01258049|O2|Outcome|Quinine|
180010|NCT01258049|O1|Outcome|ArTiMist|
180011|NCT01258049|O2|Outcome|Quinine|
180012|NCT01258049|O1|Outcome|ArTiMist|
180013|NCT01258049|O2|Outcome|Quinine|
180014|NCT01258049|O1|Outcome|ArTiMist|
180015|NCT01258049|O2|Outcome|Quinine|
180016|NCT01258049|O1|Outcome|ArTiMist|
180017|NCT01258049|O2|Outcome|Quinine|
180018|NCT01258049|O1|Outcome|ArTiMist|
180019|NCT01258049|O2|Outcome|Quinine|
180020|NCT01258049|O1|Outcome|ArTiMist|
180021|NCT01258049|O2|Outcome|Quinine|
180022|NCT01258049|O1|Outcome|ArTiMist|
180023|NCT01258049|O2|Outcome|Quinine|
180024|NCT01258049|O1|Outcome|ArTiMist|
180025|NCT01258049|E2|Reported Event|Quinine|
180026|NCT01258049|E1|Reported Event|ArTiMist|
180027|NCT01256983|B3|Baseline|Total|Total of all reporting groups
180028|NCT01256983|B2|Baseline|No Intervention|10000 Lux after day 63
180029|NCT01256983|B1|Baseline|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
180030|NCT01256983|P2|Participant Flow|No Intervention|10000 Lux after day 63
180031|NCT01256983|P1|Participant Flow|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
180032|NCT01256983|O2|Outcome|No Intervention|10000 Lux after day 63
180033|NCT01256983|O1|Outcome|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
180034|NCT01256983|E2|Reported Event|Wait-list Intervention|Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
180035|NCT01256983|E1|Reported Event|Bright Light Therapy|Bright Light Therapy with 10000 lux beginning at day 21 until day 42
180036|NCT01256944|B3|Baseline|Total|Total of all reporting groups
180037|NCT01256944|B2|Baseline|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180038|NCT01256944|B1|Baseline|Control|The normal women
180039|NCT01256944|P2|Participant Flow|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
180040|NCT01256944|P1|Participant Flow|Control|The normal women
180041|NCT01256944|O4|Outcome|Nonb-obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
180208|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180042|NCT01256944|O3|Outcome|Non-obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180043|NCT01256944|O2|Outcome|Obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
180044|NCT01256944|O1|Outcome|Obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180045|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180046|NCT01256944|O1|Outcome|Control|The normal women
180047|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180048|NCT01256944|O1|Outcome|Control|The normal women
180049|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180050|NCT01256944|O1|Outcome|Control|The normal women
180051|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180052|NCT01256944|O1|Outcome|Control|The normal women
180053|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180054|NCT01256944|O1|Outcome|Control|The normal women
180055|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180056|NCT01256944|O1|Outcome|Control|The normal women
180057|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180058|NCT01256944|O1|Outcome|Control|The normal women
180059|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180060|NCT01256944|O1|Outcome|Control|The normal women
180061|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180062|NCT01256944|O1|Outcome|Control|The normal women
180063|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
180064|NCT01256944|O1|Outcome|Control|The normal women
180065|NCT01256944|E2|Reported Event|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
180066|NCT01256944|E1|Reported Event|Control|The normal women
180067|NCT01256918|B1|Baseline|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
180068|NCT01256918|P1|Participant Flow|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
180069|NCT01256918|O2|Outcome|Phacodepth|depth of penetration of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
180070|NCT01256918|O1|Outcome|Lens Thickness|lens thickness as measured using an A scan biometer
180071|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration (in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
180209|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180072|NCT01256918|O1|Outcome|Nuclear Opalescence|nuclear grading as per LOCS III criteria for cataract.nuclear opalescence is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
180073|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
180074|NCT01256918|O1|Outcome|Nuclear Colour|nuclear grading as per LOCS III criteria for cataract shall be done on a decimal scale from 0.1 to 6.9 nuclear colour is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
180075|NCT01256918|O1|Outcome|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop during the phacoemulsification procedure.
180076|NCT01256918|O1|Outcome|Phacodepth|A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .
180077|NCT01256918|E1|Reported Event|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
180078|NCT01255137|B1|Baseline|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
180079|NCT01255137|P1|Participant Flow|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
180080|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
180081|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
180082|NCT01255137|E1|Reported Event|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
180083|NCT01257880|B3|Baseline|Total|Total of all reporting groups
180084|NCT01257880|B2|Baseline|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
180085|NCT01257880|B1|Baseline|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
180086|NCT01257880|P2|Participant Flow|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
180087|NCT01257880|P1|Participant Flow|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
180088|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
180089|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
180090|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
180091|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
180092|NCT01257880|E2|Reported Event|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
180093|NCT01257880|E1|Reported Event|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
180094|NCT01257750|B1|Baseline|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
180095|NCT01257750|P1|Participant Flow|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
180096|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
180097|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
180098|NCT01257750|E1|Reported Event|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
180099|NCT01257581|B4|Baseline|Total|Total of all reporting groups
180100|NCT01257581|B3|Baseline|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180101|NCT01257581|B2|Baseline|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180102|NCT01257581|B1|Baseline|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180103|NCT01257581|P3|Participant Flow|Tamoxifen 80mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
180257|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180104|NCT01257581|P2|Participant Flow|Tamoxifen 40mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
180105|NCT01257581|P1|Participant Flow|Creatine 30gm|"Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.~creatine: creatine monohydrate powder"
180106|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180107|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180108|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180109|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180110|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180111|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180112|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180113|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180114|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180115|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180116|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180117|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180118|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180119|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180120|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180121|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180122|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180123|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180124|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180125|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180126|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180127|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180128|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180129|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
204850|NCT01181011|O2|Outcome|Telmisartan 80mg|
180130|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180131|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180132|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180133|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180134|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180135|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180136|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180137|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180138|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180139|NCT01257581|E3|Reported Event|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180140|NCT01257581|E2|Reported Event|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
180141|NCT01257581|E1|Reported Event|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
180142|NCT01257542|B3|Baseline|Total|Total of all reporting groups
180143|NCT01257542|B2|Baseline|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180144|NCT01257542|B1|Baseline|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180145|NCT01257542|P2|Participant Flow|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180146|NCT01257542|P1|Participant Flow|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180147|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180148|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180149|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180150|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180151|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180152|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180153|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180154|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180155|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180156|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180157|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180158|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180159|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180160|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180161|NCT01257542|E2|Reported Event|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
180162|NCT01257542|E1|Reported Event|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
180163|NCT01257503|B3|Baseline|Total|Total of all reporting groups
180164|NCT01257503|B2|Baseline|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180165|NCT01257503|B1|Baseline|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180166|NCT01257503|P2|Participant Flow|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180167|NCT01257503|P1|Participant Flow|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180168|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180169|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180170|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180171|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180172|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180173|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180174|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180175|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180176|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180177|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180178|NCT01257503|E2|Reported Event|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
180179|NCT01257503|E1|Reported Event|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
180180|NCT01257438|B3|Baseline|Total|Total of all reporting groups
180181|NCT01257438|B2|Baseline|PTA Only|PTA only: Treatment of in-stent restenosis
180182|NCT01257438|B1|Baseline|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180183|NCT01257438|P2|Participant Flow|PTA Only|PTA only: Treatment of in-stent restenosis
180184|NCT01257438|P1|Participant Flow|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180185|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
180186|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180187|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
180188|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180189|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
180190|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180191|NCT01257438|E2|Reported Event|PTA Only|PTA only: Treatment of in-stent restenosis
180192|NCT01257438|E1|Reported Event|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
180193|NCT01257425|B3|Baseline|Total|Total of all reporting groups
180194|NCT01257425|B2|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180195|NCT01257425|B1|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180196|NCT01257425|P2|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180197|NCT01257425|P1|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180198|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180199|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180200|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180201|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180202|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180203|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180204|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180205|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180206|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180207|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
183994|NCT01244516|P1|Participant Flow|Galyfilcon A|galyfilcon A base curve 8.30
180210|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180211|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180212|NCT01257425|E2|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
180213|NCT01257425|E1|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
180214|NCT01257230|B4|Baseline|Total|Total of all reporting groups
180215|NCT01257230|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180216|NCT01257230|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180217|NCT01257230|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180218|NCT01257230|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.
180219|NCT01257230|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180220|NCT01257230|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180221|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180222|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180223|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180224|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180225|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180226|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180227|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180228|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180229|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180230|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180231|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180232|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180233|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180234|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180235|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180236|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180237|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180238|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180239|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180240|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180241|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180242|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180243|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180244|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180245|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180246|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180247|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180248|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180249|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180250|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180251|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180252|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler
180253|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180254|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180255|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180256|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180258|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180259|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180260|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180261|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180262|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180263|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180264|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180265|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180266|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180267|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180268|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180269|NCT01257230|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180270|NCT01257230|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
180271|NCT01257230|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
180272|NCT01256658|B3|Baseline|Total|Total of all reporting groups
180273|NCT01256658|B2|Baseline|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180274|NCT01256658|B1|Baseline|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180275|NCT01256658|P2|Participant Flow|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180276|NCT01256658|P1|Participant Flow|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180277|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180278|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180279|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180280|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180281|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180282|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180283|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180284|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180285|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180286|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180287|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
180288|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180289|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
180290|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180291|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180292|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180293|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180294|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180295|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180296|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180297|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180298|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180299|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180300|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180301|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180302|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180303|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180304|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180305|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180306|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180307|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180308|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180309|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180310|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180311|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180312|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180313|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180314|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180315|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180316|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180317|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180318|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180319|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
180320|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180321|NCT01256658|E4|Reported Event|Control - Period 2- Follow-up Only|Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
180322|NCT01256658|E3|Reported Event|Intervention - Period 2 - Follow-up Only|Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
180323|NCT01256658|E2|Reported Event|Control - Period 1|Participants received COA566 treatment for symptomatic malaria episodes only.
180324|NCT01256658|E1|Reported Event|Intervention - Period 1|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
180325|NCT01256567|B1|Baseline|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180326|NCT01256567|P1|Participant Flow|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180327|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180328|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel : Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab : Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180329|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180330|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180331|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180332|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180333|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180334|NCT01256567|E1|Reported Event|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
180335|NCT01256502|B1|Baseline|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
180336|NCT01256502|P1|Participant Flow|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
180337|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
180338|NCT01256502|O5|Outcome|Very Easy to Use|
180339|NCT01256502|O4|Outcome|Easy to Use|
180340|NCT01256502|O3|Outcome|Neither Difficult Nor Easy to Use|
180341|NCT01256502|O2|Outcome|Difficult to Use|
180342|NCT01256502|O1|Outcome|Very Difficult to Use|
180343|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
183995|NCT01244516|O2|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
180344|NCT01256502|E1|Reported Event|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
180345|NCT01256476|B3|Baseline|Total|Total of all reporting groups
180346|NCT01256476|B2|Baseline|Pravastatin 40 mg Once a Day (QD)|
180347|NCT01256476|B1|Baseline|Pitavastatin 4 mg Once a Day (QD)|
180348|NCT01256476|P2|Participant Flow|Pravastatin 40 mg Once a Day (QD)|
180349|NCT01256476|P1|Participant Flow|Pitavastatin 4 mg Once a Day (QD)|
180350|NCT01256476|O2|Outcome|Pravastatin 40 mg Once Daily (QD)|
180351|NCT01256476|O1|Outcome|Pitavastatin 4 mg Once Daily (QD)|
180352|NCT01256476|E2|Reported Event|Pravastatin 40 mg Once a Day (QD)|
180353|NCT01256476|E1|Reported Event|Pitavastatin 4 mg Once a Day (QD)|
180354|NCT01256450|B3|Baseline|Total|Total of all reporting groups
180355|NCT01256450|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180356|NCT01256450|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180357|NCT01256450|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180358|NCT01256450|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180359|NCT01256450|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
180360|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180361|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180362|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180363|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180364|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180365|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180366|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180367|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180368|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180369|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180370|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180371|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180372|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180373|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180374|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180375|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180376|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180377|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180378|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180379|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
180380|NCT01256450|E3|Reported Event|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
180381|NCT01256450|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
180382|NCT01256450|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
180383|NCT01256424|B5|Baseline|Total|Total of all reporting groups
180384|NCT01256424|B4|Baseline|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
180385|NCT01256424|B3|Baseline|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180386|NCT01256424|B2|Baseline|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
183996|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
180387|NCT01256424|B1|Baseline|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180388|NCT01256424|P4|Participant Flow|Placebo Ointment Without Illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
180389|NCT01256424|P3|Participant Flow|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180390|NCT01256424|P2|Participant Flow|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180391|NCT01256424|P1|Participant Flow|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180392|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
180393|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180394|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180395|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180396|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
180397|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180398|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180399|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180400|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
180401|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180402|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180403|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180404|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
180405|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180406|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180407|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180408|NCT01256424|E4|Reported Event|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
180409|NCT01256424|E3|Reported Event|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
180410|NCT01256424|E2|Reported Event|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
180411|NCT01256424|E1|Reported Event|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
180412|NCT01256411|B5|Baseline|Total|Total of all reporting groups
180413|NCT01256411|B4|Baseline|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180414|NCT01256411|B3|Baseline|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
180415|NCT01256411|B2|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180416|NCT01256411|B1|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180417|NCT01256411|P6|Participant Flow|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
180418|NCT01256411|P5|Participant Flow|LCZ696 Monotherapy|Participants received LCZ696 only.
180419|NCT01256411|P4|Participant Flow|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180420|NCT01256411|P3|Participant Flow|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
180421|NCT01256411|P2|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180422|NCT01256411|P1|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180423|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
180424|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
180425|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180426|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
180427|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180428|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180429|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
180430|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
204851|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
180431|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180432|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
180433|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180434|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180435|NCT01256411|O5|Outcome|LCZ696 100 mg|Participants were down-titrated to 100 mg.
180436|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180437|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
180438|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180439|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180440|NCT01256411|E5|Reported Event|LCZ696 400 mg/Aml/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180441|NCT01256411|E4|Reported Event|LCZ696 400 mg/Aml|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
180442|NCT01256411|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
180443|NCT01256411|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
180444|NCT01256411|E1|Reported Event|LCZ696 100 mg|Participants were down-titrated to 100 mg.
180445|NCT01256385|B3|Baseline|Total|Total of all reporting groups
180446|NCT01256385|B2|Baseline|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180447|NCT01256385|B1|Baseline|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180448|NCT01256385|P2|Participant Flow|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180449|NCT01256385|P1|Participant Flow|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180450|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180451|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180452|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180453|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180454|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180455|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180456|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180457|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180458|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180459|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180460|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180461|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180462|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180463|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180464|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180465|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180466|NCT01256385|E2|Reported Event|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
180467|NCT01256385|E1|Reported Event|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
180468|NCT01256294|B1|Baseline|All Participants|"Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).~Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus."
180469|NCT01256294|P2|Participant Flow|Sequence 2 - Generic Tacrolimus / Branded Tacrolimus|In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).
180470|NCT01256294|P1|Participant Flow|Sequence 1 - Branded Tacrolimus / Generic Tacrolimus|In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
180471|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180472|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180473|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180474|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180475|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180476|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180477|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180478|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180479|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180480|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180481|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180482|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180483|NCT01256294|E2|Reported Event|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
180484|NCT01256294|E1|Reported Event|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
180485|NCT01256281|B1|Baseline|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
180486|NCT01256281|P1|Participant Flow|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
180487|NCT01256281|O1|Outcome|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
180488|NCT01256281|E1|Reported Event|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
180489|NCT01256190|B3|Baseline|Total|Total of all reporting groups
180490|NCT01256190|B2|Baseline|Gelatin Sponge|approved device for surgical bleeding
180491|NCT01256190|B1|Baseline|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180492|NCT01256190|P2|Participant Flow|Gelatin Sponge|approved device for surgical bleeding
180493|NCT01256190|P1|Participant Flow|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180494|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
180495|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180496|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
180497|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180498|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
180499|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180500|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
180501|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180502|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
180503|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180504|NCT01256190|E2|Reported Event|Gelatin Sponge|approved device for surgical bleeding
180505|NCT01256190|E1|Reported Event|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
180506|NCT01256177|B3|Baseline|Total|Total of all reporting groups
183997|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
180507|NCT01256177|B2|Baseline|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180508|NCT01256177|B1|Baseline|Placebo|Placebo matching Quetiapine XR.
180509|NCT01256177|P2|Participant Flow|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180510|NCT01256177|P1|Participant Flow|Placebo|Placebo matching Quetiapine XR.
180511|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180512|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180513|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180514|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180515|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180516|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180517|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180518|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180519|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180520|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180521|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180522|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180523|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180524|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180525|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180526|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180527|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
180528|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
180529|NCT01256177|E2|Reported Event|QUETIAPINE XR|
180530|NCT01256177|E1|Reported Event|PLACEBO|
180531|NCT01256164|B3|Baseline|Total|Total of all reporting groups
180532|NCT01256164|B2|Baseline|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180533|NCT01256164|B1|Baseline|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180534|NCT01256164|P2|Participant Flow|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180535|NCT01256164|P1|Participant Flow|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180536|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180537|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180538|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180539|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180540|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180541|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180542|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180543|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180544|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
181089|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
180545|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180546|NCT01256164|E2|Reported Event|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
180547|NCT01256164|E1|Reported Event|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
180548|NCT01256086|B5|Baseline|Total|Total of all reporting groups
180549|NCT01256086|B4|Baseline|A2N2N1A1|Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
180550|NCT01256086|B3|Baseline|N2A1A2N1|Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
180551|NCT01256086|B2|Baseline|A1N1N2A2|Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
180552|NCT01256086|B1|Baseline|N1A2A1N2|Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
180553|NCT01256086|P4|Participant Flow|A2N2N1A1|Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
180554|NCT01256086|P3|Participant Flow|N2A1A2N1|Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
180555|NCT01256086|P2|Participant Flow|A1N1N2A2|Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
180556|NCT01256086|P1|Participant Flow|N1A2A1N2|Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
180557|NCT01256086|O4|Outcome|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
180558|NCT01256086|O3|Outcome|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
180559|NCT01256086|O2|Outcome|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
180560|NCT01256086|O1|Outcome|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
180561|NCT01256086|E4|Reported Event|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
180562|NCT01256086|E3|Reported Event|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
180563|NCT01256086|E2|Reported Event|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
180564|NCT01256086|E1|Reported Event|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
180565|NCT01256060|B1|Baseline|Intanasal Oxytocin|"A modified dose finding method was used to determine safety among four dose levels. Half the dose (0.2 IU/kg /dose) was the minimum dose and two intermediate doses were also evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations were done in groups of three patients.~Three patients were studied at the first dose level~If none of these patients experienced dose limiting toxicity, the dose was escalated.~If one patient experienced dose limiting toxicity, up to three more patients were accrued at the same level. (a) If none of these patients experienced dose limiting toxicity, the dose was escalated. (b) If one or more experienced dose-limiting toxicity, entry at that dose level would be stopped, the maximum tolerated dose exceeded, and dose escalation would be stopped. Up to three more patients would be treated at the next lower dose. If zero out of three patients experience dose limiting toxicity, an additional three patients were to be treated at that dose."
180566|NCT01256060|P4|Participant Flow|0.4 IU / kg|
180567|NCT01256060|P3|Participant Flow|0.33 IU / kg|
180568|NCT01256060|P2|Participant Flow|0.26 IU / kg|
180569|NCT01256060|P1|Participant Flow|0.2 IU / kg|
180570|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
180571|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
180572|NCT01256060|O1|Outcome|Intanasal Oxytocin|Number of Participants Experiencing a Serious Adverse Event
180573|NCT01256060|O1|Outcome|Intanasal Oxytocin|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
180574|NCT01256060|E1|Reported Event|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size.
180575|NCT01256034|B3|Baseline|Total|Total of all reporting groups
180576|NCT01256034|B2|Baseline|Group B|ordinary diet
180577|NCT01256034|B1|Baseline|Group A|preoperative immunonutrition
180578|NCT01256034|P2|Participant Flow|Group B|ordinary diet
180579|NCT01256034|P1|Participant Flow|Group A|preoperative immunonutrition
180580|NCT01256034|O2|Outcome|Group B|ordinary diet
180581|NCT01256034|O1|Outcome|Group A|preoperative immunonutrition
180582|NCT01256034|E2|Reported Event|Group B|ordinary diet
180583|NCT01256034|E1|Reported Event|Group A|preoperative immunonutrition
180584|NCT01256008|B4|Baseline|Total|Total of all reporting groups
180585|NCT01256008|B3|Baseline|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180613|NCT01255904|P1|Participant Flow|Oral Placebo and Intransal Dexmedetomidine|Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
180586|NCT01256008|B2|Baseline|stage1 CBT|"The experimental group each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180587|NCT01256008|B1|Baseline|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180588|NCT01256008|P3|Participant Flow|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180589|NCT01256008|P2|Participant Flow|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180590|NCT01256008|P1|Participant Flow|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180591|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180592|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180593|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180594|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180595|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180596|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180597|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180614|NCT01255904|O2|Outcome|Oral Chloral Hydrate and Intranasal Placebo|
180615|NCT01255904|O1|Outcome|Oral Placebo and Intransal Dexmedetomidine|
180616|NCT01255904|E2|Reported Event|Oral Chloral Hydrate and Intranasal Placebo|
180617|NCT01255904|E1|Reported Event|Oral Placebo and Intransal Dexmedetomidine|
180618|NCT01255787|B5|Baseline|Total|Total of all reporting groups
180598|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180599|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180600|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180601|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180602|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180603|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180604|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180605|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180606|NCT01256008|E3|Reported Event|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
180607|NCT01256008|E2|Reported Event|stage1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
180608|NCT01256008|E1|Reported Event|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
180609|NCT01255904|B3|Baseline|Total|Total of all reporting groups
180610|NCT01255904|B2|Baseline|Oral Chloral Hydrate and Intranasal Placebo|
180611|NCT01255904|B1|Baseline|Oral Placebo and Intransal Dexmedetomidine|
180612|NCT01255904|P2|Participant Flow|Oral Chloral Hydrate and Intranasal Placebo|50 mg/kg oral chloral hydrate followed by intranasal placebo.
180792|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
180793|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
180619|NCT01255787|B4|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180620|NCT01255787|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180621|NCT01255787|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180622|NCT01255787|B1|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180623|NCT01255787|P4|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180624|NCT01255787|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180625|NCT01255787|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180626|NCT01255787|P1|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180627|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180628|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180629|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180630|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180631|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180632|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180633|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180634|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180635|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180636|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180637|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180638|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180639|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180640|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180641|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180642|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180643|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180644|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180645|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180646|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180647|NCT01255787|E4|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
180648|NCT01255787|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180649|NCT01255787|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
180650|NCT01255787|E1|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
180651|NCT01255761|B3|Baseline|Total|Total of all reporting groups
180652|NCT01255761|B2|Baseline|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180653|NCT01255761|B1|Baseline|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180794|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
180654|NCT01255761|P2|Participant Flow|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180655|NCT01255761|P1|Participant Flow|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180656|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180657|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180658|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180659|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180660|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180661|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180662|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180663|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180664|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180665|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180666|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180667|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180668|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180669|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180670|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180671|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180672|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180673|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180674|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180675|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180676|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180677|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180678|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180679|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180680|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180681|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180682|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180683|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180684|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180685|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180686|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180687|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180688|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180689|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180690|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180691|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180692|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180693|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180694|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180695|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180696|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180697|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180698|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180699|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180700|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180701|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180702|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180703|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180704|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180705|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180706|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180707|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180708|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180709|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180710|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180711|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180712|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180713|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180714|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180715|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180716|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180717|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180718|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180719|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180720|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180721|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180722|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180723|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180724|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180725|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180726|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180727|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180728|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180729|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180730|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180731|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180732|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180733|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180734|NCT01255761|E2|Reported Event|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
180735|NCT01255761|E1|Reported Event|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
180736|NCT01255722|B4|Baseline|Total|Total of all reporting groups
180737|NCT01255722|B3|Baseline|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180738|NCT01255722|B2|Baseline|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180739|NCT01255722|B1|Baseline|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180740|NCT01255722|P3|Participant Flow|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180741|NCT01255722|P2|Participant Flow|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180742|NCT01255722|P1|Participant Flow|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180743|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180744|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180745|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180746|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180747|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180748|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180749|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180750|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180751|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180752|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180753|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180754|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180755|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180756|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before coronary CT angiography
180757|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180758|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
180759|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
180760|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
180761|NCT01255722|E3|Reported Event|Iomeprol|"Patients were IV injected with a single dose of iomeprol before a coronary CT angiography~iomeprol: Single IV injection"
180762|NCT01255722|E2|Reported Event|Iopromide|"Patients were IV injected with a single dose of iopromide before a coronary CT angiography~iopromide: Single IV injection"
180763|NCT01255722|E1|Reported Event|Iobitridol|"Patients were IV injected with a single dose of iobitridol before a coronary CT angiography~iobitridol: single IV injection"
180764|NCT01255631|B3|Baseline|Total|Total of all reporting groups
180765|NCT01255631|B2|Baseline|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180766|NCT01255631|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180795|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
180796|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
180797|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
180767|NCT01255631|P2|Participant Flow|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180768|NCT01255631|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180769|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180770|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180771|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180772|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180773|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180774|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180775|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180776|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180777|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180778|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180779|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180780|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180781|NCT01255631|E2|Reported Event|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
180782|NCT01255631|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
180783|NCT01255592|B3|Baseline|Total|Total of all reporting groups
180784|NCT01255592|B2|Baseline|Placebo|Placebo bd
180785|NCT01255592|B1|Baseline|AZD5069|AZD5069 80 mg bd
180786|NCT01255592|P2|Participant Flow|Placebo|Placebo for AZD5069, bd
180787|NCT01255592|P1|Participant Flow|AZD5069|AZD5069 80 mg bd
180788|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
180789|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
180790|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
180791|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
180842|NCT01255449|B1|Baseline|Albuterol|All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
180843|NCT01255449|P1|Participant Flow|Albuterol|On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
180844|NCT01255449|O1|Outcome|Post-HSCT Changes in Lung Tissue Density|In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
180845|NCT01255449|O1|Outcome|Airway Distensibility With Lung Inflation After HSCT|Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
180846|NCT01255449|E1|Reported Event|Albuterol|All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
180847|NCT01255436|B3|Baseline|Total|Total of all reporting groups
180848|NCT01255436|B2|Baseline|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180849|NCT01255436|B1|Baseline|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180850|NCT01255436|P2|Participant Flow|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180851|NCT01255436|P1|Participant Flow|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180852|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180853|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180854|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180855|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180856|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180857|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180858|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180859|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180860|NCT01255436|E2|Reported Event|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
180861|NCT01255436|E1|Reported Event|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
180862|NCT01255423|B3|Baseline|Total|Total of all reporting groups
180863|NCT01255423|B2|Baseline|Placebo|
180864|NCT01255423|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
180865|NCT01255423|P2|Participant Flow|Placebo|
180866|NCT01255423|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
180867|NCT01255423|O2|Outcome|Placebo|
180868|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
180869|NCT01255423|O2|Outcome|Placebo|
180870|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
180871|NCT01255423|O2|Outcome|Placebo|
180872|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
180873|NCT01255423|O2|Outcome|Placebo|
180874|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
180875|NCT01255423|O2|Outcome|Placebo|
180876|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
180877|NCT01255423|E2|Reported Event|Placebo|
180878|NCT01255423|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
180879|NCT01255306|B3|Baseline|Total|Total of all reporting groups
180880|NCT01255306|B2|Baseline|RAISED IOP|Patients with raised IOP
180881|NCT01255306|B1|Baseline|NO IOP|Patients without raised IOP
180882|NCT01255306|P2|Participant Flow|RAISED IOP|Patients with raised IOP
180883|NCT01255306|P1|Participant Flow|NO IOP|Patients without raised IOP
180884|NCT01255306|O3|Outcome|CONTROL|Fellow eye of each patient
180885|NCT01255306|O2|Outcome|RAISED IOP|Patients with raised IOP
180886|NCT01255306|O1|Outcome|NO IOP|Patients without raised IOP
180887|NCT01255306|O2|Outcome|CONTROL EYES|Fellow eye of each patient
180888|NCT01255306|O1|Outcome|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
180889|NCT01255306|E2|Reported Event|CONTROL EYES|Fellow eye of each patient
180890|NCT01255306|E1|Reported Event|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
180891|NCT01254890|B3|Baseline|Total|Total of all reporting groups
180892|NCT01254890|B2|Baseline|Phase II: Azacitidine + 400 Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
180893|NCT01254890|B1|Baseline|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
180894|NCT01254890|P2|Participant Flow|Phase II: Azacitidine + 400 mg Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
180895|NCT01254890|P1|Participant Flow|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
180896|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
180897|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
180898|NCT01254890|E2|Reported Event|Phase II: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
180944|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180899|NCT01254890|E1|Reported Event|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
180900|NCT01254851|B3|Baseline|Total|Total of all reporting groups
180901|NCT01254851|B2|Baseline|Usual Care|routine post-operative ambulation
180902|NCT01254851|B1|Baseline|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
180903|NCT01254851|P2|Participant Flow|Usual Care|routine post-operative ambulation
180904|NCT01254851|P1|Participant Flow|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
180905|NCT01254851|O2|Outcome|Usual Care|routine post-operative ambulation
180906|NCT01254851|O1|Outcome|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
180907|NCT01254851|E2|Reported Event|Usual Care|routine post-operative ambulation
180908|NCT01254851|E1|Reported Event|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
180909|NCT01254760|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
180910|NCT01254760|P2|Participant Flow|Commercial Multifocal / Investigational Multifocal|Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
180911|NCT01254760|P1|Participant Flow|Investigational Multifocal / Commercial Multifocal|Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
180912|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180913|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180914|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
180915|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180916|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180917|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180918|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180919|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180920|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180921|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
180922|NCT01254760|E2|Reported Event|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
180923|NCT01254760|E1|Reported Event|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
180924|NCT01254747|B5|Baseline|Total|Total of all reporting groups
180925|NCT01254747|B4|Baseline|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180926|NCT01254747|B3|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180927|NCT01254747|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180928|NCT01254747|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180929|NCT01254747|P4|Participant Flow|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180930|NCT01254747|P3|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180931|NCT01254747|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180932|NCT01254747|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180933|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180934|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180935|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180936|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180937|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180938|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180939|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180940|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180941|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180942|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180943|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
204852|NCT01181011|O2|Outcome|Telmisartan 80mg|
180945|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180946|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180947|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180948|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180949|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180950|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180951|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180952|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180953|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180954|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180955|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180956|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180957|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180958|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180959|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180960|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180961|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180962|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180963|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180964|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180965|NCT01254747|E4|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180966|NCT01254747|E3|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180967|NCT01254747|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180968|NCT01254747|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
180969|NCT01254721|B3|Baseline|Total|Total of all reporting groups
180970|NCT01254721|B2|Baseline|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
180971|NCT01254721|B1|Baseline|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
180972|NCT01254721|P2|Participant Flow|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
180973|NCT01254721|P1|Participant Flow|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
180974|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
180975|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
180976|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
180977|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
180978|NCT01254721|E2|Reported Event|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
180979|NCT01254721|E1|Reported Event|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
180980|NCT01254669|B3|Baseline|Total|Total of all reporting groups
180981|NCT01254669|B2|Baseline|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .
181003|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180982|NCT01254669|B1|Baseline|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
180983|NCT01254669|P2|Participant Flow|BNI Intervention|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status"
180984|NCT01254669|P1|Participant Flow|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No BNI counseling was provided."
180985|NCT01254669|O2|Outcome|Control Group|Did not receive any BNI intervention on the pre and post measure
180986|NCT01254669|O1|Outcome|BNI Post-educational Intervention Group|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)"
180987|NCT01254669|O2|Outcome|BNI/Intervention|Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
180988|NCT01254669|O1|Outcome|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
180989|NCT01254669|E2|Reported Event|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
180990|NCT01254669|E1|Reported Event|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
180991|NCT01254656|B4|Baseline|Total|Total of all reporting groups
180992|NCT01254656|B3|Baseline|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180993|NCT01254656|B2|Baseline|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180994|NCT01254656|B1|Baseline|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180995|NCT01254656|P3|Participant Flow|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180996|NCT01254656|P2|Participant Flow|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180997|NCT01254656|P1|Participant Flow|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180998|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
180999|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181000|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181001|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181002|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181004|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181005|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181006|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181007|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181008|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181009|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181010|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181011|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181012|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181013|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181014|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181015|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181016|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181017|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181018|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181019|NCT01254656|E3|Reported Event|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181020|NCT01254656|E2|Reported Event|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181021|NCT01254656|E1|Reported Event|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
181022|NCT01254643|B1|Baseline|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181023|NCT01254643|P1|Participant Flow|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181024|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181025|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181026|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181027|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181028|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181029|NCT01254643|E1|Reported Event|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
181030|NCT01254604|B3|Baseline|Total|Total of all reporting groups
181031|NCT01254604|B2|Baseline|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181032|NCT01254604|B1|Baseline|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181033|NCT01254604|P2|Participant Flow|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181034|NCT01254604|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181035|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181036|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181037|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181038|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181039|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181040|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181041|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181042|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181043|NCT01254604|E2|Reported Event|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
181044|NCT01254604|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
181045|NCT01254409|B5|Baseline|Total|Total of all reporting groups
181046|NCT01254409|B4|Baseline|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181047|NCT01254409|B3|Baseline|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181048|NCT01254409|B2|Baseline|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181049|NCT01254409|B1|Baseline|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181050|NCT01254409|P4|Participant Flow|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181051|NCT01254409|P3|Participant Flow|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181052|NCT01254409|P2|Participant Flow|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181053|NCT01254409|P1|Participant Flow|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181054|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181055|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181056|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181057|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181058|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181059|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181060|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181061|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181062|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181063|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181064|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181065|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181066|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181067|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181068|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181069|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181070|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181071|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181072|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181073|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181074|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181075|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181076|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181077|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181078|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181079|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181080|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181081|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181082|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181083|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181084|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181085|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181086|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181087|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181088|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
204853|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
181090|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181091|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181092|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181093|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181094|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181095|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181096|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181097|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181098|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181099|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181100|NCT01254409|E4|Reported Event|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181101|NCT01254409|E3|Reported Event|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181102|NCT01254409|E2|Reported Event|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181103|NCT01254409|E1|Reported Event|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
181104|NCT01254396|B1|Baseline|Entire Study Population|Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
181105|NCT01254396|P2|Participant Flow|Sildenafil Fed First, Then Sildenafil Fasted|Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
181106|NCT01254396|P1|Participant Flow|Sildenafil Fasted First, Then Sildenafil Fed|Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
181107|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181108|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181109|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181110|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181111|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181112|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181113|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181114|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181115|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181116|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181117|NCT01254396|E2|Reported Event|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
181118|NCT01254396|E1|Reported Event|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
181119|NCT01254344|B3|Baseline|Total|Total of all reporting groups
181120|NCT01254344|B2|Baseline|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
181121|NCT01254344|B1|Baseline|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
181122|NCT01254344|P2|Participant Flow|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
181123|NCT01254344|P1|Participant Flow|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
181124|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
181125|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
181126|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
181127|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
181128|NCT01254344|E2|Reported Event|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
181129|NCT01254344|E1|Reported Event|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
181130|NCT01254331|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181131|NCT01254331|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181132|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181133|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181134|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181135|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181136|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181137|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181138|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181139|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181140|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181141|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181142|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181143|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181144|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181145|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181146|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181228|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181147|NCT01254331|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
181148|NCT01254318|B1|Baseline|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
181149|NCT01254318|P1|Participant Flow|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
181150|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
181151|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
181152|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
181153|NCT01254318|E1|Reported Event|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
181154|NCT01254305|B4|Baseline|Total|Total of all reporting groups
181155|NCT01254305|B3|Baseline|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181156|NCT01254305|B2|Baseline|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
181157|NCT01254305|B1|Baseline|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
181158|NCT01254305|P3|Participant Flow|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181159|NCT01254305|P2|Participant Flow|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
181160|NCT01254305|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
181161|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181162|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.
181163|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
181164|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181165|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks
181166|NCT01254305|O1|Outcome|Placebo|Dose matched placebo capsules, oral administration for 8 weeks.
181167|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181168|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
181169|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
204854|NCT01181011|O2|Outcome|Telmisartan 80mg|
181170|NCT01254305|E3|Reported Event|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
181171|NCT01254305|E2|Reported Event|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
181172|NCT01254305|E1|Reported Event|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
181173|NCT01254292|B3|Baseline|Total|Total of all reporting groups
181174|NCT01254292|B2|Baseline|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181175|NCT01254292|B1|Baseline|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181176|NCT01254292|P2|Participant Flow|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181177|NCT01254292|P1|Participant Flow|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181178|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181179|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181180|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181181|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181182|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181183|NCT01254292|O1|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181184|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181185|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181186|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181187|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181188|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181189|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181190|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181191|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181192|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181193|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181194|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181195|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181196|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181197|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181198|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181199|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181200|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181201|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181202|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181203|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181204|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181205|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181206|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181207|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181208|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181209|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181210|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181211|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181212|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181213|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181214|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181215|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181216|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181217|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181218|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181219|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181220|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181221|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181222|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181223|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181224|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181225|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181226|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
181227|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181229|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
181230|NCT01254292|E2|Reported Event|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 micron ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles.
181231|NCT01254292|E1|Reported Event|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 micron LNG per day for 18 months with optional extension to 36 months.
181232|NCT01254214|B3|Baseline|Total|Total of all reporting groups
181233|NCT01254214|B2|Baseline|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181234|NCT01254214|B1|Baseline|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181235|NCT01254214|P2|Participant Flow|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181236|NCT01254214|P1|Participant Flow|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181237|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181238|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181239|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181240|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181241|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181242|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181243|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181270|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
181271|NCT01254045|O2|Outcome|Oxytocin 24IU/Placebo 24IU|24 international units of intranasal oxytocin and 24 international units of placebo
181272|NCT01254045|O1|Outcome|Placebo|placebo (48IU)
181313|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181244|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181245|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181246|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181247|NCT01254214|E2|Reported Event|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
181248|NCT01254214|E1|Reported Event|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
181249|NCT01254188|B1|Baseline|Nilotinib|Nilotinib 300 mg BID
181250|NCT01254188|P1|Participant Flow|Nilotinib|Nilotinib 300 mg BID
181251|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181252|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181253|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181254|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181255|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181256|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181257|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181258|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
181259|NCT01254188|E1|Reported Event|Nilotinib|Nilotinib 300 mg BID
181260|NCT01254045|B1|Baseline|All Study Participants|Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
181261|NCT01254045|P6|Participant Flow|Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181262|NCT01254045|P5|Participant Flow|Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181263|NCT01254045|P4|Participant Flow|Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181264|NCT01254045|P3|Participant Flow|Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181265|NCT01254045|P2|Participant Flow|Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181266|NCT01254045|P1|Participant Flow|Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
181267|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
181268|NCT01254045|O2|Outcome|24IU OT|24 international units of intranasal oxytocin and 24 IU of placebo
181269|NCT01254045|O1|Outcome|Placebo|placebo (48 IU)
181273|NCT01254045|E3|Reported Event|Intervention: Oxytocin 48IU|Three participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.
181274|NCT01254045|E2|Reported Event|Intervention: Oxytocin 24IU/Placebo 24IU|Three participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.
181275|NCT01254045|E1|Reported Event|Intervention: Placebo 48IU|Two participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.
181276|NCT01253980|B3|Baseline|Total|Total of all reporting groups
181277|NCT01253980|B2|Baseline|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
181278|NCT01253980|B1|Baseline|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
181279|NCT01253980|P2|Participant Flow|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
181280|NCT01253980|P1|Participant Flow|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
181281|NCT01253980|O2|Outcome|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
181282|NCT01253980|O1|Outcome|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
181283|NCT01253980|E2|Reported Event|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
181284|NCT01253980|E1|Reported Event|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
181285|NCT01253902|B4|Baseline|Total|Total of all reporting groups
181286|NCT01253902|B3|Baseline|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181287|NCT01253902|B2|Baseline|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181288|NCT01253902|B1|Baseline|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181289|NCT01253902|P3|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181290|NCT01253902|P2|Participant Flow|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181291|NCT01253902|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181292|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181293|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181294|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181295|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181296|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181297|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181298|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181299|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181300|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181301|NCT01253902|E3|Reported Event|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181302|NCT01253902|E2|Reported Event|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
181303|NCT01253902|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
181304|NCT01253824|B3|Baseline|Total|Total of all reporting groups
181305|NCT01253824|B2|Baseline|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181306|NCT01253824|B1|Baseline|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181307|NCT01253824|P2|Participant Flow|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181308|NCT01253824|P1|Participant Flow|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181309|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181310|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181311|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181312|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181415|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181314|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181315|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181316|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181317|NCT01253824|E2|Reported Event|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
181318|NCT01253824|E1|Reported Event|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
181319|NCT01253811|B1|Baseline|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181320|NCT01253811|P1|Participant Flow|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181321|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181322|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181323|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181324|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181325|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181326|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181327|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181328|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181348|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181349|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181329|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181330|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181331|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181332|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181333|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181334|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181335|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181336|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181337|NCT01253811|E1|Reported Event|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
181338|NCT01253577|B1|Baseline|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
181339|NCT01253577|P1|Participant Flow|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
181340|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
181341|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
181342|NCT01253577|O1|Outcome|All Subjects|
181343|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
181344|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
181345|NCT01253577|E1|Reported Event|All Patients|Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
181346|NCT01253564|B1|Baseline|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181347|NCT01253564|P1|Participant Flow|Vemurafenib|Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181414|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181350|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181351|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181352|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181353|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181354|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181355|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181356|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181357|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181358|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181359|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181360|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181361|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181362|NCT01253564|E1|Reported Event|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
181363|NCT01253525|B1|Baseline|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181364|NCT01253525|P1|Participant Flow|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181365|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181366|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181367|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181368|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181369|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181370|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181371|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181372|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181373|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181374|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181375|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181376|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181377|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181378|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181379|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181380|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181381|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181382|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181383|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181384|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181385|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181386|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181387|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181388|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181389|NCT01253525|E1|Reported Event|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
181390|NCT01253447|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
181391|NCT01253447|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
181392|NCT01253447|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
181393|NCT01253447|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
181394|NCT01253408|B4|Baseline|Total|Total of all reporting groups
181395|NCT01253408|B3|Baseline|Placebo|Placebo will be taken orally with water twice per day for two days.
181396|NCT01253408|B2|Baseline|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181397|NCT01253408|B1|Baseline|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181398|NCT01253408|P3|Participant Flow|Placebo|Placebo will be taken orally with water twice per day for two days.
181399|NCT01253408|P2|Participant Flow|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181400|NCT01253408|P1|Participant Flow|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181401|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
181402|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181403|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181404|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
181405|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181406|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181407|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
181408|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181409|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181410|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
181411|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181412|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181413|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
181417|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181418|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181419|NCT01253408|E3|Reported Event|Placebo|Placebo will be taken orally with water twice per day for two days.
181420|NCT01253408|E2|Reported Event|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
181421|NCT01253408|E1|Reported Event|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
181422|NCT01253369|B1|Baseline|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
181423|NCT01253369|P1|Participant Flow|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
181424|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
181425|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
181426|NCT01253369|E1|Reported Event|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
181427|NCT01253343|B3|Baseline|Total|Total of all reporting groups
181428|NCT01253343|B2|Baseline|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score ≤6.5.
181429|NCT01253343|B1|Baseline|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score ≥ 8.
181430|NCT01253343|P2|Participant Flow|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
181431|NCT01253343|P1|Participant Flow|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
181432|NCT01253343|O12|Outcome|High Aggression Group + TestosteroneSample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181433|NCT01253343|O11|Outcome|High Aggression Group + TestosteroneSample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181434|NCT01253343|O10|Outcome|High Aggression Group + TestosteroneSample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181435|NCT01253343|O9|Outcome|High Aggression Group + DHEASample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181436|NCT01253343|O8|Outcome|High Aggression Group + DHEASample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181437|NCT01253343|O7|Outcome|High Aggression Group + DHEASample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181438|NCT01253343|O6|Outcome|Low Aggression Group + TestosteroneSample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181439|NCT01253343|O5|Outcome|Low Aggression Group + TestosteroneSample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181440|NCT01253343|O4|Outcome|Low Aggression Group + TestosteroneSample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181441|NCT01253343|O3|Outcome|Low Aggression Group + DHEA Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181442|NCT01253343|O2|Outcome|Low Aggression Group + DHEA Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181443|NCT01253343|O1|Outcome|Low Aggression Group + DHEA Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181444|NCT01253343|O6|Outcome|High Aggression Group + Cortisol Sample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181445|NCT01253343|O5|Outcome|High Aggression Group + Cortisol Sample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181446|NCT01253343|O4|Outcome|High Aggression Group + Cortisol Sample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181447|NCT01253343|O3|Outcome|Low Aggression Group + Cortisol Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
181448|NCT01253343|O2|Outcome|Low Aggression Group + Cortisol Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
181449|NCT01253343|O1|Outcome|Low Aggression Group + Cortisol Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
181450|NCT01253343|E2|Reported Event|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
181451|NCT01253343|E1|Reported Event|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
181452|NCT01253304|B5|Baseline|Total|Total of all reporting groups
181453|NCT01253304|B4|Baseline|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181454|NCT01253304|B3|Baseline|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181455|NCT01253304|B2|Baseline|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181456|NCT01253304|B1|Baseline|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181457|NCT01253304|P4|Participant Flow|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
204855|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
181458|NCT01253304|P3|Participant Flow|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181459|NCT01253304|P2|Participant Flow|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181460|NCT01253304|P1|Participant Flow|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181461|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181462|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181463|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181464|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181465|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181466|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181467|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181468|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181469|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181470|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181471|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181472|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181473|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181474|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181475|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181476|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181477|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181478|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181479|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181480|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181481|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181482|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181483|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181484|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181485|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181486|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181487|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181488|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181489|NCT01253304|E4|Reported Event|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
181490|NCT01253304|E3|Reported Event|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
181491|NCT01253304|E2|Reported Event|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
181492|NCT01253304|E1|Reported Event|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
181493|NCT01253265|B6|Baseline|Total|Total of all reporting groups
181494|NCT01253265|B5|Baseline|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181495|NCT01253265|B4|Baseline|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181496|NCT01253265|B3|Baseline|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181497|NCT01253265|B2|Baseline|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181498|NCT01253265|B1|Baseline|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181499|NCT01253265|P5|Participant Flow|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181500|NCT01253265|P4|Participant Flow|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181501|NCT01253265|P3|Participant Flow|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181502|NCT01253265|P2|Participant Flow|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181503|NCT01253265|P1|Participant Flow|30 Milligram (mg) LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181504|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181505|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181506|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181507|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181508|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181509|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181510|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181511|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181512|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181513|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181514|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181515|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181516|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181517|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181518|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181519|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181520|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181521|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181522|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181523|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181524|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181525|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181526|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181527|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181528|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181529|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181530|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181531|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181532|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181533|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181534|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181535|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181536|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181537|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181538|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181539|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181540|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181541|NCT01253265|E5|Reported Event|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
181542|NCT01253265|E4|Reported Event|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
181543|NCT01253265|E3|Reported Event|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181544|NCT01253265|E2|Reported Event|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181545|NCT01253265|E1|Reported Event|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
181546|NCT01253187|B1|Baseline|Entire Study Population|Includes all participants treated
181566|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181567|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium) [L-5-MTHF Ca]
181547|NCT01253187|P6|Participant Flow|Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ|Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
181548|NCT01253187|P5|Participant Flow|Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca|Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
181549|NCT01253187|P4|Participant Flow|Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ|EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
181550|NCT01253187|P3|Participant Flow|Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin|EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
181551|NCT01253187|P2|Participant Flow|Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca|YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
181552|NCT01253187|P1|Participant Flow|Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin|YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
181553|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181554|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
181555|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181556|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181557|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181558|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181559|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181560|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181561|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181562|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181563|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181564|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181565|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181765|NCT01252355|E3|Reported Event|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181568|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181569|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181570|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181571|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181572|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181573|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181574|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181575|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181576|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181577|NCT01253187|E3|Reported Event|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
181578|NCT01253187|E2|Reported Event|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
181579|NCT01253187|E1|Reported Event|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
181580|NCT01253174|B1|Baseline|Entire Study Population|Includes all participants treated
181581|NCT01253174|P6|Participant Flow|Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin|Metafolin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Yasmin for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
181582|NCT01253174|P5|Participant Flow|Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca|Metafolin for Period 1; Yasmin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
181583|NCT01253174|P4|Participant Flow|Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin|EE30/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; Yasmin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
181584|NCT01253174|P3|Participant Flow|Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin|EE30/DRSP/L-5-MTHF Ca for Period 1; Yasmin for Period 2; Metafolin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
181585|NCT01253174|P2|Participant Flow|Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca|Yasmin for Period 1; Metafolin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
181611|NCT01253174|E3|Reported Event|L-5-MTHF Ca 0.451mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181612|NCT01253174|E2|Reported Event|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181586|NCT01253174|P1|Participant Flow|Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin|Yasmin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
181587|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181588|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181589|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181590|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181591|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181592|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181593|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181594|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181595|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181596|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181597|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181598|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181599|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181600|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181601|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181602|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181603|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181604|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181605|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181606|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181607|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181608|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181609|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
181610|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181613|NCT01253174|E1|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
181614|NCT01253148|B1|Baseline|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181615|NCT01253148|P1|Participant Flow|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181616|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181617|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181618|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181619|NCT01253148|E1|Reported Event|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
181620|NCT01253135|B1|Baseline|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
181621|NCT01253135|P1|Participant Flow|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
181622|NCT01253135|O2|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
181623|NCT01253135|O1|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
181624|NCT01253135|O2|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
181625|NCT01253135|O1|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
181626|NCT01253135|E2|Reported Event|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
181627|NCT01253135|E1|Reported Event|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
181628|NCT01253070|B1|Baseline|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181629|NCT01253070|P1|Participant Flow|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181652|NCT01253018|P1|Participant Flow|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
181766|NCT01252355|E2|Reported Event|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181630|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181631|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181632|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181633|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181634|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181635|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181636|NCT01253070|E1|Reported Event|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
181637|NCT01253044|B3|Baseline|Total|Total of all reporting groups
181638|NCT01253044|B2|Baseline|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181639|NCT01253044|B1|Baseline|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181640|NCT01253044|P2|Participant Flow|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181641|NCT01253044|P1|Participant Flow|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181642|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181643|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181644|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181645|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181646|NCT01253044|E2|Reported Event|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181647|NCT01253044|E1|Reported Event|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
181648|NCT01253018|B3|Baseline|Total|Total of all reporting groups
181649|NCT01253018|B2|Baseline|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
181650|NCT01253018|B1|Baseline|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181651|NCT01253018|P2|Participant Flow|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
181679|NCT01252966|E1|Reported Event|Cognitive Training|
181680|NCT01252940|B3|Baseline|Total|Total of all reporting groups
181653|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
181654|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181655|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
181656|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181657|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
181658|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181659|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
181660|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181661|NCT01253018|E2|Reported Event|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
181662|NCT01253018|E1|Reported Event|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
181663|NCT01252966|B3|Baseline|Total|Total of all reporting groups
181664|NCT01252966|B2|Baseline|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181665|NCT01252966|B1|Baseline|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181666|NCT01252966|P2|Participant Flow|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181667|NCT01252966|P1|Participant Flow|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181668|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181669|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181670|NCT01252966|O2|Outcome|Control Training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
181671|NCT01252966|O1|Outcome|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
181672|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181673|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181674|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181675|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181676|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181677|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
181678|NCT01252966|E2|Reported Event|Control Training|
181681|NCT01252940|B2|Baseline|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181682|NCT01252940|B1|Baseline|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181683|NCT01252940|P2|Participant Flow|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181684|NCT01252940|P1|Participant Flow|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
181685|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181686|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181687|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181688|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181689|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181690|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181691|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181692|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181693|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181694|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181695|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181696|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181697|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181698|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181699|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181700|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181701|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181702|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181703|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181704|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181705|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181706|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181707|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181708|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181709|NCT01252940|E3|Reported Event|SBR/Delayed Switch (After Week 24)|The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
181710|NCT01252940|E2|Reported Event|SBR/Delayed Switch (up to Week 24)|The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
181711|NCT01252940|E1|Reported Event|FTC/RPV/TDF|The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
181712|NCT01252810|B3|Baseline|Total|Total of all reporting groups
181713|NCT01252810|B2|Baseline|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
181714|NCT01252810|B1|Baseline|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
181715|NCT01252810|P2|Participant Flow|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
181716|NCT01252810|P1|Participant Flow|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
181717|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
181718|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
181719|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
181720|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
181721|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
181722|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
181723|NCT01252810|E2|Reported Event|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
181724|NCT01252810|E1|Reported Event|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.
181725|NCT01252355|B4|Baseline|Total|Total of all reporting groups
181726|NCT01252355|B3|Baseline|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181727|NCT01252355|B2|Baseline|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181728|NCT01252355|B1|Baseline|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181729|NCT01252355|P3|Participant Flow|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181730|NCT01252355|P2|Participant Flow|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181731|NCT01252355|P1|Participant Flow|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181732|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181733|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181734|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181735|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181736|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181737|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181738|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181739|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181740|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181741|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181742|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181743|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181744|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181745|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181746|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181747|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181748|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181749|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181750|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181751|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181752|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181753|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181754|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181755|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181756|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181757|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181758|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181759|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181760|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181761|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181762|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
181763|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
181764|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181767|NCT01252355|E1|Reported Event|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
181768|NCT01252290|B1|Baseline|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181769|NCT01252290|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181770|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181771|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181772|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181773|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181774|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181775|NCT01252290|E1|Reported Event|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181776|NCT01252277|B1|Baseline|Lovaza™|Lovaza™ (two 1 gram capsules twice daily) for six months
181777|NCT01252277|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
181778|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
181779|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
181780|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
181781|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
181782|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
181783|NCT01252277|E1|Reported Event|Lovaza™|"Lovaza™ (two 1 gram capsules twice daily) for six months~Lovaza™: 4 capsules daily for 6 months"
181784|NCT01252238|B4|Baseline|Total|Total of all reporting groups
181785|NCT01252238|B3|Baseline|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
181786|NCT01252238|B2|Baseline|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
181787|NCT01252238|B1|Baseline|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
181788|NCT01252238|P3|Participant Flow|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
181789|NCT01252238|P2|Participant Flow|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
181790|NCT01252238|P1|Participant Flow|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
181791|NCT01252238|O3|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
181792|NCT01252238|O2|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
181793|NCT01252238|O1|Outcome|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
181794|NCT01252238|E3|Reported Event|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
181795|NCT01252238|E2|Reported Event|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
181796|NCT01252238|E1|Reported Event|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
181797|NCT01252186|B4|Baseline|Total|Total of all reporting groups
181798|NCT01252186|B3|Baseline|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181799|NCT01252186|B2|Baseline|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181800|NCT01252186|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181801|NCT01252186|P3|Participant Flow|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181802|NCT01252186|P2|Participant Flow|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181803|NCT01252186|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181804|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181805|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181806|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181807|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181902|NCT01252095|O2|Outcome|50 mg Dose|50 mg PG545/week
181903|NCT01252095|O1|Outcome|25 mg Dose|25 mg PG545/week
181808|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181809|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181810|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181811|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181812|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181813|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181814|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181815|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181816|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181817|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181818|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181819|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181820|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181821|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181822|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181823|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181824|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181825|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181826|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181827|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181828|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181829|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181830|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181831|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181832|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181833|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181834|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181835|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181836|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181837|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181838|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181839|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181840|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181841|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181842|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181843|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181844|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181845|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181846|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181847|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181848|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181849|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181850|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181851|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181852|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181853|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181854|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181855|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181856|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181857|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181858|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181859|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181860|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181861|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181862|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181863|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181864|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181865|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181866|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181867|NCT01252186|E3|Reported Event|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181868|NCT01252186|E2|Reported Event|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
181869|NCT01252186|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
181870|NCT01252147|B1|Baseline|All Participants|
181871|NCT01252147|P1|Participant Flow|All Participants|
181872|NCT01252147|O1|Outcome|All Participants|
181873|NCT01252147|O1|Outcome|All Participants|
181874|NCT01252147|E1|Reported Event|All Participants|
181875|NCT01252134|B1|Baseline|Overall|All enrolled participants
181876|NCT01252134|P6|Participant Flow|OTE, Then Synergi, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181877|NCT01252134|P5|Participant Flow|OTE, Then Biotrue, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181878|NCT01252134|P4|Participant Flow|Biotrue, Then Synergi, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181879|NCT01252134|P3|Participant Flow|Biotrue, Then OTE, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181880|NCT01252134|P2|Participant Flow|Synergi, Then OTE, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181881|NCT01252134|P1|Participant Flow|Synergi, Then Biotrue, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
181882|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181883|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181884|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181885|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181886|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181887|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181888|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181889|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181890|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181891|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181892|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181893|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181894|NCT01252134|E3|Reported Event|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181895|NCT01252134|E2|Reported Event|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181896|NCT01252134|E1|Reported Event|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
181897|NCT01252095|B3|Baseline|Total|Total of all reporting groups
181898|NCT01252095|B2|Baseline|50 mg Dose|50 mg PG545/week
181899|NCT01252095|B1|Baseline|25 mg Dose|25 mg PG545/week
181900|NCT01252095|P2|Participant Flow|50 mg Dose|50 mg PG545/week
181901|NCT01252095|P1|Participant Flow|25 mg Dose|25 mg PG545/week
181907|NCT01251978|B2|Baseline|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
181908|NCT01251978|B1|Baseline|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181909|NCT01251978|P2|Participant Flow|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
181910|NCT01251978|P1|Participant Flow|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181911|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
181912|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181913|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
181914|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181915|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181916|NCT01251978|E2|Reported Event|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
181917|NCT01251978|E1|Reported Event|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
181918|NCT01251952|B1|Baseline|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
181919|NCT01251952|P1|Participant Flow|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
181920|NCT01251952|O1|Outcome|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
181921|NCT01251952|E1|Reported Event|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
181922|NCT01251770|B3|Baseline|Total|Total of all reporting groups
181923|NCT01251770|B2|Baseline|ClNa 0.45%|maintenance solution with ClNa 0.45%
181924|NCT01251770|B1|Baseline|ClNa 0.3%|maintenance solution with ClNa 0.3%
181925|NCT01251770|P2|Participant Flow|ClNa 0.45%|maintenance solution with ClNa 0.45%
181926|NCT01251770|P1|Participant Flow|ClNa 0.3%|maintenance solution with ClNa 0.3%
181927|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
181928|NCT01251770|O1|Outcome|ClNa 0.22%|maintenance solution with ClNa 0.22%
181929|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
181930|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
181931|NCT01251770|E2|Reported Event|ClNa 0.45%|maintenance solution with ClNa 0.45%
181932|NCT01251770|E1|Reported Event|ClNa 0.3%|maintenance solution with ClNa 0.3%
181933|NCT01251757|B4|Baseline|Total|Total of all reporting groups
181934|NCT01251757|B3|Baseline|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
181935|NCT01251757|B2|Baseline|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
181936|NCT01251757|B1|Baseline|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
181937|NCT01251757|P3|Participant Flow|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
181938|NCT01251757|P2|Participant Flow|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
181939|NCT01251757|P1|Participant Flow|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
181940|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
181941|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
181942|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
181943|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
181944|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
181945|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
181946|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
181947|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
181948|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
181949|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
181950|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
181951|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
181952|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
181953|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
181954|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
181955|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
181956|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
181957|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
181958|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
181959|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
181960|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
181961|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
181962|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
181963|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
181964|NCT01251757|E3|Reported Event|Enhanced IVR (IVR+)|usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence
181965|NCT01251757|E2|Reported Event|Interactive Voice Recognition (IVR)|usual care plus automated phone calls
181966|NCT01251757|E1|Reported Event|Usual Care (UC)|usual medical care
181967|NCT01251653|B10|Baseline|Total|Total of all reporting groups
181968|NCT01251653|B9|Baseline|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181969|NCT01251653|B8|Baseline|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181970|NCT01251653|B7|Baseline|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181971|NCT01251653|B6|Baseline|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
181972|NCT01251653|B5|Baseline|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181973|NCT01251653|B4|Baseline|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181974|NCT01251653|B3|Baseline|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181975|NCT01251653|B2|Baseline|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181976|NCT01251653|B1|Baseline|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182203|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
181977|NCT01251653|P9|Participant Flow|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181978|NCT01251653|P8|Participant Flow|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181979|NCT01251653|P7|Participant Flow|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181980|NCT01251653|P6|Participant Flow|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
181981|NCT01251653|P5|Participant Flow|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181982|NCT01251653|P4|Participant Flow|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181983|NCT01251653|P3|Participant Flow|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181984|NCT01251653|P2|Participant Flow|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181985|NCT01251653|P1|Participant Flow|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
181986|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181987|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181988|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181989|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181990|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181991|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181992|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181993|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181994|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181995|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181996|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181997|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181998|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
181999|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182000|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182001|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182002|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182003|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182004|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182005|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182006|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182007|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182008|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182009|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182010|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
182011|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182012|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
182013|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182014|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
182015|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182016|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
182017|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182018|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
182019|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182020|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
182021|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182022|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182023|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182024|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182025|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182026|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182027|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182028|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182029|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182030|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182031|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182032|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182033|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182034|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182035|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182036|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182204|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182037|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182038|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182039|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182040|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182041|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182042|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182043|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182044|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182045|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182046|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182047|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182048|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182049|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182050|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182051|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182052|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182053|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182054|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182055|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182056|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182057|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182058|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182059|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182060|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182061|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182062|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182063|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182064|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182065|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182066|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182067|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182068|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182069|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182070|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182071|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182072|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182073|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182074|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182075|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182076|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182077|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182078|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182079|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182080|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182081|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182082|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182083|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182084|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182085|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182086|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182087|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182088|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182089|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182090|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182091|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182092|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182093|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182094|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
182095|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182096|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182097|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182098|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182099|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182100|NCT01251653|E9|Reported Event|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182101|NCT01251653|E8|Reported Event|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182102|NCT01251653|E7|Reported Event|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182103|NCT01251653|E6|Reported Event|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
182104|NCT01251653|E5|Reported Event|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182105|NCT01251653|E4|Reported Event|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182106|NCT01251653|E3|Reported Event|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182107|NCT01251653|E2|Reported Event|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182108|NCT01251653|E1|Reported Event|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
182109|NCT01251354|B1|Baseline|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182110|NCT01251354|P1|Participant Flow|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182111|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182112|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182113|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182114|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182115|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182116|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182117|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182118|NCT01251354|E1|Reported Event|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
182119|NCT01251315|B7|Baseline|Total|Total of all reporting groups
182120|NCT01251315|B6|Baseline|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
182121|NCT01251315|B5|Baseline|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group ( 1200mg oral X1)
182122|NCT01251315|B4|Baseline|Placebo-B|High dose oral X1
182123|NCT01251315|B3|Baseline|Proimmune 200-A|Proimmune 200 low dose group (3000mg oral X 1)
182124|NCT01251315|B2|Baseline|N Acetyl Cysteine-A|N Acetyl cysteine low dose group (600mg oral X1)
182125|NCT01251315|B1|Baseline|Placebo-A|low dose oral x1
182126|NCT01251315|P6|Participant Flow|Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)|Proimmune 200 (high dose, 6000 mg oral as a single dose)
182127|NCT01251315|P5|Participant Flow|N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose)|N Acetyl cysteine (high dose 1200 mg oral as a single dose)
182128|NCT01251315|P4|Participant Flow|Placebo High Dose Group, Given Oral as a Single Dose|Placebo high dose group, given oral as a single dose
182129|NCT01251315|P3|Participant Flow|Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose)|Proimmune 200 (low dose, 3000 mg oral as a single dose)
182130|NCT01251315|P2|Participant Flow|N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose)|N Acetyl cysteine (low dose, 600mg oral as a single dose)
182131|NCT01251315|P1|Participant Flow|Placebo Low Dose Group, Given Oral as a Single Dose|Placebo low dose group, given oral as a single dose
182132|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group
182133|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
182134|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
182135|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group
182136|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
182137|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
182138|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
182139|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group (1200 mg oral x1)
182140|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
182141|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group ( 3000mg oral x1)
182142|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group ( 600mg oral x1)
182143|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
182144|NCT01251315|E6|Reported Event|Proimmune 200-B|Proimmune 200 High dose group
182145|NCT01251315|E5|Reported Event|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
182146|NCT01251315|E4|Reported Event|Placebo-B|High dose group
182147|NCT01251315|E3|Reported Event|Proimmune 200-A|Proimmune 200 low dose group
182148|NCT01251315|E2|Reported Event|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
182149|NCT01251315|E1|Reported Event|Placebo-A|low dose group
182150|NCT01251146|B3|Baseline|Total|Total of all reporting groups
182151|NCT01251146|B2|Baseline|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182152|NCT01251146|B1|Baseline|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182153|NCT01251146|P2|Participant Flow|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182154|NCT01251146|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182155|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182205|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182206|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182207|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182208|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
204856|NCT01181011|O2|Outcome|Amlodipine 5mg|
182156|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182157|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182158|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182159|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182160|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182161|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182162|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182163|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182209|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182210|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182211|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182212|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182213|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182214|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182164|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182165|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182166|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182167|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182168|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182169|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182170|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182171|NCT01251146|E2|Reported Event|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182215|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182216|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182217|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182218|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182219|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182220|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182172|NCT01251146|E1|Reported Event|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
182173|NCT01251120|B3|Baseline|Total|Total of all reporting groups
182174|NCT01251120|B2|Baseline|Placebo|Participants received Non-biologic DMARDs (including methotrexate) according to current best practice
182175|NCT01251120|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
182176|NCT01251120|P2|Participant Flow|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182177|NCT01251120|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182178|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182179|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182180|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182181|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182182|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182183|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182184|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182185|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182186|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182187|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182188|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182189|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182190|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182191|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182192|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182193|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182194|NCT01251120|E2|Reported Event|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182195|NCT01251120|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
182196|NCT01251042|B3|Baseline|Total|Total of all reporting groups
182197|NCT01251042|B2|Baseline|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182198|NCT01251042|B1|Baseline|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182199|NCT01251042|P2|Participant Flow|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182200|NCT01251042|P1|Participant Flow|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182201|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182221|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182222|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182223|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182224|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182225|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182226|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182227|NCT01251042|E2|Reported Event|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
182228|NCT01251042|E1|Reported Event|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
182229|NCT01250990|B3|Baseline|Total|Total of all reporting groups
182230|NCT01250990|B2|Baseline|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
182231|NCT01250990|B1|Baseline|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
182232|NCT01250990|P2|Participant Flow|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
182233|NCT01250990|P1|Participant Flow|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
182234|NCT01250990|O2|Outcome|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
182235|NCT01250990|O1|Outcome|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
182236|NCT01250990|E2|Reported Event|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
182237|NCT01250990|E1|Reported Event|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
182238|NCT01250925|B4|Baseline|Total|Total of all reporting groups
182239|NCT01250925|B3|Baseline|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182240|NCT01250925|B2|Baseline|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182241|NCT01250925|B1|Baseline|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182242|NCT01250925|P3|Participant Flow|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182243|NCT01250925|P2|Participant Flow|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182244|NCT01250925|P1|Participant Flow|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182245|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182246|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182247|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182248|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182249|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182250|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182251|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182252|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182253|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182254|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182255|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182256|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182257|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182258|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182259|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182260|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182261|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182262|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182263|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182264|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182265|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182266|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182267|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182268|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182269|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182270|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182271|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182272|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182273|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182274|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182275|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182276|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182277|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182278|NCT01250925|E3|Reported Event|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182279|NCT01250925|E2|Reported Event|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182280|NCT01250925|E1|Reported Event|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
182281|NCT01250899|B3|Baseline|Total|Total of all reporting groups
182282|NCT01250899|B2|Baseline|Vitamin D Insufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
182283|NCT01250899|B1|Baseline|Vitamin D Sufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
182284|NCT01250899|P2|Participant Flow|Vitamin D Insufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
182285|NCT01250899|P1|Participant Flow|Vitamin D Sufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
182286|NCT01250899|O1|Outcome|Vitamin D Insufficient|Baseline 25(OH)D <30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
182287|NCT01250899|E1|Reported Event|Vitamin D Insufficient|25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation).
182288|NCT01250834|B1|Baseline|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
182289|NCT01250834|P1|Participant Flow|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
182290|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182291|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182292|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182293|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182294|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182295|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182296|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182297|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182298|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182299|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182300|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
182301|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182302|NCT01250834|E3|Reported Event|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
182303|NCT01250834|E2|Reported Event|1.5 mg LY2189265|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
182304|NCT01250834|E1|Reported Event|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
182305|NCT01250769|B5|Baseline|Total|Total of all reporting groups
182306|NCT01250769|B4|Baseline|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182307|NCT01250769|B3|Baseline|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182308|NCT01250769|B2|Baseline|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182309|NCT01250769|B1|Baseline|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182310|NCT01250769|P4|Participant Flow|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182311|NCT01250769|P3|Participant Flow|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182312|NCT01250769|P2|Participant Flow|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182313|NCT01250769|P1|Participant Flow|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182314|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182315|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182316|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182317|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182318|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182319|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182320|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182321|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182322|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182323|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182324|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182325|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182326|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182327|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182328|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182329|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182330|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182331|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182332|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182333|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182334|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
204857|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182335|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182336|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182337|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182338|NCT01250769|E4|Reported Event|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
182339|NCT01250769|E3|Reported Event|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
182340|NCT01250769|E2|Reported Event|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
182341|NCT01250769|E1|Reported Event|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
182342|NCT01250756|B3|Baseline|Total|Total of all reporting groups
182343|NCT01250756|B2|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182344|NCT01250756|B1|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182345|NCT01250756|P2|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182346|NCT01250756|P1|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182347|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182348|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182349|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182350|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182351|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182352|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182353|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182401|NCT01250730|P1|Participant Flow|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182402|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182354|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182355|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182356|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182357|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182358|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182359|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182360|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182361|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182362|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182363|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182364|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182365|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182366|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182403|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182404|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
204858|NCT01181011|O2|Outcome|Amlodipine 5mg|
182367|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182368|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182369|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182370|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182371|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182372|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182373|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182374|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182375|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182376|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182377|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182378|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182379|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182405|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182406|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182407|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182380|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182381|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182382|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182383|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182384|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182385|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182386|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
182387|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
182388|NCT01250756|E7|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
182389|NCT01250756|E6|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
182390|NCT01250756|E5|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
182391|NCT01250756|E4|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
182392|NCT01250756|E3|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
182393|NCT01250756|E2|Reported Event|DTaP (Catch-up 7vPnC)- Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
182394|NCT01250756|E1|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
182395|NCT01250730|B4|Baseline|Total|Total of all reporting groups
182396|NCT01250730|B3|Baseline|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182397|NCT01250730|B2|Baseline|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182398|NCT01250730|B1|Baseline|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182399|NCT01250730|P3|Participant Flow|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182400|NCT01250730|P2|Participant Flow|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182408|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182409|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182410|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182411|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182412|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182413|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182414|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182415|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182416|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182417|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182418|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182419|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182420|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182421|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182422|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182423|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182424|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182425|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182426|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182427|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182428|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182429|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182430|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182431|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182432|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182433|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182434|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182435|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182436|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182437|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182438|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182439|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182440|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182441|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182442|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182443|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182444|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182445|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182446|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182447|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182448|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182449|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182450|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182451|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182452|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
182453|NCT01250730|E3|Reported Event|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
182454|NCT01250730|E2|Reported Event|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
182455|NCT01250730|E1|Reported Event|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
183998|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
182456|NCT01250717|B1|Baseline|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
182457|NCT01250717|P1|Participant Flow|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
182458|NCT01250717|O1|Outcome|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
182459|NCT01250717|E1|Reported Event|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
182460|NCT01250509|B3|Baseline|Total|Total of all reporting groups
182461|NCT01250509|B2|Baseline|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182462|NCT01250509|B1|Baseline|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182463|NCT01250509|P2|Participant Flow|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182464|NCT01250509|P1|Participant Flow|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182465|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182466|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182467|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182468|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182469|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182470|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182471|NCT01250509|O2|Outcome|Waitlist|
182472|NCT01250509|O1|Outcome|CALMM|
182473|NCT01250509|E2|Reported Event|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
182474|NCT01250509|E1|Reported Event|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
182475|NCT01250418|B3|Baseline|Total|Total of all reporting groups
182476|NCT01250418|B2|Baseline|No Ketamine|No ketamine added to anesthesia regimen
182477|NCT01250418|B1|Baseline|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
182478|NCT01250418|P2|Participant Flow|No Ketamine|No ketamine added to anesthesia regimen
182479|NCT01250418|P1|Participant Flow|Ketamine Group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
182480|NCT01250418|O2|Outcome|No Ketamine|No ketamine added to anesthesia regimen
182481|NCT01250418|O1|Outcome|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
182482|NCT01250418|E2|Reported Event|Ketamine Group|Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
182483|NCT01250418|E1|Reported Event|No Ketamine Added to Anesthesia Regimen|No ketamine added to the patients anesthesia regimen
182484|NCT01250379|B3|Baseline|Total|Total of all reporting groups
182485|NCT01250379|B2|Baseline|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182564|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
204859|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182486|NCT01250379|B1|Baseline|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182487|NCT01250379|P2|Participant Flow|Chemotherapy Plus Bevacizumab (CT+BV) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182488|NCT01250379|P1|Participant Flow|Chemotherapy (CT) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182489|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182490|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182491|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182492|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182493|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182565|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
183999|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
182494|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182495|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182496|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182497|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182498|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182499|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182500|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182501|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182566|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182502|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182503|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182504|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182505|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182506|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182507|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182508|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182509|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182567|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182568|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
204860|NCT01181011|O2|Outcome|Amlodipine 5mg|
182510|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182511|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182512|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182513|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182514|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182515|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182516|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182517|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182569|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182518|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182519|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182520|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182521|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182522|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182523|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182524|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182525|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182570|NCT01250184|E3|Reported Event|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182571|NCT01250184|E2|Reported Event|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182526|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182527|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182528|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182529|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182530|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182531|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182532|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182533|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182572|NCT01250184|E1|Reported Event|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182534|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182535|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182536|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182537|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182538|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182539|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182540|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182541|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182573|NCT01250171|B4|Baseline|Total|Total of all reporting groups
182574|NCT01250171|B3|Baseline|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182575|NCT01250171|B2|Baseline|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
204861|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182542|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182543|NCT01250379|E2|Reported Event|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182544|NCT01250379|E1|Reported Event|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
182545|NCT01250184|B4|Baseline|Total|Total of all reporting groups
182546|NCT01250184|B3|Baseline|Blocking the MTP|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182547|NCT01250184|B2|Baseline|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182548|NCT01250184|B1|Baseline|Blocking the MTP Plus Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182549|NCT01250184|P3|Participant Flow|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182550|NCT01250184|P2|Participant Flow|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182551|NCT01250184|P1|Participant Flow|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182552|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182553|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182554|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182555|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182556|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182557|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182558|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182559|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182560|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
182561|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
182562|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
182563|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
204862|NCT01181011|O2|Outcome|Telmisartan 80mg|
182576|NCT01250171|B1|Baseline|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182577|NCT01250171|P3|Participant Flow|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182578|NCT01250171|P2|Participant Flow|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182579|NCT01250171|P1|Participant Flow|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182580|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182581|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182582|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182583|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182584|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182585|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182586|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182587|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182588|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182589|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182590|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182591|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182592|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182593|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182594|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182595|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182596|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182597|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182598|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182599|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182600|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182601|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182602|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182603|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182604|NCT01250171|E3|Reported Event|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
182605|NCT01250171|E2|Reported Event|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
182606|NCT01250171|E1|Reported Event|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
182607|NCT01250145|B3|Baseline|Total|Total of all reporting groups
182608|NCT01250145|B2|Baseline|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
182609|NCT01250145|B1|Baseline|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
182610|NCT01250145|P2|Participant Flow|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
182611|NCT01250145|P1|Participant Flow|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
182612|NCT01250145|O2|Outcome|Placebo Patch|"Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: placebo patch given once for at least 6 hours"
182613|NCT01250145|O1|Outcome|Active Patch|"Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
182614|NCT01250145|O6|Outcome|Part B: Placebo Patch - 24 Hours Post Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
182615|NCT01250145|O5|Outcome|Part B: Placebo Patch - 1 Hour Post Patch Removal|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
184000|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
182616|NCT01250145|O4|Outcome|Part B: Placebo Patch - Prior to Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
182617|NCT01250145|O3|Outcome|Part B: Active Patch - 24 Hours Post Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
182618|NCT01250145|O2|Outcome|Part B: Active Patch - 1 Hour Post Patch Removal|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
182619|NCT01250145|O1|Outcome|Part B: Active Patch - Prior to Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
182620|NCT01250145|O2|Outcome|Placebo Patch|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
182621|NCT01250145|O1|Outcome|Active Patch|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
182622|NCT01250145|O6|Outcome|Part A: Placebo Patch - 24 Hours Post Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
182623|NCT01250145|O5|Outcome|Part A: Placebo Patch - 1 Hour Post Patch Removal|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
182624|NCT01250145|O4|Outcome|Part A: Placebo Patch - Prior to Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
182625|NCT01250145|O3|Outcome|Part A: Active Patch - 24 Hours Post Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
182626|NCT01250145|O2|Outcome|Part A: Active Patch - 1 Hour Post Patch Removal|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
182627|NCT01250145|O1|Outcome|Part A: Active Patch - Prior to Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
182628|NCT01250145|E2|Reported Event|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
182629|NCT01250145|E1|Reported Event|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
182630|NCT01250119|B1|Baseline|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
182631|NCT01250119|P2|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
182632|NCT01250119|P1|Participant Flow|Non-small-cell Lung Cancer (NSCLC) Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
182633|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182634|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182635|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182636|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182637|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182638|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182639|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182640|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182641|NCT01250119|O2|Outcome|EGFR Negative|All participants who tested negative for EGFR mutations were included in this group.
182642|NCT01250119|O1|Outcome|EGFR Positive|All participants who tested positive for EGFR mutations were included in this group.
182643|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182644|NCT01250119|O1|Outcome|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
182645|NCT01250119|E1|Reported Event|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
182646|NCT01250054|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
182647|NCT01250054|P2|Participant Flow|Comfilcon A /Lotrafilcon B|Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
182648|NCT01250054|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
182649|NCT01250054|O2|Outcome|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
182650|NCT01250054|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
182651|NCT01250054|E2|Reported Event|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
182652|NCT01250054|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
182653|NCT01250002|B3|Baseline|Total|Total of all reporting groups
182654|NCT01250002|B2|Baseline|Placebo|Group B (control group) will receive the same volume of saline infusion.
182655|NCT01250002|B1|Baseline|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
182656|NCT01250002|P2|Participant Flow|Placebo|Group B (control group) will receive the same volume of saline infusion.
182657|NCT01250002|P1|Participant Flow|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
182658|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
182659|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
182660|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
182661|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
182662|NCT01250002|E2|Reported Event|Placebo|Group B (control group) will receive the same volume of saline infusion.
182663|NCT01250002|E1|Reported Event|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
182664|NCT01249872|B7|Baseline|Total|Total of all reporting groups
182665|NCT01249872|B6|Baseline|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182666|NCT01249872|B5|Baseline|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182667|NCT01249872|B4|Baseline|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182668|NCT01249872|B3|Baseline|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182669|NCT01249872|B2|Baseline|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182670|NCT01249872|B1|Baseline|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182671|NCT01249872|P6|Participant Flow|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182672|NCT01249872|P5|Participant Flow|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182673|NCT01249872|P4|Participant Flow|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
204863|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182674|NCT01249872|P3|Participant Flow|GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182675|NCT01249872|P2|Participant Flow|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182676|NCT01249872|P1|Participant Flow|GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182677|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182678|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182679|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182680|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182681|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182682|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182683|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182684|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182685|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182686|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182687|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182688|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182689|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182783|NCT01249417|P3|Participant Flow|Placebo|"Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.~Placebo: I.M. injection on day 1 of a single treatment cycle."
184001|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
182690|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182691|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182692|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182693|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182694|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182695|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182696|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182697|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182698|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182699|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182700|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182701|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182702|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182703|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182704|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182705|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182784|NCT01249417|P2|Participant Flow|Dysport 15 U/Kg|"15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
204864|NCT01181011|O2|Outcome|Telmisartan 80mg|
182706|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182707|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182708|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182709|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182710|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182711|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182712|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182713|NCT01249872|E6|Reported Event|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182714|NCT01249872|E5|Reported Event|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182715|NCT01249872|E4|Reported Event|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182716|NCT01249872|E3|Reported Event|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182717|NCT01249872|E2|Reported Event|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182718|NCT01249872|E1|Reported Event|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
182719|NCT01249664|B3|Baseline|Total|Total of all reporting groups
182720|NCT01249664|B2|Baseline|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182721|NCT01249664|B1|Baseline|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182785|NCT01249417|P1|Participant Flow|Dysport 10 U/Kg|"10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
182786|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182722|NCT01249664|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182723|NCT01249664|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182724|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182725|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182726|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182727|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182728|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182729|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182730|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182731|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182732|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182733|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182771|NCT01249664|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.
182734|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182735|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182736|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182737|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182738|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182739|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182740|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182741|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182742|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182743|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182744|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182745|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182772|NCT01249651|B1|Baseline|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182773|NCT01249651|P1|Participant Flow|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182774|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182775|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182776|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182746|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182747|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182748|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182749|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182750|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182751|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182752|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182753|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182754|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182755|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182756|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182757|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182777|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182778|NCT01249651|E1|Reported Event|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
182779|NCT01249417|B4|Baseline|Total|Total of all reporting groups
182780|NCT01249417|B3|Baseline|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
204865|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182758|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182759|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182760|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182761|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182762|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182763|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182764|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182765|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182766|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182767|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
182768|NCT01249664|E4|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 44)|Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
182769|NCT01249664|E3|Reported Event|Aflibercept Injection (Until Week 44)|Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.
182770|NCT01249664|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.
182781|NCT01249417|B2|Baseline|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182782|NCT01249417|B1|Baseline|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
204866|NCT01181011|O2|Outcome|Telmisartan 80mg|
182787|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182788|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182789|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182790|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182791|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182792|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182793|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182794|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182795|NCT01249417|E3|Reported Event|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182796|NCT01249417|E2|Reported Event|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182797|NCT01249417|E1|Reported Event|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
182798|NCT01249274|B3|Baseline|Total|Total of all reporting groups
182799|NCT01249274|B2|Baseline|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182800|NCT01249274|B1|Baseline|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182801|NCT01249274|P2|Participant Flow|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182802|NCT01249274|P1|Participant Flow|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182803|NCT01249274|O2|Outcome|Progesterone|Progesterone: 100mgs progesterone twice daily
182804|NCT01249274|O1|Outcome|Placebo|Placebo: Matched placebo pills to be taken twice daily
182805|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182806|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182807|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182808|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182809|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182810|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182811|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182812|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182813|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182814|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182815|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182816|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182817|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182818|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182819|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182820|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182821|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182822|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182823|NCT01249274|E2|Reported Event|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
182824|NCT01249274|E1|Reported Event|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
182825|NCT01249261|B3|Baseline|Total|Total of all reporting groups
182826|NCT01249261|B2|Baseline|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182827|NCT01249261|B1|Baseline|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182828|NCT01249261|P2|Participant Flow|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182829|NCT01249261|P1|Participant Flow|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182830|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182831|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182832|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182833|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182834|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182835|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182836|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182837|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182838|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182839|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182840|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182841|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182842|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182843|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182844|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182845|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182846|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182847|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182848|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182849|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182850|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182851|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182852|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182853|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182854|NCT01249261|E2|Reported Event|Risedronate|Risedronate 5mg years 1-7, no drug year 8
182855|NCT01249261|E1|Reported Event|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
182856|NCT01249157|B1|Baseline|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
182857|NCT01249157|P1|Participant Flow|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
182858|NCT01249157|O1|Outcome|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
182859|NCT01249157|E1|Reported Event|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
182860|NCT01249131|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
182861|NCT01249131|P6|Participant Flow|Treatment C First, Then Treatment B, Followed by Treatment A|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
182862|NCT01249131|P5|Participant Flow|Treatment C First, Then Treatment A, Followed by Treatment B|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
182863|NCT01249131|P4|Participant Flow|Treatment B First, Then Treatment C, Followed by Treatment A|Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
182864|NCT01249131|P3|Participant Flow|Treatment B First, Then Treatment A, Followed by Treatment C|Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
182865|NCT01249131|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
182866|NCT01249131|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
182867|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182868|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182869|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182870|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182871|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182872|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182873|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182874|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182875|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182876|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182877|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182878|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182879|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182880|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182881|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182882|NCT01249131|E3|Reported Event|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
182883|NCT01249131|E2|Reported Event|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182884|NCT01249131|E1|Reported Event|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
182885|NCT01249118|B1|Baseline|Entire Study Population|"Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.~Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period."
182886|NCT01249118|P3|Participant Flow|Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period.
182887|NCT01249118|P2|Participant Flow|Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
182888|NCT01249118|P1|Participant Flow|Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
182889|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182890|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182891|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182892|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182893|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182894|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182895|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182896|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182897|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182898|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182899|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182900|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182901|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182902|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182903|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182904|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182905|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182906|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182907|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182908|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182909|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182910|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182911|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182912|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182913|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182914|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182915|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182916|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182917|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
182918|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
182919|NCT01249118|E2|Reported Event|GDC-0973 20 mg Oral|Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study.
182920|NCT01249118|E1|Reported Event|GDC-0973 2 mg IV|Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study.
182921|NCT01249092|B1|Baseline|Pentoxifylline 400 mg/d|All patients received same intervention.
182922|NCT01249092|P1|Participant Flow|Pentoxifylline 400 mg/d|All patients received same intervention.
182923|NCT01249092|O1|Outcome|Pentoxifylline 400 mg/d|Descriptive information only of small open label pilot. Small patient number not amenable for any valid statistical comparisons regarding side effects. All patients received same intervention. No SAEs occurred.
182924|NCT01249092|O1|Outcome|Change in Serum TIMP-1 (Tissue Inhibitor metalloproteinase1)|
182925|NCT01249092|O1|Outcome|Change in Alkaline Phosphatase After Pentoxifylline Therapy|
182926|NCT01249092|E1|Reported Event|Pentoxifylline 400 mg/d|All patients received same intervention.
182927|NCT01248936|B1|Baseline|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
182928|NCT01248936|P1|Participant Flow|Overall Trial|Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
182929|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182930|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182931|NCT01248936|O1|Outcome|Overall Trial|Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor
182932|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182933|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182934|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182935|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182936|NCT01248936|E1|Reported Event|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
182937|NCT01248884|B4|Baseline|Total|Total of all reporting groups
182938|NCT01248884|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182939|NCT01248884|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182940|NCT01248884|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182941|NCT01248884|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182942|NCT01248884|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182943|NCT01248884|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182944|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182945|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182946|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182947|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182948|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182949|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182950|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182951|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182952|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182953|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182954|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182955|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182956|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
184002|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
182957|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182958|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182959|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182960|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182961|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182962|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182963|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182964|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182965|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182966|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182967|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182968|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182969|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182970|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182971|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182972|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182973|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182974|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182975|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
184003|NCT01244516|E3|Reported Event|Comfilcon A|comfilcon A, base curve 8.60
182976|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182977|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182978|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182979|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182980|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182981|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182982|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182983|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182984|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182985|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182986|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182987|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182988|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182989|NCT01248884|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
182990|NCT01248884|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182991|NCT01248884|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
182992|NCT01248793|B3|Baseline|Total|Total of all reporting groups
182993|NCT01248793|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
182994|NCT01248793|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
182995|NCT01248793|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
182996|NCT01248793|P1|Participant Flow|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
182997|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
204867|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
182998|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
182999|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
183000|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
183001|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
183002|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
183003|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
183004|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
183005|NCT01248793|E2|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
183006|NCT01248793|E1|Reported Event|Placebo -> Golimumab 50 mg|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48
183007|NCT01248780|B3|Baseline|Total|Total of all reporting groups
183008|NCT01248780|B2|Baseline|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183009|NCT01248780|B1|Baseline|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183010|NCT01248780|P2|Participant Flow|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183011|NCT01248780|P1|Participant Flow|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183012|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183013|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183014|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183015|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183016|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183017|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183018|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183019|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183020|NCT01248780|E2|Reported Event|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183021|NCT01248780|E1|Reported Event|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
183022|NCT01248728|B3|Baseline|Total|Total of all reporting groups
183023|NCT01248728|B2|Baseline|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
183040|NCT01248468|B3|Baseline|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183514|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183024|NCT01248728|B1|Baseline|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
183025|NCT01248728|P2|Participant Flow|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
183026|NCT01248728|P1|Participant Flow|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
183027|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
183028|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
183029|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
183030|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
183031|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
183032|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
183033|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
183034|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
183035|NCT01248728|O2|Outcome|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
183036|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
183037|NCT01248728|E2|Reported Event|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
183038|NCT01248728|E1|Reported Event|Omega-3 Fatty Acids|"Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.~Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process."
183039|NCT01248468|B4|Baseline|Total|Total of all reporting groups
183041|NCT01248468|B2|Baseline|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183042|NCT01248468|B1|Baseline|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183043|NCT01248468|P3|Participant Flow|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183044|NCT01248468|P2|Participant Flow|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183045|NCT01248468|P1|Participant Flow|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183046|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183047|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183048|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183049|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183050|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183051|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183052|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183053|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183054|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183055|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183056|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183057|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183058|NCT01248468|E3|Reported Event|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183059|NCT01248468|E2|Reported Event|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
183060|NCT01248468|E1|Reported Event|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
183061|NCT01248455|B1|Baseline|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
183062|NCT01248455|P1|Participant Flow|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
183063|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
183064|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
183065|NCT01248455|E1|Reported Event|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
183066|NCT01248364|B5|Baseline|Total|Total of all reporting groups
183067|NCT01248364|B4|Baseline|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183068|NCT01248364|B3|Baseline|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183069|NCT01248364|B2|Baseline|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183070|NCT01248364|B1|Baseline|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183071|NCT01248364|P4|Participant Flow|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183072|NCT01248364|P3|Participant Flow|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183073|NCT01248364|P2|Participant Flow|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183305|NCT01245595|B1|Baseline|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
183074|NCT01248364|P1|Participant Flow|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183075|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183076|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183077|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183078|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183079|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183080|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183081|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183082|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183083|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183084|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183085|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183086|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183087|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183088|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183089|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183090|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183091|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183092|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183093|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183094|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183095|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183096|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183097|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183098|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183099|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183100|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183101|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183102|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183103|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183306|NCT01245595|P2|Participant Flow|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
183104|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183105|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183106|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183107|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183108|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183109|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183110|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183111|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
183112|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183113|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183114|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183115|NCT01248364|E4|Reported Event|Healthy Subjects|Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
183116|NCT01248364|E3|Reported Event|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183117|NCT01248364|E2|Reported Event|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183118|NCT01248364|E1|Reported Event|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
183119|NCT01248221|B3|Baseline|Total|Total of all reporting groups
183120|NCT01248221|B2|Baseline|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183121|NCT01248221|B1|Baseline|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183122|NCT01248221|P2|Participant Flow|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183123|NCT01248221|P1|Participant Flow|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183124|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183125|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183157|NCT01248013|P1|Participant Flow|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
183126|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183127|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183128|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183129|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183130|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183131|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183132|NCT01248221|E2|Reported Event|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183133|NCT01248221|E1|Reported Event|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
183134|NCT01248130|B3|Baseline|Total|Total of all reporting groups
183135|NCT01248130|B2|Baseline|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183136|NCT01248130|B1|Baseline|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183137|NCT01248130|P2|Participant Flow|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183198|NCT01247285|B3|Baseline|Total|Total of all reporting groups
183477|NCT01246011|E3|Reported Event|Heparin PF4 Antibody Negative|
183138|NCT01248130|P1|Participant Flow|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183139|NCT01248130|O2|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183140|NCT01248130|O1|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183141|NCT01248130|E2|Reported Event|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183142|NCT01248130|E1|Reported Event|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
183143|NCT01248065|B3|Baseline|Total|Total of all reporting groups
183144|NCT01248065|B2|Baseline|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183145|NCT01248065|B1|Baseline|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183146|NCT01248065|P2|Participant Flow|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183147|NCT01248065|P1|Participant Flow|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183148|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183149|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183150|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183151|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183152|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183153|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183154|NCT01248065|E2|Reported Event|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
183155|NCT01248065|E1|Reported Event|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
183156|NCT01248013|B1|Baseline|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
183158|NCT01248013|O1|Outcome|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
183159|NCT01248013|E1|Reported Event|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
183160|NCT01247974|B3|Baseline|Total|Total of all reporting groups
183161|NCT01247974|B2|Baseline|Control|No closure of pericardium
183162|NCT01247974|B1|Baseline|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
183163|NCT01247974|P2|Participant Flow|Control|Pericardium is not closed
183164|NCT01247974|P1|Participant Flow|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
183165|NCT01247974|O2|Outcome|Control|No Pericardial Closure
183166|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
183167|NCT01247974|O2|Outcome|Control|No Pericardial Closure
183168|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
183169|NCT01247974|E2|Reported Event|Control|Pericardium is not closed
183170|NCT01247974|E1|Reported Event|CorMatrix ECM|CorMatrix ECM for Pericardial Closure
183171|NCT01247922|B1|Baseline|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183172|NCT01247922|P1|Participant Flow|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183173|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183174|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183175|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183176|NCT01247922|E1|Reported Event|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
183177|NCT01247428|B1|Baseline|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183178|NCT01247428|P1|Participant Flow|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183179|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183180|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183181|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183182|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183183|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183184|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183185|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183186|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183187|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183188|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183189|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183190|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183191|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183192|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183193|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183194|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183195|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183196|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183197|NCT01247428|E1|Reported Event|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
183199|NCT01247285|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183200|NCT01247285|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183201|NCT01247285|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183202|NCT01247285|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183203|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183204|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183205|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183206|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183207|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183208|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183209|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183210|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183211|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183212|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183213|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
183214|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183215|NCT01247285|E2|Reported Event|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in either period.
183216|NCT01247285|E1|Reported Event|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
183217|NCT01247272|B3|Baseline|Total|Total of all reporting groups
183218|NCT01247272|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183219|NCT01247272|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183220|NCT01247272|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183221|NCT01247272|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183222|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183223|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183224|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183225|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183226|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183227|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183228|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183229|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183230|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183231|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183232|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183233|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183234|NCT01247272|E2|Reported Event|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
183235|NCT01247272|E1|Reported Event|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
183238|NCT01247220|B1|Baseline|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183239|NCT01247220|P2|Participant Flow|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
183240|NCT01247220|P1|Participant Flow|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183241|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
183242|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183243|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
183244|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183245|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
183246|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183247|NCT01247220|E2|Reported Event|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
183248|NCT01247220|E1|Reported Event|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
183249|NCT01245751|B5|Baseline|Total|Total of all reporting groups
183250|NCT01245751|B4|Baseline|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183251|NCT01245751|B3|Baseline|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183252|NCT01245751|B2|Baseline|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183253|NCT01245751|B1|Baseline|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183254|NCT01245751|P4|Participant Flow|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183255|NCT01245751|P3|Participant Flow|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183256|NCT01245751|P2|Participant Flow|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183257|NCT01245751|P1|Participant Flow|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183258|NCT01245751|O4|Outcome|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183259|NCT01245751|O3|Outcome|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183260|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183261|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183262|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183263|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183264|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183265|NCT01245751|E4|Reported Event|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183266|NCT01245751|E3|Reported Event|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
204868|NCT01181011|E3|Reported Event|Amlodipine 5mg|
183267|NCT01245751|E2|Reported Event|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183268|NCT01245751|E1|Reported Event|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
183269|NCT01245738|B1|Baseline|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183270|NCT01245738|P1|Participant Flow|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183271|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183272|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183273|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183274|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183275|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183276|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183277|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183278|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183279|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183280|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183281|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183282|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183283|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183284|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183285|NCT01245738|E1|Reported Event|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
183286|NCT01245647|B3|Baseline|Total|Total of all reporting groups
183287|NCT01245647|B2|Baseline|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183288|NCT01245647|B1|Baseline|Sugar Pill, 50mg, Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183289|NCT01245647|P2|Participant Flow|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183290|NCT01245647|P1|Participant Flow|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183291|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183292|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183293|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183294|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183295|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183296|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183297|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183298|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183299|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183300|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183301|NCT01245647|E2|Reported Event|Naltrexone, 50mg Pill Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
183302|NCT01245647|E1|Reported Event|Sugar Pill, 50 mg Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
183303|NCT01245595|B3|Baseline|Total|Total of all reporting groups
204869|NCT01181011|E2|Reported Event|Telmisartan 80mg|
183307|NCT01245595|P1|Participant Flow|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
183308|NCT01245595|O2|Outcome|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
183309|NCT01245595|O1|Outcome|Aminophylline|"Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
183310|NCT01245595|E2|Reported Event|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
183311|NCT01245595|E1|Reported Event|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
183312|NCT01247090|B4|Baseline|Total|Total of all reporting groups
183313|NCT01247090|B3|Baseline|Placebo|No Dose - Placebo Comparator
183314|NCT01247090|B2|Baseline|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
183315|NCT01247090|B1|Baseline|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
183316|NCT01247090|P3|Participant Flow|Placebo|No Dose - Placebo Comparator
183317|NCT01247090|P2|Participant Flow|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
183318|NCT01247090|P1|Participant Flow|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
183319|NCT01247090|O3|Outcome|Placebo|No Dose - Placebo Comparator
183320|NCT01247090|O2|Outcome|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
183321|NCT01247090|O1|Outcome|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
183322|NCT01247090|E3|Reported Event|Placebo|No Dose - Placebo Comparator
183323|NCT01247090|E2|Reported Event|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
183324|NCT01247090|E1|Reported Event|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
183325|NCT01247064|B3|Baseline|Total|Total of all reporting groups
183326|NCT01247064|B2|Baseline|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183327|NCT01247064|B1|Baseline|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183328|NCT01247064|P2|Participant Flow|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183329|NCT01247064|P1|Participant Flow|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183330|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183331|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183332|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183333|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183334|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183335|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183336|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183337|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183338|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183339|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183340|NCT01247064|E2|Reported Event|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
183341|NCT01247064|E1|Reported Event|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
183342|NCT01246999|B5|Baseline|Total|Total of all reporting groups
183343|NCT01246999|B4|Baseline|LAIV - TIV|LAIV will be given followed by TIV 28 days later
183344|NCT01246999|B3|Baseline|TIV - TIV|TIV will be given followed by TIV 28 days later
183345|NCT01246999|B2|Baseline|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183346|NCT01246999|B1|Baseline|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183347|NCT01246999|P4|Participant Flow|TIV - TIV|TIV will be given IM followed by TIV IM
183348|NCT01246999|P3|Participant Flow|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183349|NCT01246999|P2|Participant Flow|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183350|NCT01246999|P1|Participant Flow|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183351|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183352|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183353|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183515|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
183354|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183355|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183356|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183357|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183358|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183359|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183360|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183361|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183362|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183363|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183364|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183365|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183366|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183367|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183368|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183369|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183370|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183371|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
183372|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
183373|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183374|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183375|NCT01246999|O3|Outcome|All First Dose Live Vaccine|All subjects who received LAIV as a first dose
183376|NCT01246999|O2|Outcome|Seasonal Influenza Vaccine (TIV-LAIV)|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183377|NCT01246999|O1|Outcome|Trivalent Seasonal Live Attenuated Influenza Vaccine|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183378|NCT01246999|E4|Reported Event|TIV-TIV|TIV will be given IM followed by IV IM
183379|NCT01246999|E3|Reported Event|LAIV-TIV|LAIV will be given intranasally followed by TIV intramuscularly
183380|NCT01246999|E2|Reported Event|TIV-LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
183381|NCT01246999|E1|Reported Event|LAIV-LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
183382|NCT01246973|B3|Baseline|Total|Total of all reporting groups
184004|NCT01244516|E2|Reported Event|Lotrafilcon B|lotrafilcon B, base curve 8.60
183383|NCT01246973|B2|Baseline|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
183384|NCT01246973|B1|Baseline|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
183385|NCT01246973|P2|Participant Flow|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
183386|NCT01246973|P1|Participant Flow|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
183387|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
183388|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
183389|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
183390|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
183391|NCT01246973|E2|Reported Event|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
183392|NCT01246973|E1|Reported Event|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
183393|NCT01246960|B3|Baseline|Total|Total of all reporting groups
183394|NCT01246960|B2|Baseline|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183395|NCT01246960|B1|Baseline|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183396|NCT01246960|P2|Participant Flow|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 mg/m^2~Leucovorin 400 mg/m^2~5-FU 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183397|NCT01246960|P1|Participant Flow|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 milligrams per square meter (mg/m^2)~Leucovorin 400 mg/m^2~5-Fluorouracil (5-FU) 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183398|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183399|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183400|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183478|NCT01246011|E2|Reported Event|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
183401|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183402|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183403|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183404|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183405|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183406|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183407|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183408|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183409|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183410|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183411|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183412|NCT01246960|E2|Reported Event|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183479|NCT01246011|E1|Reported Event|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
183480|NCT01245764|B5|Baseline|Total|Total of all reporting groups
183413|NCT01246960|E1|Reported Event|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
183414|NCT01246791|B1|Baseline|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183415|NCT01246791|P1|Participant Flow|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183416|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183417|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183418|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183419|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183420|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183421|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183422|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183423|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183424|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183425|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183426|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183427|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183428|NCT01246791|E1|Reported Event|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
183429|NCT01246713|B1|Baseline|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
183430|NCT01246713|P1|Participant Flow|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period. Whether they received the solid or liquid preparation initially was randomly chosen.
183431|NCT01246713|O2|Outcome|Acetaminophen Liquid Formulation|Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
183432|NCT01246713|O1|Outcome|Acetaminophen Solid Formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
183433|NCT01246713|E1|Reported Event|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
183434|NCT01246479|B1|Baseline|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
183435|NCT01246479|P1|Participant Flow|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
183436|NCT01246479|O1|Outcome|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
183437|NCT01246479|E1|Reported Event|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
183438|NCT01246349|B3|Baseline|Total|Total of all reporting groups
183439|NCT01246349|B2|Baseline|Control (Social Skills Training)|"The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.~The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients’ readiness to change was made in this group."
183516|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
183440|NCT01246349|B1|Baseline|Treatment Group (Motivational Interviewing)|"The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client’s intrinsic motivation to change by exploring and resolving ambivalence.~MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.~Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student."
183441|NCT01246349|P2|Participant Flow|Treatment/Experimental Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183442|NCT01246349|P1|Participant Flow|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183443|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183444|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183445|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183446|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183447|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183448|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183449|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183481|NCT01245764|B4|Baseline|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
184005|NCT01244516|E1|Reported Event|Galyfilcon A|galyfilcon A base curve 8.30
183450|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183451|NCT01246349|E2|Reported Event|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
183452|NCT01246349|E1|Reported Event|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
183453|NCT01246258|B1|Baseline|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
183454|NCT01246258|P1|Participant Flow|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
183455|NCT01246258|O1|Outcome|Test Group|"Standard tests of balance function~Vestibular evoked myogenic potentials (VEMPs): Standard test of balance function~Utricular centrifugation test: Standard test of balance function"
183456|NCT01246258|O1|Outcome|Test Group|VEMPs
183457|NCT01246258|E1|Reported Event|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
183458|NCT01246076|B1|Baseline|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183459|NCT01246076|P1|Participant Flow|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183460|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183461|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183462|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183463|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183464|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183465|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183466|NCT01246076|E1|Reported Event|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
183467|NCT01246011|B4|Baseline|Total|Total of all reporting groups
183468|NCT01246011|B3|Baseline|Heparin PF4 Antibody Negative|
183469|NCT01246011|B2|Baseline|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
183470|NCT01246011|B1|Baseline|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
183471|NCT01246011|P3|Participant Flow|Heparin PF4 Antibody Negative|
183472|NCT01246011|P2|Participant Flow|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
183473|NCT01246011|P1|Participant Flow|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
183474|NCT01246011|O3|Outcome|Heparin PF4 Antibody Negative|
183475|NCT01246011|O2|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
183476|NCT01246011|O1|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
183482|NCT01245764|B3|Baseline|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183483|NCT01245764|B2|Baseline|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183484|NCT01245764|B1|Baseline|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183485|NCT01245764|P4|Participant Flow|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
183486|NCT01245764|P3|Participant Flow|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183487|NCT01245764|P2|Participant Flow|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183488|NCT01245764|P1|Participant Flow|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183489|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183490|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183491|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183492|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183493|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183494|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183495|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
183496|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
183497|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
183498|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183499|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183500|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
183501|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183502|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183503|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183504|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183505|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183506|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183507|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183508|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183509|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183510|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183511|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183512|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183513|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
183517|NCT01245764|E4|Reported Event|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
183518|NCT01245764|E3|Reported Event|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
183519|NCT01245764|E2|Reported Event|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
183520|NCT01245764|E1|Reported Event|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
183521|NCT01245439|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183522|NCT01245439|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183523|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183524|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183525|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183526|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183527|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183528|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183529|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183530|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183531|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183532|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183533|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183534|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183535|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183536|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
184056|NCT01244490|O1|Outcome|Placebo|Once daily
183537|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183538|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183539|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183540|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183541|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current (DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183542|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183543|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183544|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183545|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183546|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183547|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183548|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183549|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183550|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183551|NCT01245439|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
183552|NCT01245413|B1|Baseline|Entire Study Population|Entire study population = all participlants enrolled in the study
183553|NCT01245413|P2|Participant Flow|Athena Adhesive|Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
183554|NCT01245413|P1|Participant Flow|SenSura Adhesive|Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
183555|NCT01245413|O2|Outcome|Athena Adhesive|New test adhesive
183556|NCT01245413|O1|Outcome|SenSura Adhesive|Reference adhesive which is commercially available.
183557|NCT01245413|E2|Reported Event|Athena Adhesive|Base-plate adhesion to skin
183558|NCT01245413|E1|Reported Event|SenSura Adhesive|base-plate adhesion to skin
183559|NCT01245387|B1|Baseline|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183761|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183560|NCT01245387|P1|Participant Flow|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183561|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183562|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183563|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183564|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183565|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183566|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183567|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183568|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183569|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183570|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183571|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183572|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183573|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183574|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183575|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183576|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183577|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183578|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183579|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183580|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183581|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183582|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183583|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183584|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183585|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
184260|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
183586|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183587|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183588|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183589|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183590|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183591|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183592|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183593|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183594|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183595|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183596|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183597|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183598|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183599|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183600|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183601|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183602|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183603|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183604|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183605|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183606|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183607|NCT01245387|E1|Reported Event|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
183608|NCT01245374|B1|Baseline|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183609|NCT01245374|P1|Participant Flow|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183610|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183611|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183797|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183612|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183613|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183614|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183615|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183616|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183617|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183618|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183619|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183620|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183621|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183622|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183623|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
183624|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183625|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183626|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183627|NCT01245374|E1|Reported Event|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
183628|NCT01245283|B4|Baseline|Total|Total of all reporting groups
183629|NCT01245283|B3|Baseline|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183630|NCT01245283|B2|Baseline|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183631|NCT01245283|B1|Baseline|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
183632|NCT01245283|P3|Participant Flow|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183633|NCT01245283|P2|Participant Flow|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183634|NCT01245283|P1|Participant Flow|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
183891|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183635|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183636|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183637|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183638|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183639|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183640|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183641|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183642|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183643|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183644|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183645|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183646|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183647|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183648|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183649|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183650|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183651|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183652|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183653|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183654|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183655|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183656|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183657|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
183658|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
183722|NCT01245062|E1|Reported Event|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183659|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183660|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183661|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
183662|NCT01245283|E3|Reported Event|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183663|NCT01245283|E2|Reported Event|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
183664|NCT01245283|E1|Reported Event|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
183665|NCT01245270|B3|Baseline|Total|Total of all reporting groups
183666|NCT01245270|B2|Baseline|Control Capsule First, Then Bilberry Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183667|NCT01245270|B1|Baseline|Bilberry Capsule First, Then Control Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183668|NCT01245270|P2|Participant Flow|Single Bilberry Capsule First Then Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183669|NCT01245270|P1|Participant Flow|Single Control Capsule First Then Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183723|NCT01244984|B4|Baseline|Total|Total of all reporting groups
183724|NCT01244984|B3|Baseline|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183892|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183670|NCT01245270|O2|Outcome|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183671|NCT01245270|O1|Outcome|Single Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183672|NCT01245270|O2|Outcome|Single Blaeberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183673|NCT01245270|O1|Outcome|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183674|NCT01245270|E2|Reported Event|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183675|NCT01245270|E1|Reported Event|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
183676|NCT01245101|B3|Baseline|Total|Total of all reporting groups
183677|NCT01245101|B2|Baseline|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
183678|NCT01245101|B1|Baseline|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
183679|NCT01245101|P2|Participant Flow|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
183680|NCT01245101|P1|Participant Flow|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
183681|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
183682|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
183683|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
183684|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
183685|NCT01245101|E2|Reported Event|Observation|Observation for 16 weeks
183686|NCT01245101|E1|Reported Event|Raltegravir|Raltegravir 400 mg twice a day for 16 weeks
183687|NCT01245062|B3|Baseline|Total|Total of all reporting groups
183688|NCT01245062|B2|Baseline|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183689|NCT01245062|B1|Baseline|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183690|NCT01245062|P3|Participant Flow|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
183691|NCT01245062|P2|Participant Flow|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183692|NCT01245062|P1|Participant Flow|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183693|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
183694|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
183695|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183696|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183697|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183698|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183699|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
183700|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183701|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183702|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183703|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183704|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183705|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183706|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183707|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183708|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183709|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183710|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183711|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183712|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183713|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183714|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183715|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183716|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183717|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183718|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183719|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
183720|NCT01245062|E3|Reported Event|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
183721|NCT01245062|E2|Reported Event|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
183725|NCT01244984|B2|Baseline|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183949|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183726|NCT01244984|B1|Baseline|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183727|NCT01244984|P3|Participant Flow|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183728|NCT01244984|P2|Participant Flow|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183729|NCT01244984|P1|Participant Flow|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183730|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183731|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183732|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183733|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183734|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183735|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183736|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183737|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183738|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183739|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183740|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183741|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183742|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183743|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183744|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183745|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183746|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183747|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183748|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183749|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183750|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183751|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183752|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183753|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183754|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183755|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183756|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183757|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183758|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183759|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183760|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
184262|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
183762|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183763|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183764|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183765|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183766|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183767|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183768|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183769|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183770|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183771|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183772|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183773|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183774|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183775|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183776|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183777|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183778|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183779|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183780|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183781|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183782|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183783|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183784|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183785|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183786|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183787|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183788|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183789|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183790|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183791|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183792|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183793|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183794|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183795|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183796|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183989|NCT01244516|B3|Baseline|BIO (Biofinity)|Subjects that were randomized to wear Biofinity lens throughout the course of the study.
183798|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183799|NCT01244984|E3|Reported Event|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
183800|NCT01244984|E2|Reported Event|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
183801|NCT01244984|E1|Reported Event|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
183802|NCT01244906|B1|Baseline|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183803|NCT01244906|P1|Participant Flow|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183804|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183805|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183806|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183807|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183808|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183809|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183810|NCT01244906|E1|Reported Event|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
183811|NCT01244893|B1|Baseline|All Subjects|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
183990|NCT01244516|B2|Baseline|AOA (Air Optic)|Subjects that were randomized to wear AOA lens throughout the course of the study.
183812|NCT01244893|P2|Participant Flow|Acuvue Advance Plus postQ/Acuvue Advance Plus preQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second."
183813|NCT01244893|P1|Participant Flow|Acuvue Advance Plus preQ/Acuvue Advance Plus postQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second."
183814|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.
183815|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.
183816|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.
183817|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
183818|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.
183819|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
183820|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
183821|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.
183822|NCT01244893|E2|Reported Event|AAP PostQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
183823|NCT01244893|E1|Reported Event|AAP PreQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
183824|NCT01244828|B1|Baseline|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183825|NCT01244828|P1|Participant Flow|Asenapine|All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183826|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183827|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183828|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183829|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183830|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183831|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183832|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183947|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183833|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183834|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183835|NCT01244828|E1|Reported Event|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
183836|NCT01244815|B5|Baseline|Total|Total of all reporting groups
183837|NCT01244815|B4|Baseline|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183838|NCT01244815|B3|Baseline|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183839|NCT01244815|B2|Baseline|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183840|NCT01244815|B1|Baseline|Placebo|Participants receive placebo BID for 21 days.
183841|NCT01244815|P4|Participant Flow|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183842|NCT01244815|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183843|NCT01244815|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183844|NCT01244815|P1|Participant Flow|Placebo|Participants receive placebo twice daily (BID) for 21 days.
183845|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183846|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183847|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183848|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183849|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183850|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183851|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183852|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183853|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183854|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183855|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183856|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183857|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183858|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183859|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183860|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183991|NCT01244516|B1|Baseline|AAHP (Acuvue)|Subjects that were randomized to wear AAHP lens throughout the course of the study.
183861|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183862|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183863|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183864|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183865|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183866|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183867|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183868|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183869|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183870|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183871|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183872|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183873|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183874|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183875|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183876|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183877|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183878|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183879|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183880|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183881|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183882|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183883|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183884|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183885|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183886|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183887|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183888|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183889|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183890|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183893|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183894|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183895|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183896|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183897|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183898|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183899|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183900|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183901|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183902|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183903|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183904|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183905|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183906|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183907|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183908|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183909|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183910|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183911|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183912|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
183913|NCT01244815|E4|Reported Event|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
183914|NCT01244815|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
183915|NCT01244815|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
183916|NCT01244815|E1|Reported Event|Placebo|Participants receive placebo BID for 21 days.
183917|NCT01244724|B1|Baseline|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
183918|NCT01244724|P1|Participant Flow|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
183919|NCT01244724|O1|Outcome|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
183920|NCT01244724|E1|Reported Event|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
183948|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183921|NCT01244711|B1|Baseline|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
183922|NCT01244711|P1|Participant Flow|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
183923|NCT01244711|O1|Outcome|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
183924|NCT01244711|E1|Reported Event|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
183925|NCT01244633|B1|Baseline|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
183926|NCT01244633|P1|Participant Flow|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
183927|NCT01244633|O1|Outcome|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
183928|NCT01244633|E1|Reported Event|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
183929|NCT01244620|B1|Baseline|Entire Study Population|All randomized participants
183930|NCT01244620|P4|Participant Flow|Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
183931|NCT01244620|P3|Participant Flow|Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
183932|NCT01244620|P2|Participant Flow|Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad|Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
183933|NCT01244620|P1|Participant Flow|Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild|Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.
183934|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183935|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183936|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183937|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183938|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183939|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183940|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183941|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183942|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183943|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183944|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183945|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183946|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
204870|NCT01181011|E1|Reported Event|Telmisartan 80mg, Amlodipine 5mg|
183950|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183951|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183952|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183953|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183954|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183955|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183956|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183957|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183958|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183959|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183960|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183961|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
183962|NCT01244620|E4|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days
183963|NCT01244620|E3|Reported Event|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days
183964|NCT01244620|E2|Reported Event|Tadalafil|Tadalafil 40 mg tablet QD for 6 days
183965|NCT01244620|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days
183966|NCT01244529|B1|Baseline|All Subjects|All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
183967|NCT01244529|P1|Participant Flow|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
183968|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183969|NCT01244529|O3|Outcome|Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183970|NCT01244529|O2|Outcome|Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183971|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183972|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183973|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183974|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183975|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183976|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183977|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183978|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183979|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183980|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183981|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183982|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183983|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183984|NCT01244529|O3|Outcome|Senofilcon A|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183985|NCT01244529|O2|Outcome|Galyfilcon A (Control)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183986|NCT01244529|O1|Outcome|Galyfilcon A Plus (Test)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
183987|NCT01244529|E1|Reported Event|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
183988|NCT01244516|B4|Baseline|Total|Total of all reporting groups
184006|NCT01244503|B1|Baseline|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
184007|NCT01244503|P1|Participant Flow|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
184008|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
184009|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
184010|NCT01244503|E1|Reported Event|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
184011|NCT01244490|B4|Baseline|Total|Total of all reporting groups
184012|NCT01244490|B3|Baseline|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184013|NCT01244490|B2|Baseline|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184014|NCT01244490|B1|Baseline|Placebo|Once daily
184015|NCT01244490|P3|Participant Flow|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184016|NCT01244490|P2|Participant Flow|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184017|NCT01244490|P1|Participant Flow|Placebo|Once daily
184018|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184019|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184020|NCT01244490|O1|Outcome|Placebo|Once daily
184021|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184022|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184023|NCT01244490|O1|Outcome|Placebo|Once daily
184024|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184025|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184026|NCT01244490|O1|Outcome|Placebo|Once daily
184027|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184028|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184029|NCT01244490|O1|Outcome|Placebo|Once daily
184030|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184031|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184032|NCT01244490|O1|Outcome|Placebo|Once daily
184033|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184034|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184035|NCT01244490|O1|Outcome|Placebo|Once daily
184036|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184037|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184038|NCT01244490|O1|Outcome|Placebo|Once daily
184039|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184040|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184041|NCT01244490|O1|Outcome|Placebo|Once daily
184042|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184043|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184044|NCT01244490|O1|Outcome|Placebo|Once daily
184045|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184046|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184047|NCT01244490|O1|Outcome|Placebo|Once daily
184048|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184049|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184050|NCT01244490|O1|Outcome|Placebo|Once daily
184051|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184052|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184053|NCT01244490|O1|Outcome|Placebo|Once daily
184054|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184055|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184057|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184058|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184059|NCT01244490|O1|Outcome|Placebo|Once daily
184060|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184061|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184062|NCT01244490|O1|Outcome|Placebo|Once daily
184063|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184064|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184065|NCT01244490|O1|Outcome|Placebo|Once daily
184066|NCT01244490|E3|Reported Event|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
184067|NCT01244490|E2|Reported Event|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
184068|NCT01244490|E1|Reported Event|Placebo|Once daily
184069|NCT01244477|B3|Baseline|Total|Total of all reporting groups
184070|NCT01244477|B2|Baseline|Arm 2|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
184071|NCT01244477|B1|Baseline|Arm 1|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
184072|NCT01244477|P2|Participant Flow|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
184073|NCT01244477|P1|Participant Flow|CPT-C|Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
184074|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
184075|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
184076|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
184077|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
184078|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
184079|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
184080|NCT01244477|E2|Reported Event|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
184081|NCT01244477|E1|Reported Event|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
184082|NCT01244425|B3|Baseline|Total|Total of all reporting groups
184083|NCT01244425|B2|Baseline|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
184084|NCT01244425|B1|Baseline|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
184085|NCT01244425|P2|Participant Flow|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
184086|NCT01244425|P1|Participant Flow|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
184087|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
184088|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
184089|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
184090|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
184091|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
184092|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
184093|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
184094|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
184095|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
184096|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.
184261|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184097|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
184098|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.
184099|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
184100|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.
184101|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
184102|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.
184103|NCT01244425|E2|Reported Event|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
184104|NCT01244425|E1|Reported Event|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
184105|NCT01244412|B1|Baseline|Imaged Subjects|
184106|NCT01244412|P1|Participant Flow|Imaged Subjects|Subjects imaged with hand held device
184107|NCT01244412|O1|Outcome|Imaged Subjects|
184108|NCT01244412|E1|Reported Event|Imaged Subjects|
184109|NCT01244243|B1|Baseline|Active Therapy|"All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.~Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks."
184110|NCT01244243|P1|Participant Flow|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
184111|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
184112|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
184113|NCT01244243|E1|Reported Event|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
184114|NCT01244126|B4|Baseline|Total|Total of all reporting groups
184115|NCT01244126|B3|Baseline|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
184116|NCT01244126|B2|Baseline|IV Morphine|0.1 mg/kg morphine IV
184117|NCT01244126|B1|Baseline|IM Morphine|0.1 mg/kg morphine IM
184118|NCT01244126|P3|Participant Flow|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
184119|NCT01244126|P2|Participant Flow|IV Morphine|0.1 mg/kg morphine IV
184120|NCT01244126|P1|Participant Flow|IM Morphine|0.1 mg/kg morphine IM
184121|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
184122|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
184123|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
184124|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
184125|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
184126|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
184127|NCT01244126|E3|Reported Event|IV Morphine|0.1 mg/kg morphine IV
184128|NCT01244126|E2|Reported Event|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
184129|NCT01244126|E1|Reported Event|IM Morphine|0.1 mg/kg morphine IM
184130|NCT01244061|B3|Baseline|Total|Total of all reporting groups
184131|NCT01244061|B2|Baseline|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184132|NCT01244061|B1|Baseline|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184133|NCT01244061|P2|Participant Flow|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184134|NCT01244061|P1|Participant Flow|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184135|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184136|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184137|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184138|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184139|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184140|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184141|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184142|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184143|NCT01244061|E2|Reported Event|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
184144|NCT01244061|E1|Reported Event|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
184145|NCT01243944|B3|Baseline|Total|Total of all reporting groups
184146|NCT01243944|B2|Baseline|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184147|NCT01243944|B1|Baseline|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184148|NCT01243944|P2|Participant Flow|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184149|NCT01243944|P1|Participant Flow|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
184150|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184151|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184152|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184153|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184154|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184155|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184156|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184157|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184158|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184159|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184160|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184161|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184162|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184163|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184164|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184165|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184166|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184167|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184168|NCT01243944|E2|Reported Event|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
184169|NCT01243944|E1|Reported Event|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
184170|NCT01243892|B3|Baseline|Total|Total of all reporting groups
184171|NCT01243892|B2|Baseline|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184172|NCT01243892|B1|Baseline|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184173|NCT01243892|P2|Participant Flow|ISS Participants|Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184174|NCT01243892|P1|Participant Flow|IGHD Participants|Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184175|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184176|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184177|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184178|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184179|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184180|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184181|NCT01243892|E2|Reported Event|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184182|NCT01243892|E1|Reported Event|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
184183|NCT01243775|B1|Baseline|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
184184|NCT01243775|P1|Participant Flow|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
184185|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
184186|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
184187|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
184188|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
184189|NCT01243775|E1|Reported Event|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
184190|NCT01243671|B1|Baseline|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184191|NCT01243671|P1|Participant Flow|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184192|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184193|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184194|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184195|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184196|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184197|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184198|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184199|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184200|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184201|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184202|NCT01243671|E1|Reported Event|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
184203|NCT01243619|B1|Baseline|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
184204|NCT01243619|P1|Participant Flow|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
184205|NCT01243619|O1|Outcome|All Participants|"All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.~All patients accepted and complied with having three sets of PET scans performed (six total PET scans).~The software used in this protocol has allowed quantitative comparison among the PET scans."
184206|NCT01243619|E1|Reported Event|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
184207|NCT01243567|B3|Baseline|Total|Total of all reporting groups
184208|NCT01243567|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184209|NCT01243567|B1|Baseline|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184210|NCT01243567|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184211|NCT01243567|P1|Participant Flow|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184212|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184213|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184214|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184215|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184216|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184217|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184218|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184219|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184220|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184221|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184222|NCT01243567|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184223|NCT01243567|E1|Reported Event|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
184224|NCT01243450|B4|Baseline|Total|Total of all reporting groups
184225|NCT01243450|B3|Baseline|Placebo|Placebo group
184226|NCT01243450|B2|Baseline|Brand|Brand group
184227|NCT01243450|B1|Baseline|Active Generic|Active generic group
184228|NCT01243450|P3|Participant Flow|Brand|Tretinoin: Topical skin
184229|NCT01243450|P2|Participant Flow|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
184230|NCT01243450|P1|Participant Flow|Active Generic|"active cream~Tretinoin: Topical skin"
184231|NCT01243450|O3|Outcome|Brand|Tretinoin: Topical skin
184232|NCT01243450|O2|Outcome|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
184233|NCT01243450|O1|Outcome|Active Generic|"active cream~Tretinoin: Topical skin"
184234|NCT01243450|E3|Reported Event|Brand|Tretinoin: Topical skin
184235|NCT01243450|E2|Reported Event|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
184236|NCT01243450|E1|Reported Event|Active Generic|"active cream~Tretinoin: Topical skin"
184237|NCT01243411|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184238|NCT01243411|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184239|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184240|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184241|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184242|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184243|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184244|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184245|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184246|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184247|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184248|NCT01243411|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
184249|NCT01243320|B1|Baseline|All Study Participants|10 ppm Silver, then 32 ppm Silver
184250|NCT01243320|P1|Participant Flow|All Study Participants|Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.
184251|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184252|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184253|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184254|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184255|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184256|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184257|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184258|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184259|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184263|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184264|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184265|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184266|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184267|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184268|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184269|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184270|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184271|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184272|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184273|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184274|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184275|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184276|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184277|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184278|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184279|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184280|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184281|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184282|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184283|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184284|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184285|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184286|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184287|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184288|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184289|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184290|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184291|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184292|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184293|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184294|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184295|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184296|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184297|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184298|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184299|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184300|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184301|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184302|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184303|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184304|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184305|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184306|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184307|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184308|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184309|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184310|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184311|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184312|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184313|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184314|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184315|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184316|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184317|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184318|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184319|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184320|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184321|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
184322|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
184323|NCT01243320|E2|Reported Event|32ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
184324|NCT01243320|E1|Reported Event|10ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
184325|NCT01243294|B1|Baseline|Entire Study Population|Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
184326|NCT01243294|P2|Participant Flow|SS First, Then SenSura|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184327|NCT01243294|P1|Participant Flow|SenSura First, Then SS|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184328|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184329|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184330|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184331|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184332|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184333|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184334|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184335|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184336|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184337|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184338|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184476|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
184339|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
184340|NCT01243294|E2|Reported Event|SS (New Ostomy Bag)|Base plates applied 1 till 6 times a day SS = new ostomy bag
184341|NCT01243294|E1|Reported Event|SenSura|Base plates applied 1 till 6 times a day
184342|NCT01243242|B3|Baseline|Total|Total of all reporting groups
184343|NCT01243242|B2|Baseline|Placebo|Eligible subjects who received 1400 mg of Placebo
184344|NCT01243242|B1|Baseline|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184345|NCT01243242|P2|Participant Flow|Placebo|Eligible subjects who received 1400 mg of Placebo
184346|NCT01243242|P1|Participant Flow|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184347|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
184348|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184349|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
184350|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184351|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
184352|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184353|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
184354|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184355|NCT01243242|E2|Reported Event|Placebo|Eligible subjects who received 1400 mg of Placebo
184356|NCT01243242|E1|Reported Event|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
184357|NCT01243177|B3|Baseline|Total Title|
184358|NCT01243177|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184359|NCT01243177|B1|Baseline|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184360|NCT01243177|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184361|NCT01243177|P1|Participant Flow|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184362|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184363|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184364|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184365|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184366|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184367|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184368|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184369|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184370|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184371|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184372|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184373|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184374|NCT01243177|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
184375|NCT01243177|E1|Reported Event|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
184376|NCT01243112|B1|Baseline|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
184377|NCT01243112|P1|Participant Flow|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
184378|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
184379|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
184380|NCT01243112|E1|Reported Event|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
184381|NCT01242813|B1|Baseline|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184382|NCT01242813|P1|Participant Flow|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
184383|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184384|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184385|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184386|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184387|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184388|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184389|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184390|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184391|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184392|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184393|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184394|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184477|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
184780|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184395|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184396|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184397|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184398|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184399|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184400|NCT01242813|E1|Reported Event|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
184401|NCT01242748|B3|Baseline|Total|Total of all reporting groups
184402|NCT01242748|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184403|NCT01242748|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184404|NCT01242748|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184405|NCT01242748|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184406|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184407|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184408|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184409|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184478|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
184479|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
184410|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184411|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184412|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184413|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184414|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184415|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184416|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184417|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184418|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184419|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184420|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184421|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184480|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
184781|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184422|NCT01242748|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
184423|NCT01242748|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
184424|NCT01242527|B5|Baseline|Total|Total of all reporting groups
184425|NCT01242527|B4|Baseline|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
184426|NCT01242527|B3|Baseline|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
184427|NCT01242527|B2|Baseline|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
184428|NCT01242527|B1|Baseline|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
184429|NCT01242527|P4|Participant Flow|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
184430|NCT01242527|P3|Participant Flow|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
184431|NCT01242527|P2|Participant Flow|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
184432|NCT01242527|P1|Participant Flow|Olive Oil (Placebo Control)|placebo : 4 capsules (1g) daily for 12 weeks
184433|NCT01242527|O4|Outcome|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
184434|NCT01242527|O3|Outcome|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
184435|NCT01242527|O2|Outcome|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
184436|NCT01242527|O1|Outcome|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
184437|NCT01242527|E4|Reported Event|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
184438|NCT01242527|E3|Reported Event|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
184439|NCT01242527|E2|Reported Event|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
184440|NCT01242527|E1|Reported Event|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
184441|NCT01242514|B4|Baseline|Total|Total of all reporting groups
184442|NCT01242514|B3|Baseline|Fostamatinib 100 mg qd|Oral treatment
184443|NCT01242514|B2|Baseline|Fostamatinib 150 mg qd|Oral treatment
184444|NCT01242514|B1|Baseline|Fostamatinib 100 mg Bid|Oral treatment
184445|NCT01242514|P3|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
184446|NCT01242514|P2|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
184447|NCT01242514|P1|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
184448|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
184449|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
184450|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
184451|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
184452|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
184453|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
184454|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
184455|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
184456|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
184457|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
184458|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
184459|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
184460|NCT01242514|E3|Reported Event|FOSTA 150 MG QD|
184461|NCT01242514|E2|Reported Event|FOSTA 100 MG QD|
184462|NCT01242514|E1|Reported Event|FOSTA 100 MG BID|
184463|NCT01242371|B3|Baseline|Total|Total of all reporting groups
184464|NCT01242371|B2|Baseline|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
184465|NCT01242371|B1|Baseline|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
184466|NCT01242371|P2|Participant Flow|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
184467|NCT01242371|P1|Participant Flow|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
184468|NCT01242371|O2|Outcome|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
184469|NCT01242371|O1|Outcome|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
184470|NCT01242371|E2|Reported Event|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
184471|NCT01242371|E1|Reported Event|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
184472|NCT01242176|B1|Baseline|Study Overall|"An open-label, randomised, two-way crossover study. The two treatments administered were~A single dose of empagliflozin (empa) 25mg, final formulation~A single dose of empa 25mg, trial formulation 2~Between drug administrations there was a washout period of at least 7 days."
184473|NCT01242176|P2|Participant Flow|Empa TF2 / Empa FF|Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
184474|NCT01242176|P1|Participant Flow|Empa FF / Empa TF2|Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
184475|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
184839|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184481|NCT01242176|E2|Reported Event|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
184482|NCT01242176|E1|Reported Event|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
184483|NCT01242111|B1|Baseline|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184484|NCT01242111|P1|Participant Flow|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184485|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184486|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184487|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184488|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184489|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184490|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184491|NCT01242111|E1|Reported Event|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
184492|NCT01242085|B4|Baseline|Total|Total of all reporting groups
184493|NCT01242085|B3|Baseline|Both Interventions|one participant had bilateral knee replacement with one control knee and one trumatch knee
184494|NCT01242085|B2|Baseline|Trumatch Group|patients randomized to study instrumentation
184495|NCT01242085|B1|Baseline|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
184496|NCT01242085|P3|Participant Flow|Both Interventions|one participant had both interventions - one for each knee
184497|NCT01242085|P2|Participant Flow|Control Group|control group will have standard instrumentation of their knee replacement
184498|NCT01242085|P1|Participant Flow|Trumatch Group|trumatch group will have customized knee instruments : CT based customized knee instruments
184499|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
184500|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
184501|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
184502|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
184503|NCT01242085|E2|Reported Event|Trumatch Group|patients randomized to study instrumentation
184504|NCT01242085|E1|Reported Event|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
184505|NCT01241916|B3|Baseline|Total|Total of all reporting groups
184506|NCT01241916|B2|Baseline|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
184507|NCT01241916|B1|Baseline|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
184508|NCT01241916|P2|Participant Flow|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
184509|NCT01241916|P1|Participant Flow|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
184510|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
184511|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
184512|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
184513|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
184514|NCT01241916|E2|Reported Event|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
184515|NCT01241916|E1|Reported Event|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
184516|NCT01241903|B3|Baseline|Total|Total of all reporting groups
184517|NCT01241903|B2|Baseline|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
184518|NCT01241903|B1|Baseline|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
184519|NCT01241903|P2|Participant Flow|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
184520|NCT01241903|P1|Participant Flow|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
184521|NCT01241903|O2|Outcome|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
184522|NCT01241903|O1|Outcome|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
184523|NCT01241903|E2|Reported Event|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
184524|NCT01241903|E1|Reported Event|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
184525|NCT01241760|B3|Baseline|Total|Total of all reporting groups
184526|NCT01241760|B2|Baseline|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184527|NCT01241760|B1|Baseline|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184528|NCT01241760|P2|Participant Flow|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184529|NCT01241760|P1|Participant Flow|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184530|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184531|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184532|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184533|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184534|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184535|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184536|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184537|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184538|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184539|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184540|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184778|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184779|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184541|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184542|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184543|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184544|NCT01241760|E3|Reported Event|Total|All
184545|NCT01241760|E2|Reported Event|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184546|NCT01241760|E1|Reported Event|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
184547|NCT01241591|B5|Baseline|Total|Total of all reporting groups
184548|NCT01241591|B4|Baseline|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184549|NCT01241591|B3|Baseline|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184550|NCT01241591|B2|Baseline|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184551|NCT01241591|B1|Baseline|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184552|NCT01241591|P4|Participant Flow|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184553|NCT01241591|P3|Participant Flow|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184554|NCT01241591|P2|Participant Flow|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184555|NCT01241591|P1|Participant Flow|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184556|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184557|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184558|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184559|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184560|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184561|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184562|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184563|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184564|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184565|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184566|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184567|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
204871|NCT01180998|B4|Baseline|Total|Total of all reporting groups
184568|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184569|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184570|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184571|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184572|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184573|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184574|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184575|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184576|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184577|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184578|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184579|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184580|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184581|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184582|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184583|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184584|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184585|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184586|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184587|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184588|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184589|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184590|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184591|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184592|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184593|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184594|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184595|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184840|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184596|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184597|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184598|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184599|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184600|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184601|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184602|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184603|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184604|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184605|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184606|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184607|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184608|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184609|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184610|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184611|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184612|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184613|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184614|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184615|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184616|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184617|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184618|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184619|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184620|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184621|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184622|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184623|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184841|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184624|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184625|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184626|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184627|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184628|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184629|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184630|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184631|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184632|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184633|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184634|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184635|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184636|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184637|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184638|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184639|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184640|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184641|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184642|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184643|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184644|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184645|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184646|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184647|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184648|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184649|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184650|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184651|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184842|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184652|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184653|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184654|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184655|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184656|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184657|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184658|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184659|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184660|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184661|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184662|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184663|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184664|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184665|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184666|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184667|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184668|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184669|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184670|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184671|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184672|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184673|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184674|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184675|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184676|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184677|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184678|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184679|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184843|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184680|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184681|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184682|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184683|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184684|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184685|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184686|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184687|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184688|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184689|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184690|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184691|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184692|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184693|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184694|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184695|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184696|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184697|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184698|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184699|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184700|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184701|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184702|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184703|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184704|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184705|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184706|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184707|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184844|NCT01241539|E1|Reported Event|Dabigatran|Dabigatran treated patients
184708|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184709|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184710|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184711|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184712|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184713|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184714|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184715|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184716|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184717|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184718|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184719|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184720|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184721|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184722|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184723|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184724|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184725|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184726|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184727|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184728|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184729|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184730|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184731|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184732|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184733|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184734|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184735|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184845|NCT01241513|B3|Baseline|Total|Total of all reporting groups
184736|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184737|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184738|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184739|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184740|NCT01241591|E4|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184741|NCT01241591|E3|Reported Event|Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184742|NCT01241591|E2|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184743|NCT01241591|E1|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
184744|NCT01241565|B1|Baseline|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
184745|NCT01241565|P1|Participant Flow|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
184746|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
184747|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
184748|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
184749|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
184750|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
184751|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
184752|NCT01241565|E1|Reported Event|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
184753|NCT01241552|B5|Baseline|Total|Total of all reporting groups
184754|NCT01241552|B4|Baseline|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184755|NCT01241552|B3|Baseline|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184756|NCT01241552|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184757|NCT01241552|B1|Baseline|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184758|NCT01241552|P4|Participant Flow|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184759|NCT01241552|P3|Participant Flow|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184760|NCT01241552|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184761|NCT01241552|P1|Participant Flow|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
184762|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184763|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184764|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184765|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184766|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184767|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184768|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184769|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184770|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184771|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184772|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184773|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184774|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184775|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184776|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184777|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184782|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184783|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184784|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184785|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184786|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184787|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184788|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184789|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184790|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184791|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184792|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184793|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184794|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184795|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184796|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184797|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184798|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184799|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184800|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184801|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184802|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184803|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184804|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184805|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184806|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184807|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184808|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184809|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184810|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184811|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184812|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184813|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184814|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184815|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184816|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184817|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184818|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
184819|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
184820|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
184821|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
184822|NCT01241552|E4|Reported Event|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + SOC for CDI
184823|NCT01241552|E3|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
184824|NCT01241552|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
184825|NCT01241552|E1|Reported Event|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI
184826|NCT01241539|B1|Baseline|Dabigatran|Dabigatran treated patients
184827|NCT01241539|P1|Participant Flow|Dabigatran|Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
184828|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
184829|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
184830|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184831|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184832|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184833|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184834|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184835|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184836|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184837|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
184838|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
184850|NCT01241513|O2|Outcome|NAC Group|N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
184851|NCT01241513|O1|Outcome|Placebo Group|Placebo (Diet soda only)
184852|NCT01241513|E1|Reported Event|NAC Group and Placebo Group|
184853|NCT01241292|B3|Baseline|Total|Total of all reporting groups
184854|NCT01241292|B2|Baseline|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184855|NCT01241292|B1|Baseline|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184856|NCT01241292|P2|Participant Flow|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184857|NCT01241292|P1|Participant Flow|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184858|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184859|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184860|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184869|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184861|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184862|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184863|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184864|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184865|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184866|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184867|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184868|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184883|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
184884|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
184885|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
184886|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
184887|NCT01241279|E2|Reported Event|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
184888|NCT01241279|E1|Reported Event|Crystalens AO|A silicone multi-piece accommodating intraocular lens
184870|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184871|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184872|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184873|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184874|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:~28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184875|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:~28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
184876|NCT01241292|E2|Reported Event|Elotuzumab 20mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184877|NCT01241292|E1|Reported Event|Elotuzumab 10mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
184878|NCT01241279|B3|Baseline|Total|Total of all reporting groups
184879|NCT01241279|B2|Baseline|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
184880|NCT01241279|B1|Baseline|Crystalens AO|A silicone multi-piece accommodating intraocular lens
184881|NCT01241279|P2|Participant Flow|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
184882|NCT01241279|P1|Participant Flow|Crystalens AO|A silicone multi-piece accommodating intraocular lens
184890|NCT01241240|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184891|NCT01241240|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184892|NCT01241240|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184893|NCT01241240|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184894|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184895|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184896|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184897|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184898|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184899|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184900|NCT01241240|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
184901|NCT01241240|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
184902|NCT01240915|B9|Baseline|Total|Total of all reporting groups
184903|NCT01240915|B8|Baseline|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184904|NCT01240915|B7|Baseline|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184905|NCT01240915|B6|Baseline|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184906|NCT01240915|B5|Baseline|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184907|NCT01240915|B4|Baseline|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184908|NCT01240915|B3|Baseline|Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo|Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.
184909|NCT01240915|B2|Baseline|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184910|NCT01240915|B1|Baseline|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184911|NCT01240915|P9|Participant Flow|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184912|NCT01240915|P8|Participant Flow|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184913|NCT01240915|P7|Participant Flow|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184914|NCT01240915|P6|Participant Flow|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184915|NCT01240915|P5|Participant Flow|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184916|NCT01240915|P4|Participant Flow|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184917|NCT01240915|P3|Participant Flow|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184918|NCT01240915|P2|Participant Flow|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184919|NCT01240915|P1|Participant Flow|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184920|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184921|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184922|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184923|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184924|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184925|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184926|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184927|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184928|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184929|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184930|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184931|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184932|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184933|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184934|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184935|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184936|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184937|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184938|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184939|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184940|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184941|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184942|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184943|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184944|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184945|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184946|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184947|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184948|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184949|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184950|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184951|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184952|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184953|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185947|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
184954|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184955|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184956|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184957|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184958|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184959|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184960|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184961|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184962|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184963|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184964|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184965|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184966|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184967|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184968|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184969|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184970|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184971|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184972|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184973|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184974|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184975|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184976|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184977|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184978|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184979|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184980|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184981|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184982|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184983|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184984|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184985|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184986|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185948|NCT01237080|E2|Reported Event|GlideScope|50 persons beeing intubated using the GlideScope.
184987|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184988|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184989|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184990|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184991|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
184992|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184993|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184994|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184995|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
184996|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184997|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
184998|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
184999|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185000|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185001|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185002|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185003|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185004|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185005|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185006|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185007|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185008|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185009|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185010|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185011|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185012|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185013|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185014|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185015|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185016|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185017|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185018|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185019|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185949|NCT01237080|E1|Reported Event|Fastrach|50 persons beeing intubated using the Fastrach.
185020|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185021|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185022|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185023|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185024|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185025|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185026|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185027|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185028|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185029|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185030|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185031|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185032|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185033|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185034|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185035|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185036|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185037|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185038|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185039|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185040|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185041|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185042|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185043|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185044|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185045|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185046|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185047|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185048|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185049|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185050|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185051|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185052|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
186061|NCT01236365|E1|Reported Event|Atorvastatin|Atorvastatin: 10 or 20 mg daily
185053|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185054|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185055|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185056|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185057|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185058|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185059|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185060|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185061|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185062|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185063|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185064|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185065|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185066|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185067|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185068|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185069|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185070|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185071|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185072|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185073|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185074|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185075|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185076|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185077|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185078|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185079|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185080|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185081|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185082|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
185083|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
185084|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
185085|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
185086|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
185087|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
185170|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185088|NCT01240915|E9|Reported Event|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185089|NCT01240915|E8|Reported Event|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185090|NCT01240915|E7|Reported Event|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185091|NCT01240915|E6|Reported Event|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185092|NCT01240915|E5|Reported Event|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185093|NCT01240915|E4|Reported Event|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
185094|NCT01240915|E3|Reported Event|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
185095|NCT01240915|E2|Reported Event|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
185096|NCT01240915|E1|Reported Event|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
185097|NCT01240902|B5|Baseline|Total|Total of all reporting groups
185098|NCT01240902|B4|Baseline|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185099|NCT01240902|B3|Baseline|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185100|NCT01240902|B2|Baseline|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185101|NCT01240902|B1|Baseline|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185102|NCT01240902|P4|Participant Flow|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185103|NCT01240902|P3|Participant Flow|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185104|NCT01240902|P2|Participant Flow|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185105|NCT01240902|P1|Participant Flow|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185106|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185107|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185108|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185109|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185110|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185111|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185112|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185113|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185114|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185115|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185116|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185117|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185118|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185119|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185120|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185121|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185122|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185123|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185124|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185125|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185126|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185127|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
186062|NCT01236339|B3|Baseline|Total|Total of all reporting groups
185128|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185129|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185130|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185131|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185132|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185133|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185134|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185135|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185136|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185137|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185138|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185139|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185140|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185141|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185142|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185143|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185144|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185145|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185146|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185147|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185148|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185149|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185150|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185151|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185152|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185153|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185154|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185155|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185156|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185157|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185158|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185159|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185160|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185161|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185162|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185163|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185164|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185165|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185166|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185167|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185168|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185169|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
187061|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
185171|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185172|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185173|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185174|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185175|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185176|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185177|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185178|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185179|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185180|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185181|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185182|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185183|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185184|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185185|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185186|NCT01240902|E4|Reported Event|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
185187|NCT01240902|E3|Reported Event|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
185188|NCT01240902|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
185189|NCT01240902|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
185190|NCT01240811|B4|Baseline|Total|Total of all reporting groups
185191|NCT01240811|B3|Baseline|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
185192|NCT01240811|B2|Baseline|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
185193|NCT01240811|B1|Baseline|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
185194|NCT01240811|P3|Participant Flow|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
185195|NCT01240811|P2|Participant Flow|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
185196|NCT01240811|P1|Participant Flow|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
185197|NCT01240811|O3|Outcome|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
185198|NCT01240811|O2|Outcome|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
185199|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
185200|NCT01240811|E3|Reported Event|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
185201|NCT01240811|E2|Reported Event|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
185202|NCT01240811|E1|Reported Event|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
185203|NCT01240785|B3|Baseline|Total|Total of all reporting groups
185204|NCT01240785|B2|Baseline|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185205|NCT01240785|B1|Baseline|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185206|NCT01240785|P2|Participant Flow|Insulin|
185207|NCT01240785|P1|Participant Flow|Metformin Arm|
185208|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185209|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185210|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185211|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185212|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185213|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185214|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185215|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185216|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
205009|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
185217|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185218|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185219|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185220|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185221|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185222|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185223|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185224|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185225|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185226|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185227|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185228|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185229|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185230|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185231|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185232|NCT01240785|E2|Reported Event|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
185233|NCT01240785|E1|Reported Event|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
185234|NCT01240746|B4|Baseline|Total|Total of all reporting groups
185235|NCT01240746|B3|Baseline|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185236|NCT01240746|B2|Baseline|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185237|NCT01240746|B1|Baseline|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185238|NCT01240746|P3|Participant Flow|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185239|NCT01240746|P2|Participant Flow|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185240|NCT01240746|P1|Participant Flow|Study Group 1 (2010-2011 Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
185241|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185242|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185243|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185244|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185245|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185246|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185247|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185248|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185249|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185250|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185251|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185252|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185253|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185254|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185255|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185256|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185257|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185258|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185259|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185260|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185261|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185262|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185263|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185264|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185265|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185266|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185267|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185268|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185269|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185270|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185271|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185272|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185273|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185274|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185275|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185276|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185277|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185278|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185279|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185280|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185281|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185282|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185283|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185284|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185285|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185286|NCT01240746|E3|Reported Event|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
185287|NCT01240746|E2|Reported Event|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
185288|NCT01240746|E1|Reported Event|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
185289|NCT01240590|B6|Baseline|Total|Total of all reporting groups
185290|NCT01240590|B5|Baseline|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
185291|NCT01240590|B4|Baseline|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
185292|NCT01240590|B3|Baseline|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185293|NCT01240590|B2|Baseline|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185294|NCT01240590|B1|Baseline|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
185295|NCT01240590|P5|Participant Flow|Level 4: Cisplatin|100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
185296|NCT01240590|P4|Participant Flow|Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
185297|NCT01240590|P3|Participant Flow|Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
185298|NCT01240590|P2|Participant Flow|Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
185299|NCT01240590|P1|Participant Flow|Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
185300|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
185301|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
185302|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185303|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185304|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
185305|NCT01240590|O2|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
185306|NCT01240590|O1|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
185307|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 8-20 mg/m(2)crolibulin intravenously.
185308|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
185309|NCT01240590|E5|Reported Event|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
185310|NCT01240590|E4|Reported Event|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
185311|NCT01240590|E3|Reported Event|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185312|NCT01240590|E2|Reported Event|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
185313|NCT01240590|E1|Reported Event|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
185314|NCT01240551|B3|Baseline|Total|Total of all reporting groups
185315|NCT01240551|B2|Baseline|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185316|NCT01240551|B1|Baseline|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185317|NCT01240551|P2|Participant Flow|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185318|NCT01240551|P1|Participant Flow|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185319|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185320|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185321|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185359|NCT01240200|P2|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
185322|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185323|NCT01240551|E2|Reported Event|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185324|NCT01240551|E1|Reported Event|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
185325|NCT01240382|B3|Baseline|Total|Total of all reporting groups
185326|NCT01240382|B2|Baseline|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
185327|NCT01240382|B1|Baseline|3% DE-089|3% DE-089 ophthalmic solution
185328|NCT01240382|P2|Participant Flow|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
185329|NCT01240382|P1|Participant Flow|3% DE-089|3% DE-089 ophthalmic solution
185330|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
185331|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
185332|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
185333|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
185334|NCT01240382|E2|Reported Event|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
185335|NCT01240382|E1|Reported Event|3% DE-089|3% DE-089 ophthalmic solution
185336|NCT01240356|B3|Baseline|Total|Total of all reporting groups
185337|NCT01240356|B2|Baseline|Phase II|Phase II-20 patients with ischemic stroke treated with IV-tPA
185338|NCT01240356|B1|Baseline|Phase I|Non-stroke volunteers.
185339|NCT01240356|P2|Participant Flow|Phase II|Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
185340|NCT01240356|P1|Participant Flow|Phase I|Non-stroke volunteers.
185341|NCT01240356|O1|Outcome|Phase I: Healthy Volunteers|Phase I - A group of 15 Non-stroke healthy volunteers.
185342|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
185343|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
185344|NCT01240356|O1|Outcome|Phase II - Iscehmic Stroke Patients|Phase II - 20 patients with ischemic stroke treated with IV-tPA
185345|NCT01240356|O1|Outcome|Phase 1 (Healthy Volunteers)|Phase I - A group of non-stroke healthy volunteers.
185346|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
185347|NCT01240356|O1|Outcome|Phase I|Non stroke patients
185348|NCT01240356|E2|Reported Event|Phase II - Ischemic Stroke Patients|Phase II - 20 patient with ischemic stroke treated with IV-tPA
185349|NCT01240356|E1|Reported Event|Phase I: Healthy Volunteers|Phase I - 15 non-stroke healthy volunteers.
185350|NCT01240330|B1|Baseline|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185351|NCT01240330|P1|Participant Flow|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185352|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185353|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185354|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185355|NCT01240330|E1|Reported Event|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
185356|NCT01240200|B3|Baseline|Total|Total of all reporting groups
185357|NCT01240200|B2|Baseline|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Glargine SoloSTAR® pen in Period 1 and Glargine vial and syringe in Period 2.
185358|NCT01240200|B1|Baseline|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Glargine vial and syringe in Period 1 and Glargine SoloSTAR pen in Period 2.
185360|NCT01240200|P1|Participant Flow|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
185361|NCT01240200|O2|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
185362|NCT01240200|O1|Outcome|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
185363|NCT01240200|E2|Reported Event|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
185364|NCT01240200|E1|Reported Event|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
185365|NCT01240135|B3|Baseline|Total|Total of all reporting groups
185366|NCT01240135|B2|Baseline|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
185367|NCT01240135|B1|Baseline|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
185368|NCT01240135|P2|Participant Flow|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
185369|NCT01240135|P1|Participant Flow|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
185370|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
185371|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
185372|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
185373|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
185374|NCT01240135|E2|Reported Event|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
185375|NCT01240135|E1|Reported Event|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
185376|NCT01240122|B1|Baseline|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
185377|NCT01240122|P1|Participant Flow|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
185378|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both the Investigational MPS and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
185379|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
185380|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
185381|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
185382|NCT01240122|E1|Reported Event|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
185383|NCT01239992|B1|Baseline|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185384|NCT01239992|P1|Participant Flow|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185385|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185386|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185387|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185388|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185389|NCT01239992|E1|Reported Event|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
185390|NCT01239797|B3|Baseline|Total|Total of all reporting groups
185391|NCT01239797|B2|Baseline|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
185392|NCT01239797|B1|Baseline|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
185438|NCT01239511|P3|Participant Flow|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
187062|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
185393|NCT01239797|P2|Participant Flow|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
185394|NCT01239797|P1|Participant Flow|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
185395|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
185396|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
185397|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
185398|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
185399|NCT01239797|E2|Reported Event|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
185400|NCT01239797|E1|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
185401|NCT01239745|B1|Baseline|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185402|NCT01239745|P1|Participant Flow|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185403|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185404|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185405|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185406|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185439|NCT01239511|P2|Participant Flow|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
185407|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185408|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185409|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185410|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185411|NCT01239745|E1|Reported Event|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
185412|NCT01239732|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185413|NCT01239732|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185414|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185415|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185416|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185417|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185440|NCT01239511|P1|Participant Flow|Placebo Group|placebo capsule 2# t.i.d./day
185441|NCT01239511|O4|Outcome|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
205010|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
185418|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185419|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185420|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185421|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185422|NCT01239732|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
185423|NCT01239680|B3|Baseline|Total|Total of all reporting groups
185424|NCT01239680|B2|Baseline|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
185425|NCT01239680|B1|Baseline|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours
185426|NCT01239680|P2|Participant Flow|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
185427|NCT01239680|P1|Participant Flow|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours
185428|NCT01239680|O2|Outcome|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
185429|NCT01239680|O1|Outcome|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
185430|NCT01239680|E2|Reported Event|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
185431|NCT01239680|E1|Reported Event|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
185432|NCT01239511|B5|Baseline|Total|Total of all reporting groups
185433|NCT01239511|B4|Baseline|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
185434|NCT01239511|B3|Baseline|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
185435|NCT01239511|B2|Baseline|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
185436|NCT01239511|B1|Baseline|Placebo Group|placebo capsule 2# t.i.d./day
185437|NCT01239511|P4|Participant Flow|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
188251|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
185442|NCT01239511|O3|Outcome|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
185443|NCT01239511|O2|Outcome|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
185444|NCT01239511|O1|Outcome|Placebo Group|placebo capsule 2# t.i.d./day
185445|NCT01239511|E4|Reported Event|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
185446|NCT01239511|E3|Reported Event|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
185447|NCT01239511|E2|Reported Event|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
185448|NCT01239511|E1|Reported Event|Placebo Group|placebo capsule 2# t.i.d./day
185449|NCT01239355|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185450|NCT01239355|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185451|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185452|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185453|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185454|NCT01239355|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
185455|NCT01239316|B1|Baseline|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185456|NCT01239316|P1|Participant Flow|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185457|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185458|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185459|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185460|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185461|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185462|NCT01239316|E1|Reported Event|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
185463|NCT01239212|B1|Baseline|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
185464|NCT01239212|P1|Participant Flow|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
185465|NCT01239212|O1|Outcome|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
185466|NCT01239212|E1|Reported Event|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
185467|NCT01239121|B4|Baseline|Total|Total of all reporting groups
185468|NCT01239121|B3|Baseline|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185469|NCT01239121|B2|Baseline|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185470|NCT01239121|B1|Baseline|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185471|NCT01239121|P3|Participant Flow|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185472|NCT01239121|P2|Participant Flow|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185519|NCT01238991|B5|Baseline|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185473|NCT01239121|P1|Participant Flow|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185474|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185475|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185476|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185477|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185478|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185479|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185480|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185481|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185482|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185483|NCT01239121|E3|Reported Event|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185484|NCT01239121|E2|Reported Event|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
185485|NCT01239121|E1|Reported Event|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
185486|NCT01239056|B1|Baseline|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185487|NCT01239056|P1|Participant Flow|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185488|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185634|NCT01238861|P6|Participant Flow|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185489|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185490|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185491|NCT01239056|E1|Reported Event|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
185492|NCT01239043|B3|Baseline|Total|Total of all reporting groups
185493|NCT01239043|B2|Baseline|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185494|NCT01239043|B1|Baseline|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185495|NCT01239043|P2|Participant Flow|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185496|NCT01239043|P1|Participant Flow|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185497|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185498|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185499|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185500|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185501|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185502|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185503|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185504|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185505|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185506|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185507|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185508|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185509|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185510|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185511|NCT01239043|E2|Reported Event|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
185512|NCT01239043|E1|Reported Event|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
185513|NCT01238991|B11|Baseline|Total|Total of all reporting groups
185514|NCT01238991|B10|Baseline|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185515|NCT01238991|B9|Baseline|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185516|NCT01238991|B8|Baseline|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185517|NCT01238991|B7|Baseline|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185518|NCT01238991|B6|Baseline|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185520|NCT01238991|B4|Baseline|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185521|NCT01238991|B3|Baseline|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185522|NCT01238991|B2|Baseline|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185523|NCT01238991|B1|Baseline|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185524|NCT01238991|P10|Participant Flow|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185525|NCT01238991|P9|Participant Flow|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185526|NCT01238991|P8|Participant Flow|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185527|NCT01238991|P7|Participant Flow|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185528|NCT01238991|P6|Participant Flow|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185529|NCT01238991|P5|Participant Flow|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185530|NCT01238991|P4|Participant Flow|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185531|NCT01238991|P3|Participant Flow|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185532|NCT01238991|P2|Participant Flow|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185533|NCT01238991|P1|Participant Flow|3 μg ACC-001+QS-21|A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185534|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185535|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185536|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185537|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185538|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185539|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185540|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185541|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185542|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185543|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185544|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185545|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185546|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185547|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185548|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185549|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185550|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185551|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185552|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185553|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185554|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185555|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185556|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185557|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185558|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185559|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185560|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185561|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185562|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185563|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185564|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185565|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185566|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185567|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185568|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185569|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185570|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185571|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185572|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185573|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185574|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185575|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185940|NCT01237080|B2|Baseline|GlideScope|50 persons beeing intubated using the GlideScope.
185576|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185577|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185578|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185579|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185580|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185581|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185582|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185583|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185584|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
185585|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185586|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185587|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185588|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185589|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185590|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185591|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185592|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185593|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185594|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185595|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185596|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185597|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185598|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185599|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185600|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185601|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185602|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185603|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185604|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185605|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185606|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185607|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185608|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185609|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185610|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185611|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185612|NCT01238991|E7|Reported Event|Total|All participants
185613|NCT01238991|E6|Reported Event|30μg Control|A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185614|NCT01238991|E5|Reported Event|30μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185615|NCT01238991|E4|Reported Event|10μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185616|NCT01238991|E3|Reported Event|10ug ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185617|NCT01238991|E2|Reported Event|3μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
185618|NCT01238991|E1|Reported Event|3μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
185619|NCT01238900|B1|Baseline|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185620|NCT01238900|P1|Participant Flow|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185621|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185622|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185623|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185624|NCT01238900|O1|Outcome|Per- Protocol Analysis of Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185625|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185626|NCT01238900|E1|Reported Event|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
185627|NCT01238861|B7|Baseline|Total|Total of all reporting groups
185628|NCT01238861|B6|Baseline|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185629|NCT01238861|B5|Baseline|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185630|NCT01238861|B4|Baseline|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185631|NCT01238861|B3|Baseline|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185632|NCT01238861|B2|Baseline|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185633|NCT01238861|B1|Baseline|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185635|NCT01238861|P5|Participant Flow|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185636|NCT01238861|P4|Participant Flow|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185637|NCT01238861|P3|Participant Flow|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185638|NCT01238861|P2|Participant Flow|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185639|NCT01238861|P1|Participant Flow|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185640|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185641|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185642|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185643|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185644|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185645|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185646|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185647|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185648|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185649|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185650|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185651|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185652|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185653|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185654|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185655|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185656|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185657|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185658|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185659|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185660|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185661|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185662|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185663|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185664|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185665|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185666|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185667|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185668|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185669|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
185670|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185671|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185672|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185673|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185674|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185675|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185676|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185677|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185678|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185679|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185680|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185681|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
185682|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185683|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185684|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185685|NCT01238861|O1|Outcome|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
185686|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185687|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185688|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185689|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185690|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185691|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
185692|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185693|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185694|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185695|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
185696|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185697|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185698|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185699|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
185700|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185701|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185702|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185703|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185704|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185705|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
185706|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185707|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185708|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185941|NCT01237080|B1|Baseline|Fastrach|50 persons beeing intubated using the Fastrach.
185709|NCT01238861|O1|Outcome|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
185710|NCT01238861|E6|Reported Event|EOS NEG Benralizumab 100 mg|EOS- participants received two benralizumab 50 mg injections subcutaneously.
185711|NCT01238861|E5|Reported Event|EOS NEG Placebo|EOS- participants received two placebo injections subcutaneously.
185712|NCT01238861|E4|Reported Event|EOS POS Benralizumab 100 mg|EOS+ participants received two benralizumab 50 mg injections subcutaneously.
185713|NCT01238861|E3|Reported Event|EOS POS Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
185714|NCT01238861|E2|Reported Event|EOS POS Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
185715|NCT01238861|E1|Reported Event|EOS POS Placebo|EOS+ participants received two placebo injections subcutaneously.
185716|NCT01238848|B3|Baseline|Total|Total of all reporting groups
185717|NCT01238848|B2|Baseline|Normal|Normal saline (sodium chloride 0.9%) + albuterol
185718|NCT01238848|B1|Baseline|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
185719|NCT01238848|P2|Participant Flow|Normal|Normal saline (sodium chloride 0.9%) + albuterol
185720|NCT01238848|P1|Participant Flow|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
185721|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
185722|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
185723|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
185724|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
185725|NCT01238848|E2|Reported Event|Normal|Normal saline (sodium chloride 0.9%) + albuterol
185726|NCT01238848|E1|Reported Event|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
185727|NCT01238822|B1|Baseline|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
185728|NCT01238822|P1|Participant Flow|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
185729|NCT01238822|O4|Outcome|High Dosage|54 mg methylphenidate if >25 kg; 36 mg methylphenidate if < 25 kg.
185730|NCT01238822|O3|Outcome|Medium Dosage|36 mg methylphenidate if >25 kg; 27 mg methylphenidate if < 25 kg.
185731|NCT01238822|O2|Outcome|Low Dosage|18 mg methylphenidate
185732|NCT01238822|O1|Outcome|Placebo|placebo
185733|NCT01238822|E4|Reported Event|High Dosage|54 mg methylphenidate
185734|NCT01238822|E3|Reported Event|Medium Dosage|Medium Dosage: 36 mg methylphenidate
185735|NCT01238822|E2|Reported Event|Low Dosage|Low dose: 18 mg methylphenidate
185736|NCT01238822|E1|Reported Event|Placebo|
185737|NCT01238640|B1|Baseline|Overall Study|
185738|NCT01238640|P1|Participant Flow|Overall Study|
185739|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
185740|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
185741|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
185742|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
185743|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
185744|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
185745|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
185746|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
185747|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
185748|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
185749|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
185750|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
185751|NCT01238640|E3|Reported Event|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
185752|NCT01238640|E2|Reported Event|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
185753|NCT01238640|E1|Reported Event|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
185754|NCT01238575|B3|Baseline|Total|Total of all reporting groups
185755|NCT01238575|B2|Baseline|Inactive Placebo|placebo: Administered for up to 8 weeks.
185756|NCT01238575|B1|Baseline|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185757|NCT01238575|P2|Participant Flow|Inactive Placebo|placebo: Administered for up to 8 weeks.
185758|NCT01238575|P1|Participant Flow|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185759|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185760|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185761|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185762|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185763|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185764|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185765|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185766|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185767|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185768|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185769|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185770|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185771|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185772|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185773|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185774|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185775|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185776|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185777|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185778|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185779|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185780|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185781|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185782|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185783|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185784|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185785|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185786|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185787|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185788|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185789|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
185790|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185791|NCT01238575|E2|Reported Event|Inactive Placebo|placebo: Administered for up to 8 weeks.
185792|NCT01238575|E1|Reported Event|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
185793|NCT01238471|B3|Baseline|Total|Total of all reporting groups
185794|NCT01238471|B2|Baseline|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
185795|NCT01238471|B1|Baseline|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
185796|NCT01238471|P2|Participant Flow|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
185797|NCT01238471|P1|Participant Flow|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
185798|NCT01238471|O2|Outcome|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
185799|NCT01238471|O1|Outcome|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
185800|NCT01238471|E2|Reported Event|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
185801|NCT01238471|E1|Reported Event|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
185802|NCT01238341|B1|Baseline|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185803|NCT01238341|P1|Participant Flow|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185804|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185805|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185806|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185807|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185808|NCT01238341|E1|Reported Event|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
185809|NCT01238211|B1|Baseline|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
185810|NCT01238211|P1|Participant Flow|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
185811|NCT01238211|O1|Outcome|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
185812|NCT01238211|E1|Reported Event|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
185813|NCT01237613|B1|Baseline|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185814|NCT01237613|P1|Participant Flow|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185815|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185816|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185817|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185818|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185819|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patientschronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185820|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185821|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185822|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185823|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185824|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185825|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185826|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185827|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185828|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185829|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185830|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185831|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185832|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185833|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185834|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185835|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185836|NCT01237613|E1|Reported Event|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
185837|NCT01237353|B1|Baseline|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
185838|NCT01237353|P1|Participant Flow|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
185839|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
185840|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
185841|NCT01237353|E1|Reported Event|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
185842|NCT01237340|B1|Baseline|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185843|NCT01237340|P1|Participant Flow|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185844|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185845|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185846|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185847|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185848|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185849|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185850|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185942|NCT01237080|P2|Participant Flow|GlideScope|50 persons beeing intubated using the GlideScope.
185851|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185852|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185853|NCT01237340|E1|Reported Event|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
185854|NCT01237327|B3|Baseline|Total|Total of all reporting groups
185855|NCT01237327|B2|Baseline|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185856|NCT01237327|B1|Baseline|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185857|NCT01237327|P2|Participant Flow|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185858|NCT01237327|P1|Participant Flow|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185859|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185860|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185861|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185862|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185863|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185864|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185865|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185866|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185867|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185868|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185869|NCT01237327|E2|Reported Event|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
185870|NCT01237327|E1|Reported Event|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
185871|NCT01237301|B3|Baseline|Total|Total of all reporting groups
185872|NCT01237301|B2|Baseline|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185873|NCT01237301|B1|Baseline|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185874|NCT01237301|P2|Participant Flow|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185875|NCT01237301|P1|Participant Flow|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185876|NCT01237301|O2|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185877|NCT01237301|O1|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185878|NCT01237301|E2|Reported Event|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185879|NCT01237301|E1|Reported Event|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
185880|NCT01237223|B7|Baseline|Total|Total of all reporting groups
185881|NCT01237223|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185882|NCT01237223|B5|Baseline|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185883|NCT01237223|B4|Baseline|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185884|NCT01237223|B3|Baseline|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185885|NCT01237223|B2|Baseline|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185943|NCT01237080|P1|Participant Flow|Fastrach|50 persons beeing intubated using the Fastrach.
185886|NCT01237223|B1|Baseline|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
185887|NCT01237223|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185888|NCT01237223|P5|Participant Flow|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185889|NCT01237223|P4|Participant Flow|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185890|NCT01237223|P3|Participant Flow|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185891|NCT01237223|P2|Participant Flow|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185892|NCT01237223|P1|Participant Flow|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
185893|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185894|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185895|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185896|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185897|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185898|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
185899|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185900|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185901|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185902|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185944|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
185903|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185904|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
185905|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185906|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185907|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185908|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185909|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185910|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
185911|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185912|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185913|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185914|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185915|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185916|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
185917|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185918|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185919|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185945|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
185946|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
185920|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185921|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185922|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
185923|NCT01237223|E7|Reported Event|Placebo (Single-Blind run-in Period)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
185924|NCT01237223|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185925|NCT01237223|E5|Reported Event|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
185926|NCT01237223|E4|Reported Event|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
185927|NCT01237223|E3|Reported Event|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185928|NCT01237223|E2|Reported Event|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
185929|NCT01237223|E1|Reported Event|Placebo (Double Blind)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
185930|NCT01237197|B3|Baseline|Total|Total of all reporting groups
185931|NCT01237197|B2|Baseline|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
185932|NCT01237197|B1|Baseline|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
185933|NCT01237197|P2|Participant Flow|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
185934|NCT01237197|P1|Participant Flow|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
185935|NCT01237197|O2|Outcome|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
185936|NCT01237197|O1|Outcome|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
185937|NCT01237197|E2|Reported Event|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
185938|NCT01237197|E1|Reported Event|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
185939|NCT01237080|B3|Baseline|Total|Total of all reporting groups
188252|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
185950|NCT01237054|B1|Baseline|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
185951|NCT01237054|P1|Participant Flow|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
185952|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
185953|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
185954|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
185955|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
185956|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
185957|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
185958|NCT01237054|E1|Reported Event|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
185959|NCT01236573|B12|Baseline|Total|Total of all reporting groups
185960|NCT01236573|B11|Baseline|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185961|NCT01236573|B10|Baseline|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185962|NCT01236573|B9|Baseline|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185963|NCT01236573|B8|Baseline|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185964|NCT01236573|B7|Baseline|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186046|NCT01236378|E1|Reported Event|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186047|NCT01236365|B3|Baseline|Total|Total of all reporting groups
185965|NCT01236573|B6|Baseline|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185966|NCT01236573|B5|Baseline|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185967|NCT01236573|B4|Baseline|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185968|NCT01236573|B3|Baseline|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185969|NCT01236573|B2|Baseline|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185970|NCT01236573|B1|Baseline|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185971|NCT01236573|P11|Participant Flow|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185972|NCT01236573|P10|Participant Flow|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185973|NCT01236573|P9|Participant Flow|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185974|NCT01236573|P8|Participant Flow|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185975|NCT01236573|P7|Participant Flow|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185976|NCT01236573|P6|Participant Flow|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186048|NCT01236365|B2|Baseline|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
186049|NCT01236365|B1|Baseline|Atorvastatin|Atorvastatin: 10 or 20 mg daily
185977|NCT01236573|P5|Participant Flow|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185978|NCT01236573|P4|Participant Flow|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185979|NCT01236573|P3|Participant Flow|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185980|NCT01236573|P2|Participant Flow|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185981|NCT01236573|P1|Participant Flow|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185982|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185983|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185984|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185985|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185986|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185987|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185988|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186050|NCT01236365|P2|Participant Flow|Placebo|Placebo: 10 or 20 mg daily
186051|NCT01236365|P1|Participant Flow|Atorvastatin|Atorvastatin: 10 or 20 mg daily
186052|NCT01236365|O4|Outcome|Placebo hsCRP at 6 Months|
185989|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185990|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185991|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185992|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185993|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185994|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185995|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185996|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185997|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185998|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
185999|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186000|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186053|NCT01236365|O3|Outcome|Placebo hsCRP at Randomization|
186054|NCT01236365|O2|Outcome|Atorvastatin hsCRP at 6 Months|
186055|NCT01236365|O1|Outcome|Atorvastatin hsCRP at Randomization|
186001|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186002|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186003|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186004|NCT01236573|O1|Outcome|All Phase I Participants|All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
186005|NCT01236573|E11|Reported Event|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186006|NCT01236573|E10|Reported Event|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186007|NCT01236573|E9|Reported Event|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186008|NCT01236573|E8|Reported Event|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186009|NCT01236573|E7|Reported Event|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186010|NCT01236573|E6|Reported Event|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186011|NCT01236573|E5|Reported Event|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186012|NCT01236573|E4|Reported Event|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186056|NCT01236365|O4|Outcome|Placebo LDL-C at 6 Months|
186057|NCT01236365|O3|Outcome|Placebo LDL-C at Randomization|
186058|NCT01236365|O2|Outcome|Atorvastatin LDL-C at 6 Months|
186013|NCT01236573|E3|Reported Event|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186014|NCT01236573|E2|Reported Event|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186015|NCT01236573|E1|Reported Event|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
186016|NCT01236534|B3|Baseline|Total|Total of all reporting groups
186017|NCT01236534|B2|Baseline|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
186018|NCT01236534|B1|Baseline|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
186019|NCT01236534|P2|Participant Flow|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
186020|NCT01236534|P1|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
186021|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
186022|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
186023|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
186024|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
186025|NCT01236534|E2|Reported Event|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
186026|NCT01236534|E1|Reported Event|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
186027|NCT01236391|B1|Baseline|PCI-32765|PCI-32765: 560 mg daily
186028|NCT01236391|P1|Participant Flow|PCI-32765|Participants received 560 mg daily
186029|NCT01236391|O1|Outcome|EORTC QLQ-C30|Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
186030|NCT01236391|O2|Outcome|PCI-45227 (Metabolite)- Day 8|PCI-32765: 560 mg daily
186031|NCT01236391|O1|Outcome|PCI-32765 - Day 8|PCI-32765: 560 mg daily
186032|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
186033|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
186034|NCT01236391|E1|Reported Event|PCI-32765|PCI-32765: 560 mg daily
186035|NCT01236378|B1|Baseline|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186036|NCT01236378|P1|Participant Flow|Sirolimus|Sirolimus, 1 milligram (mg) tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last pharmacokinetic (PK) sample collection.
186037|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186038|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186039|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186040|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186041|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186042|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186043|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186044|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186045|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
186059|NCT01236365|O1|Outcome|Atorvastatin LDL-C at Randomization|
186060|NCT01236365|E2|Reported Event|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
186063|NCT01236339|B2|Baseline|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
186064|NCT01236339|B1|Baseline|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186065|NCT01236339|P2|Participant Flow|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)"
186066|NCT01236339|P1|Participant Flow|TIPS|TIPS with GORE® VIATORR® TIPS Endoprosthesis
186067|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186068|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186069|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186070|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186071|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186072|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186073|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186074|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186075|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186076|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186077|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186078|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186079|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
186080|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186081|NCT01236339|E2|Reported Event|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
186082|NCT01236339|E1|Reported Event|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
186083|NCT01236326|B3|Baseline|Total|Total of all reporting groups
186084|NCT01236326|B2|Baseline|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186085|NCT01236326|B1|Baseline|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186086|NCT01236326|P2|Participant Flow|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186087|NCT01236326|P1|Participant Flow|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186088|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186089|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186090|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186091|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186092|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186093|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186094|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186095|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186096|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186097|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186098|NCT01236326|E2|Reported Event|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
186099|NCT01236326|E1|Reported Event|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
186100|NCT01236300|B1|Baseline|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
186972|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186101|NCT01236300|P1|Participant Flow|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
186102|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
186103|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
186104|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
186105|NCT01236300|O1|Outcome|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
186106|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
186107|NCT01236300|E1|Reported Event|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
186108|NCT01236196|B3|Baseline|Total|Total of all reporting groups
186109|NCT01236196|B2|Baseline|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186110|NCT01236196|B1|Baseline|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186111|NCT01236196|P2|Participant Flow|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186112|NCT01236196|P1|Participant Flow|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186113|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186114|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186115|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186116|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186117|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186118|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186119|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186120|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186121|NCT01236196|E2|Reported Event|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
186122|NCT01236196|E1|Reported Event|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
186123|NCT01236170|B1|Baseline|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186124|NCT01236170|P1|Participant Flow|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186125|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186126|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186127|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186128|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186129|NCT01236170|E1|Reported Event|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
186130|NCT01236118|B4|Baseline|Total|Total of all reporting groups
186131|NCT01236118|B3|Baseline|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
186151|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
188253|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
186132|NCT01236118|B2|Baseline|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186133|NCT01236118|B1|Baseline|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186134|NCT01236118|P3|Participant Flow|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
186135|NCT01236118|P2|Participant Flow|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186136|NCT01236118|P1|Participant Flow|30 mg LY2439821|Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
186137|NCT01236118|O3|Outcome|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
186138|NCT01236118|O2|Outcome|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186139|NCT01236118|O1|Outcome|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186140|NCT01236118|E3|Reported Event|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
186141|NCT01236118|E2|Reported Event|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186142|NCT01236118|E1|Reported Event|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
186143|NCT01236105|B1|Baseline|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
186144|NCT01236105|P1|Participant Flow|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
186145|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
186146|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
186147|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
186148|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
186149|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
186150|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
186152|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
186153|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
186154|NCT01236105|E3|Reported Event|LY2624803 Evening Dosing|LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast.
186155|NCT01236105|E2|Reported Event|LY2624803 Morning Dosing + Activated Charcoal|LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
186156|NCT01236105|E1|Reported Event|LY2624803 Morning Dosing|LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
186157|NCT01236053|B23|Baseline|Total|Total of all reporting groups
186158|NCT01236053|B22|Baseline|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186159|NCT01236053|B21|Baseline|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186160|NCT01236053|B20|Baseline|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186161|NCT01236053|B19|Baseline|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186162|NCT01236053|B18|Baseline|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186163|NCT01236053|B17|Baseline|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186164|NCT01236053|B16|Baseline|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186165|NCT01236053|B15|Baseline|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186166|NCT01236053|B14|Baseline|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186167|NCT01236053|B13|Baseline|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186214|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186168|NCT01236053|B12|Baseline|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186169|NCT01236053|B11|Baseline|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186170|NCT01236053|B10|Baseline|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186171|NCT01236053|B9|Baseline|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186172|NCT01236053|B8|Baseline|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186173|NCT01236053|B7|Baseline|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186174|NCT01236053|B6|Baseline|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186175|NCT01236053|B5|Baseline|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186176|NCT01236053|B4|Baseline|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186177|NCT01236053|B3|Baseline|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186178|NCT01236053|B2|Baseline|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186179|NCT01236053|B1|Baseline|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186180|NCT01236053|P22|Participant Flow|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186973|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186181|NCT01236053|P21|Participant Flow|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186182|NCT01236053|P20|Participant Flow|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186183|NCT01236053|P19|Participant Flow|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186184|NCT01236053|P18|Participant Flow|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186185|NCT01236053|P17|Participant Flow|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186186|NCT01236053|P16|Participant Flow|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186187|NCT01236053|P15|Participant Flow|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186188|NCT01236053|P14|Participant Flow|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186189|NCT01236053|P13|Participant Flow|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186190|NCT01236053|P12|Participant Flow|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186191|NCT01236053|P11|Participant Flow|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186192|NCT01236053|P10|Participant Flow|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186193|NCT01236053|P9|Participant Flow|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186194|NCT01236053|P8|Participant Flow|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186195|NCT01236053|P7|Participant Flow|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186196|NCT01236053|P6|Participant Flow|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186197|NCT01236053|P5|Participant Flow|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186198|NCT01236053|P4|Participant Flow|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186199|NCT01236053|P3|Participant Flow|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186200|NCT01236053|P2|Participant Flow|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186201|NCT01236053|P1|Participant Flow|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186202|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186203|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
186204|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186205|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
186206|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186207|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
186208|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186209|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
186210|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186211|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
186212|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186213|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
186974|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186215|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
186216|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186217|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
186218|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186219|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
186220|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186221|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
186222|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186223|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
186224|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186225|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
186226|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186227|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
186228|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186229|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
186230|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186231|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
186232|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186233|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
186234|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186235|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
186236|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186237|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
186238|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186239|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
186240|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186241|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
186242|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186243|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
186244|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186245|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
186978|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186246|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186247|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
186248|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186249|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
186250|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186251|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
186252|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186253|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
186254|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186255|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
186256|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186257|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
186258|NCT01236053|O2|Outcome|Controls|Controls
186259|NCT01236053|O1|Outcome|Cases|Cases
186260|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186261|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
186262|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186263|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
186264|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186265|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
186266|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186267|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
186268|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186269|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
186270|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186271|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
186272|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice
186273|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
186274|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186275|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
186276|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186277|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
186278|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186279|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
186280|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186281|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
186282|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186283|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
186284|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186285|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
186286|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186287|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
186288|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186289|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
186290|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186291|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
186292|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186293|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
186294|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186295|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
186296|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186297|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
186298|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186299|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
186300|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186301|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
186302|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186303|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
186304|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186305|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
186306|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186307|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
186308|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186309|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
186310|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
186311|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
186312|NCT01236053|E22|Reported Event|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186313|NCT01236053|E21|Reported Event|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186314|NCT01236053|E20|Reported Event|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186315|NCT01236053|E19|Reported Event|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186316|NCT01236053|E18|Reported Event|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186317|NCT01236053|E17|Reported Event|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186318|NCT01236053|E16|Reported Event|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186319|NCT01236053|E15|Reported Event|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186320|NCT01236053|E14|Reported Event|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186321|NCT01236053|E13|Reported Event|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186322|NCT01236053|E12|Reported Event|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186323|NCT01236053|E11|Reported Event|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186324|NCT01236053|E10|Reported Event|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186325|NCT01236053|E9|Reported Event|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186326|NCT01236053|E8|Reported Event|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186327|NCT01236053|E7|Reported Event|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186328|NCT01236053|E6|Reported Event|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186329|NCT01236053|E5|Reported Event|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186330|NCT01236053|E4|Reported Event|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186331|NCT01236053|E3|Reported Event|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186332|NCT01236053|E2|Reported Event|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
186333|NCT01236053|E1|Reported Event|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
186334|NCT01236001|B3|Baseline|Total|Total of all reporting groups
186335|NCT01236001|B2|Baseline|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186336|NCT01236001|B1|Baseline|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186337|NCT01236001|P2|Participant Flow|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186338|NCT01236001|P1|Participant Flow|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186339|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
186340|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186341|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186342|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186343|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186344|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186345|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186346|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186347|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186348|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186349|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186350|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186351|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186352|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186353|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186354|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186355|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186356|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186357|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186358|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186359|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186360|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186361|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186362|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
186363|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
186364|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186365|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
186366|NCT01236001|E1|Reported Event|Vimpat® Treatment|Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
186367|NCT01235923|B3|Baseline|Total|Total of all reporting groups
186368|NCT01235923|B2|Baseline|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
186369|NCT01235923|B1|Baseline|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
186370|NCT01235923|P2|Participant Flow|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
186371|NCT01235923|P1|Participant Flow|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
186372|NCT01235923|O2|Outcome|Three Times a Week Epo|
186373|NCT01235923|O1|Outcome|Weekly Epo|
186374|NCT01235923|O2|Outcome|Three Times a Week Epo|
186375|NCT01235923|O1|Outcome|Weekly Epo|
186376|NCT01235923|E2|Reported Event|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
186377|NCT01235923|E1|Reported Event|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
186378|NCT01235910|B1|Baseline|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
186379|NCT01235910|P1|Participant Flow|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
186380|NCT01235910|O1|Outcome|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
186381|NCT01235910|E1|Reported Event|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
186382|NCT01235897|B1|Baseline|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
186383|NCT01235897|P1|Participant Flow|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
186384|NCT01235897|O1|Outcome|MK-2206|MK-2206 given orally at a dose of 135 mg weekly + Trastuzumab 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg + Paclitaxel 80 mg/m2 weekly
186385|NCT01235897|O1|Outcome|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
186386|NCT01235897|E1|Reported Event|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
186387|NCT01235741|B4|Baseline|Total|Total of all reporting groups
186388|NCT01235741|B3|Baseline|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186389|NCT01235741|B2|Baseline|Placebo|Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
186390|NCT01235741|B1|Baseline|Non-Randomized Lead-in LCD|6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period.
186391|NCT01235741|P3|Participant Flow|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks
186392|NCT01235741|P2|Participant Flow|Placebo|Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
186393|NCT01235741|P1|Participant Flow|Low Calorie Diet Only|6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period.
186394|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186395|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186396|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186397|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
186398|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186399|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
186400|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186401|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186402|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186403|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186404|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186405|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186406|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186407|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186408|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186409|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186410|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186411|NCT01235741|O4|Outcome|Post Treatment Pramlintide + Metreleptin Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
186412|NCT01235741|O3|Outcome|Post Treatment Placebo Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
186413|NCT01235741|O2|Outcome|On Treatment Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186414|NCT01235741|O1|Outcome|On Treatment Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186415|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
186416|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
186417|NCT01235741|E2|Reported Event|Pramlintide + Metreleptin|Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment).
186418|NCT01235741|E1|Reported Event|Placebo-P + Placebo-M|Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total).
186419|NCT01235728|B1|Baseline|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
186420|NCT01235728|P8|Participant Flow|Treatment Sequence 8|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
186421|NCT01235728|P7|Participant Flow|Treatment Sequence 7|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
186422|NCT01235728|P6|Participant Flow|Treatment Sequence 6|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
186423|NCT01235728|P5|Participant Flow|Treatment Sequence 5|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
186424|NCT01235728|P4|Participant Flow|Treatment Sequence 4|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
186425|NCT01235728|P3|Participant Flow|Treatment Sequence 3|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
186426|NCT01235728|P2|Participant Flow|Treatment Sequence 2|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
186427|NCT01235728|P1|Participant Flow|Treatment Sequence 1|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
188254|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
186428|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
186429|NCT01235728|O2|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
186430|NCT01235728|O1|Outcome|Calcitriol 0.0003%|Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
186431|NCT01235728|O2|Outcome|MK-0873 Vehicle|Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
186432|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
186433|NCT01235728|E1|Reported Event|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
186434|NCT01235715|B3|Baseline|Total|Total of all reporting groups
186435|NCT01235715|B2|Baseline|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186436|NCT01235715|B1|Baseline|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186437|NCT01235715|P2|Participant Flow|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186438|NCT01235715|P1|Participant Flow|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186439|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186440|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186441|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186442|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186443|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186444|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186445|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186446|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186447|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186448|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186449|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186450|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186451|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186452|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186453|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186454|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186455|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
188255|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
186456|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186457|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186458|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186459|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186460|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186461|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186462|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186463|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186464|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186465|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186466|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186467|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186468|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186469|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186470|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186471|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186472|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186473|NCT01235715|E2|Reported Event|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
186474|NCT01235715|E1|Reported Event|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
186475|NCT01235598|B3|Baseline|Total|Total of all reporting groups
186476|NCT01235598|B2|Baseline|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186477|NCT01235598|B1|Baseline|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186478|NCT01235598|P2|Participant Flow|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186479|NCT01235598|P1|Participant Flow|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186480|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186481|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186482|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186515|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186483|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186484|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186485|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186486|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186487|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186488|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186489|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186490|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186491|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186492|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186493|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186494|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186495|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186496|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186497|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186498|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186499|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186500|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186501|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186502|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186503|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186504|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186505|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186506|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186507|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186508|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186509|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186510|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
186511|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186512|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186513|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186514|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
187057|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
186516|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186517|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186518|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186519|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
186520|NCT01235598|E1|Reported Event|Certolizumab Pegol (CZP) at Any Time|"Eligible subjects were allocated to the following study treatments in a 2:1 ratio:~Certolizumab Pegol (CZP) 400mg for subcutaneous injection (sc) at Weeks 0, 2, and 4, followed by CZP 200mg sc and placebo (saline solution) at Week 6 and CZP 200mg at Weeks 8, 10, 12, 14, and 16 or~Placebo (saline solution) at Day 0 and then CZP 400mg sc at Weeks 2, 4, and 6 followed by CZP 200mg sc at Weeks 8, 10, 12, 14, and 16"
186521|NCT01235507|B1|Baseline|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186522|NCT01235507|P1|Participant Flow|Tocilizumab Plus Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum 800 mg) intravenously (IV) every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg per week (mg/week) of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186523|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186524|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186525|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186526|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186527|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186528|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186529|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186530|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186531|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186532|NCT01235507|E1|Reported Event|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
186533|NCT01235442|B3|Baseline|Total|Total of all reporting groups
186534|NCT01235442|B2|Baseline|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186535|NCT01235442|B1|Baseline|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186536|NCT01235442|P2|Participant Flow|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186537|NCT01235442|P1|Participant Flow|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186538|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186539|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186540|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186541|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186542|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186543|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186544|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186545|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186546|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186547|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186548|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186549|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186550|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186551|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186552|NCT01235442|E2|Reported Event|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
186553|NCT01235442|E1|Reported Event|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
186554|NCT01235403|B1|Baseline|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186555|NCT01235403|P1|Participant Flow|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186556|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186557|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186558|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186559|NCT01235403|E1|Reported Event|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
186560|NCT01235377|B3|Baseline|Total|Total of all reporting groups
186649|NCT01234922|P4|Participant Flow|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
186561|NCT01235377|B2|Baseline|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186562|NCT01235377|B1|Baseline|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186563|NCT01235377|P2|Participant Flow|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186564|NCT01235377|P1|Participant Flow|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186565|NCT01235377|O2|Outcome|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186566|NCT01235377|O1|Outcome|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186567|NCT01235377|E2|Reported Event|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186568|NCT01235377|E1|Reported Event|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
186569|NCT01235338|B3|Baseline|Total|Total of all reporting groups
186570|NCT01235338|B2|Baseline|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186571|NCT01235338|B1|Baseline|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186572|NCT01235338|P2|Participant Flow|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186573|NCT01235338|P1|Participant Flow|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186574|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186575|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186576|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186577|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186650|NCT01234922|P3|Participant Flow|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
186651|NCT01234922|P2|Participant Flow|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
186578|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186579|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186580|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186581|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186582|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186583|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186584|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186585|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186586|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186587|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186588|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186589|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186590|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186591|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186652|NCT01234922|P1|Participant Flow|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
186653|NCT01234922|O4|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
186592|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186593|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186594|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186595|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186596|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186597|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186598|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186599|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186600|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186601|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186602|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186603|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186604|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186605|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186654|NCT01234922|O3|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
186655|NCT01234922|O2|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
187058|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
186606|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186607|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186608|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186609|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
186610|NCT01235338|E4|Reported Event|Venlafaxine XR Tapering|Tapering dosing period (Effexor XR 150 and 75 mg)
186611|NCT01235338|E3|Reported Event|Venlafaxine XR Titration|Titration dosing period (Effexor XR 75, 150, and 225 mg)
186612|NCT01235338|E2|Reported Event|LDX + Venlafaxine XR/Venlafaxine XR + LDX|Combination dosing periods
186613|NCT01235338|E1|Reported Event|LDX (SPD489)|Titration dosing period
186614|NCT01235234|B4|Baseline|Total|Total of all reporting groups
186615|NCT01235234|B3|Baseline|Placebo|CF101: orally q12h
186616|NCT01235234|B2|Baseline|CF101 1 mg|CF101: orally q12h
186617|NCT01235234|B1|Baseline|CF101 0.1 mg|CF101: orally q12h
186618|NCT01235234|P3|Participant Flow|Placebo|CF101: orally q12h
186619|NCT01235234|P2|Participant Flow|CF101 1 mg|CF101: orally q12h
186620|NCT01235234|P1|Participant Flow|CF101 0.1 mg|CF101: orally q12h
186621|NCT01235234|O3|Outcome|Placebo|CF101: orally q12h
186622|NCT01235234|O2|Outcome|CF101 1 mg|CF101: orally q12h
186623|NCT01235234|O1|Outcome|CF101 0.1 mg|CF101: orally q12h
186624|NCT01235234|E3|Reported Event|Placebo|CF101: orally q12h
186625|NCT01235234|E2|Reported Event|CF101 1 mg|CF101: orally q12h
186626|NCT01235234|E1|Reported Event|CF101 0.1 mg|CF101: orally q12h
186627|NCT01235195|B1|Baseline|Entire Study Population|Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
186628|NCT01235195|P2|Participant Flow|Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule|Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
186629|NCT01235195|P1|Participant Flow|Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet|Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
186630|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186631|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186632|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186633|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186634|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186635|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186636|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186637|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186638|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186639|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186640|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186641|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186642|NCT01235195|E2|Reported Event|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
186643|NCT01235195|E1|Reported Event|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
186644|NCT01234922|B5|Baseline|Total|Total of all reporting groups
186645|NCT01234922|B4|Baseline|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
186646|NCT01234922|B3|Baseline|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
186647|NCT01234922|B2|Baseline|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
186648|NCT01234922|B1|Baseline|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
186656|NCT01234922|O1|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
186657|NCT01234922|E4|Reported Event|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
186658|NCT01234922|E3|Reported Event|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
186659|NCT01234922|E2|Reported Event|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
186660|NCT01234922|E1|Reported Event|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
186661|NCT01234883|B3|Baseline|Total|Total of all reporting groups
186662|NCT01234883|B2|Baseline|0.9% Saline|saline: IV saline solution dosed as clinically indicated for rehydration
186663|NCT01234883|B1|Baseline|Plasma-Lyte A|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
186664|NCT01234883|P2|Participant Flow|Saline|0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
186665|NCT01234883|P1|Participant Flow|Multiple Electrolyte Solution|Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
186666|NCT01234883|O2|Outcome|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
186667|NCT01234883|O1|Outcome|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
186668|NCT01234883|E2|Reported Event|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
186669|NCT01234883|E1|Reported Event|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
186670|NCT01234870|B1|Baseline|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
186671|NCT01234870|P1|Participant Flow|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
186672|NCT01234870|O1|Outcome|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
186673|NCT01234870|O1|Outcome|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
186674|NCT01234870|E1|Reported Event|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
186675|NCT01234831|B3|Baseline|Total|Total of all reporting groups
186676|NCT01234831|B2|Baseline|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
186677|NCT01234831|B1|Baseline|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186678|NCT01234831|P2|Participant Flow|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
186679|NCT01234831|P1|Participant Flow|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186680|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186681|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186682|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186683|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
186684|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
186685|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
186686|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
186687|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
186688|NCT01234831|E1|Reported Event|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
186689|NCT01234714|B1|Baseline|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
186975|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186690|NCT01234714|P1|Participant Flow|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
186691|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186692|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186693|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186694|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186695|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186696|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186697|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186698|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186699|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186700|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186701|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186702|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
186703|NCT01234714|O2|Outcome|Clavien-Dindo Grade ≥IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~These are typically life-threatening complication (including CNS complications) requiring ICU management.~Grade IVa: single organ dysfunction (including dialysis)~Grade IVb: multi-organ dysfunction"
186704|NCT01234714|O1|Outcome|Clavien-Dindo Grade <IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification.~Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.~Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.~Blood transfusions and total parenteral nutrition are also included.~Grade III:Requiring surgical, endoscopic or radiological intervention"
186705|NCT01234714|E1|Reported Event|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
186706|NCT01234675|B1|Baseline|All Study Participants|2 treatment period, with each period 6 weeks and 7 day washout period Milnacipran in treatment period 1, Placebo in treatment period 2 Placebo treatment in Period 1, and Milnacipran in Period 2
186707|NCT01234675|P2|Participant Flow|Milnacipran Then Placebo|50 mg BiD maintenance dose
186708|NCT01234675|P1|Participant Flow|Placebo Then Milnacipran|50 mg BiD maintenance dose
186709|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
186710|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
186711|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
186712|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
186713|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
186714|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
186715|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
186716|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
186717|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
186718|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
186719|NCT01234675|E2|Reported Event|Placebo|Drug: Placebo 50 mg, twice daily for 4 weeks.
186720|NCT01234675|E1|Reported Event|Milnacipran|Drug: milnacipran, 50 mg twice daily for 4 weeks.
186721|NCT01234337|B3|Baseline|Total|Total of all reporting groups
186722|NCT01234337|B2|Baseline|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186723|NCT01234337|B1|Baseline|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186724|NCT01234337|P2|Participant Flow|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186976|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186725|NCT01234337|P1|Participant Flow|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186726|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186727|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186728|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186729|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186730|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186731|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186732|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186733|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186734|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186735|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186736|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186780|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186977|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
188256|NCT01229371|E4|Reported Event|Subjects >60 Years - CSL HA Antigen|
186737|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186738|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186739|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186740|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186741|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186742|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186743|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186744|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186745|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186746|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186747|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186748|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186749|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186750|NCT01234337|E2|Reported Event|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
186751|NCT01234337|E1|Reported Event|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
186752|NCT01233999|B1|Baseline|Botox|single-drug dosage comparison cross-over study
186753|NCT01233999|P1|Participant Flow|Botox|Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
186754|NCT01233999|O1|Outcome|Botox|single-drug dosage comparison cross-over study
186755|NCT01233999|E1|Reported Event|Botox|single-drug dosage comparison cross-over study
186756|NCT01233921|B3|Baseline|Total|Total of all reporting groups
186757|NCT01233921|B2|Baseline|Arm II (no Palifermin)|Patients do not receive palifermin.
186758|NCT01233921|B1|Baseline|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
186759|NCT01233921|P2|Participant Flow|Arm II (no Palifermin)|Patients do not receive palifermin.
186760|NCT01233921|P1|Participant Flow|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
186761|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
186762|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
186763|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
186764|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
186765|NCT01233921|E2|Reported Event|Arm II (no Palifermin)|Patients do not receive palifermin.
186766|NCT01233921|E1|Reported Event|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
186767|NCT01233869|B5|Baseline|Total|Total of all reporting groups
186768|NCT01233869|B4|Baseline|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186769|NCT01233869|B3|Baseline|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186770|NCT01233869|B2|Baseline|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186771|NCT01233869|B1|Baseline|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186772|NCT01233869|P4|Participant Flow|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186773|NCT01233869|P3|Participant Flow|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186774|NCT01233869|P2|Participant Flow|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186775|NCT01233869|P1|Participant Flow|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186776|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186777|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186778|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186779|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186968|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186781|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186782|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186783|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186784|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186785|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186786|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186787|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186788|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186789|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186790|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186791|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186792|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186793|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186794|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186795|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186796|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186797|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186798|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186799|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186800|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186801|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186969|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186802|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186803|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186804|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186805|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186806|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186807|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186808|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186809|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186810|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186811|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186812|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186813|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186814|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186815|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186816|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186817|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186818|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186819|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186820|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186821|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186822|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186823|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186824|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186825|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186826|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186827|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186828|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186829|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186830|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186831|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186832|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186833|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186834|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186835|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186836|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186837|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186838|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186839|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186840|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186841|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186842|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186843|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186844|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
205011|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
186845|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186846|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186847|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186848|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186849|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186850|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186851|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186852|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186853|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186854|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186855|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186856|NCT01233869|E4|Reported Event|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
186857|NCT01233869|E3|Reported Event|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
186858|NCT01233869|E2|Reported Event|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
186859|NCT01233869|E1|Reported Event|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
186860|NCT01233817|B1|Baseline|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
186861|NCT01233817|P1|Participant Flow|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
186862|NCT01233817|O1|Outcome|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
186863|NCT01233817|E1|Reported Event|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
186864|NCT01233726|B4|Baseline|Total|Total of all reporting groups
186865|NCT01233726|B3|Baseline|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186866|NCT01233726|B2|Baseline|ISOSOURCE PROTEIN FIBRE|"Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186867|NCT01233726|B1|Baseline|DIABA HP|"Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric."
205365|NCT01178853|P1|Participant Flow|Pitavastatin/Rosuvastatin|
186868|NCT01233726|P3|Participant Flow|GLUCERNA SELECT|"Patients of this group received GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186869|NCT01233726|P2|Participant Flow|ISOSOURCE PROTEIN FIBRE|"Patients of this group received ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186870|NCT01233726|P1|Participant Flow|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
186871|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186872|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186873|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186874|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186875|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186876|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
186877|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186878|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186879|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
186880|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186881|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186882|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
186883|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186884|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186885|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186886|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186887|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186888|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186889|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186890|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186891|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186892|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186893|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186894|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186895|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186896|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186897|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186970|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186898|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186899|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186900|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186901|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186902|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
186903|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
186904|NCT01233726|E3|Reported Event|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg/ day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186905|NCT01233726|E2|Reported Event|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
186906|NCT01233726|E1|Reported Event|DIABA HP|"Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
186907|NCT01233687|B1|Baseline|AMG 102 + Erlotinib|
186908|NCT01233687|P1|Participant Flow|AMG 102 + Erlotinib|
186909|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
186910|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
186911|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
186912|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
186913|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
186914|NCT01233687|E1|Reported Event|AMG 102 + Erlotinib|"Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.~Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%."
186915|NCT01233284|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
186916|NCT01233284|P5|Participant Flow|Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd|Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
186917|NCT01233284|P4|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd|Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
186918|NCT01233284|P3|Participant Flow|Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo|Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
186919|NCT01233284|P2|Participant Flow|Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
186971|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
205366|NCT01178853|O2|Outcome|Warfarin + Rosuvastatin|
186920|NCT01233284|P1|Participant Flow|Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd|Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
186921|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186922|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186923|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186924|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186925|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186926|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186927|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186928|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186929|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186930|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186931|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186932|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186933|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186934|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186935|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186936|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186937|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186938|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186939|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186940|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186941|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186942|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186943|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186944|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186945|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186946|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186947|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186948|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186949|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186950|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186951|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186952|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186953|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186954|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186955|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186956|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186957|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186958|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186959|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186960|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186961|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186962|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186963|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186964|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186965|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186966|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186967|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186979|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186980|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186981|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186982|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186983|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186984|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186985|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186986|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186987|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186988|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186989|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186990|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186991|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186992|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186993|NCT01233284|E4|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186994|NCT01233284|E3|Reported Event|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186995|NCT01233284|E2|Reported Event|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
186996|NCT01233284|E1|Reported Event|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
186997|NCT01233258|B4|Baseline|Total|Total of all reporting groups
186998|NCT01233258|B3|Baseline|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
186999|NCT01233258|B2|Baseline|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
187000|NCT01233258|B1|Baseline|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187001|NCT01233258|P6|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
187002|NCT01233258|P5|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
187003|NCT01233258|P4|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
187004|NCT01233258|P3|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
187005|NCT01233258|P2|Participant Flow|On Demand, BAY 81-8973 Potency First ADJ Then EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
187006|NCT01233258|P1|Participant Flow|On Demand, BAY 81-8973 Potency First EP Then ADJ|Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
187007|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187008|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187009|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187010|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
187059|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187060|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
205367|NCT01178853|O1|Outcome|Warfarin + Pitavastatin|
187011|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
187012|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187013|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
187014|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
187015|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
187016|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
187017|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.
187018|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
187019|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
187020|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
187021|NCT01233258|E1|Reported Event|rFVIII (BAY81-8973) Treatment|Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization
187022|NCT01233232|B4|Baseline|Total|Total of all reporting groups
187023|NCT01233232|B3|Baseline|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187024|NCT01233232|B2|Baseline|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187025|NCT01233232|B1|Baseline|Placebo|4 x placebo capsules, twice daily (bid)
187026|NCT01233232|P3|Participant Flow|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187027|NCT01233232|P2|Participant Flow|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187028|NCT01233232|P1|Participant Flow|Placebo|4 x placebo capsules, twice daily (bid)
187029|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187030|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187031|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187032|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187033|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187034|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187035|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187036|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187037|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187038|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187039|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187040|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187041|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187042|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187043|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187044|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187045|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187046|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187047|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187048|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187049|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187050|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187051|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187052|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187053|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187054|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187055|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187056|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187063|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187064|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187065|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187066|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187067|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187068|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187069|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187070|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187071|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187072|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187073|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187074|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187075|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187076|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
187077|NCT01233232|E3|Reported Event|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
187078|NCT01233232|E2|Reported Event|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
187079|NCT01233232|E1|Reported Event|Placebo|4 x placebo capsules, twice daily (bid)
187080|NCT01233076|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
187081|NCT01233076|P2|Participant Flow|Narafilcon B / Nelfilcon A|Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
187082|NCT01233076|P1|Participant Flow|Nelfilcon A / Narafilcon B|Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
187083|NCT01233076|O2|Outcome|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
187084|NCT01233076|O1|Outcome|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
187085|NCT01233076|E2|Reported Event|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
187086|NCT01233076|E1|Reported Event|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
187087|NCT01232920|B3|Baseline|Total|Total of all reporting groups
187088|NCT01232920|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187089|NCT01232920|B1|Baseline|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187090|NCT01232920|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187091|NCT01232920|P1|Participant Flow|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187092|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187109|NCT01232894|E2|Reported Event|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
187110|NCT01232894|E1|Reported Event|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
187111|NCT01232868|B3|Baseline|Total|Total of all reporting groups
187112|NCT01232868|B2|Baseline|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187093|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187094|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187095|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187096|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187097|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187098|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187099|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187100|NCT01232920|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
187101|NCT01232920|E1|Reported Event|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
187102|NCT01232894|B3|Baseline|Total|Total of all reporting groups
187103|NCT01232894|B2|Baseline|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
187104|NCT01232894|B1|Baseline|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
187105|NCT01232894|P2|Participant Flow|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
187106|NCT01232894|P1|Participant Flow|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
187107|NCT01232894|O2|Outcome|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
187108|NCT01232894|O1|Outcome|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
187113|NCT01232868|B1|Baseline|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187114|NCT01232868|P2|Participant Flow|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187115|NCT01232868|P1|Participant Flow|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187116|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187117|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187118|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187119|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187120|NCT01232868|E2|Reported Event|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187121|NCT01232868|E1|Reported Event|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
187122|NCT01232829|B1|Baseline|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187123|NCT01232829|P1|Participant Flow|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187124|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187125|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187126|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187127|NCT01232829|E1|Reported Event|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
187128|NCT01232790|B1|Baseline|Participants|This is the overall group of trial participants prior to randomization to either of the two crossover arms in the study.
187129|NCT01232790|P2|Participant Flow|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
187130|NCT01232790|P1|Participant Flow|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187131|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
187132|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187133|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
187134|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187135|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
187136|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187137|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187138|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187199|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187200|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187139|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187140|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187141|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187142|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187143|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187144|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187145|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187146|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187147|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187148|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187149|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
187150|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187151|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187152|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187153|NCT01232790|O2|Outcome|Placebo|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187154|NCT01232790|O1|Outcome|Intervention|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187155|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
187156|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187157|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187158|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187159|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187160|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187201|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187202|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187161|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187162|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187163|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
187164|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187165|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
187166|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187167|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
187168|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187169|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
187170|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187171|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and the receives rge commercially available sustained release form of NAC, in each arm the capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187172|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
187173|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
187174|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187175|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
187176|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187177|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
187178|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
187179|NCT01232790|E4|Reported Event|NAC: Second Crossover Follow Up|This group of participants received the active treatment (NAC) on the second day of the crossover study.
187180|NCT01232790|E3|Reported Event|Placebo: Second Crossover Follow Up|This group of participants received the placebo on the second day in the crossover design.
187181|NCT01232790|E2|Reported Event|NAC: First Crossover Follow Up|This group of participants received the active treatment (NAC) on the first day of the crossover study.
187182|NCT01232790|E1|Reported Event|Placebo: First Crossover Follow Up|This group of participants received the placebo on the first day in the crossover design.
187183|NCT01232569|B3|Baseline|Total|Total of all reporting groups
187184|NCT01232569|B2|Baseline|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187185|NCT01232569|B1|Baseline|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187186|NCT01232569|P4|Participant Flow|Tocilizumab Auto-injector - Open-label Extension Period|Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.
187187|NCT01232569|P3|Participant Flow|Tocilizumab Pre-filled Syringe - Open-label Extension Period|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
187188|NCT01232569|P2|Participant Flow|Placebo sc - Double-blind Treatment Period|Patients received placebo sc every 2 weeks for 24 weeks.
187189|NCT01232569|P1|Participant Flow|Tocilizumab 162 mg sc - Double-blind Treatment Period|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187190|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187191|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187192|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187193|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187194|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187195|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187196|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187197|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187198|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187203|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187204|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187205|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187206|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187207|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187208|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187209|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187210|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187211|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187212|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187213|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187214|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187215|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187216|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187217|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187218|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187219|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187220|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187221|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187222|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
187223|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
187224|NCT01232569|E5|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Autoinjector|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
187225|NCT01232569|E4|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
187226|NCT01232569|E3|Reported Event|Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
187227|NCT01232569|E2|Reported Event|Placebo Pre-filled Syringe|Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.
187228|NCT01232569|E1|Reported Event|Tocilizumab Pre-filled Syringe|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).
187229|NCT01232504|B4|Baseline|Total|Total of all reporting groups
187230|NCT01232504|B3|Baseline|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187231|NCT01232504|B2|Baseline|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187232|NCT01232504|B1|Baseline|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187233|NCT01232504|P3|Participant Flow|rhG-CSF Group|subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187234|NCT01232504|P2|Participant Flow|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187235|NCT01232504|P1|Participant Flow|rhGM-CSF Group|subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187236|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187237|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187238|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187239|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187290|NCT01232465|P2|Participant Flow|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
188257|NCT01229371|E3|Reported Event|Subjects >60 Years - AdImmune HA Antigen|
187240|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187241|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187242|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187243|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187244|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187245|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187246|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187247|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187248|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187249|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187250|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187251|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187252|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187253|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187254|NCT01232504|O3|Outcome|rhG-CSF|"5-7μg/kg per day~rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
187255|NCT01232504|O2|Outcome|rhGM-CSF Plus rhG-CSF|"rhGM-CSF and rhG-CSF both at 2-3μg/kg per day~rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
187256|NCT01232504|O1|Outcome|rhGM-CSF|"5-7μg/kg per day~rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
187257|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187258|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187259|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187260|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187261|NCT01232504|O2|Outcome|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187262|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187263|NCT01232504|E3|Reported Event|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187264|NCT01232504|E2|Reported Event|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187265|NCT01232504|E1|Reported Event|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
187266|NCT01232491|B3|Baseline|Total|Total of all reporting groups
187267|NCT01232491|B2|Baseline|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187291|NCT01232465|P1|Participant Flow|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
187268|NCT01232491|B1|Baseline|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187269|NCT01232491|P2|Participant Flow|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187270|NCT01232491|P1|Participant Flow|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187271|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187272|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187273|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187274|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187275|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187276|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187277|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187278|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187279|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187280|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187281|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187282|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187283|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187284|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187285|NCT01232491|E2|Reported Event|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
187286|NCT01232491|E1|Reported Event|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
187287|NCT01232465|B3|Baseline|Total|Total of all reporting groups
187288|NCT01232465|B2|Baseline|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
187289|NCT01232465|B1|Baseline|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
187292|NCT01232465|O2|Outcome|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
187293|NCT01232465|O1|Outcome|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
187294|NCT01232465|E2|Reported Event|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
187295|NCT01232465|E1|Reported Event|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
187296|NCT01232296|B3|Baseline|Total|Total of all reporting groups
187297|NCT01232296|B2|Baseline|Sorafenib|400 mg tablet p.o. b.i.d.
187298|NCT01232296|B1|Baseline|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187299|NCT01232296|P2|Participant Flow|Sorafenib|400 mg tablet p.o. b.i.d.
187300|NCT01232296|P1|Participant Flow|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187301|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187302|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187303|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187304|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
187305|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187306|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
187307|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187308|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
187309|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187310|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
187311|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187312|NCT01232296|E2|Reported Event|Sorafenib|400 mg tablet p.o. b.i.d.
187313|NCT01232296|E1|Reported Event|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
187314|NCT01232283|B3|Baseline|Total|Total of all reporting groups
187315|NCT01232283|B2|Baseline|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
187316|NCT01232283|B1|Baseline|Apremilast|Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187317|NCT01232283|P8|Participant Flow|PBO-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to PBO BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
187318|NCT01232283|P7|Participant Flow|APR-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
187319|NCT01232283|P6|Participant Flow|APR-APR Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
187320|NCT01232283|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time the loss was observed. Those participants who did not lose at least 50% of the PASI response remained on PBO until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received APR 30 mg BID for the remainder of their participation.
187321|NCT01232283|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to PBO BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32)
187322|NCT01232283|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
187323|NCT01232283|P2|Participant Flow|Placebo|Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
187324|NCT01232283|P1|Participant Flow|Apremilast|Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
187325|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
187326|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
187327|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187328|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187329|NCT01232283|O2|Outcome|APR-APR -Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR 30mg BID during the Randomized Withdrawal Phase (Weeks 32-52).
187330|NCT01232283|O1|Outcome|APR-APR Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time this loss was observed. Those participants who did not lose at least 50% of the PASI response from baseline through the Randomized Withdrawal Phase remained on PBO until Week 52.
187331|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
187332|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187333|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
187334|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
187335|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187336|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187337|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
187338|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187339|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187340|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187341|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
187342|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187343|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
187344|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187345|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (weeks 0-16)
187346|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187347|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
187348|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
187349|NCT01232283|E4|Reported Event|APR-Exposure Period: Weeks 0-52|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
187350|NCT01232283|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
187351|NCT01232283|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187352|NCT01232283|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
187353|NCT01232205|B3|Baseline|Total|Total of all reporting groups
187354|NCT01232205|B2|Baseline|Control|
187355|NCT01232205|B1|Baseline|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
187356|NCT01232205|P2|Participant Flow|Control|
187357|NCT01232205|P1|Participant Flow|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
187358|NCT01232205|O2|Outcome|Control|
187359|NCT01232205|O1|Outcome|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
187360|NCT01232205|E2|Reported Event|Control|
187361|NCT01232205|E1|Reported Event|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
187362|NCT01232127|B1|Baseline|All Treated|
187363|NCT01232127|P3|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187364|NCT01232127|P2|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187845|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
187365|NCT01232127|P1|Participant Flow|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187366|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187367|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187368|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187369|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
187370|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187371|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187372|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187373|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187374|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187375|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187376|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187377|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187378|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187379|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
187380|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187381|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187382|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187383|NCT01232127|E3|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
187384|NCT01232127|E2|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187385|NCT01232127|E1|Reported Event|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
187386|NCT01231984|B3|Baseline|Total|Total of all reporting groups
187387|NCT01231984|B2|Baseline|4 mm vs. 12.7 mm|Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
187388|NCT01231984|B1|Baseline|4 mm vs. 8 mm|Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
187389|NCT01231984|P4|Participant Flow|12.7 mm First ( 4 vs.12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
187390|NCT01231984|P3|Participant Flow|4 mm First (4 vs.12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
187391|NCT01231984|P2|Participant Flow|8 mm First (4 vs.8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
187392|NCT01231984|P1|Participant Flow|4 mm First (4 vs.8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
187393|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
187394|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
187395|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
187396|NCT01231984|O2|Outcome|12.7 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
187397|NCT01231984|O1|Outcome|4 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
187398|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
187399|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
187400|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
187401|NCT01231984|O2|Outcome|12 mm Among Those in 4 mm x 12 mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 12mm PN for another 12 weeks.
187402|NCT01231984|O1|Outcome|4 mm Among Those in 12mm x 4mm Arm|Subjects randomized to this study arm first used the 12mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
187403|NCT01231984|O2|Outcome|8 mm Among Those in 4mm x 8mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 8mm PN for another 12 weeks.
187404|NCT01231984|O1|Outcome|4 mm Among Those in 8mm x 4 mm Arm|Subjects randomized to this study arm first used the 8mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
187405|NCT01231984|O2|Outcome|Longer PN First (8mm or 12.7mm)|Subjects in this group first used one of the longer PNs (8 mm or 12 mm PN) for 12 weeks in Period 1, based on the randomization, then switched to the 4mm PN for another 12 weeks in Period 2.
187406|NCT01231984|O1|Outcome|4 mm First|Subjects in this group first used the 4 mm PN for 12 weeks in Period 1, then switched to a longer PN (8 mm or 12 mm PN) for another 12 weeks in Period 2, based on their randomization.
187407|NCT01231984|O2|Outcome|8 mm First (4 vs. 8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
187408|NCT01231984|O1|Outcome|4 mm First (4 vs. 8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
187409|NCT01231984|E3|Reported Event|12.7mm Needle|
187410|NCT01231984|E2|Reported Event|8mm Needle|
187411|NCT01231984|E1|Reported Event|4mm Needle|
187412|NCT01231841|B1|Baseline|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
187413|NCT01231841|P1|Participant Flow|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
187414|NCT01231841|O1|Outcome|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
187415|NCT01231841|E1|Reported Event|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
187416|NCT01231750|B3|Baseline|Total|Total of all reporting groups
187417|NCT01231750|B2|Baseline|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187418|NCT01231750|B1|Baseline|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187419|NCT01231750|P2|Participant Flow|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187420|NCT01231750|P1|Participant Flow|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187421|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187422|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187423|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187424|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187425|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187426|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187427|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187428|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187429|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187430|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187431|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187432|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187433|NCT01231750|E2|Reported Event|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
187434|NCT01231750|E1|Reported Event|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
187435|NCT01231646|B3|Baseline|Total|Total of all reporting groups
187436|NCT01231646|B2|Baseline|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
187437|NCT01231646|B1|Baseline|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
187438|NCT01231646|P2|Participant Flow|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
187439|NCT01231646|P1|Participant Flow|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
187440|NCT01231646|O2|Outcome|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
187441|NCT01231646|O1|Outcome|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
187442|NCT01231646|E2|Reported Event|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
187443|NCT01231646|E1|Reported Event|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
187444|NCT01231607|B6|Baseline|Total|Total of all reporting groups
187445|NCT01231607|B5|Baseline|Placebo|Matching dutasteride placebo and finasteride placebo once daily
187446|NCT01231607|B4|Baseline|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
187447|NCT01231607|B3|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
187448|NCT01231607|B2|Baseline|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
187449|NCT01231607|B1|Baseline|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
187450|NCT01231607|P5|Participant Flow|Placebo|Matching dutasteride placebo and finasteride placebo once daily
187451|NCT01231607|P4|Participant Flow|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
187452|NCT01231607|P3|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
187453|NCT01231607|P2|Participant Flow|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
187454|NCT01231607|P1|Participant Flow|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
187455|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187456|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187457|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187458|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187459|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187460|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187461|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187462|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187463|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187464|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187465|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187466|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187467|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187468|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187469|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187470|NCT01231607|O3|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187471|NCT01231607|O2|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187472|NCT01231607|O1|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187473|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187474|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187475|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187476|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187477|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187478|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187479|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187480|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187481|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187482|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187483|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187484|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187485|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187486|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187487|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187488|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187489|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187490|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187491|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187492|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187493|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187494|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187495|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187496|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187497|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187498|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187499|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187846|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
187500|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187501|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187502|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187503|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187504|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187505|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187506|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187507|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187508|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187509|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187510|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187511|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187512|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187513|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187514|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187515|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187516|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187517|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187518|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187519|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187520|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187521|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187522|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187523|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187524|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187525|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187526|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187527|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187528|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187529|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187530|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187531|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187532|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187533|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
187534|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187847|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
187535|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187536|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
187537|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
187538|NCT01231607|E5|Reported Event|Placebo|Matching dutasteride placebo and finasteride placebo once daily
187539|NCT01231607|E4|Reported Event|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
187540|NCT01231607|E3|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
187541|NCT01231607|E2|Reported Event|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
187542|NCT01231607|E1|Reported Event|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
187543|NCT01231581|B3|Baseline|Total|Total of all reporting groups
187544|NCT01231581|B2|Baseline|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187545|NCT01231581|B1|Baseline|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187546|NCT01231581|P2|Participant Flow|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187547|NCT01231581|P1|Participant Flow|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187548|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187549|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187550|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187551|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187552|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187553|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187554|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187848|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
187849|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
187555|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187556|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187557|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187558|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187559|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187560|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187561|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187562|NCT01231581|E2|Reported Event|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187563|NCT01231581|E1|Reported Event|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
187564|NCT01231516|B3|Baseline|Total|Total of all reporting groups
187565|NCT01231516|B2|Baseline|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187566|NCT01231516|B1|Baseline|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187567|NCT01231516|P2|Participant Flow|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187568|NCT01231516|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187569|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
187850|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
187851|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
205368|NCT01178853|E2|Reported Event|Warfarin + Rosuvastatin|
187570|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187571|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187572|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187573|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187574|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187575|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187576|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187577|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187578|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187579|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187580|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187581|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187582|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187583|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187584|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187585|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
187852|NCT01231373|E4|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam target therapeutic dose
187586|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
187587|NCT01231516|E2|Reported Event|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available.
187588|NCT01231516|E1|Reported Event|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
187589|NCT01231503|B9|Baseline|Total|Total of all reporting groups
187590|NCT01231503|B8|Baseline|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187591|NCT01231503|B7|Baseline|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187592|NCT01231503|B6|Baseline|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187593|NCT01231503|B5|Baseline|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187594|NCT01231503|B4|Baseline|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187595|NCT01231503|B3|Baseline|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187596|NCT01231503|B2|Baseline|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187853|NCT01231373|E3|Reported Event|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam, 0.5% lower experimental dose
187854|NCT01231373|E2|Reported Event|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125% active placebo
187597|NCT01231503|B1|Baseline|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187598|NCT01231503|P8|Participant Flow|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187599|NCT01231503|P7|Participant Flow|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187600|NCT01231503|P6|Participant Flow|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187601|NCT01231503|P5|Participant Flow|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187602|NCT01231503|P4|Participant Flow|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187603|NCT01231503|P3|Participant Flow|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187604|NCT01231503|P2|Participant Flow|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187605|NCT01231503|P1|Participant Flow|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
205369|NCT01178853|E1|Reported Event|Warfarin + Pitavastatin|
187606|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187607|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187608|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187609|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187610|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187611|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187612|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187613|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187614|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187855|NCT01231373|E1|Reported Event|Vehicle|Vehicle: Injection of vehicle comparator
187615|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187616|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187617|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187618|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187619|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187620|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187621|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187622|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187623|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187856|NCT01231334|B3|Baseline|Total|Total of all reporting groups
187624|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187625|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187626|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187627|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187628|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187629|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187630|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187631|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187632|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187995|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187633|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187634|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187635|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187636|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187637|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187638|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187639|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187640|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187641|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187996|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187642|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187643|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187644|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187645|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187646|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187647|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187648|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187649|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187650|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187997|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187651|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187652|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187653|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187654|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187655|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187656|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187657|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187658|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187659|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187998|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187660|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187661|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187662|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187663|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187664|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187665|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187666|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187667|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187668|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188258|NCT01229371|E2|Reported Event|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
187669|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187670|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187671|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187672|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187673|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187674|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187675|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187676|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187677|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187999|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187678|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187679|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187680|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187681|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187682|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187683|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187684|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187685|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187686|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188000|NCT01230710|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187687|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187688|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187689|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187690|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187691|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187692|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187693|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187694|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187695|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188001|NCT01230502|B4|Baseline|Total|Total of all reporting groups
187696|NCT01231503|O2|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187697|NCT01231503|O1|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187698|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187699|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187700|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187701|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187702|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187703|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187704|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188259|NCT01229371|E1|Reported Event|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
187705|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187706|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187707|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187708|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187709|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187710|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187711|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187712|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187713|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188260|NCT01229228|B6|Baseline|Total|Total of all reporting groups
188261|NCT01229228|B5|Baseline|Placebo|
187714|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187715|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187716|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187717|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187718|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187719|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187720|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187721|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187722|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188262|NCT01229228|B4|Baseline|Naprosyn 500 mg|
188263|NCT01229228|B3|Baseline|Naprosyn 250 mg|
187723|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187724|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187725|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187726|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187727|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187728|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187729|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187730|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187731|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188264|NCT01229228|B2|Baseline|Naproxen Test (Upper Dose)|
188265|NCT01229228|B1|Baseline|Naproxen Test (Lower Dose)|
187732|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187733|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187734|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187735|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187736|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187737|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187738|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187739|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187740|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188266|NCT01229228|P5|Participant Flow|Placebo|
188267|NCT01229228|P4|Participant Flow|Naprosyn 500 mg|
187741|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187742|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187743|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187744|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187745|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187746|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187747|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187748|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187749|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188268|NCT01229228|P3|Participant Flow|Naprosyn 250 mg|
187750|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187751|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187752|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187753|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187754|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187755|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187756|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187757|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187758|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188269|NCT01229228|P2|Participant Flow|Naproxen Test (Upper Dose)|
188270|NCT01229228|P1|Participant Flow|Naproxen Test (Lower Dose)|
187759|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187760|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187761|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187762|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187763|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187764|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187765|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187766|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187767|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188271|NCT01229228|O5|Outcome|Placebo|
188272|NCT01229228|O4|Outcome|Naprosyn 500 mg|
187768|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187769|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187770|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187771|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187772|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187773|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187774|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187775|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187776|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188273|NCT01229228|O3|Outcome|Naprosyn 250 mg|
187777|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187778|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187779|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187780|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187781|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187782|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187783|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187784|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187785|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188274|NCT01229228|O2|Outcome|Naproxen Test (Upper Dose)|400-mg (2 x 200-mg)
187786|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187787|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187788|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187789|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187790|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187791|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187792|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187793|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187794|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188275|NCT01229228|O1|Outcome|Naproxen Test (Lower Dose)|200-mg single dose
188276|NCT01229228|E5|Reported Event|Placebo|
187795|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187796|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187797|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187798|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187799|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187800|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187801|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187802|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187803|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188277|NCT01229228|E4|Reported Event|Naprosyn 500 mg|
188278|NCT01229228|E3|Reported Event|Naprosyn 250 mg|
187804|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187805|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187806|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187807|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187808|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187809|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187810|NCT01231503|E8|Reported Event|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187811|NCT01231503|E7|Reported Event|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187812|NCT01231503|E6|Reported Event|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
188279|NCT01229228|E2|Reported Event|Naproxen Test (Upper Dose)|
187813|NCT01231503|E5|Reported Event|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187814|NCT01231503|E4|Reported Event|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187815|NCT01231503|E3|Reported Event|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187816|NCT01231503|E2|Reported Event|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187817|NCT01231503|E1|Reported Event|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
187818|NCT01231464|B3|Baseline|Total|Total of all reporting groups
187819|NCT01231464|B2|Baseline|Placebo|Matching Vehicle Placebo Nasal Spray QD
187820|NCT01231464|B1|Baseline|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
187821|NCT01231464|P2|Participant Flow|Placebo|Matching Vehicle Placebo Nasal Spray QD
187822|NCT01231464|P1|Participant Flow|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
187823|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
187824|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mg) once daily (QD)
187825|NCT01231464|O2|Outcome|Placebo|Matching Vehicle placebo nasal spray QD
187826|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
187827|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
187828|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
187829|NCT01231464|E2|Reported Event|Placebo|Matching Vehicle Placebo Nasal Spray QD
187830|NCT01231464|E1|Reported Event|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
187831|NCT01231373|B5|Baseline|Total|Total of all reporting groups
187832|NCT01231373|B4|Baseline|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam therapeutic dose
187833|NCT01231373|B3|Baseline|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam lower experimental dose
187834|NCT01231373|B2|Baseline|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam active placebo
187835|NCT01231373|B1|Baseline|Vehicle|Vehicle: Injection of vehicle comparator
187836|NCT01231373|P4|Participant Flow|Polidocanol Injectable Foam, 1.0%|1.0% polidocanol foam injection
187837|NCT01231373|P3|Participant Flow|Polidocanol Injectable Foam, 0.5%|lower experimental polidocanol dose
187838|NCT01231373|P2|Participant Flow|Polidocanol Injectable Foam, 0.125%|active placebo for blinding of therapeutic polidocanol dose
187839|NCT01231373|P1|Participant Flow|Vehicle|Vehicle: Injection of vehicle comparator
187840|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0% experimental dose
187841|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
187842|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
187843|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
187844|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, experimental dose 1.0%
188280|NCT01229228|E1|Reported Event|Naproxen Test (Lower Dose)|
187857|NCT01231334|B2|Baseline|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187858|NCT01231334|B1|Baseline|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187859|NCT01231334|P2|Participant Flow|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187860|NCT01231334|P1|Participant Flow|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187861|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187862|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187863|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187864|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187865|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187866|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187867|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187868|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187869|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187870|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187871|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187872|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187873|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187874|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187875|NCT01231334|E2|Reported Event|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
187876|NCT01231334|E1|Reported Event|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
187877|NCT01231321|B1|Baseline|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
187878|NCT01231321|P1|Participant Flow|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
187879|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
187880|NCT01231321|O2|Outcome|Above Reference Range|Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter
187881|NCT01231321|O1|Outcome|Below Reference Range|Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
187882|NCT01231321|O2|Outcome|Above Reference Range|Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter
187883|NCT01231321|O1|Outcome|Below Reference Range|Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
187884|NCT01231321|O2|Outcome|Change From Abnormal to Normal|Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks
187885|NCT01231321|O1|Outcome|Change From Normal to Abnormal|Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
187886|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
187887|NCT01231321|E1|Reported Event|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
187888|NCT01231230|B1|Baseline|All Study Participants|participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
187889|NCT01231230|P1|Participant Flow|All Study Groups|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
187890|NCT01231230|O4|Outcome|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
187891|NCT01231230|O3|Outcome|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
187892|NCT01231230|O2|Outcome|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
187893|NCT01231230|O1|Outcome|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
187894|NCT01231230|E4|Reported Event|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
187895|NCT01231230|E3|Reported Event|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
187896|NCT01231230|E2|Reported Event|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
187897|NCT01231230|E1|Reported Event|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
187898|NCT01230892|B3|Baseline|Total|Total of all reporting groups
187899|NCT01230892|B2|Baseline|Atenolol|Atenolol: 100 mg PO qday
187900|NCT01230892|B1|Baseline|Nebivolol|Nebivolol: 10 mg PO qday
187901|NCT01230892|P2|Participant Flow|Atenolol|Atenolol: 100 mg PO qday
187902|NCT01230892|P1|Participant Flow|Nebivolol|Nebivolol: 10 mg PO qday
187903|NCT01230892|O2|Outcome|Atenolol|Atenolol: 100 mg PO qday
187904|NCT01230892|O1|Outcome|Nebivolol|Nebivolol: 10 mg PO qday
187905|NCT01230892|E2|Reported Event|Atenolol|Atenolol: 100 mg PO qday
187906|NCT01230892|E1|Reported Event|Nebivolol|Nebivolol: 10 mg PO qday
187907|NCT01230827|B5|Baseline|Total|Total of all reporting groups
187908|NCT01230827|B4|Baseline|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
187909|NCT01230827|B3|Baseline|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
187910|NCT01230827|B2|Baseline|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
187911|NCT01230827|B1|Baseline|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
187912|NCT01230827|P4|Participant Flow|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
187913|NCT01230827|P3|Participant Flow|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
187914|NCT01230827|P2|Participant Flow|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
187915|NCT01230827|P1|Participant Flow|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
187916|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187917|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187918|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187944|NCT01230788|P1|Participant Flow|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
188281|NCT01229176|B9|Baseline|Total|Total of all reporting groups
205370|NCT01178827|B4|Baseline|Total|Total of all reporting groups
187919|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187920|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187921|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187922|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187923|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
187924|NCT01230827|E4|Reported Event|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
187925|NCT01230827|E3|Reported Event|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
187926|NCT01230827|E2|Reported Event|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
187927|NCT01230827|E1|Reported Event|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
187928|NCT01230814|B3|Baseline|Total|Total of all reporting groups
187929|NCT01230814|B2|Baseline|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187930|NCT01230814|B1|Baseline|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187931|NCT01230814|P2|Participant Flow|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187932|NCT01230814|P1|Participant Flow|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187933|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187934|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187935|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187936|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187937|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187938|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187939|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187940|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187941|NCT01230814|E2|Reported Event|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
187942|NCT01230814|E1|Reported Event|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
187943|NCT01230788|B1|Baseline|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187994|NCT01230710|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
187945|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187946|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187947|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187948|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187949|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187950|NCT01230788|E1|Reported Event|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
187951|NCT01230749|B5|Baseline|Total|Total of all reporting groups
187952|NCT01230749|B4|Baseline|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187953|NCT01230749|B3|Baseline|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187954|NCT01230749|B2|Baseline|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187955|NCT01230749|B1|Baseline|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
187956|NCT01230749|P4|Participant Flow|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187957|NCT01230749|P3|Participant Flow|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187958|NCT01230749|P2|Participant Flow|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187959|NCT01230749|P1|Participant Flow|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
187960|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187961|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187962|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187963|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187964|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187965|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187966|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187967|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187968|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187969|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187970|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187971|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187972|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187973|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187974|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187975|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187976|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187977|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187978|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187979|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187980|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187981|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187982|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187983|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187984|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187985|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
187986|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187987|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187988|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187989|NCT01230749|E4|Reported Event|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
187990|NCT01230749|E3|Reported Event|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
187991|NCT01230749|E2|Reported Event|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
187992|NCT01230749|E1|Reported Event|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
187993|NCT01230710|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
188002|NCT01230502|B3|Baseline|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
188003|NCT01230502|B2|Baseline|Group 2 Donor Specific Regulation DSR +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
188004|NCT01230502|B1|Baseline|Group 3: Donor Specific Regulation DSR -, Standard of Care|"Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
188005|NCT01230502|P3|Participant Flow|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
188006|NCT01230502|P2|Participant Flow|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
188007|NCT01230502|P1|Participant Flow|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
188008|NCT01230502|O3|Outcome|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
188009|NCT01230502|O2|Outcome|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
188010|NCT01230502|O1|Outcome|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
188415|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses - Binocular Measurements
188011|NCT01230502|O3|Outcome|Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
188012|NCT01230502|O2|Outcome|Group 2 DSR (+); Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
188013|NCT01230502|O1|Outcome|Group 3: DSR (-), Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
188014|NCT01230502|E3|Reported Event|Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy|"Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
188015|NCT01230502|E2|Reported Event|Group 2 DSR (Donor Specific Regulation) (+); Standard of Care|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
188016|NCT01230502|E1|Reported Event|Group 3: DSR (Donor Specific Regulation) (-), Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
188017|NCT01230307|B3|Baseline|Total|Total of all reporting groups
188018|NCT01230307|B2|Baseline|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188019|NCT01230307|B1|Baseline|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188020|NCT01230307|P2|Participant Flow|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188021|NCT01230307|P1|Participant Flow|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188022|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188023|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188024|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188025|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188026|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
205446|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
188027|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188028|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188029|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188030|NCT01230307|E2|Reported Event|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
188031|NCT01230307|E1|Reported Event|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
188032|NCT01230060|B1|Baseline|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
188033|NCT01230060|P1|Participant Flow|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
188034|NCT01230060|O1|Outcome|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
188035|NCT01230060|E1|Reported Event|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
188036|NCT01230021|B1|Baseline|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188037|NCT01230021|P1|Participant Flow|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188038|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188039|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188040|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188041|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188042|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188043|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188044|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188045|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188046|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188114|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188047|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188048|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188049|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188050|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188051|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188052|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188053|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188054|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188055|NCT01230021|E1|Reported Event|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
188056|NCT01229943|B3|Baseline|Total|Total of all reporting groups
188057|NCT01229943|B2|Baseline|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188058|NCT01229943|B1|Baseline|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188059|NCT01229943|P2|Participant Flow|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188060|NCT01229943|P1|Participant Flow|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188061|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
188062|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
188063|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
188064|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
188065|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188066|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
188282|NCT01229176|B8|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188067|NCT01229943|E2|Reported Event|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
188068|NCT01229943|E1|Reported Event|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
188069|NCT01229891|B4|Baseline|Total|Total of all reporting groups
188070|NCT01229891|B3|Baseline|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
188071|NCT01229891|B2|Baseline|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
188072|NCT01229891|B1|Baseline|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
188073|NCT01229891|P3|Participant Flow|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
188074|NCT01229891|P2|Participant Flow|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
188075|NCT01229891|P1|Participant Flow|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
188076|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188077|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188078|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188079|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188080|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188081|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188082|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188083|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188084|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188085|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188086|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188087|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188088|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188089|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188090|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188091|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188092|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188093|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188094|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188095|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188096|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188097|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
188098|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
188099|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
188100|NCT01229891|E3|Reported Event|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
188101|NCT01229891|E2|Reported Event|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
188102|NCT01229891|E1|Reported Event|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
188103|NCT01229735|B3|Baseline|Total Title|
188104|NCT01229735|B2|Baseline|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188105|NCT01229735|B1|Baseline|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188106|NCT01229735|P2|Participant Flow|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188107|NCT01229735|P1|Participant Flow|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188108|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188109|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188110|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188111|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188112|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188113|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188115|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188116|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188117|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188118|NCT01229735|E2|Reported Event|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
188119|NCT01229735|E1|Reported Event|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
188120|NCT01229722|B3|Baseline|Total|Total of all reporting groups
188121|NCT01229722|B2|Baseline|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
188122|NCT01229722|B1|Baseline|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
188123|NCT01229722|P2|Participant Flow|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
188124|NCT01229722|P1|Participant Flow|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
188125|NCT01229722|O2|Outcome|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
188126|NCT01229722|O1|Outcome|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
188127|NCT01229722|E2|Reported Event|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
188160|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
205447|NCT01178528|O1|Outcome|Ivabradine|7.5 mg b.i.d.
188128|NCT01229722|E1|Reported Event|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
188129|NCT01229527|B4|Baseline|Total|Total of all reporting groups
188130|NCT01229527|B3|Baseline|Meperidine|
188131|NCT01229527|B2|Baseline|Remifentanil RS2|
188132|NCT01229527|B1|Baseline|Remifentanil RS1|
188133|NCT01229527|P3|Participant Flow|Meperidine|
188134|NCT01229527|P2|Participant Flow|Remifentanil RS2|
188135|NCT01229527|P1|Participant Flow|Remifentanil RS1|
188136|NCT01229527|O3|Outcome|Meperidine|
188137|NCT01229527|O2|Outcome|Remifentanil RS2|
188138|NCT01229527|O1|Outcome|Remifentanil RS1|
188139|NCT01229527|O3|Outcome|Meperidine|
188140|NCT01229527|O2|Outcome|Remifentanil RS2|
188141|NCT01229527|O1|Outcome|Remifentanil RS1|
188142|NCT01229527|E3|Reported Event|Meperidine|
188143|NCT01229527|E2|Reported Event|Remifentanil RS2|
188144|NCT01229527|E1|Reported Event|Remifentanil RS1|
188145|NCT01229462|B3|Baseline|Total|Total of all reporting groups
188146|NCT01229462|B2|Baseline|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188147|NCT01229462|B1|Baseline|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188148|NCT01229462|P2|Participant Flow|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188149|NCT01229462|P1|Participant Flow|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188150|NCT01229462|O2|Outcome|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188151|NCT01229462|O1|Outcome|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188152|NCT01229462|E2|Reported Event|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188153|NCT01229462|E1|Reported Event|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
188154|NCT01229436|B1|Baseline|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188155|NCT01229436|P1|Participant Flow|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188156|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188157|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188158|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188159|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188245|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
188161|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188162|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188163|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188164|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188165|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188166|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188167|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188168|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188169|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188170|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188171|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188172|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188173|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188174|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188175|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188246|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
188247|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
188248|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
188176|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188177|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188178|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188179|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188180|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188181|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188182|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188183|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188184|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188185|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188186|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188187|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188188|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188189|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188190|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188249|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
188250|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
205785|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
188191|NCT01229436|E1|Reported Event|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
188192|NCT01229423|B1|Baseline|LATISSE®|bimatoprost 0.03% (LATISSE®)
188193|NCT01229423|P1|Participant Flow|LATISSE®|bimatoprost 0.03% (LATISSE®)
188194|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188195|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188196|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188197|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188198|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188199|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
188200|NCT01229423|E1|Reported Event|LATISSE®|bimatoprost 0.03% (LATISSE®)
188201|NCT01229410|B3|Baseline|Total|Total of all reporting groups
188202|NCT01229410|B2|Baseline|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188203|NCT01229410|B1|Baseline|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188204|NCT01229410|P2|Participant Flow|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188205|NCT01229410|P1|Participant Flow|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188206|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188207|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188208|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188209|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188210|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188211|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188212|NCT01229410|E2|Reported Event|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188213|NCT01229410|E1|Reported Event|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
188214|NCT01229397|B3|Baseline|Total|Total of all reporting groups
188215|NCT01229397|B2|Baseline|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
188216|NCT01229397|B1|Baseline|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
188217|NCT01229397|P2|Participant Flow|Inflexal V 0.5 mL x 1|"1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:~15 μg HA antigen of A/California/7/2009 (H1N1)-like virus~15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~15 μg HA antigen of B/Brisbane/60/2008-like virus"
188218|NCT01229397|P1|Participant Flow|Inflexal V 0.25 mL x 2|"2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:~7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus~7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~7.5 μg HA antigen of B/Brisbane/60/2008-like virus"
188219|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
188220|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
188221|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
188222|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
188223|NCT01229397|O3|Outcome|Inflexal V 0.5 mL x 1|
188224|NCT01229397|O2|Outcome|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
188225|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
188226|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
188227|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
188228|NCT01229397|E3|Reported Event|Inflexal V 0.5 mL x 1|
188229|NCT01229397|E2|Reported Event|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
188230|NCT01229397|E1|Reported Event|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
188231|NCT01229371|B5|Baseline|Total|Total of all reporting groups
188232|NCT01229371|B4|Baseline|Subjects >60 Years - CSL HA Antigen|
188233|NCT01229371|B3|Baseline|Subjects >60 Years - AdImmune HA Antigen|
188234|NCT01229371|B2|Baseline|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
188235|NCT01229371|B1|Baseline|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
188236|NCT01229371|P4|Participant Flow|Subjects >60 Years - CSL HA Antigen|
188237|NCT01229371|P3|Participant Flow|Subjects >60 Years - AdImmune HA Antigen|
188238|NCT01229371|P2|Participant Flow|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
188239|NCT01229371|P1|Participant Flow|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
188240|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
188241|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
188242|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
188243|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
188244|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
188283|NCT01229176|B7|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188284|NCT01229176|B6|Baseline|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188285|NCT01229176|B5|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188286|NCT01229176|B4|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188287|NCT01229176|B3|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188288|NCT01229176|B2|Baseline|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188289|NCT01229176|B1|Baseline|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188290|NCT01229176|P8|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188291|NCT01229176|P7|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188292|NCT01229176|P6|Participant Flow|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188293|NCT01229176|P5|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188294|NCT01229176|P4|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188295|NCT01229176|P3|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188296|NCT01229176|P2|Participant Flow|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188297|NCT01229176|P1|Participant Flow|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188298|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188299|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188300|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188301|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188302|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188303|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188304|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188305|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188306|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188307|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188308|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188309|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188310|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188311|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188312|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188313|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188314|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188315|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188316|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188317|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188318|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188319|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188320|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188321|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188322|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188323|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188324|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188325|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188326|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188327|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188328|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188329|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188330|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188331|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188332|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188333|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188414|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
188334|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188335|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188336|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188337|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188338|NCT01229176|E8|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
188339|NCT01229176|E7|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
188340|NCT01229176|E6|Reported Event|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
188341|NCT01229176|E5|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188342|NCT01229176|E4|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
188343|NCT01229176|E3|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
188344|NCT01229176|E2|Reported Event|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
188345|NCT01229176|E1|Reported Event|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
188346|NCT01229150|B5|Baseline|Total|Total of all reporting groups
188347|NCT01229150|B4|Baseline|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
188348|NCT01229150|B3|Baseline|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
188349|NCT01229150|B2|Baseline|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
188350|NCT01229150|B1|Baseline|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
188351|NCT01229150|P4|Participant Flow|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
188352|NCT01229150|P3|Participant Flow|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
188353|NCT01229150|P2|Participant Flow|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
188354|NCT01229150|P1|Participant Flow|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
188355|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
188356|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
188357|NCT01229150|O1|Outcome|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
188358|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
188359|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
188360|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
188361|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
188362|NCT01229150|E3|Reported Event|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
188363|NCT01229150|E2|Reported Event|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
188364|NCT01229150|E1|Reported Event|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
188365|NCT01228968|B1|Baseline|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188366|NCT01228968|P1|Participant Flow|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188367|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188368|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188369|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188370|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188371|NCT01228968|E1|Reported Event|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
188372|NCT01228929|B4|Baseline|Total|Total of all reporting groups
188373|NCT01228929|B3|Baseline|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
188374|NCT01228929|B2|Baseline|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
188375|NCT01228929|B1|Baseline|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
188376|NCT01228929|P3|Participant Flow|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
188377|NCT01228929|P2|Participant Flow|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
188378|NCT01228929|P1|Participant Flow|Normal|Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
188379|NCT01228929|O3|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
188380|NCT01228929|O2|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
188381|NCT01228929|O1|Outcome|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
188382|NCT01228929|E3|Reported Event|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
188383|NCT01228929|E2|Reported Event|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
188384|NCT01228929|E1|Reported Event|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
188385|NCT01228747|B3|Baseline|Total|Total of all reporting groups
188386|NCT01228747|B2|Baseline|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188387|NCT01228747|B1|Baseline|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily"
188388|NCT01228747|P2|Participant Flow|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188389|NCT01228747|P1|Participant Flow|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188390|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188391|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188392|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188393|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188394|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188395|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188396|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188397|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188398|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188399|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188400|NCT01228747|E2|Reported Event|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
188401|NCT01228747|E1|Reported Event|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
188402|NCT01228591|B1|Baseline|All Subjects|Subjects who were randomized and successfully completed the study.
188403|NCT01228591|P2|Participant Flow|Acuvue Advance/ Acuvue Advance Plus|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
188404|NCT01228591|P1|Participant Flow|Acuvue Advance Plus/ Acuvue Advance|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
188405|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
188406|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
188407|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
188408|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
188409|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
188410|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
188411|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
188412|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
188413|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
188416|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses-Binocular measurements
188417|NCT01228591|E2|Reported Event|Acuvue Advance|Acuvue Advance contact lenses
188418|NCT01228591|E1|Reported Event|Acuvue Advance Plus|Acuvue Advance Plus contact lenses
188419|NCT01228435|B3|Baseline|Total|Total of all reporting groups
188420|NCT01228435|B2|Baseline|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
188421|NCT01228435|B1|Baseline|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
188422|NCT01228435|P2|Participant Flow|ALK-inhibitor Pre-treated|Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
188423|NCT01228435|P1|Participant Flow|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
188424|NCT01228435|O2|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had receieved prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
188425|NCT01228435|O1|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
188426|NCT01228435|E2|Reported Event|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
188427|NCT01228435|E1|Reported Event|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
188428|NCT01228175|B3|Baseline|Total|Total of all reporting groups
188429|NCT01228175|B2|Baseline|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
188430|NCT01228175|B1|Baseline|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
188431|NCT01228175|P2|Participant Flow|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
188432|NCT01228175|P1|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
188433|NCT01228175|O2|Outcome|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
188434|NCT01228175|O1|Outcome|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
188435|NCT01228175|E2|Reported Event|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
188436|NCT01228175|E1|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
188437|NCT01228084|B1|Baseline|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188438|NCT01228084|P1|Participant Flow|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188439|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188440|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188441|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188442|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188443|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188444|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188445|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188446|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
188447|NCT01228084|E1|Reported Event|Sulpforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic
188448|NCT01228071|B1|Baseline|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188449|NCT01228071|P1|Participant Flow|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188450|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188451|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188452|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188453|NCT01228071|E1|Reported Event|EN3350 (Testosterone Gel 2%)|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
188454|NCT01228019|B1|Baseline|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188455|NCT01228019|P1|Participant Flow|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188456|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188457|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188458|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188459|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188460|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188461|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188462|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188463|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188464|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188465|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188466|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188467|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
188468|NCT01228019|E1|Reported Event|ALL PARTICIPANTS|
188469|NCT01227993|B1|Baseline|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188470|NCT01227993|P1|Participant Flow|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188471|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188472|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188473|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188474|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188475|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188476|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188477|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188478|NCT01227993|E1|Reported Event|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
188479|NCT01227980|B3|Baseline|Total|Total of all reporting groups
188480|NCT01227980|B2|Baseline|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188481|NCT01227980|B1|Baseline|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188482|NCT01227980|P2|Participant Flow|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188483|NCT01227980|P1|Participant Flow|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188484|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188485|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188486|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188487|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188488|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188489|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188490|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188491|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188492|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188493|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188494|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188495|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188496|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188497|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188498|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188499|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188500|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188501|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188502|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188503|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188504|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188505|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188506|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188507|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188508|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188509|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188510|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188511|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188512|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188513|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188514|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188515|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188516|NCT01227980|E2|Reported Event|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
188517|NCT01227980|E1|Reported Event|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
188518|NCT01227928|B3|Baseline|Total|Total of all reporting groups
188519|NCT01227928|B2|Baseline|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188520|NCT01227928|B1|Baseline|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188521|NCT01227928|P2|Participant Flow|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188522|NCT01227928|P1|Participant Flow|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188523|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188524|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188525|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188526|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188527|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188528|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188529|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188530|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188531|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188532|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188533|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188534|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188730|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD Patients (Overall Study Population)|
188535|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188536|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188537|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188538|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188539|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188540|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188541|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188542|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188543|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188544|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188545|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188546|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188547|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188548|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188549|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188550|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188551|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188552|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188553|NCT01227928|E2|Reported Event|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
188554|NCT01227928|E1|Reported Event|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
188555|NCT01227902|B5|Baseline|Total|Total of all reporting groups
188556|NCT01227902|B4|Baseline|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188557|NCT01227902|B3|Baseline|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188558|NCT01227902|B2|Baseline|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188559|NCT01227902|B1|Baseline|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188560|NCT01227902|P4|Participant Flow|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188561|NCT01227902|P3|Participant Flow|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188562|NCT01227902|P2|Participant Flow|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188563|NCT01227902|P1|Participant Flow|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188564|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188565|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188566|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188567|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188568|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188569|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188570|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188571|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188572|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188573|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188574|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188575|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188576|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188687|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188731|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
188732|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
188733|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
188577|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188578|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188579|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188580|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188581|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188582|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188583|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188584|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188585|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188586|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188587|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188588|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188589|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188590|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188688|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188591|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188592|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188593|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188594|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188595|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188596|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188597|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188598|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188599|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188600|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188601|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188602|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188603|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188604|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188689|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188734|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
188735|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
188736|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
188605|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188606|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188607|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188608|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188609|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188610|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188611|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188612|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188613|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188614|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188615|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188616|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188617|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188632|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188618|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188619|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188620|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188621|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188622|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188623|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188624|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188625|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188626|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188627|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188628|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188629|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188630|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188631|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188683|NCT01227824|B2|Baseline|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188721|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188722|NCT01227785|O2|Outcome|INCEPTA ICD|
188723|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188633|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188634|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188635|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188636|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188637|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188638|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188639|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188640|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188641|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188642|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188643|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188644|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
188645|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188646|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188684|NCT01227824|B1|Baseline|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188724|NCT01227785|O2|Outcome|INCEPTA ICD|
188647|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188648|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188649|NCT01227902|E4|Reported Event|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188650|NCT01227902|E3|Reported Event|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188651|NCT01227902|E2|Reported Event|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188652|NCT01227902|E1|Reported Event|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
188653|NCT01227889|B3|Baseline|Total|Total of all reporting groups
188654|NCT01227889|B2|Baseline|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
188655|NCT01227889|B1|Baseline|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188656|NCT01227889|P2|Participant Flow|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
188657|NCT01227889|P1|Participant Flow|GSK2118436 150 mg BID|Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188685|NCT01227824|P2|Participant Flow|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188658|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188659|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188660|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188661|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188662|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
188663|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
188664|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188665|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188666|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
188667|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188668|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188669|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188686|NCT01227824|P1|Participant Flow|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188725|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188726|NCT01227785|O2|Outcome|INCEPTA ICD|
188670|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188671|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188672|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188673|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188674|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable adverse AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188675|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188676|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188677|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188678|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188679|NCT01227889|E3|Reported Event|GSK25118436 in the Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
188680|NCT01227889|E2|Reported Event|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
188681|NCT01227889|E1|Reported Event|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
188682|NCT01227824|B3|Baseline|Total|Total of all reporting groups
188727|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188728|NCT01227785|O2|Outcome|INCEPTA ICD|
188690|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188691|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188692|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188693|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188694|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188695|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188696|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188697|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188698|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188699|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188700|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188701|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188702|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188703|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188704|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188705|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188706|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188707|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188708|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188709|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188710|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188711|NCT01227824|E2|Reported Event|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
188712|NCT01227824|E1|Reported Event|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
188713|NCT01227785|B1|Baseline|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
188714|NCT01227785|P1|Participant Flow|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
188715|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD (Overall Study Population)|
188716|NCT01227785|O2|Outcome|INCEPTA ICD|
188717|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188718|NCT01227785|O2|Outcome|INCEPTA ICD|
188719|NCT01227785|O1|Outcome|INCEPTA CRT-D|
188720|NCT01227785|O2|Outcome|INCEPTA ICD|
188775|NCT01227785|O2|Outcome|Group 2: Patients Without a HFE|Patients who did not experience a protocol-defined HFE
188776|NCT01227785|O1|Outcome|Group1: Patients With a HFE|Patients who experienced a protocol-defined HF event
188777|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
188778|NCT01227785|E1|Reported Event|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
188779|NCT01227707|B1|Baseline|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188780|NCT01227707|P1|Participant Flow|Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188781|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188782|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188783|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188784|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188785|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188786|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188787|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188810|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188871|NCT01227629|O10|Outcome|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
188788|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188789|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188790|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188791|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188792|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188793|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188794|NCT01227707|E1|Reported Event|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
188795|NCT01227681|B4|Baseline|Total|Total of all reporting groups
188796|NCT01227681|B3|Baseline|Placebo|normal saline 0.9% injection
188797|NCT01227681|B2|Baseline|Low Dose G-CSF Injection for Parkinson's Disease|1.65 ug/kg/day for consecutive 5 days of each 60 day cycle
188798|NCT01227681|B1|Baseline|High Dose G-CSF Injection for Parkinson's Disease|3.3 ug/kg/day for consecutive 5 days of each 60 day cycle
188799|NCT01227681|P3|Participant Flow|Placebo|subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
188800|NCT01227681|P2|Participant Flow|Low Dose G-CSF|1.65ug/kg/day for consecutive 5 days of each 60 day cycle
188801|NCT01227681|P1|Participant Flow|G-CSF|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
188802|NCT01227681|O1|Outcome|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
188803|NCT01227681|E1|Reported Event|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
188804|NCT01227668|B3|Baseline|Total|Total of all reporting groups
188805|NCT01227668|B2|Baseline|Placebo|Phase 2: Participants received placebo for 16 weeks.
188806|NCT01227668|B1|Baseline|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188807|NCT01227668|P2|Participant Flow|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
188808|NCT01227668|P1|Participant Flow|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|"Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.~Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability."
188809|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
188870|NCT01227629|O11|Outcome|D300bid|Dabigatran 300 mg twice daily
188811|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
188812|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo (pb)for 16 weeks.
188813|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole (ARP) at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188814|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
188815|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188816|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
188817|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188818|NCT01227668|E3|Reported Event|Placebo (Phase 2 Only)|Phase 2 only: Participants received placebo for 16 weeks.
188819|NCT01227668|E2|Reported Event|Aripiprazole, 2-15 mg (Phase 2)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
188820|NCT01227668|E1|Reported Event|Aripiprazole, 2-15 mg (Phase 1)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
188821|NCT01227655|B4|Baseline|Total|Total of all reporting groups
188822|NCT01227655|B3|Baseline|Placebo|Placebo: comparator
188823|NCT01227655|B2|Baseline|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188824|NCT01227655|B1|Baseline|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188825|NCT01227655|P3|Participant Flow|Placebo|Placebo: comparator
188826|NCT01227655|P2|Participant Flow|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188827|NCT01227655|P1|Participant Flow|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188828|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
188829|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188830|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188831|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
188832|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188833|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188834|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
188835|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188836|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188837|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
188838|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188839|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188840|NCT01227655|E3|Reported Event|Placebo|Placebo: comparator
188841|NCT01227655|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
188842|NCT01227655|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
188843|NCT01227629|B11|Baseline|Total|Total of all reporting groups
188844|NCT01227629|B10|Baseline|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188845|NCT01227629|B9|Baseline|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188846|NCT01227629|B8|Baseline|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188847|NCT01227629|B7|Baseline|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188848|NCT01227629|B6|Baseline|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188849|NCT01227629|B5|Baseline|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188850|NCT01227629|B4|Baseline|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188851|NCT01227629|B3|Baseline|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188852|NCT01227629|B2|Baseline|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188853|NCT01227629|B1|Baseline|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188854|NCT01227629|P10|Participant Flow|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188855|NCT01227629|P9|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188856|NCT01227629|P8|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188857|NCT01227629|P7|Participant Flow|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188858|NCT01227629|P6|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188859|NCT01227629|P5|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188860|NCT01227629|P4|Participant Flow|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188861|NCT01227629|P3|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188862|NCT01227629|P2|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188863|NCT01227629|P1|Participant Flow|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188864|NCT01227629|O17|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|Warfarin once daily
188865|NCT01227629|O16|Outcome|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
188866|NCT01227629|O15|Outcome|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
188867|NCT01227629|O14|Outcome|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
188868|NCT01227629|O13|Outcome|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
188869|NCT01227629|O12|Outcome|D300qd|Dabigatran 300 mg once daily
188872|NCT01227629|O9|Outcome|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
188873|NCT01227629|O8|Outcome|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
188874|NCT01227629|O7|Outcome|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
188875|NCT01227629|O6|Outcome|D150qd|Dabigatran 150 mg once daily
188876|NCT01227629|O5|Outcome|D150bid|Dabigatran 150 mg twice daily
188877|NCT01227629|O4|Outcome|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
188878|NCT01227629|O3|Outcome|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
188879|NCT01227629|O2|Outcome|D50qd|Dabigatran 50 mg once daily
188880|NCT01227629|O1|Outcome|D50bid|Dabigatran 50 mg twice daily
188881|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188882|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188883|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188884|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188885|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188886|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188887|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188888|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188889|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188890|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188891|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188892|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188893|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188894|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188895|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188896|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188897|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188898|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188899|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188900|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188901|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188902|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188903|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188904|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188905|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188906|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188907|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188908|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188909|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188910|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188911|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188912|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188913|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188914|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188915|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188916|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188917|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188918|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188919|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188920|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188921|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188922|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188923|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188924|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188925|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188926|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188927|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188928|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188929|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188930|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188931|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188932|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188933|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188934|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188935|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188936|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188937|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188938|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188939|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188940|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188941|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188942|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188943|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188944|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188945|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188946|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188947|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188948|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188949|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188950|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188951|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188952|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188953|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188954|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188955|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188956|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188957|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188958|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188959|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188960|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188961|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188962|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188963|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188964|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188965|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188966|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188967|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188968|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188969|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188970|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188971|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188972|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188973|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188974|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188975|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188976|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188977|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188978|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188979|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188980|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188981|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188982|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188983|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188984|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188985|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188986|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188987|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188988|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188989|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
188990|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
188991|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
188992|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188993|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188994|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
188995|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
188996|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
188997|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
188998|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
206752|NCT01174784|P1|Participant Flow|Enrolled/Primary Cohort|
188999|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189000|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189001|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189002|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189003|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189004|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189005|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189006|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189007|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189008|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189009|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189010|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189011|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189012|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189013|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189014|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189015|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189016|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189017|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189018|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189019|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189020|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189021|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189022|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189023|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189024|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189025|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189026|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189027|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189028|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189029|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189030|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189031|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189032|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189033|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189034|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189035|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189036|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189037|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189038|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189039|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189040|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189041|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189042|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189043|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189044|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189045|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189046|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189047|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189048|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189049|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189050|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189051|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189052|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189053|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189054|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189055|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189056|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189057|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189058|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189059|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189060|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189061|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
206753|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
189062|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189063|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189064|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189065|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189066|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189067|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189068|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189069|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189070|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189071|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
189072|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189073|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189074|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
189075|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189076|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
189077|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
189078|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
189079|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
189080|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
189081|NCT01227629|E17|Reported Event|Warfarin|Warfarin once daily
189082|NCT01227629|E16|Reported Event|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
189083|NCT01227629|E15|Reported Event|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
189084|NCT01227629|E14|Reported Event|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
189085|NCT01227629|E13|Reported Event|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
189086|NCT01227629|E12|Reported Event|D300qd|Dabigatran 300 mg once daily
189087|NCT01227629|E11|Reported Event|D300bid|Dabigatran 300 mg twice daily
189088|NCT01227629|E10|Reported Event|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
189089|NCT01227629|E9|Reported Event|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
189090|NCT01227629|E8|Reported Event|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
189091|NCT01227629|E7|Reported Event|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
189092|NCT01227629|E6|Reported Event|D150qd|Dabigatran 150 mg once daily
189093|NCT01227629|E5|Reported Event|D150bid|Dabigatran 150 mg twice daily
189094|NCT01227629|E4|Reported Event|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
189095|NCT01227629|E3|Reported Event|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
189096|NCT01227629|E2|Reported Event|D50qd|Dabigatran 50 mg once daily
189097|NCT01227629|E1|Reported Event|D50bid|Dabigatran 50 mg twice daily
189098|NCT01227577|B1|Baseline|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189099|NCT01227577|P1|Participant Flow|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189100|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189101|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189102|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189103|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189104|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189105|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189106|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189107|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189108|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189109|NCT01227577|E1|Reported Event|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
189110|NCT01227564|B4|Baseline|Total|Total of all reporting groups
189111|NCT01227564|B3|Baseline|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189112|NCT01227564|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189113|NCT01227564|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189114|NCT01227564|P3|Participant Flow|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189305|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189115|NCT01227564|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189116|NCT01227564|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189117|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189118|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189119|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189120|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189121|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189122|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189123|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189124|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189125|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189126|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189127|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189128|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189129|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189130|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189131|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189132|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189133|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189134|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189135|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189136|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189137|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189138|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189139|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189140|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189141|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189142|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189143|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189144|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189145|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189146|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189147|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189148|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189149|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189150|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189151|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189152|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189153|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189154|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189155|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189156|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189157|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189158|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189159|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189160|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189161|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189162|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189163|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189164|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189165|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189166|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189167|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189168|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189169|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189170|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189171|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189172|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189173|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189174|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189175|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189176|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189177|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189178|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189179|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189180|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189181|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189182|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189183|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189184|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189185|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189186|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189187|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189188|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189189|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189190|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189191|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189192|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189193|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189194|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189195|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189196|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189197|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189198|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189199|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189200|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189201|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189202|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189203|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189204|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189205|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189206|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189207|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189306|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189208|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189209|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189210|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189211|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189212|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189213|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189214|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189215|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189216|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189217|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189218|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189219|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189220|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189221|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189222|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189223|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189224|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189225|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189226|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189227|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189228|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189229|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189230|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189231|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189232|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189233|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189234|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189235|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189236|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189237|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189238|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189239|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189240|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189241|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189242|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189243|NCT01227564|E3|Reported Event|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189244|NCT01227564|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189245|NCT01227564|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
189246|NCT01227512|B3|Baseline|Total|Total of all reporting groups
189247|NCT01227512|B2|Baseline|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189248|NCT01227512|B1|Baseline|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189249|NCT01227512|P2|Participant Flow|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189250|NCT01227512|P1|Participant Flow|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189251|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189252|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189253|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189254|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189255|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189256|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189257|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based on serum sodium response.
189258|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189259|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189260|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189261|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189262|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189263|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction be may titrated based on serum sodium response.
189264|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189265|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189266|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189267|NCT01227512|E2|Reported Event|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
189268|NCT01227512|E1|Reported Event|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
189269|NCT01227434|B3|Baseline|Total|Total of all reporting groups
189270|NCT01227434|B2|Baseline|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189307|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189308|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189271|NCT01227434|B1|Baseline|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189272|NCT01227434|P2|Participant Flow|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189273|NCT01227434|P1|Participant Flow|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189274|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189275|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 at a dose of 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189276|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189277|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189278|NCT01227434|E2|Reported Event|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189279|NCT01227434|E1|Reported Event|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
189280|NCT01227421|B4|Baseline|Total|Total of all reporting groups
189281|NCT01227421|B3|Baseline|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189282|NCT01227421|B2|Baseline|Placebo|placebo tablet twice daily with food for 5 days
189283|NCT01227421|B1|Baseline|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189284|NCT01227421|P3|Participant Flow|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189285|NCT01227421|P2|Participant Flow|Placebo|placebo tablet twice daily with food for 5 days
189286|NCT01227421|P1|Participant Flow|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189287|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189288|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189289|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189290|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189291|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189292|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189293|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189294|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189295|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189296|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189297|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189298|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189299|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189300|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189301|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189302|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189303|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189304|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189309|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189310|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189311|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189312|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189313|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189314|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189315|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189316|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189317|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189318|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189319|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189320|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189321|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189322|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189323|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189324|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189325|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189326|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189327|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189328|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189329|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189330|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
189331|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189332|NCT01227421|E3|Reported Event|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
189333|NCT01227421|E2|Reported Event|Placebo|placebo tablet twice daily with food for 5 days
189334|NCT01227421|E1|Reported Event|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
189335|NCT01227395|B3|Baseline|Total|Total of all reporting groups
189336|NCT01227395|B2|Baseline|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189337|NCT01227395|B1|Baseline|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189338|NCT01227395|P2|Participant Flow|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189339|NCT01227395|P1|Participant Flow|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189340|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189341|NCT01227395|O1|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189342|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
189343|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
189344|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
189345|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
189346|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189347|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189348|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
189349|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
189350|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189351|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189352|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189353|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189354|NCT01227395|O2|Outcome|Azithromycin Without Concomitant Drugs|Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189355|NCT01227395|O1|Outcome|Azithromycin With Concomitant Drugs|Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189356|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189357|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189358|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189359|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189360|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189361|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189362|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189363|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189364|NCT01227395|E2|Reported Event|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
189365|NCT01227395|E1|Reported Event|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
189366|NCT01227382|B1|Baseline|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189367|NCT01227382|P1|Participant Flow|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189368|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189369|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189370|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189371|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189372|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189373|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189374|NCT01227382|O1|Outcome|Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189375|NCT01227382|E1|Reported Event|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
189376|NCT01227278|B3|Baseline|Total|Total of all reporting groups
189377|NCT01227278|B2|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189378|NCT01227278|B1|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189379|NCT01227278|P2|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189380|NCT01227278|P1|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189381|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189382|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189383|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189384|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189385|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189386|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189387|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189388|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189389|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189390|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189391|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189392|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189393|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189394|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189395|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189396|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189397|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189398|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189399|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189400|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189401|NCT01227278|E2|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189402|NCT01227278|E1|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
189403|NCT01227265|B4|Baseline|Total|Total of all reporting groups
189404|NCT01227265|B3|Baseline|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189405|NCT01227265|B2|Baseline|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189406|NCT01227265|B1|Baseline|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189407|NCT01227265|P3|Participant Flow|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189408|NCT01227265|P2|Participant Flow|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189409|NCT01227265|P1|Participant Flow|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189410|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189411|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189412|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189413|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189414|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189415|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189416|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189417|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189418|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189419|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189420|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189421|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189422|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189423|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189424|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189425|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189426|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189427|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189428|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189429|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189430|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189431|NCT01227265|E3|Reported Event|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
189432|NCT01227265|E2|Reported Event|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189433|NCT01227265|E1|Reported Event|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
189434|NCT01227057|B3|Baseline|Total|Total of all reporting groups
189435|NCT01227057|B2|Baseline|Arm 2: Case Management|Case Management: Case management
189436|NCT01227057|B1|Baseline|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
189437|NCT01227057|P2|Participant Flow|Arm 2: Case Management|Case Management: Case management
189438|NCT01227057|P1|Participant Flow|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
189439|NCT01227057|O2|Outcome|Arm 2: Case Management|"Case management~Case Management: Case management"
189440|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
189441|NCT01227057|O2|Outcome|Arm 2: Case Management|Case Management: Case management
189442|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
189443|NCT01227057|E2|Reported Event|Arm 2: Case Management|Case Management: Case management
189444|NCT01227057|E1|Reported Event|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
189445|NCT01227018|B1|Baseline|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189446|NCT01227018|P1|Participant Flow|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189447|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189448|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189449|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189450|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189451|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
189452|NCT01227018|E1|Reported Event|STA-9090|175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
189453|NCT01227005|B3|Baseline|Total|Total of all reporting groups
189454|NCT01227005|B2|Baseline|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189713|NCT01226043|O2|Outcome|Vial and Syringe|Vial and Syringe used during the crossover phase either at period 1 or at period 2
189455|NCT01227005|B1|Baseline|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189456|NCT01227005|P2|Participant Flow|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189457|NCT01227005|P1|Participant Flow|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189458|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189459|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189460|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189461|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189462|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189463|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189464|NCT01227005|E2|Reported Event|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189465|NCT01227005|E1|Reported Event|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
189466|NCT01226745|B7|Baseline|Total|Total of all reporting groups
189467|NCT01226745|B6|Baseline|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189468|NCT01226745|B5|Baseline|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189469|NCT01226745|B4|Baseline|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189470|NCT01226745|B3|Baseline|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189471|NCT01226745|B2|Baseline|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189472|NCT01226745|B1|Baseline|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189473|NCT01226745|P6|Participant Flow|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189474|NCT01226745|P5|Participant Flow|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189475|NCT01226745|P4|Participant Flow|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189476|NCT01226745|P3|Participant Flow|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189477|NCT01226745|P2|Participant Flow|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189478|NCT01226745|P1|Participant Flow|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189479|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189480|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189481|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189482|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189483|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189484|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189485|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189486|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189487|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189488|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189489|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189490|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189491|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189492|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189493|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189494|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189495|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189496|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189497|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189498|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189499|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189500|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189501|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189502|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189503|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189504|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189505|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189506|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189507|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189508|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189509|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189510|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189511|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189512|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189513|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189514|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189515|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189516|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189517|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189518|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189519|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189520|NCT01226745|O1|Outcome|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189521|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189522|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189523|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189524|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189525|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189526|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189527|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189528|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189529|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189530|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189531|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189532|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189533|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189534|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189535|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189536|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189537|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189538|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189539|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189540|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189541|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189542|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189543|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189544|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189545|NCT01226745|E6|Reported Event|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189546|NCT01226745|E5|Reported Event|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189547|NCT01226745|E4|Reported Event|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189548|NCT01226745|E3|Reported Event|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
189549|NCT01226745|E2|Reported Event|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
189550|NCT01226745|E1|Reported Event|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
189551|NCT01226732|B7|Baseline|Total|Total of all reporting groups
189552|NCT01226732|B6|Baseline|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189553|NCT01226732|B5|Baseline|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189554|NCT01226732|B4|Baseline|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189555|NCT01226732|B3|Baseline|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189556|NCT01226732|B2|Baseline|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189557|NCT01226732|B1|Baseline|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189558|NCT01226732|P6|Participant Flow|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189559|NCT01226732|P5|Participant Flow|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189560|NCT01226732|P4|Participant Flow|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189561|NCT01226732|P3|Participant Flow|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189562|NCT01226732|P2|Participant Flow|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189563|NCT01226732|P1|Participant Flow|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189564|NCT01226732|O1|Outcome|All Patients|The Response Rate is determined for all patients
189565|NCT01226732|O6|Outcome|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189714|NCT01226043|O1|Outcome|SoloSTAR® Pen|SoloSTAR® Pen used during the crossover phase either at period 1 or at period 2
189566|NCT01226732|O5|Outcome|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189567|NCT01226732|O4|Outcome|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189568|NCT01226732|O3|Outcome|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189569|NCT01226732|O2|Outcome|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189570|NCT01226732|O1|Outcome|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189571|NCT01226732|O1|Outcome|All Patients|The Maximum Tolerated Dose (MTD) is determined for all patients
189572|NCT01226732|E6|Reported Event|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189573|NCT01226732|E5|Reported Event|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189574|NCT01226732|E4|Reported Event|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189575|NCT01226732|E3|Reported Event|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189576|NCT01226732|E2|Reported Event|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189577|NCT01226732|E1|Reported Event|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
189578|NCT01226719|B1|Baseline|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189579|NCT01226719|P1|Participant Flow|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189580|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189581|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189582|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189583|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189602|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189584|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189585|NCT01226719|E1|Reported Event|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
189586|NCT01226511|B3|Baseline|Total|Total of all reporting groups
189587|NCT01226511|B2|Baseline|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
189588|NCT01226511|B1|Baseline|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
189589|NCT01226511|P2|Participant Flow|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
189590|NCT01226511|P1|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
189591|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189592|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189593|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189594|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189595|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189596|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189597|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189598|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189599|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189600|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189601|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
189603|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189604|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189605|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189606|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189607|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189608|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189609|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189610|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189611|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189612|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189613|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189614|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189615|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189616|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189617|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
189618|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
189619|NCT01226511|E6|Reported Event|Placebo-Taper|AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
189620|NCT01226511|E5|Reported Event|Duloxetine-Taper|AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
189621|NCT01226511|E4|Reported Event|Placebo/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
189622|NCT01226511|E3|Reported Event|Duloxetine/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
189623|NCT01226511|E2|Reported Event|Placebo|AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
189624|NCT01226511|E1|Reported Event|Duloxetine|Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
189625|NCT01226459|B3|Baseline|Total|Total of all reporting groups
189626|NCT01226459|B2|Baseline|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189627|NCT01226459|B1|Baseline|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189628|NCT01226459|P2|Participant Flow|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189629|NCT01226459|P1|Participant Flow|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189630|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189631|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189632|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189633|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189634|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189635|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189712|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
206754|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
189636|NCT01226459|E2|Reported Event|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189637|NCT01226459|E1|Reported Event|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
189638|NCT01226420|B1|Baseline|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
189639|NCT01226420|P1|Participant Flow|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
189640|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
189641|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
189642|NCT01226420|E1|Reported Event|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
189643|NCT01226121|B4|Baseline|Total|Total of all reporting groups
189644|NCT01226121|B3|Baseline|Day 4 Manipulation|Finger manipulation four days following collagenase injection
189645|NCT01226121|B2|Baseline|Day 2 Manipulation|Finger manipulation two days following collagenase injection
189646|NCT01226121|B1|Baseline|Day 1 Manipulation|Finger manipulation one day following collagenase injection
189647|NCT01226121|P3|Participant Flow|Day 4 Manipulation|Finger manipulation four days following collagenase injection
189648|NCT01226121|P2|Participant Flow|Day 2 Manipulation|Finger manipulation two days following collagenase injection
189649|NCT01226121|P1|Participant Flow|Day 1 Manipulation|Finger manipulation one day following collagenase injection
189650|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
189651|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
189652|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
189653|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
189654|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
189655|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
189656|NCT01226121|E3|Reported Event|Day 4 Manipulation|Finger manipulation four days following collagenase injection
189657|NCT01226121|E2|Reported Event|Day 2 Manipulation|Finger manipulation two days following collagenase injection
189658|NCT01226121|E1|Reported Event|Day 1 Manipulation|Finger manipulation one day following collagenase injection
189659|NCT01226095|B1|Baseline|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189660|NCT01226095|P1|Participant Flow|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189661|NCT01226095|O1|Outcome|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189662|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189663|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189664|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
189665|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189666|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189667|NCT01226095|O1|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189668|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189669|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189670|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
189671|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189672|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189673|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189674|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189675|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
189676|NCT01226095|O3|Outcome|Brufen Retard (All Visits)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.
189677|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189678|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
189679|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189680|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
189681|NCT01226095|E1|Reported Event|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
189682|NCT01226043|B3|Baseline|Total|Total of all reporting groups
189683|NCT01226043|B2|Baseline|Crossover Phase: Vial & Syringe / Pen|Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.
189684|NCT01226043|B1|Baseline|Crossover Phase: Pen / Vial & Syringe|Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.
189685|NCT01226043|P4|Participant Flow|Vial and Syringe|Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
189686|NCT01226043|P3|Participant Flow|SoloSTAR® Pen|Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.
189687|NCT01226043|P2|Participant Flow|Vial &Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.
189688|NCT01226043|P1|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.
189689|NCT01226043|O6|Outcome|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
189690|NCT01226043|O5|Outcome|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
189691|NCT01226043|O4|Outcome|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
189692|NCT01226043|O3|Outcome|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
189693|NCT01226043|O2|Outcome|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189694|NCT01226043|O1|Outcome|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189695|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the observational phase.
189696|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the observational phase.
189697|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the re-randomization phase.
189698|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the re-randomization phase.
189699|NCT01226043|O4|Outcome|Vial and Syringe (Period 1)|Patients using Vial and Syringe during period 1 of the crossover phase.
189700|NCT01226043|O3|Outcome|SoloSTAR® Pen (Period 2)|Patients using SoloSTAR® pen during period 2 of the crossover phase.
189701|NCT01226043|O2|Outcome|Vial and Syringe (Period 2)|Patients using Vial and Syringe during period 2 of the crossover phase.
189702|NCT01226043|O1|Outcome|SoloSTAR® Pen (Period 1)|Patients using SoloSTAR® pen during period 1 of the crossover phase.
189703|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
189704|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
189705|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
189706|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
189707|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
189708|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
189709|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
189710|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
189711|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
206755|NCT01174784|E1|Reported Event|Enrolled/Primary Cohort|
189715|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189716|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189717|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189718|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189719|NCT01226043|E6|Reported Event|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
189720|NCT01226043|E5|Reported Event|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
189721|NCT01226043|E4|Reported Event|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
189722|NCT01226043|E3|Reported Event|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
189723|NCT01226043|E2|Reported Event|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189724|NCT01226043|E1|Reported Event|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
189725|NCT01225991|B1|Baseline|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
189726|NCT01225991|P1|Participant Flow|Milnacipran, Active Drug, Open-label|"All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.~Milnacipran: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day"
189727|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
189728|NCT01225991|E1|Reported Event|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
189729|NCT01225952|B4|Baseline|Total|Total of all reporting groups
189730|NCT01225952|B3|Baseline|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189731|NCT01225952|B2|Baseline|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189732|NCT01225952|B1|Baseline|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189733|NCT01225952|P3|Participant Flow|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189734|NCT01225952|P2|Participant Flow|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189735|NCT01225952|P1|Participant Flow|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189736|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189737|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189738|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189739|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
206756|NCT01174576|B1|Baseline|Group 1|
189740|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189741|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189742|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189743|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189744|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189745|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189746|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189747|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189748|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189749|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189750|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189751|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189752|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189753|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189754|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189755|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189756|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189757|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189758|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189759|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189760|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189761|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189762|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189763|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189764|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189765|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189766|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189767|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189768|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189769|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189770|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189771|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189772|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189773|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189774|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189775|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189776|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189777|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189778|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189779|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189780|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189781|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189782|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189783|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189784|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189785|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189786|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189787|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189788|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189789|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189790|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189791|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189792|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189793|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189794|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189795|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189796|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189797|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189798|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189799|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189800|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189801|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189802|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189803|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189804|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189805|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189806|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189807|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189808|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189809|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189810|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189811|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189812|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189813|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189814|NCT01225952|E3|Reported Event|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
189815|NCT01225952|E2|Reported Event|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
189816|NCT01225952|E1|Reported Event|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
189817|NCT01225926|B3|Baseline|Total|Total of all reporting groups
189818|NCT01225926|B2|Baseline|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189819|NCT01225926|B1|Baseline|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189820|NCT01225926|P2|Participant Flow|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189821|NCT01225926|P1|Participant Flow|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189822|NCT01225926|O2|Outcome|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189823|NCT01225926|O1|Outcome|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189913|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40mg qd (once daily) subcutaneous injection
189824|NCT01225926|E2|Reported Event|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189825|NCT01225926|E1|Reported Event|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
189826|NCT01225835|B3|Baseline|Total|Total of all reporting groups
189827|NCT01225835|B2|Baseline|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189828|NCT01225835|B1|Baseline|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189829|NCT01225835|P2|Participant Flow|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189830|NCT01225835|P1|Participant Flow|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189831|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189832|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189833|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189834|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189835|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189836|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189837|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189838|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189839|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189840|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189841|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189842|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189843|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189844|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189845|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189846|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189847|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189848|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189849|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189850|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189851|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189852|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189853|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189854|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189855|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189856|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189857|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189858|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189859|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189860|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189861|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189914|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189915|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189862|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189863|NCT01225835|O1|Outcome|All Participants|The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants.
189864|NCT01225835|O6|Outcome|Follitrophin Alpha: Stratum Age >=39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old.
189865|NCT01225835|O5|Outcome|Follitrophin Alpha: Stratum Age <39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were < 39 years old.
189866|NCT01225835|O4|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189867|NCT01225835|O3|Outcome|Menotrophin: Stratum Age >=39 Yrs|The subset of participants in the menotrophin treatment arm who were >= 39 years old.
189868|NCT01225835|O2|Outcome|Menotrophin: Stratum Age <39 Yrs|The subset of participants in the menotrophin treatment arm who were < 39 years old.
189869|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189870|NCT01225835|E2|Reported Event|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189871|NCT01225835|E1|Reported Event|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
189872|NCT01225822|B6|Baseline|Total|Total of all reporting groups
189873|NCT01225822|B5|Baseline|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189874|NCT01225822|B4|Baseline|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189875|NCT01225822|B3|Baseline|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189876|NCT01225822|B2|Baseline|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189877|NCT01225822|B1|Baseline|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189878|NCT01225822|P5|Participant Flow|Enoxaparin 40 mg qd|Enoxaparin 40 qd (once daily) subcutaneous injection
189879|NCT01225822|P4|Participant Flow|BIBR 1048 300 mg qd|Dabigatran 300 mg qd(once daily) oral
189880|NCT01225822|P3|Participant Flow|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid(twice daily) oral
189881|NCT01225822|P2|Participant Flow|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid(twice daily) oral
189882|NCT01225822|P1|Participant Flow|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid(twice daily) oral
189883|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189884|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189885|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189886|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189887|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189888|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189889|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189890|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189891|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189892|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189893|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189894|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189895|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189896|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189897|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189898|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189899|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189900|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189901|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189902|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189903|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189904|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189905|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189906|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189907|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189908|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189909|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189910|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189911|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189912|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189916|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189917|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189918|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mgqd (once daily) subcutaneous injection
189919|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189920|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189921|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189922|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189923|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189924|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189925|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189926|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189927|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189928|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189929|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189930|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189931|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189932|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189933|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189934|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189935|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189936|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189937|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189938|NCT01225822|E5|Reported Event|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
189939|NCT01225822|E4|Reported Event|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
189940|NCT01225822|E3|Reported Event|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
189941|NCT01225822|E2|Reported Event|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
189942|NCT01225822|E1|Reported Event|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
189943|NCT01225731|B6|Baseline|Total|Total of all reporting groups
189944|NCT01225731|B5|Baseline|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189945|NCT01225731|B4|Baseline|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189946|NCT01225731|B3|Baseline|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189947|NCT01225731|B2|Baseline|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189948|NCT01225731|B1|Baseline|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189949|NCT01225731|P13|Participant Flow|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
189950|NCT01225731|P12|Participant Flow|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
189951|NCT01225731|P11|Participant Flow|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
189952|NCT01225731|P10|Participant Flow|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
189953|NCT01225731|P9|Participant Flow|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
189954|NCT01225731|P8|Participant Flow|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
189955|NCT01225731|P7|Participant Flow|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
189956|NCT01225731|P6|Participant Flow|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
189957|NCT01225731|P5|Participant Flow|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189958|NCT01225731|P4|Participant Flow|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189959|NCT01225731|P3|Participant Flow|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189960|NCT01225731|P2|Participant Flow|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189961|NCT01225731|P1|Participant Flow|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189962|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
189963|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
189964|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
189965|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
189966|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189967|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189968|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189969|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189970|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189971|NCT01225731|O13|Outcome|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
190026|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189972|NCT01225731|O12|Outcome|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
189973|NCT01225731|O11|Outcome|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
189974|NCT01225731|O10|Outcome|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
189975|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
189976|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
189977|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
189978|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
189979|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189980|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189981|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189982|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189983|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189984|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189985|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189986|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189987|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189988|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189989|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189990|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189991|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189992|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189993|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189994|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
189995|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
189996|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
189997|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
189998|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
189999|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190000|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190001|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190002|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190003|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190004|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190005|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190006|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190007|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190008|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190009|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190010|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190011|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190012|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190013|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190014|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190015|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190016|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190017|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190018|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190019|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190020|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190021|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190022|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190023|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190024|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190025|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190027|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190028|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190029|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190030|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190031|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190032|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190033|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190034|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190035|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190036|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190037|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190038|NCT01225731|E14|Reported Event|Placebo Follow-up|Participants who received placebo in Part 1 and did not receive additional therapy.
190039|NCT01225731|E13|Reported Event|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
190040|NCT01225731|E12|Reported Event|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
190041|NCT01225731|E11|Reported Event|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
190042|NCT01225731|E10|Reported Event|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
190043|NCT01225731|E9|Reported Event|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
190044|NCT01225731|E8|Reported Event|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
190045|NCT01225731|E7|Reported Event|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
190046|NCT01225731|E6|Reported Event|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
190047|NCT01225731|E5|Reported Event|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
190048|NCT01225731|E4|Reported Event|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
190049|NCT01225731|E3|Reported Event|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
190050|NCT01225731|E2|Reported Event|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
190051|NCT01225731|E1|Reported Event|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
190052|NCT01225562|B4|Baseline|Total|Total of all reporting groups
190053|NCT01225562|B3|Baseline|Placebo|Matching placebo
190054|NCT01225562|B2|Baseline|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190055|NCT01225562|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190056|NCT01225562|P3|Participant Flow|Placebo|Matching placebo
190057|NCT01225562|P2|Participant Flow|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190058|NCT01225562|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190059|NCT01225562|O3|Outcome|Placebo|Matching placebo
190060|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190061|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190062|NCT01225562|O3|Outcome|Placebo|Matching placebo
190063|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190064|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190065|NCT01225562|O3|Outcome|Placebo|Matching placebo
190066|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190067|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190068|NCT01225562|O3|Outcome|Placebo|Matching placebo
190069|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
190070|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
190071|NCT01225562|E3|Reported Event|Ticagrelor 90mg bd|
190072|NCT01225562|E2|Reported Event|Ticagrelor 60mg bd|
190073|NCT01225562|E1|Reported Event|Placebo|
190074|NCT01225549|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study
190075|NCT01225549|P10|Participant Flow|PCBA|Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
190076|NCT01225549|P9|Participant Flow|PCAB|Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
190077|NCT01225549|P8|Participant Flow|PBAC|Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
190078|NCT01225549|P7|Participant Flow|CBPA|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
190079|NCT01225549|P6|Participant Flow|CBAP|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
190080|NCT01225549|P5|Participant Flow|CAPB|Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
190081|NCT01225549|P4|Participant Flow|BPCA|AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
190082|NCT01225549|P3|Participant Flow|BACP|AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
190083|NCT01225549|P2|Participant Flow|APBC|AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
190084|NCT01225549|P1|Participant Flow|ACBP|AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
190814|NCT01222104|O1|Outcome|All Participants With Deployments and Readable Angiograms|
190085|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190086|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190087|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190088|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190089|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190090|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190091|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190092|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190093|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190094|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190095|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190096|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190097|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190098|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190099|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190100|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190101|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190102|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190103|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190104|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190105|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190106|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190107|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190108|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190109|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190110|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190111|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190112|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190113|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190114|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190115|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190116|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190117|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190118|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190119|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190120|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190121|NCT01225549|E4|Reported Event|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
190122|NCT01225549|E3|Reported Event|Arm 3 - 2x200ug Budesonide|2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
190123|NCT01225549|E2|Reported Event|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190124|NCT01225549|E1|Reported Event|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
190125|NCT01225354|B1|Baseline|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
190126|NCT01225354|P1|Participant Flow|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
190127|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
190128|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
190129|NCT01225354|E1|Reported Event|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
190130|NCT01225289|B3|Baseline|Total|Total of all reporting groups
190131|NCT01225289|B2|Baseline|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190132|NCT01225289|B1|Baseline|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190133|NCT01225289|P2|Participant Flow|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190134|NCT01225289|P1|Participant Flow|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190135|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190136|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190137|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190138|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190139|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190140|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190141|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190142|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190143|NCT01225289|E2|Reported Event|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
190144|NCT01225289|E1|Reported Event|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
190145|NCT01225263|B3|Baseline|Total|Total of all reporting groups
190146|NCT01225263|B2|Baseline|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
190147|NCT01225263|B1|Baseline|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
190148|NCT01225263|P2|Participant Flow|"Placebo Sugar Pill"|Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
190149|NCT01225263|P1|Participant Flow|Simvastatin and Vitamin D|Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
190150|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
190151|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
190152|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
190153|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
190154|NCT01225263|E2|Reported Event|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
190155|NCT01225263|E1|Reported Event|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
190156|NCT01225211|B11|Baseline|Total|Total of all reporting groups
190157|NCT01225211|B10|Baseline|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190158|NCT01225211|B9|Baseline|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190159|NCT01225211|B8|Baseline|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190160|NCT01225211|B7|Baseline|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190161|NCT01225211|B6|Baseline|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190162|NCT01225211|B5|Baseline|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190163|NCT01225211|B4|Baseline|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190164|NCT01225211|B3|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190362|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
190165|NCT01225211|B2|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190166|NCT01225211|B1|Baseline|Cohort 1: Placebo|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190167|NCT01225211|P10|Participant Flow|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190168|NCT01225211|P9|Participant Flow|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190169|NCT01225211|P8|Participant Flow|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190170|NCT01225211|P7|Participant Flow|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190171|NCT01225211|P6|Participant Flow|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190172|NCT01225211|P5|Participant Flow|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190173|NCT01225211|P4|Participant Flow|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190174|NCT01225211|P3|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190175|NCT01225211|P2|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
190176|NCT01225211|P1|Participant Flow|Cohort 1: Placebo|Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
190177|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190178|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190179|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190180|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190181|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190182|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190183|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190184|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190185|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190186|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190187|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190188|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190189|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190190|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190191|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190192|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190193|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190194|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190195|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190196|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190197|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190198|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190199|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190200|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190201|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190202|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190203|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190204|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190205|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190206|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190207|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190208|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190209|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190210|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190211|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190212|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190213|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190214|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190215|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190216|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190217|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190363|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
190218|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190219|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190220|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190221|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190222|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190223|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
190224|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
190225|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd (HE) – Period 1|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
190226|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd (HO) – Period 1|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
190227|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
190228|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
190229|NCT01225211|O2|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
190230|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
190231|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190232|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190233|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190234|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190235|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190236|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190237|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190238|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190239|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190240|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190241|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190242|NCT01225211|O2|Outcome|Cohort 4: Active Study Drug|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190243|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190244|NCT01225211|O10|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190245|NCT01225211|O9|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190246|NCT01225211|O8|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190247|NCT01225211|O7|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190248|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190249|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
190250|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
190251|NCT01225211|O3|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
190252|NCT01225211|O2|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
190253|NCT01225211|O1|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
190254|NCT01225211|O5|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190255|NCT01225211|O4|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190256|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190257|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
190258|NCT01225211|O1|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
190259|NCT01225211|E17|Reported Event|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
190260|NCT01225211|E16|Reported Event|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
190261|NCT01225211|E15|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
190262|NCT01225211|E14|Reported Event|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190263|NCT01225211|E13|Reported Event|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190264|NCT01225211|E12|Reported Event|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190265|NCT01225211|E11|Reported Event|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
190266|NCT01225211|E10|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
190267|NCT01225211|E9|Reported Event|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
190268|NCT01225211|E8|Reported Event|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
190269|NCT01225211|E7|Reported Event|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
190270|NCT01225211|E6|Reported Event|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
190271|NCT01225211|E5|Reported Event|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
190272|NCT01225211|E4|Reported Event|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
190273|NCT01225211|E3|Reported Event|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
190274|NCT01225211|E2|Reported Event|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
190275|NCT01225211|E1|Reported Event|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
190276|NCT01225159|B3|Baseline|Total|Total of all reporting groups
190277|NCT01225159|B2|Baseline|Conventional Glycaemic Control (Control)|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
190278|NCT01225159|B1|Baseline|Tight Glycaemic Control (TGC)|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
190279|NCT01225159|P2|Participant Flow|Conventional Glycaemic Control (Control)|"Allocated to control group (n = 100)~• Received allocated intervention (n = 100)"
190280|NCT01225159|P1|Participant Flow|Tight Glycaemic Control (TGC)|"Allocated to intensive group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
190281|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
190282|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
190283|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
190284|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
190285|NCT01225159|E2|Reported Event|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
190286|NCT01225159|E1|Reported Event|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
190287|NCT01225068|B3|Baseline|Total|Total of all reporting groups
190288|NCT01225068|B2|Baseline|Placebo|Placebo treatment group
190289|NCT01225068|B1|Baseline|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
190290|NCT01225068|P2|Participant Flow|Placebo|Placebo treatment group
190291|NCT01225068|P1|Participant Flow|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
190292|NCT01225068|O2|Outcome|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
190293|NCT01225068|O1|Outcome|Placebo|Placebo arm
190294|NCT01225068|E2|Reported Event|Placebo|Placebo treatment group
190295|NCT01225068|E1|Reported Event|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
190296|NCT01225029|B3|Baseline|Total|Total of all reporting groups
190297|NCT01225029|B2|Baseline|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190298|NCT01225029|B1|Baseline|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190299|NCT01225029|P2|Participant Flow|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190300|NCT01225029|P1|Participant Flow|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190301|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190302|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190303|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190304|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190305|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190306|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190307|NCT01225029|E2|Reported Event|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
190308|NCT01225029|E1|Reported Event|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
190309|NCT01224821|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190310|NCT01224821|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190351|NCT01224431|P1|Participant Flow|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
190311|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190312|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190313|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190314|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190315|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190316|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190317|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190352|NCT01224431|O2|Outcome|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
190353|NCT01224431|O1|Outcome|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
190354|NCT01224431|E2|Reported Event|Placebo Comparator: Normal Saline Via Needleless Injection|
190355|NCT01224431|E1|Reported Event|Experimental: Needleless Injection of Buffered Lidocaine|
190356|NCT01224236|B3|Baseline|Total|Total of all reporting groups
190318|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190319|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190320|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190321|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190322|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190323|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190324|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190357|NCT01224236|B2|Baseline|Control|multivitamin solution without iron
190358|NCT01224236|B1|Baseline|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
190359|NCT01224236|P2|Participant Flow|Control|multivitamin solution without iron
190360|NCT01224236|P1|Participant Flow|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
190361|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
190614|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190325|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190326|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190327|NCT01224821|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
190328|NCT01224782|B1|Baseline|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190329|NCT01224782|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190330|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190331|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190332|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190333|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190334|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190335|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190336|NCT01224782|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
190337|NCT01224626|B1|Baseline|Linezolid|Participants who have been treated with Zyvox (linezolid).
190338|NCT01224626|P1|Participant Flow|Linezolid|Participants who have been treated with Zyvox (linezolid).
190339|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
190340|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
190341|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
190342|NCT01224626|E1|Reported Event|Linezolid|Participants who have been treated with Zyvox (linezolid).
190343|NCT01224444|B1|Baseline|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
190344|NCT01224444|P1|Participant Flow|All Adenomatous Polyps|Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
190345|NCT01224444|O1|Outcome|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
190346|NCT01224444|E1|Reported Event|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
190347|NCT01224431|B3|Baseline|Total|Total of all reporting groups
190348|NCT01224431|B2|Baseline|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
190349|NCT01224431|B1|Baseline|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
190350|NCT01224431|P2|Participant Flow|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
190815|NCT01222104|O1|Outcome|All Participants|All enrolled participants
190364|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
190365|NCT01224236|E2|Reported Event|Control|multivitamin solution without iron
190366|NCT01224236|E1|Reported Event|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
190367|NCT01224171|B3|Baseline|Total|Total of all reporting groups
190368|NCT01224171|B2|Baseline|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190369|NCT01224171|B1|Baseline|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190370|NCT01224171|P2|Participant Flow|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190371|NCT01224171|P1|Participant Flow|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190372|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190373|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190374|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190375|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190376|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190377|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190378|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190379|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190380|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190381|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190382|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190383|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190384|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190385|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190386|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190387|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190388|NCT01224171|E2|Reported Event|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
190389|NCT01224171|E1|Reported Event|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
190390|NCT01224015|B4|Baseline|Total|Total of all reporting groups
190391|NCT01224015|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190392|NCT01224015|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190393|NCT01224015|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190394|NCT01224015|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190395|NCT01224015|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190396|NCT01224015|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190397|NCT01224015|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190398|NCT01224015|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190399|NCT01224015|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190400|NCT01224015|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190401|NCT01224015|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190402|NCT01224015|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
190403|NCT01223937|B3|Baseline|Total|Total of all reporting groups
190404|NCT01223937|B2|Baseline|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190405|NCT01223937|B1|Baseline|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190406|NCT01223937|P2|Participant Flow|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190816|NCT01222104|O1|Outcome|All Participants|
190407|NCT01223937|P1|Participant Flow|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190408|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190409|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190410|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190411|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190412|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190413|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190414|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190415|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190416|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190417|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190418|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190419|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190420|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190421|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190422|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190423|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190424|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190425|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190426|NCT01223937|E2|Reported Event|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190427|NCT01223937|E1|Reported Event|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
190428|NCT01223703|B3|Baseline|Total|Total of all reporting groups
190429|NCT01223703|B2|Baseline|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190430|NCT01223703|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190431|NCT01223703|P2|Participant Flow|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190432|NCT01223703|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190433|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190434|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190435|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190436|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190437|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190438|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
206916|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
190439|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190440|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190441|NCT01223703|E2|Reported Event|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
190442|NCT01223703|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
190443|NCT01223469|B3|Baseline|Total|Total of all reporting groups
190444|NCT01223469|B2|Baseline|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
190445|NCT01223469|B1|Baseline|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
190446|NCT01223469|P2|Participant Flow|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
190447|NCT01223469|P1|Participant Flow|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
190448|NCT01223469|O2|Outcome|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
190449|NCT01223469|O1|Outcome|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
190450|NCT01223469|E2|Reported Event|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
190451|NCT01223469|E1|Reported Event|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
190452|NCT01223196|B3|Baseline|Total|Total of all reporting groups
190453|NCT01223196|B2|Baseline|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
190454|NCT01223196|B1|Baseline|Placebo|One arm of the study subjects will be treated with Placebo only.
190455|NCT01223196|P2|Participant Flow|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
190456|NCT01223196|P1|Participant Flow|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
190457|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
190458|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
190459|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
190460|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
190461|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
190462|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
190463|NCT01223196|E2|Reported Event|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
190464|NCT01223196|E1|Reported Event|Placebo|One arm of the study subjects will be treated with Placebo only.
190465|NCT01223027|B3|Baseline|Total|Total of all reporting groups
190466|NCT01223027|B2|Baseline|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190467|NCT01223027|B1|Baseline|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190468|NCT01223027|P2|Participant Flow|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190469|NCT01223027|P1|Participant Flow|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190470|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190471|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190472|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190473|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190474|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190475|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190476|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190477|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190478|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190479|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190480|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190481|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190482|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190483|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190484|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190485|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190486|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190487|NCT01223027|E2|Reported Event|Sorafenib|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
190488|NCT01223027|E1|Reported Event|Dovitinib|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
190489|NCT01223001|B3|Baseline|Total|Total of all reporting groups
190490|NCT01223001|B2|Baseline|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190491|NCT01223001|B1|Baseline|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190492|NCT01223001|P2|Participant Flow|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190493|NCT01223001|P1|Participant Flow|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190494|NCT01223001|O2|Outcome|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190495|NCT01223001|O1|Outcome|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190496|NCT01223001|E2|Reported Event|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190497|NCT01223001|E1|Reported Event|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
190498|NCT01222884|B3|Baseline|Total|Total of all reporting groups
190499|NCT01222884|B2|Baseline|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
190500|NCT01222884|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
190501|NCT01222884|P2|Participant Flow|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
190502|NCT01222884|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
190503|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
190504|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
190505|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
190506|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
190507|NCT01222884|E2|Reported Event|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
190508|NCT01222884|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
190509|NCT01222689|B1|Baseline|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190510|NCT01222689|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
192070|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
190511|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190512|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190513|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190514|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190515|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190516|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190517|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190518|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190519|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190520|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190521|NCT01222689|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
190522|NCT01222585|B1|Baseline|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190523|NCT01222585|P1|Participant Flow|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190524|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190525|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190526|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190527|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190528|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190529|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190530|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190531|NCT01222585|E1|Reported Event|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
190532|NCT01222572|B1|Baseline|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
190533|NCT01222572|P3|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 3)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
192071|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
190534|NCT01222572|P2|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 2)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
190535|NCT01222572|P1|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
190536|NCT01222572|O1|Outcome|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
190537|NCT01222572|E1|Reported Event|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
190538|NCT01222533|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
190539|NCT01222533|P1|Participant Flow|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.
190540|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190541|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190542|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190543|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190544|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190545|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190546|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190547|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190548|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190549|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190550|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190551|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190552|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190553|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190554|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190555|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190556|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190557|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190558|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190559|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190560|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190561|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
206917|NCT01174446|O5|Outcome|On-Demand: End of Study|
190562|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190563|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190564|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190565|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190566|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190567|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190568|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190569|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190570|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190571|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190572|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190573|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190574|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190575|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190576|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190577|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190578|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190579|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190580|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190581|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190582|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190583|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190584|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190585|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190586|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190587|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190588|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190589|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190590|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190591|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190592|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190593|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190594|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190595|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190596|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190597|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190598|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190599|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190600|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190601|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190602|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190603|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190604|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190605|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190606|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190607|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190608|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190609|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190610|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190611|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190612|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190613|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
216764|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
190615|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190616|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190617|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190618|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190619|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190620|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190621|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190622|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190623|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190624|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190625|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190626|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190627|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190628|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190629|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190630|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190631|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190632|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190633|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190634|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190635|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190636|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190637|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190638|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190639|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190640|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190641|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190642|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190643|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190644|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190645|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190646|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190647|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190648|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190649|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190650|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190651|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190652|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190653|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190654|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190655|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190656|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190657|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190658|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190659|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190660|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190661|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190662|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190663|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190664|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190665|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190666|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
220204|NCT01129921|B3|Baseline|Total|Total of all reporting groups
190667|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190668|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190669|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190670|NCT01222533|E5|Reported Event|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
190671|NCT01222533|E4|Reported Event|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
190672|NCT01222533|E3|Reported Event|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
190673|NCT01222533|E2|Reported Event|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
190674|NCT01222533|E1|Reported Event|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
190675|NCT01222520|B3|Baseline|Total|Total of all reporting groups
190676|NCT01222520|B2|Baseline|Telmisartan|
190677|NCT01222520|B1|Baseline|Telmisartan and Amlodipine FDC|
190678|NCT01222520|P2|Participant Flow|Telmisartan|
190679|NCT01222520|P1|Participant Flow|Telmisartan and Amlodipine FDC|
190680|NCT01222520|O2|Outcome|Telmisartan|
190681|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190682|NCT01222520|O2|Outcome|Telmisartan|
190683|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190684|NCT01222520|O2|Outcome|Telmisartan|
190685|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190686|NCT01222520|O2|Outcome|Telmisartan|
190687|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190688|NCT01222520|O2|Outcome|Telmisartan|
190689|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190690|NCT01222520|O2|Outcome|Telmisartan|
190691|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190692|NCT01222520|O2|Outcome|Telmisartan|
190693|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
190694|NCT01222520|E2|Reported Event|Telmisartan|
190695|NCT01222520|E1|Reported Event|Telmisartan and Amlodipine FDC|
190696|NCT01222507|B1|Baseline|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
190697|NCT01222507|P1|Participant Flow|Brain Speed Test (BST)|60 subjects who complete 60 Second Brain Game and Brain Speed Test
190698|NCT01222507|O1|Outcome|Brain Processing Speed|Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
190699|NCT01222507|E1|Reported Event|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
190700|NCT01222403|B3|Baseline|Total|Total of all reporting groups
190701|NCT01222403|B2|Baseline|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190702|NCT01222403|B1|Baseline|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190703|NCT01222403|P2|Participant Flow|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190704|NCT01222403|P1|Participant Flow|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190705|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190706|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190707|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190708|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190709|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190710|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190711|NCT01222403|E2|Reported Event|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190712|NCT01222403|E1|Reported Event|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
190713|NCT01222390|B1|Baseline|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
190714|NCT01222390|P1|Participant Flow|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
190715|NCT01222390|O1|Outcome|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
190812|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
190716|NCT01222390|E1|Reported Event|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
190717|NCT01222286|B3|Baseline|Total|Total of all reporting groups
190718|NCT01222286|B2|Baseline|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190719|NCT01222286|B1|Baseline|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190720|NCT01222286|P2|Participant Flow|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190721|NCT01222286|P1|Participant Flow|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190722|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190723|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190724|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190725|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190726|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190727|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190728|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190729|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190730|NCT01222286|E2|Reported Event|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190731|NCT01222286|E1|Reported Event|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
190732|NCT01222234|B4|Baseline|Total|Total of all reporting groups
190733|NCT01222234|B3|Baseline|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190734|NCT01222234|B2|Baseline|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
190735|NCT01222234|B1|Baseline|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190736|NCT01222234|P3|Participant Flow|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190737|NCT01222234|P2|Participant Flow|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
190738|NCT01222234|P1|Participant Flow|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190739|NCT01222234|O2|Outcome|Group 3: Non-CKD Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190740|NCT01222234|O1|Outcome|Group 1: CKD Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190741|NCT01222234|O2|Outcome|Group 2: Calcitriol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Calcitriol 0.25 mcg every day"
190742|NCT01222234|O1|Outcome|Group 1: Cholecalciferol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol 50,000 IU twice weekly for 8 weeks"
190743|NCT01222234|E3|Reported Event|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190744|NCT01222234|E2|Reported Event|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
190745|NCT01222234|E1|Reported Event|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
190746|NCT01222195|B1|Baseline|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
190747|NCT01222195|P1|Participant Flow|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
190748|NCT01222195|O1|Outcome|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
190749|NCT01222195|E1|Reported Event|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
190750|NCT01222117|B12|Baseline|Total|Total of all reporting groups
190751|NCT01222117|B11|Baseline|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190752|NCT01222117|B10|Baseline|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190753|NCT01222117|B9|Baseline|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190754|NCT01222117|B8|Baseline|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190755|NCT01222117|B7|Baseline|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190756|NCT01222117|B6|Baseline|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
190757|NCT01222117|B5|Baseline|Plasminogen Activator Blinded Group E|"PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
190758|NCT01222117|B4|Baseline|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190759|NCT01222117|B3|Baseline|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190760|NCT01222117|B2|Baseline|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190761|NCT01222117|B1|Baseline|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190762|NCT01222117|P11|Participant Flow|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190763|NCT01222117|P10|Participant Flow|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190764|NCT01222117|P9|Participant Flow|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190765|NCT01222117|P8|Participant Flow|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190766|NCT01222117|P7|Participant Flow|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190767|NCT01222117|P6|Participant Flow|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
190768|NCT01222117|P5|Participant Flow|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
190769|NCT01222117|P4|Participant Flow|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190770|NCT01222117|P3|Participant Flow|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190771|NCT01222117|P2|Participant Flow|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190772|NCT01222117|P1|Participant Flow|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190773|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190774|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190775|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190776|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190777|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190778|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
190779|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
190813|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
190780|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190781|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190782|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190783|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190784|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190785|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190786|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190787|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190788|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190789|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
190790|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
190791|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190792|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190793|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190794|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190795|NCT01222117|E11|Reported Event|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190796|NCT01222117|E10|Reported Event|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190797|NCT01222117|E9|Reported Event|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
190798|NCT01222117|E8|Reported Event|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190799|NCT01222117|E7|Reported Event|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190800|NCT01222117|E6|Reported Event|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
190801|NCT01222117|E5|Reported Event|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
190802|NCT01222117|E4|Reported Event|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190803|NCT01222117|E3|Reported Event|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190804|NCT01222117|E2|Reported Event|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
190805|NCT01222117|E1|Reported Event|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
190806|NCT01222104|B1|Baseline|All Participants|
190807|NCT01222104|P1|Participant Flow|All Participants|
190808|NCT01222104|O1|Outcome|Participants With Deployment|Participants with successful or attempted Angio-Seal deployments
190809|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
190810|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
190811|NCT01222104|O1|Outcome|All Participants|
190817|NCT01222104|O1|Outcome|Angio-Seal|Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.
190818|NCT01222104|O1|Outcome|Angio -Seal|Angio-Seal attempted and/or deployed group
190819|NCT01222104|E1|Reported Event|All Participants|
190820|NCT01221948|B1|Baseline|Deep Brain Stimulation|"Vercise (TM) Rechargeable Deep Brain Stimulation System~Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System"
190821|NCT01221948|P1|Participant Flow|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190822|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190823|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190824|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190825|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190826|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190827|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190828|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190829|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190830|NCT01221948|E1|Reported Event|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
190831|NCT01221753|B1|Baseline|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
190832|NCT01221753|P1|Participant Flow|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
190833|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
190834|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
190835|NCT01221753|E1|Reported Event|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
190836|NCT01221727|B3|Baseline|Total|Total of all reporting groups
190837|NCT01221727|B2|Baseline|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.
190838|NCT01221727|B1|Baseline|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.
190839|NCT01221727|P2|Participant Flow|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16.
190840|NCT01221727|P1|Participant Flow|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2
190841|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
190842|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
190843|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
190844|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
190845|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
190846|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
190847|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
190848|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
190849|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2
190850|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
190851|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
190852|NCT01221727|E6|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 16|
190853|NCT01221727|E5|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 2-15|
190854|NCT01221727|E4|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 1|
190855|NCT01221727|E3|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 16|
190856|NCT01221727|E2|Reported Event|Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15|
190857|NCT01221727|E1|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 1|
190858|NCT01221623|B3|Baseline|Total|Total of all reporting groups
190859|NCT01221623|B2|Baseline|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190860|NCT01221623|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190861|NCT01221623|P2|Participant Flow|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190862|NCT01221623|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190863|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190864|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190865|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190866|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190867|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190868|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190869|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190870|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190871|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190943|NCT01221363|B1|Baseline|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
190872|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190873|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190874|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190875|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190876|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190877|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190878|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190879|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190880|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190881|NCT01221623|E2|Reported Event|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190882|NCT01221623|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190883|NCT01221597|B3|Baseline|Total|Total of all reporting groups
190884|NCT01221597|B2|Baseline|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190885|NCT01221597|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190886|NCT01221597|P2|Participant Flow|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190887|NCT01221597|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190888|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190944|NCT01221363|P2|Participant Flow|Control Group|No intervention control group
191053|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
190889|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190890|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190891|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190892|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190893|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190894|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190895|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190896|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190897|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190898|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190899|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190900|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190901|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190902|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190903|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190904|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190945|NCT01221363|P1|Participant Flow|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
190905|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190906|NCT01221597|E2|Reported Event|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
190907|NCT01221597|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
190908|NCT01221441|B3|Baseline|Total|Total of all reporting groups
190909|NCT01221441|B2|Baseline|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190910|NCT01221441|B1|Baseline|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190911|NCT01221441|P2|Participant Flow|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190912|NCT01221441|P1|Participant Flow|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190913|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190914|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190915|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190916|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190917|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190918|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190919|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190920|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190921|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190922|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190923|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190924|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190925|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190926|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190927|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190928|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190929|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190930|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190931|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190932|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190933|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190934|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190935|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190936|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190937|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190938|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190939|NCT01221441|E2|Reported Event|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
190940|NCT01221441|E1|Reported Event|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
190941|NCT01221363|B3|Baseline|Total|Total of all reporting groups
190942|NCT01221363|B2|Baseline|Control Group|No intervention control group
190946|NCT01221363|O2|Outcome|Control Group|No intervention control group
191054|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191055|NCT01221090|O4|Outcome|Control|Usual Care
190947|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
190948|NCT01221363|O2|Outcome|Control Group|No intervention control group
190949|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
190950|NCT01221363|E2|Reported Event|Control Group|No intervention control group
190951|NCT01221363|E1|Reported Event|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
190952|NCT01221350|B3|Baseline|Total|Total of all reporting groups
190953|NCT01221350|B2|Baseline|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
190954|NCT01221350|B1|Baseline|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
190955|NCT01221350|P2|Participant Flow|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190956|NCT01221350|P1|Participant Flow|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190957|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190958|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190959|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190960|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190961|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190962|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190963|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190964|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190965|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
190966|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
190967|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190968|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190969|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190970|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190971|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190972|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190973|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190974|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190975|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190976|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190977|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190978|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190979|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190980|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190981|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190982|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190983|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
190984|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
190985|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190986|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190987|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
190988|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
190989|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190990|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190991|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190992|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190993|NCT01221350|E2|Reported Event|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
190994|NCT01221350|E1|Reported Event|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
190995|NCT01221298|B1|Baseline|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191050|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191051|NCT01221090|O4|Outcome|Control|Usual Care
190996|NCT01221298|P1|Participant Flow|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
190997|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
190998|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
190999|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191000|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191001|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191002|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191003|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191004|NCT01221298|E1|Reported Event|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
191005|NCT01221285|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
191006|NCT01221285|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191007|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191008|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191009|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191010|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191011|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191012|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191013|NCT01221285|E1|Reported Event|Experimental: German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
191014|NCT01221272|B1|Baseline|All Participants|"Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191015|NCT01221272|P2|Participant Flow|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191016|NCT01221272|P1|Participant Flow|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191017|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191018|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191052|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191019|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191020|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191021|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191022|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191023|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
191024|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
191025|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
191026|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
191027|NCT01221272|E3|Reported Event|Onset at Any Time Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191028|NCT01221272|E2|Reported Event|Onset Following Placebo|"This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191029|NCT01221272|E1|Reported Event|Onset Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
191030|NCT01221090|B5|Baseline|Total|Total of all reporting groups
191031|NCT01221090|B4|Baseline|Control|Usual Care
191032|NCT01221090|B3|Baseline|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191033|NCT01221090|B2|Baseline|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191034|NCT01221090|B1|Baseline|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191035|NCT01221090|P4|Participant Flow|Control|Usual Care
191036|NCT01221090|P3|Participant Flow|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191037|NCT01221090|P2|Participant Flow|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191038|NCT01221090|P1|Participant Flow|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191039|NCT01221090|O4|Outcome|Control|Usual Care
191040|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191041|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191042|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191043|NCT01221090|O4|Outcome|Control|Usual Care
191044|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191045|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191046|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191047|NCT01221090|O4|Outcome|Control|Usual Care
191048|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191049|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191056|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191057|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191058|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191059|NCT01221090|E4|Reported Event|Control|Usual Care
191060|NCT01221090|E3|Reported Event|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
191061|NCT01221090|E2|Reported Event|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
191062|NCT01221090|E1|Reported Event|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
191063|NCT01220869|B1|Baseline|Degarelix|Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
191064|NCT01220869|P1|Participant Flow|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191065|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191066|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191067|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191068|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191069|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191070|NCT01220869|E1|Reported Event|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
191071|NCT01220739|B3|Baseline|Total|Total of all reporting groups
191072|NCT01220739|B2|Baseline|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191073|NCT01220739|B1|Baseline|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191074|NCT01220739|P2|Participant Flow|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191075|NCT01220739|P1|Participant Flow|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191076|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191096|NCT01220557|E1|Reported Event|PRIMAS Group|"PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material~PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material"
191097|NCT01220466|B4|Baseline|Total|Total of all reporting groups
192072|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
191077|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191078|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191079|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191080|NCT01220739|E2|Reported Event|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191081|NCT01220739|E1|Reported Event|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
191082|NCT01220609|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191083|NCT01220609|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191084|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191085|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191086|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191087|NCT01220609|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
191088|NCT01220557|B3|Baseline|Total|Total of all reporting groups
191089|NCT01220557|B2|Baseline|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
191090|NCT01220557|B1|Baseline|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
191091|NCT01220557|P2|Participant Flow|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
191092|NCT01220557|P1|Participant Flow|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
191093|NCT01220557|O2|Outcome|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
191094|NCT01220557|O1|Outcome|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
191095|NCT01220557|E2|Reported Event|Control Group|"The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.~DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material."
191098|NCT01220466|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191099|NCT01220466|B2|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
191100|NCT01220466|B1|Baseline|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
191101|NCT01220466|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191102|NCT01220466|P2|Participant Flow|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
191103|NCT01220466|P1|Participant Flow|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
191104|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191105|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191106|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191107|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191108|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191109|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191110|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191111|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191112|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191113|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191114|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191115|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191116|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191117|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191118|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191119|NCT01220466|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
191120|NCT01220466|E2|Reported Event|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
191121|NCT01220466|E1|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
191122|NCT01220401|B1|Baseline|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191123|NCT01220401|P1|Participant Flow|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191124|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191125|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191126|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191127|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191128|NCT01220401|E1|Reported Event|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
191129|NCT01220180|B4|Baseline|Total|Total of all reporting groups
191130|NCT01220180|B3|Baseline|Pregabalin: Fibromyalgia|Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
191131|NCT01220180|B2|Baseline|Pregabalin: Neuropathic Pain|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
191132|NCT01220180|B1|Baseline|Pregabalin: Epilepsy|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
191133|NCT01220180|P1|Participant Flow|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191134|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191135|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191136|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191137|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191138|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191139|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191140|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191141|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191142|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191143|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191144|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191145|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191146|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191147|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191148|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191149|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
221210|NCT01126723|B3|Baseline|Total|Total of all reporting groups
191150|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191151|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191152|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191153|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191154|NCT01220180|E1|Reported Event|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
191155|NCT01219985|B1|Baseline|Investigation Arm|Patients included in the trial. n=50
191156|NCT01219985|P1|Participant Flow|Investigation Arm|Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
191157|NCT01219985|O1|Outcome|SUVmax Study|SUVmax measurement for each lesion in Ungated and CT-Based PET images. SUVmax was obtained automatically in a volume of interest encompassing the entire lesion
191158|NCT01219985|O2|Outcome|CT-Based Per-lesion Sensitivity|CT-Based PET images results were compared with pathological analyses
191159|NCT01219985|O1|Outcome|Ungated Per-lesion Sensitivity|Ungated PET images results were compared with pathological analyses
191160|NCT01219985|E1|Reported Event|Investigation Arm|Patients included in the trial. n=50
191161|NCT01219933|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191162|NCT01219933|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment
191163|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191164|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191165|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191166|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191234|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191167|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191168|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191169|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191170|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191171|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191172|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191173|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191174|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191175|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191176|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191235|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191177|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191178|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191179|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191180|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191181|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191182|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191183|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191184|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191185|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191186|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191236|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191187|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191188|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191189|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191190|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191191|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191192|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191193|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191194|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191195|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191196|NCT01219933|E2|Reported Event|Interventional Phase|All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
191237|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191238|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191197|NCT01219933|E1|Reported Event|Noninterventional Phase|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.
191198|NCT01219881|B3|Baseline|Total|Total of all reporting groups
191199|NCT01219881|B2|Baseline|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191200|NCT01219881|B1|Baseline|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191201|NCT01219881|P2|Participant Flow|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191202|NCT01219881|P1|Participant Flow|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Desflurane : 5.4 to 7.4% desflurane"
191203|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191204|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191205|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191206|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191207|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191208|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191209|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191210|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191211|NCT01219881|E2|Reported Event|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
191212|NCT01219881|E1|Reported Event|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
191213|NCT01219855|B6|Baseline|Total|Total of all reporting groups
191214|NCT01219855|B5|Baseline|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191215|NCT01219855|B4|Baseline|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191216|NCT01219855|B3|Baseline|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191217|NCT01219855|B2|Baseline|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191218|NCT01219855|B1|Baseline|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191219|NCT01219855|P5|Participant Flow|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191220|NCT01219855|P4|Participant Flow|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191221|NCT01219855|P3|Participant Flow|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191222|NCT01219855|P2|Participant Flow|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191223|NCT01219855|P1|Participant Flow|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191224|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191225|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191226|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191227|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191228|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191229|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191230|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191231|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191232|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191233|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191239|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191240|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191241|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191242|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191243|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191244|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191245|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191246|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191247|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191248|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191249|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191250|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191251|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191252|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191253|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191254|NCT01219855|E4|Reported Event|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
191255|NCT01219855|E3|Reported Event|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
191256|NCT01219855|E2|Reported Event|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
191257|NCT01219855|E1|Reported Event|Cohorts 1,2: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
191258|NCT01219777|B1|Baseline|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
191259|NCT01219777|P1|Participant Flow|Carboplatin + Weekly Paclitaxel and Bevacizumab|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
191260|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
191261|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
191296|NCT01219673|O5|Outcome|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
191297|NCT01219673|O4|Outcome|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
191298|NCT01219673|O3|Outcome|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
191262|NCT01219777|E1|Reported Event|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
191263|NCT01219738|B1|Baseline|Asthma|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
191264|NCT01219738|P1|Participant Flow|All Study Participants|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
191265|NCT01219738|O5|Outcome|Placebo|A single inhaled dose of placebo from a DPI
191266|NCT01219738|O4|Outcome|720ug of Budesonide 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
191267|NCT01219738|O3|Outcome|Budesonide 1440 ug|Budesonide: A single inhaled dose of 1440ug budesonide from a DPI.
191268|NCT01219738|O2|Outcome|Budesonide 720 ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
191269|NCT01219738|O1|Outcome|Budesonide 360 ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
191270|NCT01219738|O5|Outcome|Placebo|Placebo: A single inhaled dose of placebo from a DPI
191271|NCT01219738|O4|Outcome|Budesonide 720ug 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
191272|NCT01219738|O3|Outcome|Budesonide 1440ug|Budesonide: A single dose of 1440ug of the budesonide from DPI.
191273|NCT01219738|O2|Outcome|Budesonide 720ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
191274|NCT01219738|O1|Outcome|Budesonide 360ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
191275|NCT01219738|E1|Reported Event|All Study Participants|Budesonide:was given in different doses
191276|NCT01219673|B9|Baseline|Total|Total of all reporting groups
191277|NCT01219673|B8|Baseline|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191278|NCT01219673|B7|Baseline|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191279|NCT01219673|B6|Baseline|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
191280|NCT01219673|B5|Baseline|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
191281|NCT01219673|B4|Baseline|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
191282|NCT01219673|B3|Baseline|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
191283|NCT01219673|B2|Baseline|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
191284|NCT01219673|B1|Baseline|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
191285|NCT01219673|P8|Participant Flow|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191286|NCT01219673|P7|Participant Flow|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191287|NCT01219673|P6|Participant Flow|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
191288|NCT01219673|P5|Participant Flow|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
191289|NCT01219673|P4|Participant Flow|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
191290|NCT01219673|P3|Participant Flow|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
191291|NCT01219673|P2|Participant Flow|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
191292|NCT01219673|P1|Participant Flow|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
191293|NCT01219673|O8|Outcome|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191294|NCT01219673|O7|Outcome|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191295|NCT01219673|O6|Outcome|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
225881|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
191299|NCT01219673|O2|Outcome|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
191300|NCT01219673|O1|Outcome|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
191301|NCT01219673|E8|Reported Event|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191302|NCT01219673|E7|Reported Event|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
191303|NCT01219673|E6|Reported Event|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
191304|NCT01219673|E5|Reported Event|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
191305|NCT01219673|E4|Reported Event|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
191306|NCT01219673|E3|Reported Event|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
191307|NCT01219673|E2|Reported Event|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
191308|NCT01219673|E1|Reported Event|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
191309|NCT01218997|B3|Baseline|Total|Total of all reporting groups
191310|NCT01218997|B2|Baseline|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
191311|NCT01218997|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
191312|NCT01218997|P2|Participant Flow|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
191313|NCT01218997|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
191314|NCT01218997|O2|Outcome|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
191315|NCT01218997|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
191316|NCT01218997|E2|Reported Event|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
191317|NCT01218997|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
191318|NCT01218984|B4|Baseline|Total|Total of all reporting groups
191319|NCT01218984|B3|Baseline|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
191320|NCT01218984|B2|Baseline|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
191321|NCT01218984|B1|Baseline|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
191322|NCT01218984|P3|Participant Flow|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
191323|NCT01218984|P2|Participant Flow|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
191324|NCT01218984|P1|Participant Flow|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
191325|NCT01218984|O3|Outcome|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
191326|NCT01218984|O2|Outcome|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
191327|NCT01218984|O1|Outcome|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
191328|NCT01218984|E3|Reported Event|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
191329|NCT01218984|E2|Reported Event|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
191330|NCT01218984|E1|Reported Event|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
191331|NCT01218971|B3|Baseline|Total|Total of all reporting groups
191332|NCT01218971|B2|Baseline|Medisorb Naltrexone 190 mg|
191333|NCT01218971|B1|Baseline|Medisorb Naltrexone 380 mg|
191334|NCT01218971|P2|Participant Flow|Medisorb Naltrexone 190 mg|
191335|NCT01218971|P1|Participant Flow|Medisorb Naltrexone 380 mg|
191336|NCT01218971|O2|Outcome|Medisorb Naltrexone 190 mg|
191337|NCT01218971|O1|Outcome|Medisorb Naltrexone 380 mg|
191338|NCT01218971|E6|Reported Event|190mg to 190mg|includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191339|NCT01218971|E5|Reported Event|Placebo to 190mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191340|NCT01218971|E4|Reported Event|380mg to 380mg|Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191341|NCT01218971|E3|Reported Event|Placebo to 380mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191342|NCT01218971|E2|Reported Event|Medisorb Naltrexone 190mg--Combined|Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191343|NCT01218971|E1|Reported Event|Medisorb Naltrexone 380mg--Combined|Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
191344|NCT01218958|B4|Baseline|Total|Total of all reporting groups
191345|NCT01218958|B3|Baseline|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
191346|NCT01218958|B2|Baseline|Medisorb Naltrexone 380 mg|
191347|NCT01218958|B1|Baseline|Medisorb Naltrexone 190 mg|
191735|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
191348|NCT01218958|P3|Participant Flow|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
191349|NCT01218958|P2|Participant Flow|Medisorb Naltrexone 380 mg|
191350|NCT01218958|P1|Participant Flow|Medisorb Naltrexone 190 mg|
191351|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
191352|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
191353|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
191354|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
191355|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
191356|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
191357|NCT01218958|E3|Reported Event|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
191358|NCT01218958|E2|Reported Event|Medisorb Naltrexone 380 mg|
191359|NCT01218958|E1|Reported Event|Medisorb Naltrexone 190 mg|
191360|NCT01218867|B12|Baseline|Total|Total of all reporting groups
191361|NCT01218867|B11|Baseline|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191362|NCT01218867|B10|Baseline|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191363|NCT01218867|B9|Baseline|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191364|NCT01218867|B8|Baseline|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191365|NCT01218867|B7|Baseline|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191366|NCT01218867|B6|Baseline|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191445|NCT01218646|P2|Participant Flow|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191446|NCT01218646|P1|Participant Flow|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191447|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191367|NCT01218867|B5|Baseline|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191368|NCT01218867|B4|Baseline|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191369|NCT01218867|B3|Baseline|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191370|NCT01218867|B2|Baseline|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191371|NCT01218867|B1|Baseline|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191372|NCT01218867|P11|Participant Flow|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191373|NCT01218867|P10|Participant Flow|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191374|NCT01218867|P9|Participant Flow|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
225882|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
191375|NCT01218867|P8|Participant Flow|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191376|NCT01218867|P7|Participant Flow|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191377|NCT01218867|P6|Participant Flow|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191378|NCT01218867|P5|Participant Flow|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191379|NCT01218867|P4|Participant Flow|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191380|NCT01218867|P3|Participant Flow|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191381|NCT01218867|P2|Participant Flow|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191382|NCT01218867|P1|Participant Flow|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191383|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191384|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191385|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191386|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191387|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191388|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191389|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191390|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191736|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
191391|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191392|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191393|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191394|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191395|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191396|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191397|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191398|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
225883|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
191399|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191400|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191401|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191402|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191403|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191404|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191405|NCT01218867|O11|Outcome|Cohort 11 - 3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191406|NCT01218867|O10|Outcome|Cohort 10 - 1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
225884|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
191407|NCT01218867|O9|Outcome|Cohort 9 - 3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191408|NCT01218867|O8|Outcome|Cohort 8 - 1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191409|NCT01218867|O7|Outcome|Cohort 7 - 1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191410|NCT01218867|O6|Outcome|Cohort 6 - 3x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191411|NCT01218867|O5|Outcome|Cohort 5 - 1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191412|NCT01218867|O4|Outcome|Cohort 4 - 3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191413|NCT01218867|O3|Outcome|Cohort 3 - 1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191414|NCT01218867|O2|Outcome|Cohort 2 - 3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191737|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
191415|NCT01218867|O1|Outcome|Cohort 1 - 1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191416|NCT01218867|E11|Reported Event|Cohort 11 (3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191417|NCT01218867|E10|Reported Event|Cohort 10 (1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191418|NCT01218867|E9|Reported Event|Cohort 9 (3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191419|NCT01218867|E8|Reported Event|Cohort 8 (1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191420|NCT01218867|E7|Reported Event|Cohort 7 (1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191421|NCT01218867|E6|Reported Event|Cohort 6 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191422|NCT01218867|E5|Reported Event|Cohort 5 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
225885|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
191423|NCT01218867|E4|Reported Event|Cohort 4 (3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191424|NCT01218867|E3|Reported Event|Cohort 3 (1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191425|NCT01218867|E2|Reported Event|Cohort 2 (3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191426|NCT01218867|E1|Reported Event|Cohort 1 (1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
191427|NCT01218802|B3|Baseline|Total|Total of all reporting groups
191428|NCT01218802|B2|Baseline|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
191429|NCT01218802|B1|Baseline|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
191430|NCT01218802|P2|Participant Flow|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
191431|NCT01218802|P1|Participant Flow|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
191432|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
191433|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
191434|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
191435|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
191436|NCT01218802|E2|Reported Event|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
191437|NCT01218802|E1|Reported Event|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
191438|NCT01218646|B5|Baseline|Total|Total of all reporting groups
191439|NCT01218646|B4|Baseline|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191440|NCT01218646|B3|Baseline|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
191441|NCT01218646|B2|Baseline|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191442|NCT01218646|B1|Baseline|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191443|NCT01218646|P4|Participant Flow|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
191444|NCT01218646|P3|Participant Flow|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191448|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191449|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191450|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191451|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191452|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191453|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191454|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191455|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191456|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191457|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191458|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191459|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191460|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191461|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191462|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191463|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191464|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191465|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191466|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191467|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191468|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191469|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191470|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191471|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191472|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191473|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191474|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191475|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191476|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191477|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191478|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191479|NCT01218646|E4|Reported Event|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
191480|NCT01218646|E3|Reported Event|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
191481|NCT01218646|E2|Reported Event|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
191482|NCT01218646|E1|Reported Event|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
191483|NCT01218594|B1|Baseline|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
191484|NCT01218594|P1|Participant Flow|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
225886|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
191485|NCT01218594|O1|Outcome|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
191486|NCT01218594|E1|Reported Event|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
191487|NCT01218477|B5|Baseline|Total|Total of all reporting groups
191488|NCT01218477|B4|Baseline|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191489|NCT01218477|B3|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191490|NCT01218477|B2|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), plus BMS-833923, 50 mg, QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191491|NCT01218477|B1|Baseline|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
191492|NCT01218477|P4|Participant Flow|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191493|NCT01218477|P3|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191494|NCT01218477|P2|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg QD
191495|NCT01218477|P1|Participant Flow|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
191496|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191497|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days, followed by dasatinib, 100/140 mg once daily (QD)
191498|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
191499|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
191500|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191501|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191502|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
191503|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
191504|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
191505|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
191506|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
191507|NCT01218477|E4|Reported Event|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191530|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
225887|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
191508|NCT01218477|E3|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatanib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191509|NCT01218477|E2|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatanib, 100/140 mg once daily (QD), as oral tablets plus BMS-833923, 50 mg, QD (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191510|NCT01218477|E1|Reported Event|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
191511|NCT01218438|B1|Baseline|Study Epochs 1-4|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191512|NCT01218438|P1|Participant Flow|Study Participants|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191513|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191514|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191515|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191516|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191517|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191518|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191519|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191520|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191521|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191522|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191523|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191524|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191525|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191526|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191527|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191528|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191529|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191531|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191532|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191533|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191534|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191535|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191536|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191537|NCT01218438|O6|Outcome|CHANGE END EPOCH 1 TO END EPOCH 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191538|NCT01218438|O5|Outcome|CHANGE END EPOCH 1 TO END EPOCH 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191539|NCT01218438|O4|Outcome|END OF STUDY EPOCH 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191540|NCT01218438|O3|Outcome|END OF STUDY EPOCH 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191541|NCT01218438|O2|Outcome|END OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191542|NCT01218438|O1|Outcome|START OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191543|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191544|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191545|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191546|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191547|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191548|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191549|NCT01218438|O6|Outcome|Change End Epoch 1 to End Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191550|NCT01218438|O5|Outcome|Change End Epoch 1 to End Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191551|NCT01218438|O4|Outcome|End of Study Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
191552|NCT01218438|O3|Outcome|End of Study Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
191553|NCT01218438|O2|Outcome|End of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191554|NCT01218438|O1|Outcome|Start of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191555|NCT01218438|O2|Outcome|Subcutaneous 20%|
191556|NCT01218438|O1|Outcome|Intravenous 10%|
191557|NCT01218438|O2|Outcome|Subcutaneous 20%|
191558|NCT01218438|O1|Outcome|Intravenous 10%|
191559|NCT01218438|O2|Outcome|Subcutaneous 20%|
191560|NCT01218438|O1|Outcome|Intravenous 10%|
191561|NCT01218438|O2|Outcome|Subcutaneous 20%|
191562|NCT01218438|O1|Outcome|Intravenous 10%|
191563|NCT01218438|O2|Outcome|Subcutaneous 20%|
191564|NCT01218438|O1|Outcome|Intravenous 10%|
191565|NCT01218438|O2|Outcome|Subcutaneous 20%|
191566|NCT01218438|O1|Outcome|Intravenous 10%|
191567|NCT01218438|O2|Outcome|Subcutaneous 20%|
191568|NCT01218438|O1|Outcome|Intravenous 10%|
191588|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191589|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191590|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191591|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191592|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191593|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191594|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191595|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191596|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191597|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191598|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191599|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191600|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191601|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191602|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191603|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191604|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191605|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191606|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191607|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191738|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
191739|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
191608|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191609|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191610|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191611|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191612|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191613|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191614|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191615|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191616|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191617|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191618|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191619|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191620|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191621|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191622|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Week|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191623|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191624|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191625|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191626|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191627|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191740|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
225888|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
191628|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
191629|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
191630|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191631|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
191632|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
191633|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Immune globulin administered subcutaneously (IGSC)"
191634|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
191635|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
191636|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191637|NCT01218438|O1|Outcome|Overall Study Arm|
191638|NCT01218438|O1|Outcome|Overall Study Arm|
191639|NCT01218438|O5|Outcome|SC 20% Individualized 1 Week|
191640|NCT01218438|O4|Outcome|SC 20% Adjusted 1 Week|
191641|NCT01218438|O3|Outcome|SC 20% 145% IV 1 Week|
191642|NCT01218438|O2|Outcome|IV 10% 4 Weeks|
191643|NCT01218438|O1|Outcome|IV 10% 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191644|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191645|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191646|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191741|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
191742|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
191647|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191648|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
191649|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191650|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191651|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191652|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191653|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191654|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191655|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191656|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191657|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191658|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191659|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
191743|NCT01218100|E4|Reported Event|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
191744|NCT01218100|E3|Reported Event|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
191660|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
191661|NCT01218438|O1|Outcome|Study Participants|
191662|NCT01218438|E2|Reported Event|Study Epochs 2-4: Subcutaneous 20% Treatment|
191663|NCT01218438|E1|Reported Event|Study Epoch 1: Intravenous 10% Treatment|
191664|NCT01218308|B3|Baseline|Total|Total of all reporting groups
191665|NCT01218308|B2|Baseline|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191666|NCT01218308|B1|Baseline|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191667|NCT01218308|P2|Participant Flow|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191668|NCT01218308|P1|Participant Flow|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191669|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191670|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191671|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191672|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191673|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191674|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191675|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191676|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191677|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191678|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191679|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191680|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191681|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191682|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191683|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191684|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191685|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191686|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191687|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191688|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191689|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191690|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191691|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191692|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191693|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191694|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191695|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191696|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191697|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191698|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191699|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191700|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191701|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191702|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191703|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191745|NCT01218100|E2|Reported Event|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
191746|NCT01218100|E1|Reported Event|Placebo|Placebo group - starting dose is placebo
191747|NCT01218087|B3|Baseline|Total|Total of all reporting groups
191704|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191705|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191706|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191707|NCT01218308|E2|Reported Event|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191708|NCT01218308|E1|Reported Event|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
191709|NCT01218243|B3|Baseline|Total|Total of all reporting groups
191710|NCT01218243|B2|Baseline|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191711|NCT01218243|B1|Baseline|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191712|NCT01218243|P2|Participant Flow|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191713|NCT01218243|P1|Participant Flow|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191714|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191715|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191716|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191748|NCT01218087|B2|Baseline|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
191749|NCT01218087|B1|Baseline|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant
191750|NCT01218087|P2|Participant Flow|Moldable Positioner Device|Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
191717|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191718|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191719|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191720|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191721|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191722|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191723|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191724|NCT01218243|E2|Reported Event|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191725|NCT01218243|E1|Reported Event|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
191726|NCT01218100|B5|Baseline|Total|Total of all reporting groups
191727|NCT01218100|B4|Baseline|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
191728|NCT01218100|B3|Baseline|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
191729|NCT01218100|B2|Baseline|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
191730|NCT01218100|B1|Baseline|Placebo|Placebo group - starting dose is placebo
191731|NCT01218100|P4|Participant Flow|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
191732|NCT01218100|P3|Participant Flow|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
191733|NCT01218100|P2|Participant Flow|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
191734|NCT01218100|P1|Participant Flow|Placebo|Placebo group - starting dose is placebo
191751|NCT01218087|P1|Participant Flow|Cranial Cup Device|The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.
191752|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
191753|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
191754|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
191755|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
191756|NCT01218087|E2|Reported Event|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
191757|NCT01218087|E1|Reported Event|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
191758|NCT01218009|B3|Baseline|Total|Total of all reporting groups
191759|NCT01218009|B2|Baseline|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191760|NCT01218009|B1|Baseline|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191761|NCT01218009|P2|Participant Flow|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191762|NCT01218009|P1|Participant Flow|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191763|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191764|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191765|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191766|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191767|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191768|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191769|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191770|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191771|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191849|NCT01217944|P2|Participant Flow|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191772|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191773|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191774|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191775|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191776|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191777|NCT01218009|E2|Reported Event|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191778|NCT01218009|E1|Reported Event|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
191779|NCT01217957|B6|Baseline|Total|Total of all reporting groups
191780|NCT01217957|B5|Baseline|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191781|NCT01217957|B4|Baseline|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191782|NCT01217957|B3|Baseline|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191783|NCT01217957|B2|Baseline|Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191784|NCT01217957|B1|Baseline|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191785|NCT01217957|P5|Participant Flow|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191786|NCT01217957|P4|Participant Flow|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191787|NCT01217957|P3|Participant Flow|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191816|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191788|NCT01217957|P2|Participant Flow|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191789|NCT01217957|P1|Participant Flow|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191790|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191791|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191792|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191793|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191794|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191795|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191796|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191797|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191798|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191799|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191800|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191801|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
192073|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
191802|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191803|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191804|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191805|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191806|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191807|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191808|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191809|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191810|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191811|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191812|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191813|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191814|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191815|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191953|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191817|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191818|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191819|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191820|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191821|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191822|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191823|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191824|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191825|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191826|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191827|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191828|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191829|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191830|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191847|NCT01217944|B1|Baseline|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191848|NCT01217944|P3|Participant Flow|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191831|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191832|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
191833|NCT01217957|O1|Outcome|Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191834|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191835|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191836|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m^2 in Phase 1.
191837|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191838|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191839|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191840|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191841|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191842|NCT01217957|E2|Reported Event|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191843|NCT01217957|E1|Reported Event|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
191844|NCT01217944|B4|Baseline|Total|Total of all reporting groups
191845|NCT01217944|B3|Baseline|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191846|NCT01217944|B2|Baseline|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
192074|NCT01217112|O5|Outcome|Placebo|Contains excipients only
191850|NCT01217944|P1|Participant Flow|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191851|NCT01217944|O1|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191852|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191853|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191854|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191855|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191856|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191857|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191858|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191859|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191860|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191861|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191862|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191863|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191864|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191865|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191866|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191867|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191868|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191869|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191870|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191871|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191872|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191873|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191874|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191875|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191876|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191877|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191878|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191879|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191880|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191881|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
191882|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191954|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191883|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191884|NCT01217944|E4|Reported Event|Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3|After month 3 participants did not receive active ranibizumab
191885|NCT01217944|E3|Reported Event|Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3|After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed.
191886|NCT01217944|E2|Reported Event|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
191887|NCT01217944|E1|Reported Event|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
191888|NCT01217892|B5|Baseline|Total|Total of all reporting groups
191889|NCT01217892|B4|Baseline|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191890|NCT01217892|B3|Baseline|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191891|NCT01217892|B2|Baseline|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191892|NCT01217892|B1|Baseline|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191893|NCT01217892|P4|Participant Flow|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191894|NCT01217892|P3|Participant Flow|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191895|NCT01217892|P2|Participant Flow|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191896|NCT01217892|P1|Participant Flow|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191897|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191898|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191899|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191900|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191901|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191902|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191903|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191904|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191905|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191906|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191907|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191908|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191909|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191910|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191911|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191912|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191913|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191914|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191915|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191916|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191917|NCT01217892|E4|Reported Event|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
191918|NCT01217892|E3|Reported Event|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191919|NCT01217892|E2|Reported Event|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191920|NCT01217892|E1|Reported Event|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
191921|NCT01217840|B3|Baseline|Total|Total of all reporting groups
191922|NCT01217840|B2|Baseline|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
191955|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191956|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191923|NCT01217840|B1|Baseline|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
191924|NCT01217840|P2|Participant Flow|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
191925|NCT01217840|P1|Participant Flow|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
191926|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
191927|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
191928|NCT01217840|E2|Reported Event|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
191929|NCT01217840|E1|Reported Event|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
191930|NCT01217827|B3|Baseline|Total|Total of all reporting groups
191931|NCT01217827|B2|Baseline|Control|This group does not receive an intervention.
191932|NCT01217827|B1|Baseline|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
191933|NCT01217827|P2|Participant Flow|Control|This group does not receive an intervention.
191934|NCT01217827|P1|Participant Flow|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
191935|NCT01217827|O2|Outcome|Control|This group does not receive an intervention.
191936|NCT01217827|O1|Outcome|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
191937|NCT01217827|E2|Reported Event|Control|This group does not receive an intervention.
191938|NCT01217827|E1|Reported Event|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
191939|NCT01217749|B4|Baseline|Total|Total of all reporting groups
191940|NCT01217749|B3|Baseline|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191941|NCT01217749|B2|Baseline|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191942|NCT01217749|B1|Baseline|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191943|NCT01217749|P3|Participant Flow|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191944|NCT01217749|P2|Participant Flow|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191945|NCT01217749|P1|Participant Flow|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191946|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191947|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191948|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191949|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191950|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191951|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191952|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
192066|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
191957|NCT01217749|E3|Reported Event|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
191958|NCT01217749|E2|Reported Event|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
191959|NCT01217749|E1|Reported Event|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
191960|NCT01217606|B3|Baseline|Total|Total of all reporting groups
191961|NCT01217606|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
191962|NCT01217606|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
191963|NCT01217606|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
191964|NCT01217606|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
191965|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
191966|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
191967|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
191968|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
191969|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
191970|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
191971|NCT01217606|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
191972|NCT01217606|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
191973|NCT01217515|B4|Baseline|Total|Total of all reporting groups
191974|NCT01217515|B3|Baseline|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191975|NCT01217515|B2|Baseline|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191976|NCT01217515|B1|Baseline|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191977|NCT01217515|P3|Participant Flow|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191978|NCT01217515|P2|Participant Flow|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191979|NCT01217515|P1|Participant Flow|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191980|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191981|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191982|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191983|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191984|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191985|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191986|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191987|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191988|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191989|NCT01217515|E3|Reported Event|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
191990|NCT01217515|E2|Reported Event|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
191991|NCT01217515|E1|Reported Event|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
191992|NCT01217476|B3|Baseline|Total|Total of all reporting groups
191993|NCT01217476|B2|Baseline|Placebo|Matching placebo spray
191994|NCT01217476|B1|Baseline|Trafermin|Trafermin 0.01% spray
191995|NCT01217476|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
191996|NCT01217476|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
191997|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
191998|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
191999|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
192000|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
192001|NCT01217476|E2|Reported Event|Placebo|Matching placebo spray
192002|NCT01217476|E1|Reported Event|Trafermin|Trafermin 0.01% spray
192003|NCT01217463|B3|Baseline|Total|Total of all reporting groups
192004|NCT01217463|B2|Baseline|Placebo|Matching placebo spray
192005|NCT01217463|B1|Baseline|Trafermin|Trafermin 0.01% spray
192006|NCT01217463|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
192007|NCT01217463|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
192008|NCT01217463|O2|Outcome|Matching Placebo Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
192009|NCT01217463|O1|Outcome|Trafermin 0.01% Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
192010|NCT01217463|O2|Outcome|Placebo|Matching placebo spray
192011|NCT01217463|O1|Outcome|Trafermin|Trafermin 0.01% spray
192012|NCT01217463|E2|Reported Event|Placebo|Matching placebo spray
192013|NCT01217463|E1|Reported Event|Trafermin|Trafermin 0.01% spray
192014|NCT01217411|B4|Baseline|Total|Total of all reporting groups
192015|NCT01217411|B3|Baseline|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: MTD Dosing cohorts: 5 mg, 10 mg and 20 mg given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
192016|NCT01217411|B2|Baseline|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo Whole-Brain Radiotherapy (WBRT) as in phase I and patients with =< 3 brain lesions undergo Stereotactic Radiosurgery (SRS) as in phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
192017|NCT01217411|B1|Baseline|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
192018|NCT01217411|P3|Participant Flow|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in Phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in Phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: Maximum tolerated dose (MTD) derived from Phase I given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
192067|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192068|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192019|NCT01217411|P2|Participant Flow|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo WBRT as in Phase I and patients with =< 3 brain lesions undergo SRS as in Phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
192020|NCT01217411|P1|Participant Flow|Phase I MTD Arm|"RO4929097 starting dose oral 5 mg; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I Whole-Brain Radiotherapy (WBRT) + RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I Stereotactic Radiosurgery (SRS) + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~SRS: Radiosurgery 20 Gray (Gy) for tumors up to 1 cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions. WBRT: Radiotherapy 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for SRS"
192021|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
192022|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
192023|NCT01217411|E1|Reported Event|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
192024|NCT01217229|B1|Baseline|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
192025|NCT01217229|P1|Participant Flow|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
192026|NCT01217229|O1|Outcome|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
192027|NCT01217229|E1|Reported Event|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
192028|NCT01217112|B6|Baseline|Total|Total of all reporting groups
192029|NCT01217112|B5|Baseline|Placebo|Contains excipients only
192030|NCT01217112|B4|Baseline|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192031|NCT01217112|B3|Baseline|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192032|NCT01217112|B2|Baseline|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192033|NCT01217112|B1|Baseline|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192034|NCT01217112|P5|Participant Flow|Placebo|Contains excipients only
192035|NCT01217112|P4|Participant Flow|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192036|NCT01217112|P3|Participant Flow|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192037|NCT01217112|P2|Participant Flow|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192038|NCT01217112|P1|Participant Flow|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192039|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192040|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192041|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192042|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192043|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192044|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192045|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192046|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192047|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192048|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192049|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192050|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192051|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192052|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192053|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192054|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192055|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192056|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192057|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192058|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192059|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192060|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192061|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192062|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192063|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192064|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192065|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192075|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192076|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192077|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192078|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192079|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192080|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192081|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192082|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192083|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192084|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192085|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192086|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192087|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192088|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192089|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192090|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192091|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192092|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192093|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192094|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192095|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192096|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192097|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192098|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192099|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192100|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192101|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192102|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192103|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192104|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192105|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192106|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192107|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192108|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192109|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192110|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192111|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192112|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192113|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192114|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192115|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192116|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192117|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192118|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192119|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192120|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192121|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192122|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192123|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192124|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192125|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192126|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192127|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192128|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192129|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192130|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192131|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192132|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192133|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192134|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192135|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192136|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192137|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192138|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192139|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192140|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192141|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192142|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192143|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192144|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192145|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192146|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192147|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192148|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192149|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192150|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192151|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192152|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192153|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192154|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192155|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192156|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192157|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192158|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192159|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192160|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192161|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192162|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192163|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192164|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192165|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192166|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192167|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192168|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192169|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192170|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192171|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192172|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192173|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192174|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192175|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192176|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192177|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192178|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192179|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192180|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192181|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192182|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192183|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192184|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192185|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192186|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192187|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192188|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192189|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192190|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192191|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192192|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192193|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192194|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192195|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192196|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192197|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192198|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192199|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192200|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192201|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192202|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192203|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192204|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192205|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192206|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192207|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192208|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192210|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192211|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192212|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192213|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192214|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192215|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192216|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192217|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192218|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192219|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192220|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192221|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192222|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192223|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192224|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192225|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192226|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192227|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192228|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192229|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192230|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192231|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192232|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192233|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192234|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192235|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192236|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192237|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192238|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192239|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192240|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192241|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192242|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192243|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192244|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192245|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192246|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192247|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192248|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192249|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192250|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192251|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192252|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192253|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192254|NCT01217112|O5|Outcome|Placebo|Contains excipients only
192255|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192256|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192257|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192258|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192259|NCT01217112|E5|Reported Event|Placebo|Contains excipients only
192260|NCT01217112|E4|Reported Event|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
192261|NCT01217112|E3|Reported Event|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
192262|NCT01217112|E2|Reported Event|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
192263|NCT01217112|E1|Reported Event|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
192264|NCT01217073|B7|Baseline|Total|Total of all reporting groups
192265|NCT01217073|B6|Baseline|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192266|NCT01217073|B5|Baseline|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192267|NCT01217073|B4|Baseline|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192268|NCT01217073|B3|Baseline|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192269|NCT01217073|B2|Baseline|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192270|NCT01217073|B1|Baseline|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192271|NCT01217073|P8|Participant Flow|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
225889|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
192272|NCT01217073|P7|Participant Flow|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
192273|NCT01217073|P6|Participant Flow|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192274|NCT01217073|P5|Participant Flow|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192275|NCT01217073|P4|Participant Flow|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192276|NCT01217073|P3|Participant Flow|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192277|NCT01217073|P2|Participant Flow|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192278|NCT01217073|P1|Participant Flow|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192279|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
192280|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192281|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192282|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192283|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192284|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192285|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192286|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192287|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
192288|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192289|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192290|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192291|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192292|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192293|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192294|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192295|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
192296|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192297|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192298|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192299|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192300|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
192301|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192302|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192303|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192304|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192305|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192306|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192307|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192308|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192309|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192310|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192311|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192312|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192313|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192314|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192315|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192316|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192317|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192318|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192319|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192320|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192321|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192322|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192323|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192324|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192325|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192326|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192327|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192328|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192329|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192330|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192331|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192332|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192333|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192334|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192335|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192336|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192337|NCT01217073|E8|Reported Event|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
192338|NCT01217073|E7|Reported Event|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
192339|NCT01217073|E6|Reported Event|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
192340|NCT01217073|E5|Reported Event|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
192341|NCT01217073|E4|Reported Event|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
192342|NCT01217073|E3|Reported Event|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
192343|NCT01217073|E2|Reported Event|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
192344|NCT01217073|E1|Reported Event|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
192345|NCT01216943|B1|Baseline|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
192346|NCT01216943|P1|Participant Flow|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
192347|NCT01216943|O1|Outcome|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
192348|NCT01216943|E1|Reported Event|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
192349|NCT01216761|B1|Baseline|Total Population|
192350|NCT01216761|P3|Participant Flow|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
192351|NCT01216761|P2|Participant Flow|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
192352|NCT01216761|P1|Participant Flow|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
192353|NCT01216761|O3|Outcome|Povidone Iodine (PI)|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
192354|NCT01216761|O2|Outcome|Iodine Tincture (IT)|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
192355|NCT01216761|O1|Outcome|Chlorhexidine Gluconate (CHG_|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
192356|NCT01216761|E3|Reported Event|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
192357|NCT01216761|E2|Reported Event|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
192358|NCT01216761|E1|Reported Event|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
192359|NCT01216748|B1|Baseline|Controls|health-lifetime non-smokers were enrolled
192360|NCT01216748|P1|Participant Flow|All Study Participants|healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
192361|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
192362|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
192363|NCT01216748|E1|Reported Event|Health Controls|Health lifetime non smokers were recruited.
192364|NCT01216735|B3|Baseline|Total|Total of all reporting groups
192365|NCT01216735|B2|Baseline|Non-smokers|this group served as controls for baseline data. No intervention or treatment were assigned to this group.
192366|NCT01216735|B1|Baseline|Smokers|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
192367|NCT01216735|P2|Participant Flow|Placebo First, Then Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
192368|NCT01216735|P1|Participant Flow|Fluticasone First, Then Placebo|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
192369|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
192370|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
192371|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
192372|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
192373|NCT01216735|E2|Reported Event|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
192374|NCT01216735|E1|Reported Event|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
192375|NCT01216631|B4|Baseline|Total|Total of all reporting groups
192376|NCT01216631|B3|Baseline|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
192377|NCT01216631|B2|Baseline|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
192378|NCT01216631|B1|Baseline|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
192379|NCT01216631|P3|Participant Flow|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
192380|NCT01216631|P2|Participant Flow|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
192381|NCT01216631|P1|Participant Flow|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
192382|NCT01216631|O3|Outcome|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
192383|NCT01216631|O2|Outcome|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
192384|NCT01216631|O1|Outcome|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
192385|NCT01216631|E3|Reported Event|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
192386|NCT01216631|E2|Reported Event|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
192387|NCT01216631|E1|Reported Event|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
192388|NCT01216410|B4|Baseline|Total|Total of all reporting groups
192389|NCT01216410|B3|Baseline|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192390|NCT01216410|B2|Baseline|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192391|NCT01216410|B1|Baseline|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192392|NCT01216410|P3|Participant Flow|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192393|NCT01216410|P2|Participant Flow|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192394|NCT01216410|P1|Participant Flow|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192395|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192396|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192397|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192398|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192399|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192400|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192401|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192402|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192403|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192404|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192405|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192406|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192407|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192408|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192409|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192410|NCT01216410|E3|Reported Event|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
192411|NCT01216410|E2|Reported Event|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
192412|NCT01216410|E1|Reported Event|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
192413|NCT01216397|B1|Baseline|All Participants|Treatment with standard batch and side batch
192414|NCT01216397|P2|Participant Flow|Side Batch Then Standard Batch|Linagliptin/metformin FDC tablet from side batch, then Linagliptin/metformin FDC tablet from standard batch
192415|NCT01216397|P1|Participant Flow|Standard Batch Then Side Batch|Linagliptin/metformin FDC tablet from standard batch, then Linagliptin/metformin FDC tablet from side batch
192416|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192417|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192418|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192419|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192420|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192421|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192422|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192423|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192424|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192425|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192426|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192427|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192428|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192429|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192430|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192431|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192432|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192433|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192434|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192435|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192436|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192437|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192438|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192439|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192440|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192441|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192442|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192443|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192444|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192445|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192446|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192447|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192448|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192449|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192450|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192451|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192452|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192453|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192454|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192455|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192456|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192457|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192458|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192459|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192460|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192461|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192462|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192463|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192464|NCT01216397|E2|Reported Event|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192465|NCT01216397|E1|Reported Event|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
192466|NCT01216319|B1|Baseline|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
192467|NCT01216319|P1|Participant Flow|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
192468|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
192469|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
192470|NCT01216319|E1|Reported Event|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
192471|NCT01216241|B3|Baseline|Total|Total of all reporting groups
192472|NCT01216241|B2|Baseline|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
192473|NCT01216241|B1|Baseline|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
192474|NCT01216241|P2|Participant Flow|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
192475|NCT01216241|P1|Participant Flow|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
192476|NCT01216241|O2|Outcome|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
192477|NCT01216241|O1|Outcome|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
192478|NCT01216241|E2|Reported Event|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
192479|NCT01216241|E1|Reported Event|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
192480|NCT01216163|B4|Baseline|Total|Total of all reporting groups
192481|NCT01216163|B3|Baseline|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192482|NCT01216163|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192483|NCT01216163|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192484|NCT01216163|P3|Participant Flow|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192485|NCT01216163|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192486|NCT01216163|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192487|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192488|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192489|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192490|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192491|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192492|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192493|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192494|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192495|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192496|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192497|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192498|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192499|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192500|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192501|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192502|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192503|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192504|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192505|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192506|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192507|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192508|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192509|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192510|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192511|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192512|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192513|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192514|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192515|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192516|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192517|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192518|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192519|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192520|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192521|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192522|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192523|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192524|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192525|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192526|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192527|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192528|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192529|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192530|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192531|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192532|NCT01216163|E3|Reported Event|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
192533|NCT01216163|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
192534|NCT01216163|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
192535|NCT01216072|B3|Baseline|Total|Total of all reporting groups
192536|NCT01216072|B2|Baseline|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192537|NCT01216072|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192538|NCT01216072|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192539|NCT01216072|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192540|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192541|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192542|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192543|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192544|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192545|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192546|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192547|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192548|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192549|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192550|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192551|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192552|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192553|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192554|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192555|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192556|NCT01216072|O3|Outcome|Extension Fingolimod Period|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192557|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
192558|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192559|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192560|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192561|NCT01216072|E3|Reported Event|Fingolimod Extension Phase|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
192562|NCT01216072|E2|Reported Event|Standard MS DMT|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
192563|NCT01216072|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
192564|NCT01215981|B3|Baseline|Total|Total of all reporting groups
192565|NCT01215981|B2|Baseline|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
192566|NCT01215981|B1|Baseline|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
192567|NCT01215981|P2|Participant Flow|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
192568|NCT01215981|P1|Participant Flow|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
192569|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
192570|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
192571|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
192572|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
192573|NCT01215981|E2|Reported Event|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
192574|NCT01215981|E1|Reported Event|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
192575|NCT01215968|B3|Baseline|Total|Total of all reporting groups
192576|NCT01215968|B2|Baseline|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192577|NCT01215968|B1|Baseline|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192578|NCT01215968|P2|Participant Flow|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192579|NCT01215968|P1|Participant Flow|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192580|NCT01215968|O3|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
192581|NCT01215968|O2|Outcome|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192582|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192583|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192584|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192585|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192586|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192587|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192588|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192589|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192590|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192591|NCT01215968|E3|Reported Event|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
192592|NCT01215968|E2|Reported Event|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
192593|NCT01215968|E1|Reported Event|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
192594|NCT01215955|B5|Baseline|Total|Total of all reporting groups
192595|NCT01215955|B4|Baseline|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192596|NCT01215955|B3|Baseline|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
225890|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
192597|NCT01215955|B2|Baseline|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192598|NCT01215955|B1|Baseline|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192599|NCT01215955|P4|Participant Flow|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192600|NCT01215955|P3|Participant Flow|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192601|NCT01215955|P2|Participant Flow|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192602|NCT01215955|P1|Participant Flow|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192603|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192604|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192605|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192606|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192607|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192608|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192609|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192610|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192611|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192799|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192612|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192613|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192614|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192615|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192616|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192617|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192618|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192619|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192620|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192621|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192622|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192623|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192624|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192625|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192626|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192800|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192627|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192628|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192629|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192630|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192631|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192632|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192633|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192634|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192635|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192636|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192637|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192638|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192639|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192640|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192641|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192801|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192642|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192643|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192644|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192645|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192646|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192647|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192648|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192649|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192650|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192651|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192652|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192653|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192654|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192655|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192656|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192802|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192657|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192658|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192659|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192660|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192661|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192662|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192663|NCT01215955|E4|Reported Event|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192664|NCT01215955|E3|Reported Event|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
192665|NCT01215955|E2|Reported Event|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192666|NCT01215955|E1|Reported Event|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
192667|NCT01215929|B3|Baseline|Total|Total of all reporting groups
192668|NCT01215929|B2|Baseline|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
192669|NCT01215929|B1|Baseline|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
192670|NCT01215929|P2|Participant Flow|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
192671|NCT01215929|P1|Participant Flow|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
192672|NCT01215929|O2|Outcome|Placebo|Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
192673|NCT01215929|O1|Outcome|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
192674|NCT01215929|E2|Reported Event|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
192675|NCT01215929|E1|Reported Event|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
192676|NCT01215851|B7|Baseline|Total|Total of all reporting groups
192677|NCT01215851|B6|Baseline|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192678|NCT01215851|B5|Baseline|Rifafour e-275 mg|Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192679|NCT01215851|B4|Baseline|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192680|NCT01215851|B3|Baseline|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192681|NCT01215851|B2|Baseline|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192682|NCT01215851|B1|Baseline|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192683|NCT01215851|P6|Participant Flow|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192684|NCT01215851|P5|Participant Flow|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192685|NCT01215851|P4|Participant Flow|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192686|NCT01215851|P3|Participant Flow|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192687|NCT01215851|P2|Participant Flow|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192688|NCT01215851|P1|Participant Flow|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192689|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192690|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192691|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192692|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192693|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192694|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192695|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192696|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192697|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192698|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192699|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192700|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192701|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192702|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192703|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192704|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192705|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|MC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192706|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192707|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192708|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192709|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192710|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192711|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192712|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192970|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192713|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
192714|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
192715|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
192716|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
192717|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192718|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
192719|NCT01215851|E6|Reported Event|TMC207 and PA-824|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg
192720|NCT01215851|E5|Reported Event|Rifafour e-275 mg|Rifafour e-275 275 mg
192721|NCT01215851|E4|Reported Event|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg
192722|NCT01215851|E3|Reported Event|PA-824 and Pyrazinamide|PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo
192723|NCT01215851|E2|Reported Event|TMC207 and Pyrazinamide|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight)
192724|NCT01215851|E1|Reported Event|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo
192725|NCT01215786|B4|Baseline|Total|Total of all reporting groups
192726|NCT01215786|B3|Baseline|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192727|NCT01215786|B2|Baseline|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192728|NCT01215786|B1|Baseline|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192729|NCT01215786|P3|Participant Flow|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192730|NCT01215786|P2|Participant Flow|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192731|NCT01215786|P1|Participant Flow|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192732|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192733|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192734|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192735|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192736|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192737|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192738|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192739|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192740|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192741|NCT01215786|E3|Reported Event|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
192742|NCT01215786|E2|Reported Event|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
192743|NCT01215786|E1|Reported Event|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
192744|NCT01215734|B3|Baseline|Total|Total of all reporting groups
192745|NCT01215734|B2|Baseline|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
192746|NCT01215734|B1|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
192747|NCT01215734|P2|Participant Flow|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
192748|NCT01215734|P1|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
192749|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
192803|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192750|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
192751|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
192752|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
192753|NCT01215734|E2|Reported Event|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
192754|NCT01215734|E1|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
192755|NCT01215721|B1|Baseline|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
192756|NCT01215721|P1|Participant Flow|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
192757|NCT01215721|O1|Outcome|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
192758|NCT01215721|E1|Reported Event|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
192759|NCT01215643|B6|Baseline|Total|Total of all reporting groups
192760|NCT01215643|B5|Baseline|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192761|NCT01215643|B4|Baseline|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192762|NCT01215643|B3|Baseline|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192763|NCT01215643|B2|Baseline|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192764|NCT01215643|B1|Baseline|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192765|NCT01215643|P5|Participant Flow|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192766|NCT01215643|P4|Participant Flow|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
192767|NCT01215643|P3|Participant Flow|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192768|NCT01215643|P2|Participant Flow|ALV 600 mg+RBV|ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192769|NCT01215643|P1|Participant Flow|ALV 1000 mg|Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
192770|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192771|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192772|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192773|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192774|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192775|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192776|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192777|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192778|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192779|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192780|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192781|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192782|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192783|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192784|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192785|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192786|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192787|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192788|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192789|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192790|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192791|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192792|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192793|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192794|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192795|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192796|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192797|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192798|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
225891|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
192804|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192805|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192806|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192807|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192808|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192809|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192810|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192811|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192812|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192813|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192814|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192815|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192816|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192817|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192818|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192819|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192820|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192821|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192822|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192823|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192824|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192825|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192826|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192827|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192828|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192829|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192830|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192831|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192832|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192833|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192834|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192835|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192836|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192837|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192838|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192839|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192840|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192841|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192842|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192843|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192844|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192845|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192846|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192847|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192848|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192849|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192850|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192851|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192852|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192853|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192854|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192855|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
192856|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192857|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192858|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192859|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192860|NCT01215643|E10|Reported Event|PEG+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
192861|NCT01215643|E9|Reported Event|ALV 600 mg+PEG: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192862|NCT01215643|E8|Reported Event|ALV 800 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192863|NCT01215643|E7|Reported Event|ALV 600 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192864|NCT01215643|E6|Reported Event|ALV 1000 mg: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192865|NCT01215643|E5|Reported Event|PEG+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
192866|NCT01215643|E4|Reported Event|ALV 600 mg+PEG: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
192867|NCT01215643|E3|Reported Event|ALV 800 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
192868|NCT01215643|E2|Reported Event|ALV 600 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
192869|NCT01215643|E1|Reported Event|ALV 1000 mg: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
192870|NCT01215513|B1|Baseline|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
192871|NCT01215513|P1|Participant Flow|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
192872|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
192873|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
192874|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
192875|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
192876|NCT01215513|E1|Reported Event|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
192877|NCT01215435|B3|Baseline|Total|Total of all reporting groups
192878|NCT01215435|B2|Baseline|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192879|NCT01215435|B1|Baseline|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192880|NCT01215435|P2|Participant Flow|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192881|NCT01215435|P1|Participant Flow|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192882|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192883|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192884|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192885|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192920|NCT01215357|P1|Participant Flow|Ecopipam (50 or 100 mg, as Needed)|Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
192886|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192887|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192888|NCT01215435|E2|Reported Event|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192889|NCT01215435|E1|Reported Event|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
192890|NCT01215422|B5|Baseline|Total|Total of all reporting groups
192891|NCT01215422|B4|Baseline|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
192892|NCT01215422|B3|Baseline|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
192893|NCT01215422|B2|Baseline|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
192894|NCT01215422|B1|Baseline|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
192895|NCT01215422|P4|Participant Flow|GS Intubation Participants|Children intubated with the GlideScope system (GS) VLS
192896|NCT01215422|P3|Participant Flow|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS
192897|NCT01215422|P2|Participant Flow|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice.
192898|NCT01215422|P1|Participant Flow|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
192899|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who intubated minimum 18 children with the KS VLS
192900|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who intubated minimum 18 children with the GS VLS.
192901|NCT01215422|O2|Outcome|Randomized to KS First|
192902|NCT01215422|O1|Outcome|Randomized to GS First|
192903|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated with the standard laryngoscope of the anesthesiologist's choice
192904|NCT01215422|O2|Outcome|KS Intubation Participants|Children successfully intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
192905|NCT01215422|O1|Outcome|GS Intubation Participants|Children successfully intubated with the GlideScope system (GS) video laryngoscope (VLS)
192906|NCT01215422|O4|Outcome|KS Intubation Times for Those Who Used GS First|
192907|NCT01215422|O3|Outcome|GS Intubation Times for Those Who Used KS First|
192908|NCT01215422|O2|Outcome|KS Intubation Times for Those Who Used KS First|
192909|NCT01215422|O1|Outcome|GS Intubation Times for Those Who Used GS First|
192910|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
192911|NCT01215422|O2|Outcome|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
192912|NCT01215422|O1|Outcome|GS Intubation Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
192913|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who performed minimum 18 intubations with the KS VLS
192914|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who performed minimum 18 intubations with the GS VLS.
192915|NCT01215422|E4|Reported Event|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
192916|NCT01215422|E3|Reported Event|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
192917|NCT01215422|E2|Reported Event|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
192918|NCT01215422|E1|Reported Event|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
192919|NCT01215357|B1|Baseline|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
192968|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192969|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192921|NCT01215357|O1|Outcome|Ecopipam 50 mg or 100 mg as Needed|Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
192922|NCT01215357|E1|Reported Event|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
192923|NCT01215292|B6|Baseline|Total|Total of all reporting groups
192924|NCT01215292|B5|Baseline|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
192925|NCT01215292|B4|Baseline|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
192926|NCT01215292|B3|Baseline|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
192927|NCT01215292|B2|Baseline|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
192928|NCT01215292|B1|Baseline|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
192929|NCT01215292|P5|Participant Flow|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
192930|NCT01215292|P4|Participant Flow|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
192931|NCT01215292|P3|Participant Flow|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
192932|NCT01215292|P2|Participant Flow|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
192933|NCT01215292|P1|Participant Flow|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
192934|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
192935|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
192936|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
192937|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
192938|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|
192939|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
192940|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days
192941|NCT01215292|O3|Outcome|Acyline & TGel & Ketoconazole 800 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days
192942|NCT01215292|O2|Outcome|Acyline & TGel & Ketoconazole 400 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days
192943|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo
192944|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
192945|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
192946|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
192947|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
192948|NCT01215292|O1|Outcome|Acyline + Testosterone Gel + Placebo|300mcg Acyline, 1% testosterone gel 5g daily + placebo
192949|NCT01215292|E5|Reported Event|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
192950|NCT01215292|E4|Reported Event|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
192951|NCT01215292|E3|Reported Event|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
192952|NCT01215292|E2|Reported Event|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
192953|NCT01215292|E1|Reported Event|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
192954|NCT01215279|B3|Baseline|Total|Total of all reporting groups
192955|NCT01215279|B2|Baseline|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192956|NCT01215279|B1|Baseline|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192957|NCT01215279|P2|Participant Flow|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192958|NCT01215279|P1|Participant Flow|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192959|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192960|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192961|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192962|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192963|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192964|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192965|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192966|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192967|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192971|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192972|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192973|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192974|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192975|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192976|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192977|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192978|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192979|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192980|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192981|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192982|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192983|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192984|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192985|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192986|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192987|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192988|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192989|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192990|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192991|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192992|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192993|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192994|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192995|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192996|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192997|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
192998|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
192999|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193000|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193001|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193002|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193003|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193004|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193005|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193006|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193007|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193008|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193009|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193010|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193011|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193012|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193013|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193014|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193015|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193016|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193017|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193018|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193019|NCT01215279|E2|Reported Event|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
193020|NCT01215279|E1|Reported Event|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
193021|NCT01215227|B7|Baseline|Total|Total of all reporting groups
193022|NCT01215227|B6|Baseline|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193023|NCT01215227|B5|Baseline|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193024|NCT01215227|B4|Baseline|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193044|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193025|NCT01215227|B3|Baseline|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193026|NCT01215227|B2|Baseline|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193027|NCT01215227|B1|Baseline|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193028|NCT01215227|P6|Participant Flow|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193029|NCT01215227|P5|Participant Flow|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193030|NCT01215227|P4|Participant Flow|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193031|NCT01215227|P3|Participant Flow|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193032|NCT01215227|P2|Participant Flow|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193033|NCT01215227|P1|Participant Flow|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193034|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193035|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193036|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193037|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193038|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193039|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193040|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193041|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193042|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193043|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193095|NCT01215097|O1|Outcome|Placebo|Placebo
193096|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193045|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193046|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193047|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193048|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193049|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193050|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193051|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193052|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193053|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193054|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193055|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193056|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193057|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193058|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193059|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193060|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193061|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193062|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193063|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193097|NCT01215097|O1|Outcome|Placebo|Placebo
193098|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193099|NCT01215097|O1|Outcome|Placebo|Placebo
193064|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193065|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193066|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193067|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193068|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193069|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193070|NCT01215227|E6|Reported Event|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193071|NCT01215227|E5|Reported Event|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
193072|NCT01215227|E4|Reported Event|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193073|NCT01215227|E3|Reported Event|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193074|NCT01215227|E2|Reported Event|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193075|NCT01215227|E1|Reported Event|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
193076|NCT01215123|B1|Baseline|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
193077|NCT01215123|P1|Participant Flow|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
193078|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
193079|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
193080|NCT01215123|E1|Reported Event|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
193081|NCT01215097|B3|Baseline|Total|Total of all reporting groups
193082|NCT01215097|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193083|NCT01215097|B1|Baseline|Placebo|Placebo
193084|NCT01215097|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193085|NCT01215097|P1|Participant Flow|Placebo|Placebo
193086|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193087|NCT01215097|O1|Outcome|Placebo|Placebo
193088|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193089|NCT01215097|O1|Outcome|Placebo|Placebo
193090|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193091|NCT01215097|O1|Outcome|Placebo|Placebo
193092|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193093|NCT01215097|O1|Outcome|Placebo|Placebo
193094|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193100|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193101|NCT01215097|O1|Outcome|Placebo|Placebo
193102|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193103|NCT01215097|O1|Outcome|Placebo|Placebo
193104|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193105|NCT01215097|O1|Outcome|Placebo|Placebo
193106|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193107|NCT01215097|O1|Outcome|Placebo|Placebo
193108|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193109|NCT01215097|O1|Outcome|Placebo|Placebo
193110|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193111|NCT01215097|O1|Outcome|Placebo|Placebo
193112|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193113|NCT01215097|O1|Outcome|Placebo|Placebo
193114|NCT01215097|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193115|NCT01215097|E1|Reported Event|Placebo|Placebo
193116|NCT01214980|B3|Baseline|Total|Total of all reporting groups
193117|NCT01214980|B2|Baseline|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193118|NCT01214980|B1|Baseline|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193119|NCT01214980|P2|Participant Flow|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193120|NCT01214980|P1|Participant Flow|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193121|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193122|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193123|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193124|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193125|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193126|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193127|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193128|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193129|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
193130|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193131|NCT01214980|E2|Reported Event|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
225892|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
193132|NCT01214980|E1|Reported Event|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
193133|NCT01214915|B1|Baseline|Anagrelide Hydrochloride|
193134|NCT01214915|P1|Participant Flow|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193135|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193136|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193137|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193138|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193139|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
193140|NCT01214915|E1|Reported Event|Anagrelide Hydrochloride|
193141|NCT01214850|B4|Baseline|Total|Total of all reporting groups
193142|NCT01214850|B3|Baseline|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193143|NCT01214850|B2|Baseline|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193144|NCT01214850|B1|Baseline|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193145|NCT01214850|P3|Participant Flow|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193146|NCT01214850|P2|Participant Flow|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193147|NCT01214850|P1|Participant Flow|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193148|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193149|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193150|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193151|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
193152|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193153|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
193154|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193155|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193156|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193157|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193158|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193159|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193160|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193161|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193162|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193163|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193164|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193165|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193166|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193167|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193168|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193169|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193170|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193171|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193172|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193173|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193174|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193175|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193176|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193177|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193178|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193179|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193180|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193181|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193182|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193183|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193184|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193185|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193186|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193187|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193188|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193189|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193190|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193191|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193192|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193193|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193194|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193195|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193196|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193197|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193198|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193199|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193200|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193201|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193202|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193203|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193204|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193205|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193206|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193207|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193208|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
193209|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193210|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193211|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193212|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193213|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193214|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193215|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193216|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193217|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193218|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193219|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193220|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193221|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193222|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193223|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193224|NCT01214850|E3|Reported Event|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
193390|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193225|NCT01214850|E2|Reported Event|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
193226|NCT01214850|E1|Reported Event|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
193227|NCT01214837|B4|Baseline|Total|Total of all reporting groups
193228|NCT01214837|B3|Baseline|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193229|NCT01214837|B2|Baseline|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193230|NCT01214837|B1|Baseline|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193231|NCT01214837|P3|Participant Flow|Routine Vaccines|Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
193232|NCT01214837|P2|Participant Flow|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193233|NCT01214837|P1|Participant Flow|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193234|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193235|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193236|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193237|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193238|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193239|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193240|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193241|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193242|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193243|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193244|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193245|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193246|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193247|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193248|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193249|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193250|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193251|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193252|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193253|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193254|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193255|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193256|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193257|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193258|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193259|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193260|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193261|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193262|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193263|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193264|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193265|NCT01214837|O1|Outcome|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193266|NCT01214837|E3|Reported Event|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
193267|NCT01214837|E2|Reported Event|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
193268|NCT01214837|E1|Reported Event|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
193269|NCT01214824|B1|Baseline|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
193270|NCT01214824|P1|Participant Flow|Intervention Group|Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
193271|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
193272|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
193273|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System intermittently
193274|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
193275|NCT01214824|E1|Reported Event|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
193276|NCT01214811|B1|Baseline|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
193277|NCT01214811|P1|Participant Flow|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
193278|NCT01214811|O1|Outcome|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
193279|NCT01214811|E1|Reported Event|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
193280|NCT01214759|B1|Baseline|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193281|NCT01214759|P1|Participant Flow|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193282|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193283|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193284|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193285|NCT01214759|E1|Reported Event|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
193286|NCT01214720|B3|Baseline|Total|Total of all reporting groups
193287|NCT01214720|B2|Baseline|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193288|NCT01214720|B1|Baseline|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193289|NCT01214720|P2|Participant Flow|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193323|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193391|NCT01214239|O1|Outcome|Placebo|Placebo
193290|NCT01214720|P1|Participant Flow|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193291|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193292|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193293|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193294|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193295|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193296|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193297|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193298|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193299|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193300|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193382|NCT01214239|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193301|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193302|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193303|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193304|NCT01214720|E2|Reported Event|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193305|NCT01214720|E1|Reported Event|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
193306|NCT01214616|B5|Baseline|Total|Total of all reporting groups
193307|NCT01214616|B4|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193308|NCT01214616|B3|Baseline|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193309|NCT01214616|B2|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193310|NCT01214616|B1|Baseline|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193311|NCT01214616|P4|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193312|NCT01214616|P3|Participant Flow|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193313|NCT01214616|P2|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193314|NCT01214616|P1|Participant Flow|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193315|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193316|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193317|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193318|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193319|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193320|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193321|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193322|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193383|NCT01214239|B1|Baseline|Placebo|Placebo
193384|NCT01214239|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193385|NCT01214239|P1|Participant Flow|Placebo|Placebo
193386|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193324|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193325|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193326|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193327|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193328|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193329|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193330|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
193331|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193332|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193333|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193334|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193335|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193336|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193337|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193387|NCT01214239|O1|Outcome|Placebo|Placebo
193388|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193389|NCT01214239|O1|Outcome|Placebo|Placebo
193338|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
193339|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193340|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193341|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193342|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193343|NCT01214616|E4|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
193344|NCT01214616|E3|Reported Event|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
193345|NCT01214616|E2|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193346|NCT01214616|E1|Reported Event|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
193347|NCT01214434|B3|Baseline|Total|Total of all reporting groups
193348|NCT01214434|B2|Baseline|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193349|NCT01214434|B1|Baseline|Bland Emollient|Bland emollient : Eucerin cream twice daily
193350|NCT01214434|P2|Participant Flow|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193351|NCT01214434|P1|Participant Flow|Bland Emollient|Bland emollient : Eucerin cream twice daily
193352|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193353|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193354|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193355|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193356|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193357|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193358|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193359|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193360|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193361|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193362|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193363|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
193364|NCT01214434|E2|Reported Event|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
193365|NCT01214434|E1|Reported Event|Bland Emollient|Bland emollient : Eucerin cream twice daily
193366|NCT01214395|B1|Baseline|Tea Tree Oil Application|tea tree oil medication group
193367|NCT01214395|P1|Participant Flow|Tea Tree Oil Application|tea tree oil medication group
193368|NCT01214395|O1|Outcome|Did Not Have Staph. Aureus Infection|No exit site infection or peritonitis with Staph. aureus
193369|NCT01214395|O1|Outcome|Tea Tree Oil|tea tree oil application
193370|NCT01214395|E1|Reported Event|Tea Tree Oil Application|tea tree oil medication group
193371|NCT01214330|B1|Baseline|Solopap|females, age >18, without severe hand arthritis
193372|NCT01214330|P1|Participant Flow|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
193373|NCT01214330|O1|Outcome|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
193374|NCT01214330|E1|Reported Event|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
193375|NCT01214252|B1|Baseline|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
193376|NCT01214252|P1|Participant Flow|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
193377|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
193378|NCT01214252|O1|Outcome|Permacol Patients|"Total (confirmed or unconfrimed) hernia or hernia recurrence at the repair site by year (# and percentage).~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms questionnaire but not confirmed by clinical assessment by a surgeon or medical chart review"
193379|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
193380|NCT01214252|E1|Reported Event|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
193381|NCT01214239|B3|Baseline|Total|Total of all reporting groups
193392|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193393|NCT01214239|O1|Outcome|Placebo|Placebo
193394|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193395|NCT01214239|O1|Outcome|Placebo|Placebo
193396|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193397|NCT01214239|O1|Outcome|Placebo|Placebo
193398|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193399|NCT01214239|O1|Outcome|Placebo|Placebo
193400|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193401|NCT01214239|O1|Outcome|Placebo|Placebo
193402|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193403|NCT01214239|O1|Outcome|Placebo|Placebo
193404|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193405|NCT01214239|O1|Outcome|Placebo|Placebo
193406|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193407|NCT01214239|O1|Outcome|Placebo|Placebo
193408|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193409|NCT01214239|O1|Outcome|Placebo|Placebo
193410|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193411|NCT01214239|O1|Outcome|Placebo|Placebo
193412|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193413|NCT01214239|O1|Outcome|Placebo|Placebo
193414|NCT01214239|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
193415|NCT01214239|E1|Reported Event|Placebo|Placebo
193416|NCT01214174|B4|Baseline|Total|Total of all reporting groups
193417|NCT01214174|B3|Baseline|Dose 3|IBI-10090 1046ug
193418|NCT01214174|B2|Baseline|Dose 2|IBI-10090 776ug
193419|NCT01214174|B1|Baseline|Dose 1|IBI-10090 513ug
193420|NCT01214174|P3|Participant Flow|Dose 3|IBI-10090 1046ug
193421|NCT01214174|P2|Participant Flow|Dose 2|IBI-10090 776ug
193422|NCT01214174|P1|Participant Flow|Dose 1|IBI-10090 513ug
193423|NCT01214174|O3|Outcome|Dose 3|IBI-10090 1046ug
193424|NCT01214174|O2|Outcome|Dose 2|IBI-10090 776ug
193425|NCT01214174|O1|Outcome|Dose 1|IBI-10090 513ug
193426|NCT01214174|E3|Reported Event|Dose 3|IBI-10090 1046ug
193427|NCT01214174|E2|Reported Event|Dose 2|IBI-10090 776ug
193428|NCT01214174|E1|Reported Event|Dose 1|IBI-10090 513ug
193429|NCT01214161|B3|Baseline|Total|Total of all reporting groups
193430|NCT01214161|B2|Baseline|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193431|NCT01214161|B1|Baseline|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193432|NCT01214161|P2|Participant Flow|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193433|NCT01214161|P1|Participant Flow|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193434|NCT01214161|O2|Outcome|Providers|The healthcare provider placing the IUD on that particular participant.
193435|NCT01214161|O1|Outcome|Participants|The cohort of all 200 women having their IUD inserted.
193458|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193459|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193460|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193461|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193462|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193436|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193437|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193438|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193439|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193440|NCT01214161|E2|Reported Event|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193441|NCT01214161|E1|Reported Event|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
193442|NCT01214109|B1|Baseline|All Subjects|24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
193443|NCT01214109|P4|Participant Flow|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193444|NCT01214109|P3|Participant Flow|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193445|NCT01214109|P2|Participant Flow|0.125 mg t.i.d. Immediate Release (IR)|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193446|NCT01214109|P1|Participant Flow|0.375 mg q.d.Extended Release (ER)|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193447|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193448|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193449|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193450|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193451|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193452|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193453|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193454|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193455|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193456|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193457|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193562|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
193463|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193464|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193465|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193466|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193467|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193468|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193469|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193470|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193471|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193472|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193473|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193474|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193475|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193476|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193477|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193478|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193479|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193480|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193481|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193482|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193483|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193484|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193485|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193486|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193487|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193488|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193489|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193490|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193491|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193492|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193493|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193494|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193495|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193496|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193497|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193498|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193499|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193500|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193501|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193502|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193503|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193504|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193505|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193506|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193507|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193508|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193509|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193510|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193511|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193512|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193513|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193514|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193515|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
225893|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
193516|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193517|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193518|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193519|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193520|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193521|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193522|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193523|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193524|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193525|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193526|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193527|NCT01214109|E7|Reported Event|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193528|NCT01214109|E6|Reported Event|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
193529|NCT01214109|E5|Reported Event|0.375 mg q.d.ER Down-titration|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193530|NCT01214109|E4|Reported Event|0.75 mg q.d. ER Down-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193531|NCT01214109|E3|Reported Event|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193532|NCT01214109|E2|Reported Event|0.75 mg q.d. ER Up-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193533|NCT01214109|E1|Reported Event|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
193534|NCT01213966|B5|Baseline|Total|Total of all reporting groups
193535|NCT01213966|B4|Baseline|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
193536|NCT01213966|B3|Baseline|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
193537|NCT01213966|B2|Baseline|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
193538|NCT01213966|B1|Baseline|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
193539|NCT01213966|P4|Participant Flow|1200 mg OZ439 po Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
193540|NCT01213966|P3|Participant Flow|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
193541|NCT01213966|P2|Participant Flow|400 mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
193542|NCT01213966|P1|Participant Flow|800 mg OZ439 po Single Dose|Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
193543|NCT01213966|O4|Outcome|1200 mg OZ439 po Single Dose|"Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.~It was decided not to proceed with a fifth cohort and no further patients were enrolled."
193544|NCT01213966|O3|Outcome|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
193545|NCT01213966|O2|Outcome|400 mg OZ439 p.o. Single Dose|After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
193546|NCT01213966|O1|Outcome|800 mg OZ439 po Single Dose|The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
193547|NCT01213966|E4|Reported Event|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
193548|NCT01213966|E3|Reported Event|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
193549|NCT01213966|E2|Reported Event|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
193550|NCT01213966|E1|Reported Event|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
193551|NCT01213836|B3|Baseline|Total|Total of all reporting groups
193552|NCT01213836|B2|Baseline|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
193553|NCT01213836|B1|Baseline|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
193554|NCT01213836|P2|Participant Flow|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
193555|NCT01213836|P1|Participant Flow|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
193556|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
193557|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193558|NCT01213836|O2|Outcome|Seroquel IR|Patients treated with at least one dose of Seroquel IR
193559|NCT01213836|O1|Outcome|Seroquel XR|Patients treated with at least one dose of Seroquel XR
193560|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
193561|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193563|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193564|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
193565|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193566|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
193567|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193568|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193569|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
193570|NCT01213836|E2|Reported Event|Seroquel IR|Patients treated with at least one dose of Seroquel IR
193571|NCT01213836|E1|Reported Event|Seroquel XR|Patients treated with at least one dose of Seroquel XR
193572|NCT01213823|B3|Baseline|Total|Total of all reporting groups
193573|NCT01213823|B2|Baseline|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
193574|NCT01213823|B1|Baseline|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
193575|NCT01213823|P2|Participant Flow|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
193576|NCT01213823|P1|Participant Flow|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
193577|NCT01213823|O2|Outcome|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
193578|NCT01213823|O1|Outcome|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
193579|NCT01213823|E2|Reported Event|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
193580|NCT01213823|E1|Reported Event|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
193581|NCT01213706|B1|Baseline|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
193582|NCT01213706|P1|Participant Flow|SHAM WBPA Then WBPA|
193583|NCT01213706|O2|Outcome|Sham WBPA|Subjects will be resting on the platform without any WBPA.
193584|NCT01213706|O1|Outcome|WBPA|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
193585|NCT01213706|E2|Reported Event|Sham WBPA|"The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.~Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge."
193612|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193838|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193586|NCT01213706|E1|Reported Event|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
193587|NCT01213589|B4|Baseline|Total|Total of all reporting groups
193588|NCT01213589|B3|Baseline|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193589|NCT01213589|B2|Baseline|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193590|NCT01213589|B1|Baseline|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193591|NCT01213589|P3|Participant Flow|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193592|NCT01213589|P2|Participant Flow|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193593|NCT01213589|P1|Participant Flow|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193594|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193595|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193596|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193597|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193598|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193599|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193600|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193601|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193602|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193603|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193604|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193605|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193606|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193607|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193608|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193609|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193610|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193611|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193613|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193614|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193615|NCT01213589|E3|Reported Event|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
193616|NCT01213589|E2|Reported Event|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
193617|NCT01213589|E1|Reported Event|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
193618|NCT01213576|B5|Baseline|Total|Total of all reporting groups
193619|NCT01213576|B4|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual|Albendazole 800mg and ivermectin 400mcg/kg given twice a year
193620|NCT01213576|B3|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Biannual|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
193621|NCT01213576|B2|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Annual|Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
193622|NCT01213576|B1|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Annual|Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
193623|NCT01213576|P4|Participant Flow|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
193624|NCT01213576|P3|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
193625|NCT01213576|P2|Participant Flow|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
193626|NCT01213576|P1|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
193627|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
193628|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
193629|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
193630|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
193631|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
193632|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
193633|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
193634|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
193635|NCT01213576|E4|Reported Event|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
193636|NCT01213576|E3|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
193637|NCT01213576|E2|Reported Event|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
193638|NCT01213576|E1|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
193639|NCT01213329|B3|Baseline|Total|Total of all reporting groups
193640|NCT01213329|B2|Baseline|Donor Comparison|
193641|NCT01213329|B1|Baseline|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
193642|NCT01213329|P2|Participant Flow|Donor Comparison|
193643|NCT01213329|P1|Participant Flow|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
193644|NCT01213329|O2|Outcome|Donor Comparison|
193645|NCT01213329|O1|Outcome|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
193646|NCT01213329|E2|Reported Event|Donor Comparison|
193647|NCT01213329|E1|Reported Event|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
193648|NCT01213316|B1|Baseline|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193649|NCT01213316|P1|Participant Flow|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193650|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193686|NCT01213251|B4|Baseline|Total|Total of all reporting groups
193651|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193652|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193653|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193654|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193655|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193656|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
193657|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
193658|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
193659|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193660|NCT01213316|O1|Outcome|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193661|NCT01213316|E3|Reported Event|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193662|NCT01213316|E2|Reported Event|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193663|NCT01213316|E1|Reported Event|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
193664|NCT01213264|B4|Baseline|Total|Total of all reporting groups
193665|NCT01213264|B3|Baseline|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193666|NCT01213264|B2|Baseline|Sugammadex|Participants administered sugammadex for NMB reversal
193667|NCT01213264|B1|Baseline|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
193668|NCT01213264|P3|Participant Flow|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193669|NCT01213264|P2|Participant Flow|Sugammadex|Participants administered sugammadex for NMB reversal
193670|NCT01213264|P1|Participant Flow|Spontaneous Reversal|Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
193671|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
193672|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193673|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
193674|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193675|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
193676|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
193677|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193678|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
193679|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
193680|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193681|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
193682|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
193683|NCT01213264|E3|Reported Event|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
193684|NCT01213264|E2|Reported Event|Sugammadex|Participants administered sugammadex for NMB reversal
193685|NCT01213264|E1|Reported Event|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
193687|NCT01213251|B3|Baseline|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
193688|NCT01213251|B2|Baseline|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
193689|NCT01213251|B1|Baseline|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
193690|NCT01213251|P3|Participant Flow|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
193691|NCT01213251|P2|Participant Flow|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
193692|NCT01213251|P1|Participant Flow|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
193693|NCT01213251|O1|Outcome|All Subjects|All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
193694|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193695|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
193696|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193697|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
193698|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193699|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
193700|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193701|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
193702|NCT01213251|O3|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193703|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
193704|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
193705|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
193706|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
193707|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
193708|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
193709|NCT01213251|E3|Reported Event|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
193710|NCT01213251|E2|Reported Event|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
193711|NCT01213251|E1|Reported Event|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
193712|NCT01213199|B1|Baseline|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
193713|NCT01213199|P1|Participant Flow|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
193714|NCT01213199|O1|Outcome|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
193715|NCT01213199|E1|Reported Event|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
193716|NCT01213173|B3|Baseline|Total|Total of all reporting groups
193717|NCT01213173|B2|Baseline|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193718|NCT01213173|B1|Baseline|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193719|NCT01213173|P2|Participant Flow|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193720|NCT01213173|P1|Participant Flow|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193721|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193722|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193798|NCT01212991|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193799|NCT01212874|B3|Baseline|Total|Total of all reporting groups
225894|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
193723|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193724|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193725|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193726|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193727|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193728|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193729|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193730|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193731|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193732|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193733|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193734|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193735|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193736|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193737|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193738|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193739|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193740|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193741|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193742|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193743|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193837|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193744|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193745|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193746|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193747|NCT01213173|E2|Reported Event|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
193748|NCT01213173|E1|Reported Event|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
193749|NCT01213043|B3|Baseline|Total|Total of all reporting groups
193750|NCT01213043|B2|Baseline|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
193751|NCT01213043|B1|Baseline|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
193752|NCT01213043|P2|Participant Flow|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
193753|NCT01213043|P1|Participant Flow|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
193754|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193755|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193756|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193757|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193758|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193759|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193760|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193761|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193762|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193763|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193764|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193765|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193766|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193767|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193768|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193769|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193770|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193771|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193772|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193773|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193774|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
193775|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
193776|NCT01213043|E2|Reported Event|120 mg/kg Prolastin-C|
193777|NCT01213043|E1|Reported Event|60 mg/kg Prolastin-C|
193778|NCT01212991|B3|Baseline|Total|Total of all reporting groups
193779|NCT01212991|B2|Baseline|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193780|NCT01212991|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193781|NCT01212991|P2|Participant Flow|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193782|NCT01212991|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193783|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193784|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193785|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193786|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193787|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193788|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193789|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193790|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193791|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193792|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193793|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193794|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193795|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
193796|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
193797|NCT01212991|E2|Reported Event|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
225895|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
193800|NCT01212874|B2|Baseline|Esmolol|"esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension."
193801|NCT01212874|B1|Baseline|Nitroglycerin|"nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery."
193802|NCT01212874|P2|Participant Flow|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
193803|NCT01212874|P1|Participant Flow|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
193804|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
193805|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
193806|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
193807|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
193808|NCT01212874|E2|Reported Event|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
193809|NCT01212874|E1|Reported Event|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
193810|NCT01212770|B4|Baseline|Total|Total of all reporting groups
193811|NCT01212770|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193812|NCT01212770|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193813|NCT01212770|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193814|NCT01212770|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
193815|NCT01212770|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
193816|NCT01212770|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
193817|NCT01212770|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
193818|NCT01212770|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
193819|NCT01212770|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
193820|NCT01212770|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
193821|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193822|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193823|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193824|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193825|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193826|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193827|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193828|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193829|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193830|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193831|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193832|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193833|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193834|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193835|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193836|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193839|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193840|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193841|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193842|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193843|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193844|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193845|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193846|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193847|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193848|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193849|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193850|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193851|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193852|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193853|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193854|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193855|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193856|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193857|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193858|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193859|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193860|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193861|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193862|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193863|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193864|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193865|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193866|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193867|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193868|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193869|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193870|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193871|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193872|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193873|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193874|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193875|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193876|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193877|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193878|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193879|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193880|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193881|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193882|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193883|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193884|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193885|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193886|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193887|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193888|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193889|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193890|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193891|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
193892|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
193893|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193894|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193895|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193896|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193897|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193898|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193899|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193900|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193901|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193902|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193903|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193904|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193905|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193906|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193907|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193908|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193909|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193910|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193911|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193912|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193913|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193914|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193915|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193916|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193917|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193918|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193919|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193920|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193921|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193922|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193923|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193924|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193925|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193926|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193927|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193928|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193929|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193930|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193931|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193932|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193933|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193934|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193935|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193936|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193937|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193938|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193939|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193940|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193941|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193942|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193943|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193944|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193945|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193946|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193947|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193948|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193949|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193950|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193951|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193952|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193953|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193954|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193955|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193956|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193957|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193958|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193959|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193960|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193961|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
193962|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193963|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193964|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193965|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193966|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193967|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193968|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193969|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193970|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193971|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193972|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193973|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193974|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193975|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193976|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193977|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193978|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193979|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193980|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193981|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193982|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193983|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193984|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193985|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193986|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193987|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193988|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193989|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193990|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193991|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193992|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193993|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193994|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193995|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193996|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
193997|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
193998|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
193999|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194000|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194001|NCT01212770|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
194002|NCT01212770|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
194003|NCT01212770|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
194004|NCT01212770|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
194005|NCT01212770|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
194006|NCT01212757|B4|Baseline|Total|Total of all reporting groups
194007|NCT01212757|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194008|NCT01212757|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194009|NCT01212757|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194010|NCT01212757|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
194011|NCT01212757|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
194012|NCT01212757|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
194052|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194013|NCT01212757|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
194014|NCT01212757|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
194015|NCT01212757|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
194016|NCT01212757|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
194017|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194018|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194019|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194020|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194021|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194022|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194023|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194024|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194025|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194026|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194027|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194028|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194029|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194030|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194031|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194032|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194033|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194034|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194035|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194036|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194037|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194038|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194039|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194040|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194041|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194042|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194043|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194044|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194045|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194046|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194047|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194048|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194049|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194050|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194051|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194865|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194053|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194054|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194055|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194056|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194057|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194058|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194059|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194060|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194061|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194062|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194063|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194064|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194065|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194066|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194067|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194068|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194069|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194070|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194071|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194072|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194073|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194074|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194075|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194076|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194077|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194078|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194079|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194080|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194081|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194082|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194083|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
194084|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
194085|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194086|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194087|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194088|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194089|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194090|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194091|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194092|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194093|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194094|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
225896|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
194095|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194096|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194097|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194098|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194099|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194100|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194101|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194102|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194103|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194104|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194105|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194106|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194107|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194108|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194109|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194110|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194111|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194112|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194113|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194114|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194115|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194116|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194117|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194118|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194119|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194120|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194121|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194122|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194123|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194124|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194125|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194126|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194127|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194128|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194129|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194130|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194131|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194132|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194133|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194134|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194135|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194136|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194137|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194866|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194138|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194139|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194140|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194141|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194142|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194143|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194144|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194145|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194146|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194147|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194148|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194149|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194150|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194151|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194152|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194153|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194154|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194155|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194156|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194157|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194158|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194159|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194160|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194161|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194162|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194163|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194164|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194165|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194166|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194167|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194168|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194169|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194170|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194171|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194172|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194173|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194174|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194175|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194176|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194177|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194178|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194179|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194180|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
194181|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194182|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194183|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194184|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
194185|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
194186|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
194187|NCT01212757|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
194188|NCT01212757|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
194189|NCT01212757|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
194190|NCT01212757|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
194191|NCT01212757|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
194192|NCT01212627|B1|Baseline|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
194193|NCT01212627|P1|Participant Flow|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
194194|NCT01212627|O1|Outcome|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
194195|NCT01212627|E1|Reported Event|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
194196|NCT01212484|B1|Baseline|All Study Subjects|
194197|NCT01212484|P2|Participant Flow|Carbidopa (First), Placebo (Second)|Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.
194198|NCT01212484|P1|Participant Flow|Placebo (First), Carbidopa (Second)|Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).
194199|NCT01212484|O2|Outcome|Placebo|
194200|NCT01212484|O1|Outcome|Carbidopa|
194201|NCT01212484|O2|Outcome|Placebo|
194202|NCT01212484|O1|Outcome|Carbidopa|
194203|NCT01212484|O2|Outcome|Placebo|
194204|NCT01212484|O1|Outcome|Carbidopa|
194205|NCT01212484|E2|Reported Event|Placebo|"Placebo~Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
194206|NCT01212484|E1|Reported Event|Carbidopa|"carbidopa~Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
194207|NCT01212445|B4|Baseline|Total|Total of all reporting groups
194208|NCT01212445|B3|Baseline|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194209|NCT01212445|B2|Baseline|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194210|NCT01212445|B1|Baseline|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194211|NCT01212445|P3|Participant Flow|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194212|NCT01212445|P2|Participant Flow|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194213|NCT01212445|P1|Participant Flow|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194214|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194215|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194216|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194217|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194867|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194218|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194219|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194220|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194221|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194222|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194223|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194224|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194225|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194226|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194227|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194228|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194229|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194230|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194231|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194232|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194233|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194234|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
194235|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194236|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194237|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194238|NCT01212445|E3|Reported Event|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194239|NCT01212445|E2|Reported Event|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194240|NCT01212445|E1|Reported Event|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
194241|NCT01212302|B1|Baseline|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
194242|NCT01212302|P1|Participant Flow|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
194243|NCT01212302|O1|Outcome|Clopidogrel Low Response|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
194244|NCT01212302|E1|Reported Event|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
194245|NCT01212185|B3|Baseline|Total|Total of all reporting groups
194246|NCT01212185|B2|Baseline|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
194247|NCT01212185|B1|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
194248|NCT01212185|P2|Participant Flow|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
194249|NCT01212185|P1|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days"
194250|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
194251|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
194252|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
194253|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
194254|NCT01212185|E2|Reported Event|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
194255|NCT01212185|E1|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
194256|NCT01212172|B1|Baseline|Side-by Side Comparsion of Soprano/SHR to Light Sheer|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.~LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
194257|NCT01212172|P2|Participant Flow|LightSheer Duet 810 nm Diode Laser|"Soprano and LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
194258|NCT01212172|P1|Participant Flow|Soprano Duet 810 nm Diode Laser|"Soprano Duet 810 nm diode laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
194259|NCT01212172|O2|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
194260|NCT01212172|O1|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
194261|NCT01212172|O2|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
194262|NCT01212172|O1|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
194263|NCT01212172|E2|Reported Event|Light Sheer 810 nm Diode Laser|"Light Sheer 810 nm Diode Laser~Left Axilla or Lower Leg~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
194264|NCT01212172|E1|Reported Event|Soprano/SHR 810 nm Diode Laser|"Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers~Right Axilla or Lower Leg~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
194265|NCT01212159|B3|Baseline|Total|Total of all reporting groups
194266|NCT01212159|B2|Baseline|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194267|NCT01212159|B1|Baseline|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194268|NCT01212159|P2|Participant Flow|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194269|NCT01212159|P1|Participant Flow|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194270|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194271|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194272|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194273|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194274|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194275|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194276|NCT01212159|E2|Reported Event|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
194277|NCT01212159|E1|Reported Event|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
194278|NCT01212094|B4|Baseline|Total|Total of all reporting groups
194279|NCT01212094|B3|Baseline|Baseline|Patients in their first year baseline prior to treatment phase
194280|NCT01212094|B2|Baseline|Rituximab|Group administered active drug
194281|NCT01212094|B1|Baseline|Placebo|Group administered placebo
194282|NCT01212094|P3|Participant Flow|Rituximab|Group administered active drug
194283|NCT01212094|P2|Participant Flow|Placebo|Group administered placebo
194284|NCT01212094|P1|Participant Flow|Baseline|Patients in their first year baseline prior to study drug phase
194285|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194286|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194287|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194288|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194289|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194290|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194291|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194292|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194293|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194294|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194295|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194296|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194297|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194298|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194299|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194300|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194301|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194302|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194303|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194304|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194305|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194306|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194307|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194308|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194309|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
194310|NCT01212094|O1|Outcome|Placebo|Group administered placebo
194311|NCT01212094|E3|Reported Event|Baseline|Patients in their first year baseline prior to study drug phase
194312|NCT01212094|E2|Reported Event|Rituximab|Group who got active drug
194313|NCT01212094|E1|Reported Event|Placebo|Placebo group
194314|NCT01211873|B4|Baseline|Total|Total of all reporting groups
194315|NCT01211873|B3|Baseline|Dotarem 2 (Gadoterate Meglumine )|All children were assigned to Dotarem
194316|NCT01211873|B2|Baseline|Dotarem (Gadoterate Meglumine )|adults received Dotarem as 2:1 ratio compared to Magnevist.
194317|NCT01211873|B1|Baseline|Magnevist (Gadopentetate Dimeglumine)|adults received Magnevist as 1:2 ratio compared to Dotarem
194318|NCT01211873|P3|Participant Flow|Dotarem 2 (Gadoterate Meglumine )|Pediatric patients were assigned to Dotarem group only
194319|NCT01211873|P2|Participant Flow|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
194320|NCT01211873|P1|Participant Flow|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
194321|NCT01211873|O2|Outcome|Dotarem (Gadoterate Meglumine ) PAIRED|all sequences pre and post injection wil be pooled as PAIRED
194322|NCT01211873|O1|Outcome|Dotarem (Gadoterate Meglumine ) PRE|any sequence acquired prior to injection will be pooled as PRE
194323|NCT01211873|E3|Reported Event|Dotarem 2 (Gadoterate Meglumine )|children were only assigned to Dotarem
194324|NCT01211873|E2|Reported Event|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
194325|NCT01211873|E1|Reported Event|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adults
194326|NCT01211769|B5|Baseline|Total|Total of all reporting groups
194327|NCT01211769|B4|Baseline|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194328|NCT01211769|B3|Baseline|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194329|NCT01211769|B2|Baseline|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194330|NCT01211769|B1|Baseline|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194331|NCT01211769|P4|Participant Flow|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194332|NCT01211769|P3|Participant Flow|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194333|NCT01211769|P2|Participant Flow|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194334|NCT01211769|P1|Participant Flow|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194335|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194336|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194337|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194338|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194339|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194340|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194341|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194342|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194343|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194344|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194345|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194346|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194347|NCT01211769|E4|Reported Event|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
194348|NCT01211769|E3|Reported Event|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
194349|NCT01211769|E2|Reported Event|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194350|NCT01211769|E1|Reported Event|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
194351|NCT01211730|B3|Baseline|Total|Total of all reporting groups
194352|NCT01211730|B2|Baseline|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194353|NCT01211730|B1|Baseline|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194463|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194354|NCT01211730|P2|Participant Flow|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194355|NCT01211730|P1|Participant Flow|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194356|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194357|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194358|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194359|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194360|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194361|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194362|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194363|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194364|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194365|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194366|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194367|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194368|NCT01211730|E2|Reported Event|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194369|NCT01211730|E1|Reported Event|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
194370|NCT01211665|B3|Baseline|Total|Total of all reporting groups
194371|NCT01211665|B2|Baseline|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194372|NCT01211665|B1|Baseline|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194373|NCT01211665|P2|Participant Flow|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194374|NCT01211665|P1|Participant Flow|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194375|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194376|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194377|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194378|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194379|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194380|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
225897|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
194381|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194382|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194383|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194384|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194385|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194386|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194387|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194388|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194389|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194390|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194391|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194392|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194393|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194394|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194395|NCT01211665|E2|Reported Event|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
194396|NCT01211665|E1|Reported Event|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
194397|NCT01211613|B4|Baseline|Total|Total of all reporting groups
194398|NCT01211613|B3|Baseline|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
194399|NCT01211613|B2|Baseline|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
194400|NCT01211613|B1|Baseline|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
194401|NCT01211613|P3|Participant Flow|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
194402|NCT01211613|P2|Participant Flow|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
194464|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194403|NCT01211613|P1|Participant Flow|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
194404|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
194405|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
194406|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
194407|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
194408|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
194409|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
194410|NCT01211613|E3|Reported Event|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
194411|NCT01211613|E2|Reported Event|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
194412|NCT01211613|E1|Reported Event|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
194413|NCT01211535|B3|Baseline|Total|Total of all reporting groups
194414|NCT01211535|B2|Baseline|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194415|NCT01211535|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194416|NCT01211535|P2|Participant Flow|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194417|NCT01211535|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194418|NCT01211535|O2|Outcome|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194419|NCT01211535|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194420|NCT01211535|E2|Reported Event|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194421|NCT01211535|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
194422|NCT01211197|B1|Baseline|Study Overall|"An open label, randomised, three-way crossover study. The three treatments administered were~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~A washout period of at least 7 days was respected between drug administrations."
194423|NCT01211197|P6|Participant Flow|FDC Fed / Individual Tablets Fasted / FDC Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
194424|NCT01211197|P5|Participant Flow|FDC Fed / FDC Fasted / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
194465|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194425|NCT01211197|P4|Participant Flow|Individual Tablets Fasted / FDC Fed / FDC Fasted|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
194426|NCT01211197|P3|Participant Flow|Individual Tablets Fasted / FDC Fasted / FDC Fed|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
194427|NCT01211197|P2|Participant Flow|FDC Fasted / FDC Fed / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
194428|NCT01211197|P1|Participant Flow|FDC Fasted / Individual Tablets Fasted / FDC Fed|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin (BI 10773) and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
194429|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194430|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194431|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194432|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194433|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194434|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194435|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194436|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194437|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194438|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194439|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194440|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194441|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194442|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194443|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194444|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194445|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194446|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194447|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194448|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194449|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194450|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194451|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194452|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194453|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194454|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194455|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194456|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194457|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194458|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194459|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194460|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194461|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194462|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
194466|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194467|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194468|NCT01211197|E3|Reported Event|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194469|NCT01211197|E2|Reported Event|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
194470|NCT01211197|E1|Reported Event|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
194471|NCT01211184|B4|Baseline|Total|Total of all reporting groups
194472|NCT01211184|B3|Baseline|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
194473|NCT01211184|B2|Baseline|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
194474|NCT01211184|B1|Baseline|Fasting|patients undergo surgery in the fasting state
194475|NCT01211184|P3|Participant Flow|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
194476|NCT01211184|P2|Participant Flow|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
194477|NCT01211184|P1|Participant Flow|Fasting|patients undergo surgery in the fasting state
194478|NCT01211184|O3|Outcome|Nutrition Group|Drank a carbohydrate drink 800 ml in the evening before surgery and 400 ml 2 hrs before surgery
194479|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of water 2 hrs before surgery
194480|NCT01211184|O1|Outcome|Fasting|Fasting before surgery
194481|NCT01211184|O3|Outcome|Nutrition Group|Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
194482|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of tap water 2 hrs before entering the operating room
194483|NCT01211184|O1|Outcome|Fasting Group|Patients did not ingest any drink or food from midnight before the surgery.
194484|NCT01211184|E3|Reported Event|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
194485|NCT01211184|E2|Reported Event|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
194486|NCT01211184|E1|Reported Event|Fasting|patients undergo surgery in the fasting state
194487|NCT01211145|B5|Baseline|Total|Total of all reporting groups
194488|NCT01211145|B4|Baseline|ZOMIG 5 mg|ZOMIG nasal spray
194489|NCT01211145|B3|Baseline|ZOMIG 2.5 mg|ZOMIG nasal spray
194490|NCT01211145|B2|Baseline|ZOMIG 0.5 mg|ZOMIG nasal spray
194491|NCT01211145|B1|Baseline|Placebo|Placebo to ZOMIG nasal spray
194492|NCT01211145|P4|Participant Flow|ZOMIG 5 mg|ZOMIG nasal spray
194493|NCT01211145|P3|Participant Flow|ZOMIG 2.5 mg|ZOMIG nasal spray
194494|NCT01211145|P2|Participant Flow|ZOMIG 0.5 mg|ZOMIG nasal spray
194495|NCT01211145|P1|Participant Flow|Placebo|Placebo to ZOMIG nasal spray
194496|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194497|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194498|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194499|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194500|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194501|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194502|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194503|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194504|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194505|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194506|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194507|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194508|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194509|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194510|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194511|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194512|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194513|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194514|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194515|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194516|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
194517|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
194518|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
194519|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
194520|NCT01211145|E4|Reported Event|ZOMIG 5 mg|ZOMIG nasal spray
194521|NCT01211145|E3|Reported Event|ZOMIG 2.5 mg|ZOMIG nasal spray
194522|NCT01211145|E2|Reported Event|ZOMIG 0.5 mg|ZOMIG nasal spray
194523|NCT01211145|E1|Reported Event|Placebo|Placebo to ZOMIG nasal spray
194524|NCT01210820|B3|Baseline|Total|Total of all reporting groups
194525|NCT01210820|B2|Baseline|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194526|NCT01210820|B1|Baseline|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194527|NCT01210820|P2|Participant Flow|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
194528|NCT01210820|P1|Participant Flow|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
194868|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
225898|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
194529|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194530|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194531|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194532|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194533|NCT01210820|E2|Reported Event|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194534|NCT01210820|E1|Reported Event|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
194535|NCT01210807|B3|Baseline|Total|Total of all reporting groups
194536|NCT01210807|B2|Baseline|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
194537|NCT01210807|B1|Baseline|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
194538|NCT01210807|P2|Participant Flow|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
194539|NCT01210807|P1|Participant Flow|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
194540|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
194541|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
194542|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
194543|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
194544|NCT01210807|E2|Reported Event|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
194545|NCT01210807|E1|Reported Event|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
194546|NCT01210716|B1|Baseline|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
194547|NCT01210716|P2|Participant Flow|AMICUS First, Then Spectra|Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
194548|NCT01210716|P1|Participant Flow|Spectra First, Then AMICUS|Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
194549|NCT01210716|O1|Outcome|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
194550|NCT01210716|O2|Outcome|Spectra (Control)|Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
194551|NCT01210716|O1|Outcome|AMICUS (Test)|Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
194552|NCT01210716|E1|Reported Event|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
194553|NCT01210690|B1|Baseline|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194554|NCT01210690|P1|Participant Flow|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194555|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194556|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and is not influenced by the study protocol.
194557|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194558|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194869|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194559|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194560|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194561|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194562|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194563|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194564|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194565|NCT01210690|E1|Reported Event|Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
194566|NCT01210651|B3|Baseline|Total|Total of all reporting groups
194567|NCT01210651|B2|Baseline|Attention Control Education Group|Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
194568|NCT01210651|B1|Baseline|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
194569|NCT01210651|P2|Participant Flow|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
194570|NCT01210651|P1|Participant Flow|Hatha Yoga Practice Group|Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
194571|NCT01210651|O2|Outcome|Attention Control Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
194572|NCT01210651|O1|Outcome|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
194573|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
194574|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
194575|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
194576|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
194577|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
194578|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
194579|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
194580|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
194581|NCT01210651|E2|Reported Event|Attention Control Group|Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
194582|NCT01210651|E1|Reported Event|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.
194583|NCT01210495|B5|Baseline|Total|Total of all reporting groups
194584|NCT01210495|B4|Baseline|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194870|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194585|NCT01210495|B3|Baseline|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194586|NCT01210495|B2|Baseline|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194587|NCT01210495|B1|Baseline|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194588|NCT01210495|P4|Participant Flow|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194589|NCT01210495|P3|Participant Flow|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194590|NCT01210495|P2|Participant Flow|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194591|NCT01210495|P1|Participant Flow|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
194592|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194593|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194594|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194595|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194596|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194597|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194598|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194599|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194600|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194601|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194602|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194871|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194872|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194603|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194604|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194605|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194606|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194607|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194608|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194609|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194610|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194611|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194612|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194613|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194614|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194615|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194634|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
225899|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
194616|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194617|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194618|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194619|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194620|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194621|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194622|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194623|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194624|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194625|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194626|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194627|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194628|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194629|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194630|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194631|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194632|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
194633|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
194635|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
225900|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
194636|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194637|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194638|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194639|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194640|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194641|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194642|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194643|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194644|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194645|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194646|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194647|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194648|NCT01210495|E4|Reported Event|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
194801|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
225901|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
194649|NCT01210495|E3|Reported Event|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
194650|NCT01210495|E2|Reported Event|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.
194651|NCT01210495|E1|Reported Event|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
194652|NCT01210443|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194653|NCT01210443|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194654|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194655|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194656|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194657|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194658|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194659|NCT01210443|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
194660|NCT01210170|B1|Baseline|All Study Participants|• participant with asthma were enrolled in the study
194661|NCT01210170|P1|Participant Flow|All Study Participants|"• Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol~Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol~• Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol"
194662|NCT01210170|O4|Outcome|Mometasone Placebo and Albuterol Simultaneously|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
194663|NCT01210170|O3|Outcome|Mometasone and Albuterol Simultaneously|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol.
194664|NCT01210170|O2|Outcome|Mometasone Placebo 30 Minutes Before Albuterol|Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
194665|NCT01210170|O1|Outcome|Mometasone 30 Minutes Before Albuterol|• Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
194666|NCT01210170|O7|Outcome|All Participants Received Placebo -60 Min|placebo 60 minutes before inhalation of 180 mcg of albuterol
194667|NCT01210170|O6|Outcome|All Participants Received 400 mcg -60 Min|mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol
194668|NCT01210170|O5|Outcome|All Participants Received 200 mcg Mometasone-30 Min|mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol
194669|NCT01210170|O4|Outcome|All Participants Received Placebo Simultaneously With Albutero|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
194670|NCT01210170|O3|Outcome|All Participants Received 400 mcg Mometasone Simultaneous|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol
194671|NCT01210170|O2|Outcome|All Participants Received Placebo 30 Minutes Before Albuterol|mometasone placebo 30 minutes before albuterol 180 mcg inhalation
194672|NCT01210170|O1|Outcome|All Participants Received 400 mcg Mometasone-30 Min|mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation
194673|NCT01210170|E1|Reported Event|All Study Participants|Simultaneous inhalation of 400 µg mometasone DPI and 180 µg albuterol
194674|NCT01210144|B3|Baseline|Total|Total of all reporting groups
194675|NCT01210144|B2|Baseline|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194710|NCT01210118|E2|Reported Event|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
225902|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
194676|NCT01210144|B1|Baseline|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194677|NCT01210144|P2|Participant Flow|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194678|NCT01210144|P1|Participant Flow|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194679|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194680|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194681|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194682|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194683|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194684|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194756|NCT01209780|B1|Baseline|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194685|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194686|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194687|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194688|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194689|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194690|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194691|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194692|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194693|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
194709|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
194694|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
194695|NCT01210144|E2|Reported Event|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
194696|NCT01210144|E1|Reported Event|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
194697|NCT01210118|B3|Baseline|Total|Total of all reporting groups
194698|NCT01210118|B2|Baseline|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194699|NCT01210118|B1|Baseline|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
194700|NCT01210118|P2|Participant Flow|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194701|NCT01210118|P1|Participant Flow|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
194702|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194703|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
194704|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194705|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
194706|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194707|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
194708|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
194757|NCT01209780|P5|Participant Flow|Control (9-17 Years)|All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
194711|NCT01210118|E1|Reported Event|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
194712|NCT01210079|B3|Baseline|Total|Total of all reporting groups
194713|NCT01210079|B2|Baseline|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
194714|NCT01210079|B1|Baseline|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
194715|NCT01210079|P2|Participant Flow|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
194716|NCT01210079|P1|Participant Flow|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
194717|NCT01210079|O2|Outcome|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
194718|NCT01210079|O1|Outcome|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
194719|NCT01210079|E2|Reported Event|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
194720|NCT01210079|E1|Reported Event|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
194721|NCT01210001|B4|Baseline|Total|Total of all reporting groups
194722|NCT01210001|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194723|NCT01210001|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194724|NCT01210001|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194725|NCT01210001|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194726|NCT01210001|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194727|NCT01210001|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194728|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194729|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194730|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194731|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194732|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194733|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194734|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194735|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194736|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194737|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194738|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194739|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194740|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194741|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194742|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194743|NCT01210001|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
194744|NCT01210001|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
194745|NCT01210001|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
194746|NCT01209949|B1|Baseline|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194747|NCT01209949|P1|Participant Flow|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194748|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194749|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194750|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194751|NCT01209949|E1|Reported Event|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
194752|NCT01209780|B5|Baseline|Total|Total of all reporting groups
194753|NCT01209780|B4|Baseline|Control (9-17 Years)|All subjects received one dose of control TIV (eTIV_f).
194754|NCT01209780|B3|Baseline|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
194755|NCT01209780|B2|Baseline|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
194758|NCT01209780|P4|Participant Flow|TIV (9-17 Years)|All subjects in this group were non-naive and received one dose of investigational TIV.
194873|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194759|NCT01209780|P3|Participant Flow|Control (3 to < 4 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
194760|NCT01209780|P2|Participant Flow|Control (4-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
194761|NCT01209780|P1|Participant Flow|TIV (3-8 Years Old)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194762|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine (TIVf).
194763|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
194764|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194765|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194766|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine(TIVf).
194767|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
194768|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194769|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194770|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
194771|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
194772|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
194773|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
194774|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194775|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194776|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194777|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194778|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194779|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194874|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194780|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194781|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194782|NCT01209780|E4|Reported Event|Control (9-17 Years)|All subjects received one dose of control vaccine (TIV_f).
194783|NCT01209780|E3|Reported Event|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
194784|NCT01209780|E2|Reported Event|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
194785|NCT01209780|E1|Reported Event|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
194786|NCT01209767|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
194787|NCT01209767|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
194788|NCT01209767|O3|Outcome|Control|Area that received no treatment
194789|NCT01209767|O2|Outcome|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
194790|NCT01209767|O1|Outcome|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
194791|NCT01209767|E3|Reported Event|Control|Nothing was done to the area.
194792|NCT01209767|E2|Reported Event|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
194793|NCT01209767|E1|Reported Event|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
194794|NCT01209702|B3|Baseline|Total|Total of all reporting groups
194795|NCT01209702|B2|Baseline|Combined Tocilizumab|Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
194796|NCT01209702|B1|Baseline|Combined Placebo|Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
194797|NCT01209702|P4|Participant Flow|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194798|NCT01209702|P3|Participant Flow|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194799|NCT01209702|P2|Participant Flow|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194800|NCT01209702|P1|Participant Flow|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194875|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194876|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194802|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194803|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194804|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194805|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194806|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194807|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
194808|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
194809|NCT01209702|O1|Outcome|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2, including participants randomized to placebo who switched or escaped to tocilizumab treatment.
194810|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194811|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194812|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194813|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194814|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194815|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194816|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194817|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194861|NCT01209689|E1|Reported Event|Tocilizumab|Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.
194862|NCT01209624|B1|Baseline|Xalatan®|Once daily as 1 drop (topical application) in the evening
194863|NCT01209624|P1|Participant Flow|Xalatan®|Once daily as 1 drop (topical application) in the evening
194818|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194819|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194820|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194821|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194822|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194823|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194824|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194825|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194826|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194827|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194828|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194829|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194830|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194831|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194832|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194833|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194834|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194864|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194835|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194836|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194837|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194838|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194839|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194840|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194841|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194842|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
194843|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194844|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194845|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
194846|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
194847|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12.
194848|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12.
194849|NCT01209702|E4|Reported Event|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab.
194850|NCT01209702|E3|Reported Event|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab.
194851|NCT01209702|E2|Reported Event|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194852|NCT01209702|E1|Reported Event|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
194853|NCT01209689|B3|Baseline|Total|Total of all reporting groups
194854|NCT01209689|B2|Baseline|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
194855|NCT01209689|B1|Baseline|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
194856|NCT01209689|P2|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
194857|NCT01209689|P1|Participant Flow|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
194858|NCT01209689|O2|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
194859|NCT01209689|O1|Outcome|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
194860|NCT01209689|E2|Reported Event|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
194877|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194878|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194879|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194880|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194881|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194882|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194883|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194884|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194885|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194886|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194887|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194888|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194889|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194890|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194891|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
194892|NCT01209624|E1|Reported Event|Xalatan®|Once daily as 1 drop (topical application) in the evening
194893|NCT01209520|B1|Baseline|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
194894|NCT01209520|P1|Participant Flow|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
194895|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
194896|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
194897|NCT01209520|E1|Reported Event|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
194898|NCT01209286|B4|Baseline|Total|Total of all reporting groups
194899|NCT01209286|B3|Baseline|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194926|NCT01209286|O4|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
225903|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
194900|NCT01209286|B2|Baseline|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194901|NCT01209286|B1|Baseline|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194902|NCT01209286|P3|Participant Flow|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194903|NCT01209286|P2|Participant Flow|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194904|NCT01209286|P1|Participant Flow|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194905|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
194906|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
194907|NCT01209286|O3|Outcome|Blinatumomab 30 μg|Participants receiving blinatumomab 30 μg/m²/day.
194908|NCT01209286|O2|Outcome|Blinatumomab 15 μg|Participants receiving blinatumomab 15 μg/m²/day.
194909|NCT01209286|O1|Outcome|Blinatumomab 5 μg|Participants receiving blinatumomab 5 μg/m²/day.
194910|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194911|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194912|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194913|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194914|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194915|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194916|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194917|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194918|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194919|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194920|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194921|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194922|NCT01209286|O4|Outcome|Blinatumimab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194923|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194924|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194925|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194950|NCT01209286|E4|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
194927|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194928|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194929|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194930|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194931|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194932|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194933|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194934|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194935|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194936|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194937|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194938|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194939|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194940|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194941|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194942|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194943|NCT01209286|O3|Outcome|ABlinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194944|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194945|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194946|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194947|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194948|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194949|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
195152|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
194951|NCT01209286|E3|Reported Event|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
194952|NCT01209286|E2|Reported Event|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
194953|NCT01209286|E1|Reported Event|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
194954|NCT01209260|B3|Baseline|Total|Total of all reporting groups
194955|NCT01209260|B2|Baseline|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194956|NCT01209260|B1|Baseline|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194957|NCT01209260|P2|Participant Flow|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194958|NCT01209260|P1|Participant Flow|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194959|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
194960|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
194961|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
194962|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
194963|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194964|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194965|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194966|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194967|NCT01209260|E2|Reported Event|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194968|NCT01209260|E1|Reported Event|Radiofrequency Energy Needle (RF)|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
194969|NCT01209195|B3|Baseline|Total|Total of all reporting groups
194970|NCT01209195|B2|Baseline|MM-121 + Paclitaxel: Expansion Cohort|MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
194971|NCT01209195|B1|Baseline|MM-121 + Paclitaxel: Dose Escalation|"MM-121 plus Paclitaxel: Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Intermediate doses between cohorts 1 and 2 may also be considered."
194972|NCT01209195|P6|Participant Flow|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
194973|NCT01209195|P5|Participant Flow|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
194974|NCT01209195|P4|Participant Flow|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
194975|NCT01209195|P3|Participant Flow|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194976|NCT01209195|P2|Participant Flow|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194977|NCT01209195|P1|Participant Flow|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
194978|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
194979|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
194980|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
194981|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194982|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194983|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
194984|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
194985|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
194986|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
194987|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
194988|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
194989|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
194990|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
194991|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
194992|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
194993|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
194994|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
194995|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194996|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
194997|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
194998|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
194999|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
195000|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
195001|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
195002|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
195003|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
195004|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
195005|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
195006|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
195007|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
195008|NCT01209195|E2|Reported Event|MM-121 + Paclitaxel: Expansion Cohort|"Cohort 1:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV~Cohort 3:~MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV~Cohort 4:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
195009|NCT01209195|E1|Reported Event|MM-121 + Paclitaxel: Dose Escalation|"Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV"
195010|NCT01209143|B3|Baseline|Total|Total of all reporting groups
195011|NCT01209143|B2|Baseline|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
195012|NCT01209143|B1|Baseline|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
195013|NCT01209143|P2|Participant Flow|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
195014|NCT01209143|P1|Participant Flow|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
195015|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
195042|NCT01207583|B3|Baseline|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
195016|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
195017|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
195018|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
195019|NCT01209143|E2|Reported Event|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
195020|NCT01209143|E1|Reported Event|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
195021|NCT01208961|B1|Baseline|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
195022|NCT01208961|P2|Participant Flow|Lovaza-Epanova-Lovaza-Epanova|Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
195023|NCT01208961|P1|Participant Flow|Epanova-Lovaza-Epanova-Lovaza|Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
195024|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195025|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195026|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195027|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195028|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195029|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
195030|NCT01208961|E1|Reported Event|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
195031|NCT01207596|B1|Baseline|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195032|NCT01207596|P1|Participant Flow|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195033|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195034|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195035|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195036|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195037|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195038|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195039|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195040|NCT01207596|E1|Reported Event|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
195041|NCT01207583|B4|Baseline|Total|Total of all reporting groups
195151|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195043|NCT01207583|B2|Baseline|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
195044|NCT01207583|B1|Baseline|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
195045|NCT01207583|P3|Participant Flow|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
195046|NCT01207583|P2|Participant Flow|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
195047|NCT01207583|P1|Participant Flow|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
195048|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
195049|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195050|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195051|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195052|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195053|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195054|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccines as standard care as per the SmPC.
195055|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195056|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195057|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
195058|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195059|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195060|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195061|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195062|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195063|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195064|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195065|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195066|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
195067|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195068|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195069|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195070|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195071|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195072|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195073|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195074|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195075|NCT01207583|E9|Reported Event|Dose 2 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195076|NCT01207583|E8|Reported Event|Dose 1 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195077|NCT01207583|E7|Reported Event|Dose 3 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195078|NCT01207583|E6|Reported Event|Dose 2 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195079|NCT01207583|E5|Reported Event|Dose 1 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195080|NCT01207583|E4|Reported Event|Dose 4 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
195081|NCT01207583|E3|Reported Event|Dose 3 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
195344|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
195082|NCT01207583|E2|Reported Event|Dose 2 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
195083|NCT01207583|E1|Reported Event|Dose 1 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
195084|NCT01207570|B3|Baseline|Total|Total of all reporting groups
195085|NCT01207570|B2|Baseline|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
195086|NCT01207570|B1|Baseline|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
195087|NCT01207570|P2|Participant Flow|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
195088|NCT01207570|P1|Participant Flow|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
195089|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
195090|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
195091|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
195092|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
195093|NCT01207570|O2|Outcome|Passive Stretching|A single session of passive stretching
195094|NCT01207570|O1|Outcome|Endermotherapy|A single session of endermotherapy treatment
195095|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
195096|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
195097|NCT01207570|E2|Reported Event|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
195098|NCT01207570|E1|Reported Event|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
195099|NCT01208402|B3|Baseline|Total|Total of all reporting groups
195100|NCT01208402|B2|Baseline|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195101|NCT01208402|B1|Baseline|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195102|NCT01208402|P2|Participant Flow|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195103|NCT01208402|P1|Participant Flow|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195104|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195105|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195106|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195107|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195108|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195109|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195110|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195111|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195112|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195113|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195114|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195115|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
225904|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
195116|NCT01208402|E2|Reported Event|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
195117|NCT01208402|E1|Reported Event|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
195118|NCT01208337|B1|Baseline|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195119|NCT01208337|P1|Participant Flow|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195120|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195121|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195122|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195123|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195124|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195125|NCT01208337|E1|Reported Event|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
195126|NCT01208233|B7|Baseline|Total|Total of all reporting groups
195127|NCT01208233|B6|Baseline|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195128|NCT01208233|B5|Baseline|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195129|NCT01208233|B4|Baseline|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195130|NCT01208233|B3|Baseline|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195131|NCT01208233|B2|Baseline|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195132|NCT01208233|B1|Baseline|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195133|NCT01208233|P6|Participant Flow|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195134|NCT01208233|P5|Participant Flow|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195135|NCT01208233|P4|Participant Flow|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195136|NCT01208233|P3|Participant Flow|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195137|NCT01208233|P2|Participant Flow|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195138|NCT01208233|P1|Participant Flow|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195139|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195140|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195141|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
195142|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195143|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
195144|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195145|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195146|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195147|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
195148|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195149|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
195150|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195153|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
195154|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195155|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
195156|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195157|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195158|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195159|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
195160|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195161|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
195162|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195163|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195164|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195165|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
195166|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195167|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
195168|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195169|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195170|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195171|NCT01208233|O3|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195172|NCT01208233|O2|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195173|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195174|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195175|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195176|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195177|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195178|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195179|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195180|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195181|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195182|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195183|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195184|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195185|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195186|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195187|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195188|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195189|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195190|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195191|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195192|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195193|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195194|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195195|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195196|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195197|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195198|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195199|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195200|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195201|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195202|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195203|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195204|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195205|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
225905|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
195206|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195207|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195208|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195209|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195210|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195211|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195212|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195213|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195214|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195215|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195216|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195217|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195218|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195219|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195220|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195221|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195222|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195223|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195224|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195225|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195226|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195227|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195228|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195229|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195230|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195231|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195232|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195233|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195234|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195235|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195236|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195237|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195238|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195239|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195240|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195241|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195242|NCT01208233|E6|Reported Event|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
195243|NCT01208233|E5|Reported Event|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
195244|NCT01208233|E4|Reported Event|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
195245|NCT01208233|E3|Reported Event|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
195246|NCT01208233|E2|Reported Event|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
195247|NCT01208233|E1|Reported Event|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
195248|NCT01208220|B3|Baseline|Total|Total of all reporting groups
195249|NCT01208220|B2|Baseline|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
195250|NCT01208220|B1|Baseline|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
195251|NCT01208220|P2|Participant Flow|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
195252|NCT01208220|P1|Participant Flow|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
195253|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
195254|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
195345|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
195255|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
195256|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
195257|NCT01208220|E2|Reported Event|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
195258|NCT01208220|E1|Reported Event|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
195259|NCT01208207|B4|Baseline|Total|Total of all reporting groups
195260|NCT01208207|B3|Baseline|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily
195261|NCT01208207|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg once daily
195262|NCT01208207|B1|Baseline|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily
195263|NCT01208207|P7|Participant Flow|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
195264|NCT01208207|P6|Participant Flow|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
195265|NCT01208207|P5|Participant Flow|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
195266|NCT01208207|P4|Participant Flow|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
195267|NCT01208207|P3|Participant Flow|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
195268|NCT01208207|P2|Participant Flow|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
195269|NCT01208207|P1|Participant Flow|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
195270|NCT01208207|O7|Outcome|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
195271|NCT01208207|O6|Outcome|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
195272|NCT01208207|O5|Outcome|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
195273|NCT01208207|O4|Outcome|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
195274|NCT01208207|O3|Outcome|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
195275|NCT01208207|O2|Outcome|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
195276|NCT01208207|O1|Outcome|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
195277|NCT01208207|O2|Outcome|Etoricoxib 60 mg / 60 mg|Etoricoxib 60 mg in Part I and Etoricoxib 60 mg in Part II
195278|NCT01208207|O1|Outcome|Etoricoxib 60 mg/ 90 mg|Etoricoxib 60 mg in Part I and Etoricoxib 90 mg in Part II
195279|NCT01208207|O2|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
195280|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
195281|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
195282|NCT01208207|O1|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
195283|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
195284|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
195285|NCT01208207|E7|Reported Event|Naproxen 1000 mg|Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
195286|NCT01208207|E6|Reported Event|Etoricoxib 90 mg|Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
195287|NCT01208207|E5|Reported Event|Etoricoxib 60 mg|Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
195288|NCT01208207|E4|Reported Event|Naproxen 1000 mg / Naproxen 1000 mg|Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
195289|NCT01208207|E3|Reported Event|Etoricoxib 90 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
195290|NCT01208207|E2|Reported Event|Etoricoxib 60 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
195291|NCT01208207|E1|Reported Event|Etoricoxib 60 mg / Etoricoxib 60 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
195292|NCT01208181|B4|Baseline|Total|Total of all reporting groups
195293|NCT01208181|B3|Baseline|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195294|NCT01208181|B2|Baseline|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195295|NCT01208181|B1|Baseline|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195296|NCT01208181|P5|Participant Flow|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195297|NCT01208181|P4|Participant Flow|Etoricoxib 60/Etoricoxib 90mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
195298|NCT01208181|P3|Participant Flow|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
195299|NCT01208181|P2|Participant Flow|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195300|NCT01208181|P1|Participant Flow|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195346|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
195301|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195302|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
195303|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
195304|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195305|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195306|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195307|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
195308|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
195309|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195310|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195311|NCT01208181|O2|Outcome|Etoricoxib 60 mg/Etoricoxib 90 mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and etoricoxib 90 mg tablets Part 2 of the study.
195312|NCT01208181|O1|Outcome|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
195313|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195314|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195315|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195316|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195317|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195318|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195319|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195320|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195321|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195322|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195323|NCT01208181|E5|Reported Event|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
195324|NCT01208181|E4|Reported Event|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
195325|NCT01208181|E3|Reported Event|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
195326|NCT01208181|E2|Reported Event|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
195327|NCT01208181|E1|Reported Event|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
195328|NCT01207934|B4|Baseline|Total|Total of all reporting groups
195329|NCT01207934|B3|Baseline|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195330|NCT01207934|B2|Baseline|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195331|NCT01207934|B1|Baseline|Placebo|saline placebo for fourteen days
195332|NCT01207934|P3|Participant Flow|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195333|NCT01207934|P2|Participant Flow|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195334|NCT01207934|P1|Participant Flow|Placebo|saline placebo for fourteen days
195335|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
195336|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
195337|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
195338|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
195339|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
195340|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
195341|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
195342|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
195343|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
195347|NCT01207934|E3|Reported Event|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195348|NCT01207934|E2|Reported Event|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
195349|NCT01207934|E1|Reported Event|Placebo|saline placebo for fourteen days
195350|NCT01207765|B1|Baseline|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195351|NCT01207765|P1|Participant Flow|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195352|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195353|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195354|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195355|NCT01207765|E1|Reported Event|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
195356|NCT01207648|B1|Baseline|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195357|NCT01207648|P1|Participant Flow|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195358|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195359|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195360|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195361|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195362|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195363|NCT01207648|E1|Reported Event|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
195364|NCT01207492|B1|Baseline|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195365|NCT01207492|P1|Participant Flow|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195366|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195367|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195368|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195369|NCT01207492|E1|Reported Event|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
195370|NCT01207466|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
195371|NCT01207466|P2|Participant Flow|Nelfilcon A Comm'l / nelfilconA Invest'l|Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
195372|NCT01207466|P1|Participant Flow|Nelfilcon A Invest'l / nelfilconA Comm'l|Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
195373|NCT01207466|O2|Outcome|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
195374|NCT01207466|O1|Outcome|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
195375|NCT01207466|E2|Reported Event|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
195376|NCT01207466|E1|Reported Event|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
195377|NCT01207453|B3|Baseline|Total|Total of all reporting groups
195378|NCT01207453|B2|Baseline|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
195379|NCT01207453|B1|Baseline|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
195380|NCT01207453|P2|Participant Flow|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
195381|NCT01207453|P1|Participant Flow|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
195382|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195383|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195384|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195385|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195386|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195387|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195388|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195389|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195390|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195391|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195392|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Participants who take Milnacipran twice a day orally dosage was titrated up to target dosage of 50 mg (12.5 mg, 25 mg and 50 mg)."
195393|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195394|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
195395|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
195396|NCT01207453|E3|Reported Event|Washout Period|This 3-week period occurred after the first 6 weeks (when participants either received milnacipran or placebo). During the washout period, participants down titrated from the full dosage of milnacipran/placebo to nothing.
195397|NCT01207453|E2|Reported Event|Placebo|Participants received placebo tablets for 6 weeks. The tablets were identical in appearance to the milnacipran tablets.
195398|NCT01207453|E1|Reported Event|Milnacipran|Participants received milnacipran for 6 weeks. The dose was titrated according to the following schedule: 1) Days 1-3: milnacipran 12.5 mg twice daily, 2) Days 4-6: milnacipran 25 mg twice daily, 3) Days 7-42: milnacipran 50 mg twice daily. If participants could not tolerate the full dose, the dose was decreased to the highest tolerated dose.
195399|NCT01207427|B4|Baseline|Total|Total of all reporting groups
195400|NCT01207427|B3|Baseline|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
195401|NCT01207427|B2|Baseline|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195402|NCT01207427|B1|Baseline|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195448|NCT01207388|O5|Outcome|Cycle 1 MRD 10^-1|Participants with an MRD level 10^-1 at the end of cycle 1.
195403|NCT01207427|P3|Participant Flow|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
195404|NCT01207427|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195405|NCT01207427|P1|Participant Flow|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195406|NCT01207427|O3|Outcome|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
195407|NCT01207427|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195408|NCT01207427|O1|Outcome|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195409|NCT01207427|E3|Reported Event|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
195410|NCT01207427|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195411|NCT01207427|E1|Reported Event|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1- mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
195412|NCT01207414|B3|Baseline|Total|Total of all reporting groups
195413|NCT01207414|B2|Baseline|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195414|NCT01207414|B1|Baseline|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195415|NCT01207414|P2|Participant Flow|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195416|NCT01207414|P1|Participant Flow|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195417|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195418|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195419|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195420|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195449|NCT01207388|O4|Outcome|Cycle 1 MRD 10^-2|Participants with an MRD level 10^-2 at the end of cycle 1.
195450|NCT01207388|O3|Outcome|Cycle 1 MRD 10^-3|Participants with an MRD level 10^-3 at the end of cycle 1.
195421|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195422|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195423|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195424|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195425|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195426|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195427|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195428|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195429|NCT01207414|E2|Reported Event|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195430|NCT01207414|E1|Reported Event|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
195431|NCT01207401|B3|Baseline|Total|Total of all reporting groups
195432|NCT01207401|B2|Baseline|No Paracervical Block|
195433|NCT01207401|B1|Baseline|Paracervical Block|
195434|NCT01207401|P2|Participant Flow|No Paracervical Block|IUD insertion with no lidocaine injection
195435|NCT01207401|P1|Participant Flow|Paracervical Block|IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
195436|NCT01207401|O2|Outcome|No Paracervical Block|
195437|NCT01207401|O1|Outcome|Paracervical Block|
195438|NCT01207401|E2|Reported Event|No Paracervical Block|
195439|NCT01207401|E1|Reported Event|Paracervical Block|
195440|NCT01207388|B1|Baseline|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195441|NCT01207388|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.~Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab."
195442|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
195443|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
195444|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
195445|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
195446|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195447|NCT01207388|O6|Outcome|Cycle 1 MRD Unknown|Participants with an unknown MRD level at the end of cycle 1.
195451|NCT01207388|O2|Outcome|Cycle 1 MRD 10^-4|Participants with an MRD level 10^-4 at the end of cycle 1.
195452|NCT01207388|O1|Outcome|Cycle 1 MRD 10^-5|Participants with an MRD level 10^-5 at the end of cycle 1.
195453|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195454|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195455|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195456|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195457|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195458|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195459|NCT01207388|E1|Reported Event|Blinatumomab 15 µg/m2/d|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
195460|NCT01207219|B4|Baseline|Total|Total of all reporting groups
195461|NCT01207219|B3|Baseline|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195462|NCT01207219|B2|Baseline|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195463|NCT01207219|B1|Baseline|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195464|NCT01207219|P3|Participant Flow|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195465|NCT01207219|P2|Participant Flow|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195466|NCT01207219|P1|Participant Flow|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195467|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195468|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195469|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195470|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195471|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195472|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195473|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195474|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195475|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195476|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195477|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195478|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195479|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195480|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195481|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195482|NCT01207219|E3|Reported Event|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
195483|NCT01207219|E2|Reported Event|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
195484|NCT01207219|E1|Reported Event|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
195485|NCT01207102|B1|Baseline|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
195486|NCT01207102|P1|Participant Flow|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
195487|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
195488|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
195551|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
196261|NCT01204294|E7|Reported Event|A-GI+Met|alpha-glucosidase inhibitor plus metformin
195489|NCT01207102|E1|Reported Event|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
195490|NCT01206777|B1|Baseline|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195491|NCT01206777|P1|Participant Flow|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195492|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195493|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195494|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195495|NCT01206777|E1|Reported Event|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
195496|NCT01206738|B4|Baseline|Total|Total of all reporting groups
195497|NCT01206738|B3|Baseline|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
195498|NCT01206738|B2|Baseline|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
195499|NCT01206738|B1|Baseline|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
195500|NCT01206738|P3|Participant Flow|General Information|"No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
195501|NCT01206738|P2|Participant Flow|Alternative Intervention|"Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
195502|NCT01206738|P1|Participant Flow|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
195503|NCT01206738|O2|Outcome|Post|GPs receiving a postal invitation
195504|NCT01206738|O1|Outcome|Email|GPs receiving an email invitation
195505|NCT01206738|O3|Outcome|General Information|"No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.~General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing."
195506|NCT01206738|O2|Outcome|Alternative Intervention|"This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic~Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic"
195507|NCT01206738|O1|Outcome|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Persuasive communication: The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics."
195508|NCT01206738|E3|Reported Event|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
195509|NCT01206738|E2|Reported Event|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
195510|NCT01206738|E1|Reported Event|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
195511|NCT01206660|B3|Baseline|Total|Total of all reporting groups
195512|NCT01206660|B2|Baseline|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
196262|NCT01204294|E6|Reported Event|SU+Met|sulfonylurea plus metformin
195513|NCT01206660|B1|Baseline|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195514|NCT01206660|P2|Participant Flow|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
195515|NCT01206660|P1|Participant Flow|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195516|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
195517|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195518|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
195519|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195520|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
195521|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195522|NCT01206660|E2|Reported Event|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
195523|NCT01206660|E1|Reported Event|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
195524|NCT01206608|B3|Baseline|Total|Total of all reporting groups
195525|NCT01206608|B2|Baseline|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195526|NCT01206608|B1|Baseline|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195527|NCT01206608|P2|Participant Flow|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195528|NCT01206608|P1|Participant Flow|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195529|NCT01206608|O2|Outcome|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
195530|NCT01206608|O1|Outcome|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
195531|NCT01206608|E2|Reported Event|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195532|NCT01206608|E1|Reported Event|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195533|NCT01206595|B3|Baseline|Total|Total of all reporting groups
195534|NCT01206595|B2|Baseline|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195535|NCT01206595|B1|Baseline|SKY0402|Low-dose, low-mid dose, and mid-dose
195536|NCT01206595|P2|Participant Flow|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195537|NCT01206595|P1|Participant Flow|SKY0402|Low-dose, low-mid dose, and mid-dose
195538|NCT01206595|O4|Outcome|SKY0402 Mid Dose|A single dose of SKY0402 (mid dose) was administered intraoperatively by local infiltration.
195539|NCT01206595|O3|Outcome|SKY0402 Low-Mid Dose|A single dose of SKY0402 (low-mid dose) was administered intraoperatively by local infiltration.
195540|NCT01206595|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 (low dose) was administered intraoperatively by local infiltration.
195541|NCT01206595|O1|Outcome|Bupivacaine HCl|A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.
195542|NCT01206595|E2|Reported Event|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
195543|NCT01206595|E1|Reported Event|SKY0402|Low-dose, low-mid dose, and mid-dose
195544|NCT01206582|B3|Baseline|Total|Total of all reporting groups
195545|NCT01206582|B2|Baseline|Albumin|10 iv infusions for 8 weeks
195546|NCT01206582|B1|Baseline|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195547|NCT01206582|P2|Participant Flow|Albumin|10 iv infusions for 8 weeks
195548|NCT01206582|P1|Participant Flow|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195549|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195550|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195552|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195553|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195554|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195555|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195556|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195557|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195558|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195559|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195560|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195561|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195562|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195563|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195564|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195565|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195566|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195567|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195568|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195569|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
195570|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195571|NCT01206582|E2|Reported Event|Albumin|10 iv infusions for 8 weeks
195572|NCT01206582|E1|Reported Event|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
195573|NCT01206517|B7|Baseline|Total|Total of all reporting groups
195574|NCT01206517|B6|Baseline|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195575|NCT01206517|B5|Baseline|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195576|NCT01206517|B4|Baseline|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195577|NCT01206517|B3|Baseline|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195578|NCT01206517|B2|Baseline|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195579|NCT01206517|B1|Baseline|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195580|NCT01206517|P6|Participant Flow|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195581|NCT01206517|P5|Participant Flow|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195582|NCT01206517|P4|Participant Flow|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195583|NCT01206517|P3|Participant Flow|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195584|NCT01206517|P2|Participant Flow|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195585|NCT01206517|P1|Participant Flow|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195639|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195586|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195587|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195588|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195589|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195590|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195591|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195592|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195593|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195594|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195595|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195596|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195597|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195598|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195599|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195600|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195601|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195602|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195603|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195604|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195605|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195606|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
195607|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
195608|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195609|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195610|NCT01206517|E3|Reported Event|Asenapine 10 mg - Cohort 3a-d|"Participants 10-17 years of age:~Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12~Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8"
195611|NCT01206517|E2|Reported Event|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
195612|NCT01206517|E1|Reported Event|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
195613|NCT01206478|B3|Baseline|Total|Total of all reporting groups
195614|NCT01206478|B2|Baseline|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
195615|NCT01206478|B1|Baseline|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
195616|NCT01206478|P2|Participant Flow|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
195617|NCT01206478|P1|Participant Flow|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
195618|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
195619|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
195620|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
195621|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
195622|NCT01206478|E2|Reported Event|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
195623|NCT01206478|E1|Reported Event|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
195624|NCT01206439|B1|Baseline|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
195625|NCT01206439|P1|Participant Flow|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
195626|NCT01206439|O1|Outcome|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
195627|NCT01206439|E1|Reported Event|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
195628|NCT01206387|B3|Baseline|Total|Total of all reporting groups
195629|NCT01206387|B2|Baseline|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195630|NCT01206387|B1|Baseline|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195631|NCT01206387|P2|Participant Flow|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195632|NCT01206387|P1|Participant Flow|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195633|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195634|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195635|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195636|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195637|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195638|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195640|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195641|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195642|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195643|NCT01206387|E2|Reported Event|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
195644|NCT01206387|E1|Reported Event|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
195645|NCT01206322|B3|Baseline|Total|Total of all reporting groups
195646|NCT01206322|B2|Baseline|Diabetics|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
195647|NCT01206322|B1|Baseline|Healthy|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
195648|NCT01206322|P4|Participant Flow|Control Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
195649|NCT01206322|P3|Participant Flow|Control Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
195650|NCT01206322|P2|Participant Flow|Diabetes Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
195651|NCT01206322|P1|Participant Flow|Diabetes Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
195652|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
195653|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
195654|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
195655|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
195656|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
195657|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
195658|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
195659|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
195660|NCT01206322|E4|Reported Event|Control Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
195661|NCT01206322|E3|Reported Event|Control Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
195662|NCT01206322|E2|Reported Event|Diabetes Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
195663|NCT01206322|E1|Reported Event|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
195664|NCT01206140|B3|Baseline|Total|Total of all reporting groups
195665|NCT01206140|B2|Baseline|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195905|NCT01205581|B1|Baseline|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195666|NCT01206140|B1|Baseline|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195667|NCT01206140|P2|Participant Flow|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195668|NCT01206140|P1|Participant Flow|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195669|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195670|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195671|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195672|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195673|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195674|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195675|NCT01206140|E2|Reported Event|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
195676|NCT01206140|E1|Reported Event|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
195677|NCT01206101|B3|Baseline|Total|Total of all reporting groups
195678|NCT01206101|B2|Baseline|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195679|NCT01206101|B1|Baseline|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195680|NCT01206101|P2|Participant Flow|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195681|NCT01206101|P1|Participant Flow|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195682|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195683|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195684|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195685|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195686|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195687|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195688|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195689|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195690|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195691|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
225906|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
195692|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195693|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195694|NCT01206101|E2|Reported Event|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195695|NCT01206101|E1|Reported Event|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
195696|NCT01205828|B1|Baseline|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
195697|NCT01205828|P1|Participant Flow|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
195698|NCT01205828|O1|Outcome|Temozolomide and ABT-888 in HCC Patients|"Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Temozolomide: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days~ABT-888: ABT-888 40 mg BID PO Days 1-7 every 28 days"
195699|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
195700|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
195701|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
195702|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
195703|NCT01205828|E1|Reported Event|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
195704|NCT01205685|B1|Baseline|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195705|NCT01205685|P1|Participant Flow|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195706|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195707|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195708|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195709|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195710|NCT01205685|E1|Reported Event|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
195711|NCT01204671|B6|Baseline|Total|Total of all reporting groups
195712|NCT01204671|B5|Baseline|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195713|NCT01204671|B4|Baseline|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195714|NCT01204671|B3|Baseline|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195715|NCT01204671|B2|Baseline|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195716|NCT01204671|B1|Baseline|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195717|NCT01204671|P5|Participant Flow|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195718|NCT01204671|P4|Participant Flow|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195719|NCT01204671|P3|Participant Flow|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195720|NCT01204671|P2|Participant Flow|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195721|NCT01204671|P1|Participant Flow|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195722|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195723|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195724|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195725|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195726|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195727|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195728|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195729|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195730|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195731|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
195732|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195733|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195734|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195735|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195736|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195737|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195738|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195739|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195740|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195741|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195742|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195743|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195744|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195745|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195746|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195747|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195748|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195749|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195750|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195751|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195752|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195753|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195754|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195755|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195756|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195757|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195758|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195759|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195760|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195761|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195762|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195763|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195764|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195765|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195766|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195767|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195768|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195769|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195770|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195771|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195772|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195773|NCT01204671|E5|Reported Event|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195774|NCT01204671|E4|Reported Event|Fluarix Group|Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195775|NCT01204671|E3|Reported Event|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195776|NCT01204671|E2|Reported Event|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195777|NCT01204671|E1|Reported Event|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
195778|NCT01204658|B5|Baseline|Total|Total of all reporting groups
195906|NCT01205581|P6|Participant Flow|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195907|NCT01205581|P5|Participant Flow|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195908|NCT01205581|P4|Participant Flow|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195909|NCT01205581|P3|Participant Flow|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195779|NCT01204658|B4|Baseline|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195780|NCT01204658|B3|Baseline|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195781|NCT01204658|B2|Baseline|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195782|NCT01204658|B1|Baseline|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195783|NCT01204658|P4|Participant Flow|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195784|NCT01204658|P3|Participant Flow|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195785|NCT01204658|P2|Participant Flow|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195786|NCT01204658|P1|Participant Flow|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195787|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195788|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195789|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195790|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195791|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195792|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195793|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195794|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195795|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195796|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195797|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195910|NCT01205581|P2|Participant Flow|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195911|NCT01205581|P1|Participant Flow|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195912|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195913|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
196263|NCT01204294|E5|Reported Event|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
195798|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195799|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195800|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195801|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195802|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195803|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195804|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195805|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195806|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195914|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195915|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195916|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195917|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
196264|NCT01204294|E4|Reported Event|SU+Lina|sulfonylurea plus linagliptin
195807|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195808|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195809|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195810|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195811|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195812|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195813|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195814|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195815|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195816|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195817|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195818|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195819|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195820|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195821|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195822|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195823|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195824|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195825|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195918|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195919|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195920|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195921|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
196265|NCT01204294|E3|Reported Event|Glit+Lina|glitazone plus linagliptin
195826|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195827|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195828|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195829|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195830|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195831|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195832|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195833|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195834|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195922|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195923|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195924|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
195925|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
195926|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
195835|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195836|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195837|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195838|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195839|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195840|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195841|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195842|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195843|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195844|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195845|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195846|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195847|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195848|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195849|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195850|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195851|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195852|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195853|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195927|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
195928|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
195929|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
195930|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
195931|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
195854|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195855|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195856|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195857|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195858|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195859|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195860|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195861|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195862|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195932|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
195933|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
195934|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195935|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195936|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195863|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195864|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195865|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195866|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195867|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195868|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195869|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195870|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195871|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195872|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195873|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195874|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195875|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195876|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195877|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195878|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195879|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195880|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195881|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195937|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195938|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195939|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195940|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
196266|NCT01204294|E2|Reported Event|Glin+Lina|glinide plus linagliptin
195882|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195883|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195884|NCT01204658|O1|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195885|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195886|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195887|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195888|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195889|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195890|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195941|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195942|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195943|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195944|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
196267|NCT01204294|E1|Reported Event|Bigu+Lina|biguanide plus linagliptin
195891|NCT01204658|E4|Reported Event|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
195892|NCT01204658|E3|Reported Event|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
195893|NCT01204658|E2|Reported Event|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195894|NCT01204658|E1|Reported Event|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
195895|NCT01205646|B1|Baseline|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
195896|NCT01205646|P1|Participant Flow|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
195897|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
195898|NCT01205646|E1|Reported Event|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
195899|NCT01205581|B7|Baseline|Total|Total of all reporting groups
195900|NCT01205581|B6|Baseline|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195901|NCT01205581|B5|Baseline|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195902|NCT01205581|B4|Baseline|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195903|NCT01205581|B3|Baseline|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195904|NCT01205581|B2|Baseline|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
225907|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
195945|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195946|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
195947|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
195948|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
195949|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
195950|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
195951|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
195952|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
195953|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
195954|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
195955|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
195956|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
195957|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
195958|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
195959|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
195960|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
195961|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
195962|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195963|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195964|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195965|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195966|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195967|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195968|NCT01205581|E6|Reported Event|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
195969|NCT01205581|E5|Reported Event|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
195970|NCT01205581|E4|Reported Event|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
195971|NCT01205581|E3|Reported Event|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
195972|NCT01205581|E2|Reported Event|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
195973|NCT01205581|E1|Reported Event|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
195974|NCT01205503|B3|Baseline|Total|Total of all reporting groups
195975|NCT01205503|B2|Baseline|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
195976|NCT01205503|B1|Baseline|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
195977|NCT01205503|P2|Participant Flow|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
195978|NCT01205503|P1|Participant Flow|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
195979|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195980|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195981|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
196073|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196074|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
195982|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195983|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195984|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195985|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195986|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195987|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195988|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
195989|NCT01205503|E2|Reported Event|Saline|"Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization~Infused over 15 minutes"
195990|NCT01205503|E1|Reported Event|Mesna|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
195991|NCT01205451|B3|Baseline|Total|Total of all reporting groups
195992|NCT01205451|B2|Baseline|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195993|NCT01205451|B1|Baseline|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195994|NCT01205451|P2|Participant Flow|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195995|NCT01205451|P1|Participant Flow|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195996|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195997|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
195998|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196075|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196076|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196077|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
195999|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196000|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196001|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196002|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196003|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196004|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196005|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196006|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196007|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196008|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196009|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196010|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196011|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196012|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196013|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196014|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196078|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196079|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196080|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196015|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196016|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196017|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196018|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196019|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196020|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196021|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196022|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196023|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196024|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196025|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196026|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196027|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196028|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196029|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196030|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196081|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196082|NCT01205269|E3|Reported Event|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196083|NCT01205269|E2|Reported Event|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196031|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196032|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196033|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196034|NCT01205451|E2|Reported Event|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196035|NCT01205451|E1|Reported Event|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
196036|NCT01205399|B1|Baseline|AlloMax Surgical Graft Group|
196037|NCT01205399|P1|Participant Flow|AlloMax Surgical Graft Group|The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
196038|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
196039|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
196040|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
196041|NCT01205399|E1|Reported Event|AlloMax Surgical Graft Group|
196042|NCT01205269|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 6 sequences of drug or placebo.
196043|NCT01205269|P6|Participant Flow|First Placebo, Then 50 mcg, Then 200 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
196044|NCT01205269|P5|Participant Flow|First Placebo, Then 200 mcg, Then 50 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
196045|NCT01205269|P4|Participant Flow|First 200 mcg, Then 50 mcg, Then Placebo|period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
196046|NCT01205269|P3|Participant Flow|First 200 mcg, Then Placebo, Then 50 mcg|period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
196047|NCT01205269|P2|Participant Flow|First 50 mcg, Then Placebo, Then 200 mcg|period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
196048|NCT01205269|P1|Participant Flow|First 50 mcg, Then 200 mcg, Then Placebo|period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
196049|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196050|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196051|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196052|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196053|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196054|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196055|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196056|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196057|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196058|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196059|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196060|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196061|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196062|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196063|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196064|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196065|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196066|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196067|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196068|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196069|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196070|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
196071|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
196072|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196084|NCT01205269|E1|Reported Event|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
196085|NCT01205230|B3|Baseline|Total|Total of all reporting groups
196086|NCT01205230|B2|Baseline|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
196087|NCT01205230|B1|Baseline|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196088|NCT01205230|P2|Participant Flow|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
196089|NCT01205230|P1|Participant Flow|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196090|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196091|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196092|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196093|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196094|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196095|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196096|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196097|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196098|NCT01205230|O1|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196099|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196100|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196101|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196102|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196103|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196104|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196105|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196106|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196107|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196108|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196109|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196110|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196111|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196112|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196113|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196252|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
196253|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
196114|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196115|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196116|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196117|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196118|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196119|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196120|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196121|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196122|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196123|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196124|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196125|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196126|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196127|NCT01205230|E4|Reported Event|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
196128|NCT01205230|E3|Reported Event|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
196129|NCT01205230|E2|Reported Event|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
196130|NCT01205230|E1|Reported Event|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
196131|NCT01205126|B3|Baseline|Total|Total of all reporting groups
196132|NCT01205126|B2|Baseline|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196133|NCT01205126|B1|Baseline|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196134|NCT01205126|P2|Participant Flow|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196135|NCT01205126|P1|Participant Flow|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196136|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196137|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196138|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196139|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196140|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196141|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196142|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196254|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
196255|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
196143|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196144|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196145|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196146|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196147|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196148|NCT01205126|E2|Reported Event|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196149|NCT01205126|E1|Reported Event|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
196150|NCT01205035|B3|Baseline|Total|Total of all reporting groups
196151|NCT01205035|B2|Baseline|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196152|NCT01205035|B1|Baseline|Observation|Observation; No treatment given
196153|NCT01205035|P2|Participant Flow|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196154|NCT01205035|P1|Participant Flow|Observation|Observation; No treatment given
196155|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196156|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
196157|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196158|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
196159|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196160|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
196161|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196162|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
196163|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196164|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
196165|NCT01205035|E2|Reported Event|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
196166|NCT01205035|E1|Reported Event|Observation|Observation; No treatment given
196167|NCT01204853|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196168|NCT01204853|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196169|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196170|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196171|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196256|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
196172|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196173|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196174|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196175|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196176|NCT01204853|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
196177|NCT01204788|B3|Baseline|Total|Total of all reporting groups
196178|NCT01204788|B2|Baseline|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
196179|NCT01204788|B1|Baseline|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
196180|NCT01204788|P2|Participant Flow|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
196181|NCT01204788|P1|Participant Flow|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
196182|NCT01204788|O2|Outcome|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
196183|NCT01204788|O1|Outcome|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
196184|NCT01204788|E2|Reported Event|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
196185|NCT01204788|E1|Reported Event|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
196186|NCT01204736|B5|Baseline|Total|Total of all reporting groups
196187|NCT01204736|B4|Baseline|Group 4|Unimpaired control subjects
196188|NCT01204736|B3|Baseline|Group 3|Subjects with cervical SCI who have not had tendon transfers
196189|NCT01204736|B2|Baseline|Group 2|Subjects with biceps-to-triceps tendon transfers
196190|NCT01204736|B1|Baseline|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
196191|NCT01204736|P4|Participant Flow|Group 4|Unimpaired control subjects
196192|NCT01204736|P3|Participant Flow|Group 3|Subjects with cervical SCI who have not had tendon transfers
196193|NCT01204736|P2|Participant Flow|Group 2|Subjects with biceps-to-triceps tendon transfers
196194|NCT01204736|P1|Participant Flow|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
196195|NCT01204736|O4|Outcome|Group 4|Unimpaired control subjects
196196|NCT01204736|O3|Outcome|Group 3|Subjects with cervical SCI who have not had tendon transfers
196197|NCT01204736|O2|Outcome|Group 2|Subjects with biceps-to-triceps tendon transfers
196198|NCT01204736|O1|Outcome|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
196199|NCT01204736|E4|Reported Event|Group 4|Unimpaired control subjects
196200|NCT01204736|E3|Reported Event|Group 3|Subjects with cervical SCI who have not had tendon transfers
196201|NCT01204736|E2|Reported Event|Group 2|Subjects with biceps-to-triceps tendon transfers
196202|NCT01204736|E1|Reported Event|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
196203|NCT01204697|B3|Baseline|Total|Total of all reporting groups
196204|NCT01204697|B2|Baseline|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196205|NCT01204697|B1|Baseline|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196206|NCT01204697|P2|Participant Flow|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196207|NCT01204697|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
196257|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
196208|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196209|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196210|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196211|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196212|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196213|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196214|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196215|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196216|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196217|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196218|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196219|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196220|NCT01204697|E2|Reported Event|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
196221|NCT01204697|E1|Reported Event|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
196222|NCT01204398|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196223|NCT01204398|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196224|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196225|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196226|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196227|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196228|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196229|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196230|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
196231|NCT01204398|E1|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
196232|NCT01204294|B8|Baseline|Total|Total of all reporting groups
196233|NCT01204294|B7|Baseline|A-GI+Met|alpha-glucosidase inhibitor plus metformin
196234|NCT01204294|B6|Baseline|SU+Met|sulfonylurea plus metformin
196235|NCT01204294|B5|Baseline|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
196236|NCT01204294|B4|Baseline|SU+Lina|sulfonylurea plus linagliptin
196237|NCT01204294|B3|Baseline|Glit+Lina|glitazone plus linagliptin
196238|NCT01204294|B2|Baseline|Glin+Lina|glinide plus linagliptin
196239|NCT01204294|B1|Baseline|Bigu+Lina|biguanide plus linagliptin
196240|NCT01204294|P7|Participant Flow|A-GI+Met|alpha-glucosidase inhibitor plus metformin
196241|NCT01204294|P6|Participant Flow|SU+Met|sulfonylurea plus metformin
196242|NCT01204294|P5|Participant Flow|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
196243|NCT01204294|P4|Participant Flow|SU+Lina|sulfonylurea plus linagliptin
196244|NCT01204294|P3|Participant Flow|Glit+Lina|glitazone plus linagliptin
196245|NCT01204294|P2|Participant Flow|Glin+Lina|glinide plus linagliptin
196246|NCT01204294|P1|Participant Flow|Bigu+Lina|biguanide plus linagliptin
196247|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
196248|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
196249|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
196250|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
196251|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
196268|NCT01204255|B1|Baseline|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
196269|NCT01204255|P1|Participant Flow|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
196270|NCT01204255|O1|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
196271|NCT01204255|E1|Reported Event|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
196272|NCT01203956|B1|Baseline|All Evaluable Subjects|All subjects completing both two-week periods of crossover study, with evaluable results for each period.
196273|NCT01203956|P2|Participant Flow|Standard First, Then Smartflex|First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
196274|NCT01203956|P1|Participant Flow|SmartFlex First, Then Standard|First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
196275|NCT01203956|O2|Outcome|Standard|Used CPAP device without SmartFlex engaged, in either first or second two-week period.
196276|NCT01203956|O1|Outcome|SmartFlex|Used CPAP device with SmartFlex engaged, in either first or second two-week period.
196277|NCT01203956|E3|Reported Event||From data available it cannot be determined which mode the subject was using at the time of this event.
196278|NCT01203956|E2|Reported Event|Standard|CPAP device used without SmartFlex engaged, either in first or second two-week period.
196279|NCT01203956|E1|Reported Event|SmartFlex|CPAP device used with SmartFlex engaged, either in first or second two-week period.
196280|NCT01203917|B1|Baseline|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196281|NCT01203917|P1|Participant Flow|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196282|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196283|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196284|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196285|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196286|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196287|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196288|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
196289|NCT01203917|E1|Reported Event|Gefitinib 250 mg|
196290|NCT01203878|B4|Baseline|Total|Total of all reporting groups
196291|NCT01203878|B3|Baseline|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
196292|NCT01203878|B2|Baseline|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196293|NCT01203878|B1|Baseline|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196294|NCT01203878|P3|Participant Flow|Non-randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
196295|NCT01203878|P2|Participant Flow|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196296|NCT01203878|P1|Participant Flow|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196297|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196298|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196299|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196300|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196301|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196302|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196303|NCT01203878|E3|Reported Event|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
196304|NCT01203878|E2|Reported Event|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
196305|NCT01203878|E1|Reported Event|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
196306|NCT01203852|B1|Baseline|Metoprolol + Chlorthalidone|"This group was assigned to the following: Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.~Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily~Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily~Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
196307|NCT01203852|P1|Participant Flow|Metoprolol + Chlorthalidone|"This group was assigned the following:~(Metoprolol 8 weeks): Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks.~(Washout 2 weeks): Then will washout from all study medication.~(Chlorthalidone 8 weeks): participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks."
196308|NCT01203852|O1|Outcome|Adverse Metabolic Effects|Change in glucose after treatment with study medications
196309|NCT01203852|O3|Outcome|Chlorthalidone Only|Study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
196310|NCT01203852|O2|Outcome|Metorprolol Only|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded.
196311|NCT01203852|O1|Outcome|Metoprolol + Chlorthalidone|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
196312|NCT01203852|E1|Reported Event|All Study Participants|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. The subjects were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
196313|NCT01203787|B3|Baseline|Total|Total of all reporting groups
196314|NCT01203787|B2|Baseline|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196315|NCT01203787|B1|Baseline|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196316|NCT01203787|P2|Participant Flow|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196317|NCT01203787|P1|Participant Flow|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196318|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196319|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196320|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196321|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196322|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196323|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196324|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196325|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196922|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196326|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196327|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196328|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|"200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24~Sorafenib Standard Dosing Regimen: Sorafenib 400 mg twice daily until wk 24 or end of treatment"
196329|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|"Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24~Sorafenib Ramp-Up Regimen: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily"
196330|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196331|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196332|NCT01203787|E2|Reported Event|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
196333|NCT01203787|E1|Reported Event|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
196334|NCT01203644|B3|Baseline|Total|Total of all reporting groups
196335|NCT01203644|B2|Baseline|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
196336|NCT01203644|B1|Baseline|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
196337|NCT01203644|P2|Participant Flow|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
196338|NCT01203644|P1|Participant Flow|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
196339|NCT01203644|O5|Outcome|SKY0402 High Dose|Single administration of SKY0402 (high dose) in a 40-mL volume via local infiltration
196340|NCT01203644|O4|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 (high-mid dose) in a 40-mL volume via local infiltration
196341|NCT01203644|O3|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 (low-mid dose) in a 40-mL volume via local infiltration
196342|NCT01203644|O2|Outcome|SKY0402 Low Dose|Single administration of SKY0402 (low dose) in a 40-mL volume via local infiltration
196343|NCT01203644|O1|Outcome|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
196344|NCT01203644|E2|Reported Event|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
196345|NCT01203644|E1|Reported Event|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
196346|NCT01203319|B4|Baseline|Total|Total of all reporting groups
196347|NCT01203319|B3|Baseline|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196348|NCT01203319|B2|Baseline|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196349|NCT01203319|B1|Baseline|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196350|NCT01203319|P3|Participant Flow|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196351|NCT01203319|P2|Participant Flow|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196352|NCT01203319|P1|Participant Flow|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196353|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196354|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196355|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196356|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196357|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196358|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196923|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196359|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196360|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196361|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196362|NCT01203319|E3|Reported Event|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196363|NCT01203319|E2|Reported Event|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196364|NCT01203319|E1|Reported Event|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
196365|NCT01203098|B4|Baseline|Total|Total of all reporting groups
196366|NCT01203098|B3|Baseline|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
196367|NCT01203098|B2|Baseline|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
196368|NCT01203098|B1|Baseline|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
196369|NCT01203098|P3|Participant Flow|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
196370|NCT01203098|P2|Participant Flow|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
196371|NCT01203098|P1|Participant Flow|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
196372|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
196373|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
196374|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
196375|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
196376|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
196377|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
196378|NCT01203098|E3|Reported Event|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
196379|NCT01203098|E2|Reported Event|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
196380|NCT01203098|E1|Reported Event|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
196381|NCT01203072|B6|Baseline|Total|Total of all reporting groups
196382|NCT01203072|B5|Baseline|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
196383|NCT01203072|B4|Baseline|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
196384|NCT01203072|B3|Baseline|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
196385|NCT01203072|B2|Baseline|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
196386|NCT01203072|B1|Baseline|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
196387|NCT01203072|P5|Participant Flow|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
196388|NCT01203072|P4|Participant Flow|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
196389|NCT01203072|P3|Participant Flow|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
196390|NCT01203072|P2|Participant Flow|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
196391|NCT01203072|P1|Participant Flow|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
196392|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
196393|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
196394|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
196395|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
196396|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
196397|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
196398|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
196399|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
196400|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
196401|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
196402|NCT01203072|E5|Reported Event|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
196403|NCT01203072|E4|Reported Event|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
196404|NCT01203072|E3|Reported Event|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
196405|NCT01203072|E2|Reported Event|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
196406|NCT01203072|E1|Reported Event|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
196407|NCT01203046|B3|Baseline|Total|Total of all reporting groups
196408|NCT01203046|B2|Baseline|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
196409|NCT01203046|B1|Baseline|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
196410|NCT01203046|P2|Participant Flow|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
196411|NCT01203046|P1|Participant Flow|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
196412|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|Patients with 3 days therapy
196413|NCT01203046|O1|Outcome|GROUP A - 7 DAYS THERAPY|Patients with 7 days therapy
196414|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
196415|NCT01203046|O1|Outcome|GROUP A: 7 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
196416|NCT01203046|E2|Reported Event|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
196417|NCT01203046|E1|Reported Event|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
196418|NCT01202955|B3|Baseline|Total|Total of all reporting groups
196419|NCT01202955|B2|Baseline|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196420|NCT01202955|B1|Baseline|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196421|NCT01202955|P2|Participant Flow|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196422|NCT01202955|P1|Participant Flow|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196423|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196424|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196425|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196426|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196427|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196428|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
196429|NCT01202955|E2|Reported Event|Placebo First, Then Tolcapone|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
196430|NCT01202955|E1|Reported Event|Tolcapone First, Then Placebo|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
196431|NCT01202903|B3|Baseline|Total|Total of all reporting groups
196432|NCT01202903|B2|Baseline|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196433|NCT01202903|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196850|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196434|NCT01202903|P2|Participant Flow|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196435|NCT01202903|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196436|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196437|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196438|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196439|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196440|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196441|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196442|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196443|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196444|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196445|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196446|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196447|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196448|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196449|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196450|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196451|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196452|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196453|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196454|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196455|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196456|NCT01202903|E2|Reported Event|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
196457|NCT01202903|E1|Reported Event|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
196458|NCT01202877|B4|Baseline|Total|Total of all reporting groups
196459|NCT01202877|B3|Baseline|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
196460|NCT01202877|B2|Baseline|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196461|NCT01202877|B1|Baseline|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine (AZA) 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196462|NCT01202877|P3|Participant Flow|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
196463|NCT01202877|P2|Participant Flow|Phase I: 5-azacytidine + PKC412 50 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196464|NCT01202877|P1|Participant Flow|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196465|NCT01202877|O1|Outcome|5-azacytidine + PKC412|"5-azacytidine 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).~5-azacytidine: Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.~PKC412: Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily)."
196466|NCT01202877|O3|Outcome|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
196467|NCT01202877|O2|Outcome|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196468|NCT01202877|O1|Outcome|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196469|NCT01202877|E3|Reported Event|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
196470|NCT01202877|E2|Reported Event|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196471|NCT01202877|E1|Reported Event|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
196472|NCT01202747|B1|Baseline|LipiFlow Treatment|Treatment with LipiFlow device
196473|NCT01202747|P1|Participant Flow|LipiFlow Treatment|Treatment with LipiFlow device
196474|NCT01202747|O1|Outcome|LipiFlow Treatment|Treatment with LipiFlow device
196475|NCT01202747|E1|Reported Event|LipiFlow Treatment|Treatment with LipiFlow device
196476|NCT01202656|B3|Baseline|Total|Total of all reporting groups
196477|NCT01202656|B2|Baseline|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation~then~G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
196478|NCT01202656|B1|Baseline|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation~then~Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
196479|NCT01202656|P2|Participant Flow|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
196480|NCT01202656|P1|Participant Flow|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation"
196481|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
196482|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
196483|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
196484|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
196485|NCT01202656|E2|Reported Event|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
196486|NCT01202656|E1|Reported Event|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
196487|NCT01202643|B3|Baseline|Total|Total of all reporting groups
196488|NCT01202643|B2|Baseline|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
196489|NCT01202643|B1|Baseline|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
196490|NCT01202643|P2|Participant Flow|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
196491|NCT01202643|P1|Participant Flow|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
196492|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
196493|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
196494|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
196495|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
196496|NCT01202643|E2|Reported Event|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
196497|NCT01202643|E1|Reported Event|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
196498|NCT01202591|B7|Baseline|Total|Total of all reporting groups
196499|NCT01202591|B6|Baseline|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
196500|NCT01202591|B5|Baseline|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
196501|NCT01202591|B4|Baseline|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
196502|NCT01202591|B3|Baseline|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
196503|NCT01202591|B2|Baseline|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
196504|NCT01202591|B1|Baseline|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
196505|NCT01202591|P6|Participant Flow|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
196506|NCT01202591|P5|Participant Flow|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
196507|NCT01202591|P4|Participant Flow|AZD4547 80mg bd 2w/1w + Ex|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
196508|NCT01202591|P3|Participant Flow|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
196509|NCT01202591|P2|Participant Flow|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
196510|NCT01202591|P1|Participant Flow|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
196511|NCT01202591|O6|Outcome|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
196512|NCT01202591|O5|Outcome|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
196513|NCT01202591|O4|Outcome|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
196514|NCT01202591|O3|Outcome|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
196515|NCT01202591|O2|Outcome|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
196516|NCT01202591|O1|Outcome|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
196517|NCT01202591|E6|Reported Event|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
196518|NCT01202591|E5|Reported Event|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
196519|NCT01202591|E4|Reported Event|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
196520|NCT01202591|E3|Reported Event|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
196521|NCT01202591|E2|Reported Event|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
196522|NCT01202591|E1|Reported Event|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
196523|NCT01202578|B1|Baseline|Tympanostomy Tube Placement Using the Tube Delivery System|
196524|NCT01202578|P1|Participant Flow|Tympanostomy Tube Placement Using the Tube Delivery System|
196525|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
196526|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
196527|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
196528|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
196529|NCT01202578|E1|Reported Event|Safety Events|Safety in terms of number affected subjects in total number of subjects.
196530|NCT01202565|B1|Baseline|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196531|NCT01202565|P1|Participant Flow|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196532|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196533|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196534|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196535|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196536|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196537|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196538|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196539|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196540|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196541|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196542|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196543|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196544|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196545|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196546|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196547|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196548|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196549|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196550|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196551|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196552|NCT01202565|E1|Reported Event|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
196553|NCT01202279|B3|Baseline|Total|Total of all reporting groups
196554|NCT01202279|B2|Baseline|Placebo|Placebo given bid with a full glass of water for 7 days
196555|NCT01202279|B1|Baseline|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
196556|NCT01202279|P2|Participant Flow|Placebo|Placebo given bid with a full glass of water for 7 days
196557|NCT01202279|P1|Participant Flow|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
196558|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
196559|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
196560|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
196561|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
196562|NCT01202279|E2|Reported Event|Placebo|Placebo given bid with a full glass of water for 7 days
196563|NCT01202279|E1|Reported Event|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
196564|NCT01202253|B1|Baseline|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196565|NCT01202253|P1|Participant Flow|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196566|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196567|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196568|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196569|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196570|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196571|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196572|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196573|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196574|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196575|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196576|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196577|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196578|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196579|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196580|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196581|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196582|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196583|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196584|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196585|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196586|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196587|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196588|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196589|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196590|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196591|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196592|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196593|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196594|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196595|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196596|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196597|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196598|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196599|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196600|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196601|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196602|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196603|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196604|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196605|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196606|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
196607|NCT01202253|E1|Reported Event|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
196728|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196608|NCT01202227|B1|Baseline|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196609|NCT01202227|P1|Participant Flow|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196610|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196611|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196612|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196613|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196614|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196615|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196616|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196617|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196618|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196619|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196620|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196914|NCT01201317|B4|Baseline|Total|Total of all reporting groups
196621|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196622|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196623|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196624|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196625|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196626|NCT01202227|E1|Reported Event|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
196627|NCT01202188|B6|Baseline|Total|Total of all reporting groups
196628|NCT01202188|B5|Baseline|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196629|NCT01202188|B4|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196630|NCT01202188|B3|Baseline|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196631|NCT01202188|B2|Baseline|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196632|NCT01202188|B1|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196633|NCT01202188|P5|Participant Flow|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196634|NCT01202188|P4|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196635|NCT01202188|P3|Participant Flow|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196636|NCT01202188|P2|Participant Flow|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196637|NCT01202188|P1|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196638|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196639|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196640|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196641|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196642|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196643|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196644|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196645|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196646|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196647|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196648|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196649|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196650|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196651|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196652|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196653|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196654|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196655|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196656|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196657|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196658|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196659|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196660|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196661|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196845|NCT01201798|P2|Participant Flow|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196662|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196663|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196664|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196665|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196666|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196667|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196668|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196669|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196670|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196671|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196672|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196673|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196674|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196675|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196676|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196677|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196678|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196679|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196680|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196681|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196682|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196683|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196846|NCT01201798|P1|Participant Flow|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196684|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196685|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196686|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196687|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196688|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196689|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196690|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196691|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196692|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196693|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196694|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196695|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196696|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196697|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196698|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196699|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196700|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196701|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196702|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196703|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196704|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196705|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196847|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196706|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196707|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196708|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196709|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196710|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196711|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196712|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196713|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196714|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196715|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196716|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196717|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196718|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196719|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196720|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196721|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196722|NCT01202188|O2|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via the manufacturer's proprietary device for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196723|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196724|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196725|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196726|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196727|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196848|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196729|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196730|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196731|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196732|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196733|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196734|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196735|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196736|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
196737|NCT01202188|E5|Reported Event|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196738|NCT01202188|E4|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196739|NCT01202188|E3|Reported Event|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196740|NCT01202188|E2|Reported Event|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196741|NCT01202188|E1|Reported Event|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
196742|NCT01202162|B3|Baseline|Total|Total of all reporting groups
196743|NCT01202162|B2|Baseline|Sevoflurane|Administration of Sevoflurane
196744|NCT01202162|B1|Baseline|Desflurane|Administration of Desflurane
196745|NCT01202162|P2|Participant Flow|Sevoflurane|Administration of Sevoflurane
196746|NCT01202162|P1|Participant Flow|Desflurane|Administration of Desflurane
196747|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
196748|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
196749|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
196750|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
196751|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
196752|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
196753|NCT01202162|E2|Reported Event|Sevoflurane|Administration of Sevoflurane
196754|NCT01202162|E1|Reported Event|Desflurane|Administration of Desflurane
196755|NCT01202110|B1|Baseline|Control|Control
196756|NCT01202110|P2|Participant Flow|Propranolol|Propranolol
196757|NCT01202110|P1|Participant Flow|Control|Control
196758|NCT01202110|O1|Outcome|Propranolol|0
196759|NCT01202110|E1|Reported Event|Control|10
196760|NCT01202071|B1|Baseline|Entire Study Population: Group A, Group B, Group C, Group D|"Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.~Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg~Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg~Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg~Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg~Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period."
196761|NCT01202071|P4|Participant Flow|Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
196849|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196915|NCT01201317|B3|Baseline|Placebo|tablets, once daily in the morning
196762|NCT01202071|P3|Participant Flow|Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
196763|NCT01202071|P2|Participant Flow|Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
196764|NCT01202071|P1|Participant Flow|Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
196765|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
196766|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
196767|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
196768|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
196769|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
196770|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
196771|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
196772|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
196773|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
196774|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
196775|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
196776|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
196777|NCT01202071|E4|Reported Event|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
196778|NCT01202071|E3|Reported Event|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
196779|NCT01202071|E2|Reported Event|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
196924|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
196780|NCT01202071|E1|Reported Event|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
196781|NCT01201967|B3|Baseline|Total|Total of all reporting groups
196782|NCT01201967|B2|Baseline|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
196783|NCT01201967|B1|Baseline|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196784|NCT01201967|P2|Participant Flow|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
196785|NCT01201967|P1|Participant Flow|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196786|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196787|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196788|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196789|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196790|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196791|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196792|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
196793|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196794|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196795|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196796|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
196797|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196798|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196799|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196800|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
196801|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196802|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
225908|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
196803|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196804|NCT01201967|E2|Reported Event|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
196805|NCT01201967|E1|Reported Event|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
196806|NCT01201915|B4|Baseline|Total|Total of all reporting groups
196807|NCT01201915|B3|Baseline|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
196808|NCT01201915|B2|Baseline|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196809|NCT01201915|B1|Baseline|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196810|NCT01201915|P3|Participant Flow|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
196811|NCT01201915|P2|Participant Flow|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196812|NCT01201915|P1|Participant Flow|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196813|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
196814|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196815|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196816|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
196817|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196818|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196819|NCT01201915|E3|Reported Event|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
196820|NCT01201915|E2|Reported Event|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196821|NCT01201915|E1|Reported Event|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
196822|NCT01201811|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196823|NCT01201811|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196824|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196825|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196826|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196827|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196828|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196829|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196830|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196831|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196832|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196833|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196834|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196835|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196836|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196837|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196838|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196839|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196840|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196841|NCT01201811|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
196842|NCT01201798|B3|Baseline|Total|Total of all reporting groups
196843|NCT01201798|B2|Baseline|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196844|NCT01201798|B1|Baseline|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196916|NCT01201317|B2|Baseline|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196851|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196852|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196853|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196854|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196855|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196856|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196857|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196858|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196859|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196860|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196861|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196862|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196863|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196864|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196865|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196866|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196867|NCT01201798|E2|Reported Event|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
196868|NCT01201798|E1|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
196869|NCT01201785|B1|Baseline|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
196870|NCT01201785|P1|Participant Flow|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
196871|NCT01201785|O1|Outcome|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
196872|NCT01201785|E1|Reported Event|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
196873|NCT01201772|B4|Baseline|Total|Total of all reporting groups
196874|NCT01201772|B3|Baseline|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
196875|NCT01201772|B2|Baseline|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
196876|NCT01201772|B1|Baseline|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
196877|NCT01201772|P3|Participant Flow|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablet
196878|NCT01201772|P2|Participant Flow|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablet
196879|NCT01201772|P1|Participant Flow|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
196880|NCT01201772|O3|Outcome|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
196881|NCT01201772|O2|Outcome|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
196882|NCT01201772|O1|Outcome|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
196883|NCT01201772|E1|Reported Event|All Study Participants|All participants who received prasugrel
196884|NCT01201759|B3|Baseline|Total|Total of all reporting groups
196885|NCT01201759|B2|Baseline|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
196886|NCT01201759|B1|Baseline|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
196917|NCT01201317|B1|Baseline|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196918|NCT01201317|P3|Participant Flow|Placebo|tablets, once daily in the morning
196919|NCT01201317|P2|Participant Flow|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196920|NCT01201317|P1|Participant Flow|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196887|NCT01201759|P2|Participant Flow|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
196888|NCT01201759|P1|Participant Flow|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
196889|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
196890|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
196891|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
196892|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
196893|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
196894|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
196895|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
196896|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
196897|NCT01201759|E2|Reported Event|Salsalate 2gr BID|Salsalate 2grams twice a day for 30 days.
196898|NCT01201759|E1|Reported Event|Placebo 2gr BID|Placebo twice a day for 30 days.
196899|NCT01201486|B1|Baseline|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
196900|NCT01201486|P1|Participant Flow|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
196901|NCT01201486|O1|Outcome|Pregnant Women|Pregnant females in the 2nd trimester.
196902|NCT01201486|E1|Reported Event|Pregnant Women|Pregnant females in the 2nd trimester.
196903|NCT01201343|B1|Baseline|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196904|NCT01201343|P1|Participant Flow|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196905|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196906|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196907|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196908|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196909|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196910|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196911|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196912|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196913|NCT01201343|E1|Reported Event|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
196925|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196926|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196927|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
196928|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196929|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196930|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
196931|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196932|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196933|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
196934|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196935|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196936|NCT01201317|E3|Reported Event|Placebo|tablets, once daily in the morning
196937|NCT01201317|E2|Reported Event|AZD2423 20 mg|tablets, 20 mg once daily in the morning
196938|NCT01201317|E1|Reported Event|AZD2423 150 mg|tablets, 150 mg once daily in the morning
196939|NCT01201265|B1|Baseline|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196940|NCT01201265|P1|Participant Flow|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196941|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196942|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196943|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196944|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196945|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196946|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196947|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196948|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196949|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196950|NCT01201265|E1|Reported Event|All Particiapants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
196951|NCT01200992|B3|Baseline|Total|Total of all reporting groups
196952|NCT01200992|B2|Baseline|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
196953|NCT01200992|B1|Baseline|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
196954|NCT01200992|P2|Participant Flow|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
196955|NCT01200992|P1|Participant Flow|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
196956|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
196957|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
196958|NCT01200992|E2|Reported Event|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
196959|NCT01200992|E1|Reported Event|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
196960|NCT01200875|B1|Baseline|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
196961|NCT01200875|P1|Participant Flow|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
196962|NCT01200875|O1|Outcome|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
196963|NCT01200875|E1|Reported Event|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
196964|NCT01200810|B3|Baseline|Total|Total of all reporting groups
196965|NCT01200810|B2|Baseline|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196966|NCT01200810|B1|Baseline|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196967|NCT01200810|P2|Participant Flow|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196968|NCT01200810|P1|Participant Flow|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196969|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196970|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196971|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196972|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196973|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196974|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196975|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196995|NCT01200758|B1|Baseline|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197877|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
196976|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196977|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196978|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196979|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196980|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196981|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196982|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196983|NCT01200810|E2|Reported Event|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196984|NCT01200810|E1|Reported Event|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
196985|NCT01200797|B1|Baseline|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196986|NCT01200797|P1|Participant Flow|Treatment (SJG-136)|SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196987|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196988|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196989|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196990|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196991|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196992|NCT01200797|E1|Reported Event|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
196993|NCT01200758|B3|Baseline|Total|Total of all reporting groups
196994|NCT01200758|B2|Baseline|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
196996|NCT01200758|P4|Participant Flow|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
196997|NCT01200758|P3|Participant Flow|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
196998|NCT01200758|P2|Participant Flow|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
196999|NCT01200758|P1|Participant Flow|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 milligrams per square meter [mg/m^2]; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197000|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197001|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197002|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197003|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197004|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197005|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197006|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197007|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197008|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197009|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197010|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197011|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197012|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197013|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197014|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197878|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197015|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197016|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197017|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197018|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197019|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197020|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197021|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197022|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197023|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197024|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197025|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197026|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197027|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197028|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197029|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197030|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197031|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197032|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197033|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197082|NCT01200498|B1|Baseline|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
197034|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197035|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197036|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197037|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197038|NCT01200758|E2|Reported Event|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
197039|NCT01200758|E1|Reported Event|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
197040|NCT01200602|B3|Baseline|Total|Total of all reporting groups
197041|NCT01200602|B2|Baseline|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197042|NCT01200602|B1|Baseline|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197043|NCT01200602|P2|Participant Flow|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197044|NCT01200602|P1|Participant Flow|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197045|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197046|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197047|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197048|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197049|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197050|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197051|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197052|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197053|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197054|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197055|NCT01200602|E2|Reported Event|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
197056|NCT01200602|E1|Reported Event|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
197057|NCT01200524|B4|Baseline|Total|Total of all reporting groups
197058|NCT01200524|B3|Baseline|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197059|NCT01200524|B2|Baseline|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197060|NCT01200524|B1|Baseline|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197061|NCT01200524|P3|Participant Flow|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197062|NCT01200524|P2|Participant Flow|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197063|NCT01200524|P1|Participant Flow|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197064|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197065|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197066|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197067|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197068|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197069|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197070|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197071|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197072|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197073|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197074|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197075|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197076|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197077|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197078|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197079|NCT01200524|E3|Reported Event|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
197080|NCT01200524|E2|Reported Event|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
197081|NCT01200524|E1|Reported Event|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
197083|NCT01200498|P1|Participant Flow|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
197084|NCT01200498|O1|Outcome|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
197085|NCT01200498|E1|Reported Event|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
197086|NCT01200433|B3|Baseline|Total|Total of all reporting groups
197087|NCT01200433|B2|Baseline|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197088|NCT01200433|B1|Baseline|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197089|NCT01200433|P2|Participant Flow|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197090|NCT01200433|P1|Participant Flow|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197091|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197092|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197093|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197094|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197095|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197096|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197097|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197098|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197099|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197100|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197101|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197102|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197103|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197104|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197105|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197106|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197107|NCT01200433|E2|Reported Event|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
197108|NCT01200433|E1|Reported Event|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
197109|NCT01200368|B4|Baseline|Total|Total of all reporting groups
197110|NCT01200368|B3|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
225909|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
197111|NCT01200368|B2|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197112|NCT01200368|B1|Baseline|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197113|NCT01200368|P3|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197114|NCT01200368|P2|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197115|NCT01200368|P1|Participant Flow|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197116|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197117|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197118|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197119|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197120|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197121|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197122|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197123|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197124|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197278|NCT01199926|B1|Baseline|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
197125|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197126|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197127|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197128|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197129|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197130|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197131|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197132|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197133|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197134|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197135|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197136|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197137|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197138|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197279|NCT01199926|P2|Participant Flow|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
197139|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197140|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197141|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197142|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197143|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197144|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197145|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197146|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197147|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197148|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197149|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197150|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197151|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197152|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197436|NCT01198769|P1|Participant Flow|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197153|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197154|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197155|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197156|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197157|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197158|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197159|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197160|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197161|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
197162|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197163|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197164|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197165|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197166|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
197189|NCT01200069|B1|Baseline|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
197280|NCT01199926|P1|Participant Flow|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
197167|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
197168|NCT01200368|E10|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
197169|NCT01200368|E9|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
197170|NCT01200368|E8|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
197171|NCT01200368|E7|Reported Event|13vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
197172|NCT01200368|E6|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
197173|NCT01200368|E5|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
197174|NCT01200368|E4|Reported Event|13vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
197175|NCT01200368|E3|Reported Event|DTaP (Catch-up 7vPnC) - Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
197176|NCT01200368|E2|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
197177|NCT01200368|E1|Reported Event|13vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
197178|NCT01200342|B1|Baseline|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
197179|NCT01200342|P1|Participant Flow|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
197180|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
197181|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
197182|NCT01200342|E1|Reported Event|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
197183|NCT01200160|B1|Baseline|Lipid Abnormalities|
197184|NCT01200160|P1|Participant Flow|Lipid Abnormalities|"No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.~This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject’s was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.~Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."
197185|NCT01200160|O1|Outcome|HDL-Cholesterol|
197186|NCT01200160|E1|Reported Event|Lipid Abnormalities|Those with the condition and exposed to the study drug
197187|NCT01200069|B3|Baseline|Total|Total of all reporting groups
197188|NCT01200069|B2|Baseline|Ibuprofen|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
197276|NCT01199926|B3|Baseline|Total|Total of all reporting groups
197190|NCT01200069|P2|Participant Flow|Ibuprofen|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
197191|NCT01200069|P1|Participant Flow|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
197192|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|
197193|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|
197194|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|
197195|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|
197196|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|myalgia
197197|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|
197198|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
197199|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
197200|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|
197201|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|
197202|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|
197203|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|
197204|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|myalgia
197205|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|
197206|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
197207|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
197208|NCT01200069|O8|Outcome|Pain Score Ibuprofen 48 Hours After Treatment 1|
197209|NCT01200069|O7|Outcome|Pain Score Sugar Water 48 Hours After Treatment 1|
197210|NCT01200069|O6|Outcome|Pain Score Ibuprofen 24 Hours After Treatment #1|
197211|NCT01200069|O5|Outcome|Pain Score Sugar Water 24 Hours After Treatment #1|
197212|NCT01200069|O4|Outcome|Pain Score Ibuprofen 6 Hours After Treatment #1|
197213|NCT01200069|O3|Outcome|Pain Score After Sugar Water 6 Hours After Treatment #1|
197214|NCT01200069|O2|Outcome|Pain Score Ibuprofen One Hour After Treatment #1|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
197215|NCT01200069|O1|Outcome|Pain Score Sugar Water-one Hour After Treatment 1|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1"
197216|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|
197217|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|
197218|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|
197219|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|
197220|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|myalgia
197221|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|
197222|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
197223|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
197224|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 2|
197225|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 2|
197226|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|
197227|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|
197228|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|myalgia
197229|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|
197230|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
197231|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
197232|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 1|subject reported myalgia 48 hours after treatment day 1
197233|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Procedure 1|subject reported myalgia 48 hours after procedure 1
197234|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment 1|subject reported myalgia 24 hours after procedure 1
197235|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #1|subject reported myalgia 24 hours after completion of procedure 1
197236|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #1|subject reported myalgia 6 hours after treatment 1
197237|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #1|6 hours after completion of treatment # 1,
197277|NCT01199926|B2|Baseline|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
197238|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #1|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~subject report of myalgia one hour after completion of procedure number 1"
197239|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment #1|500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
197240|NCT01200069|E2|Reported Event|Ibuprofen|"300mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
197241|NCT01200069|E1|Reported Event|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
197242|NCT01199965|B3|Baseline|Total|Total of all reporting groups
197243|NCT01199965|B2|Baseline|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
197244|NCT01199965|B1|Baseline|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
197245|NCT01199965|P2|Participant Flow|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
197246|NCT01199965|P1|Participant Flow|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
197247|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at Visit 2 or 3.
197248|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at Visit 2 or 3.
197249|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at Visit 2 or 3.
197250|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at Visit 2 or 3.
197251|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
197252|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
197253|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
197254|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
197255|NCT01199965|E4|Reported Event|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
197256|NCT01199965|E3|Reported Event|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
197257|NCT01199965|E2|Reported Event|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
197258|NCT01199965|E1|Reported Event|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
197259|NCT01199939|B1|Baseline|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197260|NCT01199939|P1|Participant Flow|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197261|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197262|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197263|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197264|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197265|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197266|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197267|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197268|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197269|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197270|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197271|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197272|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197273|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197274|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197275|NCT01199939|E1|Reported Event|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
197281|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
197282|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
197283|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
197284|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
197285|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
197286|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
197287|NCT01199926|E2|Reported Event|Placebo|Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
197288|NCT01199926|E1|Reported Event|Vitamin D|Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention.
197289|NCT01199861|B3|Baseline|Total|Total of all reporting groups
197290|NCT01199861|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197291|NCT01199861|B1|Baseline|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197292|NCT01199861|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197293|NCT01199861|P1|Participant Flow|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197294|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197295|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197296|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197297|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197298|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197299|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197300|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197301|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197302|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197303|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197304|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197305|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197306|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197307|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197308|NCT01199861|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197309|NCT01199861|E1|Reported Event|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
197310|NCT01199744|B1|Baseline|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197311|NCT01199744|P1|Participant Flow|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197312|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197437|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197313|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197314|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197315|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197316|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197317|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197318|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197319|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197320|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197321|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197322|NCT01199744|E1|Reported Event|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
197323|NCT01199705|B1|Baseline|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
197324|NCT01199705|P1|Participant Flow|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
197325|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
197326|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197327|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
197328|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197329|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
197330|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
197331|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
197332|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
197333|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
197334|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
197335|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197336|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
197337|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
197338|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
197339|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
197340|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197341|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
197342|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
197343|NCT01199705|O1|Outcome|IVIG Treatment|Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197344|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
197438|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197345|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
197346|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
197347|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
197348|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
197349|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
197350|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
197351|NCT01199705|E2|Reported Event|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
197352|NCT01199705|E1|Reported Event|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
197353|NCT01199601|B3|Baseline|Total|Total of all reporting groups
197354|NCT01199601|B2|Baseline|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197355|NCT01199601|B1|Baseline|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling."
197356|NCT01199601|P2|Participant Flow|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197357|NCT01199601|P1|Participant Flow|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study."
197358|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197359|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
197360|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197361|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
197362|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197363|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
197364|NCT01199601|E2|Reported Event|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
197365|NCT01199601|E1|Reported Event|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
197366|NCT01199471|B1|Baseline|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197367|NCT01199471|P1|Participant Flow|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197393|NCT01199042|P1|Participant Flow|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
197368|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197369|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197370|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197371|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197372|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197373|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
197374|NCT01199471|E1|Reported Event|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
197375|NCT01199237|B3|Baseline|Total|Total of all reporting groups
197376|NCT01199237|B2|Baseline|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197377|NCT01199237|B1|Baseline|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197378|NCT01199237|P2|Participant Flow|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197379|NCT01199237|P1|Participant Flow|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197380|NCT01199237|O2|Outcome|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197381|NCT01199237|O1|Outcome|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
197382|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197383|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197384|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197385|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197386|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197387|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197388|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197389|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197390|NCT01199237|E2|Reported Event|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197391|NCT01199237|E1|Reported Event|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
197392|NCT01199042|B1|Baseline|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
197394|NCT01199042|O1|Outcome|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
197395|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|"Positive airway pressure device~BiPAP autoSV Advanced: The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night."
197396|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|Over the 90-day home treatment period, the Auto-Servo Ventilation (ASV) device consistently treated obstructive and central Sleep Disordered Breathing (SDB) events.
197397|NCT01199042|O3|Outcome|BiPAP autoSV Apnea-Hypopnea Index|The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
197398|NCT01199042|O2|Outcome|Continuous Positive Airway Pressure Apnea-Hypopnea Index|The CPAP machine was used to determine the Apnea-Hypopnea Index.
197399|NCT01199042|O1|Outcome|Diagnostic Apnea-Hypopnea Index|Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured
197400|NCT01199042|E1|Reported Event|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days.
197401|NCT01198977|B3|Baseline|Total|Total of all reporting groups
197402|NCT01198977|B2|Baseline|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
197403|NCT01198977|B1|Baseline|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197404|NCT01198977|P2|Participant Flow|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
197405|NCT01198977|P1|Participant Flow|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197406|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
197407|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197408|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
197409|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197410|NCT01198977|O2|Outcome|Education Counseling|"Self-directed physical activity information and instructional video~Informational video: Mailed video of Physical activity programs"
197411|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197412|NCT01198977|E2|Reported Event|Education Counseling|"Exercise information and instructional video (Control)~Informational video: Mailed video of exercise programs"
197413|NCT01198977|E1|Reported Event|Telephone Counseling|"Telephone based counseling and instructional video (Intervention)~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
197414|NCT01198873|B3|Baseline|Total|Total of all reporting groups
197415|NCT01198873|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197416|NCT01198873|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197417|NCT01198873|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197418|NCT01198873|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197419|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197420|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197421|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197422|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197423|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197424|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197425|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197426|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197427|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197428|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197429|NCT01198873|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
197430|NCT01198873|E1|Reported Event|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
197431|NCT01198795|B1|Baseline|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
197432|NCT01198795|P1|Participant Flow|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
197433|NCT01198795|O1|Outcome|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
197434|NCT01198795|E1|Reported Event|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
197435|NCT01198769|B1|Baseline|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197439|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197440|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197441|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197442|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197443|NCT01198769|E1|Reported Event|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
197444|NCT01198756|B5|Baseline|Total|Total of all reporting groups
197445|NCT01198756|B4|Baseline|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197446|NCT01198756|B3|Baseline|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197447|NCT01198756|B2|Baseline|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197448|NCT01198756|B1|Baseline|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197449|NCT01198756|P4|Participant Flow|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197450|NCT01198756|P3|Participant Flow|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197451|NCT01198756|P2|Participant Flow|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197452|NCT01198756|P1|Participant Flow|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197453|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197454|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197455|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197456|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197457|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197458|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197459|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197460|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197461|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197462|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197463|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197464|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197465|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197466|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197467|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197468|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197469|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197470|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197471|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197472|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197473|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197474|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197475|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197476|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197477|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197478|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197479|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197480|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197481|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197482|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197483|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197484|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197549|NCT01198691|B1|Baseline|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197485|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197486|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197487|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197488|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197489|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197490|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197491|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197492|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197493|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197494|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197495|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197496|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197497|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197498|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197499|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197500|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197501|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197502|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197503|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197504|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197505|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197879|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197506|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197507|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197508|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197509|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197510|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197511|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197512|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197513|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197514|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197515|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197516|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197517|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197518|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197519|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197520|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197521|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197522|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197523|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197524|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197525|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197526|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197656|NCT01198366|P6|Participant Flow|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197527|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197528|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197529|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197530|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197531|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197532|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197533|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197534|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197535|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197536|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197537|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197538|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197539|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197540|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197541|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197542|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197543|NCT01198756|E4|Reported Event|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
197544|NCT01198756|E3|Reported Event|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197545|NCT01198756|E2|Reported Event|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197546|NCT01198756|E1|Reported Event|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
197547|NCT01198691|B3|Baseline|Total|Total of all reporting groups
197548|NCT01198691|B2|Baseline|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197718|NCT01197911|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197550|NCT01198691|P2|Participant Flow|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197551|NCT01198691|P1|Participant Flow|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197552|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197553|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197554|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197555|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197556|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197557|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197558|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197559|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197560|NCT01198691|E2|Reported Event|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
197561|NCT01198691|E1|Reported Event|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
197562|NCT01198600|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
197563|NCT01198600|P4|Participant Flow|Phase 3: Lotrafilcon B Replacement Replacement|Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
197564|NCT01198600|P3|Participant Flow|Phase 2: Lotrafilcon B Replacement|Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
197565|NCT01198600|P2|Participant Flow|Phase 1: Habitual Replacement, Then Habitual no Replacement|Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
197566|NCT01198600|P1|Participant Flow|Phase 1: Habitual no Replacement, Then Habitual Replacement|Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28.
197567|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197568|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197569|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197570|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197571|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197572|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197573|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197574|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197575|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197719|NCT01197911|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197576|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197577|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2."
197578|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197579|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197580|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197581|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197582|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197583|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
197584|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
197585|NCT01198600|E2|Reported Event|Lotrafilcon B Contact Lens|Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
197586|NCT01198600|E1|Reported Event|Habitual Contact Lens|Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.
197587|NCT01198574|B5|Baseline|Total|Total of all reporting groups
197588|NCT01198574|B4|Baseline|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
197589|NCT01198574|B3|Baseline|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
197590|NCT01198574|B2|Baseline|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
197591|NCT01198574|B1|Baseline|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
197592|NCT01198574|P4|Participant Flow|Placebo Group|Placebo group received 2.5 mg folic acid weekly
197593|NCT01198574|P3|Participant Flow|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
197594|NCT01198574|P2|Participant Flow|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
197595|NCT01198574|P1|Participant Flow|Iron Group|Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
197596|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
197597|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
197598|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
197599|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
197600|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
197601|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
197602|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
197603|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
197604|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
197605|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
197606|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
197607|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
197608|NCT01198574|E4|Reported Event|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
197609|NCT01198574|E3|Reported Event|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
197610|NCT01198574|E2|Reported Event|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
197611|NCT01198574|E1|Reported Event|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
197629|NCT01198509|P5|Participant Flow|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
197720|NCT01197911|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
225910|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
197612|NCT01198548|B1|Baseline|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197613|NCT01198548|P1|Participant Flow|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197614|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197615|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197616|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197617|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197618|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197619|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197620|NCT01198548|E1|Reported Event|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
197621|NCT01198509|B7|Baseline|Total|Total of all reporting groups
197622|NCT01198509|B6|Baseline|Healthy Volunteers|Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
197623|NCT01198509|B5|Baseline|Psoriatic Arthritis (PsA)|Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
197624|NCT01198509|B4|Baseline|Early RA Cross-sectional Cohort|Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
197625|NCT01198509|B3|Baseline|Rheumatoid Arthritis (RA) Randomized to no Treatment|Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
197626|NCT01198509|B2|Baseline|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
197627|NCT01198509|B1|Baseline|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
197628|NCT01198509|P6|Participant Flow|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
197630|NCT01198509|P4|Participant Flow|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
197631|NCT01198509|P3|Participant Flow|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
197632|NCT01198509|P2|Participant Flow|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks~N=10 (actual)"
197633|NCT01198509|P1|Participant Flow|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months~N=5 (actual)"
197634|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
197635|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
197636|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
197637|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
197638|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
197639|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
197640|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
197641|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
197642|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
197643|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment, followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
197644|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
197645|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
197646|NCT01198509|E3|Reported Event|RA, PsA, Healthy|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients."
197647|NCT01198509|E2|Reported Event|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
197648|NCT01198509|E1|Reported Event|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
197649|NCT01198366|B7|Baseline|Total|Total of all reporting groups
197650|NCT01198366|B6|Baseline|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197651|NCT01198366|B5|Baseline|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197652|NCT01198366|B4|Baseline|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197653|NCT01198366|B3|Baseline|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197654|NCT01198366|B2|Baseline|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197655|NCT01198366|B1|Baseline|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197875|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197657|NCT01198366|P5|Participant Flow|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197658|NCT01198366|P4|Participant Flow|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197659|NCT01198366|P3|Participant Flow|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197660|NCT01198366|P2|Participant Flow|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197661|NCT01198366|P1|Participant Flow|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197662|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197663|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197664|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197665|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197666|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197667|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197668|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197669|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197670|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197671|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197672|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197673|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197674|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197675|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197676|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197677|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197678|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197679|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197680|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197681|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197876|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197682|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197683|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197684|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197685|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197686|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
197687|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197688|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197689|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197690|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
197691|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
197692|NCT01198366|E6|Reported Event|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.~Placebo"
197693|NCT01198366|E5|Reported Event|Expanded Safety Phase - Group 5|Subjects received 3 doses of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.
197694|NCT01198366|E4|Reported Event|Dose Finding - Group 4|Subjects received two doses of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.
197695|NCT01198366|E3|Reported Event|Dose Finding - Group 3|Subjects received two doses of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.
197696|NCT01198366|E2|Reported Event|Dose Finding - Group 2|Subjects received two doses of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.
197697|NCT01198366|E1|Reported Event|Dose Finding - Group 1|Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
197698|NCT01198327|B1|Baseline|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
197699|NCT01198327|P1|Participant Flow|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
197700|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
197701|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for central retinal vein occlusion.
197702|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
197703|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for Central retinal vein occlusion.
197704|NCT01198327|O1|Outcome|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
197705|NCT01198327|E1|Reported Event|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
197706|NCT01198275|B3|Baseline|Total|Total of all reporting groups
197707|NCT01198275|B2|Baseline|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
197708|NCT01198275|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
197709|NCT01198275|P2|Participant Flow|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
197710|NCT01198275|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
197711|NCT01198275|O2|Outcome|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
197712|NCT01198275|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
197713|NCT01198275|E2|Reported Event|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
197714|NCT01198275|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
197715|NCT01197911|B4|Baseline|Total|Total of all reporting groups
197716|NCT01197911|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197717|NCT01197911|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
225911|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
197721|NCT01197911|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197722|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197723|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197724|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197725|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197726|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197727|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197728|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197729|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197730|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197731|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197732|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197733|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197734|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197735|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197736|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197737|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197738|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197739|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197740|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197741|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197742|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197743|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197744|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197745|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197746|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197747|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197748|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197749|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197750|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197751|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197752|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197753|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197754|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197755|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197756|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197757|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197758|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197759|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197760|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197761|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197762|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197763|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197764|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197765|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197766|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197767|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197768|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197769|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197770|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197771|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197772|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197773|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197774|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197775|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197776|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197777|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197778|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197779|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197780|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197781|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197782|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197783|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197784|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197785|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197786|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197787|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197788|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197789|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197790|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197791|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197792|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197793|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 mcg tablet
197794|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197795|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197796|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197797|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197798|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197799|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197800|NCT01197911|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197801|NCT01197911|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
197802|NCT01197911|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
197803|NCT01197898|B3|Baseline|Total|Total of all reporting groups
197804|NCT01197898|B2|Baseline|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
197805|NCT01197898|B1|Baseline|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
197806|NCT01197898|P2|Participant Flow|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
197807|NCT01197898|P1|Participant Flow|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
225912|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
197808|NCT01197898|O2|Outcome|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
197809|NCT01197898|O1|Outcome|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
197810|NCT01197898|E2|Reported Event|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
197811|NCT01197898|E1|Reported Event|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
197812|NCT01197833|B4|Baseline|Total|Total of all reporting groups
197813|NCT01197833|B3|Baseline|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
197814|NCT01197833|B2|Baseline|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
197815|NCT01197833|B1|Baseline|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
197816|NCT01197833|P3|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
197817|NCT01197833|P2|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
197818|NCT01197833|P1|Participant Flow|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
197819|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
197820|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
197821|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
197822|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
197823|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
197824|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
197825|NCT01197833|E3|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
197826|NCT01197833|E2|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
197827|NCT01197833|E1|Reported Event|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
197828|NCT01197794|B8|Baseline|Total|Total of all reporting groups
197829|NCT01197794|B7|Baseline|Placebo|Placebo
197830|NCT01197794|B6|Baseline|AZD1981 10 mg|AZD1981 10 mg twice daily
197831|NCT01197794|B5|Baseline|AZD1981 40 mg|AZD1981 40 mg twice daily
197832|NCT01197794|B4|Baseline|AZD1981 80 mg|AZD1981 80 mg once daily
197833|NCT01197794|B3|Baseline|AZD1981 100 mg|AZD1981 100 mg twice daily
197834|NCT01197794|B2|Baseline|AZD1981 200 mg|AZD1981 200 mg once daily
197835|NCT01197794|B1|Baseline|AZD1981 400 mg|AZD1981 400 mg twice daily
197836|NCT01197794|P7|Participant Flow|Placebo|Placebo
197837|NCT01197794|P6|Participant Flow|AZD1981 10 mg|AZD1981 10 mg twice daily
197838|NCT01197794|P5|Participant Flow|AZD1981 40 mg|AZD1981 40 mg twice daily
197839|NCT01197794|P4|Participant Flow|AZD1981 80 mg|AZD1981 80 mg once daily
197840|NCT01197794|P3|Participant Flow|AZD1981 100 mg|AZD1981 100 mg twice daily
197841|NCT01197794|P2|Participant Flow|AZD1981 200 mg|AZD1981 200 mg once daily
197842|NCT01197794|P1|Participant Flow|AZD1981 400 mg|AZD1981 400 mg twice daily
197843|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197844|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197845|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197846|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197847|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197848|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197849|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197850|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197851|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197852|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197853|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197854|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197855|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197856|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197857|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197858|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197859|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197860|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197861|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197862|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197863|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197864|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197865|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197866|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197867|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197868|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197869|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197870|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197871|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197872|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197873|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197874|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197880|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197881|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197882|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197883|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197884|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197885|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197886|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197887|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197888|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197889|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197890|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197891|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197892|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197893|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197894|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197895|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197896|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197897|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197898|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197899|NCT01197794|O7|Outcome|Arm 7-Placebo|Placebo
197900|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197901|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197902|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197903|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197904|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197905|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197906|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
197907|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
197908|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
197909|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
197910|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
197911|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
197912|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
197913|NCT01197794|E7|Reported Event|Placebo|Placebo
197914|NCT01197794|E6|Reported Event|AZD1981 10 mg|AZD1981 10 mg twice daily
197915|NCT01197794|E5|Reported Event|AZD1981 40 mg|AZD1981 40 mg twice daily
197916|NCT01197794|E4|Reported Event|AZD1981 80 mg|AZD1981 80 mg once daily
197917|NCT01197794|E3|Reported Event|AZD1981 100 mg|AZD1981 100 mg twice daily
197918|NCT01197794|E2|Reported Event|AZD1981 200 mg|AZD1981 200 mg once daily
197919|NCT01197794|E1|Reported Event|AZD1981 400 mg|AZD1981 400 mg twice daily
197920|NCT01197755|B4|Baseline|Total|Total of all reporting groups
197921|NCT01197755|B3|Baseline|PLACEBO PO|Dosing Group C
197922|NCT01197755|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197923|NCT01197755|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
197924|NCT01197755|P3|Participant Flow|PLACEBO PO|Dosing Group C
197925|NCT01197755|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197926|NCT01197755|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
197927|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197928|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197929|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197930|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197931|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197932|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197933|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197934|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197935|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197936|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197937|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197938|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197939|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197940|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197941|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197942|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197943|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197944|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197945|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197946|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197947|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197948|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197949|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197950|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197951|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197952|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197953|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197954|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197955|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197956|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197957|NCT01197755|O2|Outcome|Dosing Group A and B Combined PO|Fostamatinib 100 mg BID (combined)
197958|NCT01197755|O1|Outcome|PLACEBO PO|Dosing Group C
197959|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
197960|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197961|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
197962|NCT01197755|E3|Reported Event|PLACEBO PO|Dosing Group C
197963|NCT01197755|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197964|NCT01197755|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
197965|NCT01197560|B3|Baseline|Total|Total of all reporting groups
197966|NCT01197560|B2|Baseline|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197967|NCT01197560|B1|Baseline|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197968|NCT01197560|P2|Participant Flow|Investigator's Choice (Control Arm)|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the participant's request and at the investigators' discretion at the same doses mentioned."
197969|NCT01197560|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197970|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197971|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197972|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197973|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197974|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197975|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
198027|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198028|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198029|NCT01197534|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
197976|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197977|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197978|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197979|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197980|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197981|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197982|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197983|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197984|NCT01197560|O2|Outcome|Investigator's Choice|"Investigator’s Choice Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197985|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
198030|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO (Combined)|Dosing Group A and B combined
198031|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198032|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198033|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
225913|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
197986|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197987|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197988|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
197989|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
197990|NCT01197560|E2|Reported Event|Investigator's Choice|"One of the following:~Gemcitabine, Oxaliplatin, Rituximab, or Etoposide~Gemcitabine: Suggested starting doses and regimens for Gemcitabine are 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles~Oxaliplatin: Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles~Rituximab: Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide: Suggested starting doses for Etoposide are:~100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles"
197991|NCT01197560|E1|Reported Event|Lenalidomide|Lenalidomide: Lenalidomide 25 mg orally for 21 out of every 28 day cycle until progressive disease. For participants with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg (maximum dose was 15 mg lenalidomide).
197992|NCT01197534|B4|Baseline|Total|Total of all reporting groups
197993|NCT01197534|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
197994|NCT01197534|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197995|NCT01197534|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
197996|NCT01197534|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
197997|NCT01197534|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
197998|NCT01197534|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
197999|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198000|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198001|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198002|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198003|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198004|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198005|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198006|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198007|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198008|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198009|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198010|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198011|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198012|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198013|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198014|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198015|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198016|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198017|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198018|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198019|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198020|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198021|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198022|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198023|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198024|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198025|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198026|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198034|NCT01197534|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
198035|NCT01197534|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
198036|NCT01197534|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
198037|NCT01197534|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
198038|NCT01197521|B4|Baseline|Total|Total of all reporting groups
198039|NCT01197521|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198040|NCT01197521|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198041|NCT01197521|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
198042|NCT01197521|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198043|NCT01197521|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198044|NCT01197521|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
198045|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198046|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198047|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198048|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198049|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198050|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198051|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198052|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198053|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198054|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198055|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198056|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198057|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198058|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198059|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198060|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198061|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198062|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198063|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198064|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198065|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198066|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198067|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198068|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198069|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198070|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198071|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198072|NCT01197521|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198073|NCT01197521|O1|Outcome|FOSTA 100 MG BID (Combined)|Dosing Group A and B combined
198074|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198075|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198076|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198077|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
198078|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
198079|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
198080|NCT01197521|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
198081|NCT01197521|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
198082|NCT01197521|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
198083|NCT01197521|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
198084|NCT01197508|B5|Baseline|Total|Total of all reporting groups
198085|NCT01197508|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198086|NCT01197508|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198087|NCT01197508|B2|Baseline|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198088|NCT01197508|B1|Baseline|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198089|NCT01197508|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198090|NCT01197508|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198091|NCT01197508|P2|Participant Flow|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198092|NCT01197508|P1|Participant Flow|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198093|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198094|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198095|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198096|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198097|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198098|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198099|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198100|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198101|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198102|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198103|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198104|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198105|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198106|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198107|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198108|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198109|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198110|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198111|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198112|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198113|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198114|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198115|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198116|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198117|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198118|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198119|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198120|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198121|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198122|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198123|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198124|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198125|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198126|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198127|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198128|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198129|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198130|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198131|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198132|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198133|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198134|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198135|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198136|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198137|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198138|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198139|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198140|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198141|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198142|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198143|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198144|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198145|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198146|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198147|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198148|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198149|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198150|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198151|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198152|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198153|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198154|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198155|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198156|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198157|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198158|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198159|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198160|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198161|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198162|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198163|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198164|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198165|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198166|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198167|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198168|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198169|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198170|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198171|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198172|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198173|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198174|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198175|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198176|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198177|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
198178|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198179|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198180|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198181|NCT01197508|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
198182|NCT01197508|E3|Reported Event|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
198183|NCT01197508|E2|Reported Event|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
198184|NCT01197508|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
198185|NCT01197495|B3|Baseline|Total|Total of all reporting groups
198186|NCT01197495|B2|Baseline|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
198187|NCT01197495|B1|Baseline|Treatment|Juvederm(R) Ultra XC Injectable Gel
198188|NCT01197495|P2|Participant Flow|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
198189|NCT01197495|P1|Participant Flow|Treatment|Juvederm(R) Ultra XC Injectable Gel
198190|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
198191|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
198192|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
198193|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
198194|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
198195|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
198196|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
198197|NCT01197495|E2|Reported Event|Onset After Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
198198|NCT01197495|E1|Reported Event|Onset Prior to Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
198199|NCT01197417|B3|Baseline|Total|Total of all reporting groups
198200|NCT01197417|B2|Baseline|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198201|NCT01197417|B1|Baseline|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198202|NCT01197417|P2|Participant Flow|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198203|NCT01197417|P1|Participant Flow|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198204|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198205|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198206|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198207|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198208|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198209|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198210|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198211|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198212|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198213|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198214|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198215|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198216|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
198217|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
198218|NCT01197417|E2|Reported Event|Placebo Group|Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
198219|NCT01197417|E1|Reported Event|Magnesium Group|Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
198220|NCT01197326|B3|Baseline|Total|Total of all reporting groups
198221|NCT01197326|B2|Baseline|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198222|NCT01197326|B1|Baseline|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
199133|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
198223|NCT01197326|P2|Participant Flow|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198224|NCT01197326|P1|Participant Flow|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198225|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198226|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198227|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198228|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
198229|NCT01197326|E2|Reported Event|Patients Who Triggered MET/RRT Calls After the Use of MP5|Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor
198230|NCT01197326|E1|Reported Event|Patients Who Triggered MET/RRT Calls Prior to the Use of MP5|Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor
198231|NCT01196988|B5|Baseline|Total|Total of all reporting groups
198232|NCT01196988|B4|Baseline|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198233|NCT01196988|B3|Baseline|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198234|NCT01196988|B2|Baseline|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198235|NCT01196988|B1|Baseline|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198236|NCT01196988|P4|Participant Flow|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198237|NCT01196988|P3|Participant Flow|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198238|NCT01196988|P2|Participant Flow|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198239|NCT01196988|P1|Participant Flow|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198240|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198345|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198241|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198242|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198243|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198244|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198245|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198246|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198247|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198248|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198249|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198250|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198251|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198252|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198253|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198254|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198255|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198256|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198257|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198258|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198259|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198260|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198261|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198262|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198263|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198264|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198265|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198266|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198267|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198268|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198269|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198270|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198271|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198272|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198273|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198274|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198275|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198276|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198277|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198278|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198279|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198280|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198281|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198282|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198283|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198284|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198285|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198286|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198287|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198288|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198289|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198290|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198291|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198292|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198293|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198294|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198295|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198296|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198297|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198298|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198299|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198300|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198301|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198302|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198303|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198304|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198305|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198306|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198307|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198308|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198309|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198310|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198311|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198312|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198313|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198314|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198315|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198316|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198317|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198318|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198319|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198320|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198321|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198322|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198323|NCT01196988|E4|Reported Event|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198324|NCT01196988|E3|Reported Event|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198325|NCT01196988|E2|Reported Event|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198326|NCT01196988|E1|Reported Event|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
198327|NCT01196975|B6|Baseline|Total|Total of all reporting groups
198328|NCT01196975|B5|Baseline|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198329|NCT01196975|B4|Baseline|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198330|NCT01196975|B3|Baseline|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198331|NCT01196975|B2|Baseline|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198332|NCT01196975|B1|Baseline|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198333|NCT01196975|P5|Participant Flow|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198334|NCT01196975|P4|Participant Flow|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198335|NCT01196975|P3|Participant Flow|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198336|NCT01196975|P2|Participant Flow|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198337|NCT01196975|P1|Participant Flow|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198338|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198339|NCT01196975|O4|Outcome|Victoria Strain FluLaval|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198340|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198341|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198342|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198343|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198344|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198564|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198346|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198347|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198348|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198349|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198350|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198351|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198352|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198353|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198354|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198355|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198356|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198357|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198358|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198359|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198360|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198361|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198362|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198363|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198364|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198365|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198366|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198367|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198368|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198369|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198370|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198371|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198372|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198373|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
199134|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
198374|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198375|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198376|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198377|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198378|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198379|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198380|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198381|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198382|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198383|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198384|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198385|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198386|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198387|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198388|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198389|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198390|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198391|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198392|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198393|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198394|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198395|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198396|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198397|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
199135|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
198398|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198399|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198400|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198401|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198402|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198403|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198404|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198405|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198406|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198407|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198408|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198409|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198410|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198411|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198412|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198413|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198414|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198415|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198416|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198417|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198418|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198419|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198597|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198420|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198421|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198422|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198423|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198424|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198425|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198426|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198427|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198428|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198429|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198430|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198431|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198432|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198433|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198434|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198435|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198436|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198437|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198438|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
198439|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198440|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198441|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198442|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198443|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198444|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198445|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198446|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198447|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198448|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198449|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198450|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198451|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198452|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198453|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198454|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198455|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198456|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198457|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198458|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198459|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198460|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198461|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198462|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198463|NCT01196975|E5|Reported Event|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198464|NCT01196975|E4|Reported Event|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198465|NCT01196975|E3|Reported Event|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198466|NCT01196975|E2|Reported Event|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
198467|NCT01196975|E1|Reported Event|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm.
198468|NCT01196923|B1|Baseline|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
198469|NCT01196923|P1|Participant Flow|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
198470|NCT01196923|O1|Outcome|HeartLight Acutely Isolated Pulmonary Veins|
198471|NCT01196923|E1|Reported Event|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
198472|NCT01196741|B3|Baseline|Total|Total of all reporting groups
198501|NCT01196104|B1|Baseline|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198502|NCT01196104|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
199136|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
198473|NCT01196741|B2|Baseline|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198474|NCT01196741|B1|Baseline|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198475|NCT01196741|P2|Participant Flow|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198476|NCT01196741|P1|Participant Flow|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198477|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198478|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198479|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198480|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198481|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198482|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198483|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198503|NCT01196104|P1|Participant Flow|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198504|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
199126|NCT01195675|O3|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
198484|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198485|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198486|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198487|NCT01196741|E2|Reported Event|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198488|NCT01196741|E1|Reported Event|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
198489|NCT01196442|B1|Baseline|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198490|NCT01196442|P1|Participant Flow|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198491|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198492|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198493|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198494|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198495|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198496|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198497|NCT01196442|O1|Outcome|Arm I|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198498|NCT01196442|E1|Reported Event|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
198499|NCT01196104|B3|Baseline|Total|Total of all reporting groups
198500|NCT01196104|B2|Baseline|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198538|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198505|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198506|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198507|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198508|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198509|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198510|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198511|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198512|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198513|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198514|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198515|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198516|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198517|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198518|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198519|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198520|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198521|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198522|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198523|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198524|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198525|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198526|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198527|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198528|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198529|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198530|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198531|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198532|NCT01196104|O2|Outcome|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
198533|NCT01196104|O1|Outcome|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
198534|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198535|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198536|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
198537|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
199127|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
198539|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
198540|NCT01196104|E2|Reported Event|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
198541|NCT01196104|E1|Reported Event|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
198542|NCT01196078|B3|Baseline|Total|Total of all reporting groups
198543|NCT01196078|B2|Baseline|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198544|NCT01196078|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198545|NCT01196078|P2|Participant Flow|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198546|NCT01196078|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198547|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198548|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198549|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198550|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198551|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198552|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198553|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198554|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198555|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198556|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198557|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198558|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198559|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198560|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198561|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198562|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198563|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
199128|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
198565|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198566|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198567|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198568|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198569|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198570|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198571|NCT01196078|E2|Reported Event|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
198572|NCT01196078|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
198573|NCT01196052|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198574|NCT01196052|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198575|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198576|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198577|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198578|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198579|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198580|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198581|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198582|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198583|NCT01196052|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
198584|NCT01196026|B7|Baseline|Total|Total of all reporting groups
198585|NCT01196026|B6|Baseline|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198586|NCT01196026|B5|Baseline|Havrix Junior 12-35 Months Group|Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
198587|NCT01196026|B4|Baseline|Havrix Junior 6-11 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198588|NCT01196026|B3|Baseline|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198589|NCT01196026|B2|Baseline|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198590|NCT01196026|B1|Baseline|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198591|NCT01196026|P6|Participant Flow|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198592|NCT01196026|P5|Participant Flow|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198593|NCT01196026|P4|Participant Flow|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198594|NCT01196026|P3|Participant Flow|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198595|NCT01196026|P2|Participant Flow|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198596|NCT01196026|P1|Participant Flow|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198598|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198599|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198600|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198601|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198602|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198603|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198604|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198605|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198606|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198607|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198608|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198609|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198610|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198611|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198612|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198613|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198614|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198615|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198616|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198617|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198618|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198619|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198620|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198621|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198622|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198623|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198624|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198625|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198626|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198627|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198628|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198629|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198630|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
199129|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
198631|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198632|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198633|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198634|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198635|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198636|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198637|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198638|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198639|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198640|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198641|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198642|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198643|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198644|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198645|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198646|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198647|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198648|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198649|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198650|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198651|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198652|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198653|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198654|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198655|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198656|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198657|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198658|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198659|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198660|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198661|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198662|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198663|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
199130|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
198664|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198665|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198666|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198667|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198668|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198669|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198670|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198671|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198672|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198673|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198674|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198675|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198676|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198677|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198678|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198679|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198680|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198681|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198682|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198683|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198684|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198685|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198686|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198687|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198688|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198689|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198690|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198691|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198692|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198693|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198694|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198695|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198696|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198697|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198698|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198699|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198700|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198701|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198702|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198703|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198704|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198705|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198706|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198707|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198708|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198709|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198710|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198711|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198712|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198713|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198714|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198715|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198716|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198717|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198718|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198719|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198720|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198721|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198722|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198723|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198724|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198725|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198726|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198727|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198728|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198729|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198730|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198731|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198732|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198733|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198734|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198735|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198736|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198737|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198738|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198739|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198740|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198741|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198742|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198743|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198744|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198745|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198746|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198747|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198748|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198749|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198750|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198751|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198752|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198753|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198754|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198755|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198756|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198757|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198758|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198759|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198760|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198761|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198762|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198763|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198764|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198765|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198766|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198767|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198768|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198769|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198770|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198771|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198772|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198773|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198774|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198775|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198776|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198777|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
198778|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198779|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198780|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198781|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198782|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198783|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198784|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198785|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198786|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198787|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198788|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198789|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198790|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198791|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198792|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198793|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198794|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198795|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198796|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198797|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198798|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
199351|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
198799|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198800|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198801|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198802|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198803|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198804|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198805|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198806|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198807|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198808|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198809|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198810|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198811|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198812|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198813|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
198814|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198815|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198816|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198817|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198818|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198819|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198820|NCT01196026|E8|Reported Event|Havrix Junior Group|Subjects received 1 dose of Havrix Junior vacine. The second dose was administered outside the study setting.
198821|NCT01196026|E7|Reported Event|Fluarix Group|subjects received 1 or doses of Fluarix vaccine based on age and priming status
198822|NCT01196026|E6|Reported Event|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198823|NCT01196026|E5|Reported Event|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198824|NCT01196026|E4|Reported Event|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
198825|NCT01196026|E3|Reported Event|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198826|NCT01196026|E2|Reported Event|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198827|NCT01196026|E1|Reported Event|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
198828|NCT01195948|B4|Baseline|Total|Total of all reporting groups
198829|NCT01195948|B3|Baseline|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198830|NCT01195948|B2|Baseline|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198831|NCT01195948|B1|Baseline|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
225914|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
198832|NCT01195948|P3|Participant Flow|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198833|NCT01195948|P2|Participant Flow|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198834|NCT01195948|P1|Participant Flow|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198835|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198836|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198837|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198838|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198839|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198840|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198841|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198842|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198843|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198844|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198845|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198846|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
198847|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
198848|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198849|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198850|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
198851|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198852|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198853|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
198854|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
225915|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
198855|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198856|NCT01195948|E3|Reported Event|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
198857|NCT01195948|E2|Reported Event|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198858|NCT01195948|E1|Reported Event|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
198859|NCT01195922|B1|Baseline|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
198860|NCT01195922|P1|Participant Flow|Sirolimus|Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.
198861|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
198862|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
198863|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
198864|NCT01195922|E1|Reported Event|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
198865|NCT01195844|B1|Baseline|Children Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
198866|NCT01195844|P1|Participant Flow|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
198867|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
198868|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
198869|NCT01195844|O2|Outcome|Total Number Diagnosed With Rotavirus Diarrhea|Children up to 5 years of age diagnosed with rotavirus diarrhea in the 4 Brazilian hospital research centers
198870|NCT01195844|O1|Outcome|Total Number Hospitalized For Diarrhea of Any Cause|Total number of children up to 5 years of age hospitalized for diarrhea of any cause in the 4 Brazilian hospital research centers
198871|NCT01195844|O1|Outcome|Children Hospitalized For Rotavirus-Positive Diarrhea|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the 4 Brazilian hospital research centers
198872|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
198873|NCT01195844|O4|Outcome|São Paulo (Southeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
198874|NCT01195844|O3|Outcome|Porto Alegre (South)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
198875|NCT01195844|O2|Outcome|Goiânia (Center-West)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
198876|NCT01195844|O1|Outcome|Salvador (Northeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Salvador (Northeast Brazil) hospital research center
198877|NCT01195844|O1|Outcome|Children Hospitalized for Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
198878|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
198879|NCT01195844|E1|Reported Event|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
198880|NCT01195831|B3|Baseline|Total|Total of all reporting groups
198881|NCT01195831|B2|Baseline|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198882|NCT01195831|B1|Baseline|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198883|NCT01195831|P2|Participant Flow|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198884|NCT01195831|P1|Participant Flow|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198885|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198886|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198887|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198888|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198889|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198890|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198891|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198892|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198893|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198894|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198895|NCT01195831|E2|Reported Event|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
198896|NCT01195831|E1|Reported Event|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
198897|NCT01195779|B15|Baseline|Total|Total of all reporting groups
198898|NCT01195779|B14|Baseline|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198899|NCT01195779|B13|Baseline|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198900|NCT01195779|B12|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198901|NCT01195779|B11|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198902|NCT01195779|B10|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198903|NCT01195779|B9|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198904|NCT01195779|B8|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198905|NCT01195779|B7|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198906|NCT01195779|B6|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198907|NCT01195779|B5|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198908|NCT01195779|B4|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198909|NCT01195779|B3|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198910|NCT01195779|B2|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198911|NCT01195779|B1|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198912|NCT01195779|P14|Participant Flow|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198913|NCT01195779|P13|Participant Flow|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199352|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
198914|NCT01195779|P12|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198915|NCT01195779|P11|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198916|NCT01195779|P10|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198917|NCT01195779|P9|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198918|NCT01195779|P8|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198919|NCT01195779|P7|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198920|NCT01195779|P6|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198921|NCT01195779|P5|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198922|NCT01195779|P4|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198923|NCT01195779|P3|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198924|NCT01195779|P2|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198925|NCT01195779|P1|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198926|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198927|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198928|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198929|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198930|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198931|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198932|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198933|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198934|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198935|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198936|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198937|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198938|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198939|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198940|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198941|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198942|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198943|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198944|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198945|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198946|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198947|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198948|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198949|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198950|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198951|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198952|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198953|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198954|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198955|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198956|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198957|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198958|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198959|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198960|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198961|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198962|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198963|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198964|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198965|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198966|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198967|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198968|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198969|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198970|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198971|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198972|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198973|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198974|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198975|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198976|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198977|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198978|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198979|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198980|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198981|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198982|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198983|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198984|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198985|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198986|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198987|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
198988|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198989|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
198990|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198991|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
198992|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198993|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
198994|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198995|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
198996|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
198997|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
198998|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
198999|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199000|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199001|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199002|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199003|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199004|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199005|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199006|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199007|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199008|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199009|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199010|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199011|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199012|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199013|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199014|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199015|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199016|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199017|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199018|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199019|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199020|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199021|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199022|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199023|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199024|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199025|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199026|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199027|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199028|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199029|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199030|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199031|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199032|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199033|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199034|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199035|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199036|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199037|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199038|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199039|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199040|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199041|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199042|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199043|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199044|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199045|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199046|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199047|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199048|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199049|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199050|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199051|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199052|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199053|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199054|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199055|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199056|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199057|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199058|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199059|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199060|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199061|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199062|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199063|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199064|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199065|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199066|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199067|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199068|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199069|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199070|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199071|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199072|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199073|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199074|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199075|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199076|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199077|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199078|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199079|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199080|NCT01195779|E14|Reported Event|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
199081|NCT01195779|E13|Reported Event|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
199082|NCT01195779|E12|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199083|NCT01195779|E11|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
199084|NCT01195779|E10|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199085|NCT01195779|E9|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
199086|NCT01195779|E8|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199131|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
199087|NCT01195779|E7|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
199088|NCT01195779|E6|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199089|NCT01195779|E5|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
199090|NCT01195779|E4|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199091|NCT01195779|E3|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
199092|NCT01195779|E2|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199093|NCT01195779|E1|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
199094|NCT01195701|B3|Baseline|Total|Total of all reporting groups
199095|NCT01195701|B2|Baseline|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199096|NCT01195701|B1|Baseline|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199097|NCT01195701|P2|Participant Flow|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199098|NCT01195701|P1|Participant Flow|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199099|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199100|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199101|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199102|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199103|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199104|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199105|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199106|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199107|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199108|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199109|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199110|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199111|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199112|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199113|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199114|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199115|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199116|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199117|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199118|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199119|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199120|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199121|NCT01195701|E2|Reported Event|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
199122|NCT01195701|E1|Reported Event|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
199123|NCT01195675|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
199124|NCT01195675|P1|Participant Flow|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were~25mg empa administered orally on day 1 of the treatment period~200mg empa administered orally on day 1 of the treatment period~400mg moxifloxacin administered orally on day 1 of the treatment period~Placebo 1 administered orally on day 1 of the treatment period~Placebo 2 administered orally on day 1 of the treatment period~The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations."
199125|NCT01195675|O4|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
199132|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
199137|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
199138|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199139|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
199140|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199141|NCT01195675|O2|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
199142|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199143|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
199144|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199145|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
199146|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199147|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
199148|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
199149|NCT01195675|E4|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
199150|NCT01195675|E3|Reported Event|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
199151|NCT01195675|E2|Reported Event|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
199152|NCT01195675|E1|Reported Event|Placebo|Single oral dose of placebo (8 tablets).
199153|NCT01195662|B4|Baseline|Total|Total of all reporting groups
199154|NCT01195662|B3|Baseline|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|Dapagliflozin: Tablets, Oral, 5 mg, once daily, Up to 12 weeks. This arm discontinued with implementation of Amendment 8 to the protocol (1 November 2011). Study continued to enroll participants in other 2 arms post Amendment 8. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199155|NCT01195662|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199156|NCT01195662|B1|Baseline|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199157|NCT01195662|P3|Participant Flow|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
199158|NCT01195662|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199159|NCT01195662|P1|Participant Flow|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199160|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199161|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199162|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199163|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199206|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199207|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199164|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199165|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199166|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199167|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199168|NCT01195662|O3|Outcome|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
199169|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199170|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199171|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199172|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199173|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199174|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199175|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199176|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks.Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199177|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199178|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199208|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199353|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199179|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199180|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199181|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199182|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199183|NCT01195662|E3|Reported Event|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
199184|NCT01195662|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199185|NCT01195662|E1|Reported Event|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
199186|NCT01195636|B3|Baseline|Total|Total of all reporting groups
199187|NCT01195636|B2|Baseline|Placebo First, Then XPF-002|Placebo ointment applied twice daily for 3 weeks followed by XPF-002 ointment applied twice daily for 3 weeks (after a washout period)
199188|NCT01195636|B1|Baseline|XPF-002 First, Then Placebo|XPF-002 ointment applied twice daily for 3 weeks followed by Placebo ointment applied twice daily for 3 weeks (after a washout period)
199189|NCT01195636|P2|Participant Flow|Placebo First, Then XPF-002|In the first intervention period Placebo ointment was applied twice daily for 3 weeks. After a washout period, XPF-002 ointment (8% strength) was applied twice daily for 3 weeks in the second intervention period.
199190|NCT01195636|P1|Participant Flow|XPF-002 First, Then Placebo|In the first intervention period XPF-002 ointment (8% strength) was applied twice daily for 3 weeks. After a washout period, Placebo ointment was applied twice daily for 3 weeks in the second intervention period.
199191|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199192|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199193|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199194|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199195|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199196|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199197|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199198|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199199|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199200|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199201|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199202|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199203|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199204|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199205|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199286|NCT01195116|O2|Outcome|Normal Saline|Normal Saline: 1mcg/kg/hr
199209|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199210|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199211|NCT01195636|E2|Reported Event|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
199212|NCT01195636|E1|Reported Event|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
199213|NCT01195623|B3|Baseline|Total|Total of all reporting groups
199214|NCT01195623|B2|Baseline|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
199215|NCT01195623|B1|Baseline|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
199216|NCT01195623|P2|Participant Flow|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
199217|NCT01195623|P1|Participant Flow|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
199218|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
199219|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
199220|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
199221|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
199222|NCT01195623|E2|Reported Event|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
199223|NCT01195623|E1|Reported Event|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
199224|NCT01195597|B1|Baseline|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
199225|NCT01195597|P1|Participant Flow|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
199226|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
199227|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
199228|NCT01195597|E1|Reported Event|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
199229|NCT01195584|B4|Baseline|Total|Total of all reporting groups
199230|NCT01195584|B3|Baseline|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
199231|NCT01195584|B2|Baseline|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
199232|NCT01195584|B1|Baseline|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
199233|NCT01195584|P3|Participant Flow|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
199234|NCT01195584|P2|Participant Flow|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
199235|NCT01195584|P1|Participant Flow|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
199236|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
199237|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
199238|NCT01195584|O1|Outcome|Number of Segments|Number of affected spine segments
199239|NCT01195584|O1|Outcome|Blood Loss|
199240|NCT01195584|O1|Outcome|Duration|Duration of surgery
199241|NCT01195584|O1|Outcome|Complications|Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
199242|NCT01195584|E3|Reported Event|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
199243|NCT01195584|E2|Reported Event|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
199244|NCT01195584|E1|Reported Event|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
199245|NCT01195467|B1|Baseline|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
199246|NCT01195467|P1|Participant Flow|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
199247|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
199248|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
199249|NCT01195467|E1|Reported Event|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
199349|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199350|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199250|NCT01195415|B1|Baseline|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
199251|NCT01195415|P1|Participant Flow|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
199252|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
199253|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
199254|NCT01195415|E1|Reported Event|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
199255|NCT01195363|B3|Baseline|Total|Total of all reporting groups
199256|NCT01195363|B2|Baseline|Quetiapine SR Placebo|mood stabilizer plus quetiapine SR placebo
199257|NCT01195363|B1|Baseline|Active Quetiapine SR|mood stabilizer plus active quetiapine sr
199258|NCT01195363|P2|Participant Flow|Quetiapine sr Placebo 200-600mg, po, qd|mood stabilizer plus quetiapine SR placebo
199259|NCT01195363|P1|Participant Flow|Quetiapine SR, 200-600mg , po, QD|mood stabilizer plus active quetiapine SR
199260|NCT01195363|O2|Outcome|Placebo Quetiapine S.R. 200-600mg, po, qd|mood stabilizer plus quetiapine S.R. placebo
199261|NCT01195363|O1|Outcome|Active Quetiapine S.R., 200-600mg, po, qd|Atypical antipsychotic quetiapine S.R. plus mood stabilizer
199262|NCT01195363|E2|Reported Event|Mood Stabilizer Plus Quetiapine sr Placebo|mood stabilizer plus quetiapine SR placebo
199263|NCT01195363|E1|Reported Event|Mood Stabilizer Plus Quetiapine SR|mood stabilizer plus active quetiapine SR
199264|NCT01195272|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199265|NCT01195272|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).
199266|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199267|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199268|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199269|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199270|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199271|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199272|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199273|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199274|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199275|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199276|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199277|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199278|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199279|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199280|NCT01195272|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
199281|NCT01195116|B3|Baseline|Total|Total of all reporting groups
199282|NCT01195116|B2|Baseline|Normal Saline|Normal Saline: 1mcg/kg/hr
199283|NCT01195116|B1|Baseline|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
199284|NCT01195116|P2|Participant Flow|Normal Saline|Normal Saline: 1mcg/kg/hr
199285|NCT01195116|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
199287|NCT01195116|O1|Outcome|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
199288|NCT01195116|E2|Reported Event|Normal Saline|Normal Saline: 1mcg/kg/hr
199289|NCT01195116|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
199290|NCT01195103|B4|Baseline|Total|Total of all reporting groups
199291|NCT01195103|B3|Baseline|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
199292|NCT01195103|B2|Baseline|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
199293|NCT01195103|B1|Baseline|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
199294|NCT01195103|P3|Participant Flow|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
199295|NCT01195103|P2|Participant Flow|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
199296|NCT01195103|P1|Participant Flow|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
199297|NCT01195103|O3|Outcome|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
199298|NCT01195103|O2|Outcome|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
199299|NCT01195103|O1|Outcome|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
199300|NCT01195103|E3|Reported Event|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
199301|NCT01195103|E2|Reported Event|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
199302|NCT01195103|E1|Reported Event|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
199303|NCT01195090|B3|Baseline|Total|Total of all reporting groups
199304|NCT01195090|B2|Baseline|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199305|NCT01195090|B1|Baseline|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199306|NCT01195090|P2|Participant Flow|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199307|NCT01195090|P1|Participant Flow|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199308|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199309|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199310|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199311|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199312|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199313|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199314|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199315|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199316|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199317|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199318|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199319|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199320|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199321|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199322|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199323|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199324|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199325|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199326|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199327|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199328|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199329|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199330|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199331|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199332|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199333|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199334|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199335|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199336|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199337|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199338|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199339|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199340|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199341|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199342|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199343|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199344|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199345|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199346|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199347|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199348|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199354|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199355|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199356|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199357|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199358|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199359|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199360|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199361|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199362|NCT01195090|E2|Reported Event|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
199363|NCT01195090|E1|Reported Event|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
199364|NCT01195025|B1|Baseline|Dilution Effects of iv Fluids|"Three experiments:~A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes."
199365|NCT01195025|P5|Participant Flow|A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected."
199366|NCT01195025|P4|Participant Flow|A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
199367|NCT01195025|P3|Participant Flow|A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples."
199368|NCT01195025|P2|Participant Flow|A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected"
199369|NCT01195025|P1|Participant Flow|A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
199370|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
199371|NCT01195025|O1|Outcome|Colloid (Voluven), Acetated Ringers and a Combination of Both.|"A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes~The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant."
199372|NCT01195025|O1|Outcome|Venous Hemoglobin and Non-invasive Hemoglobin (SpHb)|"A comparison of all paired hemoglobin measurements (B-Hb and SpHb) during the experiments for all the 10 volunteers.~Relative difference(%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"
199373|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
199374|NCT01195025|E1|Reported Event|Colloid-, Acetated Ringers and Combined|"Voluven, acetated Ringers: Infusions at three different occasions separated by at least one week.~A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes."
199375|NCT01194999|B1|Baseline|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
199376|NCT01194999|P1|Participant Flow|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
199377|NCT01194999|O1|Outcome|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
199378|NCT01194999|E1|Reported Event|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
199428|NCT01194830|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199429|NCT01194830|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199379|NCT01194973|B1|Baseline|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199380|NCT01194973|P1|Participant Flow|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199381|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199382|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199383|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199384|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199385|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199386|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199387|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199388|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199389|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199390|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199391|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199392|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199430|NCT01194154|B3|Baseline|Total|Total of all reporting groups
199431|NCT01194154|B2|Baseline|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199473|NCT01194531|B1|Baseline|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
199393|NCT01194973|E1|Reported Event|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
199394|NCT01194908|B1|Baseline|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
199395|NCT01194908|P1|Participant Flow|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
199396|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
199397|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
199398|NCT01194908|E1|Reported Event|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
199399|NCT01194869|B1|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199400|NCT01194869|P1|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199401|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199402|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199403|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199404|NCT01194869|E1|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
199405|NCT01194830|B3|Baseline|Total|Total of all reporting groups
199406|NCT01194830|B2|Baseline|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199407|NCT01194830|B1|Baseline|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199408|NCT01194830|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199409|NCT01194830|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199410|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199411|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199412|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199413|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199414|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199415|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199416|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199417|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199418|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199419|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199420|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199421|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199422|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199423|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199424|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199425|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199426|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
199427|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
199432|NCT01194154|B1|Baseline|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199433|NCT01194154|P2|Participant Flow|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199434|NCT01194154|P1|Participant Flow|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
199435|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199436|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
199437|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199438|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/ dL.
199439|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199440|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
199441|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199442|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199443|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199444|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199445|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199446|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199447|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199448|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199449|NCT01194154|E2|Reported Event|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
199450|NCT01194154|E1|Reported Event|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
199451|NCT01194089|B3|Baseline|Total|Total of all reporting groups
199452|NCT01194089|B2|Baseline|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199453|NCT01194089|B1|Baseline|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199454|NCT01194089|P2|Participant Flow|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199455|NCT01194089|P1|Participant Flow|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199456|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199457|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199458|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199459|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199460|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199461|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199462|NCT01194089|E2|Reported Event|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
199463|NCT01194089|E1|Reported Event|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
199464|NCT01194674|B1|Baseline|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199465|NCT01194674|P1|Participant Flow|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199466|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199467|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199468|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199469|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199470|NCT01194674|E1|Reported Event|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
199471|NCT01194531|B3|Baseline|Total|Total of all reporting groups
199472|NCT01194531|B2|Baseline|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
225916|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
199474|NCT01194531|P2|Participant Flow|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
199475|NCT01194531|P1|Participant Flow|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
199476|NCT01194531|O2|Outcome|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
199477|NCT01194531|O1|Outcome|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
199478|NCT01194531|E2|Reported Event|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
199479|NCT01194531|E1|Reported Event|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
199480|NCT01194479|B3|Baseline|Total|Total of all reporting groups
199481|NCT01194479|B2|Baseline|Type 1 Diabetics|"The active group were participants with type 1 diabetes.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
199482|NCT01194479|B1|Baseline|Healthy Volunteers|"The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
199483|NCT01194479|P4|Participant Flow|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol first, then Placebo.
199484|NCT01194479|P3|Participant Flow|Type 1 Diabetics: Placebo|Type 1 Diabetics that received Placebo first, then Formoterol.
199485|NCT01194479|P2|Participant Flow|Control: Formoterol|Healthy volunteers that received Formoterol first, then Placebo.
199486|NCT01194479|P1|Participant Flow|Control: Placebo|Healthy volunteers that received Placebo first, the Formoterol.
199487|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
199488|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
199489|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
199490|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
199491|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
199492|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
199493|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
199494|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
199495|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
199496|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
199497|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
199498|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
199499|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
199500|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
199501|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
199502|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
199503|NCT01194479|E4|Reported Event|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first visit.
199504|NCT01194479|E3|Reported Event|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first visit.
199505|NCT01194479|E2|Reported Event|Control: Formoterol|Healthy volunteers that received Formoterol on the first visit.
199506|NCT01194479|E1|Reported Event|Control: Placebo|Healthy volunteers that received Placebo on the first visit.
199507|NCT01194453|B3|Baseline|Total|Total of all reporting groups
199508|NCT01194453|B2|Baseline|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
199509|NCT01194453|B1|Baseline|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
199510|NCT01194453|P2|Participant Flow|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
199511|NCT01194453|P1|Participant Flow|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
199512|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
199513|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
225917|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
199514|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
199515|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
199516|NCT01194453|E2|Reported Event|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
199517|NCT01194453|E1|Reported Event|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
199518|NCT01194440|B1|Baseline|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
199519|NCT01194440|P1|Participant Flow|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
199520|NCT01194440|O1|Outcome|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
199521|NCT01194440|E1|Reported Event|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
199522|NCT01194427|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
199523|NCT01194427|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
199524|NCT01194427|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
199525|NCT01194427|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
199526|NCT01194414|B3|Baseline|Total|Total of all reporting groups
199527|NCT01194414|B2|Baseline|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199528|NCT01194414|B1|Baseline|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199529|NCT01194414|P4|Participant Flow|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199530|NCT01194414|P3|Participant Flow|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199531|NCT01194414|P2|Participant Flow|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199532|NCT01194414|P1|Participant Flow|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199533|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199534|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199535|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199536|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199537|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199538|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199539|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199540|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199541|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199542|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199543|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199544|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199545|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199546|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199547|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199548|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199549|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
225918|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
199550|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199551|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199552|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199553|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199554|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199555|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199556|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199557|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199558|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199559|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199560|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199561|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199562|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199563|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199564|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199565|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199566|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
225919|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
199567|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199568|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199569|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199570|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199571|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199572|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199573|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199574|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199575|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199576|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199577|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199578|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199579|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199580|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199581|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199582|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199583|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199584|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199585|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199586|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
199587|NCT01194414|E4|Reported Event|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
199588|NCT01194414|E3|Reported Event|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199589|NCT01194414|E2|Reported Event|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199590|NCT01194414|E1|Reported Event|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
199591|NCT01194297|B3|Baseline|Total|Total of all reporting groups
199592|NCT01194297|B2|Baseline|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
199593|NCT01194297|B1|Baseline|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
199594|NCT01194297|P2|Participant Flow|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
199595|NCT01194297|P1|Participant Flow|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
199596|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
199597|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
199598|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
199599|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
199600|NCT01194297|E2|Reported Event|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
199601|NCT01194297|E1|Reported Event|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
199602|NCT01194258|B1|Baseline|All Study Participants|All participants in the study, including those who were enrolled but were not randomized.
199603|NCT01194258|P5|Participant Flow|Aspart-PH20, Then Insulin Lispro|"Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
199604|NCT01194258|P4|Participant Flow|Insulin Lispro, Then Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
199605|NCT01194258|P3|Participant Flow|Lispro-PH20, Then Insulin Lispro|"Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
199606|NCT01194258|P2|Participant Flow|Insulin Lispro, Then Lispro-PH20|"Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
199607|NCT01194258|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199608|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199609|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199610|NCT01194258|O2|Outcome|Insulin-lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199611|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (Insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199612|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199613|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199614|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199615|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199616|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199617|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199618|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199619|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
199620|NCT01194258|E5|Reported Event|Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199621|NCT01194258|E4|Reported Event|Insulin Lispro (Aspart-PH20 Cohort)|"Participants randomized to the Aspart-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199622|NCT01194258|E3|Reported Event|Lispro-PH20|"Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199623|NCT01194258|E2|Reported Event|Insulin Lispro (Lispro-PH20 Cohort)|"Participants randomized to the Lispro-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199624|NCT01194258|E1|Reported Event|Titration Period|Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
199625|NCT01194245|B6|Baseline|Total|Total of all reporting groups
199626|NCT01194245|B5|Baseline|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199627|NCT01194245|B4|Baseline|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199628|NCT01194245|B3|Baseline|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199647|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199705|NCT01193920|P8|Participant Flow|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
200057|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
199629|NCT01194245|B2|Baseline|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199630|NCT01194245|B1|Baseline|Non-randomized Participants|"Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.~Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized."
199631|NCT01194245|P5|Participant Flow|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199632|NCT01194245|P4|Participant Flow|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199633|NCT01194245|P3|Participant Flow|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199634|NCT01194245|P2|Participant Flow|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199635|NCT01194245|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199636|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199637|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199638|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199639|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199640|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199641|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199642|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199643|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199644|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199645|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199646|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
199648|NCT01194245|E5|Reported Event|Insulin Lispro (Aspart-PH20 Cohort) Treatment Period|"Participants were randomized to the Aspart-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199649|NCT01194245|E4|Reported Event|Aspart-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199650|NCT01194245|E3|Reported Event|Insulin Lispro (Lispro-PH20 Cohort) Treatment Period|"Participants were randomized to the Lispro-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199651|NCT01194245|E2|Reported Event|Lispro-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199652|NCT01194245|E1|Reported Event|Titration Period (All Enrolled Participants)|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
199653|NCT01194219|B3|Baseline|Total|Total of all reporting groups
199654|NCT01194219|B2|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
199655|NCT01194219|B1|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
199656|NCT01194219|P8|Participant Flow|PBO-APR-APR + Optional Topicals/ UVB|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of < PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 ans remained on APR 30 mg BID for the remainder of their participation.
199657|NCT01194219|P7|Participant Flow|APR-APR-APR + Optional Topicals/UVB|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
199658|NCT01194219|P6|Participant Flow|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
199659|NCT01194219|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered responders [ie, having a ≥ Psoriasis Area and Severity Index score of 75 (PASI-75) response] were re-randomized to PBO during the Randomized Withdrawal Phase (weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260, and received APR 30 mg BID for the remainder of their participation.
199660|NCT01194219|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to identically matching PBO BID during the Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32)
199661|NCT01194219|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
199662|NCT01194219|P2|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
199663|NCT01194219|P1|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
199664|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
199665|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
199666|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
199667|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199668|NCT01194219|O2|Outcome|APR-APR -Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until Week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed.
199669|NCT01194219|O1|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52).
199670|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
199671|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199672|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16).
199673|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199674|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
199675|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199676|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
199677|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199678|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
199679|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
199680|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
199681|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
199682|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
199683|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199684|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
199685|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
199686|NCT01194219|O2|Outcome|Placebo (PBO)|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
199687|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
199688|NCT01194219|E4|Reported Event|Weeks 0-52: APR-Exposure Period|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
199689|NCT01194219|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
199690|NCT01194219|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
199691|NCT01194219|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
199692|NCT01193920|B11|Baseline|Total|Total of all reporting groups
199693|NCT01193920|B10|Baseline|Infants / Placebo|Infants born from women who received one injection of saline solution
199694|NCT01193920|B9|Baseline|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199695|NCT01193920|B8|Baseline|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199696|NCT01193920|B7|Baseline|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199697|NCT01193920|B6|Baseline|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199698|NCT01193920|B5|Baseline|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199699|NCT01193920|B4|Baseline|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199700|NCT01193920|B3|Baseline|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199701|NCT01193920|B2|Baseline|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199702|NCT01193920|B1|Baseline|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199703|NCT01193920|P10|Participant Flow|Infants / Placebo|Infants born from women who received saline solution
199704|NCT01193920|P9|Participant Flow|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
200518|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
199706|NCT01193920|P7|Participant Flow|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199707|NCT01193920|P6|Participant Flow|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199708|NCT01193920|P5|Participant Flow|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199709|NCT01193920|P4|Participant Flow|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199710|NCT01193920|P3|Participant Flow|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199711|NCT01193920|P2|Participant Flow|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199712|NCT01193920|P1|Participant Flow|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199713|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
199714|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199715|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199716|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199717|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
199718|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199719|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199720|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199721|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199722|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199723|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199724|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199725|NCT01193920|O2|Outcome|Non Pregnant/Placebo|Non pregnant women received two injections of saline solution
199726|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199727|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199728|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199729|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199730|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199731|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199732|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199733|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199734|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199735|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199736|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199737|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199738|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199739|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199740|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199741|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199742|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199743|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199744|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199745|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199746|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199747|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199748|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199749|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199750|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199751|NCT01193920|E10|Reported Event|Infants / Placebo|Infants born from women who received one injection of saline solution
199752|NCT01193920|E9|Reported Event|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199753|NCT01193920|E8|Reported Event|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199754|NCT01193920|E7|Reported Event|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199755|NCT01193920|E6|Reported Event|Pregnant/Placebo|Pregnant women who received one injection of saline solution
199756|NCT01193920|E5|Reported Event|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
199757|NCT01193920|E4|Reported Event|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
199758|NCT01193920|E3|Reported Event|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
199759|NCT01193920|E2|Reported Event|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
199760|NCT01193920|E1|Reported Event|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
199761|NCT01193907|B5|Baseline|Total|Total of all reporting groups
199762|NCT01193907|B4|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199763|NCT01193907|B3|Baseline|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199764|NCT01193907|B2|Baseline|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199765|NCT01193907|B1|Baseline|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199766|NCT01193907|P4|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199767|NCT01193907|P3|Participant Flow|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199768|NCT01193907|P2|Participant Flow|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199769|NCT01193907|P1|Participant Flow|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199770|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199771|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199772|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199773|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199774|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199775|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199776|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199777|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199778|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199779|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199780|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199781|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199782|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199783|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199784|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199785|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199786|NCT01193907|E4|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
199787|NCT01193907|E3|Reported Event|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
199788|NCT01193907|E2|Reported Event|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
199789|NCT01193907|E1|Reported Event|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
199790|NCT01193868|B1|Baseline|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199791|NCT01193868|P1|Participant Flow|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199792|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199793|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199794|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199795|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199796|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199797|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199798|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199799|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199800|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199801|NCT01193868|E1|Reported Event|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
199802|NCT01193686|B3|Baseline|Total|Total of all reporting groups
199803|NCT01193686|B2|Baseline|Recipients of Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.
199804|NCT01193686|B1|Baseline|Veteran Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.
199805|NCT01193686|P2|Participant Flow|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
199806|NCT01193686|P1|Participant Flow|Veteran Peer Visitors|Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.
199807|NCT01193686|O2|Outcome|Recipients of PV|
199808|NCT01193686|O1|Outcome|Veteran Peer Visitors|
199809|NCT01193686|O2|Outcome|Recipients of PV|
199810|NCT01193686|O1|Outcome|Veteran Peer Visitors|
199811|NCT01193686|O2|Outcome|Recipients of PV|
199812|NCT01193686|O1|Outcome|Veteran Peer Visitors|
199813|NCT01193686|O2|Outcome|Recipients of PV|
199814|NCT01193686|O1|Outcome|Veteran Peer Visitors|
199815|NCT01193686|O2|Outcome|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
199816|NCT01193686|O1|Outcome|Veteran Peer Visitors|
199817|NCT01193686|E2|Reported Event|Recipients of Veteran Peer Visitation|Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
199818|NCT01193686|E1|Reported Event|Veteran Peer Visitors|Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.
199819|NCT01193660|B4|Baseline|Total|Total of all reporting groups
199820|NCT01193660|B3|Baseline|Only Rehabilitation|Active rehabilitation
199821|NCT01193660|B2|Baseline|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199822|NCT01193660|B1|Baseline|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199823|NCT01193660|P3|Participant Flow|Only Rehabilitation|Active rehabilitation
199824|NCT01193660|P2|Participant Flow|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199825|NCT01193660|P1|Participant Flow|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199826|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199827|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199828|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199829|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199830|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199831|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199832|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199833|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199834|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199835|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199836|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199837|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199838|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199839|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199840|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199841|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199842|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199843|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199844|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199845|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199846|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199847|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199848|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199849|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199850|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199851|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199852|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199853|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199854|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199855|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199856|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
199857|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199858|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199859|NCT01193660|E3|Reported Event|Only Rehabilitation|Active rehabilitation
199860|NCT01193660|E2|Reported Event|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
199861|NCT01193660|E1|Reported Event|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
199862|NCT01193582|B5|Baseline|Total|Total of all reporting groups
199863|NCT01193582|B4|Baseline|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
199864|NCT01193582|B3|Baseline|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199865|NCT01193582|B2|Baseline|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199866|NCT01193582|B1|Baseline|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199867|NCT01193582|P4|Participant Flow|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
199868|NCT01193582|P3|Participant Flow|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199869|NCT01193582|P2|Participant Flow|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199870|NCT01193582|P1|Participant Flow|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199871|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
199872|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199873|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199874|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199875|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
199876|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199877|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199878|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199879|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199880|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199881|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199882|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199883|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199884|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199885|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
199886|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199887|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199888|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199889|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
199890|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199891|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199892|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199893|NCT01193582|E4|Reported Event|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
199894|NCT01193582|E3|Reported Event|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
199895|NCT01193582|E2|Reported Event|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
199896|NCT01193582|E1|Reported Event|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
199897|NCT01193556|B3|Baseline|Total|Total of all reporting groups
199898|NCT01193556|B2|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
199899|NCT01193556|B1|Baseline|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
199900|NCT01193556|P2|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
199901|NCT01193556|P1|Participant Flow|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
199902|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
199903|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
199904|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
199905|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
199906|NCT01193556|E2|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
199907|NCT01193556|E1|Reported Event|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
199908|NCT01193348|B1|Baseline|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199909|NCT01193348|P1|Participant Flow|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199910|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|≥40kg weight cohort
199911|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|30 – <40kg weight cohort
199912|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|20 – <30kg weight cohort
199913|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|10 – <20kg weight cohort
199914|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|5 – <10kg weight cohort
199915|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199916|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199917|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199918|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199919|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199920|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199921|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199922|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199923|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199924|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199925|NCT01193348|E1|Reported Event|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
199926|NCT01193335|B3|Baseline|Total|Total of all reporting groups
199927|NCT01193335|B2|Baseline|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199928|NCT01193335|B1|Baseline|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199979|NCT01193335|O3|Outcome|13vPnC Group 1C|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199929|NCT01193335|P2|Participant Flow|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199930|NCT01193335|P1|Participant Flow|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199931|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199932|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199933|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199934|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199935|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199936|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199937|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199938|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199939|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199940|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199941|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199942|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199943|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199944|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199945|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199946|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199947|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199948|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199949|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199950|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199951|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200055|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
199952|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199953|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199954|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199955|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199956|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199957|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199958|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199959|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199960|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199961|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199962|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199963|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199964|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199965|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199966|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199967|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199968|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199969|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199970|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199971|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199972|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199973|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199974|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm infant participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199975|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199976|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199977|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199978|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
225920|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
199980|NCT01193335|O2|Outcome|13vPnC Group 1B|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199981|NCT01193335|O1|Outcome|13vPnC Group 1A|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199982|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199983|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199984|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199985|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199986|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199987|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199988|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199989|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199990|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199991|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199992|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199993|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199994|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199995|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199996|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199997|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
199998|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
199999|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200000|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200056|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200001|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200002|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200003|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200004|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200005|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200006|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200007|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200008|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200009|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200010|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200011|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200012|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
200013|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
200014|NCT01193335|E10|Reported Event|13vPnC Group 2 (Term Infant) - 2 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
200015|NCT01193335|E9|Reported Event|13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
200016|NCT01193335|E8|Reported Event|13vPnC Group 2 (Term Infant) - 1 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
200017|NCT01193335|E7|Reported Event|13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
200018|NCT01193335|E6|Reported Event|13vPnC Group 2 (Term Infant) - Toddler Dose|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
200019|NCT01193335|E5|Reported Event|13vPnC Group 1 (Preterm Infant) - Toddler Dose|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
200020|NCT01193335|E4|Reported Event|13vPnC Group 2 (Term Infant) - After Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
200519|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200021|NCT01193335|E3|Reported Event|13vPnC Group 1 (Preterm Infant) - After Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
200022|NCT01193335|E2|Reported Event|13vPnC Group 2 (Term Infant) - Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
200023|NCT01193335|E1|Reported Event|13vPnC Group 1 (Preterm Infant) - Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
200024|NCT01193283|B1|Baseline|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
200025|NCT01193283|P1|Participant Flow|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
200026|NCT01193283|O1|Outcome|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
200027|NCT01193283|E1|Reported Event|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
200028|NCT01193218|B6|Baseline|Total|Total of all reporting groups
200029|NCT01193218|B5|Baseline|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
200030|NCT01193218|B4|Baseline|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200031|NCT01193218|B3|Baseline|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200032|NCT01193218|B2|Baseline|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
200033|NCT01193218|B1|Baseline|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200034|NCT01193218|P8|Participant Flow|Empa 50 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
200035|NCT01193218|P7|Participant Flow|Empa 50mg\10mg|It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
200036|NCT01193218|P6|Participant Flow|Empa 25mg|Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
200037|NCT01193218|P5|Participant Flow|Empa 10mg|Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
200038|NCT01193218|P4|Participant Flow|Empa 5 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
200039|NCT01193218|P3|Participant Flow|Empa 5mg/10mg|It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
200040|NCT01193218|P2|Participant Flow|Placebo/Empa 25 mg|It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
200041|NCT01193218|P1|Participant Flow|Placebo/Empa 10mg|It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
200042|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
200043|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200044|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200045|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
200046|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200047|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
200048|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200049|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200050|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
200051|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200052|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
200053|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200054|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200058|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200059|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200060|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
200061|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200062|NCT01193218|E9|Reported Event|Empa 25mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 25 mg once daily for 52−week treatment
200063|NCT01193218|E8|Reported Event|Empa 10mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 10 mg once daily for 52−week treatment
200064|NCT01193218|E7|Reported Event|Empa 25mg (Randomized, 52 Week)|Patients randomized to empagliflozin 25 mg once daily for 52 weeks
200065|NCT01193218|E6|Reported Event|Empa 10mg (Randomized, 52 Week)|Patients randomized to empagliflozin 10mg once daily for 52 weeks
200066|NCT01193218|E5|Reported Event|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
200067|NCT01193218|E4|Reported Event|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
200068|NCT01193218|E3|Reported Event|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
200069|NCT01193218|E2|Reported Event|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
200070|NCT01193218|E1|Reported Event|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
200071|NCT01193153|B1|Baseline|Entire Study Population|Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
200072|NCT01193153|P2|Participant Flow|Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
200073|NCT01193153|P1|Participant Flow|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200074|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200075|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200076|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
200077|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200078|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200079|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200080|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
200081|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200082|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200083|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200084|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
225921|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
200085|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200086|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200087|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200088|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
200089|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200090|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200091|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200092|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200093|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200094|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
200095|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200096|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200097|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200098|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
200099|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200100|NCT01193153|E3|Reported Event|Double Blind - Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
200101|NCT01193153|E2|Reported Event|Double Blind - Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
200154|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200155|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200156|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200157|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200158|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
225922|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
200102|NCT01193153|E1|Reported Event|Open Label - Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period.
200103|NCT01193127|B5|Baseline|Total|Total of all reporting groups
200104|NCT01193127|B4|Baseline|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200105|NCT01193127|B3|Baseline|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200106|NCT01193127|B2|Baseline|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200107|NCT01193127|B1|Baseline|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200108|NCT01193127|P4|Participant Flow|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200109|NCT01193127|P3|Participant Flow|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200110|NCT01193127|P2|Participant Flow|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200111|NCT01193127|P1|Participant Flow|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200112|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200113|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200114|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200115|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200116|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200117|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200118|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200119|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200120|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200121|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200122|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200123|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200124|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200125|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200126|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200127|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200128|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200129|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200130|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200131|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200132|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200133|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200134|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200135|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200136|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200137|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200138|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200139|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200140|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200141|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200142|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200143|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200144|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200145|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200146|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200147|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200148|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200149|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200150|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200151|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200152|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200153|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200159|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200160|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200161|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200162|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200163|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200164|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200165|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200166|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200167|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200168|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200169|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200170|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200171|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200172|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200173|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200174|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200175|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200176|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200177|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200178|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200179|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200180|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200181|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200182|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200183|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200184|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200185|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200186|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200187|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200188|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200189|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200190|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200191|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200192|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200193|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200194|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200195|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200196|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200197|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200198|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200199|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200200|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200201|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200202|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200203|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200204|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200205|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200206|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200207|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200208|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200209|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200210|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200211|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200212|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200213|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200214|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200215|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200216|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200217|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200218|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200219|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200220|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200221|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200222|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200223|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200224|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200225|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200226|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200227|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200228|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200229|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200230|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200231|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200232|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200233|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200234|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200235|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200236|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200237|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200238|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200239|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200240|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200241|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200242|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200243|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200244|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200245|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200246|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200247|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200248|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200249|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200250|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200251|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200252|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200253|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200254|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200255|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200256|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200257|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200258|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200259|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200260|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200261|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200262|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200263|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200264|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200265|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200266|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200267|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200268|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200269|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200270|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200271|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200272|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200273|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200274|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200275|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200276|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200277|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200278|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200279|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
200280|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200281|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200282|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200283|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
200284|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200285|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200286|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200287|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200288|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200289|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200290|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200291|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200292|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200293|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200294|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200295|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200296|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200297|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200298|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200299|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200300|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200301|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200302|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200303|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200304|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200305|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200306|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200307|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200308|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200309|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200310|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200311|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200312|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200313|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200314|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200315|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200316|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200317|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200318|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200319|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200320|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200321|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200322|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200323|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200324|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200325|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200326|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200327|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200328|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200329|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200330|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200331|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200332|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200333|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200334|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200335|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200336|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200337|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200338|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200339|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200340|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200341|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200342|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200343|NCT01193127|O1|Outcome|Solution|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200344|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200345|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200346|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200347|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200348|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200349|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200350|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200351|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200352|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200353|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200354|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200355|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200356|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200357|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200358|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200359|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200360|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200361|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200362|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200363|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200364|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200365|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200366|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200367|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200368|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200369|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200370|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200371|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200372|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200373|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200374|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200375|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200376|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200377|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200378|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200379|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200380|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200381|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200382|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200383|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200384|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200385|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200386|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200387|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200388|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200389|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200390|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200391|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200392|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200393|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200394|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200395|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200396|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200397|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200398|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200399|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200400|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200401|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200402|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200403|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200404|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200405|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200406|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200407|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200408|NCT01193127|E4|Reported Event|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
200409|NCT01193127|E3|Reported Event|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
200410|NCT01193127|E2|Reported Event|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
200411|NCT01193127|E1|Reported Event|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
200412|NCT01193114|B3|Baseline|Total|Total of all reporting groups
200413|NCT01193114|B2|Baseline|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200414|NCT01193114|B1|Baseline|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200415|NCT01193114|P2|Participant Flow|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200416|NCT01193114|P1|Participant Flow|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200417|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200418|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200419|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200420|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200421|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200422|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200423|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200424|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200425|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200426|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200427|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200428|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200429|NCT01193114|E2|Reported Event|Treatment as Usual|The Mothers were offered services provided through the family shelter.
200469|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
225923|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
200430|NCT01193114|E1|Reported Event|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
200431|NCT01193101|B5|Baseline|Total|Total of all reporting groups
200432|NCT01193101|B4|Baseline|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200433|NCT01193101|B3|Baseline|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200434|NCT01193101|B2|Baseline|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200435|NCT01193101|B1|Baseline|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200436|NCT01193101|P4|Participant Flow|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200437|NCT01193101|P3|Participant Flow|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200438|NCT01193101|P2|Participant Flow|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200439|NCT01193101|P1|Participant Flow|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200440|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200441|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200442|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200443|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200444|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200445|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200446|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200447|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200448|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200449|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200450|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200451|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200452|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200453|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200454|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200455|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200456|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200457|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200458|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200459|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200460|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200461|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200462|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200463|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200464|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200465|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200466|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200467|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200468|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200470|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200471|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200472|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200473|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200474|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200475|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200476|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200477|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200478|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200479|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200480|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200481|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200482|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200483|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200484|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200485|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200486|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200487|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200488|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200489|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200490|NCT01193101|E4|Reported Event|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
200491|NCT01193101|E3|Reported Event|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
200492|NCT01193101|E2|Reported Event|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200493|NCT01193101|E1|Reported Event|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
200494|NCT01193049|B1|Baseline|All Participants|All randomized participants
200495|NCT01193049|P2|Participant Flow|Placebo, Then Prednisone|Placebo in the first double blind treatment period and prednisone in the second double blind treatment period
200496|NCT01193049|P1|Participant Flow|Prednisone, Then Placebo|Prednisone in the first double blind treatment period and placebo in the second double blind treatment period
200497|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200498|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200499|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200500|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200501|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200502|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200503|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200504|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200505|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200506|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200507|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200508|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200509|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200510|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200511|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200512|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200513|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200514|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200515|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200516|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200517|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200520|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200521|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
200522|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
200523|NCT01193049|E2|Reported Event|Placebo|All participants who received at least one dose of placebo
200524|NCT01193049|E1|Reported Event|Prednisone|All participants who received at least one dose of prednisone
200525|NCT01192542|B1|Baseline|All Subjects|All subjects who enrolled in the study.
200526|NCT01192542|P2|Participant Flow|Enfilcon A Lens/Galyfilcon A Prototype Lens|The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
200527|NCT01192542|P1|Participant Flow|Galyfilcon A Prototype Lens/Enfilcon A Lens|The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.
200528|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
200529|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
200530|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel contact lens.
200531|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel contact lens.
200532|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
200533|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicon hydrogel contact lens.
200534|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
200535|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
200536|NCT01192542|E1|Reported Event|All Subjects|All subjects who exposed to the Investigation lenses.
200537|NCT01192516|B4|Baseline|Total|Total of all reporting groups
200538|NCT01192516|B3|Baseline|Arm 3|Usual care group
200539|NCT01192516|B2|Baseline|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
200540|NCT01192516|B1|Baseline|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
200541|NCT01192516|P3|Participant Flow|Usual Care Group|Participants receiving usual care
200542|NCT01192516|P2|Participant Flow|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200543|NCT01192516|P1|Participant Flow|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200544|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200545|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200546|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200547|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200548|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200549|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
200550|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200551|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200552|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200553|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200554|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200555|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200556|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200557|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200558|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200559|NCT01192516|O3|Outcome|Arm 3|Usual care group
200560|NCT01192516|O2|Outcome|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
200561|NCT01192516|O1|Outcome|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
200562|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200563|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200564|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200565|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200566|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200567|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200568|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
200979|NCT01191788|E2|Reported Event|Comparison|Treatment as Usual comparison condition
200569|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
200570|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
200571|NCT01192516|E3|Reported Event|Arm 3|Usual care group
200572|NCT01192516|E2|Reported Event|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
200573|NCT01192516|E1|Reported Event|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
200574|NCT01192412|B3|Baseline|Total|Total of all reporting groups
200575|NCT01192412|B2|Baseline|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
200576|NCT01192412|B1|Baseline|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
200577|NCT01192412|P2|Participant Flow|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
200578|NCT01192412|P1|Participant Flow|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
200579|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
200580|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
200581|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
200582|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
200583|NCT01192412|E2|Reported Event|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
200584|NCT01192412|E1|Reported Event|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
200585|NCT01192347|B1|Baseline|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200586|NCT01192347|P1|Participant Flow|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200587|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200588|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200589|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200590|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200591|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200592|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200593|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200594|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200595|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200596|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200597|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200598|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200599|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200600|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200601|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200602|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200603|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200604|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200605|NCT01192347|E1|Reported Event|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
200606|NCT01192295|B3|Baseline|Total|Total of all reporting groups
200607|NCT01192295|B2|Baseline|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200608|NCT01192295|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
200609|NCT01192295|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200610|NCT01192295|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
200611|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200612|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
200613|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200614|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
200615|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200616|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
200617|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200618|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
200619|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200620|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
200621|NCT01192295|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
200622|NCT01192295|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
200623|NCT01192282|B4|Baseline|Total|Total of all reporting groups
200624|NCT01192282|B3|Baseline|Persistent Cases|The warts presence after completion of treatment
200625|NCT01192282|B2|Baseline|Recurrent Cases|Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
200626|NCT01192282|B1|Baseline|New Cases|Newly diagnosed cases of genital warts
200627|NCT01192282|P1|Participant Flow|Number of Participants|Participants with Genital Warts
200628|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
200629|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
200630|NCT01192282|O3|Outcome|HIV Unknown|Participants who Refused HIV Testing
200631|NCT01192282|O2|Outcome|HIV Negative|Participants with HIV Negative
200632|NCT01192282|O1|Outcome|HIV Positive|Participants with HIV Positive
200633|NCT01192282|O2|Outcome|HPV DNA Negative|Participants with HPV DNA Negative
200634|NCT01192282|O1|Outcome|HPV DNA Positive|Participants with HPV DNA Positive
200635|NCT01192282|O3|Outcome|HIV Unknown|Number of participants who refused HIV Testing
200636|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
200637|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
200638|NCT01192282|E3|Reported Event|HIV Unknown|Participants with Genital Warts whom HIV Status was Unknown
200639|NCT01192282|E2|Reported Event|HIV Negative|Participants with Genital Warts who were HIV Negative
200640|NCT01192282|E1|Reported Event|HIV Positive|Participants with Genital Warts who were HIV Positive
200641|NCT01192204|B3|Baseline|Total|Total of all reporting groups
200642|NCT01192204|B2|Baseline|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200643|NCT01192204|B1|Baseline|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200644|NCT01192204|P2|Participant Flow|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200645|NCT01192204|P1|Participant Flow|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200646|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200647|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200648|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200649|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months."
200650|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200651|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
200652|NCT01192204|E2|Reported Event|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
200653|NCT01192204|E1|Reported Event|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
200654|NCT01192191|B3|Baseline|Total|Total of all reporting groups
200655|NCT01192191|B2|Baseline|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200656|NCT01192191|B1|Baseline|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200657|NCT01192191|P2|Participant Flow|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200658|NCT01192191|P1|Participant Flow|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200659|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200660|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200661|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200662|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200663|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200664|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200665|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200666|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200667|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200668|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200669|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200670|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200671|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200672|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200673|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200674|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200675|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200676|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200677|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200678|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200679|NCT01192191|E2|Reported Event|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
200680|NCT01192191|E1|Reported Event|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
200681|NCT01192178|B3|Baseline|Total|Total of all reporting groups
200682|NCT01192178|B2|Baseline|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200683|NCT01192178|B1|Baseline|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
200684|NCT01192178|P2|Participant Flow|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200685|NCT01192178|P1|Participant Flow|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
200686|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200687|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200688|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200689|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200690|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200691|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200692|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200693|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200694|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200695|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200696|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200697|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200698|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200699|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200700|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200701|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
200702|NCT01192178|E2|Reported Event|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
200703|NCT01192178|E1|Reported Event|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
200704|NCT01192152|B1|Baseline|All Enrolled and Treated Participants|
200705|NCT01192152|P2|Participant Flow|Treatment Sequence BA|Treatment B (period 1):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment A (period 2): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2.
200706|NCT01192152|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions; Treatment B (period 2):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment C (period 3): FDC tablet (5 mg saxa + 1000 mg metformin XR), once daily for 4 days, under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2. There was no washout between Periods 2 and 3.
200707|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200708|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200709|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200710|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200711|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200712|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200713|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200714|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200715|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200716|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200717|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200718|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200719|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200720|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200721|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200722|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200723|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200724|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200725|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200726|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
203625|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
200727|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200728|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200729|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200730|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200731|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200732|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200733|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200734|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200735|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200736|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200737|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200738|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200739|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200740|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200741|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200742|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200743|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200744|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200745|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200746|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200747|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200748|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200749|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200750|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200751|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200752|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200753|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200754|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200755|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200756|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200757|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200758|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200759|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200760|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200761|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200762|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200763|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200764|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200765|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200766|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200767|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200768|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200769|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200770|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200771|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200772|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200773|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200774|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200775|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200776|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200777|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200778|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200779|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200780|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200781|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200782|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200783|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200784|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200785|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200786|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200787|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200788|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200789|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200790|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200791|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200792|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200793|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200794|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200795|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200796|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200797|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200798|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200799|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200800|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200801|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200802|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200803|NCT01192152|E3|Reported Event|Saxa 5mg/500mg Metformin, Fed 4 Days|FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
200804|NCT01192152|E2|Reported Event|Saxa 5mg/1000mg Metformin, Fed|Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
200805|NCT01192152|E1|Reported Event|Saxa 5mg + 2x500mg Metformin, Fed|5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
200806|NCT01192139|B1|Baseline|All Enrolled and Treated Participants|
200807|NCT01192139|P6|Participant Flow|Treatment Sequence CBA|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
200808|NCT01192139|P5|Participant Flow|Treatment Sequence CAB|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
200809|NCT01192139|P4|Participant Flow|Treatment Sequence BCA|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
200810|NCT01192139|P3|Participant Flow|Treatment Sequence BAC|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
200811|NCT01192139|P2|Participant Flow|Treatment Sequence ACB|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
200812|NCT01192139|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
200813|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200814|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200815|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200816|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200817|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200818|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200819|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200820|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200821|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200822|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200823|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200824|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200825|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200826|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200827|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200828|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200829|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200830|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200831|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200832|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200833|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200834|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200835|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200836|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200837|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200838|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200839|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200840|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200841|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200842|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200843|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200844|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200845|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200846|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200847|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200848|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200849|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200850|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200851|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200852|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200853|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200854|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200855|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200856|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200857|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200858|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200859|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200860|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200861|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200862|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200863|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200864|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200865|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200866|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200867|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200868|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200869|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200870|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200871|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200872|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200873|NCT01192139|E3|Reported Event|Treatment B|Fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
200874|NCT01192139|E2|Reported Event|Treatment C|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
200875|NCT01192139|E1|Reported Event|Treatment A|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
200876|NCT01192126|B1|Baseline|Overall Study|All eligible subjects
200877|NCT01192126|P2|Participant Flow|J & J Acuvue Moist, Then B & L Daily Disposable Lens|Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
200878|NCT01192126|P1|Participant Flow|B & L Daily Disposable Lens, Then J & J Acuvue Moist|Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
200879|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200880|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200881|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200882|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200883|NCT01192126|E2|Reported Event|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200884|NCT01192126|E1|Reported Event|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
200885|NCT01192022|B5|Baseline|Total|Total of all reporting groups
200886|NCT01192022|B4|Baseline|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
203626|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
200887|NCT01192022|B3|Baseline|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200888|NCT01192022|B2|Baseline|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200889|NCT01192022|B1|Baseline|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200890|NCT01192022|P5|Participant Flow|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200891|NCT01192022|P4|Participant Flow|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200892|NCT01192022|P3|Participant Flow|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200893|NCT01192022|P2|Participant Flow|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200894|NCT01192022|P1|Participant Flow|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200895|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200896|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200897|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200898|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200899|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200900|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200901|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200902|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200903|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200904|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200905|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200906|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200907|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200908|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200909|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200910|NCT01192022|E4|Reported Event|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200911|NCT01192022|E3|Reported Event|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200912|NCT01192022|E2|Reported Event|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200913|NCT01192022|E1|Reported Event|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
200914|NCT01191944|B3|Baseline|Total|Total of all reporting groups
200915|NCT01191944|B2|Baseline|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200916|NCT01191944|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200917|NCT01191944|P2|Participant Flow|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200918|NCT01191944|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200919|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200920|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200921|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200922|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200923|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200924|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200925|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200926|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200927|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200928|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200929|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200930|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200931|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200932|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200933|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200934|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200935|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200936|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200937|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200938|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200980|NCT01191788|E1|Reported Event|Group CBT|Clients received up to 16 sessions of group CBT for depression
200939|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200940|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200941|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200942|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200943|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200944|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200945|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200946|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200947|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200948|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200949|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200950|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200951|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200952|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200953|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200954|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200955|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200956|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200957|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200958|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200959|NCT01191944|E2|Reported Event|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
200960|NCT01191944|E1|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
200961|NCT01191827|B3|Baseline|Total|Total of all reporting groups
200962|NCT01191827|B2|Baseline|Clozapine|Patients with schizophrenia treated with clozapine
200963|NCT01191827|B1|Baseline|Risperidone|Patients with schizophrenia treated with risperidone
200964|NCT01191827|P2|Participant Flow|Clozapine|Patients with schizophrenia treated with clozapine
200965|NCT01191827|P1|Participant Flow|Risperidone|Patients with schizophrenia treated with risperidone
200966|NCT01191827|O2|Outcome|Clozapine|Patients with schizophrenia treated with clozapine
200967|NCT01191827|O1|Outcome|Risperidone|Patients with schizophrenia treated with risperidone
200968|NCT01191827|E2|Reported Event|Clozapine|Patients with schizophrenia treated with clozapine
200969|NCT01191827|E1|Reported Event|Risperidone|Patients with schizophrenia treated with risperidone
200970|NCT01191788|B3|Baseline|Total|Total of all reporting groups
200971|NCT01191788|B2|Baseline|Comparison|Treatment as Usual comparison condition
200972|NCT01191788|B1|Baseline|Group CBT|Clients received up to 16 sessions of group CBT for depression
200973|NCT01191788|P2|Participant Flow|Comparison|Treatment as Usual comparison condition
200974|NCT01191788|P1|Participant Flow|Group CBT|Clients received up to 16 sessions of group CBT for depression
200975|NCT01191788|O2|Outcome|Comparison|Usual care.
200976|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
200977|NCT01191788|O2|Outcome|Comparison|Usual care
200978|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
200982|NCT01191762|B2|Baseline|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
200983|NCT01191762|B1|Baseline|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
200984|NCT01191762|P2|Participant Flow|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
200985|NCT01191762|P1|Participant Flow|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
200986|NCT01191762|O2|Outcome|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
200987|NCT01191762|O1|Outcome|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
200988|NCT01191762|E2|Reported Event|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
200989|NCT01191762|E1|Reported Event|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
200990|NCT01191736|B8|Baseline|Total|Total of all reporting groups
200991|NCT01191736|B7|Baseline|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
200992|NCT01191736|B6|Baseline|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
200993|NCT01191736|B5|Baseline|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
200994|NCT01191736|B4|Baseline|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
200995|NCT01191736|B3|Baseline|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
200996|NCT01191736|B2|Baseline|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
200997|NCT01191736|B1|Baseline|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
200998|NCT01191736|P7|Participant Flow|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
200999|NCT01191736|P6|Participant Flow|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
201000|NCT01191736|P5|Participant Flow|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
201001|NCT01191736|P4|Participant Flow|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
201002|NCT01191736|P3|Participant Flow|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
201003|NCT01191736|P2|Participant Flow|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
201004|NCT01191736|P1|Participant Flow|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
201005|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
201006|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
201007|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
201008|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
201009|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
201010|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
201011|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
201012|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
201013|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
201014|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
201015|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
201016|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
201017|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
201018|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
201019|NCT01191736|E7|Reported Event|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
201020|NCT01191736|E6|Reported Event|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
201021|NCT01191736|E5|Reported Event|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
201022|NCT01191736|E4|Reported Event|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
201023|NCT01191736|E3|Reported Event|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
201024|NCT01191736|E2|Reported Event|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
201025|NCT01191736|E1|Reported Event|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
201026|NCT01191723|B1|Baseline|All Subjects|All subjects enrolled in the study.
201027|NCT01191723|P6|Participant Flow|Treatment C, Then B, Then A|Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
201028|NCT01191723|P5|Participant Flow|Treatment C, Then A, Then B|"Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
201029|NCT01191723|P4|Participant Flow|Treatment B, Then C, Then A|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
201030|NCT01191723|P3|Participant Flow|Treatment B, Then A, Then C|"Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment C = inhaler placebo and placebo capsules at Visit 4."
201031|NCT01191723|P2|Participant Flow|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
201032|NCT01191723|P1|Participant Flow|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4."
201033|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
201034|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
201035|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
201036|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
201037|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
201038|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
201039|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
201040|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
201041|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
201042|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
201043|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
201044|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
201045|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
201046|NCT01191723|E3|Reported Event|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
201047|NCT01191723|E2|Reported Event|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
201048|NCT01191723|E1|Reported Event|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules
201049|NCT01191476|B4|Baseline|Total|Total of all reporting groups
201050|NCT01191476|B3|Baseline|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
201051|NCT01191476|B2|Baseline|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
201052|NCT01191476|B1|Baseline|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
201053|NCT01191476|P3|Participant Flow|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
201054|NCT01191476|P2|Participant Flow|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
201055|NCT01191476|P1|Participant Flow|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
201056|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
201057|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
201058|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
201059|NCT01191476|O3|Outcome|Propofol Induction and Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
201060|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
201061|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
201062|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
201063|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
201064|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
201065|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
201066|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
201067|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
201068|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
201069|NCT01191476|O2|Outcome|Propofol|IV Propofol for induction and maintenance of anesthesia
201070|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
201071|NCT01191476|E3|Reported Event|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
201072|NCT01191476|E2|Reported Event|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
201073|NCT01191476|E1|Reported Event|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
201074|NCT01191411|B4|Baseline|Total|Total of all reporting groups
201075|NCT01191411|B3|Baseline|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
201076|NCT01191411|B2|Baseline|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
201077|NCT01191411|B1|Baseline|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
201078|NCT01191411|P3|Participant Flow|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
201079|NCT01191411|P2|Participant Flow|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
201080|NCT01191411|P1|Participant Flow|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
201081|NCT01191411|O3|Outcome|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
201082|NCT01191411|O2|Outcome|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
201083|NCT01191411|O1|Outcome|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
201084|NCT01191411|E3|Reported Event|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
201085|NCT01191411|E2|Reported Event|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
201120|NCT01191268|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201121|NCT01191268|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
203627|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
201086|NCT01191411|E1|Reported Event|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
201087|NCT01191398|B4|Baseline|Total|Total of all reporting groups
201088|NCT01191398|B3|Baseline|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201089|NCT01191398|B2|Baseline|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201090|NCT01191398|B1|Baseline|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
201091|NCT01191398|P3|Participant Flow|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201092|NCT01191398|P2|Participant Flow|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201093|NCT01191398|P1|Participant Flow|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
201094|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201095|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201096|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
201097|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201098|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201099|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
201100|NCT01191398|E3|Reported Event|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201101|NCT01191398|E2|Reported Event|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
201102|NCT01191398|E1|Reported Event|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
201103|NCT01191320|B4|Baseline|Total|Total of all reporting groups
201104|NCT01191320|B3|Baseline|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201105|NCT01191320|B2|Baseline|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201106|NCT01191320|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
201107|NCT01191320|P3|Participant Flow|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201108|NCT01191320|P2|Participant Flow|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201109|NCT01191320|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
201110|NCT01191320|O3|Outcome|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201111|NCT01191320|O2|Outcome|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201112|NCT01191320|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
201113|NCT01191320|E3|Reported Event|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201114|NCT01191320|E2|Reported Event|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
201115|NCT01191320|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
201116|NCT01191268|B4|Baseline|Total|Total of all reporting groups
201117|NCT01191268|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201118|NCT01191268|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201119|NCT01191268|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
203628|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
201122|NCT01191268|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201123|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201124|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201125|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201126|NCT01191268|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201127|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201128|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201129|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201130|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201131|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201132|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201133|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201134|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201135|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201136|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201137|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201138|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201139|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201140|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201141|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201142|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201143|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201144|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201145|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201146|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201147|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201345|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201148|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201149|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201150|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201151|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201152|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201153|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201154|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201155|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201156|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201157|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201158|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201159|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201160|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201161|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201162|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201163|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201164|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201165|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201166|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201167|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201168|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201169|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201170|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201171|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201172|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201173|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201346|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
203629|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
201174|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201175|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201176|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201177|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201178|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201179|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201180|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201181|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201182|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201183|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201184|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201185|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201186|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201187|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201188|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201189|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201190|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201191|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201192|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201193|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201194|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201195|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201196|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201197|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201198|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201199|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201228|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201200|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201201|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201202|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201203|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201204|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201205|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201206|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201207|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201208|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201209|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201210|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201211|NCT01191268|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201212|NCT01191268|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201213|NCT01191268|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
201214|NCT01191255|B5|Baseline|Total|Total of all reporting groups
201215|NCT01191255|B4|Baseline|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201216|NCT01191255|B3|Baseline|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201217|NCT01191255|B2|Baseline|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201218|NCT01191255|B1|Baseline|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201219|NCT01191255|P4|Participant Flow|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201220|NCT01191255|P3|Participant Flow|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201221|NCT01191255|P2|Participant Flow|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201222|NCT01191255|P1|Participant Flow|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201223|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201224|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201225|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201226|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201227|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201229|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201230|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201231|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201232|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201233|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201234|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201235|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201236|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201237|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201238|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201239|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201240|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
201241|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
201242|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
201243|NCT01191255|E4|Reported Event|Placebo (EAP)|Efficacy Assessment Period (Week 52-56)
201244|NCT01191255|E3|Reported Event|KRX-0502 (EAP)|Efficacy Assessment Period (Week 52-56)
201245|NCT01191255|E2|Reported Event|Active Control (SAP)|Safety Assessment Period (Week 1-52)
201246|NCT01191255|E1|Reported Event|KRX-0502 (SAP)|Safety Assessment Period (Week 1-52)
201247|NCT01191242|B1|Baseline|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201248|NCT01191242|P1|Participant Flow|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201249|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201250|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201251|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201252|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201253|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201254|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201255|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201256|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201257|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201258|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201259|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201260|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201261|NCT01191242|E1|Reported Event|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
201274|NCT01191086|P1|Participant Flow|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
201275|NCT01191086|O1|Outcome|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
201276|NCT01191086|E1|Reported Event|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
201277|NCT01190891|B3|Baseline|Total|Total of all reporting groups
201262|NCT01191190|B1|Baseline|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201263|NCT01191190|P1|Participant Flow|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201264|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201265|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201266|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201267|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201268|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201269|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201270|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201271|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201272|NCT01191190|E1|Reported Event|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
201273|NCT01191086|B1|Baseline|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
225924|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
201278|NCT01190891|B2|Baseline|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
201279|NCT01190891|B1|Baseline|Manual Physical Therapy|Manual Physical Therapy: Same as arm description
201280|NCT01190891|P2|Participant Flow|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
201281|NCT01190891|P1|Participant Flow|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
201282|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
201283|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
201284|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
201285|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
201286|NCT01190891|E2|Reported Event|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
201287|NCT01190891|E1|Reported Event|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
201288|NCT01190878|B5|Baseline|Total|Total of all reporting groups
201289|NCT01190878|B4|Baseline|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
201290|NCT01190878|B3|Baseline|Xibrom BID|Xibrom™: Xibrom dosed BID
201291|NCT01190878|B2|Baseline|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
201292|NCT01190878|B1|Baseline|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
201293|NCT01190878|P4|Participant Flow|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle dosed BID
201294|NCT01190878|P3|Participant Flow|Xibrom BID|Xibrom™: 0.09% bromfenac dosed BID
201295|NCT01190878|P2|Participant Flow|ISV-303 QD|ISV-303: 0.075% bromfenac in DuraSite dosed QD
201296|NCT01190878|P1|Participant Flow|ISV-303 BID|ISV-303: 0.075% bromfenac in DuraSite dosed BID
201297|NCT01190878|O4|Outcome|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
201298|NCT01190878|O3|Outcome|Xibrom BID|Xibrom™: Xibrom dosed BID
201299|NCT01190878|O2|Outcome|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
201300|NCT01190878|O1|Outcome|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
201301|NCT01190878|E4|Reported Event|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
201302|NCT01190878|E3|Reported Event|Xibrom BID|Xibrom™: Xibrom dosed BID
201303|NCT01190878|E2|Reported Event|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
201304|NCT01190878|E1|Reported Event|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
201305|NCT01190865|B1|Baseline|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
201306|NCT01190865|P1|Participant Flow|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
201307|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
201308|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
201309|NCT01190865|E1|Reported Event|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
201310|NCT01190839|B3|Baseline|Total|Total of all reporting groups
201311|NCT01190839|B2|Baseline|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
201312|NCT01190839|B1|Baseline|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
201313|NCT01190839|P2|Participant Flow|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
201314|NCT01190839|P1|Participant Flow|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
201315|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
201316|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
201317|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
201318|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
201319|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
201320|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
201321|NCT01190839|E4|Reported Event|First Infliximab 5 mg/kg Then Infliximab 10 mg/kg|Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
201322|NCT01190839|E3|Reported Event|First Placebo Then Infliximab 5 mg/kg|Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.
201323|NCT01190839|E2|Reported Event|Infliximab 5 mg/kg|Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
201324|NCT01190839|E1|Reported Event|Placebo|Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
201325|NCT01190813|B3|Baseline|Total|Total of all reporting groups
201326|NCT01190813|B2|Baseline|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201327|NCT01190813|B1|Baseline|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201328|NCT01190813|P2|Participant Flow|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201329|NCT01190813|P1|Participant Flow|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201330|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201331|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201332|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201333|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201334|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201335|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201336|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201337|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201338|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201339|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201340|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201341|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201342|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201343|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201344|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
225925|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
201347|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201348|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201349|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201350|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201351|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201352|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201353|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201354|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201355|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201356|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201357|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201358|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201359|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201360|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201361|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201362|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201363|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201364|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201365|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201366|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201367|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201368|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201369|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201370|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201371|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201372|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201373|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201374|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201375|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201376|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201377|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201378|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201379|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201380|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201381|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201382|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201383|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201384|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201385|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201386|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201431|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201387|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201388|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201389|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201390|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201391|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201392|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201393|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201394|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201395|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201396|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201397|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201398|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201399|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201400|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201401|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201402|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201403|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201404|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201405|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201406|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201407|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201408|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201409|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201410|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201411|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201412|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201413|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201414|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201415|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201416|NCT01190813|E2|Reported Event|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
201417|NCT01190813|E1|Reported Event|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
201418|NCT01190566|B3|Baseline|Total|Total of all reporting groups
201419|NCT01190566|B2|Baseline|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
201420|NCT01190566|B1|Baseline|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
201421|NCT01190566|P2|Participant Flow|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
201422|NCT01190566|P1|Participant Flow|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
201423|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201424|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201425|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201426|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201427|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201428|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201429|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201430|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201432|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201433|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201434|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201435|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201436|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201437|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
201438|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201439|NCT01190566|O1|Outcome|Pathologic Response to Chemotherapy|Degree of pathologic response to the neoadjuvant chemotherapy
201440|NCT01190566|E2|Reported Event|Non-pCR|the presence of invasive tumor cells after surgery
201441|NCT01190566|E1|Reported Event|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
201442|NCT01190527|B1|Baseline|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201443|NCT01190527|P1|Participant Flow|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201444|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201445|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201446|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201447|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201448|NCT01190527|E1|Reported Event|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
201449|NCT01190514|B1|Baseline|Entire Study Population|Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
201450|NCT01190514|P4|Participant Flow|DVS SR 50 mg Fasted (D) First|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201451|NCT01190514|P3|Participant Flow|DVS SR 25 mg*2 Fasted (C) First|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
201452|NCT01190514|P2|Participant Flow|DVS SR 50 mg Fed (B) First|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201453|NCT01190514|P1|Participant Flow|DVS SR 25 mg*2 Fed (A) First|Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
201454|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201455|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201456|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201457|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201458|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201459|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201460|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201461|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201462|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201463|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201464|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201465|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201466|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201467|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201468|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201469|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201470|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201471|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201472|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201473|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201474|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201475|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
201476|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201477|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
201478|NCT01190514|E4|Reported Event|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
201479|NCT01190514|E3|Reported Event|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
201480|NCT01190514|E2|Reported Event|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
201481|NCT01190514|E1|Reported Event|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
201482|NCT01190436|B1|Baseline|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201483|NCT01190436|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201484|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
201485|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201486|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201487|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201488|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201489|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201490|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201491|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201492|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201493|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201494|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
201495|NCT01190436|E1|Reported Event|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
201496|NCT01190306|B3|Baseline|Total|Total of all reporting groups
201497|NCT01190306|B2|Baseline|Sham Control|Eyes in the control group will be treated with riboflavin only.
201498|NCT01190306|B1|Baseline|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
201499|NCT01190306|P2|Participant Flow|Sham Control|Eyes in the control group will be treated with riboflavin only.
201500|NCT01190306|P1|Participant Flow|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
201501|NCT01190306|O2|Outcome|Sham Control|Eyes in the control group will be treated with riboflavin only.
201502|NCT01190306|O1|Outcome|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
201503|NCT01190306|E2|Reported Event|Sham Control|Eyes in the control group will be treated with riboflavin only.
201504|NCT01190306|E1|Reported Event|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
201505|NCT01190267|B3|Baseline|Total|Total of all reporting groups
201506|NCT01190267|B2|Baseline|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
201507|NCT01190267|B1|Baseline|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
201508|NCT01190267|P2|Participant Flow|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
201509|NCT01190267|P1|Participant Flow|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
201510|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
201511|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
201512|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
201513|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
201514|NCT01190267|E2|Reported Event|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
201515|NCT01190267|E1|Reported Event|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
201516|NCT01190254|B4|Baseline|Total|Total of all reporting groups
201517|NCT01190254|B3|Baseline|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201518|NCT01190254|B2|Baseline|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201519|NCT01190254|B1|Baseline|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201520|NCT01190254|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201521|NCT01190254|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201522|NCT01190254|P1|Participant Flow|Placebo|Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks
201523|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201524|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201525|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201526|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201527|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201528|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201529|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201530|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201531|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201722|NCT01190098|B3|Baseline|Total|Total of all reporting groups
201723|NCT01190098|B2|Baseline|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201532|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201533|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201534|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201535|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201536|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201537|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201538|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201539|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201540|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201541|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201542|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201543|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201544|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201545|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201546|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201547|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201548|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201549|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201550|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201551|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201552|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201553|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201554|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201555|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201556|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201557|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201558|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201559|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201560|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201561|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201562|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201563|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201564|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201565|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201566|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201567|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201568|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201569|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201570|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201571|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201572|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201573|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201574|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201575|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201576|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201577|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201578|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201579|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201580|NCT01190254|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
201581|NCT01190254|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
201582|NCT01190254|E1|Reported Event|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
201583|NCT01190215|B3|Baseline|Total|Total of all reporting groups
201584|NCT01190215|B2|Baseline|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201585|NCT01190215|B1|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201586|NCT01190215|P2|Participant Flow|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201587|NCT01190215|P1|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201588|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201589|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201590|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201591|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201592|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201593|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201594|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201595|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201596|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201597|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201598|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201599|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201600|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201601|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201602|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201603|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201604|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201605|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201606|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201607|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201608|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201609|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201610|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201611|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201612|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201613|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201614|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201615|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201616|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201617|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201618|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201619|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201620|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201621|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201811|NCT01189760|B4|Baseline|Total|Total of all reporting groups
225926|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
201622|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201623|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201624|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201625|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201626|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201627|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201628|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201629|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201630|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201631|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201632|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201633|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201634|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201635|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201636|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201637|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201638|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201639|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201640|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201641|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201642|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201643|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201644|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201645|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
202004|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
201646|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201647|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201648|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201649|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201650|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201651|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201652|NCT01190215|E2|Reported Event|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201653|NCT01190215|E1|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
201654|NCT01190150|B3|Baseline|Total|Total of all reporting groups
201655|NCT01190150|B2|Baseline|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
201656|NCT01190150|B1|Baseline|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
201657|NCT01190150|P2|Participant Flow|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
201658|NCT01190150|P1|Participant Flow|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
201659|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201660|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201661|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201662|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201663|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201664|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201665|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201666|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201667|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201668|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201669|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201670|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201671|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201672|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201673|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201674|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201675|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201676|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201677|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201678|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201679|NCT01190150|E2|Reported Event|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
201680|NCT01190150|E1|Reported Event|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
201681|NCT01190124|B4|Baseline|Total|Total of all reporting groups
201682|NCT01190124|B3|Baseline|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201683|NCT01190124|B2|Baseline|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201684|NCT01190124|B1|Baseline|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201685|NCT01190124|P3|Participant Flow|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201686|NCT01190124|P2|Participant Flow|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201687|NCT01190124|P1|Participant Flow|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201688|NCT01190124|O1|Outcome|Total|Total number of patients studied
201689|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201690|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201691|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201692|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201693|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201694|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201695|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201696|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201697|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201698|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201699|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201700|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
201701|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201702|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201703|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201704|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201705|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201706|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
201707|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201708|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201709|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201710|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201711|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201712|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201713|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201714|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201715|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201716|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201717|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201718|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201719|NCT01190124|E3|Reported Event|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
201720|NCT01190124|E2|Reported Event|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
201721|NCT01190124|E1|Reported Event|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
201724|NCT01190098|B1|Baseline|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201725|NCT01190098|P2|Participant Flow|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201726|NCT01190098|P1|Participant Flow|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201727|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201728|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201729|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201730|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201731|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201732|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201733|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201734|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201735|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201736|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201737|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201738|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201739|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201740|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201741|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201742|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201743|NCT01190098|E2|Reported Event|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
201744|NCT01190098|E1|Reported Event|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
201745|NCT01190085|B4|Baseline|Total|Total of all reporting groups
201746|NCT01190085|B3|Baseline|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201747|NCT01190085|B2|Baseline|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201748|NCT01190085|B1|Baseline|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201749|NCT01190085|P3|Participant Flow|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201750|NCT01190085|P2|Participant Flow|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201751|NCT01190085|P1|Participant Flow|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201752|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201753|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201754|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201755|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201756|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201757|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201758|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
225927|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
201759|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201760|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201761|NCT01190085|E3|Reported Event|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201762|NCT01190085|E2|Reported Event|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201763|NCT01190085|E1|Reported Event|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
201764|NCT01190007|B1|Baseline|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201765|NCT01190007|P1|Participant Flow|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201766|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201767|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201768|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201769|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201770|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201771|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201772|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201773|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201812|NCT01189760|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
202461|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
201774|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201775|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201776|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201777|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201778|NCT01190007|E1|Reported Event|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
201779|NCT01189890|B3|Baseline|Total|Total of all reporting groups
201780|NCT01189890|B2|Baseline|Glimepiride|Glimepiride 1-6 mg QD
201781|NCT01189890|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201782|NCT01189890|P2|Participant Flow|Glimepiride|Glimepiride 1-6 mg QD
201783|NCT01189890|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201784|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201785|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201786|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201787|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201788|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201789|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201790|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201791|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201792|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201793|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201794|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201795|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201796|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201797|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201798|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
201799|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201800|NCT01189890|E2|Reported Event|Glimepiride|Glimepiride 1-6 mg QD
201801|NCT01189890|E1|Reported Event|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
201802|NCT01189812|B3|Baseline|Total|Total of all reporting groups
201803|NCT01189812|B2|Baseline|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201804|NCT01189812|B1|Baseline|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201805|NCT01189812|P2|Participant Flow|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201806|NCT01189812|P1|Participant Flow|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201807|NCT01189812|O2|Outcome|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201808|NCT01189812|O1|Outcome|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201809|NCT01189812|E2|Reported Event|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201810|NCT01189812|E1|Reported Event|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
201813|NCT01189760|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201814|NCT01189760|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201815|NCT01189760|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201816|NCT01189760|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201817|NCT01189760|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201818|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201819|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201820|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201821|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201822|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201823|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201824|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201825|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201826|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201827|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201828|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201829|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201830|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201831|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201832|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201833|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201834|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201835|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201836|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201837|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201838|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201839|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201840|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201841|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201889|NCT01189604|B1|Baseline|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201842|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201843|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201844|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201845|NCT01189760|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201846|NCT01189760|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201847|NCT01189760|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
201848|NCT01189747|B3|Baseline|Total|Total of all reporting groups
201849|NCT01189747|B2|Baseline|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201850|NCT01189747|B1|Baseline|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201851|NCT01189747|P2|Participant Flow|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201852|NCT01189747|P1|Participant Flow|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201853|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201854|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201855|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201856|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201857|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201858|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201859|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201860|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201861|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201862|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201863|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201864|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201865|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201866|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201867|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201868|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201869|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201870|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201871|NCT01189747|E2|Reported Event|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
201872|NCT01189747|E1|Reported Event|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
201873|NCT01189617|B3|Baseline|Total|Total of all reporting groups
201874|NCT01189617|B2|Baseline|Female|Female Participants
201875|NCT01189617|B1|Baseline|Male|Male Participants
201876|NCT01189617|P2|Participant Flow|Female|Female Participants
201877|NCT01189617|P1|Participant Flow|Male|Male Participants
201878|NCT01189617|O2|Outcome|Female|Female Participants
201879|NCT01189617|O1|Outcome|Male|Male Participants
201880|NCT01189617|E2|Reported Event|Female|Female Participants
201881|NCT01189617|E1|Reported Event|Male|Male Participants
201882|NCT01189604|B8|Baseline|Total|Total of all reporting groups
201883|NCT01189604|B7|Baseline|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201884|NCT01189604|B6|Baseline|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201885|NCT01189604|B5|Baseline|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201886|NCT01189604|B4|Baseline|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201887|NCT01189604|B3|Baseline|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201888|NCT01189604|B2|Baseline|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201890|NCT01189604|P7|Participant Flow|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201891|NCT01189604|P6|Participant Flow|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201892|NCT01189604|P5|Participant Flow|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201893|NCT01189604|P4|Participant Flow|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201894|NCT01189604|P3|Participant Flow|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201895|NCT01189604|P2|Participant Flow|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201896|NCT01189604|P1|Participant Flow|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201897|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201898|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201899|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201900|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201901|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201902|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201903|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201904|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201905|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201906|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201907|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201908|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201909|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201910|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201911|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201912|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201913|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201914|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201915|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201916|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201917|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201918|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201919|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201920|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201921|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201922|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201923|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201924|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201925|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201926|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201927|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201928|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201929|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201930|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201931|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201932|NCT01189604|E7|Reported Event|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
201933|NCT01189604|E6|Reported Event|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
201934|NCT01189604|E5|Reported Event|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
201935|NCT01189604|E4|Reported Event|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
201936|NCT01189604|E3|Reported Event|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
201937|NCT01189604|E2|Reported Event|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
201938|NCT01189604|E1|Reported Event|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
201939|NCT01189500|B1|Baseline|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201940|NCT01189500|P1|Participant Flow|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201941|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201942|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201943|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201944|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201945|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201946|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201947|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201948|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201949|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201950|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201951|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201952|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201953|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201954|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201955|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201956|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201957|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201958|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201959|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201960|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201961|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201962|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201963|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201964|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201965|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201966|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
202003|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
201967|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201968|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201969|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201970|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201971|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201972|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201973|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201974|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201975|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201976|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201977|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201978|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201979|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201980|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201981|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201982|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201983|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201984|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201985|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201986|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201987|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201988|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201989|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201990|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201991|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201992|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201993|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201994|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201995|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
201996|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
201997|NCT01189500|E3|Reported Event|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
201998|NCT01189500|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28.
201999|NCT01189500|E1|Reported Event|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.
202000|NCT01189487|B1|Baseline|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202001|NCT01189487|P1|Participant Flow|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202002|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202462|NCT01188551|E4|Reported Event|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
202005|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202006|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202007|NCT01189487|E1|Reported Event|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
202008|NCT01189461|B1|Baseline|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202009|NCT01189461|P1|Participant Flow|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202010|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202011|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202012|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202013|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202014|NCT01189461|E1|Reported Event|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
202015|NCT01189435|B1|Baseline|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
202016|NCT01189435|P1|Participant Flow|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
202017|NCT01189435|O1|Outcome|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
202018|NCT01189435|E1|Reported Event|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
202019|NCT01189292|B3|Baseline|Total|Total of all reporting groups
202020|NCT01189292|B2|Baseline|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202021|NCT01189292|B1|Baseline|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202022|NCT01189292|P2|Participant Flow|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202023|NCT01189292|P1|Participant Flow|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202024|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202025|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202026|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202027|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202028|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202029|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202030|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202031|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202032|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202033|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202034|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
225928|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
202035|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202036|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202037|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202038|NCT01189292|E2|Reported Event|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
202039|NCT01189292|E1|Reported Event|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
202040|NCT01189279|B4|Baseline|Total|Total of all reporting groups
202041|NCT01189279|B3|Baseline|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202042|NCT01189279|B2|Baseline|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202043|NCT01189279|B1|Baseline|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202044|NCT01189279|P3|Participant Flow|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202045|NCT01189279|P2|Participant Flow|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202046|NCT01189279|P1|Participant Flow|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202047|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202048|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202049|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202050|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202051|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202052|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202053|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202054|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202055|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202056|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202057|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202058|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202059|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202060|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202061|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202062|NCT01189279|E3|Reported Event|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
202063|NCT01189279|E2|Reported Event|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
202064|NCT01189279|E1|Reported Event|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
202065|NCT01189240|B1|Baseline|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202066|NCT01189240|P3|Participant Flow|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202067|NCT01189240|P2|Participant Flow|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202068|NCT01189240|P1|Participant Flow|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202069|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202070|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202071|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202072|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202073|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202074|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202075|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202076|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202077|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202078|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202079|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202080|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202104|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
203630|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
202081|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202082|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202083|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202084|NCT01189240|O1|Outcome|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202085|NCT01189240|E1|Reported Event|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
202086|NCT01189227|B3|Baseline|Total|Total of all reporting groups
202087|NCT01189227|B2|Baseline|Perioperative Chemotherapy|Perioperative chemotherapy
202088|NCT01189227|B1|Baseline|Postoperative Chemotherapy|Postoperative chemotherapy
202089|NCT01189227|P2|Participant Flow|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
202090|NCT01189227|P1|Participant Flow|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
202091|NCT01189227|O2|Outcome|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
202092|NCT01189227|O1|Outcome|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
202093|NCT01189227|E2|Reported Event|Perioperative Chemotherapy|Perioperative chemotherapy
202094|NCT01189227|E1|Reported Event|Postoperative Chemotherapy|Postoperative chemotherapy
202095|NCT01189201|B1|Baseline|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
202096|NCT01189201|P1|Participant Flow|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
202097|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202098|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202099|NCT01189201|O2|Outcome|Empa Plus Linagliptin Indivdual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202100|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202101|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202102|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202103|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202105|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202106|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202107|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
202108|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202109|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
202110|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202111|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202112|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202113|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202114|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202115|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202116|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202117|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202118|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202119|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202120|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202121|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202122|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202123|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202124|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202125|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202126|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202127|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202128|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202129|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
202130|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202131|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202132|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202133|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
202134|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202135|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202136|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202137|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202138|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202139|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202140|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202141|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202142|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202143|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202144|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202145|NCT01189201|E4|Reported Event|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
202463|NCT01188551|E3|Reported Event|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
202146|NCT01189201|E3|Reported Event|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
202147|NCT01189201|E2|Reported Event|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
202148|NCT01189201|E1|Reported Event|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
202149|NCT01189136|B3|Baseline|Total|Total of all reporting groups
202150|NCT01189136|B2|Baseline|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202151|NCT01189136|B1|Baseline|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202152|NCT01189136|P2|Participant Flow|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202153|NCT01189136|P1|Participant Flow|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202154|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202155|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202156|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202157|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202158|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202159|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202160|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202161|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202162|NCT01189136|E2|Reported Event|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
202163|NCT01189136|E1|Reported Event|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
202164|NCT01189123|B3|Baseline|Total|Total of all reporting groups
202165|NCT01189123|B2|Baseline|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
202166|NCT01189123|B1|Baseline|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
202167|NCT01189123|P2|Participant Flow|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
202168|NCT01189123|P1|Participant Flow|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone~1 dose of vaccine was given IM"
202169|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
202170|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
202171|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
202172|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
202173|NCT01189123|E2|Reported Event|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
202174|NCT01189123|E1|Reported Event|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
202175|NCT01189110|B3|Baseline|Total|Total of all reporting groups
202176|NCT01189110|B2|Baseline|Arm 2|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
202177|NCT01189110|B1|Baseline|Arm 1|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
202178|NCT01189110|P2|Participant Flow|Arm 2|Placebo group- sham Stim Flex machine
202179|NCT01189110|P1|Participant Flow|Arm 1|Intervention- true Stim Flex treatment
202180|NCT01189110|O2|Outcome|Arm 2- Placebo|Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
202181|NCT01189110|O1|Outcome|Arm 1- Intervention|Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
202182|NCT01189110|E2|Reported Event|Arm 2- Placebo|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
202214|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
202183|NCT01189110|E1|Reported Event|Arm 1- Intervention|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
202184|NCT01189071|B3|Baseline|Total|Total of all reporting groups
202185|NCT01189071|B2|Baseline|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
202186|NCT01189071|B1|Baseline|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
202187|NCT01189071|P2|Participant Flow|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
202188|NCT01189071|P1|Participant Flow|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
202189|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
202190|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
202191|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
202192|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
202193|NCT01189071|E2|Reported Event|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
202194|NCT01189071|E1|Reported Event|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
202195|NCT01189032|B4|Baseline|Total|Total of all reporting groups
202196|NCT01189032|B3|Baseline|High Concentration|3% DE-089 ophthalmic solution
202197|NCT01189032|B2|Baseline|Low Concentration|1% DE-089 ophthalmic solution
202198|NCT01189032|B1|Baseline|Placebo|Placebo ophthalmic solution
202199|NCT01189032|P3|Participant Flow|High Concentration|3% DE-089 ophthalmic solution
202200|NCT01189032|P2|Participant Flow|Low Concentration|1% DE-089 ophthalmic solution
202201|NCT01189032|P1|Participant Flow|Placebo|Placebo ophthalmic solution
202202|NCT01189032|O3|Outcome|High Concentration|3% DE-089 ophthalmic solution
202203|NCT01189032|O2|Outcome|Low Concentration|1% DE-089 ophthalmic solution
202204|NCT01189032|O1|Outcome|Placebo|Placebo ophthalmic solution
202205|NCT01189032|E3|Reported Event|High Concentration|3% DE-089 ophthalmic solution
202206|NCT01189032|E2|Reported Event|Low Concentration|1% DE-089 ophthalmic solution
202207|NCT01189032|E1|Reported Event|Placebo|Placebo ophthalmic solution
202208|NCT01188967|B3|Baseline|Total|Total of all reporting groups
202209|NCT01188967|B2|Baseline|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
202210|NCT01188967|B1|Baseline|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
202211|NCT01188967|P2|Participant Flow|Placebo Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
202212|NCT01188967|P1|Participant Flow|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
202213|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
225929|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
202215|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
202216|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
202217|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
202218|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
202219|NCT01188967|O2|Outcome|GSK598809 Treatment Group|
202220|NCT01188967|O1|Outcome|Placebo Treatment Group|
202221|NCT01188967|E2|Reported Event|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
202222|NCT01188967|E1|Reported Event|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.
202223|NCT01188928|B5|Baseline|Total|Total of all reporting groups
202224|NCT01188928|B4|Baseline|Topical Suspension Vehicle|The topical suspension vehicle alone
202225|NCT01188928|B3|Baseline|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202226|NCT01188928|B2|Baseline|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202227|NCT01188928|B1|Baseline|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202228|NCT01188928|P4|Participant Flow|Topical Suspension Vehicle|The topical suspension vehicle alone
202229|NCT01188928|P3|Participant Flow|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202230|NCT01188928|P2|Participant Flow|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202231|NCT01188928|P1|Participant Flow|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202232|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
202233|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202234|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202235|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202236|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
202237|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202238|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202239|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202240|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
202241|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202242|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202243|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202244|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
202245|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202246|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202247|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202248|NCT01188928|E4|Reported Event|Topical Suspension Vehicle|The topical suspension vehicle alone
202249|NCT01188928|E3|Reported Event|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
202250|NCT01188928|E2|Reported Event|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
202251|NCT01188928|E1|Reported Event|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
202252|NCT01188811|B3|Baseline|Total|Total of all reporting groups
202253|NCT01188811|B2|Baseline|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202254|NCT01188811|B1|Baseline|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
202255|NCT01188811|P2|Participant Flow|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202256|NCT01188811|P1|Participant Flow|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
202257|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202258|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
203631|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
202259|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202260|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
202261|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202262|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
202263|NCT01188811|E2|Reported Event|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
202264|NCT01188811|E1|Reported Event|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
202265|NCT01188798|B3|Baseline|Total|Total of all reporting groups
202266|NCT01188798|B2|Baseline|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202267|NCT01188798|B1|Baseline|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Methotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202268|NCT01188798|P2|Participant Flow|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202269|NCT01188798|P1|Participant Flow|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202270|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin).~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202271|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202272|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202273|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202274|NCT01188798|E2|Reported Event|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202275|NCT01188798|E1|Reported Event|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
202276|NCT01188772|B5|Baseline|Total|Total of all reporting groups
202277|NCT01188772|B4|Baseline|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202278|NCT01188772|B3|Baseline|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202279|NCT01188772|B2|Baseline|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
203632|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
202280|NCT01188772|B1|Baseline|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202281|NCT01188772|P4|Participant Flow|Sofosbuvir 400 mg (Genotype 2/3)|Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
202282|NCT01188772|P3|Participant Flow|Placebo (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
202283|NCT01188772|P2|Participant Flow|Sofosbuvir 400 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
202284|NCT01188772|P1|Participant Flow|Sofosbuvir 200 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
202285|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202286|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202287|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202288|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202289|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202290|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202291|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202292|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202293|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202294|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202295|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202296|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202297|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202298|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202299|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202300|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202301|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202302|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202303|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202304|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202305|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
202306|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202307|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202308|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202309|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202310|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202311|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202312|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202313|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202314|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202315|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202316|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202317|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202318|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202319|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202320|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202321|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202322|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202323|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202324|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202325|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202326|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202327|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202328|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202329|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202330|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202331|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202332|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202333|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202334|NCT01188772|E4|Reported Event|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
202335|NCT01188772|E3|Reported Event|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202336|NCT01188772|E2|Reported Event|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202337|NCT01188772|E1|Reported Event|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
202338|NCT01188681|B5|Baseline|Total|Total of all reporting groups
202339|NCT01188681|B4|Baseline|Phase 2: Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202340|NCT01188681|B3|Baseline|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202341|NCT01188681|B2|Baseline|Phase 1: 20 mg/kg TRU-016|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202342|NCT01188681|B1|Baseline|Phase 1: 15 mg/kg TRU-016|"TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202343|NCT01188681|P4|Participant Flow|Phase 2 Bendamustine|Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
202344|NCT01188681|P3|Participant Flow|Phase 2 TRU-016 and Bendamustine|Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
202345|NCT01188681|P2|Participant Flow|Phase 1 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202346|NCT01188681|P1|Participant Flow|Phase 1 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202347|NCT01188681|O4|Outcome|Phase 1: 20 mg/kg TRU-016 +Bendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202348|NCT01188681|O3|Outcome|Phase 1: 15 mg/kg TRU-016 +Beendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202349|NCT01188681|O2|Outcome|Phase 2: Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202350|NCT01188681|O1|Outcome|Phase 2: TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202351|NCT01188681|O4|Outcome|Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202352|NCT01188681|O3|Outcome|TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202353|NCT01188681|O2|Outcome|Phase 1 20 mg/kg TRU-016|20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
202354|NCT01188681|O1|Outcome|Phase 1 15 mg/kg TRU-016|15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
202355|NCT01188681|E4|Reported Event|Phase 2:Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202356|NCT01188681|E3|Reported Event|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
202357|NCT01188681|E2|Reported Event|Phase 1: 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202358|NCT01188681|E1|Reported Event|Phase 1: 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
202359|NCT01188668|B1|Baseline|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202458|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
202459|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
225930|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
202360|NCT01188668|P1|Participant Flow|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202361|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202362|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202363|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202364|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202365|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202366|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202367|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202368|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202369|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202370|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202371|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202372|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202373|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202374|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202375|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202376|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202377|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202378|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202379|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202380|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202381|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202382|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202383|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202384|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202385|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202386|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202387|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202388|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202389|NCT01188668|E3|Reported Event|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
202390|NCT01188668|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).
202391|NCT01188668|E1|Reported Event|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
202392|NCT01188655|B1|Baseline|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
203633|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
202393|NCT01188655|P1|Participant Flow|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202394|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202395|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202396|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202397|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202398|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202399|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202400|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202401|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202402|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202403|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202404|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202405|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202406|NCT01188655|E1|Reported Event|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
202407|NCT01188603|B1|Baseline|Flibanserin|100mg Flibanserin administered orally once daily
202408|NCT01188603|P1|Participant Flow|Flibanserin|100mg Flibanserin administered orally once daily
202409|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
202410|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
202411|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
202412|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
202413|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
202414|NCT01188603|E1|Reported Event|Flibanserin|100mg Flibanserin administered orally once daily
202415|NCT01188577|B3|Baseline|Total|Total of all reporting groups
202416|NCT01188577|B2|Baseline|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
202460|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
202417|NCT01188577|B1|Baseline|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
202418|NCT01188577|P2|Participant Flow|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
202419|NCT01188577|P1|Participant Flow|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
202420|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202421|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202422|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202423|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202424|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202425|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202426|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202427|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202428|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202429|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202430|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202431|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202432|NCT01188577|E2|Reported Event|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
202433|NCT01188577|E1|Reported Event|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
202434|NCT01188564|B3|Baseline|Total|Total of all reporting groups
202435|NCT01188564|B2|Baseline|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
202436|NCT01188564|B1|Baseline|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
202437|NCT01188564|P2|Participant Flow|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
202438|NCT01188564|P1|Participant Flow|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
202439|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
202440|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
202441|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
202442|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
202443|NCT01188564|E2|Reported Event|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
202444|NCT01188564|E1|Reported Event|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
202445|NCT01188551|B5|Baseline|Total|Total of all reporting groups
202446|NCT01188551|B4|Baseline|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
202447|NCT01188551|B3|Baseline|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
202448|NCT01188551|B2|Baseline|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
202449|NCT01188551|B1|Baseline|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
202450|NCT01188551|P4|Participant Flow|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
202451|NCT01188551|P3|Participant Flow|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
202452|NCT01188551|P2|Participant Flow|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
202453|NCT01188551|P1|Participant Flow|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
202454|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
202455|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
202456|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
202457|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
202464|NCT01188551|E2|Reported Event|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
202465|NCT01188551|E1|Reported Event|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
202466|NCT01188538|B3|Baseline|Total|Total of all reporting groups
202467|NCT01188538|B2|Baseline|Benzoyl Peroxide (BPO) Gel|
202468|NCT01188538|B1|Baseline|Epiduo Gel|
202469|NCT01188538|P2|Participant Flow|Benzoyl Peroxide (BPO) Gel|
202470|NCT01188538|P1|Participant Flow|Epiduo Gel|
202471|NCT01188538|O2|Outcome|BPO Gel|BPO Gel Topical to the face, once daily application in the evening
202472|NCT01188538|O1|Outcome|Epiduo® Gel|Epiduo® Gel Topical to the face, once daily application in the evening
202473|NCT01188538|O2|Outcome|Benzoyl Peroxide (BPO) Gel|
202474|NCT01188538|O1|Outcome|Epiduo Gel|
202475|NCT01188538|E2|Reported Event|Benzoyl Peroxide (BPO) Gel|
202476|NCT01188538|E1|Reported Event|Epiduo Gel|
202477|NCT01188499|B6|Baseline|Total|Total of all reporting groups
202478|NCT01188499|B5|Baseline|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202479|NCT01188499|B4|Baseline|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202480|NCT01188499|B3|Baseline|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202481|NCT01188499|B2|Baseline|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202482|NCT01188499|B1|Baseline|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202483|NCT01188499|P5|Participant Flow|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202484|NCT01188499|P4|Participant Flow|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202485|NCT01188499|P3|Participant Flow|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202486|NCT01188499|P2|Participant Flow|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202487|NCT01188499|P1|Participant Flow|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202488|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202489|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202490|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202514|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
203634|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
202491|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202492|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202493|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202494|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202495|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202496|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202497|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202498|NCT01188499|E5|Reported Event|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202499|NCT01188499|E4|Reported Event|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
202500|NCT01188499|E3|Reported Event|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202501|NCT01188499|E2|Reported Event|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202502|NCT01188499|E1|Reported Event|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
202503|NCT01188343|B4|Baseline|Total|Total of all reporting groups
202504|NCT01188343|B3|Baseline|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202505|NCT01188343|B2|Baseline|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202506|NCT01188343|B1|Baseline|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202507|NCT01188343|P3|Participant Flow|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
202508|NCT01188343|P2|Participant Flow|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202509|NCT01188343|P1|Participant Flow|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202510|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202511|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202512|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202513|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202515|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202516|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202517|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202518|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202519|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202520|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202521|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202522|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202523|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
202524|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202525|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202526|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
202527|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202528|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202529|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
202530|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202531|NCT01188343|E3|Reported Event|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
202532|NCT01188343|E2|Reported Event|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
202533|NCT01188343|E1|Reported Event|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
202534|NCT01188226|B1|Baseline|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
202535|NCT01188226|P1|Participant Flow|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
202536|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202537|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202538|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202539|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202540|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202541|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202542|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202543|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202544|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202545|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202546|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202547|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202548|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202549|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202550|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202551|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202552|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202553|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202554|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
202555|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
202556|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
202557|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202558|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202559|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202560|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202561|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202562|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
202563|NCT01188226|O1|Outcome|Participants With Nano Hybrid Composite Dentures|Denture teeth are made of nano hybrid composite material
202564|NCT01188226|O2|Outcome|Lower Denture|Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
202565|NCT01188226|O1|Outcome|Upper Denture|Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
202566|NCT01188226|O2|Outcome|Lower Denture|Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
202567|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
202568|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
202569|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
202570|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
202571|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
202572|NCT01188226|E1|Reported Event|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
202573|NCT01188109|B1|Baseline|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
202574|NCT01188109|P1|Participant Flow|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
202575|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
202576|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
202577|NCT01188109|E1|Reported Event|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
202578|NCT01187953|B3|Baseline|Total|Total of all reporting groups
202579|NCT01187953|B2|Baseline|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
202580|NCT01187953|B1|Baseline|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
202581|NCT01187953|P2|Participant Flow|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
202582|NCT01187953|P1|Participant Flow|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
202583|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
202584|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
202585|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
202586|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
202587|NCT01187953|E2|Reported Event|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
202588|NCT01187953|E1|Reported Event|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
202589|NCT01187914|B1|Baseline|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
202590|NCT01187914|P1|Participant Flow|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
202591|NCT01187914|O1|Outcome|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
202592|NCT01187914|E1|Reported Event|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
202593|NCT01187901|B3|Baseline|Total|Total of all reporting groups
202594|NCT01187901|B2|Baseline|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202595|NCT01187901|B1|Baseline|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202596|NCT01187901|P2|Participant Flow|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202597|NCT01187901|P1|Participant Flow|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202598|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202599|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202600|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202601|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202602|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202603|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202604|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202605|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202606|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202607|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202608|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202609|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202610|NCT01187901|E2|Reported Event|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
202611|NCT01187901|E1|Reported Event|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
202612|NCT01187550|B3|Baseline|Total|Total of all reporting groups
202613|NCT01187550|B2|Baseline|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202614|NCT01187550|B1|Baseline|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202615|NCT01187550|P2|Participant Flow|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202616|NCT01187550|P1|Participant Flow|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202617|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202618|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202619|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202656|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202620|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202621|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202622|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202623|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202624|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202625|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202626|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202627|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202628|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202629|NCT01187550|E2|Reported Event|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
202630|NCT01187550|E1|Reported Event|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
202631|NCT01187511|B3|Baseline|Total|Total of all reporting groups
202632|NCT01187511|B2|Baseline|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202633|NCT01187511|B1|Baseline|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202634|NCT01187511|P2|Participant Flow|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202635|NCT01187511|P1|Participant Flow|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202636|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202637|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202638|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202639|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202640|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202641|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202642|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202643|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202644|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202645|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202646|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202647|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202648|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202649|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202650|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202651|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202652|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202653|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202654|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202655|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202657|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202658|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202659|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202660|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202661|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202662|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202663|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202664|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202665|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202666|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202667|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202668|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202669|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202670|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202671|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202672|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202673|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202674|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202675|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202676|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202677|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202678|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202679|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202680|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202681|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202682|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202683|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202684|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202685|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202686|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202687|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202688|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202689|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202690|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202691|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202692|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202693|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202694|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202695|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202696|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202697|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202698|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202699|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202700|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202701|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202702|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202703|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202704|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202705|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202706|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202707|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202708|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202709|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202710|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202711|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202712|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202713|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202714|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202715|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202716|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202717|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202718|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202719|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202720|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202721|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202722|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202723|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202724|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202725|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202726|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202727|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202728|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202729|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202730|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202731|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202732|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202733|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202734|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202735|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202736|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202737|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202738|NCT01187511|E2|Reported Event|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
202739|NCT01187511|E1|Reported Event|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
202740|NCT01187498|B3|Baseline|Total|Total of all reporting groups
202741|NCT01187498|B2|Baseline|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202742|NCT01187498|B1|Baseline|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202743|NCT01187498|P2|Participant Flow|Drug Therapy|Individually titrated, extended-release oxybutynin chloride, 5-30mg
202744|NCT01187498|P1|Participant Flow|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202745|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202746|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202747|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202748|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202749|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202750|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202751|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202752|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202753|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202754|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202755|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202756|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202757|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202758|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202759|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202760|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202761|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202762|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202763|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202764|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202765|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202766|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202767|NCT01187498|E2|Reported Event|Drug Therapy|Individually titrated, extended release oxybutynin chloride
202768|NCT01187498|E1|Reported Event|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
202769|NCT01187433|B3|Baseline|Total|Total of all reporting groups
202770|NCT01187433|B2|Baseline|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202771|NCT01187433|B1|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202772|NCT01187433|P2|Participant Flow|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202773|NCT01187433|P1|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202774|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202775|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202776|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202777|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202778|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202779|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
203635|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
202780|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202781|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202782|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202783|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202784|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202785|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202786|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202787|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202788|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202789|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202790|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202791|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202792|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202793|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202794|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202795|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202796|NCT01187433|E2|Reported Event|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
202797|NCT01187433|E1|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
202798|NCT01187355|B3|Baseline|Total|Total of all reporting groups
202799|NCT01187355|B2|Baseline|Renu Fresh MPS|Multi-purpose contact lens solution
202800|NCT01187355|B1|Baseline|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202801|NCT01187355|P2|Participant Flow|Renu Fresh MPS|Multi-purpose contact lens solution
202802|NCT01187355|P1|Participant Flow|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202803|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
202804|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202805|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
202806|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202807|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
202808|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202809|NCT01187355|E2|Reported Event|Renu Fresh MPS|Multi-purpose contact lens solution
202810|NCT01187355|E1|Reported Event|Alcon MPDS|Multi-purpose disinfecting contact lens solution
202811|NCT01187043|B6|Baseline|Total|Total of all reporting groups
202812|NCT01187043|B5|Baseline|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202813|NCT01187043|B4|Baseline|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202814|NCT01187043|B3|Baseline|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202815|NCT01187043|B2|Baseline|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202816|NCT01187043|B1|Baseline|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202817|NCT01187043|P5|Participant Flow|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202818|NCT01187043|P4|Participant Flow|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202819|NCT01187043|P3|Participant Flow|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202820|NCT01187043|P2|Participant Flow|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202821|NCT01187043|P1|Participant Flow|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202822|NCT01187043|O5|Outcome|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202823|NCT01187043|O4|Outcome|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202824|NCT01187043|O3|Outcome|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202825|NCT01187043|O2|Outcome|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202826|NCT01187043|O1|Outcome|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202827|NCT01187043|E5|Reported Event|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202828|NCT01187043|E4|Reported Event|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202829|NCT01187043|E3|Reported Event|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202830|NCT01187043|E2|Reported Event|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202831|NCT01187043|E1|Reported Event|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
202832|NCT01187017|B1|Baseline|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
202833|NCT01187017|P1|Participant Flow|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
202834|NCT01187017|O1|Outcome|Response Rate at 6 Months|"Hematologic Response of Refractory Severe aplastic anemia (SAA) subjects to fludarabine and cyclophosphamide.~The refractory SAA subjects will receive fludarabine and cyclophosphamide. The blood counts will be evaluated to assess a hematologic response. The hematologic response will be defined as complete, partial or no response. The response will be evaluated at 6 months."
202835|NCT01187017|E1|Reported Event|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
202836|NCT01187004|B3|Baseline|Total|Total of all reporting groups
202837|NCT01187004|B2|Baseline|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
202838|NCT01187004|B1|Baseline|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
202839|NCT01187004|P2|Participant Flow|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
202840|NCT01187004|P1|Participant Flow|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
202841|NCT01187004|O2|Outcome|Control Group|patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
202842|NCT01187004|O1|Outcome|ICU-LOS in Patients Developing ALI|Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
202843|NCT01187004|O1|Outcome|Acute Lung Injury|Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
202844|NCT01187004|E2|Reported Event|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
202845|NCT01187004|E1|Reported Event|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
202846|NCT01186939|B1|Baseline|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
202847|NCT01186939|P1|Participant Flow|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
202848|NCT01186939|O1|Outcome|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
202849|NCT01186939|E1|Reported Event|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
202850|NCT01186848|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
202851|NCT01186848|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
202852|NCT01186848|O2|Outcome|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
202853|NCT01186848|O1|Outcome|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
202854|NCT01186848|E2|Reported Event|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
202855|NCT01186848|E1|Reported Event|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
202856|NCT01186796|B3|Baseline|Total|Total of all reporting groups
202857|NCT01186796|B2|Baseline|Saline Group|"Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202858|NCT01186796|B1|Baseline|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202859|NCT01186796|P2|Participant Flow|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202860|NCT01186796|P1|Participant Flow|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202861|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202862|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202863|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202864|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202865|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202866|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202867|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
225931|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
202868|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202869|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202870|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202871|NCT01186796|E2|Reported Event|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202872|NCT01186796|E1|Reported Event|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
202873|NCT01186744|B7|Baseline|Total|Total of all reporting groups
202874|NCT01186744|B6|Baseline|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
202875|NCT01186744|B5|Baseline|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202876|NCT01186744|B4|Baseline|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202877|NCT01186744|B3|Baseline|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202878|NCT01186744|B2|Baseline|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202879|NCT01186744|B1|Baseline|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202880|NCT01186744|P6|Participant Flow|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202881|NCT01186744|P5|Participant Flow|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202882|NCT01186744|P4|Participant Flow|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202883|NCT01186744|P3|Participant Flow|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202884|NCT01186744|P2|Participant Flow|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
202885|NCT01186744|P1|Participant Flow|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
202886|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202887|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202888|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202889|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202890|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202891|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202892|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202893|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202894|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202895|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202896|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202897|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202898|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202899|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202900|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202901|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202902|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202903|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202904|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202905|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202906|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202907|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202908|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202909|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202963|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202910|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202911|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202912|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202913|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202914|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202915|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202916|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202917|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202918|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202919|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202920|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202921|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202922|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202923|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202924|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202925|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202926|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202927|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202928|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202929|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202930|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202931|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202932|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202933|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202934|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202935|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
225932|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
202936|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202937|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202938|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202939|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202940|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202941|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202942|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202943|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202944|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202945|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202946|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202947|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202948|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202949|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202950|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202951|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202952|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202953|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202954|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202955|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202956|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202957|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202958|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202959|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202960|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202961|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202962|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202964|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202965|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202966|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202967|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202968|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202969|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202970|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202971|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202972|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202973|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202974|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202975|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202976|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202977|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202978|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202979|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202980|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202981|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202982|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202983|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202984|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202985|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202986|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202987|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202988|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202989|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202990|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202991|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202992|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202993|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202994|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202995|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
202996|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
202997|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
202998|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
202999|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203000|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203001|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203002|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203003|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203004|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203005|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203006|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203007|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203008|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203009|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203010|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203011|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203012|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203013|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203014|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203015|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203016|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
225933|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
203017|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203018|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203019|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203020|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203021|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203022|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203023|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203024|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203025|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203026|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203027|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203028|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203029|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203030|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203031|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203032|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203033|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203034|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203035|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203036|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203037|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203038|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203039|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203040|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203041|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203042|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203043|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203044|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203045|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203046|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203047|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203048|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203049|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203050|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203051|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203052|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203053|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203054|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203055|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203056|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203057|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203058|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203059|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203060|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203061|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203062|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203063|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203064|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203065|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203066|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203067|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203068|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203069|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203274|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203070|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203071|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203072|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203073|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203074|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203075|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203076|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203077|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203078|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203079|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203080|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203081|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203082|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203083|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203084|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203085|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203086|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203087|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203088|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203089|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203090|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203091|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203092|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203093|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203094|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203095|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
225934|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
203096|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203097|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203098|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203099|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203100|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203101|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203102|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203103|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203104|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203105|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203106|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203107|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203108|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203109|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203110|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203111|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203112|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203113|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203114|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203115|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203116|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203117|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203118|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203119|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203120|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203275|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203121|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203122|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203123|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203124|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203125|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203126|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203127|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203128|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203129|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203130|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203131|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203132|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203133|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203134|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203135|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203136|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
203137|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203138|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203139|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203140|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203141|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203142|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203143|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203144|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203145|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203146|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
203147|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203276|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203148|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203149|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203150|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203151|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203152|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203153|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203154|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203155|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203156|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203157|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203158|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203159|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203160|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203161|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203162|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203163|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203164|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203165|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203166|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203167|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203168|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203169|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203170|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203171|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203172|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203277|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203173|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203174|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203175|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203176|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203177|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203178|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203179|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203180|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203181|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203182|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203183|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203184|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203185|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203186|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203187|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203188|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203189|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203190|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203191|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203192|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203193|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203194|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203195|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203196|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203197|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203198|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203636|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
225935|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
203199|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203200|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203201|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203202|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203203|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203204|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203205|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203206|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203207|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203208|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203209|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203210|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203211|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203212|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203213|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203214|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203215|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203216|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203217|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203218|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203219|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203220|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203221|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203222|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203223|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203493|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203224|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203225|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203226|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203227|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203228|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203229|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203230|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203231|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203232|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203233|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203234|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203235|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203236|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203237|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203238|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203239|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203240|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203241|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203242|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203243|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203244|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203245|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203246|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203247|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203494|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203248|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203249|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203250|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203251|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203252|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203253|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203254|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203255|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203256|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203257|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203258|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203259|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203260|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203261|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203262|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203263|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203264|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203265|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203266|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203267|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203268|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203269|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203270|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203271|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203272|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203273|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203278|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203279|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203280|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203281|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203282|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203283|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203284|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203285|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203286|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203287|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203288|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203289|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203290|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203291|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203292|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203293|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
203294|NCT01186744|E6|Reported Event|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203295|NCT01186744|E5|Reported Event|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203296|NCT01186744|E4|Reported Event|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203297|NCT01186744|E3|Reported Event|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
203298|NCT01186744|E2|Reported Event|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
203299|NCT01186744|E1|Reported Event|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
203300|NCT01186705|B1|Baseline|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
203495|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203301|NCT01186705|P1|Participant Flow|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
203302|NCT01186705|O1|Outcome|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
203303|NCT01186705|E1|Reported Event|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
203304|NCT01186692|B1|Baseline|Enrolled Cohort|All subjects enrolled.
203305|NCT01186692|P1|Participant Flow|Enrolled|All subjects enrolled (n=131)
203306|NCT01186692|O1|Outcome|Implanted > 24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
203307|NCT01186692|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
203308|NCT01186692|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
203309|NCT01186692|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
203310|NCT01186692|O1|Outcome|Implanted >24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
203311|NCT01186692|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
203312|NCT01186562|B3|Baseline|Total|Total of all reporting groups
203313|NCT01186562|B2|Baseline|Placebo|Placebo: Placebo
203314|NCT01186562|B1|Baseline|Sitagliptin|Sitagliptin: 100 mg PO daily
203315|NCT01186562|P2|Participant Flow|Placebo|Placebo: Placebo
203316|NCT01186562|P1|Participant Flow|Sitagliptin|Sitagliptin: 100 mg PO daily
203317|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203318|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203319|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203320|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203321|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203322|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203323|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203324|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203325|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203326|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203327|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
203328|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
203329|NCT01186562|E2|Reported Event|Placebo|Placebo: Placebo
203330|NCT01186562|E1|Reported Event|Sitagliptin|Sitagliptin: 100 mg PO daily
203331|NCT01186458|B1|Baseline|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203332|NCT01186458|P1|Participant Flow|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203333|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203334|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203335|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203336|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203496|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203337|NCT01186458|E1|Reported Event|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
203338|NCT01186419|B3|Baseline|Total|Total of all reporting groups
203339|NCT01186419|B2|Baseline|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203340|NCT01186419|B1|Baseline|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203341|NCT01186419|P2|Participant Flow|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203342|NCT01186419|P1|Participant Flow|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203343|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
203344|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
203345|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
203346|NCT01186419|E2|Reported Event|SPD602 32 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203347|NCT01186419|E1|Reported Event|SPD602 16 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
203348|NCT01186406|B1|Baseline|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203349|NCT01186406|P1|Participant Flow|Gliadel, Radiation Therapy, Avastin, Temodar|"Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation~Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.~Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2)."
203350|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203376|NCT01185834|B1|Baseline|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
203377|NCT01185834|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
203535|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203351|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203352|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203353|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203354|NCT01186406|E1|Reported Event|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
203355|NCT01186250|B3|Baseline|Total|Total of all reporting groups
203356|NCT01186250|B2|Baseline|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203357|NCT01186250|B1|Baseline|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203358|NCT01186250|P2|Participant Flow|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203359|NCT01186250|P1|Participant Flow|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203360|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203361|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203362|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203363|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203364|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203365|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203366|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203367|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203368|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203369|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203370|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203371|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203372|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203373|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203374|NCT01186250|E2|Reported Event|Placebo|"Placebo~Placebo: placebo taken daily for one year"
203375|NCT01186250|E1|Reported Event|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
203536|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203378|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
203379|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
203380|NCT01185834|E1|Reported Event|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
203381|NCT01185782|B3|Baseline|Total|Total of all reporting groups
203382|NCT01185782|B2|Baseline|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203383|NCT01185782|B1|Baseline|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203384|NCT01185782|P2|Participant Flow|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203385|NCT01185782|P1|Participant Flow|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203386|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203387|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203388|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203389|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203390|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203391|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203392|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203393|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203394|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203395|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203396|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203397|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203398|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203399|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203400|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203401|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203402|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203403|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203404|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203405|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203406|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203407|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203408|NCT01185782|E2|Reported Event|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203409|NCT01185782|E1|Reported Event|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
203410|NCT01185704|B3|Baseline|Total|Total of all reporting groups
203411|NCT01185704|B2|Baseline|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203412|NCT01185704|B1|Baseline|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203413|NCT01185704|P2|Participant Flow|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203414|NCT01185704|P1|Participant Flow|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203415|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203416|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203417|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203433|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203624|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203418|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203419|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203420|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203421|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203422|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203423|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203424|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203425|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203426|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203427|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203428|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203429|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203430|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203431|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203432|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203492|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
225936|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
203434|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203435|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203436|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203437|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203438|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203439|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203440|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203441|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203442|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203443|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203444|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203445|NCT01185704|E2|Reported Event|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203446|NCT01185704|E1|Reported Event|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
203447|NCT01185600|B3|Baseline|Total|Total of all reporting groups
203448|NCT01185600|B2|Baseline|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203449|NCT01185600|B1|Baseline|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203450|NCT01185600|P2|Participant Flow|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203451|NCT01185600|P1|Participant Flow|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203452|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203453|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203454|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203455|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203456|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203457|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203458|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203459|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203460|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203461|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203462|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203463|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203464|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203465|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency,or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203466|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203467|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203468|NCT01185600|E2|Reported Event|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
203469|NCT01185600|E1|Reported Event|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
203470|NCT01185561|B3|Baseline|Total|Total of all reporting groups
203471|NCT01185561|B2|Baseline|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203472|NCT01185561|B1|Baseline|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203473|NCT01185561|P2|Participant Flow|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203474|NCT01185561|P1|Participant Flow|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203475|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203476|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203477|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203478|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203479|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203480|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203481|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203482|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203483|NCT01185561|E2|Reported Event|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
203484|NCT01185561|E1|Reported Event|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
203485|NCT01185522|B1|Baseline|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203486|NCT01185522|P1|Participant Flow|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203487|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203488|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203489|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203490|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203491|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203497|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203498|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203499|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203500|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203501|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203502|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203503|NCT01185522|O1|Outcome|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203504|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203505|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203506|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203507|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203508|NCT01185522|E1|Reported Event|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
203509|NCT01185301|B5|Baseline|Total|Total of all reporting groups
203510|NCT01185301|B4|Baseline|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203511|NCT01185301|B3|Baseline|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203512|NCT01185301|B2|Baseline|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203513|NCT01185301|B1|Baseline|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203514|NCT01185301|P4|Participant Flow|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203515|NCT01185301|P3|Participant Flow|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203516|NCT01185301|P2|Participant Flow|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203517|NCT01185301|P1|Participant Flow|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203518|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203519|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203520|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203521|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203522|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203523|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203524|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203525|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203526|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203527|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203528|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203529|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203530|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203531|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203532|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203533|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203534|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203537|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203538|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203539|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203540|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203541|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203542|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203543|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203544|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203545|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203546|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203547|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203548|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203549|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203550|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203551|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203552|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203553|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203554|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203555|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203556|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203557|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203558|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203559|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203560|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203561|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203562|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203563|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203564|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203565|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203566|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203567|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203568|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203569|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203570|NCT01185301|E4|Reported Event|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
203571|NCT01185301|E3|Reported Event|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203572|NCT01185301|E2|Reported Event|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
203573|NCT01185301|E1|Reported Event|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
203574|NCT01185288|B3|Baseline|Total|Total of all reporting groups
203575|NCT01185288|B2|Baseline|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
225937|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
203576|NCT01185288|B1|Baseline|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203577|NCT01185288|P2|Participant Flow|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203578|NCT01185288|P1|Participant Flow|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203579|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203580|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203581|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203582|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203583|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203584|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203585|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203586|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203587|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203588|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203589|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203590|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203591|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203592|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203593|NCT01185288|E2|Reported Event|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
203594|NCT01185288|E1|Reported Event|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
203595|NCT01185249|B1|Baseline|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
203596|NCT01185249|P1|Participant Flow|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
203597|NCT01185249|O2|Outcome|Morning Weight|Weight of study patients in kilograms first thing in the morning.
203598|NCT01185249|O1|Outcome|Evening Weights|Patients with both morning and evening weights
203599|NCT01185249|E1|Reported Event|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
203600|NCT01185080|B4|Baseline|Total|Total of all reporting groups
203601|NCT01185080|B3|Baseline|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203602|NCT01185080|B2|Baseline|Placebo|Placebo three times weekly
203603|NCT01185080|B1|Baseline|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203604|NCT01185080|P3|Participant Flow|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203605|NCT01185080|P2|Participant Flow|Placebo|Placebo three times weekly
203606|NCT01185080|P1|Participant Flow|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203607|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203608|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203609|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203610|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203611|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203612|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203613|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203614|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203615|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203616|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203617|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203618|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203619|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203620|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203621|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203622|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203623|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203637|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203638|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203639|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203640|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203641|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203642|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203643|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203644|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203645|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203646|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203647|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
203648|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203649|NCT01185080|E3|Reported Event|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
203650|NCT01185080|E2|Reported Event|Placebo|Placebo three times weekly
203651|NCT01185080|E1|Reported Event|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
203652|NCT01185028|B1|Baseline|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
203653|NCT01185028|P1|Participant Flow|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
203654|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
203655|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
203656|NCT01185028|E1|Reported Event|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
203657|NCT01184989|B1|Baseline|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
203658|NCT01184989|P1|Participant Flow|Patients Treated With Dabigatran Etexilate|"Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.~142 patients were enrolled for the study, but only 112 were treated. Therefore, the number of started patients corresponds to the ones that were actually treated."
203659|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
203660|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
203661|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
203662|NCT01184989|E1|Reported Event|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
203663|NCT01184898|B1|Baseline|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203664|NCT01184898|P1|Participant Flow|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203665|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203666|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203667|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203668|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203669|NCT01184898|E1|Reported Event|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
203716|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
204043|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
203670|NCT01184885|B1|Baseline|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
203671|NCT01184885|P1|Participant Flow|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
203672|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
203673|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
203674|NCT01184885|E1|Reported Event|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
203675|NCT01184872|B3|Baseline|Total|Total of all reporting groups
203676|NCT01184872|B2|Baseline|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203677|NCT01184872|B1|Baseline|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203678|NCT01184872|P2|Participant Flow|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203679|NCT01184872|P1|Participant Flow|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203680|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203681|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203682|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203683|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203717|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203718|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203684|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203685|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203686|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203687|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203688|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203689|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203690|NCT01184872|E2|Reported Event|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
203691|NCT01184872|E1|Reported Event|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
203692|NCT01184859|B6|Baseline|Total|Total of all reporting groups
203693|NCT01184859|B5|Baseline|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203694|NCT01184859|B4|Baseline|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203695|NCT01184859|B3|Baseline|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203696|NCT01184859|B2|Baseline|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203697|NCT01184859|B1|Baseline|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203698|NCT01184859|P5|Participant Flow|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203699|NCT01184859|P4|Participant Flow|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203700|NCT01184859|P3|Participant Flow|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203701|NCT01184859|P2|Participant Flow|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203702|NCT01184859|P1|Participant Flow|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203703|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203704|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203705|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203706|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203707|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203708|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203709|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203710|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203711|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203712|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203713|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203714|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203715|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
204044|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
203719|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203720|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203721|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203722|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203723|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203724|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203725|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203726|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203727|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203728|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203729|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203730|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203731|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203732|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203733|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203734|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203735|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203736|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203737|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203738|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203739|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203740|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203741|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203742|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203743|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203744|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203745|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203746|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203747|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203748|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203749|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203750|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203751|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203752|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203753|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203754|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203755|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203756|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203757|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203758|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203759|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203760|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203761|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203762|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203763|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203764|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203765|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203766|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203767|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203768|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203769|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203770|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203771|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203772|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203773|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203774|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203775|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203776|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203777|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203778|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203779|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203780|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203781|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203782|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
203783|NCT01184859|E10|Reported Event|Desmopressin 100µg - Period 2|Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
203784|NCT01184859|E9|Reported Event|Desmopressin 50µg - Period 2|Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
203785|NCT01184859|E8|Reported Event|Desmopressin 25µg - Period 2|Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
203786|NCT01184859|E7|Reported Event|Desmopressin 10µg - Period 2|Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
203787|NCT01184859|E6|Reported Event|Placebo - Period 2|Study period 2: daily doses of placebo taken before bedtime for 28 days.
203788|NCT01184859|E5|Reported Event|Desmopressin 100µg - Period 1|Study period 1: single dose of desmopressin 100µg.
203789|NCT01184859|E4|Reported Event|Desmopressin 50µg - Period 1|Study period 1: single dose of desmopressin 50µg.
203790|NCT01184859|E3|Reported Event|Desmopressin 25µg - Period 1|Study period 1: single dose of desmopressin 25µg.
203791|NCT01184859|E2|Reported Event|Desmopressin 10µg - Period 1|Study period 1: single dose of desmopressin 10µg.
203792|NCT01184859|E1|Reported Event|Placebo-Period 1|Study period 1: single dose of placebo.
203793|NCT01184846|B1|Baseline|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203794|NCT01184846|P1|Participant Flow|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203795|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
204042|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
203796|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203797|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203798|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203799|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203800|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203801|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203802|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203803|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203804|NCT01184846|O2|Outcome|IgPro10 - After Infusion|IgG levels were determined after infusion with IgPro10.
203805|NCT01184846|O1|Outcome|IgPro10 - Before Infusion|IgG levels were determined before infusion with IgPro10.
203806|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203807|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203808|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203809|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203810|NCT01184846|E1|Reported Event|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
203811|NCT01184417|B3|Baseline|Total|Total of all reporting groups
203812|NCT01184417|B2|Baseline|Placebo Group|100 ml saline
203813|NCT01184417|B1|Baseline|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203814|NCT01184417|P2|Participant Flow|Placebo Group|100 ml saline
203815|NCT01184417|P1|Participant Flow|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203816|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203817|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203818|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203819|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203820|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203821|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203822|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203823|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203824|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203825|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203826|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203827|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203828|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203829|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203830|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
203831|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203832|NCT01184417|E2|Reported Event|Placebo Group|100 ml saline
203833|NCT01184417|E1|Reported Event|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
203834|NCT01184118|B1|Baseline|FP 220 mcg 2 Puffs BID|"The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.~FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care."
203835|NCT01184118|P1|Participant Flow|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
203942|NCT01183481|P1|Participant Flow|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
203836|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
203837|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
203838|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
203839|NCT01184118|E1|Reported Event|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
203840|NCT01184079|B3|Baseline|Total|Total of all reporting groups
203841|NCT01184079|B2|Baseline|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203842|NCT01184079|B1|Baseline|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203843|NCT01184079|P2|Participant Flow|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203844|NCT01184079|P1|Participant Flow|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203845|NCT01184079|O2|Outcome|Group With Administration of 3rd Dose at 6 Months|"Group with administration of 3rd dose at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203846|NCT01184079|O1|Outcome|Group With Administration of 3rd Dose at 12 Months|"Group with administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203847|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203848|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203849|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203850|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203851|NCT01184079|E2|Reported Event|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
203852|NCT01184079|E1|Reported Event|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
203853|NCT01184014|B3|Baseline|Total|Total of all reporting groups
203854|NCT01184014|B2|Baseline|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
203855|NCT01184014|B1|Baseline|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
203856|NCT01184014|P2|Participant Flow|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
203857|NCT01184014|P1|Participant Flow|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
203858|NCT01184014|O2|Outcome|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
203859|NCT01184014|O1|Outcome|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
203860|NCT01184014|E2|Reported Event|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
203861|NCT01184014|E1|Reported Event|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
203862|NCT01183975|B1|Baseline|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
203863|NCT01183975|P1|Participant Flow|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
203864|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
203865|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
203990|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203866|NCT01183975|E1|Reported Event|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
203867|NCT01183858|B3|Baseline|Total|Total of all reporting groups
203868|NCT01183858|B2|Baseline|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203869|NCT01183858|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203870|NCT01183858|P2|Participant Flow|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203871|NCT01183858|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203872|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203873|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203874|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203875|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203876|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203877|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203878|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203879|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203880|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203881|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203882|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203883|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203884|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203885|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203886|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203887|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203888|NCT01183858|E2|Reported Event|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
203889|NCT01183858|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
203890|NCT01183780|B3|Baseline|Total|Total of all reporting groups
203891|NCT01183780|B2|Baseline|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203892|NCT01183780|B1|Baseline|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203893|NCT01183780|P2|Participant Flow|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203894|NCT01183780|P1|Participant Flow|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203895|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203896|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203897|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203991|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203898|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203899|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203900|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203901|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203902|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203903|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203904|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203905|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203906|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203907|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203908|NCT01183780|E2|Reported Event|FOLFIRI + Placebo|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203909|NCT01183780|E1|Reported Event|FOLFIRI + Ramucirumab|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
203910|NCT01183728|B1|Baseline|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
203992|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203993|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203911|NCT01183728|P1|Participant Flow|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
203912|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
203913|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
203914|NCT01183728|E1|Reported Event|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
203915|NCT01183650|B3|Baseline|Total|Total of all reporting groups
203916|NCT01183650|B2|Baseline|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203917|NCT01183650|B1|Baseline|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203918|NCT01183650|P2|Participant Flow|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203919|NCT01183650|P1|Participant Flow|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203920|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203921|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203922|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203923|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203924|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203925|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203926|NCT01183650|E2|Reported Event|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
203927|NCT01183650|E1|Reported Event|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
203928|NCT01183546|B1|Baseline|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
203929|NCT01183546|P1|Participant Flow|Wheelchair Users With Spinal Cord Injury|wheelchair users with spinal cord injury
203930|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
203931|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
203932|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
203933|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
203934|NCT01183546|E1|Reported Event|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
203935|NCT01183533|B1|Baseline|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203936|NCT01183533|P1|Participant Flow|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203937|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203938|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203939|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203940|NCT01183533|E1|Reported Event|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
203941|NCT01183481|B1|Baseline|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
203943|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
203944|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
203945|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
203946|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
203947|NCT01183481|O1|Outcome|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
203948|NCT01183481|E1|Reported Event|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
203949|NCT01183468|B5|Baseline|Total|Total of all reporting groups
203950|NCT01183468|B4|Baseline|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203951|NCT01183468|B3|Baseline|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203952|NCT01183468|B2|Baseline|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203953|NCT01183468|B1|Baseline|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203954|NCT01183468|P4|Participant Flow|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203955|NCT01183468|P3|Participant Flow|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203956|NCT01183468|P2|Participant Flow|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203957|NCT01183468|P1|Participant Flow|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203958|NCT01183468|O4|Outcome|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203959|NCT01183468|O3|Outcome|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
203960|NCT01183468|O2|Outcome|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203961|NCT01183468|O1|Outcome|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203962|NCT01183468|E2|Reported Event|Subjects Aged 8 – 15 Years|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203963|NCT01183468|E1|Reported Event|Subjects Aged 16 – 35 Years|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
203964|NCT01183390|B3|Baseline|Total|Total of all reporting groups
203965|NCT01183390|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
203966|NCT01183390|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
203967|NCT01183390|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
203968|NCT01183390|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
203969|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
203970|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
203971|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
203972|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
203973|NCT01183390|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
203974|NCT01183390|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period
203975|NCT01183312|B3|Baseline|Total|Total of all reporting groups
203976|NCT01183312|B2|Baseline|Flumazenil First, Then Placebo|Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
203977|NCT01183312|B1|Baseline|Placebo First, Then Flumazenil|Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
203978|NCT01183312|P2|Participant Flow|Flumazenil First, Then Placebo|Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.
203979|NCT01183312|P1|Participant Flow|Placebo First, Then Flumazenil|Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
203980|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203981|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203982|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203983|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203984|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203985|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203986|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203987|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203988|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
203989|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
203997|NCT01183234|B2|Baseline|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
203998|NCT01183234|B1|Baseline|Equasym XL First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
203999|NCT01183234|P2|Participant Flow|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
204000|NCT01183234|P1|Participant Flow|Equasym XL (SPD544) First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
204001|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
204002|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
204003|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
204004|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
204005|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
204006|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
204007|NCT01183234|E2|Reported Event|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
204008|NCT01183234|E1|Reported Event|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
204009|NCT01183169|B5|Baseline|Total|Total of all reporting groups
204010|NCT01183169|B4|Baseline|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204011|NCT01183169|B3|Baseline|Treatment C|Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204012|NCT01183169|B2|Baseline|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204013|NCT01183169|B1|Baseline|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204014|NCT01183169|P7|Participant Flow|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204015|NCT01183169|P6|Participant Flow|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204016|NCT01183169|P5|Participant Flow|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204017|NCT01183169|P4|Participant Flow|Treatment C2|Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
204018|NCT01183169|P3|Participant Flow|Treatment C1|Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
204019|NCT01183169|P2|Participant Flow|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204020|NCT01183169|P1|Participant Flow|Treatment A|Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
204021|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204022|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204023|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204024|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204025|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204026|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204027|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204028|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204029|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204030|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204031|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204032|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204033|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204034|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204035|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204036|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204037|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204038|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204039|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204040|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204041|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
225938|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
204045|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204046|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204047|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204048|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204049|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204050|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204051|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204052|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204053|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204054|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204055|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204056|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204057|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204058|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204059|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204060|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204061|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204062|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204063|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204064|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204065|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204066|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204067|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204068|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204069|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204070|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204071|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204072|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204073|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204074|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204075|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
204076|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
204077|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204078|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
204079|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204080|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204081|NCT01183169|E10|Reported Event|Treatment D: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204082|NCT01183169|E9|Reported Event|Treatment C2: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
204083|NCT01183169|E8|Reported Event|Treatment C1: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
204084|NCT01183169|E7|Reported Event|Treatment B: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204085|NCT01183169|E6|Reported Event|Treatment A: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204086|NCT01183169|E5|Reported Event|Treatment D: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
204087|NCT01183169|E4|Reported Event|Treatment C2: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
204088|NCT01183169|E3|Reported Event|Treatment C1: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
204089|NCT01183169|E2|Reported Event|Treatment B: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
204090|NCT01183169|E1|Reported Event|Treatment A: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
204115|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204116|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204117|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204091|NCT01183065|B1|Baseline|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
204092|NCT01183065|P1|Participant Flow|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
204093|NCT01183065|O1|Outcome|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
204094|NCT01183065|E1|Reported Event|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
204095|NCT01183013|B8|Baseline|Total|Total of all reporting groups
204096|NCT01183013|B7|Baseline|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
204097|NCT01183013|B6|Baseline|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204098|NCT01183013|B5|Baseline|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
204099|NCT01183013|B4|Baseline|Lina5/Lina5|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204100|NCT01183013|B3|Baseline|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
204101|NCT01183013|B2|Baseline|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204102|NCT01183013|B1|Baseline|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204103|NCT01183013|P7|Participant Flow|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
204104|NCT01183013|P6|Participant Flow|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204105|NCT01183013|P5|Participant Flow|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204106|NCT01183013|P4|Participant Flow|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
204107|NCT01183013|P3|Participant Flow|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
204108|NCT01183013|P2|Participant Flow|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204109|NCT01183013|P1|Participant Flow|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204110|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204111|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204112|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204113|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204114|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204118|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204119|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204120|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204121|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204122|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204123|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204124|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204125|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204126|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204127|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204128|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204129|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204130|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204131|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204132|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204133|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204134|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204135|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204136|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204137|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204138|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204139|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204140|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204141|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204142|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204143|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204144|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204145|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204146|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204147|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204148|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204149|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204150|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204151|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204152|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204153|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204154|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204155|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204156|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204157|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204158|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204159|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204160|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204161|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204162|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
225939|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
204163|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
204164|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204165|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204166|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204167|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204168|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204169|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204170|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
204171|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204172|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204173|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
204174|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
204175|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
204176|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
204177|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
204178|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
204179|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
204180|NCT01183013|E7|Reported Event|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
204181|NCT01183013|E6|Reported Event|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204182|NCT01183013|E5|Reported Event|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
204183|NCT01183013|E4|Reported Event|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
204184|NCT01183013|E3|Reported Event|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
204185|NCT01183013|E2|Reported Event|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204186|NCT01183013|E1|Reported Event|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
204187|NCT01182805|B1|Baseline|Single Arm Study.|
204188|NCT01182805|P1|Participant Flow|All Study Participants|All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
204189|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
204190|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
204191|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
204192|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
204193|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
204194|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
204195|NCT01182805|E1|Reported Event|Single Arm Study.|
204196|NCT01182727|B1|Baseline|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
204197|NCT01182727|P1|Participant Flow|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
204216|NCT01182610|E1|Reported Event|Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU|Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
204217|NCT01182493|B3|Baseline|Total|Total of all reporting groups
204198|NCT01182727|O1|Outcome|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
204199|NCT01182727|E1|Reported Event|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
204200|NCT01182675|B3|Baseline|Total|Total of all reporting groups
204201|NCT01182675|B2|Baseline|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
204202|NCT01182675|B1|Baseline|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
204203|NCT01182675|P2|Participant Flow|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
204204|NCT01182675|P1|Participant Flow|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
204205|NCT01182675|O2|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
204206|NCT01182675|O1|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
204207|NCT01182675|E2|Reported Event|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
204208|NCT01182675|E1|Reported Event|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
204209|NCT01182610|B1|Baseline|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36~Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204210|NCT01182610|P1|Participant Flow|Treatment Group|"Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204211|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204212|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204213|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204214|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204215|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
204365|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204218|NCT01182493|B2|Baseline|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
204219|NCT01182493|B1|Baseline|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient"
204220|NCT01182493|P2|Participant Flow|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
204221|NCT01182493|P1|Participant Flow|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
204222|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
204223|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
204224|NCT01182493|E2|Reported Event|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
204225|NCT01182493|E1|Reported Event|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
204226|NCT01182480|B1|Baseline|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
204227|NCT01182480|P1|Participant Flow|Text Intervention|Group of study participants who received the text message intervention over a 3-month period. Participants received text messages 7, 2, and 1 day(s) prior to each of their scheduled appointments as recorded in the Denver Health scheduling system, and also received text messages prompts 3 times per week asking them to provide fasting blood sugar readings.
204228|NCT01182480|O1|Outcome|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
204229|NCT01182480|E1|Reported Event|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
204230|NCT01182428|B3|Baseline|Total|Total of all reporting groups
204231|NCT01182428|B2|Baseline|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204232|NCT01182428|B1|Baseline|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204233|NCT01182428|P2|Participant Flow|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204234|NCT01182428|P1|Participant Flow|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204235|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204236|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204237|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204238|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204239|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204240|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204241|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204242|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204243|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204244|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204245|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204246|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204247|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204248|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204249|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204250|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204251|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204536|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204252|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204253|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204254|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204255|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204256|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204257|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204258|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204259|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204260|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204261|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204262|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204263|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204264|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204265|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204266|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204267|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204268|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204269|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204270|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204271|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204272|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204273|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204274|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204275|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204276|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204277|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204278|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204279|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204280|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204281|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204282|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204283|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204284|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204285|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204286|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204287|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204288|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204289|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204290|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204291|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204292|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204293|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204294|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204295|NCT01182428|E2|Reported Event|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204296|NCT01182428|E1|Reported Event|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
204297|NCT01182376|B3|Baseline|Total|Total of all reporting groups
204298|NCT01182376|B2|Baseline|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204299|NCT01182376|B1|Baseline|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204300|NCT01182376|P2|Participant Flow|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204301|NCT01182376|P1|Participant Flow|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204302|NCT01182376|O2|Outcome|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204303|NCT01182376|O1|Outcome|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204304|NCT01182376|E2|Reported Event|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204305|NCT01182376|E1|Reported Event|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
204306|NCT01182337|B3|Baseline|Total|Total of all reporting groups
204307|NCT01182337|B2|Baseline|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204308|NCT01182337|B1|Baseline|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204309|NCT01182337|P2|Participant Flow|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204310|NCT01182337|P1|Participant Flow|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204311|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204312|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204313|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204314|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204315|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204366|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204316|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204317|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204318|NCT01182337|O1|Outcome|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204319|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204320|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204321|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204322|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204323|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204324|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204325|NCT01182337|E2|Reported Event|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
204326|NCT01182337|E1|Reported Event|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
204327|NCT01182298|B1|Baseline|Standard|HCV INFECTED LATINO ARTICIPANTS
204328|NCT01182298|P1|Participant Flow|PegIFN and Ribavirin|"Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.~This is an observational study. The observed treatment is received and managed through their primary care."
204329|NCT01182298|O1|Outcome|Hepatitis C|latino participants with Hepatitis C
204330|NCT01182298|E1|Reported Event|Standard|Patients receiving weekly peg interferon and ribavirin for hCV treatment were studied This is an observational study. The observed treatment is received and managed through their primary care.
204331|NCT01182285|B1|Baseline|All Participants (Phase 1 and Phase 2 Schedule 2)|"A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening~B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks."
204332|NCT01182285|P3|Participant Flow|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
204333|NCT01182285|P2|Participant Flow|B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
204334|NCT01182285|P1|Participant Flow|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
204335|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
204367|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204368|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204369|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204336|NCT01182285|O1|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radiiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
204337|NCT01182285|O1|Outcome|All Participants|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
204338|NCT01182285|O2|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
204339|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
204340|NCT01182285|E1|Reported Event|All Participants (Phase 1 and Phase 2 Schedule 2)|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
204341|NCT01182207|B3|Baseline|Total|Total of all reporting groups
204342|NCT01182207|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
204343|NCT01182207|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
204344|NCT01182207|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
204345|NCT01182207|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
204346|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204347|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204348|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204349|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204350|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204351|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204352|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204353|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204354|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204355|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204356|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204357|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204358|NCT01182207|E2|Reported Event|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204359|NCT01182207|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204360|NCT01182194|B3|Baseline|Total|Total of all reporting groups
204361|NCT01182194|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
204362|NCT01182194|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
204363|NCT01182194|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
204364|NCT01182194|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
204370|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204371|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204372|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204373|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204374|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204375|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
204376|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
204377|NCT01182194|E2|Reported Event|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
204378|NCT01182194|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
204379|NCT01182181|B3|Baseline|Total|Total of all reporting groups
204380|NCT01182181|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
204381|NCT01182181|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
204382|NCT01182181|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
204383|NCT01182181|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
204384|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
204385|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
204386|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
204387|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
204388|NCT01182181|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
204389|NCT01182181|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
204390|NCT01182103|B3|Baseline|Total|Total of all reporting groups
204391|NCT01182103|B2|Baseline|Healthy Subjects|
204392|NCT01182103|B1|Baseline|Major Depressive Patients|
204393|NCT01182103|P2|Participant Flow|Healthy Subjects|
204394|NCT01182103|P1|Participant Flow|Major Depressive Patients|
204395|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
204396|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
204397|NCT01182103|O1|Outcome|Healthy Subjects|
204398|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
204399|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
204400|NCT01182103|O1|Outcome|Healthy Subjects|
204401|NCT01182103|O2|Outcome|Healthy Subjects|
204402|NCT01182103|O1|Outcome|Major Depressive Patients|
204403|NCT01182103|E2|Reported Event|Healthy Subjects|
204404|NCT01182103|E1|Reported Event|Major Depressive Patients|
204405|NCT01181986|B3|Baseline|Total|Total of all reporting groups
204406|NCT01181986|B2|Baseline|Sub-study 2: Exenatide IV|Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
204407|NCT01181986|B1|Baseline|Sub-study 1: Exenatide SC|Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
204408|NCT01181986|P3|Participant Flow|Exenatide IV (Sub-study 2)|Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
204409|NCT01181986|P2|Participant Flow|Placebo Then Exenatide (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204410|NCT01181986|P1|Participant Flow|Exenatide Then Placebo (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204411|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204412|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204413|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204414|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
204415|NCT01181986|O5|Outcome|Exendin-9+Exenatide (Sub-study 2)|Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
204416|NCT01181986|O4|Outcome|Saline+Placebo (Sub-study 2)|Infusion of saline (min 0-75), added placebo infusion (min 30-75)
204417|NCT01181986|O3|Outcome|Saline+Exenatide (Sub-study 2)|Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
204418|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Placebo sc BID for 10 days
204419|NCT01181986|O1|Outcome|Exenatide (Subs-study 1)|Exenatide: Exenatide 5-10 ug sc BID/10 days
204420|NCT01181986|E5|Reported Event|Exendin-9+Exenatide IV (Sub-study 2)|Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
204421|NCT01181986|E4|Reported Event|Saline+Placebo (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
204422|NCT01181986|E3|Reported Event|Saline+Exenatide IV (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
204423|NCT01181986|E2|Reported Event|Placebo SC (Sub-study 1)|Placebo sc BID/10days, AM dose and meal test on day 11
204424|NCT01181986|E1|Reported Event|Exenatide SC (Sub-study 1)|Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
204425|NCT01181947|B1|Baseline|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
204426|NCT01181947|P1|Participant Flow|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
204427|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
204428|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection~TEVAR: Thoracic endovascular aneurysm repair"
204429|NCT01181947|E1|Reported Event|1. VCOUS|Medtronic VCOUS
204430|NCT01181921|B1|Baseline|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
204431|NCT01181921|P1|Participant Flow|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
204432|NCT01181921|O1|Outcome|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
204433|NCT01181921|E1|Reported Event|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
204434|NCT01181895|B4|Baseline|Total|Total of all reporting groups
204435|NCT01181895|B3|Baseline|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204436|NCT01181895|B2|Baseline|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204437|NCT01181895|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204438|NCT01181895|P3|Participant Flow|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204439|NCT01181895|P2|Participant Flow|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204440|NCT01181895|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204441|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204442|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204443|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204444|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204445|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204446|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204564|NCT01181531|B2|Baseline|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
204447|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204448|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204449|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204450|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204451|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204452|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204453|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204454|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204455|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204456|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204457|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204458|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204459|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204460|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204461|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204462|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204463|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204464|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204465|NCT01181895|E3|Reported Event|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204535|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204466|NCT01181895|E2|Reported Event|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
204467|NCT01181895|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
204468|NCT01181804|B5|Baseline|Total|Total of all reporting groups
204469|NCT01181804|B4|Baseline|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
204470|NCT01181804|B3|Baseline|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
204471|NCT01181804|B2|Baseline|Boceprevir Capsules Then Tablets (Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
204472|NCT01181804|B1|Baseline|Boceprevir Tablets Then Capsules (Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
204473|NCT01181804|P4|Participant Flow|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
204474|NCT01181804|P3|Participant Flow|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
204475|NCT01181804|P2|Participant Flow|Boceprevir Capsules Then Tablets ( Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
204476|NCT01181804|P1|Participant Flow|Boceprevir Tablets Then Capsules ( Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
204477|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204478|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204479|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204480|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204481|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204482|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204483|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204484|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204485|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204486|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204487|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204488|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204489|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204490|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204491|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204492|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204493|NCT01181804|E4|Reported Event|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204494|NCT01181804|E3|Reported Event|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
204495|NCT01181804|E2|Reported Event|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204496|NCT01181804|E1|Reported Event|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
204497|NCT01181778|B1|Baseline|All Participants|All participants who were enrolled in the study
204498|NCT01181778|P1|Participant Flow|All Participants|All participants who were enrolled in the study
204499|NCT01181778|O1|Outcome|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
204500|NCT01181778|O2|Outcome|All Qualified Participants After Counseling|After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
204501|NCT01181778|O1|Outcome|All Qualified Participants Before Counseling|Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
204502|NCT01181778|E1|Reported Event|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
204503|NCT01181726|B3|Baseline|Total|Total of all reporting groups
204504|NCT01181726|B2|Baseline|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
204505|NCT01181726|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
204506|NCT01181726|P2|Participant Flow|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
204507|NCT01181726|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
204508|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204509|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204510|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204511|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204512|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204513|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204514|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204515|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204516|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204517|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204518|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204519|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204520|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204521|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204522|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204523|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204524|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204525|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204526|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204527|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204528|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204529|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204530|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204531|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204532|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204533|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204534|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
225940|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
204537|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204538|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204539|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204540|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204541|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204542|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204543|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204544|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204545|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204546|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204547|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204548|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204549|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204550|NCT01181726|E2|Reported Event|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
204551|NCT01181726|E1|Reported Event|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
204552|NCT01181609|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204553|NCT01181609|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204554|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204555|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204556|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204557|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204558|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204559|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204560|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204561|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204562|NCT01181609|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
204563|NCT01181531|B3|Baseline|Total|Total of all reporting groups
204565|NCT01181531|B1|Baseline|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204566|NCT01181531|P2|Participant Flow|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
204567|NCT01181531|P1|Participant Flow|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204568|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
204569|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204570|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
204571|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204572|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
204573|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204574|NCT01181531|E2|Reported Event|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
204575|NCT01181531|E1|Reported Event|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
204576|NCT01181492|B4|Baseline|Total|Total of all reporting groups
204577|NCT01181492|B3|Baseline|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204578|NCT01181492|B2|Baseline|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204579|NCT01181492|B1|Baseline|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204580|NCT01181492|P3|Participant Flow|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204581|NCT01181492|P2|Participant Flow|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204582|NCT01181492|P1|Participant Flow|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204583|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204584|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204585|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204586|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204587|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204588|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204589|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204590|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204591|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204592|NCT01181492|E3|Reported Event|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
204593|NCT01181492|E2|Reported Event|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
204594|NCT01181492|E1|Reported Event|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
204595|NCT01181349|B1|Baseline|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
204596|NCT01181349|P1|Participant Flow|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
204597|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
204598|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
204599|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
204600|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
204601|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
204602|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
204603|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
204604|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
204605|NCT01181349|O1|Outcome|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
204606|NCT01181349|E1|Reported Event|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
204607|NCT01181323|B5|Baseline|Total|Total of all reporting groups
204608|NCT01181323|B4|Baseline|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204609|NCT01181323|B3|Baseline|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204610|NCT01181323|B2|Baseline|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204611|NCT01181323|B1|Baseline|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204612|NCT01181323|P4|Participant Flow|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204613|NCT01181323|P3|Participant Flow|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204672|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204614|NCT01181323|P2|Participant Flow|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204615|NCT01181323|P1|Participant Flow|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
204616|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204617|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204618|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204619|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204620|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204621|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204622|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204623|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204624|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204625|NCT01181323|O3|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204626|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204627|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204628|NCT01181323|O1|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204629|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204630|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204631|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204632|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204633|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204634|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204635|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204636|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204637|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204638|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204639|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
204640|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
204641|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204642|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204643|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204914|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204644|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204645|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204646|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204647|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204648|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204649|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204650|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204651|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204652|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204653|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204654|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204655|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204656|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204657|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204658|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204659|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204660|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204661|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204662|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204663|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204664|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204665|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204666|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204667|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
204668|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
204669|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
204670|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
204671|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204673|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204674|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204675|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204676|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204677|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204678|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204679|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204680|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204681|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204682|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204683|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204684|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204685|NCT01181323|E4|Reported Event|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
204686|NCT01181323|E3|Reported Event|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
204687|NCT01181323|E2|Reported Event|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
204688|NCT01181323|E1|Reported Event|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
204689|NCT01181167|B3|Baseline|Total|Total of all reporting groups
204690|NCT01181167|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204691|NCT01181167|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204692|NCT01181167|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204693|NCT01181167|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204694|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204695|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204696|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204697|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204698|NCT01181167|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204699|NCT01181167|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204700|NCT01181141|B3|Baseline|Total|Total of all reporting groups
204701|NCT01181141|B2|Baseline|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
204702|NCT01181141|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
204703|NCT01181141|P2|Participant Flow|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
204704|NCT01181141|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
204705|NCT01181141|O2|Outcome|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
204706|NCT01181141|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
204707|NCT01181141|E2|Reported Event|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
204708|NCT01181141|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
204709|NCT01181128|B4|Baseline|Total|Total of all reporting groups
204710|NCT01181128|B3|Baseline|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204711|NCT01181128|B2|Baseline|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204746|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204747|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204915|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
204712|NCT01181128|B1|Baseline|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204713|NCT01181128|P3|Participant Flow|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204714|NCT01181128|P2|Participant Flow|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204715|NCT01181128|P1|Participant Flow|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204716|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204717|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204718|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204719|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204720|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204721|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204722|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204723|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204724|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204725|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204726|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204727|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204728|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204729|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204730|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204731|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204732|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204733|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204734|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204735|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204736|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204764|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204765|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204737|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204738|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204739|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204740|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204741|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204742|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204743|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204744|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204745|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204748|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204749|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204750|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204751|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204752|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204753|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204754|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204755|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204756|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204757|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204758|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204759|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204760|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204761|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204762|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204763|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204766|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204767|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204768|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204769|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204770|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204771|NCT01181128|O1|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204772|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204773|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204774|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204775|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204832|NCT01181011|O2|Outcome|Amlodipine 5mg|
204833|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204834|NCT01181011|O2|Outcome|Amlodipine 5mg|
204835|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204836|NCT01181011|O2|Outcome|Amlodipine 5mg|
204837|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204838|NCT01181011|O2|Outcome|Amlodipine 5mg|
204839|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204840|NCT01181011|O2|Outcome|Amlodipine 5mg|
204841|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204776|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204777|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204778|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204779|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204780|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204781|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204782|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204783|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204784|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204785|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204786|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204787|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204788|NCT01181128|O5|Outcome|Any Arm: Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
204789|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204790|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204791|NCT01181128|O2|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, rFVIIIFc Only|"On rFVIIIFc Day 0, participants underwent pharmacokinetic (PK) analysis with a single dose of 50 IU/kg rFVIIIFc in order to estimate their PK parameters and guide the appropriate dose or interval of dosing.~After the PK assessment, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by PK analyses, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204842|NCT01181011|O2|Outcome|Amlodipine 5mg|
204843|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204844|NCT01181011|O2|Outcome|Telmisartan 80mg|
204792|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, Advate|"Participants underwent pharmacokinetic (PK) analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) and then a single dose of 50 IU/kg rFVIIIFc (rFVIIIFc Day 0) within 8 weeks of the Advate dose. A >= 96 hour washout from Advate or any other FVIII product was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via IV injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204793|NCT01181128|O4|Outcome|All Arms: Total|All participants from the Individualized (Tailored) Prophylaxis, Weekly Prophylaxis, and Episodic (On-Demand) Dosing arms.
204794|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
204795|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204796|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
204797|NCT01181128|E3|Reported Event|Episodic (On-Demand) Dosing|Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
204798|NCT01181128|E2|Reported Event|Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
204799|NCT01181128|E1|Reported Event|Individualized (Tailored) Prophylaxis, rFVIIIFc|"Initial twice weekly dosing with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days to maintain a trough level of 1% to 3% (or higher, as clinically indicated) rFVIIIFc activity.~Prior to rFVIIIFc treatment, on rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with rFVIIIFc in order to estimate participant's PK parameters and guide the appropriate dose or interval of dosing. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~A subset of participants (Sequential PK Subgroup) also had PK profiling performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout from Advate or any other FVIII product was performed before the first PK dose of rFVIIIFc was administered."
204800|NCT01181102|B3|Baseline|Total|Total of all reporting groups
204801|NCT01181102|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204802|NCT01181102|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204803|NCT01181102|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204804|NCT01181102|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204805|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204806|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204807|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204808|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204809|NCT01181102|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
204810|NCT01181102|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
204811|NCT01181050|B3|Baseline|Total|Total of all reporting groups
204812|NCT01181050|B2|Baseline|Placebo|Subjects received a single dose of placebo
204813|NCT01181050|B1|Baseline|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204814|NCT01181050|P2|Participant Flow|Placebo|Subjects received a single dose of placebo
204815|NCT01181050|P1|Participant Flow|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204816|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
204817|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204818|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
204819|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204820|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
204821|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204822|NCT01181050|E2|Reported Event|Placebo|Subjects received a single dose of placebo
204823|NCT01181050|E1|Reported Event|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
204824|NCT01181011|B1|Baseline|All Participants|all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
204825|NCT01181011|P1|Participant Flow|All Participants|
204826|NCT01181011|O3|Outcome|Amlodipine 5mg|
204827|NCT01181011|O2|Outcome|Telmisartan 80mg|
204828|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204829|NCT01181011|O3|Outcome|Amlodipine 5mg|
204830|NCT01181011|O2|Outcome|Telmisartan 80mg|
204831|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
204872|NCT01180998|B3|Baseline|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
204873|NCT01180998|B2|Baseline|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
204874|NCT01180998|B1|Baseline|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
204875|NCT01180998|P3|Participant Flow|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
204876|NCT01180998|P2|Participant Flow|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
204877|NCT01180998|P1|Participant Flow|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
204878|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
204879|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
204880|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
204881|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
204882|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
204883|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
204884|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
204885|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
204886|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
204887|NCT01180998|E3|Reported Event|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
204888|NCT01180998|E2|Reported Event|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.
204889|NCT01180998|E1|Reported Event|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.
204890|NCT01180985|B1|Baseline|All Subjects|All enrolled subjects at baseline.
204891|NCT01180985|P2|Participant Flow|Comfilcon A (Control)/Galyfilcon A (Test)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
204892|NCT01180985|P1|Participant Flow|Galyfilcon A (Test)/Comfilcon A (Control)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
204893|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All subjects who wore galyfilcon A lenses
204894|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All subjects who wore comfilcon A lenses
204895|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204896|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204897|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204898|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204899|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204900|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204901|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204902|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204903|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204904|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204905|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
204906|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
204907|NCT01180985|E1|Reported Event|Galyfilcon A Prototype/Comfilcon A|All enrolled subjects were to wear both lenses through the course of the study.
204908|NCT01180894|B3|Baseline|Total|Total of all reporting groups
204909|NCT01180894|B2|Baseline|Placebo|"Placebo~100 mg Normal saline"
204910|NCT01180894|B1|Baseline|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204911|NCT01180894|P2|Participant Flow|Placebo|Placebo (100 mg normal saline)
204912|NCT01180894|P1|Participant Flow|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204913|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
205007|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
204916|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204917|NCT01180894|O2|Outcome|Placebo|"Placebo~100 mg Normal saline"
204918|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204919|NCT01180894|O2|Outcome|Placebo|"Pacebo - Normal Saline~Placebo"
204920|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204921|NCT01180894|E2|Reported Event|Placebo|"Placebo~100 mg Normal saline"
204922|NCT01180894|E1|Reported Event|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
204923|NCT01180790|B8|Baseline|Total|Total of all reporting groups
204924|NCT01180790|B7|Baseline|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204925|NCT01180790|B6|Baseline|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204926|NCT01180790|B5|Baseline|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204927|NCT01180790|B4|Baseline|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204928|NCT01180790|B3|Baseline|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204929|NCT01180790|B2|Baseline|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204930|NCT01180790|B1|Baseline|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204931|NCT01180790|P7|Participant Flow|Segment 2 - 800 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
204932|NCT01180790|P6|Participant Flow|Segment 2 - 400 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
204933|NCT01180790|P5|Participant Flow|Segment 2: 200 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
204934|NCT01180790|P4|Participant Flow|Segment 1: Placebo for 28 Days|"Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204935|NCT01180790|P3|Participant Flow|Segment 1: 800 mg ACH-0141625 for 28 Days|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204936|NCT01180790|P2|Participant Flow|Segment 1: 400 mg ACH-0141625 for 28 Days|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204937|NCT01180790|P1|Participant Flow|Segment 1: 200 mg ACH-0141625 for 28 Days|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204938|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204939|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204940|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204941|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
205008|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
204942|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204943|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204944|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204945|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204946|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204947|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204948|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204949|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204950|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204951|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204952|NCT01180790|O7|Outcome|Segment 2 : 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204953|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204954|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204955|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204956|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204957|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204958|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204959|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204960|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204961|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily for~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204962|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204963|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204964|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204965|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204966|NCT01180790|O7|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204967|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204968|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204969|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204970|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204971|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204972|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204973|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204974|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204975|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
204976|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204977|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204978|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204979|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204980|NCT01180790|O3|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204981|NCT01180790|O2|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204982|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204983|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204984|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204985|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204986|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204987|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204988|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204989|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204990|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204991|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204992|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204993|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204994|NCT01180790|E7|Reported Event|Segment 1 - Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204995|NCT01180790|E6|Reported Event|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204996|NCT01180790|E5|Reported Event|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204997|NCT01180790|E4|Reported Event|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204998|NCT01180790|E3|Reported Event|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
204999|NCT01180790|E2|Reported Event|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
205000|NCT01180790|E1|Reported Event|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
205001|NCT01180777|B1|Baseline|All Subjects|Subjects were to wear all three lenses over the course of the study.
205002|NCT01180777|P1|Participant Flow|All Subjects|All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
205003|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
205004|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
205005|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
205006|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
205012|NCT01180777|E1|Reported Event|All Subjects|Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
205013|NCT01180660|B3|Baseline|Total|Total of all reporting groups
205014|NCT01180660|B2|Baseline|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
205015|NCT01180660|B1|Baseline|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
205016|NCT01180660|P2|Participant Flow|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
205017|NCT01180660|P1|Participant Flow|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
205018|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
205019|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
205020|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
205021|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
205022|NCT01180660|E2|Reported Event|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
205023|NCT01180660|E1|Reported Event|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
205024|NCT01180647|B3|Baseline|Total|Total of all reporting groups
205025|NCT01180647|B2|Baseline|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205026|NCT01180647|B1|Baseline|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205027|NCT01180647|P2|Participant Flow|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205028|NCT01180647|P1|Participant Flow|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205029|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205030|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205031|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205032|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205033|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205034|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205035|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205070|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205071|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205036|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205037|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205038|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205039|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205040|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205041|NCT01180647|E2|Reported Event|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
205042|NCT01180647|E1|Reported Event|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
205043|NCT01180400|B3|Baseline|Total|Total of all reporting groups
205044|NCT01180400|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205045|NCT01180400|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205046|NCT01180400|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205047|NCT01180400|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205048|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205049|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205050|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205051|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205052|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205053|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205054|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205055|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205056|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205057|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205058|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205059|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205060|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205061|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205062|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205063|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205064|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205065|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205066|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205067|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205068|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205069|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205072|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205073|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205074|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205075|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205076|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205077|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205078|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205079|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205080|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205081|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205082|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205083|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205084|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205085|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205086|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205087|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205088|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205089|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205090|NCT01180400|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
205091|NCT01180400|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
205092|NCT01180296|B3|Baseline|Total|Total of all reporting groups
205093|NCT01180296|B2|Baseline|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
205094|NCT01180296|B1|Baseline|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
205095|NCT01180296|P2|Participant Flow|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
205096|NCT01180296|P1|Participant Flow|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
205097|NCT01180296|O2|Outcome|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
205098|NCT01180296|O1|Outcome|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
205099|NCT01180296|E2|Reported Event|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
205100|NCT01180296|E1|Reported Event|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
205101|NCT01180244|B3|Baseline|Total|Total of all reporting groups
205102|NCT01180244|B2|Baseline|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205103|NCT01180244|B1|Baseline|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205104|NCT01180244|P2|Participant Flow|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205105|NCT01180244|P1|Participant Flow|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205106|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205107|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205108|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205109|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205110|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205111|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205112|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205113|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205114|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205115|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205116|NCT01180244|E2|Reported Event|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
205117|NCT01180244|E1|Reported Event|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
205118|NCT01180127|B5|Baseline|Total|Total of all reporting groups
205119|NCT01180127|B4|Baseline|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205120|NCT01180127|B3|Baseline|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205121|NCT01180127|B2|Baseline|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205122|NCT01180127|B1|Baseline|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205123|NCT01180127|P4|Participant Flow|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205124|NCT01180127|P3|Participant Flow|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205125|NCT01180127|P2|Participant Flow|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205126|NCT01180127|P1|Participant Flow|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205127|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205128|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205129|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205130|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205131|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205132|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205133|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205134|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205135|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavonol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205136|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavonol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol"
205137|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavonol containing food product for 12 weeks~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205138|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavonol containing food product~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205139|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205140|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205141|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205142|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205143|NCT01180127|E4|Reported Event|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205144|NCT01180127|E3|Reported Event|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
205145|NCT01180127|E2|Reported Event|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
205146|NCT01180127|E1|Reported Event|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
205147|NCT01179919|B1|Baseline|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
205148|NCT01179919|P1|Participant Flow|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
205149|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
225941|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
205150|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
205151|NCT01179919|E1|Reported Event|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
205152|NCT01179737|B5|Baseline|Total|Total of all reporting groups
205153|NCT01179737|B4|Baseline|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
205154|NCT01179737|B3|Baseline|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
205155|NCT01179737|B2|Baseline|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
205156|NCT01179737|B1|Baseline|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
205157|NCT01179737|P4|Participant Flow|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
205158|NCT01179737|P3|Participant Flow|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
205159|NCT01179737|P2|Participant Flow|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
205160|NCT01179737|P1|Participant Flow|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
205161|NCT01179737|O1|Outcome|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
205162|NCT01179737|O1|Outcome|Change in Pulmonary Vascular Resistance (PVR)|"Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).~Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.~Examples:~Title: all cause mortality Time Frame: one year Safety Issue: No~Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes"
205163|NCT01179737|O1|Outcome|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
205164|NCT01179737|E4|Reported Event|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
205165|NCT01179737|E3|Reported Event|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
205166|NCT01179737|E2|Reported Event|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
205167|NCT01179737|E1|Reported Event|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
205168|NCT01179672|B3|Baseline|Total|Total of all reporting groups
205169|NCT01179672|B2|Baseline|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205170|NCT01179672|B1|Baseline|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205171|NCT01179672|P2|Participant Flow|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205172|NCT01179672|P1|Participant Flow|Duloxetine|30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
205173|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205174|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205175|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205176|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205177|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205178|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205179|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205180|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205181|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205226|NCT01179516|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205182|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
205183|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205184|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205185|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205186|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205187|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205188|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205189|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205190|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205191|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
205192|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
205193|NCT01179672|E4|Reported Event|Placebo Taper|After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
205194|NCT01179672|E3|Reported Event|Duloxetine Taper|After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
205195|NCT01179672|E2|Reported Event|Placebo Treatment|Placebo administered orally, QD for 12 weeks of the treatment.
205196|NCT01179672|E1|Reported Event|Duloxetine Treatment|30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
205197|NCT01179568|B5|Baseline|Total|Total of all reporting groups
205198|NCT01179568|B4|Baseline|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205199|NCT01179568|B3|Baseline|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205200|NCT01179568|B2|Baseline|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205201|NCT01179568|B1|Baseline|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205202|NCT01179568|P4|Participant Flow|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205203|NCT01179568|P3|Participant Flow|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205204|NCT01179568|P2|Participant Flow|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205205|NCT01179568|P1|Participant Flow|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205223|NCT01179568|E1|Reported Event|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205224|NCT01179516|B4|Baseline|Total|Total of all reporting groups
205206|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205207|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205208|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205209|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205210|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205211|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205212|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205213|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205214|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205215|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205216|NCT01179568|O4|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205217|NCT01179568|O3|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205218|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205219|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205220|NCT01179568|E4|Reported Event|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
205221|NCT01179568|E3|Reported Event|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
205222|NCT01179568|E2|Reported Event|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
205225|NCT01179516|B3|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205227|NCT01179516|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205228|NCT01179516|P3|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205229|NCT01179516|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205230|NCT01179516|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205231|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205232|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205233|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205234|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205235|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205236|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205237|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205238|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205239|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205240|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205241|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205242|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205243|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205244|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205245|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205246|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205247|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205248|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205249|NCT01179516|E3|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
205250|NCT01179516|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
205251|NCT01179516|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
205252|NCT01179490|B1|Baseline|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205253|NCT01179490|P1|Participant Flow|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205254|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205255|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205256|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205305|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205360|NCT01179113|E1|Reported Event|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205361|NCT01178853|B3|Baseline|Total|Total of all reporting groups
205257|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205258|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205259|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205260|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205261|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205262|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205263|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205264|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205265|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205266|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205267|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205268|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205269|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205356|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205362|NCT01178853|B2|Baseline|Rosuvastatin/Pitavastatin|
205270|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205271|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205272|NCT01179490|E1|Reported Event|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
205273|NCT01179399|B1|Baseline|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
205274|NCT01179399|P1|Participant Flow|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
205275|NCT01179399|O1|Outcome|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
205276|NCT01179399|E1|Reported Event|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
205277|NCT01179347|B3|Baseline|Total|Total of all reporting groups
205278|NCT01179347|B2|Baseline|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205279|NCT01179347|B1|Baseline|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205280|NCT01179347|P2|Participant Flow|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205281|NCT01179347|P1|Participant Flow|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205282|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205283|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205284|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205285|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205286|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205287|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205288|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205289|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205290|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205291|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205292|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205293|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205294|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205295|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
205296|NCT01179347|E4|Reported Event|Tio 5mcg Randomized Group Over the Study|
205297|NCT01179347|E3|Reported Event|Placebo Randomized Group Over the Open−Label Period|
205298|NCT01179347|E2|Reported Event|Tio 5mcg Randomized Group Over the Double−Blind Period|
205299|NCT01179347|E1|Reported Event|Placebo Randomized Group Over the Double−Blind Period|
205300|NCT01179334|B3|Baseline|Total|Total of all reporting groups
205301|NCT01179334|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205302|NCT01179334|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205303|NCT01179334|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205304|NCT01179334|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205357|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205306|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205307|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205308|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205309|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205310|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205311|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205312|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205313|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205314|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205315|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205316|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205317|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205318|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205319|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205320|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205321|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205322|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205323|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205324|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205325|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205326|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205327|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205358|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205359|NCT01179113|E2|Reported Event|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205363|NCT01178853|B1|Baseline|Pitavastatin/Rosuvastatin|
205328|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205329|NCT01179334|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205330|NCT01179334|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
205331|NCT01179191|B1|Baseline|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205332|NCT01179191|P1|Participant Flow|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205333|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205334|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205335|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205336|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205337|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205338|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205339|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205340|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205341|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205342|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205343|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205344|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205345|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205346|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205347|NCT01179191|E1|Reported Event|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
205348|NCT01179113|B3|Baseline|Total|Total of all reporting groups
205349|NCT01179113|B2|Baseline|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205350|NCT01179113|B1|Baseline|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205351|NCT01179113|P2|Participant Flow|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205352|NCT01179113|P1|Participant Flow|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205353|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205354|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
205355|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
205364|NCT01178853|P2|Participant Flow|Rosuvastatin/Pitavastatin|
205371|NCT01178827|B3|Baseline|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205372|NCT01178827|B2|Baseline|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205373|NCT01178827|B1|Baseline|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205374|NCT01178827|P3|Participant Flow|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205375|NCT01178827|P2|Participant Flow|Oxybutynin IR|Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
205376|NCT01178827|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride), 60mg once daily for 10 days
205377|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205378|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205379|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205380|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205381|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205382|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205383|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205384|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205385|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205386|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205387|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205388|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205389|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205390|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205391|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205392|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205393|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205394|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205395|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205396|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205397|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205398|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205399|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205400|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205401|NCT01178827|E3|Reported Event|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
205402|NCT01178827|E2|Reported Event|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
205403|NCT01178827|E1|Reported Event|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
205404|NCT01178762|B1|Baseline|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
205405|NCT01178762|P1|Participant Flow|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
205406|NCT01178762|O1|Outcome|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
205407|NCT01178762|E1|Reported Event|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
205408|NCT01178671|B3|Baseline|Total|Total of all reporting groups
205409|NCT01178671|B2|Baseline|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205410|NCT01178671|B1|Baseline|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205411|NCT01178671|P2|Participant Flow|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205448|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205449|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
205450|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
205412|NCT01178671|P1|Participant Flow|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205413|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205414|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205415|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205416|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205417|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205418|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205419|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205420|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205421|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205422|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205423|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205424|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205425|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205426|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205427|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205428|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205429|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205430|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205431|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205432|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205433|NCT01178671|E2|Reported Event|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
205434|NCT01178671|E1|Reported Event|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
205435|NCT01178528|B4|Baseline|Total|Total of all reporting groups
205436|NCT01178528|B3|Baseline|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205437|NCT01178528|B2|Baseline|Carvedilol|up to 25 mg b.i.d.
205438|NCT01178528|B1|Baseline|Ivabradine|up to 7.5 mg b.i.d.
205439|NCT01178528|P3|Participant Flow|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205440|NCT01178528|P2|Participant Flow|Carvedilol|up to 25 mg b.i.d.
205441|NCT01178528|P1|Participant Flow|Ivabradine|up to 7.5 mg b.i.d.
205442|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205443|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
205444|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
205445|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205451|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205452|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
205453|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
205454|NCT01178528|E3|Reported Event|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
205455|NCT01178528|E2|Reported Event|Carvedilol|up to 25 mg b.i.d.
205456|NCT01178528|E1|Reported Event|Ivabradine|up to 7.5 mg b.i.d.
205457|NCT01178385|B3|Baseline|Total|Total of all reporting groups
205458|NCT01178385|B2|Baseline|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205459|NCT01178385|B1|Baseline|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205460|NCT01178385|P2|Participant Flow|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205461|NCT01178385|P1|Participant Flow|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205462|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205463|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205464|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205465|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205466|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205467|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205468|NCT01178385|E2|Reported Event|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
205559|NCT01178268|B3|Baseline|Total|Total of all reporting groups
205469|NCT01178385|E1|Reported Event|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
205470|NCT01178333|B4|Baseline|Total|Total of all reporting groups
205471|NCT01178333|B3|Baseline|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205472|NCT01178333|B2|Baseline|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205473|NCT01178333|B1|Baseline|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205474|NCT01178333|P3|Participant Flow|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205475|NCT01178333|P2|Participant Flow|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205476|NCT01178333|P1|Participant Flow|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205477|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205478|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205479|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205480|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205481|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205482|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205483|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205484|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205485|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205486|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205487|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205488|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205489|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205490|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205491|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205492|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
205493|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
205494|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
205495|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
205496|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205497|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205561|NCT01178268|B1|Baseline|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205498|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205499|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205500|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205501|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205502|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205503|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205504|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205505|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205506|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205507|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205508|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205509|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205510|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205511|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205512|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205513|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205514|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205515|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205516|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205517|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205518|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205519|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205520|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205521|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205522|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205523|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205524|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205560|NCT01178268|B2|Baseline|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205525|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205526|NCT01178333|E3|Reported Event|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
205527|NCT01178333|E2|Reported Event|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
205528|NCT01178333|E1|Reported Event|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
205529|NCT01178294|B1|Baseline|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205530|NCT01178294|P1|Participant Flow|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205531|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205532|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205533|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205534|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205535|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205536|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205537|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205538|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205539|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205540|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205541|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205542|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205543|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205544|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205545|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205546|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205547|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205548|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205549|NCT01178294|E1|Reported Event|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
205550|NCT01178281|B3|Baseline|Total|Total of all reporting groups
205551|NCT01178281|B2|Baseline|Placebo (Oral Capsule)|Matching oral placebo Days 1 through Day 168
205552|NCT01178281|B1|Baseline|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
205553|NCT01178281|P2|Participant Flow|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
205554|NCT01178281|P1|Participant Flow|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
205555|NCT01178281|O2|Outcome|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
205556|NCT01178281|O1|Outcome|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
205557|NCT01178281|E2|Reported Event|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
205558|NCT01178281|E1|Reported Event|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
205562|NCT01178268|P2|Participant Flow|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205563|NCT01178268|P1|Participant Flow|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205564|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205565|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205566|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205567|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205568|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205569|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205570|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205571|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205572|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205573|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205574|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205575|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205576|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205577|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205578|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205579|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205580|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205581|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205582|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205583|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205584|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205585|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205586|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205587|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205588|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205589|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205590|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205591|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205592|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205593|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205594|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205595|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205596|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205597|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205598|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205599|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205600|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205601|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205602|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205603|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205604|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205605|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205606|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205607|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205608|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205609|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205610|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205611|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205612|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205613|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205614|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205615|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205616|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205617|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205618|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205619|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205620|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205621|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205622|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205623|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205624|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205625|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205626|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205627|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205628|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205629|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205630|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205631|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205632|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205633|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205634|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205635|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205636|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205637|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205638|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205639|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205640|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205641|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205642|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205643|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205644|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205645|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205646|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205647|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205648|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205649|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205650|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205651|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205652|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205653|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205654|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205655|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205656|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205657|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205658|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205659|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205660|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205661|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205662|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205663|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205664|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205665|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205666|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205667|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205668|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205669|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205670|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205671|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205672|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205673|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205674|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205675|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205676|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205677|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205678|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205679|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205680|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205681|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205682|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205683|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205684|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205685|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205686|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205687|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205688|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205689|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205690|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205691|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205692|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205693|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205694|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205695|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205696|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205697|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205698|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205699|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205700|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205701|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205702|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205703|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205704|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205705|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205706|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205707|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205708|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205709|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205710|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205711|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205712|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205713|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205714|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205715|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205716|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205717|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205718|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205719|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205720|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205721|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205722|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205723|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205724|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205725|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205726|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205727|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205728|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205729|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205730|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205731|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205732|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205733|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205734|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205735|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205736|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205737|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205738|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205739|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205740|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205741|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205742|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205743|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205744|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205745|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205746|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205747|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205748|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205749|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205750|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205751|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205752|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205753|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205754|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205755|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205756|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205757|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205758|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205759|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205760|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205761|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205762|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205763|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205764|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205765|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205766|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205767|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205768|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205769|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205770|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205771|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205772|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205773|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205774|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205775|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205776|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205777|NCT01178268|E2|Reported Event|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
205778|NCT01178268|E1|Reported Event|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
205779|NCT01178138|B1|Baseline|Prazosin Effects on Methamphetamine|"The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 – 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg)~Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg)~Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
205780|NCT01178138|P1|Participant Flow|Prazosin Effects on Methamphetamine|"Double blind, placebo controlled study of the effect of prazosin on methamphetamine~The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
205781|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
205782|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
205783|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
205784|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
205786|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
205787|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
205788|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
205789|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
205790|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
205791|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
205792|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
205793|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
205794|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
205795|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
205796|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
205797|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
205798|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
205799|NCT01178138|E1|Reported Event|Prazosin Effects on Methamphetamine|Randomized placebo controlled trial of prazosin effects on methamphetamine
205800|NCT01178125|B1|Baseline|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205801|NCT01178125|P1|Participant Flow|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205802|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205803|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205804|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205805|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205806|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205807|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205808|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
205809|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
205810|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205811|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
205812|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
205813|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205814|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
205815|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
205816|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205817|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
205818|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
205819|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205820|NCT01178125|O2|Outcome|DR-102: Endpoint|at Week 51 of treatment with desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205821|NCT01178125|O1|Outcome|DR-102: Baseline|prior to starting desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205822|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205823|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
205824|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
205825|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205826|NCT01178125|E1|Reported Event|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
205827|NCT01178099|B5|Baseline|Total|Total of all reporting groups
205828|NCT01178099|B4|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205829|NCT01178099|B3|Baseline|Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
205830|NCT01178099|B2|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Healthy)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205945|NCT01177228|P3|Participant Flow|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
225942|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
205831|NCT01178099|B1|Baseline|Prasugrel 10 mg SD; 5 mg MD (Healthy)|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
205832|NCT01178099|P2|Participant Flow|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205833|NCT01178099|P1|Participant Flow|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205834|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205835|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205836|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205837|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205838|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205839|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205840|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205841|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205842|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205843|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205844|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205845|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205846|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205847|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205848|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205849|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205850|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205851|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205852|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205853|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205854|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205855|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205856|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205946|NCT01177228|P2|Participant Flow|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
206609|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
205857|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205858|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205859|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205860|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205861|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205862|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205863|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
205864|NCT01178099|E6|Reported Event|All Prasugrel Sickle Cell Disease Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205865|NCT01178099|E5|Reported Event|Prasugrel 10/7.5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205866|NCT01178099|E4|Reported Event|Prasugrel 10/5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD).
205867|NCT01178099|E3|Reported Event|All Prasugrel Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205868|NCT01178099|E2|Reported Event|Prasugrel 10/7.5 mg Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
205869|NCT01178099|E1|Reported Event|Prasugrel 10/5 mg Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
205870|NCT01178073|B4|Baseline|Total|Total of all reporting groups
205871|NCT01178073|B3|Baseline|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205872|NCT01178073|B2|Baseline|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205873|NCT01178073|B1|Baseline|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205874|NCT01178073|P3|Participant Flow|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205875|NCT01178073|P2|Participant Flow|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205876|NCT01178073|P1|Participant Flow|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205877|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205878|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205947|NCT01177228|P1|Participant Flow|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
205879|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205880|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205881|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205882|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205883|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205884|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205885|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205886|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205887|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205888|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205889|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205890|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205891|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205892|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205893|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205894|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205895|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205896|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205897|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205898|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205899|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205900|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205901|NCT01178073|E3|Reported Event|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
205902|NCT01178073|E2|Reported Event|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205903|NCT01178073|E1|Reported Event|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
205904|NCT01177969|B3|Baseline|Total|Total of all reporting groups
205905|NCT01177969|B2|Baseline|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
205906|NCT01177969|B1|Baseline|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
205907|NCT01177969|P2|Participant Flow|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
205948|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205949|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205950|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
225943|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
205908|NCT01177969|P1|Participant Flow|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
205909|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
205910|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
205911|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
205912|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
205913|NCT01177969|E2|Reported Event|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
205914|NCT01177969|E1|Reported Event|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
205915|NCT01177956|B1|Baseline|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205916|NCT01177956|P1|Participant Flow|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205917|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205918|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205919|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205920|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205951|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
205952|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205953|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205921|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205922|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205923|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205924|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205925|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
205926|NCT01177956|E2|Reported Event|Cetuximab + Cisplatin + 5-FU : Late Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. Participants with end of treatment date after the last trial treatment date + 30 days or still on trial at the cut-off date.
205927|NCT01177956|E1|Reported Event|Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. On or after the first dosing day of trial treatment and until 30 days after the last trial treatment administration.
205928|NCT01177943|B3|Baseline|Total|Total of all reporting groups
205929|NCT01177943|B2|Baseline|Atomoxetine Capsule Followed by Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
205930|NCT01177943|B1|Baseline|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
205931|NCT01177943|P2|Participant Flow|Atomoxetine Capsule Formulation First, Then Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
205932|NCT01177943|P1|Participant Flow|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
205933|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
205934|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
205935|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
205936|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
205937|NCT01177943|E2|Reported Event|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
205938|NCT01177943|E1|Reported Event|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
205939|NCT01177228|B5|Baseline|Total|Total of all reporting groups
205940|NCT01177228|B4|Baseline|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205941|NCT01177228|B3|Baseline|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
205942|NCT01177228|B2|Baseline|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205943|NCT01177228|B1|Baseline|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
205944|NCT01177228|P4|Participant Flow|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
205954|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205955|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
205956|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205957|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205958|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205959|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
205960|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205961|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205962|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205963|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
205964|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205965|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205966|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205967|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205968|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205969|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205970|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205971|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205972|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205973|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205974|NCT01177228|O2|Outcome|Vedolizumab (6 mg/kg)|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205975|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205976|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205977|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205978|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205979|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
205980|NCT01177228|E4|Reported Event|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
205981|NCT01177228|E3|Reported Event|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
205982|NCT01177228|E2|Reported Event|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
205983|NCT01177228|E1|Reported Event|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
205984|NCT01177098|B3|Baseline|Total|Total of all reporting groups
205985|NCT01177098|B2|Baseline|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205986|NCT01177098|B1|Baseline|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205987|NCT01177098|P2|Participant Flow|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205988|NCT01177098|P1|Participant Flow|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205989|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205990|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205991|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205992|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205993|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205994|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205995|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205996|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205997|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
205998|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
205999|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
206000|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
206001|NCT01177098|E2|Reported Event|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
206002|NCT01177098|E1|Reported Event|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
206003|NCT01177813|B6|Baseline|Total|Total of all reporting groups
206004|NCT01177813|B5|Baseline|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
206005|NCT01177813|B4|Baseline|Sitagliptin 100|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206006|NCT01177813|B3|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206007|NCT01177813|B2|Baseline|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206008|NCT01177813|B1|Baseline|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206009|NCT01177813|P5|Participant Flow|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
206010|NCT01177813|P4|Participant Flow|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206011|NCT01177813|P3|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206012|NCT01177813|P2|Participant Flow|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206013|NCT01177813|P1|Participant Flow|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206014|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
206015|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206016|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206017|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206018|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206019|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
206020|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206021|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206022|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206023|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206024|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
206025|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206026|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206027|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206028|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206029|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
206030|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206031|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206032|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206033|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206034|NCT01177813|E5|Reported Event|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
206035|NCT01177813|E4|Reported Event|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
206036|NCT01177813|E3|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
206037|NCT01177813|E2|Reported Event|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
206038|NCT01177813|E1|Reported Event|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
206039|NCT01177800|B3|Baseline|Total|Total of all reporting groups
206040|NCT01177800|B2|Baseline|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206041|NCT01177800|B1|Baseline|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206042|NCT01177800|P2|Participant Flow|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206043|NCT01177800|P1|Participant Flow|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206044|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206045|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206046|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206047|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206048|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206049|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206050|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206051|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206052|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206053|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206054|NCT01177800|E2|Reported Event|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
206055|NCT01177800|E1|Reported Event|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
206056|NCT01177735|B1|Baseline|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
206057|NCT01177735|P1|Participant Flow|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
206058|NCT01177735|O1|Outcome|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
206059|NCT01177735|E1|Reported Event|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
206060|NCT01177722|B5|Baseline|Total|Total of all reporting groups
206061|NCT01177722|B4|Baseline|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206343|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
225944|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
206062|NCT01177722|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206063|NCT01177722|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206064|NCT01177722|B1|Baseline|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206065|NCT01177722|P4|Participant Flow|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206066|NCT01177722|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206067|NCT01177722|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206068|NCT01177722|P1|Participant Flow|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206069|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206070|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206071|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206072|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206073|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206074|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206110|NCT01177553|O1|Outcome|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
206554|NCT01175590|B2|Baseline|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206075|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206076|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206077|NCT01177722|O4|Outcome|Infanrix Hexa™|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206078|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206079|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206080|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206081|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206082|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206083|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206084|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206085|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206086|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206087|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206155|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206156|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206157|NCT01177293|E2|Reported Event|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206158|NCT01177293|E1|Reported Event|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206088|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206089|NCT01177722|E4|Reported Event|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206090|NCT01177722|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206091|NCT01177722|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206092|NCT01177722|E1|Reported Event|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
206093|NCT01177709|B1|Baseline|Metformin|Metformin: metformin 500- 2500 mg/day.
206094|NCT01177709|P1|Participant Flow|Metformin|Metformin: metformin 500- 2500 mg/day.
206095|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
206096|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
206097|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
206098|NCT01177709|E1|Reported Event|Metformin|Metformin: metformin 500- 2500 mg/day.
206099|NCT01177670|B1|Baseline|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
206100|NCT01177670|P1|Participant Flow|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
206101|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
206102|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
206103|NCT01177670|E1|Reported Event|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
206104|NCT01177553|B3|Baseline|Total|Total of all reporting groups
206105|NCT01177553|B2|Baseline|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient’s perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
206106|NCT01177553|B1|Baseline|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
206107|NCT01177553|P2|Participant Flow|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
206108|NCT01177553|P1|Participant Flow|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
206109|NCT01177553|O2|Outcome|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
206159|NCT01176968|B3|Baseline|Total|Total of all reporting groups
206160|NCT01176968|B2|Baseline|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
225945|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
206111|NCT01177553|E2|Reported Event|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
206112|NCT01177553|E1|Reported Event|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
206113|NCT01177410|B4|Baseline|Total|Total of all reporting groups
206114|NCT01177410|B3|Baseline|Placebo|Placebo : placebo capsules once daily for 12 weeks
206115|NCT01177410|B2|Baseline|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
206116|NCT01177410|B1|Baseline|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
206117|NCT01177410|P3|Participant Flow|Placebo|Placebo : placebo capsules once daily for 12 weeks
206118|NCT01177410|P2|Participant Flow|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
206119|NCT01177410|P1|Participant Flow|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
206120|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
206121|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
206122|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
206123|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
206124|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
206125|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
206126|NCT01177410|E3|Reported Event|Placebo|Placebo : placebo capsules once daily for 12 weeks
206127|NCT01177410|E2|Reported Event|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
206128|NCT01177410|E1|Reported Event|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
206129|NCT01177384|B3|Baseline|Total|Total of all reporting groups
206130|NCT01177384|B2|Baseline|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206131|NCT01177384|B1|Baseline|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206132|NCT01177384|P2|Participant Flow|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206133|NCT01177384|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206134|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206135|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206136|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206137|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206138|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206139|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206140|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206141|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206142|NCT01177384|E2|Reported Event|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
206143|NCT01177384|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
206144|NCT01177293|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
206145|NCT01177293|P2|Participant Flow|Amlodipine ODT Then Amlodipine Capsule|Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
206146|NCT01177293|P1|Participant Flow|Amlodipine Capsule Then Amlodipine ODT|Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.
206147|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206148|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206149|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206150|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206151|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206152|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206153|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
206154|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
206161|NCT01176968|B1|Baseline|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206162|NCT01176968|P2|Participant Flow|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206163|NCT01176968|P1|Participant Flow|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206164|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206165|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206166|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206167|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206168|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206169|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206170|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206171|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206172|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206173|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206174|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206175|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206176|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206177|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206178|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206179|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206180|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206181|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206182|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206183|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206184|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206185|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206186|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206187|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206188|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206189|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206190|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206191|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206192|NCT01176968|E2|Reported Event|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
206193|NCT01176968|E1|Reported Event|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
206194|NCT01176955|B3|Baseline|Total|Total of all reporting groups
206195|NCT01176955|B2|Baseline|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
206196|NCT01176955|B1|Baseline|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
206197|NCT01176955|P2|Participant Flow|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
206198|NCT01176955|P1|Participant Flow|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
206199|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
206200|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
206201|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
206202|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
206203|NCT01176955|O2|Outcome|Control|Patients received standard-of-care therapy without weekly Internet surveys.
206204|NCT01176955|O1|Outcome|Internet Survey|Patients received a weekly Internet survey to report on the status of their acne.
206205|NCT01176955|E2|Reported Event|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
206206|NCT01176955|E1|Reported Event|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
206207|NCT01176877|B1|Baseline|Keloid Scar|Those with a diagnosis of keloid scar.
206208|NCT01176877|P1|Participant Flow|Keloid Scar|Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.
206209|NCT01176877|O1|Outcome|Keloid Scars|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. 3 months after the educational lecture, subjects completed an identical verbal questionnaire to assess knowledge about keloid scars.
206210|NCT01176877|O1|Outcome|Keloid Scar|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
206211|NCT01176877|E1|Reported Event|Keloid Scar|
206212|NCT01176773|B1|Baseline|Juvéderm® Ultra Lip Injectable Gel|
206213|NCT01176773|P1|Participant Flow|Juvéderm® Ultra Lip Injectable Gel|
206214|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
206215|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
206216|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
206217|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
206218|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
206219|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
206220|NCT01176773|E1|Reported Event|Juvéderm® Ultra Lip Injectable Gel|
206221|NCT01176513|B1|Baseline|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
206222|NCT01176513|P1|Participant Flow|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
206223|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
206224|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
206225|NCT01176513|E1|Reported Event|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
206226|NCT01176448|B1|Baseline|Patients With Scars|12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion.
206279|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206280|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206281|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206227|NCT01176448|P1|Participant Flow|Patients With Scars|"12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.~The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal–epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis."
206228|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. 6 patients had 12 scars treated (2 scars per patient.
206229|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser. 6 patients had 12 scars treated (2 scars per patient.
206230|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
206231|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
206232|NCT01176448|E2|Reported Event|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
206233|NCT01176448|E1|Reported Event|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
206234|NCT01176292|B3|Baseline|Total|Total of all reporting groups
206235|NCT01176292|B2|Baseline|Rotating Platform Cruciate Substituting TKA|
206236|NCT01176292|B1|Baseline|Rotating Platform High-Flex Cruciate Substituting TKA|
206237|NCT01176292|P2|Participant Flow|Rotating Platform Cruciate Substituting TKA|
206238|NCT01176292|P1|Participant Flow|Rotating Platform High-Flex Cruciate Substituting TKA|
206239|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206240|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206241|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206242|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206243|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206244|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206245|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206246|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206247|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206248|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206249|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206250|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206251|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
206252|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
206253|NCT01176292|E2|Reported Event|Rotating Platform Cruciate Substituting TKA|
206254|NCT01176292|E1|Reported Event|Rotating Platform High-Flex Cruciate Substituting TKA|
206255|NCT01176240|B5|Baseline|Total|Total of all reporting groups
206256|NCT01176240|B4|Baseline|Study 306B: Placebo|"Placebo matched control~Placebo: Placebo"
206257|NCT01176240|B3|Baseline|Study 306B: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206258|NCT01176240|B2|Baseline|Study 306A: Placebo|"Placebo matched control~Placebo: Placebo"
206259|NCT01176240|B1|Baseline|Study 306A: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206260|NCT01176240|P2|Participant Flow|Placebo|"Placebo matched control~Placebo: Placebo"
206261|NCT01176240|P1|Participant Flow|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206262|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206263|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206264|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206265|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206266|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206267|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206268|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206269|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206270|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206271|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206272|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206273|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206274|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206275|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206276|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206277|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
206278|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
206282|NCT01176240|E2|Reported Event|Placebo|"Placebo matched control~Placebo: Placebo~Placebo Safety set excludes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
206283|NCT01176240|E1|Reported Event|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment~Droxidopa Safety set includes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
206284|NCT01176058|B3|Baseline|Total|Total of all reporting groups
206285|NCT01176058|B2|Baseline|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206286|NCT01176058|B1|Baseline|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206287|NCT01176058|P2|Participant Flow|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant’s tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206288|NCT01176058|P1|Participant Flow|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206289|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206290|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206291|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206292|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206293|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206294|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206295|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206296|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206297|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206298|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206299|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206300|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206301|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206302|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206303|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206304|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206610|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206305|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206306|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206307|NCT01176058|E2|Reported Event|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206308|NCT01176058|E1|Reported Event|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
206309|NCT01176032|B3|Baseline|Total|Total of all reporting groups
206310|NCT01176032|B2|Baseline|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206311|NCT01176032|B1|Baseline|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206312|NCT01176032|P2|Participant Flow|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206313|NCT01176032|P1|Participant Flow|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206314|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206315|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206316|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206317|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206318|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206319|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206320|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206321|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206322|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206323|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206324|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206325|NCT01176032|O3|Outcome|Losartan|losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206326|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206327|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206328|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206329|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206330|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206331|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206332|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206333|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206334|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206335|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206336|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206337|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206338|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206339|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206340|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206341|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206342|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206344|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206345|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206346|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206347|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206348|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206349|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206350|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
206351|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206352|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206353|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206354|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206355|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206356|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206357|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206358|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206359|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206360|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206361|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206362|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206363|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206364|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206365|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206366|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206367|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206368|NCT01176032|E2|Reported Event|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
206369|NCT01176032|E1|Reported Event|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
206370|NCT01175902|B3|Baseline|Total|Total of all reporting groups
206371|NCT01175902|B2|Baseline|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206372|NCT01175902|B1|Baseline|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206373|NCT01175902|P2|Participant Flow|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206374|NCT01175902|P1|Participant Flow|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206375|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206376|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206377|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206378|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206379|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206380|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206381|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206382|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206383|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206384|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206385|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206386|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206387|NCT01175902|E2|Reported Event|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206388|NCT01175902|E1|Reported Event|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
206389|NCT01175850|B3|Baseline|Total|Total of all reporting groups
206390|NCT01175850|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206391|NCT01175850|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206392|NCT01175850|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
206393|NCT01175850|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
206394|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206395|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206396|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206397|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206398|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206399|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206400|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206401|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206402|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206403|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206404|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206405|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206406|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206407|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206408|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206409|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206410|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206411|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206412|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206413|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206414|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206415|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206416|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206417|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206418|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206419|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206420|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206421|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206422|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206423|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206424|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206425|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206426|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
206427|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206428|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
206429|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206430|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206431|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
206432|NCT01175850|E2|Reported Event|Standard PTA|"Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty~PTA Balloon: Balloon Angioplasty: balloon dilatation and provisional stenting with standard non-coated PTA balloon"
206433|NCT01175850|E1|Reported Event|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~Drug-Coated Balloon (DCB): balloon dilatation and provisional stenting with IN.PACT DCB"
206434|NCT01175824|B3|Baseline|Total|Total of all reporting groups
206435|NCT01175824|B2|Baseline|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206436|NCT01175824|B1|Baseline|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206437|NCT01175824|P2|Participant Flow|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206438|NCT01175824|P1|Participant Flow|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206439|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206440|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206441|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206611|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206442|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206443|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206444|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206445|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206446|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206447|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206448|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206449|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206450|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206451|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206452|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206453|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206454|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206455|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206456|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206457|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206458|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206459|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206460|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206461|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206462|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206463|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206464|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206465|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206466|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206467|NCT01175824|E2|Reported Event|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
206468|NCT01175824|E1|Reported Event|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
206469|NCT01175811|B3|Baseline|Total|Total of all reporting groups
206470|NCT01175811|B2|Baseline|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206471|NCT01175811|B1|Baseline|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206472|NCT01175811|P2|Participant Flow|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206473|NCT01175811|P1|Participant Flow|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206474|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206475|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206476|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206477|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206478|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206479|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206480|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206481|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206482|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206483|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206484|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206485|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206486|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206487|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206488|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206489|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206490|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206491|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206492|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206493|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206494|NCT01175811|E2|Reported Event|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
206495|NCT01175811|E1|Reported Event|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
206496|NCT01175798|B3|Baseline|Total|Total of all reporting groups
206497|NCT01175798|B2|Baseline|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
206498|NCT01175798|B1|Baseline|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
206499|NCT01175798|P2|Participant Flow|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
206500|NCT01175798|P1|Participant Flow|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
206501|NCT01175798|O2|Outcome|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
206502|NCT01175798|O1|Outcome|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
206503|NCT01175798|E2|Reported Event|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
206504|NCT01175798|E1|Reported Event|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
206505|NCT01175707|B3|Baseline|Total|Total of all reporting groups
206506|NCT01175707|B2|Baseline|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206507|NCT01175707|B1|Baseline|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206508|NCT01175707|P2|Participant Flow|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206509|NCT01175707|P1|Participant Flow|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206510|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206511|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206512|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206513|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206514|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206515|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206516|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206517|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206518|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206519|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206520|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206521|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206522|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206523|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206555|NCT01175590|B1|Baseline|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206524|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206525|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206526|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206527|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206528|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206529|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
206530|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206531|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206532|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206533|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206534|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206535|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206536|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206537|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206538|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206539|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206540|NCT01175707|E2|Reported Event|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
206541|NCT01175707|E1|Reported Event|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
206542|NCT01175668|B3|Baseline|Total|Total of all reporting groups
206543|NCT01175668|B2|Baseline|NMS/Phenobarbital|
206544|NCT01175668|B1|Baseline|NMS/Clonidine|
206545|NCT01175668|P2|Participant Flow|NMS/Phenobarbital|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
206546|NCT01175668|P1|Participant Flow|NMS/Clonidine|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
206547|NCT01175668|O2|Outcome|NMS/Phenobarbital|
206548|NCT01175668|O1|Outcome|NMS/Clonidine|
206549|NCT01175668|O2|Outcome|NMS/Phenobarbital|
206550|NCT01175668|O1|Outcome|NMS/Clonidine|
206551|NCT01175668|E2|Reported Event|NMS/Phenobarbital|
206552|NCT01175668|E1|Reported Event|NMS/Clonidine|
206553|NCT01175590|B3|Baseline|Total|Total of all reporting groups
206556|NCT01175590|P2|Participant Flow|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206557|NCT01175590|P1|Participant Flow|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206558|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206559|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206560|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206561|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206562|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206563|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206564|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206565|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206566|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206567|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206568|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206569|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206570|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206571|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206572|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206573|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206574|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206575|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206576|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206577|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206578|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206579|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206580|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206581|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206582|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206583|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206584|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206585|NCT01175590|O1|Outcome|Besivance|besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days
206586|NCT01175590|E2|Reported Event|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
206587|NCT01175590|E1|Reported Event|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
206588|NCT01175473|B3|Baseline|Total|Total of all reporting groups
206589|NCT01175473|B2|Baseline|Liraglutide|2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
206590|NCT01175473|B1|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
206591|NCT01175473|P2|Participant Flow|Liraglutide|2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
206592|NCT01175473|P1|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
206593|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206594|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206595|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206596|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206597|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206598|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206599|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206600|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206601|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206602|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206603|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206604|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206605|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206606|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206607|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
206608|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206612|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
206613|NCT01175473|E2|Reported Event|Liraglutide|2-step initiation regimen of liraglutide.
206614|NCT01175473|E1|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
206615|NCT01175434|B3|Baseline|Total|Total of all reporting groups
206616|NCT01175434|B2|Baseline|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
206617|NCT01175434|B1|Baseline|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
206618|NCT01175434|P2|Participant Flow|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
206619|NCT01175434|P1|Participant Flow|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
206620|NCT01175434|O2|Outcome|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
206621|NCT01175434|O1|Outcome|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
206622|NCT01175434|E2|Reported Event|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
206623|NCT01175434|E1|Reported Event|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
206624|NCT01175395|B1|Baseline|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
206625|NCT01175395|P1|Participant Flow|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
206626|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
206627|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
206628|NCT01175395|E1|Reported Event|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
206629|NCT01175369|B3|Baseline|Total|Total of all reporting groups
206630|NCT01175369|B2|Baseline|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
206631|NCT01175369|B1|Baseline|Usual Care|Usual asthma care
206632|NCT01175369|P2|Participant Flow|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
206633|NCT01175369|P1|Participant Flow|Usual Care|Usual asthma care
206634|NCT01175369|O2|Outcome|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
206635|NCT01175369|O1|Outcome|Usual Care|Usual asthma care
206636|NCT01175369|E2|Reported Event|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
206637|NCT01175369|E1|Reported Event|Usual Care|Usual asthma care
206638|NCT01175317|B3|Baseline|Total|Total of all reporting groups
206639|NCT01175317|B2|Baseline|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
206640|NCT01175317|B1|Baseline|Goald-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
206641|NCT01175317|P2|Participant Flow|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
206642|NCT01175317|P1|Participant Flow|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
206643|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
206644|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
206645|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
206646|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
206647|NCT01175317|E2|Reported Event|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
206648|NCT01175317|E1|Reported Event|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
206649|NCT01175213|B5|Baseline|Total|Total of all reporting groups
206650|NCT01175213|B4|Baseline|Participants Aged 65 Years and Older|
206651|NCT01175213|B3|Baseline|Participants Aged 16 to <65 Years|
206652|NCT01175213|B2|Baseline|Participants Aged 12 to <16 Years|
206653|NCT01175213|B1|Baseline|Participants Aged 2 to <12 Years|
206654|NCT01175213|P2|Participant Flow|IGIV, 10% Only|"Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study.~Note: IGIV, 10% is the same product as IGSC, 10%."
206655|NCT01175213|P1|Participant Flow|IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only|"Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator.~Note: IGIV, 10% is the same product as IGSC, 10%."
206656|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206657|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206658|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206659|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206660|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206661|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206662|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206663|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206679|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206748|NCT01175005|O2|Outcome|Blood Culture Negative|Procalcitonin level in patients with fever and a CVC with negative blood culture
206749|NCT01175005|O1|Outcome|Blood Culture Positive|Procalcitonin level in patients with fever and a CVC with positive blood culture
206750|NCT01175005|E1|Reported Event|Fever and a Central Venous Catheter|
206664|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206665|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206666|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206667|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206668|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206669|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206670|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206671|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206672|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206673|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206674|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206675|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206676|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206677|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206678|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206741|NCT01175018|O1|Outcome|Anakinra|"Anakinra 100 mg injectable subcutaneously daily~Anakinra: Anakinra 100 mg s.c. daily for 14 days"
206680|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206681|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206682|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206683|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206684|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
206685|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
206686|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
206687|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
206688|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206689|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206690|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206691|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206692|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206693|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206694|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20 and/or IGSC, 10%|"All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20).~This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only.~Number of participants in each treatment interval [N] is provided."
206695|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
206696|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
206742|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206743|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206744|NCT01175018|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
206745|NCT01175018|E1|Reported Event|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206746|NCT01175005|B1|Baseline|Fever and a Central Venous Catheter|
206747|NCT01175005|P1|Participant Flow|Fever and a Central Venous Catheter|
206697|NCT01175213|E2|Reported Event|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
206698|NCT01175213|E1|Reported Event|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
206699|NCT01175031|B1|Baseline|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
206700|NCT01175031|P1|Participant Flow|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
206701|NCT01175031|O1|Outcome|Device-Detected Clear Airway Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
206702|NCT01175031|O1|Outcome|Device-Detected Obstructive Airway Apneas|Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
206703|NCT01175031|O1|Outcome|Device-Detected Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
206704|NCT01175031|O2|Outcome|Manually Scored Polysomnography (PSG)|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
206705|NCT01175031|O1|Outcome|REMstar Auto With A-Flex|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
206706|NCT01175031|E1|Reported Event|Subjects With Sleep Apnea|Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
206707|NCT01175018|B3|Baseline|Total|Total of all reporting groups
206708|NCT01175018|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
206709|NCT01175018|B1|Baseline|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206710|NCT01175018|P2|Participant Flow|Placebo|0.67 ml of sodium chloride (NaCl) 0.9% solution
206711|NCT01175018|P1|Participant Flow|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206712|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206713|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206714|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206715|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206716|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206717|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206718|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206719|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206720|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206721|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206722|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206723|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206724|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206725|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206726|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206727|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206728|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206729|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206730|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206731|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206732|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206733|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206734|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206735|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206736|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206737|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206738|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
206739|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
206740|NCT01175018|O2|Outcome|Placebo|"0.67 ml of NaCl 0.9% solution~Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days"
206751|NCT01174784|B1|Baseline|Enrolled/Primary Cohort|
206757|NCT01174576|P1|Participant Flow|Caffeinated Coffee/Decaffeinated Coffee/Water|"200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order.~Three combinations of treatment sequences were used:~Caffeinated coffee, then decaffeinated coffee, then water~Decaffeinated coffee first, then water, then caffeinated coffee~Water first, then caffeinated coffee, then decaffeinated coffee.~Each treatment was separated by the other by at least one week interval.~The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc."
206758|NCT01174576|O3|Outcome|Water|200 mL
206759|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206760|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206761|NCT01174576|O3|Outcome|Water|200 mL
206762|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206763|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206764|NCT01174576|O3|Outcome|Water|200 mL
206765|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206766|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206767|NCT01174576|O3|Outcome|Water|200 ml water
206768|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
206769|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
206770|NCT01174576|O3|Outcome|Water|200 mL
206771|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206772|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/ kg body weight
206773|NCT01174576|O3|Outcome|Water|200 ml water
206774|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
206775|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
206776|NCT01174576|O3|Outcome|Water|200 mL
206777|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206778|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206779|NCT01174576|O3|Outcome|Water|200 mL
206780|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeineated coffee
206781|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206782|NCT01174576|O3|Outcome|Water|200 mL
206783|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206784|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206785|NCT01174576|O3|Outcome|Water|200 mL
206786|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206787|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206788|NCT01174576|O3|Outcome|Water|200 mL
206789|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206790|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206791|NCT01174576|O3|Outcome|Water|200 mL
206792|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
206793|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
206794|NCT01174576|E3|Reported Event|Water|200 mL
206795|NCT01174576|E2|Reported Event|Decaffeinated Coffee|200 mL decaffeinated coffee, same amount as caffeinated coffee
206796|NCT01174576|E1|Reported Event|Caffeinated Coffee|200 mL, coffee containing 3 mg caffeine/kg body weight
206797|NCT01174550|B3|Baseline|Total|Total of all reporting groups
206798|NCT01174550|B2|Baseline|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206799|NCT01174550|B1|Baseline|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206800|NCT01174550|P2|Participant Flow|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206801|NCT01174550|P1|Participant Flow|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206802|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206803|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206804|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206805|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206806|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206807|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206885|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206808|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206809|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206810|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206811|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206812|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206813|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206814|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206815|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206816|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206817|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206818|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206819|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206820|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206821|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206822|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206823|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206824|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206825|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206826|NCT01174550|E2|Reported Event|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
206827|NCT01174550|E1|Reported Event|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
206828|NCT01174459|B1|Baseline|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
206829|NCT01174459|P1|Participant Flow|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
206830|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
206831|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
206832|NCT01174459|E1|Reported Event|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
206833|NCT01174446|B1|Baseline|All Study Participants Who Received Study Drug|"BAX326 : -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
206834|NCT01174446|P4|Participant Flow|Study Part 2 Only: BAX326 On-Demand|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
206835|NCT01174446|P3|Participant Flow|Study Part 2 Only: BAX326 Prophylaxis|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
206836|NCT01174446|P2|Participant Flow|PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BeneFIX (75 ± 5 IU/kg) then BAX326 (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
206886|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206887|NCT01174446|O5|Outcome|On-Demand: End of Study|
207009|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
207010|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
206837|NCT01174446|P1|Participant Flow|PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 (75 ± 5 IU/kg) then BeneFIX (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
206838|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206839|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206840|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206841|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206842|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206843|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206844|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206845|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206846|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206847|NCT01174446|O3|Outcome|Change From Baseline|
206848|NCT01174446|O2|Outcome|End of Study|
206849|NCT01174446|O1|Outcome|Part 1 or Part 2, Exposure Day 1 (Baseline)|
206850|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206851|NCT01174446|O5|Outcome|On-Demand: End of Study|
206852|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206853|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206854|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206855|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206856|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206857|NCT01174446|O5|Outcome|On-Demand: End of Study|
206915|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206858|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206859|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206860|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206861|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206862|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206863|NCT01174446|O5|Outcome|On-Demand: End of Study|
206864|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206865|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206866|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206867|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206868|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206869|NCT01174446|O5|Outcome|On-Demand: End of Study|
206870|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206871|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206872|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206873|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206874|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206875|NCT01174446|O5|Outcome|On-Demand: End of Study|
206876|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206877|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206878|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206879|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206880|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206881|NCT01174446|O5|Outcome|On-Demand: End of Study|
206882|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206883|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206884|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206888|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206889|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206890|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206891|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206892|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206893|NCT01174446|O5|Outcome|On-Demand: End of Study|
206894|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206895|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206896|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206897|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206898|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206899|NCT01174446|O5|Outcome|On-Demand: End of Study|
206900|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206901|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206902|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206903|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206904|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206905|NCT01174446|O5|Outcome|On-Demand: End of Study|
206906|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206907|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206908|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206909|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206910|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206911|NCT01174446|O5|Outcome|On-Demand: End of Study|
206912|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206913|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206914|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206918|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206919|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206920|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206921|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206922|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206923|NCT01174446|O5|Outcome|On-Demand: End of Study|
206924|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206925|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206926|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206927|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206928|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206929|NCT01174446|O5|Outcome|On-Demand: End of Study|
206930|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206931|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206932|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206933|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206934|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206935|NCT01174446|O5|Outcome|On-Demand: End of Study|
206936|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206937|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206938|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206939|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206940|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206941|NCT01174446|O5|Outcome|On-Demand: End of Study|
206942|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206943|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206944|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206945|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206946|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
206947|NCT01174446|O5|Outcome|On-Demand: End of Study|
206948|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
206949|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
206950|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
206951|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
206952|NCT01174446|O2|Outcome|Participants With AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
206953|NCT01174446|O1|Outcome|Participants With AEs - Not Related|
206954|NCT01174446|O2|Outcome|AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
206955|NCT01174446|O1|Outcome|AEs - Not Related|
206956|NCT01174446|O1|Outcome|All Study Participants|
206957|NCT01174446|O1|Outcome|All Study Participants|
206958|NCT01174446|O1|Outcome|All Study Participants|
206959|NCT01174446|O1|Outcome|All Study Participants|
206960|NCT01174446|O1|Outcome|All Study Participants|
206961|NCT01174446|O1|Outcome|All Study Participants|
206962|NCT01174446|O1|Outcome|All Study Participants|
206963|NCT01174446|O1|Outcome|All Study Participants|
206964|NCT01174446|O1|Outcome|All Study Participants|
206965|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
206966|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
206967|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
206968|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
206969|NCT01174446|O2|Outcome|Bleeding Treatment|Includes all participants who received any infusions for bleeding treatment in the Full Analysis Set. (ie includes all On-demand arm (N=14) and 33 participants from the prophylaxis arm who experienced a bleeding episode)
206970|NCT01174446|O1|Outcome|Prophylactic Treatment|
206971|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
206972|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
206973|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
206974|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
206975|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
206976|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
206977|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
206978|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
206979|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
206980|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
206981|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
206982|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
206983|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
206984|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
206985|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
206986|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
206987|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
206988|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
206989|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
206990|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
206991|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
206992|NCT01174446|O1|Outcome|BAX326 Prophylaxis|"Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.~Participants received a minimum of three months prophylactic treatment"
206993|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
206994|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
206995|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
206996|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
206997|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
206998|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
206999|NCT01174446|O4|Outcome|Study Completion or Termination Visit|
207000|NCT01174446|O3|Outcome|Part 2 or Part 3: Week 26|
207001|NCT01174446|O2|Outcome|Part 2: Week 13|
207002|NCT01174446|O1|Outcome|Part 2: Week 5|PK infusion with BAX326 at 75 ± 5 IU/kg
207003|NCT01174446|O5|Outcome|Study Completion or Termination Visit|
207004|NCT01174446|O4|Outcome|Part 2 or Part 3: Week 26|
207005|NCT01174446|O3|Outcome|Part 2: Week 13|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
207006|NCT01174446|O2|Outcome|Part 2: Week 5|PK infusion with BeneFIX at 75 ± 5 IU/kg
207007|NCT01174446|O1|Outcome|Part 1 or Part 2, ED 1|PK infusion with BAX326 at 75 ± 5 IU/kg
207008|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
207011|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
207012|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
207013|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
207014|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
207015|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
207016|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
207017|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
207018|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
207019|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
207020|NCT01174446|O2|Outcome|BeneFIX|
207021|NCT01174446|O1|Outcome|BAX326|
207022|NCT01174446|E1|Reported Event|BAX326|"BAX326: -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
207023|NCT01174342|B1|Baseline|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
207024|NCT01174342|P1|Participant Flow|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
207025|NCT01174342|O1|Outcome|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery
207026|NCT01174342|E1|Reported Event|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
207027|NCT01174264|B4|Baseline|Total|Total of all reporting groups
207028|NCT01174264|B3|Baseline|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207029|NCT01174264|B2|Baseline|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207030|NCT01174264|B1|Baseline|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207031|NCT01174264|P3|Participant Flow|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207032|NCT01174264|P2|Participant Flow|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207033|NCT01174264|P1|Participant Flow|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207034|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207035|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207036|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207037|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207038|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207039|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207040|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207041|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207042|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207043|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207044|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207045|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207046|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207047|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207048|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207049|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207050|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207051|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207052|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207053|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207054|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207055|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207056|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207057|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207058|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207059|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207060|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207061|NCT01174264|E3|Reported Event|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207062|NCT01174264|E2|Reported Event|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207063|NCT01174264|E1|Reported Event|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
207064|NCT01174186|B3|Baseline|Total|Total of all reporting groups
207065|NCT01174186|B2|Baseline|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
207066|NCT01174186|B1|Baseline|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
207067|NCT01174186|P2|Participant Flow|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
207068|NCT01174186|P1|Participant Flow|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
207069|NCT01174186|O2|Outcome|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
207070|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
207071|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
207072|NCT01174186|E2|Reported Event|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
207073|NCT01174186|E1|Reported Event|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
207074|NCT01174173|B1|Baseline|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207075|NCT01174173|P1|Participant Flow|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207076|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207077|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207078|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207079|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207080|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
207081|NCT01174173|E1|Reported Event|Ranolazine|Ranolazine: ranolazine 1000 mg PO BID for 3 months
207082|NCT01174160|B3|Baseline|Total|Total of all reporting groups
207083|NCT01174160|B2|Baseline|Placebo|"placebo~Up to two 10-min infusions of normal saline"
207084|NCT01174160|B1|Baseline|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
207085|NCT01174160|P2|Participant Flow|Placebo|"placebo~Up to two 10-min infusions of normal saline"
207086|NCT01174160|P1|Participant Flow|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
207087|NCT01174160|O2|Outcome|Placebo|"placebo~Up to two 10-min infusions of normal saline"
207088|NCT01174160|O1|Outcome|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
207089|NCT01174160|E2|Reported Event|Placebo|"placebo~Up to two 10-min infusions of normal saline"
207090|NCT01174160|E1|Reported Event|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
207091|NCT01174043|B1|Baseline|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207092|NCT01174043|P1|Participant Flow|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207093|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207094|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207095|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207096|NCT01174043|E1|Reported Event|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
207097|NCT01174030|B6|Baseline|Total|Total of all reporting groups
207098|NCT01174030|B5|Baseline|Vehicle Gel BID|
207099|NCT01174030|B4|Baseline|Vehicle Gel QD|
207100|NCT01174030|B3|Baseline|CD07805/47 Gel 0.18% BID|
207101|NCT01174030|B2|Baseline|CD07805/47 Gel 0.18% QD|
207102|NCT01174030|B1|Baseline|CD07805/47 Gel 0.5% QD|
207103|NCT01174030|P5|Participant Flow|Vehicle Gel BID|Vehicle Gel Twice Daily
207104|NCT01174030|P4|Participant Flow|Vehicle Gel QD|Vehicle Gel Once Daily
207105|NCT01174030|P3|Participant Flow|CD07805/47 Gel 0.18% BID|CD07805/47 Gel 0.18% Twice Daily
207106|NCT01174030|P2|Participant Flow|CD07805/47 Gel 0.18% QD|CD07805/47 Gel 0.18% Once Daily
207107|NCT01174030|P1|Participant Flow|CD07805/47 Gel 0.5% QD|CD07805/47 Gel 0.5% Once Daily
207108|NCT01174030|O5|Outcome|Vehicle Gel BID|
207109|NCT01174030|O4|Outcome|Vehicle Gel QD|
207110|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
207111|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
207112|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
207113|NCT01174030|O5|Outcome|Vehicle Gel BID|
207114|NCT01174030|O4|Outcome|Vehicle Gel QD|
207115|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
207116|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
207117|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
207118|NCT01174030|O5|Outcome|Vehicle Gel BID|
207119|NCT01174030|O4|Outcome|Vehicle Gel QD|
207120|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
207121|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
207122|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
207123|NCT01174030|E5|Reported Event|Vehicle Gel BID|
207124|NCT01174030|E4|Reported Event|Vehicle Gel QD|
207125|NCT01174030|E3|Reported Event|CD07805/47 Gel 0.18% BID|
207126|NCT01174030|E2|Reported Event|CD07805/47 Gel 0.18% QD|
207127|NCT01174030|E1|Reported Event|CD07805/47 Gel 0.5% QD|
207128|NCT01174004|B3|Baseline|Total|Total of all reporting groups
207129|NCT01174004|B2|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
207130|NCT01174004|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
207131|NCT01174004|P2|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
207132|NCT01174004|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
207133|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
207134|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
207135|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
207136|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
207137|NCT01174004|E2|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
207138|NCT01174004|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
207374|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207139|NCT01173718|B1|Baseline|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207140|NCT01173718|P1|Participant Flow|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207141|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207142|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207143|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207144|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207145|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207146|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
207147|NCT01173718|E1|Reported Event|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft
207148|NCT01173653|B3|Baseline|Total|Total of all reporting groups
207149|NCT01173653|B2|Baseline|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
207150|NCT01173653|B1|Baseline|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
207151|NCT01173653|P2|Participant Flow|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
207152|NCT01173653|P1|Participant Flow|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
207153|NCT01173653|O2|Outcome|Intervention Arm|Enrollees put in contact with 1-800-QUIT-NOW line
207154|NCT01173653|O1|Outcome|Control Arm|No intervention given to this ED population of smokers
207155|NCT01173653|E2|Reported Event|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
207156|NCT01173653|E1|Reported Event|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
207157|NCT01173471|B5|Baseline|Total|Total of all reporting groups
207158|NCT01173471|B4|Baseline|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207159|NCT01173471|B3|Baseline|Placebo BID|Placebo twice daily
207160|NCT01173471|B2|Baseline|AZD4017 200 mg OD|AZD4017 200 mg once daily
207161|NCT01173471|B1|Baseline|Placebo OD|Placebo once daily
207162|NCT01173471|P4|Participant Flow|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207163|NCT01173471|P3|Participant Flow|Placebo BID|Placebo twice daily
207164|NCT01173471|P2|Participant Flow|AZD4017 200 mg OD|AZD4017 200 mg once daily
207165|NCT01173471|P1|Participant Flow|Placebo OD|Placebo once daily
207166|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207167|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
207168|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
207169|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
207170|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207171|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
207172|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
207173|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
207174|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207175|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
207176|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
207177|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
207178|NCT01173471|E4|Reported Event|AZD4017 400 mg BID|AZD4017 400 mg twice daily
207179|NCT01173471|E3|Reported Event|Placebo BID|Placebo twice daily
207180|NCT01173471|E2|Reported Event|AZD4017 200 mg OD|AZD4017 200 mg once daily
207181|NCT01173471|E1|Reported Event|Placebo OD|Placebo once daily
207182|NCT01173211|B7|Baseline|Total|Total of all reporting groups
207183|NCT01173211|B6|Baseline|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207184|NCT01173211|B5|Baseline|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207185|NCT01173211|B4|Baseline|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207186|NCT01173211|B3|Baseline|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207187|NCT01173211|B2|Baseline|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207188|NCT01173211|B1|Baseline|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207189|NCT01173211|P6|Participant Flow|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
225946|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
207190|NCT01173211|P5|Participant Flow|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207191|NCT01173211|P4|Participant Flow|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207192|NCT01173211|P3|Participant Flow|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207193|NCT01173211|P2|Participant Flow|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207194|NCT01173211|P1|Participant Flow|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207195|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207196|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207197|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207198|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207199|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207200|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207201|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207202|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207203|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207204|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207205|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207206|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207207|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207208|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207209|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207210|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207211|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207212|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207213|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207214|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207215|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207216|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207217|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207218|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207219|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207220|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207221|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207222|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207223|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207224|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207225|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207226|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207227|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207228|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207229|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207230|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207231|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207232|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207233|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207234|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207235|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207236|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207237|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207238|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207239|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207240|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207241|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207242|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207243|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207244|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207245|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207246|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207247|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207248|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207249|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207375|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207250|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207251|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207252|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207253|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207254|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207255|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207256|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207257|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207258|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207259|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207260|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207261|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207262|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207263|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207264|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207265|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207266|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207267|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207268|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207269|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207270|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207271|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207272|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207273|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207274|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207275|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207276|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207277|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207278|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207279|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207376|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207280|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207281|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207282|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207283|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207284|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207285|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207286|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207287|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207288|NCT01173211|E6|Reported Event|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207289|NCT01173211|E5|Reported Event|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207290|NCT01173211|E4|Reported Event|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207291|NCT01173211|E3|Reported Event|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
207292|NCT01173211|E2|Reported Event|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
207293|NCT01173211|E1|Reported Event|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
207294|NCT01173120|B1|Baseline|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207295|NCT01173120|P1|Participant Flow|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207296|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207297|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207298|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207299|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207300|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207301|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207377|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207302|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207303|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207304|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207305|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207306|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207307|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207308|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207309|NCT01173120|E1|Reported Event|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
207310|NCT01173055|B3|Baseline|Total|Total of all reporting groups
207311|NCT01173055|B2|Baseline|Placebo First, Then Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207312|NCT01173055|B1|Baseline|Milnacipran First, Then Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207313|NCT01173055|P2|Participant Flow|Placebo First, Then Milnacipran|"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."
207314|NCT01173055|P1|Participant Flow|Milnacipran First, Then Placebo|"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."
207315|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207316|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207317|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207318|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207319|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207320|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207321|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207322|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207323|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207324|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207325|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207326|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
207327|NCT01173055|E2|Reported Event|Placebo|Placebo was given orally twice daily in tablet form at different times during the course of the study.
207328|NCT01173055|E1|Reported Event|Milnacipran|Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
207329|NCT01173029|B3|Baseline|Total|Total of all reporting groups
207330|NCT01173029|B2|Baseline|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207331|NCT01173029|B1|Baseline|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207332|NCT01173029|P2|Participant Flow|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207333|NCT01173029|P1|Participant Flow|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207334|NCT01173029|O9|Outcome|Polygenic Score: Eight|Sum of the weights for analyzing polymorphisms equal to eight.
207335|NCT01173029|O8|Outcome|Polygenic Score: Seven|Sum of the weights for analyzing polymorphisms equal to seven.
207336|NCT01173029|O7|Outcome|Polygenic Score: Six|Sum of the weights for analyzing polymorphisms equal to six.
207337|NCT01173029|O6|Outcome|Polygenic Score: Five|Sum of the weights for analyzing polymorphisms equal to five.
207338|NCT01173029|O5|Outcome|Polygenic Score: Four|Sum of the weights for analyzing polymorphisms equal to four.
207339|NCT01173029|O4|Outcome|Polygenic Score: Three|Sum of the weights for analyzing polymorphisms equal to three.
207340|NCT01173029|O3|Outcome|Polygenic Score: Two|Sum of the weights for analyzing polymorphisms equal to two.
207341|NCT01173029|O2|Outcome|Polygenic Score: One|Sum of the weights for analyzing polymorphisms equal to one.
207342|NCT01173029|O1|Outcome|Polygenic Score: Zero|Sum of the weights for analyzing polymorphisms equal to zero.
207343|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207344|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207345|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207346|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207347|NCT01173029|E2|Reported Event|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207348|NCT01173029|E1|Reported Event|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
207349|NCT01172938|B4|Baseline|Total|Total of all reporting groups
207350|NCT01172938|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207351|NCT01172938|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207352|NCT01172938|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207353|NCT01172938|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
207354|NCT01172938|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
207355|NCT01172938|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
207356|NCT01172938|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
207357|NCT01172938|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
207358|NCT01172938|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
207359|NCT01172938|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
207360|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207361|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207362|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207363|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207364|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207365|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207366|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207367|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207368|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207369|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207370|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207371|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207372|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207373|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207378|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207379|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207380|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207381|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207382|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207383|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207384|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207385|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207386|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207387|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207388|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207389|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207390|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207391|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207392|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207393|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207394|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207395|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207396|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207397|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207398|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207399|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207400|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207401|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207402|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207403|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207404|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207405|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207406|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207407|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207408|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207409|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207410|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207411|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207412|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207413|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207414|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207415|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207416|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207417|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207418|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207419|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207420|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207421|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207422|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207423|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207424|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207425|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207426|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
207427|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
207428|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207429|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207430|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207431|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207432|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207433|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207434|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207435|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207436|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207437|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207438|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207439|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207440|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207441|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207442|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207443|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207444|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207445|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207446|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207447|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207448|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207449|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207450|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207451|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207452|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207453|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207454|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207455|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207456|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207457|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207458|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207459|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207460|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207461|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207462|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207463|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207464|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207465|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207466|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207467|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207468|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207469|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207470|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207471|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207472|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207473|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207474|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207475|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207476|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207477|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207478|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207479|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207480|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207481|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207482|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207483|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207484|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207485|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207486|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207487|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207488|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207489|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207490|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207491|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207492|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207493|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207494|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207495|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207496|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207497|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207498|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207499|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207500|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207501|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207502|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207503|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207504|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207505|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207506|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207507|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207508|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207509|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207510|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207511|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207512|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207513|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207514|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207515|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207516|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207517|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207518|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207519|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207520|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207521|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207522|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207523|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
207524|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207525|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207526|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207527|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
207528|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
207529|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
207530|NCT01172938|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
207531|NCT01172938|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
207532|NCT01172938|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
207533|NCT01172938|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
207534|NCT01172938|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
207535|NCT01172873|B3|Baseline|Total|Total of all reporting groups
207536|NCT01172873|B2|Baseline|E/RP Alone (no DCS Administration)|Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
207537|NCT01172873|B1|Baseline|D-cycloserine + E/RP|Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
207538|NCT01172873|P2|Participant Flow|E/RP Alone (no DCS Administration)|The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
207539|NCT01172873|P1|Participant Flow|D-cycloserine + E/RP|The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
207540|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
207541|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
207542|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
207543|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
207544|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
207545|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
207546|NCT01172873|E2|Reported Event|E/RP Alone (no DCS Administration)|Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
207547|NCT01172873|E1|Reported Event|D-cycloserine + E/RP|Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
207548|NCT01172847|B1|Baseline|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
207549|NCT01172847|P1|Participant Flow|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
207550|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207551|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
207552|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207553|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207554|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
207555|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207556|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207557|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
207558|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207559|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207560|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
207561|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207562|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207563|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207564|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207565|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207566|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207567|NCT01172847|O1|Outcome|Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207568|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207569|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207570|NCT01172847|E3|Reported Event|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
207571|NCT01172847|E2|Reported Event|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
207572|NCT01172847|E1|Reported Event|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
207573|NCT01172821|B5|Baseline|Total|Total of all reporting groups
207574|NCT01172821|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207575|NCT01172821|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207576|NCT01172821|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207577|NCT01172821|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207578|NCT01172821|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207579|NCT01172821|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207580|NCT01172821|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207581|NCT01172821|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207582|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207583|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207584|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207585|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207586|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207587|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207588|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207589|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207590|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207591|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207592|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
225947|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
207593|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207594|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207595|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207596|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207597|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207598|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207599|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207600|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207601|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207602|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207603|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207604|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207605|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207606|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207607|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207608|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207609|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207610|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207611|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207612|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207613|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207614|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207615|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207616|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207617|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207618|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207619|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207620|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207621|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207622|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207623|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207624|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207625|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207626|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207627|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207628|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207629|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207630|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207631|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207632|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207633|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207634|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207635|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207636|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207637|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207638|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207639|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207640|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207641|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207642|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207643|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
225948|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
207644|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207645|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207646|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207647|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207648|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207649|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207650|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207651|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207652|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207653|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207654|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207655|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207656|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207657|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207658|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207659|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207660|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207661|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207662|NCT01172821|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207663|NCT01172821|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207664|NCT01172821|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207665|NCT01172821|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207666|NCT01172808|B5|Baseline|Total|Total of all reporting groups
207667|NCT01172808|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207668|NCT01172808|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207669|NCT01172808|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207670|NCT01172808|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207671|NCT01172808|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207672|NCT01172808|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207673|NCT01172808|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207674|NCT01172808|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207675|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207676|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207677|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207678|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207679|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207680|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207681|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207682|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207683|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207684|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207685|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207686|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207687|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207688|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207689|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207690|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207691|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207692|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207693|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207694|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207695|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207696|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207697|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207698|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207699|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207700|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207701|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207702|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207703|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207704|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207705|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207706|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207707|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207708|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207709|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207710|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207711|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207712|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207713|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207714|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207715|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207716|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207717|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207718|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207719|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207720|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207721|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207722|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207723|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207724|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207725|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207726|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207727|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207728|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207729|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207730|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207731|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207732|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207733|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207734|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207735|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207736|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207737|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207738|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207739|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207740|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207741|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207742|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207743|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207744|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207745|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
225949|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
207746|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207747|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207748|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207749|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207750|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207751|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207752|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207753|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207754|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207755|NCT01172808|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207756|NCT01172808|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
207757|NCT01172808|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
207758|NCT01172808|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
207759|NCT01172600|B3|Baseline|Total|Total of all reporting groups
207760|NCT01172600|B2|Baseline|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207761|NCT01172600|B1|Baseline|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207762|NCT01172600|P2|Participant Flow|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207763|NCT01172600|P1|Participant Flow|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207764|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207765|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207766|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207767|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207768|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207769|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207770|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207771|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207772|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207773|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207774|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207775|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207776|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207834|NCT01172353|E1|Reported Event|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
207777|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207778|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207779|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207780|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207781|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207782|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207783|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207784|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207785|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207786|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207787|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207788|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207789|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207790|NCT01172600|E2|Reported Event|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207791|NCT01172600|E1|Reported Event|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
207792|NCT01172535|B1|Baseline|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207793|NCT01172535|P1|Participant Flow|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207794|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207795|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207796|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207797|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207798|NCT01172535|O3|Outcome|Week 24|Participants bringing medication to be measured at study week 24
207799|NCT01172535|O2|Outcome|Week 12|Participants bringing medication to be measured at study week 12
207800|NCT01172535|O1|Outcome|Week 4|Participants bringing medication to be measured at study week 4
207801|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207802|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207835|NCT01172288|B3|Baseline|Total|Total of all reporting groups
207803|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207804|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207805|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207806|NCT01172535|E1|Reported Event|LPV/r|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
207807|NCT01172522|B3|Baseline|Total|Total of all reporting groups
207808|NCT01172522|B2|Baseline|Fexofenadine Left Side; Placebo Right Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Fexofenadine, placebo"
207809|NCT01172522|B1|Baseline|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Placebo, fexofenadine"
207810|NCT01172522|P2|Participant Flow|Fexofenadine Left Side; Placebo Right Side|Subjects were randomized as to side of face treated with test article versus placebo
207811|NCT01172522|P1|Participant Flow|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently."
207812|NCT01172522|O2|Outcome|Placebo|All participants that received placebo
207813|NCT01172522|O1|Outcome|Fexofenadine|All participants that received fexofenadine
207814|NCT01172522|E1|Reported Event|Split Face Intrasubject Comparison|"Topical treatment active versus placebo~Double blind randomized placebo controlled split face intrasubject comparison."
207815|NCT01172418|B3|Baseline|Total|Total of all reporting groups
207816|NCT01172418|B2|Baseline|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
207817|NCT01172418|B1|Baseline|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
207818|NCT01172418|P2|Participant Flow|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
207819|NCT01172418|P1|Participant Flow|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
207820|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
207821|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
207822|NCT01172418|E2|Reported Event|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
207823|NCT01172418|E1|Reported Event|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
207824|NCT01172353|B3|Baseline|Total|Total of all reporting groups
207825|NCT01172353|B2|Baseline|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
207826|NCT01172353|B1|Baseline|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
207827|NCT01172353|P2|Participant Flow|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
207828|NCT01172353|P1|Participant Flow|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
207829|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
207830|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
207831|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
207832|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
207833|NCT01172353|E2|Reported Event|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
225950|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
207836|NCT01172288|B2|Baseline|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207837|NCT01172288|B1|Baseline|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207838|NCT01172288|P2|Participant Flow|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207839|NCT01172288|P1|Participant Flow|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207840|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207841|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207842|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207843|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207844|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207845|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207846|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207847|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207848|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207849|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207850|NCT01172288|E2|Reported Event|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
207851|NCT01172288|E1|Reported Event|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
207852|NCT01172184|B1|Baseline|Patients With Either Chronic or Acute Mitral Regurgitation|
207853|NCT01172184|P1|Participant Flow|Patients With Either Chronic or Acute Mitral Regurgitation|
207854|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
207855|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
207856|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
207857|NCT01172184|E1|Reported Event|Patients With Either Chronic or Acute Mitral Regurgitation|
207858|NCT01172145|B3|Baseline|Total|Total of all reporting groups
207859|NCT01172145|B2|Baseline|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207860|NCT01172145|B1|Baseline|Cholinesterase Inhibitor Only|participants who received placebo
207861|NCT01172145|P2|Participant Flow|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207862|NCT01172145|P1|Participant Flow|Cholinesterase Inhibitor Only|participants who received placebo
207863|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207864|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207865|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207866|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207867|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207868|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207869|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207870|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207871|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207872|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207873|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207874|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207875|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207876|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207877|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207878|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
207879|NCT01172145|E2|Reported Event|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
207880|NCT01172145|E1|Reported Event|Cholinesterase Inhibitor Only|participants who received placebo
207881|NCT01171976|B4|Baseline|Total|Total of all reporting groups
207882|NCT01171976|B3|Baseline|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207883|NCT01171976|B2|Baseline|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207884|NCT01171976|B1|Baseline|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207885|NCT01171976|P3|Participant Flow|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207886|NCT01171976|P2|Participant Flow|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207887|NCT01171976|P1|Participant Flow|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207888|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207889|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207890|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207891|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207892|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207893|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207894|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207895|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207896|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207897|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207898|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207899|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207900|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207901|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207902|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207903|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207904|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207905|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207906|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207907|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207908|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207909|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207910|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207911|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207912|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207913|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207914|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207915|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207916|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207917|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207918|NCT01171976|E3|Reported Event|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
207919|NCT01171976|E2|Reported Event|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
207920|NCT01171976|E1|Reported Event|TE Ranibizumab 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
207921|NCT01171963|B3|Baseline|Total|Total of all reporting groups
207922|NCT01171963|B2|Baseline|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208027|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208028|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208029|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
225951|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
207923|NCT01171963|B1|Baseline|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207924|NCT01171963|P2|Participant Flow|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207925|NCT01171963|P1|Participant Flow|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207926|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207927|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207928|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207929|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208030|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208031|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208032|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208033|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208034|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208035|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
207930|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207931|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207932|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207933|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207934|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207935|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207936|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208036|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208037|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208038|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208039|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208040|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208041|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208042|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
207937|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207938|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207939|NCT01171963|O1|Outcome|Overall Study Arm|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207940|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207941|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207942|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207943|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208043|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208044|NCT01171820|E2|Reported Event|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208045|NCT01171820|E1|Reported Event|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208046|NCT01171690|B3|Baseline|Total|Total of all reporting groups
208047|NCT01171690|B2|Baseline|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
207944|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207945|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207946|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207947|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207948|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207949|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207950|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208048|NCT01171690|B1|Baseline|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
208049|NCT01171690|P2|Participant Flow|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
208050|NCT01171690|P1|Participant Flow|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
207951|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207952|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207953|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207954|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207955|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207956|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207957|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208051|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
208052|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
208275|NCT01170754|E2|Reported Event|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
207958|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207959|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207960|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207961|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207962|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207963|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207964|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208053|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
208054|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
208170|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
207965|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207966|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207967|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207968|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207969|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207970|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207971|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.Not Applicable
208055|NCT01171690|E2|Reported Event|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
208056|NCT01171690|E1|Reported Event|Teriparatide|"The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.~There were no adverse events related to the use of teriparatide."
208057|NCT01171677|B3|Baseline|Total|Total of all reporting groups
208058|NCT01171677|B2|Baseline|Treatment as Usual|
207972|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207973|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207974|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207975|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207976|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207977|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207978|NCT01171963|E2|Reported Event|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
208059|NCT01171677|B1|Baseline|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
225952|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
207979|NCT01171963|E1|Reported Event|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
207980|NCT01171924|B3|Baseline|Total|Total of all reporting groups
207981|NCT01171924|B2|Baseline|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
207982|NCT01171924|B1|Baseline|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
207983|NCT01171924|P2|Participant Flow|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
207984|NCT01171924|P1|Participant Flow|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
207985|NCT01171924|O2|Outcome|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
207986|NCT01171924|O1|Outcome|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
207987|NCT01171924|E2|Reported Event|Arm B: 3 Days/Week|
207988|NCT01171924|E1|Reported Event|Arm A: 5 Days/Week|
207989|NCT01171820|B3|Baseline|Total|Total of all reporting groups
207990|NCT01171820|B2|Baseline|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
207991|NCT01171820|B1|Baseline|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
207992|NCT01171820|P2|Participant Flow|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
207993|NCT01171820|P1|Participant Flow|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
207994|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
207995|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
207996|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
207997|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
207998|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
207999|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208000|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208001|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208002|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208003|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208004|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208005|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208006|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208007|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208008|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208009|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208010|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208011|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208012|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208013|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208014|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208015|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208016|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208017|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208018|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208019|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208020|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208021|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208022|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208023|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208024|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208025|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
208026|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
208060|NCT01171677|P2|Participant Flow|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208061|NCT01171677|P1|Participant Flow|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208062|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208063|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208064|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208065|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208066|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208067|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208068|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
225953|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
208069|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208070|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208071|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208072|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208073|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208074|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208075|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208076|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208077|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208402|NCT01170208|B3|Baseline|Group III|Type 2 diabetes treated with biphasic insulin.
225954|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
208078|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208079|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208080|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208081|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208082|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208083|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208084|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208085|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208086|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
225955|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
208087|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208088|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
208089|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208090|NCT01171677|E2|Reported Event|Treatment As Usual|
208091|NCT01171677|E1|Reported Event|Intensati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
208092|NCT01171612|B1|Baseline|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
208093|NCT01171612|P1|Participant Flow|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
208094|NCT01171612|O3|Outcome|Complete Withdrawal|patients with aspirin oand/or clopidogrel, which stopped therapy > 5 days
208095|NCT01171612|O2|Outcome|Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)|Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days
208096|NCT01171612|O1|Outcome|Not Withdrawal Antiplatelet Therapy|Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days
208097|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
208098|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
208099|NCT01171612|E1|Reported Event|Cardiac and Cerebrovascular Events|Adverse events registered independently related with antiplatelet therapy management
208100|NCT01171534|B3|Baseline|Total|Total of all reporting groups
208101|NCT01171534|B2|Baseline|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
208102|NCT01171534|B1|Baseline|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
208103|NCT01171534|P2|Participant Flow|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
208104|NCT01171534|P1|Participant Flow|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
208105|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
208106|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
208107|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
208108|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
208109|NCT01171534|E2|Reported Event|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
208110|NCT01171534|E1|Reported Event|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
208276|NCT01170754|E1|Reported Event|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208111|NCT01171521|B1|Baseline|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
208112|NCT01171521|P1|Participant Flow|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
208113|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
208114|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
208115|NCT01171521|E1|Reported Event|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
208116|NCT01171183|B3|Baseline|Total|Total of all reporting groups
208117|NCT01171183|B2|Baseline|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
208118|NCT01171183|B1|Baseline|Placebo|Placebo: Placebo
208119|NCT01171183|P2|Participant Flow|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
208120|NCT01171183|P1|Participant Flow|Placebo|Placebo: Placebo
208121|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
208122|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
208123|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
208124|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
208125|NCT01171183|E2|Reported Event|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
208126|NCT01171183|E1|Reported Event|Placebo|Placebo: Placebo
208127|NCT01171118|B1|Baseline|Physostigmine/Placebo|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this.
208128|NCT01171118|P1|Participant Flow|Physostigmine vs. Placebo in Room Air vs. O2 During Sedation|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day.~There were eight total possible sequences."
208129|NCT01171118|O4|Outcome|Placebo/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
208130|NCT01171118|O3|Outcome|Physostigmine/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
208131|NCT01171118|O2|Outcome|Placebo/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
208277|NCT01170663|B3|Baseline|Total|Total of all reporting groups
225956|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
208132|NCT01171118|O1|Outcome|Physostigmine/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
208133|NCT01171118|E4|Reported Event|Room Air|Subjects were assessed for two separate one hour periods of time -- one hour while breathing room air
208134|NCT01171118|E3|Reported Event|Oxygen|Subjects were assessed for two separate one hour periods of time -- one hour while breathing oxygen via a nasal cannula at 2 liters/minute
208135|NCT01171118|E2|Reported Event|Placebo|We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in OSA patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study is physostigmine versus placebo.
208136|NCT01171118|E1|Reported Event|Physostigmine|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application
208137|NCT01169987|B1|Baseline|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
208138|NCT01169987|P1|Participant Flow|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
208139|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208140|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208141|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208142|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208143|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208144|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208145|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208146|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208147|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208148|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208149|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208403|NCT01170208|B2|Baseline|Group II|Type 2 diabetes treated with basalbolus therapy
225957|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
208150|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208151|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208152|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208153|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208154|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208155|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208156|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208157|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208158|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208159|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208160|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208161|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208162|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208163|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208164|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208165|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208166|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208167|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208168|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208169|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208171|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208172|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208173|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208174|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208175|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208176|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208177|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208178|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208179|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208180|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208181|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208182|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208183|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208184|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208185|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208186|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208187|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208188|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208189|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208278|NCT01170663|B2|Baseline|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208404|NCT01170208|B1|Baseline|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
208190|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208191|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208192|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208193|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
208194|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
208195|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
208196|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
208197|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
208198|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
208199|NCT01169987|O1|Outcome|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
208200|NCT01169987|E1|Reported Event|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
208201|NCT01170962|B4|Baseline|Total|Total of all reporting groups
208202|NCT01170962|B3|Baseline|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208203|NCT01170962|B2|Baseline|Daclastavir (60mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208204|NCT01170962|B1|Baseline|Daclastavir (20mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208205|NCT01170962|P3|Participant Flow|Placebo: Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208405|NCT01170208|P3|Participant Flow|Group III|Type 2 diabetes treated with biphasic insulin.
208206|NCT01170962|P2|Participant Flow|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208207|NCT01170962|P1|Participant Flow|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208208|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208209|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208210|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208211|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208212|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208229|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208279|NCT01170663|B1|Baseline|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208213|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208214|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208215|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
208216|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208217|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208218|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208219|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208220|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208271|NCT01170754|P2|Participant Flow|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208272|NCT01170754|P1|Participant Flow|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208397|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208221|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208222|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208223|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208224|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208225|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208226|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208227|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208228|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208398|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208230|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208231|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208232|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208233|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208234|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208235|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208236|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208237|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208273|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208274|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208238|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208239|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208240|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208241|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208242|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208243|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208244|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208245|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208399|NCT01170221|E2|Reported Event|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208246|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208247|NCT01170962|E3|Reported Event|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208248|NCT01170962|E2|Reported Event|Daclatasvir (60 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208249|NCT01170962|E1|Reported Event|Daclatasvir (20 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
208250|NCT01170949|B3|Baseline|Total|Total of all reporting groups
208251|NCT01170949|B2|Baseline|Placebo|
208252|NCT01170949|B1|Baseline|Miltefosine|
208253|NCT01170949|P2|Participant Flow|Placebo|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
208254|NCT01170949|P1|Participant Flow|Miltefosine|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
208255|NCT01170949|O2|Outcome|Placebo|Placebo: Placebo
208256|NCT01170949|O1|Outcome|Miltefosine|Miltefosine: 50 or 100 or 150mg per day
208257|NCT01170949|E2|Reported Event|Placebo|
208258|NCT01170949|E1|Reported Event|Miltefosine|
208259|NCT01170884|B3|Baseline|Total|Total of all reporting groups
208260|NCT01170884|B2|Baseline|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
208261|NCT01170884|B1|Baseline|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
208262|NCT01170884|P2|Participant Flow|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
208263|NCT01170884|P1|Participant Flow|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
208264|NCT01170884|O2|Outcome|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
208265|NCT01170884|O1|Outcome|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
208266|NCT01170884|E2|Reported Event|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
208267|NCT01170884|E1|Reported Event|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
208268|NCT01170754|B3|Baseline|Total|Total of all reporting groups
208269|NCT01170754|B2|Baseline|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208270|NCT01170754|B1|Baseline|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
208280|NCT01170663|P2|Participant Flow|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208281|NCT01170663|P1|Participant Flow|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208282|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208283|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208284|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208285|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208286|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208287|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208288|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208289|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208290|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208291|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208292|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208293|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208294|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208295|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208296|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208297|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208298|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208299|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208300|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208301|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208302|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208303|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208304|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
208305|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208306|NCT01170663|E2|Reported Event|Placebo and Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
208307|NCT01170663|E1|Reported Event|Ramucirumab and Paclitaxel|8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
208308|NCT01170598|B1|Baseline|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208309|NCT01170598|P1|Participant Flow|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208310|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208311|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208312|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208313|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208314|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208315|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208316|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208317|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208318|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208319|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208320|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208321|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208322|NCT01170598|E1|Reported Event|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
208323|NCT01170546|B5|Baseline|Total|Total of all reporting groups
208324|NCT01170546|B4|Baseline|Control|Control group
208325|NCT01170546|B3|Baseline|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
208326|NCT01170546|B2|Baseline|SP (Squat Press)|plate-loaded squat press
208327|NCT01170546|B1|Baseline|KLCIR|plate-loaded kneeling leg curl with internal rotation
208328|NCT01170546|P4|Participant Flow|Control|Control group
208329|NCT01170546|P3|Participant Flow|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
208330|NCT01170546|P2|Participant Flow|SP (Squat Press)|plate-loaded squat press
208331|NCT01170546|P1|Participant Flow|KLCIR|plate-loaded kneeling leg curl with internal rotation
208332|NCT01170546|O4|Outcome|Control|Control group
208333|NCT01170546|O3|Outcome|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
208334|NCT01170546|O2|Outcome|SP (Squat Press)|plate-loaded squat press
208335|NCT01170546|O1|Outcome|KLCIR|plate-loaded kneeling leg curl with internal rotation
208336|NCT01170546|E4|Reported Event|Control|Control group
208337|NCT01170546|E3|Reported Event|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
208338|NCT01170546|E2|Reported Event|SP (Squat Press)|plate-loaded squat press
208339|NCT01170546|E1|Reported Event|KLCIR|plate-loaded kneeling leg curl with internal rotation
208340|NCT01170533|B1|Baseline|All Study Participants|"This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).~The PPI could be omeprazole (first phase) or pantoprazole (second phase)."
208341|NCT01170533|P2|Participant Flow|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
208342|NCT01170533|P1|Participant Flow|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
208343|NCT01170533|O6|Outcome|Clopidogrel Only (Pantoprazole Phase)|Participants took clopidogrel only
208344|NCT01170533|O5|Outcome|Clopidogrel Only (Omeprazole Phase)|Participants took clopidogrel only
208345|NCT01170533|O4|Outcome|Pantoprazole Staggered|Participants took pantoprazole with clopidogrel staggered
208346|NCT01170533|O3|Outcome|Pantoprazole Concomitant|Participants took pantoprazole with clopidogrel concomitantly
208347|NCT01170533|O2|Outcome|Omeprazole Staggered|Participants took omeprazole with clopidogrel staggered
208348|NCT01170533|O1|Outcome|Omeprazole Concomitant|Participants took omeprazole with clopidogrel concomitantly
208349|NCT01170533|E2|Reported Event|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
208350|NCT01170533|E1|Reported Event|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
208351|NCT01170390|B3|Baseline|Total|Total of all reporting groups
208352|NCT01170390|B2|Baseline|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208353|NCT01170390|B1|Baseline|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208354|NCT01170390|P3|Participant Flow|Study Arm #2 (Aviane and Portia)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208355|NCT01170390|P2|Participant Flow|Study Arm #1 (Aviane and Aviane)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208356|NCT01170390|P1|Participant Flow|All Participants|All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
208357|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208358|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208400|NCT01170221|E1|Reported Event|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208401|NCT01170208|B4|Baseline|Total|Total of all reporting groups
208359|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208360|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208361|NCT01170390|O2|Outcome|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208362|NCT01170390|O1|Outcome|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208363|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208364|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208365|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208366|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208367|NCT01170390|E2|Reported Event|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
208368|NCT01170390|E1|Reported Event|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
208369|NCT01170273|B3|Baseline|Total|Total of all reporting groups
208370|NCT01170273|B2|Baseline|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
208371|NCT01170273|B1|Baseline|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
208372|NCT01170273|P2|Participant Flow|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
208373|NCT01170273|P1|Participant Flow|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
208374|NCT01170273|O2|Outcome|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
208375|NCT01170273|O1|Outcome|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
208376|NCT01170273|E2|Reported Event|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
208377|NCT01170273|E1|Reported Event|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
208378|NCT01170221|B3|Baseline|Total|Total of all reporting groups
208379|NCT01170221|B2|Baseline|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208380|NCT01170221|B1|Baseline|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208381|NCT01170221|P2|Participant Flow|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208382|NCT01170221|P1|Participant Flow|Tedizolid Phosphate|Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208383|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208384|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208385|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208386|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208387|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208388|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208389|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208390|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208391|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208392|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208393|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208394|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208395|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
208396|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
208406|NCT01170208|P2|Participant Flow|Group II|Type 2 diabetes treated with basalbolus therapy
208407|NCT01170208|P1|Participant Flow|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
208408|NCT01170208|O3|Outcome|Group III|Type 2 diabetes treated with biphasic insulin
208409|NCT01170208|O2|Outcome|Group II|Type 2 diabetes treated with basal bolus therapy
208410|NCT01170208|O1|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin the
208411|NCT01170208|E3|Reported Event|Group III|Type 2 diabetes treated with biphasic insulin.
208412|NCT01170208|E2|Reported Event|Group II|Type 2 diabetes treated with basalbolus therapy
208413|NCT01170208|E1|Reported Event|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
208414|NCT01170091|B1|Baseline|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
208415|NCT01170091|P1|Participant Flow|Mirapex|Patients with RLS who had initiated with Mirapex
208416|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
208417|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
208418|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
208419|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
208420|NCT01170091|E1|Reported Event|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
208421|NCT01170039|B3|Baseline|Total|Total of all reporting groups
208422|NCT01170039|B2|Baseline|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208423|NCT01170039|B1|Baseline|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208424|NCT01170039|P2|Participant Flow|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208425|NCT01170039|P1|Participant Flow|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208426|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208427|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208428|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208429|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208430|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208431|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208432|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208433|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208434|NCT01170039|E2|Reported Event|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
208435|NCT01170039|E1|Reported Event|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
208436|NCT01169779|B3|Baseline|Total|Total of all reporting groups
208437|NCT01169779|B2|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
208438|NCT01169779|B1|Baseline|Placebo|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
208439|NCT01169779|P2|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
208440|NCT01169779|P1|Participant Flow|Placebo|1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
208441|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208442|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208443|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208444|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208445|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208446|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208447|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208448|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208449|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208450|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208451|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208452|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208453|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208454|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208455|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208456|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208457|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208458|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208459|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
208460|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
208461|NCT01169779|E2|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
208462|NCT01169779|E1|Reported Event|Placebo|1-step initiation regimen of volume matching placebo.
208463|NCT01169753|B3|Baseline|Total|Total of all reporting groups
209437|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
208464|NCT01169753|B2|Baseline|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
208465|NCT01169753|B1|Baseline|Placebo|Oral placebo every morning for 2 weeks.
208466|NCT01169753|P2|Participant Flow|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
208467|NCT01169753|P1|Participant Flow|Placebo|Oral placebo every morning for 2 weeks.
208468|NCT01169753|O2|Outcome|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
208469|NCT01169753|O1|Outcome|Placebo|Oral placebo every morning for 2 weeks.
208470|NCT01169753|E2|Reported Event|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
208471|NCT01169753|E1|Reported Event|Placebo|Oral placebo every morning for 2 weeks.
208472|NCT01169701|B3|Baseline|Total|Total of all reporting groups
208473|NCT01169701|B2|Baseline|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208474|NCT01169701|B1|Baseline|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208475|NCT01169701|P2|Participant Flow|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208476|NCT01169701|P1|Participant Flow|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208477|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208478|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208479|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208480|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208481|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208482|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208483|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208484|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208485|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208486|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208487|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208488|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208513|NCT01169675|P5|Participant Flow|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
208514|NCT01169675|P4|Participant Flow|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
208489|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208490|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208491|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208492|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208493|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208494|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208495|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208496|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208497|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208498|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208499|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208500|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208501|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208502|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208503|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208504|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208505|NCT01169701|E2|Reported Event|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
208506|NCT01169701|E1|Reported Event|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
208507|NCT01169675|B6|Baseline|Total|Total of all reporting groups
208508|NCT01169675|B5|Baseline|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208509|NCT01169675|B4|Baseline|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208510|NCT01169675|B3|Baseline|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208511|NCT01169675|B2|Baseline|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208512|NCT01169675|B1|Baseline|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208515|NCT01169675|P3|Participant Flow|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
208516|NCT01169675|P2|Participant Flow|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
208517|NCT01169675|P1|Participant Flow|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
208518|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208519|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208520|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208521|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208522|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208523|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208524|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208525|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208526|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208527|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208528|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208529|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208530|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208531|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208532|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208533|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208534|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208535|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208536|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208537|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208538|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208539|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208540|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208541|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208542|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208543|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208544|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208545|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208546|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208547|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208548|NCT01169675|E5|Reported Event|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
208549|NCT01169675|E4|Reported Event|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
208550|NCT01169675|E3|Reported Event|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
208551|NCT01169675|E2|Reported Event|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
208552|NCT01169675|E1|Reported Event|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
208553|NCT01169649|B1|Baseline|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
208554|NCT01169649|P1|Participant Flow|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
208555|NCT01169649|O1|Outcome|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
208556|NCT01169649|E1|Reported Event|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
208557|NCT01169610|B1|Baseline|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208558|NCT01169610|P1|Participant Flow|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208559|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208560|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208561|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208562|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208563|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208564|NCT01169610|E1|Reported Event|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
208565|NCT01169558|B1|Baseline|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208566|NCT01169558|P1|Participant Flow|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208567|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208568|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208569|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208570|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208571|NCT01169558|E1|Reported Event|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
208572|NCT01169519|B1|Baseline|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
208573|NCT01169519|P1|Participant Flow|Baseline/Sildenafil|Assessment of baseline hemodynamics followed by sildenafil infusion with repeat assessment of hemodynamics
208574|NCT01169519|O2|Outcome|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
208575|NCT01169519|O1|Outcome|Baseline|Assessment of baseline hemodynamics
208576|NCT01169519|O4|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusionplasma concentration
208577|NCT01169519|O3|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
208578|NCT01169519|O2|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
208579|NCT01169519|O1|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
208580|NCT01169519|E4|Reported Event|Dose = 0.45mg/kg|Subjects receiving a sildenafil dose of 0.45mg/kg IV over 20 min
208581|NCT01169519|E3|Reported Event|Dose = 0.35mg/kg|Subjects receiving a sildenafil dose of 0.35mg/kg IV over 20 min
208582|NCT01169519|E2|Reported Event|Dose = 0.25mg/kg|Subjects receiving a sildenafil dose of 0.25mg/kg IV over 20 min
208583|NCT01169519|E1|Reported Event|Dose = 0.125mg/kg|Subjects receiving a sildenafil dose of 0.125mg/kg IV over 20 min
208584|NCT01169493|B7|Baseline|Total|Total of all reporting groups
208585|NCT01169493|B6|Baseline|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208586|NCT01169493|B5|Baseline|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208587|NCT01169493|B4|Baseline|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208616|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208617|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208588|NCT01169493|B3|Baseline|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208589|NCT01169493|B2|Baseline|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208590|NCT01169493|B1|Baseline|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208591|NCT01169493|P6|Participant Flow|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208592|NCT01169493|P5|Participant Flow|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208593|NCT01169493|P4|Participant Flow|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208594|NCT01169493|P3|Participant Flow|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208595|NCT01169493|P2|Participant Flow|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208596|NCT01169493|P1|Participant Flow|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
208597|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208598|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208599|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208600|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208601|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208602|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208603|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208604|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208605|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208606|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208607|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208608|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208609|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208610|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208611|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208612|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208613|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208614|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208615|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208618|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
208619|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
208620|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
208621|NCT01169493|E3|Reported Event|Bi-V DDD-40|Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
208622|NCT01169493|E2|Reported Event|RV DDD-40|RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
208623|NCT01169493|E1|Reported Event|VVI-40|VVI-40: Pacing mode set to VVI-40, RV only pacing
208624|NCT01169467|B3|Baseline|Total|Total of all reporting groups
208625|NCT01169467|B2|Baseline|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208626|NCT01169467|B1|Baseline|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208627|NCT01169467|P2|Participant Flow|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208628|NCT01169467|P1|Participant Flow|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208629|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208630|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208631|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208632|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208633|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208634|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208635|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208636|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208637|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208638|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208639|NCT01169467|E2|Reported Event|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
208640|NCT01169467|E1|Reported Event|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
208641|NCT01169311|B1|Baseline|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
208642|NCT01169311|P1|Participant Flow|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
208643|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208644|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208645|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208646|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
208647|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208648|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208649|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208650|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208651|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
208652|NCT01169311|E1|Reported Event|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
208653|NCT01169103|B3|Baseline|Total|Total of all reporting groups
208654|NCT01169103|B2|Baseline|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208655|NCT01169103|B1|Baseline|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208656|NCT01169103|P2|Participant Flow|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208657|NCT01169103|P1|Participant Flow|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208658|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208659|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208660|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208661|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208662|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208663|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208664|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208665|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208666|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208667|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208668|NCT01169103|E2|Reported Event|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
208669|NCT01169103|E1|Reported Event|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
208670|NCT01169038|B1|Baseline|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
208671|NCT01169038|P1|Participant Flow|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
208672|NCT01169038|O1|Outcome|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
208673|NCT01169038|E1|Reported Event|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
208674|NCT01168999|B5|Baseline|Total|Total of all reporting groups
208675|NCT01168999|B4|Baseline|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208676|NCT01168999|B3|Baseline|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208677|NCT01168999|B2|Baseline|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208678|NCT01168999|B1|Baseline|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208679|NCT01168999|P4|Participant Flow|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208717|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208680|NCT01168999|P3|Participant Flow|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208681|NCT01168999|P2|Participant Flow|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208682|NCT01168999|P1|Participant Flow|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208683|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208684|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208685|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208686|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208687|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208688|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208689|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208690|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208691|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208692|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208693|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208694|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208695|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208696|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208697|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208698|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208699|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208700|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208701|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208702|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208703|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208704|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208705|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208706|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208707|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208708|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208709|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208710|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208711|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208712|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208713|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208714|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208715|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208716|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
225958|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
208718|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208719|NCT01168999|E4|Reported Event|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
208720|NCT01168999|E3|Reported Event|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
208721|NCT01168999|E2|Reported Event|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
208722|NCT01168999|E1|Reported Event|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
208723|NCT01168986|B4|Baseline|Total|Total of all reporting groups
208724|NCT01168986|B3|Baseline|No Intervention|Participants receive/perform no intervention
208725|NCT01168986|B2|Baseline|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208726|NCT01168986|B1|Baseline|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208727|NCT01168986|P3|Participant Flow|No Intervention|Participants receive/perform no intervention
208728|NCT01168986|P2|Participant Flow|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208729|NCT01168986|P1|Participant Flow|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208730|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
208731|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208732|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208733|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
208734|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208735|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208736|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
208737|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208738|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208739|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
208740|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208741|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208742|NCT01168986|E3|Reported Event|No Intervention|Participants receive/perform no intervention
208743|NCT01168986|E2|Reported Event|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
208744|NCT01168986|E1|Reported Event|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
208745|NCT01168973|B3|Baseline|Total|Total of all reporting groups
208746|NCT01168973|B2|Baseline|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208747|NCT01168973|B1|Baseline|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208748|NCT01168973|P2|Participant Flow|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208749|NCT01168973|P1|Participant Flow|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.~Docetaxel: 75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208750|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208751|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208752|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208753|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208754|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208755|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208756|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208757|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208758|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208759|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208760|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208761|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208762|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208763|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208764|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208765|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208868|NCT01168726|P1|Participant Flow|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208766|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208767|NCT01168973|E2|Reported Event|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208768|NCT01168973|E1|Reported Event|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
208769|NCT01168934|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
208770|NCT01168934|P2|Participant Flow|Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV|Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
208771|NCT01168934|P1|Participant Flow|Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral|Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
208772|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208773|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208774|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208775|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208776|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208777|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208778|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208779|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208780|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208781|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208782|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208783|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208784|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208785|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208786|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208787|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208788|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208789|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208790|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208791|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208792|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208793|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208794|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208795|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208796|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208797|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208798|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208799|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208800|NCT01168934|E2|Reported Event|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
208801|NCT01168934|E1|Reported Event|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
208802|NCT01168856|B3|Baseline|Total|Total of all reporting groups
208869|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208870|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
209438|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
208803|NCT01168856|B2|Baseline|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208804|NCT01168856|B1|Baseline|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208805|NCT01168856|P2|Participant Flow|Sustained Virological Response (SVR) Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208806|NCT01168856|P1|Participant Flow|Resistance Monitoring Arm|Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208807|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
208808|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208809|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208810|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208811|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208812|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208813|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
208814|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208871|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208872|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208815|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208816|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208817|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208818|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208819|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208820|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208821|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208822|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208823|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208824|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208825|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208873|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
209330|NCT01166282|B1|Baseline|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
208826|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208827|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208828|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208829|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208830|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208831|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208832|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208833|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
208834|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208835|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208874|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208875|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208876|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
209369|NCT01166178|B3|Baseline|Total|Total of all reporting groups
208836|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208837|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208838|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208839|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208840|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208841|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208842|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208843|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208844|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
209004|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208845|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208846|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208847|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208848|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208849|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208850|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208851|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208852|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208853|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
209005|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208854|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208855|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208856|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208857|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208858|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208859|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
208860|NCT01168856|E2|Reported Event|SVR Durability Monitoring Arm|Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
208861|NCT01168856|E1|Reported Event|Resistance Monitoring Arm|Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.
208862|NCT01168726|B4|Baseline|Total|Total of all reporting groups
208863|NCT01168726|B3|Baseline|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208864|NCT01168726|B2|Baseline|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
208865|NCT01168726|B1|Baseline|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208866|NCT01168726|P3|Participant Flow|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208867|NCT01168726|P2|Participant Flow|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
209037|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208877|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208878|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208879|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
208880|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208881|NCT01168726|E3|Reported Event|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
208882|NCT01168726|E2|Reported Event|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
208883|NCT01168726|E1|Reported Event|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
208884|NCT01168687|B3|Baseline|Total|Total of all reporting groups
208885|NCT01168687|B2|Baseline|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
208886|NCT01168687|B1|Baseline|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
208887|NCT01168687|P2|Participant Flow|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
208888|NCT01168687|P1|Participant Flow|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
208889|NCT01168687|O2|Outcome|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
208890|NCT01168687|O1|Outcome|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
208891|NCT01168687|E2|Reported Event|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
208892|NCT01168687|E1|Reported Event|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
208893|NCT01168674|B1|Baseline|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
208894|NCT01168674|P2|Participant Flow|Ziprasidone-washout-placebo|ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
208895|NCT01168674|P1|Participant Flow|Placebo-washout-ziprasidone|Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.
208896|NCT01168674|O1|Outcome|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
208897|NCT01168674|O2|Outcome|Ziprasidone|Subjects randomized to ziprasidone in either the initial or crossover phase.
208898|NCT01168674|O1|Outcome|Placebo|Subjects randomized to placebo in either the initial or crossover phase
208899|NCT01168674|E2|Reported Event|Ziprasidone|Active ziprasidone administered double-blind.
208900|NCT01168674|E1|Reported Event|Placebo|Placebo administered double-blind.
208901|NCT01168596|B3|Baseline|Total|Total of all reporting groups
208902|NCT01168596|B2|Baseline|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208903|NCT01168596|B1|Baseline|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208904|NCT01168596|P2|Participant Flow|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
209038|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208905|NCT01168596|P1|Participant Flow|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208906|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208907|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208908|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208909|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208910|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208911|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208912|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208913|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208914|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208915|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208916|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208917|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208918|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208919|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208920|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208921|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208922|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208923|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208924|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208925|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208926|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208927|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208928|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208929|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208930|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208931|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208932|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208933|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208934|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
209039|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208935|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208936|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208937|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208938|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208939|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208940|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208941|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208942|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208943|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208944|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208945|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208946|NCT01168596|E2|Reported Event|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
208947|NCT01168596|E1|Reported Event|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
208948|NCT01168427|B1|Baseline|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
208949|NCT01168427|P1|Participant Flow|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
208950|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
208951|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
208952|NCT01168427|E1|Reported Event|Implant Cohort|Patient with Reveal device implanted
208953|NCT01168349|B1|Baseline|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208954|NCT01168349|P1|Participant Flow|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208955|NCT01168349|O9|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208956|NCT01168349|O8|Outcome|Chronic Lymphocytic Leukemia Participants|Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208957|NCT01168349|O7|Outcome|Hodgkin's Lymphoma Participants|Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208958|NCT01168349|O6|Outcome|Non-Hodgkin's Lymphoma Participants|Non-Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208959|NCT01168349|O5|Outcome|Multiple Myeloma Participants|Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208960|NCT01168349|O4|Outcome|Ovary Cancer Participants|Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208961|NCT01168349|O3|Outcome|Colon/Rectum Cancer Participants|Colon/rectum cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208962|NCT01168349|O2|Outcome|Breast Cancer Participants|Breast cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208963|NCT01168349|O1|Outcome|Lung Cancer Participants|Lung cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208964|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208965|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208966|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208967|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208968|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208969|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208970|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208971|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208972|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208973|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208974|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208975|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208976|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208977|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208978|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208979|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208980|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208981|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209040|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209370|NCT01166178|B2|Baseline|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
208982|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208983|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208984|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208985|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208986|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208987|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208988|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208989|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208990|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208991|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208992|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208993|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208994|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208995|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208996|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208997|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
208998|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
208999|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209000|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209001|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209002|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209003|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209006|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209007|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209008|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209009|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209010|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209011|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209012|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209013|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209014|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209015|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209016|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209017|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209018|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209019|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209020|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209021|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209022|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209023|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209024|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209025|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209026|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209027|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209028|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209029|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209030|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209031|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209032|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209033|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209034|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209035|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209036|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209041|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209042|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209043|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209044|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209045|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209046|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209047|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209048|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209049|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
209050|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209051|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209052|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209053|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209054|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia [CLL], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209055|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209056|NCT01168349|E3|Reported Event|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209057|NCT01168349|E2|Reported Event|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209058|NCT01168349|E1|Reported Event|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
209059|NCT01168232|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209060|NCT01168232|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209061|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209062|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209063|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209064|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209065|NCT01168232|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
209066|NCT01168024|B3|Baseline|Total|Total of all reporting groups
209067|NCT01168024|B2|Baseline|Standard of Care|"Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
209068|NCT01168024|B1|Baseline|CINCOR™ System Treatment|"Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.~CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
209069|NCT01168024|P2|Participant Flow|Standard of Care Plus Peri-procedural Hydration|Peri-procedural hydration utilized prior to standard of care PCI.
209070|NCT01168024|P1|Participant Flow|CINCOR™ System and CCS-1|Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
209071|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
209072|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
209073|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
209074|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
209075|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
209076|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
209077|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
209078|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
209079|NCT01168024|E2|Reported Event|Control|Peri-procedure hydration
209080|NCT01168024|E1|Reported Event|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
209081|NCT01167881|B3|Baseline|Total|Total of all reporting groups
209082|NCT01167881|B2|Baseline|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209083|NCT01167881|B1|Baseline|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209084|NCT01167881|P2|Participant Flow|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209085|NCT01167881|P1|Participant Flow|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209086|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209087|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209088|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209089|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209090|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209091|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209092|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209093|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209094|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209095|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209096|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209097|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209098|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209099|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209100|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209101|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209102|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209103|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209104|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
209371|NCT01166178|B1|Baseline|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209105|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
209106|NCT01167881|E2|Reported Event|Glimepiride|Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
209107|NCT01167881|E1|Reported Event|Empa 25mg|Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
209108|NCT01167829|B1|Baseline|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
209109|NCT01167829|P1|Participant Flow|Acyline and 0ral Testosterone|Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
209110|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209111|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209112|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209113|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209114|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209115|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209116|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
209117|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
209118|NCT01167829|O1|Outcome|Acyine and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
209119|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
209120|NCT01167829|E1|Reported Event|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
209121|NCT01167608|B1|Baseline|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
209122|NCT01167608|P1|Participant Flow|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
209123|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
209124|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
209125|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
209126|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
209127|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
209128|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
209129|NCT01167608|E1|Reported Event|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
209130|NCT01167582|B3|Baseline|Total|Total of all reporting groups
209131|NCT01167582|B2|Baseline|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
209132|NCT01167582|B1|Baseline|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209133|NCT01167582|P2|Participant Flow|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
209134|NCT01167582|P1|Participant Flow|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
209135|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
209136|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209137|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
209138|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209139|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
209140|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209141|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
209174|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209142|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209143|NCT01167582|E2|Reported Event|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
209144|NCT01167582|E1|Reported Event|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
209145|NCT01167504|B1|Baseline|Saliva Sample Collection|Collection of whole mouth and parotid saliva
209146|NCT01167504|P1|Participant Flow|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
209147|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
209148|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
209149|NCT01167504|E1|Reported Event|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
209150|NCT01167452|B1|Baseline|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
209151|NCT01167452|P1|Participant Flow|Sulfamethoxazole/Trimethoprim|"2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)~Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose"
209152|NCT01167452|O2|Outcome|Trimethoprim|Results from trimethoprim analysis
209153|NCT01167452|O1|Outcome|Sulfamethoxazole|Results from sulfamethoxazole analysis
209154|NCT01167452|E1|Reported Event|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
209155|NCT01167426|B1|Baseline|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
209156|NCT01167426|P1|Participant Flow|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
209157|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
209158|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
209159|NCT01167426|E2|Reported Event|Period 2: Glatirimer Actetate|Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
209160|NCT01167426|E1|Reported Event|Period 1: Glatiramer Acetate 20 mg/1.0 mL|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).
209161|NCT01167257|B3|Baseline|Total|Total of all reporting groups
209162|NCT01167257|B2|Baseline|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
209163|NCT01167257|B1|Baseline|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209164|NCT01167257|P2|Participant Flow|Control Arm|"Normal saline 50ml in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
209165|NCT01167257|P1|Participant Flow|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209166|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209167|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209168|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
209169|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209170|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209171|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209172|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209173|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day"
209175|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209176|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209177|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209178|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
209179|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209180|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
209181|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209182|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209183|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209184|NCT01167257|E2|Reported Event|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation'~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
209185|NCT01167257|E1|Reported Event|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A'~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
209186|NCT01167192|B1|Baseline|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209187|NCT01167192|P1|Participant Flow|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209188|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209189|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209190|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209191|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209192|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209193|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209194|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209427|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209195|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209196|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209197|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209198|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209199|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209200|NCT01167192|E1|Reported Event|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
209201|NCT01167153|B3|Baseline|Total|Total of all reporting groups
209202|NCT01167153|B2|Baseline|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209203|NCT01167153|B1|Baseline|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209204|NCT01167153|P2|Participant Flow|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209205|NCT01167153|P1|Participant Flow|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209206|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209207|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209208|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209209|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209210|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209211|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209212|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209213|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209214|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209215|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209216|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209217|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209218|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209219|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209220|NCT01167153|E2|Reported Event|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209221|NCT01167153|E1|Reported Event|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
209222|NCT01167140|B1|Baseline|Group 1|
209223|NCT01167140|P1|Participant Flow|Treatment Group|
209224|NCT01167140|O1|Outcome|Treatment Group|
209225|NCT01167140|O1|Outcome|Treatment Group|
209226|NCT01167140|O1|Outcome|Treatment Group|
209227|NCT01167140|E1|Reported Event|Treatment Group|
209228|NCT01167023|B3|Baseline|Total|Total of all reporting groups
209229|NCT01167023|B2|Baseline|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209230|NCT01167023|B1|Baseline|Placebo|Participants received placebo orally, once daily for 30 days.
209231|NCT01167023|P3|Participant Flow|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209232|NCT01167023|P2|Participant Flow|Placebo|Participants received placebo orally, once daily for 30 days.
209325|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209326|NCT01166646|E2|Reported Event|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
209233|NCT01167023|P1|Participant Flow|7.5 mg Prasugrel|Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
209234|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209235|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209236|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209237|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209238|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209239|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209240|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209241|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209242|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209243|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209244|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209245|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209246|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209247|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
209248|NCT01167023|E2|Reported Event|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
209249|NCT01167023|E1|Reported Event|Placebo|Participants received placebo orally, once daily for 30 days.
209250|NCT01166997|B3|Baseline|Total|Total of all reporting groups
209251|NCT01166997|B2|Baseline|UFH + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
209252|NCT01166997|B1|Baseline|UFH (Alone)|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
209253|NCT01166997|P2|Participant Flow|Unfractionated Heparin (UFH) + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
209254|NCT01166997|P1|Participant Flow|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
209255|NCT01166997|O2|Outcome|Intravenous Unfractionated Heparin|"Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.~Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment"
209256|NCT01166997|O1|Outcome|Ultrasound Accelerated Thrombolysis|"Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.~EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus."
209257|NCT01166997|O2|Outcome|Unfractionated Heprin + EkoSonic Procedure|Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
209258|NCT01166997|O1|Outcome|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
209259|NCT01166997|E2|Reported Event|UFH + EkoSonic|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
209260|NCT01166997|E1|Reported Event|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
209261|NCT01166971|B3|Baseline|Total|Total of all reporting groups
209262|NCT01166971|B2|Baseline|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
209263|NCT01166971|B1|Baseline|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
209264|NCT01166971|P2|Participant Flow|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
209265|NCT01166971|P1|Participant Flow|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
209266|NCT01166971|O2|Outcome|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
209267|NCT01166971|O1|Outcome|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
209268|NCT01166971|E2|Reported Event|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
209269|NCT01166971|E1|Reported Event|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
209270|NCT01166958|B3|Baseline|Total|Total of all reporting groups
209271|NCT01166958|B2|Baseline|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209272|NCT01166958|B1|Baseline|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209428|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209273|NCT01166958|P2|Participant Flow|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209274|NCT01166958|P1|Participant Flow|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209275|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209276|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209277|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209278|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209279|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209280|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209281|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209282|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209283|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209284|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209285|NCT01166958|E2|Reported Event|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
209286|NCT01166958|E1|Reported Event|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
209287|NCT01166763|B1|Baseline|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209288|NCT01166763|P1|Participant Flow|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209289|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209290|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209291|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209292|NCT01166763|E1|Reported Event|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
209293|NCT01166750|B3|Baseline|Total|Total of all reporting groups
209294|NCT01166750|B2|Baseline|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
209327|NCT01166646|E1|Reported Event|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
209328|NCT01166282|B3|Baseline|Total|Total of all reporting groups
209329|NCT01166282|B2|Baseline|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209295|NCT01166750|B1|Baseline|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
209296|NCT01166750|P2|Participant Flow|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
209297|NCT01166750|P1|Participant Flow|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
209298|NCT01166750|O2|Outcome|Wait-List Control Group|
209299|NCT01166750|O1|Outcome|CD-ROM Treatment|Jointstrong
209300|NCT01166750|E2|Reported Event|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
209301|NCT01166750|E1|Reported Event|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
209302|NCT01166659|B1|Baseline|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
209303|NCT01166659|P1|Participant Flow|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
209304|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
209305|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
209306|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
209307|NCT01166659|E2|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with unit of eyes.
209308|NCT01166659|E1|Reported Event|Non-Ocular Adverse Events|At risk population for non-ocular adverse events is included with unit of subjects
209309|NCT01166646|B3|Baseline|Total|Total of all reporting groups
209310|NCT01166646|B2|Baseline|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209311|NCT01166646|B1|Baseline|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209312|NCT01166646|P2|Participant Flow|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209313|NCT01166646|P1|Participant Flow|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209314|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209315|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209316|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209317|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209318|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209319|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209320|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209321|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209322|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209323|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209324|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
209331|NCT01166282|P3|Participant Flow|Open-label Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
209332|NCT01166282|P2|Participant Flow|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209333|NCT01166282|P1|Participant Flow|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209334|NCT01166282|O3|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
209335|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209336|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209337|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209338|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209339|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209340|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209341|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209342|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209343|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209344|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209345|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209346|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209347|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209348|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209349|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209350|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209351|NCT01166282|E3|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
209352|NCT01166282|E2|Reported Event|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
209353|NCT01166282|E1|Reported Event|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
209354|NCT01166230|B3|Baseline|Total|Total of all reporting groups
209355|NCT01166230|B2|Baseline|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209356|NCT01166230|B1|Baseline|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209357|NCT01166230|P2|Participant Flow|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
209358|NCT01166230|P1|Participant Flow|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
209359|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209360|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209361|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209362|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209363|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209364|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209365|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209366|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209367|NCT01166230|E2|Reported Event|Patients With Ta/T1, Randomized to White Light Cystoscopy|
209368|NCT01166230|E1|Reported Event|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
209372|NCT01166178|P2|Participant Flow|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209373|NCT01166178|P1|Participant Flow|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209374|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209375|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209376|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209377|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209378|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209379|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209380|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209381|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209382|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209383|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209384|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209385|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209386|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209387|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209388|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209389|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209390|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209391|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209392|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209393|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209394|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209395|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209396|NCT01166178|E2|Reported Event|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
209397|NCT01166178|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
209398|NCT01166126|B1|Baseline|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209399|NCT01166126|P1|Participant Flow|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209400|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209429|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209430|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209431|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209432|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209433|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209434|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209435|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209436|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209401|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209402|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209403|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209404|NCT01166126|E1|Reported Event|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
209405|NCT01165996|B1|Baseline|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209406|NCT01165996|P1|Participant Flow|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209407|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209408|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209409|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209410|NCT01165996|E1|Reported Event|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
209411|NCT01165983|B3|Baseline|Total|Total of all reporting groups
209412|NCT01165983|B2|Baseline|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209413|NCT01165983|B1|Baseline|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209414|NCT01165983|P2|Participant Flow|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209415|NCT01165983|P1|Participant Flow|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209416|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209417|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209418|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209419|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209420|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209421|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209422|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209423|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209424|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209425|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209426|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209439|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209440|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209441|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209442|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209443|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209444|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209445|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209446|NCT01165983|O2|Outcome|T2DM Patients|
209447|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
209448|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209449|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209450|NCT01165983|O2|Outcome|T2DM Patients|
209451|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
209452|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209453|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209454|NCT01165983|O2|Outcome|T2DM Patients|
209455|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
209456|NCT01165983|E2|Reported Event|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
209457|NCT01165983|E1|Reported Event|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
209458|NCT01165840|B1|Baseline|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
209459|NCT01165840|P1|Participant Flow|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
209460|NCT01165840|O1|Outcome|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
209461|NCT01165840|E1|Reported Event|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
209462|NCT01165775|B1|Baseline|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.~Data are available for 15 of 17 participants."
209463|NCT01165775|P1|Participant Flow|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
209464|NCT01165775|O3|Outcome|Neonates With Unknown Hypoglycemia Status|Neonates with unknown hypoglycemia status from birth to hospital discharge.
209465|NCT01165775|O2|Outcome|Neonates Without Hypoglycemia|Neonates without hypoglycemia from birth to hospital discharge.
209466|NCT01165775|O1|Outcome|Neonates With Hypoglycemia|Neonates with hypoglycemia from birth to hospital discharge.
209467|NCT01165775|O2|Outcome|Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
209468|NCT01165775|O1|Outcome|Non-Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
209469|NCT01165775|E1|Reported Event|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
209470|NCT01165684|B3|Baseline|Total|Total of all reporting groups
209471|NCT01165684|B2|Baseline|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209472|NCT01165684|B1|Baseline|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209473|NCT01165684|P2|Participant Flow|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209474|NCT01165684|P1|Participant Flow|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209475|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209907|NCT01163955|P2|Participant Flow|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
209476|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209477|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209478|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209479|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209480|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209481|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209482|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209483|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209484|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209485|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209486|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209487|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209488|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209489|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209490|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209491|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209492|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209493|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209494|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209908|NCT01163955|P1|Participant Flow|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
209495|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209496|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209497|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209498|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209499|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209500|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209501|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209502|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209503|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209504|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209505|NCT01165684|E2|Reported Event|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
209506|NCT01165684|E1|Reported Event|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
209507|NCT01165554|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
209508|NCT01165554|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
209509|NCT01165554|O1|Outcome|Specificity-Normal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
209510|NCT01165554|O1|Outcome|Sensitivity-Abnormal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
209511|NCT01165554|O1|Outcome|Specificity Percentage of Normal Visual Reads|
209512|NCT01165554|O1|Outcome|Sensitivity Percentage of Abnormal Visual Reads|
209513|NCT01165554|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
209514|NCT01165541|B1|Baseline|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
209515|NCT01165541|P1|Participant Flow|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
209516|NCT01165541|O2|Outcome|Quetiapine XR Plus Mirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)"
209517|NCT01165541|O1|Outcome|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
209518|NCT01165541|E2|Reported Event|Quetiapine XR andMirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)"
209923|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209519|NCT01165541|E1|Reported Event|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
209520|NCT01165450|B1|Baseline|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209521|NCT01165450|P1|Participant Flow|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209522|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209523|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209524|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209525|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209526|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209527|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209528|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209529|NCT01165450|E1|Reported Event|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
209530|NCT01165424|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
209531|NCT01165424|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
209532|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
209533|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
209534|NCT01165424|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
209535|NCT01165320|B3|Baseline|Total|Total of all reporting groups
209536|NCT01165320|B2|Baseline|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
209537|NCT01165320|B1|Baseline|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
209538|NCT01165320|P3|Participant Flow|Participants With Esophageal Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
209539|NCT01165320|P2|Participant Flow|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
209540|NCT01165320|P1|Participant Flow|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
209924|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209541|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
209542|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
209543|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
209544|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
209545|NCT01165320|E2|Reported Event|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
209546|NCT01165320|E1|Reported Event|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
209547|NCT01165307|B3|Baseline|Total|Total of all reporting groups
209548|NCT01165307|B2|Baseline|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209549|NCT01165307|B1|Baseline|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209550|NCT01165307|P2|Participant Flow|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209551|NCT01165307|P1|Participant Flow|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209552|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209553|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209554|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209555|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209556|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209557|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209558|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
225959|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
209559|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209560|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209561|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209562|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209563|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209564|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209565|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209566|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209567|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209568|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209569|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209570|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209571|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209572|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209573|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209604|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
209574|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209575|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209576|NCT01165307|E2|Reported Event|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
209577|NCT01165307|E1|Reported Event|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
209578|NCT01165281|B3|Baseline|Total|Total of all reporting groups
209579|NCT01165281|B2|Baseline|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209580|NCT01165281|B1|Baseline|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209581|NCT01165281|P2|Participant Flow|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209582|NCT01165281|P1|Participant Flow|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209583|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209584|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209909|NCT01163955|O2|Outcome|Postural Score Sitting in a Chair After 5 Minutes|Children sat in a chair for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
209585|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209586|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209587|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209588|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209589|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209590|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209591|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209592|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209605|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209593|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209594|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209595|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209596|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209597|NCT01165281|E2|Reported Event|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209598|NCT01165281|E1|Reported Event|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
209599|NCT01165216|B3|Baseline|Total|Total of all reporting groups
209600|NCT01165216|B2|Baseline|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209601|NCT01165216|B1|Baseline|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209602|NCT01165216|P2|Participant Flow|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209603|NCT01165216|P1|Participant Flow|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209624|NCT01165138|B2|Baseline|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
225960|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
209606|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209607|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209608|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209609|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209610|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209611|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209612|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209613|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209614|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209615|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209616|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209617|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209618|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209619|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209620|NCT01165216|E2|Reported Event|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209621|NCT01165216|E1|Reported Event|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
209622|NCT01165138|B4|Baseline|Total|Total of all reporting groups
209623|NCT01165138|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209925|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209625|NCT01165138|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209626|NCT01165138|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209627|NCT01165138|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209628|NCT01165138|P2|Participant Flow|Placebo|Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209629|NCT01165138|P1|Participant Flow|Current Anti-asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) for 4 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
209630|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209631|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209632|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209633|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209634|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209635|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209636|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209637|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209638|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209639|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209640|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209641|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209642|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209643|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209644|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209645|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209646|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209647|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209648|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209649|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209650|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209651|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209652|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209653|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209654|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209655|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209656|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209657|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209658|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209659|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209660|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209661|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209662|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209663|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209664|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209665|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209666|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209667|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209668|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209669|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209670|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209671|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209672|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209673|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209674|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209675|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209676|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209677|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209678|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209679|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209680|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209681|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209682|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209683|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209684|NCT01165138|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209685|NCT01165138|E2|Reported Event|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209686|NCT01165138|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
209687|NCT01165047|B1|Baseline|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
209688|NCT01165047|P1|Participant Flow|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
209689|NCT01165047|O1|Outcome|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
209690|NCT01165047|E1|Reported Event|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
209691|NCT01165021|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209692|NCT01165021|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209693|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209694|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209695|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209696|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209697|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
209698|NCT01165021|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
225961|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
209699|NCT01164891|B1|Baseline|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209700|NCT01164891|P1|Participant Flow|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 milligrams (mg) orally two times daily (BID) from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209701|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209702|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209703|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209704|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15 participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209705|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209706|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209707|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209708|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209709|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209710|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209711|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
210268|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
209712|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209713|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209714|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209715|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209716|NCT01164891|E1|Reported Event|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
209717|NCT01164865|B3|Baseline|Total|Total of all reporting groups
209718|NCT01164865|B2|Baseline|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
209719|NCT01164865|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
209720|NCT01164865|P2|Participant Flow|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
209721|NCT01164865|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
209722|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
209723|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
209724|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
209725|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
209726|NCT01164865|E2|Reported Event|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
209727|NCT01164865|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
209728|NCT01164722|B3|Baseline|Total|Total of all reporting groups
209729|NCT01164722|B2|Baseline|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209730|NCT01164722|B1|Baseline|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209731|NCT01164722|P2|Participant Flow|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209732|NCT01164722|P1|Participant Flow|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209733|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209734|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209735|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209910|NCT01163955|O1|Outcome|Postural Score Sitting on Floor After 5 Minutes|Children sat on the floor for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
225962|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
209736|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209737|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209738|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209739|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209740|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209741|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209742|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209743|NCT01164722|E2|Reported Event|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
209744|NCT01164722|E1|Reported Event|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
209745|NCT01164644|B3|Baseline|Total|Total of all reporting groups
209746|NCT01164644|B2|Baseline|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209747|NCT01164644|B1|Baseline|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209748|NCT01164644|P2|Participant Flow|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209749|NCT01164644|P1|Participant Flow|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209750|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209751|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209752|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209753|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209754|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209755|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209756|NCT01164644|E2|Reported Event|Placebo|The subject will take twelve pills by mouth three times a day over four days.
209757|NCT01164644|E1|Reported Event|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
209758|NCT01164579|B4|Baseline|Total|Total of all reporting groups
209759|NCT01164579|B3|Baseline|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209760|NCT01164579|B2|Baseline|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209761|NCT01164579|B1|Baseline|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209911|NCT01163955|E2|Reported Event|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
209762|NCT01164579|P3|Participant Flow|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209763|NCT01164579|P2|Participant Flow|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209764|NCT01164579|P1|Participant Flow|Tofacitinib (CP-690,550) Plus Methotrexate (MTX)|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209765|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209766|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209767|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209768|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209769|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209770|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209771|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209912|NCT01163955|E1|Reported Event|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
209913|NCT01163916|B4|Baseline|Total|Total of all reporting groups
209914|NCT01163916|B3|Baseline|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209915|NCT01163916|B2|Baseline|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209772|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209773|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209774|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209775|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209776|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209777|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209778|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209779|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209780|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209781|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209916|NCT01163916|B1|Baseline|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209917|NCT01163916|P3|Participant Flow|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209918|NCT01163916|P2|Participant Flow|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209782|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209783|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209784|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209785|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209786|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209787|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209788|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209789|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209790|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209791|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209919|NCT01163916|P1|Participant Flow|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209920|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209921|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209792|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209793|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209794|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209795|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209796|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209797|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209798|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209799|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209800|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209801|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209822|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209802|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209803|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209804|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209805|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209806|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209807|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209808|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209809|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209810|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209811|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209855|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209856|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209857|NCT01164501|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209812|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209813|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209814|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209815|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209816|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209817|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209818|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209819|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209820|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209821|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209858|NCT01164501|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
209859|NCT01164501|E1|Reported Event|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209860|NCT01164475|B3|Baseline|Total|Total of all reporting groups
209922|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209823|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209824|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209825|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209826|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209827|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209828|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209829|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209830|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209831|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209832|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209901|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209902|NCT01164137|E2|Reported Event|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209833|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209834|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209835|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209836|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209837|NCT01164579|E3|Reported Event|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209838|NCT01164579|E2|Reported Event|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209839|NCT01164579|E1|Reported Event|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
209840|NCT01164501|B4|Baseline|Total|Total of all reporting groups
209841|NCT01164501|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209842|NCT01164501|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
209843|NCT01164501|B1|Baseline|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209844|NCT01164501|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209845|NCT01164501|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
209846|NCT01164501|P1|Participant Flow|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209847|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209848|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
209849|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209850|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209851|NCT01164501|O1|Outcome|Placebo|Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
209852|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
209853|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
209854|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
211532|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
209861|NCT01164475|B2|Baseline|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209862|NCT01164475|B1|Baseline|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209863|NCT01164475|P2|Participant Flow|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209864|NCT01164475|P1|Participant Flow|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209865|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209866|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209867|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209868|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209869|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209870|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209903|NCT01164137|E1|Reported Event|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209904|NCT01163955|B3|Baseline|Total|Total of all reporting groups
209905|NCT01163955|B2|Baseline|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
211728|NCT01156311|B3|Baseline|Total|Total of all reporting groups
209871|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209872|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209873|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209874|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209875|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209876|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209877|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209878|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209879|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209880|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209881|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209882|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209883|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209884|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209885|NCT01164475|E2|Reported Event|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209886|NCT01164475|E1|Reported Event|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
209887|NCT01164137|B3|Baseline|Total|Total of all reporting groups
209888|NCT01164137|B2|Baseline|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209889|NCT01164137|B1|Baseline|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209890|NCT01164137|P2|Participant Flow|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209891|NCT01164137|P1|Participant Flow|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209892|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209893|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209894|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209895|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209896|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209897|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209898|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209899|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209900|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
209906|NCT01163955|B1|Baseline|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
209926|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209927|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209928|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209929|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209930|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209931|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209932|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209933|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209934|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209935|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209936|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209937|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209938|NCT01163916|O4|Outcome|Missing|Participants for whom acceptability data were not available.
209939|NCT01163916|O3|Outcome|Need Assistance|Participants who were unable to self-inject.
209940|NCT01163916|O2|Outcome|Not Convenient|"Participants who described the acceptability of adalimumab injections as not convenient."
209941|NCT01163916|O1|Outcome|Convenient|"Participants who described the acceptability of adalimumab injections as convenient."
209942|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209943|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209944|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209945|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209946|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209947|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209948|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209949|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209950|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
209951|NCT01163916|E3|Reported Event|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
209952|NCT01163916|E2|Reported Event|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
209953|NCT01163916|E1|Reported Event|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
209954|NCT01163851|B3|Baseline|Total|Total of all reporting groups
209955|NCT01163851|B2|Baseline|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209956|NCT01163851|B1|Baseline|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209957|NCT01163851|P2|Participant Flow|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209958|NCT01163851|P1|Participant Flow|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209959|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209960|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210106|NCT01163617|O2|Outcome|Physiolis/Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
225963|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
209961|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209962|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209963|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209964|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209965|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209966|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209967|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209968|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209969|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209970|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209971|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209972|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209973|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209974|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209975|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209976|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209977|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210061|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
209978|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209979|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209980|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209981|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209982|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209983|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209984|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209985|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209986|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209987|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209988|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209989|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209990|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209991|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209992|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209993|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209994|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210107|NCT01163617|O1|Outcome|Current/Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
225964|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
209995|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209996|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209997|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209998|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
209999|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210000|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210001|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210002|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210003|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210004|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210005|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210006|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210007|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210008|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210009|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210010|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210011|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210062|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210012|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210013|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210014|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210015|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210016|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210017|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210018|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210019|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210020|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210021|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210022|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210023|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210024|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210025|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210026|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210027|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210028|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210105|NCT01163617|O3|Outcome|Current/Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
225965|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
210029|NCT01163851|E2|Reported Event|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210030|NCT01163851|E1|Reported Event|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
210031|NCT01163760|B1|Baseline|Overall|Total number of completed participants are included in baseline measurements.
210032|NCT01163760|P4|Participant Flow|Ocufilcon D First, Then Ocufilcon D|Ocufilcon D contact lenses worn for both periods.
210033|NCT01163760|P3|Participant Flow|Etafilcon A First, Then Etafilcon A|etafilcon A contact lenses worn for both periods.
210034|NCT01163760|P2|Participant Flow|Ocufilcon D First, Then Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
210035|NCT01163760|P1|Participant Flow|Etafilcon A First, Then Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
210036|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
210037|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
210038|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
210039|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
210040|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
210041|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
210042|NCT01163760|E4|Reported Event|Oculfilcon D / Ocufilcon D|ocufilcon D contact lenses worn first and second period.
210043|NCT01163760|E3|Reported Event|Etafilcon A/ Etafilcon A|etafilcon A contact lenses worn first and second period.
210044|NCT01163760|E2|Reported Event|Ocufilcon D / Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
210045|NCT01163760|E1|Reported Event|Etafilcon A/ Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
210046|NCT01163747|B3|Baseline|Total|Total of all reporting groups
210047|NCT01163747|B2|Baseline|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210048|NCT01163747|B1|Baseline|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210049|NCT01163747|P2|Participant Flow|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210050|NCT01163747|P1|Participant Flow|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210051|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210052|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210053|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210054|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210055|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210056|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210057|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210058|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210059|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210060|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
225966|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
210063|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210064|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210065|NCT01163747|E2|Reported Event|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210066|NCT01163747|E1|Reported Event|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
210067|NCT01163721|B3|Baseline|Total|Total of all reporting groups
210068|NCT01163721|B2|Baseline|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210069|NCT01163721|B1|Baseline|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210070|NCT01163721|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210071|NCT01163721|P1|Participant Flow|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210072|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210073|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210074|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210075|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210076|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210077|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210078|NCT01163721|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
210079|NCT01163721|E1|Reported Event|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
210080|NCT01163656|B3|Baseline|Total|Total of all reporting groups
210081|NCT01163656|B2|Baseline|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
210082|NCT01163656|B1|Baseline|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
210083|NCT01163656|P2|Participant Flow|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
210084|NCT01163656|P1|Participant Flow|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
210085|NCT01163656|O2|Outcome|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
210086|NCT01163656|O1|Outcome|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
210087|NCT01163656|E2|Reported Event|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
210088|NCT01163656|E1|Reported Event|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
210089|NCT01163617|B1|Baseline|All Study Participants|Includes participants from Phases A and B of the study
210090|NCT01163617|P8|Participant Flow|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
210091|NCT01163617|P7|Participant Flow|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
210092|NCT01163617|P6|Participant Flow|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
210093|NCT01163617|P5|Participant Flow|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
210094|NCT01163617|P4|Participant Flow|Physiolis Autoinjector First, Then Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
210095|NCT01163617|P3|Participant Flow|Current Autoinjector First, Then Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
210096|NCT01163617|P2|Participant Flow|Physiolis Syringe First, Then Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
210097|NCT01163617|P1|Participant Flow|Current Syringe First, Then Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
210098|NCT01163617|O2|Outcome|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C)
210099|NCT01163617|O1|Outcome|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C)
210100|NCT01163617|O2|Outcome|Physiolis Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
210101|NCT01163617|O1|Outcome|Current Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
210102|NCT01163617|O2|Outcome|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C)
210103|NCT01163617|O1|Outcome|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C)
210104|NCT01163617|O4|Outcome|Physiolis/Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
210108|NCT01163617|E8|Reported Event|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
210109|NCT01163617|E7|Reported Event|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
210110|NCT01163617|E6|Reported Event|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
210111|NCT01163617|E5|Reported Event|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
210112|NCT01163617|E4|Reported Event|Physiolis Autoinjector|Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
210113|NCT01163617|E3|Reported Event|Current Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
210114|NCT01163617|E2|Reported Event|Physiolis Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
210115|NCT01163617|E1|Reported Event|Current Syringe|Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
210116|NCT01163604|B3|Baseline|Total|Total of all reporting groups
210117|NCT01163604|B2|Baseline|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
210118|NCT01163604|B1|Baseline|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
210119|NCT01163604|P2|Participant Flow|"Aspirin and Clopidogrel Interventions Group"|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
210120|NCT01163604|P1|Participant Flow|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
210121|NCT01163604|O2|Outcome|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
210122|NCT01163604|O1|Outcome|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
210123|NCT01163604|E2|Reported Event|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
210124|NCT01163604|E1|Reported Event|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
210125|NCT01163474|B1|Baseline|Arm 1 - Evaluate Video Clinic Visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
210126|NCT01163474|P1|Participant Flow|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
210127|NCT01163474|O1|Outcome|Arm 1 - Provider Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
210128|NCT01163474|O1|Outcome|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
210129|NCT01163474|E2|Reported Event|Arm 2|Face-to-face follow up for subjects (control)
210130|NCT01163474|E1|Reported Event|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
210131|NCT01163461|B1|Baseline|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
210132|NCT01163461|P2|Participant Flow|Immediate Aphasia Therapy|14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
210133|NCT01163461|P1|Participant Flow|Delayed Aphasia Therapy|14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
210134|NCT01163461|O1|Outcome|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
210135|NCT01163461|E1|Reported Event|Single Group Open Trial|28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
210136|NCT01163318|B1|Baseline|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210137|NCT01163318|P1|Participant Flow|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210138|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210139|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210140|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210141|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210142|NCT01163318|E1|Reported Event|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
210143|NCT01163292|B3|Baseline|Total|Total of all reporting groups
210144|NCT01163292|B2|Baseline|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210145|NCT01163292|B1|Baseline|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210146|NCT01163292|P2|Participant Flow|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210147|NCT01163292|P1|Participant Flow|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210148|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210149|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210150|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210151|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210152|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210153|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210154|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210155|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210156|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210157|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210158|NCT01163292|E2|Reported Event|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
210159|NCT01163292|E1|Reported Event|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
210160|NCT01163279|B3|Baseline|Total|Total of all reporting groups
210161|NCT01163279|B2|Baseline|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
210162|NCT01163279|B1|Baseline|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210163|NCT01163279|P2|Participant Flow|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210164|NCT01163279|P1|Participant Flow|Cogntive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210165|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210166|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210196|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210167|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210168|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210169|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210170|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210171|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210172|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210173|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210174|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210175|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210176|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210177|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210178|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210197|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210198|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210179|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210180|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210181|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210182|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210183|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
210184|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210185|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
210186|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210187|NCT01163279|E2|Reported Event|Psychosocial Education|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210188|NCT01163279|E1|Reported Event|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
210189|NCT01163266|B4|Baseline|Total|Total of all reporting groups
210190|NCT01163266|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210191|NCT01163266|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210192|NCT01163266|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210193|NCT01163266|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210194|NCT01163266|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210195|NCT01163266|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210266|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210199|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210200|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210201|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210202|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210203|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210204|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210205|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210206|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210207|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210208|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210209|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210210|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210211|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210212|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210213|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210214|NCT01163266|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
210215|NCT01163266|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
210216|NCT01163266|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
210217|NCT01163214|B3|Baseline|Total|Total of all reporting groups
210218|NCT01163214|B2|Baseline|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210219|NCT01163214|B1|Baseline|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210220|NCT01163214|P2|Participant Flow|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210221|NCT01163214|P1|Participant Flow|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210222|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210223|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210224|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210225|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210226|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210227|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210228|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210229|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210267|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
225967|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
210230|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210231|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210232|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210233|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210234|NCT01163214|E2|Reported Event|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
210235|NCT01163214|E1|Reported Event|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
210236|NCT01163162|B1|Baseline|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210237|NCT01163162|P1|Participant Flow|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210238|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210239|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210240|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210241|NCT01163162|E1|Reported Event|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
210242|NCT01163097|B4|Baseline|Total|Total of all reporting groups
210243|NCT01163097|B3|Baseline|Untreated Control|Treatment C: control group without any treatment administered
210244|NCT01163097|B2|Baseline|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210245|NCT01163097|B1|Baseline|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210246|NCT01163097|P3|Participant Flow|Untreated Control|Treatment C: control group without any treatment administered
210247|NCT01163097|P2|Participant Flow|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210248|NCT01163097|P1|Participant Flow|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210249|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210250|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210251|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210252|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210253|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210254|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210255|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210256|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210257|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210258|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210259|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210260|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210261|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210262|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210263|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210264|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210265|NCT01163097|O3|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210269|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210270|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210271|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210272|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210273|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210274|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210275|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210276|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210277|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210278|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210279|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210280|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210281|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210282|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210283|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210284|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
210285|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210286|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210287|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210288|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210289|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210290|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210291|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210292|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210293|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210294|NCT01163097|E3|Reported Event|Untreated Control|Treatment C: control group without any treatment administered
210295|NCT01163097|E2|Reported Event|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
210296|NCT01163097|E1|Reported Event|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
210297|NCT01163032|B4|Baseline|Total|Total of all reporting groups
210298|NCT01163032|B3|Baseline|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210299|NCT01163032|B2|Baseline|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210300|NCT01163032|B1|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210301|NCT01163032|P3|Participant Flow|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210302|NCT01163032|P2|Participant Flow|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210303|NCT01163032|P1|Participant Flow|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210304|NCT01163032|O1|Outcome|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210305|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210306|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210307|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210308|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210309|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210310|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210311|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210312|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210520|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210313|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210314|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210315|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210316|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210317|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210318|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210319|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210320|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210321|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210322|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210323|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210324|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210325|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210326|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210327|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210328|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210329|NCT01163032|E3|Reported Event|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210330|NCT01163032|E2|Reported Event|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
210331|NCT01163032|E1|Reported Event|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
210332|NCT01162863|B4|Baseline|Total|Total of all reporting groups
210333|NCT01162863|B3|Baseline|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210334|NCT01162863|B2|Baseline|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210335|NCT01162863|B1|Baseline|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210336|NCT01162863|P3|Participant Flow|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210337|NCT01162863|P2|Participant Flow|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210338|NCT01162863|P1|Participant Flow|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210339|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210340|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210341|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210342|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210402|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
212551|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
210343|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210344|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210345|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210346|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210347|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210348|NCT01162863|E3|Reported Event|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210349|NCT01162863|E2|Reported Event|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210350|NCT01162863|E1|Reported Event|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
210351|NCT01162733|B3|Baseline|Total|Total of all reporting groups
210352|NCT01162733|B2|Baseline|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
210353|NCT01162733|B1|Baseline|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
210354|NCT01162733|P2|Participant Flow|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
210355|NCT01162733|P1|Participant Flow|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
210356|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
210357|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
210358|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
210359|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
210360|NCT01162733|E2|Reported Event|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
210361|NCT01162733|E1|Reported Event|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
210362|NCT01162499|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
210363|NCT01162499|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The next day, all procedures were repeated except subjects received an IV infusion of Exendin-(9-39) which was started 1 hour prior to the meal challenge and continued for 4 hours. The dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects.
210364|NCT01162499|P1|Participant Flow|Exendin-(9-39) First, Then Vehicle|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects. The next day, all procedures were repeated except subjects received an IV infusion of normal saline (vehicle) over 4 hours.
210365|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210366|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210403|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
225968|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
210367|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210368|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210369|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210370|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210371|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210372|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210373|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210374|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210375|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210376|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210377|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210378|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210404|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210519|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210379|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210380|NCT01162499|E3|Reported Event|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
210381|NCT01162499|E2|Reported Event|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
210382|NCT01162499|E1|Reported Event|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
210383|NCT01162473|B3|Baseline|Total|Total of all reporting groups
210384|NCT01162473|B2|Baseline|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
210385|NCT01162473|B1|Baseline|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
210386|NCT01162473|P2|Participant Flow|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
210387|NCT01162473|P1|Participant Flow|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
210388|NCT01162473|O2|Outcome|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
210389|NCT01162473|O1|Outcome|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
210390|NCT01162473|E2|Reported Event|Immediate Desensitization|Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
210391|NCT01162473|E1|Reported Event|Delayed Desensitization|Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).
210392|NCT01162421|B3|Baseline|Total|Total of all reporting groups
210393|NCT01162421|B2|Baseline|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210394|NCT01162421|B1|Baseline|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210395|NCT01162421|P2|Participant Flow|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210396|NCT01162421|P1|Participant Flow|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210397|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210398|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210399|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210400|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210401|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
212552|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
210405|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210406|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210407|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210408|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210409|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210410|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210411|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210412|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210413|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210414|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210415|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210416|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210417|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210418|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210419|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210420|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210421|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210422|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210423|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210424|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210425|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210426|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210427|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210428|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210429|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210430|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210431|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210432|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210433|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210434|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210435|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210436|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210437|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210438|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210439|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210440|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210441|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210442|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210443|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210444|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210445|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210446|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210447|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210448|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210449|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210450|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210451|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210452|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210453|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210454|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210455|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210456|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210457|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210458|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210459|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210460|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210461|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210462|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210463|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210464|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210465|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210466|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210467|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210468|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210469|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210470|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210471|NCT01162421|E2|Reported Event|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
210472|NCT01162421|E1|Reported Event|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
210473|NCT01162304|B1|Baseline|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210474|NCT01162304|P1|Participant Flow|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210475|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210476|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210477|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210478|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210479|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210480|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210481|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210482|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210483|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210484|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210485|NCT01162304|E2|Reported Event|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
210486|NCT01162304|E1|Reported Event|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
210487|NCT01162135|B1|Baseline|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
210488|NCT01162135|P1|Participant Flow|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
210489|NCT01162135|O1|Outcome|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
210490|NCT01162135|E1|Reported Event|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
210491|NCT01162122|B3|Baseline|Total|Total of all reporting groups
210492|NCT01162122|B2|Baseline|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210493|NCT01162122|B1|Baseline|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210494|NCT01162122|P2|Participant Flow|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210495|NCT01162122|P1|Participant Flow|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210496|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210497|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210498|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210499|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210500|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210501|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210502|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210503|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210504|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210505|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210506|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210507|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210508|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210509|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210510|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210511|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210512|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210513|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210514|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210515|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210516|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210517|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210518|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
212553|NCT01154985|E3|Reported Event|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
210521|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210522|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210523|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210524|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210525|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210526|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210527|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210528|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210529|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210530|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210531|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210532|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210533|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210534|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210535|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210536|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210537|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210538|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210539|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210540|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210541|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210542|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210543|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210544|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210545|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210546|NCT01162122|O3|Outcome|aTIV_Lot 3|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
210547|NCT01162122|O2|Outcome|aTIV_Lot 2|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
210548|NCT01162122|O1|Outcome|aTIV_Lot 1|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
210549|NCT01162122|E2|Reported Event|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
210550|NCT01162122|E1|Reported Event|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
210551|NCT01162096|B1|Baseline|Transplantation|
210552|NCT01162096|P1|Participant Flow|Transplantation|
210553|NCT01162096|O1|Outcome|Transplantation|
210554|NCT01162096|E1|Reported Event|Transplantation|
210555|NCT01161771|B1|Baseline|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210556|NCT01161771|P1|Participant Flow|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210557|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210558|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210559|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210560|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210561|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210562|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
212554|NCT01154985|E2|Reported Event|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
210563|NCT01161771|E1|Reported Event|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
210564|NCT01161628|B1|Baseline|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210565|NCT01161628|P1|Participant Flow|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210566|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210567|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210568|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210569|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210570|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210571|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210572|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210573|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210574|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210575|NCT01161628|E1|Reported Event|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
210576|NCT01161563|B3|Baseline|Total|Total of all reporting groups
210577|NCT01161563|B2|Baseline|Triptorelin First, Then Leuprolide Acetate|Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
210578|NCT01161563|B1|Baseline|Leuprolide Acetate First, Then Triptorelin|Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
210579|NCT01161563|P2|Participant Flow|Leuprolide Acetate First, Then Triptorelin|"Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.~A detailed breakdown of participant flow by treatment period for each arm is not available."
210580|NCT01161563|P1|Participant Flow|Triptorelin First, Then Leuprolide Acetate|"Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.~A detailed breakdown of participant flow by treatment period for each arm is not available."
210581|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
210582|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
210583|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
210584|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
210585|NCT01161563|E2|Reported Event|Triptorelin Pamoate|
210586|NCT01161563|E1|Reported Event|Leuprolide Acetate|
210587|NCT01161537|B1|Baseline|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210588|NCT01161537|P1|Participant Flow|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210625|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210589|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210590|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210591|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210592|NCT01161537|O1|Outcome|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
210593|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210594|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210595|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210596|NCT01161537|O2|Outcome|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
210597|NCT01161537|O1|Outcome|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
210598|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210599|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
210600|NCT01161537|E3|Reported Event|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
210601|NCT01161537|E2|Reported Event|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
210602|NCT01161537|E1|Reported Event|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
210603|NCT01161498|B3|Baseline|Total|Total of all reporting groups
210604|NCT01161498|B2|Baseline|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210605|NCT01161498|B1|Baseline|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210641|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
225969|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
210606|NCT01161498|P2|Participant Flow|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210607|NCT01161498|P1|Participant Flow|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210608|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210609|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210610|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210611|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210612|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210613|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210614|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210615|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210616|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210617|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210618|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210619|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210620|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210621|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210622|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210623|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210624|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210626|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210627|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210628|NCT01161498|E2|Reported Event|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
210629|NCT01161498|E1|Reported Event|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
210630|NCT01161472|B1|Baseline|Entire Study Population|All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).
210631|NCT01161472|P4|Participant Flow|Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
210632|NCT01161472|P3|Participant Flow|Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
210633|NCT01161472|P2|Participant Flow|Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
210634|NCT01161472|P1|Participant Flow|Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg|Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
210635|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210636|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210637|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210638|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210639|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210640|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210642|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210643|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210644|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210645|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210646|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210647|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210648|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210649|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210650|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210651|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210652|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210653|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210654|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210655|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210656|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210657|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210658|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210659|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210660|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210661|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210662|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210663|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210664|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210665|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210666|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210667|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210668|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210669|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210670|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210817|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210671|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210672|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210673|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210674|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210675|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210676|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210677|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210678|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210679|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210680|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210681|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210682|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210683|NCT01161472|E4|Reported Event|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210684|NCT01161472|E3|Reported Event|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210685|NCT01161472|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210686|NCT01161472|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
210687|NCT01161420|B1|Baseline|Inspire Therapy|"Study subjects continue to use Inspire therapy~Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration."
210688|NCT01161420|P1|Participant Flow|Inspire Therapy|126 subjects were implanted with Inspire therapy
210689|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
210690|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
210691|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
210692|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects implanted with Inspire therapy
210693|NCT01161420|O2|Outcome|Withdrawal|Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
210694|NCT01161420|O1|Outcome|Maintenance|Twenty-three (23) patients were in the therapy maintenance (ON) group
210695|NCT01161420|O1|Outcome|All Subjects|126 implanted study subjects
210696|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
210697|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
210698|NCT01161420|E1|Reported Event|Inspire Therapy|This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
210699|NCT01161407|B3|Baseline|Total|Total of all reporting groups
210762|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
210700|NCT01161407|B2|Baseline|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
210701|NCT01161407|B1|Baseline|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
210702|NCT01161407|P2|Participant Flow|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
210703|NCT01161407|P1|Participant Flow|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
210704|NCT01161407|O2|Outcome|Calcium|
210705|NCT01161407|O1|Outcome|Placebo|
210706|NCT01161407|O2|Outcome|Calcium|
210707|NCT01161407|O1|Outcome|Placebo|
210708|NCT01161407|O2|Outcome|Calcium|
210709|NCT01161407|O1|Outcome|Placebo|
210710|NCT01161407|E2|Reported Event|Calcium|
210711|NCT01161407|E1|Reported Event|Placebo|
210712|NCT01161329|B3|Baseline|Total|Total of all reporting groups
210713|NCT01161329|B2|Baseline|Intervention Group|High Intensity Functional Exercise Program
210714|NCT01161329|B1|Baseline|Controlgroup|Ordinary life.
210715|NCT01161329|P2|Participant Flow|Intervention Group|High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
210716|NCT01161329|P1|Participant Flow|Controlgroup|Instructed to live their ordinary life.
210717|NCT01161329|O2|Outcome|Group Exercise Program|High-Intensity Functional Exercise Program
210718|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
210719|NCT01161329|O2|Outcome|Intervention Group|High Intensity Functional Exercise Program
210720|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
210721|NCT01161329|E2|Reported Event|Intervention Group|High Intensity Functional Exercise Program
210722|NCT01161329|E1|Reported Event|Controlgroup|Ordinary life.
210723|NCT01161225|B4|Baseline|Total|Total of all reporting groups
210724|NCT01161225|B3|Baseline|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210725|NCT01161225|B2|Baseline|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210726|NCT01161225|B1|Baseline|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210727|NCT01161225|P3|Participant Flow|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210728|NCT01161225|P2|Participant Flow|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210729|NCT01161225|P1|Participant Flow|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210730|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210763|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
225970|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
210731|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210732|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210733|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders
210734|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program
210735|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program.
210736|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210737|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210738|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210739|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210740|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210741|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210742|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210743|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210744|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210745|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210764|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
210977|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
210746|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210747|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210748|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210749|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210750|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months
210751|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210752|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210753|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210754|NCT01161225|E3|Reported Event|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210755|NCT01161225|E2|Reported Event|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210756|NCT01161225|E1|Reported Event|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
210757|NCT01161173|B1|Baseline|Cohort|Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
210758|NCT01161173|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
210759|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
210760|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
210761|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
225971|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
210765|NCT01161173|E1|Reported Event|Erlotinib|"Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.~Erlotinib: Erlotinib was provided in the retail versions of the product."
210766|NCT01160848|B3|Baseline|Total|Total of all reporting groups
210767|NCT01160848|B2|Baseline|3 Areas Per Patient, 24 Hours|
210768|NCT01160848|B1|Baseline|3 Areas Per Patient, 3 Hours|
210769|NCT01160848|P2|Participant Flow|3 Areas Per Patient, 24 Hours|Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
210770|NCT01160848|P1|Participant Flow|3 Areas Per Patient, 3 Hours|Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
210771|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
210772|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
210773|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
210774|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
210775|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
210776|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
210777|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
210778|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
210779|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
210780|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
210781|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
210782|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
210783|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
210784|NCT01160848|O2|Outcome|Area Cleaned With Saline|
210785|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
210786|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
210787|NCT01160848|O2|Outcome|Area Cleaned With Saline|
210788|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
210789|NCT01160848|E2|Reported Event|3 Areas Per Patient, 24 Hours|
210790|NCT01160848|E1|Reported Event|3 Areas Per Patient, 3 Hours|
210791|NCT01160822|B8|Baseline|Total|Total of all reporting groups
210792|NCT01160822|B7|Baseline|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210793|NCT01160822|B6|Baseline|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210794|NCT01160822|B5|Baseline|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210795|NCT01160822|B4|Baseline|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
210796|NCT01160822|B3|Baseline|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210797|NCT01160822|B2|Baseline|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210798|NCT01160822|B1|Baseline|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210799|NCT01160822|P7|Participant Flow|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210800|NCT01160822|P6|Participant Flow|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210801|NCT01160822|P5|Participant Flow|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210802|NCT01160822|P4|Participant Flow|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
210803|NCT01160822|P3|Participant Flow|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210804|NCT01160822|P2|Participant Flow|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210805|NCT01160822|P1|Participant Flow|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210806|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210807|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210808|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210809|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210810|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210811|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210812|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210813|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210814|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210815|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210816|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210818|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210819|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210820|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210821|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210822|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210823|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210824|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210825|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210826|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210827|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210828|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210829|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210830|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210831|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210832|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210833|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210834|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210835|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210836|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210837|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210838|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210839|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210840|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210841|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210842|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210843|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210844|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210845|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210846|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210847|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210848|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210849|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210850|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210851|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210852|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210853|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210854|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
212555|NCT01154985|E1|Reported Event|Placebo|Placebo: Placebo three times a day (TID) for 365 days
210855|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210856|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210857|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210858|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210859|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210860|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210861|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210862|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210863|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210864|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210865|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210866|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210867|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210868|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210869|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210870|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210871|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210872|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210873|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210874|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210875|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210876|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210877|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210878|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210879|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210880|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210881|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210882|NCT01160822|O4|Outcome|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
210883|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210884|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210885|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210886|NCT01160822|E7|Reported Event|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
210887|NCT01160822|E6|Reported Event|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210888|NCT01160822|E5|Reported Event|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
210889|NCT01160822|E4|Reported Event|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
210890|NCT01160822|E3|Reported Event|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
210891|NCT01160822|E2|Reported Event|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
210892|NCT01160822|E1|Reported Event|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
210893|NCT01160770|B1|Baseline|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210894|NCT01160770|P1|Participant Flow|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210895|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210896|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210897|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210898|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210899|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210900|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210901|NCT01160770|E1|Reported Event|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
210902|NCT01160744|B5|Baseline|Total|Total of all reporting groups
210903|NCT01160744|B4|Baseline|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210904|NCT01160744|B3|Baseline|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210905|NCT01160744|B2|Baseline|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210906|NCT01160744|B1|Baseline|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210907|NCT01160744|P4|Participant Flow|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of each every 21-day cycle. Participants were treated for up to 89 weeks.
210908|NCT01160744|P3|Participant Flow|Gem + Carb or Cis (Squamous)|"Gemcitabine (Gem): 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb [Area Under the Concentration Time Curve 5 (AUC 5)]: Day 1 of every 21-day cycle.~Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
210909|NCT01160744|P2|Participant Flow|Ram + Pem + Carb or Cis (Non-Squamous)|Ramucirumab (Ram): 10 milligrams/kilogram (mg/kg) Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210910|NCT01160744|P1|Participant Flow|Pem + Carb or Cis (Non-Squamous)|"Pemetrexed (Pem): 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle.~Carboplatin (Carb) [Area Under the Concentration Time Curve 6 (AUC 6)] : Day 1 of every 21-day cycle.~Cisplatin (Cis): 75 mg/m² intravenous (IV) on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
210911|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210912|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210913|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
210914|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210915|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210916|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210917|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
210918|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210919|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210920|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
212556|NCT01154673|B3|Baseline|Total|Total of all reporting groups
210921|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210922|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210923|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210924|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210925|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210926|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210927|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210928|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210929|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210930|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210931|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210932|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210933|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210934|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210935|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210936|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210937|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210938|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210939|NCT01160744|E4|Reported Event|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210940|NCT01160744|E3|Reported Event|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210941|NCT01160744|E2|Reported Event|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210942|NCT01160744|E1|Reported Event|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
210943|NCT01160640|B3|Baseline|Total|Total of all reporting groups
210944|NCT01160640|B2|Baseline|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210945|NCT01160640|B1|Baseline|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210946|NCT01160640|P2|Participant Flow|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210947|NCT01160640|P1|Participant Flow|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210948|NCT01160640|O2|Outcome|Histological Endometritis Absent|Women who did not have endometritis confirmed by histologic assessment for endometritis
210949|NCT01160640|O1|Outcome|Histological Endometritis Present|Women who had endometritis confirmed by histologic assessment for endometritis. Endometritis was defined as >1 plasma cell per 100X microscopic field, was assessed independently by 2 pathologists blinded to the design
210950|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210951|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210952|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210953|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210954|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210955|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210956|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210957|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210958|NCT01160640|E2|Reported Event|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
210959|NCT01160640|E1|Reported Event|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
210960|NCT01160614|B3|Baseline|Total|Total of all reporting groups
210961|NCT01160614|B2|Baseline|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210962|NCT01160614|B1|Baseline|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210963|NCT01160614|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210964|NCT01160614|P1|Participant Flow|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210965|NCT01160614|O2|Outcome|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210966|NCT01160614|O1|Outcome|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
210967|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210968|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
210969|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
210970|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
210971|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
210972|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
210973|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210974|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
210975|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
210976|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
210978|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
210979|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210980|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
210981|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
210982|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
210983|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
210984|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
210985|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210986|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
210987|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
210988|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
210989|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
210990|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
210991|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210992|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
210993|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
210994|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
210995|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
210996|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
210997|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
210998|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
210999|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
211000|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received multiple doses of 20 mg ORF
211001|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received multiple doses of 15 mg ORF
211002|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received multiple doses of 10 mg ORF
211003|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
211004|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
211005|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
211006|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
211007|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
211008|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
211009|NCT01160614|E2|Reported Event|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
211010|NCT01160614|E1|Reported Event|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
211011|NCT01160484|B1|Baseline|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
211012|NCT01160484|P1|Participant Flow|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
211030|NCT01160445|P1|Participant Flow|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211031|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211013|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211014|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211015|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211016|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211017|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211018|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211019|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211020|NCT01160484|E1|Reported Event|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
211021|NCT01160458|B1|Baseline|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
211022|NCT01160458|P1|Participant Flow|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
211023|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
211024|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
211025|NCT01160458|E1|Reported Event|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
211026|NCT01160445|B3|Baseline|Total|Total of all reporting groups
211027|NCT01160445|B2|Baseline|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211028|NCT01160445|B1|Baseline|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211029|NCT01160445|P2|Participant Flow|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211032|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211033|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211034|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211035|NCT01160445|E2|Reported Event|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211036|NCT01160445|E1|Reported Event|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
211037|NCT01160380|B3|Baseline|Total|Total of all reporting groups
211038|NCT01160380|B2|Baseline|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.~Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets."
211039|NCT01160380|B1|Baseline|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets."
211040|NCT01160380|P2|Participant Flow|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211041|NCT01160380|P1|Participant Flow|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211042|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211043|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211044|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211045|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211046|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211047|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211048|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211049|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211050|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211051|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211052|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211053|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211054|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
211055|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
211056|NCT01160380|E2|Reported Event|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.~AEs presented were those occurring during from Day 1 to Day 28 only"
211057|NCT01160380|E1|Reported Event|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs)."
211058|NCT01160237|B4|Baseline|Total|Total of all reporting groups
211059|NCT01160237|B3|Baseline|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211060|NCT01160237|B2|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211061|NCT01160237|B1|Baseline|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211062|NCT01160237|P3|Participant Flow|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211063|NCT01160237|P2|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211064|NCT01160237|P1|Participant Flow|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211065|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
225972|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
211066|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211067|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211068|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211069|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211070|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211071|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211072|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211073|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211074|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211075|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211076|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211077|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211078|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211079|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211080|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211081|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211082|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211083|NCT01160237|E3|Reported Event|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
211084|NCT01160237|E2|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
211085|NCT01160237|E1|Reported Event|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
211086|NCT01159938|B4|Baseline|Total|Total of all reporting groups
211087|NCT01159938|B3|Baseline|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
211088|NCT01159938|B2|Baseline|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
211089|NCT01159938|B1|Baseline|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211090|NCT01159938|P5|Participant Flow|T2DM With Normal UAER, Low to High|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211091|NCT01159938|P4|Participant Flow|T2DM With Normal UAER, High to Low|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211092|NCT01159938|P3|Participant Flow|T2DM With Albuminuria, Low to High|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211093|NCT01159938|P2|Participant Flow|T2DM With Albuminuria, High to Low|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211094|NCT01159938|P1|Participant Flow|Healthy Participants|Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211095|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211096|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211097|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211098|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211099|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211100|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211101|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211102|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211103|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211104|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams albumin per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211105|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose
211106|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211107|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211108|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211109|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211110|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211111|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211112|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211113|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211114|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211115|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211116|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211117|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211118|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211119|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211120|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211121|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211122|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211123|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211124|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211125|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211126|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211127|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211128|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211129|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211147|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211130|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211131|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211132|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211133|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211134|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211135|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211136|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211137|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211138|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211139|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211140|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211141|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211142|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211143|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211144|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211145|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
211146|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
213358|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
211148|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
211149|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211150|NCT01159938|E3|Reported Event|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
211151|NCT01159938|E2|Reported Event|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
211152|NCT01159938|E1|Reported Event|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
211153|NCT01159912|B4|Baseline|Total|Total of all reporting groups
211154|NCT01159912|B3|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211155|NCT01159912|B2|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211156|NCT01159912|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211157|NCT01159912|P3|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211158|NCT01159912|P2|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211159|NCT01159912|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211160|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211161|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211162|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211163|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211164|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211165|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211166|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211167|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211168|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211169|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211170|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211171|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211172|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211173|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211174|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211175|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211176|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211177|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211178|NCT01159912|E3|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211179|NCT01159912|E2|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211180|NCT01159912|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
211181|NCT01159769|B1|Baseline|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
211182|NCT01159769|P1|Participant Flow|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
211183|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
211184|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
211185|NCT01159769|E1|Reported Event|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
211186|NCT01159743|B3|Baseline|Total|Total of all reporting groups
211187|NCT01159743|B2|Baseline|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211188|NCT01159743|B1|Baseline|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211189|NCT01159743|P2|Participant Flow|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211190|NCT01159743|P1|Participant Flow|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211191|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
225973|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
211192|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211193|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211194|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211195|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211196|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211197|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211198|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211199|NCT01159743|E2|Reported Event|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211200|NCT01159743|E1|Reported Event|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
211201|NCT01159691|B1|Baseline|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211202|NCT01159691|P1|Participant Flow|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211203|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211204|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211205|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211206|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211207|NCT01159691|E1|Reported Event|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
211208|NCT01159665|B7|Baseline|Total|Total of all reporting groups
211209|NCT01159665|B6|Baseline|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
211210|NCT01159665|B5|Baseline|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
211211|NCT01159665|B4|Baseline|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
211212|NCT01159665|B3|Baseline|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
211213|NCT01159665|B2|Baseline|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
211214|NCT01159665|B1|Baseline|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
211215|NCT01159665|P6|Participant Flow|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
211216|NCT01159665|P5|Participant Flow|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
211217|NCT01159665|P4|Participant Flow|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
211218|NCT01159665|P3|Participant Flow|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
211219|NCT01159665|P2|Participant Flow|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
211220|NCT01159665|P1|Participant Flow|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
211221|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
211222|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
211223|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
211224|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
211225|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
211226|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
211227|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
211228|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
225974|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
211229|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
211230|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
211231|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
211232|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
211233|NCT01159665|E6|Reported Event|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
211234|NCT01159665|E5|Reported Event|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
211235|NCT01159665|E4|Reported Event|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
211236|NCT01159665|E3|Reported Event|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
211237|NCT01159665|E2|Reported Event|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
211238|NCT01159665|E1|Reported Event|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
211239|NCT01159600|B9|Baseline|Total|Total of all reporting groups
211240|NCT01159600|B8|Baseline|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211241|NCT01159600|B7|Baseline|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211242|NCT01159600|B6|Baseline|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211243|NCT01159600|B5|Baseline|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211244|NCT01159600|B4|Baseline|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211245|NCT01159600|B3|Baseline|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211246|NCT01159600|B2|Baseline|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211247|NCT01159600|B1|Baseline|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211248|NCT01159600|P8|Participant Flow|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211249|NCT01159600|P7|Participant Flow|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211250|NCT01159600|P6|Participant Flow|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211251|NCT01159600|P5|Participant Flow|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211252|NCT01159600|P4|Participant Flow|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211253|NCT01159600|P3|Participant Flow|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211254|NCT01159600|P2|Participant Flow|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211255|NCT01159600|P1|Participant Flow|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211256|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211257|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211258|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211259|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211260|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211261|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211262|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211263|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211264|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211265|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
225975|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
211266|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211267|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211268|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211269|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211270|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211271|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
211272|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211273|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211274|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211275|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211276|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211277|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211278|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211279|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211280|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211281|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211282|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211283|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211284|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211285|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211286|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211287|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211288|NCT01159600|E8|Reported Event|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211289|NCT01159600|E7|Reported Event|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211290|NCT01159600|E6|Reported Event|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211291|NCT01159600|E5|Reported Event|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
211292|NCT01159600|E4|Reported Event|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211293|NCT01159600|E3|Reported Event|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
211294|NCT01159600|E2|Reported Event|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
211295|NCT01159600|E1|Reported Event|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
211296|NCT01159535|B4|Baseline|Total|Total of all reporting groups
211297|NCT01159535|B3|Baseline|Treatment as Usual|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
211329|NCT01159262|B3|Baseline|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
225976|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
211298|NCT01159535|B2|Baseline|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
211299|NCT01159535|B1|Baseline|Mindfulness Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
211300|NCT01159535|P3|Participant Flow|Treatment as Usual (TAU)|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
211301|NCT01159535|P2|Participant Flow|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
211302|NCT01159535|P1|Participant Flow|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
211303|NCT01159535|O3|Outcome|Treatment as Usual (TAU)|Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
211304|NCT01159535|O2|Outcome|Relapse Prevention (RP)|The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
211305|NCT01159535|O1|Outcome|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
211306|NCT01159535|E3|Reported Event|Treatment as Usual (TAU)|Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.
211307|NCT01159535|E2|Reported Event|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
211308|NCT01159535|E1|Reported Event|Mindfulness-Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
211309|NCT01159431|B3|Baseline|Total|Total of all reporting groups
211310|NCT01159431|B2|Baseline|Control|Trigeminal Nerve Stimulation-Low Settings
211311|NCT01159431|B1|Baseline|Active|Trigeminal Nerve Stimulation-High Settings
211312|NCT01159431|P2|Participant Flow|Control|Trigeminal Nerve Stimulation-Low Settings
211313|NCT01159431|P1|Participant Flow|Active|Trigeminal Nerve Stimulation-High Settings
211314|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
211315|NCT01159431|O1|Outcome|Active|Trigeminal Nerve Stimulation-High Settings
211316|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
211317|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
211318|NCT01159431|O2|Outcome|Control|
211319|NCT01159431|O1|Outcome|Treatment|
211320|NCT01159431|O4|Outcome|Treatment Group-Double Blind Period|
211321|NCT01159431|O3|Outcome|Treatment Group-Baseline|
211322|NCT01159431|O2|Outcome|Control Group-Double Blind Period|Sham Treatment
211323|NCT01159431|O1|Outcome|Control Group-Baseline|Baseline
211324|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
211325|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
211326|NCT01159431|E2|Reported Event|Control|Trigeminal Nerve Stimulation-Low Settings
211327|NCT01159431|E1|Reported Event|Active|Trigeminal Nerve Stimulation-High Settings
211328|NCT01159262|B4|Baseline|Total|Total of all reporting groups
211524|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211330|NCT01159262|B2|Baseline|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211331|NCT01159262|B1|Baseline|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211332|NCT01159262|P3|Participant Flow|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211333|NCT01159262|P2|Participant Flow|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211334|NCT01159262|P1|Participant Flow|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211335|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211336|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211337|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211338|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211339|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211340|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211341|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211342|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211343|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211344|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211345|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211346|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211347|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211348|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211349|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211350|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211351|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211352|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211353|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
225977|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
211354|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211355|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211356|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211357|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211358|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211359|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211360|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211361|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211362|NCT01159262|E3|Reported Event|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211363|NCT01159262|E2|Reported Event|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211364|NCT01159262|E1|Reported Event|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
211365|NCT01159171|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211366|NCT01159171|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211367|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211368|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211369|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211370|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211371|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211372|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211373|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211374|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
225978|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
211375|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211376|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211377|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211378|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211379|NCT01159171|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
211380|NCT01158924|B3|Baseline|Total|Total of all reporting groups
211381|NCT01158924|B2|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211382|NCT01158924|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211383|NCT01158924|P2|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211384|NCT01158924|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211385|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211386|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211387|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211388|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211389|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211390|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211391|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211392|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211393|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211525|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211394|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211395|NCT01158924|E2|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211396|NCT01158924|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
211397|NCT01158716|B3|Baseline|Total|Total of all reporting groups
211398|NCT01158716|B2|Baseline|Control|
211399|NCT01158716|B1|Baseline|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
211400|NCT01158716|P2|Participant Flow|Control|
211401|NCT01158716|P1|Participant Flow|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
211402|NCT01158716|O2|Outcome|Control|
211403|NCT01158716|O1|Outcome|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
211404|NCT01158716|E2|Reported Event|Control|
211405|NCT01158716|E1|Reported Event|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
211406|NCT01158703|B3|Baseline|Total|Total of all reporting groups
211407|NCT01158703|B2|Baseline|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211408|NCT01158703|B1|Baseline|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211409|NCT01158703|P2|Participant Flow|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211410|NCT01158703|P1|Participant Flow|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211411|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211412|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211413|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211414|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211415|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211416|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211417|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211418|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211419|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211420|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211421|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211422|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211423|NCT01158703|E2|Reported Event|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
211424|NCT01158703|E1|Reported Event|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
211425|NCT01158534|B1|Baseline|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211426|NCT01158534|P1|Participant Flow|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211427|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211428|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211429|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211430|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211526|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211527|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211431|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211432|NCT01158534|E1|Reported Event|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
211433|NCT01158378|B3|Baseline|Total|Total of all reporting groups
211434|NCT01158378|B2|Baseline|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211435|NCT01158378|B1|Baseline|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
211436|NCT01158378|P2|Participant Flow|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211437|NCT01158378|P1|Participant Flow|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
211438|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211439|NCT01158378|O1|Outcome|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
211440|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211441|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
211442|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211443|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
211444|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211445|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
211446|NCT01158378|E2|Reported Event|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
211447|NCT01158378|E1|Reported Event|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
211448|NCT01158261|B1|Baseline|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
211449|NCT01158261|P1|Participant Flow|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
211450|NCT01158261|O1|Outcome|EVICEL® Fibrin Sealant (Human)|
211451|NCT01158261|E1|Reported Event|EVICEL® Fibrin Sealant (Human)|"An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator’s assessment.~In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation."
211452|NCT01157845|B1|Baseline|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
211453|NCT01157845|P1|Participant Flow|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
211454|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
211455|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
211456|NCT01157845|E1|Reported Event|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
211457|NCT01157533|B1|Baseline|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
211458|NCT01157533|P1|Participant Flow|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
211459|NCT01157533|O1|Outcome|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
211460|NCT01157533|E1|Reported Event|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
211461|NCT01156532|B1|Baseline|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211528|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211462|NCT01156532|P1|Participant Flow|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211463|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211464|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211465|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211466|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211467|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211468|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211469|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211470|NCT01156532|E1|Reported Event|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
211471|NCT01156480|B3|Baseline|Total|Total of all reporting groups
211472|NCT01156480|B2|Baseline|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211473|NCT01156480|B1|Baseline|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211474|NCT01156480|P2|Participant Flow|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211475|NCT01156480|P1|Participant Flow|Hydrocortisone|hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211476|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211477|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211529|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211530|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211478|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211479|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211480|NCT01156480|E2|Reported Event|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211481|NCT01156480|E1|Reported Event|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
211482|NCT01156376|B4|Baseline|Total|Total of all reporting groups
211483|NCT01156376|B3|Baseline|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211484|NCT01156376|B2|Baseline|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211485|NCT01156376|B1|Baseline|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211486|NCT01156376|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211487|NCT01156376|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211488|NCT01156376|P1|Participant Flow|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211489|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211490|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211491|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211492|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211493|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211494|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211495|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211496|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211497|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211498|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211499|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211500|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211501|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211502|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211503|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211504|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211505|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211506|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211507|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211508|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211509|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211510|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211511|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211512|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211513|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211514|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211515|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211516|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211517|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211518|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211519|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211520|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211521|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211522|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211523|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211531|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211533|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211534|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211535|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211536|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211537|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211538|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211539|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211540|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211541|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211542|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211543|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211544|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211545|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211546|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211547|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211548|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211549|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211550|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211551|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211552|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211553|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211554|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211555|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211556|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211557|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211558|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211559|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211560|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211561|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211562|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211563|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211564|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211565|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211566|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211567|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211568|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211569|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211570|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211571|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211572|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211573|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211574|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211575|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211576|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211577|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211578|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211579|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211580|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211581|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211582|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211583|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211584|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211585|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211586|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211587|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211588|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211589|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211590|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211591|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211592|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211593|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211594|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211595|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211596|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211597|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211598|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211599|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211600|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211601|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211602|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211603|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211604|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211605|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211606|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211607|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211608|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211609|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211610|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211611|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211612|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211613|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211614|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211615|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211616|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211617|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211618|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211619|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211620|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211621|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211622|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211623|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211624|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211625|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211626|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211627|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211628|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211629|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211630|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211631|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211632|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211633|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211634|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211635|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211636|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211637|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211638|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211639|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211640|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211641|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211642|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211643|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211644|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211645|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211646|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211647|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211648|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211649|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211650|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211651|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211652|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211653|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211654|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211655|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211656|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211657|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211658|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211659|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211660|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211661|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211662|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211663|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211664|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211665|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211666|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211667|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211668|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211669|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211670|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211671|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211672|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211673|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211674|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211675|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211676|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211677|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211678|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211679|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211680|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211681|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211682|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211683|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211684|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211685|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211686|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211687|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211688|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211689|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211690|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211691|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211692|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211693|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211694|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211695|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211696|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211697|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211698|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211699|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211700|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211701|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211702|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211703|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211704|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211705|NCT01156376|E3|Reported Event|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
211706|NCT01156376|E2|Reported Event|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
211707|NCT01156376|E1|Reported Event|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
211708|NCT01156363|B1|Baseline|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211788|NCT01157351|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211709|NCT01156363|P1|Participant Flow|Mircera|"Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.~This arm includes participants enrolled at all 3 centers."
211710|NCT01156363|O1|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211711|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211712|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
211713|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
211714|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
211715|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211716|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
211717|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
211718|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
211719|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211720|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
211721|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
211722|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
211723|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211724|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
211725|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
211726|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
211727|NCT01156363|E1|Reported Event|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
211729|NCT01156311|B2|Baseline|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211730|NCT01156311|B1|Baseline|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211731|NCT01156311|P4|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to GA|"Dimethyl fumarate was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).~Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study."
211732|NCT01156311|P3|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß|"BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß.~Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study."
211733|NCT01156311|P2|Participant Flow|Monotherapy Period: Glatiramer Acetate (GA)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
211734|NCT01156311|P1|Participant Flow|Monotherapy Period: Interferon Beta (IFNß)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
211735|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211736|NCT01156311|O1|Outcome|Interferon Beta 1a (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211737|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211738|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211739|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211740|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211741|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211742|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211743|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211744|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211745|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211746|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211747|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211846|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211847|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211748|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211749|NCT01156311|O2|Outcome|Monotherapy Period: GA|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
211750|NCT01156311|O1|Outcome|Monotherapy Period: IFNß|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
211751|NCT01156311|E4|Reported Event|Add-on Therapy Period: GA and BG00012|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211752|NCT01156311|E3|Reported Event|Add-on Therapy Period: IFNß and BG00012|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
211753|NCT01156311|E2|Reported Event|Monotherapy Period: GA|A stable dose of GA for up to 8 weeks (until the first dose of BG00012).
211754|NCT01156311|E1|Reported Event|Monotherapy Period: IFNß|A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012).
211755|NCT01157377|B8|Baseline|Total|Total of all reporting groups
211756|NCT01157377|B7|Baseline|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
211757|NCT01157377|B6|Baseline|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
211758|NCT01157377|B5|Baseline|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
211759|NCT01157377|B4|Baseline|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
211760|NCT01157377|B3|Baseline|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
211761|NCT01157377|B2|Baseline|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
211762|NCT01157377|B1|Baseline|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
211763|NCT01157377|P7|Participant Flow|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
211764|NCT01157377|P6|Participant Flow|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
211765|NCT01157377|P5|Participant Flow|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
211766|NCT01157377|P4|Participant Flow|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
211767|NCT01157377|P3|Participant Flow|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
211768|NCT01157377|P2|Participant Flow|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
211769|NCT01157377|P1|Participant Flow|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
211770|NCT01157377|O7|Outcome|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
211771|NCT01157377|O6|Outcome|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
211772|NCT01157377|O5|Outcome|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
211773|NCT01157377|O4|Outcome|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
211774|NCT01157377|O3|Outcome|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
211775|NCT01157377|O2|Outcome|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
211776|NCT01157377|O1|Outcome|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
211777|NCT01157377|E7|Reported Event|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
211778|NCT01157377|E6|Reported Event|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
211779|NCT01157377|E5|Reported Event|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
211780|NCT01157377|E4|Reported Event|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
211781|NCT01157377|E3|Reported Event|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
211782|NCT01157377|E2|Reported Event|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
211783|NCT01157377|E1|Reported Event|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
211784|NCT01157351|B3|Baseline|Total|Total of all reporting groups
211785|NCT01157351|B2|Baseline|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211786|NCT01157351|B1|Baseline|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211787|NCT01157351|P2|Participant Flow|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211893|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211789|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211790|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211791|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211792|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211793|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211794|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211795|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211796|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211797|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211798|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211799|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211800|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211801|NCT01157351|E2|Reported Event|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
211802|NCT01157351|E1|Reported Event|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
211803|NCT01157234|B3|Baseline|Total|Total of all reporting groups
211804|NCT01157234|B2|Baseline|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211805|NCT01157234|B1|Baseline|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211806|NCT01157234|P2|Participant Flow|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211807|NCT01157234|P1|Participant Flow|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211808|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211809|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211810|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211811|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211812|NCT01157234|O2|Outcome|Metoprolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211813|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211814|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211815|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
213359|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
211816|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211817|NCT01157234|O1|Outcome|Nebivolol < 50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211818|NCT01157234|O2|Outcome|Metoprolol >/= 50 Year Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
211819|NCT01157234|O1|Outcome|Nebivolol <50 Year Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
211820|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211821|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211822|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211823|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211824|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211825|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211826|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211827|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211828|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211829|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211830|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211831|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211832|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211833|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
211834|NCT01157234|E2|Reported Event|Metoprolol|"Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90."
211835|NCT01157234|E1|Reported Event|Nebivolol|"Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90."
211836|NCT01157182|B3|Baseline|Total|Total of all reporting groups
211837|NCT01157182|B2|Baseline|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
211838|NCT01157182|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
211839|NCT01157182|P2|Participant Flow|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
211840|NCT01157182|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
211841|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211842|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211843|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211844|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211845|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
225979|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
211848|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211849|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211850|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211851|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211852|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211853|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211854|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211855|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211856|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211857|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211858|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211859|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211860|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211861|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211862|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211863|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211864|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211865|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211866|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211867|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211868|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211869|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211870|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211871|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211872|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211873|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211874|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211875|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211876|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211877|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211878|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211879|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211880|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211881|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
211882|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
211883|NCT01157182|E2|Reported Event|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
211884|NCT01157182|E1|Reported Event|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
211885|NCT01157169|B3|Baseline|Total|Total of all reporting groups
211886|NCT01157169|B2|Baseline|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
211887|NCT01157169|B1|Baseline|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
211888|NCT01157169|P2|Participant Flow|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
211889|NCT01157169|P1|Participant Flow|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
211890|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
211891|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211892|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
213360|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
211894|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
211895|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211896|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
211897|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211898|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
211899|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211900|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
211901|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
211902|NCT01157169|E2|Reported Event|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
211903|NCT01157169|E1|Reported Event|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
211904|NCT01157117|B4|Baseline|Total|Total of all reporting groups
211905|NCT01157117|B3|Baseline|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211906|NCT01157117|B2|Baseline|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211907|NCT01157117|B1|Baseline|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211908|NCT01157117|P3|Participant Flow|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211909|NCT01157117|P2|Participant Flow|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211910|NCT01157117|P1|Participant Flow|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211911|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211912|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211913|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211914|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211951|NCT01157078|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211952|NCT01157078|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211915|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211916|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211917|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211918|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211919|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211920|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211921|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211922|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211923|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211924|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211925|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211926|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211953|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211954|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211955|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
212003|NCT01157065|P1|Participant Flow|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
211927|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211928|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211929|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211930|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211931|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211932|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211933|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211934|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211935|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211936|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211956|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211957|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211937|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211938|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211939|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211940|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211941|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211942|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211943|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211944|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211945|NCT01157117|E3|Reported Event|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
211946|NCT01157117|E2|Reported Event|Placebo for Omalizumab/Milk OIT|Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight).
211947|NCT01157117|E1|Reported Event|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
211948|NCT01157078|B3|Baseline|Total|Total of all reporting groups
211949|NCT01157078|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211950|NCT01157078|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211958|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211959|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211960|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211961|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211962|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211963|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211964|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211965|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211966|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211967|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211968|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211969|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211970|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211971|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211972|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211973|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211974|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211975|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211976|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211977|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211978|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211979|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211980|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211981|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211982|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211983|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211984|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211985|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211986|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211987|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211988|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211989|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211990|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211991|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211992|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211993|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211994|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211995|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211996|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211997|NCT01157078|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
211998|NCT01157078|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
211999|NCT01157065|B3|Baseline|Total|Total of all reporting groups
212000|NCT01157065|B2|Baseline|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212001|NCT01157065|B1|Baseline|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212002|NCT01157065|P2|Participant Flow|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212004|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212005|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212006|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212007|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212008|NCT01157065|E2|Reported Event|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212009|NCT01157065|E1|Reported Event|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
212010|NCT01156987|B3|Baseline|Total|Total of all reporting groups
212011|NCT01156987|B2|Baseline|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
212012|NCT01156987|B1|Baseline|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
212013|NCT01156987|P2|Participant Flow|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
212014|NCT01156987|P1|Participant Flow|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
212015|NCT01156987|O2|Outcome|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
212016|NCT01156987|O1|Outcome|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
212029|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212114|NCT01156701|P1|Participant Flow|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212017|NCT01156987|E2|Reported Event|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
212018|NCT01156987|E1|Reported Event|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
212019|NCT01156844|B5|Baseline|Total|Total of all reporting groups
212020|NCT01156844|B4|Baseline|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212021|NCT01156844|B3|Baseline|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212022|NCT01156844|B2|Baseline|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212023|NCT01156844|B1|Baseline|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212024|NCT01156844|P4|Participant Flow|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212025|NCT01156844|P3|Participant Flow|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212026|NCT01156844|P2|Participant Flow|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212027|NCT01156844|P1|Participant Flow|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212028|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
212111|NCT01156701|P4|Participant Flow|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212030|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212031|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
212032|NCT01156844|O2|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212033|NCT01156844|O1|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212034|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
212035|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212036|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212037|NCT01156844|O4|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212038|NCT01156844|O3|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212039|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212040|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212041|NCT01156844|E4|Reported Event|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212042|NCT01156844|E3|Reported Event|Indacaterol 150 ug (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212043|NCT01156844|E2|Reported Event|Indacaterol 75 ug (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212044|NCT01156844|E1|Reported Event|Indacaterol 37.5 ug (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
212045|NCT01156792|B1|Baseline|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
212046|NCT01156792|P1|Participant Flow|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
212047|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212048|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212049|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212050|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212051|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212052|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212053|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212054|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212055|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212056|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212057|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212058|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
213361|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
212059|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212060|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212061|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212062|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212063|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212064|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212065|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212066|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212067|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212068|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212069|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212070|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212071|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212072|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212073|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212074|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212075|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212112|NCT01156701|P3|Participant Flow|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212076|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212077|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212078|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212079|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212080|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212081|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212082|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212083|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212084|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212085|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212086|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212087|NCT01156792|O3|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212088|NCT01156792|O2|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212089|NCT01156792|O1|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212090|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212091|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212092|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212113|NCT01156701|P2|Participant Flow|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212093|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212094|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212095|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212096|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212097|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212098|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212099|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212100|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212101|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212102|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212103|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212104|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212105|NCT01156792|E5|Reported Event|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212106|NCT01156792|E4|Reported Event|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
212107|NCT01156792|E3|Reported Event|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212108|NCT01156792|E2|Reported Event|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
212109|NCT01156792|E1|Reported Event|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
212110|NCT01156701|B1|Baseline|All Patients Included in the Analysis|All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
212115|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212116|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212117|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212118|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212119|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212120|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212121|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212122|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212123|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212124|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212125|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212126|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212127|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212128|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212129|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212130|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212131|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212132|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212133|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212134|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212135|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212136|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212137|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212138|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212139|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212140|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212141|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212142|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212143|NCT01156701|E4|Reported Event|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
212144|NCT01156701|E3|Reported Event|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212145|NCT01156701|E2|Reported Event|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212146|NCT01156701|E1|Reported Event|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
212147|NCT01156597|B3|Baseline|Total|Total of all reporting groups
212148|NCT01156597|B2|Baseline|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212149|NCT01156597|B1|Baseline|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212150|NCT01156597|P2|Participant Flow|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212151|NCT01156597|P1|Participant Flow|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212152|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212153|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212154|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212155|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212156|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212157|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212158|NCT01156597|E2|Reported Event|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
212159|NCT01156597|E1|Reported Event|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
212160|NCT01156571|B3|Baseline|Total|Total of all reporting groups
212161|NCT01156571|B2|Baseline|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
212162|NCT01156571|B1|Baseline|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
225980|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
212163|NCT01156571|P2|Participant Flow|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
212164|NCT01156571|P1|Participant Flow|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
212165|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
212166|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
212167|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
212168|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
212169|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
212170|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
212171|NCT01156571|E2|Reported Event|Clopidogrel Treatment Arm|
212172|NCT01156571|E1|Reported Event|Cangrelor Treatment Arm|
212173|NCT01156116|B3|Baseline|Total|Total of all reporting groups
212174|NCT01156116|B2|Baseline|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212175|NCT01156116|B1|Baseline|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212176|NCT01156116|P2|Participant Flow|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212177|NCT01156116|P1|Participant Flow|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212178|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212179|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212180|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212181|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212182|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212183|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212184|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212185|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212186|NCT01156116|E2|Reported Event|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
212187|NCT01156116|E1|Reported Event|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
212188|NCT01156051|B3|Baseline|Total|Total of all reporting groups
212189|NCT01156051|B2|Baseline|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212190|NCT01156051|B1|Baseline|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212191|NCT01156051|P2|Participant Flow|Control|Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.
212192|NCT01156051|P1|Participant Flow|Treatment Group|Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
212193|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
212194|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212195|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
212196|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212197|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
212198|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212199|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
212200|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212201|NCT01156051|E2|Reported Event|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
212202|NCT01156051|E1|Reported Event|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
212203|NCT01156012|B3|Baseline|Total|Total of all reporting groups
212204|NCT01156012|B2|Baseline|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
212205|NCT01156012|B1|Baseline|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
212206|NCT01156012|P2|Participant Flow|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
212207|NCT01156012|P1|Participant Flow|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm"
212208|NCT01156012|O2|Outcome|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
212209|NCT01156012|O1|Outcome|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
212210|NCT01156012|E2|Reported Event|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
212211|NCT01156012|E1|Reported Event|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
212212|NCT01155999|B3|Baseline|Total|Total of all reporting groups
212213|NCT01155999|B2|Baseline|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
212214|NCT01155999|B1|Baseline|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
212215|NCT01155999|P2|Participant Flow|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
212216|NCT01155999|P1|Participant Flow|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
212217|NCT01155999|O2|Outcome|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
212218|NCT01155999|O1|Outcome|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
212219|NCT01155999|E2|Reported Event|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
212220|NCT01155999|E1|Reported Event|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
212221|NCT01155869|B3|Baseline|Total|Total of all reporting groups
212222|NCT01155869|B2|Baseline|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
212223|NCT01155869|B1|Baseline|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
212224|NCT01155869|P2|Participant Flow|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
212225|NCT01155869|P1|Participant Flow|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
212226|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
212227|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
212228|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
212229|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
212230|NCT01155869|E2|Reported Event|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
212231|NCT01155869|E1|Reported Event|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
212232|NCT01155830|B4|Baseline|Total|Total of all reporting groups
212233|NCT01155830|B3|Baseline|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
212234|NCT01155830|B2|Baseline|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
212235|NCT01155830|B1|Baseline|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
212236|NCT01155830|P3|Participant Flow|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
212237|NCT01155830|P2|Participant Flow|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
212238|NCT01155830|P1|Participant Flow|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
212239|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
212240|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
212241|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
212242|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
212243|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
212244|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
212245|NCT01155830|E3|Reported Event|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
212246|NCT01155830|E2|Reported Event|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
212247|NCT01155830|E1|Reported Event|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
212248|NCT01155726|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
212249|NCT01155726|P4|Participant Flow|Etafilcon A, Masked, Partially Masked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
213362|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
212250|NCT01155726|P3|Participant Flow|Etafilcon A, Masked, Unmasked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
212251|NCT01155726|P2|Participant Flow|Nelfilcon A, Masked, Partially Masked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
212252|NCT01155726|P1|Participant Flow|Nelfilcon A, Masked, Unmasked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
212253|NCT01155726|O16|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212254|NCT01155726|O15|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212255|NCT01155726|O14|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212256|NCT01155726|O13|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212257|NCT01155726|O12|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212258|NCT01155726|O11|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212259|NCT01155726|O10|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212260|NCT01155726|O9|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
212261|NCT01155726|O8|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212262|NCT01155726|O7|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212263|NCT01155726|O6|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212264|NCT01155726|O5|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212265|NCT01155726|O4|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212266|NCT01155726|O3|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212267|NCT01155726|O2|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212268|NCT01155726|O1|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
212269|NCT01155726|E4|Reported Event|DACP|Nelfilcon A with comfort additive contact lenses
212270|NCT01155726|E3|Reported Event|1DAVM|Etafilcon A with comfort additive contact lenses
212271|NCT01155726|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses
212272|NCT01155726|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses
212273|NCT01155570|B1|Baseline|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212274|NCT01155570|P1|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212275|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212276|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212277|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212278|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212279|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212280|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212281|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212282|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212283|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212284|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212285|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212286|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212287|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
212288|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
213363|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
212289|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
212290|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212291|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
212292|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212293|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
212294|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212295|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212296|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212297|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212298|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212299|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212300|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212301|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212302|NCT01155570|E1|Reported Event|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
212303|NCT01155531|B5|Baseline|Total|Total of all reporting groups
212304|NCT01155531|B4|Baseline|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212305|NCT01155531|B3|Baseline|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212306|NCT01155531|B2|Baseline|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212307|NCT01155531|B1|Baseline|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212308|NCT01155531|P4|Participant Flow|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212309|NCT01155531|P3|Participant Flow|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212310|NCT01155531|P2|Participant Flow|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212311|NCT01155531|P1|Participant Flow|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212312|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212313|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212314|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212315|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212316|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212317|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212318|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212319|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212320|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212321|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212322|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212323|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212324|NCT01155531|E4|Reported Event|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212325|NCT01155531|E3|Reported Event|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212326|NCT01155531|E2|Reported Event|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212327|NCT01155531|E1|Reported Event|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
212328|NCT01155479|B6|Baseline|Total|Total of all reporting groups
212329|NCT01155479|B5|Baseline|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212330|NCT01155479|B4|Baseline|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
212331|NCT01155479|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212332|NCT01155479|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212333|NCT01155479|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212334|NCT01155479|P5|Participant Flow|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212335|NCT01155479|P4|Participant Flow|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
212336|NCT01155479|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212337|NCT01155479|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212338|NCT01155479|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212339|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
212340|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212341|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212342|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212343|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
212344|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
212345|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212346|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212347|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212348|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
212349|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
212350|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
212351|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212352|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212353|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
212354|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
212355|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
212356|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212357|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212358|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
213364|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
212359|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
212360|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
212361|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212362|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212363|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
212364|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
212365|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
212366|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
212367|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
212368|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
212369|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
212370|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
212371|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
212372|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
212373|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
212374|NCT01155479|E10|Reported Event|Rasagiline - Part 2|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
212375|NCT01155479|E9|Reported Event|Placebo/Preladenant 5 Mg-Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
212376|NCT01155479|E8|Reported Event|Preladenant 10 mg - Part 2|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
212377|NCT01155479|E7|Reported Event|Preladenant 5 mg - Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
212378|NCT01155479|E6|Reported Event|Preladenant 2 mg - Part 2|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
212379|NCT01155479|E5|Reported Event|Rasagiline - Part 1|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
212380|NCT01155479|E4|Reported Event|Placebo - Part 1|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
212381|NCT01155479|E3|Reported Event|Preladenant 10 mg - Part 1|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
212382|NCT01155479|E2|Reported Event|Preladenant 5 mg - Part 1|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
212383|NCT01155479|E1|Reported Event|Preladenant 2 mg - Part 1|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
212384|NCT01155466|B6|Baseline|Total|Total of all reporting groups
212385|NCT01155466|B5|Baseline|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212386|NCT01155466|B4|Baseline|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212387|NCT01155466|B3|Baseline|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212388|NCT01155466|B2|Baseline|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212389|NCT01155466|B1|Baseline|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212390|NCT01155466|P5|Participant Flow|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212391|NCT01155466|P4|Participant Flow|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212392|NCT01155466|P3|Participant Flow|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212393|NCT01155466|P2|Participant Flow|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212394|NCT01155466|P1|Participant Flow|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212395|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212396|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212397|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212398|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212399|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212400|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212401|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212402|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212403|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212404|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212405|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212406|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212407|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212408|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212409|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212410|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212411|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212412|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212413|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212414|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212415|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212416|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212417|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212418|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212419|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212420|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212421|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212422|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212423|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212424|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212425|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212426|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212427|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212428|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212429|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212430|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212431|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212432|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212433|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212434|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212435|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212436|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212437|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212438|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212439|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212440|NCT01155466|E5|Reported Event|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
212441|NCT01155466|E4|Reported Event|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
212442|NCT01155466|E3|Reported Event|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
212443|NCT01155466|E2|Reported Event|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
212444|NCT01155466|E1|Reported Event|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
212445|NCT01155336|B3|Baseline|Total|Total of all reporting groups
212446|NCT01155336|B2|Baseline|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
212447|NCT01155336|B1|Baseline|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
212448|NCT01155336|P2|Participant Flow|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
212449|NCT01155336|P1|Participant Flow|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
212450|NCT01155336|O2|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
212451|NCT01155336|O1|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
212452|NCT01155336|E2|Reported Event|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
212453|NCT01155336|E1|Reported Event|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
212454|NCT01155323|B1|Baseline|Total Number of Participants|This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
212455|NCT01155323|P2|Participant Flow|Omafilcon A/Etafilcon A|omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
212456|NCT01155323|P1|Participant Flow|Etafilcon A/Omafilcon A|etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
212457|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212458|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212459|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212460|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212461|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212462|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212463|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212464|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212465|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212466|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212467|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
212468|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
212469|NCT01155323|E2|Reported Event|Omafilcon A|soft contact lens replaced daily, worn for one week.
212470|NCT01155323|E1|Reported Event|Etafilcon A|soft contact lens replaced daily, worn for one week.
212471|NCT01155219|B3|Baseline|Total|Total of all reporting groups
212472|NCT01155219|B2|Baseline|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
212508|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212473|NCT01155219|B1|Baseline|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
212474|NCT01155219|P2|Participant Flow|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
212475|NCT01155219|P1|Participant Flow|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
212476|NCT01155219|O2|Outcome|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
212477|NCT01155219|O1|Outcome|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
212478|NCT01155219|E2|Reported Event|Xalatan®|"Latanoprost~One drop in the conjunctival sac of each eye in the evening"
212479|NCT01155219|E1|Reported Event|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel)~One drop in the conjunctival sac of each eye in the morning"
212480|NCT01155167|B3|Baseline|Total|Total of all reporting groups
212481|NCT01155167|B2|Baseline|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212482|NCT01155167|B1|Baseline|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212483|NCT01155167|P2|Participant Flow|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212484|NCT01155167|P1|Participant Flow|Placebo|Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212485|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212486|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212487|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212488|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212489|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212490|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212491|NCT01155167|E2|Reported Event|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212492|NCT01155167|E1|Reported Event|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
212493|NCT01155154|B4|Baseline|Total|Total of all reporting groups
212494|NCT01155154|B3|Baseline|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
212495|NCT01155154|B2|Baseline|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
212496|NCT01155154|B1|Baseline|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
212497|NCT01155154|P3|Participant Flow|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
212498|NCT01155154|P2|Participant Flow|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
212499|NCT01155154|P1|Participant Flow|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
212500|NCT01155154|O3|Outcome|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
212501|NCT01155154|O2|Outcome|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
212502|NCT01155154|O1|Outcome|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
212503|NCT01155154|E3|Reported Event|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
212504|NCT01155154|E2|Reported Event|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
212505|NCT01155154|E1|Reported Event|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
212506|NCT01155141|B1|Baseline|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212507|NCT01155141|P1|Participant Flow|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212509|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212510|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212511|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212512|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212513|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212514|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212515|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212516|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
212517|NCT01155141|E1|Reported Event|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
212518|NCT01155063|B1|Baseline|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212519|NCT01155063|P1|Participant Flow|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212520|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212521|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212522|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212523|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212524|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212525|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212526|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212527|NCT01155063|E1|Reported Event|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
212528|NCT01155024|B1|Baseline|Entire Study Population|Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
212529|NCT01155024|P2|Participant Flow|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
212530|NCT01155024|P1|Participant Flow|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
212531|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
212532|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
212533|NCT01155024|O2|Outcome|Direct Manufactured Socket|Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
212534|NCT01155024|O1|Outcome|Traditional Socket|Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
212535|NCT01155024|E2|Reported Event|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
212536|NCT01155024|E1|Reported Event|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
212537|NCT01154985|B4|Baseline|Total|Total of all reporting groups
212538|NCT01154985|B3|Baseline|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
212539|NCT01154985|B2|Baseline|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
212540|NCT01154985|B1|Baseline|Placebo|Placebo: Placebo three times a day (TID) for 365 days
212541|NCT01154985|P3|Participant Flow|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
212542|NCT01154985|P2|Participant Flow|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
212543|NCT01154985|P1|Participant Flow|Placebo|Placebo: Placebo three times a day (TID) for 365 days
212544|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
212545|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
212546|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
212547|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
212548|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
212549|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
212550|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
212557|NCT01154673|B2|Baseline|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
212558|NCT01154673|B1|Baseline|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
212559|NCT01154673|P2|Participant Flow|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks
212560|NCT01154673|P1|Participant Flow|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks"
212561|NCT01154673|O2|Outcome|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
212562|NCT01154673|O1|Outcome|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
212563|NCT01154673|E2|Reported Event|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
212564|NCT01154673|E1|Reported Event|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
212565|NCT01154634|B5|Baseline|Total|Total of all reporting groups
212566|NCT01154634|B4|Baseline|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212567|NCT01154634|B3|Baseline|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212568|NCT01154634|B2|Baseline|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212569|NCT01154634|B1|Baseline|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212570|NCT01154634|P4|Participant Flow|First Placebo, Then 40 mg, Then 5 mg, Then 16 mg|period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
212571|NCT01154634|P3|Participant Flow|First 16 mg, Then 5 mg, Then 40 mg, Then Placebo|period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
212572|NCT01154634|P2|Participant Flow|First 40 mg, Then 16 mg, Then Placebo, Then 5 mg|period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
212573|NCT01154634|P1|Participant Flow|First 5 mg, Then Placebo, Then 16 mg, Then 40 mg|period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
212574|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212575|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212576|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212577|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212578|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212579|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212580|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212581|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212582|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212583|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212584|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212585|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212586|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212587|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212588|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212589|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212590|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212591|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212592|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212593|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212594|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212595|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212596|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212597|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212598|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212599|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212600|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212601|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212602|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212603|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212604|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212605|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212606|NCT01154634|E4|Reported Event|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
212607|NCT01154634|E3|Reported Event|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
212608|NCT01154634|E2|Reported Event|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
212609|NCT01154634|E1|Reported Event|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
212610|NCT01154452|B5|Baseline|Total|Total of all reporting groups
212611|NCT01154452|B4|Baseline|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
212612|NCT01154452|B3|Baseline|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
212613|NCT01154452|B2|Baseline|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
212614|NCT01154452|B1|Baseline|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
212615|NCT01154452|P4|Participant Flow|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
212616|NCT01154452|P3|Participant Flow|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
212617|NCT01154452|P2|Participant Flow|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
212618|NCT01154452|P1|Participant Flow|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
212619|NCT01154452|O4|Outcome|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
212620|NCT01154452|O3|Outcome|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
212621|NCT01154452|O2|Outcome|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
212622|NCT01154452|O1|Outcome|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
212623|NCT01154452|O1|Outcome|All Phase Ib Participants|All Phase Ib Participants
212624|NCT01154452|E4|Reported Event|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
212625|NCT01154452|E3|Reported Event|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
212626|NCT01154452|E2|Reported Event|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
212627|NCT01154452|E1|Reported Event|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
212628|NCT01154335|B4|Baseline|Total|Total of all reporting groups
212629|NCT01154335|B3|Baseline|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
212630|NCT01154335|B2|Baseline|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
212631|NCT01154335|B1|Baseline|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
212632|NCT01154335|P3|Participant Flow|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
212633|NCT01154335|P2|Participant Flow|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
212634|NCT01154335|P1|Participant Flow|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
212635|NCT01154335|O1|Outcome|All Patients|Response Rate was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
212636|NCT01154335|O1|Outcome|All Patients|Overall Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
213365|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
212637|NCT01154335|O1|Outcome|All Patients|Progression-Free Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
212638|NCT01154335|O1|Outcome|All Patients|Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
212639|NCT01154335|E1|Reported Event|All Patients|Adverse Event data was was calculated for all patients at all dose levels
212640|NCT01154322|B1|Baseline|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
212641|NCT01154322|P1|Participant Flow|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
212642|NCT01154322|O1|Outcome|Pixi Mask|AHI with Pixi mask
212643|NCT01154322|O1|Outcome|Currently-used Mask|Baseline AHI prior to Pixi mask use
212644|NCT01154322|E1|Reported Event|Overall Study|
212645|NCT01154296|B3|Baseline|Total|Total of all reporting groups
212646|NCT01154296|B2|Baseline|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212647|NCT01154296|B1|Baseline|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212648|NCT01154296|P2|Participant Flow|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212649|NCT01154296|P1|Participant Flow|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212650|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212651|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212652|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212653|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212654|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212669|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212670|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
213366|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
212655|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212656|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212657|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212658|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212659|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212660|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212661|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212662|NCT01154296|E2|Reported Event|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
212663|NCT01154296|E1|Reported Event|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
212664|NCT01154283|B3|Baseline|Total|Total of all reporting groups
212665|NCT01154283|B2|Baseline|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
212666|NCT01154283|B1|Baseline|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
212667|NCT01154283|P2|Participant Flow|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
212668|NCT01154283|P1|Participant Flow|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
213367|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
212671|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212672|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212673|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212674|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212675|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212676|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
212677|NCT01154283|E2|Reported Event|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
212678|NCT01154283|E1|Reported Event|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
212679|NCT01154218|B1|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
212680|NCT01154218|P4|Participant Flow|Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted|Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
212681|NCT01154218|P3|Participant Flow|Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted|Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
212682|NCT01154218|P2|Participant Flow|Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted|Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
212683|NCT01154218|P1|Participant Flow|Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed|Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
212684|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212685|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212686|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212687|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212688|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212689|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212690|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212691|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212692|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212693|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212694|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212695|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212696|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212697|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
213368|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
212698|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212699|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212700|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212701|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212702|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212703|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212704|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212705|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212706|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212707|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212708|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212709|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212710|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212711|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212712|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212713|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212714|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212715|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212716|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212717|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212718|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212719|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212720|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212721|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212722|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212723|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212724|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212725|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212726|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212727|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212728|NCT01154218|E4|Reported Event|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
212729|NCT01154218|E3|Reported Event|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
212730|NCT01154218|E2|Reported Event|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
212731|NCT01154218|E1|Reported Event|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
212732|NCT01154166|B3|Baseline|Total|Total of all reporting groups
212733|NCT01154166|B2|Baseline|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
213262|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
212734|NCT01154166|B1|Baseline|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212735|NCT01154166|P2|Participant Flow|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212736|NCT01154166|P1|Participant Flow|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212737|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212738|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212739|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212740|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212741|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212742|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212743|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212875|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212744|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212745|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212746|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212747|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212748|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212749|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212750|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212751|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212752|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212753|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212876|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212877|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212754|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212755|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212756|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212757|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212758|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212759|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212760|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212761|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212762|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212763|NCT01154166|E2|Reported Event|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
212878|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
225981|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
212764|NCT01154166|E1|Reported Event|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
212765|NCT01154153|B3|Baseline|Total|Total of all reporting groups
212766|NCT01154153|B2|Baseline|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212767|NCT01154153|B1|Baseline|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212768|NCT01154153|P2|Participant Flow|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212769|NCT01154153|P1|Participant Flow|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212770|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212771|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212772|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212773|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212774|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212775|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212776|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212777|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212778|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212779|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212780|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212781|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212782|NCT01154153|E2|Reported Event|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212783|NCT01154153|E1|Reported Event|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
212784|NCT01154140|B3|Baseline|Total|Total of all reporting groups
212785|NCT01154140|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212786|NCT01154140|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212879|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212787|NCT01154140|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212788|NCT01154140|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212789|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212790|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212791|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212792|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212793|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212794|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212795|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212796|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212797|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212798|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212799|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212800|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
213355|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
212801|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212802|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212803|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212804|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212805|NCT01154140|O3|Outcome|Crizotinib (Cycle 5 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 5 Day 1. Treatment cycle was defined as 3 weeks.
212806|NCT01154140|O2|Outcome|Crizotinib (Cycle 3 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 3 Day 1. Treatment cycle was defined as 3 weeks.
212807|NCT01154140|O1|Outcome|Crizotinib (Cycle 2 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 2 Day 1. Treatment cycle was defined as 3 weeks.
212808|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212809|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212810|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212811|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212812|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212813|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212814|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212815|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212816|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212817|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212818|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212819|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212820|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212821|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212822|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212823|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212824|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212825|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212826|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212827|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212828|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212829|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212830|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
213356|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
212831|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212832|NCT01154140|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
212833|NCT01154140|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
212834|NCT01154127|B3|Baseline|Total|Total of all reporting groups
212835|NCT01154127|B2|Baseline|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212836|NCT01154127|B1|Baseline|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212837|NCT01154127|P2|Participant Flow|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212838|NCT01154127|P1|Participant Flow|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212839|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212840|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212841|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212842|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212843|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212844|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212845|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212846|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212847|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212848|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212849|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212850|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212851|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212852|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212853|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212854|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212855|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212856|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212857|NCT01154127|E2|Reported Event|Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212858|NCT01154127|E1|Reported Event|NVA237|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
212859|NCT01154036|B4|Baseline|Total|Total of all reporting groups
212860|NCT01154036|B3|Baseline|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
212861|NCT01154036|B2|Baseline|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212862|NCT01154036|B1|Baseline|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212863|NCT01154036|P8|Participant Flow|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212864|NCT01154036|P7|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212865|NCT01154036|P6|Participant Flow|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212866|NCT01154036|P5|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212867|NCT01154036|P4|Participant Flow|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212868|NCT01154036|P3|Participant Flow|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212869|NCT01154036|P2|Participant Flow|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212870|NCT01154036|P1|Participant Flow|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212871|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212872|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212873|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212874|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
213029|NCT01153958|E2|Reported Event|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
212880|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212881|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212882|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212883|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212884|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212885|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212886|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212887|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212888|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212889|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212890|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212891|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212892|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212893|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212894|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212895|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212896|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212897|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212898|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212899|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212900|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212901|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212902|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212903|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212904|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212905|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212906|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212907|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212908|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212909|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212910|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212911|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212912|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212913|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212914|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212915|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212916|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212917|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212918|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212919|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212920|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212921|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212922|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212923|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212924|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212925|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212926|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212927|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212928|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212929|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212930|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212931|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212932|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212933|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212934|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212935|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212936|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212937|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212938|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212939|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212940|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212941|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212942|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212943|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212944|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212945|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212946|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212947|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212948|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212949|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212950|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
225982|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
212951|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212952|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212953|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212954|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212955|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212956|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212957|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212958|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212959|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212960|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212961|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212962|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212963|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212964|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212965|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212966|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212967|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212968|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212969|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212970|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212971|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212972|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212973|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212974|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212975|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212976|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212977|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212978|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212979|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212980|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
212981|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212982|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212983|NCT01154036|E8|Reported Event|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
212984|NCT01154036|E7|Reported Event|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212985|NCT01154036|E6|Reported Event|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
212986|NCT01154036|E5|Reported Event|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
212987|NCT01154036|E4|Reported Event|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
212988|NCT01154036|E3|Reported Event|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
212989|NCT01154036|E2|Reported Event|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
212990|NCT01154036|E1|Reported Event|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
212991|NCT01153971|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212992|NCT01153971|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212993|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212994|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212995|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212996|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212997|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213030|NCT01153958|E1|Reported Event|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213031|NCT01153893|B3|Baseline|Total|Total of all reporting groups
212998|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
212999|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213000|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213001|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213002|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213003|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213004|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213005|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213062|NCT01153815|P1|Participant Flow|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213155|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213006|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213007|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213008|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213009|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213010|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213011|NCT01153971|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
213012|NCT01153958|B3|Baseline|Total|Total of all reporting groups
213013|NCT01153958|B2|Baseline|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213014|NCT01153958|B1|Baseline|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213015|NCT01153958|P2|Participant Flow|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213016|NCT01153958|P1|Participant Flow|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213017|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213018|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213019|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213020|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213021|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213022|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213023|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213024|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213025|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213026|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213027|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
213028|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
213032|NCT01153893|B2|Baseline|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213033|NCT01153893|B1|Baseline|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213034|NCT01153893|P2|Participant Flow|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213035|NCT01153893|P1|Participant Flow|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213036|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213037|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213038|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213039|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213040|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213041|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213042|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213043|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213044|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213045|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213046|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213047|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213048|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213049|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213050|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213051|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213052|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213053|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213054|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213055|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213056|NCT01153893|E2|Reported Event|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213057|NCT01153893|E1|Reported Event|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
213058|NCT01153815|B3|Baseline|Total|Total of all reporting groups
213059|NCT01153815|B2|Baseline|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213060|NCT01153815|B1|Baseline|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213061|NCT01153815|P2|Participant Flow|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213221|NCT01153503|B2|Baseline|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
213063|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213064|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213065|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213066|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213067|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213068|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213069|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213070|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213071|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213072|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213073|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213074|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213075|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213076|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213077|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213078|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213079|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213080|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213081|NCT01153815|E2|Reported Event|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213082|NCT01153815|E1|Reported Event|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
213083|NCT01153763|B1|Baseline|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213084|NCT01153763|P1|Participant Flow|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213085|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213086|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213087|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213088|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213089|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213090|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213091|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213092|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
213093|NCT01153763|E1|Reported Event|All Patients|Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
213094|NCT01153724|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
213095|NCT01153724|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
213096|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213097|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213098|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213099|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213100|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213101|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213102|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213103|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213104|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213105|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213106|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213107|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213108|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213109|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213110|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213111|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213112|NCT01153724|E2|Reported Event|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
213113|NCT01153724|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213114|NCT01153711|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
213261|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213115|NCT01153711|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
213116|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213117|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213118|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213119|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213120|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213121|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213122|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213123|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213124|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213125|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213126|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213127|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213128|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213129|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213130|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213131|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213132|NCT01153711|E2|Reported Event|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
213133|NCT01153711|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
213134|NCT01153698|B1|Baseline|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213135|NCT01153698|P1|Participant Flow|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213136|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213137|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213138|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213139|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213140|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213141|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213142|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213143|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213144|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213145|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
213146|NCT01153698|E2|Reported Event|Pradaxa 220mg|All patients treated with Pradaxa
213147|NCT01153698|E1|Reported Event|Enoxaparin 40mg|All patients treated with enoxaparin
213148|NCT01153685|B3|Baseline|Total|Total of all reporting groups
213149|NCT01153685|B2|Baseline|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213150|NCT01153685|B1|Baseline|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213151|NCT01153685|P2|Participant Flow|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213152|NCT01153685|P1|Participant Flow|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213153|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213154|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213156|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213157|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213158|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213159|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213160|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213161|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213162|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213163|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213164|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213165|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213166|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213167|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213168|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213169|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213170|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213171|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213172|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213173|NCT01153685|E2|Reported Event|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213174|NCT01153685|E1|Reported Event|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
213175|NCT01153672|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213176|NCT01153672|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213177|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213178|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213179|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213357|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213180|NCT01153672|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
213181|NCT01153633|B3|Baseline|Total|Total of all reporting groups
213182|NCT01153633|B2|Baseline|Normal Saline and Placebo Gel|Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
213183|NCT01153633|B1|Baseline|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
213184|NCT01153633|P2|Participant Flow|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213185|NCT01153633|P1|Participant Flow|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
213186|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213187|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213188|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213189|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213190|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213191|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213192|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213193|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213194|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213195|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213196|NCT01153633|O2|Outcome|Normal Saline and Inactive Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213197|NCT01153633|O1|Outcome|Prontosan Wound Irrigation Solution and Gel|Polihexanide 0.1%, Betaine 01.%, purified water, exipients
213198|NCT01153633|E2|Reported Event|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
213199|NCT01153633|E1|Reported Event|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
213200|NCT01153620|B3|Baseline|Total|Total of all reporting groups
213201|NCT01153620|B2|Baseline|Lavasept 0.04%|
213202|NCT01153620|B1|Baseline|Ringer's Solution|
213203|NCT01153620|P2|Participant Flow|Lavasept 0.04%|
213204|NCT01153620|P1|Participant Flow|Ringer's Solution|
213205|NCT01153620|O2|Outcome|Ringer's Solution|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
213206|NCT01153620|O1|Outcome|Lavasept 0.04%|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
213207|NCT01153620|E2|Reported Event|Lavasept 0.04%|
213208|NCT01153620|E1|Reported Event|Ringer's Solution|
213209|NCT01153581|B1|Baseline|Women|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
213210|NCT01153581|P1|Participant Flow|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
213211|NCT01153581|O2|Outcome|Women Without Orthostatic Tolerance|Women who pass out easily with gravitational challenge
213212|NCT01153581|O1|Outcome|Women With Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
213213|NCT01153581|O2|Outcome|High Orthostatic Tolerant|Women who can tolerate posture changes
213214|NCT01153581|O1|Outcome|Low Orthostatic Tolerance|Women who pass out easily in response to posture change
213215|NCT01153581|O1|Outcome|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
213216|NCT01153581|E3|Reported Event|Progesterone|The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13–16.
213217|NCT01153581|E2|Reported Event|17β-Oestradiol|The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
213218|NCT01153581|E1|Reported Event|Ganirelix Acetate|Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
213219|NCT01153503|B4|Baseline|Total|Total of all reporting groups
213220|NCT01153503|B3|Baseline|Ketorolac 30 mg IV|"Ketorolac 30 mg, IV at the end of surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
213222|NCT01153503|B1|Baseline|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
213223|NCT01153503|P3|Participant Flow|Ketorolac 30 mg|"Ketorolac 30 mg, IV at the end of surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
213224|NCT01153503|P2|Participant Flow|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h Postoperative: IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
213225|NCT01153503|P1|Participant Flow|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
213226|NCT01153503|O3|Outcome|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
213227|NCT01153503|O2|Outcome|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
213228|NCT01153503|O1|Outcome|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
213229|NCT01153503|E3|Reported Event|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
213230|NCT01153503|E2|Reported Event|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
213231|NCT01153503|E1|Reported Event|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
213232|NCT01153347|B5|Baseline|Total|Total of all reporting groups
213233|NCT01153347|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213234|NCT01153347|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213235|NCT01153347|B2|Baseline|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213236|NCT01153347|B1|Baseline|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213237|NCT01153347|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213238|NCT01153347|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213239|NCT01153347|P2|Participant Flow|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213240|NCT01153347|P1|Participant Flow|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213241|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213242|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213243|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213244|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213245|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213246|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213247|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213248|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213249|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213250|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213251|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213252|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213253|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213254|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213255|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213256|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213257|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213258|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213259|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213260|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213263|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213264|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213265|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213266|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213267|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213268|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213269|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213270|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213271|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213272|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213273|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213274|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213275|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213276|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213277|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213278|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213279|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213280|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213281|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213282|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213283|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213284|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213285|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213286|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213287|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213288|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213289|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213290|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213291|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213292|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213293|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213294|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213295|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213296|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213297|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213298|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213299|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213300|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213301|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213302|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213303|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213304|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213305|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213306|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213307|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213308|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213309|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213310|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213311|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213312|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213313|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213314|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213315|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213316|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213317|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213318|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213319|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213320|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213321|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213322|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213323|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213324|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213325|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213326|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213327|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213328|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213329|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213330|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213331|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213332|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213333|NCT01153347|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
213334|NCT01153347|E3|Reported Event|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
213335|NCT01153347|E2|Reported Event|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
213336|NCT01153347|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
213337|NCT01153321|B3|Baseline|Total|Total of all reporting groups
213338|NCT01153321|B2|Baseline|Placebo|Placebo to match AZD2423 tablets, once daily
213339|NCT01153321|B1|Baseline|AZD2423|Two 50 mg AZD2423 tablets, once daily
213340|NCT01153321|P2|Participant Flow|Placebo|Placebo to match AZD2423 tablets, once daily
213341|NCT01153321|P1|Participant Flow|AZD2423|Two 50 mg AZD2423 tablets, once daily
213342|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213343|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213344|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213345|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213346|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213347|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213348|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213349|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213350|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213351|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213352|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213353|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213354|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213369|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213370|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213371|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213372|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213373|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213374|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213375|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213376|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213377|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213378|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213379|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213380|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213381|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213382|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213383|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213384|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213385|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213386|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213387|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213388|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213389|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213390|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213391|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213392|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213393|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213394|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213395|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213396|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213397|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213398|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213399|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213400|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213401|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213402|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213403|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213404|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213405|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213406|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213407|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213408|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213409|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213410|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213411|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213412|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213413|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213414|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213415|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213416|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213417|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213418|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213419|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213420|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213421|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213422|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213423|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213424|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213425|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213426|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213427|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213428|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213429|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213430|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213431|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213432|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213433|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213434|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213435|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213436|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213437|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213438|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213439|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213440|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213441|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213442|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213443|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213444|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213445|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213446|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213447|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213448|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
213449|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
213450|NCT01153321|E2|Reported Event|Placebo|Placebo to match AZD2423 tablets, once daily
213451|NCT01153321|E1|Reported Event|AZD2423 100 mg|
213452|NCT01153269|B1|Baseline|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213453|NCT01153269|P1|Participant Flow|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213454|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213455|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213456|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213457|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213458|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213459|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213460|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213461|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213462|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213463|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213464|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213465|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213466|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213467|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213468|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213469|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213470|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213471|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213472|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213473|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213474|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213475|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213476|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213477|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213478|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213479|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213480|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213481|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
213482|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213483|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213484|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213485|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213486|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213487|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213488|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213489|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213490|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213491|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213492|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213493|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213494|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213495|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213496|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213497|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213498|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213499|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213500|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213501|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213502|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213503|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213504|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213505|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213506|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213507|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213508|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213509|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
213510|NCT01153269|E1|Reported Event|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
213511|NCT01153009|B5|Baseline|Total|Total of all reporting groups
213512|NCT01153009|B4|Baseline|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213513|NCT01153009|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213514|NCT01153009|B2|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213515|NCT01153009|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213516|NCT01153009|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213517|NCT01153009|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213518|NCT01153009|P2|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213519|NCT01153009|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213520|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213521|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213522|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213523|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213524|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213525|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213526|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213527|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213528|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213529|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213530|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213531|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213532|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213533|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213534|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213535|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213536|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213537|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213538|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213539|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213540|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213541|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213542|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213543|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213544|NCT01153009|E4|Reported Event|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
213545|NCT01153009|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213546|NCT01153009|E2|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
213547|NCT01153009|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
213548|NCT01152996|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213549|NCT01152996|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213550|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213551|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213552|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213553|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213554|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213555|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213556|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213557|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213558|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213559|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213560|NCT01152996|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
213561|NCT01152814|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213562|NCT01152814|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213563|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213564|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213565|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213566|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213567|NCT01152814|E1|Reported Event|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
213568|NCT01152788|B3|Baseline|Total|Total of all reporting groups
213569|NCT01152788|B2|Baseline|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213570|NCT01152788|B1|Baseline|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213571|NCT01152788|P2|Participant Flow|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213572|NCT01152788|P1|Participant Flow|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213573|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213574|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213575|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213576|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213577|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213578|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213579|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213580|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213581|NCT01152788|E2|Reported Event|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
213582|NCT01152788|E1|Reported Event|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
213583|NCT01152697|B1|Baseline|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213584|NCT01152697|P1|Participant Flow|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
213585|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213586|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213587|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213588|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213589|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213590|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213591|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213632|NCT01152554|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213592|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213593|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213594|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213595|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213596|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213597|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213598|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213599|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213600|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213601|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213602|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213603|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213604|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213605|NCT01152697|E1|Reported Event|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
213606|NCT01152580|B3|Baseline|Total|Total of all reporting groups
213607|NCT01152580|B2|Baseline|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213608|NCT01152580|B1|Baseline|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213609|NCT01152580|P2|Participant Flow|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213610|NCT01152580|P1|Participant Flow|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213611|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213612|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213613|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213614|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213615|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213616|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213617|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213618|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213619|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213620|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213621|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213622|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213623|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213624|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213625|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213626|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213627|NCT01152580|E2|Reported Event|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
213628|NCT01152580|E1|Reported Event|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
213629|NCT01152554|B3|Baseline|Total|Total of all reporting groups
213630|NCT01152554|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213631|NCT01152554|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213633|NCT01152554|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213634|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213635|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213636|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213637|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213638|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213639|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213640|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213641|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213642|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213643|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213644|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213645|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213646|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213647|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213648|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213649|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213650|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
213651|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213652|NCT01152554|E2|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
213653|NCT01152554|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
213654|NCT01152450|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
213655|NCT01152450|P6|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 Bid|Patients treated with a matching Placebo in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213656|NCT01152450|P5|Participant Flow|Placebo/Tio R2.5 Bid/Tio R5 qd|Patients treated with matching Placebo in period 1 (morning and evening), with Tiotropium 2.5 mcg in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213657|NCT01152450|P4|Participant Flow|Tio R5 qd/Placebo/Tio R2.5 Bid|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with matching Placebo in period 2 (morning and evening) and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213658|NCT01152450|P3|Participant Flow|Tio R5 qd/Tio R2.5 Bid/Placebo|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with Tiotropium 2.5 mcg in period 2 (morning and evening) and with matching Placebo in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213659|NCT01152450|P2|Participant Flow|Tio R2.5 Bid/Placebo/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching Placebo in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213660|NCT01152450|P1|Participant Flow|Tio R2.5 Twice Daily (Bid) /Tio R5 Once Daily (qd) /Placebo|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with a matching Placebo in period 3 (morning and evening). All products were delivered by the Respimat inhaler, on top on maintenance therapy with inhaled corticosteroid (iCS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
213661|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213662|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213663|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213664|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213913|NCT01151436|O1|Outcome|Hyaluronic Acid|
213665|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213666|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213667|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213668|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213669|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213670|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213671|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213672|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213673|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213674|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213675|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213676|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213677|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213678|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213679|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213680|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213681|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213682|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213683|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213684|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213685|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213686|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213687|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213688|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213689|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213690|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213691|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213692|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213693|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213694|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213695|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213696|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213697|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213698|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213699|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213700|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213701|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213702|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213703|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213704|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213705|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213914|NCT01151436|O1|Outcome|Hyaluronic Acid|
213915|NCT01151436|O1|Outcome|Hyaluronic Acid|
213706|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213707|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213708|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213709|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213710|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213711|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213712|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213713|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213714|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213715|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213716|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213717|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213718|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213719|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213720|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213721|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213722|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213723|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213724|NCT01152450|E3|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213725|NCT01152450|E2|Reported Event|Tio R2.5|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213726|NCT01152450|E1|Reported Event|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
213727|NCT01152437|B4|Baseline|Total|Total of all reporting groups
213728|NCT01152437|B3|Baseline|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213729|NCT01152437|B2|Baseline|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213730|NCT01152437|B1|Baseline|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213731|NCT01152437|P3|Participant Flow|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213732|NCT01152437|P2|Participant Flow|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213733|NCT01152437|P1|Participant Flow|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213734|NCT01152437|O2|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213735|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213736|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213737|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213738|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213739|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213740|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213741|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213742|NCT01152437|O1|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213743|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213744|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213745|NCT01152437|E3|Reported Event|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213746|NCT01152437|E2|Reported Event|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
213747|NCT01152437|E1|Reported Event|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
213748|NCT01152385|B5|Baseline|Total|Total of all reporting groups
213749|NCT01152385|B4|Baseline|Placebo|Placebo
213750|NCT01152385|B3|Baseline|Low Dose|80 mg (daily dose)
213751|NCT01152385|B2|Baseline|Middle Dose|140 mg (daily dose)
213752|NCT01152385|B1|Baseline|High Dose|200 mg (daily dose)
213753|NCT01152385|P4|Participant Flow|Placebo|Placebo
213754|NCT01152385|P3|Participant Flow|Low Dose|80 mg (daily dose)
213755|NCT01152385|P2|Participant Flow|Middle Dose|140 mg (daily dose)
213756|NCT01152385|P1|Participant Flow|High Dose|200 mg (daily dose)
213757|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213758|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213759|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213760|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213761|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213762|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213763|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213764|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213765|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213766|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213767|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213768|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213769|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213770|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213771|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213772|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213773|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213774|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213775|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213776|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213777|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
213778|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213779|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213780|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213781|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
213782|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213783|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213784|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213785|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
213786|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
213787|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
213788|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
213789|NCT01152385|E4|Reported Event|Placebo|Placebo
213790|NCT01152385|E3|Reported Event|Low Dose|80 mg (daily dose)
213791|NCT01152385|E2|Reported Event|Middle Dose|140 mg (daily dose)
213792|NCT01152385|E1|Reported Event|High Dose|200 mg (daily dose)
213793|NCT01152359|B3|Baseline|Total|Total of all reporting groups
213794|NCT01152359|B2|Baseline|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213795|NCT01152359|B1|Baseline|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213916|NCT01151436|O1|Outcome|Hyaluronic Acid|
213796|NCT01152359|P2|Participant Flow|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213797|NCT01152359|P1|Participant Flow|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213798|NCT01152359|O2|Outcome|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213799|NCT01152359|O1|Outcome|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213800|NCT01152359|E2|Reported Event|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213801|NCT01152359|E1|Reported Event|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
213802|NCT01152307|B3|Baseline|Total|Total of all reporting groups
213803|NCT01152307|B2|Baseline|Control|Group not receiving the decision aid (DVD/booklet)
213804|NCT01152307|B1|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
213805|NCT01152307|P2|Participant Flow|Control|Group not receiving the decision aid (DVD/booklet)
213806|NCT01152307|P1|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
213807|NCT01152307|O2|Outcome|Control|Group not receiving the decision aid (DVD/booklet)
213808|NCT01152307|O1|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
213809|NCT01152307|E2|Reported Event|Control|Group not receiving the decision aid (DVD/booklet)
213810|NCT01152307|E1|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
213811|NCT01152294|B3|Baseline|Total|Total of all reporting groups
213812|NCT01152294|B2|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
213813|NCT01152294|B1|Baseline|Control|Group not receiving the decision aid (DVD and booklet)
213814|NCT01152294|P2|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
213815|NCT01152294|P1|Participant Flow|Control|Group not receiving the decision aid (DVD and booklet)
213816|NCT01152294|O2|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
213817|NCT01152294|O1|Outcome|Control|Group not receiving the decision aid (DVD and booklet)
213818|NCT01152294|E2|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
213819|NCT01152294|E1|Reported Event|Control|Group not receiving the decision aid (DVD and booklet)
213820|NCT01152190|B3|Baseline|Total|Total of all reporting groups
213821|NCT01152190|B2|Baseline|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213822|NCT01152190|B1|Baseline|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213823|NCT01152190|P2|Participant Flow|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213824|NCT01152190|P1|Participant Flow|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213825|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213826|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213827|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213828|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213829|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213830|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213831|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213832|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213833|NCT01152190|E2|Reported Event|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
213834|NCT01152190|E1|Reported Event|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
213835|NCT01151904|B1|Baseline|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213836|NCT01151904|P1|Participant Flow|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213837|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213838|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213839|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213840|NCT01151904|E1|Reported Event|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
213841|NCT01151852|B3|Baseline|Total|Total of all reporting groups
213842|NCT01151852|B2|Baseline|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213843|NCT01151852|B1|Baseline|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213844|NCT01151852|P2|Participant Flow|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213845|NCT01151852|P1|Participant Flow|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213846|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213847|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213848|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213849|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213850|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213851|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213852|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213853|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213854|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213855|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213856|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213857|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213858|NCT01151852|E2|Reported Event|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
213859|NCT01151852|E1|Reported Event|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
213917|NCT01151436|E1|Reported Event|Hyaluronic Acid|
213918|NCT01151410|B3|Baseline|Total|Total of all reporting groups
213860|NCT01151761|B1|Baseline|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
213861|NCT01151761|P1|Participant Flow|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
213862|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213863|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213864|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213865|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213866|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213867|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213868|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213869|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
213870|NCT01151761|E1|Reported Event|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
213871|NCT01151579|B3|Baseline|Total|Total of all reporting groups
213872|NCT01151579|B2|Baseline|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213873|NCT01151579|B1|Baseline|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213874|NCT01151579|P2|Participant Flow|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213875|NCT01151579|P1|Participant Flow|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213876|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213877|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213878|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213879|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213880|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213881|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213882|NCT01151579|E2|Reported Event|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
213883|NCT01151579|E1|Reported Event|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
213884|NCT01151553|B1|Baseline|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
213885|NCT01151553|P1|Participant Flow|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
213886|NCT01151553|O1|Outcome|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
213887|NCT01151553|E1|Reported Event|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
213888|NCT01151436|B1|Baseline|Hyaluronic Acid|
213889|NCT01151436|P1|Participant Flow|Hyaluronic Acid|
213890|NCT01151436|O1|Outcome|Hyaluronic Acid|
213891|NCT01151436|O1|Outcome|Hyaluronic Acid|
213892|NCT01151436|O1|Outcome|Hyaluronic Acid|
213893|NCT01151436|O1|Outcome|Hyaluronic Acid|
213894|NCT01151436|O1|Outcome|Hyaluronic Acid|
213895|NCT01151436|O1|Outcome|Hyaluronic Acid|
213896|NCT01151436|O1|Outcome|Hyaluronic Acid|
213897|NCT01151436|O1|Outcome|Hyaluronic Acid|
213898|NCT01151436|O1|Outcome|Hyaluronic Acid|
213899|NCT01151436|O1|Outcome|Hyaluronic Acid|
213900|NCT01151436|O1|Outcome|Hyaluronic Acid|
213901|NCT01151436|O1|Outcome|Hyaluronic Acid|
213902|NCT01151436|O1|Outcome|Hyaluronic Acid|
213903|NCT01151436|O1|Outcome|Hyaluronic Acid|
213904|NCT01151436|O1|Outcome|Hyaluronic Acid|
213905|NCT01151436|O1|Outcome|Hyaluronic Acid|
213906|NCT01151436|O1|Outcome|Hyaluronic Acid|
213907|NCT01151436|O1|Outcome|Hyaluronic Acid|
213908|NCT01151436|O1|Outcome|Hyaluronic Acid|
213909|NCT01151436|O1|Outcome|Hyaluronic Acid|
213910|NCT01151436|O1|Outcome|Hyaluronic Acid|
213911|NCT01151436|O1|Outcome|Hyaluronic Acid|
213912|NCT01151436|O1|Outcome|Hyaluronic Acid|
213919|NCT01151410|B2|Baseline|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213920|NCT01151410|B1|Baseline|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213921|NCT01151410|P2|Participant Flow|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213922|NCT01151410|P1|Participant Flow|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213923|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213924|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213925|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213926|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213927|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213928|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213929|NCT01151410|E2|Reported Event|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
213930|NCT01151410|E1|Reported Event|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
213931|NCT01151371|B4|Baseline|Total|Total of all reporting groups
213932|NCT01151371|B3|Baseline|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213933|NCT01151371|B2|Baseline|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213934|NCT01151371|B1|Baseline|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213935|NCT01151371|P3|Participant Flow|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213936|NCT01151371|P2|Participant Flow|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213937|NCT01151371|P1|Participant Flow|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213938|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213939|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213940|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213941|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213942|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213943|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213944|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213945|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213946|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213947|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213948|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213949|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213950|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213951|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213952|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213953|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213954|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213955|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213956|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213957|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213958|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213959|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213960|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213961|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213962|NCT01151371|E3|Reported Event|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
213963|NCT01151371|E2|Reported Event|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
213964|NCT01151371|E1|Reported Event|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
213965|NCT01151345|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
213966|NCT01151345|P2|Participant Flow|Angiotrofin 60 mg Then Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
213967|NCT01151345|P1|Participant Flow|Tilazem 60 mg Then Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
213968|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213969|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213970|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213971|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213972|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213973|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213974|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213975|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213976|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213977|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213978|NCT01151345|E2|Reported Event|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
213979|NCT01151345|E1|Reported Event|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
213980|NCT01151280|B1|Baseline|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213981|NCT01151280|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213982|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213983|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213984|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213985|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213986|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213987|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213988|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213989|NCT01151280|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
213990|NCT01151215|B4|Baseline|Total|Total of all reporting groups
213991|NCT01151215|B3|Baseline|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
213992|NCT01151215|B2|Baseline|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
213993|NCT01151215|B1|Baseline|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
213994|NCT01151215|P3|Participant Flow|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
213995|NCT01151215|P2|Participant Flow|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
213996|NCT01151215|P1|Participant Flow|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
213997|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
213998|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
213999|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
214000|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
214001|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
214002|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
214003|NCT01151215|E3|Reported Event|Placebo|
214004|NCT01151215|E2|Reported Event|AZD8931 40mg|
214005|NCT01151215|E1|Reported Event|AZD8931 20mg|
214006|NCT01151189|B3|Baseline|Total|Total of all reporting groups
214007|NCT01151189|B2|Baseline|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
214008|NCT01151189|B1|Baseline|Placebo|Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
214009|NCT01151189|P2|Participant Flow|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
214010|NCT01151189|P1|Participant Flow|Placebo|"The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.~Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo."
214011|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214012|NCT01151189|O1|Outcome|Placebo|
214013|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214014|NCT01151189|O1|Outcome|Placebo|
214015|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214016|NCT01151189|O1|Outcome|Placebo|
214017|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214018|NCT01151189|O1|Outcome|Placebo|
214019|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214020|NCT01151189|O1|Outcome|Placebo|
214021|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214022|NCT01151189|O1|Outcome|Placebo|
214023|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214024|NCT01151189|O1|Outcome|Placebo|
214025|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214026|NCT01151189|O1|Outcome|Placebo|
214027|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
214028|NCT01151189|O1|Outcome|Placebo|
214029|NCT01151189|E2|Reported Event|MVA85A/AERAS-485|
214030|NCT01151189|E1|Reported Event|Placebo|
214031|NCT01151137|B3|Baseline|Total|Total of all reporting groups
214032|NCT01151137|B2|Baseline|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214033|NCT01151137|B1|Baseline|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214034|NCT01151137|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214035|NCT01151137|P1|Participant Flow|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214036|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214037|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214038|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214039|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214040|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214041|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214042|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214043|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214044|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214045|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214120|NCT01150760|B3|Baseline|Total|Total of all reporting groups
214046|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214047|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214048|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214049|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214050|NCT01151137|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
214051|NCT01151137|E1|Reported Event|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
214052|NCT01151098|B1|Baseline|Extension Phase (BTDS 5, 10 or 20)|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
214053|NCT01151098|P1|Participant Flow|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
214054|NCT01151098|O1|Outcome|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
214055|NCT01151098|E1|Reported Event|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
214056|NCT01151085|B1|Baseline|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214057|NCT01151085|P1|Participant Flow|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214058|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
214059|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
214060|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
214061|NCT01151085|O2|Outcome|Without Past History|Participants without Past History who taking Voriconazole according to Japanese Package Insert.
214062|NCT01151085|O1|Outcome|With Past History|Participants with Past History who taking Voriconazole according to Japanese Package Insert.
214063|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
214064|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
214065|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
214066|NCT01151085|O2|Outcome|Female|Female Participants taking Voriconazole according to Japanese Package Insert.
214067|NCT01151085|O1|Outcome|Male|Male Participants taking Voriconazole according to Japanese Package Insert.
214068|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214069|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214070|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214071|NCT01151085|E1|Reported Event|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
214072|NCT01151046|B3|Baseline|Total|Total of all reporting groups
214073|NCT01151046|B2|Baseline|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214074|NCT01151046|B1|Baseline|MM-121 + Exemestane|MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214075|NCT01151046|P2|Participant Flow|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214076|NCT01151046|P1|Participant Flow|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214077|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214078|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214079|NCT01151046|O4|Outcome|HRG Low: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214080|NCT01151046|O3|Outcome|HRG Low: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214081|NCT01151046|O2|Outcome|HRG High: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214082|NCT01151046|O1|Outcome|HRG High: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214083|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214084|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214085|NCT01151046|E2|Reported Event|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
214086|NCT01151046|E1|Reported Event|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
214562|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214087|NCT01151020|B1|Baseline|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
214088|NCT01151020|P1|Participant Flow|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
214089|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
214090|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
214091|NCT01151020|E1|Reported Event|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
214092|NCT01150981|B3|Baseline|Total|Total of all reporting groups
214093|NCT01150981|B2|Baseline|Placebo|One capsule daily for 6 weeks.
214094|NCT01150981|B1|Baseline|Rosiglitazone|One 8mg capsule daily for 6 weeks.
214095|NCT01150981|P2|Participant Flow|Placebo|One capsule daily for 6 weeks.
214096|NCT01150981|P1|Participant Flow|Rosiglitazone|One 8mg capsule daily for 6 weeks.
214097|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
214098|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
214099|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
214100|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
214101|NCT01150981|E2|Reported Event|Placebo|One capsule daily for 6 weeks.
214102|NCT01150981|E1|Reported Event|Rosiglitazone|One 8mg capsule daily for 6 weeks.
214103|NCT01150903|B3|Baseline|Total|Total of all reporting groups
214104|NCT01150903|B2|Baseline|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
214105|NCT01150903|B1|Baseline|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214106|NCT01150903|P2|Participant Flow|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
214107|NCT01150903|P1|Participant Flow|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214108|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214109|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214110|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214111|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214112|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214113|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214114|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
214115|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214116|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
214117|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214118|NCT01150903|E2|Reported Event|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
214119|NCT01150903|E1|Reported Event|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
214121|NCT01150760|B2|Baseline|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214122|NCT01150760|B1|Baseline|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214123|NCT01150760|P2|Participant Flow|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214124|NCT01150760|P1|Participant Flow|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214125|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214126|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214127|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214128|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214129|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214130|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214131|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214132|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214133|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214134|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214135|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214136|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214137|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214138|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214139|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214140|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214141|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214142|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214143|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214144|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214145|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214146|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214147|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214148|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214149|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214150|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214151|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214152|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214153|NCT01150760|E2|Reported Event|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
214154|NCT01150760|E1|Reported Event|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
214155|NCT01150500|B1|Baseline|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214156|NCT01150500|P1|Participant Flow|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214157|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214158|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214159|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214160|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214161|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214162|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214163|NCT01150500|E1|Reported Event|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
214164|NCT01150474|B3|Baseline|Total|Total of all reporting groups
214165|NCT01150474|B2|Baseline|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214166|NCT01150474|B1|Baseline|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214167|NCT01150474|P2|Participant Flow|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214168|NCT01150474|P1|Participant Flow|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214169|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214170|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214171|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214172|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214173|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214174|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214175|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214176|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214177|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214178|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214179|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214180|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214181|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214182|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214183|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214184|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214185|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214186|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214187|NCT01150474|E2|Reported Event|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214188|NCT01150474|E1|Reported Event|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
214189|NCT01150461|B3|Baseline|Total|Total of all reporting groups
214190|NCT01150461|B2|Baseline|Placebo|
214191|NCT01150461|B1|Baseline|Losartan 50 mg PO BID|
214192|NCT01150461|P2|Participant Flow|Placebo|
214193|NCT01150461|P1|Participant Flow|Losartan 50 mg BID|
214194|NCT01150461|O2|Outcome|Placebo|
214195|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
214196|NCT01150461|O2|Outcome|Placebo|
214197|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
214198|NCT01150461|E2|Reported Event|Placebo|
214199|NCT01150461|E1|Reported Event|Losartan 50 PO mg BID|
214200|NCT01150409|B3|Baseline|Total|Total of all reporting groups
214201|NCT01150409|B2|Baseline|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214202|NCT01150409|B1|Baseline|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214203|NCT01150409|P2|Participant Flow|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214204|NCT01150409|P1|Participant Flow|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214205|NCT01150409|O2|Outcome|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214206|NCT01150409|O1|Outcome|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214207|NCT01150409|E2|Reported Event|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214208|NCT01150409|E1|Reported Event|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
214209|NCT01150357|B4|Baseline|Total|Total of all reporting groups
214210|NCT01150357|B3|Baseline|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214211|NCT01150357|B2|Baseline|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214232|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214212|NCT01150357|B1|Baseline|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
214213|NCT01150357|P3|Participant Flow|Aliskiren High (150/300/600 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment."
214214|NCT01150357|P2|Participant Flow|Aliskiren Mid (37.5/75/150 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.~During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment."
214215|NCT01150357|P1|Participant Flow|Aliskiren Low (6.25/12.5/25 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment."
214216|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214217|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214218|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214219|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214220|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214221|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214222|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214223|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214224|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214225|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214226|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214227|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214228|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214229|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214230|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214231|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
214233|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
214234|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214235|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
214236|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214237|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214238|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214239|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214240|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
214241|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214242|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
214243|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214244|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
214245|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214246|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214247|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214248|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214249|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
214250|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214251|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
214252|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214253|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
214254|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214255|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214256|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214257|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214258|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
214288|NCT01150097|B3|Baseline|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214563|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214259|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214260|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
214261|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214262|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
214263|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214264|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214265|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214266|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214267|NCT01150357|E9|Reported Event|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
214268|NCT01150357|E8|Reported Event|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
214269|NCT01150357|E7|Reported Event|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
214270|NCT01150357|E6|Reported Event|Phase 2: Aliskiren High (150/300/600 mg)|"Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and~≤ 150 kg received 600 mg of aliskiren."
214271|NCT01150357|E5|Reported Event|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214272|NCT01150357|E4|Reported Event|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214273|NCT01150357|E3|Reported Event|Phase 1: Aliskiren High (150/300/600 mg)|Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
214274|NCT01150357|E2|Reported Event|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
214275|NCT01150357|E1|Reported Event|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
214276|NCT01149148|B3|Baseline|Total|Total of all reporting groups
214277|NCT01149148|B2|Baseline|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
214278|NCT01149148|B1|Baseline|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
214279|NCT01149148|P2|Participant Flow|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
214280|NCT01149148|P1|Participant Flow|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
214281|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
214282|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
214283|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
214284|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
214285|NCT01149148|E2|Reported Event|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
214286|NCT01149148|E1|Reported Event|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
214287|NCT01150097|B4|Baseline|Total|Total of all reporting groups
214713|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214289|NCT01150097|B2|Baseline|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214290|NCT01150097|B1|Baseline|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214291|NCT01150097|P3|Participant Flow|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214292|NCT01150097|P2|Participant Flow|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214293|NCT01150097|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214294|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214295|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214296|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214297|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214298|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214299|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214300|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214301|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214302|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214303|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214304|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214305|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214306|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214307|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
214308|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
214309|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
214310|NCT01150097|E5|Reported Event|TAC Elimination, Month 48|TAC Elimination, Month 48
214311|NCT01150097|E4|Reported Event|Reduced RAD + TAC, Month 48|Reduced RAD + TAC, Month 48
214312|NCT01150097|E3|Reported Event|TAC Control, Month 36|TAC Control, Month 36
214313|NCT01150097|E2|Reported Event|TAC Elimination, Month 36|TAC Elimination, Month 36
214314|NCT01150097|E1|Reported Event|Reduced TAC, Month 36|Reduced TAC, Month 36
214315|NCT01149876|B5|Baseline|Total|Total of all reporting groups
214316|NCT01149876|B4|Baseline|Proprietary Topical Plus Iontophoresis|
214317|NCT01149876|B3|Baseline|Tretinoin|
214318|NCT01149876|B2|Baseline|Placebo|
214319|NCT01149876|B1|Baseline|Proprietary Topical|
214320|NCT01149876|P4|Participant Flow|Nu Skin Product With Galvanic Spa System|
214321|NCT01149876|P3|Participant Flow|Tretinoin Cream 0.05|
214322|NCT01149876|P2|Participant Flow|Over the Counter Moisturizer|CeraVe Moisturizer
214323|NCT01149876|P1|Participant Flow|Nu Skin Product|
214324|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
214325|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
214326|NCT01149876|O2|Outcome|Over the Counter Moisturizer|
214327|NCT01149876|O1|Outcome|Nu Skin Product|
214328|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
214329|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
214330|NCT01149876|O2|Outcome|Over the Counter Moisturizer|CeraVe cream
214331|NCT01149876|O1|Outcome|Nu Skin Product|
214332|NCT01149876|E4|Reported Event|Proprietary Topical Plus Iontophoresis|
214333|NCT01149876|E3|Reported Event|Tretinoin|
214334|NCT01149876|E2|Reported Event|Placebo|
214335|NCT01149876|E1|Reported Event|Proprietary Topical|
214336|NCT01149863|B1|Baseline|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
214337|NCT01149863|P1|Participant Flow|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
214338|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
214339|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
214340|NCT01149863|E1|Reported Event|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
214341|NCT01149785|B1|Baseline|Entire Study Population|Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
214714|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214342|NCT01149785|P2|Participant Flow|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
214343|NCT01149785|P1|Participant Flow|Crizotinib 150 mg|Single oral dose of crizotinib 150 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
214344|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214345|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214346|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214347|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214348|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214349|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214350|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214351|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214352|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214353|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214354|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214355|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214356|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214357|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214358|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214359|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214360|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214361|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214362|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214363|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214364|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214365|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214366|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214367|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214368|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214369|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214370|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214371|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214372|NCT01149785|E2|Reported Event|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
214373|NCT01149785|E1|Reported Event|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
214374|NCT01149772|B3|Baseline|Total|Total of all reporting groups
214375|NCT01149772|B2|Baseline|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214504|NCT01149460|P1|Participant Flow|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214376|NCT01149772|B1|Baseline|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
214377|NCT01149772|P2|Participant Flow|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214378|NCT01149772|P1|Participant Flow|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
214379|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
214380|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
214381|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214382|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
214383|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214384|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
214385|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214386|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
214387|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
214388|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
214389|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
225983|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
214390|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
214391|NCT01149772|E2|Reported Event|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
214392|NCT01149772|E1|Reported Event|ACCESS|ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
214393|NCT01149733|B3|Baseline|Total|Total of all reporting groups
214394|NCT01149733|B2|Baseline|Flomax®|0.4 mg Capsule
214395|NCT01149733|B1|Baseline|Tamsulosin|0.4 mg Capsule
214396|NCT01149733|P2|Participant Flow|Flomax®|0.4 mg Capsule
214397|NCT01149733|P1|Participant Flow|Tamsulosin|0.4 mg Capsule
214398|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
214399|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
214400|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
214401|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
214402|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
214403|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
214404|NCT01149733|E2|Reported Event|Flomax®|0.4 mg Capsule
214405|NCT01149733|E1|Reported Event|Tamsulosin|0.4 mg Capsule
214406|NCT01149655|B3|Baseline|Total|Total of all reporting groups
214407|NCT01149655|B2|Baseline|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214408|NCT01149655|B1|Baseline|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214409|NCT01149655|P4|Participant Flow|Aripiprazole-Placebo-DB Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
214410|NCT01149655|P3|Participant Flow|Aripiprazole-Double Blind (DB) Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
214411|NCT01149655|P2|Participant Flow|Aripiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
214412|NCT01149655|P1|Participant Flow|Aripiprazole-Conversion Phase|Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
214413|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214414|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214415|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214416|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214417|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214418|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214419|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214420|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214421|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214422|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214423|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214503|NCT01149460|P2|Participant Flow|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214424|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214425|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214426|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214427|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214428|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214429|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214430|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214431|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214432|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214433|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
214434|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
214435|NCT01149655|E4|Reported Event|Placebo-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
214436|NCT01149655|E3|Reported Event|Aripiprazole-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
214437|NCT01149655|E2|Reported Event|Arpiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
214438|NCT01149655|E1|Reported Event|Aripiprazole-Conversion Phase|Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
214439|NCT01149538|B3|Baseline|Total|Total of all reporting groups
214440|NCT01149538|B2|Baseline|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214441|NCT01149538|B1|Baseline|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214442|NCT01149538|P2|Participant Flow|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214443|NCT01149538|P1|Participant Flow|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214444|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214445|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214446|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214447|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214448|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214449|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214450|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214451|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214452|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214453|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214454|NCT01149538|E2|Reported Event|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
214455|NCT01149538|E1|Reported Event|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
214456|NCT01149486|B3|Baseline|Total|Total of all reporting groups
214457|NCT01149486|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
214458|NCT01149486|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
214459|NCT01149486|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
214460|NCT01149486|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
214461|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214462|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214463|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214464|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214465|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214466|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214467|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214468|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214469|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214470|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214471|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214472|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214473|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214474|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214475|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214476|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214477|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214478|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214479|NCT01149486|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214480|NCT01149486|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
214481|NCT01149473|B3|Baseline|Total|Total of all reporting groups
214482|NCT01149473|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
214483|NCT01149473|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
214484|NCT01149473|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
214485|NCT01149473|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
214486|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214487|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214488|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214489|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214490|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214491|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214492|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214493|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214494|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214495|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214496|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214497|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214498|NCT01149473|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
214499|NCT01149473|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
214500|NCT01149460|B3|Baseline|Total|Total of all reporting groups
214501|NCT01149460|B2|Baseline|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214502|NCT01149460|B1|Baseline|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214505|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214506|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214507|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214508|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214509|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214510|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214511|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214512|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214513|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214514|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214515|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214516|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214517|NCT01149460|E2|Reported Event|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
214518|NCT01149460|E1|Reported Event|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
214519|NCT01149434|B3|Baseline|Total|Total of all reporting groups
214520|NCT01149434|B2|Baseline|Pharmacokinetic Arm-Phase II|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214521|NCT01149434|B1|Baseline|Pharmacokinetic Arm - Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus."
214522|NCT01149434|P2|Participant Flow|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214523|NCT01149434|P1|Participant Flow|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214524|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214525|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214526|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214527|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214560|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214561|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214528|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214529|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214530|NCT01149434|O1|Outcome|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214531|NCT01149434|E2|Reported Event|Pharmacodynamic Arm|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
214532|NCT01149434|E1|Reported Event|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
214533|NCT01149421|B4|Baseline|Total|Total of all reporting groups
214534|NCT01149421|B3|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214535|NCT01149421|B2|Baseline|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214536|NCT01149421|B1|Baseline|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214537|NCT01149421|P3|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214538|NCT01149421|P2|Participant Flow|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214539|NCT01149421|P1|Participant Flow|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214540|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214541|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214542|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214543|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214544|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214545|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214546|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214547|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214548|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214549|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214550|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214551|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214552|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214553|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214554|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214555|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214556|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214557|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214558|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214559|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214564|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214565|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214566|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214567|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214568|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214569|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214570|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214571|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214572|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214573|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214574|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214575|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214576|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214577|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214578|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214579|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214580|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214581|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214582|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214583|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214584|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214585|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214586|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214587|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214588|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214589|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214590|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214591|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214592|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214593|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214594|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214595|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214596|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214597|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214598|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214599|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214600|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214601|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214602|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214603|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214604|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214605|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214606|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214607|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214608|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214609|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214610|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214611|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214612|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214613|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214614|NCT01149421|E3|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
214615|NCT01149421|E2|Reported Event|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214715|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214616|NCT01149421|E1|Reported Event|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
214617|NCT01149057|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214618|NCT01149057|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.
214619|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214620|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214621|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214622|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214623|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214624|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214625|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214626|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214627|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214628|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214629|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214630|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214631|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214632|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214633|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214634|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214635|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214636|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214637|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214638|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214639|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214640|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214641|NCT01149057|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
214642|NCT01148836|B3|Baseline|Total|Total of all reporting groups
214643|NCT01148836|B2|Baseline|Pulmonary Hypertension Subjects|
214644|NCT01148836|B1|Baseline|Healthy Controls Subjects|
214645|NCT01148836|P2|Participant Flow|Pulmonary Hypertension Subjects (Disease)|
214646|NCT01148836|P1|Participant Flow|Healthy Controls|
214647|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
214648|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214649|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
214650|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214651|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
214652|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214653|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
214654|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214655|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
214656|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214657|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214658|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214659|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214660|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214661|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
214662|NCT01148836|E2|Reported Event|Coenzyme Q and Healthy Controls|Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
214663|NCT01148836|E1|Reported Event|Coenzyme Q and Pulmonary Hypertension|Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
214664|NCT01148771|B3|Baseline|Total|Total of all reporting groups
214665|NCT01148771|B2|Baseline|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
214666|NCT01148771|B1|Baseline|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
214716|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214667|NCT01148771|P2|Participant Flow|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
214668|NCT01148771|P1|Participant Flow|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
214669|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
214670|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
214671|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 30 minute IV infusion.
214672|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 5 minute IV bolus.
214673|NCT01148771|O2|Outcome|Ertapenem IV 30 Minute Infusion|
214674|NCT01148771|O1|Outcome|Ertapenem IV 5 Minute Bolus|
214675|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
214676|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
214677|NCT01148771|E2|Reported Event|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
214678|NCT01148771|E1|Reported Event|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
214679|NCT01148745|B1|Baseline|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
214680|NCT01148745|P1|Participant Flow|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
214681|NCT01148745|O1|Outcome|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
214682|NCT01148745|O1|Outcome|Ferumoxytol 510 mg|2 doses of 510 mg IV over 17 seconds separated by 3 days
214683|NCT01148745|O1|Outcome|Ferumoxytol|All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
214684|NCT01148745|E1|Reported Event|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
214685|NCT01148693|B3|Baseline|Total|Total of all reporting groups
214686|NCT01148693|B2|Baseline|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214687|NCT01148693|B1|Baseline|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214688|NCT01148693|P2|Participant Flow|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214689|NCT01148693|P1|Participant Flow|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214690|NCT01148693|O2|Outcome|Placebo|patients for whom distilled water is added to contrast during ERCP
214691|NCT01148693|O1|Outcome|Gentamicin|patients for whom 10m/10cc of gentamicin is added to contrast during ERCP
214692|NCT01148693|E2|Reported Event|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214693|NCT01148693|E1|Reported Event|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
214694|NCT01148537|B4|Baseline|Total|Total of all reporting groups
214695|NCT01148537|B3|Baseline|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
214696|NCT01148537|B2|Baseline|Placebo|Matching placebo transdermal patches.
214697|NCT01148537|B1|Baseline|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214698|NCT01148537|P3|Participant Flow|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
214699|NCT01148537|P2|Participant Flow|Placebo|Matching placebo transdermal patches.
214700|NCT01148537|P1|Participant Flow|BTDS|"Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.~BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin."
214701|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214702|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
214703|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214704|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214705|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214706|NCT01148537|O1|Outcome|Mofloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
214707|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214708|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214709|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214710|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
214711|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
214712|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
214717|NCT01148537|E3|Reported Event|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
214718|NCT01148537|E2|Reported Event|Placebo|Matching placebo transdermal patches.
214719|NCT01148537|E1|Reported Event|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
214720|NCT01148524|B10|Baseline|Total|Total of all reporting groups
214721|NCT01148524|B9|Baseline|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214722|NCT01148524|B8|Baseline|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214723|NCT01148524|B7|Baseline|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214724|NCT01148524|B6|Baseline|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214725|NCT01148524|B5|Baseline|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214726|NCT01148524|B4|Baseline|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214727|NCT01148524|B3|Baseline|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214728|NCT01148524|B2|Baseline|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214729|NCT01148524|B1|Baseline|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214730|NCT01148524|P9|Participant Flow|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214731|NCT01148524|P8|Participant Flow|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214732|NCT01148524|P7|Participant Flow|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214733|NCT01148524|P6|Participant Flow|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214734|NCT01148524|P5|Participant Flow|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214735|NCT01148524|P4|Participant Flow|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214736|NCT01148524|P3|Participant Flow|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214737|NCT01148524|P2|Participant Flow|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214738|NCT01148524|P1|Participant Flow|rMenB06|Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214739|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214740|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214741|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214742|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214743|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214744|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214745|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214746|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214747|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214748|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214749|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214750|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214751|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214752|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214753|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214754|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214755|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214756|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214757|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214758|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214759|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214760|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214761|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214762|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214763|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214764|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214765|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214766|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214767|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214768|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214769|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214770|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214771|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214772|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214773|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214774|NCT01148524|E9|Reported Event|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
214775|NCT01148524|E8|Reported Event|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
214776|NCT01148524|E7|Reported Event|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
214777|NCT01148524|E6|Reported Event|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
214778|NCT01148524|E5|Reported Event|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
214779|NCT01148524|E4|Reported Event|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
214780|NCT01148524|E3|Reported Event|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
214781|NCT01148524|E2|Reported Event|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
214782|NCT01148524|E1|Reported Event|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
214783|NCT01148511|B3|Baseline|Total|Total of all reporting groups
214784|NCT01148511|B2|Baseline|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214785|NCT01148511|B1|Baseline|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214786|NCT01148511|P3|Participant Flow|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214787|NCT01148511|P2|Participant Flow|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214788|NCT01148511|P1|Participant Flow|All Patients|All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
214789|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214790|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214791|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214815|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
215925|NCT01144624|E1|Reported Event|Dose Cohort 1|AZD9773 250/50 units/kg IV
214792|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214793|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214794|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214795|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214796|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214797|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214798|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214799|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214800|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214801|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214802|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214803|NCT01148511|E3|Reported Event|Before Randomization|These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
214804|NCT01148511|E2|Reported Event|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
214805|NCT01148511|E1|Reported Event|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
214806|NCT01148420|B1|Baseline|DMPA + MPA|
214807|NCT01148420|P1|Participant Flow|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
214808|NCT01148420|O1|Outcome|DMPA + MPA|
214809|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
214810|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
214811|NCT01148420|E1|Reported Event|DMPA & High Dose MPA|DMPA & High Dose MPA
214812|NCT01148056|B1|Baseline|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214813|NCT01148056|P1|Participant Flow|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214814|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214885|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214816|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214817|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214818|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214819|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214820|NCT01148056|E1|Reported Event|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
214821|NCT01148017|B5|Baseline|Total|Total of all reporting groups
214822|NCT01148017|B4|Baseline|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214823|NCT01148017|B3|Baseline|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214824|NCT01148017|B2|Baseline|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214825|NCT01148017|B1|Baseline|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214826|NCT01148017|P4|Participant Flow|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214827|NCT01148017|P3|Participant Flow|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214828|NCT01148017|P2|Participant Flow|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214829|NCT01148017|P1|Participant Flow|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214830|NCT01148017|O4|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214831|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214832|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214833|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214834|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214835|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214836|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214837|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214838|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214839|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214840|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214841|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214842|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214843|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214844|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214845|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214846|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214847|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214848|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
215450|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
214849|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214850|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214851|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214852|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214853|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214854|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214855|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214856|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214857|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214858|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214859|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214860|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214861|NCT01148017|E4|Reported Event|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
214862|NCT01148017|E3|Reported Event|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
214863|NCT01148017|E2|Reported Event|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
214864|NCT01148017|E1|Reported Event|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
214865|NCT01147926|B3|Baseline|Total|Total of all reporting groups
214866|NCT01147926|B2|Baseline|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214867|NCT01147926|B1|Baseline|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214868|NCT01147926|P2|Participant Flow|PRUCALOPRIDE|Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214869|NCT01147926|P1|Participant Flow|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214870|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214871|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214872|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214873|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214874|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214875|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214876|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214877|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214878|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214879|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214880|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214881|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214882|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214883|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214884|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214886|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214887|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214888|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214889|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214890|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214891|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214892|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214893|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214894|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214895|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214896|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214897|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214898|NCT01147926|E2|Reported Event|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to less than <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
214899|NCT01147926|E1|Reported Event|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
214900|NCT01147900|B4|Baseline|Total|Total of all reporting groups
214901|NCT01147900|B3|Baseline|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214902|NCT01147900|B2|Baseline|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214903|NCT01147900|B1|Baseline|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214904|NCT01147900|P3|Participant Flow|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214905|NCT01147900|P2|Participant Flow|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214906|NCT01147900|P1|Participant Flow|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214989|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214990|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214907|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214908|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214909|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214910|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214911|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214912|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214913|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214914|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214915|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214916|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214917|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
225984|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
214918|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214919|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214920|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214921|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214922|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214923|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214924|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214925|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214926|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214927|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214928|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214929|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214930|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214931|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214932|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214933|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214934|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214935|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214936|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214937|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214938|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214939|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214940|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214941|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214942|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214943|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214944|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214945|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214946|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214947|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214948|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214949|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214950|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
225985|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
214951|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214952|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214953|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214954|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214955|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214956|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214957|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214958|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214959|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214960|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214961|NCT01147900|E3|Reported Event|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214962|NCT01147900|E2|Reported Event|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214963|NCT01147900|E1|Reported Event|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
214964|NCT01147874|B1|Baseline|All Participants|Participants with psoriasis were observed for 8 weeks.
214965|NCT01147874|P1|Participant Flow|All Participants|Participants with psoriasis were observed for 8 weeks.
214966|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
214967|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
214968|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
214969|NCT01147874|E1|Reported Event|All Participants|Participants with psoriasis were observed for 8 weeks.
214970|NCT01147848|B3|Baseline|Total|Total of all reporting groups
214971|NCT01147848|B2|Baseline|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214972|NCT01147848|B1|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214973|NCT01147848|P3|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214974|NCT01147848|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214975|NCT01147848|P1|Participant Flow|Fluticasone Propionate 250 µg BID|Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
214976|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214977|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214978|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214979|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214980|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214981|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214982|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214983|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214984|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214985|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214986|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214987|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214988|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
215811|NCT01144299|E2|Reported Event|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
214991|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214992|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214993|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214994|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214995|NCT01147848|O1|Outcome|FFluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214996|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214997|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
214998|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
214999|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
215000|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
215001|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
215002|NCT01147848|E2|Reported Event|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
215003|NCT01147848|E1|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
215004|NCT01147822|B3|Baseline|Total|Total of all reporting groups
215005|NCT01147822|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215006|NCT01147822|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215007|NCT01147822|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215008|NCT01147822|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215009|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215010|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215011|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215012|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215013|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215099|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215014|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215015|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215016|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215017|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215018|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215019|NCT01147822|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215020|NCT01147822|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
215021|NCT01147809|B7|Baseline|Total|Total of all reporting groups
215022|NCT01147809|B6|Baseline|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215023|NCT01147809|B5|Baseline|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215024|NCT01147809|B4|Baseline|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215025|NCT01147809|B3|Baseline|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215026|NCT01147809|B2|Baseline|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215027|NCT01147809|B1|Baseline|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215028|NCT01147809|P6|Participant Flow|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215029|NCT01147809|P5|Participant Flow|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215030|NCT01147809|P4|Participant Flow|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215031|NCT01147809|P3|Participant Flow|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215032|NCT01147809|P2|Participant Flow|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215033|NCT01147809|P1|Participant Flow|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215034|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215035|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215036|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215037|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215038|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215039|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215040|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215041|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215042|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215043|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215044|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215045|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215046|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215047|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215048|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215049|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215050|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215051|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215052|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215053|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215054|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215055|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
225986|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
215056|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215057|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215058|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215059|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215060|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215061|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215062|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215063|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215064|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215065|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215066|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215067|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215068|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215069|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215070|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215071|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215072|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215073|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215074|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215075|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215076|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215812|NCT01144299|E1|Reported Event|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215077|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215078|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215079|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215080|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215081|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215082|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215083|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215084|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215085|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215086|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215087|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215088|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215089|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215090|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215091|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215092|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215093|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215094|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215095|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215096|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215097|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215098|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215100|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg)|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215101|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215102|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215103|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215104|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215105|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215106|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215107|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215108|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215109|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215110|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215111|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215112|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215113|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215114|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215115|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215116|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215117|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215118|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215119|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215120|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215121|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215122|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215123|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215124|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215125|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215126|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215127|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215128|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215129|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215130|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215131|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215132|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215133|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215134|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215135|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215136|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215137|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215138|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215139|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215140|NCT01147809|E6|Reported Event|Phase II: Eltrombopag|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215141|NCT01147809|E5|Reported Event|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
215142|NCT01147809|E4|Reported Event|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215215|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215143|NCT01147809|E3|Reported Event|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215144|NCT01147809|E2|Reported Event|Phase I: 21-Day Cycle Eltrombopag|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215145|NCT01147809|E1|Reported Event|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
215146|NCT01147640|B3|Baseline|Total|Total of all reporting groups
215147|NCT01147640|B2|Baseline|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
215148|NCT01147640|B1|Baseline|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
215149|NCT01147640|P2|Participant Flow|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
215150|NCT01147640|P1|Participant Flow|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
215151|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
215152|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
215153|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
215154|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
215155|NCT01147640|E2|Reported Event|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
215156|NCT01147640|E1|Reported Event|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
215157|NCT01147627|B4|Baseline|Total|Total of all reporting groups
215158|NCT01147627|B3|Baseline|Thiazolidinedione|
215159|NCT01147627|B2|Baseline|Premixed Insulin Analog|
215160|NCT01147627|B1|Baseline|Exenatide|
215161|NCT01147627|P3|Participant Flow|Pioglitazone|Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
215162|NCT01147627|P2|Participant Flow|Premixed Insulin Analog|Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
215163|NCT01147627|P1|Participant Flow|Exenatide|5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
215164|NCT01147627|O3|Outcome|Thiazolidinedione|
215165|NCT01147627|O2|Outcome|Premixed Insulin Analog|
215166|NCT01147627|O1|Outcome|Exenatide|
215167|NCT01147627|E3|Reported Event|Thiazolidinedione|
215168|NCT01147627|E2|Reported Event|Premixed Insulin Analog|
215169|NCT01147627|E1|Reported Event|Exenatide|
215170|NCT01147497|B3|Baseline|Total|Total of all reporting groups
215171|NCT01147497|B2|Baseline|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215172|NCT01147497|B1|Baseline|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215173|NCT01147497|P2|Participant Flow|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215174|NCT01147497|P1|Participant Flow|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215175|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215176|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215177|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215178|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215179|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215180|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215181|NCT01147497|E2|Reported Event|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
215182|NCT01147497|E1|Reported Event|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
215183|NCT01147471|B3|Baseline|Total|Total of all reporting groups
215184|NCT01147471|B2|Baseline|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215295|NCT01147341|B1|Baseline|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215185|NCT01147471|B1|Baseline|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215186|NCT01147471|P2|Participant Flow|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215187|NCT01147471|P1|Participant Flow|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215188|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215189|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215190|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215191|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215192|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215193|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215194|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215813|NCT01144286|B5|Baseline|Total|Total of all reporting groups
225987|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
215195|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215196|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215197|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
215198|NCT01147471|E2|Reported Event|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
215199|NCT01147471|E1|Reported Event|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize stove-in segment. Post-operatively, the patients would receive standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.~operative rib fix"
215200|NCT01147458|B1|Baseline|Entire Study Population|Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.
215201|NCT01147458|P4|Participant Flow|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215202|NCT01147458|P3|Participant Flow|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215203|NCT01147458|P2|Participant Flow|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215204|NCT01147458|P1|Participant Flow|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215205|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215206|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215207|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215208|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215209|NCT01147458|O2|Outcome|PF-04191834 600 mg BID + Naproxen 500 mg BID|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
215210|NCT01147458|O1|Outcome|PF-04191834 600 mg BID|PF-04191834 600 mg BID administered either in Period 1 or Period 2
215211|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215212|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215213|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215214|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215216|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215217|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215218|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215219|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215220|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215221|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215222|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215223|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215224|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215225|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215226|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215227|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215228|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215229|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215230|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215231|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215232|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215233|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215234|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215235|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215236|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215237|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215238|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215239|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215240|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215241|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215242|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215243|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
215244|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
215296|NCT01147341|P2|Participant Flow|Placebo|"Reporting group: Placebo : prefilled saline syringe during the Double Blind Period~10 patients entered"
215245|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
215246|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
215247|NCT01147458|E4|Reported Event|Naproxen|Naproxen 500 mg BID administered either in Period 1 or Period 2
215248|NCT01147458|E3|Reported Event|PF-04191834 + Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
215249|NCT01147458|E2|Reported Event|Placebo|Placebo administered either in Period 1 or Period 2
215250|NCT01147458|E1|Reported Event|PF-04191834|PF-04191834 600 mg BID administered either in Period 1 or Period 2
215251|NCT01147406|B7|Baseline|Total|Total of all reporting groups
215252|NCT01147406|B6|Baseline|Placebo|Not Active - Placebo
215253|NCT01147406|B5|Baseline|Cohort 6|N6022 - Active 35 mg
215254|NCT01147406|B4|Baseline|Cohort 5|N6022 - Active 25 mg
215255|NCT01147406|B3|Baseline|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
215256|NCT01147406|B2|Baseline|Cohort 2 & 4|N6022 - Active 15 mg
215257|NCT01147406|B1|Baseline|Cohort 1|N6022 - Active 5 mg
215258|NCT01147406|P6|Participant Flow|Placebo|Not Active - Placebo
215259|NCT01147406|P5|Participant Flow|Cohort 6|35 mg of N6022 was given intravenously daily for 7 days
215260|NCT01147406|P4|Participant Flow|Cohort 5|25 mg of N6022 was given intravenously daily for 7 days
215261|NCT01147406|P3|Participant Flow|Cohort 3|45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
215262|NCT01147406|P2|Participant Flow|Cohorts 2 and 4|15 mg of N6022 was given intravenously daily for 7 days
215263|NCT01147406|P1|Participant Flow|Cohort 1|5 mg of N6022 was given intravenously daily for 7 days
215264|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
215265|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
215266|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
215267|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
215268|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
215269|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
215270|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
215271|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
215272|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
215273|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg
215274|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
215275|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
215276|NCT01147406|E6|Reported Event|Placebo|Not Active - Placebo
215277|NCT01147406|E5|Reported Event|Cohort 6|N6022 - Active 35 mg
215278|NCT01147406|E4|Reported Event|Cohort 5|N6022 - Active 25 mg
215279|NCT01147406|E3|Reported Event|Cohort 3|N6022 - Active 45 mg
215280|NCT01147406|E2|Reported Event|Cohort 2 and 4|N6022 - Active 15 mg
215281|NCT01147406|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
215282|NCT01147380|B3|Baseline|Total|Total of all reporting groups
215283|NCT01147380|B2|Baseline|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215284|NCT01147380|B1|Baseline|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215285|NCT01147380|P2|Participant Flow|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
215286|NCT01147380|P1|Participant Flow|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
215287|NCT01147380|O2|Outcome|Large Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215288|NCT01147380|O1|Outcome|Small Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215289|NCT01147380|O2|Outcome|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215290|NCT01147380|O1|Outcome|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215291|NCT01147380|E2|Reported Event|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215292|NCT01147380|E1|Reported Event|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
215293|NCT01147341|B3|Baseline|Total|Total of all reporting groups
215294|NCT01147341|B2|Baseline|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215297|NCT01147341|P1|Participant Flow|Active Treatment With Cimzia|"Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.~Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.~27 patients entered the Double Blind Portion."
215298|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215299|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215300|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215301|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215302|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215303|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215304|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215305|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215306|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215307|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215308|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215309|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215310|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215311|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215312|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215313|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215314|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215315|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215316|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215317|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215318|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215319|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215320|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215321|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215322|NCT01147341|E2|Reported Event|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
215323|NCT01147341|E1|Reported Event|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
215324|NCT01147302|B3|Baseline|Total|Total of all reporting groups
215325|NCT01147302|B2|Baseline|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215326|NCT01147302|B1|Baseline|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215327|NCT01147302|P2|Participant Flow|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215328|NCT01147302|P1|Participant Flow|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215329|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215330|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215331|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215332|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215333|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215334|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215357|NCT01147250|B3|Baseline|Total|Total of all reporting groups
225988|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
215335|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215336|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215337|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215338|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215339|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215340|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215341|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215342|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215343|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215344|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215345|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215346|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215347|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215348|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215349|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215350|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215351|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215352|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215353|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215354|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215355|NCT01147302|E2|Reported Event|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
215356|NCT01147302|E1|Reported Event|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
215358|NCT01147250|B2|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215359|NCT01147250|B1|Baseline|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
215360|NCT01147250|P2|Participant Flow|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215361|NCT01147250|P1|Participant Flow|Placebo|Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
215362|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215363|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
215364|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215365|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
215366|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215367|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
215368|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
215369|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
215370|NCT01147250|E2|Reported Event|Lixisenatide|Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
215371|NCT01147250|E1|Reported Event|Placebo|Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)
215372|NCT01147172|B1|Baseline|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
215373|NCT01147172|P1|Participant Flow|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
215374|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
215375|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
215376|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
215377|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
215378|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation at End of Study.
215379|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
215380|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
215381|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
215382|NCT01147172|E1|Reported Event|Safety Population|All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
215383|NCT01147068|B8|Baseline|Total|Total of all reporting groups
215384|NCT01147068|B7|Baseline|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215385|NCT01147068|B6|Baseline|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215386|NCT01147068|B5|Baseline|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215387|NCT01147068|B4|Baseline|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215388|NCT01147068|B3|Baseline|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215389|NCT01147068|B2|Baseline|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215390|NCT01147068|B1|Baseline|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215391|NCT01147068|P7|Participant Flow|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215392|NCT01147068|P6|Participant Flow|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215814|NCT01144286|B4|Baseline|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
215393|NCT01147068|P5|Participant Flow|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215394|NCT01147068|P4|Participant Flow|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215395|NCT01147068|P3|Participant Flow|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215396|NCT01147068|P2|Participant Flow|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215397|NCT01147068|P1|Participant Flow|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215398|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215399|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215400|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215401|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215402|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215403|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215404|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215405|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215406|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215407|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215408|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215409|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215410|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215411|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215412|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215413|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215414|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215415|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215416|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215417|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215418|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215419|NCT01147068|E7|Reported Event|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215420|NCT01147068|E6|Reported Event|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215421|NCT01147068|E5|Reported Event|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215422|NCT01147068|E4|Reported Event|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215423|NCT01147068|E3|Reported Event|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215424|NCT01147068|E2|Reported Event|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215425|NCT01147068|E1|Reported Event|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
215426|NCT01147055|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
215427|NCT01147055|P2|Participant Flow|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
215428|NCT01147055|P1|Participant Flow|Crizotinib 250 mg|Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
215429|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215430|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215431|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215432|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215433|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215434|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215435|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215436|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215437|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215438|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215439|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215440|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215441|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215442|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215443|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215444|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215445|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215446|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215447|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215448|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215449|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215918|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
215451|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215452|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215453|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215454|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215455|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215456|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215457|NCT01147055|E2|Reported Event|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
215458|NCT01147055|E1|Reported Event|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
215459|NCT01146951|B3|Baseline|Total|Total of all reporting groups
215460|NCT01146951|B2|Baseline|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215461|NCT01146951|B1|Baseline|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215462|NCT01146951|P2|Participant Flow|Placebo|Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215463|NCT01146951|P1|Participant Flow|Rufinamide (E2080)|"Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.~Target maintenance dose:~15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
215464|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215465|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215466|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215467|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215468|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215469|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215470|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215471|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215472|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215681|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
215473|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215474|NCT01146951|E2|Reported Event|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
215475|NCT01146951|E1|Reported Event|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
215476|NCT01146912|B8|Baseline|Total|Total of all reporting groups
215477|NCT01146912|B7|Baseline|Delayed Pediatrics: Usual Care|
215478|NCT01146912|B6|Baseline|Delayed Pediatrics: Conventional Text Message|
215479|NCT01146912|B5|Baseline|Delayed Pediatrics: Interactive Text Message|
215480|NCT01146912|B4|Baseline|Pregnant Women: Usual Care|
215481|NCT01146912|B3|Baseline|Pregnant Women: Text Message|
215482|NCT01146912|B2|Baseline|Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
215483|NCT01146912|B1|Baseline|Text Message Vaccine Reminders/Automated Telephone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
215484|NCT01146912|P8|Participant Flow|Parents|Included in enrollment but not in outcomes which are on child level
215485|NCT01146912|P7|Participant Flow|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
215486|NCT01146912|P6|Participant Flow|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
215487|NCT01146912|P5|Participant Flow|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
215488|NCT01146912|P4|Participant Flow|Pregnant Women: Usual Care|Received usual care
215489|NCT01146912|P3|Participant Flow|Pregnant Women: Text Message|Received text message reminders
215490|NCT01146912|P2|Participant Flow|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
215491|NCT01146912|P1|Participant Flow|Pediatric Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
215492|NCT01146912|O3|Outcome|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
215493|NCT01146912|O2|Outcome|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
215494|NCT01146912|O1|Outcome|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
215495|NCT01146912|O2|Outcome|Pregnant Women: Usual Care|
215496|NCT01146912|O1|Outcome|Pregnant Women: Text Message|
215497|NCT01146912|O2|Outcome|Automated Phone Call From Clinic|"Receipt of automated phone call from clinic~automated call: Automated call"
215498|NCT01146912|O1|Outcome|Text Message Vaccine Reminders|"Receipt of text message vaccine reminders~Text Message: Text message vaccine reminders~automated call: Automated call"
215499|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
215500|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
215501|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
215502|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
215503|NCT01146912|E7|Reported Event|Delayed Pediatric: Usual Care|
215504|NCT01146912|E6|Reported Event|Delayed Pediatric: Conventional Text Message|
215505|NCT01146912|E5|Reported Event|Delayed Pediatric: Interactive Text Message|
215506|NCT01146912|E4|Reported Event|Pregnant Women: Usual Care|
215507|NCT01146912|E3|Reported Event|Pregnant Women: Text Message|
215508|NCT01146912|E2|Reported Event|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
215509|NCT01146912|E1|Reported Event|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
215510|NCT01146873|B3|Baseline|Total|Total of all reporting groups
215511|NCT01146873|B2|Baseline|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
215512|NCT01146873|B1|Baseline|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
215682|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
215919|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
215513|NCT01146873|P2|Participant Flow|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
215514|NCT01146873|P1|Participant Flow|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
215515|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
215516|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
215517|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
215518|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
215519|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
215520|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
215521|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
215522|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
215523|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
215524|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
215525|NCT01146873|E2|Reported Event|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
215526|NCT01146873|E1|Reported Event|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
215527|NCT01146860|B3|Baseline|Total|Total of all reporting groups
215528|NCT01146860|B2|Baseline|Placebo|sugar coated tablets
215529|NCT01146860|B1|Baseline|BNO 1016|sugar coated tablets
215530|NCT01146860|P2|Participant Flow|Placebo|sugar coated tablets of identical appearance to active treatment
215531|NCT01146860|P1|Participant Flow|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
215532|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
215533|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
215534|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
215535|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
215536|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
215537|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
215538|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
215539|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
215540|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
215541|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
215542|NCT01146860|E2|Reported Event|Placebo|sugar coated tablets
215543|NCT01146860|E1|Reported Event|BNO 1016|sugar coated tablets
215544|NCT01146782|B1|Baseline|Safety Cohort|Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
215545|NCT01146782|P1|Participant Flow|Sleep Apnea Treatment (Primary Endpoint Cohort)|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
215546|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
215547|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
215548|NCT01146782|O1|Outcome|Safety Cohort|The Safety Cohort is comprised of all subjects with at least one night of Winx therapy usage.
215549|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
215550|NCT01146782|E1|Reported Event|Safety Cohort|Device related adverse events are presented for the Safety Cohort.
215551|NCT01146613|B3|Baseline|Total|Total of all reporting groups
215552|NCT01146613|B2|Baseline|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
215553|NCT01146613|B1|Baseline|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
215554|NCT01146613|P2|Participant Flow|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
215555|NCT01146613|P1|Participant Flow|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
215556|NCT01146613|O2|Outcome|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
215557|NCT01146613|O1|Outcome|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
215558|NCT01146613|E2|Reported Event|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
215559|NCT01146613|E1|Reported Event|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
215560|NCT01146600|B3|Baseline|Total|Total of all reporting groups
215561|NCT01146600|B2|Baseline|Placebo, Then Clarithromycin|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks"
215562|NCT01146600|B1|Baseline|Clarithromycin, Then Placebo|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks."
215563|NCT01146600|P2|Participant Flow|Placebo, Then Clarithromycin|Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
215564|NCT01146600|P1|Participant Flow|Clarithromycin, Then Placebo|Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
215565|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215566|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215567|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215568|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215569|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215570|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215571|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215572|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215573|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215574|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215575|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215576|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215577|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215578|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215579|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215580|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215581|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215582|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215583|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
215584|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
215585|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215586|NCT01146600|E2|Reported Event|Placebo|Matched placebo with breakfast and with lunch for two weeks
215587|NCT01146600|E1|Reported Event|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
215588|NCT01146418|B3|Baseline|Total|Total of all reporting groups
215589|NCT01146418|B2|Baseline|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215590|NCT01146418|B1|Baseline|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215591|NCT01146418|P4|Participant Flow|recFSH 300 IU Live-Born Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
215592|NCT01146418|P3|Participant Flow|Corifollitropin Alfa 150 μg Live-Born Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
215593|NCT01146418|P2|Participant Flow|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215594|NCT01146418|P1|Participant Flow|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215683|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
215684|NCT01145638|E2|Reported Event|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
215595|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215596|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215597|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215598|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215599|NCT01146418|E6|Reported Event|recFSH 300 IU Follow-up Fetuses/Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
215600|NCT01146418|E5|Reported Event|Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
215601|NCT01146418|E4|Reported Event|recFSH 300 IU Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215602|NCT01146418|E3|Reported Event|Corifollitropin Alfa 150 μg Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215603|NCT01146418|E2|Reported Event|recFSH 300 IU Participants With ET|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215604|NCT01146418|E1|Reported Event|Corifollitropin Alfa 150 μg Participants With ET|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
215605|NCT01146288|B3|Baseline|Total|Total of all reporting groups
215606|NCT01146288|B2|Baseline|Furosemide First, Then Acetazolamide|intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
215607|NCT01146288|B1|Baseline|Acetazolamide First, Then Furosemide|intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).
215608|NCT01146288|P2|Participant Flow|Furosemide First , Than Acetazolamide|Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
215609|NCT01146288|P1|Participant Flow|Acetazolamide First, Then Furosemide|Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).
215610|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
215611|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
215612|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
215613|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
215614|NCT01146288|E3|Reported Event|P-aminohippuric Acid|Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
215615|NCT01146288|E2|Reported Event|Furosemide|Intravenous furosemide 2 mg/5min
215616|NCT01146288|E1|Reported Event|Acetazolamide|Intravenous acetazolamide 5 mg/kg/5 min.
215617|NCT01146275|B1|Baseline|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
215618|NCT01146275|P1|Participant Flow|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
215619|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"
215685|NCT01145638|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
215686|NCT01145625|B3|Baseline|Total|Total of all reporting groups
215620|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment."
215621|NCT01146275|E1|Reported Event|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
215622|NCT01145898|B3|Baseline|Total|Total of all reporting groups
215623|NCT01145898|B2|Baseline|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
215624|NCT01145898|B1|Baseline|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
215625|NCT01145898|P2|Participant Flow|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
215626|NCT01145898|P1|Participant Flow|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
215627|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215628|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215629|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215630|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215631|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215632|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215633|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215634|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215635|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215636|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215637|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215638|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215639|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215640|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215641|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215642|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215643|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215644|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215645|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215646|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215647|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215648|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215649|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215650|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215651|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215652|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215653|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
215654|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
215655|NCT01145898|E1|Reported Event|Glaucoma Patients|Patients with Glaucoma
215656|NCT01145755|B4|Baseline|Total|Total of all reporting groups
215657|NCT01145755|B3|Baseline|Placebo|Placebo
215658|NCT01145755|B2|Baseline|Duloxetine|Duloxetine 30 mg, 60 mg
215659|NCT01145755|B1|Baseline|AZD2066|AZD2066 12 mg, 18 mg
215660|NCT01145755|P3|Participant Flow|Placebo|Placebo
215661|NCT01145755|P2|Participant Flow|Duloxetine|Duloxetine 30 mg, 60 mg
215662|NCT01145755|P1|Participant Flow|AZD2066|AZD2066 12 mg, 18 mg
215663|NCT01145755|O3|Outcome|Placebo|Placebo
215664|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
215665|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
215666|NCT01145755|O3|Outcome|Placebo|Placebo
215667|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
215668|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
215669|NCT01145755|O3|Outcome|Placebo|Placebo
215670|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
215671|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
215672|NCT01145755|E3|Reported Event|Placebo|Placebo
215673|NCT01145755|E2|Reported Event|Duloxetine|Duloxetine 30 mg, 60 mg
215674|NCT01145755|E1|Reported Event|AZD2066|AZD2066 12 mg, 18 mg
215675|NCT01145638|B3|Baseline|Total|Total of all reporting groups
215676|NCT01145638|B2|Baseline|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
215677|NCT01145638|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
215678|NCT01145638|P2|Participant Flow|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
215679|NCT01145638|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
215680|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
215805|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215687|NCT01145625|B2|Baseline|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215688|NCT01145625|B1|Baseline|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215689|NCT01145625|P2|Participant Flow|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215690|NCT01145625|P1|Participant Flow|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215691|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215692|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215693|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215694|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215695|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215696|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215697|NCT01145625|E2|Reported Event|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
215698|NCT01145625|E1|Reported Event|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
215699|NCT01145560|B4|Baseline|Total|Total of all reporting groups
215700|NCT01145560|B3|Baseline|Placebo|Saline
215701|NCT01145560|B2|Baseline|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215702|NCT01145560|B1|Baseline|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215703|NCT01145560|P3|Participant Flow|Placebo|Saline
215704|NCT01145560|P2|Participant Flow|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215705|NCT01145560|P1|Participant Flow|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215706|NCT01145560|O3|Outcome|Placebo|Saline
215707|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215708|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215709|NCT01145560|O3|Outcome|Placebo|Saline
215710|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215711|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215712|NCT01145560|O3|Outcome|Placebo|Saline
215713|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215714|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215715|NCT01145560|O3|Outcome|Placebo|Saline
215716|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215717|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215718|NCT01145560|E3|Reported Event|Placebo|Saline
215719|NCT01145560|E2|Reported Event|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
215720|NCT01145560|E1|Reported Event|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
215721|NCT01145547|B1|Baseline|All Study Participants|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
215722|NCT01145547|P2|Participant Flow|High Glycemic Index, Low Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
215723|NCT01145547|P1|Participant Flow|Low Glycemic Index, High Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
215724|NCT01145547|O2|Outcome|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
215725|NCT01145547|O1|Outcome|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
215726|NCT01145547|E2|Reported Event|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
215727|NCT01145547|E1|Reported Event|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
215728|NCT01145508|B3|Baseline|Total|Total of all reporting groups
215729|NCT01145508|B2|Baseline|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
215806|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215730|NCT01145508|B1|Baseline|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
215731|NCT01145508|P2|Participant Flow|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
215732|NCT01145508|P1|Participant Flow|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
215733|NCT01145508|O2|Outcome|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
215734|NCT01145508|O1|Outcome|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
215735|NCT01145508|E2|Reported Event|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
215736|NCT01145508|E1|Reported Event|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
215737|NCT01145495|B1|Baseline|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
215738|NCT01145495|P1|Participant Flow|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~>~> rituximab: Given IV~>~> lenalidomide: Given orally"
215739|NCT01145495|O1|Outcome|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
215740|NCT01145495|E1|Reported Event|Treatment (Lenalidomide, Rituximab)|lenalidomide: Given orally
215741|NCT01145482|B3|Baseline|Total|Total of all reporting groups
215742|NCT01145482|B2|Baseline|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions
215743|NCT01145482|B1|Baseline|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions
215744|NCT01145482|P2|Participant Flow|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
215745|NCT01145482|P1|Participant Flow|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions
215746|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
215747|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
215748|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
215749|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
215750|NCT01145482|E2|Reported Event|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
215751|NCT01145482|E1|Reported Event|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
215752|NCT01145417|B3|Baseline|Total|Total of all reporting groups
215807|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215753|NCT01145417|B2|Baseline|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215754|NCT01145417|B1|Baseline|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215755|NCT01145417|P2|Participant Flow|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215756|NCT01145417|P1|Participant Flow|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215757|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215758|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215759|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215760|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215761|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215762|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215763|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215764|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215765|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215766|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215767|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215768|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215808|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215809|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215810|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215769|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215770|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215771|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215772|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215773|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215774|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215775|NCT01145417|E2|Reported Event|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215776|NCT01145417|E1|Reported Event|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
215777|NCT01145391|B3|Baseline|Total|Total of all reporting groups
215778|NCT01145391|B2|Baseline|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
215779|NCT01145391|B1|Baseline|Control|Patients receive usual care.
215780|NCT01145391|P2|Participant Flow|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
215781|NCT01145391|P1|Participant Flow|Control|Patients receive usual care.
215782|NCT01145391|O2|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
215783|NCT01145391|O1|Outcome|Control|Patients receive usual care.
215784|NCT01145391|O2|Outcome|Usual Care|Usual care
215785|NCT01145391|O1|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
215786|NCT01145391|E2|Reported Event|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
215787|NCT01145391|E1|Reported Event|Control|Patients receive usual care.
215788|NCT01144299|B3|Baseline|Total|Total of all reporting groups
215789|NCT01144299|B2|Baseline|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215790|NCT01144299|B1|Baseline|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215791|NCT01144299|P2|Participant Flow|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215792|NCT01144299|P1|Participant Flow|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215793|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215794|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215795|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215796|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215797|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215798|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215799|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215800|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215801|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215802|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215803|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
215804|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
215920|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
215815|NCT01144286|B3|Baseline|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
215816|NCT01144286|B2|Baseline|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
215817|NCT01144286|B1|Baseline|Placebo|placebo pessary, single dose
215818|NCT01144286|P4|Participant Flow|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
215819|NCT01144286|P3|Participant Flow|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
215820|NCT01144286|P2|Participant Flow|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
215821|NCT01144286|P1|Participant Flow|Placebo|placebo pessary, single dose
215822|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
215823|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
215824|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
215825|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
215826|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
215827|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
215828|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
215829|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
215830|NCT01144286|E4|Reported Event|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
215831|NCT01144286|E3|Reported Event|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
215832|NCT01144286|E2|Reported Event|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
215833|NCT01144286|E1|Reported Event|Placebo|placebo pessary, single dose
215834|NCT01145352|B1|Baseline|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215835|NCT01145352|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215836|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215837|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215838|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215839|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215840|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215841|NCT01145352|E1|Reported Event|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
215842|NCT01145053|B1|Baseline|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215843|NCT01145053|P1|Participant Flow|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215844|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215845|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215846|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215847|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215848|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215849|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215850|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215851|NCT01145053|E1|Reported Event|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
215852|NCT01145001|B5|Baseline|Total|Total of all reporting groups
215853|NCT01145001|B4|Baseline|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
215854|NCT01145001|B3|Baseline|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
215855|NCT01145001|B2|Baseline|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215856|NCT01145001|B1|Baseline|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215857|NCT01145001|P4|Participant Flow|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
215858|NCT01145001|P3|Participant Flow|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
215921|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
215922|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
215923|NCT01144624|E3|Reported Event|Placebo|Saline
215859|NCT01145001|P2|Participant Flow|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215860|NCT01145001|P1|Participant Flow|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215861|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
215862|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
215863|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215864|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215865|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
215866|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
215867|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215868|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215869|NCT01145001|E4|Reported Event|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
215870|NCT01145001|E3|Reported Event|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
215871|NCT01145001|E2|Reported Event|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215872|NCT01145001|E1|Reported Event|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
215873|NCT01144949|B3|Baseline|Total|Total of all reporting groups
215874|NCT01144949|B2|Baseline|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215875|NCT01144949|B1|Baseline|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215876|NCT01144949|P2|Participant Flow|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215877|NCT01144949|P1|Participant Flow|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215878|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215879|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215880|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215881|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215882|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215883|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215884|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215885|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215886|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215887|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215888|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215889|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215890|NCT01144949|E2|Reported Event|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
215891|NCT01144949|E1|Reported Event|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
215892|NCT01144715|B3|Baseline|Total|Total of all reporting groups
215893|NCT01144715|B2|Baseline|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215924|NCT01144624|E2|Reported Event|Dose Cohort 2|AZD9773 500/100 units/kg IV
215894|NCT01144715|B1|Baseline|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215895|NCT01144715|P2|Participant Flow|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215896|NCT01144715|P1|Participant Flow|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215897|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215898|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215899|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215900|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215901|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215902|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215903|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215904|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215905|NCT01144715|E2|Reported Event|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
215906|NCT01144715|E1|Reported Event|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
215907|NCT01144624|B4|Baseline|Total|Total of all reporting groups
215908|NCT01144624|B3|Baseline|Placebo|Saline
215909|NCT01144624|B2|Baseline|Dose Cohort 2|AZD9773 500/100 units/kg IV
215910|NCT01144624|B1|Baseline|Dose Cohort 1|AZD9773 250/50 units/kg IV
215911|NCT01144624|P3|Participant Flow|Placebo|Saline
215912|NCT01144624|P2|Participant Flow|Dose Cohort 2|AZD9773 500/100 units/kg IV
215913|NCT01144624|P1|Participant Flow|Dose Cohort 1|AZD9773 250/50 units/kg IV
215914|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
215915|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
215916|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
215917|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
215926|NCT01144598|B1|Baseline|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215927|NCT01144598|P1|Participant Flow|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215928|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215929|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215930|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215931|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215932|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215933|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215934|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215935|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215936|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215937|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215938|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215939|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215940|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215941|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215942|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215943|NCT01144598|E1|Reported Event|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
215944|NCT01144442|B1|Baseline|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
215945|NCT01144442|P1|Participant Flow|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
215946|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
215947|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
215948|NCT01144442|E1|Reported Event|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
215949|NCT01144416|B3|Baseline|Total|Total of all reporting groups
215950|NCT01144416|B2|Baseline|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215951|NCT01144416|B1|Baseline|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
215952|NCT01144416|P2|Participant Flow|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215953|NCT01144416|P1|Participant Flow|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
215954|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215955|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
216146|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
215956|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215957|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
215958|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
215959|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
215960|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215961|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
215962|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
215963|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
215964|NCT01144416|E4|Reported Event|Daily 300 IU recFSH -Follow-up|Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
215965|NCT01144416|E3|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962-Follow-up|Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
215966|NCT01144416|E2|Reported Event|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
215967|NCT01144416|E1|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
215968|NCT01144403|B1|Baseline|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215969|NCT01144403|P1|Participant Flow|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215970|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215971|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215972|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215973|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~cyclophosphamide: as prescribed, 6 cycles~fludarabine: as prescribed, 6 cycles~mitoxantrone: as prescribed, 6 cycles~rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles"
215974|NCT01144403|E1|Reported Event|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
215975|NCT01144364|B3|Baseline|Total|Total of all reporting groups
216536|NCT01142466|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
215976|NCT01144364|B2|Baseline|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215977|NCT01144364|B1|Baseline|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215978|NCT01144364|P3|Participant Flow|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215979|NCT01144364|P2|Participant Flow|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215980|NCT01144364|P1|Participant Flow|Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)|"Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1*, fludarabine (F): 25 mg/m^2 IV on Days 2-4*, mitoxantrone (N): 10 mg/m^2 IV on Day 2*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4*. Cycles were repeated every 28 days for a total of 4 cycles.~*In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1."
215981|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215982|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215983|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215984|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215985|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215986|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215987|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215988|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215989|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215990|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215991|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215992|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
216038|NCT01144052|B1|Baseline|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
216039|NCT01144052|P2|Participant Flow|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
215993|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215994|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215995|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215996|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215997|NCT01144364|O1|Outcome|Rituximab Induction|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
215998|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
215999|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
216000|NCT01144364|E3|Reported Event|Rituximab Induction, Observation Maintenance (Follow-up Phase)|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
216040|NCT01144052|P1|Participant Flow|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
216041|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216537|NCT01142388|B3|Baseline|Total|Total of all reporting groups
216001|NCT01144364|E2|Reported Event|Rituximab Induction, Rituximab Maintenance (Follow-up Phase)|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
216002|NCT01144364|E1|Reported Event|Rituximab Induction (Induction Phase Only)|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses)."
216003|NCT01144182|B3|Baseline|Total|Total of all reporting groups
216004|NCT01144182|B2|Baseline|Comprehensive Quality Improvement Program (QIP)|Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
216005|NCT01144182|B1|Baseline|Current Best Practice (CBP)|Current best practice (CBP) receives the current treatment for patients discharged with heart failure
216006|NCT01144182|P2|Participant Flow|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216007|NCT01144182|P1|Participant Flow|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216008|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216009|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216010|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216011|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216012|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216013|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216014|NCT01144182|O2|Outcome|Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216015|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216016|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216017|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216675|NCT01140906|B5|Baseline|Total|Total of all reporting groups
216018|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216019|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216020|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216021|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216022|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216023|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216024|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216025|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216026|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216027|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216028|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216029|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216030|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216031|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216032|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216033|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216034|NCT01144182|E2|Reported Event|Quality Improvement Program (QIP)|"Quality improvement program (QIP)~The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
216035|NCT01144182|E1|Reported Event|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
216036|NCT01144052|B3|Baseline|Total|Total of all reporting groups
216037|NCT01144052|B2|Baseline|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216676|NCT01140906|B4|Baseline|Duloxetine 60 mg|encapsulated capsules, daily, orally
216042|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216043|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216044|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216045|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216046|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216047|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
216048|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
216049|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
216050|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
216051|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216052|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216053|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216054|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216055|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216056|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
216057|NCT01144052|E2|Reported Event|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
216058|NCT01144052|E1|Reported Event|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
216059|NCT01144026|B3|Baseline|Total|Total of all reporting groups
216060|NCT01144026|B2|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
216061|NCT01144026|B1|Baseline|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
216062|NCT01144026|P2|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
216063|NCT01144026|P1|Participant Flow|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
216064|NCT01144026|O2|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
216065|NCT01144026|O1|Outcome|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
216066|NCT01144026|E2|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
216067|NCT01144026|E1|Reported Event|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
216068|NCT01143896|B3|Baseline|Total|Total of all reporting groups
216069|NCT01143896|B2|Baseline|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216111|NCT01143792|O2|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
216112|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
225989|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
216070|NCT01143896|B1|Baseline|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216071|NCT01143896|P2|Participant Flow|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216072|NCT01143896|P1|Participant Flow|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
216073|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216074|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216075|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216076|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216077|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216078|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216079|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216080|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216081|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216113|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
216145|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
216082|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
216083|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216084|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216085|NCT01143896|E2|Reported Event|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
216086|NCT01143896|E1|Reported Event|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
216087|NCT01143883|B3|Baseline|Total|Total of all reporting groups
216088|NCT01143883|B2|Baseline|Standard of Care Dressing|55
216089|NCT01143883|B1|Baseline|Silverlon Dressing|55
216090|NCT01143883|P2|Participant Flow|Standard of Care Dressing|The standard plain gauze is used to dress the wound postoperatively
216091|NCT01143883|P1|Participant Flow|Silverlon Dressing|The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
216092|NCT01143883|O2|Outcome|Standard of Care Dressing|55
216093|NCT01143883|O1|Outcome|Silverlon Dressing|55
216094|NCT01143883|E2|Reported Event|Standard of Care Dressing|55
216095|NCT01143883|E1|Reported Event|Silverlon Dressing|55
216096|NCT01143818|B1|Baseline|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216097|NCT01143818|P1|Participant Flow|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216098|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216099|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216100|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216101|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216102|NCT01143818|E1|Reported Event|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
216103|NCT01143792|B4|Baseline|Total|Total of all reporting groups
216104|NCT01143792|B3|Baseline|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
216105|NCT01143792|B2|Baseline|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
216106|NCT01143792|B1|Baseline|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
216107|NCT01143792|P3|Participant Flow|Case Management + HIV Prevention|Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
216108|NCT01143792|P2|Participant Flow|MET + HIV Prevention|Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
216109|NCT01143792|P1|Participant Flow|CRA + HIV Prevention|Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
216110|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
225990|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
216114|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
216115|NCT01143792|O1|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
216116|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216117|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216118|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216119|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216120|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216121|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216122|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216123|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216124|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216125|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216126|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216127|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216128|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216129|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216130|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216131|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216132|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216133|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
216134|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
216135|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
216136|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
216137|NCT01143792|E3|Reported Event|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
216138|NCT01143792|E2|Reported Event|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
216139|NCT01143792|E1|Reported Event|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
216140|NCT01143766|B3|Baseline|Total|Total of all reporting groups
216141|NCT01143766|B2|Baseline|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
216142|NCT01143766|B1|Baseline|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
216143|NCT01143766|P2|Participant Flow|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
216144|NCT01143766|P1|Participant Flow|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
225991|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
216147|NCT01143766|E2|Reported Event|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
216148|NCT01143766|E1|Reported Event|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
216149|NCT01143727|B3|Baseline|Total|Total of all reporting groups
216150|NCT01143727|B2|Baseline|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
216151|NCT01143727|B1|Baseline|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
216152|NCT01143727|P2|Participant Flow|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
216153|NCT01143727|P1|Participant Flow|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
216154|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
216155|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
216156|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
216157|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
216158|NCT01143727|E2|Reported Event|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
216159|NCT01143727|E1|Reported Event|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
216160|NCT01143714|B3|Baseline|Total|Total of all reporting groups
216161|NCT01143714|B2|Baseline|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216162|NCT01143714|B1|Baseline|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216163|NCT01143714|P2|Participant Flow|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216164|NCT01143714|P1|Participant Flow|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216165|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216166|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216167|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216168|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216169|NCT01143714|E2|Reported Event|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216170|NCT01143714|E1|Reported Event|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
216171|NCT01143701|B3|Baseline|Total|Total of all reporting groups
216172|NCT01143701|B2|Baseline|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
216173|NCT01143701|B1|Baseline|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
216174|NCT01143701|P2|Participant Flow|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
216175|NCT01143701|P1|Participant Flow|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics ADHD guidelines."
216176|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
216177|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
216178|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
216179|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
216180|NCT01143701|E2|Reported Event|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
216181|NCT01143701|E1|Reported Event|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
216182|NCT01143610|B3|Baseline|Total|Total of all reporting groups
216183|NCT01143610|B2|Baseline|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
216184|NCT01143610|B1|Baseline|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
216185|NCT01143610|P2|Participant Flow|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
216186|NCT01143610|P1|Participant Flow|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
216187|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
216188|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
216189|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
216190|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
216191|NCT01143610|E2|Reported Event|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
216192|NCT01143610|E1|Reported Event|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
216193|NCT01143337|B3|Baseline|Total|Total of all reporting groups
216194|NCT01143337|B2|Baseline|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216195|NCT01143337|B1|Baseline|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216196|NCT01143337|P3|Participant Flow|MP-435 400mg BID|MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
216197|NCT01143337|P2|Participant Flow|MP-435 100mg BID|MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
216198|NCT01143337|P1|Participant Flow|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216199|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216200|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216201|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216202|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216203|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216204|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216205|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216206|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216259|NCT01143207|B1|Baseline|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216207|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216208|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216209|NCT01143337|E2|Reported Event|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
216210|NCT01143337|E1|Reported Event|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
216211|NCT01143324|B1|Baseline|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216212|NCT01143324|P1|Participant Flow|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216213|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216214|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216215|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216216|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216217|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216218|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216219|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216220|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216221|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216222|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216223|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216224|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216225|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216226|NCT01143324|E1|Reported Event|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
216227|NCT01143272|B3|Baseline|Total|Total of all reporting groups
216228|NCT01143272|B2|Baseline|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216229|NCT01143272|B1|Baseline|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216230|NCT01143272|P2|Participant Flow|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216231|NCT01143272|P1|Participant Flow|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216232|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216233|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216354|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216234|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216235|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216236|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216237|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216238|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216239|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216240|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216241|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216242|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216243|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216244|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216245|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216246|NCT01143272|E2|Reported Event|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
216247|NCT01143272|E1|Reported Event|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
216248|NCT01143259|B3|Baseline|Total|Total of all reporting groups
216249|NCT01143259|B2|Baseline|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
216250|NCT01143259|B1|Baseline|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216251|NCT01143259|P2|Participant Flow|Alvimopan|Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
216252|NCT01143259|P1|Participant Flow|300 mg Polyethylene|Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216253|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
216254|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216255|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
216256|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216257|NCT01143259|E2|Reported Event|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216258|NCT01143259|E1|Reported Event|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
216677|NCT01140906|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216260|NCT01143207|P1|Participant Flow|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216261|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216262|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216263|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216264|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216265|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216266|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216267|NCT01143207|E1|Reported Event|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
216268|NCT01143142|B3|Baseline|Total|Total of all reporting groups
216269|NCT01143142|B2|Baseline|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216270|NCT01143142|B1|Baseline|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216271|NCT01143142|P2|Participant Flow|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216272|NCT01143142|P1|Participant Flow|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216273|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216274|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216275|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216276|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216277|NCT01143142|E2|Reported Event|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216278|NCT01143142|E1|Reported Event|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
216279|NCT01143090|B1|Baseline|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
216280|NCT01143090|P1|Participant Flow|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
216281|NCT01143090|O1|Outcome|Lurasidone Overall|
216282|NCT01143090|E1|Reported Event|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
216283|NCT01143077|B4|Baseline|Total|Total of all reporting groups
216284|NCT01143077|B3|Baseline|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
216285|NCT01143077|B2|Baseline|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
216286|NCT01143077|B1|Baseline|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
216287|NCT01143077|P3|Participant Flow|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
216288|NCT01143077|P2|Participant Flow|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
216289|NCT01143077|P1|Participant Flow|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
216290|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
216291|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
216292|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
216293|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
216294|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
216295|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
216296|NCT01143077|E3|Reported Event|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
216297|NCT01143077|E2|Reported Event|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
216298|NCT01143077|E1|Reported Event|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
216299|NCT01143051|B7|Baseline|Total|Total of all reporting groups
216300|NCT01143051|B6|Baseline|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
216301|NCT01143051|B5|Baseline|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
216302|NCT01143051|B4|Baseline|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
216303|NCT01143051|B3|Baseline|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
216304|NCT01143051|B2|Baseline|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
216305|NCT01143051|B1|Baseline|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
216306|NCT01143051|P6|Participant Flow|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
216355|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216678|NCT01140906|B2|Baseline|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216307|NCT01143051|P5|Participant Flow|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
216308|NCT01143051|P4|Participant Flow|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
216309|NCT01143051|P3|Participant Flow|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
216310|NCT01143051|P2|Participant Flow|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
216311|NCT01143051|P1|Participant Flow|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
216312|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216313|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216314|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216315|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216316|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216317|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216318|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216319|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216320|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216321|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216322|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216323|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216324|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216325|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216326|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216327|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
216328|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
216329|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
216330|NCT01143051|E3|Reported Event|Treatment C|"Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.~epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations"
216331|NCT01143051|E2|Reported Event|Treatment T2|"HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations"
216332|NCT01143051|E1|Reported Event|Treatment T1|"T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations"
216333|NCT01143038|B1|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216356|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216357|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216358|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216334|NCT01143038|P1|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216335|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216336|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216337|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216338|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216339|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216340|NCT01143038|E1|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
216341|NCT01142908|B3|Baseline|Total|Total of all reporting groups
216342|NCT01142908|B2|Baseline|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216343|NCT01142908|B1|Baseline|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216344|NCT01142908|P2|Participant Flow|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216345|NCT01142908|P1|Participant Flow|Pharmacist CVD|The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216346|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216347|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216348|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216349|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216350|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216351|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216352|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216353|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216359|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216360|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216361|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216362|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216363|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216364|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216365|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216366|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216367|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216368|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216369|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216370|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216371|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216372|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216373|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216374|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216375|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216376|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216377|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216378|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216379|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216380|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216381|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216382|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216383|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216384|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216385|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216386|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216387|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216388|NCT01142908|E2|Reported Event|Education Control|The education control group - these participants will receive educational material about CVD reduction.
216389|NCT01142908|E1|Reported Event|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
216390|NCT01142726|B4|Baseline|Total|Total of all reporting groups
216391|NCT01142726|B3|Baseline|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216392|NCT01142726|B2|Baseline|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216393|NCT01142726|B1|Baseline|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216420|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216421|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216422|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216394|NCT01142726|P3|Participant Flow|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216395|NCT01142726|P2|Participant Flow|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216396|NCT01142726|P1|Participant Flow|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept subcutaneous (SC) 125 mg/week and MTX.
216397|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216398|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216399|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216400|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216401|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216423|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216424|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216679|NCT01140906|B1|Baseline|Placebo|capsules, daily, orally
216402|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216403|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216404|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216405|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216406|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216407|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216408|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216409|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216425|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216426|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216410|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216411|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216412|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216413|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216414|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216415|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216416|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216417|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
216418|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216419|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216680|NCT01140906|P4|Participant Flow|Duloxetine 60 mg|encapsulated capsules, daily, orally
216427|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
216428|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
216429|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
216430|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
216431|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
216432|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
216433|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216434|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216435|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216436|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216437|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216438|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216439|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216440|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216441|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216442|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216443|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216444|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216445|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216446|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216447|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216448|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216449|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216450|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216451|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216452|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
216453|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
216454|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
216455|NCT01142726|E3|Reported Event|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
216456|NCT01142726|E2|Reported Event|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
216457|NCT01142726|E1|Reported Event|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC 125 mg/week and MTX. Safety data was collected from Day 1 to 56 days post last dose.
216458|NCT01142661|B1|Baseline|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
216459|NCT01142661|P1|Participant Flow|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
216460|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
216461|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
216462|NCT01142661|E1|Reported Event|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
216463|NCT01142596|B3|Baseline|Total|Total of all reporting groups
216464|NCT01142596|B2|Baseline|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216465|NCT01142596|B1|Baseline|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216466|NCT01142596|P2|Participant Flow|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216467|NCT01142596|P1|Participant Flow|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124 (NCT01098110), and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216468|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216469|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216470|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216528|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216529|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216681|NCT01140906|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216471|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216472|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216473|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216474|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216475|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216476|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216477|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216478|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216479|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216480|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216481|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216482|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216483|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216484|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216485|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216486|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216530|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216531|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216532|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216487|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216488|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216489|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216490|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216491|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216492|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216493|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216494|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216495|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216496|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216497|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216498|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216499|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216500|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216501|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216502|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216533|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216534|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216535|NCT01142466|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
216503|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216504|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216505|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216506|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216507|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216508|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216509|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216510|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216511|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216512|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216513|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216514|NCT01142596|E2|Reported Event|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216515|NCT01142596|E1|Reported Event|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
216516|NCT01142466|B3|Baseline|Total|Total of all reporting groups
216517|NCT01142466|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
216518|NCT01142466|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216519|NCT01142466|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
216520|NCT01142466|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216521|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216522|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216523|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216524|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216525|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216526|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
216527|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
216682|NCT01140906|P2|Participant Flow|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216538|NCT01142388|B2|Baseline|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216539|NCT01142388|B1|Baseline|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216540|NCT01142388|P2|Participant Flow|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216541|NCT01142388|P1|Participant Flow|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216542|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216543|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216544|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216545|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216546|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216547|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216548|NCT01142388|E2|Reported Event|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
216549|NCT01142388|E1|Reported Event|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
216550|NCT01142323|B1|Baseline|Fenofibrate|fenofibrate 160 mg po daily
216551|NCT01142323|P1|Participant Flow|Fenofibrate|fenofibrate 160 mg po daily
216552|NCT01142323|O2|Outcome|At 6 Months|fenofibrate 160 mg/day
216553|NCT01142323|O1|Outcome|Baseline|Prior to drug intervention
216554|NCT01142323|E1|Reported Event|Fenofibrate|fenofibrate 160 mg po daily
216555|NCT01142297|B1|Baseline|Dental Implant|"standard SLA surface and chemically modified surface~dental implant : standard SLA surface and modified dental implant : chemically modified surface"
216556|NCT01142297|P1|Participant Flow|Dental Implant|standard SLA surface and chemically-modified surface implant
216557|NCT01142297|O2|Outcome|Modified SLA Minimum ISQ HbA1c<9.5|"chemically modified surface~modified dental implant : chemically modified surface"
216558|NCT01142297|O1|Outcome|SLA Minimum ISQ HbA1c<9.5|"standard SLA surface~dental implant : standard SLA surface"
216559|NCT01142297|E2|Reported Event|Modified Dental Implant|"chemically modified surface~modified dental implant : chemically modified surface"
216560|NCT01142297|E1|Reported Event|Dental Implant|"standard SLA surface~dental implant : standard SLA surface"
216561|NCT01142193|B3|Baseline|Total|Total of all reporting groups
216562|NCT01142193|B2|Baseline|Placebo|Placebo
216563|NCT01142193|B1|Baseline|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216564|NCT01142193|P2|Participant Flow|Placebo|Placebo
216565|NCT01142193|P1|Participant Flow|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216566|NCT01142193|O2|Outcome|Placebo|Placebo
216567|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216568|NCT01142193|O2|Outcome|Placebo|Placebo
216569|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216570|NCT01142193|O2|Outcome|Placebo|Placebo
216571|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216572|NCT01142193|O2|Outcome|Placebo|Placebo
216573|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216574|NCT01142193|O2|Outcome|Placebo|Placebo
216575|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216576|NCT01142193|O2|Outcome|Placebo|Placebo
216577|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216578|NCT01142193|O2|Outcome|Placebo|Placebo
216579|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216580|NCT01142193|O2|Outcome|Placebo|Placebo
216581|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216582|NCT01142193|O2|Outcome|Placebo|Placebo
216583|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216584|NCT01142193|O2|Outcome|Placebo|Placebo
216585|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216586|NCT01142193|E2|Reported Event|Placebo|Placebo
216587|NCT01142193|E1|Reported Event|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
216588|NCT01142128|B5|Baseline|Total|Total of all reporting groups
216589|NCT01142128|B4|Baseline|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
216683|NCT01140906|P1|Participant Flow|Placebo|capsules, daily, orally
216590|NCT01142128|B3|Baseline|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216591|NCT01142128|B2|Baseline|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
216592|NCT01142128|B1|Baseline|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
216593|NCT01142128|P1|Participant Flow|All Participants|"Participants received one of four interventions in a randomized crossover design:~Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium~Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone"
216594|NCT01142128|O1|Outcome|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216595|NCT01142128|O1|Outcome|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216596|NCT01142128|O1|Outcome|Placebo to Nexium, Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216597|NCT01142128|O1|Outcome|Nexium Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216598|NCT01142128|E4|Reported Event|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
216599|NCT01142128|E3|Reported Event|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
216600|NCT01142128|E2|Reported Event|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
216601|NCT01142128|E1|Reported Event|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
216602|NCT01142115|B1|Baseline|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
216603|NCT01142115|P2|Participant Flow|Monza First, Then SpeediCath|Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
216604|NCT01142115|P1|Participant Flow|SpeediCath First, Then Monza|Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.
216605|NCT01142115|O2|Outcome|SpeediCath|Control Product
216606|NCT01142115|O1|Outcome|Monza|Test product
216607|NCT01142115|O2|Outcome|SpeediCath|Control Product
216608|NCT01142115|O1|Outcome|Monza|Test product
216609|NCT01142115|O2|Outcome|SpeediCath|Control Product
216610|NCT01142115|O1|Outcome|Monza|Test product
216611|NCT01142115|O2|Outcome|SpeediCath|Control Product
216612|NCT01142115|O1|Outcome|Monza|Test product
216613|NCT01142115|O2|Outcome|SpeediCath|Control Product
216614|NCT01142115|O1|Outcome|Monza|Test product
216615|NCT01142115|O2|Outcome|SpeediCath|Control Product
216616|NCT01142115|O1|Outcome|Monza|Test product
216617|NCT01142115|E1|Reported Event|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
216618|NCT01141660|B3|Baseline|Total|Total of all reporting groups
216619|NCT01141660|B2|Baseline|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216620|NCT01141660|B1|Baseline|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216621|NCT01141660|P2|Participant Flow|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216622|NCT01141660|P1|Participant Flow|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216623|NCT01141660|O2|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216624|NCT01141660|O1|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216625|NCT01141660|E2|Reported Event|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216626|NCT01141660|E1|Reported Event|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
216627|NCT01141595|B1|Baseline|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
216628|NCT01141595|P1|Participant Flow|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
216629|NCT01141595|O1|Outcome|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
216630|NCT01141595|E1|Reported Event|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
216631|NCT01141491|B3|Baseline|Total|Total of all reporting groups
216632|NCT01141491|B2|Baseline|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216684|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216685|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216633|NCT01141491|B1|Baseline|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216634|NCT01141491|P2|Participant Flow|Arm B - OPT-821 Immunologic Adjuvant|Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216635|NCT01141491|P1|Participant Flow|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216636|NCT01141491|O2|Outcome|Arm B - OPT-821 Immunologic Adjuvant|"Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84~OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84"
216637|NCT01141491|O1|Outcome|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216638|NCT01141491|E2|Reported Event|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216639|NCT01141491|E1|Reported Event|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
216640|NCT01141374|B4|Baseline|Total|Total of all reporting groups
216641|NCT01141374|B3|Baseline|Control Group|untreated group
216642|NCT01141374|B2|Baseline|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
216643|NCT01141374|B1|Baseline|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
216644|NCT01141374|P3|Participant Flow|Control Group|untreated group
216645|NCT01141374|P2|Participant Flow|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
216646|NCT01141374|P1|Participant Flow|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
216647|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
216648|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
216649|NCT01141374|O1|Outcome|Control Group|Without intervention
216650|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
216651|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
216652|NCT01141374|O1|Outcome|Control Group|Without intervention
216653|NCT01141374|E3|Reported Event|Control Group|untreated group
216654|NCT01141374|E2|Reported Event|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
216655|NCT01141374|E1|Reported Event|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
216656|NCT01141283|B1|Baseline|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
216657|NCT01141283|P1|Participant Flow|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
216658|NCT01141283|O1|Outcome|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
216659|NCT01141283|E1|Reported Event|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
216660|NCT01141205|B3|Baseline|Total|Total of all reporting groups
216661|NCT01141205|B2|Baseline|Saline|Saline injection
216662|NCT01141205|B1|Baseline|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
216663|NCT01141205|P2|Participant Flow|Saline|Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8
216664|NCT01141205|P1|Participant Flow|AFO-18|18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
216665|NCT01141205|O2|Outcome|Placebo|participants receiving saline
216666|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
216667|NCT01141205|O2|Outcome|Saline|Placebo participants receiving sterile saline i.m.
216668|NCT01141205|O1|Outcome|Vaccinee|participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
216669|NCT01141205|O2|Outcome|Placebo Saline|Saline injection
216670|NCT01141205|O1|Outcome|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
216671|NCT01141205|O2|Outcome|Placebo|participants receiving saline
216672|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
216673|NCT01141205|E2|Reported Event|Saline|Saline injection
216674|NCT01141205|E1|Reported Event|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
216686|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216687|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216688|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216689|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216690|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216691|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216692|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216693|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216694|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216695|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216696|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216697|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216698|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216699|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216700|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216701|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216702|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216703|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216704|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216705|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216706|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216707|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216708|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216709|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216710|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216711|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216712|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
216713|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
216714|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
216715|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
216716|NCT01140906|E4|Reported Event|Duloxetine 60 mg|
216717|NCT01140906|E3|Reported Event|Vortioxetine 20 mg|
216718|NCT01140906|E2|Reported Event|Vortioxetine 15 mg|
216719|NCT01140906|E1|Reported Event|Placebo|
216720|NCT01140880|B3|Baseline|Total|Total of all reporting groups
216721|NCT01140880|B2|Baseline|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216722|NCT01140880|B1|Baseline|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216723|NCT01140880|P2|Participant Flow|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216724|NCT01140880|P1|Participant Flow|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216725|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216726|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216727|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216760|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216761|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216762|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216763|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216728|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216729|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216730|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216731|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216732|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216733|NCT01140880|E2|Reported Event|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216734|NCT01140880|E1|Reported Event|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
216735|NCT01140867|B1|Baseline|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216736|NCT01140867|P1|Participant Flow|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216737|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216738|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216739|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216740|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216741|NCT01140867|E1|Reported Event|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
216742|NCT01140815|B3|Baseline|Total|Total of all reporting groups
216743|NCT01140815|B2|Baseline|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216744|NCT01140815|B1|Baseline|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216745|NCT01140815|P2|Participant Flow|Deuce|The Journey Deuce Bicompartmental Knee System
216746|NCT01140815|P1|Participant Flow|Total|The Smith and Nephew Total Knee System
216747|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216748|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216749|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216750|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216751|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216752|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216753|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216754|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216755|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216756|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216757|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216758|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216759|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216765|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216766|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216767|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216768|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216769|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216770|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216771|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
216772|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
216773|NCT01140815|E2|Reported Event|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
216774|NCT01140815|E1|Reported Event|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
216775|NCT01140646|B1|Baseline|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
216776|NCT01140646|P1|Participant Flow|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
216777|NCT01140646|O1|Outcome|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
216778|NCT01140646|E1|Reported Event|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
216779|NCT01140503|B1|Baseline|Apremilast|All subjects received apremilast 20mg PO BID
216780|NCT01140503|P1|Participant Flow|Apremilast|All subjects received apremilast 20mg PO BID
216781|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
216782|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
216783|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
216784|NCT01140503|E1|Reported Event|Apremilast|All subjects received apremilast 20mg PO BID
216785|NCT01140477|B3|Baseline|Total|Total of all reporting groups
216786|NCT01140477|B2|Baseline|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
216787|NCT01140477|B1|Baseline|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
216788|NCT01140477|P2|Participant Flow|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
216789|NCT01140477|P1|Participant Flow|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
216790|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
216791|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
216792|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
216793|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
216794|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
216795|NCT01140477|E2|Reported Event|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
216796|NCT01140477|E1|Reported Event|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
216797|NCT01140347|B3|Baseline|Total|Total of all reporting groups
216798|NCT01140347|B2|Baseline|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216799|NCT01140347|B1|Baseline|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216800|NCT01140347|P2|Participant Flow|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216801|NCT01140347|P1|Participant Flow|Ramucirumab (IMC-1121B) + BSC|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.~Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator."
216802|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216803|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216804|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216805|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216806|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216807|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216808|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216809|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216810|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216811|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216812|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216813|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216814|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216815|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216816|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216817|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216818|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216819|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216820|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216821|NCT01140347|E2|Reported Event|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216822|NCT01140347|E1|Reported Event|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
216823|NCT01140295|B3|Baseline|Total|Total of all reporting groups
216824|NCT01140295|B2|Baseline|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216825|NCT01140295|B1|Baseline|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216826|NCT01140295|P2|Participant Flow|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
216827|NCT01140295|P1|Participant Flow|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216828|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
216829|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216830|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216831|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216832|NCT01140295|E2|Reported Event|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216833|NCT01140295|E1|Reported Event|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
216834|NCT01140061|B11|Baseline|Total|Total of all reporting groups
216835|NCT01140061|B10|Baseline|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
216836|NCT01140061|B9|Baseline|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216837|NCT01140061|B8|Baseline|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
216838|NCT01140061|B7|Baseline|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
216839|NCT01140061|B6|Baseline|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
216840|NCT01140061|B5|Baseline|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216841|NCT01140061|B4|Baseline|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
216842|NCT01140061|B3|Baseline|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216843|NCT01140061|B2|Baseline|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
216844|NCT01140061|B1|Baseline|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216845|NCT01140061|P10|Participant Flow|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
216846|NCT01140061|P9|Participant Flow|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216847|NCT01140061|P8|Participant Flow|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
216848|NCT01140061|P7|Participant Flow|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
216849|NCT01140061|P6|Participant Flow|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
216850|NCT01140061|P5|Participant Flow|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216851|NCT01140061|P4|Participant Flow|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
216852|NCT01140061|P3|Participant Flow|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216853|NCT01140061|P2|Participant Flow|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
217075|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
216854|NCT01140061|P1|Participant Flow|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216855|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
216856|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216857|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
216858|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216859|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216860|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216861|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
216862|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216863|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
216864|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216865|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216866|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216867|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216868|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
216869|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216870|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216871|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216872|NCT01140061|O2|Outcome|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
216873|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216874|NCT01140061|E6|Reported Event|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
216875|NCT01140061|E5|Reported Event|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
216876|NCT01140061|E4|Reported Event|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
216877|NCT01140061|E3|Reported Event|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
216878|NCT01140061|E2|Reported Event|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
216879|NCT01140061|E1|Reported Event|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
216880|NCT01140048|B1|Baseline|All Enrolled Participants|
216881|NCT01140048|P1|Participant Flow|All Enrolled Participants|
216882|NCT01140048|O1|Outcome|All Enrolled Participants|
216883|NCT01140048|O1|Outcome|All Enrolled Participants|
216884|NCT01140048|O1|Outcome|All Enrolled Participants|
216885|NCT01140048|E1|Reported Event|All Enrolled Participants|
216886|NCT01139879|B1|Baseline|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
216887|NCT01139879|P1|Participant Flow|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
216888|NCT01139879|O1|Outcome|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
216889|NCT01139879|O1|Outcome|P400|The P400 mattress will be placed for a period of 12 weeks for all enrolled patients
216890|NCT01139879|O1|Outcome|P400 Support Surface|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
216891|NCT01139879|E1|Reported Event|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
216892|NCT01139814|B1|Baseline|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
216893|NCT01139814|P1|Participant Flow|Intent-to-Treat|"Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.~Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices."
216894|NCT01139814|O1|Outcome|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
216895|NCT01139814|O1|Outcome|Intent-to-Treat|A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
216896|NCT01139814|E1|Reported Event|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
216897|NCT01139762|B3|Baseline|Total|Total of all reporting groups
216898|NCT01139762|B2|Baseline|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216899|NCT01139762|B1|Baseline|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216900|NCT01139762|P3|Participant Flow|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
216901|NCT01139762|P2|Participant Flow|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
216902|NCT01139762|P1|Participant Flow|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
216903|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216904|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216905|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216906|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216907|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216908|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216909|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216910|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216911|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216912|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216913|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216914|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216915|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216916|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216917|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216918|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216919|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216920|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216921|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216922|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216923|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216924|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216925|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216926|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216927|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216928|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216929|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
216930|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
217920|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
216931|NCT01139762|E3|Reported Event|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
216932|NCT01139762|E2|Reported Event|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
216933|NCT01139762|E1|Reported Event|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
216934|NCT01139658|B3|Baseline|Total|Total of all reporting groups
216935|NCT01139658|B2|Baseline|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216936|NCT01139658|B1|Baseline|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216937|NCT01139658|P2|Participant Flow|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216938|NCT01139658|P1|Participant Flow|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216939|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216940|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216941|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216942|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216943|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216944|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216945|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216946|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216947|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216948|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216949|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216950|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216951|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216952|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216953|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216954|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216955|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216956|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216957|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216958|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216959|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216960|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216961|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
217070|NCT01139164|P1|Participant Flow|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
216962|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216963|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216964|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216965|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216966|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216967|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216968|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216969|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216970|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216971|NCT01139658|E2|Reported Event|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216972|NCT01139658|E1|Reported Event|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
216973|NCT01139580|B3|Baseline|Total|Total of all reporting groups
216974|NCT01139580|B2|Baseline|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216975|NCT01139580|B1|Baseline|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216976|NCT01139580|P2|Participant Flow|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216977|NCT01139580|P1|Participant Flow|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
216978|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216979|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216980|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216981|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216982|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216983|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216984|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216985|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216986|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216987|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216988|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216989|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216990|NCT01139580|E2|Reported Event|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216991|NCT01139580|E1|Reported Event|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
216992|NCT01139515|B1|Baseline|Entire Study Population|All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
216993|NCT01139515|P4|Participant Flow|Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg|Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
216994|NCT01139515|P3|Participant Flow|Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg|Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
216995|NCT01139515|P2|Participant Flow|Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
217071|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
216996|NCT01139515|P1|Participant Flow|Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
216997|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
216998|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
216999|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217000|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217001|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
217002|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
217003|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217004|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217005|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
217006|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
217007|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217008|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217009|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
217010|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
217011|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217012|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217013|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
217014|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
217015|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217016|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217017|NCT01139515|E4|Reported Event|Eletriptan 40 mg 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
217018|NCT01139515|E3|Reported Event|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
217019|NCT01139515|E2|Reported Event|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
217020|NCT01139515|E1|Reported Event|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
217021|NCT01139450|B4|Baseline|Total|Total of all reporting groups
217022|NCT01139450|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
217023|NCT01139450|B2|Baseline|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
217024|NCT01139450|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
217025|NCT01139450|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
217026|NCT01139450|P2|Participant Flow|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
217027|NCT01139450|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
217028|NCT01139450|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
217029|NCT01139450|O2|Outcome|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
217030|NCT01139450|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
217031|NCT01139450|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
217032|NCT01139450|E2|Reported Event|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
217033|NCT01139450|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
217034|NCT01139411|B3|Baseline|Total|Total of all reporting groups
217035|NCT01139411|B2|Baseline|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217036|NCT01139411|B1|Baseline|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217072|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
217073|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
217037|NCT01139411|P2|Participant Flow|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217038|NCT01139411|P1|Participant Flow|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217039|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217040|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217041|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217042|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217043|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217044|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217045|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217046|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217047|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217048|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217049|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217050|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217051|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217052|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217053|NCT01139411|E2|Reported Event|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
217054|NCT01139411|E1|Reported Event|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
217055|NCT01139190|B3|Baseline|Total|Total of all reporting groups
217056|NCT01139190|B2|Baseline|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
217057|NCT01139190|B1|Baseline|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
217058|NCT01139190|P2|Participant Flow|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
217059|NCT01139190|P1|Participant Flow|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
217060|NCT01139190|O2|Outcome|Naproxen|Naproxen: Oral administration
217061|NCT01139190|O1|Outcome|PL3100|PL3100: Oral administration
217062|NCT01139190|E2|Reported Event|Naproxen|Naproxen: Oral administration
217063|NCT01139190|E1|Reported Event|PL3100|PL3100: Oral administration
217064|NCT01139164|B4|Baseline|Total|Total of all reporting groups
217065|NCT01139164|B3|Baseline|Group 3: Regimen C|B-Cell Lymphomas
217066|NCT01139164|B2|Baseline|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
217067|NCT01139164|B1|Baseline|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
217068|NCT01139164|P3|Participant Flow|Group 3: Regimen C|B-Cell Lymphomas
217069|NCT01139164|P2|Participant Flow|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
217074|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
217076|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
217077|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
217078|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
217079|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
217080|NCT01139164|E3|Reported Event|Group 3: Regimen C|B-Cell Lymphomas
217081|NCT01139164|E2|Reported Event|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
217082|NCT01139164|E1|Reported Event|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
217083|NCT01139125|B1|Baseline|Cystagon|One black male and two white males started the study
217084|NCT01139125|P1|Participant Flow|Cystagon (Cysteamine Bitartrate)|Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
217085|NCT01139125|O1|Outcome|Cystagon|Subjects are required to take 14 capsules per day for 16 weeks
217086|NCT01139125|E1|Reported Event|Cystagon|Subjects taking 14 capsules per day for 16 weeks
217087|NCT01139047|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
217088|NCT01139047|P1|Participant Flow|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
217089|NCT01139047|O1|Outcome|MetroGel® 1% and Finacea Gel® 15%|This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks
217090|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
217091|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217092|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
217093|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217094|NCT01139047|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks
217095|NCT01139047|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217096|NCT01139021|B7|Baseline|Total|Total of all reporting groups
217097|NCT01139021|B6|Baseline|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
217098|NCT01139021|B5|Baseline|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217099|NCT01139021|B4|Baseline|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217100|NCT01139021|B3|Baseline|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217101|NCT01139021|B2|Baseline|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
217102|NCT01139021|B1|Baseline|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
217103|NCT01139021|P6|Participant Flow|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
217104|NCT01139021|P5|Participant Flow|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217105|NCT01139021|P4|Participant Flow|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217106|NCT01139021|P3|Participant Flow|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217107|NCT01139021|P2|Participant Flow|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
217108|NCT01139021|P1|Participant Flow|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
217109|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217110|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217111|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
217112|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
217113|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
217175|NCT01138969|E1|Reported Event|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
225992|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
217114|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
217115|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217116|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217117|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217118|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217119|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
217120|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217121|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217122|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
217123|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217124|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217125|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
217126|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217127|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217128|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
217129|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
217130|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
217131|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
217132|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
217133|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
217134|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
217135|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
217136|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
217137|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
217138|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
217139|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
217140|NCT01139021|E3|Reported Event|B24_26|Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
217141|NCT01139021|E2|Reported Event|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.
217142|NCT01139021|E1|Reported Event|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
217176|NCT01138826|B1|Baseline|Entire Study Population|All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
217143|NCT01139008|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
217144|NCT01139008|P1|Participant Flow|MetroGel® 1% and Finacea 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
217145|NCT01139008|O1|Outcome|MetroGel® 1% and Finacea® Gel 15%|This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
217146|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
217147|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217148|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
217149|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217150|NCT01139008|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
217151|NCT01139008|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
217152|NCT01138995|B3|Baseline|Total|Total of all reporting groups
217153|NCT01138995|B2|Baseline|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
217154|NCT01138995|B1|Baseline|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
217155|NCT01138995|P2|Participant Flow|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
217156|NCT01138995|P1|Participant Flow|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
217157|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
217158|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
217159|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
217160|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
217161|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
217162|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
217163|NCT01138995|E2|Reported Event|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
217164|NCT01138995|E1|Reported Event|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO) for 30 weeks."
217165|NCT01138969|B3|Baseline|Total|Total of all reporting groups
217166|NCT01138969|B2|Baseline|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
217167|NCT01138969|B1|Baseline|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
217168|NCT01138969|P2|Participant Flow|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
217169|NCT01138969|P1|Participant Flow|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
217170|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
217171|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
217172|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
217173|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
217174|NCT01138969|E2|Reported Event|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
217177|NCT01138826|P6|Participant Flow|Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
217178|NCT01138826|P5|Participant Flow|Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
217179|NCT01138826|P4|Participant Flow|Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
217180|NCT01138826|P3|Participant Flow|Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
217181|NCT01138826|P2|Participant Flow|Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
217182|NCT01138826|P1|Participant Flow|Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
217183|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217184|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217185|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217186|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217187|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217188|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217189|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217190|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217191|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
225993|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
217192|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217193|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217194|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217195|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217196|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217197|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217198|NCT01138826|E3|Reported Event|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217199|NCT01138826|E2|Reported Event|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217200|NCT01138826|E1|Reported Event|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
217201|NCT01138735|B3|Baseline|Total|Total of all reporting groups
217202|NCT01138735|B2|Baseline|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217203|NCT01138735|B1|Baseline|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217204|NCT01138735|P2|Participant Flow|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217205|NCT01138735|P1|Participant Flow|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217206|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217207|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217208|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217209|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217210|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217211|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217212|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217213|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217214|NCT01138735|E2|Reported Event|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
217215|NCT01138735|E1|Reported Event|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
217216|NCT01138657|B3|Baseline|Total|Total of all reporting groups
217280|NCT01138514|E2|Reported Event|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
225994|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
217217|NCT01138657|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217218|NCT01138657|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217219|NCT01138657|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217220|NCT01138657|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217221|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217222|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217223|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217224|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217225|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217226|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217227|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217228|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217229|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217230|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217231|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217232|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217233|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217281|NCT01138514|E1|Reported Event|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217638|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
217234|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217235|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217236|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217237|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217238|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217239|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217240|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217241|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217242|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217243|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217244|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217245|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217246|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217247|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217248|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217249|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217250|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217251|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217252|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217253|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217254|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217255|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217256|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217257|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217258|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217259|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217260|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217261|NCT01138657|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217262|NCT01138657|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
217263|NCT01138514|B4|Baseline|Total|Total of all reporting groups
217264|NCT01138514|B3|Baseline|Vehicle|Placebo: Placebo
217265|NCT01138514|B2|Baseline|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
217266|NCT01138514|B1|Baseline|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217267|NCT01138514|P3|Participant Flow|Vehicle|Placebo: Placebo
217268|NCT01138514|P2|Participant Flow|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
217269|NCT01138514|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217270|NCT01138514|O3|Outcome|Vehicle|Placebo
217271|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
217272|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217273|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
217274|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
217275|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217276|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
217277|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
217278|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
217279|NCT01138514|E3|Reported Event|Vehicle|Placebo: Placebo
217639|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
217282|NCT01138501|B1|Baseline|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
217283|NCT01138501|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
217284|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
217285|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
217286|NCT01138501|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
217287|NCT01138150|B3|Baseline|Total|Total of all reporting groups
217288|NCT01138150|B2|Baseline|Sugar Pill|Participants randomized to placebo (sugar pill) during acute migraine attack.
217289|NCT01138150|B1|Baseline|Treximet|Participants randomized to active drug Treximet during acute migraine attack.
217290|NCT01138150|P2|Participant Flow|Placebo|Participants randomized to placebo upon presentation with acute migraine attack.
217291|NCT01138150|P1|Participant Flow|Active Drug - Sumatriptan/Naproxen|Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
217292|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217293|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217294|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217295|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217296|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217297|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217298|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217299|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217300|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217301|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217302|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217303|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217304|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217305|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217306|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217307|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217308|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
218028|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
217309|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217310|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217311|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217312|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217313|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217314|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217315|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217316|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217317|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217318|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217319|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217320|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217321|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217322|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217323|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217324|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217325|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217326|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217327|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217328|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217329|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217330|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217331|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217332|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
217333|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
217334|NCT01138150|O6|Outcome|Treatment Non-Responders|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
217335|NCT01138150|O5|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
217336|NCT01138150|O4|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
217337|NCT01138150|O3|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
217338|NCT01138150|O2|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
217339|NCT01138150|O1|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
217340|NCT01138150|E2|Reported Event|Sugar Pill|Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
217341|NCT01138150|E1|Reported Event|Treximet|sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
217342|NCT01138124|B5|Baseline|Total|Total of all reporting groups
217343|NCT01138124|B4|Baseline|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
217344|NCT01138124|B3|Baseline|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
217345|NCT01138124|B2|Baseline|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
217346|NCT01138124|B1|Baseline|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
217347|NCT01138124|P4|Participant Flow|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
217348|NCT01138124|P3|Participant Flow|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
217349|NCT01138124|P2|Participant Flow|Pancreatic Cancer Controls|"Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.~The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin."
217350|NCT01138124|P1|Participant Flow|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
217351|NCT01138124|O2|Outcome|Controls|Controls
217352|NCT01138124|O1|Outcome|Cases|Cases
217353|NCT01138124|O2|Outcome|Controls|Controls
217354|NCT01138124|O1|Outcome|Cases|Cases
217355|NCT01138124|O2|Outcome|Controls|Controls
217356|NCT01138124|O1|Outcome|Cases|Cases
217357|NCT01138124|O2|Outcome|Controls|Controls
217358|NCT01138124|O1|Outcome|Cases|Cases
217359|NCT01138124|O2|Outcome|Controls|Controls
217360|NCT01138124|O1|Outcome|Cases|Cases
217361|NCT01138124|O2|Outcome|Controls|Controls
217362|NCT01138124|O1|Outcome|Cases|Cases
217363|NCT01138124|O2|Outcome|Controls|Controls
217364|NCT01138124|O1|Outcome|Cases|Cases
217365|NCT01138124|O2|Outcome|Controls|Controls
217366|NCT01138124|O1|Outcome|Cases|Cases
217367|NCT01138124|E4|Reported Event|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
217368|NCT01138124|E3|Reported Event|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
217448|NCT01138007|P1|Participant Flow|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217369|NCT01138124|E2|Reported Event|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
217370|NCT01138124|E1|Reported Event|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
217371|NCT01138111|B1|Baseline|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
217372|NCT01138111|P1|Participant Flow|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
217373|NCT01138111|O6|Outcome|24 Month 90 Min|24 month PET scan at 90 min post-injection
217374|NCT01138111|O5|Outcome|24 Month 45 Min|24 month PET scan at 45 min post-injection
217375|NCT01138111|O4|Outcome|12 Month 90 Min|12 month PET scan at 90 min post-injection
217376|NCT01138111|O3|Outcome|12 Month 45 Min|12 month PET scan at 45 min post-injection
217377|NCT01138111|O2|Outcome|Baseline 90 Min|Baseline PET scan at 90 min post-injection
217378|NCT01138111|O1|Outcome|Baseline 45 Min|Baseline PET scan at 45 min post-injection
217379|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|24 month PET scan results for subjects who progressed to AD within the two year follow up period
217380|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
217381|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|12 month PET scan results for subjects who progressed to AD within the two year follow up period
217382|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
217383|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Baseline PET scan results for subjects who progressed to AD within the two year follow up period
217384|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
217385|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
217386|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
217387|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
217388|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
217389|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
217390|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
217391|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
217392|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
217393|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
217394|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
217395|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
217396|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
217397|NCT01138111|E3|Reported Event|MCI Subjects (2nd Repeat Drug Administration)|Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
217398|NCT01138111|E2|Reported Event|MCI Subjects (1st Repeat Drug Administration)|Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit
217399|NCT01138111|E1|Reported Event|MCI Subjects (Initial Drug Administration)|Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit
217400|NCT01138098|B3|Baseline|Total|Total of all reporting groups
217401|NCT01138098|B2|Baseline|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217402|NCT01138098|B1|Baseline|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217403|NCT01138098|P2|Participant Flow|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217404|NCT01138098|P1|Participant Flow|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217405|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217406|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217407|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217408|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217409|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217410|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217411|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217412|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217413|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217414|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217415|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217416|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217417|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217418|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217419|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217420|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217421|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217422|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217423|NCT01138098|E2|Reported Event|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217424|NCT01138098|E1|Reported Event|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
217425|NCT01138046|B1|Baseline|Lapatinib 1500mg + Paclitaxel 80mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217469|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217426|NCT01138046|P1|Participant Flow|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217427|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217428|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217429|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217430|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217431|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217432|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217433|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217434|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217435|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217436|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217437|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217438|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217439|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217440|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217441|NCT01138046|E1|Reported Event|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
217442|NCT01138007|B4|Baseline|Total|Total of all reporting groups
217443|NCT01138007|B3|Baseline|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217444|NCT01138007|B2|Baseline|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217445|NCT01138007|B1|Baseline|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217446|NCT01138007|P3|Participant Flow|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217447|NCT01138007|P2|Participant Flow|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217449|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217450|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217451|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217452|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217453|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217454|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217455|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217456|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217457|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217458|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217459|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217460|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217461|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217462|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217463|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217464|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217465|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217466|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217467|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217468|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217470|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217471|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217472|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217473|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217474|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217475|NCT01138007|O1|Outcome|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217476|NCT01138007|E3|Reported Event|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
217477|NCT01138007|E2|Reported Event|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
217478|NCT01138007|E1|Reported Event|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
217479|NCT01137812|B3|Baseline|Total|Total of all reporting groups
217480|NCT01137812|B2|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217481|NCT01137812|B1|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217482|NCT01137812|P2|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217483|NCT01137812|P1|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217484|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217485|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217486|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217487|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217488|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217489|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217490|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217491|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217492|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217493|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217494|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217495|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217496|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217497|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217498|NCT01137812|E2|Reported Event|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217499|NCT01137812|E1|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
217500|NCT01137786|B3|Baseline|Total|Total of all reporting groups
217501|NCT01137786|B2|Baseline|Iopamidol 370 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
217502|NCT01137786|B1|Baseline|Iodixanol 320 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
217503|NCT01137786|P2|Participant Flow|Iopamidol 370|Non ionic contrast media comparator : one time administration for PCI
217504|NCT01137786|P1|Participant Flow|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
217505|NCT01137786|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iopamidol 370.
217506|NCT01137786|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370.
217507|NCT01137786|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320.
217508|NCT01137786|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320.
217509|NCT01137786|E2|Reported Event|Iopamidol 370|Non ionic contrast media comparator : One time administration for PCI
217510|NCT01137786|E1|Reported Event|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
217511|NCT01137682|B4|Baseline|Total|Total of all reporting groups
217512|NCT01137682|B3|Baseline|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
217513|NCT01137682|B2|Baseline|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217514|NCT01137682|B1|Baseline|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217515|NCT01137682|P3|Participant Flow|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
217516|NCT01137682|P2|Participant Flow|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217517|NCT01137682|P1|Participant Flow|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217518|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
217519|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217520|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217521|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
217522|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217523|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217524|NCT01137682|E3|Reported Event|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
217525|NCT01137682|E2|Reported Event|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217526|NCT01137682|E1|Reported Event|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
217527|NCT01137604|B5|Baseline|Total|Total of all reporting groups
217528|NCT01137604|B4|Baseline|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217529|NCT01137604|B3|Baseline|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217530|NCT01137604|B2|Baseline|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217531|NCT01137604|B1|Baseline|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217532|NCT01137604|P4|Participant Flow|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217533|NCT01137604|P3|Participant Flow|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
225995|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
217534|NCT01137604|P2|Participant Flow|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217535|NCT01137604|P1|Participant Flow|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217536|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217537|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217538|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217539|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217540|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217541|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217542|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217543|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217544|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217545|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217546|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217547|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217548|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217549|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217550|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217551|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217552|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217553|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217554|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217555|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217556|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217557|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217558|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217559|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217560|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217561|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217562|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
218516|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
217563|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217564|NCT01137604|E4|Reported Event|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217565|NCT01137604|E3|Reported Event|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217566|NCT01137604|E2|Reported Event|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
217567|NCT01137604|E1|Reported Event|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
217568|NCT01137578|B1|Baseline|All Imaged Participants|Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217569|NCT01137578|P3|Participant Flow|Sub-Study Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
217570|NCT01137578|P2|Participant Flow|Cohort B|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
217571|NCT01137578|P1|Participant Flow|Cohort A|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
217572|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217573|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217574|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217575|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217576|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217587|NCT01137578|O2|Outcome|All Imaged Participants: Unilateral Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but a study-related unilateral US instead of a bilateral US was completed. Bilateral US was the protocol-defined procedure but if the participant was not able to complete a bilateral US, then the unilateral US was accepted for evaluation. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
225996|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
217577|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217578|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217579|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217580|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217581|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217582|NCT01137578|O3|Outcome|Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
217583|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217584|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, should have been switched to Cohort B.
217585|NCT01137578|O4|Outcome|All Imaged Participants: No MRI With Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI with contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217586|NCT01137578|O3|Outcome|All Imaged Participants: No MRI Without Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI without contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217588|NCT01137578|O1|Outcome|All Imaged Participants: No Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but no study-related US (either bilateral or unilateral) was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217589|NCT01137578|O6|Outcome|Cohort C Participants 12Years to 18 Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217590|NCT01137578|O5|Outcome|Cohort C Participants <12Years of Age|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC.
217591|NCT01137578|O4|Outcome|Cohort B Participants 12Years to 18 Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217592|NCT01137578|O3|Outcome|Cohort B Participants <12Years of Age|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without contrast enhancement) were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217593|NCT01137578|O2|Outcome|Cohort A Participants 12Years to 18 Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217594|NCT01137578|O1|Outcome|Cohort A Participants <12Years of Age|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Diagnostic imaging procedures included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was allowed.
217595|NCT01137578|O3|Outcome|Cohort C|Participants with a CVC in place and having an MRI for clinical reasons were enrolled.
217596|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217597|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, were switched to Cohort B.
217598|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217636|NCT01137435|P1|Participant Flow|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
225997|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
217599|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217600|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217601|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
217602|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217603|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217604|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
217605|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217606|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217607|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
217608|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217609|NCT01137578|E1|Reported Event|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
217610|NCT01137474|B5|Baseline|Total|Total of all reporting groups
217611|NCT01137474|B4|Baseline|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217637|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
217612|NCT01137474|B3|Baseline|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
217613|NCT01137474|B2|Baseline|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
217614|NCT01137474|B1|Baseline|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217615|NCT01137474|P4|Participant Flow|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217616|NCT01137474|P3|Participant Flow|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
217617|NCT01137474|P2|Participant Flow|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
217618|NCT01137474|P1|Participant Flow|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217619|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217620|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217621|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217622|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217623|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217624|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217625|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217626|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217627|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217628|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217629|NCT01137474|O2|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217630|NCT01137474|O1|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217631|NCT01137474|E4|Reported Event|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
217632|NCT01137474|E3|Reported Event|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
217633|NCT01137474|E2|Reported Event|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
217634|NCT01137474|E1|Reported Event|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
217635|NCT01137435|B1|Baseline|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
218517|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
217640|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
217641|NCT01137435|E1|Reported Event|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
217642|NCT01137396|B3|Baseline|Total|Total of all reporting groups
217643|NCT01137396|B2|Baseline|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217644|NCT01137396|B1|Baseline|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217645|NCT01137396|P2|Participant Flow|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217646|NCT01137396|P1|Participant Flow|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217647|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217648|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217649|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217650|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217651|NCT01137396|E2|Reported Event|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217652|NCT01137396|E1|Reported Event|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
217653|NCT01137370|B3|Baseline|Total|Total of all reporting groups
217654|NCT01137370|B2|Baseline|People Without TB|
217655|NCT01137370|B1|Baseline|Patients With TB|
217656|NCT01137370|P2|Participant Flow|People Without TB|
217657|NCT01137370|P1|Participant Flow|Patients With TB|
217658|NCT01137370|O2|Outcome|People Without TB|
217659|NCT01137370|O1|Outcome|Patients With TB|
217660|NCT01137370|E2|Reported Event|People Without TB|
217661|NCT01137370|E1|Reported Event|Patients With TB|
217662|NCT01137292|B1|Baseline|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217663|NCT01137292|P1|Participant Flow|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217664|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217665|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217666|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217707|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217919|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217667|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217668|NCT01137292|E1|Reported Event|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
217669|NCT01137071|B1|Baseline|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217670|NCT01137071|P1|Participant Flow|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217671|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217672|NCT01137071|O1|Outcome|Pharmacokinetic|All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
217673|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217674|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217675|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217676|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217677|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217678|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217679|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217680|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217681|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217682|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217683|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217684|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217685|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217686|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217687|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217688|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217689|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217690|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217691|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217692|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217693|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217694|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217695|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217696|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217697|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217698|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217699|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217700|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217701|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217702|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217703|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217704|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217705|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217706|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217708|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
217709|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217710|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217711|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
217712|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217713|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217714|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217715|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217716|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217717|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
217718|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217719|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217720|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217721|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217722|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217723|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217724|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217725|NCT01137071|O1|Outcome|hu3S193|hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
217726|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217727|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217728|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217729|NCT01137071|E1|Reported Event|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
217730|NCT01137032|B1|Baseline|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217731|NCT01137032|P1|Participant Flow|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217732|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217733|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217734|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217735|NCT01137032|E1|Reported Event|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
217736|NCT01136967|B3|Baseline|Total|Total of all reporting groups
217737|NCT01136967|B2|Baseline|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217738|NCT01136967|B1|Baseline|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217739|NCT01136967|P2|Participant Flow|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217740|NCT01136967|P1|Participant Flow|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217741|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217742|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217788|NCT01136876|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
217743|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217744|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217745|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217746|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217747|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217748|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217749|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217750|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217751|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217752|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217753|NCT01136967|E2|Reported Event|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217754|NCT01136967|E1|Reported Event|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
217755|NCT01136954|B3|Baseline|Total|Total of all reporting groups
217756|NCT01136954|B2|Baseline|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217757|NCT01136954|B1|Baseline|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217758|NCT01136954|P2|Participant Flow|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217759|NCT01136954|P1|Participant Flow|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217760|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217761|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
225998|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
217762|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217763|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217764|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217765|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217766|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217767|NCT01136954|O1|Outcome|Zonisamide (Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217768|NCT01136954|E2|Reported Event|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
217769|NCT01136954|E1|Reported Event|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
217770|NCT01136915|B3|Baseline|Total|Total of all reporting groups
217771|NCT01136915|B2|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
217772|NCT01136915|B1|Baseline|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
217773|NCT01136915|P2|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
217774|NCT01136915|P1|Participant Flow|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
217775|NCT01136915|O4|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
217776|NCT01136915|O3|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
217777|NCT01136915|O2|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
217778|NCT01136915|O1|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
217779|NCT01136915|E2|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
217780|NCT01136915|E1|Reported Event|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
217781|NCT01136876|B3|Baseline|Total|Total of all reporting groups
217782|NCT01136876|B2|Baseline|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
217783|NCT01136876|B1|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
217784|NCT01136876|P2|Participant Flow|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
217785|NCT01136876|P1|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
217786|NCT01136876|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
217787|NCT01136876|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
217789|NCT01136876|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
217790|NCT01136876|E2|Reported Event|Iopamidol 370|Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention
217791|NCT01136876|E1|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
217792|NCT01136772|B3|Baseline|Total|Total of all reporting groups
217793|NCT01136772|B2|Baseline|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
217794|NCT01136772|B1|Baseline|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
217795|NCT01136772|P2|Participant Flow|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
217796|NCT01136772|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
217797|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
217798|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
217799|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
217800|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
217801|NCT01136772|E2|Reported Event|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
217802|NCT01136772|E1|Reported Event|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
217803|NCT01136746|B3|Baseline|Total|Total of all reporting groups
217804|NCT01136746|B2|Baseline|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217805|NCT01136746|B1|Baseline|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217806|NCT01136746|P2|Participant Flow|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217807|NCT01136746|P1|Participant Flow|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217808|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217809|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217810|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217811|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217812|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217813|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217814|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217815|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217816|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217817|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217818|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217819|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217868|NCT01136655|O4|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
217820|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217821|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217822|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217823|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217824|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217825|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217826|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217827|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217828|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217829|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217830|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217831|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217832|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217833|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217834|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217835|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217836|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217837|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217838|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217839|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217840|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217841|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217842|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217918|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217843|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217844|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217845|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217846|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217847|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217848|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217849|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217850|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217851|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217852|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217853|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217854|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217855|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217856|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217857|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217858|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217859|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217860|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217861|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217862|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217863|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217864|NCT01136746|E2|Reported Event|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
217865|NCT01136746|E1|Reported Event|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
217866|NCT01136655|B1|Baseline|Randomized Patients|All randomized patients
217867|NCT01136655|P1|Participant Flow|Randomized Patients|All randomized patients
225999|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
217869|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
217870|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
217871|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
217872|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
217873|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
217874|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
217875|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
217876|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
217877|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
217878|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
217879|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
217880|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
217881|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
217882|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
217883|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
217884|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
217885|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
217886|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
217887|NCT01136655|E5|Reported Event|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
217888|NCT01136655|E4|Reported Event|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
217889|NCT01136655|E3|Reported Event|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
217890|NCT01136655|E2|Reported Event|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
217891|NCT01136655|E1|Reported Event|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
217892|NCT01136486|B1|Baseline|Level of Severity of TBI|Four categories based on pain severity (no pain, mild, moderate and severe pain).
217893|NCT01136486|P1|Participant Flow|Treatment Arm|Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
217894|NCT01136486|O1|Outcome|Severity of Pain by Severity of Injury|
217895|NCT01136486|E1|Reported Event|Severity of Pain by Severity of Injury|
217896|NCT01136408|B4|Baseline|Total|Total of all reporting groups
217897|NCT01136408|B3|Baseline|Warfarin|Dose-adjusted warfarin based on target INR values
217898|NCT01136408|B2|Baseline|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217899|NCT01136408|B1|Baseline|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217900|NCT01136408|P3|Participant Flow|Warfarin|Dose-adjusted warfarin based on target INR values
217901|NCT01136408|P2|Participant Flow|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217902|NCT01136408|P1|Participant Flow|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217903|NCT01136408|O3|Outcome|Warfarin|"Dose-adjusted warfarin based on target INR values~Warfarin: Dose-adjusted warfarin based on target INR values"
217904|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|"Dabigatran etexilate 150 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration"
217905|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|"Dabigatran etexilate 110 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration"
217906|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217907|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217908|NCT01136408|O3|Outcome|Warfarin|
217909|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217910|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217911|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217912|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217913|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217914|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217915|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217916|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217917|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217921|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217922|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217923|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217924|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217925|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217926|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217927|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217928|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217929|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217930|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217931|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217932|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217933|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217934|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217935|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217936|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217937|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217938|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217939|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217940|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217941|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217942|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217943|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217944|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217945|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217946|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217947|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217948|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217949|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217950|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
217951|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217952|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217953|NCT01136408|E3|Reported Event|Warfarin|Dose-adjusted warfarin based on target INR values
217954|NCT01136408|E2|Reported Event|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
217955|NCT01136408|E1|Reported Event|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
217956|NCT01136382|B3|Baseline|Total|Total of all reporting groups
217957|NCT01136382|B2|Baseline|Budesonide|Budesonide pMDI 160 mcg bid
217958|NCT01136382|B1|Baseline|Placebo|Placebo pMDI bid
217959|NCT01136382|P2|Participant Flow|Budesonide|Budesonide pMDI 160 mcg bid
217960|NCT01136382|P1|Participant Flow|Placebo|Placebo pMDI bid
217961|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217962|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217963|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217964|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217965|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217966|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217967|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217968|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217969|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217970|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217971|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217972|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217973|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217974|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217975|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217976|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217977|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217978|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217979|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217980|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217981|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
217982|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
217983|NCT01136382|E2|Reported Event|Placebo pMDI b.i.d.|
217984|NCT01136382|E1|Reported Event|Budesonide pMDI 160mcg b.i.d.|
217985|NCT01136291|B3|Baseline|Total|Total of all reporting groups
218518|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
217986|NCT01136291|B2|Baseline|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217987|NCT01136291|B1|Baseline|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217988|NCT01136291|P2|Participant Flow|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217989|NCT01136291|P1|Participant Flow|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217990|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217991|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217992|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217993|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217994|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217995|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217996|NCT01136291|E2|Reported Event|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
217997|NCT01136291|E1|Reported Event|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
217998|NCT01136226|B1|Baseline|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
217999|NCT01136226|P1|Participant Flow|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
218000|NCT01136226|O1|Outcome|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
218001|NCT01136226|E1|Reported Event|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
218002|NCT01136174|B5|Baseline|Total|Total of all reporting groups
218003|NCT01136174|B4|Baseline|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218004|NCT01136174|B3|Baseline|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218005|NCT01136174|B2|Baseline|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218006|NCT01136174|B1|Baseline|Placebo|Placebo oral administration twice a day
218007|NCT01136174|P4|Participant Flow|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218008|NCT01136174|P3|Participant Flow|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218009|NCT01136174|P2|Participant Flow|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218010|NCT01136174|P1|Participant Flow|Placebo|Placebo oral administration twice a day
218011|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218012|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218013|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218014|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218015|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218016|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218017|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218018|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218019|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218020|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218021|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218022|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218023|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218024|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
218025|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218026|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
218027|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
218029|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218030|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
218031|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
218032|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
218033|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218034|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
218035|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
218036|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
218037|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218038|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218039|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218040|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218041|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218042|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218043|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218044|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218045|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218046|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218047|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218048|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218049|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218050|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218051|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218052|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218053|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218054|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218055|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218056|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218057|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218058|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218059|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218060|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218061|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218062|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218063|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218064|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218065|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218066|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218067|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218068|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218069|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218070|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218071|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218072|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218073|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218074|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218075|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218076|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218077|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218078|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218079|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218080|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218081|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
218082|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
218083|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
218084|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
218085|NCT01136174|E4|Reported Event|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
218086|NCT01136174|E3|Reported Event|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
218087|NCT01136174|E2|Reported Event|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
218088|NCT01136174|E1|Reported Event|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
218089|NCT01135992|B1|Baseline|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218090|NCT01135992|P1|Participant Flow|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218091|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218092|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218093|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218094|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218095|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218096|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218097|NCT01135992|E1|Reported Event|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
218098|NCT01135914|B4|Baseline|Total|Total of all reporting groups
218099|NCT01135914|B3|Baseline|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218100|NCT01135914|B2|Baseline|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218101|NCT01135914|B1|Baseline|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218102|NCT01135914|P3|Participant Flow|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218103|NCT01135914|P2|Participant Flow|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218104|NCT01135914|P1|Participant Flow|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218105|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218106|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218107|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218108|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218109|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218110|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218111|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218112|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218113|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218114|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218115|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218116|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218117|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218118|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218119|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218120|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218121|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218122|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218123|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218124|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218125|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218126|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218127|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218128|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218129|NCT01135914|E3|Reported Event|Laser Monotherapy|Participants received Laser photocoagulation therapy only
218130|NCT01135914|E2|Reported Event|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
218131|NCT01135914|E1|Reported Event|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
218132|NCT01135524|B1|Baseline|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
218133|NCT01135524|P1|Participant Flow|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
218134|NCT01135524|O1|Outcome|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
218135|NCT01135524|E1|Reported Event|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
218136|NCT01135511|B10|Baseline|Total|Total of all reporting groups
218137|NCT01135511|B9|Baseline|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218138|NCT01135511|B8|Baseline|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218139|NCT01135511|B7|Baseline|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218140|NCT01135511|B6|Baseline|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218141|NCT01135511|B5|Baseline|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218142|NCT01135511|B4|Baseline|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218143|NCT01135511|B3|Baseline|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218144|NCT01135511|B2|Baseline|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218145|NCT01135511|B1|Baseline|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218146|NCT01135511|P9|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218147|NCT01135511|P8|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218148|NCT01135511|P7|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218149|NCT01135511|P6|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218150|NCT01135511|P5|Participant Flow|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218151|NCT01135511|P4|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218152|NCT01135511|P3|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218153|NCT01135511|P2|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218154|NCT01135511|P1|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218519|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
226000|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
218155|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218156|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218157|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218158|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218159|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218160|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218161|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218162|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218163|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218164|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218165|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218166|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218167|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218168|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218169|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218170|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218171|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218172|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218173|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218520|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218174|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218175|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218176|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218177|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218178|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218179|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218180|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218181|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218182|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218183|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218184|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218185|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218186|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218187|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218188|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218189|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218190|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218191|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218192|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
226001|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
218193|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218194|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218195|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218196|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218197|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218198|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218199|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218200|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218201|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218202|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218203|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218204|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218205|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218206|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218207|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218208|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218209|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218210|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218211|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
226002|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
218212|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218213|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218214|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218215|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218216|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218217|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218218|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218219|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218220|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218221|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218222|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218223|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218224|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218225|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218226|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218227|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218228|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218229|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218230|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
226003|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
218231|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218232|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218233|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218234|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218235|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218236|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218237|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218238|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218239|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218240|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218241|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218242|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218243|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218244|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218245|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218246|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218247|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218248|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218249|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218521|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218250|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218251|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218252|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218253|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218254|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218255|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218256|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218257|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218258|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218259|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218260|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218261|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218262|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218263|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218264|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218265|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218266|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218267|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218268|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218522|NCT01135368|O3|Outcome|Pathological|Participants with pathological color vision at Baseline.
218269|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218270|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218271|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218272|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218273|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218274|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218275|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218276|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218277|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218278|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218279|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218280|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218281|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218282|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218283|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218284|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218285|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218286|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218287|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
226004|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
218288|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218289|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218290|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218291|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218292|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218293|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218294|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218295|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218296|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218297|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218298|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218299|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218300|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218301|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218302|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218303|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218304|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218305|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218306|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218523|NCT01135368|O2|Outcome|Normal|Participants with normal color vision at Baseline.
218307|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218308|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218309|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218310|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218311|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218312|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218313|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218314|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218315|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218316|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218317|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218318|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218319|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218320|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218321|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218322|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218323|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218324|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218325|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218524|NCT01135368|O1|Outcome|No Data|Participants with no color vision data at Baseline.
218326|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218327|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218328|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218329|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218330|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218331|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218332|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218333|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218334|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218335|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218336|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218337|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218338|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218339|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218340|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218341|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218342|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218343|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218344|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
226005|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
218345|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218346|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218347|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218348|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218349|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218350|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218351|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218352|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218353|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218354|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218355|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218356|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218357|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218358|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218359|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218360|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218361|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218362|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218363|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
226006|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
218364|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218365|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218366|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218367|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218368|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218369|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218370|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218371|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218372|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218373|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218374|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218375|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218376|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218377|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218378|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218379|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218380|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218381|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218382|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
226007|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
218383|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218384|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218385|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218386|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218387|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218388|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218389|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218390|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218391|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218392|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218393|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218394|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218395|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218396|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218397|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218398|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218399|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218400|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218401|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218580|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218402|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218403|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218404|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218405|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218406|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218407|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218408|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218409|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218410|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218411|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218412|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218413|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218414|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218415|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218416|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218417|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218418|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218419|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218420|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218581|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218421|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218422|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218423|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218424|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218425|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218426|NCT01135511|E9|Reported Event|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218427|NCT01135511|E8|Reported Event|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218428|NCT01135511|E7|Reported Event|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218429|NCT01135511|E6|Reported Event|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218430|NCT01135511|E5|Reported Event|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
218431|NCT01135511|E4|Reported Event|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218432|NCT01135511|E3|Reported Event|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218433|NCT01135511|E2|Reported Event|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218434|NCT01135511|E1|Reported Event|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
218435|NCT01135498|B1|Baseline|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218436|NCT01135498|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218437|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218582|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218438|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218439|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218440|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218441|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218442|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
218443|NCT01135498|E1|Reported Event|Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib|A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.
218444|NCT01135420|B3|Baseline|Total|Total of all reporting groups
218445|NCT01135420|B2|Baseline|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety"
218446|NCT01135420|B1|Baseline|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
218447|NCT01135420|P2|Participant Flow|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
218448|NCT01135420|P1|Participant Flow|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study)."
218449|NCT01135420|O2|Outcome|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
218450|NCT01135420|O1|Outcome|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
218583|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218451|NCT01135420|E2|Reported Event|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
218452|NCT01135420|E1|Reported Event|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
218453|NCT01135381|B5|Baseline|Total|Total of all reporting groups
218454|NCT01135381|B4|Baseline|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218455|NCT01135381|B3|Baseline|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218456|NCT01135381|B2|Baseline|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218457|NCT01135381|B1|Baseline|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218458|NCT01135381|P4|Participant Flow|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218459|NCT01135381|P3|Participant Flow|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218460|NCT01135381|P2|Participant Flow|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218461|NCT01135381|P1|Participant Flow|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218462|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218463|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218464|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218465|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218466|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218467|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218468|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218469|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218584|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218470|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218471|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218472|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218473|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218474|NCT01135381|E4|Reported Event|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
218475|NCT01135381|E3|Reported Event|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218476|NCT01135381|E2|Reported Event|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
218477|NCT01135381|E1|Reported Event|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
218478|NCT01135368|B1|Baseline|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218479|NCT01135368|P1|Participant Flow|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218480|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218481|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218482|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218483|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218484|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218485|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218486|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218487|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218488|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218489|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218490|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218491|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218492|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218493|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218494|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218495|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218496|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218497|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218498|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218499|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218500|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218501|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218502|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218503|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218504|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218505|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218506|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218507|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218508|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218509|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218510|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218511|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218512|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
218513|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
218514|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
218515|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
226008|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
218525|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218526|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
218527|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
218528|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
218529|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
218530|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
218531|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
218532|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
218533|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
218534|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218535|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218536|NCT01135368|O1|Outcome|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
218537|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218538|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
218539|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
218540|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
218541|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
218542|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
218543|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
218544|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
218545|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
218546|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
218547|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
218548|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218549|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218550|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
218551|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
218552|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
218553|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
218554|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
218555|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
218556|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
218557|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
218558|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
218559|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
218560|NCT01135368|O4|Outcome|No Data|Participants with no data at Baseline.
218561|NCT01135368|O3|Outcome|Linear|Participants with linear, chain producing hyperplasia at Baseline.
218562|NCT01135368|O2|Outcome|Simple|Participants with simple (diffuse) hyperplasia at Baseline.
218563|NCT01135368|O1|Outcome|Normal|Participants with normal ECL cell classification at Baseline.
218564|NCT01135368|O5|Outcome|Grade D|Participants with Grade D (mucosal breaks which involve at least 75% of the oesophageal circumference) at Baseline.
218565|NCT01135368|O4|Outcome|Grade C|Participants with Grade C (mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference) at Baseline.
218566|NCT01135368|O3|Outcome|Grade B|Participants with Grade B (one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds) at Baseline.
218567|NCT01135368|O2|Outcome|Grade A|Participants with Grade A (one or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds) at Baseline.
218568|NCT01135368|O1|Outcome|Grade 0|Participants with Grade 0 (normal aspect of mucosa) at Baseline.
218569|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218570|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218571|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218572|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218573|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218574|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218575|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218576|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218577|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218578|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218579|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218585|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218586|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218587|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218588|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218589|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
218590|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
218591|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
218592|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
218593|NCT01135368|E1|Reported Event|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
218594|NCT01135134|B3|Baseline|Total|Total of all reporting groups
218595|NCT01135134|B2|Baseline|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
218596|NCT01135134|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
218597|NCT01135134|P2|Participant Flow|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
218598|NCT01135134|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
218599|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
218600|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
218601|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
218602|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
218603|NCT01135134|E2|Reported Event|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
218604|NCT01135134|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
218605|NCT01135069|B4|Baseline|Total|Total of all reporting groups
218606|NCT01135069|B3|Baseline|Placebo|Microsphere Gel no active
218607|NCT01135069|B2|Baseline|Brand|Retin-A Micro 0.1%
218608|NCT01135069|B1|Baseline|Generic|Tretinoin Microsphere Gel 0.1%
218609|NCT01135069|P3|Participant Flow|Placebo|Microsphere Gel no active
218610|NCT01135069|P2|Participant Flow|Brand|Retin-A Micro 0.1%
218611|NCT01135069|P1|Participant Flow|Generic|Tretinoin Microsphere Gel 0.1%
218612|NCT01135069|O3|Outcome|Placebo|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 58% reduction"
218613|NCT01135069|O2|Outcome|Brand|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 76% reduction"
218614|NCT01135069|O1|Outcome|Generic|"treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 74% reduction."
218615|NCT01135069|E3|Reported Event|Placebo|Microsphere Gel no active
218616|NCT01135069|E2|Reported Event|Brand|Retin-A Micro 0.1%
218617|NCT01135069|E1|Reported Event|Generic|Tretinoin Microsphere Gel 0.1%
218618|NCT01135017|B3|Baseline|Total|Total of all reporting groups
218619|NCT01135017|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218620|NCT01135017|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218621|NCT01135017|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218622|NCT01135017|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218623|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218624|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218625|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218626|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218627|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218628|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218629|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218630|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218631|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218632|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218633|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218634|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
218635|NCT01135017|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
218636|NCT01135017|E1|Reported Event|Placebo|Placebo (for dronedarone) twice a day for 12 weeks
226009|NCT01115673|E3|Reported Event|ACE-0|0 mg Acetaminophen Caplet
218637|NCT01134952|B1|Baseline|MMF MRL Switch|Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
218638|NCT01134952|P1|Participant Flow|MMF SRL Switch|Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
218639|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218640|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218641|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218642|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218643|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218644|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218645|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
218646|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients switched from mycophenolate mofetil to sirolimus
218647|NCT01134952|O1|Outcome|MMF SRL Switch|All patients after switch from mycophenolate to sirolimus
218648|NCT01134952|O1|Outcome|MMF SRL Switch|All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
218649|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
218650|NCT01134952|E1|Reported Event|MMF SRL Switch|All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
218651|NCT01134939|B9|Baseline|Total|Total of all reporting groups
218652|NCT01134939|B8|Baseline|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218653|NCT01134939|B7|Baseline|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218654|NCT01134939|B6|Baseline|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218655|NCT01134939|B5|Baseline|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218656|NCT01134939|B4|Baseline|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218657|NCT01134939|B3|Baseline|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218658|NCT01134939|B2|Baseline|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218659|NCT01134939|B1|Baseline|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218660|NCT01134939|P8|Participant Flow|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218661|NCT01134939|P7|Participant Flow|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218662|NCT01134939|P6|Participant Flow|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218663|NCT01134939|P5|Participant Flow|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218664|NCT01134939|P4|Participant Flow|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218665|NCT01134939|P3|Participant Flow|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218666|NCT01134939|P2|Participant Flow|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218667|NCT01134939|P1|Participant Flow|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218668|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218669|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218670|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218671|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218672|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218673|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218674|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218675|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218676|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218677|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218807|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
218678|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218679|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218680|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218681|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218682|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218683|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218684|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218685|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218686|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218687|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218688|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218689|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218690|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218691|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218692|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218693|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218694|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218695|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218696|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218697|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218698|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218699|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218700|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218701|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218702|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218703|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218704|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218705|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218706|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218707|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218708|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218709|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218710|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218711|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218712|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218713|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218714|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218715|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218716|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218717|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218718|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218719|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218720|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218721|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218722|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218723|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218724|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218725|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218726|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218727|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218728|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218729|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218730|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218731|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218732|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218733|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218734|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218735|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218736|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218737|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218738|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218739|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218740|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218741|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218742|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218743|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218744|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218745|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218746|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218747|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218748|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218749|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218750|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218751|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218752|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218918|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218753|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218754|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218755|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218756|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218757|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218758|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218759|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218760|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218761|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218762|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218763|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218764|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218765|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218766|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218767|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218768|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218769|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218770|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
218771|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
218772|NCT01134939|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
218773|NCT01134939|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
218774|NCT01134939|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
218775|NCT01134939|E1|Reported Event|Treatment-naive Patients|Female and male patients who were not pretreated with HIV therapy.
218776|NCT01134900|B3|Baseline|Total|Total of all reporting groups
218777|NCT01134900|B2|Baseline|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
218778|NCT01134900|B1|Baseline|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
218779|NCT01134900|P2|Participant Flow|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
218780|NCT01134900|P1|Participant Flow|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
218781|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
218782|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
218783|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
218784|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
218785|NCT01134900|E2|Reported Event|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
218786|NCT01134900|E1|Reported Event|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
218787|NCT01134887|B5|Baseline|Total|Total of all reporting groups
218788|NCT01134887|B4|Baseline|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
218808|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
218809|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
218919|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218789|NCT01134887|B3|Baseline|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
218790|NCT01134887|B2|Baseline|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
218791|NCT01134887|B1|Baseline|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
218792|NCT01134887|P4|Participant Flow|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
218793|NCT01134887|P3|Participant Flow|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
218794|NCT01134887|P2|Participant Flow|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
218795|NCT01134887|P1|Participant Flow|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
218796|NCT01134887|O2|Outcome|Arm 2: Control-Veterans|The attention control comparator consisted of giving Veterans a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
218797|NCT01134887|O1|Outcome|Arm 1: Intervention-Veterans|Veterans randomized to the intervention group received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit, an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
218798|NCT01134887|E4|Reported Event|Arm 4: Control-Physicians|Control physicians were told to conduct their encounters as usual and were not given any coaching. Adverse event reporting was provided as part of the study.
218799|NCT01134887|E3|Reported Event|Arm 3: Intervention-Physicians|The 5 intervention arm physicians were coached in the Four Habits of Highly Effective Clinicians in a one hour face to face meeting involving review of the provider's interaction with his or her intervention patients and suggestions for improvement based on these observations.
218800|NCT01134887|E2|Reported Event|Arm 2: Attention Control|Veterans enrolled in the attention control arm received a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
218801|NCT01134887|E1|Reported Event|Arm 1: Intervention|Veterans enrolled in the intervention arm received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
218802|NCT01134783|B3|Baseline|Total|Total of all reporting groups
218803|NCT01134783|B2|Baseline|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
218804|NCT01134783|B1|Baseline|Control Group|This control group arm consists of students who served as the comparison group.
218805|NCT01134783|P2|Participant Flow|Control Group|217 participants were randomized to the control condition
218806|NCT01134783|P1|Participant Flow|Intervention Group|224 participants were randomized to the intervention condition
218810|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
218811|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
218812|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
218813|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
218814|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
218815|NCT01134783|O2|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
218816|NCT01134783|O1|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
218817|NCT01134783|O2|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
218818|NCT01134783|O1|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
218819|NCT01134783|E2|Reported Event|Control Group|This control group consists of students who served as the comparison group.
218820|NCT01134783|E1|Reported Event|Intervention Group|This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
218821|NCT01134731|B4|Baseline|Total|Total of all reporting groups
218822|NCT01134731|B3|Baseline|Placebo 1-5 Capsules|12 weeks
218823|NCT01134731|B2|Baseline|Lithium 600-1500mg|daily
218824|NCT01134731|B1|Baseline|Paliperidone 1-5mg|daily
218825|NCT01134731|P3|Participant Flow|Placebo|1-5 capsules
218826|NCT01134731|P2|Participant Flow|Lithium|"mood stabilizer~dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)"
218827|NCT01134731|P1|Participant Flow|Paliperidone|dose escalation, levels 1-5 daily dosing range from 1-5 mg
218828|NCT01134731|O3|Outcome|Placebo|1-5 placebo capsules
218829|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
218830|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
218831|NCT01134731|O3|Outcome|Placebo|placebo comparator, 1-5 capsules
218832|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
218833|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
218834|NCT01134731|E3|Reported Event|Placebo|
218835|NCT01134731|E2|Reported Event|Lithium|
218836|NCT01134731|E1|Reported Event|Paliperidone|
218837|NCT01134705|B3|Baseline|Total|Total of all reporting groups
218838|NCT01134705|B2|Baseline|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218839|NCT01134705|B1|Baseline|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
218840|NCT01134705|P2|Participant Flow|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218841|NCT01134705|P1|Participant Flow|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
218842|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218843|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
218844|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218845|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
218846|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218847|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
218848|NCT01134705|E2|Reported Event|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
218849|NCT01134705|E1|Reported Event|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
218850|NCT01134627|B3|Baseline|Total|Total of all reporting groups
218851|NCT01134627|B2|Baseline|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218852|NCT01134627|B1|Baseline|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218853|NCT01134627|P2|Participant Flow|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218915|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218854|NCT01134627|P1|Participant Flow|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218855|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218856|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218857|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218858|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218859|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218860|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218861|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218862|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218863|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218864|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218865|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218866|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218867|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218868|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218869|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218870|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218871|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218872|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218873|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218874|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218875|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218876|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218877|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218878|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218879|NCT01134627|E2|Reported Event|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
218916|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218917|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
219177|NCT01133704|B3|Baseline|Total|Total of all reporting groups
218880|NCT01134627|E1|Reported Event|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
218881|NCT01134614|B3|Baseline|Total|Total of all reporting groups
218882|NCT01134614|B2|Baseline|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
218883|NCT01134614|B1|Baseline|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
218884|NCT01134614|P2|Participant Flow|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
218885|NCT01134614|P1|Participant Flow|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
218886|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
218887|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
218888|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
218889|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
218890|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
218891|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
218892|NCT01134614|E2|Reported Event|Arm B (Ipilimumab)|ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
218893|NCT01134614|E1|Reported Event|Arm A (Ipilimumab and Sargramostim)|ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
218894|NCT01134510|B3|Baseline|Total|Total of all reporting groups
218895|NCT01134510|B2|Baseline|Placebo|Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. Then PI will describe the standard of care of Transplant Immunology Program (TIP) patients. After that PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be either emailed or faxed to the patient for review and consideration of study participation. The patient can contact the study team where they will have the opportunity to ask questions and then sign the Informed Consent Form (ICF), if interested.
218896|NCT01134510|B1|Baseline|C1 Esterase Inhibitor|"Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. The PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be emailed or faxed to the patient for review & consideration of study participation. The patient can contact the study team to ask questions and sign the Informed Consent Form (ICF), if interested.~C1 INH is dosed at 20 units per kg body weight and is administered by slow IV injection at a rate of approximately 4 mL per minute. Study patients will receive 20U/kg C1 INH vs placebo (0.9% NS) on days 0 and day 2, then twice weekly X 3 weeks."
218897|NCT01134510|P2|Participant Flow|Placebo|Patients will receive placebo (0.9% Normal Saline) on days 0 and day 2, then twice weekly for 3 weeks.
218898|NCT01134510|P1|Participant Flow|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, Complement 3 and Complement 4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% Normal Saline) on day 0 and day 2, then twice weekly X 3 weeks. A protocol biopsy will be performed at 6 month to assess the allograft for evidence of Antibody Mediated Rejection, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and Anibody Mediated Rejection episodes as well as Donor Specific Antibody. A protocol biopsy will be performed at 6 month.
218899|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
218900|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
218901|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
218902|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
218903|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
218904|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
218905|NCT01134510|O2|Outcome|Normal Saline|"10 subjects placebo in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
218906|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|"10 subjects will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
218907|NCT01134510|E2|Reported Event|C1 Esterase Inhibitor|Total of 1 Serious Adverse Event (1/10 = 10%)
218908|NCT01134510|E1|Reported Event|Placebo|Total of 2 Serious Adverse Events (2/10 patients = 20%)
218909|NCT01134393|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218910|NCT01134393|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218911|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218912|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218913|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218914|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218920|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218921|NCT01134393|E2|Reported Event|T80/A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily
218922|NCT01134393|E1|Reported Event|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
218923|NCT01134315|B3|Baseline|Total|Total of all reporting groups
218924|NCT01134315|B2|Baseline|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218925|NCT01134315|B1|Baseline|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218926|NCT01134315|P2|Participant Flow|Calcitriol|Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218927|NCT01134315|P1|Participant Flow|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218928|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218929|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218930|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218931|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218932|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218933|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218934|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218935|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218936|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218937|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218938|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218939|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218940|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218941|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218942|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218943|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218944|NCT01134315|E2|Reported Event|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
218945|NCT01134315|E1|Reported Event|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
218946|NCT01134276|B3|Baseline|Total|Total of all reporting groups
218947|NCT01134276|B2|Baseline|PTBD|final biliary drainage procedure : biliary drainage via PTBD
218948|NCT01134276|B1|Baseline|ERBD|final biliary drainage procedure: biliary drainage via ERBD/ENBD
218949|NCT01134276|P2|Participant Flow|PTBD|biliary drainage : biliary drainage via PTBD
218950|NCT01134276|P1|Participant Flow|ERBD|biliary drainage : biliary drainage via ERBD/ENBD
218951|NCT01134276|O2|Outcome|ERBD|Final biliary drainage procedure: biliary drainage via ERBD/ENBD
218952|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
218953|NCT01134276|O2|Outcome|ENBD/ERBD|Final biliary drainage procedure: biliary drainage via ENBD/ERBD
218954|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
218955|NCT01134276|O2|Outcome|ERBD|finial biliary drainage procedure: biliary drainage via ERBD or ENBD
218956|NCT01134276|O1|Outcome|PTBD|finial biliary drainage procedure: biliary drainage via PTBD
218957|NCT01134276|E2|Reported Event|ERBD|"final biliary drainage procedure: biliary drainage via ERBD/ENBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
218958|NCT01134276|E1|Reported Event|PTBD|"final biliary drainage procedure: biliary drainage via PTBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
218959|NCT01134107|B3|Baseline|Total|Total of all reporting groups
218960|NCT01134107|B2|Baseline|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
218961|NCT01134107|B1|Baseline|Lispro 6D/Aspart 6D|Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
218962|NCT01134107|P2|Participant Flow|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
218963|NCT01134107|P1|Participant Flow|Lispro 6D/Aspart 6D|Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
218964|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218965|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218966|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218967|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218968|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218969|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218970|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218971|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218972|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218973|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218974|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218975|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218976|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218977|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218978|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218979|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218980|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218981|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218982|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218983|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218984|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218985|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218986|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218987|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218988|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218989|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218990|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218991|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218992|NCT01134107|E2|Reported Event|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
218993|NCT01134107|E1|Reported Event|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
218994|NCT01134042|B4|Baseline|Total|Total of all reporting groups
218995|NCT01134042|B3|Baseline|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
218996|NCT01134042|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
218997|NCT01134042|B1|Baseline|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
218998|NCT01134042|P3|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
218999|NCT01134042|P2|Participant Flow|FF/VI 200/25 µg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219000|NCT01134042|P1|Participant Flow|FF 200 µg OD|Participants received FF 200 microgram (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening plus placebo via the DISKUS/ACCUHALER twice daily (BID), for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219001|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
226010|NCT01115673|E2|Reported Event|ACE-650|650 mg Acetaminophen Caplet
219002|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219003|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219004|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219005|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219006|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219007|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219008|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219009|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219010|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219011|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219012|NCT01134042|O1|Outcome|FF 200 µg OD Arm|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219013|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219014|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219015|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219016|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219017|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219018|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219019|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219020|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219021|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219022|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219023|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219024|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219025|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219026|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219027|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219028|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219029|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219030|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219031|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219032|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219033|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219034|NCT01134042|E3|Reported Event|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219035|NCT01134042|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219036|NCT01134042|E1|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
219037|NCT01134016|B1|Baseline|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
219038|NCT01134016|P1|Participant Flow|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
219039|NCT01134016|O1|Outcome|Tumer Responce at Per-protocol (PP) Population|All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
219040|NCT01134016|O1|Outcome|AUC0-t on Day 28|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
219041|NCT01134016|O1|Outcome|AUC0-t on Day 1|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
219042|NCT01134016|O1|Outcome|Cmax Day 28|the observed maximum plasma concentration after dosing on Day 28
219043|NCT01134016|O1|Outcome|Cmax Day 1|the observed maximum plasma concentration after dosing on Day 1
219044|NCT01134016|O12|Outcome|Half-life Time Day 28: 600mg|The time of plasma concentration drops from maximum to half
219045|NCT01134016|O11|Outcome|Half-life Time Day 28: 450 mg|The time of plasma concentration drops from maximum to half
219046|NCT01134016|O10|Outcome|Half-life Time Day 28: 300 mg|The time of plasma concentration drops from maximum to half
219047|NCT01134016|O9|Outcome|Half-life Time Day 28: 200 mg|The time of plasma concentration drops from maximum to half
219048|NCT01134016|O8|Outcome|Half-life Time Day 28:100 mg|The time of plasma concentration drops from maximum to half
219049|NCT01134016|O7|Outcome|Half-life Time Day 28: 50mg|The time of plasma concentration drops from maximum to half
219050|NCT01134016|O6|Outcome|Half-life Time Day 1: 600 mg|The time of plasma concentration drops from maximum to half
219051|NCT01134016|O5|Outcome|Half-life Time Day 1: 450 mg|The time of plasma concentration drops from maximum to half
219052|NCT01134016|O4|Outcome|Half-life Time Day 1: 300mg|The time of plasma concentration drops from maximum to half
219053|NCT01134016|O3|Outcome|Half-life Time Day 1: 200mg|The time of plasma concentration drops from maximum to half
219054|NCT01134016|O2|Outcome|Half-life Time Day 1: 100 mg|The time of plasma concentration drops from maximum to half
219055|NCT01134016|O1|Outcome|Half-life Time Day 1:50mg|The time of plasma concentration drops from maximum to half
219056|NCT01134016|O12|Outcome|Tmax Day 28: 600mg|Patient represent the time to reach the maximum plasma concentration after dose
219057|NCT01134016|O11|Outcome|Tmax Day 28: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
219058|NCT01134016|O10|Outcome|Tmax Day 28: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
219334|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
219059|NCT01134016|O9|Outcome|Tmax Day 28: 200 mg|Patient represent the time to reach the maximum plasma concentration after dose
219060|NCT01134016|O8|Outcome|Tmax Day 28: 100mg|Patient represent the time to reach the maximum plasma concentration after dose
219061|NCT01134016|O7|Outcome|Tmax Day 28: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
219062|NCT01134016|O6|Outcome|Tmax Day 1 :600 mg|Patient represent the time to reach the maximum plasma concentration after dose
219063|NCT01134016|O5|Outcome|Tmax Day 1: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
219064|NCT01134016|O4|Outcome|Tmax Day 1: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
219065|NCT01134016|O3|Outcome|Tmax Day 1: 200mg|Patient represent the time to reach the maximum plasma concentration after dose
219066|NCT01134016|O2|Outcome|Tmax Day 1: 100 mg|Patient represent the time to reach the maximum plasma concentration after dose
219067|NCT01134016|O1|Outcome|Tmax Day1: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
219068|NCT01134016|O1|Outcome|Antroquinonol|Maximum Tolerable Dose for Antroquinonol
219069|NCT01134016|E1|Reported Event|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
219070|NCT01132846|B4|Baseline|Total|Total of all reporting groups
219071|NCT01132846|B3|Baseline|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219072|NCT01132846|B2|Baseline|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219073|NCT01132846|B1|Baseline|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219074|NCT01132846|P3|Participant Flow|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219075|NCT01132846|P2|Participant Flow|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219076|NCT01132846|P1|Participant Flow|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219077|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219078|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219079|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219080|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219081|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219082|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219083|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219084|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219085|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219086|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219087|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219088|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219089|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219090|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219091|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219092|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219093|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219094|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219095|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219096|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219097|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219098|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219099|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219100|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219101|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219102|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219103|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219104|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219105|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219106|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219107|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219108|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219109|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219335|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
219110|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219111|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219112|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219113|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219114|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219115|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219116|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219117|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219118|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219119|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219120|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219121|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219122|NCT01132846|E3|Reported Event|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
219123|NCT01132846|E2|Reported Event|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
219124|NCT01132846|E1|Reported Event|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
219125|NCT01133977|B6|Baseline|Total|Total of all reporting groups
219126|NCT01133977|B5|Baseline|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219127|NCT01133977|B4|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219128|NCT01133977|B3|Baseline|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219129|NCT01133977|B2|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219130|NCT01133977|B1|Baseline|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219131|NCT01133977|P5|Participant Flow|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219132|NCT01133977|P4|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219336|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
219133|NCT01133977|P3|Participant Flow|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219134|NCT01133977|P2|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219135|NCT01133977|P1|Participant Flow|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219136|NCT01133977|O2|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219137|NCT01133977|O1|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219138|NCT01133977|O5|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219139|NCT01133977|O4|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219140|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219141|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219142|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219143|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219144|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219145|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
219146|NCT01133977|E5|Reported Event|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219147|NCT01133977|E4|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219148|NCT01133977|E3|Reported Event|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219149|NCT01133977|E2|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219150|NCT01133977|E1|Reported Event|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
219151|NCT01133860|B1|Baseline|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219152|NCT01133860|P1|Participant Flow|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219153|NCT01133860|O1|Outcome|Eltrombopag|In patients with more than 100 x10e9 platelets/L at the end of therapy, we evaluated also the in vitro platelet aggregation after stimulation with adenosine diphosphate (5 and 20 mcM), collagen (5 and 20 mg/mL) and ristocetin (3 mg/mL) by the densitometric method of Born in native platelet rich plasma. The extent of platelet aggregation was measured 5 minutes after the addition of stimulating agents and results obtained in patients were compared with the normal ranges in the laboratories where the assay was performed. Results are reported as the number of patients with normal platelet aggregation.
219337|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
219154|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219155|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219156|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219157|NCT01133860|E1|Reported Event|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
219158|NCT01133756|B4|Baseline|Total|Total of all reporting groups
219159|NCT01133756|B3|Baseline|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219160|NCT01133756|B2|Baseline|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219161|NCT01133756|B1|Baseline|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219162|NCT01133756|P3|Participant Flow|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219163|NCT01133756|P2|Participant Flow|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219164|NCT01133756|P1|Participant Flow|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (area under the concentration-time curve [AUC] 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219165|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219166|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219167|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219168|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219169|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219170|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219171|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219172|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219173|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219174|NCT01133756|E3|Reported Event|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219175|NCT01133756|E2|Reported Event|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219176|NCT01133756|E1|Reported Event|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
219178|NCT01133704|B2|Baseline|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
219179|NCT01133704|B1|Baseline|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
219180|NCT01133704|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
219181|NCT01133704|P1|Participant Flow|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
219182|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
219183|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
219184|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
219185|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
219186|NCT01133704|E2|Reported Event|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
219187|NCT01133704|E1|Reported Event|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
219188|NCT01133665|B1|Baseline|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219189|NCT01133665|P1|Participant Flow|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219190|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219191|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219192|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219193|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219194|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219195|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219196|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219197|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219198|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219199|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219200|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219201|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219202|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219297|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219203|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219204|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219205|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219206|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219207|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219208|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219209|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219210|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219211|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219212|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219213|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219214|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219215|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219216|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219217|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219218|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219219|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219220|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219221|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219222|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219223|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219224|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219225|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219226|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219227|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219228|NCT01133665|E1|Reported Event|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
219229|NCT01133626|B4|Baseline|Total|Total of all reporting groups
219260|NCT01133522|P3|Participant Flow|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219230|NCT01133626|B3|Baseline|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
219231|NCT01133626|B2|Baseline|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219232|NCT01133626|B1|Baseline|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219233|NCT01133626|P3|Participant Flow|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
219234|NCT01133626|P2|Participant Flow|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219235|NCT01133626|P1|Participant Flow|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219236|NCT01133626|O3|Outcome|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
219237|NCT01133626|O2|Outcome|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219238|NCT01133626|O1|Outcome|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219239|NCT01133626|E3|Reported Event|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
219240|NCT01133626|E2|Reported Event|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219241|NCT01133626|E1|Reported Event|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
219242|NCT01133522|B11|Baseline|Total|Total of all reporting groups
219243|NCT01133522|B10|Baseline|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219244|NCT01133522|B9|Baseline|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219245|NCT01133522|B8|Baseline|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219246|NCT01133522|B7|Baseline|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219247|NCT01133522|B6|Baseline|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219248|NCT01133522|B5|Baseline|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219249|NCT01133522|B4|Baseline|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219250|NCT01133522|B3|Baseline|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219251|NCT01133522|B2|Baseline|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219252|NCT01133522|B1|Baseline|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219253|NCT01133522|P10|Participant Flow|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219254|NCT01133522|P9|Participant Flow|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219255|NCT01133522|P8|Participant Flow|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219256|NCT01133522|P7|Participant Flow|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219257|NCT01133522|P6|Participant Flow|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.
219258|NCT01133522|P5|Participant Flow|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219259|NCT01133522|P4|Participant Flow|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.
219261|NCT01133522|P2|Participant Flow|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.
219262|NCT01133522|P1|Participant Flow|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219263|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219264|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219265|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219266|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219267|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219268|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219269|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219270|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219271|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219272|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219273|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219274|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219275|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219276|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219277|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219278|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219279|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219280|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219281|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219282|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219283|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219284|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219285|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219286|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219287|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219288|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219289|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219290|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219291|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219292|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219293|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219294|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219295|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219296|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219333|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
219298|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219299|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219300|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219301|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219302|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219303|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219304|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219305|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219306|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219307|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219308|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219309|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219310|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219311|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219312|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219313|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219314|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219315|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219316|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219317|NCT01133522|E10|Reported Event|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219318|NCT01133522|E9|Reported Event|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
219319|NCT01133522|E8|Reported Event|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219320|NCT01133522|E7|Reported Event|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
219321|NCT01133522|E6|Reported Event|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
219322|NCT01133522|E5|Reported Event|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
219323|NCT01133522|E4|Reported Event|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
219324|NCT01133522|E3|Reported Event|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
219325|NCT01133522|E2|Reported Event|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
219326|NCT01133522|E1|Reported Event|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
219327|NCT01133392|B3|Baseline|Total|Total of all reporting groups
219328|NCT01133392|B2|Baseline|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA.
219329|NCT01133392|B1|Baseline|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB.
219330|NCT01133392|P2|Participant Flow|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.
219331|NCT01133392|P1|Participant Flow|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
219332|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
219338|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
219339|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
219340|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
219341|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
219342|NCT01133392|E2|Reported Event|Insulin Lispro B|Insulin lispro B formulation (Treatment B, reference – 2 occasions)
219343|NCT01133392|E1|Reported Event|Insulin Lispro A|Insulin lispro A formulation (Treatment A, test – 2 occasions)
219344|NCT01133379|B4|Baseline|Total|Total of all reporting groups
219345|NCT01133379|B3|Baseline|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219346|NCT01133379|B2|Baseline|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219347|NCT01133379|B1|Baseline|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219348|NCT01133379|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219349|NCT01133379|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219350|NCT01133379|P1|Participant Flow|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219351|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219352|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219353|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219354|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219355|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219356|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219357|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219358|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219359|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219360|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219361|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219362|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219363|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219364|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219365|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219366|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219367|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219368|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219369|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219370|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219371|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219372|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219373|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219374|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219375|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219376|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219377|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219378|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219379|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219380|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219381|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219382|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219383|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219384|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219385|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219386|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219387|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219388|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219389|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219390|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219391|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219392|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219393|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219394|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219395|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219396|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219397|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219398|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219399|NCT01133379|E3|Reported Event|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
219400|NCT01133379|E2|Reported Event|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
219401|NCT01133379|E1|Reported Event|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
219402|NCT01133288|B1|Baseline|Yulex Glove|Yulex Glove Treatment
219403|NCT01133288|P1|Participant Flow|Yulex Glove|Yulex Glove Treatment
219404|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
219405|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
219406|NCT01133288|E1|Reported Event|Yulex Glove|Yulex Glove Treatment
219407|NCT01133275|B1|Baseline|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
219408|NCT01133275|P1|Participant Flow|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
219409|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
219410|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
219411|NCT01133275|E1|Reported Event|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
219412|NCT01133171|B4|Baseline|Total|Total of all reporting groups
219413|NCT01133171|B3|Baseline|Control|
219414|NCT01133171|B2|Baseline|Nurse Alone|
219415|NCT01133171|B1|Baseline|Dashboard Plus Nurse|
219416|NCT01133171|P3|Participant Flow|Control|
219417|NCT01133171|P2|Participant Flow|Nurse Alone|
219418|NCT01133171|P1|Participant Flow|Dashboard Plus Nurse|
219419|NCT01133171|O3|Outcome|Control|
219420|NCT01133171|O2|Outcome|Nurse Alone|
219421|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
219422|NCT01133171|O2|Outcome|Nurse Alone|
219423|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
219424|NCT01133171|E3|Reported Event|Control|
219425|NCT01133171|E2|Reported Event|Nurse Alone|
219426|NCT01133171|E1|Reported Event|Dashboard Plus Nurse|
219427|NCT01132690|B3|Baseline|Total|Total of all reporting groups
219428|NCT01132690|B2|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219429|NCT01132690|B1|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219430|NCT01132690|P2|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219431|NCT01132690|P1|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219432|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219433|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219434|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219435|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219436|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219437|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219438|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219439|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219440|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219441|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219442|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219443|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219444|NCT01132690|E2|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219445|NCT01132690|E1|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
219446|NCT01132664|B6|Baseline|Total|Total of all reporting groups
219447|NCT01132664|B5|Baseline|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219448|NCT01132664|B4|Baseline|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219449|NCT01132664|B3|Baseline|Phase II - 100mg|Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
219450|NCT01132664|B2|Baseline|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219451|NCT01132664|B1|Baseline|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219452|NCT01132664|P5|Participant Flow|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
220306|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
219453|NCT01132664|P4|Participant Flow|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219454|NCT01132664|P3|Participant Flow|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
219455|NCT01132664|P2|Participant Flow|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219456|NCT01132664|P1|Participant Flow|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219457|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219458|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219459|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
219460|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219461|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219462|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219463|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219464|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
219465|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219466|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219467|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219468|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219469|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
219470|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219471|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219472|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219473|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219474|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
219475|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219476|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219477|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219478|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219479|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
219480|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219481|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
219482|NCT01132664|E5|Reported Event|BM Cohort 100 mg/Day|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
219483|NCT01132664|E4|Reported Event|BM Cohort 80 mg/Day|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
219484|NCT01132664|E3|Reported Event|Phase II Dose Expansion 100 mg/Day|Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
219485|NCT01132664|E2|Reported Event|Phase Ib Dose Escalation 100 mg/Day|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
219486|NCT01132664|E1|Reported Event|Phase Ib Dose Escalation 50 mg/Day|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
219487|NCT01132651|B3|Baseline|Total|Total of all reporting groups
219488|NCT01132651|B2|Baseline|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
219489|NCT01132651|B1|Baseline|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
219490|NCT01132651|P2|Participant Flow|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
219491|NCT01132651|P1|Participant Flow|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
219492|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
219493|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
219494|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
219495|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
219496|NCT01132651|E2|Reported Event|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
220307|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
219497|NCT01132651|E1|Reported Event|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
219498|NCT01132547|B3|Baseline|Total|Total of all reporting groups
219499|NCT01132547|B2|Baseline|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219500|NCT01132547|B1|Baseline|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219501|NCT01132547|P2|Participant Flow|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219502|NCT01132547|P1|Participant Flow|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219503|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219504|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219505|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219506|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219507|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219508|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219509|NCT01132547|E2|Reported Event|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
219510|NCT01132547|E1|Reported Event|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
219511|NCT01132508|B1|Baseline|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219512|NCT01132508|P1|Participant Flow|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219513|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219514|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219515|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219516|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219517|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219518|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219519|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219520|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219745|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
226011|NCT01115673|E1|Reported Event|ACE-1000|1000 mg Acetaminophen Caplet
219521|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219522|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219523|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219524|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219525|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219526|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219527|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219528|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219529|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219530|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219531|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219532|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219533|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219534|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219535|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219930|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219536|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219537|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219538|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219539|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219540|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219541|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219542|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219543|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219544|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219545|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219546|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219547|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219548|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219549|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219550|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219931|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
219551|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219552|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219553|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219554|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219555|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219556|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219557|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219558|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219559|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219560|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219561|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219562|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219563|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219564|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219565|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219932|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219566|NCT01132508|E1|Reported Event|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
219567|NCT01132495|B5|Baseline|Total|Total of all reporting groups
219568|NCT01132495|B4|Baseline|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
219569|NCT01132495|B3|Baseline|Cohort B - Follow-up|Observation with treatment based on physician preference
219570|NCT01132495|B2|Baseline|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
219571|NCT01132495|B1|Baseline|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
219572|NCT01132495|P4|Participant Flow|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
219573|NCT01132495|P3|Participant Flow|Cohort B - Follow-up|Observation with treatment based on physician preference
219574|NCT01132495|P2|Participant Flow|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
219575|NCT01132495|P1|Participant Flow|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
219576|NCT01132495|O2|Outcome|Cohort A - OMT Alone|Optimal medical treatment alone - Standard of care: OMT alone
219577|NCT01132495|O1|Outcome|Cohort A - PCI Plus OMT|PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
219578|NCT01132495|E4|Reported Event|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
219579|NCT01132495|E3|Reported Event|Cohort B - Follow-up|Observation with treatment based on physician preference
219580|NCT01132495|E2|Reported Event|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
219581|NCT01132495|E1|Reported Event|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
219582|NCT01132378|B1|Baseline|Median Parepatellar Approach or Minimidvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
219583|NCT01132378|P1|Participant Flow|Mini-midvastus Incision|"Total knee arthroplasty : staged bilateral total knee arthroplasty~Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days."
219584|NCT01132378|O2|Outcome|Mini-midvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
219585|NCT01132378|O1|Outcome|Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
219586|NCT01132378|E1|Reported Event|Midvastus or Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
219587|NCT01132326|B1|Baseline|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
219588|NCT01132326|P1|Participant Flow|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
219589|NCT01132326|O1|Outcome|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
219590|NCT01132326|E1|Reported Event|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
219591|NCT01132313|B13|Baseline|Total|Total of all reporting groups
219592|NCT01132313|B12|Baseline|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219593|NCT01132313|B11|Baseline|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219594|NCT01132313|B10|Baseline|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219595|NCT01132313|B9|Baseline|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219596|NCT01132313|B8|Baseline|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219597|NCT01132313|B7|Baseline|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219598|NCT01132313|B6|Baseline|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219599|NCT01132313|B5|Baseline|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219933|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
219600|NCT01132313|B4|Baseline|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219601|NCT01132313|B3|Baseline|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219602|NCT01132313|B2|Baseline|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219603|NCT01132313|B1|Baseline|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219604|NCT01132313|P12|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219605|NCT01132313|P11|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219606|NCT01132313|P10|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219607|NCT01132313|P9|Participant Flow|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219608|NCT01132313|P8|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219609|NCT01132313|P7|Participant Flow|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219610|NCT01132313|P6|Participant Flow|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219611|NCT01132313|P5|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219612|NCT01132313|P4|Participant Flow|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219613|NCT01132313|P3|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219614|NCT01132313|P2|Participant Flow|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219615|NCT01132313|P1|Participant Flow|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219616|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219617|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219618|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219619|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219620|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219621|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219622|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219623|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219624|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219625|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219626|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219627|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219628|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219629|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219630|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219631|NCT01132313|O7|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219632|NCT01132313|O6|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219633|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219634|NCT01132313|O4|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219635|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219636|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219637|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219638|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219639|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219640|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219641|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219642|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219746|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
220308|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
219643|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219644|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219645|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219646|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219647|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219648|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219649|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219650|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219651|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219652|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219653|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219654|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219655|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219656|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219657|NCT01132313|E12|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219658|NCT01132313|E11|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
219659|NCT01132313|E10|Reported Event|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219660|NCT01132313|E9|Reported Event|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219661|NCT01132313|E8|Reported Event|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219662|NCT01132313|E7|Reported Event|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219663|NCT01132313|E6|Reported Event|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219664|NCT01132313|E5|Reported Event|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
220309|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
219665|NCT01132313|E4|Reported Event|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219666|NCT01132313|E3|Reported Event|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
219667|NCT01132313|E2|Reported Event|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
219668|NCT01132313|E1|Reported Event|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
219669|NCT01132144|B3|Baseline|Total|Total of all reporting groups
219670|NCT01132144|B2|Baseline|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219671|NCT01132144|B1|Baseline|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219672|NCT01132144|P2|Participant Flow|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
219673|NCT01132144|P1|Participant Flow|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219674|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219675|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219676|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219677|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219678|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219679|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219680|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219681|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219682|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219683|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219684|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
219747|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219748|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219685|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219686|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219687|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219688|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219689|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
219690|NCT01132144|E2|Reported Event|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
219691|NCT01132144|E1|Reported Event|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
219692|NCT01132118|B3|Baseline|Total|Total of all reporting groups
219693|NCT01132118|B2|Baseline|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219694|NCT01132118|B1|Baseline|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219695|NCT01132118|P2|Participant Flow|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219696|NCT01132118|P1|Participant Flow|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219697|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219698|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219699|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219700|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219701|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219702|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219703|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219704|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219705|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219706|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219707|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219708|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219709|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
219710|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219711|NCT01132118|E2|Reported Event|Placebo|Participants received Placebo tablets for 8 weeks.
219712|NCT01132118|E1|Reported Event|Hydroxychloroquine|"Participants received hydroxychloroquine (HCQ) for 8 weeks.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
219713|NCT01131884|B3|Baseline|Total|Total of all reporting groups
219714|NCT01131884|B2|Baseline|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
219715|NCT01131884|B1|Baseline|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
219716|NCT01131884|P2|Participant Flow|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
219717|NCT01131884|P1|Participant Flow|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
219718|NCT01131884|O2|Outcome|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
219719|NCT01131884|O1|Outcome|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
219720|NCT01131884|E2|Reported Event|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
219721|NCT01131884|E1|Reported Event|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
219722|NCT01131676|B4|Baseline|Total|Total of all reporting groups
219723|NCT01131676|B3|Baseline|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219724|NCT01131676|B2|Baseline|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219725|NCT01131676|B1|Baseline|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219726|NCT01131676|P3|Participant Flow|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219727|NCT01131676|P2|Participant Flow|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219728|NCT01131676|P1|Participant Flow|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219729|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219730|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219731|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219732|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219733|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219734|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219735|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219736|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219737|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219738|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219739|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219740|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219741|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219742|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219743|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219744|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219749|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219750|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219751|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219752|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219753|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
219754|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219755|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219756|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219757|NCT01131676|E3|Reported Event|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
219758|NCT01131676|E2|Reported Event|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
219759|NCT01131676|E1|Reported Event|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
219760|NCT01131585|B3|Baseline|Total|Total of all reporting groups
219761|NCT01131585|B2|Baseline|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219762|NCT01131585|B1|Baseline|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219763|NCT01131585|P2|Participant Flow|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219764|NCT01131585|P1|Participant Flow|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219765|NCT01131585|O2|Outcome|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219766|NCT01131585|O1|Outcome|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219767|NCT01131585|E2|Reported Event|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219768|NCT01131585|E1|Reported Event|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
219769|NCT01131507|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
219770|NCT01131507|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
219771|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
219772|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
219813|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
219814|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
219815|NCT01131182|E2|Reported Event|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
219773|NCT01131507|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
219774|NCT01131494|B1|Baseline|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
219775|NCT01131494|P1|Participant Flow|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
219776|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
219777|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
219778|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
219779|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
219780|NCT01131494|E1|Reported Event|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
219781|NCT01131455|B4|Baseline|Total|Total of all reporting groups
219782|NCT01131455|B3|Baseline|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
219783|NCT01131455|B2|Baseline|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
219784|NCT01131455|B1|Baseline|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
219785|NCT01131455|P3|Participant Flow|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
219786|NCT01131455|P2|Participant Flow|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
219787|NCT01131455|P1|Participant Flow|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
219788|NCT01131455|O3|Outcome|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
219816|NCT01131182|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
219934|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
226012|NCT01115660|B3|Baseline|Total|Total of all reporting groups
219789|NCT01131455|O2|Outcome|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
219790|NCT01131455|O1|Outcome|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
219791|NCT01131455|E3|Reported Event|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
219792|NCT01131455|E2|Reported Event|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
219793|NCT01131455|E1|Reported Event|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
219794|NCT01131299|B1|Baseline|Alpha Cyclodextrin & Placebo Participants|"Randomized subjects receiving alpha cyclodextrin~Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
219795|NCT01131299|P2|Participant Flow|Alpha Cyclodextrin First, Then Placebo|"Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.~Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks"
219796|NCT01131299|P1|Participant Flow|Placebo First, Then Alpha Cyclodextrin|"Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.~Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks"
219797|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219798|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219799|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219800|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219801|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219802|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219803|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219804|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
219805|NCT01131299|E1|Reported Event|Entire Study Population|"Randomized subjects receiving active comparator~Alpha cyclodextrin: 2g PO 3 times a day for 12-14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
219806|NCT01131182|B3|Baseline|Total|Total of all reporting groups
219807|NCT01131182|B2|Baseline|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
219808|NCT01131182|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
219809|NCT01131182|P2|Participant Flow|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
219810|NCT01131182|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period
219811|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
219812|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
219817|NCT01131130|B1|Baseline|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
219818|NCT01131130|P1|Participant Flow|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
219819|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219820|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219821|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219822|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219823|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219824|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219825|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219826|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219827|NCT01131130|E3|Reported Event|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219828|NCT01131130|E2|Reported Event|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219829|NCT01131130|E1|Reported Event|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
219830|NCT01131078|B4|Baseline|Total|Total of all reporting groups
219831|NCT01131078|B3|Baseline|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219832|NCT01131078|B2|Baseline|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219833|NCT01131078|B1|Baseline|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219834|NCT01131078|P3|Participant Flow|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219835|NCT01131078|P2|Participant Flow|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219836|NCT01131078|P1|Participant Flow|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
219837|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219838|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219839|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219840|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219841|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219842|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219843|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219844|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219845|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219846|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219847|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219848|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219849|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219876|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219850|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219851|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219852|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219853|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219854|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219855|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219856|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219857|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219858|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219859|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219860|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219861|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219862|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219924|NCT01130974|P1|Participant Flow|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219925|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
226643|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
219863|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219864|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219865|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
219866|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219867|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219868|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219869|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219870|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219871|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219872|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219873|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219874|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219875|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219926|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219927|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
219877|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219878|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219879|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219880|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219881|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219882|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219883|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219884|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219885|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219886|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219887|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219888|NCT01131078|E3|Reported Event|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
219889|NCT01131078|E2|Reported Event|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219928|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219929|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
219935|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
219890|NCT01131078|E1|Reported Event|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
219891|NCT01131065|B1|Baseline|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219892|NCT01131065|P1|Participant Flow|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219893|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219894|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219895|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219896|NCT01131065|E1|Reported Event|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
219897|NCT01131052|B3|Baseline|Total|Total of all reporting groups
219898|NCT01131052|B2|Baseline|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219899|NCT01131052|B1|Baseline|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219900|NCT01131052|P2|Participant Flow|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219901|NCT01131052|P1|Participant Flow|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219902|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219903|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219904|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219905|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219906|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219907|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219908|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219909|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219910|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219911|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219912|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219913|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219914|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219915|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219916|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219917|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219918|NCT01131052|E2|Reported Event|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
219919|NCT01131052|E1|Reported Event|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
219920|NCT01130974|B3|Baseline|Total|Total of all reporting groups
219921|NCT01130974|B2|Baseline|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
219922|NCT01130974|B1|Baseline|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219923|NCT01130974|P2|Participant Flow|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
226644|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
219936|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219937|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
219938|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219939|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
219940|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219941|NCT01130974|E2|Reported Event|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
219942|NCT01130974|E1|Reported Event|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
219943|NCT01130883|B1|Baseline|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219944|NCT01130883|P1|Participant Flow|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219945|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219946|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219947|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219948|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219949|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219950|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219951|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219952|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219953|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219954|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219955|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219956|NCT01130883|E1|Reported Event|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
219957|NCT01130844|B4|Baseline|Total|Total of all reporting groups
219958|NCT01130844|B3|Baseline|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219959|NCT01130844|B2|Baseline|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219960|NCT01130844|B1|Baseline|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219961|NCT01130844|P3|Participant Flow|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219962|NCT01130844|P2|Participant Flow|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219963|NCT01130844|P1|Participant Flow|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219964|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
220310|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
219965|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219966|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219967|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219968|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219969|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219970|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219971|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219972|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219973|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219974|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219975|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219976|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219977|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219978|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219979|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219980|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219981|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219982|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219983|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219984|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219985|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219986|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219987|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219988|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219989|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219990|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219991|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219992|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219993|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219994|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219995|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219996|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219997|NCT01130844|E3|Reported Event|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219998|NCT01130844|E2|Reported Event|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
219999|NCT01130844|E1|Reported Event|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
220000|NCT01130831|B1|Baseline|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220001|NCT01130831|P1|Participant Flow|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220002|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220003|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220004|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220005|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220006|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy for >=3 months prior.
220007|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220008|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy of >=3 months of treatment.
220009|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220010|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220011|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220012|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220013|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220014|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220015|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the iPTH KDOQI target on lanthanum carbonate.
220016|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum phosphate KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
220017|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium-phosphorous product KDOQI target on lanthanum carbonate.
220018|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium KDOQI target on lanthanum carbonate.
220019|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum phosphorous KDOQI target on lanthanum carbonate.
220020|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium-phosphorous product levels KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
220021|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium-phosphorous product KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
220022|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
220023|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
220024|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of >=3 months of treatment prior to receiving lanthanum carbonate treatment.
220025|NCT01130831|E1|Reported Event|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
220026|NCT01130740|B3|Baseline|Total|Total of all reporting groups
220027|NCT01130740|B2|Baseline|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220028|NCT01130740|B1|Baseline|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220029|NCT01130740|P2|Participant Flow|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220030|NCT01130740|P1|Participant Flow|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220031|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220032|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220033|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220034|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220052|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220086|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220035|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220036|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220037|NCT01130740|E2|Reported Event|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
220038|NCT01130740|E1|Reported Event|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
220039|NCT01130597|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220040|NCT01130597|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220041|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220042|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220043|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220044|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220045|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220046|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220047|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220048|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220049|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220050|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220051|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220087|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220053|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220054|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220055|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220056|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220057|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220058|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220059|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220060|NCT01130597|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
220061|NCT01130532|B4|Baseline|Total|Total of all reporting groups
220062|NCT01130532|B3|Baseline|Placebo|Placebo for 12 weeks during double-blind treatment period.
220063|NCT01130532|B2|Baseline|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
220064|NCT01130532|B1|Baseline|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
220065|NCT01130532|P4|Participant Flow|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
220066|NCT01130532|P3|Participant Flow|Placebo|Placebo for 12 weeks during double-blind treatment period.
220067|NCT01130532|P2|Participant Flow|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
220068|NCT01130532|P1|Participant Flow|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
220069|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220070|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220071|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220072|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220073|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220074|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220075|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220076|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220077|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
220078|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220079|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220080|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220081|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220082|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220083|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220084|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220085|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220088|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220089|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220090|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220091|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220092|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220093|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220094|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220095|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220096|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220097|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220098|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220099|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220100|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220101|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220102|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220103|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220104|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220105|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
220106|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
220107|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
220108|NCT01130532|E4|Reported Event|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
220109|NCT01130532|E3|Reported Event|Placebo|Placebo for 12 weeks during double-blind treatment period.
220110|NCT01130532|E2|Reported Event|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
220111|NCT01130532|E1|Reported Event|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
220112|NCT01130337|B1|Baseline|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220113|NCT01130337|P1|Participant Flow|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220114|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220115|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220116|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220156|NCT01130168|E3|Reported Event|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220157|NCT01130168|E2|Reported Event|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
220117|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220118|NCT01130337|E1|Reported Event|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
220119|NCT01130168|B1|Baseline|All Participants|
220120|NCT01130168|P6|Participant Flow|Amlodipine/ISMN ER/Placebo (Sequence 6)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
220121|NCT01130168|P5|Participant Flow|Placebo/Amlodipine/ISMN ER (Sequence 5)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
220122|NCT01130168|P4|Participant Flow|ISMN ER/Placebo/Amlodipine (Sequence 4)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
220123|NCT01130168|P3|Participant Flow|Amlodipine/Placebo/ISMN ER (Sequence 3)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
220124|NCT01130168|P2|Participant Flow|ISMN ER/Amlodipine/Placebo (Sequence 2)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
220125|NCT01130168|P1|Participant Flow|Placebo/ISMN ER/Amlodipine (Sequence 1)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo
220126|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220127|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220128|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220129|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220130|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220131|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220132|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220133|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220134|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220135|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220136|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220137|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220138|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220139|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220140|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220141|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220142|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220143|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220144|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220145|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220146|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220147|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220148|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220149|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220150|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220151|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220152|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
220153|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220154|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
220155|NCT01130168|O1|Outcome|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
220158|NCT01130168|E1|Reported Event|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
220159|NCT01130103|B3|Baseline|Total|Total of all reporting groups
220160|NCT01130103|B2|Baseline|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220161|NCT01130103|B1|Baseline|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220162|NCT01130103|P2|Participant Flow|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220163|NCT01130103|P1|Participant Flow|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220164|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220165|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220166|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220167|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220168|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220169|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220170|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220171|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220172|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220173|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220174|NCT01130103|E2|Reported Event|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
220175|NCT01130103|E1|Reported Event|Paroxetine|Paroxetine and Prolonged Exposure Therapy
220176|NCT01130051|B1|Baseline|Colcrys® Intact Tab and Colcrys® in Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
220177|NCT01130051|P2|Participant Flow|Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
220178|NCT01130051|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
220179|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
220180|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
220181|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
220182|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
220183|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
220184|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
220185|NCT01130051|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
220186|NCT01130051|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
220187|NCT01129960|B5|Baseline|Total|Total of all reporting groups
220188|NCT01129960|B4|Baseline|Placebo|Placebo: Tablets will be used.
220189|NCT01129960|B3|Baseline|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220190|NCT01129960|B2|Baseline|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220191|NCT01129960|B1|Baseline|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
220192|NCT01129960|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
220193|NCT01129960|P3|Participant Flow|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220194|NCT01129960|P2|Participant Flow|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220195|NCT01129960|P1|Participant Flow|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
220196|NCT01129960|O4|Outcome|Placebo|Placebo: Tablets will be used.
220197|NCT01129960|O3|Outcome|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220198|NCT01129960|O2|Outcome|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220199|NCT01129960|O1|Outcome|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
220200|NCT01129960|E4|Reported Event|Placebo|Placebo: Tablets will be used.
220201|NCT01129960|E3|Reported Event|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220202|NCT01129960|E2|Reported Event|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
220203|NCT01129960|E1|Reported Event|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
220205|NCT01129921|B2|Baseline|Sham Procedure|Group 2: sham decompression with trocar placement and no bone or tissue removal
220206|NCT01129921|B1|Baseline|Mild Procedure|Group 1: mild percutaneous decompression with removal of bone and tissue
220207|NCT01129921|P2|Participant Flow|Sham Then Percutaneous Decompression With Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
220208|NCT01129921|P1|Participant Flow|Percutaneous Decompression Procedure Only|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
220209|NCT01129921|O2|Outcome|Sham Then Percutaneous Decompression With Mild|Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
220210|NCT01129921|O1|Outcome|Percutaneous Decompression Procedure Only|Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
220211|NCT01129921|O2|Outcome|Sham Group 2 Year-1 Cohort After X-over to Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
220212|NCT01129921|O1|Outcome|Mild Group 1 Year-1 Cohort|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
220213|NCT01129921|O2|Outcome|Sham Procedure Group 2 Prior to Cross-over|Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
220214|NCT01129921|O1|Outcome|Mild Procedure Group 1|Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.
220215|NCT01129921|E2|Reported Event|Sham Procedure With Optional Crossover to Mild Post-unblinding|Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
220216|NCT01129921|E1|Reported Event|Mild Procedure|percutaneous decompression with bone and tissue removal
220217|NCT01129765|B1|Baseline|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220218|NCT01129765|P1|Participant Flow|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220219|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220220|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220221|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220222|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220223|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220224|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220225|NCT01129765|E1|Reported Event|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
220226|NCT01129622|B1|Baseline|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
220227|NCT01129622|P1|Participant Flow|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
220228|NCT01129622|O1|Outcome|Adverse Events|Hypo-estrogenic side effects
220229|NCT01129622|O1|Outcome|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
220230|NCT01129622|E1|Reported Event|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
220231|NCT01129583|B3|Baseline|Total|Total of all reporting groups
220232|NCT01129583|B2|Baseline|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220233|NCT01129583|B1|Baseline|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220234|NCT01129583|P2|Participant Flow|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220235|NCT01129583|P1|Participant Flow|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220236|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220237|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220238|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220239|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220311|NCT01129557|O3|Outcome|Tekturna + Diovan|aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
220240|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220241|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220242|NCT01129583|E2|Reported Event|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220243|NCT01129583|E1|Reported Event|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
220244|NCT01129557|B4|Baseline|Total|Total of all reporting groups
220245|NCT01129557|B3|Baseline|Tekturna+Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
220246|NCT01129557|B2|Baseline|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
220247|NCT01129557|B1|Baseline|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
220248|NCT01129557|P3|Participant Flow|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
220249|NCT01129557|P2|Participant Flow|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
220250|NCT01129557|P1|Participant Flow|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
220251|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220252|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220253|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220254|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220255|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220256|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220257|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220258|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220259|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220260|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220261|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220262|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220263|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220264|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220265|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220266|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220267|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220268|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220269|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220270|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220271|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220272|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220273|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220274|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220275|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
220276|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220277|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
220278|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220279|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
220280|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
220281|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
220282|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220283|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
220284|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
220285|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
220286|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220287|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
220288|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
220289|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
220290|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220291|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
220292|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
220293|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
220294|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220295|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
220296|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
220297|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
220298|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
220299|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
220300|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
220301|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
220302|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
220303|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
220304|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
220305|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
220312|NCT01129557|O2|Outcome|Tekturna|aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
220313|NCT01129557|O1|Outcome|Diovan|valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
220314|NCT01129557|E3|Reported Event|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
220315|NCT01129557|E2|Reported Event|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
220316|NCT01129557|E1|Reported Event|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
220317|NCT01129531|B4|Baseline|Total|Total of all reporting groups
220318|NCT01129531|B3|Baseline|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
220319|NCT01129531|B2|Baseline|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220320|NCT01129531|B1|Baseline|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220321|NCT01129531|P3|Participant Flow|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
220322|NCT01129531|P2|Participant Flow|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220323|NCT01129531|P1|Participant Flow|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220324|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
220325|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220326|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220327|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Participants received two treatments 12 weeks apart.
220328|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220329|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220330|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
220331|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220332|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220333|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
220334|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
220335|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
220336|NCT01129531|E6|Reported Event|Placebo_Cycle 2|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
220337|NCT01129531|E5|Reported Event|AGN-214868 16.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
220338|NCT01129531|E4|Reported Event|AGN-214868 3.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
220339|NCT01129531|E3|Reported Event|Placebo_Cycle 1|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
220340|NCT01129531|E2|Reported Event|AGN-214868 16.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
220341|NCT01129531|E1|Reported Event|AGN-214868 3.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
220342|NCT01129336|B3|Baseline|Total|Total of all reporting groups
220343|NCT01129336|B2|Baseline|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220344|NCT01129336|B1|Baseline|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220345|NCT01129336|P2|Participant Flow|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220346|NCT01129336|P1|Participant Flow|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220347|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220348|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220349|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220350|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220351|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220352|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220353|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220354|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220355|NCT01129336|E2|Reported Event|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
220356|NCT01129336|E1|Reported Event|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
220357|NCT01129284|B4|Baseline|Total|Total of all reporting groups
220358|NCT01129284|B3|Baseline|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease)
220359|NCT01129284|B2|Baseline|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
220360|NCT01129284|B1|Baseline|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy
220361|NCT01129284|P3|Participant Flow|Immunoglobulin A (IgA) Nephropathy|Subjects diagnosed with Immunoglobulin A (IgA) nephropathy (Berger's disease) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
220362|NCT01129284|P2|Participant Flow|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
220363|NCT01129284|P1|Participant Flow|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
220364|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220365|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220366|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220367|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220368|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220369|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220370|NCT01129284|E3|Reported Event|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220371|NCT01129284|E2|Reported Event|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220372|NCT01129284|E1|Reported Event|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
220373|NCT01129245|B3|Baseline|Total|Total of all reporting groups
220374|NCT01129245|B2|Baseline|Celecoxib First, Then Placebo|control menstrual cycle, celecoxib menstrual cycle, placebo menstrual cycle
220375|NCT01129245|B1|Baseline|Placebo First, Then Celecoxib|control menstrual cycle, placebo menstrual cycle, and then celecoxib menstrual cycle
220376|NCT01129245|P2|Participant Flow|Celecoxib First, Then Placebo|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
220377|NCT01129245|P1|Participant Flow|Placebo First, Then Celecoxib|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
220378|NCT01129245|O2|Outcome|Placebo|received placebo during menstrual cycle
220379|NCT01129245|O1|Outcome|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
220380|NCT01129245|E2|Reported Event|Placebo|received placebo drug
220381|NCT01129245|E1|Reported Event|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
220382|NCT01129206|B1|Baseline|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220383|NCT01129206|P1|Participant Flow|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220384|NCT01129206|O2|Outcome|RECIST Criteria Per CT|
220385|NCT01129206|O1|Outcome|PERCIST Criteria Per PET|
220386|NCT01129206|O1|Outcome|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220414|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220387|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220388|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220389|NCT01129206|E1|Reported Event|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
220390|NCT01129141|B3|Baseline|Total|Total of all reporting groups
220391|NCT01129141|B2|Baseline|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
220392|NCT01129141|B1|Baseline|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
220393|NCT01129141|P2|Participant Flow|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
220394|NCT01129141|P1|Participant Flow|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
220395|NCT01129141|O2|Outcome|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
220396|NCT01129141|O1|Outcome|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
220397|NCT01129141|E2|Reported Event|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
220398|NCT01129141|E1|Reported Event|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
220399|NCT01129128|B4|Baseline|Total|Total of all reporting groups
220400|NCT01129128|B3|Baseline|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220401|NCT01129128|B2|Baseline|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220402|NCT01129128|B1|Baseline|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220403|NCT01129128|P3|Participant Flow|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220404|NCT01129128|P2|Participant Flow|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220405|NCT01129128|P1|Participant Flow|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220406|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220407|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220408|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220409|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220410|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220411|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220412|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220413|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220415|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220416|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220417|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220418|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220419|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220420|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220421|NCT01129128|E3|Reported Event|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
220422|NCT01129128|E2|Reported Event|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
220423|NCT01129128|E1|Reported Event|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
220424|NCT01129115|B5|Baseline|Total|Total of all reporting groups
220425|NCT01129115|B4|Baseline|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220426|NCT01129115|B3|Baseline|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220427|NCT01129115|B2|Baseline|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220428|NCT01129115|B1|Baseline|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220429|NCT01129115|P4|Participant Flow|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220430|NCT01129115|P3|Participant Flow|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220431|NCT01129115|P2|Participant Flow|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220432|NCT01129115|P1|Participant Flow|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220433|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220434|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220435|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220436|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220437|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220438|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220439|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220440|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220441|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220442|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220443|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220444|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220445|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220446|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220447|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220448|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220449|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220450|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220451|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220452|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220453|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220454|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220455|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220456|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220457|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220458|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220459|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220460|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220461|NCT01129115|E4|Reported Event|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
220462|NCT01129115|E3|Reported Event|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
220463|NCT01129115|E2|Reported Event|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
220464|NCT01129115|E1|Reported Event|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
220465|NCT01129102|B4|Baseline|Total|Total of all reporting groups
220466|NCT01129102|B3|Baseline|Placebo|Placebo for NPC-01
220467|NCT01129102|B2|Baseline|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
220468|NCT01129102|B1|Baseline|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
220469|NCT01129102|P3|Participant Flow|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
220470|NCT01129102|P2|Participant Flow|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
220471|NCT01129102|P1|Participant Flow|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
220472|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
220473|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
220474|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
220475|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
220476|NCT01129102|E3|Reported Event|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
220477|NCT01129102|E2|Reported Event|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
220478|NCT01129102|E1|Reported Event|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
220479|NCT01129011|B3|Baseline|Total|Total of all reporting groups
220480|NCT01129011|B2|Baseline|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220481|NCT01129011|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220482|NCT01129011|P2|Participant Flow|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220483|NCT01129011|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220484|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220485|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220486|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220487|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220488|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220489|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220490|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220491|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220492|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220493|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220494|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220495|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220496|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220497|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220498|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220499|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220500|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220501|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220502|NCT01129011|E2|Reported Event|Naproxen|Naproxen 500 mg dosed twice daily (bid)
220503|NCT01129011|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
220504|NCT01128972|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
220505|NCT01128972|P5|Participant Flow|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220506|NCT01128972|P4|Participant Flow|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220507|NCT01128972|P3|Participant Flow|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220508|NCT01128972|P2|Participant Flow|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220509|NCT01128972|P1|Participant Flow|Test Dentifrice + Test Mouth Rinse (MR)|Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220510|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220511|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220512|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220540|NCT01128959|O1|Outcome|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
220513|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220514|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220515|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220516|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220517|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220518|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220519|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220520|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220521|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220522|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220523|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220524|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220525|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220526|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220527|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220528|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220529|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220530|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220531|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220532|NCT01128972|E5|Reported Event|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220533|NCT01128972|E4|Reported Event|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220534|NCT01128972|E3|Reported Event|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220535|NCT01128972|E2|Reported Event|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
220536|NCT01128972|E1|Reported Event|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
220537|NCT01128959|B1|Baseline|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
220538|NCT01128959|P1|Participant Flow|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
220539|NCT01128959|O2|Outcome|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
226645|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
220541|NCT01128959|E2|Reported Event|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|
220542|NCT01128959|E1|Reported Event|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|
220543|NCT01128946|B1|Baseline|Overall|All randomized participants
220544|NCT01128946|P4|Participant Flow|NaF Toothpaste (675ppmF|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220545|NCT01128946|P3|Participant Flow|Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220546|NCT01128946|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
220547|NCT01128946|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220548|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220549|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220550|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220551|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220552|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220553|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220554|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220555|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220556|NCT01128946|O2|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220557|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220558|NCT01128946|E4|Reported Event|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220559|NCT01128946|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220560|NCT01128946|E2|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220561|NCT01128946|E1|Reported Event|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
220562|NCT01128894|B3|Baseline|Total|Total of all reporting groups
220563|NCT01128894|B2|Baseline|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220564|NCT01128894|B1|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220565|NCT01128894|P2|Participant Flow|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220566|NCT01128894|P1|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220567|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220568|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220569|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220570|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220571|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220572|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220573|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220574|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220575|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220576|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220577|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220578|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220579|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220580|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220581|NCT01128894|E2|Reported Event|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
220582|NCT01128894|E1|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
220583|NCT01128829|B1|Baseline|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
220584|NCT01128829|P2|Participant Flow|"Sucralose Then Water"|"First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load."
220585|NCT01128829|P1|Participant Flow|"Water Then Sucralose"|"First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load."
220586|NCT01128829|O1|Outcome|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
220829|NCT01128270|E2|Reported Event|Chloral Hydrate (Environmental)|This is Period 2. See description of periods for full details.
220587|NCT01128829|E1|Reported Event|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
220588|NCT01128738|B3|Baseline|Total|Total of all reporting groups
220589|NCT01128738|B2|Baseline|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220590|NCT01128738|B1|Baseline|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220591|NCT01128738|P2|Participant Flow|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220592|NCT01128738|P1|Participant Flow|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220593|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220594|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220595|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220596|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220597|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220598|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220599|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220717|NCT01128595|P2|Participant Flow|Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg|Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
220600|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220601|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220602|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220603|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220604|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220605|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220606|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220607|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220608|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220609|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220610|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220611|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220612|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220613|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220830|NCT01128270|E1|Reported Event|1A: Chloral Hydrate+DCA (Environmental)|This is Period 1. See description of periods for full details.
220614|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220615|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220616|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220617|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220618|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220619|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220620|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220621|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220622|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220623|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220624|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220625|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220626|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220718|NCT01128595|P1|Participant Flow|Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
220627|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220628|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220629|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220630|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220631|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220632|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220633|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220634|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220635|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220636|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220637|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220638|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220639|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220640|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220889|NCT01128179|E2|Reported Event|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220641|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220642|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220643|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220644|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220645|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220646|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220647|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220648|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220649|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220650|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220651|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220652|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220653|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220719|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220720|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220654|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220655|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220656|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220657|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220658|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220659|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220660|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220661|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
220662|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220663|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220664|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220665|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220721|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220722|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220666|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220667|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220668|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220669|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220670|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220671|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220672|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220673|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220674|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220675|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220723|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220676|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220677|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220678|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220679|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220680|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220681|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220682|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220683|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220684|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220685|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220724|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220686|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220687|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220688|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220689|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220690|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220691|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220692|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220693|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220694|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220695|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220725|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220696|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220697|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220698|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220699|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220700|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220701|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220702|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220703|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220704|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220705|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220726|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220706|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220707|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220708|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220709|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220710|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220711|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220712|NCT01128738|E2|Reported Event|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220713|NCT01128738|E1|Reported Event|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
220714|NCT01128595|B1|Baseline|Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg|All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
220715|NCT01128595|P4|Participant Flow|Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
220716|NCT01128595|P3|Participant Flow|Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
226646|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
220727|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220728|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220729|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220730|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220731|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220732|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220733|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220734|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220735|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220736|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220737|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220738|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220739|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220740|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220741|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220742|NCT01128595|O1|Outcome|Placebo|
220743|NCT01128595|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220744|NCT01128595|E3|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220745|NCT01128595|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220746|NCT01128595|E1|Reported Event|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
220747|NCT01128569|B1|Baseline|Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220748|NCT01128569|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo|Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220749|NCT01128569|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg|Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220750|NCT01128569|P4|Participant Flow|Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg|Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220751|NCT01128569|P3|Participant Flow|Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220752|NCT01128569|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
222528|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
220753|NCT01128569|P1|Participant Flow|Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220754|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220755|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220756|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220757|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220758|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220759|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220760|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220761|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220762|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220763|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220764|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220765|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220766|NCT01128569|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220767|NCT01128569|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
220768|NCT01128569|E1|Reported Event|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
220769|NCT01128543|B1|Baseline|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220770|NCT01128543|P1|Participant Flow|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220771|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220772|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220773|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220774|NCT01128543|E1|Reported Event|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
220775|NCT01128426|B1|Baseline|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220791|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220776|NCT01128426|P1|Participant Flow|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220777|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220778|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220779|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220780|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220781|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220782|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220783|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220784|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220785|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220786|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220787|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220788|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220789|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220790|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
220828|NCT01128270|E3|Reported Event|Chloral Hydrate +DCA (Therapeutic Dose)|This is Period 3. See description of periods for full details.
220792|NCT01128426|E1|Reported Event|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
220793|NCT01128413|B3|Baseline|Total|Total of all reporting groups
220794|NCT01128413|B2|Baseline|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
220795|NCT01128413|B1|Baseline|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
220796|NCT01128413|P2|Participant Flow|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
220797|NCT01128413|P1|Participant Flow|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
220798|NCT01128413|O2|Outcome|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
220799|NCT01128413|O1|Outcome|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
220800|NCT01128413|E2|Reported Event|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
220801|NCT01128413|E1|Reported Event|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
220802|NCT01128400|B4|Baseline|Total|Total of all reporting groups
220803|NCT01128400|B3|Baseline|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
220804|NCT01128400|B2|Baseline|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
220805|NCT01128400|B1|Baseline|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
220806|NCT01128400|P3|Participant Flow|rs1761667-AG Genotype|Heterozygous of CD36 gene rs1761667-A genotype.
220807|NCT01128400|P2|Participant Flow|rs1761667-GG Genotype|subjects who are homozygous of CD36 genotype rs1761667-G allele.
220808|NCT01128400|P1|Participant Flow|rs1761667- AA Genotype|subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
220809|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
220810|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
220811|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
220812|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
220813|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
220814|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
220815|NCT01128400|E3|Reported Event|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
220816|NCT01128400|E2|Reported Event|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
220817|NCT01128400|E1|Reported Event|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
220818|NCT01128270|B1|Baseline|All Subjects|Intent was to have all subjects participate in all sessions (periods)
220819|NCT01128270|P1|Participant Flow|All Subjects|The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.
220820|NCT01128270|O4|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
220821|NCT01128270|O3|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
220822|NCT01128270|O2|Outcome|Environmental Chloral Hydrate (1B)|Arm 1B: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights). Pharmacokinetics are done on days 1 and 5.
220823|NCT01128270|O1|Outcome|Environmental Chloral Hydrate and DCA (1A)|Arm 1A: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights) and environmental Dichloroacetate on Day 1 (2.5 mcg/Kg.)pharmacokinetics are done on days 1 and 5.
220824|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
220825|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
220826|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5. This outcome only applies to Period 3.
220827|NCT01128270|E4|Reported Event|Chloral Hydrate (Therapeutic Dose)|This is Period 4 See description of periods for full details.
220831|NCT01128244|B1|Baseline|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
220832|NCT01128244|P1|Participant Flow|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
220833|NCT01128244|O1|Outcome|Secondary Analysis: Plasma 3-hydroxykynurenine Concentration|Plasma 3-hydroxykynurenine concentration will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
220834|NCT01128244|O1|Outcome|Plasma Cystathionine Concentration|Plasma cystathionine will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
220835|NCT01128244|O1|Outcome|Plasma Pyridoxal Phosphate Concentration|Plasma PLP will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
220836|NCT01128244|O1|Outcome|Homocysteine Remethylation Flux From Serine|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
220837|NCT01128244|O1|Outcome|Total Homocysteine Remethylation Flux|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
220838|NCT01128244|E1|Reported Event|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
220839|NCT01128192|B3|Baseline|Total|Total of all reporting groups
220840|NCT01128192|B2|Baseline|Pasireotide 900 μg sc Bid|Pasireotide 900 μg sc bid n=19
220841|NCT01128192|B1|Baseline|Pasireotide 600 μg sc Bid|Pasireotide 600 μg sc bid n=19
220842|NCT01128192|P3|Participant Flow|Pasireotide 1200 μg sc Bid|7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.
220843|NCT01128192|P2|Participant Flow|Pasireotide 900 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.
220844|NCT01128192|P1|Participant Flow|Pasireotide 600 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.
220845|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220846|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220847|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220848|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220849|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220850|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220851|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220852|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220853|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220854|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
220855|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
220856|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
220857|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
220858|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
220859|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220860|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220861|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220862|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220863|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220864|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220865|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220866|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
220867|NCT01128192|E3|Reported Event|Pasireotide 1200 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
220868|NCT01128192|E2|Reported Event|Pasireotide 900 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
220869|NCT01128192|E1|Reported Event|Pasireotide 600 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
220870|NCT01128179|B3|Baseline|Total|Total of all reporting groups
220871|NCT01128179|B2|Baseline|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220872|NCT01128179|B1|Baseline|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220873|NCT01128179|P2|Participant Flow|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220874|NCT01128179|P1|Participant Flow|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220875|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220876|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220877|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220878|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220879|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220880|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220881|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220882|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220883|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220884|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220885|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220886|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220887|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
220888|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220890|NCT01128179|E1|Reported Event|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
220891|NCT01128153|B3|Baseline|Total|Total of all reporting groups
220892|NCT01128153|B2|Baseline|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220893|NCT01128153|B1|Baseline|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220894|NCT01128153|P2|Participant Flow|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220895|NCT01128153|P1|Participant Flow|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220896|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220897|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220898|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220899|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220900|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220901|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220902|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220903|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220904|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220905|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220906|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220907|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220908|NCT01128153|E2|Reported Event|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
220909|NCT01128153|E1|Reported Event|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
220910|NCT01128114|B1|Baseline|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
220911|NCT01128114|P1|Participant Flow|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
220912|NCT01128114|O1|Outcome|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
220913|NCT01128114|E1|Reported Event|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
220914|NCT01128049|B4|Baseline|Total|Total of all reporting groups
220915|NCT01128049|B3|Baseline|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
220916|NCT01128049|B2|Baseline|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
220917|NCT01128049|B1|Baseline|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
220918|NCT01128049|P3|Participant Flow|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
220919|NCT01128049|P2|Participant Flow|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
220920|NCT01128049|P1|Participant Flow|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
220921|NCT01128049|O3|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
220922|NCT01128049|O2|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.
220923|NCT01128049|O1|Outcome|Normal|Normal group included non-dry eye subjects.
220924|NCT01128049|E3|Reported Event|ADDE Population|Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
220925|NCT01128049|E2|Reported Event|MGD Patient Population|Meibomium Gland Dysfunction population(intervention remains the same across all arms)
220926|NCT01128049|E1|Reported Event|Normal Patient Population|Non-Dry Eye patient population (intervention remains the same across all arms)
220927|NCT01127763|B1|Baseline|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
220928|NCT01127763|P1|Participant Flow|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
220929|NCT01127763|O1|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
220930|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
220931|NCT01127763|O3|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
220932|NCT01127763|O2|Outcome|RAD001+Carboplatin (AUC 4)|Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
220933|NCT01127763|O1|Outcome|RAD001+Carboplatin (AUC 6 and 5)|Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
220934|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
221004|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
220935|NCT01127763|E1|Reported Event|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
220936|NCT01127737|B3|Baseline|Total|Total of all reporting groups
220937|NCT01127737|B2|Baseline|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
220938|NCT01127737|B1|Baseline|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
220939|NCT01127737|P2|Participant Flow|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
220940|NCT01127737|P1|Participant Flow|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
220941|NCT01127737|O2|Outcome|Placebo|
220942|NCT01127737|O1|Outcome|Intervention|Educational intervention consisting of a mnemonic and a workboook
220943|NCT01127737|E2|Reported Event|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
220944|NCT01127737|E1|Reported Event|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
220945|NCT01127646|B3|Baseline|Total|Total of all reporting groups
220946|NCT01127646|B2|Baseline|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220947|NCT01127646|B1|Baseline|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220948|NCT01127646|P2|Participant Flow|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220949|NCT01127646|P1|Participant Flow|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220950|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
220951|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
220952|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
220953|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
220954|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220955|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220956|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220957|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220958|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220959|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220960|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220961|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220962|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220963|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220964|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
220965|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
220966|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220967|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220968|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220969|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220970|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220971|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220972|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220973|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220974|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220975|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220976|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220977|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
220978|NCT01127646|E2|Reported Event|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
220979|NCT01127646|E1|Reported Event|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
220980|NCT01127607|B3|Baseline|Total|Total of all reporting groups
220981|NCT01127607|B2|Baseline|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
220982|NCT01127607|B1|Baseline|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
220983|NCT01127607|P2|Participant Flow|Treatment Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
220984|NCT01127607|P1|Participant Flow|Placebo Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II.
220985|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
220986|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
220987|NCT01127607|O4|Outcome|70 mg Lisdexamfetamine|This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
220988|NCT01127607|O3|Outcome|50 mg Lisdexamfetamine|This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
220989|NCT01127607|O2|Outcome|30 mg Lisdexamfetamine|This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
220990|NCT01127607|O1|Outcome|No Medication|The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
220991|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
220992|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
220993|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220994|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220995|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220996|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220997|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220998|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
220999|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221000|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221001|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221002|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221003|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221005|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221006|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221007|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221008|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221009|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221010|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221011|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
221012|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
221013|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221014|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221015|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221016|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221017|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221018|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221019|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221020|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221021|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
221022|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
221023|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
221024|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
221025|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221026|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221027|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221028|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221029|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
221030|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
221031|NCT01127607|O2|Outcome|Optimal Dose of Medication|Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
221032|NCT01127607|O1|Outcome|Unmedicated|baseline; participants not on medication
221033|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221034|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221035|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221036|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221037|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221038|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221039|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221040|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
221041|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
221042|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
221043|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
221044|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
221045|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
221046|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
221047|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
221048|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
221049|NCT01127607|E5|Reported Event|All Participants in Period 1 Prescribed 70mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~17 of 36 participants were dispensed the 70mg dose."
221050|NCT01127607|E4|Reported Event|All Participants in Period 1 Prescribed 50mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~21 of 36 participants were dispensed the 50mg dose."
221051|NCT01127607|E3|Reported Event|All Participants in Period 1 Prescribed 30mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category."
221052|NCT01127607|E2|Reported Event|Treatment Arm|subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).
221053|NCT01127607|E1|Reported Event|Placebo Arm|subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects.
221054|NCT01127581|B3|Baseline|Total|Total of all reporting groups
221055|NCT01127581|B2|Baseline|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221056|NCT01127581|B1|Baseline|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221057|NCT01127581|P2|Participant Flow|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221058|NCT01127581|P1|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221059|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221060|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221061|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221062|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221063|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221064|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221065|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221066|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221067|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221068|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221069|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221070|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221071|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221072|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221073|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221074|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221075|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221076|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221077|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221078|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221079|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221134|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221135|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221080|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221081|NCT01127581|E2|Reported Event|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221082|NCT01127581|E1|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
221083|NCT01127438|B7|Baseline|Total|Total of all reporting groups
221084|NCT01127438|B6|Baseline|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221085|NCT01127438|B5|Baseline|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221086|NCT01127438|B4|Baseline|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221087|NCT01127438|B3|Baseline|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221088|NCT01127438|B2|Baseline|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221089|NCT01127438|B1|Baseline|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221090|NCT01127438|P6|Participant Flow|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
221091|NCT01127438|P5|Participant Flow|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day).
221092|NCT01127438|P4|Participant Flow|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day).
221093|NCT01127438|P3|Participant Flow|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
221094|NCT01127438|P2|Participant Flow|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day).
221095|NCT01127438|P1|Participant Flow|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day).
221096|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221097|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221098|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221099|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221100|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221101|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221102|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221103|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221104|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221105|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221106|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221107|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221108|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221109|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221110|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221111|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221112|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
221113|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
221114|NCT01127438|E2|Reported Event|Approved Dose|Includes subgroups 1-3
221115|NCT01127438|E1|Reported Event|Lower Dose|Includes subgroups 1-3
221116|NCT01127321|B6|Baseline|Total|Total of all reporting groups
221117|NCT01127321|B5|Baseline|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221118|NCT01127321|B4|Baseline|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221119|NCT01127321|B3|Baseline|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221120|NCT01127321|B2|Baseline|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221121|NCT01127321|B1|Baseline|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221122|NCT01127321|P5|Participant Flow|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221123|NCT01127321|P4|Participant Flow|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221124|NCT01127321|P3|Participant Flow|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221125|NCT01127321|P2|Participant Flow|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221126|NCT01127321|P1|Participant Flow|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221127|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221128|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221129|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221130|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221131|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221132|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221133|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221209|NCT01126801|E1|Reported Event|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
221136|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221137|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221138|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221139|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221140|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221141|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221142|NCT01127321|E5|Reported Event|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
221143|NCT01127321|E4|Reported Event|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
221144|NCT01127321|E3|Reported Event|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
221145|NCT01127321|E2|Reported Event|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
221146|NCT01127321|E1|Reported Event|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
221147|NCT01127256|B3|Baseline|Total|Total of all reporting groups
221148|NCT01127256|B2|Baseline|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221149|NCT01127256|B1|Baseline|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221150|NCT01127256|P2|Participant Flow|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221151|NCT01127256|P1|Participant Flow|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221152|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221153|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221154|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221155|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221156|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221157|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221158|NCT01127256|E2|Reported Event|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
221159|NCT01127256|E1|Reported Event|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
221160|NCT01127165|B3|Baseline|Total|Total of all reporting groups
221161|NCT01127165|B2|Baseline|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221162|NCT01127165|B1|Baseline|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221163|NCT01127165|P2|Participant Flow|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221164|NCT01127165|P1|Participant Flow|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221165|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221166|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221167|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221168|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221169|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221170|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221171|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221172|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221173|NCT01127165|E2|Reported Event|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
221174|NCT01127165|E1|Reported Event|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
221175|NCT01127139|B1|Baseline|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221176|NCT01127139|P1|Participant Flow|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221177|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221178|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221179|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221180|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221181|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221182|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221183|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221184|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221185|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221186|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221187|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221188|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
221189|NCT01127139|E1|Reported Event|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
221190|NCT01127087|B3|Baseline|Total|Total of all reporting groups
221191|NCT01127087|B2|Baseline|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221192|NCT01127087|B1|Baseline|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221193|NCT01127087|P2|Participant Flow|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221194|NCT01127087|P1|Participant Flow|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221195|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221196|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221197|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221198|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221199|NCT01127087|E2|Reported Event|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221200|NCT01127087|E1|Reported Event|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
221201|NCT01126801|B3|Baseline|Total|Total of all reporting groups
221202|NCT01126801|B2|Baseline|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
221203|NCT01126801|B1|Baseline|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
221204|NCT01126801|P2|Participant Flow|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
221205|NCT01126801|P1|Participant Flow|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
221206|NCT01126801|O2|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
221207|NCT01126801|O1|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
221208|NCT01126801|E2|Reported Event|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
221211|NCT01126723|B2|Baseline|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
221212|NCT01126723|B1|Baseline|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
221213|NCT01126723|P2|Participant Flow|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
221214|NCT01126723|P1|Participant Flow|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
221215|NCT01126723|O2|Outcome|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
221216|NCT01126723|O1|Outcome|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
221217|NCT01126723|E2|Reported Event|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
221218|NCT01126723|E1|Reported Event|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
221219|NCT01126671|B3|Baseline|Total|Total of all reporting groups
221220|NCT01126671|B2|Baseline|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
221221|NCT01126671|B1|Baseline|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
221222|NCT01126671|P2|Participant Flow|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
221223|NCT01126671|P1|Participant Flow|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
221224|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
221225|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
221226|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
221227|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
221228|NCT01126671|E2|Reported Event|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
221229|NCT01126671|E1|Reported Event|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
221230|NCT01126619|B1|Baseline|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221231|NCT01126619|P1|Participant Flow|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221232|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221233|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221234|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221235|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221236|NCT01126619|O2|Outcome|Week 24|Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
221237|NCT01126619|O1|Outcome|Baseline|Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
221238|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221239|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221240|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221241|NCT01126619|E1|Reported Event|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
221242|NCT01126593|B4|Baseline|Total|Total of all reporting groups
221243|NCT01126593|B3|Baseline|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
221244|NCT01126593|B2|Baseline|Control Group|The control group patients will receive no continuous infusion catheter.
221245|NCT01126593|B1|Baseline|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
221246|NCT01126593|P3|Participant Flow|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
221247|NCT01126593|P2|Participant Flow|Control Group|The control group patients will receive no continuous infusion catheter.
221454|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221248|NCT01126593|P1|Participant Flow|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
221249|NCT01126593|O3|Outcome|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
221250|NCT01126593|O2|Outcome|Control Group|The control group patients will receive no continuous infusion catheter.
221251|NCT01126593|O1|Outcome|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
221252|NCT01126593|E3|Reported Event|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
221253|NCT01126593|E2|Reported Event|Control Group|The control group patients will receive no continuous infusion catheter.
221254|NCT01126593|E1|Reported Event|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
221255|NCT01126580|B4|Baseline|Total|Total of all reporting groups
221256|NCT01126580|B3|Baseline|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221257|NCT01126580|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221258|NCT01126580|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221259|NCT01126580|P3|Participant Flow|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221260|NCT01126580|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221261|NCT01126580|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221262|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221263|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221264|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221265|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221266|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221267|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221268|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221269|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221270|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221271|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221272|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221273|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221274|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221275|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221276|NCT01126580|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221277|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221278|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221279|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221280|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221281|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221282|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221283|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221284|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
222529|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
221285|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221286|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221287|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221288|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221289|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221290|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221291|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221292|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221293|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221294|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221295|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221296|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221297|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221298|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221299|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221300|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221301|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221302|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221303|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221304|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221305|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221306|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221307|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221308|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221309|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221310|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221311|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221312|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221313|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221314|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221315|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221316|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221317|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221318|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221319|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221320|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221321|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
222530|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
221322|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221323|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221324|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221325|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221326|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221327|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221328|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221329|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221330|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221331|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221332|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221333|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221334|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221335|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221336|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221337|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221338|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221339|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221340|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221341|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221342|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221343|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221344|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221345|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221346|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221347|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221348|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221349|NCT01126580|E3|Reported Event|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
221350|NCT01126580|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221351|NCT01126580|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
221352|NCT01126541|B4|Baseline|Total|Total of all reporting groups
221353|NCT01126541|B3|Baseline|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
221354|NCT01126541|B2|Baseline|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221355|NCT01126541|B1|Baseline|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221356|NCT01126541|P3|Participant Flow|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
221357|NCT01126541|P2|Participant Flow|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221358|NCT01126541|P1|Participant Flow|Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.
221359|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221360|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221361|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221362|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221363|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221364|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221365|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221366|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221367|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221368|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221369|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221370|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221371|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221372|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221373|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221455|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221374|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221375|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221376|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221377|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221378|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221379|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221380|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221381|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221382|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221383|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221384|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221385|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221386|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221387|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221388|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221389|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221390|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221450|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221451|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221391|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221392|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221393|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221394|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221395|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221396|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221397|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221398|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221399|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221400|NCT01126541|O1|Outcome|Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221401|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221402|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221403|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221404|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221405|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221406|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221407|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221452|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221491|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221408|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221409|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
221410|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221411|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221412|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221413|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221414|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221415|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221416|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221417|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221418|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221419|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221420|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221421|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221422|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221423|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221424|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221453|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221425|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221426|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221427|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221428|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221429|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221430|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221431|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221432|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221433|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
221434|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221435|NCT01126541|E3|Reported Event|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
221436|NCT01126541|E2|Reported Event|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
221437|NCT01126541|E1|Reported Event|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
221438|NCT01126437|B4|Baseline|Total|Total of all reporting groups
221439|NCT01126437|B3|Baseline|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221440|NCT01126437|B2|Baseline|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221441|NCT01126437|B1|Baseline|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221442|NCT01126437|P3|Participant Flow|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221443|NCT01126437|P2|Participant Flow|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221444|NCT01126437|P1|Participant Flow|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221445|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221446|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221447|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221448|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221449|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221456|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221457|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221458|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221459|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221460|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221461|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221462|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221463|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221464|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221465|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221466|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221467|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221468|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221469|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
221470|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221471|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221472|NCT01126437|E3|Reported Event|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~Tiotropium 18 mcg: HandiHaler"
221473|NCT01126437|E2|Reported Event|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
221474|NCT01126437|E1|Reported Event|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
221475|NCT01126424|B7|Baseline|Total|Total of all reporting groups
221476|NCT01126424|B6|Baseline|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
221477|NCT01126424|B5|Baseline|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
221478|NCT01126424|B4|Baseline|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
221479|NCT01126424|B3|Baseline|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
221480|NCT01126424|B2|Baseline|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
221481|NCT01126424|B1|Baseline|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
221482|NCT01126424|P6|Participant Flow|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
221483|NCT01126424|P5|Participant Flow|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
221484|NCT01126424|P4|Participant Flow|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
221485|NCT01126424|P3|Participant Flow|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
221486|NCT01126424|P2|Participant Flow|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
221487|NCT01126424|P1|Participant Flow|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
221488|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221489|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221490|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221492|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221493|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221494|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221495|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221496|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221497|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221498|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221499|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221500|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221501|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221502|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221503|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
221504|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221505|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221506|NCT01126424|E3|Reported Event|Placebo|Participants received 21 days of treatment with placebo.
221507|NCT01126424|E2|Reported Event|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
221508|NCT01126424|E1|Reported Event|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
221509|NCT01126359|B1|Baseline|All Study Participants|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
221510|NCT01126359|P2|Participant Flow|Placebo-Saline Then Lidocaine|Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
221511|NCT01126359|P1|Participant Flow|Lidocaine Then Placebo-Saline|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
221512|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.
221513|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
221514|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
221515|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
221516|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
221517|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
221518|NCT01126359|E4|Reported Event|Second Intervention (Lidocaine)|
221519|NCT01126359|E3|Reported Event|Second Intervention (Placebo)|
221520|NCT01126359|E2|Reported Event|First Intervention (Placebo)|
221521|NCT01126359|E1|Reported Event|First Intervention (Lidocaine)|
221522|NCT01126268|B1|Baseline|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221523|NCT01126268|P1|Participant Flow|Retapamulin Ointment 1% Group|Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
221524|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221525|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221526|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221527|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221528|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221529|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221530|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221531|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221532|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221533|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221534|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221826|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221535|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221536|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221537|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221538|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221539|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221540|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221541|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221542|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221543|NCT01126268|E1|Reported Event|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
221544|NCT01126099|B3|Baseline|Total|Total of all reporting groups
221545|NCT01126099|B2|Baseline|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221546|NCT01126099|B1|Baseline|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221547|NCT01126099|P2|Participant Flow|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221548|NCT01126099|P1|Participant Flow|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221549|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221550|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221551|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221552|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221553|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221554|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221555|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221556|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221557|NCT01126099|E2|Reported Event|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
221558|NCT01126099|E1|Reported Event|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
221559|NCT01126060|B3|Baseline|Total|Total of all reporting groups
221560|NCT01126060|B2|Baseline|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
221561|NCT01126060|B1|Baseline|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
221562|NCT01126060|P2|Participant Flow|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
221563|NCT01126060|P1|Participant Flow|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
221564|NCT01126060|O2|Outcome|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
221565|NCT01126060|O1|Outcome|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
221566|NCT01126060|E2|Reported Event|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
221567|NCT01126060|E1|Reported Event|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
221568|NCT01125930|B3|Baseline|Total|Total of all reporting groups
221569|NCT01125930|B2|Baseline|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221763|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
226647|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
221570|NCT01125930|B1|Baseline|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221571|NCT01125930|P2|Participant Flow|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221572|NCT01125930|P1|Participant Flow|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221573|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221574|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221575|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221576|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221577|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221578|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221579|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221580|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221581|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221582|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221583|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221584|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221585|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221586|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
222531|NCT01123941|E2|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
221587|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221588|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221589|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221590|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221591|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221592|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221593|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221594|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221595|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221596|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221597|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221598|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221599|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221600|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221601|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221602|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221603|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
222532|NCT01123941|E1|Reported Event|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
221604|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221605|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221606|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221607|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221608|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221609|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221610|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221611|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221612|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221613|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221614|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221615|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221616|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221617|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221618|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221619|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221620|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
222533|NCT01123928|B3|Baseline|Total|Total of all reporting groups
221621|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221622|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221623|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221624|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221625|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221626|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221627|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221628|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221629|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221630|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221631|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221632|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221633|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221634|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221635|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221636|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221637|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
223964|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
221638|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221639|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221640|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221641|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221642|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221643|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221644|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221645|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221646|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221647|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221648|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221649|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221650|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221651|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221652|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221653|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221654|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
222574|NCT01123642|O1|Outcome|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
221655|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221656|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221657|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221658|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221659|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221660|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221661|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221662|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221663|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221664|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221665|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221666|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221667|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221668|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221669|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221670|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221671|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221764|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221672|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221673|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221674|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221675|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221676|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221677|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221678|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221679|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221680|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221681|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221682|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221683|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221684|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221685|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221686|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221687|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221688|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221765|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
221689|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221690|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221691|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221692|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221693|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221694|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221695|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221696|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221697|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221698|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221699|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221700|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221701|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221702|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221703|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221704|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221705|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
223965|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
221706|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221707|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221708|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221709|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221710|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221711|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221712|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221713|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221714|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221715|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221716|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221717|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221718|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221719|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221720|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221721|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221722|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221766|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221723|NCT01125930|E2|Reported Event|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
221724|NCT01125930|E1|Reported Event|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
221725|NCT01125917|B1|Baseline|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
221726|NCT01125917|P1|Participant Flow|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
221727|NCT01125917|O1|Outcome|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
221728|NCT01125917|E1|Reported Event|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
221729|NCT01125813|B1|Baseline|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
221730|NCT01125813|P1|Participant Flow|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
221731|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
221732|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
221733|NCT01125813|E1|Reported Event|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
221734|NCT01125800|B6|Baseline|Total|Total of all reporting groups
221735|NCT01125800|B5|Baseline|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
221736|NCT01125800|B4|Baseline|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221737|NCT01125800|B3|Baseline|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221738|NCT01125800|B2|Baseline|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221739|NCT01125800|B1|Baseline|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221740|NCT01125800|P5|Participant Flow|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
221741|NCT01125800|P4|Participant Flow|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
221742|NCT01125800|P3|Participant Flow|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221743|NCT01125800|P2|Participant Flow|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221744|NCT01125800|P1|Participant Flow|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221745|NCT01125800|O2|Outcome|Adult Participants|All adult Participants were treated with sonidegib 800 mg once daily in phase II portion of the study. Pediatric patients were also enrolled in phase II portion of the study at the recommended phase II pediatric dose - 680 mg/m^2
221746|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
221747|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
221748|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221749|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221750|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221751|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221752|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
221753|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221754|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221755|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221756|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221757|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221758|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221759|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221760|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221761|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221762|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
223966|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
221767|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221768|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221769|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221770|NCT01125800|O1|Outcome|All Participants|All participants received LDE225 233, 372, 425, 680, 800 mg/m^2 once daily through oral route until disease progression, unacceptable toxicity, or consent withdrawal.
221771|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
221772|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
221773|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
221774|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
221775|NCT01125800|E5|Reported Event|Adult Participants, LDE225 800 mg|Adult participants were treated with LDE225 800 mg capsule once daily.
221776|NCT01125800|E4|Reported Event|Pediatric Participants, LDE225 680 mg/m^2|Pediatric participants received LDE225 680 mg/m^2 once daily through oral route.
221777|NCT01125800|E3|Reported Event|Pediatric Participants, LDE225 425 mg/m^2|Pediatric participants received LDE225 425 mg/m^2 once daily through oral route.
221778|NCT01125800|E2|Reported Event|Pediatric Participants, LDE225 372 mg/m^2|Pediatric participants received LDE225 372 mg/m^2 once daily through oral route.
221779|NCT01125800|E1|Reported Event|Pediatric Participants, LDE225 233 mg/m^2|Pediatric participants received LDE225 233 mg/m^2 once daily through oral route.
221780|NCT01125774|B3|Baseline|Total|Total of all reporting groups
221781|NCT01125774|B2|Baseline|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221782|NCT01125774|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221783|NCT01125774|P4|Participant Flow|Placebo - Duplicate Participants|Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221784|NCT01125774|P3|Participant Flow|Telcagepant 140 mg - Duplicate Participants|Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221785|NCT01125774|P2|Participant Flow|Placebo - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221786|NCT01125774|P1|Participant Flow|Telcagepant 140 mg - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221787|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221788|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221789|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221790|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221791|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221792|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221793|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221794|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221795|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
223967|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
221796|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221797|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221798|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221799|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221800|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221801|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221802|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221803|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221804|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221805|NCT01125774|E2|Reported Event|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221806|NCT01125774|E1|Reported Event|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
221807|NCT01125748|B3|Baseline|Total|Total of all reporting groups
221808|NCT01125748|B2|Baseline|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
221809|NCT01125748|B1|Baseline|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
221810|NCT01125748|P2|Participant Flow|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
221811|NCT01125748|P1|Participant Flow|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
221812|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
221813|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
221814|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
221815|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
221816|NCT01125748|E2|Reported Event|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
221817|NCT01125748|E1|Reported Event|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
221818|NCT01125722|B3|Baseline|Total|Total of all reporting groups
221819|NCT01125722|B2|Baseline|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221820|NCT01125722|B1|Baseline|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221821|NCT01125722|P2|Participant Flow|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221822|NCT01125722|P1|Participant Flow|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221823|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221824|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221825|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
223968|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
221827|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221828|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221829|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221830|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221831|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221832|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221833|NCT01125722|E2|Reported Event|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
221834|NCT01125722|E1|Reported Event|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
221835|NCT01125605|B1|Baseline|Observational Group|Pasconal Nerventropfen
221836|NCT01125605|P1|Participant Flow|Observational Group|Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
221837|NCT01125605|O2|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
221838|NCT01125605|O1|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
221839|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
221840|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
221841|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
221842|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
221843|NCT01125605|O2|Outcome|>= 4 Weeks|Observational group (Pasconal Nerventropfen) without concomitant medication
221844|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with concomitant medication
221845|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
221846|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
221847|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
221848|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
221849|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
221850|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
221851|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
221852|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
221853|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
221854|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
221855|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
221856|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
221857|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
221858|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
221859|NCT01125605|O2|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
221860|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
221861|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
221862|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
221863|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
221864|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
221865|NCT01125605|E1|Reported Event|Observational Group|Pasconal Nerventropfen
221866|NCT01125566|B3|Baseline|Total|Total of all reporting groups
221867|NCT01125566|B2|Baseline|Trastuzumab + Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221868|NCT01125566|B1|Baseline|Afatinib + Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221869|NCT01125566|P3|Participant Flow|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
221870|NCT01125566|P2|Participant Flow|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221889|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221890|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
223969|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
221871|NCT01125566|P1|Participant Flow|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221872|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221873|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221874|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221875|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221876|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221877|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221878|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221879|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221880|NCT01125566|E3|Reported Event|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
221881|NCT01125566|E2|Reported Event|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
221882|NCT01125566|E1|Reported Event|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
221883|NCT01125514|B1|Baseline|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
221884|NCT01125514|P1|Participant Flow|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
221885|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221886|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221887|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221888|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221891|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221892|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221893|NCT01125514|O3|Outcome|Furosemide go mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221894|NCT01125514|O2|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221895|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221896|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221897|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221898|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221899|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221900|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221901|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221902|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221903|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221904|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221905|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221906|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221907|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221908|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221909|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221910|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221911|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221912|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221913|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221914|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221915|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221916|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221917|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221918|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221919|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221920|NCT01125514|O4|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221921|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221922|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221923|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221924|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221925|NCT01125514|O3|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221926|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221927|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221928|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221929|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221930|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221931|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221932|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221933|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221934|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221935|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221936|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221937|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221938|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221939|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221940|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221941|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221942|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221943|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221944|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221945|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221946|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221947|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221948|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
221949|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
221950|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
221951|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
221952|NCT01125514|E3|Reported Event|60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo|60 mg furosemide + 300 mg aliskiren + 150 mg placebo
221953|NCT01125514|E2|Reported Event|60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo|60 mg furosemide + 150 mg aliskiren + 300 mg placebo
221954|NCT01125514|E1|Reported Event|60 mg Furosemide + 150 mg Placebo + 300 mg Placebo|60 mg furosemide + 150 mg placebo + 300 mg placebo
221955|NCT01125189|B4|Baseline|Total|Total of all reporting groups
221956|NCT01125189|B3|Baseline|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221957|NCT01125189|B2|Baseline|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221958|NCT01125189|B1|Baseline|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221959|NCT01125189|P3|Participant Flow|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221960|NCT01125189|P2|Participant Flow|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221961|NCT01125189|P1|Participant Flow|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
222021|NCT01124916|E2|Reported Event|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
221962|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221963|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221964|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221965|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221966|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221967|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221968|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221969|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221970|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221971|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221972|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221973|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221974|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221975|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
222022|NCT01124916|E1|Reported Event|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
222023|NCT01124864|B7|Baseline|Total|Total of all reporting groups
221976|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221977|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221978|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221979|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221980|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221981|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221982|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
221983|NCT01125189|E3|Reported Event|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
221984|NCT01125189|E2|Reported Event|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
221985|NCT01125189|E1|Reported Event|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
221986|NCT01125098|B3|Baseline|Total|Total of all reporting groups
221987|NCT01125098|B2|Baseline|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
221988|NCT01125098|B1|Baseline|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
221989|NCT01125098|P2|Participant Flow|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
222024|NCT01124864|B6|Baseline|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222025|NCT01124864|B5|Baseline|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222575|NCT01123642|E1|Reported Event|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
221990|NCT01125098|P1|Participant Flow|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
221991|NCT01125098|O2|Outcome|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
221992|NCT01125098|O1|Outcome|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
221993|NCT01125098|E2|Reported Event|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
221994|NCT01125098|E1|Reported Event|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
221995|NCT01124955|B3|Baseline|Total|Total of all reporting groups
221996|NCT01124955|B2|Baseline|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
221997|NCT01124955|B1|Baseline|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
221998|NCT01124955|P2|Participant Flow|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
221999|NCT01124955|P1|Participant Flow|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222000|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222001|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222002|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222003|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222004|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222005|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222006|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222007|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222008|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222009|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222010|NCT01124955|E2|Reported Event|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
222011|NCT01124955|E1|Reported Event|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
222012|NCT01124916|B3|Baseline|Total|Total of all reporting groups
222013|NCT01124916|B2|Baseline|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
222014|NCT01124916|B1|Baseline|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
222015|NCT01124916|P2|Participant Flow|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
222016|NCT01124916|P1|Participant Flow|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
222017|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
222018|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
222019|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
222020|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
222576|NCT01123512|B3|Baseline|Total|Total of all reporting groups
222026|NCT01124864|B4|Baseline|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222027|NCT01124864|B3|Baseline|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222028|NCT01124864|B2|Baseline|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222029|NCT01124864|B1|Baseline|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222030|NCT01124864|P6|Participant Flow||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222031|NCT01124864|P5|Participant Flow|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222032|NCT01124864|P4|Participant Flow|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222033|NCT01124864|P3|Participant Flow|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222034|NCT01124864|P2|Participant Flow|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222035|NCT01124864|P1|Participant Flow|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222036|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
222037|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
222038|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
222039|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
222040|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
222041|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
222042|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222043|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222044|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222045|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222046|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222047|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222048|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222049|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222050|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222051|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222052|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222053|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222054|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222055|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222056|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222057|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222058|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222059|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222060|NCT01124864|E6|Reported Event||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222061|NCT01124864|E5|Reported Event|Modified EGFR Mutant|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions.
222062|NCT01124864|E4|Reported Event|EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222063|NCT01124864|E3|Reported Event|KRAS and EGFR Wild Type|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222064|NCT01124864|E2|Reported Event|EGFR Mutant|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
222065|NCT01124864|E1|Reported Event|KRAS Mutant|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
222066|NCT01124838|B3|Baseline|Total|Total of all reporting groups
222067|NCT01124838|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222068|NCT01124838|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222069|NCT01124838|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222070|NCT01124838|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222071|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222072|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222073|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222074|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222154|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222075|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222076|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222077|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222078|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222079|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222080|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222081|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222082|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222083|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222084|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222085|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222086|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222087|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222088|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222089|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222090|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222091|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
223970|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
222092|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222093|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222094|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222095|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222096|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222097|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222098|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222099|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222100|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222101|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222102|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222103|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222104|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222105|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222106|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222107|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222108|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222304|NCT01124292|B1|Baseline|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
222109|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222110|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222111|NCT01124838|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222112|NCT01124838|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
222113|NCT01124786|B3|Baseline|Total|Total of all reporting groups
222114|NCT01124786|B2|Baseline|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222115|NCT01124786|B1|Baseline|Gemcitabine Elaidate|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222116|NCT01124786|P2|Participant Flow|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222117|NCT01124786|P1|Participant Flow|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222118|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222119|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222120|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222121|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222122|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222123|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222124|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222125|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222126|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222127|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222128|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222129|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222130|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222131|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222132|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222133|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222134|NCT01124786|E2|Reported Event|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
222135|NCT01124786|E1|Reported Event|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
222136|NCT01124643|B1|Baseline|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222137|NCT01124643|P1|Participant Flow|Replagal® (0.2 mg/kg)|Replagal 0.2 milligram per kilogram (mg/kg) intravenously (IV), every other week (EOW).
222138|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222139|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222140|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222141|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222142|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222143|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222144|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222145|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222146|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222147|NCT01124643|E1|Reported Event|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
222148|NCT01124617|B3|Baseline|Total|Total of all reporting groups
222149|NCT01124617|B2|Baseline|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222150|NCT01124617|B1|Baseline|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222151|NCT01124617|P2|Participant Flow|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222152|NCT01124617|P1|Participant Flow|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222153|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222155|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222156|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222157|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222158|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222159|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222160|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222161|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222162|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222163|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222164|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222165|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222166|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222167|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222168|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222169|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222170|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222171|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222172|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222173|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222174|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222175|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222176|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222177|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222178|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222179|NCT01124617|E2|Reported Event|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
222180|NCT01124617|E1|Reported Event|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
222181|NCT01124604|B3|Baseline|Total|Total of all reporting groups
222182|NCT01124604|B2|Baseline|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222183|NCT01124604|B1|Baseline|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222184|NCT01124604|P2|Participant Flow|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222185|NCT01124604|P1|Participant Flow|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222186|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222187|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222188|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222189|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222190|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222191|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222381|NCT01124162|B3|Baseline|Total|Total of all reporting groups
222192|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222193|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222194|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222195|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222196|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222197|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222198|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222199|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222200|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222201|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222202|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222203|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222204|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222205|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222206|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222207|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222208|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222209|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222210|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222211|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222212|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222213|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222214|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222215|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222216|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222217|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222218|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222219|NCT01124604|E2|Reported Event|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222220|NCT01124604|E1|Reported Event|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
222221|NCT01124448|B3|Baseline|Total|Total of all reporting groups
222222|NCT01124448|B2|Baseline|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
222223|NCT01124448|B1|Baseline|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
222224|NCT01124448|P2|Participant Flow|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
222225|NCT01124448|P1|Participant Flow|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
222226|NCT01124448|O2|Outcome|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
222227|NCT01124448|O1|Outcome|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
222228|NCT01124448|E2|Reported Event|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
222229|NCT01124448|E1|Reported Event|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
222230|NCT01124422|B3|Baseline|Total|Total of all reporting groups
222231|NCT01124422|B2|Baseline|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222232|NCT01124422|B1|Baseline|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
222233|NCT01124422|P3|Participant Flow|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222234|NCT01124422|P2|Participant Flow|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
222235|NCT01124422|P1|Participant Flow|Tiotropium (TIO)|Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks
222236|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222237|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222238|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222239|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222240|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222241|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222242|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222243|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222244|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222245|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222246|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222247|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222248|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222249|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222250|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222251|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222252|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222253|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222254|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222255|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222256|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222257|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222258|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222259|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222260|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222261|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222262|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222263|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222264|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222265|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222266|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222267|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222268|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222269|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
222270|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222271|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
222272|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222273|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
222274|NCT01124422|E2|Reported Event|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
222275|NCT01124422|E1|Reported Event|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
222276|NCT01124370|B1|Baseline|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222277|NCT01124370|P1|Participant Flow|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222278|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222279|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222280|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222281|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222282|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222283|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222284|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222285|NCT01124370|E1|Reported Event|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
222286|NCT01124305|B3|Baseline|Total|Total of all reporting groups
222287|NCT01124305|B2|Baseline|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222288|NCT01124305|B1|Baseline|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222289|NCT01124305|P2|Participant Flow|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222290|NCT01124305|P1|Participant Flow|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222291|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222292|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222293|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222294|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222295|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222296|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222297|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222298|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222299|NCT01124305|E2|Reported Event|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
222300|NCT01124305|E1|Reported Event|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
222301|NCT01124292|B4|Baseline|Total|Total of all reporting groups
222302|NCT01124292|B3|Baseline|Subjects With Spinal Cord Injury|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222303|NCT01124292|B2|Baseline|Able-bodied Subject Without Tongue Piercing:|Able-bodied subjects who willing to receive a tongue piercing for this study.
222305|NCT01124292|P3|Participant Flow|Subjects With Spinal Cord Injury|persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222306|NCT01124292|P2|Participant Flow|Able-bodied Subject Without Tongue Piercing|Able-bodied subjects who willing to receive a tongue piercing for this study.
222307|NCT01124292|P1|Participant Flow|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
222308|NCT01124292|O4|Outcome|Subjects With Spinal Cord Injury (Group-C): Wheelchair Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222309|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C): Computer Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222310|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222311|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222312|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222313|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222314|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222315|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222316|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222317|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222318|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222319|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222320|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222321|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222322|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222323|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222324|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222325|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222326|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222327|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222328|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222329|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222330|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222331|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222332|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222333|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222334|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222335|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222336|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222337|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222338|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222339|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222340|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222341|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222342|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222343|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222344|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222345|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222346|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222347|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222348|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222349|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222350|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222351|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222352|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222353|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222354|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222355|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222356|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222357|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222358|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222359|NCT01124292|E3|Reported Event|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
222360|NCT01124292|E2|Reported Event|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
222361|NCT01124292|E1|Reported Event|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
222362|NCT01124175|B3|Baseline|Total|Total of all reporting groups
222363|NCT01124175|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
222364|NCT01124175|B1|Baseline|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
222365|NCT01124175|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
222366|NCT01124175|P1|Participant Flow|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
222367|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222368|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222369|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222370|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222371|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222372|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222373|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222374|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222375|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222376|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222377|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222378|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222379|NCT01124175|E2|Reported Event|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
222380|NCT01124175|E1|Reported Event|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
222382|NCT01124162|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
222383|NCT01124162|B1|Baseline|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
222384|NCT01124162|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
222385|NCT01124162|P1|Participant Flow|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
222386|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222387|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222388|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222389|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222390|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222391|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222392|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222393|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222394|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222395|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222396|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222397|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
222398|NCT01124162|E2|Reported Event|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
222399|NCT01124162|E1|Reported Event|Losartan|100 mg Losartan Tablets test product dosed in either period.
222400|NCT01124149|B1|Baseline|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
222401|NCT01124149|P1|Participant Flow|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
222402|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
222403|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
222404|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
222405|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
222406|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222407|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222408|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222409|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222410|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222411|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222412|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222413|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
222522|NCT01123941|P1|Participant Flow|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
222414|NCT01124149|E2|Reported Event|MMX Mesalamine/ Mesalazine (Maintenance Phase)|2.4 g/day given QD for 12 months in the Maintenance Phase
222415|NCT01124149|E1|Reported Event|MMX Mesalamine/ Mesalazine (Acute Phase)|4.8g/day given QD for 8 weeks in the Acute Phase
222416|NCT01124097|B5|Baseline|Total|Total of all reporting groups
222417|NCT01124097|B4|Baseline|Placebo|Placebo: Tablets will be used.
222418|NCT01124097|B3|Baseline|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222419|NCT01124097|B2|Baseline|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222420|NCT01124097|B1|Baseline|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222421|NCT01124097|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
222422|NCT01124097|P3|Participant Flow|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222423|NCT01124097|P2|Participant Flow|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222424|NCT01124097|P1|Participant Flow|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222425|NCT01124097|O4|Outcome|Placebo|Placebo: Tablets will be used.
222426|NCT01124097|O3|Outcome|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222427|NCT01124097|O2|Outcome|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222428|NCT01124097|O1|Outcome|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222429|NCT01124097|E4|Reported Event|Placebo|Placebo: Tablets will be used.
222430|NCT01124097|E3|Reported Event|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222431|NCT01124097|E2|Reported Event|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222432|NCT01124097|E1|Reported Event|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
222433|NCT01124045|B3|Baseline|Total|Total of all reporting groups
222434|NCT01124045|B2|Baseline|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222435|NCT01124045|B1|Baseline|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222436|NCT01124045|P2|Participant Flow|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222437|NCT01124045|P1|Participant Flow|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222438|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222439|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222440|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222441|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222442|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222443|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222444|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222445|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222446|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222447|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222523|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
222524|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
222448|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222449|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222450|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222451|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222452|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222453|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222454|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222455|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222456|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222457|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222458|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222459|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222460|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222461|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222462|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222463|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222464|NCT01124045|E2|Reported Event|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222465|NCT01124045|E1|Reported Event|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
222466|NCT01124006|B4|Baseline|Total|Total of all reporting groups
222467|NCT01124006|B3|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222468|NCT01124006|B2|Baseline|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222469|NCT01124006|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222525|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
222526|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
222470|NCT01124006|P3|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222471|NCT01124006|P2|Participant Flow|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222472|NCT01124006|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222473|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222474|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222475|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222476|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222477|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222478|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222479|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222480|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222481|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222482|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222483|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222484|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222485|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222486|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222487|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222488|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222489|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222490|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222491|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222492|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222527|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
222493|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222494|NCT01124006|E3|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222495|NCT01124006|E2|Reported Event|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
222496|NCT01124006|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
222497|NCT01123980|B3|Baseline|Total|Total of all reporting groups
222498|NCT01123980|B2|Baseline|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222499|NCT01123980|B1|Baseline|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222500|NCT01123980|P2|Participant Flow|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222501|NCT01123980|P1|Participant Flow|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222502|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222503|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222504|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222505|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222506|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222507|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222508|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222509|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222510|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222511|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222512|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222513|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222514|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222515|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222516|NCT01123980|E2|Reported Event|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222517|NCT01123980|E1|Reported Event|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
222518|NCT01123941|B3|Baseline|Total|Total of all reporting groups
222519|NCT01123941|B2|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
222520|NCT01123941|B1|Baseline|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
222521|NCT01123941|P2|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
226648|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
222534|NCT01123928|B2|Baseline|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222535|NCT01123928|B1|Baseline|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222536|NCT01123928|P2|Participant Flow|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222537|NCT01123928|P1|Participant Flow|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222538|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222539|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222540|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222541|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222542|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222543|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222544|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222545|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222546|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222547|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222548|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222549|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222550|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222551|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222552|NCT01123928|E2|Reported Event|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
222553|NCT01123928|E1|Reported Event|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
222554|NCT01123889|B3|Baseline|Total|Total of all reporting groups
222555|NCT01123889|B2|Baseline|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222556|NCT01123889|B1|Baseline|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222557|NCT01123889|P2|Participant Flow|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222558|NCT01123889|P1|Participant Flow|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222897|NCT01122394|E2|Reported Event|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222559|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222560|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222561|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222562|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222563|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222564|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222565|NCT01123889|E2|Reported Event|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
222566|NCT01123889|E1|Reported Event|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
222567|NCT01123850|B1|Baseline|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
222568|NCT01123850|P1|Participant Flow|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
222569|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
222570|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
222571|NCT01123850|E1|Reported Event|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
222572|NCT01123642|B1|Baseline|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
222573|NCT01123642|P1|Participant Flow|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
223971|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
222577|NCT01123512|B2|Baseline|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
222578|NCT01123512|B1|Baseline|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
222579|NCT01123512|P2|Participant Flow|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
222580|NCT01123512|P1|Participant Flow|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
222581|NCT01123512|O2|Outcome|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
222582|NCT01123512|O1|Outcome|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
222583|NCT01123512|E2|Reported Event|Balloon Kyphoplasty|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
222584|NCT01123512|E1|Reported Event|Kiva VCF Treatment System|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
222585|NCT01123395|B1|Baseline|Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
222586|NCT01123395|P2|Participant Flow|Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours.
222587|NCT01123395|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
222588|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
222589|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
222590|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
222591|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
222592|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
222593|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
222594|NCT01123395|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
222595|NCT01123395|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
222596|NCT01123356|B1|Baseline|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
222597|NCT01123356|P1|Participant Flow|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
222598|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
222622|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222681|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222599|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
222600|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
222601|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
222602|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
222603|NCT01123356|E1|Reported Event|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
222604|NCT01123148|B1|Baseline|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
222605|NCT01123148|P1|Participant Flow|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
222606|NCT01123148|O1|Outcome|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
222607|NCT01123148|E1|Reported Event|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
222608|NCT01122927|B1|Baseline|All Study Participants|Participants who entered open-label treatment phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222609|NCT01122927|P2|Participant Flow|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222610|NCT01122927|P1|Participant Flow|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continued to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
222611|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222612|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222613|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222614|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222615|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222616|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222617|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222618|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222619|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222620|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222621|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222680|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222623|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222624|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222625|NCT01122927|O5|Outcome|Tanner Score at Baseline of 5|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222626|NCT01122927|O4|Outcome|Tanner Score at Baseline of 4|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222627|NCT01122927|O3|Outcome|Tanner Score at Baseline of 3|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222628|NCT01122927|O2|Outcome|Tanner Score at Baseline of 2|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222629|NCT01122927|O1|Outcome|Tanner Score at Baseline of 1|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222630|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222631|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222632|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222633|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222634|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222635|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222636|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222637|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222638|NCT01122927|E2|Reported Event|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
222639|NCT01122927|E1|Reported Event|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continue to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
222640|NCT01122862|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline parameters evaluation.
222641|NCT01122862|P3|Participant Flow|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222642|NCT01122862|P2|Participant Flow|Chlorhexidine Mouth Rinse (0.12%)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222643|NCT01122862|P1|Participant Flow|Test Mouth Rinse|Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222644|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222645|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222646|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222647|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222648|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222649|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222650|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222651|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222652|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222653|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222654|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222655|NCT01122862|O2|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222656|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222657|NCT01122862|E3|Reported Event|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222658|NCT01122862|E2|Reported Event|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222659|NCT01122862|E1|Reported Event|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
222660|NCT01122680|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
222661|NCT01122680|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Phase I, with Tiotropium 1.25 mcg in Phase II and with a matching Placebo in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
222662|NCT01122680|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with a matching Placebo in Phase I, with Tiotropium 2.5 mcg in Phase II and with Tiotropium 5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
222663|NCT01122680|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Phase I, with Tiotropium 5 mcg in Phase II and with Tiotropium 2.5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
222664|NCT01122680|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Phase I, with a matching Placebo in Phase II and with Tiotropium 1.25 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
222665|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222666|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222667|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222668|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222669|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222670|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222671|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222672|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222673|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222674|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222675|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222676|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222677|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222678|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222679|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
226649|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
222682|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222683|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222684|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222685|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222686|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222687|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222688|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222689|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222690|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222691|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222692|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222693|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222694|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222695|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222696|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222697|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222698|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222699|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222700|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222701|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222702|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222703|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222704|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222705|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222706|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222707|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222708|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222709|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222710|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222711|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222712|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222713|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222714|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
223195|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
222715|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222716|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222717|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222718|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222719|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222720|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222721|NCT01122680|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222722|NCT01122680|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222723|NCT01122680|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222724|NCT01122680|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
222725|NCT01122576|B4|Baseline|Total|Total of all reporting groups
222726|NCT01122576|B3|Baseline|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222727|NCT01122576|B2|Baseline|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222728|NCT01122576|B1|Baseline|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222729|NCT01122576|P3|Participant Flow|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
222730|NCT01122576|P2|Participant Flow|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
222731|NCT01122576|P1|Participant Flow|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
222732|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222733|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222734|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222735|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222736|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222737|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222738|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222739|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222740|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222741|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222742|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222743|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222896|NCT01122394|O1|Outcome|Tailored Intervention (TI)|"Tailored intervention based on the transtheoretical model~TI: Tailored intervention based on the transtheoretical model"
222744|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222745|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222746|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222747|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222748|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222749|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222750|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222751|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222752|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222753|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222754|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222755|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222756|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222757|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222758|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222759|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222760|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222761|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222762|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222763|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222764|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222765|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222766|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222767|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222768|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222769|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222770|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222771|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222772|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222773|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222774|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222775|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222776|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222777|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222778|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222779|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222780|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222781|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222782|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222783|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222784|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222785|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222786|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222787|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222788|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222789|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222790|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222791|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222792|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222793|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222794|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222795|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222796|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222797|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222798|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222799|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222800|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222801|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222802|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222803|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222804|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222805|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222806|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222807|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222808|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222809|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222810|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222811|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222812|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222813|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222814|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222815|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222816|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222817|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222818|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222819|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222820|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222821|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222822|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222823|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222824|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222825|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222826|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222827|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222828|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222829|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222830|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222831|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222832|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222833|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222834|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222835|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222836|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222837|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222838|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222839|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222840|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222841|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222842|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222843|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222844|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222845|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222846|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222847|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222848|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222849|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222850|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222851|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222852|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222853|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222854|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222855|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222856|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222857|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222858|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222859|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222860|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222861|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222862|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222863|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222864|NCT01122576|E3|Reported Event|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
222865|NCT01122576|E2|Reported Event|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
222866|NCT01122576|E1|Reported Event|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
222867|NCT01122511|B3|Baseline|Total|Total of all reporting groups
222868|NCT01122511|B2|Baseline|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222869|NCT01122511|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222870|NCT01122511|P2|Participant Flow|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222871|NCT01122511|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222872|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222873|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222874|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222875|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222876|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222877|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222878|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222879|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222880|NCT01122511|E2|Reported Event|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
222881|NCT01122511|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
222882|NCT01122394|B3|Baseline|Total|Total of all reporting groups
222883|NCT01122394|B2|Baseline|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222884|NCT01122394|B1|Baseline|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222885|NCT01122394|P2|Participant Flow|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222886|NCT01122394|P1|Participant Flow|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222887|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222888|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222889|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222890|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222891|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222892|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222893|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
222894|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222895|NCT01122394|O2|Outcome|Attention Placebo (AP)|"Attention Placebo~AP: Attention placebo"
222898|NCT01122394|E1|Reported Event|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
222899|NCT01122381|B3|Baseline|Total|Total of all reporting groups
222900|NCT01122381|B2|Baseline|Arm 2|"placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
222901|NCT01122381|B1|Baseline|Arm 1|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
222902|NCT01122381|P2|Participant Flow|Arm 2-placebo|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
222903|NCT01122381|P1|Participant Flow|Arm 1-drug Treatment|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
222904|NCT01122381|O2|Outcome|Arm 2-placebo Comparator|Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
222905|NCT01122381|O1|Outcome|Arm 1-ethosuximide|Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
222906|NCT01122381|E2|Reported Event|Arm 2- Placebo Comparator|"placebo blinded capsules of 250mg; subject was titrated up to 4 capsules qd"
222907|NCT01122381|E1|Reported Event|Arm 1- Ethosuximide|ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd
222908|NCT01122264|B4|Baseline|Total|Total of all reporting groups
222909|NCT01122264|B3|Baseline|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222910|NCT01122264|B2|Baseline|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222911|NCT01122264|B1|Baseline|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222912|NCT01122264|P3|Participant Flow|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222913|NCT01122264|P2|Participant Flow|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222914|NCT01122264|P1|Participant Flow|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222915|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222916|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222917|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222918|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222919|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222920|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222921|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222922|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222923|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222924|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222925|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222926|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222927|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222928|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
223196|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
222929|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222930|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222931|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222932|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222933|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222934|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222935|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222936|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222937|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222938|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222939|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
222940|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
222941|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
222942|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222943|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222944|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222945|NCT01122264|O1|Outcome|Entire Study Population|"Tadalafil On Demand: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).~Tadalafil Once a Day: Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.~Sildenafil Citrate On Demand: Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day)."
222946|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222947|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222948|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222949|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222950|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222951|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222952|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222953|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222954|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222955|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222956|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222957|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222958|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222959|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
226650|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
222960|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222961|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222962|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222963|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222964|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222965|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222966|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222967|NCT01122264|E3|Reported Event|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222968|NCT01122264|E2|Reported Event|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
222969|NCT01122264|E1|Reported Event|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
222970|NCT01122238|B17|Baseline|Total|Total of all reporting groups
222971|NCT01122238|B16|Baseline|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222972|NCT01122238|B15|Baseline|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222973|NCT01122238|B14|Baseline|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222974|NCT01122238|B13|Baseline|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222975|NCT01122238|B12|Baseline|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222976|NCT01122238|B11|Baseline|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222977|NCT01122238|B10|Baseline|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222978|NCT01122238|B9|Baseline|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222979|NCT01122238|B8|Baseline|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222980|NCT01122238|B7|Baseline|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222981|NCT01122238|B6|Baseline|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222982|NCT01122238|B5|Baseline|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222983|NCT01122238|B4|Baseline|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222984|NCT01122238|B3|Baseline|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222985|NCT01122238|B2|Baseline|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222986|NCT01122238|B1|Baseline|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
223197|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223198|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
222987|NCT01122238|P16|Participant Flow|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222988|NCT01122238|P15|Participant Flow|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222989|NCT01122238|P14|Participant Flow|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222990|NCT01122238|P13|Participant Flow|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222991|NCT01122238|P12|Participant Flow|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222992|NCT01122238|P11|Participant Flow|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222993|NCT01122238|P10|Participant Flow|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222994|NCT01122238|P9|Participant Flow|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222995|NCT01122238|P8|Participant Flow|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222996|NCT01122238|P7|Participant Flow|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222997|NCT01122238|P6|Participant Flow|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
222998|NCT01122238|P5|Participant Flow|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
222999|NCT01122238|P4|Participant Flow|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
223000|NCT01122238|P3|Participant Flow|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
223001|NCT01122238|P2|Participant Flow|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
223002|NCT01122238|P1|Participant Flow|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
223003|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
223004|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
223005|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
223045|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223199|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223006|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
223007|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
223008|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
223009|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
223010|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
223011|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
223012|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
223013|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
223014|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
223015|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
223016|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
223184|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223185|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223017|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
223018|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
223019|NCT01122238|E4|Reported Event|No Medication|"No Medication~Participants randomized to this condition received no medication."
223020|NCT01122238|E3|Reported Event|Prequit Nicotine Gum Only|"Prequit Nicotine Gum Only.~Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
223021|NCT01122238|E2|Reported Event|Prequit Nicotine Patch Only|"Prequit Nicotine Patch Only~Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
223022|NCT01122238|E1|Reported Event|Prequit Combined Nicotine Patch + Gum|"Prequit Combined Nicotine Patch + Gum~Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
223023|NCT01122160|B1|Baseline|All Study Participants|All participants received both interventions.
223024|NCT01122160|P2|Participant Flow|Omeprazole First, Then Placebo|Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
223025|NCT01122160|P1|Participant Flow|Placebo First, Then Omeprazole|Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
223026|NCT01122160|O2|Outcome|Placebo|
223027|NCT01122160|O1|Outcome|Experimental|
223028|NCT01122160|E2|Reported Event|Placebo|
223029|NCT01122160|E1|Reported Event|Experimental|
223030|NCT01122108|B1|Baseline|Colesevelam HCl (3.75g) vs Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
223031|NCT01122108|P2|Participant Flow|Cholestyramine 12g First, Then Colesevelam HCl 3.75|Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
223032|NCT01122108|P1|Participant Flow|Colesevelam HCl 3.75g First, Then Cholestyramine 12g|Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
223033|NCT01122108|O2|Outcome|Cholestyramine (12g)|
223034|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
223035|NCT01122108|O2|Outcome|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
223036|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
223037|NCT01122108|E3|Reported Event|More Than 30 Minutes After Last Beverage|This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
223038|NCT01122108|E2|Reported Event|Colesevelam HCl (3.75 Grams)|
223039|NCT01122108|E1|Reported Event|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
223040|NCT01121991|B1|Baseline|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223041|NCT01121991|P1|Participant Flow|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223042|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223043|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223044|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223046|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223047|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223048|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223049|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223050|NCT01121991|E1|Reported Event|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
223051|NCT01121939|B1|Baseline|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
223052|NCT01121939|P1|Participant Flow|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
223053|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
223054|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
223055|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
223056|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
223057|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
223058|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
223059|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
223060|NCT01121939|O1|Outcome|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
223061|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
223062|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
223063|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
223064|NCT01121939|E1|Reported Event|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
223065|NCT01121926|B1|Baseline|Entire Study Population|"Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first.~IR = Immediate Release"
223066|NCT01121926|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
223067|NCT01121926|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
223186|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223972|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
223068|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223069|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223070|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223071|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223072|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223073|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223074|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223075|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223076|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223077|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223078|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223079|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223080|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223081|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223082|NCT01121926|E2|Reported Event|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223083|NCT01121926|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223084|NCT01121913|B1|Baseline|Entire Study Population|Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
223085|NCT01121913|P4|Participant Flow|Desyrel® First|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
223086|NCT01121913|P3|Participant Flow|Triticco® First|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
223087|NCT01121913|P2|Participant Flow|Trazodone Contramid® OAD (Prototype 2) First|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
223187|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223188|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223088|NCT01121913|P1|Participant Flow|Trazodone Contramid® OAD (Prototype 1) First|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
223089|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223090|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223091|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223092|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223093|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223094|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223095|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223096|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223097|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223098|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223099|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223100|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223101|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223102|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223103|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223104|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223105|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223106|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223107|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223108|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223109|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223110|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223111|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223112|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223113|NCT01121913|E4|Reported Event|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
223114|NCT01121913|E3|Reported Event|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
223115|NCT01121913|E2|Reported Event|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
223116|NCT01121913|E1|Reported Event|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
223117|NCT01121900|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
223118|NCT01121900|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
223119|NCT01121900|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
223120|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223121|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
226651|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
223122|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223123|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223124|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223125|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223126|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223127|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223128|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223129|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223130|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223131|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223132|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223133|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223134|NCT01121900|E2|Reported Event|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223135|NCT01121900|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
223136|NCT01121757|B3|Baseline|Total|Total of all reporting groups
223137|NCT01121757|B2|Baseline|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223138|NCT01121757|B1|Baseline|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223189|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223190|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223191|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223192|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223139|NCT01121757|P2|Participant Flow|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223140|NCT01121757|P1|Participant Flow|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223141|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223142|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223143|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223144|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223145|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223146|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223147|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223148|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223193|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223194|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223149|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223150|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223151|NCT01121757|E2|Reported Event|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223152|NCT01121757|E1|Reported Event|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
223153|NCT01121666|B3|Baseline|Total|Total of all reporting groups
223154|NCT01121666|B2|Baseline|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223155|NCT01121666|B1|Baseline|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223156|NCT01121666|P2|Participant Flow|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223157|NCT01121666|P1|Participant Flow|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223158|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223159|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223160|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223161|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223162|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223163|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223164|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223165|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223166|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223167|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223168|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223169|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223170|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223171|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223172|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223173|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223174|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223175|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223176|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223177|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223178|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223179|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223180|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223181|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223182|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223183|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
226652|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
223200|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223201|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223202|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223203|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223204|NCT01121666|E2|Reported Event|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223205|NCT01121666|E1|Reported Event|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
223206|NCT01121575|B7|Baseline|Total|Total of all reporting groups
223207|NCT01121575|B6|Baseline|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223208|NCT01121575|B5|Baseline|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223209|NCT01121575|B4|Baseline|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223210|NCT01121575|B3|Baseline|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223211|NCT01121575|B2|Baseline|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223212|NCT01121575|B1|Baseline|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223213|NCT01121575|P6|Participant Flow|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223214|NCT01121575|P5|Participant Flow|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223215|NCT01121575|P4|Participant Flow|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223216|NCT01121575|P3|Participant Flow|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223217|NCT01121575|P2|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223218|NCT01121575|P1|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg twice a day (BID) and oral dacomitinib 30 mg once daily (QD). The first cycle was for 28 days thereafter, each cycle was 21 days.
223219|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223220|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223221|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223222|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223223|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223224|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223225|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223226|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223227|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223228|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223229|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
223230|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
223231|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
223232|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223233|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
223234|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223235|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
223236|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223237|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
223238|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223239|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
223240|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223241|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule.
223242|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
223243|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223244|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223245|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223246|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223247|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223248|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223249|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223250|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223251|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223252|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223253|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223578|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223254|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223255|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223256|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223257|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223258|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223259|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223260|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223261|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223262|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223263|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223264|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223265|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223266|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223267|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223268|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223269|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223270|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223271|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223272|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223273|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223274|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223275|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223276|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223277|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223278|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223279|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223280|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223281|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223282|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223311|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223283|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223284|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223285|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223286|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223287|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223288|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223289|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223290|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223291|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223292|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223293|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223294|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223312|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223295|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223296|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223297|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223298|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223299|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223300|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223301|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223302|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223303|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223304|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223305|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223306|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223307|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223308|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223309|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223310|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223313|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223314|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223315|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223316|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223317|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223318|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223319|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223320|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223321|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223322|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223323|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223324|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223325|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223326|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223327|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223328|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223329|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223330|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223331|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223332|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223333|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223447|NCT01121406|E3|Reported Event|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
223334|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
223335|NCT01121575|E6|Reported Event|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
223336|NCT01121575|E5|Reported Event|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
223337|NCT01121575|E4|Reported Event|PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
223338|NCT01121575|E3|Reported Event|PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
223339|NCT01121575|E2|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
223340|NCT01121575|E1|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
223341|NCT01121562|B1|Baseline|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223342|NCT01121562|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223343|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223344|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223345|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223346|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223347|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223348|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223349|NCT01121562|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
223350|NCT01121549|B1|Baseline|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223351|NCT01121549|P1|Participant Flow|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223352|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223353|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223354|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223355|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223356|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223357|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223358|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223359|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223360|NCT01121549|E1|Reported Event|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
223482|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223696|NCT01120691|B4|Baseline|Total|Total of all reporting groups
223361|NCT01121536|B1|Baseline|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223362|NCT01121536|P1|Participant Flow|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223363|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223364|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223365|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223366|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223367|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223368|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223369|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223370|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223371|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223372|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223373|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223374|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223375|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223376|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223377|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223483|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223378|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223379|NCT01121536|E1|Reported Event|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
223380|NCT01121484|B3|Baseline|Total|Total of all reporting groups
223381|NCT01121484|B2|Baseline|Placebo|Matching placebo tablets once daily for 10 weeks
223382|NCT01121484|B1|Baseline|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223383|NCT01121484|P2|Participant Flow|Placebo|Matching placebo tablets once daily for 10 weeks
223384|NCT01121484|P1|Participant Flow|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223385|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223386|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223387|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223388|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223389|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223390|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223391|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223392|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223393|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223394|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223395|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
223396|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223397|NCT01121484|E2|Reported Event|Placebo|Matching placebo tablets once daily for 10 weeks
223398|NCT01121484|E1|Reported Event|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
223399|NCT01121406|B3|Baseline|Total|Total of all reporting groups
223400|NCT01121406|B2|Baseline|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223401|NCT01121406|B1|Baseline|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223402|NCT01121406|P2|Participant Flow|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223403|NCT01121406|P1|Participant Flow|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223404|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223405|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223574|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223406|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223407|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223408|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223409|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223410|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223411|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223412|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223413|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223414|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223415|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223416|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223417|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223418|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223419|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
223420|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223421|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223422|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
223575|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223423|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223424|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223425|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223426|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223427|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223428|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223429|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223430|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223431|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223432|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223433|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223434|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223435|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223436|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223437|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223438|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223439|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223440|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223441|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223442|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223443|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223444|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223445|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223446|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223448|NCT01121406|E2|Reported Event|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
223449|NCT01121406|E1|Reported Event|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
223450|NCT01121393|B3|Baseline|Total|Total of all reporting groups
223451|NCT01121393|B2|Baseline|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223452|NCT01121393|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223453|NCT01121393|P2|Participant Flow|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics.
223454|NCT01121393|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 milligram (mg) once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction.
223455|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223456|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223457|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223458|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223459|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
223460|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
223461|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
223462|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
223463|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
223464|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
223465|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.
223466|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.) orally
223467|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.
223468|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223469|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223470|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223471|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223472|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223473|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223474|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223475|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223476|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223477|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223478|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223479|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223480|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223481|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223484|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223485|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223486|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223487|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223488|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223489|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223490|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223491|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223492|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223493|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223494|NCT01121393|E2|Reported Event|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
223495|NCT01121393|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
223496|NCT01121263|B3|Baseline|Total|Total of all reporting groups
223497|NCT01121263|B2|Baseline|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
223498|NCT01121263|B1|Baseline|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
223499|NCT01121263|P2|Participant Flow|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
223500|NCT01121263|P1|Participant Flow|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
223501|NCT01121263|O2|Outcome|PCI Group (N=98)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - PCI Group
223502|NCT01121263|O1|Outcome|HCR Group (N=200)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - HCR Group
223503|NCT01121263|O2|Outcome|PCI Group (N=98)|Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
223504|NCT01121263|O1|Outcome|HCR Group (N=200)|Primary Outcome in Cohort 2: Intervention Cohort - HCR Group
223505|NCT01121263|E2|Reported Event|PCI Group (N=98)|Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
223506|NCT01121263|E1|Reported Event|HCR Group (N=200)|Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group
223507|NCT01121185|B3|Baseline|Total|Total of all reporting groups
223508|NCT01121185|B2|Baseline|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223509|NCT01121185|B1|Baseline|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223510|NCT01121185|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223511|NCT01121185|P1|Participant Flow|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223512|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223513|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223514|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223515|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223516|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223517|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223518|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223519|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223520|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223521|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223522|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223523|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223524|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223525|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223526|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223527|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223528|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223529|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223530|NCT01121185|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223576|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223577|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223531|NCT01121185|E1|Reported Event|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
223532|NCT01121172|B3|Baseline|Total|Total of all reporting groups
223533|NCT01121172|B2|Baseline|Lean|lean children and adolescents matched for age and gender to the obese group
223534|NCT01121172|B1|Baseline|Obese|obese children and adolescents according to International Obesity Task Force criteria
223535|NCT01121172|P2|Participant Flow|Lean|lean children and adolescents matched for age and gender to the obese group
223536|NCT01121172|P1|Participant Flow|Obese|obese children and adolescents according to International Obesity Task Force criteria
223537|NCT01121172|O1|Outcome|Obese Group|Obese children and adolescents according to IOTF criteria
223538|NCT01121172|O2|Outcome|Lean|lean children and adolescents matched for age and gender to the obese group
223539|NCT01121172|O1|Outcome|Obese|obese children and adolescents according to International Obesity Task Force criteria
223540|NCT01121172|E2|Reported Event|Lean|lean children and adolescents matched for age and gender to the obese group
223541|NCT01121172|E1|Reported Event|Obese|obese children and adolescents according to International Obesity Task Force criteria
223542|NCT01121146|B3|Baseline|Total|Total of all reporting groups
223543|NCT01121146|B2|Baseline|Standard Enduron Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
223544|NCT01121146|B1|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
223545|NCT01121146|P2|Participant Flow|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223546|NCT01121146|P1|Participant Flow|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223547|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223548|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and crosslinked polyethylene liner.
223549|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223550|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223551|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223552|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223553|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223554|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223555|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223556|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223557|NCT01121146|E2|Reported Event|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
223558|NCT01121146|E1|Reported Event|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
223559|NCT01120990|B1|Baseline|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
223560|NCT01120990|P1|Participant Flow|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
223561|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
223562|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
223563|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
223564|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
223565|NCT01120990|E1|Reported Event|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
223566|NCT01120899|B1|Baseline|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223567|NCT01120899|P1|Participant Flow|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223568|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223569|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223570|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223571|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223572|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223573|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223579|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223580|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223581|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223582|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223583|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223584|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223585|NCT01120899|E1|Reported Event|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
223586|NCT01120782|B1|Baseline|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
223587|NCT01120782|P1|Participant Flow|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
223588|NCT01120782|O1|Outcome|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
223589|NCT01120782|E1|Reported Event|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
223590|NCT01120717|B3|Baseline|Total|Total of all reporting groups
223591|NCT01120717|B2|Baseline|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223592|NCT01120717|B1|Baseline|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223593|NCT01120717|P2|Participant Flow|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223594|NCT01120717|P1|Participant Flow|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223595|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223596|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223597|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223598|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223599|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223600|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223601|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223602|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223603|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223604|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223605|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223606|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223607|NCT01120717|E2|Reported Event|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
223608|NCT01120717|E1|Reported Event|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
223609|NCT01120704|B33|Baseline|Total|Total of all reporting groups
223610|NCT01120704|B32|Baseline|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223611|NCT01120704|B31|Baseline|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223612|NCT01120704|B30|Baseline|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223613|NCT01120704|B29|Baseline|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223614|NCT01120704|B28|Baseline|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223615|NCT01120704|B27|Baseline|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223973|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
223616|NCT01120704|B26|Baseline|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223617|NCT01120704|B25|Baseline|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223618|NCT01120704|B24|Baseline|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223619|NCT01120704|B23|Baseline|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223620|NCT01120704|B22|Baseline|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223621|NCT01120704|B21|Baseline|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223622|NCT01120704|B20|Baseline|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223623|NCT01120704|B19|Baseline|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223624|NCT01120704|B18|Baseline|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223625|NCT01120704|B17|Baseline|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223626|NCT01120704|B16|Baseline|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223627|NCT01120704|B15|Baseline|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223628|NCT01120704|B14|Baseline|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223629|NCT01120704|B13|Baseline|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223630|NCT01120704|B12|Baseline|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223631|NCT01120704|B11|Baseline|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223632|NCT01120704|B10|Baseline|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223633|NCT01120704|B9|Baseline|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223634|NCT01120704|B8|Baseline|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223635|NCT01120704|B7|Baseline|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223636|NCT01120704|B6|Baseline|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223637|NCT01120704|B5|Baseline|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223638|NCT01120704|B4|Baseline|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223639|NCT01120704|B3|Baseline|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223640|NCT01120704|B2|Baseline|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223641|NCT01120704|B1|Baseline|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223642|NCT01120704|P32|Participant Flow|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223643|NCT01120704|P31|Participant Flow|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223644|NCT01120704|P30|Participant Flow|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223645|NCT01120704|P29|Participant Flow|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223646|NCT01120704|P28|Participant Flow|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223647|NCT01120704|P27|Participant Flow|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223648|NCT01120704|P26|Participant Flow|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223649|NCT01120704|P25|Participant Flow|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223650|NCT01120704|P24|Participant Flow|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223651|NCT01120704|P23|Participant Flow|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223652|NCT01120704|P22|Participant Flow|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223697|NCT01120691|B3|Baseline|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223653|NCT01120704|P21|Participant Flow|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223654|NCT01120704|P20|Participant Flow|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223655|NCT01120704|P19|Participant Flow|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223656|NCT01120704|P18|Participant Flow|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223657|NCT01120704|P17|Participant Flow|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223658|NCT01120704|P16|Participant Flow|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223659|NCT01120704|P15|Participant Flow|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223660|NCT01120704|P14|Participant Flow|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223661|NCT01120704|P13|Participant Flow|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223662|NCT01120704|P12|Participant Flow|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223663|NCT01120704|P11|Participant Flow|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223664|NCT01120704|P10|Participant Flow|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223665|NCT01120704|P9|Participant Flow|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223666|NCT01120704|P8|Participant Flow|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223667|NCT01120704|P7|Participant Flow|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223668|NCT01120704|P6|Participant Flow|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223669|NCT01120704|P5|Participant Flow|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223670|NCT01120704|P4|Participant Flow|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223698|NCT01120691|B2|Baseline|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
223671|NCT01120704|P3|Participant Flow|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223672|NCT01120704|P2|Participant Flow|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
223673|NCT01120704|P1|Participant Flow|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
223674|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
223675|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
223676|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
223677|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
223678|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
223679|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
223699|NCT01120691|B1|Baseline|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
223745|NCT01120626|B1|Baseline|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
223680|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
223681|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
223682|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
223683|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
223684|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
223685|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
223686|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
223687|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
223688|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
223689|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
223690|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
223691|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
223692|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
223693|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
223694|NCT01120704|E2|Reported Event|8 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.~IF participant smoked >10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.~IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
223695|NCT01120704|E1|Reported Event|26 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.~IF the participant smoked >10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.~IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication"
223700|NCT01120691|P3|Participant Flow|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223701|NCT01120691|P2|Participant Flow|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
223702|NCT01120691|P1|Participant Flow|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
223703|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223704|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223705|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223706|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223707|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223708|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223709|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223710|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223711|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223712|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223713|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223714|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223715|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223716|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223717|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223718|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks.Salbutamol/albuterol was available for rescue medication use throughout the study.
223719|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223720|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223721|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223974|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
223722|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223723|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223724|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223725|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223726|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223727|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223728|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223729|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223730|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223731|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223732|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223733|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223734|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223735|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223736|NCT01120691|O2|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223737|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223738|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223739|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223740|NCT01120691|E3|Reported Event|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device. for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223741|NCT01120691|E2|Reported Event|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223742|NCT01120691|E1|Reported Event|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
223743|NCT01120626|B3|Baseline|Total|Total of all reporting groups
223744|NCT01120626|B2|Baseline|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
223975|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
223746|NCT01120626|P2|Participant Flow|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
223747|NCT01120626|P1|Participant Flow|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
223748|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
223749|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
223750|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
223751|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
223752|NCT01120626|E2|Reported Event|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
223753|NCT01120626|E1|Reported Event|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
223754|NCT01120405|B3|Baseline|Total|Total of all reporting groups
223755|NCT01120405|B2|Baseline|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
223756|NCT01120405|B1|Baseline|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
223757|NCT01120405|P2|Participant Flow|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223758|NCT01120405|P1|Participant Flow|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223759|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223760|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223761|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223762|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223763|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
223764|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
223765|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223766|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223767|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223768|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223769|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223770|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223771|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223772|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223773|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223774|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223775|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223776|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223777|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223778|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223779|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223780|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223781|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223782|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223783|NCT01120405|E2|Reported Event|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
223784|NCT01120405|E1|Reported Event|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
223785|NCT01120379|B1|Baseline|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223786|NCT01120379|P1|Participant Flow|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223787|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223788|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223789|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223790|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223791|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223792|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223793|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223794|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223976|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
223977|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
223795|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223796|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223797|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223798|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223799|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223800|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223801|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223802|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223803|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223804|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223805|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223806|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223807|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223808|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223809|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223810|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223811|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223812|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223813|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223814|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223815|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223816|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223817|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223818|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223819|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223820|NCT01120379|E1|Reported Event|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
223821|NCT01120275|B1|Baseline|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223822|NCT01120275|P1|Participant Flow|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223823|NCT01120275|O1|Outcome|RO4929097|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223824|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223978|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
223979|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
223825|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223826|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
223827|NCT01120275|E1|Reported Event|RO4929097|Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
223828|NCT01120236|B3|Baseline|Total|Total of all reporting groups
223829|NCT01120236|B2|Baseline|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223830|NCT01120236|B1|Baseline|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223831|NCT01120236|P2|Participant Flow|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223832|NCT01120236|P1|Participant Flow|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223833|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223834|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223835|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
223836|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
223837|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223838|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
223839|NCT01120236|E2|Reported Event|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
223840|NCT01120236|E1|Reported Event|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
223841|NCT01120223|B1|Baseline|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223980|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
223842|NCT01120223|P1|Participant Flow|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223843|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223844|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223845|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223846|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223847|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223848|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223849|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223850|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223851|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223852|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223853|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223854|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223855|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223856|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223857|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223858|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223859|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223860|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223861|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223862|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223863|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223864|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223865|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223866|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223867|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223981|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
223868|NCT01120223|E1|Reported Event|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
223869|NCT01120210|B3|Baseline|Total|Total of all reporting groups
223870|NCT01120210|B2|Baseline|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223871|NCT01120210|B1|Baseline|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223872|NCT01120210|P2|Participant Flow|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223873|NCT01120210|P1|Participant Flow|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223874|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223875|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223876|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223877|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223878|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223879|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223880|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223881|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223882|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223883|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223884|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223885|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223886|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223887|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223888|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223889|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223890|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223891|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223892|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223893|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223894|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223895|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223896|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223897|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223898|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
223899|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
223900|NCT01120210|E2|Reported Event|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223901|NCT01120210|E1|Reported Event|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
223902|NCT01120197|B3|Baseline|Total|Total of all reporting groups
223903|NCT01120197|B2|Baseline|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
223904|NCT01120197|B1|Baseline|Exercise Group|: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223905|NCT01120197|P2|Participant Flow|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
223906|NCT01120197|P1|Participant Flow|Exercise Group|"Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).~The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005)."
223907|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
223908|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223909|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
223910|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223911|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
223958|NCT01120067|E1|Reported Event|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
223912|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223913|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
223914|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223915|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
223916|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223917|NCT01120197|E2|Reported Event|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
223918|NCT01120197|E1|Reported Event|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
223919|NCT01120093|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
223920|NCT01120093|P5|Participant Flow|Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
223921|NCT01120093|P4|Participant Flow|Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
223922|NCT01120093|P3|Participant Flow|Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
223959|NCT01119950|B1|Baseline|All Participants|All participants in the safety set
223960|NCT01119950|P1|Participant Flow|Overall Study|"For the overall study, 388 participants were randomized and 1 non-randomized participant received drug in error and was discontinued. This participant was excluded from randomized number of patients but included in number of treated participants and in the safety set.~Out of the 388 participants randomized, 341 completed study treatment and 47 discontinued, including 3 misrandomized participants who did not receive any study medication."
223961|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
223962|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
223963|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
223923|NCT01120093|P2|Participant Flow|Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
223924|NCT01120093|P1|Participant Flow|Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days."
223925|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
223926|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
223927|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
223928|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
223929|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
223930|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
223931|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
223932|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
223933|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
223934|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
223935|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
223936|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
223937|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
223938|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
223939|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
223940|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
223941|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
223942|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
223943|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
223944|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
223945|NCT01120093|E5|Reported Event|Placebo|Inhaled placebo dose for 7 days.
223946|NCT01120093|E4|Reported Event|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
223947|NCT01120093|E3|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
223948|NCT01120093|E2|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
223949|NCT01120093|E1|Reported Event|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
223950|NCT01120067|B3|Baseline|Total|Total of all reporting groups
223951|NCT01120067|B2|Baseline|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
223952|NCT01120067|B1|Baseline|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
223953|NCT01120067|P2|Participant Flow|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
223954|NCT01120067|P1|Participant Flow|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
223955|NCT01120067|O2|Outcome|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
223956|NCT01120067|O1|Outcome|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
223957|NCT01120067|E2|Reported Event|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
223982|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
223983|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
223984|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
223985|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
223986|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
223987|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
223988|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
223989|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
223990|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
223991|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
223992|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
223993|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
223994|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
223995|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
223996|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
223997|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
223998|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
223999|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224000|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224001|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224002|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224003|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224004|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224005|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224006|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224007|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224008|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224009|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224010|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224011|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224012|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224013|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224014|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224015|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224016|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224017|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224018|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224019|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224020|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224021|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224022|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224023|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224024|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224025|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224026|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224027|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224028|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224029|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224030|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224031|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224032|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224033|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224034|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224035|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224036|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224037|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224038|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224039|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224040|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224041|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224042|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224043|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224044|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224045|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224046|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224047|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224048|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224049|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224050|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224051|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224052|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224053|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224054|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224055|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224056|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224057|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224058|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224059|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224060|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224061|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224062|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224063|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224064|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224065|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224066|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224067|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224068|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224069|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224070|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224071|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224072|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224073|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224074|NCT01119950|O7|Outcome|NVA237 50 ug b.i.d.|NVA237 50 ug twice daily
224075|NCT01119950|O6|Outcome|NVA237 100 ug q.d.|NVA237 100 ug once daily
224076|NCT01119950|O5|Outcome|NVA237 25 ug b.i.d.|NVA237 25 ug twice daily
224077|NCT01119950|O4|Outcome|NVA237 50 ug q.d.|NVA237 50 ug once daily
224078|NCT01119950|O3|Outcome|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug twice daily
224079|NCT01119950|O2|Outcome|NVA237 25 ug q.d.|NVA237 12.5 ug once daily
224080|NCT01119950|O1|Outcome|NVA237 12.5 ug q.d.|NVA237 25 ug once daily
224081|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224082|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224083|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224084|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224085|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224086|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224087|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224088|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
224089|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224090|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224091|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224092|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224093|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224094|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224095|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224096|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224097|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224098|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224099|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224100|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224101|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224102|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224103|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224104|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224105|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224106|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224107|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224108|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224109|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224110|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224111|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224112|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224113|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224114|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224115|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224116|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224117|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224118|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224119|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224120|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224121|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224122|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224123|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224124|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224125|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224126|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224127|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224128|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224129|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224130|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224131|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224132|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224133|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224134|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224135|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224136|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224137|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224138|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224139|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224140|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224141|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224142|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224143|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224144|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224145|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224146|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224147|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224148|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224149|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224150|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224151|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224152|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224153|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224154|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224155|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224156|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224157|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224158|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224159|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224160|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224161|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224162|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224163|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224164|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224165|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224166|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224167|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224168|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224169|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224170|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224171|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224172|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224173|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224174|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224175|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224176|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224177|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224178|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224179|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224180|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224181|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224182|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224183|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224184|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224185|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224186|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224187|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
224188|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
224189|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
224190|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
224191|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
224192|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
224193|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
224194|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
224195|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
224196|NCT01119950|E8|Reported Event|Placebo|Placebo
224197|NCT01119950|E7|Reported Event|NVA237 50 ug b.i.d.|NVA237 50 ug b.i.d.
224198|NCT01119950|E6|Reported Event|NVA237 100 ug q.d.|NVA237 100 ug q.d.
224199|NCT01119950|E5|Reported Event|NVA237 25 ug b.i.d.|NVA237 25 ug b.i.d.
224200|NCT01119950|E4|Reported Event|NVA237 50 ug q.d.|NVA237 50 ug q.d.
224201|NCT01119950|E3|Reported Event|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug b.i.d.
224202|NCT01119950|E2|Reported Event|NVA237 25 ug q.d.|NVA237 25 ug q.d.
224203|NCT01119950|E1|Reported Event|NVA237 12.5 ug q.d.|NVA237 12.5 ug q.d.
224204|NCT01119937|B3|Baseline|Total|Total of all reporting groups
224205|NCT01119937|B2|Baseline|Tiotropium|18µg once daily
224206|NCT01119937|B1|Baseline|NVA237|50µg once daily
224207|NCT01119937|P2|Participant Flow|Tiotropium|18µg once daily
224208|NCT01119937|P1|Participant Flow|NVA237|50µg once daily
224209|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224210|NCT01119937|O1|Outcome|NVA237|50µg once daily
224211|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224212|NCT01119937|O1|Outcome|NVA237|50µg once daily
224213|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224214|NCT01119937|O1|Outcome|NVA237|50µg once daily
224215|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224216|NCT01119937|O1|Outcome|NVA237|50µg once daily
224217|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224218|NCT01119937|O1|Outcome|NVA237|50µg once daily
224219|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224220|NCT01119937|O1|Outcome|NVA237|50µg once daily
224221|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224222|NCT01119937|O1|Outcome|NVA237|50µg once daily
224223|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224224|NCT01119937|O1|Outcome|NVA237|50µg once daily
224225|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224226|NCT01119937|O1|Outcome|NVA237|50µg once daily
224227|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224228|NCT01119937|O1|Outcome|NVA237|50µg once daily
224229|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
224230|NCT01119937|O1|Outcome|NVA237|50µg once daily
224231|NCT01119937|E2|Reported Event|Tiotropium|18µg once daily
224232|NCT01119937|E1|Reported Event|NVA237|50µg once daily
224233|NCT01119859|B3|Baseline|Total|Total of all reporting groups
224234|NCT01119859|B2|Baseline|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224235|NCT01119859|B1|Baseline|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224236|NCT01119859|P2|Participant Flow|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224237|NCT01119859|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224238|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224239|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224240|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224241|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224242|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224243|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224244|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224245|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224246|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224247|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224248|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224249|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224250|NCT01119859|E2|Reported Event|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
224251|NCT01119859|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
224252|NCT01119794|B1|Baseline|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
224253|NCT01119794|P1|Participant Flow|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
224254|NCT01119794|O1|Outcome|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
224387|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224255|NCT01119794|E1|Reported Event|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
224256|NCT01119768|B3|Baseline|Total|Total of all reporting groups
224257|NCT01119768|B2|Baseline|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224258|NCT01119768|B1|Baseline|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224259|NCT01119768|P2|Participant Flow|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224260|NCT01119768|P1|Participant Flow|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224261|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224262|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224263|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224264|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224265|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224266|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224267|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224268|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224269|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224270|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224271|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224272|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224273|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224274|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224275|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224276|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224277|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224278|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224279|NCT01119768|E2|Reported Event|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
224280|NCT01119768|E1|Reported Event|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
224281|NCT01119755|B1|Baseline|Group 1|
224282|NCT01119755|P1|Participant Flow|Group 1|
224283|NCT01119755|O1|Outcome|Group 1|
224284|NCT01119755|O1|Outcome|Group 1|
224285|NCT01119755|O1|Outcome|Group 1|
224286|NCT01119755|O1|Outcome|Group 1|
224287|NCT01119755|O1|Outcome|Group 1|
224288|NCT01119755|O1|Outcome|Group 1|
224289|NCT01119755|O1|Outcome|Group 1|
224290|NCT01119755|O1|Outcome|Group 1|
224291|NCT01119755|E1|Reported Event|Group 1|
224292|NCT01119716|B1|Baseline|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224293|NCT01119716|P1|Participant Flow|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224294|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224295|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224296|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224297|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224298|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
224299|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
224300|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224301|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224302|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224303|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224304|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224305|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224306|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224307|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224308|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224309|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224310|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224311|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224312|NCT01119716|E1|Reported Event|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
224313|NCT01119703|B3|Baseline|Total|Total of all reporting groups
224314|NCT01119703|B2|Baseline|Elderly Participants|Aged 65 years and older
224315|NCT01119703|B1|Baseline|Younger Participants|Aged 25 to 40 years old
224316|NCT01119703|P2|Participant Flow|Elderly Participants|Participants 65 years old and older.
224317|NCT01119703|P1|Participant Flow|Younger Participants|Participants 25 to 40 years of age.
224318|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224319|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224320|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224321|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224322|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224323|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224324|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224325|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
224326|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older.
224327|NCT01119703|E1|Reported Event|All Participants|Participants who received at least one dose of each vaccine
224328|NCT01119625|B3|Baseline|Total|Total of all reporting groups
224329|NCT01119625|B2|Baseline|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224330|NCT01119625|B1|Baseline|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224331|NCT01119625|P2|Participant Flow|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224332|NCT01119625|P1|Participant Flow|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224333|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224334|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224335|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224336|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224687|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224337|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224338|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224339|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224340|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224341|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224342|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224343|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224344|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224345|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224346|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224347|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224348|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224349|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224350|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224351|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224352|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224353|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224354|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224355|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224356|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224357|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224358|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224359|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224360|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224361|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224362|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224363|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224364|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224365|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224366|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224367|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224368|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224369|NCT01119625|E2|Reported Event|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224370|NCT01119625|E1|Reported Event|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
224371|NCT01119443|B3|Baseline|Total|Total of all reporting groups
224372|NCT01119443|B2|Baseline|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
224373|NCT01119443|B1|Baseline|Treatment Sequence A|1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
224374|NCT01119443|P2|Participant Flow|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
224375|NCT01119443|P1|Participant Flow|Treatment Sequence A|1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
224376|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224377|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224378|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224379|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224380|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224381|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224382|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224383|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224384|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224385|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224386|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224688|NCT01118624|E1|Reported Event|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224388|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224389|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224390|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
224391|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
224392|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224393|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224394|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224395|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224396|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224397|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224398|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224399|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224400|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224401|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224402|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224403|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224404|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224405|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224406|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
224407|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
224408|NCT01119443|E3|Reported Event|1.5 mg q.d. Fast|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
224409|NCT01119443|E2|Reported Event|1.5 mg q.d. Fed|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)
224410|NCT01119443|E1|Reported Event|Up-titration|Up-titration to 0.75mg (10 days)
224411|NCT01119287|B7|Baseline|Total|Total of all reporting groups
224412|NCT01119287|B6|Baseline|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224413|NCT01119287|B5|Baseline|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224414|NCT01119287|B4|Baseline|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224415|NCT01119287|B3|Baseline|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224416|NCT01119287|B2|Baseline|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224417|NCT01119287|B1|Baseline|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224418|NCT01119287|P6|Participant Flow|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224419|NCT01119287|P5|Participant Flow|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224420|NCT01119287|P4|Participant Flow|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224421|NCT01119287|P3|Participant Flow|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224422|NCT01119287|P2|Participant Flow|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224423|NCT01119287|P1|Participant Flow|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224424|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224425|NCT01119287|O3|Outcome|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224426|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224427|NCT01119287|O1|Outcome|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224689|NCT01118455|B3|Baseline|Total|Total of all reporting groups
225637|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
224428|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224429|NCT01119287|O3|Outcome|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224430|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224431|NCT01119287|O1|Outcome|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224432|NCT01119287|E3|Reported Event|Tears Naturale II|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224433|NCT01119287|E2|Reported Event|Patanol|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224434|NCT01119287|E1|Reported Event|Maxidex|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
224435|NCT01119222|B1|Baseline|Entire Study Population|Includes all participants who initiated in any treatment sequence
224436|NCT01119222|P4|Participant Flow|Diphenhydramine, Placebo, Gabapentin, Morphine|Diphenhydramine 50 mg tablet first, then placebo (capsules, tablet and intravenous (IV), then gabapentin 1200 mg capsule, then morphine 10 mg IV.
224437|NCT01119222|P3|Participant Flow|Gabapentin, Diphenhydramine, Morphine, Placebo|Gabapentin 1200 mg capsule first, then diphenhydramine 50 mg tablet, then morphine 10 mg intravenous (IV), then placebo (capsules, tablet and IV).
224438|NCT01119222|P2|Participant Flow|Morphine, Gabapentin, Placebo, Diphenhydramine|Morphine 10 mg intravenous (IV) first, then gabapentin 1200 mg capsule, placebo (capsules, tablet and IV), then diphenhydramine 50 mg tablet.
224439|NCT01119222|P1|Participant Flow|Placebo, Morphine, Diphenhydramine, Gabapentin|Placebo (capsules, tablet and intravenous (IV) first, then morphine 10 mg IV, then diphenhydramine 50 mg tablet, then gabapentin 1200 mg capsule.
224440|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224441|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224442|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224443|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224444|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224445|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224446|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224447|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224448|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224449|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224450|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224451|NCT01119222|O1|Outcome|Gabapentin|Gabapentin 1200 mg
224452|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224453|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224454|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224455|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224456|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224457|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224458|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224459|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224460|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224461|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224462|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224463|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224464|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224465|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224466|NCT01119222|O2|Outcome|Morphine|Morphine 10 mg
224467|NCT01119222|O1|Outcome|Gabpentin|Gabapentin 1200 mg
224468|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
224469|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224470|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
224471|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
224472|NCT01119222|E4|Reported Event|Placebo|Oral and IV doses to match active treatments
224473|NCT01119222|E3|Reported Event|Diphenhydramine|Diphenhydramine single oral 50 mg dose
224474|NCT01119222|E2|Reported Event|Morphine|Morphine single IV 10 mg dose
224475|NCT01119222|E1|Reported Event|Gabapentin|Gabapentin single oral 1200 mg dose
224476|NCT01119131|B4|Baseline|Total|Total of all reporting groups
224477|NCT01119131|B3|Baseline|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224478|NCT01119131|B2|Baseline|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224479|NCT01119131|B1|Baseline|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224480|NCT01119131|P3|Participant Flow|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224481|NCT01119131|P2|Participant Flow|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
225004|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224482|NCT01119131|P1|Participant Flow|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224483|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224484|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224485|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224486|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224487|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224488|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224489|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224490|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224491|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224492|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224493|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224494|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224495|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224496|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224497|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224498|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224499|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224500|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224501|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224502|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224503|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224504|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224505|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224506|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224507|NCT01119131|E3|Reported Event|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
224508|NCT01119131|E2|Reported Event|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224509|NCT01119131|E1|Reported Event|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
224510|NCT01119118|B1|Baseline|ZD4054|ZD4054 + multimodal PET/MRI imaging
224511|NCT01119118|P1|Participant Flow|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224512|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224513|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224514|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224515|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224516|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
224517|NCT01119118|E1|Reported Event|ZD4054|ZD4054 + multimodal PET/MRI imaging
224518|NCT01119040|B1|Baseline|Peg Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
224519|NCT01119040|P1|Participant Flow|"NOTES PEG Rescue"|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
224520|NCT01119040|O1|Outcome|NOTES PEG Rescue|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
224521|NCT01119040|E1|Reported Event|NOTES PEG Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
224522|NCT01119001|B1|Baseline|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
224523|NCT01119001|P1|Participant Flow|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
224524|NCT01119001|O3|Outcome|Assistive Technology Enironment|Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
224525|NCT01119001|O2|Outcome|Computer Environment|Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.
224526|NCT01119001|O1|Outcome|Brain-computer Interface (BCI) Environment|Accuracy typing for three sessions with the BCI acting as a stand-alone device.
224527|NCT01119001|E1|Reported Event|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
224528|NCT01118988|B4|Baseline|Total|Total of all reporting groups
224529|NCT01118988|B3|Baseline|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
224530|NCT01118988|B2|Baseline|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224531|NCT01118988|B1|Baseline|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224532|NCT01118988|P3|Participant Flow|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
224533|NCT01118988|P2|Participant Flow|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224534|NCT01118988|P1|Participant Flow|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224535|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224536|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224537|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224538|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224539|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224590|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224776|NCT01118312|B2|Baseline|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
224540|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224541|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224542|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224543|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224544|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224545|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224546|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224547|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224548|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224549|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224550|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224551|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224552|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224553|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224554|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224555|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224556|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224557|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224619|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224558|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224559|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224560|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224561|NCT01118988|E3|Reported Event|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
224562|NCT01118988|E2|Reported Event|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
224563|NCT01118988|E1|Reported Event|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
224564|NCT01118975|B3|Baseline|Total|Total of all reporting groups
224565|NCT01118975|B2|Baseline|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
224566|NCT01118975|B1|Baseline|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
224567|NCT01118975|P2|Participant Flow|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
224568|NCT01118975|P1|Participant Flow|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
224569|NCT01118975|O1|Outcome|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days off
224570|NCT01118975|O1|Outcome|Pilot Phase|The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
224571|NCT01118975|E2|Reported Event|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
224572|NCT01118975|E1|Reported Event|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
224573|NCT01118962|B1|Baseline|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
224574|NCT01118962|P1|Participant Flow|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
224575|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
224576|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
224577|NCT01118962|E1|Reported Event|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
224578|NCT01118949|B1|Baseline|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224777|NCT01118312|B1|Baseline|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
224579|NCT01118949|P1|Participant Flow|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224580|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224581|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224582|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224583|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224584|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224585|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224586|NCT01118949|E1|Reported Event|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
224587|NCT01118845|B1|Baseline|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224588|NCT01118845|P1|Participant Flow|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224589|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224778|NCT01118312|P2|Participant Flow|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
226653|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
224591|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224592|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224593|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224594|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224595|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224596|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224597|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224598|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224599|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224600|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224601|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224602|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224603|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224604|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224605|NCT01118845|E1|Reported Event|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
224606|NCT01118780|B3|Baseline|Total|Total of all reporting groups
224607|NCT01118780|B2|Baseline|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
226654|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
224608|NCT01118780|B1|Baseline|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224609|NCT01118780|P2|Participant Flow|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224610|NCT01118780|P1|Participant Flow|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224611|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224612|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224613|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224614|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224615|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224616|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224617|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224618|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224620|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224621|NCT01118780|O3|Outcome|Placebo|Participants, whose final dose during the treatment period was either placebo or duloxetine 30 mg, were administered a placebo capsule orally, once daily for 2 weeks, during the 2-week taper period.
224622|NCT01118780|O2|Outcome|Duloxetine 60 mg Then 30 mg|Participants, whose final dose during the treatment period was 90 mg or 120 mg duloxetine, were administered duloxetine 60 mg (two 30-mg duloxetine capsules) orally, once daily for 1 week followed by a 30-mg duloxetine capsule orally, once daily for 1 week, during the 2-week taper period.
224623|NCT01118780|O1|Outcome|Duloxetine 30 mg Then Placebo|Participants, whose final dose during the treatment period was duloxetine 60 mg, were administered a 30-mg duloxetine capsule orally, once daily for 1 week followed by a placebo capsule orally, once daily for 1 week, during the 2-week taper period.
224624|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224625|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224626|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224627|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224628|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224629|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224630|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224631|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224632|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
226655|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
224633|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224634|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224635|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224636|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224637|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224638|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224639|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224640|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224641|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224642|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224643|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224644|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224645|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224646|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224647|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224648|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224649|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224650|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224651|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224652|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224653|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224654|NCT01118780|E2|Reported Event|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
224681|NCT01118663|E1|Reported Event|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224682|NCT01118624|B1|Baseline|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224683|NCT01118624|P1|Participant Flow|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
226656|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
224655|NCT01118780|E1|Reported Event|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
224656|NCT01118741|B3|Baseline|Total|Total of all reporting groups
224657|NCT01118741|B2|Baseline|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
224658|NCT01118741|B1|Baseline|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
224659|NCT01118741|P2|Participant Flow|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
224660|NCT01118741|P1|Participant Flow|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
224661|NCT01118741|O2|Outcome|Disulfiram High Dose 500mg Dose|
224662|NCT01118741|O1|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
224663|NCT01118741|E2|Reported Event|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
224664|NCT01118741|E1|Reported Event|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
224665|NCT01118663|B3|Baseline|Total|Total of all reporting groups
224666|NCT01118663|B2|Baseline|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224667|NCT01118663|B1|Baseline|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224668|NCT01118663|P2|Participant Flow|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224669|NCT01118663|P1|Participant Flow|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224670|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224671|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224672|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224673|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224674|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224675|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224676|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224677|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224678|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224679|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
224680|NCT01118663|E2|Reported Event|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
224684|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224685|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224686|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
224690|NCT01118455|B2|Baseline|Anti-Epileptic Drug (AED) - ITT Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
224691|NCT01118455|B1|Baseline|Vagus Nerve Stimulation (VNS) Therapy - ITT Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
224692|NCT01118455|P2|Participant Flow|Anti-Epileptic Drug (AED) - ITT Population|Anti-epileptic drug therapy
224693|NCT01118455|P1|Participant Flow|Vagus Nerve Stimulation (VNS) - ITT Population|Vagus Nerve Stimulation (VNS) Therapy
224694|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
224695|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
224696|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
224697|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
224698|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
224699|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
224700|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
224701|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
224702|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
224703|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
224704|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
224705|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
224706|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
224707|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
224708|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
224709|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
224710|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
224711|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
224712|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
224713|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
224714|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
224715|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
224716|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
224717|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
224718|NCT01118455|E2|Reported Event|Anti-Epileptic Drug (AED) - Safety Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment."
224719|NCT01118455|E1|Reported Event|Vagus Nerve Stimulation (VNS) Therapy - Safety Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.~NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population."
224720|NCT01118377|B1|Baseline|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
224721|NCT01118377|P1|Participant Flow|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
225638|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
224722|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
224723|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
224724|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
224725|NCT01118377|E1|Reported Event|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
224726|NCT01118325|B4|Baseline|Total|Total of all reporting groups
224727|NCT01118325|B3|Baseline|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224728|NCT01118325|B2|Baseline|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224729|NCT01118325|B1|Baseline|AZD6140 45 mg bd|AZD6140 45 mg twice daily
224730|NCT01118325|P3|Participant Flow|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224731|NCT01118325|P2|Participant Flow|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224732|NCT01118325|P1|Participant Flow|AZD6140 45 mg bd|AZD6140 45 mg twice daily
224733|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224734|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese Patients
224735|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224736|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese Patients
224737|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224738|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
224739|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224740|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
224741|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Jpanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224742|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
224743|NCT01118325|O2|Outcome|AZD6140 45mg bd in Non-Jpanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224744|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
224745|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224746|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
224747|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224748|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
224749|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224750|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
224751|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224752|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
224753|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
224754|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
224755|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
224756|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
224757|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224758|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224759|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
224760|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224761|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224762|NCT01118325|O1|Outcome|Arm 1 - AZD6140 45 mg bd|AZD6140 45 mg twice daily
224763|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224764|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224765|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
224766|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224767|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
224768|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
224769|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224770|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
224771|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
224772|NCT01118325|E3|Reported Event|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
224773|NCT01118325|E2|Reported Event|AZD6140 90 mg bd|AZD6140 90 mg twice daily
224774|NCT01118325|E1|Reported Event|AZD6140 45 mg bd|AZD6140 45 mg twice daily
224775|NCT01118312|B3|Baseline|Total|Total of all reporting groups
225639|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
224779|NCT01118312|P1|Participant Flow|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
224780|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
224781|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
224782|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
224783|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
224784|NCT01118312|E2|Reported Event|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
224785|NCT01118312|E1|Reported Event|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
224786|NCT01118273|B7|Baseline|Total|Total of all reporting groups
224787|NCT01118273|B6|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224788|NCT01118273|B5|Baseline|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224789|NCT01118273|B4|Baseline|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224790|NCT01118273|B3|Baseline|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224791|NCT01118273|B2|Baseline|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224792|NCT01118273|B1|Baseline|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224793|NCT01118273|P6|Participant Flow|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224794|NCT01118273|P5|Participant Flow|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224795|NCT01118273|P4|Participant Flow|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224796|NCT01118273|P3|Participant Flow|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224797|NCT01118273|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224798|NCT01118273|P1|Participant Flow|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224799|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224800|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224801|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224802|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224803|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224804|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224805|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224806|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224807|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224808|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224809|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224810|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224811|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224812|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224813|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224814|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224815|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224816|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224817|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224818|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224819|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224820|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224821|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224822|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224823|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224824|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224825|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224826|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224827|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224828|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224829|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224830|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224831|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224832|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224833|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224834|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224835|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224836|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224837|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224838|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224839|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224840|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224841|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224842|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224843|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224844|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224845|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224846|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224847|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224848|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224849|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
225640|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
224850|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224851|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224852|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224853|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224854|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224855|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224856|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224857|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224858|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224859|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224860|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224861|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224862|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224863|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224864|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224865|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224866|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224867|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224868|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224869|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224870|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224871|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224872|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224873|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224874|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224875|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224876|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224877|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224878|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224879|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224880|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224881|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224882|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224883|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224884|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224885|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
225641|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
224886|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224887|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224888|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224889|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224890|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224891|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224892|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224893|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224894|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224895|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224896|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224897|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224898|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224899|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224900|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224901|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224902|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224903|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224904|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224905|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224906|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224907|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224908|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224909|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224910|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224911|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224912|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224913|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224914|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224915|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224916|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224917|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224918|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224919|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224920|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224921|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
225642|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
224922|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224923|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224924|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224925|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224926|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224927|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224928|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224929|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224930|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224931|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224932|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224933|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224934|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224935|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224936|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224937|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224938|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224939|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224940|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224941|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224942|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224943|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224944|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224945|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224946|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224947|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224948|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224949|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224950|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224951|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224952|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224953|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224954|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224955|NCT01118273|E6|Reported Event|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
224956|NCT01118273|E5|Reported Event|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
224957|NCT01118273|E4|Reported Event|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
224958|NCT01118273|E3|Reported Event|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
224959|NCT01118273|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
224960|NCT01118273|E1|Reported Event|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
224961|NCT01118221|B3|Baseline|Total|Total of all reporting groups
224962|NCT01118221|B2|Baseline|Control|no structured exercise
224963|NCT01118221|B1|Baseline|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
224964|NCT01118221|P2|Participant Flow|Control|no structured exercise
224965|NCT01118221|P1|Participant Flow|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
224966|NCT01118221|O2|Outcome|Control Group|no structured exercise
224967|NCT01118221|O1|Outcome|Rehabilitation Group|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
224968|NCT01118221|O2|Outcome|After Exercise Testing|Plasma isoprostanes after exercise testing.
224969|NCT01118221|O1|Outcome|Before Exercise Testing|Plasma isoprostanes before exercise test.
224970|NCT01118221|O2|Outcome|Arm 2|no structured exercise
224971|NCT01118221|O1|Outcome|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
224972|NCT01118221|E2|Reported Event|Arm 2|no structured exercise
224973|NCT01118221|E1|Reported Event|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
224974|NCT01118143|B3|Baseline|Total|Total of all reporting groups
224975|NCT01118143|B2|Baseline|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
224976|NCT01118143|B1|Baseline|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
224977|NCT01118143|P2|Participant Flow|Control: Short Standard Information|Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
224978|NCT01118143|P1|Participant Flow|Experiment: Communication Adapted to Health Literacy Level|Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
224979|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
224980|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
224981|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
224982|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
224983|NCT01118143|E2|Reported Event|Control|The oral health instruction is according to standard clinical practice
224984|NCT01118143|E1|Reported Event|Individualized Oral Health Instruction|The oral health instruction is individualized according to the patients oral health literacy level
224985|NCT01118117|B3|Baseline|Total|Total of all reporting groups
224986|NCT01118117|B2|Baseline|Long Length (150mm) Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
224987|NCT01118117|B1|Baseline|Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224988|NCT01118117|P2|Participant Flow|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
224989|NCT01118117|P1|Participant Flow|Misago™ Self-Expanding Stent System|Subjects received treatment with the Misago™ Self-Expanding Stent
224990|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224991|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224992|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
224993|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224994|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
224995|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224996|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
224997|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224998|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
224999|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
225000|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
225001|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
225002|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
225003|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
225005|NCT01118117|E2|Reported Event|Long Length Stent Sub-study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
225006|NCT01118117|E1|Reported Event|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
225007|NCT01118091|B3|Baseline|Total|Total of all reporting groups
225008|NCT01118091|B2|Baseline|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225009|NCT01118091|B1|Baseline|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225010|NCT01118091|P2|Participant Flow|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225011|NCT01118091|P1|Participant Flow|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225012|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225013|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225014|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225015|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225016|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225017|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225018|NCT01118091|E2|Reported Event|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
225072|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225019|NCT01118091|E1|Reported Event|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
225020|NCT01117987|B3|Baseline|Total|Total of all reporting groups
225021|NCT01117987|B2|Baseline|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225022|NCT01117987|B1|Baseline|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225023|NCT01117987|P2|Participant Flow|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225024|NCT01117987|P1|Participant Flow|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225025|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225026|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225027|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225028|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225029|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225030|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225031|NCT01117987|E2|Reported Event|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225032|NCT01117987|E1|Reported Event|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
225033|NCT01117948|B3|Baseline|Total|Total of all reporting groups
225034|NCT01117948|B2|Baseline|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225035|NCT01117948|B1|Baseline|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225036|NCT01117948|P2|Participant Flow|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225037|NCT01117948|P1|Participant Flow|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225038|NCT01117948|O2|Outcome|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225039|NCT01117948|O1|Outcome|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225040|NCT01117948|E2|Reported Event|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225041|NCT01117948|E1|Reported Event|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
225042|NCT01117857|B1|Baseline|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225043|NCT01117857|P1|Participant Flow|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225044|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225073|NCT01117766|E2|Reported Event|Placebo|Participants took placebo to match the pregabalin doses BID.
225288|NCT01117337|B1|Baseline|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225643|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
225045|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225046|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225047|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225048|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225049|NCT01117857|E1|Reported Event|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
225050|NCT01117766|B1|Baseline|All Participants|Includes all participants randomized to receive pregabalin first and placebo first.
225051|NCT01117766|P2|Participant Flow|Placebo Then Pregabalin|Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225052|NCT01117766|P1|Participant Flow|Pregabalin Then Placebo|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
225053|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225054|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225055|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225056|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225057|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225058|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225059|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225060|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225061|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225062|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225063|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225064|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225065|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225066|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225067|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225068|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225069|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225070|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225071|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
225289|NCT01117337|P2|Participant Flow|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225644|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
225074|NCT01117766|E1|Reported Event|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
225075|NCT01117727|B1|Baseline|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
225076|NCT01117727|P1|Participant Flow|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
225077|NCT01117727|O2|Outcome|Pilot Testing With Scan Rate at 2 Stdev|Pilot testing with scan rate set at twice the standard deviation of the reaction time.
225078|NCT01117727|O1|Outcome|Pilot Testing, 0.65 Scan Rate|Pilot subject testing protocol with scan rate at 0.65 seconds per item.
225079|NCT01117727|E1|Reported Event|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
225080|NCT01117623|B9|Baseline|Total|Total of all reporting groups
225081|NCT01117623|B8|Baseline|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225082|NCT01117623|B7|Baseline|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225083|NCT01117623|B6|Baseline|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225084|NCT01117623|B5|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225085|NCT01117623|B4|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225086|NCT01117623|B3|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225087|NCT01117623|B2|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225088|NCT01117623|B1|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225089|NCT01117623|P8|Participant Flow|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225090|NCT01117623|P7|Participant Flow|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225091|NCT01117623|P6|Participant Flow|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225092|NCT01117623|P5|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225479|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225093|NCT01117623|P4|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225094|NCT01117623|P3|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225095|NCT01117623|P2|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225096|NCT01117623|P1|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral co-precipitate (CP) tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225097|NCT01117623|O2|Outcome|NSCLC Expansion Cohort, Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225098|NCT01117623|O1|Outcome|HCC Expansion Cohort, Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225099|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225100|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225101|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225102|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225103|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225104|NCT01117623|O2|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225105|NCT01117623|O1|Outcome|HCC Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225106|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225107|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225108|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225109|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225110|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225111|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225112|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225113|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225114|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225115|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225116|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225117|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225118|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225119|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225120|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225121|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225122|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225123|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225285|NCT01117350|E1|Reported Event|Comparative Period: Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225124|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225125|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225126|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225127|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225128|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225129|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225130|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225131|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225132|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225133|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225134|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225135|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225136|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225137|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225138|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225184|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225139|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225140|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225141|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225142|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225143|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225144|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225145|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225146|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225147|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225148|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225149|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225150|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225151|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225152|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225153|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225200|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225154|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225155|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225156|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225157|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225158|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225159|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225160|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225161|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225162|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225163|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225164|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225165|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225166|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225167|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225168|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225278|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225279|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225169|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225170|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225171|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225172|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225173|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225174|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225175|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225176|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225177|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225178|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225179|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225180|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225181|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225182|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225183|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225280|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225286|NCT01117337|B3|Baseline|Total|Total of all reporting groups
225185|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225186|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225187|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225188|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225189|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225190|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225191|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225192|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225193|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225194|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225195|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225196|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225197|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225198|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225199|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225281|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225287|NCT01117337|B2|Baseline|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225645|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
225201|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225202|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225203|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225204|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225205|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225206|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225207|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225208|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225209|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225210|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225211|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225212|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225213|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225214|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225215|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225282|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225481|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225216|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225217|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225218|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225219|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225220|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225221|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225222|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225223|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225224|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225225|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225226|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225227|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225228|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225229|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225230|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225283|NCT01117350|E3|Reported Event|Extension Period: Insulin Glargine|"Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.~Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days"
225231|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225232|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225233|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225234|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225235|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225236|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225237|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225238|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225239|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225240|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225241|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225242|NCT01117623|E5|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225243|NCT01117623|E4|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225244|NCT01117623|E3|Reported Event|Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle. This arm includes the participants from the dose escalation cohort: Regorafenib 100 mg and the three Expansion Cohorts 'HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg', 'HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg', 'NSCLC Expansion Cohort: Regorafenib 100 mg'.
225245|NCT01117623|E2|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225284|NCT01117350|E2|Reported Event|Comparative Period: Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
225246|NCT01117623|E1|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
225247|NCT01117480|B1|Baseline|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225248|NCT01117480|P1|Participant Flow|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225249|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225250|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225251|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225252|NCT01117480|E1|Reported Event|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
225253|NCT01117350|B3|Baseline|Total|Total of all reporting groups
225254|NCT01117350|B2|Baseline|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225255|NCT01117350|B1|Baseline|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225256|NCT01117350|P2|Participant Flow|Liraglutide (Comparative Period)/ Insulin Glargine (Extension)|"Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)~For patients included in the extension period: Insulin Glargine (dosing same as above)"
225257|NCT01117350|P1|Participant Flow|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225258|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225259|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225260|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225261|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225262|NCT01117350|O1|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225263|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225264|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225265|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225266|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225267|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225268|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225269|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225270|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225271|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225272|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225273|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225274|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
225275|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225276|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
225277|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
225290|NCT01117337|P1|Participant Flow|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225291|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225292|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225293|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225294|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225295|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225296|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225297|NCT01117337|E2|Reported Event|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
225298|NCT01117337|E1|Reported Event|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
225299|NCT01117311|B1|Baseline|Entire Study Population|Includes groups randomized to have the VNB off first and the VNB on first.
225300|NCT01117311|P2|Participant Flow|VNB on First, Then VNB Off|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
225301|NCT01117311|P1|Participant Flow|VNB Off First, Then VNB on|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).
225302|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
225303|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
225304|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
225305|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
225306|NCT01117311|E2|Reported Event|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
225307|NCT01117311|E1|Reported Event|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
225308|NCT01117181|B3|Baseline|Total|Total of all reporting groups
225309|NCT01117181|B2|Baseline|Placebo|matching placebo and psychosocial intervention
225310|NCT01117181|B1|Baseline|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225311|NCT01117181|P2|Participant Flow|Placebo|matching placebo and psychosocial intervention
225312|NCT01117181|P1|Participant Flow|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225313|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
225314|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225315|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
225316|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
225317|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
225318|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225319|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
225320|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225321|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
225322|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
225323|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
225324|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
225325|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
225326|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
225327|NCT01117181|E2|Reported Event|Placebo|matching placebo and psychosocial intervention
225328|NCT01117181|E1|Reported Event|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
225329|NCT01117090|B1|Baseline|Enrolled Subjects|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
225330|NCT01117090|P1|Participant Flow|Enrolled Subjects|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
225331|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of catheter complication from the physician
225332|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of normal catheter function from the physician
225333|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of catheter complication from the physician
225334|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of normal catheter function from the physician
225335|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
225627|NCT01116102|E4|Reported Event|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225336|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
225337|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
225338|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
225339|NCT01117090|E1|Reported Event|Enrolled Subjects|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
225340|NCT01117051|B3|Baseline|Total|Total of all reporting groups
225341|NCT01117051|B2|Baseline|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225342|NCT01117051|B1|Baseline|Placebo|placebo once daily before breakfast for up to 12 weeks
225343|NCT01117051|P2|Participant Flow|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225344|NCT01117051|P1|Participant Flow|Placebo|placebo once daily before breakfast for up to 12 weeks
225345|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225346|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225347|NCT01117051|O2|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225348|NCT01117051|O1|Outcome|Placebo|once daily before breakfast for up to 12 weeks
225349|NCT01117051|E2|Reported Event|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
225350|NCT01117051|E1|Reported Event|Placebo|once daily before breakfast for up to 12 weeks
225351|NCT01117012|B3|Baseline|Total|Total of all reporting groups
225352|NCT01117012|B2|Baseline|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225353|NCT01117012|B1|Baseline|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225354|NCT01117012|P2|Participant Flow|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225355|NCT01117012|P1|Participant Flow|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
225356|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225357|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225358|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225359|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225360|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225361|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225362|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225363|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225364|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225365|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225366|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225367|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
225368|NCT01117012|O1|Outcome|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
225369|NCT01117012|E1|Reported Event|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
225370|NCT01116986|B33|Baseline|Total|Total of all reporting groups
225371|NCT01116986|B32|Baseline|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225372|NCT01116986|B31|Baseline|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225373|NCT01116986|B30|Baseline|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225374|NCT01116986|B29|Baseline|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225375|NCT01116986|B28|Baseline|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225376|NCT01116986|B27|Baseline|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225377|NCT01116986|B26|Baseline|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225378|NCT01116986|B25|Baseline|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225379|NCT01116986|B24|Baseline|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225380|NCT01116986|B23|Baseline|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225381|NCT01116986|B22|Baseline|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225382|NCT01116986|B21|Baseline|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225383|NCT01116986|B20|Baseline|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
225384|NCT01116986|B19|Baseline|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
225385|NCT01116986|B18|Baseline|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225386|NCT01116986|B17|Baseline|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225387|NCT01116986|B16|Baseline|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225388|NCT01116986|B15|Baseline|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225389|NCT01116986|B14|Baseline|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225390|NCT01116986|B13|Baseline|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225391|NCT01116986|B12|Baseline|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225462|NCT01116986|E3|Reported Event|Pre-Quit Nicotine Gum|"Pre-Quit Nicotine Gum~Participants randomized to this condition received Pre-Quit Nicotine Gum.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
225628|NCT01116102|E3|Reported Event|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225392|NCT01116986|B11|Baseline|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225393|NCT01116986|B10|Baseline|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225394|NCT01116986|B9|Baseline|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225395|NCT01116986|B8|Baseline|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225396|NCT01116986|B7|Baseline|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225397|NCT01116986|B6|Baseline|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225398|NCT01116986|B5|Baseline|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225399|NCT01116986|B4|Baseline|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225400|NCT01116986|B3|Baseline|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225401|NCT01116986|B2|Baseline|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225402|NCT01116986|B1|Baseline|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225403|NCT01116986|P32|Participant Flow|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225404|NCT01116986|P31|Participant Flow|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225405|NCT01116986|P30|Participant Flow|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225406|NCT01116986|P29|Participant Flow|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225407|NCT01116986|P28|Participant Flow|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225408|NCT01116986|P27|Participant Flow|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225463|NCT01116986|E2|Reported Event|Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Patch.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
226657|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
225409|NCT01116986|P26|Participant Flow|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225410|NCT01116986|P25|Participant Flow|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225411|NCT01116986|P24|Participant Flow|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225412|NCT01116986|P23|Participant Flow|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225413|NCT01116986|P22|Participant Flow|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225414|NCT01116986|P21|Participant Flow|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225415|NCT01116986|P20|Participant Flow|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
225416|NCT01116986|P19|Participant Flow|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
225417|NCT01116986|P18|Participant Flow|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225418|NCT01116986|P17|Participant Flow|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225419|NCT01116986|P16|Participant Flow|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225420|NCT01116986|P15|Participant Flow|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225421|NCT01116986|P14|Participant Flow|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225422|NCT01116986|P13|Participant Flow|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225423|NCT01116986|P12|Participant Flow|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225424|NCT01116986|P11|Participant Flow|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225425|NCT01116986|P10|Participant Flow|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225480|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225629|NCT01116102|E2|Reported Event|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225426|NCT01116986|P9|Participant Flow|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225427|NCT01116986|P8|Participant Flow|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225428|NCT01116986|P7|Participant Flow|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225429|NCT01116986|P6|Participant Flow|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225430|NCT01116986|P5|Participant Flow|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225431|NCT01116986|P4|Participant Flow|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225432|NCT01116986|P3|Participant Flow|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225433|NCT01116986|P2|Participant Flow|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
225434|NCT01116986|P1|Participant Flow|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
225435|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
225436|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
225437|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
225464|NCT01116986|E1|Reported Event|Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.~Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
225465|NCT01116934|B3|Baseline|Total|Total of all reporting groups
225466|NCT01116934|B2|Baseline|Healthy Controls|9 healthy donors
225467|NCT01116934|B1|Baseline|PLS Patients|8 PLS patients (one female) from 6 families
225468|NCT01116934|P2|Participant Flow|Healthy Controls|9 healthy donors
225438|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
225439|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
225440|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
225441|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
225442|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
225443|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
225444|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
225469|NCT01116934|P1|Participant Flow|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
225470|NCT01116934|O2|Outcome|Healthy Controls|9 healthy donors
225471|NCT01116934|O1|Outcome|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
225472|NCT01116934|E2|Reported Event|Healthy Controls|9 healthy donors
225473|NCT01116934|E1|Reported Event|PLS Patients|8 PLS patients (one female) from 6 families
225474|NCT01116882|B3|Baseline|Total|Total of all reporting groups
225445|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
225446|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
225447|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
225448|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
225449|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
225450|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
225451|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
225475|NCT01116882|B2|Baseline|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225476|NCT01116882|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225477|NCT01116882|P2|Participant Flow|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225478|NCT01116882|P1|Participant Flow|PCI at a Hospital Without On-site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225452|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
225453|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
225454|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
225455|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
225456|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
225457|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
225458|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
225459|NCT01116986|E6|Reported Event|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
225460|NCT01116986|E5|Reported Event|Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
225461|NCT01116986|E4|Reported Event|No Pre-Quit Nicotine Patch Nor Gum|"No Pre-Quit Nicotine Patch nor Gum~Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum."
225482|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225483|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225484|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225485|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225486|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225487|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225488|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225489|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
225490|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
225491|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
225492|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
225493|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225494|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225495|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
225496|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
225497|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225498|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225499|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225500|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225501|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225502|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery.
225503|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225504|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225505|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225506|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225507|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225508|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225509|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225510|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225511|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
225512|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
225513|NCT01116882|E2|Reported Event|Surgery-On-Site (SOS)|Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
225514|NCT01116882|E1|Reported Event|Non-Surgery-On-Site (Non-SOS)|Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
225515|NCT01116687|B1|Baseline|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225516|NCT01116687|P1|Participant Flow|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225517|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225518|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225519|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225520|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225521|NCT01116687|E1|Reported Event|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
225522|NCT01116466|B1|Baseline|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225523|NCT01116466|P1|Participant Flow|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225524|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225525|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225526|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225527|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225528|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
226658|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
225529|NCT01116466|E1|Reported Event|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
225530|NCT01116427|B3|Baseline|Total|Total of all reporting groups
225531|NCT01116427|B2|Baseline|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225532|NCT01116427|B1|Baseline|Abatacept First, Then Placebo|Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225533|NCT01116427|P2|Participant Flow|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225534|NCT01116427|P1|Participant Flow|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225535|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225536|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225537|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225538|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225539|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225540|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225541|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225542|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225543|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225630|NCT01116102|E1|Reported Event|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225631|NCT01116024|B1|Baseline|Aortic Valve Replacement|3f Enable Aortic Bioprosthesis Model 6000
226659|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
225544|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225545|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225546|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225547|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225548|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225549|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225550|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225551|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225552|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225553|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225554|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225555|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225556|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225557|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225558|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225559|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225560|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225561|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225562|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
225563|NCT01116427|E6|Reported Event|Follow-up Phase: Placebo -> Abatacept|Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
225564|NCT01116427|E5|Reported Event|Follow-up Phase: Abatacept -> Placebo|Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64.
225565|NCT01116427|E4|Reported Event|Extension Phase: Placebo -> Abatacept|"After week 24, participants in the Placebo -> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
225566|NCT01116427|E3|Reported Event|Extension Phase: Abatacept -> Placebo|After week 24, participants in Abatacept -> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
225567|NCT01116427|E2|Reported Event|Core Phase: Placebo -> Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
225568|NCT01116427|E1|Reported Event|Core Phase: Abatacept -> Placebo|"Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
225569|NCT01116232|B1|Baseline|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
225570|NCT01116232|P1|Participant Flow|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
225571|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter~Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour~Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose."
225632|NCT01116024|P1|Participant Flow|ATS 3f Enable Aortic Bioprosthesis Model 6000|ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
225633|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
225634|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
225635|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
225636|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
225572|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
225573|NCT01116232|E1|Reported Event|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
225574|NCT01116102|B9|Baseline|Total|Total of all reporting groups
225575|NCT01116102|B8|Baseline|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225576|NCT01116102|B7|Baseline|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225577|NCT01116102|B6|Baseline|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225578|NCT01116102|B5|Baseline|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225579|NCT01116102|B4|Baseline|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225580|NCT01116102|B3|Baseline|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225581|NCT01116102|B2|Baseline|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225582|NCT01116102|B1|Baseline|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225583|NCT01116102|P8|Participant Flow|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225584|NCT01116102|P7|Participant Flow|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225585|NCT01116102|P6|Participant Flow|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225586|NCT01116102|P5|Participant Flow|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225587|NCT01116102|P4|Participant Flow|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225588|NCT01116102|P3|Participant Flow|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225589|NCT01116102|P2|Participant Flow|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225590|NCT01116102|P1|Participant Flow|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225591|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225592|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225593|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225594|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225595|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225596|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225597|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225598|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225599|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225600|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225601|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225602|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225603|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225604|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225605|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225606|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225607|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225608|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225609|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225610|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225611|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225612|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225613|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225614|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225615|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225616|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225617|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225618|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225619|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
225620|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
225621|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
225622|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
225623|NCT01116102|E8|Reported Event|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
225624|NCT01116102|E7|Reported Event|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
225625|NCT01116102|E6|Reported Event|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
225626|NCT01116102|E5|Reported Event|25 ga Needle, Dose Flush, Single-step Rate Scheme|
225646|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
225647|NCT01116024|O7|Outcome|5 Years|Gradient at 5 Years
225648|NCT01116024|O6|Outcome|4 Years|Gradient at 4 Years
225649|NCT01116024|O5|Outcome|3 Years|Gradient at 3 Years
225650|NCT01116024|O4|Outcome|2 Years|Gradient at 2 Years
225651|NCT01116024|O3|Outcome|11-14 Months|Gradient at 11-14 months
225652|NCT01116024|O2|Outcome|3-6 Months|Gradient at 3-6 Months
225653|NCT01116024|O1|Outcome|Discharge|Gradient at discharge
225654|NCT01116024|O7|Outcome|NYHA Class 5 Year|NYHA classification after 5 years.
225655|NCT01116024|O6|Outcome|NYHA Class 4 Year|NYHA classification after 4 years.
225656|NCT01116024|O5|Outcome|NYHA Class 3 Year|NYHA classification after 3 years.
225657|NCT01116024|O4|Outcome|NYHA Class 2 Year|NYHA classification after 2 years.
225658|NCT01116024|O3|Outcome|NYHA Class 11-14 Months|NYHA classification after 11-14 months.
225659|NCT01116024|O2|Outcome|NYHA Class 3-6 Months|NYHA classification after 3-6 months.
225660|NCT01116024|O1|Outcome|NYHA Class Preoperative|Preoperative numbers of NYHA classification.
225661|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225662|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225663|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225664|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225665|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225666|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225667|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225668|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
225669|NCT01116024|E1|Reported Event|Enable I Model 6000 Valve|Adverse events relating to the study safety endpoints.
225670|NCT01115998|B3|Baseline|Total|Total of all reporting groups
225671|NCT01115998|B2|Baseline|Control Group|Children received usual early intervention services, but no power wheelchair.
225672|NCT01115998|B1|Baseline|Power Wheelchair|
225673|NCT01115998|P2|Participant Flow|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
225674|NCT01115998|P1|Participant Flow|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
225675|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
225676|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
225677|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
225678|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
225679|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
225718|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225719|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225720|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225721|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
226660|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
225680|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
225681|NCT01115998|E2|Reported Event|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
225682|NCT01115998|E1|Reported Event|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
225683|NCT01115933|B1|Baseline|XIENCE PRIME SV EECSS|"XIENCE PRIME SV Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
225684|NCT01115933|P1|Participant Flow|XIENCE PRIME SV EECSS|"XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS"
225685|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225686|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225687|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|"XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
225688|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225689|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225690|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225691|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225692|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225693|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS- ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225694|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225695|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225696|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225697|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225698|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225699|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225700|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225701|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225702|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225703|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225704|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225705|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
225706|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225707|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225708|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225709|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225710|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225711|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225712|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225713|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225714|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225715|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225716|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225717|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225722|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225723|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225724|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225725|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225726|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225727|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225728|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225729|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225730|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225731|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225732|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225733|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225734|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225735|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225736|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225737|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225738|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225739|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225740|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225741|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225742|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225743|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225744|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225745|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225746|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS- TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225747|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225748|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225749|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
225750|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225751|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225752|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
225753|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225754|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225755|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
225756|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Vascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225757|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Cardiac Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225758|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - All Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225759|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
225760|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Vascular|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
225761|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - Cardiac|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225762|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS ABR Distal|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
225763|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS ABR Proximal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225764|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS ABR In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225765|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS ABR In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225766|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS LL Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225767|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS LL Proximal|XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS
225768|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS LL In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225769|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS LL In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225770|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS %DS Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225771|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS %DS Proximal|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225772|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS %DS In-stent|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
225773|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS %DS In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225774|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
225775|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225776|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
225777|NCT01115933|E1|Reported Event|AVJ-09-385 SV EECSS|"SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS"
225778|NCT01115855|B3|Baseline|Total|Total of all reporting groups
225779|NCT01115855|B2|Baseline|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225780|NCT01115855|B1|Baseline|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225781|NCT01115855|P2|Participant Flow|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225782|NCT01115855|P1|Participant Flow|Eplerenone|Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225783|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225784|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225785|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225786|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225787|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225788|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225789|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225790|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225791|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225792|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225850|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225793|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225794|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225795|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225796|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225797|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225798|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225799|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225800|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225801|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225802|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225803|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225804|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225805|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225806|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225807|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225808|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225809|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225878|NCT01115673|P2|Participant Flow|ACE-650|650 mg Acetaminophen Caplet
225879|NCT01115673|P1|Participant Flow|ACE-1000|1000 mg Acetaminophen Caplet
225810|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225811|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225812|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225813|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225814|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225815|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225816|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225817|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225818|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225819|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225820|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225821|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225822|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225823|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225824|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225825|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225826|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225880|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
225827|NCT01115855|E2|Reported Event|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
225828|NCT01115855|E1|Reported Event|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
225829|NCT01115738|B4|Baseline|Total|Total of all reporting groups
225830|NCT01115738|B3|Baseline|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225831|NCT01115738|B2|Baseline|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225832|NCT01115738|B1|Baseline|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225833|NCT01115738|P3|Participant Flow|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225834|NCT01115738|P2|Participant Flow|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225835|NCT01115738|P1|Participant Flow|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225836|NCT01115738|O6|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225837|NCT01115738|O5|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225838|NCT01115738|O4|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225839|NCT01115738|O3|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225840|NCT01115738|O2|Outcome|Placebo and 60 mg Prasugrel -CYP2C19 RM|CYP2C19 reduced metabolizers treated with placebo LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225841|NCT01115738|O1|Outcome|Placebo and 60 mg Prasugrel-CYP2C19 EM|CYP2C19 extensive metabolizers treated with placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225842|NCT01115738|O2|Outcome|Clopidogrel at Baseline - CYP2C19 RM|600-mg clopidogrel LD administered once orally before PCI.
225843|NCT01115738|O1|Outcome|Clopidogrel at Baseline -CYP2C19 EM|600-milligram (mg) clopidogrel loading dose (LD) administered once orally before percutaneous coronary intervention (PCI).
225844|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225845|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225846|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225847|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225848|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225849|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225851|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225852|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225853|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225854|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225855|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225856|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225857|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225858|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225859|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225860|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225861|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225862|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225863|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225864|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225865|NCT01115738|E3|Reported Event|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225866|NCT01115738|E2|Reported Event|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225867|NCT01115738|E1|Reported Event|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
225868|NCT01115699|B1|Baseline|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
225869|NCT01115699|P1|Participant Flow|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
225870|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
225871|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
225872|NCT01115699|E1|Reported Event|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
225873|NCT01115673|B4|Baseline|Total|Total of all reporting groups
225874|NCT01115673|B3|Baseline|ACE-0|0 mg Acetaminophen Caplet
225875|NCT01115673|B2|Baseline|ACE-650|650 mg Acetaminophen Caplet
225876|NCT01115673|B1|Baseline|ACE-1000|1000 mg Acetaminophen Caplet
225877|NCT01115673|P3|Participant Flow|ACE-0|0 mg Acetaminophen Caplet
226013|NCT01115660|B2|Baseline|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
226014|NCT01115660|B1|Baseline|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
226015|NCT01115660|P2|Participant Flow|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
226016|NCT01115660|P1|Participant Flow|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
226017|NCT01115660|O2|Outcome|Control|standard of care
226018|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
226019|NCT01115660|O2|Outcome|Control|standard of care
226020|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
226021|NCT01115660|E2|Reported Event|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
226022|NCT01115660|E1|Reported Event|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
226023|NCT01115582|B1|Baseline|Cholic Acid|All patients entered and treated
226024|NCT01115582|P1|Participant Flow|Cholic Acid|All patients entered and treated
226025|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226026|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226027|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226028|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226029|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226030|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
226031|NCT01115582|E1|Reported Event|Cholic Acid|All patients entered and treated
226032|NCT01115569|B1|Baseline|Open-label Hydrocodone Bitartate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
226033|NCT01115569|P2|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
226034|NCT01115569|P1|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
226035|NCT01115569|O1|Outcome|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
226036|NCT01115569|E2|Reported Event|Maintenance Treatment Phase|"Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
226037|NCT01115569|E1|Reported Event|Conversion/Titration Phase|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks
226038|NCT01115517|B3|Baseline|Total|Total of all reporting groups
226039|NCT01115517|B2|Baseline|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226040|NCT01115517|B1|Baseline|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226041|NCT01115517|P2|Participant Flow|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226042|NCT01115517|P1|Participant Flow|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226043|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226044|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226045|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226046|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226047|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226048|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226115|NCT01115166|E1|Reported Event|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226049|NCT01115517|E2|Reported Event|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
226050|NCT01115517|E1|Reported Event|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
226051|NCT01115491|B1|Baseline|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226052|NCT01115491|P1|Participant Flow|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226053|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226054|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226055|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226056|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226057|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226058|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226059|NCT01115491|E1|Reported Event|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
226060|NCT01115452|B1|Baseline|Overall Study|
226061|NCT01115452|P1|Participant Flow|5% or 2.5% Potassium Nitrate Solution or Water|Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226062|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226063|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226064|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226116|NCT01115101|B3|Baseline|Total|Total of all reporting groups
226152|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226065|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226066|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226067|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226068|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226069|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226070|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226071|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226072|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226073|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226074|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226075|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226076|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226077|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226078|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226079|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226080|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226081|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226082|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226083|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226084|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment..
226085|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226086|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226087|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226151|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226661|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/CGC genetic make-up
226088|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226089|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226090|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226091|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226092|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226093|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226094|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226095|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226096|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226097|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226098|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226099|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226100|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226101|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226102|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226103|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226104|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226105|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226106|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226107|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment
226108|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
226109|NCT01115452|E1|Reported Event|Overall Study|
226110|NCT01115166|B1|Baseline|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226111|NCT01115166|P1|Participant Flow|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226112|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226113|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226114|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
226117|NCT01115101|B2|Baseline|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
226118|NCT01115101|B1|Baseline|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
226119|NCT01115101|P2|Participant Flow|Patient Controlled Device With Pritramid|Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
226120|NCT01115101|P1|Participant Flow|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).
226121|NCT01115101|O2|Outcome|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
226122|NCT01115101|O1|Outcome|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
226123|NCT01115101|E2|Reported Event|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
226124|NCT01115101|E1|Reported Event|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
226125|NCT01114997|B4|Baseline|Total|Total of all reporting groups
226126|NCT01114997|B3|Baseline|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-Induction (Maintenance Infusion):~Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226127|NCT01114997|B2|Baseline|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226128|NCT01114997|B1|Baseline|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226129|NCT01114997|P3|Participant Flow|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226130|NCT01114997|P2|Participant Flow|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226131|NCT01114997|P1|Participant Flow|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226132|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226133|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226134|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226135|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine (12.5-25 mcg/kg/min) + Esmolol (7.5-15 mcg/kg/min)"
226136|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226137|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226138|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226139|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226140|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226141|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226142|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226143|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226144|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226145|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226146|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226147|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226148|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
226149|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226150|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226662|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
226153|NCT01114997|E3|Reported Event|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
226154|NCT01114997|E2|Reported Event|Esmolol|Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
226155|NCT01114997|E1|Reported Event|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
226156|NCT01114945|B5|Baseline|Total|Total of all reporting groups
226157|NCT01114945|B4|Baseline|McGrath|MacGrath device
226158|NCT01114945|B3|Baseline|GlideScope|GlideScope device
226159|NCT01114945|B2|Baseline|Video-Mac|Video-Mac device
226160|NCT01114945|B1|Baseline|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
226161|NCT01114945|P4|Participant Flow|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
226162|NCT01114945|P3|Participant Flow|McGrath|MacGrath
226163|NCT01114945|P2|Participant Flow|GlideScope|GlideScope device
226164|NCT01114945|P1|Participant Flow|Video-Mac|Video-Mac device
226165|NCT01114945|O4|Outcome|McGrath|MacGrath device
226166|NCT01114945|O3|Outcome|GlideScope|GlideScope device
226167|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
226168|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
226169|NCT01114945|O4|Outcome|McGrath|MacGrath device
226170|NCT01114945|O3|Outcome|GlideScope|GlideScope device
226171|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
226172|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
226173|NCT01114945|O4|Outcome|McGrath|MacGrath device
226174|NCT01114945|O3|Outcome|GlideScope|GlideScope device
226175|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
226176|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
226177|NCT01114945|O4|Outcome|McGrath|MacGrath device
226178|NCT01114945|O3|Outcome|GlideScope|GlideScope device
226179|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
226180|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
226181|NCT01114945|E4|Reported Event|Direct Macintosh Laryngoscopy|"Direct Macintosh Laryngoscopy (DL) used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
226182|NCT01114945|E3|Reported Event|McGrath|"McGrath device used during intubation procedure~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
226183|NCT01114945|E2|Reported Event|GlideScope|"GlideScope device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
226184|NCT01114945|E1|Reported Event|Video-Mac|"Video-Mac device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath"
226185|NCT01114893|B6|Baseline|Total|Total of all reporting groups
226186|NCT01114893|B5|Baseline|Travoprost Group C|Travoprost Group C
226187|NCT01114893|B4|Baseline|Travoprost Group B|Travoprost Group B
226188|NCT01114893|B3|Baseline|Travoprost Group A|Travoprost Group A
226189|NCT01114893|B2|Baseline|Travoprost Vehicle|Travoprost Vehicle
226190|NCT01114893|B1|Baseline|TRAVATAN|TRAVATAN 0.004% once daily
226191|NCT01114893|P5|Participant Flow|Travoprost Group C|Travoprost Group C
226192|NCT01114893|P4|Participant Flow|Travoprost Group B|Travoprost Group B
226193|NCT01114893|P3|Participant Flow|Travoprost Group A|Travoprost Group A
226194|NCT01114893|P2|Participant Flow|Travoprost Vehicle|Travoprost Vehicle
226195|NCT01114893|P1|Participant Flow|TRAVATAN|TRAVATAN 0.004% once daily
226196|NCT01114893|O5|Outcome|Travoprost Group C|
226197|NCT01114893|O4|Outcome|Travoprost Group B|
226198|NCT01114893|O3|Outcome|Travoprost Group A|
226199|NCT01114893|O2|Outcome|Travoprost Vehicle|
226200|NCT01114893|O1|Outcome|Travatan 0.004% QD|
226201|NCT01114893|O5|Outcome|Travoprost Group C|
226202|NCT01114893|O4|Outcome|Travoprost Group B|
226203|NCT01114893|O3|Outcome|Travoprost Group A|
226204|NCT01114893|O2|Outcome|Travoprost Vehicle|
226205|NCT01114893|O1|Outcome|Travatan 0.004% QD|
226206|NCT01114893|E5|Reported Event|Travoprost Group C|Travoprost Group C
226207|NCT01114893|E4|Reported Event|Travoprost Group B|Travoprost Group B
226208|NCT01114893|E3|Reported Event|Travoprost Group A|Travoprost Group A
226209|NCT01114893|E2|Reported Event|Travoprost Vehicle|Travoprost Vehicle
226210|NCT01114893|E1|Reported Event|TRAVATAN|TRAVATAN 0.004% once daily
226211|NCT01114880|B3|Baseline|Total|Total of all reporting groups
226212|NCT01114880|B2|Baseline|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
226213|NCT01114880|B1|Baseline|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
226214|NCT01114880|P2|Participant Flow|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
226215|NCT01114880|P1|Participant Flow|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
226216|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226663|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
226217|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226218|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226219|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226220|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226221|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226222|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226223|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226224|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226225|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226226|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226227|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226228|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226229|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226230|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226231|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226232|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226233|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226234|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226235|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226236|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226237|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226238|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226239|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226240|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226241|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226242|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226243|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226244|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226245|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226246|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226247|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226248|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226249|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226250|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226251|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226252|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226253|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226254|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226255|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226256|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226257|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226258|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226259|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
226260|NCT01114880|E4|Reported Event|Placebo/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
226261|NCT01114880|E3|Reported Event|Adalimumab/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
226262|NCT01114880|E2|Reported Event|Placebo (Period 1)|Blinded placebo from Week 0 to Week 10
226263|NCT01114880|E1|Reported Event|Adalimumab (Period 1)|Blinded adalimumab from Week 0 to Week 10
226264|NCT01114828|B3|Baseline|Total|Total of all reporting groups
226265|NCT01114828|B2|Baseline|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
226266|NCT01114828|B1|Baseline|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
226267|NCT01114828|P2|Participant Flow|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
226268|NCT01114828|P1|Participant Flow|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
226269|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
226270|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
226271|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
226272|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
226273|NCT01114828|E2|Reported Event|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
226274|NCT01114828|E1|Reported Event|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
226275|NCT01114737|B3|Baseline|Total|Total of all reporting groups
226276|NCT01114737|B2|Baseline|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
226277|NCT01114737|B1|Baseline|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
226278|NCT01114737|P2|Participant Flow|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
226279|NCT01114737|P1|Participant Flow|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
226280|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226281|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226282|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226283|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226284|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226285|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226286|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226287|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226288|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226289|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226290|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226291|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226292|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
226293|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
226294|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226295|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226296|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226297|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226298|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226299|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226300|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226301|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226302|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226303|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226304|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
226305|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
226306|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226307|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
226308|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226309|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226310|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226311|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226312|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226313|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226314|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226315|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
226316|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
226317|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
226318|NCT01114737|E8|Reported Event|6R-BH4 Treatment Period - Combined|6R-BH4 Combined Treatments - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
226319|NCT01114737|E7|Reported Event|6R-BH4 Treatment Period - 6R-BH4|6R-BH4 Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
226320|NCT01114737|E6|Reported Event|Open-Label Treatment Period - Overall|Open-label Treatment Period - All patients
226321|NCT01114737|E5|Reported Event|Open-Label Treatment Period - 6R-BH4|Open-label Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
226322|NCT01114737|E4|Reported Event|Open-Label Treatment Period - Placebo-6R-BH4|Open-label Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
226323|NCT01114737|E3|Reported Event|Randomized Treatment Period - Overall|Randomized Treatment Period - All patients
226324|NCT01114737|E2|Reported Event|Randomized Treatment Period - 6R-BH4|Randomized Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
226325|NCT01114737|E1|Reported Event|Randomized Treatment Period - Placebo|Randomized Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
226326|NCT01114724|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226327|NCT01114724|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226328|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226329|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226330|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226331|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226376|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226332|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226333|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226334|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226335|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226336|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226337|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226338|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
226339|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226340|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226341|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226342|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
226343|NCT01114724|E1|Reported Event|1. Dissection|Medtronic Dissection
226344|NCT01114672|B3|Baseline|Total|Total of all reporting groups
226345|NCT01114672|B2|Baseline|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
226346|NCT01114672|B1|Baseline|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
226347|NCT01114672|P2|Participant Flow|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
226348|NCT01114672|P1|Participant Flow|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
226349|NCT01114672|O2|Outcome|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
226350|NCT01114672|O1|Outcome|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
226351|NCT01114672|E2|Reported Event|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
226352|NCT01114672|E1|Reported Event|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
226353|NCT01114581|B3|Baseline|Total|Total of all reporting groups
226354|NCT01114581|B2|Baseline|Placebo|Given as 2 tablets
226355|NCT01114581|B1|Baseline|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
226356|NCT01114581|P2|Participant Flow|Placebo|Given as 2 tablets
226357|NCT01114581|P1|Participant Flow|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
226358|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
226359|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
226360|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
226361|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
226362|NCT01114581|E2|Reported Event|Placebo|Given as 2 tablets
226363|NCT01114581|E1|Reported Event|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
226364|NCT01114516|B3|Baseline|Total|Total of all reporting groups
226365|NCT01114516|B2|Baseline|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226366|NCT01114516|B1|Baseline|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226367|NCT01114516|P2|Participant Flow|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226368|NCT01114516|P1|Participant Flow|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226369|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226370|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226371|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226372|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226373|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226374|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226375|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226664|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
226377|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226378|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226379|NCT01114516|E2|Reported Event|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
226380|NCT01114516|E1|Reported Event|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
226381|NCT01114373|B1|Baseline|All Subjects|African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.
226382|NCT01114373|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.
226383|NCT01114373|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
226384|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
226385|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226386|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226387|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226388|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226389|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226390|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226391|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226392|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks(either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226393|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226394|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226395|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226396|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226397|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226398|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226399|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226400|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226401|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226402|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226403|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226456|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226404|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
226405|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226406|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
226407|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226408|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226409|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226410|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
226411|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226412|NCT01114373|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
226413|NCT01114373|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226414|NCT01114360|B1|Baseline|All Participants|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
226415|NCT01114360|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.
226416|NCT01114360|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
226417|NCT01114360|O2|Outcome|Placebo|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
226418|NCT01114360|O1|Outcome|Melatonin|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
226419|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between
226420|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
226421|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.
226422|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.
226423|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).
226424|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.
226425|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).
226426|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226427|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226665|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
226428|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226429|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226430|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226431|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226432|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
226433|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226434|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226435|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226436|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226437|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226438|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).
226439|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).
226440|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).
226441|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226442|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226443|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226444|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226445|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226446|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226447|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226448|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226449|NCT01114360|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
226450|NCT01114360|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
226451|NCT01113931|B3|Baseline|Total|Total of all reporting groups
226452|NCT01113931|B2|Baseline|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226453|NCT01113931|B1|Baseline|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226454|NCT01113931|P2|Participant Flow|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226455|NCT01113931|P1|Participant Flow|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226666|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
226457|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226458|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226459|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226460|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226461|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226462|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226463|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226464|NCT01113931|E2|Reported Event|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
226465|NCT01113931|E1|Reported Event|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
226466|NCT01113749|B3|Baseline|Total|Total of all reporting groups
226467|NCT01113749|B2|Baseline|Control|
226468|NCT01113749|B1|Baseline|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
226469|NCT01113749|P2|Participant Flow|Control|
226470|NCT01113749|P1|Participant Flow|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
226471|NCT01113749|O2|Outcome|Control|Usual care
226472|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
226473|NCT01113749|O2|Outcome|Control|Usual care
226474|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
226475|NCT01113749|O2|Outcome|Control|Usual care
226476|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
226477|NCT01113749|E2|Reported Event|Control|
226478|NCT01113749|E1|Reported Event|Decisions Support Intervention|
226479|NCT01113723|B3|Baseline|Total|Total of all reporting groups
226480|NCT01113723|B2|Baseline|Fiberoptic Bronchoscope|"Fiberoptic bronchoscope~Fiberoptic bronchoscope: Fiberoptic bronchoscope device"
226481|NCT01113723|B1|Baseline|CMAC Device|"CMAC~CMAC: CMAC Device"
226482|NCT01113723|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
226483|NCT01113723|P1|Participant Flow|CMAC Device|"CMAC~CMAC: CMAC Device"
226484|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
226485|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
226486|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
226487|NCT01113723|O1|Outcome|CMAC Device|"CMAC~CMAC: CMAC Device"
226488|NCT01113723|O2|Outcome|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
226489|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
226490|NCT01113723|E2|Reported Event|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
226491|NCT01113723|E1|Reported Event|CMAC Device|"CMAC~CMAC: CMAC Device"
226492|NCT01113710|B1|Baseline|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226493|NCT01113710|P1|Participant Flow|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226494|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226495|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226496|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226497|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226498|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226499|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226500|NCT01113710|E1|Reported Event|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
226501|NCT01113632|B3|Baseline|Total|Total of all reporting groups
226502|NCT01113632|B2|Baseline|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226503|NCT01113632|B1|Baseline|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226557|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226558|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226504|NCT01113632|P2|Participant Flow|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226505|NCT01113632|P1|Participant Flow|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226506|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226507|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
226508|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226509|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
226510|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226511|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
226512|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226513|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
226514|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226515|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
226559|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226516|NCT01113632|E2|Reported Event|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226517|NCT01113632|E1|Reported Event|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
226518|NCT01113580|B3|Baseline|Total|Total of all reporting groups
226519|NCT01113580|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
226520|NCT01113580|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
226521|NCT01113580|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
226522|NCT01113580|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
226523|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
226524|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
226525|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
226526|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
226527|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
226528|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
226529|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
226530|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
226531|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
226532|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
226533|NCT01113580|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
226534|NCT01113580|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
226535|NCT01113541|B1|Baseline|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226536|NCT01113541|P1|Participant Flow|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226537|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226538|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226539|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226540|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226541|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226542|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226543|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226544|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226545|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226546|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226547|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226548|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226549|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226550|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226551|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226552|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226553|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226554|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226555|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226556|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226560|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226561|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226562|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226563|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226564|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226565|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226566|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226567|NCT01113541|E1|Reported Event|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
226568|NCT01113463|B1|Baseline|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
226569|NCT01113463|P1|Participant Flow|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
226570|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
226571|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
226572|NCT01113463|E1|Reported Event|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
226573|NCT01113398|B1|Baseline|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226574|NCT01113398|P1|Participant Flow|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226575|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226576|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226577|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226578|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226579|NCT01113398|E1|Reported Event|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
226580|NCT01113385|B1|Baseline|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
226638|NCT01112670|P1|Participant Flow|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed.
226639|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
226581|NCT01113385|P1|Participant Flow|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
226582|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
226583|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
226584|NCT01113385|E1|Reported Event|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
226585|NCT01113008|B3|Baseline|Total|Total of all reporting groups
226586|NCT01113008|B2|Baseline|Control Group|Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226587|NCT01113008|B1|Baseline|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226588|NCT01113008|P2|Participant Flow|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226589|NCT01113008|P1|Participant Flow|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226590|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226591|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226592|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226593|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226594|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226595|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226596|NCT01113008|E2|Reported Event|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
226597|NCT01113008|E1|Reported Event|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
226598|NCT01112917|B1|Baseline|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
226599|NCT01112917|P2|Participant Flow|VenaTech Convertible Filter - Permanent Filtration|VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
226600|NCT01112917|P1|Participant Flow|VenaTech Convertible Filter - Converted Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
226601|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
226602|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
226603|NCT01112917|E1|Reported Event|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
226604|NCT01112865|B1|Baseline|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226640|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
226641|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
226605|NCT01112865|P2|Participant Flow|Genotropin® Pen Then Mark VII Pen|Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226606|NCT01112865|P1|Participant Flow|Mark VII Pen Then Genotropin® Pen|Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
226607|NCT01112865|O2|Outcome|Genotropin® Pen|Participants who used the current Genotropin® pen (subcutaneous injections daily for 2 months) anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226608|NCT01112865|O1|Outcome|Mark VII Pen|Participants who used the Mark VII pen (subcutaneous injections daily for 2 months) any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
226609|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226610|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226611|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226612|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226613|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
226614|NCT01112865|E1|Reported Event|Safety Population|All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.
226615|NCT01112696|B1|Baseline|Group 1|Sensor Users (All Subjects)
226616|NCT01112696|P1|Participant Flow|Group 1|Sensor Users (All Subjects)
226617|NCT01112696|O1|Outcome|All Completed Subjects|All subjects that completed the frequent blood sampling procedure
226618|NCT01112696|E1|Reported Event|Group 1|Sensor Users (All Subjects)
226619|NCT01112683|B3|Baseline|Total|Total of all reporting groups
226620|NCT01112683|B2|Baseline|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226621|NCT01112683|B1|Baseline|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226622|NCT01112683|P2|Participant Flow|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226623|NCT01112683|P1|Participant Flow|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226624|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226625|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226626|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226627|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226628|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226629|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226630|NCT01112683|E2|Reported Event|Placebo|These are identically-looking pills to the ones in the Memantine Arm
226631|NCT01112683|E1|Reported Event|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
226632|NCT01112670|B1|Baseline|Overall Study Population|All participants who participated in at least one period of the study (n=33)
226633|NCT01112670|P6|Participant Flow|ABCB1 Group 3*|ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed.
226634|NCT01112670|P5|Participant Flow|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed.
226635|NCT01112670|P4|Participant Flow|ABCB1 Group 2*|ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed.
226636|NCT01112670|P3|Participant Flow|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed.
226637|NCT01112670|P2|Participant Flow|ABCB1 Group 1*|ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed.
226642|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
226667|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
226668|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
226669|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
226670|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
226671|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
226672|NCT01112670|E1|Reported Event|Overall Study Population|All participants who started the study (n=33)
226673|NCT01112579|B3|Baseline|Total|Total of all reporting groups
226674|NCT01112579|B2|Baseline|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226675|NCT01112579|B1|Baseline|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226676|NCT01112579|P2|Participant Flow|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226677|NCT01112579|P1|Participant Flow|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226678|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226679|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226680|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226681|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226682|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226683|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226684|NCT01112579|E2|Reported Event|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
226685|NCT01112579|E1|Reported Event|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
226686|NCT01112514|B1|Baseline|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
226687|NCT01112514|P1|Participant Flow|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
226688|NCT01112514|O1|Outcome|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
226689|NCT01112514|E1|Reported Event|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
226690|NCT01112267|B3|Baseline|Total|Total of all reporting groups
226691|NCT01112267|B2|Baseline|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226692|NCT01112267|B1|Baseline|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226693|NCT01112267|P2|Participant Flow|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226694|NCT01112267|P1|Participant Flow|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226695|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226696|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226697|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226698|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226699|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226700|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226701|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226702|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226703|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226704|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226705|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226706|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226707|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226708|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226709|NCT01112267|E2|Reported Event|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226710|NCT01112267|E1|Reported Event|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
226711|NCT01112241|B1|Baseline|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226712|NCT01112241|P1|Participant Flow|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226713|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226714|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226715|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226716|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226717|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226718|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226719|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226720|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226721|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226722|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226759|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226723|NCT01112241|E1|Reported Event|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
226724|NCT01111851|B3|Baseline|Total|Total of all reporting groups
226725|NCT01111851|B2|Baseline|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226726|NCT01111851|B1|Baseline|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226727|NCT01111851|P2|Participant Flow|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226728|NCT01111851|P1|Participant Flow|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226729|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226730|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226731|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226732|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226733|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226734|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226735|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226736|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226737|NCT01111851|E2|Reported Event|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
226738|NCT01111851|E1|Reported Event|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
226739|NCT01111838|B1|Baseline|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
226740|NCT01111838|P1|Participant Flow|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
226741|NCT01111838|O1|Outcome|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
226742|NCT01111838|E1|Reported Event|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
226743|NCT01111526|B1|Baseline|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226744|NCT01111526|P3|Participant Flow|Phase II Participants Treated at MTD|All participants enrolled during Phase II.
226745|NCT01111526|P2|Participant Flow|Phase I Participants Evaluable for MTD|Participants treated after the formulation change.
226746|NCT01111526|P1|Participant Flow|Phase I Participants Not Evaluable for MTD|Participants who began treatment before the formulation change.
226747|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226748|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226749|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226750|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226751|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226752|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226753|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226754|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226755|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226756|NCT01111526|E1|Reported Event|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
226757|NCT01111461|B1|Baseline|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226758|NCT01111461|P1|Participant Flow|Lenvatinib 24 mg|Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.
226760|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226761|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226762|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226763|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226764|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226765|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226766|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226767|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226768|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226769|NCT01111461|E1|Reported Event|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
226770|NCT01111331|B1|Baseline|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, cross-over, open-label trial consisting of three treatments. 18 patients were randomised to one of two possible treatment sequences. The three treatments were~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1"
226771|NCT01111331|P2|Participant Flow|Warfarin / Empa / Empa Plus Warfarin|"Patients received three treatments in the following order~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~There was a washout period of at least 14 days between the first and second treatment periods."
226772|NCT01111331|P1|Participant Flow|Empa / Empa Plus Warfarin / Warfarin|"Patients received three treatments in the following order~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~There was a washout period of at least 14 days between the second and third treatment periods."
226773|NCT01111331|O3|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226774|NCT01111331|O2|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226775|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226776|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226777|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226778|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226779|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226780|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226781|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226782|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226783|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226784|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226785|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226786|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226787|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226788|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226789|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226790|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226791|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226792|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226793|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226794|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226795|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226796|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226797|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226798|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226799|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226800|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226801|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226802|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226803|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226804|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226805|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226806|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226807|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226808|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226809|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226810|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226811|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226812|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226813|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226814|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226815|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226816|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226817|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226818|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226819|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226820|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226821|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226822|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226823|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226824|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226825|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226826|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226827|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226828|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226829|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226830|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226831|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226832|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226833|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226834|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226835|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226836|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226837|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226838|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226839|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
228989|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
226840|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226841|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226842|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226843|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226844|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226845|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226846|NCT01111331|E3|Reported Event|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
226847|NCT01111331|E2|Reported Event|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
226848|NCT01111331|E1|Reported Event|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
226849|NCT01111318|B5|Baseline|Total|Total of all reporting groups
226850|NCT01111318|B4|Baseline|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226851|NCT01111318|B3|Baseline|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226852|NCT01111318|B2|Baseline|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226853|NCT01111318|B1|Baseline|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226854|NCT01111318|P4|Participant Flow|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226855|NCT01111318|P3|Participant Flow|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226856|NCT01111318|P2|Participant Flow|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226857|NCT01111318|P1|Participant Flow|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226858|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226859|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226860|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226861|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226862|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226863|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226864|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226865|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226866|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226867|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226868|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226869|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226870|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226871|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226872|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226873|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226874|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226875|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226876|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226877|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226878|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226879|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226880|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226881|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226882|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226883|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226884|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226885|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226886|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226887|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226888|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226889|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226890|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226891|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226892|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226893|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226894|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226895|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226896|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226897|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226898|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226899|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226900|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226901|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226902|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226903|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226904|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226905|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226906|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
228990|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
226907|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226908|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226909|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226910|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226911|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226912|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226913|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226914|NCT01111318|E4|Reported Event|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
226915|NCT01111318|E3|Reported Event|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
226916|NCT01111318|E2|Reported Event|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
226917|NCT01111318|E1|Reported Event|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
226918|NCT01111292|B3|Baseline|Total|Total of all reporting groups
226919|NCT01111292|B2|Baseline|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226920|NCT01111292|B1|Baseline|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226921|NCT01111292|P2|Participant Flow|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226922|NCT01111292|P1|Participant Flow|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226923|NCT01111292|O2|Outcome|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226924|NCT01111292|O1|Outcome|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226925|NCT01111292|E2|Reported Event|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226926|NCT01111292|E1|Reported Event|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
226927|NCT01111240|B1|Baseline|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226928|NCT01111240|P1|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226929|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226930|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226931|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226932|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226933|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226934|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226935|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226936|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226937|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226938|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226939|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
227452|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
226940|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226941|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226942|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226943|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226944|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226945|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226946|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226947|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226948|NCT01111240|E1|Reported Event|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
226949|NCT01111162|B1|Baseline|Vaccination Group (Single Arm Study)|All participants
226950|NCT01111162|P1|Participant Flow|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
226951|NCT01111162|O1|Outcome|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
226952|NCT01111162|O1|Outcome|Vacinees|
226953|NCT01111162|E1|Reported Event|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
226954|NCT01111149|B4|Baseline|Total|Total of all reporting groups
226955|NCT01111149|B3|Baseline|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226956|NCT01111149|B2|Baseline|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226957|NCT01111149|B1|Baseline|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226958|NCT01111149|P3|Participant Flow|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226959|NCT01111149|P2|Participant Flow|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226960|NCT01111149|P1|Participant Flow|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226961|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226962|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226963|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226964|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226999|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226965|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226966|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226967|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226968|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226969|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226970|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226971|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226972|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226973|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226974|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226975|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226976|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226977|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226978|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226979|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226980|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226981|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227351|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
226982|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226983|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226984|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226985|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226986|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226987|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226988|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226989|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226990|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226991|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226992|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226993|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226994|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226995|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
226996|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
226997|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
226998|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227000|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227001|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227002|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227003|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227004|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227005|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227006|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227007|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227008|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227009|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227010|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227011|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227012|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227013|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227014|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227015|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227016|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227017|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227018|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227019|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227020|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227021|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227022|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227023|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227024|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227025|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227026|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227027|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227028|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227029|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227030|NCT01111149|E3|Reported Event|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
227031|NCT01111149|E2|Reported Event|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
227032|NCT01111149|E1|Reported Event|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
227033|NCT01111123|B3|Baseline|Total|Total of all reporting groups
227034|NCT01111123|B2|Baseline|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
227035|NCT01111123|B1|Baseline|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
227036|NCT01111123|P2|Participant Flow|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
227037|NCT01111123|P1|Participant Flow|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
227038|NCT01111123|O2|Outcome|Lac-hydrin + Placebo|lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
227039|NCT01111123|O1|Outcome|Lac-hydrin + Ultravate|ammonium lactate twice daily everyday + ultravate twice daily weekends only
227040|NCT01111123|O2|Outcome|Ammoium Lactate + Placebo|ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
227041|NCT01111123|O1|Outcome|Ammonium Lactate + Ultravate|ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
227042|NCT01111123|E2|Reported Event|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
227043|NCT01111123|E1|Reported Event|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
227044|NCT01111110|B3|Baseline|Total|Total of all reporting groups
227045|NCT01111110|B2|Baseline|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
227046|NCT01111110|B1|Baseline|Anti-static/Static|albuterol with anti-static chamber then Static on another night
227047|NCT01111110|P2|Participant Flow|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
227048|NCT01111110|P1|Participant Flow|Anti-static/Static|albuterol with anti-static chamber then Static on another night
227049|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
227050|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
227051|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
227052|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
227053|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
227054|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
227055|NCT01111110|E2|Reported Event|Antistatic|albuterol with antistatic chamber.
227056|NCT01111110|E1|Reported Event|Static|albuterol with static chamber
227057|NCT01110967|B1|Baseline|Patients Implanted With a Satellite Device|
227058|NCT01110967|P1|Participant Flow|Patients Implanted With a Satellite Device|
227059|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227060|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227061|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227062|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227063|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227064|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227065|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227066|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
227067|NCT01110967|E1|Reported Event|Patients Implanted With a Satellite Device|
227068|NCT01110915|B3|Baseline|Total|Total of all reporting groups
227069|NCT01110915|B2|Baseline|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227070|NCT01110915|B1|Baseline|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227071|NCT01110915|P2|Participant Flow|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227072|NCT01110915|P1|Participant Flow|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227073|NCT01110915|O1|Outcome|Implanted Subjects|Any subject who underwent a successful implant of the Advisa MRI system.
227074|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227075|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227076|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227077|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227078|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227079|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227080|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227081|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227082|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227083|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227084|NCT01110915|E2|Reported Event|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
227085|NCT01110915|E1|Reported Event|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
227086|NCT01110499|B9|Baseline|Total|Total of all reporting groups
227087|NCT01110499|B8|Baseline|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
227088|NCT01110499|B7|Baseline|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
227089|NCT01110499|B6|Baseline|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227090|NCT01110499|B5|Baseline|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227091|NCT01110499|B4|Baseline|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227092|NCT01110499|B3|Baseline|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227093|NCT01110499|B2|Baseline|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227094|NCT01110499|B1|Baseline|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227095|NCT01110499|P8|Participant Flow|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
227096|NCT01110499|P7|Participant Flow|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
227097|NCT01110499|P6|Participant Flow|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227098|NCT01110499|P5|Participant Flow|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227099|NCT01110499|P4|Participant Flow|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227100|NCT01110499|P3|Participant Flow|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227101|NCT01110499|P2|Participant Flow|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227102|NCT01110499|P1|Participant Flow|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227103|NCT01110499|O2|Outcome|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
227104|NCT01110499|O1|Outcome|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
227105|NCT01110499|O7|Outcome|Part 1, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
227106|NCT01110499|O6|Outcome|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
227107|NCT01110499|O5|Outcome|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
227108|NCT01110499|O4|Outcome|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
227109|NCT01110499|O3|Outcome|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
227110|NCT01110499|O2|Outcome|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
227111|NCT01110499|O1|Outcome|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
227112|NCT01110499|E9|Reported Event|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
227113|NCT01110499|E8|Reported Event|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
227114|NCT01110499|E7|Reported Event|Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye|bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
227115|NCT01110499|E6|Reported Event|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227116|NCT01110499|E5|Reported Event|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227117|NCT01110499|E4|Reported Event|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227118|NCT01110499|E3|Reported Event|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227119|NCT01110499|E2|Reported Event|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227120|NCT01110499|E1|Reported Event|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
227121|NCT01110421|B3|Baseline|Total|Total of all reporting groups
227122|NCT01110421|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227123|NCT01110421|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227124|NCT01110421|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227125|NCT01110421|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227126|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227127|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227128|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227129|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227130|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227131|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227132|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227133|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227134|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227135|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227136|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227137|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227138|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227139|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227140|NCT01110421|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227141|NCT01110421|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227142|NCT01110408|B3|Baseline|Total|Total of all reporting groups
227143|NCT01110408|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227144|NCT01110408|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227145|NCT01110408|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227146|NCT01110408|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227147|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227148|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227149|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227150|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227151|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227152|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227153|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227154|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227155|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227156|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227157|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227158|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227159|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227160|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227161|NCT01110408|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227162|NCT01110408|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
227163|NCT01110382|B3|Baseline|Total|Total of all reporting groups
227164|NCT01110382|B2|Baseline|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227165|NCT01110382|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227166|NCT01110382|P2|Participant Flow|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227167|NCT01110382|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227168|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227169|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227170|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227171|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227172|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227173|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227174|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227175|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227352|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227453|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227176|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227177|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227178|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227179|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227180|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227181|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227182|NCT01110382|E2|Reported Event|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227183|NCT01110382|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
227184|NCT01110330|B4|Baseline|Total|Total of all reporting groups
227185|NCT01110330|B3|Baseline|Ketoconazole|Ketoconazole 2% cream (formulation F126)
227186|NCT01110330|B2|Baseline|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
227187|NCT01110330|B1|Baseline|Placebo|A topical white homogenous cream identical in appearance to study drug
227188|NCT01110330|P3|Participant Flow|Ketoconazole|Ketoconazole 2% cream (formulation F126)
227189|NCT01110330|P2|Participant Flow|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
227190|NCT01110330|P1|Participant Flow|Placebo|A topical white homogenous cream identical in appearance to study drug
227191|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
227192|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
227193|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
227194|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
227195|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
227196|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
227197|NCT01110330|E3|Reported Event|Placebo|A topical white homogenous cream identical in appearance to study drug
227198|NCT01110330|E2|Reported Event|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
227199|NCT01110330|E1|Reported Event|Ketoconazole|Ketoconazole 2% cream (formulation F126)
227200|NCT01110252|B1|Baseline|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
227201|NCT01110252|P1|Participant Flow|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
227202|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
227203|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
227204|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
227205|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
227206|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
227207|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
227208|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
227209|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
227210|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
227211|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
227212|NCT01110252|E1|Reported Event|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
227213|NCT01110239|B5|Baseline|Total|Total of all reporting groups
227214|NCT01110239|B4|Baseline|10 Min Ischemia|
227215|NCT01110239|B3|Baseline|7.5 Min Ischemia|
227216|NCT01110239|B2|Baseline|5 Min Ischemia|
227217|NCT01110239|B1|Baseline|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
227218|NCT01110239|P4|Participant Flow|10-min Ischemia|
227219|NCT01110239|P3|Participant Flow|7.5-min Ischemia|
227220|NCT01110239|P2|Participant Flow|5-min Ischemia|
227282|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
227221|NCT01110239|P1|Participant Flow|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
227222|NCT01110239|O4|Outcome|10 Min Ischemia|
227223|NCT01110239|O3|Outcome|7.5 Min Ischemia|
227224|NCT01110239|O2|Outcome|5 Min Ischemia|
227225|NCT01110239|O1|Outcome|Sham Preconditioning|Limb preconditioning intervention at increasing durations of ischemia: 5, 7.5 and 10 min.
227226|NCT01110239|O4|Outcome|10 Min Ischemia|
227227|NCT01110239|O3|Outcome|7.5 Min Ischemia|
227228|NCT01110239|O2|Outcome|5 Min Ischemia|
227229|NCT01110239|O1|Outcome|Sham Preconditioning|leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
227230|NCT01110239|E4|Reported Event|10 Min Ischemia|
227231|NCT01110239|E3|Reported Event|7.5 Min Ischemia|
227232|NCT01110239|E2|Reported Event|5 Min Ischemia|
227233|NCT01110239|E1|Reported Event|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
227234|NCT01110200|B3|Baseline|Total|Total of all reporting groups
227235|NCT01110200|B2|Baseline|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227236|NCT01110200|B1|Baseline|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227237|NCT01110200|P2|Participant Flow|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227238|NCT01110200|P1|Participant Flow|FSC 250/50|Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227239|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227240|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227241|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227242|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227243|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227244|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227245|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227246|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227247|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227248|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227249|NCT01110200|E2|Reported Event|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227250|NCT01110200|E1|Reported Event|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
227251|NCT01110187|B3|Baseline|Total|Total of all reporting groups
227252|NCT01110187|B2|Baseline|IV fPHT|patients randomized to IV fPHT (4)
227253|NCT01110187|B1|Baseline|IV LCM|patients randomized to IV LCM (7)
227254|NCT01110187|P2|Participant Flow|IV fPHT|"Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see Intervention section."
227255|NCT01110187|P1|Participant Flow|IV LCM|"Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see Intervention section."
227256|NCT01110187|O2|Outcome|IV fPHT|"Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin~Fosphenytoin: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days"
227348|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227257|NCT01110187|O1|Outcome|IV LCM|"Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.~lacosamide: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose."
227258|NCT01110187|O2|Outcome|IV fPHT|Patients with severe TBI randomized to seizure prophylaxis with fPHT
227259|NCT01110187|O1|Outcome|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
227260|NCT01110187|E2|Reported Event|IV fPHT|Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
227261|NCT01110187|E1|Reported Event|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
227262|NCT01109979|B3|Baseline|Total|Total of all reporting groups
227263|NCT01109979|B2|Baseline|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
227264|NCT01109979|B1|Baseline|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
227265|NCT01109979|P2|Participant Flow|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
227266|NCT01109979|P1|Participant Flow|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
227267|NCT01109979|O2|Outcome|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
227268|NCT01109979|O1|Outcome|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
227269|NCT01109979|E2|Reported Event|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
227270|NCT01109979|E1|Reported Event|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
227271|NCT01109602|B4|Baseline|Total|Total of all reporting groups
227272|NCT01109602|B3|Baseline|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
227273|NCT01109602|B2|Baseline|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227274|NCT01109602|B1|Baseline|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227275|NCT01109602|P3|Participant Flow|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
227276|NCT01109602|P2|Participant Flow|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227277|NCT01109602|P1|Participant Flow|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227278|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
227279|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
227280|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
227281|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
227387|NCT01109147|O3|Outcome|Control|healthy volunteers
227283|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
227284|NCT01109602|E3|Reported Event|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
227285|NCT01109602|E2|Reported Event|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227286|NCT01109602|E1|Reported Event|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
227287|NCT01109576|B1|Baseline|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
227288|NCT01109576|P1|Participant Flow|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.~Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures."
227289|NCT01109576|O1|Outcome|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
227290|NCT01109576|E1|Reported Event|DSL Workshop Participants|"Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
227291|NCT01109524|B1|Baseline|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227292|NCT01109524|P1|Participant Flow|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227293|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227294|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227349|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227295|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227296|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227297|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227298|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227299|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227300|NCT01109524|E1|Reported Event|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
227301|NCT01109381|B1|Baseline|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
227302|NCT01109381|P1|Participant Flow|GT08|"Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
227303|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC (N-acetyl cysteine), lauric acid with dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
227304|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
227350|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227305|NCT01109381|O1|Outcome|Treatment With GT08|"Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily"
227306|NCT01109381|E1|Reported Event|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
227307|NCT01109316|B7|Baseline|Total|Total of all reporting groups
227308|NCT01109316|B6|Baseline|A6D/L6D/L2D|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
227309|NCT01109316|B5|Baseline|A6D/L2D/L6D|Insulin Aspart 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227310|NCT01109316|B4|Baseline|L6D/A6D/L2D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
227311|NCT01109316|B3|Baseline|L6D/L2D/A6D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227312|NCT01109316|B2|Baseline|L2D/A6D/L6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227313|NCT01109316|B1|Baseline|L2D/L6D/A6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227314|NCT01109316|P3|Participant Flow|Insulin Aspart 6 Day (A6D)|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
227315|NCT01109316|P2|Participant Flow|Insulin Lispro 6 Day (L6D)|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
227316|NCT01109316|P1|Participant Flow|Insulin Lispro 2 Day (L2D)|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
227317|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227318|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227319|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227320|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227321|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227322|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227323|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227324|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227325|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227326|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227327|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227328|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227329|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227330|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227331|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227332|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227333|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227334|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227335|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227336|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227337|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227338|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227339|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227340|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227341|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227342|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227343|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227344|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227345|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227346|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227347|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227353|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227354|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227355|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227356|NCT01109316|E3|Reported Event|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
227357|NCT01109316|E2|Reported Event|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
227358|NCT01109316|E1|Reported Event|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
227359|NCT01109173|B5|Baseline|Total|Total of all reporting groups
227360|NCT01109173|B4|Baseline|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227361|NCT01109173|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227362|NCT01109173|B2|Baseline|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227363|NCT01109173|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227364|NCT01109173|P4|Participant Flow|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227365|NCT01109173|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227366|NCT01109173|P2|Participant Flow|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227367|NCT01109173|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227368|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227369|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227370|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227371|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227372|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227373|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227374|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227375|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227376|NCT01109173|E4|Reported Event|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227377|NCT01109173|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227378|NCT01109173|E2|Reported Event|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
227379|NCT01109173|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
227380|NCT01109147|B4|Baseline|Total|Total of all reporting groups
227381|NCT01109147|B3|Baseline|Control|healthy volunteers
227382|NCT01109147|B2|Baseline|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
227383|NCT01109147|B1|Baseline|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
227384|NCT01109147|P3|Participant Flow|Control|healthy volunteers
227385|NCT01109147|P2|Participant Flow|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
227386|NCT01109147|P1|Participant Flow|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
227388|NCT01109147|O2|Outcome|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
227389|NCT01109147|O1|Outcome|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
227390|NCT01109147|E3|Reported Event|Control|healthy volunteers
227391|NCT01109147|E2|Reported Event|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
227392|NCT01109147|E1|Reported Event|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
227393|NCT01109056|B3|Baseline|Total|Total of all reporting groups
227394|NCT01109056|B2|Baseline|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227395|NCT01109056|B1|Baseline|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227396|NCT01109056|P2|Participant Flow|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227397|NCT01109056|P1|Participant Flow|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227398|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227399|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227400|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227401|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227402|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227403|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227404|NCT01109056|E2|Reported Event|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
227405|NCT01109056|E1|Reported Event|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
227406|NCT01108809|B1|Baseline|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227407|NCT01108809|P1|Participant Flow|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227408|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
227409|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
227410|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227411|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227412|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227413|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227414|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227415|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227416|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227417|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227418|NCT01108809|E1|Reported Event|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
227419|NCT01108796|B5|Baseline|Total|Total of all reporting groups
227420|NCT01108796|B4|Baseline|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227421|NCT01108796|B3|Baseline|Tool (With Lifestyle Education Tool on Weight Reduction)|
227422|NCT01108796|B2|Baseline|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227423|NCT01108796|B1|Baseline|Micardis® (Telmisartan)|Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
227424|NCT01108796|P2|Participant Flow|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
227425|NCT01108796|P1|Participant Flow|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
227426|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227427|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227428|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227429|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227430|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227431|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227432|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227433|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227434|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227435|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227436|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227437|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227438|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227439|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227440|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227441|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227442|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227443|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227444|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227445|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227446|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227447|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227448|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
227449|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
227450|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
227451|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
227454|NCT01108796|E2|Reported Event|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
227455|NCT01108796|E1|Reported Event|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
227456|NCT01108731|B3|Baseline|Total|Total of all reporting groups
227457|NCT01108731|B2|Baseline|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227458|NCT01108731|B1|Baseline|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227459|NCT01108731|P2|Participant Flow|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227460|NCT01108731|P1|Participant Flow|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227461|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227462|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227463|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227464|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227465|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227466|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227467|NCT01108731|E2|Reported Event|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
227468|NCT01108731|E1|Reported Event|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
227469|NCT01108718|B3|Baseline|Total|Total of all reporting groups
227470|NCT01108718|B2|Baseline|Subjects Who Receive the Control Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
227471|NCT01108718|B1|Baseline|Subjects Who Receive Tempur-Pedic Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
227472|NCT01108718|P2|Participant Flow|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
227473|NCT01108718|P1|Participant Flow|Subjects Who Received the Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
227474|NCT01108718|O1|Outcome|All Participants|All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
227475|NCT01108718|E2|Reported Event|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
227476|NCT01108718|E1|Reported Event|Subjects Who Received Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
227477|NCT01108523|B1|Baseline|HP828-101|HP828-101 Experimental Formulation
227478|NCT01108523|P1|Participant Flow|HP828-101|HP828-101 Experimental Formulation
227479|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
227480|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
227481|NCT01108523|E1|Reported Event|HP828-101|HP828-101 Experimental Formulation
227482|NCT01108510|B3|Baseline|Total|Total of all reporting groups
227483|NCT01108510|B2|Baseline|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227484|NCT01108510|B1|Baseline|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227485|NCT01108510|P2|Participant Flow|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227486|NCT01108510|P1|Participant Flow|ATV+COBI+FTC/TDF|Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
227487|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227488|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227489|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227490|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227491|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227492|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227493|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227494|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227495|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227496|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227497|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227498|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227499|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227500|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227501|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227502|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227503|NCT01108510|E2|Reported Event|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227504|NCT01108510|E1|Reported Event|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
227505|NCT01108445|B3|Baseline|Total|Total of all reporting groups
227506|NCT01108445|B2|Baseline|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227507|NCT01108445|B1|Baseline|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227508|NCT01108445|P2|Participant Flow|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227509|NCT01108445|P1|Participant Flow|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227510|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227511|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227512|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227513|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227514|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227515|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227516|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227517|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227518|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227519|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227520|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227521|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227522|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227523|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227708|NCT01107899|P3|Participant Flow|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227524|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227525|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227526|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227527|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227528|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227529|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227530|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227531|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227532|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227533|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227534|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227535|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227536|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227537|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227538|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227539|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227540|NCT01108445|E2|Reported Event|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
227541|NCT01108445|E1|Reported Event|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
227542|NCT01108406|B1|Baseline|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
227543|NCT01108406|P1|Participant Flow|Sonitus SoundBite System|Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
227544|NCT01108406|O2|Outcome|Global Benefit APHAB Score Aided 6 Months|The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
227545|NCT01108406|O1|Outcome|Global Benefit APHAB Score Aided 3 Months|The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
227546|NCT01108406|O1|Outcome|Number of Participants Experiencing no Adverse Events|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
227547|NCT01108406|E1|Reported Event|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
227574|NCT01108185|P1|Participant Flow|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227548|NCT01108341|B1|Baseline|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
227549|NCT01108341|P1|Participant Flow|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
227550|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
227551|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
227552|NCT01108341|E1|Reported Event|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
227553|NCT01108263|B3|Baseline|Total|Total of all reporting groups
227554|NCT01108263|B2|Baseline|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227555|NCT01108263|B1|Baseline|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227556|NCT01108263|P2|Participant Flow|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227557|NCT01108263|P1|Participant Flow|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227558|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227559|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227560|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227561|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227562|NCT01108263|E2|Reported Event|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227563|NCT01108263|E1|Reported Event|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
227564|NCT01108237|B3|Baseline|Total|Total of all reporting groups
227565|NCT01108237|B2|Baseline|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
227566|NCT01108237|B1|Baseline|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
227567|NCT01108237|P2|Participant Flow|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
227568|NCT01108237|P1|Participant Flow|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
227569|NCT01108237|O2|Outcome|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
227570|NCT01108237|O1|Outcome|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
227571|NCT01108237|E2|Reported Event|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
227572|NCT01108237|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
227573|NCT01108185|B1|Baseline|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227709|NCT01107899|P2|Participant Flow|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227575|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227576|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227577|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227578|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227579|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227580|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227581|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227582|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227583|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227584|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227585|NCT01108185|E1|Reported Event|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
227586|NCT01108081|B5|Baseline|Total|Total of all reporting groups
227587|NCT01108081|B4|Baseline|Combined Physical Activity/Diet|Combined physical activity and diet
227588|NCT01108081|B3|Baseline|Health Education|"Health education~Health education: Attention control intervention"
227589|NCT01108081|B2|Baseline|Diet|"Diet~Diet: Dietary weight loss"
227590|NCT01108081|B1|Baseline|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
227591|NCT01108081|P4|Participant Flow|Combined Physical Activity/Diet|Combined physical activity and diet
227592|NCT01108081|P3|Participant Flow|Health Education|"Health education~Health education: Attention control intervention"
227593|NCT01108081|P2|Participant Flow|Diet|"Diet~Diet: Dietary weight loss"
227594|NCT01108081|P1|Participant Flow|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
227595|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
227596|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
227597|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
227598|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
227599|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
227600|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
227601|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
227602|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
227603|NCT01108081|E4|Reported Event|Combined Physical Activity/Diet|Combined physical activity and diet
227604|NCT01108081|E3|Reported Event|Health Education|"Health education~Health education: Attention control intervention"
227605|NCT01108081|E2|Reported Event|Diet|"Diet~Diet: Dietary weight loss"
227606|NCT01108081|E1|Reported Event|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
227607|NCT01108003|B3|Baseline|Total|Total of all reporting groups
227608|NCT01108003|B2|Baseline|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
227609|NCT01108003|B1|Baseline|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
227610|NCT01108003|P2|Participant Flow|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
227611|NCT01108003|P1|Participant Flow|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
227612|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
227613|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
227614|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
227615|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
227616|NCT01108003|E2|Reported Event|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
227674|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227617|NCT01108003|E1|Reported Event|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
227618|NCT01107925|B5|Baseline|Total|Total of all reporting groups
227619|NCT01107925|B4|Baseline|Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)|Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
227620|NCT01107925|B3|Baseline|Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
227621|NCT01107925|B2|Baseline|Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)|Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3.
227622|NCT01107925|B1|Baseline|Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3.
227623|NCT01107925|P6|Participant Flow|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227624|NCT01107925|P5|Participant Flow|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227625|NCT01107925|P4|Participant Flow|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227626|NCT01107925|P3|Participant Flow|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
227627|NCT01107925|P2|Participant Flow|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227628|NCT01107925|P1|Participant Flow|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227629|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227630|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227631|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227632|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
227633|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227634|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227635|NCT01107925|O6|Outcome|Clopidogrel 75 mg (HBW)|Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227636|NCT01107925|O5|Outcome|Prasugrel 10 mg (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227637|NCT01107925|O4|Outcome|Prasugrel 5 mg (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227638|NCT01107925|O3|Outcome|Clopidogrel 75 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227639|NCT01107925|O2|Outcome|Prasugrel 10 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227640|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227641|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
227642|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227643|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227644|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
227645|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227646|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227647|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
227648|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227649|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227650|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
227651|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227652|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227653|NCT01107925|O2|Outcome|Prasugrel 10 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
227654|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
227655|NCT01107925|E6|Reported Event|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227656|NCT01107925|E5|Reported Event|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
227657|NCT01107925|E4|Reported Event|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227658|NCT01107925|E3|Reported Event|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
227659|NCT01107925|E2|Reported Event|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
227660|NCT01107925|E1|Reported Event|5 mg Prasugrel (LBW)|During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
227661|NCT01107912|B5|Baseline|Total|Total of all reporting groups
227662|NCT01107912|B4|Baseline|Non-Elderly; Drug Sequence BCA|Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
227663|NCT01107912|B3|Baseline|Non-Elderly; Drug Sequence BAC|Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
227664|NCT01107912|B2|Baseline|Very Elderly; Drug Sequence ACB|Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
227665|NCT01107912|B1|Baseline|Very Elderly, Drug Sequence ABC|Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
227666|NCT01107912|P6|Participant Flow|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227667|NCT01107912|P5|Participant Flow|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227668|NCT01107912|P4|Participant Flow|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227669|NCT01107912|P3|Participant Flow|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227670|NCT01107912|P2|Participant Flow|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227671|NCT01107912|P1|Participant Flow|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227672|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227673|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227707|NCT01107899|B1|Baseline|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227675|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227676|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227677|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227678|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227679|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227680|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227681|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227682|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227683|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227684|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227685|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227686|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227687|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227688|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227689|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227690|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227691|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227692|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227693|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227694|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227695|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227696|NCT01107912|O2|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227697|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227698|NCT01107912|E6|Reported Event|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227699|NCT01107912|E5|Reported Event|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227700|NCT01107912|E4|Reported Event|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
227701|NCT01107912|E3|Reported Event|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
227702|NCT01107912|E2|Reported Event|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
227703|NCT01107912|E1|Reported Event|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
227704|NCT01107899|B4|Baseline|Total|Total of all reporting groups
227705|NCT01107899|B3|Baseline|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227706|NCT01107899|B2|Baseline|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
228524|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
227710|NCT01107899|P1|Participant Flow|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227711|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227712|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227713|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227714|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227715|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227716|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227717|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227718|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227719|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227720|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227721|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227722|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227723|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227724|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227725|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227726|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227727|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227728|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227729|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227730|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227731|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227732|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227733|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227734|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227735|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227736|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227737|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227738|NCT01107899|O1|Outcome|All Treatments|"Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose~All treatments were combined into one group."
227739|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227740|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227741|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227742|NCT01107899|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227743|NCT01107899|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227744|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227745|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227746|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227747|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227748|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227749|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227750|NCT01107899|E3|Reported Event|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
227751|NCT01107899|E2|Reported Event|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
227752|NCT01107899|E1|Reported Event|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
227753|NCT01107886|B3|Baseline|Total|Total of all reporting groups
227754|NCT01107886|B2|Baseline|Placebo|Matching Placebo
227755|NCT01107886|B1|Baseline|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227756|NCT01107886|P2|Participant Flow|Placebo|Matching Placebo
227757|NCT01107886|P1|Participant Flow|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227758|NCT01107886|O2|Outcome|Placebo|Matching Placebo
227759|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227760|NCT01107886|O2|Outcome|Placebo|Matching Placebo
227761|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227762|NCT01107886|O2|Outcome|Placebo|Matching Placebo
227763|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227764|NCT01107886|E2|Reported Event|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
227765|NCT01107886|E1|Reported Event|Placebo|Matching Placebo
227766|NCT01107834|B3|Baseline|Total|Total of all reporting groups
227767|NCT01107834|B2|Baseline|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227768|NCT01107834|B1|Baseline|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227769|NCT01107834|P2|Participant Flow|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227770|NCT01107834|P1|Participant Flow|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227771|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227772|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227773|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227774|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227775|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227776|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227777|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227778|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227779|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227780|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227781|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
227782|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
227783|NCT01107834|E2|Reported Event|Exposed to HIV/HAART|"HIV-negative children exposed to HIV and HAART in utero~No adverse events"
227784|NCT01107834|E1|Reported Event|Healthy Control|"HIV-negative children born to healthy, HIV-negative women~No adverse events"
227785|NCT01107743|B1|Baseline|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227786|NCT01107743|P1|Participant Flow|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227787|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227788|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227789|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227790|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227791|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227792|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227793|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227794|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227795|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
227796|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227797|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227798|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227799|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227800|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227801|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227802|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227803|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227804|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227805|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227806|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227807|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227808|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227809|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227810|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227811|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227812|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227813|NCT01107743|O4|Outcome|Class4|Participants with Class4 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227814|NCT01107743|O3|Outcome|Class3|Participants with Class3 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227815|NCT01107743|O2|Outcome|Class2|Participants with Class2 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227816|NCT01107743|O1|Outcome|Class1|Participants with Class1 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227817|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227818|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227819|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227820|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227821|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227822|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227823|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227824|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227825|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227826|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227827|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227828|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227829|NCT01107743|O3|Outcome|ClassⅢ|Participants with Class Ⅲ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227830|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
227831|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227832|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227833|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227834|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
227835|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
227836|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227837|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227838|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227839|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227840|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227841|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227842|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227843|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227844|NCT01107743|O2|Outcome|With Familial Hypercholesterolemia|Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227845|NCT01107743|O1|Outcome|Without Familial Hypercholesterolemia|Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227846|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
227847|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227848|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227849|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227850|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227851|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227852|NCT01107743|O2|Outcome|With Hypercholesterolemia|Participants with Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227853|NCT01107743|O1|Outcome|Without Hypercholesterolemia|Participants without Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227854|NCT01107743|O2|Outcome|With Angina Pectoris|Participants with Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227855|NCT01107743|O1|Outcome|Without Angina Pectoris|Participants without Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227856|NCT01107743|O3|Outcome|ClassⅢ|Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227857|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227858|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227859|NCT01107743|O2|Outcome|With Hypertension|Participants with Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227860|NCT01107743|O1|Outcome|Without Hypertension|Participants without Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227861|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227862|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227863|NCT01107743|O2|Outcome|Female|Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227864|NCT01107743|O1|Outcome|Male|Male participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227865|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227866|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227867|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227868|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227869|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227870|NCT01107743|E1|Reported Event|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
227871|NCT01107730|B4|Baseline|Total|Total of all reporting groups
227872|NCT01107730|B3|Baseline|Placebo|Placebo: Placebo
227873|NCT01107730|B2|Baseline|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
227874|NCT01107730|B1|Baseline|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
227875|NCT01107730|P3|Participant Flow|Placebo|Placebo: Placebo
227876|NCT01107730|P2|Participant Flow|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
227877|NCT01107730|P1|Participant Flow|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
227878|NCT01107730|O3|Outcome|Placebo|Placebo: Placebo
227879|NCT01107730|O2|Outcome|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
227880|NCT01107730|O1|Outcome|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
227881|NCT01107730|E3|Reported Event|Placebo|Placebo: Placebo
227882|NCT01107730|E2|Reported Event|Vitamin C|"Vitamin C 2 days preoperatively and 4 days postoperatively~Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively"
227883|NCT01107730|E1|Reported Event|L-Carnitine|"Carnitine 2 days preoperatively and 4 days postoperatively~Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively"
227884|NCT01107535|B1|Baseline|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227885|NCT01107535|P1|Participant Flow|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227971|NCT01107405|P4|Participant Flow|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227972|NCT01107405|P3|Participant Flow|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227973|NCT01107405|P2|Participant Flow|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227886|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227887|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227888|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227889|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227890|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227891|NCT01107535|E1|Reported Event|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
227892|NCT01107418|B5|Baseline|Total|Total of all reporting groups
227893|NCT01107418|B4|Baseline|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227894|NCT01107418|B3|Baseline|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227895|NCT01107418|B2|Baseline|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227896|NCT01107418|B1|Baseline|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227897|NCT01107418|P1|Participant Flow|Vemurafenib – All Cohorts|Participants received vemurafenib (RO5185426) film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 milligrams (mg) on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227898|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227899|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227900|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227901|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227902|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227903|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227904|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227905|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227906|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227907|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227908|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227909|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227910|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227911|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227912|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227913|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227914|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227915|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227916|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227917|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
228525|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
227918|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227919|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227920|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227921|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227922|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227923|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227924|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227925|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227926|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227927|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227928|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227929|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227930|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227931|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227932|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227933|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227974|NCT01107405|P1|Participant Flow|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227934|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227935|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227936|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227937|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227938|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227939|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227940|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227941|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227942|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227943|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227944|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227945|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227946|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227947|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227948|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227949|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227975|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227950|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227951|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227952|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227953|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227954|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227955|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227956|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227957|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227958|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227959|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227960|NCT01107418|E4|Reported Event|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227961|NCT01107418|E3|Reported Event|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227962|NCT01107418|E2|Reported Event|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227963|NCT01107418|E1|Reported Event|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
227964|NCT01107405|B6|Baseline|Total|Total of all reporting groups
227965|NCT01107405|B5|Baseline|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227966|NCT01107405|B4|Baseline|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227967|NCT01107405|B3|Baseline|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227968|NCT01107405|B2|Baseline|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227969|NCT01107405|B1|Baseline|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227970|NCT01107405|P5|Participant Flow|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
228526|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
227976|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227977|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227978|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227979|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227980|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227981|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227982|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227983|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227984|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227985|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227986|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227987|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227988|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227989|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227990|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227991|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227992|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227993|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227994|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
227995|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
227996|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
227997|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
227998|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
227999|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
228000|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
228001|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
228002|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
228003|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
228004|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
228005|NCT01107405|E5|Reported Event|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
228006|NCT01107405|E4|Reported Event|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
228007|NCT01107405|E3|Reported Event|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
228008|NCT01107405|E2|Reported Event|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
228009|NCT01107405|E1|Reported Event|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
228010|NCT01107392|B3|Baseline|Total|Total of all reporting groups
228011|NCT01107392|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228012|NCT01107392|B1|Baseline|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228013|NCT01107392|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228014|NCT01107392|P1|Participant Flow|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228015|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228016|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228017|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228018|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228019|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228020|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228021|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228022|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228023|NCT01107392|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
228024|NCT01107392|E1|Reported Event|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
228025|NCT01107379|B1|Baseline|Balloon Catheter Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation"
228026|NCT01107379|P1|Participant Flow|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228027|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228028|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228029|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228030|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228031|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228032|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228033|NCT01107379|E1|Reported Event|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
228034|NCT01107353|B3|Baseline|Total|Total of all reporting groups
228035|NCT01107353|B2|Baseline|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228036|NCT01107353|B1|Baseline|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228037|NCT01107353|P2|Participant Flow|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228038|NCT01107353|P1|Participant Flow|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228039|NCT01107353|O2|Outcome|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228040|NCT01107353|O1|Outcome|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228041|NCT01107353|E2|Reported Event|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228042|NCT01107353|E1|Reported Event|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
228043|NCT01107197|B3|Baseline|Total|Total of all reporting groups
228044|NCT01107197|B2|Baseline|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228045|NCT01107197|B1|Baseline|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228046|NCT01107197|P2|Participant Flow|Enriched Nutrition Formula|"Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228047|NCT01107197|P1|Participant Flow|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks~Control formula : Isonitrogenous isocaloric oral formula"
228048|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228049|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228050|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228051|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228052|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228053|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228054|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228055|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228056|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228090|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228057|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228058|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228059|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228060|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228061|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228062|NCT01107197|E2|Reported Event|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
228063|NCT01107197|E1|Reported Event|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
228064|NCT01106976|B1|Baseline|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients
228065|NCT01106976|P1|Participant Flow|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent [C-11]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
228066|NCT01106976|O1|Outcome|Parkinson Disease|Prospective cohort study of Parkinson disease subjects.
228067|NCT01106976|E1|Reported Event|Parkinson|Longitudinal cohort
228068|NCT01106950|B1|Baseline|Evaluable (Treated) Patients|Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228069|NCT01106950|P1|Participant Flow|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228070|NCT01106950|O2|Outcome|Evaluable (Treated) Patients (Expansion=Yes)|KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228071|NCT01106950|O1|Outcome|Evaluable (Treated) Patients (Expansion=No)|KIR matched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228072|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228073|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228074|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228075|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228076|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228077|NCT01106950|E1|Reported Event|Treated Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
228078|NCT01106911|B1|Baseline|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
228079|NCT01106911|P1|Participant Flow|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
228080|NCT01106911|O1|Outcome|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
228081|NCT01106911|E1|Reported Event|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
228082|NCT01106859|B1|Baseline|Total Population|All participants in this four-way cross-over study
228083|NCT01106859|P1|Participant Flow|Total Population|All participants in this four-way cross-over study
228084|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228085|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228086|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228087|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228088|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228089|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228091|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228092|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228093|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228094|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228095|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228096|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228097|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228098|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228099|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228100|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228101|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228102|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228103|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228104|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228105|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228106|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228107|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228108|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228109|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228110|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228111|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228112|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228113|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228114|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228115|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228116|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228117|NCT01106859|E4|Reported Event|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
228118|NCT01106859|E3|Reported Event|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
228119|NCT01106859|E2|Reported Event|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
228120|NCT01106859|E1|Reported Event|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
228121|NCT01106846|B3|Baseline|Total|Total of all reporting groups
228122|NCT01106846|B2|Baseline|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
228123|NCT01106846|B1|Baseline|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
228124|NCT01106846|P2|Participant Flow|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
228125|NCT01106846|P1|Participant Flow|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
228126|NCT01106846|O2|Outcome|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
228127|NCT01106846|O1|Outcome|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
228128|NCT01106846|E2|Reported Event|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
228129|NCT01106846|E1|Reported Event|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
228130|NCT01106690|B4|Baseline|Total|Total of all reporting groups
228131|NCT01106690|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228132|NCT01106690|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228133|NCT01106690|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228134|NCT01106690|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228135|NCT01106690|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228136|NCT01106690|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228137|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228138|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228139|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228140|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228141|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228142|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228143|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228144|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228145|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228146|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228147|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228148|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228149|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228150|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228151|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228152|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228153|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228154|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228155|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228156|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228157|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228158|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228159|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
228193|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228160|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
228161|NCT01106690|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
228162|NCT01106690|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
228163|NCT01106690|E4|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.
228164|NCT01106690|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
228165|NCT01106690|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
228166|NCT01106690|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.
228167|NCT01106677|B5|Baseline|Total|Total of all reporting groups
228168|NCT01106677|B4|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228169|NCT01106677|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228170|NCT01106677|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228171|NCT01106677|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228172|NCT01106677|P4|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228173|NCT01106677|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228174|NCT01106677|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228175|NCT01106677|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228176|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228177|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228178|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228179|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228180|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228181|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228182|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228183|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228184|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228185|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228186|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228187|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228188|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228189|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228190|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228191|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228192|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228292|NCT01106625|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228194|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228195|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228196|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228197|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228198|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228199|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228200|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228201|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228202|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228203|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228204|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228205|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228206|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228207|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228208|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228209|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228210|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228211|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228212|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228213|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228214|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228215|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228216|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228217|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228218|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228219|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228220|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228221|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228222|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228223|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228224|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
228225|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
228226|NCT01106677|E8|Reported Event|Sitagliptin 100mg: Baseline to Week 52|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
228527|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
228227|NCT01106677|E7|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
228228|NCT01106677|E6|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
228229|NCT01106677|E5|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
228230|NCT01106677|E4|Reported Event|Sitagliptin 100 mg: Baseline to Week 26|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
228231|NCT01106677|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
228232|NCT01106677|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
228233|NCT01106677|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
228234|NCT01106651|B4|Baseline|Total|Total of all reporting groups
228235|NCT01106651|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228236|NCT01106651|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228237|NCT01106651|B1|Baseline|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228238|NCT01106651|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228239|NCT01106651|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228240|NCT01106651|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228241|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228242|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228243|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228244|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228245|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228246|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228247|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228248|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228249|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228250|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228251|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228252|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228253|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228254|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228255|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228256|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228257|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228258|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228259|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228260|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228261|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228262|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228263|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228264|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228265|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228266|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228267|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228268|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228269|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228270|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228271|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228272|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228273|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228274|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228275|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228276|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228277|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228278|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228279|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228280|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228281|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228282|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
228283|NCT01106651|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
228284|NCT01106651|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
228285|NCT01106651|E4|Reported Event|Placebo: Baseline to Week 104|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
228286|NCT01106651|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
228287|NCT01106651|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
228288|NCT01106651|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
228289|NCT01106625|B4|Baseline|Total|Total of all reporting groups
228290|NCT01106625|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228291|NCT01106625|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228293|NCT01106625|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228294|NCT01106625|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228295|NCT01106625|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228296|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228297|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228298|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228299|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228300|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228301|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228302|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228303|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228304|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228305|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228306|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228307|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228308|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228309|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228310|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228311|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228312|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228313|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228314|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228315|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228316|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
228317|NCT01106625|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
228318|NCT01106625|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
228319|NCT01106625|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
228320|NCT01106625|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
228321|NCT01106625|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
228322|NCT01106625|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
228323|NCT01106586|B3|Baseline|Total|Total of all reporting groups
228324|NCT01106586|B2|Baseline|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228325|NCT01106586|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228326|NCT01106586|P2|Participant Flow|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228327|NCT01106586|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
228328|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228329|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228330|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228331|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228332|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228333|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228334|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228335|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228336|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228337|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228338|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228339|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228340|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228341|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228342|NCT01106586|E2|Reported Event|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
228343|NCT01106586|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
228344|NCT01106534|B1|Baseline|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
228345|NCT01106534|P1|Participant Flow|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
228346|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228347|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228348|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228349|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228350|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228351|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228352|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228401|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
228353|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228354|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228355|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228356|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228357|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228358|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228359|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228360|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228361|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228362|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
228363|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
228364|NCT01106534|E1|Reported Event|Second Enrollment Phase of XIENCE V® USA|The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
228365|NCT01106430|B3|Baseline|Total|Total of all reporting groups
228366|NCT01106430|B2|Baseline|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228367|NCT01106430|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228368|NCT01106430|P2|Participant Flow|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228369|NCT01106430|P1|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228370|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228371|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228372|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228373|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228374|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228375|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228376|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228377|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228378|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228379|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228380|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228381|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228382|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228383|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228384|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228385|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228386|NCT01106430|E2|Reported Event|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
228387|NCT01106430|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
228388|NCT01106404|B3|Baseline|Total|Total of all reporting groups
228389|NCT01106404|B2|Baseline|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
228390|NCT01106404|B1|Baseline|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
228391|NCT01106404|P2|Participant Flow|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
228392|NCT01106404|P1|Participant Flow|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
228393|NCT01106404|O4|Outcome|NPRS at 16 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
228394|NCT01106404|O3|Outcome|NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
228395|NCT01106404|O2|Outcome|NPRS at 10 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
228396|NCT01106404|O1|Outcome|NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
228397|NCT01106404|O2|Outcome|Manual Treatment Arm|Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.
228398|NCT01106404|O1|Outcome|AdaptiveStim Treatment Arm|Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.
228399|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStime Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
228400|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
228991|NCT01104584|O1|Outcome|CMRM Versus UMRM|
228402|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
228403|NCT01106404|E1|Reported Event|Overall Adverse Events|Overall adverse events were reported.
228404|NCT01106391|B1|Baseline|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
228405|NCT01106391|P1|Participant Flow|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
228406|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
228407|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
228408|NCT01106391|E1|Reported Event|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
228409|NCT01106352|B6|Baseline|Total|Total of all reporting groups
228410|NCT01106352|B5|Baseline|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228411|NCT01106352|B4|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228412|NCT01106352|B3|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228413|NCT01106352|B2|Baseline|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228414|NCT01106352|B1|Baseline|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228415|NCT01106352|P5|Participant Flow|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228416|NCT01106352|P4|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228417|NCT01106352|P3|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228418|NCT01106352|P2|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228419|NCT01106352|P1|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228420|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228421|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228422|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228423|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228992|NCT01104584|O1|Outcome|CMRM|
228424|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228425|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228426|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228427|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228428|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228429|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228430|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228431|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228432|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228433|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228434|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228435|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228436|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228437|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228438|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228439|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228440|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228441|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228442|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228443|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228444|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228445|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228446|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228447|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228448|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228520|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
228521|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
228993|NCT01104584|O1|Outcome|CMRM|
228449|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228450|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228451|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228452|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228453|NCT01106352|O3|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228454|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228455|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228456|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228457|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228458|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228459|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228460|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228461|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228462|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228463|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228464|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228465|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228466|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228467|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228468|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228469|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228522|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
228523|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
228994|NCT01104584|O1|Outcome|CMRM|
228470|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228471|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228472|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228473|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228474|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228475|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228476|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228477|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228478|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228479|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228480|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228481|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228482|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228483|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228484|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228485|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228486|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228487|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228488|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228489|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228490|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228491|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
228995|NCT01104584|O1|Outcome|CMRM Versus UMRM|
228492|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228493|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228494|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228495|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228496|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228497|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228498|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
228499|NCT01106352|E5|Reported Event|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks
228500|NCT01106352|E4|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
228501|NCT01106352|E3|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228502|NCT01106352|E2|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
228503|NCT01106352|E1|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
228504|NCT01106326|B1|Baseline|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
228505|NCT01106326|P1|Participant Flow|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
228506|NCT01106326|O3|Outcome|Four Months Post Baseline|
228507|NCT01106326|O2|Outcome|Two Months Post Baseline|
228508|NCT01106326|O1|Outcome|Baseline|
228509|NCT01106326|E1|Reported Event|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
228510|NCT01106287|B5|Baseline|Total|Total of all reporting groups
228511|NCT01106287|B4|Baseline|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
228512|NCT01106287|B3|Baseline|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
228513|NCT01106287|B2|Baseline|MK-0941 60/80/Pbo/ MK-0941 120/140 mg|Treatment Sequence 2
228514|NCT01106287|B1|Baseline|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
228515|NCT01106287|P4|Participant Flow|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
228516|NCT01106287|P3|Participant Flow|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
228517|NCT01106287|P2|Participant Flow|MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg|Treatment Sequence 2
228518|NCT01106287|P1|Participant Flow|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
228519|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
228996|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
228528|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
228529|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
228530|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
228531|NCT01106287|E6|Reported Event|Placebo|All participants receiving placebo
228532|NCT01106287|E5|Reported Event|MK-0941 140 mg|All participants receiving at least one dose of 140 mg of MK-0941
228533|NCT01106287|E4|Reported Event|MK-0941 120 mg|All participants receiving at least one dose of 120 mg of MK-0941
228534|NCT01106287|E3|Reported Event|MK-0941 100 mg|All participants receiving at least one dose of 100 mg of MK-0941
228535|NCT01106287|E2|Reported Event|MK-0941 80 mg|All participants receiving at least one dose of 80 mg of MK-0941
228536|NCT01106287|E1|Reported Event|MK-0941 60 mg|All participants receiving at least one dose of 60 mg of MK-0941
228537|NCT01106248|B1|Baseline|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228538|NCT01106248|P1|Participant Flow|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228539|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228540|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228541|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228542|NCT01106248|E1|Reported Event|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
228543|NCT01106157|B3|Baseline|Total|Total of all reporting groups
228544|NCT01106157|B2|Baseline|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228545|NCT01106157|B1|Baseline|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228546|NCT01106157|P2|Participant Flow|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner.~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes."
228547|NCT01106157|P1|Participant Flow|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose) given subcutaneously every 2 weeks beginning after the ATG infusion."
228548|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228549|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228550|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228551|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228552|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228553|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228554|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228555|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228556|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228598|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228599|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228557|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228558|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228559|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228560|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228561|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228562|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228563|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228564|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228565|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228566|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228567|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228568|NCT01106157|E2|Reported Event|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
228569|NCT01106157|E1|Reported Event|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
228570|NCT01106040|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
228571|NCT01106040|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
228572|NCT01106040|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
228573|NCT01106040|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
228574|NCT01106040|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
228575|NCT01106014|B3|Baseline|Total|Total of all reporting groups
228576|NCT01106014|B2|Baseline|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
228577|NCT01106014|B1|Baseline|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
228578|NCT01106014|P2|Participant Flow|PLACEBO|Matching placebo was administered orally following the same administration schedule as described for selexipag
228600|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228601|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228579|NCT01106014|P1|Participant Flow|SELEXIPAG|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
228580|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
228581|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
228582|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
228583|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
228584|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
228585|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
228586|NCT01106014|E2|Reported Event|Placebo|This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set.
228587|NCT01106014|E1|Reported Event|Selexipag|This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set.
228588|NCT01105936|B1|Baseline|Total Participants for Baseline Measurement|All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
228589|NCT01105936|P4|Participant Flow|Sequence 4|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
228590|NCT01105936|P3|Participant Flow|Sequence 3|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
228591|NCT01105936|P2|Participant Flow|Sequence 2|Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
228592|NCT01105936|P1|Participant Flow|Sequence 1|Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
228593|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228594|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228595|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228596|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228597|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228602|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228603|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228604|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228605|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228606|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228607|NCT01105936|O1|Outcome|Paracetamol 665 Milligram (mg)|Participants took two 665 mg Paracetamol sustained release caplets orally with 150mL of water.
228608|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228609|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228610|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228611|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
228612|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228613|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228614|NCT01105936|E3|Reported Event|No Treatment|No treatment was given to participants.
228615|NCT01105936|E2|Reported Event|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
228616|NCT01105936|E1|Reported Event|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
228617|NCT01105767|B4|Baseline|Total|Total of all reporting groups
228618|NCT01105767|B3|Baseline|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
228619|NCT01105767|B2|Baseline|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
228620|NCT01105767|B1|Baseline|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency registered disinfectants.
228621|NCT01105767|P3|Participant Flow|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
228622|NCT01105767|P2|Participant Flow|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
228623|NCT01105767|P1|Participant Flow|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard standard Environmental Protection Agency registered disinfectants.
228624|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
228625|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
228626|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
228627|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
228628|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
228674|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228675|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228629|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
228630|NCT01105767|E3|Reported Event|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
228631|NCT01105767|E2|Reported Event|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
228632|NCT01105767|E1|Reported Event|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
228633|NCT01105754|B3|Baseline|Total|Total of all reporting groups
228634|NCT01105754|B2|Baseline|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
228635|NCT01105754|B1|Baseline|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
228636|NCT01105754|P2|Participant Flow|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
228637|NCT01105754|P1|Participant Flow|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
228638|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
228639|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
228640|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
228641|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
228642|NCT01105754|E2|Reported Event|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
228643|NCT01105754|E1|Reported Event|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
228676|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228677|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228678|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228644|NCT01105702|B1|Baseline|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228645|NCT01105702|P1|Participant Flow|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228646|NCT01105702|O2|Outcome|Grade 4|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228647|NCT01105702|O1|Outcome|Grade 3|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228648|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228649|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228650|NCT01105702|E1|Reported Event|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
228651|NCT01105533|B1|Baseline|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228652|NCT01105533|P9|Participant Flow|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228653|NCT01105533|P8|Participant Flow|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228654|NCT01105533|P7|Participant Flow|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228655|NCT01105533|P6|Participant Flow|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228656|NCT01105533|P5|Participant Flow|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228657|NCT01105533|P4|Participant Flow|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228658|NCT01105533|P3|Participant Flow|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228659|NCT01105533|P2|Participant Flow|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228660|NCT01105533|P1|Participant Flow|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228661|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228662|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228663|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228664|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228665|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228666|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228667|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228668|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228669|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228670|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228671|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228672|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228673|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228679|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228680|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228681|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228682|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228683|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228684|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228685|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228686|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228687|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228688|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228689|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228690|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228691|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228692|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228693|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228694|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228695|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228696|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228697|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228698|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228699|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228700|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228701|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228702|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228703|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228704|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228705|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228706|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228707|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228708|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228709|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228710|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228711|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228712|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228713|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228714|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228715|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228716|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228717|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228718|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228719|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228720|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228721|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228722|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228723|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228724|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228725|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228726|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228727|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228728|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228729|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228730|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228731|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228732|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228733|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228734|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228735|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228736|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228737|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
228738|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
228739|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
228740|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
228741|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
228742|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
228743|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
228744|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
228745|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
228746|NCT01105533|E1|Reported Event|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
228747|NCT01105377|B3|Baseline|Total|Total of all reporting groups
228748|NCT01105377|B2|Baseline|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228749|NCT01105377|B1|Baseline|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
228750|NCT01105377|P2|Participant Flow|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228751|NCT01105377|P1|Participant Flow|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
228752|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228753|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
228754|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228755|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
228756|NCT01105377|E2|Reported Event|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
228757|NCT01105377|E1|Reported Event|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
228758|NCT01105247|B3|Baseline|Total|Total of all reporting groups
228759|NCT01105247|B2|Baseline|Food Effect Cohort|PCI-32765: 420 mg daily
228760|NCT01105247|B1|Baseline|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
228761|NCT01105247|P2|Participant Flow|Food Effect Cohort|PCI-32765: 420 mg daily
228762|NCT01105247|P1|Participant Flow|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily.
228763|NCT01105247|O3|Outcome|Food Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
228764|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
228765|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
228766|NCT01105247|O3|Outcome|Food- Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
228767|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
228768|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
228769|NCT01105247|O1|Outcome|Food Effect Cohort|PCI-32765: 420 mg daily
228770|NCT01105247|O2|Outcome|Food Effect|Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
228771|NCT01105247|O1|Outcome|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
228772|NCT01105247|E2|Reported Event|Food Effect|PCI-32765: 420 mg daily
228773|NCT01105247|E1|Reported Event|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
228774|NCT01105130|B4|Baseline|Total|Total of all reporting groups
228775|NCT01105130|B3|Baseline|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228776|NCT01105130|B2|Baseline|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228777|NCT01105130|B1|Baseline|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228778|NCT01105130|P3|Participant Flow|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228779|NCT01105130|P2|Participant Flow|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228780|NCT01105130|P1|Participant Flow|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228781|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228782|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228783|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228784|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228785|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228786|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228787|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228788|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228789|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228790|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228791|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228792|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228793|NCT01105130|E3|Reported Event|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
228794|NCT01105130|E2|Reported Event|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
228795|NCT01105130|E1|Reported Event|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
228796|NCT01105117|B3|Baseline|Total|Total of all reporting groups
228797|NCT01105117|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
228798|NCT01105117|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
228799|NCT01105117|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
228800|NCT01105117|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
228801|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
228802|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
228997|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
228803|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
228804|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
228805|NCT01105117|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
228806|NCT01105117|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
228807|NCT01105091|B3|Baseline|Total|Total of all reporting groups
228808|NCT01105091|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228809|NCT01105091|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228810|NCT01105091|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228811|NCT01105091|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228812|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228813|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228814|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228815|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228816|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228817|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228818|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228819|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228820|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228821|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228822|NCT01105091|O2|Outcome|Flolan (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228823|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228824|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228825|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228826|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228998|NCT01104584|O1|Outcome|CMRM vs UMRM|
228827|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228828|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228829|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228830|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228831|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228832|NCT01105091|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
228833|NCT01105091|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
228834|NCT01105065|B1|Baseline|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
228835|NCT01105065|P1|Participant Flow|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
228836|NCT01105065|O2|Outcome|RVD Patients Post-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
228837|NCT01105065|O1|Outcome|RVD Patients Pre-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
228838|NCT01105065|O1|Outcome|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
228839|NCT01105065|E1|Reported Event|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
228840|NCT01104870|B4|Baseline|Total|Total of all reporting groups
228841|NCT01104870|B3|Baseline|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228842|NCT01104870|B2|Baseline|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228843|NCT01104870|B1|Baseline|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228844|NCT01104870|P3|Participant Flow|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228845|NCT01104870|P2|Participant Flow|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228846|NCT01104870|P1|Participant Flow|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228847|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228848|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228849|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228850|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228851|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228852|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228853|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228854|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228855|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228856|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228857|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228858|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228859|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228860|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228861|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228862|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228863|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228864|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228865|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228866|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228867|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228868|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228869|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228870|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228871|NCT01104870|E3|Reported Event|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
228872|NCT01104870|E2|Reported Event|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
228873|NCT01104870|E1|Reported Event|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
228874|NCT01104701|B5|Baseline|Total|Total of all reporting groups
228875|NCT01104701|B4|Baseline|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
228876|NCT01104701|B3|Baseline|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
228877|NCT01104701|B2|Baseline|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
228878|NCT01104701|B1|Baseline|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
228879|NCT01104701|P4|Participant Flow|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228880|NCT01104701|P3|Participant Flow|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228881|NCT01104701|P2|Participant Flow|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228882|NCT01104701|P1|Participant Flow|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228883|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228884|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228885|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228886|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228887|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228888|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228889|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228890|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228891|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228892|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228893|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228894|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228895|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228896|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228897|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228898|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228899|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228900|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228901|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228902|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228903|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228904|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228905|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228906|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228999|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229000|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
228907|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228908|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228909|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228910|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228911|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228912|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228913|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228914|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228915|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228916|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228917|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228918|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228919|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228920|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228921|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228922|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228923|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228924|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228925|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228926|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228927|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228928|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
228929|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
228930|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
228931|NCT01104701|E4|Reported Event|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
228932|NCT01104701|E3|Reported Event|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
228933|NCT01104701|E2|Reported Event|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
228934|NCT01104701|E1|Reported Event|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
228935|NCT01104662|B9|Baseline|Total|Total of all reporting groups
228936|NCT01104662|B8|Baseline|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228937|NCT01104662|B7|Baseline|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228938|NCT01104662|B6|Baseline|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228939|NCT01104662|B5|Baseline|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228940|NCT01104662|B4|Baseline|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228941|NCT01104662|B3|Baseline|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228942|NCT01104662|B2|Baseline|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228943|NCT01104662|B1|Baseline|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228944|NCT01104662|P8|Participant Flow|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228945|NCT01104662|P7|Participant Flow|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228946|NCT01104662|P6|Participant Flow|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228947|NCT01104662|P5|Participant Flow|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228959|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
229001|NCT01104584|O1|Outcome|CMRM vs UMRM|
228948|NCT01104662|P4|Participant Flow|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228949|NCT01104662|P3|Participant Flow|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228950|NCT01104662|P2|Participant Flow|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228951|NCT01104662|P1|Participant Flow|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228952|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228953|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228954|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228955|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228956|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228957|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
228958|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228960|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228961|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228962|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228963|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228964|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228965|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228966|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228967|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228968|NCT01104662|E8|Reported Event|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228969|NCT01104662|E7|Reported Event|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228970|NCT01104662|E6|Reported Event|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228988|NCT01104584|O1|Outcome|CMRM Versus UMRM|
228971|NCT01104662|E5|Reported Event|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
228972|NCT01104662|E4|Reported Event|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228973|NCT01104662|E3|Reported Event|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
228974|NCT01104662|E2|Reported Event|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
228975|NCT01104662|E1|Reported Event|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
228976|NCT01104636|B1|Baseline|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
228977|NCT01104636|P1|Participant Flow|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
228978|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
228979|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
228980|NCT01104636|E1|Reported Event|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
228981|NCT01104584|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
228982|NCT01104584|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
228983|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
228984|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
228985|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
228986|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
228987|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229002|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229003|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229004|NCT01104584|O1|Outcome|CMRM vs UMRM|
229005|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229006|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229007|NCT01104584|O1|Outcome|CMRM vs UMRM|
229008|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229009|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229010|NCT01104584|O1|Outcome|CMRM vs UMRM|
229011|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229012|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229013|NCT01104584|O1|Outcome|CMRM vs UMRM|
229014|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229015|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229016|NCT01104584|O1|Outcome|CMRM vs UMRM|
229017|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229018|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229019|NCT01104584|O1|Outcome|CMRM vs UMRM|
229020|NCT01104584|O5|Outcome|CMRM+XRM|
229021|NCT01104584|O4|Outcome|UMRM+XRM|
229022|NCT01104584|O3|Outcome|X-ray Mammography (XRM)|
229023|NCT01104584|O2|Outcome|CMRM|
229024|NCT01104584|O1|Outcome|UMRM|
229025|NCT01104584|O4|Outcome|UMRM+XRM|
229026|NCT01104584|O3|Outcome|CMRM+XRM|
229027|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
229028|NCT01104584|O1|Outcome|UMRM|
229029|NCT01104584|O4|Outcome|UMRM+XRM|
229030|NCT01104584|O3|Outcome|CMRM+XRM|
229031|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
229032|NCT01104584|O1|Outcome|UMRM|
229033|NCT01104584|O3|Outcome|UMRM+XRM|
229034|NCT01104584|O2|Outcome|CMRM+XRM|
229035|NCT01104584|O1|Outcome|X-ray Mammography (XRM)|
229036|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
229037|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
229038|NCT01104584|O1|Outcome|CMRM Versus UMRM|
229039|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
229040|NCT01104584|O2|Outcome|CMRM vs XRM|
229041|NCT01104584|O1|Outcome|CMRM Versus UMRM|
229042|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
229043|NCT01104584|O2|Outcome|CMRM vs XRM|
229044|NCT01104584|O1|Outcome|CMRM Versus UMRM|
229045|NCT01104584|O1|Outcome|CMRM|
229046|NCT01104584|O1|Outcome|CMRM|
229047|NCT01104584|O2|Outcome|UMRM|
229048|NCT01104584|O1|Outcome|CMRM|
229049|NCT01104584|O1|Outcome|CMRM Versus UMRM|
229050|NCT01104584|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
229051|NCT01104558|B1|Baseline|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229052|NCT01104558|P1|Participant Flow|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229053|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229054|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229055|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229056|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229057|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229058|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229059|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229060|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229061|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229062|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229063|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229064|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229065|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229066|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229067|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229068|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229069|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229070|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229071|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229072|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229073|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229074|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229075|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229076|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229077|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229147|NCT01104116|B1|Baseline|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
229078|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229079|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229080|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229081|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229082|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229083|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229084|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229085|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229086|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229087|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229088|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229089|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229090|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229091|NCT01104558|E1|Reported Event|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
229092|NCT01104493|B3|Baseline|Total|Total of all reporting groups
229093|NCT01104493|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229094|NCT01104493|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229095|NCT01104493|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229096|NCT01104493|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229097|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229272|NCT01103414|B2|Baseline|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229098|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229099|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229100|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229101|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229102|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229103|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229104|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229105|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229106|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229107|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229108|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229109|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229110|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229111|NCT01104493|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
229112|NCT01104493|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
229113|NCT01104376|B1|Baseline|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
229114|NCT01104376|P1|Participant Flow|CYP2B6 Activity|"CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole.~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
229115|NCT01104376|O1|Outcome|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
229146|NCT01104155|E1|Reported Event|Eribulin Mesylate, 21 Day Cycle|eribulin mesylate + erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
229273|NCT01103414|B1|Baseline|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229116|NCT01104376|E1|Reported Event|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
229117|NCT01104285|B3|Baseline|Total|Total of all reporting groups
229118|NCT01104285|B2|Baseline|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
229119|NCT01104285|B1|Baseline|Standard Care|Treatment of pleural effusion with diuresis
229120|NCT01104285|P2|Participant Flow|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
229121|NCT01104285|P1|Participant Flow|Standard Care|Treatment of pleural effusion with diuresis
229122|NCT01104285|O2|Outcome|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
229123|NCT01104285|O1|Outcome|Standard Care|Treatment of pleural effusion with diuresis
229124|NCT01104285|E2|Reported Event|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
229125|NCT01104285|E1|Reported Event|Standard Care|Treatment of pleural effusion with diuresis
229126|NCT01104246|B1|Baseline|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
229127|NCT01104246|P1|Participant Flow|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
229128|NCT01104246|O1|Outcome|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
229129|NCT01104246|E1|Reported Event|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
229130|NCT01104155|B3|Baseline|Total|Total of all reporting groups
229131|NCT01104155|B2|Baseline|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229132|NCT01104155|B1|Baseline|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229133|NCT01104155|P2|Participant Flow|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229134|NCT01104155|P1|Participant Flow|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229135|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229136|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229137|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229138|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229139|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229140|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229141|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229142|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229143|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
229144|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
229145|NCT01104155|E2|Reported Event|Eribulin Mesylate, 28 Day Cycle|eribulin mesylate + erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
229148|NCT01104116|P1|Participant Flow|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
229149|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
229150|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
229151|NCT01104116|E1|Reported Event|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
229152|NCT01104103|B3|Baseline|Total|Total of all reporting groups
229153|NCT01104103|B2|Baseline|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
229154|NCT01104103|B1|Baseline|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
229155|NCT01104103|P2|Participant Flow|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
229156|NCT01104103|P1|Participant Flow|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
229157|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
229158|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
229159|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
229160|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
229161|NCT01104103|E2|Reported Event|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
229162|NCT01104103|E1|Reported Event|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
229163|NCT01103973|B3|Baseline|Total|Total of all reporting groups
229164|NCT01103973|B2|Baseline|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
229165|NCT01103973|B1|Baseline|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
229166|NCT01103973|P2|Participant Flow|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
229167|NCT01103973|P1|Participant Flow|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
229168|NCT01103973|O2|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
229169|NCT01103973|O1|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
229170|NCT01103973|E2|Reported Event|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
229171|NCT01103973|E1|Reported Event|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
229172|NCT01103960|B3|Baseline|Total|Total of all reporting groups
229173|NCT01103960|B2|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229174|NCT01103960|B1|Baseline|A5 Alone|Amlodipine 5mg monotherapy
229175|NCT01103960|P2|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229176|NCT01103960|P1|Participant Flow|A5 Alone|Amlodipine 5mg monotherapy
229177|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229178|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229179|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229180|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229181|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229182|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229183|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229184|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229185|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229186|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229187|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229188|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229189|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229190|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229191|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229192|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229193|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229194|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229195|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
229196|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
229197|NCT01103960|E2|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
229198|NCT01103960|E1|Reported Event|A5 Alone|Amlodipine 5 mg one daily
229199|NCT01103934|B3|Baseline|Total|Total of all reporting groups
229200|NCT01103934|B2|Baseline|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229274|NCT01103414|P5|Participant Flow|Matching Placebo|Over-encapsulated placebo tablet
229812|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229201|NCT01103934|B1|Baseline|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229202|NCT01103934|P2|Participant Flow|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229203|NCT01103934|P1|Participant Flow|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229204|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229205|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229206|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229207|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229208|NCT01103934|E2|Reported Event|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229209|NCT01103934|E1|Reported Event|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
229210|NCT01103713|B1|Baseline|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
229211|NCT01103713|P1|Participant Flow|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
229212|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229213|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229214|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229215|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229216|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229217|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229218|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229219|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229220|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229221|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229222|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229223|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229275|NCT01103414|P4|Participant Flow|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229276|NCT01103414|P3|Participant Flow|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229224|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229225|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229226|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229227|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229228|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229229|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229230|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
229231|NCT01103713|O1|Outcome|Azithromycin/Chloroquine (AZCQ)|This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
229232|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
229233|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
229234|NCT01103713|E2|Reported Event|Azithromycin/Chloroquine (Familial Status = Mother)|ACZQ (Familial Status = Mother)
229235|NCT01103713|E1|Reported Event|Azithromycin/Chloroquine (Familial Status = Neonate)|AZCQ (Familial Status = Neonate)
229236|NCT01103492|B1|Baseline|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
229237|NCT01103492|P1|Participant Flow|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
229238|NCT01103492|O1|Outcome|Ablation Treatment|Subjects with radiation proctitis who met inclusion criteria
229239|NCT01103492|E1|Reported Event|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
229240|NCT01103479|B4|Baseline|Total|Total of all reporting groups
229241|NCT01103479|B3|Baseline|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
229242|NCT01103479|B2|Baseline|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
229243|NCT01103479|B1|Baseline|Control|Participants will complete interviewer-administered pre- and post-test
229244|NCT01103479|P3|Participant Flow|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
229245|NCT01103479|P2|Participant Flow|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
229246|NCT01103479|P1|Participant Flow|Control|Participants will complete interviewer-administered pre- and post-test
229247|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
229248|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
229249|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
229250|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
229251|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
229252|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
229253|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
229254|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
229255|NCT01103479|E3|Reported Event|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
229256|NCT01103479|E2|Reported Event|Physician Training|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
229257|NCT01103479|E1|Reported Event|Control|Participants will complete interviewer-administered pre- and post-test
229258|NCT01103466|B1|Baseline|All Study Parcipitants|All parcipitants recieved all three intervention and they are therefore combined into one group.
229259|NCT01103466|P3|Participant Flow|Conform2|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
229260|NCT01103466|P2|Participant Flow|SenSura|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
229261|NCT01103466|P1|Participant Flow|Atlas|"New base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
229262|NCT01103466|O3|Outcome|Conform2|base plate
229263|NCT01103466|O2|Outcome|SenSura|base plate
229264|NCT01103466|O1|Outcome|Atlas|new base plate
229265|NCT01103466|E3|Reported Event|Conform2|base plate
229266|NCT01103466|E2|Reported Event|SenSura|base plate
229267|NCT01103466|E1|Reported Event|Atlas|new base plate
229268|NCT01103414|B6|Baseline|Total|Total of all reporting groups
229269|NCT01103414|B5|Baseline|Matching Placebo|Over-encapsulated placebo tablet
229270|NCT01103414|B4|Baseline|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229271|NCT01103414|B3|Baseline|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229277|NCT01103414|P2|Participant Flow|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229278|NCT01103414|P1|Participant Flow|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229279|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229280|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229281|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229282|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229283|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229284|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229285|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229286|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229287|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229288|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229289|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229290|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229291|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229292|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229293|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229294|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229295|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229296|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229297|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229298|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229299|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229300|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229301|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229302|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229303|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229304|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229305|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229306|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229307|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229308|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229309|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229310|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229311|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229312|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229313|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229314|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229315|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229316|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229317|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229318|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229319|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229320|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229321|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229322|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229323|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229324|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229325|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229326|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229327|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229328|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229329|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
229330|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229331|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229332|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229333|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229334|NCT01103414|E5|Reported Event|Matching Placebo|Over-encapsulated placebo tablet
229335|NCT01103414|E4|Reported Event|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
229336|NCT01103414|E3|Reported Event|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
229337|NCT01103414|E2|Reported Event|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
229338|NCT01103414|E1|Reported Event|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
229339|NCT01103362|B1|Baseline|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
229340|NCT01103362|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
229341|NCT01103362|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
229342|NCT01103362|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
229343|NCT01103323|B3|Baseline|Total|Total of all reporting groups
229344|NCT01103323|B2|Baseline|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229345|NCT01103323|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229346|NCT01103323|P2|Participant Flow|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.
229347|NCT01103323|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229348|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
229349|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229350|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
229351|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229352|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
229353|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229354|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
229355|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229356|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
229357|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229358|NCT01103323|E3|Reported Event|Placebo - Regorafenib After Unblinding|Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only
229359|NCT01103323|E2|Reported Event|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.
229360|NCT01103323|E1|Reported Event|Regorafenib (BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
229361|NCT01103284|B3|Baseline|Total|Total of all reporting groups
229362|NCT01103284|B2|Baseline|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229363|NCT01103284|B1|Baseline|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229364|NCT01103284|P2|Participant Flow|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229365|NCT01103284|P1|Participant Flow|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229366|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229367|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229368|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229369|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229370|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229371|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229372|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229373|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229374|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229375|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229376|NCT01103284|E2|Reported Event|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
229377|NCT01103284|E1|Reported Event|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
229378|NCT01103271|B3|Baseline|Total|Total of all reporting groups
229379|NCT01103271|B2|Baseline|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
229380|NCT01103271|B1|Baseline|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
229381|NCT01103271|P2|Participant Flow|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
229382|NCT01103271|P1|Participant Flow|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
229383|NCT01103271|O2|Outcome|Placebo Comparator: Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
229384|NCT01103271|O1|Outcome|Open Label-Placebo: Immediate Treatment|Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
229385|NCT01103271|O1|Outcome|Placebo Effect Study|These were all participants who were screened for the study but not yet enrolled.
229386|NCT01103271|E2|Reported Event|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
229387|NCT01103271|E1|Reported Event|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
229388|NCT01103232|B3|Baseline|Total|Total of all reporting groups
229389|NCT01103232|B2|Baseline|Control|Transcutaneous electrical nerve stimulation was applied
229390|NCT01103232|B1|Baseline|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
229391|NCT01103232|P2|Participant Flow|Control|Transcutaneous electrical nerve stimulation was applied
229392|NCT01103232|P1|Participant Flow|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
229393|NCT01103232|O2|Outcome|Control|Transcutaneous electrical nerve stimulation was applied
229394|NCT01103232|O1|Outcome|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
229395|NCT01103232|E2|Reported Event|Control|Transcutaneous electrical nerve stimulation was applied
229396|NCT01103232|E1|Reported Event|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
229397|NCT01103063|B3|Baseline|Total|Total of all reporting groups
229398|NCT01103063|B2|Baseline|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229399|NCT01103063|B1|Baseline|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229400|NCT01103063|P2|Participant Flow|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229401|NCT01103063|P1|Participant Flow|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229402|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229403|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229404|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229405|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229540|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
229406|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229407|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229408|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229409|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229410|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229411|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229412|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229413|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229414|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229415|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229416|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229417|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229418|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229419|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229420|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229421|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229422|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229423|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229424|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229425|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229426|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229471|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229427|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229428|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229429|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229430|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229431|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229432|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229433|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229434|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229435|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229436|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229437|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229438|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229439|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229440|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229441|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229442|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229443|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229444|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229445|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229446|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229447|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229472|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229448|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229449|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229450|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229451|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229452|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229453|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229454|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229455|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229456|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229457|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229458|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229459|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229460|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229461|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229462|NCT01103063|E4|Reported Event|Neonate (Sulfadoxine + Pyrimethamine)|Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229463|NCT01103063|E3|Reported Event|Neonate (Azithromycin + Chloroquine)|Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229464|NCT01103063|E2|Reported Event|Mother (Sulfadoxine + Pyrimethamine)|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
229465|NCT01103063|E1|Reported Event|Mother (Azithromycin + Chloroquine)|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
229466|NCT01102972|B3|Baseline|Total|Total of all reporting groups
229467|NCT01102972|B2|Baseline|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229468|NCT01102972|B1|Baseline|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229469|NCT01102972|P2|Participant Flow|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229470|NCT01102972|P1|Participant Flow|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229538|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
229473|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229474|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229475|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229476|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229477|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229478|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229479|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229480|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229481|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229482|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229483|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229484|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229485|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229486|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229487|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229488|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229489|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229490|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229491|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229492|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229493|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229494|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229495|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229496|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229497|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229498|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229499|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229500|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229501|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229502|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229539|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
229503|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229504|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229505|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229506|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229507|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229508|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229509|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229510|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229511|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229512|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229513|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229514|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229515|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229516|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229517|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229518|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229519|NCT01102972|E2|Reported Event|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
229520|NCT01102972|E1|Reported Event|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
229521|NCT01102894|B1|Baseline|Low Fiber and High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber~SmartPill : SmartPill"
229522|NCT01102894|P1|Participant Flow|High Fiber and Low Fiber|"Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229523|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229524|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229525|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229526|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229527|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229528|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229529|NCT01102894|E2|Reported Event|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229530|NCT01102894|E1|Reported Event|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
229531|NCT01102803|B3|Baseline|Total|Total of all reporting groups
229532|NCT01102803|B2|Baseline|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
229533|NCT01102803|B1|Baseline|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
229534|NCT01102803|P2|Participant Flow|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
229535|NCT01102803|P1|Participant Flow|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
229536|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
229537|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
229615|NCT01102218|B3|Baseline|Total|Total of all reporting groups
229541|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
229542|NCT01102803|O2|Outcome|Placebo+CBT Treatment|Participants receiving PL augmented CBT
229543|NCT01102803|O1|Outcome|DCS+CBT Treatment|Participants receiving DCS augmented CBT
229544|NCT01102803|E2|Reported Event|Pill Placebo + CBT|CBT augmented with sugar pill placebo
229545|NCT01102803|E1|Reported Event|DCS+CBT|CBT augmented with DCS (50mg)
229546|NCT01102777|B3|Baseline|Total|Total of all reporting groups
229547|NCT01102777|B2|Baseline|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229548|NCT01102777|B1|Baseline|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229549|NCT01102777|P2|Participant Flow|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229550|NCT01102777|P1|Participant Flow|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229551|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229552|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229553|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229554|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229555|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229556|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229557|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229558|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229559|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229560|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229561|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229562|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229563|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229564|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229565|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229566|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229616|NCT01102218|B2|Baseline|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
229567|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229568|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229569|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229570|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229571|NCT01102777|E2|Reported Event|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
229572|NCT01102777|E1|Reported Event|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
229573|NCT01102764|B3|Baseline|Total|Total of all reporting groups
229574|NCT01102764|B2|Baseline|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229575|NCT01102764|B1|Baseline|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229576|NCT01102764|P2|Participant Flow|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229577|NCT01102764|P1|Participant Flow|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229578|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229579|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229580|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229581|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229582|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229583|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229584|NCT01102764|E2|Reported Event|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
229585|NCT01102764|E1|Reported Event|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
229586|NCT01102491|B3|Baseline|Total|Total of all reporting groups
229587|NCT01102491|B2|Baseline|Control|no antiemetic prophylaxis
229588|NCT01102491|B1|Baseline|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
229589|NCT01102491|P2|Participant Flow|Control|no antiemetic prophylaxis
229590|NCT01102491|P1|Participant Flow|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
229591|NCT01102491|O2|Outcome|Control|no antiemetic prophylaxis
229592|NCT01102491|O1|Outcome|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
229593|NCT01102491|E2|Reported Event|Control|no antiemetic prophylaxis
229594|NCT01102491|E1|Reported Event|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
229595|NCT01102413|B3|Baseline|Total|Total of all reporting groups
229596|NCT01102413|B2|Baseline|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
229597|NCT01102413|B1|Baseline|Monofer|"Injections or infusions~Monofer: Infusion or injections"
229598|NCT01102413|P2|Participant Flow|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
229599|NCT01102413|P1|Participant Flow|Monofer|"Injections or infusions~Monofer: Infusion or injections"
229600|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
229601|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
229602|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
229603|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
229604|NCT01102413|E2|Reported Event|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
229605|NCT01102413|E1|Reported Event|Monofer|"Injections or infusions~Monofer: Infusion or injections"
229606|NCT01102257|B3|Baseline|Total|Total of all reporting groups
229607|NCT01102257|B2|Baseline|Olive Oil|5 Gel Capsules of olive oil taken orally daily
229608|NCT01102257|B1|Baseline|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
229609|NCT01102257|P2|Participant Flow|Olive Oil|5 Gel Capsules of olive oil to be taken orally daily
229610|NCT01102257|P1|Participant Flow|Omega-3 Supplement|5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
229611|NCT01102257|O2|Outcome|Olive Oil|5 Gel Capsules of olive oil taken orally daily
229612|NCT01102257|O1|Outcome|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
229613|NCT01102257|E2|Reported Event|Olive Oil|5 Gel Capsules of olive oil taken orally daily
229614|NCT01102257|E1|Reported Event|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
229617|NCT01102218|B1|Baseline|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
229618|NCT01102218|P2|Participant Flow|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
229619|NCT01102218|P1|Participant Flow|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
229620|NCT01102218|O2|Outcome|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
229621|NCT01102218|O1|Outcome|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
229622|NCT01102218|E2|Reported Event|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
229623|NCT01102218|E1|Reported Event|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
229624|NCT01101958|B3|Baseline|Total|Total of all reporting groups
229625|NCT01101958|B2|Baseline|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229626|NCT01101958|B1|Baseline|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229627|NCT01101958|P2|Participant Flow|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229628|NCT01101958|P1|Participant Flow|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229629|NCT01101958|O2|Outcome|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229630|NCT01101958|O1|Outcome|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229631|NCT01101958|E2|Reported Event|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229632|NCT01101958|E1|Reported Event|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
229633|NCT01101867|B3|Baseline|Total|Total of all reporting groups
229634|NCT01101867|B2|Baseline|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
229635|NCT01101867|B1|Baseline|Flexible Dose|aspart dose determined based upon carbohydrate intake.
229636|NCT01101867|P2|Participant Flow|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
229637|NCT01101867|P1|Participant Flow|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
229638|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
229639|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
229640|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
229641|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
229642|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
229643|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
229644|NCT01101867|E2|Reported Event|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
229645|NCT01101867|E1|Reported Event|Flexible Dose|aspart dose determined based upon carbohydrate intake.
229646|NCT01101841|B3|Baseline|Total|Total of all reporting groups
229647|NCT01101841|B2|Baseline|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229648|NCT01101841|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
229649|NCT01101841|P2|Participant Flow|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229650|NCT01101841|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
229651|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229652|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229653|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229654|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229655|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229656|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229657|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229658|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229659|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229660|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229661|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229662|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229663|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229664|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229665|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229666|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229667|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229668|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229669|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229670|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229671|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229672|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229673|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229674|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229675|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229676|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio.
229677|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229678|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229679|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229680|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229681|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229682|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229683|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229684|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229685|NCT01101841|E2|Reported Event|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
229686|NCT01101841|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
229687|NCT01101542|B1|Baseline|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229688|NCT01101542|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229689|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229710|NCT01101477|O3|Outcome|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229924|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
229690|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229691|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229692|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229693|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229694|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229695|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229696|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229697|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229698|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
229699|NCT01101542|E4|Reported Event|Cervarix Year 6 Group|Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229700|NCT01101542|E3|Reported Event|Cervarix Year 5 Group|Subjects enrolled for surveillance Year 5, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229701|NCT01101542|E2|Reported Event|Cervarix Year 4 Group|Subjects enrolled for surveillance Year 4, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229702|NCT01101542|E1|Reported Event|Cervarix Year 3 Group|Subjects enrolled for surveillance Year 3, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
229703|NCT01101477|B4|Baseline|Total|Total of all reporting groups
229704|NCT01101477|B3|Baseline|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229705|NCT01101477|B2|Baseline|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229706|NCT01101477|B1|Baseline|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229707|NCT01101477|P3|Participant Flow|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229708|NCT01101477|P2|Participant Flow|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229709|NCT01101477|P1|Participant Flow|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229925|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
229711|NCT01101477|O2|Outcome|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229712|NCT01101477|O1|Outcome|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229713|NCT01101477|E3|Reported Event|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229714|NCT01101477|E2|Reported Event|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229715|NCT01101477|E1|Reported Event|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
229716|NCT01101464|B3|Baseline|Total|Total of all reporting groups
229717|NCT01101464|B2|Baseline|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
229718|NCT01101464|B1|Baseline|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
229719|NCT01101464|P2|Participant Flow|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
229720|NCT01101464|P1|Participant Flow|Asenapine, (3) 5mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
229721|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
229722|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
229723|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
229724|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
229725|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
229726|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
229727|NCT01101464|E2|Reported Event|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
229728|NCT01101464|E1|Reported Event|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
229729|NCT01101321|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
229730|NCT01101321|P2|Participant Flow|Reformulated OXY (Wilson) (Reference) First|Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
229731|NCT01101321|P1|Participant Flow|Reformulated OXY (Totowa) (Test) First|Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
229732|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229733|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229734|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229735|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229736|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229737|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229738|NCT01101321|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229739|NCT01101321|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229740|NCT01101308|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
229741|NCT01101308|P2|Participant Flow|Reformulated OXY 10 mg (Wilson) (Reference) First|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Wilson) (Reference) in period 1 and reformulated OXY (Totowa) (Test) in period 2.
229774|NCT01101178|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229742|NCT01101308|P1|Participant Flow|Reformulated OXY 10 mg (Totowa) (Test) First|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
229743|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229744|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229745|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229746|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229747|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229748|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229749|NCT01101308|E3|Reported Event|Prerandomization|
229750|NCT01101308|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229751|NCT01101308|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229752|NCT01101191|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
229753|NCT01101191|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229754|NCT01101191|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229755|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229756|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229757|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229758|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229759|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229760|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229761|NCT01101191|E3|Reported Event|Prerandomization|
229762|NCT01101191|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229763|NCT01101191|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229764|NCT01101178|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
229765|NCT01101178|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
229766|NCT01101178|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
229767|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
229768|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229769|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
229770|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229771|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
229772|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229773|NCT01101178|E3|Reported Event|Screening|
229775|NCT01101178|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
229776|NCT01101165|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
229777|NCT01101165|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
229778|NCT01101165|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
229779|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229780|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229781|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229782|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229783|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229784|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229785|NCT01101165|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229786|NCT01101165|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
229787|NCT01101022|B3|Baseline|Total|Total of all reporting groups
229788|NCT01101022|B2|Baseline|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229789|NCT01101022|B1|Baseline|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229790|NCT01101022|P2|Participant Flow|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229791|NCT01101022|P1|Participant Flow|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229792|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229793|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229794|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229795|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229796|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229797|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229798|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229799|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229800|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229801|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229802|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229803|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229804|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229805|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229806|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229807|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229808|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229809|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229810|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229811|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229813|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229814|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229815|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229816|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229817|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229818|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229819|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229820|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229821|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229822|NCT01101022|E2|Reported Event|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
229823|NCT01101022|E1|Reported Event|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
229824|NCT01100944|B1|Baseline|All Participants|All participants who had at least one dose of Belinostat.
229825|NCT01100944|P3|Participant Flow|Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD)|Patients were treated with belinostat, doxorubicin, cisplatin and cyclophosphamide at the maximum tolerated dose derived from the phase I dose level.
229826|NCT01100944|P2|Participant Flow|Belinostat 500mg/m(2) and Chemotherapy|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229827|NCT01100944|P1|Participant Flow|Belinostat 250mg/m(2) and Chemotherapy|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229828|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229829|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229830|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229831|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229893|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229894|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229832|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229833|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229834|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229835|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229836|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229837|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229838|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229839|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229840|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229841|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229842|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229843|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229844|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229845|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229846|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229847|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229848|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229849|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229895|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229896|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229897|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229850|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229851|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229852|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229853|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229854|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229855|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229856|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229857|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229898|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229899|NCT01100853|E2|Reported Event|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229858|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229859|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229860|NCT01100944|O1|Outcome|Thymic Particpants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229861|NCT01100944|O3|Outcome|All Participants|All participants who had at least one dose of belinostat.
229862|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229863|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD) and was utilized in the expansion phase (phase 2)."
229864|NCT01100944|O1|Outcome|All Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229865|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
229866|NCT01100944|O2|Outcome|Thymoma Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
229867|NCT01100944|O1|Outcome|Thymic Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
229900|NCT01100853|E1|Reported Event|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229868|NCT01100944|O1|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229869|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
229870|NCT01100944|E1|Reported Event|All Participants|All participants who had at least one dose of belinostat.
229871|NCT01100931|B3|Baseline|Total|Total of all reporting groups
229872|NCT01100931|B2|Baseline|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
229873|NCT01100931|B1|Baseline|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
229874|NCT01100931|P2|Participant Flow|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
229875|NCT01100931|P1|Participant Flow|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
229876|NCT01100931|O2|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
229877|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
229878|NCT01100931|O1|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
229879|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
229880|NCT01100931|E2|Reported Event|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
229881|NCT01100931|E1|Reported Event|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
229882|NCT01100853|B3|Baseline|Total|Total of all reporting groups
229883|NCT01100853|B2|Baseline|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229884|NCT01100853|B1|Baseline|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229885|NCT01100853|P2|Participant Flow|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229886|NCT01100853|P1|Participant Flow|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229887|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229888|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229889|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229890|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229891|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229892|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
229901|NCT01100762|B1|Baseline|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
229902|NCT01100762|P1|Participant Flow|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
229903|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229904|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229905|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229906|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229907|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229908|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229909|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229910|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229911|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229912|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229913|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229914|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229915|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229916|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229917|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229918|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
229919|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
229920|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
229921|NCT01100762|E1|Reported Event|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
229922|NCT01100723|B1|Baseline|Post Treatment|Results analyzed at study evaluation time points.
229923|NCT01100723|P1|Participant Flow|Post Treatment|Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
229926|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
229927|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
229928|NCT01100723|O1|Outcome|Results Analyzed at Study Evaluation Time Points.|Results analyzed at study evaluation time points of 1 year and 6 months.
229929|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
229930|NCT01100723|E1|Reported Event|Post Treatment|Results analyzed at study evaluation time points.
229931|NCT01100658|B1|Baseline|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
229932|NCT01100658|P1|Participant Flow|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
229933|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
229934|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
229935|NCT01100658|E1|Reported Event|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
229936|NCT01100606|B1|Baseline|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
229937|NCT01100606|P2|Participant Flow|EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
229938|NCT01100606|P1|Participant Flow|EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
229939|NCT01100606|O1|Outcome|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
229940|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229941|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229942|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229943|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229944|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229945|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229946|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229947|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229948|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229949|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229950|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229951|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229952|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229953|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229954|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229955|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229956|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229957|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229958|NCT01100606|E3|Reported Event|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229959|NCT01100606|E2|Reported Event|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
229960|NCT01100606|E1|Reported Event|Zenpep®|Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
229961|NCT01100502|B3|Baseline|Total|Total of all reporting groups
229962|NCT01100502|B2|Baseline|Placebo|placebo every 3 weeks by IV infusion
229963|NCT01100502|B1|Baseline|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229964|NCT01100502|P2|Participant Flow|Placebo|placebo every 3 weeks by IV infusion
229965|NCT01100502|P1|Participant Flow|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229966|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
229967|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229968|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
229969|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229970|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
229971|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229972|NCT01100502|E2|Reported Event|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
229973|NCT01100502|E1|Reported Event|Placebo|placebo every 3 weeks by IV infusion
229974|NCT01100437|B1|Baseline|Entire Study Population|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant’s pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups.
229975|NCT01100437|P3|Participant Flow|EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant’s were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase.
229976|NCT01100437|P2|Participant Flow|EMBEDA Solution Then EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant’s stable dose along with matched placebo solution.
230003|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229977|NCT01100437|P1|Participant Flow|EMBEDA Capsule Then EMBEDA Solution|EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant’s stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules.
229978|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229979|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229980|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229981|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229982|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229983|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229984|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229985|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229986|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229987|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229988|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229989|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229990|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229991|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229992|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229993|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229994|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229995|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229996|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229997|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
229998|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
229999|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230000|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
230001|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230002|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
230004|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
230005|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230006|NCT01100437|O1|Outcome|EMBEDA Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230007|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
230008|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230009|NCT01100437|E4|Reported Event|EMBEDA Capsules Maintenance Period|EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum.
230010|NCT01100437|E3|Reported Event|EMBEDA Capsule Titration/Stabilization Period|EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain.
230011|NCT01100437|E2|Reported Event|EMBEDA Crushed in Solution Treatment Period|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period .
230012|NCT01100437|E1|Reported Event|EMBEDA Whole Capsule Treatment Period|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
230013|NCT01100320|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
230014|NCT01100320|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
230015|NCT01100320|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
230016|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230017|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230018|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230019|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230020|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230021|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230022|NCT01100320|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230023|NCT01100320|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230024|NCT01100307|B3|Baseline|Total|Total of all reporting groups
230025|NCT01100307|B2|Baseline|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230026|NCT01100307|B1|Baseline|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230027|NCT01100307|P2|Participant Flow|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230028|NCT01100307|P1|Participant Flow|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230029|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230134|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230030|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230031|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230032|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230033|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230034|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230035|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230036|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230037|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230038|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230039|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230040|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230041|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230042|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230043|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230044|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230045|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230046|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230047|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230048|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230049|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230050|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230051|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230052|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230053|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230054|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230055|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230056|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230057|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230058|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230059|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230060|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230061|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230062|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230063|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230064|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230065|NCT01100307|E4|Reported Event|Sham Conversion (Week 24 to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
230135|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230066|NCT01100307|E3|Reported Event|Pegaptanib Sodium (Baseline to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
230067|NCT01100307|E2|Reported Event|Sham (Baseline to Week 24)|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication.
230068|NCT01100307|E1|Reported Event|Pegaptanib Sodium (Baseline to Week 24)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24).
230069|NCT01100268|B1|Baseline|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
230070|NCT01100268|P1|Participant Flow|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
230071|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
230072|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
230073|NCT01100268|E1|Reported Event|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
230074|NCT01100255|B3|Baseline|Total|Total of all reporting groups
230075|NCT01100255|B2|Baseline|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
230076|NCT01100255|B1|Baseline|Group A|v0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
230077|NCT01100255|P2|Participant Flow|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
230078|NCT01100255|P1|Participant Flow|Group A|0.5mg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
230079|NCT01100255|O2|Outcome|Ketamine Infusion|"0.5mg/kg IV infusion over 40 minutes~Ketamine infusion: 0.5mg/kg IV over 40 minutes"
230080|NCT01100255|O1|Outcome|Saline Infusion|"IV saline infusion over 40 minutes~Saline: saline infusion"
230081|NCT01100255|E2|Reported Event|Ketamine Infusion|0.5mg/kg IV ketamine infusion over 40 minutes
230082|NCT01100255|E1|Reported Event|Saline Infusion|IV saline infusion over 40 minutes
230083|NCT01100242|B1|Baseline|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
230084|NCT01100242|P1|Participant Flow|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
230085|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
230086|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
230087|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
230088|NCT01100242|E1|Reported Event|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
230089|NCT01100112|B1|Baseline|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230090|NCT01100112|P1|Participant Flow|Budesonide|"Budesonide-multi-matrix system (MMX) 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230091|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230092|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230093|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230094|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230095|NCT01100112|E1|Reported Event|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
230096|NCT01100086|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
230097|NCT01100086|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
230098|NCT01100086|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
230099|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230100|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230101|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230102|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230103|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230104|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230105|NCT01100086|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230106|NCT01100086|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
230107|NCT01100073|B1|Baseline|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230108|NCT01100073|P1|Participant Flow|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230109|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230110|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230111|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230112|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230113|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230114|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230115|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230116|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230117|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230118|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230119|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230120|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230121|NCT01100073|E1|Reported Event|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
230122|NCT01099917|B1|Baseline|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
230123|NCT01099917|P1|Participant Flow|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
230124|NCT01099917|O1|Outcome|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
230125|NCT01099917|E1|Reported Event|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
230126|NCT01099774|B3|Baseline|Total|Total of all reporting groups
230127|NCT01099774|B2|Baseline|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230128|NCT01099774|B1|Baseline|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230129|NCT01099774|P2|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230130|NCT01099774|P1|Participant Flow|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230131|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230132|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230133|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230136|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230137|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230138|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230139|NCT01099774|E2|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
230140|NCT01099774|E1|Reported Event|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
230141|NCT01099761|B5|Baseline|Total|Total of all reporting groups
230142|NCT01099761|B4|Baseline|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230143|NCT01099761|B3|Baseline|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230144|NCT01099761|B2|Baseline|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230145|NCT01099761|B1|Baseline|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230146|NCT01099761|P4|Participant Flow|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230147|NCT01099761|P3|Participant Flow|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230148|NCT01099761|P2|Participant Flow|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230149|NCT01099761|P1|Participant Flow|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230150|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230151|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230152|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230153|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230154|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230155|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230156|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230157|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230158|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230159|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230160|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230161|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230162|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230163|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230164|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230165|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230166|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230167|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230168|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230169|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230170|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230171|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230172|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230173|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230174|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230175|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230176|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230177|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230178|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230179|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230180|NCT01099761|E4|Reported Event|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
230181|NCT01099761|E3|Reported Event|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230182|NCT01099761|E2|Reported Event|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
230183|NCT01099761|E1|Reported Event|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
230184|NCT01099709|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
230185|NCT01099709|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
230186|NCT01099709|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
230187|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230188|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dosed administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230189|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230190|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230191|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230192|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
230193|NCT01099709|E2|Reported Event|Original OxyContin® (OXY) 10-mg Tablet (Fed)|Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
230194|NCT01099709|E1|Reported Event|Reformulated OXY 10-mg Tablet (Fed)|Reformulated OXY 10-mg tablet (fed) x 1 dose
230195|NCT01099618|B4|Baseline|Total|Total of all reporting groups
230196|NCT01099618|B3|Baseline|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230197|NCT01099618|B2|Baseline|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230198|NCT01099618|B1|Baseline|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230199|NCT01099618|P3|Participant Flow|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230200|NCT01099618|P2|Participant Flow|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230201|NCT01099618|P1|Participant Flow|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230202|NCT01099618|O3|Outcome|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230203|NCT01099618|O2|Outcome|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230204|NCT01099618|O1|Outcome|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230205|NCT01099618|E3|Reported Event|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230206|NCT01099618|E2|Reported Event|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230207|NCT01099618|E1|Reported Event|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
230208|NCT01099579|B4|Baseline|Total|Total of all reporting groups
230209|NCT01099579|B3|Baseline|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230210|NCT01099579|B2|Baseline|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230211|NCT01099579|B1|Baseline|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230212|NCT01099579|P3|Participant Flow|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
230213|NCT01099579|P2|Participant Flow|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
230214|NCT01099579|P1|Participant Flow|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
230215|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230216|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230217|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230218|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230219|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230220|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230221|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230222|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230223|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230224|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230225|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230226|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230227|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230228|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230229|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230230|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
230231|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
230232|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
230233|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
230234|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230235|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230236|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230237|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
230238|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
230239|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230240|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230241|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230242|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230243|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230244|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230245|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230246|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230247|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230248|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230249|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230250|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230251|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
230252|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
230253|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230254|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230255|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230256|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
230257|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
230258|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230362|NCT01099202|O1|Outcome|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
230363|NCT01099202|O2|Outcome|No Procrit|No intervention.
230364|NCT01099202|O1|Outcome|Procrit|Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.
230259|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230260|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230261|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230262|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
230263|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
230264|NCT01099579|E3|Reported Event|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230265|NCT01099579|E2|Reported Event|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230266|NCT01099579|E1|Reported Event|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
230267|NCT01099475|B3|Baseline|Total|Total of all reporting groups
230268|NCT01099475|B2|Baseline|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230269|NCT01099475|B1|Baseline|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230365|NCT01099202|E2|Reported Event|No Procrit|No intervention.
230583|NCT01098318|B2|Baseline|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
230270|NCT01099475|P2|Participant Flow|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230271|NCT01099475|P1|Participant Flow|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230272|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230273|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230274|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230275|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230276|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230277|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230278|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230279|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230280|NCT01099475|E2|Reported Event|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
230281|NCT01099475|E1|Reported Event|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
230282|NCT01099397|B1|Baseline|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
230283|NCT01099397|P1|Participant Flow|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
230284|NCT01099397|O2|Outcome|Fasting Glucose|Fasting glucose collected
230285|NCT01099397|O1|Outcome|2-hour Glucose|Glucose collected after a 2 hour oral glucose tolerance test
230286|NCT01099397|E1|Reported Event|PEAR Sub-study Participants|All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study
230310|NCT01099267|P1|Participant Flow|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230366|NCT01099202|E1|Reported Event|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
230367|NCT01099111|B6|Baseline|Total|Total of all reporting groups
230287|NCT01099358|B1|Baseline|All Participants (All Participants (Group A, B, C and D)|"A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.~400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.~B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.~250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1.~D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1."
230288|NCT01099358|P4|Participant Flow|Cetuximab and Cisplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230289|NCT01099358|P3|Participant Flow|Cetuximab and Cisplatin (C)|"Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230290|NCT01099358|P2|Participant Flow|Cetuximab on Cisplatin (B)|"Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230291|NCT01099358|P1|Participant Flow|Cisplatin on Cetuximab (A)|"Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230292|NCT01099358|O1|Outcome|Cetuximab (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1."
230293|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230294|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230349|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230350|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230351|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230352|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230353|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230295|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230296|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230297|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230298|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230299|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230300|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230301|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230354|NCT01099215|E2|Reported Event|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230355|NCT01099215|E1|Reported Event|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230356|NCT01099202|B3|Baseline|Total|Total of all reporting groups
230357|NCT01099202|B2|Baseline|No Procrit|No intervention.
230358|NCT01099202|B1|Baseline|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
230302|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230303|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230304|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
230305|NCT01099358|E4|Reported Event|Cetuximab and Cisplatin (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230306|NCT01099358|E3|Reported Event|Cetuximab and Cisplatin (C)|"Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230307|NCT01099358|E2|Reported Event|Cetuximab on Cisplatin (B)|"Cetuximab on Cisplatin (B)~Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230308|NCT01099358|E1|Reported Event|Cisplatin on Cetuximab (A)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
230309|NCT01099267|B1|Baseline|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230359|NCT01099202|P2|Participant Flow|No Procrit|No intervention.
230360|NCT01099202|P1|Participant Flow|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
230361|NCT01099202|O2|Outcome|No Procrit|No intervention.
230311|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230312|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230313|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230314|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230315|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230316|NCT01099267|E1|Reported Event|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
230317|NCT01099215|B3|Baseline|Total|Total of all reporting groups
230318|NCT01099215|B2|Baseline|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230319|NCT01099215|B1|Baseline|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230320|NCT01099215|P2|Participant Flow|High Dose PVS-10200 (Cohort B)|High dose PVS-10200 (15×10^5 cells/cm lesion)
230321|NCT01099215|P1|Participant Flow|Low Dose PVS-10200 (Cohort A)|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230322|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230323|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230324|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230325|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230326|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230327|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230328|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230329|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230330|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230331|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230332|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230333|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230334|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230335|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230336|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230337|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230338|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230339|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230340|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230341|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230342|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230343|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230344|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230345|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230346|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230347|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
230348|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
230368|NCT01099111|B5|Baseline|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230369|NCT01099111|B4|Baseline|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230370|NCT01099111|B3|Baseline|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230371|NCT01099111|B2|Baseline|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230372|NCT01099111|B1|Baseline|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230373|NCT01099111|P5|Participant Flow|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230374|NCT01099111|P4|Participant Flow|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230375|NCT01099111|P3|Participant Flow|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230421|NCT01098747|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230422|NCT01098747|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets.
230423|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230584|NCT01098318|B1|Baseline|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
230376|NCT01099111|P2|Participant Flow|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230377|NCT01099111|P1|Participant Flow|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230378|NCT01099111|O5|Outcome|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230379|NCT01099111|O4|Outcome|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230380|NCT01099111|O3|Outcome|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230381|NCT01099111|O2|Outcome|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230382|NCT01099111|O1|Outcome|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230383|NCT01099111|E5|Reported Event|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230424|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230425|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230426|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230384|NCT01099111|E4|Reported Event|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230385|NCT01099111|E3|Reported Event|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230386|NCT01099111|E2|Reported Event|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230387|NCT01099111|E1|Reported Event|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
230388|NCT01098851|B3|Baseline|Total|Total of all reporting groups
230389|NCT01098851|B2|Baseline|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
230390|NCT01098851|B1|Baseline|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
230391|NCT01098851|P2|Participant Flow|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
230392|NCT01098851|P1|Participant Flow|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
230393|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
230394|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
230395|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
230396|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
230397|NCT01098851|E2|Reported Event|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
230398|NCT01098851|E1|Reported Event|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
230399|NCT01098812|B4|Baseline|Total|Total of all reporting groups
230400|NCT01098812|B3|Baseline|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
230401|NCT01098812|B2|Baseline|Toric IOL|Investigational Toric IOL
230402|NCT01098812|B1|Baseline|ZCB00|Approved Intraocular control lens
230403|NCT01098812|P3|Participant Flow|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
230404|NCT01098812|P2|Participant Flow|Toric IOL|Investigational Toric IOL
230405|NCT01098812|P1|Participant Flow|ZCB00|Approved Intraocular control lens
230406|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
230407|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
230408|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
230409|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
230410|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
230411|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
230412|NCT01098812|E2|Reported Event|All Toric IOLs|Investigational Toric IOLs including high cylinder powers
230413|NCT01098812|E1|Reported Event|ZCB00|Approved Intraocular control lens
230414|NCT01098747|B5|Baseline|Total|Total of all reporting groups
230415|NCT01098747|B4|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
230416|NCT01098747|B3|Baseline|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
230417|NCT01098747|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230418|NCT01098747|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets.
230419|NCT01098747|P4|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
230420|NCT01098747|P3|Participant Flow|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
237270|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
230427|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230428|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230429|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230430|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230431|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230432|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230433|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230434|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230435|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230436|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230437|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230438|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230439|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230440|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230441|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230442|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230443|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230444|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230445|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230446|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230447|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230448|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230449|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230450|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230451|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230452|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230453|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230454|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230455|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230456|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230457|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230458|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230459|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230460|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230461|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230462|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
230463|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230464|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230465|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230466|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
230467|NCT01098747|E4|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
230468|NCT01098747|E3|Reported Event|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
230469|NCT01098747|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
230470|NCT01098747|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets.
230471|NCT01098578|B1|Baseline|Floseal|"Received Floseal treatment for posterior epistaxis.~Floseal : Received Floseal as treatment for posterior epistaxis."
230472|NCT01098578|P1|Participant Flow|Floseal.|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
230473|NCT01098578|O2|Outcome|Endoscopic Surgery|The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
230474|NCT01098578|O1|Outcome|FLOSEAL|Institutional cost of treating all study patients with Floseal for posterior epistaxis
230475|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
230476|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
230477|NCT01098578|E1|Reported Event|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
230478|NCT01098539|B3|Baseline|Total|Total of all reporting groups
230479|NCT01098539|B2|Baseline|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230480|NCT01098539|B1|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230481|NCT01098539|P2|Participant Flow|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230482|NCT01098539|P1|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230483|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230484|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230485|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230486|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230487|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230488|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230585|NCT01098318|P3|Participant Flow|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
230586|NCT01098318|P2|Participant Flow|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
230489|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230490|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230491|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230492|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230493|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230494|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230495|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230496|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230497|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230498|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230538|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230499|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230500|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230501|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230502|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230503|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230504|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230505|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230506|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230507|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230508|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230539|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230509|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230510|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230511|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230512|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230513|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230514|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230515|NCT01098539|E2|Reported Event|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230516|NCT01098539|E1|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
230517|NCT01098500|B1|Baseline|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230518|NCT01098500|P1|Participant Flow|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
237271|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
230519|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230520|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230521|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230522|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230523|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230524|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230525|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230526|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230559|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230527|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230528|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230529|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230530|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230531|NCT01098500|E1|Reported Event|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
230532|NCT01098487|B1|Baseline|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230533|NCT01098487|P1|Participant Flow|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230534|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230535|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230536|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230537|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230540|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230541|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230542|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230543|NCT01098487|E1|Reported Event|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
230544|NCT01098461|B5|Baseline|Total|Total of all reporting groups
230545|NCT01098461|B4|Baseline|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230546|NCT01098461|B3|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230547|NCT01098461|B2|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230548|NCT01098461|B1|Baseline|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230549|NCT01098461|P4|Participant Flow|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230550|NCT01098461|P3|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230551|NCT01098461|P2|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230552|NCT01098461|P1|Participant Flow|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230553|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230554|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230555|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230556|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230557|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230558|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230582|NCT01098318|B3|Baseline|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
230560|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230561|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230562|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230563|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230564|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230565|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230566|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230567|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230568|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230569|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230570|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230571|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230572|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230573|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230574|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230575|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230576|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230577|NCT01098461|E4|Reported Event|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230578|NCT01098461|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230579|NCT01098461|E2|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230580|NCT01098461|E1|Reported Event|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
230581|NCT01098318|B4|Baseline|Total|Total of all reporting groups
237272|NCT01077258|O1|Outcome|Month 0|Baseline
230587|NCT01098318|P1|Participant Flow|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
230588|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
230589|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
230590|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
230591|NCT01098318|E3|Reported Event|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
230592|NCT01098318|E2|Reported Event|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
230593|NCT01098318|E1|Reported Event|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
230594|NCT01098305|B3|Baseline|Total|Total of all reporting groups
230595|NCT01098305|B2|Baseline|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
230596|NCT01098305|B1|Baseline|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
230597|NCT01098305|P2|Participant Flow|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
230598|NCT01098305|P1|Participant Flow|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
230599|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
230600|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
230601|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
230602|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
230603|NCT01098305|E2|Reported Event|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
230627|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
240979|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
230604|NCT01098305|E1|Reported Event|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
230605|NCT01098253|B3|Baseline|Total|Total of all reporting groups
230606|NCT01098253|B2|Baseline|Usual Care|
230607|NCT01098253|B1|Baseline|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
230608|NCT01098253|P2|Participant Flow|Usual Care|
230609|NCT01098253|P1|Participant Flow|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
230610|NCT01098253|O2|Outcome|Usual Care|
230611|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
230612|NCT01098253|O2|Outcome|Usual Care|
230613|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
230614|NCT01098253|E2|Reported Event|Usual Care|
230615|NCT01098253|E1|Reported Event|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
230616|NCT01098240|B1|Baseline|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
230617|NCT01098240|P3|Participant Flow|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230618|NCT01098240|P2|Participant Flow|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230619|NCT01098240|P1|Participant Flow|Open-Label Antidepressant Treatment (ADT)|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
230620|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230621|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230622|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230623|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230624|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230625|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230626|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230688|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230628|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230629|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230630|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230631|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230632|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230633|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230634|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230635|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230636|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230637|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230638|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230639|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230640|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230641|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230642|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230643|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230644|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230645|NCT01098240|E3|Reported Event|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230992|NCT01096823|B1|Baseline|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
230646|NCT01098240|E2|Reported Event|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
230647|NCT01098240|E1|Reported Event|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
230648|NCT01098162|B1|Baseline|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230649|NCT01098162|P1|Participant Flow|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230650|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230651|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230652|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230653|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230654|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230655|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230656|NCT01098162|E1|Reported Event|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
230657|NCT01098110|B4|Baseline|Total|Total of all reporting groups
230658|NCT01098110|B3|Baseline|Placebo BID|Participants received matching placebo BID for 6 weeks.
230659|NCT01098110|B2|Baseline|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230660|NCT01098110|B1|Baseline|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230661|NCT01098110|P3|Participant Flow|Placebo BID|Participants received matching placebo BID for 6 weeks.
230662|NCT01098110|P2|Participant Flow|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230663|NCT01098110|P1|Participant Flow|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.
230664|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230665|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230666|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230667|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230668|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230669|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230670|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230671|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230672|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230673|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230674|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230675|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230676|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230677|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230678|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230679|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230680|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230681|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230682|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230683|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230684|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230685|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230686|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230687|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230689|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230690|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230691|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230692|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230693|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230694|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230695|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230696|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230697|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
230698|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230699|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230700|NCT01098110|E3|Reported Event|Placebo BID|Participants received matching placebo BID for 6 weeks.
230701|NCT01098110|E2|Reported Event|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
230702|NCT01098110|E1|Reported Event|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
230703|NCT01098097|B1|Baseline|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230704|NCT01098097|P1|Participant Flow|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230705|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230706|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230707|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230708|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230709|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230710|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230711|NCT01098097|E1|Reported Event|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
230712|NCT01098071|B1|Baseline|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230713|NCT01098071|P1|Participant Flow|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230714|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230715|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230716|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230717|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230718|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230719|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230720|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230721|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230722|NCT01098071|E1|Reported Event|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
230723|NCT01098032|B3|Baseline|Total|Total of all reporting groups
230724|NCT01098032|B2|Baseline|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
230756|NCT01097863|P2|Participant Flow|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
240980|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
230725|NCT01098032|B1|Baseline|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
230726|NCT01098032|P2|Participant Flow|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
230727|NCT01098032|P1|Participant Flow|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
230728|NCT01098032|O2|Outcome|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
230729|NCT01098032|O1|Outcome|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
230730|NCT01098032|E2|Reported Event|Systemic Alone Therapy Group|Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration.
230731|NCT01098032|E1|Reported Event|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure.
230732|NCT01097915|B4|Baseline|Total|Total of all reporting groups
230733|NCT01097915|B3|Baseline|Non Tasters|Subjects no sensitive to PROP
230734|NCT01097915|B2|Baseline|Medium Tasters|Subjects sensitive to PROP
230735|NCT01097915|B1|Baseline|Super Tasters|Subjects highly sensitive to PROP
230736|NCT01097915|P3|Participant Flow|Non Tasters|Subjects no sensitive to PROP
230737|NCT01097915|P2|Participant Flow|Medium Tasters|Subjects sensitive to PROP
230738|NCT01097915|P1|Participant Flow|Super Tasters|Subjects highly sensitive to PROP
230739|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
230740|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
230741|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
230742|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
230743|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
230744|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
230745|NCT01097915|O3|Outcome|Non Tasters|Subjects no sensitive to PROP
230746|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
230747|NCT01097915|O1|Outcome|Super Tasters|Subjects highly sensitive to PROP
230748|NCT01097915|E3|Reported Event|Non Tasters|Subjects no sensitive to PROP
230749|NCT01097915|E2|Reported Event|Medium Tasters|Subjects sensitive to PROP
230750|NCT01097915|E1|Reported Event|Super Tasters|Subjects highly sensitive to PROP
230751|NCT01097863|B4|Baseline|Total|Total of all reporting groups
230752|NCT01097863|B3|Baseline|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
230753|NCT01097863|B2|Baseline|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230754|NCT01097863|B1|Baseline|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230755|NCT01097863|P3|Participant Flow|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
230993|NCT01096823|P2|Participant Flow|Waitlist Control|Standard of care waitlist control group
230757|NCT01097863|P1|Participant Flow|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230758|NCT01097863|O3|Outcome|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
230759|NCT01097863|O2|Outcome|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230760|NCT01097863|O1|Outcome|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230761|NCT01097863|E3|Reported Event|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
230762|NCT01097863|E2|Reported Event|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230763|NCT01097863|E1|Reported Event|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
230764|NCT01097785|B3|Baseline|Total|Total of all reporting groups
230765|NCT01097785|B2|Baseline|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
230766|NCT01097785|B1|Baseline|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
230767|NCT01097785|P2|Participant Flow|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
230768|NCT01097785|P1|Participant Flow|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
230769|NCT01097785|O2|Outcome|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
230770|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
230771|NCT01097785|O2|Outcome|Placebo|Placebo cap 1 pill every day for 30 days
230772|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
230773|NCT01097785|E2|Reported Event|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
230774|NCT01097785|E1|Reported Event|Simvastatin|"40 mg Simvastatin 1 pill every day for 30 days~Simvastatin: 40 mg, P.O.,daily for 30 days"
230775|NCT01097668|B3|Baseline|Total|Total of all reporting groups
230776|NCT01097668|B2|Baseline|Subcutaneous Injection|Injections of ATX-MS-1467 given by the subcutaneous route
230777|NCT01097668|B1|Baseline|Intradermal Injection|Injections of ATX-MS-1467 given by the intradermal route
230778|NCT01097668|P2|Participant Flow|Subcutaneous Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
230779|NCT01097668|P1|Participant Flow|Intradermal Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
230780|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by subcutaneous route
230781|NCT01097668|O1|Outcome|Intradermal|Injections of ATX-MS-1467 administered by intradermal route
230782|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by the subcutaneous route
230783|NCT01097668|O1|Outcome|Intradermal Injection|Injections of ATX-MS-1467 administered by the intradermal route
230784|NCT01097668|E4|Reported Event|Subcutaneous Injection - Non Treatment Emergent|Follow-up period
230785|NCT01097668|E3|Reported Event|Intradermal Injection - Non Treatment Emergent|Follow-up period
230786|NCT01097668|E2|Reported Event|Subcutaneous Injection - Treatment Emergent|Injections will be administered by the subcutaneous route
230787|NCT01097668|E1|Reported Event|Intradermal Injection - Treatment Emergent|Injections will be administered by the intradermal route
230788|NCT01097629|B4|Baseline|Total|Total of all reporting groups
230789|NCT01097629|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230790|NCT01097629|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230791|NCT01097629|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230792|NCT01097629|P8|Participant Flow|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230793|NCT01097629|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230794|NCT01097629|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230795|NCT01097629|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230796|NCT01097629|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230797|NCT01097629|P3|Participant Flow|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
231327|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
230798|NCT01097629|P2|Participant Flow|Suvorexant High Dose (HD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230799|NCT01097629|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230800|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230801|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230802|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230803|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230804|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230805|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230806|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230807|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230808|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230809|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230810|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230811|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230812|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230813|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230814|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230815|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230816|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230817|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230818|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230819|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230820|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230821|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230822|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230823|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230824|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230825|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230826|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230827|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230828|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230829|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230830|NCT01097629|E16|Reported Event|Placebo (RO, After Placebo in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT and RO Phases.
230831|NCT01097629|E15|Reported Event|Placebo (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT Phase and placebo during RO Phase.
230832|NCT01097629|E14|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT and RO Phases.
230833|NCT01097629|E13|Reported Event|Placebo (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT Phase and placebo during RO Phase.
230834|NCT01097629|E12|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT and RO Phases.
230835|NCT01097629|E11|Reported Event|Placebo (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
230836|NCT01097629|E10|Reported Event|Suvorexant HD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
230837|NCT01097629|E9|Reported Event|Suvorexant LD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
230838|NCT01097629|E8|Reported Event|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230839|NCT01097629|E7|Reported Event|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230840|NCT01097629|E6|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230841|NCT01097629|E5|Reported Event|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230842|NCT01097629|E4|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230843|NCT01097629|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
230844|NCT01097629|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230845|NCT01097629|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230846|NCT01097616|B4|Baseline|Total|Total of all reporting groups
230847|NCT01097616|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230848|NCT01097616|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230849|NCT01097616|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230850|NCT01097616|P8|Participant Flow|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230851|NCT01097616|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230852|NCT01097616|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230853|NCT01097616|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230854|NCT01097616|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230989|NCT01096875|E1|Reported Event|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
230855|NCT01097616|P3|Participant Flow|Placebo (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
230856|NCT01097616|P2|Participant Flow|Suvorexant High Dose (HD) (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
230857|NCT01097616|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
230858|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230859|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230860|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230861|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230862|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230863|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230864|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230865|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230866|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230867|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230868|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230869|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230870|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230871|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230872|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230873|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230874|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230875|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230876|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230877|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230878|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230879|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230880|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230881|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230882|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230883|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230990|NCT01096823|B3|Baseline|Total|Total of all reporting groups
230884|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230885|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230886|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230887|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230888|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230889|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230890|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230891|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230892|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230893|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230894|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230895|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230896|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230897|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230898|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230899|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230900|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230901|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230902|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230903|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230904|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230905|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230906|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230907|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230908|NCT01097616|E19|Reported Event|Placebo (RO, After Placebo in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
230909|NCT01097616|E18|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
230910|NCT01097616|E17|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
230911|NCT01097616|E16|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
230912|NCT01097616|E15|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
230991|NCT01096823|B2|Baseline|Waitlist Control|Standard of care waitlist control group
230913|NCT01097616|E14|Reported Event|Placebo (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
230914|NCT01097616|E13|Reported Event|Suvorexant HD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
230915|NCT01097616|E12|Reported Event|Suvorexant LD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
230916|NCT01097616|E11|Reported Event|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230917|NCT01097616|E10|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230918|NCT01097616|E9|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230919|NCT01097616|E8|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
230920|NCT01097616|E7|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
230921|NCT01097616|E6|Reported Event|Placebo (EXT Phase)|After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
230922|NCT01097616|E5|Reported Event|Suvorexant HD (EXT Phase)|After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
230923|NCT01097616|E4|Reported Event|Suvorexant LD (EXT Phase)|After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
230924|NCT01097616|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
230925|NCT01097616|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230926|NCT01097616|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
230927|NCT01096589|B5|Baseline|Total|Total of all reporting groups
230928|NCT01096589|B4|Baseline|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
230929|NCT01096589|B3|Baseline|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230930|NCT01096589|B2|Baseline|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230931|NCT01096589|B1|Baseline|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230932|NCT01096589|P4|Participant Flow|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
230933|NCT01096589|P3|Participant Flow|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230934|NCT01096589|P2|Participant Flow|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230935|NCT01096589|P1|Participant Flow|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230936|NCT01096589|O4|Outcome|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
230937|NCT01096589|O3|Outcome|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230938|NCT01096589|O2|Outcome|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230939|NCT01096589|O1|Outcome|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230940|NCT01096589|E4|Reported Event|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
230941|NCT01096589|E3|Reported Event|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230942|NCT01096589|E2|Reported Event|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230943|NCT01096589|E1|Reported Event|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
230944|NCT01097460|B1|Baseline|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
230945|NCT01097460|P1|Participant Flow|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
230946|NCT01097460|O1|Outcome|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
230947|NCT01097460|E1|Reported Event|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
230948|NCT01097421|B1|Baseline|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230949|NCT01097421|P1|Participant Flow|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230950|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230951|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230952|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230953|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230954|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230955|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230956|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230957|NCT01097421|E1|Reported Event|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
230958|NCT01097343|B1|Baseline|Cross-over Study|All Study Participants
230959|NCT01097343|P2|Participant Flow|150 mg First 30 Days, Followed by 75 mg|25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
230960|NCT01097343|P1|Participant Flow|75 mg First 30 Days, Followed by 150 mg|25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days
230961|NCT01097343|O2|Outcome|Cross-over Study - 150 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
230962|NCT01097343|O1|Outcome|Cross-over Study- 75 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
230963|NCT01097343|E2|Reported Event|150 mg Followed by 75 mg|Cross-over study
230964|NCT01097343|E1|Reported Event|75 mg Followed by 150 mg|Cross-over study
230965|NCT01097304|B1|Baseline|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
230966|NCT01097304|P1|Participant Flow|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
230967|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
230968|NCT01097304|E1|Reported Event|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
230969|NCT01097005|B1|Baseline|Clarithromycin|Those with an exposure
230970|NCT01097005|P1|Participant Flow|Clarithromycin|Those with an exposure
230971|NCT01097005|O1|Outcome|Clarithromycin|The subjects who completed the study
230972|NCT01097005|O1|Outcome|Clarithromycin|Those with an exposure
230973|NCT01097005|O1|Outcome|Clarithromycin|Negative conversion / Yes
230974|NCT01097005|E1|Reported Event|Clarithromycin|Those with an exposure
230975|NCT01096875|B3|Baseline|Total|Total of all reporting groups
230976|NCT01096875|B2|Baseline|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
230977|NCT01096875|B1|Baseline|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
230978|NCT01096875|P2|Participant Flow|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
230979|NCT01096875|P1|Participant Flow|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
230980|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
230981|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
230982|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
230983|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
230984|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
230985|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
230986|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
230987|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
230988|NCT01096875|E2|Reported Event|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
230994|NCT01096823|P1|Participant Flow|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
230995|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
230996|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
230997|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
230998|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
230999|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
231000|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
231001|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
231002|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
231003|NCT01096823|E2|Reported Event|Waitlist Control|Standard of care waitlist control group
231004|NCT01096823|E1|Reported Event|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
231005|NCT01096810|B1|Baseline|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231006|NCT01096810|P1|Participant Flow|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231007|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231008|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231009|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231010|NCT01096810|E1|Reported Event|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
231011|NCT01096771|B3|Baseline|Total|Total of all reporting groups
231012|NCT01096771|B2|Baseline|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231013|NCT01096771|B1|Baseline|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231014|NCT01096771|P2|Participant Flow|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231015|NCT01096771|P1|Participant Flow|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231016|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231017|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231018|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231019|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231020|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231021|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231022|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231023|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231024|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231025|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231026|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231027|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231028|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231029|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231030|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231031|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231032|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231033|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231034|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231035|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231036|NCT01096771|E2|Reported Event|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
231037|NCT01096771|E1|Reported Event|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
231038|NCT01096680|B6|Baseline|Total|Total of all reporting groups
231039|NCT01096680|B5|Baseline|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231040|NCT01096680|B4|Baseline|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231041|NCT01096680|B3|Baseline|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231042|NCT01096680|B2|Baseline|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231043|NCT01096680|B1|Baseline|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231044|NCT01096680|P5|Participant Flow|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231045|NCT01096680|P4|Participant Flow|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231046|NCT01096680|P3|Participant Flow|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231047|NCT01096680|P2|Participant Flow|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231048|NCT01096680|P1|Participant Flow|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231049|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231050|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231051|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231052|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231053|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231054|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231055|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231056|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231057|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231058|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231059|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231060|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231061|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231062|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231063|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231064|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231065|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231066|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231067|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231068|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231069|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231070|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231071|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231072|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231073|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231074|NCT01096680|E5|Reported Event|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231075|NCT01096680|E4|Reported Event|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231076|NCT01096680|E3|Reported Event|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231077|NCT01096680|E2|Reported Event|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231078|NCT01096680|E1|Reported Event|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
231079|NCT01096550|B3|Baseline|Total|Total of all reporting groups
231080|NCT01096550|B2|Baseline|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
231081|NCT01096550|B1|Baseline|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
231082|NCT01096550|P2|Participant Flow|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
231083|NCT01096550|P1|Participant Flow|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
231084|NCT01096550|O2|Outcome|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
231085|NCT01096550|O1|Outcome|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
231086|NCT01096550|E2|Reported Event|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
231087|NCT01096550|E1|Reported Event|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
231088|NCT01096446|B3|Baseline|Total|Total of all reporting groups
240981|NCT01067976|O1|Outcome|CMRM vs UMRM|
231089|NCT01096446|B2|Baseline|Higher Infusion|Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231090|NCT01096446|B1|Baseline|Standard Infusion|Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231091|NCT01096446|P2|Participant Flow|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231092|NCT01096446|P1|Participant Flow|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231093|NCT01096446|O2|Outcome|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231094|NCT01096446|O1|Outcome|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
231095|NCT01096446|E1|Reported Event|Serum Triglycerides|Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
231096|NCT01096342|B1|Baseline|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231097|NCT01096342|P1|Participant Flow|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231098|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231099|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231100|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231101|NCT01096342|E1|Reported Event|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
231102|NCT01096316|B3|Baseline|Total|Total of all reporting groups
231103|NCT01096316|B2|Baseline|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231104|NCT01096316|B1|Baseline|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
231105|NCT01096316|P2|Participant Flow|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231106|NCT01096316|P1|Participant Flow|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
231107|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231328|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231108|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
231109|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231110|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
231111|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231112|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
231113|NCT01096316|E2|Reported Event|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
231114|NCT01096316|E1|Reported Event|Intervention|"The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions."
231115|NCT01096186|B1|Baseline|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231116|NCT01096186|P1|Participant Flow|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231117|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231118|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231119|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231120|NCT01096186|E1|Reported Event|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
231121|NCT01096056|B3|Baseline|Total|Total of all reporting groups
231122|NCT01096056|B2|Baseline|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231123|NCT01096056|B1|Baseline|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231124|NCT01096056|P2|Participant Flow|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231125|NCT01096056|P1|Participant Flow|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231329|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231126|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231127|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231128|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231129|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231130|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231131|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231132|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231133|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231134|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231135|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231136|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231137|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231138|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231139|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231140|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231141|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231142|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231143|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231144|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231145|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231146|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231147|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231148|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231149|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231150|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231151|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231152|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231153|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231154|NCT01096056|E2|Reported Event|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
231155|NCT01096056|E1|Reported Event|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
231156|NCT01096017|B1|Baseline|All Study Participants|
231157|NCT01096017|P2|Participant Flow|Terbutaline First, Then Salbutamol|Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
231158|NCT01096017|P1|Participant Flow|Salbutamol First, Then Terbutaline|Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
231159|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231160|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231161|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231162|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231163|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231164|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231165|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231166|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231167|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231168|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231169|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231170|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231171|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231172|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231173|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231174|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231175|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231176|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231177|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231178|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231179|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231180|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231181|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
231182|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
231183|NCT01096017|E2|Reported Event|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose.
231184|NCT01096017|E1|Reported Event|Salbutamol pMDI|200 μg, inhalation, single dose.
231185|NCT01095978|B1|Baseline|Klacid SR|The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231186|NCT01095978|P1|Participant Flow|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
231187|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231188|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231189|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231190|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231191|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231192|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231193|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231194|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231195|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231196|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231197|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231198|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231199|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231200|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231201|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231202|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231203|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231204|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231205|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231206|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231207|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231208|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
231209|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
231210|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
231211|NCT01095978|E1|Reported Event|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
231282|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
240982|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
231212|NCT01095887|B1|Baseline|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
231213|NCT01095887|P1|Participant Flow|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
231214|NCT01095887|O1|Outcome|Eculizumab|Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
231215|NCT01095887|E1|Reported Event|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
231216|NCT01095835|B4|Baseline|Total|Total of all reporting groups
231217|NCT01095835|B3|Baseline|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231218|NCT01095835|B2|Baseline|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231219|NCT01095835|B1|Baseline|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231220|NCT01095835|P3|Participant Flow|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231221|NCT01095835|P2|Participant Flow|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231222|NCT01095835|P1|Participant Flow|PEG-IFN48|Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231223|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231224|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231225|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231226|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231227|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231228|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231229|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231230|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231231|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231324|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231232|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231233|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231234|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231235|NCT01095835|O1|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231236|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231237|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231238|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231239|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231240|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231241|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231242|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231243|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231244|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231245|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231246|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231247|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231248|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231249|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231250|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231325|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231326|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231251|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231252|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231253|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231254|NCT01095835|E3|Reported Event|PEG-IFN + LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
231255|NCT01095835|E2|Reported Event|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
231256|NCT01095835|E1|Reported Event|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
231257|NCT01095796|B3|Baseline|Total|Total of all reporting groups
231258|NCT01095796|B2|Baseline|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231259|NCT01095796|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231260|NCT01095796|P2|Participant Flow|Atripla|Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231261|NCT01095796|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
231262|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231263|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231264|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231265|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231266|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231267|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231268|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231269|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231270|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231271|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231272|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231273|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231274|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231275|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231276|NCT01095796|E2|Reported Event|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
231277|NCT01095796|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
231278|NCT01095757|B1|Baseline|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231279|NCT01095757|P1|Participant Flow|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).~Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached."
231280|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231281|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231283|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231284|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231285|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231286|NCT01095757|E1|Reported Event|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
231287|NCT01095653|B4|Baseline|Total|Total of all reporting groups
231288|NCT01095653|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231289|NCT01095653|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231290|NCT01095653|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231291|NCT01095653|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231292|NCT01095653|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231293|NCT01095653|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231294|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231295|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231296|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231297|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231298|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231299|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231300|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231301|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231302|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231303|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231304|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231305|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231306|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231307|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231308|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231309|NCT01095653|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231310|NCT01095653|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231311|NCT01095653|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
231312|NCT01095510|B4|Baseline|Total|Total of all reporting groups
231313|NCT01095510|B3|Baseline|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231314|NCT01095510|B2|Baseline|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231315|NCT01095510|B1|Baseline|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231316|NCT01095510|P4|Participant Flow|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231317|NCT01095510|P3|Participant Flow|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231318|NCT01095510|P2|Participant Flow|1000 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231319|NCT01095510|P1|Participant Flow|500 U CINRYZE (10-25 kg Body Weight)|Single intravenous (IV) dose of 500 U CINRYZE
231320|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231321|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231322|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231323|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231330|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231331|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231332|NCT01095510|E3|Reported Event|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
231333|NCT01095510|E2|Reported Event|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
231334|NCT01095510|E1|Reported Event|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
231335|NCT01095497|B3|Baseline|Total|Total of all reporting groups
231336|NCT01095497|B2|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
231337|NCT01095497|B1|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
231338|NCT01095497|P2|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
231339|NCT01095497|P1|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
231340|NCT01095497|O3|Outcome|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
231341|NCT01095497|O2|Outcome|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
231342|NCT01095497|O1|Outcome|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
231343|NCT01095497|E3|Reported Event|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
231344|NCT01095497|E2|Reported Event|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
231345|NCT01095497|E1|Reported Event|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
231346|NCT01095250|B5|Baseline|Total|Total of all reporting groups
231347|NCT01095250|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231348|NCT01095250|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231349|NCT01095250|B2|Baseline|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231350|NCT01095250|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231351|NCT01095250|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231352|NCT01095250|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231353|NCT01095250|P2|Participant Flow|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231354|NCT01095250|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231355|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231356|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231357|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231358|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231359|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231360|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231361|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231362|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231363|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231364|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231365|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231366|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231367|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231368|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231369|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231370|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231371|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231372|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231373|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231374|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231375|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231376|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231377|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231378|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
231379|NCT01095250|E4|Reported Event|Placebo Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
231380|NCT01095250|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
231381|NCT01095250|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
231382|NCT01095250|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
231383|NCT01095094|B1|Baseline|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
231384|NCT01095094|P1|Participant Flow|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
231385|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
231386|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
231387|NCT01095094|E1|Reported Event|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
231388|NCT01094886|B1|Baseline|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231389|NCT01094886|P1|Participant Flow|Rivaroxaban|10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
231390|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231391|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231392|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231393|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231394|NCT01094886|E1|Reported Event|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
231395|NCT01094808|B4|Baseline|Total|Total of all reporting groups
231396|NCT01094808|B3|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231397|NCT01094808|B2|Baseline|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231398|NCT01094808|B1|Baseline|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231399|NCT01094808|P3|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231400|NCT01094808|P2|Participant Flow|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231401|NCT01094808|P1|Participant Flow|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231402|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231403|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231404|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231405|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231406|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231407|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231408|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231409|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231410|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231411|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231412|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231413|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231414|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231415|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231416|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231417|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231418|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231419|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231420|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231421|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231422|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231423|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231424|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231425|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231426|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231427|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231428|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231429|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231430|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231431|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231432|NCT01094808|E3|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
231433|NCT01094808|E2|Reported Event|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
231434|NCT01094808|E1|Reported Event|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
231435|NCT01094743|B1|Baseline|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
231436|NCT01094743|P1|Participant Flow|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
231437|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231438|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231439|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231440|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231441|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231442|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231443|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231444|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231445|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231446|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231447|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231448|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231449|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
231450|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
231451|NCT01094743|E1|Reported Event|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
231452|NCT01094730|B1|Baseline|All Subjects|All enrolled subjects who have the demographic data and worn at least one study lens.
231453|NCT01094730|P2|Participant Flow|Marketed Galyfilcon A/Galyfilcon A Prototype|The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
231454|NCT01094730|P1|Participant Flow|Galyfilcon A Prototype/Marketed Galyfilcon A|The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
231455|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
231456|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
231457|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
231458|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
231459|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
231460|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
231461|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicone hydrogel contact lens.
231462|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicone hydrogel contact lens.
231463|NCT01094730|E1|Reported Event|All Subjects|All subjects were to wear both lenses during the course of the study.
231464|NCT01094704|B3|Baseline|Total|Total of all reporting groups
231465|NCT01094704|B2|Baseline|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
231466|NCT01094704|B1|Baseline|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
231467|NCT01094704|P2|Participant Flow|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
231468|NCT01094704|P1|Participant Flow|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
231469|NCT01094704|O2|Outcome|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
231470|NCT01094704|O1|Outcome|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
231471|NCT01094704|E2|Reported Event|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
231472|NCT01094704|E1|Reported Event|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
231473|NCT01094561|B1|Baseline|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
231474|NCT01094561|P1|Participant Flow|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
231475|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
231476|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
231477|NCT01094561|E1|Reported Event|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
231478|NCT01094548|B3|Baseline|Total|Total of all reporting groups
231479|NCT01094548|B2|Baseline|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231480|NCT01094548|B1|Baseline|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231481|NCT01094548|P2|Participant Flow|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231482|NCT01094548|P1|Participant Flow|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231483|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231484|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231508|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231509|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231513|NCT01093976|B1|Baseline|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
240983|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
231485|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231486|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231487|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231488|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231489|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231490|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231491|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231492|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231510|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231511|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231512|NCT01094171|E1|Reported Event|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231493|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231494|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231495|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231496|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231497|NCT01094548|E2|Reported Event|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
231498|NCT01094548|E1|Reported Event|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
231499|NCT01093222|B1|Baseline|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231500|NCT01093222|P1|Participant Flow|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231501|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231502|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231503|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231504|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231505|NCT01093222|E1|Reported Event|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
231506|NCT01094171|B1|Baseline|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231507|NCT01094171|P1|Participant Flow|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
231514|NCT01093976|P1|Participant Flow|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
231515|NCT01093976|O1|Outcome|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
231516|NCT01093976|E1|Reported Event|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
231517|NCT01093846|B4|Baseline|Total|Total of all reporting groups
231518|NCT01093846|B3|Baseline|AIN457 Placebo|
231519|NCT01093846|B2|Baseline|AIN457 300 mg Monthly|300 mg monthly
231520|NCT01093846|B1|Baseline|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
231521|NCT01093846|P3|Participant Flow|AIN457 Placebo|
231522|NCT01093846|P2|Participant Flow|AIN457 300 mg Monthly|300 mg monthly
231523|NCT01093846|P1|Participant Flow|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
231524|NCT01093846|O1|Outcome|Early Termination|
231525|NCT01093846|E3|Reported Event|Placebo|Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
231526|NCT01093846|E2|Reported Event|AIN457 300mg Monthly|AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
231527|NCT01093846|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
231528|NCT01093794|B1|Baseline|All Participants|
231529|NCT01093794|P4|Participant Flow|4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500 mg metformin~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet"
231530|NCT01093794|P3|Participant Flow|3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500mg metformin"
231531|NCT01093794|P2|Participant Flow|2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin~Co-administration of 50 mg sitagliptin and 500mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet"
231532|NCT01093794|P1|Participant Flow|1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 500 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin"
231533|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
231534|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
231535|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
231536|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
231537|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
231538|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
231539|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
231540|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
231541|NCT01093794|E4|Reported Event|Sit/Met 50 mg/850 mg FDC|AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
231542|NCT01093794|E3|Reported Event|Sit 50 mg + Met 850 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.
231543|NCT01093794|E2|Reported Event|Sit/Met 50 mg/500 mg FDC|AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.
231544|NCT01093794|E1|Reported Event|Sit 50 mg + Met 500 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.
231545|NCT01093755|B3|Baseline|Total|Total of all reporting groups
231546|NCT01093755|B2|Baseline|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
231547|NCT01093755|B1|Baseline|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
231548|NCT01093755|P2|Participant Flow|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
231549|NCT01093755|P1|Participant Flow|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
231550|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
231551|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
231552|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
231747|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
231553|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
231554|NCT01093755|E2|Reported Event|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
231555|NCT01093755|E1|Reported Event|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
231556|NCT01093690|B3|Baseline|Total|Total of all reporting groups
231557|NCT01093690|B2|Baseline|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
231558|NCT01093690|B1|Baseline|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
231559|NCT01093690|P2|Participant Flow|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
231560|NCT01093690|P1|Participant Flow|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
231561|NCT01093690|O2|Outcome|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
231562|NCT01093690|O1|Outcome|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
231563|NCT01093690|E2|Reported Event|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
231564|NCT01093690|E1|Reported Event|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
231565|NCT01093651|B3|Baseline|Total|Total of all reporting groups
231566|NCT01093651|B2|Baseline|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231567|NCT01093651|B1|Baseline|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231568|NCT01093651|P2|Participant Flow|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231569|NCT01093651|P1|Participant Flow|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231570|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231571|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231572|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231573|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231574|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231575|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231576|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231577|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231578|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231579|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231580|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231581|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231582|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231583|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231584|NCT01093651|E2|Reported Event|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
231585|NCT01093651|E1|Reported Event|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
231586|NCT01093625|B3|Baseline|Total|Total of all reporting groups
231587|NCT01093625|B2|Baseline|Spectacles|Subjects are randomized to this Control Group.
231588|NCT01093625|B1|Baseline|Investigational Silicone Hydrogel Contact Lens|Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.
231589|NCT01093625|P2|Participant Flow|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231590|NCT01093625|P1|Participant Flow|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231591|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231592|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231593|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231594|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231595|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231596|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231597|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231598|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231599|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231600|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231601|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231602|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231603|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231604|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231605|NCT01093625|E2|Reported Event|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
231606|NCT01093625|E1|Reported Event|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
231607|NCT01093599|B3|Baseline|Total|Total of all reporting groups
231608|NCT01093599|B2|Baseline|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
231609|NCT01093599|B1|Baseline|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
231610|NCT01093599|P2|Participant Flow|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
231611|NCT01093599|P1|Participant Flow|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
231612|NCT01093599|O2|Outcome|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
231613|NCT01093599|O1|Outcome|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
231614|NCT01093599|E2|Reported Event|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
231615|NCT01093599|E1|Reported Event|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
231616|NCT01093534|B4|Baseline|Total|Total of all reporting groups
231617|NCT01093534|B3|Baseline|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231618|NCT01093534|B2|Baseline|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231619|NCT01093534|B1|Baseline|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231620|NCT01093534|P3|Participant Flow|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231621|NCT01093534|P2|Participant Flow|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231622|NCT01093534|P1|Participant Flow|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231623|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231624|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231625|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231626|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231627|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231628|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231629|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231630|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231631|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231632|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231633|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231634|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231635|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231636|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231637|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231638|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231639|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231640|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231641|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231642|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231643|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231644|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231645|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231646|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231647|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231648|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231649|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231650|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231651|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231652|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231653|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231654|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231655|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231656|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231657|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231658|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231659|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231660|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231661|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231662|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231663|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231664|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231665|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231666|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231667|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231668|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231669|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231670|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231671|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231672|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231673|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231674|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231675|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231676|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231677|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231678|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231679|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231680|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231681|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231682|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231683|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231684|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231685|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231686|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231687|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231688|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231689|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231690|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231691|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231692|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231693|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231694|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231695|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231696|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231697|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231698|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231699|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231700|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231701|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231702|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231703|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231704|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231705|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231706|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231707|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231708|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231709|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231710|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231711|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231712|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231793|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
231713|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231714|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231715|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231716|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231717|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231718|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231719|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
231720|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231721|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231722|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231723|NCT01093534|E3|Reported Event|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
231724|NCT01093534|E2|Reported Event|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
231725|NCT01093534|E1|Reported Event|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
231726|NCT01093521|B1|Baseline|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231727|NCT01093521|P1|Participant Flow|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231728|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231729|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231730|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231731|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231732|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231733|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231734|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231735|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231736|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231737|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231738|NCT01093521|O2|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day"
231739|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day"
231740|NCT01093521|E1|Reported Event|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
231741|NCT01093417|B3|Baseline|Total|Total of all reporting groups
231742|NCT01093417|B2|Baseline|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
231743|NCT01093417|B1|Baseline|Placebo|15 participants were randomized to matching placebo for 12 weeks
231744|NCT01093417|P2|Participant Flow|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
231745|NCT01093417|P1|Participant Flow|Placebo|15 participants were randomized to matching placebo for 12 weeks
231746|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
231748|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
231749|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
231750|NCT01093417|E2|Reported Event|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
231751|NCT01093417|E1|Reported Event|Placebo|15 participants were randomized to matching placebo for 12 weeks
231752|NCT01093027|B3|Baseline|Total|Total of all reporting groups
231753|NCT01093027|B2|Baseline|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
231754|NCT01093027|B1|Baseline|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
231755|NCT01093027|P2|Participant Flow|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
231756|NCT01093027|P1|Participant Flow|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
231757|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
231758|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
231759|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
231760|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
231761|NCT01093027|E2|Reported Event|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
231762|NCT01093027|E1|Reported Event|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
231763|NCT01093014|B4|Baseline|Total|Total of all reporting groups
231764|NCT01093014|B3|Baseline|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
231765|NCT01093014|B2|Baseline|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
231766|NCT01093014|B1|Baseline|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
231767|NCT01093014|P3|Participant Flow|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
231768|NCT01093014|P2|Participant Flow|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
231769|NCT01093014|P1|Participant Flow|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
231770|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
231771|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
231772|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
231773|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
231774|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
231775|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
231776|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
231777|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
231778|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
231779|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
231780|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
231781|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
231782|NCT01093014|E3|Reported Event|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
231783|NCT01093014|E2|Reported Event|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
231784|NCT01093014|E1|Reported Event|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
231785|NCT01092923|B3|Baseline|Total|Total of all reporting groups
231786|NCT01092923|B2|Baseline|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
231787|NCT01092923|B1|Baseline|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
231788|NCT01092923|P2|Participant Flow|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
231789|NCT01092923|P1|Participant Flow|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
231790|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|sevoflurane in air/O2 mix
231791|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|sevoflurane with N20 and Oxygen in 2:1 mix
231792|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
231794|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
231795|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
231796|NCT01092923|E1|Reported Event|N20 With Oxygen (2:1)|sevoflurane with N20 and Oxygen in 2:1 mix
231797|NCT01092910|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
231798|NCT01092910|P1|Participant Flow|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231799|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231800|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231801|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231802|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231803|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231804|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231805|NCT01092910|O1|Outcome|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231806|NCT01092910|E1|Reported Event|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
231807|NCT01092832|B3|Baseline|Total|Total of all reporting groups
231808|NCT01092832|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231809|NCT01092832|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231810|NCT01092832|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231811|NCT01092832|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231864|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231865|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231812|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231813|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231814|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231815|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231816|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231817|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231818|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231819|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231820|NCT01092832|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231866|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231821|NCT01092832|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
231822|NCT01092780|B1|Baseline|All Randomized Participants|All participants who were randomized in the study.
231823|NCT01092780|P4|Participant Flow|Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg|Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
231824|NCT01092780|P3|Participant Flow|Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg|Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
231825|NCT01092780|P2|Participant Flow|MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo|Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
231826|NCT01092780|P1|Participant Flow|MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil|Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
231827|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231828|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231829|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231830|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231831|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231832|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231833|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231834|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231835|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231836|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231837|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231838|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231839|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231840|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231841|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231842|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231843|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231844|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231845|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231846|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231847|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
231848|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231849|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231850|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231851|NCT01092780|E4|Reported Event|Placebo|Participants received single doses of Placebo.
231852|NCT01092780|E3|Reported Event|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
231853|NCT01092780|E2|Reported Event|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
231854|NCT01092780|E1|Reported Event|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
231855|NCT01092767|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|
231856|NCT01092767|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
231857|NCT01092767|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
231858|NCT01092767|E1|Reported Event|1. Rescue|Rescue
231859|NCT01092728|B3|Baseline|Total|Total of all reporting groups
231860|NCT01092728|B2|Baseline|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231861|NCT01092728|B1|Baseline|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231862|NCT01092728|P2|Participant Flow|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231863|NCT01092728|P1|Participant Flow|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
232643|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
231867|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231868|NCT01092728|E2|Reported Event|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231869|NCT01092728|E1|Reported Event|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
231870|NCT01092702|B1|Baseline|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
231871|NCT01092702|P1|Participant Flow|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
231872|NCT01092702|O1|Outcome|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
231873|NCT01092702|E1|Reported Event|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
231874|NCT01092663|B3|Baseline|Total|Total of all reporting groups
231875|NCT01092663|B2|Baseline|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231876|NCT01092663|B1|Baseline|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231877|NCT01092663|P2|Participant Flow|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231878|NCT01092663|P1|Participant Flow|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231879|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231880|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231881|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231882|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231883|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231884|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231885|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231886|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231887|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231888|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231889|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231890|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231891|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231892|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231893|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231894|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231895|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231896|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231897|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
240984|NCT01067976|O1|Outcome|CMRM vs UMRM|
231898|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231899|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231900|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231901|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231902|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231903|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231904|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231905|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231906|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231907|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
231908|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
231909|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231910|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231911|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231912|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231913|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231914|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231915|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100 mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
231916|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231917|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231918|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231919|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
231920|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231921|NCT01092663|E2|Reported Event|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
231922|NCT01092663|E1|Reported Event|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
231923|NCT01092637|B3|Baseline|Total|Total of all reporting groups
231924|NCT01092637|B2|Baseline|Non-cooled|Child was allocated standard intensive care only within 6 hours of birth
231925|NCT01092637|B1|Baseline|Cooled|Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
231958|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231959|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231960|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
240985|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
231926|NCT01092637|P2|Participant Flow|Non-cooled|"Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
231927|NCT01092637|P1|Participant Flow|Cooled|"Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
231928|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
231929|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
231930|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
231931|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
231932|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
231933|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
231934|NCT01092637|E2|Reported Event|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
231935|NCT01092637|E1|Reported Event|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
231936|NCT01092559|B1|Baseline|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide via GeNO Nitrosyl System
231937|NCT01092559|P1|Participant Flow|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
231938|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
231939|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
231940|NCT01092559|E1|Reported Event|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
231941|NCT01092546|B1|Baseline|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
231942|NCT01092546|P1|Participant Flow|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
231943|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
231944|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
231945|NCT01092546|E1|Reported Event|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
231946|NCT01092507|B3|Baseline|Total|Total of all reporting groups
231947|NCT01092507|B2|Baseline|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231948|NCT01092507|B1|Baseline|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231949|NCT01092507|P2|Participant Flow|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231950|NCT01092507|P1|Participant Flow|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231951|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231952|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231953|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231954|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231955|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231956|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231957|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231961|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231962|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231963|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231964|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231965|NCT01092507|E2|Reported Event|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
231966|NCT01092507|E1|Reported Event|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
231967|NCT01092442|B3|Baseline|Total|Total of all reporting groups
231968|NCT01092442|B2|Baseline|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
231969|NCT01092442|B1|Baseline|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
231970|NCT01092442|P2|Participant Flow|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
231971|NCT01092442|P1|Participant Flow|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
231972|NCT01092442|O2|Outcome|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
231973|NCT01092442|O1|Outcome|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
231974|NCT01092442|O4|Outcome|Prospective RVOT|
231975|NCT01092442|O3|Outcome|Retrospective RVOT|
231976|NCT01092442|O2|Outcome|Prospective Ross|
231977|NCT01092442|O1|Outcome|Retrospective Ross|
231978|NCT01092442|O4|Outcome|Prospective RVOT|
231979|NCT01092442|O3|Outcome|Retrospective Right Ventricular Outflow Tract (RVOT)|
231980|NCT01092442|O2|Outcome|Prospective Ross|
231981|NCT01092442|O1|Outcome|Retrospective Ross|
231982|NCT01092442|E2|Reported Event|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
231983|NCT01092442|E1|Reported Event|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
231984|NCT01092416|B1|Baseline|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
231985|NCT01092416|P1|Participant Flow|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
231986|NCT01092416|O1|Outcome|OAS Treatment Group|Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
231987|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
231988|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
231989|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
231990|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
231991|NCT01092416|E2|Reported Event|ORBIT II Subjects - 1 Year Results|Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
231992|NCT01092416|E1|Reported Event|ORBIT II Subjects - 30 Day Results|Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
231993|NCT01092338|B3|Baseline|Total|Total of all reporting groups
231994|NCT01092338|B2|Baseline|7000IU/d Vitamin D3|
231995|NCT01092338|B1|Baseline|4000IU/d of Vitamin D3|
231996|NCT01092338|P2|Participant Flow|7000IU/d Vitamin D3|
231997|NCT01092338|P1|Participant Flow|4000IU/d of Vitamin D3|
231998|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
231999|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
232000|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
232001|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
232002|NCT01092338|E2|Reported Event|7000IU/d Vitamin D3|
232003|NCT01092338|E1|Reported Event|4000IU/d of Vitamin D3|
232004|NCT01091974|B5|Baseline|Total|Total of all reporting groups
232005|NCT01091974|B4|Baseline|4 - Armodafinil Only|"Armodafinil only~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)"
232006|NCT01091974|B3|Baseline|3 - Placebo Only|"Placebo only~Placebo Comparator: Placebo for 47 days"
232007|NCT01091974|B2|Baseline|2 - CBT-I + Armodafinil|"CBT-I + Armodafinil~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232008|NCT01091974|B1|Baseline|1 - CBT-I + Placebo|"CBT-I and placebo~Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232009|NCT01091974|P4|Participant Flow|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
232010|NCT01091974|P3|Participant Flow|3- Placebo Only|Placebo Comparator: Placebo for 47 days
232011|NCT01091974|P2|Participant Flow|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232012|NCT01091974|P1|Participant Flow|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232013|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
232014|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
232015|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232016|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232017|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
232018|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
232019|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232020|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232021|NCT01091974|E4|Reported Event|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
232022|NCT01091974|E3|Reported Event|3- Placebo Only|Placebo Comparator: Placebo for 47 days
232023|NCT01091974|E2|Reported Event|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232024|NCT01091974|E1|Reported Event|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
232025|NCT01091948|B3|Baseline|Total|Total of all reporting groups
232026|NCT01091948|B2|Baseline|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
232027|NCT01091948|B1|Baseline|Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope."
232028|NCT01091948|P2|Participant Flow|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
232029|NCT01091948|P1|Participant Flow|Active Comparator: Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope"
232030|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232031|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232032|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232033|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232034|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232035|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232036|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232037|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232038|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232039|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232040|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232041|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232042|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
232043|NCT01091948|O1|Outcome|Active Comparator: Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
232044|NCT01091948|E2|Reported Event|GlideScope® Video Laryngoscope|Subjects will be intubated with the GlideScope® Video Laryngoscope
232045|NCT01091948|E1|Reported Event|Fiberoptic|Subjects will be intubated with the Fiberoptic laryngoscope.
232046|NCT01091675|B1|Baseline|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
232047|NCT01091675|P1|Participant Flow|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
232048|NCT01091675|O1|Outcome|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
232049|NCT01091675|E1|Reported Event|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
232050|NCT01091662|B3|Baseline|Total|Total of all reporting groups
232051|NCT01091662|B2|Baseline|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232052|NCT01091662|B1|Baseline|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
232087|NCT01091662|E2|Reported Event|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232053|NCT01091662|P2|Participant Flow|ESL1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232054|NCT01091662|P1|Participant Flow|ESL 1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
232055|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232056|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232057|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232058|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232059|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232060|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232061|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232062|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232063|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232064|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232065|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232066|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232067|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232068|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232069|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232070|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232071|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232072|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232073|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
232074|NCT01091662|O1|Outcome|ESL 1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232075|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232076|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232077|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232078|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232079|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232080|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232081|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232082|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232083|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232084|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232085|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
232086|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
232088|NCT01091662|E1|Reported Event|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
232089|NCT01091519|B3|Baseline|Total|Total of all reporting groups
232090|NCT01091519|B2|Baseline|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232091|NCT01091519|B1|Baseline|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232092|NCT01091519|P2|Participant Flow|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232093|NCT01091519|P1|Participant Flow|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232094|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232095|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232096|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232097|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232098|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232099|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232100|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232101|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232102|NCT01091519|E2|Reported Event|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
232103|NCT01091519|E1|Reported Event|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
232104|NCT01091259|B1|Baseline|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
232260|NCT01091103|O1|Outcome|Enzalutamide|
232261|NCT01091103|O1|Outcome|Enzalutamide|
232262|NCT01091103|O1|Outcome|Enzalutamide|
232263|NCT01091103|O1|Outcome|Enzalutamide|
232264|NCT01091103|O1|Outcome|Enzalutamide|
232105|NCT01091259|P1|Participant Flow|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
232106|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232107|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232108|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232109|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232110|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232111|NCT01091259|E1|Reported Event|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
232112|NCT01091246|B4|Baseline|Total|Total of all reporting groups
232113|NCT01091246|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232114|NCT01091246|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232115|NCT01091246|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232116|NCT01091246|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232117|NCT01091246|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232118|NCT01091246|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232119|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232120|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232121|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232265|NCT01091103|O1|Outcome|Enzalutamide|
232266|NCT01091103|O1|Outcome|Enzalutamide|
232267|NCT01091103|O1|Outcome|Enzalutamide|
232122|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232123|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232124|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232125|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232126|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232127|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232128|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232129|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232130|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232131|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232132|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232133|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232134|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232135|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232136|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232137|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232138|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232139|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
235539|NCT01080209|E7|Reported Event|Sham|Patients who received sham in a previous study.
232140|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232141|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232142|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232143|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232144|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232145|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232146|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232147|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232148|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232149|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232150|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232151|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232152|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232153|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232154|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232155|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232156|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232157|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232158|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232159|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232160|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232161|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232162|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232163|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232164|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232165|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232166|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232167|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232168|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232169|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232170|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232268|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
232171|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232172|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232173|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232174|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232175|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232176|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232177|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232178|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232179|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232180|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232181|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232182|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232183|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232184|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232185|NCT01091246|O4|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232186|NCT01091246|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
232269|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
232270|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
232187|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
232188|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232189|NCT01091246|E2|Reported Event|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
232190|NCT01091246|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
232191|NCT01091155|B1|Baseline|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
232192|NCT01091155|P1|Participant Flow|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
232193|NCT01091155|O1|Outcome|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
232194|NCT01091155|E1|Reported Event|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
232195|NCT01091116|B6|Baseline|Total|Total of all reporting groups
232196|NCT01091116|B5|Baseline|Placebo|two doses
232197|NCT01091116|B4|Baseline|Single High Dose|one dose+placebo
232198|NCT01091116|B3|Baseline|High Dose|two doses
232199|NCT01091116|B2|Baseline|Mid Dose|two doses
232200|NCT01091116|B1|Baseline|Low Dose|two doses
232201|NCT01091116|P5|Participant Flow|Placebo|two intra-articular placebo doses
232202|NCT01091116|P4|Participant Flow|Single High Dose|one intra-articular fasitibant dose 0.5 mg +placebo
232203|NCT01091116|P3|Participant Flow|High Dose|two intra-articular fasitibant doses; 0.5 mg each
232204|NCT01091116|P2|Participant Flow|Mid Dose|two intra-articular fasitibant doses; 0.25 mg each
232205|NCT01091116|P1|Participant Flow|Low Dose|two intra-articular fasitibant doses; 0.125 mg each
232206|NCT01091116|O5|Outcome|Placebo|two doses
232207|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232208|NCT01091116|O3|Outcome|High Dose|two doses
232209|NCT01091116|O2|Outcome|Mid Dose|two doses
232210|NCT01091116|O1|Outcome|Low Dose|two doses
232211|NCT01091116|O5|Outcome|Placebo|two doses
232212|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232213|NCT01091116|O3|Outcome|High Dose|two doses
232214|NCT01091116|O2|Outcome|Mid Dose|two doses
232215|NCT01091116|O1|Outcome|Low Dose|two doses
232216|NCT01091116|O5|Outcome|Placebo|two doses
232217|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232218|NCT01091116|O3|Outcome|High Dose|two doses
232219|NCT01091116|O2|Outcome|Mid Dose|two doses
232220|NCT01091116|O1|Outcome|Low Dose|two doses
232221|NCT01091116|O5|Outcome|Placebo|two doses
232222|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232223|NCT01091116|O3|Outcome|High Dose|two doses
232224|NCT01091116|O2|Outcome|Mid Dose|two doses
232225|NCT01091116|O1|Outcome|Low Dose|two doses
232226|NCT01091116|O5|Outcome|Placebo|two doses
232227|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232228|NCT01091116|O3|Outcome|High Dose|two doses
232229|NCT01091116|O2|Outcome|Mid Dose|two doses
232230|NCT01091116|O1|Outcome|Low Dose|two doses
232231|NCT01091116|O5|Outcome|Placebo|two doses
232232|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232233|NCT01091116|O3|Outcome|High Dose|two doses
232234|NCT01091116|O2|Outcome|Mid Dose|two doses
232235|NCT01091116|O1|Outcome|Low Dose|two doses
232236|NCT01091116|O5|Outcome|Placebo|two doses
232237|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232238|NCT01091116|O3|Outcome|High Dose|two doses
232239|NCT01091116|O2|Outcome|Mid Dose|two doses
232240|NCT01091116|O1|Outcome|Low Dose|two doses
232241|NCT01091116|O5|Outcome|Placebo|two doses
232242|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232243|NCT01091116|O3|Outcome|High Dose|two doses
232244|NCT01091116|O2|Outcome|Mid Dose|two doses
232245|NCT01091116|O1|Outcome|Low Dose|two doses
232246|NCT01091116|O5|Outcome|Placebo|two doses
232247|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
232248|NCT01091116|O3|Outcome|High Dose|two doses
232249|NCT01091116|O2|Outcome|Mid Dose|two doses
232250|NCT01091116|O1|Outcome|Low Dose|two doses
232251|NCT01091116|E5|Reported Event|Placebo|two doses
232252|NCT01091116|E4|Reported Event|Single High Dose|one dose+placebo
232253|NCT01091116|E3|Reported Event|High Dose|two doses
232254|NCT01091116|E2|Reported Event|Mid Dose|two doses
232255|NCT01091116|E1|Reported Event|Low Dose|two doses
232256|NCT01091103|B1|Baseline|Enzalutamide|
232257|NCT01091103|P1|Participant Flow|Enzalutamide|
232258|NCT01091103|O1|Outcome|Enzalutamide|
232259|NCT01091103|O1|Outcome|Enzalutamide|
232271|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
232272|NCT01091103|O1|Outcome|Enzalutamide|
232273|NCT01091103|O1|Outcome|Enzalutamide|
232274|NCT01091103|O1|Outcome|Enzalutamide|
232275|NCT01091103|E1|Reported Event|Enzalutamide|
232276|NCT01090973|B1|Baseline|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232277|NCT01090973|P1|Participant Flow|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232278|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232279|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232280|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232281|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232282|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232283|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232284|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232285|NCT01090973|E1|Reported Event|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
232286|NCT01090765|B7|Baseline|Total|Total of all reporting groups
232287|NCT01090765|B6|Baseline|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
232288|NCT01090765|B5|Baseline|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
232289|NCT01090765|B4|Baseline|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
232290|NCT01090765|B3|Baseline|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
232291|NCT01090765|B2|Baseline|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
232292|NCT01090765|B1|Baseline|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
232293|NCT01090765|P6|Participant Flow|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
232294|NCT01090765|P5|Participant Flow|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
232295|NCT01090765|P4|Participant Flow|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
232296|NCT01090765|P3|Participant Flow|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
232297|NCT01090765|P2|Participant Flow|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
232298|NCT01090765|P1|Participant Flow|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
232299|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
232300|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
232301|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
232302|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
232303|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
232304|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
232305|NCT01090765|O1|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
232306|NCT01090765|E6|Reported Event|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
232307|NCT01090765|E5|Reported Event|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
232308|NCT01090765|E4|Reported Event|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
232309|NCT01090765|E3|Reported Event|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
232310|NCT01090765|E2|Reported Event|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
232311|NCT01090765|E1|Reported Event|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
232312|NCT01090752|B3|Baseline|Total|Total of all reporting groups
232313|NCT01090752|B2|Baseline|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232314|NCT01090752|B1|Baseline|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232315|NCT01090752|P2|Participant Flow|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232316|NCT01090752|P1|Participant Flow|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232317|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232318|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232319|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232320|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232321|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232322|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232323|NCT01090752|E2|Reported Event|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
232324|NCT01090752|E1|Reported Event|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
232325|NCT01090739|B1|Baseline|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232326|NCT01090739|P1|Participant Flow|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232327|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
232328|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
232329|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
232330|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232331|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232332|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232333|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232334|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232335|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232336|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232337|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232338|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232339|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232340|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232341|NCT01090739|E1|Reported Event|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
232342|NCT01090479|B3|Baseline|Total|Total of all reporting groups
232343|NCT01090479|B2|Baseline|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
232344|NCT01090479|B1|Baseline|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
232345|NCT01090479|P2|Participant Flow|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
232346|NCT01090479|P1|Participant Flow|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
232347|NCT01090479|O2|Outcome|Chlorhexidine|
232348|NCT01090479|O1|Outcome|Control|
232349|NCT01090479|E2|Reported Event|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
235842|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232350|NCT01090479|E1|Reported Event|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
232351|NCT01090453|B3|Baseline|Total|Total of all reporting groups
232352|NCT01090453|B2|Baseline|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232353|NCT01090453|B1|Baseline|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232354|NCT01090453|P2|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232355|NCT01090453|P1|Participant Flow|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232356|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232357|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232358|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232359|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232360|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232361|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232362|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232363|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232364|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232523|NCT01090063|O1|Outcome|Mean Baseline Pain VAS Score|Average score of the pain VAS at baseline. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
232365|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232366|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232367|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232368|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232369|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232370|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232371|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232372|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232373|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232374|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232375|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232376|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232377|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232391|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
240986|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
232378|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232379|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232380|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232381|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232382|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232383|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232384|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232385|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232386|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232387|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232388|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232389|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232390|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232413|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232637|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232392|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232393|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232394|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232395|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232396|NCT01090453|E2|Reported Event|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232397|NCT01090453|E1|Reported Event|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
232398|NCT01090427|B4|Baseline|Total|Total of all reporting groups
232399|NCT01090427|B3|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232400|NCT01090427|B2|Baseline|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232401|NCT01090427|B1|Baseline|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232402|NCT01090427|P7|Participant Flow|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
232403|NCT01090427|P6|Participant Flow|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
232404|NCT01090427|P5|Participant Flow|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
232405|NCT01090427|P4|Participant Flow|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
232406|NCT01090427|P3|Participant Flow|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
232407|NCT01090427|P2|Participant Flow|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
232408|NCT01090427|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
232409|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232410|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232411|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232412|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
235843|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232414|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232415|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232416|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232417|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232418|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232419|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232420|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232421|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232422|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232423|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232424|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232425|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232426|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232427|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232428|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232429|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232430|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232431|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
232432|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
232433|NCT01090427|E7|Reported Event|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
232434|NCT01090427|E6|Reported Event|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
232435|NCT01090427|E5|Reported Event|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
232436|NCT01090427|E4|Reported Event|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
232437|NCT01090427|E3|Reported Event|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
235844|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232438|NCT01090427|E2|Reported Event|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
232439|NCT01090427|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
232440|NCT01090323|B3|Baseline|Total|Total of all reporting groups
232441|NCT01090323|B2|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232442|NCT01090323|B1|Baseline|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232443|NCT01090323|P2|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232444|NCT01090323|P1|Participant Flow|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232445|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232446|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232447|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232448|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232449|NCT01090323|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232450|NCT01090323|E1|Reported Event|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
232451|NCT01090310|B5|Baseline|Total|Total of all reporting groups
232452|NCT01090310|B4|Baseline|Placebo|Placebo s.c. every 2 weeks
232453|NCT01090310|B3|Baseline|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232454|NCT01090310|B2|Baseline|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232455|NCT01090310|B1|Baseline|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232456|NCT01090310|P4|Participant Flow|Placebo|Placebo s.c. every 2 weeks
232457|NCT01090310|P3|Participant Flow|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232458|NCT01090310|P2|Participant Flow|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232459|NCT01090310|P1|Participant Flow|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232460|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
232461|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232462|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232463|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232464|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
232465|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232466|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232467|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232468|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
232469|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232470|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232471|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232472|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
232473|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232474|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232475|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232476|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
232477|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232478|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
232479|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
232480|NCT01090310|E4|Reported Event|Placebo Every 2 Weeks|Placebo every 2 weeks
232481|NCT01090310|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150mg every 4 weeks
232482|NCT01090310|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300mg every 4 weeks
232483|NCT01090310|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks
232484|NCT01090180|B3|Baseline|Total|Total of all reporting groups
232485|NCT01090180|B2|Baseline|Arm 2: Placebo|Placebo (sugar pill): inactive
232486|NCT01090180|B1|Baseline|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
232487|NCT01090180|P2|Participant Flow|Arm 2: Placebo|Placebo (sugar pill): inactive
232488|NCT01090180|P1|Participant Flow|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
232489|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
232490|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
232491|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
232492|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
232493|NCT01090180|E2|Reported Event|Arm 2: Placebo|Placebo (sugar pill): inactive
232494|NCT01090180|E1|Reported Event|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
232495|NCT01090102|B3|Baseline|Total|Total of all reporting groups
232496|NCT01090102|B2|Baseline|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232497|NCT01090102|B1|Baseline|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232498|NCT01090102|P2|Participant Flow|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232499|NCT01090102|P1|Participant Flow|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232500|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232501|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232502|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232503|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
232504|NCT01090102|E2|Reported Event|Placebo|Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
232505|NCT01090102|E1|Reported Event|Mesalamine|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
232506|NCT01090076|B3|Baseline|Total|Total of all reporting groups
232507|NCT01090076|B2|Baseline|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232508|NCT01090076|B1|Baseline|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232509|NCT01090076|P2|Participant Flow|Placebo|Placebo x 2 sachets/d
232510|NCT01090076|P1|Participant Flow|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
232511|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232512|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232513|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232514|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232515|NCT01090076|O2|Outcome|Placebo|Placebo x 2 sachets/d
232516|NCT01090076|O1|Outcome|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
232517|NCT01090076|E2|Reported Event|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232518|NCT01090076|E1|Reported Event|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
232519|NCT01090063|B1|Baseline|Main|
232520|NCT01090063|P1|Participant Flow|Main|All participants were treated the same
232521|NCT01090063|O1|Outcome|Number of Participants With AEs|
232522|NCT01090063|O2|Outcome|Mean Week 24 Pain VAS Score|Average score of the pain VAS at Week 24. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
232638|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232524|NCT01090063|O2|Outcome|Mean Week 24 Pruritus VAS Score|Average pruritus VAS score as measured at week 24. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
232525|NCT01090063|O1|Outcome|Mean Baseline Pruritus VAS Score|Average pruritus VAS score as measured at baseline. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
232526|NCT01090063|O2|Outcome|Mean Week 24 Fissure Count|Average number of fissures found on hands and feet at Week 24
232527|NCT01090063|O1|Outcome|Mean Baseline Fissure Count|Average number of fissures found on hands and feet at baseline
232528|NCT01090063|O2|Outcome|Mean Pustule Count at Week 24|Average number of pustules present in all subjects at week 24
232529|NCT01090063|O1|Outcome|Mean Pustule Count at Baseline|Average number of pustules present in all subjects at baseline
232530|NCT01090063|O1|Outcome|Median PGA|Median PGA at Week 24
232531|NCT01090063|O1|Outcome|Main|Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.
232532|NCT01090063|E1|Reported Event|Main|
232533|NCT01090050|B3|Baseline|Total|Total of all reporting groups
232534|NCT01090050|B2|Baseline|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
232535|NCT01090050|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
232536|NCT01090050|P2|Participant Flow|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232537|NCT01090050|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232538|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232539|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232540|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232541|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232542|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232543|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232544|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232639|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232545|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232546|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232547|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232548|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232549|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232550|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232551|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232552|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232553|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
232554|NCT01090050|E2|Reported Event|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
232555|NCT01090050|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
232556|NCT01090011|B1|Baseline|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
232557|NCT01090011|P1|Participant Flow|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
232558|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
235845|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232559|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232560|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232561|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232562|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232563|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232564|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232565|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232566|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232567|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232568|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232569|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232570|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232571|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232572|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232573|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232574|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232575|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232576|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232577|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232578|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232579|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232580|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232581|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232640|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232582|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232583|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232584|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232585|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232586|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232587|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232588|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232589|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232590|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232591|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232592|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232593|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232594|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232595|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232596|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232597|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232598|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232599|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232600|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232601|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232602|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232603|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232604|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232605|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232641|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232642|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232606|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232607|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232608|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232609|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232610|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232611|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232612|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232613|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232614|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232615|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
232616|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232617|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232618|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
232619|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
232620|NCT01090011|E4|Reported Event|Sequential Arm - Combination Therapy (Afa40+Ctx500)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
232621|NCT01090011|E3|Reported Event|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
232622|NCT01090011|E2|Reported Event|Combination Arm - Afa40+Ctx500|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
232623|NCT01090011|E1|Reported Event|Combination Arm - Afa40+Ctx250|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
232624|NCT01089751|B3|Baseline|Total|Total of all reporting groups
232625|NCT01089751|B2|Baseline|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232626|NCT01089751|B1|Baseline|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232627|NCT01089751|P2|Participant Flow|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232628|NCT01089751|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232629|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232630|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232631|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232632|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232633|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232634|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232635|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232636|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232644|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232645|NCT01089751|E2|Reported Event|Placebo|Placebo once daily on an empty stomach for 14 weeks.
232646|NCT01089751|E1|Reported Event|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
232647|NCT01089608|B3|Baseline|Total|Total of all reporting groups
232648|NCT01089608|B2|Baseline|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232649|NCT01089608|B1|Baseline|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232650|NCT01089608|P2|Participant Flow|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232651|NCT01089608|P1|Participant Flow|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232652|NCT01089608|O2|Outcome|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232653|NCT01089608|O1|Outcome|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232654|NCT01089608|E2|Reported Event|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232655|NCT01089608|E1|Reported Event|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
232656|NCT01089582|B1|Baseline|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232657|NCT01089582|P1|Participant Flow|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232658|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232659|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232660|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232661|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232662|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232663|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232664|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232665|NCT01089582|E1|Reported Event|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
232666|NCT01089556|B3|Baseline|Total|Total of all reporting groups
232667|NCT01089556|B2|Baseline|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232668|NCT01089556|B1|Baseline|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232669|NCT01089556|P6|Participant Flow|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
232670|NCT01089556|P5|Participant Flow|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
232671|NCT01089556|P4|Participant Flow|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
232672|NCT01089556|P3|Participant Flow|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
232673|NCT01089556|P2|Participant Flow|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232674|NCT01089556|P1|Participant Flow|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
232675|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232676|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232677|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232678|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232679|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232680|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232681|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232682|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232683|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232684|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232685|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232686|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232687|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232688|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232689|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232690|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232691|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232692|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232693|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232694|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232695|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232696|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232697|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232698|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232699|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232700|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232701|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232702|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232703|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232704|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232705|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232706|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232707|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232708|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232709|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232710|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232711|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232712|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232713|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232714|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232715|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232716|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232717|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232718|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232719|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232720|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232721|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232722|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232723|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232724|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232725|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232726|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232727|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232728|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232729|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232730|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232731|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232732|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232733|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
235846|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232734|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
232735|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
232736|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
232737|NCT01089556|E6|Reported Event|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
232738|NCT01089556|E5|Reported Event|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
232739|NCT01089556|E4|Reported Event|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
232740|NCT01089556|E3|Reported Event|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
232741|NCT01089556|E2|Reported Event|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
232742|NCT01089556|E1|Reported Event|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
232743|NCT01089543|B5|Baseline|Total|Total of all reporting groups
232744|NCT01089543|B4|Baseline|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
232745|NCT01089543|B3|Baseline|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
232746|NCT01089543|B2|Baseline|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
232747|NCT01089543|B1|Baseline|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
232748|NCT01089543|P4|Participant Flow|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
232749|NCT01089543|P3|Participant Flow|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
232750|NCT01089543|P2|Participant Flow|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
232751|NCT01089543|P1|Participant Flow|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
232752|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
232753|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
232754|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
232755|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
232756|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
232757|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
232758|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
232759|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
232760|NCT01089543|E4|Reported Event|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
232761|NCT01089543|E3|Reported Event|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
232762|NCT01089543|E2|Reported Event|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
232763|NCT01089543|E1|Reported Event|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
232764|NCT01089517|B4|Baseline|Total|Total of all reporting groups
232765|NCT01089517|B3|Baseline|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232766|NCT01089517|B2|Baseline|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232767|NCT01089517|B1|Baseline|Lucentis|Sham/Lucentis 0.5 mg
232768|NCT01089517|P3|Participant Flow|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232769|NCT01089517|P2|Participant Flow|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232770|NCT01089517|P1|Participant Flow|Lucentis|Sham/Lucentis 0.5 mg
232771|NCT01089517|O3|Outcome|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232772|NCT01089517|O2|Outcome|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232773|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
232774|NCT01089517|O3|Outcome|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232775|NCT01089517|O2|Outcome|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232776|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
232777|NCT01089517|O3|Outcome|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232778|NCT01089517|O2|Outcome|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232779|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
232780|NCT01089517|E3|Reported Event|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
232781|NCT01089517|E2|Reported Event|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
232782|NCT01089517|E1|Reported Event|Lucentis|Sham/Lucentis 0.5 mg
232783|NCT01089504|B3|Baseline|Total|Total of all reporting groups
232784|NCT01089504|B2|Baseline|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232785|NCT01089504|B1|Baseline|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
235847|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
232786|NCT01089504|P2|Participant Flow|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232787|NCT01089504|P1|Participant Flow|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
232788|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232789|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
232790|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232791|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
232792|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232793|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
232794|NCT01089504|E2|Reported Event|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
232795|NCT01089504|E1|Reported Event|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
232796|NCT01089413|B4|Baseline|Total|Total of all reporting groups
232797|NCT01089413|B3|Baseline|Bevacizumab: Age >80 Years|Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232798|NCT01089413|B2|Baseline|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232799|NCT01089413|B1|Baseline|Bevacizumab: Age <70 Years|Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232800|NCT01089413|P1|Participant Flow|Bevacizumab: Overall|All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232801|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232802|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232803|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232804|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232805|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232806|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232807|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232808|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232839|NCT01089231|E2|Reported Event|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232809|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232810|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
232811|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232812|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232813|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
232814|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232815|NCT01089413|E1|Reported Event|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
232816|NCT01089231|B5|Baseline|Total|Total of all reporting groups
232817|NCT01089231|B4|Baseline|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232818|NCT01089231|B3|Baseline|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232819|NCT01089231|B2|Baseline|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232820|NCT01089231|B1|Baseline|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232821|NCT01089231|P4|Participant Flow|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232822|NCT01089231|P3|Participant Flow|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232823|NCT01089231|P2|Participant Flow|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232824|NCT01089231|P1|Participant Flow|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232825|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232826|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232827|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232828|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232829|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232830|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232831|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232832|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232833|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232834|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232835|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
232836|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232837|NCT01089231|E4|Reported Event|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
232838|NCT01089231|E3|Reported Event|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
232840|NCT01089231|E1|Reported Event|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
232841|NCT01089127|B7|Baseline|Total|Total of all reporting groups
232842|NCT01089127|B6|Baseline|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232843|NCT01089127|B5|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232844|NCT01089127|B4|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232845|NCT01089127|B3|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232846|NCT01089127|B2|Baseline|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232847|NCT01089127|B1|Baseline|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232848|NCT01089127|P6|Participant Flow|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232849|NCT01089127|P5|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232850|NCT01089127|P4|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232851|NCT01089127|P3|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232852|NCT01089127|P2|Participant Flow|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232853|NCT01089127|P1|Participant Flow|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232854|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
240987|NCT01067976|O1|Outcome|CMRM vs UMRM|
232855|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232856|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232857|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232858|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232859|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232860|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232861|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232862|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232863|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232864|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232865|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232866|NCT01089127|E6|Reported Event|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232867|NCT01089127|E5|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232885|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232886|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
240988|NCT01067976|O5|Outcome|CMRM+XRM|
232868|NCT01089127|E4|Reported Event|Indacaterol 150 ug|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232869|NCT01089127|E3|Reported Event|Indacaterol 75 ug|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232870|NCT01089127|E2|Reported Event|Indacaterol 37.5 ug|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232871|NCT01089127|E1|Reported Event|Indacaterol 18.75 ug|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
232872|NCT01089062|B7|Baseline|Total|Total of all reporting groups
232873|NCT01089062|B6|Baseline|Treatment C, Then B, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232874|NCT01089062|B5|Baseline|Treatment C, Then A, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232875|NCT01089062|B4|Baseline|Treatment B, Then C, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232876|NCT01089062|B3|Baseline|Treatment B, Then A, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232877|NCT01089062|B2|Baseline|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232878|NCT01089062|B1|Baseline|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
232879|NCT01089062|P6|Participant Flow|Treatment C, Then B, Then A|"The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
232880|NCT01089062|P5|Participant Flow|Treatment C, Then A, Then B|"The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
232881|NCT01089062|P4|Participant Flow|Treatment B, Then C, Then A|"The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
232882|NCT01089062|P3|Participant Flow|Treatment B, Then A, Then C|"The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
232883|NCT01089062|P2|Participant Flow|Treatment A, Then C, Then B|"The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
232884|NCT01089062|P1|Participant Flow|Treatment A, Then B, Then C|"The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
240989|NCT01067976|O4|Outcome|UMRM+XRM|
232887|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232888|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232889|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232890|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232891|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232892|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232893|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose 2 hours from time of first dose.
232894|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232895|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232896|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232897|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232898|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232899|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232900|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232901|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232902|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232903|NCT01089062|E3|Reported Event|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
232904|NCT01089062|E2|Reported Event|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
232905|NCT01089062|E1|Reported Event|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
232906|NCT01089023|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232907|NCT01089023|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
232908|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232909|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232910|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232911|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232912|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232913|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232914|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232915|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232916|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
232917|NCT01089023|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
232918|NCT01088997|B3|Baseline|Total|Total of all reporting groups
232919|NCT01088997|B2|Baseline|Low Dose Milrinone|Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
232920|NCT01088997|B1|Baseline|High Dose Milrinone|Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
232921|NCT01088997|P2|Participant Flow|Low Dose Milrinone|Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.
232922|NCT01088997|P1|Participant Flow|High Dose Milrinone|Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
232923|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into the study, of these 2 completed study treatment and only 1 received 2 MPI measurements
232924|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into the study, of these 4 completed study treatment.
232925|NCT01088997|O1|Outcome|Milrinone Population|Population model developed based on 6 subjects who completed study treatment and were deemed evaluable.
232926|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into this arm, of these only 2 completed study treatment.
232927|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into this arm, of these only 4 completed study treatment.
232928|NCT01088997|E2|Reported Event|Low Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
232929|NCT01088997|E1|Reported Event|High Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
232930|NCT01088984|B3|Baseline|Total|Total of all reporting groups
232962|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
232931|NCT01088984|B2|Baseline|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232932|NCT01088984|B1|Baseline|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232933|NCT01088984|P2|Participant Flow|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232934|NCT01088984|P1|Participant Flow|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232935|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232936|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232937|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232938|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232939|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232940|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232941|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232942|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232943|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232944|NCT01088984|O3|Outcome|Total|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232945|NCT01088984|O2|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232946|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232947|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232948|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232949|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232950|NCT01088984|E1|Reported Event|Bendamustine|Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
232951|NCT01088711|B5|Baseline|Total|Total of all reporting groups
232952|NCT01088711|B4|Baseline|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
232953|NCT01088711|B3|Baseline|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
232954|NCT01088711|B2|Baseline|T2D Participants (Panel B)|Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
232955|NCT01088711|B1|Baseline|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
232956|NCT01088711|P4|Participant Flow|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
232957|NCT01088711|P3|Participant Flow|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
232958|NCT01088711|P2|Participant Flow|Healthy - Placebo|Obese healthy participants received once-weekly placebo for 4 weeks.
232959|NCT01088711|P1|Participant Flow|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
232960|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
232961|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232963|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232964|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
232965|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232966|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
232967|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232968|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
232969|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232970|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
232971|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
232972|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
232973|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
232974|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
232975|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
232976|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
232977|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
232978|NCT01088711|E4|Reported Event|Placebo T2D (Panel B)|Obese T2D participants received once-weekly placebo for 4 weeks.
232979|NCT01088711|E3|Reported Event|Omarigliptin 50 mg T2D (Panel B)|Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
232980|NCT01088711|E2|Reported Event|Placebo Healthy (Panel A)|Obese healthy participants received once-weekly placebo for 4 weeks.
232981|NCT01088711|E1|Reported Event|Omarigliptin 50 mg Healthy (Panel A)|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
232982|NCT01088672|B1|Baseline|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232983|NCT01088672|P1|Participant Flow|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232984|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232985|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232986|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232987|NCT01088672|E1|Reported Event|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
232988|NCT01088646|B1|Baseline|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
232989|NCT01088646|P1|Participant Flow|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
232990|NCT01088646|O1|Outcome|Pillcam Express Capsule Delivery System|The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
232991|NCT01088646|E1|Reported Event|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
232992|NCT01088529|B3|Baseline|Total|Total of all reporting groups
232993|NCT01088529|B2|Baseline|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
232994|NCT01088529|B1|Baseline|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
240990|NCT01067976|O3|Outcome|X-ray Mammography (XRM)|
232995|NCT01088529|P2|Participant Flow|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
232996|NCT01088529|P1|Participant Flow|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
232997|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
232998|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
232999|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
233000|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
233001|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
233002|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
233003|NCT01088529|E2|Reported Event|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
233004|NCT01088529|E1|Reported Event|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
233005|NCT01088503|B4|Baseline|Total|Total of all reporting groups
233006|NCT01088503|B3|Baseline|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
233007|NCT01088503|B2|Baseline|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233008|NCT01088503|B1|Baseline|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233009|NCT01088503|P3|Participant Flow|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
233010|NCT01088503|P2|Participant Flow|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233011|NCT01088503|P1|Participant Flow|Prasugrel|Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233012|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
233013|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233014|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
233015|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233016|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233017|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233018|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233019|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233020|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233021|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233022|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233023|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
235848|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
233024|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233025|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233026|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
233027|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233028|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233029|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233030|NCT01088503|E1|Reported Event|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
233031|NCT01088464|B4|Baseline|Total|Total of all reporting groups
233032|NCT01088464|B3|Baseline|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233033|NCT01088464|B2|Baseline|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233034|NCT01088464|B1|Baseline|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233035|NCT01088464|P3|Participant Flow|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233036|NCT01088464|P2|Participant Flow|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233037|NCT01088464|P1|Participant Flow|Cohort 1: Necitumumab|Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233038|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233039|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233040|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233041|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233042|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233043|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233044|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233045|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233046|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233047|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233103|NCT01088399|P3|Participant Flow||It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233048|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233049|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233050|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233051|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233052|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233053|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233054|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233055|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233056|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233057|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233058|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233059|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233060|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233061|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233062|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233063|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233064|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233065|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233066|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233067|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233068|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233069|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
246495|NCT01048593|O3|Outcome|Dose 3|684ug dose group
233070|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233071|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233072|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233073|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233074|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233075|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233076|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233077|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233078|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233079|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233080|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233081|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233082|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233083|NCT01088464|E3|Reported Event|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233084|NCT01088464|E2|Reported Event|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233085|NCT01088464|E1|Reported Event|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
233086|NCT01088438|B3|Baseline|Total|Total of all reporting groups
233087|NCT01088438|B2|Baseline|Control|No intervention
233088|NCT01088438|B1|Baseline|Contextualization Workshop|A four-hour course on contextualization.
233089|NCT01088438|P2|Participant Flow|Control|No intervention
233090|NCT01088438|P1|Participant Flow|Contextualization Workshop|A four-hour course on contextualization.
233091|NCT01088438|O2|Outcome|Control|No intervention
233092|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
233093|NCT01088438|O2|Outcome|Control|No intervention
233094|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
233095|NCT01088438|O2|Outcome|Control|No intervention
233096|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
233097|NCT01088438|E2|Reported Event|Control|No intervention
233098|NCT01088438|E1|Reported Event|Contextualization Workshop|A four-hour course on contextualization.
233099|NCT01088399|B4|Baseline|Total|Total of all reporting groups
233100|NCT01088399|B3|Baseline|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233101|NCT01088399|B2|Baseline|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233102|NCT01088399|B1|Baseline|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
235849|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
233104|NCT01088399|P2|Participant Flow|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233105|NCT01088399|P1|Participant Flow|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233106|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233107|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233108|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233109|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233110|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233111|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233112|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233113|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233114|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233115|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233116|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233117|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233118|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233119|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233120|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233121|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233122|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233123|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233124|NCT01088399|E3|Reported Event||It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233125|NCT01088399|E2|Reported Event|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
233126|NCT01088399|E1|Reported Event|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
233127|NCT01088295|B1|Baseline|Telmisartan|Telmisartan 40mg po daily for 24 weeks
233128|NCT01088295|P1|Participant Flow|Telmisartan|Telmisartan 40mg po daily for 24 weeks
233129|NCT01088295|O1|Outcome|Telmisartan|Telmisartan 40mg po daily for 24 weeks
233130|NCT01088295|E1|Reported Event|Telmisartan|
233131|NCT01087996|B3|Baseline|Total|Total of all reporting groups
233132|NCT01087996|B2|Baseline|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233133|NCT01087996|B1|Baseline|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233134|NCT01087996|P2|Participant Flow|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233169|NCT01087957|P2|Participant Flow|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
246496|NCT01048593|O2|Outcome|Dose 2|513ug dose group
233135|NCT01087996|P1|Participant Flow|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233136|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233137|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233138|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233139|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233140|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233141|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233142|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233143|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233144|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233170|NCT01087957|P1|Participant Flow|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233171|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233145|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233146|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233147|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233148|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233149|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233150|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233151|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233152|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233153|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233154|NCT01087996|E2|Reported Event|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233172|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233173|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233155|NCT01087996|E1|Reported Event|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
233156|NCT01087970|B1|Baseline|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233157|NCT01087970|P1|Participant Flow|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233158|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233159|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233160|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233161|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233162|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233163|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233164|NCT01087970|E2|Reported Event|Cetuximab + Pemetrexed + Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233165|NCT01087970|E1|Reported Event|Cetuximab + Pemetrexed + Carboplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
233166|NCT01087957|B3|Baseline|Total|Total of all reporting groups
233167|NCT01087957|B2|Baseline|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233168|NCT01087957|B1|Baseline|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
246497|NCT01048593|O1|Outcome|Dose 1|114ug dose group
233174|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233175|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233176|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233177|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233178|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233179|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233180|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233181|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233182|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233183|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233184|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233185|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233186|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233187|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233188|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233189|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233190|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233191|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233192|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233193|NCT01087957|E2|Reported Event|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233194|NCT01087957|E1|Reported Event|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
233195|NCT01087944|B1|Baseline|Overall|Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator’s judgment.
233196|NCT01087944|P2|Participant Flow|Sequence 2 (Pre-filled Syringe Then Auto-Injector)|Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
233197|NCT01087944|P1|Participant Flow|Sequence 1 (Auto-Injector Then Pre-filled Syringe)|Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
233198|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233199|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233200|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233201|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233531|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233532|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233202|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233203|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233204|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233205|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233206|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233207|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233208|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233209|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233210|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233211|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233212|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233213|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233214|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233215|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233216|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233217|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233533|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233218|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233219|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233220|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233221|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233222|NCT01087944|E2|Reported Event|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
233223|NCT01087944|E1|Reported Event|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
233224|NCT01087918|B3|Baseline|Total|Total of all reporting groups
233225|NCT01087918|B2|Baseline|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
233226|NCT01087918|B1|Baseline|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
233227|NCT01087918|P2|Participant Flow|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
233228|NCT01087918|P1|Participant Flow|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
233229|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233230|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233231|NCT01087918|O2|Outcome|First Strength Training, Then RAGT|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233232|NCT01087918|O1|Outcome|First RAGT, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233233|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233234|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233235|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233236|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233237|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233238|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233239|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233240|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233241|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233242|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233243|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233244|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233245|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of strength training 4 times a week
233246|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week
233247|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233248|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233249|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233250|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
233251|NCT01087918|E2|Reported Event|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
233252|NCT01087918|E1|Reported Event|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
233253|NCT01087905|B9|Baseline|Total|Total of all reporting groups
233254|NCT01087905|B8|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233255|NCT01087905|B7|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233256|NCT01087905|B6|Baseline|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233257|NCT01087905|B5|Baseline|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233258|NCT01087905|B4|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233259|NCT01087905|B3|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233260|NCT01087905|B2|Baseline|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233261|NCT01087905|B1|Baseline|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233262|NCT01087905|P8|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233263|NCT01087905|P7|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233264|NCT01087905|P6|Participant Flow|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233265|NCT01087905|P5|Participant Flow|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233266|NCT01087905|P4|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233267|NCT01087905|P3|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233268|NCT01087905|P2|Participant Flow|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
233269|NCT01087905|P1|Participant Flow|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
233270|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
233271|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
233272|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
233273|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
233274|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
233275|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
233276|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
233277|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
233309|NCT01087788|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233534|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233278|NCT01087905|O6|Outcome|Standard Cessation Counseling Plus CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
233279|NCT01087905|O5|Outcome|Standard Cessation Counseling (No CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
233280|NCT01087905|O4|Outcome|NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)|Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
233281|NCT01087905|O3|Outcome|NRT Monotherapy (Nicotine Patch Only)|Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
233282|NCT01087905|O2|Outcome|Six Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
233283|NCT01087905|O1|Outcome|Two Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
233284|NCT01087905|E4|Reported Event|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
233285|NCT01087905|E3|Reported Event|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
233286|NCT01087905|E2|Reported Event|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
233287|NCT01087905|E1|Reported Event|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
233288|NCT01087814|B3|Baseline|Total|Total of all reporting groups
233289|NCT01087814|B2|Baseline|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
233290|NCT01087814|B1|Baseline|Efavirenz|Both arms received both versions of the drug during the course of the study.
233291|NCT01087814|P2|Participant Flow|Over-encapsulated Efavirenz First, Then Efavirenz|This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
233292|NCT01087814|P1|Participant Flow|Efavirenz First, Then Over-encapsulated Efavirenz|This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
233293|NCT01087814|O2|Outcome|Over-encapsulated Efavirenz|All subjects took over-encapsulated efavirenz.
233294|NCT01087814|O1|Outcome|Efavirenz (Tablet)|All subjects took efavirenz.
233295|NCT01087814|E2|Reported Event|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
233296|NCT01087814|E1|Reported Event|Efavirenz|Both arms received both versions of the drug during the course of the study.
233297|NCT01087801|B3|Baseline|Total|Total of all reporting groups
233298|NCT01087801|B2|Baseline|Placebo|Saline for Injection 0.1 mL/kg IV
233299|NCT01087801|B1|Baseline|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
233300|NCT01087801|P2|Participant Flow|Placebo|Saline for Injection 0.1 mL/kg IV
233301|NCT01087801|P1|Participant Flow|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
233302|NCT01087801|O2|Outcome|Placebo|Saline for Injection 0.1 mL/kg IV
233303|NCT01087801|O1|Outcome|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
233304|NCT01087801|E2|Reported Event|Placebo|Saline for Injection 0.1 mL/kg IV
233305|NCT01087801|E1|Reported Event|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
233306|NCT01087788|B4|Baseline|Total Title|
233307|NCT01087788|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233308|NCT01087788|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233535|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233536|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233310|NCT01087788|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233311|NCT01087788|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233312|NCT01087788|P1|Participant Flow|Placebo|"Matching Placebo (PBO) to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233313|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
233314|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233315|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233316|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233317|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
233318|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233319|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233320|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233321|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
233322|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233323|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233324|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233325|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233326|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233327|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233537|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
246498|NCT01048593|E3|Reported Event|Dose 3|684ug dose group
233328|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
233329|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233330|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233331|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233332|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
233333|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
233334|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
233335|NCT01087788|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg Q2W and arm All CZP 400 mg Q4W.
233336|NCT01087788|E2|Reported Event|All CZP 400 mg Q4W|"This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.~Subjects received two injections of Placebo every four weeks in between the two injections of 200 mg CZP to maintain the study blind."
233337|NCT01087788|E1|Reported Event|All CZP 200 mg Q2W|"This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.~Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind."
233338|NCT01087762|B4|Baseline|Total Title|
233339|NCT01087762|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233340|NCT01087762|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233341|NCT01087762|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233342|NCT01087762|P5|Participant Flow|All CZP 400 mg|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233343|NCT01087762|P4|Participant Flow|All CZP 200 mg|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233344|NCT01087762|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233345|NCT01087762|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233346|NCT01087762|P1|Participant Flow|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
235850|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
233347|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233348|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233349|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233350|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233351|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233352|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233353|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233354|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233355|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233356|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233357|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233358|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233359|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233360|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233538|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233539|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233361|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233362|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233363|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233364|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233365|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233366|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233367|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233368|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233369|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233370|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233371|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233372|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233373|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233374|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233390|NCT01087762|E1|Reported Event|All CZP 200 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233391|NCT01087736|B3|Baseline|Total|Total of all reporting groups
233375|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233376|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233377|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233378|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233379|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233380|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233381|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233382|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233383|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233384|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233385|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
233386|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233387|NCT01087762|E4|Reported Event|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
233388|NCT01087762|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
233389|NCT01087762|E2|Reported Event|All CZP 400 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
233540|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233541|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233392|NCT01087736|B2|Baseline|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
233393|NCT01087736|B1|Baseline|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
233394|NCT01087736|P2|Participant Flow|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
233395|NCT01087736|P1|Participant Flow|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
233396|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
233397|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
233398|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
233399|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
233400|NCT01087736|E2|Reported Event|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
233401|NCT01087736|E1|Reported Event|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
233402|NCT01087723|B3|Baseline|Total|Total of all reporting groups
233403|NCT01087723|B2|Baseline|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233404|NCT01087723|B1|Baseline|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233405|NCT01087723|P2|Participant Flow|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as heparins with optional GPI.”"
233406|NCT01087723|P1|Participant Flow|Bivalirudin|Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233447|NCT01087528|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
233448|NCT01087528|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
233407|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233408|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233409|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233410|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233411|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233412|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233413|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233414|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233415|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233416|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233417|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233418|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233419|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233420|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233421|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233422|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233423|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233424|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233425|NCT01087723|E2|Reported Event|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
233426|NCT01087723|E1|Reported Event|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
233427|NCT01087541|B3|Baseline|Total|Total of all reporting groups
233428|NCT01087541|B2|Baseline|Control Group|Usual healthcare of diabetics patients
233429|NCT01087541|B1|Baseline|Intervention|Behavioural program of education for health professionals of the study
233430|NCT01087541|P2|Participant Flow|Control Group|Usual healthcare of diabetics patients
233431|NCT01087541|P1|Participant Flow|Intervention|Behavioural program of education for health professionals of the study
233432|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233433|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233434|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233435|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233436|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233437|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233438|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233439|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233440|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233441|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233442|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
233443|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
233444|NCT01087541|E2|Reported Event|Control Group|Usual healthcare
233445|NCT01087541|E1|Reported Event|Intervention Group|Intervention group: educational program
233446|NCT01087528|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
233449|NCT01087528|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
233450|NCT01087502|B3|Baseline|Total|Total of all reporting groups
233451|NCT01087502|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233452|NCT01087502|B1|Baseline|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233453|NCT01087502|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233454|NCT01087502|P1|Participant Flow|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233455|NCT01087502|O1|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233456|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233457|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233458|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233459|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233460|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233461|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233462|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233463|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233464|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233465|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233466|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233467|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233468|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233469|NCT01087502|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233470|NCT01087502|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
233471|NCT01087502|E1|Reported Event|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
233472|NCT01087489|B1|Baseline|All Study Participants|Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
233473|NCT01087489|P2|Participant Flow|Unilateral|Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
233474|NCT01087489|P1|Participant Flow|Bilateral|Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.
233475|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
233476|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
233477|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
233478|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
233479|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
233480|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
233481|NCT01087489|E2|Reported Event|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
233530|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233482|NCT01087489|E1|Reported Event|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
233483|NCT01086969|B4|Baseline|Total|Total of all reporting groups
233484|NCT01086969|B3|Baseline|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233485|NCT01086969|B2|Baseline|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233486|NCT01086969|B1|Baseline|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233487|NCT01086969|P3|Participant Flow|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233488|NCT01086969|P2|Participant Flow|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233489|NCT01086969|P1|Participant Flow|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233490|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233491|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233492|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233493|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233494|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233495|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233496|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233497|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233498|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233499|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233500|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233501|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233502|NCT01086969|E3|Reported Event|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
233503|NCT01086969|E2|Reported Event|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
233504|NCT01086969|E1|Reported Event|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
233505|NCT01086852|B1|Baseline|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233506|NCT01086852|P1|Participant Flow|Active Treatment With FACTOR X|Four subjects underwent 4 major surgeries with active treatment (FACTOR X)
233507|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233508|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233509|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233510|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233511|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233512|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
233513|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
233514|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
233515|NCT01086852|E1|Reported Event|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
233516|NCT01086761|B6|Baseline|Total|Total of all reporting groups
233517|NCT01086761|B5|Baseline|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233518|NCT01086761|B4|Baseline|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233519|NCT01086761|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233520|NCT01086761|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233521|NCT01086761|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233522|NCT01086761|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
233523|NCT01086761|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233524|NCT01086761|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233525|NCT01086761|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233526|NCT01086761|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233527|NCT01086761|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233528|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233529|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233542|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233543|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233544|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233545|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233546|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233547|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233548|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233549|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233550|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233551|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233552|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233553|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233554|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233555|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233556|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233557|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233558|NCT01086761|O1|Outcome|MP0112|Single intravitreal injection of MP0112 in the study eye of one of the following doses: 0.04 mg, 0.15 mg, 0.4 mg, 1.0 mg or 2.0 mg.
233559|NCT01086761|E5|Reported Event|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
233560|NCT01086761|E4|Reported Event|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
233561|NCT01086761|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
233562|NCT01086761|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
233563|NCT01086761|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
233564|NCT01086475|B3|Baseline|Total|Total of all reporting groups
233565|NCT01086475|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions~Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions"
233566|NCT01086475|B1|Baseline|D-cycloserine|"Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions~D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions"
233567|NCT01086475|P2|Participant Flow|Placebo|Subjects who received placebo
233568|NCT01086475|P1|Participant Flow|D-cycloserine|Subjects who received d-cycloserine
233569|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
233570|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
233571|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
233572|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
233573|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
233574|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
233575|NCT01086475|E2|Reported Event|Placebo|Subjects who received placebo
233576|NCT01086475|E1|Reported Event|D-cycloserine|Subjects who received d-cycloserine
233577|NCT01086410|B5|Baseline|Total|Total of all reporting groups
233578|NCT01086410|B4|Baseline|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233579|NCT01086410|B3|Baseline|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233580|NCT01086410|B2|Baseline|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233581|NCT01086410|B1|Baseline|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233582|NCT01086410|P4|Participant Flow|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233583|NCT01086410|P3|Participant Flow|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233698|NCT01086215|P3|Participant Flow|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233699|NCT01086215|P2|Participant Flow|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
246499|NCT01048593|E2|Reported Event|Dose 2|513ug dose group
233584|NCT01086410|P2|Participant Flow|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233585|NCT01086410|P1|Participant Flow|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233586|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233587|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233588|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233589|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233590|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233591|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233592|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233593|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233594|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233595|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233596|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233597|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233598|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233599|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233600|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233601|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233602|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233603|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233604|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233605|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233606|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233607|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233608|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233609|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233610|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233611|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233612|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233613|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233614|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233615|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233616|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233617|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233618|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233619|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
246500|NCT01048593|E1|Reported Event|Dose 1|114ug dose group
233620|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233621|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233622|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233623|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233624|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233625|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233626|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233627|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233628|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233629|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233630|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233631|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233632|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233633|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233634|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233635|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233636|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233637|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
247602|NCT01043705|B4|Baseline|Total|Total of all reporting groups
233638|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233639|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233640|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233641|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233642|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233643|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233644|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233645|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233646|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233647|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233648|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233649|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233650|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233651|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233652|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233653|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233654|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233655|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
247764|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
233656|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233657|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233658|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233659|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233660|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233661|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233662|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233663|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233664|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233665|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233666|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233667|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233668|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233669|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233670|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233671|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233672|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233673|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
248348|NCT01040780|O2|Outcome|Gefitinib|250 mg daily by mouth
233674|NCT01086410|E4|Reported Event|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
233675|NCT01086410|E3|Reported Event|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233676|NCT01086410|E2|Reported Event|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
233677|NCT01086410|E1|Reported Event|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
233678|NCT01086384|B3|Baseline|Total|Total of all reporting groups
233679|NCT01086384|B2|Baseline|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233680|NCT01086384|B1|Baseline|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233681|NCT01086384|P3|Participant Flow|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233682|NCT01086384|P2|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233683|NCT01086384|P1|Participant Flow|FP 250 µg/ICS|Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
233684|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233685|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233686|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233687|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233688|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233689|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233690|NCT01086384|E2|Reported Event|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233691|NCT01086384|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
233692|NCT01086215|B5|Baseline|Total|Total of all reporting groups
233693|NCT01086215|B4|Baseline|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233694|NCT01086215|B3|Baseline|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233695|NCT01086215|B2|Baseline|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
233696|NCT01086215|B1|Baseline|Limb Ischemia|Patients presenting with limb ischemia for treatment
233697|NCT01086215|P4|Participant Flow|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233700|NCT01086215|P1|Participant Flow|Limb Ischemia|Patients presenting with limb ischemia for treatment
233701|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233702|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233703|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
233704|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
233705|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233706|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233707|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
233708|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
233709|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233710|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233711|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
233712|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
233713|NCT01086215|E4|Reported Event|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
233714|NCT01086215|E3|Reported Event|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
233715|NCT01086215|E2|Reported Event|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
233716|NCT01086215|E1|Reported Event|Limb Ischemia|Patients presenting with limb ischemia for treatment
233717|NCT01086033|B1|Baseline|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233718|NCT01086033|P1|Participant Flow|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233719|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233720|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233721|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233722|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233723|NCT01086033|O3|Outcome|No Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
233724|NCT01086033|O2|Outcome|Moderate Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
233725|NCT01086033|O1|Outcome|Good Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
233726|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233727|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233728|NCT01086033|E1|Reported Event|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
233729|NCT01085968|B3|Baseline|Total|Total of all reporting groups
233730|NCT01085968|B2|Baseline|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233731|NCT01085968|B1|Baseline|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233732|NCT01085968|P2|Participant Flow|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233733|NCT01085968|P1|Participant Flow|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233734|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233735|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233736|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233737|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233991|NCT01085201|O4|Outcome|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233738|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233739|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233740|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233741|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233742|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233743|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233744|NCT01085968|E2|Reported Event|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233745|NCT01085968|E1|Reported Event|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
233746|NCT01085903|B3|Baseline|Total|Total of all reporting groups
233747|NCT01085903|B2|Baseline|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233748|NCT01085903|B1|Baseline|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
233749|NCT01085903|P3|Participant Flow|Stroke Subjects: Modafinil Then Placebo|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
233750|NCT01085903|P2|Participant Flow|Stroke Subjects: Placebo Then Modafinil|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
233751|NCT01085903|P1|Participant Flow|Normal Subjects Baseline|"Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
233752|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients"
233753|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233754|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
233755|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233756|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline and CPS conditions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
234065|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
233757|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233758|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233759|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
233760|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233761|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233762|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233763|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
233764|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
233765|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233766|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233767|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
233768|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
233769|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
233770|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233771|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
233772|NCT01085903|E2|Reported Event|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
233773|NCT01085903|E1|Reported Event|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
233774|NCT01085825|B3|Baseline|Total|Total of all reporting groups
233775|NCT01085825|B2|Baseline|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
235851|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
233776|NCT01085825|B1|Baseline|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233777|NCT01085825|P2|Participant Flow|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233778|NCT01085825|P1|Participant Flow|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233779|NCT01085825|O2|Outcome|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233780|NCT01085825|O1|Outcome|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233781|NCT01085825|E2|Reported Event|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233782|NCT01085825|E1|Reported Event|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
233783|NCT01085786|B3|Baseline|Total|Total of all reporting groups
233784|NCT01085786|B2|Baseline|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
233785|NCT01085786|B1|Baseline|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
233786|NCT01085786|P2|Participant Flow|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
233787|NCT01085786|P1|Participant Flow|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
233788|NCT01085786|O2|Outcome|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
233789|NCT01085786|O1|Outcome|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
233790|NCT01085786|E2|Reported Event|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
233791|NCT01085786|E1|Reported Event|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
233792|NCT01085760|B5|Baseline|Total|Total of all reporting groups
233793|NCT01085760|B4|Baseline|High Dose Metronidazole|metronidazole 500 mg 3 times a day
233794|NCT01085760|B3|Baseline|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233795|NCT01085760|B2|Baseline|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233796|NCT01085760|B1|Baseline|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233797|NCT01085760|P4|Participant Flow|High Dose Metronidazole|metronidazole 500 mg 3 times a day
233798|NCT01085760|P3|Participant Flow|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233799|NCT01085760|P2|Participant Flow|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233800|NCT01085760|P1|Participant Flow|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233801|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
233802|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233803|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233804|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233805|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
233806|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233807|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233808|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233809|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
233810|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233811|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233812|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233813|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
233814|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233815|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233816|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233817|NCT01085760|E4|Reported Event|High Dose Metronidazole|metronidazole 500 mg 3 times a day
233818|NCT01085760|E3|Reported Event|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
233819|NCT01085760|E2|Reported Event|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
233820|NCT01085760|E1|Reported Event|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
233821|NCT01085734|B3|Baseline|Total|Total of all reporting groups
233822|NCT01085734|B2|Baseline|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
233823|NCT01085734|B1|Baseline|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
233824|NCT01085734|P2|Participant Flow|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
233825|NCT01085734|P1|Participant Flow|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
233826|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
233827|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
233828|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
233829|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
233830|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
233831|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
233832|NCT01085734|E2|Reported Event|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
233833|NCT01085734|E1|Reported Event|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
233834|NCT01085682|B3|Baseline|Total|Total of all reporting groups
233835|NCT01085682|B2|Baseline|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
233836|NCT01085682|B1|Baseline|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
233837|NCT01085682|P2|Participant Flow|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
233838|NCT01085682|P1|Participant Flow|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
233839|NCT01085682|O2|Outcome|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
233840|NCT01085682|O1|Outcome|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
233841|NCT01085682|E2|Reported Event|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
233842|NCT01085682|E1|Reported Event|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
233843|NCT01085643|B1|Baseline|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233844|NCT01085643|P1|Participant Flow|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233845|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233846|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
234066|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
233847|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233848|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233849|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233850|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233851|NCT01085643|E1|Reported Event|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
233852|NCT01085591|B4|Baseline|Total|Total of all reporting groups
233853|NCT01085591|B3|Baseline|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233854|NCT01085591|B2|Baseline|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
233855|NCT01085591|B1|Baseline|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233856|NCT01085591|P3|Participant Flow|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233857|NCT01085591|P2|Participant Flow|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
233858|NCT01085591|P1|Participant Flow|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233859|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233860|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233861|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233862|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233863|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233864|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233865|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233866|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233867|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233868|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233869|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233870|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233871|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233872|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233873|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233874|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233875|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233876|NCT01085591|O1|Outcome|CB-183,315, 125mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233877|NCT01085591|E3|Reported Event|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
233878|NCT01085591|E2|Reported Event|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
233879|NCT01085591|E1|Reported Event|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
233880|NCT01085539|B1|Baseline|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
233881|NCT01085539|P1|Participant Flow|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
233882|NCT01085539|O1|Outcome|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
233883|NCT01085539|E1|Reported Event|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
233884|NCT01085513|B3|Baseline|Total|Total of all reporting groups
233885|NCT01085513|B2|Baseline|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
233886|NCT01085513|B1|Baseline|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
233887|NCT01085513|P2|Participant Flow|Healthy Volunteers|Healthy volunteers
233888|NCT01085513|P1|Participant Flow|Patients|Patients previously indicated for manometry
233889|NCT01085513|O2|Outcome|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
233890|NCT01085513|O1|Outcome|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
233891|NCT01085513|E2|Reported Event|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
233892|NCT01085513|E1|Reported Event|Patients|"Patients previously indicated for manometry~Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea.~In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days."
233893|NCT01085500|B3|Baseline|Total|Total of all reporting groups
233894|NCT01085500|B2|Baseline|Current Practice|General surgery residents will undergo training according to current practice.
233895|NCT01085500|B1|Baseline|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233896|NCT01085500|P2|Participant Flow|Current Practice|General surgery residents will undergo training according to current practice.
233897|NCT01085500|P1|Participant Flow|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233898|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
233899|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233900|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
233901|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233902|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
233903|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233904|NCT01085500|E2|Reported Event|Current Practice|General surgery residents will undergo training according to current practice.
233905|NCT01085500|E1|Reported Event|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
233906|NCT01085357|B3|Baseline|Total|Total of all reporting groups
233907|NCT01085357|B2|Baseline|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233908|NCT01085357|B1|Baseline|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233909|NCT01085357|P2|Participant Flow|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233910|NCT01085357|P1|Participant Flow|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233911|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233912|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233913|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233914|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233915|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233916|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233917|NCT01085357|E2|Reported Event|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
233918|NCT01085357|E1|Reported Event|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
233919|NCT01085331|B3|Baseline|Total|Total of all reporting groups
233992|NCT01085201|O3|Outcome|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233920|NCT01085331|B2|Baseline|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233921|NCT01085331|B1|Baseline|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233922|NCT01085331|P2|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; Irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233923|NCT01085331|P1|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 milligrams per day (mg/day) once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2.) at conventional doses on days 1 and 15 of the same 28 day cycle.
233924|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233925|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233926|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233927|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233928|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233929|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233930|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233931|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233993|NCT01085201|O2|Outcome|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233994|NCT01085201|O1|Outcome|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234125|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
233932|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233933|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233934|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233935|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233936|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233937|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233938|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233939|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233940|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233941|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233942|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233943|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233995|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233996|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233944|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233945|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233946|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233947|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233948|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233949|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233950|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233951|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233952|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233953|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233954|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo +FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233955|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233997|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233998|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233956|NCT01085331|O1|Outcome|Pimasertib+FOLFIRI (Overall)|Pimasertib was administered orally once daily 45 mg/day and 60 mg/day on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233957|NCT01085331|E2|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233958|NCT01085331|E1|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
233959|NCT01085318|B3|Baseline|Total|Total of all reporting groups
233960|NCT01085318|B2|Baseline|Arm 2 Healthy Control|Healthy Control
233961|NCT01085318|B1|Baseline|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233962|NCT01085318|P2|Participant Flow|Arm 2 Healthy Control|Healthy Control
233963|NCT01085318|P1|Participant Flow|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233964|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233965|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233966|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
233967|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233968|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
233969|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233970|NCT01085318|E2|Reported Event|Arm 2 Healthy Control|Healthy Control
233971|NCT01085318|E1|Reported Event|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
233972|NCT01085214|B1|Baseline|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233973|NCT01085214|P1|Participant Flow|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233974|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233975|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233976|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233977|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233978|NCT01085214|E1|Reported Event|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
233979|NCT01085201|B6|Baseline|Total|Total of all reporting groups
233980|NCT01085201|B5|Baseline|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233981|NCT01085201|B4|Baseline|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233982|NCT01085201|B3|Baseline|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233983|NCT01085201|B2|Baseline|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233984|NCT01085201|B1|Baseline|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233985|NCT01085201|P5|Participant Flow|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233986|NCT01085201|P4|Participant Flow|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233987|NCT01085201|P3|Participant Flow|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233988|NCT01085201|P2|Participant Flow|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233989|NCT01085201|P1|Participant Flow|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
233990|NCT01085201|O5|Outcome|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
249262|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
233999|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234000|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234001|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234002|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234003|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234004|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234005|NCT01085201|E5|Reported Event|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234006|NCT01085201|E4|Reported Event|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234007|NCT01085201|E3|Reported Event|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234008|NCT01085201|E2|Reported Event|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234009|NCT01085201|E1|Reported Event|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
234010|NCT01085136|B1|Baseline|Part A: Afatinib Monotherapy|Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral
234011|NCT01085136|P3|Participant Flow|Investigators Choice of Chemotherapy|Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule
234012|NCT01085136|P2|Participant Flow|Afatinib Plus Paclitaxel|"Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous"
234013|NCT01085136|P1|Participant Flow|Afatinib Monotherapy|Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral
234014|NCT01085136|O1|Outcome|Afatinib Monotherapy|Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral
234015|NCT01085136|O2|Outcome|Part B:Investigators Choice of Chemotherapy|Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule
234016|NCT01085136|O1|Outcome|Part B: Afatinib Plus Paclitaxel|"Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous"
234017|NCT01085136|O2|Outcome|Part B:Investigators Choice of Chemotherapy|Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule
234018|NCT01085136|O1|Outcome|Part B: Afatinib Plus Paclitaxel|"Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous"
234019|NCT01085136|O1|Outcome|Afatinib Monotherapy|Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral
234020|NCT01085136|O2|Outcome|Part B:Investigators Choice of Chemotherapy|Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule
234021|NCT01085136|O1|Outcome|Part B: Afatinib Plus Paclitaxel|"Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous"
234063|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234022|NCT01085136|E3|Reported Event|Part B:Investigators Choice of Chemotherapy|"Reference therapy for Part B:Investigators choice of chemotherapy dose: Depending on schedule (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous or oral, depending on schedule.~Median duration of exposure was 50.5 days."
234023|NCT01085136|E2|Reported Event|Part B: Afatinib Plus Paclitaxel|"Test product for Part B: Afatinib film-coated tablet dose: 40 mg/day, with dose reductions to 30 mg/day and 20 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Concomitant therapy for Part B:Paclitaxel dose: 80 mg/m2 once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol-defined dose reduction scheme and the current local summary of product characteristics) mode of admin.: Intravenous~Median duration of exposure was 132.5 days."
234024|NCT01085136|E1|Reported Event|Part A: Afatinib Monotherapy|"Test product for Part A: Afatinib film-coated tablet dose: 50 mg/day, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme) mode of admin.: Oral~Median duration of exposure was 86.0 days."
234025|NCT01085006|B3|Baseline|Total|Total of all reporting groups
234026|NCT01085006|B2|Baseline|Normal Saline Infusion|
234027|NCT01085006|B1|Baseline|Tranexamic Acid|
234028|NCT01085006|P2|Participant Flow|Normal Saline Infusion|
234029|NCT01085006|P1|Participant Flow|Tranexamic Acid|
234030|NCT01085006|O2|Outcome|Normal Saline Infusion|
234031|NCT01085006|O1|Outcome|Tranexamic Acid|
234032|NCT01085006|E2|Reported Event|Normal Saline Infusion|
234033|NCT01085006|E1|Reported Event|Tranexamic Acid|
234034|NCT01084759|B1|Baseline|Etoposide and Testosterone|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
234035|NCT01084759|P1|Participant Flow|Testosterone|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
234036|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
234037|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
234038|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
234039|NCT01084759|E1|Reported Event|Treatment Group|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
234040|NCT01084707|B1|Baseline|All Randomized Subjects|All subjects randomized into the trial, e.g., Full Analysis Set
234041|NCT01084707|P1|Participant Flow|Overall Study|All subjects randomized into the trial
234042|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234043|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
234044|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
234045|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234046|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234047|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234048|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234049|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234050|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
234051|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
234052|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234053|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234054|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234055|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
234056|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
234057|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234058|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234059|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234060|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
234061|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
234062|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234064|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234067|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234068|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234069|NCT01084707|E5|Reported Event|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
234070|NCT01084707|E4|Reported Event|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
234071|NCT01084707|E3|Reported Event|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
234072|NCT01084707|E2|Reported Event|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
234073|NCT01084707|E1|Reported Event|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
234074|NCT01084668|B1|Baseline|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
234075|NCT01084668|P1|Participant Flow|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
234076|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
234077|NCT01084668|O2|Outcome|Subgroup With Nail Psoriasis|Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
234078|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
234079|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
234080|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
234081|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
234082|NCT01084668|E1|Reported Event|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
234083|NCT01084603|B1|Baseline|Overall Study|Full Safety Set
234084|NCT01084603|P1|Participant Flow|Overall Study|Full Safety Set
234085|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234086|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234087|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
234088|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
234089|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
234090|NCT01084603|O1|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234091|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234092|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234093|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
234094|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
234095|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
234096|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234097|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234098|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
234099|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
234100|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
234101|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234102|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234103|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
234104|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
234105|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
234106|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234107|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234108|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
234109|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
234110|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
234111|NCT01084603|E5|Reported Event|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
234112|NCT01084603|E4|Reported Event|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
234113|NCT01084603|E3|Reported Event|Oral Nicotine 4|4 administrations of 1 mg
234114|NCT01084603|E2|Reported Event|Oral Nicotine 2|2 administrations of 1 mg
234115|NCT01084603|E1|Reported Event|Oral Nicotine 1|1 administration of 1 mg
234116|NCT01084551|B4|Baseline|Total|Total of all reporting groups
234117|NCT01084551|B3|Baseline|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234118|NCT01084551|B2|Baseline|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234119|NCT01084551|B1|Baseline|Placebo|0 mg/day for 13 weeks
234120|NCT01084551|P3|Participant Flow|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234121|NCT01084551|P2|Participant Flow|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234122|NCT01084551|P1|Participant Flow|Placebo|0 mg/day for 13 weeks
234123|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234124|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234126|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234127|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234128|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234129|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234130|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234131|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234132|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234133|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234134|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234135|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234136|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234137|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234138|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234139|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234140|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234141|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234142|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234143|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234144|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234145|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234146|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234147|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234148|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234149|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234150|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234151|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234152|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234153|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234154|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234155|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
234156|NCT01084551|E3|Reported Event|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
234157|NCT01084551|E2|Reported Event|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
234158|NCT01084551|E1|Reported Event|Placebo|0 mg/day for 13 weeks
234159|NCT01084538|B1|Baseline|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234160|NCT01084538|P1|Participant Flow|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234161|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234162|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234163|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234164|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234205|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234165|NCT01084538|E1|Reported Event|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
234166|NCT01084278|B6|Baseline|Total|Total of all reporting groups
234167|NCT01084278|B5|Baseline|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234168|NCT01084278|B4|Baseline|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234169|NCT01084278|B3|Baseline|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234170|NCT01084278|B2|Baseline|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234171|NCT01084278|B1|Baseline|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234172|NCT01084278|P5|Participant Flow|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234173|NCT01084278|P4|Participant Flow|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234174|NCT01084278|P3|Participant Flow|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234175|NCT01084278|P2|Participant Flow|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234176|NCT01084278|P1|Participant Flow|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234177|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234178|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234179|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234180|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234181|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234182|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234183|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234184|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234185|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234186|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234187|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234188|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234189|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234190|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234191|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234192|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234193|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234194|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234195|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234196|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234197|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234198|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234199|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234200|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234201|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234202|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234203|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234204|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234206|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234207|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234208|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234209|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234210|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234211|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234212|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234213|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234214|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234215|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234216|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234217|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234218|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234219|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234220|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234221|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234222|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234223|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234224|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234225|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234226|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234227|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234228|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234229|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234230|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234231|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234232|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234233|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234234|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234235|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234236|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234237|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234238|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234239|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234240|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234241|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234242|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234243|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234244|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234245|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234246|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
234247|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
234248|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
234249|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
234250|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
234669|NCT01083186|O1|Outcome|Participants Within the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
234251|NCT01084278|E5|Reported Event|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
234252|NCT01084278|E4|Reported Event|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234253|NCT01084278|E3|Reported Event|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234254|NCT01084278|E2|Reported Event|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234255|NCT01084278|E1|Reported Event|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
234256|NCT01084265|B1|Baseline|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234257|NCT01084265|P1|Participant Flow|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234258|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234259|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234260|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234261|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234262|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234263|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234264|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234265|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234266|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234267|NCT01084265|E1|Reported Event|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
234268|NCT01084239|B3|Baseline|Total|Total of all reporting groups
234269|NCT01084239|B2|Baseline|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234270|NCT01084239|B1|Baseline|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234271|NCT01084239|P2|Participant Flow|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234847|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234272|NCT01084239|P1|Participant Flow|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234273|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234274|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234275|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234276|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234277|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234278|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234279|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234280|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234281|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234282|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234283|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234284|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234285|NCT01084239|E2|Reported Event|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
234286|NCT01084239|E1|Reported Event|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
234287|NCT01084148|B3|Baseline|Total|Total of all reporting groups
234288|NCT01084148|B2|Baseline|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
234289|NCT01084148|B1|Baseline|V0034CR01B|"cream~V0034CR01B"
234290|NCT01084148|P2|Participant Flow|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
234291|NCT01084148|P1|Participant Flow|V0034CR01B|"cream~V0034CR01B"
234292|NCT01084148|O2|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
234293|NCT01084148|O1|Outcome|V0034CR01B|"cream~V0034CR01B"
234294|NCT01084148|E2|Reported Event|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
234295|NCT01084148|E1|Reported Event|V0034CR01B|"cream~V0034CR01B"
234296|NCT01084135|B5|Baseline|Total|Total of all reporting groups
234297|NCT01084135|B4|Baseline|12 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
234298|NCT01084135|B3|Baseline|12 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
234299|NCT01084135|B2|Baseline|20 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
234300|NCT01084135|B1|Baseline|20 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
234301|NCT01084135|P2|Participant Flow|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
234302|NCT01084135|P1|Participant Flow|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
234303|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
234304|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
234305|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
234306|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
234307|NCT01084135|E4|Reported Event|12 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
234308|NCT01084135|E3|Reported Event|12 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
234309|NCT01084135|E2|Reported Event|20 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
234310|NCT01084135|E1|Reported Event|20 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
234311|NCT01084083|B1|Baseline|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
234312|NCT01084083|P1|Participant Flow|Overall|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
234313|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
234314|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
234315|NCT01084083|O1|Outcome|Primary Study Population|The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
234316|NCT01084083|E1|Reported Event|All Treated Patients|"Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.~Adverse events data were reported for all patients received at least one dose of protocol therapy."
234317|NCT01084005|B3|Baseline|Total|Total of all reporting groups
234318|NCT01084005|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234319|NCT01084005|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
234320|NCT01084005|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234321|NCT01084005|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
234322|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234323|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234324|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234325|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234326|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234327|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234328|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234329|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234330|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234331|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234332|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234333|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234334|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234335|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234336|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234337|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234338|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234339|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234340|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234341|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234342|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234343|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234344|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234345|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
234346|NCT01084005|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
234347|NCT01084005|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
234348|NCT01083979|B1|Baseline|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
234349|NCT01083979|P1|Participant Flow|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
234350|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
234351|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
234352|NCT01083979|E1|Reported Event|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
234353|NCT01083901|B4|Baseline|Total|Total of all reporting groups
234354|NCT01083901|B3|Baseline|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
234355|NCT01083901|B2|Baseline|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
234609|NCT01083485|P1|Participant Flow|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234356|NCT01083901|B1|Baseline|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
234357|NCT01083901|P3|Participant Flow|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
234358|NCT01083901|P2|Participant Flow|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
234359|NCT01083901|P1|Participant Flow|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
234360|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
234361|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
234362|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
234363|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
234364|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
234365|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
234366|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
234367|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
234368|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
234369|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
234370|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
234371|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
234372|NCT01083901|E3|Reported Event|Placebo and Resistance Exercise Training|
234373|NCT01083901|E2|Reported Event|Ibuprofen and Resistance Exercise Traininig|
234374|NCT01083901|E1|Reported Event|Acetaminophen and Resistance Exercise Training|
234375|NCT01083849|B3|Baseline|Total|Total of all reporting groups
234376|NCT01083849|B2|Baseline|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234377|NCT01083849|B1|Baseline|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234378|NCT01083849|P2|Participant Flow|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234379|NCT01083849|P1|Participant Flow|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234380|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234381|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234382|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234383|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234384|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234385|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234386|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234387|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234388|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234389|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234390|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
249263|NCT01037244|O4|Outcome|Placebo|Placebo tablets
234391|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234392|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234393|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
234394|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
234395|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234396|NCT01083849|E2|Reported Event|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234397|NCT01083849|E1|Reported Event|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
234398|NCT01083810|B4|Baseline|Total|Total of all reporting groups
234399|NCT01083810|B3|Baseline|Non-B|Participants infected with non-B subtypes of HIV-1.
234400|NCT01083810|B2|Baseline|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234401|NCT01083810|B1|Baseline|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234402|NCT01083810|P3|Participant Flow|Non-B|Participants infected with non-B subtypes of HIV-1.
234403|NCT01083810|P2|Participant Flow|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234404|NCT01083810|P1|Participant Flow|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234405|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234406|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234407|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234408|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234409|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234410|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234411|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234412|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234413|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234414|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234415|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234416|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234417|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234418|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234419|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234420|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
234421|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
234422|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
234423|NCT01083810|E1|Reported Event|HIV-infected Patients|Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
234424|NCT01083771|B1|Baseline|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
234425|NCT01083771|P1|Participant Flow|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
234426|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
234427|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
234428|NCT01083771|E1|Reported Event|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
234429|NCT01083758|B1|Baseline|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234430|NCT01083758|P1|Participant Flow|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234431|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234432|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234433|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234434|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234435|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234436|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234437|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234438|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234439|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234440|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234441|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234442|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234443|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234444|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234445|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234446|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234447|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234448|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234449|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234450|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234451|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234452|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234453|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234454|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234455|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234456|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234457|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234458|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234524|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234459|NCT01083758|E1|Reported Event|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
234460|NCT01083732|B4|Baseline|Total|Total of all reporting groups
234461|NCT01083732|B3|Baseline|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234462|NCT01083732|B2|Baseline|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234463|NCT01083732|B1|Baseline|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234464|NCT01083732|P3|Participant Flow|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234465|NCT01083732|P2|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234466|NCT01083732|P1|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234467|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234468|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234469|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234470|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234471|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234472|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234473|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234474|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234475|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234476|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234477|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234478|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234479|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234610|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234480|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234481|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234482|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234483|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234484|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234485|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234486|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234487|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234488|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234489|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234490|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234491|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
234492|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234493|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234494|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234495|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234496|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234497|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234498|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234499|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234525|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
249264|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
234500|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234501|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234502|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234503|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234504|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234505|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234506|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234507|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234508|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234509|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234510|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234511|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234512|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234513|NCT01083732|E3|Reported Event|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234514|NCT01083732|E2|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234515|NCT01083732|E1|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
234516|NCT01083693|B4|Baseline|Total|Total of all reporting groups
234517|NCT01083693|B3|Baseline|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234518|NCT01083693|B2|Baseline|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234519|NCT01083693|B1|Baseline|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234520|NCT01083693|P3|Participant Flow|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234521|NCT01083693|P2|Participant Flow|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234522|NCT01083693|P1|Participant Flow|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234523|NCT01083693|O4|Outcome|Total|
234526|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234527|NCT01083693|O4|Outcome|Total|
234528|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234529|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234530|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234531|NCT01083693|O3|Outcome|Total|
234532|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234533|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234534|NCT01083693|O3|Outcome|Total|
234535|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234536|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234537|NCT01083693|O1|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234538|NCT01083693|O3|Outcome|Total|
234539|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234540|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234541|NCT01083693|O4|Outcome|Total|
234542|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234543|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234544|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234545|NCT01083693|O4|Outcome|Total|
234546|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234547|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234548|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234549|NCT01083693|O3|Outcome|Total|
234550|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234551|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234552|NCT01083693|E4|Reported Event|Total|
234553|NCT01083693|E3|Reported Event|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
234554|NCT01083693|E2|Reported Event|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234555|NCT01083693|E1|Reported Event|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
234556|NCT01083654|B3|Baseline|Total|Total of all reporting groups
234557|NCT01083654|B2|Baseline|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)"
234567|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234568|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234569|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234558|NCT01083654|B1|Baseline|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling."
234559|NCT01083654|P2|Participant Flow|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
234560|NCT01083654|P1|Participant Flow|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
234561|NCT01083654|O2|Outcome|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
234562|NCT01083654|O1|Outcome|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
234563|NCT01083654|E2|Reported Event|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
234564|NCT01083654|E1|Reported Event|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
234565|NCT01083602|B1|Baseline|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234566|NCT01083602|P1|Participant Flow|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
249265|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
234570|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234571|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234572|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
234573|NCT01083602|E1|Reported Event|PAN + BTZ + Dex|PAN + BTZ + Dex
234574|NCT01083576|B3|Baseline|Total|Total of all reporting groups
234575|NCT01083576|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234576|NCT01083576|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234577|NCT01083576|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234578|NCT01083576|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
234579|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234580|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
234581|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234582|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
234583|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234584|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234585|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234586|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234587|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234588|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234589|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234590|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234591|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234592|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234593|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234594|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234595|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234596|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
234597|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234598|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234599|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234600|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234601|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234602|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234603|NCT01083576|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234604|NCT01083576|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
234605|NCT01083485|B3|Baseline|Total|Total of all reporting groups
234606|NCT01083485|B2|Baseline|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234607|NCT01083485|B1|Baseline|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234608|NCT01083485|P2|Participant Flow|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
235852|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
234611|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234612|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.1
234613|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.4
234614|NCT01083485|E2|Reported Event|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234615|NCT01083485|E1|Reported Event|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
234616|NCT01083472|B3|Baseline|Total|Total of all reporting groups
234617|NCT01083472|B2|Baseline|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
234618|NCT01083472|B1|Baseline|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
234619|NCT01083472|P2|Participant Flow|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
234620|NCT01083472|P1|Participant Flow|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
234621|NCT01083472|O2|Outcome|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
234622|NCT01083472|O1|Outcome|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
234623|NCT01083472|E2|Reported Event|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
234624|NCT01083472|E1|Reported Event|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
234625|NCT01083316|B1|Baseline|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234626|NCT01083316|P1|Participant Flow|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234627|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234628|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234629|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234630|NCT01083316|E1|Reported Event|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
234631|NCT01083199|B1|Baseline|AMS CONTINUUM™ Device|
234632|NCT01083199|P1|Participant Flow|AMS CONTINUUM™ Device|
234633|NCT01083199|O1|Outcome|AMS CONTINUUM™ Device|
234634|NCT01083199|O1|Outcome|Continuum Device|
234635|NCT01083199|E1|Reported Event|AMS CONTINUUM™ Device|
234636|NCT01083186|B1|Baseline|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234637|NCT01083186|P1|Participant Flow|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234638|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234639|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234640|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234641|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234642|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234643|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234644|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234645|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234646|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234647|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234648|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234649|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234650|NCT01083186|O4|Outcome|CKD Stage 5|Participants with chronic kidney disease stage 5 (eGFR <15 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234651|NCT01083186|O3|Outcome|CKD Stage 4|Participants with chronic kidney disease stage 4 (eGFR 15-29 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234652|NCT01083186|O2|Outcome|CKD Stage 3|Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234653|NCT01083186|O1|Outcome|CKD Stage 2|Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234654|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234655|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234656|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 12"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
234657|NCT01083186|O4|Outcome|"++ Albuminuria at Month 12"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
234658|NCT01083186|O3|Outcome|"+ Albuminuria at Month 12"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
234659|NCT01083186|O2|Outcome|Trace Albuminuria at Month 12|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
234660|NCT01083186|O1|Outcome|No Albuminuria at Month 12|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
234661|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 6"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
234662|NCT01083186|O4|Outcome|"++ Albuminuria at Month 6"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
234663|NCT01083186|O3|Outcome|"+ Albuminuria at Month 6"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
234664|NCT01083186|O2|Outcome|Trace Albuminuria at Month 6|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
234665|NCT01083186|O1|Outcome|No Albuminuria at Month 6|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
234666|NCT01083186|O2|Outcome|Participants Outside of the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
234667|NCT01083186|O1|Outcome|Participants Within the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
234668|NCT01083186|O2|Outcome|Participants Outside of the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
234670|NCT01083186|O2|Outcome|Participants Out of the iPTH Target Range|Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
234671|NCT01083186|O1|Outcome|Participants Within the iPTH Target Range|Number of participants with iPTH levels within the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
234672|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234673|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234674|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234675|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234676|NCT01083186|E1|Reported Event|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
234677|NCT01083173|B1|Baseline|Overall Study|The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
234678|NCT01083173|P2|Participant Flow|Long-term Surveillance|The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
234679|NCT01083173|P1|Participant Flow|Main Surveillance|The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
234680|NCT01083173|O1|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
234681|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
234682|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
234683|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
234684|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
234685|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
234686|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
234687|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
234688|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
234689|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
234690|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
234691|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
234692|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
234693|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
234694|NCT01083173|E2|Reported Event|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
234695|NCT01083173|E1|Reported Event|Main Surveillance|All participants who received at least one dose of Kaletra
234696|NCT01083160|B1|Baseline|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234697|NCT01083160|P1|Participant Flow|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234698|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234699|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234700|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234701|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234702|NCT01083160|E1|Reported Event|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
234703|NCT01083121|B1|Baseline|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234704|NCT01083121|P1|Participant Flow|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234848|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234705|NCT01083121|O4|Outcome|Crohn's Disease|Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234706|NCT01083121|O3|Outcome|Ankylosing Spondylitis|Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234707|NCT01083121|O2|Outcome|Psoriatic Arthritis|Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234708|NCT01083121|O1|Outcome|Rheumatoid Arthritis|Participants with moderately to severely active rheumatoid arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234709|NCT01083121|O1|Outcome|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234710|NCT01083121|E1|Reported Event|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
234711|NCT01082965|B3|Baseline|Total|Total of all reporting groups
234712|NCT01082965|B2|Baseline|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234713|NCT01082965|B1|Baseline|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234714|NCT01082965|P2|Participant Flow|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234715|NCT01082965|P1|Participant Flow|Donepezil|Donepezil 5 milligram (mg) tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234716|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234717|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234718|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234719|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234720|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234721|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234722|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234723|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234724|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234725|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234726|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234727|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234728|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234729|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234730|NCT01082965|E2|Reported Event|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
234731|NCT01082965|E1|Reported Event|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
234732|NCT01082952|B3|Baseline|Total|Total of all reporting groups
234733|NCT01082952|B2|Baseline|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
234734|NCT01082952|B1|Baseline|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
234735|NCT01082952|P2|Participant Flow|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
234736|NCT01082952|P1|Participant Flow|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
234737|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
234738|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
234739|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
234740|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
234741|NCT01082952|E2|Reported Event|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
234742|NCT01082952|E1|Reported Event|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
234743|NCT01082939|B1|Baseline|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
234744|NCT01082939|P1|Participant Flow|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
234849|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234850|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234745|NCT01082939|O1|Outcome|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
234746|NCT01082939|E1|Reported Event|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
234747|NCT01082874|B5|Baseline|Total|Total of all reporting groups
234748|NCT01082874|B4|Baseline|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234749|NCT01082874|B3|Baseline|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234750|NCT01082874|B2|Baseline|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234751|NCT01082874|B1|Baseline|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234752|NCT01082874|P4|Participant Flow|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234753|NCT01082874|P3|Participant Flow|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234754|NCT01082874|P2|Participant Flow|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234755|NCT01082874|P1|Participant Flow|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234756|NCT01082874|O4|Outcome|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234757|NCT01082874|O3|Outcome|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234758|NCT01082874|O2|Outcome|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234759|NCT01082874|O1|Outcome|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234760|NCT01082874|E4|Reported Event|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234761|NCT01082874|E3|Reported Event|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234851|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234852|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234762|NCT01082874|E2|Reported Event|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234763|NCT01082874|E1|Reported Event|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
234764|NCT01082640|B4|Baseline|Total|Total of all reporting groups
234765|NCT01082640|B3|Baseline|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234766|NCT01082640|B2|Baseline|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234767|NCT01082640|B1|Baseline|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234768|NCT01082640|P3|Participant Flow|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234769|NCT01082640|P2|Participant Flow|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234770|NCT01082640|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234771|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
234772|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
234773|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234774|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
234775|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
234776|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234777|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234778|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234779|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234780|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234781|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234782|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234783|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234784|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234785|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234786|NCT01082640|E3|Reported Event|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
234787|NCT01082640|E2|Reported Event|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
234788|NCT01082640|E1|Reported Event|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
234789|NCT01082614|B3|Baseline|Total|Total of all reporting groups
234790|NCT01082614|B2|Baseline|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
234791|NCT01082614|B1|Baseline|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
234792|NCT01082614|P2|Participant Flow|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
234793|NCT01082614|P1|Participant Flow|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
234853|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
249266|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
234794|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
234795|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
234796|NCT01082614|E2|Reported Event|Goal Directed Therapy|
234797|NCT01082614|E1|Reported Event|Standard Fluid Management|
234798|NCT01082588|B3|Baseline|Total|Total of all reporting groups
234799|NCT01082588|B2|Baseline|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234800|NCT01082588|B1|Baseline|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234801|NCT01082588|P2|Participant Flow|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234802|NCT01082588|P1|Participant Flow|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234803|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234804|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234805|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234806|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234807|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234808|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234809|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234810|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234811|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234812|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234813|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234814|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234815|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234816|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
234817|NCT01082588|E2|Reported Event|Placebo|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
234818|NCT01082588|E1|Reported Event|Pravastatin|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
234819|NCT01082575|B1|Baseline|Major Surgery|Post Operative patients
234820|NCT01082575|P1|Participant Flow|Major Surgery|Post Operative patients
234821|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
234822|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
234823|NCT01082575|E1|Reported Event|Major Surgery|Post Operative patients
234824|NCT01082380|B1|Baseline|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234825|NCT01082380|P1|Participant Flow|PF-02341066 250 mg|Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14[14C].
234826|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234827|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234828|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234829|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234830|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234831|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234832|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234833|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234834|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234835|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234836|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234837|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234838|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234839|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234840|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234841|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234842|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234843|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234844|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234845|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234846|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234854|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234855|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234856|NCT01082380|E1|Reported Event|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
234857|NCT01082367|B3|Baseline|Total|Total of all reporting groups
234858|NCT01082367|B2|Baseline|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234859|NCT01082367|B1|Baseline|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234860|NCT01082367|P2|Participant Flow|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234861|NCT01082367|P1|Participant Flow|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234862|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234863|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234864|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234865|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234866|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234867|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
234868|NCT01082367|E6|Reported Event|Off-treatment (Follow-up)|Off-treatment (follow-up)
234869|NCT01082367|E5|Reported Event|OL TOBI (Follow-up)|OL TOBI (follow-up)
234870|NCT01082367|E4|Reported Event|Off-treatment (Core)|Off-treatment (core)
234871|NCT01082367|E3|Reported Event|OL TOBI (Core)|OL TOBI (core)
234872|NCT01082367|E2|Reported Event|DB Placebo|DB Placebo
234873|NCT01082367|E1|Reported Event|DB TOBI|DB TOBI
234874|NCT01082328|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234875|NCT01082328|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234876|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234877|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234878|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234879|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234880|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234881|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234882|NCT01082328|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
234883|NCT01082159|B1|Baseline|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
234884|NCT01082159|P1|Participant Flow|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
234885|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
234886|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous lumbar decompression using the mild Device Kit.
234887|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
234888|NCT01082159|E1|Reported Event|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
234889|NCT01082081|B4|Baseline|Total|Total of all reporting groups
234890|NCT01082081|B3|Baseline|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234891|NCT01082081|B2|Baseline|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234892|NCT01082081|B1|Baseline|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234893|NCT01082081|P3|Participant Flow|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234894|NCT01082081|P2|Participant Flow|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234895|NCT01082081|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
234896|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234897|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234898|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234899|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234900|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234901|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234902|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234903|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234904|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234905|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234906|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234907|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234908|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234909|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234910|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234911|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234912|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234913|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234914|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234915|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234916|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234917|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234918|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234919|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234920|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234921|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234922|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234923|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234924|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234925|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234926|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234927|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234928|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234929|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234930|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234931|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234932|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234933|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234934|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234935|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234936|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234937|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234938|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234939|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234940|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234941|NCT01082081|E3|Reported Event|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
234973|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
234942|NCT01082081|E2|Reported Event|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
234943|NCT01082081|E1|Reported Event|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
234944|NCT01081951|B3|Baseline|Total|Total of all reporting groups
234945|NCT01081951|B2|Baseline|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234946|NCT01081951|B1|Baseline|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234947|NCT01081951|P2|Participant Flow|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234948|NCT01081951|P1|Participant Flow|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234949|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234950|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234951|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234952|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234953|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234954|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234955|NCT01081951|E2|Reported Event|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
234956|NCT01081951|E1|Reported Event|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
234957|NCT01081912|B1|Baseline|Open-label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)
234958|NCT01081912|P3|Participant Flow|Double-Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
234959|NCT01081912|P2|Participant Flow|Double-Blind Treatment Phase|"Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
234960|NCT01081912|P1|Participant Flow|Conversion/Titration Phase - Open-Label|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
234961|NCT01081912|O2|Outcome|Placebo Comparator|Placebo: Capsules, no active substance, shells identical to active comparator capsules
234962|NCT01081912|O1|Outcome|Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
234963|NCT01081912|E3|Reported Event|Double Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
234964|NCT01081912|E2|Reported Event|Double Blind Treatment Phase: Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
234965|NCT01081912|E1|Reported Event|Open-Label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
234966|NCT01081886|B3|Baseline|Total|Total of all reporting groups
234967|NCT01081886|B2|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
234968|NCT01081886|B1|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
234969|NCT01081886|P2|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
234970|NCT01081886|P1|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
234971|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
234972|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
249267|NCT01037244|O4|Outcome|Placebo|Placebo tablets
234974|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
234975|NCT01081886|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
234976|NCT01081886|E1|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
234977|NCT01081873|B1|Baseline|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
234978|NCT01081873|P1|Participant Flow|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234979|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234980|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234981|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234982|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234983|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234984|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants - MRI|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI.
234985|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants - Echograph|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via an echograph (hyperechogenic zones).
234986|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants - Prostate Biopsy|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via a prostate biopsy.
234987|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants - Rectal Examination|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via rectal examination.
234988|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234989|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
234990|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234991|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234992|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234993|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
234994|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Use at Any Visit|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit.
234995|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
234996|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
234997|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
234998|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
235099|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
234999|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
235000|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
235001|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
235002|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
235003|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
235004|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
235005|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
235006|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
235007|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
235008|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
235009|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
235010|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
235011|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
235012|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
235013|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
235014|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
235015|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
235016|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
235017|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
235018|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
235019|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
235020|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
235021|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
235022|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
235023|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
235024|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
235194|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235025|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
235026|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
235027|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
235028|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
235029|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
235030|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
235031|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
235032|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
235033|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
235034|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
235035|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
235036|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
235037|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
235038|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
235039|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
235040|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
235041|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
235042|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
235043|NCT01081873|E1|Reported Event|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
235044|NCT01081834|B6|Baseline|Total|Total of all reporting groups
235045|NCT01081834|B5|Baseline|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
235046|NCT01081834|B4|Baseline|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235047|NCT01081834|B3|Baseline|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
235048|NCT01081834|B2|Baseline|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235049|NCT01081834|B1|Baseline|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235050|NCT01081834|P5|Participant Flow|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
235051|NCT01081834|P4|Participant Flow|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
235052|NCT01081834|P3|Participant Flow|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
235053|NCT01081834|P2|Participant Flow|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235100|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235054|NCT01081834|P1|Participant Flow|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235055|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235056|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235057|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235058|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235059|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235060|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235061|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235062|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235063|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235064|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235065|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235066|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235067|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235068|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235069|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235070|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235071|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235072|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235073|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235074|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235075|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
235076|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235077|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235078|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235079|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235080|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235081|NCT01081834|O1|Outcome|Placebo|In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235082|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235083|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235084|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235085|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235086|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235087|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235088|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235089|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235090|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235091|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235092|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235093|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235094|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
235095|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235096|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235097|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
235098|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
235101|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
235102|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
235103|NCT01081834|E8|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
235104|NCT01081834|E7|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
235105|NCT01081834|E6|Reported Event|Main Study (Baseline to Week 52): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
235106|NCT01081834|E5|Reported Event|Main Study (Baseline to Week 52): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
235107|NCT01081834|E4|Reported Event|Main Study (Baseline to Week 52): Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.
235108|NCT01081834|E3|Reported Event|Main Study (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
235109|NCT01081834|E2|Reported Event|Main Study (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
235110|NCT01081834|E1|Reported Event|Main Study (Baseline to Week 26): Placebo|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.
235111|NCT01081795|B4|Baseline|Total|Total of all reporting groups
235112|NCT01081795|B3|Baseline|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235113|NCT01081795|B2|Baseline|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235114|NCT01081795|B1|Baseline|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235115|NCT01081795|P3|Participant Flow|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235116|NCT01081795|P2|Participant Flow|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235117|NCT01081795|P1|Participant Flow|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235118|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235119|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235120|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235121|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235190|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235191|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235122|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235123|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235124|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235125|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235126|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235127|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235128|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235129|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235130|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235131|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235132|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235133|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235134|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235135|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235136|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235192|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235193|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235137|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235138|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235139|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235140|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235141|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235142|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235143|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235144|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235145|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235146|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235147|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235148|NCT01081795|E3|Reported Event|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235149|NCT01081795|E2|Reported Event|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235150|NCT01081795|E1|Reported Event|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
235151|NCT01081769|B3|Baseline|Total|Total of all reporting groups
235152|NCT01081769|B2|Baseline|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
235153|NCT01081769|B1|Baseline|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
235154|NCT01081769|P2|Participant Flow|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
235155|NCT01081769|P1|Participant Flow|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
235156|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235157|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235158|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235159|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235160|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235161|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235162|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235163|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235164|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235165|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235166|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235167|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235168|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235169|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235170|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235171|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235172|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235173|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235174|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235175|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235176|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235177|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235178|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235179|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235180|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235181|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235182|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235183|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235184|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
235185|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
235186|NCT01081769|E2|Reported Event|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
235187|NCT01081769|E1|Reported Event|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
235188|NCT01081665|B1|Baseline|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235189|NCT01081665|P1|Participant Flow|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235195|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235196|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235197|NCT01081665|E1|Reported Event|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
235198|NCT01081626|B3|Baseline|Total|Total of all reporting groups
235199|NCT01081626|B2|Baseline|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235200|NCT01081626|B1|Baseline|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235201|NCT01081626|P2|Participant Flow|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235202|NCT01081626|P1|Participant Flow|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235203|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235204|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235205|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235206|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235207|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235208|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235209|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235210|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235211|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235212|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235213|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235214|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235215|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235216|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235217|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235218|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235219|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235220|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235853|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235221|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235222|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235223|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235224|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235225|NCT01081626|E2|Reported Event|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235226|NCT01081626|E1|Reported Event|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
235227|NCT01081301|B1|Baseline|Living With Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235228|NCT01081301|P1|Participant Flow|Living With Hope Program|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235229|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
235230|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
235231|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
235232|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
235233|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
235234|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235235|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
235236|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
235237|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
235238|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
235239|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
235240|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235241|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
235242|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
235243|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
235244|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
235245|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
235246|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235247|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|"12 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235248|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|"6 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235779|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235249|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|"3 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235250|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|"Day 14 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235251|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|"Day 7 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
235252|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|Baseline Measure
235253|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
235254|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
235255|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
235256|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
235257|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
235258|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|
235259|NCT01081301|E6|Reported Event|Living With Hope Program [12 Months]|
235260|NCT01081301|E5|Reported Event|Living With Hope Program [6 Months]|
235261|NCT01081301|E4|Reported Event|Living With Hope Program [3 Months]|
235262|NCT01081301|E3|Reported Event|Living With Hope Program [Day 14]|
235263|NCT01081301|E2|Reported Event|Living With Hope Program [Day 7]|
235264|NCT01081301|E1|Reported Event|Living With Hope Program [Baseline]|
235265|NCT01081249|B1|Baseline|Active Drug|"placebo~intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo~placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo"
235266|NCT01081249|P2|Participant Flow|Placebo Then Oxytocin|Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin.
235267|NCT01081249|P1|Participant Flow|Oxytocin Then Placebo|Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo.
235268|NCT01081249|O2|Outcome|Active Drug|A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
235269|NCT01081249|O1|Outcome|Placebo|A dose of intranasal placebo was administered prior to the psychotherapy session.
235270|NCT01081249|E2|Reported Event|Oxytocin Then Placebo|Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray.
235271|NCT01081249|E1|Reported Event|Placebo Then Oxytocin|Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.
235272|NCT01081145|B1|Baseline|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235273|NCT01081145|P2|Participant Flow|Placebo|Administered as a once-daily oral dose
235274|NCT01081145|P1|Participant Flow|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235275|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235276|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235277|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235278|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235279|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235280|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235281|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235282|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235283|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235284|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235285|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235286|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235287|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235288|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235289|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235290|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235291|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235854|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235292|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235293|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235294|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235295|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
235296|NCT01081145|E3|Reported Event|Guanfacine Hydrochloride (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235297|NCT01081145|E2|Reported Event|Placebo (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose
235298|NCT01081145|E1|Reported Event|Guanfacine Hydrochloride (Open-Label Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
235299|NCT01081132|B3|Baseline|Total|Total of all reporting groups
235300|NCT01081132|B2|Baseline|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235301|NCT01081132|B1|Baseline|PLACEBO|Orally administered a once-daily dose
235302|NCT01081132|P2|Participant Flow|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235303|NCT01081132|P1|Participant Flow|PLACEBO|Orally administered a once-daily dose
235304|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235305|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235306|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235307|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235308|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235309|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235310|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235311|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235312|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235313|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235314|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235315|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235316|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235317|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235318|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235319|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235320|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235321|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235322|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235323|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235324|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235325|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235326|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235327|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235328|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235329|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235330|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235331|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235332|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235333|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235334|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235335|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235336|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235337|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
235338|NCT01081132|E2|Reported Event|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
235339|NCT01081132|E1|Reported Event|PLACEBO|Orally administered a once-daily dose
235340|NCT01081041|B4|Baseline|Total|Total of all reporting groups
235341|NCT01081041|B3|Baseline|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235855|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235342|NCT01081041|B2|Baseline|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235343|NCT01081041|B1|Baseline|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235344|NCT01081041|P3|Participant Flow|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235345|NCT01081041|P2|Participant Flow|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235346|NCT01081041|P1|Participant Flow|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235347|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235348|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235349|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235350|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235351|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235352|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235353|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235354|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235355|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235356|NCT01081041|O1|Outcome|All Participants (Cetuximab)|"United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~OR~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly."
235357|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235358|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235359|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235360|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235361|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235362|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235363|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235364|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235365|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235366|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI),|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235367|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235368|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235369|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
235370|NCT01081041|E3|Reported Event|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235371|NCT01081041|E2|Reported Event|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235372|NCT01081041|E1|Reported Event|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
235373|NCT01080807|B3|Baseline|Total|Total of all reporting groups
235374|NCT01080807|B2|Baseline|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235375|NCT01080807|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235376|NCT01080807|P2|Participant Flow|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235377|NCT01080807|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235378|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235379|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235523|NCT01080209|P2|Participant Flow|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
235524|NCT01080209|P1|Participant Flow|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
235525|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
235380|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235381|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235382|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235383|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235384|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235385|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235386|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235387|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235388|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235389|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235390|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235526|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
235527|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
235391|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235392|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235393|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235394|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235395|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235396|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235397|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235398|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235399|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235400|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235401|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235528|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
235529|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
235402|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235403|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235404|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235405|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235406|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235407|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235408|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235409|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235410|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235411|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235412|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235530|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
235531|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
235413|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235414|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235415|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235416|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235417|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235418|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235419|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235420|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235421|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235422|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235423|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235532|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
235533|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
235856|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235424|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235425|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235426|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235427|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235428|NCT01080807|E2|Reported Event|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235429|NCT01080807|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
235430|NCT01080768|B3|Baseline|Total|Total of all reporting groups
235431|NCT01080768|B2|Baseline|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235432|NCT01080768|B1|Baseline|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235433|NCT01080768|P2|Participant Flow|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235434|NCT01080768|P1|Participant Flow|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235435|NCT01080768|O2|Outcome|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235436|NCT01080768|O1|Outcome|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235534|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
235535|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
235437|NCT01080768|E2|Reported Event|Amlodipine and Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235438|NCT01080768|E1|Reported Event|Aliskiren/Amlodipine and Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
235439|NCT01080625|B4|Baseline|Total|Total of all reporting groups
235440|NCT01080625|B3|Baseline|Control|10 ml of normal saline is administered at the time of reperfusion
235441|NCT01080625|B2|Baseline|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
235442|NCT01080625|B1|Baseline|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
235443|NCT01080625|P3|Participant Flow|Control|10 ml of normal saline is administered at the time of reperfusion
235444|NCT01080625|P2|Participant Flow|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
235445|NCT01080625|P1|Participant Flow|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
235446|NCT01080625|O3|Outcome|Control|10 ml of normal saline is administered at the time of reperfusion
235447|NCT01080625|O2|Outcome|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
235448|NCT01080625|O1|Outcome|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
235449|NCT01080625|E3|Reported Event|Control|10 ml of normal saline is administered at the time of reperfusion
235450|NCT01080625|E2|Reported Event|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
235451|NCT01080625|E1|Reported Event|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
235452|NCT01080391|B3|Baseline|Total|Total of all reporting groups
235453|NCT01080391|B2|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235454|NCT01080391|B1|Baseline|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235455|NCT01080391|P2|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235456|NCT01080391|P1|Participant Flow|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235457|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235458|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235459|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235460|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235461|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235462|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235463|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235464|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235465|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235466|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235467|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235468|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235469|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235470|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235471|NCT01080391|E2|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
235472|NCT01080391|E1|Reported Event|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
235473|NCT01080326|B1|Baseline|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
235474|NCT01080326|P1|Participant Flow|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
235475|NCT01080326|O1|Outcome|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
235536|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
235537|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
235538|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
235476|NCT01080326|E1|Reported Event|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
235477|NCT01080300|B3|Baseline|Total|Total of all reporting groups
235478|NCT01080300|B2|Baseline|Sugar Pill|Placebo 1800 mg
235479|NCT01080300|B1|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
235480|NCT01080300|P2|Participant Flow|Sugar Pill|Placebo 1800 mg
235481|NCT01080300|P1|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
235482|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
235483|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
235484|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
235485|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
235486|NCT01080300|E2|Reported Event|Sugar Pill|Placebo 1800 mg
235487|NCT01080300|E1|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
235488|NCT01080261|B1|Baseline|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235489|NCT01080261|P1|Participant Flow|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235490|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235491|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235492|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235493|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235494|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235495|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235496|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235497|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235498|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235499|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235500|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235501|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235502|NCT01080261|E1|Reported Event|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
235503|NCT01080248|B1|Baseline|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235504|NCT01080248|P1|Participant Flow|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235505|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235506|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235507|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235508|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235509|NCT01080248|E1|Reported Event|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
235510|NCT01080209|B8|Baseline|Total|Total of all reporting groups
235511|NCT01080209|B7|Baseline|Sham|Patients who received sham in a previous study.
235512|NCT01080209|B6|Baseline|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
235513|NCT01080209|B5|Baseline|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
235514|NCT01080209|B4|Baseline|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
235515|NCT01080209|B3|Baseline|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
235516|NCT01080209|B2|Baseline|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
235517|NCT01080209|B1|Baseline|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
235518|NCT01080209|P7|Participant Flow|Sham|Patients who received sham in a previous study.
235519|NCT01080209|P6|Participant Flow|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
235520|NCT01080209|P5|Participant Flow|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
235521|NCT01080209|P4|Participant Flow|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
235522|NCT01080209|P3|Participant Flow|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
235540|NCT01080209|E6|Reported Event|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
235541|NCT01080209|E5|Reported Event|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
235542|NCT01080209|E4|Reported Event|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
235543|NCT01080209|E3|Reported Event|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
235544|NCT01080209|E2|Reported Event|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
235545|NCT01080209|E1|Reported Event|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
235546|NCT01080131|B3|Baseline|Total|Total of all reporting groups
235547|NCT01080131|B2|Baseline|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
235548|NCT01080131|B1|Baseline|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
235549|NCT01080131|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
235550|NCT01080131|P1|Participant Flow|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
235551|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235552|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235553|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235554|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235555|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235556|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235557|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235558|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235559|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235560|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235685|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
249268|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
235561|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235562|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235563|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235564|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235565|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
235566|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
235567|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
235568|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
235569|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
235570|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
235571|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235572|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235573|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235574|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235619|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235575|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235576|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235577|NCT01080131|O6|Outcome|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
235578|NCT01080131|O5|Outcome|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
235579|NCT01080131|O4|Outcome|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
235580|NCT01080131|O3|Outcome|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
235581|NCT01080131|O2|Outcome|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
235582|NCT01080131|O1|Outcome|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
235583|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235584|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235585|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235586|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235587|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235588|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235686|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235857|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235589|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235590|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235591|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235592|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235593|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235594|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235595|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235596|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235597|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235598|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235599|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235600|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235601|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235620|NCT01080131|E6|Reported Event|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
235602|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235603|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
235604|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
235605|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235606|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235607|NCT01080131|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
235608|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235609|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235610|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235611|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235612|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235613|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235614|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235615|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235616|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235617|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235618|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
235683|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235684|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235621|NCT01080131|E5|Reported Event|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
235622|NCT01080131|E4|Reported Event|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
235623|NCT01080131|E3|Reported Event|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
235624|NCT01080131|E2|Reported Event|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
235625|NCT01080131|E1|Reported Event|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
235626|NCT01080118|B3|Baseline|Total|Total of all reporting groups
235627|NCT01080118|B2|Baseline|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
235628|NCT01080118|B1|Baseline|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
235629|NCT01080118|P4|Participant Flow|Video Laryngoscope Patients|Patients who were intubated using the video laryngoscope by interns or medical student.
235630|NCT01080118|P3|Participant Flow|Rigid Laryngoscope Patients|Patients who were intubated using the rigid laryngoscope by the medical student of intern.
235631|NCT01080118|P2|Participant Flow|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
235632|NCT01080118|P1|Participant Flow|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
235633|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
235634|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
235635|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
235636|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
235637|NCT01080118|E2|Reported Event|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
235638|NCT01080118|E1|Reported Event|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
235639|NCT01079988|B6|Baseline|Total|Total of all reporting groups
235640|NCT01079988|B5|Baseline|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
235641|NCT01079988|B4|Baseline|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
235642|NCT01079988|B3|Baseline|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
235643|NCT01079988|B2|Baseline|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
235644|NCT01079988|B1|Baseline|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
235645|NCT01079988|P5|Participant Flow|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
235646|NCT01079988|P4|Participant Flow|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
235647|NCT01079988|P3|Participant Flow|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
235648|NCT01079988|P2|Participant Flow|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
235649|NCT01079988|P1|Participant Flow|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
235650|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
235651|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
235652|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
235653|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
235654|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
235655|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
235656|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
235657|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
235658|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
235659|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
235660|NCT01079988|E5|Reported Event|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
235661|NCT01079988|E4|Reported Event|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
235662|NCT01079988|E3|Reported Event|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
235663|NCT01079988|E2|Reported Event|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
235664|NCT01079988|E1|Reported Event|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
235665|NCT01079962|B3|Baseline|Total|Total of all reporting groups
235666|NCT01079962|B2|Baseline|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235667|NCT01079962|B1|Baseline|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235668|NCT01079962|P2|Participant Flow|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235669|NCT01079962|P1|Participant Flow|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235670|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235671|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235672|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235673|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235674|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235675|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235676|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235677|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235678|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235679|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235680|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235681|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235682|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235858|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235687|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235688|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235689|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235690|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235691|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235692|NCT01079962|E2|Reported Event|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
235693|NCT01079962|E1|Reported Event|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
235694|NCT01079949|B3|Baseline|Total|Total of all reporting groups
235695|NCT01079949|B2|Baseline|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235696|NCT01079949|B1|Baseline|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235697|NCT01079949|P2|Participant Flow|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235698|NCT01079949|P1|Participant Flow|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235699|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235700|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235701|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235711|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235780|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235702|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235703|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235704|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235705|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235706|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235707|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235708|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235709|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235710|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235741|NCT01079936|B3|Baseline|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235859|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235712|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235713|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235714|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235715|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235716|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235717|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235718|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235719|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235720|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235742|NCT01079936|B2|Baseline|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235860|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235721|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235722|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235723|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235724|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235725|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235726|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235727|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235728|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235729|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235743|NCT01079936|B1|Baseline|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235744|NCT01079936|P5|Participant Flow|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235781|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235730|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235731|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235732|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235733|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235734|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235735|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235736|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235737|NCT01079949|E2|Reported Event|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235738|NCT01079949|E1|Reported Event|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
235739|NCT01079936|B5|Baseline|Total|Total of all reporting groups
235740|NCT01079936|B4|Baseline|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235745|NCT01079936|P4|Participant Flow|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235746|NCT01079936|P3|Participant Flow|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235747|NCT01079936|P2|Participant Flow|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235748|NCT01079936|P1|Participant Flow|Phase I: Lenalidomide + High-Dose Melphalan|Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235749|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235750|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235751|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235752|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235753|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235754|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235755|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235756|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235757|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235758|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235759|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235760|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235761|NCT01079936|O1|Outcome|Lenalidomide + High-Dose Melphalan|"Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.~Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2~Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion~Stem Cell Infusion: Stem cell infusion on Day 0."
235762|NCT01079936|E4|Reported Event|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235763|NCT01079936|E3|Reported Event|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235764|NCT01079936|E2|Reported Event|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235765|NCT01079936|E1|Reported Event|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
235766|NCT01079832|B1|Baseline|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235767|NCT01079832|P1|Participant Flow|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235768|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235769|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235770|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235771|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235772|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235773|NCT01079832|E1|Reported Event|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
235774|NCT01079806|B3|Baseline|Total|Total of all reporting groups
235775|NCT01079806|B2|Baseline|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235776|NCT01079806|B1|Baseline|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235777|NCT01079806|P2|Participant Flow|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235778|NCT01079806|P1|Participant Flow|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235839|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235782|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235783|NCT01079806|O2|Outcome|Placebo|Placebo: Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response
235784|NCT01079806|O1|Outcome|Entecavir|Entecavir: Tablets/Oral Solution, Oral, 0.015 mg/kg up to 0.5 mg, once daily, 96-144 weeks, depending on response
235785|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235786|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235787|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235788|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235789|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235790|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235791|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235792|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235793|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235794|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235795|NCT01079806|E2|Reported Event|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
235796|NCT01079806|E1|Reported Event|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
235797|NCT01079299|B3|Baseline|Total|Total of all reporting groups
235798|NCT01079299|B2|Baseline|Standard Compression Alone|
235799|NCT01079299|B1|Baseline|IPC Plus Standard Compression|
235800|NCT01079299|P2|Participant Flow|Standard Compression Alone|
235801|NCT01079299|P1|Participant Flow|IPC Plus Standard Compression|
235802|NCT01079299|O2|Outcome|Standard Compression Alone|
235803|NCT01079299|O1|Outcome|IPC Plus Standard Compression|
235804|NCT01079299|E2|Reported Event|Standard Compression Alone|
235805|NCT01079299|E1|Reported Event|IPC Plus Standard Compression|
235806|NCT01079234|B4|Baseline|Total|Total of all reporting groups
235807|NCT01079234|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235808|NCT01079234|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235809|NCT01079234|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235810|NCT01079234|P4|Participant Flow|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235811|NCT01079234|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235812|NCT01079234|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235813|NCT01079234|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235814|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235815|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235816|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235817|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235840|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235841|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
249269|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
235818|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235819|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235820|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235821|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235822|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235823|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235824|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235825|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235826|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235827|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
235828|NCT01079234|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
235829|NCT01079234|E1|Reported Event|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
235830|NCT01079195|B1|Baseline|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235831|NCT01079195|P1|Participant Flow|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235832|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235833|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235834|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235835|NCT01079195|E1|Reported Event|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
235836|NCT01079182|B1|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235837|NCT01079182|P1|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235838|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235861|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235862|NCT01079182|E1|Reported Event|Ankylosing Spondylitis|Participants with ankylosing spondylitis
235863|NCT01079143|B5|Baseline|Total|Total of all reporting groups
235864|NCT01079143|B4|Baseline|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235865|NCT01079143|B3|Baseline|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235866|NCT01079143|B2|Baseline|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235867|NCT01079143|B1|Baseline|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235868|NCT01079143|P4|Participant Flow|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235869|NCT01079143|P3|Participant Flow|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235870|NCT01079143|P2|Participant Flow|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235871|NCT01079143|P1|Participant Flow|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235872|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235873|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235874|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235875|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235876|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235877|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235878|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235879|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235880|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235881|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235882|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235883|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235884|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235885|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235886|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235887|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235888|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
236052|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
235889|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235890|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235891|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235892|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235893|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235894|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235895|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235896|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235897|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235898|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235899|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235900|NCT01079143|O2|Outcome|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235901|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235902|NCT01079143|O2|Outcome|Neoral|Between transplantation adn randomization, all patients have received Neoral. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic.
235903|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235904|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235905|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235906|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235907|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235908|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235909|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235910|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235911|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235912|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235913|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235914|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235998|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
235915|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235916|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235917|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235918|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235919|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235920|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235921|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235922|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235923|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235924|NCT01079143|O2|Outcome|No- No Fibrosis Progression|Participants who did not experience fibrosis progression based on IF/TA (univariate analysis)
235925|NCT01079143|O1|Outcome|Yes- Fibrosis Progression|Participants who experienced fibrosis progression based on IF/TA (univariate analysis)
235926|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235927|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235928|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235929|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235930|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235931|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235932|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235933|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235934|NCT01079143|O2|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235935|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235936|NCT01079143|E2|Reported Event|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
235937|NCT01079143|E1|Reported Event|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
235938|NCT01079130|B7|Baseline|Total|Total of all reporting groups
235939|NCT01079130|B6|Baseline|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235940|NCT01079130|B5|Baseline|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
236047|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236048|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
235941|NCT01079130|B4|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235942|NCT01079130|B3|Baseline|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235943|NCT01079130|B2|Baseline|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235944|NCT01079130|B1|Baseline|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
235945|NCT01079130|P6|Participant Flow|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235946|NCT01079130|P5|Participant Flow|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235947|NCT01079130|P4|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235948|NCT01079130|P3|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235949|NCT01079130|P2|Participant Flow|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235950|NCT01079130|P1|Participant Flow|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
235951|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235952|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235953|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235954|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235955|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235956|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
235957|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
236049|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
249270|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
235958|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235959|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235960|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235961|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235962|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
235963|NCT01079130|E6|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235964|NCT01079130|E5|Reported Event|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235965|NCT01079130|E4|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235966|NCT01079130|E3|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235967|NCT01079130|E2|Reported Event|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
235968|NCT01079130|E1|Reported Event|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
235969|NCT01078974|B1|Baseline|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
235970|NCT01078974|P1|Participant Flow|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
235971|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
235972|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
235973|NCT01078974|E1|Reported Event|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
236050|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236051|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
235974|NCT01078922|B1|Baseline|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
235975|NCT01078922|P1|Participant Flow|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
235976|NCT01078922|O1|Outcome|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
235977|NCT01078922|O1|Outcome|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
235978|NCT01078922|E1|Reported Event|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
235979|NCT01078805|B1|Baseline|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235980|NCT01078805|P1|Participant Flow|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235981|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235982|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235983|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235984|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235985|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235986|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235987|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235988|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235989|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235990|NCT01078805|E1|Reported Event|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
235991|NCT01078753|B3|Baseline|Total|Total of all reporting groups
235992|NCT01078753|B2|Baseline|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
235993|NCT01078753|B1|Baseline|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
235994|NCT01078753|P2|Participant Flow|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
235995|NCT01078753|P1|Participant Flow|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
235996|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
235997|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
235999|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
236000|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
236001|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
236002|NCT01078753|E2|Reported Event|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
236003|NCT01078753|E1|Reported Event|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
236004|NCT01078675|B3|Baseline|Total|Total of all reporting groups
236005|NCT01078675|B2|Baseline|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
236006|NCT01078675|B1|Baseline|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236007|NCT01078675|P2|Participant Flow|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
236008|NCT01078675|P1|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236009|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236010|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
236011|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
236012|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236013|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236014|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236015|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236016|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236017|NCT01078675|O2|Outcome|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
236018|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236019|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236020|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
236021|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236022|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236023|NCT01078675|E1|Reported Event|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
236024|NCT01078662|B6|Baseline|Total|Total of all reporting groups
236025|NCT01078662|B5|Baseline|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236026|NCT01078662|B4|Baseline|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236027|NCT01078662|B3|Baseline|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236028|NCT01078662|B2|Baseline|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236029|NCT01078662|B1|Baseline|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236030|NCT01078662|P5|Participant Flow|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236031|NCT01078662|P4|Participant Flow|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236032|NCT01078662|P3|Participant Flow|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236033|NCT01078662|P2|Participant Flow|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236034|NCT01078662|P1|Participant Flow|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236035|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
236036|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236037|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236038|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236039|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236040|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236041|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
236042|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236043|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236044|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236045|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236046|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
249271|NCT01037244|O4|Outcome|Placebo|Placebo tablets
236053|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236054|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236055|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236056|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236057|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236058|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236059|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
236060|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236061|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236062|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236063|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236064|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236065|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
236066|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
236067|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
236068|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
236069|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
236070|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
236071|NCT01078662|E1|Reported Event|OLAPARIB|
236072|NCT01078623|B1|Baseline|Overall Study Population|All patients randomized into the study
236073|NCT01078623|P20|Participant Flow|Sequence 20|Placebo - Formoterol 12 - Aclidinium 200 - FDC 200/12
236074|NCT01078623|P19|Participant Flow|Sequence 19|Formoterol 12 - Aclidinium 200 - FDC 200/12 - FDC 200/6
236075|NCT01078623|P18|Participant Flow|Sequence 18|Aclidinium 200 - FDC 200/12 - FDC 200/6 - Placebo
236076|NCT01078623|P17|Participant Flow|Sequence 17|FDC 200/12 - FDC 200/6 - Placebo - Formoterol 12
236077|NCT01078623|P16|Participant Flow|Sequence 16|FDC 200/6 - Placebo - Formoterol 12 - Aclidinium 200
236078|NCT01078623|P15|Participant Flow|Sequence 15|Placebo - Aclidinium 200 - FDC 200/6 - Formoterol 12
236079|NCT01078623|P14|Participant Flow|Sequence 14|Formoterol 12 - FDC 200/12 - Placebo - Aclidinium 200
236080|NCT01078623|P13|Participant Flow|Sequence 13|Aclidinium 200 - FDC 200/6 - Formoterol 12 - FDC 200/12
236081|NCT01078623|P12|Participant Flow|Sequence 12|FDC 200/12 - Placebo - Aclidinium 200 - FDC 200/6
236082|NCT01078623|P11|Participant Flow|Sequence 11|FDC 200/6 - Formoterol 12 - FDC 200/12 - Placebo
236083|NCT01078623|P10|Participant Flow|Sequence 10|Placebo - FDC 200/12 - Formoterol 12 - FDC 200/6
236084|NCT01078623|P9|Participant Flow|Sequence 9|Formoterol 12 - FDC 200/6 - Aclidinium 200 - Placebo
236085|NCT01078623|P8|Participant Flow|Sequence 8|Aclidinium 200 - Placebo - FDC 200/12 - Formoterol 12
236086|NCT01078623|P7|Participant Flow|Sequence 7|FDC 200/12 - Formoterol 12 - FDC 200/6 - Aclidinium 200
236087|NCT01078623|P6|Participant Flow|Sequence 6|FDC 200/6 - Aclidinium 200 - Placebo - FDC 200/12
236088|NCT01078623|P5|Participant Flow|Sequence 5|Placebo - FDC 200/6 - FDC 200/12 - Aclidinium 200
236089|NCT01078623|P4|Participant Flow|Sequence 4|Formoterol 12 - Placebo - FDC 200/6 - FDC 200/12
236090|NCT01078623|P3|Participant Flow|Sequence 3|Aclidinium 200 - Formoterol 12 - Placebo - FDC 200/6
236091|NCT01078623|P2|Participant Flow|Sequence 2|FDC 200/12 - Aclidinium 200 - Formoterol 12 - Placebo
236092|NCT01078623|P1|Participant Flow|Sequence 1|FDC 200/6 μg - FDC 200/12 μg - Aclidinium 200 μg - Formoterol 12 μg
236093|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
236094|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
236095|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
236096|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
236097|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
236098|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
236099|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
236100|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
236101|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
236102|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
236103|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
236104|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
236105|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
236106|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
236107|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
236108|NCT01078623|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
236109|NCT01078623|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
236110|NCT01078623|E3|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
236372|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236111|NCT01078623|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
236112|NCT01078623|E1|Reported Event|Placebo|Placebo twice daily
236113|NCT01078584|B1|Baseline|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236114|NCT01078584|P1|Participant Flow|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236115|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236116|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236117|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236118|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236119|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236120|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236121|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236122|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236123|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236124|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236125|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236126|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236127|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236128|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236129|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236130|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
236131|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
236132|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236133|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236134|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
236135|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
236136|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236137|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236138|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
236139|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
236140|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236141|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236142|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236143|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236144|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236145|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236686|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236146|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236147|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236148|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236149|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236150|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236151|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236152|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236153|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236154|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236155|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236156|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236157|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236158|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236159|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236160|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236161|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236162|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236203|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
236163|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236164|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236165|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236166|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236167|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
236168|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236169|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236170|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236171|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236172|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236173|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236174|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236175|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236176|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236177|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236178|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236179|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236180|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236181|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236182|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236183|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236184|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
236185|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
236186|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236187|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236188|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236189|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236190|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236191|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236192|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236193|NCT01078584|E1|Reported Event|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
236194|NCT01078571|B1|Baseline|Adalimumab (Humira)|
236195|NCT01078571|P1|Participant Flow|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
236196|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months|Participants who had been taking adalimumab for 4 months or longer.
236197|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as de novo participants."
236198|NCT01078571|O2|Outcome|Adalimumab (Treatment for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
236199|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
236200|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
236201|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
236202|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
236204|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
236205|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
236206|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
236207|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
236208|NCT01078571|O1|Outcome|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
236209|NCT01078571|E1|Reported Event|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
236210|NCT01078545|B1|Baseline|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236211|NCT01078545|P1|Participant Flow|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236212|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236213|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236214|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236215|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236216|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236217|NCT01078545|E1|Reported Event|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
236218|NCT01078454|B3|Baseline|Total|Total of all reporting groups
236219|NCT01078454|B2|Baseline|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
236220|NCT01078454|B1|Baseline|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
236221|NCT01078454|P2|Participant Flow|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
236222|NCT01078454|P1|Participant Flow|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
236223|NCT01078454|O2|Outcome|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
236224|NCT01078454|O1|Outcome|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
236225|NCT01078454|E2|Reported Event|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
236226|NCT01078454|E1|Reported Event|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
236227|NCT01078441|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
236228|NCT01078441|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
236229|NCT01078441|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
236230|NCT01078441|E1|Reported Event|Combination Chemotherapy|Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
236231|NCT01078402|B4|Baseline|Total|Total of all reporting groups
236232|NCT01078402|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236233|NCT01078402|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236234|NCT01078402|B1|Baseline|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236235|NCT01078402|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236236|NCT01078402|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236237|NCT01078402|P1|Participant Flow|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236238|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236239|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236240|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236241|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236242|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236243|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236244|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236245|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236246|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236247|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236248|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236249|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236250|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236251|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236252|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236253|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236254|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236255|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236256|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236257|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236258|NCT01078402|O2|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236259|NCT01078402|O1|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236260|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236261|NCT01078402|E4|Reported Event|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
236262|NCT01078402|E3|Reported Event|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
236263|NCT01078402|E2|Reported Event|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
236264|NCT01078402|E1|Reported Event|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
236265|NCT01078389|B3|Baseline|Total|Total of all reporting groups
236266|NCT01078389|B2|Baseline|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236267|NCT01078389|B1|Baseline|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236268|NCT01078389|P2|Participant Flow|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236269|NCT01078389|P1|Participant Flow|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236270|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236271|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236272|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236273|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236274|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236275|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236276|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236277|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236278|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236279|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236280|NCT01078389|E2|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
236281|NCT01078389|E1|Reported Event|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
236282|NCT01078376|B5|Baseline|Total|Total of all reporting groups
236283|NCT01078376|B4|Baseline|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236284|NCT01078376|B3|Baseline|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236285|NCT01078376|B2|Baseline|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236286|NCT01078376|B1|Baseline|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236287|NCT01078376|P4|Participant Flow|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236288|NCT01078376|P3|Participant Flow|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236289|NCT01078376|P2|Participant Flow|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236290|NCT01078376|P1|Participant Flow|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236291|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236292|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236293|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236294|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236295|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236296|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236297|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236298|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236299|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236300|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236301|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236302|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236303|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236304|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236305|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236306|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236307|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236308|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236309|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236310|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236311|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236312|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236313|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236314|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236315|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236316|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236317|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236318|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236319|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236320|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236321|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236322|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236323|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236324|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236325|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236326|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236327|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236328|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236329|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236330|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236331|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236332|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236333|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236334|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236335|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236336|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236337|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236338|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236339|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236340|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236341|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236342|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236343|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236344|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236345|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236346|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236347|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236348|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236349|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236350|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236351|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236352|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236353|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236354|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236355|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236356|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236357|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236358|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236359|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236360|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236361|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236362|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236363|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236364|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236365|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236366|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236367|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236368|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236369|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236370|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236371|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236373|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236374|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236375|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236376|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236377|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236378|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236379|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236380|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236381|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236382|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236383|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236384|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236385|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236386|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236387|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236388|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236389|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236390|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236391|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236392|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236393|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236394|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236395|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236396|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236397|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236398|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
236399|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236400|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236401|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
236402|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
236403|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236404|NCT01078376|E4|Reported Event|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
236405|NCT01078376|E3|Reported Event|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236406|NCT01078376|E2|Reported Event|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
236407|NCT01078376|E1|Reported Event|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
236408|NCT01078363|B3|Baseline|Total|Total of all reporting groups
236409|NCT01078363|B2|Baseline|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236410|NCT01078363|B1|Baseline|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236411|NCT01078363|P2|Participant Flow|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236412|NCT01078363|P1|Participant Flow|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236413|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236523|NCT01078220|B1|Baseline|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
236414|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236415|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236416|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236417|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236418|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236419|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~Placebo: Use of a placebo post heart Transplant for Blood pressure control."
236420|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril: Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control."
236421|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236422|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236423|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236424|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236425|NCT01078363|E2|Reported Event|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236426|NCT01078363|E1|Reported Event|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
236427|NCT01078298|B3|Baseline|Total|Total of all reporting groups
236428|NCT01078298|B2|Baseline|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236429|NCT01078298|B1|Baseline|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236430|NCT01078298|P2|Participant Flow|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236431|NCT01078298|P1|Participant Flow|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236432|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236433|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236434|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236435|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236436|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236437|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236438|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236439|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236440|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236441|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236442|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236443|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236444|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236445|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236446|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236447|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236448|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236449|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236450|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236451|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236452|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236453|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236454|NCT01078298|E2|Reported Event|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236455|NCT01078298|E1|Reported Event|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
236456|NCT01078246|B8|Baseline|Total|Total of all reporting groups
236457|NCT01078246|B7|Baseline|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
236458|NCT01078246|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
236459|NCT01078246|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
236460|NCT01078246|B4|Baseline|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
236461|NCT01078246|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
236462|NCT01078246|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
236463|NCT01078246|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
236464|NCT01078246|P7|Participant Flow|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
236465|NCT01078246|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
236466|NCT01078246|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
236467|NCT01078246|P4|Participant Flow|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
236468|NCT01078246|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
236469|NCT01078246|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
236470|NCT01078246|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
236471|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236472|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236473|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236474|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236475|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236476|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236477|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236478|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236479|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236480|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236481|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236482|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236483|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236568|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
236484|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236485|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236486|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236487|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236488|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236489|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236490|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236491|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236492|NCT01078246|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236493|NCT01078246|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
236494|NCT01078246|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236495|NCT01078233|B7|Baseline|Total|Total of all reporting groups
236496|NCT01078233|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
236497|NCT01078233|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
236498|NCT01078233|B4|Baseline|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
236499|NCT01078233|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
236500|NCT01078233|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
236501|NCT01078233|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
236502|NCT01078233|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
236503|NCT01078233|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
236522|NCT01078233|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236569|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
236504|NCT01078233|P4|Participant Flow|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
236505|NCT01078233|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
236506|NCT01078233|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
236507|NCT01078233|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
236508|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
236509|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
236510|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236511|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
236512|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
236513|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236514|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
236515|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
236516|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236517|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
236518|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
236519|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
236520|NCT01078233|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
236521|NCT01078233|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
236570|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
236571|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
236524|NCT01078220|P1|Participant Flow|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
236525|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
236526|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
236527|NCT01078220|O1|Outcome|Autoimmune Safety Population|Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.
236528|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
236529|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
236530|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
236531|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
236532|NCT01078220|E1|Reported Event|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
236533|NCT01078207|B1|Baseline|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
236534|NCT01078207|P1|Participant Flow|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
236535|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
236536|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
236537|NCT01078207|E1|Reported Event|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
236538|NCT01078155|B1|Baseline|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236539|NCT01078155|P1|Participant Flow|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant’s enrollment in the study.
236540|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236541|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236542|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236543|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236544|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236572|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
236573|NCT01078090|O1|Outcome|Month 0|Baseline
236574|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236882|NCT01077830|B3|Baseline|Total|Total of all reporting groups
236545|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236546|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236547|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236548|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236549|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236550|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236551|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236552|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236553|NCT01078155|E1|Reported Event|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
236554|NCT01078116|B1|Baseline|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236555|NCT01078116|P1|Participant Flow|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236556|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236557|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236558|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236559|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236560|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236561|NCT01078116|E1|Reported Event|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
236562|NCT01078090|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236563|NCT01078090|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236564|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
236565|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
236566|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
236567|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
236575|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236576|NCT01078090|O5|Outcome|Month 30|30 months after inclusion
236577|NCT01078090|O4|Outcome|Month 24|24 months after inclusion
236578|NCT01078090|O3|Outcome|Month 18|18 months after inclusion
236579|NCT01078090|O2|Outcome|Month 6|6 months after inclusion
236580|NCT01078090|O1|Outcome|Month 0|Baseline
236581|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236582|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236583|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236584|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236585|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236586|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236587|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236588|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236589|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
236590|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
236591|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
236592|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
236593|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
236594|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
236595|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
236596|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
236597|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
236598|NCT01078090|O1|Outcome|Month 0|Baseline
236599|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236600|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236601|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236602|NCT01078090|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
236603|NCT01077973|B4|Baseline|Total|Total of all reporting groups
236604|NCT01077973|B3|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236605|NCT01077973|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236606|NCT01077973|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236607|NCT01077973|P3|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236608|NCT01077973|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236609|NCT01077973|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236610|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236611|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236612|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236613|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236614|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236615|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236616|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236617|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236618|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236619|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236620|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236621|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236622|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236623|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236624|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236625|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236626|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236627|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236628|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236629|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236630|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236631|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236632|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236633|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236634|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236635|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236636|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236637|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236638|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236639|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236640|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236641|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236642|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236643|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236644|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236645|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236646|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236647|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236685|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236648|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236649|NCT01077973|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236650|NCT01077973|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236651|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236652|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236653|NCT01077973|E3|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236654|NCT01077973|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
236655|NCT01077973|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
236656|NCT01077960|B1|Baseline|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236657|NCT01077960|P1|Participant Flow|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236658|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236659|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236660|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236661|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236662|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236663|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236664|NCT01077960|E1|Reported Event|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
236665|NCT01077921|B3|Baseline|Total|Total of all reporting groups
236666|NCT01077921|B2|Baseline|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
236667|NCT01077921|B1|Baseline|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
236668|NCT01077921|P2|Participant Flow|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
236669|NCT01077921|P1|Participant Flow|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
236670|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236671|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236672|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236673|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236674|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236675|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236676|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236677|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236678|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236679|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236680|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236681|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236682|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236683|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236684|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236687|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236688|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236689|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236690|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236691|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236692|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
236693|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236694|NCT01077921|O2|Outcome|Placebo|All subjects completing the placebo treatment phase.
236695|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
236696|NCT01077921|E2|Reported Event|Placebo|Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
236697|NCT01077921|E1|Reported Event|Propranolol|Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
236698|NCT01077856|B4|Baseline|Total|Total of all reporting groups
236699|NCT01077856|B3|Baseline|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
236700|NCT01077856|B2|Baseline|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
236701|NCT01077856|B1|Baseline|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
236702|NCT01077856|P3|Participant Flow|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
236703|NCT01077856|P2|Participant Flow|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
236704|NCT01077856|P1|Participant Flow|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
236705|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
236706|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
236707|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
236708|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
236709|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
236710|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
236711|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
236712|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
236713|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
236714|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
236715|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
236716|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
236717|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
236718|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
236719|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
236720|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
236721|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
236722|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
236723|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
236724|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
236725|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
236726|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
236727|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
236728|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
236729|NCT01077856|O6|Outcome|Babies Born to Sweden Participants|Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil
236730|NCT01077856|O5|Outcome|Babies Born to Sweden Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy
236731|NCT01077856|O4|Outcome|Babies Born to Norway Participants|Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil
236732|NCT01077856|O3|Outcome|Babies Born to Norway Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy
236733|NCT01077856|O2|Outcome|Babies Born to Denmark Participants|Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil
236734|NCT01077856|O1|Outcome|Babies Born to Denmark Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy
236735|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236736|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236737|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236738|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236739|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236740|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236741|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236742|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236743|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236744|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236745|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236746|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236747|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236748|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236749|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236750|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236751|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236752|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236753|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236754|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236755|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236756|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236757|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236758|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236759|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236760|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236761|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236762|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236763|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236764|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236765|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236766|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236767|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236768|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236769|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236770|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236771|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236772|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236773|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236774|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236775|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236776|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236777|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236778|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236779|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236780|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236781|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236782|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236783|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236784|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236785|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236786|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236787|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236788|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236789|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236790|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236791|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236792|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236793|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236794|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236795|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236796|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236797|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236798|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236799|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236800|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236801|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236802|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236803|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236804|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236805|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236806|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236807|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236808|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236809|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236810|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236811|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236812|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236813|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236814|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236815|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236816|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236817|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236818|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236819|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
236820|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236821|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
236822|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236823|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
236824|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236825|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
236826|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
236827|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
236828|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
236829|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
236830|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236831|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
236832|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
236833|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
236834|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
236835|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
236836|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236837|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
236838|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
236839|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
236840|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
236841|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
236842|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
236843|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
236844|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
236845|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
236846|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
236847|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
236848|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236849|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
236850|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
236851|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
236852|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
236853|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
236854|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236855|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
236856|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
236857|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
236858|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
236859|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
236860|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
236861|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
236862|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
236863|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
236864|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
236865|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
236866|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236867|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
236868|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
236869|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
236870|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
236871|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
236872|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236873|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
236874|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
236875|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
236876|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
236877|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
236878|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
236879|NCT01077856|E3|Reported Event|Sweden Participants|All Sweden study participants
236880|NCT01077856|E2|Reported Event|Norway Participants|All Norway study participants
236881|NCT01077856|E1|Reported Event|Denmark Participants|All Denmark study participants
236883|NCT01077830|B2|Baseline|Placebo|Participants who received placebo in the base study
236884|NCT01077830|B1|Baseline|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
236885|NCT01077830|P2|Participant Flow|Placebo|Participantss who received placebo in the base study
236886|NCT01077830|P1|Participant Flow|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
236887|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
236888|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
236889|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
236890|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
236891|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
236892|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
236893|NCT01077830|E2|Reported Event|Placebo|Participants who were assigned to the placebo cohort in the base study
236894|NCT01077830|E1|Reported Event|Ezetimibe/Simvastatin 10/40 mg|Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
236895|NCT01077817|B1|Baseline|Overall Study Population|
236896|NCT01077817|P1|Participant Flow|Overall Study Population|
236897|NCT01077817|O6|Outcome|Raloxifene|Participants who initiated osteoporosis treatment with raloxifene
236898|NCT01077817|O5|Outcome|Risendronate|Participants who initiated osteoporosis treatment with risedronate
236899|NCT01077817|O4|Outcome|Ibandronate|Participants who initiated osteoporosis treatment with ibandronate
236900|NCT01077817|O3|Outcome|Etidronate|Participants who initiated osteoporosis treatment with etidronate
236901|NCT01077817|O2|Outcome|Alendronate|Participants who initiated osteoporosis treatment with alendronate
236902|NCT01077817|O1|Outcome|Comparators|Participants who did not initiate osteoporosis treatment with a study drug
236903|NCT01077817|O2|Outcome|Comparison Sample (Case Cohort)|Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
236904|NCT01077817|O1|Outcome|Esophageal Cancer Cohort|Participants with any GPRD Medical Code for esophageal cancer (cases).
236905|NCT01077817|E1|Reported Event|Overall Study Population|
236906|NCT01077804|B1|Baseline|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236907|NCT01077804|P1|Participant Flow|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236908|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236909|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236910|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236911|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236912|NCT01077804|E1|Reported Event|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
236913|NCT01077739|B3|Baseline|Total|Total of all reporting groups
236914|NCT01077739|B2|Baseline|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236915|NCT01077739|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236916|NCT01077739|P2|Participant Flow|Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236917|NCT01077739|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236935|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236918|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236919|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236920|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236921|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236922|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236923|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236924|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236925|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236926|NCT01077739|E2|Reported Event|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
236927|NCT01077739|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
236928|NCT01077713|B3|Baseline|Total|Total of all reporting groups
236929|NCT01077713|B2|Baseline|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236930|NCT01077713|B1|Baseline|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236931|NCT01077713|P2|Participant Flow|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236932|NCT01077713|P1|Participant Flow|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236933|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236934|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
237026|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
236936|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236937|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236938|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236939|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236940|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236941|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236942|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236943|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236944|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236945|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236946|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236947|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236948|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236949|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236950|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236951|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236952|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
237027|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
249272|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
236953|NCT01077713|E2|Reported Event|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
236954|NCT01077713|E1|Reported Event|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
236955|NCT01077622|B1|Baseline|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236956|NCT01077622|P1|Participant Flow|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236957|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236958|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236959|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236960|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236961|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236962|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236963|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236964|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236965|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236966|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236967|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236968|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236969|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236970|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236971|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236972|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236973|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
238253|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
236974|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236975|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236976|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236977|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236978|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236979|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236980|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236981|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236982|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236983|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236984|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236985|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236986|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236987|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236988|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236989|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236990|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236991|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236992|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236993|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236994|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
237028|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
249273|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
236995|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236996|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236997|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236998|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
236999|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
237000|NCT01077622|E1|Reported Event|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
237001|NCT01077596|B13|Baseline|Total|Total of all reporting groups
237002|NCT01077596|B12|Baseline|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
237003|NCT01077596|B11|Baseline|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
237004|NCT01077596|B10|Baseline|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
237005|NCT01077596|B9|Baseline|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
237006|NCT01077596|B8|Baseline|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
237007|NCT01077596|B7|Baseline|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
237008|NCT01077596|B6|Baseline|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
237009|NCT01077596|B5|Baseline|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
237010|NCT01077596|B4|Baseline|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
237011|NCT01077596|B3|Baseline|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
237012|NCT01077596|B2|Baseline|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
237013|NCT01077596|B1|Baseline|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
237014|NCT01077596|P12|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
237015|NCT01077596|P11|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
237016|NCT01077596|P10|Participant Flow|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
237017|NCT01077596|P9|Participant Flow|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
237018|NCT01077596|P8|Participant Flow|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
237019|NCT01077596|P7|Participant Flow|Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
237020|NCT01077596|P6|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
237021|NCT01077596|P5|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
237022|NCT01077596|P4|Participant Flow|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
237023|NCT01077596|P3|Participant Flow|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
237024|NCT01077596|P2|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
237025|NCT01077596|P1|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
238254|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
237029|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237030|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237031|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
237032|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237033|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
237034|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237035|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237036|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
237037|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237038|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
237039|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237040|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237041|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
237042|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237043|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
237044|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237045|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237046|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
237047|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237048|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
237049|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237050|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237051|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
237052|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237053|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
237054|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237055|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237056|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular “other” antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
237057|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
237058|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
237059|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
237060|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
237061|NCT01077596|E12|Reported Event|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
237062|NCT01077596|E11|Reported Event|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
237063|NCT01077596|E10|Reported Event|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
237064|NCT01077596|E9|Reported Event|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
237065|NCT01077596|E8|Reported Event|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
237066|NCT01077596|E7|Reported Event|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
237067|NCT01077596|E6|Reported Event|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
237068|NCT01077596|E5|Reported Event|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
237069|NCT01077596|E4|Reported Event|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
237070|NCT01077596|E3|Reported Event|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
237071|NCT01077596|E2|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
237072|NCT01077596|E1|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
237073|NCT01077544|B3|Baseline|Total|Total of all reporting groups
237074|NCT01077544|B2|Baseline|Group 2|>= 10 years to <18 years pediatric patients
237075|NCT01077544|B1|Baseline|Group 1|1 year to < 10 years pediatric patients
237076|NCT01077544|P2|Participant Flow|Group 2|>= 10 years to <18 years pediatric patients
237077|NCT01077544|P1|Participant Flow|Group 1|1 year to < 10 years pediatric patients
237078|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237079|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237080|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237081|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237082|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237083|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237084|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237085|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237086|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237087|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237088|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237089|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237090|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237091|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237092|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237093|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237094|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237095|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237096|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237097|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237098|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
237099|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
237100|NCT01077544|E2|Reported Event|Group 2|>= 10 years to <18 years pediatric patients
237101|NCT01077544|E1|Reported Event|Group 1|1 year to < 10 years pediatric patients
237102|NCT01077375|B3|Baseline|Total|Total of all reporting groups
237103|NCT01077375|B2|Baseline|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."
237104|NCT01077375|B1|Baseline|Placebo|Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
237105|NCT01077375|P2|Participant Flow|Milnacipran|Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
237106|NCT01077375|P1|Participant Flow|Placebo|Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
237107|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"
237108|NCT01077375|O1|Outcome|Placebo|Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
237109|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
249274|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
237110|NCT01077375|O1|Outcome|Placebo|Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
237111|NCT01077375|E2|Reported Event|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
237112|NCT01077375|E1|Reported Event|Placebo|Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
237113|NCT01077362|B4|Baseline|Total|Total of all reporting groups
237114|NCT01077362|B3|Baseline|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237115|NCT01077362|B2|Baseline|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237116|NCT01077362|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237117|NCT01077362|P3|Participant Flow|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237118|NCT01077362|P2|Participant Flow|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237119|NCT01077362|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237120|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237121|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237122|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237123|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237124|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237125|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237126|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237127|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237128|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237129|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237130|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237131|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237132|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237133|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237134|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237135|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237136|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237137|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237138|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237139|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237140|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
237141|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237142|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
237143|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
237144|NCT01077362|E7|Reported Event|Ustekinumab 90 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
237145|NCT01077362|E6|Reported Event|Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
237146|NCT01077362|E5|Reported Event|Placebo -> Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
237147|NCT01077362|E4|Reported Event|Placebo: Weeks 16-24|Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
237148|NCT01077362|E3|Reported Event|Ustekinumab 90 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
237149|NCT01077362|E2|Reported Event|Ustekinumab 45 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
237150|NCT01077362|E1|Reported Event|Placebo: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
237151|NCT01077323|B4|Baseline|Total|Total of all reporting groups
237152|NCT01077323|B3|Baseline|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237169|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237153|NCT01077323|B2|Baseline|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237154|NCT01077323|B1|Baseline|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237155|NCT01077323|P3|Participant Flow|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237156|NCT01077323|P2|Participant Flow|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237157|NCT01077323|P1|Participant Flow|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237158|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237159|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237160|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237161|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237162|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237163|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237164|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237165|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237166|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237167|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237168|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237226|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237170|NCT01077323|E3|Reported Event|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
237171|NCT01077323|E2|Reported Event|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
237172|NCT01077323|E1|Reported Event|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
237173|NCT01077310|B3|Baseline|Total|Total of all reporting groups
237174|NCT01077310|B2|Baseline|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237175|NCT01077310|B1|Baseline|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237176|NCT01077310|P2|Participant Flow|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237177|NCT01077310|P1|Participant Flow|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237178|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
237179|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
237180|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237181|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237182|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
237183|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
237184|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237185|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237186|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237187|NCT01077310|O1|Outcome|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237227|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
238255|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
237188|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237189|NCT01077310|O1|Outcome|Intramuscular Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237190|NCT01077310|E2|Reported Event|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
237191|NCT01077310|E1|Reported Event|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
237192|NCT01077284|B4|Baseline|Total|Total of all reporting groups
237193|NCT01077284|B3|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237194|NCT01077284|B2|Baseline|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237195|NCT01077284|B1|Baseline|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237196|NCT01077284|P3|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237197|NCT01077284|P2|Participant Flow|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237198|NCT01077284|P1|Participant Flow|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237199|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237200|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237201|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237202|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237203|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237204|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237205|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237206|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237207|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237208|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237209|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237210|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237211|NCT01077284|E3|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
237212|NCT01077284|E2|Reported Event|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
237213|NCT01077284|E1|Reported Event|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
237214|NCT01077271|B5|Baseline|Total|Total of all reporting groups
237215|NCT01077271|B4|Baseline|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237216|NCT01077271|B3|Baseline|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237217|NCT01077271|B2|Baseline|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237218|NCT01077271|B1|Baseline|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237219|NCT01077271|P1|Participant Flow|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
237220|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237221|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237222|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237223|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237224|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237225|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237228|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237229|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237230|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237231|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237232|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237233|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237234|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237235|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237236|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237237|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237238|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237239|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237240|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237241|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237242|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237243|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237244|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237245|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237246|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237247|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237248|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237249|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237250|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
237251|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
237252|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
237253|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
237254|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
237255|NCT01077271|E1|Reported Event|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
237256|NCT01077258|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237257|NCT01077258|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237258|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
237259|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
237260|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
237261|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
237262|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
237263|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
237264|NCT01077258|O1|Outcome|Month 0|Baseline
237265|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237266|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237267|NCT01077258|O6|Outcome|Month 24|24 months after inclusion
237268|NCT01077258|O5|Outcome|Month 18|18 months after inclusion
237269|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
237273|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237274|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237275|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237276|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237277|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237278|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237279|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237280|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237281|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
237282|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
237283|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
237284|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
237285|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
237286|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
237287|NCT01077258|O1|Outcome|Month 0|Baseline
237288|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237289|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237290|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237291|NCT01077258|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
237292|NCT01077193|B1|Baseline|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
237293|NCT01077193|P1|Participant Flow|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
237294|NCT01077193|O1|Outcome|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
237295|NCT01077193|E1|Reported Event|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
237296|NCT01077128|B1|Baseline|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
237297|NCT01077128|P1|Participant Flow|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
237298|NCT01077128|O1|Outcome|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
237299|NCT01077128|O4|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 12|All eligible patients with psoriasis treated with Adalimumab
237300|NCT01077128|O3|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 8|All eligible patients with psoriasis treated with Adalimumab
237301|NCT01077128|O2|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 4|All eligible patients with psoriasis treated with Adalimumab
237302|NCT01077128|O1|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 1|All eligible patients with psoriasis treated with Adalimumab
237303|NCT01077128|O25|Outcome|EQ5D- Anxiety/Depression- Month 12|All eligible patients with psoriasis treated with Adalimumab
237304|NCT01077128|O24|Outcome|EQ5D- Anxiety/Depression- Month 8|All eligible patients with psoriasis treated with Adalimumab
237305|NCT01077128|O23|Outcome|EQ5D- Anxiety/Depression- Month 4|All eligible patients with psoriasis treated with Adalimumab
237306|NCT01077128|O22|Outcome|EQ5D- Anxiety/Depression- Month 1|All eligible patients with psoriasis treated with Adalimumab
237307|NCT01077128|O21|Outcome|EQ5D- Anxiety/Depression- Baseline|All eligible patients with psoriasis treated with Adalimumab
237308|NCT01077128|O20|Outcome|EQ5D- Pain/Discomfort- Month 12|All eligible patients with psoriasis treated with Adalimumab
237309|NCT01077128|O19|Outcome|EQ5D- Pain/Discomfort- Month 8|All eligible patients with psoriasis treated with Adalimumab
237310|NCT01077128|O18|Outcome|EQ5D- Pain/Discomfort- Month 4|All eligible patients with psoriasis treated with Adalimumab
237311|NCT01077128|O17|Outcome|EQ5D- Pain/Discomfort- Month 1|All eligible patients with psoriasis treated with Adalimumab
237312|NCT01077128|O16|Outcome|EQ5D- Pain/Discomfort- Baseline|All eligible patients with psoriasis treated with Adalimumab
237313|NCT01077128|O15|Outcome|EQ5D- Usual Activities- Month 12|All eligible patients with psoriasis treated with Adalimumab
237314|NCT01077128|O14|Outcome|EQ5D- Usual Activities- Month 8|All eligible patients with psoriasis treated with Adalimumab
237315|NCT01077128|O13|Outcome|EQ5D- Usual Activities- Month 4|All eligible patients with psoriasis treated with Adalimumab
237316|NCT01077128|O12|Outcome|EQ5D- Usual Activities- Month 1|All eligible patients with psoriasis treated with Adalimumab
237317|NCT01077128|O11|Outcome|EQ5D- Usual Activities- Baseline|All eligible patients with psoriasis treated with Adalimumab
237318|NCT01077128|O10|Outcome|EQ5D- Self-care- Month 12|All eligible patients with psoriasis treated with Adalimumab
237319|NCT01077128|O9|Outcome|EQ5D- Self-care- Month 8|All eligible patients with psoriasis treated with Adalimumab
237320|NCT01077128|O8|Outcome|EQ5D- Self-care- Month 4|All eligible patients with psoriasis treated with Adalimumab
237321|NCT01077128|O7|Outcome|EQ5D- Self-care- Month 1|All eligible patients with psoriasis treated with Adalimumab
237322|NCT01077128|O6|Outcome|EQ5D- Self-care- Baseline|All eligible patients with psoriasis treated with Adalimumab
237323|NCT01077128|O5|Outcome|EQ5D- Mobility- Month 12|All eligible patients with psoriasis treated with Adalimumab
237324|NCT01077128|O4|Outcome|EQ5D- Mobility- Month 8|All eligible patients with psoriasis treated with Adalimumab
237325|NCT01077128|O3|Outcome|EQ5D- Mobility- Month 4|All eligible patients with psoriasis treated with Adalimumab
237326|NCT01077128|O2|Outcome|EQ5D- Mobility- Month 1|All eligible patients with psoriasis treated with Adalimumab
237327|NCT01077128|O1|Outcome|EQ5D- Mobility- Baseline|All eligible patients with psoriasis treated with Adalimumab
237328|NCT01077128|O17|Outcome|DLQI Score Change Baseline to Month 12- West Macedonia|All eligible patients with psoriasis treated with Adalimumab
237329|NCT01077128|O16|Outcome|DLQI Score Change Baseline to Month 12- West Greece|All eligible patients with psoriasis treated with Adalimumab
237330|NCT01077128|O15|Outcome|DLQI Score Change Baseline to Month 12- Thessaly|All eligible patients with psoriasis treated with Adalimumab
237331|NCT01077128|O14|Outcome|DLQI Score Change Baseline to Month 12- South Aegean|All eligible patients with psoriasis treated with Adalimumab
237332|NCT01077128|O13|Outcome|DLQI Score Change Baseline to Month 12- Peloponnese|All eligible patients with psoriasis treated with Adalimumab
237333|NCT01077128|O12|Outcome|DLQI Score Change Baseline to Month 12- North Aegean|All eligible patients with psoriasis treated with Adalimumab
237334|NCT01077128|O11|Outcome|DLQI Score Change Baseline to Month 12- Ionian Islands|All eligible patients with psoriasis treated with Adalimumab
237335|NCT01077128|O10|Outcome|DLQI Score Change Baseline to Month 12- Epirus|All eligible patients with psoriasis treated with Adalimumab
237336|NCT01077128|O9|Outcome|DLQI Score Change Baseline to Month 12- East Macedonia/Thrace|All eligible patients with psoriasis treated with Adalimumab
237337|NCT01077128|O8|Outcome|DLQI Score Change Baseline to Month 12- Crete|All eligible patients with psoriasis treated with Adalimumab
237338|NCT01077128|O7|Outcome|DLQI Score Change Baseline to Month 12- Central Macedonia|All eligible patients with psoriasis treated with Adalimumab
237339|NCT01077128|O6|Outcome|DLQI Score Change Baseline to Month 12- Central Greece|All eligible patients with psoriasis treated with Adalimumab
237340|NCT01077128|O5|Outcome|DLQI Score Change Baseline to Month 12- Attica|All eligible patients with psoriasis treated with Adalimumab
237341|NCT01077128|O4|Outcome|DLQI Score Change by PGA Response Group- Month 12|All eligible patients with psoriasis treated with Adalimumab
237342|NCT01077128|O3|Outcome|DLQI Score Change by PGA Response Group- Month 8|All eligible patients with psoriasis treated with Adalimumab
237343|NCT01077128|O2|Outcome|DLQI Score Change by PGA Response Group- Month 4|All eligible patients with psoriasis treated with Adalimumab
237344|NCT01077128|O1|Outcome|DLQI Score Change by PGA Response Group- Month 1|All eligible patients with psoriasis treated with Adalimumab
237345|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
237346|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
237347|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
237348|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
237349|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
237350|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
237351|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
237352|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
237353|NCT01077128|E1|Reported Event|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
237354|NCT01077076|B1|Baseline|Entire Study Population|
238256|NCT01074502|E1|Reported Event|Apremilast|apremilast 20 mgs twice a day for 12 weeks
237355|NCT01077076|P6|Participant Flow|Placebo/Prilosec/Zegerid|Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
237356|NCT01077076|P5|Participant Flow|Placebo/Zegerid/Prilosec|Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
237357|NCT01077076|P4|Participant Flow|Prilosec/Placebo/Zegerid|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
237358|NCT01077076|P3|Participant Flow|Prilosec/Zegerid/Placebo|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
237359|NCT01077076|P2|Participant Flow|Zegerid/Placebo/Prilosec|Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
237360|NCT01077076|P1|Participant Flow|Zegerid/Prilosec/Placebo|Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
237361|NCT01077076|O3|Outcome|Placebo Capsules|
237362|NCT01077076|O2|Outcome|Prilosec OTC Tablets|20 mg-equivalent omeprazole
237363|NCT01077076|O1|Outcome|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
237364|NCT01077076|E3|Reported Event|Placebo Capsules|
237365|NCT01077076|E2|Reported Event|Prilosec OTC Tablets|20 mg-equivalent omeprazole
237366|NCT01077076|E1|Reported Event|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
237367|NCT01077063|B3|Baseline|Total|Total of all reporting groups
237368|NCT01077063|B2|Baseline|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
237369|NCT01077063|B1|Baseline|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
237370|NCT01077063|P2|Participant Flow|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
237371|NCT01077063|P1|Participant Flow|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
237372|NCT01077063|O2|Outcome|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
237373|NCT01077063|O1|Outcome|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
237374|NCT01077063|E2|Reported Event|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
237375|NCT01077063|E1|Reported Event|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
237376|NCT01077050|B1|Baseline|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
237377|NCT01077050|P1|Participant Flow|Only One Arm in the Study, Thus Not Applicable.|
237378|NCT01077050|O1|Outcome|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
237379|NCT01077050|E1|Reported Event|Biopsied Skin Lesions|"Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).~Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects."
237380|NCT01077024|B3|Baseline|Total|Total of all reporting groups
237381|NCT01077024|B2|Baseline|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237382|NCT01077024|B1|Baseline|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237383|NCT01077024|P2|Participant Flow|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237384|NCT01077024|P1|Participant Flow|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237385|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237386|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237437|NCT01076959|O1|Outcome|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
237387|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237388|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237389|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237390|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237391|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237392|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237393|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237394|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237395|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237396|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237397|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237398|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237399|NCT01077024|E2|Reported Event|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
237400|NCT01077024|E1|Reported Event|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
237401|NCT01076985|B1|Baseline|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237402|NCT01076985|P1|Participant Flow|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237403|NCT01076985|O2|Outcome|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
237404|NCT01076985|O1|Outcome|Lopinavir/Ritonavir|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237405|NCT01076985|E2|Reported Event|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
237406|NCT01076985|E1|Reported Event|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237407|NCT01076972|B1|Baseline|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237408|NCT01076972|P1|Participant Flow|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237409|NCT01076972|O7|Outcome|Lopinavir/Ritonavir: Baseline Category Unknown|The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
237410|NCT01076972|O6|Outcome|Lopinavir/Ritonavir: Baseline Category P-2|The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
237475|NCT01076452|B3|Baseline|Total|Total of all reporting groups
237411|NCT01076972|O5|Outcome|Lopinavir/Ritonavir: Baseline Category P-1|The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
237412|NCT01076972|O4|Outcome|Lopinavir/Ritonavir: Baseline Category P-0|The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
237413|NCT01076972|O3|Outcome|Lopinavir/Ritonavir: Baseline Category C|The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
237414|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Baseline Category B|The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
237415|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Baseline Category A|The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
237416|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
237417|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
237418|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-Experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
237419|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
237420|NCT01076972|O1|Outcome|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237421|NCT01076972|E1|Reported Event|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
237422|NCT01076959|B1|Baseline|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
237423|NCT01076959|P1|Participant Flow|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
237424|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good and Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
237425|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
237426|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
237427|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
237428|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
237429|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
237430|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
237431|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
237432|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
237433|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
237434|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
237435|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
237436|NCT01076959|O1|Outcome|Physician Response Rating|The full analysis set was used to determine the physicians' overall response rating.
237590|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
237438|NCT01076959|E1|Reported Event|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
237439|NCT01076686|B5|Baseline|Total|Total of all reporting groups
237440|NCT01076686|B4|Baseline|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237441|NCT01076686|B3|Baseline|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
237442|NCT01076686|B2|Baseline|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237443|NCT01076686|B1|Baseline|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237444|NCT01076686|P4|Participant Flow|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237445|NCT01076686|P3|Participant Flow|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
237446|NCT01076686|P2|Participant Flow|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237447|NCT01076686|P1|Participant Flow|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237448|NCT01076686|O4|Outcome|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237449|NCT01076686|O3|Outcome|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
237450|NCT01076686|O2|Outcome|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237451|NCT01076686|O1|Outcome|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237452|NCT01076686|E4|Reported Event|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237453|NCT01076686|E3|Reported Event|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
237454|NCT01076686|E2|Reported Event|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237455|NCT01076686|E1|Reported Event|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
237456|NCT01076647|B3|Baseline|Total|Total of all reporting groups
237457|NCT01076647|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237458|NCT01076647|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237459|NCT01076647|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237460|NCT01076647|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237461|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237462|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237463|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237464|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237465|NCT01076647|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237466|NCT01076647|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
237467|NCT01076504|B1|Baseline|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237468|NCT01076504|P1|Participant Flow|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237469|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237470|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237471|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237472|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237473|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237474|NCT01076504|E1|Reported Event|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
237476|NCT01076452|B2|Baseline|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237477|NCT01076452|B1|Baseline|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237478|NCT01076452|P2|Participant Flow|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237479|NCT01076452|P1|Participant Flow|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237480|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237481|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237482|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237483|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237484|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237485|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237486|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237487|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237488|NCT01076452|E2|Reported Event|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237489|NCT01076452|E1|Reported Event|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
237490|NCT01076361|B1|Baseline|All Enrolled Patients|All patients who were enrolled and implanted with a Model 4968 Lead
237491|NCT01076361|P1|Participant Flow|Model 4968 Leads|A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
237492|NCT01076361|O1|Outcome|Model 4968 Lead Survival Probability|Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
237493|NCT01076361|E1|Reported Event|Model 4968 Participants|All Model 4968 participants in the analysis cohort
237494|NCT01076348|B1|Baseline|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
237495|NCT01076348|P1|Participant Flow|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
237496|NCT01076348|O1|Outcome|Medtronic 4965 Epicardial Lead|Subjects who were implanted with at least 1 model 4965 lead.
237497|NCT01076348|E1|Reported Event|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
237498|NCT01076335|B1|Baseline|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
237499|NCT01076335|P1|Participant Flow|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
237500|NCT01076335|O1|Outcome|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
237501|NCT01076335|E1|Reported Event|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
237502|NCT01076296|B1|Baseline|Total for All Groups Assessed|Subjects assessed for LV function using both VScan and a clinical examination.
237503|NCT01076296|P8|Participant Flow|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
237504|NCT01076296|P7|Participant Flow|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
237505|NCT01076296|P6|Participant Flow|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
237506|NCT01076296|P5|Participant Flow|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
237507|NCT01076296|P4|Participant Flow|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
237508|NCT01076296|P3|Participant Flow|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
237509|NCT01076296|P2|Participant Flow|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
237591|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
237510|NCT01076296|P1|Participant Flow|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
237511|NCT01076296|O8|Outcome|No Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
237512|NCT01076296|O7|Outcome|Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
237513|NCT01076296|O6|Outcome|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
237514|NCT01076296|O5|Outcome|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
237515|NCT01076296|O4|Outcome|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
237516|NCT01076296|O3|Outcome|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
237517|NCT01076296|O2|Outcome|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
237518|NCT01076296|O1|Outcome|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
237519|NCT01076296|E8|Reported Event|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
237520|NCT01076296|E7|Reported Event|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
237521|NCT01076296|E6|Reported Event|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
237522|NCT01076296|E5|Reported Event|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
237523|NCT01076296|E4|Reported Event|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
237524|NCT01076296|E3|Reported Event|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
237525|NCT01076296|E2|Reported Event|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
237526|NCT01076296|E1|Reported Event|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
237527|NCT01076283|B3|Baseline|Total|Total of all reporting groups
237528|NCT01076283|B2|Baseline|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
237529|NCT01076283|B1|Baseline|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
237530|NCT01076283|P2|Participant Flow|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
237531|NCT01076283|P1|Participant Flow|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
237532|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
237533|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
237534|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
237535|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
237536|NCT01076283|E2|Reported Event|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
237537|NCT01076283|E1|Reported Event|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
237538|NCT01076244|B1|Baseline|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237539|NCT01076244|P1|Participant Flow|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237540|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237541|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237542|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237543|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237544|NCT01076244|E1|Reported Event|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
237545|NCT01076192|B1|Baseline|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237546|NCT01076192|P1|Participant Flow|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237547|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice
237548|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237549|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
238257|NCT01074463|B3|Baseline|Total|Total of all reporting groups
237550|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237551|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237552|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237553|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237554|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237555|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237556|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237557|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237558|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237559|NCT01076192|E1|Reported Event|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
237560|NCT01076166|B1|Baseline|Klacid Granules (Total)|The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
237561|NCT01076166|P1|Participant Flow|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
237562|NCT01076166|O1|Outcome|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
237563|NCT01076166|O3|Outcome|Klacid Granules (Pneumonia, Recovered)|Participants in the recovered population who had a diagnosis of pneumonia at study entry.
237564|NCT01076166|O2|Outcome|Klacid Granules (Bronchitis, Recovered)|Participants in the recovered population who had a diagnosis of bronchitis at study entry.
237565|NCT01076166|O1|Outcome|Klacid Granules (Total Number Recovered)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.
237566|NCT01076166|E1|Reported Event|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
237567|NCT01076153|B1|Baseline|Klacid MR|The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
237568|NCT01076153|P1|Participant Flow|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
237569|NCT01076153|O1|Outcome|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
237570|NCT01076153|O4|Outcome|Klacid MR (URTI and LRTI, Recovered)|Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
237571|NCT01076153|O3|Outcome|Klacid MR (LRTI, Recovered)|Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
237572|NCT01076153|O2|Outcome|Klacid MR (URTI, Recovered)|Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
237573|NCT01076153|O1|Outcome|Klacid MR (Total Number Recovered)|Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
237574|NCT01076153|E1|Reported Event|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
237575|NCT01076088|B7|Baseline|Total|Total of all reporting groups
237576|NCT01076088|B6|Baseline|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
237577|NCT01076088|B5|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237578|NCT01076088|B4|Baseline|Metformin 850|Metformin 850 mg twice daily
237579|NCT01076088|B3|Baseline|Metformin 500 mg|Metformin 500 mg twice daily
237580|NCT01076088|B2|Baseline|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237581|NCT01076088|B1|Baseline|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237582|NCT01076088|P6|Participant Flow|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
237583|NCT01076088|P5|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237584|NCT01076088|P4|Participant Flow|Metformin 850|Metformin 850 mg twice daily
237585|NCT01076088|P3|Participant Flow|Metformin 500 mg|Metformin 500 mg twice daily
237586|NCT01076088|P2|Participant Flow|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237587|NCT01076088|P1|Participant Flow|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237588|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
237589|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237592|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237593|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237594|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
237595|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237596|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
237597|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
237598|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237599|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237600|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
237601|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237602|NCT01076088|O4|Outcome|Metformin 850 mg|Metformin 850 mg twice daily
237603|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
237604|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237605|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237606|NCT01076088|E6|Reported Event|Placebo|Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.
237607|NCT01076088|E5|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
237608|NCT01076088|E4|Reported Event|Metformin 850|Metformin 850 mg twice daily
237609|NCT01076088|E3|Reported Event|Metformin 500 mg|Metformin 500 mg twice daily
237610|NCT01076088|E2|Reported Event|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
237611|NCT01076088|E1|Reported Event|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
237612|NCT01076075|B3|Baseline|Total|Total of all reporting groups
237613|NCT01076075|B2|Baseline|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
237614|NCT01076075|B1|Baseline|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
237615|NCT01076075|P2|Participant Flow|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
237616|NCT01076075|P1|Participant Flow|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
237617|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
237618|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
237619|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
237620|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
237621|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
237622|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
237623|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
237624|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
237625|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
237626|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg
237627|NCT01076075|E2|Reported Event|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
237628|NCT01076075|E1|Reported Event|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
237629|NCT01076036|B1|Baseline|Investigational|CorPath® 200 System
237630|NCT01076036|P1|Participant Flow|Group 1|Group 1 was treated using the CorPath device.
237631|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
237632|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
237633|NCT01076036|E1|Reported Event|Investigational|CorPath® 200 System
237634|NCT01075984|B6|Baseline|Total|Total of all reporting groups
237635|NCT01075984|B5|Baseline|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237636|NCT01075984|B4|Baseline|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237637|NCT01075984|B3|Baseline|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237638|NCT01075984|B2|Baseline|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237639|NCT01075984|B1|Baseline|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237640|NCT01075984|P5|Participant Flow|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
238099|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
237641|NCT01075984|P4|Participant Flow|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237642|NCT01075984|P3|Participant Flow|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237643|NCT01075984|P2|Participant Flow|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237644|NCT01075984|P1|Participant Flow|Posaconazole (POS) 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237645|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237646|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237647|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237648|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237649|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237650|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237651|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237652|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237653|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237654|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237655|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237656|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237657|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237658|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237659|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237660|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237661|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237662|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237663|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237664|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237665|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237666|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237667|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237668|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
249275|NCT01037244|O4|Outcome|Placebo|Placebo tablets
237669|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237670|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237671|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237672|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237673|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237674|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237675|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237676|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237677|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237678|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237679|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237680|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237681|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237682|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237683|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237684|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237685|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237686|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237687|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237688|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237689|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237690|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237691|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
237692|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237693|NCT01075984|E4|Reported Event|POS 300 mg IV BID (Cohort 2 and 3)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
237694|NCT01075984|E3|Reported Event|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
238100|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
237695|NCT01075984|E2|Reported Event|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237696|NCT01075984|E1|Reported Event|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
237697|NCT01075971|B1|Baseline|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
237698|NCT01075971|P1|Participant Flow|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
237699|NCT01075971|O1|Outcome|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
237700|NCT01075971|E1|Reported Event|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
237701|NCT01075958|B1|Baseline|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
237702|NCT01075958|P1|Participant Flow|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
237703|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237704|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237705|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237706|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237707|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237708|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237709|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237710|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237711|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237712|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237713|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
237714|NCT01075958|E1|Reported Event|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
237715|NCT01075815|B3|Baseline|Total|Total of all reporting groups
237716|NCT01075815|B2|Baseline|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237717|NCT01075815|B1|Baseline|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237718|NCT01075815|P2|Participant Flow|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237719|NCT01075815|P1|Participant Flow|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237720|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237721|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237722|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237723|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237724|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237725|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237726|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237727|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237728|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
238101|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
237729|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237730|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237731|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237732|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237733|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237734|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237735|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237736|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237737|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237738|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237739|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237740|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237741|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237742|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237743|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237744|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237745|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237746|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237747|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237748|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237749|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237750|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237751|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237752|NCT01075815|E2|Reported Event|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
237753|NCT01075815|E1|Reported Event|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
237754|NCT01075763|B3|Baseline|Total|Total of all reporting groups
237755|NCT01075763|B2|Baseline|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237756|NCT01075763|B1|Baseline|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237757|NCT01075763|P2|Participant Flow|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237758|NCT01075763|P1|Participant Flow|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237759|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237760|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237761|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237762|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237763|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237764|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237765|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237766|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237767|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237768|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237769|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237770|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237771|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237772|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237773|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237774|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237775|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
238102|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
237776|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237777|NCT01075763|E2|Reported Event|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
237778|NCT01075763|E1|Reported Event|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
237779|NCT01075685|B3|Baseline|Total|Total of all reporting groups
237780|NCT01075685|B2|Baseline|Minimum Information|
237781|NCT01075685|B1|Baseline|Web-based Alcohol Programme|
237782|NCT01075685|P2|Participant Flow|Minimum Information|
237783|NCT01075685|P1|Participant Flow|Web-based Alcohol Programme|
237784|NCT01075685|O2|Outcome|Minimum Information|
237785|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
237786|NCT01075685|O2|Outcome|Minimum Information|
237787|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
237788|NCT01075685|O2|Outcome|Minimum Information|
237789|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
237790|NCT01075685|O2|Outcome|Minimum Information|
237791|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
237792|NCT01075685|E2|Reported Event|Minimum Information|
237793|NCT01075685|E1|Reported Event|Web-based Alcohol Programme|
237794|NCT01075646|B5|Baseline|Total|Total of all reporting groups
237795|NCT01075646|B4|Baseline|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237796|NCT01075646|B3|Baseline|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237797|NCT01075646|B2|Baseline|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237798|NCT01075646|B1|Baseline|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237799|NCT01075646|P4|Participant Flow|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237800|NCT01075646|P3|Participant Flow|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237801|NCT01075646|P2|Participant Flow|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237802|NCT01075646|P1|Participant Flow|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237803|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237804|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237805|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237806|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237807|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237938|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237808|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237809|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237810|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237811|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237812|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237813|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237814|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237815|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237816|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237817|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237818|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237819|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237820|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237821|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237822|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237823|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237824|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237825|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237855|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
249276|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
237826|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237827|NCT01075646|E4|Reported Event|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
237828|NCT01075646|E3|Reported Event|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
237829|NCT01075646|E2|Reported Event|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
237830|NCT01075646|E1|Reported Event|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
237831|NCT01075399|B1|Baseline|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
237832|NCT01075399|P1|Participant Flow|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
237833|NCT01075399|O1|Outcome|Subjects That Received 1st and 2nd [F18] HX4 Scans|Single arm study. This group includes all subjects that successfully received [F18]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
237834|NCT01075399|E1|Reported Event|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
237835|NCT01075347|B3|Baseline|Total|Total of all reporting groups
237836|NCT01075347|B2|Baseline|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
237837|NCT01075347|B1|Baseline|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
237838|NCT01075347|P2|Participant Flow|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
237839|NCT01075347|P1|Participant Flow|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
237840|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
237841|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
237842|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
237843|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
237844|NCT01075347|E2|Reported Event|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
237845|NCT01075347|E1|Reported Event|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
237846|NCT01075282|B4|Baseline|Total|Total of all reporting groups
237847|NCT01075282|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237848|NCT01075282|B2|Baseline|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237849|NCT01075282|B1|Baseline|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237850|NCT01075282|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237851|NCT01075282|P2|Participant Flow|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237852|NCT01075282|P1|Participant Flow|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237853|NCT01075282|O1|Outcome|LY2189265 1.5 mg and 0.75 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237854|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237856|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237857|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237858|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237859|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237860|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237861|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237862|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237863|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237864|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237865|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237866|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237867|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237868|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237869|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237870|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237871|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237872|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237873|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237874|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237875|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237876|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237877|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237878|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237879|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237880|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237881|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237882|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237883|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237884|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237885|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237886|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237887|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237888|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237889|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237890|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237891|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237892|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237893|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237894|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237895|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237896|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237897|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237898|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237899|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237900|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237901|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237902|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237903|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237904|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237905|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237906|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237907|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237908|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237909|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237910|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237911|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237912|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237913|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237914|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237915|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237916|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237917|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237918|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237919|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237920|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237921|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237922|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237923|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237924|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237925|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237926|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237927|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237928|NCT01075282|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237929|NCT01075282|E2|Reported Event|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237930|NCT01075282|E1|Reported Event|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
237931|NCT01075256|B4|Baseline|Total|Total of all reporting groups
237932|NCT01075256|B3|Baseline|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237933|NCT01075256|B2|Baseline|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237934|NCT01075256|B1|Baseline|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237935|NCT01075256|P3|Participant Flow|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237936|NCT01075256|P2|Participant Flow|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237937|NCT01075256|P1|Participant Flow|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
249277|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
237939|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237940|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237941|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237942|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237943|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237944|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237945|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237946|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237947|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.
237948|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237949|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237950|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237951|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237952|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237953|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237954|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237955|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237956|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237957|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237958|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237959|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237960|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237961|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237962|NCT01075256|E3|Reported Event|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
237963|NCT01075256|E2|Reported Event|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237964|NCT01075256|E1|Reported Event|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
237965|NCT01075243|B4|Baseline|Total|Total of all reporting groups
237966|NCT01075243|B3|Baseline|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237967|NCT01075243|B2|Baseline|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237968|NCT01075243|B1|Baseline|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
237969|NCT01075243|P3|Participant Flow|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237970|NCT01075243|P2|Participant Flow|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237971|NCT01075243|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route.
237972|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237973|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237974|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
237975|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237976|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237977|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
237978|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237979|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237980|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
237981|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237982|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237983|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
237984|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237985|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237986|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
237987|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237988|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237989|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
237990|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237991|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237992|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
237993|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237994|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237995|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
237996|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
237997|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
237998|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
237999|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238000|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238001|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
238002|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238003|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238097|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238004|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
238005|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238006|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238007|NCT01075243|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
238008|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238009|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238010|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
238011|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238012|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238013|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
238014|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238015|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238016|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
238017|NCT01075243|E3|Reported Event|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
238018|NCT01075243|E2|Reported Event|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
238019|NCT01075243|E1|Reported Event|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
238020|NCT01075217|B3|Baseline|Total|Total of all reporting groups
238021|NCT01075217|B2|Baseline|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238022|NCT01075217|B1|Baseline|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238023|NCT01075217|P2|Participant Flow|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238024|NCT01075217|P1|Participant Flow|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238025|NCT01075217|O2|Outcome|Visipaque 270 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238026|NCT01075217|O1|Outcome|Isovue 250 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238027|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238028|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238029|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238030|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238031|NCT01075217|O2|Outcome|Visipaque 270 VAS Score Immedicately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238032|NCT01075217|O1|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238033|NCT01075217|O4|Outcome|Visipaque 270 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238034|NCT01075217|O3|Outcome|Visipaque 270 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238035|NCT01075217|O2|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238036|NCT01075217|O1|Outcome|Isovue 250 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238037|NCT01075217|E2|Reported Event|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238038|NCT01075217|E1|Reported Event|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
238039|NCT01075204|B1|Baseline|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238040|NCT01075204|P1|Participant Flow|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238041|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238042|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238043|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238044|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238045|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238046|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238047|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238048|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238049|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238050|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238051|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238052|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238053|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238054|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238055|NCT01075204|E1|Reported Event|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
238098|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238056|NCT01075191|B1|Baseline|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238057|NCT01075191|P1|Participant Flow|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238058|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238059|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238060|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238061|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238062|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238063|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
238064|NCT01075191|E1|Reported Event|HIV-infected Participants|"HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).~Safety data presents all enrolled participants, including 5 protocol violations."
238065|NCT01075178|B3|Baseline|Total|Total of all reporting groups
238066|NCT01075178|B2|Baseline|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238067|NCT01075178|B1|Baseline|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238068|NCT01075178|P2|Participant Flow|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238069|NCT01075178|P1|Participant Flow|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238070|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238071|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238072|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238073|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238074|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238075|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238076|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238077|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238078|NCT01075178|E2|Reported Event|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
238079|NCT01075178|E1|Reported Event|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
238080|NCT01075152|B3|Baseline|Total|Total of all reporting groups
238081|NCT01075152|B2|Baseline|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week)
238082|NCT01075152|B1|Baseline|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis.
238083|NCT01075152|P2|Participant Flow|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week)
238084|NCT01075152|P1|Participant Flow|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal diagnosis
238085|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238086|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238087|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238088|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238089|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238090|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238091|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238092|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis]
238093|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238094|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238095|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238096|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238103|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week).
238104|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238105|NCT01075152|E2|Reported Event|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
238106|NCT01075152|E1|Reported Event|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
238107|NCT01075100|B3|Baseline|Total|Total of all reporting groups
238108|NCT01075100|B2|Baseline|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238109|NCT01075100|B1|Baseline|Triple Negative|ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238110|NCT01075100|P2|Participant Flow|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238111|NCT01075100|P1|Participant Flow|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238112|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238113|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238114|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238115|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238116|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238117|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238118|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238119|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238120|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238121|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238122|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238123|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238124|NCT01075100|E2|Reported Event|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238125|NCT01075100|E1|Reported Event|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
238126|NCT01075087|B3|Baseline|Total|Total of all reporting groups
238127|NCT01075087|B2|Baseline|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
238128|NCT01075087|B1|Baseline|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
238129|NCT01075087|P2|Participant Flow|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
238130|NCT01075087|P1|Participant Flow|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
238131|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
238132|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
238133|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
238134|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
238135|NCT01075087|E2|Reported Event|Active Comparator|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
238136|NCT01075087|E1|Reported Event|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
238137|NCT01075074|B4|Baseline|Total|Total of all reporting groups
238138|NCT01075074|B3|Baseline|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
238139|NCT01075074|B2|Baseline|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
249278|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
238140|NCT01075074|B1|Baseline|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
238141|NCT01075074|P3|Participant Flow|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
238142|NCT01075074|P2|Participant Flow|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
238143|NCT01075074|P1|Participant Flow|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
238144|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
238145|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
238146|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
238147|NCT01075074|O3|Outcome|Ropivacaine 0.25%|Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
238148|NCT01075074|O2|Outcome|Normal Saline|Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
238149|NCT01075074|O1|Outcome|Ropivacaine 0.5%|Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
238150|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
238151|NCT01075074|O2|Outcome|Normal Saline|The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
238152|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
238153|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
238154|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
238155|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
238156|NCT01075074|E3|Reported Event|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
238157|NCT01075074|E2|Reported Event|Normal Saline|Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
238158|NCT01075074|E1|Reported Event|Ropivacaine 0.5%|Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine
238159|NCT01074944|B1|Baseline|All Participants|All participants who received treatment in LIP (eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks [except for the participants in Japan]. Participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks) and assessed for randomization.
238160|NCT01074944|P5|Participant Flow|ETP, Eliglustat|All participants who did not meet all the randomization criteria at Week 78 of the LIP continued in the ETP and received eliglustat capsules at the same dose as they were receiving at the end of LIP till the end of the study.
238161|NCT01074944|P4|Participant Flow|LTTP, Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238162|NCT01074944|P3|Participant Flow|PAP, Eliglustat: Twice Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP, received eliglustat at the TDD 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238163|NCT01074944|P2|Participant Flow|PAP, Eliglustat: Once Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP received eliglustat capsules at the total daily dose (TDD) of 100 mg or 200 mg (the TDD they were on before randomization) once daily (QD) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238164|NCT01074944|P1|Participant Flow|LIP, Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual pharmacokinetics (PK) data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238356|NCT01074229|B1|Baseline|Placebo|Group B (control group) will receive sterile normal saline.
238165|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238166|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238167|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238168|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238169|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238170|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238171|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238184|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238210|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238172|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238173|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238174|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238175|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
238176|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238177|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238178|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238179|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238180|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238181|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238182|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238183|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238252|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
238185|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
238186|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238187|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238188|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238189|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238190|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238191|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238192|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238193|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238194|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238195|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238196|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238197|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238198|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238199|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238200|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238201|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238202|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238203|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238204|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238205|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238206|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238207|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238208|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238209|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
249279|NCT01037244|O4|Outcome|Placebo|Placebo tablets
238211|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238212|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238213|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238214|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238215|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
238216|NCT01074944|E1|Reported Event|Eliglustat|All participants who received eliglustat at the TDD of 100 mg or 200 mg in the LIP, PAP, LTTP or ETP.
238217|NCT01074931|B1|Baseline|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238218|NCT01074931|P1|Participant Flow|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238219|NCT01074931|O2|Outcome|Lopinavir/Ritonavir Group: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
238220|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
238221|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238222|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238223|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238224|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
238225|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
238226|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
238227|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
238228|NCT01074931|E1|Reported Event|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
238229|NCT01074658|B1|Baseline|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
238230|NCT01074658|P1|Participant Flow|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
238231|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
238232|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
238233|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
238234|NCT01074658|E1|Reported Event|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
238235|NCT01074554|B3|Baseline|Total|Total of all reporting groups
238236|NCT01074554|B2|Baseline|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
238237|NCT01074554|B1|Baseline|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
238238|NCT01074554|P2|Participant Flow|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
238239|NCT01074554|P1|Participant Flow|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
238240|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
238241|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
238242|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
238243|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
238244|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
238245|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
238246|NCT01074554|E2|Reported Event|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
238247|NCT01074554|E1|Reported Event|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
238248|NCT01074502|B1|Baseline|Apremilast|apremilast 20 mgs twice a day for 12 weeks
238249|NCT01074502|P1|Participant Flow|Apremilast|apremilast 20 mgs twice a day for 12 weeks
238250|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
238251|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
238258|NCT01074463|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238259|NCT01074463|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238260|NCT01074463|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238261|NCT01074463|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238262|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238263|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238264|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238265|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238266|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238267|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238268|NCT01074463|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238269|NCT01074463|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238270|NCT01074450|B3|Baseline|Total|Total of all reporting groups
238271|NCT01074450|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238272|NCT01074450|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238273|NCT01074450|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238274|NCT01074450|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238275|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238276|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238277|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238278|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238279|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
238280|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
238281|NCT01074450|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
238282|NCT01074450|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
238283|NCT01074437|B3|Baseline|Total|Total of all reporting groups
238284|NCT01074437|B2|Baseline|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
238285|NCT01074437|B1|Baseline|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
238286|NCT01074437|P2|Participant Flow|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
238287|NCT01074437|P1|Participant Flow|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
238288|NCT01074437|O2|Outcome|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
238289|NCT01074437|O1|Outcome|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
238290|NCT01074437|E2|Reported Event|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
238291|NCT01074437|E1|Reported Event|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
238292|NCT01074307|B3|Baseline|Total|Total of all reporting groups
238293|NCT01074307|B2|Baseline|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238294|NCT01074307|B1|Baseline|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238295|NCT01074307|P2|Participant Flow|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238296|NCT01074307|P1|Participant Flow|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238297|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238298|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238299|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238300|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238301|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238302|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238303|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238304|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238325|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
239157|NCT01072201|E1|Reported Event|Total Toothpaste|Triclosan/copolymer/Fluoride
238305|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238306|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238307|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238308|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238309|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238310|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238311|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238312|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238313|NCT01074307|E2|Reported Event|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238314|NCT01074307|E1|Reported Event|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
238315|NCT01074268|B3|Baseline|Total|Total of all reporting groups
238316|NCT01074268|B2|Baseline|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238317|NCT01074268|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238318|NCT01074268|P2|Participant Flow|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238319|NCT01074268|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238320|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238321|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238322|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238323|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238324|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
239158|NCT01072188|B3|Baseline|Total|Total of all reporting groups
238326|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238327|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238328|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238329|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238330|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238331|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238332|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238333|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238334|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238335|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238336|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238337|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238338|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238339|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238340|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238341|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238342|NCT01074268|E2|Reported Event|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238343|NCT01074268|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
238344|NCT01074255|B1|Baseline|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
238345|NCT01074255|P1|Participant Flow|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
238346|NCT01074255|O1|Outcome|Participants Treated With EMEND|
238347|NCT01074255|E1|Reported Event|Participants in the Safety Analysis|Participants included in the Safety Analysis
238348|NCT01074242|B1|Baseline|Rotateq|Korean infants vaccinated with Rotateq in usual practice
238349|NCT01074242|P1|Participant Flow|Rotateq|Korean infants vaccinated with Rotateq in usual practice
238350|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
238351|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
238352|NCT01074242|E1|Reported Event|Rotateq|Korean infants vaccinated with Rotateq in usual practice
238353|NCT01074229|B4|Baseline|Total|Total of all reporting groups
238354|NCT01074229|B3|Baseline|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
238355|NCT01074229|B2|Baseline|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
238357|NCT01074229|P3|Participant Flow|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
238358|NCT01074229|P2|Participant Flow|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
238359|NCT01074229|P1|Participant Flow|Placebo|Group B (control group) will receive sterile normal saline.
238360|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
238361|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
238362|NCT01074229|O1|Outcome|Placebo|Group B (control group) will receive sterile normal saline.
238363|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
238364|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
238365|NCT01074229|O1|Outcome|PLACEBO|Group B (control group) will receive sterile normal saline.
238366|NCT01074229|E3|Reported Event|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
238367|NCT01074229|E2|Reported Event|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
238368|NCT01074229|E1|Reported Event|Placebo|Group B (control group) will receive sterile normal saline.
238369|NCT01074216|B1|Baseline|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
238370|NCT01074216|P1|Participant Flow|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
238371|NCT01074216|O1|Outcome|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
238372|NCT01074216|E1|Reported Event|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
238373|NCT01074164|B3|Baseline|Total|Total of all reporting groups
238374|NCT01074164|B2|Baseline|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238375|NCT01074164|B1|Baseline|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238376|NCT01074164|P2|Participant Flow|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238377|NCT01074164|P1|Participant Flow|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238378|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238379|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238380|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238381|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238382|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238383|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238384|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238385|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238386|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238387|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238388|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238389|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238390|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238391|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238392|NCT01074164|E2|Reported Event|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
238393|NCT01074164|E1|Reported Event|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
238394|NCT01074125|B4|Baseline|Total|Total of all reporting groups
238395|NCT01074125|B3|Baseline|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238396|NCT01074125|B2|Baseline|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238397|NCT01074125|B1|Baseline|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238398|NCT01074125|P3|Participant Flow|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238399|NCT01074125|P2|Participant Flow|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238400|NCT01074125|P1|Participant Flow|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238401|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238402|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238403|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238404|NCT01074125|O3|Outcome|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238405|NCT01074125|O2|Outcome|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238406|NCT01074125|O1|Outcome|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
238407|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238408|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238409|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
238410|NCT01074125|E3|Reported Event|8g/Day|Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
238411|NCT01074125|E2|Reported Event|6g/Day|Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
238412|NCT01074125|E1|Reported Event|1g/Day|Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
238413|NCT01074099|B3|Baseline|Total|Total of all reporting groups
238414|NCT01074099|B2|Baseline|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
238415|NCT01074099|B1|Baseline|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
238416|NCT01074099|P2|Participant Flow|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
238417|NCT01074099|P1|Participant Flow|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
238418|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
238419|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
238420|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
238421|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
238422|NCT01074099|E2|Reported Event|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
238423|NCT01074099|E1|Reported Event|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
238424|NCT01074047|B3|Baseline|Total|Total of all reporting groups
238436|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238448|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
239159|NCT01072188|B2|Baseline|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
238425|NCT01074047|B2|Baseline|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed.~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238426|NCT01074047|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238427|NCT01074047|P2|Participant Flow|Conventional Care Regimens (CCR)|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238428|NCT01074047|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physicians discretion.
238429|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238430|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238431|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238432|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238433|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238434|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238435|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238437|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238438|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238439|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238440|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238441|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238442|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238443|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238444|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238445|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238446|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238447|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
239459|NCT01071798|B1|Baseline|Main Analysis Set|Participants who received at least one cycle of rituximab
238449|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238450|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238451|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238452|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238453|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238454|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238455|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238456|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238457|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238458|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238459|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
239595|NCT01071083|B5|Baseline|Methylprednisolone|1000 mg intravenous every 4 weeks
238460|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238461|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238462|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238463|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238464|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238465|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238466|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238467|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238468|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238469|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238470|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238494|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238512|NCT01074008|P6|Participant Flow|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238471|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238472|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238473|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238474|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238475|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238476|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238477|NCT01074047|O4|Outcome|Conventional Care Regimen #1 Intensive Chemotherapy|Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
238478|NCT01074047|O3|Outcome|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
238479|NCT01074047|O2|Outcome|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
238480|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physicians discretion.
238481|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238482|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238626|NCT01073943|B1|Baseline|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238685|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
238483|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238484|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238485|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238486|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238487|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238488|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238489|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238490|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238491|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
238492|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
238493|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
239596|NCT01071083|B4|Baseline|Glatiramer Acetate|20 mg subcutaneous once daily
238495|NCT01074047|E4|Reported Event|Conventional Care Regimen #1 Intensive Chemotherapy|"Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1).~Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion."
238496|NCT01074047|E3|Reported Event|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
238497|NCT01074047|E2|Reported Event|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
238498|NCT01074047|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
238499|NCT01074008|B10|Baseline|Total|Total of all reporting groups
238500|NCT01074008|B9|Baseline|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238501|NCT01074008|B8|Baseline|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238502|NCT01074008|B7|Baseline|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238503|NCT01074008|B6|Baseline|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238504|NCT01074008|B5|Baseline|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238505|NCT01074008|B4|Baseline|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238506|NCT01074008|B3|Baseline|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238507|NCT01074008|B2|Baseline|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238508|NCT01074008|B1|Baseline|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238509|NCT01074008|P9|Participant Flow|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238510|NCT01074008|P8|Participant Flow|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238511|NCT01074008|P7|Participant Flow|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238513|NCT01074008|P5|Participant Flow|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238514|NCT01074008|P4|Participant Flow|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238515|NCT01074008|P3|Participant Flow|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238516|NCT01074008|P2|Participant Flow|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238517|NCT01074008|P1|Participant Flow|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238518|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238519|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238520|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238521|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238522|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238523|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238524|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238525|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238526|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238527|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238528|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238686|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
238529|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238530|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238531|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238532|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238533|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238534|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238535|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238536|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238537|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238538|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238539|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238540|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238541|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238542|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238543|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238544|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238687|NCT01073865|E2|Reported Event|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
249280|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
238545|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238546|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238547|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238548|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238549|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238550|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238551|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238552|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238553|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238554|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238555|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238556|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238557|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238558|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238559|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238560|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238627|NCT01073943|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238561|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238562|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238563|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238564|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238565|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238566|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238567|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238568|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238569|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238570|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238571|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238572|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238573|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238574|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238575|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238576|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238628|NCT01073943|P1|Participant Flow|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238577|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238578|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238579|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238580|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238581|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238582|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238583|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238584|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238585|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238586|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238587|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238588|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238589|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238590|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238591|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238592|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
239145|NCT01072201|B3|Baseline|Total|Total of all reporting groups
238593|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238594|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238595|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238596|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238597|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238598|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238599|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238600|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238601|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238602|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238603|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238604|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238605|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238606|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238607|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238608|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238682|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
239146|NCT01072201|B2|Baseline|Ultrabrite Toothpaste|sodium fluoride control (placebo)
238609|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238610|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238611|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238612|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238613|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238614|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238615|NCT01074008|E9|Reported Event|Placebo + (pegIFN/RBV)|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238616|NCT01074008|E8|Reported Event|ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238617|NCT01074008|E7|Reported Event|ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238618|NCT01074008|E6|Reported Event|ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238619|NCT01074008|E5|Reported Event|ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238620|NCT01074008|E4|Reported Event|ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238621|NCT01074008|E3|Reported Event|ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238622|NCT01074008|E2|Reported Event|ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238623|NCT01074008|E1|Reported Event|ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
238624|NCT01073943|B3|Baseline|Total|Total of all reporting groups
238625|NCT01073943|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238683|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
238629|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238630|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238631|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238632|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238633|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238634|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238635|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238636|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238637|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238638|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238639|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238640|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238641|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238642|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238643|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238644|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238645|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238646|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238647|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238648|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238649|NCT01073943|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238650|NCT01073943|E1|Reported Event|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
238651|NCT01073930|B3|Baseline|Total|Total of all reporting groups
238652|NCT01073930|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238653|NCT01073930|B1|Baseline|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
238684|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
238654|NCT01073930|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238655|NCT01073930|P1|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238656|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238657|NCT01073930|O1|Outcome|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
238658|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238659|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238660|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238661|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238662|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238663|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238664|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238665|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238666|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238667|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238668|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238669|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238670|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238671|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238672|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238673|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
238674|NCT01073930|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
238675|NCT01073930|E1|Reported Event|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
238676|NCT01073865|B3|Baseline|Total|Total of all reporting groups
238677|NCT01073865|B2|Baseline|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
238678|NCT01073865|B1|Baseline|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
238679|NCT01073865|P2|Participant Flow|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
238680|NCT01073865|P1|Participant Flow|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
238681|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
238688|NCT01073865|E1|Reported Event|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
238689|NCT01073657|B3|Baseline|Total|Total of all reporting groups
238690|NCT01073657|B2|Baseline|Active Control|Veterans recived peer services that did not address educational goals
238691|NCT01073657|B1|Baseline|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
238692|NCT01073657|P2|Participant Flow|General Peer Support|Veterans received peer services that did not address educational goals
238693|NCT01073657|P1|Participant Flow|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals
238694|NCT01073657|O2|Outcome|General Peer Support|Matched peer attention no supported education service
238695|NCT01073657|O1|Outcome|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group
238696|NCT01073657|E2|Reported Event|Active Control|Veterans received matched peer attention that did not address educational goals
238697|NCT01073657|E1|Reported Event|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
238698|NCT01073631|B1|Baseline|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
238699|NCT01073631|P1|Participant Flow|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
238700|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
238701|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
238702|NCT01073631|E1|Reported Event|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
238703|NCT01073618|B1|Baseline|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
238704|NCT01073618|P1|Participant Flow|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
238705|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
238706|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
238707|NCT01073618|E1|Reported Event|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
238708|NCT01073605|B4|Baseline|Total|Total of all reporting groups
238709|NCT01073605|B3|Baseline|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238710|NCT01073605|B2|Baseline|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238711|NCT01073605|B1|Baseline|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238712|NCT01073605|P3|Participant Flow|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238713|NCT01073605|P2|Participant Flow|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238714|NCT01073605|P1|Participant Flow|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238715|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238716|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
239147|NCT01072201|B1|Baseline|Total Toothpaste|Triclosan/copolymer/Fluoride
238717|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238718|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238719|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238720|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238721|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238722|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238723|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238724|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238725|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238726|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238727|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238728|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238729|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238730|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238731|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238732|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238733|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238734|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238735|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238736|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238737|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238738|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238739|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238740|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238741|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238742|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238743|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238744|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238745|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238746|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238747|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238748|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238749|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238750|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238751|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238752|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238753|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238754|NCT01073605|E3|Reported Event|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238755|NCT01073605|E2|Reported Event|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238756|NCT01073605|E1|Reported Event|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
238757|NCT01073566|B3|Baseline|Total|Total of all reporting groups
238758|NCT01073566|B2|Baseline|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
238759|NCT01073566|B1|Baseline|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
238760|NCT01073566|P2|Participant Flow|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
238761|NCT01073566|P1|Participant Flow|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
238762|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
238763|NCT01073566|O1|Outcome|Finesse|Bolus Patch
238764|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
238765|NCT01073566|O1|Outcome|Finesse|Bolus Patch
238766|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
238767|NCT01073566|O1|Outcome|Finesse|Bolus Patch
238768|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
238769|NCT01073566|O1|Outcome|Finesse|Bolus Patch
238770|NCT01073566|E2|Reported Event|Usual Injection Device|Pen/Syringe
238771|NCT01073566|E1|Reported Event|Finesse|Bolus Patch
238772|NCT01073462|B1|Baseline|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238773|NCT01073462|P1|Participant Flow|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238774|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238775|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238776|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238777|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
249281|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
238778|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238779|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238780|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238781|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
238782|NCT01073462|E1|Reported Event|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
238783|NCT01073449|B1|Baseline|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238784|NCT01073449|P1|Participant Flow|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238785|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238786|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238787|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238788|NCT01073449|E1|Reported Event|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
238789|NCT01073293|B3|Baseline|Total|Total of all reporting groups
238790|NCT01073293|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238791|NCT01073293|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238792|NCT01073293|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238793|NCT01073293|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238794|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238795|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238796|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238797|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238798|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238799|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238800|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238801|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238802|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238803|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238804|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238805|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238806|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
249282|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
238807|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238808|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238809|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238810|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238811|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
238812|NCT01073293|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
238813|NCT01073293|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1
238814|NCT01073267|B1|Baseline|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
238815|NCT01073267|P1|Participant Flow|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
238816|NCT01073267|O1|Outcome|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
238817|NCT01073267|E1|Reported Event|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
238818|NCT01073163|B1|Baseline|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238819|NCT01073163|P1|Participant Flow|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238820|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238821|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238822|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238823|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238824|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238825|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238826|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238827|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238828|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238829|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238830|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
238831|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
238832|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238833|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238834|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
239148|NCT01072201|P2|Participant Flow|Ultrabrite Toothpaste|sodium fluoride control(placebo)
238835|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238836|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238837|NCT01073163|E1|Reported Event|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
238838|NCT01072929|B4|Baseline|Total|Total of all reporting groups
238839|NCT01072929|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238840|NCT01072929|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238841|NCT01072929|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238842|NCT01072929|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238843|NCT01072929|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238844|NCT01072929|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238845|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238846|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238847|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238848|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238849|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238850|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238851|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238852|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238853|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238854|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238855|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238856|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238857|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238858|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238859|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238860|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238861|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238862|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238863|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239149|NCT01072201|P1|Participant Flow|Total Toothpaste|Triclosan/copolymer/Fluoride
238864|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238865|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238866|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238867|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238868|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238869|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238870|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238871|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238872|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238873|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238874|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238875|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238876|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238877|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238878|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238879|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238880|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238881|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238882|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238883|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238884|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238885|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238886|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238887|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238888|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238889|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238890|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238891|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238892|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239150|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
238893|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238894|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238895|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238896|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238897|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238898|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238899|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238900|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238901|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238902|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238903|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238904|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238905|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238906|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238907|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238908|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238909|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238910|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238911|NCT01072929|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
238912|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238913|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238914|NCT01072929|E3|Reported Event|PLACEBO|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238915|NCT01072929|E2|Reported Event|ARMODAFINIL 200 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238916|NCT01072929|E1|Reported Event|ARMODAFINIL 150 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238917|NCT01072877|B6|Baseline|Total|Total of all reporting groups
238918|NCT01072877|B5|Baseline|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam2.0%
238919|NCT01072877|B4|Baseline|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam 1.0%
238920|NCT01072877|B3|Baseline|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam 0.5%
238921|NCT01072877|B2|Baseline|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam 0.125%
238922|NCT01072877|B1|Baseline|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
238923|NCT01072877|P5|Participant Flow|Polidocanol Endovenous Microfoam 2.0%|"Polidocanol endovenous microfoam 2.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
238924|NCT01072877|P4|Participant Flow|Polidocanol Endovenous Microfoam 1.0%|"Polidocanol endovenous microfoam 1.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
238925|NCT01072877|P3|Participant Flow|Polidocanol Endovenous Microfoam 0.5%|"Polidocanol endovenous microfoam 0.5%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
239151|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
238926|NCT01072877|P2|Participant Flow|Polidocanol Endovenous Microfoam 0.125%|"Polidocanol endovenous microfoam 0.125%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
238927|NCT01072877|P1|Participant Flow|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
238928|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
238929|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
238930|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
238931|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
238932|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
238933|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
238934|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
238935|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
238936|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
238937|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
238938|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
238939|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at 1.0% concentration
238940|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
238941|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
238942|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
238943|NCT01072877|E5|Reported Event|Polidocanol Endovenous Microfoam 2.0%|polidocanol injectable foam at a 2.0% concentration
238944|NCT01072877|E4|Reported Event|Polidocanol Injectable Foam 1.0%|polidocanol injectable foam at a 1.0% concentration
238945|NCT01072877|E3|Reported Event|Polidcanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
238946|NCT01072877|E2|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam at a 0.125% concentration
238947|NCT01072877|E1|Reported Event|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
238948|NCT01072773|B1|Baseline|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238949|NCT01072773|P1|Participant Flow|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238950|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238951|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238952|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238953|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238954|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238955|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238956|NCT01072773|E1|Reported Event|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
238957|NCT01072669|B3|Baseline|Total|Total of all reporting groups
238958|NCT01072669|B2|Baseline|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
238959|NCT01072669|B1|Baseline|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
238960|NCT01072669|P2|Participant Flow|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
238961|NCT01072669|P1|Participant Flow|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
238962|NCT01072669|O2|Outcome|Sugar Pill|Placebo, same appearing as Ambrisentan
238963|NCT01072669|O1|Outcome|Ambrisentan|Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months
238964|NCT01072669|E2|Reported Event|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
238965|NCT01072669|E1|Reported Event|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
238966|NCT01072656|B3|Baseline|Total|Total of all reporting groups
238967|NCT01072656|B2|Baseline|Sham First|sham stimulation - IPG ON, at 0 Volt
238968|NCT01072656|B1|Baseline|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
238969|NCT01072656|P2|Participant Flow|Sham First|sham stimulation - IPG ON, at 0 Volt
238970|NCT01072656|P1|Participant Flow|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
238971|NCT01072656|O2|Outcome|Sham Stimulation|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
239152|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
238972|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
238973|NCT01072656|E3|Reported Event|Phase I-IV|Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
238974|NCT01072656|E2|Reported Event|Sham Stimulation (Phase V)|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
238975|NCT01072656|E1|Reported Event|Active Stimulation (Phase V)|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
238976|NCT01072643|B1|Baseline|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
238977|NCT01072643|P1|Participant Flow|Dexmedetomidine 1 mcg/kg Bolus|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
238978|NCT01072643|O4|Outcome|Subject 4|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
238979|NCT01072643|O3|Outcome|Subject 3|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
238980|NCT01072643|O2|Outcome|Subject 2|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
238981|NCT01072643|O1|Outcome|Subject 1|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
238982|NCT01072643|E1|Reported Event|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
238983|NCT01072630|B4|Baseline|Total|Total of all reporting groups
238984|NCT01072630|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238985|NCT01072630|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238986|NCT01072630|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238987|NCT01072630|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238988|NCT01072630|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238989|NCT01072630|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238990|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238991|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238992|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238993|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238994|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238995|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238996|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
238997|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
238998|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
238999|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239000|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239001|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239002|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239003|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239004|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239005|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239006|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239007|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239008|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239009|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239010|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239011|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239012|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239013|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239014|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239015|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239016|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239017|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239018|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239019|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239153|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
239020|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239021|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239022|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239023|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239024|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239025|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239026|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239027|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239028|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239029|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239030|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239031|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239032|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239033|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239034|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239035|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239036|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239037|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239038|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239039|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239040|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239041|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239042|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239043|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239044|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239045|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239046|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239047|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239154|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
239155|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
239048|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239049|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239050|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239051|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239052|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239053|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239054|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239055|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239056|NCT01072630|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
239057|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239058|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239059|NCT01072630|E3|Reported Event|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
239060|NCT01072630|E2|Reported Event|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
239061|NCT01072630|E1|Reported Event|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
239062|NCT01072539|B1|Baseline|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239063|NCT01072539|P1|Participant Flow|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239064|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239065|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239066|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239067|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239068|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239069|NCT01072539|E1|Reported Event|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
239070|NCT01072526|B1|Baseline|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239071|NCT01072526|P2|Participant Flow|Control|Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239072|NCT01072526|P1|Participant Flow|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239073|NCT01072526|O2|Outcome|Control|"Subjects will receive placebo in combination with cyclosporin (Restasis) solution.~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
239074|NCT01072526|O1|Outcome|Intervention|"Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin (Restasis) solution.~Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
239075|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239076|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239077|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239078|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239079|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239080|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239081|NCT01072526|O2|Outcome|Control|cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239082|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239083|NCT01072526|E1|Reported Event|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
239084|NCT01072500|B3|Baseline|Total|Total of all reporting groups
239085|NCT01072500|B2|Baseline|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
239086|NCT01072500|B1|Baseline|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
239087|NCT01072500|P2|Participant Flow|Successful Aging (Health Education)|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
239088|NCT01072500|P1|Participant Flow|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
239089|NCT01072500|O2|Outcome|Successful Aging|"The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.~Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises."
239090|NCT01072500|O1|Outcome|Physical Activity|"The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.~Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling."
239091|NCT01072500|O2|Outcome|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
239092|NCT01072500|O1|Outcome|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
239093|NCT01072500|E2|Reported Event|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
239094|NCT01072500|E1|Reported Event|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
239095|NCT01072448|B3|Baseline|Total|Total of all reporting groups
239096|NCT01072448|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239097|NCT01072448|B1|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239098|NCT01072448|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239156|NCT01072201|E2|Reported Event|Ultrabrite Toothpaste|sodium fluoride control (placebo)
239099|NCT01072448|P1|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239100|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239101|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239102|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239103|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239104|NCT01072448|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239105|NCT01072448|E1|Reported Event|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
239106|NCT01072409|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint.
239107|NCT01072409|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint.
239108|NCT01072409|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint.
239109|NCT01072409|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint.
239110|NCT01072396|B3|Baseline|Total|Total of all reporting groups
239111|NCT01072396|B2|Baseline|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
239112|NCT01072396|B1|Baseline|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
239113|NCT01072396|P2|Participant Flow|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
239114|NCT01072396|P1|Participant Flow|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
239115|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
239116|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
239117|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
239118|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
239119|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
239120|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
239121|NCT01072396|E2|Reported Event|Tiotropium|Patients who received tiotropium in period one or period two
239122|NCT01072396|E1|Reported Event|Placebo|Patients who received placebo in period one or period two
239123|NCT01072331|B4|Baseline|Total|Total of all reporting groups
239124|NCT01072331|B3|Baseline|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239125|NCT01072331|B2|Baseline|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239126|NCT01072331|B1|Baseline|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239127|NCT01072331|P3|Participant Flow|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239128|NCT01072331|P2|Participant Flow|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239129|NCT01072331|P1|Participant Flow|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239130|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239131|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239132|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239133|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239134|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239135|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239136|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239137|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239138|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239139|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239140|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239141|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239142|NCT01072331|E3|Reported Event|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
239143|NCT01072331|E2|Reported Event|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
239144|NCT01072331|E1|Reported Event|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
239160|NCT01072188|B1|Baseline|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
239161|NCT01072188|P2|Participant Flow|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
239162|NCT01072188|P1|Participant Flow|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
239163|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
239164|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
239165|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
239166|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
239167|NCT01072188|E2|Reported Event|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
239168|NCT01072188|E1|Reported Event|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
239169|NCT01072175|B13|Baseline|Total|Total of all reporting groups
239170|NCT01072175|B12|Baseline|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239171|NCT01072175|B11|Baseline|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239172|NCT01072175|B10|Baseline|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239173|NCT01072175|B9|Baseline|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239174|NCT01072175|B8|Baseline|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239175|NCT01072175|B7|Baseline|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239176|NCT01072175|B6|Baseline|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239177|NCT01072175|B5|Baseline|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239178|NCT01072175|B4|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239179|NCT01072175|B3|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239180|NCT01072175|B2|Baseline|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239181|NCT01072175|B1|Baseline|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239182|NCT01072175|P13|Participant Flow|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239183|NCT01072175|P12|Participant Flow|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239184|NCT01072175|P11|Participant Flow|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239185|NCT01072175|P10|Participant Flow|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239186|NCT01072175|P9|Participant Flow|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
239187|NCT01072175|P8|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239188|NCT01072175|P7|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239189|NCT01072175|P6|Participant Flow|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239190|NCT01072175|P5|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239191|NCT01072175|P4|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239192|NCT01072175|P3|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239193|NCT01072175|P2|Participant Flow|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239194|NCT01072175|P1|Participant Flow|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239195|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239196|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239197|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239198|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239199|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239200|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239201|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239202|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239203|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239204|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239205|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239206|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239207|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239208|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239209|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239210|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239211|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239212|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239213|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239214|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239215|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239216|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239217|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239218|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239219|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239220|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239221|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239222|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239223|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239224|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239225|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239226|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239227|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239228|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239229|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239230|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239231|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
239232|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239233|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
239234|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239235|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239236|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239237|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239238|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239239|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239240|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239241|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239242|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239243|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239244|NCT01072175|O1|Outcome|Part B: Dabrafenib + Trametinib|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib (75 mg or 150 mg) gelatin capsules BID and trametinib (1 mg, 1.5 mg, or 2 mg) tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239245|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239294|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239295|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239246|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239247|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239248|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239249|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239250|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239251|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239252|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239253|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239254|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239255|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239256|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239257|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239258|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239259|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239296|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239597|NCT01071083|B3|Baseline|Interferon β-1a|30 ug intramuscular once per week
239260|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239261|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239262|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239263|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239264|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239265|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239266|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239267|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239268|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239269|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239270|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239271|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239272|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239273|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239274|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239275|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239276|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239277|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239278|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239279|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239280|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239281|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239282|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239283|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239284|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239285|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239286|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239287|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239288|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239289|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239290|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239291|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239292|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239293|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239297|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239298|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239299|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239300|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239301|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239302|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239303|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239304|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239305|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239306|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239307|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239308|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239309|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239310|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239311|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239312|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239313|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239314|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239315|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239316|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239317|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239318|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239319|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239320|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239321|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239322|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239323|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239324|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239325|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239326|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
239327|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239328|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239329|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239330|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239331|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239332|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239333|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239334|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239335|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239336|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
239337|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239338|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239339|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239340|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239341|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239342|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239343|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239344|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239345|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239346|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239347|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239348|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239349|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239350|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239351|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239352|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
249283|NCT01037244|O4|Outcome|Placebo|Placebo tablets
239353|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239354|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239355|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239356|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239357|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239358|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239359|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239360|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
239361|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239362|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
239363|NCT01072175|E13|Reported Event|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239364|NCT01072175|E12|Reported Event|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
239365|NCT01072175|E11|Reported Event|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239366|NCT01072175|E10|Reported Event|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
239367|NCT01072175|E9|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
239368|NCT01072175|E8|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
239369|NCT01072175|E7|Reported Event|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
239370|NCT01072175|E6|Reported Event|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
239371|NCT01072175|E5|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
239372|NCT01072175|E4|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239373|NCT01072175|E3|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
239435|NCT01072136|E1|Reported Event|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239374|NCT01072175|E2|Reported Event|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
239375|NCT01072175|E1|Reported Event|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
239376|NCT01072149|B1|Baseline|Entire Study Population|All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
239377|NCT01072149|P18|Participant Flow|Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239378|NCT01072149|P17|Participant Flow|Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239379|NCT01072149|P16|Participant Flow|Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239380|NCT01072149|P15|Participant Flow|Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239381|NCT01072149|P14|Participant Flow|Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239382|NCT01072149|P13|Participant Flow|Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239383|NCT01072149|P12|Participant Flow|Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239384|NCT01072149|P11|Participant Flow|Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239385|NCT01072149|P10|Participant Flow|Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239386|NCT01072149|P9|Participant Flow|Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239387|NCT01072149|P8|Participant Flow|Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239388|NCT01072149|P7|Participant Flow|Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239389|NCT01072149|P6|Participant Flow|Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239390|NCT01072149|P5|Participant Flow|Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239391|NCT01072149|P4|Participant Flow|Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239392|NCT01072149|P3|Participant Flow|Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239393|NCT01072149|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239436|NCT01072032|B3|Baseline|Total|Total of all reporting groups
239598|NCT01071083|B2|Baseline|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
239394|NCT01072149|P1|Participant Flow|Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg|Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
239395|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239396|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239397|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239398|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
239399|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239400|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239401|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239402|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
239403|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239404|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239405|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239406|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
239407|NCT01072149|E4|Reported Event|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239408|NCT01072149|E3|Reported Event|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239409|NCT01072149|E2|Reported Event|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
239410|NCT01072149|E1|Reported Event|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
239411|NCT01072136|B3|Baseline|Total|Total of all reporting groups
239412|NCT01072136|B2|Baseline|Placebo|Placebo
239413|NCT01072136|B1|Baseline|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239414|NCT01072136|P2|Participant Flow|Placebo|Placebo
239415|NCT01072136|P1|Participant Flow|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239416|NCT01072136|O2|Outcome|Placebo|Placebo
239417|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239418|NCT01072136|O2|Outcome|Placebo|Placebo
239419|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239420|NCT01072136|O2|Outcome|Placebo|Placebo
239421|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239422|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
239423|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
239424|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
239425|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
239426|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
239427|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
239428|NCT01072136|O2|Outcome|Placebo|Placebo
239429|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239430|NCT01072136|O2|Outcome|Placebo|Placebo
239431|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239432|NCT01072136|O2|Outcome|Placebo|Placebo
239433|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
239434|NCT01072136|E2|Reported Event|Placebo|Placebo
249284|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
239437|NCT01072032|B2|Baseline|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239438|NCT01072032|B1|Baseline|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239439|NCT01072032|P2|Participant Flow|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239440|NCT01072032|P1|Participant Flow|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239441|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
239442|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
239443|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
239444|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
239445|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
239446|NCT01072032|O1|Outcome|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team."
239447|NCT01072032|E2|Reported Event|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239448|NCT01072032|E1|Reported Event|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
239449|NCT01071915|B1|Baseline|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239450|NCT01071915|P1|Participant Flow|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239451|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239452|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239453|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239454|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239455|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239456|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239457|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239458|NCT01071915|E1|Reported Event|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
239460|NCT01071798|P1|Participant Flow|Main Analysis Set|Participants who received at least one cycle of rituximab
239461|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
239462|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
239463|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
239464|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
239465|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
239466|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
239467|NCT01071798|O3|Outcome|Total|During the Trial - All Participants
239468|NCT01071798|O2|Outcome|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
239469|NCT01071798|O1|Outcome|Cycle 1|During Cycle 1 - Main Analysis Set
239470|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
239471|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
239472|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
239473|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
239474|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
239475|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
239476|NCT01071798|E3|Reported Event|Total|During the entire trial
239477|NCT01071798|E2|Reported Event|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
239478|NCT01071798|E1|Reported Event|Cycle 1|During Cycle 1 - Main Analysis Set
239479|NCT01071538|B1|Baseline|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239480|NCT01071538|P1|Participant Flow|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239481|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239482|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239483|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239484|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239485|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239486|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239487|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239488|NCT01071538|E1|Reported Event|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
239489|NCT01071395|B3|Baseline|Total|Total of all reporting groups
239490|NCT01071395|B2|Baseline|Placebo|Placebo: Sugar pill given 3 times daily
239491|NCT01071395|B1|Baseline|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
239492|NCT01071395|P2|Participant Flow|Placebo|Placebo: Sugar pill given 3 times daily
239493|NCT01071395|P1|Participant Flow|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
239494|NCT01071395|O2|Outcome|Placebo|Placebo: Sugar pill given daily in three divided doses
239495|NCT01071395|O1|Outcome|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
239496|NCT01071395|E2|Reported Event|Placebo|Placebo: Sugar pill given 3 times daily
239497|NCT01071395|E1|Reported Event|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
239599|NCT01071083|B1|Baseline|Natalizumab|300 mg intravenous every 4 weeks
239600|NCT01071083|P5|Participant Flow|Methylprednisolone|1000 mg intravenous every 4 weeks
249285|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
239498|NCT01071278|B1|Baseline|Intent-to-Treat Population|Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
239499|NCT01071278|P1|Participant Flow|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
239500|NCT01071278|O1|Outcome|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
239501|NCT01071278|O2|Outcome|Patients Treated Outside a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
239502|NCT01071278|O1|Outcome|Patients Treated Within a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
239503|NCT01071278|E1|Reported Event|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
239504|NCT01071252|B6|Baseline|Total|Total of all reporting groups
239505|NCT01071252|B5|Baseline|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239506|NCT01071252|B4|Baseline|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239507|NCT01071252|B3|Baseline|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239508|NCT01071252|B2|Baseline|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239509|NCT01071252|B1|Baseline|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239510|NCT01071252|P5|Participant Flow|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239511|NCT01071252|P4|Participant Flow|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239512|NCT01071252|P3|Participant Flow|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239513|NCT01071252|P2|Participant Flow|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239514|NCT01071252|P1|Participant Flow|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239515|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239516|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239517|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239518|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239519|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239520|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239521|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239522|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239523|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239524|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239525|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239526|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239527|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239528|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239529|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239530|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239531|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239532|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239533|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239534|NCT01071252|E5|Reported Event|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239535|NCT01071252|E4|Reported Event|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239536|NCT01071252|E3|Reported Event|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239537|NCT01071252|E2|Reported Event|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
239538|NCT01071252|E1|Reported Event|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
239539|NCT01071200|B3|Baseline|Total|Total of all reporting groups
239540|NCT01071200|B2|Baseline|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
239541|NCT01071200|B1|Baseline|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239542|NCT01071200|P2|Participant Flow|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
239601|NCT01071083|P4|Participant Flow|Glatiramer Acetate|20 mg subcutaneous once daily
239602|NCT01071083|P3|Participant Flow|Interferon β-1a|30 ug intramuscular once per week
239543|NCT01071200|P1|Participant Flow|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239544|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239545|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239546|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239547|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239548|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239549|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239550|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239551|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239552|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239553|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239554|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239555|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239556|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239557|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239558|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239559|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239560|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239561|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239562|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239563|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239564|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239565|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239566|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239567|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239568|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239569|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239570|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239571|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239572|NCT01071200|E2|Reported Event|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
239573|NCT01071200|E1|Reported Event|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
239574|NCT01071096|B1|Baseline|Enrolled Participants|Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
239575|NCT01071096|P2|Participant Flow|Group B|Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
239576|NCT01071096|P1|Participant Flow|Group A|Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
239577|NCT01071096|O6|Outcome|Month 1 vs. Month 3 Non-Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
239578|NCT01071096|O5|Outcome|Month 1 vs. Month 3 Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
239579|NCT01071096|O4|Outcome|Month 3 vs. Saline Non-Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
239580|NCT01071096|O3|Outcome|Month 3 vs. Saline Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
239581|NCT01071096|O2|Outcome|Month 1 vs. Saline Non-Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
239582|NCT01071096|O1|Outcome|Month 1 vs. Saline Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
239583|NCT01071096|O3|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
239584|NCT01071096|O2|Outcome|OnabotulinumtoxinA Non-Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
239585|NCT01071096|O1|Outcome|OnabotulinumtoxinA Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
239586|NCT01071096|O2|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
239587|NCT01071096|O1|Outcome|OnabotulinumtoxinA|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
239588|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
239589|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
239590|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
239591|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
239592|NCT01071096|E2|Reported Event|OnabotulinumtoxinA|Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
239593|NCT01071096|E1|Reported Event|Saline|Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
239594|NCT01071083|B6|Baseline|Total|Total of all reporting groups
239603|NCT01071083|P2|Participant Flow|Natalizumab|300 mg intravenous every 4 weeks
239604|NCT01071083|P1|Participant Flow|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
239605|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
239606|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
239607|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
239608|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
239609|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
239610|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
239611|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
239612|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
239613|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
239614|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
239615|NCT01071083|E5|Reported Event|Methylprednisolone|1000 mg intravenous every 4 weeks
239616|NCT01071083|E4|Reported Event|Glatiramer Acetate|20 mg subcutaneous once daily
239617|NCT01071083|E3|Reported Event|Interferon β-1a|30 ug intramuscular once per week
239618|NCT01071083|E2|Reported Event|Natalizumab|300 mg intravenous every 4 weeks
239619|NCT01071083|E1|Reported Event|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
239620|NCT01071070|B3|Baseline|Total|Total of all reporting groups
239621|NCT01071070|B2|Baseline|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239622|NCT01071070|B1|Baseline|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239623|NCT01071070|P2|Participant Flow|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239624|NCT01071070|P1|Participant Flow|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239625|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239626|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239627|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239628|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239629|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239630|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239631|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239632|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239633|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239634|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239635|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239636|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239637|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239638|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239639|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239640|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239641|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239642|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239643|NCT01071070|E2|Reported Event|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
239644|NCT01071070|E1|Reported Event|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
239645|NCT01071044|B3|Baseline|Total|Total of all reporting groups
239646|NCT01071044|B2|Baseline|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
239693|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239694|NCT01070979|E3|Reported Event|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239695|NCT01070979|E2|Reported Event|Estradiol|1 tablet daily containing 1 mg estradiol
239647|NCT01071044|B1|Baseline|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
239648|NCT01071044|P2|Participant Flow|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
239649|NCT01071044|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
239650|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239651|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
239652|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239653|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
239654|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239655|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
239656|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50, or 70mg"
239657|NCT01071044|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate 30, 50, 70 mg
239658|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239659|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
239660|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239661|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
239662|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
239663|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
239664|NCT01071044|E2|Reported Event|Control Group|"Placebo 30, 50 or 70 mg"
239665|NCT01071044|E1|Reported Event|Treatment Group|Lisdexamfetamine Dimesylate 30, 50, or 70 mg
239666|NCT01070979|B4|Baseline|Total|Total of all reporting groups
239667|NCT01070979|B3|Baseline|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239668|NCT01070979|B2|Baseline|Estradiol|1 tablet daily containing 1 mg estradiol
239669|NCT01070979|B1|Baseline|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239670|NCT01070979|P3|Participant Flow|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239671|NCT01070979|P2|Participant Flow|Estradiol|1 tablet daily containing 1 mg estradiol
239672|NCT01070979|P1|Participant Flow|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239673|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239674|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239675|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239676|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239677|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239678|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239679|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239680|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239681|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239682|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239683|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239684|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239685|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239686|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239687|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239688|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239689|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239690|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239691|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
239692|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
239696|NCT01070979|E1|Reported Event|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
239697|NCT01070966|B1|Baseline|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
239698|NCT01070966|P1|Participant Flow|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
239699|NCT01070966|O3|Outcome|Participants Percent Change|
239700|NCT01070966|O2|Outcome|Participants Treatment Lipid Parameters|Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
239701|NCT01070966|O1|Outcome|Participants Baseline Lipid Parameters|Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
239702|NCT01070966|O1|Outcome|Participants Treated With VYTORIN|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
239703|NCT01070966|E5|Reported Event|VYTORIN YEAR 6|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
239704|NCT01070966|E4|Reported Event|VYTORIN YEAR 5|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
239705|NCT01070966|E3|Reported Event|VYTORIN YEAR 4|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
239706|NCT01070966|E2|Reported Event|VYTORIN YEAR 2|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
239707|NCT01070966|E1|Reported Event|VYTORIN YEAR 1|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
239708|NCT01070953|B1|Baseline|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
239709|NCT01070953|P1|Participant Flow|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
239710|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
239711|NCT01070953|O1|Outcome|All Participants|
239712|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
239713|NCT01070953|E6|Reported Event|EZETROL Year 6|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
239714|NCT01070953|E5|Reported Event|EZETROL Year 5|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
239715|NCT01070953|E4|Reported Event|EZETROL Year 4|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
239716|NCT01070953|E3|Reported Event|EZETROL Year 3|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
239717|NCT01070953|E2|Reported Event|EZETROL Year 2|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
239718|NCT01070953|E1|Reported Event|EZETROL Year 1|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
239719|NCT01070888|B3|Baseline|Total|Total of all reporting groups
239720|NCT01070888|B2|Baseline|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,"
239721|NCT01070888|B1|Baseline|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
239722|NCT01070888|P2|Participant Flow|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
239723|NCT01070888|P1|Participant Flow|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
239724|NCT01070888|O2|Outcome|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
239725|NCT01070888|O1|Outcome|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
239726|NCT01070888|E2|Reported Event|Budesonide|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks"
239727|NCT01070888|E1|Reported Event|Budesonide/Formoterol|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
239728|NCT01070784|B3|Baseline|Total|Total of all reporting groups
239729|NCT01070784|B2|Baseline|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239730|NCT01070784|B1|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239731|NCT01070784|P2|Participant Flow|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239732|NCT01070784|P1|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239733|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239734|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239735|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239736|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239737|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239738|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239739|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239740|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239741|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239742|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239743|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239744|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239745|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239746|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239747|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239748|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239749|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239750|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239751|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239752|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239753|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239754|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239755|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239756|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239757|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239758|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239759|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239760|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239761|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239762|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239763|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239764|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239765|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239766|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239767|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239768|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239769|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239770|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239771|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239772|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239773|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239774|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239775|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239776|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239777|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239778|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239779|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239780|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239781|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239782|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239783|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239784|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239785|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239786|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239787|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239788|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239789|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239790|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239791|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239792|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239793|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239794|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239795|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239796|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239797|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239798|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239799|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239800|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239801|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239802|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239803|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239804|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239805|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239806|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239807|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239808|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239809|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239810|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239811|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239812|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239813|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239814|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239815|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239816|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239817|NCT01070784|E2|Reported Event|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
239818|NCT01070784|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
239819|NCT01070771|B1|Baseline|Radi Pressure Wire|
239820|NCT01070771|P1|Participant Flow|Radi Pressure Wire|Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
239821|NCT01070771|O1|Outcome|RADI Pressure Wire|
239822|NCT01070771|O1|Outcome|Radi Pressure Wire|
239823|NCT01070771|E1|Reported Event|RADI Pressure Wire|
239824|NCT01070693|B3|Baseline|Total|Total of all reporting groups
239825|NCT01070693|B2|Baseline|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
239826|NCT01070693|B1|Baseline|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
239827|NCT01070693|P2|Participant Flow|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
239828|NCT01070693|P1|Participant Flow|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
239829|NCT01070693|O2|Outcome|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
239830|NCT01070693|O1|Outcome|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
239831|NCT01070693|E2|Reported Event|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
240314|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
239832|NCT01070693|E1|Reported Event|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
239833|NCT01070550|B7|Baseline|Total|Total of all reporting groups
239834|NCT01070550|B6|Baseline|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239835|NCT01070550|B5|Baseline|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239836|NCT01070550|B4|Baseline|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239837|NCT01070550|B3|Baseline|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239838|NCT01070550|B2|Baseline|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239839|NCT01070550|B1|Baseline|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239840|NCT01070550|P6|Participant Flow|Genotype Unknown|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239841|NCT01070550|P5|Participant Flow|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239842|NCT01070550|P4|Participant Flow|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
239843|NCT01070550|P3|Participant Flow|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
239844|NCT01070550|P2|Participant Flow|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
239845|NCT01070550|P1|Participant Flow|Genotype 1|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
239846|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239847|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239848|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239849|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239850|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239851|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239852|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239853|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239854|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239855|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239856|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239857|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239858|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239859|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
240614|NCT01068769|E1|Reported Event|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
239860|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239861|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239862|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239863|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239864|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239865|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239866|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239867|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239868|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239869|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239870|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239871|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239872|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239873|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239874|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239875|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239876|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239877|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239878|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239879|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239880|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239881|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239882|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239883|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239884|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239885|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239886|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239887|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
240615|NCT01068743|B1|Baseline|All Enrolled and Treated Participants|
239888|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239889|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239890|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239891|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239892|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239893|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239894|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239895|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239896|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239897|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239898|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239899|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239900|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239901|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239902|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239903|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239904|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239905|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239906|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239907|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239908|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239909|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239910|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239911|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239912|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239913|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239914|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239915|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
240656|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
239916|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239917|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239918|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239919|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239920|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239921|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239922|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239923|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239924|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239925|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239926|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239927|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239928|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239929|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239930|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239931|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239932|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239933|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239934|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239935|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239936|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239937|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239938|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239939|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239940|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239941|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239942|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239943|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
240657|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
239944|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239945|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239946|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239947|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239948|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239949|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239950|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239951|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239952|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239953|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239954|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239955|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239956|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239957|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239958|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239959|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239960|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239961|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239962|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239963|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239964|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239965|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239966|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239967|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239968|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239969|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239970|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239971|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
240659|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
239972|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239973|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239974|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239975|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239976|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239977|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received Peginterferon (PEG-IFN) alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239978|NCT01070550|E6|Reported Event|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239979|NCT01070550|E5|Reported Event|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239980|NCT01070550|E4|Reported Event|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239981|NCT01070550|E3|Reported Event|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239982|NCT01070550|E2|Reported Event|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239983|NCT01070550|E1|Reported Event|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
239984|NCT01070394|B1|Baseline|LDX Treatment|Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
239985|NCT01070394|P1|Participant Flow|Overall Study: Lisdexamfetamine Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239986|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239987|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239988|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
240010|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240011|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
242718|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
239989|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239990|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239991|NCT01070394|O1|Outcome|Treatment Arm|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239992|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239993|NCT01070394|O1|Outcome|Overall Study|"Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.~LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks."
239994|NCT01070394|E1|Reported Event|LDX Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
239995|NCT01070381|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
239996|NCT01070381|P2|Participant Flow|Ocufilcon D / Nelfilcon A|Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
239997|NCT01070381|P1|Participant Flow|Nelfilcon A / Ocufilcon D|Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
239998|NCT01070381|O2|Outcome|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
239999|NCT01070381|O1|Outcome|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
240000|NCT01070381|E2|Reported Event|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
240001|NCT01070381|E1|Reported Event|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
240002|NCT01070329|B3|Baseline|Total|Total of all reporting groups
240003|NCT01070329|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
240004|NCT01070329|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240005|NCT01070329|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
240006|NCT01070329|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240007|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240008|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240009|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240012|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240013|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240014|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240015|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240016|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240017|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240018|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240019|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240020|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240021|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240022|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240023|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240024|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240025|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240026|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240027|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240028|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240029|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240030|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240031|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240032|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240033|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
240034|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240035|NCT01070329|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
240036|NCT01070329|E1|Reported Event|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
240037|NCT01070316|B1|Baseline|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
240038|NCT01070316|P1|Participant Flow|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
240056|NCT01070303|O2|Outcome|Change From Baseline-Week 152|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
240057|NCT01070303|O1|Outcome|Change From Baseline-Week 104|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
240244|NCT01069562|B1|Baseline|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240039|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
240040|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
240041|NCT01070316|E1|Reported Event|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
240042|NCT01070303|B3|Baseline|Total|Total of all reporting groups
240043|NCT01070303|B2|Baseline|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240044|NCT01070303|B1|Baseline|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240045|NCT01070303|P1|Participant Flow|All Participants in Open-Label Extension of Study M02-433|Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
240046|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240047|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240048|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240049|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240050|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240051|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240052|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240053|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240054|NCT01070303|O4|Outcome|Change From Baseline-Week 248|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
240055|NCT01070303|O3|Outcome|Change From Baseline-Week 200|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
240660|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240058|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240059|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240060|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240061|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240062|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240063|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240064|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240065|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240066|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240067|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240068|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240069|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240070|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240071|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240072|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240073|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240074|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240075|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240076|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240077|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240078|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240079|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240080|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240081|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240117|NCT01070043|B2|Baseline|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
249286|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
240082|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240083|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240084|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240085|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240086|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240087|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240088|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240089|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240090|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240091|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240092|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240093|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240094|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240095|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240096|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240097|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240098|NCT01070303|E2|Reported Event|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
240099|NCT01070303|E1|Reported Event|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
240100|NCT01070173|B4|Baseline|Total|Total of all reporting groups
240101|NCT01070173|B3|Baseline|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms
240102|NCT01070173|B2|Baseline|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive)
240103|NCT01070173|B1|Baseline|Short Stature|Poor linear growth
240104|NCT01070173|P3|Participant Flow|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
240105|NCT01070173|P2|Participant Flow|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
240106|NCT01070173|P1|Participant Flow|Short Stature|Poor linear growth Group
240107|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
240108|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
240109|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
240110|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
240111|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
240112|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
240113|NCT01070173|E3|Reported Event|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
240114|NCT01070173|E2|Reported Event|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
240115|NCT01070173|E1|Reported Event|Short Stature|Poor linear growth Group
240116|NCT01070043|B3|Baseline|Total|Total of all reporting groups
240661|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240118|NCT01070043|B1|Baseline|Amlodipine 5mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240119|NCT01070043|P3|Participant Flow|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240120|NCT01070043|P2|Participant Flow|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240121|NCT01070043|P1|Participant Flow|Run-In Valsartan 80 mg|During run-in period, oral valsartan 80 mg once daily for 4 weeks.
240122|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240123|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240124|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240125|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240126|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240127|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240128|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240129|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240130|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240131|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240132|NCT01070043|E2|Reported Event|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
240133|NCT01070043|E1|Reported Event|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
240134|NCT01069939|B3|Baseline|Total|Total of all reporting groups
240135|NCT01069939|B2|Baseline|Placebo|Placebo once daily oral
240136|NCT01069939|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240137|NCT01069939|P2|Participant Flow|Placebo|Placebo once daily oral
240138|NCT01069939|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240139|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240140|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240141|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240142|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240143|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240144|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240145|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240146|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240147|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240148|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240149|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240150|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240151|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240152|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240153|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240154|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240155|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240156|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240157|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
240158|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240159|NCT01069939|E2|Reported Event|Placebo|Placebo once daily oral
240160|NCT01069939|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
240161|NCT01069900|B3|Baseline|Total|Total of all reporting groups
240162|NCT01069900|B2|Baseline|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240163|NCT01069900|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240164|NCT01069900|P2|Participant Flow|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240243|NCT01069562|B2|Baseline|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240921|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240165|NCT01069900|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240166|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240167|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240168|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240169|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240170|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240171|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240172|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240173|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240174|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240175|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240176|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240177|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240178|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240179|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240180|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240181|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240182|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240183|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240184|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240185|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240186|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240187|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240188|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240189|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240190|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240191|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240192|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240193|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240194|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240195|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240196|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240197|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240198|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240199|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240200|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240201|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240202|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240203|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240204|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240205|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
240206|NCT01069900|E2|Reported Event|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
240207|NCT01069900|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
240208|NCT01069861|B1|Baseline|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240209|NCT01069861|P1|Participant Flow|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant.
240210|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240211|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240212|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240213|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240214|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240215|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240216|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240217|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240218|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240219|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240220|NCT01069861|E1|Reported Event|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
240221|NCT01069627|B1|Baseline|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240222|NCT01069627|P1|Participant Flow|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240223|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240967|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240968|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240224|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240225|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240226|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240227|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240228|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240229|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240230|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240231|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240232|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240245|NCT01069562|P2|Participant Flow|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240233|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240234|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240235|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240236|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240237|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240238|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240239|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240240|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240241|NCT01069627|E1|Reported Event|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
240242|NCT01069562|B3|Baseline|Total|Total of all reporting groups
240969|NCT01067976|O1|Outcome|CMRM vs UMRM|
240246|NCT01069562|P1|Participant Flow|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240247|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240248|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240249|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240250|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240251|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240252|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240253|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240254|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240255|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240256|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240257|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240258|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240259|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240260|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240261|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240262|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240263|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240264|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240265|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240266|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240267|NCT01069562|E2|Reported Event|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
240268|NCT01069562|E1|Reported Event|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
240269|NCT01069523|B3|Baseline|Total|Total of all reporting groups
240270|NCT01069523|B2|Baseline|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240271|NCT01069523|B1|Baseline|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240272|NCT01069523|P2|Participant Flow|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240273|NCT01069523|P1|Participant Flow|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240274|NCT01069523|O2|Outcome|Guanfacine|Blinded guanfacine capsule
240275|NCT01069523|O1|Outcome|Placebo|Pill placebo
240276|NCT01069523|O2|Outcome|Guanfacine|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240277|NCT01069523|O1|Outcome|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240278|NCT01069523|E2|Reported Event|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240279|NCT01069523|E1|Reported Event|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
240280|NCT01069484|B3|Baseline|Total|Total of all reporting groups
240281|NCT01069484|B2|Baseline|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
240282|NCT01069484|B1|Baseline|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
240313|NCT01069289|P1|Participant Flow|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240283|NCT01069484|P2|Participant Flow|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.
240284|NCT01069484|P1|Participant Flow|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
240285|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
240286|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
240287|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
240288|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
240289|NCT01069484|E2|Reported Event|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
240290|NCT01069484|E1|Reported Event|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
240291|NCT01069419|B1|Baseline|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240292|NCT01069419|P1|Participant Flow|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240293|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240294|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240295|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240296|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240297|NCT01069419|E1|Reported Event|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
240298|NCT01069341|B1|Baseline|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
240299|NCT01069341|P1|Participant Flow|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
240300|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240301|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240302|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240303|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240304|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240305|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240306|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240307|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
240308|NCT01069341|E1|Reported Event|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
240309|NCT01069289|B3|Baseline|Total|Total of all reporting groups
240310|NCT01069289|B2|Baseline|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240311|NCT01069289|B1|Baseline|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240312|NCT01069289|P2|Participant Flow|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240970|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240971|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240315|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240316|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240317|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240318|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240319|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240320|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240321|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240322|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240323|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240324|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240325|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240326|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240327|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240328|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240329|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240330|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240331|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240332|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240333|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240334|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240335|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240336|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240337|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240338|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240339|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240340|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240341|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240342|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240343|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240344|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240345|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240346|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240347|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240348|NCT01069289|E2|Reported Event|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
240349|NCT01069289|E1|Reported Event|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
240350|NCT01069172|B1|Baseline|FS Laser Surgery and CCC Surgery|"Each eye underwent either:~Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).~OR~Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
240351|NCT01069172|P2|Participant Flow|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
240352|NCT01069172|P1|Participant Flow|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
240353|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
240354|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
240658|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240355|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
240356|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
240357|NCT01069172|E2|Reported Event|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
240358|NCT01069172|E1|Reported Event|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
240359|NCT01069120|B3|Baseline|Total|Total of all reporting groups
240360|NCT01069120|B2|Baseline|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
240361|NCT01069120|B1|Baseline|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
240362|NCT01069120|P1|Participant Flow|Proellex®|25 or 50 mg capsules once per day
240363|NCT01069120|O2|Outcome|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
240364|NCT01069120|O1|Outcome|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
240365|NCT01069120|E2|Reported Event|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
240366|NCT01069120|E1|Reported Event|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
240367|NCT01069003|B4|Baseline|Total|Total of all reporting groups
240368|NCT01069003|B3|Baseline|Surveillance Arm|Non randomized subjects followed for total of 24 months
240369|NCT01069003|B2|Baseline|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240370|NCT01069003|B1|Baseline|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240371|NCT01069003|P3|Participant Flow|Surveillance Arm|Non randomized subjects followed for total of 24 months
240372|NCT01069003|P2|Participant Flow|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240373|NCT01069003|P1|Participant Flow|Placebo|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240374|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
240375|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240376|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240377|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
240378|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240379|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240380|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
240381|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240382|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240383|NCT01069003|E3|Reported Event|Surveillance Arm|Non randomized subjects followed through 24 months
240529|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240384|NCT01069003|E2|Reported Event|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
240385|NCT01069003|E1|Reported Event|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
240386|NCT01068964|B3|Baseline|Total|Total of all reporting groups
240387|NCT01068964|B2|Baseline|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
240388|NCT01068964|B1|Baseline|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
240389|NCT01068964|P2|Participant Flow|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
240390|NCT01068964|P1|Participant Flow|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
240391|NCT01068964|O2|Outcome|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
240392|NCT01068964|O1|Outcome|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
240393|NCT01068964|E2|Reported Event|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
240394|NCT01068964|E1|Reported Event|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
240395|NCT01068912|B4|Baseline|Total|Total of all reporting groups
240396|NCT01068912|B3|Baseline|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
240397|NCT01068912|B2|Baseline|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
240398|NCT01068912|B1|Baseline|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
240399|NCT01068912|P3|Participant Flow|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
240400|NCT01068912|P2|Participant Flow|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
240401|NCT01068912|P1|Participant Flow|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
240402|NCT01068912|O3|Outcome|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
240403|NCT01068912|O2|Outcome|2: High Dose Favipiravir|Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
240404|NCT01068912|O1|Outcome|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
240405|NCT01068912|E3|Reported Event|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
240406|NCT01068912|E2|Reported Event|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
240407|NCT01068912|E1|Reported Event|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
240408|NCT01068860|B11|Baseline|Total|Total of all reporting groups
240409|NCT01068860|B10|Baseline|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240410|NCT01068860|B9|Baseline|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240411|NCT01068860|B8|Baseline|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240412|NCT01068860|B7|Baseline|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240413|NCT01068860|B6|Baseline|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240414|NCT01068860|B5|Baseline|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240415|NCT01068860|B4|Baseline|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240530|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240416|NCT01068860|B3|Baseline|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240417|NCT01068860|B2|Baseline|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240418|NCT01068860|B1|Baseline|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240419|NCT01068860|P10|Participant Flow|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240420|NCT01068860|P9|Participant Flow|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240421|NCT01068860|P8|Participant Flow|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240422|NCT01068860|P7|Participant Flow|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240423|NCT01068860|P6|Participant Flow|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240424|NCT01068860|P5|Participant Flow|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240425|NCT01068860|P4|Participant Flow|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240426|NCT01068860|P3|Participant Flow|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240427|NCT01068860|P2|Participant Flow|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240428|NCT01068860|P1|Participant Flow|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240429|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240430|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240431|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240432|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240433|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240453|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240434|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240435|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240436|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240437|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240438|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240439|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240440|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240441|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240442|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240443|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240444|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240445|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240446|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240447|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240448|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240449|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240450|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240451|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240452|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240972|NCT01067976|O1|Outcome|CMRM vs UMRM|
240454|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240455|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240456|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240457|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240458|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240459|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240460|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240461|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240462|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240463|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240464|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240465|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240466|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240467|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240468|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240469|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240470|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240471|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240472|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240973|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240473|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240474|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240475|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240476|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240477|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240478|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240479|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240480|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240481|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240482|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240483|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240484|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240485|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240486|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240487|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240488|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240489|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240490|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240491|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240492|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240493|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240494|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240495|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240496|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240497|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240498|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240499|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240500|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240501|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240502|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240503|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240504|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240505|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240506|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240507|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240508|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240509|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240510|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240511|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240512|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240513|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240514|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240515|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240516|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240517|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240518|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240519|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240520|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240521|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240522|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240523|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240524|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240525|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240526|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240527|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240528|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240610|NCT01068769|B1|Baseline|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
240974|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240531|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240532|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240533|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240534|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240535|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240536|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240537|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240538|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240539|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240540|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240541|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240542|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240543|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240544|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240545|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240546|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240547|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240548|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240611|NCT01068769|P1|Participant Flow|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
240975|NCT01067976|O1|Outcome|CMRM vs UMRM|
240549|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240550|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240551|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240552|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240553|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240554|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240555|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240556|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240557|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240558|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240559|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240560|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240561|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240562|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240563|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240564|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240565|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240566|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240612|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
240613|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
240567|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240568|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240569|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240570|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240571|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240572|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240573|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240574|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240575|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240576|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240577|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240578|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240579|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240580|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240581|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240582|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240583|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240584|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240585|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240586|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240587|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240588|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240589|NCT01068860|E10|Reported Event|Placebo in Patients With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240590|NCT01068860|E9|Reported Event|Canakinumab 150 mg in Patients With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
240591|NCT01068860|E8|Reported Event|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240592|NCT01068860|E7|Reported Event|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
240593|NCT01068860|E6|Reported Event|Placebo + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240594|NCT01068860|E5|Reported Event|Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240595|NCT01068860|E4|Reported Event|Placebo + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240596|NCT01068860|E3|Reported Event|Canakinumab 150 mg + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
240597|NCT01068860|E2|Reported Event|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240598|NCT01068860|E1|Reported Event|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
240599|NCT01068821|B3|Baseline|Total|Total of all reporting groups
240600|NCT01068821|B2|Baseline|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240601|NCT01068821|B1|Baseline|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240602|NCT01068821|P2|Participant Flow|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240603|NCT01068821|P1|Participant Flow|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240604|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
240605|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
240606|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
240607|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
240608|NCT01068821|E2|Reported Event|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240609|NCT01068821|E1|Reported Event|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
240976|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240616|NCT01068743|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment C (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment A (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment B (period 4): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition.
240617|NCT01068743|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment B (period 2): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment D (period 3): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment A (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
240618|NCT01068743|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment A (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment C (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment D (period 4): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
240619|NCT01068743|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment D (period 2): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment B (period 3): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment C (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition.
240620|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240621|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240622|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240623|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240624|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240625|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240626|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240627|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240628|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240629|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240630|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240631|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240632|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240633|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240634|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240635|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240636|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240637|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240638|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240639|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240640|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240641|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240642|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240643|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240644|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240645|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240646|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240647|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240648|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240649|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240650|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240651|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240652|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240653|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240654|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240655|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240977|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240662|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240663|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240664|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
240665|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition.
240666|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240667|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
240668|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240669|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240670|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240671|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240672|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240673|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240674|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240675|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240676|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240677|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240678|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240679|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240680|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240681|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240682|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240683|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240684|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240685|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240686|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240687|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240688|NCT01068743|E4|Reported Event|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
240689|NCT01068743|E3|Reported Event|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
240690|NCT01068743|E2|Reported Event|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
240691|NCT01068743|E1|Reported Event|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
240692|NCT01068730|B1|Baseline|All Enrolled and Treated Participants|Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
240693|NCT01068730|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
240694|NCT01068730|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
240695|NCT01068730|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
240696|NCT01068730|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
240697|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240698|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240699|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240700|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240701|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240702|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240703|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240704|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240705|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240706|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240707|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240708|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240709|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240710|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240711|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240712|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240713|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240714|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240715|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240716|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240717|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240718|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240719|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240720|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240721|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240722|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240723|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240724|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240725|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
240726|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
240727|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
240728|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
240729|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
240730|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
240731|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
240732|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
240733|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
240734|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
240735|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
240736|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
240737|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
240738|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
240739|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
240740|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
240741|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
240742|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
240743|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
240744|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
240745|NCT01068730|E4|Reported Event|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
240746|NCT01068730|E3|Reported Event|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
240747|NCT01068730|E2|Reported Event|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
240748|NCT01068730|E1|Reported Event|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
240749|NCT01068717|B1|Baseline|All Treated|All participants who received study medication.
240750|NCT01068717|P4|Participant Flow|Treatment Schedule DCAB|(Treatment D) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state.
240751|NCT01068717|P3|Participant Flow|Treatment Schedule CBDA|(Treatment C) A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fed state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state.
240752|NCT01068717|P2|Participant Flow|Treatment Schedule BACD|(Treatment B) A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state.
240753|NCT01068717|P1|Participant Flow|Treatment Schedule ADBC|(Treatment A) A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state.
240754|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240755|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240756|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240757|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240758|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240759|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240760|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240761|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240762|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240763|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240764|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240765|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240766|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240767|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240768|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240769|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240770|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240771|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240772|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240773|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240774|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240775|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240776|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240777|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240778|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240779|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240780|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240781|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240782|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240783|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240784|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240785|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240786|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240787|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240788|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240789|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240790|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240791|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240792|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240793|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240794|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240795|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240796|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240797|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240798|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240799|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
240800|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
240801|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
240802|NCT01068717|E4|Reported Event|Fed: 2.5mg Saxa/500mg Metformin FDC|
240803|NCT01068717|E3|Reported Event|Fed: 2.5mg Onglyza + 500mg Glucophage|
240804|NCT01068717|E2|Reported Event|Fasted: 2.5mg Saxa/500mg Metformin FDC|
240805|NCT01068717|E1|Reported Event|Fasted: 2.5mg Onglyza + 500mg Glucophage|
240806|NCT01068678|B3|Baseline|Total|Total of all reporting groups
240807|NCT01068678|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240808|NCT01068678|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240809|NCT01068678|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240810|NCT01068678|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240811|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240812|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240813|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240814|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240815|NCT01068678|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240816|NCT01068678|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240817|NCT01068665|B3|Baseline|Total|Total of all reporting groups
240818|NCT01068665|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240819|NCT01068665|B1|Baseline|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240820|NCT01068665|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240821|NCT01068665|P1|Participant Flow|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240822|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240823|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240824|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240825|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240826|NCT01068665|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240827|NCT01068665|E1|Reported Event|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
240828|NCT01068652|B3|Baseline|Total|Total of all reporting groups
240829|NCT01068652|B2|Baseline|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240830|NCT01068652|B1|Baseline|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240831|NCT01068652|P2|Participant Flow|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240832|NCT01068652|P1|Participant Flow|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240833|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240834|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240835|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240836|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240837|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240838|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240839|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240840|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240841|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240857|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240842|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240843|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240844|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240845|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240846|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240847|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240848|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240849|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240850|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240851|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240852|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240853|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240854|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240855|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240856|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240891|NCT01068600|P2|Participant Flow|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240858|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240859|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240860|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240861|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240862|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240863|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240864|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240865|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240866|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240867|NCT01068652|E2|Reported Event|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
240868|NCT01068652|E1|Reported Event|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
240869|NCT01068626|B3|Baseline|Total|Total of all reporting groups
240870|NCT01068626|B2|Baseline|Placebo for Rosuvastatin|
240871|NCT01068626|B1|Baseline|Rosuvastatin|
240872|NCT01068626|P2|Participant Flow|Placebo for Rosuvastatin|
240873|NCT01068626|P1|Participant Flow|Rosuvastatin|
240874|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240875|NCT01068626|O1|Outcome|Rosuvastatin|
240876|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240877|NCT01068626|O1|Outcome|Rosuvastatin|
240878|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240879|NCT01068626|O1|Outcome|Rosuvastatin|
240880|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240881|NCT01068626|O1|Outcome|Rosuvastatin|
240882|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240883|NCT01068626|O1|Outcome|Rosuvastatin|
240884|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
240885|NCT01068626|O1|Outcome|Rosuvastatin|
240886|NCT01068626|E2|Reported Event|Placebo for Rosuvastatin|
240887|NCT01068626|E1|Reported Event|Rosuvastatin|
240888|NCT01068600|B3|Baseline|Total|Total of all reporting groups
240889|NCT01068600|B2|Baseline|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240890|NCT01068600|B1|Baseline|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240892|NCT01068600|P1|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240893|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240894|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240895|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240896|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240897|NCT01068600|E2|Reported Event|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240898|NCT01068600|E1|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
240899|NCT01068548|B3|Baseline|Total|Total of all reporting groups
240900|NCT01068548|B2|Baseline|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
240901|NCT01068548|B1|Baseline|Arm 1|pre-implementation of computer based intervention
240902|NCT01068548|P2|Participant Flow|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
240903|NCT01068548|P1|Participant Flow|Arm 1|pre-implementation of computer based intervention
240904|NCT01068548|O2|Outcome|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
240905|NCT01068548|O1|Outcome|Arm 1|pre-implementation of computer based intervention
240906|NCT01068548|E2|Reported Event|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
240907|NCT01068548|E1|Reported Event|Arm 1|pre-implementation of computer based intervention
240908|NCT01068509|B4|Baseline|Total|Total of all reporting groups
240909|NCT01068509|B3|Baseline|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240910|NCT01068509|B2|Baseline|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240911|NCT01068509|B1|Baseline|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
240912|NCT01068509|P3|Participant Flow|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240913|NCT01068509|P2|Participant Flow|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240914|NCT01068509|P1|Participant Flow|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
240915|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240916|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240917|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240918|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240919|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240920|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240978|NCT01067976|O1|Outcome|CMRM vs UMRM|
240922|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240923|NCT01068509|E3|Reported Event|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
240924|NCT01068509|E2|Reported Event|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
240925|NCT01068509|E1|Reported Event|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
240926|NCT01068418|B1|Baseline|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
240927|NCT01068418|P1|Participant Flow|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
240928|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
240929|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
240930|NCT01068418|E1|Reported Event|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
240931|NCT01068158|B3|Baseline|Total|Total of all reporting groups
240932|NCT01068158|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240933|NCT01068158|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240934|NCT01068158|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240935|NCT01068158|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240936|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240937|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240938|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240939|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240940|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240941|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240942|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240943|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240944|NCT01068158|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
240945|NCT01068158|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
240946|NCT01067976|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
240947|NCT01067976|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
240948|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
240949|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|
240950|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
240951|NCT01067976|O1|Outcome|CMRM|
240952|NCT01067976|O1|Outcome|CMRM|
240953|NCT01067976|O1|Outcome|CMRM|
240954|NCT01067976|O1|Outcome|CMRM vs UMRM|
240955|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240956|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240957|NCT01067976|O1|Outcome|CMRM vs UMRM|
240958|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240959|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240960|NCT01067976|O1|Outcome|CMRM vs UMRM|
240961|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240962|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240963|NCT01067976|O1|Outcome|CMRM vs UMRM|
240964|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
240965|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
240966|NCT01067976|O1|Outcome|CMRM vs UMRM|
240991|NCT01067976|O2|Outcome|CMRM|After the administration of study drug, enhanced breast MRI were performed.
240992|NCT01067976|O1|Outcome|UMRM|Before the administration of study drug unenhanced breast MRI (UMRM) were performed.
240993|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
240994|NCT01067976|O2|Outcome|CMRM vs XRM|
240995|NCT01067976|O1|Outcome|CMRM vs UMRM|
240996|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
240997|NCT01067976|O2|Outcome|CMRM vs XRM|
240998|NCT01067976|O1|Outcome|CMRM vs UMRM|
240999|NCT01067976|O1|Outcome|CMRM|
241000|NCT01067976|O1|Outcome|CMRM|
241001|NCT01067976|O2|Outcome|CMRM|
241002|NCT01067976|O1|Outcome|UMRM|
241003|NCT01067976|O1|Outcome|CMRM vs UMRM|
241004|NCT01067976|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
241005|NCT01067846|B3|Baseline|Total|Total of all reporting groups
241006|NCT01067846|B2|Baseline|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241007|NCT01067846|B1|Baseline|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241008|NCT01067846|P2|Participant Flow|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241009|NCT01067846|P1|Participant Flow|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241010|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241011|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241012|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241013|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241014|NCT01067846|E2|Reported Event|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241015|NCT01067846|E1|Reported Event|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
241016|NCT01067781|B5|Baseline|Total|Total of all reporting groups
241017|NCT01067781|B4|Baseline|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241018|NCT01067781|B3|Baseline|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241019|NCT01067781|B2|Baseline|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241020|NCT01067781|B1|Baseline|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241021|NCT01067781|P4|Participant Flow|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241022|NCT01067781|P3|Participant Flow|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241023|NCT01067781|P2|Participant Flow|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241024|NCT01067781|P1|Participant Flow|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241025|NCT01067781|O2|Outcome|Group 3 & 4 Combined: Placebo Patch (0µg LT)|with or without swabbing
241026|NCT01067781|O1|Outcome|Group 1 & 2 Combined: 37.5µg LT Patch|with or without swabbing
241027|NCT01067781|E4|Reported Event|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241028|NCT01067781|E3|Reported Event|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
241029|NCT01067781|E2|Reported Event|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241030|NCT01067781|E1|Reported Event|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
241031|NCT01067768|B3|Baseline|Total|Total of all reporting groups
241032|NCT01067768|B2|Baseline|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
241033|NCT01067768|B1|Baseline|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
241034|NCT01067768|P2|Participant Flow|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
241035|NCT01067768|P1|Participant Flow|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
241036|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
241037|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
241038|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
241039|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
241040|NCT01067768|E2|Reported Event|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
241041|NCT01067768|E1|Reported Event|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
241042|NCT01067716|B4|Baseline|Total|Total of all reporting groups
241043|NCT01067716|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241044|NCT01067716|B2|Baseline|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241045|NCT01067716|B1|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241046|NCT01067716|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241047|NCT01067716|P2|Participant Flow|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241048|NCT01067716|P1|Participant Flow|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241049|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241050|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241051|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241052|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241053|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241054|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241055|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241056|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241057|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241058|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241059|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241060|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241061|NCT01067716|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
241062|NCT01067716|E2|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
241063|NCT01067716|E1|Reported Event|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
241064|NCT01067456|B3|Baseline|Total|Total of all reporting groups
241157|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
243092|NCT01059994|P3|Participant Flow|Sildenafil Placebo Older|Sildenafil placebo: Oral, daily, 1 week.
241065|NCT01067456|B2|Baseline|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
241066|NCT01067456|B1|Baseline|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
241067|NCT01067456|P2|Participant Flow|Comprehensive Cardiothoracic CT Arm|Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
241068|NCT01067456|P1|Participant Flow|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
241069|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
241070|NCT01067456|O1|Outcome|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
241071|NCT01067456|E2|Reported Event|Comprehensive Cardiothoracic CT Arm|Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
241072|NCT01067456|E1|Reported Event|Dedicated CT Arm|Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
241073|NCT01067352|B4|Baseline|Total|Total of all reporting groups
241074|NCT01067352|B3|Baseline|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241075|NCT01067352|B2|Baseline|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241076|NCT01067352|B1|Baseline|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241077|NCT01067352|P3|Participant Flow|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241078|NCT01067352|P2|Participant Flow|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241079|NCT01067352|P1|Participant Flow|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241080|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241081|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241082|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241083|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241084|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241085|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241086|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241087|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241088|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241089|NCT01067352|E3|Reported Event|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241090|NCT01067352|E2|Reported Event|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
241158|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241091|NCT01067352|E1|Reported Event|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
241092|NCT01067326|B3|Baseline|Total|Total of all reporting groups
241093|NCT01067326|B2|Baseline|Placebo|"1 pill per day by mouth for 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
241094|NCT01067326|B1|Baseline|Aliskiren|"150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
241095|NCT01067326|P2|Participant Flow|Placebo|1 pill per day by mouth for 4 months.
241096|NCT01067326|P1|Participant Flow|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241097|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
241098|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241099|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
241100|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241101|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
241102|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241103|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
241104|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241105|NCT01067326|E2|Reported Event|Placebo|1 pill per day by mouth for 4 months.
241106|NCT01067326|E1|Reported Event|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
241107|NCT01067105|B1|Baseline|Ciclesonide|ciclesonide HFA 160 μg once daily
241108|NCT01067105|P1|Participant Flow|Ciclesonide|ciclesonide HFA 160 μg once daily
241109|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241110|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241111|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241112|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241113|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241114|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241115|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241116|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241117|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241118|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241119|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241120|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241121|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241122|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
241123|NCT01067105|E1|Reported Event|Ciclesonide|ciclesonide HFA 160 μg once daily
241124|NCT01066923|B5|Baseline|Total|Total of all reporting groups
241125|NCT01066923|B4|Baseline|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
241126|NCT01066923|B3|Baseline|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
241127|NCT01066923|B2|Baseline|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
241128|NCT01066923|B1|Baseline|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
241129|NCT01066923|P4|Participant Flow|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
241130|NCT01066923|P3|Participant Flow|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
241131|NCT01066923|P2|Participant Flow|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
241132|NCT01066923|P1|Participant Flow|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
241356|NCT01066793|B7|Baseline|Total|Total of all reporting groups
241133|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
241134|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
241135|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
241136|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
241137|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
241138|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
241139|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
241140|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
241141|NCT01066923|E4|Reported Event|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
241142|NCT01066923|E3|Reported Event|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
241143|NCT01066923|E2|Reported Event|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
241144|NCT01066923|E1|Reported Event|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
241145|NCT01066871|B5|Baseline|Total|Total of all reporting groups
241146|NCT01066871|B4|Baseline|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241147|NCT01066871|B3|Baseline|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241148|NCT01066871|B2|Baseline|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241149|NCT01066871|B1|Baseline|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241150|NCT01066871|P4|Participant Flow|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241151|NCT01066871|P3|Participant Flow|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241152|NCT01066871|P2|Participant Flow|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241153|NCT01066871|P1|Participant Flow|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241154|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241155|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241156|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
243093|NCT01059994|P2|Participant Flow|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
241159|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241160|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241161|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241162|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241163|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241164|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241165|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241166|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241167|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241168|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241169|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241170|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241171|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241172|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241173|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241174|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241175|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241176|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241177|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241178|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241179|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241180|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241181|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241182|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241183|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241184|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241185|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241186|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241187|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241188|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241189|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241190|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241191|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241192|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241193|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241194|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241195|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241196|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241197|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241198|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin AS902330 was administered as intra-articular injection once every week for 3 consecutive weeks.
241199|NCT01066871|O3|Outcome|AS902330 100 mcg|AS902330 was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241200|NCT01066871|O2|Outcome|AS902330 30 mcg|AS902330 was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241201|NCT01066871|O1|Outcome|AS902330 10 mcg|AS902330 was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241202|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241203|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241204|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241205|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241206|NCT01066871|E4|Reported Event|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
241207|NCT01066871|E3|Reported Event|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
241208|NCT01066871|E2|Reported Event|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
241209|NCT01066871|E1|Reported Event|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
241210|NCT01066819|B7|Baseline|Total|Total of all reporting groups
241211|NCT01066819|B6|Baseline|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241212|NCT01066819|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241213|NCT01066819|B4|Baseline|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241214|NCT01066819|B3|Baseline|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241215|NCT01066819|B2|Baseline|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241216|NCT01066819|B1|Baseline|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241217|NCT01066819|P6|Participant Flow|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241218|NCT01066819|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241219|NCT01066819|P4|Participant Flow|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241220|NCT01066819|P3|Participant Flow|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241221|NCT01066819|P2|Participant Flow|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241222|NCT01066819|P1|Participant Flow|Genotype 1 (G1)|Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
241223|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241224|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241225|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241533|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241226|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241227|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241228|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241229|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241230|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241231|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241232|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241233|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241234|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241235|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241236|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241237|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241238|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241239|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241240|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241241|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241242|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241243|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241244|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241245|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241246|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241247|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241248|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241249|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241250|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241251|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241252|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241253|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241254|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241255|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241256|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241257|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241258|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241259|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241260|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241261|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241262|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241263|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241264|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241265|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241266|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241267|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241268|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241269|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241270|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241271|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241272|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241273|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241274|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241275|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241276|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241277|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241278|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241279|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241280|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241281|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241282|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241283|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241284|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241285|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241286|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241287|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241288|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241289|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241290|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241291|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241292|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241293|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241294|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241295|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241296|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241297|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241298|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241299|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241300|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241301|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241302|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241303|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241304|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241305|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241306|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241307|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241308|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241309|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241310|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241311|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241312|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241313|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241314|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241315|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241316|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241317|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241318|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241319|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241320|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241321|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241322|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241323|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241324|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241325|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241326|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241327|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241328|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241329|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241330|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241331|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241332|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241333|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241334|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241335|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241336|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241337|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241338|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241339|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241340|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241341|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241342|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241343|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241344|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241345|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241346|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241347|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241348|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241349|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241350|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241351|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241352|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241353|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241354|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible Participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241355|NCT01066819|E1|Reported Event|Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)|Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
241357|NCT01066793|B6|Baseline|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241358|NCT01066793|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241359|NCT01066793|B4|Baseline|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241360|NCT01066793|B3|Baseline|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241361|NCT01066793|B2|Baseline|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241362|NCT01066793|B1|Baseline|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241363|NCT01066793|P6|Participant Flow|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241364|NCT01066793|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241365|NCT01066793|P4|Participant Flow|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241366|NCT01066793|P3|Participant Flow|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241367|NCT01066793|P2|Participant Flow|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241368|NCT01066793|P1|Participant Flow|Genotype 1 (G1)|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon [PEG-IFN] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
241369|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241370|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241371|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241372|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241373|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241374|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241375|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241376|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241377|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241378|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241379|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241380|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241381|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241534|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
249287|NCT01037244|O4|Outcome|Placebo|Placebo tablets
241382|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241383|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241384|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241385|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241386|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241387|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241388|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241389|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241390|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241391|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241392|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241393|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241394|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241395|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241396|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241397|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241398|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241399|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241400|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241401|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241402|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241403|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241404|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241405|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241406|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241407|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
249288|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
241408|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241409|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241410|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241411|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241412|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241413|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241414|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241415|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241416|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241417|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241418|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241419|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241420|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241421|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241422|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241423|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241424|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241425|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241426|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241427|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241428|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241429|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241430|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241431|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241432|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241433|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
249289|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
241434|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241435|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241436|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241437|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241438|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241439|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241440|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241441|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241442|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241443|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241444|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241445|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241446|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241447|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241448|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241449|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241450|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241451|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241452|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241453|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241454|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241455|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241456|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241457|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241458|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241459|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
249290|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
241460|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241461|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241462|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241463|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241464|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241465|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241466|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241467|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241468|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241469|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241470|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241471|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241472|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241473|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241474|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241475|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241476|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241477|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241478|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241479|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241480|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241481|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241482|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241483|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241484|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241485|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
249291|NCT01037244|O4|Outcome|Placebo|Placebo tablets
241486|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241487|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241488|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241489|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241490|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241491|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241492|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241493|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241494|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241495|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241496|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241497|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241498|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241499|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241500|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241501|NCT01066793|E6|Reported Event|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241502|NCT01066793|E5|Reported Event|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241503|NCT01066793|E4|Reported Event|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241504|NCT01066793|E3|Reported Event|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241505|NCT01066793|E2|Reported Event|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241506|NCT01066793|E1|Reported Event|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
241507|NCT01066780|B1|Baseline|ClearVoice|
241508|NCT01066780|P2|Participant Flow|Group B: Received ClearVoice HIGH Followed by MEDIUM|Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
241509|NCT01066780|P1|Participant Flow|Group A: Received ClearVoice MEDIUM Followed by HIGH|Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.
241510|NCT01066780|O1|Outcome|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
241511|NCT01066780|E1|Reported Event|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
241512|NCT01066624|B4|Baseline|Total|Total of all reporting groups
241513|NCT01066624|B3|Baseline|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
241535|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
249292|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
241514|NCT01066624|B2|Baseline|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
241515|NCT01066624|B1|Baseline|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
241516|NCT01066624|P3|Participant Flow|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
241517|NCT01066624|P2|Participant Flow|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
241518|NCT01066624|P1|Participant Flow|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
241519|NCT01066624|O3|Outcome|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
241520|NCT01066624|O2|Outcome|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
241521|NCT01066624|O1|Outcome|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
241522|NCT01066624|E3|Reported Event|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
241523|NCT01066624|E2|Reported Event|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
241524|NCT01066624|E1|Reported Event|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
241525|NCT01066585|B3|Baseline|Total|Total of all reporting groups
241526|NCT01066585|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
241527|NCT01066585|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241528|NCT01066585|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
241529|NCT01066585|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241530|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
241531|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241532|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
249293|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
241536|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
241537|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241538|NCT01066585|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
241539|NCT01066585|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
241540|NCT01066546|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241541|NCT01066546|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241542|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241543|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241544|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241545|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241546|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241547|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241548|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241549|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241550|NCT01066546|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
241551|NCT01066520|B4|Baseline|Total|Total of all reporting groups
241552|NCT01066520|B3|Baseline|Diclofenac Gel|Diclofenac Gel 2g, 3 times daily topical during 14 days
241553|NCT01066520|B2|Baseline|Traumeel S Gel|Traumeel S Gel 2g, 3 times daily topical during 14 days
241554|NCT01066520|B1|Baseline|Traumeel S Ointment|Traumeel S Ointment 2g, 3 times daily topical during 14 days
241555|NCT01066520|P3|Participant Flow|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241556|NCT01066520|P2|Participant Flow|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241557|NCT01066520|P1|Participant Flow|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241558|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241559|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241560|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241561|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241562|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241563|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241564|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241565|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241566|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241567|NCT01066520|E3|Reported Event|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241568|NCT01066520|E2|Reported Event|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241569|NCT01066520|E1|Reported Event|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
241622|NCT01065714|P1|Participant Flow|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
241570|NCT01066039|B1|Baseline|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241571|NCT01066039|P1|Participant Flow|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241572|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241573|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241574|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241575|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241576|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241577|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241578|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241579|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241580|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241581|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241582|NCT01066039|E1|Reported Event|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
241583|NCT01066000|B1|Baseline|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241584|NCT01066000|P1|Participant Flow|Mircera|Eligible participants received methoxy polyethylene glycol-epoetin beta (Mircera) intravenously (IV), once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 microgram (mcg) which was based on the Epoetin dose of<8000, 8000-16000, or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
241585|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241586|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241587|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241588|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241589|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
249294|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
241590|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241591|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241592|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241593|NCT01066000|E1|Reported Event|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
241594|NCT01065844|B1|Baseline|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
241595|NCT01065844|P1|Participant Flow|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
241596|NCT01065844|O1|Outcome|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
241597|NCT01065844|E1|Reported Event|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
241598|NCT01065779|B1|Baseline|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241599|NCT01065779|P1|Participant Flow|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241600|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241601|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241602|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241603|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241604|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241605|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241606|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241607|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241608|NCT01065779|E1|Reported Event|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
241609|NCT01065766|B1|Baseline|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241610|NCT01065766|P1|Participant Flow|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241611|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241612|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241613|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241614|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241615|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241616|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241617|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241618|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241619|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241620|NCT01065766|E1|Reported Event|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
241621|NCT01065714|B1|Baseline|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
241623|NCT01065714|O1|Outcome|Skin Hydration With Hydrogel|Parallel designed study. Split body treatment. Hydrogel vehicle applied to targeted area one side of body. Skin Hydration measured by 5 Corneometer readings.
241624|NCT01065714|O1|Outcome|Skin Hydration With Eucerin|Parallel designed study. Split body treatment. Five corneometer readings were taken on the targeted area of one half of the body on which Eucerin Lotion was applied.
241625|NCT01065714|O1|Outcome|Skin Barrier Function With Hydrogel Vehicle|Trans epidural water loss measurements on target areas of body side treated with Hydrogel vehicle
241626|NCT01065714|O1|Outcome|Skin Barrier Function With Eucerin Lotion|Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
241627|NCT01065714|E1|Reported Event|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
241628|NCT01065597|B1|Baseline|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241629|NCT01065597|P1|Participant Flow|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241630|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241631|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241632|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241633|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241634|NCT01065597|E1|Reported Event|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
241635|NCT01065558|B1|Baseline|Ecopipam|
241636|NCT01065558|P1|Participant Flow|Ecopipam (12.5- 200 mg/Day)|"Patients were given ecopipapm over an 11 day period as follows:~day 1 12.5 mg/day day 2-3 25 mg/day day 4-5 50 mg/day day 6-9 100 mg/day day 9-11 200 mg/day~Note: Doses were reduced as necessary to a previously tolerated dose if paitents reached doses that were not safely tolerable."
241637|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
241638|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
241639|NCT01065558|E1|Reported Event|Ecopipam Treated Patients|
241640|NCT01065506|B3|Baseline|Total|Total of all reporting groups
241641|NCT01065506|B2|Baseline|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
241642|NCT01065506|B1|Baseline|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
241643|NCT01065506|P2|Participant Flow|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)"
241644|NCT01065506|P1|Participant Flow|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals"
241645|NCT01065506|O2|Outcome|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
241646|NCT01065506|O1|Outcome|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
241647|NCT01065506|E2|Reported Event|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
241648|NCT01065506|E1|Reported Event|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
241649|NCT01065454|B5|Baseline|Total|Total of all reporting groups
241650|NCT01065454|B4|Baseline|Placebo|Participants received placebo tid.
241651|NCT01065454|B3|Baseline|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241652|NCT01065454|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241653|NCT01065454|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241654|NCT01065454|P4|Participant Flow|Placebo|Participants received placebo tid.
241655|NCT01065454|P3|Participant Flow|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241656|NCT01065454|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241657|NCT01065454|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241658|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241659|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241660|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241661|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241662|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241663|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241664|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241665|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241666|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241667|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241668|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241669|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241670|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241671|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241672|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241673|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241674|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241675|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241676|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241677|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241678|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241679|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241680|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241681|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241682|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241683|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241684|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241685|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241686|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241687|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241688|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241689|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241690|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241691|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241692|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241693|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241694|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241695|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241696|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241697|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241698|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241699|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241700|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241701|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241702|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241703|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241704|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241705|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241706|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241707|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241708|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241709|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241710|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241711|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241712|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241713|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241714|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241715|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241716|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241717|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241718|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241719|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241720|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241721|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241722|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241723|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241724|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241725|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241726|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241727|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241728|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241729|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241730|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241731|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241732|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241733|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241734|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241735|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241736|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241737|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241738|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241739|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241740|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241741|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241742|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241743|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241744|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241745|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241746|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241747|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241748|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241749|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241750|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241751|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241752|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241753|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241754|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241755|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241756|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241757|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241758|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
241759|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
241760|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
241761|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241762|NCT01065454|E4|Reported Event|Placebo|Participants received placebo tid
241763|NCT01065454|E3|Reported Event|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose)
241764|NCT01065454|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg)
241765|NCT01065454|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
241766|NCT01065428|B3|Baseline|Total|Total of all reporting groups
241767|NCT01065428|B2|Baseline|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
241768|NCT01065428|B1|Baseline|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
241769|NCT01065428|P2|Participant Flow|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
241770|NCT01065428|P1|Participant Flow|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
241771|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
241772|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
241773|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
241774|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
241775|NCT01065428|E2|Reported Event|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
241776|NCT01065428|E1|Reported Event|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
241777|NCT01065350|B3|Baseline|Total|Total of all reporting groups
241778|NCT01065350|B2|Baseline|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose."
241779|NCT01065350|B1|Baseline|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241780|NCT01065350|P2|Participant Flow|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241781|NCT01065350|P1|Participant Flow|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241782|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241783|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241784|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241785|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241856|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
243094|NCT01059994|P1|Participant Flow|Sildenafil Placebo Young|Sildenafil placebo: Oral, daily, 1 week.
241786|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241787|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241788|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241789|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241790|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241791|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241792|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241793|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241794|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241795|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241796|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241797|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241798|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241799|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241800|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241801|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241802|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241803|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241804|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241805|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241806|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241807|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241808|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241809|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241810|NCT01065350|E2|Reported Event|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
241811|NCT01065350|E1|Reported Event|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
241812|NCT01065051|B3|Baseline|Total|Total of all reporting groups
241813|NCT01065051|B2|Baseline|Placebo|Participants received a single oral dose of 1 mg placebo.
241814|NCT01065051|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241815|NCT01065051|P2|Participant Flow|Placebo|Participants received a single oral dose of 1 mg placebo.
241816|NCT01065051|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241817|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241818|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241819|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241820|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241821|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241822|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241823|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241824|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241825|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241826|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241827|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241828|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241829|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241830|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241831|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241832|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241833|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241834|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241835|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241836|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241837|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
241838|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241839|NCT01065051|E2|Reported Event|Placebo|Participants received a single oral dose of 1 mg placebo.
241840|NCT01065051|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
241841|NCT01064947|B1|Baseline|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
241842|NCT01064947|P1|Participant Flow|All Participants|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
241843|NCT01064947|O1|Outcome|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
241844|NCT01064947|O1|Outcome|Participants With a Positive Culture at Day 1|
241845|NCT01064947|O1|Outcome|Participants With Positive Culture at Day 1|
241846|NCT01064947|O2|Outcome|Participants With a Positive Culture at Day 1|
241847|NCT01064947|O1|Outcome|All Participants at Day 1|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.
241848|NCT01064947|E1|Reported Event|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
241849|NCT01064882|B4|Baseline|Total|Total of all reporting groups
241850|NCT01064882|B3|Baseline|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241851|NCT01064882|B2|Baseline|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241852|NCT01064882|B1|Baseline|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241853|NCT01064882|P3|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241854|NCT01064882|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241855|NCT01064882|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241857|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241858|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241859|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241860|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241861|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241862|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241863|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241864|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241865|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241866|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241867|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241868|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241869|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241870|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241871|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241872|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241873|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241874|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241875|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241876|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241877|NCT01064882|E3|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
241878|NCT01064882|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
241879|NCT01064882|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
241880|NCT01064856|B3|Baseline|Total|Total of all reporting groups
241881|NCT01064856|B2|Baseline|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241882|NCT01064856|B1|Baseline|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241883|NCT01064856|P4|Participant Flow|Double-blind Placebo / Open-label Adalimumab|Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
241884|NCT01064856|P3|Participant Flow|Double-blind Adalimumab / Open-label Adalimumab|Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
241885|NCT01064856|P2|Participant Flow|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241886|NCT01064856|P1|Participant Flow|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241887|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241888|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241889|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241890|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241891|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241892|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241893|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241894|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241895|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241896|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241897|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241898|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241899|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241900|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241901|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241902|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241903|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241904|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241905|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241906|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241907|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241908|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241909|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241910|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241911|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241912|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241913|NCT01064856|E3|Reported Event|Any Adalimumab|All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
241914|NCT01064856|E2|Reported Event|Double-blind Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
241915|NCT01064856|E1|Reported Event|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
241916|NCT01064830|B3|Baseline|Total|Total of all reporting groups
241917|NCT01064830|B2|Baseline|Vehicle|
241918|NCT01064830|B1|Baseline|Cyclosporine Solution|
241919|NCT01064830|P2|Participant Flow|Vehicle|
241920|NCT01064830|P1|Participant Flow|Cyclosporine Solution|
241921|NCT01064830|O2|Outcome|Vehicle|vehicle
241922|NCT01064830|O1|Outcome|Cyclosporine Solution|cyclosporine solution
241923|NCT01064830|O2|Outcome|Vehicle|vehicle
241924|NCT01064830|O1|Outcome|Cyclosporine Solution|cyclosporine solution
241925|NCT01064830|E2|Reported Event|Vehicle|vehicle
241926|NCT01064830|E1|Reported Event|Cyclosporine Solution|cyclosporine solution
241927|NCT01064817|B3|Baseline|Total|Total of all reporting groups
241928|NCT01064817|B2|Baseline|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241929|NCT01064817|B1|Baseline|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241930|NCT01064817|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241931|NCT01064817|P1|Participant Flow|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241932|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241933|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241934|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241935|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241936|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241937|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241938|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241939|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241940|NCT01064817|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241941|NCT01064817|E1|Reported Event|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
241942|NCT01064739|B1|Baseline|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241943|NCT01064739|P1|Participant Flow|Fixed Sodium Diet +/- Fava Beans|Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions.
241944|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241999|NCT01064687|B4|Baseline|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
241945|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241946|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241947|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241948|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
241949|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241950|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241951|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241952|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241953|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241954|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241955|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241956|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
241957|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241958|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241959|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241960|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
241961|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241962|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241963|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241964|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241965|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241966|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241967|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241968|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241969|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241970|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241971|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241972|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241973|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241974|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241975|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241976|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241977|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241978|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241979|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241980|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241981|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241982|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241983|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241984|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241985|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241986|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241987|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241988|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241989|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241990|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241991|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241992|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241993|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241994|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
241995|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241996|NCT01064739|E2|Reported Event|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
241997|NCT01064739|E1|Reported Event|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
241998|NCT01064687|B5|Baseline|Total|Total of all reporting groups
242255|NCT01064362|E2|Reported Event|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
242000|NCT01064687|B3|Baseline|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242001|NCT01064687|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242002|NCT01064687|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242003|NCT01064687|P4|Participant Flow|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242004|NCT01064687|P3|Participant Flow|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242005|NCT01064687|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242006|NCT01064687|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242007|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242008|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242009|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242010|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242011|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242012|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242013|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242014|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242015|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242016|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242017|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242018|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242019|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242020|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242021|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242022|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242023|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242024|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242025|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242052|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242026|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242027|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242028|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242029|NCT01064687|O3|Outcome|Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242030|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242031|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242032|NCT01064687|O3|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242033|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242034|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242035|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242036|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242037|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242038|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242039|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242040|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242041|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242042|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242043|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242044|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242045|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242046|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242047|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242048|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242049|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242050|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242051|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242256|NCT01064362|E1|Reported Event|Fondaparinux|All dosages of fondaparinux
242257|NCT01064310|B3|Baseline|Total|Total of all reporting groups
242053|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242054|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242055|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242056|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242057|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242058|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242059|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242060|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242061|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242062|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242063|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242064|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242065|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242066|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242067|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242068|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242069|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242070|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242071|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242072|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242073|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242074|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242075|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242076|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242077|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242078|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242106|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242079|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242080|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242081|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242082|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242083|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242084|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242085|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242086|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242087|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242088|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242089|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242090|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242091|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242092|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242093|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242094|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242095|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242096|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242097|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242098|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242099|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242100|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242101|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242102|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242103|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242104|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242105|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242107|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242108|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242109|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242110|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242111|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242112|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242113|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242114|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242115|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242116|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242117|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242118|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242119|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242120|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242121|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242122|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242123|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242124|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242125|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242126|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242127|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242128|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242129|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242130|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242131|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242132|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242133|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242134|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242135|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242136|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242137|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242138|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242139|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242140|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242141|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242142|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242143|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242144|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242145|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242146|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242147|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242148|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242149|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242150|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242151|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242152|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242153|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242154|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242155|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242156|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242157|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242158|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242159|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242160|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
249295|NCT01037244|O4|Outcome|Placebo|Placebo tablets
242161|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242162|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242163|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242164|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242165|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242166|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242167|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242168|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242169|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
242170|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242171|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242172|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242173|NCT01064687|E9|Reported Event|Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
242174|NCT01064687|E8|Reported Event|Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
242175|NCT01064687|E7|Reported Event|Exenatide (Baseline Through 56 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242176|NCT01064687|E6|Reported Event|1.5 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242177|NCT01064687|E5|Reported Event|0.75 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242178|NCT01064687|E4|Reported Event|Placebo (Baseline Through 26 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242179|NCT01064687|E3|Reported Event|Exenatide (Baseline Through 26 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242180|NCT01064687|E2|Reported Event|1.5 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242181|NCT01064687|E1|Reported Event|0.75 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
242182|NCT01064622|B4|Baseline|Total|Total of all reporting groups
242183|NCT01064622|B3|Baseline|Phase I lead-in Patients|Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
242184|NCT01064622|B2|Baseline|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242208|NCT01064414|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.
242209|NCT01064414|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks.
249296|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
242185|NCT01064622|B1|Baseline|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242186|NCT01064622|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242187|NCT01064622|P1|Participant Flow|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242188|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242189|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242190|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242191|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242192|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242193|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242194|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242195|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242196|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242197|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242198|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242199|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242200|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242201|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242202|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242203|NCT01064622|E4|Reported Event|Phase II Crossover Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242204|NCT01064622|E3|Reported Event|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
242205|NCT01064622|E2|Reported Event|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
242206|NCT01064622|E1|Reported Event|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
242207|NCT01064414|B4|Baseline|Total|Total of all reporting groups
242210|NCT01064414|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks.
242211|NCT01064414|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
242212|NCT01064414|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
242213|NCT01064414|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
242214|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
242215|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
242216|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
242217|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
242218|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
242219|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
242220|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
242221|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
242222|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
242223|NCT01064414|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
242224|NCT01064414|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
242225|NCT01064414|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
242226|NCT01064414|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
242227|NCT01064414|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
242228|NCT01064414|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
242229|NCT01064401|B3|Baseline|Total|Total of all reporting groups
242230|NCT01064401|B2|Baseline|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
242231|NCT01064401|B1|Baseline|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242232|NCT01064401|P2|Participant Flow|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
242233|NCT01064401|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
242234|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
242235|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242236|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
242237|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242238|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
242239|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242240|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
242241|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242242|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
242243|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242244|NCT01064401|E2|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
242245|NCT01064401|E1|Reported Event|IFN Beta-1a 30 mcg|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
242246|NCT01064362|B3|Baseline|Total|Total of all reporting groups
242247|NCT01064362|B2|Baseline|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
242248|NCT01064362|B1|Baseline|Fondaparinux|All dosages of fondaparinux
242249|NCT01064362|P2|Participant Flow|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
242250|NCT01064362|P1|Participant Flow|Fondaparinux|All dosages of fondaparinux
242251|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
242252|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
242253|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
242254|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
243095|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
242258|NCT01064310|B2|Baseline|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242259|NCT01064310|B1|Baseline|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242260|NCT01064310|P2|Participant Flow|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242261|NCT01064310|P1|Participant Flow|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242262|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242263|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242264|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242265|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242266|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242267|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242268|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242269|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242270|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
243096|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
242271|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242272|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242273|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242274|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242275|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242276|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242277|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242278|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242279|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242280|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242281|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242282|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242328|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
243097|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
242283|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
242284|NCT01064310|E2|Reported Event|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242285|NCT01064310|E1|Reported Event|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
242286|NCT01064297|B4|Baseline|Total|Total of all reporting groups
242287|NCT01064297|B3|Baseline|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
242288|NCT01064297|B2|Baseline|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
242289|NCT01064297|B1|Baseline|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
242290|NCT01064297|P3|Participant Flow|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
242291|NCT01064297|P2|Participant Flow|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
242292|NCT01064297|P1|Participant Flow|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
242293|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
242294|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
242295|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
242296|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
242297|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
242298|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
242299|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
242300|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
242301|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
242302|NCT01064297|O3|Outcome|Dose Higher Than Prescribed|>400 mg/day maximal dose in first trimester
242303|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
242304|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
242305|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
242306|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
242307|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242308|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242309|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
242310|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
242311|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
242312|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242313|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242314|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
242315|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
242316|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
242317|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242318|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242319|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
242320|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
242321|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242322|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242323|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
242324|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
242325|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242326|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242327|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
249297|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
242329|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
242330|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
242331|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
242332|NCT01064297|E3|Reported Event|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
242333|NCT01064297|E2|Reported Event|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
242334|NCT01064297|E1|Reported Event|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
242335|NCT01064167|B3|Baseline|Total|Total of all reporting groups
242336|NCT01064167|B2|Baseline|Control Group|The placebo consisted of an equivalent volume of saline solution.
242337|NCT01064167|B1|Baseline|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
242338|NCT01064167|P2|Participant Flow|Control Group|The placebo consisted of an equivalent volume of saline solution.
242339|NCT01064167|P1|Participant Flow|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
242340|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
242341|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
242342|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
242343|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
242344|NCT01064167|E2|Reported Event|Control Group|The placebo consisted of an equivalent volume of saline solution.
242345|NCT01064167|E1|Reported Event|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
242346|NCT01063907|B1|Baseline|KW-2478 and Bortezomib|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2)."
242347|NCT01063907|P2|Participant Flow|Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2)."
242348|NCT01063907|P1|Participant Flow|Phase 1: KW-2478 and Bortezomib|"The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts."
242349|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242350|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242351|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242352|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242353|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242354|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242355|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242356|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242357|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242716|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242358|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242359|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242360|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242361|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242362|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242363|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242364|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
242365|NCT01063907|O6|Outcome|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
242366|NCT01063907|O5|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242367|NCT01063907|O4|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242368|NCT01063907|O3|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242369|NCT01063907|O2|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242370|NCT01063907|O1|Outcome|Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.~The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2)."
242371|NCT01063907|E6|Reported Event|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
242372|NCT01063907|E5|Reported Event|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242373|NCT01063907|E4|Reported Event|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242374|NCT01063907|E3|Reported Event|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242375|NCT01063907|E2|Reported Event|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
242376|NCT01063907|E1|Reported Event|Phase 1 and 2: KW-2478 and Bortezomib|KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
242377|NCT01063881|B4|Baseline|Total|Total of all reporting groups
242378|NCT01063881|B3|Baseline|Dapoxetine 30 to 60 to 30 mg|13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242379|NCT01063881|B2|Baseline|Dapoxetine 30 to 60 mg|124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242380|NCT01063881|B1|Baseline|Dapoxetine 30 mg Only|144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242381|NCT01063881|P3|Participant Flow|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242382|NCT01063881|P2|Participant Flow|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242383|NCT01063881|P1|Participant Flow|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242384|NCT01063881|O2|Outcome|Dapoxetine (Patients With IELT >1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242385|NCT01063881|O1|Outcome|Dapoxetine (Patients With IELT <1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242386|NCT01063881|O2|Outcome|Dapoxetine (Patients With Acquired PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242387|NCT01063881|O1|Outcome|Dapoxetine (Patients With Life-long PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242388|NCT01063881|O3|Outcome|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242389|NCT01063881|O2|Outcome|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242390|NCT01063881|O1|Outcome|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242391|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242392|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242393|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
242394|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242395|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
242396|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242397|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
242398|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242399|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
242400|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
242401|NCT01063881|E3|Reported Event|Depoxetine (DPX) 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242402|NCT01063881|E2|Reported Event|Depoxetine (DPX) 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242403|NCT01063881|E1|Reported Event|Depoxetine (DPX) 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
242404|NCT01063868|B3|Baseline|Total|Total of all reporting groups
242405|NCT01063868|B2|Baseline|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
242406|NCT01063868|B1|Baseline|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
242407|NCT01063868|P2|Participant Flow|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
242408|NCT01063868|P1|Participant Flow|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
242409|NCT01063868|O2|Outcome|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
242410|NCT01063868|O1|Outcome|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
242411|NCT01063868|E2|Reported Event|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
242412|NCT01063868|E1|Reported Event|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
242413|NCT01063855|B3|Baseline|Total|Total of all reporting groups
242414|NCT01063855|B2|Baseline|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242415|NCT01063855|B1|Baseline|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242624|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242416|NCT01063855|P2|Participant Flow|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242417|NCT01063855|P1|Participant Flow|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242418|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242419|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242420|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242421|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242422|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242423|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242424|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242425|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242426|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242427|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242428|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242429|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242430|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242431|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242432|NCT01063855|O4|Outcome|PDE5I + Dapoxetine (Week 12)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
242433|NCT01063855|O3|Outcome|PDE5I + Dapoxetine (Baseline)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
242434|NCT01063855|O2|Outcome|PDE5I + Placebo (Week 12)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242435|NCT01063855|O1|Outcome|PDE5I + Placebo (Baseline)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242436|NCT01063855|E2|Reported Event|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242437|NCT01063855|E1|Reported Event|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
242660|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
242661|NCT01062763|E2|Reported Event|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
242438|NCT01063764|B1|Baseline|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242439|NCT01063764|P1|Participant Flow|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242440|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242441|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242442|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242443|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242444|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242445|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242446|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242662|NCT01062763|E1|Reported Event|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
242663|NCT01062425|B3|Baseline|Total|Total of all reporting groups
242447|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242448|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242449|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242450|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242451|NCT01063764|E1|Reported Event|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
242452|NCT01063712|B1|Baseline|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
242453|NCT01063712|P1|Participant Flow|"Nit-Occlud® PDA-R Implantations Group"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
242454|NCT01063712|O1|Outcome|Number of Patients With Complete Regression of Dilation|"Children born with patent arterial duct develop cardiac insufficiency early in life. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the duct on time. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method.~This group of patients had 2-8 mm ductus, haven´t developed pulmonary hypertension and have enough weight to be treated.~Patients with left to right shunt show a dilation of left ventricle and left atrium. The quotient Left atrium/aortic ring is a well known method to estimate the grade of the dilation of the left atrium. The M-Mode method, is useful to assessed the regression of the ventricle after the ducts is closed. These observations were made at the beginning of the study and after six months."
242455|NCT01063712|O1|Outcome|Closure in the Control Period|"The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."
242664|NCT01062425|B2|Baseline|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242456|NCT01063712|E1|Reported Event|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
242457|NCT01063595|B1|Baseline|All Participants|Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
242458|NCT01063595|P2|Participant Flow|Octaplas LG First, Then Octaplas SD|Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
242459|NCT01063595|P1|Participant Flow|Octaplas SD First, Then Octaplas LG|Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.
242460|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
242461|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
242462|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
242463|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
242464|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
242465|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
242466|NCT01063595|E2|Reported Event|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
242467|NCT01063595|E1|Reported Event|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
242468|NCT01063517|B3|Baseline|Total|Total of all reporting groups
242469|NCT01063517|B2|Baseline|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242470|NCT01063517|B1|Baseline|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242471|NCT01063517|P2|Participant Flow|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242472|NCT01063517|P1|Participant Flow|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242473|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242474|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242475|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242476|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242477|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242478|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242479|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242480|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242481|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242717|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242482|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242483|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242484|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242485|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242486|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242487|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242488|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242489|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242490|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242491|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242492|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242493|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242494|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242495|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242496|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242497|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242498|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242499|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242500|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242501|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242502|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
249298|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
242503|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242504|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242505|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
242506|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
242507|NCT01063517|E2|Reported Event|PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD|
242508|NCT01063517|E1|Reported Event|OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD|
242509|NCT01063348|B3|Baseline|Total|Total of all reporting groups
242510|NCT01063348|B2|Baseline|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
242511|NCT01063348|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
242512|NCT01063348|P2|Participant Flow|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
242513|NCT01063348|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
242514|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
242515|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
242516|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
242517|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
242518|NCT01063348|E2|Reported Event|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
242519|NCT01063348|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
242520|NCT01063153|B3|Baseline|Total|Total of all reporting groups
242521|NCT01063153|B2|Baseline|ADHD|Subjects with ADHD
242522|NCT01063153|B1|Baseline|Control|Subjects without ADHD
242523|NCT01063153|P2|Participant Flow|ADHD|Subjects with ADHD were assessed with EEG before and after treatment with Concerta
242524|NCT01063153|P1|Participant Flow|Control|Controls without ADHD were assessed using EEG
242525|NCT01063153|O2|Outcome|Controls|Controls without ADHD were assessed with a one-time EEG, only.
242526|NCT01063153|O1|Outcome|ADHD|Subjects with ADHD were assessed before and after treatment.
242527|NCT01063153|E2|Reported Event|ADHD|Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
242528|NCT01063153|E1|Reported Event|Control|Subjects without ADHD were assessed using EEG.
242529|NCT01063075|B1|Baseline|All Participants (Group A, B, C and D)|"Group D:~Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.~Group C:~Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.~Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.~Group B:~Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.~Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.~Group A:~Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.~400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1."
242530|NCT01063075|P4|Participant Flow|Cetuximab and Carboplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
242531|NCT01063075|P3|Participant Flow|Cetuximab and Carboplatin (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242532|NCT01063075|P2|Participant Flow|Cetuximab and Carboplatin (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
242533|NCT01063075|P1|Participant Flow|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
242534|NCT01063075|O1|Outcome|Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
242535|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242536|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242537|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
242538|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242539|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242540|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
242541|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242565|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242566|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242542|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242543|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
242544|NCT01063075|E4|Reported Event|Carboplatin and Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1."
242545|NCT01063075|E3|Reported Event|Carboplatin and Cetuximab (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
242546|NCT01063075|E2|Reported Event|Carboplatin and Cetuximab (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
242547|NCT01063075|E1|Reported Event|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
242548|NCT01063062|B3|Baseline|Total|Total of all reporting groups
242549|NCT01063062|B2|Baseline|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242550|NCT01063062|B1|Baseline|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242551|NCT01063062|P2|Participant Flow|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242552|NCT01063062|P1|Participant Flow|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242553|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242554|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242555|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242556|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242557|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242558|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242559|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242560|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242561|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242562|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242563|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242564|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242567|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242568|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242569|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242570|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242571|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242572|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242573|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242574|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242575|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242576|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242577|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242578|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242579|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242580|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242581|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242582|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242583|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242584|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242585|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242586|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242587|NCT01063062|E2|Reported Event|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
242588|NCT01063062|E1|Reported Event|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
242589|NCT01063049|B4|Baseline|Total|Total of all reporting groups
242590|NCT01063049|B3|Baseline|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242591|NCT01063049|B2|Baseline|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242592|NCT01063049|B1|Baseline|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
242593|NCT01063049|P3|Participant Flow|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242594|NCT01063049|P2|Participant Flow|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242595|NCT01063049|P1|Participant Flow|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
242596|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242597|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242598|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
242599|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242600|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242601|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
242602|NCT01063049|E3|Reported Event|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242603|NCT01063049|E2|Reported Event|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
242604|NCT01063049|E1|Reported Event|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
242605|NCT01063036|B1|Baseline|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242606|NCT01063036|P1|Participant Flow|Entecavir + Tenofovir|"Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242607|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242608|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242609|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242610|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242611|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242612|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242613|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242614|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242615|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242616|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242617|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
242618|NCT01063036|E1|Reported Event|Entecavir + Tenofovir|Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
242619|NCT01062841|B3|Baseline|Total|Total of all reporting groups
242620|NCT01062841|B2|Baseline|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242621|NCT01062841|B1|Baseline|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242622|NCT01062841|P2|Participant Flow|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only.
242623|NCT01062841|P1|Participant Flow|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) monthly using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242713|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242625|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242626|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242627|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242628|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242629|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242630|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242631|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242632|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242633|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242634|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242635|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242636|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242637|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242638|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242714|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242715|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
242639|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242640|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242641|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242642|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242643|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242644|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242645|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242646|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242647|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242648|NCT01062841|E2|Reported Event|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
242649|NCT01062841|E1|Reported Event|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
242650|NCT01062763|B3|Baseline|Total|Total of all reporting groups
242651|NCT01062763|B2|Baseline|Placebo|
242652|NCT01062763|B1|Baseline|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
242653|NCT01062763|P2|Participant Flow|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
242654|NCT01062763|P1|Participant Flow|Placebo|1tablet of matching placebo trated up to 2 if neccessary
242655|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
242656|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
242657|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
242658|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
242659|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
242665|NCT01062425|B1|Baseline|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242666|NCT01062425|P2|Participant Flow|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242667|NCT01062425|P1|Participant Flow|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242668|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242669|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242670|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242671|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242672|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242673|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242674|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242675|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242676|NCT01062425|E2|Reported Event|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
242677|NCT01062425|E1|Reported Event|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
242678|NCT01062308|B3|Baseline|Total|Total of all reporting groups
242679|NCT01062308|B2|Baseline|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
242680|NCT01062308|B1|Baseline|Taping|Procedure for preventing shoulder injury
242681|NCT01062308|P2|Participant Flow|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
242682|NCT01062308|P1|Participant Flow|Taping|Procedure for preventing shoulder injury
242683|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
242684|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
242685|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
242686|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
242687|NCT01062308|E2|Reported Event|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
242688|NCT01062308|E1|Reported Event|Taping|Procedure for preventing shoulder injury
242689|NCT01062269|B1|Baseline|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
242690|NCT01062269|P1|Participant Flow|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
242691|NCT01062269|O3|Outcome|Tang|
242692|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
242693|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
242694|NCT01062269|O3|Outcome|Tang|
242695|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
242696|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
242697|NCT01062269|E3|Reported Event|Tang|
242698|NCT01062269|E2|Reported Event|Cholestyramine 12 Grams|
242699|NCT01062269|E1|Reported Event|Cholestyramine 4 Grams|
242700|NCT01062256|B4|Baseline|Total|Total of all reporting groups
242701|NCT01062256|B3|Baseline|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242702|NCT01062256|B2|Baseline|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242703|NCT01062256|B1|Baseline|Placebo|One placebo tablet administered orally as a single dose
242704|NCT01062256|P3|Participant Flow|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242705|NCT01062256|P2|Participant Flow|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242706|NCT01062256|P1|Participant Flow|Placebo|One placebo tablet administered orally as a single dose
242707|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242708|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242709|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
242710|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242711|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242712|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
242719|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242720|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242721|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
242722|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242723|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242724|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
242725|NCT01062256|E3|Reported Event|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
242726|NCT01062256|E2|Reported Event|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
242727|NCT01062256|E1|Reported Event|Placebo|One placebo tablet administered orally as a single dose
242728|NCT01062230|B1|Baseline|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
242729|NCT01062230|P1|Participant Flow|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
242730|NCT01062230|O1|Outcome|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
242731|NCT01062230|E1|Reported Event|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
242732|NCT01062165|B1|Baseline|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
242733|NCT01062165|P1|Participant Flow|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
242734|NCT01062165|O1|Outcome|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
242735|NCT01062165|E1|Reported Event|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
242736|NCT01062113|B4|Baseline|Total|Total of all reporting groups
242737|NCT01062113|B3|Baseline|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242738|NCT01062113|B2|Baseline|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242739|NCT01062113|B1|Baseline|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
242740|NCT01062113|P3|Participant Flow|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242741|NCT01062113|P2|Participant Flow|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242742|NCT01062113|P1|Participant Flow|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
242743|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242744|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242745|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242746|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242747|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242748|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200mg|Included participants who received Celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242749|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242750|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242751|NCT01062113|E3|Reported Event|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242752|NCT01062113|E2|Reported Event|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
242753|NCT01062113|E1|Reported Event|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
242754|NCT01062074|B1|Baseline|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
242755|NCT01062074|P1|Participant Flow|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
242756|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
242757|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
242758|NCT01062074|E1|Reported Event|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
242759|NCT01062061|B1|Baseline|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242760|NCT01062061|P1|Participant Flow|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242761|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242762|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242763|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242764|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242765|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242766|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242767|NCT01062061|O2|Outcome|Age ≥2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242768|NCT01062061|O1|Outcome|Age <2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242769|NCT01062061|O2|Outcome|Female Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242770|NCT01062061|O1|Outcome|Male Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242771|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242772|NCT01062061|E1|Reported Event|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
242773|NCT01061866|B1|Baseline|Thalidomide|Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.
242774|NCT01061866|P1|Participant Flow|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
242775|NCT01061866|O1|Outcome|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
242776|NCT01061866|E1|Reported Event|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
242777|NCT01061775|B1|Baseline|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
242778|NCT01061775|P1|Participant Flow|Exenatide|Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
242779|NCT01061775|O1|Outcome|Exenatide|"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.~Of 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."
242780|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
242781|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
242782|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
242783|NCT01061775|E1|Reported Event|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
242784|NCT01061710|B1|Baseline|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242785|NCT01061710|P1|Participant Flow|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242786|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242862|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
243098|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
242787|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242788|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242789|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242790|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242791|NCT01061710|E1|Reported Event|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
242792|NCT01061671|B3|Baseline|Total|Total of all reporting groups
242793|NCT01061671|B2|Baseline|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242794|NCT01061671|B1|Baseline|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242795|NCT01061671|P2|Participant Flow|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242796|NCT01061671|P1|Participant Flow|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242797|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242798|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242799|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242800|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242801|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242802|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242803|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242804|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242805|NCT01061671|E2|Reported Event|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
242806|NCT01061671|E1|Reported Event|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
242807|NCT01061606|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242808|NCT01061606|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242809|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242810|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242811|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242812|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242813|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242814|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242815|NCT01061606|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
242816|NCT01061567|B1|Baseline|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242817|NCT01061567|P1|Participant Flow|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242818|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242819|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242820|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242821|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242822|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242823|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242824|NCT01061567|E1|Reported Event|All Patients|Patients with Parkinson’s disease in routine clinical practice.
242825|NCT01061476|B1|Baseline|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
242826|NCT01061476|P1|Participant Flow|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
242827|NCT01061476|O1|Outcome|Single Arm - Sleep Apnea|"Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep.~Participants did not use Provent™ outside of the sleep laboratory.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
242828|NCT01061476|E1|Reported Event|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
242829|NCT01061385|B3|Baseline|Total|Total of all reporting groups
242830|NCT01061385|B2|Baseline|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
242831|NCT01061385|B1|Baseline|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
242832|NCT01061385|P2|Participant Flow|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
242833|NCT01061385|P1|Participant Flow|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
242834|NCT01061385|O2|Outcome|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
242835|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
242836|NCT01061385|O2|Outcome|Control|Control subjects receiving diet and exercise counseling only
242837|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
242838|NCT01061385|E2|Reported Event|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
242839|NCT01061385|E1|Reported Event|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
242840|NCT01061359|B1|Baseline|Entire Study Population|Includes all groups enrolled in the study
242841|NCT01061359|P1|Participant Flow|Entire Study Population|Includes all groups enrolled in the study
242842|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
242843|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
242844|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
242845|NCT01061359|E1|Reported Event|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
242846|NCT01061333|B1|Baseline|All Participants|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
242847|NCT01061333|P2|Participant Flow|Placebo-Nedocromil-Montelukast-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
242848|NCT01061333|P1|Participant Flow|Placebo-Montelukast-Nedocromil-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
242849|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242850|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242851|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242852|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242853|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242854|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242855|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242856|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242857|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242858|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242859|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242860|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242861|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242863|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242864|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242865|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242866|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242867|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242868|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242869|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242870|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242871|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242872|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242873|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242874|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242875|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242876|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler
242877|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242878|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242879|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242880|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242881|NCT01061333|E4|Reported Event|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
242882|NCT01061333|E3|Reported Event|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
242883|NCT01061333|E2|Reported Event|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
242884|NCT01061333|E1|Reported Event|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
242885|NCT01061034|B1|Baseline|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
242886|NCT01061034|P1|Participant Flow|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
242887|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
242888|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
242889|NCT01061034|E1|Reported Event|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
242890|NCT01061008|B3|Baseline|Total|Total of all reporting groups
242891|NCT01061008|B2|Baseline|Treatment as Usual|
242892|NCT01061008|B1|Baseline|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
242893|NCT01061008|P2|Participant Flow|Treatment as Usual|
242894|NCT01061008|P1|Participant Flow|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
242895|NCT01061008|O2|Outcome|Treatment as Usual|
242896|NCT01061008|O1|Outcome|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
242897|NCT01061008|E2|Reported Event|Treatment as Usual|
242898|NCT01061008|E1|Reported Event|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
242899|NCT01060670|B3|Baseline|Total|Total of all reporting groups
242900|NCT01060670|B2|Baseline|Control Treatment|Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
242901|NCT01060670|B1|Baseline|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
242902|NCT01060670|P2|Participant Flow|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242903|NCT01060670|P1|Participant Flow|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242904|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242905|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242906|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242907|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242908|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242909|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242910|NCT01060670|O2|Outcome|Moist Wound Therapy|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242911|NCT01060670|O1|Outcome|Dermal Replacement Device|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242912|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242913|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242914|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242915|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242916|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242917|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242918|NCT01060670|E2|Reported Event|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
242919|NCT01060670|E1|Reported Event|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
242920|NCT01060592|B3|Baseline|Total|Total of all reporting groups
242921|NCT01060592|B2|Baseline|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242922|NCT01060592|B1|Baseline|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242923|NCT01060592|P2|Participant Flow|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242924|NCT01060592|P1|Participant Flow|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242925|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242926|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242927|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242928|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242929|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242930|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242931|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242932|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242933|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
242934|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242935|NCT01060592|E2|Reported Event|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
243086|NCT01059994|B5|Baseline|Total|Total of all reporting groups
242936|NCT01060592|E1|Reported Event|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
242937|NCT01060553|B1|Baseline|Arm 1|24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
242938|NCT01060553|P2|Participant Flow|Wait List Control|this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
242939|NCT01060553|P1|Participant Flow|Active Treatment|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
242940|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
242941|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment"
242942|NCT01060553|E1|Reported Event|Arm 1|The treatment program will consist of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
242943|NCT01060540|B3|Baseline|Total|Total of all reporting groups
242944|NCT01060540|B2|Baseline|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
242945|NCT01060540|B1|Baseline|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
242946|NCT01060540|P2|Participant Flow|CR+EYE|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~eye disease counseling"
242947|NCT01060540|P1|Participant Flow|CR+G|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11"
242948|NCT01060540|O2|Outcome|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
242949|NCT01060540|O1|Outcome|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
242950|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
242951|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
242952|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
242953|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
242954|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
243087|NCT01059994|B4|Baseline|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
242955|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
242956|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
242957|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
242958|NCT01060540|E2|Reported Event|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
242959|NCT01060540|E1|Reported Event|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
242960|NCT01060150|B1|Baseline|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242961|NCT01060150|P1|Participant Flow|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242962|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242963|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242964|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242965|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242966|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242967|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242968|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242969|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242970|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242971|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242972|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
243088|NCT01059994|B3|Baseline|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
243089|NCT01059994|B2|Baseline|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
242973|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242974|NCT01060150|E1|Reported Event|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
242975|NCT01060124|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242976|NCT01060124|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242977|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242978|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242979|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242980|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242981|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242982|NCT01060124|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
242983|NCT01060111|B4|Baseline|Total|Total of all reporting groups
242984|NCT01060111|B3|Baseline|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
242985|NCT01060111|B2|Baseline|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
242986|NCT01060111|B1|Baseline|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
242987|NCT01060111|P3|Participant Flow|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
242988|NCT01060111|P2|Participant Flow|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
242989|NCT01060111|P1|Participant Flow|Topiramate Standard|Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
242990|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
242991|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242992|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242993|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
242994|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242995|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242996|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
242997|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242998|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
242999|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
243000|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
243001|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
243002|NCT01060111|E3|Reported Event|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
243003|NCT01060111|E2|Reported Event|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
243004|NCT01060111|E1|Reported Event|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
243005|NCT01060072|B3|Baseline|Total|Total of all reporting groups
243006|NCT01060072|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243007|NCT01060072|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243008|NCT01060072|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243009|NCT01060072|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243010|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243011|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243012|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243013|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243014|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243015|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243016|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243017|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243018|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243019|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243020|NCT01060072|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
243021|NCT01060072|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
243022|NCT01060059|B3|Baseline|Total|Total of all reporting groups
243023|NCT01060059|B2|Baseline|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243024|NCT01060059|B1|Baseline|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243025|NCT01060059|P2|Participant Flow|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243026|NCT01060059|P1|Participant Flow|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243027|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243028|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
249299|NCT01037244|O4|Outcome|Placebo|Placebo tablets
243029|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243030|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243031|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243032|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243033|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243034|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243035|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243036|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243037|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243038|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243039|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
243040|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
243041|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243042|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243043|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243044|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243045|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243046|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243047|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243048|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243049|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243090|NCT01059994|B1|Baseline|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
243050|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243051|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243052|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243053|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243054|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243055|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243056|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243057|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243058|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243059|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243060|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243061|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243062|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243063|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243064|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243065|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243066|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243067|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243068|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243069|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243070|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243091|NCT01059994|P4|Participant Flow|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
243071|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243072|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243073|NCT01060059|E2|Reported Event|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
243074|NCT01060059|E1|Reported Event|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
243075|NCT01060007|B1|Baseline|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243076|NCT01060007|P1|Participant Flow|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243077|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243078|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243079|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243080|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243081|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243082|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243083|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243084|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243085|NCT01060007|E1|Reported Event|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
243099|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
243100|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
243101|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
243102|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
243103|NCT01059994|E4|Reported Event|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
243104|NCT01059994|E3|Reported Event|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
243105|NCT01059994|E2|Reported Event|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
243106|NCT01059994|E1|Reported Event|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
243107|NCT01059903|B3|Baseline|Total|Total of all reporting groups
243108|NCT01059903|B2|Baseline|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
243109|NCT01059903|B1|Baseline|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
243110|NCT01059903|P2|Participant Flow|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
243111|NCT01059903|P1|Participant Flow|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
243112|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243113|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243114|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243115|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243116|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243117|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243118|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243119|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243120|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243121|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243122|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243123|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243124|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243125|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243126|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243127|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243128|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243129|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243130|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243131|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243132|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243133|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243134|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243135|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243136|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243137|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243138|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243139|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243140|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243141|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243142|NCT01059903|E2|Reported Event|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
243143|NCT01059903|E1|Reported Event|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
243144|NCT01059864|B1|Baseline|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
243145|NCT01059864|P3|Participant Flow|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243146|NCT01059864|P2|Participant Flow|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243147|NCT01059864|P1|Participant Flow|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
243148|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243149|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243150|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243151|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243152|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243153|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243154|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243155|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243156|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243157|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243158|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243159|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243160|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243161|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243162|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243163|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243164|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
244084|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
243165|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243166|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243167|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243168|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243169|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243170|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243171|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243172|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243173|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243174|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243175|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243176|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243177|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243178|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243179|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243180|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243181|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243182|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243183|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243184|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243185|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243217|NCT01059812|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243186|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243187|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243188|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243189|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243190|NCT01059864|E3|Reported Event|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243191|NCT01059864|E2|Reported Event|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
243192|NCT01059864|E1|Reported Event|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
243193|NCT01059851|B3|Baseline|Total|Total of all reporting groups
243194|NCT01059851|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243195|NCT01059851|B1|Baseline|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243196|NCT01059851|P6|Participant Flow|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243197|NCT01059851|P5|Participant Flow|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243198|NCT01059851|P4|Participant Flow|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243199|NCT01059851|P3|Participant Flow|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243200|NCT01059851|P2|Participant Flow|Healthy Participants (Severe Impairment Controls) (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243201|NCT01059851|P1|Participant Flow|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243202|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243203|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243204|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243205|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243206|NCT01059851|O4|Outcome|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243207|NCT01059851|O3|Outcome|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243208|NCT01059851|O2|Outcome|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243209|NCT01059851|O1|Outcome|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
243210|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243211|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243212|NCT01059851|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
243213|NCT01059851|E1|Reported Event|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
243214|NCT01059812|B3|Baseline|Total|Total of all reporting groups
243215|NCT01059812|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243216|NCT01059812|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243218|NCT01059812|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243219|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243220|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243221|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243222|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243223|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243224|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243225|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243226|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243227|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243228|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243229|NCT01059812|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243230|NCT01059812|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
243231|NCT01059799|B3|Baseline|Total|Total of all reporting groups
243232|NCT01059799|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243233|NCT01059799|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243234|NCT01059799|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243235|NCT01059799|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243236|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243237|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243238|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243239|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243240|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243241|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243242|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243243|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243244|NCT01059799|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243245|NCT01059799|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
243246|NCT01059773|B3|Baseline|Total|Total of all reporting groups
243247|NCT01059773|B2|Baseline|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243248|NCT01059773|B1|Baseline|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243249|NCT01059773|P2|Participant Flow|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243250|NCT01059773|P1|Participant Flow|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243251|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
243252|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
243253|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
243254|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
243255|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
243256|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
243257|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
243258|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
243259|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
243260|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243261|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243262|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243263|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
243264|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243265|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243266|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243267|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
243268|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
243269|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
243270|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243271|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243272|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243273|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
243274|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243275|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243276|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243277|NCT01059773|E2|Reported Event|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
243315|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243278|NCT01059773|E1|Reported Event|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
243279|NCT01059630|B3|Baseline|Total|Total of all reporting groups
243280|NCT01059630|B2|Baseline|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243281|NCT01059630|B1|Baseline|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243282|NCT01059630|P2|Participant Flow|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with complete response (CR), partial response (PR) or stable disease (SD) then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243283|NCT01059630|P1|Participant Flow|Bendamustine Alone|Participants received Bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243284|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243285|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243286|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243287|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243288|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243289|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243290|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243291|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243292|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243293|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243294|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243295|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243296|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
244085|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
243297|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243298|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243299|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243300|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243301|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243302|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243303|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243304|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243305|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243306|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243307|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243308|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243309|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243310|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243311|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243312|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243313|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243314|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
244086|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
243316|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243317|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243318|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243319|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243320|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243321|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243322|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243323|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243324|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243325|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243326|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243327|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243328|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243329|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243330|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243331|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243332|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243333|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243358|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243540|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243334|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243335|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243336|NCT01059630|E2|Reported Event|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
243337|NCT01059630|E1|Reported Event|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
243338|NCT01059617|B5|Baseline|Total|Total of all reporting groups
243339|NCT01059617|B4|Baseline|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243340|NCT01059617|B3|Baseline|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243341|NCT01059617|B2|Baseline|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243342|NCT01059617|B1|Baseline|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243343|NCT01059617|P4|Participant Flow|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243344|NCT01059617|P3|Participant Flow|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243345|NCT01059617|P2|Participant Flow|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243346|NCT01059617|P1|Participant Flow|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243347|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243348|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243349|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243350|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243351|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243352|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243353|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243354|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243355|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243356|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243357|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243688|NCT01057888|E1|Reported Event|Mailed Reminders and Letter Reminders|
243359|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243360|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243361|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243362|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243363|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243364|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243365|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243366|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243367|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243368|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243369|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243370|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243371|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243372|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243373|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243374|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243375|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243376|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243377|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243378|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243379|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243380|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243381|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243382|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243383|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243384|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243538|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243689|NCT01057810|B3|Baseline|Total|Total of all reporting groups
243385|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243386|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243387|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243388|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243389|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243390|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243391|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243392|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243393|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243394|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243395|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243396|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243397|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243398|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243399|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243400|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243401|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243402|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243403|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243404|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243405|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243406|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243407|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243408|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243409|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243410|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243411|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243412|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243413|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243414|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243415|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243416|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243417|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243418|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243419|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243420|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243421|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243422|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243423|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243424|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243425|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243426|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243427|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243428|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243429|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243430|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243431|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243432|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243433|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243434|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243435|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243436|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243437|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243438|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243439|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243440|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243441|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243442|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243443|NCT01059617|O6|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243444|NCT01059617|O5|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243445|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243446|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243447|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243448|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243449|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243450|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243451|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243452|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243453|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243454|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243455|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243456|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243457|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243458|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243539|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
244087|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
243459|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243460|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243461|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243462|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243463|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243464|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243465|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243466|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243467|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243468|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243469|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243470|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243471|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243472|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243473|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243474|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243475|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243476|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243477|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243478|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243479|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243480|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243481|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243482|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243483|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243484|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243485|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243486|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243487|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243488|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243489|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243490|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243491|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243492|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243493|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243494|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243495|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243496|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243497|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243498|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243499|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243500|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243501|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243502|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243503|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243504|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243505|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243506|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243507|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243508|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243509|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243510|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243511|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243512|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243513|NCT01059617|E6|Reported Event|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
243514|NCT01059617|E5|Reported Event|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
243515|NCT01059617|E4|Reported Event|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243516|NCT01059617|E3|Reported Event|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243517|NCT01059617|E2|Reported Event|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243518|NCT01059617|E1|Reported Event|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
243519|NCT01059565|B3|Baseline|Total|Total of all reporting groups
243520|NCT01059565|B2|Baseline|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243521|NCT01059565|B1|Baseline|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243522|NCT01059565|P2|Participant Flow|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
243523|NCT01059565|P1|Participant Flow|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
243524|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243525|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243526|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243527|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243528|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243529|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243530|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243531|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243532|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243533|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243534|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243535|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243536|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243537|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
249300|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
243541|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243542|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243543|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243544|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243545|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243546|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243547|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243548|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243549|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243550|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243551|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
243552|NCT01059565|E4|Reported Event|Placebo/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
243553|NCT01059565|E3|Reported Event|AZLI/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
243554|NCT01059565|E2|Reported Event|Placebo|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
243555|NCT01059565|E1|Reported Event|AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
243556|NCT01059526|B3|Baseline|Total|Total of all reporting groups
243557|NCT01059526|B2|Baseline|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
243558|NCT01059526|B1|Baseline|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
243559|NCT01059526|P2|Participant Flow|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
243560|NCT01059526|P1|Participant Flow|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
243561|NCT01059526|O2|Outcome|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
243562|NCT01059526|O1|Outcome|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
243563|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
243564|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
243565|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
243566|NCT01059526|E1|Reported Event|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
243567|NCT01059071|B1|Baseline|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243568|NCT01059071|P4|Participant Flow|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243569|NCT01059071|P3|Participant Flow|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243570|NCT01059071|P2|Participant Flow|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243571|NCT01059071|P1|Participant Flow|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243572|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243573|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243574|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243575|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243576|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243577|NCT01059071|O4|Outcome|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243578|NCT01059071|O3|Outcome|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243579|NCT01059071|O2|Outcome|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243580|NCT01059071|O1|Outcome|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243581|NCT01059071|E1|Reported Event|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
243582|NCT01058993|B1|Baseline|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
243583|NCT01058993|P1|Participant Flow|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
243584|NCT01058993|O1|Outcome|SINGLE Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
243585|NCT01058993|E1|Reported Event|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
243586|NCT01058863|B1|Baseline|Randomized Treated Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
243587|NCT01058863|P1|Participant Flow|All Randomized Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
243588|NCT01058863|O1|Outcome|All Randomized Participants|Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
243589|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243590|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243591|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243592|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243593|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
243594|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243595|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243596|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243597|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243598|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
243599|NCT01058863|E5|Reported Event|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243600|NCT01058863|E4|Reported Event|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243601|NCT01058863|E3|Reported Event|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
243602|NCT01058863|E2|Reported Event|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
243603|NCT01058863|E1|Reported Event|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
243604|NCT01058642|B5|Baseline|Total|Total of all reporting groups
243605|NCT01058642|B4|Baseline|Treatment Sequence 4: ADL5747 Then Placebo|"ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.~Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
243606|NCT01058642|B3|Baseline|Treatment Sequence 3: Placebo Then ADL5747|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods."
243607|NCT01058642|B2|Baseline|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.~Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
243608|NCT01058642|B1|Baseline|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period."
243609|NCT01058642|P4|Participant Flow|Treatment Sequence 4: ADL5747 Then Placebo|"During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
243774|NCT01057277|B1|Baseline|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
243610|NCT01058642|P3|Participant Flow|Treatment Sequence 3: Placebo Then ADL5747|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week"
243611|NCT01058642|P2|Participant Flow|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).~At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
243612|NCT01058642|P1|Participant Flow|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days."
243613|NCT01058642|O3|Outcome|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
243614|NCT01058642|O2|Outcome|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
243615|NCT01058642|O1|Outcome|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
243616|NCT01058642|E3|Reported Event|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
243617|NCT01058642|E2|Reported Event|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
243618|NCT01058642|E1|Reported Event|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
243619|NCT01058356|B1|Baseline|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
243620|NCT01058356|P1|Participant Flow|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
243621|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
243622|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
243623|NCT01058356|E1|Reported Event|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
243624|NCT01058304|B3|Baseline|Total|Total of all reporting groups
243625|NCT01058304|B2|Baseline|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
243626|NCT01058304|B1|Baseline|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
243708|NCT01057693|B1|Baseline|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243627|NCT01058304|P2|Participant Flow|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
243628|NCT01058304|P1|Participant Flow|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
243629|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
243630|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
243631|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
243632|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
243633|NCT01058304|E2|Reported Event|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
243634|NCT01058304|E1|Reported Event|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
243635|NCT01058265|B3|Baseline|Total|Total of all reporting groups
243636|NCT01058265|B2|Baseline|Standard|Standard general medical evaluation.
243637|NCT01058265|B1|Baseline|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
243638|NCT01058265|P2|Participant Flow|Standard|Standard general medical evaluation.
243639|NCT01058265|P1|Participant Flow|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
243640|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
243641|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
243642|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
243643|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
243644|NCT01058265|E2|Reported Event|Standard|Standard general medical evaluation.
243645|NCT01058265|E1|Reported Event|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
243646|NCT01058070|B1|Baseline|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
243647|NCT01058070|P1|Participant Flow|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
243648|NCT01058070|O1|Outcome|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
243649|NCT01058070|O1|Outcome|LINX Study Subjects|Subjects implanted with LINX device
243650|NCT01058070|E1|Reported Event|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
243651|NCT01058005|B4|Baseline|Total|Total of all reporting groups
243652|NCT01058005|B3|Baseline|Glatiramer Acetate|20 mg subcutaneous injection once daily
243653|NCT01058005|B2|Baseline|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
243654|NCT01058005|B1|Baseline|Natalizumab|300 mg intravenous injection every 4 weeks
243655|NCT01058005|P3|Participant Flow|Glatiramer Acetate|20 mg subcutaneous injection once daily
243656|NCT01058005|P2|Participant Flow|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
243657|NCT01058005|P1|Participant Flow|Natalizumab|300 mg intravenous injection every 4 weeks
243658|NCT01058005|O3|Outcome|Glatiramer Acetate|20 mg subcutaneous injection once daily
243659|NCT01058005|O2|Outcome|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
243660|NCT01058005|O1|Outcome|Natalizumab|300 mg intravenous injection every 4 weeks
243661|NCT01058005|E3|Reported Event|Glatiramer Acetate|20 mg subcutaneous injection once daily
243662|NCT01058005|E2|Reported Event|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
243663|NCT01058005|E1|Reported Event|Natalizumab|300 mg intravenous injection every 4 weeks
243664|NCT01057901|B3|Baseline|Total|Total of all reporting groups
243665|NCT01057901|B2|Baseline|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
243666|NCT01057901|B1|Baseline|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
243667|NCT01057901|P2|Participant Flow|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
243668|NCT01057901|P1|Participant Flow|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
243669|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
243670|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
243671|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
243672|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
243673|NCT01057901|E2|Reported Event|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
243674|NCT01057901|E1|Reported Event|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
243675|NCT01057888|B4|Baseline|Total|Total of all reporting groups
243676|NCT01057888|B3|Baseline|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
243677|NCT01057888|B2|Baseline|Controls|"Controls~Received standard of care provided by practice"
243678|NCT01057888|B1|Baseline|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
243679|NCT01057888|P3|Participant Flow|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
243680|NCT01057888|P2|Participant Flow|Controls|"Controls~Received standard of care provided by practice"
243681|NCT01057888|P1|Participant Flow|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
243682|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
243683|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
243684|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
243685|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
243686|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
243687|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
243690|NCT01057810|B2|Baseline|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243691|NCT01057810|B1|Baseline|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243692|NCT01057810|P2|Participant Flow|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243693|NCT01057810|P1|Participant Flow|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243694|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243695|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243696|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243697|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243698|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243699|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243700|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243701|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243702|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243703|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243704|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243705|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243706|NCT01057810|E2|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243707|NCT01057810|E1|Reported Event|PLACEBO|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
243709|NCT01057693|P3|Participant Flow|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243710|NCT01057693|P2|Participant Flow|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243711|NCT01057693|P1|Participant Flow|Pregabalin SB|Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
243712|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243713|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243714|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243715|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243716|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243717|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243718|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243719|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243720|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243721|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243722|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243723|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243724|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243725|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243726|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243727|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243728|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243729|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243730|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243731|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243732|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243733|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243773|NCT01057394|E1|Reported Event|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
243734|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243735|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243736|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243737|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243738|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243739|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243740|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243741|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243742|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243743|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243744|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243745|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243746|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243747|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243748|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243749|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243750|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243751|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243752|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243753|NCT01057693|E3|Reported Event|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
243754|NCT01057693|E2|Reported Event|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
243755|NCT01057693|E1|Reported Event|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
243756|NCT01057589|B1|Baseline|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
244088|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
243757|NCT01057589|P1|Participant Flow|Pemetrexed + Cisplatin + Cetuximab|"Pemetrexed 500 milligram per meter squared (mg/m^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles.~At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.~Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements."
243758|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243759|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243760|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243761|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243762|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243763|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243764|NCT01057589|E1|Reported Event|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
243765|NCT01057433|B1|Baseline|All Subjects|
243766|NCT01057433|P1|Participant Flow|All Subjects|
243767|NCT01057433|O1|Outcome|All Subjects|
243768|NCT01057433|E1|Reported Event|All Subjects|
243769|NCT01057394|B1|Baseline|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
243770|NCT01057394|P2|Participant Flow|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
243771|NCT01057394|P1|Participant Flow|Radiofrequency Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
243772|NCT01057394|O1|Outcome|Number of Chronically Isolated Pulmonary Veins|
243775|NCT01057277|P1|Participant Flow|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
243776|NCT01057277|O1|Outcome|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
243777|NCT01057277|E1|Reported Event|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
243778|NCT01057251|B3|Baseline|Total|Total of all reporting groups
243779|NCT01057251|B2|Baseline|Placebo|Dose-matched placebo, once daily oral administration
243780|NCT01057251|B1|Baseline|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
243781|NCT01057251|P2|Participant Flow|Placebo|Dose-matched placebo, once daily oral administration
243782|NCT01057251|P1|Participant Flow|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
243783|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
243784|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
243785|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
243786|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
243787|NCT01057251|E2|Reported Event|Placebo|Dose-matched placebo, once daily oral administration
243788|NCT01057251|E1|Reported Event|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
243789|NCT01057225|B1|Baseline|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243790|NCT01057225|P6|Participant Flow|Phase II: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243791|NCT01057225|P5|Participant Flow|Phase II: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243792|NCT01057225|P4|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243793|NCT01057225|P3|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243794|NCT01057225|P2|Participant Flow|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243795|NCT01057225|P1|Participant Flow|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243796|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243797|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243798|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243799|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243800|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243801|NCT01057225|O4|Outcome|Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243802|NCT01057225|O3|Outcome|Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243803|NCT01057225|O2|Outcome|Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243804|NCT01057225|O1|Outcome|Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243805|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
249301|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
243806|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243807|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243808|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243809|NCT01057225|O4|Outcome|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243810|NCT01057225|O3|Outcome|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243811|NCT01057225|O2|Outcome|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243812|NCT01057225|O1|Outcome|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
243813|NCT01057225|E1|Reported Event|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
243814|NCT01057121|B3|Baseline|Total|Total of all reporting groups
243815|NCT01057121|B2|Baseline|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243816|NCT01057121|B1|Baseline|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243817|NCT01057121|P5|Participant Flow|Phase II: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
243818|NCT01057121|P4|Participant Flow|Phase I: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
243819|NCT01057121|P3|Participant Flow|Phase I, Treatment Ienalidomide), 20 mg/Day|Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
243820|NCT01057121|P2|Participant Flow|Phase I: Treatment (Lenalidomide), 15 mg/Day|Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
243821|NCT01057121|P1|Participant Flow|Phase I: Treatment (Lenalidomide) , 10 mg/Day|Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
243822|NCT01057121|O2|Outcome|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243823|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243824|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243825|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243826|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243827|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243828|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
249302|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
243829|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243830|NCT01057121|O4|Outcome|Phase I: Treatment (Lenalidomide), 25 mg/Day|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243831|NCT01057121|O3|Outcome|Phase I - 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243832|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243833|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243834|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243835|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243836|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243837|NCT01057121|O2|Outcome|Phase I - 15 mg/Day Lenalidomide|"Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243838|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Lenalidomide|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243839|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243840|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243841|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243842|NCT01057121|O2|Outcome|Phase I - 15 mg/Day (Lenalidomide)|"Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243843|NCT01057121|O1|Outcome|Phase I - 10 mg/Day (Lenalidomide)|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243844|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)"
243845|NCT01057121|E4|Reported Event|Phase I and II: 25 mg/Day Lenalidomide|"Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243846|NCT01057121|E3|Reported Event|Phase I: 20 mg/Day Lenalidomide|"Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243847|NCT01057121|E2|Reported Event|Phase I: 15 mg/Day Lenalidomide|"Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243848|NCT01057121|E1|Reported Event|Phase I: 10 mg/Day Lenalidomide|"Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
243849|NCT01057017|B1|Baseline|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
243850|NCT01057017|P1|Participant Flow|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
243851|NCT01057017|O1|Outcome|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
243852|NCT01057017|E1|Reported Event|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
243853|NCT01056913|B1|Baseline|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
243854|NCT01056913|P1|Participant Flow|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
243855|NCT01056913|O1|Outcome|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
243856|NCT01056913|E1|Reported Event|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
243857|NCT01056822|B3|Baseline|Total|Total of all reporting groups
243858|NCT01056822|B2|Baseline|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243859|NCT01056822|B1|Baseline|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243860|NCT01056822|P2|Participant Flow|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243861|NCT01056822|P1|Participant Flow|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243862|NCT01056822|O1|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243863|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243864|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243865|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243866|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
244089|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244090|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
243867|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243868|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243869|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243870|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243871|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243872|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243873|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243874|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243875|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243876|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243877|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243878|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243879|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243880|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243913|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243881|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243882|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243883|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243884|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243885|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243886|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243887|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243888|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243889|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243890|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243891|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243892|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243893|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243894|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243914|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243895|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243896|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243897|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243898|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243899|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243900|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243901|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243902|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243903|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243904|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243905|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
243906|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
243907|NCT01056822|E2|Reported Event|Micofenolato Mofetilo|Micofenolato mofetilo
243908|NCT01056822|E1|Reported Event|Micofenolato Sodium|Micofenolato sodium
243909|NCT01056718|B1|Baseline|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243910|NCT01056718|P1|Participant Flow|Nebivolol Treatment|10 week open label nebivolol treatment.
243911|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243912|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
249303|NCT01037244|E4|Reported Event|Placebo|Placebo tablets
243915|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243916|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243917|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243918|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243919|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243920|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243921|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243922|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243923|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243924|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243925|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243926|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243927|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243928|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243929|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243930|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243931|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243932|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243933|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243934|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243935|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243936|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
244091|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
243937|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243938|NCT01056718|E1|Reported Event|Starting on 5 mg of Nebivolol Then Titrated|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
243939|NCT01056640|B3|Baseline|Total|Total of all reporting groups
243940|NCT01056640|B2|Baseline|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
243941|NCT01056640|B1|Baseline|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
243942|NCT01056640|P2|Participant Flow|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
243943|NCT01056640|P1|Participant Flow|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
243944|NCT01056640|O2|Outcome|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
243945|NCT01056640|O1|Outcome|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
243946|NCT01056640|E2|Reported Event|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
243947|NCT01056640|E1|Reported Event|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
243948|NCT01056601|B1|Baseline|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
243949|NCT01056601|P1|Participant Flow|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
243950|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
244092|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
243951|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
243952|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
243953|NCT01056601|E1|Reported Event|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
243954|NCT01056523|B1|Baseline|Ribavirin and Cytarabine|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
243955|NCT01056523|P7|Participant Flow|Dose Level 7|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
243956|NCT01056523|P6|Participant Flow|Dose Level 6|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
243957|NCT01056523|P5|Participant Flow|Dose Level 5|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
243958|NCT01056523|P4|Participant Flow|Dose Level 4|Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
243959|NCT01056523|P3|Participant Flow|Dose Level 3|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
243960|NCT01056523|P2|Participant Flow|Dose Level 2|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
243961|NCT01056523|P1|Participant Flow|Dose Level 1|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
243962|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
243963|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
243964|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
243965|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
243966|NCT01056523|O1|Outcome|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
243967|NCT01056523|E1|Reported Event|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
243968|NCT01056510|B3|Baseline|Total|Total of all reporting groups
243969|NCT01056510|B2|Baseline|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243970|NCT01056510|B1|Baseline|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243971|NCT01056510|P2|Participant Flow|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243972|NCT01056510|P1|Participant Flow|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD).
243973|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244067|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244068|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244069|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
243974|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243975|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243976|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243977|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243978|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243979|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243980|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243981|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243982|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243983|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243984|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243985|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243986|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243987|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244070|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244071|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter
244072|NCT01056328|O1|Outcome|St Jude Medical (SJM) Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
243988|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243989|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243990|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243991|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243992|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243993|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243994|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243995|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243996|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243997|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243998|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
243999|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244000|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244001|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244073|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244074|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244075|NCT01056328|E2|Reported Event|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244002|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244003|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244004|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244005|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244006|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244007|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244008|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244009|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244010|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244011|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244012|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244013|NCT01056510|E2|Reported Event|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244014|NCT01056510|E1|Reported Event|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
244015|NCT01056484|B3|Baseline|Total|Total of all reporting groups
244016|NCT01056484|B2|Baseline|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244076|NCT01056328|E1|Reported Event|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244077|NCT01056315|B3|Baseline|Total|Total of all reporting groups
244078|NCT01056315|B2|Baseline|Placebo|
244079|NCT01056315|B1|Baseline|GRT3983Y|
244080|NCT01056315|P2|Participant Flow|Placebo|
244017|NCT01056484|B1|Baseline|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244018|NCT01056484|P2|Participant Flow|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244019|NCT01056484|P1|Participant Flow|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244020|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244021|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244022|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244023|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244024|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
244025|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
244026|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244027|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244028|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244081|NCT01056315|P1|Participant Flow|GRT3983Y|
244082|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244083|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244029|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244030|NCT01056484|E2|Reported Event|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
244031|NCT01056484|E1|Reported Event|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
244032|NCT01056341|B6|Baseline|Total|Total of all reporting groups
244033|NCT01056341|B5|Baseline|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
244034|NCT01056341|B4|Baseline|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
244035|NCT01056341|B3|Baseline|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
244036|NCT01056341|B2|Baseline|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
244037|NCT01056341|B1|Baseline|Placebo|Placebo: Treatment with placebo for 6 months
244038|NCT01056341|P5|Participant Flow|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
244039|NCT01056341|P4|Participant Flow|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
244040|NCT01056341|P3|Participant Flow|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
244041|NCT01056341|P2|Participant Flow|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
244042|NCT01056341|P1|Participant Flow|Placebo|Placebo: Treatment with placebo for 6 months
244043|NCT01056341|O2|Outcome|Propranolol 3mg/kg/d 6 Months|Propranolol 3 mg/kg/day for 6 months
244044|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
244045|NCT01056341|O5|Outcome|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
244046|NCT01056341|O4|Outcome|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
244047|NCT01056341|O3|Outcome|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
244048|NCT01056341|O2|Outcome|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
244049|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
244050|NCT01056341|E10|Reported Event|W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
244051|NCT01056341|E9|Reported Event|W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
244052|NCT01056341|E8|Reported Event|W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
244053|NCT01056341|E7|Reported Event|W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
244054|NCT01056341|E6|Reported Event|W72-follow-up Period of ex Placebo Group-safety Set|72-week follow-up period without study treatment administration
244055|NCT01056341|E5|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
244056|NCT01056341|E4|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months
244057|NCT01056341|E3|Reported Event|W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 6 months
244058|NCT01056341|E2|Reported Event|W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months
244059|NCT01056341|E1|Reported Event|W24-treatment Period-safety Set-Placebo|Placebo: Treatment with placebo for 6 months
244060|NCT01056328|B3|Baseline|Total|Total of all reporting groups
244061|NCT01056328|B2|Baseline|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244062|NCT01056328|B1|Baseline|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244063|NCT01056328|P2|Participant Flow|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244064|NCT01056328|P1|Participant Flow|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244065|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
244066|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
244093|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244094|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244095|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244096|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244097|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244098|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244099|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244100|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244101|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244102|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244103|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244104|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244105|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244106|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244107|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244108|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244109|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244110|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
244111|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
244112|NCT01056315|E2|Reported Event|Placebo|
244113|NCT01056315|E1|Reported Event|GRT3983Y|
244114|NCT01056289|B1|Baseline|Entire Study Population|24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
244115|NCT01056289|P4|Participant Flow|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244116|NCT01056289|P3|Participant Flow|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244117|NCT01056289|P2|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
244118|NCT01056289|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
244119|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244120|NCT01056289|O2|Outcome|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244121|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
244122|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244123|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244124|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
244125|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244126|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244127|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
244128|NCT01056289|E4|Reported Event|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244129|NCT01056289|E3|Reported Event|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
244130|NCT01056289|E2|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
244131|NCT01056289|E1|Reported Event|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 24 Weeks.
244132|NCT01056263|B1|Baseline|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
244133|NCT01056263|P1|Participant Flow|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
244134|NCT01056263|O1|Outcome|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
244135|NCT01056263|E1|Reported Event|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
244136|NCT01056198|B3|Baseline|Total|Total of all reporting groups
244137|NCT01056198|B2|Baseline|Control|Daily gauze and optional sharp debridement
244138|NCT01056198|B1|Baseline|Santyl|2 mm Santyl once daily (QD)
244139|NCT01056198|P2|Participant Flow|Control|Daily gauze and optional sharp debridement
244140|NCT01056198|P1|Participant Flow|Santyl|2 mm Santyl once daily (QD)
244141|NCT01056198|O1|Outcome|Control|Daily gauze and optional sharp debridement
244142|NCT01056198|O1|Outcome|Santyl|2 mm Santyl QD
244143|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
244144|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
244145|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
244146|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
244147|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
244148|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
244149|NCT01056198|E2|Reported Event|Control|Daily gauze and optional sharp debridement
244150|NCT01056198|E1|Reported Event|Santyl|2 mm Santyl once daily (QD)
244151|NCT01056107|B5|Baseline|Total|Total of all reporting groups
244152|NCT01056107|B4|Baseline|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244153|NCT01056107|B3|Baseline|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244154|NCT01056107|B2|Baseline|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244155|NCT01056107|B1|Baseline|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244156|NCT01056107|P4|Participant Flow|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244157|NCT01056107|P3|Participant Flow|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244158|NCT01056107|P2|Participant Flow|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244159|NCT01056107|P1|Participant Flow|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244160|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244161|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244162|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244163|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244164|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244165|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244166|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244167|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244168|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244169|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244170|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244171|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244172|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244173|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244174|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244175|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244176|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244177|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244735|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244178|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244179|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244180|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244181|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244182|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244183|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244184|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244185|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244186|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244187|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244188|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244189|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244190|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244191|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244192|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244193|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244194|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244195|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244196|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244197|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244198|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244199|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244200|NCT01056107|E4|Reported Event|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244201|NCT01056107|E3|Reported Event|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244202|NCT01056107|E2|Reported Event|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244203|NCT01056107|E1|Reported Event|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
244204|NCT01056016|B3|Baseline|Total|Total of all reporting groups
244205|NCT01056016|B2|Baseline|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
244206|NCT01056016|B1|Baseline|Wait-list Control|Wait-list control group
244230|NCT01055834|P1|Participant Flow|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.
244604|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244736|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244207|NCT01056016|P2|Participant Flow|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
244208|NCT01056016|P1|Participant Flow|Wait-list Control|Wait-list control group
244209|NCT01056016|O2|Outcome|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
244210|NCT01056016|O1|Outcome|Wait-list Control|Wait-list control group
244211|NCT01056016|E2|Reported Event|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
244212|NCT01056016|E1|Reported Event|Wait-list Control|Wait-list control group
244213|NCT01055886|B3|Baseline|Total|Total of all reporting groups
244214|NCT01055886|B2|Baseline|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244215|NCT01055886|B1|Baseline|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244216|NCT01055886|P2|Participant Flow|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244217|NCT01055886|P1|Participant Flow|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244218|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244219|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244220|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244221|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244222|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244223|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244224|NCT01055886|E2|Reported Event|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
244225|NCT01055886|E1|Reported Event|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
244226|NCT01055834|B3|Baseline|Total|Total of all reporting groups
244227|NCT01055834|B2|Baseline|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations."
244228|NCT01055834|B1|Baseline|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.
244229|NCT01055834|P2|Participant Flow|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations."
244231|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244232|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244233|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244234|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244235|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244236|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
244237|NCT01055834|E4|Reported Event|Eszopiclone One 3 mg Tablet (Fasted)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
244238|NCT01055834|E3|Reported Event|Eszopiclone One 3 mg Tablet (Fed)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions.
244239|NCT01055834|E2|Reported Event|Eszopiclone Three 1 mg Tablets|Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
244240|NCT01055834|E1|Reported Event|Eszopiclone One 3 mg Tablet|Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
244241|NCT01055782|B3|Baseline|Total|Total of all reporting groups
244242|NCT01055782|B2|Baseline|Without Endoguide|Colonoscopy completed without endoguide
244243|NCT01055782|B1|Baseline|With Endoguide|Colonoscopy completed with endoguide
244244|NCT01055782|P2|Participant Flow|Without Endoguide|Colonoscopy completed without endoguide
244245|NCT01055782|P1|Participant Flow|With Endoguide|Colonoscopy completed with endoguide
244246|NCT01055782|O2|Outcome|Without Endoguide|Colonoscopy completed without endoguide
244247|NCT01055782|O1|Outcome|With Endoguide|Colonoscopy completed with endoguide
244248|NCT01055782|O2|Outcome|Without Endoguide|Exams completed without endoguide. Success rate/completion.
244249|NCT01055782|O1|Outcome|With Endoguide - Success Rate|Exams completed with endoguide. Success rate/completion.
244250|NCT01055782|E2|Reported Event|Without Endoguide|Colonoscopy completed without endoguide
244251|NCT01055782|E1|Reported Event|With Endoguide|Colonoscopy completed with endoguide
244252|NCT01055769|B1|Baseline|Linezolid|Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244253|NCT01055769|P2|Participant Flow|Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
244532|NCT01054885|E3|Reported Event|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244254|NCT01055769|P1|Participant Flow|Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
244255|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244256|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244257|NCT01055769|O2|Outcome|Linezolid 600mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244258|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244259|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244260|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244261|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244262|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244263|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244264|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244265|NCT01055769|E2|Reported Event|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244266|NCT01055769|E1|Reported Event|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
244267|NCT01055704|B5|Baseline|Total|Total of all reporting groups
244268|NCT01055704|B4|Baseline|Placebo|
244269|NCT01055704|B3|Baseline|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244270|NCT01055704|B2|Baseline|Codeine 30 mg|
244271|NCT01055704|B1|Baseline|Methylnaltrexone 0.30 mg/kg|
244272|NCT01055704|P4|Participant Flow|Placebo|
244273|NCT01055704|P3|Participant Flow|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244274|NCT01055704|P2|Participant Flow|Codeine 30 mg|
244275|NCT01055704|P1|Participant Flow|Methylnaltrexone 0.30 mg/kg|
244276|NCT01055704|O4|Outcome|Placebo|
244277|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244278|NCT01055704|O2|Outcome|Codeine 30 mg|
244279|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244280|NCT01055704|O4|Outcome|Placebo|
244281|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244282|NCT01055704|O2|Outcome|Codeine 30 mg|
244283|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244284|NCT01055704|O4|Outcome|Placebo|
244285|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244286|NCT01055704|O2|Outcome|Codeine 30 mg|
244287|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244288|NCT01055704|O4|Outcome|Placebo|
244289|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244290|NCT01055704|O2|Outcome|Codeine 30 mg|
244291|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244292|NCT01055704|O4|Outcome|Placebo|
244293|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244294|NCT01055704|O2|Outcome|Codeine 30 mg|
244295|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244296|NCT01055704|O4|Outcome|Placebo|
244297|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244298|NCT01055704|O2|Outcome|Codeine 30 mg|
244299|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244300|NCT01055704|O4|Outcome|Placebo|
244301|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244302|NCT01055704|O2|Outcome|Codeine 30 mg|
244303|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244304|NCT01055704|O4|Outcome|Placebo|
244305|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244306|NCT01055704|O2|Outcome|Codeine 30 mg|
244307|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
244308|NCT01055704|E4|Reported Event|Placebo|
244309|NCT01055704|E3|Reported Event|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
244310|NCT01055704|E2|Reported Event|Codeine 30 mg|
244311|NCT01055704|E1|Reported Event|Methylnaltrexone 0.30 mg/kg|
244312|NCT01055639|B3|Baseline|Total|Total of all reporting groups
244313|NCT01055639|B2|Baseline|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244314|NCT01055639|B1|Baseline|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244315|NCT01055639|P2|Participant Flow|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244533|NCT01054885|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244316|NCT01055639|P1|Participant Flow|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244317|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244318|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244319|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244320|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244321|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244322|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244323|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244324|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244325|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244326|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244327|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244328|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244329|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244330|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244331|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244332|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244333|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244334|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244669|NCT01054586|B2|Baseline|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244335|NCT01055639|E2|Reported Event|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244336|NCT01055639|E1|Reported Event|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
244337|NCT01055613|B3|Baseline|Total|Total of all reporting groups
244338|NCT01055613|B2|Baseline|ReNu Multi-purpose Solution|Marketed multi-purpose solution (Control Treatment).
244339|NCT01055613|B1|Baseline|Experimental Mutli-purpose Solution|Experimental multi-purpose solution (Test treatment) .
244340|NCT01055613|P2|Participant Flow|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
244341|NCT01055613|P1|Participant Flow|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
244342|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
244343|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
244344|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
244345|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
244346|NCT01055613|E2|Reported Event|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
244347|NCT01055613|E1|Reported Event|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
244348|NCT01055457|B1|Baseline|Dispensed Subjects|All subjects that were dispensed a study lens and solution.
244349|NCT01055457|P10|Participant Flow|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244350|NCT01055457|P9|Participant Flow|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244351|NCT01055457|P8|Participant Flow|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244352|NCT01055457|P7|Participant Flow|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244353|NCT01055457|P6|Participant Flow|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244354|NCT01055457|P5|Participant Flow|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244355|NCT01055457|P4|Participant Flow|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244356|NCT01055457|P3|Participant Flow|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244357|NCT01055457|P2|Participant Flow|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244358|NCT01055457|P1|Participant Flow|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244359|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244360|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244361|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244362|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244363|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244364|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244365|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244366|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244367|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244368|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244369|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244370|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244371|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244372|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244373|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244374|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244375|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244376|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244377|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244378|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244379|NCT01055457|E10|Reported Event|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244380|NCT01055457|E9|Reported Event|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244381|NCT01055457|E8|Reported Event|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244382|NCT01055457|E7|Reported Event|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244383|NCT01055457|E6|Reported Event|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
244384|NCT01055457|E5|Reported Event|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244385|NCT01055457|E4|Reported Event|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244386|NCT01055457|E3|Reported Event|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244387|NCT01055457|E2|Reported Event|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244388|NCT01055457|E1|Reported Event|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
244389|NCT01055262|B1|Baseline|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244390|NCT01055262|P1|Participant Flow|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244391|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244392|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244393|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244394|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244395|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244396|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244397|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244398|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244399|NCT01055262|E1|Reported Event|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
244400|NCT01055223|B1|Baseline|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
244401|NCT01055223|P1|Participant Flow|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
244402|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
244403|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244404|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244405|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
244406|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
244407|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244408|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244409|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
244410|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
244411|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244412|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244413|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
244414|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
244415|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244416|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244417|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
244418|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
244419|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244420|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244421|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
244422|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
244423|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
244534|NCT01054885|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244535|NCT01054846|B3|Baseline|Total|Total of all reporting groups
244424|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
244425|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
244426|NCT01055223|E2|Reported Event|TZD-12 Month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
244427|NCT01055223|E1|Reported Event|TZD 6-month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
244428|NCT01055197|B3|Baseline|Total|Total of all reporting groups
244429|NCT01055197|B2|Baseline|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
244430|NCT01055197|B1|Baseline|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
244431|NCT01055197|P2|Participant Flow|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
244432|NCT01055197|P1|Participant Flow|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
244433|NCT01055197|O2|Outcome|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
244434|NCT01055197|O1|Outcome|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
244435|NCT01055197|E2|Reported Event|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
244436|NCT01055197|E1|Reported Event|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
244437|NCT01055184|B1|Baseline|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
244438|NCT01055184|P1|Participant Flow|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
244439|NCT01055184|O1|Outcome|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
244440|NCT01055184|E1|Reported Event|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
244441|NCT01055171|B3|Baseline|Total|Total of all reporting groups
244442|NCT01055171|B2|Baseline|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
244443|NCT01055171|B1|Baseline|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
244444|NCT01055171|P2|Participant Flow|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244445|NCT01055171|P1|Participant Flow|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244446|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244447|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244448|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244449|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244450|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244451|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244452|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244453|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244601|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244602|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244454|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
244455|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
244456|NCT01055171|E2|Reported Event|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
244457|NCT01055171|E1|Reported Event|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
244458|NCT01055132|B1|Baseline|All Subjects|All subjects who completed the study.
244459|NCT01055132|P2|Participant Flow|Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second|Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
244460|NCT01055132|P1|Participant Flow|Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second|Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
244461|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days.
244462|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
244463|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days
244464|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
244465|NCT01055132|O2|Outcome|Nelfilcon A Toric Lens (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
244466|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
244467|NCT01055132|O2|Outcome|Nelfilcon A Toric (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
244468|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
244469|NCT01055132|E1|Reported Event|Etafilcon A Toric / Nelfilcon A Toric|etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
244470|NCT01054976|B1|Baseline|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244471|NCT01054976|P1|Participant Flow|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244472|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244473|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244474|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244475|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244476|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244477|NCT01054976|E1|Reported Event|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
244478|NCT01054911|B1|Baseline|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
244479|NCT01054911|P1|Participant Flow|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
244480|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
244481|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
244482|NCT01054911|O2|Outcome|Neoadjuvant Therapy no Surgery|Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
244483|NCT01054911|O1|Outcome|Neoadjuvant Therapy Plus Surgery|Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
244484|NCT01054911|E1|Reported Event|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
244485|NCT01054885|B7|Baseline|Total|Total of all reporting groups
244486|NCT01054885|B6|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244487|NCT01054885|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244488|NCT01054885|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244489|NCT01054885|B3|Baseline|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244490|NCT01054885|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244491|NCT01054885|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244492|NCT01054885|P7|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244493|NCT01054885|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244494|NCT01054885|P5|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
244495|NCT01054885|P4|Participant Flow|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244496|NCT01054885|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
244497|NCT01054885|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
244498|NCT01054885|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
244499|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244500|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244501|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244502|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244503|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244504|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244505|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244506|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244507|NCT01054885|O4|Outcome|FVI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244508|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244509|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244510|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244511|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244512|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244513|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244514|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244515|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244516|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244517|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244518|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244519|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244520|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244521|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244522|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244523|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244524|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244525|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244526|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
244527|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244528|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244529|NCT01054885|E6|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
244530|NCT01054885|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244531|NCT01054885|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
249304|NCT01037244|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
244536|NCT01054846|B2|Baseline|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
244537|NCT01054846|B1|Baseline|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
244538|NCT01054846|P2|Participant Flow|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
244539|NCT01054846|P1|Participant Flow|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
244540|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
244541|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
244542|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
244543|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
244544|NCT01054846|E1|Reported Event|All Study Participants|
244545|NCT01054820|B1|Baseline|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244546|NCT01054820|P1|Participant Flow|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244547|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244548|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244549|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244550|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244551|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244552|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244553|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244554|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244555|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244603|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244556|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244557|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244558|NCT01054820|E1|Reported Event|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
244559|NCT01054742|B1|Baseline|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
244560|NCT01054742|P1|Participant Flow|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
244561|NCT01054742|O1|Outcome|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
244562|NCT01054742|E1|Reported Event|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
244563|NCT01054729|B5|Baseline|Total|Total of all reporting groups
244564|NCT01054729|B4|Baseline|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244565|NCT01054729|B3|Baseline|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244566|NCT01054729|B2|Baseline|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244567|NCT01054729|B1|Baseline|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244568|NCT01054729|P4|Participant Flow|Placebo+PEG+RBV|Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
244569|NCT01054729|P3|Participant Flow|Sofosbuvir 400 mg+PEG+RBV|Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
244570|NCT01054729|P2|Participant Flow|Sofosbuvir 200 mg+PEG+RBV|Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
244571|NCT01054729|P1|Participant Flow|Sofosbuvir 100 mg+PEG+RBV|Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
244572|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244573|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244574|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244575|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244576|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244577|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244578|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244579|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244580|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244581|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244582|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244583|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244584|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244585|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244586|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244587|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244588|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244589|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244590|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244591|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244592|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244593|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244594|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244595|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244596|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244597|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244598|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244599|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244600|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244605|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244606|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244607|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244608|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244609|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244610|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244611|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244612|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244613|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244614|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244615|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244616|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244617|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244618|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244619|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244620|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244621|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244622|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244623|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244624|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244625|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244626|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244627|NCT01054729|E4|Reported Event|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
244628|NCT01054729|E3|Reported Event|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
244629|NCT01054729|E2|Reported Event|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
244630|NCT01054729|E1|Reported Event|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
244631|NCT01054703|B1|Baseline|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
244632|NCT01054703|P1|Participant Flow|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
244633|NCT01054703|O1|Outcome|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
244634|NCT01054703|E1|Reported Event|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
244635|NCT01054625|B4|Baseline|Total|Total of all reporting groups
244636|NCT01054625|B3|Baseline|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244637|NCT01054625|B2|Baseline|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244638|NCT01054625|B1|Baseline|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244639|NCT01054625|P3|Participant Flow|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244640|NCT01054625|P2|Participant Flow|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244641|NCT01054625|P1|Participant Flow|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244642|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244643|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244644|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244645|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244646|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244647|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244648|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244649|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244650|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244651|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244652|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244653|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244654|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244655|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244656|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244657|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244658|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244659|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244660|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244661|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244662|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244663|NCT01054625|E3|Reported Event|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
244664|NCT01054625|E2|Reported Event|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
244665|NCT01054625|E1|Reported Event|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
244666|NCT01054586|B5|Baseline|Total|Total of all reporting groups
244667|NCT01054586|B4|Baseline|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244668|NCT01054586|B3|Baseline|FPV, Other|All other dosages of Fosamprenavir
244670|NCT01054586|B1|Baseline|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244671|NCT01054586|P4|Participant Flow|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244672|NCT01054586|P3|Participant Flow|FPV, Other|All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
244673|NCT01054586|P2|Participant Flow|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244674|NCT01054586|P1|Participant Flow|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244675|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244676|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244677|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244678|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244679|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244680|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244681|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244682|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244683|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
244684|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
244685|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244686|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244687|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244688|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244689|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244690|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244691|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244692|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244693|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
244694|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244695|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244696|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244697|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244698|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244699|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244700|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244701|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244702|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244703|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244704|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244705|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244706|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244707|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244708|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244709|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244710|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244711|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244712|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244713|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244714|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244715|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244716|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244717|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244718|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244719|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244720|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244721|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244722|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244723|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244724|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244725|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
244726|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244727|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244728|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
244729|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|
244730|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
244731|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244732|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
244733|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244734|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244737|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244738|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244739|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244740|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244741|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244742|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244743|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
244744|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244745|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244746|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244747|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244748|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244749|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244750|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244751|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244752|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244753|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244754|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244755|NCT01054586|O2|Outcome|Not ART naïve|Patients who have previously been exposed to ART therapy
244756|NCT01054586|O1|Outcome|ART naïve|Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
244757|NCT01054586|E4|Reported Event|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
244758|NCT01054586|E3|Reported Event|FPV, Other|All other dosages of Fosamprenavir
244759|NCT01054586|E2|Reported Event|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
244760|NCT01054586|E1|Reported Event|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
244761|NCT01054573|B5|Baseline|Total|Total of all reporting groups
244762|NCT01054573|B4|Baseline|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244763|NCT01054573|B3|Baseline|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244764|NCT01054573|B2|Baseline|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244765|NCT01054573|B1|Baseline|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244766|NCT01054573|P4|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244767|NCT01054573|P3|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244768|NCT01054573|P2|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244769|NCT01054573|P1|Participant Flow|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244770|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively.
244771|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively.
244789|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244772|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 20, 19, and 16, respectively.
244773|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 31, 23, 18, and 15, respectively.
244774|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively.
244775|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively.
244776|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 22, 20, 19, and 16, respectively.
244777|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 32, 31, 23, 18, and 16, respectively.
244778|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244779|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244780|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244781|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244782|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244783|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244784|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244785|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244786|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244787|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244788|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244857|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244790|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244791|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244792|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244793|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244794|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244795|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244796|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244797|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244798|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244799|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244800|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244801|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244802|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244803|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244804|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244805|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244806|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244807|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
244808|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
244858|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
249306|NCT01037244|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
244809|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
244810|NCT01054573|E2|Reported Event|Phase 3: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
244811|NCT01054573|E1|Reported Event|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
244812|NCT01054560|B3|Baseline|Total|Total of all reporting groups
244813|NCT01054560|B2|Baseline|MERCI® Device|The MERCI® Device (control device) is commercially available.
244814|NCT01054560|B1|Baseline|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244815|NCT01054560|P2|Participant Flow|MERCI® Device|The MERCI® Device (control device) is commercially available.
244816|NCT01054560|P1|Participant Flow|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244817|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
244818|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
244819|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
244820|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
244821|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
244822|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
244823|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244824|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244825|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244826|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244827|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244828|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244829|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244830|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244831|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244832|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244833|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
244834|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244835|NCT01054560|E2|Reported Event|The MERCI® Device|The MERCI® Device (control device) is commercially available.
244836|NCT01054560|E1|Reported Event|The SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
244837|NCT01054404|B3|Baseline|Total|Total of all reporting groups
244838|NCT01054404|B2|Baseline|Placebo|Placebo : Placebo (up to 5mL)
244839|NCT01054404|B1|Baseline|Furosemide|Furosemide : Furosemide 0.3 mg/kg
244840|NCT01054404|P2|Participant Flow|Placebo|Placebo : Placebo (up to 5mL)
244841|NCT01054404|P1|Participant Flow|Furosemide|Furosemide : Furosemide 0.3 mg/kg
244842|NCT01054404|O2|Outcome|Placebo|Placebo : Placebo (up to 5mL)
244843|NCT01054404|O1|Outcome|Furosemide|Furosemide : Furosemide 0.3 mg/kg
244844|NCT01054404|E2|Reported Event|Placebo|Placebo : Placebo (up to 5mL)
244845|NCT01054404|E1|Reported Event|Furosemide|Furosemide : Furosemide 0.3 mg/kg
244846|NCT01054339|B4|Baseline|Total|Total of all reporting groups
244847|NCT01054339|B3|Baseline|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244848|NCT01054339|B2|Baseline|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244849|NCT01054339|B1|Baseline|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
244850|NCT01054339|P3|Participant Flow|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244851|NCT01054339|P2|Participant Flow|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244852|NCT01054339|P1|Participant Flow|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
244853|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244854|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244855|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
244856|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244859|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244860|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244861|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
244862|NCT01054339|E3|Reported Event|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
244863|NCT01054339|E2|Reported Event|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
244864|NCT01054339|E1|Reported Event|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
244865|NCT01054222|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244866|NCT01054222|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244867|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244868|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244869|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244870|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244871|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244872|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244873|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244874|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244875|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244876|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244877|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244878|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244879|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244880|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244881|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244882|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244883|NCT01054222|E1|Reported Event|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
244884|NCT01054183|B3|Baseline|Total|Total of all reporting groups
244885|NCT01054183|B2|Baseline|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
244886|NCT01054183|B1|Baseline|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
244887|NCT01054183|P2|Participant Flow|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
244888|NCT01054183|P1|Participant Flow|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
244889|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
244890|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
244891|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
244960|NCT01053988|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244892|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
244893|NCT01054183|E2|Reported Event|Direct Laryngoscopy|Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
244894|NCT01054183|E1|Reported Event|GlideScope Video Laryngoscope Ranger(GVL)|Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.
244895|NCT01054170|B3|Baseline|Total|Total of all reporting groups
244896|NCT01054170|B2|Baseline|Placebo|Placebo 2 tablets bid
244897|NCT01054170|B1|Baseline|AZD9668|AZD9668 2x30mg bid
244898|NCT01054170|P2|Participant Flow|Placebo|Placebo 2 tablets bid
244899|NCT01054170|P1|Participant Flow|AZD9668|AZD9668 2x30mg bid
244900|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244901|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244902|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244903|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244904|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244905|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244906|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244907|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244908|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244909|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244910|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244911|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244912|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244913|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244914|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244915|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244916|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244917|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244918|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244919|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244920|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244921|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244922|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244923|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244924|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244925|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244926|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244927|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244928|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244929|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244930|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244931|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244932|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244933|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244934|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244935|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244936|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244937|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244938|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244939|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244940|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244941|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244942|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244943|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244944|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244945|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244946|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
244947|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
244948|NCT01054170|E2|Reported Event|Placebo|Placebo 2 tablets bid
244949|NCT01054170|E1|Reported Event|AZD9668|AZD9668 2x30mg bid
244950|NCT01054079|B1|Baseline|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
244951|NCT01054079|P1|Participant Flow|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
244952|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
244953|NCT01054079|E1|Reported Event|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
244954|NCT01053988|B6|Baseline|Total|Total of all reporting groups
244955|NCT01053988|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244956|NCT01053988|B4|Baseline|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244957|NCT01053988|B3|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244958|NCT01053988|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244959|NCT01053988|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244961|NCT01053988|P5|Participant Flow|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244962|NCT01053988|P4|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
244963|NCT01053988|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
244964|NCT01053988|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
244965|NCT01053988|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
244966|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244967|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244968|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244969|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244970|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244971|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244972|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244973|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244974|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244975|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244976|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244977|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244978|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244979|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244980|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244981|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244982|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244983|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244984|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244985|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244986|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244987|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244988|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244989|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244990|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244991|NCT01053988|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
244992|NCT01053988|E4|Reported Event|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
244993|NCT01053988|E3|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
244994|NCT01053988|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
244995|NCT01053988|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
244996|NCT01053897|B1|Baseline|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
244997|NCT01053897|P1|Participant Flow|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
244998|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
244999|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
245000|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
245001|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
245002|NCT01053897|O3|Outcome|No Difference|No scar segment was preferred to the other
245003|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment preferred
245004|NCT01053897|O1|Outcome|GBT009|GBT009 treated scar segment preferred
245005|NCT01053897|O2|Outcome|Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
245006|NCT01053897|O1|Outcome|GBT009|All subjects acted as their own control receiving both GBT009 and Placebo
245007|NCT01053897|E1|Reported Event|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
245008|NCT01053819|B1|Baseline|Etanercept|open label treatment per FDA approval for 24 weeks
245009|NCT01053819|P1|Participant Flow|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
245010|NCT01053819|O1|Outcome|Etanercept|open label treatment per FDA approval for 24 weeks
245011|NCT01053819|E1|Reported Event|Etanercept|open label treatment per FDA approval for 24 weeks
245012|NCT01053663|B4|Baseline|Total|Total of all reporting groups
245013|NCT01053663|B3|Baseline|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245014|NCT01053663|B2|Baseline|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245015|NCT01053663|B1|Baseline|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245016|NCT01053663|P1|Participant Flow|Oseltamivir - All Participants|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245017|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245018|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245019|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245020|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245021|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245022|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245023|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245024|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245025|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245026|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245027|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245028|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245029|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245030|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245031|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245032|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245033|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245034|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245035|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245036|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245037|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245038|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245039|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245040|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245041|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245042|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245043|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245044|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
249307|NCT01037218|B5|Baseline|Total|Total of all reporting groups
245045|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245046|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245047|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245048|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245049|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245050|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245051|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245052|NCT01053663|E4|Reported Event|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245053|NCT01053663|E3|Reported Event|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245054|NCT01053663|E2|Reported Event|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245055|NCT01053663|E1|Reported Event|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
245056|NCT01053507|B3|Baseline|Total|Total of all reporting groups
245057|NCT01053507|B2|Baseline|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245058|NCT01053507|B1|Baseline|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245059|NCT01053507|P2|Participant Flow|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245060|NCT01053507|P1|Participant Flow|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245061|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245090|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245062|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245063|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245064|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245065|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245066|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245067|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245068|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245069|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245070|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245071|NCT01053507|E2|Reported Event|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245072|NCT01053507|E1|Reported Event|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
245073|NCT01053429|B1|Baseline|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245074|NCT01053429|P1|Participant Flow|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245075|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245076|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245077|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245078|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245079|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245080|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245081|NCT01053429|E1|Reported Event|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
245082|NCT01053312|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
245083|NCT01053312|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
245084|NCT01053312|O1|Outcome|Amyloid Level (Plaque Load)|Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.
245085|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245086|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245087|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245088|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245089|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245091|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
245092|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245093|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245094|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245095|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245096|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245097|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245098|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
245099|NCT01053312|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
245100|NCT01053247|B4|Baseline|Total|Total of all reporting groups
245101|NCT01053247|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
245102|NCT01053247|B2|Baseline|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
245103|NCT01053247|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
245104|NCT01053247|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
245105|NCT01053247|P2|Participant Flow|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
245106|NCT01053247|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
245107|NCT01053247|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
245108|NCT01053247|O2|Outcome|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
245109|NCT01053247|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
245110|NCT01053247|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
245111|NCT01053247|E2|Reported Event|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
245112|NCT01053247|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
245113|NCT01053156|B3|Baseline|Total|Total of all reporting groups
245114|NCT01053156|B2|Baseline|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
245115|NCT01053156|B1|Baseline|Minocycline First, Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
245116|NCT01053156|P2|Participant Flow|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
245117|NCT01053156|P1|Participant Flow|Minocycline First, Then Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
245118|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245119|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245120|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245121|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245122|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245123|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245124|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245125|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245126|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245127|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245128|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245129|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245130|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245255|NCT01052428|B1|Baseline|Placebo|
245131|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245132|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245133|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245134|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245135|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245136|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245137|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245138|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245139|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245140|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245141|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245142|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245143|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245144|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245145|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245146|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245147|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
245148|NCT01053156|O2|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245149|NCT01053156|O1|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245150|NCT01053156|E2|Reported Event|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245151|NCT01053156|E1|Reported Event|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
245152|NCT01053078|B3|Baseline|Total|Total of all reporting groups
245153|NCT01053078|B2|Baseline|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245154|NCT01053078|B1|Baseline|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245155|NCT01053078|P2|Participant Flow|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245156|NCT01053078|P1|Participant Flow|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245157|NCT01053078|O2|Outcome|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245158|NCT01053078|O1|Outcome|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245159|NCT01053078|E2|Reported Event|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245160|NCT01053078|E1|Reported Event|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
245161|NCT01053000|B1|Baseline|All Study Participants|"Tazorac o.1% gel foer 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
245162|NCT01053000|P2|Participant Flow|Right Arm Tazorac/Left Arm No Pretreatment|Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
245163|NCT01053000|P1|Participant Flow|Left Arm Tazorac/Right Arm No Tazorac Pre-treatment|Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
245164|NCT01053000|O2|Outcome|No Pretreatment With Tzorac|"No pretreatmnet to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
245165|NCT01053000|O1|Outcome|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
245166|NCT01053000|E2|Reported Event|No Pretreatment Arm|"No Pretreatment to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
245167|NCT01053000|E1|Reported Event|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
245168|NCT01052948|B5|Baseline|Total|Total of all reporting groups
245169|NCT01052948|B4|Baseline|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245170|NCT01052948|B3|Baseline|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245171|NCT01052948|B2|Baseline|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245172|NCT01052948|B1|Baseline|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245173|NCT01052948|P4|Participant Flow|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245174|NCT01052948|P3|Participant Flow|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245175|NCT01052948|P2|Participant Flow|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245176|NCT01052948|P1|Participant Flow|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245177|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245178|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245179|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245180|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245181|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245182|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245183|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245184|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245185|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245186|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245187|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245188|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245189|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245190|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245191|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245192|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245193|NCT01052948|E4|Reported Event|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
245194|NCT01052948|E3|Reported Event|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
245195|NCT01052948|E2|Reported Event|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
245196|NCT01052948|E1|Reported Event|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
245197|NCT01052844|B3|Baseline|Total|Total of all reporting groups
245198|NCT01052844|B2|Baseline|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245199|NCT01052844|B1|Baseline|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245200|NCT01052844|P2|Participant Flow|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245201|NCT01052844|P1|Participant Flow|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245202|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245203|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245204|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245205|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245206|NCT01052844|E2|Reported Event|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245207|NCT01052844|E1|Reported Event|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
245208|NCT01052831|B3|Baseline|Total|Total of all reporting groups
245209|NCT01052831|B2|Baseline|Placebo|"Participants will receive placebo treatment~Placebo: 50-100 mg qd for 8 weeks"
245210|NCT01052831|B1|Baseline|Naltrexone|"Participants will receive Naltrexone~Naltrexone: 50-100 mg qd for 8 weeks"
245211|NCT01052831|P2|Participant Flow|Placebo|Participants received the placebo treatment which looked identical to active study medication.
245212|NCT01052831|P1|Participant Flow|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
245213|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
245214|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
245215|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
245216|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
245217|NCT01052831|E2|Reported Event|Placebo|Participants received the placebo treatment which looked identical to active study medication.
245218|NCT01052831|E1|Reported Event|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
245219|NCT01052662|B4|Baseline|Total|Total of all reporting groups
245220|NCT01052662|B3|Baseline|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245221|NCT01052662|B2|Baseline|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245222|NCT01052662|B1|Baseline|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245223|NCT01052662|P3|Participant Flow|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245224|NCT01052662|P2|Participant Flow|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245225|NCT01052662|P1|Participant Flow|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245226|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245256|NCT01052428|P2|Participant Flow|Toprol-XL|
245257|NCT01052428|P1|Participant Flow|Placebo|
245258|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245259|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245260|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245227|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245228|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245229|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245230|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245231|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245232|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245233|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245234|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245235|NCT01052662|E3|Reported Event|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
245236|NCT01052662|E2|Reported Event|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
245261|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245262|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245237|NCT01052662|E1|Reported Event|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
245238|NCT01052545|B3|Baseline|Total|Total of all reporting groups
245239|NCT01052545|B2|Baseline|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
245240|NCT01052545|B1|Baseline|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
245241|NCT01052545|P2|Participant Flow|Arm 2- Control|This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
245242|NCT01052545|P1|Participant Flow|Arm 1- Intervention: Audit-Feedback|"Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.~Year 3: cased based, group audit and feedback delivered to providers, again based on this dignostic algorithm.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
245243|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
245244|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
245245|NCT01052545|O2|Outcome|Control Group|Cases of positive urine cultures on medicine and extended care wards at the control site
245246|NCT01052545|O1|Outcome|Intervention Group|Cases of positive urine cultures on medicine and extended care wards at the intervention site
245247|NCT01052545|O2|Outcome|Control Group|Medicine and extended care wards at control site
245248|NCT01052545|O1|Outcome|Intervention Group|Medicine and extended care wards at the intervention site
245249|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
245250|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
245251|NCT01052545|E2|Reported Event|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
245252|NCT01052545|E1|Reported Event|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
245253|NCT01052428|B3|Baseline|Total|Total of all reporting groups
245254|NCT01052428|B2|Baseline|Toprol-XL|
245263|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245264|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245265|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245266|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245267|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245268|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245269|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245270|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
245271|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
245272|NCT01052428|E2|Reported Event|Toprol-XL|
245273|NCT01052428|E1|Reported Event|Placebo|
245274|NCT01052272|B5|Baseline|Total|Total of all reporting groups
245275|NCT01052272|B4|Baseline|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245276|NCT01052272|B3|Baseline|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245277|NCT01052272|B2|Baseline|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245278|NCT01052272|B1|Baseline|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245279|NCT01052272|P4|Participant Flow|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245280|NCT01052272|P3|Participant Flow|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245281|NCT01052272|P2|Participant Flow|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245282|NCT01052272|P1|Participant Flow|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245283|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245284|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245285|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245286|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245287|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245288|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
246273|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
245289|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245290|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245291|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245292|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245293|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245294|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245295|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245296|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245297|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245298|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245299|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245300|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245301|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245302|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245303|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245304|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245305|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245306|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
246274|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
245307|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245308|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245309|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245310|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245311|NCT01052272|E4|Reported Event|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
245312|NCT01052272|E3|Reported Event|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
245313|NCT01052272|E2|Reported Event|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
245314|NCT01052272|E1|Reported Event|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
245315|NCT01052207|B3|Baseline|Total|Total of all reporting groups
245316|NCT01052207|B2|Baseline|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
245317|NCT01052207|B1|Baseline|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
245318|NCT01052207|P2|Participant Flow|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
245319|NCT01052207|P1|Participant Flow|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
245320|NCT01052207|O2|Outcome|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
245321|NCT01052207|O1|Outcome|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
245322|NCT01052207|E2|Reported Event|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
245357|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245323|NCT01052207|E1|Reported Event|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care"
245324|NCT01052116|B3|Baseline|Total|Total of all reporting groups
245325|NCT01052116|B2|Baseline|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
245326|NCT01052116|B1|Baseline|Placebo|"Matching placebo~Tablet twice a day"
245327|NCT01052116|P2|Participant Flow|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
245328|NCT01052116|P1|Participant Flow|Placebo|Matching placebo
245329|NCT01052116|O2|Outcome|Placebo|"Matching placebo~Tablet twice daily"
245330|NCT01052116|O1|Outcome|Soy Isoflavone|"Oral soy isoflavone supplement~tablet twice daily (100 mg/day)"
245331|NCT01052116|E2|Reported Event|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
245332|NCT01052116|E1|Reported Event|Placebo|"Matching placebo~Tablet twice a day"
245333|NCT01052077|B3|Baseline|Total|Total of all reporting groups
245334|NCT01052077|B2|Baseline|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245335|NCT01052077|B1|Baseline|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245336|NCT01052077|P4|Participant Flow|Phase A+|Participants who met the criteria for a response at the end of the 8 weeks prospective treatment phase received single-blind placebo + ADT for an additional 6 weeks in Phase A+ for a total of 14 weeks.
245337|NCT01052077|P3|Participant Flow|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245338|NCT01052077|P2|Participant Flow|Brexiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245339|NCT01052077|P1|Participant Flow|Phase A|Participants entered a single-blind prospective treatment phase during which they received single-blind placebo plus open-label commercially available ADT for 8 weeks at maximally tolerated doses.
245340|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245341|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245342|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245343|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245344|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245345|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245346|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245347|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245348|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245349|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245350|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245351|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245352|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245353|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245354|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245355|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245356|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
246275|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
249308|NCT01037218|B4|Baseline|Placebo|Placebo tablets
245358|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245359|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245360|NCT01052077|E2|Reported Event|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
245361|NCT01052077|E1|Reported Event|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
245362|NCT01052038|B4|Baseline|Total|Total of all reporting groups
245363|NCT01052038|B3|Baseline|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245364|NCT01052038|B2|Baseline|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245365|NCT01052038|B1|Baseline|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245366|NCT01052038|P3|Participant Flow|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245367|NCT01052038|P2|Participant Flow|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245368|NCT01052038|P1|Participant Flow|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245369|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245370|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245371|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245372|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245373|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245374|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245375|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245376|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245377|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245378|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245379|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245380|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245381|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245382|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245383|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245384|NCT01052038|E3|Reported Event|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
245385|NCT01052038|E2|Reported Event|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
245386|NCT01052038|E1|Reported Event|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
245387|NCT01051986|B3|Baseline|Total|Total of all reporting groups
245388|NCT01051986|B2|Baseline|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245389|NCT01051986|B1|Baseline|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245390|NCT01051986|P2|Participant Flow|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245391|NCT01051986|P1|Participant Flow|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245392|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245414|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
245393|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245394|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245395|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245396|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245397|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245398|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245399|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245400|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245401|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245402|NCT01051986|E2|Reported Event|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
245403|NCT01051986|E1|Reported Event|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
245404|NCT01051921|B1|Baseline|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
245405|NCT01051921|P1|Participant Flow|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
245406|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
245407|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
245408|NCT01051921|E1|Reported Event|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
245409|NCT01051856|B3|Baseline|Total|Total of all reporting groups
245410|NCT01051856|B2|Baseline|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
245411|NCT01051856|B1|Baseline|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
245412|NCT01051856|P2|Participant Flow|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
245413|NCT01051856|P1|Participant Flow|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
245415|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
245416|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
245417|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
245418|NCT01051856|E2|Reported Event|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
245419|NCT01051856|E1|Reported Event|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
245420|NCT01051817|B3|Baseline|Total|Total of all reporting groups
245421|NCT01051817|B2|Baseline|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
245422|NCT01051817|B1|Baseline|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
245423|NCT01051817|P2|Participant Flow|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
245424|NCT01051817|P1|Participant Flow|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
245425|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
245426|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
245427|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
245428|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
245429|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
245430|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
245431|NCT01051817|E2|Reported Event|AIN457 10mg/kg|AIN457 10mg/kg
245432|NCT01051817|E1|Reported Event|PLACEBO|PLACEBO
245433|NCT01051778|B3|Baseline|Total|Total of all reporting groups
245434|NCT01051778|B2|Baseline|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
245435|NCT01051778|B1|Baseline|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
245436|NCT01051778|P2|Participant Flow|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
245437|NCT01051778|P1|Participant Flow|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
245438|NCT01051778|O2|Outcome|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
245439|NCT01051778|O1|Outcome|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
245440|NCT01051778|E2|Reported Event|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
245441|NCT01051778|E1|Reported Event|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
245442|NCT01051739|B3|Baseline|Total|Total of all reporting groups
245443|NCT01051739|B2|Baseline|Group 2|normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
245444|NCT01051739|B1|Baseline|Group 1|glaucoma with mean deviation from 0 to -25 dB
245445|NCT01051739|P2|Participant Flow|Group 2|normal ocular healthy controls
245446|NCT01051739|P1|Participant Flow|Group 1|glaucoma patients
245447|NCT01051739|O2|Outcome|Control|Age-matched healthy observers were tested at baseline and then every six months for 4 years
245448|NCT01051739|O1|Outcome|Glaucoma|mean deviation 0 to -25 dB
245449|NCT01051739|E2|Reported Event|Group 2|"normal~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
245450|NCT01051739|E1|Reported Event|Group 1|"glaucoma~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
245451|NCT01051570|B1|Baseline|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
245452|NCT01051570|P1|Participant Flow|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
245453|NCT01051570|O1|Outcome|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
245454|NCT01051570|E1|Reported Event|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
245455|NCT01051557|B8|Baseline|Total|Total of all reporting groups
245456|NCT01051557|B7|Baseline|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245457|NCT01051557|B6|Baseline|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245458|NCT01051557|B5|Baseline|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245459|NCT01051557|B4|Baseline|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245460|NCT01051557|B3|Baseline|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245461|NCT01051557|B2|Baseline|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245462|NCT01051557|B1|Baseline|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245463|NCT01051557|P7|Participant Flow|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245464|NCT01051557|P6|Participant Flow|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245465|NCT01051557|P5|Participant Flow|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245466|NCT01051557|P4|Participant Flow|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245467|NCT01051557|P3|Participant Flow|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245468|NCT01051557|P2|Participant Flow|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245469|NCT01051557|P1|Participant Flow|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245470|NCT01051557|O1|Outcome|Treatment (Temsirolimus and Perifosine)|"PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery."
245471|NCT01051557|E7|Reported Event|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245472|NCT01051557|E6|Reported Event|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245473|NCT01051557|E5|Reported Event|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245474|NCT01051557|E4|Reported Event|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245475|NCT01051557|E3|Reported Event|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245476|NCT01051557|E2|Reported Event|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245477|NCT01051557|E1|Reported Event|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
245478|NCT01051466|B3|Baseline|Total|Total of all reporting groups
245479|NCT01051466|B2|Baseline|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245553|NCT01050998|B3|Baseline|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245480|NCT01051466|B1|Baseline|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245481|NCT01051466|P2|Participant Flow|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245482|NCT01051466|P1|Participant Flow|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245483|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245484|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III^UK). Healthy participants did not receive study drug.
245485|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245486|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245487|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245488|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245489|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245490|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245491|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
246276|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
245492|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245493|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245494|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245495|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245496|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245497|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245498|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245499|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245500|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245501|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245502|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245503|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245504|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
246501|NCT01048541|B1|Baseline|Entire Study|Includes groups randomized to standard catheter first and test catheter first
245505|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245506|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245507|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245508|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245509|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245510|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
245511|NCT01051466|E2|Reported Event|Healthy Participants|Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
245512|NCT01051466|E1|Reported Event|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.
245513|NCT01051440|B3|Baseline|Total|Total of all reporting groups
245514|NCT01051440|B2|Baseline|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245515|NCT01051440|B1|Baseline|Placebo|Subjects received matched placebo for lisdexamfetamine.
245516|NCT01051440|P2|Participant Flow|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245517|NCT01051440|P1|Participant Flow|Placebo|Subjects received matched placebo for lisdexamfetamine.
245518|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245519|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
245520|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245521|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
245522|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245523|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
245524|NCT01051440|E2|Reported Event|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
245525|NCT01051440|E1|Reported Event|Placebo|Subjects received matched placebo for lisdexamfetamine.
245526|NCT01051323|B3|Baseline|Total|Total of all reporting groups
245527|NCT01051323|B2|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245528|NCT01051323|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245554|NCT01050998|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246593|NCT01047839|B4|Baseline|Total|Total of all reporting groups
245529|NCT01051323|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245530|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245531|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245532|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245533|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245534|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245535|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245536|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245537|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245538|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245539|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245540|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245541|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245542|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245543|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245544|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245545|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245546|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245547|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245548|NCT01051323|E2|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245549|NCT01051323|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
245550|NCT01050998|B6|Baseline|Total|Total of all reporting groups
245551|NCT01050998|B5|Baseline|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245552|NCT01050998|B4|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245555|NCT01050998|B1|Baseline|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245556|NCT01050998|P5|Participant Flow|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245557|NCT01050998|P4|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245558|NCT01050998|P3|Participant Flow|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245559|NCT01050998|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245560|NCT01050998|P1|Participant Flow|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245561|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245562|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245563|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245564|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245565|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245566|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245567|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245568|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245569|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245570|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245571|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245572|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245573|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245574|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245575|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245576|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245577|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245578|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245579|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245580|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245581|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245582|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245583|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245584|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246594|NCT01047839|B3|Baseline|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
245585|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245586|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245587|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245588|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245589|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245590|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245591|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245592|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245593|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245594|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245595|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245596|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245597|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245598|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245599|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245600|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245601|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245602|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245603|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245604|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245605|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245606|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245607|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245608|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245609|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245610|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245611|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245612|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245613|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245614|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246595|NCT01047839|B2|Baseline|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
249309|NCT01037218|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
245615|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245616|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245617|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245618|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245619|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245620|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245621|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245622|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245623|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245624|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245625|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245626|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245627|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245628|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245629|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245630|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245631|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245632|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245633|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245634|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245635|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245636|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245637|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245638|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245639|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245640|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245641|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245642|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245643|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245644|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245645|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245646|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245647|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245648|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245649|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245650|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245651|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245652|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245653|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245654|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245655|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245656|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245657|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245658|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245659|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245660|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245661|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245662|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245663|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245664|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245665|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245666|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245667|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245668|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245669|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245670|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245671|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245672|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245673|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245674|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245675|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246092|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
245676|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245677|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245678|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245679|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245680|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245681|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245682|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245683|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245684|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245685|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245686|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245687|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245688|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245689|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245690|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245691|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245692|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245693|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245694|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245695|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245696|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245697|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245698|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245699|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245700|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245701|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245702|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245703|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245704|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245705|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246189|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study
245706|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245707|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245708|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245709|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245710|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245711|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245712|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245713|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245714|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245715|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245716|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245717|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245718|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245719|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245720|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245721|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245722|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245723|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245724|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245725|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245726|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245727|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245728|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245729|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245730|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245731|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245732|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245733|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245734|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245735|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246190|NCT01049581|E1|Reported Event|Effects of Pediatric Aquatic Therapy on Motor Performance|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I–IV,
245736|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245737|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245738|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245739|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245740|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245741|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245742|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245743|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245744|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245745|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245746|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245747|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245748|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245749|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245750|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245751|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245752|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245753|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245754|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245755|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245756|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245757|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245758|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245759|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245760|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245761|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245762|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245763|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245764|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245765|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246191|NCT01049503|B7|Baseline|Total|Total of all reporting groups
246596|NCT01047839|B1|Baseline|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
245766|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245767|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245768|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245769|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245770|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245771|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245772|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245773|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245774|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245775|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245776|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245777|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245778|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245779|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245780|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245781|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245782|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245783|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245784|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245785|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245786|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245787|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245788|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245789|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245790|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245791|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245792|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245793|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245794|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245795|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246192|NCT01049503|B6|Baseline|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
245796|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245797|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245798|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245799|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245800|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245801|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245802|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245803|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245804|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245805|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245806|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245807|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245808|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245809|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245810|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245811|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245812|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245813|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245814|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245815|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245816|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245817|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245818|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245819|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245820|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245821|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245822|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245823|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245824|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245825|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246193|NCT01049503|B5|Baseline|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
245826|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245827|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245828|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245829|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245830|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245831|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245832|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245833|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245834|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245835|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245836|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245837|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245838|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245839|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245840|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245841|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245842|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245843|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245844|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245845|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245846|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245847|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245848|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245849|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245850|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245851|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245852|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245853|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245854|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245855|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
246194|NCT01049503|B4|Baseline|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
245856|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245857|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245858|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245859|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245860|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245861|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245862|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245863|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245864|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245865|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245866|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245867|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245868|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245869|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245870|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245871|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245872|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245873|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245874|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245875|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245876|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245877|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245878|NCT01050998|E5|Reported Event|PLACEBO|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245879|NCT01050998|E4|Reported Event|CAM-3001 100 MG|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245880|NCT01050998|E3|Reported Event|CAM-3001 50 MG|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245881|NCT01050998|E2|Reported Event|CAM-3001 30 MG|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245882|NCT01050998|E1|Reported Event|CAM-3001 10 MG|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
245883|NCT01050946|B1|Baseline|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
246268|NCT01049360|P1|Participant Flow|Sequence 1|Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
246269|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
245884|NCT01050946|P1|Participant Flow|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245885|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245886|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245887|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245888|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245889|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245890|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245891|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant: Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245892|NCT01050946|E1|Reported Event|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
245893|NCT01050816|B1|Baseline|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245894|NCT01050816|P1|Participant Flow|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245950|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245895|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245896|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245897|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245898|NCT01050816|E1|Reported Event|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
245899|NCT01050790|B1|Baseline|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
245900|NCT01050790|P1|Participant Flow|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
245901|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245902|NCT01050790|O1|Outcome|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
245903|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245904|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245905|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245906|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245907|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245908|NCT01050790|E1|Reported Event|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
245909|NCT01050673|B3|Baseline|Total|Total of all reporting groups
245910|NCT01050673|B2|Baseline|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245911|NCT01050673|B1|Baseline|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245912|NCT01050673|P2|Participant Flow|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245913|NCT01050673|P1|Participant Flow|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245914|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245915|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245916|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245917|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245918|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245919|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245920|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245921|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245922|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245923|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245924|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245925|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245926|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245927|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245928|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245929|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245930|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245931|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245932|NCT01050673|E2|Reported Event|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
245933|NCT01050673|E1|Reported Event|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
245934|NCT01050660|B3|Baseline|Total|Total of all reporting groups
245935|NCT01050660|B2|Baseline|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245936|NCT01050660|B1|Baseline|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245937|NCT01050660|P2|Participant Flow|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245938|NCT01050660|P1|Participant Flow|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245939|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245940|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245941|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245942|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245943|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245944|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245945|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245946|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245947|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245948|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245949|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
246270|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
246271|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
245951|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245952|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245953|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245954|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245955|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245956|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245957|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245958|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245959|NCT01050660|E2|Reported Event|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
245960|NCT01050660|E1|Reported Event|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
245961|NCT01050634|B1|Baseline|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245962|NCT01050634|P1|Participant Flow|Aromasin (Exemestane)|The recommended dosage of exemestane was 25mg once a day.
245963|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245964|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245965|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245966|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245967|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
245968|NCT01050634|E1|Reported Event|Observational|
245969|NCT01050582|B3|Baseline|Total|Total of all reporting groups
245970|NCT01050582|B2|Baseline|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245971|NCT01050582|B1|Baseline|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245972|NCT01050582|P2|Participant Flow|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245973|NCT01050582|P1|Participant Flow|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245974|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245975|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245976|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245977|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245978|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245979|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245980|NCT01050582|E2|Reported Event|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
245981|NCT01050582|E1|Reported Event|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
245982|NCT01050569|B4|Baseline|Total|Total of all reporting groups
245983|NCT01050569|B3|Baseline|Nicotine Patch|21 mg nicotine patch
245984|NCT01050569|B2|Baseline|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
245985|NCT01050569|B1|Baseline|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
245986|NCT01050569|P3|Participant Flow|Nicotine Patch|Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.
245987|NCT01050569|P2|Participant Flow|VLNC Cigarette Plus Nicotine Patch|Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
245988|NCT01050569|P1|Participant Flow|VLNC Cigarette|Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
245989|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
245990|NCT01050569|O2|Outcome|VLNC Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
245991|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
245992|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
245993|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
245994|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
245995|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
245996|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
245997|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
245998|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
245999|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
246000|NCT01050569|O1|Outcome|VLNC Cigarette|VLNC Cigarettes: Cigarette where the tobacco contains <0.1 mg nicotine yield.
246001|NCT01050569|E3|Reported Event|Nicotine Patch|21 mg nicotine patch
246002|NCT01050569|E2|Reported Event|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
246003|NCT01050569|E1|Reported Event|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
246004|NCT01050543|B3|Baseline|Total|Total of all reporting groups
246005|NCT01050543|B2|Baseline|Neostigmine|neostigmine 50 mcg/kg
246006|NCT01050543|B1|Baseline|Sugammadex|sugammadex 2 mg/kg
246007|NCT01050543|P2|Participant Flow|Neostigmine|neostigmine 50 mcg/kg
246008|NCT01050543|P1|Participant Flow|Sugammadex|sugammadex 2 mg/kg
246009|NCT01050543|O2|Outcome|Neostigmine|neostigmine 50 mcg/kg
246010|NCT01050543|O1|Outcome|Sugammadex|sugammadex 2 mg/kg
246011|NCT01050543|E2|Reported Event|Neostigmine|neostigmine 50 mcg/kg
246012|NCT01050543|E1|Reported Event|Sugammadex|sugammadex 2 mg/kg
246013|NCT01050530|B3|Baseline|Total|Total of all reporting groups
246014|NCT01050530|B2|Baseline|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
246015|NCT01050530|B1|Baseline|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
246016|NCT01050530|P2|Participant Flow|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
246017|NCT01050530|P1|Participant Flow|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
246018|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
246019|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
246020|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
246021|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
246022|NCT01050530|E2|Reported Event|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
246023|NCT01050530|E1|Reported Event|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
246024|NCT01050257|B4|Baseline|Total|Total of all reporting groups
246025|NCT01050257|B3|Baseline|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246026|NCT01050257|B2|Baseline|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246027|NCT01050257|B1|Baseline|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246028|NCT01050257|P3|Participant Flow|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246061|NCT01050257|E3|Reported Event|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
249310|NCT01037218|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
246029|NCT01050257|P2|Participant Flow|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246030|NCT01050257|P1|Participant Flow|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246031|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246032|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246033|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246034|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246035|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246036|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246037|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246038|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246039|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246040|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246041|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246042|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246043|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246044|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246600|NCT01047839|O3|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
246045|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246046|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246047|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246048|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246049|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246050|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246051|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246052|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246053|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246054|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246055|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246056|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246057|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246058|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
246059|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246060|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246601|NCT01047839|O2|Outcome|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
246062|NCT01050257|E2|Reported Event|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246063|NCT01050257|E1|Reported Event|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
246064|NCT01050218|B1|Baseline|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
246065|NCT01050218|P1|Participant Flow|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
246066|NCT01050218|O1|Outcome|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
246067|NCT01050218|E1|Reported Event|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
246068|NCT01050153|B3|Baseline|Total|Total of all reporting groups
246069|NCT01050153|B2|Baseline|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246070|NCT01050153|B1|Baseline|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246071|NCT01050153|P2|Participant Flow|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246072|NCT01050153|P1|Participant Flow|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246073|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246074|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246075|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246076|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246077|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246078|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246079|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246080|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246081|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246082|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246083|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246084|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246085|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246086|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246087|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246088|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246089|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246090|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246091|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246093|NCT01050153|E2|Reported Event|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
246094|NCT01050153|E1|Reported Event|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
246095|NCT01050062|B3|Baseline|Total|Total of all reporting groups
246096|NCT01050062|B2|Baseline|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246097|NCT01050062|B1|Baseline|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246098|NCT01050062|P2|Participant Flow|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246099|NCT01050062|P1|Participant Flow|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246100|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246101|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246102|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246103|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246104|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246105|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246106|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246107|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246108|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246109|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246110|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246111|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246112|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246113|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246114|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246115|NCT01050062|E3|Reported Event|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
246116|NCT01050062|E2|Reported Event|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
246117|NCT01050062|E1|Reported Event|Combination Tablet Ap|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
246118|NCT01049984|B3|Baseline|Total|Total of all reporting groups
246119|NCT01049984|B2|Baseline|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246120|NCT01049984|B1|Baseline|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246121|NCT01049984|P2|Participant Flow|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246122|NCT01049984|P1|Participant Flow|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246123|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246124|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246125|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246126|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246127|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246128|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246129|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246130|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246131|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246132|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246133|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246134|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246135|NCT01049984|E2|Reported Event|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
246136|NCT01049984|E1|Reported Event|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
246137|NCT01049945|B3|Baseline|Total|Total of all reporting groups
246138|NCT01049945|B2|Baseline|Maximum Tolerated Dose, Dose Level 4|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
246139|NCT01049945|B1|Baseline|Phase I|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
246140|NCT01049945|P6|Participant Flow|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246141|NCT01049945|P5|Participant Flow|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246142|NCT01049945|P4|Participant Flow|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246143|NCT01049945|P3|Participant Flow|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246144|NCT01049945|P2|Participant Flow|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246145|NCT01049945|P1|Participant Flow|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246146|NCT01049945|O1|Outcome|Maximum Tolerated Dose, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
246147|NCT01049945|O5|Outcome|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246148|NCT01049945|O4|Outcome|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246149|NCT01049945|O3|Outcome|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246150|NCT01049945|O2|Outcome|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246151|NCT01049945|O1|Outcome|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246152|NCT01049945|E6|Reported Event|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246153|NCT01049945|E5|Reported Event|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246154|NCT01049945|E4|Reported Event|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246155|NCT01049945|E3|Reported Event|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246156|NCT01049945|E2|Reported Event|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246157|NCT01049945|E1|Reported Event|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
246158|NCT01049802|B3|Baseline|Total|Total of all reporting groups
246159|NCT01049802|B2|Baseline|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246160|NCT01049802|B1|Baseline|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246161|NCT01049802|P2|Participant Flow|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246162|NCT01049802|P1|Participant Flow|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246163|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246272|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
246164|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246165|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246166|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246167|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246168|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246169|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246170|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246171|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246172|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246173|NCT01049802|E2|Reported Event|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246174|NCT01049802|E1|Reported Event|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
246175|NCT01049776|B1|Baseline|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
246176|NCT01049776|P1|Participant Flow|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
246177|NCT01049776|O1|Outcome|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
246178|NCT01049776|E1|Reported Event|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
246179|NCT01049581|B3|Baseline|Total|Total of all reporting groups
246180|NCT01049581|B2|Baseline|Conventional Therapy Group|The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.
246181|NCT01049581|B1|Baseline|Pediatric Aquatic Therapy Group|The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.
246182|NCT01049581|P2|Participant Flow|Conventional Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
246183|NCT01049581|P1|Participant Flow|Pediatric Aquatic Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference
246184|NCT01049581|O2|Outcome|Conventional Therapy|Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate conventional therapy according preference
246185|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate pediatric aquatic therapy according preference
246186|NCT01049581|O2|Outcome|Conventional Therapy|14 children diagnosed as spastic type cerebral palsy participate conventional therapy and 13 children finish the study,each of them fulfill the the questionnaire before and after the intervention
246187|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic type cerebral palsy participate pediatric auqatic therapy and 11 children finish the study,each of them fulfill the the questionnaire before and after the intervention
246188|NCT01049581|O2|Outcome|Conventional Therapy|Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
249311|NCT01037218|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
246195|NCT01049503|B3|Baseline|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246196|NCT01049503|B2|Baseline|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246197|NCT01049503|B1|Baseline|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246198|NCT01049503|P6|Participant Flow|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246199|NCT01049503|P5|Participant Flow|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246200|NCT01049503|P4|Participant Flow|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246201|NCT01049503|P3|Participant Flow|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246202|NCT01049503|P2|Participant Flow|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246203|NCT01049503|P1|Participant Flow|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246204|NCT01049503|O3|Outcome|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246205|NCT01049503|O2|Outcome|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246206|NCT01049503|O1|Outcome|Caries-inactive 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246207|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246208|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246209|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246210|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246211|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246212|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246213|NCT01049503|O3|Outcome|1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
246214|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
246215|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
246216|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246217|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246218|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246219|NCT01049503|O3|Outcome|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246220|NCT01049503|O2|Outcome|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246221|NCT01049503|O1|Outcome|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246222|NCT01049503|O3|Outcome|1100 ppmF , pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
246223|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
246224|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
246225|NCT01049503|E6|Reported Event|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246226|NCT01049503|E5|Reported Event|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246227|NCT01049503|E4|Reported Event|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
246228|NCT01049503|E3|Reported Event|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246229|NCT01049503|E2|Reported Event|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246230|NCT01049503|E1|Reported Event|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
246231|NCT01049373|B3|Baseline|Total|Total of all reporting groups
246232|NCT01049373|B2|Baseline|Placebo Solution|10 drops t.i.d. for 15 weeks
246233|NCT01049373|B1|Baseline|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246234|NCT01049373|P2|Participant Flow|Placebo Solution|10 drops t.i.d. for 15 weeks
246235|NCT01049373|P1|Participant Flow|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246236|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
246237|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246238|NCT01049373|O2|Outcome|PLACEBO Solution|10 drops t.i.d. for 15 weeks
246239|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246240|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
246241|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246242|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
246243|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246244|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
246245|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246246|NCT01049373|E2|Reported Event|Placebo Solution|10 drops t.i.d. for 15 weeks
246247|NCT01049373|E1|Reported Event|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
246248|NCT01049360|B1|Baseline|Overall Population|Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
246249|NCT01049360|P20|Participant Flow|Sequence 20|Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
246250|NCT01049360|P19|Participant Flow|Sequence 19|Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
246251|NCT01049360|P18|Participant Flow|Sequence 18|Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
246252|NCT01049360|P17|Participant Flow|Sequence 17|Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
246253|NCT01049360|P16|Participant Flow|Sequence 16|Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
246254|NCT01049360|P15|Participant Flow|Sequence 15|Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
246255|NCT01049360|P14|Participant Flow|Sequence 14|Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
246256|NCT01049360|P13|Participant Flow|Sequence 13|Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
246257|NCT01049360|P12|Participant Flow|Sequence 12|Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
246258|NCT01049360|P11|Participant Flow|Sequence 11|Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
246259|NCT01049360|P10|Participant Flow|Sequence 10|Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
246260|NCT01049360|P9|Participant Flow|Sequence 9|Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
246261|NCT01049360|P8|Participant Flow|Sequence 8|Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
246262|NCT01049360|P7|Participant Flow|Sequence 7|Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
246263|NCT01049360|P6|Participant Flow|Sequence 6|Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
246264|NCT01049360|P5|Participant Flow|Sequence 5|Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
246265|NCT01049360|P4|Participant Flow|Sequence 4|Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
246266|NCT01049360|P3|Participant Flow|Sequence 3|Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
246267|NCT01049360|P2|Participant Flow|Sequence 2|Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
246277|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
246278|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
246279|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
246280|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
246281|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
246282|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
246283|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
246284|NCT01049360|E5|Reported Event|Placebo|Placebo twice-daily
246285|NCT01049360|E4|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
246286|NCT01049360|E3|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
246287|NCT01049360|E2|Reported Event|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
246288|NCT01049360|E1|Reported Event|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
246289|NCT01049308|B1|Baseline|Group 1|veteran population with documented heart failure
246290|NCT01049308|P1|Participant Flow|Heart Failure|veteran population with documented heart failure
246291|NCT01049308|O3|Outcome|Severe CI|veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
246292|NCT01049308|O2|Outcome|Mild CI|veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
246293|NCT01049308|O1|Outcome|No CI|veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
246294|NCT01049308|O1|Outcome|Heart Failure|veteran population with documented heart failure
246295|NCT01049308|E1|Reported Event|Group 1|veteran population with documented heart failure
246296|NCT01049243|B1|Baseline|Single Group|
246297|NCT01049243|P1|Participant Flow|Vanos|Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
246298|NCT01049243|O1|Outcome|Single Group|
246299|NCT01049243|E1|Reported Event|Single Group|
246300|NCT01049217|B3|Baseline|Total|Total of all reporting groups
246301|NCT01049217|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246302|NCT01049217|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246303|NCT01049217|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246304|NCT01049217|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246305|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246382|NCT01049009|E2|Reported Event|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
246383|NCT01049009|E1|Reported Event|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
246306|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246307|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246308|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246309|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246310|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246311|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246312|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246313|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246314|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246315|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246384|NCT01048944|B5|Baseline|Total|Total of all reporting groups
246385|NCT01048944|B4|Baseline|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
246602|NCT01047839|O1|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
246316|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246317|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246318|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246319|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246320|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246321|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246322|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246323|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246324|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246325|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246386|NCT01048944|B3|Baseline|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
246326|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246327|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246328|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246329|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246330|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246331|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246332|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246333|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246334|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246335|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246387|NCT01048944|B2|Baseline|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
246597|NCT01047839|P3|Participant Flow|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
246336|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246337|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246338|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246339|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246340|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246341|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246342|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246343|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246344|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246345|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246388|NCT01048944|B1|Baseline|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
246389|NCT01048944|P4|Participant Flow|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
246346|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246347|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246348|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246349|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246350|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246351|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246352|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246353|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246354|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246355|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246390|NCT01048944|P3|Participant Flow|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
246356|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246357|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246358|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246359|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246360|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246361|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246362|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246363|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246364|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246365|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246391|NCT01048944|P2|Participant Flow|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
246598|NCT01047839|P2|Participant Flow|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
246366|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246367|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246368|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246369|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246370|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246371|NCT01049217|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246372|NCT01049217|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
246373|NCT01049009|B3|Baseline|Total|Total of all reporting groups
246374|NCT01049009|B2|Baseline|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
246375|NCT01049009|B1|Baseline|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
246376|NCT01049009|P2|Participant Flow|Metoprolol XL/Nebivolol|Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
246377|NCT01049009|P1|Participant Flow|Nebivolol/Metoprolol XL|Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
246378|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
246379|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
246380|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
246381|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
246392|NCT01048944|P1|Participant Flow|Bupropion Sustained Release (SR)|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
246393|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
246394|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
246395|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
246396|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
246397|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
246398|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
246399|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
246400|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
246401|NCT01048944|E4|Reported Event|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
246402|NCT01048944|E3|Reported Event|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
246403|NCT01048944|E2|Reported Event|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
246404|NCT01048944|E1|Reported Event|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down."
246405|NCT01048879|B4|Baseline|Total|Total of all reporting groups
246406|NCT01048879|B3|Baseline|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
246407|NCT01048879|B2|Baseline|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
246408|NCT01048879|B1|Baseline|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
246409|NCT01048879|P3|Participant Flow|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
246410|NCT01048879|P2|Participant Flow|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
246411|NCT01048879|P1|Participant Flow|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
246412|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
246413|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
246414|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
246415|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
246416|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
246417|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
246418|NCT01048879|E3|Reported Event|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
246419|NCT01048879|E2|Reported Event|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
246420|NCT01048879|E1|Reported Event|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
246421|NCT01048788|B4|Baseline|Total|Total of all reporting groups
246422|NCT01048788|B3|Baseline|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
246423|NCT01048788|B2|Baseline|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
246424|NCT01048788|B1|Baseline|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
246425|NCT01048788|P3|Participant Flow|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
246426|NCT01048788|P2|Participant Flow|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
246427|NCT01048788|P1|Participant Flow|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
246428|NCT01048788|O3|Outcome|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
246429|NCT01048788|O2|Outcome|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
246430|NCT01048788|O1|Outcome|Discontitued/Terminated Before Day 8|Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
246431|NCT01048788|E3|Reported Event|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
246432|NCT01048788|E2|Reported Event|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
246433|NCT01048788|E1|Reported Event|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
246434|NCT01048723|B1|Baseline|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246435|NCT01048723|P1|Participant Flow|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246436|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246491|NCT01048593|B1|Baseline|Dose 1|114ug dose group
246492|NCT01048593|P3|Participant Flow|Dose 3|684ug dose group
246437|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246438|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246439|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246440|NCT01048723|E1|Reported Event|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
246441|NCT01048697|B1|Baseline|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
246442|NCT01048697|P1|Participant Flow|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
246443|NCT01048697|O1|Outcome|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
246444|NCT01048697|E1|Reported Event|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
246445|NCT01048671|B4|Baseline|Total|Total of all reporting groups
246446|NCT01048671|B3|Baseline|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
246447|NCT01048671|B2|Baseline|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
246448|NCT01048671|B1|Baseline|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246449|NCT01048671|P3|Participant Flow|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246450|NCT01048671|P2|Participant Flow|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246451|NCT01048671|P1|Participant Flow|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246452|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246453|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246454|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246455|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246456|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246457|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246458|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246459|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246460|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246461|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246462|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246463|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246464|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246465|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246466|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246467|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246468|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246469|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246470|NCT01048671|E1|Reported Event|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
246471|NCT01048606|B5|Baseline|Total|Total of all reporting groups
246472|NCT01048606|B4|Baseline|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
246473|NCT01048606|B3|Baseline|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246474|NCT01048606|B2|Baseline|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
246475|NCT01048606|B1|Baseline|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246476|NCT01048606|P4|Participant Flow|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
246493|NCT01048593|P2|Participant Flow|Dose 2|513ug dose group
246494|NCT01048593|P1|Participant Flow|Dose 1|114ug dose group
246477|NCT01048606|P3|Participant Flow|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246478|NCT01048606|P2|Participant Flow|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
246479|NCT01048606|P1|Participant Flow|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246480|NCT01048606|O4|Outcome|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
246481|NCT01048606|O3|Outcome|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246482|NCT01048606|O2|Outcome|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
246483|NCT01048606|O1|Outcome|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246484|NCT01048606|E4|Reported Event|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
246485|NCT01048606|E3|Reported Event|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246486|NCT01048606|E2|Reported Event|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
246487|NCT01048606|E1|Reported Event|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
246488|NCT01048593|B4|Baseline|Total|Total of all reporting groups
246489|NCT01048593|B3|Baseline|Dose 3|684ug dose group
246490|NCT01048593|B2|Baseline|Dose 2|513ug dose group
246502|NCT01048541|P2|Participant Flow|BA: First Standard Catheter Then Test Catheter|Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
246503|NCT01048541|P1|Participant Flow|AB: First Test Catheter Then Standard Catheter|Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period
246504|NCT01048541|O2|Outcome|Standard Catheter|Standard catheter (SpediCath straight)
246505|NCT01048541|O1|Outcome|Test Catheter|Test catheter (SpeediCath Compact Male)
246506|NCT01048541|E2|Reported Event|Standard Catheter|Standard catheter (SpediCath straight)
246507|NCT01048541|E1|Reported Event|Test Catheter|Test catheter (SpeediCath Compact Male)
246508|NCT01048502|B5|Baseline|Total|Total of all reporting groups
246509|NCT01048502|B4|Baseline|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246510|NCT01048502|B3|Baseline|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246511|NCT01048502|B2|Baseline|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
246512|NCT01048502|B1|Baseline|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
246513|NCT01048502|P4|Participant Flow|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246514|NCT01048502|P3|Participant Flow|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246515|NCT01048502|P2|Participant Flow|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
246516|NCT01048502|P1|Participant Flow|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
246517|NCT01048502|O2|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
246518|NCT01048502|O1|Outcome|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
246519|NCT01048502|O3|Outcome|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246520|NCT01048502|O2|Outcome|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246521|NCT01048502|O1|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
246522|NCT01048502|E4|Reported Event|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246523|NCT01048502|E3|Reported Event|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
246524|NCT01048502|E2|Reported Event|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
246525|NCT01048502|E1|Reported Event|Tricor (145 mg/Day)|"Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
246526|NCT01048424|B3|Baseline|Total|Total of all reporting groups
246603|NCT01047839|E3|Reported Event|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
246527|NCT01048424|B2|Baseline|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246528|NCT01048424|B1|Baseline|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246529|NCT01048424|P2|Participant Flow|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246530|NCT01048424|P1|Participant Flow|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246531|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246532|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246533|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246534|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246535|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246536|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246537|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246538|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246539|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246540|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246541|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246542|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246543|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246544|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246545|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246546|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246547|NCT01048424|O2|Outcome|Control|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246548|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246549|NCT01048424|E2|Reported Event|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246550|NCT01048424|E1|Reported Event|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
246551|NCT01048333|B1|Baseline|Entire Study Population|Includes all 3 arms : Formoterol, Salmeterol and Placebo.
246552|NCT01048333|P6|Participant Flow|Placebo, Then Salmeterol, Then Formoterol|Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
246553|NCT01048333|P5|Participant Flow|Salmeterol, Then Formoterol, Then Placebo|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
246554|NCT01048333|P4|Participant Flow|Formoterol, Then Placebo, Then Salmeterol|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
246599|NCT01047839|P1|Participant Flow|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
246555|NCT01048333|P3|Participant Flow|Placebo, Then Formoterol, Then Salmeterol|Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
246556|NCT01048333|P2|Participant Flow|Salmeterol, Then Palcebo, Then Formoterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
246557|NCT01048333|P1|Participant Flow|Formoterol, Then Salmeterol, Then Placebo|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
246558|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246559|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246560|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
246561|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246562|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246563|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
246564|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246565|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246566|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
246567|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246568|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246569|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
246570|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246571|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246572|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
246573|NCT01048333|E3|Reported Event|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
246574|NCT01048333|E2|Reported Event|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
246575|NCT01048333|E1|Reported Event|Formoterol|Formoterol Turbuhaler 9 mcg
246576|NCT01048125|B3|Baseline|Total|Total of all reporting groups
246577|NCT01048125|B2|Baseline|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246578|NCT01048125|B1|Baseline|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246579|NCT01048125|P2|Participant Flow|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
246580|NCT01048125|P1|Participant Flow|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246581|NCT01048125|O2|Outcome|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
246582|NCT01048125|O1|Outcome|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246583|NCT01048125|E2|Reported Event|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246584|NCT01048125|E1|Reported Event|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
246585|NCT01048099|B1|Baseline|Patients Treated|Patients who received study treatment
246586|NCT01048099|P1|Participant Flow|All Patients|
246587|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
246588|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
246589|NCT01048099|O1|Outcome|All Patients|
246590|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
246591|NCT01048099|O1|Outcome|All Patients Evaluated by PRO Onc Assay|
246592|NCT01048099|E1|Reported Event|All Treated Patients|Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
246604|NCT01047839|E2|Reported Event|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
246605|NCT01047839|E1|Reported Event|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
246606|NCT01047709|B1|Baseline|All Study Participants|All study participants.
246607|NCT01047709|P2|Participant Flow|Control Night First, Then Positional Therapy Night|Position ad lib for the first night, then one night of avoidance of supine positioning.
246608|NCT01047709|P1|Participant Flow|Positional Therapy Night First, Then Control Night|Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.
246609|NCT01047709|O2|Outcome|Control Night|Position ad lib
246610|NCT01047709|O1|Outcome|Positional Therapy Night|Avoidance of supine positioning.
246611|NCT01047709|E2|Reported Event|Control Night|Position ad lib
246612|NCT01047709|E1|Reported Event|Positional Therapy Night|Avoidance of supine positioning.
246613|NCT01047553|B3|Baseline|Total|Total of all reporting groups
246614|NCT01047553|B2|Baseline|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246615|NCT01047553|B1|Baseline|Formoterol|Formoterol 9 μg twice daily
246616|NCT01047553|P2|Participant Flow|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246617|NCT01047553|P1|Participant Flow|Formoterol|Formoterol 9 μg twice daily
246618|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246619|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246620|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246621|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246622|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246623|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246624|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246625|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246626|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246627|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246628|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246629|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246630|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246631|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246632|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246633|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246634|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246635|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246636|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246637|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246638|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246639|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246640|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246641|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246642|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246643|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246644|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246645|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246646|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246647|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246648|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246649|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246650|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246651|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246652|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246653|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246654|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246655|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246656|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246657|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246658|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246659|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246660|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246661|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246662|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246663|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246664|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246665|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246666|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246667|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246668|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246669|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246670|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246671|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246672|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246673|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246674|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246675|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246676|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246677|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246678|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246679|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246680|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246681|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246682|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246683|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246684|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246685|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246686|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246687|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246688|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246689|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246690|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246691|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246692|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246693|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246694|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246695|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
246696|NCT01047553|E2|Reported Event|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
246697|NCT01047553|E1|Reported Event|Formoterol|Formoterol 9 μg twice daily
246698|NCT01047527|B4|Baseline|Total|Total of all reporting groups
246699|NCT01047527|B3|Baseline|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246700|NCT01047527|B2|Baseline|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246701|NCT01047527|B1|Baseline|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246702|NCT01047527|P3|Participant Flow|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246703|NCT01047527|P2|Participant Flow|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246704|NCT01047527|P1|Participant Flow|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246705|NCT01047527|O2|Outcome|Extended + Maintenance|
246706|NCT01047527|O1|Outcome|Standard|
246707|NCT01047527|O2|Outcome|Maintenance|Participants on 52 weeks of therapy
246708|NCT01047527|O1|Outcome|Standard + Extended|participants on standard or extended therapy
246709|NCT01047527|E3|Reported Event|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246710|NCT01047527|E2|Reported Event|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246711|NCT01047527|E1|Reported Event|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
246712|NCT01047475|B3|Baseline|Total|Total of all reporting groups
246713|NCT01047475|B2|Baseline|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
246714|NCT01047475|B1|Baseline|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
246715|NCT01047475|P2|Participant Flow|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
246716|NCT01047475|P1|Participant Flow|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
246717|NCT01047475|O2|Outcome|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
246718|NCT01047475|O1|Outcome|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
246719|NCT01047475|E2|Reported Event|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
246720|NCT01047475|E1|Reported Event|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
246721|NCT01047436|B3|Baseline|Total|Total of all reporting groups
246722|NCT01047436|B2|Baseline|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246723|NCT01047436|B1|Baseline|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246724|NCT01047436|P2|Participant Flow|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246725|NCT01047436|P1|Participant Flow|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246726|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246727|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246728|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246729|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246730|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246731|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246732|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246733|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246734|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246735|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246736|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246737|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246738|NCT01047436|E2|Reported Event|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
246739|NCT01047436|E1|Reported Event|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
246740|NCT01047358|B1|Baseline|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246741|NCT01047358|P1|Participant Flow|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246742|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246743|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246744|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246745|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246746|NCT01047358|E1|Reported Event|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
246747|NCT01047345|B3|Baseline|Total|Total of all reporting groups
246748|NCT01047345|B2|Baseline|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246749|NCT01047345|B1|Baseline|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246750|NCT01047345|P3|Participant Flow|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
246751|NCT01047345|P2|Participant Flow|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246752|NCT01047345|P1|Participant Flow|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246753|NCT01047345|O1|Outcome|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
246754|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246755|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246788|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
247555|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
246756|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246757|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246758|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246759|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246760|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246761|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246762|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246763|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246764|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246765|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246766|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246767|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246768|NCT01047345|E3|Reported Event|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
246769|NCT01047345|E2|Reported Event|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
246770|NCT01047345|E1|Reported Event|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
246771|NCT01047306|B3|Baseline|Total|Total of all reporting groups
246772|NCT01047306|B2|Baseline|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246773|NCT01047306|B1|Baseline|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246774|NCT01047306|P2|Participant Flow|Children ≥ 6 Years Old|Children ≥ 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
246775|NCT01047306|P1|Participant Flow|Children < 6 Years Old|Children ≥1 to < 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
246776|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246777|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246778|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246779|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246780|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246781|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246782|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246783|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246784|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246785|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246786|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246787|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246789|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246790|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246791|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246792|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246793|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246794|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246795|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246796|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246797|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246798|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246799|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246800|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246801|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246802|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246803|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246804|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246805|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246806|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246807|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246808|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246809|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246810|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246811|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246812|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246813|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246814|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246815|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246816|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246817|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246818|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246819|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246820|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246821|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246822|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246823|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246824|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246825|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246826|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246827|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246828|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246829|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246830|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246831|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246832|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246833|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246834|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246835|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246836|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246837|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246838|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246839|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246840|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246841|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246842|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246843|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246844|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246845|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246846|NCT01047306|E2|Reported Event|Children ≥ 6 Years|Patients ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246847|NCT01047306|E1|Reported Event|Children < 6 Years|Patients ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
246848|NCT01047241|B1|Baseline|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
246849|NCT01047241|P1|Participant Flow|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
246850|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
246851|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
246852|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
246853|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing sufentanil/ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
246854|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
246855|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
246856|NCT01047241|E1|Reported Event|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
246857|NCT01047189|B3|Baseline|Total|Total of all reporting groups
246858|NCT01047189|B2|Baseline|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
246859|NCT01047189|B1|Baseline|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
246860|NCT01047189|P2|Participant Flow|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
246861|NCT01047189|P1|Participant Flow|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
246862|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
246863|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
246864|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
246865|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
246866|NCT01047189|E2|Reported Event|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
246867|NCT01047189|E1|Reported Event|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
246868|NCT01046903|B1|Baseline|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246869|NCT01046903|P1|Participant Flow|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
249312|NCT01037218|P4|Participant Flow|Placebo|Placebo tablets
246870|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246871|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246872|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246873|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246874|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246875|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246876|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246877|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246878|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246879|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246880|NCT01046903|E1|Reported Event|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
246881|NCT01046877|B1|Baseline|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246882|NCT01046877|P1|Participant Flow|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246883|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246884|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246885|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246886|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246887|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246888|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246889|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246890|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246891|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246892|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246893|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246894|NCT01046877|E1|Reported Event|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
246895|NCT01046695|B3|Baseline|Total|Total of all reporting groups
246896|NCT01046695|B2|Baseline|Control Arm|This arm will have standard care for their post operative pain control.
246897|NCT01046695|B1|Baseline|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
246898|NCT01046695|P2|Participant Flow|TENS Unit|Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
246899|NCT01046695|P1|Participant Flow|Control Arm|Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
246900|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
246901|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
246902|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
246903|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
246904|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
246905|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
246906|NCT01046695|E2|Reported Event|Control Arm|This arm will have standard care for their post operative pain control.
246907|NCT01046695|E1|Reported Event|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
246908|NCT01046682|B3|Baseline|Total|Total of all reporting groups
246909|NCT01046682|B2|Baseline|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
246910|NCT01046682|B1|Baseline|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
246911|NCT01046682|P2|Participant Flow|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
246912|NCT01046682|P1|Participant Flow|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
246913|NCT01046682|O2|Outcome|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
246914|NCT01046682|O1|Outcome|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
246915|NCT01046682|E2|Reported Event|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
246916|NCT01046682|E1|Reported Event|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
246917|NCT01046643|B3|Baseline|Total|Total of all reporting groups
246918|NCT01046643|B2|Baseline|Progesterone and Placebo|"Progesterone treatment (P10)~Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
246919|NCT01046643|B1|Baseline|Estrogen and Placebo|"Estrogen treatment with Estradiol (E2)~Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
246920|NCT01046643|P4|Participant Flow|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
247556|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
246921|NCT01046643|P3|Participant Flow|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
246922|NCT01046643|P2|Participant Flow|Progesterone Followed by Placebo|"Progesterone (P10) treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
246923|NCT01046643|P1|Participant Flow|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day"
246924|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246925|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246926|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
246927|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
246928|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246929|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246930|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
246931|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
246932|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246933|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246934|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
246935|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
246936|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246937|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
246938|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
246939|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
246940|NCT01046643|E4|Reported Event|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
246941|NCT01046643|E3|Reported Event|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) capsule once a day, at the same time each day, for 90 days.
246942|NCT01046643|E2|Reported Event|Progesterone Followed by Placebo|"Progesterone treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
246943|NCT01046643|E1|Reported Event|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day."
246944|NCT01046565|B1|Baseline|Differin® Lotion 0.1% and Differin Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246945|NCT01046565|P1|Participant Flow|Differin® Lotion 0.1% and Differin® Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246946|NCT01046565|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
246947|NCT01046565|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks
246948|NCT01046565|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
246949|NCT01046565|O2|Outcome|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246950|NCT01046565|O1|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246951|NCT01046565|E2|Reported Event|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246952|NCT01046565|E1|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
246953|NCT01046396|B1|Baseline|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
246954|NCT01046396|P1|Participant Flow|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
246955|NCT01046396|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
246956|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
246957|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
246958|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
246959|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
246960|NCT01046396|E2|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
246961|NCT01046396|E1|Reported Event|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
246962|NCT01046253|B3|Baseline|Total|Total of all reporting groups
246963|NCT01046253|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
246964|NCT01046253|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
246965|NCT01046253|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
246966|NCT01046253|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
246967|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
246968|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
246969|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
246970|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
246971|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
246972|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
246973|NCT01046253|E2|Reported Event|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
246974|NCT01046253|E1|Reported Event|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
246975|NCT01046136|B3|Baseline|Total|Total of all reporting groups
246976|NCT01046136|B2|Baseline|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
246977|NCT01046136|B1|Baseline|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
246978|NCT01046136|P2|Participant Flow|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
246979|NCT01046136|P1|Participant Flow|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
246980|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
246981|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
246982|NCT01046136|O2|Outcome|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
246983|NCT01046136|O1|Outcome|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
246984|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
246985|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
246986|NCT01046136|E2|Reported Event|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
246987|NCT01046136|E1|Reported Event|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
246988|NCT01046110|B3|Baseline|Total|Total of all reporting groups
246989|NCT01046110|B2|Baseline|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
246990|NCT01046110|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
246991|NCT01046110|P2|Participant Flow|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
246992|NCT01046110|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
246993|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
246994|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
246995|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
247258|NCT01045187|O1|Outcome|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
246996|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
246997|NCT01046110|E2|Reported Event|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
246998|NCT01046110|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
246999|NCT01046084|B3|Baseline|Total|Total of all reporting groups
247000|NCT01046084|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
247001|NCT01046084|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
247002|NCT01046084|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
247003|NCT01046084|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
247004|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
247005|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
247006|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
247007|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
247008|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
247009|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
247010|NCT01046084|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
247011|NCT01046084|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
247012|NCT01045993|B5|Baseline|Total|Total of all reporting groups
247013|NCT01045993|B4|Baseline|Oral Placebo|Oral Placebo matching Oral IBU.
247014|NCT01045993|B3|Baseline|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247015|NCT01045993|B2|Baseline|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247016|NCT01045993|B1|Baseline|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247017|NCT01045993|P4|Participant Flow|Oral Placebo|Oral Placebo matching Oral IBU.
247018|NCT01045993|P3|Participant Flow|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247019|NCT01045993|P2|Participant Flow|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247020|NCT01045993|P1|Participant Flow|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247021|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247022|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247023|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247024|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247025|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247026|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247027|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247028|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247029|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247030|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247031|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247032|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247033|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247034|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247035|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247036|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247037|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247038|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247039|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247040|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247041|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247042|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247043|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247044|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247045|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247046|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247047|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247048|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247049|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247050|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247051|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247052|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247053|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247054|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247055|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247056|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247057|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247058|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247059|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247060|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247061|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247062|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247063|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247064|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247065|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247066|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247067|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247068|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247069|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247070|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247071|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247072|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247073|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247074|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247075|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247076|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247077|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247078|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247079|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247080|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247081|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247082|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247083|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247084|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247085|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
247086|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247087|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247088|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247089|NCT01045993|E4|Reported Event|Oral Placebo|Oral Placebo matching Oral IBU.
247090|NCT01045993|E3|Reported Event|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
247091|NCT01045993|E2|Reported Event|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
247092|NCT01045993|E1|Reported Event|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
247093|NCT01045967|B3|Baseline|Total|Total of all reporting groups
247094|NCT01045967|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
247095|NCT01045967|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
247096|NCT01045967|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
247097|NCT01045967|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
247098|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
247099|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
247100|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
247101|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
247102|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
247103|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
247104|NCT01045967|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
247105|NCT01045967|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
247106|NCT01045798|B3|Baseline|Total|Total of all reporting groups
247107|NCT01045798|B2|Baseline|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
247108|NCT01045798|B1|Baseline|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
247109|NCT01045798|P2|Participant Flow|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
247110|NCT01045798|P1|Participant Flow|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
247111|NCT01045798|O2|Outcome|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
247112|NCT01045798|O1|Outcome|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
247113|NCT01045798|E2|Reported Event|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
247114|NCT01045798|E1|Reported Event|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
247115|NCT01045707|B3|Baseline|Total|Total of all reporting groups
247116|NCT01045707|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247117|NCT01045707|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247118|NCT01045707|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247119|NCT01045707|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247120|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
251550|NCT01029886|B3|Baseline|Total|Total of all reporting groups
247121|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247122|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247123|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247124|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247125|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247126|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247127|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247128|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247129|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247130|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247131|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247132|NCT01045707|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
247133|NCT01045707|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
247134|NCT01045551|B1|Baseline|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247135|NCT01045551|P1|Participant Flow|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247136|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247137|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247138|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247139|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247140|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
247141|NCT01045551|E1|Reported Event|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks~The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE’s were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation."
247142|NCT01045447|B3|Baseline|Total|Total of all reporting groups
247143|NCT01045447|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
247144|NCT01045447|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
247145|NCT01045447|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
247146|NCT01045447|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
247147|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
247148|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
247149|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
247150|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
247151|NCT01045447|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
247152|NCT01045447|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
247153|NCT01045421|B7|Baseline|Total|Total of all reporting groups
247154|NCT01045421|B6|Baseline|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247155|NCT01045421|B5|Baseline|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247156|NCT01045421|B4|Baseline|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247157|NCT01045421|B3|Baseline|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247158|NCT01045421|B2|Baseline|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247159|NCT01045421|B1|Baseline|Phase 1: MLN8237- All Participants|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose-escalation or pancreatic cancer cohort during Phase 1 portion of the study.
247160|NCT01045421|P11|Participant Flow|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247161|NCT01045421|P10|Participant Flow|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247162|NCT01045421|P9|Participant Flow|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247163|NCT01045421|P8|Participant Flow|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247164|NCT01045421|P7|Participant Flow|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247165|NCT01045421|P6|Participant Flow|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
247166|NCT01045421|P5|Participant Flow|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247167|NCT01045421|P4|Participant Flow|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247168|NCT01045421|P3|Participant Flow|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247169|NCT01045421|P2|Participant Flow|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247170|NCT01045421|P1|Participant Flow|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247171|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247172|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247173|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247174|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247175|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247176|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247177|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247178|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247179|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247180|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247181|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247182|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247183|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247184|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247185|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247186|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247187|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247188|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247189|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247190|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247191|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247192|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247193|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247194|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247195|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247196|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247197|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247198|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247199|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247200|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247201|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247202|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247203|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247204|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247205|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247206|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247207|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
247208|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247209|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247210|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247211|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247212|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247213|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247214|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247215|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247216|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247217|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247218|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247219|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247259|NCT01045187|E1|Reported Event|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
247260|NCT01045161|B4|Baseline|Total|Total of all reporting groups
247557|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
247220|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247221|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247222|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247223|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247224|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247225|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247226|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247227|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247228|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247229|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247230|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247231|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247232|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247233|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247234|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247235|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247236|NCT01045421|O6|Outcome|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
253896|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
247237|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247238|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247239|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247240|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247241|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
247242|NCT01045421|E7|Reported Event|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
247243|NCT01045421|E6|Reported Event|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
247244|NCT01045421|E5|Reported Event|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
247245|NCT01045421|E4|Reported Event|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
247246|NCT01045421|E3|Reported Event|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
247247|NCT01045421|E2|Reported Event|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
247248|NCT01045421|E1|Reported Event|Phase 1: MLN8237- Dose Escalation|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose escalation cohort during Phase 1 portion of the study.
247249|NCT01045265|B1|Baseline|Men on Raltegravir|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
247250|NCT01045265|P1|Participant Flow|Men on Raltegravir|HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
247251|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
247252|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
247253|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
247254|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
247255|NCT01045265|E1|Reported Event|Men on Raltegravir|HIV-infected men receiving chronic therapy with raltegravir 400 mg per day as part of antiretroviral regimen.
247256|NCT01045187|B1|Baseline|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
247257|NCT01045187|P1|Participant Flow|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
247261|NCT01045161|B3|Baseline|Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B|"Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks."
247262|NCT01045161|B2|Baseline|Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B|"Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks."
247263|NCT01045161|B1|Baseline|Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B|"Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks."
247264|NCT01045161|P3|Participant Flow|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks
247265|NCT01045161|P2|Participant Flow|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
247266|NCT01045161|P1|Participant Flow|Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
247267|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks
247268|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
247269|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
247270|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks
247271|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
247272|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
247273|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
247274|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
247275|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
247276|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
247277|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
247278|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
247279|NCT01045161|E6|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B|After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
247280|NCT01045161|E5|Reported Event|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B|Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
247281|NCT01045161|E4|Reported Event|Placebo to Aclidinium Bromide 400 μg - Part B|After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
247282|NCT01045161|E3|Reported Event|Aclidinium Bromide 400 μg - Part A|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.
247283|NCT01045161|E2|Reported Event|Aclidinium Bromide 200 μg - Part A|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.
247284|NCT01045161|E1|Reported Event|Placebo - Part A|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.
247285|NCT01045122|B1|Baseline|Propofol vs Dexmedetomidine|We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
247286|NCT01045122|P2|Participant Flow|Dexmedetomidine First|Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
247287|NCT01045122|P1|Participant Flow|Propofol First|Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine
247288|NCT01045122|O2|Outcome|Dexmedetomidine|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
247289|NCT01045122|O1|Outcome|Propofol|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
247408|NCT01044693|P1|Participant Flow|Placebo Then Metoprolol Then Sildenafil Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247290|NCT01045122|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.~Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr."
247291|NCT01045122|E1|Reported Event|Propofol|"Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.~Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained."
247292|NCT01045096|B4|Baseline|Total|Total of all reporting groups
247293|NCT01045096|B3|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247294|NCT01045096|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247295|NCT01045096|B1|Baseline|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247296|NCT01045096|P3|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247297|NCT01045096|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247298|NCT01045096|P1|Participant Flow|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247299|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247300|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247301|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247302|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247303|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247304|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247305|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247306|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247307|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247308|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247309|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247310|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247311|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247312|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247313|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247314|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247315|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247316|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247317|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247318|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247319|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247320|NCT01045096|E3|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
247321|NCT01045096|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
247322|NCT01045096|E1|Reported Event|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
247323|NCT01045057|B1|Baseline|Provox Vega Puncture Set|Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set
247324|NCT01045057|P1|Participant Flow|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Vega Puncture Set
247325|NCT01045057|O1|Outcome|Secondary Puncture|Patients who had a secondary puncture
247326|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
247327|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
247328|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
247329|NCT01045057|E1|Reported Event|Provox Vega Puncture Set|Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
247330|NCT01045031|B3|Baseline|Total|Total of all reporting groups
247331|NCT01045031|B2|Baseline|Controls|The control group was matched according to age, sex and years of education.
247558|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
247332|NCT01045031|B1|Baseline|Marathon Athletes|Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)
247333|NCT01045031|P2|Participant Flow|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
247334|NCT01045031|P1|Participant Flow|Controls|The control group was matched according to age, sex and years of education.
247335|NCT01045031|O2|Outcome|Marathon Athletes|Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.
247336|NCT01045031|O1|Outcome|Controls|Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper (“Krone”) and one in an Austrian bicyclist journal (“Bicyclist Sports”). The controls were matched according to age, sex and years of education
247337|NCT01045031|O2|Outcome|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
247338|NCT01045031|O1|Outcome|Controls|The control group was matched according to age, sex and years of education.
247339|NCT01045031|O2|Outcome|Controls|Brain-derived Neurotrophic Factor (BDNF)
247340|NCT01045031|O1|Outcome|Marathon Athletes|Brain-derived Neurotrophic Factor (BDNF)
247341|NCT01045031|E2|Reported Event|Athletes|
247342|NCT01045031|E1|Reported Event|Controls|
247343|NCT01044862|B4|Baseline|Total|Total of all reporting groups
247344|NCT01044862|B3|Baseline|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247345|NCT01044862|B2|Baseline|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247346|NCT01044862|B1|Baseline|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247347|NCT01044862|P3|Participant Flow|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247348|NCT01044862|P2|Participant Flow|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247349|NCT01044862|P1|Participant Flow|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247350|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247351|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247409|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
247352|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247353|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247354|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247355|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247356|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247357|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247358|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247359|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247360|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247361|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247362|NCT01044862|E3|Reported Event|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
247363|NCT01044862|E2|Reported Event|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
247364|NCT01044862|E1|Reported Event|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
247365|NCT01044771|B1|Baseline|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
247366|NCT01044771|P1|Participant Flow|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day"
247367|NCT01044771|O1|Outcome|Viral Rebound|Every participant in the study switched to the investigational strategy
247368|NCT01044771|O1|Outcome|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients~change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID"
247369|NCT01044771|E1|Reported Event|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
247370|NCT01044732|B3|Baseline|Total|Total of all reporting groups
247371|NCT01044732|B2|Baseline|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247372|NCT01044732|B1|Baseline|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247373|NCT01044732|P2|Participant Flow|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247374|NCT01044732|P1|Participant Flow|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247375|NCT01044732|O2|Outcome|All TEC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)
247376|NCT01044732|O1|Outcome|All SC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)
247377|NCT01044732|O2|Outcome|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247378|NCT01044732|O1|Outcome|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247379|NCT01044732|E2|Reported Event|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247380|NCT01044732|E1|Reported Event|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
247381|NCT01044706|B3|Baseline|Total|Total of all reporting groups
247382|NCT01044706|B2|Baseline|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
247383|NCT01044706|B1|Baseline|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
247384|NCT01044706|P2|Participant Flow|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
247385|NCT01044706|P1|Participant Flow|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
247386|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
247387|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
247388|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
247389|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
247390|NCT01044706|E2|Reported Event|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
247391|NCT01044706|E1|Reported Event|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
247392|NCT01044693|B1|Baseline|All Study Participants|Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order
247393|NCT01044693|P16|Participant Flow|Placebo Then Nebivolol Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247394|NCT01044693|P15|Participant Flow|Nebivolol Then Placebo Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247395|NCT01044693|P14|Participant Flow|Nebivolol Then Sildenafil Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247396|NCT01044693|P13|Participant Flow|Sildenafil Then Metoprolol Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247397|NCT01044693|P12|Participant Flow|Sildenafil Then Nebivolol Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247398|NCT01044693|P11|Participant Flow|Metoprolol Then Sildenafil Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247399|NCT01044693|P10|Participant Flow|Metoprolol Then Nebivolol Then Placebo Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247400|NCT01044693|P9|Participant Flow|Nebivolol Then Metoprolol Then Sildenafil Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247401|NCT01044693|P8|Participant Flow|Metoprolol Then Placebo Then Nebivolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247402|NCT01044693|P7|Participant Flow|Sildenafil Then Nebivolol Then Placebo Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247403|NCT01044693|P6|Participant Flow|Metoprolol Then Sildenafil Then Placebo Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247404|NCT01044693|P5|Participant Flow|Nebivolol Then Placebo Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247405|NCT01044693|P4|Participant Flow|Placebo Then Sildenafil Then Metoprolol Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247406|NCT01044693|P3|Participant Flow|Placebo Then Sildenafil Then Nebivolol Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247407|NCT01044693|P2|Participant Flow|Placebo Then Nebivolol Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
247410|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
247411|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
247412|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
247413|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
247414|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
247415|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
247416|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
247417|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
247418|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
247419|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
247420|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
247421|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
247422|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
247423|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
247424|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
247425|NCT01044693|E4|Reported Event|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
247426|NCT01044693|E3|Reported Event|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
247427|NCT01044693|E2|Reported Event|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
247428|NCT01044693|E1|Reported Event|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
247429|NCT01044498|B3|Baseline|Total|Total of all reporting groups
247430|NCT01044498|B2|Baseline|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247431|NCT01044498|B1|Baseline|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247432|NCT01044498|P2|Participant Flow|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247433|NCT01044498|P1|Participant Flow|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247434|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247435|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247436|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247437|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247438|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247439|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247440|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247441|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247442|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247443|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247444|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247445|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247446|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247447|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247448|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247449|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247450|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247451|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247452|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247453|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247454|NCT01044498|E2|Reported Event|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
247455|NCT01044498|E1|Reported Event|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
247456|NCT01044459|B3|Baseline|Total|Total of all reporting groups
247457|NCT01044459|B2|Baseline|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247458|NCT01044459|B1|Baseline|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247459|NCT01044459|P2|Participant Flow|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247460|NCT01044459|P1|Participant Flow|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247461|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247462|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247463|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247464|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247465|NCT01044459|E2|Reported Event|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247466|NCT01044459|E1|Reported Event|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
247467|NCT01044303|B1|Baseline|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
247468|NCT01044303|P1|Participant Flow|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
247469|NCT01044303|O3|Outcome|Renal Function|Number of patients who had stable renal function throughout the study.
247470|NCT01044303|O2|Outcome|Rate of Rejection|Number of patients who had a rejection during the course of the study.
247471|NCT01044303|O1|Outcome|Rate of Infection|Number of patients who had an infection during the course of the study.
247472|NCT01044303|O1|Outcome|Mycophenolic Acid (MPA) Escalation|Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
247473|NCT01044303|E1|Reported Event|Adverse Events|Adverse events reported by participants during the course of the study.
247474|NCT01044290|B4|Baseline|Total|Total of all reporting groups
247475|NCT01044290|B3|Baseline|Arm 3 Treatment as Usual|"Subjects in the third group (Treatment as Usual) were exposed to no intervention or attention control during the intervention window."
247476|NCT01044290|B2|Baseline|Arm 2 Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
247477|NCT01044290|B1|Baseline|Arm 1 -Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
247478|NCT01044290|P3|Participant Flow|Arm 3 Treatment as Usual|"Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window."
247479|NCT01044290|P2|Participant Flow|Attention Control|"Subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
247480|NCT01044290|P1|Participant Flow|Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy."
247600|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
247481|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
247482|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received relaxation meditation as the attention control condition
247483|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
247484|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual.
247485|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control.
247486|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
247487|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants did not receive any intervention but rather care as usual.
247488|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition
247489|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
247490|NCT01044290|O3|Outcome|Arm 3 Usual Care|Participants did not receive any intervention but rather care as usual.
247491|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition.
247492|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
247493|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
247494|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control condition.
247495|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
247496|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual
247497|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control
247498|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
247499|NCT01044290|E3|Reported Event|Treatment as Usual|"Subjects in the third group (treatment as usual) will be exposed to no intervention or attention control during the intervention window."
247500|NCT01044290|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD."
247501|NCT01044290|E1|Reported Event|Outlook Intervention|"Subjects in the first group (Life Completion) will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
247502|NCT01044264|B4|Baseline|Total|Total of all reporting groups
247503|NCT01044264|B3|Baseline|Placebo|Placebo : Placebo
247504|NCT01044264|B2|Baseline|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247505|NCT01044264|B1|Baseline|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247506|NCT01044264|P3|Participant Flow|Placebo|Placebo : Placebo
247507|NCT01044264|P2|Participant Flow|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247508|NCT01044264|P1|Participant Flow|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247509|NCT01044264|O3|Outcome|Placebo|Placebo : Placebo
247510|NCT01044264|O2|Outcome|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247511|NCT01044264|O1|Outcome|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247512|NCT01044264|E3|Reported Event|Placebo|Placebo : Placebo
247513|NCT01044264|E2|Reported Event|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247514|NCT01044264|E1|Reported Event|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
247515|NCT01044212|B3|Baseline|Total|Total of all reporting groups
247516|NCT01044212|B2|Baseline|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247517|NCT01044212|B1|Baseline|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247518|NCT01044212|P2|Participant Flow|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247519|NCT01044212|P1|Participant Flow|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247520|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247521|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247522|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247523|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247524|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247525|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247526|NCT01044212|E2|Reported Event|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
247601|NCT01043874|E1|Reported Event|Nilotinib|Nilotinib 400 mg BID
247527|NCT01044212|E1|Reported Event|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
247528|NCT01044056|B4|Baseline|Total|Total of all reporting groups
247529|NCT01044056|B3|Baseline|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247530|NCT01044056|B2|Baseline|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247531|NCT01044056|B1|Baseline|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247532|NCT01044056|P3|Participant Flow|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247533|NCT01044056|P2|Participant Flow|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247534|NCT01044056|P1|Participant Flow|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247535|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247536|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247537|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247538|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247539|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247540|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247541|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247542|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247543|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247544|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
247545|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
247546|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
247547|NCT01044056|E3|Reported Event|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
247548|NCT01044056|E2|Reported Event|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day.
247549|NCT01044056|E1|Reported Event|Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days.
247550|NCT01044030|B3|Baseline|Total|Total of all reporting groups
247551|NCT01044030|B2|Baseline|Placebo|Placebo: 7.5 mL by mouth three times daily
247552|NCT01044030|B1|Baseline|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
247553|NCT01044030|P2|Participant Flow|Placebo|Placebo: 7.5 mL by mouth three times daily
247554|NCT01044030|P1|Participant Flow|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
247559|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
247560|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
247561|NCT01044030|E2|Reported Event|Placebo|Placebo: 7.5 mL by mouth three times daily
247562|NCT01044030|E1|Reported Event|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
247563|NCT01043939|B1|Baseline|Entire Study Population|Includes groups randomized to receive purple grape juice first and apple juice first
247564|NCT01043939|P2|Participant Flow|Arm 2 Apple Juice Then Purple Grape Juice|Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).
247565|NCT01043939|P1|Participant Flow|Arm 1 Purple Grape Juice Then Apple Juice|Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).
247566|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
247567|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
247568|NCT01043939|O2|Outcome|Arm 2 Apple Juice Then Purple Grape Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
247569|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
247570|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
247571|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
247572|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
247573|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
247574|NCT01043939|E2|Reported Event|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
247575|NCT01043939|E1|Reported Event|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
247576|NCT01043926|B3|Baseline|Total|Total of all reporting groups
247577|NCT01043926|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247578|NCT01043926|B1|Baseline|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247579|NCT01043926|P4|Participant Flow|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
247580|NCT01043926|P3|Participant Flow|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
247581|NCT01043926|P2|Participant Flow|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247582|NCT01043926|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247583|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247584|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247585|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247586|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247587|NCT01043926|O2|Outcome|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
247588|NCT01043926|O1|Outcome|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
247589|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247590|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247591|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247592|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247593|NCT01043926|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247594|NCT01043926|E1|Reported Event|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
247595|NCT01043874|B1|Baseline|Nilotinib|Nilotinib 400 mg BID
247596|NCT01043874|P1|Participant Flow|Nilotinib|Nilotinib 400 mg BID
247597|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
247598|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
247599|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
247603|NCT01043705|B3|Baseline|CIED Replacement With CRT and TYRX Vs. Case Match Arm|Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
247604|NCT01043705|B2|Baseline|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
247605|NCT01043705|B1|Baseline|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
247606|NCT01043705|P3|Participant Flow|CRT With no TYRX Retrospective Case Control|Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
247607|NCT01043705|P2|Participant Flow|CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants|Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
247608|NCT01043705|P1|Participant Flow|ICD With TYRX Implant|All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
247609|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
247610|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
247611|NCT01043705|O1|Outcome|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
247612|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
247613|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
247614|NCT01043705|O1|Outcome|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
247615|NCT01043705|E2|Reported Event|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
247616|NCT01043705|E1|Reported Event|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
247617|NCT01043653|B1|Baseline|Group 1|Individuals with serious mental illness treated in VA mental health outpatient programs
247618|NCT01043653|P1|Participant Flow|Group 1|Individuals with serious mental illness treated in mental health outpatient programs
247619|NCT01043653|O1|Outcome|Group 1|Individuals with serious mental illness treated in VA mental health outpatient programs
247620|NCT01043653|O1|Outcome|Group 1|Individuals with serious mental illness treated in VA mental health outpatient programs
247621|NCT01043653|E1|Reported Event|Group 1|Individuals with serious mental illness treated in mental health outpatient programs
247622|NCT01043523|B1|Baseline|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247623|NCT01043523|P1|Participant Flow|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247624|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247625|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247626|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247627|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247628|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247629|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
247630|NCT01043523|O1|Outcome|Precontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
247631|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247632|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247633|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
247634|NCT01043523|O1|Outcome|Precontrast|45 subjects had a change based on the Precontrast image read
247635|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247636|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247637|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247638|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247639|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247640|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247641|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247642|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247643|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247644|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247645|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
247646|NCT01043523|E1|Reported Event|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
247647|NCT01043432|B5|Baseline|Total|Total of all reporting groups
247648|NCT01043432|B4|Baseline|No TBI and no History of Suicidal Behavior Group 4|No TBI and no history of suicidal behavior
247649|NCT01043432|B3|Baseline|No TBI and a History of Suicidal Behavior Group 3|No TBI and a history of suicidal behavior
247650|NCT01043432|B2|Baseline|Moderate/Severe TBI and no History of Suicidal behaviorGroup 2|Moderate/Severe TBI and no history of suicidal behavior
247651|NCT01043432|B1|Baseline|Moderate/Severe TBI and History of Suicidal Behavior Group 1|Moderate/severe TBI and history of suicidal behavior
247652|NCT01043432|P4|Participant Flow|Group 4|No TBI and no history of suicidal behavior = 48
247653|NCT01043432|P3|Participant Flow|Group 3|No TBI and a history of suicidal behavior = 12
247654|NCT01043432|P2|Participant Flow|Group 2|Moderate/Severe TBI and no history of suicidal behavior = 51
247655|NCT01043432|P1|Participant Flow|Group 1|Moderate/severe TBI and history of suicidal behavior = 22
247656|NCT01043432|O4|Outcome|Group 4|No TBI and no history of suicidal behavior
247657|NCT01043432|O3|Outcome|Group 3|No TBI and a history of suicidal behavior
247658|NCT01043432|O2|Outcome|Group 2|Moderate/Severe TBI and no history of suicidal behavior
247659|NCT01043432|O1|Outcome|Group 1|Moderate/severe TBI and history of suicidal behavior
247660|NCT01043432|E1|Reported Event|All Groups|
247661|NCT01043393|B3|Baseline|Total|Total of all reporting groups
247662|NCT01043393|B2|Baseline|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247663|NCT01043393|B1|Baseline|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247664|NCT01043393|P2|Participant Flow|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247665|NCT01043393|P1|Participant Flow|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247666|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247709|NCT01043185|E1|Reported Event|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
247710|NCT01043146|B7|Baseline|Total|Total of all reporting groups
247711|NCT01043146|B6|Baseline|240 mg COR-1|single intravenous administration
247667|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247668|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247669|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247670|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247671|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247672|NCT01043393|E2|Reported Event|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247673|NCT01043393|E1|Reported Event|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
247674|NCT01043185|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 10 sequences of drug or placebo.
247675|NCT01043185|P10|Participant Flow|First Placebo, Then 120mg, Then 30mg, Then 240mg|Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
247676|NCT01043185|P9|Participant Flow|First 240mg, Then 30mg, Then 90mg, Then Placebo|Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
247677|NCT01043185|P8|Participant Flow|First 120mg, Then 30mg, Then 240mg, Then Placebo|Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
247678|NCT01043185|P7|Participant Flow|First 90mg, Then 120mg, Then Placebo, Then 240mg|Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
247679|NCT01043185|P6|Participant Flow|First Placebo, Then 240mg, Then 90mg, Then 30mg|Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
247680|NCT01043185|P5|Participant Flow|First 90mg, Then Placebo, Then 120mg, Then 240mg|Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
247681|NCT01043185|P4|Participant Flow|First Placebo, Then 30mg, Then 90mg, Then 120mg|Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
247682|NCT01043185|P3|Participant Flow|First 120mg, Then Placebo, Then 240mg, Then 90mg|Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
247683|NCT01043185|P2|Participant Flow|First 30mg, Then 90mg, Then Placebo, Then 120mg|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
247684|NCT01043185|P1|Participant Flow|First 30mg, Then 90mg, Then 120mg, Then Placebo|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
247685|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
247686|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
247687|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
247688|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
247689|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
247690|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
247691|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
247692|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
247693|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
247694|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
247695|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
247696|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
247697|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
247698|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
247699|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
247700|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
247701|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
247702|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
247703|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
247704|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
247705|NCT01043185|E5|Reported Event|Placebo|a morning and an evening dose of placebo
247706|NCT01043185|E4|Reported Event|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
247707|NCT01043185|E3|Reported Event|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
247708|NCT01043185|E2|Reported Event|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
247712|NCT01043146|B5|Baseline|160 mg COR-1|single intravenous administration
247713|NCT01043146|B4|Baseline|80 mg COR-1|single intravenous administration
247714|NCT01043146|B3|Baseline|40 mg COR-1|single intravenous administration
247715|NCT01043146|B2|Baseline|10 mg COR-1|single intravenous administration
247716|NCT01043146|B1|Baseline|Placebo|intravenous 0.9 % NaCl
247717|NCT01043146|P6|Participant Flow|240 mg COR-1|single intravenous administration
247718|NCT01043146|P5|Participant Flow|160 mg COR-1|single intravenous administration
247719|NCT01043146|P4|Participant Flow|80 mg COR-1|single intravenous administration
247720|NCT01043146|P3|Participant Flow|40 mg COR-1|single intravenous administration
247721|NCT01043146|P2|Participant Flow|10 mg COR-1|single intravenous administration
247722|NCT01043146|P1|Participant Flow|Placebo|intravenous 0.9 % NaCl
247723|NCT01043146|O6|Outcome|240 mg COR-1|single intravenous administration
247724|NCT01043146|O5|Outcome|160 mg COR-1|single intravenous administration
247725|NCT01043146|O4|Outcome|80 mg COR-1|single intravenous administration
247726|NCT01043146|O3|Outcome|40 mg COR-1|single intravenous administration
247727|NCT01043146|O2|Outcome|10 mg COR-1|single intravenous administration
247728|NCT01043146|O1|Outcome|Placebo|intravenous 0.9 % NaCl
247729|NCT01043146|E6|Reported Event|240 mg COR-1|single intravenous administration
247730|NCT01043146|E5|Reported Event|160 mg COR-1|single intravenous administration
247731|NCT01043146|E4|Reported Event|80 mg COR-1|single intravenous administration
247732|NCT01043146|E3|Reported Event|40 mg COR-1|single intravenous administration
247733|NCT01043146|E2|Reported Event|10 mg COR-1|single intravenous administration
247734|NCT01043146|E1|Reported Event|Placebo|intravenous 0.9 % NaCl
247735|NCT01043133|B3|Baseline|Total|Total of all reporting groups
247736|NCT01043133|B2|Baseline|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
247737|NCT01043133|B1|Baseline|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
247738|NCT01043133|P2|Participant Flow|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
247739|NCT01043133|P1|Participant Flow|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
247740|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
247741|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
247742|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
247743|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
247744|NCT01043133|E2|Reported Event|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
247745|NCT01043133|E1|Reported Event|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
247746|NCT01043094|B3|Baseline|Total|Total of all reporting groups
247747|NCT01043094|B2|Baseline|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
247748|NCT01043094|B1|Baseline|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
247749|NCT01043094|P2|Participant Flow|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
247750|NCT01043094|P1|Participant Flow|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
247751|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
247752|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
247753|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
247754|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
247755|NCT01043094|E2|Reported Event|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
247756|NCT01043094|E1|Reported Event|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
247757|NCT01042977|B3|Baseline|Total|Total of all reporting groups
247758|NCT01042977|B2|Baseline|Placebo|Placebo plus usual care
247759|NCT01042977|B1|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247760|NCT01042977|P2|Participant Flow|Placebo|Placebo plus usual care
247761|NCT01042977|P1|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247762|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247763|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247765|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247766|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247767|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247768|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247769|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247770|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247771|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247772|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247773|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247774|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
247775|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247776|NCT01042977|E2|Reported Event|Placebo|Placebo plus usual care
247777|NCT01042977|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus usual care
247778|NCT01042938|B3|Baseline|Total|Total of all reporting groups
247779|NCT01042938|B2|Baseline|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247780|NCT01042938|B1|Baseline|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247781|NCT01042938|P2|Participant Flow|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247782|NCT01042938|P1|Participant Flow|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247783|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247784|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247785|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247786|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247787|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247788|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247789|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
247790|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
247791|NCT01042938|E2|Reported Event|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247792|NCT01042938|E1|Reported Event|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
247793|NCT01042678|B4|Baseline|Total|Total of all reporting groups
247794|NCT01042678|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247795|NCT01042678|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247796|NCT01042678|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247797|NCT01042678|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
247798|NCT01042678|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
247799|NCT01042678|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
247800|NCT01042678|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247801|NCT01042678|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247802|NCT01042678|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247803|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247804|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247805|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247806|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247807|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247808|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247809|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247810|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247811|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247812|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247813|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247814|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247815|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247816|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247817|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247818|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247819|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247820|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247821|NCT01042678|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
247822|NCT01042678|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
247823|NCT01042678|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
247824|NCT01042613|B3|Baseline|Total|Total of all reporting groups
247825|NCT01042613|B2|Baseline|Standard|(standard technique of insertion of the intravenous cannula)
247826|NCT01042613|B1|Baseline|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247827|NCT01042613|P2|Participant Flow|Standard|(standard technique of insertion of the intravenous cannula)
247828|NCT01042613|P1|Participant Flow|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247829|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
247830|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247831|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
247832|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247833|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
247834|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247835|NCT01042613|E2|Reported Event|Standard|(standard technique of insertion of the intravenous cannula)
247836|NCT01042613|E1|Reported Event|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
247837|NCT01042600|B3|Baseline|Total|Total of all reporting groups
247838|NCT01042600|B2|Baseline|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
247839|NCT01042600|B1|Baseline|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
247840|NCT01042600|P2|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
247841|NCT01042600|P1|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
247842|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
247843|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
247844|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
247845|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
247846|NCT01042600|E2|Reported Event|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
247847|NCT01042600|E1|Reported Event|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
247848|NCT01042535|B1|Baseline|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247849|NCT01042535|P1|Participant Flow|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247850|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
248067|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
247851|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247852|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247853|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247854|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247855|NCT01042535|E1|Reported Event|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
247856|NCT01042509|B1|Baseline|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
247857|NCT01042509|P1|Participant Flow|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
247858|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
247859|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
247860|NCT01042509|E1|Reported Event|Treatment Group|This study had only one arm
247861|NCT01042496|B3|Baseline|Total|Total of all reporting groups
247862|NCT01042496|B2|Baseline|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247863|NCT01042496|B1|Baseline|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247864|NCT01042496|P2|Participant Flow|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247865|NCT01042496|P1|Participant Flow|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247866|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
247867|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247868|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
247946|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
248174|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
247869|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247870|NCT01042496|O4|Outcome|Bipolar Lamotrigine Group as Whole|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
247871|NCT01042496|O3|Outcome|Bipolar Lamotrigine Non-Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~Non-responders were those bipolar participants who did not achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12)."
247872|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247873|NCT01042496|O1|Outcome|Bipolar Lamotrigine Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247874|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247875|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247876|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247877|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247878|NCT01042496|E2|Reported Event|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247879|NCT01042496|E1|Reported Event|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
247880|NCT01042392|B3|Baseline|Total|Total of all reporting groups
247881|NCT01042392|B2|Baseline|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247882|NCT01042392|B1|Baseline|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247883|NCT01042392|P4|Participant Flow|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247912|NCT01042288|P1|Participant Flow|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247884|NCT01042392|P3|Participant Flow|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247885|NCT01042392|P2|Participant Flow|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247886|NCT01042392|P1|Participant Flow|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247887|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247888|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247889|NCT01042392|O4|Outcome|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247890|NCT01042392|O3|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247891|NCT01042392|O2|Outcome|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247892|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247893|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247894|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247895|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247896|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247897|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247913|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
248003|NCT01042093|E2|Reported Event|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
247898|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247899|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247900|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247901|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247902|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247903|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247904|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247905|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247906|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247907|NCT01042392|E4|Reported Event|Placebo to Aliskiren (Period III)|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247908|NCT01042392|E3|Reported Event|Aliskiren (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247909|NCT01042392|E2|Reported Event|Placebo to Ramipril (Period III)|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
247910|NCT01042392|E1|Reported Event|Ramipril (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
247911|NCT01042288|B1|Baseline|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247945|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
248065|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
247914|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247915|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247916|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247917|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247918|NCT01042288|E1|Reported Event|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
247919|NCT01042236|B1|Baseline|Entire Study Population|Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
247920|NCT01042236|P6|Participant Flow|Sequence CBA|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
247921|NCT01042236|P5|Participant Flow|Sequence BAC|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
247922|NCT01042236|P4|Participant Flow|Sequence ACB|Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
247923|NCT01042236|P3|Participant Flow|Sequence CAB|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
247924|NCT01042236|P2|Participant Flow|Sequence BCA|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
247925|NCT01042236|P1|Participant Flow|Sequence ABC|Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
247926|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247927|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247928|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247929|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247930|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247931|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247932|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247933|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247934|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247935|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247936|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247937|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247938|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247939|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247940|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247941|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247942|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247943|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247944|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
248175|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
247947|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247948|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247949|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247950|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247951|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247952|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247953|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247954|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247955|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247956|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247957|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247958|NCT01042236|E3|Reported Event|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
247959|NCT01042236|E2|Reported Event|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247960|NCT01042236|E1|Reported Event|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
247961|NCT01042145|B3|Baseline|Total|Total of all reporting groups
247962|NCT01042145|B2|Baseline|Dexamethasone|
247963|NCT01042145|B1|Baseline|Prednisone|
247964|NCT01042145|P2|Participant Flow|Dexamethasone|
247965|NCT01042145|P1|Participant Flow|Prednisone|
247966|NCT01042145|O2|Outcome|Dexamethasone|
247967|NCT01042145|O1|Outcome|Prednisone|
247968|NCT01042145|O2|Outcome|Dexamethasone|
247969|NCT01042145|O1|Outcome|Prednisone|
247970|NCT01042145|O2|Outcome|Dexamethasone|
247971|NCT01042145|O1|Outcome|Prednisone|
247972|NCT01042145|O2|Outcome|Dexamethasone|
247973|NCT01042145|O1|Outcome|Prednisone|
247974|NCT01042145|O2|Outcome|Dexamethasone|
247975|NCT01042145|O1|Outcome|Prednisone|
247976|NCT01042145|O2|Outcome|Dexamethasone|
247977|NCT01042145|O1|Outcome|Prednisone|
247978|NCT01042145|E2|Reported Event|Dexamethasone|
247979|NCT01042145|E1|Reported Event|Prednisone|
247980|NCT01042093|B5|Baseline|Total|Total of all reporting groups
247981|NCT01042093|B4|Baseline|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
247982|NCT01042093|B3|Baseline|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247983|NCT01042093|B2|Baseline|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
247984|NCT01042093|B1|Baseline|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247985|NCT01042093|P4|Participant Flow|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
247986|NCT01042093|P3|Participant Flow|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247987|NCT01042093|P2|Participant Flow|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
247988|NCT01042093|P1|Participant Flow|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247989|NCT01042093|O4|Outcome|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
247990|NCT01042093|O3|Outcome|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247991|NCT01042093|O2|Outcome|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
247992|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247993|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
247994|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247995|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
247996|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247997|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
247998|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
247999|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
248000|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
248001|NCT01042093|E4|Reported Event|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
248002|NCT01042093|E3|Reported Event|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
254476|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
248004|NCT01042093|E1|Reported Event|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
248005|NCT01041976|B3|Baseline|Total|Total of all reporting groups
248006|NCT01041976|B2|Baseline|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
248007|NCT01041976|B1|Baseline|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
248008|NCT01041976|P2|Participant Flow|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
248009|NCT01041976|P1|Participant Flow|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
248010|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
248011|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
248012|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
248013|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
248014|NCT01041976|E2|Reported Event|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
248015|NCT01041976|E1|Reported Event|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
248016|NCT01041859|B3|Baseline|Total|Total of all reporting groups
248017|NCT01041859|B2|Baseline|DB Placebo|Double-Blind Placebo Control Group
248018|NCT01041859|B1|Baseline|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248019|NCT01041859|P3|Participant Flow|DB Placebo|Double-Blind Placebo Control Group
248020|NCT01041859|P2|Participant Flow|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248021|NCT01041859|P1|Participant Flow|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
248022|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
248023|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248024|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
248025|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248026|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
248027|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248028|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
248029|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248030|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
248031|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248032|NCT01041859|E3|Reported Event|DB Placebo|Double-Blind Placebo Control Group
248033|NCT01041859|E2|Reported Event|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
248034|NCT01041859|E1|Reported Event|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
248066|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248035|NCT01041638|B1|Baseline|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
248036|NCT01041638|P1|Participant Flow|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
248037|NCT01041638|O1|Outcome|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
248038|NCT01041638|E1|Reported Event|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
248039|NCT01041573|B5|Baseline|Total|Total of all reporting groups
248040|NCT01041573|B4|Baseline|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
248041|NCT01041573|B3|Baseline|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
248042|NCT01041573|B2|Baseline|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
248043|NCT01041573|B1|Baseline|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
248044|NCT01041573|P4|Participant Flow|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
248045|NCT01041573|P3|Participant Flow|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
248046|NCT01041573|P2|Participant Flow|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
248047|NCT01041573|P1|Participant Flow|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
248048|NCT01041573|O4|Outcome|Prevnar|"Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).~Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
248049|NCT01041573|O3|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7
248050|NCT01041573|O2|Outcome|IC51, Subjects Aged >= 2 Months to <1 Year|Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
248051|NCT01041573|O1|Outcome|IC51, Subjects Aged >= 1 Year|IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
248052|NCT01041573|E4|Reported Event|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
248053|NCT01041573|E3|Reported Event|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
248054|NCT01041573|E2|Reported Event|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
248055|NCT01041573|E1|Reported Event|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
248056|NCT01041417|B3|Baseline|Total|Total of all reporting groups
248057|NCT01041417|B2|Baseline|Placebo|Saline injection - three times for four weeks
248058|NCT01041417|B1|Baseline|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248059|NCT01041417|P2|Participant Flow|Placebo|Saline injection - three times for four weeks
248060|NCT01041417|P1|Participant Flow|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248061|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248062|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248063|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248064|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248068|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248069|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248070|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248071|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248072|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248073|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
248074|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
248075|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
248076|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
248077|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
248078|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
248079|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
248080|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
248081|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248082|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248083|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
248084|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
248085|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248086|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248087|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248088|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248089|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248090|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248091|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
248092|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
248093|NCT01041417|E2|Reported Event|Placebo|Saline injection - Monday, Wednesday and Friday for 4 weeks.
248094|NCT01041417|E1|Reported Event|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.~500 microgram dose of GM-CSF"
248095|NCT01041404|B3|Baseline|Total|Total of all reporting groups
248096|NCT01041404|B2|Baseline|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248097|NCT01041404|B1|Baseline|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248098|NCT01041404|P2|Participant Flow|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248099|NCT01041404|P1|Participant Flow|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
248100|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248176|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248177|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248178|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248101|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248102|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248103|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248104|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248105|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248106|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248107|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248108|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248109|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248110|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248111|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248112|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248113|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248179|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248180|NCT01040871|E2|Reported Event|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248114|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248115|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248116|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248117|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248118|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248119|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248120|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248121|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248122|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248123|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248124|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248125|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248126|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248127|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248128|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248129|NCT01041404|O2|Outcome|Trastuzumab, Fluoropyrimidine, Cisplatin|Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
248130|NCT01041404|O1|Outcome|Fluoropyrimidine, Cisplatin|Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
248131|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248132|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248133|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248134|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248135|NCT01041404|E2|Reported Event|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
248136|NCT01041404|E1|Reported Event|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
248137|NCT01041287|B3|Baseline|Total|Total of all reporting groups
248138|NCT01041287|B2|Baseline|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for 3 months. They crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248139|NCT01041287|B1|Baseline|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for 3 months. They crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248140|NCT01041287|P2|Participant Flow|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248141|NCT01041287|P1|Participant Flow|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248142|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248143|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248144|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248145|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248146|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248147|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248148|NCT01041287|E2|Reported Event|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248149|NCT01041287|E1|Reported Event|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
248150|NCT01041209|B3|Baseline|Total|Total of all reporting groups
248151|NCT01041209|B2|Baseline|Guideline|Enforced guidelines
248152|NCT01041209|B1|Baseline|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
248153|NCT01041209|P2|Participant Flow|Guideline|Use of antibiotics according to local enforced guidelines
248154|NCT01041209|P1|Participant Flow|Bacterial Pneumonia Score (BPS)|Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points)
248155|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital)guidelines.
248156|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
248157|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital) guidelines
248158|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
248159|NCT01041209|E2|Reported Event|Guideline|Enforced guidelines
248160|NCT01041209|E1|Reported Event|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
248161|NCT01040871|B3|Baseline|Total|Total of all reporting groups
248162|NCT01040871|B2|Baseline|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248163|NCT01040871|B1|Baseline|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248164|NCT01040871|P2|Participant Flow|R-CHOP|R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
248165|NCT01040871|P1|Participant Flow|VR-CAP|VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
248166|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248167|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248168|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248169|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248170|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248171|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248172|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
248173|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248181|NCT01040871|E1|Reported Event|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
248182|NCT01040858|B3|Baseline|Total|Total of all reporting groups
248183|NCT01040858|B2|Baseline|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248184|NCT01040858|B1|Baseline|Cognitive Strategies Group|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248185|NCT01040858|P2|Participant Flow|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248186|NCT01040858|P1|Participant Flow|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248187|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248188|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248189|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248190|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248191|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248192|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248193|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248194|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248195|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248196|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248197|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248198|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248199|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248200|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248201|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248202|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248203|NCT01040858|O2|Outcome|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248204|NCT01040858|O1|Outcome|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248205|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248206|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248207|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248208|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248209|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248210|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248211|NCT01040858|E2|Reported Event|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
248212|NCT01040858|E1|Reported Event|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
248213|NCT01040845|B3|Baseline|Total|Total of all reporting groups
248214|NCT01040845|B2|Baseline|Oral Contraceptive With Colchicine Then Placebo|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
248215|NCT01040845|B1|Baseline|Oral Contraceptive With Placebo Then Colchicine|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
248216|NCT01040845|P2|Participant Flow|Oral Contraceptive With Colchicine Then Placebo|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
248217|NCT01040845|P1|Participant Flow|Oral Contraceptive With Placebo Then Colchicine|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
248218|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248219|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248220|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248221|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248267|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248268|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248269|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248270|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248222|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248223|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248224|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248225|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248226|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248227|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248228|NCT01040845|E1|Reported Event|Oral Contraceptive With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
248229|NCT01040832|B3|Baseline|Total|Total of all reporting groups
248230|NCT01040832|B2|Baseline|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248231|NCT01040832|B1|Baseline|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248232|NCT01040832|P2|Participant Flow|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248233|NCT01040832|P1|Participant Flow|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248234|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248271|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248272|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248273|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248235|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248236|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248237|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248238|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248239|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248240|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248241|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248242|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248243|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248244|NCT01040832|E2|Reported Event|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248245|NCT01040832|E1|Reported Event|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
248246|NCT01040819|B3|Baseline|Total|Total of all reporting groups
248247|NCT01040819|B2|Baseline|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
248274|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248275|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248276|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248277|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248278|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248279|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248280|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248281|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248248|NCT01040819|B1|Baseline|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
248249|NCT01040819|P2|Participant Flow|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
248250|NCT01040819|P1|Participant Flow|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
248251|NCT01040819|O2|Outcome|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
248252|NCT01040819|O1|Outcome|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
248253|NCT01040819|E2|Reported Event|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
248254|NCT01040819|E1|Reported Event|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
248255|NCT01040793|B1|Baseline|Overall Study|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
248256|NCT01040793|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
248257|NCT01040793|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248258|NCT01040793|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
248259|NCT01040793|P3|Participant Flow|Olo 5mcg/ Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248260|NCT01040793|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248261|NCT01040793|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248262|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248263|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248264|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248265|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248266|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248282|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248283|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248284|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248285|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248286|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248287|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248288|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248289|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248290|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248291|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248292|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248293|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248294|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248295|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248296|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248297|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248298|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248299|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248300|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248301|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248302|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248303|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248304|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248305|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248306|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248307|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248308|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248309|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248310|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248311|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248312|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248313|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248314|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248315|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248316|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248317|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248318|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248319|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248320|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248321|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248322|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248323|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248324|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248325|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248326|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248327|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248328|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248329|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248330|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248331|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248332|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248333|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248334|NCT01040793|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248335|NCT01040793|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248336|NCT01040793|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248337|NCT01040780|B3|Baseline|Total|Total of all reporting groups
248338|NCT01040780|B2|Baseline|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248339|NCT01040780|B1|Baseline|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248340|NCT01040780|P2|Participant Flow|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248341|NCT01040780|P1|Participant Flow|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248342|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248343|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248344|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248345|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248346|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248347|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248349|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
248350|NCT01040780|O2|Outcome|Gefitinib|250 mg every 24 hours by mouth
248351|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
248352|NCT01040780|E2|Reported Event|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
248353|NCT01040780|E1|Reported Event|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
248354|NCT01040728|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 122 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
248355|NCT01040728|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|"Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
248356|NCT01040728|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|"Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
248357|NCT01040728|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|"Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
248358|NCT01040728|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|"Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
248359|NCT01040728|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248360|NCT01040728|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248361|NCT01040728|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248362|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248363|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248364|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248365|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248366|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248367|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248368|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248369|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248370|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248371|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248372|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248373|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248374|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248375|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248376|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248377|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248378|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248379|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248380|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248381|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248382|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248383|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248384|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248385|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248386|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248387|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248388|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248389|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248390|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248391|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248392|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248393|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248394|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248395|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248396|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248397|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248398|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248399|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248400|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248401|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248402|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248403|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248404|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248405|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248406|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248407|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248408|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
248409|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248410|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248411|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248412|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248413|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248414|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248415|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248416|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248417|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248418|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248419|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248420|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248421|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248422|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
248423|NCT01040728|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248424|NCT01040728|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248425|NCT01040728|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248426|NCT01040728|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
248427|NCT01040689|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
248428|NCT01040689|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
248429|NCT01040689|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
248430|NCT01040689|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
248431|NCT01040689|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
248432|NCT01040689|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248433|NCT01040689|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248434|NCT01040689|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248435|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248436|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248437|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248438|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248439|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248440|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248441|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248442|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248443|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248444|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248445|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248446|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248447|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248448|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248449|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248450|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248451|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248452|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248453|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248454|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248455|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248456|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248457|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248458|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248459|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248460|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248461|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248462|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248463|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248464|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248465|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248466|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248467|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248468|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248469|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248470|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248471|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248472|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248473|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248474|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248475|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248476|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248477|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248478|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248479|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248480|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248481|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
248482|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248483|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248484|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248485|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248486|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248487|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248488|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
248489|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248490|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248491|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248492|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248493|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248494|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248495|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248496|NCT01040689|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
248497|NCT01040689|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248498|NCT01040689|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248499|NCT01040689|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
248500|NCT01040624|B3|Baseline|Total|Total of all reporting groups
248501|NCT01040624|B2|Baseline|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248502|NCT01040624|B1|Baseline|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248503|NCT01040624|P2|Participant Flow|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248504|NCT01040624|P1|Participant Flow|HR-A|"< 15% risk of + lymph nodes (LN)~< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months."
248505|NCT01040624|O2|Outcome|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248506|NCT01040624|O1|Outcome|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248507|NCT01040624|E2|Reported Event|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248508|NCT01040624|E1|Reported Event|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
248509|NCT01039519|B1|Baseline|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248510|NCT01039519|P1|Participant Flow|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248511|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248512|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248513|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248514|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248515|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248516|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248517|NCT01039519|E1|Reported Event|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
248518|NCT01040403|B1|Baseline|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
248519|NCT01040403|P1|Participant Flow|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
248520|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248521|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248522|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248781|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248523|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248524|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248525|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248526|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248527|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248528|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248529|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248530|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248531|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248532|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248533|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248534|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248535|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248536|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248537|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248538|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248539|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248540|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248541|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248542|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248543|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248544|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248545|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248546|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248547|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248548|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248549|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248550|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248551|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248552|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248553|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248554|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248555|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248556|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248557|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248558|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248559|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248560|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248561|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248562|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248563|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248564|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248565|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248566|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248567|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248568|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248569|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248570|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248571|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248572|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248573|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248574|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248575|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248576|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248577|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248578|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248579|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248580|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248581|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248582|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248583|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248584|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248585|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248586|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248587|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248588|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248589|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248590|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248591|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248592|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248593|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248594|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248595|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248596|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248597|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248598|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248599|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248600|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248601|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248602|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248603|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248604|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248605|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248606|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248607|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248608|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248609|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248610|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248611|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248612|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248613|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248614|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248615|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248616|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248617|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248618|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248619|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248620|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248621|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248622|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248623|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248624|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248625|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248626|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248627|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248628|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248629|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248630|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248631|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248632|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248633|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248634|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248635|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248636|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248637|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248638|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248639|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248640|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248641|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248642|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248643|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248644|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248645|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248646|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248647|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248648|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248649|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248650|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248651|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248652|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248653|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248654|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248655|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248656|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248657|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248658|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248659|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248660|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248661|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248662|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248663|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248664|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248665|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248666|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248667|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248668|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248669|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248670|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248671|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248672|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248673|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248674|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248675|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248676|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248677|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248678|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248679|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248680|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248681|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248682|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248683|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248684|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248685|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248686|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248687|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248688|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248689|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
248690|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248691|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248692|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248693|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248694|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248695|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248696|NCT01040403|E8|Reported Event|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248697|NCT01040403|E7|Reported Event|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248698|NCT01040403|E6|Reported Event|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248699|NCT01040403|E5|Reported Event|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248700|NCT01040403|E4|Reported Event|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248701|NCT01040403|E3|Reported Event|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248702|NCT01040403|E2|Reported Event|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
248703|NCT01040403|E1|Reported Event|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
248704|NCT01040351|B3|Baseline|Total|Total of all reporting groups
248705|NCT01040351|B2|Baseline|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
248706|NCT01040351|B1|Baseline|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
248707|NCT01040351|P2|Participant Flow|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
248708|NCT01040351|P1|Participant Flow|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
248709|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
248710|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
248711|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
248712|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
248713|NCT01040351|E2|Reported Event|2. no Aspiration|IVF-ET without any prior intervention
248714|NCT01040351|E1|Reported Event|1: Hydrosalpinx Needle Aspiration|Aspiration of hydrosalpingeal fluid prior to IVF-ET
248715|NCT01040260|B3|Baseline|Total|Total of all reporting groups
248716|NCT01040260|B2|Baseline|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
248717|NCT01040260|B1|Baseline|Contingency Management|Use of tangible rewards for verified abstinence
248718|NCT01040260|P2|Participant Flow|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
248719|NCT01040260|P1|Participant Flow|Contingency Management|Use of tangible rewards for verified abstinence
248720|NCT01040260|O2|Outcome|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
248721|NCT01040260|O1|Outcome|Contingency Management|Use of tangible rewards for verified abstinence
248722|NCT01040260|E2|Reported Event|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
248723|NCT01040260|E1|Reported Event|Contingency Management|Use of tangible rewards for verified abstinence
248724|NCT01040208|B4|Baseline|Total|Total of all reporting groups
248725|NCT01040208|B3|Baseline|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
248726|NCT01040208|B2|Baseline|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
248727|NCT01040208|B1|Baseline|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
248728|NCT01040208|P3|Participant Flow|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
248729|NCT01040208|P2|Participant Flow|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
248730|NCT01040208|P1|Participant Flow|Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
248731|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
248732|NCT01040208|O2|Outcome|Flibanserin 100mg Qhs|
248733|NCT01040208|O1|Outcome|Flibanserin 50mg to 100mg Qhs|Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
248734|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
248735|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|
248736|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|
248737|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
248738|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
248739|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
248740|NCT01040208|E3|Reported Event|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
248741|NCT01040208|E2|Reported Event|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
248742|NCT01040208|E1|Reported Event|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
248743|NCT01040169|B3|Baseline|Total|Total of all reporting groups
248744|NCT01040169|B2|Baseline|ProClude Prophylaxis Paste|
248745|NCT01040169|B1|Baseline|Nupro C Prophylaxis Paste|
248746|NCT01040169|P2|Participant Flow|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
248747|NCT01040169|P1|Participant Flow|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
248748|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
248749|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
248750|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
248751|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
248752|NCT01040169|E2|Reported Event|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
248753|NCT01040169|E1|Reported Event|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
248754|NCT01040130|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
248755|NCT01040130|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
248756|NCT01040130|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248757|NCT01040130|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
248758|NCT01040130|P3|Participant Flow|Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248759|NCT01040130|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248760|NCT01040130|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
248761|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248762|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248763|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248764|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248765|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248766|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248767|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248768|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248769|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248770|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248771|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248772|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248773|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248774|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248775|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248776|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248777|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248778|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248779|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248780|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248782|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248783|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248784|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248785|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248786|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248787|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248788|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248789|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248790|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248791|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248792|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248793|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248794|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248795|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248796|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248797|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248798|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248799|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248800|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248801|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248802|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248803|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248804|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248805|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248806|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248807|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248808|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248809|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248810|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248811|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248812|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248813|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248814|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248815|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248816|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248817|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248818|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248819|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248820|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248821|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248822|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248823|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248824|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248825|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248826|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248827|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248828|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248829|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248830|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
248831|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
248832|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248833|NCT01040130|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
248834|NCT01040130|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
248835|NCT01040130|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
248836|NCT01040052|B1|Baseline|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
248837|NCT01040052|P1|Participant Flow|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
248838|NCT01040052|O1|Outcome|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
248839|NCT01040052|E1|Reported Event|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
248840|NCT01039675|B3|Baseline|Total|Total of all reporting groups
248841|NCT01039675|B2|Baseline|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
248842|NCT01039675|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
248843|NCT01039675|P2|Participant Flow|UMEC/VI 500/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 500/25 micrograms (µg) QD via a DPI in the morning for 4 weeks.
248844|NCT01039675|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 4 weeks.
248845|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
248846|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
248847|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
248848|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
248849|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
248850|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
248851|NCT01039675|E2|Reported Event|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
248852|NCT01039675|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
248853|NCT01039584|B4|Baseline|Total|Total of all reporting groups
248854|NCT01039584|B3|Baseline|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248855|NCT01039584|B2|Baseline|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248856|NCT01039584|B1|Baseline|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248857|NCT01039584|P3|Participant Flow|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248858|NCT01039584|P2|Participant Flow|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248859|NCT01039584|P1|Participant Flow|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248860|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248861|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248862|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248863|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248864|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248865|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248866|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248867|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248868|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248869|NCT01039584|E3|Reported Event|Placebo|"vehicle of the test product~Placebo : vaginal cream"
248870|NCT01039584|E2|Reported Event|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
248871|NCT01039584|E1|Reported Event|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
248872|NCT01039428|B3|Baseline|Total|Total of all reporting groups
248873|NCT01039428|B2|Baseline|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248874|NCT01039428|B1|Baseline|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248875|NCT01039428|P2|Participant Flow|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248876|NCT01039428|P1|Participant Flow|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248877|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248878|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248879|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248880|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248881|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248882|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248883|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248884|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248885|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248886|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248887|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248888|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248889|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248890|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248891|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248892|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248893|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
248894|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
249305|NCT01037244|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
248895|NCT01039428|E2|Reported Event|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248896|NCT01039428|E1|Reported Event|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
248897|NCT01039376|B3|Baseline|Total|Total of all reporting groups
248898|NCT01039376|B2|Baseline|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248899|NCT01039376|B1|Baseline|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248900|NCT01039376|P2|Participant Flow|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248901|NCT01039376|P1|Participant Flow|Ofatumumab|Participants with relapsed chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248902|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248903|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248904|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248905|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248906|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248907|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248908|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248909|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248910|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248911|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248912|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248913|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248914|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248915|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248916|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248917|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248918|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248919|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248920|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248921|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248922|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248923|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248924|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248925|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248926|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248927|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248928|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248929|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248930|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248931|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248932|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248933|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248934|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248935|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248936|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248937|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248938|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248939|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248940|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248941|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248942|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248943|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248944|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248945|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248946|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248947|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248948|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248949|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248950|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248951|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248952|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248953|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248954|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248955|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248956|NCT01039376|E2|Reported Event|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
248957|NCT01039376|E1|Reported Event|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
248958|NCT01038921|B3|Baseline|Total|Total of all reporting groups
248959|NCT01038921|B2|Baseline|Placebo First|Cross-over design with subjects receiving Placebo First
248960|NCT01038921|B1|Baseline|Melatonin First|Cross-over design with subjects receiving Melatonin First
248961|NCT01038921|P2|Participant Flow|Placebo|Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
248962|NCT01038921|P1|Participant Flow|Melatonin|Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second
248963|NCT01038921|O2|Outcome|Placebo|Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
248964|NCT01038921|O1|Outcome|Melatonin|Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks
248965|NCT01038921|E2|Reported Event|Placebo First|Cross-over design for subjects randomized to Placebo First, Melatonin Second
248966|NCT01038921|E1|Reported Event|Melatonin First|Cross-over design for subjects randomized to Melatonin First, Placebo Second
248967|NCT01038869|B1|Baseline|Finacea|Open label pilot study
248968|NCT01038869|P1|Participant Flow|Finacea|Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
248969|NCT01038869|O1|Outcome|Azelaic Acid 15%|tolerability assessments
248970|NCT01038869|O1|Outcome|Azelaic Acid 15%|lesion counts
248971|NCT01038869|O1|Outcome|Azelaic Acid 15%|
248972|NCT01038869|O1|Outcome|Azelaic Acis 15% Open Label|Assessments of PIH IGA
248973|NCT01038869|O1|Outcome|Azelaic Acid 15% Open Label|Assessments of IGA
248974|NCT01038869|E1|Reported Event|Finacea|Open label pilot study
248975|NCT01038752|B3|Baseline|Total|Total of all reporting groups
248976|NCT01038752|B2|Baseline|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248977|NCT01038752|B1|Baseline|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248978|NCT01038752|P2|Participant Flow|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo, Docetaxel, Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248979|NCT01038752|P1|Participant Flow|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin, Docetaxel, Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248980|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248981|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248982|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248983|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248984|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248985|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248986|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248987|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248988|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248989|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248990|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
249039|NCT01038635|P3|Participant Flow|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
249040|NCT01038635|P2|Participant Flow|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
248991|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248992|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248993|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248994|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248995|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248996|NCT01038752|E2|Reported Event|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248997|NCT01038752|E1|Reported Event|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
248998|NCT01038713|B4|Baseline|Total|Total of all reporting groups
248999|NCT01038713|B3|Baseline|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249000|NCT01038713|B2|Baseline|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249001|NCT01038713|B1|Baseline|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249002|NCT01038713|P3|Participant Flow|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249003|NCT01038713|P2|Participant Flow|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249004|NCT01038713|P1|Participant Flow|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249005|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249006|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249007|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249008|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249009|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249151|NCT01038323|P2|Participant Flow|Milnacipran|drug monotherapy
249152|NCT01038323|P1|Participant Flow|Combination|milnacipran and CBT
249010|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249011|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249012|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249013|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249014|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249015|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249016|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249017|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249018|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249019|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249020|NCT01038713|E3|Reported Event|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249021|NCT01038713|E2|Reported Event|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249022|NCT01038713|E1|Reported Event|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
249023|NCT01038635|B10|Baseline|Total|Total of all reporting groups
249024|NCT01038635|B9|Baseline|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
249025|NCT01038635|B8|Baseline|Phase II: 5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
249026|NCT01038635|B7|Baseline|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
249027|NCT01038635|B6|Baseline|5-AZA + LEN 75 mg 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
249028|NCT01038635|B5|Baseline|5-AZA + 50 LEN|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
249029|NCT01038635|B4|Baseline|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
249030|NCT01038635|B3|Baseline|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
249031|NCT01038635|B2|Baseline|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
249032|NCT01038635|B1|Baseline|5-AZA + LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
249033|NCT01038635|P9|Participant Flow|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
249034|NCT01038635|P8|Participant Flow|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
249035|NCT01038635|P7|Participant Flow|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
249036|NCT01038635|P6|Participant Flow|5-AZA + LEN 75 mg for 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
249037|NCT01038635|P5|Participant Flow|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
249038|NCT01038635|P4|Participant Flow|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
249257|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249041|NCT01038635|P1|Participant Flow|5-AZA + LEN 10 mg|Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
249042|NCT01038635|O1|Outcome|Overall Study: 5-AZA + LEN MTD|Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
249043|NCT01038635|O2|Outcome|Phase II: 5-AZA + LEN|All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
249044|NCT01038635|O1|Outcome|Phase I: 5-AZA + LEN MTD|5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
249045|NCT01038635|O7|Outcome|5-AZA + 10 Days LEN 75 mg 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
249046|NCT01038635|O6|Outcome|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
249047|NCT01038635|O5|Outcome|5-AZA + 5 Days LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
249048|NCT01038635|O4|Outcome|5-AZA + 5 Days LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
249049|NCT01038635|O3|Outcome|5-AZA + 5 Days LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
249050|NCT01038635|O2|Outcome|5-AZA + 5 Days LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
249051|NCT01038635|O1|Outcome|5-AZA + 5 Days LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
249052|NCT01038635|E9|Reported Event|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
249053|NCT01038635|E8|Reported Event|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
249054|NCT01038635|E7|Reported Event|5-AZA + 10 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
249055|NCT01038635|E6|Reported Event|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
249056|NCT01038635|E5|Reported Event|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
249057|NCT01038635|E4|Reported Event|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
249058|NCT01038635|E3|Reported Event|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
249059|NCT01038635|E2|Reported Event|5-AZA + LEN 15 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
249060|NCT01038635|E1|Reported Event|5-AZA + LEN 10 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
249061|NCT01038609|B6|Baseline|Total|Total of all reporting groups
249062|NCT01038609|B5|Baseline|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249063|NCT01038609|B4|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249064|NCT01038609|B3|Baseline|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249065|NCT01038609|B2|Baseline|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249066|NCT01038609|B1|Baseline|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249067|NCT01038609|P5|Participant Flow|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249068|NCT01038609|P4|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249069|NCT01038609|P3|Participant Flow|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249070|NCT01038609|P2|Participant Flow|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249071|NCT01038609|P1|Participant Flow|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249072|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249258|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249259|NCT01037244|O4|Outcome|Placebo|Placebo tablets
249073|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249074|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249075|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249076|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249077|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249078|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249079|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249080|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249081|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249082|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249083|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249084|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249085|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249086|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249087|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249088|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249089|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249090|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249091|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249092|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249093|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249094|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249095|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249096|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249097|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249098|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249099|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249100|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249101|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249102|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249103|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249104|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249105|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249106|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249107|NCT01038609|E5|Reported Event|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249108|NCT01038609|E4|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249109|NCT01038609|E3|Reported Event|Morphine Extended Release/Acetaminophen|1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249110|NCT01038609|E2|Reported Event|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
249111|NCT01038609|E1|Reported Event|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
249112|NCT01038336|B4|Baseline|Total|Total of all reporting groups
249113|NCT01038336|B3|Baseline|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249114|NCT01038336|B2|Baseline|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249115|NCT01038336|B1|Baseline|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249116|NCT01038336|P3|Participant Flow|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249117|NCT01038336|P2|Participant Flow|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249118|NCT01038336|P1|Participant Flow|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249119|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249120|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249260|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249121|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249122|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249123|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249124|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249125|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249126|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249127|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249128|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249129|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249130|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249131|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): Soc amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
249132|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249133|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249134|NCT01038336|O3|Outcome|Standard of Care|Standard of care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to.
249135|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249136|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249137|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
249138|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249139|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249140|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
249141|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
249142|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
249143|NCT01038336|E3|Reported Event|Standard of Care|Standard of Care (SoC): SoC amounts ot no intervention although participants were allowed to seek information about hearing loss prevention if they wanted to.
249144|NCT01038336|E2|Reported Event|Hearing Conservation Brochure|Hearing Conservation Brochure (HCB). Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
249145|NCT01038336|E1|Reported Event|Multimedia Hearing Loss Prevention Program|Multimedia Hearing Loss Prevention Program (HLPP) is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
249146|NCT01038323|B4|Baseline|Total|Total of all reporting groups
249147|NCT01038323|B3|Baseline|Cognitive Behavioral Therapy|Subjects received 8 telephone-delivered cognitive behavioral therapy (CBT), and placebo BID (x 20 weeks)
249148|NCT01038323|B2|Baseline|Milnacipran Monotherapy|Subjects received milnacipran 50 mg BID (x 20 weeks) and 8 telephone delivered education sessions
249149|NCT01038323|B1|Baseline|Combination|Subjects received both 8 telephone-delivered cognitive behavioral therapy (CBT), and milnacipran 50 mg BID (x 20 weeks)
249150|NCT01038323|P3|Participant Flow|Cognitive Monotherapy|Cognitive behavioral therapy
249153|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Subjects received 8 telephone-delivered cognitive behavioral therapy (CBT), and placebo BID (x 20 weeks)
249154|NCT01038323|O2|Outcome|Milnacipran Monotherapy|Subjects received milnacipran 50 mg BID (x 20 weeks) and 8 telephone delivered education sessions
249155|NCT01038323|O1|Outcome|Combination|Subjects received both 8 telephone-delivered cognitive behavioral therapy (CBT), and milnacipran 50 mg BID (x 20 weeks)
249156|NCT01038323|O3|Outcome|Cognitive Monotherapy|Cognitive behavioral therapy
249157|NCT01038323|O2|Outcome|Milnacipran|drug monotherapy
249158|NCT01038323|O1|Outcome|Combination|milnacipran and CBT
249159|NCT01038323|E3|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy + placebo
249160|NCT01038323|E2|Reported Event|Milnacipran|milnacipran + education
249161|NCT01038323|E1|Reported Event|Combination|Cognitive behavioral therapy + milnacipran
249162|NCT01038128|B1|Baseline|Memantine|Memantine, 10-40 mg daily
249163|NCT01038128|P1|Participant Flow|Memantine|Memantine, 10-40 mg daily
249164|NCT01038128|O1|Outcome|Baseline Data|Ratings at Baseline and Endpoint.
249165|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
249166|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
249167|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
249168|NCT01038128|O1|Outcome|Memantine|Number of Binge Eating and Purging Episodes at Baseline and Endpoint
249169|NCT01038128|E1|Reported Event|Memantine|Memantine, 10-40 mg daily
249170|NCT01037452|B5|Baseline|Total|Total of all reporting groups
249171|NCT01037452|B4|Baseline|Placebo|Placebo, single dose
249172|NCT01037452|B3|Baseline|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249173|NCT01037452|B2|Baseline|PPI Alone|Lansoprazole 15 mg, single dose
249174|NCT01037452|B1|Baseline|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249175|NCT01037452|P4|Participant Flow|Placebo|Placebo, single dose
249176|NCT01037452|P3|Participant Flow|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249177|NCT01037452|P2|Participant Flow|PPI Alone|Lansoprazole 15 mg, single dose
249178|NCT01037452|P1|Participant Flow|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249179|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
249180|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249181|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
249182|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249183|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
249184|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249185|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
249186|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249187|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
249188|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249189|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
249190|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249191|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
249192|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249193|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
249194|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249195|NCT01037452|E4|Reported Event|Placebo|Placebo, single dose
249196|NCT01037452|E3|Reported Event|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
249197|NCT01037452|E2|Reported Event|PPI Alone|Lansoprazole 15 mg, single dose
249198|NCT01037452|E1|Reported Event|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
249199|NCT01037309|B7|Baseline|Total|Total of all reporting groups
249200|NCT01037309|B6|Baseline|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249201|NCT01037309|B5|Baseline|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249202|NCT01037309|B4|Baseline|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249203|NCT01037309|B3|Baseline|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249204|NCT01037309|B2|Baseline|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249205|NCT01037309|B1|Baseline|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249206|NCT01037309|P9|Participant Flow|Intravenous PRO044 8 mg/kg|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249207|NCT01037309|P8|Participant Flow|Intravenous PRO044 5 mg/kg|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249208|NCT01037309|P7|Participant Flow|Intravenous PRO044 1.5 mg/kg|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249209|NCT01037309|P6|Participant Flow|Subcutaneous PRO044 12 mg/kg|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249210|NCT01037309|P5|Participant Flow|Subcutaneous PRO044 10 mg/kg|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249261|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249211|NCT01037309|P4|Participant Flow|Subcutaneous PRO044 8 mg/kg|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249212|NCT01037309|P3|Participant Flow|Subcutaneous PRO044 5 mg/kg|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249213|NCT01037309|P2|Participant Flow|Subcutaneous PRO044 1.5 mg/kg|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249214|NCT01037309|P1|Participant Flow|Subcutaneous PRO044 0.5 mg/kg|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249215|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249216|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249217|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249218|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249219|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249220|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249221|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249222|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249223|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249224|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249225|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249226|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249227|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249228|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249229|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249230|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249231|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249232|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249233|NCT01037309|E9|Reported Event|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249234|NCT01037309|E8|Reported Event|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249235|NCT01037309|E7|Reported Event|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
249236|NCT01037309|E6|Reported Event|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249237|NCT01037309|E5|Reported Event|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249238|NCT01037309|E4|Reported Event|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249239|NCT01037309|E3|Reported Event|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249240|NCT01037309|E2|Reported Event|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249241|NCT01037309|E1|Reported Event|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
249242|NCT01037244|B5|Baseline|Total|Total of all reporting groups
249243|NCT01037244|B4|Baseline|Placebo|Placebo tablets
249244|NCT01037244|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
249245|NCT01037244|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
249246|NCT01037244|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
249247|NCT01037244|P4|Participant Flow|Placebo|Placebo tablets
249248|NCT01037244|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
249249|NCT01037244|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
249250|NCT01037244|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
249251|NCT01037244|O4|Outcome|Placebo|Placebo tablets
249252|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249253|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249254|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249255|NCT01037244|O4|Outcome|Placebo|Placebo tablets
249256|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249313|NCT01037218|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
249314|NCT01037218|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
249315|NCT01037218|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
249316|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249317|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249318|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249319|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249320|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249321|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249322|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249323|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249324|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249325|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249326|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249327|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249328|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249329|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249330|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249331|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249332|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249333|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249334|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249335|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249336|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249337|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249338|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249339|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249340|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249341|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249342|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249343|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249344|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249345|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249346|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249347|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249348|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249349|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249350|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249351|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249352|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249353|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249354|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249355|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249356|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249357|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249358|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249359|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249360|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249361|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249362|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249363|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249364|NCT01037218|O4|Outcome|Placebo|Placebo tablets
249365|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
249366|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
249367|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
249368|NCT01037218|E4|Reported Event|Placebo|Placebo tablets
249369|NCT01037218|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
249370|NCT01037218|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
249371|NCT01037218|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
249372|NCT01037192|B3|Baseline|Total|Total of all reporting groups
249373|NCT01037192|B2|Baseline|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
249374|NCT01037192|B1|Baseline|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
249375|NCT01037192|P2|Participant Flow|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
249376|NCT01037192|P1|Participant Flow|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
249377|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
249378|NCT01037192|O1|Outcome|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
249379|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Vancomycin 15 mg/kg IV twice daily
249380|NCT01037192|O1|Outcome|Vancomycin Once Daily|Vancomycin 30 mg/kg IV daily
249381|NCT01037192|E2|Reported Event|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
249382|NCT01037192|E1|Reported Event|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
249383|NCT01037127|B3|Baseline|Total|Total of all reporting groups
249384|NCT01037127|B2|Baseline|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249385|NCT01037127|B1|Baseline|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249386|NCT01037127|P2|Participant Flow|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249387|NCT01037127|P1|Participant Flow|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib (GSK1120212) 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249388|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249389|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249390|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249391|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249392|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249475|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
249476|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
254477|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
249393|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249394|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249395|NCT01037127|O4|Outcome|Paticipants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249396|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249397|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249398|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249399|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249400|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249401|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249402|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249403|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249477|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
249478|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
249479|NCT01036724|E2|Reported Event|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
254657|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
249404|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249405|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249406|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249407|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249408|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249409|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with a positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249410|NCT01037127|O4|Outcome|Participants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with a positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249411|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with a positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249412|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis, who were previoulsy treated with standard thearpy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249413|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis, who were previously treated with standard therapy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
249414|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249480|NCT01036724|E1|Reported Event|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
249481|NCT01036529|B3|Baseline|Total|Total of all reporting groups
249482|NCT01036529|B2|Baseline|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
254725|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
249415|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249416|NCT01037127|E2|Reported Event|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249417|NCT01037127|E1|Reported Event|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
249418|NCT01037114|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249419|NCT01037114|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249420|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249421|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249422|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249423|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249424|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249425|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249426|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249483|NCT01036529|B1|Baseline|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
249484|NCT01036529|P2|Participant Flow|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
249485|NCT01036529|P1|Participant Flow|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulator Intervention
249427|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249428|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249429|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249430|NCT01037114|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
249431|NCT01037088|B1|Baseline|All Participants|All participants who were randomized
249432|NCT01037088|P1|Participant Flow|All Participants|All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
249433|NCT01037088|O3|Outcome|Placebo Cannabis|trace THC by weight
249434|NCT01037088|O2|Outcome|Low Dose Cannabis|1.29% THC by weight
249435|NCT01037088|O1|Outcome|Mild Dose Cannabis|3.53% THC by weight
249436|NCT01037088|E3|Reported Event|Placebo Cannabis|0% 9-delta tetrahydrocannabinol by weight
249437|NCT01037088|E2|Reported Event|Low Dose Cannabis|1.29% 9-delta tetrahydrocannabinol by weight
249438|NCT01037088|E1|Reported Event|Mild Dose Cannabis|3.53% 9-delta tetrahydrocannabinol by weight
249439|NCT01036802|B3|Baseline|Total|Total of all reporting groups
249440|NCT01036802|B2|Baseline|Placebo|Patients were randomized to placebo
249441|NCT01036802|B1|Baseline|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249442|NCT01036802|P2|Participant Flow|Placebo|Patients were randomized to placebo
249443|NCT01036802|P1|Participant Flow|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249444|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249445|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249446|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249447|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249448|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249449|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249450|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249451|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249452|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249453|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249454|NCT01036802|O2|Outcome|Placebo|Patients were on placebo
249455|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249456|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
249457|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249458|NCT01036802|E2|Reported Event|Placebo|Patients were randomized to placebo
249459|NCT01036802|E1|Reported Event|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
249460|NCT01036763|B1|Baseline|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249461|NCT01036763|P1|Participant Flow|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249462|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249463|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249464|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249465|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249466|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249467|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249468|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249469|NCT01036763|E1|Reported Event|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
249470|NCT01036724|B3|Baseline|Total|Total of all reporting groups
249471|NCT01036724|B2|Baseline|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
249472|NCT01036724|B1|Baseline|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
249473|NCT01036724|P2|Participant Flow|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
249474|NCT01036724|P1|Participant Flow|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
254855|NCT01019928|O2|Outcome|Placebo|
249486|NCT01036529|O2|Outcome|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
249487|NCT01036529|O1|Outcome|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
249488|NCT01036529|E2|Reported Event|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
249489|NCT01036529|E1|Reported Event|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
249490|NCT01036490|B3|Baseline|Total|Total of all reporting groups
249491|NCT01036490|B2|Baseline|Control|Nutritional counseling alone
249492|NCT01036490|B1|Baseline|Exercise|12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling
249493|NCT01036490|P2|Participant Flow|Control|Dietary management alone
249494|NCT01036490|P1|Participant Flow|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249495|NCT01036490|O2|Outcome|Control|Dietary management alone
249496|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249497|NCT01036490|O2|Outcome|Control|Dietary management alone
249498|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249499|NCT01036490|O2|Outcome|Control|Dietary management alone
249500|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249501|NCT01036490|O2|Outcome|Control|Dietary management alone
249502|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249503|NCT01036490|O2|Outcome|Control|Dietary management alone
249504|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249505|NCT01036490|O2|Outcome|Control|Dietary management alone
249506|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249507|NCT01036490|E2|Reported Event|Control|Dietary management alone
249508|NCT01036490|E1|Reported Event|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
249509|NCT01036438|B3|Baseline|Total|Total of all reporting groups
249510|NCT01036438|B2|Baseline|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249511|NCT01036438|B1|Baseline|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249512|NCT01036438|P2|Participant Flow|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249513|NCT01036438|P1|Participant Flow|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249514|NCT01036438|O2|Outcome|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249515|NCT01036438|O1|Outcome|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249516|NCT01036438|E2|Reported Event|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249517|NCT01036438|E1|Reported Event|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
249518|NCT01036321|B3|Baseline|Total|Total of all reporting groups
249519|NCT01036321|B2|Baseline|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249520|NCT01036321|B1|Baseline|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249521|NCT01036321|P2|Participant Flow|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249522|NCT01036321|P1|Participant Flow|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249523|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249524|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249525|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249526|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249527|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249528|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249529|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249530|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249531|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249532|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249533|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249534|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249535|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249536|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249537|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249538|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249539|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249540|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249541|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249542|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249543|NCT01036321|E2|Reported Event|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
249544|NCT01036321|E1|Reported Event|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
249545|NCT01036165|B1|Baseline|Subject Disposition|Intent-to-Treat Analysis
249546|NCT01036165|P1|Participant Flow|Subject Disposition|Intent-to-Treat Analysis
249547|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
249548|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
249549|NCT01036165|E1|Reported Event|Subject Disposition|Intent-to-Treat Analysis
249550|NCT01036009|B3|Baseline|Total|Total of all reporting groups
249551|NCT01036009|B2|Baseline|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249552|NCT01036009|B1|Baseline|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249553|NCT01036009|P2|Participant Flow|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249554|NCT01036009|P1|Participant Flow|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249555|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249556|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249557|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249558|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249559|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249560|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249561|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249759|NCT01035346|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249562|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249563|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249564|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249565|NCT01036009|E2|Reported Event|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
249566|NCT01036009|E1|Reported Event|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
249567|NCT01035944|B5|Baseline|Total|Total of all reporting groups
249568|NCT01035944|B4|Baseline|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249569|NCT01035944|B3|Baseline|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249570|NCT01035944|B2|Baseline|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249571|NCT01035944|B1|Baseline|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249572|NCT01035944|P4|Participant Flow|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249573|NCT01035944|P3|Participant Flow|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249574|NCT01035944|P2|Participant Flow|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249575|NCT01035944|P1|Participant Flow|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249576|NCT01035944|O4|Outcome|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249577|NCT01035944|O3|Outcome|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
254856|NCT01019928|O1|Outcome|AZD1386 95 mg|
249578|NCT01035944|O2|Outcome|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249579|NCT01035944|O1|Outcome|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249580|NCT01035944|E4|Reported Event|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249581|NCT01035944|E3|Reported Event|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249582|NCT01035944|E2|Reported Event|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
249583|NCT01035944|E1|Reported Event|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
249584|NCT01035905|B3|Baseline|Total|Total of all reporting groups
249585|NCT01035905|B2|Baseline|Narafilcon A|Narafilcon A contact lens
249586|NCT01035905|B1|Baseline|Nelfilcon A|Nelfilcon A contact lens
249587|NCT01035905|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
249588|NCT01035905|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
249589|NCT01035905|O2|Outcome|Narafilcon A|Narafilcon A contact lens
249590|NCT01035905|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
249591|NCT01035905|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
249592|NCT01035905|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
249593|NCT01035788|B3|Baseline|Total|Total of all reporting groups
249594|NCT01035788|B2|Baseline|Cognitive Behavioral Conjoint Therapy Communication Skills|"Psychoeducational Intervention~Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD."
249595|NCT01035788|B1|Baseline|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
249596|NCT01035788|P2|Participant Flow|Cognitive Behavioral Conjoint Therapy Communication Skills|Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
249597|NCT01035788|P1|Participant Flow|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
249598|NCT01035788|O2|Outcome|Cognitive Behavioral Conjoint Therapy Communication Skills|"Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills~This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
249599|NCT01035788|O1|Outcome|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
249600|NCT01035788|E2|Reported Event|Cognitive Behavioral Conjoint Therapy Communication Skills|"CBCT for PTSD - Communication Skills~CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
249760|NCT01035346|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249601|NCT01035788|E1|Reported Event|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy: This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
249602|NCT01035749|B5|Baseline|Total|Total of all reporting groups
249603|NCT01035749|B4|Baseline|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249604|NCT01035749|B3|Baseline|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249605|NCT01035749|B2|Baseline|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249606|NCT01035749|B1|Baseline|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249607|NCT01035749|P4|Participant Flow|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249608|NCT01035749|P3|Participant Flow|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249609|NCT01035749|P2|Participant Flow|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249610|NCT01035749|P1|Participant Flow|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249611|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249612|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249613|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249614|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249615|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249616|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249617|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249618|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249619|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249620|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249621|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249622|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249623|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249624|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249625|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249626|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249627|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249628|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249629|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249630|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249631|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249632|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249668|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249633|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249634|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249635|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249636|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249637|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249638|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249639|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249640|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249641|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249642|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249643|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249644|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249645|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249646|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249647|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249648|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249649|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249650|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249651|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249652|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249653|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249654|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249655|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249656|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249657|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249658|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249659|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249660|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249661|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249662|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249663|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249664|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249665|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249666|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249667|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249669|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249670|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249671|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249672|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249673|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249674|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249675|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249676|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249677|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249678|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249679|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249680|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249681|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249682|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249683|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249684|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249685|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249686|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249687|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249688|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249689|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249690|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249691|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249692|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249693|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249694|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249695|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249696|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249697|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249698|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249699|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249700|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249701|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249702|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249703|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249704|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249705|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249706|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249707|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249708|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249709|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249710|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249711|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249712|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249713|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249714|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249715|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249716|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249717|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249718|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249719|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249720|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249721|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249722|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249723|NCT01035749|E4|Reported Event|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249724|NCT01035749|E3|Reported Event|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
249725|NCT01035749|E2|Reported Event|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249726|NCT01035749|E1|Reported Event|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
249727|NCT01035658|B5|Baseline|Total|Total of all reporting groups
249728|NCT01035658|B4|Baseline|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249729|NCT01035658|B3|Baseline|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249730|NCT01035658|B2|Baseline|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249731|NCT01035658|B1|Baseline|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
254857|NCT01019928|O2|Outcome|Placebo|
249732|NCT01035658|P4|Participant Flow|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249733|NCT01035658|P3|Participant Flow|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249734|NCT01035658|P2|Participant Flow|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249735|NCT01035658|P1|Participant Flow|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249736|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249737|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249738|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249739|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249740|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249741|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249742|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249743|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249758|NCT01035346|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249744|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249745|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249746|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249747|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249748|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249749|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249750|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249751|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249752|NCT01035658|O1|Outcome|Phase 1|All patients in Phase I (this section contains the Maximum Tolerated Dose)
249753|NCT01035658|E4|Reported Event|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249754|NCT01035658|E3|Reported Event|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249755|NCT01035658|E2|Reported Event|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249756|NCT01035658|E1|Reported Event|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
249757|NCT01035346|B3|Baseline|Total|Total of all reporting groups
249761|NCT01035346|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
249762|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249763|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249764|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249765|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249766|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249767|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249768|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249769|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249770|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249771|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249772|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249773|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249774|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249775|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249776|NCT01035346|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
249777|NCT01035346|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
249778|NCT01035333|B1|Baseline|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
249779|NCT01035333|P1|Participant Flow|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
249780|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
249781|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
249782|NCT01035333|E1|Reported Event|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
249783|NCT01035255|B3|Baseline|Total|Total of all reporting groups
249784|NCT01035255|B2|Baseline|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249785|NCT01035255|B1|Baseline|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249786|NCT01035255|P2|Participant Flow|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249787|NCT01035255|P1|Participant Flow|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249788|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249789|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249790|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249791|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249894|NCT01035047|P2|Participant Flow|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
250406|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
249792|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249793|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249794|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249795|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249796|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249797|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249798|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249799|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249800|NCT01035255|E2|Reported Event|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
249801|NCT01035255|E1|Reported Event|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
249802|NCT01035229|B3|Baseline|Total|Total of all reporting groups
249803|NCT01035229|B2|Baseline|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249804|NCT01035229|B1|Baseline|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249805|NCT01035229|P2|Participant Flow|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249806|NCT01035229|P1|Participant Flow|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249807|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
249808|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
250173|NCT01034358|O1|Outcome|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
249809|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
249810|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249811|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249812|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249813|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249814|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249815|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249816|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249817|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249818|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249819|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249820|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249821|NCT01035229|E2|Reported Event|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
249822|NCT01035229|E1|Reported Event|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
249823|NCT01035138|B4|Baseline|Total|Total of all reporting groups
249824|NCT01035138|B3|Baseline|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249825|NCT01035138|B2|Baseline|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249826|NCT01035138|B1|Baseline|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249827|NCT01035138|P3|Participant Flow|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
249828|NCT01035138|P2|Participant Flow|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 (LY 100 mg) orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
249829|NCT01035138|P1|Participant Flow|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249830|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249831|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
250028|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
249832|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249833|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249834|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249835|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249836|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249837|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249838|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249839|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249840|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249841|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249842|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249843|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249844|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249845|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249846|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249847|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249848|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249849|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249850|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249851|NCT01035138|O1|Outcome|LY 140 mg|Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)
249852|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249853|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249854|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249855|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249856|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249857|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249858|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249859|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
250142|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
249860|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249861|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249862|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249863|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249864|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249865|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249866|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249867|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249868|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249869|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249870|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249871|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249872|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249873|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249874|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249875|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249876|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249877|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249878|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249879|NCT01035138|E3|Reported Event|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249880|NCT01035138|E2|Reported Event|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
249881|NCT01035138|E1|Reported Event|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
249882|NCT01035060|B3|Baseline|Total|Total of all reporting groups
249883|NCT01035060|B2|Baseline|Young Adults|
249884|NCT01035060|B1|Baseline|Older Adults|
249885|NCT01035060|P2|Participant Flow|Young Adults|Persons aged 18-30 years
249886|NCT01035060|P1|Participant Flow|Older Adults|Persons aged ≥ 70 years
249887|NCT01035060|O2|Outcome|Young Adults|Age 18-35 years
249888|NCT01035060|O1|Outcome|Older Adults|Age > 70 years
249889|NCT01035060|E2|Reported Event|Older Adults|
249890|NCT01035060|E1|Reported Event|Younger Adults|
249891|NCT01035047|B3|Baseline|Total|Total of all reporting groups
249892|NCT01035047|B2|Baseline|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249893|NCT01035047|B1|Baseline|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
250466|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
249895|NCT01035047|P1|Participant Flow|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249896|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249897|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249898|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249899|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249900|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249901|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249902|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249903|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249904|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249905|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249906|NCT01035047|E2|Reported Event|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
249907|NCT01035047|E1|Reported Event|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
249908|NCT01034709|B3|Baseline|Total|Total of all reporting groups
249909|NCT01034709|B2|Baseline|Asymptomatic|Subjects who are serologically negative for CMV IgG
249910|NCT01034709|B1|Baseline|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
249911|NCT01034709|P2|Participant Flow|Asymptomatic|Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
249912|NCT01034709|P1|Participant Flow|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
249913|NCT01034709|O2|Outcome|Asymptomatic|Subjects who are serologically negative for CMV IgG
249914|NCT01034709|O1|Outcome|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
249915|NCT01034709|E2|Reported Event|Asymptomatic|Subjects who are serologically negative for CMV IgG
249916|NCT01034709|E1|Reported Event|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
249917|NCT01034657|B1|Baseline|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249918|NCT01034657|P3|Participant Flow|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249919|NCT01034657|P2|Participant Flow|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249920|NCT01034657|P1|Participant Flow|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249921|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249922|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249923|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249924|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249925|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249926|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249927|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249928|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249929|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249930|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249931|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249932|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249933|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249934|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249935|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249936|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249937|NCT01034657|O3|Outcome|Not Randomized|
249938|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249939|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249940|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249941|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249942|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249943|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249944|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249945|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249946|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249947|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249948|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249949|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249950|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249951|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249952|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249953|NCT01034657|E4|Reported Event|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
249954|NCT01034657|E3|Reported Event|LBH589 + ESA - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249955|NCT01034657|E2|Reported Event|LBH589 - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
249956|NCT01034657|E1|Reported Event|LBH589 - Core Phase|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
249957|NCT01034592|B1|Baseline|Baseline Measures|This is an open-label study. Active drug will be administered to all participants at a dosing regimen of 2.5 mg of lenalidomide weekly on days 1-21 every 28 days up to 5mg thrice weekly on days 1-21 every 28 days.
249958|NCT01034592|P1|Participant Flow|Lenalidomide|2.5 mg weekly as oral tablets during days 1-21 of cycle 1 (dose level 1). If no toxicity ≥3 dose will be increased to 2.5mg twice weekly on days 1-21 of cycle 2 (dose level 2). If no toxicity ≥3 dose will be increased to 5mg twice weekly on days 1-21 of cycle 3 (dose level 3). If no toxicity ≥3 dose will be increased to 5mg thrice weekly on days 1-21 of cycle 4 (dose level 4).
249959|NCT01034592|O1|Outcome|Measured Values|RBC transfusion independence
249960|NCT01034592|E1|Reported Event|Serious Adverse Events|Serious Adverse Events include: adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
249961|NCT01034579|B3|Baseline|Total|Total of all reporting groups
249962|NCT01034579|B2|Baseline|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249963|NCT01034579|B1|Baseline|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249964|NCT01034579|P2|Participant Flow|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249965|NCT01034579|P1|Participant Flow|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249966|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249967|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
250403|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
249968|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249969|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249970|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249971|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249972|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249973|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249974|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249975|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249976|NCT01034579|E2|Reported Event|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249977|NCT01034579|E1|Reported Event|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
249978|NCT01034553|B1|Baseline|All Patients|"All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.~Aurora A kinase inhibitor MLN8237: Given orally"
249979|NCT01034553|P6|Participant Flow|Phase II, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249980|NCT01034553|P5|Participant Flow|Phase I, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
249981|NCT01034553|P4|Participant Flow|Phase I, Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
249982|NCT01034553|P3|Participant Flow|Phase I, Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
249983|NCT01034553|P2|Participant Flow|Phase I, Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
249984|NCT01034553|P1|Participant Flow|Phase I, Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
249985|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 and bortezomib IV. >~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249986|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249987|NCT01034553|O4|Outcome|Dose Level 3|Patients received 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
249988|NCT01034553|O3|Outcome|Dose Level 2|Patients received 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
249989|NCT01034553|O2|Outcome|Dose Level 1|Patients received 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
249990|NCT01034553|O1|Outcome|Dose Level 0|This includes patients who received 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. As well as, patients who received 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
249991|NCT01034553|O5|Outcome|Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249992|NCT01034553|O4|Outcome|Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
250143|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
249993|NCT01034553|O3|Outcome|Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249994|NCT01034553|O2|Outcome|Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249995|NCT01034553|O1|Outcome|Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
249996|NCT01034553|E1|Reported Event|All Patients|bortezomib: Given IV
249997|NCT01034540|B3|Baseline|Total|Total of all reporting groups
249998|NCT01034540|B2|Baseline|Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3)|Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
249999|NCT01034540|B1|Baseline|Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo|POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
250000|NCT01034540|P2|Participant Flow|Placebo/Prescription Omega-3 Acid Ethyl Esters|Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
250001|NCT01034540|P1|Participant Flow|Prescription Omega-3 Acid Ethyl Esters/Placebo|Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment
250002|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
250003|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
250004|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
250005|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
250006|NCT01034540|E2|Reported Event|Placebo|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
250007|NCT01034540|E1|Reported Event|POM3|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
250008|NCT01034462|B3|Baseline|Total|Total of all reporting groups
250009|NCT01034462|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
250010|NCT01034462|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
250011|NCT01034462|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
250012|NCT01034462|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
250013|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
250014|NCT01034462|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
250015|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
250016|NCT01034462|O1|Outcome|Placebo|"Matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."
250017|NCT01034462|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
250018|NCT01034462|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
250019|NCT01034397|B3|Baseline|Total|Total of all reporting groups
250020|NCT01034397|B2|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks.
250021|NCT01034397|B1|Baseline|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
250022|NCT01034397|P2|Participant Flow|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of greater than or equal to [≥]20 percent [%] in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
250023|NCT01034397|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) intravenously (IV) once every 4 weeks for 24 weeks.
250024|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250025|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250026|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250027|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250029|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250030|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250031|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250032|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250033|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250034|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250035|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250036|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250037|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250038|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250039|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250040|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250041|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250042|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250043|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250044|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.
250045|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250046|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250047|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250048|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250049|NCT01034397|O3|Outcome|Placebo-Tocilizumab|At 12 Weeks participants who did not show an improvement of ≥20% in tender and swollen joint counts were offered a rescue therapy with open-label tocilizumab 8mg/kg every 4 weeks
250050|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of at least 20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks.
250051|NCT01034397|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks
250052|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250053|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250054|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250055|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250056|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
254858|NCT01019928|O1|Outcome|AZD1386 95 mg|
250057|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250058|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250059|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250060|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250061|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250062|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250063|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250064|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250065|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250066|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250067|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250068|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250069|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250070|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250071|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250072|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250073|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250074|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250075|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250076|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250077|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250078|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250079|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250080|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250081|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250082|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250083|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250084|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250172|NCT01034358|P1|Participant Flow|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
250404|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250085|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250086|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250087|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250088|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250089|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250090|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250091|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250092|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250093|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250094|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250095|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250096|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250097|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250098|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for a 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250099|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250100|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250101|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250102|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250103|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250104|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250105|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250106|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250107|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250108|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250109|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250110|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250111|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250112|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250113|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250405|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250114|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250115|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250116|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250117|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250118|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250119|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250120|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250121|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250122|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250123|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250124|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250125|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250126|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250127|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250128|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250129|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250130|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250131|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250132|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250133|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250134|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250135|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250136|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250137|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250138|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250139|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250140|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250141|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
254859|NCT01019928|O2|Outcome|Placebo|
250144|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250145|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250146|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250147|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250148|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250149|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250150|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250151|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250152|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250153|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250154|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250155|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250156|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250157|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250158|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250159|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250160|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
250161|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250162|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250163|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250164|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250165|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250166|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count [TJC] and swollen joint count [SJC]) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250167|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250168|NCT01034397|E3|Reported Event|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250169|NCT01034397|E2|Reported Event|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
250170|NCT01034397|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
250171|NCT01034358|B1|Baseline|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
250174|NCT01034358|E1|Reported Event|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
250175|NCT01034306|B3|Baseline|Total|Total of all reporting groups
250176|NCT01034306|B2|Baseline|Placebo|MAtching placebo q12 for 12 weeks
250177|NCT01034306|B1|Baseline|CF101 1mg|CF101 1mg q12 for 12 weeks
250178|NCT01034306|P2|Participant Flow|Placebo|Matching placebo q12 for 12 weeks
250179|NCT01034306|P1|Participant Flow|CF101 1mg|CF101 1mg q12 for 12 weeks
250180|NCT01034306|O2|Outcome|Placebo|Matching placebo q12 for 12 weeks
250181|NCT01034306|O1|Outcome|CF101 1mg|CF101 1mg q12 for 12 weeks
250182|NCT01034306|E2|Reported Event|Placebo|Matching placebo q12 for 12 weeks
250183|NCT01034306|E1|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
250184|NCT01034163|B3|Baseline|Total|Total of all reporting groups
250185|NCT01034163|B2|Baseline|Placebo|Participants received matching placebo to PAN TIW, QOW.
250186|NCT01034163|B1|Baseline|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
250187|NCT01034163|P2|Participant Flow|Placebo|Participants received matching placebo to PAN TIW, QOW.
250188|NCT01034163|P1|Participant Flow|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
250189|NCT01034163|O2|Outcome|Placebo|Participants received matching placebo to PAN TIW, QOW.
250190|NCT01034163|O1|Outcome|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
250191|NCT01034163|E2|Reported Event|Placebo|Participants received matching placebo to PAN TIW, QOW.
250192|NCT01034163|E1|Reported Event|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
250193|NCT01034137|B4|Baseline|Total|Total of all reporting groups
250194|NCT01034137|B3|Baseline|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250195|NCT01034137|B2|Baseline|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250196|NCT01034137|B1|Baseline|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250197|NCT01034137|P3|Participant Flow|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250198|NCT01034137|P2|Participant Flow|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250199|NCT01034137|P1|Participant Flow|Tocilizumab + Methotrexate|Participants received intravenous (IV) Tocilizumab (TCZ) 8 milligram (mg)/kilogram (kg) every four weeks for a maximum of 26 infusions + oral capsules of Methotrexate (MTX) 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250200|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250201|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250202|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250203|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250204|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250205|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250206|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250207|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250208|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250356|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
254860|NCT01019928|O1|Outcome|AZD1386 95 mg|
250209|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250210|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250211|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250212|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250213|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250214|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250215|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250216|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250217|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250218|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250219|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250220|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250221|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250222|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250223|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250224|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250225|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250226|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250227|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250228|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250229|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250230|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250357|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
254861|NCT01019928|O2|Outcome|Placebo|
250231|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250232|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250233|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250234|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250235|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250236|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250237|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250238|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250239|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250240|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250241|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250242|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250243|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250244|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250245|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250246|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250247|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250248|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250249|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250250|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250251|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250252|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250297|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250253|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250254|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250255|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250256|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250257|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250258|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250259|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250260|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250261|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250262|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250263|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250264|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250265|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250266|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250267|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250268|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250269|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250270|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250271|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250272|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250273|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250274|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250353|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
254862|NCT01019928|O1|Outcome|AZD1386 95 mg|
250275|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250276|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250277|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250278|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250279|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250280|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250281|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250282|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250283|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250284|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250285|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250286|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250287|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250288|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250289|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250290|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250291|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250292|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250293|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250294|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250295|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250296|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250354|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
254863|NCT01019928|O2|Outcome|Placebo|
250298|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250299|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250300|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250301|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250302|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250303|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250304|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250305|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250306|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250307|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250308|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250309|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250310|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250311|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week
250312|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250313|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250314|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250315|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250316|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250317|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250318|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250319|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250355|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
254864|NCT01019928|O1|Outcome|AZD1386 95 mg|
250320|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250321|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250322|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250323|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250324|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250325|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250326|NCT01034137|E3|Reported Event|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
250327|NCT01034137|E2|Reported Event|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
250328|NCT01034137|E1|Reported Event|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
250329|NCT01034111|B1|Baseline|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
250330|NCT01034111|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
250331|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
250332|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
250333|NCT01034111|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
250334|NCT01033864|B3|Baseline|Total|Total of all reporting groups
250335|NCT01033864|B2|Baseline|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250336|NCT01033864|B1|Baseline|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250337|NCT01033864|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250338|NCT01033864|P1|Participant Flow|Mycophenolate Mofetil (MMF)/Prednisone|Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
250339|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250340|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250341|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250342|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250343|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250344|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250345|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250346|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250347|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250348|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250349|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250350|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250351|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250352|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250358|NCT01033864|E2|Reported Event|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250359|NCT01033864|E1|Reported Event|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
250360|NCT01033851|B3|Baseline|Total|Total of all reporting groups
250361|NCT01033851|B2|Baseline|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
250362|NCT01033851|B1|Baseline|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
250363|NCT01033851|P2|Participant Flow|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
250364|NCT01033851|P1|Participant Flow|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
250365|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
250366|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
250367|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
250368|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
250369|NCT01033851|E2|Reported Event|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
250370|NCT01033851|E1|Reported Event|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
250371|NCT01033825|B8|Baseline|Total|Total of all reporting groups
250372|NCT01033825|B7|Baseline|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
250373|NCT01033825|B6|Baseline|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
250374|NCT01033825|B5|Baseline|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250375|NCT01033825|B4|Baseline|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250376|NCT01033825|B3|Baseline|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250377|NCT01033825|B2|Baseline|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250378|NCT01033825|B1|Baseline|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250379|NCT01033825|P7|Participant Flow|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
250380|NCT01033825|P6|Participant Flow|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
250381|NCT01033825|P5|Participant Flow|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250382|NCT01033825|P4|Participant Flow|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250383|NCT01033825|P3|Participant Flow|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250384|NCT01033825|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250385|NCT01033825|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250386|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250387|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250388|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250389|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250390|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250391|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250392|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250393|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250394|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250395|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250396|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250397|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250398|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250399|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250400|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250401|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250402|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250407|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250408|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250409|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250410|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250411|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250412|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250413|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250414|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250415|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250416|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250417|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250418|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250419|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250420|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250421|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250422|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250423|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250424|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250425|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250426|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250427|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250428|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250429|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250430|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250431|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250432|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250433|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250434|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250435|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250436|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250437|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250438|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250439|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250440|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250441|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250442|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250443|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250444|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250445|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250446|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250447|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250448|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250449|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
250450|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
250451|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250452|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250453|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
250454|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250455|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250456|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250457|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250458|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250459|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250460|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250461|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250462|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250463|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250464|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250465|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250467|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250468|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250469|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250470|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250471|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250472|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250473|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250474|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250475|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250476|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250477|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250478|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250479|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250480|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250481|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250482|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250483|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250484|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250485|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250486|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250487|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250488|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250489|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250490|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250491|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250492|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250493|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250494|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250495|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250496|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250497|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250498|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250499|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250500|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250501|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250502|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250503|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250504|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250505|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250506|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250507|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250508|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250509|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250510|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250511|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250512|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250513|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250514|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250515|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250516|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250517|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250518|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250519|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250520|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250521|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250522|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250523|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250524|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250525|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
254865|NCT01019928|O2|Outcome|Placebo|
250526|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250527|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250528|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250529|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250530|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250531|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250532|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250533|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250534|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250535|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250536|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250537|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250538|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250539|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250540|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250541|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250542|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250543|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250544|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250545|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250546|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250547|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250548|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250549|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
250550|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
250551|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250552|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250553|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250554|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250555|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250556|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
250557|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
250558|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250559|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250560|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250561|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250562|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250563|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250564|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250565|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250566|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250567|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250568|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250569|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250570|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250571|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250572|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250573|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250574|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250575|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250576|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250577|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250578|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250579|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250580|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250581|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250582|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250583|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250584|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250585|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250586|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250587|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250588|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
250589|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250590|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250591|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250592|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250593|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
250594|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
250595|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250596|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250597|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
250598|NCT01033825|E5|Reported Event|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
250599|NCT01033825|E4|Reported Event|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
250600|NCT01033825|E3|Reported Event|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
250601|NCT01033825|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
250602|NCT01033825|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
250603|NCT01033747|B3|Baseline|Total|Total of all reporting groups
250604|NCT01033747|B2|Baseline|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
250605|NCT01033747|B1|Baseline|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
250606|NCT01033747|P2|Participant Flow|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
250607|NCT01033747|P1|Participant Flow|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
250608|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
250609|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
250610|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
250611|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
250612|NCT01033747|E2|Reported Event|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
250613|NCT01033747|E1|Reported Event|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
250614|NCT01033734|B1|Baseline|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250615|NCT01033734|P1|Participant Flow|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250616|NCT01033734|O4|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250617|NCT01033734|O3|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250618|NCT01033734|O2|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250619|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250620|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250621|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250622|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250623|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250624|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250625|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250626|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
251554|NCT01029886|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
250627|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250628|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250629|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250630|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250631|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250632|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250633|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250634|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250635|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250636|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250701|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250702|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250637|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250638|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250639|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250640|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250641|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250642|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250643|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250644|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250645|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250646|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250703|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250704|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250647|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250648|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250649|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250650|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250651|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250652|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250653|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250654|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250655|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250656|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250705|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250706|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250657|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250658|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250659|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250660|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250661|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250662|NCT01033734|E4|Reported Event|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250663|NCT01033734|E3|Reported Event|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250664|NCT01033734|E2|Reported Event|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250665|NCT01033734|E1|Reported Event|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
250666|NCT01033565|B1|Baseline|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
250667|NCT01033565|P1|Participant Flow|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
250668|NCT01033565|O1|Outcome|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
250669|NCT01033565|E1|Reported Event|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
250707|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
251662|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
250670|NCT01033487|B1|Baseline|Entire Study Population|Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
250671|NCT01033487|P10|Participant Flow|PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
250672|NCT01033487|P9|Participant Flow|PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
250673|NCT01033487|P8|Participant Flow|PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
250674|NCT01033487|P7|Participant Flow|Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
250675|NCT01033487|P6|Participant Flow|PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
250676|NCT01033487|P5|Participant Flow|Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
250708|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250709|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250710|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250711|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250712|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250677|NCT01033487|P4|Participant Flow|PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
250678|NCT01033487|P3|Participant Flow|PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
250679|NCT01033487|P2|Participant Flow|PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
250680|NCT01033487|P1|Participant Flow|PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450|Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
250681|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250682|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250683|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250684|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250685|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250686|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250687|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250688|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250689|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250690|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250691|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250692|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250693|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250694|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250695|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250696|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250697|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250698|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250699|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250700|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
254866|NCT01019928|O1|Outcome|AZD1386 95 mg|
250713|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250714|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250715|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250716|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250717|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250718|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250719|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250720|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250721|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250722|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250723|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250724|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250725|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250726|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250727|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250728|NCT01033487|E5|Reported Event|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
250729|NCT01033487|E4|Reported Event|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
250730|NCT01033487|E3|Reported Event|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
250731|NCT01033487|E2|Reported Event|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
250732|NCT01033487|E1|Reported Event|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
250733|NCT01033383|B5|Baseline|Total|Total of all reporting groups
250734|NCT01033383|B4|Baseline|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
250735|NCT01033383|B3|Baseline|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250736|NCT01033383|B2|Baseline|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250737|NCT01033383|B1|Baseline|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250738|NCT01033383|P4|Participant Flow|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
250739|NCT01033383|P3|Participant Flow|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250740|NCT01033383|P2|Participant Flow|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250741|NCT01033383|P1|Participant Flow|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250742|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
250743|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250744|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250745|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250746|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
250747|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250748|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250749|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250750|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
250751|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250752|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250753|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250754|NCT01033383|E4|Reported Event|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
254867|NCT01019928|O2|Outcome|Placebo|
250755|NCT01033383|E3|Reported Event|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
250756|NCT01033383|E2|Reported Event|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
250757|NCT01033383|E1|Reported Event|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
250758|NCT01033227|B3|Baseline|Total|Total of all reporting groups
250759|NCT01033227|B2|Baseline|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
250760|NCT01033227|B1|Baseline|No Drug|
250761|NCT01033227|P2|Participant Flow|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
250762|NCT01033227|P1|Participant Flow|No Drug|This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
250763|NCT01033227|O2|Outcome|Sodium Nitrite Injection, USP|Administration of sodium nitrite injection, USP
250764|NCT01033227|O1|Outcome|No Drug|Will not receive study drug, there is no placebo in this study. The patient will know they are not receiving the study drug.
250765|NCT01033227|E2|Reported Event|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
250766|NCT01033227|E1|Reported Event|No Drug|This group received no study drug and no placebo. They received standard of care treatment.
250767|NCT01033071|B4|Baseline|Total|Total of all reporting groups
250768|NCT01033071|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250769|NCT01033071|B2|Baseline|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250770|NCT01033071|B1|Baseline|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250771|NCT01033071|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250772|NCT01033071|P2|Participant Flow|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250773|NCT01033071|P1|Participant Flow|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250774|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250853|NCT01032993|B1|Baseline|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250905|NCT01032915|E2|Reported Event|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
254868|NCT01019928|O1|Outcome|AZD1386 95 mg|
250775|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250776|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250777|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250778|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250779|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250780|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250781|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250782|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250783|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250784|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250785|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250786|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250901|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
251009|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
250787|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250788|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250789|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250790|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250791|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250792|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250793|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250794|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250795|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250796|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250797|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250798|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250902|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
251010|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
250799|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250800|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250801|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250802|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250803|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250804|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250805|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250806|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250807|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250808|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250809|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250810|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250903|NCT01032915|E4|Reported Event|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
251011|NCT01032759|E2|Reported Event|Placebo|"Placebo~Placebo: BID"
250811|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250812|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250813|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250814|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250815|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250816|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250817|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250818|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250819|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250820|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250821|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250822|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250904|NCT01032915|E3|Reported Event|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
254869|NCT01019928|O2|Outcome|Placebo|
250823|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250824|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250825|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250826|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250827|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250828|NCT01033071|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
250829|NCT01033071|E2|Reported Event|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250830|NCT01033071|E1|Reported Event|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
250831|NCT01033032|B1|Baseline|All Patients|Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)
250832|NCT01033032|P4|Participant Flow|Dose Level 4|Amrubicin - 120 mg/m^2 every 21 days
250833|NCT01033032|P3|Participant Flow|Dose Level 3|Amrubicin - 110 mg/m^2 IV every 21 days
250834|NCT01033032|P2|Participant Flow|Dose Level 2|Amrubicin - 100 mg/m^2 IV every 21 days
250835|NCT01033032|P1|Participant Flow|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
250836|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
250837|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
250838|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
250839|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
250840|NCT01033032|E1|Reported Event|Dose Level 3|Includes patients treated at the MTD (Dose Level 3)
250841|NCT01033019|B3|Baseline|Total|Total of all reporting groups
250842|NCT01033019|B2|Baseline|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
250843|NCT01033019|B1|Baseline|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
250844|NCT01033019|P2|Participant Flow|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
250845|NCT01033019|P1|Participant Flow|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
250846|NCT01033019|O2|Outcome|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
250847|NCT01033019|O1|Outcome|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
250848|NCT01033019|E3|Reported Event|LDE225 0.75% - nBCC|
250849|NCT01033019|E2|Reported Event|Vehicle - sBCC|Participants topically applied matching placebo cream twice daily for 6 weeks.
250850|NCT01033019|E1|Reported Event|LDE225 0.75% - sBCC|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
250851|NCT01032993|B3|Baseline|Total|Total of all reporting groups
250852|NCT01032993|B2|Baseline|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250854|NCT01032993|P2|Participant Flow|Placebo|The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
250855|NCT01032993|P1|Participant Flow|Coenzyme Q10|The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
250856|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250857|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250858|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250859|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250860|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250861|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250862|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250863|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250864|NCT01032993|E2|Reported Event|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
250865|NCT01032993|E1|Reported Event|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
250866|NCT01032928|B1|Baseline|Respiratory-Swallow Phase Training|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
250867|NCT01032928|P1|Participant Flow|Respiratory - Swallow Phase Training|Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
250868|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were reassessed at one month post treatment
250869|NCT01032928|O2|Outcome|One Week Post-intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
250870|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
250871|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
250872|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
250873|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
250874|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
250875|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
250876|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
250877|NCT01032928|E1|Reported Event|Arm 1|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
250878|NCT01032915|B5|Baseline|Total|Total of all reporting groups
250879|NCT01032915|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250880|NCT01032915|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250881|NCT01032915|B2|Baseline|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
250882|NCT01032915|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250883|NCT01032915|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250884|NCT01032915|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250885|NCT01032915|P2|Participant Flow|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
250886|NCT01032915|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250887|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250888|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250889|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
250890|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250891|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250892|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250893|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
250894|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250895|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250896|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250897|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
250898|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250899|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
250900|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
250906|NCT01032915|E1|Reported Event|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
250907|NCT01032889|B4|Baseline|Total|Total of all reporting groups
250908|NCT01032889|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250909|NCT01032889|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250910|NCT01032889|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250911|NCT01032889|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250912|NCT01032889|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250913|NCT01032889|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250914|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250915|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250916|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250917|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250918|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250919|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250920|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250921|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250922|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250923|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250924|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250925|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250926|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250927|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250928|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250929|NCT01032889|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250930|NCT01032889|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250931|NCT01032889|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
250932|NCT01032850|B1|Baseline|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250933|NCT01032850|P1|Participant Flow|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
251012|NCT01032759|E1|Reported Event|Memantine|Memantine: 20 mg, BID
251013|NCT01032733|B3|Baseline|Total|Total of all reporting groups
250934|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250935|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250936|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250937|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250938|NCT01032850|E1|Reported Event|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
250939|NCT01032837|B5|Baseline|Total|Total of all reporting groups
250940|NCT01032837|B4|Baseline|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250941|NCT01032837|B3|Baseline|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250942|NCT01032837|B2|Baseline|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250943|NCT01032837|B1|Baseline|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250944|NCT01032837|P4|Participant Flow|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250945|NCT01032837|P3|Participant Flow|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250946|NCT01032837|P2|Participant Flow|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250947|NCT01032837|P1|Participant Flow|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250948|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250949|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250950|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250951|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250952|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250953|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
254870|NCT01019928|O1|Outcome|AZD1386 95 mg|
250954|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250955|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250956|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250957|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250958|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250959|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250960|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250961|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250962|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250963|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250964|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250965|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250966|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250967|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250968|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250969|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250970|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250971|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250972|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250973|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250974|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
254871|NCT01019928|O2|Outcome|Placebo|
250975|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250976|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250977|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250978|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250979|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250980|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250981|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250982|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250983|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250984|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250985|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250986|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250987|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250988|NCT01032837|E4|Reported Event|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
250989|NCT01032837|E3|Reported Event|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250990|NCT01032837|E2|Reported Event|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
250991|NCT01032837|E1|Reported Event|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
250992|NCT01032759|B3|Baseline|Total|Total of all reporting groups
250993|NCT01032759|B2|Baseline|Placebo|"Placebo~Placebo: BID"
250994|NCT01032759|B1|Baseline|Memantine|Memantine: 20 mg, BID
250995|NCT01032759|P2|Participant Flow|Placebo|"Placebo~Placebo: BID"
250996|NCT01032759|P1|Participant Flow|Memantine|Memantine: 20 mg, BID
250997|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
250998|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
250999|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
251000|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
251001|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
251002|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
251003|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
251004|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
251005|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
251006|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
251007|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
251008|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
251014|NCT01032733|B2|Baseline|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251015|NCT01032733|B1|Baseline|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251016|NCT01032733|P2|Participant Flow|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251017|NCT01032733|P1|Participant Flow|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251018|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251019|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251020|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251021|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251022|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251023|NCT01032733|O1|Outcome|Lifestyle Counseling|
251024|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251025|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251026|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251027|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251028|NCT01032733|E2|Reported Event|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
251029|NCT01032733|E1|Reported Event|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
251030|NCT01032694|B3|Baseline|Total|Total of all reporting groups
251031|NCT01032694|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251032|NCT01032694|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251033|NCT01032694|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251034|NCT01032694|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251035|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251036|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251037|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251038|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251039|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251040|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251041|NCT01032694|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251042|NCT01032694|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251043|NCT01032538|B1|Baseline|Patients With Knee Osteoarthritis|Patients eglible for medial unicompartmental knee replacement
251044|NCT01032538|P1|Participant Flow|Patients With Knee Osteoarthritis|Patients eglible for unicondylar knee replacement
251045|NCT01032538|O1|Outcome|Passive ROM 2 Years|Range of motion measured by physiotherapist
251046|NCT01032538|O2|Outcome|KOOS ADL 2 Years|Activities of dayly living score
251047|NCT01032538|O1|Outcome|KOOS Pain 2 Years|Knee pain score, one of 5 subscores of KOOS
251048|NCT01032538|E1|Reported Event|Patients With Knee Osteoarthritis|Patients eglible for unicompartmental knee replacement
251049|NCT01032382|B3|Baseline|Total|Total of all reporting groups
251050|NCT01032382|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251051|NCT01032382|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251052|NCT01032382|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251053|NCT01032382|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251054|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251055|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251056|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251057|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251058|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
254872|NCT01019928|O1|Outcome|AZD1386 95 mg|
251059|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251060|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251061|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251062|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251063|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251064|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251065|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251066|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251067|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251068|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251069|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251070|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251071|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251072|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251073|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251074|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251075|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251076|NCT01032382|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
251077|NCT01032382|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
251078|NCT01032291|B4|Baseline|Total|Total of all reporting groups
251079|NCT01032291|B3|Baseline|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251080|NCT01032291|B2|Baseline|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251081|NCT01032291|B1|Baseline|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251082|NCT01032291|P3|Participant Flow|Lenalidomide + Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251083|NCT01032291|P2|Participant Flow|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251084|NCT01032291|P1|Participant Flow|Lenalidomide + Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251085|NCT01032291|O2|Outcome|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251086|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251087|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251088|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251089|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251090|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251091|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251126|NCT01032265|E2|Reported Event|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251092|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251093|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251094|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251095|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251096|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251097|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251098|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251099|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251100|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251101|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251102|NCT01032291|O2|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251103|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251104|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251105|NCT01032291|E2|Reported Event|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
251106|NCT01032291|E1|Reported Event|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
251107|NCT01032265|B3|Baseline|Total|Total of all reporting groups
251108|NCT01032265|B2|Baseline|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251109|NCT01032265|B1|Baseline|Postal Treatment|Information (including life style), and PFMT exercises.
251110|NCT01032265|P2|Participant Flow|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251111|NCT01032265|P1|Participant Flow|Postal Treatment|Information (including life style), and PFMT exercises.
251112|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251113|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251114|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251115|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251116|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251117|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251118|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251119|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251120|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251121|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251122|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251123|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251124|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
251125|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
251127|NCT01032265|E1|Reported Event|Postal Treatment|Information (including life style), and PFMT exercises.
251128|NCT01032200|B3|Baseline|Total|Total of all reporting groups
251129|NCT01032200|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251130|NCT01032200|B1|Baseline|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251131|NCT01032200|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251132|NCT01032200|P1|Participant Flow|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251133|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251134|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251135|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251136|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251137|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251138|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251139|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251140|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251141|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251142|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251143|NCT01032200|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
251144|NCT01032200|E1|Reported Event|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
251145|NCT01032174|B3|Baseline|Total|Total of all reporting groups
251146|NCT01032174|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251147|NCT01032174|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251148|NCT01032174|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251149|NCT01032174|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251150|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251151|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251152|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251153|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251154|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251155|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251156|NCT01032174|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
251157|NCT01032174|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
251158|NCT01032070|B3|Baseline|Total|Total of all reporting groups
251159|NCT01032070|B2|Baseline|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251160|NCT01032070|B1|Baseline|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251161|NCT01032070|P2|Participant Flow|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251162|NCT01032070|P1|Participant Flow|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251163|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251164|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251165|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251166|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251167|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251168|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251169|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251170|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251171|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251172|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251173|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251174|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251175|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251176|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251177|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251178|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251179|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251180|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251181|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251182|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251183|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251184|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251185|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251186|NCT01032070|E2|Reported Event|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251187|NCT01032070|E1|Reported Event|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
251188|NCT01032044|B3|Baseline|Total|Total of all reporting groups
251189|NCT01032044|B2|Baseline|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
251190|NCT01032044|B1|Baseline|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
251384|NCT01030965|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251191|NCT01032044|P2|Participant Flow|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
251192|NCT01032044|P1|Participant Flow|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
251193|NCT01032044|O2|Outcome|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
251194|NCT01032044|O1|Outcome|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
251195|NCT01032044|E2|Reported Event|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
251196|NCT01032044|E1|Reported Event|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
251197|NCT01032018|B3|Baseline|Total|Total of all reporting groups
251198|NCT01032018|B2|Baseline|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
251199|NCT01032018|B1|Baseline|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
251200|NCT01032018|P2|Participant Flow|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
251201|NCT01032018|P1|Participant Flow|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
251202|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
251203|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
251204|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
251205|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
251206|NCT01032018|E2|Reported Event|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
251207|NCT01032018|E1|Reported Event|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
251208|NCT01031953|B1|Baseline|Fosaprepitant|
251209|NCT01031953|P1|Participant Flow|Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
251210|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome
251211|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|participants with self report fatigue or sedation after receiving fosaprepitant
251212|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant
251213|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant
251214|NCT01031953|O1|Outcome|Participants Who Recieved Fosaprepitant|Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant
251215|NCT01031953|O1|Outcome|Change in Nausea Score From 2 Hours to 12 and 24 Hours|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
251216|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
251217|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
251218|NCT01031953|E1|Reported Event|Fosaprepitant|
251219|NCT01031914|B1|Baseline|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
251220|NCT01031914|P1|Participant Flow|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have obstructive sleep apnea (OSA) and will be current CPAP users.
251221|NCT01031914|O1|Outcome|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
251222|NCT01031914|E1|Reported Event|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
251223|NCT01031810|B1|Baseline|Tranylcypromine|patients will receive treatment with tranylcypromine
251224|NCT01031810|P1|Participant Flow|Tranylcypromine|Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.
251225|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
251226|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
251227|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
251228|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
251229|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg"
251230|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
251231|NCT01031810|E1|Reported Event|Tranylcypromine|patients will receive treatment with tranylcypromine
251232|NCT01031706|B3|Baseline|Total|Total of all reporting groups
251233|NCT01031706|B2|Baseline|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
251234|NCT01031706|B1|Baseline|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
251235|NCT01031706|P2|Participant Flow|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
251236|NCT01031706|P1|Participant Flow|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
251237|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
251238|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
251239|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
251240|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
251241|NCT01031706|E2|Reported Event|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
251242|NCT01031706|E1|Reported Event|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
251243|NCT01031680|B3|Baseline|Total|Total of all reporting groups
251244|NCT01031680|B2|Baseline|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251245|NCT01031680|B1|Baseline|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251246|NCT01031680|P2|Participant Flow|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251247|NCT01031680|P1|Participant Flow|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251248|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251249|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251250|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251251|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251252|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251253|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251254|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251255|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251256|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251257|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251258|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251259|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251260|NCT01031680|E2|Reported Event|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
251261|NCT01031680|E1|Reported Event|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
251262|NCT01031628|B5|Baseline|Total|Total of all reporting groups
251263|NCT01031628|B4|Baseline|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251264|NCT01031628|B3|Baseline|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251265|NCT01031628|B2|Baseline|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251266|NCT01031628|B1|Baseline|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251663|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251267|NCT01031628|P4|Participant Flow|400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251268|NCT01031628|P3|Participant Flow|400 mg for Patients With Imatinib Blood Levels ≥ 1100|"Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251269|NCT01031628|P2|Participant Flow|600 or 800 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251270|NCT01031628|P1|Participant Flow|400 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251271|NCT01031628|O4|Outcome|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251272|NCT01031628|O3|Outcome|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251273|NCT01031628|O2|Outcome|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251274|NCT01031628|O1|Outcome|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251275|NCT01031628|E4|Reported Event|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251276|NCT01031628|E3|Reported Event|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251277|NCT01031628|E2|Reported Event|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251278|NCT01031628|E1|Reported Event|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
251279|NCT01031550|B3|Baseline|Total|Total of all reporting groups
251280|NCT01031550|B2|Baseline|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
251281|NCT01031550|B1|Baseline|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
251282|NCT01031550|P2|Participant Flow|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
251283|NCT01031550|P1|Participant Flow|Standard Anesthetic Management|standard anesthetic management propofol 100-150mcg/kg/min
251284|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
251285|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
251286|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
251287|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
251288|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
251289|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
251290|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
251291|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
251292|NCT01031550|E2|Reported Event|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
251293|NCT01031550|E1|Reported Event|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
251294|NCT01031498|B4|Baseline|Total|Total of all reporting groups
251295|NCT01031498|B3|Baseline|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
251296|NCT01031498|B2|Baseline|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
251297|NCT01031498|B1|Baseline|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
251298|NCT01031498|P3|Participant Flow|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
251299|NCT01031498|P2|Participant Flow|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
251300|NCT01031498|P1|Participant Flow|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
251301|NCT01031498|O3|Outcome|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
251302|NCT01031498|O2|Outcome|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
251303|NCT01031498|O1|Outcome|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
251304|NCT01031498|E3|Reported Event|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
251305|NCT01031498|E2|Reported Event|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
251306|NCT01031498|E1|Reported Event|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
251307|NCT01031446|B1|Baseline|RAD001 Cisplatin Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
251308|NCT01031446|P1|Participant Flow|RAD001 and Cisplatin and Pacletaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks. All patients began at the same dose level of the study drugs with no de-escalation of dose, thus results for Phase I and II were combined
251309|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
251310|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
251311|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
251312|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
251313|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
251314|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitazel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
251315|NCT01031446|E1|Reported Event|RAD001 and Cisplatin and Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
251316|NCT01031381|B1|Baseline|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
251317|NCT01031381|P1|Participant Flow|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
251318|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
251319|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
251320|NCT01031381|E1|Reported Event|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
251321|NCT01031095|B3|Baseline|Total|Total of all reporting groups
251322|NCT01031095|B2|Baseline|Standard Therapy|standard UFH treatment
251323|NCT01031095|B1|Baseline|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
251324|NCT01031095|P2|Participant Flow|Standard Therapy|standard unfractionated heparin (UFH) treatment
251325|NCT01031095|P1|Participant Flow|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
251326|NCT01031095|O1|Outcome|Low Dose Intracoronary Heparin Treatment Arm|low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)
251327|NCT01031095|O1|Outcome|Standard Therapy|standard UFH treatment (intravenous standard dose unfractioned heparin group)
251328|NCT01031095|E2|Reported Event|Standard Therapy|standard UFH treatment
251329|NCT01031095|E1|Reported Event|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
251330|NCT01031043|B1|Baseline|Topical Bethanechol|patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
251385|NCT01030965|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251386|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251387|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251331|NCT01031043|P1|Participant Flow|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
251332|NCT01031043|O1|Outcome|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
251333|NCT01031043|E1|Reported Event|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
251334|NCT01031004|B3|Baseline|Total|Total of all reporting groups
251335|NCT01031004|B2|Baseline|Etafilcon A|contact lens worn as single use, daily wear
251336|NCT01031004|B1|Baseline|Narafilcon B|single use, daily wear contact lens
251337|NCT01031004|P2|Participant Flow|Etafilcon A|contact lens worn as single use, daily wear
251338|NCT01031004|P1|Participant Flow|Narafilcon B|single use, daily wear contact lens
251339|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251340|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251341|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251342|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251343|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251344|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251345|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251346|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251347|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251348|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251349|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251350|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251351|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251352|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251353|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251354|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251355|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251356|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251357|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251358|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251359|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251360|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251361|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251362|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251363|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251364|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251365|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251366|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251367|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251368|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251369|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251370|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251371|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251372|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251373|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
251374|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
251375|NCT01031004|E2|Reported Event|Etafilcon A|contact lens worn as single use, daily wear
251376|NCT01031004|E1|Reported Event|Narafilcon B|single use, daily wear contact lens
251377|NCT01030965|B5|Baseline|Total|Total of all reporting groups
251378|NCT01030965|B4|Baseline|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251379|NCT01030965|B3|Baseline|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251380|NCT01030965|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251381|NCT01030965|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251382|NCT01030965|P4|Participant Flow|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251383|NCT01030965|P3|Participant Flow|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251664|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251388|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251389|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251390|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251391|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251392|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251393|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251394|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251395|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251396|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251397|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251398|NCT01030965|E4|Reported Event|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
251399|NCT01030965|E3|Reported Event|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
251400|NCT01030965|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
251401|NCT01030965|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
251402|NCT01030952|B3|Baseline|Total|Total of all reporting groups
251403|NCT01030952|B2|Baseline|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
251404|NCT01030952|B1|Baseline|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
251405|NCT01030952|P2|Participant Flow|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
251406|NCT01030952|P1|Participant Flow|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
251407|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251408|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251409|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251410|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251411|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251412|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251413|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251414|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251415|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251416|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251417|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251418|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251419|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251420|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251421|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251422|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251423|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
251424|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
251425|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
251426|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
251427|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251428|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251429|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251430|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251431|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251432|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251433|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251434|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251435|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251436|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251437|NCT01030952|E2|Reported Event|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
251438|NCT01030952|E1|Reported Event|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
251551|NCT01029886|B2|Baseline|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251439|NCT01030757|B1|Baseline|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
251440|NCT01030757|P1|Participant Flow|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
251441|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
251442|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
251443|NCT01030757|E1|Reported Event|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
251444|NCT01030718|B4|Baseline|Total|Total of all reporting groups
251445|NCT01030718|B3|Baseline|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251446|NCT01030718|B2|Baseline|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251447|NCT01030718|B1|Baseline|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251448|NCT01030718|P3|Participant Flow|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251449|NCT01030718|P2|Participant Flow|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251450|NCT01030718|P1|Participant Flow|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251451|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251552|NCT01029886|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251553|NCT01029886|P2|Participant Flow|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251452|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251453|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251454|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251455|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251456|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251457|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251458|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251459|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251460|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251461|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251462|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251463|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251464|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251465|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251482|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251466|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251467|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251468|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251469|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251470|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251471|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251472|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251473|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251474|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251475|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251476|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251477|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251478|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251479|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251480|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251481|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251483|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251484|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251485|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251486|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251487|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251488|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251489|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251490|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251491|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251492|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251493|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251494|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251495|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251496|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251497|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251548|NCT01029925|O1|Outcome|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
251498|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251499|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251500|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251501|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251502|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251503|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251504|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251505|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251506|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251507|NCT01030718|E1|Reported Event|All Treated Participants|Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
251508|NCT01030666|B3|Baseline|Total|Total of all reporting groups
251509|NCT01030666|B2|Baseline|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
251510|NCT01030666|B1|Baseline|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
251511|NCT01030666|P2|Participant Flow|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
251512|NCT01030666|P1|Participant Flow|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
251513|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251514|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251515|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251516|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251517|NCT01030666|E2|Reported Event|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251549|NCT01029925|E1|Reported Event|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
251518|NCT01030666|E1|Reported Event|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
251519|NCT01030653|B3|Baseline|Total|Total of all reporting groups
251520|NCT01030653|B2|Baseline|Voriconazole Low Dose First Then High Dose|
251521|NCT01030653|B1|Baseline|Voriconazole High Dose First Then Low Dose|Both voriconazole arms are shown as a single group because the same individuals received both arms of the intervention in a cross-over design.
251522|NCT01030653|P2|Participant Flow|Voriconazole Low Dose First Then High Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses)
251523|NCT01030653|P1|Participant Flow|Voriconazole High Dose First Then Low Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses)
251524|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
251525|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
251526|NCT01030653|O1|Outcome|Voriconazole High : Low Dose|"Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)~Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)"
251527|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
251528|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
251529|NCT01030653|E2|Reported Event|Voriconazole Low Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
251530|NCT01030653|E1|Reported Event|Voriconazole High Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
251531|NCT01030458|B3|Baseline|Total|Total of all reporting groups
251532|NCT01030458|B2|Baseline|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251533|NCT01030458|B1|Baseline|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251534|NCT01030458|P2|Participant Flow|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
251535|NCT01030458|P1|Participant Flow|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
251536|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251537|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251538|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251539|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251540|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251541|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251542|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251543|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251544|NCT01030458|E2|Reported Event|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
251545|NCT01030458|E1|Reported Event|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
251546|NCT01029925|B1|Baseline|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
251547|NCT01029925|P1|Participant Flow|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
251555|NCT01029886|O4|Outcome|Liraglutide Once Daily Without SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening
251556|NCT01029886|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection, 2mg, once weekly and without SU use at screening
251557|NCT01029886|O2|Outcome|Liraglutide Once Daily With SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening
251558|NCT01029886|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection, 2mg, once weekly and with SU use at screening
251559|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251560|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251561|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251562|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251563|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251564|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251565|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251566|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251567|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251568|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251569|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251570|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251571|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251572|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251573|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251574|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251575|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251576|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251577|NCT01029886|E2|Reported Event|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
251578|NCT01029886|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
251579|NCT01029795|B3|Baseline|Total|Total of all reporting groups
251580|NCT01029795|B2|Baseline|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251581|NCT01029795|B1|Baseline|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251582|NCT01029795|P2|Participant Flow|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251583|NCT01029795|P1|Participant Flow|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251584|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251585|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251586|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251587|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251588|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251589|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251590|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251665|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251666|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
251591|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251592|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251593|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251594|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251595|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251596|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251597|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251598|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251599|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251600|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251601|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251602|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251603|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251604|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251605|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251606|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251607|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251608|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251609|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251610|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251667|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251668|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251611|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251612|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251613|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251614|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251615|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251616|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251617|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251618|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251619|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251620|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251621|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251622|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251623|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251624|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251625|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251626|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251627|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251628|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251629|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251630|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251669|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251670|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251631|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251632|NCT01029795|E2|Reported Event|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
251633|NCT01029795|E1|Reported Event|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
251634|NCT01029730|B1|Baseline|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251635|NCT01029730|P1|Participant Flow|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251636|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251637|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251638|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251639|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251640|NCT01029730|E1|Reported Event|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
251641|NCT01029704|B6|Baseline|Total|Total of all reporting groups
251642|NCT01029704|B5|Baseline|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251643|NCT01029704|B4|Baseline|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251644|NCT01029704|B3|Baseline|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251645|NCT01029704|B2|Baseline|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251646|NCT01029704|B1|Baseline|Placebo|Received no drug (EGT0001442) during 28 days
251647|NCT01029704|P5|Participant Flow|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251648|NCT01029704|P4|Participant Flow|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251649|NCT01029704|P3|Participant Flow|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251650|NCT01029704|P2|Participant Flow|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251651|NCT01029704|P1|Participant Flow|Placebo|Received no drug (EGT0001442) during 28 days
251652|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251653|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251654|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251655|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251656|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
251657|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251658|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251659|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251660|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251661|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
251671|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
251672|NCT01029704|E5|Reported Event|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
251673|NCT01029704|E4|Reported Event|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
251674|NCT01029704|E3|Reported Event|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
251675|NCT01029704|E2|Reported Event|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
251676|NCT01029704|E1|Reported Event|Placebo|Received no drug (EGT0001442) during 28 days
251677|NCT01029652|B3|Baseline|Total|Total of all reporting groups
251678|NCT01029652|B2|Baseline|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251679|NCT01029652|B1|Baseline|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251680|NCT01029652|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study ."
251681|NCT01029652|P1|Participant Flow|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study"
251682|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251683|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251684|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251685|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251731|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
252456|NCT01027598|P1|Participant Flow|Erlotinib + Pazopanib|"Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
251686|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251687|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251688|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251689|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251690|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251691|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251692|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251693|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251694|NCT01029652|O6|Outcome|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
251695|NCT01029652|O5|Outcome|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
251800|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251696|NCT01029652|O4|Outcome|Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
251697|NCT01029652|O3|Outcome|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
251698|NCT01029652|O2|Outcome|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
251699|NCT01029652|O1|Outcome|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251700|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251701|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251702|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
251703|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251704|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching."
251705|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251706|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
251707|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251708|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251709|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251710|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251711|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251712|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251713|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251714|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251715|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251716|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251717|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251718|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
252075|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
251719|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251720|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251721|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251722|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251723|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251724|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251725|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251726|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251727|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251728|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251729|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251730|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251778|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251732|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251733|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251734|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251735|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251736|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251737|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251738|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251739|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251740|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251741|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251742|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251743|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251744|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
254873|NCT01019928|E2|Reported Event|Placebo|
251745|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251746|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251747|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251748|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251749|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251750|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251751|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
251752|NCT01029652|E6|Reported Event|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
251753|NCT01029652|E5|Reported Event|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
251754|NCT01029652|E4|Reported Event|All Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
251755|NCT01029652|E3|Reported Event|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
251756|NCT01029652|E2|Reported Event|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
251757|NCT01029652|E1|Reported Event|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
251758|NCT01029535|B1|Baseline|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251759|NCT01029535|P1|Participant Flow|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251760|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251761|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251762|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251763|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251764|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251765|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251766|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251767|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251768|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251769|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251770|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251771|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251772|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251773|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251774|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251775|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251776|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251777|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
252457|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
251779|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251780|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251781|NCT01029535|E2|Reported Event|Juvederm® VOLUMA™_Phase 2|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251782|NCT01029535|E1|Reported Event|Juvederm® VOLUMA™_Phase 1|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
251783|NCT01029340|B6|Baseline|Total|Total of all reporting groups
251784|NCT01029340|B5|Baseline|Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251785|NCT01029340|B4|Baseline|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
251786|NCT01029340|B3|Baseline|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
251787|NCT01029340|B2|Baseline|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
251788|NCT01029340|B1|Baseline|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
251789|NCT01029340|P6|Participant Flow|Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
251790|NCT01029340|P5|Participant Flow|Arm 5: Recombinant Factor VIII by CS/EP|Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251791|NCT01029340|P4|Participant Flow|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months
251792|NCT01029340|P3|Participant Flow|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
251793|NCT01029340|P2|Participant Flow|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
251794|NCT01029340|P1|Participant Flow|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
251795|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251796|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251797|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251798|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251799|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
252076|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
251801|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251802|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
251803|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
251804|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251805|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
251806|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251807|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251808|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
251809|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
251810|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
251811|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
251812|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
251813|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
251814|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
251815|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
251816|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
251817|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
251818|NCT01029340|E4|Reported Event|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks.
251819|NCT01029340|E3|Reported Event|Recombinant Factor VIII (BAY81-8973) Part B and Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
251820|NCT01029340|E2|Reported Event|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
251821|NCT01029340|E1|Reported Event|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
251822|NCT01029262|B3|Baseline|Total|Total of all reporting groups
251823|NCT01029262|B2|Baseline|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251824|NCT01029262|B1|Baseline|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251825|NCT01029262|P2|Participant Flow|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251826|NCT01029262|P1|Participant Flow|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
252458|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
251827|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251828|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251829|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251830|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251831|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251832|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251833|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251834|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251835|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251836|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251837|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251838|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251839|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251840|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251841|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251842|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251843|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251844|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251845|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251846|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251847|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251848|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251849|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251850|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251851|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251852|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251853|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251854|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.
251855|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251856|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251857|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251858|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251859|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251860|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251861|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min."
251862|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.
251863|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251864|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251865|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251866|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251867|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251868|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251869|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251870|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251871|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251872|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251873|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251874|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251875|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251876|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251877|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
251878|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
251879|NCT01029262|E2|Reported Event|Lenalidomide|Lenalidomide 10 mg daily (QD) by mouth (PO) + 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Or 5 mg Lenalidomide capsule + 2 placebo capsules PO QD for participants with a creatinine clearance between 40 and 60 mL/min.
251880|NCT01029262|E1|Reported Event|Placebo|3 placebo capsules PO QD for at least 168 days unless disease progression or intolerable side effects.
251881|NCT01029054|B1|Baseline|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251882|NCT01029054|P3|Participant Flow|Dose Escalation Cohort 3|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251883|NCT01029054|P2|Participant Flow|Dose Escalation Cohort 2|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251884|NCT01029054|P1|Participant Flow|Dose Escalation Cohort 1|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251885|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251886|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251887|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251888|NCT01029054|E1|Reported Event|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
251889|NCT01028911|B3|Baseline|Total|Total of all reporting groups
251890|NCT01028911|B2|Baseline|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251891|NCT01028911|B1|Baseline|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251892|NCT01028911|P2|Participant Flow|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251893|NCT01028911|P1|Participant Flow|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251894|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251895|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251896|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
252077|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
251897|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251898|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251899|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251900|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251901|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251902|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251903|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251904|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251905|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251906|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251907|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251908|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251909|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251910|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251911|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251912|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251913|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
252777|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
251914|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251915|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251916|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251917|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251918|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251919|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251920|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251921|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251922|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251923|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251924|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251925|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251926|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251927|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251928|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251929|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251930|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251931|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
252459|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
254874|NCT01019928|E1|Reported Event|AZD1386 95 mg|
251932|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251933|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251934|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251935|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251936|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251937|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251938|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251939|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251940|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251941|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251942|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251943|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251944|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251945|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251946|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251947|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251948|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251949|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
252460|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
256500|NCT01015703|O1|Outcome|1 mg Dose|1 mg CoVaccine HT
251950|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251951|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251952|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251953|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251954|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251955|NCT01028911|E2|Reported Event|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251956|NCT01028911|E1|Reported Event|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
251957|NCT01028820|B1|Baseline|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251958|NCT01028820|P1|Participant Flow|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251959|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251960|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251961|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251962|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251963|NCT01028820|E1|Reported Event|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
251964|NCT01027364|B5|Baseline|Total|Total of all reporting groups
251965|NCT01027364|B4|Baseline|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
251966|NCT01027364|B3|Baseline|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
251967|NCT01027364|B2|Baseline|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252006|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252078|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
256501|NCT01015703|E5|Reported Event|10 mg Dose|10 mg CoVaccine HT
251968|NCT01027364|B1|Baseline|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
251969|NCT01027364|P4|Participant Flow|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
251970|NCT01027364|P3|Participant Flow|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
251971|NCT01027364|P2|Participant Flow|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
251972|NCT01027364|P1|Participant Flow|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
251973|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
251974|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
251975|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
251976|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
251977|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
251978|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
251979|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
252113|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
251980|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251981|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251982|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251983|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251984|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251985|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251986|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
252024|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252025|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
256502|NCT01015703|E4|Reported Event|7 mg Dose|7 mg CoVaccine HT
251987|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251988|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251989|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251990|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251991|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
251992|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
251993|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
251994|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251995|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251996|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251997|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251998|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
251999|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
252000|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
252001|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
252002|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252003|NCT01027364|O5|Outcome|Total|All participants from Arms 1-4
252004|NCT01027364|O4|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252005|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252070|NCT01027351|P3|Participant Flow|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252778|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252007|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252008|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252009|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252010|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252011|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252012|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
252013|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
252014|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
252015|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
252016|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
252017|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
252018|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252019|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252020|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252021|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252022|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252023|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252461|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
256503|NCT01015703|E3|Reported Event|5 mg Dose|5 mg CoVaccine HT
252026|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252027|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252028|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252029|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252030|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252031|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252032|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252033|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252034|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252035|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252036|NCT01027364|O1|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252037|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252038|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252039|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252040|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252041|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252042|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252043|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252044|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252045|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252046|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252047|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252048|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252049|NCT01027364|O5|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
252050|NCT01027364|O4|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252051|NCT01027364|O3|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252071|NCT01027351|P2|Participant Flow|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252072|NCT01027351|P1|Participant Flow|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252073|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252462|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
252052|NCT01027364|O2|Outcome|Arm 1: Weekly Prophylaxis-rFIXFc|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252053|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis-BeneFIX|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252054|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252055|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252056|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252057|NCT01027364|E3|Reported Event|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
252058|NCT01027364|E2|Reported Event|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
252059|NCT01027364|E1|Reported Event|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
252060|NCT01027351|B7|Baseline|Total|Total of all reporting groups
252061|NCT01027351|B6|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252062|NCT01027351|B5|Baseline|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252063|NCT01027351|B4|Baseline|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252064|NCT01027351|B3|Baseline|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252065|NCT01027351|B2|Baseline|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252066|NCT01027351|B1|Baseline|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252067|NCT01027351|P6|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252068|NCT01027351|P5|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252069|NCT01027351|P4|Participant Flow|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252074|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252079|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252080|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252081|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252082|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252083|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252084|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252085|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252086|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252087|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252088|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252089|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252090|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252091|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252092|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252093|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252094|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252095|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252096|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252097|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252098|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252099|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252100|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252101|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252102|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252103|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252104|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252105|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252106|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252107|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252108|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252109|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252110|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252111|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252112|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252114|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252115|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252116|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252117|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252118|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252119|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252120|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252121|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252122|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252123|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252124|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252125|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252126|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252127|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252128|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252129|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252130|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252131|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252132|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252133|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252134|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252135|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252136|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252137|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252138|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252139|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252140|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252141|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252142|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252143|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252144|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252145|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252146|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252147|NCT01027351|E6|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
252148|NCT01027351|E5|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252149|NCT01027351|E4|Reported Event|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
252150|NCT01027351|E3|Reported Event|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
252151|NCT01027351|E2|Reported Event|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
252152|NCT01027351|E1|Reported Event|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
252153|NCT01027286|B3|Baseline|Total|Total of all reporting groups
252154|NCT01027286|B2|Baseline|Control|No Vitagel used during primary total knee arthroplasty
252155|NCT01027286|B1|Baseline|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252156|NCT01027286|P2|Participant Flow|Control|No Vitagel used during primary total knee arthroplasty
252157|NCT01027286|P1|Participant Flow|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252158|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252159|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252160|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252161|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252162|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252163|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252164|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252165|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252166|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252167|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252168|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252169|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252170|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
252171|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252172|NCT01027286|E2|Reported Event|Control|No Vitagel used during primary total knee arthroplasty
252173|NCT01027286|E1|Reported Event|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
252174|NCT01027273|B3|Baseline|Total|Total of all reporting groups
252175|NCT01027273|B2|Baseline|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252176|NCT01027273|B1|Baseline|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252177|NCT01027273|P2|Participant Flow|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252225|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
256504|NCT01015703|E2|Reported Event|2 mg Dose|2 mg CoVaccine HT
252178|NCT01027273|P1|Participant Flow|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252179|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252180|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252181|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252182|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252183|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252184|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252185|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252186|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252187|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252226|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252463|NCT01027598|E2|Reported Event|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
252188|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252189|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252190|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252191|NCT01027273|E2|Reported Event|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
252192|NCT01027273|E1|Reported Event|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
252193|NCT01028391|B3|Baseline|Total|Total of all reporting groups
252194|NCT01028391|B2|Baseline|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
252195|NCT01028391|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
252196|NCT01028391|P2|Participant Flow|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
252197|NCT01028391|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
252198|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
252199|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
252200|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
252454|NCT01027598|B1|Baseline|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
252201|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
252202|NCT01028391|E2|Reported Event|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
252203|NCT01028391|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
252204|NCT01028378|B1|Baseline|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252205|NCT01028378|P1|Participant Flow|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252206|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252207|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252208|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252209|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252210|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252211|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252212|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252213|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252214|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252215|NCT01028378|E1|Reported Event|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
252216|NCT01028352|B1|Baseline|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
252217|NCT01028352|P1|Participant Flow|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
252218|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
252219|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
252220|NCT01028352|E1|Reported Event|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
252221|NCT01028300|B1|Baseline|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252222|NCT01028300|P1|Participant Flow|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252223|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252224|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252227|NCT01028300|E1|Reported Event|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
252228|NCT01028222|B3|Baseline|Total|Total of all reporting groups
252229|NCT01028222|B2|Baseline|DTIC|850 mg/m2 IV every 3 weeks
252230|NCT01028222|B1|Baseline|Nilotinib|400 mg twice daily
252231|NCT01028222|P2|Participant Flow|DTIC|850 mg/m2 IV every 3 weeks
252232|NCT01028222|P1|Participant Flow|Nilotinib|400 mg twice daily
252233|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252234|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252235|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252236|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252237|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252238|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252239|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252240|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252241|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252242|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252243|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252244|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252245|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252246|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252247|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
252248|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
252249|NCT01028222|E3|Reported Event|Crossover Nilotinib Treatment|Crossover nilotinib treatment
252250|NCT01028222|E2|Reported Event|DTIC|850 mg/m2 IV every 3 weeks
252251|NCT01028222|E1|Reported Event|Nilotinib|400 mg twice daily
252252|NCT01028131|B5|Baseline|Total|Total of all reporting groups
252253|NCT01028131|B4|Baseline|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
252254|NCT01028131|B3|Baseline|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
252255|NCT01028131|B2|Baseline|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
252256|NCT01028131|B1|Baseline|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
252257|NCT01028131|P4|Participant Flow|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
252258|NCT01028131|P3|Participant Flow|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
252259|NCT01028131|P2|Participant Flow|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
252260|NCT01028131|P1|Participant Flow|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
252261|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
252262|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
252263|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
252264|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
252265|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
252266|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
252267|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
252268|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
252269|NCT01028131|E4|Reported Event|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
252270|NCT01028131|E3|Reported Event|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
252271|NCT01028131|E2|Reported Event|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
252272|NCT01028131|E1|Reported Event|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
252273|NCT01028053|B1|Baseline|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
252274|NCT01028053|P1|Participant Flow|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
252275|NCT01028053|O2|Outcome|Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer’s Disease (pAD).
252276|NCT01028053|O1|Outcome|Not Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer’s Disease (pAD).
252277|NCT01028053|O1|Outcome|Hazard Ratio|"The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases."
252278|NCT01028053|E1|Reported Event|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
252279|NCT01028027|B3|Baseline|Total|Total of all reporting groups
252280|NCT01028027|B2|Baseline|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252281|NCT01028027|B1|Baseline|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252282|NCT01028027|P2|Participant Flow|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252283|NCT01028027|P1|Participant Flow|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252284|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252285|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252286|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252287|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252288|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252289|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252290|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252291|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252292|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
256505|NCT01015703|E1|Reported Event|1 mg Dose|1 mg CoVaccine HT
252293|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252294|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252295|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252296|NCT01028027|E2|Reported Event|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252297|NCT01028027|E1|Reported Event|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
252298|NCT01028014|B7|Baseline|Total|Total of all reporting groups
252299|NCT01028014|B6|Baseline|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
252300|NCT01028014|B5|Baseline|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
252301|NCT01028014|B4|Baseline|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
252302|NCT01028014|B3|Baseline|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
252303|NCT01028014|B2|Baseline|Solifenacin 5mg Daily|5 mg capsule, 1 daily for 14 days
252304|NCT01028014|B1|Baseline|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 daily for 14 days
252305|NCT01028014|P6|Participant Flow|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
252306|NCT01028014|P5|Participant Flow|Cyclobenzaprine 10mg Daily|10 mg tablet, one daily for 14 days
252307|NCT01028014|P4|Participant Flow|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
252308|NCT01028014|P3|Participant Flow|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
252309|NCT01028014|P2|Participant Flow|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
252310|NCT01028014|P1|Participant Flow|Pseudoephedrine 120mg ER Daily|120 mg extended release tablet one daily for 14 days
252311|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
252312|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
252313|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
252314|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
252315|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
252316|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
252317|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
252318|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
252319|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
252320|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
252321|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
252322|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
252323|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
252324|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
252325|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
252326|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
252327|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
252328|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
252329|NCT01028014|E6|Reported Event|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
252330|NCT01028014|E5|Reported Event|Cyclobenzaprine 10mg Daily|10mg tablet, one daily for 14 days
252331|NCT01028014|E4|Reported Event|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
252332|NCT01028014|E3|Reported Event|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
252333|NCT01028014|E2|Reported Event|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
252334|NCT01028014|E1|Reported Event|Pseudoephedrine 120mg ER Daily|120mg extended release, one daily for 14 days
252335|NCT01027910|B3|Baseline|Total|Total of all reporting groups
252336|NCT01027910|B2|Baseline|PCI-24781 + Doxorubicin With Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.
252337|NCT01027910|B1|Baseline|PCI-24781 + Doxorubicin Without Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.
252338|NCT01027910|P2|Participant Flow|PCI-24781 + Doxorubicin With Mandatory GCSF|"PCI-24781 + Doxorubicin with mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
252779|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252339|NCT01027910|P1|Participant Flow|PCI-24781 + Doxorubicin Without Mandatory GCSF|"PCI-24781 + Doxorubicin without mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
252340|NCT01027910|O2|Outcome|Mandatory GCSF|
252341|NCT01027910|O1|Outcome|Optional GCSF|
252342|NCT01027910|O2|Outcome|Mandatory GCSF|
252343|NCT01027910|O1|Outcome|Optional GCSF|
252344|NCT01027910|O2|Outcome|Mandatory GCSF|
252345|NCT01027910|O1|Outcome|Optional GCSF|
252346|NCT01027910|O2|Outcome|PCI-24781 With Mandatory GCSF|
252347|NCT01027910|O1|Outcome|PCI-24781 + Doxorubicin Without Mandatory GCSF|
252348|NCT01027910|E2|Reported Event|PCI-24781+Dox With Mandated GCSF|Patients in this are were mandated treatment with GCSF
252349|NCT01027910|E1|Reported Event|PCI-24781+Dox Without Mandated GCSF|Patients in this arm were not mandated treatment with GCSF
252350|NCT01027897|B1|Baseline|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252351|NCT01027897|P1|Participant Flow|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252352|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252353|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252354|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252355|NCT01027897|E1|Reported Event|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
252356|NCT01027884|B3|Baseline|Total|Total of all reporting groups
252357|NCT01027884|B2|Baseline|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252358|NCT01027884|B1|Baseline|Placebo|Two matching placebo tablets were taken three times a day with meals
252359|NCT01027884|P2|Participant Flow|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252360|NCT01027884|P1|Participant Flow|Placebo|Two matching placebo tablets were taken three times a day with meals
252361|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252362|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
252363|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252364|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
252365|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252366|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
252367|NCT01027884|O2|Outcome|Idebenone|"Idebenone 900 mg/day~Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
252368|NCT01027884|O1|Outcome|Placebo|"Placebo 900 mg/day~Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
252369|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252370|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
252371|NCT01027884|E2|Reported Event|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
252372|NCT01027884|E1|Reported Event|Placebo|Two matching placebo tablets were taken three times a day with meals
252373|NCT01027819|B3|Baseline|Total|Total of all reporting groups
252374|NCT01027819|B2|Baseline|Fixed Bearing|Mobile bearing vs Fixed bearing
252375|NCT01027819|B1|Baseline|Mobile Bearing|Mobile bearing vs Fixed bearing
252376|NCT01027819|P2|Participant Flow|Fixed Bearing|Mobile bearing vs Fixed bearing
252377|NCT01027819|P1|Participant Flow|Mobile Bearing|Mobile bearing vs Fixed bearing
252378|NCT01027819|O2|Outcome|Fixed Bearing|Mobile bearing vs Fixed bearing
252379|NCT01027819|O1|Outcome|Mobile Bearing|Mobile bearing vs Fixed bearing
252380|NCT01027819|E2|Reported Event|Fixed Bearing|Mobile bearing vs Fixed bearing
252381|NCT01027819|E1|Reported Event|Mobile Bearing|Mobile bearing vs Fixed bearing
252382|NCT01027780|B3|Baseline|Total|Total of all reporting groups
252383|NCT01027780|B2|Baseline|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252384|NCT01027780|B1|Baseline|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252385|NCT01027780|P2|Participant Flow|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252386|NCT01027780|P1|Participant Flow|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252387|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252388|NCT01027780|O1|Outcome|Mindfulness Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252389|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252390|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252391|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252455|NCT01027598|P2|Participant Flow|Erlotinib + Placebo|"Erlotinib: 150 mg orally daily~Placebo: orally daily"
252392|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252393|NCT01027780|E2|Reported Event|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
252394|NCT01027780|E1|Reported Event|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
252395|NCT01027650|B9|Baseline|Total|Total of all reporting groups
252396|NCT01027650|B8|Baseline|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252397|NCT01027650|B7|Baseline|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252398|NCT01027650|B6|Baseline|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252399|NCT01027650|B5|Baseline|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252400|NCT01027650|B4|Baseline|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252401|NCT01027650|B3|Baseline|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252402|NCT01027650|B2|Baseline|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252403|NCT01027650|B1|Baseline|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252404|NCT01027650|P8|Participant Flow|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252405|NCT01027650|P7|Participant Flow|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252406|NCT01027650|P6|Participant Flow|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252407|NCT01027650|P5|Participant Flow|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252408|NCT01027650|P4|Participant Flow|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252409|NCT01027650|P3|Participant Flow|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252410|NCT01027650|P2|Participant Flow|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252411|NCT01027650|P1|Participant Flow|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252412|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252413|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252414|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252415|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252416|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252417|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252418|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252419|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252420|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252421|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252422|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252423|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252424|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252425|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252426|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252427|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252428|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252429|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252430|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252431|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252432|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252433|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252434|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252435|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252436|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252437|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252438|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252439|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252440|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252441|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252442|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252443|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252444|NCT01027650|E8|Reported Event|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
252445|NCT01027650|E7|Reported Event|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
252446|NCT01027650|E6|Reported Event|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
252447|NCT01027650|E5|Reported Event|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
252448|NCT01027650|E4|Reported Event|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
252449|NCT01027650|E3|Reported Event|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
252450|NCT01027650|E2|Reported Event|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
252451|NCT01027650|E1|Reported Event|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
252452|NCT01027598|B3|Baseline|Total|Total of all reporting groups
252453|NCT01027598|B2|Baseline|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
252464|NCT01027598|E1|Reported Event|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
252465|NCT01027468|B1|Baseline|Group 1|3 year follow-up of intravitreal application of bevacizumab
252466|NCT01027468|P1|Participant Flow|Group 1|3 year follow-up of patients with intravitreal application of bevacizumab
252467|NCT01027468|O1|Outcome|Group 1|3 year follow-up of intravitreal application of bevacizumab
252468|NCT01027468|E1|Reported Event|Group 1|3 year follow-up of intravitreal application of bevacizumab
252469|NCT01027195|B3|Baseline|Total|Total of all reporting groups
252470|NCT01027195|B2|Baseline|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252471|NCT01027195|B1|Baseline|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252472|NCT01027195|P2|Participant Flow|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252473|NCT01027195|P1|Participant Flow|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252474|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252475|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252476|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252477|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252478|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252479|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252480|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252481|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252482|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252483|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252484|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252485|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252486|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252487|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252488|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252702|NCT01026454|O1|Outcome|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
252489|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252490|NCT01027195|E2|Reported Event|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
252491|NCT01027195|E1|Reported Event|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
252492|NCT01026974|B5|Baseline|Total|Total of all reporting groups
252493|NCT01026974|B4|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252494|NCT01026974|B3|Baseline|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252495|NCT01026974|B2|Baseline|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252496|NCT01026974|B1|Baseline|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252497|NCT01026974|P4|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252498|NCT01026974|P3|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252499|NCT01026974|P2|Participant Flow|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252500|NCT01026974|P1|Participant Flow|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252501|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252502|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252503|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252504|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252505|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252506|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252507|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252508|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252509|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252510|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252511|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252512|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252513|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252514|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252515|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252516|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252517|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252518|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252519|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252520|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252521|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252522|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252523|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252524|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252525|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252526|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252527|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252528|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252529|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252530|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252531|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252532|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252533|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252534|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252535|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252536|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252537|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252538|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252539|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252540|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252541|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252542|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252543|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252544|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252545|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252546|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252547|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252548|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252549|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252550|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252551|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252552|NCT01026974|E4|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
252553|NCT01026974|E3|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
252554|NCT01026974|E2|Reported Event|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
252555|NCT01026974|E1|Reported Event|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
252556|NCT01026948|B1|Baseline|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
252557|NCT01026948|P1|Participant Flow|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
252558|NCT01026948|O1|Outcome|Acceptability|Maternal views were assessed using semi-structured diaries
252559|NCT01026948|O1|Outcome|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
252560|NCT01026948|E1|Reported Event|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
252561|NCT01026909|B3|Baseline|Total|Total of all reporting groups
252562|NCT01026909|B2|Baseline|Control|observation
252563|NCT01026909|B1|Baseline|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
252564|NCT01026909|P2|Participant Flow|Control|Observation
252565|NCT01026909|P1|Participant Flow|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
252566|NCT01026909|O2|Outcome|Control|Observation
252567|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
252568|NCT01026909|O2|Outcome|Control|Observation
252569|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
252570|NCT01026909|E2|Reported Event|Control|Observation
252571|NCT01026909|E1|Reported Event|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
252572|NCT01026844|B3|Baseline|Total|Total of all reporting groups
252573|NCT01026844|B2|Baseline|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252574|NCT01026844|B1|Baseline|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252575|NCT01026844|P2|Participant Flow|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252576|NCT01026844|P1|Participant Flow|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252577|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252578|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252579|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252580|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252581|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252582|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252583|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252584|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252585|NCT01026844|E2|Reported Event|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
252703|NCT01026454|E2|Reported Event|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
252586|NCT01026844|E1|Reported Event|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
252587|NCT01026831|B3|Baseline|Total|Total of all reporting groups
252588|NCT01026831|B2|Baseline|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
252589|NCT01026831|B1|Baseline|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
252590|NCT01026831|P2|Participant Flow|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
252591|NCT01026831|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
252592|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
252593|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
252594|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
252595|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
252596|NCT01026831|E2|Reported Event|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
252597|NCT01026831|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
252598|NCT01026818|B4|Baseline|Total|Total of all reporting groups
252599|NCT01026818|B3|Baseline|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252600|NCT01026818|B2|Baseline|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252601|NCT01026818|B1|Baseline|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252602|NCT01026818|P4|Participant Flow|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252603|NCT01026818|P3|Participant Flow|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252604|NCT01026818|P2|Participant Flow|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252605|NCT01026818|P1|Participant Flow|Screen - BNSRP|BNSRP surgery during Screening Period.
252606|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252607|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252608|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252609|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252610|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252611|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252612|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252613|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252614|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252615|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252616|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252617|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252700|NCT01026454|P1|Participant Flow|Acyclovir Then Valacyclovir|Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
252618|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252619|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252620|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252621|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252622|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252623|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252624|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252625|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252626|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252627|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252628|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252629|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252630|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252631|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252632|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252633|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252634|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252635|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252636|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252637|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252638|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252639|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252640|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252641|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252642|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252643|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252644|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252645|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252646|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252647|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252648|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252649|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252650|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252651|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252652|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252653|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252654|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252655|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252656|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252657|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252658|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252659|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252660|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252661|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252662|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252663|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252664|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252665|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252666|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252667|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252668|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252669|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252670|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252671|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252672|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252673|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252674|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252675|NCT01026818|E7|Reported Event|Placebo (Open-Label Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252676|NCT01026818|E6|Reported Event|Tadalfil 20 mg PRN (Open-Label Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252677|NCT01026818|E5|Reported Event|Tadalafil 5 mg OaD (Open-Label Period)|Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
252678|NCT01026818|E4|Reported Event|Placebo (Double-Blind Period/Washout Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
252679|NCT01026818|E3|Reported Event|Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
252680|NCT01026818|E2|Reported Event|Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
252681|NCT01026818|E1|Reported Event|Screen - BNSRP|Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
252682|NCT01026805|B1|Baseline|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252683|NCT01026805|P1|Participant Flow|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252684|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252685|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252686|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252687|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252688|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252689|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252690|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252691|NCT01026805|E1|Reported Event|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
252692|NCT01026792|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
252693|NCT01026792|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
252694|NCT01026792|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
252695|NCT01026792|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
252696|NCT01026454|B3|Baseline|Total|Total of all reporting groups
252697|NCT01026454|B2|Baseline|Valacyclovir Then Acyclovir|valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
252698|NCT01026454|B1|Baseline|Acyclovir Then Valacyclovir|acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
252699|NCT01026454|P2|Participant Flow|Valacyclovir Then Acyclovir|Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
252701|NCT01026454|O2|Outcome|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
252704|NCT01026454|E1|Reported Event|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
252705|NCT01026402|B18|Baseline|Total|Total of all reporting groups
252706|NCT01026402|B17|Baseline|Part A 100mg BD Soln Cont|Continuous BD dosing
252707|NCT01026402|B16|Baseline|Part A 70mg BD Soln Cont|Continuous BD dosing
252708|NCT01026402|B15|Baseline|Part B 170mg BD Tab Int|Intermittent BD dosing
252709|NCT01026402|B14|Baseline|Part B 125mg BD Tab Int|Intermittent BD dosing
252710|NCT01026402|B13|Baseline|Part A 225mg BD Tab Int|Intermittent BD dosing
252711|NCT01026402|B12|Baseline|Part A 170mg BD Tab Int|Intermittent BD dosing
252712|NCT01026402|B11|Baseline|Part A 125mg BD Tab Int|Intermittent BD dosing
252713|NCT01026402|B10|Baseline|Part A 100mg BD Tab Int|Intermittent BD dosing
252714|NCT01026402|B9|Baseline|Part A 175mg QD Tab Cont|Continuous QD dosing
252715|NCT01026402|B8|Baseline|Part A 125mg QD Tab Cont|Continuous QD dosing
252716|NCT01026402|B7|Baseline|Part A 100mg QD Tab Cont|Continuous QD dosing
252717|NCT01026402|B6|Baseline|Part A 125mg QD Soln Cont|Continuous QD dosing
252718|NCT01026402|B5|Baseline|Part A 75mg QD Soln Cont|Continuous QD dosing
252719|NCT01026402|B4|Baseline|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252720|NCT01026402|B3|Baseline|Part B 50mg BD Soln Cont|Continuous BD dosing
252721|NCT01026402|B2|Baseline|Part A 50mg BD Soln Cont|Continuous BD dosing
252722|NCT01026402|B1|Baseline|Part A 25mg BD Soln Cont|Continuous BD dosing
252723|NCT01026402|P17|Participant Flow|Part A 100mg BD Soln Cont|Continuous BD dosing
252724|NCT01026402|P16|Participant Flow|Part A 70mg BD Soln Cont|Continuous BD dosing
252725|NCT01026402|P15|Participant Flow|Part B 170mg BD Tab Int|Intermittent BD dosing
252726|NCT01026402|P14|Participant Flow|Part B 125mg BD Tab Int|Intermittent BD dosing
252727|NCT01026402|P13|Participant Flow|Part A 225mg BD Tab Int|Intermittent BD dosing
252728|NCT01026402|P12|Participant Flow|Part A 170mg BD Tab Int|Intermittent BD dosing
252729|NCT01026402|P11|Participant Flow|Part A 125mg BD Tab Int|Intermittent BD dosing
252730|NCT01026402|P10|Participant Flow|Part A 100mg BD Tab Int|Intermittent BD dosing
252731|NCT01026402|P9|Participant Flow|Part A 175mg QD Tab Cont|Continuous QD dosing
252732|NCT01026402|P8|Participant Flow|Part A 125mg QD Tab Cont|Continuous QD dosing
252733|NCT01026402|P7|Participant Flow|Part A 100mg QD Tab Cont|Continuous QD dosing
252734|NCT01026402|P6|Participant Flow|Part A 125mg QD Soln Cont|Continuous QD dosing
252735|NCT01026402|P5|Participant Flow|Part A 75mg QD Soln Cont|Continuous QD dosing
252736|NCT01026402|P4|Participant Flow|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252737|NCT01026402|P3|Participant Flow|Part B 50mg BD Soln Cont|Continuous BD dosing
252738|NCT01026402|P2|Participant Flow|Part A 50mg BD Soln Cont|Continuous BD dosing
252739|NCT01026402|P1|Participant Flow|Part A 25mg BD Soln Cont|Continuous BD dosing
252740|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252741|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252742|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252743|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252744|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252745|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252746|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252747|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252748|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252749|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252750|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252751|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252752|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252753|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252754|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252755|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252756|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252757|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252758|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252759|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252760|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252761|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252762|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252763|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252764|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252765|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252766|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252767|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252768|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252769|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252770|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252771|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252772|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252773|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252774|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252775|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252776|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252780|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252781|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252782|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252783|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252784|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252785|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252786|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252787|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252788|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252789|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252790|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252791|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252792|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252793|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252794|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252795|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252796|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252797|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252798|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252799|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252800|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252801|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252802|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252803|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252804|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252805|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252806|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252807|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252808|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252809|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252810|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252811|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252812|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252813|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252814|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252815|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252816|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252817|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252818|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252819|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252820|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252821|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252822|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252823|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252824|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252825|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252826|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252827|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252828|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252829|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252830|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252831|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252832|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252833|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252834|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252835|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252836|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252837|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252838|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252839|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252840|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252841|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252842|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252843|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252844|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252845|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252846|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252847|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252848|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252849|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252850|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252851|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252852|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252853|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252854|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252855|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252856|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252857|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252858|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252859|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252860|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252861|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252862|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252863|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252864|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252865|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252866|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252867|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252868|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252869|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252870|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252871|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252872|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252873|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252874|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252875|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252876|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252877|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252878|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252879|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252880|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252881|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252882|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252883|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252884|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252885|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252886|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252887|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252888|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252889|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252890|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252891|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252892|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252893|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252894|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252895|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252896|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252897|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252898|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252899|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252900|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252901|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252902|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252903|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252904|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252905|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252906|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252907|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252908|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252909|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252910|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252911|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252912|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252913|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252914|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252915|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252916|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252917|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252918|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252919|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252920|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252921|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252922|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252923|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252924|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252925|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252926|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252927|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252928|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252929|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252930|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252931|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252932|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252933|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252934|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252935|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252936|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252937|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252938|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252939|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252940|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252941|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252942|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252943|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252944|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252945|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252946|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252947|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252948|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252949|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252950|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252951|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252952|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252953|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252954|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252955|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252956|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252957|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252958|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252959|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252960|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252961|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252962|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252963|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252964|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252965|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252966|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252967|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252968|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252969|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252970|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252971|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252972|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252973|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252974|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252975|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
252976|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
252977|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252978|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252979|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252980|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252981|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252982|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
252983|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
252984|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
252985|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
252986|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
252987|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
252988|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
252989|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
252990|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
252991|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
252992|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
252993|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
252994|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
252995|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
252996|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
252997|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
252998|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
252999|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
253000|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
253001|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
253002|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
253003|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
253004|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
253005|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
253006|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
253007|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
253008|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
253009|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
253010|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
253011|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
253012|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
253013|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
253014|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
253015|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
253016|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
253017|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
253018|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
253019|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
253020|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
253021|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
253022|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
253023|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
253024|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
253025|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
253026|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
253027|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
253028|NCT01026402|E18|Reported Event|Part B - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
253029|NCT01026402|E17|Reported Event|Part B - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
253030|NCT01026402|E16|Reported Event|Part B - AZD2014 BD 50 mg Tablet Fed/Fasted|Continuous BD dosing
253031|NCT01026402|E15|Reported Event|Part B - AZD2014 50 mg BD Tablet Fasted/Fed|Continuous BD dosing
253032|NCT01026402|E14|Reported Event|Part B - AZD2014 50 mg BD Solution|Continuous BD dosing
253033|NCT01026402|E13|Reported Event|Part A - Intermittent AZD2014 225 mg BD Tablet|Intermittent BD dosing
253034|NCT01026402|E12|Reported Event|Part A - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
253035|NCT01026402|E11|Reported Event|Part A - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
253036|NCT01026402|E10|Reported Event|Part A - Intermittent AZD2014 100 mg BD Tablet|Intermittent BD dosing
253037|NCT01026402|E9|Reported Event|Part A - AZD2014 75 mg QD Solution|Continuous QD dosing
253038|NCT01026402|E8|Reported Event|Part A - AZD2014 70 mg BD Solution|Continuous BD dosing
253039|NCT01026402|E7|Reported Event|Part A - AZD2014 50 mg BD Solution|Continuous BD dosing
253040|NCT01026402|E6|Reported Event|Part A - AZD2014 25 mg BD Solution|Continuous BD dosing
253041|NCT01026402|E5|Reported Event|Part A - AZD2014 175 mg QD Tablet|Continuous QD dosing
253042|NCT01026402|E4|Reported Event|Part A - AZD2014 125 mg QD Tablet|Continuous QD dosing
253043|NCT01026402|E3|Reported Event|Part A - AZD2014 125 mg QD Solution|Continous QD dosing
253044|NCT01026402|E2|Reported Event|Part A - AZD2014 100 mg QD Tablet|Continuous QD dosing
253045|NCT01026402|E1|Reported Event|Part A - AZD2014 100 mg BD Solution|Continuous BD dosing
253046|NCT01026389|B3|Baseline|Total|Total of all reporting groups
253047|NCT01026389|B2|Baseline|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253048|NCT01026389|B1|Baseline|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253049|NCT01026389|P2|Participant Flow|Dotarem|Patients received contrast-enhanced MRA with Dotarem
253050|NCT01026389|P1|Participant Flow|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253051|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253052|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253053|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253054|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253055|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253056|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253057|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253058|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253059|NCT01026389|E2|Reported Event|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
253060|NCT01026389|E1|Reported Event|Gadovist|Patient received contrast-enhanced MRA with Gadovist
253061|NCT01026324|B4|Baseline|Total|Total of all reporting groups
253062|NCT01026324|B3|Baseline|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
253063|NCT01026324|B2|Baseline|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
253064|NCT01026324|B1|Baseline|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
253123|NCT01026038|B4|Baseline|Total|Total of all reporting groups
253065|NCT01026324|P3|Participant Flow|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
253066|NCT01026324|P2|Participant Flow|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
253067|NCT01026324|P1|Participant Flow|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
253068|NCT01026324|O3|Outcome|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
253069|NCT01026324|O2|Outcome|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
253070|NCT01026324|O1|Outcome|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
253071|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
253072|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
253073|NCT01026324|E1|Reported Event|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
253074|NCT01026194|B3|Baseline|Total|Total of all reporting groups
253075|NCT01026194|B2|Baseline|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253076|NCT01026194|B1|Baseline|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253077|NCT01026194|P2|Participant Flow|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253078|NCT01026194|P1|Participant Flow|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253079|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253080|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253081|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253082|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253083|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253084|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253085|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253086|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
253087|NCT01026194|E4|Reported Event|Teneli/Teneli + Pio (Data Through Week 52)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
253088|NCT01026194|E3|Reported Event|Placebo/Teneli + Pio (Data From Week 12 to Week 52)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
253089|NCT01026194|E2|Reported Event|Teneli/Teneli + Pio (Data Through Week 12)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
253090|NCT01026194|E1|Reported Event|Placebo/Teneli + Pio (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
253091|NCT01026142|B3|Baseline|Total|Total of all reporting groups
253092|NCT01026142|B2|Baseline|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
253093|NCT01026142|B1|Baseline|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
253124|NCT01026038|B3|Baseline|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253094|NCT01026142|P2|Participant Flow|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253095|NCT01026142|P1|Participant Flow|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253096|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253097|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253098|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253099|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253100|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253101|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253102|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253103|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253104|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253105|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253106|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253107|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253108|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253109|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253110|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253111|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253112|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
253113|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
253114|NCT01026142|E2|Reported Event|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
253115|NCT01026142|E1|Reported Event|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
253116|NCT01026103|B1|Baseline|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253117|NCT01026103|P1|Participant Flow|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253118|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253119|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253120|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253121|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
253122|NCT01026103|E1|Reported Event|Tri Staple|This is a single arm study.
253125|NCT01026038|B2|Baseline|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253126|NCT01026038|B1|Baseline|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253127|NCT01026038|P3|Participant Flow|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253128|NCT01026038|P2|Participant Flow|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253129|NCT01026038|P1|Participant Flow|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253130|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253131|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253132|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253133|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253134|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253135|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253136|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253137|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253138|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253139|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253140|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253141|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253142|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253143|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253144|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253145|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253146|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253147|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253148|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253149|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253150|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253151|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253152|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253153|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253154|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253155|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253228|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253156|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253157|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253158|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253159|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253160|NCT01026038|E3|Reported Event|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
253161|NCT01026038|E2|Reported Event|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
253162|NCT01026038|E1|Reported Event|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
253163|NCT01026012|B1|Baseline|Combined Stress Group|patient's were monitor for approximately 30 minutes following regadenoson infusion
253164|NCT01026012|P1|Participant Flow|Combined Stress Group|Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
253165|NCT01026012|O1|Outcome|Combined Stress Group|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
253166|NCT01026012|E1|Reported Event|Safety|patient's were monitor for approximately 30 minutes following regadenoson infusion
253167|NCT01025843|B11|Baseline|Total|Total of all reporting groups
253168|NCT01025843|B10|Baseline|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
253169|NCT01025843|B9|Baseline|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253170|NCT01025843|B8|Baseline|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
253171|NCT01025843|B7|Baseline|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253172|NCT01025843|B6|Baseline|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253173|NCT01025843|B5|Baseline|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
253174|NCT01025843|B4|Baseline|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
253175|NCT01025843|B3|Baseline|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253176|NCT01025843|B2|Baseline|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
253177|NCT01025843|B1|Baseline|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
253178|NCT01025843|P10|Participant Flow|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
253179|NCT01025843|P9|Participant Flow|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253180|NCT01025843|P8|Participant Flow|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
253181|NCT01025843|P7|Participant Flow|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253182|NCT01025843|P6|Participant Flow|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253183|NCT01025843|P5|Participant Flow|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
253184|NCT01025843|P4|Participant Flow|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
253278|NCT01025817|B3|Baseline|Total|Total of all reporting groups
253185|NCT01025843|P3|Participant Flow|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253186|NCT01025843|P2|Participant Flow|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
253187|NCT01025843|P1|Participant Flow|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
253188|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253189|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253190|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253191|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253192|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253193|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253194|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253195|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253196|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253197|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253198|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253199|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253200|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253201|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253202|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253203|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253204|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253205|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253206|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253207|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253208|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253209|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253210|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253211|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253212|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253213|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253214|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253215|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253216|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253217|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253218|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253219|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253220|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253221|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
253222|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
253223|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253224|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253225|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253226|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253227|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253229|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253230|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253231|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253232|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253233|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253234|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
253235|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
253236|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253237|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253238|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253239|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253240|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253241|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253242|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253243|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253244|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253245|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253246|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253247|NCT01025843|E13|Reported Event|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
253248|NCT01025843|E12|Reported Event|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
253249|NCT01025843|E11|Reported Event|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
253250|NCT01025843|E10|Reported Event|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
253251|NCT01025843|E9|Reported Event|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
253252|NCT01025843|E8|Reported Event|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
253253|NCT01025843|E7|Reported Event|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
253254|NCT01025843|E6|Reported Event|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
253255|NCT01025843|E5|Reported Event|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
253256|NCT01025843|E4|Reported Event|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
253257|NCT01025843|E3|Reported Event|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
253258|NCT01025843|E2|Reported Event|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
253259|NCT01025843|E1|Reported Event|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
253260|NCT01025830|B1|Baseline|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
253261|NCT01025830|P2|Participant Flow|Brand (Zerit/Epivir/Viramune) to Generic (Triomune)|started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
253262|NCT01025830|P1|Participant Flow|Generic (Triomune) to Brand (Zerit/Epivir/Viramune)|Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
253263|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
253264|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
253265|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
253266|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
253267|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
253268|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
253269|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
253270|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
253271|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
253272|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
253273|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
253274|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
253275|NCT01025830|E3|Reported Event|Brand to Generic|started with brand formulation then switched to generic formulation
253276|NCT01025830|E2|Reported Event|Generic to Brand|Started with generic formulation then switched to brand formulation
253277|NCT01025830|E1|Reported Event|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
253279|NCT01025817|B2|Baseline|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253280|NCT01025817|B1|Baseline|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253281|NCT01025817|P2|Participant Flow|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253282|NCT01025817|P1|Participant Flow|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253283|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253284|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253285|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253286|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253287|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253288|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253304|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253305|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253306|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253307|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253289|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253290|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253291|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253292|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253293|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253294|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253295|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253296|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253297|NCT01025817|E2|Reported Event|Mycophenolate Mofetil and Standard Dose Tacrolimus|The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
253298|NCT01025817|E1|Reported Event|Everolimus and Low Dose Tacrolimus|Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
253299|NCT01025635|B3|Baseline|Total|Total of all reporting groups
253300|NCT01025635|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253301|NCT01025635|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253302|NCT01025635|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253303|NCT01025635|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253308|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253309|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253310|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253311|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253312|NCT01025635|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
253313|NCT01025635|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
253314|NCT01025492|B1|Baseline|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
253315|NCT01025492|P1|Participant Flow|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
253316|NCT01025492|O1|Outcome|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
253317|NCT01025492|E1|Reported Event|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
253318|NCT01025336|B6|Baseline|Total|Total of all reporting groups
253319|NCT01025336|B5|Baseline|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253320|NCT01025336|B4|Baseline|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253321|NCT01025336|B3|Baseline|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253322|NCT01025336|B2|Baseline|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253323|NCT01025336|B1|Baseline|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253324|NCT01025336|P5|Participant Flow|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253325|NCT01025336|P4|Participant Flow|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253326|NCT01025336|P3|Participant Flow|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253327|NCT01025336|P2|Participant Flow|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253328|NCT01025336|P1|Participant Flow|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253329|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253330|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253331|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253332|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253333|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
253334|NCT01025336|O1|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
253335|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253336|NCT01025336|O2|Outcome|13vPnC (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
253337|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253338|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253339|NCT01025336|O2|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups)
253340|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253341|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2).
253342|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253343|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253344|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253345|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253346|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253347|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253348|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253349|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253350|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253351|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253424|NCT01024972|B2|Baseline|Placebo|Equiosmolar volume (5% mannitol) every 6 hours for seven days.
253425|NCT01024972|B1|Baseline|Dantrolene|Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
253352|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253353|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253354|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253355|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253356|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253357|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253358|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253359|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253360|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253361|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253362|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253363|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253364|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253365|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253366|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253367|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
253368|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253369|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253370|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253525|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253371|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253372|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253373|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPs Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253374|NCT01025336|E5|Reported Event|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253375|NCT01025336|E4|Reported Event|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253376|NCT01025336|E3|Reported Event|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253377|NCT01025336|E2|Reported Event|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
253378|NCT01025336|E1|Reported Event|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
253379|NCT01025271|B1|Baseline|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
253380|NCT01025271|P1|Participant Flow|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
253381|NCT01025271|O1|Outcome|PK Sampling|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
253382|NCT01025271|O1|Outcome|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
253383|NCT01025271|E1|Reported Event|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
253384|NCT01025232|B3|Baseline|Total|Total of all reporting groups
253385|NCT01025232|B2|Baseline|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253386|NCT01025232|B1|Baseline|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253387|NCT01025232|P2|Participant Flow|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253388|NCT01025232|P1|Participant Flow|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253389|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253390|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253391|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253392|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253393|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253394|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253395|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253396|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253397|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253398|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253399|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253400|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253401|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253402|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253403|NCT01025232|E2|Reported Event|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253404|NCT01025232|E1|Reported Event|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
253405|NCT01025154|B1|Baseline|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
253406|NCT01025154|P1|Participant Flow|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
253407|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
253408|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
253409|NCT01025154|E1|Reported Event|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
253410|NCT01025076|B1|Baseline|StomaphX|Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
253411|NCT01025076|P1|Participant Flow|StomaphX|
253412|NCT01025076|O1|Outcome|StomaphX|
253413|NCT01025076|E1|Reported Event|StomaphX|
253414|NCT01025037|B1|Baseline|Conexa|Rotator cuff repair using Conexa
253415|NCT01025037|P1|Participant Flow|Conexa|Rotator cuff repair using Conexa
253416|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253417|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253418|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253419|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253420|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253421|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
253422|NCT01025037|E1|Reported Event|Conexa|Rotator cuff repair using Conexa
253423|NCT01024972|B3|Baseline|Total|Total of all reporting groups
253426|NCT01024972|P2|Participant Flow|Placebo|"Equiosmolar volume (5% Mannitol)~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
253427|NCT01024972|P1|Participant Flow|Dantrolene|"Dantrolene 1.25mg/kg IV every 6 hours x 7 days~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
253428|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
253429|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
253430|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
253431|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
253432|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days.
253433|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
253434|NCT01024972|E2|Reported Event|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
253435|NCT01024972|E1|Reported Event|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
253436|NCT01024959|B1|Baseline|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
253437|NCT01024959|P1|Participant Flow|Prostate Cancer Gene 3 (PCA3) Assay|PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
253438|NCT01024959|O3|Outcome|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
253439|NCT01024959|O2|Outcome|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
253440|NCT01024959|O1|Outcome|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
253441|NCT01024959|E4|Reported Event|Subjects With no Biopsy Performed|
253442|NCT01024959|E3|Reported Event|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
253443|NCT01024959|E2|Reported Event|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
253444|NCT01024959|E1|Reported Event|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
253445|NCT01024946|B1|Baseline|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
253446|NCT01024946|P1|Participant Flow|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
253447|NCT01024946|O1|Outcome|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
253448|NCT01024946|E1|Reported Event|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
253449|NCT01024855|B1|Baseline|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
256506|NCT01015677|B4|Baseline|Total|Total of all reporting groups
253450|NCT01024855|P1|Participant Flow|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
253451|NCT01024855|O2|Outcome|OptiFree|30 subjects, one eye received Opti-Free RepleniSH MPS(control).
253452|NCT01024855|O1|Outcome|RevitaLens|30 subjects, one eye received RevitaLens MPS (investigational).
253453|NCT01024855|E1|Reported Event|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
253454|NCT01024751|B3|Baseline|Total|Total of all reporting groups
253455|NCT01024751|B2|Baseline|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253456|NCT01024751|B1|Baseline|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253457|NCT01024751|P2|Participant Flow|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253458|NCT01024751|P1|Participant Flow|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253459|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253460|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253461|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253462|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253463|NCT01024751|E2|Reported Event|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253464|NCT01024751|E1|Reported Event|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
253465|NCT01024738|B4|Baseline|Total|Total of all reporting groups
253466|NCT01024738|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
253467|NCT01024738|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
253468|NCT01024738|B1|Baseline|Fluoride Toothpaste|negative control toothpaste
253469|NCT01024738|P3|Participant Flow|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
253470|NCT01024738|P2|Participant Flow|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
253471|NCT01024738|P1|Participant Flow|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
253472|NCT01024738|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
253473|NCT01024738|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
253474|NCT01024738|O1|Outcome|Fluoride Toothpaste|negative control toothpaste
253475|NCT01024738|E3|Reported Event|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
253476|NCT01024738|E2|Reported Event|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
253477|NCT01024738|E1|Reported Event|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
253478|NCT01024608|B3|Baseline|Total|Total of all reporting groups
253479|NCT01024608|B2|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253480|NCT01024608|B1|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253481|NCT01024608|P2|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253482|NCT01024608|P1|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253483|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253484|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253485|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253486|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253487|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253488|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253489|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253490|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253491|NCT01024608|E2|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
253492|NCT01024608|E1|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
253493|NCT01024465|B1|Baseline|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
253494|NCT01024465|P1|Participant Flow|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
253495|NCT01024465|O1|Outcome|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
253496|NCT01024465|E1|Reported Event|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
253497|NCT01024335|B3|Baseline|Total|Total of all reporting groups
253498|NCT01024335|B2|Baseline|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
253499|NCT01024335|B1|Baseline|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
253500|NCT01024335|P2|Participant Flow|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
253501|NCT01024335|P1|Participant Flow|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
253502|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
253503|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
253504|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
253505|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
253506|NCT01024335|E2|Reported Event|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
253507|NCT01024335|E1|Reported Event|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
253508|NCT01024309|B3|Baseline|Total|Total of all reporting groups
253509|NCT01024309|B2|Baseline|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253510|NCT01024309|B1|Baseline|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253511|NCT01024309|P2|Participant Flow|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253512|NCT01024309|P1|Participant Flow|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253513|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253514|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253515|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253516|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253517|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253518|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253519|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253520|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253521|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253522|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253523|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253524|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253526|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253527|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253528|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253529|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
253530|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
253531|NCT01024309|E2|Reported Event|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty: Direct Anterior surgical approach for total hip arthroplasty
253532|NCT01024309|E1|Reported Event|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty: Mini-Posterior surgical approach for total hip arthroplasty
253533|NCT01024244|B6|Baseline|Total|Total of all reporting groups
253534|NCT01024244|B5|Baseline|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253535|NCT01024244|B4|Baseline|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253536|NCT01024244|B3|Baseline|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253537|NCT01024244|B2|Baseline|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253538|NCT01024244|B1|Baseline|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253539|NCT01024244|P5|Participant Flow|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253540|NCT01024244|P4|Participant Flow|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253541|NCT01024244|P3|Participant Flow|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253542|NCT01024244|P2|Participant Flow|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253543|NCT01024244|P1|Participant Flow|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253544|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253545|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253546|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253547|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253548|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253549|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253550|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253551|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253552|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253553|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253554|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253555|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253556|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253557|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253558|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253559|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253560|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253561|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253562|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253563|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253600|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253564|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253565|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253566|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253567|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253568|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253569|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253570|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253571|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253572|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253573|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253574|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253575|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253576|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253577|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253578|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253579|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253580|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253581|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253582|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253583|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253584|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253585|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253586|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253587|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253588|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253589|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253590|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253591|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253592|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253593|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253594|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253595|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253596|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253597|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253598|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253599|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253750|NCT01023672|E1|Reported Event|Armodifinil|150-250 mg armodafinil by mouth daily
253601|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253602|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253603|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253604|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253605|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253606|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253607|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253608|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253609|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253610|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253611|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253612|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253613|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253614|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253615|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253616|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253617|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253618|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253619|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253620|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253621|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253622|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253623|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253624|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253625|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253626|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253627|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253628|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253629|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253630|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253631|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253632|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253633|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253634|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253635|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253636|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253678|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253637|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253638|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253639|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253640|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253641|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253642|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253643|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253644|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253645|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253646|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253647|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253648|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253649|NCT01024244|E5|Reported Event|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
253650|NCT01024244|E4|Reported Event|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253651|NCT01024244|E3|Reported Event|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
253652|NCT01024244|E2|Reported Event|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
253653|NCT01024244|E1|Reported Event|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
253654|NCT01024036|B3|Baseline|Total|Total of all reporting groups
253655|NCT01024036|B2|Baseline|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253656|NCT01024036|B1|Baseline|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253657|NCT01024036|P2|Participant Flow|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253658|NCT01024036|P1|Participant Flow|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253659|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253660|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253661|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253662|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253663|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253664|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253665|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253666|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253667|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253668|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253669|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253670|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253671|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253672|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253673|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253674|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253675|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253676|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253677|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253679|NCT01024036|O1|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253680|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253681|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253682|NCT01024036|E3|Reported Event|Siltuximab + BSC (Unblinded)|Open label 11 mg/kg Siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253683|NCT01024036|E2|Reported Event|Placebo + Best Supportive Care (BSC) (Blinded)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
253684|NCT01024036|E1|Reported Event|Siltuximab + Best Supportive Care (BSC) (Blinded)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
253685|NCT01023841|B3|Baseline|Total|Total of all reporting groups
253686|NCT01023841|B2|Baseline|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253687|NCT01023841|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253688|NCT01023841|P2|Participant Flow|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253689|NCT01023841|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253690|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253691|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253692|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253693|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253694|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253695|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253696|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253697|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253698|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253699|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253700|NCT01023841|E2|Reported Event|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253701|NCT01023841|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
253702|NCT01023815|B5|Baseline|Total|Total of all reporting groups
253703|NCT01023815|B4|Baseline|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253704|NCT01023815|B3|Baseline|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253705|NCT01023815|B2|Baseline|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
253706|NCT01023815|B1|Baseline|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
253751|NCT01023659|B4|Baseline|Total|Total of all reporting groups
253707|NCT01023815|P4|Participant Flow|Randomized: Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253708|NCT01023815|P3|Participant Flow|Randomized: Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253709|NCT01023815|P2|Participant Flow|Randomized: Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
253710|NCT01023815|P1|Participant Flow|Pre-randomized: Not-randomization Patients (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
253711|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253712|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253713|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253714|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253715|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253716|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253717|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253718|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253719|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253720|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253748|NCT01023672|P1|Participant Flow|Armodifinil|150-250 mg armodafinil by mouth daily
253749|NCT01023672|O1|Outcome|Armodifinil|150-250 mg armodafinil by mouth daily
256727|NCT01014624|P2|Participant Flow|Clopidogrel|Clopidogrel 75 mg daily
253721|NCT01023815|O3|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253722|NCT01023815|O2|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253723|NCT01023815|O1|Outcome|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
253724|NCT01023815|E4|Reported Event|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
253725|NCT01023815|E3|Reported Event|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
253726|NCT01023815|E2|Reported Event|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
253727|NCT01023815|E1|Reported Event|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP) and described with respect to baseline characteristics, treatment and outcome variables."
253728|NCT01023776|B1|Baseline|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
253729|NCT01023776|P1|Participant Flow|Live Monovalent H1N1 Vaccine|Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
253730|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
253731|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
253732|NCT01023776|E1|Reported Event|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
253733|NCT01023724|B3|Baseline|Total|Total of all reporting groups
253734|NCT01023724|B2|Baseline|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
253735|NCT01023724|B1|Baseline|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
253736|NCT01023724|P2|Participant Flow|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
253737|NCT01023724|P1|Participant Flow|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
253738|NCT01023724|O2|Outcome|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
253739|NCT01023724|O1|Outcome|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
253740|NCT01023724|E2|Reported Event|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
253741|NCT01023724|E1|Reported Event|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
253742|NCT01023711|B1|Baseline|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
253743|NCT01023711|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
253744|NCT01023711|O1|Outcome|Inactivated H1N1 Vaccine|Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
253745|NCT01023711|O1|Outcome|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
253746|NCT01023711|E1|Reported Event|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
253747|NCT01023672|B1|Baseline|Armodifinil|150-250 mg armodafinil by mouth daily
253752|NCT01023659|B3|Baseline|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
253753|NCT01023659|B2|Baseline|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253754|NCT01023659|B1|Baseline|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253755|NCT01023659|P3|Participant Flow|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
253756|NCT01023659|P2|Participant Flow|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253757|NCT01023659|P1|Participant Flow|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253758|NCT01023659|O1|Outcome|All Eligible Participants|All participants who were eligible to receive medication
253759|NCT01023659|O3|Outcome|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
253760|NCT01023659|O2|Outcome|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253761|NCT01023659|O1|Outcome|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253762|NCT01023659|E3|Reported Event|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
253763|NCT01023659|E2|Reported Event|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253764|NCT01023659|E1|Reported Event|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
253765|NCT01023581|B8|Baseline|Total|Total of all reporting groups
253766|NCT01023581|B7|Baseline|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253767|NCT01023581|B6|Baseline|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253768|NCT01023581|B5|Baseline|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253769|NCT01023581|B4|Baseline|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253770|NCT01023581|B3|Baseline|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253771|NCT01023581|B2|Baseline|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253772|NCT01023581|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253773|NCT01023581|P7|Participant Flow|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253774|NCT01023581|P6|Participant Flow|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253775|NCT01023581|P5|Participant Flow|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253776|NCT01023581|P4|Participant Flow|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253777|NCT01023581|P3|Participant Flow|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253778|NCT01023581|P2|Participant Flow|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253779|NCT01023581|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253780|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253781|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253782|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253783|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253784|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
256728|NCT01014624|P1|Participant Flow|Prasugrel|Prasugrel 10 mg daily
253785|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253786|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253787|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253788|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253789|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253790|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253791|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253792|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253793|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253794|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253795|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253796|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253797|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253798|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253799|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253800|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253801|NCT01023581|E7|Reported Event|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
253802|NCT01023581|E6|Reported Event|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
253803|NCT01023581|E5|Reported Event|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
253804|NCT01023581|E4|Reported Event|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
253805|NCT01023581|E3|Reported Event|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253806|NCT01023581|E2|Reported Event|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253807|NCT01023581|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
253808|NCT01023568|B4|Baseline|Total|Total of all reporting groups
253809|NCT01023568|B3|Baseline|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253810|NCT01023568|B2|Baseline|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253811|NCT01023568|B1|Baseline|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253812|NCT01023568|P3|Participant Flow|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253813|NCT01023568|P2|Participant Flow|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253814|NCT01023568|P1|Participant Flow|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253815|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253816|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253817|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253818|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253819|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253820|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253821|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253822|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253823|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253824|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253825|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253895|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253826|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253827|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253828|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253829|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253830|NCT01023568|E3|Reported Event|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
253831|NCT01023568|E2|Reported Event|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
253832|NCT01023568|E1|Reported Event|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
253833|NCT01023516|B3|Baseline|Total|Total of all reporting groups
253834|NCT01023516|B2|Baseline|Placebo|Matched Placebo Tablets
253835|NCT01023516|B1|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253836|NCT01023516|P2|Participant Flow|Placebo|Matched Placebo Tablets
253837|NCT01023516|P1|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253838|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253839|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253840|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253841|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253842|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253843|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253844|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253845|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253846|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253847|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253848|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253849|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253850|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253851|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253852|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253853|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253854|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253855|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253856|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253857|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253858|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253859|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253860|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253861|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253862|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253863|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253864|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253865|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253866|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253867|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253868|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253869|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253870|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253871|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253872|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253873|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253874|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253875|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253876|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253877|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253878|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253879|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253880|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253881|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253882|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253883|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253884|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253885|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253886|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253887|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253888|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253889|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253890|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253891|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253892|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253893|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253894|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253897|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253898|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253899|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253900|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253901|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253902|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253903|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253904|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253905|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253906|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253907|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253908|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253909|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253910|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253911|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253912|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
253913|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253914|NCT01023516|E2|Reported Event|Placebo|Matched Placebo Tablets
253915|NCT01023516|E1|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
253916|NCT01023308|B3|Baseline|Total|Total of all reporting groups
253917|NCT01023308|B2|Baseline|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253918|NCT01023308|B1|Baseline|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253919|NCT01023308|P2|Participant Flow|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253920|NCT01023308|P1|Participant Flow|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253921|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253922|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253923|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253924|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253925|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253926|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253927|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253928|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253929|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253930|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253931|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253932|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253933|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253934|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253935|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253936|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253937|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253938|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253939|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253940|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253941|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
253942|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253943|NCT01023308|E2|Reported Event|PBO+BTZ|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
253944|NCT01023308|E1|Reported Event|PAN+BTZ|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
253945|NCT01023256|B5|Baseline|Total|Total of all reporting groups
253946|NCT01023256|B4|Baseline|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253947|NCT01023256|B3|Baseline|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253948|NCT01023256|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253949|NCT01023256|B1|Baseline|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253950|NCT01023256|P4|Participant Flow|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
253951|NCT01023256|P3|Participant Flow|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253952|NCT01023256|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253953|NCT01023256|P1|Participant Flow|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253954|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253955|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253956|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253957|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253958|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253959|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253960|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253961|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253962|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253963|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253964|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253965|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253966|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253967|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253968|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253969|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253970|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253971|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253972|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253973|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253974|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253975|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253976|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253977|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253978|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253979|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253980|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253981|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253982|NCT01023256|O5|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
253983|NCT01023256|O4|Outcome|Pooled Active|All patients receiving MOR103 at any dose
253984|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253985|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253986|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253987|NCT01023256|E5|Reported Event|Pooled Placebo|Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
253988|NCT01023256|E4|Reported Event|Pooled Active|All patients receiving MOR103 at any dose
253989|NCT01023256|E3|Reported Event|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253990|NCT01023256|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253991|NCT01023256|E1|Reported Event|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
253992|NCT01023217|B3|Baseline|Total|Total of all reporting groups
253993|NCT01023217|B2|Baseline|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
253994|NCT01023217|B1|Baseline|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
253995|NCT01023217|P2|Participant Flow|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
253996|NCT01023217|P1|Participant Flow|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
253997|NCT01023217|O2|Outcome|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
253998|NCT01023217|O1|Outcome|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
253999|NCT01023217|E2|Reported Event|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
254000|NCT01023217|E1|Reported Event|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
254001|NCT01023178|B4|Baseline|Total|Total of all reporting groups
254002|NCT01023178|B3|Baseline|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
254003|NCT01023178|B2|Baseline|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254004|NCT01023178|B1|Baseline|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254005|NCT01023178|P3|Participant Flow|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
254006|NCT01023178|P2|Participant Flow|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254007|NCT01023178|P1|Participant Flow|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254008|NCT01023178|O3|Outcome|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
254009|NCT01023178|O2|Outcome|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254010|NCT01023178|O1|Outcome|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254011|NCT01023178|E3|Reported Event|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
254012|NCT01023178|E2|Reported Event|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254013|NCT01023178|E1|Reported Event|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
254014|NCT01023074|B4|Baseline|Total|Total of all reporting groups
254015|NCT01023074|B3|Baseline|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254111|NCT01022398|O2|Outcome|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
254016|NCT01023074|B2|Baseline|MS:Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254017|NCT01023074|B1|Baseline|Non-MS Control|Non-MS control group
254018|NCT01023074|P3|Participant Flow|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254019|NCT01023074|P2|Participant Flow|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254020|NCT01023074|P1|Participant Flow|Non-MS Control|Non-MS control group
254021|NCT01023074|O3|Outcome|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254022|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254023|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
254024|NCT01023074|O3|Outcome|MS: Control Activity|MS group not receiving auditory training, doing control activity
254025|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254026|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
254027|NCT01023074|O3|Outcome|Arm 3|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254028|NCT01023074|O2|Outcome|Arm 2|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254029|NCT01023074|O1|Outcome|Arm 1|Non-MS control group
254030|NCT01023074|E3|Reported Event|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254031|NCT01023074|E2|Reported Event|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
254032|NCT01023074|E1|Reported Event|Non-MS Control|Non-MS control group
254033|NCT01023035|B4|Baseline|Total|Total of all reporting groups
254034|NCT01023035|B3|Baseline|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
254035|NCT01023035|B2|Baseline|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
254036|NCT01023035|B1|Baseline|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
254037|NCT01023035|P3|Participant Flow|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
254038|NCT01023035|P2|Participant Flow|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
254039|NCT01023035|P1|Participant Flow|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
254040|NCT01023035|O3|Outcome|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
254041|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
254042|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
254043|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
254044|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
254045|NCT01023035|E3|Reported Event|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
254046|NCT01023035|E2|Reported Event|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
254047|NCT01023035|E1|Reported Event|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
254048|NCT01023022|B1|Baseline|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
254049|NCT01023022|P1|Participant Flow|Medtronic CareLink® Network|"Patients with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
254050|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
254051|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
254052|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
254053|NCT01023022|E1|Reported Event|Patients With Implanted ICD or CRT-D Devices|Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
254054|NCT01022502|B1|Baseline|All Participants (Refined/Crude Ointment)|Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8.
254055|NCT01022502|P1|Participant Flow|All Participants|In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks.
254056|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254057|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254058|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254059|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254060|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254061|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254062|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254063|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254064|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254065|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
254066|NCT01022502|E2|Reported Event|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
254067|NCT01022502|E1|Reported Event|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
254068|NCT01022996|B1|Baseline|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254069|NCT01022996|P1|Participant Flow|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254070|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254071|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254072|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254073|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254074|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254075|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254112|NCT01022398|O1|Outcome|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
254113|NCT01022398|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
254114|NCT01022307|B3|Baseline|Total|Total of all reporting groups
254115|NCT01022307|B2|Baseline|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
254116|NCT01022307|B1|Baseline|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
254076|NCT01022996|E1|Reported Event|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
254077|NCT01022762|B3|Baseline|Total|Total of all reporting groups
254078|NCT01022762|B2|Baseline|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254079|NCT01022762|B1|Baseline|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254080|NCT01022762|P2|Participant Flow|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254081|NCT01022762|P1|Participant Flow|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254082|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254083|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254084|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254085|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254086|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254087|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254088|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254089|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254090|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254091|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254092|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254093|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254094|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254095|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254096|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254097|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254098|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254099|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254100|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254101|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254102|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254103|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254104|NCT01022762|E2|Reported Event|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
254105|NCT01022762|E1|Reported Event|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
254106|NCT01022398|B3|Baseline|Total|Total of all reporting groups
254107|NCT01022398|B2|Baseline|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
254108|NCT01022398|B1|Baseline|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
254109|NCT01022398|P2|Participant Flow|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
254110|NCT01022398|P1|Participant Flow|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
254117|NCT01022307|P2|Participant Flow|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI.
254118|NCT01022307|P1|Participant Flow|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
254119|NCT01022307|O2|Outcome|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
254120|NCT01022307|O1|Outcome|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
254121|NCT01022307|E2|Reported Event|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
254122|NCT01022307|E1|Reported Event|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
254123|NCT01022242|B3|Baseline|Total|Total of all reporting groups
254124|NCT01022242|B2|Baseline|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
254125|NCT01022242|B1|Baseline|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
254126|NCT01022242|P2|Participant Flow|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
254127|NCT01022242|P1|Participant Flow|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless."
254128|NCT01022242|O2|Outcome|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
254129|NCT01022242|O1|Outcome|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
254130|NCT01022242|E2|Reported Event|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
254131|NCT01022242|E1|Reported Event|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
254132|NCT01022203|B3|Baseline|Total|Total of all reporting groups
254133|NCT01022203|B2|Baseline|Arm 2|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
254134|NCT01022203|B1|Baseline|Arm 1|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
254135|NCT01022203|P2|Participant Flow|PTSD Family Education|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
254136|NCT01022203|P1|Participant Flow|Structured Approach Therapy|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
254137|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
254138|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
254139|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
254140|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
254141|NCT01022203|O2|Outcome|PTSD Family Education|Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
254142|NCT01022203|O1|Outcome|Structured Approach Therapy|Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
254241|NCT01021852|E4|Reported Event|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254471|NCT01021007|P1|Participant Flow|Negative Control Rinse|Placebo mouthrinse
254143|NCT01022203|E2|Reported Event|PTSD Family Education (PFE)|"Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.~PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included."
254144|NCT01022203|E1|Reported Event|Structured Approach Therapy (SAT)|"Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.~Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication."
254145|NCT01022190|B1|Baseline|Etoricoxib|
254146|NCT01022190|P1|Participant Flow|Etoricoxib, 90 mg, Orally, Ones a Day|Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation.
254147|NCT01022190|O1|Outcome|Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period|Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
254148|NCT01022190|E1|Reported Event|Etoricoxib|
254149|NCT01022112|B6|Baseline|Total|Total of all reporting groups
254150|NCT01022112|B5|Baseline|Placebo|TA-7284 Placebo, once daily for 12 weeks
254151|NCT01022112|B4|Baseline|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
254152|NCT01022112|B3|Baseline|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
254153|NCT01022112|B2|Baseline|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
254154|NCT01022112|B1|Baseline|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
254155|NCT01022112|P5|Participant Flow|Placebo|TA-7284 Placebo, once daily for 12 weeks
254156|NCT01022112|P4|Participant Flow|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
254157|NCT01022112|P3|Participant Flow|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
254158|NCT01022112|P2|Participant Flow|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
254159|NCT01022112|P1|Participant Flow|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
254160|NCT01022112|O5|Outcome|Placebo|TA-7284 Placebo, once daily for 12 weeks
254161|NCT01022112|O4|Outcome|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
254162|NCT01022112|O3|Outcome|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
254163|NCT01022112|O2|Outcome|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
254164|NCT01022112|O1|Outcome|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
254165|NCT01022112|E5|Reported Event|Placebo|TA-7284 Placebo, once daily for 12 weeks
254166|NCT01022112|E4|Reported Event|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
254167|NCT01022112|E3|Reported Event|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
254168|NCT01022112|E2|Reported Event|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
254169|NCT01022112|E1|Reported Event|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
254170|NCT01022073|B3|Baseline|Total|Total of all reporting groups
254171|NCT01022073|B2|Baseline|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
254172|NCT01022073|B1|Baseline|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
254173|NCT01022073|P2|Participant Flow|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
254174|NCT01022073|P1|Participant Flow|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
254175|NCT01022073|O2|Outcome|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
254176|NCT01022073|O1|Outcome|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
254177|NCT01022073|E2|Reported Event|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
254178|NCT01022073|E1|Reported Event|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
254179|NCT01021878|B3|Baseline|Total|Total of all reporting groups
254180|NCT01021878|B2|Baseline|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
254181|NCT01021878|B1|Baseline|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
254182|NCT01021878|P2|Participant Flow|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~N=27"
254183|NCT01021878|P1|Participant Flow|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~N=33"
254184|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
254185|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
254186|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
254187|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
254188|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
254242|NCT01021852|E3|Reported Event|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254189|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
254190|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
254191|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
254192|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
254193|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
254194|NCT01021878|E2|Reported Event|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
254195|NCT01021878|E1|Reported Event|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
254196|NCT01021852|B9|Baseline|Total|Total of all reporting groups
254197|NCT01021852|B8|Baseline|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254198|NCT01021852|B7|Baseline|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254199|NCT01021852|B6|Baseline|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254200|NCT01021852|B5|Baseline|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254201|NCT01021852|B4|Baseline|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254202|NCT01021852|B3|Baseline|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254243|NCT01021852|E2|Reported Event|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254244|NCT01021852|E1|Reported Event|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254203|NCT01021852|B2|Baseline|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254204|NCT01021852|B1|Baseline|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254205|NCT01021852|P8|Participant Flow|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254206|NCT01021852|P7|Participant Flow|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254207|NCT01021852|P6|Participant Flow|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254208|NCT01021852|P5|Participant Flow|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254209|NCT01021852|P4|Participant Flow|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254210|NCT01021852|P3|Participant Flow|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254245|NCT01021813|B3|Baseline|Total|Total of all reporting groups
254472|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
254211|NCT01021852|P2|Participant Flow|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
254212|NCT01021852|P1|Participant Flow|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
254213|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254214|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254215|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254216|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254217|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254218|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254219|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254220|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254221|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254222|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254223|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254224|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254225|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254226|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254227|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254228|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254229|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254230|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254231|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254232|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254233|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254234|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254235|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254236|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254237|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
254238|NCT01021852|E7|Reported Event|Post-Study/Follow-up|Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
254239|NCT01021852|E6|Reported Event|Washout|Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
254240|NCT01021852|E5|Reported Event|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
254473|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
254246|NCT01021813|B2|Baseline|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254247|NCT01021813|B1|Baseline|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254248|NCT01021813|P5|Participant Flow|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
254249|NCT01021813|P4|Participant Flow|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
254250|NCT01021813|P3|Participant Flow|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
254251|NCT01021813|P2|Participant Flow|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254252|NCT01021813|P1|Participant Flow|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254253|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase. Following the Treatment Phase, these participants continued on placebo during the 2-month Randomized Discontinuation Phase.
254254|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase. Following the Treatment Phase, these participants were randomized (at baseline) to suvorexant or placebo during the 2-month Randomized Discontinuation Phase.
254255|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254256|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254257|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254258|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254259|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254260|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254261|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
254262|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254263|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254264|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
254265|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254266|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
254267|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
254268|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254269|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254270|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254301|NCT01021761|E2|Reported Event|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254474|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
254271|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254272|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254273|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254274|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254275|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254276|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254277|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254278|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254279|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254280|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254281|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254282|NCT01021813|E8|Reported Event|Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with dose-matched placebo during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
254283|NCT01021813|E7|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with suvorexant during the 12-Month DB Treatment Period and treatment with dose-matched placebo during the DB the Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
254284|NCT01021813|E6|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up|Following treatment with suvorexant during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
254285|NCT01021813|E5|Reported Event|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
254286|NCT01021813|E4|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
254287|NCT01021813|E3|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
254288|NCT01021813|E2|Reported Event|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
254289|NCT01021813|E1|Reported Event|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
254290|NCT01021761|B4|Baseline|Total|Total of all reporting groups
254291|NCT01021761|B3|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
254292|NCT01021761|B2|Baseline|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254293|NCT01021761|B1|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254294|NCT01021761|P3|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
254295|NCT01021761|P2|Participant Flow|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254296|NCT01021761|P1|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254297|NCT01021761|O3|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
254298|NCT01021761|O2|Outcome|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254299|NCT01021761|O1|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254300|NCT01021761|E3|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
254302|NCT01021761|E1|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
254303|NCT01021683|B1|Baseline|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254304|NCT01021683|P1|Participant Flow|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254305|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254306|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254307|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254308|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254309|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254310|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254311|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254312|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254313|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254314|NCT01021683|E1|Reported Event|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
254315|NCT01021618|B3|Baseline|Total|Total of all reporting groups
254316|NCT01021618|B2|Baseline|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
254317|NCT01021618|B1|Baseline|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
254318|NCT01021618|P2|Participant Flow|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
254319|NCT01021618|P1|Participant Flow|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
254320|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
254321|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
254463|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
254322|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
254323|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
254324|NCT01021618|E2|Reported Event|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
254325|NCT01021618|E1|Reported Event|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
254326|NCT01020526|B1|Baseline|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
254327|NCT01020526|P1|Participant Flow|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
254328|NCT01020526|O1|Outcome|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
254329|NCT01020526|E1|Reported Event|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
254330|NCT01020474|B3|Baseline|Total|Total of all reporting groups
254331|NCT01020474|B2|Baseline|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254332|NCT01020474|B1|Baseline|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254333|NCT01020474|P2|Participant Flow|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254334|NCT01020474|P1|Participant Flow|Pregabalin|Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254335|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254336|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254337|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254338|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254339|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254340|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254341|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254342|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254343|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254344|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254345|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254346|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254347|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254348|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254349|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254350|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254351|NCT01020474|E2|Reported Event|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
254352|NCT01020474|E1|Reported Event|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
254353|NCT01020448|B1|Baseline|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
254354|NCT01020448|P1|Participant Flow|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
254355|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
254356|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
254357|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
254358|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
254359|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
254360|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
254361|NCT01020448|E1|Reported Event|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
254362|NCT01021423|B3|Baseline|Total|Total of all reporting groups
254363|NCT01021423|B2|Baseline|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254364|NCT01021423|B1|Baseline|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254365|NCT01021423|P2|Participant Flow|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254366|NCT01021423|P1|Participant Flow|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254367|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254368|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254369|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254370|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254371|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254372|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254373|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254374|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254375|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254376|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254377|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254378|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254379|NCT01021423|E2|Reported Event|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254475|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
254380|NCT01021423|E1|Reported Event|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
254381|NCT01021332|B1|Baseline|Total Group|Participants who received at least one dose of open-label FDC treatment
254382|NCT01021332|P1|Participant Flow|Total Group|Participants who received at least one dose of open-label FDC treatment
254383|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254384|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254385|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254386|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254387|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254388|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254389|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254390|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254391|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
254392|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254393|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254394|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254395|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254396|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254397|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254398|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254399|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254400|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254401|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254402|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254403|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
254404|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254405|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254406|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254407|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254408|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254409|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
254410|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
254411|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
254412|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
254413|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
254414|NCT01021332|E1|Reported Event|Total Group|Participants who received at least one dose of open-label FDC treatment
254415|NCT01021306|B5|Baseline|Total|Total of all reporting groups
254416|NCT01021306|B4|Baseline|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254417|NCT01021306|B3|Baseline|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254464|NCT01021020|E3|Reported Event|Colchicine 0.5 mg/Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg after an overnight fast of at least 13.5 hours.
254465|NCT01021020|E2|Reported Event|Colchicine 0.6 mg (Fed)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
254418|NCT01021306|B2|Baseline|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254419|NCT01021306|B1|Baseline|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254420|NCT01021306|P4|Participant Flow|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254421|NCT01021306|P3|Participant Flow|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254422|NCT01021306|P2|Participant Flow|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254423|NCT01021306|P1|Participant Flow|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254424|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254425|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254426|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254466|NCT01021020|E1|Reported Event|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6mg after an overnight fast of at least 13.5 hours.
254427|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254428|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254429|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254430|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254431|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254432|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254433|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254434|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254435|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254467|NCT01021007|B3|Baseline|Total|Total of all reporting groups
254468|NCT01021007|B2|Baseline|Iocide Mouthrinse|Experimental mouthrinse
254469|NCT01021007|B1|Baseline|Negative Control Rinse|Placebo mouthrinse
254436|NCT01021306|E4|Reported Event|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
254437|NCT01021306|E3|Reported Event|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
254438|NCT01021306|E2|Reported Event|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
254439|NCT01021306|E1|Reported Event|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
254440|NCT01021215|B3|Baseline|Total|Total of all reporting groups
254441|NCT01021215|B2|Baseline|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254442|NCT01021215|B1|Baseline|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254443|NCT01021215|P2|Participant Flow|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254444|NCT01021215|P1|Participant Flow|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254445|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254446|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254447|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254448|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254449|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254450|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254451|NCT01021215|E2|Reported Event|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
254452|NCT01021215|E1|Reported Event|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
254453|NCT01021020|B1|Baseline|Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid|All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
254454|NCT01021020|P1|Participant Flow|Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid|All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
254455|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
254456|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
254457|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
254458|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasting)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast
254459|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
254460|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasting)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
254461|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
254462|NCT01021020|O2|Outcome|Colchicine (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
254470|NCT01021007|P2|Participant Flow|Iocide Mouthrinse|Experimental mouthrinse
254478|NCT01021007|E2|Reported Event|Iocide Mouthrinse|Experimental mouthrinse
254479|NCT01021007|E1|Reported Event|Negative Control Rinse|Placebo mouthrinse
254480|NCT01020981|B3|Baseline|Total|Total of all reporting groups
254481|NCT01020981|B2|Baseline|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254482|NCT01020981|B1|Baseline|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254483|NCT01020981|P2|Participant Flow|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254484|NCT01020981|P1|Participant Flow|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254485|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
254486|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
254487|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
254488|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
254489|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254490|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254491|NCT01020981|E2|Reported Event|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254492|NCT01020981|E1|Reported Event|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
254493|NCT01020903|B3|Baseline|Total|Total of all reporting groups
254494|NCT01020903|B2|Baseline|Placebo|Placebo: Orally, pre-op
254495|NCT01020903|B1|Baseline|Aprepitant|Aprepitant: 40 mg po pre-op
254496|NCT01020903|P2|Participant Flow|Placebo|Placebo: Orally, pre-op
254497|NCT01020903|P1|Participant Flow|Aprepitant|Aprepitant: 40 mg po pre-op
254498|NCT01020903|O2|Outcome|Placebo|Placebo: Orally, pre-op
254499|NCT01020903|O1|Outcome|Aprepitant|Aprepitant: 40 mg po pre-op
254500|NCT01020903|E2|Reported Event|Placebo|"Placebo: Orally, pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
254501|NCT01020903|E1|Reported Event|Aprepitant|"Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
254502|NCT01020877|B3|Baseline|Total|Total of all reporting groups
254503|NCT01020877|B2|Baseline|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
254504|NCT01020877|B1|Baseline|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
254505|NCT01020877|P2|Participant Flow|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
254506|NCT01020877|P1|Participant Flow|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
254507|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
254508|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
254509|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
254510|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
254511|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
254512|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
254513|NCT01020877|E2|Reported Event|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
254514|NCT01020877|E1|Reported Event|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
254515|NCT01020838|B1|Baseline|Safety Analysis Set|All study participants who received any amount of florbetaben were included in the safety analysis set.
254516|NCT01020838|P1|Participant Flow|All Study Participants|All patients enrolling into the study
254517|NCT01020838|O3|Outcome|2nd Repeat Drug Administration|The analysis set consisted of data from 3 subjects with brain specimens available.
254518|NCT01020838|O2|Outcome|1st Repeat Drug Administration|The analysis set consisted of data from 20 subjects with brain specimens available.
254519|NCT01020838|O1|Outcome|Initial Drug Administration|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
254541|NCT01020799|P3|Participant Flow|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254520|NCT01020838|O2|Outcome|Specificity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
254521|NCT01020838|O1|Outcome|Sensitivity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
254522|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
254523|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
254524|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
254525|NCT01020838|O2|Outcome|Specificity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
254526|NCT01020838|O1|Outcome|Sensitivity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
254527|NCT01020838|E3|Reported Event|2nd Repeat Drug Administration|Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
254528|NCT01020838|E2|Reported Event|1st Repeat Drug Administration|Subjects with TEAEs within 7 days of the 1st repeat drug administration.
254529|NCT01020838|E1|Reported Event|Initial Drug Administration|Subjects with TEAEs within 7 days of the initial administration of florbetaben.
254530|NCT01020812|B1|Baseline|Stereotactic Body Radiotherapy (SBRT)|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254531|NCT01020812|P1|Participant Flow|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254532|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254533|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254534|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254535|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254536|NCT01020812|E1|Reported Event|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
254537|NCT01020799|B4|Baseline|Total|Total of all reporting groups
254538|NCT01020799|B3|Baseline|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254539|NCT01020799|B2|Baseline|Placebo|Placebo matching both AZD7268 and escitalopram
254540|NCT01020799|B1|Baseline|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254542|NCT01020799|P2|Participant Flow|Placebo|Placebo matching both AZD7268 and escitalopram
254543|NCT01020799|P1|Participant Flow|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254544|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254545|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254546|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254547|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254548|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254549|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254550|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254551|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254552|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254553|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254554|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254555|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254556|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254557|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254558|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254559|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254560|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
254561|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254562|NCT01020799|E3|Reported Event|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
254563|NCT01020799|E2|Reported Event|Placebo|Placebo matching both AZD7268 and escitalopram
254564|NCT01020799|E1|Reported Event|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
254565|NCT01020786|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254566|NCT01020786|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254567|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254568|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254569|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254570|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254571|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254572|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254655|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
256729|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
254573|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254574|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254575|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity."
254576|NCT01020786|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
254577|NCT01020773|B3|Baseline|Total|Total of all reporting groups
254578|NCT01020773|B2|Baseline|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
254579|NCT01020773|B1|Baseline|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
254580|NCT01020773|P2|Participant Flow|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
254581|NCT01020773|P1|Participant Flow|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
254582|NCT01020773|O2|Outcome|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
254583|NCT01020773|O1|Outcome|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
254584|NCT01020773|E2|Reported Event|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
254585|NCT01020773|E1|Reported Event|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
254586|NCT01020747|B1|Baseline|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
254587|NCT01020747|P1|Participant Flow|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
254588|NCT01020747|O2|Outcome|Untreated Vocal Fold|Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
254589|NCT01020747|O1|Outcome|Bevacizumab Treated Vocal Fold|Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
254590|NCT01020747|E1|Reported Event|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
254591|NCT01020305|B1|Baseline|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
254592|NCT01020305|P1|Participant Flow|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
254593|NCT01020305|O1|Outcome|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
254656|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254594|NCT01020305|E1|Reported Event|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
254595|NCT01020123|B8|Baseline|Total|Total of all reporting groups
254596|NCT01020123|B7|Baseline|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254597|NCT01020123|B6|Baseline|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254598|NCT01020123|B5|Baseline|Placebo|Placebo add on to metformin
254599|NCT01020123|B4|Baseline|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254600|NCT01020123|B3|Baseline|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254601|NCT01020123|B2|Baseline|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254602|NCT01020123|B1|Baseline|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254603|NCT01020123|P7|Participant Flow|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254604|NCT01020123|P6|Participant Flow|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254605|NCT01020123|P5|Participant Flow|Placebo|Placebo add on to metformin
254606|NCT01020123|P4|Participant Flow|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254607|NCT01020123|P3|Participant Flow|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254608|NCT01020123|P2|Participant Flow|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254609|NCT01020123|P1|Participant Flow|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254610|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254611|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254612|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254613|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254614|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254615|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254616|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254617|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254618|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254619|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254620|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254621|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254622|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254623|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254624|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254625|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254626|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254627|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254628|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254629|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254630|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254631|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254632|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254633|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254634|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254635|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254636|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254637|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254638|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254639|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254640|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254641|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254642|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254643|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254644|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254645|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254646|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254647|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254648|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254649|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254650|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254651|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254652|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254653|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254654|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254658|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254659|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254660|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254661|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254662|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254663|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254664|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254665|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254666|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254667|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254668|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254669|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254670|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254671|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254672|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254673|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254674|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254675|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254676|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254677|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254678|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254679|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254680|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254681|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254682|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254683|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254684|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254685|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254686|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254687|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254688|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254689|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254690|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254691|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254692|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254693|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254694|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254695|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254696|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254697|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254698|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254699|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254700|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254701|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254702|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254703|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254704|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254705|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254706|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254707|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254708|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254709|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254710|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254711|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254712|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254713|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254714|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254715|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254716|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254717|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254718|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254719|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254720|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254721|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254722|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254723|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254724|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254726|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254727|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254728|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254729|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254730|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254731|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254732|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254733|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254734|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254735|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254736|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254737|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254738|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254739|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254740|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254741|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254742|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254743|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254744|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254745|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254746|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254747|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254748|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254749|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254750|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254751|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254752|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254753|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254754|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254755|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254756|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254757|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254758|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254759|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254760|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254761|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254762|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254763|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254764|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254765|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254766|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254767|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254768|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254769|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254770|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254771|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254772|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254773|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254774|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254775|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254776|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254777|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254778|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254779|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254780|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254781|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254782|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254783|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254784|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254785|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254786|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254787|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254788|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254789|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
254790|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254791|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254792|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254793|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
256730|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
254794|NCT01020123|E7|Reported Event|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
254795|NCT01020123|E6|Reported Event|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
254796|NCT01020123|E5|Reported Event|Placebo|Placebo add on to metformin
254797|NCT01020123|E4|Reported Event|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
254798|NCT01020123|E3|Reported Event|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
254799|NCT01020123|E2|Reported Event|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
254800|NCT01020123|E1|Reported Event|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
254801|NCT01020019|B3|Baseline|Total|Total of all reporting groups
254802|NCT01020019|B2|Baseline|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
254803|NCT01020019|B1|Baseline|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
254804|NCT01020019|P2|Participant Flow|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
254805|NCT01020019|P1|Participant Flow|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
254806|NCT01020019|O2|Outcome|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
254807|NCT01020019|O1|Outcome|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
254808|NCT01020019|E2|Reported Event|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
254809|NCT01020019|E1|Reported Event|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
254810|NCT01020006|B4|Baseline|Total|Total of all reporting groups
254811|NCT01020006|B3|Baseline|Gemcitabine/Part B|
254812|NCT01020006|B2|Baseline|(PCI-27483 + Gemcitabine)/Part B|
254813|NCT01020006|B1|Baseline|(PCI-27483 + Gemcitabine)/Part A|
254814|NCT01020006|P3|Participant Flow|Gemcitabine/Part B|Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
254815|NCT01020006|P2|Participant Flow|PCI-27483 + Gemcitabine/Part B|Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
254816|NCT01020006|P1|Participant Flow|PCI-27483 + Gemcitabine/Part A|Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
254817|NCT01020006|O3|Outcome|Gemcitabine/Part B|
254818|NCT01020006|O2|Outcome|(PCI-27483 + Gemcitabine)/Part B|
254819|NCT01020006|O1|Outcome|(PCI-27483 + Gemcitabine)/Part A|
254820|NCT01020006|E3|Reported Event|Gemcitabine/Part B|"Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
254821|NCT01020006|E2|Reported Event|(PCI-27483 + Gemcitabine)/Part B|"Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
254822|NCT01020006|E1|Reported Event|(PCI-27483 + Gemcitabine)/Part A|"Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
254823|NCT01019980|B3|Baseline|Total|Total of all reporting groups
254824|NCT01019980|B2|Baseline|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
254825|NCT01019980|B1|Baseline|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
254826|NCT01019980|P2|Participant Flow|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
254827|NCT01019980|P1|Participant Flow|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
254828|NCT01019980|O2|Outcome|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
254829|NCT01019980|O1|Outcome|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
254830|NCT01019980|E2|Reported Event|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
254831|NCT01019980|E1|Reported Event|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
254832|NCT01019928|B3|Baseline|Total|Total of all reporting groups
254833|NCT01019928|B2|Baseline|Placebo|
254834|NCT01019928|B1|Baseline|AZD1386 95 mg|
254835|NCT01019928|P2|Participant Flow|First Placebo, Then Washout, Then AZD1386|
254836|NCT01019928|P1|Participant Flow|First AZD1386, Then Washout, Then Placebo|
254837|NCT01019928|O2|Outcome|Placebo|
254838|NCT01019928|O1|Outcome|AZD1386 95 mg|
254839|NCT01019928|O2|Outcome|Placebo|
254840|NCT01019928|O1|Outcome|AZD1386 95 mg|
254841|NCT01019928|O2|Outcome|Placebo|
254842|NCT01019928|O1|Outcome|AZD1386 95 mg|
254843|NCT01019928|O2|Outcome|Placebo|
254844|NCT01019928|O1|Outcome|AZD1386 95 mg|
254845|NCT01019928|O2|Outcome|Placebo|
254846|NCT01019928|O1|Outcome|AZD1386 95 mg|
254847|NCT01019928|O2|Outcome|Placebo|
254848|NCT01019928|O1|Outcome|AZD1386 95 mg|
254849|NCT01019928|O2|Outcome|Placebo|
254850|NCT01019928|O1|Outcome|AZD1386 95 mg|
254851|NCT01019928|O2|Outcome|Placebo|
254852|NCT01019928|O1|Outcome|AZD1386 95 mg|
254853|NCT01019928|O2|Outcome|Placebo|
254854|NCT01019928|O1|Outcome|AZD1386 95 mg|
254875|NCT01019707|B1|Baseline|Total Sample|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
254876|NCT01019707|P2|Participant Flow|Placebo, Then Atomoxetine|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
254877|NCT01019707|P1|Participant Flow|Atomoxetine, Then Placebo|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
254878|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254879|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254880|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254881|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254882|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254883|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
254884|NCT01019707|E2|Reported Event|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
254885|NCT01019707|E1|Reported Event|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
254886|NCT01019694|B4|Baseline|Total|Total of all reporting groups
254887|NCT01019694|B3|Baseline|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254888|NCT01019694|B2|Baseline|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254889|NCT01019694|B1|Baseline|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254890|NCT01019694|P3|Participant Flow|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254891|NCT01019694|P2|Participant Flow|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254892|NCT01019694|P1|Participant Flow|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254893|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254894|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254895|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254896|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254897|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254898|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254899|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254900|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254901|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254902|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254903|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254904|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254905|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254906|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254907|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254908|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254909|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254910|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254911|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254912|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254913|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255764|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
254914|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254915|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254916|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254917|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254918|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254919|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254920|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254921|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254922|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254923|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254924|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254925|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254926|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254927|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254928|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254929|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254930|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254931|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254932|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254933|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254934|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254935|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254936|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254937|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254938|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254939|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254940|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254941|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254942|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254943|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254944|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254945|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254946|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254947|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254948|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254949|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254950|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254951|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254952|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254953|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254954|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254955|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254956|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254957|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254958|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254959|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254960|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254961|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254962|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254963|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254964|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254965|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254966|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254967|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254968|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254969|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254970|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254971|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254972|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254973|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254974|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254975|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254976|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254977|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254978|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254979|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254980|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254981|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254982|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254983|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254984|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254985|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254986|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254987|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254988|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254989|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254990|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254991|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254992|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254993|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254994|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254995|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254996|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
254997|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
254998|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
254999|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
255000|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255001|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
255002|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
255003|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255004|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
255005|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
255006|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255007|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
255008|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
255009|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255010|NCT01019694|E3|Reported Event|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
255011|NCT01019694|E2|Reported Event|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
255012|NCT01019694|E1|Reported Event|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
255013|NCT01019486|B4|Baseline|Total|Total of all reporting groups
255014|NCT01019486|B3|Baseline|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
255015|NCT01019486|B2|Baseline|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
255016|NCT01019486|B1|Baseline|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
255017|NCT01019486|P3|Participant Flow|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
255018|NCT01019486|P2|Participant Flow|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
255019|NCT01019486|P1|Participant Flow|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
255020|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
255021|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
255022|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
255063|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255064|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255023|NCT01019486|O1|Outcome|Abnormal MPI Study|These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
255024|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
255025|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
255026|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
255027|NCT01019486|E3|Reported Event|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
255028|NCT01019486|E2|Reported Event|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
255029|NCT01019486|E1|Reported Event|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
255030|NCT01019369|B3|Baseline|Total|Total of all reporting groups
255031|NCT01019369|B2|Baseline|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255032|NCT01019369|B1|Baseline|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255033|NCT01019369|P2|Participant Flow|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255034|NCT01019369|P1|Participant Flow|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255035|NCT01019369|O2|Outcome|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255036|NCT01019369|O1|Outcome|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255037|NCT01019369|E2|Reported Event|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255038|NCT01019369|E1|Reported Event|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
255039|NCT01019317|B1|Baseline|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
255040|NCT01019317|P1|Participant Flow|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
255041|NCT01019317|O1|Outcome|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
255042|NCT01019317|E1|Reported Event|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
255043|NCT01019135|B4|Baseline|Total|Total of all reporting groups
255044|NCT01019135|B3|Baseline|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255045|NCT01019135|B2|Baseline|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255046|NCT01019135|B1|Baseline|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255047|NCT01019135|P3|Participant Flow|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255048|NCT01019135|P2|Participant Flow|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255049|NCT01019135|P1|Participant Flow|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255050|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255051|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255052|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255053|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255054|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255055|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255056|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255057|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255058|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255059|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255060|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255061|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255062|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255113|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
255065|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255066|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255067|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255068|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255069|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255070|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255071|NCT01019135|E3|Reported Event|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255072|NCT01019135|E2|Reported Event|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255073|NCT01019135|E1|Reported Event|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
255074|NCT01018992|B3|Baseline|Total|Total of all reporting groups
255075|NCT01018992|B2|Baseline|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255076|NCT01018992|B1|Baseline|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255077|NCT01018992|P2|Participant Flow|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255078|NCT01018992|P1|Participant Flow|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255079|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255080|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255081|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255082|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255083|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255084|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255085|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255086|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255087|NCT01018992|E2|Reported Event|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
255088|NCT01018992|E1|Reported Event|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
255089|NCT01018979|B3|Baseline|Total|Total of all reporting groups
255090|NCT01018979|B2|Baseline|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255091|NCT01018979|B1|Baseline|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255092|NCT01018979|P2|Participant Flow|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255093|NCT01018979|P1|Participant Flow|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255094|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
255095|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
255096|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
255097|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255098|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255099|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255100|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255101|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255102|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255103|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255104|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255105|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255106|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255107|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255108|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255109|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255110|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255111|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255112|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255114|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
255115|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
255116|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255117|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255118|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255119|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255120|NCT01018979|E2|Reported Event|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255121|NCT01018979|E1|Reported Event|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
255122|NCT01018953|B1|Baseline|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
255123|NCT01018953|P1|Participant Flow|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
255124|NCT01018953|O1|Outcome|BIM 23A760|
255125|NCT01018953|O1|Outcome|BIM 23A760|
255126|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
255127|NCT01018953|O1|Outcome|BIM 23A760|
255128|NCT01018953|O1|Outcome|BIM 23A760|
255129|NCT01018953|O1|Outcome|BIM 23A760|
255130|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
255131|NCT01018953|E1|Reported Event|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
255132|NCT01018862|B4|Baseline|Total|Total of all reporting groups
255133|NCT01018862|B3|Baseline|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255134|NCT01018862|B2|Baseline|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255135|NCT01018862|B1|Baseline|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255136|NCT01018862|P3|Participant Flow|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255137|NCT01018862|P2|Participant Flow|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255138|NCT01018862|P1|Participant Flow|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255139|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255140|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255141|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255142|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255143|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255144|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255145|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255146|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255147|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255148|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255149|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255150|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255151|NCT01018862|E3|Reported Event|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255152|NCT01018862|E2|Reported Event|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255153|NCT01018862|E1|Reported Event|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
255154|NCT01018810|B6|Baseline|Total|Total of all reporting groups
255155|NCT01018810|B5|Baseline|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255156|NCT01018810|B4|Baseline|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255157|NCT01018810|B3|Baseline|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255158|NCT01018810|B2|Baseline|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255159|NCT01018810|B1|Baseline|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255160|NCT01018810|P5|Participant Flow|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255161|NCT01018810|P4|Participant Flow|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255162|NCT01018810|P3|Participant Flow|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255163|NCT01018810|P2|Participant Flow|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255164|NCT01018810|P1|Participant Flow|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255165|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255166|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255167|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255168|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255169|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255170|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255171|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255172|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255173|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255174|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255175|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255176|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255177|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255178|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255179|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255180|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255181|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255182|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255183|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255184|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255185|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255186|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255187|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255188|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255189|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255190|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255191|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255192|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255193|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255194|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255195|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255196|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255197|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255198|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255199|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255200|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255201|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255202|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255203|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255204|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255205|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255206|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255207|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255208|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255209|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255210|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255211|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255212|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
255213|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
255214|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
255215|NCT01018810|E5|Reported Event|90 mg LY2525623|
255216|NCT01018810|E4|Reported Event|30 mg LY2525623|
255217|NCT01018810|E3|Reported Event|3 mg LY2525623|
255218|NCT01018810|E2|Reported Event|Subcutaneous Placebo|
255219|NCT01018810|E1|Reported Event|180 mg LY2525623|
255220|NCT01018732|B4|Baseline|Total|Total of all reporting groups
255221|NCT01018732|B3|Baseline|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
255222|NCT01018732|B2|Baseline|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
255223|NCT01018732|B1|Baseline|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
255224|NCT01018732|P3|Participant Flow|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
255225|NCT01018732|P2|Participant Flow|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
255226|NCT01018732|P1|Participant Flow|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
255227|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255228|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255229|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255230|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255231|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255232|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255233|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255234|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255235|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255236|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255237|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255238|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255239|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255240|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255241|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255242|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255243|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255244|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255245|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255246|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255247|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255248|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255249|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255250|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255251|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
255252|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255253|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
255254|NCT01018732|E3|Reported Event|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
255255|NCT01018732|E2|Reported Event|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
255256|NCT01018732|E1|Reported Event|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
255257|NCT01018680|B3|Baseline|Total|Total of all reporting groups
255258|NCT01018680|B2|Baseline|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255259|NCT01018680|B1|Baseline|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255260|NCT01018680|P2|Participant Flow|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255261|NCT01018680|P1|Participant Flow|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255262|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255263|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255264|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255265|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255266|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255267|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255765|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
256731|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
255268|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255269|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255270|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255271|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255272|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255273|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255274|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255275|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255276|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255277|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255278|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255279|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255280|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255281|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255282|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255283|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255284|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255285|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255286|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255287|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255288|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255289|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255290|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255291|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255292|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255293|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255294|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255295|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255296|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255297|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
256732|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
255298|NCT01018680|E2|Reported Event|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
255299|NCT01018680|E1|Reported Event|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
255300|NCT01018511|B5|Baseline|Total|Total of all reporting groups
255301|NCT01018511|B4|Baseline|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255302|NCT01018511|B3|Baseline|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255303|NCT01018511|B2|Baseline|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255304|NCT01018511|B1|Baseline|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255305|NCT01018511|P4|Participant Flow|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255306|NCT01018511|P3|Participant Flow|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255307|NCT01018511|P2|Participant Flow|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255308|NCT01018511|P1|Participant Flow|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255309|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255310|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255311|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255312|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255313|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255314|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255315|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255316|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255317|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255318|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255319|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255320|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255321|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255322|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255664|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255323|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255324|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255325|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255326|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255327|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255328|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255329|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255330|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255331|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255332|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255333|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255334|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255335|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255336|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255337|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255338|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255339|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255340|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255341|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255342|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255343|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255344|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255345|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255346|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
256733|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
256734|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
255347|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255348|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255349|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255350|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255351|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255352|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255353|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255354|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255355|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255356|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255357|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255358|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255359|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255360|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255361|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255362|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255363|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255364|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255365|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255366|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255367|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255368|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255369|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255665|NCT01018134|E6|Reported Event|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255370|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255371|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255372|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255373|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255374|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255375|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255376|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255377|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255378|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255379|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255380|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255381|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255382|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255383|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255384|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255385|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255386|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255387|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255388|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255389|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255390|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255391|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255392|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255416|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255393|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255394|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255395|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255396|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255397|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255398|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255399|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255400|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255401|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255402|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255403|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255404|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255405|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255406|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255407|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255408|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255409|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255410|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255411|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255412|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255413|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255414|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255415|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255661|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255417|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255418|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255419|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255420|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255421|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255422|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255423|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255424|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255425|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255426|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255427|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255428|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255429|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255430|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255431|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255432|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255433|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255434|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255435|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255436|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255437|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255438|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255439|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255662|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255440|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255441|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255442|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255443|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255444|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255445|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255446|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255447|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255448|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255449|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255450|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255451|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255452|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255453|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255454|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255455|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255456|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255457|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255458|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255459|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255460|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255461|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255462|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255666|NCT01018134|E5|Reported Event|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255463|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255464|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255465|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255466|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255467|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255468|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255469|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255470|NCT01018511|E4|Reported Event|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255471|NCT01018511|E3|Reported Event|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255472|NCT01018511|E2|Reported Event|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255473|NCT01018511|E1|Reported Event|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
255474|NCT01018420|B3|Baseline|Total|Total of all reporting groups
255475|NCT01018420|B2|Baseline|Moxifloxacin|400 mg capsule at the 6 hour point
255476|NCT01018420|B1|Baseline|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255477|NCT01018420|P2|Participant Flow|Moxifloxacin|400 mg capsule at the 6 hour point
255478|NCT01018420|P1|Participant Flow|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255479|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after moxifloxacin dose
255480|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after moxifloxacin dose
255481|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after moxifloxacin dose
255482|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after moxifloxacin dose
255483|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after moxifloxacin dose
255484|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after moxifloxacin dose
255485|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after moxifloxacin dose
255486|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after moxifloxacin dose
255487|NCT01018420|O1|Outcome|Baseline|measured 0.5 hour prior to moxifloxacin dose
255488|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after initial colchicine dose
255489|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after initial colchicine dose
255490|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after initial colchicine dose
255491|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after initial colchicine dose
255492|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after initial colchicine dose
255493|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after initial colchicine dose
255494|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after initial colchicine dose
255495|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after initial colchicine dose
255496|NCT01018420|O1|Outcome|Baseline|measured 0.5 hr prior to initial colchicine dose
255497|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255498|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255499|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255500|NCT01018420|E2|Reported Event|Moxifloxacin|400 mg capsule at the 6 hour point
255501|NCT01018420|E1|Reported Event|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
255502|NCT01018394|B3|Baseline|Total|Total of all reporting groups
255503|NCT01018394|B2|Baseline|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
255663|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255504|NCT01018394|B1|Baseline|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
255505|NCT01018394|P2|Participant Flow|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
255506|NCT01018394|P1|Participant Flow|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
255507|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
255508|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
255509|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
255510|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
255511|NCT01018394|E2|Reported Event|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
255512|NCT01018394|E1|Reported Event|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
255513|NCT01018264|B3|Baseline|Total|Total of all reporting groups
255514|NCT01018264|B2|Baseline|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255515|NCT01018264|B1|Baseline|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255516|NCT01018264|P2|Participant Flow|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255517|NCT01018264|P1|Participant Flow|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255518|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255519|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255520|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255521|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255522|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255523|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255524|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255525|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255526|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255527|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255528|NCT01018264|E2|Reported Event|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
255529|NCT01018264|E1|Reported Event|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
255530|NCT01018186|B4|Baseline|Total|Total of all reporting groups
255531|NCT01018186|B3|Baseline|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255532|NCT01018186|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255533|NCT01018186|B1|Baseline|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255534|NCT01018186|P4|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255535|NCT01018186|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255536|NCT01018186|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255750|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
256735|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
255537|NCT01018186|P1|Participant Flow|Current Asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) with or without an additional controller medication (i.e., long-acting beta-agonist, leukotriene modifier, etc.) for 2 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
255538|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255539|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255540|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255541|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255542|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255543|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255544|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255545|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255546|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255547|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255548|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255549|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255550|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255551|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255552|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255553|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255554|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255555|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255556|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255557|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255558|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255559|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
256736|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
255560|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255561|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255562|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255563|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255564|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255565|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255566|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255567|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255568|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255569|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255570|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255571|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255572|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255573|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255574|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255575|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255576|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255577|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255578|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255579|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255580|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255581|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255582|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255751|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255583|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255584|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255585|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255586|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255587|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255588|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255589|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albutero/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255590|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participnts were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255591|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255592|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255593|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255594|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255595|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255596|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255597|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255598|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255599|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255600|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255601|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255602|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255603|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255604|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255605|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255752|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
256737|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
255606|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255607|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255608|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255609|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255610|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255611|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255612|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255613|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255614|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255615|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255616|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255617|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255618|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255619|NCT01018186|E3|Reported Event|FP 500 µg BD|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255620|NCT01018186|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255621|NCT01018186|E1|Reported Event|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
255622|NCT01018134|B7|Baseline|Total|Total of all reporting groups
255623|NCT01018134|B6|Baseline|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255624|NCT01018134|B5|Baseline|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255625|NCT01018134|B4|Baseline|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255626|NCT01018134|B3|Baseline|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255627|NCT01018134|B2|Baseline|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255628|NCT01018134|B1|Baseline|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255629|NCT01018134|P6|Participant Flow|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255630|NCT01018134|P5|Participant Flow|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255753|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255631|NCT01018134|P4|Participant Flow|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255632|NCT01018134|P3|Participant Flow|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255633|NCT01018134|P2|Participant Flow|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255634|NCT01018134|P1|Participant Flow|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255635|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255636|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255637|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255638|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255639|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255640|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255641|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255642|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255643|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255644|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255645|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255646|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255647|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255648|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255649|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255650|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255651|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255652|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255653|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255654|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255655|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255656|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255657|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255658|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255659|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
255660|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
255667|NCT01018134|E4|Reported Event|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
255668|NCT01018134|E3|Reported Event|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
255669|NCT01018134|E2|Reported Event|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
255670|NCT01018134|E1|Reported Event|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
255671|NCT01018095|B3|Baseline|Total|Total of all reporting groups
255672|NCT01018095|B2|Baseline|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255673|NCT01018095|B1|Baseline|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255674|NCT01018095|P2|Participant Flow|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255675|NCT01018095|P1|Participant Flow|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255676|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255677|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255678|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255679|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255680|NCT01018095|E2|Reported Event|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255681|NCT01018095|E1|Reported Event|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
255682|NCT01018056|B4|Baseline|Total|Total of all reporting groups
255683|NCT01018056|B3|Baseline|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255684|NCT01018056|B2|Baseline|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255685|NCT01018056|B1|Baseline|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255686|NCT01018056|P3|Participant Flow|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255687|NCT01018056|P2|Participant Flow|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255688|NCT01018056|P1|Participant Flow|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255754|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255689|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4."
255690|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255691|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255692|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3."
255693|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255694|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255695|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4."
255696|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255755|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255756|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255757|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255758|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255759|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
256738|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
255697|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255698|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255699|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255700|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255701|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255702|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255703|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255704|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255705|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255760|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255761|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255706|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255707|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255708|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255709|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255710|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255711|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255712|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255713|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255714|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255762|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255763|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255715|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255716|NCT01018056|E3|Reported Event|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
255717|NCT01018056|E2|Reported Event|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
255718|NCT01018056|E1|Reported Event|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
255719|NCT01018030|B4|Baseline|Total|Total of all reporting groups
255720|NCT01018030|B3|Baseline|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255721|NCT01018030|B2|Baseline|FFNS 110 Mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255722|NCT01018030|B1|Baseline|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
255723|NCT01018030|P3|Participant Flow|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255724|NCT01018030|P2|Participant Flow|FFNS 110 Mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255725|NCT01018030|P1|Participant Flow|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
255726|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255727|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255728|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255729|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255730|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255731|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255732|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255733|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255734|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255735|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255736|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255737|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255738|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255739|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255740|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255741|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255742|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255743|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255744|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255745|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255746|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255747|NCT01018030|O3|Outcome|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255748|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255749|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
255766|NCT01018030|O2|Outcome|FFNS 110 Mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255767|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
255768|NCT01018030|E3|Reported Event|FFNS 110 Mcg BD|FFNS 110 mcg administered BD for 14 days
255769|NCT01018030|E2|Reported Event|FFNS 110 Mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
255770|NCT01018030|E1|Reported Event|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
255771|NCT01017952|B5|Baseline|Total|Total of all reporting groups
255772|NCT01017952|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255773|NCT01017952|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255774|NCT01017952|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255775|NCT01017952|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255776|NCT01017952|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255777|NCT01017952|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255778|NCT01017952|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255779|NCT01017952|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255780|NCT01017952|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
255781|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255782|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255783|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255784|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255785|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255786|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255787|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255788|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255789|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255790|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255791|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255792|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255793|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255794|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255795|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255796|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255797|NCT01017952|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255798|NCT01017952|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255799|NCT01017952|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255800|NCT01017952|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
255801|NCT01017874|B3|Baseline|Total|Total of all reporting groups
255802|NCT01017874|B2|Baseline|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255803|NCT01017874|B1|Baseline|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255804|NCT01017874|P2|Participant Flow|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255805|NCT01017874|P1|Participant Flow|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255806|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255807|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255808|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255809|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255810|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255811|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255812|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255813|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255814|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255815|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255816|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255817|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255818|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255819|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255820|NCT01017874|E2|Reported Event|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
255821|NCT01017874|E1|Reported Event|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
255822|NCT01017731|B1|Baseline|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255823|NCT01017731|P1|Participant Flow|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255824|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255825|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously over 1 hour, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: 25 to 50 milligrams (mg) administered intravenously 1 day before each administration of ramucirumab for Cycles 1 to 4. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255826|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255846|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255907|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255827|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255828|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255829|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255830|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255831|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255832|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255833|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255834|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255847|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255835|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255836|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255837|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255838|NCT01017731|E1|Reported Event|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
255839|NCT01017653|B1|Baseline|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255840|NCT01017653|P1|Participant Flow|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255841|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255842|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255843|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255844|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255845|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255905|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255848|NCT01017653|E1|Reported Event|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
255849|NCT01017575|B6|Baseline|Total|Total of all reporting groups
255850|NCT01017575|B5|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255851|NCT01017575|B4|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255852|NCT01017575|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255853|NCT01017575|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255854|NCT01017575|B1|Baseline|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255855|NCT01017575|P5|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255856|NCT01017575|P4|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255857|NCT01017575|P3|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255858|NCT01017575|P2|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255859|NCT01017575|P1|Participant Flow|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255860|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255861|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255862|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255863|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255864|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255865|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255906|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
255908|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
255866|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255867|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255868|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255869|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255870|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255871|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255872|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255873|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255874|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255875|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255876|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255877|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255878|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255879|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255880|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255881|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255882|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255883|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255945|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255884|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255885|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255886|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255887|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255888|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
255889|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
255890|NCT01017575|E5|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255891|NCT01017575|E4|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
255892|NCT01017575|E3|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
255893|NCT01017575|E2|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
255894|NCT01017575|E1|Reported Event|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
255895|NCT01017549|B1|Baseline|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
255896|NCT01017549|P1|Participant Flow|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
255897|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
255898|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
255899|NCT01017549|E1|Reported Event|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
255900|NCT01017536|B3|Baseline|Total|Total of all reporting groups
255901|NCT01017536|B2|Baseline|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255902|NCT01017536|B1|Baseline|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
255903|NCT01017536|P2|Participant Flow|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255904|NCT01017536|P1|Participant Flow|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
256507|NCT01015677|B3|Baseline|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
255909|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255910|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
255911|NCT01017536|E2|Reported Event|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
255912|NCT01017536|E1|Reported Event|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
255913|NCT01017497|B1|Baseline|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255914|NCT01017497|P1|Participant Flow|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255915|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255916|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255917|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255918|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255919|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255920|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255921|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
255922|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
255923|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
255924|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
255925|NCT01017497|E1|Reported Event|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
255926|NCT01017263|B1|Baseline|Open Label Vyvanse|All subjects receive Vyvanse.
255927|NCT01017263|P1|Participant Flow|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
255928|NCT01017263|O1|Outcome|Vyvanse Open Label|Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
255929|NCT01017263|E1|Reported Event|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
255930|NCT01017250|B1|Baseline|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255931|NCT01017250|P1|Participant Flow|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255932|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255933|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255934|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255935|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255936|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255937|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255938|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255939|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
255940|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255941|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255942|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255943|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255944|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
256739|NCT01014624|O2|Outcome|Clopidogrel|Clopidogrel 75 mg tablet daily
255946|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255947|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255948|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255949|NCT01017250|E1|Reported Event|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
255950|NCT01017237|B3|Baseline|Total|Total of all reporting groups
255951|NCT01017237|B2|Baseline|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255952|NCT01017237|B1|Baseline|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255953|NCT01017237|P2|Participant Flow|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255954|NCT01017237|P1|Participant Flow|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255955|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255956|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255957|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255958|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255959|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255960|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255961|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255962|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255992|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255963|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255964|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255965|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255966|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255967|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255968|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255969|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255970|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255971|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255972|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255973|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255974|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255975|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255976|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255977|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255978|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
256009|NCT01017146|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
255979|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255980|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255981|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255982|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255983|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255984|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255985|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255986|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255987|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255988|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255989|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255990|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255991|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
256740|NCT01014624|O1|Outcome|Prasugrel|Prasugrel 10 mg tablet daily
255993|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255994|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255995|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255996|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
255997|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
255998|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
255999|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
256000|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
256001|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
256002|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
256003|NCT01017237|E2|Reported Event|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
256004|NCT01017237|E1|Reported Event|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
256005|NCT01017146|B3|Baseline|Total|Total of all reporting groups
256006|NCT01017146|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256007|NCT01017146|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256008|NCT01017146|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256741|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
256010|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256011|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256012|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256013|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256014|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256015|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256016|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256017|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256018|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256019|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256020|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256021|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256022|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256023|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256024|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256025|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256026|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256159|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256027|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256028|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256029|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256030|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256031|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256032|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256033|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256034|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256035|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256036|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256037|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256038|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256039|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256040|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256041|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256042|NCT01017146|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256043|NCT01017146|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256044|NCT01017120|B3|Baseline|Total|Total of all reporting groups
256742|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
256045|NCT01017120|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256046|NCT01017120|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256047|NCT01017120|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256048|NCT01017120|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256049|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256050|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256051|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256052|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256053|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256054|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256055|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256056|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256057|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256058|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256059|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256060|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256061|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256160|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256062|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256063|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256064|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256065|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256066|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256067|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256068|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256069|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256070|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256071|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256072|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256073|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256074|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256075|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256076|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256077|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256078|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256161|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256079|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256080|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256081|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256082|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256083|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256084|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256085|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256086|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256087|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256088|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256089|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256090|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256091|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256092|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256093|NCT01017120|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256094|NCT01017120|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
256095|NCT01017042|B1|Baseline|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256162|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256096|NCT01017042|P1|Participant Flow|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256097|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256098|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256099|NCT01017042|O5|Outcome|Corrected QTc Interval (4 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (4 hour)
256100|NCT01017042|O4|Outcome|Corrected QTc Interval (2 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (2 hour)
256101|NCT01017042|O3|Outcome|Corrected QTc Interval (1 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (1 hour)
256102|NCT01017042|O2|Outcome|Corrected QTc Interval (0.5 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (0.5hour)
256103|NCT01017042|O1|Outcome|Corrected QTc Interval (Baseline)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (Baseline)
256104|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256105|NCT01017042|E1|Reported Event|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
256106|NCT01017029|B3|Baseline|Total|Total of all reporting groups
256107|NCT01017029|B2|Baseline|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256108|NCT01017029|B1|Baseline|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256109|NCT01017029|P2|Participant Flow|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256110|NCT01017029|P1|Participant Flow|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256111|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256112|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256113|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256114|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256115|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256116|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256117|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256118|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256119|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256120|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256121|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256122|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256123|NCT01017029|E2|Reported Event|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
256124|NCT01017029|E1|Reported Event|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
256743|NCT01014624|O2|Outcome|Clopidogrel 75 mg Daily|
256125|NCT01017003|B1|Baseline|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
256126|NCT01017003|P1|Participant Flow|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
256127|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
256128|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
256129|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
256130|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
256131|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
256132|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
256133|NCT01017003|E2|Reported Event|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
256134|NCT01017003|E1|Reported Event|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
256135|NCT01016977|B3|Baseline|Total|Total of all reporting groups
256136|NCT01016977|B2|Baseline|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256137|NCT01016977|B1|Baseline|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
256138|NCT01016977|P2|Participant Flow|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256139|NCT01016977|P1|Participant Flow|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
256140|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256141|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256142|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256143|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256144|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256145|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256146|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256147|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256148|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256149|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256150|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256151|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256152|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256153|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256154|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256155|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256156|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256157|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256158|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256744|NCT01014624|O1|Outcome|Prasugrel 10 mg Daily|
256163|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256164|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256165|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256166|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256167|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
256168|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256169|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
256170|NCT01016977|E2|Reported Event|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
256171|NCT01016977|E1|Reported Event|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
256172|NCT01016964|B3|Baseline|Total|Total of all reporting groups
256173|NCT01016964|B2|Baseline|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
256174|NCT01016964|B1|Baseline|Sham Device|Sham device
256175|NCT01016964|P2|Participant Flow|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
256176|NCT01016964|P1|Participant Flow|Sham Device|Sham device
256177|NCT01016964|O2|Outcome|LLT Device 2009 12 Beams|This is the active LLLT device
256178|NCT01016964|O1|Outcome|Sham Device|This control device emits white light
256179|NCT01016964|E2|Reported Event|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
256180|NCT01016964|E1|Reported Event|Sham Device|Sham device
256181|NCT01016938|B1|Baseline|Dynmaic Lung MRI|Lung Tumor Motion and Function
256182|NCT01016938|P1|Participant Flow|Dynamic Lung MRI|Lung Tumor Motion and Function
256183|NCT01016938|O1|Outcome|Dynamic Lung MRI|Lung Tumor Motion and Function
256184|NCT01016938|O1|Outcome|Lung Tumor Motion and Lung Function|This is a pilot study and there is only one group.
256185|NCT01016938|E1|Reported Event|Dynamic Lung MRI|Lung Tumor Motion and Function
256186|NCT01016912|B6|Baseline|Total|Total of all reporting groups
256187|NCT01016912|B5|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256188|NCT01016912|B4|Baseline|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256189|NCT01016912|B3|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256190|NCT01016912|B2|Baseline|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256191|NCT01016912|B1|Baseline|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256192|NCT01016912|P5|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256193|NCT01016912|P4|Participant Flow|Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256194|NCT01016912|P3|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256195|NCT01016912|P2|Participant Flow|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256196|NCT01016912|P1|Participant Flow|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256197|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256198|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256199|NCT01016912|O3|Outcome|Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)|received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256200|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
256201|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
256202|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
256203|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256204|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256205|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256206|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256207|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256208|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256209|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256210|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256211|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256212|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256213|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
256214|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256215|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256745|NCT01014624|E2|Reported Event|Clopidogrel 75mg/ Daily|
256216|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
256217|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256218|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegINFα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256219|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256220|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
256221|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256222|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256223|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
256224|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256225|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
256226|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
256227|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256228|NCT01016912|O4|Outcome|Daclatasvir 10­ mg+ pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
256229|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
256230|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256231|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
256232|NCT01016912|E5|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
256233|NCT01016912|E4|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
256279|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256508|NCT01015677|B2|Baseline|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256234|NCT01016912|E3|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
256235|NCT01016912|E2|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
256236|NCT01016912|E1|Reported Event|Placebo+pegIFNα +Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
256237|NCT01016873|B4|Baseline|Total|Total of all reporting groups
256238|NCT01016873|B3|Baseline|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256239|NCT01016873|B2|Baseline|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256240|NCT01016873|B1|Baseline|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256241|NCT01016873|P3|Participant Flow|Sham IRay|"Sham 24 or 16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256242|NCT01016873|P2|Participant Flow|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256243|NCT01016873|P1|Participant Flow|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256244|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256245|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256246|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256247|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256248|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256249|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256250|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256251|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256252|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256253|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256254|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256255|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256256|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256257|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256258|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256259|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256260|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256261|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256262|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256263|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256264|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256265|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256266|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256267|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256268|NCT01016873|E3|Reported Event|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256269|NCT01016873|E2|Reported Event|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256270|NCT01016873|E1|Reported Event|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
256271|NCT01016847|B3|Baseline|Total|Total of all reporting groups
256272|NCT01016847|B2|Baseline|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256273|NCT01016847|B1|Baseline|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256274|NCT01016847|P2|Participant Flow|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256275|NCT01016847|P1|Participant Flow|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256276|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256277|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256278|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256746|NCT01014624|E1|Reported Event|Prasugrel 10 mg/Daily|
256280|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256281|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256282|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256283|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256284|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256285|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256286|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256287|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256288|NCT01016847|E2|Reported Event|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
256289|NCT01016847|E1|Reported Event|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
256290|NCT01016834|B1|Baseline|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256291|NCT01016834|P1|Participant Flow|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256292|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256293|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256294|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256295|NCT01016834|E1|Reported Event|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
256296|NCT01016691|B4|Baseline|Total|Total of all reporting groups
256297|NCT01016691|B3|Baseline|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
256298|NCT01016691|B2|Baseline|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
256299|NCT01016691|B1|Baseline|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
256300|NCT01016691|P3|Participant Flow|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
256301|NCT01016691|P2|Participant Flow|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
256302|NCT01016691|P1|Participant Flow|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
256303|NCT01016691|O3|Outcome|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
256304|NCT01016691|O2|Outcome|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
256305|NCT01016691|O1|Outcome|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
256306|NCT01016691|E3|Reported Event|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
256307|NCT01016691|E2|Reported Event|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
256308|NCT01016691|E1|Reported Event|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
256309|NCT01016678|B1|Baseline|Adolescents Age 12-17|All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
256310|NCT01016678|P5|Participant Flow|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
256311|NCT01016678|P4|Participant Flow|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
256332|NCT01016678|E1|Reported Event|Active, Active, Active, Placebo|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
256333|NCT01016652|B3|Baseline|Total|Total of all reporting groups
256312|NCT01016678|P3|Participant Flow|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
256313|NCT01016678|P2|Participant Flow|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
256314|NCT01016678|P1|Participant Flow|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
256315|NCT01016678|O5|Outcome|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
256316|NCT01016678|O4|Outcome|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
256317|NCT01016678|O3|Outcome|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
256318|NCT01016678|O2|Outcome|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
256319|NCT01016678|O1|Outcome|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
256320|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
256321|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
256322|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
256323|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
256324|NCT01016678|O4|Outcome|Migraine Attack 4|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
256325|NCT01016678|O3|Outcome|Migraine Attack 3|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
256326|NCT01016678|O2|Outcome|Migraine Attack 2|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
256327|NCT01016678|O1|Outcome|Migraine Attack 1|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
256328|NCT01016678|E5|Reported Event|Active, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
256329|NCT01016678|E4|Reported Event|Placebo, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
256330|NCT01016678|E3|Reported Event|Active, Placebo, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
256331|NCT01016678|E2|Reported Event|Active, Active, Placebo, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
256334|NCT01016652|B2|Baseline|Etafilcon A Sphere\ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
256335|NCT01016652|B1|Baseline|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
256336|NCT01016652|P2|Participant Flow|Etafilcon A Sphere/ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
256337|NCT01016652|P1|Participant Flow|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
256338|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
256339|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
256340|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
256341|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
256342|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
256343|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
256344|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
256345|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
256346|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
256347|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
256348|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere worn
256349|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal worn.
256350|NCT01016652|E2|Reported Event|Etafilcon A Sphere|etafilcon A sphere worn
256351|NCT01016652|E1|Reported Event|Etafilcon A Multifocal|etafilcon A multifocal worn
256352|NCT01016600|B5|Baseline|Total|Total of all reporting groups
256353|NCT01016600|B4|Baseline|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256354|NCT01016600|B3|Baseline|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256355|NCT01016600|B2|Baseline|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256356|NCT01016600|B1|Baseline|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256357|NCT01016600|P4|Participant Flow|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256358|NCT01016600|P3|Participant Flow|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256359|NCT01016600|P2|Participant Flow|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256360|NCT01016600|P1|Participant Flow|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256361|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256362|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256363|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256364|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256365|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256366|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256367|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256368|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256369|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256509|NCT01015677|B1|Baseline|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256370|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256371|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256372|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256373|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256374|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256375|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256376|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256377|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256378|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256379|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256380|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256381|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256382|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256383|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256384|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256385|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256386|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256387|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256388|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256389|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256390|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256391|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256392|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256393|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256394|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256395|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256396|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256397|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256398|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256747|NCT01014585|B5|Baseline|Total|Total of all reporting groups
256399|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256400|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256401|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256402|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256403|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256404|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256405|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256406|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256407|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256408|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256409|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256410|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256411|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256412|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256413|NCT01016600|O1|Outcome|Phase I Cohort|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256414|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256415|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256416|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256417|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256418|NCT01016600|E4|Reported Event|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256419|NCT01016600|E3|Reported Event|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256420|NCT01016600|E2|Reported Event|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256421|NCT01016600|E1|Reported Event|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
256422|NCT01016132|B1|Baseline|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
256423|NCT01016132|P1|Participant Flow|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
256424|NCT01016132|O1|Outcome|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
256466|NCT01015820|B2|Baseline|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
257638|NCT01011868|O1|Outcome|Placebo|Oral Placebo
256425|NCT01016132|E1|Reported Event|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
256426|NCT01016106|B3|Baseline|Total|Total of all reporting groups
256427|NCT01016106|B2|Baseline|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
256428|NCT01016106|B1|Baseline|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
256429|NCT01016106|P2|Participant Flow|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
256430|NCT01016106|P1|Participant Flow|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
256431|NCT01016106|O2|Outcome|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
256432|NCT01016106|O1|Outcome|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
256433|NCT01016106|E2|Reported Event|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
256434|NCT01016106|E1|Reported Event|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
256435|NCT01016067|B3|Baseline|Total|Total of all reporting groups
256436|NCT01016067|B2|Baseline|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256437|NCT01016067|B1|Baseline|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256438|NCT01016067|P2|Participant Flow|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256439|NCT01016067|P1|Participant Flow|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256440|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256441|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256442|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256443|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256444|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256445|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256446|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256447|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256448|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256449|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256450|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256451|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256452|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256453|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256454|NCT01016067|E2|Reported Event|Autograft Bone|Patients received autograft bone with rigid internal fixation.
256455|NCT01016067|E1|Reported Event|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
256456|NCT01016015|B1|Baseline|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
256457|NCT01016015|P1|Participant Flow|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
256458|NCT01016015|O1|Outcome|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
256459|NCT01016015|E1|Reported Event|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
256460|NCT01015976|B1|Baseline|Active Drug|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
256461|NCT01015976|P2|Participant Flow|Control Group|"active drug~No surgery matched subjects"
256462|NCT01015976|P1|Participant Flow|Experimental|Post surgery group Sertraline : Single dose of 100mg sertraline
256463|NCT01015976|O1|Outcome|Control|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
256464|NCT01015976|E1|Reported Event|Active Drug|"Two arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
256465|NCT01015820|B3|Baseline|Total|Total of all reporting groups
256498|NCT01015703|O3|Outcome|5 mg Dose|5 mg CoVaccine HT
256499|NCT01015703|O2|Outcome|2 mg Dose|2 mg CoVaccine HT
256467|NCT01015820|B1|Baseline|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256468|NCT01015820|P2|Participant Flow|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256469|NCT01015820|P1|Participant Flow|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
256470|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256471|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256472|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256473|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256474|NCT01015820|E2|Reported Event|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256475|NCT01015820|E1|Reported Event|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
256476|NCT01015781|B3|Baseline|Total|Total of all reporting groups
256477|NCT01015781|B2|Baseline|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
256478|NCT01015781|B1|Baseline|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
256479|NCT01015781|P2|Participant Flow|Wait List Control|Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
256480|NCT01015781|P1|Participant Flow|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
256481|NCT01015781|O2|Outcome|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
256482|NCT01015781|O1|Outcome|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
256483|NCT01015781|E2|Reported Event|Wait List Control|Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
256484|NCT01015781|E1|Reported Event|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
256485|NCT01015703|B6|Baseline|Total|Total of all reporting groups
256486|NCT01015703|B5|Baseline|10 mg Dose|10 mg CoVaccine HT
256487|NCT01015703|B4|Baseline|7 mg Dose|7 mg CoVaccine HT
256488|NCT01015703|B3|Baseline|5 mg Dose|5 mg CoVaccine HT
256489|NCT01015703|B2|Baseline|2 mg Dose|2 mg CoVaccine HT
256490|NCT01015703|B1|Baseline|1 mg Dose|1 mg CoVaccine HT
256491|NCT01015703|P5|Participant Flow|10 mg Dose|10 mg CoVaccine HT
256492|NCT01015703|P4|Participant Flow|7 mg Dose|7 mg CoVaccine HT
256493|NCT01015703|P3|Participant Flow|5 mg Dose|5 mg CoVaccine HT
256494|NCT01015703|P2|Participant Flow|2 mg Dose|2 mg CoVaccine HT
256495|NCT01015703|P1|Participant Flow|1 mg Dose|1 mg CoVaccine HT
256496|NCT01015703|O5|Outcome|10 mg Dose|10 mg CoVaccine HT
256497|NCT01015703|O4|Outcome|7 mg Dose|7 mg CoVaccine HT
256510|NCT01015677|P3|Participant Flow|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256511|NCT01015677|P2|Participant Flow|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256512|NCT01015677|P1|Participant Flow|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256513|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256514|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256515|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256516|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256517|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256518|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256519|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256520|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256521|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256522|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256523|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256524|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256525|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256526|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256527|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256528|NCT01015677|E3|Reported Event|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256529|NCT01015677|E2|Reported Event|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
256530|NCT01015677|E1|Reported Event|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
256531|NCT01015638|B3|Baseline|Total|Total of all reporting groups
256532|NCT01015638|B2|Baseline|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256533|NCT01015638|B1|Baseline|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256534|NCT01015638|P2|Participant Flow|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256535|NCT01015638|P1|Participant Flow|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256536|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256537|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256538|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256539|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256540|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256541|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256542|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256543|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256544|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256545|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256546|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256547|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256548|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256549|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256550|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256551|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256552|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256553|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256554|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256555|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256556|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256557|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256558|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256559|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256560|NCT01015638|E2|Reported Event|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
256561|NCT01015638|E1|Reported Event|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
256562|NCT01015560|B1|Baseline|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
256563|NCT01015560|P1|Participant Flow|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
256564|NCT01015560|O1|Outcome|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
256565|NCT01015560|E1|Reported Event|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
256566|NCT01015534|B3|Baseline|Total|Total of all reporting groups
256567|NCT01015534|B2|Baseline|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
256568|NCT01015534|B1|Baseline|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
256569|NCT01015534|P2|Participant Flow|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
256570|NCT01015534|P1|Participant Flow|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
256571|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
256572|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
256573|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
256574|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
256575|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
256576|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
256577|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
256578|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
256579|NCT01015534|E2|Reported Event|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
256580|NCT01015534|E1|Reported Event|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
256581|NCT01015443|B3|Baseline|Total|Total of all reporting groups
256582|NCT01015443|B2|Baseline|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256583|NCT01015443|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256631|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256632|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256584|NCT01015443|P2|Participant Flow|Saline + Placebo + BSC|A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256585|NCT01015443|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256586|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256587|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256588|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256589|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256590|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256591|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256592|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256593|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256594|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
257050|NCT01013844|E2|Reported Event|Dyadic Learning|Participant and partner learning together.
256595|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256596|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256597|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256598|NCT01015443|E2|Reported Event|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256599|NCT01015443|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
256600|NCT01015326|B3|Baseline|Total|Total of all reporting groups
256601|NCT01015326|B2|Baseline|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
256602|NCT01015326|B1|Baseline|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
256603|NCT01015326|P2|Participant Flow|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL).~Questionnaire : Administered questionnaire"
256604|NCT01015326|P1|Participant Flow|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
256605|NCT01015326|O2|Outcome|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
256606|NCT01015326|O1|Outcome|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
256633|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256634|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256607|NCT01015326|E2|Reported Event|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
256608|NCT01015326|E1|Reported Event|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
256609|NCT01015287|B3|Baseline|Total|Total of all reporting groups
256610|NCT01015287|B2|Baseline|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256611|NCT01015287|B1|Baseline|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256612|NCT01015287|P2|Participant Flow|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256613|NCT01015287|P1|Participant Flow|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256614|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256615|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256616|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256617|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256618|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256619|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256620|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256621|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256622|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256623|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256624|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256625|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256626|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256627|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256628|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256629|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256630|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256669|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256635|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256636|NCT01015287|E2|Reported Event|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256637|NCT01015287|E1|Reported Event|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
256638|NCT01015131|B1|Baseline|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256639|NCT01015131|P1|Participant Flow|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256640|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256641|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256642|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256643|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256644|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256645|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256646|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256647|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256648|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256649|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256650|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256651|NCT01015131|E1|Reported Event|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
256652|NCT01015118|B3|Baseline|Total|Total of all reporting groups
256653|NCT01015118|B2|Baseline|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256654|NCT01015118|B1|Baseline|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256655|NCT01015118|P2|Participant Flow|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256656|NCT01015118|P1|Participant Flow|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256657|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256658|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256659|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256660|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256661|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256662|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256663|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256664|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256665|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256666|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256667|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256668|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256724|NCT01014624|B3|Baseline|Total|Total of all reporting groups
256725|NCT01014624|B2|Baseline|Clopidogrel|Clopidogrel 75 mg tablet daily
256670|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256671|NCT01015118|E2|Reported Event|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256672|NCT01015118|E1|Reported Event|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
256673|NCT01014975|B1|Baseline|Safety Population|Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
256674|NCT01014975|P3|Participant Flow|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
256675|NCT01014975|P2|Participant Flow|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
256676|NCT01014975|P1|Participant Flow|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
256677|NCT01014975|O3|Outcome|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
256678|NCT01014975|O2|Outcome|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
256679|NCT01014975|O1|Outcome|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
256680|NCT01014975|E3|Reported Event|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
256681|NCT01014975|E2|Reported Event|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
256682|NCT01014975|E1|Reported Event|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
256683|NCT01014910|B3|Baseline|Total|Total of all reporting groups
256684|NCT01014910|B2|Baseline|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
256685|NCT01014910|B1|Baseline|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
256686|NCT01014910|P2|Participant Flow|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
256687|NCT01014910|P1|Participant Flow|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
256688|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
256689|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
256690|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
256726|NCT01014624|B1|Baseline|Prasugrel|Prasugrel 10 mg tablet daily
256691|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
256692|NCT01014910|E2|Reported Event|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
256693|NCT01014910|E1|Reported Event|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
256694|NCT01014871|B1|Baseline|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
256695|NCT01014871|P1|Participant Flow|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
256696|NCT01014871|O2|Outcome|Vistabel|"at Baseline:~- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
256697|NCT01014871|O1|Outcome|Azzalure|"at Baseline:~- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead"
256698|NCT01014871|E2|Reported Event|Vistabel|intra-individual comparison
256699|NCT01014871|E1|Reported Event|Azzalure|intra-individual comparison
256700|NCT01014728|B3|Baseline|Total|Total of all reporting groups
256701|NCT01014728|B2|Baseline|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256702|NCT01014728|B1|Baseline|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256703|NCT01014728|P2|Participant Flow|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256704|NCT01014728|P1|Participant Flow|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256705|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256706|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256707|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256708|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256709|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256710|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256711|NCT01014728|E2|Reported Event|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
256712|NCT01014728|E1|Reported Event|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
256713|NCT01014689|B3|Baseline|Total|Total of all reporting groups
256714|NCT01014689|B2|Baseline|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256715|NCT01014689|B1|Baseline|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256716|NCT01014689|P2|Participant Flow|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256717|NCT01014689|P1|Participant Flow|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256718|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256719|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256720|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256721|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256722|NCT01014689|E2|Reported Event|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256723|NCT01014689|E1|Reported Event|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
256748|NCT01014585|B4|Baseline|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."
256749|NCT01014585|B3|Baseline|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
256750|NCT01014585|B2|Baseline|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
256751|NCT01014585|B1|Baseline|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
256752|NCT01014585|P4|Participant Flow|Non-Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Non-Responders
256753|NCT01014585|P3|Participant Flow|Non-Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Non-Responders
256754|NCT01014585|P2|Participant Flow|Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Responders
256755|NCT01014585|P1|Participant Flow|Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Responders
256756|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
256757|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
256758|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
256759|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
256760|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
256761|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
256762|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
256763|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
256764|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
256765|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
256766|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
256767|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
256768|NCT01014585|E4|Reported Event|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population."
256769|NCT01014585|E3|Reported Event|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
256770|NCT01014585|E2|Reported Event|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
256771|NCT01014585|E1|Reported Event|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
256772|NCT01014455|B3|Baseline|Total|Total of all reporting groups
256773|NCT01014455|B2|Baseline|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
256774|NCT01014455|B1|Baseline|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
256775|NCT01014455|P2|Participant Flow|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
256776|NCT01014455|P1|Participant Flow|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
256777|NCT01014455|O2|Outcome|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
256778|NCT01014455|O1|Outcome|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
256779|NCT01014455|E2|Reported Event|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
256780|NCT01014455|E1|Reported Event|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
256781|NCT01014442|B3|Baseline|Total|Total of all reporting groups
260265|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
256782|NCT01014442|B2|Baseline|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256783|NCT01014442|B1|Baseline|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256784|NCT01014442|P2|Participant Flow|MMF - COPD, Emphysema, IPF, or A1AD|Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256785|NCT01014442|P1|Participant Flow|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256786|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256787|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256788|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256789|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256790|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256791|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256792|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256793|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256794|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256795|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256796|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256797|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256798|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256799|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256800|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256801|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256802|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256803|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256804|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256805|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256806|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256807|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
257051|NCT01013844|E1|Reported Event|Solo Learning|Participant learning alone (without partner).
256808|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256809|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256810|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256811|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256812|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256813|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256814|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256815|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256816|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256817|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256818|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256819|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256820|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256821|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256822|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256823|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256824|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256825|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256826|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256827|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256828|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256829|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256830|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256831|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256832|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256833|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
257052|NCT01013792|B3|Baseline|Total|Total of all reporting groups
256834|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256835|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256836|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256837|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256838|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256839|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256840|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256841|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256842|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256843|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256844|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256845|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256846|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256847|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256848|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256849|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256850|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256851|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256852|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256853|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256854|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256855|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256856|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256857|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256858|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256859|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
262565|NCT00997373|O2|Outcome|Control|no treatemtn prior to hysterectomy
256860|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256861|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256862|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256863|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256864|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256865|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256866|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256867|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256868|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256869|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256870|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256871|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256872|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256873|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256874|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256875|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256876|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256877|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256878|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256879|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256880|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256881|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256882|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256883|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256884|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256885|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256886|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256887|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256888|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256889|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256890|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256891|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256892|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256893|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256894|NCT01014442|E2|Reported Event|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
256895|NCT01014442|E1|Reported Event|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
256896|NCT01014351|B1|Baseline|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256897|NCT01014351|P1|Participant Flow|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256898|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256899|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256900|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256901|NCT01014351|E1|Reported Event|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
256902|NCT01014208|B3|Baseline|Total|Total of all reporting groups
256903|NCT01014208|B2|Baseline|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256904|NCT01014208|B1|Baseline|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256905|NCT01014208|P2|Participant Flow|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256906|NCT01014208|P1|Participant Flow|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256907|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256908|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256909|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256910|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256911|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256954|NCT01014143|E3|Reported Event|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
256955|NCT01014143|E2|Reported Event|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
256956|NCT01014143|E1|Reported Event|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
256957|NCT01014013|B3|Baseline|Total|Total of all reporting groups
256958|NCT01014013|B2|Baseline|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
256912|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256913|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256914|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256915|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256916|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256917|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256918|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256919|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256920|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256921|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256922|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256923|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256924|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256925|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256926|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256927|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256928|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256929|NCT01014208|E2|Reported Event|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256930|NCT01014208|E1|Reported Event|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
256931|NCT01014169|B3|Baseline|Total|Total of all reporting groups
256932|NCT01014169|B2|Baseline|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256933|NCT01014169|B1|Baseline|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256934|NCT01014169|P2|Participant Flow|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256935|NCT01014169|P1|Participant Flow|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256936|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256937|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256938|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256939|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256940|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256941|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256942|NCT01014169|E2|Reported Event|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
256943|NCT01014169|E1|Reported Event|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
256944|NCT01014143|B4|Baseline|Total|Total of all reporting groups
256945|NCT01014143|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
256946|NCT01014143|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
256947|NCT01014143|B1|Baseline|Fluoride Toothpaste|negative control
256948|NCT01014143|P3|Participant Flow|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
256949|NCT01014143|P2|Participant Flow|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
256950|NCT01014143|P1|Participant Flow|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
256951|NCT01014143|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
256952|NCT01014143|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
256953|NCT01014143|O1|Outcome|Fluoride Toothpaste|negative control
256959|NCT01014013|B1|Baseline|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
256960|NCT01014013|P2|Participant Flow|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
256961|NCT01014013|P1|Participant Flow|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
256962|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
256963|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
256964|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
256965|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
256966|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
256967|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
256968|NCT01014013|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
256969|NCT01014013|E1|Reported Event|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
256970|NCT01013961|B3|Baseline|Total|Total of all reporting groups
256971|NCT01013961|B2|Baseline|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256972|NCT01013961|B1|Baseline|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256973|NCT01013961|P2|Participant Flow|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256974|NCT01013961|P1|Participant Flow|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256975|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
257053|NCT01013792|B2|Baseline|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
263526|NCT00996736|O1|Outcome|Topical Natamycin|
256976|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256977|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256978|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256979|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256980|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256981|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256982|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256983|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256984|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256985|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256986|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
257013|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257054|NCT01013792|B1|Baseline|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
256987|NCT01013961|E2|Reported Event|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256988|NCT01013961|E1|Reported Event|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
256989|NCT01013883|B3|Baseline|Total|Total of all reporting groups
256990|NCT01013883|B2|Baseline|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
256991|NCT01013883|B1|Baseline|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
256992|NCT01013883|P2|Participant Flow|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
256993|NCT01013883|P1|Participant Flow|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
256994|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
256995|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
256996|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
256997|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
256998|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
256999|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
257000|NCT01013883|E2|Reported Event|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
257001|NCT01013883|E1|Reported Event|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
257002|NCT01013870|B3|Baseline|Total|Total of all reporting groups
257003|NCT01013870|B2|Baseline|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257004|NCT01013870|B1|Baseline|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257005|NCT01013870|P2|Participant Flow|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257006|NCT01013870|P1|Participant Flow|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257007|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257008|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257009|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257010|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257011|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257012|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257014|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257015|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257016|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257017|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257018|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257019|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257020|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257021|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257022|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257023|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257024|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257025|NCT01013870|E2|Reported Event|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
257026|NCT01013870|E1|Reported Event|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
257027|NCT01013844|B3|Baseline|Total|Total of all reporting groups
257028|NCT01013844|B2|Baseline|Dyadic Learning|Participant and partner learning together.
257029|NCT01013844|B1|Baseline|Solo Learning|Participant learning alone (without partner).
257030|NCT01013844|P2|Participant Flow|Dyadic Learning|Participant and partner learning together.
257031|NCT01013844|P1|Participant Flow|Solo Learning|Participant learning alone (without partner).
257032|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
257033|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
257034|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
257035|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
257036|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
257037|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
257038|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
257039|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
257040|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
257041|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
257042|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
257043|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
257044|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
257045|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
257046|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
257047|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
257048|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
257049|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
257055|NCT01013792|P2|Participant Flow|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
257056|NCT01013792|P1|Participant Flow|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
257057|NCT01013792|O2|Outcome|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
257058|NCT01013792|O1|Outcome|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
257059|NCT01013792|E2|Reported Event|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
257060|NCT01013792|E1|Reported Event|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
257061|NCT01013753|B1|Baseline|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
257062|NCT01013753|P1|Participant Flow|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
257063|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257064|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257065|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257066|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257067|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257068|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257069|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257070|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257071|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257072|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257073|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257074|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257075|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257076|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257077|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257078|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257079|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257080|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257081|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257082|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257083|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257084|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257085|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257086|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257087|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257088|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257089|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257090|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257091|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257092|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257093|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257094|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257095|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257096|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257097|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257639|NCT01011868|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257098|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257099|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257100|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257101|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257102|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257103|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257104|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257105|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257106|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257107|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257108|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257109|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257110|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257111|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257112|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257113|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257114|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257115|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257116|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257117|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257118|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257119|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257120|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257121|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257122|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257123|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257124|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257125|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257126|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257127|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257128|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257129|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257130|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257131|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257132|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257133|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257134|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257135|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257136|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257137|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257138|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257139|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257140|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257141|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257142|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257143|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257144|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257145|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257146|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257147|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
263527|NCT00996736|E2|Reported Event|Topical Voriconazole|
257148|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257149|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257150|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257151|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257152|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257153|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257154|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257155|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257156|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257157|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257158|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257159|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257160|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257161|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257162|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257163|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257164|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257165|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257166|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257167|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257168|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257169|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257170|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257171|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257172|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257173|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257174|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257175|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257176|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257177|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257178|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257179|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257180|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257181|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257182|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257183|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257184|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257185|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257186|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257187|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257188|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257189|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257190|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257191|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257192|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257193|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257194|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257195|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257196|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257197|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257198|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257199|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257200|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257201|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257202|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257203|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257204|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257205|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257206|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257207|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257208|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257209|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257210|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257211|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257212|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257213|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257214|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257215|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257216|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257217|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257218|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257219|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257220|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257221|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257222|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257223|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257224|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257225|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257226|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257227|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257228|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257229|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257230|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257231|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257232|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257233|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257234|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257235|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257236|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257237|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257238|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257239|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257240|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257241|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257242|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257243|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257244|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257245|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257246|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257247|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257248|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257249|NCT01013753|E6|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
257250|NCT01013753|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257251|NCT01013753|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257252|NCT01013753|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257253|NCT01013753|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
257254|NCT01013753|E1|Reported Event|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
257255|NCT01013740|B3|Baseline|Total|Total of all reporting groups
257256|NCT01013740|B2|Baseline|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
257257|NCT01013740|B1|Baseline|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
257258|NCT01013740|P2|Participant Flow|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
257259|NCT01013740|P1|Participant Flow|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
257260|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257261|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257262|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257263|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257264|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257265|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257266|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257267|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257268|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257269|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257270|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257271|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257272|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257273|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257274|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257275|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257276|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
257277|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
257278|NCT01013740|E4|Reported Event|Lapatinib Plus Vinorelbine in the CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
257279|NCT01013740|E3|Reported Event|Lapatinib Plus Capecitabine in the CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
257280|NCT01013740|E2|Reported Event|Lapatinib Plus Vinorelbine in the RP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
263528|NCT00996736|E1|Reported Event|Topical Natamycin|
257281|NCT01013740|E1|Reported Event|Lapatinib Plus Capecitabine in the RP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
257282|NCT01013597|B1|Baseline|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257283|NCT01013597|P1|Participant Flow|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257284|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257285|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257286|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257287|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257288|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257289|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257290|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257291|NCT01013597|E1|Reported Event|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
257292|NCT01013207|B1|Baseline|All Participants|
257293|NCT01013207|P1|Participant Flow|All Participants|
257294|NCT01013207|O1|Outcome|All Participants|
257295|NCT01013207|O1|Outcome|All Participants|
257296|NCT01013207|E1|Reported Event|All Participants|
257297|NCT01013194|B3|Baseline|Total|Total of all reporting groups
257298|NCT01013194|B2|Baseline|Control Patients|Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
257299|NCT01013194|B1|Baseline|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
257300|NCT01013194|P2|Participant Flow|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
257301|NCT01013194|P1|Participant Flow|Treated Patients|"Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.~Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.~Cell infusion: between 5x10^8 and 10x10^8 cells. Number of sessions: up to 2."
257302|NCT01013194|O2|Outcome|Control Patients|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
257303|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
257304|NCT01013194|O2|Outcome|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
257305|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
257306|NCT01013194|O2|Outcome|Control Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
257307|NCT01013194|O1|Outcome|Treated Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
257308|NCT01013194|E2|Reported Event|Control Group|Patients with end-stage chronic liver disease in waiting list for liver transplantation.
257309|NCT01013194|E1|Reported Event|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
257310|NCT01012973|B3|Baseline|Total|Total of all reporting groups
257311|NCT01012973|B2|Baseline|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257312|NCT01012973|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257313|NCT01012973|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257314|NCT01012973|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept Injection|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257315|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257582|NCT01011933|B1|Baseline|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257316|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257317|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257318|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257319|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257320|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257321|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257322|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257323|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257324|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257325|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
257326|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
257327|NCT01012973|E6|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 68)|Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
257328|NCT01012973|E5|Reported Event|Aflibercept Injection Continued (Until Week 68)|Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
257329|NCT01012973|E4|Reported Event|Sham Treatment (Until Week 48)|Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
257330|NCT01012973|E3|Reported Event|Aflibercept Injection (Until Week 48)|Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
257331|NCT01012973|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
257332|NCT01012973|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
257333|NCT01012947|B6|Baseline|Total|Total of all reporting groups
257334|NCT01012947|B5|Baseline|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
257335|NCT01012947|B4|Baseline|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
257336|NCT01012947|B3|Baseline|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
257626|NCT01011868|O1|Outcome|Placebo|Oral Placebo
263529|NCT00996658|B3|Baseline|Total|Total of all reporting groups
257337|NCT01012947|B2|Baseline|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
257338|NCT01012947|B1|Baseline|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
257339|NCT01012947|P5|Participant Flow|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
257340|NCT01012947|P4|Participant Flow|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
257341|NCT01012947|P3|Participant Flow|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
257342|NCT01012947|P2|Participant Flow|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
257343|NCT01012947|P1|Participant Flow|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
257344|NCT01012947|O5|Outcome|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
257345|NCT01012947|O4|Outcome|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
257346|NCT01012947|O3|Outcome|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
257347|NCT01012947|O2|Outcome|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
257348|NCT01012947|O1|Outcome|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
257349|NCT01012947|E5|Reported Event|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
257350|NCT01012947|E4|Reported Event|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
257351|NCT01012947|E3|Reported Event|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
257352|NCT01012947|E2|Reported Event|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
257353|NCT01012947|E1|Reported Event|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
257354|NCT01012765|B1|Baseline|Safety Set|The safety set included all participants who received at least one dose of study medication during at least one study period.
257355|NCT01012765|P6|Participant Flow|Tiotropium - Indacaterol - Placebo|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257356|NCT01012765|P5|Participant Flow|Placebo - Tiotropium - Indacaterol|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257357|NCT01012765|P4|Participant Flow|Placebo - Indacaterol - Tiotropium|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257358|NCT01012765|P3|Participant Flow|Indacaterol - Tiotropium - Placebo|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257359|NCT01012765|P2|Participant Flow|Indacaterol - Placebo - Tiotropium|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257360|NCT01012765|P1|Participant Flow|Tiotropium - Placebo - Indacaterol|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257361|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257362|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257363|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257364|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257365|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257366|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257367|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257368|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257369|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257370|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257371|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257372|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257373|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257374|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257375|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257376|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257377|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257378|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257379|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257627|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257628|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257380|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257381|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257382|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257383|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257384|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257385|NCT01012765|E3|Reported Event|Tiotropium 18ug|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257386|NCT01012765|E2|Reported Event|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257387|NCT01012765|E1|Reported Event|Indacaterol 150ug|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
257388|NCT01012739|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257389|NCT01012739|P4|Participant Flow|Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg|In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257390|NCT01012739|P3|Participant Flow|Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg|In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257391|NCT01012739|P2|Participant Flow|Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo|In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257392|NCT01012739|P1|Participant Flow|Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg|In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257393|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257629|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257394|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257395|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257396|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257397|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257398|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257399|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257400|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257401|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257402|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257403|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257404|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257405|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257406|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257407|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257465|NCT01012440|P1|Participant Flow|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
257408|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257409|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257410|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257411|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257412|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257413|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257414|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257415|NCT01012739|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257416|NCT01012739|E3|Reported Event|Indacaterol 120 μg|Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257417|NCT01012739|E2|Reported Event|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257418|NCT01012739|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
257419|NCT01012713|B1|Baseline|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
257420|NCT01012713|P1|Participant Flow|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter."
257421|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than a 75% reduction in Psoriasis Area and Severity Index."
257422|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
257630|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257631|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257423|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
257424|NCT01012713|E1|Reported Event|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
257425|NCT01012674|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
257426|NCT01012674|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
257427|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
257428|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
257429|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
257430|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
257431|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
257432|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
257433|NCT01012674|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn from the study before Dotarem IV administration whatever the reason
257434|NCT01012674|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
257435|NCT01012674|E2|Reported Event|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
257436|NCT01012674|E1|Reported Event|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
257437|NCT01012661|B1|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
257438|NCT01012661|P1|Participant Flow|Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
257439|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
257440|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
257441|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
257442|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
257443|NCT01012661|E2|Reported Event|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
257444|NCT01012661|E1|Reported Event|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
257445|NCT01012622|B1|Baseline|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257446|NCT01012622|P1|Participant Flow|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257447|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257448|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257449|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257632|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257450|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257451|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257452|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257453|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257454|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257455|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257456|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257457|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257458|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257459|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257460|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257461|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257462|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257463|NCT01012622|E1|Reported Event|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
257464|NCT01012440|B1|Baseline|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
257633|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257466|NCT01012440|O1|Outcome|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
257467|NCT01012440|E1|Reported Event|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
257468|NCT01012414|B1|Baseline|Enrolled|Total number participants consentedand enrolled
257469|NCT01012414|P1|Participant Flow|All Participants|The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
257470|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
257471|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
257472|NCT01012414|O1|Outcome|Alll Participants|no arm /group title is provided as there was no enrollment.
257473|NCT01012414|O1|Outcome|All Participants|no arm /group title is provided as there was no enrollment.
257474|NCT01012414|E1|Reported Event|All Participants|All participants in the study.
257475|NCT01012388|B1|Baseline|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
257476|NCT01012388|P1|Participant Flow|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
257477|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
257478|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
257479|NCT01012388|E1|Reported Event|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
257480|NCT01012336|B1|Baseline|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
257481|NCT01012336|P1|Participant Flow|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
257482|NCT01012336|O1|Outcome|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
257483|NCT01012336|E1|Reported Event|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
257484|NCT01012258|B1|Baseline|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
257485|NCT01012258|P1|Participant Flow|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
257486|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
257487|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
257488|NCT01012258|E2|Reported Event|Cetuximab: Late Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
257634|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257635|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257489|NCT01012258|E1|Reported Event|Cetuximab: Treatment Emergent Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Treatment emergent phase, i.e. treatment-emergent adverse events (TEAEs, adverse events which occur or worsen on the first dosing day of trial treatment and until 60 days after the last trial treatment administration (cetuximab or radiotherapy).
257490|NCT01012245|B5|Baseline|Total|Total of all reporting groups
257491|NCT01012245|B4|Baseline|Other Medication|Subjects with other or no hypotensive therapy at baseline visit
257492|NCT01012245|B3|Baseline|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257493|NCT01012245|B2|Baseline|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
257494|NCT01012245|B1|Baseline|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257495|NCT01012245|P1|Participant Flow|Subjects With Glaucoma and Ocular Hypertension|All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
257496|NCT01012245|O2|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257497|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257498|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
257499|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257500|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
257501|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
257502|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
257503|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
257504|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257505|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
257506|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257507|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
257508|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257509|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257510|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
257511|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257512|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
257513|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257514|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
257515|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
257516|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257517|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
257518|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257519|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
257520|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
257521|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257522|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
257523|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257524|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
257525|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
257526|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
257527|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
257528|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
257529|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
257530|NCT01012245|E1|Reported Event|All Subjects|Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
257636|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257637|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257531|NCT01012219|B1|Baseline|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
257532|NCT01012219|P1|Participant Flow|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
257533|NCT01012219|O2|Outcome|Clopidogrel + Aspirin|Participants from Periods 1 and 2
257534|NCT01012219|O1|Outcome|Clopidogrel + Aspirin +Laropiprant|Participants from Periods 1 and 2
257535|NCT01012219|E3|Reported Event|Laropiprant + Niacin|Participants from Period 3
257536|NCT01012219|E2|Reported Event|Clopidogrel + Aspirin|Participants from Periods 1 and 2
257537|NCT01012219|E1|Reported Event|Laropiprant + Clopidrogel + Aspirin|Participants from Periods 1 and 2
257538|NCT01012037|B4|Baseline|Total|Total of all reporting groups
257539|NCT01012037|B3|Baseline|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257540|NCT01012037|B2|Baseline|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257541|NCT01012037|B1|Baseline|Placebo|Patients treated with matching placebo
257542|NCT01012037|P3|Participant Flow|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257543|NCT01012037|P2|Participant Flow|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257544|NCT01012037|P1|Participant Flow|Placebo|Patients treated with matching placebo
257545|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257546|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257547|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257548|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257549|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257550|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257551|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257552|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257553|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257554|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257555|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257556|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257557|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257558|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257559|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257560|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257561|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257562|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257563|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257564|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257565|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257566|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257567|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257568|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257569|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257570|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257571|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257572|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257573|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257574|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
257575|NCT01012037|E3|Reported Event|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
257576|NCT01012037|E2|Reported Event|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
257577|NCT01012037|E1|Reported Event|Placebo|Patients treated with matching placebo
257578|NCT01011946|B1|Baseline|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
257579|NCT01011946|P1|Participant Flow|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
257580|NCT01011946|O1|Outcome|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
257581|NCT01011946|E1|Reported Event|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
257583|NCT01011933|P1|Participant Flow|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257584|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257585|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257586|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257587|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257588|NCT01011933|E1|Reported Event|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
257589|NCT01011907|B3|Baseline|Total|Total of all reporting groups
257590|NCT01011907|B2|Baseline|Varenicline|
257591|NCT01011907|B1|Baseline|Placebo|
257592|NCT01011907|P2|Participant Flow|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
257593|NCT01011907|P1|Participant Flow|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
257594|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
257595|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
257596|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
257597|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
257598|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
257599|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
257600|NCT01011907|E2|Reported Event|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
257601|NCT01011907|E1|Reported Event|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
257602|NCT01011868|B4|Baseline|Total|Total of all reporting groups
257603|NCT01011868|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257604|NCT01011868|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257605|NCT01011868|B1|Baseline|Placebo|Oral Placebo
257606|NCT01011868|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257607|NCT01011868|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257608|NCT01011868|P1|Participant Flow|Placebo|Oral Placebo
257609|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257610|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257611|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257612|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257613|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257614|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257615|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257616|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257617|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257618|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257619|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257620|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257621|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257622|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257623|NCT01011868|O1|Outcome|Placebo|Oral Placebo
257624|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
257625|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257640|NCT01011868|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
257641|NCT01011868|E1|Reported Event|Placebo|Oral Placebo
257642|NCT01011829|B3|Baseline|Total|Total of all reporting groups
257643|NCT01011829|B2|Baseline|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
257644|NCT01011829|B1|Baseline|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
257645|NCT01011829|P2|Participant Flow|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
257646|NCT01011829|P1|Participant Flow|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
257647|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
257648|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
257649|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
257650|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
257651|NCT01011829|E2|Reported Event|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
257652|NCT01011829|E1|Reported Event|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
257653|NCT01011816|B3|Baseline|Total|Total of all reporting groups
257654|NCT01011816|B2|Baseline|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
257655|NCT01011816|B1|Baseline|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
257656|NCT01011816|P2|Participant Flow|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
257657|NCT01011816|P1|Participant Flow|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
257658|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
257659|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
257660|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
257661|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
257662|NCT01011816|O2|Outcome|Saline|"One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc~Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device"
257663|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|"One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc~BIOSTAT BIOLOGX: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device"
257664|NCT01011816|E2|Reported Event|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
257665|NCT01011816|E1|Reported Event|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
257666|NCT01011738|B4|Baseline|Total|Total of all reporting groups
257667|NCT01011738|B3|Baseline|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257668|NCT01011738|B2|Baseline|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257669|NCT01011738|B1|Baseline|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257670|NCT01011738|P3|Participant Flow|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257671|NCT01011738|P2|Participant Flow|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257672|NCT01011738|P1|Participant Flow|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257673|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257869|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257674|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257675|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257676|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257677|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257678|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257679|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257680|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257681|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257682|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257683|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257684|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257685|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257686|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257687|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257688|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257689|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257750|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257751|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257690|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257691|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257692|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257693|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257694|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257695|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257696|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257697|NCT01011738|O1|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257698|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257699|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257700|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257701|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257702|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257703|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257704|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257752|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257705|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257706|NCT01011738|E3|Reported Event|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
257707|NCT01011738|E2|Reported Event|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
257708|NCT01011738|E1|Reported Event|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
257709|NCT01011673|B3|Baseline|Total|Total of all reporting groups
257710|NCT01011673|B2|Baseline|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
257711|NCT01011673|B1|Baseline|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
257712|NCT01011673|P2|Participant Flow|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
257713|NCT01011673|P1|Participant Flow|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
257714|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
257715|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
257716|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
257717|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
257718|NCT01011673|E2|Reported Event|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
257719|NCT01011673|E1|Reported Event|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
257720|NCT01011634|B3|Baseline|Total|Total of all reporting groups
257721|NCT01011634|B2|Baseline|Oral Medication|
257722|NCT01011634|B1|Baseline|Moderate Sedation|
257723|NCT01011634|P2|Participant Flow|Oral Medication|
257724|NCT01011634|P1|Participant Flow|Moderate Sedation|
257725|NCT01011634|O2|Outcome|Oral Medication|
257726|NCT01011634|O1|Outcome|Moderate Sedation|
257727|NCT01011634|O2|Outcome|Oral Medication|
257728|NCT01011634|O1|Outcome|Moderate Sedation|
257729|NCT01011634|E2|Reported Event|IV Medications|
257730|NCT01011634|E1|Reported Event|Oral Medications|
257731|NCT01011556|B5|Baseline|Total|Total of all reporting groups
257732|NCT01011556|B4|Baseline|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257733|NCT01011556|B3|Baseline|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257734|NCT01011556|B2|Baseline|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257735|NCT01011556|B1|Baseline|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257736|NCT01011556|P4|Participant Flow|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257737|NCT01011556|P3|Participant Flow|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257738|NCT01011556|P2|Participant Flow|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257739|NCT01011556|P1|Participant Flow|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257740|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257741|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257742|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257743|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257744|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257745|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257746|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257747|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257748|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257749|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257859|NCT01011309|P3|Participant Flow|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
257753|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257754|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257755|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257756|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257757|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257758|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257759|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257760|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257761|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257762|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257763|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.
257764|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257765|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257766|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257767|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257768|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257769|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257770|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257771|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257772|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257773|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257774|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257775|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257776|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257777|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257778|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257779|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257780|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257781|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257782|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257783|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
257784|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257785|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257786|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level
257787|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
257788|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257789|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257790|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257791|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
257792|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257975|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257793|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257794|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257795|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257796|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257797|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257798|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257799|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257800|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257801|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257802|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257803|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
257804|NCT01011556|E4|Reported Event|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257805|NCT01011556|E3|Reported Event|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257806|NCT01011556|E2|Reported Event|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
257807|NCT01011556|E1|Reported Event|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
257808|NCT01011465|B9|Baseline|Total|Total of all reporting groups
257809|NCT01011465|B8|Baseline|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257810|NCT01011465|B7|Baseline|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257811|NCT01011465|B6|Baseline|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257812|NCT01011465|B5|Baseline|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257813|NCT01011465|B4|Baseline|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257860|NCT01011309|P2|Participant Flow|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257861|NCT01011309|P1|Participant Flow|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257862|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
257976|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257814|NCT01011465|B3|Baseline|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257815|NCT01011465|B2|Baseline|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257816|NCT01011465|B1|Baseline|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257817|NCT01011465|P8|Participant Flow|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257818|NCT01011465|P7|Participant Flow|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257819|NCT01011465|P6|Participant Flow|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257820|NCT01011465|P5|Participant Flow|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257821|NCT01011465|P4|Participant Flow|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257822|NCT01011465|P3|Participant Flow|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257863|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257864|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257865|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
257977|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257823|NCT01011465|P2|Participant Flow|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257824|NCT01011465|P1|Participant Flow|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257825|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
257826|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
257827|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
257828|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
257829|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
257830|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
257831|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
257832|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
257833|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
257834|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
257835|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
257836|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
257837|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
257838|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
257839|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
257840|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
257841|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
257842|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
257866|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257867|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257868|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
263530|NCT00996658|B2|Baseline|Linagliptin 5 mg Tablet|
257843|NCT01011465|E8|Reported Event|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257844|NCT01011465|E7|Reported Event|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257845|NCT01011465|E6|Reported Event|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257846|NCT01011465|E5|Reported Event|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257847|NCT01011465|E4|Reported Event|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257848|NCT01011465|E3|Reported Event|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257849|NCT01011465|E2|Reported Event|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
257850|NCT01011465|E1|Reported Event|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
257851|NCT01011387|B1|Baseline|NPWT System|Negative Pressure Wound Therapy
257852|NCT01011387|P1|Participant Flow|Negative Pressure Wound Therapy System|The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
257853|NCT01011387|O1|Outcome|NPWT System|Negative Pressure Wound Therapy
257854|NCT01011387|E1|Reported Event|NPWT System|Negative Pressure Wound Therapy
257855|NCT01011309|B4|Baseline|Total|Total of all reporting groups
257856|NCT01011309|B3|Baseline|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
257857|NCT01011309|B2|Baseline|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257858|NCT01011309|B1|Baseline|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257870|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257871|NCT01011309|E3|Reported Event|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
257872|NCT01011309|E2|Reported Event|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
257873|NCT01011309|E1|Reported Event|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
257874|NCT01011283|B3|Baseline|Total|Total of all reporting groups
257875|NCT01011283|B2|Baseline|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
257876|NCT01011283|B1|Baseline|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
257877|NCT01011283|P2|Participant Flow|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
257878|NCT01011283|P1|Participant Flow|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
257879|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
257880|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
257881|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
257882|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
257883|NCT01011283|E2|Reported Event|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
257884|NCT01011283|E1|Reported Event|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
257885|NCT01011179|B3|Baseline|Total|Total of all reporting groups
257886|NCT01011179|B2|Baseline|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
257887|NCT01011179|B1|Baseline|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
257888|NCT01011179|P2|Participant Flow|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
257889|NCT01011179|P1|Participant Flow|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
257890|NCT01011179|O2|Outcome|Attention Control Group|"Self-Management: Adolescents' own best efforts at managing their JIA"
257891|NCT01011179|O1|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge: The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
257892|NCT01011179|E2|Reported Event|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
257893|NCT01011179|E1|Reported Event|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
257894|NCT01011153|B4|Baseline|Total|Total of all reporting groups
257895|NCT01011153|B3|Baseline|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
257896|NCT01011153|B2|Baseline|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
257897|NCT01011153|B1|Baseline|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
257898|NCT01011153|P3|Participant Flow|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
257899|NCT01011153|P2|Participant Flow|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
257900|NCT01011153|P1|Participant Flow|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
257901|NCT01011153|O3|Outcome|Primary Care Physicians|
257902|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|
257903|NCT01011153|O1|Outcome|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
257904|NCT01011153|O4|Outcome|All Partipants|All Participants are the General Dermatologists, Pigmented Skin Lesion Experts and Primary Care Physicians combined.
257905|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
257906|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
257907|NCT01011153|O1|Outcome|Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
257908|NCT01011153|O4|Outcome|MelaFind|MelaFind imaged the 130 cases, the 65 positive cases (i.e., histologically confirmed melanoma) and the 65 negative cases (i.e., histologically confirmed non-melanoma). Sensitivity was calculated based on the correct identification of the 65 positive cases and specificity was calculated based on the correct identification of the 65 negative cases.
257909|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
257910|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
257911|NCT01011153|O1|Outcome|General Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
257912|NCT01011153|O2|Outcome|MelaFind|MelaFind imaged 130 cases which consisted of 65 positive cases (i.e., histolgoically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
257913|NCT01011153|O1|Outcome|Dermatologists|Dermatologists were defined as board-certified dermatologists who were General Dermatologists and Pigmented Skin Lesion Experts, according to the Intake Survey. Dermatologists in this group did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consistinf of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
257914|NCT01011153|E3|Reported Event|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
257915|NCT01011153|E2|Reported Event|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
257916|NCT01011153|E1|Reported Event|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
257917|NCT01011075|B1|Baseline|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257918|NCT01011075|P1|Participant Flow|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257919|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257920|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257921|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257922|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257923|NCT01011075|E1|Reported Event|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
257924|NCT01011049|B5|Baseline|Total|Total of all reporting groups
257925|NCT01011049|B4|Baseline|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257926|NCT01011049|B3|Baseline|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257927|NCT01011049|B2|Baseline|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
263531|NCT00996658|B1|Baseline|Placebo Tablet|
257928|NCT01011049|B1|Baseline|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257929|NCT01011049|P4|Participant Flow|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257930|NCT01011049|P3|Participant Flow|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257931|NCT01011049|P2|Participant Flow|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257932|NCT01011049|P1|Participant Flow|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257933|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257934|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257935|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257936|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257937|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257938|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257939|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257940|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257941|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257942|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257943|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257944|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257945|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257946|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257947|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257948|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257949|NCT01011049|E4|Reported Event|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
257950|NCT01011049|E3|Reported Event|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
257951|NCT01011049|E2|Reported Event|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
257952|NCT01011049|E1|Reported Event|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
257953|NCT01010971|B4|Baseline|Total|Total of all reporting groups
257954|NCT01010971|B3|Baseline|Placebo|Placebo once daily
257955|NCT01010971|B2|Baseline|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257956|NCT01010971|B1|Baseline|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257957|NCT01010971|P3|Participant Flow|Placebo|Placebo once daily
257958|NCT01010971|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257959|NCT01010971|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257960|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257961|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257962|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257963|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257964|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257965|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257966|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257967|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257968|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257969|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257970|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257971|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257972|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257973|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257974|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257978|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257979|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257980|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257981|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257982|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257983|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257984|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257985|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257986|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257987|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257988|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257989|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257990|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257991|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257992|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257993|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257994|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257995|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257996|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
257997|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
257998|NCT01010971|O3|Outcome|Placebo|Placebo once daily
257999|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258000|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258001|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258002|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258003|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258004|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258005|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258006|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258007|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258008|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258009|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258010|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258011|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258012|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258013|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258014|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258015|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258016|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258017|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258018|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258019|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258020|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258021|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258022|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258023|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258024|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258025|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258026|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258027|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258028|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258029|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258030|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258031|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258032|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258033|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258034|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258035|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258036|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258037|NCT01010971|O3|Outcome|Placebo|Placebo once daily
258038|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258039|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258040|NCT01010971|E3|Reported Event|Placebo|Placebo once daily
258041|NCT01010971|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
258042|NCT01010971|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
258043|NCT01010932|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
258044|NCT01010932|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
258045|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
258046|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
258047|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
264020|NCT00995930|O1|Outcome|Placebo|SQ monthly
258048|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
258049|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
258050|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
258051|NCT01010932|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn before administration of Dotarem whatever the reason
258052|NCT01010932|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium
258053|NCT01010932|E2|Reported Event|TOF MRA|Patients benefiting from a MR angiography with no contrast medium administration
258054|NCT01010932|E1|Reported Event|Dotarem MRA|Patients benefiting from a MR angiography after an IV administration of Dotarem
258055|NCT01010906|B7|Baseline|Total|Total of all reporting groups
258056|NCT01010906|B6|Baseline|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
258057|NCT01010906|B5|Baseline|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
258058|NCT01010906|B4|Baseline|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258059|NCT01010906|B3|Baseline|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
258060|NCT01010906|B2|Baseline|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258061|NCT01010906|B1|Baseline|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
258062|NCT01010906|P6|Participant Flow|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
258063|NCT01010906|P5|Participant Flow|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
258064|NCT01010906|P4|Participant Flow|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258065|NCT01010906|P3|Participant Flow|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
258066|NCT01010906|P2|Participant Flow|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258067|NCT01010906|P1|Participant Flow|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
258068|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
258069|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
258070|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258071|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
258072|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258073|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
258074|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
258075|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
258076|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258077|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
258078|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258079|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
258080|NCT01010906|E6|Reported Event|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
258081|NCT01010906|E5|Reported Event|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
258082|NCT01010906|E4|Reported Event|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258083|NCT01010906|E3|Reported Event|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
258084|NCT01010906|E2|Reported Event|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
258085|NCT01010906|E1|Reported Event|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
258086|NCT01010776|B1|Baseline|Paliperidone ER - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258087|NCT01010776|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258088|NCT01010776|O1|Outcome|Paliperidone ER-Main Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258089|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator’s discretion.
258736|NCT01008995|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258090|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258091|NCT01010776|O1|Outcome|Paliperidone ER- Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258092|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258093|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258094|NCT01010776|O1|Outcome|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258095|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258096|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258097|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258098|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258099|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258100|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258101|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258102|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258103|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258104|NCT01010776|O1|Outcome|Paliperidone (ER) - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258105|NCT01010776|O1|Outcome|Paliperidone Extended Release (ER) - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258106|NCT01010776|E2|Reported Event|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
258107|NCT01010776|E1|Reported Event|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
258108|NCT01010750|B7|Baseline|Total|Total of all reporting groups
258109|NCT01010750|B6|Baseline|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|
258110|NCT01010750|B5|Baseline|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|
258111|NCT01010750|B4|Baseline|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|
258112|NCT01010750|B3|Baseline|Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg|
258113|NCT01010750|B2|Baseline|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|
258114|NCT01010750|B1|Baseline|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|
258115|NCT01010750|P6|Participant Flow|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
258116|NCT01010750|P5|Participant Flow|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
258117|NCT01010750|P4|Participant Flow|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
258118|NCT01010750|P3|Participant Flow|Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg|LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
258371|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
258119|NCT01010750|P2|Participant Flow|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
258120|NCT01010750|P1|Participant Flow|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
258121|NCT01010750|O3|Outcome|Placebo|
258122|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258123|NCT01010750|O1|Outcome|LDX 50 mg|
258124|NCT01010750|O3|Outcome|Placebo|
258125|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258126|NCT01010750|O1|Outcome|LDX 50 mg|
258127|NCT01010750|O3|Outcome|Placebo|
258128|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258129|NCT01010750|O1|Outcome|LDX 50 mg|
258130|NCT01010750|O3|Outcome|Placebo|
258131|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258132|NCT01010750|O1|Outcome|LDX 50 mg|
258133|NCT01010750|O3|Outcome|Placebo|
258134|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258135|NCT01010750|O1|Outcome|LDX 50 mg|
258136|NCT01010750|O3|Outcome|Placebo|
258137|NCT01010750|O2|Outcome|MAS-IR 20 mg|
258138|NCT01010750|O1|Outcome|LDX 50 mg|
258139|NCT01010750|E3|Reported Event|Placebo|
258140|NCT01010750|E2|Reported Event|MAS-IR 20 mg|
258141|NCT01010750|E1|Reported Event|LDX 50 mg|
258142|NCT01010633|B3|Baseline|Total|Total of all reporting groups
258143|NCT01010633|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate
258144|NCT01010633|B1|Baseline|Loteprednol|Loteprednol etabonate 0.5%
258145|NCT01010633|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate
258146|NCT01010633|P1|Participant Flow|Loteprednol|Loteprednol etabonate 0.5%
258147|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
258148|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
258149|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
258150|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
258151|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
258152|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
258153|NCT01010633|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate
258154|NCT01010633|E1|Reported Event|Loteprednol|Loteprednol etabonate 0.5%
258155|NCT01010568|B1|Baseline|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
258156|NCT01010568|P1|Participant Flow|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
258157|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
258158|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
258159|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
258160|NCT01010568|E1|Reported Event|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
258161|NCT01010555|B1|Baseline|Overall|This reporting group includes all enrolled subjects.
258162|NCT01010555|P2|Participant Flow|Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A|Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
258163|NCT01010555|P1|Participant Flow|Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A|Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
258164|NCT01010555|O4|Outcome|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258165|NCT01010555|O3|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258166|NCT01010555|O2|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258167|NCT01010555|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258168|NCT01010555|E4|Reported Event|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258169|NCT01010555|E3|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258170|NCT01010555|E2|Reported Event|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258171|NCT01010555|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
258172|NCT01010503|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258173|NCT01010503|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258459|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258174|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258175|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258176|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258177|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258178|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258179|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258180|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258181|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258182|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258183|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258184|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258185|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258186|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258187|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258188|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258189|NCT01010503|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
258190|NCT01010477|B3|Baseline|Total|Total of all reporting groups
258191|NCT01010477|B2|Baseline|Placebo NS|Receives placebo (piperine containing) nasal spray
258192|NCT01010477|B1|Baseline|NNS Active|Receives nicotine (active) nasal spray
258193|NCT01010477|P2|Participant Flow|Placebo|Receives placebo (piperine)nasal spray
258194|NCT01010477|P1|Participant Flow|NNS Active|Receives active nicotine containing Nasal spray
258195|NCT01010477|O2|Outcome|Placebo|Receives placebo (piperine)nasal spray
258196|NCT01010477|O1|Outcome|NNS Active|Receives nicotine (active ) nasal spray
258197|NCT01010477|E2|Reported Event|Placebo|Receives placebo (piperine)nasal spray
258198|NCT01010477|E1|Reported Event|NNS Active|Receives nicotine (active) nasal spray
258199|NCT01010399|B1|Baseline|Boosted Lexiva With Lovaza|
258200|NCT01010399|P1|Participant Flow|Boosted Lexiva With Lovaza|
258201|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
258202|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
258203|NCT01010399|E1|Reported Event|Boosted Lexiva With Lovaza|
258204|NCT01010282|B4|Baseline|Total|Total of all reporting groups
258205|NCT01010282|B3|Baseline|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258206|NCT01010282|B2|Baseline|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258207|NCT01010282|B1|Baseline|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258208|NCT01010282|P3|Participant Flow|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258209|NCT01010282|P2|Participant Flow|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258210|NCT01010282|P1|Participant Flow|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258211|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258212|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258213|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258214|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258215|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258216|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258217|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258218|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258219|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258220|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258221|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258222|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258223|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258224|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258225|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258226|NCT01010282|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
258227|NCT01010282|E2|Reported Event|Artificial Tears Formulation 2|Artificial Tears Formulation 2
258228|NCT01010282|E1|Reported Event|Artificial Tears Formulation 1|Artificial Tears Formulation 1
258229|NCT01010230|B3|Baseline|Total|Total of all reporting groups
258655|NCT01009099|P2|Participant Flow|Exercise Training|treadmill exercise training
258230|NCT01010230|B2|Baseline|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258231|NCT01010230|B1|Baseline|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258232|NCT01010230|P2|Participant Flow|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258233|NCT01010230|P1|Participant Flow|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258234|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258235|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258236|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258237|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258238|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258239|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258240|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258241|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258372|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
258373|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
258242|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258243|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258244|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258245|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258246|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258247|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258248|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258249|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258250|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258251|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258252|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258253|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258374|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
258375|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
258254|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258255|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258256|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258257|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258258|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258259|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258260|NCT01010230|E2|Reported Event|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
258261|NCT01010230|E1|Reported Event|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
258262|NCT01010204|B3|Baseline|Total|Total of all reporting groups
258263|NCT01010204|B2|Baseline|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258264|NCT01010204|B1|Baseline|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258265|NCT01010204|P2|Participant Flow|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258281|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258266|NCT01010204|P1|Participant Flow|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258267|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258268|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258269|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258270|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258271|NCT01010204|E2|Reported Event|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258272|NCT01010204|E1|Reported Event|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
258273|NCT01010061|B3|Baseline|Total|Total of all reporting groups
258274|NCT01010061|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258275|NCT01010061|B1|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258276|NCT01010061|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258277|NCT01010061|P1|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258278|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258279|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258280|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258282|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258283|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258284|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258285|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258286|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258287|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258288|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258289|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258290|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258291|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258292|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258293|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258294|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258295|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258296|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258297|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258298|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258299|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258300|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258301|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258302|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258303|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258304|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258305|NCT01010061|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
258306|NCT01010061|E1|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
258307|NCT01010009|B4|Baseline|Total|Total of all reporting groups
258308|NCT01010009|B3|Baseline|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
258309|NCT01010009|B2|Baseline|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
258310|NCT01010009|B1|Baseline|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
258311|NCT01010009|P3|Participant Flow|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
258312|NCT01010009|P2|Participant Flow|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
258313|NCT01010009|P1|Participant Flow|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
258314|NCT01010009|O3|Outcome|Placebo|
258315|NCT01010009|O2|Outcome|Resveratrol 500mg|
258316|NCT01010009|O1|Outcome|Resveratrol 250mg|
258317|NCT01010009|O3|Outcome|Placebo|
258318|NCT01010009|O2|Outcome|Resveratrol 500mg|
258319|NCT01010009|O1|Outcome|Resveratrol 250mg|
258320|NCT01010009|O3|Outcome|Placebo|
258321|NCT01010009|O2|Outcome|Resveratrol 500mg|
258322|NCT01010009|O1|Outcome|Resveratrol 250mg|
258323|NCT01010009|E3|Reported Event|Placebo|
258324|NCT01010009|E2|Reported Event|Resveratrol 500mg|
258325|NCT01010009|E1|Reported Event|Resveratrol 250mg|
258326|NCT01009983|B1|Baseline|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
258327|NCT01009983|P1|Participant Flow|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
258328|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
258329|NCT01009983|E1|Reported Event|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
258330|NCT01009931|B1|Baseline|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258331|NCT01009931|P1|Participant Flow|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258332|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258333|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258334|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258335|NCT01009931|E1|Reported Event|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
258775|NCT01008696|B3|Baseline|Total|Total of all reporting groups
258336|NCT01009840|B1|Baseline|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258337|NCT01009840|P1|Participant Flow|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
258338|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258339|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258340|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258341|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258342|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258343|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258344|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258345|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258346|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258347|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258348|NCT01009840|E1|Reported Event|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
258349|NCT01009762|B3|Baseline|Total|Total of all reporting groups
258350|NCT01009762|B2|Baseline|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
258351|NCT01009762|B1|Baseline|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
258352|NCT01009762|P2|Participant Flow|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
258353|NCT01009762|P1|Participant Flow|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
258354|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
258355|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
258356|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
258357|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
258358|NCT01009762|O2|Outcome|Placebo|participants receiving placebo (=saline)
258359|NCT01009762|O1|Outcome|Vaccinee|participants receiving the vaccine
258360|NCT01009762|E2|Reported Event|Placebo|Participants receiving placebo (saline)
258361|NCT01009762|E1|Reported Event|Vaccinee|"participants receiving the vaccine called AFO-18"
258362|NCT01009645|B5|Baseline|Total|Total of all reporting groups
258363|NCT01009645|B4|Baseline|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
258364|NCT01009645|B3|Baseline|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
258365|NCT01009645|B2|Baseline|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
258366|NCT01009645|B1|Baseline|Fact Only|The educational message used will contain facts only.
258367|NCT01009645|P4|Participant Flow|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
258368|NCT01009645|P3|Participant Flow|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
258369|NCT01009645|P2|Participant Flow|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
258370|NCT01009645|P1|Participant Flow|Fact Only|The educational message used will contain facts only.
264021|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
258376|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
258377|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
258378|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
258379|NCT01009645|E4|Reported Event|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
258380|NCT01009645|E3|Reported Event|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
258381|NCT01009645|E2|Reported Event|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
258382|NCT01009645|E1|Reported Event|Fact Only|The educational message used will contain facts only.
258383|NCT01009619|B3|Baseline|Total|Total of all reporting groups
258384|NCT01009619|B2|Baseline|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258385|NCT01009619|B1|Baseline|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258386|NCT01009619|P2|Participant Flow|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258387|NCT01009619|P1|Participant Flow|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258388|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258389|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258390|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258391|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258392|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258393|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258394|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258395|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258396|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258397|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258398|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258399|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258400|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258401|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258402|NCT01009619|E2|Reported Event|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
258403|NCT01009619|E1|Reported Event|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
258404|NCT01009580|B3|Baseline|Total|Total of all reporting groups
258405|NCT01009580|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258406|NCT01009580|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258407|NCT01009580|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258408|NCT01009580|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258409|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258410|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258411|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258412|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258413|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258414|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258415|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258416|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258417|NCT01009580|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
258418|NCT01009580|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
258419|NCT01009554|B3|Baseline|Total|Total of all reporting groups
258420|NCT01009554|B2|Baseline|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258421|NCT01009554|B1|Baseline|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258422|NCT01009554|P2|Participant Flow|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258423|NCT01009554|P1|Participant Flow|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258424|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258425|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258426|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258427|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258428|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258429|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258430|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258431|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258432|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258433|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258434|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258435|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258436|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258437|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258438|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258439|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258440|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258441|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258442|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258443|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258444|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258445|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258446|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258447|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258448|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258449|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258450|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258451|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258452|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258453|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258454|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258455|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258456|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258457|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258458|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258460|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258461|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258462|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258463|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258464|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258465|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258466|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258467|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258468|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258469|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258470|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258471|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258472|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258473|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258474|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258475|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258476|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258477|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258478|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258479|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258480|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258481|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258482|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258483|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258484|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258485|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258486|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258487|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258488|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258489|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258490|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258491|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258492|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258493|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258494|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258495|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258496|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258497|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258498|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258499|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258500|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258501|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258502|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258503|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258504|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258505|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258506|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258507|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258508|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258509|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258510|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258511|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258512|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258513|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258514|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258515|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258516|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258517|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258518|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258519|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258520|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258521|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258522|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258523|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258524|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258525|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258526|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258527|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258528|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258529|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258530|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258531|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258532|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258533|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258534|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258535|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258536|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258537|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258538|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258539|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258540|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258541|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258542|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258543|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258544|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258545|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
264022|NCT00995930|O1|Outcome|Placebo|SQ monthly
258546|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258547|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258548|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258549|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258550|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258551|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258552|NCT01009554|E2|Reported Event|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
258553|NCT01009554|E1|Reported Event|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
258554|NCT01009515|B1|Baseline|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258555|NCT01009515|P1|Participant Flow|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258556|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258557|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258558|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258559|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258560|NCT01009515|E1|Reported Event|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
258561|NCT01009463|B5|Baseline|Total|Total of all reporting groups
258562|NCT01009463|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258563|NCT01009463|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258564|NCT01009463|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258565|NCT01009463|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258566|NCT01009463|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258567|NCT01009463|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258568|NCT01009463|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258569|NCT01009463|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258570|NCT01009463|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
258571|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258572|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258573|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258574|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258575|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258576|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258577|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258578|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258579|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258580|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258581|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258582|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
258583|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258584|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258585|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258586|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258587|NCT01009463|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258588|NCT01009463|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258589|NCT01009463|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258590|NCT01009463|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
258591|NCT01009346|B1|Baseline|Study Arm|"Drug: RAD001~Other Names:~Everolimus~Dose Level -1 2.5mg/day~Dose Level 1 5mg/day*~Dose Level 2 10mg/day~MTD RAD001 Drug: Cetuximab~Other Names:~Erbitux~250mg/m2/week Drug: Cisplatin~Other Names:~cisplatinum CDDP cis-diamminedichloroplatinum(II)~40mg/m2 Day 1, 8 every 28 days Drug: Carboplatin~Other Names:~cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)~Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
258656|NCT01009099|P1|Participant Flow|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
258657|NCT01009099|O2|Outcome|Exercise Training|treadmill exercise training
258592|NCT01009346|P1|Participant Flow|Group 1|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
258593|NCT01009346|O1|Outcome|Study Arm (RAD001)|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
258594|NCT01009346|E1|Reported Event|Group 1|
258595|NCT01009333|B1|Baseline|All Study Participants|
258596|NCT01009333|P6|Participant Flow|Start at 25 Hz, Then 14 Hz, Then 5.2 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
258597|NCT01009333|P5|Participant Flow|Start at 25 Hz, Then 5.2 Hz, Then 14 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
258598|NCT01009333|P4|Participant Flow|Start at 14 Hz, Then 25 Hz, Then 5.2 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
258599|NCT01009333|P3|Participant Flow|Start at 14 Hz, Then 5.2 Hz, Then 25 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
258600|NCT01009333|P2|Participant Flow|Start at 5.2 Hz, Then 25 Hz, Then 14 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
258601|NCT01009333|P1|Participant Flow|Start at 5.2 Hz, Then 14 Hz, Then 25 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
258602|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
258603|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
258604|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
258605|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
258606|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
258607|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
258608|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
258609|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
258610|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
258611|NCT01009333|E3|Reported Event|High InterStim Rate Setting at 25 Hz|
258612|NCT01009333|E2|Reported Event|Medium InterStim Rate Setting at 14 Hz|
258613|NCT01009333|E1|Reported Event|Low InterStim Rate Setting at 5.2 Hz|
258614|NCT01009203|B1|Baseline|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258615|NCT01009203|P1|Participant Flow|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258616|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258617|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258618|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258619|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258620|NCT01009203|E1|Reported Event|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
258621|NCT01009138|B3|Baseline|Total|Total of all reporting groups
258622|NCT01009138|B2|Baseline|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258623|NCT01009138|B1|Baseline|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258658|NCT01009099|O1|Outcome|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
258624|NCT01009138|P2|Participant Flow|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258625|NCT01009138|P1|Participant Flow|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258626|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258627|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258628|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258629|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258630|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258631|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258632|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258633|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258634|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258635|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258636|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258637|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258659|NCT01009099|E2|Reported Event|Exercise Training|treadmill exercise training
258660|NCT01009099|E1|Reported Event|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
258661|NCT01009086|B4|Baseline|Total|Total of all reporting groups
259077|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
258638|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258639|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258640|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258641|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258642|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258643|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258644|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258645|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258646|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258647|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258648|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258649|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258650|NCT01009138|E2|Reported Event|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
258651|NCT01009138|E1|Reported Event|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
258652|NCT01009099|B3|Baseline|Total|Total of all reporting groups
258653|NCT01009099|B2|Baseline|Arm 2|"exercise training~exercise training: treadmill exercise training"
258654|NCT01009099|B1|Baseline|Arm 1|"exercise training with breathing retraining~breathing retraining: breathing retraining using a metronome~exercise training: treadmill exercise training"
258662|NCT01009086|B3|Baseline|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
258663|NCT01009086|B2|Baseline|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
258664|NCT01009086|B1|Baseline|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
258665|NCT01009086|P3|Participant Flow|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
258666|NCT01009086|P2|Participant Flow|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
258667|NCT01009086|P1|Participant Flow|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
258668|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258669|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258670|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258671|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258672|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258673|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258674|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258675|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258676|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258677|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258678|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258679|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258680|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258681|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258682|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258708|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258735|NCT01008995|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258683|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258684|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258685|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258686|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258687|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258688|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
258689|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258690|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
258691|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
258692|NCT01009086|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
258693|NCT01009086|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
258694|NCT01009086|E5|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
258695|NCT01009086|E4|Reported Event|Placebo (After CP)|After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
258696|NCT01009086|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
258697|NCT01009086|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
258698|NCT01009086|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
258699|NCT01009047|B3|Baseline|Total|Total of all reporting groups
258700|NCT01009047|B2|Baseline|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258701|NCT01009047|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258702|NCT01009047|P2|Participant Flow|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258703|NCT01009047|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258704|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258705|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258706|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258707|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258734|NCT01008995|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
258709|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258710|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258711|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258712|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258713|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258714|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258715|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258716|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258717|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258718|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258719|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258720|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258721|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258722|NCT01009047|E2|Reported Event|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
258723|NCT01009047|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
258724|NCT01009034|B1|Baseline|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258725|NCT01009034|P1|Participant Flow|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258726|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258727|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258728|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258729|NCT01009034|E1|Reported Event|12 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
258730|NCT01008995|B3|Baseline|Total|Total of all reporting groups
258731|NCT01008995|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258732|NCT01008995|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258733|NCT01008995|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
264023|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
258737|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258738|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258739|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258740|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258741|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258742|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258743|NCT01008995|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
258744|NCT01008995|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
258745|NCT01008995|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
258746|NCT01008995|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
258747|NCT01008969|B1|Baseline|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
258748|NCT01008969|P1|Participant Flow|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
258749|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
258750|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
258751|NCT01008969|E1|Reported Event|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
258752|NCT01008943|B1|Baseline|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258753|NCT01008943|P1|Participant Flow|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258754|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258755|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258756|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258757|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258758|NCT01008943|E1|Reported Event|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
258759|NCT01008904|B1|Baseline|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
258760|NCT01008904|P1|Participant Flow|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
258761|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
258762|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
258763|NCT01008904|E1|Reported Event|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
258764|NCT01008722|B3|Baseline|Total|Total of all reporting groups
258765|NCT01008722|B2|Baseline|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
258766|NCT01008722|B1|Baseline|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
258767|NCT01008722|P2|Participant Flow|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
258768|NCT01008722|P1|Participant Flow|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
258769|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
258770|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
258771|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
258772|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
258773|NCT01008722|E2|Reported Event|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
258774|NCT01008722|E1|Reported Event|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
258776|NCT01008696|B2|Baseline|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
258777|NCT01008696|B1|Baseline|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
258778|NCT01008696|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
258779|NCT01008696|P1|Participant Flow|Rabeprazole|Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
258780|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
258781|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
258782|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
258783|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
258784|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
258785|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
258786|NCT01008696|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
258787|NCT01008696|E1|Reported Event|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
258788|NCT01008618|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258789|NCT01008618|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258790|NCT01008618|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258791|NCT01008618|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258792|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258793|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258794|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258795|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258796|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
259034|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
258797|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258798|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258799|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258800|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258801|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258802|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258803|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258804|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258805|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258806|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258807|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258808|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258828|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
259035|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
258809|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258810|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258811|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258812|NCT01008618|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258813|NCT01008618|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258814|NCT01008618|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258815|NCT01008605|B1|Baseline|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258816|NCT01008605|P1|Participant Flow|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258817|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
258818|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
258819|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
258820|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
258821|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
258822|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
258823|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
258824|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
258825|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
258826|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
258827|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
258829|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
258830|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
258831|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
258832|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
258833|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258834|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258835|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258836|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258837|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258838|NCT01008605|E1|Reported Event|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
258839|NCT01008553|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258840|NCT01008553|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258841|NCT01008553|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258842|NCT01008553|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258843|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258844|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258845|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
259036|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
258846|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258847|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258848|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258849|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258850|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258851|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258852|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258853|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258854|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258855|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258856|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258857|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258908|NCT01008449|B2|Baseline|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
259037|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
258858|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258859|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258860|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258861|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258862|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258863|NCT01008553|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258864|NCT01008553|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
258865|NCT01008553|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
258866|NCT01008475|B8|Baseline|Total|Total of all reporting groups
258867|NCT01008475|B7|Baseline|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258868|NCT01008475|B6|Baseline|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258869|NCT01008475|B5|Baseline|Randomized Part: SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258870|NCT01008475|B4|Baseline|Safety Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258871|NCT01008475|B3|Baseline|Safety Part: EMD 525797 750 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258872|NCT01008475|B2|Baseline|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258873|NCT01008475|B1|Baseline|Safety Part: EMD 525797 250 mg + Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258874|NCT01008475|P7|Participant Flow|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258875|NCT01008475|P6|Participant Flow|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258876|NCT01008475|P5|Participant Flow|Randomized Part: Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258877|NCT01008475|P4|Participant Flow|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258878|NCT01008475|P3|Participant Flow|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258879|NCT01008475|P2|Participant Flow|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258880|NCT01008475|P1|Participant Flow|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258881|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258882|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
264024|NCT00995930|O1|Outcome|Placebo|SQ monthly
258883|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258884|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258885|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258886|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258887|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258888|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258889|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258890|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258891|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258892|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258893|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258894|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258909|NCT01008449|B1|Baseline|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
259074|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
258895|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258896|NCT01008475|O4|Outcome|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258897|NCT01008475|O3|Outcome|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258898|NCT01008475|O2|Outcome|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258899|NCT01008475|O1|Outcome|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258900|NCT01008475|E7|Reported Event|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258901|NCT01008475|E6|Reported Event|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258902|NCT01008475|E5|Reported Event|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258903|NCT01008475|E4|Reported Event|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258904|NCT01008475|E3|Reported Event|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258905|NCT01008475|E2|Reported Event|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258906|NCT01008475|E1|Reported Event|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
258907|NCT01008449|B3|Baseline|Total|Total of all reporting groups
259075|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
258910|NCT01008449|P2|Participant Flow|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258911|NCT01008449|P1|Participant Flow|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258912|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258913|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258914|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258915|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258916|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258917|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258918|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258919|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258920|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258921|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258922|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258923|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258924|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258925|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258926|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258927|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258928|NCT01008449|E2|Reported Event|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
258929|NCT01008449|E1|Reported Event|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
258930|NCT01008280|B3|Baseline|Total|Total of all reporting groups
258931|NCT01008280|B2|Baseline|Placebo|"placebo given tid~placebo: placebo pill tid"
258932|NCT01008280|B1|Baseline|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258933|NCT01008280|P2|Participant Flow|Placebo|"placebo given tid~placebo: placebo pill tid"
258934|NCT01008280|P1|Participant Flow|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258935|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
258936|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258937|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
258938|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258939|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
258940|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258941|NCT01008280|E2|Reported Event|Placebo|"placebo given tid~placebo: placebo pill tid"
258942|NCT01008280|E1|Reported Event|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
258943|NCT01007916|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
258944|NCT01007916|P2|Participant Flow|Habitual / Lotrafilcon B|Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
259032|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259076|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
258945|NCT01007916|P1|Participant Flow|Lotrafilcon B / Habitual|Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
258946|NCT01007916|O2|Outcome|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
258947|NCT01007916|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
258948|NCT01007916|E2|Reported Event|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
258949|NCT01007916|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
258950|NCT01007838|B5|Baseline|Total|Total of all reporting groups
258951|NCT01007838|B4|Baseline|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258952|NCT01007838|B3|Baseline|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258953|NCT01007838|B2|Baseline|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258954|NCT01007838|B1|Baseline|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258955|NCT01007838|P4|Participant Flow|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258956|NCT01007838|P3|Participant Flow|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258957|NCT01007838|P2|Participant Flow|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258958|NCT01007838|P1|Participant Flow|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258959|NCT01007838|O4|Outcome|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258960|NCT01007838|O3|Outcome|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258961|NCT01007838|O2|Outcome|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258962|NCT01007838|O1|Outcome|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258963|NCT01007838|E4|Reported Event|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258964|NCT01007838|E3|Reported Event|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258965|NCT01007838|E2|Reported Event|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
258966|NCT01007838|E1|Reported Event|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
258967|NCT01007812|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
258968|NCT01007812|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
258969|NCT01007812|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
258970|NCT01007812|O2|Outcome|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
258971|NCT01007812|O1|Outcome|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
258972|NCT01007812|E2|Reported Event|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
258973|NCT01007812|E1|Reported Event|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
258974|NCT01007656|B1|Baseline|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258975|NCT01007656|P1|Participant Flow|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258976|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258977|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258978|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258979|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258980|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258981|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258982|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258983|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258984|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258985|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258986|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258987|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258988|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258989|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258990|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258991|NCT01007656|E1|Reported Event|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
258992|NCT01007643|B3|Baseline|Total|Total of all reporting groups
258993|NCT01007643|B2|Baseline|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
258994|NCT01007643|B1|Baseline|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
258995|NCT01007643|P2|Participant Flow|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
259033|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
264025|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
258996|NCT01007643|P1|Participant Flow|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
258997|NCT01007643|O2|Outcome|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
258998|NCT01007643|O1|Outcome|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
258999|NCT01007643|E2|Reported Event|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
259000|NCT01007643|E1|Reported Event|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
259001|NCT01007435|B5|Baseline|Total|Total of all reporting groups
259002|NCT01007435|B4|Baseline|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259003|NCT01007435|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259004|NCT01007435|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259005|NCT01007435|B1|Baseline|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259006|NCT01007435|P4|Participant Flow|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259007|NCT01007435|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259008|NCT01007435|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259009|NCT01007435|P1|Participant Flow|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259010|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259011|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259012|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259013|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259014|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259015|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259016|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259017|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259018|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259019|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259020|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259021|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259022|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259023|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259024|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259025|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259026|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259027|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259028|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259029|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259030|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259031|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
264026|NCT00995930|O1|Outcome|Placebo|SQ monthly
259038|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259039|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259040|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259041|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259042|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259043|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259044|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259045|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259046|NCT01007435|E4|Reported Event|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
259047|NCT01007435|E3|Reported Event|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259048|NCT01007435|E2|Reported Event|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
259049|NCT01007435|E1|Reported Event|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
259050|NCT01007396|B1|Baseline|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
259051|NCT01007396|P1|Participant Flow|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
259052|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
259053|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
259054|NCT01007396|E1|Reported Event|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
259055|NCT01007253|B1|Baseline|Entire Study Population|Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.
259056|NCT01007253|P4|Participant Flow|PL/PL, FF/PL, PL/OLO, FF/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO)."
259057|NCT01007253|P3|Participant Flow|FF/OLO, PL/PL, FF/PL, PL/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)."
259058|NCT01007253|P2|Participant Flow|PL/OLO, FF/OLO, PL/PL, FF/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL), and~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)."
259059|NCT01007253|P1|Participant Flow|FF/PL, PL/OLO, FF/OLO, PL/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and~placebo (PL) nasal spray and PL eye drops (PL/PL)."
259060|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259061|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259062|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259063|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
259064|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259065|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259066|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259067|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
259068|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259069|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259070|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259071|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
259072|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259073|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259078|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259079|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
259080|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259081|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259082|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259083|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
259084|NCT01007253|E4|Reported Event|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259085|NCT01007253|E3|Reported Event|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
259086|NCT01007253|E2|Reported Event|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
259087|NCT01007253|E1|Reported Event|PL/PL|placebo (PL) nasal spray and PL eye drops
259088|NCT01007149|B3|Baseline|Total|Total of all reporting groups
259089|NCT01007149|B2|Baseline|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259090|NCT01007149|B1|Baseline|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259091|NCT01007149|P2|Participant Flow|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259092|NCT01007149|P1|Participant Flow|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259093|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259094|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259095|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259096|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259097|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259098|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259099|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259100|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259101|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259102|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259103|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259104|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259105|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259106|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259107|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259108|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259109|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259110|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259111|NCT01007149|E2|Reported Event|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
259112|NCT01007149|E1|Reported Event|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
259113|NCT01007110|B3|Baseline|Total|Total of all reporting groups
259114|NCT01007110|B2|Baseline|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
259115|NCT01007110|B1|Baseline|Placebo|soy/corn oil placebo
259116|NCT01007110|P2|Participant Flow|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
259117|NCT01007110|P1|Participant Flow|Placebo|soy/corn oil placebo
259118|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
259119|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
259120|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
259121|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
259122|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
259123|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
259124|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
259125|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
259126|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid (DHA)
259127|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
259128|NCT01007110|E2|Reported Event|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
259129|NCT01007110|E1|Reported Event|Placebo|soy/corn oil placebo
259130|NCT01006980|B3|Baseline|Total|Total of all reporting groups
259131|NCT01006980|B2|Baseline|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259359|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259132|NCT01006980|B1|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259133|NCT01006980|P2|Participant Flow|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259134|NCT01006980|P1|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259135|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259136|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259137|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259138|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259139|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259140|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259141|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259142|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259143|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259144|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259145|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259146|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259147|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259148|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
259149|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
259150|NCT01006980|E3|Reported Event|Vemurafenib After Crossover|Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
259151|NCT01006980|E2|Reported Event|Dacarbazine|"Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch.~Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length)."
259152|NCT01006980|E1|Reported Event|Vemurafenib|"Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit.~Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg)."
259153|NCT01006889|B1|Baseline|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
259154|NCT01006889|P1|Participant Flow|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
259155|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259156|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259157|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259158|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259159|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259160|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259161|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
259162|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
259163|NCT01006889|E1|Reported Event|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
259164|NCT01006655|B3|Baseline|Total|Total of all reporting groups
259165|NCT01006655|B2|Baseline|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
259166|NCT01006655|B1|Baseline|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
259167|NCT01006655|P2|Participant Flow|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
259168|NCT01006655|P1|Participant Flow|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
259169|NCT01006655|O2|Outcome|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
259170|NCT01006655|O1|Outcome|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
259171|NCT01006655|E2|Reported Event|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
259172|NCT01006655|E1|Reported Event|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
259173|NCT01006629|B1|Baseline|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259174|NCT01006629|P1|Participant Flow|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259175|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259176|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259177|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259178|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259179|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259180|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259181|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259182|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259183|NCT01006629|E1|Reported Event|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
259184|NCT01006616|B5|Baseline|Total|Total of all reporting groups
259185|NCT01006616|B4|Baseline|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259186|NCT01006616|B3|Baseline|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259187|NCT01006616|B2|Baseline|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259188|NCT01006616|B1|Baseline|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259189|NCT01006616|P4|Participant Flow|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259190|NCT01006616|P3|Participant Flow|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
264027|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
259191|NCT01006616|P2|Participant Flow|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259192|NCT01006616|P1|Participant Flow|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
259193|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259194|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259195|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259196|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259197|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259198|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259199|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259200|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259201|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259202|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259203|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259204|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259205|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259206|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259207|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259208|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259209|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259210|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259211|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259212|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259213|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259214|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259215|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259216|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259217|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259218|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259219|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259220|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259221|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259222|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259223|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259224|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259225|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259226|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259227|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259228|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259229|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
264028|NCT00995930|O1|Outcome|Placebo|SQ monthly
259230|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259231|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259232|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259233|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259234|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259235|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259236|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259237|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259238|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259239|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259240|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259241|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259242|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259243|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259244|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259245|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259246|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259247|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259248|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259249|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259250|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259251|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259252|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259253|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259254|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259255|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259256|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259257|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259258|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259259|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259260|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259261|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259262|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259263|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259264|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259265|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259266|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259267|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259268|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
264029|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
259269|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259270|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259271|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259272|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259273|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259274|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259275|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259276|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259277|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259278|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259279|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259280|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259281|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259282|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259283|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259284|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259285|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259286|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259287|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259288|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259289|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259290|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259291|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259292|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259293|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259294|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259295|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259296|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259297|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259298|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259299|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259300|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259301|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259302|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259303|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259304|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259305|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259306|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259307|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259360|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259308|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259309|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259310|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259311|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259312|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259313|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259314|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259315|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259316|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259317|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259318|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259319|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259320|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259321|NCT01006616|E4|Reported Event|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
259322|NCT01006616|E3|Reported Event|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
259323|NCT01006616|E2|Reported Event|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259324|NCT01006616|E1|Reported Event|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
259325|NCT01006603|B3|Baseline|Total|Total of all reporting groups
259326|NCT01006603|B2|Baseline|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259327|NCT01006603|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259328|NCT01006603|P2|Participant Flow|Glimepiride 1 - 6 mg|Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259329|NCT01006603|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259330|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259331|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259332|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259333|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259334|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259335|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259336|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259337|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259338|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259339|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259340|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259341|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259342|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259343|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259344|NCT01006603|E2|Reported Event|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
259345|NCT01006603|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
259346|NCT01006590|B3|Baseline|Total|Total of all reporting groups
259347|NCT01006590|B2|Baseline|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259348|NCT01006590|B1|Baseline|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259349|NCT01006590|P2|Participant Flow|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259350|NCT01006590|P1|Participant Flow|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259351|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259352|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259353|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259354|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259355|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259356|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259357|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259358|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259361|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259362|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259363|NCT01006590|E2|Reported Event|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
259364|NCT01006590|E1|Reported Event|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
259365|NCT01006356|B1|Baseline|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259366|NCT01006356|P1|Participant Flow|Hydromorphone Hydrochloride Oral Osmotic System|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259367|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259368|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259369|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259370|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259371|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259372|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259373|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259374|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259375|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259376|NCT01006356|E1|Reported Event|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
259377|NCT01006291|B4|Baseline|Total|Total of all reporting groups
259378|NCT01006291|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259379|NCT01006291|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259380|NCT01006291|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259381|NCT01006291|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259382|NCT01006291|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259383|NCT01006291|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259384|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259385|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259386|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259387|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259388|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259389|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259390|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259391|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259392|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259393|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259394|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259395|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259396|NCT01006291|E3|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
259397|NCT01006291|E2|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
259398|NCT01006291|E1|Reported Event|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
259399|NCT01006135|B1|Baseline|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259400|NCT01006135|P1|Participant Flow|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259401|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259402|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259403|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259404|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259405|NCT01006135|E1|Reported Event|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
259406|NCT01006122|B1|Baseline|Entire Study|Included all participants randomized to receive PF-03654746 first and placebo first.
259407|NCT01006122|P2|Participant Flow|Placebo First Then, PF-03654746|Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
259408|NCT01006122|P1|Participant Flow|PF-03654746 First, Then Placebo|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
259409|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259410|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259411|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259412|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259413|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259414|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259415|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259416|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259417|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259418|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259419|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259420|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259421|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259422|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259423|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259424|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259425|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259456|NCT01006018|E2|Reported Event|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
260081|NCT01004510|O1|Outcome|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
259426|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259427|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259428|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259429|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259430|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259431|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259432|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259433|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259434|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259435|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259436|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259437|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259438|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259439|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259440|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259441|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259442|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259443|NCT01006122|E2|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
259444|NCT01006122|E1|Reported Event|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
259445|NCT01006018|B4|Baseline|Total|Total of all reporting groups
259446|NCT01006018|B3|Baseline|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
259447|NCT01006018|B2|Baseline|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
259448|NCT01006018|B1|Baseline|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
259449|NCT01006018|P3|Participant Flow|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
259450|NCT01006018|P2|Participant Flow|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
259451|NCT01006018|P1|Participant Flow|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
259452|NCT01006018|O3|Outcome|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
259453|NCT01006018|O2|Outcome|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
259454|NCT01006018|O1|Outcome|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
259455|NCT01006018|E3|Reported Event|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
259457|NCT01006018|E1|Reported Event|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
259458|NCT01005966|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
259459|NCT01005966|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Placebo fluoride free toothpaste
259460|NCT01005966|P4|Participant Flow|NaF Toothpaste (675ppmF)|Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)
259461|NCT01005966|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
259462|NCT01005966|P2|Participant Flow|Amine Fluoride(AmF) Toothpaste (1400ppmF)|Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)
259463|NCT01005966|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]|Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)
259464|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo: Fluoride free toothpaste
259465|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
259466|NCT01005966|O3|Outcome|Na MFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
259467|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
259468|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
259469|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo - fluoride free toothpaste
259470|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/silica (675ppmF)
259471|NCT01005966|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF– 1000ppmF as NaMFP and 450ppmF as NaF)
259472|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF(1400ppmF)
259473|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
259474|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
259475|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
259476|NCT01005966|E6|Reported Event|Overall|
259477|NCT01005966|E5|Reported Event|Placebo Toothpaste (0ppmF)|Placebo: fluoride free toothpaste
259478|NCT01005966|E4|Reported Event|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
259479|NCT01005966|E3|Reported Event|NaMFP/ NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/ NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
259480|NCT01005966|E2|Reported Event|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
259481|NCT01005966|E1|Reported Event|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
259482|NCT01005914|B1|Baseline|Group 1|"Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily~Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
259483|NCT01005914|P1|Participant Flow|Group 1|"Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
259484|NCT01005914|O1|Outcome|Group 1|Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
259485|NCT01005914|E1|Reported Event|Group 1|"cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
259486|NCT01005901|B3|Baseline|Total|Total of all reporting groups
259487|NCT01005901|B2|Baseline|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259488|NCT01005901|B1|Baseline|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259489|NCT01005901|P2|Participant Flow|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259490|NCT01005901|P1|Participant Flow|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259491|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259492|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259493|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259494|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259495|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259496|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259497|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259498|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259499|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259500|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259501|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259502|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259503|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259504|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259505|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259506|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259507|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259508|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259509|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259510|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259511|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259512|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259546|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259513|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259514|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259515|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259516|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259517|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259518|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259519|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259520|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259521|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259522|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259523|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259524|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259525|NCT01005901|E2|Reported Event|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259526|NCT01005901|E1|Reported Event|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
259527|NCT01005888|B5|Baseline|Total|Total of all reporting groups
259528|NCT01005888|B4|Baseline|Randomized, Not Treated|One subject was randomized but withdrew prior to receiving study drug.
259529|NCT01005888|B3|Baseline|Open-label C1INH-nf Only|One subject received open-label C1INH-nf but withdrew prior to randomization.
259530|NCT01005888|B2|Baseline|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
259531|NCT01005888|B1|Baseline|C1INH-nf First, Then Placebo|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
259532|NCT01005888|P2|Participant Flow|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
259533|NCT01005888|P1|Participant Flow|C1INH-nf First, Then Placebo|1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
259534|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259535|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259536|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259537|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259538|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259539|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259540|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259541|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259542|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259543|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259544|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259545|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
260082|NCT01004510|E1|Reported Event|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
259547|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259548|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259549|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
259550|NCT01005888|E2|Reported Event|Placebo|
259551|NCT01005888|E1|Reported Event|C1INH-nf|
259552|NCT01005875|B1|Baseline|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259553|NCT01005875|P1|Participant Flow|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259554|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259555|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259556|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259557|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259558|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259559|NCT01005875|E1|Reported Event|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
259560|NCT01005745|B1|Baseline|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
259561|NCT01005745|P1|Participant Flow|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
259562|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
259563|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
259564|NCT01005745|E1|Reported Event|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
259592|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
260252|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
259565|NCT01005732|B1|Baseline|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
259566|NCT01005732|P1|Participant Flow|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
259567|NCT01005732|O1|Outcome|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
259568|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259569|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259570|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259571|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259572|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259573|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259574|NCT01005732|O4|Outcome|Uninjured Forearm Skin|Hardness of uninjured forearm skin is provided for comparison.
259575|NCT01005732|O3|Outcome|Kneecap|Hardness of uninjured skin over a bony prominence is provided for comparison.
259576|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259577|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259578|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259579|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
259580|NCT01005732|E1|Reported Event|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
259581|NCT01005719|B1|Baseline|Overall Study|
259582|NCT01005719|P6|Participant Flow|No Treatment-Prevacid®-Zegerid|Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
259583|NCT01005719|P5|Participant Flow|No Treatment-Zegerid-Prevacid®|Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
259584|NCT01005719|P4|Participant Flow|Prevacid®-No Treatment-Zegerid|Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
259585|NCT01005719|P3|Participant Flow|Prevacid®-Zegerid-No Treatment|Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
259586|NCT01005719|P2|Participant Flow|Zegerid-No Treatment-Prevacid®|Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
259587|NCT01005719|P1|Participant Flow|Zegerid-Prevacid®-No Treatment|Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
259588|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving in Prevacid® Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259589|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259590|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259591|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
260253|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
259593|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259594|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259595|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259596|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259597|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259598|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259599|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259600|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259601|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259602|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259603|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259604|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259605|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259606|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259607|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259608|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259609|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259610|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259611|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259612|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259613|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259614|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259615|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
260254|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260255|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
259616|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259617|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259618|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259619|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259620|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259621|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259622|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259623|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259624|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259625|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259626|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259627|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259628|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259629|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259630|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259631|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259632|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259633|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259634|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259635|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259636|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259637|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259638|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259832|NCT01004848|P2|Participant Flow|Delayed Intervention|The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259639|NCT01005719|E3|Reported Event|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259640|NCT01005719|E2|Reported Event|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259641|NCT01005719|E1|Reported Event|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
259642|NCT01005706|B3|Baseline|Total|Total of all reporting groups
259643|NCT01005706|B2|Baseline|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
259644|NCT01005706|B1|Baseline|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
259645|NCT01005706|P2|Participant Flow|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
259646|NCT01005706|P1|Participant Flow|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
259647|NCT01005706|O2|Outcome|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
259648|NCT01005706|O1|Outcome|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
259649|NCT01005706|E2|Reported Event|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
259650|NCT01005706|E1|Reported Event|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
259651|NCT01005680|B3|Baseline|Total|Total of all reporting groups
259652|NCT01005680|B2|Baseline|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
259653|NCT01005680|B1|Baseline|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
259654|NCT01005680|P2|Participant Flow|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259655|NCT01005680|P1|Participant Flow|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259656|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259657|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259883|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259658|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259659|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259660|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259661|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259662|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259663|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259664|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259665|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259666|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259667|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259668|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259669|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259670|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259671|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259672|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259673|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
259674|NCT01005680|E2|Reported Event|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
259675|NCT01005680|E1|Reported Event|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
259676|NCT01005602|B3|Baseline|Total|Total of all reporting groups
259677|NCT01005602|B2|Baseline|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
259678|NCT01005602|B1|Baseline|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259679|NCT01005602|P2|Participant Flow|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
259680|NCT01005602|P1|Participant Flow|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259681|NCT01005602|O4|Outcome|GA Genotype|
259682|NCT01005602|O3|Outcome|TT Genotype|
259683|NCT01005602|O2|Outcome|GT Genotype|
259684|NCT01005602|O1|Outcome|Wild Type (GG)|
259685|NCT01005602|O3|Outcome|TT Genotype|
259686|NCT01005602|O2|Outcome|CT Genotype|
259687|NCT01005602|O1|Outcome|Wild Type (CC)|
259688|NCT01005602|O3|Outcome|TT Genotype|
259689|NCT01005602|O2|Outcome|CT Genotype|
259690|NCT01005602|O1|Outcome|Wild Type|Genotypes for the ABCB1 single nucleotide polymorphism C1236T
259691|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
260256|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
259692|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259693|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
259694|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259695|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
259696|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259697|NCT01005602|E2|Reported Event|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
259698|NCT01005602|E1|Reported Event|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
259699|NCT01005355|B4|Baseline|Total|Total of all reporting groups
259700|NCT01005355|B3|Baseline|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259701|NCT01005355|B2|Baseline|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259702|NCT01005355|B1|Baseline|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259703|NCT01005355|P3|Participant Flow|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259704|NCT01005355|P2|Participant Flow|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259705|NCT01005355|P1|Participant Flow|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259706|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259707|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259708|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259709|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259710|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259711|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259712|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259713|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259714|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259715|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259716|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259717|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259718|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259719|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259720|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259721|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259722|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259723|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259724|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259884|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
260257|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
259725|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259726|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259727|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259728|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259729|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259730|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259731|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259732|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259733|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259734|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259735|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259736|NCT01005355|E3|Reported Event|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259737|NCT01005355|E2|Reported Event|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259738|NCT01005355|E1|Reported Event|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
259739|NCT01005329|B1|Baseline|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
264030|NCT00995930|O1|Outcome|Placebo|SQ monthly
259740|NCT01005329|P1|Participant Flow|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
259741|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
259742|NCT01005329|E1|Reported Event|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
259743|NCT01005290|B1|Baseline|Randomized Patiens|All patients who were randomized to both treatment sequences
259744|NCT01005290|P3|Participant Flow|Ramipril Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
259745|NCT01005290|P2|Participant Flow|Combination Pill Then Ramipril|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
259746|NCT01005290|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg once daily
259747|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
259748|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
259749|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
259750|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
259751|NCT01005290|E2|Reported Event|Ramipril|
259752|NCT01005290|E1|Reported Event|Combination Pill|
259753|NCT01005251|B6|Baseline|Total|Total of all reporting groups
259754|NCT01005251|B5|Baseline|Placebo|PPI+Placebo
259755|NCT01005251|B4|Baseline|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
259756|NCT01005251|B3|Baseline|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
259757|NCT01005251|B2|Baseline|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
259758|NCT01005251|B1|Baseline|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
259759|NCT01005251|P5|Participant Flow|Placebo|PPI+Placebo
259760|NCT01005251|P4|Participant Flow|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
259761|NCT01005251|P3|Participant Flow|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
259762|NCT01005251|P2|Participant Flow|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
259763|NCT01005251|P1|Participant Flow|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
259764|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
259765|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
259766|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
259767|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
259768|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
259769|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
259770|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
259771|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
259772|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
259773|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
259774|NCT01005251|E5|Reported Event|Placebo|PPI+Placebo
259775|NCT01005251|E4|Reported Event|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
259776|NCT01005251|E3|Reported Event|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
259777|NCT01005251|E2|Reported Event|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
259778|NCT01005251|E1|Reported Event|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
259779|NCT01004939|B1|Baseline|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259780|NCT01004939|P1|Participant Flow|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259781|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259782|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259783|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259784|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259785|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259786|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259787|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259788|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259789|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259790|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259791|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259792|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259793|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259794|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259795|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259796|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259797|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259798|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259799|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259800|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259801|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259802|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259803|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259804|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
259805|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259806|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259807|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259808|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259809|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259810|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259811|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259812|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259813|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259814|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259815|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
260258|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
259816|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259817|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
259818|NCT01004939|E2|Reported Event|Fondaparinux - Child|Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
259819|NCT01004939|E1|Reported Event|Fondaparinux - Mother|Events reported for mothers receiving Fondaparinux
259820|NCT01004874|B1|Baseline|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259821|NCT01004874|P1|Participant Flow|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259822|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259823|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259824|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259825|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259826|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259827|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259828|NCT01004874|E1|Reported Event|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
259829|NCT01004848|B3|Baseline|Total|Total of all reporting groups
259830|NCT01004848|B2|Baseline|Delayed Intervention|The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259831|NCT01004848|B1|Baseline|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes."
260259|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
264031|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
259833|NCT01004848|P1|Participant Flow|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259834|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259835|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259836|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259837|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259838|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259839|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259840|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259841|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259842|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259843|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259844|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259845|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259846|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259847|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259848|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259849|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259850|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259851|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259852|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259853|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259854|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259885|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259855|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259856|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259857|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259858|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259859|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259860|NCT01004848|E2|Reported Event|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
259861|NCT01004848|E1|Reported Event|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
259862|NCT01004822|B9|Baseline|Total|Total of all reporting groups
259863|NCT01004822|B8|Baseline|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259864|NCT01004822|B7|Baseline|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259865|NCT01004822|B6|Baseline|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259866|NCT01004822|B5|Baseline|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259867|NCT01004822|B4|Baseline|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259868|NCT01004822|B3|Baseline|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259869|NCT01004822|B2|Baseline|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259870|NCT01004822|B1|Baseline|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259871|NCT01004822|P8|Participant Flow|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259872|NCT01004822|P7|Participant Flow|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259873|NCT01004822|P6|Participant Flow|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259874|NCT01004822|P5|Participant Flow|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259875|NCT01004822|P4|Participant Flow|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259876|NCT01004822|P3|Participant Flow|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259877|NCT01004822|P2|Participant Flow|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259878|NCT01004822|P1|Participant Flow|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259879|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259880|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259881|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259882|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259886|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259887|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259888|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259889|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259890|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259891|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259892|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259893|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259894|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259895|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259896|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259897|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259898|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259899|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259900|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259901|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259902|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259903|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259904|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259905|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259906|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259907|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259908|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259909|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259910|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259911|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259912|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259913|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259914|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259915|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259916|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259917|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259918|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259919|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259920|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259921|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259922|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259923|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259924|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259925|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259926|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259927|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259928|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259929|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259930|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259931|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259932|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259933|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259934|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259935|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259936|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259937|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259938|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259939|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259940|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259941|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259942|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259943|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259944|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259945|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
264032|NCT00995930|O1|Outcome|Placebo|SQ monthly
259946|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259947|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259948|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259949|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259950|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259951|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259952|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259953|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259954|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259955|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259956|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259957|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259958|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259959|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259960|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259961|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259962|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259963|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259964|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259965|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259966|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259967|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259968|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259969|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259970|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259971|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259972|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259973|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259974|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259975|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
264033|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
259976|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259977|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259978|NCT01004822|E8|Reported Event|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259979|NCT01004822|E7|Reported Event|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259980|NCT01004822|E6|Reported Event|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259981|NCT01004822|E5|Reported Event|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259982|NCT01004822|E4|Reported Event|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259983|NCT01004822|E3|Reported Event|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259984|NCT01004822|E2|Reported Event|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259985|NCT01004822|E1|Reported Event|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
259986|NCT01004770|B6|Baseline|Total|Total of all reporting groups
259987|NCT01004770|B5|Baseline|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
259988|NCT01004770|B4|Baseline|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
259989|NCT01004770|B3|Baseline|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
259990|NCT01004770|B2|Baseline|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
259991|NCT01004770|B1|Baseline|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
259992|NCT01004770|P5|Participant Flow|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
259993|NCT01004770|P4|Participant Flow|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
259994|NCT01004770|P3|Participant Flow|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
259995|NCT01004770|P2|Participant Flow|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
259996|NCT01004770|P1|Participant Flow|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
259997|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
259998|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
259999|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260000|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260001|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260002|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
260003|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
260004|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260005|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260006|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260007|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
260008|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
260009|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260010|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260011|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260012|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
260079|NCT01004510|B1|Baseline|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
260013|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
260014|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260015|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260016|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260017|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
260018|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
260019|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260020|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260021|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260022|NCT01004770|E5|Reported Event|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
260023|NCT01004770|E4|Reported Event|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
260024|NCT01004770|E3|Reported Event|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
260025|NCT01004770|E2|Reported Event|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
260026|NCT01004770|E1|Reported Event|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
260027|NCT01004705|B1|Baseline|Randomized Patients|All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
260028|NCT01004705|P3|Participant Flow|Simvastatin Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
260029|NCT01004705|P2|Participant Flow|Combination Pill Then Simvastatin|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks
260030|NCT01004705|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
260031|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
260032|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
260033|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
260034|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
260035|NCT01004705|E3|Reported Event|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
260036|NCT01004705|E2|Reported Event|Combination Pill|Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks
260037|NCT01004705|E1|Reported Event|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
260038|NCT01004614|B5|Baseline|Total|Total of all reporting groups
260039|NCT01004614|B4|Baseline|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
260040|NCT01004614|B3|Baseline|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
260041|NCT01004614|B2|Baseline|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
260042|NCT01004614|B1|Baseline|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
260080|NCT01004510|P1|Participant Flow|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
264034|NCT00995930|O1|Outcome|Placebo|SQ monthly
260043|NCT01004614|P4|Participant Flow|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
260044|NCT01004614|P3|Participant Flow|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
260045|NCT01004614|P2|Participant Flow|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
260046|NCT01004614|P1|Participant Flow|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
260047|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260048|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260049|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260050|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260051|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260052|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260053|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260054|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260055|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260056|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260057|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260058|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260059|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260060|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260061|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260062|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260063|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260064|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260065|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260066|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260067|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260068|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260069|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260070|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260071|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260072|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260073|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260074|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260075|NCT01004614|E4|Reported Event|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
260076|NCT01004614|E3|Reported Event|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
260077|NCT01004614|E2|Reported Event|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
260078|NCT01004614|E1|Reported Event|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
260083|NCT01004432|B1|Baseline|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
260084|NCT01004432|P5|Participant Flow|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
260085|NCT01004432|P4|Participant Flow|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
260086|NCT01004432|P3|Participant Flow|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
260087|NCT01004432|P2|Participant Flow|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
260088|NCT01004432|P1|Participant Flow|Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
260089|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
260090|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
260091|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
260092|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
260093|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
260094|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
260095|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
260096|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
260097|NCT01004432|O2|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
260098|NCT01004432|O1|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
260099|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
260100|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
260101|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
260102|NCT01004432|E5|Reported Event|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
260103|NCT01004432|E4|Reported Event|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
260104|NCT01004432|E3|Reported Event|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
260105|NCT01004432|E2|Reported Event|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
260260|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260106|NCT01004432|E1|Reported Event|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
260107|NCT01004393|B1|Baseline|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260108|NCT01004393|P1|Participant Flow|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260109|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260110|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260111|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260112|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260113|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260114|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260115|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260116|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260117|NCT01004393|E1|Reported Event|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
260118|NCT01004354|B1|Baseline|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
260119|NCT01004354|P1|Participant Flow|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
260120|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
260121|NCT01004354|E1|Reported Event|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
260122|NCT01004263|B1|Baseline|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260123|NCT01004263|P1|Participant Flow|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260124|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260125|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260126|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260127|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260128|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260261|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
264035|NCT00995930|E2|Reported Event|Placebo|SQ monthly
260129|NCT01004263|E1|Reported Event|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
260130|NCT01004250|B1|Baseline|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260131|NCT01004250|P1|Participant Flow|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260132|NCT01004250|O1|Outcome|Study Treament|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260133|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
260134|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260135|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260136|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260137|NCT01004250|E3|Reported Event|Overall Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260138|NCT01004250|E2|Reported Event|Maintenance Therapy|"Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
260139|NCT01004250|E1|Reported Event|Induction Therapy|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
260140|NCT01004185|B3|Baseline|Total|Total of all reporting groups
260141|NCT01004185|B2|Baseline|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
260142|NCT01004185|B1|Baseline|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
260143|NCT01004185|P2|Participant Flow|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
260144|NCT01004185|P1|Participant Flow|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
260145|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
260146|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
260147|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
260148|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
260149|NCT01004185|E2|Reported Event|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
260150|NCT01004185|E1|Reported Event|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
260151|NCT01004159|B1|Baseline|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
260152|NCT01004159|P1|Participant Flow|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
260153|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
260154|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
260155|NCT01004159|E1|Reported Event|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
260156|NCT01004146|B3|Baseline|Total|Total of all reporting groups
260157|NCT01004146|B2|Baseline|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
260158|NCT01004146|B1|Baseline|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
260159|NCT01004146|P2|Participant Flow|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
260160|NCT01004146|P1|Participant Flow|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
260161|NCT01004146|O2|Outcome|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
260162|NCT01004146|O1|Outcome|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
260163|NCT01004146|E2|Reported Event|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
260164|NCT01004146|E1|Reported Event|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
260165|NCT01004003|B10|Baseline|Total|Total of all reporting groups
260166|NCT01004003|B9|Baseline|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260167|NCT01004003|B8|Baseline|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260168|NCT01004003|B7|Baseline|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260169|NCT01004003|B6|Baseline|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260170|NCT01004003|B5|Baseline|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260171|NCT01004003|B4|Baseline|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260172|NCT01004003|B3|Baseline|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260262|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260173|NCT01004003|B2|Baseline|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260174|NCT01004003|B1|Baseline|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
260175|NCT01004003|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260176|NCT01004003|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260177|NCT01004003|P7|Participant Flow|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260178|NCT01004003|P6|Participant Flow|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260179|NCT01004003|P5|Participant Flow|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260180|NCT01004003|P4|Participant Flow|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260181|NCT01004003|P3|Participant Flow|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260182|NCT01004003|P2|Participant Flow|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260183|NCT01004003|P1|Participant Flow|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
260184|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260185|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260186|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260187|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260188|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260189|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260190|NCT01004003|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
260263|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
264036|NCT00995930|E1|Reported Event|ACZ885 150mg|ACZ885 150mg
260191|NCT01004003|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
260192|NCT01004003|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
260193|NCT01004003|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
260194|NCT01004003|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
260195|NCT01004003|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
260196|NCT01004003|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).~Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN)."
260197|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260198|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260199|NCT01004003|O2|Outcome|Group 2|Patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260200|NCT01004003|O1|Outcome|Group 1|Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
260201|NCT01004003|E9|Reported Event|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260202|NCT01004003|E8|Reported Event|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260203|NCT01004003|E7|Reported Event|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260204|NCT01004003|E6|Reported Event|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260205|NCT01004003|E5|Reported Event|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260206|NCT01004003|E4|Reported Event|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
260207|NCT01004003|E3|Reported Event|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260208|NCT01004003|E2|Reported Event|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
260209|NCT01004003|E1|Reported Event|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
260210|NCT01003938|B1|Baseline|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260211|NCT01003938|P1|Participant Flow|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260264|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260212|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260213|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260214|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260215|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260216|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260217|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260218|NCT01003938|E1|Reported Event|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
260219|NCT01003899|B1|Baseline|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260220|NCT01003899|P1|Participant Flow|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260221|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260222|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260223|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260224|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260225|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260226|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260227|NCT01003899|E1|Reported Event|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
260228|NCT01003886|B1|Baseline|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260229|NCT01003886|P1|Participant Flow|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260230|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260231|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260232|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260233|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260234|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260235|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260236|NCT01003886|E1|Reported Event|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
260237|NCT01002742|B3|Baseline|Total|Total of all reporting groups
260238|NCT01002742|B2|Baseline|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260239|NCT01002742|B1|Baseline|Placebo|Corticosteroids with placebo
260240|NCT01002742|P2|Participant Flow|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260241|NCT01002742|P1|Participant Flow|Placebo|Corticosteroids with placebo
260242|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260243|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260244|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260245|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260246|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260247|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260248|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260249|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260250|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260251|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260266|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260267|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260268|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260269|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260270|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260271|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
260272|NCT01002742|E2|Reported Event|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
260273|NCT01002742|E1|Reported Event|Placebo|Corticosteroids with placebo
260274|NCT01003301|B3|Baseline|Total|Total of all reporting groups
260275|NCT01003301|B2|Baseline|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260276|NCT01003301|B1|Baseline|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260277|NCT01003301|P2|Participant Flow|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260278|NCT01003301|P1|Participant Flow|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260279|NCT01003301|O2|Outcome|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260280|NCT01003301|O1|Outcome|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260281|NCT01003301|E2|Reported Event|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260282|NCT01003301|E1|Reported Event|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
260283|NCT01003288|B3|Baseline|Total|Total of all reporting groups
260284|NCT01003288|B2|Baseline|Hypogammaglobulinaemic Patients|Received two doses of pandemic vaccine
260285|NCT01003288|B1|Baseline|Health Care Workers|Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
260286|NCT01003288|P1|Participant Flow|Pandemic Influenza Vaccine (H1N1)v|"Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)~* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
260287|NCT01003288|O1|Outcome|HCW Pandemic Vaccine|
260288|NCT01003288|O1|Outcome|Pandemic Vaccine|Pandemic Vaccine in HCW
260289|NCT01003288|E1|Reported Event|Pandemic Vaccine|HCW vaccinated with pandemic vaccine
260290|NCT01003275|B3|Baseline|Total|Total of all reporting groups
260291|NCT01003275|B2|Baseline|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
260292|NCT01003275|B1|Baseline|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
260293|NCT01003275|P2|Participant Flow|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
260294|NCT01003275|P1|Participant Flow|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
260295|NCT01003275|O2|Outcome|During Placebo Treatment|
260296|NCT01003275|O1|Outcome|During Paricalcitol Treatment|
260297|NCT01003275|E2|Reported Event|During/After Placebo|
260298|NCT01003275|E1|Reported Event|During/After Paricalcitol|
260299|NCT01003210|B3|Baseline|Total|Total of all reporting groups
260300|NCT01003210|B2|Baseline|Standard Therapy|standard therapy for otitis media, no ear drops
260301|NCT01003210|B1|Baseline|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
260302|NCT01003210|P2|Participant Flow|Standard Therapy|standard therapy for otitis media, no ear drops
260303|NCT01003210|P1|Participant Flow|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
260304|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
260305|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
260306|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
260307|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
260308|NCT01003210|E2|Reported Event|Standard Therapy|standard therapy for otitis media, no ear drops
260309|NCT01003210|E1|Reported Event|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
260310|NCT01003184|B3|Baseline|Total|Total of all reporting groups
260311|NCT01003184|B2|Baseline|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260312|NCT01003184|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260313|NCT01003184|P2|Participant Flow|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260314|NCT01003184|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260315|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260316|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260317|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260318|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260319|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260320|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260321|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260322|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260323|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260324|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260325|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260326|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260327|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260328|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260329|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260330|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260331|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260332|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260333|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260334|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260335|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260336|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260337|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260338|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260339|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260340|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260341|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260342|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260343|NCT01003184|E2|Reported Event|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
260344|NCT01003184|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
260345|NCT01003106|B5|Baseline|Total|Total of all reporting groups
260346|NCT01003106|B4|Baseline|CRVO- Ranibizumab 2.0mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
260619|NCT01001767|E1|Reported Event|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
260347|NCT01003106|B3|Baseline|CRVO- Ranibizumab 0.5mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation~CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
260348|NCT01003106|B2|Baseline|BRVO- Ranibizumab 2.0mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
260349|NCT01003106|B1|Baseline|BRVO- Ranibizumab 0.5mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
260350|NCT01003106|P8|Participant Flow|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
260351|NCT01003106|P7|Participant Flow|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
260352|NCT01003106|P6|Participant Flow|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
260353|NCT01003106|P5|Participant Flow|CRVO- Ranibizumab 0.5mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
260354|NCT01003106|P4|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
260355|NCT01003106|P3|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
260356|NCT01003106|P2|Participant Flow|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
260357|NCT01003106|P1|Participant Flow|BRVO- Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
260358|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
260359|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
260360|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
260361|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
260362|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
260363|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
260364|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
260365|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
260366|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
260367|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
260368|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
260369|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
260370|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
260371|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
260372|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
260373|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
260374|NCT01003106|O2|Outcome|CRVO|Patients with Central Retinal Vein Occlusion
260375|NCT01003106|O1|Outcome|BRVO|Patients with Branch Retinal Vein Occlusion
260376|NCT01003106|E2|Reported Event|CRVO|Patients with Central Retinal Vein Occlusion
260377|NCT01003106|E1|Reported Event|BRVO|Patients with Branch Retinal Vein Occlusion
260378|NCT01003080|B3|Baseline|Total|Total of all reporting groups
260379|NCT01003080|B2|Baseline|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
260380|NCT01003080|B1|Baseline|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
260381|NCT01003080|P2|Participant Flow|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
260382|NCT01003080|P1|Participant Flow|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
260383|NCT01003080|O2|Outcome|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
260664|NCT01001546|B3|Baseline|Total|Total of all reporting groups
260384|NCT01003080|O1|Outcome|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
260385|NCT01003080|E2|Reported Event|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
260386|NCT01003080|E1|Reported Event|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
260387|NCT01002989|B1|Baseline|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260388|NCT01002989|P1|Participant Flow|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260389|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260390|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260391|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260392|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260393|NCT01002989|E1|Reported Event|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
260394|NCT01002573|B3|Baseline|Total|Total of all reporting groups
260395|NCT01002573|B2|Baseline|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260396|NCT01002573|B1|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260397|NCT01002573|P2|Participant Flow|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260398|NCT01002573|P1|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260399|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260400|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260401|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260402|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260403|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260404|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260405|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260406|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260407|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260408|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260409|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260410|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260411|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260412|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260413|NCT01002573|E2|Reported Event|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
260414|NCT01002573|E1|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
260415|NCT01002482|B3|Baseline|Total|Total of all reporting groups
260416|NCT01002482|B2|Baseline|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260417|NCT01002482|B1|Baseline|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260418|NCT01002482|P2|Participant Flow|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260419|NCT01002482|P1|Participant Flow|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260420|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260421|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260422|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260423|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260424|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260425|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260426|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260427|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260428|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260429|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260430|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260431|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260432|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260433|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260434|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260435|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260436|NCT01002482|E2|Reported Event|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
260437|NCT01002482|E1|Reported Event|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
260438|NCT01002456|B3|Baseline|Total|Total of all reporting groups
260439|NCT01002456|B2|Baseline|Level 2|site- and patient-specific information provided
260440|NCT01002456|B1|Baseline|Level 1|site-specific information provided
260441|NCT01002456|P2|Participant Flow|Arm 2|"provide site- and patient-specific information~Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions"
260442|NCT01002456|P1|Participant Flow|Arm 1|"provide site-specific information~Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline"
260443|NCT01002456|O2|Outcome|Level 2:Provide Site- and Patient-specific Information|Level 2:provide site- and patient-specific information on nonadherence
260444|NCT01002456|O1|Outcome|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on nonadherence
260445|NCT01002456|O2|Outcome|Level 2|provide site- and patient-specific information
260446|NCT01002456|O1|Outcome|Level 1|provide site-specific information
260447|NCT01002456|E2|Reported Event|Level 2: Provide Site- and Patient-specific Information|Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
260448|NCT01002456|E1|Reported Event|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on non-adherence
260449|NCT01002339|B4|Baseline|Total|Total of all reporting groups
260450|NCT01002339|B3|Baseline|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260451|NCT01002339|B2|Baseline|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260452|NCT01002339|B1|Baseline|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260453|NCT01002339|P3|Participant Flow|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260454|NCT01002339|P2|Participant Flow|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260455|NCT01002339|P1|Participant Flow|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260456|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260457|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260458|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260459|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260460|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260461|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260462|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260463|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260464|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260465|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260466|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260467|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260468|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260469|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260470|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260608|NCT01001806|E3|Reported Event|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
265870|NCT00990769|B3|Baseline|Total|Total of all reporting groups
260471|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260472|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260473|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260474|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260475|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260476|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260477|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260478|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260479|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260480|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260481|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260482|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260483|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260484|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260485|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260609|NCT01001806|E2|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
260486|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260487|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260488|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260489|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260490|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260491|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260492|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260493|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260494|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260495|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260496|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260497|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260498|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260499|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260500|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260610|NCT01001806|E1|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
260501|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260502|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260503|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260504|NCT01002339|E3|Reported Event|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
260505|NCT01002339|E2|Reported Event|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
260506|NCT01002339|E1|Reported Event|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
260507|NCT01002287|B3|Baseline|Total|Total of all reporting groups
260508|NCT01002287|B2|Baseline|Control|Good Surgical Technique Alone
260509|NCT01002287|B1|Baseline|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
260510|NCT01002287|P2|Participant Flow|Control|Good Surgical Technique Alone
260511|NCT01002287|P1|Participant Flow|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
260512|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
260513|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
260514|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
260515|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
260516|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
260517|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
260518|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
260519|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
260520|NCT01002287|E2|Reported Event|Control|Good Surgical Technique Alone
260521|NCT01002287|E1|Reported Event|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
260522|NCT01002105|B3|Baseline|Total|Total of all reporting groups
260523|NCT01002105|B2|Baseline|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260524|NCT01002105|B1|Baseline|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
260525|NCT01002105|P2|Participant Flow|Placebo|Placebo, identical to baclofen was administered to the placebo group for 12 weeks
260526|NCT01002105|P1|Participant Flow|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
260527|NCT01002105|O2|Outcome|Placebo|IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
260528|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
260529|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260530|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
260531|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260532|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
260533|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260611|NCT01001767|B3|Baseline|Total|Total of all reporting groups
271382|NCT00975637|P4|Participant Flow|Placebo|Placebo: Placebo SC
260534|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
260535|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260536|NCT01002105|O1|Outcome|Baclofen|The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Baclofen: Baclofen 50mg per day for 12 weeks
260537|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
260538|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
260539|NCT01002105|E2|Reported Event|Placebo|The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
260540|NCT01002105|E1|Reported Event|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
260541|NCT01001975|B3|Baseline|Total|Total of all reporting groups
260542|NCT01001975|B2|Baseline|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
260543|NCT01001975|B1|Baseline|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
260544|NCT01001975|P2|Participant Flow|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
260545|NCT01001975|P1|Participant Flow|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
260546|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
260547|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
260548|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
260549|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
260550|NCT01001975|E2|Reported Event|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
260551|NCT01001975|E1|Reported Event|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
260552|NCT01001832|B3|Baseline|Total|Total of all reporting groups
260553|NCT01001832|B2|Baseline|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260554|NCT01001832|B1|Baseline|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260555|NCT01001832|P2|Participant Flow|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260556|NCT01001832|P1|Participant Flow|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260612|NCT01001767|B2|Baseline|Placebo|Placebo capsule by mouth twice a day x 24 weeks
260613|NCT01001767|B1|Baseline|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
260614|NCT01001767|P2|Participant Flow|Placebo|Placebo capsule by mouth twice a day x 24 weeks
260557|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260558|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260559|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260560|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260561|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260562|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260563|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260564|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260565|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260566|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260567|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260568|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260569|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260570|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260615|NCT01001767|P1|Participant Flow|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
260616|NCT01001767|O2|Outcome|Placebo|Placebo capsule by mouth twice a day x 24 weeks
260571|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260572|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260573|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260574|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260575|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260576|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260577|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260578|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260579|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260580|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260581|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260582|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260583|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260584|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260617|NCT01001767|O1|Outcome|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
260618|NCT01001767|E2|Reported Event|Placebo|Placebo capsule by mouth twice a day x 24 weeks
260585|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260586|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260587|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260588|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260589|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260590|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260591|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260592|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
260593|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
260594|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
260595|NCT01001832|E3|Reported Event|Short Term Subcutaneous (SC) Abatacept, 125 mg|Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
260596|NCT01001832|E2|Reported Event|Short Term Intravenous (IV) Abatacept, 125 mg|Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
260597|NCT01001832|E1|Reported Event|Abatacept Long-term (LT) SC 125 mg|Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
260598|NCT01001806|B4|Baseline|Total|Total of all reporting groups
260599|NCT01001806|B3|Baseline|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
260600|NCT01001806|B2|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
260601|NCT01001806|B1|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
260602|NCT01001806|P3|Participant Flow|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
260603|NCT01001806|P2|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
260604|NCT01001806|P1|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
260605|NCT01001806|O3|Outcome|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
260606|NCT01001806|O2|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
260607|NCT01001806|O1|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
271383|NCT00975637|P3|Participant Flow|Broda 280 mg|AMG 827: 280 mg SC
260620|NCT01001702|B1|Baseline|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260621|NCT01001702|P1|Participant Flow|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260622|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260623|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260624|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260625|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260626|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260627|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260628|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260629|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260630|NCT01001702|E1|Reported Event|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
260631|NCT01001572|B3|Baseline|Total|Total of all reporting groups
260632|NCT01001572|B2|Baseline|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260633|NCT01001572|B1|Baseline|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260634|NCT01001572|P3|Participant Flow|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260635|NCT01001572|P2|Participant Flow|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260636|NCT01001572|P1|Participant Flow|Single-Blind Run -In Valsartan 160 mg|Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
260637|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260638|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260639|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260640|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260641|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260642|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260643|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260644|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260645|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260646|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260647|NCT01001572|E2|Reported Event|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
260648|NCT01001572|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
260649|NCT01001559|B3|Baseline|Total|Total of all reporting groups
260650|NCT01001559|B2|Baseline|Antidepressant Alone|SSRI or SNRI alone
260651|NCT01001559|B1|Baseline|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260652|NCT01001559|P2|Participant Flow|Antidepressant Alone|SSRI or SNRI alone
260653|NCT01001559|P1|Participant Flow|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260654|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
260655|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260656|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
260657|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260658|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
260659|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260660|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
260661|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260662|NCT01001559|E2|Reported Event|Antidepressant Alone|SSRI or SNRI alone
260663|NCT01001559|E1|Reported Event|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
260665|NCT01001546|B2|Baseline|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
260666|NCT01001546|B1|Baseline|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
260667|NCT01001546|P2|Participant Flow|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
260668|NCT01001546|P1|Participant Flow|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
260669|NCT01001546|O2|Outcome|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
260670|NCT01001546|O1|Outcome|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
260671|NCT01001546|E2|Reported Event|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
260672|NCT01001546|E1|Reported Event|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
260673|NCT01001520|B1|Baseline|Entire Study Population|Includes all subjects who were randomized to both study treatment groups (i.e., receive both placebo first and tolcapone first) and initiated study medication.
260674|NCT01001520|P2|Participant Flow|Tolcapone First, Then Placebo|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took tolcapone during the first medication period, followed by a placebo during the second medication period.~During the active tolcapone medication period, subjects followed a tapered dosing schedule (see protocol section for complete description)."
260675|NCT01001520|P1|Participant Flow|Placebo First, Then Tolcapone|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took placebo during the first medication period, followed by tolcapone during the second medication period.~During the placebo medication period, subjects followed a medication regimen and took capsules that were identical to those in the active tolcapone medication period (see protocol section for complete description)."
260676|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260677|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260678|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260679|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260680|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260681|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260682|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260700|NCT01001494|B2|Baseline|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260701|NCT01001494|B1|Baseline|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260702|NCT01001494|P3|Participant Flow|Placebo|Placebo via inhalation
271384|NCT00975637|P2|Participant Flow|Broda 140 mg|AMG 827: 140 mg SC
260683|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260684|NCT01001520|O2|Outcome|Tolcapone|"See Protocol or Participant Flow sections for full description of this study arm."
260685|NCT01001520|O1|Outcome|Placebo|"See Protocol or Participant Flow sections for full description of this study arm."
260686|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260687|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260688|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260689|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260690|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260691|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260692|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260693|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260694|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)"
260695|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
260696|NCT01001520|E2|Reported Event|Tolcapone|"11-day phase, tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily); oral dosing; medication is encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)~Tolcapone: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
260697|NCT01001520|E1|Reported Event|Placebo|"11-day placebo-controlled medication period. Placebo capsules are identical to those in the active tolcapone treatment. When taking placebo, subjects follow an identical dosing schedule as the active treatment period.~Placebo: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
260698|NCT01001494|B4|Baseline|Total|Total of all reporting groups
260699|NCT01001494|B3|Baseline|Placebo|Placebo via inhalation
271385|NCT00975637|P1|Participant Flow|Broda 210 mg|AMG 827: 210 mg SC
260703|NCT01001494|P2|Participant Flow|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260704|NCT01001494|P1|Participant Flow|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260705|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
260706|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260707|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260708|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
260709|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260710|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260711|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
260712|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260713|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260714|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
260715|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260716|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260717|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
260718|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260719|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260720|NCT01001494|E3|Reported Event|Placebo|Placebo via inhalation
260721|NCT01001494|E2|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
260722|NCT01001494|E1|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
260723|NCT01001403|B3|Baseline|Total|Total of all reporting groups
260724|NCT01001403|B2|Baseline|Control|
260725|NCT01001403|B1|Baseline|Nafamostat|
260726|NCT01001403|P2|Participant Flow|Control|
260727|NCT01001403|P1|Participant Flow|Nafamostat|
260728|NCT01001403|O2|Outcome|Control|
260729|NCT01001403|O1|Outcome|Nafamostat|
260730|NCT01001403|E2|Reported Event|Control|
260731|NCT01001403|E1|Reported Event|Nafamostat|
260732|NCT01001390|B1|Baseline|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
260733|NCT01001390|P2|Participant Flow|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
260734|NCT01001390|P1|Participant Flow|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
260735|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
260736|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
260737|NCT01001390|E2|Reported Event|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
260738|NCT01001390|E1|Reported Event|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
260739|NCT01001377|B3|Baseline|Total|Total of all reporting groups
260740|NCT01001377|B2|Baseline|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260741|NCT01001377|B1|Baseline|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260742|NCT01001377|P2|Participant Flow|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260743|NCT01001377|P1|Participant Flow|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260744|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260745|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260746|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260747|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260748|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260749|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260750|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260751|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260752|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260753|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260754|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
271386|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
260755|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260756|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260757|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260758|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260759|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260760|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260761|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260762|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260763|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260764|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260765|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260766|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260767|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260768|NCT01001377|E2|Reported Event|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
260769|NCT01001377|E1|Reported Event|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
260770|NCT01001325|B3|Baseline|Total|Total of all reporting groups
260771|NCT01001325|B2|Baseline|Placebo|0.5 mL normal saline
260772|NCT01001325|B1|Baseline|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
260773|NCT01001325|P2|Participant Flow|Placebo|0.5 mL normal saline
260774|NCT01001325|P1|Participant Flow|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
260775|NCT01001325|O2|Outcome|Placebo|0.5 mL normal saline
260776|NCT01001325|O1|Outcome|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
260777|NCT01001325|E2|Reported Event|Placebo|0.5 mL normal saline
260778|NCT01001325|E1|Reported Event|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
260779|NCT01001299|B1|Baseline|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260780|NCT01001299|P1|Participant Flow|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 milligrams [mg] tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 milligrams per kilogram [mg/kg] syrup) on Day 1, followed by 5-day washout. Vemurafenib (RO5185426) 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260781|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260782|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260783|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260784|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
261243|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
260785|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260786|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260787|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260788|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260789|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260790|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260791|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260792|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260793|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260794|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260807|NCT01001234|B2|Baseline|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
261244|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
271387|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
260795|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260796|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260797|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260798|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260799|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260800|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260801|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260802|NCT01001299|E1|Reported Event|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
260803|NCT01001234|B6|Baseline|Total|Total of all reporting groups
260804|NCT01001234|B5|Baseline|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
260805|NCT01001234|B4|Baseline|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
260806|NCT01001234|B3|Baseline|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
261245|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
260808|NCT01001234|B1|Baseline|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
260809|NCT01001234|P5|Participant Flow|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
260810|NCT01001234|P4|Participant Flow|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
260811|NCT01001234|P3|Participant Flow|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
260812|NCT01001234|P2|Participant Flow|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
260813|NCT01001234|P1|Participant Flow|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
260814|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
260815|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
260816|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
260817|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
260818|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
260819|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
260820|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
260821|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
260822|NCT01001234|E2|Reported Event|Placebo|Participants who took only placebo during the study
260823|NCT01001234|E1|Reported Event|Rizatriptan|Participants who took any rizatriptan during the study (Stage 1 or 2)
260824|NCT01001221|B5|Baseline|Total|Total of all reporting groups
260825|NCT01001221|B4|Baseline|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260826|NCT01001221|B3|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260827|NCT01001221|B2|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260828|NCT01001221|B1|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260829|NCT01001221|P5|Participant Flow|Part 2: Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the Maximum Tolerated Dose (MTD) as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260830|NCT01001221|P4|Participant Flow|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260831|NCT01001221|P3|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260832|NCT01001221|P2|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260833|NCT01001221|P1|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260834|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260835|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260836|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260837|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260838|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260839|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260840|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260841|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260842|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260843|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260844|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260845|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260846|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260847|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260848|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260849|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260850|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260851|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260852|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260853|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260854|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260855|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260856|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260857|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260858|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261039|NCT01001195|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260859|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260860|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260861|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260862|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260863|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260864|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260865|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260866|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260867|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260868|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260869|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260870|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260871|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260872|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260873|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260874|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260875|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260876|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260877|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260878|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260879|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260880|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260881|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261040|NCT01001195|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260882|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260883|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260884|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260885|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260886|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260887|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260888|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260889|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260890|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260891|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260892|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260893|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260894|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260895|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260896|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260897|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260898|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260899|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260900|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260901|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260902|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260903|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260904|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261041|NCT01001195|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260905|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260906|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260907|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260908|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260909|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260910|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260911|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260912|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260913|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260914|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260915|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260916|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260917|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260918|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260919|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260920|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260921|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260922|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260923|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260924|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260925|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260926|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260927|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261042|NCT01001195|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260928|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260929|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260930|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260931|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260932|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260933|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260934|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260935|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260936|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260937|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260938|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260939|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260940|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260941|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260942|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260943|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260944|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260945|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260946|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260947|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260948|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260949|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260950|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261043|NCT01001195|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260951|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260952|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260953|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260954|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260955|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260956|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260957|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260958|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260959|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260960|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260961|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260962|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260963|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260964|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260965|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260966|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260967|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260968|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260969|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260970|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260971|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260972|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260973|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261044|NCT01001195|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
260974|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260975|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260976|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260977|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260978|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260979|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260980|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260981|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260982|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260983|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260984|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260985|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260986|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260987|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260988|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260989|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260990|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260991|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260992|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260993|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260994|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260995|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260996|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261246|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261880|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
260997|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260998|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
260999|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261000|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261001|NCT01001221|E4|Reported Event|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261002|NCT01001221|E3|Reported Event|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261003|NCT01001221|E2|Reported Event|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261004|NCT01001221|E1|Reported Event|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
261005|NCT01001208|B3|Baseline|Total|Total of all reporting groups
261006|NCT01001208|B2|Baseline|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261007|NCT01001208|B1|Baseline|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261008|NCT01001208|P2|Participant Flow|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261009|NCT01001208|P1|Participant Flow|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261010|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261011|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261012|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261013|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261014|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261015|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261016|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261017|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261018|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261019|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261020|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261021|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261022|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261023|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261024|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261025|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261026|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261027|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261028|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261029|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261030|NCT01001208|E2|Reported Event|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
261031|NCT01001208|E1|Reported Event|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
261032|NCT01001195|B5|Baseline|Total|Total of all reporting groups
261033|NCT01001195|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261034|NCT01001195|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261035|NCT01001195|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261036|NCT01001195|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261037|NCT01001195|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261038|NCT01001195|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261457|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
261045|NCT01001195|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261046|NCT01001195|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261047|NCT01001195|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261048|NCT01001195|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
261049|NCT01001104|B5|Baseline|Total|Total of all reporting groups
261050|NCT01001104|B4|Baseline|Placebo|Administered by SC injection, QW for 12 weeks.
261051|NCT01001104|B3|Baseline|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261052|NCT01001104|B2|Baseline|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261053|NCT01001104|B1|Baseline|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261054|NCT01001104|P4|Participant Flow|Placebo|Administered by SC injection, QW for 12 weeks.
261055|NCT01001104|P3|Participant Flow|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261056|NCT01001104|P2|Participant Flow|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261057|NCT01001104|P1|Participant Flow|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261058|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261059|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261060|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261061|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261062|NCT01001104|O3|Outcome|LY 0.75 mg|Administered by SC injection, QW for 12 weeks.
261063|NCT01001104|O2|Outcome|LY 0.50 mg|Administered by SC injection, QW for 12 weeks.
261064|NCT01001104|O1|Outcome|LY 0.25 mg|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261065|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261066|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261067|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261068|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261069|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261070|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261071|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261072|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261073|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261074|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261075|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261076|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261077|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261078|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261079|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261080|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261081|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261082|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261083|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261084|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261085|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261086|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261087|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261088|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261089|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261090|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261091|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261092|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261093|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
261094|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261095|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261096|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261097|NCT01001104|E4|Reported Event|0.75 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261098|NCT01001104|E3|Reported Event|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261099|NCT01001104|E2|Reported Event|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
261100|NCT01001104|E1|Reported Event|Placebo|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
261101|NCT01001078|B3|Baseline|Total|Total of all reporting groups
261881|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
261102|NCT01001078|B2|Baseline|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261103|NCT01001078|B1|Baseline|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261104|NCT01001078|P2|Participant Flow|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261105|NCT01001078|P1|Participant Flow|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261106|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261107|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261108|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
261109|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
261110|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261111|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261128|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261129|NCT01001052|E2|Reported Event|Colcrys™ - Elderly Subjects (>60 Years Old)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
261130|NCT01001052|E1|Reported Event|Colcrys™ - Young Subjects (18-30 Years)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
261131|NCT01000974|B4|Baseline|Total|Total of all reporting groups
261112|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261113|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261114|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
261115|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
261116|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261117|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261118|NCT01001078|E2|Reported Event|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
261119|NCT01001078|E1|Reported Event|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
261120|NCT01001052|B1|Baseline|Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects|"Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.~Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours."
261121|NCT01001052|P2|Participant Flow|Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)|All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261122|NCT01001052|P1|Participant Flow|Colcrys™ (Colchicine) - Young Subjects (18-30 Years)|All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261123|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261124|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261125|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261126|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261127|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
261132|NCT01000974|B3|Baseline|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261133|NCT01000974|B2|Baseline|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261134|NCT01000974|B1|Baseline|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261135|NCT01000974|P3|Participant Flow|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261136|NCT01000974|P2|Participant Flow|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261137|NCT01000974|P1|Participant Flow|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261138|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261139|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261140|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261141|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261247|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261248|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261249|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261250|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261142|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261143|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261144|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261145|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261146|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261147|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261148|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261149|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261150|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261151|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261152|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261458|NCT00999921|E2|Reported Event|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
261153|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261154|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261155|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261156|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261157|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261158|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261159|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261160|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261161|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261162|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261163|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261164|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261165|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261166|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261167|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
261168|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261169|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261170|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261171|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261172|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261173|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261185|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261882|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
261174|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261175|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261176|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261177|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261178|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261179|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261180|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261181|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261182|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261183|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261184|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261186|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261187|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261188|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
261189|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261190|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261191|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261192|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261193|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261194|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261195|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261196|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261197|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261198|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261199|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261200|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261201|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261202|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261203|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261204|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261205|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261206|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261238|NCT01000805|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
261239|NCT01000805|P1|Participant Flow|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261240|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261241|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261242|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261207|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261208|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261209|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261210|NCT01000974|E3|Reported Event|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
261211|NCT01000974|E2|Reported Event|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261212|NCT01000974|E1|Reported Event|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
261213|NCT01000961|B1|Baseline|RP103 and Cystagon® Crossover|Per Protocol Population
261214|NCT01000961|P2|Participant Flow|Cystagon First, Then RP103, Then Cystagon|RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
261215|NCT01000961|P1|Participant Flow|Cystagon First, Then Cystagon, Then RP103|Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
261216|NCT01000961|O2|Outcome|RP103|Per Protocol Population
261217|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
261218|NCT01000961|O2|Outcome|RP103|Per Protocol Population
261219|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
261220|NCT01000961|O2|Outcome|RP103|Per Protocol Population
261221|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
261222|NCT01000961|O2|Outcome|Cystagon®|Per Protocol Population
261223|NCT01000961|O1|Outcome|RP103|Per Protocol Population
261224|NCT01000961|E2|Reported Event|Cystagon®|Safety population during treatment periods
261225|NCT01000961|E1|Reported Event|RP103|Safety Population during treatment periods
261226|NCT01000818|B1|Baseline|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
261227|NCT01000818|P1|Participant Flow|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
261228|NCT01000818|O3|Outcome|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
261229|NCT01000818|O2|Outcome|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
261230|NCT01000818|O1|Outcome|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
261231|NCT01000818|E4|Reported Event|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
261232|NCT01000818|E3|Reported Event|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
261233|NCT01000818|E2|Reported Event|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
261234|NCT01000818|E1|Reported Event|Prestudy|
261235|NCT01000805|B3|Baseline|Total|Total of all reporting groups
261236|NCT01000805|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
261237|NCT01000805|B1|Baseline|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261251|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261252|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261253|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261254|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261255|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261256|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261257|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261258|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261259|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261260|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261261|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261262|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261263|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261264|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261265|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
261266|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
261267|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261268|NCT01000805|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
261269|NCT01000805|E1|Reported Event|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
261270|NCT01000662|B3|Baseline|Total|Total of all reporting groups
261271|NCT01000662|B2|Baseline|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261272|NCT01000662|B1|Baseline|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261273|NCT01000662|P2|Participant Flow|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261274|NCT01000662|P1|Participant Flow|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261275|NCT01000662|O2|Outcome|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261276|NCT01000662|O1|Outcome|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261277|NCT01000662|E2|Reported Event|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261278|NCT01000662|E1|Reported Event|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
261279|NCT01000610|B1|Baseline|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261280|NCT01000610|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
261281|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261282|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261283|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261284|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261285|NCT01000610|E1|Reported Event|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
261286|NCT01000506|B5|Baseline|Total|Total of all reporting groups
261287|NCT01000506|B4|Baseline|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261288|NCT01000506|B3|Baseline|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261289|NCT01000506|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261290|NCT01000506|B1|Baseline|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261291|NCT01000506|P4|Participant Flow|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261292|NCT01000506|P3|Participant Flow|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261293|NCT01000506|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261294|NCT01000506|P1|Participant Flow|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261295|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261296|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261297|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261298|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261299|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261300|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261301|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
271388|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
261302|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261303|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261304|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261305|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261306|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261307|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261308|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261309|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261310|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261311|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261312|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261313|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261314|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261315|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261316|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261317|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261318|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261319|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261320|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261321|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261322|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261323|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261324|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261325|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261326|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261327|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261328|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261329|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261330|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261331|NCT01000506|E4|Reported Event|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261332|NCT01000506|E3|Reported Event|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261333|NCT01000506|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261334|NCT01000506|E1|Reported Event|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
261345|NCT01000376|P1|Participant Flow|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261346|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261335|NCT01000480|B1|Baseline|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261336|NCT01000480|P1|Participant Flow|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261337|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261338|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261339|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261340|NCT01000480|E1|Reported Event|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
261341|NCT01000376|B3|Baseline|Total|Total of all reporting groups
261342|NCT01000376|B2|Baseline|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261343|NCT01000376|B1|Baseline|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261344|NCT01000376|P2|Participant Flow|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261453|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
261347|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261348|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261349|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261350|NCT01000376|E2|Reported Event|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261351|NCT01000376|E1|Reported Event|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
261352|NCT01000337|B3|Baseline|Total|Total of all reporting groups
261353|NCT01000337|B2|Baseline|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
261354|NCT01000337|B1|Baseline|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
261355|NCT01000337|P2|Participant Flow|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
261356|NCT01000337|P1|Participant Flow|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
261357|NCT01000337|O2|Outcome|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
261358|NCT01000337|O1|Outcome|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
261359|NCT01000337|E2|Reported Event|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
261360|NCT01000337|E1|Reported Event|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
261361|NCT01000324|B1|Baseline|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261362|NCT01000324|P1|Participant Flow|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261363|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
261364|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
261365|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261454|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
261366|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261367|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261368|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261369|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261370|NCT01000324|E1|Reported Event|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
261371|NCT01000311|B3|Baseline|Total|Total of all reporting groups
261372|NCT01000311|B2|Baseline|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261373|NCT01000311|B1|Baseline|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261374|NCT01000311|P2|Participant Flow|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261375|NCT01000311|P1|Participant Flow|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261376|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261377|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261378|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261379|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261380|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261381|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261382|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261383|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261384|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261385|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261386|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261387|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261388|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261389|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261390|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261391|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261392|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261393|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261394|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
271389|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
261395|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261396|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261397|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261398|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261399|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261400|NCT01000311|E2|Reported Event|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
261401|NCT01000311|E1|Reported Event|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
261402|NCT01000285|B3|Baseline|Total|Total of all reporting groups
261403|NCT01000285|B2|Baseline|Lymphoma ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261404|NCT01000285|B1|Baseline|Acute ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261405|NCT01000285|P1|Participant Flow|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261406|NCT01000285|O1|Outcome|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261407|NCT01000285|O1|Outcome|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261408|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
261409|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
261410|NCT01000285|O8|Outcome|Patient D (Non-responder) Post-Therapy|
261411|NCT01000285|O7|Outcome|Patient D (Non-responder) Pre-Therapy|
261412|NCT01000285|O6|Outcome|Patient C (Non-responder) Post-Therapy|
261413|NCT01000285|O5|Outcome|Patient C (Non-responder) Pre-Therapy|
261414|NCT01000285|O4|Outcome|Patient B (Responder) Post-Therapy|
261415|NCT01000285|O3|Outcome|Patient B (Responder) Pre-Therapy|
261416|NCT01000285|O2|Outcome|Patient A (Responder) Post-Therapy|
261417|NCT01000285|O1|Outcome|Patient A (Responder) Pre-Therapy|
261418|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
261419|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
261420|NCT01000285|O1|Outcome|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261421|NCT01000285|O1|Outcome|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261422|NCT01000285|O1|Outcome|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261455|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
261456|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
261423|NCT01000285|E1|Reported Event|Arm 1|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
261424|NCT01000155|B1|Baseline|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
261425|NCT01000155|P1|Participant Flow|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
261426|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
261427|NCT01000155|E1|Reported Event|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
261428|NCT01000025|B3|Baseline|Total|Total of all reporting groups
261429|NCT01000025|B2|Baseline|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261430|NCT01000025|B1|Baseline|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261431|NCT01000025|P2|Participant Flow|Placebo|Control arm
261432|NCT01000025|P1|Participant Flow|PF-804|Study treatment arm
261433|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261434|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261435|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261436|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261437|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261438|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261439|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261440|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261441|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261442|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261443|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261444|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261445|NCT01000025|E2|Reported Event|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
261446|NCT01000025|E1|Reported Event|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
261447|NCT00999921|B3|Baseline|Total|Total of all reporting groups
261448|NCT00999921|B2|Baseline|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
261449|NCT00999921|B1|Baseline|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
261450|NCT00999921|P2|Participant Flow|Evening Primrose Oil|Evening Primrose Oil 1000 mg daily for 3 months
261451|NCT00999921|P1|Participant Flow|Tamoxifen|Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
261452|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
261459|NCT00999921|E1|Reported Event|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
261460|NCT00999908|B1|Baseline|Entire Study Population|The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261461|NCT00999908|P3|Participant Flow|Placebo-indacaterol 150 μg-tiotropium 18 μg|Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261462|NCT00999908|P2|Participant Flow|Tiotropium 18 μg-placebo-indacaterol 150 μg|Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261463|NCT00999908|P1|Participant Flow|Indacaterol 150 μg-tiotropium 18 μg-placebo|Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261464|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261465|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261466|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261467|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261468|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261469|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261470|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261471|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261472|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261473|NCT00999908|E3|Reported Event|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261474|NCT00999908|E2|Reported Event|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261475|NCT00999908|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
261476|NCT00999830|B3|Baseline|Total|Total of all reporting groups
261477|NCT00999830|B2|Baseline|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261478|NCT00999830|B1|Baseline|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261479|NCT00999830|P2|Participant Flow|Arm B: IPH2101 2mg/kg|IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
261480|NCT00999830|P1|Participant Flow|Arm A: IPH2101 0.2mg/Kg|IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
261481|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261482|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261483|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261484|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261485|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261486|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261487|NCT00999830|E2|Reported Event|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261488|NCT00999830|E1|Reported Event|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
261489|NCT00999804|B3|Baseline|Total|Total of all reporting groups
261556|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261883|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
261490|NCT00999804|B2|Baseline|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261491|NCT00999804|B1|Baseline|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261492|NCT00999804|P2|Participant Flow|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261493|NCT00999804|P1|Participant Flow|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261494|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261495|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261496|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261497|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261498|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261499|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261500|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261501|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261502|NCT00999804|E2|Reported Event|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261503|NCT00999804|E1|Reported Event|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
261504|NCT00999687|B1|Baseline|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
261505|NCT00999687|P1|Participant Flow|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
261506|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
261507|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
261508|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
261509|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
261557|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261558|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261510|NCT00999687|E1|Reported Event|All Participants (Indigo Naturalis Oil Extreact/Olive Oil)|"Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.~In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks."
261511|NCT00999661|B1|Baseline|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261512|NCT00999661|P1|Participant Flow|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261513|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261514|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261515|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261516|NCT00999661|E1|Reported Event|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
261517|NCT00999596|B1|Baseline|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
261518|NCT00999596|P1|Participant Flow|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
261519|NCT00999596|O2|Outcome|FFDM Mammograms Score = Fail|Mammogram sets from the Philips Digital System with Fail score for Image Quality
261520|NCT00999596|O1|Outcome|FFDM Mammograms Score = Pass|Mammogram sets from the Philips Digital System with Pass score for Image Quality
261521|NCT00999596|E1|Reported Event|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
261522|NCT00999544|B1|Baseline|Crossover Within Subject|All subjects were exposed to every condition.
261523|NCT00999544|P1|Participant Flow|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
261524|NCT00999544|O15|Outcome|Aprepitant 200 mg- 40 Oxycodone Oral|All subjects received exposure to this study condition once.
261525|NCT00999544|O14|Outcome|Aprepitant 200 mg- 20 Oxycodone Oral|All subjects received exposure to this study condition once.
261526|NCT00999544|O13|Outcome|Aprepitant 200 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261527|NCT00999544|O12|Outcome|Aprepitant 200 mg - 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261528|NCT00999544|O11|Outcome|Aprepitant 40 mg - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
261529|NCT00999544|O10|Outcome|Aprepitant 40 mg- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
261530|NCT00999544|O9|Outcome|Aprepitant 40 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261531|NCT00999544|O8|Outcome|Aprepitant 40 mg- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261532|NCT00999544|O7|Outcome|Placebo - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
261533|NCT00999544|O6|Outcome|Placebo- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
261534|NCT00999544|O5|Outcome|Placebo- 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261535|NCT00999544|O4|Outcome|Placebo- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
261536|NCT00999544|O3|Outcome|Aprepitant 200 mg- Placebo|All subjects received exposure to this study condition once.
261537|NCT00999544|O2|Outcome|Aprepitant 40 mg - Placebo|All subjects received exposure to this study condition once.
261538|NCT00999544|O1|Outcome|Placebo-Placebo (in and po)|All subjects received exposure to this study condition once.
261539|NCT00999544|E1|Reported Event|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. This was not a parallel group design.
261540|NCT00999466|B4|Baseline|Total|Total of all reporting groups
261541|NCT00999466|B3|Baseline|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261542|NCT00999466|B2|Baseline|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261543|NCT00999466|B1|Baseline|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261544|NCT00999466|P3|Participant Flow|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261545|NCT00999466|P2|Participant Flow|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261546|NCT00999466|P1|Participant Flow|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261547|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261548|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261549|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261550|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261551|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261552|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261553|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261554|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261555|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261559|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261560|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261561|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261562|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261563|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261564|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261565|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261566|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261567|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261568|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261569|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261570|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261571|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261572|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261573|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261574|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261575|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261576|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261577|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261578|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261579|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261580|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261581|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261582|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261583|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261584|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261585|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261586|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261587|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261588|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261589|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261590|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261591|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261592|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261593|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261594|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261595|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261596|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261597|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261598|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261599|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261600|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261601|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261602|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261603|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261604|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261605|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261606|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261607|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261608|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261609|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261610|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261611|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261612|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261613|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261614|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261615|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261616|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261617|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261618|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261619|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261620|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261621|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261622|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261623|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261624|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261625|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261626|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261627|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261628|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261629|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261630|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261631|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261632|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261633|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261634|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261635|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261636|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261637|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261638|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261639|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261640|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261641|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261642|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261643|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261644|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261645|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261646|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261647|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261648|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261649|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261650|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261651|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261652|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261653|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261654|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261655|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261656|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261657|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261658|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261659|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261660|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261661|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261662|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261663|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261664|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261665|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261666|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261667|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261668|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261669|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261670|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261671|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261672|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261673|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261674|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261675|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261676|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261677|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261678|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261679|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261680|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261681|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261682|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261683|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261684|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261685|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261686|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261687|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261688|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261689|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261690|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261691|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261692|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261693|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261694|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261695|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261696|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261697|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261698|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261699|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261700|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261701|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261702|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261703|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261704|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261705|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261706|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261707|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261708|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
271390|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
261709|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261710|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261711|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261712|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261713|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261714|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261715|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261716|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261717|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261718|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261719|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261720|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261721|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261722|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261723|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261724|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261725|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261726|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261727|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261728|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261729|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261730|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261731|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261732|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261733|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261734|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261735|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261736|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261737|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261738|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261739|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261740|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261741|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261742|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261743|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261744|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261745|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261746|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261747|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261748|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261749|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261750|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261751|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261752|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261753|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261754|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261755|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261756|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261757|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261758|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261759|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261760|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261761|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261762|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261763|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261764|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261765|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261766|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261767|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261768|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261769|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261770|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261771|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261772|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261773|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261774|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261775|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261776|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261777|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261778|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261779|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261780|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261781|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261782|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261783|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261784|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261785|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261786|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261787|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261788|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261789|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261790|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261791|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261792|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261793|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261794|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261795|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261796|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261797|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261798|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261799|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261800|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261801|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261802|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261803|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261804|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261805|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261806|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261807|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261808|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261809|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261810|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261811|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261812|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261813|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261814|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261815|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261816|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261817|NCT00999466|E3|Reported Event|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
261818|NCT00999466|E2|Reported Event|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
261819|NCT00999466|E1|Reported Event|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
261820|NCT00999167|B3|Baseline|Total|Total of all reporting groups
261821|NCT00999167|B2|Baseline|Placebo|6 mL BID
261822|NCT00999167|B1|Baseline|HPN-100|6 mL BID
261823|NCT00999167|P3|Participant Flow|Placebo|Subjects will receive 6 mL BID placebo for 16 weeks (Part B)
261824|NCT00999167|P2|Participant Flow|HPN-100 6 mL|Subjects will receive 6 mL BID HPN-100 for 16 weeks (Part B)
261825|NCT00999167|P1|Participant Flow|HPN-100 6 mL and 9 mL|Subjects will undergo a one step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following a satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.
261826|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
261827|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
261828|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
261829|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
261830|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
261831|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
261832|NCT00999167|O2|Outcome|Placebo|6 mL BID
261833|NCT00999167|O1|Outcome|HPN-100|6 mL BID
261834|NCT00999167|O1|Outcome|HPN-100 BID|6 mL or 9 mL BID HPN-100 (Part A)
261835|NCT00999167|E3|Reported Event|Part B: Placebo|Matching HPN-100 placebo, 6 mL BID
261836|NCT00999167|E2|Reported Event|Part B: HPN-100|6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day
261837|NCT00999167|E1|Reported Event|Part A: HPN-100|6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively
261838|NCT00999141|B1|Baseline|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
261839|NCT00999141|P1|Participant Flow|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
261840|NCT00999141|O2|Outcome|Related Facial Adverse Events|
261841|NCT00999141|O1|Outcome|Related Non-Facial Adverse Events|
261842|NCT00999141|O4|Outcome|SoC Side - Seroma|
261843|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Seroma|
261844|NCT00999141|O2|Outcome|SoC Side - Hematoma|
261845|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
261846|NCT00999141|O5|Outcome|Confident|
261847|NCT00999141|O4|Outcome|Somewhat Confident|
261848|NCT00999141|O3|Outcome|Neutral|
261849|NCT00999141|O2|Outcome|Not Very Confident|
261850|NCT00999141|O1|Outcome|Not Confident|
261851|NCT00999141|O5|Outcome|Very Satisfied|
261852|NCT00999141|O4|Outcome|Moderately Satisfied|
261853|NCT00999141|O3|Outcome|Somewhat Satisfied|
261854|NCT00999141|O2|Outcome|A Little Satisfied|
261855|NCT00999141|O1|Outcome|Not at All Satisfied|
261856|NCT00999141|O5|Outcome|Very Satisfied|
261857|NCT00999141|O4|Outcome|Moderately Satisfied|
261858|NCT00999141|O3|Outcome|Somewhat Satisfied|
261859|NCT00999141|O2|Outcome|A Little Satisfied|
261860|NCT00999141|O1|Outcome|Not at All Satisfied|
261861|NCT00999141|O5|Outcome|Very Satisfied|
261862|NCT00999141|O4|Outcome|Moderately Satisfied|
261863|NCT00999141|O3|Outcome|Somewhat Satisfied|
261864|NCT00999141|O2|Outcome|A Little Satisfied|
261865|NCT00999141|O1|Outcome|Not at All Satisfied|
261866|NCT00999141|O5|Outcome|Strongly Prefer SoC Side|
261867|NCT00999141|O4|Outcome|Somewhat Prefer SoC Side|
261868|NCT00999141|O3|Outcome|No Preference|
261869|NCT00999141|O2|Outcome|Somewhat Prefer FS VH S/D 4 S-apr Side|
261870|NCT00999141|O1|Outcome|Strongly Prefer FS VH S/D 4 S-apr Side|
261871|NCT00999141|O1|Outcome|Facelift Participants|
261872|NCT00999141|O8|Outcome|SoC Side - Day 14|
261873|NCT00999141|O7|Outcome|FS VH S/D 4 S-apr Side - Day 14|
261874|NCT00999141|O6|Outcome|SoC Side - Day 7|
261875|NCT00999141|O5|Outcome|FS VH S/D 4 S-apr Side - Day 7|
261876|NCT00999141|O4|Outcome|SoC Side - Day 3|
261877|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Day 3|
261878|NCT00999141|O2|Outcome|SoC Side - Day 1|
261879|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Day 1|
261884|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
261885|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
261886|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
261887|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
261888|NCT00999141|O3|Outcome|Participants With No Preference|
261889|NCT00999141|O2|Outcome|Participants Preferring SoC|
261890|NCT00999141|O1|Outcome|Participants Preferring FS VH S/D 4 S-apr|
261891|NCT00999141|O2|Outcome|Standard of Care (SoC)|
261892|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|
261893|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
261894|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
261895|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
261896|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
261897|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
261898|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
261899|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
261900|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
261901|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
261902|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
261903|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
261904|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
261905|NCT00999141|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
261906|NCT00999141|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
261907|NCT00999141|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
261908|NCT00999141|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 S-apr Side|
261909|NCT00999141|O2|Outcome|Standard of Care (SoC)|Participants With Hematoma/Seroma on SoC Side
261910|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|Participants With Hematoma/Seroma on FS VH S/D 4 s-apr Side
261911|NCT00999141|O4|Outcome|Standard of Care (SoC) Side - Seroma|
261912|NCT00999141|O3|Outcome|Standard of Care (SoC) Side - Hematoma|
261913|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr Side - Seroma|
261914|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
261915|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr|
261916|NCT00999141|O1|Outcome|Standard of Care (SoC)|
261917|NCT00999141|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
261918|NCT00999141|E2|Reported Event|Localized to FS VH S/D 4 S-apr Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr
261919|NCT00999141|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care (SoC).
261920|NCT00998985|B15|Baseline|Total|Total of all reporting groups
261921|NCT00998985|B14|Baseline|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261922|NCT00998985|B13|Baseline|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261923|NCT00998985|B12|Baseline|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261924|NCT00998985|B11|Baseline|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261925|NCT00998985|B10|Baseline|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261926|NCT00998985|B9|Baseline|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261927|NCT00998985|B8|Baseline|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261928|NCT00998985|B7|Baseline|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261929|NCT00998985|B6|Baseline|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261930|NCT00998985|B5|Baseline|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261931|NCT00998985|B4|Baseline|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261932|NCT00998985|B3|Baseline|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261933|NCT00998985|B2|Baseline|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261934|NCT00998985|B1|Baseline|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261935|NCT00998985|P14|Participant Flow|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261936|NCT00998985|P13|Participant Flow|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261937|NCT00998985|P12|Participant Flow|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261938|NCT00998985|P11|Participant Flow|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261939|NCT00998985|P10|Participant Flow|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261940|NCT00998985|P9|Participant Flow|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261941|NCT00998985|P8|Participant Flow|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261942|NCT00998985|P7|Participant Flow|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
271391|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
261943|NCT00998985|P6|Participant Flow|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261944|NCT00998985|P5|Participant Flow|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261945|NCT00998985|P4|Participant Flow|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261946|NCT00998985|P3|Participant Flow|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261947|NCT00998985|P2|Participant Flow|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261948|NCT00998985|P1|Participant Flow|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261949|NCT00998985|O14|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261950|NCT00998985|O13|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261951|NCT00998985|O12|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261952|NCT00998985|O11|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261953|NCT00998985|O10|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261954|NCT00998985|O9|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261955|NCT00998985|O8|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261956|NCT00998985|O7|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261957|NCT00998985|O6|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261958|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261959|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261960|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261961|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261962|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261963|NCT00998985|O14|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261964|NCT00998985|O13|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261965|NCT00998985|O12|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261966|NCT00998985|O11|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261967|NCT00998985|O10|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261968|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261969|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261970|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261971|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261972|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261973|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261974|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261975|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261976|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261977|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261978|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261979|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261980|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261981|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261982|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261983|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261984|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261985|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261986|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261987|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261988|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261989|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261990|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
261991|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
261992|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
261993|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
261994|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
261995|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
261996|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
261997|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
261998|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
261999|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
262000|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
262001|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
262002|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
262003|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
262004|NCT00998985|E9|Reported Event|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
262005|NCT00998985|E8|Reported Event|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
262006|NCT00998985|E7|Reported Event|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
262007|NCT00998985|E6|Reported Event|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
262008|NCT00998985|E5|Reported Event|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
262009|NCT00998985|E4|Reported Event|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
262010|NCT00998985|E3|Reported Event|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
262011|NCT00998985|E2|Reported Event|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
262012|NCT00998985|E1|Reported Event|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
262013|NCT00998881|B3|Baseline|Total|Total of all reporting groups
262014|NCT00998881|B2|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262015|NCT00998881|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262016|NCT00998881|P2|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262017|NCT00998881|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262018|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262019|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262020|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262021|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262022|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262023|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262024|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262025|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262026|NCT00998881|E2|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
262027|NCT00998881|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
262028|NCT00998868|B1|Baseline|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262029|NCT00998868|P1|Participant Flow|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262030|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262031|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262032|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262033|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262034|NCT00998868|E1|Reported Event|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
262035|NCT00998764|B3|Baseline|Total|Total of all reporting groups
262036|NCT00998764|B2|Baseline|Bapineuzumab/Bapineuzumab|Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262075|NCT00998660|B1|Baseline|Dystonia Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
262037|NCT00998764|B1|Baseline|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262038|NCT00998764|P2|Participant Flow|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262039|NCT00998764|P1|Participant Flow|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
262040|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262041|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262042|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262043|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262044|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262045|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262046|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262047|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262048|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262049|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262050|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262051|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262052|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262053|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262054|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262055|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262056|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262057|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262058|NCT00998764|E2|Reported Event|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262059|NCT00998764|E1|Reported Event|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
262060|NCT00998738|B1|Baseline|Overall|
262061|NCT00998738|P1|Participant Flow|Overall|
262062|NCT00998738|O1|Outcome|Overall|
262063|NCT00998738|O1|Outcome|Overall|
262064|NCT00998738|O1|Outcome|Overall|
262065|NCT00998738|O1|Outcome|Overall|
262066|NCT00998738|O1|Outcome|Overall|
262067|NCT00998738|O1|Outcome|Overall|
262068|NCT00998738|O1|Outcome|Overall|
262069|NCT00998738|O1|Outcome|Overall|
262070|NCT00998738|O1|Outcome|Overall|
262071|NCT00998738|E1|Reported Event|Overall|
262072|NCT00998660|B4|Baseline|Total|Total of all reporting groups
262073|NCT00998660|B3|Baseline|Parkinsons Disease Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
262074|NCT00998660|B2|Baseline|Essential Tremor Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
262076|NCT00998660|P1|Participant Flow|Patients Receiving an Activa RC Implant|Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
262077|NCT00998660|O1|Outcome|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
262078|NCT00998660|E1|Reported Event|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
262079|NCT00998582|B3|Baseline|Total|Total of all reporting groups
262080|NCT00998582|B2|Baseline|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
262081|NCT00998582|B1|Baseline|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
262082|NCT00998582|P2|Participant Flow|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
262083|NCT00998582|P1|Participant Flow|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
262084|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
262085|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
262086|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
262087|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
262088|NCT00998582|E2|Reported Event|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
262089|NCT00998582|E1|Reported Event|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
262090|NCT00998517|B4|Baseline|Total|Total of all reporting groups
262091|NCT00998517|B3|Baseline|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262092|NCT00998517|B2|Baseline|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262093|NCT00998517|B1|Baseline|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262094|NCT00998517|P3|Participant Flow|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262095|NCT00998517|P2|Participant Flow|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262096|NCT00998517|P1|Participant Flow|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262097|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262098|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262099|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262100|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262101|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262102|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262103|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262104|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262105|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262106|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262107|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262108|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262109|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262110|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262111|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262112|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262113|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262114|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262115|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262116|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262117|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262118|NCT00998517|E3|Reported Event|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
262119|NCT00998517|E2|Reported Event|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
262120|NCT00998517|E1|Reported Event|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
262144|NCT00998335|P2|Participant Flow|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262145|NCT00998335|P1|Participant Flow|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262121|NCT00998426|B1|Baseline|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
262122|NCT00998426|P1|Participant Flow|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
262123|NCT00998426|O1|Outcome|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
262124|NCT00998426|E2|Reported Event|Chronic Phase|"Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~glucose monitoring before and after HepaGam B administration: Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.~HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi"
262125|NCT00998426|E1|Reported Event|Acute Phase|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
262126|NCT00998374|B3|Baseline|Total|Total of all reporting groups
262127|NCT00998374|B2|Baseline|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass
262128|NCT00998374|B1|Baseline|Pyloric-sparing|Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
262129|NCT00998374|P2|Participant Flow|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
262130|NCT00998374|P1|Participant Flow|Pyloric-sparing|Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
262131|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
262132|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
262133|NCT00998374|O2|Outcome|Non-pyloric|Non-pyloric: RYGB
262134|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
262135|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
262136|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
262137|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric sparing: RYGB
262138|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
262139|NCT00998374|E2|Reported Event|Non-pyloric Sparing|Non-pyloric: RYGB
262140|NCT00998374|E1|Reported Event|Pyloric-sparing|Pyloric: SG & DS
262141|NCT00998335|B3|Baseline|Total|Total of all reporting groups
262142|NCT00998335|B2|Baseline|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262143|NCT00998335|B1|Baseline|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
271392|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
262146|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.~Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner."
262147|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).~Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262148|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
262149|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262150|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262151|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
262152|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262153|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
262154|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262155|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
262156|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
262157|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262158|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
262159|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
264037|NCT00995904|B1|Baseline|All Patients|All patients that were enrolled in the study.
262160|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
262161|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262162|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
262163|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262164|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262165|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
262166|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262167|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
262168|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262169|NCT00998335|O1|Outcome|Insulin Detemir x 3 Months (All Pts Had Liver MRS)|Liver fat by MRS measured after 3 months of insulin.
262170|NCT00998335|E2|Reported Event|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
262171|NCT00998335|E1|Reported Event|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
262172|NCT00998309|B1|Baseline|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262173|NCT00998309|P1|Participant Flow|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262174|NCT00998309|O2|Outcome|Azithromycin With Pregnancy in Female|Female participants with Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262175|NCT00998309|O1|Outcome|Azithromycin Without Pregnancy in Female|Female participants without Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262176|NCT00998309|O2|Outcome|Azithromycin With Non-drug Therapy|Participants with non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262177|NCT00998309|O1|Outcome|Azithromycin Without Non-drug Therapy|Participants without non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262178|NCT00998309|O2|Outcome|Azithromycin- With Comcomittant Drugs|Participants with comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262319|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262179|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262180|NCT00998309|O2|Outcome|Azithromycin-with PATH|Participants with previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262181|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262182|NCT00998309|O2|Outcome|Azithromycin-with Complications|Participants with complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262183|NCT00998309|O1|Outcome|Azithromycin -Without Complications|Participants without complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262184|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262185|NCT00998309|O1|Outcome|Azithromycin -Without Past Medical History|Participants without Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262186|NCT00998309|O2|Outcome|Azithromycin- With Renal Dysfunction|Participants with Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262187|NCT00998309|O1|Outcome|Azithromycin Without Renal Dysfunction|Participants without Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262188|NCT00998309|O2|Outcome|Azithromycin With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262189|NCT00998309|O1|Outcome|Azithromycin Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262190|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262191|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262192|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262193|NCT00998309|O3|Outcome|Azithromycin-Dental, or Oral Surgery Infection|Participants with Dental, or Oral Surgery Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262194|NCT00998309|O2|Outcome|Azithromycin - Sexual Transmitted Infection|"Participants with Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infectionwho took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert."
262195|NCT00998309|O1|Outcome|Azithromycin - Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262196|NCT00998309|O2|Outcome|Azithromycin >=65 Years|Participants >=65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262197|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262198|NCT00998309|O2|Outcome|Azithromycin Female|Female participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262199|NCT00998309|O1|Outcome|Azithromycin Male|Male participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262200|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262201|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262202|NCT00998309|O2|Outcome|Azithromycin-with Non-Drug Therapy|Participants with Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262203|NCT00998309|O1|Outcome|Azithromycin -With Non-Drug Therapy|Participants without Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262204|NCT00998309|O2|Outcome|Azithromycin With Comcomittant Drugs|Participants with Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262205|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262206|NCT00998309|O2|Outcome|Azithromycin With PATH|Participants with Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262207|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262208|NCT00998309|O2|Outcome|Azithromycin With Complications|Participants with Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262209|NCT00998309|O1|Outcome|Azithromycin Without Complications|Participants without Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262210|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262211|NCT00998309|O1|Outcome|Azithromycin-without Past Medical History|Participants without Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262212|NCT00998309|O2|Outcome|Azithromycin-with Renal Dysfunction|Participants with Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262213|NCT00998309|O1|Outcome|Azithromycin-without Renal Dysfunction|Participants without Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262214|NCT00998309|O2|Outcome|Azithromycin-with Hepatic Dysfunction|Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262215|NCT00998309|O1|Outcome|Azithromycin -Without Hepatic Dysfunction|Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262216|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262217|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|"Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.~, moderate infection, or severe in"
262218|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262219|NCT00998309|O3|Outcome|Aazithromycin-Dental and Oral Surgery Infection|Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262220|NCT00998309|O2|Outcome|Azithromycin-Sexual Transmitted Infection|Participants with Sexual Transmitted Infection (STI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262221|NCT00998309|O1|Outcome|Azithromycin -Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection (SSTI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262222|NCT00998309|O2|Outcome|Azithromycin->=65 Years|Participants>=65 years who took Azithromycin SR as a single dose of 2 g (potency, as azithromycin) with an empty stomach according to Japanese Package Insert.
262223|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants with <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262224|NCT00998309|O2|Outcome|Azithromycin-Female|Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262225|NCT00998309|O1|Outcome|Azithromycin -Male|Male participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262226|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262227|NCT00998309|E1|Reported Event|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
262228|NCT00998296|B12|Baseline|Total|Total of all reporting groups
262229|NCT00998296|B11|Baseline|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262230|NCT00998296|B10|Baseline|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262231|NCT00998296|B9|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262232|NCT00998296|B8|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262233|NCT00998296|B7|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262234|NCT00998296|B6|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262235|NCT00998296|B5|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262236|NCT00998296|B4|Baseline|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262237|NCT00998296|B3|Baseline|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262238|NCT00998296|B2|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
271393|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
262239|NCT00998296|B1|Baseline|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262240|NCT00998296|P11|Participant Flow|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262241|NCT00998296|P10|Participant Flow|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262242|NCT00998296|P9|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262243|NCT00998296|P8|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262244|NCT00998296|P7|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262245|NCT00998296|P6|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262246|NCT00998296|P5|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262247|NCT00998296|P4|Participant Flow|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262248|NCT00998296|P3|Participant Flow|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262249|NCT00998296|P2|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262250|NCT00998296|P1|Participant Flow|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262251|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262252|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262253|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262254|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262255|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262256|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262320|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262257|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262258|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262259|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262260|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262261|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg- Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262262|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg- Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262263|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262264|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262265|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262266|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262267|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262268|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262269|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262270|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262271|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262272|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262273|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262274|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262275|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
263532|NCT00996658|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
262276|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262277|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262278|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262279|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262280|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262281|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262282|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262283|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262284|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262285|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
262286|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262287|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262288|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262289|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262290|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262291|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262292|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262293|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262294|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262295|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262321|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
263533|NCT00996658|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
262296|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262297|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262298|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
262299|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262300|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262301|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262302|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262303|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262304|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
262305|NCT00998296|E11|Reported Event|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the expansion phase which follows on the dose-escalation phase."
262306|NCT00998296|E10|Reported Event|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
262307|NCT00998296|E9|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
262308|NCT00998296|E8|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
262309|NCT00998296|E7|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
262310|NCT00998296|E6|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
262311|NCT00998296|E5|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
262312|NCT00998296|E4|Reported Event|Nintedanib 200 mg +Afatinib 20 mg - Continuosly|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
262313|NCT00998296|E3|Reported Event|Nintedanib 200 mg +Afatinib 10 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
262314|NCT00998296|E2|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
262315|NCT00998296|E1|Reported Event|Nintedanib 150 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
262316|NCT00998049|B1|Baseline|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262317|NCT00998049|P1|Participant Flow|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262318|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
271394|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
262322|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262323|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262324|NCT00998049|E1|Reported Event|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
262325|NCT00998023|B3|Baseline|Total|Total of all reporting groups
262326|NCT00998023|B2|Baseline|AngioSeal VCD|AngioSeal Vascular Closure Device
262327|NCT00998023|B1|Baseline|Mynx VCD|Mynx Vascular Closure Device
262328|NCT00998023|P2|Participant Flow|AngioSeal VCD|AngioSeal Vascular Closure Device
262329|NCT00998023|P1|Participant Flow|Mynx VCD|Mynx Vascular Closure Device
262330|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
262331|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
262332|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
262333|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
262334|NCT00998023|E2|Reported Event|AngioSeal VCD|AngioSeal Vascular Closure Device
262335|NCT00998023|E1|Reported Event|Mynx VCD|Mynx Vascular Closure Device
262336|NCT00997984|B4|Baseline|Total|Total of all reporting groups
262337|NCT00997984|B3|Baseline|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262338|NCT00997984|B2|Baseline|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262339|NCT00997984|B1|Baseline|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262340|NCT00997984|P3|Participant Flow|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262341|NCT00997984|P2|Participant Flow|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262342|NCT00997984|P1|Participant Flow|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262343|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262344|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262345|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262346|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262347|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262348|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262349|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262350|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262351|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262352|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262353|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262354|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262355|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262356|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262357|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262358|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262359|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262360|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262361|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262362|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262363|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262364|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262365|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262366|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262367|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262368|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262369|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262370|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262371|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262372|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262418|NCT00997594|B1|Baseline|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
262373|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262374|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262375|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262376|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262377|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262378|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262379|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262380|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262381|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262382|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262383|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262384|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262385|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262386|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262387|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262388|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262389|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262390|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262391|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262392|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262393|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262394|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262395|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262396|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262397|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262398|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262399|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
262400|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262401|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262402|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262403|NCT00997984|E4|Reported Event|All Active|The combined results of the SPD503 AM and PM groups
262404|NCT00997984|E3|Reported Event|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
262405|NCT00997984|E2|Reported Event|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
262406|NCT00997984|E1|Reported Event|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
262407|NCT00997672|B3|Baseline|Total|Total of all reporting groups
262408|NCT00997672|B2|Baseline|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262409|NCT00997672|B1|Baseline|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262410|NCT00997672|P2|Participant Flow|Placebo|Placebo
262411|NCT00997672|P1|Participant Flow|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262412|NCT00997672|O2|Outcome|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262413|NCT00997672|O1|Outcome|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262414|NCT00997672|E2|Reported Event|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262415|NCT00997672|E1|Reported Event|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
262416|NCT00997594|B3|Baseline|Total|Total of all reporting groups
262417|NCT00997594|B2|Baseline|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
264196|NCT00995449|E1|Reported Event|KB003 70mg|Dose group not evaluated in this portion of study
262419|NCT00997594|P2|Participant Flow|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
262420|NCT00997594|P1|Participant Flow|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
262421|NCT00997594|O2|Outcome|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
262422|NCT00997594|O1|Outcome|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
262423|NCT00997594|E2|Reported Event|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
262424|NCT00997594|E1|Reported Event|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
262425|NCT00997555|B3|Baseline|Total|Total of all reporting groups
262426|NCT00997555|B2|Baseline|Control Group|Standard treatment without scheduled bronchoscopy.
262427|NCT00997555|B1|Baseline|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262428|NCT00997555|P2|Participant Flow|Control Group|Standard treatment without scheduled bronchoscopy.
262429|NCT00997555|P1|Participant Flow|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262430|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262431|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262432|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262433|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262434|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262435|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262436|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262437|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262438|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262439|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262440|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
262441|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262442|NCT00997555|E2|Reported Event|Control Group|Standard treatment without scheduled bronchoscopy.
262443|NCT00997555|E1|Reported Event|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
262444|NCT00997516|B3|Baseline|Total|Total of all reporting groups
262445|NCT00997516|B2|Baseline|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262446|NCT00997516|B1|Baseline|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262447|NCT00997516|P2|Participant Flow|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262448|NCT00997516|P1|Participant Flow|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262449|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262450|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262451|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262452|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262453|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262454|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262455|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262456|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262457|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262458|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262459|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262460|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262461|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262462|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262463|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262464|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262465|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262466|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262467|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262468|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262469|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262470|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262471|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262472|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262473|NCT00997516|E2|Reported Event|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
262474|NCT00997516|E1|Reported Event|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
262475|NCT00997503|B1|Baseline|TAXUS Liberté Post-Approval Study Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262476|NCT00997503|P1|Participant Flow|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262477|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262478|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262479|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262480|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262481|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262482|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262483|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262484|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262485|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262486|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262487|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262488|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262489|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262490|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262491|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262492|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262524|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262493|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262494|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262495|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262496|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262497|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262498|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262499|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262500|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262501|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262502|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262503|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262504|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262505|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262506|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262507|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262508|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262509|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262510|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262511|NCT00997503|O1|Outcome|Medically Treated Diabetic Population|Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
262512|NCT00997503|O1|Outcome|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262513|NCT00997503|O1|Outcome|TAXUS Libertē Post-Approval Study Enrolled Population|There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
262514|NCT00997503|E1|Reported Event|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
262515|NCT00997438|B4|Baseline|Total|Total of all reporting groups
262516|NCT00997438|B3|Baseline|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262517|NCT00997438|B2|Baseline|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262518|NCT00997438|B1|Baseline|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262519|NCT00997438|P3|Participant Flow|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262520|NCT00997438|P2|Participant Flow|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262521|NCT00997438|P1|Participant Flow|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262522|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262523|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262525|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262526|NCT00997438|O2|Outcome|MS - Relapsing Remitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262527|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262528|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262529|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262530|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262531|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262532|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262533|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262534|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262535|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262536|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262537|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262538|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262539|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262540|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262541|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262542|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262543|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262544|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262545|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262546|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262547|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262548|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262549|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262550|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262551|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262552|NCT00997438|E3|Reported Event|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262553|NCT00997438|E2|Reported Event|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262554|NCT00997438|E1|Reported Event|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
262555|NCT00997425|B1|Baseline|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
262556|NCT00997425|P1|Participant Flow|Arm 1 Door Cover; Floor Cover|The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
262557|NCT00997425|O2|Outcome|Floor Cover|"a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door.-"
262558|NCT00997425|O1|Outcome|Door Cover|- a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
262559|NCT00997425|E1|Reported Event|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
262560|NCT00997373|B3|Baseline|Total|Total of all reporting groups
262561|NCT00997373|B2|Baseline|Control|No letrozole before hysterectomy
262562|NCT00997373|B1|Baseline|Letrozole Arm|Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
262563|NCT00997373|P2|Participant Flow|Control|No treatment prior to hysterectomy
262564|NCT00997373|P1|Participant Flow|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
262566|NCT00997373|O1|Outcome|Letrozole|"letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks"
262567|NCT00997373|E2|Reported Event|Control|No treatment prior to hysterectomy
262568|NCT00997373|E1|Reported Event|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
262569|NCT00997321|B3|Baseline|Total|Total of all reporting groups
262570|NCT00997321|B2|Baseline|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
262571|NCT00997321|B1|Baseline|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
262572|NCT00997321|P2|Participant Flow|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
262573|NCT00997321|P1|Participant Flow|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
262574|NCT00997321|O2|Outcome|Ketamine|median depth of sedation by the observers assesment of alertness scale in the ketamine group
262575|NCT00997321|O1|Outcome|Propofol|median depth of sedation by the observers assesment of alertness scale in the propofol group
262576|NCT00997321|O2|Outcome|Ketamine|percentage of subjects reporting pain after the procedure who received ketamine
262577|NCT00997321|O1|Outcome|Propofol|percentage of subjects reporting pain after the procedure who received propofol
262578|NCT00997321|O2|Outcome|Ketamine|time in minutes from the start of the procedure until the return of baseline mental status
262579|NCT00997321|O1|Outcome|Propofol|time in minutes from the start of the procedure until the return of baseline mental status
262580|NCT00997321|O2|Outcome|Ketamine|percentage of participants with respiratory depression
262581|NCT00997321|O1|Outcome|Propofol|percentage of participants with respiratory depression
262582|NCT00997321|E2|Reported Event|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
262583|NCT00997321|E1|Reported Event|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
262584|NCT00997243|B1|Baseline|75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab|5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
262585|NCT00997243|P1|Participant Flow|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262586|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262587|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262588|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262589|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262590|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262591|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262592|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262593|NCT00997243|E1|Reported Event|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
262594|NCT00997204|B3|Baseline|Total|Total of all reporting groups
262595|NCT00997204|B2|Baseline|Naive Patients|Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
262596|NCT00997204|B1|Baseline|Non-Naive Patients|Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
262597|NCT00997204|P2|Participant Flow|Non-Naive Subjects/ Self-administration Phase|Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
262598|NCT00997204|P1|Participant Flow|Naive Subjects/ Naive Treatment Phase|Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
262599|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262600|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262601|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
262602|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262603|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262604|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|"The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.~3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses."
262605|NCT00997204|E3|Reported Event|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262606|NCT00997204|E2|Reported Event|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
262607|NCT00997204|E1|Reported Event|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
262608|NCT00997139|B1|Baseline|Treatment Group|Baseline culture positive for Staphylococcus aureus
262609|NCT00997139|P1|Participant Flow|All Subjects|
262610|NCT00997139|O1|Outcome|MRSA|Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
262611|NCT00997139|O1|Outcome|MSSA|Baseline culture positive for methicillin-susceptible staphylococcus aureus
262612|NCT00997139|O1|Outcome|All Subjects|All subjects enrolled
262613|NCT00997139|E1|Reported Event|All Subjects|
262614|NCT00997126|B3|Baseline|Total|Total of all reporting groups
262615|NCT00997126|B2|Baseline|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262616|NCT00997126|B1|Baseline|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262617|NCT00997126|P2|Participant Flow|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262618|NCT00997126|P1|Participant Flow|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262619|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262620|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262621|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262622|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262623|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262624|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262625|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262626|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262627|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262628|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262629|NCT00997126|E2|Reported Event|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
262630|NCT00997126|E1|Reported Event|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
262631|NCT00997113|B3|Baseline|Total|Total of all reporting groups
262632|NCT00997113|B2|Baseline|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
262633|NCT00997113|B1|Baseline|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262634|NCT00997113|P2|Participant Flow|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
262635|NCT00997113|P1|Participant Flow|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262636|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
262637|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262638|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
262639|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262640|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
264197|NCT00995436|B4|Baseline|Total|Total of all reporting groups
262641|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262642|NCT00997113|E2|Reported Event|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
262643|NCT00997113|E1|Reported Event|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
262644|NCT00996996|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262645|NCT00996996|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262646|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262647|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262648|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262649|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262650|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262651|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262652|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262695|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
263534|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
264322|NCT00994760|O2|Outcome|Last Visit|
262653|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262654|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262655|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262656|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262657|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262658|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262659|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262660|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262661|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262662|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262707|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262663|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262664|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262665|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262666|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262667|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262668|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262669|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262670|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262671|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262672|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262719|NCT00996944|E2|Reported Event|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262673|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262674|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262675|NCT00996996|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
262676|NCT00996944|B3|Baseline|Total|Total of all reporting groups
262677|NCT00996944|B2|Baseline|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262678|NCT00996944|B1|Baseline|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262679|NCT00996944|P2|Participant Flow|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262680|NCT00996944|P1|Participant Flow|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262681|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262682|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262683|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262746|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262747|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
263418|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
262684|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262685|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262686|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262687|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262688|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262689|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262690|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262691|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262692|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262693|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262694|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262748|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262696|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262697|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262698|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262699|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262700|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262701|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262702|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262703|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262704|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262705|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262706|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
263419|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
262708|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262709|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262710|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262711|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262712|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262713|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262714|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262715|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262716|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262717|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
262718|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
263420|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
262720|NCT00996944|E1|Reported Event|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
262721|NCT00996931|B1|Baseline|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
262722|NCT00996931|P1|Participant Flow|Lenalidomide|Six patients will receive oral 2.5 mg daily for 12 weeks
262723|NCT00996931|O1|Outcome|Lenalidomide|oral 25 mg daily for 12 weeks
262724|NCT00996931|O1|Outcome|Lenalidomide|Six subjects received oral 2.5 mg daily for 12 weeks
262725|NCT00996931|E1|Reported Event|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
262726|NCT00996918|B6|Baseline|Total|Total of all reporting groups
262727|NCT00996918|B5|Baseline|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262728|NCT00996918|B4|Baseline|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262729|NCT00996918|B3|Baseline|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262730|NCT00996918|B2|Baseline|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262731|NCT00996918|B1|Baseline|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262732|NCT00996918|P5|Participant Flow|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262733|NCT00996918|P4|Participant Flow|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262734|NCT00996918|P3|Participant Flow|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262735|NCT00996918|P2|Participant Flow|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262736|NCT00996918|P1|Participant Flow|Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262737|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262738|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262739|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262740|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262741|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262742|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262743|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262744|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262745|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
263421|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
264323|NCT00994760|O1|Outcome|Initial Visit|
262749|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262750|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262751|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262752|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262753|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262754|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262755|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262756|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262757|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262758|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262759|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262760|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262761|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262762|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262763|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262764|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262765|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262766|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262767|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262768|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262769|NCT00996918|O5|Outcome|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262770|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262771|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262772|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262773|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
263422|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
264324|NCT00994760|O2|Outcome|Last Visit|
262774|NCT00996918|E5|Reported Event|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262775|NCT00996918|E4|Reported Event|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262776|NCT00996918|E3|Reported Event|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262777|NCT00996918|E2|Reported Event|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262778|NCT00996918|E1|Reported Event|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
262779|NCT00996892|B1|Baseline|All Participants|All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262780|NCT00996892|P20|Participant Flow|S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
262781|NCT00996892|P19|Participant Flow|S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non–small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
262782|NCT00996892|P18|Participant Flow|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262783|NCT00996892|P17|Participant Flow|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262784|NCT00996892|P16|Participant Flow|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262785|NCT00996892|P15|Participant Flow|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262786|NCT00996892|P14|Participant Flow|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262787|NCT00996892|P13|Participant Flow|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262788|NCT00996892|P12|Participant Flow|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262789|NCT00996892|P11|Participant Flow|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262790|NCT00996892|P10|Participant Flow|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263423|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
264325|NCT00994760|O1|Outcome|Initial Visit|
262791|NCT00996892|P9|Participant Flow|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262792|NCT00996892|P8|Participant Flow|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262793|NCT00996892|P7|Participant Flow|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262794|NCT00996892|P6|Participant Flow|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262795|NCT00996892|P5|Participant Flow|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262796|NCT00996892|P4|Participant Flow|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262797|NCT00996892|P3|Participant Flow|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262798|NCT00996892|P2|Participant Flow|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262799|NCT00996892|P1|Participant Flow|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262800|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262801|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262802|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262803|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262804|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262805|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263424|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
264326|NCT00994760|O2|Outcome|Last Visit|
262806|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262807|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
262808|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262809|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262810|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262811|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262812|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262813|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262814|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
262815|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262816|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262817|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262818|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262819|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262820|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262821|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262822|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262823|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262824|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262825|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
262826|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262827|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262828|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262829|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262830|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262831|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262832|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
262833|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262834|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262835|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262836|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262837|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
264327|NCT00994760|O1|Outcome|Initial Visit|
262838|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262839|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262840|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262841|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262842|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262843|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
262844|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262845|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262846|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262847|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262848|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262849|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262850|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
262851|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262852|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262853|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
264328|NCT00994760|O2|Outcome|Last Visit|
262854|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262855|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262856|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262857|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262858|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262859|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262860|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262861|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262862|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262863|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262864|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262865|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262866|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262867|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262868|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262869|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262870|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262871|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262872|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262873|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262874|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262875|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262876|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262877|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262878|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262879|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262880|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262881|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262882|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262883|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262884|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262885|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262886|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262887|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262888|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262889|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262890|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262891|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262892|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262893|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262894|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262895|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262896|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262897|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262898|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262899|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262900|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262901|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262902|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262903|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262904|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262905|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262906|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262907|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262908|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262909|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262910|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262911|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262912|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262913|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262914|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262915|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262916|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262917|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262918|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262919|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262920|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262921|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262922|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262923|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262924|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262925|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262926|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262927|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262928|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262929|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262930|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262931|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262932|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262933|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262934|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262935|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262936|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262937|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262938|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262939|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262940|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262941|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262942|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262943|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262944|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262945|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262946|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262947|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262948|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262949|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262950|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262951|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262952|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262953|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262954|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262955|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262956|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262957|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262958|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262959|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262960|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262961|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262962|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262963|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262964|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262965|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262966|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262967|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262968|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262969|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262970|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262971|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262972|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262973|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262974|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263535|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
262975|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262976|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262977|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262978|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262979|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262980|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262981|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262982|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262983|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262984|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262985|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262986|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262987|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262988|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262989|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262990|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262991|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262992|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
264329|NCT00994760|O1|Outcome|Initial Visit|
264330|NCT00994760|O2|Outcome|Last Visit|
262993|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262994|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262995|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262996|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262997|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262998|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
262999|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263000|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263001|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263002|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263003|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263004|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263005|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263006|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263007|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263008|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263009|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263010|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263536|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263011|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263012|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263013|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263014|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263015|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263016|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263017|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263018|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263019|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263020|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263021|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263022|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263023|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263024|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263025|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263026|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263027|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263425|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263537|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263028|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263029|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263030|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263031|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263032|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263033|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263034|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263035|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263036|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263037|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263038|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263039|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263040|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263041|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263042|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263043|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263044|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263426|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
264331|NCT00994760|O1|Outcome|Initial Visit|
263045|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263046|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263047|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263048|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263049|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263050|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263051|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263052|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263053|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263054|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263055|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263056|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263057|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263058|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263059|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263060|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263061|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263427|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
264332|NCT00994760|O1|Outcome|Patients at First Visit|
263062|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263063|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263064|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263065|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263066|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263067|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263068|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263069|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263070|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263071|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263072|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263073|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263074|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263075|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263076|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263077|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263078|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263428|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
264333|NCT00994760|O1|Outcome|First Visit|
263079|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263080|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263081|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263082|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263083|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263084|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263085|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263086|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263087|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263088|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263089|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263090|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263091|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263092|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263093|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263094|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263095|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263096|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263429|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263097|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263098|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263099|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263100|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263101|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263102|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263103|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263104|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263105|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263106|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263107|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263108|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263109|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263110|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263111|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263112|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263113|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263114|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263430|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
264334|NCT00994760|O2|Outcome|Last Visit (LV)|
263115|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263116|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263117|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263118|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263119|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263120|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263121|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263122|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263123|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263124|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263125|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263126|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263127|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263128|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263129|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263130|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263131|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263132|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263431|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
264335|NCT00994760|O1|Outcome|Initial Visit (IV)|
263133|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263134|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263135|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263136|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263137|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263138|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263139|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263140|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263141|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263142|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263143|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263144|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263145|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263146|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263147|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263148|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263149|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263150|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263432|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
264336|NCT00994760|O1|Outcome|GENISIS|Intranasal Fentanyl Spray
263151|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263152|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263153|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263154|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263155|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263156|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263157|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263158|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263159|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263160|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263161|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263162|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263163|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263164|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263165|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263166|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263167|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263168|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263433|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
264337|NCT00994760|O1|Outcome|Physician Last Visit (LV)|
263169|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263170|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263171|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263172|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263173|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263174|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263175|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263176|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263177|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263178|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263179|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263180|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263181|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263182|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263183|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263184|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263185|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263186|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263434|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
264338|NCT00994760|O2|Outcome|Last Visit (LV)|
263187|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263188|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263189|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263190|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263191|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263192|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263193|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263194|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263195|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263196|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263197|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263198|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263199|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263200|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263201|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263202|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263203|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263204|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263435|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
271395|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
263205|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263206|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263207|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263208|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263209|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263210|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263211|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263212|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263213|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263214|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263215|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263216|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263217|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263218|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263353|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263538|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263219|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263220|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263221|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263222|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263223|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263224|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263225|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263226|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263227|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263228|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263229|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263230|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263231|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263232|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263436|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263539|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263233|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263234|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263235|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263236|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263237|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263238|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263239|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263240|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263241|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263242|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263243|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263244|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263245|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263246|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263437|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
264339|NCT00994760|O1|Outcome|First Visit (FV): Patients With Previous BTP- Medication Only|
263247|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263248|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263249|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263250|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263251|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263252|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263253|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263254|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263255|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263256|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263257|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263258|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263259|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263260|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263438|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
264340|NCT00994760|O1|Outcome|Last Visit|
263261|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263262|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263263|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263264|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263265|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263266|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263267|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263268|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263269|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263270|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263271|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263272|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263273|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263274|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263439|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
264341|NCT00994760|O2|Outcome|Last Visit|
263275|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263276|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263277|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263278|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263279|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263280|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263281|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263282|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263283|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263284|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263285|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263286|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263287|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263288|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263440|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
264342|NCT00994760|O1|Outcome|Initial Visit|
263289|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263290|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263291|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263292|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263293|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263294|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263295|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263296|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263297|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263298|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263299|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263300|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263301|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263302|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263441|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
264343|NCT00994760|O2|Outcome|Study End|
264344|NCT00994760|O1|Outcome|Study Start|
263303|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263304|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263305|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263306|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263307|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263308|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263309|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263310|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263311|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263312|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263313|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263314|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263315|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263316|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263442|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
264345|NCT00994760|E1|Reported Event|All Patients Treated|
263317|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263318|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263319|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263320|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263321|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263322|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263323|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263324|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263325|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263326|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263327|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263328|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263329|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263330|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263443|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
265473|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
263331|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263332|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263333|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263334|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263335|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263336|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263337|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263338|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263339|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263340|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263354|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263341|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263342|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263343|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263344|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263345|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263346|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263347|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263348|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263349|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263350|NCT00996892|O1|Outcome|All Participants - Stages 1, 1A, 1B|All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263351|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263352|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263355|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263356|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263357|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263358|NCT00996892|O11|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263359|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263360|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263361|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263362|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263363|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263364|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263365|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263366|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263367|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263368|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263369|NCT00996892|E18|Reported Event|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263370|NCT00996892|E17|Reported Event|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263414|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263371|NCT00996892|E16|Reported Event|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263372|NCT00996892|E15|Reported Event|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263373|NCT00996892|E14|Reported Event|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263374|NCT00996892|E13|Reported Event|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263375|NCT00996892|E12|Reported Event|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263376|NCT00996892|E11|Reported Event|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
263377|NCT00996892|E10|Reported Event|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263378|NCT00996892|E9|Reported Event|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263379|NCT00996892|E8|Reported Event|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263380|NCT00996892|E7|Reported Event|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263381|NCT00996892|E6|Reported Event|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263382|NCT00996892|E5|Reported Event|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263383|NCT00996892|E4|Reported Event|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
263384|NCT00996892|E3|Reported Event|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263385|NCT00996892|E2|Reported Event|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263415|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263416|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263417|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263523|NCT00996736|O2|Outcome|Topical Voriconazole|
263386|NCT00996892|E1|Reported Event|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
263387|NCT00996801|B7|Baseline|Total|Total of all reporting groups
263388|NCT00996801|B6|Baseline|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263389|NCT00996801|B5|Baseline|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263390|NCT00996801|B4|Baseline|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263391|NCT00996801|B3|Baseline|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263392|NCT00996801|B2|Baseline|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263393|NCT00996801|B1|Baseline|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263394|NCT00996801|P6|Participant Flow|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263395|NCT00996801|P5|Participant Flow|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263396|NCT00996801|P4|Participant Flow|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263397|NCT00996801|P3|Participant Flow|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263398|NCT00996801|P2|Participant Flow|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263399|NCT00996801|P1|Participant Flow|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263400|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263401|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
263402|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263403|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263404|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263405|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263406|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263407|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
263408|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263409|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263410|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263411|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263412|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263413|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
263444|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263445|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263446|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263447|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263448|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263449|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263450|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263451|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263452|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263453|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263454|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263455|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263456|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263457|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263458|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263459|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263460|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263461|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263462|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263463|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263464|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263465|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263466|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263467|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263468|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263469|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263470|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263471|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263472|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263473|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263474|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263475|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263476|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263477|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263478|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263479|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263480|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263481|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263524|NCT00996736|O1|Outcome|Topical Natamycin|
263525|NCT00996736|O2|Outcome|Topical Voriconazole|
263482|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263483|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263484|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263485|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263486|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263487|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263488|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
263489|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
263490|NCT00996801|O3|Outcome|MK-5442 7.5mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
263491|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
263492|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
263493|NCT00996801|E6|Reported Event|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263494|NCT00996801|E5|Reported Event|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263495|NCT00996801|E4|Reported Event|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263496|NCT00996801|E3|Reported Event|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263497|NCT00996801|E2|Reported Event|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263498|NCT00996801|E1|Reported Event|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
263499|NCT00996775|B3|Baseline|Total|Total of all reporting groups
263500|NCT00996775|B2|Baseline|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263501|NCT00996775|B1|Baseline|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263502|NCT00996775|P2|Participant Flow|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263503|NCT00996775|P1|Participant Flow|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263504|NCT00996775|O2|Outcome|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263505|NCT00996775|O1|Outcome|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263506|NCT00996775|E2|Reported Event|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263507|NCT00996775|E1|Reported Event|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
263508|NCT00996736|B3|Baseline|Total|Total of all reporting groups
263509|NCT00996736|B2|Baseline|Topical Voriconazole|
263510|NCT00996736|B1|Baseline|Topical Natamycin|
263511|NCT00996736|P2|Participant Flow|Topical Voriconazole|
263512|NCT00996736|P1|Participant Flow|Topical Natamycin|
263513|NCT00996736|O2|Outcome|Topical Voriconazole|
263514|NCT00996736|O1|Outcome|Topical Natamycin|
263515|NCT00996736|O2|Outcome|Topical Voriconazole|
263516|NCT00996736|O1|Outcome|Topical Natamycin|
263517|NCT00996736|O2|Outcome|Topical Voriconazole|
263518|NCT00996736|O1|Outcome|Topical Natamycin|
263519|NCT00996736|O2|Outcome|Topical Voriconazole|
263520|NCT00996736|O1|Outcome|Topical Natamycin|
263521|NCT00996736|O2|Outcome|Topical Voriconazole|
263522|NCT00996736|O1|Outcome|Topical Natamycin|
263540|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263541|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263542|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263543|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263544|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263545|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263546|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263547|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263548|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263549|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263550|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263551|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263552|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263553|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263554|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263555|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263556|NCT00996658|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
263557|NCT00996658|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
263558|NCT00996632|B3|Baseline|Total|Total of all reporting groups
263559|NCT00996632|B2|Baseline|Conventional|Patients were operated by a conventional diatherm knife
263560|NCT00996632|B1|Baseline|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
263561|NCT00996632|P2|Participant Flow|Conventional|Patients were operated by a conventional diatherm knife
263562|NCT00996632|P1|Participant Flow|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
263563|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
263564|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
263565|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
263566|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
263567|NCT00996632|E2|Reported Event|Conventional|Patients were operated by a conventional diatherm knife
263568|NCT00996632|E1|Reported Event|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
263569|NCT00996606|B1|Baseline|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263570|NCT00996606|P1|Participant Flow|Tocilizumab in Active Rheumatoid Arthritis (RA)|Participants with active RA received tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263571|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263572|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263573|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263574|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263575|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263576|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263577|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263578|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263579|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263580|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263581|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263582|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263701|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263583|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263584|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263585|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263586|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263587|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263588|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263589|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263590|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263591|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263592|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263593|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263594|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263595|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263596|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263597|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263598|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263599|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263600|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263601|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263602|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263603|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263604|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263605|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263606|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263607|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263608|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263609|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263610|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263744|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
263611|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263612|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263613|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263614|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263615|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263616|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263617|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263618|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263619|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263620|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263621|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263622|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263623|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263624|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263625|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263626|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263627|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263628|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263629|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263630|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263631|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263632|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263633|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263634|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263635|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263636|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263637|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263638|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263826|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
263639|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263640|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263641|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263642|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263643|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263644|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263645|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263646|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263647|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263648|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263649|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263650|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263651|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263652|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263653|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263654|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263655|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263656|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263657|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263658|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263659|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263660|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263661|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263662|NCT00996606|E1|Reported Event|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
263663|NCT00996593|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263699|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
265474|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
263664|NCT00996593|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263665|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263666|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263667|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263668|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263669|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263670|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263671|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263672|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263673|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
271396|NCT00975637|E5|Reported Event|Broda 70 mg|AMG 827: 70 mg SC
263674|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263675|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263676|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263677|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263678|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263679|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263680|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263681|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263682|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263683|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
271397|NCT00975637|E4|Reported Event|Placebo|Placebo: Placebo SC
263684|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263685|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263686|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263687|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263688|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263689|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263690|NCT00996593|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
263691|NCT00996580|B1|Baseline|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263692|NCT00996580|P1|Participant Flow|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263693|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263694|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263695|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263696|NCT00996580|O1|Outcome|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263697|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263698|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263700|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
264072|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
263702|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263703|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263704|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263705|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263706|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263707|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263708|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263709|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263710|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263711|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263712|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263713|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263714|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263715|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
263716|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
263717|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263718|NCT00996580|E1|Reported Event|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
263719|NCT00996502|B1|Baseline|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
263720|NCT00996502|P1|Participant Flow|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
263721|NCT00996502|O1|Outcome|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
263745|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263746|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263722|NCT00996502|E1|Reported Event|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
263723|NCT00996476|B6|Baseline|Total|Total of all reporting groups
263724|NCT00996476|B5|Baseline|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263725|NCT00996476|B4|Baseline|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263726|NCT00996476|B3|Baseline|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263727|NCT00996476|B2|Baseline|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263728|NCT00996476|B1|Baseline|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263729|NCT00996476|P5|Participant Flow|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263730|NCT00996476|P4|Participant Flow|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263731|NCT00996476|P3|Participant Flow|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263732|NCT00996476|P2|Participant Flow|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263733|NCT00996476|P1|Participant Flow|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263734|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263735|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263736|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263737|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263738|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263739|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
263740|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
263741|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
263742|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
263743|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
263747|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263748|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263749|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263750|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263751|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263752|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263753|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263754|NCT00996476|O6|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263755|NCT00996476|O5|Outcome|All TMC435|TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks
263756|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263757|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263758|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263759|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263760|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263761|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263762|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263763|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263764|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263765|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263766|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263822|NCT00996372|B2|Baseline|Placebo|
263823|NCT00996372|B1|Baseline|Flibanserin|
271398|NCT00975637|E3|Reported Event|Broda 280 mg|AMG 827: 280 mg SC
263767|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263768|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263769|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263770|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263771|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263772|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263773|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263774|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263775|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263776|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263777|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263778|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263779|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263780|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263781|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263782|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263783|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263784|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263785|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263824|NCT00996372|P2|Participant Flow|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
263825|NCT00996372|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
263786|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263787|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263788|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263789|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263790|NCT00996476|O3|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263791|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
263792|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
263793|NCT00996476|E5|Reported Event|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
263794|NCT00996476|E4|Reported Event|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263795|NCT00996476|E3|Reported Event|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
263796|NCT00996476|E2|Reported Event|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263797|NCT00996476|E1|Reported Event|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
263798|NCT00996437|B3|Baseline|Total|Total of all reporting groups
263799|NCT00996437|B2|Baseline|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263800|NCT00996437|B1|Baseline|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263801|NCT00996437|P2|Participant Flow|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263802|NCT00996437|P1|Participant Flow|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263803|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263804|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263805|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263806|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263807|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263808|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263809|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263810|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263811|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263812|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263813|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263814|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263815|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263816|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263817|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263818|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263819|NCT00996437|E2|Reported Event|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
263820|NCT00996437|E1|Reported Event|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
263821|NCT00996372|B3|Baseline|Total|Total of all reporting groups
263827|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
263828|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
263829|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
263830|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
263831|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
263832|NCT00996372|E2|Reported Event|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
263833|NCT00996372|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
263834|NCT00996346|B4|Baseline|Total|Total of all reporting groups
263835|NCT00996346|B3|Baseline|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
263836|NCT00996346|B2|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263837|NCT00996346|B1|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263838|NCT00996346|P3|Participant Flow|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
263839|NCT00996346|P2|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263840|NCT00996346|P1|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263841|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
263842|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
263843|NCT00996346|E3|Reported Event|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
263844|NCT00996346|E2|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263845|NCT00996346|E1|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
263846|NCT00996333|B1|Baseline|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263847|NCT00996333|P1|Participant Flow|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263848|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263849|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263850|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263897|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263898|NCT00996307|O3|Outcome|7.5_(50)MF59-No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
264132|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
263851|NCT00996333|E1|Reported Event|Gemzar, Taxotere, Xeloda|"Gemcitabine, Docetaxel, Capecitabine:~Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
263852|NCT00996307|B5|Baseline|Total|Total of all reporting groups
263853|NCT00996307|B4|Baseline|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263854|NCT00996307|B3|Baseline|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263855|NCT00996307|B2|Baseline|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263856|NCT00996307|B1|Baseline|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263857|NCT00996307|P4|Participant Flow|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263858|NCT00996307|P3|Participant Flow|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263859|NCT00996307|P2|Participant Flow|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263860|NCT00996307|P1|Participant Flow|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263861|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263862|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263863|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263864|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263865|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263866|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263867|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263868|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263869|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263870|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263871|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263872|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263873|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263874|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263875|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263876|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263877|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263878|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263879|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263880|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263881|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263882|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263883|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263884|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263885|NCT00996307|O8|Outcome|15_(0)MF59-with Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263886|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263887|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263888|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263889|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263890|NCT00996307|O3|Outcome|7.5_(50)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263891|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263892|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263893|NCT00996307|O8|Outcome|15_(0)MF59-Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263894|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263895|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263896|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263899|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263900|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263901|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263902|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263903|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263904|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263905|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263906|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263907|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263908|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263909|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263910|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263911|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263912|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263913|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263914|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263915|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263916|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263917|NCT00996307|E4|Reported Event|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263918|NCT00996307|E3|Reported Event|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263919|NCT00996307|E2|Reported Event|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
263920|NCT00996307|E1|Reported Event|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
263921|NCT00996281|B3|Baseline|Total|Total of all reporting groups
263922|NCT00996281|B2|Baseline|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263923|NCT00996281|B1|Baseline|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263924|NCT00996281|P2|Participant Flow|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263925|NCT00996281|P1|Participant Flow|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263926|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263927|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263972|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
263973|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
263974|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
264194|NCT00995449|E3|Reported Event|KB003 600 mg|600 mg, KB003 a monoclonal antibody
263928|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263929|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263930|NCT00996281|E2|Reported Event|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263931|NCT00996281|E1|Reported Event|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
263932|NCT00996216|B1|Baseline|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263933|NCT00996216|P1|Participant Flow|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263934|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263935|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263936|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263975|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
263937|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263938|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263939|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263940|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263941|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263942|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263943|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263976|NCT00996164|E2|Reported Event|Placebo|placebo 1 tab po qd
263977|NCT00996164|E1|Reported Event|Flibanserin 100 mg|flibanserin 100mg po qd
263978|NCT00996125|B3|Baseline|Total|Total of all reporting groups
263979|NCT00996125|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
264195|NCT00995449|E2|Reported Event|KB003 200 mg|Dose group not evaluated in this portion of study
263944|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263945|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263946|NCT00996216|E2|Reported Event|Eltrombopag (Part 2)|Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
263947|NCT00996216|E1|Reported Event|Eltrombopag (Part 1)|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.
263948|NCT00996203|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263949|NCT00996203|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263950|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263951|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263952|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263953|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263954|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263955|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263956|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263957|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263958|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263959|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263960|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263961|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263962|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263963|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263964|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263965|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263966|NCT00996203|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
263967|NCT00996164|B3|Baseline|Total|Total of all reporting groups
263968|NCT00996164|B2|Baseline|Placebo|placebo 1 tab po qd
263969|NCT00996164|B1|Baseline|Flibanserin 100 mg|flibanserin 100mg po qd
263970|NCT00996164|P2|Participant Flow|Placebo|placebo 1 tab po qd
263971|NCT00996164|P1|Participant Flow|Flibanserin 100 mg|flibanserin 100mg po qd
264019|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
263980|NCT00996125|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263981|NCT00996125|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263982|NCT00996125|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263983|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263984|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263985|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263986|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263987|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263988|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263989|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263990|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263991|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263992|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263993|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263994|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263995|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263996|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263997|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263998|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
263999|NCT00996125|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
264000|NCT00996125|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
264001|NCT00996034|B1|Baseline|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
264002|NCT00996034|P1|Participant Flow|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
264003|NCT00996034|O1|Outcome|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
264004|NCT00996034|E1|Reported Event|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
264005|NCT00995930|B3|Baseline|Total|Total of all reporting groups
264006|NCT00995930|B2|Baseline|ACZ885|150 mg SQ monthly
264007|NCT00995930|B1|Baseline|Placebo|SQ monthly
264008|NCT00995930|P2|Participant Flow|ACZ885|150 mg SQ monthly
264009|NCT00995930|P1|Participant Flow|Placebo|SQ monthly
264010|NCT00995930|O1|Outcome|ACZ885|150 mg SQ monthly
264011|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
264012|NCT00995930|O1|Outcome|Placebo|SQ monthly
264013|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
264014|NCT00995930|O1|Outcome|Placebo|SQ monthly
264015|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
264016|NCT00995930|O1|Outcome|Placebo|SQ monthly
264017|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
264018|NCT00995930|O1|Outcome|Placebo|SQ monthly
264038|NCT00995904|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264039|NCT00995904|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264040|NCT00995904|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264041|NCT00995904|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264042|NCT00995904|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264043|NCT00995904|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
264044|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264045|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264046|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264047|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264048|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264049|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264050|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
264051|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
264052|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
264053|NCT00995904|E3|Reported Event|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264054|NCT00995904|E2|Reported Event|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264055|NCT00995904|E1|Reported Event|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
264056|NCT00995865|B4|Baseline|Total|Total of all reporting groups
264057|NCT00995865|B3|Baseline|Placebo Group|This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection).
264058|NCT00995865|B2|Baseline|Mid-Dose Group|Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group.
264059|NCT00995865|B1|Baseline|High Dose Group|Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose).
264060|NCT00995865|P3|Participant Flow|Placebo|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
264061|NCT00995865|P2|Participant Flow|Mid Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264062|NCT00995865|P1|Participant Flow|High Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264063|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
264064|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264065|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
264066|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
264067|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264068|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264069|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
264070|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264071|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
271399|NCT00975637|E2|Reported Event|Broda 140 mg|AMG 827: 140 mg SC
264073|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
264074|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
264075|NCT00995865|E6|Reported Event|Placebo Second Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% Second injection."
264076|NCT00995865|E5|Reported Event|Mid Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection."
264077|NCT00995865|E4|Reported Event|High Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection at an interval of 21 days"
264078|NCT00995865|E3|Reported Event|Placebo First Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% First injection."
264079|NCT00995865|E2|Reported Event|Mid Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
264080|NCT00995865|E1|Reported Event|High Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
264081|NCT00995774|B3|Baseline|Total|Total of all reporting groups
264082|NCT00995774|B2|Baseline|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
264083|NCT00995774|B1|Baseline|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
264084|NCT00995774|P2|Participant Flow|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
264085|NCT00995774|P1|Participant Flow|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
264086|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
264087|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
264088|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
264089|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
264090|NCT00995774|E2|Reported Event|Arm 2|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
264091|NCT00995774|E1|Reported Event|Arm 1|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
264092|NCT00995761|B1|Baseline|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
264093|NCT00995761|P1|Participant Flow|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
264094|NCT00995761|O1|Outcome|Biweekly Schedule of Docetaxel and Cisplatin|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
264095|NCT00995761|E1|Reported Event|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
264096|NCT00995722|B3|Baseline|Total|Total of all reporting groups
264097|NCT00995722|B2|Baseline|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264098|NCT00995722|B1|Baseline|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264099|NCT00995722|P2|Participant Flow|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264100|NCT00995722|P1|Participant Flow|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264101|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264102|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264103|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264104|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264105|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264106|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264107|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264108|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264109|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264110|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264111|NCT00995722|E2|Reported Event|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264112|NCT00995722|E1|Reported Event|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
264113|NCT00995709|B4|Baseline|Total|Total of all reporting groups
264114|NCT00995709|B3|Baseline|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264115|NCT00995709|B2|Baseline|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264116|NCT00995709|B1|Baseline|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264117|NCT00995709|P3|Participant Flow|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264118|NCT00995709|P2|Participant Flow|AIN457C 300 mg Monthly Dosage Regimen|"AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.~One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication"
264119|NCT00995709|P1|Participant Flow|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264120|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264121|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264122|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264123|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264124|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264125|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264126|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264127|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264128|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264129|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264130|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264131|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
271400|NCT00975637|E1|Reported Event|Broda 210 mg|AMG 827: 210 mg SC
264133|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264134|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264135|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
264136|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
264137|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264138|NCT00995709|E3|Reported Event|Placebo|Placebo was administered in 2 s.c. injections
264139|NCT00995709|E2|Reported Event|AIN457 300mg Monthly|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264140|NCT00995709|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
264141|NCT00995670|B4|Baseline|Total|Total of all reporting groups
264142|NCT00995670|B3|Baseline|Statin and Glucose|"Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Statin: 40 mg of simvastatin 17 volunteers were studied 31 times in this arm."
264143|NCT00995670|B2|Baseline|Vitamin C and Glucose|"To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Vitamin C: 1 gm iv bolus injection 5 min before I/R injury 16 volunteers were studied 25 times in this arm."
264144|NCT00995670|B1|Baseline|Sevoflurane and Glucose|"Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent I/R injury.~Sevoflurane: 1 minimum alveolar concentration (MAC) for 20 min (after hour of glucose and before I/R) 26 volunteers were studied 67 times in this arm."
264145|NCT00995670|P3|Participant Flow|Statin and Glucose|Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
264146|NCT00995670|P2|Participant Flow|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
264147|NCT00995670|P1|Participant Flow|Sevoflurane and Glucose|Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
264148|NCT00995670|O3|Outcome|Statin and Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
264149|NCT00995670|O2|Outcome|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
264150|NCT00995670|O1|Outcome|Sevoflurane and Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
264151|NCT00995670|E3|Reported Event|Statins & Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
264152|NCT00995670|E2|Reported Event|Vitamin C & Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
264153|NCT00995670|E1|Reported Event|Sevoflurane & Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
264154|NCT00995566|B1|Baseline|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264155|NCT00995566|P1|Participant Flow|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264156|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264157|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264158|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264159|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264160|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264161|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264162|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264163|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264164|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264165|NCT00995566|E1|Reported Event|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
264166|NCT00995553|B3|Baseline|Total|Total of all reporting groups
264167|NCT00995553|B2|Baseline|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
264168|NCT00995553|B1|Baseline|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
264169|NCT00995553|P2|Participant Flow|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
264170|NCT00995553|P1|Participant Flow|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
264171|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
264172|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
264173|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
264174|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
264175|NCT00995553|E2|Reported Event|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
264176|NCT00995553|E1|Reported Event|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
264177|NCT00995488|B1|Baseline|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
264178|NCT00995488|P1|Participant Flow|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
264179|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
264180|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
264181|NCT00995488|E1|Reported Event|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
264182|NCT00995449|B5|Baseline|Total|Total of all reporting groups
264183|NCT00995449|B4|Baseline|Placebo|Placebo comparator
264184|NCT00995449|B3|Baseline|KB003 600 mg|600 mg, KB003 a monoclonal antibody
264185|NCT00995449|B2|Baseline|KB003 200 mg|Dose group not evaluated in this portion of study
264186|NCT00995449|B1|Baseline|KB003 70mg|Dose group not evaluated in this portion of study
264187|NCT00995449|P4|Participant Flow|Placebo|Placebo comparator
264188|NCT00995449|P3|Participant Flow|KB003 600 mg|600 mg, KB003 a monoclonal antibody
264189|NCT00995449|P2|Participant Flow|KB003 200 mg|Dose group not evaluated in this portion of study
264190|NCT00995449|P1|Participant Flow|KB003 70mg|Dose group not evaluated in this portion of study
264191|NCT00995449|O2|Outcome|Placebo|Placebo comparator
264192|NCT00995449|O1|Outcome|KB003 600 mg|600 mg, KB003 a monoclonal antibody
264193|NCT00995449|E4|Reported Event|Placebo|Placebo comparator
264198|NCT00995436|B3|Baseline|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
264199|NCT00995436|B2|Baseline|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
264200|NCT00995436|B1|Baseline|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
264201|NCT00995436|P3|Participant Flow|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
264202|NCT00995436|P2|Participant Flow|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
264203|NCT00995436|P1|Participant Flow|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
264204|NCT00995436|O3|Outcome|Headgear|
264205|NCT00995436|O2|Outcome|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
264206|NCT00995436|O1|Outcome|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
264207|NCT00995436|E3|Reported Event|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
264208|NCT00995436|E2|Reported Event|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
264209|NCT00995436|E1|Reported Event|Headgear|"Device Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage: Extra oral anchorage"
264210|NCT00995410|B1|Baseline|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
264211|NCT00995410|P1|Participant Flow|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
264212|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
264213|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
264214|NCT00995410|E1|Reported Event|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
264215|NCT00995371|B3|Baseline|Total|Total of all reporting groups
264216|NCT00995371|B2|Baseline|Epidural Steroid Injection|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
264217|NCT00995371|B1|Baseline|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264218|NCT00995371|P2|Participant Flow|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
264219|NCT00995371|P1|Participant Flow|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264220|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
264221|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264222|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
264223|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264224|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
264225|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264226|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
264227|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264228|NCT00995371|E3|Reported Event|ESI Cross-over to Lumbar Decompression With Mild|Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
264229|NCT00995371|E2|Reported Event|Epidural Steroid Injection|"Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.~The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure"
264230|NCT00995371|E1|Reported Event|Vertos Mild® Minimally-Invasive Lumbar Decompression|Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
264231|NCT00995345|B6|Baseline|Total|Total of all reporting groups
264232|NCT00995345|B5|Baseline|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264233|NCT00995345|B4|Baseline|Dose 3: KRP-104|100 mg QD
264234|NCT00995345|B3|Baseline|Dose 2: KRP-104|80 mg QD
264235|NCT00995345|B2|Baseline|Dose 1: KRP-104|40 mg QD
264236|NCT00995345|B1|Baseline|Placebo|Tablet
264237|NCT00995345|P5|Participant Flow|Dose 4: KRP-104|20 mg /120 mg QD (dose switch at week12)
264238|NCT00995345|P4|Participant Flow|Dose 3: KRP-104|100 mg QD
264239|NCT00995345|P3|Participant Flow|Dose 2: KRP-104|80 mg QD
264240|NCT00995345|P2|Participant Flow|Dose 1: KRP-104|40 mg QD
264241|NCT00995345|P1|Participant Flow|Placebo|Tablet
264242|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264243|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
264244|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
264245|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
264246|NCT00995345|O1|Outcome|Placebo|Tablet
264247|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264248|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
264249|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
264250|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
264251|NCT00995345|O1|Outcome|Placebo|Tablet
264252|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264253|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
264254|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
264255|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
264256|NCT00995345|O1|Outcome|Placebo|Tablet
264257|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264258|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
264259|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
264260|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
264261|NCT00995345|O1|Outcome|Placebo|Tablet
264262|NCT00995345|E5|Reported Event|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
264263|NCT00995345|E4|Reported Event|Dose 3: KRP-104|100 mg QD
264264|NCT00995345|E3|Reported Event|Dose 2: KRP-104|80 mg QD
264265|NCT00995345|E2|Reported Event|Dose 1: KRP-104|40 mg QD
264266|NCT00995345|E1|Reported Event|Placebo|Tablet
264267|NCT00995085|B1|Baseline|Metadoxine IR/SR|Metadoxine is a pyrolate salt of Pyridoxine
264268|NCT00995085|P1|Participant Flow|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
264269|NCT00995085|O1|Outcome|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
264270|NCT00995085|E1|Reported Event|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
264271|NCT00995020|B3|Baseline|Total|Total of all reporting groups
264272|NCT00995020|B2|Baseline|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
264273|NCT00995020|B1|Baseline|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
264274|NCT00995020|P2|Participant Flow|LLETZ Cone: Large Loop Excision of Transformation Zone - Cone|The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
264275|NCT00995020|P1|Participant Flow|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
264276|NCT00995020|O2|Outcome|SWETZ|SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision.
264277|NCT00995020|O1|Outcome|LLETZ - Cone|LLETZ - cone was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
264278|NCT00995020|O2|Outcome|LLETZ Cone|LLETZ cone,the standard procedure is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
264279|NCT00995020|O1|Outcome|SWETZ|SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
272938|NCT00970853|O1|Outcome|Control|Control group
264280|NCT00995020|E2|Reported Event|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
264281|NCT00995020|E1|Reported Event|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
264282|NCT00995007|B3|Baseline|Total|Total of all reporting groups
264283|NCT00995007|B2|Baseline|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264284|NCT00995007|B1|Baseline|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264285|NCT00995007|P2|Participant Flow|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264286|NCT00995007|P1|Participant Flow|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264287|NCT00995007|O3|Outcome|Cross Over to Vandetanib|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264288|NCT00995007|O2|Outcome|Vandetanib With Carboplatin|"Sequential Group (carboplatin followed by vandetanib)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264289|NCT00995007|O1|Outcome|Carboplatin|"Combo Group (both drugs together)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264290|NCT00995007|O4|Outcome|Anaplastic Astrocytoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264291|NCT00995007|O3|Outcome|Anaplastic Astrocytoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264292|NCT00995007|O2|Outcome|Glioblastoma (Carboplation Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264293|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264346|NCT00994604|B1|Baseline|Broccoli Sprout Extract|broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
264347|NCT00994604|P1|Participant Flow|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
264294|NCT00995007|O4|Outcome|Anaplastic Astrocytomas (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264295|NCT00995007|O3|Outcome|Anaplastic Astrocytomas (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264296|NCT00995007|O2|Outcome|Glioblastoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264297|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264298|NCT00995007|E3|Reported Event|Crossover to Vandetanib|ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
264299|NCT00995007|E2|Reported Event|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
264300|NCT00995007|E1|Reported Event|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
264301|NCT00994929|B1|Baseline|Neumega (Oprelveken, Interleukin 11)|The VWD subjects included two with type 1 VWD and two with type 2 VWD, including one with type 2B, with increased platelet aggregation at low strength ristocetin and absent high molecular weight multimers, and one with type 2M disease, with reduced VWF:RCoF/ VWF:Ag ratio <0.50, per NHLBI criteria (Table 2).5 All subjects had positive past bleeding histories. Pregnancy, lactation, heart disease, uncontrolled hypertension, arrhythmia, thrombosis, recent surgery or receipt of blood products were exclusions. A total of nine subjects were enrolled and completed study, including five with hemophilia A and four with VWD. The median age was 26 years, range 22-51 years
264302|NCT00994929|P1|Participant Flow|Neumega (Oprelveken, Interleukin 11)|25 µg/kilogram of body weight of rhIL-11 subcutaneously administered on days 1 to 4. On day 4 following rhIL-11 injection DDAVP was subsequently given at 0.3 mcg/kg intravenously over 30 minutes. For any subject with past allergic reactions, hypersensitivity, or seizures with DDAVP, or in whom DDAVP is contraindicated, DDAVP was not given: only rhIL-11 was given on Day 4.
264303|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
264304|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
264305|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
264306|NCT00994929|E1|Reported Event|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion.
264307|NCT00994760|B1|Baseline|GENISIS|Intranasal Fentanyl Spray
264308|NCT00994760|P1|Participant Flow|GENISIS|Intranasal Fentanyl Spray
264309|NCT00994760|O1|Outcome|Caregiver at Final Visit|
264310|NCT00994760|O1|Outcome|Caregiver at Final Visit|
264311|NCT00994760|O1|Outcome|Caregiver at Final Visit|
264312|NCT00994760|O1|Outcome|Caregiver at Final Visit|
264313|NCT00994760|O1|Outcome|Patients at Final Visit|
264314|NCT00994760|O1|Outcome|Patients at Final Visit|
264315|NCT00994760|O2|Outcome|Last Visit (LV)|
264316|NCT00994760|O1|Outcome|First Visit (FV)(Patients With Previous BTP-medication Only)|
264317|NCT00994760|O1|Outcome|Patients at Final Visit|
264318|NCT00994760|O2|Outcome|Last Visit|
264319|NCT00994760|O1|Outcome|Initial Visit|
264320|NCT00994760|O2|Outcome|Last Visit|
264321|NCT00994760|O1|Outcome|Initial Visit|
264348|NCT00994604|O2|Outcome|Airway Size Post BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
264349|NCT00994604|O1|Outcome|Airway Size Pre BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
264350|NCT00994604|O2|Outcome|Broccoli Sprout Extract - BD|pre- and post-consumption of broccoli sprout extract for 2 weeks
264351|NCT00994604|O1|Outcome|Broccoli Sprout Extract - BP|pre- and post-consumption of broccoli sprout extract for 2 weeks
264352|NCT00994604|E1|Reported Event|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
264353|NCT00994461|B4|Baseline|Total|Total of all reporting groups
264354|NCT00994461|B3|Baseline|Placebo|Placebo tablet three times a day with meal for 2 weeks
264355|NCT00994461|B2|Baseline|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264356|NCT00994461|B1|Baseline|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264357|NCT00994461|P3|Participant Flow|Placebo|Placebo tablet three times a day with meal for 2 weeks
264358|NCT00994461|P2|Participant Flow|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264359|NCT00994461|P1|Participant Flow|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264360|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264361|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264362|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264363|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264364|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264365|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264366|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264367|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264368|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264369|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264370|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264371|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264372|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264373|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264374|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264375|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264376|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264377|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264378|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
264379|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264380|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264381|NCT00994461|E3|Reported Event|Placebo|Placebo tablet three times a day with meal for 2 weeks
264382|NCT00994461|E2|Reported Event|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
264383|NCT00994461|E1|Reported Event|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
264384|NCT00994448|B3|Baseline|Total|Total of all reporting groups
264385|NCT00994448|B2|Baseline|Placebo (Sugar Pill)|Matching placebo tablets twice a day
264386|NCT00994448|B1|Baseline|Bupropion|Bupropion SR 150 mg twice a day
264387|NCT00994448|P2|Participant Flow|Placebo (Sugar Pill)|Matching placebo tablets twice a day
264388|NCT00994448|P1|Participant Flow|Bupropion|Bupropion SR 150 mg twice a day
264389|NCT00994448|O2|Outcome|Placebo (Sugar Pill)|Matching placebo tablets twice a day
264390|NCT00994448|O1|Outcome|Bupropion|Bupropion SR 150 mg twice a day
264391|NCT00994448|E2|Reported Event|Placebo (Sugar Pill)|Matching placebo tablets twice a day
264392|NCT00994448|E1|Reported Event|Bupropion|Bupropion SR 150 mg twice a day
264393|NCT00994422|B3|Baseline|Total|Total of all reporting groups
264394|NCT00994422|B2|Baseline|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
264395|NCT00994422|B1|Baseline|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
264396|NCT00994422|P2|Participant Flow|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
264397|NCT00994422|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
264398|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
264399|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
264400|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
264401|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
264402|NCT00994422|O2|Outcome|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
264403|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
264404|NCT00994422|E2|Reported Event|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
264405|NCT00994422|E1|Reported Event|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
264406|NCT00994318|B4|Baseline|Total|Total of all reporting groups
264407|NCT00994318|B3|Baseline|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
264408|NCT00994318|B2|Baseline|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
264409|NCT00994318|B1|Baseline|FCM (High Ferritin Target|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
264410|NCT00994318|P3|Participant Flow|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
264411|NCT00994318|P2|Participant Flow|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
264412|NCT00994318|P1|Participant Flow|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
264413|NCT00994318|O3|Outcome|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
264414|NCT00994318|O2|Outcome|FCM (Low Ferritin Level)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
264415|NCT00994318|O1|Outcome|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
264416|NCT00994318|E3|Reported Event|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
264417|NCT00994318|E2|Reported Event|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
264418|NCT00994318|E1|Reported Event|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
264419|NCT00994253|B3|Baseline|Total|Total of all reporting groups
264420|NCT00994253|B2|Baseline|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
264421|NCT00994253|B1|Baseline|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
264422|NCT00994253|P2|Participant Flow|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
264423|NCT00994253|P1|Participant Flow|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
264424|NCT00994253|O2|Outcome|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
264425|NCT00994253|O1|Outcome|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
264426|NCT00994253|E2|Reported Event|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
264427|NCT00994253|E1|Reported Event|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
264428|NCT00994240|B3|Baseline|Total|Total of all reporting groups
264429|NCT00994240|B2|Baseline|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264430|NCT00994240|B1|Baseline|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264431|NCT00994240|P2|Participant Flow|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264432|NCT00994240|P1|Participant Flow|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264433|NCT00994240|O2|Outcome|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264434|NCT00994240|O1|Outcome|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264435|NCT00994240|E2|Reported Event|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264436|NCT00994240|E1|Reported Event|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
264437|NCT00994214|B5|Baseline|Total|Total of all reporting groups
264438|NCT00994214|B4|Baseline|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections..
264439|NCT00994214|B3|Baseline|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264440|NCT00994214|B2|Baseline|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264441|NCT00994214|B1|Baseline|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264442|NCT00994214|P4|Participant Flow|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264443|NCT00994214|P3|Participant Flow|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264444|NCT00994214|P2|Participant Flow|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264445|NCT00994214|P1|Participant Flow|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264446|NCT00994214|O9|Outcome|Overall - Part B|
264447|NCT00994214|O8|Outcome|Part B: Arm D: BIM 23A760 6 mg|
264448|NCT00994214|O7|Outcome|Part B: Arm C: BIM 23A760 4 mg|
264449|NCT00994214|O6|Outcome|Part B: Arm B: BIM 23A760 2 mg|
264450|NCT00994214|O5|Outcome|Overall - Part A|
264451|NCT00994214|O4|Outcome|Part A: Arm D: BIM 23A760 6 mg|
264452|NCT00994214|O3|Outcome|Part A: Arm C: BIM 23A760 4 mg|
264453|NCT00994214|O2|Outcome|Part A: Arm B: BIM 23A760 2 mg|
264454|NCT00994214|O1|Outcome|Part A: Arm A: BIM 23A760 1 mg|
264455|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264456|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264457|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264458|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264459|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264460|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264461|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264462|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264463|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264464|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
264465|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections
264466|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections
264467|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections
264468|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
264469|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264470|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264471|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264472|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264473|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264474|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264475|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
264476|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
264477|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
264478|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
264479|NCT00994214|E9|Reported Event|Overall - Part B|
264480|NCT00994214|E8|Reported Event|Part B: Arm D: BIM 23A760 6 mg|
264481|NCT00994214|E7|Reported Event|Part B: Arm C: BIM 23A760 4 mg|
264482|NCT00994214|E6|Reported Event|Part B: Arm B: BIM 23A760 2 mg|
264483|NCT00994214|E5|Reported Event|Overall - Part A|
264484|NCT00994214|E4|Reported Event|Part A: Arm D: BIM 23A760 6 mg|
264485|NCT00994214|E3|Reported Event|Part A: Arm C: BIM 23A760 4 mg|
264486|NCT00994214|E2|Reported Event|Part A: Arm B: BIM 23A760 2 mg|
264487|NCT00994214|E1|Reported Event|Part A: Arm A: BIM 23A760 1 mg|
264488|NCT00994123|B4|Baseline|Total|Total of all reporting groups
264489|NCT00994123|B3|Baseline|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
264490|NCT00994123|B2|Baseline|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264491|NCT00994123|B1|Baseline|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 + Erlotinib in patients with NSCLC
264492|NCT00994123|P3|Participant Flow|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
264493|NCT00994123|P2|Participant Flow|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264494|NCT00994123|P1|Participant Flow|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 and erlotinib
264495|NCT00994123|O4|Outcome|HRG Low: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264496|NCT00994123|O3|Outcome|HRG Low: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
265475|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
264497|NCT00994123|O2|Outcome|HRG High: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
264498|NCT00994123|O1|Outcome|HRG High: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264499|NCT00994123|O2|Outcome|Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
264500|NCT00994123|O1|Outcome|MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264501|NCT00994123|O1|Outcome|Phase 1: All Participants|All participants in the dose escalation portion of the Phase 1
264502|NCT00994123|O7|Outcome|Cohort 7|MM-121 20 mg/kg (Q3W IV) + erlotinib 100 mg (PO daily)
264503|NCT00994123|O6|Outcome|Cohort 6|MM-121 20 mg/kg (Q2W IV) + erlotinib 100 mg (PO daily)
264504|NCT00994123|O5|Outcome|Cohort 5|MM-121 20 mg/kg (weekly IV) + erlotinib 100 mg (PO daily)
264505|NCT00994123|O4|Outcome|Cohort 4|MM-121 12 mg/kg (Q2W IV) + 150 mg erlotinib (PO daily)
264506|NCT00994123|O3|Outcome|Cohort 3|MM-121 12 mg/kg (Q2W IV) + 100 mg erlotinib (daily PO)
264507|NCT00994123|O2|Outcome|Cohort 2|6 mg/kg MM-121 Q2W + 150 mg erlotinib (daily PO)
264508|NCT00994123|O1|Outcome|Cohort 1|MM-121 6 mk/kg (Q2W IV) and 100 mg erlotinib (daily PO)
264509|NCT00994123|E3|Reported Event|Ph 1: MM-121 + Erlotinib|Escalating Doses of MM-121 + erlotinib
264510|NCT00994123|E2|Reported Event|Ph 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
264511|NCT00994123|E1|Reported Event|Ph 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
264512|NCT00994110|B3|Baseline|Total|Total of all reporting groups
264513|NCT00994110|B2|Baseline|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
264514|NCT00994110|B1|Baseline|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
264515|NCT00994110|P2|Participant Flow|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
264516|NCT00994110|P1|Participant Flow|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
264517|NCT00994110|O2|Outcome|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
264536|NCT00993915|P1|Participant Flow|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
276862|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
264518|NCT00994110|O1|Outcome|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
264519|NCT00994110|E2|Reported Event|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
264520|NCT00994110|E1|Reported Event|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
264521|NCT00993954|B3|Baseline|Total|Total of all reporting groups
264522|NCT00993954|B2|Baseline|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264523|NCT00993954|B1|Baseline|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264524|NCT00993954|P2|Participant Flow|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264525|NCT00993954|P1|Participant Flow|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264526|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264527|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264528|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264529|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264530|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264531|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264532|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264533|NCT00993954|E2|Reported Event|Physician Reduction|"Patients randomized to reduction by physician~Physicians were free to use the reduction method of their choice"
264534|NCT00993954|E1|Reported Event|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
264535|NCT00993915|B1|Baseline|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264537|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264538|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264539|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264540|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264541|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264542|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264543|NCT00993915|E1|Reported Event|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
264544|NCT00993824|B3|Baseline|Total|Total of all reporting groups
264545|NCT00993824|B2|Baseline|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
264546|NCT00993824|B1|Baseline|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
264547|NCT00993824|P2|Participant Flow|Placebo Then Welchol|Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
264548|NCT00993824|P1|Participant Flow|Welchol Then Placebo|3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
264549|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264550|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264551|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264552|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264553|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264554|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
264555|NCT00993824|O2|Outcome|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
264556|NCT00993824|O1|Outcome|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
264557|NCT00993824|E2|Reported Event|Placebo|Placebo taken at evening meal
264558|NCT00993824|E1|Reported Event|Welchol|3.75 grams of colesevelam HCl taken at evening meal
264559|NCT00993668|B3|Baseline|Total|Total of all reporting groups
264560|NCT00993668|B2|Baseline|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264561|NCT00993668|B1|Baseline|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264562|NCT00993668|P2|Participant Flow|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264563|NCT00993668|P1|Participant Flow|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264564|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264565|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
265115|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
264566|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264567|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264568|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264569|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264570|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264571|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264572|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264573|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264574|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264575|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264576|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264577|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264578|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264579|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264580|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264581|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264582|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
264583|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264584|NCT00993668|E3|Reported Event|Cimzia at Any Time|Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
264585|NCT00993668|E2|Reported Event|Cimzia (Single Blind)|Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4
264586|NCT00993668|E1|Reported Event|Placebo (Single Blind)|Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4
264587|NCT00993616|B1|Baseline|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
264588|NCT00993616|P1|Participant Flow|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
264620|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264589|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
264590|NCT00993616|E1|Reported Event|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
264591|NCT00993499|B7|Baseline|Total|Total of all reporting groups
264592|NCT00993499|B6|Baseline|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264593|NCT00993499|B5|Baseline|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264594|NCT00993499|B4|Baseline|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264595|NCT00993499|B3|Baseline|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264596|NCT00993499|B2|Baseline|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264597|NCT00993499|B1|Baseline|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264598|NCT00993499|P6|Participant Flow|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264599|NCT00993499|P5|Participant Flow|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264600|NCT00993499|P4|Participant Flow|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264601|NCT00993499|P3|Participant Flow|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264602|NCT00993499|P2|Participant Flow|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264603|NCT00993499|P1|Participant Flow|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264604|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264605|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264606|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264607|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264608|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264609|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264610|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264611|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264612|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264613|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264614|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264615|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264616|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264617|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264618|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264619|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
265054|NCT00992836|O1|Outcome|All Study Participants|All 155 study participants are included in this analysis.
264621|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264622|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264623|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264624|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264625|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264626|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264627|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264628|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264629|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264630|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264631|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264632|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264633|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264634|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264635|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264636|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264637|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264638|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264639|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264640|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264641|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264642|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264643|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264644|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264645|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264646|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264647|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264648|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264649|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264650|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264651|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264652|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264653|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
276863|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
264654|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264655|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264656|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264657|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264658|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264659|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264660|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264661|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264662|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264663|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264664|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264665|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264666|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264667|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264668|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264669|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264670|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264671|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264672|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264673|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264674|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264675|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264676|NCT00993499|E6|Reported Event|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
264677|NCT00993499|E5|Reported Event|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
264678|NCT00993499|E4|Reported Event|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
264679|NCT00993499|E3|Reported Event|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
264680|NCT00993499|E2|Reported Event|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
264681|NCT00993499|E1|Reported Event|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
264682|NCT00993473|B3|Baseline|Total|Total of all reporting groups
264683|NCT00993473|B2|Baseline|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264684|NCT00993473|B1|Baseline|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264685|NCT00993473|P2|Participant Flow|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264686|NCT00993473|P1|Participant Flow|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264687|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264688|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264689|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264690|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264691|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264692|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264693|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264694|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264695|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264696|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264697|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264698|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264699|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264700|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264701|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264702|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264703|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264704|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264705|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264706|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264707|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264708|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264709|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264710|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264711|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264712|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264713|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264714|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264715|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264716|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264717|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264718|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
264719|NCT00993473|E2|Reported Event|NPH Insulin|
264720|NCT00993473|E1|Reported Event|Lantus|
264721|NCT00993447|B3|Baseline|Total|Total of all reporting groups
264722|NCT00993447|B2|Baseline|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264723|NCT00993447|B1|Baseline|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264724|NCT00993447|P2|Participant Flow|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264725|NCT00993447|P1|Participant Flow|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264726|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264727|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264728|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264729|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264730|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264731|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264732|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264733|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264734|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264735|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264736|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264737|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264738|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264739|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264740|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264741|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264742|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264743|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264744|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264745|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264746|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264747|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264748|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264749|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264750|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264751|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264752|NCT00993447|E2|Reported Event|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
264753|NCT00993447|E1|Reported Event|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
264754|NCT00993421|B8|Baseline|Total|Total of all reporting groups
264755|NCT00993421|B7|Baseline|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264756|NCT00993421|B6|Baseline|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264757|NCT00993421|B5|Baseline|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264758|NCT00993421|B4|Baseline|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264759|NCT00993421|B3|Baseline|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264760|NCT00993421|B2|Baseline|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264761|NCT00993421|B1|Baseline|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264762|NCT00993421|P7|Participant Flow|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264763|NCT00993421|P6|Participant Flow|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264764|NCT00993421|P5|Participant Flow|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264765|NCT00993421|P4|Participant Flow|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264766|NCT00993421|P3|Participant Flow|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264767|NCT00993421|P2|Participant Flow|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264768|NCT00993421|P1|Participant Flow|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264769|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264770|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264771|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264772|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264773|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264774|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264775|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264776|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264777|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264778|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264779|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264780|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264781|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264782|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264783|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264784|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264785|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264786|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264787|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264788|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264789|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264790|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264791|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264792|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264793|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264794|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264795|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264796|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264797|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264798|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264799|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264800|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264801|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264802|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264803|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264804|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264805|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264806|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264807|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264808|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264809|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264810|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
265209|NCT00992589|E4|Reported Event|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
264811|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264812|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264813|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264814|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264815|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264816|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264817|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264818|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264819|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264820|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264821|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264822|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264823|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264824|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264825|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264826|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264827|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264828|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264829|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264830|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264831|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264832|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264833|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264834|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264835|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264836|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264837|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264838|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264839|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
265476|NCT00992108|E2|Reported Event|Botulinum|chemodenervation: botulinum toxin
264840|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264841|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264842|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264843|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264844|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264845|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264846|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264847|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264848|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264849|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264850|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264851|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264852|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264853|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264854|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264855|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264856|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264857|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264858|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264859|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264860|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264861|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264862|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264863|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264864|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264865|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264866|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264867|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264868|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
265477|NCT00992108|E1|Reported Event|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
264869|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264870|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264871|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264872|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264873|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264874|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264875|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264876|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264877|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264878|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264879|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264880|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264881|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264882|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264883|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264884|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264885|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264886|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264887|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264888|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264889|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264890|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264891|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264892|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264893|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264894|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264895|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264896|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264897|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
265478|NCT00992056|B3|Baseline|Total|Total of all reporting groups
264898|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264899|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264900|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264901|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264902|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264903|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264904|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264905|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
264906|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
264907|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264908|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264909|NCT00993421|E7|Reported Event|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264910|NCT00993421|E6|Reported Event|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264911|NCT00993421|E5|Reported Event|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264912|NCT00993421|E4|Reported Event|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
264913|NCT00993421|E3|Reported Event|Sibutramine (30mg)/Metoprolol (200mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).~Placebo LY377604: given orally, daily for 24 weeks."
264914|NCT00993421|E2|Reported Event|LY377604 (75 mg)|Given orally, daily for 24 weeks.
264915|NCT00993421|E1|Reported Event|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
264916|NCT00993317|B3|Baseline|Total|Total of all reporting groups
264917|NCT00993317|B2|Baseline|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264918|NCT00993317|B1|Baseline|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264919|NCT00993317|P2|Participant Flow|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264920|NCT00993317|P1|Participant Flow|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264921|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264922|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264923|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264924|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264925|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264926|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264927|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264928|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264929|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264930|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264931|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264932|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264933|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264934|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264935|NCT00993317|E2|Reported Event|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
264936|NCT00993317|E1|Reported Event|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
264937|NCT00993291|B1|Baseline|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
264938|NCT00993291|P1|Participant Flow|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
264939|NCT00993291|O1|Outcome|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
264940|NCT00993291|E1|Reported Event|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
264941|NCT00993265|B3|Baseline|Total|Total of all reporting groups
264942|NCT00993265|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264943|NCT00993265|B1|Baseline|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264944|NCT00993265|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264945|NCT00993265|P1|Participant Flow|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264946|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264947|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264948|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264949|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264950|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264951|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264952|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264953|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264954|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264955|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264956|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264957|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264958|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264959|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264960|NCT00993265|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
264961|NCT00993265|E1|Reported Event|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
264962|NCT00993200|B3|Baseline|Total|Total of all reporting groups
264963|NCT00993200|B2|Baseline|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
264964|NCT00993200|B1|Baseline|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
264965|NCT00993200|P2|Participant Flow|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
264966|NCT00993200|P1|Participant Flow|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
264967|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
264968|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
264969|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
264970|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
264971|NCT00993200|O2|Outcome|PERMIT|Warfarin management with use of gene-based warfarin dosing algorithm
264972|NCT00993200|O1|Outcome|Standard|Standard of care warfarin management
264973|NCT00993200|E2|Reported Event|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
264974|NCT00993200|E1|Reported Event|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
264975|NCT00993187|B3|Baseline|Total|Total of all reporting groups
264976|NCT00993187|B2|Baseline|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264977|NCT00993187|B1|Baseline|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264978|NCT00993187|P2|Participant Flow|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264979|NCT00993187|P1|Participant Flow|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264980|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264981|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264982|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264983|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264984|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264985|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
265210|NCT00992589|E3|Reported Event|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
264986|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264987|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264988|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264989|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264990|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264991|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264992|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264993|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264994|NCT00993187|E2|Reported Event|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
264995|NCT00993187|E1|Reported Event|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
264996|NCT00993148|B1|Baseline|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
264997|NCT00993148|P1|Participant Flow|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
264998|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
264999|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265000|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265001|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265002|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265003|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265004|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265005|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265006|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265007|NCT00993148|E1|Reported Event|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
265008|NCT00993044|B1|Baseline|Dose Level 1, 2|
265009|NCT00993044|P1|Participant Flow|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
265010|NCT00993044|O1|Outcome|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
265011|NCT00993044|E2|Reported Event|Dose Level 2|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5"
265012|NCT00993044|E1|Reported Event|Dose Level 1|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5"
265013|NCT00992992|B1|Baseline|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265014|NCT00992992|P1|Participant Flow|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265015|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265016|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265017|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265018|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265019|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265020|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265055|NCT00992836|E1|Reported Event|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265056|NCT00992784|B4|Baseline|Total|Total of all reporting groups
265057|NCT00992784|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265058|NCT00992784|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265059|NCT00992784|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265021|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265022|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265023|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265024|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265025|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265026|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265027|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265028|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265060|NCT00992784|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265061|NCT00992784|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265062|NCT00992784|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265063|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265064|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
276864|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
265029|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265030|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265031|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265032|NCT00992992|E1|Reported Event|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
265033|NCT00992927|B3|Baseline|Total|Total of all reporting groups
265034|NCT00992927|B2|Baseline|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
265035|NCT00992927|B1|Baseline|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
265036|NCT00992927|P2|Participant Flow|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
265037|NCT00992927|P1|Participant Flow|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
265038|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
265039|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
265040|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
265041|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
265042|NCT00992927|E2|Reported Event|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
265043|NCT00992927|E1|Reported Event|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
265044|NCT00992836|B1|Baseline|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265045|NCT00992836|P1|Participant Flow|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265046|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
265047|NCT00992836|O1|Outcome|Influenza A (H1N1) 2009 Monovalent Vaccine|"All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.~Influenza A (H1N1) 2009 monovalent vaccine: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections"
265048|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
265049|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140, 142 and 138, for the analysis of antibody titers after the first and second vaccinations and after 6 months after the second vaccination, respectively.
265050|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 138, those who received both vaccinations and had nonmissing data.
265051|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.
265052|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
265053|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
265065|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265066|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265067|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265068|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265069|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265070|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265071|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265072|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265073|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265074|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265075|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265076|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265077|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265078|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265079|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265080|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265081|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265082|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265083|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265084|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265085|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265086|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265087|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265088|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265089|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265090|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265091|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265092|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265093|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265094|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265095|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265096|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265097|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265098|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265099|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265100|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265101|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265102|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265103|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265104|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265105|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265106|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265107|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265108|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265109|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265110|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265111|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265112|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265113|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265114|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265116|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265117|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265118|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265119|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265120|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265121|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265122|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265123|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265124|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265125|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265126|NCT00992784|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
265127|NCT00992784|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
265128|NCT00992784|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
265129|NCT00992719|B4|Baseline|Total|Total of all reporting groups
265130|NCT00992719|B3|Baseline|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265131|NCT00992719|B2|Baseline|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265132|NCT00992719|B1|Baseline|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265133|NCT00992719|P3|Participant Flow|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265134|NCT00992719|P2|Participant Flow|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265135|NCT00992719|P1|Participant Flow|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265136|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265137|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265138|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265139|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265140|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265141|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265142|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265143|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265144|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265145|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265146|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265147|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265148|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265149|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265150|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265151|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265152|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265153|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265154|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265155|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265156|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265157|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
276865|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
265158|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265159|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265160|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265161|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265162|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265163|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265164|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265165|NCT00992719|E3|Reported Event|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265166|NCT00992719|E2|Reported Event|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265167|NCT00992719|E1|Reported Event|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
265168|NCT00992589|B1|Baseline|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265169|NCT00992589|P4|Participant Flow|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265170|NCT00992589|P3|Participant Flow|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265171|NCT00992589|P2|Participant Flow|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265172|NCT00992589|P1|Participant Flow|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265173|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265174|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265175|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265176|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265177|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265178|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265179|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265180|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265181|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265182|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265183|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265184|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265185|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265186|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265187|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265188|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265189|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265190|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265191|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265192|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265193|NCT00992589|O8|Outcome|Double-Blind Rabeprazole Sodium Total - Week 8|Rabeprazole Sodium capsules once daily in the morning.
265194|NCT00992589|O7|Outcome|Double-Blind Rabeprazole Sodium Total - Baseline|Rabeprazole Sodium capsules once daily in the morning.
265195|NCT00992589|O6|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
265196|NCT00992589|O5|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
265197|NCT00992589|O4|Outcome|Double-Blind Placebo - Week 8|Matching placebo capsules once daily in the morning.
265198|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
265199|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
265200|NCT00992589|O1|Outcome|Double-Blind Placebo - Baseline|Matching placebo capsules once daily in the morning.
265201|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265202|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265203|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265204|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265205|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
265206|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265207|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
265208|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265211|NCT00992589|E2|Reported Event|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
265212|NCT00992589|E1|Reported Event|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
265213|NCT00992459|B3|Baseline|Total|Total of all reporting groups
265214|NCT00992459|B2|Baseline|Treatment Arm B|Patients randomized to receive HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 1) followed by NaPBA + HPN-100 placebo for 2 weeks (Treatment Period 2)
265215|NCT00992459|B1|Baseline|Treatment Arm A|Patients randomized to receive NaPBA + HPN 100 placebo for 2 weeks (Treatment Period 1) followed by HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 2)
265216|NCT00992459|P2|Participant Flow|Arm B|Subjects in Arm B were assigned to receive HPN-100 + NaPBA placebo for 2 weeks All patients in Arm B received NaPBA placebo (+ concomitant active HPN 100)
265217|NCT00992459|P1|Participant Flow|Arm A|Subjects in Arm A were assigned to receive NaPBA + HPN 100 placebo for 2 weeks All patients in Arm A received HPN100 placebo (+ concomitant active NaPBA)
265218|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265219|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265220|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265221|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265222|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265223|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265224|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265225|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265226|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265227|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265228|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265229|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265230|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265231|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265232|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265233|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265234|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265235|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265236|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
265237|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
265238|NCT00992459|E2|Reported Event|HPN-100|Patients received HPN-100
265239|NCT00992459|E1|Reported Event|NaPBA|Patients received NaPBA
265240|NCT00992433|B3|Baseline|Total|Total of all reporting groups
265241|NCT00992433|B2|Baseline|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265242|NCT00992433|B1|Baseline|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265243|NCT00992433|P2|Participant Flow|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265244|NCT00992433|P1|Participant Flow|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265245|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265246|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265247|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265248|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265249|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265250|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265251|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265252|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265253|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265254|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265255|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265256|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265257|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265258|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265259|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265260|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265261|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265262|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265263|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265264|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265265|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265266|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265467|NCT00992108|P1|Participant Flow|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
265267|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265268|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265269|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265270|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265271|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265272|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265273|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265274|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265275|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265276|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265277|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265278|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265279|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265280|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265281|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265282|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265283|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265284|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265285|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265286|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265287|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265288|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265289|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265290|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265291|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265292|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265293|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265294|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265295|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265296|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265297|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265298|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265299|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265300|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265301|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265302|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265303|NCT00992433|E2|Reported Event|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265304|NCT00992433|E1|Reported Event|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
265305|NCT00992407|B3|Baseline|Total|Total of all reporting groups
265306|NCT00992407|B2|Baseline|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265307|NCT00992407|B1|Baseline|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265308|NCT00992407|P2|Participant Flow|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265309|NCT00992407|P1|Participant Flow|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265310|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265311|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265312|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265313|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265314|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265315|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265316|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265317|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265318|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265319|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265320|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265321|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265322|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265323|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265324|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265325|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265326|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablets were administered orally as 0.5–10 mg daily up to Week 52.
265327|NCT00992407|O1|Outcome|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265328|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265329|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265330|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265331|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265332|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265333|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265334|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265335|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265336|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265337|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265338|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265339|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265340|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265341|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265342|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265343|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265344|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265345|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265346|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265347|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265348|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablet were administered orally as 0.5–10 mg daily up to Week 52.
265349|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265350|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265468|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
265351|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265352|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265353|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265354|NCT00992407|E2|Reported Event|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
265355|NCT00992407|E1|Reported Event|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
265356|NCT00992394|B3|Baseline|Total|Total of all reporting groups
265357|NCT00992394|B2|Baseline|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265358|NCT00992394|B1|Baseline|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265359|NCT00992394|P2|Participant Flow|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265360|NCT00992394|P1|Participant Flow|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265361|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265362|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265363|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265364|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265365|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265366|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265367|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265368|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265369|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265370|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265371|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265372|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265373|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265374|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265375|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265376|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265377|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265378|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265469|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
265379|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265380|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265381|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265382|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265383|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265384|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265385|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265386|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265387|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265388|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265389|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265390|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265391|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265392|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265393|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265394|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265395|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265396|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265397|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265398|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265399|NCT00992394|E2|Reported Event|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
265400|NCT00992394|E1|Reported Event|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
265401|NCT00992264|B17|Baseline|Total|Total of all reporting groups
265402|NCT00992264|B16|Baseline|Randomization Arm: 16|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
265403|NCT00992264|B15|Baseline|Randomization Arm: 15|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
265404|NCT00992264|B14|Baseline|Randomization Arm: 14|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
265405|NCT00992264|B13|Baseline|Randomization Arm: 13|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
265470|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
265471|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
265406|NCT00992264|B12|Baseline|Randomization Arm: 12|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
265407|NCT00992264|B11|Baseline|Randomization Arm: 11|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
265408|NCT00992264|B10|Baseline|Randomization Arm: 10|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
265409|NCT00992264|B9|Baseline|Randomization Arm: 9|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
265410|NCT00992264|B8|Baseline|Randomization Arm: 8|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
265411|NCT00992264|B7|Baseline|Randomization Arm: 7|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
265412|NCT00992264|B6|Baseline|Randomization Arm: 6|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
265413|NCT00992264|B5|Baseline|Randomization Arm: 5|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
265414|NCT00992264|B4|Baseline|Randomization Arm: 4|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
265415|NCT00992264|B3|Baseline|Randomization Arm: 3|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
265416|NCT00992264|B2|Baseline|Radndomization Arm: 2|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
265417|NCT00992264|B1|Baseline|Randomization Arm: 1|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
265418|NCT00992264|P16|Participant Flow|Randomization Arm 16|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]
265419|NCT00992264|P15|Participant Flow|Randomization Arm 15|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
265420|NCT00992264|P14|Participant Flow|Randomization Arm 14|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
265421|NCT00992264|P13|Participant Flow|Randomization Arm 13|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
265422|NCT00992264|P12|Participant Flow|Randomization Arm 12|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
265423|NCT00992264|P11|Participant Flow|Randomization Arm 11|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
265424|NCT00992264|P10|Participant Flow|Randomization Arm 10|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
265425|NCT00992264|P9|Participant Flow|Randomization Arm 9|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
265426|NCT00992264|P8|Participant Flow|Randomization Arm 8|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
265427|NCT00992264|P7|Participant Flow|Randomization Arm 7|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
265428|NCT00992264|P6|Participant Flow|Randomization Arm 6|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
265429|NCT00992264|P5|Participant Flow|Randomization Arm 5|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
265430|NCT00992264|P4|Participant Flow|Randomization Arm 4|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
265431|NCT00992264|P3|Participant Flow|Randomization Arm 3|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
265432|NCT00992264|P2|Participant Flow|Randomization Arm 2|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
265433|NCT00992264|P1|Participant Flow|Randomization Arm 1|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
265434|NCT00992264|O4|Outcome|Proactive Emails|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
265435|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
265436|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
265437|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
265438|NCT00992264|O4|Outcome|Proactive Outreach|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
265439|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
265440|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
265441|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
265442|NCT00992264|E4|Reported Event|Proactive Outreach|"Email or No-Email communication~Persons are randomized to receive periodic email reminders to return to the intervention website or not."
265443|NCT00992264|E3|Reported Event|Navigation|"Dictated or Non-Dictated~Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking."
265444|NCT00992264|E2|Reported Event|Testimonials|"Testimonial or No Testimonial~Persons are randomized to receive a personally tailored testimonial or not."
265445|NCT00992264|E1|Reported Event|Message Tone|"Prescriptive or Motivational~Persons are randomized to receive intervention content written in either a prescriptive or motivational tone."
265446|NCT00992186|B1|Baseline|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265447|NCT00992186|P1|Participant Flow|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265448|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265449|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265450|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265451|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265452|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265453|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265454|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265455|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265456|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265457|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265458|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265459|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265460|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265461|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265462|NCT00992186|E1|Reported Event|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
265463|NCT00992108|B3|Baseline|Total|Total of all reporting groups
265464|NCT00992108|B2|Baseline|Botulinum|chemodenervation: botulinum toxin
265465|NCT00992108|B1|Baseline|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
265466|NCT00992108|P2|Participant Flow|Botulinum|chemodenervation: botulinum toxin
265472|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
265479|NCT00992056|B2|Baseline|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg
265480|NCT00992056|B1|Baseline|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg
265481|NCT00992056|P2|Participant Flow|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
265482|NCT00992056|P1|Participant Flow|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.
265483|NCT00992056|O2|Outcome|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
265484|NCT00992056|O1|Outcome|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
265485|NCT00992056|E2|Reported Event|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
265486|NCT00992056|E1|Reported Event|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
265487|NCT00992017|B1|Baseline|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265488|NCT00992017|P1|Participant Flow|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265489|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
265490|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
265491|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
265492|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
265493|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
265494|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received H1N1 vaccinations.
265495|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
265496|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
265497|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
265498|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women enrolled in the study.
265499|NCT00992017|E1|Reported Event|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
265500|NCT00991952|B3|Baseline|Total|Total of all reporting groups
265501|NCT00991952|B2|Baseline|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
265502|NCT00991952|B1|Baseline|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
265503|NCT00991952|P2|Participant Flow|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
265504|NCT00991952|P1|Participant Flow|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
265505|NCT00991952|O2|Outcome|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
265506|NCT00991952|O1|Outcome|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
265507|NCT00991952|E2|Reported Event|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
265508|NCT00991952|E1|Reported Event|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
265509|NCT00991939|B3|Baseline|Total|Total of all reporting groups
265510|NCT00991939|B2|Baseline|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265511|NCT00991939|B1|Baseline|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265570|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265871|NCT00990769|B2|Baseline|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265512|NCT00991939|P2|Participant Flow|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265513|NCT00991939|P1|Participant Flow|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265514|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265515|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265516|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265517|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265518|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265519|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265520|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265521|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265522|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265523|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265524|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265525|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265526|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265527|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265528|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265529|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265530|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265531|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265532|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265533|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265534|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265535|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265536|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265537|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265538|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265539|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265540|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265541|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265571|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265542|NCT00991939|E2|Reported Event|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
265543|NCT00991939|E1|Reported Event|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
265544|NCT00991809|B3|Baseline|Total|Total of all reporting groups
265545|NCT00991809|B2|Baseline|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
265546|NCT00991809|B1|Baseline|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
265547|NCT00991809|P2|Participant Flow|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
265548|NCT00991809|P1|Participant Flow|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
265549|NCT00991809|O2|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
265550|NCT00991809|O1|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
265551|NCT00991809|E2|Reported Event|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
265552|NCT00991809|E1|Reported Event|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
265553|NCT00991510|B3|Baseline|Total|Total of all reporting groups
265554|NCT00991510|B2|Baseline|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
265555|NCT00991510|B1|Baseline|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
265556|NCT00991510|P2|Participant Flow|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
265557|NCT00991510|P1|Participant Flow|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
265558|NCT00991510|O3|Outcome|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
265559|NCT00991510|O2|Outcome|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265560|NCT00991510|O1|Outcome|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265561|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265562|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265563|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265564|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265565|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265566|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265567|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265568|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265569|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265572|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265573|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265574|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265575|NCT00991510|E3|Reported Event|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
265576|NCT00991510|E2|Reported Event|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265577|NCT00991510|E1|Reported Event|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
265578|NCT00991458|B4|Baseline|Total|Total of all reporting groups
265579|NCT00991458|B3|Baseline|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265580|NCT00991458|B2|Baseline|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265581|NCT00991458|B1|Baseline|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265582|NCT00991458|P3|Participant Flow|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265583|NCT00991458|P2|Participant Flow|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265584|NCT00991458|P1|Participant Flow|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265585|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265586|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265587|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265588|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265589|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265590|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265591|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265592|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265593|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265594|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265595|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265596|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265597|NCT00991458|E3|Reported Event|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265598|NCT00991458|E2|Reported Event|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265599|NCT00991458|E1|Reported Event|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
265600|NCT00991341|B3|Baseline|Total|Total of all reporting groups
265601|NCT00991341|B2|Baseline|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265602|NCT00991341|B1|Baseline|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265603|NCT00991341|P2|Participant Flow|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265604|NCT00991341|P1|Participant Flow|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265605|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265606|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265607|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265608|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265609|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265610|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265611|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265612|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265613|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265614|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265615|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265616|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265617|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265618|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265619|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265620|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265621|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265622|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265623|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265724|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265725|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265624|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265625|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265626|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265627|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265628|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265629|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265630|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265631|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265632|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265633|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265634|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265635|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265636|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265637|NCT00991341|E2|Reported Event|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265638|NCT00991341|E1|Reported Event|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
265639|NCT00991302|B3|Baseline|Total|Total of all reporting groups
265640|NCT00991302|B2|Baseline|Standard Care|Participants received standard care.
265641|NCT00991302|B1|Baseline|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265642|NCT00991302|P2|Participant Flow|Standard Care|Participants received standard care.
265643|NCT00991302|P1|Participant Flow|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265644|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265645|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265646|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265647|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265648|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265726|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265727|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265649|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265650|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265651|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265652|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265653|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265654|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
265655|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265656|NCT00991302|E2|Reported Event|Standard Care|Participants received standard care.
265657|NCT00991302|E1|Reported Event|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
265658|NCT00991289|B1|Baseline|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265659|NCT00991289|P1|Participant Flow|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265660|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265661|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265662|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265663|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265664|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265665|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265666|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265667|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265668|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265669|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265670|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265671|NCT00991289|E1|Reported Event|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
265672|NCT00991276|B7|Baseline|Total|Total of all reporting groups
265728|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265729|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265673|NCT00991276|B6|Baseline|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265674|NCT00991276|B5|Baseline|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265675|NCT00991276|B4|Baseline|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265676|NCT00991276|B3|Baseline|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265677|NCT00991276|B2|Baseline|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265678|NCT00991276|B1|Baseline|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265679|NCT00991276|P6|Participant Flow|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265680|NCT00991276|P5|Participant Flow|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265681|NCT00991276|P4|Participant Flow|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265730|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265731|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265732|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265682|NCT00991276|P3|Participant Flow|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265683|NCT00991276|P2|Participant Flow|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265684|NCT00991276|P1|Participant Flow|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
265685|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265686|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265687|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265688|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265689|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265690|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265691|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265692|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265693|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265694|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265695|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265696|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265697|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265698|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265699|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265700|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily in any intervention period.
265701|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265702|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265703|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265704|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265705|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265706|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265707|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265708|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265709|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265710|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265711|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265712|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265713|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265714|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265715|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265716|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265717|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265718|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265719|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265720|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265721|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265722|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265723|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265733|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265734|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265735|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265736|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265737|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265738|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265739|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265740|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265741|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265742|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265743|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265744|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265745|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265746|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265747|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265748|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265749|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265750|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265751|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265752|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265753|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265754|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265755|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265756|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265757|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265758|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265759|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265760|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265761|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265762|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265763|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265764|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265765|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265766|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265767|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265768|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265769|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265770|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265771|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265772|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265773|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265774|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265775|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
265776|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265777|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265778|NCT00991276|E3|Reported Event|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period.
265779|NCT00991276|E2|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
265780|NCT00991276|E1|Reported Event|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
265781|NCT00991185|B1|Baseline|Vancomycin|children that received vancomycin per standard of care
265782|NCT00991185|P1|Participant Flow|Vancomycin|children that received vancomycin per standard of care
265783|NCT00991185|O1|Outcome|Vancomycin|children that received vancomycin per standard of care
265784|NCT00991185|E1|Reported Event|Vancomycin|children that received vancomycin per standard of care
265785|NCT00991081|B3|Baseline|Total|Total of all reporting groups
265786|NCT00991081|B2|Baseline|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
265787|NCT00991081|B1|Baseline|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
265869|NCT00990821|E1|Reported Event|90 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265788|NCT00991081|P3|Participant Flow|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
265789|NCT00991081|P2|Participant Flow|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
265790|NCT00991081|P1|Participant Flow|Formative Interviews|"Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.~Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10)."
265791|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265792|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265793|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265794|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265795|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265796|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265797|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265798|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265799|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265800|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265801|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265802|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265803|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265804|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265805|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265806|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265807|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265808|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265809|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265810|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265811|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265812|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265813|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265814|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265815|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265816|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265817|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265818|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265819|NCT00991081|E2|Reported Event|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265820|NCT00991081|E1|Reported Event|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
265821|NCT00990964|B1|Baseline|Attain Family Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
265822|NCT00990964|P1|Participant Flow|Attain Family Left Heart Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
265823|NCT00990964|O1|Outcome|Attain Family Lead Attempt, Any Catheter|Subjects who were attempted with Attain Family delivery catheters or Attain Family left-heart leads were included in this analysis.
265824|NCT00990964|O1|Outcome|Attain Family Lead and Catheter Attempt|Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
265825|NCT00990964|E1|Reported Event|Attain Family Lead|All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
265826|NCT00990821|B15|Baseline|Total|Total of all reporting groups
265827|NCT00990821|B14|Baseline|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
265828|NCT00990821|B13|Baseline|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
265829|NCT00990821|B12|Baseline|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
265830|NCT00990821|B11|Baseline|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
265831|NCT00990821|B10|Baseline|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
265832|NCT00990821|B9|Baseline|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
265833|NCT00990821|B8|Baseline|Part IV|40 mg MK-0517 (non-PS80 formulation)
265834|NCT00990821|B7|Baseline|Part III, Panel 2|40 mg MK-0517 (non-PS80)
265835|NCT00990821|B6|Baseline|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
265836|NCT00990821|B5|Baseline|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
265837|NCT00990821|B4|Baseline|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
265838|NCT00990821|B3|Baseline|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
265839|NCT00990821|B2|Baseline|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
265840|NCT00990821|B1|Baseline|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
265841|NCT00990821|P14|Participant Flow|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
265842|NCT00990821|P13|Participant Flow|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
265843|NCT00990821|P12|Participant Flow|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
265844|NCT00990821|P11|Participant Flow|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
265845|NCT00990821|P10|Participant Flow|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
265846|NCT00990821|P9|Participant Flow|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
265847|NCT00990821|P8|Participant Flow|Part IV|40 mg MK-0517 (non-PS80 formulation)
265848|NCT00990821|P7|Participant Flow|Part III, Panel 2|40 mg MK-0517 (non-PS80)
265849|NCT00990821|P6|Participant Flow|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
265850|NCT00990821|P5|Participant Flow|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
265851|NCT00990821|P4|Participant Flow|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
265852|NCT00990821|P3|Participant Flow|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
265853|NCT00990821|P2|Participant Flow|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
265854|NCT00990821|P1|Participant Flow|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
265855|NCT00990821|O3|Outcome|MK-0517 (115 mg)|115 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
265856|NCT00990821|O2|Outcome|MK-0517 (100 mg)|100 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
265857|NCT00990821|O1|Outcome|Aprepitant (125 mg)|A single oral dose with an Aprepitant capsule
265858|NCT00990821|E12|Reported Event|2 mg Midazolam|Midazolam administered as a single oral solution
265859|NCT00990821|E11|Reported Event|125 mg Aprepitant|Aprepitant administered as a single oral capsule
265860|NCT00990821|E10|Reported Event|40 mg Aprepitant|Aprepitant administered by a single oral capsule
265861|NCT00990821|E9|Reported Event|Placebo|Placebo matching MK-0517 (PS80 or non-PS80)
265862|NCT00990821|E8|Reported Event|150 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265863|NCT00990821|E7|Reported Event|100 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265864|NCT00990821|E6|Reported Event|40 mg MK-0517 (Non-PS80)|MK-0517, non-PS80 formulation, administered with a single IV administration
265865|NCT00990821|E5|Reported Event|150 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265866|NCT00990821|E4|Reported Event|115 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265867|NCT00990821|E3|Reported Event|100 mg MK-0517 (PS80) + 2 mg Midazolam|PS80 formulation, administered with a single IV administration and a single oral administration of midazolam
265868|NCT00990821|E2|Reported Event|100 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
265872|NCT00990769|B1|Baseline|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265873|NCT00990769|P2|Participant Flow|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265874|NCT00990769|P1|Participant Flow|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265875|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265876|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265877|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265878|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265879|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265880|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265881|NCT00990769|E2|Reported Event|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
265882|NCT00990769|E1|Reported Event|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
265883|NCT00990704|B3|Baseline|Total|Total of all reporting groups
265884|NCT00990704|B2|Baseline|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265885|NCT00990704|B1|Baseline|Paricalcitol|2 mcg with incremental of 1 mcg
265886|NCT00990704|P2|Participant Flow|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265887|NCT00990704|P1|Participant Flow|Paricalcitol|2 mcg with incremental of 1 mcg
265888|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265889|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265890|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265891|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265892|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265893|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265894|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265895|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265896|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265897|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265898|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265899|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265900|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265901|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265902|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265903|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
265904|NCT00990704|E2|Reported Event|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
265905|NCT00990704|E1|Reported Event|Paricalcitol|2 mcg with incremental of 1 mcg
265906|NCT00990652|B1|Baseline|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
265907|NCT00990652|P1|Participant Flow|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
265908|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
265909|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
265910|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
266008|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265911|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
265912|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
265913|NCT00990652|E1|Reported Event|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
265914|NCT00990561|B3|Baseline|Total|Total of all reporting groups
265915|NCT00990561|B2|Baseline|Ultravate Once a Day|Ultravate ointment applied once daily
265916|NCT00990561|B1|Baseline|Ultravate Twice a Day|
265917|NCT00990561|P4|Participant Flow|No Treatment|
265918|NCT00990561|P3|Participant Flow|Lac-Hydrin Topically Twice a Day|
265919|NCT00990561|P2|Participant Flow|Once Daily Topical Ultravate Ointment + LacHydrin Lotion|
265920|NCT00990561|P1|Participant Flow|Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily|
265921|NCT00990561|O2|Outcome|Ultravate 0.05% Ointment Once Daily|Ultravate one daily to affected area.
265922|NCT00990561|O1|Outcome|Ultravate 0.05% Ointment Twice Daily|Ultravate twice daily to affected area.
265923|NCT00990561|E2|Reported Event|Ultravate Once a Day|Ultravate ointment applied once daily
265924|NCT00990561|E1|Reported Event|Ultravate Twice a Day|
265925|NCT00990509|B3|Baseline|Total|Total of all reporting groups
265926|NCT00990509|B2|Baseline|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265927|NCT00990509|B1|Baseline|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265928|NCT00990509|P2|Participant Flow|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265929|NCT00990509|P1|Participant Flow|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265930|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265931|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265932|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265933|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
266009|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266010|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
269097|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
265934|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265935|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265936|NCT00990509|E2|Reported Event|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265937|NCT00990509|E1|Reported Event|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
265938|NCT00990340|B3|Baseline|Total|Total of all reporting groups
265939|NCT00990340|B2|Baseline|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
265940|NCT00990340|B1|Baseline|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
265941|NCT00990340|P2|Participant Flow|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
265942|NCT00990340|P1|Participant Flow|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
265943|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
265944|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
265945|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
265946|NCT00990340|O1|Outcome|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
265947|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
265948|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
265949|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
265950|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
265951|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
265952|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
265953|NCT00990340|E2|Reported Event|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
265954|NCT00990340|E1|Reported Event|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
265955|NCT00990184|B1|Baseline|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
265956|NCT00990184|P1|Participant Flow|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
265957|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline (end of two week placebo run in period)
265958|NCT00990184|O1|Outcome|Colesevelam 3.75 g Daily|Medication used to treat people with increased cholesterol levels
265959|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline
265960|NCT00990184|E1|Reported Event|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
265961|NCT00990106|B3|Baseline|Total|Total of all reporting groups
265962|NCT00990106|B2|Baseline|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
265963|NCT00990106|B1|Baseline|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265964|NCT00990106|P2|Participant Flow|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
265965|NCT00990106|P1|Participant Flow|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265966|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
266011|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266012|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
265967|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265968|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
265969|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265970|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
265971|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265972|NCT00990106|E2|Reported Event|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
265973|NCT00990106|E1|Reported Event|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
265974|NCT00990093|B1|Baseline|Entire Study Population|
265975|NCT00990093|P2|Participant Flow|B: First Standard Catheter Then Test Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
265976|NCT00990093|P1|Participant Flow|A: First Test Catheter Then Standard Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
265977|NCT00990093|O2|Outcome|Standard Catheter|SpeediCath Catheter
265978|NCT00990093|O1|Outcome|Test Catheter|SpeediCath Compact Male Catheter
265979|NCT00990093|E2|Reported Event|Standard Catheter|SpeediCath, CH 12 hydrophilic coated intermittent catheter
265980|NCT00990093|E1|Reported Event|Test Catheter|SpeediCath Compact Male
265981|NCT00989989|B4|Baseline|Total|Total of all reporting groups
265982|NCT00989989|B3|Baseline|Laser Control|Active laser treatment plus sham intravitreal injections.
265983|NCT00989989|B2|Baseline|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265984|NCT00989989|B1|Baseline|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265985|NCT00989989|P3|Participant Flow|Laser Control|Active laser treatment plus sham intravitreal injections.
265986|NCT00989989|P2|Participant Flow|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265987|NCT00989989|P1|Participant Flow|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265988|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
265989|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265990|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265991|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
265992|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265993|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265994|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
265995|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265996|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
265997|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
265998|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
265999|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266000|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266001|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266002|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266003|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266004|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266005|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266006|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266007|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
270378|NCT00978029|B1|Baseline|Placebo|Matching placebo tablet sublingual, once daily
266013|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266014|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266015|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266016|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266017|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266018|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
266019|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266020|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266021|NCT00989989|E3|Reported Event|Laser Control|Active laser treatment plus sham intravitreal injections.
266022|NCT00989989|E2|Reported Event|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
266023|NCT00989989|E1|Reported Event|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
266024|NCT00989950|B5|Baseline|Total|Total of all reporting groups
266025|NCT00989950|B4|Baseline|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266026|NCT00989950|B3|Baseline|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266027|NCT00989950|B2|Baseline|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266028|NCT00989950|B1|Baseline|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266029|NCT00989950|P4|Participant Flow|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266030|NCT00989950|P3|Participant Flow|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266031|NCT00989950|P2|Participant Flow|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266032|NCT00989950|P1|Participant Flow|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266033|NCT00989950|O4|Outcome|12 hr Wear|Result for all patients when patch worn for 12 hrs/day
266034|NCT00989950|O3|Outcome|11 hr Wear|Result for all patients when patch worn for 11 hrs/day
266035|NCT00989950|O2|Outcome|10 hr Wear|Result for all patients when patch worn for 10 hrs/day
266036|NCT00989950|O1|Outcome|9 hr Wear|Result for all patients when patch worn for 9 hrs/day
266037|NCT00989950|E4|Reported Event|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266038|NCT00989950|E3|Reported Event|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266039|NCT00989950|E2|Reported Event|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266040|NCT00989950|E1|Reported Event|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
266041|NCT00989911|B1|Baseline|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
266042|NCT00989911|P1|Participant Flow|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
266043|NCT00989911|O1|Outcome|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
266044|NCT00989911|E1|Reported Event|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
266045|NCT00989833|B4|Baseline|Total|Total of all reporting groups
266046|NCT00989833|B3|Baseline|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266047|NCT00989833|B2|Baseline|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266048|NCT00989833|B1|Baseline|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266049|NCT00989833|P3|Participant Flow|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266050|NCT00989833|P2|Participant Flow|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266051|NCT00989833|P1|Participant Flow|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266052|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266053|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266054|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266055|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266056|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266057|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
276866|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
266058|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266059|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266060|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266061|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266062|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266063|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266064|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266065|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266066|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266067|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266068|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266069|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266070|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266071|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266072|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266073|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266074|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266075|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266076|NCT00989833|E3|Reported Event|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
266077|NCT00989833|E2|Reported Event|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
266078|NCT00989833|E1|Reported Event|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
266079|NCT00989768|B1|Baseline|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
266080|NCT00989768|P1|Participant Flow|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
266081|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered two units to the other side of frontal region
266082|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
266083|NCT00989768|O2|Outcome|Botox ® 2U|Two units of Botox® was administered to the other side of the frontal region.
266084|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
266085|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
266086|NCT00989768|O1|Outcome|Dysport® 5U|Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
266087|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
266088|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
266089|NCT00989768|E1|Reported Event|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
266090|NCT00989664|B1|Baseline|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266091|NCT00989664|P1|Participant Flow|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266173|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266174|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266175|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266092|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266093|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266094|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266095|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266096|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266097|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266098|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266099|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266100|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
270386|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
266101|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266102|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266103|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266104|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266105|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266106|NCT00989664|O2|Outcome|LQCR|Participants treated with at least two chemotherapy regimens before enrolling in study BEX104504
266107|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266108|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266109|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266176|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266177|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266178|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266179|NCT00989235|E3|Reported Event|Abatacept 10mg/kg (Open-Label)|
266180|NCT00989235|E2|Reported Event|Abatacept 10mg/kg (ST)|
266181|NCT00989235|E1|Reported Event|Abatacept 5mg/kg (ST)|
266110|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266111|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266112|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266113|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
266114|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266115|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
266116|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266117|NCT00989664|E1|Reported Event|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
266118|NCT00989586|B3|Baseline|Total|Total of all reporting groups
266119|NCT00989586|B2|Baseline|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
266120|NCT00989586|B1|Baseline|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
266182|NCT00989196|B1|Baseline|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
266121|NCT00989586|P2|Participant Flow|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
266122|NCT00989586|P1|Participant Flow|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
266123|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
266124|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
266125|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
266126|NCT00989586|O2|Outcome|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
266127|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
266128|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
266129|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
266130|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
266131|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
266132|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
266133|NCT00989586|E1|Reported Event|All Patients From Phase I and Phase II|Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
266134|NCT00989235|B3|Baseline|Total|Total of all reporting groups
266135|NCT00989235|B2|Baseline|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266136|NCT00989235|B1|Baseline|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266137|NCT00989235|P2|Participant Flow|Abatacept (5 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
266138|NCT00989235|P1|Participant Flow|Abatacept (10 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
266139|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266140|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266141|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266142|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266143|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266144|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266145|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266146|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266147|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266148|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266149|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266150|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266151|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266152|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266153|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266154|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266155|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
266156|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
266157|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266158|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266159|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266160|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266161|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266162|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266163|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266164|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266165|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266166|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266167|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266168|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266169|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266170|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
266171|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
266172|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
276867|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
266183|NCT00989196|P2|Participant Flow|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266184|NCT00989196|P1|Participant Flow|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266185|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
266186|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
266187|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266188|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266189|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266190|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266191|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266192|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266193|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266194|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266195|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266196|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266197|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266198|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
266199|NCT00989196|O2|Outcome|Kogenate FS|Kogenate FS 50 IU/kg for PK dose
266200|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII 50 IU/kg for PK dose
266201|NCT00989196|E1|Reported Event|Human cl rhFVIII and Kogenate FS|All participants. Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK period. After the PK period all participants received Human-cl rhFVIII in the treatment period.
266202|NCT00989157|B3|Baseline|Total|Total of all reporting groups
266203|NCT00989157|B2|Baseline|Control|Subjects matched to the bariatric subjects via BMI, age and gender
266204|NCT00989157|B1|Baseline|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
266205|NCT00989157|P2|Participant Flow|Bariatric|One year post surgery
266206|NCT00989157|P1|Participant Flow|Control|Matched to bariatric subject via BMI, age and gender
266207|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
266208|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
266209|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
266210|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
266211|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
266212|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
266213|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
266214|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
266215|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender
266216|NCT00989157|O1|Outcome|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
266217|NCT00989157|E2|Reported Event|Control|Subjects matched to the bariatric subjects via BMI, age and gender
266218|NCT00989157|E1|Reported Event|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
266219|NCT00989092|B3|Baseline|Total|Total of all reporting groups
266309|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266220|NCT00989092|B2|Baseline|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266221|NCT00989092|B1|Baseline|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266222|NCT00989092|P2|Participant Flow|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266223|NCT00989092|P1|Participant Flow|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266224|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266225|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266226|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266227|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266228|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266229|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266230|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266231|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266232|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266233|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
270387|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
266234|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266235|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266236|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266237|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266238|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266239|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266240|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266241|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266242|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266243|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266244|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266245|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266246|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266247|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
270388|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
266248|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266249|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266250|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
266251|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
266252|NCT00989092|E3|Reported Event|Observation Arm Not Treated|Participants in the observation group who did not receive any darbepoetin alfa treatment.
266253|NCT00989092|E2|Reported Event|Observation Arm Treated|Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.
266254|NCT00989092|E1|Reported Event|Treatment Arm|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
266255|NCT00989014|B5|Baseline|Total|Total of all reporting groups
266256|NCT00989014|B4|Baseline|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
266257|NCT00989014|B3|Baseline|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
266258|NCT00989014|B2|Baseline|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
266259|NCT00989014|B1|Baseline|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
266260|NCT00989014|P4|Participant Flow|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
266261|NCT00989014|P3|Participant Flow|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
266262|NCT00989014|P2|Participant Flow|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
266263|NCT00989014|P1|Participant Flow|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
266264|NCT00989014|O4|Outcome|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
266265|NCT00989014|O3|Outcome|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
266266|NCT00989014|O2|Outcome|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
266267|NCT00989014|O1|Outcome|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
266268|NCT00989014|E4|Reported Event|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
266269|NCT00989014|E3|Reported Event|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
266270|NCT00989014|E2|Reported Event|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
266271|NCT00989014|E1|Reported Event|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
266272|NCT00988884|B3|Baseline|Total|Total of all reporting groups
266273|NCT00988884|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266274|NCT00988884|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266275|NCT00988884|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266276|NCT00988884|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266277|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266278|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266279|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
276868|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
266280|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266281|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266282|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266283|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266284|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266285|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266286|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266287|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266288|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266289|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266290|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266291|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266292|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266293|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266294|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266295|NCT00988884|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
266296|NCT00988884|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
266297|NCT00988832|B1|Baseline|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
266298|NCT00988832|P1|Participant Flow|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
266299|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266300|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266301|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266302|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266303|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266304|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266305|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266306|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266307|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266308|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
270389|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
266310|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266311|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266312|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266313|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266314|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266315|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266316|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266317|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266318|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266319|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266320|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266321|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266322|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266323|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266324|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266325|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266326|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266327|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
266328|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
266329|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
266330|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
266331|NCT00988832|E1|Reported Event|INFLIXIMAB, RECOMBINANT|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
266332|NCT00988637|B3|Baseline|Total|Total of all reporting groups
266333|NCT00988637|B2|Baseline|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266334|NCT00988637|B1|Baseline|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266335|NCT00988637|P2|Participant Flow|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266336|NCT00988637|P1|Participant Flow|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266337|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266338|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266339|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266340|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266341|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266342|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266343|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266344|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266345|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266346|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266347|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266348|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266349|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266350|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266351|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266352|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266353|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266354|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266355|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266356|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266357|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266358|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266359|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266360|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266361|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266362|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266363|NCT00988637|E2|Reported Event|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
266364|NCT00988637|E1|Reported Event|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
266365|NCT00988533|B1|Baseline|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266366|NCT00988533|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266367|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266368|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266369|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266370|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266371|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266372|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266373|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266374|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266375|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266376|NCT00988533|E1|Reported Event|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
266377|NCT00988429|B4|Baseline|Total|Total of all reporting groups
266378|NCT00988429|B3|Baseline|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
266379|NCT00988429|B2|Baseline|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
266380|NCT00988429|B1|Baseline|Placebo|Matching placebo tablets QD orally
266442|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266482|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266381|NCT00988429|P3|Participant Flow|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
266382|NCT00988429|P2|Participant Flow|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
266383|NCT00988429|P1|Participant Flow|Placebo|Matching placebo tablets QD orally
266384|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266385|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266386|NCT00988429|O1|Outcome|Placebo|Matching placebo tablets QD orally
266387|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266388|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266389|NCT00988429|O1|Outcome|Placebo (ITT Population)|Matching placebo tablets QD orally
266390|NCT00988429|E3|Reported Event|ESL 1200 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266391|NCT00988429|E2|Reported Event|ESL 800 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
266392|NCT00988429|E1|Reported Event|Placebo (Safety Population)|Matching placebo tablets QD orally
266393|NCT00988351|B3|Baseline|Total|Total of all reporting groups
266394|NCT00988351|B2|Baseline|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266395|NCT00988351|B1|Baseline|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266396|NCT00988351|P2|Participant Flow|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266397|NCT00988351|P1|Participant Flow|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266398|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266399|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266400|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266401|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266402|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266403|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266404|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266405|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266406|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266407|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266408|NCT00988351|E2|Reported Event|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
266409|NCT00988351|E1|Reported Event|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
266410|NCT00988247|B3|Baseline|Total|Total of all reporting groups
266411|NCT00988247|B2|Baseline|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266412|NCT00988247|B1|Baseline|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266413|NCT00988247|P2|Participant Flow|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266414|NCT00988247|P1|Participant Flow|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266415|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266416|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266417|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266418|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266419|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266420|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266421|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266422|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266423|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266424|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266425|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266426|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266427|NCT00988247|E2|Reported Event|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
266428|NCT00988247|E1|Reported Event|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
266429|NCT00988221|B4|Baseline|Total|Total of all reporting groups
266430|NCT00988221|B3|Baseline|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266431|NCT00988221|B2|Baseline|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266432|NCT00988221|B1|Baseline|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266433|NCT00988221|P4|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266434|NCT00988221|P3|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266435|NCT00988221|P2|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266436|NCT00988221|P1|Participant Flow|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266437|NCT00988221|O3|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266438|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266439|NCT00988221|O1|Outcome|Placebo to Tocilizumab|Patients received placebo to tocilizumab intravenously every 4 weeks.
266440|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266441|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
276869|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
266443|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266444|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266445|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266446|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266447|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266448|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266449|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266450|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266451|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266452|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266453|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266454|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266455|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266456|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266457|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266458|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266459|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266460|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266461|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266462|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266463|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266464|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266465|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266466|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266467|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266468|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266469|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266470|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266471|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266472|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266473|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266474|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266475|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266476|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266477|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266478|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266479|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266480|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266481|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
276870|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
266483|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266484|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266485|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266486|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266487|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266488|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266489|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266490|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266491|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266492|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266493|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266494|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266495|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266496|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266497|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266498|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266499|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266500|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266501|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266502|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266503|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266504|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266505|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266506|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266507|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266508|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266509|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266510|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266511|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266512|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266513|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266514|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266515|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266516|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266517|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266518|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266519|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266520|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266521|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
276871|NCT00959751|E2|Reported Event|Placebo|3 x 0 mg capsules, PRN
266522|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266523|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266524|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266525|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266526|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266527|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266528|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266529|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266530|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266531|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266532|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266533|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266534|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266535|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266536|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266537|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266538|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266539|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266540|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266541|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266542|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266543|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266544|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266545|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266546|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266547|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266548|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266549|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266550|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266551|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266552|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266553|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266554|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266555|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266556|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266557|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266558|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266559|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266560|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266561|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266562|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266563|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266564|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266565|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266566|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266567|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266568|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266569|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266816|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
266570|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266571|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266572|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266573|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266574|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266575|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266576|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266577|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266578|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266579|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266580|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266581|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266582|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266583|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266584|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266585|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266586|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266587|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266588|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266589|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266590|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266591|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266592|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266593|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266594|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266595|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266596|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266597|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266598|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266599|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266600|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
266601|NCT00988221|E5|Reported Event|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
266602|NCT00988221|E4|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266603|NCT00988221|E3|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
266604|NCT00988221|E2|Reported Event|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
266605|NCT00988221|E1|Reported Event|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
266606|NCT00988208|B3|Baseline|Total|Total of all reporting groups
266607|NCT00988208|B2|Baseline|Docetaxel + Prednisone + Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266608|NCT00988208|B1|Baseline|Oral Placebo + Docetaxel IV Day 1 + Prednisone (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266609|NCT00988208|P2|Participant Flow|Docetaxel/Prednisone/Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266610|NCT00988208|P1|Participant Flow|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266611|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1;5 mg prednisone orally twice each day (BID) each day of a 21 day treatment cycle
266612|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of a 21 days treatment cycle plus 75 mg/m^2 docetaxel intravenous (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) of a 21 day treatment cycle
266613|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266614|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266615|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266616|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266617|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266618|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266619|NCT00988208|E2|Reported Event|Lenalidomide/Docetaxel/Prednisone (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
266620|NCT00988208|E1|Reported Event|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: Identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel IV on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
266621|NCT00988169|B1|Baseline|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
266622|NCT00988169|P1|Participant Flow|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
266623|NCT00988169|O1|Outcome|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
266624|NCT00988169|E1|Reported Event|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
266625|NCT00988156|B3|Baseline|Total|Total of all reporting groups
266626|NCT00988156|B2|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
266627|NCT00988156|B1|Baseline|Placebo|Placebo matching placebo
266628|NCT00988156|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
266629|NCT00988156|P1|Participant Flow|Placebo|Placebo matching placebo
266630|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
266631|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
266632|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
266633|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
266634|NCT00988156|E2|Reported Event|Esl (Safety Set Part I)|
266635|NCT00988156|E1|Reported Event|Placebo (Safety Set Part I)|
266636|NCT00988143|B4|Baseline|Total|Total of all reporting groups
266637|NCT00988143|B3|Baseline|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266638|NCT00988143|B2|Baseline|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266639|NCT00988143|B1|Baseline|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266640|NCT00988143|P3|Participant Flow|Study Group 3 (QIV)|Participants received the Quadrivalent Influenza Vaccine
266641|NCT00988143|P2|Participant Flow|Study Group 2 (2008-2009 TIV)|Participants received the 2008-2009 Trivalent Influenza Vaccine
266642|NCT00988143|P1|Participant Flow|Study Group 1 (2009-2010 TIV)|Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
266643|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266644|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266645|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266646|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266647|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266648|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266649|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266650|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266651|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266652|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266653|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266654|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266655|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266656|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266657|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266658|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266659|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266660|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266661|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266662|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266663|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266664|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266665|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266666|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266667|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266668|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266669|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266670|NCT00988143|E3|Reported Event|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
266671|NCT00988143|E2|Reported Event|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
266672|NCT00988143|E1|Reported Event|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
266673|NCT00988117|B1|Baseline|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
266674|NCT00988117|P1|Participant Flow|Rivastigmine|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
266675|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
266676|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
266677|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
266678|NCT00988117|E2|Reported Event|Rivastigmine 9.5 mg/24 Hours|The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
266679|NCT00988117|E1|Reported Event|Rivastigmine 4.6mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.
266680|NCT00988091|B3|Baseline|Total|Total of all reporting groups
266681|NCT00988091|B2|Baseline|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266682|NCT00988091|B1|Baseline|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266683|NCT00988091|P2|Participant Flow|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266684|NCT00988091|P1|Participant Flow|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266704|NCT00988065|B2|Baseline|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266685|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266686|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266687|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266688|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266689|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266690|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266691|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266692|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266693|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266694|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266695|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266696|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266697|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
266698|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
266699|NCT00988091|E3|Reported Event|IA-BioHA: Open-label Period|Participants had the option of continuing into the open-label period in which their target knee received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) and they were followed for an additional 26 weeks.
266700|NCT00988091|E2|Reported Event|IA-BioHA: Double-blind Period|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
266701|NCT00988091|E1|Reported Event|IA-SA: Double-blind Period|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
266702|NCT00988065|B4|Baseline|Total|Total of all reporting groups
266703|NCT00988065|B3|Baseline|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
270390|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
266705|NCT00988065|B1|Baseline|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266706|NCT00988065|P3|Participant Flow|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266707|NCT00988065|P2|Participant Flow|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266708|NCT00988065|P1|Participant Flow|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266709|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266710|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266711|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266712|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266713|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266714|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266715|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266716|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266717|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266718|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266719|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266720|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266721|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266722|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266723|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266724|NCT00988065|E3|Reported Event|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266725|NCT00988065|E2|Reported Event|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266726|NCT00988065|E1|Reported Event|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
266727|NCT00987935|B10|Baseline|Total|Total of all reporting groups
266728|NCT00987935|B9|Baseline|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266729|NCT00987935|B8|Baseline|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266730|NCT00987935|B7|Baseline|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266731|NCT00987935|B6|Baseline|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266732|NCT00987935|B5|Baseline|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266733|NCT00987935|B4|Baseline|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266734|NCT00987935|B3|Baseline|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266735|NCT00987935|B2|Baseline|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266736|NCT00987935|B1|Baseline|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
266737|NCT00987935|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266815|NCT00987727|P1|Participant Flow|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
266738|NCT00987935|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266739|NCT00987935|P7|Participant Flow|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266740|NCT00987935|P6|Participant Flow|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266741|NCT00987935|P5|Participant Flow|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266742|NCT00987935|P4|Participant Flow|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266743|NCT00987935|P3|Participant Flow|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266744|NCT00987935|P2|Participant Flow|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266745|NCT00987935|P1|Participant Flow|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
266746|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266747|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266748|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266749|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266750|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266751|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266752|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266753|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266754|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266755|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266756|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266757|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266758|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
266759|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266760|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266761|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266762|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266763|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266764|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266765|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
277768|NCT00957242|O1|Outcome|Placebo|matched placebo
266766|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266767|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266768|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266769|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266770|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266771|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266772|NCT00987935|O1|Outcome|Phase I Group 1, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
266773|NCT00987935|O9|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266774|NCT00987935|O8|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266775|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266776|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266777|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266778|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266779|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266780|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
266781|NCT00987935|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
266782|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266783|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266784|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266785|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
266786|NCT00987935|O2|Outcome|Group 2|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266787|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
266788|NCT00987935|E9|Reported Event|Phase II Sorafenib, 400 mg Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
266789|NCT00987935|E8|Reported Event|Phase II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
266790|NCT00987935|E7|Reported Event|Phase I Group II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
266791|NCT00987935|E6|Reported Event|Phase I Group II Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
278554|NCT00953407|E4|Reported Event|Omafilcon A|Omafilcon A contact lens
266792|NCT00987935|E5|Reported Event|Phase I Group II Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
266793|NCT00987935|E4|Reported Event|Phase I Group II Nintedanib, 50 mg Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
266794|NCT00987935|E3|Reported Event|Phase I Group I Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
266795|NCT00987935|E2|Reported Event|Phase I Group I Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
266796|NCT00987935|E1|Reported Event|Phase I Group I Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
266797|NCT00987831|B4|Baseline|Total|Total of all reporting groups
266798|NCT00987831|B3|Baseline|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
266799|NCT00987831|B2|Baseline|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
266800|NCT00987831|B1|Baseline|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppresion vs themselves serving as their own control flaring later....not on immune suppression.
266801|NCT00987831|P3|Participant Flow|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
266802|NCT00987831|P2|Participant Flow|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
266803|NCT00987831|P1|Participant Flow|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
266804|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease is now defined as BILAG < 17 in cumulative score
266805|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease is now defined as total cumulative BILAG score >/= 17
266806|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease activity is defined as up to 3 BILAG B, no A, and SLEDAI </= 10.
266807|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease activity is defined as > 3 BILAG B, OR at least one BILAG A or SLEDAI > 10 OR Meets Definition for severe Flare on SELENA SLEDAI
266808|NCT00987831|E3|Reported Event|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
266809|NCT00987831|E2|Reported Event|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
266810|NCT00987831|E1|Reported Event|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
266811|NCT00987727|B3|Baseline|Total|Total of all reporting groups
266812|NCT00987727|B2|Baseline|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
266813|NCT00987727|B1|Baseline|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
266814|NCT00987727|P2|Participant Flow|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
270391|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
266817|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
266818|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
266819|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
266820|NCT00987727|E2|Reported Event|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
266821|NCT00987727|E1|Reported Event|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
266822|NCT00987623|B3|Baseline|Total|Total of all reporting groups
266823|NCT00987623|B2|Baseline|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266824|NCT00987623|B1|Baseline|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266825|NCT00987623|P2|Participant Flow|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266826|NCT00987623|P1|Participant Flow|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266827|NCT00987623|O2|Outcome|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266828|NCT00987623|O1|Outcome|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266829|NCT00987623|E2|Reported Event|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266830|NCT00987623|E1|Reported Event|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
266831|NCT00987558|B1|Baseline|Eslicarbazepine Acetate + Simvastatin|"Simvastatin 80 mg + eslicarbazepine acetate 800 mg~Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─ separated by a washout period of 3 weeks or more."
266832|NCT00987558|P2|Participant Flow|ESL, Then Simvastatin|Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
266833|NCT00987558|P1|Participant Flow|Simvastatin, Then ESL + Simvastatin|Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
266834|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
266835|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
266836|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
266837|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
266838|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
266839|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
266840|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
266841|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
266842|NCT00987558|E3|Reported Event|Eslicarbazepine Acetate + Simvastatin|Simvastatin 80 mg + eslicarbazepine acetate 800 mg
266843|NCT00987558|E2|Reported Event|Eslicarbazepine Acetate|eslicarbazepine acetate 800 mg
266844|NCT00987558|E1|Reported Event|Simvastatin|Simvastatin 80 mg
266845|NCT00987467|B1|Baseline|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
266846|NCT00987467|P1|Participant Flow|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
266847|NCT00987467|O1|Outcome|Topical Steroid Resistant/Dependant AKC|Patients with topical steroid resistant or dependant AKC were used for this study.
266848|NCT00987467|O1|Outcome|Patients With Steroid Resistant/ Dependant AKC.|Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
266849|NCT00987467|E1|Reported Event|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
266850|NCT00987415|B3|Baseline|Total|Total of all reporting groups
266851|NCT00987415|B2|Baseline|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266852|NCT00987415|B1|Baseline|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266853|NCT00987415|P2|Participant Flow|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266854|NCT00987415|P1|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
278555|NCT00953407|E3|Reported Event|Etafilcon A|Etafilcon A contact lens
266855|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266856|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266857|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266858|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266859|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266860|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266861|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266862|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266863|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266864|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266865|NCT00987415|E2|Reported Event|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266866|NCT00987415|E1|Reported Event|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
266867|NCT00987402|B3|Baseline|Total|Total of all reporting groups
266868|NCT00987402|B2|Baseline|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
266869|NCT00987402|B1|Baseline|Plain Soap and Water|Surgical hand preparation with plain soap and water
266870|NCT00987402|P2|Participant Flow|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
266871|NCT00987402|P1|Participant Flow|Plain Soap and Water|Surgical hand preparation with plain soap and water
266872|NCT00987402|O2|Outcome|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
266873|NCT00987402|O1|Outcome|Plain Soap and Water|Surgical hand preparation with plain soap and water
266874|NCT00987402|E2|Reported Event|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
266875|NCT00987402|E1|Reported Event|Plain Soap and Water|Surgical hand preparation with plain soap and water
266876|NCT00987337|B4|Baseline|Total|Total of all reporting groups
266877|NCT00987337|B3|Baseline|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266878|NCT00987337|B2|Baseline|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266879|NCT00987337|B1|Baseline|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266880|NCT00987337|P3|Participant Flow|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266910|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
267333|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
266881|NCT00987337|P2|Participant Flow|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266882|NCT00987337|P1|Participant Flow|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266883|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266884|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266885|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266886|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266887|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266888|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266889|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266911|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
267026|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
266890|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266891|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266892|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266893|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266894|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266895|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266896|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266897|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266898|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266899|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
267334|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
266900|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266901|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266902|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266903|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266904|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266905|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266906|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266907|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266908|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266909|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
267335|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
266912|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
266913|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266914|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266915|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266916|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266917|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266918|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266919|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266920|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266921|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266972|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
279817|NCT00950729|E1|Reported Event|Healthy Subjects|
266922|NCT00987337|E3|Reported Event|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
266923|NCT00987337|E2|Reported Event|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266924|NCT00987337|E1|Reported Event|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
266925|NCT00986999|B1|Baseline|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266926|NCT00986999|P1|Participant Flow|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266927|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266928|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266929|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266930|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266931|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266932|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266933|NCT00986999|E1|Reported Event|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
266934|NCT00986986|B3|Baseline|Total|Total of all reporting groups
266935|NCT00986986|B2|Baseline|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266936|NCT00986986|B1|Baseline|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
266937|NCT00986986|P2|Participant Flow|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266938|NCT00986986|P1|Participant Flow|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
266939|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266940|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
266941|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266942|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
266943|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266944|NCT00986986|O1|Outcome|Extended Release Niacin|HIV infected individuals receiving extended release niacin
266945|NCT00986986|E2|Reported Event|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
266946|NCT00986986|E1|Reported Event|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
266947|NCT00986973|B1|Baseline|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day KUVAN for four months.
266948|NCT00986973|P1|Participant Flow|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266973|NCT00986921|O2|Outcome|Mifepristone|Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
266974|NCT00986921|O1|Outcome|Standard Osmotic Dilators|Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
266949|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266950|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266951|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266952|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266953|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266954|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
266955|NCT00986973|O1|Outcome|Sapropterin (KUVAN) Therapy|All subjects received KUVAN at a dose of 20/mg/kg/day for four months. Blood Phe levels were measured drawn before therapy and 4 months after starting therapy.
266956|NCT00986973|E1|Reported Event|Sapropterin (KUVAN) Therapy|All subjects will received KUVAN therapy 20 mg/kg/day for four months.
266957|NCT00986960|B3|Baseline|Total|Total of all reporting groups
266958|NCT00986960|B2|Baseline|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
266959|NCT00986960|B1|Baseline|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
266960|NCT00986960|P2|Participant Flow|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
266961|NCT00986960|P1|Participant Flow|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
266962|NCT00986960|O2|Outcome|Placebo|Saline: I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
266963|NCT00986960|O1|Outcome|Adrenocorticotropin Hormone|repository corticotropin injection: IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
266964|NCT00986960|E2|Reported Event|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
266965|NCT00986960|E1|Reported Event|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
266966|NCT00986921|B3|Baseline|Total|Total of all reporting groups
266967|NCT00986921|B2|Baseline|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266968|NCT00986921|B1|Baseline|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266969|NCT00986921|P2|Participant Flow|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique."
266970|NCT00986921|P1|Participant Flow|Standard Osmotic Dilator Insertion|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique."
266971|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
267024|NCT00986583|P2|Participant Flow|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
266975|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used.~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266976|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266977|NCT00986921|E2|Reported Event|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266978|NCT00986921|E1|Reported Event|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
266979|NCT00986856|B3|Baseline|Total|Total of all reporting groups
266980|NCT00986856|B2|Baseline|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266981|NCT00986856|B1|Baseline|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266982|NCT00986856|P2|Participant Flow|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266983|NCT00986856|P1|Participant Flow|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266984|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266985|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266986|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266987|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266988|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266989|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266990|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266991|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266992|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266993|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266994|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266995|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266996|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266997|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
266998|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
266999|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
267000|NCT00986856|E2|Reported Event|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
267001|NCT00986856|E1|Reported Event|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
267002|NCT00986674|B4|Baseline|Total|Total of all reporting groups
267003|NCT00986674|B3|Baseline|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267004|NCT00986674|B2|Baseline|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
267005|NCT00986674|B1|Baseline|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267006|NCT00986674|P3|Participant Flow|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267007|NCT00986674|P2|Participant Flow|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
267025|NCT00986583|P1|Participant Flow|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267336|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267008|NCT00986674|P1|Participant Flow|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267009|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267010|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
267011|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267012|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267013|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
267014|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267015|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267016|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
267017|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
267018|NCT00986674|E3|Reported Event|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
267019|NCT00986674|E2|Reported Event|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
267020|NCT00986674|E1|Reported Event|Arm I (Carboplatin, Paclitaxel, Cetuximab)|Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
267021|NCT00986583|B3|Baseline|Total|Total of all reporting groups
267022|NCT00986583|B2|Baseline|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267023|NCT00986583|B1|Baseline|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267027|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267028|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267029|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267030|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267031|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267032|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267033|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267034|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267035|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
267036|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267037|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
267038|NCT00986583|E2|Reported Event|Nonstatin Users|
267039|NCT00986583|E1|Reported Event|Statin Users|
267040|NCT00986570|B1|Baseline|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
267041|NCT00986570|P1|Participant Flow|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
267042|NCT00986570|O1|Outcome|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
267043|NCT00986570|E1|Reported Event|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
267044|NCT00986544|B3|Baseline|Total|Total of all reporting groups
267045|NCT00986544|B2|Baseline|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
267046|NCT00986544|B1|Baseline|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
267047|NCT00986544|P2|Participant Flow|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
267048|NCT00986544|P1|Participant Flow|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
267049|NCT00986544|O2|Outcome|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
267050|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
267051|NCT00986544|O2|Outcome|Drain|Drain positioned in the subhepatic space after laparoscopic cholecystectomy
267052|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
267053|NCT00986544|E2|Reported Event|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
267054|NCT00986544|E1|Reported Event|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
267055|NCT00986479|B3|Baseline|Total|Total of all reporting groups
267056|NCT00986479|B2|Baseline|Placebo/AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267057|NCT00986479|B1|Baseline|AZD6765 (150 mg)/ Placebo|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267058|NCT00986479|P2|Participant Flow|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267059|NCT00986479|P1|Participant Flow|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267060|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267061|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
280019|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
267062|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267063|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267064|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267065|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267066|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267067|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267068|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267069|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267070|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267071|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267072|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267073|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267074|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267075|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267076|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267077|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267078|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267079|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267080|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267081|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267082|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267083|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267084|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267185|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267085|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267086|NCT00986479|E2|Reported Event|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
267087|NCT00986479|E1|Reported Event|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
267088|NCT00986453|B1|Baseline|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
267089|NCT00986453|P1|Participant Flow|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
267090|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267091|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267092|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267093|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267094|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267095|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267096|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267097|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267098|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267099|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267100|NCT00986453|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
267101|NCT00986453|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
267102|NCT00986427|B3|Baseline|Total|Total of all reporting groups
267103|NCT00986427|B2|Baseline|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267104|NCT00986427|B1|Baseline|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267105|NCT00986427|P2|Participant Flow|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267106|NCT00986427|P1|Participant Flow|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267107|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267108|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267109|NCT00986427|O4|Outcome|Refresh® Dry Eye Untreated Nail|Refresh® Dry Eye Therapy Untreated Nail
267110|NCT00986427|O3|Outcome|Refresh® Dry Eye Treated Nail|Refresh® Dry Eye Therapy Treated Nail
267111|NCT00986427|O2|Outcome|Restasis® Arm Untreated Nail|Restasis® Untreated Nail
267112|NCT00986427|O1|Outcome|Restasis® Arm Treated Nail|Restasis® Treated Nail
267113|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267114|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267115|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267116|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267117|NCT00986427|E2|Reported Event|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267118|NCT00986427|E1|Reported Event|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
267119|NCT00986401|B3|Baseline|Total|Total of all reporting groups
267120|NCT00986401|B2|Baseline|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
267121|NCT00986401|B1|Baseline|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
267186|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267122|NCT00986401|P2|Participant Flow|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
267123|NCT00986401|P1|Participant Flow|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
267124|NCT00986401|O2|Outcome|Sanctura XR® + Glucophage®|Sanctura XR® + Glucophage®
267125|NCT00986401|O1|Outcome|Sanctura XR®|Sanctura XR®
267126|NCT00986401|O2|Outcome|Glucophage® + Sanctura XR®|Glucophage® + Sanctura XR®
267127|NCT00986401|O1|Outcome|Glucophage®|Glucophage®
267128|NCT00986401|E3|Reported Event|Sanctura XR® in Combination With Glucophage®|Sanctura XR® in combination with Glucophage®
267129|NCT00986401|E2|Reported Event|Sanctura XR®|Sanctura XR®
267130|NCT00986401|E1|Reported Event|Glucophage®|Glucophage®
267131|NCT00986362|B3|Baseline|Total|Total of all reporting groups
267132|NCT00986362|B2|Baseline|Placebo|Placebo : Placebo intravitreal injection
267133|NCT00986362|B1|Baseline|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
267134|NCT00986362|P2|Participant Flow|Placebo|Placebo : Placebo intravitreal injection
267135|NCT00986362|P1|Participant Flow|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
267136|NCT00986362|O2|Outcome|Placebo|Placebo : Placebo intravitreal injection
267137|NCT00986362|O1|Outcome|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
267138|NCT00986362|E2|Reported Event|Placebo|Placebo : Placebo intravitreal injection
267139|NCT00986362|E1|Reported Event|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
267140|NCT00986349|B1|Baseline|EndoBarrier Liner Device|EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
267141|NCT00986349|P1|Participant Flow|EndoBarrier Liner Device|Enrolled Subjects
267142|NCT00986349|O1|Outcome|Diabetes|"Single Arm~EndoBarrier Liner: 52 week treatment of EnoBarrier Liner"
267143|NCT00986349|O1|Outcome|EndoBarrier Liner Device|52 week treatment of EndoBarrier Liner
267144|NCT00986349|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects who completed 12-month implant duration
267145|NCT00986349|O2|Outcome|Decrease in Glucose-Lowering Meds|Subjects who completed 12-month implant duration
267146|NCT00986349|O1|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjecst who completed 12 month implant duration
267147|NCT00986349|O5|Outcome|EndoBarrier Liner Device % at 52 Weeks|HbA1c
267148|NCT00986349|O4|Outcome|EndoBarrier Liner Device % at 9 Months|HbA1c
267149|NCT00986349|O3|Outcome|EndoBarrier Liner Device % at 6 Months|HbA1c
267150|NCT00986349|O2|Outcome|EndoBarrier Liner Device at 3 Months|HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
267151|NCT00986349|O1|Outcome|EndoBarrier Liner Device at Baseline|HbA1c %
267152|NCT00986349|E1|Reported Event|EndoBarrier Liner Device|All subjects who had a device attempted to be implanted. N = 23
267153|NCT00986258|B1|Baseline|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267154|NCT00986258|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267155|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
267156|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
267157|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
267158|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
267159|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
267160|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
267161|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
267162|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
267163|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
267187|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267337|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267164|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267165|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267166|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267167|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267168|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267169|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267170|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267171|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267172|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267188|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267173|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267174|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267175|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267176|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267177|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267178|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267179|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267180|NCT00986258|E1|Reported Event|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
267181|NCT00986245|B1|Baseline|Entire Study Population|Includes groups randomized to receive once daily first and twice daily first.
267182|NCT00986245|P2|Participant Flow|Ropinirole PR-Twice Daily First, Then Once Daily|Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
267183|NCT00986245|P1|Participant Flow|Ropinirole PR-Once Daily First, Then Twice Daily|Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)
267184|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267330|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267189|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267190|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267191|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267192|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267193|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267194|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267195|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267196|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267197|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267198|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267199|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267200|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267201|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267202|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267203|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267204|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267205|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267206|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267207|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267208|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
267209|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
267210|NCT00986245|O3|Outcome|No Preference|No preference group
267211|NCT00986245|O2|Outcome|Twice-daily|Twice-daily preferred group
267212|NCT00986245|O1|Outcome|Once-daily|Once-daily preferred group
267213|NCT00986245|E2|Reported Event|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267214|NCT00986245|E1|Reported Event|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
267215|NCT00986232|B5|Baseline|Total|Total of all reporting groups
267216|NCT00986232|B4|Baseline|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267217|NCT00986232|B3|Baseline|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267218|NCT00986232|B2|Baseline|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267219|NCT00986232|B1|Baseline|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267220|NCT00986232|P4|Participant Flow|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267221|NCT00986232|P3|Participant Flow|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267222|NCT00986232|P2|Participant Flow|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267223|NCT00986232|P1|Participant Flow|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267224|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267225|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267226|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267331|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267227|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267228|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267229|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267230|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267231|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267232|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267233|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267234|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267235|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267236|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267237|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267238|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267239|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267240|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267241|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267242|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267243|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267244|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267245|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267246|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267247|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267248|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267249|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267250|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267251|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267252|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267253|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267254|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267255|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267256|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267257|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267258|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267259|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267260|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267261|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267262|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267263|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267264|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267265|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267266|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267267|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267268|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267269|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267270|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267271|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267272|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267273|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267274|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267275|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267276|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267277|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267278|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267279|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267280|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267281|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267282|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267283|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267284|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267285|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267332|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
280020|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
267286|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267287|NCT00986232|E7|Reported Event|ProQuad (High Dose) After Injection 2|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267288|NCT00986232|E6|Reported Event|ProQuad (Middle Dose) After Injection 2|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267289|NCT00986232|E5|Reported Event|ProQuad (Low Dose) After Injection 2|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267290|NCT00986232|E4|Reported Event|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
267291|NCT00986232|E3|Reported Event|ProQuad (High Dose) After Injection 1|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267292|NCT00986232|E2|Reported Event|ProQuad (Middle Dose) After Injection 1|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267293|NCT00986232|E1|Reported Event|ProQuad (Low Dose) After Injection 1|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
267294|NCT00986180|B3|Baseline|Total|Total of all reporting groups
267295|NCT00986180|B2|Baseline|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267296|NCT00986180|B1|Baseline|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267297|NCT00986180|P2|Participant Flow|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267298|NCT00986180|P1|Participant Flow|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267299|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267300|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267301|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267302|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267303|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267304|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267305|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267306|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267307|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267308|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267309|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267310|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267311|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267312|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267313|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267314|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267315|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267316|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267317|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267318|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267319|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267320|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267321|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267322|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267323|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267324|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267325|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267326|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267327|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267328|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267329|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267338|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267339|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267340|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267341|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267342|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267343|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267344|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267345|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267346|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267347|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267348|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267349|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267350|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267351|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267352|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267353|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267354|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267355|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267356|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267357|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267358|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267359|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267360|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267361|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267362|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267363|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267364|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267365|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267366|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267367|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267368|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267369|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267370|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267371|NCT00986180|E2|Reported Event|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
267372|NCT00986180|E1|Reported Event|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
267373|NCT00986154|B3|Baseline|Total|Total of all reporting groups
267374|NCT00986154|B2|Baseline|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267375|NCT00986154|B1|Baseline|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267376|NCT00986154|P2|Participant Flow|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267377|NCT00986154|P1|Participant Flow|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267378|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267379|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267380|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267381|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267382|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267383|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267384|NCT00986154|E2|Reported Event|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
267385|NCT00986154|E1|Reported Event|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
267386|NCT00986102|B5|Baseline|Total|Total of all reporting groups
267387|NCT00986102|B4|Baseline|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267388|NCT00986102|B3|Baseline|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267389|NCT00986102|B2|Baseline|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267390|NCT00986102|B1|Baseline|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267391|NCT00986102|P4|Participant Flow|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267392|NCT00986102|P3|Participant Flow|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267393|NCT00986102|P2|Participant Flow|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267394|NCT00986102|P1|Participant Flow|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267395|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267396|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267397|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267398|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267399|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267400|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267401|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267402|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267403|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267404|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267405|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267406|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267407|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267408|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267409|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267410|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267411|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267412|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267413|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267414|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267415|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267416|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267417|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267418|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267419|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267420|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267421|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267422|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267423|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267424|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267425|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267426|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267427|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267428|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267429|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267430|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267431|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267432|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267433|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267434|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267435|NCT00986102|E4|Reported Event|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
267436|NCT00986102|E3|Reported Event|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
267437|NCT00986102|E2|Reported Event|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267438|NCT00986102|E1|Reported Event|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
267439|NCT00985985|B5|Baseline|Total|Total of all reporting groups
267440|NCT00985985|B4|Baseline|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
267441|NCT00985985|B3|Baseline|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
267442|NCT00985985|B2|Baseline|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
267443|NCT00985985|B1|Baseline|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
267444|NCT00985985|P4|Participant Flow|Placebo Lozenge (High Dependence Smoke|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
267475|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
268094|NCT00984867|E1|Reported Event|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
267445|NCT00985985|P3|Participant Flow|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
267446|NCT00985985|P2|Participant Flow|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
267447|NCT00985985|P1|Participant Flow|Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
267448|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
267449|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
267450|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine, orally.
267451|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
267452|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267453|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267454|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267455|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
267456|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267457|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267458|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267459|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
267460|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine, orally.
267461|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267462|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267463|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
267464|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267465|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267466|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267467|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
267468|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267469|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267470|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267471|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
267472|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267473|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267474|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267604|NCT00985725|E2|Reported Event|Placebo|Administered orally once-daily for 9 weeks.
267476|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
267477|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
267478|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
267479|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
267480|NCT00985985|E4|Reported Event|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
267481|NCT00985985|E3|Reported Event|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
267482|NCT00985985|E2|Reported Event|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
267483|NCT00985985|E1|Reported Event|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
267484|NCT00985959|B4|Baseline|Total|Total of all reporting groups
267485|NCT00985959|B3|Baseline|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267486|NCT00985959|B2|Baseline|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267487|NCT00985959|B1|Baseline|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267488|NCT00985959|P3|Participant Flow|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267489|NCT00985959|P2|Participant Flow|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267490|NCT00985959|P1|Participant Flow|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267491|NCT00985959|O1|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267492|NCT00985959|O1|Outcome|Prednisolone|Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267493|NCT00985959|O1|Outcome|Melphalan|Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267494|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267495|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267496|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267497|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267498|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267499|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267500|NCT00985959|O5|Outcome|Total|Participants from both Phase I and Phase II
267501|NCT00985959|O4|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267502|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267503|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267504|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267505|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
280021|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
267506|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267507|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267508|NCT00985959|E4|Reported Event|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
267509|NCT00985959|E3|Reported Event|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267510|NCT00985959|E2|Reported Event|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267511|NCT00985959|E1|Reported Event|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
267512|NCT00985829|B1|Baseline|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
267513|NCT00985829|P1|Participant Flow|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
267514|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
267515|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
267516|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
267517|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
267518|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
267519|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
267520|NCT00985829|E1|Reported Event|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
267521|NCT00985790|B3|Baseline|Total|Total of all reporting groups
267522|NCT00985790|B2|Baseline|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267523|NCT00985790|B1|Baseline|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267524|NCT00985790|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267525|NCT00985790|P1|Participant Flow|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267526|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267527|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267605|NCT00985725|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267606|NCT00985712|B3|Baseline|Total|Total of all reporting groups
267528|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267529|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267530|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267531|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267532|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267533|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267534|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267535|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267536|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267537|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267538|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267539|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267540|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267541|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267607|NCT00985712|B2|Baseline|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267542|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267543|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267544|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267545|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267546|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267547|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267548|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267549|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267550|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267551|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267552|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267553|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267554|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267555|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267556|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267557|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267558|NCT00985790|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
267559|NCT00985790|E1|Reported Event|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
267560|NCT00985738|B3|Baseline|Total|Total of all reporting groups
267561|NCT00985738|B2|Baseline|Placebo|This group received a placebo followed by 3D mapping biopsy.
267562|NCT00985738|B1|Baseline|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
267563|NCT00985738|P2|Participant Flow|Placebo|This group received a placebo followed by 3D mapping biopsy.
267564|NCT00985738|P1|Participant Flow|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
267565|NCT00985738|O2|Outcome|Placebo|This group received a placebo followed by 3D mapping biopsy.
267566|NCT00985738|O1|Outcome|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
267567|NCT00985738|E2|Reported Event|Placebo|This group received a placebo followed by 3D mapping biopsy.
267568|NCT00985738|E1|Reported Event|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
267569|NCT00985725|B3|Baseline|Total|Total of all reporting groups
267570|NCT00985725|B2|Baseline|Placebo|Administered orally once-daily for 9 weeks.
267571|NCT00985725|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267572|NCT00985725|P2|Participant Flow|Placebo|Administered orally once-daily for 9 weeks.
267573|NCT00985725|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267574|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267575|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267576|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267577|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267578|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267579|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267580|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267581|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267582|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267583|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267584|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267585|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267586|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267587|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267588|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267589|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267590|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267591|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267592|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267593|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267594|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267595|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267596|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267597|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267598|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267599|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267600|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267601|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267602|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
267603|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
267608|NCT00985712|B1|Baseline|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267609|NCT00985712|P2|Participant Flow|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267610|NCT00985712|P1|Participant Flow|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267611|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267612|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267613|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267614|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267615|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267616|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267617|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267618|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267619|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267620|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267621|NCT00985712|E2|Reported Event|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
267622|NCT00985712|E1|Reported Event|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
267623|NCT00985686|B5|Baseline|Total|Total of all reporting groups
267624|NCT00985686|B4|Baseline|Waitlist Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the waitlist arm.
267625|NCT00985686|B3|Baseline|Waitlist Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the waitlist arm.
267626|NCT00985686|B2|Baseline|Study Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the study arm.
267627|NCT00985686|B1|Baseline|Study Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the study arm.
267628|NCT00985686|P4|Participant Flow|Waitlist Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
267629|NCT00985686|P3|Participant Flow|Waitlist Arm, Younger Subgroup|"Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
267630|NCT00985686|P2|Participant Flow|Study Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
267631|NCT00985686|P1|Participant Flow|Study Arm, Younger Subgroup|"Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
268660|NCT00983489|P1|Participant Flow|Counselling|counselling: Breast feeding counselling will be done to mothers
267632|NCT00985686|O1|Outcome|Older Subgroup (19-24 Years of Age)|Subgroup of participants 19-24 years of age. Participants were randomized into the Study and Waitlist Arms.
267633|NCT00985686|O1|Outcome|Younger Subgroup (13-18 Years of Age)|Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
267634|NCT00985686|E4|Reported Event|Waitlist Arm, Older Subgroup|Participants 19-24 years of age randomized into the wait list group
267635|NCT00985686|E3|Reported Event|Waitlist Arm, Younger Subgroup|Participants 13-18 years of age randomized into the waitlist group
267636|NCT00985686|E2|Reported Event|Study Arm, Older Subgroup|Participants 19-24 years of age randomized into the study group
267637|NCT00985686|E1|Reported Event|Study Arm, Younger Subgroup|Participants 13-18 years of age randomized into the study group
267638|NCT00985673|B7|Baseline|Total|Total of all reporting groups
267639|NCT00985673|B6|Baseline|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267640|NCT00985673|B5|Baseline|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267641|NCT00985673|B4|Baseline|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267642|NCT00985673|B3|Baseline|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267643|NCT00985673|B2|Baseline|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267644|NCT00985673|B1|Baseline|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267645|NCT00985673|P6|Participant Flow|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267646|NCT00985673|P5|Participant Flow|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267647|NCT00985673|P4|Participant Flow|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267648|NCT00985673|P3|Participant Flow|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267649|NCT00985673|P2|Participant Flow|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267650|NCT00985673|P1|Participant Flow|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267651|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268661|NCT00983489|O3|Outcome|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
267652|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267653|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267654|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267655|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267656|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267657|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267658|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267659|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267660|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267661|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267662|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267663|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267664|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267665|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267666|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268095|NCT00984815|B1|Baseline|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
267667|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267668|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267669|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267670|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267671|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267672|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267673|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267674|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267675|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267676|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267677|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267678|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267679|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267680|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267681|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267913|NCT00985504|P1|Participant Flow|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267682|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267683|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267684|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267685|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267686|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267687|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267688|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267689|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267690|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267691|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267692|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267693|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267694|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267695|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267696|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268242|NCT00984334|E4|Reported Event|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
267697|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267698|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267699|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267700|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267701|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267702|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267703|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267704|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267705|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267706|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267707|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267708|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267709|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267710|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267711|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267914|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267712|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267713|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267714|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267715|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267716|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267717|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267718|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267719|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267720|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267721|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267722|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267723|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267724|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267725|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267726|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267920|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267727|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267728|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267729|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267730|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267731|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267732|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267733|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267734|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267735|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267736|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267737|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267738|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267739|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267740|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267741|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268003|NCT00985166|E2|Reported Event|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267742|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267743|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267744|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267745|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267746|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267747|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267748|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267749|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267750|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267751|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267752|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267753|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267754|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267755|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267756|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267915|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267757|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267758|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267759|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267760|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267761|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267762|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267763|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267764|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267765|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267766|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267767|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267768|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267769|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267770|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267771|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268004|NCT00985166|E1|Reported Event|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
267772|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267773|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267774|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267775|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267776|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267777|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267778|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267779|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267780|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267781|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267782|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267783|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267784|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267785|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267786|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267916|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267787|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267788|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267789|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267790|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267791|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267792|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267793|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267794|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267795|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267796|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267797|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267798|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267799|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267800|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267801|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268005|NCT00985153|B5|Baseline|Total|Total of all reporting groups
270392|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
267802|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267803|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267804|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267805|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267806|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267807|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267808|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267809|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267810|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267811|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267812|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267813|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267814|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267815|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267816|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267917|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267817|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267818|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267819|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267820|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267821|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267822|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267823|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267824|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267825|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267826|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267827|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267828|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267829|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267830|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267831|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268006|NCT00985153|B4|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
267832|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267833|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267834|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267835|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267836|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267837|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267838|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267839|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267840|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267841|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267842|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267843|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267844|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267845|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267846|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267918|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267847|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267848|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267849|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267850|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267851|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267852|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267853|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267854|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267855|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267856|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267857|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267858|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267859|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267860|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267861|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268091|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
267862|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267863|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267864|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267865|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267866|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267867|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267868|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267869|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267870|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267871|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267872|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267873|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267874|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267875|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267876|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267919|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267877|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267878|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267879|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267880|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267881|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267882|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267883|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267884|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267885|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267886|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267887|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267888|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267889|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267890|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267891|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
268092|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin
267892|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267893|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267894|NCT00985673|E6|Reported Event|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267895|NCT00985673|E5|Reported Event|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267896|NCT00985673|E4|Reported Event|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267897|NCT00985673|E3|Reported Event|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267898|NCT00985673|E2|Reported Event|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267899|NCT00985673|E1|Reported Event|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
267900|NCT00985543|B1|Baseline|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
267901|NCT00985543|P1|Participant Flow|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
267902|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
267903|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
267904|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
267905|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
267906|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
267907|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
267908|NCT00985543|E1|Reported Event|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
267909|NCT00985504|B3|Baseline|Total|Total of all reporting groups
267910|NCT00985504|B2|Baseline|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267911|NCT00985504|B1|Baseline|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267912|NCT00985504|P2|Participant Flow|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
280022|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
267921|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267922|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267923|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267924|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267925|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267926|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267927|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267928|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267929|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267930|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267931|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267932|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267933|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267934|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267935|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267936|NCT00985504|E2|Reported Event|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267937|NCT00985504|E1|Reported Event|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
267938|NCT00985491|B1|Baseline|EndoBarrier Liner Device|"46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
267939|NCT00985491|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
267940|NCT00985491|O1|Outcome|Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
267941|NCT00985491|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
267942|NCT00985491|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
267943|NCT00985439|B5|Baseline|Total|Total of all reporting groups
267944|NCT00985439|B4|Baseline|Placebo|
267945|NCT00985439|B3|Baseline|Celecoxib 400 mg|
267946|NCT00985439|B2|Baseline|Diclofenac Test (Upper Dose)|
267947|NCT00985439|B1|Baseline|Diclofenac Test (Lower Dose)|
267948|NCT00985439|P4|Participant Flow|Placebo|
267949|NCT00985439|P3|Participant Flow|Celecoxib 400 mg|
267950|NCT00985439|P2|Participant Flow|Diclofenac Test (Upper Dose)|
267951|NCT00985439|P1|Participant Flow|Diclofenac Test (Lower Dose)|
267952|NCT00985439|O4|Outcome|Placebo|
267953|NCT00985439|O3|Outcome|Celecoxib 400 mg|
267954|NCT00985439|O2|Outcome|Diclofenac Test (Upper Dose)|35-mg
267955|NCT00985439|O1|Outcome|Diclofenac Test (Lower Dose)|18-mg
267956|NCT00985439|E4|Reported Event|Placebo|
267957|NCT00985439|E3|Reported Event|Celecoxib 400 mg|
267958|NCT00985439|E2|Reported Event|Diclofenac Test (Upper Dose)|
267959|NCT00985439|E1|Reported Event|Diclofenac Test (Lower Dose)|
267960|NCT00985257|B1|Baseline|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
267961|NCT00985257|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
267962|NCT00985257|O1|Outcome|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
267963|NCT00985257|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
267964|NCT00985231|B3|Baseline|Total|Total of all reporting groups
267965|NCT00985231|B2|Baseline|SofLens59 Contact Lens|
267966|NCT00985231|B1|Baseline|PureVision Multi-Focal Contact Lenses|
267967|NCT00985231|P2|Participant Flow|SofLens59 Contact Lens|
267968|NCT00985231|P1|Participant Flow|PureVision Multi-Focal Contact Lenses|
267969|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
267970|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
267971|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
267972|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
267973|NCT00985231|E2|Reported Event|SofLens59 Contact Lens|
267974|NCT00985231|E1|Reported Event|PureVision Multi-Focal Contact Lenses|
267975|NCT00985192|B1|Baseline|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267976|NCT00985192|P1|Participant Flow|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267977|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267978|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267979|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267980|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267981|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267982|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267983|NCT00985192|E1|Reported Event|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
267984|NCT00985166|B4|Baseline|Total|Total of all reporting groups
267985|NCT00985166|B3|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
267986|NCT00985166|B2|Baseline|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267987|NCT00985166|B1|Baseline|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
267988|NCT00985166|P3|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
267989|NCT00985166|P2|Participant Flow|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267990|NCT00985166|P1|Participant Flow|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
267991|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
267992|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267993|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
267994|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
267995|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267996|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
267997|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
267998|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
267999|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
268000|NCT00985166|O2|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
268001|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
268002|NCT00985166|E3|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
268007|NCT00985153|B3|Baseline|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268008|NCT00985153|B2|Baseline|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268009|NCT00985153|B1|Baseline|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268010|NCT00985153|P4|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268011|NCT00985153|P3|Participant Flow|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268012|NCT00985153|P2|Participant Flow|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268013|NCT00985153|P1|Participant Flow|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268014|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268015|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268016|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268017|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268018|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268019|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268020|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268021|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268022|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268023|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268024|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268025|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268026|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268027|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268028|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268029|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268030|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268031|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268032|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268033|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268034|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268035|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268036|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268037|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268038|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268039|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268040|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268093|NCT00984867|E2|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
268041|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268042|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268043|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268044|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268045|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268046|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268047|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268048|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268049|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268050|NCT00985153|E4|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
268051|NCT00985153|E3|Reported Event|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
268052|NCT00985153|E2|Reported Event|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
268053|NCT00985153|E1|Reported Event|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
268054|NCT00985114|B3|Baseline|Total|Total of all reporting groups
268055|NCT00985114|B2|Baseline|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
268056|NCT00985114|B1|Baseline|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
268057|NCT00985114|P2|Participant Flow|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
268058|NCT00985114|P1|Participant Flow|EndoBarrier Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
268059|NCT00985114|O2|Outcome|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
268060|NCT00985114|O1|Outcome|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
268061|NCT00985114|E2|Reported Event|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
268062|NCT00985114|E1|Reported Event|Device and Cross Over|"EndoBarrier~EndoBarrier: EndoBarrier implant"
268063|NCT00985010|B3|Baseline|Total|Total of all reporting groups
268064|NCT00985010|B2|Baseline|Males|Brain death
268065|NCT00985010|B1|Baseline|Females|Brain death
268066|NCT00985010|P2|Participant Flow|Males|Brain death
268067|NCT00985010|P1|Participant Flow|Females|Brain death
268068|NCT00985010|O2|Outcome|Males|Brain death
268069|NCT00985010|O1|Outcome|Females|Brain death
268070|NCT00985010|O2|Outcome|Males|Brain death
268071|NCT00985010|O1|Outcome|Females|Brain death
268072|NCT00985010|E2|Reported Event|Males|Brain death
268073|NCT00985010|E1|Reported Event|Females|Brain death
268074|NCT00984867|B3|Baseline|Total|Total of all reporting groups
268075|NCT00984867|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
268076|NCT00984867|B1|Baseline|Placebo|Placebo plus sitagliptin alone or in combination with metformin
268077|NCT00984867|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
268078|NCT00984867|P1|Participant Flow|Placebo|Placebo plus sitagliptin alone or in combination with metformin
268079|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268080|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
268081|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268082|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
268083|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268084|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
268085|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268086|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
268087|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268088|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
268089|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
268090|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
280023|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
268096|NCT00984815|P1|Participant Flow|HZT-501|Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
268097|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
268098|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
268099|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
268100|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
268101|NCT00984815|E1|Reported Event|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
268102|NCT00984698|B3|Baseline|Total|Total of all reporting groups
268103|NCT00984698|B2|Baseline|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
268104|NCT00984698|B1|Baseline|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
268105|NCT00984698|P2|Participant Flow|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
268106|NCT00984698|P1|Participant Flow|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
268107|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
268108|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
268109|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
268110|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
268111|NCT00984698|E2|Reported Event|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
268112|NCT00984698|E1|Reported Event|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
268113|NCT00984659|B5|Baseline|Total|Total of all reporting groups
268114|NCT00984659|B4|Baseline|Albuterol and/or Ipratropium: Run-in Failure|Participants who entered the 2-week Run-in Period, during which they were permitted to use albuterol and/or ipratropium as rescue medication, but then failed to be randomized, or were randomized but did not receive a dose of study medication
268115|NCT00984659|B3|Baseline|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID
268116|NCT00984659|B2|Baseline|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
268117|NCT00984659|B1|Baseline|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
268118|NCT00984659|P4|Participant Flow|FSC 250/50 mcg: Double-blind Treatment Period|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
268243|NCT00984334|E3|Reported Event|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
268119|NCT00984659|P3|Participant Flow|SAL 50 mcg: Double-blind Treatment Period|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
268120|NCT00984659|P2|Participant Flow|Placebo: Double-blind Treatment Period|Matching placebo via DISKUS, administered as one inhalation twice daily (BID) during the 6-week Double-blind Treatment Period
268121|NCT00984659|P1|Participant Flow|Albuterol and/or Ipratropium: Run-in Period|Participants were permitted to use albuterol and/or ipratropium as rescue medication during the 2-week Run-in Period
268122|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268123|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268124|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268125|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268126|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268127|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268128|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268129|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268130|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268131|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268132|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268133|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
268134|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268135|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268136|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268137|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268138|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268139|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268140|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268141|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
268142|NCT00984659|E3|Reported Event|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
268143|NCT00984659|E2|Reported Event|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
268144|NCT00984659|E1|Reported Event|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
268145|NCT00984620|B3|Baseline|Total|Total of all reporting groups
268146|NCT00984620|B2|Baseline|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268147|NCT00984620|B1|Baseline|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268202|NCT00984568|B2|Baseline|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
268148|NCT00984620|P2|Participant Flow|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268149|NCT00984620|P1|Participant Flow|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268150|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268151|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268152|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268153|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268154|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268155|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268156|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268157|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268158|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268159|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268160|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268203|NCT00984568|B1|Baseline|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
268244|NCT00984334|E2|Reported Event|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
268161|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268162|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268163|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268164|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268165|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268166|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268167|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268168|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268169|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268170|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268171|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268172|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268173|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268204|NCT00984568|P2|Participant Flow|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
268174|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268175|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268176|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268177|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268178|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268179|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268180|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268181|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
268182|NCT00984620|E2|Reported Event|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
268183|NCT00984620|E1|Reported Event|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.
268184|NCT00984594|B3|Baseline|Total|Total of all reporting groups
268185|NCT00984594|B2|Baseline|Primary|CR Plug will be placed in the site of the primary injury
268186|NCT00984594|B1|Baseline|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
268187|NCT00984594|P2|Participant Flow|Primary|CR Plug will be placed in the site of the primary injury.
268188|NCT00984594|P1|Participant Flow|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
268189|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
268190|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
268191|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
268192|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
268193|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
268194|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
268195|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
268196|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
268197|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury
268198|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
268199|NCT00984594|E2|Reported Event|Primary|Autograft will be placed in primary defect site.
268200|NCT00984594|E1|Reported Event|Backfill|CR-Plug will be placed in harvest site.
268201|NCT00984568|B3|Baseline|Total|Total of all reporting groups
280024|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
268205|NCT00984568|P1|Participant Flow|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
268206|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
268207|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
268208|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
268209|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
268210|NCT00984568|E2|Reported Event|Step-Up|"Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2~g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter."
268211|NCT00984568|E1|Reported Event|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
268212|NCT00984542|B1|Baseline|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268213|NCT00984542|P1|Participant Flow|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268214|NCT00984542|O1|Outcome|Bendatmustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268215|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268216|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268217|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268218|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268219|NCT00984542|E1|Reported Event|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
268220|NCT00984490|B1|Baseline|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
268221|NCT00984490|P1|Participant Flow|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
268222|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
268223|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
268224|NCT00984490|E1|Reported Event|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
268225|NCT00984334|B6|Baseline|Total|Total of all reporting groups
268226|NCT00984334|B5|Baseline|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
268227|NCT00984334|B4|Baseline|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
268228|NCT00984334|B3|Baseline|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
268229|NCT00984334|B2|Baseline|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
268230|NCT00984334|B1|Baseline|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
268231|NCT00984334|P5|Participant Flow|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
268232|NCT00984334|P4|Participant Flow|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
268233|NCT00984334|P3|Participant Flow|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
268234|NCT00984334|P2|Participant Flow|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
268235|NCT00984334|P1|Participant Flow|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
268236|NCT00984334|O5|Outcome|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
268237|NCT00984334|O4|Outcome|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
268238|NCT00984334|O3|Outcome|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
268239|NCT00984334|O2|Outcome|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
268240|NCT00984334|O1|Outcome|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
268241|NCT00984334|E5|Reported Event|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
268245|NCT00984334|E1|Reported Event|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
268246|NCT00984308|B3|Baseline|Total|Total of all reporting groups
268247|NCT00984308|B2|Baseline|Control|
268248|NCT00984308|B1|Baseline|Intervention|
268249|NCT00984308|P2|Participant Flow|Control|The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
268250|NCT00984308|P1|Participant Flow|Intervention|The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
268251|NCT00984308|O2|Outcome|Control|
268252|NCT00984308|O1|Outcome|Intervention|
268253|NCT00984308|O2|Outcome|Control|
268254|NCT00984308|O1|Outcome|Intervention|
268255|NCT00984308|O2|Outcome|Control|
268256|NCT00984308|O1|Outcome|Intervention|
268257|NCT00984308|E2|Reported Event|Control|
268258|NCT00984308|E1|Reported Event|Intervention|
268259|NCT00984295|B4|Baseline|Total|Total of all reporting groups
268260|NCT00984295|B3|Baseline|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268261|NCT00984295|B2|Baseline|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268262|NCT00984295|B1|Baseline|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268263|NCT00984295|P3|Participant Flow|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268264|NCT00984295|P2|Participant Flow|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268265|NCT00984295|P1|Participant Flow|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268266|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268267|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268268|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268269|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268270|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268271|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268272|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268273|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268274|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268275|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268276|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268277|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268278|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268279|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268280|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268281|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268282|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268283|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268284|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268285|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268286|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268287|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268288|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268289|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268290|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268291|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268292|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268293|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268294|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268295|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268296|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268297|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268298|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268299|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268300|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268301|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268302|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268303|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268304|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268305|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268306|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268307|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268308|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268309|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268310|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268311|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268312|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268313|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268314|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268339|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
270393|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
268315|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268316|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268317|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268318|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268319|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268320|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268321|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268322|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268323|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268324|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268325|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268326|NCT00984295|E3|Reported Event|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268327|NCT00984295|E2|Reported Event|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
268328|NCT00984295|E1|Reported Event|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
268329|NCT00984282|B3|Baseline|Total|Total of all reporting groups
268330|NCT00984282|B2|Baseline|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
268331|NCT00984282|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
268332|NCT00984282|P2|Participant Flow|DB Placebo First, Then Option of OL Sorafenib Treatment|Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.
268333|NCT00984282|P1|Participant Flow|DB Sorafenib First, Then Option of OL Sorafenib Treatment|Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
268334|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268335|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268336|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268337|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268338|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268340|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268341|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268342|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268343|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268344|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268345|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268346|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268347|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
268348|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
268349|NCT00984282|E4|Reported Event|Placebo, Open Label Only (Switch to Sorafenib)|Reporting Group 4: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug 2012
268350|NCT00984282|E3|Reported Event|Sorafenib, Open Label Only (Sorafenib Continued)|Reporting Group 3: Participants on sorafenib who continued OL sorafenib treatment, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug 2012.
268351|NCT00984282|E2|Reported Event|Placebo (Double Blind Only)|Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
268352|NCT00984282|E1|Reported Event|Sorafenib (Double Blind Only)|Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period
268353|NCT00984256|B3|Baseline|Total|Total of all reporting groups
268354|NCT00984256|B2|Baseline|Control|The six (6) Control volunteers were enrolled in a open label arm and received no treatment prior to malaria challenge.
268355|NCT00984256|B1|Baseline|Malarone|"Thirty (30) subjects were placed in the Malarone (treatment) Arm. The thirty subjects were then randomized into 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. The groups received treatment as follows:~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
268356|NCT00984256|P2|Participant Flow|Malarone Treatment|"Within the Malarone Arm, thirty volunteers were randomized into the below 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
268357|NCT00984256|P1|Participant Flow|Control|The six volunteers in control cohort were enrolled as infectivity controls and did not undergo randomization or receive any study drug.
268358|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
268359|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
268360|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
268361|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
268362|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
268363|NCT00984256|O5|Outcome|Prophylaxis Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
268364|NCT00984256|O4|Outcome|Prophylaxis Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
268365|NCT00984256|O3|Outcome|Prophylaxis Group 3|(Group 3)Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
268366|NCT00984256|O2|Outcome|Prophylaxis Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
268367|NCT00984256|O1|Outcome|Prophylaxis Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
268368|NCT00984256|O6|Outcome|Control|Six volunteers for the control cohort were enrolled as an infectivity control and did not undergo drug dosing.
268369|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
268370|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
268371|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
268372|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
268373|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
268374|NCT00984256|E2|Reported Event|Control|no malarone prophylaxis received
268412|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268662|NCT00983489|O2|Outcome|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
268375|NCT00984256|E1|Reported Event|Drug|"Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2)~5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
268376|NCT00984204|B1|Baseline|Treatment Arm|
268377|NCT00984204|P1|Participant Flow|Treatment Arm|
268378|NCT00984204|O1|Outcome|Treatment Arm|
268379|NCT00984204|O1|Outcome|Treatment Arm|
268380|NCT00984204|O1|Outcome|Treatment Arm|
268381|NCT00984204|E1|Reported Event|Treatment Arm|
268382|NCT00984165|B5|Baseline|Total|Total of all reporting groups
268383|NCT00984165|B4|Baseline|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
268384|NCT00984165|B3|Baseline|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
268385|NCT00984165|B2|Baseline|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
268386|NCT00984165|B1|Baseline|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
268387|NCT00984165|P4|Participant Flow|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
268388|NCT00984165|P3|Participant Flow|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
268389|NCT00984165|P2|Participant Flow|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
268390|NCT00984165|P1|Participant Flow|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
268391|NCT00984165|O4|Outcome|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
268392|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
268393|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
268394|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
268395|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion-Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
268396|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
268397|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
268398|NCT00984165|E4|Reported Event|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
268399|NCT00984165|E3|Reported Event|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
268400|NCT00984165|E2|Reported Event|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
268401|NCT00984165|E1|Reported Event|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
268402|NCT00984139|B1|Baseline|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268403|NCT00984139|P1|Participant Flow|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268404|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268405|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268406|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268407|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268408|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268409|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268410|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268411|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268663|NCT00983489|O1|Outcome|Counselling|counselling: Breast feeding counselling will be done to mothers
268413|NCT00984139|E1|Reported Event|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
268414|NCT00984061|B1|Baseline|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
268415|NCT00984061|P1|Participant Flow|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
268416|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
268417|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
268418|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
268419|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
268420|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
268421|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
268422|NCT00984061|E3|Reported Event|Colchicine With Clarithromycin|On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
268423|NCT00984061|E2|Reported Event|Clarithromycin Alone|On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals.
268424|NCT00984061|E1|Reported Event|Colchicine Alone|On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
268425|NCT00984022|B3|Baseline|Total|Total of all reporting groups
268426|NCT00984022|B2|Baseline|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268427|NCT00984022|B1|Baseline|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268428|NCT00984022|P2|Participant Flow|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268429|NCT00984022|P1|Participant Flow|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268430|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268431|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268432|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268433|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268434|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268435|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268436|NCT00984022|E2|Reported Event|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
268437|NCT00984022|E1|Reported Event|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
268438|NCT00984009|B1|Baseline|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268664|NCT00983489|E3|Reported Event|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
268439|NCT00984009|P1|Participant Flow|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268440|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268441|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268442|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268443|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268444|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268445|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268446|NCT00984009|E3|Reported Event|Colchicine With Grapefruit Juice|On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
268447|NCT00984009|E2|Reported Event|Grapefruit Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
268448|NCT00984009|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268449|NCT00983983|B4|Baseline|Total|Total of all reporting groups
268450|NCT00983983|B3|Baseline|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268451|NCT00983983|B2|Baseline|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268452|NCT00983983|B1|Baseline|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268453|NCT00983983|P3|Participant Flow|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268454|NCT00983983|P2|Participant Flow|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268455|NCT00983983|P1|Participant Flow|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268456|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268457|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268458|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268459|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268460|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268461|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268462|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268463|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268464|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268465|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268466|NCT00983983|O2|Outcome|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268467|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268468|NCT00983983|E3|Reported Event|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268469|NCT00983983|E2|Reported Event|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268470|NCT00983983|E1|Reported Event|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
268471|NCT00983957|B1|Baseline|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268472|NCT00983957|P1|Participant Flow|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268473|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268474|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268475|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268476|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268477|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268478|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268479|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268480|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268597|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268481|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268482|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268483|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268484|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268485|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268486|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268487|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268488|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268489|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268490|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268491|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268492|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268493|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268494|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268495|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268496|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268497|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268498|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
268499|NCT00983957|E6|Reported Event|Ortho Tri-Cyclen + Daclatasvir Days 68-77|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
268500|NCT00983957|E5|Reported Event|Ortho Tri-Cyclen Days 57-67|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
268501|NCT00983957|E4|Reported Event|Ortho Tri-Cyclen Days 47-56|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
268502|NCT00983957|E3|Reported Event|Ortho Tri-Cyclen Days 29-46|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
268503|NCT00983957|E2|Reported Event|Ortho Tri-Cyclen Days 1-28|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
268504|NCT00983957|E1|Reported Event|All Treated Participants|Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
268505|NCT00983931|B1|Baseline|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268506|NCT00983931|P1|Participant Flow|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268507|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268508|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268509|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268510|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268511|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268512|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268513|NCT00983931|E2|Reported Event|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268514|NCT00983931|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268515|NCT00983918|B5|Baseline|Total|Total of all reporting groups
268516|NCT00983918|B4|Baseline|Propofol|General Anesthesia with Propofol
268517|NCT00983918|B3|Baseline|Isoflurane|General Anesthesia with Isoflurane
268518|NCT00983918|B2|Baseline|Sevoflurane|General Anesthesia with Sevoflurane
268519|NCT00983918|B1|Baseline|Desflurane|General Anesthesia with Desflurane
268520|NCT00983918|P4|Participant Flow|Propofol|General Anesthesia with Propofol
268521|NCT00983918|P3|Participant Flow|Isoflurane|General Anesthesia with Isoflurane
268522|NCT00983918|P2|Participant Flow|Sevoflurane|General Anesthesia with Sevoflurane
268523|NCT00983918|P1|Participant Flow|Desflurane|General Anesthesia with Desflurane
268524|NCT00983918|O4|Outcome|Propofol|General Anesthesia with Propofol
268525|NCT00983918|O3|Outcome|Isoflurane|General Anesthesia with Isoflurane
268526|NCT00983918|O2|Outcome|Sevoflurane|General Anesthesia with Sevoflurane
268527|NCT00983918|O1|Outcome|Desflurane|General Anesthesia with Desflurane
268528|NCT00983918|E4|Reported Event|Propofol|General Anesthesia with Propofol
268529|NCT00983918|E3|Reported Event|Isoflurane|General Anesthesia with Isoflurane
268530|NCT00983918|E2|Reported Event|Sevoflurane|General Anesthesia with Sevoflurane
268531|NCT00983918|E1|Reported Event|Desflurane|General Anesthesia with Desflurane
268532|NCT00983905|B1|Baseline|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268533|NCT00983905|P1|Participant Flow|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268534|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268535|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
268536|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268537|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
268538|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268539|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
268540|NCT00983905|E3|Reported Event|Theophylline With Steady-state Colchicine|On Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45 am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
268541|NCT00983905|E2|Reported Event|Colchicine Alone|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals.
268542|NCT00983905|E1|Reported Event|Theophylline Alone|Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
268543|NCT00983892|B3|Baseline|Total|Total of all reporting groups
268544|NCT00983892|B2|Baseline|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
268545|NCT00983892|B1|Baseline|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
268546|NCT00983892|P2|Participant Flow|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
268547|NCT00983892|P1|Participant Flow|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
268548|NCT00983892|O2|Outcome|Control|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
268549|NCT00983892|O1|Outcome|CarePartners Intervention +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
268550|NCT00983892|E2|Reported Event|CarePartners-|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
268551|NCT00983892|E1|Reported Event|CarePartners+|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
268552|NCT00983853|B7|Baseline|Total|Total of all reporting groups
268553|NCT00983853|B6|Baseline|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268554|NCT00983853|B5|Baseline|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268555|NCT00983853|B4|Baseline|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268556|NCT00983853|B3|Baseline|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268557|NCT00983853|B2|Baseline|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268558|NCT00983853|B1|Baseline|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268559|NCT00983853|P6|Participant Flow|Part B: ATV/R-based HAART + Pbo/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268560|NCT00983853|P5|Participant Flow|Part B: ATV/R-based HAART + T/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268561|NCT00983853|P4|Participant Flow|Part B: EFV-based HAART + Pbo/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268562|NCT00983853|P3|Participant Flow|Part B: EFV-based HAART + T/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268563|NCT00983853|P2|Participant Flow|Part A: Pbo/PR|"Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268564|NCT00983853|P1|Participant Flow|Part A: T/PR|"Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
268565|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268598|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268566|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268567|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268568|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
268569|NCT00983853|O2|Outcome|ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)|
268570|NCT00983853|O1|Outcome|EFV-based (Test, N=15) vs No HAART (Reference, N=7)|
268571|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268572|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268573|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268574|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268575|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268576|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268577|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268578|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268579|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268580|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268581|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268582|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268583|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268584|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268585|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268586|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
268587|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268588|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
268589|NCT00983853|E2|Reported Event|Total PR|Pooled PR from Part A and Part B
268590|NCT00983853|E1|Reported Event|T/PR|Pooled T/PR from Part A and Part B
268591|NCT00983827|B1|Baseline|Aquatic Treadmill Training|
268592|NCT00983827|P1|Participant Flow|Aquatic Treadmill Training|Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
268593|NCT00983827|O1|Outcome|Aquatic Treadmill Training|
268594|NCT00983827|E1|Reported Event|Aquatic Treadmill Training|
268595|NCT00983801|B1|Baseline|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268596|NCT00983801|P1|Participant Flow|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268599|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268600|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268601|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268602|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268603|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268604|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268605|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268606|NCT00983801|E1|Reported Event|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
268607|NCT00983749|B3|Baseline|Total|Total of all reporting groups
268608|NCT00983749|B2|Baseline|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
268609|NCT00983749|B1|Baseline|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
268610|NCT00983749|P2|Participant Flow|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
268611|NCT00983749|P1|Participant Flow|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
268612|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
268613|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
268614|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
268615|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
268616|NCT00983749|E2|Reported Event|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
268617|NCT00983749|E1|Reported Event|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
268618|NCT00983645|B3|Baseline|Total|Total of all reporting groups
268619|NCT00983645|B2|Baseline|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268620|NCT00983645|B1|Baseline|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268621|NCT00983645|P2|Participant Flow|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268622|NCT00983645|P1|Participant Flow|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268623|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268624|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268625|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268626|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268627|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268628|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268629|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
268630|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268631|NCT00983645|E2|Reported Event|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
270394|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
268632|NCT00983645|E1|Reported Event|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
268633|NCT00983541|B1|Baseline|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
268634|NCT00983541|P1|Participant Flow|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
268635|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268636|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268637|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268638|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268639|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268640|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268641|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268642|NCT00983541|E1|Reported Event|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
268643|NCT00983515|B1|Baseline|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268644|NCT00983515|P1|Participant Flow|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268645|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268646|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268647|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268648|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268649|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268650|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268651|NCT00983515|E3|Reported Event|Colchicine With Steady-state Ritonavir|On Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
268652|NCT00983515|E2|Reported Event|Ritonavir Alone|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals.
268653|NCT00983515|E1|Reported Event|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268654|NCT00983489|B4|Baseline|Total|Total of all reporting groups
268655|NCT00983489|B3|Baseline|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
268656|NCT00983489|B2|Baseline|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
268657|NCT00983489|B1|Baseline|Counselling|counselling: Breast feeding counselling will be done to mothers
268658|NCT00983489|P3|Participant Flow|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
268659|NCT00983489|P2|Participant Flow|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
268665|NCT00983489|E2|Reported Event|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
268666|NCT00983489|E1|Reported Event|Counselling|counselling: Breast feeding counselling will be done to mothers
268667|NCT00983476|B4|Baseline|Total|Total of all reporting groups
268668|NCT00983476|B3|Baseline|Arm 3|usual care + educational handouts regarding weight loss
268669|NCT00983476|B2|Baseline|Arm 2|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268670|NCT00983476|B1|Baseline|Arm 1|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268671|NCT00983476|P3|Participant Flow|Arm 3|usual care + educational handouts regarding weight loss
268672|NCT00983476|P2|Participant Flow|Arm 2|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
268673|NCT00983476|P1|Participant Flow|Arm 1|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
268674|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268675|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268676|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268677|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268678|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268679|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
268680|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268681|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268682|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268683|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268684|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268685|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268686|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268687|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268688|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268689|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268690|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268691|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268692|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268693|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268694|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268695|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268696|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
268697|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
268698|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
268699|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
270395|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
268700|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
268701|NCT00983476|E3|Reported Event|Arm 3|usual care + educational handouts regarding weight loss
268702|NCT00983476|E2|Reported Event|Arm 2|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
268703|NCT00983476|E1|Reported Event|Arm 1|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
268704|NCT00983437|B1|Baseline|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268705|NCT00983437|P1|Participant Flow|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268706|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268707|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268708|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268709|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268710|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268711|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268712|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268713|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268714|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268715|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268716|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268717|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268718|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268719|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268720|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268721|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268722|NCT00983437|E1|Reported Event|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
268723|NCT00983385|B1|Baseline|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268724|NCT00983385|P1|Participant Flow|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268725|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
268726|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
268727|NCT00983385|O1|Outcome|Tapentadol|Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
268788|NCT00983346|P1|Participant Flow|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
269098|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
268728|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
268729|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
268730|NCT00983385|O1|Outcome|Tapentadol|"Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
268731|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268732|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268733|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268734|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268735|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268736|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268737|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269060|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
268738|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268739|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268740|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268741|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268742|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268743|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268744|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268745|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268746|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268747|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268748|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268749|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268750|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268751|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268752|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268753|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
268754|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
268755|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
268756|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
268757|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
268758|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
268759|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
268760|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
268761|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
268762|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268763|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268764|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268765|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268789|NCT00983346|O1|Outcome|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
268766|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268767|NCT00983385|E1|Reported Event|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268768|NCT00983372|B1|Baseline|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268769|NCT00983372|P1|Participant Flow|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268770|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268771|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268772|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268773|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268774|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268775|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268776|NCT00983372|E3|Reported Event|Colchicine With Steady-state Diltiazem|On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
268777|NCT00983372|E2|Reported Event|Diltiazem Alone|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m.
268778|NCT00983372|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
268779|NCT00983359|B1|Baseline|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268780|NCT00983359|P1|Participant Flow|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268781|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268782|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268783|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268784|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268785|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268786|NCT00983359|E1|Reported Event|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
268787|NCT00983346|B1|Baseline|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
268816|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
269094|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
268790|NCT00983346|E1|Reported Event|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
268791|NCT00983294|B1|Baseline|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
268792|NCT00983294|P1|Participant Flow|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
268793|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
268794|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
268795|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
268796|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
268797|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
268798|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
268799|NCT00983294|E3|Reported Event|Colchicine With Steady-state Azithromycin|On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
268800|NCT00983294|E2|Reported Event|Azithromycin Alone|On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
268801|NCT00983294|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
268802|NCT00983281|B3|Baseline|Total|Total of all reporting groups
268803|NCT00983281|B2|Baseline|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
268804|NCT00983281|B1|Baseline|Hextend|Patients that received Hextend as part of their resuscitation fluid.
268805|NCT00983281|P2|Participant Flow|Standard of Care|Patients that received crystalloid but no Hextend as part of their resuscitation.
268806|NCT00983281|P1|Participant Flow|Hextend|Patients that received Hextend as part of their resuscitation fluid.
268807|NCT00983281|O2|Outcome|Standard of Care|PAtients that did not receive Hextend as part of their resuscitation fluid.
268808|NCT00983281|O1|Outcome|Hextend|Patients that received Hextend as part of their resuscitation fluid.
268809|NCT00983281|E2|Reported Event|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
268810|NCT00983281|E1|Reported Event|Hextend|Patients that received Hextend as part of their resuscitation fluid.
268811|NCT00983242|B1|Baseline|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
268812|NCT00983242|P1|Participant Flow|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
268813|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
268814|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
268815|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
268817|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
268818|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
268819|NCT00983242|E3|Reported Event|Colchicine With Verapamil HCl ER|At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
268820|NCT00983242|E2|Reported Event|Verapamil HCl ER|At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
268821|NCT00983242|E1|Reported Event|Colchicine Alone|At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
268822|NCT00983216|B1|Baseline|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268823|NCT00983216|P1|Participant Flow|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268824|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268825|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268826|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268827|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268828|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268829|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268830|NCT00983216|E3|Reported Event|Colchicine With Ketoconazole (at Steady-state)|On the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
268831|NCT00983216|E2|Reported Event|Ketoconazole Alone|On Day 15 to 18, subjects took ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals.
268832|NCT00983216|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
268833|NCT00983073|B1|Baseline|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268834|NCT00983073|P1|Participant Flow|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268835|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268881|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268836|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268837|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268838|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268839|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268840|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268841|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268842|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268843|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268844|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268845|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268846|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268847|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268848|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268849|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268850|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268851|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268852|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268853|NCT00983073|E1|Reported Event|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
268854|NCT00982995|B1|Baseline|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
268855|NCT00982995|P1|Participant Flow|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
268856|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
268857|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
270396|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
268858|NCT00982995|E1|Reported Event|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
268859|NCT00982735|B1|Baseline|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268860|NCT00982735|P1|Participant Flow|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268861|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268862|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268863|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268864|NCT00982735|E1|Reported Event|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
268865|NCT00982657|B5|Baseline|Total|Total of all reporting groups
268866|NCT00982657|B4|Baseline|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268867|NCT00982657|B3|Baseline|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268868|NCT00982657|B2|Baseline|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268869|NCT00982657|B1|Baseline|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268870|NCT00982657|P4|Participant Flow|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268871|NCT00982657|P3|Participant Flow|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268872|NCT00982657|P2|Participant Flow|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268873|NCT00982657|P1|Participant Flow|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268874|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268875|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268876|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268877|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268878|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268879|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268880|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268949|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268882|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268883|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268884|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268885|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268886|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268887|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268888|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.
268889|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268890|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
268891|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
268892|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
268893|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268894|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268895|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268896|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268897|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268898|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268899|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268900|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268901|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
269095|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
270397|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
268902|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268903|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268904|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268905|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268906|NCT00982657|O1|Outcome|All Participants|All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268907|NCT00982657|E4|Reported Event|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268908|NCT00982657|E3|Reported Event|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268909|NCT00982657|E2|Reported Event|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268910|NCT00982657|E1|Reported Event|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
268911|NCT00982644|B3|Baseline|Total|Total of all reporting groups
268912|NCT00982644|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268913|NCT00982644|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268914|NCT00982644|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268915|NCT00982644|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268916|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268917|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268918|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268919|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268920|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268921|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268922|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268923|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268924|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
280025|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
268925|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268926|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268927|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268928|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268929|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268930|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268931|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268932|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268933|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268934|NCT00982644|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268935|NCT00982644|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
268936|NCT00982592|B3|Baseline|Total|Total of all reporting groups
268937|NCT00982592|B2|Baseline|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268938|NCT00982592|B1|Baseline|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268939|NCT00982592|P2|Participant Flow|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268940|NCT00982592|P1|Participant Flow|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268941|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268942|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268943|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268944|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268945|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268946|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268947|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268948|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268950|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268951|NCT00982592|E2|Reported Event|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268952|NCT00982592|E1|Reported Event|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
268953|NCT00982553|B1|Baseline|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
268954|NCT00982553|P1|Participant Flow|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
268955|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
268956|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
268957|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
268958|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
268959|NCT00982553|E1|Reported Event|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
268960|NCT00982488|B6|Baseline|Total|Total of all reporting groups
268961|NCT00982488|B5|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268962|NCT00982488|B4|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268963|NCT00982488|B3|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268964|NCT00982488|B2|Baseline|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268965|NCT00982488|B1|Baseline|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268966|NCT00982488|P5|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268979|NCT00982488|E2|Reported Event|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268967|NCT00982488|P4|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268968|NCT00982488|P3|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268969|NCT00982488|P2|Participant Flow|Imatinib, 400 mg BID, Chronic Phase|Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268970|NCT00982488|P1|Participant Flow|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268971|NCT00982488|O5|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268972|NCT00982488|O4|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268973|NCT00982488|O3|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268974|NCT00982488|O2|Outcome|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268975|NCT00982488|O1|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268976|NCT00982488|E5|Reported Event|Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268977|NCT00982488|E4|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268978|NCT00982488|E3|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
269099|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
268980|NCT00982488|E1|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
268981|NCT00982423|B3|Baseline|Total|Total of all reporting groups
268982|NCT00982423|B2|Baseline|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268983|NCT00982423|B1|Baseline|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
268984|NCT00982423|P2|Participant Flow|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268985|NCT00982423|P1|Participant Flow|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
268986|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268987|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
268988|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268989|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
268990|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268991|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
268992|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268993|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
268994|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268995|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
268996|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268997|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
268998|NCT00982423|E2|Reported Event|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
268999|NCT00982423|E1|Reported Event|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
269000|NCT00982410|B3|Baseline|Total|Total of all reporting groups
269001|NCT00982410|B2|Baseline|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269002|NCT00982410|B1|Baseline|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269003|NCT00982410|P2|Participant Flow|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269004|NCT00982410|P1|Participant Flow|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269005|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269006|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
270398|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
269007|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269008|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269009|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269010|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269011|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269012|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269013|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269014|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269015|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269016|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269017|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269018|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269019|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269020|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269021|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269022|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269023|NCT00982410|E2|Reported Event|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
269024|NCT00982410|E1|Reported Event|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
269025|NCT00982345|B1|Baseline|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
269026|NCT00982345|P1|Participant Flow|Seroquel XR|Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
269027|NCT00982345|O1|Outcome|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
269028|NCT00982345|E1|Reported Event|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
269029|NCT00982280|B1|Baseline|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269030|NCT00982280|P1|Participant Flow|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269031|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269032|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269033|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269058|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269034|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269035|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269036|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269037|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269038|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269039|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269040|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269041|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269042|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269043|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269059|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
280026|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
269044|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269045|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269046|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269047|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269048|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269049|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269050|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269051|NCT00982280|E1|Reported Event|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
269052|NCT00982228|B3|Baseline|Total|Total of all reporting groups
269053|NCT00982228|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269054|NCT00982228|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269055|NCT00982228|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269056|NCT00982228|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269057|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269096|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269061|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269062|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269063|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269064|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269065|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269066|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269067|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269068|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269069|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269070|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269071|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269072|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269073|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269074|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269075|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269076|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269077|NCT00982228|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
269078|NCT00982228|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
269079|NCT00982189|B5|Baseline|Total|Total of all reporting groups
269080|NCT00982189|B4|Baseline|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269081|NCT00982189|B3|Baseline|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
269082|NCT00982189|B2|Baseline|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
269083|NCT00982189|B1|Baseline|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
269084|NCT00982189|P4|Participant Flow|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269085|NCT00982189|P3|Participant Flow|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
269086|NCT00982189|P2|Participant Flow|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
269087|NCT00982189|P1|Participant Flow|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
269088|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269089|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
269090|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
269091|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
269092|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269093|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
280027|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
269100|NCT00982189|E4|Reported Event|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
269101|NCT00982189|E3|Reported Event|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
269102|NCT00982189|E2|Reported Event|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
269103|NCT00982189|E1|Reported Event|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
269104|NCT00982137|B5|Baseline|Total|Total of all reporting groups
269105|NCT00982137|B4|Baseline|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269106|NCT00982137|B3|Baseline|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269107|NCT00982137|B2|Baseline|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269108|NCT00982137|B1|Baseline|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269109|NCT00982137|P4|Participant Flow|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269110|NCT00982137|P3|Participant Flow|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269111|NCT00982137|P2|Participant Flow|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269112|NCT00982137|P1|Participant Flow|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269113|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269114|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269115|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269116|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269117|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
269118|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
269119|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
269120|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
269121|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269122|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269123|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269124|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269125|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269126|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269127|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269128|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269129|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
269130|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
269131|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
269132|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
269133|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL|Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
269134|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
269135|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
269136|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
269137|NCT00982137|E4|Reported Event|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
269138|NCT00982137|E3|Reported Event|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
269139|NCT00982137|E2|Reported Event|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
269140|NCT00982137|E1|Reported Event|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
269141|NCT00982111|B3|Baseline|Total|Total of all reporting groups
269142|NCT00982111|B2|Baseline|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269143|NCT00982111|B1|Baseline|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269144|NCT00982111|P2|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
269145|NCT00982111|P1|Participant Flow|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.~Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
269146|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269147|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269148|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269149|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269150|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269151|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269152|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269153|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269154|NCT00982111|O1|Outcome|Necitumumab + Pemextrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269155|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269156|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269157|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269158|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269214|NCT00981825|E1|Reported Event|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
269366|NCT00981227|E3|Reported Event|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269159|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269160|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269161|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269162|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269163|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269164|NCT00982111|E2|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269165|NCT00982111|E1|Reported Event|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
269166|NCT00982020|B3|Baseline|Total|Total of all reporting groups
269167|NCT00982020|B2|Baseline|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
269168|NCT00982020|B1|Baseline|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
269169|NCT00982020|P2|Participant Flow|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269170|NCT00982020|P1|Participant Flow|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269171|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269172|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269173|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269174|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269175|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269176|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269177|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269178|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269179|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
269180|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
269181|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
269182|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
269183|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269184|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269185|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
269186|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
269187|NCT00982020|E2|Reported Event|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
269188|NCT00982020|E1|Reported Event|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
269189|NCT00982007|B5|Baseline|Total|Total of all reporting groups
269190|NCT00982007|B4|Baseline|Cohort 2 (Group D) - IV Iron (Standard of Care)|Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
269191|NCT00982007|B3|Baseline|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269192|NCT00982007|B2|Baseline|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
269193|NCT00982007|B1|Baseline|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269194|NCT00982007|P4|Participant Flow|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
269195|NCT00982007|P3|Participant Flow|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269196|NCT00982007|P2|Participant Flow|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
269197|NCT00982007|P1|Participant Flow|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269198|NCT00982007|O4|Outcome|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
269199|NCT00982007|O3|Outcome|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269200|NCT00982007|O2|Outcome|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
269201|NCT00982007|O1|Outcome|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269202|NCT00982007|E4|Reported Event|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
269203|NCT00982007|E3|Reported Event|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269204|NCT00982007|E2|Reported Event|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
269205|NCT00982007|E1|Reported Event|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
269206|NCT00981825|B3|Baseline|Total|Total of all reporting groups
269207|NCT00981825|B2|Baseline|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)
269208|NCT00981825|B1|Baseline|Fluoride 1st, Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)
269209|NCT00981825|P2|Participant Flow|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
269210|NCT00981825|P1|Participant Flow|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
269211|NCT00981825|O2|Outcome|Triclosan/Fluoride Toothpaste|Triclosan/Fluoride toothpaste (experimental)
269212|NCT00981825|O1|Outcome|Fluoride Toothpaste (Control)|Fluoride toothpaste (control)
269213|NCT00981825|E2|Reported Event|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
269215|NCT00981812|B1|Baseline|Primary|Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
269216|NCT00981812|P1|Participant Flow|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
269217|NCT00981812|O1|Outcome|Lesions Visualized Using Positron Emission Mammography (PEM)|Total lesions visualized using positron emission mammography.
269218|NCT00981812|E1|Reported Event|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
269219|NCT00981669|B3|Baseline|Total|Total of all reporting groups
269220|NCT00981669|B2|Baseline|Placebo|3 doses with 6 weeks interval
269221|NCT00981669|B1|Baseline|Rotavirus Vaccine|3 doses with 6 weeks interval
269222|NCT00981669|P2|Participant Flow|Placebo|3 doses with 6 weeks interval
269223|NCT00981669|P1|Participant Flow|Rotavirus Vaccine|3 doses with 6 weeks interval
269224|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
269225|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
269226|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
269227|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
269228|NCT00981669|E2|Reported Event|Placebo|3 doses with 6 weeks interval
269229|NCT00981669|E1|Reported Event|Rotavirus Vaccine|3 doses with 6 weeks interval
269230|NCT00981630|B5|Baseline|Total|Total of all reporting groups
269231|NCT00981630|B4|Baseline|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269232|NCT00981630|B3|Baseline|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269233|NCT00981630|B2|Baseline|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269234|NCT00981630|B1|Baseline|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269235|NCT00981630|P4|Participant Flow|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269236|NCT00981630|P3|Participant Flow|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269237|NCT00981630|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269238|NCT00981630|P1|Participant Flow|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269239|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269240|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269241|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269242|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269243|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269244|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269245|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269246|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269247|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269248|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269249|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269250|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269251|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269252|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269253|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269254|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269255|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269256|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269257|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269258|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269259|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269260|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269261|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269262|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269263|NCT00981630|E4|Reported Event|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
269264|NCT00981630|E3|Reported Event|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
269265|NCT00981630|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
269266|NCT00981630|E1|Reported Event|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
269267|NCT00981461|B3|Baseline|Total|Total of all reporting groups
269268|NCT00981461|B2|Baseline|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
269269|NCT00981461|B1|Baseline|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
269270|NCT00981461|P2|Participant Flow|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
269271|NCT00981461|P1|Participant Flow|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
269272|NCT00981461|O2|Outcome|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
269273|NCT00981461|O1|Outcome|Control Device|This control device is inactive emitting white light
269274|NCT00981461|E2|Reported Event|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
269275|NCT00981461|E1|Reported Event|Control Device|This control device is inactive emitting white light
269276|NCT00981409|B3|Baseline|Total|Total of all reporting groups
269277|NCT00981409|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269278|NCT00981409|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269279|NCT00981409|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269280|NCT00981409|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269281|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269282|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269283|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269284|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269285|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269286|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269287|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269288|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269289|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269290|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269291|NCT00981409|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
269292|NCT00981409|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
269293|NCT00981370|B1|Baseline|Group 1|First group of subjects to be enrolled.
269294|NCT00981370|P1|Participant Flow|Group One|No enrollment
269295|NCT00981370|O1|Outcome|Group 1|First group of subjects enrolled.
269296|NCT00981370|E1|Reported Event|Group 1|No patients enrolled
269297|NCT00981305|B3|Baseline|Total|Total of all reporting groups
269298|NCT00981305|B2|Baseline|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269299|NCT00981305|B1|Baseline|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269300|NCT00981305|P2|Participant Flow|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269301|NCT00981305|P1|Participant Flow|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269302|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269303|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269304|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269305|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269306|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269307|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269308|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269364|NCT00981227|E5|Reported Event|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269365|NCT00981227|E4|Reported Event|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
269309|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269310|NCT00981305|E2|Reported Event|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269311|NCT00981305|E1|Reported Event|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
269312|NCT00981292|B7|Baseline|Total|Total of all reporting groups
269313|NCT00981292|B6|Baseline|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269314|NCT00981292|B5|Baseline|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269315|NCT00981292|B4|Baseline|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269316|NCT00981292|B3|Baseline|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269317|NCT00981292|B2|Baseline|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269318|NCT00981292|B1|Baseline|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269319|NCT00981292|P6|Participant Flow|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269320|NCT00981292|P5|Participant Flow|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269321|NCT00981292|P4|Participant Flow|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269322|NCT00981292|P3|Participant Flow|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269323|NCT00981292|P2|Participant Flow|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269324|NCT00981292|P1|Participant Flow|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269325|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
269326|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
269327|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
269328|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
269329|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
269330|NCT00981292|O1|Outcome|135mg|All participants when consumed 135mg EGCG.
269331|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
269332|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
269333|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
269334|NCT00981292|E6|Reported Event|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269335|NCT00981292|E5|Reported Event|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
269336|NCT00981292|E4|Reported Event|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269337|NCT00981292|E3|Reported Event|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269338|NCT00981292|E2|Reported Event|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
269339|NCT00981292|E1|Reported Event|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
269340|NCT00981227|B7|Baseline|Total|Total of all reporting groups
269341|NCT00981227|B6|Baseline|Placebo|"placebo~Placebo : oral route"
269342|NCT00981227|B5|Baseline|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269343|NCT00981227|B4|Baseline|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
269344|NCT00981227|B3|Baseline|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269345|NCT00981227|B2|Baseline|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
269346|NCT00981227|B1|Baseline|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
269347|NCT00981227|P6|Participant Flow|Placebo|"placebo~Placebo : oral route"
269348|NCT00981227|P5|Participant Flow|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269349|NCT00981227|P4|Participant Flow|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
269350|NCT00981227|P3|Participant Flow|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
269351|NCT00981227|P2|Participant Flow|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
269352|NCT00981227|P1|Participant Flow|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
269353|NCT00981227|O4|Outcome|ESL 800 mg/Day|total daily dose;oral route
269354|NCT00981227|O3|Outcome|ESL 1600 mg/Day|total daily dose;oral route
269355|NCT00981227|O2|Outcome|ESL 1200 mg/Day|total daily dose;oral route
269356|NCT00981227|O1|Outcome|Placebo|"placebo~Placebo : oral route"
269357|NCT00981227|O6|Outcome|Placebo|total daily dose;oral route
269358|NCT00981227|O5|Outcome|ESL 800 mg Twice Daily|total daily dose;oral route
269359|NCT00981227|O4|Outcome|ESL 800 mg Once-daily|total daily dose;oral route
269360|NCT00981227|O3|Outcome|ESL 600 mg Twice Daily|total daily dose;oral route
269361|NCT00981227|O2|Outcome|ESL 400 mg Twice-daily|total daily dose;oral route
269362|NCT00981227|O1|Outcome|ESL 1200 mg Once Daily|total daily dose;oral route
269363|NCT00981227|E6|Reported Event|Placebo|"placebo~Placebo : oral route"
269367|NCT00981227|E2|Reported Event|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
269368|NCT00981227|E1|Reported Event|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
269369|NCT00981214|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269370|NCT00981214|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269371|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269372|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269373|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269374|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269375|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269376|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269377|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269378|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269379|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269380|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269381|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269382|NCT00981214|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
269383|NCT00981175|B4|Baseline|Total|Total of all reporting groups
269384|NCT00981175|B3|Baseline|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
269385|NCT00981175|B2|Baseline|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
269386|NCT00981175|B1|Baseline|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
269387|NCT00981175|P2|Participant Flow|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
269388|NCT00981175|P1|Participant Flow|ChimeriVax™-JE Vaccine First, Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
269389|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
269390|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
269391|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
269392|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
269393|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
269394|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
269395|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
269396|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
269397|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
269398|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
269399|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
269400|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
269401|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
269402|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
269403|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
269404|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
269405|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
269406|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
269407|NCT00981175|E3|Reported Event|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
269408|NCT00981175|E2|Reported Event|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
269409|NCT00981175|E1|Reported Event|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
269410|NCT00981084|B3|Baseline|Total|Total of all reporting groups
269411|NCT00981084|B2|Baseline|Placebo Then Armodafinil|
269412|NCT00981084|B1|Baseline|Armodafinil Then Placebo|"All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design~armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions."
269413|NCT00981084|P2|Participant Flow|Placebo First and Armodafinil Second|Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
269414|NCT00981084|P1|Participant Flow|Armodafinil First and Placebo Second|Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
269415|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269416|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269417|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269418|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269419|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269420|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269486|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269421|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269422|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
269423|NCT00981084|E4|Reported Event|Armodafinil Then Placebo (Placebo)|number of adverse events following placebo in the armodafniil then placebo condition.
269424|NCT00981084|E3|Reported Event|Placebo Then Armodafinil (Armodafinil)|Adverse events following armodafinil in the placebo/armodafinil group
269425|NCT00981084|E2|Reported Event|Armodafinil Then Placebo (Armodafinil)|Adverse events reported after taking armodafinil in the Armodafinil then placebo group
269426|NCT00981084|E1|Reported Event|Placebo Then Armodafinil (Placebo)|Adverse events reported after taking placebo in the Placebo then Armodafinil Group
269427|NCT00981058|B3|Baseline|Total|Total of all reporting groups
269428|NCT00981058|B2|Baseline|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269429|NCT00981058|B1|Baseline|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269430|NCT00981058|P2|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269431|NCT00981058|P1|Participant Flow|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269432|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269433|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269434|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269435|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269436|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269437|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269438|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269439|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269440|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269441|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269442|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269443|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269527|NCT00980746|E2|Reported Event|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269444|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269445|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269446|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269447|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269448|NCT00981058|E2|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269449|NCT00981058|E1|Reported Event|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
269450|NCT00981045|B3|Baseline|Total|Total of all reporting groups
269451|NCT00981045|B2|Baseline|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
269452|NCT00981045|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
269453|NCT00981045|P2|Participant Flow|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
269454|NCT00981045|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
269455|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
269456|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
269457|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
269458|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
269459|NCT00981045|E2|Reported Event|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
269460|NCT00981045|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
269461|NCT00981019|B1|Baseline|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
269462|NCT00981019|P1|Participant Flow|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
269463|NCT00981019|O1|Outcome|Mortality*Incidence*5-year Survival*Early Detection Rate|The survey introduced four different cancer statistics in scenarios about 2 different screening tests. To mask the fact that all statistics stemmed from prostate cancer screening, screening in the scenarios were labeled “X” and “Z”. The survey then introduced test Z, whose effectiveness was described in terms of a reduction of cancer mortality. After responding to the series of outcome questions about test Z, physicians received additional information on the cancer incidence, again followed by the outcome questions. In the next scenario, the survey introduced test X, whose effectiveness was described in terms of an increase in 5-year survival and, in the next step, with additional information on early detection rates. After each step, doctors had to respond to the same outcome questions as they had for test Z. Please not, information on test X and test Z were randomly presented to control for order effects.
269464|NCT00981019|E1|Reported Event|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
269465|NCT00980980|B4|Baseline|Total|Total of all reporting groups
280028|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
269466|NCT00980980|B3|Baseline|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269467|NCT00980980|B2|Baseline|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269468|NCT00980980|B1|Baseline|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269469|NCT00980980|P3|Participant Flow|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269470|NCT00980980|P2|Participant Flow|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269471|NCT00980980|P1|Participant Flow|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269472|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269473|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269474|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269475|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269476|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269477|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269478|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269479|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269480|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269481|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269482|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269483|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269484|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269485|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
280029|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
269487|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269488|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269489|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
269490|NCT00980980|E3|Reported Event|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269491|NCT00980980|E2|Reported Event|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
269492|NCT00980980|E1|Reported Event|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
269493|NCT00980798|B3|Baseline|Total|Total of all reporting groups
269494|NCT00980798|B2|Baseline|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
269495|NCT00980798|B1|Baseline|Placebo|Placebo daily for 16 weeks
269496|NCT00980798|P2|Participant Flow|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
269497|NCT00980798|P1|Participant Flow|Placebo|Placebo daily for 16 weeks
269498|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
269499|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
269500|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
269501|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
269502|NCT00980798|E2|Reported Event|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
269503|NCT00980798|E1|Reported Event|Placebo|Placebo daily for 16 weeks
269504|NCT00980746|B7|Baseline|Total|Total of all reporting groups
269505|NCT00980746|B6|Baseline|Placebo|"Placebo~Placebo : oral route"
269506|NCT00980746|B5|Baseline|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269507|NCT00980746|B4|Baseline|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269508|NCT00980746|B3|Baseline|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269509|NCT00980746|B2|Baseline|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269510|NCT00980746|B1|Baseline|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269511|NCT00980746|P6|Participant Flow|Placebo|"Placebo~Placebo : oral route"
269512|NCT00980746|P5|Participant Flow|ESL 800 mg QD|"ESL 800 mg once-daily~ESL tablets, scored to allow dose titration during the titration period."
269513|NCT00980746|P4|Participant Flow|ESL 800 mg BID|"ESL 800 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
269514|NCT00980746|P3|Participant Flow|ESL 600 mg BID|"ESL 600 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
269515|NCT00980746|P2|Participant Flow|ESL 400 mg BD|"ESL 400 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
269516|NCT00980746|P1|Participant Flow|ESL 1200 mg QD|Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.
269517|NCT00980746|O6|Outcome|Placebo|"Placebo~Placebo : oral route"
269518|NCT00980746|O5|Outcome|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269519|NCT00980746|O4|Outcome|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269520|NCT00980746|O3|Outcome|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269521|NCT00980746|O2|Outcome|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269522|NCT00980746|O1|Outcome|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269523|NCT00980746|E6|Reported Event|Placebo|"Placebo~Placebo : oral route"
269524|NCT00980746|E5|Reported Event|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269525|NCT00980746|E4|Reported Event|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269526|NCT00980746|E3|Reported Event|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
280030|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
269528|NCT00980746|E1|Reported Event|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
269529|NCT00980681|B1|Baseline|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
269530|NCT00980681|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
269531|NCT00980681|O2|Outcome|Time-Of-Flight MRA|Patients benefiting from an MRA with no injection of contrast medium
269532|NCT00980681|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after administration with Dotarem
269533|NCT00980681|E2|Reported Event|Time Of Flight|"Each subject will undergo a TOF Magnetic Resonance Angiography~Time of Flight: Each subject will undergo a TOF MRA"
269534|NCT00980681|E1|Reported Event|Dotarem|"Each subject will receive one injection of Dotarem 0.2ml/kg.~Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg"
269535|NCT00980655|B3|Baseline|Total|Total of all reporting groups
269536|NCT00980655|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269537|NCT00980655|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269538|NCT00980655|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269539|NCT00980655|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269540|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269541|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269542|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269543|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269544|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269545|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269546|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269547|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269548|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269779|NCT00980044|B1|Baseline|Tramadol 200 mg|Medication: Extended release tramadol for 1 week and then placebo given for 1 week
269549|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269550|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269551|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269552|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269553|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269554|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269555|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269556|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269557|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269558|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269559|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269560|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269561|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269562|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269563|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269564|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269565|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269566|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269567|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269568|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269569|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269570|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269571|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269572|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269573|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269574|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269575|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269576|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269577|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269578|NCT00980655|O1|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
269579|NCT00980655|E5|Reported Event|Follow-up|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
269580|NCT00980655|E4|Reported Event|23vPS Dose|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
269581|NCT00980655|E3|Reported Event|13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
269582|NCT00980655|E2|Reported Event|13vPnC Dose 3 Blood Draw to 13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
280031|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
269583|NCT00980655|E1|Reported Event|13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw|All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
269584|NCT00980590|B3|Baseline|Total|Total of all reporting groups
269585|NCT00980590|B2|Baseline|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269586|NCT00980590|B1|Baseline|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269587|NCT00980590|P2|Participant Flow|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269588|NCT00980590|P1|Participant Flow|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269589|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269590|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269591|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269592|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269593|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269594|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269595|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269596|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269597|NCT00980590|E2|Reported Event|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
269598|NCT00980590|E1|Reported Event|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
269599|NCT00980330|B8|Baseline|Total|Total of all reporting groups
269600|NCT00980330|B7|Baseline|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269601|NCT00980330|B6|Baseline|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269602|NCT00980330|B5|Baseline|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269603|NCT00980330|B4|Baseline|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269604|NCT00980330|B3|Baseline|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269605|NCT00980330|B2|Baseline|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269606|NCT00980330|B1|Baseline|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269607|NCT00980330|P7|Participant Flow|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269608|NCT00980330|P6|Participant Flow|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269609|NCT00980330|P5|Participant Flow|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269610|NCT00980330|P4|Participant Flow|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269611|NCT00980330|P3|Participant Flow|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269612|NCT00980330|P2|Participant Flow|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269613|NCT00980330|P1|Participant Flow|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269614|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269615|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269616|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269617|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269618|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269619|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269620|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
270379|NCT00978029|P3|Participant Flow|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
269621|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269622|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269623|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269624|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269625|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269626|NCT00980330|O7|Outcome|All TMC435|Participants in all 6 TMC435 treatment groups combined.
269627|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269628|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269629|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269630|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269631|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269632|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269633|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269634|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269635|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269636|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269637|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269638|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269639|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269640|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269641|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269642|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269643|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269644|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269645|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269646|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269647|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269648|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269649|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269650|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269651|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269652|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269653|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269654|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269655|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269656|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269657|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269658|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269659|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269660|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269661|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269662|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269663|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269664|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269665|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269666|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269667|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269668|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269669|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269670|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269671|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269672|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269673|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269674|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269675|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269676|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269677|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269678|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269679|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269680|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269681|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269682|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269683|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269684|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269685|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269686|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269687|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269780|NCT00980044|P3|Participant Flow|Tramadol 600 mg Daily|Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
269688|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269689|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269690|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269691|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269692|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269693|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269694|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269695|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269696|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269697|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269698|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269699|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269700|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269701|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269702|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269703|NCT00980330|E7|Reported Event|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269704|NCT00980330|E6|Reported Event|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269705|NCT00980330|E5|Reported Event|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
269706|NCT00980330|E4|Reported Event|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
269707|NCT00980330|E3|Reported Event|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
269708|NCT00980330|E2|Reported Event|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
269709|NCT00980330|E1|Reported Event|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
269710|NCT00980278|B3|Baseline|Total|Total of all reporting groups
269711|NCT00980278|B2|Baseline|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269712|NCT00980278|B1|Baseline|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269713|NCT00980278|P2|Participant Flow|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269736|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269714|NCT00980278|P1|Participant Flow|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269715|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269716|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269717|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269718|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269719|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269720|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269721|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269722|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269723|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269724|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269737|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
269725|NCT00980278|E2|Reported Event|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
269726|NCT00980278|E1|Reported Event|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
269727|NCT00980200|B1|Baseline|PB, GW642444 6.25 µg QD, 6.25 µg BID, 12.5 µg QD, and 25 µg QD|All participants received one of the following five treatments in one of the five Treatment Periods from two DPI dispensed on Day 1of each of the five 7-day treatment periods: Placebo (PB), GW642444 6.25 µg once daily (QD) in the evening, GW642444 6.25 µg twice daily (BID), GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening. Participants received their first evening medication dose in the clinic on Day 1 of each of the five treatment periods. The treatments were administered in the morning (AM) and in the evening (PM), approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a 7-day washout period.
269728|NCT00980200|P5|Participant Flow|Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo|Participants received GW642444 25 µg QD in the evening, GW642444 12.5 µg QD in the evening, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, and placebo in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
269729|NCT00980200|P4|Participant Flow|Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID|Participants received GW642444 12.5 µg QD in the evening, GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, and GW642444 6.25 µg BID and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
269730|NCT00980200|P3|Participant Flow|Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD|Participants received GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, GW642444 6.25 µg BID, and GW642444 12.5 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
269731|NCT00980200|P2|Participant Flow|Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD|Participants received placebo, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
269732|NCT00980200|P1|Participant Flow|Sequence 1: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD|Participants received GW642444 6.25 micrograms (µg) twice a day (BID), placebo (pbo), GW642444 12.5 µg once a day (QD) in the evening, GW642444 25 µg QD in the evening, and GW642444 6.25 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a Dry Powder Inhaler (DPI) for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
269733|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269734|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269735|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269775|NCT00980148|E1|Reported Event|Azithromycin Arm|Azithromycin 1 gm oral single dose
269776|NCT00980044|B4|Baseline|Total|Total of all reporting groups
269777|NCT00980044|B3|Baseline|Tramadol 600 mg|Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
269778|NCT00980044|B2|Baseline|Placebo|Medication: Placebo given for two weeks
269738|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269739|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269740|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269741|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269742|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
269743|NCT00980200|E5|Reported Event|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269744|NCT00980200|E4|Reported Event|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269745|NCT00980200|E3|Reported Event|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269746|NCT00980200|E2|Reported Event|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
269747|NCT00980200|E1|Reported Event|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
269748|NCT00980174|B3|Baseline|Total|Total of all reporting groups
269749|NCT00980174|B2|Baseline|Denosumab 60 mg Q6M|
269750|NCT00980174|B1|Baseline|Placebo|
269751|NCT00980174|P2|Participant Flow|Denosumab 60 mg Q6M|
269752|NCT00980174|P1|Participant Flow|Placebo|
269753|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269754|NCT00980174|O1|Outcome|Placebo|
269755|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269756|NCT00980174|O1|Outcome|Placebo|
269757|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269758|NCT00980174|O1|Outcome|Placebo|
269759|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269760|NCT00980174|O1|Outcome|Placebo|
269761|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269762|NCT00980174|O1|Outcome|Placebo|
269763|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
269764|NCT00980174|O1|Outcome|Placebo|
269765|NCT00980174|E2|Reported Event|Denosumab 60 mg Q6M|
269766|NCT00980174|E1|Reported Event|Placebo|
269767|NCT00980148|B3|Baseline|Total|Total of all reporting groups
269768|NCT00980148|B2|Baseline|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
269769|NCT00980148|B1|Baseline|Azithromycin Arm|Azithromycin 1 gm oral single dose
269770|NCT00980148|P2|Participant Flow|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
269771|NCT00980148|P1|Participant Flow|Azithromycin Arm|Azithromycin 1 gm oral single dose
269772|NCT00980148|O2|Outcome|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
269773|NCT00980148|O1|Outcome|Azithromycin Arm|Azithromycin 1 gm oral single dose
269774|NCT00980148|E2|Reported Event|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
269781|NCT00980044|P2|Participant Flow|Placebo|Placebo given for two weeks
269782|NCT00980044|P1|Participant Flow|Tramadol 200 mg Daily|Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
269783|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
269784|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
269785|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
269786|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
269787|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
269788|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
269789|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
269790|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
269791|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
269792|NCT00980044|O3|Outcome|Tramadol 600 mg Daily|Medication: Extended release tramadol
269793|NCT00980044|O2|Outcome|Placebo|Medication
269794|NCT00980044|O1|Outcome|Tramadol 200 mg Daily|Medication: Extended release tramadol
269795|NCT00980044|E3|Reported Event|Tramadol 600 mg|Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
269796|NCT00980044|E2|Reported Event|Placebo|Medication: Placebo for 2 weeks
269797|NCT00980044|E1|Reported Event|Tramadol 200 mg|Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
269798|NCT00980005|B3|Baseline|Total|Total of all reporting groups
269799|NCT00980005|B2|Baseline|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269800|NCT00980005|B1|Baseline|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269801|NCT00980005|P2|Participant Flow|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269802|NCT00980005|P1|Participant Flow|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269803|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269804|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269805|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269806|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269807|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269808|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269809|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269810|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269811|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269812|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269919|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269813|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269814|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269815|NCT00980005|O4|Outcome|Fluzone 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
269816|NCT00980005|O3|Outcome|Flulaval 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
269817|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269818|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269819|NCT00980005|O4|Outcome|Fluzone Les Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
269820|NCT00980005|O3|Outcome|Flulaval Less Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
269821|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269822|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269823|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269824|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269825|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269826|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269827|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269828|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269829|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269830|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269831|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269832|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269833|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269834|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269835|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269836|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269837|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269838|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269839|NCT00980005|E2|Reported Event|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
269840|NCT00980005|E1|Reported Event|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
269841|NCT00979953|B5|Baseline|Total|Total of all reporting groups
269842|NCT00979953|B4|Baseline|Placebo|Four placebo capsules administered orally BID for 14 days
269843|NCT00979953|B3|Baseline|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
269844|NCT00979953|B2|Baseline|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
269845|NCT00979953|B1|Baseline|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
269846|NCT00979953|P4|Participant Flow|Placebo|Four placebo capsules administered orally BID for 14 days
269847|NCT00979953|P3|Participant Flow|Oxycodone CR|One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
269848|NCT00979953|P2|Participant Flow|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
269849|NCT00979953|P1|Participant Flow|ADL5859|One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
269850|NCT00979953|O4|Outcome|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
269851|NCT00979953|O3|Outcome|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
269852|NCT00979953|O2|Outcome|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14"
269853|NCT00979953|O1|Outcome|Placebo|Four placebo capsules administered orally BID for 14 days
269854|NCT00979953|E4|Reported Event|Placebo|Four placebo capsules administered orally BID for 14 days
269855|NCT00979953|E3|Reported Event|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
269856|NCT00979953|E2|Reported Event|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
269857|NCT00979953|E1|Reported Event|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
269858|NCT00979940|B3|Baseline|Total|Total of all reporting groups
269859|NCT00979940|B2|Baseline|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
269860|NCT00979940|B1|Baseline|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
269861|NCT00979940|P2|Participant Flow|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
269862|NCT00979940|P1|Participant Flow|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
269863|NCT00979940|O2|Outcome|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
269864|NCT00979940|O1|Outcome|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
269865|NCT00979940|E2|Reported Event|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
269866|NCT00979940|E1|Reported Event|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
269867|NCT00979901|B5|Baseline|Total|Total of all reporting groups
269868|NCT00979901|B4|Baseline|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
269869|NCT00979901|B3|Baseline|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269870|NCT00979901|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269871|NCT00979901|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269920|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
270064|NCT00979420|B4|Baseline|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
269872|NCT00979901|P4|Participant Flow|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
269873|NCT00979901|P3|Participant Flow|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269874|NCT00979901|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269875|NCT00979901|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269876|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269877|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269878|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269879|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269880|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269881|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269882|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269883|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269884|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269885|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269886|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269887|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269888|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269889|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269890|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269891|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269892|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269893|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269894|NCT00979901|E4|Reported Event|Montelukast 10 mg + Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
269895|NCT00979901|E3|Reported Event|Loratadine 10mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269896|NCT00979901|E2|Reported Event|Montelukast 10mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
269897|NCT00979901|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
269898|NCT00979875|B1|Baseline|Overall Study|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.~Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.~Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.~Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart."
269921|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269922|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269899|NCT00979875|P6|Participant Flow|Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone."
269900|NCT00979875|P5|Participant Flow|Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20."
269901|NCT00979875|P4|Participant Flow|Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone."
269902|NCT00979875|P3|Participant Flow|Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20."
269903|NCT00979875|P2|Participant Flow|Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone."
269904|NCT00979875|P1|Participant Flow|Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20."
269905|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269906|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269907|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269908|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269909|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269910|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269911|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269912|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269913|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269914|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269915|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269916|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269917|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269918|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269923|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269924|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269925|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269926|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269927|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269928|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269929|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269930|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269931|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269932|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269933|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269934|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269935|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269936|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269937|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269938|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269939|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269940|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269941|NCT00979875|E6|Reported Event|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269942|NCT00979875|E5|Reported Event|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
269943|NCT00979875|E4|Reported Event|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269944|NCT00979875|E3|Reported Event|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
269945|NCT00979875|E2|Reported Event|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
269946|NCT00979875|E1|Reported Event|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
269947|NCT00979654|B1|Baseline|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269948|NCT00979654|P1|Participant Flow|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269949|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269950|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269951|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269952|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269953|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
270399|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
269954|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269955|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269956|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269957|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269958|NCT00979654|E1|Reported Event|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
269959|NCT00979628|B4|Baseline|Total|Total of all reporting groups
269960|NCT00979628|B3|Baseline|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
269961|NCT00979628|B2|Baseline|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
269962|NCT00979628|B1|Baseline|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 unitws/kg/day (plus corrective doses of glulisine as needed)"
269963|NCT00979628|P3|Participant Flow|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards."
269964|NCT00979628|P2|Participant Flow|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
269965|NCT00979628|P1|Participant Flow|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
269966|NCT00979628|O3|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
269967|NCT00979628|O2|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
269968|NCT00979628|O1|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
269969|NCT00979628|E3|Reported Event|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
269970|NCT00979628|E2|Reported Event|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
269971|NCT00979628|E1|Reported Event|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
269972|NCT00979615|B3|Baseline|Total|Total of all reporting groups
269973|NCT00979615|B2|Baseline|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269974|NCT00979615|B1|Baseline|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269975|NCT00979615|P2|Participant Flow|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269976|NCT00979615|P1|Participant Flow|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269977|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269978|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269979|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269980|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269981|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269982|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269983|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269984|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269985|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269986|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269987|NCT00979615|E2|Reported Event|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
269988|NCT00979615|E1|Reported Event|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
269989|NCT00979576|B4|Baseline|Total|Total of all reporting groups
270032|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270065|NCT00979420|B3|Baseline|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
269990|NCT00979576|B3|Baseline|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
269991|NCT00979576|B2|Baseline|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
269992|NCT00979576|B1|Baseline|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
269993|NCT00979576|P3|Participant Flow|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
269994|NCT00979576|P2|Participant Flow|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
269995|NCT00979576|P1|Participant Flow|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
269996|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
269997|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
269998|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
269999|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270000|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270001|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270002|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270003|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270004|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270005|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270006|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270007|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270008|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270009|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270010|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270011|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270012|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270013|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270014|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270015|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270033|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270400|NCT00978029|E3|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
270016|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270017|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270018|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270019|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270020|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270021|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270022|NCT00979576|E3|Reported Event|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270023|NCT00979576|E2|Reported Event|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
270024|NCT00979576|E1|Reported Event|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
270025|NCT00978627|B3|Baseline|Total|Total of all reporting groups
270026|NCT00978627|B2|Baseline|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270027|NCT00978627|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270028|NCT00978627|P2|Participant Flow|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270029|NCT00978627|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270030|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270031|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270106|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270034|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270035|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270036|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270037|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270038|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270039|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270040|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270041|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270042|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270043|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270044|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270045|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270046|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270047|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270048|NCT00978627|E2|Reported Event|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270049|NCT00978627|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
270050|NCT00979459|B1|Baseline|All Participants|Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
270051|NCT00979459|P2|Participant Flow|MK-1006 FCT, Then MK-1006 DFC|Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
270052|NCT00979459|P1|Participant Flow|MK-1006 DFC, Then MK-1006 FCT|Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
270053|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
270054|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
270055|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
270056|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
270057|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
270058|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
270059|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
270060|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
270061|NCT00979459|E2|Reported Event|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
270062|NCT00979459|E1|Reported Event|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
270063|NCT00979420|B5|Baseline|Total|Total of all reporting groups
270066|NCT00979420|B2|Baseline|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270067|NCT00979420|B1|Baseline|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270068|NCT00979420|P4|Participant Flow|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270069|NCT00979420|P3|Participant Flow|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270070|NCT00979420|P2|Participant Flow|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
270071|NCT00979420|P1|Participant Flow|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270072|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270073|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270074|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270075|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270076|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270077|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270078|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270079|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270080|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270081|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270082|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270083|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270084|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270085|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270086|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270087|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270088|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270089|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270090|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270091|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270092|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270093|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270094|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270095|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270096|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270097|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270098|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270099|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270100|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270101|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270102|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270103|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270104|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270105|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
280032|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
270107|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270108|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270109|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270110|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270111|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270112|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270113|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270114|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270115|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
270116|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270117|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270118|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270119|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270120|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270121|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270122|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270123|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270124|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270125|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270126|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270127|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270128|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270129|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270130|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270131|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270132|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270133|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270134|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270135|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
270136|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
270137|NCT00979420|E1|Reported Event|Viramune|
270138|NCT00979212|B3|Baseline|Total|Total of all reporting groups
270139|NCT00979212|B2|Baseline|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270140|NCT00979212|B1|Baseline|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270141|NCT00979212|P2|Participant Flow|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270142|NCT00979212|P1|Participant Flow|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270143|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270144|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270145|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270146|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270147|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270148|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270149|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270150|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270151|NCT00979212|E2|Reported Event|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270152|NCT00979212|E1|Reported Event|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
270153|NCT00979199|B1|Baseline|CTCA and PET or SPECT and ECHO or MRI|
270154|NCT00979199|P1|Participant Flow|CTCA and PET or SPECT and ECHO or MRI|
270155|NCT00979199|O1|Outcome|Non Invasive Cardiac Imaging|All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
270156|NCT00979199|E1|Reported Event|Non Invasive Cardiac Imaging|
270157|NCT00979121|B3|Baseline|Total|Total of all reporting groups
270158|NCT00979121|B2|Baseline|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
270159|NCT00979121|B1|Baseline|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
270160|NCT00979121|P2|Participant Flow|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
270161|NCT00979121|P1|Participant Flow|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
270162|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
270163|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin:Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270164|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
270165|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270166|NCT00979121|O2|Outcome|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
270167|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
270168|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
270169|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Patients received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270170|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital."
270171|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270172|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
270173|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270174|NCT00979121|E2|Reported Event|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
270175|NCT00979121|E1|Reported Event|Rosuvastatin|"Half of the subjects were randomized to the active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
270176|NCT00979069|B3|Baseline|Total|Total of all reporting groups
270177|NCT00979069|B2|Baseline|Control Group|No contact control
270178|NCT00979069|B1|Baseline|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
270179|NCT00979069|P2|Participant Flow|Control Group|No contact control
270180|NCT00979069|P1|Participant Flow|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
270181|NCT00979069|O2|Outcome|Control Group|No contact control
280033|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
270182|NCT00979069|O1|Outcome|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
270183|NCT00979069|E2|Reported Event|Control Group|No contact control
270184|NCT00979069|E1|Reported Event|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
270185|NCT00979017|B1|Baseline|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270186|NCT00979017|P1|Participant Flow|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270187|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270188|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270189|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270190|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270191|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270299|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270300|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270301|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning
270192|NCT00979017|E1|Reported Event|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
270193|NCT00978757|B3|Baseline|Total|Total of all reporting groups
270194|NCT00978757|B2|Baseline|Placebo|Placebo: saline solution
270195|NCT00978757|B1|Baseline|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
270196|NCT00978757|P2|Participant Flow|Placebo|Placebo: saline solution
270197|NCT00978757|P1|Participant Flow|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
270198|NCT00978757|O2|Outcome|Placebo|Placebo: saline solution
270199|NCT00978757|O1|Outcome|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
270200|NCT00978757|E2|Reported Event|Placebo|Placebo: saline solution
270201|NCT00978757|E1|Reported Event|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
270202|NCT00978731|B5|Baseline|Total|Total of all reporting groups
270203|NCT00978731|B4|Baseline|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270204|NCT00978731|B3|Baseline|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270205|NCT00978731|B2|Baseline|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270206|NCT00978731|B1|Baseline|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270207|NCT00978731|P4|Participant Flow|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270208|NCT00978731|P3|Participant Flow|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270209|NCT00978731|P2|Participant Flow|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270302|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270303|NCT00978341|E2|Reported Event|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
280034|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
270210|NCT00978731|P1|Participant Flow|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270211|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
270212|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
270213|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270214|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270215|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270216|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270217|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270218|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270219|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270220|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270304|NCT00978341|E1|Reported Event|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270305|NCT00978120|B5|Baseline|Total|Total of all reporting groups
270380|NCT00978029|P2|Participant Flow|SCH 39641 6 Amb a 1-U|6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
270381|NCT00978029|P1|Participant Flow|Placebo|Matching placebo tablet sublingual, once daily
270221|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270222|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270223|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270224|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270225|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270226|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270227|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270228|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270229|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270230|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270382|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
270231|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270232|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270233|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270234|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270235|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270236|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270237|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270238|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270239|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270240|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270241|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270242|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270243|NCT00978731|E4|Reported Event|Participants With Myeloid Blast Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270244|NCT00978731|E3|Reported Event|Participants With CML; BID Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270245|NCT00978731|E2|Reported Event|Participants With Chronic Myelogenous Leukemia(CML);QD Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules: 5 days, on 2 days off; 6 days on, 1 day off; or continuous daily dosing. Participants were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to twice daily (BID) dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270246|NCT00978731|E1|Reported Event|Participants With Accelerated Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
270247|NCT00978445|B1|Baseline|All Participants|all participants recieved all interventions during study
270248|NCT00978445|P2|Participant Flow|Standard/Home|all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
270249|NCT00978445|P1|Participant Flow|Home/Standard|all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
270250|NCT00978445|O2|Outcome|All Participants - Standard Protocol|all participants recieved all interventions during study
270251|NCT00978445|O1|Outcome|All Participants-home Protocol|all participants recieved all interventions during study
270252|NCT00978445|O2|Outcome|All Particpants - Standard Protocol|First and second group with vMetrics
270253|NCT00978445|O1|Outcome|All Participants-Home Protocol|all participants recieved all interventions during study
270254|NCT00978445|E1|Reported Event|All Participants|all participants recieved all interventions during study
270255|NCT00978432|B4|Baseline|Total|Total of all reporting groups
270256|NCT00978432|B3|Baseline|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270257|NCT00978432|B2|Baseline|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270327|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270383|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
270258|NCT00978432|B1|Baseline|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270259|NCT00978432|P3|Participant Flow|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270260|NCT00978432|P2|Participant Flow|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270261|NCT00978432|P1|Participant Flow|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270262|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270263|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270264|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270265|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270266|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270267|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270384|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
270385|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
270268|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270269|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270270|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270271|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270272|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270273|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270274|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270275|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270276|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270277|NCT00978432|E3|Reported Event|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
270349|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
280035|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
270278|NCT00978432|E2|Reported Event|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270279|NCT00978432|E1|Reported Event|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
270280|NCT00978380|B1|Baseline|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
270281|NCT00978380|P1|Participant Flow|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
270282|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
270283|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
270284|NCT00978380|E2|Reported Event|rFXIII Avecia|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Avecia drug.
270285|NCT00978380|E1|Reported Event|rFXIII Novo Nordisk|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Novo Nordisk drug.
270286|NCT00978341|B1|Baseline|All Subjects|Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270287|NCT00978341|P2|Participant Flow|Placebo First Then Pregabalin|First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270288|NCT00978341|P1|Participant Flow|Pregabalin First Then Placebo|First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270289|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270290|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270291|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270292|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270293|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270294|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270295|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270296|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270297|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
270298|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
270306|NCT00978120|B4|Baseline|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270307|NCT00978120|B3|Baseline|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270308|NCT00978120|B2|Baseline|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270309|NCT00978120|B1|Baseline|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270310|NCT00978120|P4|Participant Flow|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270311|NCT00978120|P3|Participant Flow|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270312|NCT00978120|P2|Participant Flow|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270313|NCT00978120|P1|Participant Flow|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270314|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270315|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270316|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270317|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270318|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270319|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270320|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270321|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270322|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270323|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270324|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270325|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270326|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270328|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270329|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270330|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270331|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270332|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270333|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270334|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270335|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270336|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270337|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270338|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270339|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270340|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270341|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270342|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270343|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270344|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270345|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270346|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270347|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270348|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270376|NCT00978029|B3|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
270377|NCT00978029|B2|Baseline|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
270350|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270351|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270352|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270353|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270354|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
270355|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270356|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
270357|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270358|NCT00978120|E4|Reported Event|Severe Asthma, High Dose Vaccine (30mcg)|Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270359|NCT00978120|E3|Reported Event|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270360|NCT00978120|E2|Reported Event|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270361|NCT00978120|E1|Reported Event|Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)|Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
270362|NCT00978042|B3|Baseline|Total|Total of all reporting groups
270363|NCT00978042|B2|Baseline|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
270364|NCT00978042|B1|Baseline|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270365|NCT00978042|P2|Participant Flow|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
270366|NCT00978042|P1|Participant Flow|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270367|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270368|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270369|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
270370|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270371|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
270372|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
270373|NCT00978042|E2|Reported Event|All Treated Participants_ AEs After Repeat Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
270374|NCT00978042|E1|Reported Event|All Treated Participants_ AEs Initial Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
270375|NCT00978029|B4|Baseline|Total|Total of all reporting groups
280036|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
270401|NCT00978029|E2|Reported Event|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
270402|NCT00978029|E1|Reported Event|Placebo|Matching placebo tablet sublingual, once daily
270403|NCT00977938|B5|Baseline|Total|Total of all reporting groups
270404|NCT00977938|B4|Baseline|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270405|NCT00977938|B3|Baseline|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270406|NCT00977938|B2|Baseline|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270407|NCT00977938|B1|Baseline|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270408|NCT00977938|P4|Participant Flow|BMS 12-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
270409|NCT00977938|P3|Participant Flow|BMS 30-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
270410|NCT00977938|P2|Participant Flow|DES 12-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
270411|NCT00977938|P1|Participant Flow|DES 30-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
270412|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270413|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270414|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270415|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270416|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270417|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270418|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270419|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270420|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270421|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270422|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270423|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270424|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270425|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270426|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270427|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270428|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270429|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270430|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
270431|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
280037|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
270432|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
270433|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
270434|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270435|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270436|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270437|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270438|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
270439|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
270440|NCT00977938|E4|Reported Event|HCRI DAPT - BMS 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
270441|NCT00977938|E3|Reported Event|HCRI DAPT - BMS 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
270442|NCT00977938|E2|Reported Event|HCRI DAPT - DES 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
270443|NCT00977938|E1|Reported Event|HCRI DAPT - DES 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
270444|NCT00977808|B1|Baseline|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
270445|NCT00977808|P1|Participant Flow|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
270446|NCT00977808|O2|Outcome|Control: Open-Loop|Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
270447|NCT00977808|O1|Outcome|Experimental: Closed-Loop Model Predictive Control (MPC)|Insulin dosing was performed by a model-predictive control (MPC) algorithm.
270448|NCT00977808|E1|Reported Event|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
270449|NCT00977769|B4|Baseline|Total|Total of all reporting groups
270450|NCT00977769|B3|Baseline|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270451|NCT00977769|B2|Baseline|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270452|NCT00977769|B1|Baseline|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270453|NCT00977769|P3|Participant Flow|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270454|NCT00977769|P2|Participant Flow|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270455|NCT00977769|P1|Participant Flow|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270456|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270457|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270458|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270459|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270460|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270461|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270462|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270463|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270464|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270465|NCT00977769|E3|Reported Event|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
270466|NCT00977769|E2|Reported Event|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
270467|NCT00977769|E1|Reported Event|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
270468|NCT00977704|B1|Baseline|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
270469|NCT00977704|P1|Participant Flow|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
270470|NCT00977704|O1|Outcome|Restylane and Perlane|Single arm safety study of subjects receiving Restylane and Perlane.
270471|NCT00977704|E1|Reported Event|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
270472|NCT00977665|B3|Baseline|Total|Total of all reporting groups
270473|NCT00977665|B2|Baseline|Placebo|placebo tablet for up to 48 weeks.
270474|NCT00977665|B1|Baseline|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270475|NCT00977665|P2|Participant Flow|Placebo|placebo tablet for up to 48 weeks.
270476|NCT00977665|P1|Participant Flow|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270477|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270478|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270479|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270480|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270481|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270482|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270483|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270484|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270485|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270486|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270487|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270488|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270489|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270490|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270491|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270492|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270493|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270494|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270495|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270496|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270497|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270498|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270499|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270500|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270501|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270502|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270503|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
270504|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
270505|NCT00977665|E2|Reported Event|Rasagiline Mesylate|Rasagiline tablet, 1 mg/day for up to 48 weeks.
270506|NCT00977665|E1|Reported Event|Placebo|Placebo tablet for up to 48 weeks.
270507|NCT00977613|B1|Baseline|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
270508|NCT00977613|P1|Participant Flow|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
270509|NCT00977613|O1|Outcome|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
270632|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270510|NCT00977613|E1|Reported Event|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
270511|NCT00977561|B3|Baseline|Total|Total of all reporting groups
270512|NCT00977561|B2|Baseline|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270513|NCT00977561|B1|Baseline|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270514|NCT00977561|P2|Participant Flow|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270515|NCT00977561|P1|Participant Flow|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter*minute (mg/mL*min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270516|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270517|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270518|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270519|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270520|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270521|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270522|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270523|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270524|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270525|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270526|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.
270527|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270528|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270529|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270530|NCT00977561|O1|Outcome|Figitumumab+ Cisplatin (or Carboplatin) + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270531|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270532|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270533|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270534|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270535|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270536|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270537|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270538|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270539|NCT00977561|E2|Reported Event|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
280038|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
270540|NCT00977561|E1|Reported Event|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
270541|NCT00977548|B1|Baseline|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270542|NCT00977548|P1|Participant Flow|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270543|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270544|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270545|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270546|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270547|NCT00977548|E1|Reported Event|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
270548|NCT00977379|B3|Baseline|Total|Total of all reporting groups
270549|NCT00977379|B2|Baseline|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270550|NCT00977379|B1|Baseline|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270551|NCT00977379|P2|Participant Flow|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270552|NCT00977379|P1|Participant Flow|WBRT Followed by Standard of Care|Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (WBRT) in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270553|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270554|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270555|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270556|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270557|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270633|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
270634|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270558|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270559|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270560|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270561|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270562|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270563|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270564|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270565|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270566|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270567|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270568|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270569|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270570|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270635|NCT00977184|O3|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270636|NCT00977184|O2|Outcome|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
270571|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270572|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270573|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270574|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270575|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270576|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270577|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270578|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270579|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270580|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270581|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270582|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270583|NCT00977379|E2|Reported Event|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
270637|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
280039|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
270584|NCT00977379|E1|Reported Event|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
270585|NCT00977314|B3|Baseline|Total|Total of all reporting groups
270586|NCT00977314|B2|Baseline|Pilot Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
270587|NCT00977314|B1|Baseline|Analyzed Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
270588|NCT00977314|P2|Participant Flow|Pilot Group|"Per the protocol, the first five (5) subjects were enrolled in the pilot group of the study to work out the process flow and training of the centers and participants."
270589|NCT00977314|P1|Participant Flow|Analyzed Group|30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.
270590|NCT00977314|O1|Outcome|Global Benefit|The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
270591|NCT00977314|O1|Outcome|HINT (dB) Advantage|"Effectiveness was defined as “Change from Baseline” analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .~An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions."
270592|NCT00977314|O1|Outcome|Medical, Dental, Audiological Safety 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination~Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed~Comprehensive Audiological evaluation at Enrollment and Termination.~No Medical, Dental or Audiological adverse events."
270593|NCT00977314|E1|Reported Event|Incidence of Device- and Procedure-related Adverse Events|Incidence of device- and procedure-related adverse events at 30 days
270594|NCT00977197|B3|Baseline|Total|Total of all reporting groups
270595|NCT00977197|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270596|NCT00977197|B1|Baseline|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270597|NCT00977197|P2|Participant Flow|Placebo|"Subjects randomized to this arm will receive placebo matching the study drug.~Placebo: A matching placebo will be administered twice a day"
270598|NCT00977197|P1|Participant Flow|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.~Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270599|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270600|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270601|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270602|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270603|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270638|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270604|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270605|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270606|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270607|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270608|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270609|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270610|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270611|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270612|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270613|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270614|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270615|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270616|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270617|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270618|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270619|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270620|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270621|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270622|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270623|NCT00977197|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
270624|NCT00977197|E1|Reported Event|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
270625|NCT00977184|B3|Baseline|Total|Total of all reporting groups
270626|NCT00977184|B2|Baseline|Sham rTMS|Subjects receiving sham rTMS.
270627|NCT00977184|B1|Baseline|Real rTMS|Subjects receiving real rTMS
270628|NCT00977184|P2|Participant Flow|Sham rTMS|Subjects receiving sham rTMS.
270629|NCT00977184|P1|Participant Flow|Real rTMS|Subjects receiving real rTMS
270630|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270631|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
270639|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
270640|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270641|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
270642|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270643|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
270644|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270645|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
270646|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270647|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
270648|NCT00977184|O2|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270649|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
270650|NCT00977184|E4|Reported Event|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
270651|NCT00977184|E3|Reported Event|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
270652|NCT00977184|E2|Reported Event|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
270653|NCT00977184|E1|Reported Event|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
270654|NCT00977171|B1|Baseline|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
270655|NCT00977171|P1|Participant Flow|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
270656|NCT00977171|O1|Outcome|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
270657|NCT00977171|E1|Reported Event|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
270658|NCT00977106|B3|Baseline|Total|Total of all reporting groups
270659|NCT00977106|B2|Baseline|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270660|NCT00977106|B1|Baseline|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270661|NCT00977106|P2|Participant Flow|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270662|NCT00977106|P1|Participant Flow|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270663|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270664|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270665|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270666|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270667|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270668|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270669|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270670|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270671|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270672|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270790|NCT00976989|P3|Participant Flow|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270673|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270674|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270675|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270676|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270677|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270678|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270679|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270680|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270681|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270682|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270683|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270684|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270685|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270686|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270687|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270688|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270689|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270690|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270691|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270692|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270693|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270694|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270695|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
271290|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
270696|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270697|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270698|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270699|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270700|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270701|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270702|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270703|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270704|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270705|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270706|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270707|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270708|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270709|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270710|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270711|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270712|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270713|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270714|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270715|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270716|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
271377|NCT00975637|B4|Baseline|Placebo|Placebo: Placebo SC
270717|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270718|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270719|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270720|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270721|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270722|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270723|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270724|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270725|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270726|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270727|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270728|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270729|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270730|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270731|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270732|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270733|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270734|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270735|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270736|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270737|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270738|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270739|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270791|NCT00976989|P2|Participant Flow|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270740|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270741|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270742|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270743|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270744|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270745|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270746|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270747|NCT00977106|E2|Reported Event|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
270748|NCT00977106|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
270749|NCT00977080|B5|Baseline|Total|Total of all reporting groups
270750|NCT00977080|B4|Baseline|Cinacalcet in the Oral Stratum|Oral stratum
270751|NCT00977080|B3|Baseline|Oral Paricalcitol in the Oral Stratum|Oral stratum
270752|NCT00977080|B2|Baseline|Cinacalcet in the IV Stratum|IV stratum
270753|NCT00977080|B1|Baseline|IV Paricalcitol in the IV Stratum|IV stratum
270754|NCT00977080|P4|Participant Flow|Cinacalcet in the Oral Stratum|Oral stratum
270755|NCT00977080|P3|Participant Flow|Oral Paricalcitol in the Oral Stratum|Oral stratum
270756|NCT00977080|P2|Participant Flow|Cinacalcet in the IV Stratum|IV stratum
270757|NCT00977080|P1|Participant Flow|IV Paricalcitol in the IV Stratum|IV stratum
270758|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270759|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270760|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270761|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270762|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270763|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270764|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270765|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270766|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270767|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270768|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270769|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270770|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270771|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270772|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270773|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270774|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270775|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270776|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270777|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270778|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
270779|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
270780|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
270781|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
270782|NCT00977080|E4|Reported Event|Cinacalcet in the Oral Stratum|Oral stratum
270783|NCT00977080|E3|Reported Event|Oral Paricalcitol in the Oral Stratum|Oral stratum
270784|NCT00977080|E2|Reported Event|Cinacalcet in the IV Stratum|IV stratum
270785|NCT00977080|E1|Reported Event|IV Paricalcitol in the IV Stratum|IV stratum
270786|NCT00976989|B4|Baseline|Total|Total of all reporting groups
270787|NCT00976989|B3|Baseline|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270788|NCT00976989|B2|Baseline|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270789|NCT00976989|B1|Baseline|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270997|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270792|NCT00976989|P1|Participant Flow|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270793|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270794|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270795|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270796|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270797|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270798|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270799|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270800|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270801|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270802|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270803|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270804|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270805|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270806|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270807|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270808|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270809|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270810|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270811|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270812|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270813|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270814|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270815|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270816|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270817|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270818|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270819|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270820|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270821|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270822|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270823|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270824|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270825|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270826|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270827|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270828|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270829|NCT00976989|E3|Reported Event|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270830|NCT00976989|E2|Reported Event|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
270831|NCT00976989|E1|Reported Event|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
270832|NCT00976950|B1|Baseline|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270833|NCT00976950|P1|Participant Flow|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270834|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270835|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270836|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270837|NCT00976950|E1|Reported Event|Aptivus and Ritonavir|ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
270838|NCT00976937|B3|Baseline|Total|Total of all reporting groups
270839|NCT00976937|B2|Baseline|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
270840|NCT00976937|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 mg capsule orally QD up to Week 24.
270841|NCT00976937|P2|Participant Flow|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
270842|NCT00976937|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
270843|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270844|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270845|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270846|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270847|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270848|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270849|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270850|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270851|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270852|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270853|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270854|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270855|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270856|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270857|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270858|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270859|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270860|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270861|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270862|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270863|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270864|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270865|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270866|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270867|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270868|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270869|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270870|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270871|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270872|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270873|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270874|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270875|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270876|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270877|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270878|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270879|NCT00976937|E2|Reported Event|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
270880|NCT00976937|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
270881|NCT00976911|B3|Baseline|Total|Total of all reporting groups
270882|NCT00976911|B2|Baseline|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270883|NCT00976911|B1|Baseline|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270884|NCT00976911|P2|Participant Flow|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270885|NCT00976911|P1|Participant Flow|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270886|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270887|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270888|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270889|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270890|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270891|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270902|NCT00976716|B1|Baseline|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270903|NCT00976716|P1|Participant Flow|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
270904|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270892|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270893|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270894|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270895|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270896|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270897|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270898|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270899|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270900|NCT00976911|E2|Reported Event|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
270901|NCT00976911|E1|Reported Event|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
270905|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270906|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
270907|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
270908|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270909|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270910|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270911|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
270912|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270913|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
270914|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270915|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270916|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270917|NCT00976716|E1|Reported Event|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
270918|NCT00976703|B3|Baseline|Total|Total of all reporting groups
270919|NCT00976703|B2|Baseline|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270920|NCT00976703|B1|Baseline|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270921|NCT00976703|P2|Participant Flow|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270922|NCT00976703|P1|Participant Flow|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270923|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270924|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270925|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270926|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270927|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270928|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270929|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
271378|NCT00975637|B3|Baseline|Broda 280 mg|AMG 827: 280 mg SC
270930|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270931|NCT00976703|E2|Reported Event|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
270932|NCT00976703|E1|Reported Event|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
270933|NCT00976677|B3|Baseline|Total|Total of all reporting groups
270934|NCT00976677|B2|Baseline|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270935|NCT00976677|B1|Baseline|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270936|NCT00976677|P2|Participant Flow|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270937|NCT00976677|P1|Participant Flow|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270938|NCT00976677|O2|Outcome|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270939|NCT00976677|O1|Outcome|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270940|NCT00976677|E2|Reported Event|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270941|NCT00976677|E1|Reported Event|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
270942|NCT00976664|B3|Baseline|Total|Total of all reporting groups
270943|NCT00976664|B2|Baseline|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
270944|NCT00976664|B1|Baseline|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
270945|NCT00976664|P2|Participant Flow|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
270946|NCT00976664|P1|Participant Flow|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
270947|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
270948|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
270949|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
270950|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
270951|NCT00976664|E2|Reported Event|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
270952|NCT00976664|E1|Reported Event|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
270953|NCT00976599|B3|Baseline|Total|Total of all reporting groups
270954|NCT00976599|B2|Baseline|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270955|NCT00976599|B1|Baseline|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270956|NCT00976599|P2|Participant Flow|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270957|NCT00976599|P1|Participant Flow|CP-690,550|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270958|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270959|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270960|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270961|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270962|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270963|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270964|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270965|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270966|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270967|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270968|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270969|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270970|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270971|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270972|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270973|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270974|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270975|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270976|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270977|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270978|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270979|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270980|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270981|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270982|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270983|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270984|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270985|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270986|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270987|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270988|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270989|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270990|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270991|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270992|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270993|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270994|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270995|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270996|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271379|NCT00975637|B2|Baseline|Broda 140 mg|AMG 827: 140 mg SC
270998|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
270999|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271000|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271001|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271002|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271003|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271004|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271005|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271006|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271007|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271008|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271009|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271010|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271011|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271012|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271013|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271014|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271015|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271016|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271017|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271018|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271019|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271020|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271021|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271022|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271023|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271024|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271025|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271026|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271027|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271028|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271029|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271030|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271031|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271032|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271033|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271034|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271035|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271036|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271037|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271038|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271039|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271040|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271041|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271042|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271043|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271044|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271045|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271046|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271047|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271048|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271049|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271050|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271051|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271052|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271053|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271054|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271055|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271056|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271057|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271058|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271059|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271060|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271061|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271062|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271063|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271064|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271065|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271066|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271067|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271068|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271069|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271070|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271071|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271072|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271073|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271074|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271075|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271076|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271077|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271078|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271079|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271080|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271081|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271082|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271083|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271084|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271085|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271086|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271087|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271088|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271089|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271090|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271091|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271092|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271093|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271094|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271095|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271096|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271097|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271098|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271099|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271100|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271101|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271102|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271103|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271104|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271105|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271106|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271107|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271108|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271109|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271110|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271111|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271112|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271113|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271114|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271115|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271116|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271117|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271118|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271119|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271120|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271121|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271122|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271123|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271124|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271125|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271126|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271127|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271128|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271129|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271130|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271131|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271132|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271133|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271134|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271135|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271136|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271137|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271138|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271139|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271140|NCT00976599|E2|Reported Event|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271141|NCT00976599|E1|Reported Event|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
271142|NCT00976521|B5|Baseline|Total|Total of all reporting groups
271143|NCT00976521|B4|Baseline|No Local Infusion, no Aspiration|No local infusion of abciximab and no thrombus aspiration
271144|NCT00976521|B3|Baseline|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
271145|NCT00976521|B2|Baseline|Local Infusion, no Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
271146|NCT00976521|B1|Baseline|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
271147|NCT00976521|P4|Participant Flow|No Local Infusion, no Aspiration|"No local infusion of abciximab and no thrombus aspiration.~The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care."
271148|NCT00976521|P3|Participant Flow|No Local Infusion, Thrombus Aspiration|"No local infusion of abciximab, thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed."
271149|NCT00976521|P2|Participant Flow|Local Infusion, no Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.~The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).~If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
271150|NCT00976521|P1|Participant Flow|Local Infusion, Thrombus Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.~After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
271151|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
271152|NCT00976521|O2|Outcome|No Aspiration|No aspiration includes subjects randomized to either the following two arms: abciximab infusion arm without aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion without aspiration, the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter. If randomized to no abciximab without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
271153|NCT00976521|O1|Outcome|Thrombus Aspiration|Thrombus aspiration includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or no abciximab infusion with aspiration. A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter. Multiple passes should be made with contrast injection after each pass until the operator appreciates that no further thrombus is being removed.
271154|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
271155|NCT00976521|O2|Outcome|No Infusion|No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
271156|NCT00976521|O1|Outcome|Abciximab Infusion|Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
271157|NCT00976521|E4|Reported Event|No Local Infusion, No Aspiration|No local infusion of abciximab and no thrombus aspiration.
271158|NCT00976521|E3|Reported Event|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
271159|NCT00976521|E2|Reported Event|Local Infusion, No Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
271160|NCT00976521|E1|Reported Event|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
271161|NCT00976508|B3|Baseline|Total|Total of all reporting groups
271162|NCT00976508|B2|Baseline|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271194|NCT00976482|B1|Baseline|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
271163|NCT00976508|B1|Baseline|Figitumumab 20 mg/kg +Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271164|NCT00976508|P2|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271165|NCT00976508|P1|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271166|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271167|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271168|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271169|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271170|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271171|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271172|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271173|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271174|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271175|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271176|NCT00976508|O2|Outcome|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
271177|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271195|NCT00976482|P1|Participant Flow|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
271196|NCT00976482|O1|Outcome|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
271197|NCT00976482|E1|Reported Event|Pacemaker|implanted Patients
271198|NCT00976456|B3|Baseline|Total|Total of all reporting groups
271178|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271179|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271180|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271181|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271182|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271183|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271184|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271185|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271186|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271187|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271188|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271189|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271190|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271191|NCT00976508|O1|Outcome|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271192|NCT00976508|E2|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
271193|NCT00976508|E1|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
271199|NCT00976456|B2|Baseline|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
271200|NCT00976456|B1|Baseline|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
271201|NCT00976456|P2|Participant Flow|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
271202|NCT00976456|P1|Participant Flow|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
271203|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
271204|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
271205|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
271206|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
271207|NCT00976456|E2|Reported Event|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
271208|NCT00976456|E1|Reported Event|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
271209|NCT00976404|B3|Baseline|Total|Total of all reporting groups
271210|NCT00976404|B2|Baseline|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271211|NCT00976404|B1|Baseline|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271212|NCT00976404|P2|Participant Flow|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271213|NCT00976404|P1|Participant Flow|ART Intensification: Maraviroc + Raltegravir|ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
271214|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271215|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271216|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271217|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271218|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271219|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271220|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271221|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271222|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271223|NCT00976404|O1|Outcome|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271224|NCT00976404|E2|Reported Event|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
271225|NCT00976404|E1|Reported Event|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
271226|NCT00976391|B3|Baseline|Total|Total of all reporting groups
271227|NCT00976391|B2|Baseline|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271228|NCT00976391|B1|Baseline|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271287|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271229|NCT00976391|P2|Participant Flow|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271230|NCT00976391|P1|Participant Flow|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271231|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271232|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271233|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271234|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271235|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271236|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271237|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271238|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271239|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271240|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271241|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271242|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271243|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271244|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271245|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271246|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271247|NCT00976391|E2|Reported Event|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
271288|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271289|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271380|NCT00975637|B1|Baseline|Broda 210 mg|AMG 827: 210 mg SC
271248|NCT00976391|E1|Reported Event|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
271249|NCT00976339|B1|Baseline|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
271250|NCT00976339|P1|Participant Flow|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
271251|NCT00976339|O1|Outcome|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU or 30,000 IU weekly for 1 year
271252|NCT00976339|E1|Reported Event|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU for 1 year
271253|NCT00976274|B3|Baseline|Total|Total of all reporting groups
271254|NCT00976274|B2|Baseline|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
271255|NCT00976274|B1|Baseline|Starch Capsule|5 capsules three times everyday for 12 weeks
271256|NCT00976274|P2|Participant Flow|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
271257|NCT00976274|P1|Participant Flow|Starch Capsule|5 capsules three times everyday for 12 weeks
271258|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
271259|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
271260|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
271261|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
271262|NCT00976274|E2|Reported Event|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
271263|NCT00976274|E1|Reported Event|Starch Capsule|5 capsules three times everyday for 12 weeks
271264|NCT00976248|B1|Baseline|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
271265|NCT00976248|P1|Participant Flow|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
271266|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
271267|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
271268|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
271269|NCT00976248|E1|Reported Event|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
271270|NCT00976209|B3|Baseline|Total|Total of all reporting groups
271271|NCT00976209|B2|Baseline|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
271272|NCT00976209|B1|Baseline|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
271273|NCT00976209|P2|Participant Flow|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
271274|NCT00976209|P1|Participant Flow|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
271275|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
271276|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
271277|NCT00976209|E2|Reported Event|Phenylephrine HCl IR, 10 mg|Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
271278|NCT00976209|E1|Reported Event|Phenylephrine HCl ER, 30 mg|Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days.
271279|NCT00976027|B3|Baseline|Total|Total of all reporting groups
271280|NCT00976027|B2|Baseline|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271281|NCT00976027|B1|Baseline|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271282|NCT00976027|P2|Participant Flow|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271283|NCT00976027|P1|Participant Flow|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271284|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271285|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271286|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271291|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271292|NCT00976027|E2|Reported Event|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
271293|NCT00976027|E1|Reported Event|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
271294|NCT00975975|B1|Baseline|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271295|NCT00975975|P1|Participant Flow|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271296|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271297|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271298|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271299|NCT00975975|E1|Reported Event|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
271300|NCT00975923|B3|Baseline|Total|Total of all reporting groups
271301|NCT00975923|B2|Baseline|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
271302|NCT00975923|B1|Baseline|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
271303|NCT00975923|P2|Participant Flow|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
271304|NCT00975923|P1|Participant Flow|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
271305|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to only a Tool Kit of clinical guidelines and aides for quality improvement
271306|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
271307|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
271308|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
271309|NCT00975923|E2|Reported Event|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement
271310|NCT00975923|E1|Reported Event|Collaborative Group|Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit
271311|NCT00975806|B4|Baseline|Total|Total of all reporting groups
271312|NCT00975806|B3|Baseline|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271313|NCT00975806|B2|Baseline|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271314|NCT00975806|B1|Baseline|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle
271315|NCT00975806|P3|Participant Flow|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271316|NCT00975806|P2|Participant Flow|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271317|NCT00975806|P1|Participant Flow|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271318|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271319|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271320|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271321|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271322|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271323|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271324|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271325|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271326|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271327|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271328|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271329|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271330|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271331|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
271381|NCT00975637|P5|Participant Flow|Broda 70 mg|AMG 827: 70 mg SC
271332|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271333|NCT00975806|O1|Outcome|Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
271334|NCT00975806|O1|Outcome|Overall Lenalidomide and Sunitinib|Oral daily dose of lenalidomide administered on Days 1 to 21 in combination with a single oral daily dose of sunitinib administered on Days 1 to Day 21 of each 21 day-cycle (if ≥ 2 of 6 participants experienced DLTs at Dose Level 1, then sunitinib was administered on Days 1-14 of each 21-day cycle for the remainder of Phase 1 dose levels
271335|NCT00975806|E3|Reported Event|Cohort G|Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
271336|NCT00975806|E2|Reported Event|Cohort F|Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
271337|NCT00975806|E1|Reported Event|Cohort A|Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle
271338|NCT00975780|B3|Baseline|Total|Total of all reporting groups
271339|NCT00975780|B2|Baseline|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
271340|NCT00975780|B1|Baseline|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
271341|NCT00975780|P2|Participant Flow|Enhanced Oral Care|Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
271342|NCT00975780|P1|Participant Flow|Usual Care|"The usual oral care provided at the nursing home~Usual oral care : Usual oral care and feeding positioning"
271343|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
271344|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
271345|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
271346|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
271347|NCT00975780|E2|Reported Event|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
271348|NCT00975780|E1|Reported Event|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
271349|NCT00975715|B3|Baseline|Total|Total of all reporting groups
271350|NCT00975715|B2|Baseline|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271351|NCT00975715|B1|Baseline|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271352|NCT00975715|P2|Participant Flow|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271353|NCT00975715|P1|Participant Flow|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271354|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271355|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271356|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271357|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271358|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271359|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271360|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271361|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271362|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271363|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271364|NCT00975715|E2|Reported Event|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
271365|NCT00975715|E1|Reported Event|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
271366|NCT00975689|B3|Baseline|Total|Total of all reporting groups
271367|NCT00975689|B2|Baseline|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
271368|NCT00975689|B1|Baseline|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
271369|NCT00975689|P2|Participant Flow|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
271370|NCT00975689|P1|Participant Flow|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
271371|NCT00975689|O2|Outcome|Placebo Phase|
271372|NCT00975689|O1|Outcome|NAC Phase|
271373|NCT00975689|E2|Reported Event|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
271374|NCT00975689|E1|Reported Event|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
271375|NCT00975637|B6|Baseline|Total|Total of all reporting groups
271376|NCT00975637|B5|Baseline|Broda 70 mg|AMG 827: 70 mg SC
271401|NCT00975611|B1|Baseline|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
271402|NCT00975611|P1|Participant Flow|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
271403|NCT00975611|O1|Outcome|All Consented Subjects|
271404|NCT00975611|E1|Reported Event|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
271405|NCT00975585|B3|Baseline|Total|Total of all reporting groups
271406|NCT00975585|B2|Baseline|Lotrafilcon B|contact lens
271407|NCT00975585|B1|Baseline|Senofilcon A|contact lens
271408|NCT00975585|P2|Participant Flow|Lotrafilcon B|contact lens
271409|NCT00975585|P1|Participant Flow|Senofilcon A|contact lens
271410|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271411|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271412|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271413|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271414|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271415|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271416|NCT00975585|O2|Outcome|Lotrafilcon B at 4 Weeks|lotrafilcon B contact lens after four weeks of wear
271417|NCT00975585|O1|Outcome|Lotrafilcon B at 2 Weeks|lotrafilcon B contact lens after two weeks of wear
271418|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271419|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271420|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271421|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271422|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
271423|NCT00975585|O1|Outcome|Senofilcon A|contact lens
271424|NCT00975585|E2|Reported Event|Lotrafilcon B|contact lens
271425|NCT00975585|E1|Reported Event|Senofilcon A|contact lens
271426|NCT00975507|B3|Baseline|Total|Total of all reporting groups
271427|NCT00975507|B2|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
271428|NCT00975507|B1|Baseline|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
271429|NCT00975507|P2|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
271430|NCT00975507|P1|Participant Flow|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
271431|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
271432|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
271433|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
271434|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
271435|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
271436|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
271437|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
271438|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
271439|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
271440|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
271441|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
271442|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
271443|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
271444|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
271445|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
271446|NCT00975507|E3|Reported Event|M-M-R™ II + VARIVAX™ (1 Injection)|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
271447|NCT00975507|E2|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
271462|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271448|NCT00975507|E1|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
271449|NCT00975481|B1|Baseline|Entire Study Population|Includes participants randomized to receive placebo first, alprazolam 1 mg first, alprazolam 3 mg first, dimebon 20 mg first, dimebon 40 mg first and dimebon 60 mg first.
271450|NCT00975481|P6|Participant Flow|DIM 60 mg, PBO, DIM 40 mg, ALP 1mg, DIM 20 mg, ALP 3 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention group; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
271451|NCT00975481|P5|Participant Flow|DIM 40 mg, DIM 60 mg, DIM 20 mg, PBO, ALP 3 mg, ALP 1 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
271452|NCT00975481|P4|Participant Flow|DIM 20 mg, DIM 40 mg, ALP 3 mg, DIM 60 mg, ALP 1 mg, PBO|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then alprazolam 1mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
271453|NCT00975481|P3|Participant Flow|ALP 3 mg, DIM 20 mg, ALP 1 mg, DIM 40 mg, PBO, DIM 60 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fourth interventional period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of 7 days was maintained between each dose.
271454|NCT00975481|P2|Participant Flow|ALP 1 mg, ALP 3 mg, PBO, DIM 20 mg, DIM 60 mg, DIM 40 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
271455|NCT00975481|P1|Participant Flow|PBO, ALP 1mg, DIM 60 mg, ALP 3 mg, DIM 40 mg, DIM 20 mg|Placebo (PBO) matched to 3 alprazolam (ALP) capsules and placebo matched to 3 dimebon (DIM) tablets on Day 1 in the first intervention period; followed by alprazolam 1 milligram (mg) capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in fourth intervention period; then dimebon 40 mg tablets and placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
271456|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271457|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271458|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271459|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271460|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271461|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271463|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271464|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271465|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271466|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271467|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271468|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271469|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271470|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271471|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271472|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271473|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271474|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271475|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271476|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271477|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271478|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271479|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271480|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271481|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271482|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271483|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271484|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271485|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271486|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271487|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271488|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271489|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271490|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271491|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271492|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271493|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271494|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271495|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271496|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271497|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271498|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271499|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271500|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271501|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271502|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271503|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271504|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271505|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271506|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271507|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271508|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271509|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271510|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271511|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271512|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271513|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271514|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271515|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271516|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271517|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271518|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271519|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271520|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271521|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271522|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271523|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271524|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271525|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271526|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271527|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271528|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271529|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271530|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271531|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271532|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam tablets, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271533|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271534|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271535|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to 1 dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271536|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271537|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271538|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271539|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271540|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271541|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271542|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271543|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271544|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271545|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271546|NCT00975481|E6|Reported Event|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
271547|NCT00975481|E5|Reported Event|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271548|NCT00975481|E4|Reported Event|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
271549|NCT00975481|E3|Reported Event|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271550|NCT00975481|E2|Reported Event|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271551|NCT00975481|E1|Reported Event|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
271552|NCT00975416|B3|Baseline|Total|Total of all reporting groups
271553|NCT00975416|B2|Baseline|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal Placebo given in the context of cognitive behavioral therapy"
271554|NCT00975416|B1|Baseline|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271555|NCT00975416|P2|Participant Flow|Inpatient Cocaine Placebo|Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
271556|NCT00975416|P1|Participant Flow|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271557|NCT00975416|O2|Outcome|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal placebo given in the context of cognitive behavioral therapy"
271558|NCT00975416|O1|Outcome|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271559|NCT00975416|E3|Reported Event|Inpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271560|NCT00975416|E2|Reported Event|Outpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271561|NCT00975416|E1|Reported Event|Methadone|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
271562|NCT00975286|B3|Baseline|Total|Total of all reporting groups
271563|NCT00975286|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
271564|NCT00975286|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
271565|NCT00975286|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
271566|NCT00975286|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
271567|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271568|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271569|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271570|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271571|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271572|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271573|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271574|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271575|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271576|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271577|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271578|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271579|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271580|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271581|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271582|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271583|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271584|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271585|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271586|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271587|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271588|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271589|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271590|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271591|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
271592|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
271593|NCT00975286|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
271594|NCT00975286|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
271595|NCT00975221|B3|Baseline|Total|Total of all reporting groups
271596|NCT00975221|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271597|NCT00975221|B1|Baseline|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271598|NCT00975221|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271599|NCT00975221|P1|Participant Flow|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271600|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271601|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271602|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271603|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271604|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271636|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271605|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271606|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271607|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271608|NCT00975221|E4|Reported Event|Open-label Phase: Previous Cinacalcet|Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271609|NCT00975221|E3|Reported Event|Open-label Phase: Previous Placebo|Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
271610|NCT00975221|E2|Reported Event|Double-blind Phase: Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.
271611|NCT00975221|E1|Reported Event|Double-blind Phase: Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.
271612|NCT00975195|B3|Baseline|Total|Total of all reporting groups
271613|NCT00975195|B2|Baseline|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271614|NCT00975195|B1|Baseline|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271615|NCT00975195|P2|Participant Flow|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271616|NCT00975195|P1|Participant Flow|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271617|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271618|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271619|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271620|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271652|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271621|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271622|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271623|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271624|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271625|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271626|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271627|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271628|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271629|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271630|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271631|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271632|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271633|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271634|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271635|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271697|NCT00975143|E2|Reported Event|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271637|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271638|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271639|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271640|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271641|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271642|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271643|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271644|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271645|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271646|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271647|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271648|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271649|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271650|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271651|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271698|NCT00975143|E1|Reported Event|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271653|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271654|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271655|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271656|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271657|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271658|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271659|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271660|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271661|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271662|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271663|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271664|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271665|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271666|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271667|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271699|NCT00975130|B1|Baseline|GLM50-SC|Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
271668|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271669|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271670|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271671|NCT00975195|E2|Reported Event|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
271672|NCT00975195|E1|Reported Event|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
271673|NCT00975156|B3|Baseline|Total|Total of all reporting groups
271674|NCT00975156|B2|Baseline|Standard of Care|Conventional physical therapy
271675|NCT00975156|B1|Baseline|Lokomat Intervention|
271676|NCT00975156|P2|Participant Flow|Standard of Care|Conventional physical therapy
271677|NCT00975156|P1|Participant Flow|Lokomat Intervention|
271678|NCT00975156|O3|Outcome|All Participants 6MWD Outcome|Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
271679|NCT00975156|O2|Outcome|Standard of Care 6MWD Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
271680|NCT00975156|O1|Outcome|Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
271681|NCT00975156|O3|Outcome|All Participants 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
271682|NCT00975156|O2|Outcome|Standard of Care 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
271683|NCT00975156|O1|Outcome|Lokomat Intervention 10-meter Walking Test (10mWT) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
271684|NCT00975156|E2|Reported Event|Standard of Care|Conventional physical therapy
271685|NCT00975156|E1|Reported Event|Lokomat Intervention|Robotic-assisted gait therapy
271686|NCT00975143|B3|Baseline|Total|Total of all reporting groups
271687|NCT00975143|B2|Baseline|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271688|NCT00975143|B1|Baseline|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271689|NCT00975143|P2|Participant Flow|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271690|NCT00975143|P1|Participant Flow|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271691|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271692|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271693|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271694|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271695|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271696|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
271700|NCT00975130|P3|Participant Flow|SC-GLM50|Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
271701|NCT00975130|P2|Participant Flow|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
271702|NCT00975130|P1|Participant Flow|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
271703|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
271704|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|Participants received IV GLM at a dose of 2 mg/kg until remission is achieved at which time they were switched to SC GLM at a dose of 50 mg once monthly.
271705|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
271706|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched to subcutaneous golimumab~at a dose of 50 mg once monthly."
271707|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
271708|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271709|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271710|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271711|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271712|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271713|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271714|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271715|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271716|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271717|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271718|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271719|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271720|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271721|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271722|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271723|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
271724|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271725|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271726|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271727|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271728|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271729|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271730|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271731|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271732|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271733|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271734|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271735|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271736|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271737|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271738|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271739|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
271740|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
271741|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
271742|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271743|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271744|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271745|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271746|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271747|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271748|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271749|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271750|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271751|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271752|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271753|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271754|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271755|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271756|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271757|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271758|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271759|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271760|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271761|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271762|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271763|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271764|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271765|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271766|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271767|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271768|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271769|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271770|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271771|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271772|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271773|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271774|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271775|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271776|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271777|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271778|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271779|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271780|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271781|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271782|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271783|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271784|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271785|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271786|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271787|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271788|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271789|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271790|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271791|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271792|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271793|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271794|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271795|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271796|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271797|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271798|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271799|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271800|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271801|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271802|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271803|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271804|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271805|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271806|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271807|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271808|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271809|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271810|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271811|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271812|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271813|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271814|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271815|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271816|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271817|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271818|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271819|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271820|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271821|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271822|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271823|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271824|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271825|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271826|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271827|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271828|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271829|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271830|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271831|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271832|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271833|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271834|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271835|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271836|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271837|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271838|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271839|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271840|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271841|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271842|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271843|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271844|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271845|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271846|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271847|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271848|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271849|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271850|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271851|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271852|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271853|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271854|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271855|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271856|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271857|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271858|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271859|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271860|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271861|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271862|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271863|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271864|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271865|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271866|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271867|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271868|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271869|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271870|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271871|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271872|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271873|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271874|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271875|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271876|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
271877|NCT00975130|O2|Outcome|SC-GLM50|Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
271878|NCT00975130|O1|Outcome|IV-GLM2/SC-GLM50|Intravenous golimumab 2 mg/kg followed by subcutaneous golimumab 50 mg once monthly.
271879|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
271880|NCT00975130|E3|Reported Event|SC-GLM50|Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
271881|NCT00975130|E2|Reported Event|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab~at a dose of 50 mg once monthly."
271882|NCT00975130|E1|Reported Event|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months.
271883|NCT00975000|B3|Baseline|Total|Total of all reporting groups
280040|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
271884|NCT00975000|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271885|NCT00975000|B1|Baseline|Placebo|Participants received placebo orally once daily for 52 weeks.
271886|NCT00975000|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
271887|NCT00975000|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 52 weeks.
271888|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271889|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271890|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271891|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271892|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271893|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271894|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271895|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271896|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271897|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271898|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271899|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271900|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271901|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271902|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271903|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271904|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271905|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
271906|NCT00975000|E2|Reported Event|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
271907|NCT00975000|E1|Reported Event|Placebo|Participants received placebo orally once daily for 52 weeks.
271908|NCT00974974|B3|Baseline|Total|Total of all reporting groups
271909|NCT00974974|B2|Baseline|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271910|NCT00974974|B1|Baseline|IPX066|Investigational product IPX066
271911|NCT00974974|P2|Participant Flow|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271912|NCT00974974|P1|Participant Flow|IPX066|Investigational product IPX066
271913|NCT00974974|O2|Outcome|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271914|NCT00974974|O1|Outcome|IPX066|Investigational product IPX066
271915|NCT00974974|O2|Outcome|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271916|NCT00974974|O1|Outcome|IPX066|Investigational product IPX066
271917|NCT00974974|O2|Outcome|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271918|NCT00974974|O1|Outcome|IPX066|Investigational product IPX066
271919|NCT00974974|E2|Reported Event|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
271920|NCT00974974|E1|Reported Event|IPX066|Investigational product IPX066
271921|NCT00974818|B3|Baseline|Total|Total of all reporting groups
271945|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271946|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271922|NCT00974818|B2|Baseline|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
271923|NCT00974818|B1|Baseline|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
271924|NCT00974818|P2|Participant Flow|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
271925|NCT00974818|P1|Participant Flow|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
271926|NCT00974818|O2|Outcome|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
271927|NCT00974818|O1|Outcome|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
271928|NCT00974818|E2|Reported Event|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
271929|NCT00974818|E1|Reported Event|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
271930|NCT00974571|B4|Baseline|Total|Total of all reporting groups
271931|NCT00974571|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271932|NCT00974571|B2|Baseline|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271933|NCT00974571|B1|Baseline|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271934|NCT00974571|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271935|NCT00974571|P2|Participant Flow|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271936|NCT00974571|P1|Participant Flow|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271937|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271938|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271939|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271940|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271941|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271942|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271943|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271944|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271947|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271948|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271949|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271950|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271951|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271952|NCT00974571|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271953|NCT00974571|E2|Reported Event|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
271954|NCT00974571|E1|Reported Event|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
271955|NCT00974480|B4|Baseline|Total|Total of all reporting groups
271956|NCT00974480|B3|Baseline|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271957|NCT00974480|B2|Baseline|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271958|NCT00974480|B1|Baseline|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271959|NCT00974480|P3|Participant Flow|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271960|NCT00974480|P2|Participant Flow|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271961|NCT00974480|P1|Participant Flow|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271962|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271963|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271964|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271965|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271966|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271967|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271968|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271969|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271970|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271971|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271972|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271973|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271974|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271975|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271976|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271977|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271978|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271979|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271980|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271981|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271982|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271983|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271984|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271985|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271986|NCT00974480|O6|Outcome|Combination of Redermic and Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271987|NCT00974480|O5|Outcome|Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271988|NCT00974480|O4|Outcome|Redermic - Assessor 2|Cream applied twice a day every day, morning and evening for 24 weeks.
271989|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271990|NCT00974480|O2|Outcome|Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271991|NCT00974480|O1|Outcome|Redermic - Assessor 1|Cream applied twice a day every day, morning and evening for 24 weeks.
272017|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
271992|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271993|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271994|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271995|NCT00974480|E3|Reported Event|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
271996|NCT00974480|E2|Reported Event|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
271997|NCT00974480|E1|Reported Event|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
271998|NCT00974311|B3|Baseline|Total|Total of all reporting groups
271999|NCT00974311|B2|Baseline|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272000|NCT00974311|B1|Baseline|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272001|NCT00974311|P2|Participant Flow|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272002|NCT00974311|P1|Participant Flow|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272003|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272004|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272005|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272006|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272007|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272008|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272009|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272010|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272011|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272012|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272013|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272014|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272015|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272016|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272018|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272019|NCT00974311|E2|Reported Event|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272020|NCT00974311|E1|Reported Event|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
272021|NCT00974246|B1|Baseline|Baseline Characteristics|Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs.
272022|NCT00974246|P1|Participant Flow|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
272023|NCT00974246|O1|Outcome|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
272024|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
272025|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
272026|NCT00974246|E1|Reported Event|Adverse Events|All enrolled subjects.
272027|NCT00974220|B3|Baseline|Total|Total of all reporting groups
272028|NCT00974220|B2|Baseline|Fentanyl - Placebo (Order)|nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.
272029|NCT00974220|B1|Baseline|Placebo - Fentanyl (Order)|nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.
272030|NCT00974220|P2|Participant Flow|Fentanyl - Placebo (Order)|nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
272031|NCT00974220|P1|Participant Flow|Placebo - Fentanyl (Order)|nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2
272032|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
272033|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
272034|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
272035|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
272036|NCT00974220|E2|Reported Event|Fentanyl|nebulized fentanyl citrate (50 mcg)
272037|NCT00974220|E1|Reported Event|Placebo|nebulized 0.9% saline placebo
272038|NCT00974090|B3|Baseline|Total|Total of all reporting groups
272039|NCT00974090|B2|Baseline|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272040|NCT00974090|B1|Baseline|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272041|NCT00974090|P2|Participant Flow|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272042|NCT00974090|P1|Participant Flow|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272043|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272044|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272045|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272046|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272047|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272048|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272049|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272050|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
272051|NCT00974090|E4|Reported Event|Teneli/Teneli + SU (Data Through Week 52)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
272052|NCT00974090|E3|Reported Event|Placebo/Teneli + SU (Data From Week 12 to Week 52)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
272053|NCT00974090|E2|Reported Event|Teneli/Teneli + SU (Data Through Week 12)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
272054|NCT00974090|E1|Reported Event|Placebo/Teneli + SU (Data Through Week 12)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
272088|NCT00973765|O1|Outcome|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
272055|NCT00974051|B1|Baseline|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
272056|NCT00974051|P3|Participant Flow|20% Basal Reduction First, Then Control, Then Terbutaline|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
272057|NCT00974051|P2|Participant Flow|Terbutaline First, Then 20% Basal Reduction, Then Control|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
272058|NCT00974051|P1|Participant Flow|Control First, Then Terbutaline, Then 20% Basal Reduction|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
272059|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
272060|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
272061|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
272062|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
272063|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
272064|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
272065|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
272066|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
272067|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
272068|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
272069|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
272070|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
272071|NCT00974051|E4|Reported Event|20% Basal Reduction Arm|During 20% basal reduction night
272072|NCT00974051|E3|Reported Event|Terbutaline Arm|During turbutaline intervention night
272073|NCT00974051|E2|Reported Event|Control Arm|during control intervention night
272074|NCT00974051|E1|Reported Event|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
272075|NCT00973921|B1|Baseline|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272076|NCT00973921|P1|Participant Flow|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272077|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272078|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272079|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272080|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272081|NCT00973921|E1|Reported Event|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
272082|NCT00973765|B3|Baseline|Total|Total of all reporting groups
272083|NCT00973765|B2|Baseline|Placebo|Matched placebo 2 pills po BID x 7 days
272084|NCT00973765|B1|Baseline|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
272085|NCT00973765|P2|Participant Flow|Placebo|Matched placebo 2 pills po BID x 7 days
272086|NCT00973765|P1|Participant Flow|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
272087|NCT00973765|O2|Outcome|Placebo|Matched placebo 2 pills po BID x 7 days
272089|NCT00973765|E2|Reported Event|Placebo|Matched placebo 2 pills po BID x 7 days
272090|NCT00973765|E1|Reported Event|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
272091|NCT00973739|B1|Baseline|Lapatinib|Lapatinib will be administered
272092|NCT00973739|P1|Participant Flow|Lapatinib|Lapatinib will be administered
272093|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
272094|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
272095|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
272096|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
272097|NCT00973739|E1|Reported Event|Lapatinib|Lapatinib will be administered
272098|NCT00973700|B6|Baseline|Total|Total of all reporting groups
272099|NCT00973700|B5|Baseline|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272100|NCT00973700|B4|Baseline|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272101|NCT00973700|B3|Baseline|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272102|NCT00973700|B2|Baseline|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272103|NCT00973700|B1|Baseline|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272104|NCT00973700|P5|Participant Flow|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272105|NCT00973700|P4|Participant Flow|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272106|NCT00973700|P3|Participant Flow|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272107|NCT00973700|P2|Participant Flow|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272108|NCT00973700|P1|Participant Flow|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272109|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272110|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272111|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272112|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272113|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272114|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272115|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272116|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272117|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272118|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272119|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272120|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272121|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272122|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272123|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272124|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272125|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272126|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272127|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272128|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272129|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272130|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272131|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272132|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272133|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272134|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272135|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272136|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
272137|NCT00973700|O4|Outcome|15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
272138|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
272139|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; two doses on day 1
272140|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
272141|NCT00973700|O1|Outcome|15_1_22|A/H1N1 on study days 1 and 22
272142|NCT00973700|O1|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272143|NCT00973700|E11|Reported Event|2x15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272144|NCT00973700|E10|Reported Event|15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272145|NCT00973700|E9|Reported Event|7.5adj_1_22 (3 to <9 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272146|NCT00973700|E8|Reported Event|2x15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272147|NCT00973700|E7|Reported Event|15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272148|NCT00973700|E6|Reported Event|7.5adj_1_22 (9 to 17 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272149|NCT00973700|E5|Reported Event|2x15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
272150|NCT00973700|E4|Reported Event|15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
272151|NCT00973700|E3|Reported Event|7.5adj_1_22 (18-64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
272152|NCT00973700|E2|Reported Event|7.5adj_1_8 (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
272153|NCT00973700|E1|Reported Event|2x7.5adj (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; two doses on day 1
272154|NCT00973622|B3|Baseline|Total|Total of all reporting groups
272155|NCT00973622|B2|Baseline|Nonsmokers|
272156|NCT00973622|B1|Baseline|Smokers|
272157|NCT00973622|P2|Participant Flow|Non-smokers|Healthy adult non-smokers who were between the ages of aged 19-55 years.
272158|NCT00973622|P1|Participant Flow|Smokers|Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study.
272159|NCT00973622|O2|Outcome|Non-smokers|Healthy adult non-smokers aged 19-55
272160|NCT00973622|O1|Outcome|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
272161|NCT00973622|E2|Reported Event|Non-smokers|Healthy adult non-smokers aged 19-55
272162|NCT00973622|E1|Reported Event|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
272163|NCT00973479|B3|Baseline|Total|Total of all reporting groups
272164|NCT00973479|B2|Baseline|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272165|NCT00973479|B1|Baseline|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272166|NCT00973479|P2|Participant Flow|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272167|NCT00973479|P1|Participant Flow|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272168|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272169|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272170|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272171|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272172|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272173|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272190|NCT00973362|O1|Outcome|FDA-Approved DNA Test|A FDA-Approved HPV DNA Test is the comparator assay,
280041|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
272174|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272175|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272176|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
272177|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
272178|NCT00973479|E4|Reported Event|Combined Golimumab|Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
272179|NCT00973479|E3|Reported Event|Golimumab 2 mg/kg + MTX|Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
272180|NCT00973479|E2|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24|Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
272181|NCT00973479|E1|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16|Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
272182|NCT00973362|B3|Baseline|Total|Total of all reporting groups
272183|NCT00973362|B2|Baseline|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272184|NCT00973362|B1|Baseline|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272185|NCT00973362|P2|Participant Flow|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).~There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period."
272186|NCT00973362|P1|Participant Flow|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272187|NCT00973362|O1|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
272188|NCT00973362|O2|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
272189|NCT00973362|O1|Outcome|APTIMA HPV Assay|APTIMA HPV Assay Performed on the Tigris System
272377|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272191|NCT00973362|O1|Outcome|APTIMA HPV Assay|"The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272192|NCT00973362|E2|Reported Event|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272193|NCT00973362|E1|Reported Event|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
272194|NCT00973349|B17|Baseline|Total|Total of all reporting groups
272195|NCT00973349|B16|Baseline|30 w/o MF59 (≥ 65)|1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
272196|NCT00973349|B15|Baseline|15_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
272197|NCT00973349|B14|Baseline|15_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
272198|NCT00973349|B13|Baseline|15 w/o MF59 (≥ 65)|1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
272199|NCT00973349|B12|Baseline|7.5_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
272200|NCT00973349|B11|Baseline|7.5_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
272201|NCT00973349|B10|Baseline|7.5 w/o MF59 (≥ 65)|1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
272202|NCT00973349|B9|Baseline|3.75_(50)MF59 (≥ 65 )|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
272203|NCT00973349|B8|Baseline|30 w/o MF59 (18 to 64)|1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
272204|NCT00973349|B7|Baseline|15_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
272205|NCT00973349|B6|Baseline|15_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
272206|NCT00973349|B5|Baseline|15 w/o MF59 (18 to 64)|1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
272207|NCT00973349|B4|Baseline|7.5_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
272208|NCT00973349|B3|Baseline|7.5_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
272209|NCT00973349|B2|Baseline|7.5 w/o MF59 (18 to 64)|1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
272210|NCT00973349|B1|Baseline|3.75_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
272211|NCT00973349|P16|Participant Flow|30 w/o MF59(≥ 65 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272212|NCT00973349|P15|Participant Flow|15_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272213|NCT00973349|P14|Participant Flow|15_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272214|NCT00973349|P13|Participant Flow|15 w/o MF59 (≥ 65 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272215|NCT00973349|P12|Participant Flow|7.5_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272216|NCT00973349|P11|Participant Flow|7.5_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272217|NCT00973349|P10|Participant Flow|7.5 w/o MF59 (≥ 65 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272218|NCT00973349|P9|Participant Flow|3.75_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272219|NCT00973349|P8|Participant Flow|30 w/o MF59(18-64 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272220|NCT00973349|P7|Participant Flow|15_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272221|NCT00973349|P6|Participant Flow|15_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272222|NCT00973349|P5|Participant Flow|15 w/o MF59 (18-64 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272223|NCT00973349|P4|Participant Flow|7.5_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272224|NCT00973349|P3|Participant Flow|7.5_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272225|NCT00973349|P2|Participant Flow|7.5 w/o MF59 (18-64 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272226|NCT00973349|P1|Participant Flow|3.75_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272227|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272228|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272229|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272230|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272231|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272232|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272233|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272234|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272235|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272236|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272237|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272238|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272239|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272240|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272241|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272242|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272243|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272244|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272245|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272246|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272247|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272248|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272249|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272250|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272251|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272252|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272253|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272254|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272255|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272256|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272257|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272258|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272259|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272260|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272261|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272262|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272263|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272264|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272265|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272266|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272267|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272268|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272269|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272270|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272271|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272272|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272273|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272274|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272275|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272276|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272277|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272278|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
280042|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
272279|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272280|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272281|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272282|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272283|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272284|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272285|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272286|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272287|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272288|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272289|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272290|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272291|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272292|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272293|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272294|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272295|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272296|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272297|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272298|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272299|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
272300|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272301|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
272302|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
272303|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272304|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
272305|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
272306|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
272307|NCT00973349|E16|Reported Event|30 w/o MF59 (≥65 Yrs)|1 dose of 30 µg A/H1N1
272308|NCT00973349|E15|Reported Event|15_(100)MF59 (≥65 Yrs)|100% of MF59 with 15 µg A/H1N1 antigen
272309|NCT00973349|E14|Reported Event|15_(50)MF59 (≥65 Yrs)|50% of MF59 with 15 µg A/H1N1 antigen
272310|NCT00973349|E13|Reported Event|15 w/o MF59 (≥ 65 Yrs)|1 dose of 15 µg A/H1N1
272311|NCT00973349|E12|Reported Event|7.5_(100)MF59 (≥65 Yrs)|100% of MF59 with 7.5 µg A/H1N1 antigen
272312|NCT00973349|E11|Reported Event|7.5_(50)MF59 (≥65 Yrs)|50% of MF59 with 7.5 µg A/H1N1 antigen
272313|NCT00973349|E10|Reported Event|7.5 w/o MF59 (≥65 Yrs)|1 dose of 7.5 µg A/H1N1
272314|NCT00973349|E9|Reported Event|3.75_(50)MF59 (Above 65 Yrs)|50% of MF59 with the lowest amount of A/H1N1 antigen
272315|NCT00973349|E8|Reported Event|30 w/o MF59|1 dose of 30 µg A/H1N1
272316|NCT00973349|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272317|NCT00973349|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272318|NCT00973349|E5|Reported Event|15 w/o MF59|1 dose of 15 µg A/H1N1
272319|NCT00973349|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272320|NCT00973349|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272321|NCT00973349|E2|Reported Event|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1
272322|NCT00973349|E1|Reported Event|3.75_(50)MF59|50% of MF59 with the lowest amount of A/H1N1 antigen
272323|NCT00972959|B1|Baseline|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272324|NCT00972959|P1|Participant Flow|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272378|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272379|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272325|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272326|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272327|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272328|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272329|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272330|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272331|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272332|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272333|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272380|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272381|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272382|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272334|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272335|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272336|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272337|NCT00972959|E1|Reported Event|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
272338|NCT00972816|B9|Baseline|Total|Total of all reporting groups
272339|NCT00972816|B8|Baseline|30 Without MF59|1 dose of 30 µg A/H1N1
272340|NCT00972816|B7|Baseline|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272341|NCT00972816|B6|Baseline|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272342|NCT00972816|B5|Baseline|15 Without MF59|1 dose of 15 µg A/H1N1
272343|NCT00972816|B4|Baseline|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272344|NCT00972816|B3|Baseline|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272345|NCT00972816|B2|Baseline|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272346|NCT00972816|B1|Baseline|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272347|NCT00972816|P8|Participant Flow|30_(0) MF59|30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
272348|NCT00972816|P7|Participant Flow|15_(100) MF59|15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
272349|NCT00972816|P6|Participant Flow|15_(50) MF59|15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
272350|NCT00972816|P5|Participant Flow|15_(0) MF59|15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
272351|NCT00972816|P4|Participant Flow|7.5_(100)MF59|7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
272352|NCT00972816|P3|Participant Flow|7.5_(50)MF59|7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
272353|NCT00972816|P2|Participant Flow|7.5_(0) MF59|7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
272354|NCT00972816|P1|Participant Flow|3.75_(50) MF59|3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
272355|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272356|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272357|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272358|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272359|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272360|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272361|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272362|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272363|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272364|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272365|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272366|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272367|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272368|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272369|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272370|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272371|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272372|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272373|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272374|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272375|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272376|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272383|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272384|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272385|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272386|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272387|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272388|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272389|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272390|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272391|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272392|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272393|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272394|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272395|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272396|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272397|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272398|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272399|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272400|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272401|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272402|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272403|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272404|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272405|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272406|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272407|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272408|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272409|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272410|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272411|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272412|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272413|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272414|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272415|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272416|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272417|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272418|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272419|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
272420|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272421|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272422|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
272423|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272424|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272425|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272426|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272427|NCT00972816|E8|Reported Event|30 Without MF59|1 dose of 30 µg A/H1N1
272428|NCT00972816|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
272429|NCT00972816|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
272430|NCT00972816|E5|Reported Event|15 Without MF59|1 dose of 15 µg A/H1N1
272431|NCT00972816|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
272432|NCT00972816|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
272433|NCT00972816|E2|Reported Event|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
272434|NCT00972816|E1|Reported Event|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
272435|NCT00972777|B3|Baseline|Total|Total of all reporting groups
272436|NCT00972777|B2|Baseline|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272437|NCT00972777|B1|Baseline|Besifloxacin|0.6% ophthalmic suspension
272438|NCT00972777|P2|Participant Flow|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272439|NCT00972777|P1|Participant Flow|Besifloxacin|0.6% ophthalmic suspension
272440|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272441|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
272442|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272443|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
272444|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272445|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
272446|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272447|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
272448|NCT00972777|E2|Reported Event|Vehicle|Vehicle of besifloxacin ophthalmic suspension
272449|NCT00972777|E1|Reported Event|Besifloxacin|0.6% ophthalmic suspension
272450|NCT00972738|B4|Baseline|Total|Total of all reporting groups
272451|NCT00972738|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272452|NCT00972738|B2|Baseline|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272453|NCT00972738|B1|Baseline|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272454|NCT00972738|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272455|NCT00972738|P2|Participant Flow|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272456|NCT00972738|P1|Participant Flow|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272457|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272458|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272459|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272460|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272461|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272462|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272463|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272464|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272465|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272466|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272467|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272468|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272469|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272470|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272471|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272472|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272473|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272474|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272475|NCT00972738|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272476|NCT00972738|E2|Reported Event|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272477|NCT00972738|E1|Reported Event|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
272478|NCT00972621|B3|Baseline|Total|Total of all reporting groups
272479|NCT00972621|B2|Baseline|Viscoat|Currently marketed viscoelastic
272480|NCT00972621|B1|Baseline|Vitrax II|Investigational dispersive viscoelastic
272481|NCT00972621|P2|Participant Flow|Viscoat|Currently marketed viscoelastic
272482|NCT00972621|P1|Participant Flow|Vitrax II|Investigational dispersive viscoelastic
272483|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
272484|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
272485|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
272486|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
272487|NCT00972621|E2|Reported Event|Viscoat|Currently marketed viscoelastic
272488|NCT00972621|E1|Reported Event|Vitrax II|Investigational dispersive viscoelastic
272489|NCT00972595|B1|Baseline|All Participants|All Randomized Participants
272490|NCT00972595|P2|Participant Flow|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
272491|NCT00972595|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272492|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272493|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
272494|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272495|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
272496|NCT00972595|E2|Reported Event|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
272529|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272497|NCT00972595|E1|Reported Event|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272498|NCT00972543|B3|Baseline|Total|Total of all reporting groups
272499|NCT00972543|B2|Baseline|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272500|NCT00972543|B1|Baseline|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272501|NCT00972543|P2|Participant Flow|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272502|NCT00972543|P1|Participant Flow|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272503|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272504|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272505|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272506|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272507|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272508|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272509|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272510|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272511|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272512|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272513|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272514|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272515|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272516|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272517|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272518|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272519|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272520|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272521|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272522|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272523|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272524|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272525|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272526|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272527|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272528|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272634|NCT00972283|B3|Baseline|Total|Total of all reporting groups
280043|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
272530|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272531|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272532|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272533|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272534|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272535|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272536|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272537|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272538|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272539|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272540|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272541|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272542|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272543|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272544|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272545|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272546|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272547|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272548|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272549|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272550|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272551|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272552|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272553|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272554|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272555|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272556|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272557|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272558|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272559|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272560|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272561|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272731|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272562|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272563|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272564|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272565|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272566|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272567|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272568|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272569|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272570|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272571|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272572|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272573|NCT00972543|E2|Reported Event|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272574|NCT00972543|E1|Reported Event|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
272575|NCT00972530|B3|Baseline|Total|Total of all reporting groups
272576|NCT00972530|B2|Baseline|Immobilisation|48 hours postinjection rest
272577|NCT00972530|B1|Baseline|Activity|Normal activity without restrictions
272578|NCT00972530|P2|Participant Flow|Immobilisation|48 hours postinjection rest
272579|NCT00972530|P1|Participant Flow|Activity|Normal activity without restrictions
272580|NCT00972530|O2|Outcome|Immobilisation|48 hours postinjection rest
272581|NCT00972530|O1|Outcome|Activity|Normal activity without restrictions
272582|NCT00972530|E2|Reported Event|Immobilisation|48 hours postinjection rest
272583|NCT00972530|E1|Reported Event|Activity|Normal activity without restrictions
272584|NCT00972478|B3|Baseline|Total|Total of all reporting groups
272585|NCT00972478|B2|Baseline|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272586|NCT00972478|B1|Baseline|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272587|NCT00972478|P2|Participant Flow|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272588|NCT00972478|P1|Participant Flow|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272589|NCT00972478|O2|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272590|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272591|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272592|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272593|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272594|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272595|NCT00972478|E2|Reported Event|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272596|NCT00972478|E1|Reported Event|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
272597|NCT00972374|B4|Baseline|Total|Total of all reporting groups
272598|NCT00972374|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272599|NCT00972374|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272600|NCT00972374|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272601|NCT00972374|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272602|NCT00972374|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272603|NCT00972374|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272604|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272605|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272606|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272607|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272608|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272609|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272610|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272611|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272612|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272613|NCT00972374|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
272614|NCT00972374|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272615|NCT00972374|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
272616|NCT00972335|B1|Baseline|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
272617|NCT00972335|P1|Participant Flow|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
272618|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
272619|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
272620|NCT00972335|E1|Reported Event|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
272621|NCT00972322|B3|Baseline|Total|Total of all reporting groups
272622|NCT00972322|B2|Baseline|Placebo|Placebo to MK-8245, twice daily for 28 days
272623|NCT00972322|B1|Baseline|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272624|NCT00972322|P2|Participant Flow|Placebo|Placebo to MK-8245, twice daily for 28 days
272625|NCT00972322|P1|Participant Flow|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272626|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
272627|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272628|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
272629|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272630|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
272631|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272632|NCT00972322|E2|Reported Event|Placebo|Placebo to MK-8245, twice daily for 28 days
272633|NCT00972322|E1|Reported Event|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
272635|NCT00972283|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272636|NCT00972283|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272637|NCT00972283|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272638|NCT00972283|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272639|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272640|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272641|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272642|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272643|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272644|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272645|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272646|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272647|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272648|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272649|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272650|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272651|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272652|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272653|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272766|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively during gastric bypass
272654|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272655|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272656|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272657|NCT00972283|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272658|NCT00972283|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
272659|NCT00972244|B6|Baseline|Total|Total of all reporting groups
272660|NCT00972244|B5|Baseline|Placebo|Placebo Comparator
272661|NCT00972244|B4|Baseline|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272662|NCT00972244|B3|Baseline|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272663|NCT00972244|B2|Baseline|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272664|NCT00972244|B1|Baseline|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272665|NCT00972244|P5|Participant Flow|Placebo|Placebo Comparator
272666|NCT00972244|P4|Participant Flow|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272667|NCT00972244|P3|Participant Flow|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272668|NCT00972244|P2|Participant Flow|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272669|NCT00972244|P1|Participant Flow|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272670|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
272671|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272672|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272673|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272674|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272675|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
272676|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272677|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272678|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272679|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272680|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
272681|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272682|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272683|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272684|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272685|NCT00972244|E5|Reported Event|Placebo|Placebo Comparator
272686|NCT00972244|E4|Reported Event|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
272687|NCT00972244|E3|Reported Event|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
272688|NCT00972244|E2|Reported Event|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
272689|NCT00972244|E1|Reported Event|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
272690|NCT00972205|B1|Baseline|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272691|NCT00972205|P1|Participant Flow|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272692|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272693|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272694|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272852|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
272695|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272696|NCT00972205|E1|Reported Event|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
272697|NCT00972153|B4|Baseline|Total|Total of all reporting groups
272698|NCT00972153|B3|Baseline|Device Deployed and Activated|
272699|NCT00972153|B2|Baseline|Device Attached, Not Activated|
272700|NCT00972153|B1|Baseline|No Device Used|
272701|NCT00972153|P3|Participant Flow|Device Deployed and Activated|
272702|NCT00972153|P2|Participant Flow|Device Attached, Not Activated|
272703|NCT00972153|P1|Participant Flow|No Device Used|
272704|NCT00972153|O3|Outcome|Device Deployed and Activated|
272705|NCT00972153|O2|Outcome|Device Attached, Not Activated|
272706|NCT00972153|O1|Outcome|No Device Used|
272707|NCT00972153|O3|Outcome|Device Deployed and Activated|
272708|NCT00972153|O2|Outcome|Device Attached, Not Activated|
272709|NCT00972153|O1|Outcome|No Device Used|
272710|NCT00972153|E3|Reported Event|Device Deployed and Activated|
272711|NCT00972153|E2|Reported Event|Device Attached, Not Activated|
272712|NCT00972153|E1|Reported Event|No Device Used|
272713|NCT00972088|B1|Baseline|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
272714|NCT00972088|P1|Participant Flow|a Single Arm Group, Patients With Ano Rectal Disease|patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
272715|NCT00972088|O1|Outcome|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
272716|NCT00972088|E1|Reported Event|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
272717|NCT00972023|B1|Baseline|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
272718|NCT00972023|P1|Participant Flow|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
272719|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
272720|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
272721|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
272722|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
272723|NCT00972023|E1|Reported Event|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
272724|NCT00971997|B1|Baseline|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272725|NCT00971997|P1|Participant Flow|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272726|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272727|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272728|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272729|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272730|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272732|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272733|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272734|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272735|NCT00971997|O3|Outcome|Lispro 50/50 Three Times Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272736|NCT00971997|O2|Outcome|Lispro 50/50 Twice Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272737|NCT00971997|O1|Outcome|Lispro 50/50 Once Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272738|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272739|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272740|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272741|NCT00971997|E1|Reported Event|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
272742|NCT00971932|B1|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272743|NCT00971932|P1|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272744|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272745|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272746|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272747|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272767|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272748|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272749|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272750|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272751|NCT00971932|E1|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
272752|NCT00971841|B1|Baseline|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
272753|NCT00971841|P1|Participant Flow|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
272754|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
272755|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
272756|NCT00971841|E1|Reported Event|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
272757|NCT00971789|B1|Baseline|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
272758|NCT00971789|P1|Participant Flow|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
272759|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
272760|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
272761|NCT00971789|E1|Reported Event|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
272762|NCT00971750|B1|Baseline|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272763|NCT00971750|P1|Participant Flow|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272764|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
272765|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272768|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
272769|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272770|NCT00971750|E1|Reported Event|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
272771|NCT00971633|B1|Baseline|All Participants|All randomized participants
272772|NCT00971633|P6|Participant Flow|U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet|U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
272773|NCT00971633|P5|Participant Flow|U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet|U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
272774|NCT00971633|P4|Participant Flow|OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet|OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
272775|NCT00971633|P3|Participant Flow|U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet|U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
272776|NCT00971633|P2|Participant Flow|U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet|U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.
272777|NCT00971633|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
272778|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
272779|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272780|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
272781|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
272782|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272783|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
272784|NCT00971633|E3|Reported Event|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
272785|NCT00971633|E2|Reported Event|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
272786|NCT00971633|E1|Reported Event|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
272787|NCT00971620|B3|Baseline|Total|Total of all reporting groups
272788|NCT00971620|B2|Baseline|Placebo/Saline|Saline intralesional injection
272789|NCT00971620|B1|Baseline|BTX-A|BTX-A intralesional injection
272790|NCT00971620|P2|Participant Flow|Placebo/Saline|Saline intralesional injection
272791|NCT00971620|P1|Participant Flow|BTX-A|BTX-A intralesional injection
272792|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
272793|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
272794|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
272795|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
272796|NCT00971620|E2|Reported Event|Placebo/Saline|Saline intralesional injection
272797|NCT00971620|E1|Reported Event|BTX-A|BTX-A intralesional injection
272798|NCT00971425|B3|Baseline|Total|Total of all reporting groups
272799|NCT00971425|B2|Baseline|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272800|NCT00971425|B1|Baseline|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272851|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
272801|NCT00971425|P2|Participant Flow|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272802|NCT00971425|P1|Participant Flow|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272803|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272804|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272805|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272806|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272807|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272808|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272809|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272810|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272811|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272812|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272813|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272814|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272815|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272816|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272817|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272818|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272819|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272820|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272821|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272822|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272823|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272824|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272825|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272826|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272827|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272828|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272829|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272830|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272831|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272832|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272833|NCT00971425|E2|Reported Event|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
272834|NCT00971425|E1|Reported Event|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
272835|NCT00971295|B1|Baseline|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
272836|NCT00971295|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B:~Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate~850 mg metformin hydrochloride, 1200 mg ESL"
272837|NCT00971295|P1|Participant Flow|Treatment Sequence A|"Treatment Sequence A:~Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period~850 mg metformin hydrochloride, 1200 mg ESL"
272838|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
272839|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
272840|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
272841|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
272842|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
272843|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
272844|NCT00971295|E2|Reported Event|Metformin|Metformin HCl 850 mg
272845|NCT00971295|E1|Reported Event|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
272846|NCT00971282|B1|Baseline|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
272847|NCT00971282|P1|Participant Flow|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
272848|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
272849|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
272850|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
272853|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
272854|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
272855|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
272856|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
272857|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
272858|NCT00971282|E2|Reported Event|Differin Alone|intra-individual comparison
272859|NCT00971282|E1|Reported Event|Cetaphil + Differin|intra-individual comparison
272860|NCT00971243|B6|Baseline|Total|Total of all reporting groups
272861|NCT00971243|B5|Baseline|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272862|NCT00971243|B4|Baseline|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272863|NCT00971243|B3|Baseline|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272864|NCT00971243|B2|Baseline|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272865|NCT00971243|B1|Baseline|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272866|NCT00971243|P5|Participant Flow|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272867|NCT00971243|P4|Participant Flow|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272868|NCT00971243|P3|Participant Flow|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272869|NCT00971243|P2|Participant Flow|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272870|NCT00971243|P1|Participant Flow|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272871|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272872|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272873|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272874|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272875|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272876|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272877|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272878|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272879|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272880|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
272881|NCT00971243|E5|Reported Event|Placebo+Met|Placebo plus Metformin
272882|NCT00971243|E4|Reported Event|Teneli 40 mg+Met|Teneligliptin 40mg plus Metformin
272883|NCT00971243|E3|Reported Event|Teneli 20 mg+Met|Teneligliptin 20mg plus Metformin
272884|NCT00971243|E2|Reported Event|Teneli 10 mg+Met|Teneligliptin 10mg plus Metformin
272885|NCT00971243|E1|Reported Event|Teneli 5mg+Met|Teneligliptin 5mg plus Metformin
272886|NCT00971204|B1|Baseline|Treatment With HeartLight|Treatment of PAF with HeartLight System PVI ablation
272887|NCT00971204|P1|Participant Flow|Treatment With EAS-AC|"Treatment of PAF with EAS-AC~CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation"
272888|NCT00971204|O1|Outcome|Treatment With HeartLight|"Treatment of PAF with HeartLight System~CardioFocus HeartLight Endoscopic Ablation System: PVI ablation"
272889|NCT00971204|E1|Reported Event|Treatment With HeartLight|Treatment of PAF with HeartLight
272890|NCT00971048|B5|Baseline|Total|Total of all reporting groups
272891|NCT00971048|B4|Baseline|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272892|NCT00971048|B3|Baseline|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
272893|NCT00971048|B2|Baseline|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272894|NCT00971048|B1|Baseline|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
272895|NCT00971048|P4|Participant Flow|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272896|NCT00971048|P3|Participant Flow|HP828-101 Treating PU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
272897|NCT00971048|P2|Participant Flow|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU (3M Tegaderm Hydrogel)"
272898|NCT00971048|P1|Participant Flow|HP828-101 Treating DFU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
272899|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272900|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
272901|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272902|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
272903|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272904|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
272905|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272906|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
272907|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272908|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
272909|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272910|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
272911|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272912|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
272913|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272914|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
272915|NCT00971048|E4|Reported Event|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
272916|NCT00971048|E3|Reported Event|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
272917|NCT00971048|E2|Reported Event|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
272918|NCT00971048|E1|Reported Event|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
272919|NCT00970944|B3|Baseline|Total|Total of all reporting groups
272920|NCT00970944|B2|Baseline|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
272921|NCT00970944|B1|Baseline|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
272922|NCT00970944|P2|Participant Flow|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
272923|NCT00970944|P1|Participant Flow|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
272924|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
272925|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
272926|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the study drug.
272927|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
272928|NCT00970944|E2|Reported Event|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
272929|NCT00970944|E1|Reported Event|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
272930|NCT00970853|B3|Baseline|Total|Total of all reporting groups
272931|NCT00970853|B2|Baseline|MOM Program Home Visiting|Mixed professional support home visiting program.
272932|NCT00970853|B1|Baseline|Control|Control group
272933|NCT00970853|P2|Participant Flow|MOM Program Home Visiting|Mixed professional support home visiting program.
272934|NCT00970853|P1|Participant Flow|Control|Control group
272935|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272936|NCT00970853|O1|Outcome|Control|Control group
272937|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272939|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272940|NCT00970853|O1|Outcome|Control|Control group
272941|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272942|NCT00970853|O1|Outcome|Control|Control group
272943|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272944|NCT00970853|O1|Outcome|Control|Control group
272945|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272946|NCT00970853|O1|Outcome|Control|Control group
272947|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272948|NCT00970853|O1|Outcome|Control|Control group
272949|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272950|NCT00970853|O1|Outcome|Control|Control group
272951|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
272952|NCT00970853|O1|Outcome|Control|Control group
272953|NCT00970853|E2|Reported Event|MOM Program Home Visiting|Mixed professional support home visiting program.
272954|NCT00970853|E1|Reported Event|Control|Control group
272955|NCT00970814|B3|Baseline|Total|Total of all reporting groups
272956|NCT00970814|B2|Baseline|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272957|NCT00970814|B1|Baseline|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272958|NCT00970814|P2|Participant Flow|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272959|NCT00970814|P1|Participant Flow|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272960|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272961|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272962|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272963|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272964|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272965|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272966|NCT00970814|E2|Reported Event|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
272967|NCT00970814|E1|Reported Event|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
272968|NCT00970736|B1|Baseline|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272969|NCT00970736|P1|Participant Flow|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272970|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272971|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272972|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272973|NCT00970736|E1|Reported Event|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
272974|NCT00970684|B1|Baseline|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272975|NCT00970684|P1|Participant Flow|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272976|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272977|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272978|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272979|NCT00970684|E1|Reported Event|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
272980|NCT00970632|B4|Baseline|Total|Total of all reporting groups
272981|NCT00970632|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272982|NCT00970632|B2|Baseline|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272983|NCT00970632|B1|Baseline|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272984|NCT00970632|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272985|NCT00970632|P2|Participant Flow|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272986|NCT00970632|P1|Participant Flow|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272987|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272988|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272989|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272990|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272991|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272992|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272993|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272994|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272995|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272996|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
272997|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
272998|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
272999|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273000|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273001|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273002|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273003|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273004|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273005|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273006|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273007|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273008|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273009|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273010|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273011|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273012|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273013|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273014|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273015|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273016|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273017|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273018|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273019|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273020|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273021|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273022|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273023|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273024|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273025|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273026|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273027|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273028|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273029|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273030|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273031|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273032|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273033|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273034|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273035|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273036|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273037|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273038|NCT00970632|E3|Reported Event|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
273039|NCT00970632|E2|Reported Event|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
273040|NCT00970632|E1|Reported Event|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
273041|NCT00970606|B3|Baseline|Total|Total of all reporting groups
273042|NCT00970606|B2|Baseline|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
273043|NCT00970606|B1|Baseline|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
273044|NCT00970606|P2|Participant Flow|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
273045|NCT00970606|P1|Participant Flow|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
273046|NCT00970606|O2|Outcome|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
273047|NCT00970606|O1|Outcome|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
273048|NCT00970606|E2|Reported Event|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
273049|NCT00970606|E1|Reported Event|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
273050|NCT00970320|B6|Baseline|Total|Total of all reporting groups
280044|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
273051|NCT00970320|B5|Baseline|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
273052|NCT00970320|B4|Baseline|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273053|NCT00970320|B3|Baseline|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273054|NCT00970320|B2|Baseline|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273055|NCT00970320|B1|Baseline|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273056|NCT00970320|P5|Participant Flow|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
273057|NCT00970320|P4|Participant Flow|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273058|NCT00970320|P3|Participant Flow|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273059|NCT00970320|P2|Participant Flow|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273060|NCT00970320|P1|Participant Flow|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273061|NCT00970320|O5|Outcome|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
273062|NCT00970320|O4|Outcome|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273063|NCT00970320|O3|Outcome|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273064|NCT00970320|O2|Outcome|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273065|NCT00970320|O1|Outcome|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273066|NCT00970320|E5|Reported Event|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
273067|NCT00970320|E4|Reported Event|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273068|NCT00970320|E3|Reported Event|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273069|NCT00970320|E2|Reported Event|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
273070|NCT00970320|E1|Reported Event|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
273071|NCT00970294|B1|Baseline|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273072|NCT00970294|P1|Participant Flow|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273073|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273074|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273075|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273076|NCT00970294|E1|Reported Event|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
273077|NCT00970281|B3|Baseline|Total|Total of all reporting groups
273078|NCT00970281|B2|Baseline|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273079|NCT00970281|B1|Baseline|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273080|NCT00970281|P2|Participant Flow|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273081|NCT00970281|P1|Participant Flow|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273082|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273083|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273084|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273085|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273086|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273087|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273088|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273089|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273090|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273091|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273092|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273093|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273094|NCT00970281|E2|Reported Event|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273095|NCT00970281|E1|Reported Event|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
273096|NCT00970268|B3|Baseline|Total|Total of all reporting groups
273097|NCT00970268|B2|Baseline|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
273098|NCT00970268|B1|Baseline|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
273099|NCT00970268|P2|Participant Flow|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
273100|NCT00970268|P1|Participant Flow|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
273101|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
273102|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
273103|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
273104|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
273105|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
273106|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
273107|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
273108|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
273109|NCT00970268|E4|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
273110|NCT00970268|E3|Reported Event|Placebo to Aclidinium Bromide 400μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment
273111|NCT00970268|E2|Reported Event|Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg|Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.
273112|NCT00970268|E1|Reported Event|Placebo to Aclidinium Bromide 200 μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment
273113|NCT00970216|B1|Baseline|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
273114|NCT00970216|P1|Participant Flow|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
273115|NCT00970216|O1|Outcome|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
273116|NCT00970216|E1|Reported Event|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
273117|NCT00969878|B3|Baseline|Total|Total of all reporting groups
273118|NCT00969878|B2|Baseline|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
273119|NCT00969878|B1|Baseline|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
273120|NCT00969878|P2|Participant Flow|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
273121|NCT00969878|P1|Participant Flow|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
273122|NCT00969878|O2|Outcome|TA-CD Vaccination|
273123|NCT00969878|O1|Outcome|Placebo Injection|
273124|NCT00969878|O2|Outcome|TA-CD Vaccination|
273125|NCT00969878|O1|Outcome|Placebo Injection|
273126|NCT00969878|E2|Reported Event|TA-CD Vaccination|
273127|NCT00969878|E1|Reported Event|Placebo Injection|
273128|NCT00969709|B5|Baseline|Total|Total of all reporting groups
273129|NCT00969709|B4|Baseline|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273130|NCT00969709|B3|Baseline|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273131|NCT00969709|B2|Baseline|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273132|NCT00969709|B1|Baseline|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
273133|NCT00969709|P4|Participant Flow|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
273134|NCT00969709|P3|Participant Flow|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
273135|NCT00969709|P2|Participant Flow|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
273136|NCT00969709|P1|Participant Flow|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
273137|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273138|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273139|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273140|NCT00969709|O1|Outcome|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
273141|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
273142|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
273143|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
273144|NCT00969709|O1|Outcome|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
273145|NCT00969709|E4|Reported Event|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273146|NCT00969709|E3|Reported Event|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
273147|NCT00969709|E2|Reported Event|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks.
273148|NCT00969709|E1|Reported Event|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks.
273149|NCT00969618|B1|Baseline|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273150|NCT00969618|P1|Participant Flow|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
280045|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
273151|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273152|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273153|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273154|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273155|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273156|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273157|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273158|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273159|NCT00969618|E1|Reported Event|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
273160|NCT00969540|B3|Baseline|Total|Total of all reporting groups
273161|NCT00969540|B2|Baseline|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days.
273162|NCT00969540|B1|Baseline|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days.
273163|NCT00969540|P2|Participant Flow|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
273164|NCT00969540|P1|Participant Flow|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.
273165|NCT00969540|O2|Outcome|Sleep Latency With Active Mattress Cover|Sleep latency with active mattress cover (minutes).
273166|NCT00969540|O1|Outcome|Sleep Latency With Placebo Mattress Cover|Sleep latency with placebo mattress cover (minutes).
273167|NCT00969540|O2|Outcome|Sleep Efficiency With Active Mattress Cover|Sleep efficiency with active mattress cover.
273168|NCT00969540|O1|Outcome|Sleep Efficiency With Placebo Mattress Cover|Sleep efficiency with placebo mattress cover.
273169|NCT00969540|O2|Outcome|Nocturnal Awakenings With Active Mattress Cover|Number of nocturnal awakenings with active mattress cover.
273170|NCT00969540|O1|Outcome|Nocturnal Awakenings With Placebo Mattress Cover|Number of nocturnal awakenings with placebo mattress cover.
273171|NCT00969540|O2|Outcome|Total Sleep With Active Mattress Cover|Total sleep with active mattress cover (minutes).
273172|NCT00969540|O1|Outcome|Total Sleep With Placebo Mattress Cover|Total sleep with placebo mattress cover (minutes).
273173|NCT00969540|O2|Outcome|Nighttime Wake Time With Active Mattress Cover|Nighttime wake time after sleep onset with active mattress cover.
273174|NCT00969540|O1|Outcome|Nighttime Wake Time With Placebo Mattress Cover|Nighttime wake time after sleep onset with placebo mattress cover.
273175|NCT00969540|O4|Outcome|Mean CGI Sleep Scores With Active Mattress Cover.|Mean Clinical Global Impression sleep scores with active mattress cover.
273176|NCT00969540|O3|Outcome|Mean CGI Sleep Scores With Placebo Mattress Cover.|Mean Clinical Global Impression sleep scores with placebo mattress cover.
273177|NCT00969540|O2|Outcome|Mean CGI Pain Scores With Active Mattress Cover.|Mean Clinical Global Impression pain scores with active mattress cover.
273178|NCT00969540|O1|Outcome|Mean CGI Pain Scores With Placebo Mattress Cover.|Mean Clinical Global Impression pain scores with placebo mattress cover.
273179|NCT00969540|E2|Reported Event|Active Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
273180|NCT00969540|E1|Reported Event|Placebo Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period.
273181|NCT00969501|B1|Baseline|EUFLEXXA|ACTIVE CONTROL
273182|NCT00969501|P1|Participant Flow|EUFLEXXA|All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
273183|NCT00969501|O1|Outcome|EUFLEXXA|ACTIVE CONTROL
273184|NCT00969501|E1|Reported Event|EUFLEXXA|ACTIVE CONTROL
273185|NCT00969280|B3|Baseline|Total|Total of all reporting groups
273186|NCT00969280|B2|Baseline|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
273187|NCT00969280|B1|Baseline|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
273221|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
273222|NCT00969150|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
273223|NCT00969150|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
273224|NCT00968981|B4|Baseline|Total|Total of all reporting groups
273188|NCT00969280|P2|Participant Flow|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
273189|NCT00969280|P1|Participant Flow|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
273190|NCT00969280|O2|Outcome|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
273191|NCT00969280|O1|Outcome|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
273192|NCT00969280|E2|Reported Event|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
273193|NCT00969280|E1|Reported Event|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
273194|NCT00969228|B3|Baseline|Total|Total of all reporting groups
273195|NCT00969228|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273196|NCT00969228|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273197|NCT00969228|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273198|NCT00969228|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273199|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273200|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273201|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273202|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273203|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273204|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273205|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273206|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273207|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273208|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273209|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273210|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273211|NCT00969228|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
273212|NCT00969228|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
273213|NCT00969150|B3|Baseline|Total|Total of all reporting groups
273214|NCT00969150|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
273215|NCT00969150|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
273216|NCT00969150|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
273217|NCT00969150|P1|Participant Flow|Placebo|Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
273218|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
273219|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
273220|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
273225|NCT00968981|B3|Baseline|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273226|NCT00968981|B2|Baseline|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273227|NCT00968981|B1|Baseline|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273228|NCT00968981|P3|Participant Flow|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once weekly (QW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273229|NCT00968981|P2|Participant Flow|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule three times weekly (TIW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273230|NCT00968981|P1|Participant Flow|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273231|NCT00968981|O1|Outcome|GDC-0449 150 mg: All Participants|All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.
273232|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273233|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273234|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273235|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273236|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273237|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273238|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273239|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273240|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273241|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273242|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273243|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273244|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273245|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273246|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC­0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273247|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273248|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273249|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273250|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273251|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273252|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273376|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273253|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273254|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273255|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273256|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273257|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273258|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273259|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273260|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273261|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273262|NCT00968981|E3|Reported Event|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
273263|NCT00968981|E2|Reported Event|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
273264|NCT00968981|E1|Reported Event|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
273265|NCT00968890|B3|Baseline|Total|Total of all reporting groups
273266|NCT00968890|B2|Baseline|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273267|NCT00968890|B1|Baseline|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273268|NCT00968890|P2|Participant Flow|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273269|NCT00968890|P1|Participant Flow|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273270|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273271|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273272|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273273|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273274|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273275|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273276|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273277|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273278|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
280046|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
273279|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273280|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273281|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273282|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273283|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273284|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273285|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273286|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273287|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273288|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273289|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273290|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273291|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273292|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273293|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273294|NCT00968890|E2|Reported Event|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
273295|NCT00968890|E1|Reported Event|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
273296|NCT00968838|B3|Baseline|Total|Total of all reporting groups
273297|NCT00968838|B2|Baseline|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273298|NCT00968838|B1|Baseline|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273299|NCT00968838|P2|Participant Flow|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273300|NCT00968838|P1|Participant Flow|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273301|NCT00968838|O2|Outcome|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273302|NCT00968838|O1|Outcome|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273303|NCT00968838|E2|Reported Event|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273377|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
280047|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
273304|NCT00968838|E1|Reported Event|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
273305|NCT00968812|B4|Baseline|Total|Total of all reporting groups
273306|NCT00968812|B3|Baseline|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273307|NCT00968812|B2|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273308|NCT00968812|B1|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273309|NCT00968812|P3|Participant Flow|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273310|NCT00968812|P2|Participant Flow|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273311|NCT00968812|P1|Participant Flow|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273312|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273313|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273314|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273315|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273316|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273317|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273318|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273319|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273320|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273321|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
273322|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273323|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
273324|NCT00968812|E6|Reported Event|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
273325|NCT00968812|E5|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
273326|NCT00968812|E4|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
273327|NCT00968812|E3|Reported Event|Glimepiride: Baseline to Week 52|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
273328|NCT00968812|E2|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
273329|NCT00968812|E1|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
273330|NCT00968799|B1|Baseline|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273331|NCT00968799|P1|Participant Flow|HIPEC|"Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)~Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction).~To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l).~If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin).~Perfusion is performed with the open or Coliseum technique for 90 min."
273332|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273333|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273334|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273335|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273336|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273337|NCT00968799|E1|Reported Event|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
273338|NCT00968708|B3|Baseline|Total|Total of all reporting groups
273378|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273379|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273339|NCT00968708|B2|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
273340|NCT00968708|B1|Baseline|Placebo|Alogliptin placebo matching tablets, orally, once daily.
273341|NCT00968708|P2|Participant Flow|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
273342|NCT00968708|P1|Participant Flow|Placebo|Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
273343|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
273344|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
273345|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
273346|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
273347|NCT00968708|E2|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
273348|NCT00968708|E1|Reported Event|Placebo|Alogliptin placebo matching tablets, orally, once daily.
273349|NCT00968669|B5|Baseline|Total|Total of all reporting groups
273350|NCT00968669|B4|Baseline|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273351|NCT00968669|B3|Baseline|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273352|NCT00968669|B2|Baseline|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273353|NCT00968669|B1|Baseline|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273354|NCT00968669|P4|Participant Flow|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273355|NCT00968669|P3|Participant Flow|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273356|NCT00968669|P2|Participant Flow|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273357|NCT00968669|P1|Participant Flow|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273358|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273359|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273360|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273361|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273362|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273363|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273364|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273365|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273366|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273367|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273368|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273369|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273370|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273371|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273372|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273373|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273374|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273375|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
274360|NCT00965562|E3|Reported Event|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
273380|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273381|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273382|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273383|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273384|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273385|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273386|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273387|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273388|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273389|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273390|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273391|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273392|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273393|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273394|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273395|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273396|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273397|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273398|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273399|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273400|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273401|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273402|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273403|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273404|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273405|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273406|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273407|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273408|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273409|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273410|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273411|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273412|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273413|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273414|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273415|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273416|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273417|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273418|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273419|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273420|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273421|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273422|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273423|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273424|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273425|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273426|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273427|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273428|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
280048|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
273429|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273430|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273431|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273432|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273433|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273434|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273435|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273436|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273437|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273438|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273439|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273440|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273441|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273442|NCT00968669|E4|Reported Event|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273443|NCT00968669|E3|Reported Event|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273444|NCT00968669|E2|Reported Event|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
273445|NCT00968669|E1|Reported Event|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
273446|NCT00968617|B1|Baseline|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273447|NCT00968617|P1|Participant Flow|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273448|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273449|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273450|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273451|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273452|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273453|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273454|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273455|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273456|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
273457|NCT00968617|E1|Reported Event|MK-2578|
273458|NCT00968201|B3|Baseline|Total|Total of all reporting groups
273459|NCT00968201|B2|Baseline|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273460|NCT00968201|B1|Baseline|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273461|NCT00968201|P3|Participant Flow|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
273462|NCT00968201|P2|Participant Flow|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273463|NCT00968201|P1|Participant Flow|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273464|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273465|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273466|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273558|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273467|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273468|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273469|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273470|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273471|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273472|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273473|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273474|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273475|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273476|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273477|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273478|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273479|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273525|NCT00968149|P1|Participant Flow|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
275607|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
273480|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273481|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273482|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273483|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273484|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273485|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273486|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273487|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273488|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273489|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273490|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273491|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273492|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273624|NCT00967447|P1|Participant Flow|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273493|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273494|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
273495|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273496|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273497|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273498|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273499|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273500|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273501|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273502|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273503|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273504|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273505|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273506|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273507|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273508|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273509|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273510|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273511|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273512|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273513|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273514|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273515|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273516|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
273517|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273518|NCT00968201|E3|Reported Event|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
273519|NCT00968201|E2|Reported Event|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
273520|NCT00968201|E1|Reported Event|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
273521|NCT00968149|B3|Baseline|Total|Total of all reporting groups
273522|NCT00968149|B2|Baseline|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273523|NCT00968149|B1|Baseline|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273524|NCT00968149|P2|Participant Flow|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273625|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273526|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273527|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273528|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273529|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273530|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273531|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273532|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273533|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273534|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273535|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273536|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273537|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273538|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273539|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273540|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273541|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273542|NCT00968149|E2|Reported Event|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
273543|NCT00968149|E1|Reported Event|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
273544|NCT00968071|B1|Baseline|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
273545|NCT00968071|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
273546|NCT00968071|O1|Outcome|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
273547|NCT00968071|E1|Reported Event|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
273548|NCT00968032|B1|Baseline|Nit-Occlud® PFO|
273549|NCT00968032|P1|Participant Flow|Nit-Occlud® PFO Implantation Group|Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
273550|NCT00968032|O1|Outcome|Nit-Occlud® PFO|
273551|NCT00968032|E1|Reported Event|Nit-Occlud® PFO|
273552|NCT00968019|B1|Baseline|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273553|NCT00968019|P1|Participant Flow|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273554|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273555|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273556|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273557|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
275608|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
273559|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273560|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273561|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273562|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273563|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273564|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273565|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273566|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273567|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273568|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273569|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273570|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273571|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273572|NCT00968019|E1|Reported Event|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
273573|NCT00967993|B1|Baseline|KRX-0502|All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
273574|NCT00967993|P1|Participant Flow|KRX-0502|"All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
273575|NCT00967993|O1|Outcome|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
273576|NCT00967993|E1|Reported Event|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
273577|NCT00967694|B1|Baseline|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
273578|NCT00967694|P1|Participant Flow|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
273579|NCT00967694|O1|Outcome|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
273580|NCT00967694|E1|Reported Event|Nitrous Oxide Administration|20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
273581|NCT00967668|B4|Baseline|Total|Total of all reporting groups
273582|NCT00967668|B3|Baseline|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
273583|NCT00967668|B2|Baseline|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273626|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273627|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273628|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273629|NCT00967447|E1|Reported Event|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
273630|NCT00967330|B3|Baseline|Total|Total of all reporting groups
273744|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273584|NCT00967668|B1|Baseline|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273585|NCT00967668|P3|Participant Flow|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
273586|NCT00967668|P2|Participant Flow|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273587|NCT00967668|P1|Participant Flow|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273588|NCT00967668|O3|Outcome|Arm 3|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
273589|NCT00967668|O2|Outcome|Arm 2|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273590|NCT00967668|O1|Outcome|Arm 1|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273591|NCT00967668|O3|Outcome|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
273592|NCT00967668|O2|Outcome|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273745|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273593|NCT00967668|O1|Outcome|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273594|NCT00967668|E3|Reported Event|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
273595|NCT00967668|E2|Reported Event|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273596|NCT00967668|E1|Reported Event|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
273597|NCT00967551|B3|Baseline|Total|Total of all reporting groups
273598|NCT00967551|B2|Baseline|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
273599|NCT00967551|B1|Baseline|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
273600|NCT00967551|P2|Participant Flow|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
273601|NCT00967551|P1|Participant Flow|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
273602|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
273603|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
273604|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
273605|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
273606|NCT00967551|E2|Reported Event|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
273607|NCT00967551|E1|Reported Event|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
273608|NCT00967486|B3|Baseline|Total|Total of all reporting groups
273609|NCT00967486|B2|Baseline|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
273610|NCT00967486|B1|Baseline|Routine Shunt|routine methods of CEA
273611|NCT00967486|P2|Participant Flow|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
273612|NCT00967486|P1|Participant Flow|Routine Shunt|Routine method of CEA
273613|NCT00967486|O2|Outcome|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
273614|NCT00967486|O1|Outcome|Routine Shunt|routine methods of CEA
273615|NCT00967486|E2|Reported Event|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
273616|NCT00967486|E1|Reported Event|Routine Shunt|routine methods of CEA
273617|NCT00967473|B1|Baseline|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273618|NCT00967473|P1|Participant Flow|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273619|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273620|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273621|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273622|NCT00967473|E1|Reported Event|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
273623|NCT00967447|B1|Baseline|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
280049|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
273631|NCT00967330|B2|Baseline|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273632|NCT00967330|B1|Baseline|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273633|NCT00967330|P2|Participant Flow|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273634|NCT00967330|P1|Participant Flow|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273635|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273636|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273637|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273638|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273639|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273692|NCT00967226|E2|Reported Event|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 6 months or less"
273693|NCT00967226|E1|Reported Event|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.5 mg/kg p.o. QID 6 months or less"
273640|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273641|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273642|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273643|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273644|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273645|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273646|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273647|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273648|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273694|NCT00967044|B1|Baseline|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
273746|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273649|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273650|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273651|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273652|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273653|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273654|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273655|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273656|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273657|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
273695|NCT00967044|P1|Participant Flow|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
273747|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273658|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273659|NCT00967330|E2|Reported Event|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible.
273660|NCT00967330|E1|Reported Event|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
273661|NCT00967226|B3|Baseline|Total|Total of all reporting groups
273662|NCT00967226|B2|Baseline|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
273663|NCT00967226|B1|Baseline|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)"
273664|NCT00967226|P2|Participant Flow|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID 4-6 months"
273665|NCT00967226|P1|Participant Flow|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months"
273666|NCT00967226|O2|Outcome|Constitutional AEs Prednisolone|Number of Participants experiencing Constitutional AEs
273667|NCT00967226|O1|Outcome|Constitutional AEs Propranolol|Number of Participants experiencing Constitutional AEs
273668|NCT00967226|O2|Outcome|Vascular AEs Prednisolone|Number of participants experiencing Vascular AEs
273669|NCT00967226|O1|Outcome|Vascular AEs Propranolol|Number of participants experiencing Vascular AEs
273670|NCT00967226|O2|Outcome|Metabolic/Laboratory AEs Prednisolone|Number of participants experiencing Metabolic or Laboratory AEs in each study arm.
273671|NCT00967226|O1|Outcome|Metabolic/Laboratory AEs Propranolol|Number of participants experiencing Metabolic or Laboratory AEs.
273672|NCT00967226|O2|Outcome|Infectious AEs Prednisolone|Number of participants experiencing Infectious AEs
273673|NCT00967226|O1|Outcome|Infectious AEs Propranolol|Number of participants experiencing Infectious AEs
273674|NCT00967226|O2|Outcome|Gastrointestinal AEs Prednisolone|Number of Participants experiencing Gastrointestinal AEs
273675|NCT00967226|O1|Outcome|Gastrointestinal AEs Propranolol|Number of Participants experiencing Gastrointestinal AEs
273676|NCT00967226|O2|Outcome|Endocrinologic AEs Prednisolone|Number of participants experiencing Endocrinologic AEs.
273677|NCT00967226|O1|Outcome|Endocrine AEs Propranolol|Number of participants experiencing Endocrinologic AEs.
273678|NCT00967226|O2|Outcome|Dermatologic AEs Prednisolone|Number of participants experiencing Dermatologic AEs
273679|NCT00967226|O1|Outcome|Dermatologic AEs Propranolol|Number of participants experiencing Dermatologic AEs
273680|NCT00967226|O2|Outcome|Allergy/Immunology Events Prednisolone|Adverse events in allergy/immunology in prednisolone treated participants
273681|NCT00967226|O1|Outcome|Allergy/Immunology Events Propranolol|Adverse events in allergy/immunology in propranolol treated participants
273682|NCT00967226|O2|Outcome|Pulmonary/Respiratory AEs Prednisolone|Number of participants experiencing pulmonary/respiratory AEs
273683|NCT00967226|O1|Outcome|Pulmonary/Respiratory AEs Propranolol|Number of participants experiencing pulmonary/respiratory AEs
273684|NCT00967226|O2|Outcome|Growth/Development AEs Prednisolone|Number of participants experiencing Growth/Development AEs
273685|NCT00967226|O1|Outcome|Growth/Developoment AEs Propranolol|Number of participants experiencing Growth/Development AEs
273686|NCT00967226|O2|Outcome|Number of Serious Adverse Events in Prednisolone|Serious adverse events in prednisolone treated participants
273687|NCT00967226|O1|Outcome|Number of Serious Adverse Events in Propranolol|Serious adverse events in propranolol treated participants.
273688|NCT00967226|O2|Outcome|Overall Number of Adverse Events in Prednisolone|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
273689|NCT00967226|O1|Outcome|Overall Number of Adverse Events in Propranolol|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
273690|NCT00967226|O2|Outcome|Prednisolone|"A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
273691|NCT00967226|O1|Outcome|Propranolol|A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)
273743|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273696|NCT00967044|O1|Outcome|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
273697|NCT00967044|E1|Reported Event|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
273698|NCT00967018|B1|Baseline|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273699|NCT00967018|P1|Participant Flow|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273700|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273701|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273702|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273703|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273704|NCT00967018|E1|Reported Event|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
273705|NCT00966992|B3|Baseline|Total|Total of all reporting groups
273706|NCT00966992|B2|Baseline|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
273707|NCT00966992|B1|Baseline|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273708|NCT00966992|P2|Participant Flow|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
273709|NCT00966992|P1|Participant Flow|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273710|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273711|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273712|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273713|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273714|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273715|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273716|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273717|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273718|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273719|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273720|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273721|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273722|NCT00966992|E2|Reported Event|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
273723|NCT00966992|E1|Reported Event|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
273724|NCT00966953|B5|Baseline|Total|Total of all reporting groups
273725|NCT00966953|B4|Baseline|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
273726|NCT00966953|B3|Baseline|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
273727|NCT00966953|B2|Baseline|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
273728|NCT00966953|B1|Baseline|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
273729|NCT00966953|P4|Participant Flow|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
273730|NCT00966953|P3|Participant Flow|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
273731|NCT00966953|P2|Participant Flow|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
273732|NCT00966953|P1|Participant Flow|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
273733|NCT00966953|O4|Outcome|Herbal Extract Toothpaste|Fluoride/Magnolol extract toothpaste
273734|NCT00966953|O3|Outcome|Herbal Extract Toothpaste|Fluoride/Honokiol extract toothpaste
273735|NCT00966953|O2|Outcome|Total/Whitening|Control toothpaste
273736|NCT00966953|O1|Outcome|Fluoride Only|Control toothopaste
273737|NCT00966940|B3|Baseline|Total|Total of all reporting groups
273738|NCT00966940|B2|Baseline|Tafluprost-to-travoprost|Tafluprost, then travoprost
273739|NCT00966940|B1|Baseline|Travoprost-to-tafluprost|Travoprost, then tafluprost
273740|NCT00966940|P2|Participant Flow|Tafluprost-to-travoprost|Tafluprost, then travoprost
273741|NCT00966940|P1|Participant Flow|Travoprost-to-tafluprost|Travoprost, then tafluprost
273742|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
275609|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
273748|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273749|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273750|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273751|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273752|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273753|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273754|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273755|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273756|NCT00966940|E2|Reported Event|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273757|NCT00966940|E1|Reported Event|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
273758|NCT00966875|B10|Baseline|Total|Total of all reporting groups
273759|NCT00966875|B9|Baseline|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273760|NCT00966875|B8|Baseline|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273761|NCT00966875|B7|Baseline|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273762|NCT00966875|B6|Baseline|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273763|NCT00966875|B5|Baseline|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273764|NCT00966875|B4|Baseline|30 mg LY2439821 [bDMARD-naive Population|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273765|NCT00966875|B3|Baseline|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273766|NCT00966875|B2|Baseline|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273767|NCT00966875|B1|Baseline|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273768|NCT00966875|P9|Participant Flow|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273769|NCT00966875|P8|Participant Flow|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273770|NCT00966875|P7|Participant Flow|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
273771|NCT00966875|P6|Participant Flow|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273772|NCT00966875|P5|Participant Flow|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273773|NCT00966875|P4|Participant Flow|30 mg LY2439821 [bDMARD-naive Population]|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273774|NCT00966875|P3|Participant Flow|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273775|NCT00966875|P2|Participant Flow|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273776|NCT00966875|P1|Participant Flow|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
273777|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273778|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
280050|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
273779|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273780|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273781|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273782|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273783|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273784|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273785|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273786|NCT00966875|O8|Outcome|Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)|160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
273787|NCT00966875|O7|Outcome|Part A: 180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273788|NCT00966875|O6|Outcome|Part A: 80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273789|NCT00966875|O5|Outcome|Part A: 180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273790|NCT00966875|O4|Outcome|Part A: 80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273791|NCT00966875|O3|Outcome|Part A: 30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273792|NCT00966875|O2|Outcome|Part A: 10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273793|NCT00966875|O1|Outcome|Part A: 3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273794|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273795|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273796|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273797|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273798|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273799|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273800|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273801|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273802|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273803|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273804|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273805|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273806|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273807|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274264|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
273808|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273809|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273810|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273811|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273812|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273813|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273814|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273815|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273816|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273817|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273818|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273819|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273820|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273821|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273822|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273823|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273824|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273825|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273826|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273827|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273828|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273829|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273830|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273831|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273832|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273833|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273930|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273834|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273835|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273836|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273837|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273838|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273839|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273840|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273841|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273842|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273843|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273844|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273845|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273846|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273847|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273848|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273849|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273850|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273851|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273852|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273853|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273854|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273855|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273856|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273857|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273858|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273859|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273860|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273861|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273862|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273863|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273864|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273865|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273866|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274355|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
273867|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273868|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273869|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273870|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273871|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273872|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273873|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273874|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273875|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273876|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273877|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273878|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273879|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273880|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273881|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273882|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273883|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273884|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273885|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273886|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273887|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273888|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273889|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273890|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273891|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273892|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273893|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273894|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273895|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273896|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273897|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273898|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
280051|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
273899|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273900|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273901|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273902|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273903|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273904|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273905|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273906|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273907|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273908|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273909|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273910|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273911|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273912|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273913|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273914|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population])|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273915|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273916|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273917|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273918|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273919|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273920|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273921|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273922|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273923|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273924|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273925|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273926|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273927|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273928|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273929|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273931|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273932|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273933|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273934|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273935|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273936|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273937|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273938|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273939|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273940|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273941|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273942|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273943|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273944|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273945|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273946|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273947|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273948|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273949|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273950|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273951|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273952|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273953|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273954|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273955|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273956|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273957|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273958|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273959|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273960|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273961|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273962|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274061|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273963|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273964|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273965|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273966|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273967|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273968|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273969|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273970|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273971|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273972|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273973|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273974|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273975|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273976|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273977|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273978|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273979|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273980|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273981|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273982|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273983|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273984|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273985|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273986|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273987|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273988|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273989|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273990|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273991|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
273992|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273993|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273994|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273995|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274123|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
273996|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273997|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273998|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
273999|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274000|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274001|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274002|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274003|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274004|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274005|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274006|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274007|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274008|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274009|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274010|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274011|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274012|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274013|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274014|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274015|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274016|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274017|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274018|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274019|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274020|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274021|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274022|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274023|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274024|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274025|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274026|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274027|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274028|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274185|NCT00966186|E2|Reported Event|Rotational Technique|
274029|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274030|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274031|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274032|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274033|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274034|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274035|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274036|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274037|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274038|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274039|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274040|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274041|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274042|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274043|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274044|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274045|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274046|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821(TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274047|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821(TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274048|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274049|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274050|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821(bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274051|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821(bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274052|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821(bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274053|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821(bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274054|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274055|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274056|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274057|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274058|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274059|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274060|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274062|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274063|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274064|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274065|NCT00966875|O1|Outcome|3 mg to 180 mg (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274066|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274067|NCT00966875|O3|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274068|NCT00966875|O2|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274069|NCT00966875|O1|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274070|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274071|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274072|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274073|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274074|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274075|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
274076|NCT00966875|E18|Reported Event|Placebo/160 mg LY2439821 (TNFa-IR Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274077|NCT00966875|E17|Reported Event|180 mg/160 mg LY2439821 (TNFa-IR Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274078|NCT00966875|E16|Reported Event|80 mg/160 mg LY2439821 (TNFa-IR Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274079|NCT00966875|E15|Reported Event|Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274080|NCT00966875|E14|Reported Event|180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274081|NCT00966875|E13|Reported Event|80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274082|NCT00966875|E12|Reported Event|30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274083|NCT00966875|E11|Reported Event|10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274084|NCT00966875|E10|Reported Event|3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274085|NCT00966875|E9|Reported Event|Placebo (TNFa-IR Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274086|NCT00966875|E8|Reported Event|180 mg LY2439821 (TNFa-IR Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274087|NCT00966875|E7|Reported Event|80 mg LY2439821 (TNFa-IR Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274088|NCT00966875|E6|Reported Event|Placebo (bDMARD-naive Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274089|NCT00966875|E5|Reported Event|180 mg LY2439821(bDMARD-naive Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274090|NCT00966875|E4|Reported Event|80 mg LY2439821 (bDMARD-naive Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274091|NCT00966875|E3|Reported Event|30 mg LY2439821 (bDMARD-naive Population) Part A|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274092|NCT00966875|E2|Reported Event|10 mg LY2439821 (bDMARD-naive Population) Part A|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274093|NCT00966875|E1|Reported Event|3 mg LY2439821 (bDMARD-naive Population) Part A|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
274094|NCT00966641|B1|Baseline|All Study Participants|All study participants who were enrolled in the study.
274095|NCT00966641|P2|Participant Flow|Naproxen First, Then PL3100|"First Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen~(after 7-14 day washout period)~Second Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)"
274096|NCT00966641|P1|Participant Flow|PL3100 First, Then Naproxen|"First Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)~(after 7-14 day washout period)~Second Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen"
274097|NCT00966641|O2|Outcome|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
274098|NCT00966641|O1|Outcome|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
274099|NCT00966641|E2|Reported Event|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
274100|NCT00966641|E1|Reported Event|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
274101|NCT00966550|B3|Baseline|Total|Total of all reporting groups
274102|NCT00966550|B2|Baseline|Non-tomato First Then Tomato|"Non-tomato high fat test meal~Non-tomato test meal: non-tomato with High fat test meal"
274103|NCT00966550|B1|Baseline|Tomato First Then Non-tomato|"tomato High fat test meal~Tomato products: tomato with High fat test meal"
274104|NCT00966550|P2|Participant Flow|Non-tomato First Then Tomato|Non-tomato :High fat meal with non-tomato
274105|NCT00966550|P1|Participant Flow|Tomato First Then Non-tomato|Tomato :High fat meal with tomato
274106|NCT00966550|O2|Outcome|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
274107|NCT00966550|O1|Outcome|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
274108|NCT00966550|E2|Reported Event|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
274109|NCT00966550|E1|Reported Event|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
274110|NCT00966446|B4|Baseline|Total|Total of all reporting groups
274111|NCT00966446|B3|Baseline|No Intervention|Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).
274112|NCT00966446|B2|Baseline|Supervised Decolonization|This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.
274113|NCT00966446|B1|Baseline|Unsupervised Decolonization|"This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group."
274114|NCT00966446|P3|Participant Flow|No Intervention|Households do not undergo active MRSA decolonization protocol
274115|NCT00966446|P2|Participant Flow|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
274116|NCT00966446|P1|Participant Flow|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
274117|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
274118|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
274119|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
274120|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
274121|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
274122|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
274124|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
274125|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
274126|NCT00966446|E3|Reported Event|No Intervention|Households do not undergo active MRSA decolonization protocol
274127|NCT00966446|E2|Reported Event|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
274128|NCT00966446|E1|Reported Event|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
274129|NCT00966277|B3|Baseline|Total|Total of all reporting groups
274130|NCT00966277|B2|Baseline|Group 2: Control|No Dalteparin study drug.
274131|NCT00966277|B1|Baseline|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
274132|NCT00966277|P2|Participant Flow|Group 2: Control|No Dalteparin study drug (primary prophylaxis).
274133|NCT00966277|P1|Participant Flow|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
274134|NCT00966277|O2|Outcome|Group 2: Control|No Dalteparin study drug.
274135|NCT00966277|O1|Outcome|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
274136|NCT00966277|E2|Reported Event|Group 2: Control|No Dalteparin study drug.
274137|NCT00966277|E1|Reported Event|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
274138|NCT00966264|B3|Baseline|Total|Total of all reporting groups
274139|NCT00966264|B2|Baseline|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
274140|NCT00966264|B1|Baseline|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
274141|NCT00966264|P2|Participant Flow|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
274142|NCT00966264|P1|Participant Flow|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
274143|NCT00966264|O2|Outcome|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
274144|NCT00966264|O1|Outcome|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
274145|NCT00966264|E2|Reported Event|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
274146|NCT00966264|E1|Reported Event|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
274147|NCT00966238|B7|Baseline|Total|Total of all reporting groups
274148|NCT00966238|B6|Baseline|8.0 µg i.m.|
274149|NCT00966238|B5|Baseline|5.0 µg i.m.|
274150|NCT00966238|B4|Baseline|3.0 µg i.m.|
274151|NCT00966238|B3|Baseline|2.0 µg i.m.|
274152|NCT00966238|B2|Baseline|1.0 µg i.m.|
274153|NCT00966238|B1|Baseline|0.5 µg i.m.|
274154|NCT00966238|P6|Participant Flow|8.0 µg i.m.|
274155|NCT00966238|P5|Participant Flow|5.0 µg i.m.|
274156|NCT00966238|P4|Participant Flow|3.0 µg i.m.|
274157|NCT00966238|P3|Participant Flow|2.0 µg i.m.|
274158|NCT00966238|P2|Participant Flow|1.0 µg i.m.|
274159|NCT00966238|P1|Participant Flow|0.5 µg i.m.|
274160|NCT00966238|O6|Outcome|8.0 µg i.m.|
274161|NCT00966238|O5|Outcome|5.0 µg i.m.|
274162|NCT00966238|O4|Outcome|3.0 µg i.m.|
274163|NCT00966238|O3|Outcome|2.0 µg i.m.|
274164|NCT00966238|O2|Outcome|1.0 µg i.m.|
274165|NCT00966238|O1|Outcome|0.5 µg i.m.|
274166|NCT00966238|O6|Outcome|8.0 µg i.m.|
274167|NCT00966238|O5|Outcome|5.0 µg i.m.|
274168|NCT00966238|O4|Outcome|3.0 µg i.m.|
274169|NCT00966238|O3|Outcome|2.0 µg i.m.|
274170|NCT00966238|O2|Outcome|1.0 µg i.m.|
274171|NCT00966238|O1|Outcome|0.5 µg i.m.|
274172|NCT00966238|E6|Reported Event|8.0 µg i.m.|
274173|NCT00966238|E5|Reported Event|5.0 µg i.m.|
274174|NCT00966238|E4|Reported Event|3.0 µg i.m.|
274175|NCT00966238|E3|Reported Event|2.0 µg i.m.|
274176|NCT00966238|E2|Reported Event|1.0 µg i.m.|
274177|NCT00966238|E1|Reported Event|0.5 µg i.m.|
274178|NCT00966186|B3|Baseline|Total|Total of all reporting groups
274179|NCT00966186|B2|Baseline|Rotational Technique|
274180|NCT00966186|B1|Baseline|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
274181|NCT00966186|P2|Participant Flow|Rotational Technique|
274182|NCT00966186|P1|Participant Flow|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
274183|NCT00966186|O2|Outcome|Rotational Technique|
274184|NCT00966186|O1|Outcome|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
274186|NCT00966186|E1|Reported Event|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
274187|NCT00965848|B1|Baseline|Entire Study Population|
274188|NCT00965848|P3|Participant Flow|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274189|NCT00965848|P2|Participant Flow|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274190|NCT00965848|P1|Participant Flow|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274191|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274192|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274193|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274194|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274195|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274196|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274197|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274198|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274199|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274200|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274201|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274202|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274203|NCT00965848|E3|Reported Event|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
274204|NCT00965848|E2|Reported Event|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
274205|NCT00965848|E1|Reported Event|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
274206|NCT00965757|B3|Baseline|Total|Total of all reporting groups
274207|NCT00965757|B2|Baseline|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274208|NCT00965757|B1|Baseline|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
274209|NCT00965757|P4|Participant Flow|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274210|NCT00965757|P3|Participant Flow|T-614 (Extension, 29-52 Weeks)|T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
274211|NCT00965757|P2|Participant Flow|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274212|NCT00965757|P1|Participant Flow|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
274213|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274214|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274215|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274216|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274217|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274218|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274219|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274220|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274221|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274222|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274223|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274224|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274225|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274226|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274227|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274228|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274229|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274230|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274231|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274232|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274233|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274234|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274235|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274236|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274237|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274238|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274239|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274240|NCT00965757|E3|Reported Event|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
274241|NCT00965757|E2|Reported Event|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
274242|NCT00965757|E1|Reported Event|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
274243|NCT00965731|B3|Baseline|Total|Total of all reporting groups
274244|NCT00965731|B2|Baseline|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274245|NCT00965731|B1|Baseline|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274246|NCT00965731|P2|Participant Flow|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274247|NCT00965731|P1|Participant Flow|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274248|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274249|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274250|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274251|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
274252|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274253|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274254|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274255|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274256|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274257|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274258|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274259|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274260|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274261|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274262|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274263|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274265|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274266|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274267|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274268|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274269|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274270|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
274271|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274272|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274273|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274274|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274275|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274276|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274277|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274278|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274279|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274280|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274281|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274282|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274283|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274284|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274285|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274286|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274356|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274357|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274287|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274288|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274289|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274290|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274291|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274292|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274293|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274294|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274295|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274296|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274297|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274298|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274299|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274300|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274301|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274302|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274303|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274304|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
274305|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
274358|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274359|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274306|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274307|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274308|NCT00965731|E2|Reported Event|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274309|NCT00965731|E1|Reported Event|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
274310|NCT00965718|B1|Baseline|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274311|NCT00965718|P1|Participant Flow|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274312|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274313|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274314|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274315|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274316|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274317|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274318|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274319|NCT00965718|E1|Reported Event|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
274320|NCT00965562|B4|Baseline|Total|Total of all reporting groups
274321|NCT00965562|B3|Baseline|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274322|NCT00965562|B2|Baseline|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274323|NCT00965562|B1|Baseline|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274324|NCT00965562|P3|Participant Flow|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274325|NCT00965562|P2|Participant Flow|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274326|NCT00965562|P1|Participant Flow|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274327|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274328|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274329|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274330|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274331|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274332|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274333|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274334|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274335|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274336|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274337|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274338|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274339|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274340|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274341|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274342|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274343|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274344|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274345|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274346|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274347|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274348|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
274349|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274350|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274351|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
274352|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274353|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274354|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
274361|NCT00965562|E2|Reported Event|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
274362|NCT00965562|E1|Reported Event|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
274363|NCT00965523|B1|Baseline|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
274364|NCT00965523|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
274365|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
274366|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
274367|NCT00965523|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
274368|NCT00965497|B1|Baseline|Open-label, Single Arm|All patients will receive the intervention
274369|NCT00965497|P1|Participant Flow|Open-label, Single Arm|All patients will receive the intervention
274370|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
274371|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
274372|NCT00965497|E1|Reported Event|Open-label, Single Arm|All patients will receive the intervention
274373|NCT00965484|B1|Baseline|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274374|NCT00965484|P1|Participant Flow|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274375|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274376|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274377|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274378|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274379|NCT00965484|E1|Reported Event|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
274380|NCT00965458|B3|Baseline|Total|Total of all reporting groups
274381|NCT00965458|B2|Baseline|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
274382|NCT00965458|B1|Baseline|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
274383|NCT00965458|P2|Participant Flow|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274384|NCT00965458|P1|Participant Flow|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274385|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274386|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274387|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274388|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274389|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274390|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274391|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274392|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274393|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274394|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
274395|NCT00965458|O2|Outcome|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
274518|NCT00964886|O1|Outcome|Arm 1 + Arm 3|Factor all participants assigned at baseline to receive desipramine hydrochloride
274396|NCT00965458|O1|Outcome|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
274397|NCT00965458|E2|Reported Event|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
274398|NCT00965458|E1|Reported Event|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
274399|NCT00965341|B3|Baseline|Total|Total of all reporting groups
274400|NCT00965341|B2|Baseline|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
274401|NCT00965341|B1|Baseline|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
274402|NCT00965341|P2|Participant Flow|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
274403|NCT00965341|P1|Participant Flow|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
274404|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
274405|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
274406|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
274407|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
274408|NCT00965341|E2|Reported Event|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
274409|NCT00965341|E1|Reported Event|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
274410|NCT00965250|B3|Baseline|Total|Total of all reporting groups
274411|NCT00965250|B2|Baseline|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274412|NCT00965250|B1|Baseline|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274413|NCT00965250|P2|Participant Flow|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274414|NCT00965250|P1|Participant Flow|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274415|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274416|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274417|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274418|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274419|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274420|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274421|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274422|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274423|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274424|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
275116|NCT00963430|B2|Baseline|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
274425|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274426|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274427|NCT00965250|O1|Outcome|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
274428|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274429|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
274430|NCT00965250|E1|Reported Event|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
274431|NCT00965237|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
274432|NCT00965237|P2|Participant Flow|Single Vision CL + Reading Glasses / Multifocal CL|Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
274433|NCT00965237|P1|Participant Flow|Multifocal CL / Single Vision CL+ Reading Glasses|Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
274434|NCT00965237|O2|Outcome|Lotrafilcon B Single Vision Contact Lens + Reading Glasses|Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
274435|NCT00965237|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use
274436|NCT00965237|E2|Reported Event|Single Vision Contact Lens|Commercially marketed lotrafilcon B single vision contact lenses
274437|NCT00965237|E1|Reported Event|Multifocal Contact Lens|Commercially marketed lotrafilcon B multifocal contact lenses
274438|NCT00965185|B3|Baseline|Total|Total of all reporting groups
274439|NCT00965185|B2|Baseline|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274440|NCT00965185|B1|Baseline|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274441|NCT00965185|P2|Participant Flow|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274442|NCT00965185|P1|Participant Flow|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274443|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274444|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274445|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274446|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274447|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274448|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274449|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274450|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274451|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274452|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274453|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274454|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274455|NCT00965185|E2|Reported Event|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
274456|NCT00965185|E1|Reported Event|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
274457|NCT00965146|B1|Baseline|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
274458|NCT00965146|P1|Participant Flow|Scorpio® CR Device|All subjects were implanted with the Scorpio® CR Total Knee System Study Device
274459|NCT00965146|O1|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
274460|NCT00965146|E1|Reported Event|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
274461|NCT00965094|B3|Baseline|Total|Total of all reporting groups
274462|NCT00965094|B2|Baseline|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274463|NCT00965094|B1|Baseline|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274464|NCT00965094|P2|Participant Flow|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274465|NCT00965094|P1|Participant Flow|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274466|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274467|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274468|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274469|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274470|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274471|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274472|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274473|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274474|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274475|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274476|NCT00965094|E2|Reported Event|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
274477|NCT00965094|E1|Reported Event|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
274478|NCT00965081|B3|Baseline|Total|Total of all reporting groups
274479|NCT00965081|B2|Baseline|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274480|NCT00965081|B1|Baseline|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274481|NCT00965081|P2|Participant Flow|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274482|NCT00965081|P1|Participant Flow|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274483|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274484|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274485|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274486|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274487|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274488|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274489|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274567|NCT00964496|P2|Participant Flow|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274490|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274491|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274492|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274493|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274494|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274495|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274496|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274497|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274498|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274499|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274500|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
274501|NCT00965081|E3|Reported Event|Duloxetine 60 mg|Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
274502|NCT00965081|E2|Reported Event|Duloxetine 30 mg|Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
274503|NCT00965081|E1|Reported Event|Placebo|Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
274504|NCT00964886|B5|Baseline|Total|Total of all reporting groups
274505|NCT00964886|B4|Baseline|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
274506|NCT00964886|B3|Baseline|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274507|NCT00964886|B2|Baseline|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274508|NCT00964886|B1|Baseline|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
274509|NCT00964886|P4|Participant Flow|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
274510|NCT00964886|P3|Participant Flow|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274511|NCT00964886|P2|Participant Flow|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274512|NCT00964886|P1|Participant Flow|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
274513|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor all participants assigned at baseline not to receive cognitive behavioral therapy
274514|NCT00964886|O1|Outcome|Arm 2 + Arm 3|Factor all participants assigned at baseline to receive cognitive behavioral therapy
274515|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor no cognitive behavioral therapy
274516|NCT00964886|O1|Outcome|Arm 2 + Arm 3|"Factor cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274517|NCT00964886|O2|Outcome|Arm 2 + Arm 4|Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
274519|NCT00964886|O2|Outcome|Arm 2 + Arm 4|"Factor anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
274520|NCT00964886|O1|Outcome|Arm 1 + Arm 3|"Factor desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
274521|NCT00964886|E4|Reported Event|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
274522|NCT00964886|E3|Reported Event|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274523|NCT00964886|E2|Reported Event|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
274524|NCT00964886|E1|Reported Event|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
274525|NCT00964860|B3|Baseline|Total|Total of all reporting groups
274526|NCT00964860|B2|Baseline|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
274527|NCT00964860|B1|Baseline|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
274528|NCT00964860|P2|Participant Flow|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
274529|NCT00964860|P1|Participant Flow|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
274530|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
274531|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
274532|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
274533|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
274534|NCT00964860|E2|Reported Event|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
274535|NCT00964860|E1|Reported Event|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
274536|NCT00964795|B1|Baseline|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274537|NCT00964795|P1|Participant Flow|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274538|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274539|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274540|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274568|NCT00964496|P1|Participant Flow|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
275610|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
274541|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274542|NCT00964795|E1|Reported Event|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
274543|NCT00964743|B1|Baseline|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274544|NCT00964743|P1|Participant Flow|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274545|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274546|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274547|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274548|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274549|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274550|NCT00964743|E1|Reported Event|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
274551|NCT00964548|B3|Baseline|Total|Total of all reporting groups
274552|NCT00964548|B2|Baseline|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274553|NCT00964548|B1|Baseline|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274554|NCT00964548|P2|Participant Flow|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274555|NCT00964548|P1|Participant Flow|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274556|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274557|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274558|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274559|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274560|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274561|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274562|NCT00964548|E2|Reported Event|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
274563|NCT00964548|E1|Reported Event|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
274564|NCT00964496|B3|Baseline|Total|Total of all reporting groups
274565|NCT00964496|B2|Baseline|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274566|NCT00964496|B1|Baseline|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
275117|NCT00963430|B1|Baseline|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
274569|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274570|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274571|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274572|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274573|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274574|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274575|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274576|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274577|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274578|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274579|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274580|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274581|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274582|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274583|NCT00964496|E2|Reported Event|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274584|NCT00964496|E1|Reported Event|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
274585|NCT00964444|B1|Baseline|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
274586|NCT00964444|P1|Participant Flow|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
274587|NCT00964444|O1|Outcome|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
274588|NCT00964444|E1|Reported Event|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
274589|NCT00964431|B5|Baseline|Total|Total of all reporting groups
274590|NCT00964431|B4|Baseline|Placebo|
274591|NCT00964431|B3|Baseline|Celecoxib 400 mg|
274592|NCT00964431|B2|Baseline|Indomethacin Test (Upper Dose)|Single dose
274593|NCT00964431|B1|Baseline|Indomethacin Test (Lower Dose)|
274594|NCT00964431|P4|Participant Flow|Placebo|
274595|NCT00964431|P3|Participant Flow|Celecoxib 400 mg|
274596|NCT00964431|P2|Participant Flow|Indomethacin Test (Upper Dose)|Single dose
274597|NCT00964431|P1|Participant Flow|Indomethacin Test (Lower Dose)|
274598|NCT00964431|O4|Outcome|Placebo|
274599|NCT00964431|O3|Outcome|Celecoxib 400 mg|
274600|NCT00964431|O2|Outcome|Indomethacin Test (Upper Dose)|40-mg
274601|NCT00964431|O1|Outcome|Indomethacin Test (Lower Dose)|20-mg
274602|NCT00964431|E4|Reported Event|Placebo|
274603|NCT00964431|E3|Reported Event|Celecoxib 400 mg|
274604|NCT00964431|E2|Reported Event|Indomethacin Test (Upper Dose)|Single dose
274605|NCT00964431|E1|Reported Event|Indomethacin Test (Lower Dose)|
274606|NCT00963235|B1|Baseline|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274607|NCT00963235|P1|Participant Flow|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274608|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274790|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274609|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274610|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274611|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274612|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274613|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274614|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274615|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274616|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274617|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274618|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274619|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274620|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
274621|NCT00963235|E4|Reported Event|13vPnC (After Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
274622|NCT00963235|E3|Reported Event|13vPnC (After Dose 3 and Before Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
274623|NCT00963235|E2|Reported Event|13vPnC (After Dose 2 and Before Dose 3)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
274624|NCT00963235|E1|Reported Event|13vPnC (After Dose 1 and Before Dose 2)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
274625|NCT00964366|B3|Baseline|Total|Total of all reporting groups
274626|NCT00964366|B2|Baseline|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274627|NCT00964366|B1|Baseline|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274628|NCT00964366|P2|Participant Flow|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274629|NCT00964366|P1|Participant Flow|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274630|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274732|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274631|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274632|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274633|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274634|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274635|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274636|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274637|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274638|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274639|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274640|NCT00964366|E2|Reported Event|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274641|NCT00964366|E1|Reported Event|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
274642|NCT00964223|B1|Baseline|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274643|NCT00964223|P1|Participant Flow|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274644|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274645|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274646|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274647|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274648|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274649|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274650|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274651|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274652|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274653|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274654|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274655|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274656|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274657|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274658|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274659|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274660|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274661|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274662|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274663|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274664|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274665|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274666|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
280052|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
274667|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274668|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274669|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274670|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274671|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274672|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274673|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274674|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274675|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274676|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274677|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274678|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274679|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274680|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274681|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274682|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274683|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274684|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
280053|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
274685|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274686|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274687|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274688|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274689|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274690|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274691|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274692|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274693|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274694|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274695|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274696|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274697|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274698|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274699|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274700|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274701|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274702|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
275611|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
274703|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274704|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274705|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274706|NCT00964223|E1|Reported Event|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
274707|NCT00964119|B1|Baseline|Single Cohort Observational|
274708|NCT00964119|P1|Participant Flow|Single Cohort Obervational|
274709|NCT00964119|O1|Outcome|Single Cohort Observational|
274710|NCT00964119|E1|Reported Event|Single Cohort Observational|
274711|NCT00963937|B4|Baseline|Total|Total of all reporting groups
274712|NCT00963937|B3|Baseline|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274713|NCT00963937|B2|Baseline|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274714|NCT00963937|B1|Baseline|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274715|NCT00963937|P3|Participant Flow|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274716|NCT00963937|P2|Participant Flow|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274717|NCT00963937|P1|Participant Flow|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274718|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274719|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274720|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274721|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274722|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274723|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274724|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274725|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274726|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274727|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274728|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274729|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274730|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274731|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
275118|NCT00963430|P2|Participant Flow|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
274733|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274734|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274735|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274736|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274737|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274738|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274739|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274740|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274741|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274742|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274743|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274744|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274745|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274746|NCT00963937|O2|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274747|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274748|NCT00963937|E4|Reported Event|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
274749|NCT00963937|E3|Reported Event|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274750|NCT00963937|E2|Reported Event|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
274751|NCT00963937|E1|Reported Event|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
274752|NCT00963924|B3|Baseline|Total|Total of all reporting groups
274753|NCT00963924|B2|Baseline|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274754|NCT00963924|B1|Baseline|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274755|NCT00963924|P2|Participant Flow|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274756|NCT00963924|P1|Participant Flow|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274757|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274758|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274759|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274760|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274761|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274762|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274763|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274764|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274765|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274766|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274767|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274768|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
274769|NCT00963924|E2|Reported Event|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274770|NCT00963924|E1|Reported Event|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
274771|NCT00963872|B3|Baseline|Total|Total of all reporting groups
274772|NCT00963872|B2|Baseline|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274773|NCT00963872|B1|Baseline|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274774|NCT00963872|P2|Participant Flow|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274775|NCT00963872|P1|Participant Flow|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274776|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274777|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274778|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274779|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274780|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274781|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274782|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274783|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274784|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274785|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274786|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274787|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274788|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274789|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
275612|NCT00962585|E4|Reported Event|Placebo|Placebo treatment arm
274791|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274792|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274793|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274794|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274795|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274796|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274797|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274798|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274799|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274800|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274801|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274802|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274803|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274804|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274805|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274806|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274807|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274808|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274809|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274810|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274811|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274812|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274813|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274814|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274815|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274816|NCT00963872|E2|Reported Event|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
274817|NCT00963872|E1|Reported Event|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
274818|NCT00963859|B1|Baseline|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
274819|NCT00963859|P1|Participant Flow|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
274820|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
274821|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
274822|NCT00963859|E1|Reported Event|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
274823|NCT00963820|B1|Baseline|Overall Study|Safety Population
274824|NCT00963820|P12|Participant Flow|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274825|NCT00963820|P11|Participant Flow|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
275302|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
274826|NCT00963820|P10|Participant Flow|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274827|NCT00963820|P9|Participant Flow|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274828|NCT00963820|P8|Participant Flow|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274829|NCT00963820|P7|Participant Flow|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274830|NCT00963820|P6|Participant Flow|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274831|NCT00963820|P5|Participant Flow|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274832|NCT00963820|P4|Participant Flow|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274833|NCT00963820|P3|Participant Flow|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274834|NCT00963820|P2|Participant Flow|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274835|NCT00963820|P1|Participant Flow|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274836|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274837|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274838|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274839|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274840|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274841|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274842|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274843|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274844|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274845|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274846|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274847|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274871|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
280054|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
274848|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274849|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274850|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274851|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274852|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274853|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274854|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274855|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274856|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274857|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274858|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274859|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274860|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274861|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274862|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274863|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274864|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274865|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274866|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274867|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274868|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274869|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274870|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274872|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274873|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274874|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274875|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274876|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274877|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274878|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274879|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274880|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274881|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274882|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274883|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274884|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274885|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274886|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274887|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274888|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274889|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274890|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274891|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274892|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274893|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274894|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274895|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274896|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274897|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274898|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274899|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274900|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274901|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274902|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274903|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274904|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274905|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274906|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274907|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274908|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274909|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274910|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274911|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274912|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274913|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274914|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274915|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274916|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274917|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274918|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274919|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274920|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274921|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274922|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274923|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274924|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274925|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274926|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274927|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274928|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274929|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274930|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274931|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274932|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274933|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274934|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274935|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274936|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274937|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274938|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274939|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274940|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274941|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274942|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274943|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274944|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274945|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274946|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274947|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274948|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274949|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274950|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274951|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274952|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274953|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274954|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274955|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274956|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274957|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274958|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274959|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274960|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274961|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274962|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274963|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274964|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274965|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274966|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274967|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274968|NCT00963820|E2|Reported Event|Expansion Cohorts|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274969|NCT00963820|E1|Reported Event|Dose Escalation Cohorts|Ixazomib citrate, 0.24 to 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
274970|NCT00963677|B3|Baseline|Total|Total of all reporting groups
274971|NCT00963677|B2|Baseline|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
274972|NCT00963677|B1|Baseline|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
274973|NCT00963677|P2|Participant Flow|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
274974|NCT00963677|P1|Participant Flow|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
274975|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
274976|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
274977|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
274978|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
274979|NCT00963677|E2|Reported Event|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
274980|NCT00963677|E1|Reported Event|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
274981|NCT00963638|B3|Baseline|Total|Total of all reporting groups
274982|NCT00963638|B2|Baseline|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
274983|NCT00963638|B1|Baseline|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
274984|NCT00963638|P2|Participant Flow|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
274985|NCT00963638|P1|Participant Flow|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
274986|NCT00963638|O2|Outcome|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
274987|NCT00963638|O1|Outcome|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
274988|NCT00963638|E2|Reported Event|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
274989|NCT00963638|E1|Reported Event|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
274990|NCT00963599|B5|Baseline|Total|Total of all reporting groups
274991|NCT00963599|B4|Baseline|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
274992|NCT00963599|B3|Baseline|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
274993|NCT00963599|B2|Baseline|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
274994|NCT00963599|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
274995|NCT00963599|P4|Participant Flow|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
274996|NCT00963599|P3|Participant Flow|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275613|NCT00962585|E3|Reported Event|S-equol 150 mg BID|300 mg total daily dose of S-equol
274997|NCT00963599|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
274998|NCT00963599|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
274999|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275000|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275001|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275002|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275003|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275004|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275005|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275006|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275007|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275008|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275009|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275010|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275011|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275012|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275013|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275014|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275015|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275016|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275017|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275018|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275019|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275020|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275021|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275022|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275023|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275024|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275025|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275026|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275027|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275028|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275029|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275030|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275614|NCT00962585|E2|Reported Event|S-equol 50 mg BID|100 mg total daily dose of S-equol
275031|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275032|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275033|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275034|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275035|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275036|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275037|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275038|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275039|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275040|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275041|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275042|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275043|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275044|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275045|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275046|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275047|NCT00963599|E4|Reported Event|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
275048|NCT00963599|E3|Reported Event|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275049|NCT00963599|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275050|NCT00963599|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
275051|NCT00963560|B4|Baseline|Total|Total of all reporting groups
275052|NCT00963560|B3|Baseline|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
275053|NCT00963560|B2|Baseline|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
275054|NCT00963560|B1|Baseline|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
275055|NCT00963560|P3|Participant Flow|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
275056|NCT00963560|P2|Participant Flow|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
275057|NCT00963560|P1|Participant Flow|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
275058|NCT00963560|O3|Outcome|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
275059|NCT00963560|O2|Outcome|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
275060|NCT00963560|O1|Outcome|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
275061|NCT00963560|E3|Reported Event|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
275062|NCT00963560|E2|Reported Event|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
275063|NCT00963560|E1|Reported Event|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
275064|NCT00963508|B3|Baseline|Total|Total of all reporting groups
275065|NCT00963508|B2|Baseline|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
275066|NCT00963508|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
275067|NCT00963508|P2|Participant Flow|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
275068|NCT00963508|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
275069|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
275114|NCT00963469|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275070|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
275071|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
275072|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
275073|NCT00963508|E2|Reported Event|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
275074|NCT00963508|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
275075|NCT00963482|B3|Baseline|Total|Total of all reporting groups
275076|NCT00963482|B2|Baseline|Control Group|Autogenic training
275077|NCT00963482|B1|Baseline|Intervention Group|Cognitive-behavioural smoking cessation program
275078|NCT00963482|P2|Participant Flow|Control Group|Autogenic training
275079|NCT00963482|P1|Participant Flow|Intervention Group|Cognitive-behavioural smoking cessation program
275080|NCT00963482|O2|Outcome|Control Group|Autogenic training
275081|NCT00963482|O1|Outcome|Intervention Group|Cognitive-behavioural smoking cessation program
275082|NCT00963482|E2|Reported Event|Control Group|Autogenic training
275083|NCT00963482|E1|Reported Event|Intervention Group|Cognitive-behavioural smoking cessation program
275084|NCT00963469|B4|Baseline|Total|Total of all reporting groups
275085|NCT00963469|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275086|NCT00963469|B2|Baseline|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275087|NCT00963469|B1|Baseline|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275088|NCT00963469|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275089|NCT00963469|P2|Participant Flow|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275090|NCT00963469|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275091|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275092|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275093|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275094|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275095|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275096|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275097|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275098|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275099|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275100|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275101|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275102|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275103|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275104|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275105|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275106|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275107|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275108|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275109|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275110|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275111|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275112|NCT00963469|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
275113|NCT00963469|E2|Reported Event|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
275115|NCT00963430|B3|Baseline|Total|Total of all reporting groups
275119|NCT00963430|P1|Participant Flow|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275120|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275121|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275122|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275123|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275124|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275125|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275126|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275127|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275128|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275129|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275130|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275131|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275132|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275133|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275134|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275135|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275136|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275137|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275138|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275139|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275140|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275141|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275142|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275143|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275144|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275145|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275146|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275147|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275148|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275149|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275150|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275151|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275152|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275153|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275154|NCT00963430|E2|Reported Event|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275155|NCT00963430|E1|Reported Event|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
275156|NCT00963157|B6|Baseline|Total|Total of all reporting groups
275157|NCT00963157|B5|Baseline|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275158|NCT00963157|B4|Baseline|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275159|NCT00963157|B3|Baseline|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275160|NCT00963157|B2|Baseline|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275161|NCT00963157|B1|Baseline|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275162|NCT00963157|P5|Participant Flow|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275163|NCT00963157|P4|Participant Flow|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275615|NCT00962585|E1|Reported Event|S-equol 10 mg BID|20 mg total daily dose of S-equol
275164|NCT00963157|P3|Participant Flow|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275165|NCT00963157|P2|Participant Flow|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275166|NCT00963157|P1|Participant Flow|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275167|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275168|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275169|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275170|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275171|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275172|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275173|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275174|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275175|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275176|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275177|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275178|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275179|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275180|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275181|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275182|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275183|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275184|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275185|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275186|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275187|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275188|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275189|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275190|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275191|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275192|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275193|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275194|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275195|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275196|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275197|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275198|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275199|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275200|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275201|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275202|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275203|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275204|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275205|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275206|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275207|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275208|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275209|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275210|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275211|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275212|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275213|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275214|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275215|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275216|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275217|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275218|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275219|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275220|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275221|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275222|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275223|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275224|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275225|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275226|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275227|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275228|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275229|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275230|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275231|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275232|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275233|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275234|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275235|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275236|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275237|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275238|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275239|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275240|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275241|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275242|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275243|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275244|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275245|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275246|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275247|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275248|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275249|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275250|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275251|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275252|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275253|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275254|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275255|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275616|NCT00962208|B3|Baseline|Total|Total of all reporting groups
275256|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275257|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275258|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275259|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275260|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275261|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275262|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275263|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275264|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275265|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275266|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275267|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275268|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275269|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275270|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275271|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275272|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275273|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275274|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275275|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275276|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275277|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275278|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275279|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275280|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275281|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275282|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275283|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275284|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275285|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275286|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275287|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275288|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275289|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275290|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275291|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275292|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275293|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275294|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275295|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275296|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275297|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275298|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275299|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275300|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275301|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
280055|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
275303|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275304|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275305|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275306|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275307|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275308|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275309|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275310|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275311|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275312|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275313|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275314|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275315|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275316|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275317|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275318|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275319|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275320|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275321|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275322|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275323|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275324|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275325|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275326|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275327|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275328|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275329|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275330|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275331|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275332|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275333|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275334|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275335|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275336|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275337|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275338|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275339|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275340|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275341|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275342|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275343|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275344|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275345|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275346|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275347|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275348|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
280056|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
275349|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275350|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275351|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275352|NCT00963157|E5|Reported Event|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275353|NCT00963157|E4|Reported Event|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275354|NCT00963157|E3|Reported Event|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
275355|NCT00963157|E2|Reported Event|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275356|NCT00963157|E1|Reported Event|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
275357|NCT00962871|B5|Baseline|Total|Total of all reporting groups
275358|NCT00962871|B4|Baseline|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
275359|NCT00962871|B3|Baseline|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275360|NCT00962871|B2|Baseline|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275361|NCT00962871|B1|Baseline|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275362|NCT00962871|P4|Participant Flow|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
275363|NCT00962871|P3|Participant Flow|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275364|NCT00962871|P2|Participant Flow|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275365|NCT00962871|P1|Participant Flow|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275366|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
275367|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275368|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275369|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275370|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
275371|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275372|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275373|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275374|NCT00962871|E4|Reported Event|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
275375|NCT00962871|E3|Reported Event|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275376|NCT00962871|E2|Reported Event|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275377|NCT00962871|E1|Reported Event|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
275378|NCT00962780|B3|Baseline|Total|Total of all reporting groups
275379|NCT00962780|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275402|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275380|NCT00962780|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275381|NCT00962780|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275382|NCT00962780|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275383|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275384|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275385|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275386|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275387|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275388|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275389|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275390|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275391|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275392|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275393|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275394|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275395|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275396|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275397|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275398|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275399|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275400|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275401|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275403|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275404|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275405|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275406|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275407|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275408|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275409|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275410|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275411|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275412|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275413|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275414|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275415|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275416|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275417|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275418|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275419|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275420|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275421|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275422|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275423|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275424|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275425|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275426|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275427|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275428|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275429|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275430|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275431|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275432|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275433|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275434|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275435|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275436|NCT00962780|O1|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
275437|NCT00962780|E6|Reported Event|Follow-up|Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
275438|NCT00962780|E5|Reported Event|23vPS Dose|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
275439|NCT00962780|E4|Reported Event|13vPnC Dose 3|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
275440|NCT00962780|E3|Reported Event|13vPnC Dose 2|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
275441|NCT00962780|E2|Reported Event|13vPnC Dose 1|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
275442|NCT00962780|E1|Reported Event|Prior 13vPnC Dose 1|Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
275443|NCT00962754|B3|Baseline|Total|Total of all reporting groups
275444|NCT00962754|B2|Baseline|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance data (fluid balance chart is blinded)
275445|NCT00962754|B1|Baseline|Physician Insight Fluid Balance|physician has insight in the fluid balance data
275446|NCT00962754|P2|Participant Flow|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance chart
275447|NCT00962754|P1|Participant Flow|Physician Insight Fluid Balance|Physician has insight in the fluid balance chart
275448|NCT00962754|O2|Outcome|Physician no Insight Fluid Balance Chart|physician has no insight in the fluid balance data (masked)
275449|NCT00962754|O1|Outcome|Physician Insight Fluid Balance|Physician has insight (full access to) in the fluid balance chart data
275450|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|Physician has insight in (full access to) the fluid balance chart data
275451|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in the fluid balance chart data (masked)
275452|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|physician has insight in (full access to) the fluid balance chart data
275453|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in fluid balance chart, ie the fluid balance chart is masked
275454|NCT00962754|E2|Reported Event|Physician no Insight Fluid Balance Chart|Physician has no insight in the fluid balance chart data (masked)
275455|NCT00962754|E1|Reported Event|Physician Insight Fluid Balance|physician has insight in (full access to) the fluid balance chart data
275456|NCT00962741|B1|Baseline|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275457|NCT00962741|P1|Participant Flow|Etanercept|Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275458|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275459|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275460|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275461|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275462|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275463|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275464|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275465|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275466|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275467|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275468|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275469|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275470|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275471|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275472|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275473|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275474|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275475|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275476|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275477|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275478|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275479|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275480|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275481|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275482|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275483|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275484|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275485|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275486|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275487|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275488|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275489|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275490|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275491|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275492|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275493|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275494|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275495|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275496|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275497|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275498|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275499|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275500|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275501|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275502|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275503|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275504|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275505|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275506|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275507|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275508|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275509|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275510|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275511|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275512|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275513|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275514|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275515|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275516|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275517|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275518|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275519|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275520|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275521|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275522|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275523|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275524|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275525|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275526|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275527|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275528|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275529|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275530|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275531|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275532|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275533|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275534|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275535|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275536|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275537|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275538|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275539|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275540|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275541|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275542|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275543|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275544|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275545|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275546|NCT00962741|E1|Reported Event|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
275547|NCT00962650|B1|Baseline|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
275548|NCT00962650|P1|Participant Flow|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
275549|NCT00962650|O1|Outcome|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
275550|NCT00962650|E1|Reported Event|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
275551|NCT00962585|B5|Baseline|Total|Total of all reporting groups
275552|NCT00962585|B4|Baseline|Placebo|Placebo treatment arm
275553|NCT00962585|B3|Baseline|S-equol 150 mg BID|300 mg total daily dose of S-equol
275554|NCT00962585|B2|Baseline|S-equol 50 mg BID|100 mg total daily dose of S-equol
275555|NCT00962585|B1|Baseline|S-equol 10 mg BID|20 mg total daily dose of S-equol
275556|NCT00962585|P4|Participant Flow|Placebo|Placebo treatment arm
275557|NCT00962585|P3|Participant Flow|S-equol 150 mg BID|300 mg total daily dose of S-equol
275558|NCT00962585|P2|Participant Flow|S-equol 50 mg BID|100 mg total daily dose of S-equol
275559|NCT00962585|P1|Participant Flow|S-equol 10 mg BID|20 mg total daily dose of S-equol
275560|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
275561|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
275562|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275563|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275564|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275565|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275566|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
275567|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
275568|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275569|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275570|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275571|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275572|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275573|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275574|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275575|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275576|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275577|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275578|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275579|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275580|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275581|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275582|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275583|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275584|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275585|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275586|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275587|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275588|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275589|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275590|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275591|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275592|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275593|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275594|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275595|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275596|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275597|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275598|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275599|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275600|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275601|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275602|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275603|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
275604|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
275605|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
275606|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
275617|NCT00962208|B2|Baseline|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
275618|NCT00962208|B1|Baseline|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
275619|NCT00962208|P2|Participant Flow|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
275620|NCT00962208|P1|Participant Flow|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
275621|NCT00962208|O2|Outcome|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
275622|NCT00962208|O1|Outcome|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
275623|NCT00962208|E2|Reported Event|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
275624|NCT00962208|E1|Reported Event|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
275625|NCT00962104|B3|Baseline|Total|Total of all reporting groups
275626|NCT00962104|B2|Baseline|Placebo|Taken by mouth, once daily for 10 weeks.
275627|NCT00962104|B1|Baseline|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275628|NCT00962104|P2|Participant Flow|Placebo|Taken by mouth, once daily for 10 weeks.
275629|NCT00962104|P1|Participant Flow|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275630|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275631|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275632|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275633|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275634|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275635|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275636|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275637|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275638|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275639|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275640|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275641|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275642|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275643|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275644|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275645|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275646|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275647|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275648|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275649|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275650|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
275651|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275652|NCT00962104|E2|Reported Event|Placebo|Taken by mouth, once daily for 10 weeks.
275653|NCT00962104|E1|Reported Event|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
275654|NCT00962065|B4|Baseline|Total|Total of all reporting groups
275655|NCT00962065|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake for 28 days
275656|NCT00962065|B2|Baseline|High Dose|A high dose of LX4211; daily oral intake for 28 days
275657|NCT00962065|B1|Baseline|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275658|NCT00962065|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 28 days
275659|NCT00962065|P2|Participant Flow|High Dose|A high dose of LX4211; daily oral intake for 28 days
275660|NCT00962065|P1|Participant Flow|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275661|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275662|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275663|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275664|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275665|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275666|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275667|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275668|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275669|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275670|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275671|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275672|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275673|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275674|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275675|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275676|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
275677|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
275678|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275679|NCT00962065|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 28 days
275680|NCT00962065|E2|Reported Event|High Dose|A high dose of LX4211; daily oral intake for 28 days
275681|NCT00962065|E1|Reported Event|Low Dose|A low dose of LX4211; daily oral intake for 28 days
275682|NCT00962013|B1|Baseline|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275683|NCT00962013|P1|Participant Flow|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275684|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275685|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275686|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275687|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275688|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275689|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275690|NCT00962013|E1|Reported Event|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
275691|NCT00962000|B1|Baseline|All Study Participants|All subjects who participated in the study.
275692|NCT00962000|P2|Participant Flow|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
275693|NCT00962000|P1|Participant Flow|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
275694|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
275695|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
275696|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
275697|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
275698|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
275699|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
275700|NCT00962000|E2|Reported Event|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
275701|NCT00962000|E1|Reported Event|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
275702|NCT00961896|B4|Baseline|Total|Total of all reporting groups
275703|NCT00961896|B3|Baseline|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
275704|NCT00961896|B2|Baseline|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
275705|NCT00961896|B1|Baseline|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275706|NCT00961896|P3|Participant Flow|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
275707|NCT00961896|P2|Participant Flow|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
275708|NCT00961896|P1|Participant Flow|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275709|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
275710|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275711|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
275712|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
275713|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
275714|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275715|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
275716|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
275717|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
275718|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275719|NCT00961896|O4|Outcome|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
275720|NCT00961896|O3|Outcome|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
275721|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
275722|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
275723|NCT00961896|E3|Reported Event|0.75% LDE225 [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
275724|NCT00961896|E2|Reported Event|0.25% LDE225 [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
275725|NCT00961896|E1|Reported Event|All Part I Participants|Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
275726|NCT00961805|B3|Baseline|Total|Total of all reporting groups
275727|NCT00961805|B2|Baseline|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
275728|NCT00961805|B1|Baseline|Group Control|The waiting list
275729|NCT00961805|P2|Participant Flow|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275730|NCT00961805|P1|Participant Flow|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275776|NCT00961649|P3|Participant Flow|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
280057|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
275731|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275732|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275733|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275734|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275735|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275736|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275737|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275738|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275739|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275740|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275741|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275742|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275743|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275744|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275745|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275746|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
280058|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
275747|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275748|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275749|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275750|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275751|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275752|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275753|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275754|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275755|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
275756|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
275757|NCT00961662|B4|Baseline|Total|Total of all reporting groups
275758|NCT00961662|B3|Baseline|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275759|NCT00961662|B2|Baseline|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
275760|NCT00961662|B1|Baseline|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275761|NCT00961662|P3|Participant Flow|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275762|NCT00961662|P2|Participant Flow|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
275763|NCT00961662|P1|Participant Flow|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275764|NCT00961662|O3|Outcome|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275765|NCT00961662|O2|Outcome|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
275766|NCT00961662|O1|Outcome|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275767|NCT00961662|E3|Reported Event|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275768|NCT00961662|E2|Reported Event|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
275769|NCT00961662|E1|Reported Event|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
275770|NCT00961649|B5|Baseline|Total|Total of all reporting groups
275771|NCT00961649|B4|Baseline|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275772|NCT00961649|B3|Baseline|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275773|NCT00961649|B2|Baseline|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275774|NCT00961649|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275775|NCT00961649|P4|Participant Flow|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275777|NCT00961649|P2|Participant Flow|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275778|NCT00961649|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275779|NCT00961649|O2|Outcome|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275780|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275781|NCT00961649|O3|Outcome|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275782|NCT00961649|O2|Outcome|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275783|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275784|NCT00961649|E4|Reported Event|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275785|NCT00961649|E3|Reported Event|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275786|NCT00961649|E2|Reported Event|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275787|NCT00961649|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
275788|NCT00961636|B4|Baseline|Total|Total of all reporting groups
275789|NCT00961636|B3|Baseline|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
275790|NCT00961636|B2|Baseline|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
275791|NCT00961636|B1|Baseline|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
275792|NCT00961636|P3|Participant Flow|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
275793|NCT00961636|P2|Participant Flow|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
275794|NCT00961636|P1|Participant Flow|ERN/LRPT|One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
275795|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
275796|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
275797|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
275798|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
275799|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
275800|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
275801|NCT00961636|E3|Reported Event|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
275802|NCT00961636|E2|Reported Event|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
275803|NCT00961636|E1|Reported Event|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
275804|NCT00961532|B1|Baseline|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
275805|NCT00961532|P1|Participant Flow|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
275806|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
275807|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
275808|NCT00961532|E1|Reported Event|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
275809|NCT00961441|B3|Baseline|Total|Total of all reporting groups
275810|NCT00961441|B2|Baseline|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275811|NCT00961441|B1|Baseline|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275812|NCT00961441|P2|Participant Flow|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275813|NCT00961441|P1|Participant Flow|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275814|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275815|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275816|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275817|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275818|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275819|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275820|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275821|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275822|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275823|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275824|NCT00961441|E2|Reported Event|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275825|NCT00961441|E1|Reported Event|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
275826|NCT00961415|B3|Baseline|Total|Total of all reporting groups
275827|NCT00961415|B2|Baseline|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275828|NCT00961415|B1|Baseline|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275829|NCT00961415|P3|Participant Flow|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275830|NCT00961415|P2|Participant Flow|Bevacizumab Maintenance Treatment (Trt) Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275831|NCT00961415|P1|Participant Flow|Induction Treatment Phase|Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
275832|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275833|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy
275834|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm...
275835|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
275836|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
275837|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
276791|NCT00959907|B2|Baseline|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
275838|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.
275839|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
275840|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275841|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275842|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275843|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275844|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275845|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275846|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275847|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275848|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275849|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
275850|NCT00961415|E3|Reported Event|Maintenance Treatment Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
275851|NCT00961415|E2|Reported Event|Maintenance Treatment Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
275852|NCT00961415|E1|Reported Event|No Maintenance Treatment|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
275853|NCT00961402|B3|Baseline|Total|Total of all reporting groups
275854|NCT00961402|B2|Baseline|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275855|NCT00961402|B1|Baseline|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275892|NCT00961298|B1|Baseline|Treatment Arm|every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275856|NCT00961402|P2|Participant Flow|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275857|NCT00961402|P1|Participant Flow|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275858|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275859|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275860|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275861|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275862|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275863|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275864|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275865|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275866|NCT00961402|E2|Reported Event|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
275867|NCT00961402|E1|Reported Event|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
275868|NCT00961350|B3|Baseline|Total|Total of all reporting groups
275869|NCT00961350|B2|Baseline|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275870|NCT00961350|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275871|NCT00961350|P2|Participant Flow|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275872|NCT00961350|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275873|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275874|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275875|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275876|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275877|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275878|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275879|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275880|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275881|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275882|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275883|NCT00961350|E2|Reported Event|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
275884|NCT00961350|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
275885|NCT00961311|B1|Baseline|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275886|NCT00961311|P1|Participant Flow|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275887|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275888|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275889|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275890|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
275891|NCT00961311|E1|Reported Event|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
276792|NCT00959907|B1|Baseline|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
275893|NCT00961298|P1|Participant Flow|Treatment Arm|Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275894|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275895|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275896|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275897|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275898|NCT00961298|E1|Reported Event|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
275899|NCT00961259|B1|Baseline|Fenofibric Acid - Treatments A, B and C|All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
275900|NCT00961259|P3|Participant Flow|Treatment Sequence CAB|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
275901|NCT00961259|P2|Participant Flow|Treatment Sequence BCA|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
275902|NCT00961259|P1|Participant Flow|Treatment Sequence ABC|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
275903|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
275904|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275905|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275906|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275907|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
275908|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275909|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275910|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275911|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
275912|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275913|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275914|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275915|NCT00961259|E3|Reported Event|Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
275916|NCT00961259|E2|Reported Event|Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B|Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275917|NCT00961259|E1|Reported Event|Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
275918|NCT00961233|B3|Baseline|Total|Total of all reporting groups
275919|NCT00961233|B2|Baseline|Viscous/Swallowed Budesonide|
275920|NCT00961233|B1|Baseline|Inhaled/Swallowed Budesonide|
275921|NCT00961233|P2|Participant Flow|Viscous/Swallowed Budesonide|viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
275922|NCT00961233|P1|Participant Flow|Inhaled/Swallowed Budesonide|inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
275923|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|viscous slurry of budesonide and sucralose 1 mg twice daily
275924|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|nebulized then swallowed budesonide 1mg twice daily
275925|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|
275926|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|
275927|NCT00961233|E2|Reported Event|Viscous/Swallowed Budesonide|
275928|NCT00961233|E1|Reported Event|Inhaled/Swallowed Budesonide|
280059|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
275929|NCT00961220|B1|Baseline|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275930|NCT00961220|P1|Participant Flow|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275931|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275932|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275933|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275934|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275935|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275936|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275937|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275938|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
276002|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276003|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
275939|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275940|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275941|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275942|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275943|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV~carmustine: Applied topically~laboratory biomarker analysis: Correlative studies"
275944|NCT00961220|E1|Reported Event|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
275945|NCT00961181|B1|Baseline|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275946|NCT00961181|P1|Participant Flow|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275947|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275948|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275949|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275950|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275951|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275952|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275953|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275954|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275955|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275956|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
275957|NCT00961181|E1|Reported Event|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
276004|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
275958|NCT00961116|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
275959|NCT00961116|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
275960|NCT00961116|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
275961|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
275962|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
275963|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
275964|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
275965|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
275966|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
275967|NCT00961116|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
275968|NCT00961116|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
275969|NCT00961051|B3|Baseline|Total|Total of all reporting groups
275970|NCT00961051|B2|Baseline|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
275971|NCT00961051|B1|Baseline|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
275972|NCT00961051|P2|Participant Flow|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
275973|NCT00961051|P1|Participant Flow|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
275974|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
275975|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
275976|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
275977|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
275978|NCT00961051|E2|Reported Event|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
275979|NCT00961051|E1|Reported Event|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
275980|NCT00960999|B3|Baseline|Total|Total of all reporting groups
275981|NCT00960999|B2|Baseline|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
275982|NCT00960999|B1|Baseline|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
275983|NCT00960999|P2|Participant Flow|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
275984|NCT00960999|P1|Participant Flow|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
275985|NCT00960999|O2|Outcome|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
275986|NCT00960999|O1|Outcome|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
275987|NCT00960999|E2|Reported Event|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
275988|NCT00960999|E1|Reported Event|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
275989|NCT00960986|B5|Baseline|Total|Total of all reporting groups
275990|NCT00960986|B4|Baseline|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
275991|NCT00960986|B3|Baseline|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
275992|NCT00960986|B2|Baseline|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
275993|NCT00960986|B1|Baseline|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
275994|NCT00960986|P4|Participant Flow|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
275995|NCT00960986|P3|Participant Flow|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
275996|NCT00960986|P2|Participant Flow|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
275997|NCT00960986|P1|Participant Flow|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
275998|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
275999|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276000|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276001|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
280060|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
276005|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276006|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276007|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276008|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276009|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276010|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276011|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276012|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276013|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276014|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276015|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276016|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276017|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276018|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276019|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276020|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276021|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276022|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276023|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276024|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276025|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276026|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276027|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276028|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276029|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276030|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276031|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276032|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276033|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276034|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276035|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276036|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276037|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276038|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276039|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276040|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276041|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276042|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276043|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276044|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276045|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276046|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276047|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276048|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276049|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276050|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276051|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276052|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
280061|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
276053|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276054|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276055|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276056|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276057|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276058|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276059|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276060|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276061|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276062|NCT00960986|E4|Reported Event|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
276063|NCT00960986|E3|Reported Event|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
276064|NCT00960986|E2|Reported Event|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
276065|NCT00960986|E1|Reported Event|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
276066|NCT00960934|B7|Baseline|Total|Total of all reporting groups
276067|NCT00960934|B6|Baseline|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276068|NCT00960934|B5|Baseline|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276069|NCT00960934|B4|Baseline|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276070|NCT00960934|B3|Baseline|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276071|NCT00960934|B2|Baseline|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276072|NCT00960934|B1|Baseline|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276073|NCT00960934|P6|Participant Flow|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276074|NCT00960934|P5|Participant Flow|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276075|NCT00960934|P4|Participant Flow|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276076|NCT00960934|P3|Participant Flow|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276077|NCT00960934|P2|Participant Flow|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276078|NCT00960934|P1|Participant Flow|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276079|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276080|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276081|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276082|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276083|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276084|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276085|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276086|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276087|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276088|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276089|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276090|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276091|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276092|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276093|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276094|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276095|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276096|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276097|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276098|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276099|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276100|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276101|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276102|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276103|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276104|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276105|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276106|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276107|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276108|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276109|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276110|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276111|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276112|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276113|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276114|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276115|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276116|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276117|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276118|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276119|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276120|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276121|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276122|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276123|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276124|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276125|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276126|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276127|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276128|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276289|NCT00960622|O1|Outcome|Truvada 200/300 mg, Daily, by Mouth.|switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
276129|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276130|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276131|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276132|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276133|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276134|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276135|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276136|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276137|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276138|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276139|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276140|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276141|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276142|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276143|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276144|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276145|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276146|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276147|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276148|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276149|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276150|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276151|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276152|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276153|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276154|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276155|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276156|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276157|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276158|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276159|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276160|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276161|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276162|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276163|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276164|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276290|NCT00960622|E2|Reported Event|Combivir, Trizivir.|continue on Combivir, trizivir.
276165|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276166|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276167|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276168|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276169|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276170|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276171|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276172|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276173|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276174|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276175|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276176|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276177|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276178|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276179|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276180|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276181|NCT00960934|E6|Reported Event|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
276182|NCT00960934|E5|Reported Event|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
276183|NCT00960934|E4|Reported Event|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
276184|NCT00960934|E3|Reported Event|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
276185|NCT00960934|E2|Reported Event|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
276186|NCT00960934|E1|Reported Event|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
276187|NCT00960869|B3|Baseline|Total|Total of all reporting groups
276188|NCT00960869|B2|Baseline|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276189|NCT00960869|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276190|NCT00960869|P2|Participant Flow|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276191|NCT00960869|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276192|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276193|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276194|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276195|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276196|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276197|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276198|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276199|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276200|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276201|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276202|NCT00960869|E2|Reported Event|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
276203|NCT00960869|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
276291|NCT00960622|E1|Reported Event|Truvada|switch from Combivir to Truvada
276634|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276204|NCT00960856|B1|Baseline|Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted|All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
276205|NCT00960856|P4|Participant Flow|Sequence DABC|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
276206|NCT00960856|P3|Participant Flow|Sequence CDAB|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
276207|NCT00960856|P2|Participant Flow|Sequence BCDA|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
276208|NCT00960856|P1|Participant Flow|Sequence ABCD|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
276209|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
276210|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
276211|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
276212|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
276213|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
276214|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
276215|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
276216|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
276217|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
276218|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
276219|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
276220|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
276221|NCT00960856|E4|Reported Event|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
276222|NCT00960856|E3|Reported Event|High-fat, High-calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
276223|NCT00960856|E2|Reported Event|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
276224|NCT00960856|E1|Reported Event|Low-Fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
276225|NCT00960843|B3|Baseline|Total|Total of all reporting groups
276226|NCT00960843|B2|Baseline|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
276227|NCT00960843|B1|Baseline|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
276228|NCT00960843|P2|Participant Flow|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
276229|NCT00960843|P1|Participant Flow|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
276230|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
276231|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
276232|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
276233|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
276234|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
276235|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
276236|NCT00960843|E2|Reported Event|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
276237|NCT00960843|E1|Reported Event|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
276238|NCT00960687|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
276239|NCT00960687|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
276240|NCT00960687|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
276241|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
276242|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
276243|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
276244|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
276245|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
276246|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
276247|NCT00960687|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
276248|NCT00960687|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
276249|NCT00960661|B3|Baseline|Total|Total of all reporting groups
276250|NCT00960661|B2|Baseline|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276251|NCT00960661|B1|Baseline|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276252|NCT00960661|P3|Participant Flow|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276253|NCT00960661|P2|Participant Flow|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276254|NCT00960661|P1|Participant Flow|Enrolled|Patients who enrolled in the basal insulin optimization (BIO) phase
276255|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276256|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276257|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276258|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276259|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276260|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276261|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276262|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276263|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276264|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276265|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276266|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276267|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276268|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276269|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276270|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276271|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276272|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276273|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276274|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276275|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276276|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276277|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276278|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276279|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276280|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276281|NCT00960661|E2|Reported Event|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
276282|NCT00960661|E1|Reported Event|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
276283|NCT00960622|B3|Baseline|Total|Total of all reporting groups
276284|NCT00960622|B2|Baseline|Combivir, Trizivir.|continue on Combivir, trizivir.
276285|NCT00960622|B1|Baseline|Truvada|switch from Combivir to Truvada
276286|NCT00960622|P2|Participant Flow|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
276287|NCT00960622|P1|Participant Flow|Truvada 200/300 mg, Daily, by Mouth.|The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
276288|NCT00960622|O2|Outcome|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
276464|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276292|NCT00960570|B1|Baseline|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
276293|NCT00960570|P1|Participant Flow|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
276294|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
276295|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
276296|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
276297|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
276298|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
276299|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
276300|NCT00960570|E3|Reported Event|Efavirenz and Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
276301|NCT00960570|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
276302|NCT00960570|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
276303|NCT00960531|B11|Baseline|Total|Total of all reporting groups
276304|NCT00960531|B10|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276305|NCT00960531|B9|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276306|NCT00960531|B8|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276307|NCT00960531|B7|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276308|NCT00960531|B6|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276309|NCT00960531|B5|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276310|NCT00960531|B4|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276311|NCT00960531|B3|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276312|NCT00960531|B2|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276313|NCT00960531|B1|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276314|NCT00960531|P10|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276315|NCT00960531|P9|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276316|NCT00960531|P8|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276317|NCT00960531|P7|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276318|NCT00960531|P6|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276319|NCT00960531|P5|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276320|NCT00960531|P4|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276321|NCT00960531|P3|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276322|NCT00960531|P2|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276323|NCT00960531|P1|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276324|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276325|NCT00960531|O9|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276326|NCT00960531|O8|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276327|NCT00960531|O7|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276328|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276329|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276330|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276331|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276332|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276333|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276334|NCT00960531|O6|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276335|NCT00960531|O5|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276336|NCT00960531|O4|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276337|NCT00960531|O3|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276338|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276339|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276340|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276341|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276342|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276343|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276465|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276344|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276345|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276346|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276347|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276348|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276349|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276350|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276351|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276352|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276353|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276354|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276355|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276356|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276357|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276358|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276359|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276360|NCT00960531|E6|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276361|NCT00960531|E5|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276362|NCT00960531|E4|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276363|NCT00960531|E3|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276364|NCT00960531|E2|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276365|NCT00960531|E1|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
276366|NCT00960440|B5|Baseline|Total|Total of all reporting groups
276367|NCT00960440|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276368|NCT00960440|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276369|NCT00960440|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276370|NCT00960440|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276371|NCT00960440|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276372|NCT00960440|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276373|NCT00960440|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276374|NCT00960440|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
276375|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276376|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276377|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276378|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276379|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276380|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276381|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276382|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276383|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276384|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276385|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276386|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276387|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276388|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276389|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276390|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276391|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276392|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276393|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276394|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276395|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276396|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276397|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276398|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276399|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276400|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276401|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276402|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276403|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276404|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276405|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276406|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276407|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276408|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276409|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276410|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276411|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276412|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276413|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276414|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276415|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276416|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276417|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276418|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276419|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276420|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276421|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276422|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276423|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276424|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276425|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276426|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276427|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276428|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276429|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276430|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276431|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276432|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276433|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276434|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276435|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276436|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276437|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276438|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276439|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276440|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276441|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276442|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276443|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276444|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276445|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276446|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276447|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276448|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276449|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276450|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276451|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276452|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276453|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276454|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276455|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276456|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276457|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276458|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276459|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276460|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276461|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276462|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276463|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
280062|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
276466|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276467|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276468|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276469|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276470|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276471|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276472|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276473|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276474|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276475|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276476|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276477|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276478|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276479|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276480|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276481|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276482|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276483|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276484|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276485|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276486|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276487|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276488|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276489|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276490|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276491|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276492|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276493|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276494|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276495|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276496|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276497|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276498|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276499|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276500|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276501|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276502|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276503|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276504|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276505|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276506|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276507|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276508|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276509|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276510|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276511|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
280063|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
276512|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276513|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276514|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276515|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276516|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276517|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276518|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276519|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276520|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276521|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276522|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
276523|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
276524|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276525|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276526|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276527|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276528|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276529|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276530|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276531|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276532|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276533|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276534|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276535|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
276536|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
276537|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
276538|NCT00960440|E5|Reported Event|CP-690,550 10 mg From Month 3 to 6|CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
276539|NCT00960440|E4|Reported Event|CP-690,550 5 mg From Month 3 to 6|CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
276540|NCT00960440|E3|Reported Event|Placebo Up to Month 3|Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
276541|NCT00960440|E2|Reported Event|CP-690,550 10 mg Up to Month 3|CP-690,550 10 mg tablets orally twice daily up to Month 3.
276542|NCT00960440|E1|Reported Event|CP-690,550 5 mg Up to Month 3|CP-690,550 5 mg tablet orally twice daily up to Month 3.
276543|NCT00960375|B3|Baseline|Total|Total of all reporting groups
276544|NCT00960375|B2|Baseline|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
276545|NCT00960375|B1|Baseline|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
276555|NCT00960323|P1|Participant Flow|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
276556|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
276557|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
276546|NCT00960375|P2|Participant Flow|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
276547|NCT00960375|P1|Participant Flow|BTSCS|BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
276548|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
276549|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
276550|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
276551|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
276552|NCT00960375|E2|Reported Event|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups provide education about smoking and support for quitting. Smoking education groups involve weekly (24 groups total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
276553|NCT00960375|E1|Reported Event|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
276554|NCT00960323|B1|Baseline|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
276558|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
280064|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
276559|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
276560|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
276561|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast followed by a 14 day washout period.
276562|NCT00960323|E3|Reported Event|Colchicine and Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
276563|NCT00960323|E2|Reported Event|Atorvastatin Alone|On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
276564|NCT00960323|E1|Reported Event|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
276565|NCT00960297|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
276566|NCT00960297|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
276567|NCT00960297|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
276568|NCT00960297|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
276569|NCT00960206|B4|Baseline|Total|Total of all reporting groups
276570|NCT00960206|B3|Baseline|Control|Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
276571|NCT00960206|B2|Baseline|ABC System|Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
276572|NCT00960206|B1|Baseline|Trident System|Trident Ceramic Insert/Trident AD with PureFix HA Shell
276573|NCT00960206|P3|Participant Flow|Control|Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276574|NCT00960206|P2|Participant Flow|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276575|NCT00960206|P1|Participant Flow|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276576|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276577|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276578|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276579|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276580|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276581|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276582|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276583|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276584|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276585|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276586|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276587|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276588|NCT00960206|E4|Reported Event|All Participants|All participants combined.
276589|NCT00960206|E3|Reported Event|Control|Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
276590|NCT00960206|E2|Reported Event|ABC System|Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
276591|NCT00960206|E1|Reported Event|Trident® System|Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
276592|NCT00960193|B1|Baseline|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
276593|NCT00960193|P1|Participant Flow|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
276632|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276633|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276594|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
276595|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
276596|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
276597|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
276598|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
276599|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
276600|NCT00960193|E3|Reported Event|Colchicine With Seville Orange Juice|On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
276601|NCT00960193|E2|Reported Event|Seville Orange Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
276602|NCT00960193|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
276603|NCT00960154|B3|Baseline|Total|Total of all reporting groups
276604|NCT00960154|B2|Baseline|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
276605|NCT00960154|B1|Baseline|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
276606|NCT00960154|P2|Participant Flow|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
276607|NCT00960154|P1|Participant Flow|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
276608|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
276609|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
276610|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
276611|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
276612|NCT00960154|E2|Reported Event|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
276613|NCT00960154|E1|Reported Event|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
276614|NCT00960141|B4|Baseline|Total|Total of all reporting groups
276615|NCT00960141|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276616|NCT00960141|B2|Baseline|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276617|NCT00960141|B1|Baseline|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276618|NCT00960141|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276619|NCT00960141|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276620|NCT00960141|P1|Participant Flow|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276621|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276622|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276623|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276624|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276625|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276626|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276627|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276628|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276629|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276630|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276631|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276793|NCT00959907|P2|Participant Flow|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
276635|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276636|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276637|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276638|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276639|NCT00960141|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
276640|NCT00960141|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
276641|NCT00960141|E1|Reported Event|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
276642|NCT00960115|B3|Baseline|Total|Total of all reporting groups
276643|NCT00960115|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276644|NCT00960115|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276645|NCT00960115|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276646|NCT00960115|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
276647|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276648|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276649|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276650|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276651|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276652|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276653|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276654|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276688|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276794|NCT00959907|P1|Participant Flow|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
276655|NCT00960115|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
276656|NCT00960115|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
276657|NCT00960076|B3|Baseline|Total|Total of all reporting groups
276658|NCT00960076|B2|Baseline|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276659|NCT00960076|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276660|NCT00960076|P2|Participant Flow|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276661|NCT00960076|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276662|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276663|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276664|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276665|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276666|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276667|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276668|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276669|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276670|NCT00960076|E2|Reported Event|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
276671|NCT00960076|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
276672|NCT00960063|B4|Baseline|Total|Total of all reporting groups
276673|NCT00960063|B3|Baseline|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276674|NCT00960063|B2|Baseline|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276675|NCT00960063|B1|Baseline|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276676|NCT00960063|P3|Participant Flow|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276677|NCT00960063|P2|Participant Flow|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276678|NCT00960063|P1|Participant Flow|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276679|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276680|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276681|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276682|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276683|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276684|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276685|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276686|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276687|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276715|NCT00959946|B9|Baseline|Total|Total of all reporting groups
276858|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
276689|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276690|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276691|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276692|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276693|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276694|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276695|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276696|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276697|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276698|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276699|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276700|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276701|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276702|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276703|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276704|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276705|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276706|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276707|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276708|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276709|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276710|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276711|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276712|NCT00960063|E3|Reported Event|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276713|NCT00960063|E2|Reported Event|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276714|NCT00960063|E1|Reported Event|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
276716|NCT00959946|B8|Baseline|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276717|NCT00959946|B7|Baseline|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276718|NCT00959946|B6|Baseline|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276719|NCT00959946|B5|Baseline|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276720|NCT00959946|B4|Baseline|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276721|NCT00959946|B3|Baseline|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276722|NCT00959946|B2|Baseline|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276723|NCT00959946|B1|Baseline|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
276724|NCT00959946|P8|Participant Flow|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276725|NCT00959946|P7|Participant Flow|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276726|NCT00959946|P6|Participant Flow|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276727|NCT00959946|P5|Participant Flow|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276728|NCT00959946|P4|Participant Flow|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276729|NCT00959946|P3|Participant Flow|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276730|NCT00959946|P2|Participant Flow|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276731|NCT00959946|P1|Participant Flow|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
276732|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276733|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276789|NCT00959920|E1|Reported Event|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
276790|NCT00959907|B3|Baseline|Total|Total of all reporting groups
276734|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276735|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276736|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276737|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276738|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276739|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276740|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276741|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276742|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276743|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276744|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276745|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276746|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276764|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276859|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
276747|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276748|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276749|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276750|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276751|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276752|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276753|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276754|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276755|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276756|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276757|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276758|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276759|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
276760|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
276761|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
276762|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276763|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276765|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276766|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276767|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276768|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276769|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
276770|NCT00959946|O3|Outcome|Bosutinib + Capecitabine 1000 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276771|NCT00959946|O2|Outcome|Bosutinib + Capecitabine 750 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276772|NCT00959946|O1|Outcome|Bosutinib + Capecitabine 625 mg/m^2|Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276773|NCT00959946|E8|Reported Event|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276774|NCT00959946|E7|Reported Event|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276775|NCT00959946|E6|Reported Event|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276776|NCT00959946|E5|Reported Event|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276777|NCT00959946|E4|Reported Event|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276778|NCT00959946|E3|Reported Event|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276779|NCT00959946|E2|Reported Event|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
276780|NCT00959946|E1|Reported Event|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
276781|NCT00959920|B3|Baseline|Total|Total of all reporting groups
276782|NCT00959920|B2|Baseline|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
276783|NCT00959920|B1|Baseline|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
276784|NCT00959920|P2|Participant Flow|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
276785|NCT00959920|P1|Participant Flow|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
276786|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
276787|NCT00959920|O1|Outcome|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
276788|NCT00959920|E2|Reported Event|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
276795|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
276796|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
276797|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
276798|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
276799|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
276800|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
276801|NCT00959907|E2|Reported Event|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
276802|NCT00959907|E1|Reported Event|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
276803|NCT00959894|B1|Baseline|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276804|NCT00959894|P1|Participant Flow|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276805|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276806|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276807|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276808|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276809|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276810|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276811|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276812|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276813|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276814|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276815|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276816|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276817|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276818|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276860|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
276861|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
276819|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276820|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276821|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276822|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276823|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276824|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276825|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276826|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276827|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276828|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276829|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276830|NCT00959894|E1|Reported Event|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
276831|NCT00959764|B4|Baseline|Total|Total of all reporting groups
276832|NCT00959764|B3|Baseline|Placebo|Patients who did not receive any active treatment
276833|NCT00959764|B2|Baseline|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
276834|NCT00959764|B1|Baseline|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
276835|NCT00959764|P3|Participant Flow|Placebo|Patients who did not receive any active treatment
276836|NCT00959764|P2|Participant Flow|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
276837|NCT00959764|P1|Participant Flow|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
276838|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
276839|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
276840|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
276841|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
276842|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
276843|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
276844|NCT00959764|O3|Outcome|Placebo|Patients who were provided nasal and oral placebo medication in a blinded fashion
276845|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
276846|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
276847|NCT00959764|E3|Reported Event|Placebo|Patients who did not receive any active treatment
276848|NCT00959764|E2|Reported Event|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
276849|NCT00959764|E1|Reported Event|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
276850|NCT00959751|B3|Baseline|Total|Total of all reporting groups
276851|NCT00959751|B2|Baseline|Placebo|3 x 0 mg capsules
276852|NCT00959751|B1|Baseline|NXN-188|3 x 200 mg capsules
276853|NCT00959751|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules, PRN
276854|NCT00959751|P1|Participant Flow|Placebo|3 x capsules, PRN
276855|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
276856|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
276857|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
276872|NCT00959751|E1|Reported Event|NXN-188 600 mg|3 x 200 mg capsules, PRN
276873|NCT00959699|B3|Baseline|Total|Total of all reporting groups
276874|NCT00959699|B2|Baseline|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276875|NCT00959699|B1|Baseline|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276876|NCT00959699|P2|Participant Flow|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276877|NCT00959699|P1|Participant Flow|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276878|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276879|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276880|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276881|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276882|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276883|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276884|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276885|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276886|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276887|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276888|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276889|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276890|NCT00959699|E3|Reported Event|Boceprevir Crossover|(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
276891|NCT00959699|E2|Reported Event|PegIFN-2b+RBV+Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
276892|NCT00959699|E1|Reported Event|PegIFN-2b+RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
276893|NCT00959647|B1|Baseline|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
276894|NCT00959647|P1|Participant Flow|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
276895|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
276896|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
276897|NCT00959647|E1|Reported Event|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
276898|NCT00959374|B1|Baseline|V-loc and Monocryl|All randomized subjects
276899|NCT00959374|P1|Participant Flow|V-loc and Monocryl|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
276900|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
276901|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
276902|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
276903|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
276904|NCT00959374|E4|Reported Event|Non-protocol Incision or Systemic Events|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
276905|NCT00959374|E3|Reported Event|Midline|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
276906|NCT00959374|E2|Reported Event|Control - Monocryl 3-0|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
276907|NCT00959374|E1|Reported Event|V-Loc 180 / 90|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
276908|NCT00959192|B5|Baseline|Total|Total of all reporting groups
276909|NCT00959192|B4|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276910|NCT00959192|B3|Baseline|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276911|NCT00959192|B2|Baseline|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276912|NCT00959192|B1|Baseline|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276913|NCT00959192|P4|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276914|NCT00959192|P3|Participant Flow|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276915|NCT00959192|P2|Participant Flow|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276916|NCT00959192|P1|Participant Flow|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276917|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276918|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276919|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276920|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276921|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276922|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276923|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276924|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276925|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276926|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276927|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276928|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276929|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276930|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276931|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276932|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276933|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276934|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276935|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276936|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276937|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276938|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276939|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276940|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276941|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276942|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276943|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276944|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276945|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276946|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276947|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276948|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
276949|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276950|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276951|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276952|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276953|NCT00959192|E4|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276954|NCT00959192|E3|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276955|NCT00959192|E2|Reported Event|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276956|NCT00959192|E1|Reported Event|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
276957|NCT00959049|B7|Baseline|Total|Total of all reporting groups
276958|NCT00959049|B6|Baseline|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276959|NCT00959049|B5|Baseline|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276960|NCT00959049|B4|Baseline|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276961|NCT00959049|B3|Baseline|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276962|NCT00959049|B2|Baseline|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276963|NCT00959049|B1|Baseline|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
276964|NCT00959049|P6|Participant Flow|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276965|NCT00959049|P5|Participant Flow|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276966|NCT00959049|P4|Participant Flow|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276967|NCT00959049|P3|Participant Flow|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276968|NCT00959049|P2|Participant Flow|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276969|NCT00959049|P1|Participant Flow|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
276970|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
276971|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
276972|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
276973|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
276974|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
276975|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
276976|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 3 to < 9 years
276977|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years
276978|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
276979|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years
276980|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years
276981|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
276982|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276983|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276984|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276985|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276986|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276987|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
276988|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276989|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276990|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276991|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276992|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276993|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
276994|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276995|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276996|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
276997|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276998|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
276999|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
277000|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277001|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277002|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277003|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
277004|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
277005|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
277006|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
277007|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
277008|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
277009|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
277010|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
277011|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
277012|NCT00959049|E6|Reported Event|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277013|NCT00959049|E5|Reported Event|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277014|NCT00959049|E4|Reported Event|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
277015|NCT00959049|E3|Reported Event|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
277016|NCT00959049|E2|Reported Event|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
277017|NCT00959049|E1|Reported Event|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
277018|NCT00958919|B1|Baseline|Entire Study Population|Includes groups randomized to receive saline first and Naxolone first.
277019|NCT00958919|P2|Participant Flow|Naloxone First, Then Normal Saline|Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
277020|NCT00958919|P1|Participant Flow|Normal Saline First, Then Naloxone|Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
277021|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Normal Saline (25 ml)
277022|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Normal Saline (25 ml)
277023|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Naloxone (10 mg/25 ml)
277024|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Naloxone (10 mg/25 ml)
277025|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)given prior to start of Resistive Load Breathing
277026|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml) given prior to start of Resistive Load Breathing
277027|NCT00958919|O2|Outcome|Naloxone|Intravension Naloxone (10mg/25ml)
277028|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
277029|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)
277030|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
277031|NCT00958919|E2|Reported Event|Naloxone|10mg/25ml Intravenous
277032|NCT00958919|E1|Reported Event|Normal Saline|25 ml Intravenous
277033|NCT00958893|B1|Baseline|25 mg Proellex|25 mg Proellex daily
277034|NCT00958893|P1|Participant Flow|25 mg Proellex|25 mg Proellex: one 25 mg capsules
277035|NCT00958893|O1|Outcome|25 mg Proellex|25 mg Proellex: one 25 mg capsules
277036|NCT00958893|E1|Reported Event|25 mg Proellex|25 mg Proellex: one 25 mg capsules
277037|NCT00958880|B3|Baseline|Total|Total of all reporting groups
277038|NCT00958880|B2|Baseline|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
277039|NCT00958880|B1|Baseline|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
277040|NCT00958880|P2|Participant Flow|Yohimbine Hydrochloride|Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
277041|NCT00958880|P1|Participant Flow|Sugar Pill|Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
277042|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
277043|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
277044|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
277213|NCT00958334|B2|Baseline|Proellex 12.5 mg|Proellex® 12.5 mg once daily
277045|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
277046|NCT00958880|E2|Reported Event|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
277047|NCT00958880|E1|Reported Event|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
277048|NCT00958841|B1|Baseline|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
277049|NCT00958841|P1|Participant Flow|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
277050|NCT00958841|O1|Outcome|Nelson's Syndrome|Nelson’s syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
277051|NCT00958841|O1|Outcome|All PiNETS (Prolactinoma)|One of the 10 types of PiNETs analyzed
277052|NCT00958841|O1|Outcome|All PNETS (Gastrinoma)|One of the 10 types of PNETs analyzed
277053|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
277054|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
277055|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
277056|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
277057|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
277058|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
277059|NCT00958841|O3|Outcome|Glucagonoma|One of the 10 types of PNETs analyzed.
277060|NCT00958841|O2|Outcome|VIpoma|One of the 10 types of PNETs analyzed.
277061|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
277062|NCT00958841|E4|Reported Event|Nelsons Syndrome|Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
277063|NCT00958841|E3|Reported Event|Ectopic ACTH-secrting Tumors (EAS)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
277064|NCT00958841|E2|Reported Event|Pituitary NETs (PiNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
277065|NCT00958841|E1|Reported Event|Pancreatic NETs (PNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
277066|NCT00958828|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
277067|NCT00958828|P2|Participant Flow|Narafilcon A / Nelfilcon A|Narafilcon A contact lenses, then Nelfilcon A contact lenses
277068|NCT00958828|P1|Participant Flow|Nelfilcon A / Narafilcon A|Nelfilcon A contact lenses, then Narafilcon A contact lenses
277069|NCT00958828|O2|Outcome|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
277070|NCT00958828|O1|Outcome|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
277071|NCT00958828|E2|Reported Event|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
277072|NCT00958828|E1|Reported Event|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
277073|NCT00958776|B3|Baseline|Total|Total of all reporting groups
277074|NCT00958776|B2|Baseline|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277075|NCT00958776|B1|Baseline|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277076|NCT00958776|P2|Participant Flow|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277077|NCT00958776|P1|Participant Flow|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277078|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277079|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277130|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277080|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277081|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277082|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277083|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277084|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277085|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277086|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277087|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277088|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277089|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277090|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277091|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277092|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277093|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277094|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277095|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277096|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277097|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277098|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277099|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277100|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277101|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277131|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277210|NCT00958347|E1|Reported Event|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
277102|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277103|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277104|NCT00958776|E2|Reported Event|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
277105|NCT00958776|E1|Reported Event|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
277106|NCT00958568|B1|Baseline|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
277107|NCT00958568|P4|Participant Flow|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277108|NCT00958568|P3|Participant Flow|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
277109|NCT00958568|P2|Participant Flow|OFC (SPIII)|6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
277110|NCT00958568|P1|Participant Flow|OFC (SPII )|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
277111|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277112|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
277113|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277114|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277115|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277116|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277117|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277118|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277119|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277120|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277121|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277122|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277123|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277124|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277125|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277126|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277127|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277128|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277129|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277163|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277132|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277133|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277134|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277135|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277136|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277137|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277138|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277139|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277140|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277141|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277142|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277143|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277144|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277145|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277146|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277147|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277148|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277149|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277150|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277151|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277152|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277153|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277154|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277155|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277156|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277157|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277158|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277159|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277160|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277161|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277162|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277164|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277165|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277166|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277167|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
277168|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
277169|NCT00958568|O1|Outcome|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
277170|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277171|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277172|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277173|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277174|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277175|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277176|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277177|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277178|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277179|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277180|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277181|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277182|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277183|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277184|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277185|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277186|NCT00958568|E4|Reported Event|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
277187|NCT00958568|E3|Reported Event|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
277188|NCT00958568|E2|Reported Event|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
277189|NCT00958568|E1|Reported Event|OFC (SPII)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
277190|NCT00958360|B3|Baseline|Total|Total of all reporting groups
277191|NCT00958360|B2|Baseline|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277208|NCT00958347|P1|Participant Flow|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
277209|NCT00958347|O1|Outcome|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
277211|NCT00958334|B4|Baseline|Total|Total of all reporting groups
277192|NCT00958360|B1|Baseline|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277193|NCT00958360|P2|Participant Flow|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277194|NCT00958360|P1|Participant Flow|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277195|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277196|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277197|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277198|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277199|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277200|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277201|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277202|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277203|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277204|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277205|NCT00958360|E2|Reported Event|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
277206|NCT00958360|E1|Reported Event|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
277207|NCT00958347|B1|Baseline|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
277212|NCT00958334|B3|Baseline|Placebo Comparator|Placebo capsule once daily
277214|NCT00958334|B1|Baseline|Proellex 25 mg|Proellex® 12.5 mg twice daily
277215|NCT00958334|P3|Participant Flow|Placebo Comparator|Placebo capsules orally QD
277216|NCT00958334|P2|Participant Flow|Proellex 12.5 mg|Proellex® 12.5 mg capsules orally QD
277217|NCT00958334|P1|Participant Flow|Proellex 25 mg|Proellex® 12.5 mg orally capsules BID
277218|NCT00958334|O3|Outcome|Placebo Comparator|Placebo capsule once daily
277219|NCT00958334|O2|Outcome|Proellex 12.5 mg|Proellex® 12.5 mg once daily
277220|NCT00958334|O1|Outcome|Proellex 25 mg|Proellex® 12.5 mg twice daily
277221|NCT00958334|E3|Reported Event|Placebo Comparator|Placebo capsule once daily
277222|NCT00958334|E2|Reported Event|Proellex 12.5 mg|Proellex® 12.5 mg once daily
277223|NCT00958334|E1|Reported Event|Proellex 25 mg|Proellex® 12.5 mg twice daily
277224|NCT00958308|B4|Baseline|Total|Total of all reporting groups
277225|NCT00958308|B3|Baseline|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277226|NCT00958308|B2|Baseline|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277227|NCT00958308|B1|Baseline|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277228|NCT00958308|P3|Participant Flow|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277229|NCT00958308|P2|Participant Flow|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277230|NCT00958308|P1|Participant Flow|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277231|NCT00958308|O3|Outcome|BIO-K+ CL-1285|Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277232|NCT00958308|O2|Outcome|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277233|NCT00958308|O1|Outcome|Placebo|Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277234|NCT00958308|E3|Reported Event|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277235|NCT00958308|E2|Reported Event|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277236|NCT00958308|E1|Reported Event|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
277237|NCT00958282|B3|Baseline|Total|Total of all reporting groups
277238|NCT00958282|B2|Baseline|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
277239|NCT00958282|B1|Baseline|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
277240|NCT00958282|P2|Participant Flow|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
277241|NCT00958282|P1|Participant Flow|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
277242|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
277243|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
277244|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
277245|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
277246|NCT00958282|E2|Reported Event|Placebo|"Placebo Comparator once per day~placebo"
277247|NCT00958282|E1|Reported Event|Lisdexamfetamine/Behavior Therapy|"lisdexamfetamine 70mg/day plus Behavior Therapy~lisdexamfetamine/Behavior Therapy"
277248|NCT00958256|B1|Baseline|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
277300|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
277301|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277302|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277249|NCT00958256|P1|Participant Flow|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
277250|NCT00958256|O1|Outcome|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
277251|NCT00958256|E1|Reported Event|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
277252|NCT00958243|B7|Baseline|Total|Total of all reporting groups
277253|NCT00958243|B6|Baseline|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277254|NCT00958243|B5|Baseline|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277255|NCT00958243|B4|Baseline|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277256|NCT00958243|B3|Baseline|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277257|NCT00958243|B2|Baseline|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277258|NCT00958243|B1|Baseline|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277259|NCT00958243|P6|Participant Flow|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277260|NCT00958243|P5|Participant Flow|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277261|NCT00958243|P4|Participant Flow|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277262|NCT00958243|P3|Participant Flow|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277263|NCT00958243|P2|Participant Flow|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277264|NCT00958243|P1|Participant Flow|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277265|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277266|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277267|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277268|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277269|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277270|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277271|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277272|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277273|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277274|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277275|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277276|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277277|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
277278|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
277279|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
277280|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277281|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277282|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277283|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277284|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277285|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277286|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277287|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277288|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277289|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277290|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277291|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277292|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
277293|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
277294|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
277295|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
277296|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
277297|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
277298|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
277299|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
277303|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277304|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277305|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277306|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277307|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277308|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277309|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277310|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277311|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277312|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277313|NCT00958243|E6|Reported Event|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277314|NCT00958243|E5|Reported Event|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
277315|NCT00958243|E4|Reported Event|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
277316|NCT00958243|E3|Reported Event|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277317|NCT00958243|E2|Reported Event|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
277318|NCT00958243|E1|Reported Event|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
277319|NCT00958217|B3|Baseline|Total|Total of all reporting groups
277320|NCT00958217|B2|Baseline|Arm 2: ICBT|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277321|NCT00958217|B1|Baseline|Arm 1: CPT-M|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277322|NCT00958217|P2|Participant Flow|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277323|NCT00958217|P1|Participant Flow|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277324|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277325|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277326|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277327|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277328|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277329|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277330|NCT00958217|E3|Reported Event|ICBT Prior to Randomization|"All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills.~This portion will report on only those participants who were not randomized to individual CPT-M or ICBT."
277331|NCT00958217|E2|Reported Event|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
277332|NCT00958217|E1|Reported Event|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
277333|NCT00958191|B1|Baseline|Trident® X3 Polyethylene Insert|All subjects who recieved the Trident X3 insert.
277334|NCT00958191|P1|Participant Flow|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
277335|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277336|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277337|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277338|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277339|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277340|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277341|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277342|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277343|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
277344|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received theTrident® X3 Polyethylene Insert
277345|NCT00958191|E1|Reported Event|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 Polyethylene Insert
277346|NCT00958165|B1|Baseline|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
277347|NCT00958165|P1|Participant Flow|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
277348|NCT00958165|O1|Outcome|EAS-AC|Pulmonary vein isolation treatment with EAS-AC for PAF
277349|NCT00958165|E1|Reported Event|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
277350|NCT00958126|B9|Baseline|Total|Total of all reporting groups
277351|NCT00958126|B8|Baseline|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277352|NCT00958126|B7|Baseline|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277353|NCT00958126|B6|Baseline|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277354|NCT00958126|B5|Baseline|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277355|NCT00958126|B4|Baseline|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277356|NCT00958126|B3|Baseline|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277357|NCT00958126|B2|Baseline|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277358|NCT00958126|B1|Baseline|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277359|NCT00958126|P8|Participant Flow|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277360|NCT00958126|P7|Participant Flow|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277361|NCT00958126|P6|Participant Flow|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277362|NCT00958126|P5|Participant Flow|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277363|NCT00958126|P4|Participant Flow|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277364|NCT00958126|P3|Participant Flow|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277365|NCT00958126|P2|Participant Flow|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277366|NCT00958126|P1|Participant Flow|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277367|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Age Cohorts Combined|30 mcg of hemagglutinin antigen per dose
277368|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Age Cohorts Combined|15 mcg of hemagglutinin antigen per dose
277369|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Age Cohorts Combined|7.5 mcg of hemagglutinin antigen per dose
277370|NCT00958126|O1|Outcome|Placebo, Age Cohorts Combined|Vaccine diluent
277371|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277372|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277373|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277374|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277375|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277376|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277377|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277378|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
280065|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
277379|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277380|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277381|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277382|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277383|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277384|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277385|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277386|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277387|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277388|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277389|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277390|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277391|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277392|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277393|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277394|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277395|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277396|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277397|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277398|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277399|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277400|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277401|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277402|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277403|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277404|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277405|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277406|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277407|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277408|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277409|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277410|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277411|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277412|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277413|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277414|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277415|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277416|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277417|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277418|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277419|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277420|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277421|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277422|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277423|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277424|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277425|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277426|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277427|NCT00958126|E8|Reported Event|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277428|NCT00958126|E7|Reported Event|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277429|NCT00958126|E6|Reported Event|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
277430|NCT00958126|E5|Reported Event|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
277431|NCT00958126|E4|Reported Event|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277432|NCT00958126|E3|Reported Event|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277433|NCT00958126|E2|Reported Event|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
277434|NCT00958126|E1|Reported Event|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
277435|NCT00958074|B3|Baseline|Total|Total of all reporting groups
277436|NCT00958074|B2|Baseline|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277437|NCT00958074|B1|Baseline|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277438|NCT00958074|P2|Participant Flow|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277439|NCT00958074|P1|Participant Flow|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277440|NCT00958074|O2|Outcome|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277441|NCT00958074|O1|Outcome|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277442|NCT00958074|E2|Reported Event|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277443|NCT00958074|E1|Reported Event|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
277444|NCT00958035|B3|Baseline|Total|Total of all reporting groups
277445|NCT00958035|B2|Baseline|Placebo|vehicle sterile solution
277446|NCT00958035|B1|Baseline|LATISSE®|bimatoprost ophthalmic 0.03% solution
277447|NCT00958035|P2|Participant Flow|Placebo|vehicle sterile solution
277448|NCT00958035|P1|Participant Flow|LATISSE®|bimatoprost ophthalmic 0.03% solution
277449|NCT00958035|O2|Outcome|Placebo|vehicle sterile solution
277450|NCT00958035|O1|Outcome|LATISSE®|bimatoprost ophthalmic 0.03% solution
277451|NCT00958035|E2|Reported Event|Placebo|vehicle sterile solution
277452|NCT00958035|E1|Reported Event|LATISSE®|bimatoprost ophthalmic 0.03% solution
277453|NCT00958009|B1|Baseline|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
277454|NCT00958009|P1|Participant Flow|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
277455|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
277456|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
277457|NCT00958009|E1|Reported Event|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
277458|NCT00957996|B3|Baseline|Total|Total of all reporting groups
277459|NCT00957996|B2|Baseline|Peramivir 600mg|"600 mg once daily~Peramivir: 600 mg once daily"
277460|NCT00957996|B1|Baseline|Peramivir 300mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
277461|NCT00957996|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg once daily
277462|NCT00957996|P1|Participant Flow|Peramivir 300 mg|Peramivir 300 mg twice daily
277463|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277464|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277465|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
277466|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
277467|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277468|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277469|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277470|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277471|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277472|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277473|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277474|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277475|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277476|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277477|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277478|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277479|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277480|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277481|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
277482|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
277483|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277484|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277485|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
277486|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
277487|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
277488|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
277489|NCT00957996|E2|Reported Event|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
277490|NCT00957996|E1|Reported Event|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
277491|NCT00957944|B3|Baseline|Total|Total of all reporting groups
277492|NCT00957944|B2|Baseline|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
277493|NCT00957944|B1|Baseline|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
277494|NCT00957944|P2|Participant Flow|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
277495|NCT00957944|P1|Participant Flow|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
277496|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277497|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277498|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277499|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277500|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277501|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277502|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277503|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277504|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277505|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277506|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277507|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277508|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277509|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277510|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277511|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277512|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277513|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277514|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277557|NCT00957658|B1|Baseline|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
277515|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277516|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277517|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277518|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277519|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277520|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277521|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277522|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277523|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277524|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277525|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277526|NCT00957944|E2|Reported Event|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
277527|NCT00957944|E1|Reported Event|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
277528|NCT00957723|B1|Baseline|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
277529|NCT00957723|P1|Participant Flow|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
277530|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277531|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277532|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277533|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277534|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277535|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277536|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277537|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
277538|NCT00957723|E1|Reported Event|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
277539|NCT00957684|B5|Baseline|Total|Total of all reporting groups
277540|NCT00957684|B4|Baseline|Placebo|Placebo tablets; once daily administration by oral route
277541|NCT00957684|B3|Baseline|ESL 400 mg|400-mg; once daily administration by oral route
277542|NCT00957684|B2|Baseline|ESL 800 mg|800-mg; once daily administration by oral route
277543|NCT00957684|B1|Baseline|ESL 1200 mg|400-mg + 800-mg; once daily administration by oral route
277544|NCT00957684|P5|Participant Flow|ESL - Part II|During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.
277545|NCT00957684|P4|Participant Flow|Placebo|placebo : once daily placebo comparator
277546|NCT00957684|P3|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277547|NCT00957684|P2|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277548|NCT00957684|P1|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277549|NCT00957684|O4|Outcome|ESL 1200 mg|ESL was supplied in 400-mg and 800-mg tablets; once daily administration by oral route.
277550|NCT00957684|O3|Outcome|ESL 800 mg|ESL was supplied in 800-mg tablets; once daily administration by oral route.
277551|NCT00957684|O2|Outcome|ESL 400 mg|ESL was supplied in 400-mg tablets; once daily administration by oral route.
277552|NCT00957684|O1|Outcome|Placebo|Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied; once daily administration by oral route.
277553|NCT00957684|E4|Reported Event|Placebo|placebo : once daily placebo comparator
277554|NCT00957684|E3|Reported Event|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277555|NCT00957684|E2|Reported Event|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277556|NCT00957684|E1|Reported Event|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
277558|NCT00957658|P1|Participant Flow|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
277559|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277560|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277561|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277562|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277563|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277564|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem.
277565|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277566|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277567|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
277568|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
277569|NCT00957658|E1|Reported Event|Accolade TMZF Hip Stem|Participants who received the Accolade TMZF Hip Stem
277570|NCT00956761|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277571|NCT00956761|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277572|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
277573|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277574|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277575|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277576|NCT00956761|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
277577|NCT00956709|B3|Baseline|Total|Total of all reporting groups
277578|NCT00956709|B2|Baseline|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277579|NCT00956709|B1|Baseline|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277580|NCT00956709|P2|Participant Flow|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277581|NCT00956709|P1|Participant Flow|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277582|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277583|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277584|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277585|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277586|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277587|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277588|NCT00956709|E2|Reported Event|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
277589|NCT00956709|E1|Reported Event|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
277590|NCT00956657|B3|Baseline|Total|Total of all reporting groups
277591|NCT00956657|B2|Baseline|Treatment As Usual|Control group. Treatment received as usual.
277592|NCT00956657|B1|Baseline|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
277593|NCT00956657|P2|Participant Flow|Treatment As Usual|Control group. Treatment received as usual.
277594|NCT00956657|P1|Participant Flow|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
277595|NCT00956657|O2|Outcome|Treatment As Usual|Control group. Treatment received as usual.
277596|NCT00956657|O1|Outcome|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
277597|NCT00956657|E2|Reported Event|Treatment As Usual|Control group. Treatment received as usual.
277598|NCT00956657|E1|Reported Event|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
277599|NCT00957593|B3|Baseline|Total|Total of all reporting groups
277600|NCT00957593|B2|Baseline|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
277601|NCT00957593|B1|Baseline|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
277602|NCT00957593|P2|Participant Flow|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
277603|NCT00957593|P1|Participant Flow|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
277604|NCT00957593|O2|Outcome|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
277605|NCT00957593|O1|Outcome|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
277606|NCT00957593|E2|Reported Event|Oxytocin Discontinuation|Oxytocin discontinuation in the active phase of labor
277607|NCT00957593|E1|Reported Event|Oxytocin Arm|no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM
277608|NCT00957528|B4|Baseline|Total|Total of all reporting groups
277609|NCT00957528|B3|Baseline|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277610|NCT00957528|B2|Baseline|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277611|NCT00957528|B1|Baseline|Placebo|Weekly placebo treatment for a duration of 5 months.
277612|NCT00957528|P3|Participant Flow|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277613|NCT00957528|P2|Participant Flow|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277614|NCT00957528|P1|Participant Flow|Placebo|Weekly placebo treatment for a duration of 5 months.
277615|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277616|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277617|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277618|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277619|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277620|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277621|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277622|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277623|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277624|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277625|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277626|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277627|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277628|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277629|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277630|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277631|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277632|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
277633|NCT00957528|E3|Reported Event|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
277634|NCT00957528|E2|Reported Event|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
277635|NCT00957528|E1|Reported Event|Placebo|Weekly placebo treatment for a duration of 5 months.
277636|NCT00957424|B1|Baseline|Overall|Single-armed study
277637|NCT00957424|P1|Participant Flow|Noncombusted Nicotine Product With Informational Intervention|Single-armed study
277638|NCT00957424|O1|Outcome|Overall|Single-armed study
277639|NCT00957424|O1|Outcome|Overall|Single-armed study
277640|NCT00957424|O1|Outcome|Overall|Single-armed study
277641|NCT00957424|O1|Outcome|Overall|Single-armed study
277642|NCT00957424|E1|Reported Event|Overall|Single-armed study
277643|NCT00957372|B4|Baseline|Total|Total of all reporting groups
277644|NCT00957372|B3|Baseline|Placebo|"placebo~placebo : once daily placebo comparator"
277645|NCT00957372|B2|Baseline|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
277646|NCT00957372|B1|Baseline|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
277647|NCT00957372|P4|Participant Flow|Open-label Extension (Part II)|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277648|NCT00957372|P3|Participant Flow|Placebo|"placebo~placebo : once daily placebo comparator"
277649|NCT00957372|P2|Participant Flow|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
277650|NCT00957372|P1|Participant Flow|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
277651|NCT00957372|O7|Outcome|TEAE Leading to Death|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277652|NCT00957372|O6|Outcome|Treatment Emergent Serious Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277653|NCT00957372|O5|Outcome|TEAE Leading to Discontinuation From the Study|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277707|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277654|NCT00957372|O4|Outcome|Treatment-related Treatment-emergent Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277655|NCT00957372|O3|Outcome|TEAE With Onset After the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277656|NCT00957372|O2|Outcome|TEAE With Onset Within the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277657|NCT00957372|O1|Outcome|TEAE|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
277658|NCT00957372|O3|Outcome|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
277659|NCT00957372|O2|Outcome|ESL 800 mg|400 mg active substance tablets were supplied
277660|NCT00957372|O1|Outcome|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied.
277661|NCT00957372|E4|Reported Event|Open-label Extension (Part II)|ESL dose taken; Starting at 800 mg once daily, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg once daily or up to a maximum of 1200 mg once daily.
277662|NCT00957372|E3|Reported Event|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
277663|NCT00957372|E2|Reported Event|ESL 800 mg|400 mg active substance tablets were supplied
277664|NCT00957372|E1|Reported Event|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied
277665|NCT00957333|B1|Baseline|Case|"ketamine + Cystitis~ketamine"
277666|NCT00957333|P1|Participant Flow|Case|"ketamine + Cystitis~ketamine"
277667|NCT00957333|O1|Outcome|Case|"ketamine + Cystitis~ketamine"
277668|NCT00957333|E1|Reported Event|Case|"ketamine + Cystitis~ketamine"
277669|NCT00957268|B6|Baseline|Total|Total of all reporting groups
277670|NCT00957268|B5|Baseline|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277671|NCT00957268|B4|Baseline|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277672|NCT00957268|B3|Baseline|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277673|NCT00957268|B2|Baseline|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277674|NCT00957268|B1|Baseline|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277675|NCT00957268|P5|Participant Flow|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277676|NCT00957268|P4|Participant Flow|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277677|NCT00957268|P3|Participant Flow|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277678|NCT00957268|P2|Participant Flow|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277679|NCT00957268|P1|Participant Flow|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277680|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277681|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277682|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277683|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277684|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277685|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277686|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277687|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277688|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277689|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277690|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277691|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277692|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277693|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277694|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277695|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277696|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277697|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277698|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277699|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277700|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277701|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277702|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277703|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277704|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277705|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277706|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277708|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277709|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277710|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277711|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277712|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277713|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277714|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277715|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277716|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277717|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277718|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277719|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277720|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277721|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277722|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277723|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277724|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277725|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277726|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277727|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277728|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277729|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277730|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277731|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277732|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277733|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277734|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277735|NCT00957268|E5|Reported Event|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277736|NCT00957268|E4|Reported Event|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277737|NCT00957268|E3|Reported Event|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277738|NCT00957268|E2|Reported Event|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
277739|NCT00957268|E1|Reported Event|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
277740|NCT00957242|B3|Baseline|Total|Total of all reporting groups
277741|NCT00957242|B2|Baseline|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
277742|NCT00957242|B1|Baseline|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
277743|NCT00957242|P2|Participant Flow|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
277744|NCT00957242|P1|Participant Flow|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
277745|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277746|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277747|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277748|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277749|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277750|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277751|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277752|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277753|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277754|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277755|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277756|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277757|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277758|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277759|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277760|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277761|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277762|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277763|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277764|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277765|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
277766|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
277767|NCT00957242|O2|Outcome|Warfarin|warfarin sodium titrated to an INR of 2.0-3.0
277769|NCT00957242|E2|Reported Event|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
277770|NCT00957242|E1|Reported Event|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
277771|NCT00957047|B5|Baseline|Total|Total of all reporting groups
277772|NCT00957047|B4|Baseline|Placebo|placebo : once daily placebo comparator
277773|NCT00957047|B3|Baseline|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
277774|NCT00957047|B2|Baseline|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
277775|NCT00957047|B1|Baseline|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
277776|NCT00957047|P5|Participant Flow|ESL - Part II|All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.
277777|NCT00957047|P4|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
277778|NCT00957047|P3|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
277779|NCT00957047|P2|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
277780|NCT00957047|P1|Participant Flow|Placebo|placebo : once daily placebo comparator
277781|NCT00957047|O7|Outcome|TEAE Leading to Death|
277782|NCT00957047|O6|Outcome|Serious TEAE|
277783|NCT00957047|O5|Outcome|TEAE Leading to Discontinuation|
277784|NCT00957047|O4|Outcome|Treatment-related TEAE|
277785|NCT00957047|O3|Outcome|TEAE With Onset After 1st 4 Weeks|
277786|NCT00957047|O2|Outcome|TEAE With Onset Within the 1st 4 Weeks|
277787|NCT00957047|O1|Outcome|TEAE|
277788|NCT00957047|O4|Outcome|Placebo|placebo : once daily placebo comparator
277789|NCT00957047|O3|Outcome|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
277790|NCT00957047|O2|Outcome|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
277791|NCT00957047|O1|Outcome|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
277792|NCT00957047|E5|Reported Event|ESL PART II|All patients in Part II received ESL
277793|NCT00957047|E4|Reported Event|ESL 1200 mg|Tablets; oral route
277794|NCT00957047|E3|Reported Event|ESL 800 mg|Tablets; oral route
277795|NCT00957047|E2|Reported Event|ESL 400 mg|Tablets; oral route
277796|NCT00957047|E1|Reported Event|Placebo|Tablets; oral route
277797|NCT00957034|B4|Baseline|Total|Total of all reporting groups
277798|NCT00957034|B3|Baseline|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277799|NCT00957034|B2|Baseline|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277800|NCT00957034|B1|Baseline|Placebo|placebo patch
277801|NCT00957034|P3|Participant Flow|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277802|NCT00957034|P2|Participant Flow|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277803|NCT00957034|P1|Participant Flow|Placebo|placebo patch
277804|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277805|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277806|NCT00957034|O1|Outcome|Placebo|placebo patch
277807|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277808|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277809|NCT00957034|O1|Outcome|Placebo|placebo patch
277810|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277811|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277812|NCT00957034|O1|Outcome|Placebo|placebo patch
277813|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277814|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277815|NCT00957034|O1|Outcome|Placebo|placebo patch
277816|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277817|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277818|NCT00957034|O1|Outcome|Placebo|placebo patch
277819|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277820|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277821|NCT00957034|O1|Outcome|Placebo|placebo patch
277822|NCT00957034|E3|Reported Event|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
277823|NCT00957034|E2|Reported Event|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
277824|NCT00957034|E1|Reported Event|Placebo|placebo patch
277825|NCT00957021|B1|Baseline|Triathlon® PS Total Knee System|Participants who were not censored from analysis.
277826|NCT00957021|P1|Participant Flow|Triathlon® PS Total Knee System|If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
277827|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
277828|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
277829|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
277830|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
277831|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
278192|NCT00954538|P4|Participant Flow|HE Participants (Part III Only)|HE participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
277832|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
277833|NCT00957021|E1|Reported Event|Triathlon® PS Total Knee System|All non-censored participants who received the Triathlon® PS Total Knee System.
277834|NCT00957008|B5|Baseline|Total|Total of all reporting groups
277835|NCT00957008|B4|Baseline|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
277836|NCT00957008|B3|Baseline|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
277837|NCT00957008|B2|Baseline|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
277838|NCT00957008|B1|Baseline|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
277839|NCT00957008|P4|Participant Flow|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
277840|NCT00957008|P3|Participant Flow|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
277841|NCT00957008|P2|Participant Flow|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
277842|NCT00957008|P1|Participant Flow|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
277843|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
277844|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
277845|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
277846|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
277847|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
277883|NCT00956631|P1|Participant Flow|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
278341|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
277848|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
277849|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
277850|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
277851|NCT00957008|E4|Reported Event|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
277852|NCT00957008|E3|Reported Event|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
277853|NCT00957008|E2|Reported Event|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
277854|NCT00957008|E1|Reported Event|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
277855|NCT00956943|B3|Baseline|Total|Total of all reporting groups
277856|NCT00956943|B2|Baseline|42mg Transdermal Nicotine|
277857|NCT00956943|B1|Baseline|21mg Transdermal Nicotine + Placebo Patch|
277858|NCT00956943|P2|Participant Flow|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
277859|NCT00956943|P1|Participant Flow|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
277860|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
277861|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
277862|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
277863|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
277864|NCT00956943|E2|Reported Event|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
277865|NCT00956943|E1|Reported Event|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
277866|NCT00956839|B4|Baseline|Total|Total of all reporting groups
277867|NCT00956839|B3|Baseline|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
277868|NCT00956839|B2|Baseline|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
277869|NCT00956839|B1|Baseline|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
277870|NCT00956839|P3|Participant Flow|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
277871|NCT00956839|P2|Participant Flow|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
277872|NCT00956839|P1|Participant Flow|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
277873|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
277874|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
277875|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
277876|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
277877|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
277878|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
277879|NCT00956839|E3|Reported Event|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
277880|NCT00956839|E2|Reported Event|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
277881|NCT00956839|E1|Reported Event|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
277882|NCT00956631|B1|Baseline|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
277884|NCT00956631|O1|Outcome|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
277885|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous lumbar decompression with the mild device kit.
277886|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous decompression with the mild device kit.
277887|NCT00956631|E1|Reported Event|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
277888|NCT00956592|B3|Baseline|Total|Total of all reporting groups
277889|NCT00956592|B2|Baseline|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
277890|NCT00956592|B1|Baseline|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
277891|NCT00956592|P2|Participant Flow|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
277892|NCT00956592|P1|Participant Flow|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
277893|NCT00956592|O2|Outcome|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
277894|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
277895|NCT00956592|E2|Reported Event|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
277896|NCT00956592|E1|Reported Event|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
277897|NCT00956540|B5|Baseline|Total|Total of all reporting groups
277898|NCT00956540|B4|Baseline|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
277899|NCT00956540|B3|Baseline|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
277900|NCT00956540|B2|Baseline|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
277901|NCT00956540|B1|Baseline|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
277902|NCT00956540|P4|Participant Flow|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
277903|NCT00956540|P3|Participant Flow|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
277904|NCT00956540|P2|Participant Flow|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
277905|NCT00956540|P1|Participant Flow|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
277906|NCT00956540|O4|Outcome|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
277907|NCT00956540|O3|Outcome|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
277908|NCT00956540|O2|Outcome|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
277909|NCT00956540|O1|Outcome|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
277910|NCT00956540|E4|Reported Event|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
277911|NCT00956540|E3|Reported Event|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
277912|NCT00956540|E2|Reported Event|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
277913|NCT00956540|E1|Reported Event|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
277914|NCT00956293|B3|Baseline|Total|Total of all reporting groups
277915|NCT00956293|B2|Baseline|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277916|NCT00956293|B1|Baseline|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277917|NCT00956293|P3|Participant Flow|Pre-randomized Group|Participants, who met BL1 eligibility, were enrolled into the study.
277918|NCT00956293|P2|Participant Flow|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277919|NCT00956293|P1|Participant Flow|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277920|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277921|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277922|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277923|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277924|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277925|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277926|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277927|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277928|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277929|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277930|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277931|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277932|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277933|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277934|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277964|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
277935|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277936|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277937|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277938|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277939|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277940|NCT00956293|E2|Reported Event|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
277941|NCT00956293|E1|Reported Event|Control Goup|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
277942|NCT00956254|B1|Baseline|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277943|NCT00956254|P1|Participant Flow|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277944|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277945|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277946|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277947|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277948|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277949|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277950|NCT00956254|E2|Reported Event|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277951|NCT00956254|E1|Reported Event|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
277952|NCT00956020|B1|Baseline|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277953|NCT00956020|P1|Participant Flow|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277954|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277955|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277956|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277957|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277958|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277959|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277960|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277961|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277962|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
277963|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
280066|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
277965|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277966|NCT00956020|E1|Reported Event|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
277967|NCT00955955|B4|Baseline|Total|Total of all reporting groups
277968|NCT00955955|B3|Baseline|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
277969|NCT00955955|B2|Baseline|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
277970|NCT00955955|B1|Baseline|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
277971|NCT00955955|P3|Participant Flow|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
277972|NCT00955955|P2|Participant Flow|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
277973|NCT00955955|P1|Participant Flow|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
277974|NCT00955955|O4|Outcome|Adjunct Placebo Phase II|Patients received placebo for the second 4 weeks of the study. Patients who received placebo in phase 2 also received it in phase 1.
277975|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase II|Patients received Deplin for 4 weeks. Patients who received Deplin in the second phase of the study may or may not have received it in phase 1.
277976|NCT00955955|O2|Outcome|Adjunct Placebo Phase I|Patients who received placebo for 4 weeks.
277977|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase I|Patients who received Deplin (L-methylfolate) for 4 weeks
277978|NCT00955955|O6|Outcome|Pooled Placebo|Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
277979|NCT00955955|O5|Outcome|Pooled Deplin|Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
277980|NCT00955955|O4|Outcome|Adjunct Placebo Phase 2|Patients in this group received placebo in both phases of the study for a total of 8 weeks,
277981|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 2|Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks. Patients who receive Deplin in phase 2 may or may not have received Deplin in phase 1.
277982|NCT00955955|O2|Outcome|Adjunct Placebo Phase 1|Participants will receive placebo for the first 4 weeks
277983|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 1|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
277984|NCT00955955|E2|Reported Event|Placebo|Adverse events for participants who received placebo during the study.
277985|NCT00955955|E1|Reported Event|Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
277986|NCT00955916|B1|Baseline|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
277987|NCT00955916|P1|Participant Flow|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
277988|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
277989|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
277990|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
278016|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
277991|NCT00955916|E1|Reported Event|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
277992|NCT00955825|B3|Baseline|Total|Total of all reporting groups
277993|NCT00955825|B2|Baseline|Placebo|Placebo tablet
277994|NCT00955825|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
277995|NCT00955825|P2|Participant Flow|Placebo|Placebo tablet
277996|NCT00955825|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
277997|NCT00955825|O2|Outcome|Placebo|Placebo tablet
277998|NCT00955825|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
277999|NCT00955825|E2|Reported Event|Placebo|Placebo tablet
278000|NCT00955825|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
278001|NCT00955747|B3|Baseline|Total|Total of all reporting groups
278002|NCT00955747|B2|Baseline|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
278003|NCT00955747|B1|Baseline|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
278004|NCT00955747|P2|Participant Flow|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
278005|NCT00955747|P1|Participant Flow|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
278006|NCT00955747|O2|Outcome|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
278007|NCT00955747|O1|Outcome|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
278008|NCT00955747|E2|Reported Event|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
278009|NCT00955747|E1|Reported Event|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
278010|NCT00955721|B3|Baseline|Total|Total of all reporting groups
278011|NCT00955721|B2|Baseline|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278012|NCT00955721|B1|Baseline|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278013|NCT00955721|P2|Participant Flow|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278014|NCT00955721|P1|Participant Flow|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278015|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278107|NCT00955110|O3|Outcome|Oxymorphone ER 30 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg.
278108|NCT00955110|O2|Outcome|Oxymorphone ER 15 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg.
278017|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278018|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278019|NCT00955721|E2|Reported Event|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278020|NCT00955721|E1|Reported Event|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
278021|NCT00955617|B1|Baseline|All Patients|All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
278022|NCT00955617|P2|Participant Flow|Gadovist Then Dotarem|Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
278023|NCT00955617|P1|Participant Flow|Dotarem Then Gadovist|Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)
278024|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
278025|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
278026|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
278027|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
278028|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
278029|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
278030|NCT00955617|E2|Reported Event|Gadovist MRA|Patients who received a Gadovist enhanced-MRA
278031|NCT00955617|E1|Reported Event|Dotarem MRA|Patients who received a Dotarem enhanced-MRA
278032|NCT00955513|B4|Baseline|Total|Total of all reporting groups
278033|NCT00955513|B3|Baseline|Placebo. Applied 3 Times a Day.|placebo
278034|NCT00955513|B2|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
278035|NCT00955513|B1|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
278036|NCT00955513|P3|Participant Flow|Placebo. Applied 3 Times a Day.|placebo
278037|NCT00955513|P2|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
278038|NCT00955513|P1|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
278039|NCT00955513|O3|Outcome|Placebo. Applied 3 Times a Day.|placebo
278040|NCT00955513|O2|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
278041|NCT00955513|O1|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
278042|NCT00955513|E3|Reported Event|Placebo. Applied 3 Times a Day.|placebo
278043|NCT00955513|E2|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
278044|NCT00955513|E1|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
278045|NCT00955474|B3|Baseline|Total|Total of all reporting groups
278046|NCT00955474|B2|Baseline|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
278047|NCT00955474|B1|Baseline|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
278048|NCT00955474|P2|Participant Flow|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
278049|NCT00955474|P1|Participant Flow|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
278050|NCT00955474|O2|Outcome|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
278051|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
278052|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
278053|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
278054|NCT00955474|E2|Reported Event|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
278055|NCT00955474|E1|Reported Event|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
278056|NCT00955357|B3|Baseline|Total|Total of all reporting groups
278057|NCT00955357|B2|Baseline|Later-Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278058|NCT00955357|B1|Baseline|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278059|NCT00955357|P2|Participant Flow|Later Add-on|"Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278109|NCT00955110|O1|Outcome|Placebo|Subjects received a single oral dose (1 capsule) of placebo.
278342|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278060|NCT00955357|P1|Participant Flow|First Add-on|"Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278061|NCT00955357|O2|Outcome|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278062|NCT00955357|O1|Outcome|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278063|NCT00955357|E2|Reported Event|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278064|NCT00955357|E1|Reported Event|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
278065|NCT00955305|B3|Baseline|Total|Total of all reporting groups
278066|NCT00955305|B2|Baseline|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278067|NCT00955305|B1|Baseline|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278068|NCT00955305|P2|Participant Flow|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278069|NCT00955305|P1|Participant Flow|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278070|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278071|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278072|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278073|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278074|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278075|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278545|NCT00953407|P3|Participant Flow|Etafilcon A|Etafilcon A contact lens
278076|NCT00955305|E2|Reported Event|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
278077|NCT00955305|E1|Reported Event|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
278078|NCT00955279|B4|Baseline|Total|Total of all reporting groups
278079|NCT00955279|B3|Baseline|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278080|NCT00955279|B2|Baseline|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278081|NCT00955279|B1|Baseline|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278082|NCT00955279|P3|Participant Flow|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278083|NCT00955279|P2|Participant Flow|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278084|NCT00955279|P1|Participant Flow|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278085|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278086|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278087|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278088|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278089|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278090|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278091|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278092|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278093|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278094|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278095|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278096|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278097|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278098|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278099|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278100|NCT00955279|E3|Reported Event|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
278101|NCT00955279|E2|Reported Event|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
278102|NCT00955279|E1|Reported Event|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
278103|NCT00955110|B1|Baseline|All Subjects Randomized to Treatment Phase|Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
278104|NCT00955110|P1|Participant Flow|All Subjects|"Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.~All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones."
278105|NCT00955110|O5|Outcome|Oxycodone CR 60 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg.
278106|NCT00955110|O4|Outcome|Oxycodone CR 30 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg.
278546|NCT00953407|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
278110|NCT00955110|E5|Reported Event|Treatment Phase Oxycodone CR 60 mg|Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
278111|NCT00955110|E4|Reported Event|Treatment Phase Oxycodone CR 30mg|Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
278112|NCT00955110|E3|Reported Event|Treatment Phase Oxymorphone ER 30mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
278113|NCT00955110|E2|Reported Event|Treatment Phase Oxymorphone ER 15 mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
278114|NCT00955110|E1|Reported Event|Treatment Phase Placebo|Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose.
278115|NCT00955032|B3|Baseline|Total|Total of all reporting groups
278116|NCT00955032|B2|Baseline|Sham Treatment|Participants in this group did not receive rTMS treatment.
278117|NCT00955032|B1|Baseline|rTMS Treatment|Participants in this group received rTMS treatment.
278118|NCT00955032|P2|Participant Flow|Sham Treatment|Participants in this group did not receive rTMS treatment.
278119|NCT00955032|P1|Participant Flow|rTMS Treatment|Participants in this group received rTMS treatment.
278120|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
278121|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
278122|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received sham treatment.
278123|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
278124|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
278125|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
278126|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received Sham tx.
278127|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
278128|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
278129|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
278130|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed prior to receiving Sham treatment.
278131|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group received were assessed prior to receiving rTMS treatment.
278132|NCT00955032|O4|Outcome|Sham Post Tx (Immediate)|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
278133|NCT00955032|O3|Outcome|rTMS Post TX (Immediate)|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
278134|NCT00955032|O2|Outcome|Sham Pre TX|Participants in this group were assessed before sham treatment.
278135|NCT00955032|O1|Outcome|rTMS Pre TX|Participants in this group were assessed prior to rTMS treatment.
278136|NCT00955032|E2|Reported Event|Sham Treatment|Participants in this group did not receive rTMS treatment.
278137|NCT00955032|E1|Reported Event|rTMS Treatment|Participants in this group received rTMS treatment.
278138|NCT00954993|B1|Baseline|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
278139|NCT00954993|P1|Participant Flow|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
278140|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
278141|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
278142|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
278143|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
278144|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
278145|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
278146|NCT00954993|E2|Reported Event|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
278147|NCT00954993|E1|Reported Event|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
278148|NCT00954941|B3|Baseline|Total|Total of all reporting groups
278191|NCT00954538|P5|Participant Flow|AD Participants (Part III Only)|AD participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
278343|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278149|NCT00954941|B2|Baseline|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
278150|NCT00954941|B1|Baseline|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
278151|NCT00954941|P2|Participant Flow|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
278152|NCT00954941|P1|Participant Flow|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
278153|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
278154|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
278155|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
278156|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
278157|NCT00954941|E2|Reported Event|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
278158|NCT00954941|E1|Reported Event|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
278159|NCT00954915|B1|Baseline|Teplizumab|Anti CD-3 monoclonal antibody
278160|NCT00954915|P1|Participant Flow|Teplizumab|Anti CD-3 monoclonal antibody
278161|NCT00954915|O1|Outcome|Teplizumab|anti-CD3 monoclonal antibody
278162|NCT00954915|E1|Reported Event|Teplizumab|Anti CD-3 monoclonal antibody
278163|NCT00954824|B1|Baseline|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
278164|NCT00954824|P1|Participant Flow|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
278165|NCT00954824|O1|Outcome|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
278166|NCT00954824|E1|Reported Event|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
278167|NCT00954733|B1|Baseline|All Participants|All participants in the study
278168|NCT00954733|P1|Participant Flow|All Participants|All participants undergoing surgery
278169|NCT00954733|O1|Outcome|All Participants|All participants undergoing surgery
278170|NCT00954733|E1|Reported Event|All Participants|All participants undergoing surgery
278171|NCT00954707|B1|Baseline|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278172|NCT00954707|P1|Participant Flow|All Enrolled Subjects|Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
278173|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278547|NCT00953407|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
278174|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278175|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278176|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278177|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278178|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278179|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278180|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278181|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278182|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278183|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278184|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278185|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278186|NCT00954707|E1|Reported Event|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
278187|NCT00954538|B3|Baseline|Total|Total of all reporting groups
278188|NCT00954538|B2|Baseline|AD Participants (Part II/III)|This group includes AD participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of brain
278189|NCT00954538|B1|Baseline|Healthy Participants (Part I) + HE Participants (Part II/III)|This group includes Healthy participants (Part I) and HE participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
278190|NCT00954538|P6|Participant Flow|HE Participants (Part II + III)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II) / HE Participants who completed Part II could receive a second IV dose of ~150 MBq [18F]MK-3328 in Part III; this dose was followed by PET imaging of the brain
278548|NCT00953407|O5|Outcome|Hilafilcon B|Hilafilcon B contact lens
278193|NCT00954538|P3|Participant Flow|Alzheimer's Disease (AD) Participants (Part II Only)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
278194|NCT00954538|P2|Participant Flow|Healthy Elderly (HE) Participants (Part II Only)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
278195|NCT00954538|P1|Participant Flow|Healthy Participants (Part I Only)|Healthy participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by Positron Emission Tomography (PET) imaging of the whole body (Part I)
278196|NCT00954538|O2|Outcome|HE Participants (Part III)|HE participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
278197|NCT00954538|O1|Outcome|AD Participants (Part III)|AD participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
278198|NCT00954538|O2|Outcome|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
278199|NCT00954538|O1|Outcome|AD Participants (Part II)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
278200|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
278201|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
278202|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
278203|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
278204|NCT00954538|E1|Reported Event|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
278205|NCT00954512|B7|Baseline|Total|Total of all reporting groups
278206|NCT00954512|B6|Baseline|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
278207|NCT00954512|B5|Baseline|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278208|NCT00954512|B4|Baseline|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278209|NCT00954512|B3|Baseline|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278210|NCT00954512|B2|Baseline|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278211|NCT00954512|B1|Baseline|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
278212|NCT00954512|P6|Participant Flow|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
278213|NCT00954512|P5|Participant Flow|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278214|NCT00954512|P4|Participant Flow|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278215|NCT00954512|P3|Participant Flow|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278216|NCT00954512|P2|Participant Flow|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278217|NCT00954512|P1|Participant Flow|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
278218|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
278219|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278220|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278549|NCT00953407|O4|Outcome|Omafilcon A|Omafilcon A contact lens
278221|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278222|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278223|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
278224|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
278225|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278226|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278227|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278228|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278229|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
278230|NCT00954512|E5|Reported Event|Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
278231|NCT00954512|E4|Reported Event|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278232|NCT00954512|E3|Reported Event|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
278233|NCT00954512|E2|Reported Event|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
278234|NCT00954512|E1|Reported Event|Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 followed by once-weekly doses of 250 mg/m^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
278235|NCT00954447|B3|Baseline|Total|Total of all reporting groups
278236|NCT00954447|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278237|NCT00954447|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278238|NCT00954447|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278239|NCT00954447|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278240|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278241|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278301|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278242|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278243|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278244|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278245|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278246|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278247|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278248|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278249|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278250|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278251|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278252|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278253|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278254|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278255|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278256|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278257|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278258|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278550|NCT00953407|O3|Outcome|Etafilcon A|Etafilcon A contact lens
278259|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278260|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278261|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278262|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278263|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278264|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278265|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278266|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278267|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278268|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278269|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278270|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278271|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278272|NCT00954447|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278273|NCT00954447|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
278274|NCT00954421|B1|Baseline|All Subjects|All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
278275|NCT00954421|P1|Participant Flow|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
278339|NCT00953927|P1|Participant Flow|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278551|NCT00953407|O2|Outcome|Narafilcon A|Narafilcon A contact lens
278276|NCT00954421|O2|Outcome|TRS Scale Vo Only on vs. Vim Only on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
278277|NCT00954421|O1|Outcome|TRS Scale Both Off vs Both on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Both OFF- Both On) at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
278278|NCT00954421|O1|Outcome|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
278279|NCT00954421|E1|Reported Event|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
278280|NCT00954356|B3|Baseline|Total|Total of all reporting groups
278281|NCT00954356|B2|Baseline|Placebo|5 x matching placebo capsules (administered as a single dose)
278282|NCT00954356|B1|Baseline|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
278283|NCT00954356|P2|Participant Flow|Placebo|5 x matching placebo capsules (administered as a single dose)
278284|NCT00954356|P1|Participant Flow|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
278285|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278286|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278287|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278288|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278289|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278290|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278291|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278292|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278293|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278294|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278295|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278296|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278297|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278298|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278299|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278300|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278340|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278302|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278303|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278304|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278305|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278306|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278307|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278308|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
278309|NCT00954356|E2|Reported Event|Placebo|5 x matching placebo capsules (administered as a single dose)
278310|NCT00954356|E1|Reported Event|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
278311|NCT00954187|B3|Baseline|Total|Total of all reporting groups
278312|NCT00954187|B2|Baseline|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
278313|NCT00954187|B1|Baseline|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
278314|NCT00954187|P2|Participant Flow|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
278315|NCT00954187|P1|Participant Flow|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
278316|NCT00954187|O2|Outcome|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
278317|NCT00954187|O1|Outcome|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
278318|NCT00954187|E2|Reported Event|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
278319|NCT00954187|E1|Reported Event|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
278320|NCT00954122|B1|Baseline|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
278321|NCT00954122|P1|Participant Flow|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
278322|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278323|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278324|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278325|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278326|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278327|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278328|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
278329|NCT00954122|E1|Reported Event|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
278330|NCT00954109|B1|Baseline|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
278331|NCT00954109|P1|Participant Flow|Exercise|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
278332|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
278333|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
278334|NCT00954109|E1|Reported Event|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
278335|NCT00953927|B3|Baseline|Total|Total of all reporting groups
278336|NCT00953927|B2|Baseline|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278337|NCT00953927|B1|Baseline|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278338|NCT00953927|P2|Participant Flow|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278552|NCT00953407|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
278344|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278345|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278346|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278347|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278348|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278349|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278350|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278351|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278352|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278353|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278354|NCT00953927|E2|Reported Event|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
278355|NCT00953927|E1|Reported Event|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
278356|NCT00953862|B1|Baseline|Treatment|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
278357|NCT00953862|P1|Participant Flow|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
278358|NCT00953862|O1|Outcome|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
278359|NCT00953862|O1|Outcome|Atomoxetine Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
278360|NCT00953862|O1|Outcome|Atomoxetine Arm|Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
278394|NCT00953719|P2|Participant Flow|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278395|NCT00953719|P1|Participant Flow|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278553|NCT00953407|E5|Reported Event|Hilafilcon B|Hilafilcon B contact lens
278361|NCT00953862|E1|Reported Event|Treatment Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
278362|NCT00953849|B5|Baseline|Total|Total of all reporting groups
278363|NCT00953849|B4|Baseline|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
278364|NCT00953849|B3|Baseline|Arm 3: Celecoxib Plus Calcitriol|Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
278365|NCT00953849|B2|Baseline|Arm 2: Calcitriol|Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
278366|NCT00953849|B1|Baseline|Arm 1: Celecoxib|"Celecoxib:~Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery"
278367|NCT00953849|P4|Participant Flow|Arm 4: No Treatment|no treatment prior to surgery
278368|NCT00953849|P3|Participant Flow|Arm 3: Celecoxib Plus Calcitriol|Treatment with Celecoxib + Calcitriol
278369|NCT00953849|P2|Participant Flow|Arm 2: Calcitriol|Treatment with Calcitriol
278370|NCT00953849|P1|Participant Flow|Arm 1: Celecoxib|Treatment with Celecoxib
278371|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
278372|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
278373|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
278374|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
278375|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
278376|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
278377|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
278378|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
278379|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
278380|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
278381|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
278382|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
278383|NCT00953849|O4|Outcome|Arm 4: No Treatment|no treatment prior to surgery
278384|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"Treatment with Celecoxib plus Calcitriol prior to surgery.~Celecoxib plus Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)"
278385|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"Treatment with Calcitriol prior to surgery~Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)"
278386|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"Celecoxib treatment prior to surgery~Celecoxib: Celecoxib (400 mg twice daily)"
278387|NCT00953849|E4|Reported Event|Arm 4: No Treatment|oral cancer patients receiving no treatment prior to surgery
278388|NCT00953849|E3|Reported Event|Arm 3: Celecoxib Plus Calcitriol|oral cancer patients receiving Celecoxib + Calcitriol prior to surgery
278389|NCT00953849|E2|Reported Event|Arm 2: Calcitriol|oral cancer patients receiving Calcitriol prior to surgery
278390|NCT00953849|E1|Reported Event|Arm 1: Celecoxib|oral cancer patients receiving Celecoxib prior to surgery
278391|NCT00953719|B3|Baseline|Total|Total of all reporting groups
278392|NCT00953719|B2|Baseline|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278393|NCT00953719|B1|Baseline|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278429|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278396|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278397|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278398|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278399|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278400|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278401|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278402|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278403|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278404|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278405|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278406|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278407|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278408|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278409|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278410|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278411|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278412|NCT00953719|E2|Reported Event|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
278413|NCT00953719|E1|Reported Event|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
278414|NCT00953706|B3|Baseline|Total|Total of all reporting groups
278415|NCT00953706|B2|Baseline|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278416|NCT00953706|B1|Baseline|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
278417|NCT00953706|P4|Participant Flow|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278418|NCT00953706|P3|Participant Flow|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278419|NCT00953706|P2|Participant Flow|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278420|NCT00953706|P1|Participant Flow|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
278421|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278422|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278423|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278424|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278425|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278426|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278427|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278428|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278430|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278431|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278432|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278433|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278434|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278435|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278436|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278437|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278438|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278439|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278440|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278441|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278442|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278443|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278444|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278445|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278446|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278447|NCT00953706|E4|Reported Event|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278448|NCT00953706|E3|Reported Event|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
278449|NCT00953706|E2|Reported Event|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278450|NCT00953706|E1|Reported Event|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
278451|NCT00953680|B1|Baseline|All Participants|All randomized patients
278452|NCT00953680|P2|Participant Flow|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278453|NCT00953680|P1|Participant Flow|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278454|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278455|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278456|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278457|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278458|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278459|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278460|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278461|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278462|NCT00953680|E2|Reported Event|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
278463|NCT00953680|E1|Reported Event|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
278464|NCT00953667|B1|Baseline|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
278465|NCT00953667|P1|Participant Flow|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
278466|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
278544|NCT00953407|P4|Participant Flow|Omafilcon A|Omafilcon A contact lens
278467|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
278468|NCT00953667|E1|Reported Event|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
278469|NCT00953654|B4|Baseline|Total|Total of all reporting groups
278470|NCT00953654|B3|Baseline|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
278471|NCT00953654|B2|Baseline|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
278472|NCT00953654|B1|Baseline|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
278473|NCT00953654|P3|Participant Flow|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
278474|NCT00953654|P2|Participant Flow|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
278475|NCT00953654|P1|Participant Flow|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
278476|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
278477|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
278478|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
278479|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
278480|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
278481|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
278482|NCT00953654|E3|Reported Event|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
278483|NCT00953654|E2|Reported Event|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
278484|NCT00953654|E1|Reported Event|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
278485|NCT00953615|B1|Baseline|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
278486|NCT00953615|P1|Participant Flow|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
278487|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
278488|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
278489|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
278490|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
278491|NCT00953615|E1|Reported Event|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
278492|NCT00953524|B5|Baseline|Total|Total of all reporting groups
278493|NCT00953524|B4|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278494|NCT00953524|B3|Baseline|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278495|NCT00953524|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278496|NCT00953524|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278497|NCT00953524|P4|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278498|NCT00953524|P3|Participant Flow|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278499|NCT00953524|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278500|NCT00953524|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278501|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278502|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278503|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278504|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278505|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278506|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278507|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278508|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278509|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278510|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278511|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278512|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278513|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278514|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278515|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278516|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278517|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278518|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278519|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278520|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278521|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278522|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278523|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278524|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278525|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278526|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278527|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278528|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278529|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278530|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278531|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278532|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278533|NCT00953524|E4|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278534|NCT00953524|E3|Reported Event|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278535|NCT00953524|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
278536|NCT00953524|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
278537|NCT00953407|B6|Baseline|Total|Total of all reporting groups
278538|NCT00953407|B5|Baseline|Hilafilcon B|Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis
278539|NCT00953407|B4|Baseline|Omafilcon A|Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis
278540|NCT00953407|B3|Baseline|Etafilcon A|Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis
278541|NCT00953407|B2|Baseline|Narafilcon A|Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis
278542|NCT00953407|B1|Baseline|Nelfilcon A|Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis
278543|NCT00953407|P5|Participant Flow|Hilafilcon B|Hilafilcon B contact lens
278556|NCT00953407|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
278557|NCT00953407|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
278558|NCT00953329|B1|Baseline|Group 1|
278559|NCT00953329|P1|Participant Flow|Alefacept Treated|
278560|NCT00953329|O1|Outcome|Alefacept|50 mg
278561|NCT00953329|E1|Reported Event|Group 1|
278562|NCT00953290|B1|Baseline|Treated And Untreated Thigh|Treated and untreated arms (left and right thighs) on the same subject.
278563|NCT00953290|P1|Participant Flow|Treated and Untreated Thigh|Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
278564|NCT00953290|O1|Outcome|Treated and Untreated Mid Thigh|Treated and untreated arms (left and right thigh) on the same subject
278565|NCT00953290|O1|Outcome|Treated Thigh|
278566|NCT00953290|O1|Outcome|Treated and Untreated Thigh|
278567|NCT00953290|O1|Outcome|Treated and Untreated Upper Thigh|Treated and untreated arms (left and right thigh) on the same participant
278568|NCT00953290|E1|Reported Event|Treated Thigh|
278569|NCT00953225|B3|Baseline|Total|Total of all reporting groups
278570|NCT00953225|B2|Baseline|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
278571|NCT00953225|B1|Baseline|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
278572|NCT00953225|P2|Participant Flow|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
278573|NCT00953225|P1|Participant Flow|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
278574|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
278575|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
278576|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
278577|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
278578|NCT00953225|E2|Reported Event|Arm 2|"Placebo daily for one year~Placebo daily for one year: Placebo"
278579|NCT00953225|E1|Reported Event|Arm 1|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
278580|NCT00953160|B1|Baseline|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278581|NCT00953160|P1|Participant Flow|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278582|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278583|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278584|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278585|NCT00953160|E1|Reported Event|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
278586|NCT00953147|B4|Baseline|Total|Total of all reporting groups
278587|NCT00953147|B3|Baseline|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278588|NCT00953147|B2|Baseline|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278589|NCT00953147|B1|Baseline|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278590|NCT00953147|P3|Participant Flow|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278591|NCT00953147|P2|Participant Flow|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278592|NCT00953147|P1|Participant Flow|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278593|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278594|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278595|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278596|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278597|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278598|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278599|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278600|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278601|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278602|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278603|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278604|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
279232|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
278605|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278606|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278607|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278608|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278609|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278610|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278611|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278612|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278613|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278614|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278615|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278616|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278617|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278618|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278619|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278620|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278621|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278622|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278623|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278624|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278625|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278626|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278627|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278628|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278629|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278630|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278631|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278632|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
278633|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
278634|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
278635|NCT00953147|E3|Reported Event|Placebo Once Daily|
278636|NCT00953147|E2|Reported Event|Ciclesonide HFA 160 Mcg Once Daily|
278637|NCT00953147|E1|Reported Event|Ciclesonide HFA 80 Mcg Once Daily|
278638|NCT00953121|B4|Baseline|Total|Total of all reporting groups
278639|NCT00953121|B3|Baseline|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278640|NCT00953121|B2|Baseline|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278680|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
279233|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
278641|NCT00953121|B1|Baseline|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278642|NCT00953121|P3|Participant Flow|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278643|NCT00953121|P2|Participant Flow|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278644|NCT00953121|P1|Participant Flow|Grade IV, No Bevacizumab Failure|"Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4."
278645|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278646|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278647|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278648|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278649|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278650|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278651|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278652|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278653|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278681|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
278682|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
278654|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278655|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278656|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278657|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278658|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278659|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278660|NCT00953121|E3|Reported Event|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278661|NCT00953121|E2|Reported Event|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278662|NCT00953121|E1|Reported Event|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
278663|NCT00953056|B7|Baseline|Total|Total of all reporting groups
278664|NCT00953056|B6|Baseline|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278665|NCT00953056|B5|Baseline|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278666|NCT00953056|B4|Baseline|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
278667|NCT00953056|B3|Baseline|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
278668|NCT00953056|B2|Baseline|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
278669|NCT00953056|B1|Baseline|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
278670|NCT00953056|P6|Participant Flow|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278671|NCT00953056|P5|Participant Flow|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278672|NCT00953056|P4|Participant Flow|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
278673|NCT00953056|P3|Participant Flow|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
278674|NCT00953056|P2|Participant Flow|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
278675|NCT00953056|P1|Participant Flow|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
278676|NCT00953056|O2|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278677|NCT00953056|O1|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278678|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278679|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278683|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
278684|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278685|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278686|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
278687|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
278688|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
278689|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
278690|NCT00953056|E6|Reported Event|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
278691|NCT00953056|E5|Reported Event|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
278692|NCT00953056|E4|Reported Event|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
278693|NCT00953056|E3|Reported Event|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
278694|NCT00953056|E2|Reported Event|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
278695|NCT00953056|E1|Reported Event|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
278696|NCT00953043|B3|Baseline|Total|Total of all reporting groups
278697|NCT00953043|B2|Baseline|Placebo|Subjects randomized to this arm received placebo medication for three days.
278698|NCT00953043|B1|Baseline|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278699|NCT00953043|P2|Participant Flow|Placebo|Subjects randomized to this arm received placebo medication for three days.
278700|NCT00953043|P1|Participant Flow|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278701|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278702|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278703|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278704|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278705|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278706|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278707|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278708|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278709|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278710|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278711|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278712|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278713|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278714|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278715|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
278716|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278717|NCT00953043|E2|Reported Event|Placebo|Subjects randomized to this arm received placebo medication for three days.
278718|NCT00953043|E1|Reported Event|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
278719|NCT00953017|B5|Baseline|Total|Total of all reporting groups
278720|NCT00953017|B4|Baseline|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278721|NCT00953017|B3|Baseline|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278722|NCT00953017|B2|Baseline|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278723|NCT00953017|B1|Baseline|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278724|NCT00953017|P4|Participant Flow|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278725|NCT00953017|P3|Participant Flow|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278726|NCT00953017|P2|Participant Flow|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278727|NCT00953017|P1|Participant Flow|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278728|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278729|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278730|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278731|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278732|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278733|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278734|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278735|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278736|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278737|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278738|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278739|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278740|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278741|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278742|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278743|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
279234|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
278744|NCT00953017|E4|Reported Event|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
278745|NCT00953017|E3|Reported Event|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278746|NCT00953017|E2|Reported Event|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278747|NCT00953017|E1|Reported Event|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
278748|NCT00952848|B1|Baseline|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
278749|NCT00952848|P1|Participant Flow|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
278750|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
278751|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
278752|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
278753|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
278754|NCT00952848|E1|Reported Event|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
278755|NCT00952822|B1|Baseline|Treated Participants|Participants who received at least 1 infusion
278756|NCT00952822|P4|Participant Flow|Pediatrics - 5 mL Then 2 mL|Pediatrics - 5 mL then 2 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
278757|NCT00952822|P3|Participant Flow|Pediatrics - 2 mL Then 5 mL|Pediatrics - 2 mL then 5 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
278758|NCT00952822|P2|Participant Flow|Adolescents/Adults - 5 mL Then 2 mL|Adolescents/Adults - 5 mL then 2 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
278759|NCT00952822|P1|Participant Flow|Adolescents/Adults - 2 mL Then 5 mL|Adolescents/Adults - 2 mL then 5 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
278760|NCT00952822|O4|Outcome|Pediatrics at Least 5 Years of Age - 5 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7)
278761|NCT00952822|O3|Outcome|Pediatrics at Least 5 Years of Age - 2 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7)
278762|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26)
278763|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278764|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
278765|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
278766|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278767|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278768|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278769|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278770|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278771|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278772|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278773|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278774|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278775|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278776|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278777|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278778|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
278779|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
278780|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278781|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278782|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278783|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278784|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
278785|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
278786|NCT00952822|E2|Reported Event|Pediatrics|Participants aged ≥12 to ≤65 years who received at least one infusion
278787|NCT00952822|E1|Reported Event|Adolescents/Adults|Participants aged ≥12 to ≤65 years who received at least one infusion
278788|NCT00952731|B3|Baseline|Total|Total of all reporting groups
278789|NCT00952731|B2|Baseline|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278790|NCT00952731|B1|Baseline|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278791|NCT00952731|P2|Participant Flow|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278792|NCT00952731|P1|Participant Flow|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278793|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278794|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278795|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278796|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278797|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278798|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278799|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278800|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278801|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278802|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278803|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278804|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278805|NCT00952731|E2|Reported Event|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
278806|NCT00952731|E1|Reported Event|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
278807|NCT00952705|B4|Baseline|Total|Total of all reporting groups
278808|NCT00952705|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278884|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278809|NCT00952705|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278810|NCT00952705|B1|Baseline|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278811|NCT00952705|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278812|NCT00952705|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278813|NCT00952705|P1|Participant Flow|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278814|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278815|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278816|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278817|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278818|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278819|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278820|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278821|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278822|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278823|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278824|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278825|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278826|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278885|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278933|NCT00952484|B2|Baseline|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
278827|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278828|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278829|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278830|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278831|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278832|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278833|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278834|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278835|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278836|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278837|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278838|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278839|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278840|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278841|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278842|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278843|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278844|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278845|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278846|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278847|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278848|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278849|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278850|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278851|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278852|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278853|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278854|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278855|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278856|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278857|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278858|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278859|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278860|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278861|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278932|NCT00952484|B3|Baseline|Historical Control|De-identified historical controls selected from a natural history database of patients with HPP.
278862|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278863|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278864|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278865|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278866|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278867|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278868|NCT00952705|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
278869|NCT00952705|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
278870|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
278871|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278872|NCT00952705|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
278873|NCT00952705|E1|Reported Event|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
278874|NCT00952653|B1|Baseline|DVS SR 50 mg, Midazolam 4 mg|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278875|NCT00952653|P1|Participant Flow|DVS SR 50 mg, Midazolam 4 mg|Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278876|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278877|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278878|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278879|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278880|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278881|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278882|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278883|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
279235|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
278886|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278887|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278888|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278889|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278890|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278891|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278892|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278893|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278894|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278895|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278896|NCT00952653|E3|Reported Event|DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)|DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
278897|NCT00952653|E2|Reported Event|DVS SR 50 mg (Period 2 / Day 1 to Day 5)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
278898|NCT00952653|E1|Reported Event|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
278899|NCT00952614|B1|Baseline|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
278900|NCT00952614|P1|Participant Flow|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
278901|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
278902|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide~Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years."
278903|NCT00952614|E1|Reported Event|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
278904|NCT00952588|B3|Baseline|Total|Total of all reporting groups
278905|NCT00952588|B2|Baseline|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278906|NCT00952588|B1|Baseline|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278907|NCT00952588|P2|Participant Flow|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278908|NCT00952588|P1|Participant Flow|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278909|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278910|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278911|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278912|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278913|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278914|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278915|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278916|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278917|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278918|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278919|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278920|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278921|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278922|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278923|NCT00952588|E2|Reported Event|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
278924|NCT00952588|E1|Reported Event|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
278925|NCT00952523|B1|Baseline|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
278926|NCT00952523|P1|Participant Flow|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
278927|NCT00952523|O2|Outcome|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene 0.1% and Benzoyl peroxide 2.5%
278928|NCT00952523|O1|Outcome|Tretinoin Facial Gel|Tretinoin facial gel in a 0.04% Pump
278929|NCT00952523|E2|Reported Event|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
278930|NCT00952523|E1|Reported Event|Tretinoin Facial Gel|Tretinoin facial gel applied once daily in a split face model
278931|NCT00952484|B4|Baseline|Total|Total of all reporting groups
278934|NCT00952484|B1|Baseline|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
278935|NCT00952484|P3|Participant Flow|Historical Control|"De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner’s Hospitals for Children, St. Louis, Missouri.~Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates."
278936|NCT00952484|P2|Participant Flow|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278937|NCT00952484|P1|Participant Flow|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278938|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278939|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278940|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278941|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278942|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278943|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278944|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278945|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278946|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278947|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278948|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
278949|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
278950|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278951|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278952|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278953|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278954|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278955|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278956|NCT00952484|O2|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
278957|NCT00952484|O1|Outcome|Historical Controls|De-identified historical controls selected from a natural history database of patients with HPP.
278958|NCT00952484|E2|Reported Event|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
278959|NCT00952484|E1|Reported Event|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
278960|NCT00952419|B4|Baseline|Total|Total of all reporting groups
278961|NCT00952419|B3|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278962|NCT00952419|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278963|NCT00952419|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278964|NCT00952419|P3|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278965|NCT00952419|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278966|NCT00952419|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278967|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278968|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278969|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278970|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278971|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278972|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278973|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278974|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278975|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278976|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278977|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
279236|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
278978|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278979|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278980|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278981|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278982|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278983|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278984|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278985|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278986|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278987|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278988|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278989|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278990|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278991|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278992|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278993|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278994|NCT00952419|E3|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
278995|NCT00952419|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278996|NCT00952419|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
278997|NCT00952393|B1|Baseline|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
278998|NCT00952393|P1|Participant Flow|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
278999|NCT00952393|O1|Outcome|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
279000|NCT00952393|E1|Reported Event|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
279001|NCT00952367|B1|Baseline|Per-protocol Population|In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279002|NCT00952367|P1|Participant Flow|All Enrolled Participants|Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
279003|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279004|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279005|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279006|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279007|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279008|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279009|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279010|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279011|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279012|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279176|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279013|NCT00952367|E1|Reported Event|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
279014|NCT00952341|B3|Baseline|Total|Total of all reporting groups
279015|NCT00952341|B2|Baseline|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279016|NCT00952341|B1|Baseline|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279017|NCT00952341|P2|Participant Flow|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279018|NCT00952341|P1|Participant Flow|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279019|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279020|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279021|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279022|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279023|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279024|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279025|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279026|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279027|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279028|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279029|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279030|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279031|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279032|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279033|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279034|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279096|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279035|NCT00952341|E2|Reported Event|Placebo, Cycle 1 & Cycle 2|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
279036|NCT00952341|E1|Reported Event|Aprepitant (MK-0869), Cycle 1 & Cycle 2|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
279037|NCT00952289|B3|Baseline|Total|Total of all reporting groups
279038|NCT00952289|B2|Baseline|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279039|NCT00952289|B1|Baseline|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279040|NCT00952289|P2|Participant Flow|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279041|NCT00952289|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
279042|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279043|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279044|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279045|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279046|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279047|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279048|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279049|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279050|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279051|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279052|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279053|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279054|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279055|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279056|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279057|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279230|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279058|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279059|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279060|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279061|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279062|NCT00952289|E2|Reported Event|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
279063|NCT00952289|E1|Reported Event|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
279064|NCT00952276|B6|Baseline|Total|Total of all reporting groups
279065|NCT00952276|B5|Baseline|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279066|NCT00952276|B4|Baseline|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279067|NCT00952276|B3|Baseline|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279068|NCT00952276|B2|Baseline|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279069|NCT00952276|B1|Baseline|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279070|NCT00952276|P5|Participant Flow|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279071|NCT00952276|P4|Participant Flow|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279072|NCT00952276|P3|Participant Flow|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279073|NCT00952276|P2|Participant Flow|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279074|NCT00952276|P1|Participant Flow|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279075|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279076|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279077|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279078|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279079|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279080|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279081|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279082|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279083|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279084|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279085|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279086|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279087|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279088|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279089|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279090|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279091|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279092|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279093|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279094|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279095|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279097|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279098|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279099|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279100|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279101|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279102|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279103|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279104|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279105|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279106|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279107|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279108|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279109|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279110|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279111|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279112|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279113|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279114|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279115|NCT00952276|E5|Reported Event|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
279116|NCT00952276|E4|Reported Event|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
279117|NCT00952276|E3|Reported Event|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
279118|NCT00952276|E2|Reported Event|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
279119|NCT00952276|E1|Reported Event|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
279120|NCT00952211|B3|Baseline|Total|Total of all reporting groups
279121|NCT00952211|B2|Baseline|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
279122|NCT00952211|B1|Baseline|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
279123|NCT00952211|P2|Participant Flow|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
279124|NCT00952211|P1|Participant Flow|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
279125|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
279126|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
279127|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
279128|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
279129|NCT00952211|E2|Reported Event|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
279130|NCT00952211|E1|Reported Event|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
279131|NCT00952133|B3|Baseline|Total|Total of all reporting groups
279132|NCT00952133|B2|Baseline|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
279133|NCT00952133|B1|Baseline|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
279134|NCT00952133|P2|Participant Flow|Palonosetron With Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
279135|NCT00952133|P1|Participant Flow|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
279136|NCT00952133|O2|Outcome|Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
279137|NCT00952133|O1|Outcome|Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
279231|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279138|NCT00952133|O2|Outcome|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
279139|NCT00952133|O1|Outcome|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
279140|NCT00952133|E2|Reported Event|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
279141|NCT00952133|E1|Reported Event|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
279142|NCT00952120|B4|Baseline|Total|Total of all reporting groups
279143|NCT00952120|B3|Baseline|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
279144|NCT00952120|B2|Baseline|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
279145|NCT00952120|B1|Baseline|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
279146|NCT00952120|P3|Participant Flow|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
279147|NCT00952120|P2|Participant Flow|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
279148|NCT00952120|P1|Participant Flow|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
279149|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
279150|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
279151|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
279152|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
279153|NCT00952120|E2|Reported Event|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
279154|NCT00952120|E1|Reported Event|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
279155|NCT00952081|B1|Baseline|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
279156|NCT00952081|P1|Participant Flow|Clevidipine,Brain Tumor,Hypertension|Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
279157|NCT00952081|O1|Outcome|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
279158|NCT00952081|E1|Reported Event|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
279159|NCT00952068|B1|Baseline|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279160|NCT00952068|P1|Participant Flow|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279161|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279162|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279163|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279164|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279165|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279166|NCT00952068|E1|Reported Event|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
279167|NCT00951912|B4|Baseline|Total|Total of all reporting groups
279168|NCT00951912|B3|Baseline|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
279169|NCT00951912|B2|Baseline|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
279170|NCT00951912|B1|Baseline|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
279171|NCT00951912|P3|Participant Flow|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
279172|NCT00951912|P2|Participant Flow|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
279173|NCT00951912|P1|Participant Flow|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
279174|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279175|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279237|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279177|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279178|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279179|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279180|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279181|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279182|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279183|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279184|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279185|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279186|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279187|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279188|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279189|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279190|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279191|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279192|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279193|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279194|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279195|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279196|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279197|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279198|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279199|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279200|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279201|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279202|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279203|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279204|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279205|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279206|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279207|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279208|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279209|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279210|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279211|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279212|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279213|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279214|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279215|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279216|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
279217|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
279218|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
279219|NCT00951912|E3|Reported Event|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
279220|NCT00951912|E2|Reported Event|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
279221|NCT00951912|E1|Reported Event|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
279222|NCT00951899|B3|Baseline|Total|Total of all reporting groups
279223|NCT00951899|B2|Baseline|Placebo|Placebo plus diet and metformin
279224|NCT00951899|B1|Baseline|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279225|NCT00951899|P2|Participant Flow|Placebo|Placebo plus diet and metformin
279226|NCT00951899|P1|Participant Flow|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279227|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279228|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279229|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279238|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279239|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279240|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279241|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279242|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279243|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
279244|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279245|NCT00951899|E2|Reported Event|Placebo|Placebo plus diet and metformin
279246|NCT00951899|E1|Reported Event|Colesevelam|Treatment with colesevelam in addition to metformin and diet
279247|NCT00951821|B3|Baseline|Total|Total of all reporting groups
279248|NCT00951821|B2|Baseline|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
279249|NCT00951821|B1|Baseline|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
279250|NCT00951821|P2|Participant Flow|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
279251|NCT00951821|P1|Participant Flow|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
279252|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
279253|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
279254|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
279255|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
279256|NCT00951821|E2|Reported Event|Adolescent Treatment Only|"Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.~Adolescent treatment only: Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
279257|NCT00951821|E1|Reported Event|Concurrent Treatment|"Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent treatment: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
279258|NCT00951808|B1|Baseline|All Participants|237 subjects enrolled in the feasibility study.
279259|NCT00951808|P3|Participant Flow|Standard Care Observational Cohort|Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).
279260|NCT00951808|P2|Participant Flow|Standard Care Trial Cohort|Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
279261|NCT00951808|P1|Participant Flow|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
279262|NCT00951808|O3|Outcome|Overall|Both adults and children
279263|NCT00951808|O2|Outcome|Children|Age < 18
279264|NCT00951808|O1|Outcome|Adults|Age >= 18
279265|NCT00951808|E1|Reported Event|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
279266|NCT00951665|B7|Baseline|Total|Total of all reporting groups
279267|NCT00951665|B6|Baseline|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
279268|NCT00951665|B5|Baseline|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
279269|NCT00951665|B4|Baseline|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279270|NCT00951665|B3|Baseline|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279271|NCT00951665|B2|Baseline|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279272|NCT00951665|B1|Baseline|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279273|NCT00951665|P6|Participant Flow|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
279274|NCT00951665|P5|Participant Flow|Phase IIa Group A|Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
279275|NCT00951665|P4|Participant Flow|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279276|NCT00951665|P3|Participant Flow|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279277|NCT00951665|P2|Participant Flow|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279278|NCT00951665|P1|Participant Flow|Phase Ib Regimen 1|Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
279279|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279280|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279281|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279282|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279283|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279284|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279285|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279286|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279287|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279288|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279289|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279290|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279291|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279292|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279293|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279294|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279295|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279296|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279297|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279298|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279299|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279300|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279301|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279302|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279303|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279304|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279305|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279306|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279307|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279308|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279309|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
279310|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
279311|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
279312|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
279313|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
279314|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
279315|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279818|NCT00950690|B1|Baseline|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
279316|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279317|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279318|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279319|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
279320|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279321|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279322|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279323|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279324|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
279325|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279326|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279327|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279328|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
279329|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279330|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279331|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279332|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
279333|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279334|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
279335|NCT00951665|O5|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279336|NCT00951665|O4|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279337|NCT00951665|O3|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279338|NCT00951665|O2|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
279339|NCT00951665|O1|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279340|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279341|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279342|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279343|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
279344|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
279345|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
279346|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received of T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab Q3W intravenously.
279347|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279348|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279349|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279350|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279351|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279352|NCT00951665|O2|Outcome|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab 420 mg Q3W intravenously.
279353|NCT00951665|O1|Outcome|Phase IIa Group A|Participants received MTD from Phase Ib i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279354|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279355|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279356|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279357|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279358|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279359|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279360|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279361|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279362|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279363|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279364|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279365|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279463|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279366|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279367|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279368|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279369|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279370|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279371|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279372|NCT00951665|E6|Reported Event|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
279373|NCT00951665|E5|Reported Event|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
279374|NCT00951665|E4|Reported Event|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
279375|NCT00951665|E3|Reported Event|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
279376|NCT00951665|E2|Reported Event|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
279377|NCT00951665|E1|Reported Event|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
279378|NCT00951561|B1|Baseline|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
279379|NCT00951561|P4|Participant Flow|Ibuprofen/Vipon/Vipon/Ibuprofen|
279380|NCT00951561|P3|Participant Flow|Vipon/Ibuprofen/Ibuprofen/Vipon|
279381|NCT00951561|P2|Participant Flow|Ibuprofen/Vipon/Ibuprofen/Vipon|
279382|NCT00951561|P1|Participant Flow|Vipon/Ibuprofen/Vipon/Ibuprofen|Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
279383|NCT00951561|O2|Outcome|Ibuprofen|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
279384|NCT00951561|O1|Outcome|VIPON|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
279385|NCT00951561|E1|Reported Event|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
279386|NCT00951509|B1|Baseline|All Subjects|"Power Mobility Road Test (PMRT): All subjects were asked to complete the real world power mobility evaluation via the PMRT.~Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.~Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment."
279387|NCT00951509|P1|Participant Flow|Participants Who Qualified for the Study|All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
279388|NCT00951509|O5|Outcome|Condition 5|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
279389|NCT00951509|O4|Outcome|Condition 4|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
279390|NCT00951509|O3|Outcome|Condition 3|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
279391|NCT00951509|O2|Outcome|Condition 2|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
279392|NCT00951509|O1|Outcome|Condition 1|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
279393|NCT00951509|E1|Reported Event|Power Mobility Road Test|With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed “Composite score”. A Composite score of 95 % or greater would suggest that the user is a safe driver.
279394|NCT00951483|B3|Baseline|Total|Total of all reporting groups
279395|NCT00951483|B2|Baseline|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
279464|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279396|NCT00951483|B1|Baseline|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279397|NCT00951483|P2|Participant Flow|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
279398|NCT00951483|P1|Participant Flow|Intervention Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279399|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279400|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279401|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279402|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279403|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279404|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279405|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279406|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279407|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279408|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279409|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279410|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279411|NCT00951483|O2|Outcome|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
279412|NCT00951483|O1|Outcome|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279413|NCT00951483|E2|Reported Event|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
279465|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279414|NCT00951483|E1|Reported Event|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
279415|NCT00951379|B3|Baseline|Total|Total of all reporting groups
279416|NCT00951379|B2|Baseline|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279417|NCT00951379|B1|Baseline|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279418|NCT00951379|P2|Participant Flow|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279419|NCT00951379|P1|Participant Flow|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279420|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279421|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279422|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279423|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279424|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279425|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279426|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279427|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279428|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279429|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279430|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279431|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279432|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279433|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279434|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279435|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279436|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279437|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279438|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279439|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279440|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279441|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279442|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279443|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279444|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279445|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279446|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279447|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279448|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279449|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279450|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279451|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279452|NCT00951379|O4|Outcome|Placebo: CRP>5 End of Study|Measure at end of Placebo treatment, approximately 24 weeks
279453|NCT00951379|O3|Outcome|Placebo: CRP> 5 Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
279454|NCT00951379|O2|Outcome|Pioglitazone: CRP>5 End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
279455|NCT00951379|O1|Outcome|Pioglitazone: CRP>5 at Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
279456|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279457|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279458|NCT00951379|E2|Reported Event|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
279459|NCT00951379|E1|Reported Event|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
279460|NCT00951275|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279461|NCT00951275|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions.
279462|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279819|NCT00950690|P1|Participant Flow|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
279466|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279467|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279468|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279469|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279470|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279471|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279472|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279473|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279474|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279475|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279476|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279477|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279478|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279479|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279480|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279481|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279482|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279483|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279484|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279485|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279486|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279487|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279488|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279489|NCT00951275|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
279490|NCT00951171|B3|Baseline|Total|Total of all reporting groups
279491|NCT00951171|B2|Baseline|Standard IUI|Insemination with TOmcat catheter
279492|NCT00951171|B1|Baseline|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
279493|NCT00951171|P2|Participant Flow|Standard IUI|Insemination with TOmcat catheter
279494|NCT00951171|P1|Participant Flow|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
279495|NCT00951171|O2|Outcome|Standard IUI|Insemination with TOmcat catheter
279496|NCT00951171|O1|Outcome|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
279497|NCT00951171|E2|Reported Event|Standard IUI|Insemination with TOmcat catheter
279498|NCT00951171|E1|Reported Event|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
279499|NCT00951093|B1|Baseline|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery.
279500|NCT00951093|P1|Participant Flow|Patients Assessed for GERD|Patients assessed for GERD before and after Gastric Bypass Surgery
279501|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279502|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279503|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279504|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279505|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279506|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279507|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279508|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279509|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279510|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279511|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279512|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279513|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279514|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279515|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279516|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279517|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279518|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279519|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
279520|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
279521|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
279522|NCT00951093|E1|Reported Event|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery
279523|NCT00951015|B5|Baseline|Total|Total of all reporting groups
279524|NCT00951015|B4|Baseline|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279525|NCT00951015|B3|Baseline|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279526|NCT00951015|B2|Baseline|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279527|NCT00951015|B1|Baseline|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279528|NCT00951015|P4|Participant Flow|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279529|NCT00951015|P3|Participant Flow|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279530|NCT00951015|P2|Participant Flow|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279531|NCT00951015|P1|Participant Flow|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279532|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279533|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279534|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279535|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279536|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
279537|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
279538|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
279539|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279540|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279541|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279542|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279543|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
279544|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279545|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279546|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279547|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279548|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279549|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279550|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279551|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279552|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279553|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279554|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279555|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279556|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279557|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279558|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279559|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279560|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279561|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279562|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279563|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279564|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279565|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279566|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279567|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279568|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279569|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279570|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279571|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279572|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279573|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279574|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279575|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279576|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279577|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279578|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279579|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279580|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279581|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279582|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279583|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279584|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279585|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279586|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279587|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279588|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279589|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279590|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279591|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279592|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279593|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279594|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279595|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279596|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279597|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279598|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279599|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279600|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279601|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279602|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279603|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279604|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279605|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279606|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279607|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279608|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279609|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279610|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279611|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279612|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279613|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279614|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279615|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279616|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
280067|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
279617|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279618|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279619|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279620|NCT00951015|E4|Reported Event|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
279621|NCT00951015|E3|Reported Event|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279622|NCT00951015|E2|Reported Event|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279623|NCT00951015|E1|Reported Event|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
279624|NCT00950963|B3|Baseline|Total|Total of all reporting groups
279625|NCT00950963|B2|Baseline|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279626|NCT00950963|B1|Baseline|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279627|NCT00950963|P2|Participant Flow|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279628|NCT00950963|P1|Participant Flow|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279629|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279630|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279631|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279632|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279633|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279634|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279635|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279636|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279637|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
279638|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
279639|NCT00950963|E2|Reported Event|Standard Care|"Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.~Standard Clinical Care: Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses."
279640|NCT00950963|E1|Reported Event|Phone Counseling|"The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.~Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care."
279641|NCT00950937|B3|Baseline|Total|Total of all reporting groups
279642|NCT00950937|B2|Baseline|Control Group|Non HIV-infected persons
279643|NCT00950937|B1|Baseline|HIV Group|HIV infected persons
279644|NCT00950937|P2|Participant Flow|Control Group|Non HIV-infected persons
279645|NCT00950937|P1|Participant Flow|HIV Group|HIV infected persons
279646|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279647|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279648|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279649|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279650|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279651|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279652|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279653|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279654|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279655|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279656|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279657|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279658|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
279659|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
279660|NCT00950911|B3|Baseline|Total|Total of all reporting groups
279661|NCT00950911|B2|Baseline|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279662|NCT00950911|B1|Baseline|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279663|NCT00950911|P2|Participant Flow|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279664|NCT00950911|P1|Participant Flow|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279665|NCT00950911|O2|Outcome|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279666|NCT00950911|O1|Outcome|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279667|NCT00950911|E2|Reported Event|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279668|NCT00950911|E1|Reported Event|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
279669|NCT00950872|B1|Baseline|Duet TRS|"Subjects receive Duet TRS~Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS."
279670|NCT00950872|P1|Participant Flow|Duet TRS|Duet TRS is a staple line buttress
279671|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
279672|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
279673|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
279674|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
279675|NCT00950872|E1|Reported Event|Duet TRS|Duet TRS is a staple line buttress
279676|NCT00950859|B3|Baseline|Total|Total of all reporting groups
279677|NCT00950859|B2|Baseline|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279678|NCT00950859|B1|Baseline|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279679|NCT00950859|P2|Participant Flow|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279680|NCT00950859|P1|Participant Flow|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279681|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279682|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279683|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279684|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279685|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279686|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279687|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279688|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279689|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279690|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279691|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279820|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
279692|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279693|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279694|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279695|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279696|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279697|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279698|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279699|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279700|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279701|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279702|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279703|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279704|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279705|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279706|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279707|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279708|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279709|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279710|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279711|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279712|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279713|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279714|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279715|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279716|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279717|NCT00950859|E2|Reported Event|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
279718|NCT00950859|E1|Reported Event|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
279719|NCT00950807|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :~UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD."
279720|NCT00950807|P10|Participant Flow|Tiotropium 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
279721|NCT00950807|P9|Participant Flow|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279722|NCT00950807|P8|Participant Flow|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279723|NCT00950807|P7|Participant Flow|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279724|NCT00950807|P6|Participant Flow|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279725|NCT00950807|P5|Participant Flow|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279726|NCT00950807|P4|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279727|NCT00950807|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279728|NCT00950807|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279729|NCT00950807|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
279730|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
279731|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279732|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279733|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279734|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279735|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279736|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279737|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279738|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279821|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
279739|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
279740|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
279741|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279742|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279743|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279744|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279745|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279746|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279747|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279748|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279749|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
279750|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
279751|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279752|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279753|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279754|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279755|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279756|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279757|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279758|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279759|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
279760|NCT00950807|E10|Reported Event|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
279761|NCT00950807|E9|Reported Event|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279762|NCT00950807|E8|Reported Event|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279763|NCT00950807|E7|Reported Event|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
279764|NCT00950807|E6|Reported Event|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279765|NCT00950807|E5|Reported Event|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279766|NCT00950807|E4|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279767|NCT00950807|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279768|NCT00950807|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
279769|NCT00950807|E1|Reported Event|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
279770|NCT00950755|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279771|NCT00950755|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279809|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
279822|NCT00950690|E1|Reported Event|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
279823|NCT00950664|B3|Baseline|Total|Total of all reporting groups
279772|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279773|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279774|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279775|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279776|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279777|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279778|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279779|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279780|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279810|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.
279811|NCT00950742|E2|Reported Event|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
279781|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279782|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279783|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279784|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279785|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279786|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279787|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279788|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279789|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279812|NCT00950742|E1|Reported Event|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
279813|NCT00950729|B1|Baseline|Healthy Subjects|
279814|NCT00950729|P1|Participant Flow|Healthy Subjects|
279815|NCT00950729|O1|Outcome|Healthy Subjects|
279816|NCT00950729|O1|Outcome|Healthy Subjects|
279790|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279791|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279792|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279793|NCT00950755|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
279794|NCT00950742|B3|Baseline|Total|Total of all reporting groups
279795|NCT00950742|B2|Baseline|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279796|NCT00950742|B1|Baseline|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279797|NCT00950742|P2|Participant Flow|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279798|NCT00950742|P1|Participant Flow|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279799|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
279800|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
279801|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
279802|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279803|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279804|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279805|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279806|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279807|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
279808|NCT00950742|O1|Outcome|Afatinib|All patients received both Afatinib and Herceptin. Dose level 1 was continuous daily dosing with Afatinib 20mg tablets and once weekly an intravenous infusion of Herceptin. Dose level 2 was continuous daily dosing with Afatinib 30mg tablets and once weekly an intravenous infusion of Herceptin. Cycle length was 28 days.
279824|NCT00950664|B2|Baseline|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
279825|NCT00950664|B1|Baseline|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
279826|NCT00950664|P2|Participant Flow|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
279827|NCT00950664|P1|Participant Flow|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
279828|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279829|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279830|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279831|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279832|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279833|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279834|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279835|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279836|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279837|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279838|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279839|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279840|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279841|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279842|NCT00950664|E2|Reported Event|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
279843|NCT00950664|E1|Reported Event|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
279844|NCT00950651|B3|Baseline|Total|Total of all reporting groups
279845|NCT00950651|B2|Baseline|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279846|NCT00950651|B1|Baseline|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279847|NCT00950651|P2|Participant Flow|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279848|NCT00950651|P1|Participant Flow|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279849|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279850|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279851|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279852|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279853|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279854|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279855|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279856|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279857|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279858|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279859|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279860|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279861|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279862|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279863|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279864|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279865|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279866|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279867|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279868|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279869|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279870|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279871|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279872|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279873|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279874|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279875|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279876|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279877|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279878|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279879|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279880|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279881|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
280012|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279882|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279883|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279884|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279885|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279886|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279887|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279888|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279889|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279890|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279891|NCT00950651|E2|Reported Event|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279892|NCT00950651|E1|Reported Event|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
279893|NCT00950612|B3|Baseline|Total|Total of all reporting groups
279894|NCT00950612|B2|Baseline|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279895|NCT00950612|B1|Baseline|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279896|NCT00950612|P2|Participant Flow|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279897|NCT00950612|P1|Participant Flow|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279898|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279899|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279900|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279901|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279902|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279903|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279904|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279905|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279906|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279907|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279908|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279909|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279910|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279911|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279912|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279913|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279914|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279915|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279916|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279917|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279918|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279919|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279920|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279921|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279922|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279923|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279924|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279925|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279926|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279927|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279928|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279929|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279930|NCT00950612|E2|Reported Event|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
279931|NCT00950612|E1|Reported Event|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
279932|NCT00950599|B9|Baseline|Total|Total of all reporting groups
279933|NCT00950599|B8|Baseline|Placebo (0 & 100 mg Cohort)|
279934|NCT00950599|B7|Baseline|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279935|NCT00950599|B6|Baseline|Placebo (0-40 mg Cohort)|
279936|NCT00950599|B5|Baseline|Saxagliptin 40 mg (0-40 mg Cohort)|
279937|NCT00950599|B4|Baseline|Saxagliptin 20 mg (0-40 mg Cohort)|
279938|NCT00950599|B3|Baseline|Saxagliptin 10 mg (0-40 mg Cohort)|
279939|NCT00950599|B2|Baseline|Saxagliptin 5 mg (0-40 mg Cohort)|
279940|NCT00950599|B1|Baseline|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279941|NCT00950599|P10|Participant Flow|Saxa 0 & 100 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
280013|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280014|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280015|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280016|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280017|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280018|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279942|NCT00950599|P9|Participant Flow|Saxa 0-40 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
279943|NCT00950599|P8|Participant Flow|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
279944|NCT00950599|P7|Participant Flow|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
279945|NCT00950599|P6|Participant Flow|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
279946|NCT00950599|P5|Participant Flow|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
279947|NCT00950599|P4|Participant Flow|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
279948|NCT00950599|P3|Participant Flow|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
279949|NCT00950599|P2|Participant Flow|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
279950|NCT00950599|P1|Participant Flow|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
279951|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279952|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279953|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
279954|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
279955|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
279956|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
279957|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
279958|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279959|NCT00950599|O2|Outcome|Placebo (0 & 100 Cohort)|
279960|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279961|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
279962|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
279963|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
279964|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
279965|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
279966|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279967|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
279968|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279969|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
279970|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
279971|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
279972|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
279973|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
279974|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279975|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279976|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279977|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279978|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279979|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279980|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279981|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279982|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279983|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279984|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279985|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
279986|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279987|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
279988|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279989|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
279990|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
279991|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
279992|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
279993|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
279994|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
279995|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
279996|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
279997|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
279998|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
279999|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280000|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280001|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280002|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280003|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280004|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280005|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280006|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280007|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280008|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280009|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280010|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280011|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280068|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280069|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280070|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280071|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280072|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280073|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280074|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280075|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280076|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280077|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280078|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280079|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280080|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280081|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280082|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280083|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280084|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280085|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280086|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280087|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280088|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280089|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280090|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280091|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280092|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280093|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280094|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280095|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280096|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280097|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280098|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280099|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280100|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280101|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280102|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280103|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280104|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280105|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280106|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280107|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280108|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280109|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280110|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280111|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280112|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280113|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280114|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280115|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280116|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280117|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280118|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280119|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280120|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280121|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280122|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280123|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280124|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280125|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280126|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280127|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280128|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280129|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280130|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280131|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280132|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280133|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280134|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280135|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280136|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280137|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280138|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280139|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280140|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280141|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280142|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280143|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280144|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280145|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280146|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280147|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280148|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280149|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280150|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280151|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280152|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280153|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280154|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280155|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280156|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280157|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280158|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280159|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280160|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280161|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280162|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280163|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280164|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280165|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280166|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280167|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280168|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280169|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280170|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280171|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280172|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280173|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280174|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280175|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280176|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280177|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280178|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280179|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280180|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280181|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280182|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280183|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280184|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280185|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280186|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280187|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280188|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280189|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280190|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280191|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280192|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280193|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280194|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280195|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280196|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280197|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280198|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280199|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280200|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280201|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280202|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280203|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280204|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280205|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280206|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280207|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280208|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280209|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280210|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280211|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280212|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280213|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280214|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280215|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280216|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280217|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280218|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280219|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280220|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280221|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280222|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280223|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280224|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280225|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280226|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280227|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280228|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280229|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280230|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280231|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280232|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280233|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280234|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280235|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280236|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280237|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280238|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280239|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280240|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280241|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280242|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280243|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280244|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280245|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280246|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280247|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280248|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280249|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280250|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280251|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280252|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280253|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280254|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280255|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280256|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280257|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280258|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280259|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280260|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280261|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280262|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280263|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280264|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280265|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280266|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280267|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280268|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280269|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280270|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280271|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280272|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280273|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280274|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280275|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280276|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280277|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280278|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280279|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280280|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280281|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280282|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280283|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280284|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280285|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280286|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280287|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280288|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280289|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280290|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280291|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280292|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280293|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280294|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280295|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280296|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280297|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280298|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280299|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280300|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280301|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280302|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280303|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280304|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280305|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280306|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280307|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280308|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280309|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280310|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280311|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280312|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280313|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280314|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280315|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280316|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280317|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280318|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280319|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280320|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280321|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280322|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280323|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280324|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280325|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280326|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280327|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280328|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280329|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280330|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280331|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280332|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280333|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280334|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280335|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280336|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280337|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280338|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280339|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280340|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280341|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280342|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280343|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280344|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280345|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280346|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280347|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280348|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280349|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280350|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280351|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280352|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280353|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280354|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280355|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280356|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280357|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280358|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280359|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280360|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280361|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280362|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280363|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280364|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280365|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280366|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280367|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280368|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280369|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280370|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280371|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280372|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280373|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280374|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280375|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280376|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280377|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280378|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280379|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280380|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280381|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280382|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280383|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280384|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280385|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280386|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280387|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280388|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280389|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280390|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280391|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280392|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280393|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280394|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280395|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280396|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280397|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280398|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280399|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280400|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280401|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280402|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280403|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280404|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280405|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280406|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280407|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280408|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280409|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280410|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280411|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280412|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280413|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280414|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280415|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280416|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280417|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280418|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280419|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280420|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280421|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280422|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280423|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280424|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280425|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280426|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280427|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280428|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280429|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280430|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280431|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280432|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280433|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280434|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280435|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280436|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280437|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280438|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280439|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280440|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280441|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280442|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280443|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280444|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280445|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280446|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280447|NCT00950599|O8|Outcome|Placebo (0, 100 mg Cohort)|
280448|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0, 100 mg Cohort)|
280449|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280450|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280451|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280452|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280453|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280454|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280455|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280456|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280457|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280458|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280459|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280460|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280461|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280462|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280463|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280464|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280465|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280466|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280467|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280468|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280469|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280470|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280471|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280472|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280473|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280474|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280475|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280476|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280477|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280478|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280479|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280480|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280481|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280482|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280483|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
280484|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
280485|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280486|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280487|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280488|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280489|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280490|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280491|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280492|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280493|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280494|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280495|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280496|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280497|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
280498|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
280499|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
280500|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
280501|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
280502|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
280503|NCT00950599|E8|Reported Event|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
280504|NCT00950599|E7|Reported Event|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
280505|NCT00950599|E6|Reported Event|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
280506|NCT00950599|E5|Reported Event|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
280608|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280507|NCT00950599|E4|Reported Event|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
280508|NCT00950599|E3|Reported Event|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
280509|NCT00950599|E2|Reported Event|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
280510|NCT00950599|E1|Reported Event|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
280511|NCT00950352|B3|Baseline|Total|Total of all reporting groups
280512|NCT00950352|B2|Baseline|Placebo|"32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
280513|NCT00950352|B1|Baseline|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
280514|NCT00950352|P2|Participant Flow|Placebo|"32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks.~Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
280515|NCT00950352|P1|Participant Flow|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
280516|NCT00950352|O2|Outcome|Placebo|Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
280517|NCT00950352|O1|Outcome|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
280518|NCT00950352|E2|Reported Event|Placebo|
280519|NCT00950352|E1|Reported Event|Citicoline|
280520|NCT00950300|B3|Baseline|Total|Total of all reporting groups
280521|NCT00950300|B2|Baseline|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280522|NCT00950300|B1|Baseline|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280523|NCT00950300|P2|Participant Flow|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280524|NCT00950300|P1|Participant Flow|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m^2, epirubicin 75 mg/m^2, and cyclophosphamide 500 mg/m^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
280525|NCT00950300|O1|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280526|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280527|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280528|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280529|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280530|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280531|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280532|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280533|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280534|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280535|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280609|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280610|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280536|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280537|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280538|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280539|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280540|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280541|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280542|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280543|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280544|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280611|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280612|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280545|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280546|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280547|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280548|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280549|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280550|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280551|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280552|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280553|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280613|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280614|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280554|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280555|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280556|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280557|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280558|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280559|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280560|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280561|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280562|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280615|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280616|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280563|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280564|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280565|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280566|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280567|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
280568|NCT00950300|E8|Reported Event|Herceptin SC (SFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
280569|NCT00950300|E7|Reported Event|Herceptin IV (SFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
280570|NCT00950300|E6|Reported Event|Herceptin SC (TFFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
280571|NCT00950300|E5|Reported Event|Herceptin IV (TFFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
280572|NCT00950300|E4|Reported Event|Herceptin SC (Adjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The ten cycles of Herceptin SC after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
280573|NCT00950300|E3|Reported Event|Herceptin IV (Adjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The ten cycles of Herceptin IV after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
280574|NCT00950300|E2|Reported Event|Herceptin SC (Neoadjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
280575|NCT00950300|E1|Reported Event|Herceptin IV (Neoadjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
280576|NCT00950235|B3|Baseline|Total|Total of all reporting groups
280577|NCT00950235|B2|Baseline|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280578|NCT00950235|B1|Baseline|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280579|NCT00950235|P2|Participant Flow|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280580|NCT00950235|P1|Participant Flow|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280581|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280582|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280583|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280584|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280585|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280586|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280587|NCT00950235|E2|Reported Event|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
280588|NCT00950235|E1|Reported Event|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
280589|NCT00950183|B1|Baseline|Foot and Ankle Surgery|Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
280590|NCT00950183|P1|Participant Flow|Foot and Ankle Surgery|
280591|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
280592|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
280593|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
280594|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
280595|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
280596|NCT00950183|E1|Reported Event|Foot and Ankle Surgery|
280597|NCT00949975|B5|Baseline|Total|Total of all reporting groups
280598|NCT00949975|B4|Baseline|Placebo|Matched Placebo Tablets
280599|NCT00949975|B3|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280600|NCT00949975|B2|Baseline|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280601|NCT00949975|B1|Baseline|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280602|NCT00949975|P4|Participant Flow|Placebo|Matched Placebo Tablets
280603|NCT00949975|P3|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280604|NCT00949975|P2|Participant Flow|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280605|NCT00949975|P1|Participant Flow|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280606|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280607|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
281273|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
280617|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280618|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280619|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280620|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280621|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280622|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280623|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280624|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280625|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280626|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280627|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280628|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280629|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280630|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280631|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280632|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280633|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280634|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280635|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280636|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280637|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280638|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280639|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280640|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280641|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280642|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280643|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280644|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280645|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280646|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280647|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280648|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280649|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280650|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280651|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280652|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280653|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280654|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280655|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280656|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280657|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280658|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280659|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280660|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280661|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280662|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280663|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280664|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280665|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280666|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280667|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280668|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280669|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280670|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280671|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280672|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280673|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280674|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280675|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280676|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280677|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280678|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280679|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280680|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280681|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280682|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280683|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280684|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280685|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280686|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280687|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280688|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280689|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280690|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280691|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280692|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280693|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280694|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280695|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280696|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280697|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280698|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280699|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280700|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280701|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280702|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280703|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280704|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280705|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280706|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280707|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280708|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280709|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280710|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280711|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280712|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280713|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280714|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
280715|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280716|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280717|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280718|NCT00949975|E4|Reported Event|Placebo|Matched Placebo Tablets
280719|NCT00949975|E3|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
280720|NCT00949975|E2|Reported Event|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
280721|NCT00949975|E1|Reported Event|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
280722|NCT00949910|B1|Baseline|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280723|NCT00949910|P1|Participant Flow|Erlotinib|Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280724|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280725|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280726|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280760|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280761|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280727|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280728|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280729|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280730|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280731|NCT00949910|E1|Reported Event|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
280732|NCT00949884|B4|Baseline|Total|Total of all reporting groups
280733|NCT00949884|B3|Baseline|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280734|NCT00949884|B2|Baseline|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
280735|NCT00949884|B1|Baseline|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280736|NCT00949884|P3|Participant Flow|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280737|NCT00949884|P2|Participant Flow|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
280738|NCT00949884|P1|Participant Flow|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280739|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280740|NCT00949884|O2|Outcome|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
280741|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280742|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280743|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280744|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280745|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280746|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280747|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280748|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280749|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280750|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280751|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280752|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280753|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280754|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280755|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280756|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280757|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280758|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280759|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280762|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280763|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280764|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280765|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280766|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280767|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280768|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280769|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280770|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280771|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280772|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280773|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280774|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280775|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280776|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280777|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280778|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280779|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280780|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280781|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280782|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280783|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280784|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280785|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
280786|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280787|NCT00949884|E3|Reported Event|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
280788|NCT00949884|E2|Reported Event|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
280789|NCT00949884|E1|Reported Event|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
280790|NCT00949715|B3|Baseline|Total|Total of all reporting groups
280791|NCT00949715|B2|Baseline|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280792|NCT00949715|B1|Baseline|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280793|NCT00949715|P2|Participant Flow|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280794|NCT00949715|P1|Participant Flow|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280795|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280818|NCT00949702|E1|Reported Event|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280796|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280797|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280798|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280799|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280800|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280801|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280802|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
280803|NCT00949715|E1|Reported Event|No Subjects|No subjects had adverse events or death collected as part of this study.
280804|NCT00949702|B1|Baseline|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280805|NCT00949702|P1|Participant Flow|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280806|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280807|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280808|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280809|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280810|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280811|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280812|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280813|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280814|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280815|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280816|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280817|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
280819|NCT00949650|B3|Baseline|Total|Total of all reporting groups
281054|NCT00948441|B2|Baseline|Group 2|Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
280820|NCT00949650|B2|Baseline|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280821|NCT00949650|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280822|NCT00949650|P2|Participant Flow|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280823|NCT00949650|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280824|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
280825|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280826|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
280827|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
280828|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
280829|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280830|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
280831|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
280832|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
280833|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280834|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
280835|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
280836|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280837|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280838|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280839|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280840|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280841|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280842|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280843|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280844|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280845|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280846|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280847|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280848|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280849|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280850|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280851|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280852|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280853|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280854|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280855|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280856|NCT00949650|E2|Reported Event|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
280857|NCT00949650|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
280858|NCT00949533|B3|Baseline|Total|Total of all reporting groups
280859|NCT00949533|B2|Baseline|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280860|NCT00949533|B1|Baseline|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280861|NCT00949533|P2|Participant Flow|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280862|NCT00949533|P1|Participant Flow|Standard Dose|Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280863|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280864|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280865|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280866|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280867|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280868|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280869|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280870|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280871|NCT00949533|E2|Reported Event|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
280872|NCT00949533|E1|Reported Event|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
280873|NCT00949117|B3|Baseline|Total|Total of all reporting groups
280874|NCT00949117|B2|Baseline|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280875|NCT00949117|B1|Baseline|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280876|NCT00949117|P2|Participant Flow|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280877|NCT00949117|P1|Participant Flow|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280878|NCT00949117|O2|Outcome|Cyproheptadine HCl & PediaSure or Ensure|"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~Ensure: Given orally~PediaSure: Given orally~cyproheptadine hydrochloride: Given orally"
280879|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~cyproheptadine hydrochloride: Given orally"
280880|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280881|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280882|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280883|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280884|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280885|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280886|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280887|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280888|NCT00949117|E2|Reported Event|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280889|NCT00949117|E1|Reported Event|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
280890|NCT00948896|B9|Baseline|Total|Total of all reporting groups
280891|NCT00948896|B8|Baseline|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280892|NCT00948896|B7|Baseline|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280893|NCT00948896|B6|Baseline|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280894|NCT00948896|B5|Baseline|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280895|NCT00948896|B4|Baseline|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280896|NCT00948896|B3|Baseline|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280897|NCT00948896|B2|Baseline|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280898|NCT00948896|B1|Baseline|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
280899|NCT00948896|P8|Participant Flow|HIV-exposed & DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280900|NCT00948896|P7|Participant Flow|HIV-exposed & TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280901|NCT00948896|P6|Participant Flow|HIV-exposed & SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280902|NCT00948896|P5|Participant Flow|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280903|NCT00948896|P4|Participant Flow|HIV-unexposed & DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280904|NCT00948896|P3|Participant Flow|HIV-unexposed & TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280905|NCT00948896|P2|Participant Flow|HIV-unexposed & SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280906|NCT00948896|P1|Participant Flow|HIV-unexposed & No Chemoprevention|HIV-unexposed No chemoprevention was given
280907|NCT00948896|O4|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280908|NCT00948896|O3|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280909|NCT00948896|O2|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280910|NCT00948896|O1|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280911|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280912|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280913|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280914|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
280915|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280916|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280917|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280918|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280919|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280920|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280921|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280922|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
280923|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280924|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280925|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280926|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280927|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280928|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280929|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280930|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
280931|NCT00948896|E8|Reported Event|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280932|NCT00948896|E7|Reported Event|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
281052|NCT00947505|E1|Reported Event|LLT Device 2009 7 Beam|
280933|NCT00948896|E6|Reported Event|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280934|NCT00948896|E5|Reported Event|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
280935|NCT00948896|E4|Reported Event|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
280936|NCT00948896|E3|Reported Event|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
280937|NCT00948896|E2|Reported Event|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
280938|NCT00948896|E1|Reported Event|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
280939|NCT00948857|B3|Baseline|Total|Total of all reporting groups
280940|NCT00948857|B2|Baseline|Blinded Placebo|Blinded placebo
280941|NCT00948857|B1|Baseline|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
280942|NCT00948857|P2|Participant Flow|Blinded Placebo|Blinded placebo
280943|NCT00948857|P1|Participant Flow|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
280944|NCT00948857|O2|Outcome|Placebo|Blinded placebo
280945|NCT00948857|O1|Outcome|DHEA|Dehydroepiandrosterone 25 mg tid po
280946|NCT00948857|E2|Reported Event|Blinded Placebo|Blinded placebo
280947|NCT00948857|E1|Reported Event|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
280948|NCT00948818|B3|Baseline|Total|Total of all reporting groups
280949|NCT00948818|B2|Baseline|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280950|NCT00948818|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
280951|NCT00948818|P2|Participant Flow|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280952|NCT00948818|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
280953|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280954|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280955|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280956|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280957|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280958|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280959|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280960|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280961|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280962|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280963|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280964|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280965|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280966|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280967|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280968|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280969|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280970|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280971|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280972|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280973|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280974|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280975|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280976|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280977|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280978|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280979|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
280980|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
280981|NCT00948818|E5|Reported Event|Linaclotide to Linaclotide - Randomized Withdrawal Period|Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
280982|NCT00948818|E4|Reported Event|Linaclotide to Placebo - Randomized Withdrawal Period|"Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period."
280983|NCT00948818|E3|Reported Event|Placebo to Linaclotide - Randomized Withdrawal Period|"Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received dose-matched placebo during the 12-week randomized treatment period."
280984|NCT00948818|E2|Reported Event|Linaclotide - Treatment Period|Linaclotide 290µg, oral administration, once per day.
280985|NCT00948818|E1|Reported Event|Placebo - Treatment Period|Dose-matched placebo, oral administration, once per day.
280986|NCT00948792|B1|Baseline|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
280987|NCT00948792|P1|Participant Flow|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
281053|NCT00948441|B3|Baseline|Total|Total of all reporting groups
281274|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
280988|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
280989|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
280990|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
280991|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
280992|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
280993|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
280994|NCT00948792|E2|Reported Event|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
280995|NCT00948792|E1|Reported Event|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
280996|NCT00948766|B3|Baseline|Total|Total of all reporting groups
280997|NCT00948766|B2|Baseline|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
280998|NCT00948766|B1|Baseline|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
280999|NCT00948766|P2|Participant Flow|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281000|NCT00948766|P1|Participant Flow|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281001|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281002|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281003|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281004|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281005|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281006|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281007|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281008|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281009|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281010|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281011|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281012|NCT00948766|E3|Reported Event|Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281013|NCT00948766|E2|Reported Event|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
281014|NCT00948766|E1|Reported Event|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
281015|NCT00948675|B3|Baseline|Total|Total of all reporting groups
281016|NCT00948675|B2|Baseline|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281017|NCT00948675|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281018|NCT00948675|P2|Participant Flow|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281019|NCT00948675|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281020|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281021|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281022|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281023|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281024|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281025|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281026|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281027|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281028|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281029|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281030|NCT00948675|E2|Reported Event|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
281031|NCT00948675|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
281032|NCT00948506|B3|Baseline|Total|Total of all reporting groups
281033|NCT00948506|B2|Baseline|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281034|NCT00948506|B1|Baseline|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281035|NCT00948506|P2|Participant Flow|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281036|NCT00948506|P1|Participant Flow|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281037|NCT00948506|O2|Outcome|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
281038|NCT00948506|O1|Outcome|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
281039|NCT00948506|O3|Outcome|Placebo|Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
281040|NCT00948506|O2|Outcome|3% Cidofovir|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
281041|NCT00948506|O1|Outcome|1% Cidofovir|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
281042|NCT00948506|E2|Reported Event|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281043|NCT00948506|E1|Reported Event|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
281044|NCT00947505|B3|Baseline|Total|Total of all reporting groups
281045|NCT00947505|B2|Baseline|Control Device|
281046|NCT00947505|B1|Baseline|LLT Device 2009 7 Beam|
281047|NCT00947505|P2|Participant Flow|Control Device|
281048|NCT00947505|P1|Participant Flow|LLT Device 2009 7 Beam|
281049|NCT00947505|O2|Outcome|Control Device|This is the control device emitting white light
281050|NCT00947505|O1|Outcome|LLT Device 2009 7 Beam|This is the active LLLT device
281051|NCT00947505|E2|Reported Event|Control Device|
281055|NCT00948441|B1|Baseline|Group 1|25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
281056|NCT00948441|P2|Participant Flow|Heparin Lock/Washout/25% Ethanol|First Heparin lock, then washout period, then 25% ethanol lock
281057|NCT00948441|P1|Participant Flow|25% Ethanol/Washout/Heparin|First 25% ethanol, then Washout, then heparin
281058|NCT00948441|O2|Outcome|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
281059|NCT00948441|O1|Outcome|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
281060|NCT00948441|O2|Outcome|Infections While Using Heparin Lock|"Heparin lock x 12 weeks~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours."
281061|NCT00948441|O1|Outcome|Infections While Using Ethanol Lock|"25% ethanol x 12 weeks~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
281062|NCT00948441|E2|Reported Event|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
281063|NCT00948441|E1|Reported Event|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
281064|NCT00948389|B6|Baseline|Total|Total of all reporting groups
281065|NCT00948389|B5|Baseline|Dose Level 3B|Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²
281066|NCT00948389|B4|Baseline|Dose Level 3A|Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²
281067|NCT00948389|B3|Baseline|Dose Level 2|Dasatinib: 100 mg BID + CCNU: 90 mg/m²
281068|NCT00948389|B2|Baseline|Dose Level 1B|Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²
281069|NCT00948389|B1|Baseline|Dose Level 1A|Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²
281070|NCT00948389|P5|Participant Flow|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281071|NCT00948389|P4|Participant Flow|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281072|NCT00948389|P3|Participant Flow|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281073|NCT00948389|P2|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2.
281074|NCT00948389|P1|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281075|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281076|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281077|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281078|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281079|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2
281080|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281081|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281082|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281083|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281084|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281085|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281086|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281087|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281088|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281089|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281090|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281091|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281092|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281226|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
281093|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281094|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281095|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281096|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281097|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281098|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281099|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281100|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281101|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281102|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281103|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281104|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281105|NCT00948389|E5|Reported Event|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
281106|NCT00948389|E4|Reported Event|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
281107|NCT00948389|E3|Reported Event|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
281108|NCT00948389|E2|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
281109|NCT00948389|E1|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
281110|NCT00948246|B1|Baseline|Easyband|
281111|NCT00948246|P1|Participant Flow|Easyband|
281112|NCT00948246|O1|Outcome|Easyband|
281113|NCT00948246|O1|Outcome|Easyband|
281114|NCT00948246|O1|Outcome|Easyband|
281115|NCT00948246|O1|Outcome|Easyband|
281116|NCT00948246|E1|Reported Event|Easyband|
281117|NCT00948155|B3|Baseline|Total|Total of all reporting groups
281118|NCT00948155|B2|Baseline|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281119|NCT00948155|B1|Baseline|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281120|NCT00948155|P2|Participant Flow|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281121|NCT00948155|P1|Participant Flow|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281122|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281123|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281124|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281125|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281126|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281127|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281128|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281129|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281130|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281131|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281132|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
281133|NCT00948155|O1|Outcome|Placebo|21 days using placebo
281134|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281135|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281179|NCT00948064|E1|Reported Event|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
281180|NCT00947882|B5|Baseline|Total|Total of all reporting groups
281136|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281137|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281138|NCT00948155|E2|Reported Event|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281139|NCT00948155|E1|Reported Event|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
281140|NCT00948090|B3|Baseline|Total|Total of all reporting groups
281141|NCT00948090|B2|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281142|NCT00948090|B1|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281143|NCT00948090|P4|Participant Flow|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281144|NCT00948090|P3|Participant Flow|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281145|NCT00948090|P2|Participant Flow|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281146|NCT00948090|P1|Participant Flow|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281147|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281148|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281149|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281150|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281151|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281152|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281153|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281154|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281272|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
281155|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281156|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281157|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281158|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281159|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281160|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281161|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281162|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
281163|NCT00948090|E1|Reported Event|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)|The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
281164|NCT00948064|B4|Baseline|Total|Total of all reporting groups
281165|NCT00948064|B3|Baseline|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281166|NCT00948064|B2|Baseline|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281167|NCT00948064|B1|Baseline|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
281168|NCT00948064|P3|Participant Flow|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281169|NCT00948064|P2|Participant Flow|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281170|NCT00948064|P1|Participant Flow|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
281171|NCT00948064|O2|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281172|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281173|NCT00948064|O3|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281174|NCT00948064|O2|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281175|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
281176|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
281177|NCT00948064|E3|Reported Event|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281178|NCT00948064|E2|Reported Event|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
281181|NCT00947882|B4|Baseline|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281182|NCT00947882|B3|Baseline|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281183|NCT00947882|B2|Baseline|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281184|NCT00947882|B1|Baseline|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281185|NCT00947882|P4|Participant Flow|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281186|NCT00947882|P3|Participant Flow|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281187|NCT00947882|P2|Participant Flow|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281188|NCT00947882|P1|Participant Flow|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281189|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281190|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281191|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281192|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281193|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281194|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281195|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281196|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281197|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281198|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281199|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281200|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281201|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281202|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281203|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281204|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281205|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281206|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281207|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281208|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
281209|NCT00947882|E4|Reported Event|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281210|NCT00947882|E3|Reported Event|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281211|NCT00947882|E2|Reported Event|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281212|NCT00947882|E1|Reported Event|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
281213|NCT00947856|B3|Baseline|Total|Total of all reporting groups
281214|NCT00947856|B2|Baseline|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
281215|NCT00947856|B1|Baseline|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
281216|NCT00947856|P2|Participant Flow|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
281217|NCT00947856|P1|Participant Flow|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
281218|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
281219|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
281220|NCT00947856|O5|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
281221|NCT00947856|O4|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
281222|NCT00947856|O3|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
281223|NCT00947856|O2|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
281224|NCT00947856|O1|Outcome|BV Extension Total|All patients enrolled and treated on the extension arm
281225|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
281227|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
281228|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
281229|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
281230|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
281231|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
281232|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
281233|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
281234|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
281235|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
281236|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
281237|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
281238|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
281239|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
281240|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
281241|NCT00947856|E2|Reported Event|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
281242|NCT00947856|E1|Reported Event|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
281243|NCT00947765|B3|Baseline|Total|Total of all reporting groups
281244|NCT00947765|B2|Baseline|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281245|NCT00947765|B1|Baseline|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281246|NCT00947765|P2|Participant Flow|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281247|NCT00947765|P1|Participant Flow|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281248|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281249|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281250|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281251|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281252|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281253|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281254|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281255|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281256|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281257|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281258|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281259|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281260|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281261|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281262|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281263|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281264|NCT00947765|E2|Reported Event|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
281265|NCT00947765|E1|Reported Event|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
281266|NCT00947752|B3|Baseline|Total|Total of all reporting groups
281267|NCT00947752|B2|Baseline|F2 Glatiramer Acetate 20mg/0.5ml|
281268|NCT00947752|B1|Baseline|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
281269|NCT00947752|P2|Participant Flow|F2 Glatiramer Acetate 20mg/0.5ml|
281270|NCT00947752|P1|Participant Flow|F1 Glatiramer Acetate 20mg/1.0ml|
281271|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
281275|NCT00947752|E2|Reported Event|F2 Glatiramer Acetate 20mg/0.5ml|
281276|NCT00947752|E1|Reported Event|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
281277|NCT00947661|B3|Baseline|Total|Total of all reporting groups
281278|NCT00947661|B2|Baseline|Reference0912|Reference0912 administered once daily for 12 weeks
281279|NCT00947661|B1|Baseline|SPARC0912|SPARC0912 administered once daily for 12 weeks
281280|NCT00947661|P2|Participant Flow|Reference0912|Reference0912 administered once daily for 12 weeks
281281|NCT00947661|P1|Participant Flow|SPARC0912|SPARC0912 administered once daily for 12 weeks
281282|NCT00947661|O2|Outcome|Reference0912|
281283|NCT00947661|O1|Outcome|SPARC0912|The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
281284|NCT00947661|E2|Reported Event|Reference0912|Reference formulation administered once daily for 12 weeks
281285|NCT00947661|E1|Reported Event|SPARC0912|SPARC's formulation administered once daily for 12 weeks
281286|NCT00947544|B1|Baseline|Participants in SO and SE|Patients who completed switch over study and enrolled safety extension study
281287|NCT00947544|P2|Participant Flow|Safety Extension Only|Participants entered the safety extension part of the study only, and received open-label HPN-100 for up to 12 months.
281288|NCT00947544|P1|Participant Flow|Swich Over and Safety Extension|NaPBA was dosed three times daily (TID) with during the first week and the same PBA mole-equivalent dose of HPN-100 during the second week. If there were safety concerns regarding a single-step transition from NaPBA to HPN-100, at the investigator's discretion, the transition could occur in 2 steps such that in the second week, subjects might receive 50% of the PBA equivalent dose as NaPBA and 50% as HPN-100 before receiving 100% of Serial blood samples were collected for PK and blood ammonia assessments after each drug reached steady state, which was achieved approximately 4 days after initiation of 100% NaPBA or HPN100 treatment. After the switch over, participants entered the safety extension part of the study and continued receiving open-label HPN-100 for up to 12 months.
281289|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100 who completed SF-15 at baseline and Month 12
281290|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281291|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281292|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281293|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281294|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281295|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281296|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281297|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281298|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281299|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281300|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281301|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281302|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281303|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281304|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
281305|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
281306|NCT00947544|O2|Outcome|Safety Extension (HPN-100)|
281307|NCT00947544|O1|Outcome|Pre-Enrollment (NaPBA)|
281308|NCT00947544|O2|Outcome|NaPBA|NaPBA: Patients treated with NaPBA
281309|NCT00947544|O1|Outcome|HPN-100|HPN-100: Patients treated with HPN-100
281310|NCT00947544|E1|Reported Event|HPN-100|HPN-100: Patient treated with HPN-100
281311|NCT00947531|B3|Baseline|Total|Total of all reporting groups
281312|NCT00947531|B2|Baseline|0.9% Saline Solution|
281313|NCT00947531|B1|Baseline|Cerebrolysin|
281314|NCT00947531|P2|Participant Flow|0.9% Saline Solution|
281315|NCT00947531|P1|Participant Flow|Cerebrolysin|
281316|NCT00947531|O2|Outcome|0.9% Saline Solution|
281317|NCT00947531|O1|Outcome|Cerebrolysin|
281318|NCT00947531|E2|Reported Event|0.9% Saline Solution|
281319|NCT00947531|E1|Reported Event|Cerebrolysin|
281320|NCT00947518|B4|Baseline|Total|Total of all reporting groups
281321|NCT00947518|B3|Baseline|No Skin Cleansing|No skin application
281322|NCT00947518|B2|Baseline|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
281323|NCT00947518|B1|Baseline|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
281324|NCT00947518|P3|Participant Flow|No Skin Cleansing|No skin application
281325|NCT00947518|P2|Participant Flow|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
281326|NCT00947518|P1|Participant Flow|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
281327|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
281328|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
281329|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
281330|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
281331|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
281332|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
281333|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
282068|NCT00945100|B1|Baseline|Control|2 hours daily patching
281334|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
281335|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
281336|NCT00947427|B3|Baseline|Total|Total of all reporting groups
281337|NCT00947427|B2|Baseline|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
281338|NCT00947427|B1|Baseline|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
281339|NCT00947427|P2|Participant Flow|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
281340|NCT00947427|P1|Participant Flow|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
281341|NCT00947427|O2|Outcome|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
281342|NCT00947427|O1|Outcome|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
281343|NCT00947427|E2|Reported Event|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
281344|NCT00947427|E1|Reported Event|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
281345|NCT00947349|B5|Baseline|Total|Total of all reporting groups
281346|NCT00947349|B4|Baseline|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281347|NCT00947349|B3|Baseline|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
281348|NCT00947349|B2|Baseline|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281349|NCT00947349|B1|Baseline|Placebo in TN Patients|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281350|NCT00947349|P4|Participant Flow|BI 201335 NA High for Treatment Experienced (TE)|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
281351|NCT00947349|P3|Participant Flow|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281352|NCT00947349|P2|Participant Flow|BI 201335 NA Low for Treatment Naive (TN)|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
281353|NCT00947349|P1|Participant Flow|Placebo in Treatment Naive (TN) Patients|Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
281354|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281355|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281356|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281357|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281358|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281359|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281360|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281361|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281362|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281363|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281364|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281365|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281366|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281367|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281368|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281369|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281370|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281371|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281372|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281373|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281374|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281375|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281376|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281377|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
284535|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
281378|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281379|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281380|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281381|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281382|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281383|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281384|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281385|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281386|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281387|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281388|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281389|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281390|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281391|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281392|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281393|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281394|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281395|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281396|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281397|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281398|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281399|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
281400|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281401|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281402|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281403|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281404|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281405|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281406|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281407|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
281408|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281409|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281410|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281411|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281412|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281413|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281414|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281415|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281416|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281417|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281418|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281419|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281420|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281421|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281422|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281423|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281424|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281425|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281426|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281427|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281428|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281429|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281430|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281431|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281432|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281433|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281434|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281435|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281436|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281437|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281438|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281439|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281440|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281441|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281442|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281443|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281444|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281445|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281446|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281447|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281448|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281449|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281450|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281451|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281452|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281453|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281454|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281455|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281456|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281457|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281458|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281459|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281460|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281461|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281462|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281463|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
282140|NCT00945035|E2|Reported Event|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
281464|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
281465|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
281466|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
281467|NCT00947349|O1|Outcome|Placebo in TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
281468|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281469|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281470|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281471|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281472|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281473|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
281474|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
281475|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
281476|NCT00947349|E8|Reported Event|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
281477|NCT00947349|E7|Reported Event|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
281478|NCT00947349|E6|Reported Event|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
281479|NCT00947349|E5|Reported Event|SOC TN Placebo|Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
281480|NCT00947349|E4|Reported Event|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
281481|NCT00947349|E3|Reported Event|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
281482|NCT00947349|E2|Reported Event|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
281483|NCT00947349|E1|Reported Event|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
281484|NCT00947310|B4|Baseline|Total|Total of all reporting groups
281485|NCT00947310|B3|Baseline|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281486|NCT00947310|B2|Baseline|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281487|NCT00947310|B1|Baseline|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281488|NCT00947310|P3|Participant Flow|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281489|NCT00947310|P2|Participant Flow|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281490|NCT00947310|P1|Participant Flow|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281491|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281492|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281493|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281494|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281495|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281496|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281497|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281498|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281499|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281500|NCT00947310|E3|Reported Event|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
281501|NCT00947310|E2|Reported Event|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
281502|NCT00947310|E1|Reported Event|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
281503|NCT00947297|B1|Baseline|HPN-100|Patients who were treated with HPN-100
281504|NCT00947297|P1|Participant Flow|HPN-100|Patients who were treated with HPN-100
281505|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
281703|NCT00946309|E2|Reported Event|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
284536|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
281506|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
281507|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
281508|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
281509|NCT00947297|E1|Reported Event|HPN-100|Patients who were treated with HPN-100
281510|NCT00947284|B1|Baseline|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
281511|NCT00947284|P2|Participant Flow|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
281512|NCT00947284|P1|Participant Flow|Women-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
281513|NCT00947284|O1|Outcome|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
281514|NCT00947284|E1|Reported Event|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
281515|NCT00947271|B5|Baseline|Total|Total of all reporting groups
281516|NCT00947271|B4|Baseline|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281517|NCT00947271|B3|Baseline|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281518|NCT00947271|B2|Baseline|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281519|NCT00947271|B1|Baseline|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281520|NCT00947271|P4|Participant Flow|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281521|NCT00947271|P3|Participant Flow|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281522|NCT00947271|P2|Participant Flow|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281523|NCT00947271|P1|Participant Flow|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281524|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281525|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281704|NCT00946309|E1|Reported Event|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281526|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281527|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281528|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281529|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281530|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281531|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281532|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281533|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281534|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281535|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281536|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281537|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281538|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281539|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281540|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281541|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281542|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281543|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281544|NCT00947271|E4|Reported Event|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281545|NCT00947271|E3|Reported Event|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
281705|NCT00946296|B3|Baseline|Total|Total of all reporting groups
281706|NCT00946296|B2|Baseline|No Treatment|The experimental group receives no treatment.
281546|NCT00947271|E2|Reported Event|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281547|NCT00947271|E1|Reported Event|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
281548|NCT00947219|B4|Baseline|Total|Total of all reporting groups
281549|NCT00947219|B3|Baseline|Control Device|Control device emitting LED light
281550|NCT00947219|B2|Baseline|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
281551|NCT00947219|B1|Baseline|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
281552|NCT00947219|P3|Participant Flow|Control Device|Control device emitting LED light
281553|NCT00947219|P2|Participant Flow|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
281554|NCT00947219|P1|Participant Flow|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
281555|NCT00947219|O3|Outcome|Control Device|Control device emitting white light
281556|NCT00947219|O2|Outcome|HairMax LaserComb 2009 9 Beam|the active LLLT Device 2009 9 laser modules
281557|NCT00947219|O1|Outcome|HairMax LaserComb 2009, 12 Beam|The active LLLT Device 2009 with 12 laser modules
281558|NCT00947219|E3|Reported Event|Control Device|Control device emitting LED light
281559|NCT00947219|E2|Reported Event|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
281560|NCT00947219|E1|Reported Event|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
281561|NCT00947154|B1|Baseline|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
281562|NCT00947154|P1|Participant Flow|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
281563|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
281564|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
281565|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
281566|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
281567|NCT00947154|E1|Reported Event|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
281568|NCT00947115|B4|Baseline|Total|Total of all reporting groups
281569|NCT00947115|B3|Baseline|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281570|NCT00947115|B2|Baseline|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281571|NCT00947115|B1|Baseline|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281572|NCT00947115|P3|Participant Flow|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
282141|NCT00945035|E1|Reported Event|Etoricoxib FMI|FMI Formulation (20%), Final Market Image
281573|NCT00947115|P2|Participant Flow|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281574|NCT00947115|P1|Participant Flow|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281575|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281576|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281577|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281578|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281579|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281580|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281581|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281582|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281583|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281584|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281585|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281586|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281587|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281588|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281589|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281590|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281591|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281592|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281593|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281594|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281595|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281596|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281597|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281984|NCT00945334|B2|Baseline|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
281598|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281599|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281600|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281601|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281602|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281603|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281604|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281605|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281606|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281607|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281608|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281609|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281610|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281611|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281612|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281613|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281614|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281615|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281616|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281617|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281618|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281619|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281620|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281621|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281622|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281985|NCT00945334|B1|Baseline|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
281623|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281624|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281625|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281626|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281627|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281628|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281629|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281630|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281631|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281632|NCT00947115|E3|Reported Event|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281633|NCT00947115|E2|Reported Event|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281634|NCT00947115|E1|Reported Event|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
281635|NCT00946985|B1|Baseline|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
281636|NCT00946985|P1|Participant Flow|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
281637|NCT00946985|O1|Outcome|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
281638|NCT00946985|E1|Reported Event|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
281639|NCT00946920|B3|Baseline|Total|Total of all reporting groups
281640|NCT00946920|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281641|NCT00946920|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281642|NCT00946920|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281643|NCT00946920|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281644|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281645|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281646|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281647|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281648|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
282142|NCT00944710|B3|Baseline|Total|Total of all reporting groups
281649|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281650|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281651|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281652|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281653|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281654|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281655|NCT00946920|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
281656|NCT00946920|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
281657|NCT00946478|B3|Baseline|Total|Total of all reporting groups
281658|NCT00946478|B2|Baseline|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281659|NCT00946478|B1|Baseline|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281660|NCT00946478|P2|Participant Flow|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281661|NCT00946478|P1|Participant Flow|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281662|NCT00946478|O2|Outcome|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281663|NCT00946478|O1|Outcome|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281707|NCT00946296|B1|Baseline|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
281708|NCT00946296|P2|Participant Flow|No Treatment|The experimental group receives no treatment.
282493|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
281664|NCT00946478|E2|Reported Event|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281665|NCT00946478|E1|Reported Event|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
281666|NCT00946348|B3|Baseline|Total|Total of all reporting groups
281667|NCT00946348|B2|Baseline|Cannabis|Cannabis cigarette (3.6% THC)
281668|NCT00946348|B1|Baseline|Dronabinol|Dronabinol 15 mg
281669|NCT00946348|P2|Participant Flow|Cannabis|Cannabis cigarette (3.6% THC)
281670|NCT00946348|P1|Participant Flow|Dronabinol|Dronabinol 15 mg
281671|NCT00946348|O2|Outcome|Cannabis|Cannabis cigarette (3.6% THC)
281672|NCT00946348|O1|Outcome|Dronabinol|Dronabinol 15 mg
281673|NCT00946348|E2|Reported Event|Cannabis|Cannabis cigarette (3.6% THC)
281674|NCT00946348|E1|Reported Event|Dronabinol|Dronabinol 15 mg
281675|NCT00946322|B1|Baseline|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281676|NCT00946322|P1|Participant Flow|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281677|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281678|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281679|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281680|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281681|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281682|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281683|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281684|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281685|NCT00946322|E1|Reported Event|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
281686|NCT00946309|B3|Baseline|Total|Total of all reporting groups
281687|NCT00946309|B2|Baseline|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
281688|NCT00946309|B1|Baseline|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281689|NCT00946309|P2|Participant Flow|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
281690|NCT00946309|P1|Participant Flow|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281691|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
281692|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281693|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
281694|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281695|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
281696|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281697|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
281698|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281699|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
281700|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
281701|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
281702|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
284537|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
281709|NCT00946296|P1|Participant Flow|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
281710|NCT00946296|O2|Outcome|No Treatment|The experimental group receives no treatment.
281711|NCT00946296|O1|Outcome|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
281712|NCT00946296|E2|Reported Event|No Treatment|The experimental group receives no treatment.
281713|NCT00946296|E1|Reported Event|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
281714|NCT00946114|B3|Baseline|Total|Total of all reporting groups
281715|NCT00946114|B2|Baseline|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
281716|NCT00946114|B1|Baseline|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
281717|NCT00946114|P2|Participant Flow|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
281718|NCT00946114|P1|Participant Flow|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
281719|NCT00946114|O2|Outcome|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
281720|NCT00946114|O1|Outcome|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
281721|NCT00946114|E2|Reported Event|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
281722|NCT00946114|E1|Reported Event|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
281723|NCT00946101|B3|Baseline|Total|Total of all reporting groups
281724|NCT00946101|B2|Baseline|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281725|NCT00946101|B1|Baseline|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281726|NCT00946101|P2|Participant Flow|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281727|NCT00946101|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281728|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281729|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281730|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281731|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281732|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281733|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281734|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281735|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281736|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281737|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281738|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281739|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281740|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281741|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281742|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281743|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281744|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281745|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281746|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281747|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281748|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281749|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281750|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281751|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281752|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281753|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281754|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281755|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281756|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281757|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281758|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281986|NCT00945334|P2|Participant Flow|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
281759|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281760|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281761|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281762|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281763|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281764|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281765|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281766|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281767|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281768|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281769|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281770|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281771|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281772|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281773|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281774|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281775|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281776|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281777|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281778|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281779|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281780|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281781|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281782|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281783|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281784|NCT00946101|E6|Reported Event|Placebo Days 58-209|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
281785|NCT00946101|E5|Reported Event|H1N1 Monovalent Vaccine Days 58-209|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
281786|NCT00946101|E4|Reported Event|Placebo Days 29-57|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
281787|NCT00946101|E3|Reported Event|H1N1 Monvalent Vaccine Days 29-57|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
281788|NCT00946101|E2|Reported Event|Placebo Days 1-28|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
281789|NCT00946101|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-28|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
281790|NCT00946088|B3|Baseline|Total|Total of all reporting groups
281791|NCT00946088|B2|Baseline|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
281792|NCT00946088|B1|Baseline|Progesterone|Progesterone 400 mg per vagina qhs.
281793|NCT00946088|P2|Participant Flow|Placebo|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
281794|NCT00946088|P1|Participant Flow|Progesterone|Progesterone 400 mg per vagina qhs.
281795|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281796|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281797|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281798|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281799|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281800|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281801|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281802|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281803|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281804|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281805|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281806|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281807|NCT00946088|O2|Outcome|Polyethylene & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281808|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281809|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281810|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281811|NCT00946088|O2|Outcome|Polyethylene Glycol&Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
281812|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
281813|NCT00946088|E2|Reported Event|Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab|Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
281814|NCT00946088|E1|Reported Event|Active Comparator: Progesterone|Progesterone 400mg per vagina qhs.
281815|NCT00945958|B1|Baseline|SPARC0913|Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
281816|NCT00945958|P1|Participant Flow|SPARC0913|
281817|NCT00945958|O1|Outcome|SPARC0913|SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks
281818|NCT00945958|O1|Outcome|SPARC|The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
281819|NCT00945958|E1|Reported Event|SPARC0913|From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
281820|NCT00945945|B3|Baseline|Total|Total of all reporting groups
281871|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
282069|NCT00945100|P2|Participant Flow|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
281821|NCT00945945|B2|Baseline|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281822|NCT00945945|B1|Baseline|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281823|NCT00945945|P2|Participant Flow|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281824|NCT00945945|P1|Participant Flow|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281825|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281826|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281827|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281828|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281829|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281872|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281987|NCT00945334|P1|Participant Flow|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
281830|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281831|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281832|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281833|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281834|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281835|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281836|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281837|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281838|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281944|NCT00945750|B6|Baseline|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
281839|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281840|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281841|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281842|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281843|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281844|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281845|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281846|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281847|NCT00945945|E2|Reported Event|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
281873|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281848|NCT00945945|E1|Reported Event|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
281849|NCT00945906|B1|Baseline|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281850|NCT00945906|P1|Participant Flow|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281851|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281852|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281853|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281854|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281855|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281856|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281857|NCT00945906|E1|Reported Event|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
281858|NCT00945893|B3|Baseline|Total|Total of all reporting groups
281859|NCT00945893|B2|Baseline|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281860|NCT00945893|B1|Baseline|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281861|NCT00945893|P2|Participant Flow|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281862|NCT00945893|P1|Participant Flow|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
281863|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281864|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281865|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281866|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281867|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281868|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281869|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281870|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281874|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281875|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281876|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281877|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281878|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281879|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281880|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281881|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281882|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281883|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281884|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281885|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281886|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281887|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281888|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281889|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281890|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281891|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281892|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281893|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281894|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281979|NCT00945477|P1|Participant Flow|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
281980|NCT00945477|O1|Outcome|Participants With Adverse Events 800mg Pazopanib|Adverse events for all participants, all grades
281895|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281896|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281897|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281898|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281899|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281900|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281901|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281902|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281903|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281904|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281905|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281906|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281907|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281908|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281909|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281910|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281911|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281912|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281913|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281914|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281981|NCT00945477|O1|Outcome|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
281982|NCT00945477|E1|Reported Event|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
281983|NCT00945334|B3|Baseline|Total|Total of all reporting groups
281915|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281916|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281917|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
281918|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281919|NCT00945893|E6|Reported Event|Placebo Days 58-209|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281920|NCT00945893|E5|Reported Event|H1N1 Monovalent Days 58-209|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281921|NCT00945893|E4|Reported Event|Placebo Days 29-57|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281922|NCT00945893|E3|Reported Event|H1N1 Monovalent Vaccine Days 29-57|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281923|NCT00945893|E2|Reported Event|Placebo Days 1-15|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281924|NCT00945893|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-15|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
281925|NCT00945854|B3|Baseline|Total|Total of all reporting groups
281926|NCT00945854|B2|Baseline|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281927|NCT00945854|B1|Baseline|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281928|NCT00945854|P2|Participant Flow|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281929|NCT00945854|P1|Participant Flow|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281930|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
282066|NCT00945100|B3|Baseline|Total|Total of all reporting groups
282070|NCT00945100|P1|Participant Flow|Control|2 hours daily patching
281931|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281932|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281933|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281934|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281935|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281936|NCT00945854|E2|Reported Event|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281937|NCT00945854|E1|Reported Event|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
281938|NCT00945815|B1|Baseline|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
281939|NCT00945815|P1|Participant Flow|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
281940|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
281941|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
281942|NCT00945815|E1|Reported Event|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
281943|NCT00945750|B7|Baseline|Total|Total of all reporting groups
281945|NCT00945750|B5|Baseline|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
281946|NCT00945750|B4|Baseline|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
281947|NCT00945750|B3|Baseline|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
281948|NCT00945750|B2|Baseline|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
281949|NCT00945750|B1|Baseline|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
281950|NCT00945750|P6|Participant Flow|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
281951|NCT00945750|P5|Participant Flow|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
281952|NCT00945750|P4|Participant Flow|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
281953|NCT00945750|P3|Participant Flow|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
281954|NCT00945750|P2|Participant Flow|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
281955|NCT00945750|P1|Participant Flow|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
281956|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
281957|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
281958|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
281959|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
281960|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
281961|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
281962|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
281963|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
281964|NCT00945750|E3|Reported Event|Famotidine 20 mg CT With Water|Famotidine 20 mg chewable tablet with 120 mL of water
281965|NCT00945750|E2|Reported Event|Famotidine 20 mg CT Without Water|Famotidine 20 mg Chewable Tablet without water
281966|NCT00945750|E1|Reported Event|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
281967|NCT00945555|B1|Baseline|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281968|NCT00945555|P1|Participant Flow|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281969|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281970|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281971|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281972|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281973|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281974|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281975|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281976|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281977|NCT00945555|E1|Reported Event|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
281978|NCT00945477|B1|Baseline|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
282067|NCT00945100|B2|Baseline|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
281988|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
281989|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
281990|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
281991|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
281992|NCT00945334|E2|Reported Event|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
281993|NCT00945334|E1|Reported Event|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
281994|NCT00945321|B1|Baseline|All Participants|All randomized patients.
281995|NCT00945321|P6|Participant Flow|C/B/A/E|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
281996|NCT00945321|P5|Participant Flow|B/A/C/E|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
281997|NCT00945321|P4|Participant Flow|A/C/B/E|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
281998|NCT00945321|P3|Participant Flow|C/A/B/D|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
281999|NCT00945321|P2|Participant Flow|B/C/A/D|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
282000|NCT00945321|P1|Participant Flow|A/B/C/D|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
282001|NCT00945321|O6|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
282002|NCT00945321|O5|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
282003|NCT00945321|O4|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
282004|NCT00945321|O3|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
282005|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
282006|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
282007|NCT00945321|O7|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
282008|NCT00945321|O6|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
282009|NCT00945321|O5|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
282010|NCT00945321|O4|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
282011|NCT00945321|O3|Outcome|150 mg Fosaprepitant Dimeglumine (Fasted State)|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
282012|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
282013|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
282014|NCT00945321|E5|Reported Event|185 mg Aprepitant (Fed State)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
282015|NCT00945321|E4|Reported Event|165 mg Aprepitant (Fed State)|"165 mg aprepitant Final Market Composition capsule in the fed~state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the~subjects (9) in this treatment group received a standard light breakfast)"
282016|NCT00945321|E3|Reported Event|150 mg Fosaprepitant Dimeglumine|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
282017|NCT00945321|E2|Reported Event|185 mg Aprepitant|185 mg aprepitant Final Market Composition capsule in the fasted state
282018|NCT00945321|E1|Reported Event|165 mg Aprepitant|165 mg aprepitant Final Market Composition capsule in the fasted state
282019|NCT00945295|B3|Baseline|Total|Total of all reporting groups
282020|NCT00945295|B2|Baseline|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282021|NCT00945295|B1|Baseline|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282022|NCT00945295|P2|Participant Flow|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282023|NCT00945295|P1|Participant Flow|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282024|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282025|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282026|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282027|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282028|NCT00945295|E2|Reported Event|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282029|NCT00945295|E1|Reported Event|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
282030|NCT00945256|B6|Baseline|Total|Total of all reporting groups
282031|NCT00945256|B5|Baseline|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
282032|NCT00945256|B4|Baseline|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282033|NCT00945256|B3|Baseline|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282034|NCT00945256|B2|Baseline|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282035|NCT00945256|B1|Baseline|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282036|NCT00945256|P5|Participant Flow|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
282037|NCT00945256|P4|Participant Flow|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282038|NCT00945256|P3|Participant Flow|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282039|NCT00945256|P2|Participant Flow|Elderly Aerobic Exercise|45 minutes of treadmill walking at 40% VO2 peak.
282040|NCT00945256|P1|Participant Flow|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak
282041|NCT00945256|O5|Outcome|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
282042|NCT00945256|O4|Outcome|Elderly Sodium Nitroprusside (SNP)|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282043|NCT00945256|O3|Outcome|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282044|NCT00945256|O2|Outcome|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282045|NCT00945256|O1|Outcome|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282046|NCT00945256|E5|Reported Event|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
282047|NCT00945256|E4|Reported Event|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282048|NCT00945256|E3|Reported Event|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
282049|NCT00945256|E2|Reported Event|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282050|NCT00945256|E1|Reported Event|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
282051|NCT00945243|B1|Baseline|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282052|NCT00945243|P1|Participant Flow|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282053|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282054|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282055|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282056|NCT00945243|E1|Reported Event|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
282057|NCT00945139|B1|Baseline|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
282058|NCT00945139|P1|Participant Flow|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
282059|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
282060|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
282061|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
282062|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
282063|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
282064|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
282065|NCT00945139|E1|Reported Event|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
282071|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282072|NCT00945100|O1|Outcome|Control|2 hours daily patching
282073|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282074|NCT00945100|O1|Outcome|Control|2 hours daily patching
282075|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282076|NCT00945100|O1|Outcome|Control|2 hours daily patching
282077|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282078|NCT00945100|O1|Outcome|Control|2 hours daily patching
282079|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282080|NCT00945100|O1|Outcome|Control|2 hours daily patching
282081|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282082|NCT00945100|O1|Outcome|Control|2 hours daily patching
282083|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282084|NCT00945100|O1|Outcome|Control|2 hours daily patching
282085|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282086|NCT00945100|O1|Outcome|Control|2 hours daily patching
282087|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282088|NCT00945100|O1|Outcome|Control|2 hours daily patching
282089|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282090|NCT00945100|O1|Outcome|Control|2 hours daily patching
282091|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282092|NCT00945100|O1|Outcome|Control|2 hours daily patching
282093|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282094|NCT00945100|O1|Outcome|Control|2 hours daily patching
282095|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282096|NCT00945100|O1|Outcome|Control|2 hours daily patching
282097|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282098|NCT00945100|O1|Outcome|Control|2 hours daily patching
282099|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282100|NCT00945100|O1|Outcome|Control|2 hours daily patching
282101|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282102|NCT00945100|O1|Outcome|Control|2 hours daily patching
282103|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282104|NCT00945100|O1|Outcome|Control|2 hours daily patching
282105|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282106|NCT00945100|O1|Outcome|Control|2 hours daily patching
282107|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282108|NCT00945100|O1|Outcome|Control|2 hours daily patching
282109|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282110|NCT00945100|O1|Outcome|Control|2 hours daily patching
282111|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282112|NCT00945100|O1|Outcome|Control|2 hours daily patching
282113|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282114|NCT00945100|O1|Outcome|Control|2 hours daily patching
282115|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282116|NCT00945100|O1|Outcome|Control|2 hours daily patching
282117|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282118|NCT00945100|O1|Outcome|Control|2 hours daily patching
282119|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282120|NCT00945100|O1|Outcome|Control|2 hours daily patching
282121|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282122|NCT00945100|O1|Outcome|Control|2 hours daily patching
282123|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282124|NCT00945100|O1|Outcome|Control|2 hours daily patching
282125|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282126|NCT00945100|O1|Outcome|Control|2 hours daily patching
282127|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282128|NCT00945100|O1|Outcome|Control|2 hours daily patching
282129|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282130|NCT00945100|O1|Outcome|Control|2 hours daily patching
282131|NCT00945100|E2|Reported Event|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
282132|NCT00945100|E1|Reported Event|Control|2 hours daily patching
282133|NCT00945035|B1|Baseline|All Participants in Study|
282134|NCT00945035|P2|Participant Flow|Etoricoxib URC Then Etoricoxib FMI|URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
282135|NCT00945035|P1|Participant Flow|Etoricoxib FMI Then Etoricoxib URC|FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
282136|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
282137|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
282138|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
282139|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
282143|NCT00944710|B2|Baseline|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282144|NCT00944710|B1|Baseline|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282145|NCT00944710|P2|Participant Flow|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282146|NCT00944710|P1|Participant Flow|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282147|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282148|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282149|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282150|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282151|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282152|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282153|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282154|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282155|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282156|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282157|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282158|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282159|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282160|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282161|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282162|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282163|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282164|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282165|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282166|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282167|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282168|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282169|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282170|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282171|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282172|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282173|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282174|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282175|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282176|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282177|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282178|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282179|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282180|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282181|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282182|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282183|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282184|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282185|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282186|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282187|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282188|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282189|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282190|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282191|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282192|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282551|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
282193|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282194|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282195|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282196|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282197|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282198|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282199|NCT00944710|E2|Reported Event|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
282200|NCT00944710|E1|Reported Event|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
282201|NCT00944697|B3|Baseline|Total|Total of all reporting groups
282202|NCT00944697|B2|Baseline|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
282203|NCT00944697|B1|Baseline|Placebo Tablets|A placebo tablet to match the active reference treatment
282204|NCT00944697|P2|Participant Flow|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
282205|NCT00944697|P1|Participant Flow|Placebo Tablets|A placebo tablet to match the active reference treatment
282206|NCT00944697|O2|Outcome|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
282207|NCT00944697|O1|Outcome|Placebo Tablets|A placebo tablet to match the active reference treatment
282208|NCT00944697|E2|Reported Event|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
282209|NCT00944697|E1|Reported Event|Placebo Tablets|A placebo tablet to match the active reference treatment
282210|NCT00944671|B7|Baseline|Total|Total of all reporting groups
282211|NCT00944671|B6|Baseline|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
282212|NCT00944671|B5|Baseline|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
282213|NCT00944671|B4|Baseline|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
282214|NCT00944671|B3|Baseline|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
282215|NCT00944671|B2|Baseline|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
282216|NCT00944671|B1|Baseline|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
282217|NCT00944671|P6|Participant Flow|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
282218|NCT00944671|P5|Participant Flow|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
282219|NCT00944671|P4|Participant Flow|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
282220|NCT00944671|P3|Participant Flow|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
282221|NCT00944671|P2|Participant Flow|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
282222|NCT00944671|P1|Participant Flow|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
282223|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
282224|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
282225|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
282226|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
282227|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
282228|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
282229|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
282230|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
282231|NCT00944671|E3|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water
282232|NCT00944671|E2|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet Without Water|Famotidine/antacid combination EZ Chew tablet without water
282233|NCT00944671|E1|Reported Event|Famotidine/Antacid Combination Tablet With Water|Famotidine/antacid combination tablet with 120 mL of water
282234|NCT00944645|B1|Baseline|All Participants|Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet
282548|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
282235|NCT00944645|P2|Participant Flow|MK0524A New Site Tablet Then MK0524A Phase III Tablet|MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)
282236|NCT00944645|P1|Participant Flow|MK0524A Phase III Tablet Then MK0524A New Site Tablet|MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)
282237|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
282238|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
282239|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
282240|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
282241|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
282242|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
282243|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
282244|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
282245|NCT00944645|E2|Reported Event|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
282246|NCT00944645|E1|Reported Event|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
282247|NCT00944450|B1|Baseline|All Participants|
282248|NCT00944450|P2|Participant Flow|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
282249|NCT00944450|P1|Participant Flow|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
282250|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
282251|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
282252|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
282253|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
282254|NCT00944450|E2|Reported Event|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
282255|NCT00944450|E1|Reported Event|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
282256|NCT00944229|B1|Baseline|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282257|NCT00944229|P1|Participant Flow|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282258|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282259|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282260|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282261|NCT00944229|E1|Reported Event|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
282262|NCT00944125|B1|Baseline|All Study Participants|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
282263|NCT00944125|P2|Participant Flow|BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
282264|NCT00944125|P1|Participant Flow|Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
282265|NCT00944125|O2|Outcome|BiV Pacing|
282266|NCT00944125|O1|Outcome|Dual Site LV Pacing|
282267|NCT00944125|E2|Reported Event|BiV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
282268|NCT00944125|E1|Reported Event|Dual Site LV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
282269|NCT00944073|B3|Baseline|Total|Total of all reporting groups
282270|NCT00944073|B2|Baseline|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282271|NCT00944073|B1|Baseline|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282272|NCT00944073|P2|Participant Flow|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282273|NCT00944073|P1|Participant Flow|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282274|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282275|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282276|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282277|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282278|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282279|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282280|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282281|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282282|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282283|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282284|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282285|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282286|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282287|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282288|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282289|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282290|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282291|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282292|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282293|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282294|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282295|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282296|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282297|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282298|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282299|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282300|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282301|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282302|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282303|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282304|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282305|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282306|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282307|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282308|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282309|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282310|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282311|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282312|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282313|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282314|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282315|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282316|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282317|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282318|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282319|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282320|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282321|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282322|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282323|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282324|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282325|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282326|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282327|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282328|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282329|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282330|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282331|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282332|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282333|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282334|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282335|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282336|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282337|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282338|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282339|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282340|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282341|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282342|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282343|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282344|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282345|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282346|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282347|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282348|NCT00944073|E2|Reported Event|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282349|NCT00944073|E1|Reported Event|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
282350|NCT00944034|B13|Baseline|Total|Total of all reporting groups
282351|NCT00944034|B12|Baseline|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282352|NCT00944034|B11|Baseline|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282353|NCT00944034|B10|Baseline|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282354|NCT00944034|B9|Baseline|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282355|NCT00944034|B8|Baseline|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282356|NCT00944034|B7|Baseline|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282357|NCT00944034|B6|Baseline|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282358|NCT00944034|B5|Baseline|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282359|NCT00944034|B4|Baseline|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282360|NCT00944034|B3|Baseline|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282361|NCT00944034|B2|Baseline|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282362|NCT00944034|B1|Baseline|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282363|NCT00944034|P12|Participant Flow|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282364|NCT00944034|P11|Participant Flow|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282365|NCT00944034|P10|Participant Flow|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282366|NCT00944034|P9|Participant Flow|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282367|NCT00944034|P8|Participant Flow|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282368|NCT00944034|P7|Participant Flow|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282369|NCT00944034|P6|Participant Flow|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282370|NCT00944034|P5|Participant Flow|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282371|NCT00944034|P4|Participant Flow|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282372|NCT00944034|P3|Participant Flow|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282373|NCT00944034|P2|Participant Flow|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282374|NCT00944034|P1|Participant Flow|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
282375|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282376|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282377|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282378|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282379|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282380|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282381|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282382|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282383|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282384|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282385|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282386|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282387|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282388|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282389|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282390|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282391|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282392|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282393|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282394|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282395|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282396|NCT00944034|O8|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282397|NCT00944034|O7|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282549|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
282398|NCT00944034|O6|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282399|NCT00944034|O5|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282400|NCT00944034|O4|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282401|NCT00944034|O3|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282402|NCT00944034|O2|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282403|NCT00944034|O1|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282404|NCT00944034|O4|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282405|NCT00944034|O3|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282406|NCT00944034|O2|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282407|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282408|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282409|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282410|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282411|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282412|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282413|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282414|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282415|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282416|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282417|NCT00944034|O3|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282418|NCT00944034|O2|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282419|NCT00944034|O1|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282420|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282421|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282422|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282423|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282424|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282425|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282426|NCT00944034|E12|Reported Event|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
282427|NCT00944034|E11|Reported Event|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
282428|NCT00944034|E10|Reported Event|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
282429|NCT00944034|E9|Reported Event|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282430|NCT00944034|E8|Reported Event|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282431|NCT00944034|E7|Reported Event|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
282550|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
282432|NCT00944034|E6|Reported Event|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
282433|NCT00944034|E5|Reported Event|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
282434|NCT00944034|E4|Reported Event|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282435|NCT00944034|E3|Reported Event|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
282436|NCT00944034|E2|Reported Event|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
282437|NCT00944034|E1|Reported Event|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
282438|NCT00944021|B6|Baseline|Total|Total of all reporting groups
282439|NCT00944021|B5|Baseline|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282440|NCT00944021|B4|Baseline|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282441|NCT00944021|B3|Baseline|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282442|NCT00944021|B2|Baseline|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282443|NCT00944021|B1|Baseline|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282444|NCT00944021|P5|Participant Flow|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282445|NCT00944021|P4|Participant Flow|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282446|NCT00944021|P3|Participant Flow|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282447|NCT00944021|P2|Participant Flow|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282448|NCT00944021|P1|Participant Flow|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282449|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282450|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282451|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282452|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282453|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282454|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282455|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282456|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282457|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282458|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282459|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282460|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282461|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282462|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282463|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282464|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282465|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282466|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282467|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282468|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282469|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282470|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282471|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282472|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282473|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282474|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282475|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282476|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282477|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282478|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282479|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282480|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282481|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282482|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282483|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282484|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282485|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282486|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282487|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282488|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282489|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282490|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282491|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282492|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282494|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282495|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282496|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282497|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282498|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282499|NCT00944021|E5|Reported Event|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
282500|NCT00944021|E4|Reported Event|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
282501|NCT00944021|E3|Reported Event|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
282502|NCT00944021|E2|Reported Event|PA-824 100mg/qd|PA-824 : 100mg oral tablet
282503|NCT00944021|E1|Reported Event|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
282504|NCT00943917|B16|Baseline|Total|Total of all reporting groups
282505|NCT00943917|B15|Baseline|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
282506|NCT00943917|B14|Baseline|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282507|NCT00943917|B13|Baseline|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
282508|NCT00943917|B12|Baseline|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282509|NCT00943917|B11|Baseline|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282510|NCT00943917|B10|Baseline|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
282511|NCT00943917|B9|Baseline|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
282512|NCT00943917|B8|Baseline|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
282513|NCT00943917|B7|Baseline|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
282514|NCT00943917|B6|Baseline|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
282515|NCT00943917|B5|Baseline|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
282516|NCT00943917|B4|Baseline|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
282517|NCT00943917|B3|Baseline|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
282518|NCT00943917|B2|Baseline|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
282519|NCT00943917|B1|Baseline|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
282520|NCT00943917|P15|Participant Flow|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
282521|NCT00943917|P14|Participant Flow|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282522|NCT00943917|P13|Participant Flow|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
282523|NCT00943917|P12|Participant Flow|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282524|NCT00943917|P11|Participant Flow|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
282525|NCT00943917|P10|Participant Flow|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
282526|NCT00943917|P9|Participant Flow|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
282527|NCT00943917|P8|Participant Flow|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
282528|NCT00943917|P7|Participant Flow|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
282529|NCT00943917|P6|Participant Flow|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
282530|NCT00943917|P5|Participant Flow|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
282531|NCT00943917|P4|Participant Flow|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
282532|NCT00943917|P3|Participant Flow|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
282533|NCT00943917|P2|Participant Flow|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
282534|NCT00943917|P1|Participant Flow|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
282535|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
282536|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
282537|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
282538|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
282539|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
282540|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
282541|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
282542|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
282543|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
282544|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
282545|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
282546|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II Continuation
282547|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
282552|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
282553|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
282554|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
282555|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
282556|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
282557|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
282558|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II & Stage II Continuation
282559|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
282560|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
282561|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
282562|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
282563|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
282564|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
282565|NCT00943917|E15|Reported Event|Ex Inj/ITCA 650 60 Continutation|Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
282566|NCT00943917|E14|Reported Event|Ex Inj/ITCA 40 Continuation|Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
282567|NCT00943917|E13|Reported Event|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
282568|NCT00943917|E12|Reported Event|ITCA 650 40/40 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
282569|NCT00943917|E11|Reported Event|ITCA 650 20/60 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
282570|NCT00943917|E10|Reported Event|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
282571|NCT00943917|E9|Reported Event|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
282572|NCT00943917|E8|Reported Event|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
282573|NCT00943917|E7|Reported Event|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
282574|NCT00943917|E6|Reported Event|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
282575|NCT00943917|E5|Reported Event|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
282576|NCT00943917|E4|Reported Event|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
282577|NCT00943917|E3|Reported Event|Exenatide Injection|exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
282578|NCT00943917|E2|Reported Event|ITCA 650 40 mcg/Day|ITCA 650 40 mcg/day continuous exenatide
282579|NCT00943917|E1|Reported Event|ITCA 650 20 mcg/Day|ITCA 650 20 mcg/day continuous exenatide
282580|NCT00943878|B5|Baseline|Total|Total of all reporting groups
282581|NCT00943878|B4|Baseline|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282582|NCT00943878|B3|Baseline|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282583|NCT00943878|B2|Baseline|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282584|NCT00943878|B1|Baseline|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282585|NCT00943878|P4|Participant Flow|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282586|NCT00943878|P3|Participant Flow|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282587|NCT00943878|P2|Participant Flow|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282588|NCT00943878|P1|Participant Flow|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282589|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282590|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282591|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282592|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282593|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282594|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282595|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282596|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282597|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282598|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282599|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282600|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282601|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282602|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282603|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282604|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282605|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282606|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282607|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282608|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282609|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282610|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282611|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282612|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282613|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282614|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282615|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282616|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282617|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282618|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282619|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282620|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282621|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282622|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282623|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282624|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282625|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282751|NCT00943761|B3|Baseline|Total|Total of all reporting groups
282626|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282627|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282628|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282629|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282630|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282631|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282632|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282633|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282634|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282635|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282636|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282637|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282638|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282639|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282640|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282641|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282642|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282643|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282644|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282645|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282646|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282647|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282648|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282649|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282650|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282651|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282652|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282653|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282654|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282655|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
284538|NCT00939094|E2|Reported Event|2 - Placebo|Placebo, capsule
282656|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282657|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282658|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282659|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282660|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282661|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282662|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282663|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282664|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282665|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282666|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282667|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282668|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282669|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282670|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282671|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282672|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282673|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282674|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282675|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282676|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282677|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282678|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282679|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282680|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282681|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282682|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282683|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282684|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282685|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
284539|NCT00939094|E1|Reported Event|A - AZD2066|AZD2066, 12 mg capsule
282686|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282687|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282688|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282689|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282690|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282691|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282692|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282693|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282694|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282695|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282696|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282697|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282698|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282699|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282700|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282701|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282702|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282703|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282704|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282705|NCT00943878|E4|Reported Event|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282706|NCT00943878|E3|Reported Event|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
282707|NCT00943878|E2|Reported Event|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
282708|NCT00943878|E1|Reported Event|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
282709|NCT00943852|B1|Baseline|All Participants in Study|
282710|NCT00943852|P10|Participant Flow|Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN|Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
282711|NCT00943852|P9|Participant Flow|Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan|Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
282712|NCT00943852|P8|Participant Flow|ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo|ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo – single dose with ≥ 4 days washout between doses
282713|NCT00943852|P7|Participant Flow|Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
282714|NCT00943852|P6|Participant Flow|Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN|Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
282715|NCT00943852|P5|Participant Flow|Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan|Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
283764|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
282716|NCT00943852|P4|Participant Flow|Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo|Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo – single dose with ≥ 4 days washout between doses
282717|NCT00943852|P3|Participant Flow|ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN|ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
282718|NCT00943852|P2|Participant Flow|Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
282719|NCT00943852|P1|Participant Flow|Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN|Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
282720|NCT00943852|O2|Outcome|Placebo|
282721|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
282722|NCT00943852|O2|Outcome|Losartan 100 mg|
282723|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
282724|NCT00943852|E5|Reported Event|ISMN 60 mg|
282725|NCT00943852|E4|Reported Event|Losartan 100 mg + ISMN 60 mg|
282726|NCT00943852|E3|Reported Event|Losartan 100 mg + ISMN 15 mg|
282727|NCT00943852|E2|Reported Event|Losartan 100 mg|
282728|NCT00943852|E1|Reported Event|Placebo|
282729|NCT00943826|B3|Baseline|Total|Total of all reporting groups
282730|NCT00943826|B2|Baseline|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282731|NCT00943826|B1|Baseline|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282732|NCT00943826|P2|Participant Flow|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression//unacceptable toxicity.
282733|NCT00943826|P1|Participant Flow|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282734|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282735|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282736|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282737|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282752|NCT00943761|B2|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
283765|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
282738|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282739|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282740|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282741|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282742|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282743|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282744|NCT00943826|E2|Reported Event|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
282745|NCT00943826|E1|Reported Event|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
282746|NCT00943787|B1|Baseline|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
282747|NCT00943787|P1|Participant Flow|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
282748|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
282749|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
282750|NCT00943787|E1|Reported Event|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
282753|NCT00943761|B1|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282754|NCT00943761|P2|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
282755|NCT00943761|P1|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
282756|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
282757|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282758|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
282759|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282760|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
282761|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282762|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
282763|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282764|NCT00943761|E2|Reported Event|Vaniprevir 600 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282765|NCT00943761|E1|Reported Event|Vaniprevir 300 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
282766|NCT00943735|B1|Baseline|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282767|NCT00943735|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282768|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282769|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282770|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282771|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282772|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282773|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282774|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282775|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282776|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282777|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282778|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282779|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282780|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282781|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282782|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282783|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282784|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282785|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282786|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282787|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282788|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282789|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282790|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282791|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282792|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282793|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282794|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282795|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282796|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282797|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282798|NCT00943735|E1|Reported Event|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
282799|NCT00943722|B6|Baseline|Total|Total of all reporting groups
282800|NCT00943722|B5|Baseline|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282898|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282801|NCT00943722|B4|Baseline|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282802|NCT00943722|B3|Baseline|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
282803|NCT00943722|B2|Baseline|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
282804|NCT00943722|B1|Baseline|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282805|NCT00943722|P5|Participant Flow|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282806|NCT00943722|P4|Participant Flow|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282807|NCT00943722|P3|Participant Flow|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
282808|NCT00943722|P2|Participant Flow|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
282809|NCT00943722|P1|Participant Flow|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282810|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
282811|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
282812|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282813|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282814|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282815|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282816|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282817|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282818|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282819|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2, or 3)|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
282820|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282821|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282822|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
282823|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282824|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282825|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
282826|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
282827|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
282828|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282829|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282830|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282831|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
283766|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
282832|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282833|NCT00943722|E3|Reported Event|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282834|NCT00943722|E2|Reported Event|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
282835|NCT00943722|E1|Reported Event|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
282836|NCT00943683|B3|Baseline|Total|Total of all reporting groups
282837|NCT00943683|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
282838|NCT00943683|B1|Baseline|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
282839|NCT00943683|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
282840|NCT00943683|P1|Participant Flow|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
282841|NCT00943683|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
282842|NCT00943683|O1|Outcome|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
282843|NCT00943683|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
282844|NCT00943683|E1|Reported Event|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
282845|NCT00943670|B1|Baseline|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282846|NCT00943670|P1|Participant Flow|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282847|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282848|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282849|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282850|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282851|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282852|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282853|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282854|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
282855|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282856|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
282857|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282858|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282859|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282860|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282861|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
282862|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282863|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282864|NCT00943670|O3|Outcome|Baseline-adjusted QTc Interval > 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282865|NCT00943670|O2|Outcome|Baseline-adjusted QTc Interval > 30 to ≤ 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 30 and less than or equal to 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282866|NCT00943670|O1|Outcome|Baseline-adjusted QTc Interval ≤ 30 ms|Participants with an average Baseline-adjusted QTc interval less than or equal to 30 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282867|NCT00943670|O4|Outcome|Average QTc Interval > 500 ms|Participants with an average QTc interval greater than 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282868|NCT00943670|O3|Outcome|Average QTc Interval > 480 to ≤ 500 ms|Participants with an average QTc interval greater than 480 and less than or equal to 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282869|NCT00943670|O2|Outcome|Average QTc Interval > 450 to ≤ 480 ms|Participants with an average QTc interval greater than 450 and less than or equal to 480 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282870|NCT00943670|O1|Outcome|Average QTc Interval ≤ 450 ms|Participants with an average QTc interval less than or equal to 450 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282871|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282872|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282873|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282874|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282875|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282876|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282877|NCT00943670|E2|Reported Event|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
282878|NCT00943670|E1|Reported Event|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
282879|NCT00943631|B3|Baseline|Total|Total of all reporting groups
282880|NCT00943631|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282881|NCT00943631|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282882|NCT00943631|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282883|NCT00943631|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282884|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282885|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282886|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282887|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282888|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282889|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282890|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282891|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282892|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282893|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282894|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282895|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282896|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282897|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282899|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282900|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282901|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282902|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282903|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282904|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282905|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282906|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282907|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282908|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282909|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282910|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282911|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282912|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282913|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282914|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282915|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282916|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282917|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282918|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282919|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282920|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282921|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282922|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282923|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282924|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282925|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282926|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282927|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282928|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282929|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282930|NCT00943631|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282931|NCT00943631|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282932|NCT00943605|B3|Baseline|Total|Total of all reporting groups
282933|NCT00943605|B2|Baseline|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282934|NCT00943605|B1|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
282935|NCT00943605|P2|Participant Flow|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282936|NCT00943605|P1|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
282937|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282938|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
282939|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282940|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
282941|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282942|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
282943|NCT00943605|E2|Reported Event|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
282944|NCT00943605|E1|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
283767|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
282945|NCT00943592|B1|Baseline|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282946|NCT00943592|P1|Participant Flow|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282947|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282948|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282949|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282950|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282951|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282952|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282953|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282954|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282955|NCT00943592|E1|Reported Event|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
282956|NCT00943579|B3|Baseline|Total|Total of all reporting groups
282957|NCT00943579|B2|Baseline|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282958|NCT00943579|B1|Baseline|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282959|NCT00943579|P2|Participant Flow|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282960|NCT00943579|P1|Participant Flow|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282961|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282962|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282963|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282964|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282965|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|
282966|NCT00943579|O1|Outcome|Kuvan Following Placebo|
283011|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
284540|NCT00939055|B3|Baseline|Total|Total of all reporting groups
282967|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282968|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282969|NCT00943579|E2|Reported Event|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
282970|NCT00943579|E1|Reported Event|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
282971|NCT00943488|B3|Baseline|Total|Total of all reporting groups
282972|NCT00943488|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282973|NCT00943488|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282974|NCT00943488|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282975|NCT00943488|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282976|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282977|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282978|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282979|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282980|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282981|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282982|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282983|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282984|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282985|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282986|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282987|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282988|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282989|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282990|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282991|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282992|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282993|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282994|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282995|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282996|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282997|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282998|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
282999|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283000|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283001|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283002|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283003|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283004|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283005|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283006|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283007|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283008|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283009|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283010|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283297|NCT00943150|B1|Baseline|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283012|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283013|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283014|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283015|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283016|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283017|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283018|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283019|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283020|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283021|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283022|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283023|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283024|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283025|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283026|NCT00943488|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283027|NCT00943488|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
283028|NCT00943436|B3|Baseline|Total|Total of all reporting groups
283029|NCT00943436|B2|Baseline|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283030|NCT00943436|B1|Baseline|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283031|NCT00943436|P2|Participant Flow|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283032|NCT00943436|P1|Participant Flow|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283033|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283034|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283035|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283036|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283037|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283038|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283039|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283040|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283041|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283042|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283043|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283044|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283045|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283046|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283047|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283048|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283049|NCT00943436|E2|Reported Event|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
283050|NCT00943436|E1|Reported Event|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
283051|NCT00943397|B3|Baseline|Total|Total of all reporting groups
283052|NCT00943397|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
283053|NCT00943397|B1|Baseline|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
283054|NCT00943397|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
283055|NCT00943397|P1|Participant Flow|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
283056|NCT00943397|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
283057|NCT00943397|O1|Outcome|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
283058|NCT00943397|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
283059|NCT00943397|E1|Reported Event|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
283298|NCT00943150|P2|Participant Flow|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283060|NCT00943384|B1|Baseline|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283061|NCT00943384|P1|Participant Flow|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283062|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283063|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283064|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283065|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283066|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283067|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283068|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283069|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283070|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283071|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283072|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283073|NCT00943384|E1|Reported Event|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
283074|NCT00943202|B5|Baseline|Total|Total of all reporting groups
283075|NCT00943202|B4|Baseline|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283076|NCT00943202|B3|Baseline|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283077|NCT00943202|B2|Baseline|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283078|NCT00943202|B1|Baseline|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283079|NCT00943202|P4|Participant Flow|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283080|NCT00943202|P3|Participant Flow|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283081|NCT00943202|P2|Participant Flow|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283082|NCT00943202|P1|Participant Flow|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283083|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283084|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283085|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283086|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283087|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283088|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283089|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283090|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283091|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283092|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283093|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283094|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283095|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283096|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283097|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283098|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283099|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283100|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283101|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283102|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283103|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283104|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283105|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283106|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283107|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283108|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283109|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283110|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283111|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283112|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283113|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283114|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283115|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283116|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283117|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283118|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283119|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283120|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283299|NCT00943150|P1|Participant Flow|PEAK PlasmaBlade|The PEAK PlasmaBlade for the abdominoplasty procedure.
283121|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283122|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283123|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283124|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283125|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283126|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283127|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283128|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283129|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283130|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283131|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283132|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283133|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283134|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283135|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283136|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283137|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283138|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283139|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283140|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283141|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283142|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283143|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283144|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283145|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283146|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283147|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283148|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283149|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283150|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283151|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283152|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283153|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283154|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283155|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283300|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283156|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283157|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283158|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283159|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283160|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283161|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283162|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283163|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283164|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283165|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283166|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283167|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283168|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283169|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283170|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283171|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283172|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283173|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283174|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283175|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283176|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283177|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283178|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283179|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283180|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283181|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283182|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283183|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283184|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283185|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283186|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283187|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283188|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283189|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283190|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283301|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283191|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283192|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283193|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283194|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283195|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283196|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283197|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283198|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283199|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283200|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283201|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283202|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283203|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283204|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283205|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283206|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283207|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283208|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283209|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283210|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283211|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283212|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283213|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283214|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283215|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283216|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283217|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283218|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283219|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283220|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283221|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283222|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283223|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283224|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283225|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283768|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283226|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283227|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283228|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283229|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283230|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283231|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283232|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283233|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283234|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283235|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283236|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283237|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283238|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283239|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283240|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283241|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283242|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283243|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283244|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283245|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283246|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283247|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283248|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283249|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283250|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283251|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283252|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283253|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283254|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283255|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283256|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283257|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283258|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283259|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283260|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283769|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283261|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283262|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283263|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283264|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283265|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283266|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283267|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283268|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283269|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283270|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283271|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283272|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283273|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283274|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283275|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283276|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283277|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283278|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283279|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283280|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283281|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283282|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283283|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283284|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283285|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283286|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283287|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283288|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283289|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283290|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283291|NCT00943202|E4|Reported Event|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
283292|NCT00943202|E3|Reported Event|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
283293|NCT00943202|E2|Reported Event|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
283294|NCT00943202|E1|Reported Event|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
283295|NCT00943150|B3|Baseline|Total|Total of all reporting groups
283296|NCT00943150|B2|Baseline|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283770|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283302|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283303|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283304|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283305|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283306|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283307|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283308|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283309|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283310|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283311|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283312|NCT00943150|O3|Outcome|Scalpel|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
283313|NCT00943150|O2|Outcome|Electrosurgery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
283314|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
283315|NCT00943150|O2|Outcome|Electrocautery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
283316|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
283317|NCT00943150|E2|Reported Event|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
283318|NCT00943150|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
283319|NCT00943124|B1|Baseline|Overall Study Population|All randomized patients
283320|NCT00943124|P2|Participant Flow|Simvastatin + MK0524A Then MK0524B|"Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.~Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet)."
283321|NCT00943124|P1|Participant Flow|MK0524B Then Simvastatin + MK0524A|"Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).~Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets."
283322|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283323|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283324|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283325|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283326|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283327|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283328|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283329|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283330|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283331|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283332|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283333|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283334|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283335|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283336|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283337|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283338|NCT00943124|E2|Reported Event|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
283339|NCT00943124|E1|Reported Event|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
283340|NCT00943111|B3|Baseline|Total|Total of all reporting groups
283341|NCT00943111|B2|Baseline|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283342|NCT00943111|B1|Baseline|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283343|NCT00943111|P3|Participant Flow|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
283344|NCT00943111|P2|Participant Flow|Imiglucerase: PAP|Imiglucerase (Cerezyme®) intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant’s past enzyme replacement therapy (ERT) dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283345|NCT00943111|P1|Participant Flow|Eliglustat: PAP|Eliglustat tartrate (Genz-112638) capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. The dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than [<] 5 nanogram per milliliter [ng/mL] the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was greater than or equal to [>=] 5 ng/mL the same dose was continued. The pharmacokinetic (PK) assessment at Week 2 and Week 6 were used for dose adjustment after Week 4 and Week 8, respectively.
283346|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283347|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283348|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283349|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283350|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283351|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283352|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283353|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283354|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283355|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283356|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283357|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283358|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283359|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283360|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283361|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283362|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283363|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283364|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283365|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283366|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283367|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283368|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283369|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283370|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
283371|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
283372|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
283373|NCT00943111|E2|Reported Event|Imiglucerase|PAP: Imiglucerase (Cerezyme®) intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change. LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations.
283374|NCT00943111|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. LTTP: Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
283375|NCT00943098|B3|Baseline|Total|Total of all reporting groups
283376|NCT00943098|B2|Baseline|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283377|NCT00943098|B1|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283378|NCT00943098|P2|Participant Flow|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283379|NCT00943098|P1|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283380|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283381|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283382|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283383|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283384|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283385|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283386|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
285876|NCT00934635|P9|Participant Flow|Control|PET Scan Control
283387|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283388|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283389|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283390|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283391|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283392|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283393|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283394|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283395|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283396|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283397|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283398|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283399|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283400|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283401|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283402|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283403|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283404|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283405|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283406|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283407|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283408|NCT00943098|E2|Reported Event|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
283409|NCT00943098|E1|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
283410|NCT00943072|B3|Baseline|Total|Total of all reporting groups
283411|NCT00943072|B2|Baseline|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283412|NCT00943072|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283413|NCT00943072|P2|Participant Flow|Sham Treatment|"Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
283414|NCT00943072|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
283415|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283416|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283417|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283418|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283419|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283420|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283421|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283422|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283423|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
283424|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
283480|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
283425|NCT00943072|E4|Reported Event|Sham Treatment to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
283426|NCT00943072|E3|Reported Event|IAI to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
283427|NCT00943072|E2|Reported Event|Sham Treatment (Baseline to Week 24)|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
283428|NCT00943072|E1|Reported Event|Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.~Participants in the safety population were at risk."
283429|NCT00942994|B3|Baseline|Total|Total of all reporting groups
283430|NCT00942994|B2|Baseline|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283431|NCT00942994|B1|Baseline|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283432|NCT00942994|P2|Participant Flow|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283433|NCT00942994|P1|Participant Flow|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283434|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283435|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283436|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283437|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283438|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283439|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283440|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283441|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283442|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283443|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283444|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283481|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
289951|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
283445|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283446|NCT00942994|E2|Reported Event|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
283447|NCT00942994|E1|Reported Event|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
283448|NCT00941889|B3|Baseline|Total|Total of all reporting groups
283449|NCT00941889|B2|Baseline|Gardasil|Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
283450|NCT00941889|B1|Baseline|Placebo|Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
283451|NCT00941889|P2|Participant Flow|Gardasil Group|The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
283452|NCT00941889|P1|Participant Flow|Placebo|Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
283453|NCT00941889|O2|Outcome|Gardasil Group|Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
283454|NCT00941889|O1|Outcome|Placebo Group|Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.
283455|NCT00941889|E2|Reported Event|Treatment Group|The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
283456|NCT00941889|E1|Reported Event|Placebo|Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
283457|NCT00941863|B6|Baseline|Total|Total of all reporting groups
283458|NCT00941863|B5|Baseline|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
283459|NCT00941863|B4|Baseline|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
283460|NCT00941863|B3|Baseline|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
283461|NCT00941863|B2|Baseline|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
283462|NCT00941863|B1|Baseline|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
283463|NCT00941863|P5|Participant Flow|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
283464|NCT00941863|P4|Participant Flow|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
283465|NCT00941863|P3|Participant Flow|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
283466|NCT00941863|P2|Participant Flow|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
283467|NCT00941863|P1|Participant Flow|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
283468|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
283469|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
283470|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
283471|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
283472|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
283473|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
283474|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
283475|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
283476|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
283477|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
283478|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
283479|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
283482|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
283483|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
283484|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
283485|NCT00941863|O1|Outcome|Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid|All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid [twice daily], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
283486|NCT00941863|E5|Reported Event|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
283487|NCT00941863|E4|Reported Event|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
283488|NCT00941863|E3|Reported Event|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
283489|NCT00941863|E2|Reported Event|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
283490|NCT00941863|E1|Reported Event|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
283491|NCT00942903|B1|Baseline|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
283492|NCT00942903|P1|Participant Flow|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
283493|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
283494|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
283495|NCT00942903|E1|Reported Event|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
283496|NCT00942851|B3|Baseline|Total|Total of all reporting groups
283497|NCT00942851|B2|Baseline|Placebo|topical intervention WITHOUT AH-8
283498|NCT00942851|B1|Baseline|Active|AH-8 containing topical intervention
283499|NCT00942851|P2|Participant Flow|Placebo|"Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.~Twice daily application to the eyelids in standardized fashion."
283500|NCT00942851|P1|Participant Flow|Active|Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
283501|NCT00942851|O2|Outcome|Placebo|topical intervention WITHOUT AH-8
283502|NCT00942851|O1|Outcome|Active|AH-8 containing topical intervention
283503|NCT00942851|O2|Outcome|Placebo|
283504|NCT00942851|O1|Outcome|Active Ingredient- AH8|
283505|NCT00942851|O2|Outcome|Placebo|subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
283506|NCT00942851|O1|Outcome|Active Ingredient- AH8|subjects receiving active intervention, ie topical cream containing 0.005% AH-8
283507|NCT00942851|E2|Reported Event|Placebo|topical intervention WITHOUT AH-8
283508|NCT00942851|E1|Reported Event|Active|AH-8 containing topical intervention
283509|NCT00942786|B1|Baseline|One Arm|consecutive patients presenting for emergent non-cardiac surgery
283510|NCT00942786|P1|Participant Flow|No Treatment|Consecutive patients undergoing emergency surgery
283511|NCT00942786|O2|Outcome|Patients Not Sustaining Adverse Events|Subjects who did not reach the primary endpoint
283512|NCT00942786|O1|Outcome|Patients Sustaining Adverse Events|Subjects who reached the primary endpoint
283513|NCT00942786|O1|Outcome|All Patients|Consecutive patients undergoing emergent non-cardiac surgery
283514|NCT00942786|O1|Outcome|No Treatment|Consecutive patients undergoing emergency surgery
283515|NCT00942786|E1|Reported Event|One Arm|"consecutive patients presenting for emergent non-cardiac surgery~Patients were followed for occurence of major adverse cardiac events"
283516|NCT00942734|B1|Baseline|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
283517|NCT00942734|P1|Participant Flow|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
283518|NCT00942734|O1|Outcome|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
283519|NCT00942734|E1|Reported Event|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
283520|NCT00942604|B3|Baseline|Total|Total of all reporting groups
283521|NCT00942604|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
283522|NCT00942604|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
283523|NCT00942604|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
283524|NCT00942604|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
283525|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
283526|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
283527|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
283528|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
283529|NCT00942604|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
283530|NCT00942604|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
283531|NCT00942448|B5|Baseline|Total|Total of all reporting groups
283532|NCT00942448|B4|Baseline|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
283533|NCT00942448|B3|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283534|NCT00942448|B2|Baseline|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283535|NCT00942448|B1|Baseline|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283536|NCT00942448|P4|Participant Flow|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
283537|NCT00942448|P3|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283538|NCT00942448|P2|Participant Flow|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283539|NCT00942448|P1|Participant Flow|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283540|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
283541|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283542|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283543|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283544|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283545|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283546|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283547|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283548|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283549|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283550|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283551|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283552|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283553|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283554|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283555|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283556|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283557|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283558|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283559|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283560|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283561|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283562|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283563|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283564|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283565|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283566|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283567|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283568|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283569|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283570|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283571|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283572|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283573|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283574|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283575|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283576|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283577|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283578|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283579|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283580|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283581|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283582|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283583|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283584|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283585|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283586|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283587|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283588|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
283589|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
283590|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
283591|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
283592|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
283593|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283594|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283595|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283596|NCT00942448|E4|Reported Event|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
283597|NCT00942448|E3|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283598|NCT00942448|E2|Reported Event|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283599|NCT00942448|E1|Reported Event|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
283600|NCT00942422|B1|Baseline|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
283601|NCT00942422|P1|Participant Flow|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
283643|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283602|NCT00942422|O1|Outcome|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
283603|NCT00942422|E1|Reported Event|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
283604|NCT00942409|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
283605|NCT00942409|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
283606|NCT00942409|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
283607|NCT00942409|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
283608|NCT00942266|B3|Baseline|Total|Total of all reporting groups
283609|NCT00942266|B2|Baseline|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283610|NCT00942266|B1|Baseline|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283611|NCT00942266|P2|Participant Flow|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283612|NCT00942266|P1|Participant Flow|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283613|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283614|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283615|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283616|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283617|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283644|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283645|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283618|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283619|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283620|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283621|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283622|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283623|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283624|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283625|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283626|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283627|NCT00942266|E2|Reported Event|Arm II|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283628|NCT00942266|E1|Reported Event|Arm I|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
283629|NCT00942175|B5|Baseline|Total|Total of all reporting groups
283630|NCT00942175|B4|Baseline|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
283631|NCT00942175|B3|Baseline|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
283632|NCT00942175|B2|Baseline|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
283633|NCT00942175|B1|Baseline|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
283634|NCT00942175|P4|Participant Flow|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
283635|NCT00942175|P3|Participant Flow|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
283636|NCT00942175|P2|Participant Flow|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
283637|NCT00942175|P1|Participant Flow|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
283638|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283639|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283640|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283641|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283642|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283646|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283647|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283648|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283649|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283650|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283651|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283652|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283653|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283654|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283655|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283656|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283657|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283658|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283659|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283660|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283661|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283662|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283663|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283664|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283665|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283666|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283667|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283668|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283669|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283670|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283671|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283672|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283673|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283674|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283675|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283676|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283677|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283678|NCT00942175|E8|Reported Event|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
283679|NCT00942175|E7|Reported Event|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283680|NCT00942175|E6|Reported Event|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
283681|NCT00942175|E5|Reported Event|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283682|NCT00942175|E4|Reported Event|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
283683|NCT00942175|E3|Reported Event|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283684|NCT00942175|E2|Reported Event|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
283685|NCT00942175|E1|Reported Event|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
283686|NCT00942149|B1|Baseline|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
283687|NCT00942149|P1|Participant Flow|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
283688|NCT00942149|O1|Outcome|Area Under the Curve - 24 Hours|pharmacokinetics of daptomycin
283689|NCT00942149|E1|Reported Event|Daptomycin Cohort|
283690|NCT00942084|B1|Baseline|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283691|NCT00942084|P1|Participant Flow|Acyclovir Study Enrollment|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283692|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283693|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283694|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283695|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283696|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283697|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283698|NCT00942084|E1|Reported Event|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
283699|NCT00941993|B1|Baseline|Iontophoretic Delivery of Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283700|NCT00941993|P1|Participant Flow|Iontophoretic Delivery of Local Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283701|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283702|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283703|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283704|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283705|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283706|NCT00941993|E1|Reported Event|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
283707|NCT00941928|B1|Baseline|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
283708|NCT00941928|P1|Participant Flow|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
283709|NCT00941928|O1|Outcome|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
283710|NCT00941928|E1|Reported Event|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
283711|NCT00941798|B3|Baseline|Total|Total of all reporting groups
283712|NCT00941798|B2|Baseline|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283713|NCT00941798|B1|Baseline|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283714|NCT00941798|P2|Participant Flow|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283715|NCT00941798|P1|Participant Flow|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283716|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283717|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283718|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283719|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283720|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283721|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283722|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283723|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283724|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283725|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283726|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283727|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283728|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283729|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283730|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283731|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283732|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283733|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283734|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283735|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283736|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283737|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283738|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283739|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283740|NCT00941798|E2|Reported Event|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
283741|NCT00941798|E1|Reported Event|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
283742|NCT00941733|B3|Baseline|Total|Total of all reporting groups
283743|NCT00941733|B2|Baseline|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283744|NCT00941733|B1|Baseline|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283745|NCT00941733|P2|Participant Flow|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283746|NCT00941733|P1|Participant Flow|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283747|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283748|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283749|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283750|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283751|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283752|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283753|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283754|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283755|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283756|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283757|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283758|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283759|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283760|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283761|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283762|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283763|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283771|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283772|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283773|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283774|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283775|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283776|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283777|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283778|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283779|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283780|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283781|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283782|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283783|NCT00941733|E2|Reported Event|Standard PTA|Standard PTA balloon: Balloon Angioplasty
283784|NCT00941733|E1|Reported Event|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
283785|NCT00941720|B1|Baseline|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283786|NCT00941720|P1|Participant Flow|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283787|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283788|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283789|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283790|NCT00941720|E1|Reported Event|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
283791|NCT00941681|B4|Baseline|Total|Total of all reporting groups
283792|NCT00941681|B3|Baseline|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283793|NCT00941681|B2|Baseline|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283794|NCT00941681|B1|Baseline|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283795|NCT00941681|P3|Participant Flow|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283796|NCT00941681|P2|Participant Flow|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283797|NCT00941681|P1|Participant Flow|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283798|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283799|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283800|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283801|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283802|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283803|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283804|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283805|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283806|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283807|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283808|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283809|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283810|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283811|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283812|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283813|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283814|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283815|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283816|NCT00941681|E3|Reported Event|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
283894|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283817|NCT00941681|E2|Reported Event|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
283818|NCT00941681|E1|Reported Event|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
283819|NCT00941668|B3|Baseline|Total|Total of all reporting groups
283820|NCT00941668|B2|Baseline|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
283821|NCT00941668|B1|Baseline|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
283822|NCT00941668|P2|Participant Flow|Colgate Great Regular Flavor (Placebo)|sodium monofluorophosphate toothpaste
283823|NCT00941668|P1|Participant Flow|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
283824|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
283825|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
283826|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
283827|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
283828|NCT00941668|E2|Reported Event|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
283829|NCT00941668|E1|Reported Event|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
283830|NCT00941655|B3|Baseline|Total|Total of all reporting groups
283831|NCT00941655|B2|Baseline|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
283832|NCT00941655|B1|Baseline|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
283833|NCT00941655|P2|Participant Flow|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
283834|NCT00941655|P1|Participant Flow|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
283835|NCT00941655|O1|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
283836|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
283837|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
283838|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
283839|NCT00941655|E2|Reported Event|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
283840|NCT00941655|E1|Reported Event|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
283841|NCT00941603|B7|Baseline|Total|Total of all reporting groups
283842|NCT00941603|B6|Baseline|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
283843|NCT00941603|B5|Baseline|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283844|NCT00941603|B4|Baseline|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283845|NCT00941603|B3|Baseline|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283846|NCT00941603|B2|Baseline|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283847|NCT00941603|B1|Baseline|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283848|NCT00941603|P6|Participant Flow|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
283849|NCT00941603|P5|Participant Flow|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283850|NCT00941603|P4|Participant Flow|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283851|NCT00941603|P3|Participant Flow|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283852|NCT00941603|P2|Participant Flow|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283853|NCT00941603|P1|Participant Flow|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283854|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
283855|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283856|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283857|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283858|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283859|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283860|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
283861|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283862|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283863|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283864|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283865|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283866|NCT00941603|E6|Reported Event|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
283867|NCT00941603|E5|Reported Event|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283868|NCT00941603|E4|Reported Event|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283869|NCT00941603|E3|Reported Event|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283870|NCT00941603|E2|Reported Event|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283871|NCT00941603|E1|Reported Event|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
283872|NCT00941304|B6|Baseline|Total|Total of all reporting groups
283873|NCT00941304|B5|Baseline|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283874|NCT00941304|B4|Baseline|Placebo|Placebo oral capsule and 2 placebo buccal films
283875|NCT00941304|B3|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283876|NCT00941304|B2|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283877|NCT00941304|B1|Baseline|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283878|NCT00941304|P5|Participant Flow|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283879|NCT00941304|P4|Participant Flow|Placebo|Placebo oral capsule and 2 placebo buccal films
283880|NCT00941304|P3|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283881|NCT00941304|P2|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283882|NCT00941304|P1|Participant Flow|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283883|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283884|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283885|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283886|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283887|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283888|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283889|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283890|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283891|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283892|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283893|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283895|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283896|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283897|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283898|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283899|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283900|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283901|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283902|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283903|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283904|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283905|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283906|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283907|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283908|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283909|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283910|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283911|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283912|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283913|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283914|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283915|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283916|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283917|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283918|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283919|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283920|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283921|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283922|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283923|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283924|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283925|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283926|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283927|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283928|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283929|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283930|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283931|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283932|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283933|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283934|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
283935|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
283936|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283937|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283938|NCT00941304|E5|Reported Event|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
283939|NCT00941304|E4|Reported Event|Placebo|Placebo oral capsule and 2 placebo buccal films
283940|NCT00941304|E3|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
284541|NCT00939055|B2|Baseline|Sham Procedure|"No intervention~Sham procedure: False procedure"
283941|NCT00941304|E2|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283942|NCT00941304|E1|Reported Event|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
283943|NCT00941070|B1|Baseline|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283944|NCT00941070|P1|Participant Flow|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283945|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283946|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283947|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283948|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283949|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283950|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283951|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
284647|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
283952|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283953|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283954|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283955|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283956|NCT00941070|E1|Reported Event|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
283957|NCT00941031|B5|Baseline|Total|Total of all reporting groups
283958|NCT00941031|B4|Baseline|Placebo|
283959|NCT00941031|B3|Baseline|Induction Early Loading Dose|
283960|NCT00941031|B2|Baseline|Induction Monthly Dose|
283961|NCT00941031|B1|Baseline|Induction Single Dose|Baseline through Week 12
283962|NCT00941031|P7|Participant Flow|Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
283963|NCT00941031|P6|Participant Flow|Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
283964|NCT00941031|P5|Participant Flow|Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
283965|NCT00941031|P4|Participant Flow|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
283966|NCT00941031|P3|Participant Flow|Induction Early Loading|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
283967|NCT00941031|P2|Participant Flow|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
283968|NCT00941031|P1|Participant Flow|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
283969|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
283970|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
283971|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
283972|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
283973|NCT00941031|O3|Outcome|Maintenance Open Label|Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
283974|NCT00941031|O2|Outcome|Maintenance Start of Relapse|Treatment at start of relapse regimen – “SR”: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
284648|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
283975|NCT00941031|O1|Outcome|Maintenance Fixed Interval|Fixed-time interval regimen – “FI”: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
283976|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
283977|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
283978|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
283979|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
283980|NCT00941031|E10|Reported Event|FOLLOW-UP: Open Label|FOLLOW-UP: Open label
283981|NCT00941031|E9|Reported Event|FOLLOW-UP: Start of Relapse|FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
283982|NCT00941031|E8|Reported Event|FOLLOW-UP: Fixed Interval|FOLLOW-UP: Fixed-time interval regimen - 'FI'
283983|NCT00941031|E7|Reported Event|MAINTENANCE: Open Label|MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
283984|NCT00941031|E6|Reported Event|MAINTENANCE: Start of Relapse|MAINTENANCE: Treatment at start of relapse regimen - 'SR'
283985|NCT00941031|E5|Reported Event|MAINTENANCE: Fixed Interval|MAINTENANCE: Fixed-time interval regimen - 'FI'
283986|NCT00941031|E4|Reported Event|INDUCTION: Placebo|INDUCTION: Placebo - 'Placebo'
283987|NCT00941031|E3|Reported Event|INDUCTION: Early|INDUCTION: with single injection - 'Single'
283988|NCT00941031|E2|Reported Event|INDUCTION: Monthly|INDUCTION: with monthly injections - 'Monthly'
283989|NCT00941031|E1|Reported Event|INDUCTION: Single|INDUCTION: Early loading induction - 'Early'
283990|NCT00940992|B4|Baseline|Total|Total of all reporting groups
283991|NCT00940992|B3|Baseline|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
283992|NCT00940992|B2|Baseline|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
283993|NCT00940992|B1|Baseline|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
283994|NCT00940992|P3|Participant Flow|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
283995|NCT00940992|P2|Participant Flow|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
283996|NCT00940992|P1|Participant Flow|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
283997|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
283998|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
283999|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
284000|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
284001|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
284002|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
284003|NCT00940992|E3|Reported Event|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
284004|NCT00940992|E2|Reported Event|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
284005|NCT00940992|E1|Reported Event|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
284006|NCT00940927|B1|Baseline|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
284007|NCT00940927|P1|Participant Flow|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
284008|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
284009|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
284010|NCT00940927|E1|Reported Event|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
284011|NCT00940875|B3|Baseline|Total|Total of all reporting groups
284012|NCT00940875|B2|Baseline|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284013|NCT00940875|B1|Baseline|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284014|NCT00940875|P2|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E)|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284015|NCT00940875|P1|Participant Flow|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284219|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284016|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284017|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284018|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284019|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284020|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284021|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284022|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284023|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284024|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284025|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284026|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284027|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284028|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284029|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284030|NCT00940875|E2|Reported Event|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
284031|NCT00940875|E1|Reported Event|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
284032|NCT00940576|B1|Baseline|All Study Participants|Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
284033|NCT00940576|P2|Participant Flow|Oral Intake of Placebo First, Then Mare´s Milk|Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk
284034|NCT00940576|P1|Participant Flow|Oral Intake of Mare´s Milk First, Then Placebo|Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo
284035|NCT00940576|O2|Outcome|Patients Ulcerative Colitis|
284036|NCT00940576|O1|Outcome|Patients Crohn´s Disease|
284037|NCT00940576|O1|Outcome|Entire Study Population|oral intake of 250 ml mare´s milk or placebo drink daily
284038|NCT00940576|E2|Reported Event|Group 2|oral intake of 250 ml placebo daily
284039|NCT00940576|E1|Reported Event|Group 1|oral intake of 250 ml mare's milk daily
284040|NCT00940537|B3|Baseline|Total|Total of all reporting groups
284041|NCT00940537|B2|Baseline|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
284042|NCT00940537|B1|Baseline|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
284043|NCT00940537|P2|Participant Flow|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
284044|NCT00940537|P1|Participant Flow|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
289952|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
284045|NCT00940537|O1|Outcome|All Subjects|all subjects studied. This includes both lean and obese subjects with a range of intrahepatic triglyceride.
284046|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
284047|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
284048|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
284049|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
284050|NCT00940537|E2|Reported Event|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
284051|NCT00940537|E1|Reported Event|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
284052|NCT00940485|B3|Baseline|Total|Total of all reporting groups
284053|NCT00940485|B2|Baseline|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284054|NCT00940485|B1|Baseline|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284055|NCT00940485|P2|Participant Flow|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284056|NCT00940485|P1|Participant Flow|Peginterferon Alfa-2a + Entecavir|Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
284057|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284058|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284059|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284060|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284061|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284062|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284063|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284064|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284065|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284066|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284067|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284068|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284069|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284070|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284071|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284072|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284073|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284074|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284075|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284076|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284077|NCT00940485|E2|Reported Event|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
284078|NCT00940485|E1|Reported Event|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
284079|NCT00940290|B5|Baseline|Total|Total of all reporting groups
284080|NCT00940290|B4|Baseline|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
284081|NCT00940290|B3|Baseline|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
284082|NCT00940290|B2|Baseline|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
284083|NCT00940290|B1|Baseline|GRADE System|A clinical recommendation built and graded with the GRADE working group system
284084|NCT00940290|P4|Participant Flow|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
284085|NCT00940290|P3|Participant Flow|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
284086|NCT00940290|P2|Participant Flow|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
284087|NCT00940290|P1|Participant Flow|GRADE System|A clinical recommendation built and graded with the GRADE working group system
284088|NCT00940290|O4|Outcome|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
284089|NCT00940290|O3|Outcome|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
284090|NCT00940290|O2|Outcome|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
284091|NCT00940290|O1|Outcome|GRADE System|A clinical recommendation built and graded with the GRADE working group system
284092|NCT00940290|E4|Reported Event|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
284093|NCT00940290|E3|Reported Event|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
284094|NCT00940290|E2|Reported Event|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
284095|NCT00940290|E1|Reported Event|GRADE System|A clinical recommendation built and graded with the GRADE working group system
284096|NCT00940108|B5|Baseline|Total|Total of all reporting groups
284097|NCT00940108|B4|Baseline|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284098|NCT00940108|B3|Baseline|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284099|NCT00940108|B2|Baseline|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284100|NCT00940108|B1|Baseline|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284101|NCT00940108|P4|Participant Flow|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284102|NCT00940108|P3|Participant Flow|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284103|NCT00940108|P2|Participant Flow|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284104|NCT00940108|P1|Participant Flow|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284105|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284106|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284107|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284108|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284109|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284110|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284111|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284112|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284113|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284114|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284115|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284116|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284117|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284118|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284119|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
289953|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
284120|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284121|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284122|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284123|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284124|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284125|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284126|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284127|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284128|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284129|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284130|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284131|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284132|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284133|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284134|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284135|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284136|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284137|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284138|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284139|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284140|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284141|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284142|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284143|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284144|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284145|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284146|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284147|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284148|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284149|NCT00940108|E4|Reported Event|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284150|NCT00940108|E3|Reported Event|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284151|NCT00940108|E2|Reported Event|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284152|NCT00940108|E1|Reported Event|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
284153|NCT00940017|B1|Baseline|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284154|NCT00940017|P1|Participant Flow|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284155|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284156|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284157|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284158|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284159|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284160|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284161|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284162|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284163|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284181|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284164|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284165|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284166|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284167|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284168|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284169|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284170|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284171|NCT00940017|E1|Reported Event|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
284172|NCT00939991|B3|Baseline|Total|Total of all reporting groups
284173|NCT00939991|B2|Baseline|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284174|NCT00939991|B1|Baseline|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
284175|NCT00939991|P2|Participant Flow|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284176|NCT00939991|P1|Participant Flow|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
284177|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284178|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284179|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284180|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284218|NCT00939796|P1|Participant Flow|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284182|NCT00939991|O1|Outcome|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
284183|NCT00939991|E2|Reported Event|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
284184|NCT00939991|E1|Reported Event|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
284185|NCT00939952|B1|Baseline|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284186|NCT00939952|P1|Participant Flow|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284187|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284188|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284189|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284190|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284191|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284192|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284193|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284194|NCT00939952|E1|Reported Event|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
284195|NCT00939900|B3|Baseline|Total|Total of all reporting groups
284196|NCT00939900|B2|Baseline|Control|control group
284197|NCT00939900|B1|Baseline|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
284198|NCT00939900|P2|Participant Flow|Control|control group
284199|NCT00939900|P1|Participant Flow|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
284200|NCT00939900|O2|Outcome|Control|control group
284201|NCT00939900|O1|Outcome|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
284202|NCT00939900|E2|Reported Event|Control|control group
284203|NCT00939900|E1|Reported Event|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
284204|NCT00939874|B1|Baseline|Raltegravir|Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
284205|NCT00939874|P1|Participant Flow|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
284206|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
284207|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
284208|NCT00939874|E1|Reported Event|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
284209|NCT00939809|B1|Baseline|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284210|NCT00939809|P1|Participant Flow|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284211|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284212|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284213|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284214|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284215|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284216|NCT00939809|E1|Reported Event|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
284217|NCT00939796|B1|Baseline|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284220|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284221|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284222|NCT00939796|E1|Reported Event|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
284223|NCT00939783|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284224|NCT00939783|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284225|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284226|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284227|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284228|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284229|NCT00939783|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
284230|NCT00939731|B1|Baseline|Entire Study Population|Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
284231|NCT00939731|P2|Participant Flow|PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
284232|NCT00939731|P1|Participant Flow|PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
284233|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284234|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284235|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284236|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284237|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284238|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284239|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284240|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284241|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284242|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284243|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284244|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284245|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284246|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284247|NCT00939731|E2|Reported Event|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
284248|NCT00939731|E1|Reported Event|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
284249|NCT00939705|B3|Baseline|Total|Total of all reporting groups
284250|NCT00939705|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
284251|NCT00939705|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
284252|NCT00939705|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
284367|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284253|NCT00939705|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
284254|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
284255|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
284256|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
284257|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
284258|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
284259|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
284260|NCT00939705|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
284261|NCT00939705|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
284262|NCT00939692|B3|Baseline|Total|Total of all reporting groups
284263|NCT00939692|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
284264|NCT00939692|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
284265|NCT00939692|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
284266|NCT00939692|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
284267|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
284268|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
284269|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
284270|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
284271|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
284272|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
284273|NCT00939692|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
284274|NCT00939692|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
284275|NCT00939627|B3|Baseline|Total|Total of all reporting groups
284276|NCT00939627|B2|Baseline|Arm B - Cetuximab and Sorafenib Tosylate|Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
284277|NCT00939627|B1|Baseline|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284278|NCT00939627|P3|Participant Flow|Participants Who Did Not Receive Treatment.|Placebo Arm: The protocol was amended and this arm was removed.
284279|NCT00939627|P2|Participant Flow|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284280|NCT00939627|P1|Participant Flow|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
284281|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284282|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284283|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284284|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284285|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284286|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284287|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284324|NCT00939484|B1|Baseline|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
284288|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284289|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
284290|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284291|NCT00939627|E2|Reported Event|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
284292|NCT00939627|E1|Reported Event|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
284293|NCT00939562|B1|Baseline|Entire Study Population|Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
284294|NCT00939562|P2|Participant Flow|Doxycycline Carragenate, Then Doxycycline Monohydrate|Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
284295|NCT00939562|P1|Participant Flow|Doxycycline Monohydrate, Then Doxycycline Carragenate|Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
284296|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
284297|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
284298|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
284299|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
284300|NCT00939562|E2|Reported Event|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
284301|NCT00939562|E1|Reported Event|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
284302|NCT00939536|B3|Baseline|Total|Total of all reporting groups
284303|NCT00939536|B2|Baseline|Active Comparator|Ambien® 10mg tablets
284304|NCT00939536|B1|Baseline|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284305|NCT00939536|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
284306|NCT00939536|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
284307|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284308|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284309|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284310|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284311|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284312|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284313|NCT00939536|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
284314|NCT00939536|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284315|NCT00939510|B1|Baseline|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284316|NCT00939510|P1|Participant Flow|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284317|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284318|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284319|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284320|NCT00939510|E1|Reported Event|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
284321|NCT00939484|B4|Baseline|Total|Total of all reporting groups
284322|NCT00939484|B3|Baseline|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
284323|NCT00939484|B2|Baseline|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284325|NCT00939484|P3|Participant Flow|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
284326|NCT00939484|P2|Participant Flow|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284327|NCT00939484|P1|Participant Flow|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
284328|NCT00939484|O1|Outcome|PBTC025B|Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
284329|NCT00939484|O1|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284330|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
284331|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284332|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
284333|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
284334|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284335|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
284336|NCT00939484|E3|Reported Event|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
284337|NCT00939484|E2|Reported Event|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
284338|NCT00939484|E1|Reported Event|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
284339|NCT00939471|B1|Baseline|Balloon Device|Balloon catheter dilation of sinus ostia
284340|NCT00939471|P1|Participant Flow|Balloon Device|Balloon catheter dilation of sinus ostia
284341|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284342|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284343|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284344|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284345|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284346|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284347|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284348|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
284349|NCT00939471|E1|Reported Event|Balloon Device|Balloon catheter dilation of sinus ostia
284350|NCT00939393|B3|Baseline|Total|Total of all reporting groups
284351|NCT00939393|B2|Baseline|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284352|NCT00939393|B1|Baseline|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284353|NCT00939393|P2|Participant Flow|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284354|NCT00939393|P1|Participant Flow|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284355|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery (ESS) performed in the operating room (OR) with or without balloon sinus dilation devices.
284356|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery (ESS) performed in physician's office (IO, or In Office) using balloon sinus dilation device.
284357|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284358|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284359|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284360|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284361|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284362|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284363|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284364|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284365|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284366|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284533|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284368|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284369|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284370|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284371|NCT00939393|E2|Reported Event|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
284372|NCT00939393|E1|Reported Event|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
284373|NCT00939367|B1|Baseline|All Study Participants|Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
284374|NCT00939367|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
284375|NCT00939367|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
284376|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284377|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284378|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284379|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284380|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
284381|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284382|NCT00939367|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
284383|NCT00939367|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
284384|NCT00939341|B1|Baseline|Symbicort Turbuhaler|160/4.5 µg delivered dose
284385|NCT00939341|P1|Participant Flow|Symbicort Turbuhaler|160/4.5 µg delivered dose
284386|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284387|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284388|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284389|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284390|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284391|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284392|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284393|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284394|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284395|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284396|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284397|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284398|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284399|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284400|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284401|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284402|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
284403|NCT00939341|E1|Reported Event|Symbicort Turbuhaler|160/4.5 µg delivered dose
284404|NCT00939211|B1|Baseline|Overall Number of Baseline Participants|
284405|NCT00939211|P1|Participant Flow|Entire Study Population|
284406|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284407|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284408|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284409|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284410|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284411|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284412|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284413|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284414|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284415|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284416|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284417|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284418|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284419|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284420|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284421|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284422|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284423|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284424|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284425|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284426|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284427|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284428|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284429|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284430|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284431|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284432|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284433|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284434|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284435|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284436|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284437|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284438|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284439|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284440|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284441|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284442|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284443|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284444|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284445|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284446|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284447|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284448|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284449|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284450|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284451|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284452|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284453|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284454|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284455|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284456|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284457|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284458|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284459|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284460|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284461|NCT00939211|E5|Reported Event|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
284462|NCT00939211|E4|Reported Event|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
284463|NCT00939211|E3|Reported Event|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284464|NCT00939211|E2|Reported Event|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284465|NCT00939211|E1|Reported Event|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
284466|NCT00939185|B1|Baseline|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284467|NCT00939185|P1|Participant Flow|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284468|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284469|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284470|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284471|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284472|NCT00939185|E1|Reported Event|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
284473|NCT00939159|B1|Baseline|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
284474|NCT00939159|P1|Participant Flow|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
284475|NCT00939159|O1|Outcome|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
284476|NCT00939159|E1|Reported Event|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
284477|NCT00939120|B3|Baseline|Total|Total of all reporting groups
284478|NCT00939120|B2|Baseline|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284479|NCT00939120|B1|Baseline|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284480|NCT00939120|P2|Participant Flow|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284481|NCT00939120|P1|Participant Flow|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284482|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284534|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284483|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284484|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284485|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284486|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284487|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284488|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284489|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284490|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284491|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284492|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284493|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284494|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284495|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284496|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284497|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284498|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284499|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284500|NCT00939120|E2|Reported Event|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
284501|NCT00939120|E1|Reported Event|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
284502|NCT00939107|B3|Baseline|Total|Total of all reporting groups
284503|NCT00939107|B2|Baseline|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284504|NCT00939107|B1|Baseline|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284505|NCT00939107|P2|Participant Flow|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284506|NCT00939107|P1|Participant Flow|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284507|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284508|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284509|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284510|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284511|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284512|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284513|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284514|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284515|NCT00939107|E2|Reported Event|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
284516|NCT00939107|E1|Reported Event|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
284517|NCT00939094|B3|Baseline|Total|Total of all reporting groups
284518|NCT00939094|B2|Baseline|2 - Placebo|Placebo, capsule
284519|NCT00939094|B1|Baseline|A - AZD2066|AZD2066, 12 mg capsule
284520|NCT00939094|P2|Participant Flow|2 - Placebo|Placebo, capsule
284521|NCT00939094|P1|Participant Flow|A - AZD2066|AZD2066, 12 mg capsule
284522|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284523|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284524|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284525|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284526|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284527|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284528|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284529|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284530|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284531|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
284532|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
284542|NCT00939055|B1|Baseline|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
284543|NCT00939055|P2|Participant Flow|Sham Procedure|"No intervention~Sham procedure: False procedure"
284544|NCT00939055|P1|Participant Flow|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
284545|NCT00939055|O2|Outcome|Sham Procedure|"No intervention~Sham procedure: False procedure"
284546|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
284547|NCT00939055|O2|Outcome|Sham|No intervention
284548|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
284549|NCT00939055|E2|Reported Event|Sham|No intervention
284550|NCT00939055|E1|Reported Event|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
284551|NCT00939029|B3|Baseline|Total|Total of all reporting groups
284552|NCT00939029|B2|Baseline|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284553|NCT00939029|B1|Baseline|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284554|NCT00939029|P2|Participant Flow|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284555|NCT00939029|P1|Participant Flow|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284556|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284557|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284558|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284559|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284560|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284561|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284562|NCT00939029|E2|Reported Event|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
284563|NCT00939029|E1|Reported Event|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
284564|NCT00939003|B3|Baseline|Total|Total of all reporting groups
284565|NCT00939003|B2|Baseline|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284566|NCT00939003|B1|Baseline|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284567|NCT00939003|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284568|NCT00939003|P1|Participant Flow|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284569|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284570|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284571|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284572|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284573|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284574|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
284575|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284576|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284577|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284578|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284579|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284580|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284581|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284582|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284583|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284584|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284585|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284586|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284587|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284588|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284589|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284590|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284591|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284592|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284593|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284594|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284595|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284596|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284597|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
284598|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
284599|NCT00939003|E3|Reported Event|Any Adalimumab|Participants who received any dose of adalimumab during the 12-week double-blind period or during the 144-week open-label period.
284600|NCT00939003|E2|Reported Event|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period.
284601|NCT00939003|E1|Reported Event|Double-blind Placebo|Participants received placebo every other week for 12 weeks during the double-blind period.
284602|NCT00938860|B3|Baseline|Total|Total of all reporting groups
284603|NCT00938860|B2|Baseline|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284604|NCT00938860|B1|Baseline|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284605|NCT00938860|P2|Participant Flow|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284606|NCT00938860|P1|Participant Flow|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284607|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284608|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284609|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284610|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284611|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284612|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284613|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284614|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
289954|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
284615|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284616|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284617|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284618|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284619|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284620|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284621|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284622|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284623|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284624|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284625|NCT00938860|E2|Reported Event|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
284626|NCT00938860|E1|Reported Event|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
284627|NCT00938782|B3|Baseline|Total|Total of all reporting groups
284628|NCT00938782|B2|Baseline|2 - CONTROL Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)"
284629|NCT00938782|B1|Baseline|1 - SEDLine™ Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group)."
284630|NCT00938782|P2|Participant Flow|2- Control Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
284631|NCT00938782|P1|Participant Flow|1 - SEDLine™ Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
284632|NCT00938782|O2|Outcome|2 - Control Group|Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
284633|NCT00938782|O1|Outcome|1 - Sedline Group|Patient group randomized to active monitoring with Sedline monitor.
284634|NCT00938782|E2|Reported Event|Group 2 - Control Group|Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
284635|NCT00938782|E1|Reported Event|1 - SEDLine Group|Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia.
284636|NCT00938717|B3|Baseline|Total|Total of all reporting groups
284637|NCT00938717|B2|Baseline|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284638|NCT00938717|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
284639|NCT00938717|P2|Participant Flow|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284640|NCT00938717|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
284641|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284642|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284643|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284644|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284645|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284646|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
289955|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
284649|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284650|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284651|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284652|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284653|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284654|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284655|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284656|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284657|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284658|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284659|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284660|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284661|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284662|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284663|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284664|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284665|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284666|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284667|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284668|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
284669|NCT00938717|E2|Reported Event|Linaclotide|Linaclotide 290μg, oral administration, once per day.
284670|NCT00938717|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
284671|NCT00938704|B3|Baseline|Total|Total of all reporting groups
284672|NCT00938704|B2|Baseline|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284673|NCT00938704|B1|Baseline|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284674|NCT00938704|P2|Participant Flow|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284675|NCT00938704|P1|Participant Flow|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284676|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284677|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284678|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284679|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284680|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284681|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284682|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284683|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284684|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284685|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284686|NCT00938704|E2|Reported Event|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
284687|NCT00938704|E1|Reported Event|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
284688|NCT00938639|B3|Baseline|Total|Total of all reporting groups
284689|NCT00938639|B2|Baseline|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284690|NCT00938639|B1|Baseline|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284691|NCT00938639|P2|Participant Flow|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284692|NCT00938639|P1|Participant Flow|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284693|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284694|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284695|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284696|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284697|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284698|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284699|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284700|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284701|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284702|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284703|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284704|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284705|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284706|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284707|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284708|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284709|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284710|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284711|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284712|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284713|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284714|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284715|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284716|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284717|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284718|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284719|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284720|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284721|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284722|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284723|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284724|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284725|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284726|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284727|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284728|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284729|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284730|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284731|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284732|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284733|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284734|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284735|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284736|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284737|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284738|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284739|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284740|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284741|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284742|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284743|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284744|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284745|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284746|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284747|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284748|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284749|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284750|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284751|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284752|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284753|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284754|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284755|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284756|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284757|NCT00938639|E2|Reported Event|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284758|NCT00938639|E1|Reported Event|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
284759|NCT00938548|B3|Baseline|Total|Total of all reporting groups
284760|NCT00938548|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284761|NCT00938548|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284762|NCT00938548|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284763|NCT00938548|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284764|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284765|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284766|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284767|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284768|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284769|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284770|NCT00938548|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
284771|NCT00938548|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
284772|NCT00938457|B1|Baseline|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284773|NCT00938457|P1|Participant Flow|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284774|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284775|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284776|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284777|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284816|NCT00938392|B2|Baseline|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284817|NCT00938392|B1|Baseline|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284778|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284779|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284780|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284781|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284782|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284783|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284784|NCT00938457|E1|Reported Event|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
284785|NCT00938431|B4|Baseline|Total Title|
284786|NCT00938431|B3|Baseline|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284787|NCT00938431|B2|Baseline|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284788|NCT00938431|B1|Baseline|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284789|NCT00938431|P3|Participant Flow|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284790|NCT00938431|P2|Participant Flow|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284791|NCT00938431|P1|Participant Flow|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284792|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284793|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284794|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284795|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284796|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284797|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284798|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284799|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
284800|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284801|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284802|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284803|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284804|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284805|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284806|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284807|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284808|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284809|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284810|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284811|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284812|NCT00938431|E3|Reported Event|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284813|NCT00938431|E2|Reported Event|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284814|NCT00938431|E1|Reported Event|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
284815|NCT00938392|B3|Baseline|Total|Total of all reporting groups
285444|NCT00936208|B1|Baseline|Micardis 80mg|One tablet of Micardis 80mg per day
284818|NCT00938392|P2|Participant Flow|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284819|NCT00938392|P1|Participant Flow|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284820|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284821|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284822|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284823|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284824|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284825|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284826|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284827|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284828|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284829|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284830|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284831|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284832|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284833|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284834|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284835|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284836|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284837|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284838|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284839|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284840|NCT00938392|E2|Reported Event|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
284841|NCT00938392|E1|Reported Event|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
284842|NCT00938366|B3|Baseline|Total|Total of all reporting groups
284843|NCT00938366|B2|Baseline|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
284844|NCT00938366|B1|Baseline|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
284845|NCT00938366|P2|Participant Flow|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
284846|NCT00938366|P1|Participant Flow|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
284847|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284848|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284849|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284850|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284851|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284852|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284853|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284854|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284855|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284856|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284857|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284858|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284859|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284860|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284861|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284862|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284863|NCT00938366|E2|Reported Event|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
284864|NCT00938366|E1|Reported Event|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
284865|NCT00938327|B1|Baseline|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284866|NCT00938327|P1|Participant Flow|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284867|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284868|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284869|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284870|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284871|NCT00938327|E1|Reported Event|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
284872|NCT00938314|B5|Baseline|Total|Total of all reporting groups
284873|NCT00938314|B4|Baseline|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284874|NCT00938314|B3|Baseline|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284875|NCT00938314|B2|Baseline|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284876|NCT00938314|B1|Baseline|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284877|NCT00938314|P4|Participant Flow|Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284878|NCT00938314|P3|Participant Flow|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284879|NCT00938314|P2|Participant Flow|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284880|NCT00938314|P1|Participant Flow|NTx®-265 Low Dose|human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
284881|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284882|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284883|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284884|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284885|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284886|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284887|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284888|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284889|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284890|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284891|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284892|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284893|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284894|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284895|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284896|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284897|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284898|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284899|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284900|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284901|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284902|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284903|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284904|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284905|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284906|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284907|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284908|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284909|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284910|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284911|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284912|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284913|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284914|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284915|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284916|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284917|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284918|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284919|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284920|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284921|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284922|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284923|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284924|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284925|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284926|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
289956|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
284927|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284928|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284929|NCT00938314|E4|Reported Event|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
284930|NCT00938314|E3|Reported Event|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
284931|NCT00938314|E2|Reported Event|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
284932|NCT00938314|E1|Reported Event|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
284933|NCT00938041|B1|Baseline|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284934|NCT00938041|P1|Participant Flow|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284935|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284936|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284937|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284938|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284963|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284964|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
285371|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 12 months after index event in telemedicine group
284939|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284940|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284941|NCT00938041|E1|Reported Event|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
284942|NCT00938015|B1|Baseline|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284943|NCT00938015|P1|Participant Flow|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284944|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284945|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284946|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284947|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284948|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284949|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284950|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284951|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284952|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284953|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284954|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284955|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284956|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284957|NCT00938015|E1|Reported Event|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
284958|NCT00937950|B1|Baseline|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284959|NCT00937950|P1|Participant Flow|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284960|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284961|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284962|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
285026|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
284965|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284966|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284967|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284968|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284969|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284970|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284971|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284972|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284973|NCT00937950|E1|Reported Event|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
284974|NCT00937937|B1|Baseline|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
284975|NCT00937937|P1|Participant Flow|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
284976|NCT00937937|O1|Outcome|Dinaciclib|
284977|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
284978|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
284979|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
284980|NCT00937937|E1|Reported Event|SCH 727965|
284981|NCT00937833|B3|Baseline|Total|Total of all reporting groups
284982|NCT00937833|B2|Baseline|Control|No sling placed at the time of prostatectomy
284983|NCT00937833|B1|Baseline|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
284984|NCT00937833|P2|Participant Flow|Control|No sling placed at the time of prostatectomy
284985|NCT00937833|P1|Participant Flow|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
284986|NCT00937833|O2|Outcome|Control|No sling placed at the time of prostatectomy
284987|NCT00937833|O1|Outcome|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
284988|NCT00937833|E2|Reported Event|Control|No sling placed at the time of prostatectomy
284989|NCT00937833|E1|Reported Event|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
284990|NCT00937794|B1|Baseline|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
284991|NCT00937794|P1|Participant Flow|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
284992|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
284993|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
284994|NCT00937794|E1|Reported Event|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
284995|NCT00937768|B3|Baseline|Total|Total of all reporting groups
284996|NCT00937768|B2|Baseline|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
284997|NCT00937768|B1|Baseline|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
284998|NCT00937768|P2|Participant Flow|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
284999|NCT00937768|P1|Participant Flow|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
285000|NCT00937768|O2|Outcome|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
285001|NCT00937768|O1|Outcome|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
285002|NCT00937768|E2|Reported Event|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
285003|NCT00937768|E1|Reported Event|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
285027|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285372|NCT00936455|O2|Outcome|Telephone|Assessing number of recurrent strokes by 12 months
285004|NCT00937560|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285005|NCT00937560|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285006|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285007|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285008|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Only participants with measureable disease were included in the analysis according to RECIST only. Only participants with an ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal were included in the analysis according to CA-125 level only.
285009|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285010|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
285011|NCT00937560|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|"Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.~Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion.~Paclitaxel: Paclitaxel was supplied locally in commercial batches.~Carboplatin: Carboplatin was supplied locally in commercial batches."
285012|NCT00937547|B4|Baseline|Total|Total of all reporting groups
285013|NCT00937547|B3|Baseline|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
285014|NCT00937547|B2|Baseline|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
285015|NCT00937547|B1|Baseline|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
285016|NCT00937547|P3|Participant Flow|Cervical Intraepithelial Neoplasia 3|patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
285017|NCT00937547|P2|Participant Flow|Cervical Intraepithelial Neoplasia 2|patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
285018|NCT00937547|P1|Participant Flow|Invasive Cervical Cancer|patients with histologic diagnosis invasive cervical cancer.
285019|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285020|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285021|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285022|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285023|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285024|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285025|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285299|NCT00937040|E1|Reported Event|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285028|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285029|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285030|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285031|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285032|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285033|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285034|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285035|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285036|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285037|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285038|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285039|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285040|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
285041|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
285042|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
285043|NCT00937547|E3|Reported Event|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
285044|NCT00937547|E2|Reported Event|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
285045|NCT00937547|E1|Reported Event|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
285046|NCT00937521|B9|Baseline|Total|Total of all reporting groups
285047|NCT00937521|B8|Baseline|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285048|NCT00937521|B7|Baseline|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285049|NCT00937521|B6|Baseline|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285050|NCT00937521|B5|Baseline|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285051|NCT00937521|B4|Baseline|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285052|NCT00937521|B3|Baseline|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285053|NCT00937521|B2|Baseline|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285054|NCT00937521|B1|Baseline|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285055|NCT00937521|P8|Participant Flow|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285056|NCT00937521|P7|Participant Flow|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285057|NCT00937521|P6|Participant Flow|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285058|NCT00937521|P5|Participant Flow|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285059|NCT00937521|P4|Participant Flow|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285060|NCT00937521|P3|Participant Flow|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285061|NCT00937521|P2|Participant Flow|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285440|NCT00936221|E2|Reported Event|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
285062|NCT00937521|P1|Participant Flow|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285063|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285064|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285065|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285066|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285067|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285068|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285069|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285070|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285071|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285072|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285073|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285074|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285075|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285076|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285077|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285078|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285079|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285080|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285081|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285082|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285083|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285084|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285085|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285086|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285087|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285088|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285300|NCT00936975|B1|Baseline|Overall|Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
285089|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285090|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285091|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285092|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285093|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285094|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285095|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285096|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285097|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285098|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285099|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285100|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285101|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285102|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285103|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285104|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285105|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285106|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
285107|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285108|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285109|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285110|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285111|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
285112|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285113|NCT00937521|O2|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285114|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285115|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285116|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285117|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285118|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285119|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285120|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285121|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285122|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285123|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285124|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285125|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285126|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285127|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
285128|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285129|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285130|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
285131|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285132|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285133|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285134|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285135|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285136|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285137|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285138|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285139|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285140|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285141|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285142|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285143|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
285144|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
285145|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285146|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285147|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285148|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285149|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285150|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285151|NCT00937521|E16|Reported Event|Par+B+OMV (Group VIII) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
285152|NCT00937521|E15|Reported Event|MenC (Group VII) Booster Phase|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to include Booster Phase."
285153|NCT00937521|E14|Reported Event|PH2 B+OMV (Group VI) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
285154|NCT00937521|E13|Reported Event|½ (B+OMV) (Group V) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
285155|NCT00937521|E12|Reported Event|B (Group IV) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
285156|NCT00937521|E11|Reported Event|B+1/4 OMV (Group III) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
285157|NCT00937521|E10|Reported Event|B+½ OMV (Group II) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
285158|NCT00937521|E9|Reported Event|B+OMV (Group I) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
285159|NCT00937521|E8|Reported Event|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
285160|NCT00937521|E7|Reported Event|MenC (Group VII)|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285161|NCT00937521|E6|Reported Event|PH2 B+OMV (Group VI)|"SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285162|NCT00937521|E5|Reported Event|½ (B+OMV) (Group V)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285163|NCT00937521|E4|Reported Event|B (Group IV)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting.."
285164|NCT00937521|E3|Reported Event|B+1/4 OMV (Group III)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285165|NCT00937521|E2|Reported Event|B+½ OMV (Group II)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285166|NCT00937521|E1|Reported Event|B+OMV (Group I)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
285167|NCT00937495|B1|Baseline|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285168|NCT00937495|P1|Participant Flow|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285169|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285170|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285171|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285172|NCT00937495|E1|Reported Event|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
285173|NCT00937391|B3|Baseline|Total|Total of all reporting groups
285174|NCT00937391|B2|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) – Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285175|NCT00937391|B1|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285176|NCT00937391|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-6661)|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285177|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285178|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285179|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285180|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285181|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285182|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285183|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285184|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285185|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285186|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285187|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285188|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285189|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285190|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285191|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285192|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285193|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285194|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
289957|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
285195|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285196|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285197|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285198|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285199|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285200|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285201|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285202|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285203|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285204|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285205|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285206|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285207|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285208|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285209|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285210|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285211|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285212|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
285213|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285214|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285215|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285216|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285217|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285218|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285219|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285220|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285221|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285222|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285223|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
285224|NCT00937391|E2|Reported Event|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
285225|NCT00937391|E1|Reported Event|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
285226|NCT00937157|B1|Baseline|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
285227|NCT00937157|P1|Participant Flow|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
285228|NCT00937157|O1|Outcome|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
285229|NCT00937157|E1|Reported Event|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
285230|NCT00937118|B1|Baseline|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
285231|NCT00937118|P1|Participant Flow|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
285232|NCT00937118|O4|Outcome|Fascial Closure|Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
285233|NCT00937118|O3|Outcome|Damage Control|Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
285234|NCT00937118|O2|Outcome|Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
285235|NCT00937118|O1|Outcome|No Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
285236|NCT00937118|E1|Reported Event|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
285237|NCT00937105|B3|Baseline|Total|Total of all reporting groups
285238|NCT00937105|B2|Baseline|Lotrafilcon A and Clear Care|
285239|NCT00937105|B1|Baseline|Lotrafilcon A and Renu|
285240|NCT00937105|P2|Participant Flow|Lotrafilcon A Lenses and Renu Multiplus|
285241|NCT00937105|P1|Participant Flow|Lotrafilcon A Lenses and Clear Care|
285242|NCT00937105|O2|Outcome|Participants With no CNS Bioburden on Lid Margins|
285243|NCT00937105|O1|Outcome|Participants With CNS Bioburden on Lid Margins|
285244|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lid Margins|
285245|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lid Margins|
285246|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lens Cases|
285247|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lens Cases|
285248|NCT00937105|O2|Outcome|Participants Without Corneal Staining|
285249|NCT00937105|O1|Outcome|Participants With Corneal Staining|
285250|NCT00937105|O2|Outcome|Participants Without Microbial Bioburden on Lenses|
285251|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lenses|
285252|NCT00937105|O2|Outcome|Lotrafilcon A Lenses and Clear Care|
285253|NCT00937105|O1|Outcome|Lotrafilcon A Lenses and Renu|
285254|NCT00937105|E1|Reported Event|Entire Cohort of Lotrafilcon A Users|
285255|NCT00937040|B3|Baseline|Total|Total of all reporting groups
285441|NCT00936221|E1|Reported Event|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
285256|NCT00937040|B2|Baseline|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285257|NCT00937040|B1|Baseline|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285258|NCT00937040|P2|Participant Flow|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285259|NCT00937040|P1|Participant Flow|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285260|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285261|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285262|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285263|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285264|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285265|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285266|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285267|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285268|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285269|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285270|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285271|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285272|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285273|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285274|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285275|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285276|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285277|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285278|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285279|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285280|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285281|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285282|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285283|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285284|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285285|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285286|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285287|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285288|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285289|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285290|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285291|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285292|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285293|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285294|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285295|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285296|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285297|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
285298|NCT00937040|E2|Reported Event|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
285301|NCT00936975|P1|Participant Flow|Overall|Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib
285302|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
285303|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
285304|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
285305|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
285306|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
285307|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
285308|NCT00936975|E1|Reported Event|Overall|Participants receiving 100mg PO QD Dasatinib
285309|NCT00936897|B3|Baseline|Total|Total of all reporting groups
285310|NCT00936897|B2|Baseline|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285311|NCT00936897|B1|Baseline|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285312|NCT00936897|P2|Participant Flow|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285313|NCT00936897|P1|Participant Flow|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285314|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285315|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285316|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285317|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285318|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285319|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285320|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285321|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285322|NCT00936897|E2|Reported Event|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
285323|NCT00936897|E1|Reported Event|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
285324|NCT00936741|B1|Baseline|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
285325|NCT00936741|P1|Participant Flow|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
285326|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
285327|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
285328|NCT00936741|E1|Reported Event|Mifepristone 300 to 1200 mg Daily|mifepristone at doses from 300 mg/day to 1200 mg/day
285329|NCT00936702|B1|Baseline|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285330|NCT00936702|P1|Participant Flow|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285331|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285332|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285333|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285334|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285335|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285336|NCT00936702|E1|Reported Event|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
285337|NCT00936598|B3|Baseline|Total|Total of all reporting groups
285338|NCT00936598|B2|Baseline|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285339|NCT00936598|B1|Baseline|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285369|NCT00936455|P1|Participant Flow|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
285340|NCT00936598|P2|Participant Flow|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285341|NCT00936598|P1|Participant Flow|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285342|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285343|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285344|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285345|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285346|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285347|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285348|NCT00936598|E2|Reported Event|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285349|NCT00936598|E1|Reported Event|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
285350|NCT00936585|B1|Baseline|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
285351|NCT00936585|P1|Participant Flow|Immunologic Monitoring|All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
285352|NCT00936585|O1|Outcome|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
285353|NCT00936585|E1|Reported Event|Colonoscopy|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
285354|NCT00936481|B3|Baseline|Total|Total of all reporting groups
285355|NCT00936481|B2|Baseline|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
285356|NCT00936481|B1|Baseline|Healthy Controls|18 years or older with body mass index between 25-45
285357|NCT00936481|P2|Participant Flow|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
285358|NCT00936481|P1|Participant Flow|Healthy Controls|18 years or older with body mass index between 25-45
285359|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
285360|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
285361|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
285362|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
285363|NCT00936481|E2|Reported Event|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
285364|NCT00936481|E1|Reported Event|Healthy Controls|18 years or older with body mass index between 25-45
285365|NCT00936455|B3|Baseline|Total|Total of all reporting groups
285366|NCT00936455|B2|Baseline|Telephone|Telephone evaluated patients
285367|NCT00936455|B1|Baseline|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
285368|NCT00936455|P2|Participant Flow|Telephone|Telephone evaluated patients
285370|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 12 months after index event in telephone group
285373|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)
285374|NCT00936455|O2|Outcome|Telephone|Recurrent stroke at 6 months in each group
285375|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)
285376|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
285377|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group
285378|NCT00936455|E2|Reported Event|Telephone|Telephone evaluated patients
285379|NCT00936455|E1|Reported Event|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
285380|NCT00936377|B4|Baseline|Total|Total of all reporting groups
285381|NCT00936377|B3|Baseline|Placebo|"Normal saline~Placebo: Normal saline for five days."
285382|NCT00936377|B2|Baseline|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285383|NCT00936377|B1|Baseline|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285384|NCT00936377|P3|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline for five days."
285385|NCT00936377|P2|Participant Flow|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285386|NCT00936377|P1|Participant Flow|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285387|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285388|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285389|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285390|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285391|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285392|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285393|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285394|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285395|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285396|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285397|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285398|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285399|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285400|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285401|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285402|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285403|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285404|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285405|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285406|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285407|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285408|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
285442|NCT00936208|B3|Baseline|Total|Total of all reporting groups
285443|NCT00936208|B2|Baseline|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285409|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285410|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285411|NCT00936377|E3|Reported Event|Placebo|"Normal saline~Placebo: Normal saline for five days."
285412|NCT00936377|E2|Reported Event|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285413|NCT00936377|E1|Reported Event|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
285414|NCT00936351|B3|Baseline|Total|Total of all reporting groups
285415|NCT00936351|B2|Baseline|Arm 2|"Support Group~Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion."
285416|NCT00936351|B1|Baseline|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment."
285417|NCT00936351|P2|Participant Flow|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
285418|NCT00936351|P1|Participant Flow|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
285419|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
285420|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
285421|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
285422|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
285423|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
285424|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
285425|NCT00936351|E2|Reported Event|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
285426|NCT00936351|E1|Reported Event|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
285427|NCT00936221|B3|Baseline|Total|Total of all reporting groups
285428|NCT00936221|B2|Baseline|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
285429|NCT00936221|B1|Baseline|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
285430|NCT00936221|P2|Participant Flow|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
285431|NCT00936221|P1|Participant Flow|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
285432|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
285433|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
285434|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
285435|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
285436|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
285437|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
285438|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
285439|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
285445|NCT00936208|P2|Participant Flow|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285446|NCT00936208|P1|Participant Flow|Micardis 80mg|One tablet of Micardis 80mg per day
285447|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285448|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285449|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285450|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285451|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285452|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285453|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285454|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285455|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285456|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285457|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285458|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285459|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285460|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
285461|NCT00936208|E2|Reported Event|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
285462|NCT00936208|E1|Reported Event|Micardis 80mg|One tablet of Micardis 80mg per day
285463|NCT00936117|B1|Baseline|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
285464|NCT00936117|P1|Participant Flow|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
285465|NCT00936117|O2|Outcome|Posaconazole (Males)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
285466|NCT00936117|O1|Outcome|Posaconazole (Females)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
285467|NCT00936117|E1|Reported Event|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
285468|NCT00936065|B4|Baseline|Total|Total of all reporting groups
285469|NCT00936065|B3|Baseline|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285470|NCT00936065|B2|Baseline|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285471|NCT00936065|B1|Baseline|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285472|NCT00936065|P3|Participant Flow|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285473|NCT00936065|P2|Participant Flow|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285474|NCT00936065|P1|Participant Flow|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285475|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285476|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285477|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285478|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285479|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285480|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285481|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285482|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285483|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285484|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285485|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285486|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285487|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285488|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285489|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285490|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285491|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285492|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285493|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285494|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285495|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285496|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285497|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285498|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
289958|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
285499|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285500|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285501|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285502|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285503|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285504|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285505|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285506|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285507|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285508|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285509|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285510|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285511|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285512|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285513|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285514|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285515|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285516|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285517|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285518|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285519|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285520|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285521|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285522|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285523|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285524|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285525|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285526|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285527|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285528|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285529|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285530|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285531|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285532|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285533|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285534|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285535|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285536|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285537|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285538|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285539|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285540|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285541|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285542|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285543|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285544|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285545|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285546|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285547|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285548|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285549|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285550|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285551|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285552|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285553|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285554|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285555|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285556|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285557|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285558|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285559|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285560|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285561|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285562|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285563|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285564|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285565|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285566|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285567|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285568|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285569|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285570|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285571|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285572|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285573|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285574|NCT00936065|E3|Reported Event|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
285575|NCT00936065|E2|Reported Event|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
285576|NCT00936065|E1|Reported Event|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
285577|NCT00935883|B3|Baseline|Total|Total of all reporting groups
285578|NCT00935883|B2|Baseline|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285579|NCT00935883|B1|Baseline|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285580|NCT00935883|P2|Participant Flow|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285581|NCT00935883|P1|Participant Flow|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285602|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
285582|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285583|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285584|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285585|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285586|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285587|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285588|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285589|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285590|NCT00935883|E2|Reported Event|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285591|NCT00935883|E1|Reported Event|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
285592|NCT00935857|B3|Baseline|Total|Total of all reporting groups
285593|NCT00935857|B2|Baseline|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
285594|NCT00935857|B1|Baseline|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
285595|NCT00935857|P2|Participant Flow|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
285596|NCT00935857|P1|Participant Flow|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
285597|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
285598|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
285599|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
285600|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
285601|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
285603|NCT00935857|E2|Reported Event|Single Balloon Colonoscopy|Patients who are randomized to received single balloon colonoscopy as initial treatment.
285604|NCT00935857|E1|Reported Event|Standard Colonoscopy|Patients who are randomized to received standard colonoscopy as initial treatment.
285605|NCT00935818|B3|Baseline|Total|Total of all reporting groups
285606|NCT00935818|B2|Baseline|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285607|NCT00935818|B1|Baseline|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285608|NCT00935818|P2|Participant Flow|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285609|NCT00935818|P1|Participant Flow|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285610|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285611|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285612|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285613|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285614|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285615|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285616|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285617|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285618|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285619|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285620|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285742|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285779|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
285621|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285622|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285623|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285624|NCT00935818|E2|Reported Event|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
285625|NCT00935818|E1|Reported Event|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
285626|NCT00935792|B4|Baseline|Total|Total of all reporting groups
285627|NCT00935792|B3|Baseline|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285628|NCT00935792|B2|Baseline|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285629|NCT00935792|B1|Baseline|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285630|NCT00935792|P3|Participant Flow|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285631|NCT00935792|P2|Participant Flow|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285632|NCT00935792|P1|Participant Flow|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285633|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285634|NCT00935792|O1|Outcome|All Evaluable Patients|Patients are only evaluable for duration of response when they have already been noted as a complete response or partial response.
285635|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285636|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285637|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285638|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285639|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285640|NCT00935792|O3|Outcome|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285641|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285642|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285643|NCT00935792|E3|Reported Event|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285644|NCT00935792|E2|Reported Event|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285645|NCT00935792|E1|Reported Event|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
285646|NCT00935766|B3|Baseline|Total|Total of all reporting groups
285647|NCT00935766|B2|Baseline|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285648|NCT00935766|B1|Baseline|Placebo|Placebo (Four 1-gram capsules daily)
285649|NCT00935766|P2|Participant Flow|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285650|NCT00935766|P1|Participant Flow|Placebo|Placebo (Four 1-gram capsules daily)
285651|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285652|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
285653|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285654|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
285655|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285656|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
285657|NCT00935766|E2|Reported Event|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
285658|NCT00935766|E1|Reported Event|Placebo|Placebo (Four 1-gram capsules daily)
285780|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
285659|NCT00935701|B1|Baseline|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
285660|NCT00935701|P1|Participant Flow|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
285661|NCT00935701|O1|Outcome|Primary Group|
285662|NCT00935701|O1|Outcome|Primary Group|
285663|NCT00935701|O1|Outcome|Primary Group|
285664|NCT00935701|O1|Outcome|Primary Group|Phase 1
285665|NCT00935701|E1|Reported Event|Primary Group|
285666|NCT00935649|B1|Baseline|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
285667|NCT00935649|P1|Participant Flow|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
285668|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
285669|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
285670|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
285671|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
285672|NCT00935649|E2|Reported Event|Untreated Great Toe|untreated control great toe
285673|NCT00935649|E1|Reported Event|Treated Great Toe|Laser treatment of great toe
285674|NCT00935584|B3|Baseline|Total|Total of all reporting groups
285675|NCT00935584|B2|Baseline|PACE Study Providers|23 providers participated in the study. However, final analysis was based on 126 clinic visits.
285676|NCT00935584|B1|Baseline|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285677|NCT00935584|P2|Participant Flow|PACE Study Providers|23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
285678|NCT00935584|P1|Participant Flow|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.~126 patients started the study and 77 completed the study."
285679|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285680|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285681|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285682|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285683|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285684|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285685|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285743|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285686|NCT00935584|E1|Reported Event|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
285687|NCT00935532|B3|Baseline|Total|Total of all reporting groups
285688|NCT00935532|B2|Baseline|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285689|NCT00935532|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285690|NCT00935532|P2|Participant Flow|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285691|NCT00935532|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285692|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285693|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285694|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285695|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285696|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285697|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285698|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285699|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285700|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285701|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285702|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285703|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285704|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285705|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285706|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285707|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285708|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285709|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285710|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285711|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285712|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285713|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285714|NCT00935532|E2|Reported Event|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
285715|NCT00935532|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
285716|NCT00935493|B4|Baseline|Total|Total of all reporting groups
285717|NCT00935493|B3|Baseline|Placebo po Qhs|Placebo: Placebo po qhs
285718|NCT00935493|B2|Baseline|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
285719|NCT00935493|B1|Baseline|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
285720|NCT00935493|P3|Participant Flow|Placebo po Qhs|Placebo: Placebo po qhs
285721|NCT00935493|P2|Participant Flow|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
285722|NCT00935493|P1|Participant Flow|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
285723|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
285724|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
285725|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
285726|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
285727|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
285728|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
285729|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
285730|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
285731|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
285732|NCT00935493|E3|Reported Event|Placebo|Placebo: Placebo
285733|NCT00935493|E2|Reported Event|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
285734|NCT00935493|E1|Reported Event|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
285735|NCT00935311|B4|Baseline|Total|Total of all reporting groups
285736|NCT00935311|B3|Baseline|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285737|NCT00935311|B2|Baseline|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285738|NCT00935311|B1|Baseline|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285739|NCT00935311|P3|Participant Flow|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285740|NCT00935311|P2|Participant Flow|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285741|NCT00935311|P1|Participant Flow|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285744|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285745|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285746|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285747|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285748|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285749|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285750|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285751|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285752|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285753|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285754|NCT00935311|E3|Reported Event|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285755|NCT00935311|E2|Reported Event|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
285756|NCT00935311|E1|Reported Event|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
285757|NCT00935272|B3|Baseline|Total|Total of all reporting groups
285758|NCT00935272|B2|Baseline|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
285759|NCT00935272|B1|Baseline|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
285760|NCT00935272|P2|Participant Flow|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
285761|NCT00935272|P1|Participant Flow|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
285762|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
285763|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
285764|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
285765|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
285766|NCT00935272|E3|Reported Event|Second Treatment|At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
285767|NCT00935272|E2|Reported Event|No Treatment|Safety included post treatment assessment, and assessments at each visit throughout the study.
285768|NCT00935272|E1|Reported Event|Treatment With Restylane|Safety included post treatment assessment, and assessments at each visit throughout the study.
285769|NCT00935259|B1|Baseline|All Participants|All enrolled participants
285770|NCT00935259|P2|Participant Flow|Placebo First, Then Simvastatin 40 mg|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
285771|NCT00935259|P1|Participant Flow|Simvastatin 40 mg, Then Placebo|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
285772|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
285773|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
285774|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
285775|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
285776|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
285777|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
285778|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
285781|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
285782|NCT00935259|E2|Reported Event|Placebo|Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2
285783|NCT00935259|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2
285784|NCT00935220|B1|Baseline|Linagliptin 5mg|Linagliptin 5mg once daily
285785|NCT00935220|P1|Participant Flow|Linagliptin 5mg|Linagliptin 5mg once daily
285786|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285787|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285788|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285789|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285790|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285791|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285792|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285793|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285794|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
285795|NCT00935220|E1|Reported Event|Linagliptin 5mg|Linagliptin 5mg once daily
285796|NCT00935064|B3|Baseline|Total|Total of all reporting groups
285797|NCT00935064|B2|Baseline|Placebo|Once daily, for 6 weeks
285798|NCT00935064|B1|Baseline|Aliskiren|300 mg, once daily, for 6 weeks
285799|NCT00935064|P2|Participant Flow|Placebo|Once daily, for 6 weeks
285800|NCT00935064|P1|Participant Flow|Aliskiren|300 mg, once daily, for 6 weeks
285801|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
285802|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
285803|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
285804|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
285805|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
285806|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
285807|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
285808|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
285809|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
285810|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
285811|NCT00935064|E2|Reported Event|Placebo|Once daily, for 6 weeks
285812|NCT00935064|E1|Reported Event|Aliskiren|300 mg, once daily, for 6 weeks
285813|NCT00934947|B3|Baseline|Total|Total of all reporting groups
285814|NCT00934947|B2|Baseline|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
285815|NCT00934947|B1|Baseline|Sugar Pill|Identical to active drug in sight, taste, and smell.
285816|NCT00934947|P2|Participant Flow|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
285817|NCT00934947|P1|Participant Flow|Sugar Pill|Identical to active drug in sight, taste, and smell.
285818|NCT00934947|O2|Outcome|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
285819|NCT00934947|O1|Outcome|Sugar Pill|Identical to active drug in sight, taste, and smell.
285820|NCT00934947|E2|Reported Event|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
285821|NCT00934947|E1|Reported Event|Sugar Pill|Identical to active drug in sight, taste, and smell.
285822|NCT00934921|B3|Baseline|Total|Total of all reporting groups
285823|NCT00934921|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
285824|NCT00934921|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
285825|NCT00934921|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
285826|NCT00934921|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
285827|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285828|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
285829|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285830|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
285831|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285832|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
285833|NCT00934843|B3|Baseline|Total|Total of all reporting groups
285834|NCT00934843|B2|Baseline|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
285835|NCT00934843|B1|Baseline|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
285836|NCT00934843|P2|Participant Flow|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
285837|NCT00934843|P1|Participant Flow|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
285838|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
285839|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
285840|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
285841|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
285842|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
285843|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
285844|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
285845|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
285846|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
285847|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
285848|NCT00934843|E2|Reported Event|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
285849|NCT00934843|E1|Reported Event|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
285850|NCT00934791|B3|Baseline|Total|Total of all reporting groups
285851|NCT00934791|B2|Baseline|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
285852|NCT00934791|B1|Baseline|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
285853|NCT00934791|P2|Participant Flow|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
285854|NCT00934791|P1|Participant Flow|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
285855|NCT00934791|O2|Outcome|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
285856|NCT00934791|O1|Outcome|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
285857|NCT00934791|E2|Reported Event|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
285858|NCT00934791|E1|Reported Event|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
285859|NCT00934648|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285860|NCT00934648|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285861|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285862|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285863|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285864|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285865|NCT00934648|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
285866|NCT00934635|B10|Baseline|Total|Total of all reporting groups
285867|NCT00934635|B9|Baseline|Control|PET Scan Control
285868|NCT00934635|B8|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285869|NCT00934635|B7|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285870|NCT00934635|B6|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
285871|NCT00934635|B5|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
285872|NCT00934635|B4|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
285873|NCT00934635|B3|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285874|NCT00934635|B2|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285875|NCT00934635|B1|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285877|NCT00934635|P8|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285878|NCT00934635|P7|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285879|NCT00934635|P6|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
285880|NCT00934635|P5|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
285881|NCT00934635|P4|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
285882|NCT00934635|P3|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285883|NCT00934635|P2|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285884|NCT00934635|P1|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285885|NCT00934635|O9|Outcome|Control|PET Scan Control
285886|NCT00934635|O8|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285887|NCT00934635|O7|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285888|NCT00934635|O6|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
285889|NCT00934635|O5|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
285890|NCT00934635|O4|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
285891|NCT00934635|O3|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285892|NCT00934635|O2|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285893|NCT00934635|O1|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285894|NCT00934635|E9|Reported Event|Control|PET Scan Control
285895|NCT00934635|E8|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285896|NCT00934635|E7|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
285897|NCT00934635|E6|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
285898|NCT00934635|E5|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
285899|NCT00934635|E4|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
285900|NCT00934635|E3|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285901|NCT00934635|E2|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285902|NCT00934635|E1|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
285903|NCT00934622|B1|Baseline|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
285904|NCT00934622|P1|Participant Flow|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
285905|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
285906|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
285907|NCT00934622|E1|Reported Event|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
285908|NCT00934596|B3|Baseline|Total|Total of all reporting groups
285909|NCT00934596|B2|Baseline|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before cannulation, CO2 was insufflated in the mediastinum at a flow rate of 10 litres/minute and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively re-filled with blood and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under transesophageal echocardiographic (TEE) monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to eject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285978|NCT00934180|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
285979|NCT00934180|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
286151|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
285910|NCT00934596|B1|Baseline|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. Hereafter the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart defibrillated. After a good cardiac contraction and normal central hemodynamics were established, the LV preload was gradually and successively increased. When no air emboli were observed in the left side of the heart by transesophageal echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285911|NCT00934596|P2|Participant Flow|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the carbon-dioxide(CO2) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285912|NCT00934596|P1|Participant Flow|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart by Trans-esophageal Echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285913|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285914|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285915|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285916|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285955|NCT00934544|E1|Reported Event|INC424/INCB018424|"The starting dose of ruxolitinib tablets was determined based on baseline platelet count as follows: Subjects with baseline platelet count > 200, 000/µL began dosing at 20 mg bid (four 5 mg tablets bid) or Subjects with baseline platelet count of 100,000/µL to 200,000/µL (inclusive) began dosing at 15 mg bid (three 5 mg tablets bid).~A standardized dosing paradigm was used to determine dose adjustments for safety and efficacy so that each subject was titrated to their most appropriate dose."
285956|NCT00934375|B3|Baseline|Total|Total of all reporting groups
285957|NCT00934375|B2|Baseline|Placebo|
285917|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285918|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285919|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
285920|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285921|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285922|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285923|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285958|NCT00934375|B1|Baseline|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
285959|NCT00934375|P2|Participant Flow|Placebo|
285960|NCT00934375|P1|Participant Flow|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
285961|NCT00934375|O2|Outcome|Placebo|
285962|NCT00934375|O1|Outcome|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
285963|NCT00934375|E2|Reported Event|Placebo|
285964|NCT00934375|E1|Reported Event|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
285924|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285925|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285926|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285927|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285928|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285929|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
285930|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285965|NCT00934362|B3|Baseline|Total|Total of all reporting groups
285966|NCT00934362|B2|Baseline|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
285967|NCT00934362|B1|Baseline|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
285968|NCT00934362|P2|Participant Flow|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
285969|NCT00934362|P1|Participant Flow|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
285970|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
285971|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
285931|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285932|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285933|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285934|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285935|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
285936|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285937|NCT00934596|E2|Reported Event|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
285972|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
285973|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
285974|NCT00934362|E2|Reported Event|Placebo|0.9% NaCl x 6 ml (5 doses)
285975|NCT00934362|E1|Reported Event|Lucinactant|20 mg/ml x 6 ml (5 doses)
285976|NCT00934180|B3|Baseline|Total|Total of all reporting groups
285977|NCT00934180|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
286022|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
285938|NCT00934596|E1|Reported Event|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
285939|NCT00934544|B3|Baseline|Total|Total of all reporting groups
285940|NCT00934544|B2|Baseline|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285941|NCT00934544|B1|Baseline|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285942|NCT00934544|P2|Participant Flow|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285943|NCT00934544|P1|Participant Flow|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285944|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, or no therapy, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) was used.
285945|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg twice daily (BID) or 20 mg BID were selected with starting dose based on baseline platelet count. Starting dose was either 15 mg BID or 20 mg BID based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285946|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285947|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285948|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285949|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285950|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285951|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285952|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
285953|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
285954|NCT00934544|E2|Reported Event|Best Available Therapy (BAT)|Best Available Therapy (BAT) was prescribed at doses and schedules selected by the Investigator on a subject-by-subject basis. BAT could include a single agent, combination of agents for the treatment of the disease and its symptoms or no therapy. Therapy could be changed at any time during the study EXCEPT during the screening period. No experimental drugs were permitted during the study.
286023|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
285980|NCT00934180|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
285981|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285982|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
285983|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285984|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
285985|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
285986|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
285987|NCT00934141|B5|Baseline|Total|Total of all reporting groups
285988|NCT00934141|B4|Baseline|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
285989|NCT00934141|B3|Baseline|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
285990|NCT00934141|B2|Baseline|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
285991|NCT00934141|B1|Baseline|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
285992|NCT00934141|P4|Participant Flow|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
285993|NCT00934141|P3|Participant Flow|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
285994|NCT00934141|P2|Participant Flow|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
285995|NCT00934141|P1|Participant Flow|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
285996|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
285997|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
285998|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
285999|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
286000|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
286001|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
286024|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
286025|NCT00934128|E2|Reported Event|Group 2: Vapotherm Then BiPAP|Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
286002|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
286003|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
286004|NCT00934141|O4|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
286005|NCT00934141|O3|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
286006|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
286007|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
286008|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
286009|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
286010|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
286011|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
286012|NCT00934141|E4|Reported Event|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
286013|NCT00934141|E3|Reported Event|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
286014|NCT00934141|E2|Reported Event|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
286015|NCT00934141|E1|Reported Event|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
286016|NCT00934128|B3|Baseline|Total|Total of all reporting groups
286017|NCT00934128|B2|Baseline|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
286018|NCT00934128|B1|Baseline|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
286019|NCT00934128|P2|Participant Flow|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
286020|NCT00934128|P1|Participant Flow|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.
286021|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
286026|NCT00934128|E1|Reported Event|Group1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.
286027|NCT00934102|B1|Baseline|Overall|This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
286028|NCT00934102|P3|Participant Flow|Lotrafilcon A / Galyfilcon A|Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
286029|NCT00934102|P2|Participant Flow|Narafilcon A / Galyfilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
286030|NCT00934102|P1|Participant Flow|Narafilcon A / Lotrafilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
286031|NCT00934102|O3|Outcome|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286032|NCT00934102|O2|Outcome|Narafilcon A|Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286033|NCT00934102|O1|Outcome|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286034|NCT00934102|E3|Reported Event|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286035|NCT00934102|E2|Reported Event|Narafilcon A|Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286036|NCT00934102|E1|Reported Event|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
286037|NCT00934050|B7|Baseline|Total|Total of all reporting groups
286038|NCT00934050|B6|Baseline|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286039|NCT00934050|B5|Baseline|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286040|NCT00934050|B4|Baseline|2000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286041|NCT00934050|B3|Baseline|1000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286042|NCT00934050|B2|Baseline|250mg BID/2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286043|NCT00934050|B1|Baseline|Placebo/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286044|NCT00934050|P6|Participant Flow|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286045|NCT00934050|P5|Participant Flow|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286046|NCT00934050|P4|Participant Flow|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286047|NCT00934050|P3|Participant Flow|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286048|NCT00934050|P2|Participant Flow|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286049|NCT00934050|P1|Participant Flow|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286050|NCT00934050|O2|Outcome|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286051|NCT00934050|O1|Outcome|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286052|NCT00934050|E6|Reported Event|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286053|NCT00934050|E5|Reported Event|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
286054|NCT00934050|E4|Reported Event|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286055|NCT00934050|E3|Reported Event|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286056|NCT00934050|E2|Reported Event|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286057|NCT00934050|E1|Reported Event|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
286058|NCT00933933|B6|Baseline|Total|Total of all reporting groups
286059|NCT00933933|B5|Baseline|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
286060|NCT00933933|B4|Baseline|Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
286061|NCT00933933|B3|Baseline|Architect Ag/Ab Combo HIV-1 Antibody Sensitivity|Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
286062|NCT00933933|B2|Baseline|Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
286063|NCT00933933|B1|Baseline|Architect HIV Ag/Ab Combo Specificity|Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
286064|NCT00933933|P3|Participant Flow|Architect HIV Ag/Ab Combo Reactivity|"Reactivty populations included:~1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.~203 specimen from pregnant females at risk for HIV infection.~Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
286065|NCT00933933|P2|Participant Flow|Architect HIV Ag/Ab Combo Sensitivity|"Sensitivity populations included:~1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.~67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.~64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test."
286066|NCT00933933|P1|Participant Flow|Architect HIV Ag/Ab Combo Specificity|"Specificity populations included:~6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.~448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.~588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
286067|NCT00933933|O3|Outcome|Reactivity in Pregnant Female Population|Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.
286068|NCT00933933|O2|Outcome|Increased Risk for HIV From HIV-2 Endemic Area|Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test.
286069|NCT00933933|O1|Outcome|Increased Risk for HIV in US Population|Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.
286070|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population|Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.
286071|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pediatric Population|Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.
286072|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females|HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.
286147|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286073|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pregnant Females|HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.
286074|NCT00933933|O3|Outcome|HIV-2 Antibody Sensitivity|Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
286075|NCT00933933|O2|Outcome|HIV-1 Antibody Sensitivity|Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
286076|NCT00933933|O1|Outcome|HIV p24 Antgen Sensitivity|HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.
286077|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection|Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
286078|NCT00933933|E3|Reported Event|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
286079|NCT00933933|E2|Reported Event|Architect HIV Ag/Ab Combo Sensitivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
286080|NCT00933933|E1|Reported Event|Architect HIV Ag/Ab Combo Specificity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
286081|NCT00933686|B3|Baseline|Total|Total of all reporting groups
286082|NCT00933686|B2|Baseline|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286083|NCT00933686|B1|Baseline|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286084|NCT00933686|P2|Participant Flow|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286085|NCT00933686|P1|Participant Flow|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286086|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286087|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286088|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286089|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286090|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286091|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286092|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286093|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286094|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286095|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286148|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286149|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286150|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286096|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286097|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286098|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286099|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286100|NCT00933686|E2|Reported Event|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
286101|NCT00933686|E1|Reported Event|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
286102|NCT00933608|B3|Baseline|Total|Total of all reporting groups
286103|NCT00933608|B2|Baseline|Placebo|
286104|NCT00933608|B1|Baseline|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
286105|NCT00933608|P2|Participant Flow|Placebo|participants were taking 1 tablet twice a day to match memantine arm
286106|NCT00933608|P1|Participant Flow|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
286107|NCT00933608|O2|Outcome|Placebo|participant will be taking 1 tablet twice a day to match active arm
286108|NCT00933608|O1|Outcome|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
286109|NCT00933608|E2|Reported Event|Placebo|
286110|NCT00933608|E1|Reported Event|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
286111|NCT00933543|B3|Baseline|Total|Total of all reporting groups
286112|NCT00933543|B2|Baseline|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286113|NCT00933543|B1|Baseline|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286114|NCT00933543|P2|Participant Flow|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286115|NCT00933543|P1|Participant Flow|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286116|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286117|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286118|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286119|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286120|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286121|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286122|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286123|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286124|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286125|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286126|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286127|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286128|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286129|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286130|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286131|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286132|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286133|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286134|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286135|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286136|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286137|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286138|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286139|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286140|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286141|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286142|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286143|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286144|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286145|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286146|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286152|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286153|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286154|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286155|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286156|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286157|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286158|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286159|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286160|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286161|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286162|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286163|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286164|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286165|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286166|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286167|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286168|NCT00933543|E2|Reported Event|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
286169|NCT00933543|E1|Reported Event|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
286170|NCT00933491|B3|Baseline|Total|Total of all reporting groups
286171|NCT00933491|B2|Baseline|Control|Non-diabetics
286172|NCT00933491|B1|Baseline|Diabetic|Type II Diabetes
286173|NCT00933491|P2|Participant Flow|Control|Non-diabetics
286174|NCT00933491|P1|Participant Flow|Diabetic|Type II Diabetes
286175|NCT00933491|O2|Outcome|Control|Non-diabetics
286176|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
286177|NCT00933491|O2|Outcome|Control|Non-diabetics
286178|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
286179|NCT00933491|E2|Reported Event|Control|Non-diabetics
286180|NCT00933491|E1|Reported Event|Diabetic|Type II Diabetes
286181|NCT00933335|B3|Baseline|Total|Total of all reporting groups
286182|NCT00933335|B2|Baseline|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286183|NCT00933335|B1|Baseline|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
286184|NCT00933335|P2|Participant Flow|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286185|NCT00933335|P1|Participant Flow|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
286186|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286187|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286679|NCT00932165|B1|Baseline|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286188|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286189|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286190|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286191|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286192|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286193|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286194|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286195|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286232|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286196|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286197|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286198|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286199|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286200|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286201|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286202|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286203|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286204|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286205|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286206|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286207|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286208|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286209|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286210|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286211|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286212|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286213|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286214|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286255|NCT00933270|P1|Participant Flow|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286256|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286215|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286216|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286217|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286218|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286219|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286220|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286221|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286222|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286580|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286223|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286224|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286225|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286226|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286227|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286228|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286229|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286230|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286231|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286233|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286234|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286235|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286236|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286237|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286238|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286239|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286240|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286241|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286242|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286257|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286581|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
289959|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
286243|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286244|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286245|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286246|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286247|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286248|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286249|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286250|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
286251|NCT00933335|E3|Reported Event|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
286252|NCT00933335|E2|Reported Event|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
286253|NCT00933335|E1|Reported Event|Fludarabine|Participants who received any number of cycles of IV fludarabine monophosphate (25 mg/m^2/day). Each cycle was administered for 5 days every 5 to 6 weeks.
286254|NCT00933270|B1|Baseline|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286258|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286259|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286260|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286261|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286262|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286263|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286264|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286265|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286266|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286267|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286268|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286269|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286270|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286271|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286272|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286273|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286274|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286275|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286276|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286277|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286278|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286279|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286280|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286281|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286282|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286582|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286283|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286284|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286285|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286286|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286287|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286288|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286289|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286290|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286291|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286292|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286293|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286294|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286295|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286296|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286297|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286298|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286299|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286300|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286301|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286302|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286303|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286304|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286305|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286306|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286307|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286583|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286308|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286309|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286310|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286311|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286312|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286313|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286314|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286315|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286316|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286317|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286318|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286319|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286320|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286321|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286322|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286323|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286324|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286325|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286326|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286327|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286328|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286329|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286330|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286331|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286332|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286584|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286333|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286334|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286335|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286336|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286337|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286338|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286339|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286340|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286341|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286342|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
286343|NCT00933270|E2|Reported Event|Supera® Peripheral Stent System Roll-in|"Implantation of Supera stent using the Supera® Peripheral Stent System.~There were a total of 61 roll-in subjects."
286344|NCT00933270|E1|Reported Event|Supera® Peripheral Stent System ITT|"Implantation of Supera stent using the Supera® Peripheral Stent System.~ITT population consisted of 264 subjects."
286345|NCT00933244|B4|Baseline|Total|Total of all reporting groups
286346|NCT00933244|B3|Baseline|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286347|NCT00933244|B2|Baseline|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286348|NCT00933244|B1|Baseline|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286349|NCT00933244|P3|Participant Flow|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286350|NCT00933244|P2|Participant Flow|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286351|NCT00933244|P1|Participant Flow|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286352|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286392|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286353|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286354|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286355|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286356|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286357|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286358|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286359|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286360|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286361|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286362|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286363|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286364|NCT00933244|E3|Reported Event|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286365|NCT00933244|E2|Reported Event|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
286393|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
289960|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
286366|NCT00933244|E1|Reported Event|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
286367|NCT00933166|B1|Baseline|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
286368|NCT00933166|P1|Participant Flow|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
286369|NCT00933166|O1|Outcome|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
286370|NCT00933166|E1|Reported Event|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
286371|NCT00932893|B3|Baseline|Total|Total of all reporting groups
286372|NCT00932893|B2|Baseline|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286373|NCT00932893|B1|Baseline|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286374|NCT00932893|P2|Participant Flow|Chemotherapy|Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286375|NCT00932893|P1|Participant Flow|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286376|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286377|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286378|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286379|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286380|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286381|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286382|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286383|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286384|NCT00932893|O1|Outcome|Overall Values|Overall assessment for complete response, partial response, stable disease, progressive disease and early death
286385|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286386|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286387|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286388|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286389|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286390|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286391|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286585|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286394|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286395|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286396|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286397|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286398|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286399|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286400|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286401|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286402|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286403|NCT00932893|E2|Reported Event|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286404|NCT00932893|E1|Reported Event|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
286405|NCT00932659|B1|Baseline|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
286406|NCT00932659|P1|Participant Flow|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
286407|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
286408|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
286409|NCT00932659|E1|Reported Event|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
286410|NCT00932646|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
286411|NCT00932646|P4|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286412|NCT00932646|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286413|NCT00932646|P2|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286586|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
289961|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
286414|NCT00932646|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286415|NCT00932646|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286416|NCT00932646|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286417|NCT00932646|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286418|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286419|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286420|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286421|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286422|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
286423|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286424|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286425|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286426|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286427|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286428|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286429|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286430|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286431|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286432|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286433|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286434|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286435|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286436|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286437|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286438|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286439|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286440|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286441|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286442|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286443|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286444|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286445|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286446|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286447|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286448|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286449|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286450|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286451|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286452|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286453|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286454|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286455|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286456|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286457|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286458|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286459|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286460|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286461|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286462|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
286463|NCT00932646|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286464|NCT00932646|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286465|NCT00932646|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286466|NCT00932646|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286467|NCT00932620|B3|Baseline|Total|Total of all reporting groups
286501|NCT00932451|P1|Participant Flow|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286468|NCT00932620|B2|Baseline|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
286469|NCT00932620|B1|Baseline|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
286470|NCT00932620|P2|Participant Flow|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
286471|NCT00932620|P1|Participant Flow|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
286472|NCT00932620|O2|Outcome|Simvastatin/Ezetimibe 10/10|
286473|NCT00932620|O1|Outcome|Simvastatin 40|
286474|NCT00932620|O2|Outcome|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
286475|NCT00932620|O1|Outcome|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
286476|NCT00932620|E2|Reported Event|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
286477|NCT00932620|E1|Reported Event|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
286478|NCT00932477|B1|Baseline|All Study Participants|All Study Participants
286479|NCT00932477|P6|Participant Flow|Sequence CBA|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
286480|NCT00932477|P5|Participant Flow|Sequence CAB|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
286481|NCT00932477|P4|Participant Flow|Sequence BCA|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
286482|NCT00932477|P3|Participant Flow|Sequence BAC|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
286483|NCT00932477|P2|Participant Flow|Sequence ACB|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
286484|NCT00932477|P1|Participant Flow|Sequence ABC|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
286485|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
286486|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286487|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286488|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
286489|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286490|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286491|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
286492|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286493|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286494|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
286495|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286496|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
286497|NCT00932477|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
286498|NCT00932477|E2|Reported Event|Artificial Tear Formulation 2|Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
286499|NCT00932477|E1|Reported Event|Artificial Tear Formulation 1|Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
286500|NCT00932451|B1|Baseline|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286579|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
289962|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
286502|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286503|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286504|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286505|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286506|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286507|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286508|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286509|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286510|NCT00932451|O2|Outcome|Crizotinib 250 mg BID-ALT Controls|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286511|NCT00932451|O1|Outcome|Crizotinib 250 mg BID-ALT Cases|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286512|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286513|NCT00932451|O2|Outcome|PF-06260182|PF-06260182 was a PF-02341066 metabolite measured in this study.
286514|NCT00932451|O1|Outcome|Crizotinib (PF-02341066)|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286515|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286516|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286517|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286518|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286519|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286520|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286521|NCT00932451|E1|Reported Event|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
286522|NCT00932425|B3|Baseline|Total|Total of all reporting groups
286523|NCT00932425|B2|Baseline|Control|Patients discharged home with standard clinical follow-up
286524|NCT00932425|B1|Baseline|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286525|NCT00932425|P2|Participant Flow|Control|Patients discharged home with standard clinical follow-up
286526|NCT00932425|P1|Participant Flow|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286527|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286528|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
286529|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286530|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
286531|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286532|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
286533|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286534|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
286535|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286536|NCT00932425|E2|Reported Event|Control|Patients discharged home with standard clinical follow-up
286537|NCT00932425|E1|Reported Event|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
286538|NCT00932399|B3|Baseline|Total|Total of all reporting groups
286539|NCT00932399|B2|Baseline|Group 2|No history of lower limb amputation
286540|NCT00932399|B1|Baseline|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
286541|NCT00932399|P2|Participant Flow|Group 2|No history of lower limb amputation
286542|NCT00932399|P1|Participant Flow|Group 1|Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
286543|NCT00932399|O2|Outcome|Group 2|No history of lower limb amputation
286544|NCT00932399|O1|Outcome|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
286545|NCT00932399|E2|Reported Event|Group 2|No history of lower limb amputation
286546|NCT00932399|E1|Reported Event|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
286547|NCT00932373|B12|Baseline|Total|Total of all reporting groups
286548|NCT00932373|B11|Baseline|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286549|NCT00932373|B10|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286550|NCT00932373|B9|Baseline|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286551|NCT00932373|B8|Baseline|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286552|NCT00932373|B7|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286553|NCT00932373|B6|Baseline|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286554|NCT00932373|B5|Baseline|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286555|NCT00932373|B4|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286556|NCT00932373|B3|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286557|NCT00932373|B2|Baseline|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286558|NCT00932373|B1|Baseline|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286559|NCT00932373|P11|Participant Flow|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286560|NCT00932373|P10|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286561|NCT00932373|P9|Participant Flow|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286562|NCT00932373|P8|Participant Flow|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286563|NCT00932373|P7|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286564|NCT00932373|P6|Participant Flow|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286565|NCT00932373|P5|Participant Flow|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286566|NCT00932373|P4|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286567|NCT00932373|P3|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286568|NCT00932373|P2|Participant Flow|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286569|NCT00932373|P1|Participant Flow|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286570|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286571|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286572|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286573|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286574|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286575|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286576|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286577|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286578|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286587|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286588|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286589|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286590|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286591|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286592|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286593|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286594|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286595|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286596|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286597|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286598|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286599|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286600|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286601|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286602|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286603|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
286604|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286605|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286606|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286607|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286608|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286609|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286610|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286611|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286612|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286613|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286614|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286615|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286616|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
286617|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286618|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286619|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286620|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286621|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286622|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286623|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286624|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286625|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286626|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286627|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286628|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286629|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286630|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286631|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286632|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286633|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286634|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286635|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286636|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286637|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286638|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286639|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286640|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286641|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286642|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286643|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286644|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286645|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286646|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
286647|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
286648|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
286649|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
286650|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
286651|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286652|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286653|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286654|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286655|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286656|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286657|NCT00932373|E11|Reported Event|Trastuzumab-MCC-DM 2.9 mg/kg Weekly|2.9 mg/kg administered intravenously (IV) once a week
286658|NCT00932373|E10|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Weekly|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
286659|NCT00932373|E9|Reported Event|Trastuzumab-MCC-DM 2.0 mg/kg Weekly|Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
286660|NCT00932373|E8|Reported Event|Trastuzumab-MCC-DM 1.6 mg/kg Weekly|Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
286661|NCT00932373|E7|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Weekly|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
286662|NCT00932373|E6|Reported Event|Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
286663|NCT00932373|E5|Reported Event|Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
286664|NCT00932373|E4|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
286665|NCT00932373|E3|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
286666|NCT00932373|E2|Reported Event|Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
286667|NCT00932373|E1|Reported Event|Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
286668|NCT00932321|B3|Baseline|Total|Total of all reporting groups
286669|NCT00932321|B2|Baseline|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
286670|NCT00932321|B1|Baseline|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
286671|NCT00932321|P2|Participant Flow|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
286672|NCT00932321|P1|Participant Flow|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
286673|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
286674|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
286675|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
286676|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
286677|NCT00932321|E2|Reported Event|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
286678|NCT00932321|E1|Reported Event|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
289963|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
286680|NCT00932165|P1|Participant Flow|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286681|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286682|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286683|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286684|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286685|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
286686|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286687|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
286688|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286689|NCT00932165|E1|Reported Event|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
286690|NCT00932152|B3|Baseline|Total|Total of all reporting groups
286691|NCT00932152|B2|Baseline|Fulvestrant, Anastrozole and Bevacizumab|
286692|NCT00932152|B1|Baseline|Fulvestrant and Anastrozole Only|
286693|NCT00932152|P2|Participant Flow|Fulvestrant, Anastrozole and Bevacizumab|
286694|NCT00932152|P1|Participant Flow|Fulvestrant and Anastrozole Only|
286695|NCT00932152|O1|Outcome|All Participants (Overall Study)|
286696|NCT00932152|E1|Reported Event|All Participants (Overall Study)|
286697|NCT00932126|B1|Baseline|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID
286698|NCT00932126|P8|Participant Flow|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice dailly
286699|NCT00932126|P7|Participant Flow|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
286700|NCT00932126|P6|Participant Flow|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
286701|NCT00932126|P5|Participant Flow|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
286702|NCT00932126|P4|Participant Flow|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
286703|NCT00932126|P3|Participant Flow|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
286704|NCT00932126|P2|Participant Flow|PF-03758309, 1 mg Twice Daily (BID)|PF-03758309 1 mg administered orally twice daily
286705|NCT00932126|P1|Participant Flow|PF-03758309, 1 Milligram (mg) Once Daily (QD)|PF-03758309 1 mg administered orally once daily
286706|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286707|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286708|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286709|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286710|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286711|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286712|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286713|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286714|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286715|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
286716|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
286717|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
286718|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
286719|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
286720|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309, 10 mg BID PF-03758309 10 mg administered orally twice daily
286721|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
286722|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
286723|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
286724|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
286725|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
286726|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
286727|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
286728|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
286729|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
286730|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
286731|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
286732|NCT00932126|E8|Reported Event|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
286733|NCT00932126|E7|Reported Event|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
286734|NCT00932126|E6|Reported Event|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
286735|NCT00932126|E5|Reported Event|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
286736|NCT00932126|E4|Reported Event|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
286737|NCT00932126|E3|Reported Event|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
286738|NCT00932126|E2|Reported Event|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
286739|NCT00932126|E1|Reported Event|PF-03758309, 1 mg QD|PF-03758309, 1 mg administered orally once daily
286740|NCT00932022|B3|Baseline|Total|Total of all reporting groups
286741|NCT00932022|B2|Baseline|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286742|NCT00932022|B1|Baseline|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286743|NCT00932022|P2|Participant Flow|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286744|NCT00932022|P1|Participant Flow|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286745|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286746|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286747|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286748|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286749|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286750|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286751|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286752|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286753|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286754|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286755|NCT00932022|E2|Reported Event|Placebo|Placebo capsule taken orally once daily for 14 weeks.
286756|NCT00932022|E1|Reported Event|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
286757|NCT00931996|B1|Baseline|Antipsychotic|Antipsychotic treatment
286758|NCT00931996|P1|Participant Flow|Antipsychotic|Antipsychotic treatment
286759|NCT00931996|O1|Outcome|Antipsychotic|Antipsychotic treatment
286760|NCT00931996|E1|Reported Event|Antipsychotic|Antipsychotic treatment
286761|NCT00931918|B3|Baseline|Total|Total of all reporting groups
286762|NCT00931918|B2|Baseline|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286763|NCT00931918|B1|Baseline|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286764|NCT00931918|P2|Participant Flow|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286765|NCT00931918|P1|Participant Flow|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286766|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286767|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286768|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286769|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286770|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286771|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286772|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286773|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286774|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286775|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286776|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286777|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286778|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286779|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286780|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286781|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286782|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286783|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286784|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286834|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286835|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286785|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286786|NCT00931918|E2|Reported Event|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286787|NCT00931918|E1|Reported Event|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
286788|NCT00931801|B4|Baseline|Total|Total of all reporting groups
286789|NCT00931801|B3|Baseline|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286790|NCT00931801|B2|Baseline|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286791|NCT00931801|B1|Baseline|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286792|NCT00931801|P3|Participant Flow|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286793|NCT00931801|P2|Participant Flow|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286794|NCT00931801|P1|Participant Flow|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286795|NCT00931801|O4|Outcome|Total|All study arms combined
286796|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286797|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286798|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286799|NCT00931801|O4|Outcome|Total|All study arms combined
286800|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286801|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286802|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286803|NCT00931801|O4|Outcome|Total|All study arms combined
286804|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286805|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286806|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286807|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286808|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
286809|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
286810|NCT00931801|E4|Reported Event|Total|All study arms combined
286811|NCT00931801|E3|Reported Event|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
286812|NCT00931801|E2|Reported Event|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
286813|NCT00931801|E1|Reported Event|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
286814|NCT00931723|B3|Baseline|Total|Total of all reporting groups
286815|NCT00931723|B2|Baseline|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286816|NCT00931723|B1|Baseline|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286817|NCT00931723|P2|Participant Flow|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286818|NCT00931723|P1|Participant Flow|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286819|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286820|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286821|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286822|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286823|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286824|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286825|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286826|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286827|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286828|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286829|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286830|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286831|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286832|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286833|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286836|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286837|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286838|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286839|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286840|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286841|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286842|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286843|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286844|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286845|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286846|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286847|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286848|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286849|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286850|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286851|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286852|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286853|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286854|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286855|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286856|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286857|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286858|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286859|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286860|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286861|NCT00931723|E2|Reported Event|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
286862|NCT00931723|E1|Reported Event|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
286863|NCT00931710|B3|Baseline|Total|Total of all reporting groups
286864|NCT00931710|B2|Baseline|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286865|NCT00931710|B1|Baseline|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286866|NCT00931710|P2|Participant Flow|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286867|NCT00931710|P1|Participant Flow|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286868|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286869|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286870|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286871|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286872|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286906|NCT00931515|O1|Outcome|NuBac|The NUBAC® disc arthroplasty system.
286873|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286874|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286875|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286876|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286877|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286878|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
286879|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
286880|NCT00931710|E2|Reported Event|Losartan / HCTZ|Losartan / HCTZ
286881|NCT00931710|E1|Reported Event|Valsartan / Amlodipine / HCTZ|Valsartan / amlodipine / HCTZ
286882|NCT00931632|B3|Baseline|Total|Total of all reporting groups
286883|NCT00931632|B2|Baseline|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
286884|NCT00931632|B1|Baseline|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
286885|NCT00931632|P2|Participant Flow|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
286886|NCT00931632|P1|Participant Flow|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
286887|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
286888|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
286889|NCT00931632|E2|Reported Event|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
286890|NCT00931632|E1|Reported Event|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
286891|NCT00931528|B3|Baseline|Total|Total of all reporting groups
286892|NCT00931528|B2|Baseline|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
286893|NCT00931528|B1|Baseline|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
286894|NCT00931528|P2|Participant Flow|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
286895|NCT00931528|P1|Participant Flow|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
286896|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
286897|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
286898|NCT00931528|E2|Reported Event|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
286899|NCT00931528|E1|Reported Event|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
286900|NCT00931515|B3|Baseline|Total|Total of all reporting groups
286901|NCT00931515|B2|Baseline|ProDisc|The ProDisc® total disc replacement system.
286902|NCT00931515|B1|Baseline|NuBac|The NUBAC® disc arthroplasty system.
286903|NCT00931515|P2|Participant Flow|ProDisc|The ProDisc® total disc replacement system.
286904|NCT00931515|P1|Participant Flow|NuBac|The NUBAC® disc arthroplasty system.
286905|NCT00931515|O2|Outcome|ProDisc|The ProDisc® device total disc replacement system.
286907|NCT00931515|E2|Reported Event|ProDisc|The ProDisc® device total disc replacement system.
286908|NCT00931515|E1|Reported Event|NuBac|The NUBAC® disc arthroplasty system.
286909|NCT00931463|B3|Baseline|Total|Total of all reporting groups
286910|NCT00931463|B2|Baseline|Ritonavir-boosted Lopinavir and Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
286911|NCT00931463|B1|Baseline|Ritonavir-boosted Lopinavir and 2N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
286912|NCT00931463|P2|Participant Flow|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286913|NCT00931463|P1|Participant Flow|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286914|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286915|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286916|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286917|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286918|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286919|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286920|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286921|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286922|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286923|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286924|NCT00931463|E2|Reported Event|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
286925|NCT00931463|E1|Reported Event|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
286926|NCT00931411|B3|Baseline|Total|Total of all reporting groups
286927|NCT00931411|B2|Baseline|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
286928|NCT00931411|B1|Baseline|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
286929|NCT00931411|P2|Participant Flow|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
286930|NCT00931411|P1|Participant Flow|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
286931|NCT00931411|O1|Outcome|All Study Patients|
286932|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
286933|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
286934|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286935|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286936|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
286937|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
286969|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286938|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286939|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286940|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286941|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286942|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286943|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286944|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286945|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286946|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286947|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
286948|NCT00931411|E2|Reported Event|Formulation 609209|"Adverse events that were recorded before Day 42 for the group Formulation 609209 then 609580 20 and recorded in the subsequent 2 weeks for the group Formulation 609580 20 then 609209. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
286949|NCT00931411|E1|Reported Event|Formulation 609580 20|"Adverse events that were recorded before Day 42 for the group Formulation 609580 20 then 609209 and recorded in the subsequent 2 weeks for the group Formulation 609209 then 609580 20. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
286950|NCT00931385|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
286951|NCT00931385|P4|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286952|NCT00931385|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286953|NCT00931385|P2|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286954|NCT00931385|P1|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
286955|NCT00931385|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286956|NCT00931385|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286957|NCT00931385|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286958|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286959|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286960|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286961|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286962|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286963|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286964|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286965|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286966|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286967|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286968|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286970|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286971|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286972|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286973|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286974|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286975|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286976|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286977|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286978|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286979|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286980|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286981|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286982|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286983|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286984|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286985|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286986|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286987|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286988|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286989|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286990|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286991|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286992|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286993|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286994|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286995|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
286996|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
286997|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
286998|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
286999|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
287000|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
287001|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
287002|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
287003|NCT00931385|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
287004|NCT00931385|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
287005|NCT00931385|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
287006|NCT00931385|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
287007|NCT00931359|B3|Baseline|Total|Total of all reporting groups
287008|NCT00931359|B2|Baseline|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287009|NCT00931359|B1|Baseline|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287010|NCT00931359|P2|Participant Flow|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287011|NCT00931359|P1|Participant Flow|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287012|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287013|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287014|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287015|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287016|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287017|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287018|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287019|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287020|NCT00931359|E2|Reported Event|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
287021|NCT00931359|E1|Reported Event|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
287022|NCT00931307|B1|Baseline|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
287170|NCT00930774|E4|Reported Event|Standard-of-care|Standard-of-care informational counseling
287023|NCT00931307|P1|Participant Flow|Lotrafilcon A|Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
287024|NCT00931307|O1|Outcome|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
287025|NCT00931307|E1|Reported Event|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
287026|NCT00931268|B1|Baseline|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287027|NCT00931268|P1|Participant Flow|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287028|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287029|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287030|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287031|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287032|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287033|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287034|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287035|NCT00931268|E1|Reported Event|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
287036|NCT00931242|B3|Baseline|Total|Total of all reporting groups
287037|NCT00931242|B2|Baseline|Screen Failures|Subjects that were screened but failed to meet inclusion criteria for the study.
287038|NCT00931242|B1|Baseline|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
287039|NCT00931242|P2|Participant Flow|Screen Failures|Patients who were screened but failed to meet inclusion criteria for the study
287040|NCT00931242|P1|Participant Flow|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
287041|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
287042|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
287043|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
287044|NCT00931242|E1|Reported Event|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
287045|NCT00931164|B1|Baseline|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
287046|NCT00931164|P1|Participant Flow|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
287047|NCT00931164|O1|Outcome|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
287048|NCT00931164|E1|Reported Event|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
287049|NCT00930982|B3|Baseline|Total|Total of all reporting groups
287050|NCT00930982|B2|Baseline|Placebo|Inhalation of matching placebo twice a day
287051|NCT00930982|B1|Baseline|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287052|NCT00930982|P2|Participant Flow|Placebo|Inhalation of matching placebo twice a day
287053|NCT00930982|P1|Participant Flow|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287054|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287055|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287056|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287057|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287058|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287059|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287060|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287061|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287062|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287063|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287064|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287065|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287066|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287067|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287068|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287069|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287070|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287071|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287072|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287073|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287074|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287075|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287076|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287077|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287078|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287079|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287080|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287081|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287082|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
287083|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287084|NCT00930982|E2|Reported Event|Placebo|Inhalation of matching placebo twice a day
287085|NCT00930982|E1|Reported Event|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
287086|NCT00930969|B1|Baseline|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287087|NCT00930969|P1|Participant Flow|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287088|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287089|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287090|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287091|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287092|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287093|NCT00930969|E1|Reported Event|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
287094|NCT00930930|B3|Baseline|Total|Total of all reporting groups
287095|NCT00930930|B2|Baseline|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287096|NCT00930930|B1|Baseline|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287097|NCT00930930|P2|Participant Flow|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287098|NCT00930930|P1|Participant Flow|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287283|NCT00929734|B3|Baseline|Total|Total of all reporting groups
287099|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287100|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287101|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287102|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287103|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287104|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287105|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287106|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287107|NCT00930930|E2|Reported Event|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287108|NCT00930930|E1|Reported Event|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
287109|NCT00930813|B3|Baseline|Total|Total of all reporting groups
287110|NCT00930813|B2|Baseline|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
287111|NCT00930813|B1|Baseline|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
287112|NCT00930813|P2|Participant Flow|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
287113|NCT00930813|P1|Participant Flow|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
287114|NCT00930813|O2|Outcome|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
287115|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
287116|NCT00930813|O2|Outcome|Standard Uncoated PTA Catheter|Standard off-the-shelf uncoated PTA Catheter
287117|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel Coated Balloon Catheter
287118|NCT00930813|E2|Reported Event|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
287119|NCT00930813|E1|Reported Event|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
287120|NCT00930787|B3|Baseline|Total|Total of all reporting groups
287121|NCT00930787|B2|Baseline|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
287122|NCT00930787|B1|Baseline|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
287123|NCT00930787|P2|Participant Flow|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
287124|NCT00930787|P1|Participant Flow|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
287125|NCT00930787|O2|Outcome|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
287126|NCT00930787|O1|Outcome|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
287127|NCT00930787|E2|Reported Event|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
287128|NCT00930787|E1|Reported Event|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
287129|NCT00930774|B5|Baseline|Total|Total of all reporting groups
287130|NCT00930774|B4|Baseline|Standard-of-Care|Standard-of-care informational counseling
287131|NCT00930774|B3|Baseline|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287132|NCT00930774|B2|Baseline|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287133|NCT00930774|B1|Baseline|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287134|NCT00930774|P4|Participant Flow|Standard-of-Care|Standard-of-care informational counseling
287135|NCT00930774|P3|Participant Flow|FM System and Auditory Training|"Provision of frequency modulation (FM) assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287136|NCT00930774|P2|Participant Flow|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287137|NCT00930774|P1|Participant Flow|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287138|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287139|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287140|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287141|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287142|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287143|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287144|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287145|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287146|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287147|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287148|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287149|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287150|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287151|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287152|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287153|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287154|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287155|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287156|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287157|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287158|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287159|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287160|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287161|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287162|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287163|NCT00930774|O3|Outcome|FM Sytem + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287164|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287165|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287166|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
287167|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287168|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287169|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287171|NCT00930774|E3|Reported Event|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
287172|NCT00930774|E2|Reported Event|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
287173|NCT00930774|E1|Reported Event|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
287174|NCT00930761|B3|Baseline|Total|Total of all reporting groups
287175|NCT00930761|B2|Baseline|Music Therapy|
287176|NCT00930761|B1|Baseline|Control|
287177|NCT00930761|P2|Participant Flow|Music Therapy|
287178|NCT00930761|P1|Participant Flow|Control|
287179|NCT00930761|O2|Outcome|Music Therapy|
287180|NCT00930761|O1|Outcome|Control|
287181|NCT00930761|O2|Outcome|Music Therapy|
287182|NCT00930761|O1|Outcome|Control|
287183|NCT00930761|O2|Outcome|Music Therapy|
287184|NCT00930761|O1|Outcome|Control|
287185|NCT00930761|O2|Outcome|Music Therapy|
287186|NCT00930761|O1|Outcome|Control|
287187|NCT00930761|E2|Reported Event|Music Therapy|
287188|NCT00930761|E1|Reported Event|Control|
287189|NCT00930722|B1|Baseline|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287190|NCT00930722|P1|Participant Flow|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287191|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287192|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287193|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287194|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287195|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287196|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287197|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287198|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287199|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287200|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287201|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287202|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287203|NCT00930722|E1|Reported Event|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
287204|NCT00930644|B1|Baseline|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
287205|NCT00930644|P1|Participant Flow|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
287206|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287207|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287208|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287209|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287210|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287284|NCT00929734|B2|Baseline|Placebo|Placebo tablet
287285|NCT00929734|B1|Baseline|Rosuvastatin|Rosuvastatin 10mg tablet
287211|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287212|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287213|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287214|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287215|NCT00930644|E2|Reported Event|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287216|NCT00930644|E1|Reported Event|NT,PBO/TED|No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
287217|NCT00930293|B3|Baseline|Total|Total of all reporting groups
287218|NCT00930293|B2|Baseline|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287219|NCT00930293|B1|Baseline|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287220|NCT00930293|P2|Participant Flow|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287221|NCT00930293|P1|Participant Flow|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287222|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287223|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287224|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287225|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287226|NCT00930293|E2|Reported Event|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287227|NCT00930293|E1|Reported Event|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
287228|NCT00930176|B1|Baseline|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
287229|NCT00930176|P1|Participant Flow|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
287230|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
287231|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
287232|NCT00930176|E1|Reported Event|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
287233|NCT00929981|B1|Baseline|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287234|NCT00929981|P1|Participant Flow|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287235|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287236|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287237|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287238|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287239|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287240|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287241|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287242|NCT00929981|E1|Reported Event|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
287243|NCT00929864|B3|Baseline|Total|Total of all reporting groups
287244|NCT00929864|B2|Baseline|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287245|NCT00929864|B1|Baseline|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287246|NCT00929864|P2|Participant Flow|40 mg Adalimumab SC Biweekly|Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287247|NCT00929864|P1|Participant Flow|125 mg Abatacept SC Weekly|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287248|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287249|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287250|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287251|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287252|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287253|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287286|NCT00929734|P2|Participant Flow|Placebo|Placebo: 1 tablet, once daily in three months
287287|NCT00929734|P1|Participant Flow|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287288|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
287289|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287254|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287255|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287256|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287257|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287258|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287259|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287260|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287261|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287262|NCT00929864|E2|Reported Event|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287263|NCT00929864|E1|Reported Event|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
287264|NCT00929773|B3|Baseline|Total|Total of all reporting groups
287265|NCT00929773|B2|Baseline|Placebo Laser|inactive light
287266|NCT00929773|B1|Baseline|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
287267|NCT00929773|P2|Participant Flow|Placebo Laser|inactive light
287268|NCT00929773|P1|Participant Flow|Erchonia PL2000 Laser|Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .
287269|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287270|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
287271|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287272|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
287273|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287274|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
287275|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287276|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
287277|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287278|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
287279|NCT00929773|O2|Outcome|Placebo Laser|inactive light
287280|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
287281|NCT00929773|E2|Reported Event|Placebo Laser|inactive light
287282|NCT00929773|E1|Reported Event|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
287290|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
287291|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287292|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
287293|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287294|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
287295|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287296|NCT00929734|E2|Reported Event|Placebo|Placebo: 1 tablet, once daily in three months
287297|NCT00929734|E1|Reported Event|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
287298|NCT00929708|B6|Baseline|Total|Total of all reporting groups
287299|NCT00929708|B5|Baseline|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287300|NCT00929708|B4|Baseline|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287301|NCT00929708|B3|Baseline|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287302|NCT00929708|B2|Baseline|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287303|NCT00929708|B1|Baseline|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287304|NCT00929708|P5|Participant Flow|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287305|NCT00929708|P4|Participant Flow|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287306|NCT00929708|P3|Participant Flow|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287307|NCT00929708|P2|Participant Flow|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287308|NCT00929708|P1|Participant Flow|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287309|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287310|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287311|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287312|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287313|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287314|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287315|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287316|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287317|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287318|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287319|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287320|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287321|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287322|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287323|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287324|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287325|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287326|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287327|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287328|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287329|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287330|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287331|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287332|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287333|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287334|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287335|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287336|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287337|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287338|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287339|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287340|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287341|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287342|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287343|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287344|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287702|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287345|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287346|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287347|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287348|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287349|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287350|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287351|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287352|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287353|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287354|NCT00929708|E5|Reported Event|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
287355|NCT00929708|E4|Reported Event|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
287356|NCT00929708|E3|Reported Event|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
287357|NCT00929708|E2|Reported Event|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
287358|NCT00929708|E1|Reported Event|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
287359|NCT00929695|B3|Baseline|Total|Total of all reporting groups
287360|NCT00929695|B2|Baseline|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287361|NCT00929695|B1|Baseline|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287362|NCT00929695|P2|Participant Flow|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287363|NCT00929695|P1|Participant Flow|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287364|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287365|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287366|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287367|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287368|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287369|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287370|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287371|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287372|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287373|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287374|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287375|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287376|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287437|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287703|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287377|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287378|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287379|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287380|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287381|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287382|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
287383|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287384|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287385|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
287386|NCT00929695|O4|Outcome|Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
287387|NCT00929695|O3|Outcome|Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
287388|NCT00929695|O2|Outcome|Grade IIa GVHD; 1.0 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
287389|NCT00929695|O1|Outcome|Grade IIa GVHD; 0.5 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
287390|NCT00929695|E2|Reported Event|Arm II (Standard-dose)|"Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
287391|NCT00929695|E1|Reported Event|Arm I (Low-dose)|"Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
287392|NCT00929643|B1|Baseline|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287393|NCT00929643|P1|Participant Flow|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287394|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287395|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287396|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287397|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287398|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287399|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287400|NCT00929643|E1|Reported Event|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
287401|NCT00929578|B1|Baseline|All Study Participants - Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
287402|NCT00929578|P1|Participant Flow|All Study Participants|The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
287403|NCT00929578|O3|Outcome|1 Week Post Dose|Participants with fluphenazine serum levels > 0.200ng/ml
287404|NCT00929578|O2|Outcome|2 Hours Post Dose|Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
287405|NCT00929578|O1|Outcome|Baseline|Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
287406|NCT00929578|O1|Outcome|All Study Participants|Participants who experienced at least one adverse event.
287407|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
287408|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
287409|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
287410|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
287411|NCT00929578|E1|Reported Event|All Study Participants|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
287412|NCT00929526|B3|Baseline|Total|Total of all reporting groups
287413|NCT00929526|B2|Baseline|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287414|NCT00929526|B1|Baseline|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287415|NCT00929526|P2|Participant Flow|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287416|NCT00929526|P1|Participant Flow|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287417|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287418|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287419|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287420|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287421|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287422|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287423|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287424|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287425|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287426|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287427|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287428|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287429|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287430|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287431|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287432|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287433|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287434|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287435|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287436|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287704|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287438|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287439|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287440|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287441|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287442|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287443|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287444|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287445|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287446|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287447|NCT00929526|E2|Reported Event|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
287448|NCT00929526|E1|Reported Event|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
287449|NCT00929474|B3|Baseline|Total|Total of all reporting groups
287450|NCT00929474|B2|Baseline|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
287451|NCT00929474|B1|Baseline|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
287452|NCT00929474|P2|Participant Flow|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
287453|NCT00929474|P1|Participant Flow|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
287454|NCT00929474|O2|Outcome|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
287455|NCT00929474|O1|Outcome|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
287456|NCT00929474|E2|Reported Event|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
287457|NCT00929474|E1|Reported Event|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
287458|NCT00929383|B1|Baseline|Patients Treated With a Wingspan Stent|Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287459|NCT00929383|P1|Participant Flow|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287460|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287461|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287462|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287705|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287463|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287464|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287465|NCT00929383|E1|Reported Event|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
287466|NCT00929357|B3|Baseline|Total|Total of all reporting groups
287467|NCT00929357|B2|Baseline|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287468|NCT00929357|B1|Baseline|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287469|NCT00929357|P2|Participant Flow|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287470|NCT00929357|P1|Participant Flow|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287471|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287472|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287473|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287474|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287475|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287476|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287477|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287478|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287479|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287480|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287481|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287482|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287483|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287484|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287485|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287486|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287487|NCT00929357|E2|Reported Event|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
287488|NCT00929357|E1|Reported Event|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
287489|NCT00929331|B3|Baseline|Total|Total of all reporting groups
287490|NCT00929331|B2|Baseline|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287491|NCT00929331|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287492|NCT00929331|P2|Participant Flow|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287493|NCT00929331|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287494|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287495|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287496|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287497|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287498|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287499|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287500|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287501|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287502|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287503|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287504|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287505|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287506|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287507|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287508|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287509|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287510|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287511|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287512|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287513|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287514|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287515|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287516|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287517|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287518|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287519|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287520|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287521|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287522|NCT00929331|E2|Reported Event|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287523|NCT00929331|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
287524|NCT00929305|B3|Baseline|Total|Total of all reporting groups
287525|NCT00929305|B2|Baseline|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
287526|NCT00929305|B1|Baseline|Placebo Laser|inactive laser light
287527|NCT00929305|P2|Participant Flow|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
287528|NCT00929305|P1|Participant Flow|Placebo Laser|inactive laser light
287529|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
287530|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
287531|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
287532|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
287533|NCT00929305|E2|Reported Event|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
287534|NCT00929305|E1|Reported Event|Placebo Laser|inactive laser light
287535|NCT00929240|B1|Baseline|Intial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
287536|NCT00929240|P3|Participant Flow|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287537|NCT00929240|P2|Participant Flow|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287538|NCT00929240|P1|Participant Flow|Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel|During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
287539|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
287540|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
287570|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
287571|NCT00929201|E2|Reported Event|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
287572|NCT00929201|E1|Reported Event|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
287573|NCT00929162|B3|Baseline|Total|Total of all reporting groups
287706|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287541|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287542|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287543|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287544|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287545|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287546|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287547|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287548|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287574|NCT00929162|B2|Baseline|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287575|NCT00929162|B1|Baseline|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287549|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287550|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287551|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287552|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287553|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287554|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287555|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287556|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287576|NCT00929162|P2|Participant Flow|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287577|NCT00929162|P1|Participant Flow|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287557|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287558|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287559|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287560|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287561|NCT00929240|E3|Reported Event|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
287562|NCT00929240|E2|Reported Event|Maintenance Phase:Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
287563|NCT00929240|E1|Reported Event|Initial Treatment Phase:Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
287564|NCT00929201|B1|Baseline|All Participants|All randomized participants
287565|NCT00929201|P2|Participant Flow|Sita/Met FDC Then Sita + Met|Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
287566|NCT00929201|P1|Participant Flow|Sita + Met Then Sita/Met FDC|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
287567|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
287568|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
287569|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
287699|NCT00928746|B1|Baseline|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
287578|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287579|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287580|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287581|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287582|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287583|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287584|NCT00929162|E2|Reported Event|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287585|NCT00929162|E1|Reported Event|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
287586|NCT00929110|B4|Baseline|Total|Total of all reporting groups
287587|NCT00929110|B3|Baseline|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287588|NCT00929110|B2|Baseline|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287589|NCT00929110|B1|Baseline|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287590|NCT00929110|P3|Participant Flow|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287591|NCT00929110|P2|Participant Flow|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287592|NCT00929110|P1|Participant Flow|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287593|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287594|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287595|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287596|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287597|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287598|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287599|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287600|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287700|NCT00928746|P1|Participant Flow|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
287701|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287601|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287602|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287603|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287604|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287605|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287606|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287607|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287608|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287609|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287610|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287611|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287612|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287613|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287614|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287615|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287616|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287617|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287618|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287869|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287619|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287620|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287621|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287622|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287623|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287624|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287625|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287626|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287627|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287628|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287629|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287630|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287631|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287632|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287633|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287634|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287635|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287636|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
289964|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
287637|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287638|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287639|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287640|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287641|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287642|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287643|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287644|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287645|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287646|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287647|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287648|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287649|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287650|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287651|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287652|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287653|NCT00929110|E3|Reported Event|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287654|NCT00929110|E2|Reported Event|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
289965|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
287655|NCT00929110|E1|Reported Event|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
287656|NCT00929071|B1|Baseline|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
287657|NCT00929071|P1|Participant Flow|All Study Participants|Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
287658|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine~collagen: Injectable collagen~Lidocaine: admix anesthetic"
287659|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic~collagen: Injectable collagen~topical anesthetic"
287660|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine right nasolabial fold~collagen: Injectable collagen~Lidocaine: admix anesthetic"
287661|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic left nasolabial fold~collagen: Injectable collagen~topical anesthetic"
287662|NCT00929071|E1|Reported Event|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
287663|NCT00928954|B1|Baseline|All Study Participants|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
287664|NCT00928954|P2|Participant Flow|Memantine First, Then Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
287665|NCT00928954|P1|Participant Flow|Gabapentin First and Then Memantine|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
287666|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
287667|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
287668|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
287669|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
287670|NCT00928954|E2|Reported Event|Memantine|Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
287671|NCT00928954|E1|Reported Event|Gabapentin|Increasing dose to 300 mg four times per day (total of 1200 mg/day)
287672|NCT00928889|B3|Baseline|Total|Total of all reporting groups
287673|NCT00928889|B2|Baseline|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287674|NCT00928889|B1|Baseline|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287675|NCT00928889|P2|Participant Flow|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287676|NCT00928889|P1|Participant Flow|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287677|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287678|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287679|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287680|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287681|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287682|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287683|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287684|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287685|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287686|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287687|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287688|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287689|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287690|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287691|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287692|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287693|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287694|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287695|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287696|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287697|NCT00928889|E2|Reported Event|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
287698|NCT00928889|E1|Reported Event|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
287707|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287708|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287709|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287710|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287711|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287712|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287713|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287714|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287715|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
287716|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg - Oral inhalation) - 180 Actuations group
287717|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
287718|NCT00928746|E1|Reported Event|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
287719|NCT00928720|B4|Baseline|Total|Total of all reporting groups
287720|NCT00928720|B3|Baseline|Usual Care Alone|No intervention; participants will received usual medical care for fibromyalgia
287721|NCT00928720|B2|Baseline|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
287722|NCT00928720|B1|Baseline|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
287723|NCT00928720|P3|Participant Flow|Usual Care Alone|No intervention; usual medical care for fibromyalgia
287724|NCT00928720|P2|Participant Flow|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
287725|NCT00928720|P1|Participant Flow|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
287726|NCT00928720|O3|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
287727|NCT00928720|O2|Outcome|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
287728|NCT00928720|O1|Outcome|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
287729|NCT00928720|E3|Reported Event|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
287730|NCT00928720|E2|Reported Event|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
287731|NCT00928720|E1|Reported Event|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
287732|NCT00928694|B1|Baseline|All Participants|
287733|NCT00928694|P2|Participant Flow|SUPRALIP™ First, Then TRICOR™|UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
287734|NCT00928694|P1|Participant Flow|TRICOR™ First, Then SUPRALIP™|U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet
287735|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
287736|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
287737|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
287738|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
287739|NCT00928694|E2|Reported Event|Supralip™|UK formulation (SUPRALIP™) 160 mg tablet
287740|NCT00928694|E1|Reported Event|Tricor™|U.S. formulation (TRICOR™) 160 mg tablet
287741|NCT00928668|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
287742|NCT00928668|P5|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg|Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
289966|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
287743|NCT00928668|P4|Participant Flow|Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
287744|NCT00928668|P3|Participant Flow|Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
287745|NCT00928668|P2|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
287746|NCT00928668|P1|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
287747|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287748|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287749|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287750|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287751|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287752|NCT00928668|O5|Outcome|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287753|NCT00928668|O4|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
287754|NCT00928668|O3|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
287755|NCT00928668|O2|Outcome|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
287756|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
287757|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287758|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287759|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287760|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287761|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287762|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287763|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287764|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287765|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287766|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287767|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287768|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287769|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287770|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287771|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287772|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287773|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287774|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287775|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287776|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287777|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287778|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
287779|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
287780|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
287781|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
287782|NCT00928668|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
287783|NCT00928668|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
287784|NCT00928668|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
287785|NCT00928668|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
287786|NCT00928668|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
287787|NCT00928642|B1|Baseline|Treatment|Open label, non-randomized, single treatment group.
287788|NCT00928642|P1|Participant Flow|Oral Imatinib Plus Gemcitabine|Open label, non-randomized, single treatment group.
287789|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
287790|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
287791|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
287792|NCT00928642|O1|Outcome|Oral Imatinib Plus IV Gemcitabine|Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.
287793|NCT00928642|O1|Outcome|Oral Imatinib Puls IV Gemcitabine|Open label, non-randomized, single treatment group.
287794|NCT00928642|O1|Outcome|Oral Imatinib Plus Gemcitabine|"Open label, non-randomized, single treatment group.~All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine."
287795|NCT00928642|E1|Reported Event|Treatment|Open label, non-randomized, single treatment group.
287796|NCT00928512|B6|Baseline|Total|Total of all reporting groups
287797|NCT00928512|B5|Baseline|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287798|NCT00928512|B4|Baseline|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287799|NCT00928512|B3|Baseline|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287800|NCT00928512|B2|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287801|NCT00928512|B1|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287802|NCT00928512|P5|Participant Flow|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287803|NCT00928512|P4|Participant Flow|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287804|NCT00928512|P3|Participant Flow|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287805|NCT00928512|P2|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287806|NCT00928512|P1|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287807|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287808|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287809|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287810|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287811|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287812|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287813|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287814|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287815|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287816|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287817|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287818|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287819|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287820|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287821|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287822|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287823|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287824|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287825|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287826|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287827|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287828|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287829|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287830|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287831|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287832|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287833|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287834|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287835|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287836|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287837|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287838|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287839|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287840|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287841|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287842|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287843|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287844|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287845|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287846|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287847|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287848|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287849|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287850|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287851|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287852|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287853|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287854|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287855|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287856|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287857|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287858|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287859|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287860|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287861|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287862|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287863|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287864|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287865|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287866|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287867|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287868|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287870|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287871|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287872|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287873|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287874|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287875|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287876|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287877|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287878|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287879|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287880|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287881|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287882|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287883|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287884|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287885|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287886|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287887|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287888|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287889|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287890|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287891|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287892|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
287893|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
287894|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
287895|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
287896|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
287897|NCT00928512|E9|Reported Event|AIN457 300mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 300mg
287898|NCT00928512|E8|Reported Event|AIN457 150mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 150mg
287899|NCT00928512|E7|Reported Event|AIN457 75mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 75mg
287900|NCT00928512|E6|Reported Event|AIN457 25mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 25mg
287901|NCT00928512|E5|Reported Event|Placebo|Up to Week 20 - Placebo
287902|NCT00928512|E4|Reported Event|AIN457 300mg|Up to Week 20 - AIN457 300mg
287903|NCT00928512|E3|Reported Event|AIN457 150mg|Up to Week 20 - AIN457 150mg
287904|NCT00928512|E2|Reported Event|AIN457 75mg|Up to Week 20 - AIN457 75mg
287905|NCT00928512|E1|Reported Event|AIN457 25mg|Up to Week 20 - AIN457 25mg
287906|NCT00928486|B1|Baseline|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287907|NCT00928486|P1|Participant Flow|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287908|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287909|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287910|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287911|NCT00928486|E1|Reported Event|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
287912|NCT00928434|B4|Baseline|Total|Total of all reporting groups
287923|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
289967|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
287913|NCT00928434|B3|Baseline|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer’s labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"
287914|NCT00928434|B2|Baseline|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287915|NCT00928434|B1|Baseline|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287916|NCT00928434|P3|Participant Flow|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287917|NCT00928434|P2|Participant Flow|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287918|NCT00928434|P1|Participant Flow|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287919|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287920|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287921|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287922|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
288031|NCT00928304|O1|Outcome|Down Syndrome PET-positive (Majority Read)|Down Syndrome subjects positive for cerebral beta-amyloid as determined by majority read
289968|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
287924|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287925|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287926|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287927|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287928|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287929|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287930|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287931|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287932|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287933|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287934|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
288023|NCT00928395|P1|Participant Flow|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
288032|NCT00928304|O2|Outcome|Healthy Volunteer Group|Healthy volunteers enrolled in the study
287935|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287936|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287937|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287938|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287939|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287940|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287941|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287942|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287943|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287944|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287945|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287946|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
288024|NCT00928395|O1|Outcome|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
288033|NCT00928304|O1|Outcome|Down Syndrome Group|Subjects with Down Syndrome enrolled in the study
287947|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287948|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287949|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287950|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287951|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287952|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287953|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287954|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287955|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287956|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287957|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287958|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
288025|NCT00928395|E1|Reported Event|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
288026|NCT00928304|B1|Baseline|Subjects Enrolled in Study|All Down Syndrome and healthy volunteer subjects
287959|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287960|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287961|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287962|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287963|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287964|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287965|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287966|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287967|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
287968|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287969|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287970|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
288027|NCT00928304|P2|Participant Flow|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
288028|NCT00928304|P1|Participant Flow|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
288029|NCT00928304|O3|Outcome|Healthy Volunteer Group|All healthy volunteers enrolled in the study
287971|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
287972|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287973|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287974|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287975|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
287976|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287977|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287978|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287979|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287980|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287981|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
288195|NCT00928083|E17|Reported Event|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
287982|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287983|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287984|NCT00928434|O2|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
287985|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287986|NCT00928434|E3|Reported Event|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
287987|NCT00928434|E2|Reported Event|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
287988|NCT00928434|E1|Reported Event|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
287989|NCT00928421|B1|Baseline|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
287990|NCT00928421|P1|Participant Flow|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
287991|NCT00928421|O1|Outcome|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
287992|NCT00928421|E1|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
287993|NCT00928408|B1|Baseline|Cinacalcet|
287994|NCT00928408|P1|Participant Flow|Cinacalcet|
287995|NCT00928408|O1|Outcome|Cinacalcet|
287996|NCT00928408|O1|Outcome|Cinacalcet|
287997|NCT00928408|O1|Outcome|Cinacalcet|
287998|NCT00928408|O1|Outcome|Cinacalcet|
287999|NCT00928408|O1|Outcome|Cinacalcet|
288000|NCT00928408|O1|Outcome|Cinacalcet|
288001|NCT00928408|O1|Outcome|Cinacalcet|
288002|NCT00928408|O1|Outcome|Cinacalcet|
288003|NCT00928408|O1|Outcome|Cinacalcet|
288004|NCT00928408|O1|Outcome|Cinacalcet|
288005|NCT00928408|O1|Outcome|Cinacalcet|
288006|NCT00928408|O1|Outcome|Cinacalcet|
288007|NCT00928408|O1|Outcome|Cinacalcet|
288008|NCT00928408|O1|Outcome|Cinacalcet|
288009|NCT00928408|O1|Outcome|Cinacalcet|
288010|NCT00928408|O1|Outcome|Cinacalcet|
288011|NCT00928408|O1|Outcome|Cinacalcet|
288012|NCT00928408|O1|Outcome|Cinacalcet|
288013|NCT00928408|O1|Outcome|Cinacalcet|
288014|NCT00928408|O1|Outcome|Cinacalcet|
288015|NCT00928408|O1|Outcome|Cinacalcet|
288016|NCT00928408|O1|Outcome|Cinacalcet|
288017|NCT00928408|O1|Outcome|Cinacalcet|
288018|NCT00928408|O1|Outcome|Cinacalcet|
288019|NCT00928408|O1|Outcome|Cinacalcet|
288020|NCT00928408|O1|Outcome|Cinacalcet|
288021|NCT00928408|E1|Reported Event|Cinacalcet|
288022|NCT00928395|B1|Baseline|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
288030|NCT00928304|O2|Outcome|Down Syndrome PET-negative (Majority Read)|Down Syndrome subjects negative for cerebral beta-amyloid as determined by majority read
289091|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
288034|NCT00928304|O2|Outcome|Majority Read (DS-Old)|Majority Read results for Down Syndrome subjects with age >46 yrs
288035|NCT00928304|O1|Outcome|Majority Read (DS-Young)|Majority Read results for Down Syndrome subjects with age <= 46 yrs
288036|NCT00928304|O1|Outcome|Majority Read|Majority read of the visual assessment made by 3 independent readers of PET images from all subjects.
288037|NCT00928304|E2|Reported Event|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
288038|NCT00928304|E1|Reported Event|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
288039|NCT00928187|B4|Baseline|Total|Total of all reporting groups
288040|NCT00928187|B3|Baseline|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288041|NCT00928187|B2|Baseline|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288042|NCT00928187|B1|Baseline|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288043|NCT00928187|P3|Participant Flow|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288044|NCT00928187|P2|Participant Flow|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288045|NCT00928187|P1|Participant Flow|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288046|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288047|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288048|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288049|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288050|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288051|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288052|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288053|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288054|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288055|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288056|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
289092|NCT00926393|E2|Reported Event|Quetiapine XR|Quetiapine fumarate Extended Release
288057|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288058|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288059|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288060|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288061|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288062|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288063|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288064|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288065|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288066|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288067|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288068|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288069|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288070|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288071|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288072|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288073|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288074|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288075|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288103|NCT00928083|P2|Participant Flow|Part A - OZ439 Single Dose - Cohort 2|OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
288104|NCT00928083|P1|Participant Flow|Part A - OZ439 Single Dose - Cohort 1|OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
288076|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288077|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288078|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288079|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288080|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288081|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288082|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288083|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288084|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288085|NCT00928187|E3|Reported Event|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
288086|NCT00928187|E2|Reported Event|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
288087|NCT00928187|E1|Reported Event|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
288088|NCT00928174|B1|Baseline|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
288089|NCT00928174|P1|Participant Flow|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
288090|NCT00928174|O1|Outcome|Single Arm|"fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
288091|NCT00928174|E1|Reported Event|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
288092|NCT00928083|B4|Baseline|Total|Total of all reporting groups
288093|NCT00928083|B3|Baseline|Part C - OZ439 Multiple Rising Dose|Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
288094|NCT00928083|B2|Baseline|Part B - OZ439 Food Effect|"Subjects were randomized to sequence groups, fasted/fed or fed/fasted while receiving a single dose of 800 mg OZ439."
288095|NCT00928083|B1|Baseline|Part A - OZ439 Single Rising Dose|Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
288096|NCT00928083|P9|Participant Flow|Part C - Placebo|Part C - Placebo
288097|NCT00928083|P8|Participant Flow|Part C - 800mg OZ439 Multiple Dose|OZ439 800mg for 3 consecutive days
288098|NCT00928083|P7|Participant Flow|Part C - 400mg OZ439 Multiple Dose|OZ439 400mg for 3 consecutive days
288099|NCT00928083|P6|Participant Flow|Part C - 200mg OZ439 Multiple Dose|200mg OZ439 for 3 consecutive days
288100|NCT00928083|P5|Participant Flow|Part B - Food Effect - Cohort 2|Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
288101|NCT00928083|P4|Participant Flow|Part B - Food Effect - Cohort 1|Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
288102|NCT00928083|P3|Participant Flow|Part A - OZ439 Single Dose - Cohort 3|Oral Dispersion OZ439 50-1600 mg
289969|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
288105|NCT00928083|O3|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288106|NCT00928083|O2|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288107|NCT00928083|O1|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288108|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288109|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288110|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288111|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288112|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288113|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288114|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288115|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288116|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288117|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288118|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288119|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288120|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288121|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288122|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288123|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288124|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288125|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288126|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288127|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288128|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288129|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288130|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288131|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288132|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288133|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288134|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288135|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288136|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288137|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288138|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288139|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288140|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288141|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288142|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288143|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288144|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288145|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288146|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288147|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288148|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288149|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288150|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288151|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288152|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288153|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288154|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288155|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288156|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288157|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288158|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288159|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288160|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288161|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288162|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288163|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288164|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288165|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288166|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288167|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288168|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288169|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288170|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288171|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288172|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288173|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288174|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288175|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288176|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288177|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288178|NCT00928083|O17|Outcome|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
288179|NCT00928083|O16|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288180|NCT00928083|O15|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288181|NCT00928083|O14|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288182|NCT00928083|O13|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288183|NCT00928083|O12|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288184|NCT00928083|O11|Outcome|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
288185|NCT00928083|O10|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288186|NCT00928083|O9|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288187|NCT00928083|O8|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288188|NCT00928083|O7|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288189|NCT00928083|O6|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288190|NCT00928083|O5|Outcome|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288191|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288192|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288193|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288194|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
289970|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
288196|NCT00928083|E16|Reported Event|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
288197|NCT00928083|E15|Reported Event|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
288198|NCT00928083|E14|Reported Event|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
288199|NCT00928083|E13|Reported Event|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
288200|NCT00928083|E12|Reported Event|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
288201|NCT00928083|E11|Reported Event|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
288202|NCT00928083|E10|Reported Event|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
288203|NCT00928083|E9|Reported Event|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
288204|NCT00928083|E8|Reported Event|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
288205|NCT00928083|E7|Reported Event|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
288206|NCT00928083|E6|Reported Event|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
288207|NCT00928083|E5|Reported Event|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288208|NCT00928083|E4|Reported Event|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
288209|NCT00928083|E3|Reported Event|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
288210|NCT00928083|E2|Reported Event|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
288211|NCT00928083|E1|Reported Event|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
288212|NCT00928070|B3|Baseline|Total|Total of all reporting groups
288213|NCT00928070|B2|Baseline|Fesoterodine|Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288214|NCT00928070|B1|Baseline|Placebo|Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288215|NCT00928070|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288216|NCT00928070|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288217|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288218|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288219|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288220|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288221|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288222|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288223|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288224|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288225|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288226|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288227|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288228|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288229|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288230|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
289093|NCT00926393|E1|Reported Event|Quetiapine IR|Quetiapine fumarate Immediate Release
288231|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288232|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288233|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288234|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288235|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288236|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288237|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288238|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288239|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288240|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288241|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288242|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288243|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288244|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288245|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288246|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288247|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288248|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288249|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288250|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288251|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288252|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288253|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288254|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288255|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288256|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288257|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288258|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288259|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288260|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288261|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288262|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288263|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288264|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288265|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288266|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288267|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288268|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288269|NCT00928070|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
288270|NCT00928070|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
288271|NCT00928057|B3|Baseline|Total|Total of all reporting groups
288272|NCT00928057|B2|Baseline|4 mm / 5 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.
288273|NCT00928057|B1|Baseline|4 mm / 8 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.
288274|NCT00928057|P2|Participant Flow|4 mm / 5 mm PN|This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
288275|NCT00928057|P1|Participant Flow|4 mm / 8 mm PN|This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
288276|NCT00928057|O3|Outcome|8 mm PN|Use of 8 mm PN for insulin injections for 3 weeks.
288277|NCT00928057|O2|Outcome|5 mm PN|Use of 5 mm PN for insulin injections for 3 weeks.
288278|NCT00928057|O1|Outcome|4 mm PN|Use of 4 mm PN for insulin injections for 3 weeks.
288279|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288280|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288281|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN
288282|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN
288283|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN
288284|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
288285|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
288286|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
288287|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
288288|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
288289|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
288290|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288291|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288292|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288293|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
288294|NCT00928057|E3|Reported Event|4mm PN|All randomized subjects that used the 4mm pen needle.
288295|NCT00928057|E2|Reported Event|5mm PN|All randomized subjects that used the 5 mm pen needle.
288296|NCT00928057|E1|Reported Event|8mm PN|All randomized subjects that used the 8 mm pen needle.
288297|NCT00928018|B3|Baseline|Total|Total of all reporting groups
288345|NCT00927940|B1|Baseline|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
288346|NCT00927940|P1|Participant Flow|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
288347|NCT00927940|O1|Outcome|Zotarolims Eluting Stent|
288348|NCT00927940|O1|Outcome|Zotarolimus Eluting Stent|100 lesion of 100 ITT patients were subjected for this analysis.
288361|NCT00927927|B5|Baseline|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
288298|NCT00928018|B2|Baseline|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288299|NCT00928018|B1|Baseline|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288300|NCT00928018|P2|Participant Flow|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288301|NCT00928018|P1|Participant Flow|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288302|NCT00928018|O4|Outcome|Aggressive Group: Sirolimus-Free Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
288303|NCT00928018|O3|Outcome|Aggressive Group: Sirolimus-Containing Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
288304|NCT00928018|O2|Outcome|Indolent Group: Sirolimus-Free Regimen|"Indolent group: indolent B-cell NHL, CLL and HL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
288305|NCT00928018|O1|Outcome|Indolent Group: Sirolimus-Containing Regimen|"Indolent group:indolent B-cell NHL, CLL and HL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
288349|NCT00927940|E1|Reported Event|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
288350|NCT00927927|B16|Baseline|Total|Total of all reporting groups
288351|NCT00927927|B15|Baseline|MD Placebo|Subjects were injected biweekly four times with placebo
288352|NCT00927927|B14|Baseline|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
289094|NCT00926367|B3|Baseline|Total|Total of all reporting groups
288306|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288307|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288308|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288309|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288310|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288311|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288312|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288313|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288353|NCT00927927|B13|Baseline|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
288354|NCT00927927|B12|Baseline|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
288355|NCT00927927|B11|Baseline|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
288356|NCT00927927|B10|Baseline|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
288357|NCT00927927|B9|Baseline|SD Placebo|Subjects were dosed once with placebo
288358|NCT00927927|B8|Baseline|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
288314|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288315|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288316|NCT00928018|E2|Reported Event|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
288317|NCT00928018|E1|Reported Event|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
288318|NCT00927992|B1|Baseline|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288319|NCT00927992|P1|Participant Flow|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288320|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288321|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288322|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288323|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288324|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288325|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288326|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288327|NCT00927992|E1|Reported Event|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
288328|NCT00927953|B3|Baseline|Total|Total of all reporting groups
288329|NCT00927953|B2|Baseline|Placebo - Normal Saline|single intravenous infusion of saline placebo
288330|NCT00927953|B1|Baseline|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288331|NCT00927953|P2|Participant Flow|Placebo - Normal Saline|single intravenous infusion of saline placebo
288332|NCT00927953|P1|Participant Flow|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288333|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
288334|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288335|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
288336|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288337|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
288338|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288339|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
288340|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288341|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
288342|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288343|NCT00927953|E2|Reported Event|Placebo - Normal Saline|single intravenous infusion of saline placebo
288344|NCT00927953|E1|Reported Event|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
288359|NCT00927927|B7|Baseline|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
288360|NCT00927927|B6|Baseline|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
288362|NCT00927927|B4|Baseline|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
288363|NCT00927927|B3|Baseline|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
288364|NCT00927927|B2|Baseline|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
288365|NCT00927927|B1|Baseline|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
288366|NCT00927927|P15|Participant Flow|MD Placebo|Subjects were injected biweekly four times with placebo
288367|NCT00927927|P14|Participant Flow|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
288368|NCT00927927|P13|Participant Flow|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
288369|NCT00927927|P12|Participant Flow|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
288370|NCT00927927|P11|Participant Flow|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
288371|NCT00927927|P10|Participant Flow|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
288372|NCT00927927|P9|Participant Flow|SD Placebo|Subjects were dosed once with placebo
288373|NCT00927927|P8|Participant Flow|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
288374|NCT00927927|P7|Participant Flow|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
288375|NCT00927927|P6|Participant Flow|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
288376|NCT00927927|P5|Participant Flow|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
288377|NCT00927927|P4|Participant Flow|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
288378|NCT00927927|P3|Participant Flow|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
288379|NCT00927927|P2|Participant Flow|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
288380|NCT00927927|P1|Participant Flow|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
288381|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
288382|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
288383|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
288384|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
288385|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
288386|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
288387|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
288388|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
288389|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
288390|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
288391|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
288392|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
288393|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
288394|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
288395|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
288396|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
288397|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
288398|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
288399|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
288400|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
288401|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
288402|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
288403|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
288404|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
288405|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
288406|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
288407|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
288408|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
288409|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
288410|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
288411|NCT00927927|E15|Reported Event|MD Placebo|Subjects were injected biweekly four times with placebo
288412|NCT00927927|E14|Reported Event|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
288413|NCT00927927|E13|Reported Event|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
288414|NCT00927927|E12|Reported Event|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
288415|NCT00927927|E11|Reported Event|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
288416|NCT00927927|E10|Reported Event|SD Placebo|Subjects were dosed once with placebo
288417|NCT00927927|E9|Reported Event|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
288418|NCT00927927|E8|Reported Event|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
288419|NCT00927927|E7|Reported Event|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
288420|NCT00927927|E6|Reported Event|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
288421|NCT00927927|E5|Reported Event|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
288422|NCT00927927|E4|Reported Event|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
288423|NCT00927927|E3|Reported Event|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
288424|NCT00927927|E2|Reported Event|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
288425|NCT00927927|E1|Reported Event|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
288426|NCT00927901|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288427|NCT00927901|P4|Participant Flow|Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate|In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288428|NCT00927901|P3|Participant Flow|Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate|In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288429|NCT00927901|P2|Participant Flow|Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo|In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288430|NCT00927901|P1|Participant Flow|Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate|In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288431|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288432|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288433|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288434|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288435|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288436|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288502|NCT00927849|O1|Outcome|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
289971|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
288437|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288438|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288439|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|3Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288440|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288441|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288442|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288443|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288444|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288445|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288446|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288447|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288448|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288449|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288450|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288451|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288452|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288453|NCT00927901|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288454|NCT00927901|E3|Reported Event|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
289140|NCT00926328|P2|Participant Flow|Placebo Control|sodium fluoride toothpaste
288455|NCT00927901|E2|Reported Event|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288456|NCT00927901|E1|Reported Event|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
288457|NCT00927888|B3|Baseline|Total|Total of all reporting groups
288458|NCT00927888|B2|Baseline|Group 2 - Saline Placebo Group|Saline substituted in block, placebo treatment group with application of saline block before FESS.
288459|NCT00927888|B1|Baseline|Group 1 Bupivacaine|Active treatment group with application of bupivacaine block before FESS.
288460|NCT00927888|P2|Participant Flow|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
288461|NCT00927888|P1|Participant Flow|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
288462|NCT00927888|O2|Outcome|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
288463|NCT00927888|O1|Outcome|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
288464|NCT00927888|O2|Outcome|2 - Placebo|Normal saline with Epi 1:100,000 (B block)
288465|NCT00927888|O1|Outcome|1 - Bupivacaine Block|"3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)~Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure."
288466|NCT00927888|E2|Reported Event|Group 2 - Saline Placebo Block|Placebo treatment group with application of saline block before FESS.
288467|NCT00927888|E1|Reported Event|Group 1 - Bupicaine Block|Active treatment group with application of bupivacaine block before FESS.
288468|NCT00927862|B3|Baseline|Total|Total of all reporting groups
288469|NCT00927862|B2|Baseline|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
288470|NCT00927862|B1|Baseline|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
288471|NCT00927862|P2|Participant Flow|Parellel/Historical Controls|A parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified.
288472|NCT00927862|P1|Participant Flow|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms were randomized to receive either standard or modified International Warfarin Pharmacogenetics Consortium [IWPC] warfarin dosing. The IWPC derived and published a common algorithm to predict stable maintenance dose based on ~5000 patients across broad geographic and ethnic/racial groups (N Engl J Med 2009;360:753-764). Hence, we based our standard algorithm on the IWPC algorithm with minor modifications to accommodate different INR targets and smoking status, based on supplemental data from Gage et al (Clini Pharmacol Ther 2008;84:326 -331). The modified IWPC algorithm included 2 further modifications: (1) It ignored the CYP2C9 variant status for the first 2 days; and (2) It used a special dose-revision algorithm based on a day 4 (or day 5) INR after 3 (or 4) warfarin doses.
288473|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
288474|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
288475|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
288476|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
288477|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
288478|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
289141|NCT00926328|P1|Participant Flow|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
288479|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
288480|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
288481|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
288482|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
288483|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
288484|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
288485|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
288486|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
288487|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
288488|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
288489|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
288490|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
288491|NCT00927862|E2|Reported Event|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
288492|NCT00927862|E1|Reported Event|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
288493|NCT00927849|B4|Baseline|Total|Total of all reporting groups
288494|NCT00927849|B3|Baseline|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
288495|NCT00927849|B2|Baseline|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
288496|NCT00927849|B1|Baseline|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
288497|NCT00927849|P3|Participant Flow|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
288498|NCT00927849|P2|Participant Flow|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
288499|NCT00927849|P1|Participant Flow|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
288500|NCT00927849|O3|Outcome|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
288501|NCT00927849|O2|Outcome|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
289142|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
288503|NCT00927849|E3|Reported Event|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
288504|NCT00927849|E2|Reported Event|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
288505|NCT00927849|E1|Reported Event|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
288506|NCT00927823|B1|Baseline|Entire Study Population|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288507|NCT00927823|P4|Participant Flow|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288508|NCT00927823|P3|Participant Flow|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288509|NCT00927823|P2|Participant Flow|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288510|NCT00927823|P1|Participant Flow|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288511|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288512|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288513|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288514|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288515|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288516|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288517|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288518|NCT00927823|O2|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288519|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288520|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288521|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288522|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288523|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288641|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288524|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288525|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288526|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288527|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288528|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288529|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288530|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288531|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288532|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288533|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288534|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288535|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288536|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288537|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288538|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288539|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288540|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288541|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288542|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288543|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288544|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
288545|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
289143|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
288546|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
288547|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
288548|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288549|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288550|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288551|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288552|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288553|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288554|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288555|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288556|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288557|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288558|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288559|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288560|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288561|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288562|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288563|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288564|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288565|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288566|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288567|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288568|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288569|NCT00927823|E4|Reported Event|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288570|NCT00927823|E3|Reported Event|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288571|NCT00927823|E2|Reported Event|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288572|NCT00927823|E1|Reported Event|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
288573|NCT00927758|B1|Baseline|All Randomized Patients|Baseline measured for all randomized (safety set) patients.
288574|NCT00927758|P6|Participant Flow|Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288575|NCT00927758|P5|Participant Flow|Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288576|NCT00927758|P4|Participant Flow|Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288577|NCT00927758|P3|Participant Flow|Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288578|NCT00927758|P2|Participant Flow|Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288579|NCT00927758|P1|Participant Flow|Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
288580|NCT00927758|O3|Outcome|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
288581|NCT00927758|O2|Outcome|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
288582|NCT00927758|O1|Outcome|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
288583|NCT00927758|E3|Reported Event|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
288584|NCT00927758|E2|Reported Event|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
288585|NCT00927758|E1|Reported Event|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
288586|NCT00927589|B1|Baseline|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288642|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288643|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
289144|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
288587|NCT00927589|P1|Participant Flow|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 milligrams per kilogram (mg/kg) of body weight given by intravenous (IV) infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 milligrams per square meter (mg/m^2) of body surface area (BSA) on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target area under the concentration-versus-time curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288588|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288589|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288590|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288591|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288592|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288593|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288594|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288595|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288596|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
289972|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
288597|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288598|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288599|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288600|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288601|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288602|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288603|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288604|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288605|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288606|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288644|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288607|NCT00927589|E1|Reported Event|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
288608|NCT00927576|B3|Baseline|Total|Total of all reporting groups
288609|NCT00927576|B2|Baseline|TBI Patients|TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
288610|NCT00927576|B1|Baseline|Control Subjects|Control subjects = 230. Normal control subjects of various ages.
288611|NCT00927576|P2|Participant Flow|TBI Patients|TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
288612|NCT00927576|P1|Participant Flow|Control Subjects|Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
288613|NCT00927576|O1|Outcome|Simple Reaction Time Test|time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
288614|NCT00927576|E2|Reported Event|TBI Patients|TBI patients N = 28. No adverse events were observed
288615|NCT00927576|E1|Reported Event|Control Subjects|Control subjects = 237. No adverse events were observed.
288616|NCT00927563|B1|Baseline|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288617|NCT00927563|P1|Participant Flow|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288618|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288619|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288620|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288621|NCT00927563|E1|Reported Event|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
288622|NCT00927472|B3|Baseline|Total|Total of all reporting groups
288623|NCT00927472|B2|Baseline|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288624|NCT00927472|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288625|NCT00927472|P2|Participant Flow|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288626|NCT00927472|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288627|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288628|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288629|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288630|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288631|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288632|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288633|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288634|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288635|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288636|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288637|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288638|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288639|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288640|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288680|NCT00927368|B4|Baseline|Total|Total of all reporting groups
289973|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
288645|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288646|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288647|NCT00927472|E2|Reported Event|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
288648|NCT00927472|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
288649|NCT00927394|B3|Baseline|Total|Total of all reporting groups
288650|NCT00927394|B2|Baseline|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288651|NCT00927394|B1|Baseline|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288652|NCT00927394|P2|Participant Flow|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288653|NCT00927394|P1|Participant Flow|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288654|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288655|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288656|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288657|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288658|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288659|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288660|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288661|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288662|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288663|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288664|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288665|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288666|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288667|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288668|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288669|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288670|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288671|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288672|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288673|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288674|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288675|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288676|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288677|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
288678|NCT00927394|E2|Reported Event|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
288679|NCT00927394|E1|Reported Event|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
288681|NCT00927368|B3|Baseline|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288682|NCT00927368|B2|Baseline|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288683|NCT00927368|B1|Baseline|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288684|NCT00927368|P3|Participant Flow|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288685|NCT00927368|P2|Participant Flow|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288686|NCT00927368|P1|Participant Flow|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288687|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288688|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288689|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288703|NCT00927355|P1|Participant Flow|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
288704|NCT00927355|O4|Outcome|Placebo - Lumbar Spine BMD|The other half will be randomized to placebo.
288705|NCT00927355|O3|Outcome|Pioglitazone -Lumbar Spine BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
289974|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
288690|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288691|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288692|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288693|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288694|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288695|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288696|NCT00927368|E3|Reported Event|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
288697|NCT00927368|E2|Reported Event|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
288698|NCT00927368|E1|Reported Event|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
288699|NCT00927355|B3|Baseline|Total|Total of all reporting groups
288700|NCT00927355|B2|Baseline|Placebo|The other half will be randomized to placebo.
288701|NCT00927355|B1|Baseline|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
288702|NCT00927355|P2|Participant Flow|Placebo|The other half will be randomized to placebo, starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
288706|NCT00927355|O2|Outcome|Placebo-Femoral Neck BMD|The other half will be randomized to placebo.
288707|NCT00927355|O1|Outcome|Pioglitazone-Femoral Neck BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
288708|NCT00927355|O6|Outcome|Placebo - Osc|serum Osteocalcin percent change 6 mo after placebo Rx compared to baseline.
288709|NCT00927355|O5|Outcome|Pioglitazone-OSc|serum Osteocalcin percent change 6 mo after pioglitazone Rx compared to baseline.
288710|NCT00927355|O4|Outcome|Placebo-CTX|serum CTX percent change 6 mo after placebo Rx compared to baseline.
288711|NCT00927355|O3|Outcome|Pioglitazone-CTX|serum CTX percent change 6 mo after pioglitazone Rx compared to baseline.
288712|NCT00927355|O2|Outcome|Placebo-Adiponectin|serum adiponectin percent change 6 mo after placebo Rx compared to baseline.
288713|NCT00927355|O1|Outcome|Pioglitazone-Adiponectin|serum adiponectin percent change 6 mo after study drug Rx compared to baseline.
288714|NCT00927355|O4|Outcome|Placebo-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O, at baseline and 6 months after treatment with study drug.
288715|NCT00927355|O3|Outcome|Pioglitazone-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O at baseline and 6 months after treatment with study drug.
288716|NCT00927355|O2|Outcome|Placebo-OSteoblast CFU|Percent change in Osteoblast CFU numbers as stained with Alizarin at baseline and 6 months after treatment with study drug.
288717|NCT00927355|O1|Outcome|Pioglitazone-Osteoblast CFU (Colony Forming Units)|Percent change in Osteoblast CFU numbers as stained with Alizarin red S at baseline and 6 months after treatment with study drug.
288718|NCT00927355|E2|Reported Event|Placebo|The other half will be randomized to placebo.
288719|NCT00927355|E1|Reported Event|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
288720|NCT00927251|B1|Baseline|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
288721|NCT00927251|P1|Participant Flow|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
288722|NCT00927251|O1|Outcome|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
288723|NCT00927251|E1|Reported Event|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
288724|NCT00927186|B3|Baseline|Total|Total of all reporting groups
288725|NCT00927186|B2|Baseline|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288726|NCT00927186|B1|Baseline|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288727|NCT00927186|P2|Participant Flow|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288728|NCT00927186|P1|Participant Flow|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288729|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288730|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288731|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288732|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288733|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288734|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288735|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288736|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288737|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288738|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288739|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288740|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288741|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288742|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288743|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288744|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288745|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288746|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288747|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288748|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288749|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288750|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288751|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288752|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288753|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288754|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288755|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288756|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288757|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288758|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288759|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288760|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288761|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288762|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288763|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288764|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288765|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288766|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288767|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288768|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288769|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288770|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288771|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288772|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288773|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288774|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288775|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288776|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288777|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288778|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288779|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288780|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288781|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288782|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288783|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288784|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288785|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288786|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288787|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288788|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288789|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288790|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288791|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288792|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288793|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288794|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288795|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension"
288796|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288797|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288798|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288799|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288800|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288801|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288802|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288803|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288804|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288805|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288806|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288807|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288808|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288809|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288810|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288811|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288812|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288813|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288814|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288815|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288816|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288817|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288818|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288819|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288820|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288821|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288822|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288823|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288824|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288825|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288826|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288827|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288828|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288829|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288830|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288831|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288832|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288833|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288834|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288835|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288836|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288837|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288838|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
288839|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288840|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288841|NCT00927186|E2|Reported Event|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288842|NCT00927186|E1|Reported Event|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
288843|NCT00927160|B3|Baseline|Total|Total of all reporting groups
288844|NCT00927160|B2|Baseline|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
288845|NCT00927160|B1|Baseline|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
288846|NCT00927160|P2|Participant Flow|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
288847|NCT00927160|P1|Participant Flow|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
288848|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
288849|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
288850|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
288851|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
288852|NCT00927160|E2|Reported Event|Usual Care|Matching group of patients admitted to general medical service
288853|NCT00927160|E1|Reported Event|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
288854|NCT00927095|B4|Baseline|Total|Total of all reporting groups
288855|NCT00927095|B3|Baseline|Continuous Placebo|"continuous placebo~placebo: daily"
288856|NCT00927095|B2|Baseline|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
288857|NCT00927095|B1|Baseline|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
288858|NCT00927095|P3|Participant Flow|Continuous Placebo|"continuous placebo~placebo: daily"
288859|NCT00927095|P2|Participant Flow|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
288860|NCT00927095|P1|Participant Flow|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
288861|NCT00927095|O3|Outcome|Continuous Placebo|"continuous placebo~placebo: daily"
288862|NCT00927095|O2|Outcome|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
288863|NCT00927095|O1|Outcome|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
288864|NCT00927095|E3|Reported Event|Continuous Placebo|"continuous placebo~placebo: daily"
288906|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288865|NCT00927095|E2|Reported Event|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
288866|NCT00927095|E1|Reported Event|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
288867|NCT00927082|B5|Baseline|Total|Total of all reporting groups
288868|NCT00927082|B4|Baseline|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288869|NCT00927082|B3|Baseline|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288870|NCT00927082|B2|Baseline|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288871|NCT00927082|B1|Baseline|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288872|NCT00927082|P4|Participant Flow|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288873|NCT00927082|P3|Participant Flow|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288874|NCT00927082|P2|Participant Flow|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288875|NCT00927082|P1|Participant Flow|PEG-IFN 90mcg 24 Wks|Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
288876|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288877|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288878|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288879|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288880|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288881|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288882|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288883|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288884|NCT00927082|O4|Outcome|Group D|Participants received 180 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288885|NCT00927082|O3|Outcome|Group C|Participants received 90 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288886|NCT00927082|O2|Outcome|Group B|Participants received 180 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288887|NCT00927082|O1|Outcome|Group A|Participants received 90 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288888|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288889|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288890|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288891|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288892|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288893|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288894|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288895|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288896|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288897|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288898|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288899|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288900|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288901|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288902|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288903|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288904|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288905|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
289081|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
288907|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288908|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288909|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288910|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288911|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288912|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288913|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288914|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288915|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288916|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288917|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288918|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288919|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288920|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288921|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288922|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288923|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288924|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288925|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288926|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288927|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288928|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288929|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288930|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288931|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288932|NCT00927082|E4|Reported Event|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288933|NCT00927082|E3|Reported Event|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
288934|NCT00927082|E2|Reported Event|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288935|NCT00927082|E1|Reported Event|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
288936|NCT00927069|B3|Baseline|Total|Total of all reporting groups
288937|NCT00927069|B2|Baseline|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
288938|NCT00927069|B1|Baseline|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
288939|NCT00927069|P4|Participant Flow|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
288940|NCT00927069|P3|Participant Flow|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
288941|NCT00927069|P2|Participant Flow|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
288942|NCT00927069|P1|Participant Flow|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
288943|NCT00927069|O2|Outcome|Group B|Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
288944|NCT00927069|O1|Outcome|Group A|Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
288945|NCT00927069|O1|Outcome|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
289082|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
288946|NCT00927069|O1|Outcome|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
288947|NCT00927069|O1|Outcome|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
288948|NCT00927069|O1|Outcome|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
288949|NCT00927069|E2|Reported Event|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
288950|NCT00927069|E1|Reported Event|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
288951|NCT00926952|B1|Baseline|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288952|NCT00926952|P1|Participant Flow|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288953|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288954|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288955|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288956|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288957|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288958|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288959|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288960|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288961|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288962|NCT00926952|E1|Reported Event|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
288963|NCT00926887|B3|Baseline|Total|Total of all reporting groups
288964|NCT00926887|B2|Baseline|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288965|NCT00926887|B1|Baseline|Placebo Laser|inactive light
288966|NCT00926887|P2|Participant Flow|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288967|NCT00926887|P1|Participant Flow|Placebo Laser|inactive light
288968|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288969|NCT00926887|O1|Outcome|Placebo Laser|inactive light
288970|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288971|NCT00926887|O1|Outcome|Placebo Laser|inactive light
288972|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288973|NCT00926887|O1|Outcome|Placebo Laser|inactive light
288974|NCT00926887|E2|Reported Event|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
288975|NCT00926887|E1|Reported Event|Placebo Laser|inactive light
288976|NCT00926796|B3|Baseline|Total|Total of all reporting groups
288977|NCT00926796|B2|Baseline|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288978|NCT00926796|B1|Baseline|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288979|NCT00926796|P2|Participant Flow|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288980|NCT00926796|P1|Participant Flow|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288981|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288982|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
289083|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
288983|NCT00926796|O1|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288984|NCT00926796|O1|Outcome|Baseline|All per protocol participants at baseline with evaluable isolates
288985|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288986|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288987|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288988|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288989|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288990|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288991|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288992|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288993|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288994|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288995|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288996|NCT00926796|E2|Reported Event|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
288997|NCT00926796|E1|Reported Event|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
288998|NCT00926783|B3|Baseline|Total|Total of all reporting groups
288999|NCT00926783|B2|Baseline|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289000|NCT00926783|B1|Baseline|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289001|NCT00926783|P2|Participant Flow|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289002|NCT00926783|P1|Participant Flow|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289003|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289004|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289005|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289006|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289084|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289085|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289086|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289007|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289008|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289009|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289010|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289011|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289012|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289013|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289014|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289015|NCT00926783|E2|Reported Event|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
289016|NCT00926783|E1|Reported Event|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
289017|NCT00926588|B3|Baseline|Total|Total of all reporting groups
289018|NCT00926588|B2|Baseline|Usual Care|Patients receive usual care for pain from their primary care physician
289019|NCT00926588|B1|Baseline|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
289020|NCT00926588|P2|Participant Flow|Usual Care|Patients receive usual care for pain from their primary care physician
289021|NCT00926588|P1|Participant Flow|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
289022|NCT00926588|O2|Outcome|Usual Care|Patients receive usual care for pain from their primary care physician
289023|NCT00926588|O1|Outcome|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
289024|NCT00926588|E2|Reported Event|Usual Care|Patients receive usual care for pain from their primary care physician
289087|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289088|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289089|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289090|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289025|NCT00926588|E1|Reported Event|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
289026|NCT00926575|B3|Baseline|Total|Total of all reporting groups
289027|NCT00926575|B2|Baseline|Placebo|
289028|NCT00926575|B1|Baseline|Active|oral beclomethasone 17,21-dipropionate (BDP)
289029|NCT00926575|P2|Participant Flow|Placebo|
289030|NCT00926575|P1|Participant Flow|Active|oral beclomethasone 17,21-dipropionate (BDP)
289031|NCT00926575|O2|Outcome|Placebo|
289032|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
289033|NCT00926575|O2|Outcome|Placebo|
289034|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
289035|NCT00926575|O2|Outcome|Placebo|
289036|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
289037|NCT00926575|E2|Reported Event|Placebo|
289038|NCT00926575|E1|Reported Event|Active|oral beclomethasone 17,21-dipropionate (BDP)
289039|NCT00926536|B3|Baseline|Total|Total of all reporting groups
289040|NCT00926536|B2|Baseline|DSA Only|DSA images only used for vessel navigation and tracking
289041|NCT00926536|B1|Baseline|C-arm CT + DSA as Needed|C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking
289042|NCT00926536|P2|Participant Flow|DSA Only|Only Digital subtraction images used for vessel tracking and tumor navigation
289043|NCT00926536|P1|Participant Flow|C-arm CT +DSA as Needed|C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation
289044|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
289045|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
289046|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
289047|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
289048|NCT00926536|E2|Reported Event|DSA Only|DSA only used for navigation
289049|NCT00926536|E1|Reported Event|C-arm CT + DSA as Needed|C-arm CT used for the purposes of navigation, supplemented by DSA if needed
289050|NCT00926497|B3|Baseline|Total|Total of all reporting groups
289051|NCT00926497|B2|Baseline|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
289052|NCT00926497|B1|Baseline|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
289053|NCT00926497|P2|Participant Flow|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
289054|NCT00926497|P1|Participant Flow|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
289055|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
289056|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
289057|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
289058|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
289059|NCT00926497|E2|Reported Event|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
289060|NCT00926497|E1|Reported Event|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
289061|NCT00926393|B3|Baseline|Total|Total of all reporting groups
289062|NCT00926393|B2|Baseline|Quetiapine XR|Quetiapine fumarate Extended Release
289063|NCT00926393|B1|Baseline|Quetiapine IR|Quetiapine fumarate Immediate Release
289064|NCT00926393|P2|Participant Flow|Quetiapine XR|Quetiapine fumarate Extended Release
289065|NCT00926393|P1|Participant Flow|Quetiapine IR|Quetiapine fumarate Immediate Release
289066|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289067|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289068|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289069|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289070|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289071|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289072|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289073|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289074|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289075|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289076|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289077|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289078|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289079|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
289080|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
289975|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289095|NCT00926367|B2|Baseline|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289096|NCT00926367|B1|Baseline|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289097|NCT00926367|P2|Participant Flow|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289098|NCT00926367|P1|Participant Flow|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289099|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289100|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289101|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289102|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289103|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289104|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289105|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289106|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289107|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289108|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289109|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289110|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289111|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289112|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289113|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289114|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289115|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289116|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289117|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289118|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289119|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289120|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289121|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289122|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289123|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289124|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289125|NCT00926367|O2|Outcome|Epiduo|Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289126|NCT00926367|O1|Outcome|Duac|Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289127|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289128|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289129|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289130|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289131|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289132|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289133|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289134|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289135|NCT00926367|E2|Reported Event|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
289136|NCT00926367|E1|Reported Event|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
289137|NCT00926328|B3|Baseline|Total|Total of all reporting groups
289138|NCT00926328|B2|Baseline|Placebo Control|sodium fluoride toothpaste
289139|NCT00926328|B1|Baseline|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
289145|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
289146|NCT00926328|E2|Reported Event|Placebo Control|sodium fluoride toothpaste
289147|NCT00926328|E1|Reported Event|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
289148|NCT00926289|B3|Baseline|Total|Total of all reporting groups
289149|NCT00926289|B2|Baseline|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289150|NCT00926289|B1|Baseline|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289151|NCT00926289|P2|Participant Flow|Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289152|NCT00926289|P1|Participant Flow|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289153|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289154|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289155|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289156|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289157|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289158|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289159|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289160|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289161|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289162|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289163|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289164|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289165|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289166|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289167|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289168|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289169|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289170|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289171|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289172|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289173|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289174|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289175|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289176|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289177|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289178|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289179|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289180|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289181|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289182|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289183|NCT00926289|E2|Reported Event|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
289184|NCT00926289|E1|Reported Event|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
289185|NCT00926263|B3|Baseline|Total|Total of all reporting groups
289186|NCT00926263|B2|Baseline|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289187|NCT00926263|B1|Baseline|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289188|NCT00926263|P2|Participant Flow|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289976|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289189|NCT00926263|P1|Participant Flow|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289190|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289191|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289192|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289193|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289194|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289195|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289196|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289197|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289198|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289199|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289200|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289201|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289202|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289203|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289204|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289205|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289206|NCT00926263|O1|Outcome|CP-751,871 20/20 mg/kg|Participants not enrolled due to early termination of the study.
289207|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289208|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289209|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289210|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289211|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289212|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289213|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289214|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289215|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289216|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289217|NCT00926263|E2|Reported Event|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289218|NCT00926263|E1|Reported Event|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
289219|NCT00926211|B1|Baseline|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
289220|NCT00926211|P1|Participant Flow|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
289221|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
289222|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
289223|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
289224|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
289225|NCT00926211|E1|Reported Event|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
289226|NCT00926029|B4|Baseline|Total|Total of all reporting groups
289227|NCT00926029|B3|Baseline|Experimental|triclosan/fluoride/zinc toothpaste
289228|NCT00926029|B2|Baseline|Positive Control|triclosan/fluoride toothpaste
289229|NCT00926029|B1|Baseline|Placebo Control|fluoride toothpaste
289230|NCT00926029|P3|Participant Flow|Experimental|triclosan/fluoride/metal salt toothpaste
289231|NCT00926029|P2|Participant Flow|Positive Control|triclosan/fluoride toothpaste
289232|NCT00926029|P1|Participant Flow|Placebo Control|fluoride toothpaste (Winterfresh Gel)
289233|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/zinc toothpaste
289234|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
289235|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste
289236|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/metal salt toothpaste
289237|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
289977|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289238|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste (Winterfresh Gel)
289239|NCT00926029|E3|Reported Event|Experimental|triclosan/fluoride/metal salt toothpaste
289240|NCT00926029|E2|Reported Event|Positive Control|triclosan/fluoride toothpaste
289241|NCT00926029|E1|Reported Event|Placebo Control|fluoride toothpaste (Winterfresh Gel)
289242|NCT00925990|B3|Baseline|Total|Total of all reporting groups
289243|NCT00925990|B2|Baseline|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
289244|NCT00925990|B1|Baseline|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
289245|NCT00925990|P2|Participant Flow|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
289246|NCT00925990|P1|Participant Flow|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
289247|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
289248|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
289249|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
289250|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
289251|NCT00925990|E2|Reported Event|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
289252|NCT00925990|E1|Reported Event|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
289253|NCT00925938|B4|Baseline|Total|Total of all reporting groups
289254|NCT00925938|B3|Baseline|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289255|NCT00925938|B2|Baseline|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289256|NCT00925938|B1|Baseline|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289257|NCT00925938|P3|Participant Flow|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289258|NCT00925938|P2|Participant Flow|MVPI 800 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB)."
289259|NCT00925938|P1|Participant Flow|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289260|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289261|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289262|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289263|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289264|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289265|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289266|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289267|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289268|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289269|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289270|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289271|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289272|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289273|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289274|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289275|NCT00925938|E3|Reported Event|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
289276|NCT00925938|E2|Reported Event|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
289277|NCT00925938|E1|Reported Event|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
289278|NCT00925782|B1|Baseline|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
289279|NCT00925782|P2|Participant Flow|Alkeran - Melphalan|"Randomized group of Alkeran-Melphalan~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
289280|NCT00925782|P1|Participant Flow|Melphalan - Alkeran|"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
289281|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
289282|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
289283|NCT00925782|O1|Outcome|Open-label, Randomized, Crossover Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
289284|NCT00925782|O1|Outcome|Open-label, Randomized, Cross-over Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
289285|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
289286|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
289287|NCT00925782|E1|Reported Event|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
289288|NCT00925769|B1|Baseline|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (Dose levels [DL]-1, 2, 3, 4, 5 and 6) were administered either oral 100 mg or 150 mg of erlotinib tablet daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289289|NCT00925769|P6|Participant Flow|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289290|NCT00925769|P5|Participant Flow|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289291|NCT00925769|P4|Participant Flow|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289292|NCT00925769|P3|Participant Flow|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289293|NCT00925769|P2|Participant Flow|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289294|NCT00925769|P1|Participant Flow|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 milligrams (mg) of erlotinib (ERL) tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 milligrams per kilogram (mg/kg) of bevacizumab (BEV) intravenous (IV) infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 milligrams per square meter (mg/m^2) of capecitabine (CAP) tablet twice daily (BID) within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289295|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289296|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289297|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289298|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289405|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289299|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289300|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289301|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289302|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289303|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289304|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289305|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289306|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289307|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289308|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289309|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289310|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289311|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289312|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289313|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289314|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289406|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289315|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289316|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289317|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289318|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289319|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289320|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289321|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289322|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289323|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289324|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289325|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289326|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289327|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289328|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289329|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289330|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289407|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289331|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289332|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289333|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289334|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289335|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289336|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289337|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289338|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289339|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289340|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289341|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289342|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289343|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289344|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289345|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289408|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289346|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289347|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289348|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289349|NCT00925769|E6|Reported Event|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289350|NCT00925769|E5|Reported Event|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289351|NCT00925769|E4|Reported Event|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289352|NCT00925769|E3|Reported Event|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289353|NCT00925769|E2|Reported Event|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289354|NCT00925769|E1|Reported Event|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
289355|NCT00925704|B7|Baseline|Total|Total of all reporting groups
289356|NCT00925704|B6|Baseline|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
289357|NCT00925704|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
289358|NCT00925704|B4|Baseline|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
289359|NCT00925704|B3|Baseline|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
289360|NCT00925704|B2|Baseline|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
289361|NCT00925704|B1|Baseline|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
289409|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289410|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289362|NCT00925704|P6|Participant Flow|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
289363|NCT00925704|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
289364|NCT00925704|P4|Participant Flow|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
289365|NCT00925704|P3|Participant Flow|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
289366|NCT00925704|P2|Participant Flow|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
289367|NCT00925704|P1|Participant Flow|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
289368|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the median of Tmax Sevelamer carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
289369|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the median of Tmax Lanthanum carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
289370|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of Cmax Sevelamer carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
289371|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of Cmax Lanthanum carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
289372|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of AUC 0-48 Sevelamer carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
289373|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of AUC 0-48 Lanthanum carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
289374|NCT00925704|E3|Reported Event|Calcitriol Alone|Calcitriol (1.0 microgram) single dose at lunch
289375|NCT00925704|E2|Reported Event|Sevelamer Carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
289376|NCT00925704|E1|Reported Event|Lanthanum Carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
289377|NCT00925587|B3|Baseline|Total|Total of all reporting groups
289378|NCT00925587|B2|Baseline|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289379|NCT00925587|B1|Baseline|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289380|NCT00925587|P2|Participant Flow|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289381|NCT00925587|P1|Participant Flow|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289382|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289383|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289384|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289385|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289386|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289387|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289388|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289389|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289390|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289391|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289392|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289393|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289394|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289395|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289396|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289397|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289398|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289399|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289400|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289401|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289402|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289403|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289404|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289411|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289412|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289413|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289414|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289415|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289416|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289417|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289418|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289419|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289420|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289421|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289422|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289423|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289424|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289425|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289426|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289427|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289428|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289429|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289430|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289431|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289432|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289433|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289434|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289435|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289436|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289437|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289438|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289439|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289440|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289441|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289442|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289443|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289444|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289445|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289446|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289447|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289448|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289449|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289450|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289451|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289452|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289453|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289454|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289455|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289456|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289457|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289458|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289459|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289460|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289461|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289462|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289463|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289464|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289465|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289466|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289467|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289468|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289469|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289470|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289471|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289472|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289473|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289474|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289475|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289978|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289476|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289477|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289478|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289479|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289480|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289481|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289482|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289483|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289484|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289485|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289486|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289487|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289488|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289489|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289490|NCT00925587|E2|Reported Event|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
289491|NCT00925587|E1|Reported Event|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
289492|NCT00925548|B3|Baseline|Total|Total of all reporting groups
289493|NCT00925548|B2|Baseline|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289494|NCT00925548|B1|Baseline|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289495|NCT00925548|P2|Participant Flow|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289496|NCT00925548|P1|Participant Flow|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289497|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289498|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289499|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289550|NCT00924833|B3|Baseline|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289551|NCT00924833|B2|Baseline|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289552|NCT00924833|B1|Baseline|Placebo|Placebo tablets. One tablet twice daily.
289553|NCT00924833|P3|Participant Flow|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289979|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289500|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289501|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289502|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289503|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289504|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289505|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289506|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289507|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289508|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289509|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289554|NCT00924833|P2|Participant Flow|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289555|NCT00924833|P1|Participant Flow|Placebo|Placebo tablets. One tablet twice daily.
289510|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289511|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289512|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289513|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289514|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289515|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289516|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289517|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289518|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289519|NCT00925548|E2|Reported Event|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
289556|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289557|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289520|NCT00925548|E1|Reported Event|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
289521|NCT00925522|B1|Baseline|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids."
289522|NCT00925522|P1|Participant Flow|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the cat"
289523|NCT00925522|O1|Outcome|Therapy Cool Path Duo Catheter|All patients received RF (radio frequency) therapy from ablation catheter.
289524|NCT00925522|E1|Reported Event|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the catheter in the hospital environment."
289525|NCT00925353|B1|Baseline|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
289526|NCT00925353|P1|Participant Flow|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
289527|NCT00925353|O1|Outcome|Lidocaine Gel Group|Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
289528|NCT00925353|E1|Reported Event|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
289529|NCT00925288|B3|Baseline|Total|Total of all reporting groups
289530|NCT00925288|B2|Baseline|Modified Schedule|Duration: 0,3,6 months
289531|NCT00925288|B1|Baseline|Regular Schedule|Duration: 0,2,6 months
289532|NCT00925288|P2|Participant Flow|Modified Schedule|Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
289533|NCT00925288|P1|Participant Flow|Regular Schedule|Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
289534|NCT00925288|O2|Outcome|Modified Schedule|Participants in 0,3,6 month study arm
289535|NCT00925288|O1|Outcome|Regular Schedule|Participants in 0,2,6 month study arm
289536|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
289537|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
289538|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
289539|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
289540|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
289541|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
289542|NCT00925288|E2|Reported Event|Modified Schedule|Duration: 0,3,6 months
289543|NCT00925288|E1|Reported Event|Regular Schedule|Duration: 0,2,6 months
289544|NCT00924950|B1|Baseline|Ointment + Patch vs. Ointment Alone|
289545|NCT00924950|P1|Participant Flow|Ointment + Patch vs. Ointment Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
289546|NCT00924950|O2|Outcome|Taclonex Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
289547|NCT00924950|O1|Outcome|Taclonex Ointment Occluded With Hydrogel Patch|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
289548|NCT00924950|E1|Reported Event|Ointment + Patch vs. Ointment Alone|
289549|NCT00924833|B4|Baseline|Total|Total of all reporting groups
289558|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
289559|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289560|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289561|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
289562|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289563|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289564|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
289565|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
289566|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
289567|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
289568|NCT00924807|B1|Baseline|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
289569|NCT00924807|P1|Participant Flow|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
289570|NCT00924807|O1|Outcome|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
289571|NCT00924807|E1|Reported Event|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
289572|NCT00924781|B5|Baseline|Total|Total of all reporting groups
289573|NCT00924781|B4|Baseline|MK2578 1mcg/350U QM|MK2578 IV administered QM.
289574|NCT00924781|B3|Baseline|MK2578 1mcg/350U QW|MK2578 IV administered QW.
289575|NCT00924781|B2|Baseline|MK2578 1mcg/600U QM|MK2578 IV administered QM.
289576|NCT00924781|B1|Baseline|MK2578 1mcg/600U QW|MK2578 IV administered QW.
289577|NCT00924781|P2|Participant Flow|MK2578 1mcg/600 U or 1 mg/350 U QM|MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
289578|NCT00924781|P1|Participant Flow|MK2578 1mcg/600 U or 1 mcg/350 U QW|MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
289579|NCT00924781|O4|Outcome|MK-2578 1mcg/350U QM|MK2578 IV was administered QM. Participatns were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alpha) received per 4 weeks at Baseline.
289580|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
289581|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
289582|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK3578 IV was administered QW. Participants were randomized to receive 1 mcg of MK-2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289583|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289584|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289585|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289586|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289587|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289588|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every U of Epogen (epoetin alpha) received per week at Baseline.
289589|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289590|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289591|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM.Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289592|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289593|NCT00924781|O2|Outcome|MK2578 1mcg/600 QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289594|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289595|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289596|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289628|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289597|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289598|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289599|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289600|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289601|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289602|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289603|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289604|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
289605|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
289606|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
289607|NCT00924781|E2|Reported Event|MK2578 QM|MK2578 IV administered once every 4 weeks.
289608|NCT00924781|E1|Reported Event|MK2578 QW|MK2578 IV administered once weekly.
289609|NCT00924729|B3|Baseline|Total|Total of all reporting groups
289610|NCT00924729|B2|Baseline|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289611|NCT00924729|B1|Baseline|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289612|NCT00924729|P2|Participant Flow|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289613|NCT00924729|P1|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289614|NCT00924729|O2|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289615|NCT00924729|O1|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289616|NCT00924729|E2|Reported Event|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289617|NCT00924729|E1|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
289618|NCT00924638|B3|Baseline|Total|Total of all reporting groups
289619|NCT00924638|B2|Baseline|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289620|NCT00924638|B1|Baseline|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289621|NCT00924638|P2|Participant Flow|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289622|NCT00924638|P1|Participant Flow|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289623|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289624|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289625|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289626|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289627|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289778|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289629|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289630|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289631|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289632|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289633|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289634|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289635|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289636|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289637|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289638|NCT00924638|E2|Reported Event|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
289639|NCT00924638|E1|Reported Event|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
289640|NCT00924560|B4|Baseline|Total|Total of all reporting groups
289641|NCT00924560|B3|Baseline|Untreated Control|Participants received no oral contraceptives during the study.
289642|NCT00924560|B2|Baseline|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289643|NCT00924560|B1|Baseline|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289644|NCT00924560|P3|Participant Flow|Untreated Control|Participants received no oral contraceptives during the study.
289645|NCT00924560|P2|Participant Flow|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289646|NCT00924560|P1|Participant Flow|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289647|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289648|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289649|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289650|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289651|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289652|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289653|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289654|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289655|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289656|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289657|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289779|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289780|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289658|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289659|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289660|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289661|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289662|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289663|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289664|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289665|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289666|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289667|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289668|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289669|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289670|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289671|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289672|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289673|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289674|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289675|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289676|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289677|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289678|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289679|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289680|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289681|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289682|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289683|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
289684|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289685|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289686|NCT00924560|E3|Reported Event|Untreated Control|Participants received no oral contraceptives during the study.
289687|NCT00924560|E2|Reported Event|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
289688|NCT00924560|E1|Reported Event|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
289689|NCT00924508|B1|Baseline|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
289690|NCT00924508|P1|Participant Flow|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
289691|NCT00924508|O1|Outcome|Hydrogel Patch Alone, TAC 0.1%, TAC + Patch|"This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.~occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone"
289692|NCT00924508|O3|Outcome|Patch + TAC|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
289693|NCT00924508|O2|Outcome|TAC 0.1%|Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
289694|NCT00924508|O1|Outcome|Hydrogel Patch|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
289695|NCT00924508|E1|Reported Event|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
289696|NCT00924482|B1|Baseline|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
289697|NCT00924482|P1|Participant Flow|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
289698|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
289699|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
289700|NCT00924482|E1|Reported Event|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
289701|NCT00924469|B3|Baseline|Total|Total of all reporting groups
289702|NCT00924469|B2|Baseline|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289703|NCT00924469|B1|Baseline|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289704|NCT00924469|P2|Participant Flow|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289705|NCT00924469|P1|Participant Flow|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289706|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289707|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289708|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289709|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289710|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289711|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289712|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289713|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289714|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289715|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289716|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289717|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289718|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289719|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289781|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289782|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289720|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289721|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289722|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289723|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289724|NCT00924469|E2|Reported Event|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
289725|NCT00924469|E1|Reported Event|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
289726|NCT00924443|B1|Baseline|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289727|NCT00924443|P1|Participant Flow|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
289728|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289729|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289730|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289731|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289732|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
289733|NCT00924443|E1|Reported Event|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
289734|NCT00924352|B1|Baseline|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289735|NCT00924352|P2|Participant Flow|Phase II|The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
289736|NCT00924352|P1|Participant Flow|Phase I|The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
289768|NCT00924066|E1|Reported Event|Adverse Events for Squamous and Non-squamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
289737|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289738|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289739|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289740|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289741|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289742|NCT00924352|O3|Outcome|Ixabepilone + Dasatinib (Dose Level 2)|Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
289743|NCT00924352|O2|Outcome|Ixabepilone + Dasatinib (Dose Level 1)|Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
289744|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib (Dose Level 0)|Dasatinib 100 mg daily and Ixabepilone 16 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
289745|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289746|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289769|NCT00924053|B5|Baseline|Total|Total of all reporting groups
289770|NCT00924053|B4|Baseline|EGT0001474 150mg|Received six 25 mg capsules once daily.
289771|NCT00924053|B3|Baseline|EGT0001474 75 mg|Received three 25mg capsules once daily.
289772|NCT00924053|B2|Baseline|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289773|NCT00924053|B1|Baseline|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289747|NCT00924352|E1|Reported Event|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
289748|NCT00924313|B1|Baseline|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
289749|NCT00924313|P1|Participant Flow|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
289750|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
289751|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
289752|NCT00924313|E1|Reported Event|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
289753|NCT00924287|B1|Baseline|Metastatic Cancer|Cancer that has invaded other parts of the body
289754|NCT00924287|P1|Participant Flow|Metastatic Cancer|Cancer that has invaded other parts of the body
289755|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
289756|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
289757|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
289758|NCT00924287|E1|Reported Event|Metastatic Cancer|Cancer that has invaded other parts of the body
289759|NCT00924209|B1|Baseline|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
289760|NCT00924209|P1|Participant Flow|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
289761|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
289762|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
289763|NCT00924209|E1|Reported Event|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
289764|NCT00924066|B1|Baseline|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
289765|NCT00924066|P1|Participant Flow|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
289766|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
289767|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
289774|NCT00924053|P4|Participant Flow|EGT0001474 150mg|Received six 25 mg capsules once daily.
289775|NCT00924053|P3|Participant Flow|EGT0001474 75 mg|Received three 25mg capsules once daily.
289776|NCT00924053|P2|Participant Flow|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289777|NCT00924053|P1|Participant Flow|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289783|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289784|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289785|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289786|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289787|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289788|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289789|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289790|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289791|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289792|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289793|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289794|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289795|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289796|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289797|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289798|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289799|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289800|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289801|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289802|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289803|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289804|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289805|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289806|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289807|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289808|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289809|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289810|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289811|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289812|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289813|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289814|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
289815|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
289816|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289817|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289818|NCT00924053|E4|Reported Event|EGT0001474 150mg|Received six 25 mg capsules once daily.
289819|NCT00924053|E3|Reported Event|EGT0001474 75 mg|Received three 25mg capsules once daily.
289820|NCT00924053|E2|Reported Event|EGT0001474 25 mg|Received one 25 mg capsule once daily.
289821|NCT00924053|E1|Reported Event|Placebo|Received 1, 3, or 6 placebo capsules once daily.
289822|NCT00924040|B1|Baseline|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289823|NCT00924040|P1|Participant Flow|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289824|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289825|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289826|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289827|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289828|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289829|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289830|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289831|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289832|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289833|NCT00924040|E1|Reported Event|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
289834|NCT00924001|B1|Baseline|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289835|NCT00924001|P1|Participant Flow|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289880|NCT00923351|B3|Baseline|Total|Total of all reporting groups
289836|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289837|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289838|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289839|NCT00924001|E1|Reported Event|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
289840|NCT00923975|B1|Baseline|Intended Users of the Software|Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
289841|NCT00923975|P1|Participant Flow|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289842|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289843|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289844|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289845|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289846|NCT00923975|E1|Reported Event|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
289847|NCT00923949|B1|Baseline|Pioglitazone|45 mg tablet daily by mouth for six weeks
289848|NCT00923949|P1|Participant Flow|Pioglitazone|45 mg tablet daily by mouth for six weeks
289849|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289850|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289851|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289852|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289853|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289854|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289855|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
289856|NCT00923949|E1|Reported Event|Pioglitazone|45 mg tablet daily by mouth for six weeks
289857|NCT00923910|B3|Baseline|Total|Total of all reporting groups
289858|NCT00923910|B2|Baseline|Recipients|Vaccine and donor lymphocyte prep
289859|NCT00923910|B1|Baseline|Donors|Donor lymphocyte collection via apheresis.
289860|NCT00923910|P2|Participant Flow|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
289861|NCT00923910|P1|Participant Flow|Donors|Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
289862|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
289863|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
289864|NCT00923910|E1|Reported Event|Recipients|Vaccine and donor lymphocyte prep
289865|NCT00923845|B3|Baseline|Total|Total of all reporting groups
289866|NCT00923845|B2|Baseline|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
289867|NCT00923845|B1|Baseline|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
289868|NCT00923845|P2|Participant Flow|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
289869|NCT00923845|P1|Participant Flow|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
289870|NCT00923845|O2|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
289871|NCT00923845|O1|Outcome|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
289872|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
289873|NCT00923845|E2|Reported Event|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
289874|NCT00923845|E1|Reported Event|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
289875|NCT00923481|B1|Baseline|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
289876|NCT00923481|P1|Participant Flow|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
289877|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
289878|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
289879|NCT00923481|E1|Reported Event|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
289881|NCT00923351|B2|Baseline|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
289882|NCT00923351|B1|Baseline|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
289883|NCT00923351|P3|Participant Flow|Enrolled But Not Assigned to Treatment|Twelve participants were not treated in Arm A or Arm B because they did not get far enough in the study to be designated for an Arm. Were unable to obtain apheresis, and adequate tumor samples.
289884|NCT00923351|P2|Participant Flow|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose subcutaneous (SQ) (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
289885|NCT00923351|P1|Participant Flow|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participant will receive Tumor lysate/keyhole limpet hemocyanin (KLH) pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
289886|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
289887|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
289888|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
289889|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
289890|NCT00923351|E2|Reported Event|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
289948|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289949|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289950|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289891|NCT00923351|E1|Reported Event|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
289892|NCT00923273|B6|Baseline|Total|Total of all reporting groups
289893|NCT00923273|B5|Baseline|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
289894|NCT00923273|B4|Baseline|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
289895|NCT00923273|B3|Baseline|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
289896|NCT00923273|B2|Baseline|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
289897|NCT00923273|B1|Baseline|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
289898|NCT00923273|P5|Participant Flow|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
289899|NCT00923273|P4|Participant Flow|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
289900|NCT00923273|P3|Participant Flow|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
289901|NCT00923273|P2|Participant Flow|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
289902|NCT00923273|P1|Participant Flow|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
289903|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289904|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289905|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289906|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
289907|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
289908|NCT00923273|O1|Outcome|Treatment Level 4: 10mg Load|"Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2~Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I"
289909|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
289910|NCT00923273|O4|Outcome|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
289911|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
289912|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
289913|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
289914|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289915|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289916|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
289917|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
289918|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
289919|NCT00923273|E5|Reported Event|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
289920|NCT00923273|E4|Reported Event|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
289921|NCT00923273|E3|Reported Event|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
289922|NCT00923273|E2|Reported Event|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
289923|NCT00923273|E1|Reported Event|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
289924|NCT00923260|B3|Baseline|Total|Total of all reporting groups
289925|NCT00923260|B2|Baseline|Roux-en-Y Gastric Bypass Alone|
289926|NCT00923260|B1|Baseline|Roux-en-Y Gastric Bypass/Omentectomy|
289927|NCT00923260|P2|Participant Flow|Roux-en-Y Gastric Bypass Alone|
289928|NCT00923260|P1|Participant Flow|Roux-en-Y Gastric Bypass/Omentectomy|
289929|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289930|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289931|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289932|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289933|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289934|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289935|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289936|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289937|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289938|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289939|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289940|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289941|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289942|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289943|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289944|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289945|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289946|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289947|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289980|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289981|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289982|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289983|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289984|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289985|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289986|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289987|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289988|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289989|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289990|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289991|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289992|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289993|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289994|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289995|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289996|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289997|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
289998|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
289999|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290000|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290001|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290002|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290003|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290004|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290005|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290006|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290007|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290008|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290009|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290010|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290011|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290012|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290013|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290014|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290015|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290016|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290017|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290018|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290019|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290020|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290021|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290022|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290023|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290024|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290025|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290026|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290027|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290028|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290029|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290030|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290031|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290032|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290033|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290034|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290035|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290036|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290037|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290038|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290039|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290040|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290041|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290042|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290043|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290044|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290045|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290046|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290047|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290048|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290049|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290050|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290051|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290052|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290053|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290054|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290055|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
290056|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
290057|NCT00923260|E2|Reported Event|Roux-en-Y Gastric Bypass Alone|
290058|NCT00923260|E1|Reported Event|Roux-en-Y Gastric Bypass/Omentectomy|
290059|NCT00923195|B3|Baseline|Total|Total of all reporting groups
290128|NCT00923091|P6|Participant Flow|Olmesartan(OM)20mg/Amlodipine (AML)5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290787|NCT00920647|O1|Outcome|Control|Untreated Patients
290060|NCT00923195|B2|Baseline|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290061|NCT00923195|B1|Baseline|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290062|NCT00923195|P2|Participant Flow|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290063|NCT00923195|P1|Participant Flow|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290064|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290065|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290066|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290067|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290068|NCT00923195|E2|Reported Event|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290069|NCT00923195|E1|Reported Event|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
290070|NCT00923156|B4|Baseline|Total|Total of all reporting groups
290071|NCT00923156|B3|Baseline|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290072|NCT00923156|B2|Baseline|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290073|NCT00923156|B1|Baseline|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290074|NCT00923156|P3|Participant Flow|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290075|NCT00923156|P2|Participant Flow|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290076|NCT00923156|P1|Participant Flow|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290077|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290078|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290079|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290080|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290081|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290412|NCT00922428|O2|Outcome|Observational Group (Visit 2)|VAS of the observational group at visit 2
290082|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290083|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290084|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290085|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290086|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290087|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290088|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290089|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290090|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290091|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290092|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290093|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290094|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290095|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290096|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290129|NCT00923091|P5|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290097|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290098|NCT00923156|E3|Reported Event|Ramipril + Aliskiren|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
290099|NCT00923156|E2|Reported Event|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
290100|NCT00923156|E1|Reported Event|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
290101|NCT00923117|B3|Baseline|Total|Total of all reporting groups
290102|NCT00923117|B2|Baseline|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
290103|NCT00923117|B1|Baseline|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
290104|NCT00923117|P2|Participant Flow|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
290105|NCT00923117|P1|Participant Flow|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
290106|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
290107|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
290108|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
290109|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
290110|NCT00923117|E2|Reported Event|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
290111|NCT00923117|E1|Reported Event|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
290112|NCT00923091|B9|Baseline|Total|Total of all reporting groups
290113|NCT00923091|B8|Baseline|Olmesartan/Amlodipine 40mg/10mg|
290114|NCT00923091|B7|Baseline|Olmesartan/Amlodipine 40mg/5mg|
290115|NCT00923091|B6|Baseline|Olmesartan/Amlodipine 20mg/5mg|
290116|NCT00923091|B5|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
290117|NCT00923091|B4|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
290118|NCT00923091|B3|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
290119|NCT00923091|B2|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
290120|NCT00923091|B1|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
290121|NCT00923091|P13|Participant Flow|20/5/12.5mg Responder Continued on 20/5/12.5 mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
290122|NCT00923091|P12|Participant Flow|OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
290123|NCT00923091|P11|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
290124|NCT00923091|P10|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
290125|NCT00923091|P9|Participant Flow|OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg|In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
290126|NCT00923091|P8|Participant Flow|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290127|NCT00923091|P7|Participant Flow|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290148|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290846|NCT00920309|O2|Outcome|Standard of Care-Placebo|
290130|NCT00923091|P4|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290131|NCT00923091|P3|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
290132|NCT00923091|P2|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group.
290133|NCT00923091|P1|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group.
290134|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25|The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
290135|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
290136|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
290137|NCT00923091|O2|Outcome|OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
290138|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
290139|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
290140|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
290141|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290142|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290143|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290144|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290145|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.~Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290146|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
290147|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290149|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290150|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
290151|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290152|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
290153|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290154|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290155|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290156|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290157|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290158|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
290159|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290160|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
290161|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290162|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290163|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290164|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290165|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
290166|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
290167|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290168|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
290169|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290170|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
290171|NCT00923091|E8|Reported Event|Olmesartan/Amlodipine 40mg/10mg|
290172|NCT00923091|E7|Reported Event|Olmesartan/Amlodipine 40mg/5mg|
290173|NCT00923091|E6|Reported Event|Olmesartan/Amlodipine 20mg/5mg|
290174|NCT00923091|E5|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
290175|NCT00923091|E4|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
290176|NCT00923091|E3|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
290177|NCT00923091|E2|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
290178|NCT00923091|E1|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
290179|NCT00922987|B1|Baseline|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290180|NCT00922987|P1|Participant Flow|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290181|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290182|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290183|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290184|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290914|NCT00919932|B3|Baseline|Total|Total of all reporting groups
290185|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290186|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290187|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290188|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290189|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290190|NCT00922987|E1|Reported Event|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
290191|NCT00922935|B4|Baseline|Total|Total of all reporting groups
290192|NCT00922935|B3|Baseline|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
290193|NCT00922935|B2|Baseline|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
290194|NCT00922935|B1|Baseline|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
290195|NCT00922935|P3|Participant Flow|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
290196|NCT00922935|P2|Participant Flow|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
290197|NCT00922935|P1|Participant Flow|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
290198|NCT00922935|O3|Outcome|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
290199|NCT00922935|O2|Outcome|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
290200|NCT00922935|O1|Outcome|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
290201|NCT00922935|E3|Reported Event|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
290202|NCT00922935|E2|Reported Event|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
290203|NCT00922935|E1|Reported Event|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
290204|NCT00922779|B1|Baseline|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290205|NCT00922779|P1|Participant Flow|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290206|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290207|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290208|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
291007|NCT00919711|E1|Reported Event|Risedronate 150 mg QM|
290209|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290210|NCT00922779|E1|Reported Event|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
290211|NCT00922766|B1|Baseline|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290212|NCT00922766|P1|Participant Flow|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290213|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290214|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290215|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290216|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290217|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290218|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290219|NCT00922766|E1|Reported Event|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
290220|NCT00922701|B1|Baseline|Peritoneal Dialysis Solution|The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
290221|NCT00922701|P1|Participant Flow|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
290222|NCT00922701|O1|Outcome|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
290223|NCT00922701|E1|Reported Event|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
290224|NCT00922636|B6|Baseline|Total|Total of all reporting groups
290225|NCT00922636|B5|Baseline|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290226|NCT00922636|B4|Baseline|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290227|NCT00922636|B3|Baseline|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290228|NCT00922636|B2|Baseline|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290229|NCT00922636|B1|Baseline|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290230|NCT00922636|P5|Participant Flow|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290231|NCT00922636|P4|Participant Flow|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290232|NCT00922636|P3|Participant Flow|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290233|NCT00922636|P2|Participant Flow|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290234|NCT00922636|P1|Participant Flow|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290235|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290236|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290237|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290238|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290239|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290240|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290241|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290242|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290243|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290244|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290245|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290246|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290247|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290248|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290249|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290250|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290251|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290252|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290253|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290254|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290277|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
291008|NCT00919633|B5|Baseline|Total|Total of all reporting groups
290255|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290256|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290257|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290258|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290259|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290260|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290261|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290262|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290263|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290264|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290265|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290266|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290267|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290268|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290269|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290270|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290271|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290272|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290273|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290274|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290275|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290276|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
291090|NCT00919113|B2|Baseline|Placebo|identical buffer
290278|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290279|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290280|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290281|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290282|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290283|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290284|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290285|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290286|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290287|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290288|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290289|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290290|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290291|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290292|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290293|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290294|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290295|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290296|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290297|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290298|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290299|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290409|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
290300|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290301|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290302|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290303|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290304|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290305|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290306|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290307|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290308|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290309|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290310|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290311|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290312|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290313|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290314|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290315|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290316|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290317|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290318|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290319|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290320|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290321|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290322|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290323|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290324|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290325|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290326|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290327|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290328|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290329|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290330|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290331|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290332|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290333|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290334|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290335|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290336|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290337|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290338|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290339|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290340|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290341|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290342|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290343|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290413|NCT00922428|O1|Outcome|Observational (Visit 1)|VAS of the observational group at beginning
290344|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290345|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290346|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290347|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290348|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290349|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290350|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290351|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290352|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290353|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290354|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290355|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290356|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290357|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290358|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290359|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290360|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290361|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
290362|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290363|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290364|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290365|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290410|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
290366|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290367|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290368|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290369|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
290370|NCT00922636|E10|Reported Event|Methylphenidate - Taper Phase|Participants were given the placebo in capsule form QD po for the 2-week taper phase.
290371|NCT00922636|E9|Reported Event|LY2216684 (0.3 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
290372|NCT00922636|E8|Reported Event|LY2216684 (0.2 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase.
290373|NCT00922636|E7|Reported Event|LY2216684 (0.1 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
290374|NCT00922636|E6|Reported Event|Placebo - Taper Phase|Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase.
290375|NCT00922636|E5|Reported Event|Methylphenidate - Treatment Phase|Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding.
290376|NCT00922636|E4|Reported Event|LY2216684 (0.3 mg/kg/Day) - Treatment Phase|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290377|NCT00922636|E3|Reported Event|LY2216684 (0.2 mg/kg/Day) - Treatment Phase|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290378|NCT00922636|E2|Reported Event|LY2216684 (0.1 mg/kg/Day) - Treatment Phase|Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
290379|NCT00922636|E1|Reported Event|Placebo - Treatment Phase|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase.
290380|NCT00922623|B1|Baseline|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
290381|NCT00922623|P1|Participant Flow|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
290382|NCT00922623|O2|Outcome|Belotero, Right Nasolabial Fold|Belotero injected into the Right Nasolabial Fold of the Face
290383|NCT00922623|O1|Outcome|Belotero, Left Nasolabial Fold|Belotero injected into the Left Nasolabial Fold of the Face
290384|NCT00922623|E2|Reported Event|Belotero, Right Nasolabial Fold|
290385|NCT00922623|E1|Reported Event|Belotero, Left Nasolabial Fold|
290386|NCT00922428|B1|Baseline|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
290387|NCT00922428|P1|Participant Flow|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
290388|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290389|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290390|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290391|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290392|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290393|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290394|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290395|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290396|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290397|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290398|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290399|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290400|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290401|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290402|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290403|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290404|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290405|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290406|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
290407|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
290408|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
290411|NCT00922428|O3|Outcome|Observational Group (Visit 3)|VAS of the observational group at visit 3
290414|NCT00922428|E1|Reported Event|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
290415|NCT00922272|B1|Baseline|Overall|Constitutes all subjects contained in the Safety Analysis Set defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.
290416|NCT00922272|P2|Participant Flow|Placebo|Subjects received placebo once-daily for 4 weeks during the Double-blind Phase to a stable dose of atypical antipsychotic medication.
290417|NCT00922272|P1|Participant Flow|SPD489|The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication. They were then randomized into the Double-Blind Phase receiving either their optimal dose of adjunctive SPD489 or placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290418|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290419|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290420|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290421|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290422|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290423|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290424|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290425|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290426|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290427|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290428|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290429|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290430|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290431|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290432|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290433|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290434|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290435|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290436|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290437|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290438|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290439|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290440|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290441|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290442|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290443|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290444|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290445|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290446|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290447|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290448|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290449|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290450|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290451|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290452|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290453|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290454|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290455|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290456|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290457|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290458|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290459|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290460|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290461|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290462|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290463|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290464|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290465|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290466|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
290467|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290468|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
290469|NCT00922272|E3|Reported Event|Placebo (Double-blind Phase)|Subjects receive placebo once-daily
290470|NCT00922272|E2|Reported Event|SPD489 (Double-blind Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
290471|NCT00922272|E1|Reported Event|SPD489 (Open-label Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
290472|NCT00922233|B1|Baseline|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
290518|NCT00922194|E1|Reported Event|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290473|NCT00922233|P1|Participant Flow|Levonorgestrel|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
290474|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
290475|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
290476|NCT00922233|O1|Outcome|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills
290477|NCT00922233|E1|Reported Event|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
290478|NCT00922207|B4|Baseline|Total|Total of all reporting groups
290479|NCT00922207|B3|Baseline|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290480|NCT00922207|B2|Baseline|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290481|NCT00922207|B1|Baseline|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290482|NCT00922207|P3|Participant Flow|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290483|NCT00922207|P2|Participant Flow|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290484|NCT00922207|P1|Participant Flow|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290485|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290486|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290487|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290488|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290489|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290490|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290491|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290492|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290493|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290786|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290494|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290495|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290496|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290497|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290498|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290499|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290500|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290501|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290502|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290503|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290504|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290505|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290506|NCT00922207|E3|Reported Event|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290507|NCT00922207|E2|Reported Event|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290508|NCT00922207|E1|Reported Event|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
290509|NCT00922194|B1|Baseline|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290510|NCT00922194|P1|Participant Flow|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290511|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290512|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290513|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290514|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290515|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290516|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290517|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
290519|NCT00922116|B1|Baseline|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290520|NCT00922116|P1|Participant Flow|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290521|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290522|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290523|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290524|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290525|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290526|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290527|NCT00922116|E1|Reported Event|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
290528|NCT00921947|B3|Baseline|Total|Total of all reporting groups
290529|NCT00921947|B2|Baseline|VAX102 SC|Given as 2 µg subcutaneous
290530|NCT00921947|B1|Baseline|VAX102 IM|Given as 1 µg intramuscular
290531|NCT00921947|P2|Participant Flow|VAX102 SC|Given as 2 µg subcutaneous
290532|NCT00921947|P1|Participant Flow|VAX102 IM|Given as 1 µg intramuscular
290533|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
290534|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
290535|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
290536|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
290537|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
290538|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
290539|NCT00921947|E2|Reported Event|VAX102 SC|Given as 2 µg subcutaneous
290540|NCT00921947|E1|Reported Event|VAX102 IM|Given as 1 µg intramuscular
290541|NCT00921934|B1|Baseline|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
290542|NCT00921934|P1|Participant Flow|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
290543|NCT00921934|O1|Outcome|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
290544|NCT00921934|E1|Reported Event|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
290545|NCT00921895|B1|Baseline|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
290546|NCT00921895|P1|Participant Flow|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
290547|NCT00921895|O2|Outcome|RPS Adeno Detector IV (Specificity)|Looking for the number of true negatives as compared to cell culture.
290548|NCT00921895|O1|Outcome|RPS Adeno Detector IV (Sensitivity)|Looking for the number of true positives as compared to cell culture.
290549|NCT00921895|E1|Reported Event|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
290550|NCT00921687|B3|Baseline|Total|Total of all reporting groups
290551|NCT00921687|B2|Baseline|Intervention Clinic|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
290552|NCT00921687|B1|Baseline|Control Clinic|Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).
290553|NCT00921687|P2|Participant Flow|Intervention|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
290554|NCT00921687|P1|Participant Flow|Control|Providers in the control group received education only (CKD lecture and a CKD reference card).
290555|NCT00921687|O2|Outcome|Intervention Clinic|
290556|NCT00921687|O1|Outcome|Control Clinic|
290557|NCT00921687|O2|Outcome|Intervention Clinic|
290558|NCT00921687|O1|Outcome|Control Clinic|
290559|NCT00921687|E2|Reported Event|Intervention Clinic|
290560|NCT00921687|E1|Reported Event|Control Clinic|
290561|NCT00921518|B3|Baseline|Total|Total of all reporting groups
290579|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290562|NCT00921518|B2|Baseline|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290563|NCT00921518|B1|Baseline|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290564|NCT00921518|P2|Participant Flow|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290565|NCT00921518|P1|Participant Flow|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290566|NCT00921518|O2|Outcome|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290567|NCT00921518|O1|Outcome|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290568|NCT00921518|E2|Reported Event|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290569|NCT00921518|E1|Reported Event|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
290570|NCT00921310|B3|Baseline|Total|Total of all reporting groups
290571|NCT00921310|B2|Baseline|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290572|NCT00921310|B1|Baseline|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290573|NCT00921310|P3|Participant Flow|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290574|NCT00921310|P2|Participant Flow|Phase I Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290575|NCT00921310|P1|Participant Flow|Phase I Dose Level 1 (Pemetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290576|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290577|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290578|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290580|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290581|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290582|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290583|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290584|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290585|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290586|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290587|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290588|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290589|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290590|NCT00921310|O3|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290591|NCT00921310|O2|Outcome|Phase 1 Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290592|NCT00921310|O1|Outcome|Phase I Dose Level 1 (Premetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290593|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290594|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290595|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290596|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290597|NCT00921310|E2|Reported Event|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
290598|NCT00921310|E1|Reported Event|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
290599|NCT00921024|B3|Baseline|Total|Total of all reporting groups
290600|NCT00921024|B2|Baseline|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
290601|NCT00921024|B1|Baseline|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
290602|NCT00921024|P2|Participant Flow|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
290603|NCT00921024|P1|Participant Flow|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
290604|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
290605|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
290606|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
290607|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
290608|NCT00921024|E2|Reported Event|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
290609|NCT00921024|E1|Reported Event|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
290610|NCT00920907|B3|Baseline|Total|Total of all reporting groups
290611|NCT00920907|B2|Baseline|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290612|NCT00920907|B1|Baseline|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290631|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290613|NCT00920907|P2|Participant Flow|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290614|NCT00920907|P1|Participant Flow|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
290615|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290616|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290617|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290618|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290619|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290620|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290621|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290622|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290623|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290624|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290625|NCT00920907|O2|Outcome|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290626|NCT00920907|O1|Outcome|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
290627|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290628|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290629|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290630|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290632|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290633|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290634|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290635|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290636|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290637|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290638|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290639|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290640|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290641|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290642|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290643|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290644|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290645|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290646|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290647|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290648|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290649|NCT00920907|E2|Reported Event|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
290650|NCT00920907|E1|Reported Event|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
290651|NCT00920855|B4|Baseline|Total|Total of all reporting groups
290652|NCT00920855|B3|Baseline|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290653|NCT00920855|B2|Baseline|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290783|NCT00920647|O1|Outcome|Control|Untreated Patients
290654|NCT00920855|B1|Baseline|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290655|NCT00920855|P3|Participant Flow|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290656|NCT00920855|P2|Participant Flow|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290657|NCT00920855|P1|Participant Flow|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290658|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290659|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290660|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290661|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
290662|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
290663|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
290664|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
290665|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
290666|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290667|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290668|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290669|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290670|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290671|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290672|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290673|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290674|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290675|NCT00920855|E3|Reported Event|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290676|NCT00920855|E2|Reported Event|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290677|NCT00920855|E1|Reported Event|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
290678|NCT00920816|B5|Baseline|Total|Total of all reporting groups
290679|NCT00920816|B4|Baseline|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290680|NCT00920816|B3|Baseline|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290681|NCT00920816|B2|Baseline|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290682|NCT00920816|B1|Baseline|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290683|NCT00920816|P4|Participant Flow|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290684|NCT00920816|P3|Participant Flow|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290685|NCT00920816|P2|Participant Flow|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290686|NCT00920816|P1|Participant Flow|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290687|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290688|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290689|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290690|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290691|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290692|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290693|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290694|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290695|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290696|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290697|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290698|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290699|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290700|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290701|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290784|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290702|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290703|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290704|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290705|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290706|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290707|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290708|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290709|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290710|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290711|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290712|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290713|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290714|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290715|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290716|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290717|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290718|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290719|NCT00920816|E4|Reported Event|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290720|NCT00920816|E3|Reported Event|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290721|NCT00920816|E2|Reported Event|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290785|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290722|NCT00920816|E1|Reported Event|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
290723|NCT00920790|B1|Baseline|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290724|NCT00920790|P1|Participant Flow|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290725|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290726|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290727|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290728|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290729|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290730|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290731|NCT00920790|E1|Reported Event|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
290732|NCT00920686|B4|Baseline|Total|Total of all reporting groups
290733|NCT00920686|B3|Baseline|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
290734|NCT00920686|B2|Baseline|NXN-188 600 mg|3 x 200 mg capsules
290735|NCT00920686|B1|Baseline|Placebo|3 x 0 mg capsules
290736|NCT00920686|P3|Participant Flow|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
290737|NCT00920686|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules
290738|NCT00920686|P1|Participant Flow|Placebo|3 x 0 mg capsules
290739|NCT00920686|O3|Outcome|Sumatriptan Succinate|1 x 100 mg, 2 x 0 mg capsules
290740|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
290741|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
290742|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
290743|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
290744|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
290745|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
290746|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
290747|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
290748|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
290749|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
290750|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
290751|NCT00920686|O3|Outcome|Sumatriptan Succinate|100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
290752|NCT00920686|O2|Outcome|NXN-188|600 mg of NXN-188 provided as 3 x 200 mg capsules.
290753|NCT00920686|O1|Outcome|Placebo|Three capsules containing placebo
290754|NCT00920686|E3|Reported Event|Sumatriptan Succinate|100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
290755|NCT00920686|E2|Reported Event|NXN-188|600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
290756|NCT00920686|E1|Reported Event|Placebo|Three placebo capsules were provided. All capsules were taken at the same time.
290757|NCT00920647|B5|Baseline|Total|Total of all reporting groups
290758|NCT00920647|B4|Baseline|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290759|NCT00920647|B3|Baseline|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290760|NCT00920647|B2|Baseline|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290761|NCT00920647|B1|Baseline|Control|Untreated Patients
290762|NCT00920647|P4|Participant Flow|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290763|NCT00920647|P3|Participant Flow|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290764|NCT00920647|P2|Participant Flow|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290765|NCT00920647|P1|Participant Flow|Control|Untreated Patients
290766|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290767|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290768|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290769|NCT00920647|O1|Outcome|Control|Untreated Patients, Observed Value
290770|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration"
290771|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 24 hours post drug administration"
290772|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration."
290773|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290774|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290775|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD.
290776|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290777|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290778|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290779|NCT00920647|O1|Outcome|Control|Untreated Patients
290780|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290781|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290782|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290788|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290789|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290790|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290791|NCT00920647|O1|Outcome|Control|Untreated Patients
290792|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290793|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290794|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290795|NCT00920647|O1|Outcome|Control|
290796|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290797|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290798|NCT00920647|O2|Outcome|Idursulfase IT (1mg)|monthly using an intrathecal drug delivery device (IDDD)
290799|NCT00920647|O1|Outcome|Control|Untreated Patients
290800|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290801|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290802|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290803|NCT00920647|O1|Outcome|Control|Untreated Patients for 6 months, Observed Value
290804|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290805|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290806|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290807|NCT00920647|O1|Outcome|Control|Untreated Patients
290808|NCT00920647|E4|Reported Event|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
290809|NCT00920647|E3|Reported Event|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
290810|NCT00920647|E2|Reported Event|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
290811|NCT00920647|E1|Reported Event|Control|Untreated Patients
290812|NCT00920374|B3|Baseline|Total|Total of all reporting groups
290813|NCT00920374|B2|Baseline|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290814|NCT00920374|B1|Baseline|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290815|NCT00920374|P2|Participant Flow|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290816|NCT00920374|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290817|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290818|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290819|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290820|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290821|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290822|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290823|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290824|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290825|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290826|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290827|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290828|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290829|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290830|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290831|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290832|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290833|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290834|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290835|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290836|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290837|NCT00920374|E2|Reported Event|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
290838|NCT00920374|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
290839|NCT00920309|B3|Baseline|Total|Total of all reporting groups
290840|NCT00920309|B2|Baseline|Standard of Care-Placebo|
290841|NCT00920309|B1|Baseline|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
290842|NCT00920309|P2|Participant Flow|Standard of Care-Placebo|
290843|NCT00920309|P1|Participant Flow|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
290844|NCT00920309|O2|Outcome|Standard of Care-Placebo|
290845|NCT00920309|O1|Outcome|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
290847|NCT00920309|O1|Outcome|Rapamycin|The study was terminated before any enrolled patients were treated for 2 years.
290848|NCT00920309|E2|Reported Event|Standard of Care-Placebo|
290849|NCT00920309|E1|Reported Event|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
290850|NCT00920231|B3|Baseline|Total|Total of all reporting groups
290851|NCT00920231|B2|Baseline|Modified System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
290852|NCT00920231|B1|Baseline|Initial System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
290853|NCT00920231|P2|Participant Flow|Modified Computer Vision System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
290854|NCT00920231|P1|Participant Flow|Initial Computer Vision System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
290855|NCT00920231|O2|Outcome|Modified System|this computer vision system incorporates the needed changes identified by the first group of subjects using the initial prototype system.
290856|NCT00920231|O1|Outcome|Initial Prototype|The initial prototype is a system that has been successfully tested in outdoor navigation and successfully tested for simple object recognition.
290857|NCT00920231|O2|Outcome|Modified System|a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
290858|NCT00920231|O1|Outcome|Initial System|The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
290859|NCT00920231|E2|Reported Event|Arm 2|"The subject without the assist device can only locate the object by groping and random searching with hands.~No adverse events"
290860|NCT00920231|E1|Reported Event|Arm 1|"the blind subject is asked to locate a randomly placed object with the assistance of the webcam/laptop computer.~computer vision: a webcam-laptop based system to assist the blind in locating objects and in way finding.~No adverse events"
290861|NCT00920140|B6|Baseline|Total|Total of all reporting groups
290862|NCT00920140|B5|Baseline|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290863|NCT00920140|B4|Baseline|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
290864|NCT00920140|B3|Baseline|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290865|NCT00920140|B2|Baseline|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290866|NCT00920140|B1|Baseline|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290867|NCT00920140|P5|Participant Flow|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290868|NCT00920140|P4|Participant Flow|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
290869|NCT00920140|P3|Participant Flow|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.
290870|NCT00920140|P2|Participant Flow|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290871|NCT00920140|P1|Participant Flow|GSK1120212 < 2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290872|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290873|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
290874|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290875|NCT00920140|O1|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290876|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290877|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
290878|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
290879|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290880|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
290881|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
290882|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290883|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
290884|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
290885|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290886|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
290887|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
290888|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290889|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
290890|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
290891|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290892|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
290893|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
290894|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290895|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290896|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290897|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290898|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290899|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290900|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290901|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290902|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290903|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290904|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290905|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290906|NCT00920140|E2|Reported Event|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
290907|NCT00920140|E1|Reported Event|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
290908|NCT00920075|B1|Baseline|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290909|NCT00920075|P1|Participant Flow|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290910|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290911|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290912|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290913|NCT00920075|E1|Reported Event|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
290915|NCT00919932|B2|Baseline|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
290916|NCT00919932|B1|Baseline|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
290917|NCT00919932|P2|Participant Flow|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
290918|NCT00919932|P1|Participant Flow|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
290919|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
290920|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
290921|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
290922|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
290923|NCT00919932|E2|Reported Event|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
290924|NCT00919932|E1|Reported Event|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
290925|NCT00919893|B3|Baseline|Total|Total of all reporting groups
290926|NCT00919893|B2|Baseline|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
290927|NCT00919893|B1|Baseline|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
290928|NCT00919893|P2|Participant Flow|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
290929|NCT00919893|P1|Participant Flow|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
290930|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
290931|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
290932|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
290933|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
290934|NCT00919867|B7|Baseline|Total|Total of all reporting groups
290935|NCT00919867|B6|Baseline|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
290936|NCT00919867|B5|Baseline|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
290937|NCT00919867|B4|Baseline|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
290938|NCT00919867|B3|Baseline|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
290939|NCT00919867|B2|Baseline|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
290940|NCT00919867|B1|Baseline|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
290941|NCT00919867|P6|Participant Flow|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
290942|NCT00919867|P5|Participant Flow|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
290943|NCT00919867|P4|Participant Flow|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
290944|NCT00919867|P3|Participant Flow|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
290945|NCT00919867|P2|Participant Flow|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
290946|NCT00919867|P1|Participant Flow|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
290947|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290948|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
290949|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290950|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
290951|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290952|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
290953|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290954|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
290955|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290956|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
290957|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290958|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
290959|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290960|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
290961|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290962|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
290963|NCT00919867|E3|Reported Event|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
290964|NCT00919867|E2|Reported Event|Vyvanse Alone|Single 50 mg dose
290965|NCT00919867|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
290966|NCT00919854|B1|Baseline|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290967|NCT00919854|P1|Participant Flow|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
291085|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291086|NCT00919126|E3|Reported Event|Group C|Medical Air in Oxygen (45%-55%)
290968|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290969|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290970|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290971|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290972|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290973|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290974|NCT00919854|E1|Reported Event|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
290975|NCT00919763|B3|Baseline|Total|Total of all reporting groups
290976|NCT00919763|B2|Baseline|CD 2027 Vehicle, Twice Daily|Topical Ointment
290977|NCT00919763|B1|Baseline|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
290978|NCT00919763|P2|Participant Flow|CD 2027 Vehicle, Twice Daily|Topical Ointment
290979|NCT00919763|P1|Participant Flow|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
290980|NCT00919763|O2|Outcome|CD 2027 Vehicle, Twice Daily|Topical Ointment
290981|NCT00919763|O1|Outcome|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
290982|NCT00919763|E2|Reported Event|CD 2027 Vehicle, Twice Daily|Topical Ointment
290983|NCT00919763|E1|Reported Event|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
290984|NCT00919724|B3|Baseline|Total|Total of all reporting groups
290985|NCT00919724|B2|Baseline|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
290986|NCT00919724|B1|Baseline|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
290987|NCT00919724|P2|Participant Flow|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
290988|NCT00919724|P1|Participant Flow|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
290989|NCT00919724|O2|Outcome|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
290990|NCT00919724|O1|Outcome|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
290991|NCT00919724|E2|Reported Event|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
290992|NCT00919724|E1|Reported Event|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
290993|NCT00919711|B3|Baseline|Total|Total of all reporting groups
290994|NCT00919711|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
290995|NCT00919711|B1|Baseline|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
290996|NCT00919711|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
290997|NCT00919711|P1|Participant Flow|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
290998|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
290999|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
291000|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
291001|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
291002|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
291003|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
291004|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
291005|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
291006|NCT00919711|E2|Reported Event|Denosumab 60 mg Q6M|
291009|NCT00919633|B4|Baseline|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291010|NCT00919633|B3|Baseline|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291011|NCT00919633|B2|Baseline|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291012|NCT00919633|B1|Baseline|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291013|NCT00919633|P4|Participant Flow|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291014|NCT00919633|P3|Participant Flow|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291015|NCT00919633|P2|Participant Flow|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291016|NCT00919633|P1|Participant Flow|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291017|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291018|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291019|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291020|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291021|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291022|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291023|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291024|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291025|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291026|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291027|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291028|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291029|NCT00919633|E4|Reported Event|INTRON A 160,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291087|NCT00919126|E2|Reported Event|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291088|NCT00919126|E1|Reported Event|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291089|NCT00919113|B3|Baseline|Total|Total of all reporting groups
291030|NCT00919633|E3|Reported Event|INTRON A 120,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291031|NCT00919633|E2|Reported Event|INTRON A 80,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291032|NCT00919633|E1|Reported Event|PEGINTRON 1.5|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
291033|NCT00919191|B1|Baseline|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
291034|NCT00919191|P1|Participant Flow|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
291035|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
291036|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split-face model
291037|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
291038|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split face model
291039|NCT00919191|E1|Reported Event|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
291040|NCT00919126|B4|Baseline|Total|Total of all reporting groups
291041|NCT00919126|B3|Baseline|Group C|Medical Air in Oxygen (45%-55%)
291042|NCT00919126|B2|Baseline|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291043|NCT00919126|B1|Baseline|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291044|NCT00919126|P3|Participant Flow|Group C|Medical Air in Oxygen (45%-55%)
291045|NCT00919126|P2|Participant Flow|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291046|NCT00919126|P1|Participant Flow|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291047|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291048|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291049|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291050|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291051|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291052|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291053|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291054|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291055|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291056|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291057|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291058|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291059|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291060|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291061|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291062|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291063|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291064|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291065|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291066|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291067|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291068|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291069|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291070|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291071|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291072|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291073|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291074|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291075|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291076|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291077|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291078|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
291079|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291080|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291081|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
291082|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
291083|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
291084|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
291091|NCT00919113|B1|Baseline|Uracyst|2% sodium chondroitin sulfate
291092|NCT00919113|P2|Participant Flow|Placebo|identical buffer
291093|NCT00919113|P1|Participant Flow|Uracyst|2% sodium chondroitin sulfate
291094|NCT00919113|O2|Outcome|Placebo|identical buffer
291095|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
291096|NCT00919113|O2|Outcome|Placebo|identical buffer
291097|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
291098|NCT00919113|E2|Reported Event|Placebo|"identical buffer~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
291099|NCT00919113|E1|Reported Event|Uracyst|"2% sodium chondroitin sulfate~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
291100|NCT00919061|B1|Baseline|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
291101|NCT00919061|P1|Participant Flow|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
291102|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
291103|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
291104|NCT00919061|E1|Reported Event|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
291105|NCT00919035|B1|Baseline|Torisel|"Single Agent Temsorilmus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291106|NCT00919035|P1|Participant Flow|Torisel|"Single Agent Temsirolimus (Torisel®)~torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291107|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291108|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291109|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291110|NCT00919035|E1|Reported Event|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
291111|NCT00918957|B3|Baseline|Total|Total of all reporting groups
291112|NCT00918957|B2|Baseline|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291113|NCT00918957|B1|Baseline|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291114|NCT00918957|P2|Participant Flow|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291115|NCT00918957|P1|Participant Flow|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291146|NCT00918879|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291116|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291117|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291118|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291119|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291120|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291121|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291122|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291123|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291124|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291125|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291126|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291127|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291128|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291129|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291130|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291131|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291132|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291133|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291134|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291135|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291136|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291137|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291138|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291139|NCT00918957|E2|Reported Event|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
291140|NCT00918957|E1|Reported Event|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
291141|NCT00918931|B1|Baseline|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
291142|NCT00918931|P1|Participant Flow|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
291143|NCT00918931|O1|Outcome|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
291144|NCT00918931|E1|Reported Event|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
291145|NCT00918879|B3|Baseline|Total|Total of all reporting groups
291147|NCT00918879|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291148|NCT00918879|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291149|NCT00918879|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291150|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291151|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291152|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291153|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291154|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291155|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291156|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291157|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291158|NCT00918879|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
291159|NCT00918879|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
291160|NCT00918866|B3|Baseline|Total|Total of all reporting groups
291161|NCT00918866|B2|Baseline|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291162|NCT00918866|B1|Baseline|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291163|NCT00918866|P2|Participant Flow|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291164|NCT00918866|P1|Participant Flow|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291165|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291166|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291167|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291168|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291169|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291170|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291171|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291172|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291173|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291174|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291175|NCT00918866|E2|Reported Event|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
291176|NCT00918866|E1|Reported Event|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
291177|NCT00918749|B4|Baseline|Total|Total of all reporting groups
291178|NCT00918749|B3|Baseline|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291179|NCT00918749|B2|Baseline|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291180|NCT00918749|B1|Baseline|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291181|NCT00918749|P3|Participant Flow|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291182|NCT00918749|P2|Participant Flow|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291183|NCT00918749|P1|Participant Flow|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291184|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291185|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291186|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291187|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291188|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291189|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291190|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291191|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291192|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291193|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291194|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291195|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291196|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291197|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291198|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291199|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291200|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291201|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291202|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291203|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291204|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291205|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291206|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291207|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291208|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291209|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291210|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291211|NCT00918749|E3|Reported Event|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291212|NCT00918749|E2|Reported Event|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
291213|NCT00918749|E1|Reported Event|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
291214|NCT00918736|B1|Baseline|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
291215|NCT00918736|P1|Participant Flow|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
291216|NCT00918736|O1|Outcome|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
291217|NCT00918736|E1|Reported Event|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
291218|NCT00918671|B1|Baseline|Medication-overuse Headache|Chronic daily headache combined with medication overuse
291219|NCT00918671|P1|Participant Flow|Medication-overuse Headache|Chronic daily headache combined with medication overuse
291220|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
291221|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
291222|NCT00918671|E1|Reported Event|Medication-overuse Headache|Chronic daily headache combined with medication overuse
291223|NCT00918580|B1|Baseline|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291224|NCT00918580|P1|Participant Flow|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291225|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291226|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291227|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291228|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291229|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291230|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291231|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291232|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291233|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291356|NCT00918125|B3|Baseline|Total|Total of all reporting groups
291234|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291235|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291236|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
291237|NCT00918580|E4|Reported Event|1-Year Follow-up|Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
291238|NCT00918580|E3|Reported Event|6-Month Follow-up|Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
291239|NCT00918580|E2|Reported Event|13vPnC Dose 2|Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
291240|NCT00918580|E1|Reported Event|13vPnC Dose 1|Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
291241|NCT00918385|B3|Baseline|Total|Total of all reporting groups
291242|NCT00918385|B2|Baseline|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
291243|NCT00918385|B1|Baseline|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
291244|NCT00918385|P2|Participant Flow|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
291245|NCT00918385|P1|Participant Flow|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
291246|NCT00918385|O1|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
291247|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
291248|NCT00918385|O2|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
291249|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
291250|NCT00918385|E3|Reported Event|Combination Nilutamide and Dasatinib|
291251|NCT00918385|E2|Reported Event|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
291252|NCT00918385|E1|Reported Event|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
291253|NCT00918346|B1|Baseline|Entire Study Population|Includes all 43 randomized patients (86 eyes)
291254|NCT00918346|P2|Participant Flow|Unpreserved Formulation First, Then Preserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)
291255|NCT00918346|P1|Participant Flow|Preserved Formulation First, Then Unpreserved Formulation|Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
291256|NCT00918346|O1|Outcome|RM ANCOVA: PP Efficacy Dataset|randomized patients who completed the study per protocol (PP)
291257|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized who received at least one dose of study medication and had at least one IOP measurement
291258|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
291259|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
291260|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
291261|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
291262|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
291263|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
291264|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
291265|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
291266|NCT00918346|E2|Reported Event|Unpreserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks
291267|NCT00918346|E1|Reported Event|Preserved Formulation|Tafluprost 0.0015% preserved formulation once daily for 4 weeks
291268|NCT00918281|B1|Baseline|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
291513|NCT00916721|B3|Baseline|Total|Total of all reporting groups
291269|NCT00918281|P1|Participant Flow|1 Fluciclatide Injection|AH111585 (18F) Injection : AH111585 (18F) Injection
291270|NCT00918281|O1|Outcome|Number of Adverse Events|The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).
291271|NCT00918281|O3|Outcome|Relative Difference|The Relative difference between imaging sessions 1 and 2.
291272|NCT00918281|O2|Outcome|Imaging Session 2|Fluciclatide Injection (AH111585 (18F) Injection)
291273|NCT00918281|O1|Outcome|Imaging Session 1|Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi [370 megabecquerels (MBq)]
291274|NCT00918281|E1|Reported Event|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
291275|NCT00918255|B4|Baseline|Total|Total of all reporting groups
291276|NCT00918255|B3|Baseline|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291277|NCT00918255|B2|Baseline|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291278|NCT00918255|B1|Baseline|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291279|NCT00918255|P3|Participant Flow|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291280|NCT00918255|P2|Participant Flow|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291281|NCT00918255|P1|Participant Flow|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291282|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291283|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291284|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291285|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291286|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291287|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291288|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291289|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291290|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291291|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291292|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291293|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291294|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291295|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291296|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291297|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291298|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291299|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291300|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291301|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291302|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291303|NCT00918255|E3|Reported Event|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
291304|NCT00918255|E2|Reported Event|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
291305|NCT00918255|E1|Reported Event|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
291306|NCT00918203|B3|Baseline|Total|Total of all reporting groups
291307|NCT00918203|B2|Baseline|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291324|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291308|NCT00918203|B1|Baseline|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291309|NCT00918203|P3|Participant Flow|Crossover to Olaratumab Monotherapy|Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.
291310|NCT00918203|P2|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291311|NCT00918203|P1|Participant Flow|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle~Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants who experience progressive disease may cross over to olaratumab monotherapy.~Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours~carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291312|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291313|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291314|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291315|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291316|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291317|NCT00918203|O2|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291318|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291319|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291320|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291321|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291322|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291323|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291354|NCT00918138|E2|Reported Event|Saxagliptin 5 mg + Metformin XR 1500 mg|Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo
291355|NCT00918138|E1|Reported Event|Metformin 2000 mg|Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo
291325|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291326|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291327|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291328|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291329|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291330|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291331|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291332|NCT00918203|O1|Outcome|Olaratumab + Pacilitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291333|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291334|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291335|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291336|NCT00918203|E3|Reported Event|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
291337|NCT00918203|E2|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291338|NCT00918203|E1|Reported Event|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
291339|NCT00918138|B3|Baseline|Total|Total of all reporting groups
291340|NCT00918138|B2|Baseline|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291341|NCT00918138|B1|Baseline|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291342|NCT00918138|P2|Participant Flow|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291343|NCT00918138|P1|Participant Flow|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291344|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291345|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291346|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291347|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291348|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291349|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291350|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291351|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291352|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
291353|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
291357|NCT00918125|B2|Baseline|White Patients|Patients who self-identified as White
291358|NCT00918125|B1|Baseline|Black Patients|Patients who self-identified as African American
291359|NCT00918125|P2|Participant Flow|Video Intervention|Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
291360|NCT00918125|P1|Participant Flow|Standard of Care|Patients in this arm received standard of care (counseling from a physician).
291361|NCT00918125|O2|Outcome|Whites|All Whites in study
291362|NCT00918125|O1|Outcome|African Americans|All African Americans in study
291363|NCT00918125|O2|Outcome|Whites|Whites in study from all study arms
291364|NCT00918125|O1|Outcome|African Americans|African Americans in study from all study arms
291365|NCT00918125|O2|Outcome|Standard of Care|Usual care
291366|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
291367|NCT00918125|O2|Outcome|Standard of Care|Usual care
291368|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
291369|NCT00918125|E1|Reported Event|All Patients|Patients in this arm received standard of care (counseling from a physician).
291370|NCT00917865|B1|Baseline|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
291371|NCT00917865|P1|Participant Flow|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
291372|NCT00917865|O4|Outcome|Mean SUV Maxat 40minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 40 minutes
291373|NCT00917865|O3|Outcome|Mean SUV Max at 28 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 28 minutes
291374|NCT00917865|O2|Outcome|Mean SUV Maxat 16 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 16 minutes
291375|NCT00917865|O1|Outcome|Mean SUV Max at 4 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 4 minutes
291376|NCT00917865|O4|Outcome|Diagnostic Performance Per Sextant 40minutes Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative"
291377|NCT00917865|O3|Outcome|Diagnostic Performance Per Sextant 28mins Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative"
291378|NCT00917865|O2|Outcome|Diagnostic Performance Per sextant16mins Post Injetion|"At this time point, the 120 sextants analysed were categorized as followed:~68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative"
291379|NCT00917865|O1|Outcome|Diagnostic Performance Per Sextant at 4mins Post Injection|Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.
291380|NCT00917865|E1|Reported Event|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
291381|NCT00917852|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|
291382|NCT00917852|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|
291383|NCT00917852|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|
291384|NCT00917852|E1|Reported Event|CTAG Device Trauma Subjects|
291385|NCT00917735|B3|Baseline|Total|Total of all reporting groups
291386|NCT00917735|B2|Baseline|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
291387|NCT00917735|B1|Baseline|Green Tea Extract|Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
291388|NCT00917735|P2|Participant Flow|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
291389|NCT00917735|P1|Participant Flow|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
291390|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
291391|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
291392|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
291393|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
291394|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
291395|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
291396|NCT00917735|E2|Reported Event|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
291397|NCT00917735|E1|Reported Event|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
291398|NCT00917644|B1|Baseline|Total Study Population|New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
291399|NCT00917644|P2|Participant Flow|Reference Drug First|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
291400|NCT00917644|P1|Participant Flow|Test Drug First|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
291401|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291402|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291403|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291404|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291405|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291406|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291407|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291408|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291409|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291410|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291411|NCT00917644|E2|Reported Event|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
291412|NCT00917644|E1|Reported Event|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
291413|NCT00917579|B1|Baseline|Total Number of Participants|All participants received atorvastatin 10 mg tablets (new and marketed).
291414|NCT00917579|P2|Participant Flow|Reference Drug First, Then Test Drug|Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
291415|NCT00917579|P1|Participant Flow|Test Drug First, Then Reference Drug|New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
291416|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
291417|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
291418|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
291419|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
291420|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
291421|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
291422|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
291423|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
291424|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
291425|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
291426|NCT00917579|E2|Reported Event|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
291427|NCT00917579|E1|Reported Event|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose.
291428|NCT00917501|B3|Baseline|Total|Total of all reporting groups
291429|NCT00917501|B2|Baseline|Omega-3|Fish oil - 3 capsules/day
291430|NCT00917501|B1|Baseline|Placebo|Olive oil - 3 capsules/day
291431|NCT00917501|P2|Participant Flow|Omega-3|Fish oil - 3 capsules/day
291432|NCT00917501|P1|Participant Flow|Placebo|Olive oil - 3 capsules/day
291433|NCT00917501|O2|Outcome|Omega-3|Fish oil - 3 capsules/day
291434|NCT00917501|O1|Outcome|Placebo|Olive oil - 3 capsules/day
291435|NCT00917501|E2|Reported Event|Omega-3|Fish oil - 3 capsules/day
291436|NCT00917501|E1|Reported Event|Placebo|Olive oil - 3 capsules/day
291437|NCT00917384|B3|Baseline|Total|Total of all reporting groups
291480|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291481|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291514|NCT00916721|B2|Baseline|Placebo|
291438|NCT00917384|B2|Baseline|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291439|NCT00917384|B1|Baseline|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291440|NCT00917384|P2|Participant Flow|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291441|NCT00917384|P1|Participant Flow|IMC-1121B (Ramucirumab )|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291442|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291443|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291444|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291445|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291446|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291447|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291448|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291449|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291450|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291451|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291452|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291482|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291515|NCT00916721|B1|Baseline|Propranolol|
291453|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291454|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291455|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291456|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291457|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291458|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291459|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291460|NCT00917384|E2|Reported Event|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291461|NCT00917384|E1|Reported Event|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
291462|NCT00917267|B3|Baseline|Total|Total of all reporting groups
291463|NCT00917267|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291464|NCT00917267|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291465|NCT00917267|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291466|NCT00917267|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291467|NCT00917267|O4|Outcome|Exenatide Twice Daily Without SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
291468|NCT00917267|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
291469|NCT00917267|O2|Outcome|Exenatide Twice Daily With SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
291470|NCT00917267|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
291471|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291472|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291473|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291474|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291475|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291476|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291477|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291478|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291479|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291483|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291484|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291485|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291486|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291487|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291488|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291489|NCT00917267|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
291490|NCT00917267|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
291491|NCT00917124|B3|Baseline|Total|Total of all reporting groups
291492|NCT00917124|B2|Baseline|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
291493|NCT00917124|B1|Baseline|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
291494|NCT00917124|P2|Participant Flow|INVOS|INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
291495|NCT00917124|P1|Participant Flow|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
291496|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
291497|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
291498|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
291499|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
291500|NCT00917124|E2|Reported Event|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
291501|NCT00917124|E1|Reported Event|INVOS|INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
291502|NCT00916929|B3|Baseline|Total|Total of all reporting groups
291503|NCT00916929|B2|Baseline|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
291504|NCT00916929|B1|Baseline|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
291505|NCT00916929|P2|Participant Flow|Cardiac Resynchronization Therapy (CRT-D) Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
291506|NCT00916929|P1|Participant Flow|Implantable Cardioverter Defibrillator (ICD) Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
291507|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
291508|NCT00916929|O1|Outcome|Cardiac Resynchronizaiton Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
291509|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
291510|NCT00916929|O1|Outcome|Cardiac Resynchronization Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
291511|NCT00916929|E2|Reported Event|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
291512|NCT00916929|E1|Reported Event|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
291516|NCT00916721|P2|Participant Flow|Placebo|A single oral dose of identical placebo capsule in a double-blind fashion
291517|NCT00916721|P1|Participant Flow|Propranolol|A single oral dose of propranolol or identical placebo capsule in a double-blind fashion. Propranolol dose was 0.67 mg/kg of the short-acting formulation, rounded to the nearest 10 mg, with a minimum dose of 40 mg and a maximum dose of 80 mg
291518|NCT00916721|O2|Outcome|Placebo|
291519|NCT00916721|O1|Outcome|Propranolol|
291520|NCT00916721|O2|Outcome|Placebo|
291521|NCT00916721|O1|Outcome|Propranolol|
291522|NCT00916721|O2|Outcome|Placebo|
291523|NCT00916721|O1|Outcome|Propranolol|
291524|NCT00916721|O2|Outcome|Placebo|
291525|NCT00916721|O1|Outcome|Propranolol|
291526|NCT00916721|E2|Reported Event|Placebo|
291527|NCT00916721|E1|Reported Event|Propranolol|
291528|NCT00916643|B1|Baseline|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291529|NCT00916643|P1|Participant Flow|H.E.L.P. Secura|"All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.~H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.~Flush system with normal saline;~Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;~Mix plasma with equal volume of acetate buffer containing heparin;~Precipitate LDL as a complex with heparin;~Remove LDL-heparin precipitate by continuous circulation through a filter;~Remove heparin with use of a heparin adsorber;~Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;~Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient."
291530|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291531|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291532|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291533|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291579|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291580|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291581|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291582|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291583|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291584|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291585|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291534|NCT00916643|E1|Reported Event|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
291535|NCT00916383|B1|Baseline|All Participants|All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
291536|NCT00916383|P1|Participant Flow|All Participants|"Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.~Upper Back, Upper Arm, Side of Torso~Upper Arm, Side of Torso, Upper Back~Side of Torso, Upper Back, Upper Arm~Upper Back, Side of Torso, Upper Arm~Upper Arm, Upper Back, Side of Torso~Side of Torso, Upper Arm, Upper Back~Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal."
291537|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291538|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291539|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291540|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291541|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291542|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291543|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291544|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291545|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291546|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291547|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291548|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291549|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291550|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291551|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291552|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291553|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291554|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291555|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
291556|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
291557|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
291558|NCT00916383|E3|Reported Event|Placebo Patch|Localized events
291559|NCT00916383|E2|Reported Event|DTP-system|Localized events
291560|NCT00916383|E1|Reported Event|Systemic Events|All enrolled patients
291561|NCT00916370|B3|Baseline|Total|Total of all reporting groups
291562|NCT00916370|B2|Baseline|Long Lesion Registry|Use of long lesion stents.
291563|NCT00916370|B1|Baseline|Core Size Registry|Core size indicates the range of diameters of the stents used.
291564|NCT00916370|P2|Participant Flow|Long Lesion Registry|Use of long lesion stents.
291565|NCT00916370|P1|Participant Flow|Core Size Registry|Core size indicates the range of diameters of the stents used.
291566|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291567|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291568|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291569|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291570|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291571|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291572|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291573|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291574|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291575|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291576|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291577|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291578|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
296258|NCT00903695|B3|Baseline|Total|Total of all reporting groups
291586|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291587|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291588|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291589|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291590|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291591|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291592|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291593|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291594|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291595|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291596|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291597|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291598|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291599|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291600|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291601|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291602|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291603|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291604|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291605|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291606|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291607|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291608|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291609|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291610|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291611|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291612|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291613|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291614|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291615|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291616|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291617|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291618|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291619|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291620|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291621|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291622|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291623|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291624|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291625|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291626|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291627|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291628|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291629|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291630|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291631|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291632|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291633|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291634|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291635|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291636|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291637|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291638|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291639|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291640|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291641|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291642|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291643|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291644|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291645|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291646|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291647|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291648|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291649|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291650|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
296733|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
291651|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291652|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291653|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291654|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291655|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291656|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291657|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291658|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291659|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291660|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291661|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291662|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291663|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291664|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291665|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291666|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291667|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291668|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291669|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291670|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291671|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291672|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291673|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291674|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291675|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291676|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291677|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291678|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291679|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291680|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291681|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291682|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291683|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291684|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291685|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291686|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291687|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291688|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291689|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291690|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291691|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291692|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291693|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291694|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291695|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291696|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291697|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291698|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291699|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291700|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291701|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291702|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291703|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291704|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291705|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291706|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291707|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291708|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291709|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291710|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291711|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291712|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291713|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291714|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291715|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291716|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291717|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291718|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291719|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291720|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
291721|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291722|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291723|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291724|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291725|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291726|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291727|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291728|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291729|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291730|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291731|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291732|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291733|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291734|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
291735|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
291736|NCT00916370|E2|Reported Event|Long Lesion Registry|Use of long lesion stents.
291737|NCT00916370|E1|Reported Event|Core Size Registry|Core size indicates the range of diameters of the stents used.
291738|NCT00916357|B1|Baseline|Overall Study|Participants who received at least 1 dose of Humalog, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during dose-finding (DV) visits or experimental (data gathering) visits.
291739|NCT00916357|P6|Participant Flow|Humulin-R + rHuPH20, Then Humalog + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog alone following a 3- to 14-day washout period.
291740|NCT00916357|P5|Participant Flow|Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3-to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
291741|NCT00916357|P4|Participant Flow|Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog following a 3- to 14-day washout period.
291742|NCT00916357|P3|Participant Flow|Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period
291743|NCT00916357|P2|Participant Flow|Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
291744|NCT00916357|P1|Participant Flow|Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with up to 0.3- to 0.5-U/kg Humalog + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
291745|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291746|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291747|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291748|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291749|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291750|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291751|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291752|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291753|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291754|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291755|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291756|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291757|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291758|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291759|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291760|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291761|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291762|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291763|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291764|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291765|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291766|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291767|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291768|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291769|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291770|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291771|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291772|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291773|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291774|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291775|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291776|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
291777|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
291778|NCT00916357|E3|Reported Event|Humulin-R + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20 during Periods 1, 2, or 3 of the Study
291923|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291924|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291779|NCT00916357|E2|Reported Event|Humalog + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20 during Periods 1, 2, or 3 of the study.
291780|NCT00916357|E1|Reported Event|Humalog Alone|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog during Periods 1, 2, or 3 of the study.
291781|NCT00916344|B1|Baseline|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
291782|NCT00916344|P1|Participant Flow|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
291783|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
291784|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
291785|NCT00916344|E1|Reported Event|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
291786|NCT00916305|B3|Baseline|Total|Total of all reporting groups
291787|NCT00916305|B2|Baseline|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
291788|NCT00916305|B1|Baseline|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
291789|NCT00916305|P2|Participant Flow|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
291790|NCT00916305|P1|Participant Flow|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
291791|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
291792|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
291793|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
291794|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
291795|NCT00916305|E2|Reported Event|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
291796|NCT00916305|E1|Reported Event|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
291797|NCT00916279|B1|Baseline|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291798|NCT00916279|P1|Participant Flow|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291799|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291800|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
291801|NCT00916279|O1|Outcome|Lutonix PTCA Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291802|NCT00916279|O1|Outcome|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291803|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
291804|NCT00916279|E1|Reported Event|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
291805|NCT00916136|B3|Baseline|Total|Total of all reporting groups
291806|NCT00916136|B2|Baseline|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
291807|NCT00916136|B1|Baseline|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
291808|NCT00916136|P2|Participant Flow|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
291809|NCT00916136|P1|Participant Flow|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
291810|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
291811|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
291925|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291926|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291812|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
291813|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
291814|NCT00916136|E2|Reported Event|Skeletal Traction|"A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
291815|NCT00916136|E1|Reported Event|Cutaneous Traction|"Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
291816|NCT00916032|B1|Baseline|All Study Participants|Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.
291817|NCT00916032|P2|Participant Flow|One 3000 IU Vial Then Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291818|NCT00916032|P1|Participant Flow|Two 1500 IU Vials Then One 3000 IU Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
291819|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291820|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291821|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291822|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291823|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291824|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291825|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291826|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291827|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291828|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291829|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291830|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291831|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291832|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291833|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291834|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291835|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291836|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291837|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291838|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291839|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291840|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291841|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291842|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291843|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291844|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291845|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291846|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291847|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291848|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291849|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291850|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291851|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291852|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291853|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
291854|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
291855|NCT00916032|E2|Reported Event|Two 1500 IU Vials|
291856|NCT00916032|E1|Reported Event|One 3000 International Unit (IU) Vial|
291857|NCT00916006|B3|Baseline|Total|Total of all reporting groups
291858|NCT00916006|B2|Baseline|Vehicle|Vehicle gel once daily for 3 consecutive days
291859|NCT00916006|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
291860|NCT00916006|P2|Participant Flow|Vehicle|Vehicle gel once daily for 3 consecutive days
291861|NCT00916006|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
291862|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
291863|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
291864|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
291865|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
291866|NCT00916006|E2|Reported Event|Vehicle|Vehicle gel once daily for 3 consecutive days
291867|NCT00916006|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
291868|NCT00915902|B3|Baseline|Total|Total of all reporting groups
291869|NCT00915902|B2|Baseline|Placebo Followed by Treatment (Lovaza)|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
291870|NCT00915902|B1|Baseline|Treatment (Lovaza) Followed by Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
291871|NCT00915902|P2|Participant Flow|Placebo Then Lovaza|Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
291872|NCT00915902|P1|Participant Flow|Lovaza Then Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
291873|NCT00915902|O2|Outcome|Placebo|Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
291874|NCT00915902|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
291875|NCT00915902|E4|Reported Event|Placebo Followed by Treatment (Lovaza), During Treatment|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
291876|NCT00915902|E3|Reported Event|Placebo Followed by Treatment (Lovaza), During Placebo|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
291927|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291928|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291877|NCT00915902|E2|Reported Event|Treatment (Lovaza) Followed by Placebo, During Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
291878|NCT00915902|E1|Reported Event|Treatment (Lovaza) Followed by Placebo, During Treatment|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
291879|NCT00915876|B3|Baseline|Total|Total of all reporting groups
291880|NCT00915876|B2|Baseline|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
291881|NCT00915876|B1|Baseline|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
291882|NCT00915876|P2|Participant Flow|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
291883|NCT00915876|P1|Participant Flow|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
291884|NCT00915876|O2|Outcome|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
291885|NCT00915876|O1|Outcome|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
291886|NCT00915876|E2|Reported Event|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
291887|NCT00915876|E1|Reported Event|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
291888|NCT00915798|B5|Baseline|Total|Total of all reporting groups
291889|NCT00915798|B4|Baseline|Control Nonsmokers|Control nonsmokers participated in the abstinence condition.
291890|NCT00915798|B3|Baseline|Control Smokers|Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
291891|NCT00915798|B2|Baseline|ADHD Nonsmokers|ADHD nonsmokers participated in the abstinence condition.
291892|NCT00915798|B1|Baseline|ADHD Smokers|ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
291893|NCT00915798|P4|Participant Flow|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
291894|NCT00915798|P3|Participant Flow|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
291895|NCT00915798|P2|Participant Flow|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
291896|NCT00915798|P1|Participant Flow|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
291897|NCT00915798|O4|Outcome|Control Nonsmokers|
291898|NCT00915798|O3|Outcome|Control Smokers|
291899|NCT00915798|O2|Outcome|ADHD Nonsmokers|
291900|NCT00915798|O1|Outcome|ADHD Smokers|
291901|NCT00915798|O4|Outcome|Control Nonsmokers|Control nonsmokers provided a blood sample.
291902|NCT00915798|O3|Outcome|Control Smokers|Control smokers provided a blood sample.
291903|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers with ADHD provided a blood sample.
291904|NCT00915798|O1|Outcome|Smokers With ADHD|Smokers with ADHD provided a blood sample.
291905|NCT00915798|O6|Outcome|Control Smokers After Smoking|Control smokers after smoking the first cigarette of the day
291906|NCT00915798|O5|Outcome|Smokers With ADHD After Smoking|Smokers with ADHD after smoking the first cigarette of the day
291907|NCT00915798|O4|Outcome|Control Nonsmokers|Nonsmokers participate in one condition.
291908|NCT00915798|O3|Outcome|Control Smokers After Abstinence|Control smokers after overnight abstinence (withdrawal).
291909|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers participate in one condition.
291910|NCT00915798|O1|Outcome|Smokers With ADHD After Abstinence|Smokers with ADHD after overnight abstinence (withdrawal).
291911|NCT00915798|E4|Reported Event|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
291912|NCT00915798|E3|Reported Event|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each participant will undergo an fMRI scan during an experimental task consisting of mathematical problems and unpleasant and neutral pictures. Smokers will undergo two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
291913|NCT00915798|E2|Reported Event|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
291914|NCT00915798|E1|Reported Event|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
291915|NCT00915772|B4|Baseline|Total|Total of all reporting groups
291916|NCT00915772|B3|Baseline|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291917|NCT00915772|B2|Baseline|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291918|NCT00915772|B1|Baseline|M1000|Metformin 1000mg monotherapy twice daily
291919|NCT00915772|P3|Participant Flow|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291920|NCT00915772|P2|Participant Flow|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291921|NCT00915772|P1|Participant Flow|M1000|Metformin 1000mg monotherapy twice daily
291922|NCT00915772|O4|Outcome|Post-treat|7 days follow-up period
296734|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
291929|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291930|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291931|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291932|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291933|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291934|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291935|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291936|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291937|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291938|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291939|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291940|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291941|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291942|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291943|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291944|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291945|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291946|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291947|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291948|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291949|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291950|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291951|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291952|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291953|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291954|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291955|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291956|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291957|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291958|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291959|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
291960|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
291961|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
291962|NCT00915772|E3|Reported Event|L2.5+M1000|Linagliptin 2.5 mg + Metformin 1000 mg twice daily
291963|NCT00915772|E2|Reported Event|L2.5+M500|Linagliptin 2.5 mg + Metformin 500 mg twice daily
291964|NCT00915772|E1|Reported Event|M1000|Metformin 1000 mg twice daily
291965|NCT00915759|B1|Baseline|ProKera and Bandage Contact Lens|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
291966|NCT00915759|P1|Participant Flow|ProKera/Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
291967|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 3: bandage contact lens in place until postoperative day 1
291968|NCT00915759|O1|Outcome|ProKera|Group 3: ProKera in place until postoperative day 1
291969|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 2: bandage contact lens in place until postoperative day 3
291970|NCT00915759|O1|Outcome|ProKera|Group 2: ProKera in place until postoperative day 3
291971|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
291972|NCT00915759|O1|Outcome|ProKera|Group 1: ProKera in place until complete corneal re-repithelialization (healing)
291973|NCT00915759|E2|Reported Event|Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
291974|NCT00915759|E1|Reported Event|ProKera|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
291975|NCT00915655|B1|Baseline|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
291976|NCT00915655|P1|Participant Flow|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
291977|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
291978|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
291979|NCT00915655|E1|Reported Event|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
291980|NCT00915603|B3|Baseline|Total|Total of all reporting groups
291981|NCT00915603|B2|Baseline|Paclitaxel/Carboplatin/Everolimus|
291982|NCT00915603|B1|Baseline|Paclitaxel/Carboplatin/Placebo|
291983|NCT00915603|P2|Participant Flow|Paclitaxel/Carboplatin/Everolimus|
291984|NCT00915603|P1|Participant Flow|Paclitaxel/Carboplatin/Placebo|
291985|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
291986|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
291987|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
291988|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
291989|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
291990|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
291991|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
291992|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
291993|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
291994|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
291995|NCT00915603|E2|Reported Event|Paclitaxel/Bevacizumab/Placebo|
291996|NCT00915603|E1|Reported Event|Paclitaxel/Bevacizumab/Everolimus|
291997|NCT00915551|B3|Baseline|Total|Total of all reporting groups
291998|NCT00915551|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
291999|NCT00915551|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
292000|NCT00915551|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
292001|NCT00915551|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
292002|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
292003|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
292004|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
292005|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
292006|NCT00915551|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
292007|NCT00915551|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
292008|NCT00915525|B3|Baseline|Total|Total of all reporting groups
292009|NCT00915525|B2|Baseline|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292010|NCT00915525|B1|Baseline|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292011|NCT00915525|P2|Participant Flow|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292012|NCT00915525|P1|Participant Flow|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292013|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292014|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292015|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292016|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292017|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292018|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292019|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292020|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292021|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292022|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292023|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292024|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292025|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292026|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292027|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292028|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292029|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292030|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292031|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292032|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292033|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292226|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292034|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292035|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292036|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292037|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292038|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292039|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292040|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292041|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292042|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292043|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292044|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292045|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292046|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292047|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292048|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292049|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292050|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292051|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292052|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292053|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292054|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292055|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292056|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292057|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292058|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292059|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292060|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292061|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292062|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292063|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292064|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292065|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292066|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292067|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292752|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
292068|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292069|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292070|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292071|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292072|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292073|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292074|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292075|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292076|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292077|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292078|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292079|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292080|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292081|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292082|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292083|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292084|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292085|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292086|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292087|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292088|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292089|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292090|NCT00915525|E22|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 13|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292091|NCT00915525|E21|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 12|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292092|NCT00915525|E20|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 11|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292093|NCT00915525|E19|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 10|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292094|NCT00915525|E18|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 10|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292095|NCT00915525|E17|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 9|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292096|NCT00915525|E16|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 9|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292097|NCT00915525|E15|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 8|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292098|NCT00915525|E14|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 8|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292099|NCT00915525|E13|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 7|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292100|NCT00915525|E12|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 7|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
296735|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292101|NCT00915525|E11|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 6|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292102|NCT00915525|E10|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 6|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292103|NCT00915525|E9|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 5|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292104|NCT00915525|E8|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 5|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292105|NCT00915525|E7|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 4|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292106|NCT00915525|E6|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 4|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292107|NCT00915525|E5|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 3|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292108|NCT00915525|E4|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 3|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292109|NCT00915525|E3|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 2|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292110|NCT00915525|E2|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 2|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292111|NCT00915525|E1|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 1|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
292112|NCT00915499|B3|Baseline|Total|Total of all reporting groups
292113|NCT00915499|B2|Baseline|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292114|NCT00915499|B1|Baseline|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292115|NCT00915499|P2|Participant Flow|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292116|NCT00915499|P1|Participant Flow|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292117|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
292118|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
292119|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
292120|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
292121|NCT00915499|E2|Reported Event|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292122|NCT00915499|E1|Reported Event|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
292123|NCT00915473|B3|Baseline|Total|Total of all reporting groups
292124|NCT00915473|B2|Baseline|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292125|NCT00915473|B1|Baseline|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292126|NCT00915473|P2|Participant Flow|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292127|NCT00915473|P1|Participant Flow|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292128|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292129|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292130|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292131|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292132|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292133|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292134|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292135|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
292275|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292136|NCT00915473|E2|Reported Event|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
292137|NCT00915473|E1|Reported Event|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
292138|NCT00915356|B6|Baseline|Total|Total of all reporting groups
292139|NCT00915356|B5|Baseline|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292140|NCT00915356|B4|Baseline|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292141|NCT00915356|B3|Baseline|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292142|NCT00915356|B2|Baseline|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292143|NCT00915356|B1|Baseline|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292144|NCT00915356|P5|Participant Flow|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292145|NCT00915356|P4|Participant Flow|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292146|NCT00915356|P3|Participant Flow|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292147|NCT00915356|P2|Participant Flow|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292148|NCT00915356|P1|Participant Flow|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292149|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292150|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292151|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292152|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292153|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292154|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292155|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292156|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292157|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292158|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292159|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292160|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292161|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292162|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292163|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292164|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292165|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
296736|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
292166|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292167|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292168|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292169|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292170|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292171|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292172|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292173|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292174|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292175|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292176|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292177|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292178|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292179|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292180|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292181|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292182|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292183|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292184|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292185|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292186|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292187|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292188|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292189|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292190|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292191|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292192|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292193|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292194|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292276|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292195|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292196|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292197|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292198|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292199|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292200|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292201|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292202|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292203|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292204|NCT00915356|E5|Reported Event|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
292205|NCT00915356|E4|Reported Event|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
292206|NCT00915356|E3|Reported Event|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
292207|NCT00915356|E2|Reported Event|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
292208|NCT00915356|E1|Reported Event|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
292209|NCT00915343|B1|Baseline|Entire Study|Included all participants randomized to receive hydrocortisone MR tablets orally OD first or hydrocortisone tablets orally TID first; in any of the intervention periods during the 12-week cross-over period of Part A or hydrocortisone MR tablets orally OD during the 6-month open-label period of Part B.
292210|NCT00915343|P3|Participant Flow|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD for 6 months.
292211|NCT00915343|P2|Participant Flow|Hydrocortisone TID Then Hydrocortisone MR OD - Part A|Participants received hydrocortisone tablets TID in the first intervention period then novel OD hydrocortisone MR tablets in the second intervention period, at the same total daily dose of 20 to 40 mg for 12 weeks.
292212|NCT00915343|P1|Participant Flow|Hydrocortisone MR OD Then Hydrocortisone TID - Part A|Participants received novel once daily (OD) hydrocortisone modified release (MR) tablets in the first intervention period then hydrocortisone tablets thrice daily (TID) in the second intervention period, at the same total daily dose of 20 to 40 milligram (mg) for 12 weeks.
292213|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292214|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292215|NCT00915343|O1|Outcome|Hydrocortisone OD Versus TID|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study. Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292216|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292217|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292218|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292219|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292220|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|During the 4-week run-in period prior to the first intervention period during Part A, participants on a twice-a-day (BID) regimen were transferred to a thrice-a-day (TID) regimen while maintaining the same total daily hydrocortisone dose. In the first and second intervention periods during Part A, participants were randomised to novel once daily (OD) treatment with hydrocortisone modified release (MR) tablets 20 to 40 milligram (mg) orally and the treatment continued for 12 weeks and returned every 4 weeks for study drug dispensation.
292221|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292222|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292223|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292224|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292225|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292227|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292228|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292229|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292230|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
292231|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292232|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292233|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292234|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292235|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292236|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292237|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292238|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292239|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292240|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292241|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292242|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292243|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292244|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292245|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292246|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292247|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292248|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292249|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292250|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292251|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292252|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292253|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292254|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292255|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292256|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292257|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292258|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292259|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292260|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292261|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292262|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292263|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292264|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292265|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292266|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292267|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292268|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292269|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292270|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292271|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292272|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292273|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292274|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292277|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292278|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292279|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292280|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292281|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292282|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292283|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
292284|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
292285|NCT00915343|E5|Reported Event|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the entire 6-month period of Part B.
292286|NCT00915343|E4|Reported Event|Hydrocortisone MR Tablet OD - Part B (Second 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the second 3 months of Part B (6 months).
292287|NCT00915343|E3|Reported Event|Hydrocortisone MR Tablet OD - Part B (First 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the first 3 months of Part B (6 months).
292288|NCT00915343|E2|Reported Event|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally, thrice daily (TID) during the 12-week period of Part A.
292289|NCT00915343|E1|Reported Event|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone modified release (MR) tablets 20 to 40 mg orally, once daily (OD) during the 12-week period of Part A.
292290|NCT00915278|B7|Baseline|Total|Total of all reporting groups
292291|NCT00915278|B6|Baseline|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292292|NCT00915278|B5|Baseline|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292293|NCT00915278|B4|Baseline|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292294|NCT00915278|B3|Baseline|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292295|NCT00915278|B2|Baseline|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292296|NCT00915278|B1|Baseline|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292297|NCT00915278|P6|Participant Flow|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292298|NCT00915278|P5|Participant Flow|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292299|NCT00915278|P4|Participant Flow|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292300|NCT00915278|P3|Participant Flow|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292301|NCT00915278|P2|Participant Flow|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292302|NCT00915278|P1|Participant Flow|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292303|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292304|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292305|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292306|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296737|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292307|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292308|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292309|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292310|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292311|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292312|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292313|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292314|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292315|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292316|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292317|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292318|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292319|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292320|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292321|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292322|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292323|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292324|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292325|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292326|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292327|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292328|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292329|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296738|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
292330|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292331|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292332|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292333|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292334|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292335|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292336|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292337|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292338|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292339|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292340|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292341|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292342|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292343|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292344|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292345|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292346|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292347|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292348|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292349|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292350|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292351|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292352|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296739|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292353|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292354|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292355|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292356|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292357|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292358|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292359|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292360|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292361|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292362|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292363|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292364|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292365|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292366|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292367|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292368|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292369|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292370|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292371|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292372|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292373|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292374|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292375|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296740|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
292376|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292377|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292378|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292379|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292380|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292381|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292382|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292383|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292384|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292385|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292386|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292387|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292388|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292389|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292390|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292391|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292392|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292393|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292394|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292395|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292396|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292397|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292398|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296741|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292399|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292400|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292401|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292402|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292403|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292404|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292405|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292406|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292407|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292408|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292409|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292410|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292411|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292412|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292413|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292414|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292415|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292416|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292417|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292418|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292419|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292420|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292421|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
296742|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
292422|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292423|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292424|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292425|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292426|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292427|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292428|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292429|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292430|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292431|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292432|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292433|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292434|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292435|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292436|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292437|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292438|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292439|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292440|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292441|NCT00915278|E6|Reported Event|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292442|NCT00915278|E5|Reported Event|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292443|NCT00915278|E4|Reported Event|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292444|NCT00915278|E3|Reported Event|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292445|NCT00915278|E2|Reported Event|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292446|NCT00915278|E1|Reported Event|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
292447|NCT00915148|B1|Baseline|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
292448|NCT00915148|P1|Participant Flow|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
292449|NCT00915148|O1|Outcome|Women Delivered Within 6 Hours|"Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.~Ultrasound examinations: 2D transperineal scan"
292450|NCT00915148|O1|Outcome|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
292451|NCT00915148|E1|Reported Event|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
292452|NCT00914966|B1|Baseline|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
292453|NCT00914966|P1|Participant Flow|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
292454|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292455|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292456|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292457|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292458|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292459|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
292460|NCT00914966|E4|Reported Event|All Subjects|
292461|NCT00914966|E3|Reported Event|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
292462|NCT00914966|E2|Reported Event|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
292463|NCT00914966|E1|Reported Event|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
292464|NCT00914862|B6|Baseline|Total|Total of all reporting groups
292465|NCT00914862|B5|Baseline|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292466|NCT00914862|B4|Baseline|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292467|NCT00914862|B3|Baseline|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292468|NCT00914862|B2|Baseline|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292469|NCT00914862|B1|Baseline|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292470|NCT00914862|P5|Participant Flow|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292471|NCT00914862|P4|Participant Flow|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292472|NCT00914862|P3|Participant Flow|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292473|NCT00914862|P2|Participant Flow|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292474|NCT00914862|P1|Participant Flow|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
292475|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292476|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292477|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292478|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292479|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292480|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292481|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
296743|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292482|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292483|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292484|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292485|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292486|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292487|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292488|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292489|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292490|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292491|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292492|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292493|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292494|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292495|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292496|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292497|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292498|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292499|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292500|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292501|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292502|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292503|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292504|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292505|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292506|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292507|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292508|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292509|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292510|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292511|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292512|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292513|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292514|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292515|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292516|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292517|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292518|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292519|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292520|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292521|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292522|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292523|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292524|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292525|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292526|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292527|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292528|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292529|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292530|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292531|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292532|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292533|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292534|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292535|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292536|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292537|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292538|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292539|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292540|NCT00914862|E5|Reported Event|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
292541|NCT00914862|E4|Reported Event|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
292542|NCT00914862|E3|Reported Event|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
292543|NCT00914862|E2|Reported Event|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
292544|NCT00914862|E1|Reported Event|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
292545|NCT00914849|B3|Baseline|Total|Total of all reporting groups
292546|NCT00914849|B2|Baseline|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292547|NCT00914849|B1|Baseline|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292548|NCT00914849|P2|Participant Flow|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292549|NCT00914849|P1|Participant Flow|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg intravenous (IV)~Leukopheresis~Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292550|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292551|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292552|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292553|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292554|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292555|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292556|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292557|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292588|NCT00914810|E1|Reported Event|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
292589|NCT00914589|B4|Baseline|Total|Total of all reporting groups
292558|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292559|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292560|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292561|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292562|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292563|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292564|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292565|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292566|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292567|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292568|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292569|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292570|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292571|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292572|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292573|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292574|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292575|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292576|NCT00914849|E2|Reported Event|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
292577|NCT00914849|E1|Reported Event|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
292578|NCT00914810|B3|Baseline|Total|Total of all reporting groups
292579|NCT00914810|B2|Baseline|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
292580|NCT00914810|B1|Baseline|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
292581|NCT00914810|P2|Participant Flow|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
292582|NCT00914810|P1|Participant Flow|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
292583|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
292584|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
292585|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
292586|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
292587|NCT00914810|E2|Reported Event|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
292590|NCT00914589|B3|Baseline|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292591|NCT00914589|B2|Baseline|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292592|NCT00914589|B1|Baseline|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292593|NCT00914589|P3|Participant Flow|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292594|NCT00914589|P2|Participant Flow|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292595|NCT00914589|P1|Participant Flow|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292596|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292597|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292598|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292599|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292600|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292601|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292602|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292603|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292604|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292605|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292606|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292607|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292608|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292609|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292610|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292611|NCT00914589|E3|Reported Event|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292612|NCT00914589|E2|Reported Event|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
292613|NCT00914589|E1|Reported Event|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
292614|NCT00914485|B1|Baseline|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
292615|NCT00914485|P1|Participant Flow|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
292616|NCT00914485|O1|Outcome|Arm 1|"Provider clinical communication training intervention~Provider Communication Skills Training: Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
292617|NCT00914485|E1|Reported Event|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
292618|NCT00914459|B3|Baseline|Total|Total of all reporting groups
292619|NCT00914459|B2|Baseline|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292620|NCT00914459|B1|Baseline|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292621|NCT00914459|P2|Participant Flow|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292622|NCT00914459|P1|Participant Flow|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 international units per kilogram [IU/kg] up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the Summary of Product Characteristics (SmPC).
292623|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292624|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292625|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292626|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292627|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292628|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292629|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292630|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292631|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292632|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292633|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292634|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292635|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292636|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292637|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292638|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292639|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged less than or equal to [<=] 12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292640|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292641|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292642|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292643|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292644|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292645|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292646|NCT00914459|E1|Reported Event|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
292647|NCT00914186|B5|Baseline|Total|Total of all reporting groups
292648|NCT00914186|B4|Baseline|TS-022 0.020%|lotion/once daily
292649|NCT00914186|B3|Baseline|TS-022 0.010%|lotion/once daily
292650|NCT00914186|B2|Baseline|TS-022 0.005%|lotion/once daily
292651|NCT00914186|B1|Baseline|Vehicle|once daily
292652|NCT00914186|P4|Participant Flow|TS-022 0.020%|lotion/once daily
292653|NCT00914186|P3|Participant Flow|TS-022 0.010%|lotion/once daily
292654|NCT00914186|P2|Participant Flow|TS-022 0.005%|lotion/once daily
292655|NCT00914186|P1|Participant Flow|Vehicle|once daily
292656|NCT00914186|O2|Outcome|TS-022|lotion/once daily
292657|NCT00914186|O1|Outcome|Vehicle|once daily
292658|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292659|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292660|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292661|NCT00914186|O1|Outcome|Vehicle|once daily
292662|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292663|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292664|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292665|NCT00914186|O1|Outcome|Vehicle|once daily
292666|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292667|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292668|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292669|NCT00914186|O1|Outcome|Vehicle|once daily
292670|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292671|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292672|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292673|NCT00914186|O1|Outcome|Vehicle|once daily
292674|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292675|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292676|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292677|NCT00914186|O1|Outcome|Vehicle|once daily
292678|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
292679|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
292680|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
292681|NCT00914186|O1|Outcome|Vehicle|once daily
292682|NCT00914186|E4|Reported Event|TS-022 0.020%|lotion/once daily
292683|NCT00914186|E3|Reported Event|TS-022 0.010%|lotion/once daily
292684|NCT00914186|E2|Reported Event|TS-022 0.005%|lotion/once daily
292685|NCT00914186|E1|Reported Event|Vehicle|once daily
292686|NCT00913913|B1|Baseline|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292687|NCT00913913|P1|Participant Flow|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292688|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292689|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292690|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292691|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292744|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292745|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292746|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
296744|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
292692|NCT00913913|E1|Reported Event|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
292693|NCT00913770|B4|Baseline|Total|Total of all reporting groups
292694|NCT00913770|B3|Baseline|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
292695|NCT00913770|B2|Baseline|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
292696|NCT00913770|B1|Baseline|Standard Care|Standard Care including receiving a referral.
292697|NCT00913770|P3|Participant Flow|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
292698|NCT00913770|P2|Participant Flow|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
292699|NCT00913770|P1|Participant Flow|Standard Care|Standard Care including receiving a referral.
292700|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
292701|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
292702|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
292703|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
292704|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
292705|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
292747|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292748|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292749|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
292750|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292751|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292706|NCT00913770|E3|Reported Event|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
292707|NCT00913770|E2|Reported Event|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
292708|NCT00913770|E1|Reported Event|Standard Care|Standard Care including receiving a referral.
292709|NCT00913744|B3|Baseline|Total|Total of all reporting groups
292710|NCT00913744|B2|Baseline|Sham|Sham injection
292711|NCT00913744|B1|Baseline|Ocriplasmin|Intravitreal injection (125 µg)
292712|NCT00913744|P2|Participant Flow|Sham|Sham injection
292713|NCT00913744|P1|Participant Flow|Ocriplasmin|Intravitreal injection (125 µg)
292714|NCT00913744|O2|Outcome|Sham|Sham injection
292715|NCT00913744|O1|Outcome|Ocriplasmin|Intravitreal injection (125 µg)
292716|NCT00913744|E2|Reported Event|Sham|Sham injection
292717|NCT00913744|E1|Reported Event|Ocriplasmin|Intravitreal injection (125 µg)
292718|NCT00913692|B1|Baseline|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
292719|NCT00913692|P1|Participant Flow|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
292720|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
292721|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
292722|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
292723|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
292724|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
292725|NCT00913692|E3|Reported Event|Treatment Phase 2|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
292726|NCT00913692|E2|Reported Event|Washout|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
292727|NCT00913692|E1|Reported Event|Treatment Phase 1|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
292728|NCT00913523|B4|Baseline|Total|Total of all reporting groups
292729|NCT00913523|B3|Baseline|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292730|NCT00913523|B2|Baseline|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292731|NCT00913523|B1|Baseline|Tampon With GML|Regular and Super Tampon with GML added to the cover
292732|NCT00913523|P3|Participant Flow|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292733|NCT00913523|P2|Participant Flow|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292734|NCT00913523|P1|Participant Flow|Tampon With GML|Regular and Super Tampon with GML added to the cover
292735|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292736|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292737|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
292738|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292739|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292740|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
292741|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292742|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292743|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
292753|NCT00913523|E3|Reported Event|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
292754|NCT00913523|E2|Reported Event|Tampon Without GML|Regular and Super Tampon without GML added to the cover
292755|NCT00913523|E1|Reported Event|Tampon With GML|Regular and Super Tampon with GML added to the cover
292756|NCT00913510|B3|Baseline|Total|Total of all reporting groups
292757|NCT00913510|B2|Baseline|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
292758|NCT00913510|B1|Baseline|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
292759|NCT00913510|P2|Participant Flow|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
292760|NCT00913510|P1|Participant Flow|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.
292761|NCT00913510|O2|Outcome|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
292762|NCT00913510|O1|Outcome|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
292763|NCT00913510|E2|Reported Event|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
292764|NCT00913510|E1|Reported Event|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
292765|NCT00913458|B1|Baseline|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292766|NCT00913458|P7|Participant Flow|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292767|NCT00913458|P6|Participant Flow|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292768|NCT00913458|P5|Participant Flow|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292769|NCT00913458|P4|Participant Flow|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292770|NCT00913458|P3|Participant Flow|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292771|NCT00913458|P2|Participant Flow|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292772|NCT00913458|P1|Participant Flow|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292838|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
296745|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
292773|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292774|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292775|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292776|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292777|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292778|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292779|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292780|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292894|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
292895|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
292896|NCT00913263|O1|Outcome|Part I|Patients (24 patients) in Part I have been injected with Liproca Depot once.
292781|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292782|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292783|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292784|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292785|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292786|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292787|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292788|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292839|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
296746|NCT00902174|E2|Reported Event|Placebo|Placebo to imatinib
292789|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292790|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292791|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292792|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292793|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292794|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292795|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292796|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292897|NCT00913263|O1|Outcome|Group 1|24 patients (Part I of the study) have been injected with Liproca Depot once.
292898|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
292902|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
292797|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292798|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292799|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292800|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292801|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292802|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292803|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292804|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292899|NCT00913263|E1|Reported Event|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
292900|NCT00913133|B1|Baseline|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
292805|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292806|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292807|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292808|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292809|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292810|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292811|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292812|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292840|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
296747|NCT00902174|E1|Reported Event|Imatinib|imatinib mesylate
292813|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292814|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292815|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292816|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292817|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292818|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292819|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292820|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292841|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292821|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292822|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292823|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292824|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292825|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292826|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292827|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292828|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292887|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292888|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292889|NCT00913380|E2|Reported Event|Standard-dose CT|Aimed to 8 mSv in an average patient
296748|NCT00902161|B3|Baseline|Total|Total of all reporting groups
292829|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292830|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292831|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292832|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292833|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292834|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
292835|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292836|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292837|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292890|NCT00913380|E1|Reported Event|Low-dose CT|Aimed to 2 mSv in an average patient
292891|NCT00913263|B1|Baseline|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
292901|NCT00913133|P1|Participant Flow|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
292842|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292843|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292844|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292845|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292846|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292847|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292848|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292849|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292850|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292851|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292852|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292853|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292892|NCT00913263|P1|Participant Flow|Hydroxyflutamide (2-HOF)|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
292893|NCT00913263|O1|Outcome|Part 1|Patients (24 patients) have been injected with Liproca depot once
292854|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
292855|NCT00913458|E7|Reported Event|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292856|NCT00913458|E6|Reported Event|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292857|NCT00913458|E5|Reported Event|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
292858|NCT00913458|E4|Reported Event|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292859|NCT00913458|E3|Reported Event|MTX + PBO (Phase 2)|"In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.~Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
292860|NCT00913458|E2|Reported Event|E25 + MTX (Phase 2)|"In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
292861|NCT00913458|E1|Reported Event|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
292862|NCT00913380|B3|Baseline|Total|Total of all reporting groups
292863|NCT00913380|B2|Baseline|Standard-dose CT|Aimed to 8 mSv in an average patient
292864|NCT00913380|B1|Baseline|Low-dose CT|Aimed to 2 mSv in an average patient
292865|NCT00913380|P2|Participant Flow|Standard-dose CT|Aimed to 8 mSv in an average patient
292866|NCT00913380|P1|Participant Flow|Low-dose CT|Aimed to 2 mSv in an average patient
292867|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292868|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292869|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292870|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292871|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292872|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292873|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292874|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292875|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292876|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292877|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292878|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292879|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292880|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292881|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292882|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292883|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292884|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292885|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
292886|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
292903|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
292904|NCT00913133|E1|Reported Event|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
292905|NCT00913081|B1|Baseline|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
292906|NCT00913081|P1|Participant Flow|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
292907|NCT00913081|O4|Outcome|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292908|NCT00913081|O3|Outcome|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292909|NCT00913081|O2|Outcome|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292910|NCT00913081|O1|Outcome|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292911|NCT00913081|E4|Reported Event|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292912|NCT00913081|E3|Reported Event|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292913|NCT00913081|E2|Reported Event|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292914|NCT00913081|E1|Reported Event|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
292915|NCT00913003|B3|Baseline|Total|Total of all reporting groups
292916|NCT00913003|B2|Baseline|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
292917|NCT00913003|B1|Baseline|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292918|NCT00913003|P2|Participant Flow|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
292919|NCT00913003|P1|Participant Flow|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292920|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
292921|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292922|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
292923|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292924|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
292925|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292926|NCT00913003|E2|Reported Event|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
293801|NCT00910715|O1|Outcome|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
292927|NCT00913003|E1|Reported Event|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
292928|NCT00912964|B4|Baseline|Total|Total of all reporting groups
292929|NCT00912964|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292930|NCT00912964|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292931|NCT00912964|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292932|NCT00912964|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292933|NCT00912964|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292934|NCT00912964|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292935|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292936|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292937|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292938|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292939|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292940|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292941|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292942|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292943|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292944|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292945|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292946|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292947|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292948|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292949|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292950|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292951|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292952|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292953|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292954|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292955|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292956|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292957|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292958|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292959|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292960|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292961|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292962|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292963|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292964|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292965|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292966|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292967|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292968|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292969|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292970|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292971|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292972|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292973|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292974|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292975|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292976|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292977|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292978|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292979|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292980|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292981|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292982|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292983|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292984|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292985|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292986|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292987|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292988|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292989|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292990|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292991|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292992|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292993|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292994|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292995|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292996|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
292997|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
292998|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
292999|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293000|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293001|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293002|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293003|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293004|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293005|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293006|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293007|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293008|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293009|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293010|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293011|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293012|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293013|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293014|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293015|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293016|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293017|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293018|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293019|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293020|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293021|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293022|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293023|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293024|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293025|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293026|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293027|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293028|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293029|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293030|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293031|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293032|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293033|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293034|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293035|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293036|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293037|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293038|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293039|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293040|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293041|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293042|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293043|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293044|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293045|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293046|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293047|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293048|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293049|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293050|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293051|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293052|NCT00912964|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
293053|NCT00912964|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
293054|NCT00912964|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
293055|NCT00912925|B3|Baseline|Total|Total of all reporting groups
293056|NCT00912925|B2|Baseline|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293057|NCT00912925|B1|Baseline|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293058|NCT00912925|P2|Participant Flow|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293059|NCT00912925|P1|Participant Flow|Placebo|Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293060|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293061|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293062|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293063|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293064|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293065|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293066|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293067|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293068|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293206|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293069|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293070|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293071|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293072|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
293073|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
293074|NCT00912925|E2|Reported Event|Aldurazyme***Check Title***|Aldurazyme***Check Description***
293075|NCT00912925|E1|Reported Event|Placebo***Check Title***|Placebo***Check Description***
293076|NCT00912912|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
293077|NCT00912912|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
293078|NCT00912912|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
293079|NCT00912912|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
293080|NCT00912808|B3|Baseline|Total|Total of all reporting groups
293081|NCT00912808|B2|Baseline|Sugar Pill|
293082|NCT00912808|B1|Baseline|Donepezil|
293083|NCT00912808|P2|Participant Flow|Sugar Pill|
293084|NCT00912808|P1|Participant Flow|Donepezil|
293085|NCT00912808|O2|Outcome|Sugar Pill|
293086|NCT00912808|O1|Outcome|Donepezil|
293087|NCT00912808|O2|Outcome|Sugar Pill|
293088|NCT00912808|O1|Outcome|Donepezil|
293089|NCT00912808|E2|Reported Event|Sugar Pill|
293090|NCT00912808|E1|Reported Event|Donepezil|
293091|NCT00912795|B3|Baseline|Total|Total of all reporting groups
293092|NCT00912795|B2|Baseline|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293093|NCT00912795|B1|Baseline|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293094|NCT00912795|P2|Participant Flow|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293095|NCT00912795|P1|Participant Flow|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293096|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293097|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293098|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293207|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293099|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293100|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293101|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293102|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293103|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293104|NCT00912795|E2|Reported Event|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
293105|NCT00912795|E1|Reported Event|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
293106|NCT00912782|B3|Baseline|Total|Total of all reporting groups
293107|NCT00912782|B2|Baseline|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
293108|NCT00912782|B1|Baseline|Placebo|Placebo one time per week for 3 weeks
293109|NCT00912782|P2|Participant Flow|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
293110|NCT00912782|P1|Participant Flow|Placebo|Placebo one time per week for 3 weeks
293111|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
293112|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
293113|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
293114|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
293115|NCT00912782|E2|Reported Event|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
293116|NCT00912782|E1|Reported Event|Placebo|Placebo one time per week for 3 weeks
293117|NCT00912743|B3|Baseline|Total|Total of all reporting groups
293118|NCT00912743|B2|Baseline|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293119|NCT00912743|B1|Baseline|MSI-H|MSI-H group receiving olaparib 400mg BID
293120|NCT00912743|P2|Participant Flow|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293121|NCT00912743|P1|Participant Flow|MSI-H|MSI-H group receiving olaparib 400mg BID
293122|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293123|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
293124|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293125|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
293126|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293127|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
293128|NCT00912743|E2|Reported Event|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
293129|NCT00912743|E1|Reported Event|MSI-H|MSI-H group receiving olaparib 400mg BID
293130|NCT00912509|B3|Baseline|Total|Total of all reporting groups
293131|NCT00912509|B2|Baseline|45 Minute Light Duration|"45 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293208|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293132|NCT00912509|B1|Baseline|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293133|NCT00912509|P2|Participant Flow|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293134|NCT00912509|P1|Participant Flow|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293135|NCT00912509|O2|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293136|NCT00912509|O1|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293137|NCT00912509|E2|Reported Event|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293138|NCT00912509|E1|Reported Event|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
293139|NCT00912405|B1|Baseline|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293140|NCT00912405|P1|Participant Flow|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293141|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293142|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293143|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293144|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293145|NCT00912405|E1|Reported Event|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
293146|NCT00912301|B4|Baseline|Total|Total of all reporting groups
293147|NCT00912301|B3|Baseline|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293148|NCT00912301|B2|Baseline|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293149|NCT00912301|B1|Baseline|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293150|NCT00912301|P3|Participant Flow|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293151|NCT00912301|P2|Participant Flow|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293152|NCT00912301|P1|Participant Flow|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293153|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293154|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293155|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293156|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293157|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293158|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293159|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293160|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293161|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293162|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293163|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293164|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293165|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293166|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293167|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293168|NCT00912301|E3|Reported Event|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
293169|NCT00912301|E2|Reported Event|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
293170|NCT00912301|E1|Reported Event|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
293171|NCT00912288|B3|Baseline|Total|Total of all reporting groups
293172|NCT00912288|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293173|NCT00912288|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293803|NCT00910715|E2|Reported Event|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
293174|NCT00912288|P2|Participant Flow|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293175|NCT00912288|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293176|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293177|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293178|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293179|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293180|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293181|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293182|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293183|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293184|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293185|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293186|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293187|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293188|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293189|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293190|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293191|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293192|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293193|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293194|NCT00912288|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
293195|NCT00912288|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
293196|NCT00912223|B1|Baseline|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293197|NCT00912223|P1|Participant Flow|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293198|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293199|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293200|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293201|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293202|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293203|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293204|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293205|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293209|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293210|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293211|NCT00912223|E1|Reported Event|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
293212|NCT00912158|B4|Baseline|Total|Total of all reporting groups
293213|NCT00912158|B3|Baseline|Standard Treatment|Standard medical therapy alone
293214|NCT00912158|B2|Baseline|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
293215|NCT00912158|B1|Baseline|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
293216|NCT00912158|P3|Participant Flow|Standard Treatment|Standard medical therapy alone
293217|NCT00912158|P2|Participant Flow|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
293218|NCT00912158|P1|Participant Flow|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
293219|NCT00912158|O3|Outcome|Standard Treatment|Standard medical therapy alone
293220|NCT00912158|O2|Outcome|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
293221|NCT00912158|O1|Outcome|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
293222|NCT00912093|B6|Baseline|Total|Total of all reporting groups
293223|NCT00912093|B5|Baseline|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
293224|NCT00912093|B4|Baseline|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293225|NCT00912093|B3|Baseline|Randomized-Icatibant (Blinded Treatment)--Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293226|NCT00912093|B2|Baseline|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293227|NCT00912093|B1|Baseline|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293228|NCT00912093|P5|Participant Flow|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
293229|NCT00912093|P4|Participant Flow|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293230|NCT00912093|P3|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
293231|NCT00912093|P2|Participant Flow|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293232|NCT00912093|P1|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
293233|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293234|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293235|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293236|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293237|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293238|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293239|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293240|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293241|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
293242|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
293243|NCT00912093|E4|Reported Event|Open Label Extension – Icatibant (Open Label)|Subjects who treated with icatibant 30 mg in the open label extension phase
293244|NCT00912093|E3|Reported Event|Controlled Phase - Icatibant (Open Label)|Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
293301|NCT00912002|E1|Reported Event|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
293245|NCT00912093|E2|Reported Event|Controlled Phase -Placebo (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase
293246|NCT00912093|E1|Reported Event|Controlled Phase - Icatibant (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
293247|NCT00912028|B4|Baseline|Total|Total of all reporting groups
293248|NCT00912028|B3|Baseline|Methafilcon A|"contact lens~methafilcon A: contact lens"
293249|NCT00912028|B2|Baseline|Balafilcon A|"contact lens~balafilcon A: contact lens"
293250|NCT00912028|B1|Baseline|Senofilcon A|"contact lens~senofilcon A: contact lens"
293251|NCT00912028|P5|Participant Flow|Vifilcon A|"contact lens~vifilcon A: contact lens"
293252|NCT00912028|P4|Participant Flow|Methafilcon A|"contact lens~methafilcon A: contact lens"
293253|NCT00912028|P3|Participant Flow|Balafilcon A|"contact lens~balafilcon A: contact lens"
293254|NCT00912028|P2|Participant Flow|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
293255|NCT00912028|P1|Participant Flow|Senofilcon A|"contact lens~senofilcon A: contact lens"
293256|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293257|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293258|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293259|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293260|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293261|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293262|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293263|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293264|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293265|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293266|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293267|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293268|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293269|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293270|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293271|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
293272|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
293273|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
293274|NCT00912028|E5|Reported Event|Vifilcon A|"contact lens~vifilcon A: contact lens"
293275|NCT00912028|E4|Reported Event|Methafilcon A|"contact lens~methafilcon A: contact lens"
293276|NCT00912028|E3|Reported Event|Balafilcon A|"contact lens~balafilcon A: contact lens"
293277|NCT00912028|E2|Reported Event|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
293278|NCT00912028|E1|Reported Event|Senofilcon A|"contact lens~senofilcon A: contact lens"
293279|NCT00912015|B5|Baseline|Total|Total of all reporting groups
293280|NCT00912015|B4|Baseline|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293281|NCT00912015|B3|Baseline|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293282|NCT00912015|B2|Baseline|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293283|NCT00912015|B1|Baseline|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293284|NCT00912015|P4|Participant Flow|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293285|NCT00912015|P3|Participant Flow|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293286|NCT00912015|P2|Participant Flow|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293287|NCT00912015|P1|Participant Flow|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293288|NCT00912015|O4|Outcome|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293289|NCT00912015|O3|Outcome|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293290|NCT00912015|O2|Outcome|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293291|NCT00912015|O1|Outcome|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293292|NCT00912015|E4|Reported Event|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293293|NCT00912015|E3|Reported Event|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293294|NCT00912015|E2|Reported Event|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293295|NCT00912015|E1|Reported Event|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
293296|NCT00912002|B1|Baseline|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
293297|NCT00912002|P1|Participant Flow|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
293298|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
293299|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
293300|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
293302|NCT00911989|B1|Baseline|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
293303|NCT00911989|P1|Participant Flow|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
293304|NCT00911989|O1|Outcome|Transvaginal Sleeve Gastrectomy|All subjects on whom the surgery was attempted.
293305|NCT00911989|E1|Reported Event|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
293306|NCT00911937|B3|Baseline|Total|Total of all reporting groups
293307|NCT00911937|B2|Baseline|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293308|NCT00911937|B1|Baseline|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293309|NCT00911937|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293310|NCT00911937|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293311|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293312|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293313|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293314|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293315|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293316|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293317|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293318|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293319|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293320|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293321|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293322|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293323|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293324|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293325|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293326|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293327|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293328|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293329|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293330|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293331|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293332|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293333|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293334|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293335|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293336|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293337|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293338|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293339|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293340|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293341|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293342|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293343|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293344|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293345|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293346|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293347|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293348|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293349|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293350|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293351|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293352|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293353|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293354|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293355|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293356|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293357|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293358|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293359|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293360|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293361|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293362|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293363|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
299108|NCT00891735|B5|Baseline|Total|Total of all reporting groups
293364|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293365|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293366|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293367|NCT00911937|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
293368|NCT00911937|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
293369|NCT00911898|B1|Baseline|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
293370|NCT00911898|P1|Participant Flow|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
293371|NCT00911898|O1|Outcome|MM-111|All participants
293372|NCT00911898|E1|Reported Event|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
293373|NCT00911859|B4|Baseline|Total|Total of all reporting groups
293374|NCT00911859|B3|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293375|NCT00911859|B2|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293376|NCT00911859|B1|Baseline|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293377|NCT00911859|P3|Participant Flow|Part 2: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293378|NCT00911859|P2|Participant Flow|Part 2: VMP|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293379|NCT00911859|P1|Participant Flow|Part 1: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293380|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293381|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293382|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293383|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293384|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293385|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293386|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293387|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293388|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293389|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293390|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293391|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293392|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293393|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293394|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293395|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293396|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293397|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293398|NCT00911859|E4|Reported Event|Part 2, Maintenance Period: Siltuximab|Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
293399|NCT00911859|E3|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293400|NCT00911859|E2|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293401|NCT00911859|E1|Reported Event|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
293402|NCT00911807|B4|Baseline|Total|Total of all reporting groups
293403|NCT00911807|B3|Baseline|Donepezil|
293404|NCT00911807|B2|Baseline|Cerebrolysin|
293405|NCT00911807|B1|Baseline|Cerebrolysin + Donepezil|
293406|NCT00911807|P3|Participant Flow|Donepezil|
293407|NCT00911807|P2|Participant Flow|Cerebrolysin|
293408|NCT00911807|P1|Participant Flow|Cerebrolysin + Donepezil|
293409|NCT00911807|O3|Outcome|Donepezil|
293410|NCT00911807|O2|Outcome|Cerebrolysin|
293411|NCT00911807|O1|Outcome|Cerebrolysin + Donepezil|
293412|NCT00911807|E3|Reported Event|Donepezil|
293413|NCT00911807|E2|Reported Event|Cerebrolysin|
293414|NCT00911807|E1|Reported Event|Cerebrolysin + Donepezil|
293415|NCT00911768|B3|Baseline|Total|Total of all reporting groups
293416|NCT00911768|B2|Baseline|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293417|NCT00911768|B1|Baseline|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293418|NCT00911768|P2|Participant Flow|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293419|NCT00911768|P1|Participant Flow|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293420|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293421|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293422|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293423|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293424|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293425|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293426|NCT00911768|E2|Reported Event|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
293427|NCT00911768|E1|Reported Event|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
293428|NCT00911742|B3|Baseline|Total|Total of all reporting groups
293429|NCT00911742|B2|Baseline|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293430|NCT00911742|B1|Baseline|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293431|NCT00911742|P2|Participant Flow|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293432|NCT00911742|P1|Participant Flow|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293433|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293584|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
293434|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293435|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293436|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293437|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293438|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293439|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293440|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293441|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293442|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293443|NCT00911742|E2|Reported Event|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293444|NCT00911742|E1|Reported Event|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
293445|NCT00911612|B3|Baseline|Total|Total of all reporting groups
293446|NCT00911612|B2|Baseline|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293447|NCT00911612|B1|Baseline|Colesevelam|Participants received colesevelam 1.875 g twice daily
293448|NCT00911612|P2|Participant Flow|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293449|NCT00911612|P1|Participant Flow|Colesevelam|Participants received colesevelam 1.875 g twice daily
293450|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293451|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
293452|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293453|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
293454|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293455|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
293456|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293457|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
293458|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293459|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
293460|NCT00911612|E2|Reported Event|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
293461|NCT00911612|E1|Reported Event|Colesevelam|Participants received colesevelam 1.875 g twice daily
293462|NCT00911547|B5|Baseline|Total|Total of all reporting groups
293463|NCT00911547|B4|Baseline|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293464|NCT00911547|B3|Baseline|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293465|NCT00911547|B2|Baseline|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293466|NCT00911547|B1|Baseline|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293467|NCT00911547|P4|Participant Flow|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293468|NCT00911547|P3|Participant Flow|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293585|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293804|NCT00910715|E1|Reported Event|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
293469|NCT00911547|P2|Participant Flow|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293470|NCT00911547|P1|Participant Flow|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293471|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293472|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293473|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293474|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293475|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293476|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293477|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293478|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293479|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293480|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293481|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293482|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293483|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293484|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293485|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293486|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293487|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293488|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293489|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293586|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
293490|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293491|NCT00911547|E4|Reported Event|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293492|NCT00911547|E3|Reported Event|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
293493|NCT00911547|E2|Reported Event|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293494|NCT00911547|E1|Reported Event|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
293495|NCT00911534|B3|Baseline|Total|Total of all reporting groups
293496|NCT00911534|B2|Baseline|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293497|NCT00911534|B1|Baseline|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293498|NCT00911534|P2|Participant Flow|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293499|NCT00911534|P1|Participant Flow|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293500|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293501|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293502|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293503|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293504|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293505|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293506|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293507|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293508|NCT00911534|E2|Reported Event|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
293509|NCT00911534|E1|Reported Event|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
293510|NCT00911495|B1|Baseline|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293511|NCT00911495|P1|Participant Flow|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293512|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293513|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293514|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293515|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293516|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293517|NCT00911495|E1|Reported Event|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
293518|NCT00911443|B6|Baseline|Total|Total of all reporting groups
293519|NCT00911443|B5|Baseline|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293520|NCT00911443|B4|Baseline|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293521|NCT00911443|B3|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293522|NCT00911443|B2|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293523|NCT00911443|B1|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293524|NCT00911443|P5|Participant Flow|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293525|NCT00911443|P4|Participant Flow|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293526|NCT00911443|P3|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293527|NCT00911443|P2|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293528|NCT00911443|P1|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293529|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293530|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293531|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293532|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293533|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293534|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293535|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293536|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293537|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293538|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293539|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293540|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293541|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293542|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293543|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
293544|NCT00911326|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
293545|NCT00911326|P1|Participant Flow|Lymphoseek|Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
293546|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
293547|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
293548|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
293549|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
293550|NCT00911326|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
293551|NCT00911300|B3|Baseline|Total|Total of all reporting groups
293587|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293805|NCT00910689|B5|Baseline|Total|Total of all reporting groups
293552|NCT00911300|B2|Baseline|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293553|NCT00911300|B1|Baseline|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293554|NCT00911300|P2|Participant Flow|Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)|Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293555|NCT00911300|P1|Participant Flow|Fondaparinux|For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293556|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293557|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293558|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293559|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293560|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293561|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293562|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293563|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293564|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293565|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293566|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293567|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293568|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293569|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293588|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
293589|NCT00911170|B3|Baseline|Total|Total of all reporting groups
293570|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293571|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293572|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293573|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293574|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293575|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293576|NCT00911300|E2|Reported Event|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
293577|NCT00911300|E1|Reported Event|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
293578|NCT00911274|B3|Baseline|Total|Total of all reporting groups
293579|NCT00911274|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
293580|NCT00911274|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
293581|NCT00911274|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
293582|NCT00911274|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
293583|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293590|NCT00911170|B2|Baseline|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293591|NCT00911170|B1|Baseline|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293592|NCT00911170|P2|Participant Flow|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
293593|NCT00911170|P1|Participant Flow|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
293594|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293595|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293596|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293597|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293598|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293599|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293600|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293601|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293602|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293603|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293604|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293605|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293606|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293607|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293608|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293609|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293610|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293611|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293612|NCT00911170|E2|Reported Event|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293613|NCT00911170|E1|Reported Event|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
293614|NCT00911157|B3|Baseline|Total|Total of all reporting groups
293615|NCT00911157|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293616|NCT00911157|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293617|NCT00911157|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293618|NCT00911157|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293619|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293620|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293621|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293622|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293623|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293624|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293625|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293626|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293627|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
299738|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
293628|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293629|NCT00911157|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
293630|NCT00911157|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
293631|NCT00911144|B3|Baseline|Total|Total of all reporting groups
293632|NCT00911144|B2|Baseline|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293633|NCT00911144|B1|Baseline|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293634|NCT00911144|P2|Participant Flow|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293635|NCT00911144|P1|Participant Flow|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293636|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293637|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293638|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293639|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293640|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293641|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293642|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293643|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293644|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293645|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293646|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293647|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293648|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293649|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293682|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
293650|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293651|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293652|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293653|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293654|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293655|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293656|NCT00911144|E2|Reported Event|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293657|NCT00911144|E1|Reported Event|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
293658|NCT00910988|B5|Baseline|Total|Total of all reporting groups
293659|NCT00910988|B4|Baseline|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
293660|NCT00910988|B3|Baseline|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
293661|NCT00910988|B2|Baseline|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
293662|NCT00910988|B1|Baseline|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
293663|NCT00910988|P4|Participant Flow|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
293664|NCT00910988|P3|Participant Flow|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
293665|NCT00910988|P2|Participant Flow|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
293666|NCT00910988|P1|Participant Flow|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
293667|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
293668|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
293669|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
293670|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
293671|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
293672|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
293673|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
293674|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
293675|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
293676|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
293677|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
293678|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
293679|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
293680|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
293681|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
293851|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293683|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
293684|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
293685|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
293686|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
293687|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
293688|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
293689|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
293690|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
293691|NCT00910988|O8|Outcome|Ziprasidone (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
293692|NCT00910988|O7|Outcome|Ziprasidone (Drug/Placebo)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
293693|NCT00910988|O6|Outcome|Ziprasidone (Placebo/Drug)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
293694|NCT00910988|O5|Outcome|Ziprasidone (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
293695|NCT00910988|O4|Outcome|Olanzapine (Placebo/Drug)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
293696|NCT00910988|O3|Outcome|Olanzapine (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
293697|NCT00910988|O2|Outcome|Olanzapine (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
293698|NCT00910988|O1|Outcome|Olanzapine (Drug/Placebo)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
293699|NCT00910988|E8|Reported Event|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
293700|NCT00910988|E7|Reported Event|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
293701|NCT00910988|E6|Reported Event|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
293702|NCT00910988|E5|Reported Event|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
293703|NCT00910988|E4|Reported Event|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
293704|NCT00910988|E3|Reported Event|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
293705|NCT00910988|E2|Reported Event|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
293706|NCT00910988|E1|Reported Event|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
293707|NCT00910910|B3|Baseline|Total|Total of all reporting groups
293708|NCT00910910|B2|Baseline|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293709|NCT00910910|B1|Baseline|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293710|NCT00910910|P2|Participant Flow|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293711|NCT00910910|P1|Participant Flow|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293712|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293802|NCT00910715|E3|Reported Event|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
293713|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293714|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293715|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293716|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293717|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293718|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293719|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293720|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293721|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293722|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293723|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293724|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293725|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293726|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293788|NCT00910845|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293799|NCT00910715|O3|Outcome|Controls|subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
293727|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293728|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293729|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293730|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293731|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293732|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293733|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293734|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293735|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293736|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293737|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293738|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293739|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293740|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293789|NCT00910845|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293790|NCT00910715|B4|Baseline|Total|Total of all reporting groups
293791|NCT00910715|B3|Baseline|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
293741|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293742|NCT00910910|E2|Reported Event|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
293743|NCT00910910|E1|Reported Event|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
293744|NCT00910871|B1|Baseline|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
293745|NCT00910871|P1|Participant Flow|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
293746|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
293747|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
293748|NCT00910871|E1|Reported Event|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
293749|NCT00910858|B4|Baseline|Total|Total of all reporting groups
293750|NCT00910858|B3|Baseline|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293751|NCT00910858|B2|Baseline|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293752|NCT00910858|B1|Baseline|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293753|NCT00910858|P3|Participant Flow|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293792|NCT00910715|B2|Baseline|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
293793|NCT00910715|B1|Baseline|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
293794|NCT00910715|P3|Participant Flow|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
293754|NCT00910858|P2|Participant Flow|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293755|NCT00910858|P1|Participant Flow|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293756|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293757|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293758|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
293759|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293760|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293761|NCT00910858|O3|Outcome|Overall|All participants in the Safety population.
293762|NCT00910858|O2|Outcome|Non-responders|Participants who were not erythroid responders.
293763|NCT00910858|O1|Outcome|Responders|Participants with a erythroid response.
293764|NCT00910858|O3|Outcome|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293765|NCT00910858|O2|Outcome|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293795|NCT00910715|P2|Participant Flow|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
293796|NCT00910715|P1|Participant Flow|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
293797|NCT00910715|O2|Outcome|Controls|control subjects without a history of Lyme borreliosis
293798|NCT00910715|O1|Outcome|EM Patients|EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
293800|NCT00910715|O2|Outcome|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
293766|NCT00910858|O1|Outcome|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293767|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293768|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293769|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
293770|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
293771|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
293772|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
293773|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
293774|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
293775|NCT00910858|E2|Reported Event|15 mg Lenalidomide|"Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293776|NCT00910858|E1|Reported Event|10 mg Lenalidomide|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
293777|NCT00910845|B3|Baseline|Total|Total of all reporting groups
293778|NCT00910845|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293779|NCT00910845|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293780|NCT00910845|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293781|NCT00910845|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293782|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293783|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293784|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293785|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293786|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293787|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
299906|NCT00888329|E1|Reported Event|Aprepitant|40 mg aprepitant
293806|NCT00910689|B4|Baseline|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293807|NCT00910689|B3|Baseline|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293808|NCT00910689|B2|Baseline|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293809|NCT00910689|B1|Baseline|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293810|NCT00910689|P4|Participant Flow|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293811|NCT00910689|P3|Participant Flow|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293812|NCT00910689|P2|Participant Flow|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293813|NCT00910689|P1|Participant Flow|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293814|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293815|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293816|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293817|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293818|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293819|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293820|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293821|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293822|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293823|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293824|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293825|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293826|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293827|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293828|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293829|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293830|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293831|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293832|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293833|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293834|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
293835|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
293836|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
293837|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
293838|NCT00910689|E4|Reported Event|OAT + BMM + Beta-Blocker at Month 5|"Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5)."
293839|NCT00910689|E3|Reported Event|OAT + BMM + PL at Month 5|"Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5)."
293840|NCT00910689|E2|Reported Event|OAT + Beta-Blocker at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
293841|NCT00910689|E1|Reported Event|OAT + Placebo (PL) at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
293842|NCT00910663|B3|Baseline|Total|Total of all reporting groups
293843|NCT00910663|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
293844|NCT00910663|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
293845|NCT00910663|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
293846|NCT00910663|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
293847|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293848|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
293849|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
293850|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
293852|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
293853|NCT00910663|E2|Reported Event|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
293854|NCT00910663|E1|Reported Event|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
293855|NCT00910624|B5|Baseline|Total|Total of all reporting groups
293856|NCT00910624|B4|Baseline|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293857|NCT00910624|B3|Baseline|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293858|NCT00910624|B2|Baseline|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293859|NCT00910624|B1|Baseline|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293860|NCT00910624|P4|Participant Flow|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293861|NCT00910624|P3|Participant Flow|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293862|NCT00910624|P2|Participant Flow|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293863|NCT00910624|P1|Participant Flow|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293864|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293865|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293866|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293890|NCT00910299|P2|Participant Flow|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
299907|NCT00888238|B1|Baseline|All Patients|All Randomized patients
293867|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293868|NCT00910624|O1|Outcome|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293869|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293870|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293871|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293872|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293873|NCT00910624|E1|Reported Event|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
293874|NCT00910520|B3|Baseline|Total|Total of all reporting groups
293875|NCT00910520|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293876|NCT00910520|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293877|NCT00910520|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293878|NCT00910520|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293879|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293880|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293881|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293882|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293883|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293884|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293885|NCT00910520|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
293886|NCT00910520|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
293887|NCT00910299|B3|Baseline|Total|Total of all reporting groups
293888|NCT00910299|B2|Baseline|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
293889|NCT00910299|B1|Baseline|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
301218|NCT00884039|P1|Participant Flow|30 mg Anecortave Acetate|
293891|NCT00910299|P1|Participant Flow|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
293892|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
293893|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
293894|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
293895|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
293896|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
293897|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
293898|NCT00910299|E2|Reported Event|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
293899|NCT00910299|E1|Reported Event|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
293900|NCT00910273|B3|Baseline|Total|Total of all reporting groups
293901|NCT00910273|B2|Baseline|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293902|NCT00910273|B1|Baseline|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293903|NCT00910273|P2|Participant Flow|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293904|NCT00910273|P1|Participant Flow|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293905|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293906|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293907|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293908|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293909|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293910|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293911|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293912|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293913|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293914|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293915|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293916|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293917|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293918|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293919|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293920|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293921|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293922|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293923|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293924|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293925|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293926|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293927|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293928|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293929|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293930|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293931|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293932|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293933|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293934|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293935|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293936|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293937|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293938|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293939|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293940|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
301219|NCT00884039|O2|Outcome|15 mg Anecortave Acetate|
293941|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293942|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293943|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293944|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293945|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293946|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293947|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293948|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293949|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293950|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293951|NCT00910273|E2|Reported Event|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
293952|NCT00910273|E1|Reported Event|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
293953|NCT00910091|B3|Baseline|Total|Total of all reporting groups
293954|NCT00910091|B2|Baseline|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293955|NCT00910091|B1|Baseline|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293956|NCT00910091|P2|Participant Flow|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
293957|NCT00910091|P1|Participant Flow|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293958|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293959|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293960|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293961|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293962|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293963|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293964|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293965|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293966|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293967|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293968|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293969|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293970|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293971|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293972|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293973|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293974|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293975|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293976|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293977|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293978|NCT00910091|O2|Outcome|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
293979|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293980|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
293981|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
293982|NCT00910091|E2|Reported Event|B- MA - 160mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~Megestrol Acetate (MA): MA will be administered orally as 160mg daily"
293983|NCT00910091|E1|Reported Event|A- BN 83495- 40mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~BN83495: BN83495 will be administered as a 40 mg tablet once a day orally"
293984|NCT00910039|B1|Baseline|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293985|NCT00910039|P1|Participant Flow|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293986|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
294050|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
293987|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293988|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293989|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293990|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293991|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293992|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293993|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293994|NCT00910039|E1|Reported Event|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
293995|NCT00910000|B7|Baseline|Total|Total of all reporting groups
293996|NCT00910000|B6|Baseline|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
293997|NCT00910000|B5|Baseline|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
293998|NCT00910000|B4|Baseline|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
293999|NCT00910000|B3|Baseline|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294000|NCT00910000|B2|Baseline|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294001|NCT00910000|B1|Baseline|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294002|NCT00910000|P6|Participant Flow|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294003|NCT00910000|P5|Participant Flow|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294004|NCT00910000|P4|Participant Flow|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294005|NCT00910000|P3|Participant Flow|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294006|NCT00910000|P2|Participant Flow|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294007|NCT00910000|P1|Participant Flow|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294008|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294009|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294010|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294011|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294012|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294013|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294014|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294015|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294016|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294017|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294018|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294051|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
301220|NCT00884039|O1|Outcome|30 mg Anecortave Acetate|
294019|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294020|NCT00910000|O1|Outcome|All Phase Ib Participants|"All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9).~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
294021|NCT00910000|E1|Reported Event|All Phase Ib Participants|All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9). Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
294022|NCT00909870|B3|Baseline|Total|Total of all reporting groups
294023|NCT00909870|B2|Baseline|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294024|NCT00909870|B1|Baseline|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294025|NCT00909870|P2|Participant Flow|Active Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294026|NCT00909870|P1|Participant Flow|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294027|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294028|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294029|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294030|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of=- Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294031|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294032|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294033|NCT00909870|E2|Reported Event|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
294034|NCT00909870|E1|Reported Event|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
294035|NCT00909857|B3|Baseline|Total|Total of all reporting groups
294036|NCT00909857|B2|Baseline|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294037|NCT00909857|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294038|NCT00909857|P2|Participant Flow|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294039|NCT00909857|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294040|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294041|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294042|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294043|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294044|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294045|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294046|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294047|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294048|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294049|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
301221|NCT00884039|E2|Reported Event|15 mg Anecortave Acetate|
294052|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294053|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294054|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294055|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294056|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294057|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294058|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294059|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294060|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294061|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294062|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294063|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294064|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294065|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294066|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294067|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294068|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294069|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294070|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294071|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294072|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294073|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294074|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294075|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294076|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294077|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294078|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294079|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294080|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294081|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294256|NCT00909610|B2|Baseline|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
294082|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294083|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294084|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294085|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294086|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294087|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294088|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294089|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294090|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294091|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294092|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294093|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294094|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294095|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294096|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294097|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294098|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294099|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294100|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294101|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294102|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294103|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294104|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294105|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294106|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294107|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294108|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294109|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294110|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294111|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294257|NCT00909610|B1|Baseline|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
294112|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294113|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294114|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294115|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294116|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294117|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294118|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294119|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294120|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294121|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294122|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294123|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294124|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294125|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294126|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294127|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294128|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294129|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294130|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294131|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294132|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294133|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294134|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294135|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294136|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294137|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294138|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294139|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294140|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294141|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294320|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294321|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294142|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294143|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294144|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294145|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294146|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294147|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294148|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294149|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294150|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294151|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294152|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294153|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294154|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294155|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294156|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294157|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294158|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294159|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294160|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294161|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294162|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294163|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294164|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294165|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294166|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294167|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294168|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294169|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294170|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294171|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294322|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
301222|NCT00884039|E1|Reported Event|30 mg Anecortave Acetate|
294172|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294173|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294174|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294175|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294176|NCT00909857|E2|Reported Event|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
294177|NCT00909857|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
294178|NCT00909792|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
294179|NCT00909792|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
294180|NCT00909792|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
294181|NCT00909792|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
294182|NCT00909792|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
294183|NCT00909792|E2|Reported Event|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
294184|NCT00909792|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
294185|NCT00909779|B3|Baseline|Total|Total of all reporting groups
294186|NCT00909779|B2|Baseline|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294187|NCT00909779|B1|Baseline|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294188|NCT00909779|P2|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294189|NCT00909779|P1|Participant Flow|Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294190|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294191|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294192|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294193|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294194|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294195|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294196|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294197|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294198|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294199|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294200|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294201|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294323|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294202|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294203|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294204|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294205|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
294206|NCT00909779|O2|Outcome|Placebo|Placebo twice daily
294207|NCT00909779|O1|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294208|NCT00909779|E2|Reported Event|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294209|NCT00909779|E1|Reported Event|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
294210|NCT00909753|B3|Baseline|Total|Total of all reporting groups
294211|NCT00909753|B2|Baseline|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
294212|NCT00909753|B1|Baseline|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
294213|NCT00909753|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
294214|NCT00909753|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
294215|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294216|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294217|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294218|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294219|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294220|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294221|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294222|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294223|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294224|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294225|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294226|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294227|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294228|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294229|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
294230|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
294231|NCT00909727|B3|Baseline|Total|Total of all reporting groups
294232|NCT00909727|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294233|NCT00909727|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294234|NCT00909727|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294235|NCT00909727|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294236|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294237|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294238|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294239|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294240|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294241|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294242|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294243|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294244|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294245|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294246|NCT00909727|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
294247|NCT00909727|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
294248|NCT00909649|B3|Baseline|Total|Total of all reporting groups
294249|NCT00909649|B2|Baseline|Non Fibrin Group|
294250|NCT00909649|B1|Baseline|Fibrin Group|
294251|NCT00909649|P2|Participant Flow|Non Fibrin Group|
294252|NCT00909649|P1|Participant Flow|Fibrin Group|
294253|NCT00909649|O2|Outcome|Non Fibrin Group|
294254|NCT00909649|O1|Outcome|Fibrin Group|
294255|NCT00909610|B3|Baseline|Total|Total of all reporting groups
294258|NCT00909610|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
294259|NCT00909610|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
294260|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294261|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294262|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294263|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294264|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294265|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294266|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294267|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294268|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294269|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294270|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294271|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294272|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294273|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
294274|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
294275|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period
294276|NCT00909545|B5|Baseline|Total|Total of all reporting groups
294277|NCT00909545|B4|Baseline|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294278|NCT00909545|B3|Baseline|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294279|NCT00909545|B2|Baseline|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294280|NCT00909545|B1|Baseline|Placebo|4 Placebo to Match (PTM) tablets once daily
294281|NCT00909545|P4|Participant Flow|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
294282|NCT00909545|P3|Participant Flow|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294283|NCT00909545|P2|Participant Flow|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294284|NCT00909545|P1|Participant Flow|Placebo|4 Placebo to Match (PTM) tablets once daily
294285|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294286|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294287|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294288|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294289|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294290|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294291|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294292|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294293|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294294|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294295|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294296|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294297|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294298|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294299|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294300|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294301|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294302|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294303|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294304|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294305|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294306|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294307|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294308|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294309|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294310|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294311|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294312|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294313|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294314|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294315|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294316|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294317|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294318|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294319|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294324|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294325|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294326|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294327|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294328|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294329|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294330|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294331|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294332|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294333|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294334|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294335|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294336|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294337|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294338|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294339|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294340|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294341|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294342|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294343|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294344|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294345|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294346|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294347|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294348|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294349|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294350|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294351|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294352|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294353|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294354|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294355|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294356|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294357|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294358|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294359|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294360|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294361|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294362|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294363|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294364|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294365|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294366|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294367|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294368|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294369|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294370|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294371|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294372|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294373|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294374|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294375|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294376|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294377|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294378|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294379|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294380|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294381|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294382|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294383|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294384|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294385|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294386|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294387|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294388|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294389|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294390|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294391|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294392|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294393|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294394|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294395|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294396|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294397|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294398|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294399|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294400|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294401|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294402|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294403|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294404|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294405|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294406|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294407|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294408|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294409|NCT00909545|O4|Outcome|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
294410|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294411|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294412|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
294413|NCT00909545|E4|Reported Event|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
294414|NCT00909545|E3|Reported Event|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
294415|NCT00909545|E2|Reported Event|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
294416|NCT00909545|E1|Reported Event|Placebo|4 Placebo to Match (PTM) tablets once daily
294417|NCT00909532|B3|Baseline|Total|Total of all reporting groups
294418|NCT00909532|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294419|NCT00909532|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294420|NCT00909532|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294421|NCT00909532|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294422|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294423|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294424|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294425|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294426|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294427|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294428|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294429|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294430|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablets of 150 mg of ivacaftor q12h for up to 48 weeks.
294431|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294432|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294433|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294434|NCT00909532|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
294435|NCT00909532|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
294436|NCT00909480|B3|Baseline|Total|Total of all reporting groups
294437|NCT00909480|B2|Baseline|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294438|NCT00909480|B1|Baseline|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294439|NCT00909480|P2|Participant Flow|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294440|NCT00909480|P1|Participant Flow|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294441|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294442|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294443|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294444|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294445|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294446|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294447|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294448|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294449|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294450|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
301223|NCT00883779|B3|Baseline|Total|Total of all reporting groups
294451|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294452|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294453|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294454|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294455|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294456|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294457|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294458|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294459|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294460|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294461|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294462|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294463|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294464|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294465|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294466|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294467|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294468|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294469|NCT00909480|E2|Reported Event|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
294470|NCT00909480|E1|Reported Event|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
294471|NCT00909389|B1|Baseline|Filipino Patients With Hypercholesterolemia|
294472|NCT00909389|P1|Participant Flow|Filipino Patients With Hypercholesterolemia|
294473|NCT00909389|O1|Outcome|Filipino Patients With Hypercholesterolemia|
294474|NCT00909389|E1|Reported Event|Filipino Patients With Hypercholesterolemia|
294475|NCT00909324|B3|Baseline|Total|Total of all reporting groups
294476|NCT00909324|B2|Baseline|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294477|NCT00909324|B1|Baseline|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294478|NCT00909324|P2|Participant Flow|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294479|NCT00909324|P1|Participant Flow|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294480|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294481|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294482|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294483|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294484|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294485|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294486|NCT00909324|E2|Reported Event|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
294487|NCT00909324|E1|Reported Event|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
294488|NCT00909181|B4|Baseline|Total|Total of all reporting groups
294489|NCT00909181|B3|Baseline|Placebo Gel|
294490|NCT00909181|B2|Baseline|Oxybutynin Gel 84 mg/Day|
294491|NCT00909181|B1|Baseline|Oxybutynin Gel 56 mg/Day|
294492|NCT00909181|P3|Participant Flow|Placebo Gel|
294493|NCT00909181|P2|Participant Flow|Oxybutynin Gel 84 mg/Day|
294494|NCT00909181|P1|Participant Flow|Oxybutynin Gel 56 mg/Day|
294495|NCT00909181|O3|Outcome|Placebo Gel|
294496|NCT00909181|O2|Outcome|Oxybutynin Gel 84 mg/Day|
294497|NCT00909181|O1|Outcome|Oxybutynin Gel 56 mg/Day|
294498|NCT00909181|E3|Reported Event|Placebo Gel|
294499|NCT00909181|E2|Reported Event|Oxybutynin Gel 84 mg/Day|
294500|NCT00909181|E1|Reported Event|Oxybutynin Gel 56 mg/Day|
294501|NCT00909155|B4|Baseline|Total|Total of all reporting groups
294502|NCT00909155|B3|Baseline|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
295136|NCT00907335|B1|Baseline|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
294503|NCT00909155|B2|Baseline|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
294504|NCT00909155|B1|Baseline|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
294505|NCT00909155|P3|Participant Flow|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
294506|NCT00909155|P2|Participant Flow|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
294507|NCT00909155|P1|Participant Flow|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
294508|NCT00909155|O3|Outcome|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
294509|NCT00909155|O2|Outcome|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
294510|NCT00909155|O1|Outcome|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
294511|NCT00909155|E3|Reported Event|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
294512|NCT00909155|E2|Reported Event|Currently Depressed Subjects; Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
294513|NCT00909155|E1|Reported Event|Currently Depressed Subjects; Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
294514|NCT00909038|B1|Baseline|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294515|NCT00909038|P1|Participant Flow|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294516|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294517|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294518|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294519|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294520|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294521|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294522|NCT00909038|E1|Reported Event|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
294523|NCT00908960|B4|Baseline|Total|Total of all reporting groups
294524|NCT00908960|B3|Baseline|Arm C (Low TFMP)|Observation
294525|NCT00908960|B2|Baseline|Arm B (High TFMP)|Observation
294526|NCT00908960|B1|Baseline|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
294527|NCT00908960|P3|Participant Flow|Arm C (Low TFMP)|Observation
294528|NCT00908960|P2|Participant Flow|Arm B (High TFMP)|Observation
294529|NCT00908960|P1|Participant Flow|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
294530|NCT00908960|O3|Outcome|Arm C (Low TFMP)|Observation
294531|NCT00908960|O2|Outcome|Arm B (High TFMP)|Observation
294532|NCT00908960|O1|Outcome|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
294533|NCT00908960|E3|Reported Event|Arm C (Low TFMP)|Observation
294534|NCT00908960|E2|Reported Event|Arm B (High TFMP)|Observation
294535|NCT00908960|E1|Reported Event|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
294536|NCT00908908|B1|Baseline|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
304366|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
294537|NCT00908908|P1|Participant Flow|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
294538|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
294539|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
294540|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
294541|NCT00908908|E1|Reported Event|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
294542|NCT00908895|B3|Baseline|Total|Total of all reporting groups
294543|NCT00908895|B2|Baseline|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
294544|NCT00908895|B1|Baseline|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
294545|NCT00908895|P2|Participant Flow|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
294546|NCT00908895|P1|Participant Flow|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
294547|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
294548|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
294549|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
294550|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
294551|NCT00908895|E2|Reported Event|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
294552|NCT00908895|E1|Reported Event|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
294553|NCT00908882|B3|Baseline|Total|Total of all reporting groups
294554|NCT00908882|B2|Baseline|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294555|NCT00908882|B1|Baseline|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294556|NCT00908882|P2|Participant Flow|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294557|NCT00908882|P1|Participant Flow|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294558|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294559|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294560|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294561|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294562|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294563|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294564|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294565|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294566|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294957|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294567|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294568|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294569|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294570|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294571|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294572|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294573|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294574|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294575|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294576|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
294577|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294578|NCT00908882|E2|Reported Event|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy
294579|NCT00908882|E1|Reported Event|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
294580|NCT00908687|B7|Baseline|Total|Total of all reporting groups
294581|NCT00908687|B6|Baseline|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294582|NCT00908687|B5|Baseline|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294583|NCT00908687|B4|Baseline|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
294584|NCT00908687|B3|Baseline|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294585|NCT00908687|B2|Baseline|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294586|NCT00908687|B1|Baseline|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
294587|NCT00908687|P6|Participant Flow|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294588|NCT00908687|P5|Participant Flow|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294589|NCT00908687|P4|Participant Flow|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
294590|NCT00908687|P3|Participant Flow|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294591|NCT00908687|P2|Participant Flow|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294592|NCT00908687|P1|Participant Flow|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
295132|NCT00907374|E2|Reported Event|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
294593|NCT00908687|O6|Outcome|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294594|NCT00908687|O5|Outcome|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294595|NCT00908687|O4|Outcome|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
294596|NCT00908687|O3|Outcome|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294597|NCT00908687|O2|Outcome|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294598|NCT00908687|O1|Outcome|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
294599|NCT00908687|E6|Reported Event|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294600|NCT00908687|E5|Reported Event|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294601|NCT00908687|E4|Reported Event|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
294602|NCT00908687|E3|Reported Event|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
294603|NCT00908687|E2|Reported Event|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
294604|NCT00908687|E1|Reported Event|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
294605|NCT00908648|B3|Baseline|Total|Total of all reporting groups
294606|NCT00908648|B2|Baseline|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
294607|NCT00908648|B1|Baseline|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
294608|NCT00908648|P2|Participant Flow|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
294609|NCT00908648|P1|Participant Flow|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
294610|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
294611|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
294612|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
294613|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
294614|NCT00908596|B5|Baseline|Total|Total of all reporting groups
294615|NCT00908596|B4|Baseline|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294616|NCT00908596|B3|Baseline|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294617|NCT00908596|B2|Baseline|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294618|NCT00908596|B1|Baseline|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294619|NCT00908596|P4|Participant Flow|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294620|NCT00908596|P3|Participant Flow|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294621|NCT00908596|P2|Participant Flow|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294622|NCT00908596|P1|Participant Flow|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294623|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294624|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294625|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294626|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294627|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
304367|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
294628|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294629|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294630|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294631|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294632|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294633|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294634|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294635|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294636|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294637|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294638|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294639|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294640|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294641|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294642|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294643|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294644|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294645|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294646|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294647|NCT00908596|E4|Reported Event|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294648|NCT00908596|E3|Reported Event|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294649|NCT00908596|E2|Reported Event|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294650|NCT00908596|E1|Reported Event|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
294651|NCT00908583|B1|Baseline|All Study Participants|Combined study participants, all phases.
294652|NCT00908583|P1|Participant Flow|All Study Participants|Combined study participants all phases.
294653|NCT00908583|O1|Outcome|All Transplanted Participants|Combined phases, transplanted patients.
294654|NCT00908583|O1|Outcome|All Study Participants|All study participants combined.4 participants were enrolled in multiple groups or phases. They are only counted once.
294655|NCT00908583|O1|Outcome|All Study Participants|All study participants combined. Counting participants only once even though 7 participants were enrolled in multiple phases.
294656|NCT00908583|O8|Outcome|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
304368|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
294657|NCT00908583|O7|Outcome|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294658|NCT00908583|O6|Outcome|Phase 3, Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294659|NCT00908583|O5|Outcome|Phase 3, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294660|NCT00908583|O4|Outcome|Phase 2 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294661|NCT00908583|O3|Outcome|Phase 2, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294662|NCT00908583|O2|Outcome|Phase 1 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294663|NCT00908583|O1|Outcome|Phase 1, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294664|NCT00908583|E5|Reported Event|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294665|NCT00908583|E4|Reported Event|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294666|NCT00908583|E3|Reported Event|Phase 3|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294667|NCT00908583|E2|Reported Event|Phase 2, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294668|NCT00908583|E1|Reported Event|Phase 1, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
294669|NCT00908388|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
294670|NCT00908388|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294671|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294672|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294673|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294674|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294675|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294676|NCT00908388|E1|Reported Event|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
294677|NCT00908375|B3|Baseline|Total|Total of all reporting groups
294678|NCT00908375|B2|Baseline|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294679|NCT00908375|B1|Baseline|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294680|NCT00908375|P2|Participant Flow|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294681|NCT00908375|P1|Participant Flow|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294723|NCT00908128|B2|Baseline|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
304369|NCT00875420|E5|Reported Event|Placebo|Oral once a day for 28 days
294682|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294683|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294684|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294685|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294686|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294687|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294688|NCT00908375|E2|Reported Event|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
294689|NCT00908375|E1|Reported Event|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
294690|NCT00908310|B1|Baseline|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
294691|NCT00908310|P1|Participant Flow|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
294692|NCT00908310|O1|Outcome|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
294693|NCT00908310|E1|Reported Event|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
294694|NCT00908232|B1|Baseline|All Study Participants|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
294695|NCT00908232|P4|Participant Flow|SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294696|NCT00908232|P3|Participant Flow|SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
294697|NCT00908232|P2|Participant Flow|Stable Disease: Bortezomib + Dexamethasone (VD)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294698|NCT00908232|P1|Participant Flow|Cycle 1 to 4: Bortezomib + Dexamethasone (VD)|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
294699|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294700|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294724|NCT00908128|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294701|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294702|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294703|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294704|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294705|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294706|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294707|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294708|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294709|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294710|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294711|NCT00908232|E2|Reported Event|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
294712|NCT00908232|E1|Reported Event|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
294713|NCT00908141|B3|Baseline|Total|Total of all reporting groups
294714|NCT00908141|B2|Baseline|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
294715|NCT00908141|B1|Baseline|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
294716|NCT00908141|P2|Participant Flow|Group B:Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
294717|NCT00908141|P1|Participant Flow|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
294718|NCT00908141|O2|Outcome|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
294719|NCT00908141|O1|Outcome|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
294720|NCT00908141|E2|Reported Event|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
294721|NCT00908141|E1|Reported Event|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
294722|NCT00908128|B3|Baseline|Total|Total of all reporting groups
294958|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294725|NCT00908128|P2|Participant Flow|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294726|NCT00908128|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294727|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
294728|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
294729|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
294730|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
294731|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
294732|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
294733|NCT00908115|B1|Baseline|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294734|NCT00908115|P1|Participant Flow|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294735|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294736|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294737|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294738|NCT00908115|E1|Reported Event|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
294739|NCT00908076|B3|Baseline|Total|Total of all reporting groups
294740|NCT00908076|B2|Baseline|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294741|NCT00908076|B1|Baseline|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294742|NCT00908076|P2|Participant Flow|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294743|NCT00908076|P1|Participant Flow|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294744|NCT00908076|O2|Outcome|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294745|NCT00908076|O1|Outcome|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294746|NCT00908076|E2|Reported Event|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294747|NCT00908076|E1|Reported Event|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
294748|NCT00908037|B8|Baseline|Total|Total of all reporting groups
294749|NCT00908037|B7|Baseline|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
294750|NCT00908037|B6|Baseline|Part 2 (Randomized Period) Cohort 3-Placebo|Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294751|NCT00908037|B5|Baseline|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
294752|NCT00908037|B4|Baseline|Part 2 (Randomized Period) Cohort 2-Placebo|Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
294753|NCT00908037|B3|Baseline|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
294754|NCT00908037|B2|Baseline|Part 2 (Randomized Period) Cohort 1-Placebo|Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
294755|NCT00908037|B1|Baseline|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
294756|NCT00908037|P12|Participant Flow|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294757|NCT00908037|P11|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294758|NCT00908037|P10|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294759|NCT00908037|P9|Participant Flow|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294760|NCT00908037|P8|Participant Flow|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294761|NCT00908037|P7|Participant Flow|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294762|NCT00908037|P6|Participant Flow|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294763|NCT00908037|P5|Participant Flow|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
297653|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
294764|NCT00908037|P4|Participant Flow|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294765|NCT00908037|P3|Participant Flow|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294766|NCT00908037|P2|Participant Flow|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294767|NCT00908037|P1|Participant Flow|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294768|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294769|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294770|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294771|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294772|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294773|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294774|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294789|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
294775|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294776|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294777|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294778|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294779|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294780|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294781|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294782|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294783|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294784|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294785|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294786|NCT00908037|O1|Outcome|Part 2/ 3 Eltrombopag Open-Label Period|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
294787|NCT00908037|O2|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294788|NCT00908037|O1|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo QD for 7 weeks.
294959|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
298202|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
294790|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294791|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294792|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294793|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294794|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294795|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294796|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294797|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294798|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294799|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294800|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294801|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294802|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294960|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294961|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294962|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
298203|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
294803|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294804|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294805|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294806|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294807|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294808|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294809|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294810|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294811|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294812|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294813|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294814|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
294815|NCT00908037|O3|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294816|NCT00908037|O2|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294963|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294964|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294817|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
294818|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294819|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294820|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294821|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294822|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294823|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294824|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294825|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294826|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294827|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294828|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294829|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294965|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294966|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
298204|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
294830|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
294831|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
294832|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294833|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
294834|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
294835|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294836|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294837|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
294838|NCT00908037|O4|Outcome|Part 2/3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
294839|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294840|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294853|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294841|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a body weight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
294842|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294843|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294844|NCT00908037|O1|Outcome|Part 2/ 3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294845|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294846|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294847|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294848|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294849|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294850|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294851|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294852|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294967|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294968|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294854|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294855|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294856|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294857|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294858|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294859|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294860|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294861|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294862|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294863|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294864|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294865|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294866|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294879|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
295133|NCT00907374|E1|Reported Event|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
294867|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294868|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294869|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294870|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294871|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294872|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294873|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294874|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294875|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294876|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294877|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294878|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294880|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294881|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294882|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294883|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294884|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294885|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294886|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294887|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294896|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294969|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294970|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294971|NCT00907803|E3|Reported Event|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294888|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294889|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294890|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294891|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294892|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
294893|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294894|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of &lt;=27 kg received 25 mg QD and participants with a body weight of &gt;=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294895|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294952|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294953|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294897|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294898|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294899|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294900|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294901|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294902|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294903|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294904|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
294905|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294906|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294907|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
294908|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
294909|NCT00908037|E4|Reported Event|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
294910|NCT00908037|E3|Reported Event|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of &lt;27 kg received 25 mg QD, and par with a body weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD, and with a body weight of &gt;=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
294911|NCT00908037|E2|Reported Event|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
294954|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294955|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294956|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294912|NCT00908037|E1|Reported Event|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight &lt;27 kg: 25 mg QD, Weight &gt;=27 kg: 50 mg QD; east Asian ancestry subjects Weight &lt;27 kg: 12.5 mg QD, Weight &gt;=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
294913|NCT00908011|B3|Baseline|Total|Total of all reporting groups
294914|NCT00908011|B2|Baseline|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
294915|NCT00908011|B1|Baseline|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
294916|NCT00908011|P2|Participant Flow|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
294917|NCT00908011|P1|Participant Flow|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
294918|NCT00908011|O2|Outcome|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
294919|NCT00908011|O1|Outcome|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
294920|NCT00908011|E2|Reported Event|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
294921|NCT00908011|E1|Reported Event|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
294922|NCT00907907|B3|Baseline|Total|Total of all reporting groups
294923|NCT00907907|B2|Baseline|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294924|NCT00907907|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294925|NCT00907907|P2|Participant Flow|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294926|NCT00907907|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
294927|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
294928|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
294929|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
294930|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
294931|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
294932|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
294933|NCT00907881|B1|Baseline|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294934|NCT00907881|P1|Participant Flow|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294935|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294936|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294937|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294938|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
294939|NCT00907881|E1|Reported Event|All Participants|
294940|NCT00907803|B4|Baseline|Total|Total of all reporting groups
294941|NCT00907803|B3|Baseline|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294942|NCT00907803|B2|Baseline|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294943|NCT00907803|B1|Baseline|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294944|NCT00907803|P3|Participant Flow|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294945|NCT00907803|P2|Participant Flow|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294946|NCT00907803|P1|Participant Flow|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294947|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294948|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294949|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294950|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
294951|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294972|NCT00907803|E2|Reported Event|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
294973|NCT00907803|E1|Reported Event|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
294974|NCT00907777|B3|Baseline|Total|Total of all reporting groups
294975|NCT00907777|B2|Baseline|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294976|NCT00907777|B1|Baseline|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294977|NCT00907777|P2|Participant Flow|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294978|NCT00907777|P1|Participant Flow|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294979|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294980|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294981|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294982|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294983|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294984|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294985|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294986|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294987|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294988|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294989|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294990|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
295098|NCT00907478|E1|Reported Event|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295099|NCT00907426|B4|Baseline|Total|Total of all reporting groups
295134|NCT00907335|B3|Baseline|Total|Total of all reporting groups
294991|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294992|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294993|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294994|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294995|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294996|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294997|NCT00907777|E2|Reported Event|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294998|NCT00907777|E1|Reported Event|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
294999|NCT00907738|B6|Baseline|Total|Total of all reporting groups
295000|NCT00907738|B5|Baseline|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
295001|NCT00907738|B4|Baseline|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
295002|NCT00907738|B3|Baseline|Base Protocol 008|vorinostat 400 mg QD
295003|NCT00907738|B2|Baseline|Base Protocol 006|vorinostat 200 mg twice daily (BID)
295004|NCT00907738|B1|Baseline|Base Protocol 001|Vorinostat 400 mg daily (QD)
295005|NCT00907738|P5|Participant Flow|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
295006|NCT00907738|P4|Participant Flow|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
295007|NCT00907738|P3|Participant Flow|Base Protocol 008|vorinostat 400 mg QD
295008|NCT00907738|P2|Participant Flow|Base Protocol 006|vorinostat 200 mg twice daily (BID)
295009|NCT00907738|P1|Participant Flow|Base Protocol 001|Vorinostat 400 mg daily (QD)
295010|NCT00907738|O5|Outcome|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
295011|NCT00907738|O4|Outcome|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
295012|NCT00907738|O3|Outcome|Base Protocol 008|vorinostat 400 mg QD
295013|NCT00907738|O2|Outcome|Base Protocol 006|vorinostat 200 mg twice daily (BID)
295014|NCT00907738|O1|Outcome|Base Protocol 001|Vorinostat 400 mg daily (QD)
295015|NCT00907738|E9|Reported Event|Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
295016|NCT00907738|E8|Reported Event|Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)|
295017|NCT00907738|E7|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)|
295018|NCT00907738|E6|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)|
295019|NCT00907738|E5|Reported Event|Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
295020|NCT00907738|E4|Reported Event|Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)|
295021|NCT00907738|E3|Reported Event|Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])|
295022|NCT00907738|E2|Reported Event|Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])|
295023|NCT00907738|E1|Reported Event|Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])|
295024|NCT00907621|B3|Baseline|Total|Total of all reporting groups
295128|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295135|NCT00907335|B2|Baseline|Vehicle Control|Color matched facial gel vehicle control used once daily
295025|NCT00907621|B2|Baseline|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
295026|NCT00907621|B1|Baseline|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
295027|NCT00907621|P2|Participant Flow|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
295028|NCT00907621|P1|Participant Flow|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
295029|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
295030|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
295031|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
295032|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
295033|NCT00907621|E2|Reported Event|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
295034|NCT00907621|E1|Reported Event|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
295035|NCT00907517|B6|Baseline|Total|Total of all reporting groups
295036|NCT00907517|B5|Baseline|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295037|NCT00907517|B4|Baseline|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295038|NCT00907517|B3|Baseline|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295039|NCT00907517|B2|Baseline|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295040|NCT00907517|B1|Baseline|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295129|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295130|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295041|NCT00907517|P5|Participant Flow|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295042|NCT00907517|P4|Participant Flow|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295043|NCT00907517|P3|Participant Flow|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295044|NCT00907517|P2|Participant Flow|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295045|NCT00907517|P1|Participant Flow|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295046|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295047|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295048|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295049|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295050|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295051|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295052|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295053|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295054|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295055|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295056|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295057|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295058|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295059|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295131|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295060|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295061|NCT00907517|E5|Reported Event|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295062|NCT00907517|E4|Reported Event|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295063|NCT00907517|E3|Reported Event|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295064|NCT00907517|E2|Reported Event|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295065|NCT00907517|E1|Reported Event|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
295066|NCT00907478|B4|Baseline|Total|Total of all reporting groups
295067|NCT00907478|B3|Baseline|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295068|NCT00907478|B2|Baseline|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295069|NCT00907478|B1|Baseline|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295070|NCT00907478|P3|Participant Flow|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295071|NCT00907478|P2|Participant Flow|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295072|NCT00907478|P1|Participant Flow|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295073|NCT00907478|O1|Outcome|Romiplostim|Participants received once weekly romiplostim for 3 years.
295074|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295075|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295076|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295077|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295078|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295079|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295080|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295081|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295082|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295083|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295084|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295085|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295086|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295087|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295088|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295089|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295090|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295091|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295092|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295093|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295094|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
295095|NCT00907478|E4|Reported Event|Overall|Participants received once weekly romiplostim for 3 years.
295096|NCT00907478|E3|Reported Event|Cohort 3|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
295097|NCT00907478|E2|Reported Event|Cohort 2|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
295100|NCT00907426|B3|Baseline|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295101|NCT00907426|B2|Baseline|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295102|NCT00907426|B1|Baseline|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295103|NCT00907426|P3|Participant Flow|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295104|NCT00907426|P2|Participant Flow|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295105|NCT00907426|P1|Participant Flow|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295106|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295107|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295108|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295109|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295110|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295111|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295112|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295113|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295114|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295115|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
295116|NCT00907426|E3|Reported Event|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295117|NCT00907426|E2|Reported Event|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295118|NCT00907426|E1|Reported Event|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
295119|NCT00907374|B3|Baseline|Total|Total of all reporting groups
295120|NCT00907374|B2|Baseline|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295121|NCT00907374|B1|Baseline|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295122|NCT00907374|P2|Participant Flow|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295123|NCT00907374|P1|Participant Flow|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295124|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295125|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295126|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
295127|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
295137|NCT00907335|P2|Participant Flow|Vehicle Control|Color matched facial gel vehicle control used once daily
295138|NCT00907335|P1|Participant Flow|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295139|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295140|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295141|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295142|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295143|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295144|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295145|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295146|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295147|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295148|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295149|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
295150|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295151|NCT00907335|E2|Reported Event|Vehicle Control|Color matched facial gel vehicle control used once daily
295152|NCT00907335|E1|Reported Event|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
295153|NCT00907257|B3|Baseline|Total|Total of all reporting groups
295154|NCT00907257|B2|Baseline|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295155|NCT00907257|B1|Baseline|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295156|NCT00907257|P2|Participant Flow|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295157|NCT00907257|P1|Participant Flow|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295158|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295159|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295160|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295161|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295162|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295163|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295164|NCT00907257|E2|Reported Event|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
295165|NCT00907257|E1|Reported Event|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
295166|NCT00907218|B1|Baseline|No Data Was Analyzed|
295167|NCT00907218|P1|Participant Flow|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
295168|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|
295169|NCT00907218|E1|Reported Event|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
295170|NCT00907101|B1|Baseline|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295171|NCT00907101|P1|Participant Flow|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295172|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295173|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295174|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295175|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295176|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295177|NCT00907101|E1|Reported Event|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
295178|NCT00907088|B3|Baseline|Total|Total of all reporting groups
295233|NCT00906698|P5|Participant Flow|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295179|NCT00907088|B2|Baseline|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
295180|NCT00907088|B1|Baseline|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
295181|NCT00907088|P2|Participant Flow|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
295182|NCT00907088|P1|Participant Flow|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
295183|NCT00907088|O2|Outcome|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
295184|NCT00907088|O1|Outcome|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
295185|NCT00907088|E2|Reported Event|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
295186|NCT00907088|E1|Reported Event|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
295187|NCT00906971|B3|Baseline|Total|Total of all reporting groups
295188|NCT00906971|B2|Baseline|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
295189|NCT00906971|B1|Baseline|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
295190|NCT00906971|P2|Participant Flow|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
295191|NCT00906971|P1|Participant Flow|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
295192|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
295193|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
295194|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
295195|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
295196|NCT00906971|E2|Reported Event|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
295197|NCT00906971|E1|Reported Event|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
295198|NCT00906789|B1|Baseline|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard CAD Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested"
295341|NCT00906399|P5|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
295199|NCT00906789|P1|Participant Flow|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard and SoftView Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, Two types of software are tested: SoftView (TM). SoftView decreases the visibility of the ribs and clavicles on chest radiographs. OnGuard marks locations on chest radiographs meeting some of the software signs of lung nodules, a method often called Computer Aided Detection (CADe)."
295200|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
295201|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
295202|NCT00906789|O1|Outcome|Radiologists Using OnGuard Software: Difference of 1.0 and 5.1|Radiologists using OnGuard software. Two different versions were tested. OnGuard 1.0 and OnGuard 5.1. This software uses a computer algorithm to identify non-calcified lung nodules consistent with lung cancer. The value presented is the average difference in the areas under the LROC curve as demonstrated for the participating radiologists. The value for OnGuard 5.1 was subtracted from that of OnGuard 1.0, so a negative value indicates that OnGuard 5.1 had a higher value than OnGuard 1.0. The 95% confidence interval indicates that the OnGuard 5.1 was significantly improved.
295203|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
295204|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
295205|NCT00906789|E1|Reported Event|Participants|The 15 radiologists who participated
295206|NCT00906776|B3|Baseline|Total|Total of all reporting groups
295207|NCT00906776|B2|Baseline|Autogenous Bone|Autogenous bone from the patient
295208|NCT00906776|B1|Baseline|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295209|NCT00906776|P2|Participant Flow|Autogenous Bone|Autogenous bone from the patient
295210|NCT00906776|P1|Participant Flow|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295211|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295212|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295213|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295214|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295215|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295216|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295217|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295218|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295219|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295220|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295221|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
295222|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295223|NCT00906776|E2|Reported Event|Autogenous Bone|Autogenous bone from the patient
295224|NCT00906776|E1|Reported Event|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
295225|NCT00906698|B7|Baseline|Total|Total of all reporting groups
295226|NCT00906698|B6|Baseline|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295227|NCT00906698|B5|Baseline|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295228|NCT00906698|B4|Baseline|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295229|NCT00906698|B3|Baseline|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295230|NCT00906698|B2|Baseline|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295231|NCT00906698|B1|Baseline|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295232|NCT00906698|P6|Participant Flow|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295376|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295234|NCT00906698|P4|Participant Flow|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295235|NCT00906698|P3|Participant Flow|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295236|NCT00906698|P2|Participant Flow|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295237|NCT00906698|P1|Participant Flow|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
295238|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
295239|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
295240|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
295241|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
295242|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
295243|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
295244|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
295245|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
295246|NCT00906698|O2|Outcome|in Absence of Afatinib|60 mg/m^2 vinorelbine per os in absence of Afatinib
295247|NCT00906698|O1|Outcome|in Presence of Afatinib|60 mg/m^2 vinorelbine per os in presence of Afatinib
295248|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
295249|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
295250|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
295251|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
295252|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
295253|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
295254|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
295255|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
295256|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
295257|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
295258|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
295259|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
295260|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
295261|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
295262|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295263|NCT00906698|O1|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295264|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295265|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295266|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295267|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295268|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295269|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
298205|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
295270|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295271|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295272|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295273|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295274|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295275|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295276|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295277|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295278|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295279|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295280|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295281|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295282|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295283|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295284|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295285|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295286|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295287|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295288|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295289|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295290|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
298206|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
295291|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295292|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295293|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295294|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295295|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295296|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295297|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295298|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295299|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295300|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295301|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295302|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295303|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295304|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295305|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295306|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295307|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295308|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295309|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295310|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295311|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
295492|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295312|NCT00906698|E6|Reported Event|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295313|NCT00906698|E5|Reported Event|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295314|NCT00906698|E4|Reported Event|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295315|NCT00906698|E3|Reported Event|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295316|NCT00906698|E2|Reported Event|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295317|NCT00906698|E1|Reported Event|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
295318|NCT00906503|B1|Baseline|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
295319|NCT00906503|P1|Participant Flow|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
295320|NCT00906503|O1|Outcome|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
295321|NCT00906503|E1|Reported Event|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
295322|NCT00906425|B3|Baseline|Total|Total of all reporting groups
295323|NCT00906425|B2|Baseline|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295324|NCT00906425|B1|Baseline|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295325|NCT00906425|P2|Participant Flow|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295326|NCT00906425|P1|Participant Flow|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295327|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295328|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295329|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295330|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295331|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295332|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295333|NCT00906425|E2|Reported Event|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
295334|NCT00906425|E1|Reported Event|Submerged Healing|The dental implants will be placed using a submerged healing treatment
295335|NCT00906399|B4|Baseline|Total|Total of all reporting groups
295336|NCT00906399|B3|Baseline|Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
295337|NCT00906399|B2|Baseline|Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295338|NCT00906399|B1|Baseline|Placebo|Placebo every 2 weeks for 48 weeks
295339|NCT00906399|P7|Participant Flow|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295340|NCT00906399|P6|Participant Flow|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295342|NCT00906399|P4|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295343|NCT00906399|P3|Participant Flow|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295344|NCT00906399|P2|Participant Flow|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295345|NCT00906399|P1|Participant Flow|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295346|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295347|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295348|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295349|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295350|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295351|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295352|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295353|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295354|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295355|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295356|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295357|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295358|NCT00906399|E7|Reported Event|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295359|NCT00906399|E6|Reported Event|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295360|NCT00906399|E5|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
295361|NCT00906399|E4|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295362|NCT00906399|E3|Reported Event|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
295363|NCT00906399|E2|Reported Event|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
295364|NCT00906399|E1|Reported Event|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
295365|NCT00906347|B3|Baseline|Total|Total of all reporting groups
295366|NCT00906347|B2|Baseline|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295367|NCT00906347|B1|Baseline|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295368|NCT00906347|P2|Participant Flow|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295369|NCT00906347|P1|Participant Flow|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295370|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295371|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295372|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295373|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295374|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295375|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295377|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295378|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295379|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295380|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295381|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295382|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295383|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295384|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295385|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295386|NCT00906347|E2|Reported Event|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
295387|NCT00906347|E1|Reported Event|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
295388|NCT00906243|B1|Baseline|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
295389|NCT00906243|P1|Participant Flow|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
295390|NCT00906243|O1|Outcome|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
295391|NCT00906243|E1|Reported Event|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
295392|NCT00906204|B3|Baseline|Total|Total of all reporting groups
295393|NCT00906204|B2|Baseline|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295394|NCT00906204|B1|Baseline|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295395|NCT00906204|P2|Participant Flow|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295396|NCT00906204|P1|Participant Flow|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295397|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295398|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295399|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295400|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295401|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295402|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
298207|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
295403|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295404|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295405|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295406|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295407|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295408|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295409|NCT00906204|E2|Reported Event|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
295410|NCT00906204|E1|Reported Event|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
295411|NCT00906178|B3|Baseline|Total|Total of all reporting groups
295412|NCT00906178|B2|Baseline|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295413|NCT00906178|B1|Baseline|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295414|NCT00906178|P2|Participant Flow|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295415|NCT00906178|P1|Participant Flow|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295416|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295417|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295418|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295419|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295420|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295421|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295422|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295423|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295424|NCT00906178|E2|Reported Event|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
295425|NCT00906178|E1|Reported Event|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
295426|NCT00906074|B3|Baseline|Total|Total of all reporting groups
295427|NCT00906074|B2|Baseline|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295428|NCT00906074|B1|Baseline|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295429|NCT00906074|P2|Participant Flow|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295430|NCT00906074|P1|Participant Flow|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295431|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295432|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295493|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295494|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295433|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295434|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295435|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295436|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295437|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295438|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295439|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295440|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295441|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295442|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295443|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295444|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295445|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295446|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295447|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295448|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295449|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295450|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295451|NCT00906074|E2|Reported Event|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
295452|NCT00906074|E1|Reported Event|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
295453|NCT00905840|B1|Baseline|Two Bone Level Implants in Interforaminal Region|"All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.~The implants were placed in the interforaminal region of the mandible, one implant in each side.~Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis."
295454|NCT00905840|P1|Participant Flow|Titan Grade IV Implant and Titan Zircon Implant|Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
295455|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295456|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295495|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295496|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295457|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295458|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295459|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295460|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
295461|NCT00905840|E1|Reported Event|Two Bone Level Implants in Interforaminal Region|Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
295462|NCT00905827|B4|Baseline|Total|Total of all reporting groups
295463|NCT00905827|B3|Baseline|Control|Control: no training
295464|NCT00905827|B2|Baseline|Intervention: E-training CAMS|Intervention: e-training CAMS training for providers
295465|NCT00905827|B1|Baseline|Intervention 1: In-person CAMS|Intervention: in-person CAMS training for providers
295466|NCT00905827|P3|Participant Flow|Control|Control: no training
295467|NCT00905827|P2|Participant Flow|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
295468|NCT00905827|P1|Participant Flow|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
295469|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
295470|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
295471|NCT00905827|O3|Outcome|Control|Control: no training
295472|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
295473|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
295474|NCT00905827|E3|Reported Event|Arm 3|Control Group: no training
295475|NCT00905827|E2|Reported Event|Arm 2|"Intervention: e-learning CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
295476|NCT00905827|E1|Reported Event|Arm 1|"Intervention: in person CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
295477|NCT00905632|B8|Baseline|Total|Total of all reporting groups
295478|NCT00905632|B7|Baseline|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295479|NCT00905632|B6|Baseline|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295480|NCT00905632|B5|Baseline|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295481|NCT00905632|B4|Baseline|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295482|NCT00905632|B3|Baseline|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295483|NCT00905632|B2|Baseline|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295484|NCT00905632|B1|Baseline|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295485|NCT00905632|P7|Participant Flow|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295486|NCT00905632|P6|Participant Flow|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295487|NCT00905632|P5|Participant Flow|Treatment Experienced (TE): BI 207127 400 mg|Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295488|NCT00905632|P4|Participant Flow|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295489|NCT00905632|P3|Participant Flow|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295490|NCT00905632|P2|Participant Flow|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
295491|NCT00905632|P1|Participant Flow|Treatment Naive (TN): Placebo|Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
305376|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
295497|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295498|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295499|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295500|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295501|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295502|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295503|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295504|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295505|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295506|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295507|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295508|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295509|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295510|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295511|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295512|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295513|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295514|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295515|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295516|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295517|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295518|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295519|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295520|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295521|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295522|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295523|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295524|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295525|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295526|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295527|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295528|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295529|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295530|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295531|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295532|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295533|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295534|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295535|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295536|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295537|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295538|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295539|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295540|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295541|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295542|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295543|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295544|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295545|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295546|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295547|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295548|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295549|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295550|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295551|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295552|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295553|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295554|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295555|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295556|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295557|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295558|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295559|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295560|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295561|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295562|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295563|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295564|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295565|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295566|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295567|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295568|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295569|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295570|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295571|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295572|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295573|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295574|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295575|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295576|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295577|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295578|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295579|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295580|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295581|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295582|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295583|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
298208|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
295584|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295585|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295586|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295587|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295588|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295589|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295590|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295591|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295592|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295593|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295594|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295595|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295596|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295597|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295598|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295599|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295600|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295601|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295602|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295603|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295604|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295605|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295606|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295607|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295608|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295609|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295610|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295611|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295612|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295613|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295614|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295615|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295616|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295617|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295618|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295619|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295620|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295621|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295622|NCT00905632|E4|Reported Event|BI 207127 800 mg|patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295623|NCT00905632|E3|Reported Event|BI 207127 600 mg|patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295624|NCT00905632|E2|Reported Event|BI 207127 400 mg|patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
295625|NCT00905632|E1|Reported Event|Placebo|patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
295626|NCT00905606|B3|Baseline|Total|Total of all reporting groups
295627|NCT00905606|B2|Baseline|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period
295628|NCT00905606|B1|Baseline|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period
295629|NCT00905606|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
295630|NCT00905606|P1|Participant Flow|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.
295631|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
295632|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
295633|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
295634|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
295635|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
295636|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
295637|NCT00905580|B3|Baseline|Total|Total of all reporting groups
295638|NCT00905580|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295639|NCT00905580|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295640|NCT00905580|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295641|NCT00905580|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295642|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295643|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295644|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295645|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295646|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295647|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295648|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295649|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295650|NCT00905580|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
295651|NCT00905580|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
295652|NCT00905567|B3|Baseline|Total|Total of all reporting groups
295653|NCT00905567|B2|Baseline|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
295654|NCT00905567|B1|Baseline|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
295655|NCT00905567|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
295656|NCT00905567|P1|Participant Flow|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
295657|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
295658|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
295659|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
295660|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
295661|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
295662|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
295663|NCT00905554|B3|Baseline|Total|Total of all reporting groups
295664|NCT00905554|B2|Baseline|Air Insufflation|air insufflation during the insertion phase of colonoscopy
295665|NCT00905554|B1|Baseline|Warm Water|warm water irrigation during the insertion phase of colonoscopy
295666|NCT00905554|P2|Participant Flow|Air Insufflation|air insufflation during the insertion phase of colonoscopy
295667|NCT00905554|P1|Participant Flow|Warm Water|warm water irrigation during the insertion phase of colonoscopy
295668|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
295669|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
295670|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
295671|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
295672|NCT00905554|E2|Reported Event|Air Insufflation|air insufflation during the insertion phase of colonoscopy
295673|NCT00905554|E1|Reported Event|Warm Water|warm water irrigation during the insertion phase of colonoscopy
295674|NCT00905515|B4|Baseline|Total|Total of all reporting groups
295675|NCT00905515|B3|Baseline|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
295676|NCT00905515|B2|Baseline|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
295677|NCT00905515|B1|Baseline|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
295678|NCT00905515|P3|Participant Flow|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
295679|NCT00905515|P2|Participant Flow|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL."
295680|NCT00905515|P1|Participant Flow|Remaining on CsA|Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
295681|NCT00905515|O3|Outcome|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
295682|NCT00905515|O2|Outcome|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced TAC with target trough levels 3.0-5.9 ng/mL."
295683|NCT00905515|O1|Outcome|Remaining on CsA|Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
295684|NCT00905515|E3|Reported Event|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
295685|NCT00905515|E2|Reported Event|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
295686|NCT00905515|E1|Reported Event|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
295687|NCT00905489|B1|Baseline|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
295688|NCT00905489|P1|Participant Flow|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
295689|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
295690|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295691|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295692|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295693|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
295694|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295695|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295696|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295697|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
295698|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295699|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295700|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295701|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295702|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295703|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295704|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295705|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295706|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295707|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
295708|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295709|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295710|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295711|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
295712|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
295713|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
295714|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
295715|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295716|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295717|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295718|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295719|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295720|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295721|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295722|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295723|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295724|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295725|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295726|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295727|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295728|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295729|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295730|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295731|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
295732|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
295733|NCT00905489|E1|Reported Event|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
295734|NCT00905437|B3|Baseline|Total|Total of all reporting groups
295735|NCT00905437|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295736|NCT00905437|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295737|NCT00905437|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295738|NCT00905437|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295739|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295740|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295741|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295742|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295743|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295744|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295745|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295746|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295747|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295748|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295749|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295750|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295751|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295752|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295753|NCT00905437|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
295754|NCT00905437|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
295755|NCT00905424|B3|Baseline|Total|Total of all reporting groups
295756|NCT00905424|B2|Baseline|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
295757|NCT00905424|B1|Baseline|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
295758|NCT00905424|P2|Participant Flow|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
295759|NCT00905424|P1|Participant Flow|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
295760|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295761|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295762|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295763|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295764|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295765|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295938|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295766|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295767|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295768|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295769|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295770|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295771|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295772|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295773|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295774|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295775|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295776|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295777|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295778|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295779|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295978|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
295780|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295781|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295782|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295783|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295784|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295785|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295786|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295787|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295788|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295789|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295790|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295791|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295792|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295793|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295979|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
295794|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
295795|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
295796|NCT00905424|E2|Reported Event|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
295797|NCT00905424|E1|Reported Event|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
295798|NCT00905359|B3|Baseline|Total|Total of all reporting groups
295799|NCT00905359|B2|Baseline|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295800|NCT00905359|B1|Baseline|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295801|NCT00905359|P2|Participant Flow|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295802|NCT00905359|P1|Participant Flow|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295803|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295804|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295805|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295806|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295807|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295808|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295809|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295810|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295811|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295812|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295813|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295814|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295815|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295816|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295817|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295818|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295819|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295820|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295821|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295822|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295823|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295824|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295825|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295826|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295827|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295828|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295829|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295830|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295831|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295832|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295833|NCT00905359|E2|Reported Event|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
295834|NCT00905359|E1|Reported Event|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
295835|NCT00905346|B3|Baseline|Total|Total of all reporting groups
295836|NCT00905346|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
295837|NCT00905346|B1|Baseline|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
295838|NCT00905346|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
295839|NCT00905346|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules 2 x 25 mg (reference) dosed in second period
295840|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
295841|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
295842|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
295843|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
295844|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
295845|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
295846|NCT00905307|B7|Baseline|Total|Total of all reporting groups
295847|NCT00905307|B6|Baseline|Placebo|Placebo QD for 6 weeks
295848|NCT00905307|B5|Baseline|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295849|NCT00905307|B4|Baseline|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295850|NCT00905307|B3|Baseline|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295851|NCT00905307|B2|Baseline|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295852|NCT00905307|B1|Baseline|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295853|NCT00905307|P6|Participant Flow|Placebo|Placebo QD for 6 weeks
295854|NCT00905307|P5|Participant Flow|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295855|NCT00905307|P4|Participant Flow|OPC-34712 High Dose|5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295856|NCT00905307|P3|Participant Flow|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295857|NCT00905307|P2|Participant Flow|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295858|NCT00905307|P1|Participant Flow|OPC-34712 0.25 mg|0.25 mg once daily (QD) for 6 weeks
295859|NCT00905307|O6|Outcome|Placebo|Placebo QD
295860|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295861|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
295862|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295863|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physicna could request a dose increase, if needed for efficacy, based on clinical judgment.
295864|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295865|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
295866|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295867|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295868|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
298209|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
295869|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295870|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295871|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
295872|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295873|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295874|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295875|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295876|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295877|NCT00905307|O6|Outcome|Placebo|Placebo QD
295878|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295879|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295880|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295881|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295882|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
295883|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
295884|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295885|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295886|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295887|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295888|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295889|NCT00905307|O6|Outcome|Placebo|Placebo QD
295890|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295891|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295892|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295893|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
295894|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
295895|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
295896|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg.After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295897|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295898|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295899|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295900|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295901|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
295902|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
295903|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
295904|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment , the physician could request a dose increase, if needed for efficacy, based on clinical judgment
298210|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
295905|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
295906|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295907|NCT00905307|E6|Reported Event|Placebo|Placebo QD
295908|NCT00905307|E5|Reported Event|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
295909|NCT00905307|E4|Reported Event|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295910|NCT00905307|E3|Reported Event|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295911|NCT00905307|E2|Reported Event|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
295912|NCT00905307|E1|Reported Event|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
295913|NCT00905268|B5|Baseline|Total|Total of all reporting groups
295914|NCT00905268|B4|Baseline|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295915|NCT00905268|B3|Baseline|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295916|NCT00905268|B2|Baseline|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295917|NCT00905268|B1|Baseline|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295918|NCT00905268|P4|Participant Flow|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295919|NCT00905268|P3|Participant Flow|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295920|NCT00905268|P2|Participant Flow|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295921|NCT00905268|P1|Participant Flow|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295922|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295923|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295924|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295925|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295926|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295927|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295928|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295929|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295930|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295931|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295932|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295933|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295934|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295935|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295936|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295937|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295939|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295940|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295941|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295942|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295943|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295944|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295945|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295946|NCT00905268|E4|Reported Event|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295947|NCT00905268|E3|Reported Event|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295948|NCT00905268|E2|Reported Event|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295949|NCT00905268|E1|Reported Event|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
295950|NCT00905255|B3|Baseline|Total|Total of all reporting groups
295951|NCT00905255|B2|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
295952|NCT00905255|B1|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
295953|NCT00905255|P2|Participant Flow|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
295954|NCT00905255|P1|Participant Flow|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
295955|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295956|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295957|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295958|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
295959|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
295960|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295961|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295962|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295963|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
295964|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
295965|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295966|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
295967|NCT00905255|E2|Reported Event|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
295968|NCT00905255|E1|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
295969|NCT00905164|B3|Baseline|Total|Total of all reporting groups
295970|NCT00905164|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules,2 x 25 mg (test) dosed in second period
295971|NCT00905164|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
295972|NCT00905164|P2|Participant Flow|Topomax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
295973|NCT00905164|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period
295974|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
295975|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
295976|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
295977|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
298211|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
295980|NCT00905151|B1|Baseline|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
295981|NCT00905151|P1|Participant Flow|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
295982|NCT00905151|O1|Outcome|HIV Positive|Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
295983|NCT00905151|E1|Reported Event|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
295984|NCT00905125|B3|Baseline|Total|Total of all reporting groups
295985|NCT00905125|B2|Baseline|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295986|NCT00905125|B1|Baseline|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295987|NCT00905125|P2|Participant Flow|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295988|NCT00905125|P1|Participant Flow|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295989|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295990|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295991|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295992|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295993|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295994|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295995|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295996|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295997|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
295998|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
295999|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296000|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296001|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296002|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296003|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296004|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296005|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296006|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296007|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296008|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296009|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296010|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296011|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296012|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296013|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296014|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296015|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296016|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296017|NCT00905125|E2|Reported Event|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
296018|NCT00905125|E1|Reported Event|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
296019|NCT00905034|B1|Baseline|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
296020|NCT00905034|P1|Participant Flow|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
296021|NCT00905034|O1|Outcome|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
296022|NCT00905034|E1|Reported Event|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
296023|NCT00905021|B1|Baseline|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
296024|NCT00905021|P1|Participant Flow|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
296025|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|This is a single arm study. All patients received Exemestane 25mg per day and Sunitinib 37.5 mg per day.
296026|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
296027|NCT00905021|E1|Reported Event|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
296028|NCT00904995|B3|Baseline|Total|Total of all reporting groups
298212|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
296029|NCT00904995|B2|Baseline|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
296030|NCT00904995|B1|Baseline|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
296031|NCT00904995|P2|Participant Flow|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
296032|NCT00904995|P1|Participant Flow|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
296033|NCT00904995|O2|Outcome|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
296034|NCT00904995|O1|Outcome|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
296035|NCT00904995|E2|Reported Event|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
296036|NCT00904995|E1|Reported Event|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
296037|NCT00904943|B3|Baseline|Total|Total of all reporting groups
296038|NCT00904943|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
296039|NCT00904943|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
296040|NCT00904943|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
296041|NCT00904943|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
296042|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
296043|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
296044|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
296045|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
296046|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
296047|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
296048|NCT00904917|B5|Baseline|Total|Total of all reporting groups
296049|NCT00904917|B4|Baseline|Lecture (Children)|Children of the mother-child dyad in the lecture control group.
296050|NCT00904917|B3|Baseline|Lecture (Mothers)|Mothers of the mother-child dyad in the lecture control group.
296051|NCT00904917|B2|Baseline|Adapted PIP (Children)|Children of the mother-child dyad in the adapted PIP intervention.
296052|NCT00904917|B1|Baseline|Adapted PIP (Mothers)|Mothers of the mother-child dyad in the adapted PIP intervention.
296053|NCT00904917|P4|Participant Flow|Lecture (Children)|"Children of mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
296054|NCT00904917|P3|Participant Flow|Lecture (Mothers)|"Mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
296055|NCT00904917|P2|Participant Flow|Adapted PIP (Children)|"Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.~Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies"
296056|NCT00904917|P1|Participant Flow|Adapted PIP (Mothers)|"Mothers participated in an adapted PIP for the families of children with a depressed African American mother.~Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies."
296057|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
296058|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
296059|NCT00904917|O2|Outcome|Adapted PIP (Child)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
296060|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
296061|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
296062|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression.
296063|NCT00904917|O2|Outcome|Adapted PIP (Child)|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
296064|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
296065|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
296066|NCT00904917|O1|Outcome|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
296067|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
296221|NCT00904150|B1|Baseline|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296068|NCT00904917|O1|Outcome|Adapted PIP|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
296069|NCT00904917|E2|Reported Event|Lecture|Mothers received psychoeducation about depression.
296070|NCT00904917|E1|Reported Event|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project.
296071|NCT00904839|B3|Baseline|Total|Total of all reporting groups
296072|NCT00904839|B2|Baseline|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296073|NCT00904839|B1|Baseline|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296074|NCT00904839|P3|Participant Flow|Bevacizumab 5 mg + mFolfox6 (Phase II)|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296075|NCT00904839|P2|Participant Flow|Nintedanib 200 mg + mFolfox6|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296076|NCT00904839|P1|Participant Flow|Nintedanib 150 mg + mFolfox6|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296077|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296078|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296079|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296080|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296081|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296082|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296083|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296084|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296085|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296086|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296087|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296088|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296089|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296090|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296091|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296092|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296093|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296094|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296095|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296096|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296097|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296098|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296099|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296100|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296101|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296102|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296103|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296104|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296105|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296106|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296107|NCT00904839|E2|Reported Event|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
296108|NCT00904839|E1|Reported Event|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
296109|NCT00904826|B1|Baseline|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296110|NCT00904826|P1|Participant Flow|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296111|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296112|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296113|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296114|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296115|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296222|NCT00904150|P2|Participant Flow|2 No Migraine|Caucasian women with no personal history of migraine
298213|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
296116|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296117|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296118|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296119|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296120|NCT00904826|E1|Reported Event|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
296121|NCT00904748|B1|Baseline|Entire Study Population|Includes all participants who were randomized to any treatment sequence
296122|NCT00904748|P6|Participant Flow|Sequence 6|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
296123|NCT00904748|P5|Participant Flow|Sequence 5|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
296124|NCT00904748|P4|Participant Flow|Sequence 4|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
296125|NCT00904748|P3|Participant Flow|Sequence 3|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
296126|NCT00904748|P2|Participant Flow|Sequence 2|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
296127|NCT00904748|P1|Participant Flow|Sequence 1|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
296128|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296129|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296130|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296131|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296132|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296133|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296134|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296135|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296136|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296137|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296138|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296139|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296140|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296141|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296142|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296143|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296144|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296145|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296146|NCT00904748|E4|Reported Event|Formulation Unspecified|Sildenafil 100 mg tablet: formulation unspecified
296147|NCT00904748|E3|Reported Event|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
296148|NCT00904748|E2|Reported Event|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
296149|NCT00904748|E1|Reported Event|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
296254|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
296255|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
296150|NCT00904722|B1|Baseline|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
296151|NCT00904722|P1|Participant Flow|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
296152|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
296153|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
296154|NCT00904722|E1|Reported Event|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
296155|NCT00904670|B1|Baseline|Entire Study Population|Includes all randomized participants who received at least 1 dose of study medication.
296156|NCT00904670|P2|Participant Flow|OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
296157|NCT00904670|P1|Participant Flow|OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)|Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
296158|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296159|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296160|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296161|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296162|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention period.
296163|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296164|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296165|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296166|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296167|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296168|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296169|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296170|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296171|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296172|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
296173|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
296256|NCT00903929|O1|Outcome|All Participants|
296257|NCT00903929|E1|Reported Event|Eltrombopag|Eltrombopag: dose escalation
296174|NCT00904670|E3|Reported Event|DB Phase (NWP06)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
296175|NCT00904670|E2|Reported Event|DB Phase (Placebo)|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
296176|NCT00904670|E1|Reported Event|OL Phase (NWP06)|NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
296177|NCT00904618|B1|Baseline|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
296178|NCT00904618|P1|Participant Flow|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
296179|NCT00904618|O2|Outcome|U-Method|The ‘U-Method’ is similar to the retropubic tape dissection.
296180|NCT00904618|O1|Outcome|'Hammock' Technique|The ‘Hammock’ technique is similar to the transobturator tape dissection.
296181|NCT00904618|O2|Outcome|U-Method|The U-Method is similar to the retropubic tape dissection
296182|NCT00904618|O1|Outcome|'Hammock' Technique|The 'Hammock' technique is similar to the transobturator tape dissection.
296183|NCT00904618|O1|Outcome|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
296184|NCT00904618|E1|Reported Event|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
296185|NCT00904423|B1|Baseline|Vitamin D|
296186|NCT00904423|P1|Participant Flow|Vitamin D|
296187|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296188|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296189|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296190|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296191|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296192|NCT00904423|E1|Reported Event|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
296193|NCT00904371|B1|Baseline|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
296194|NCT00904371|P1|Participant Flow|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
296195|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296196|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296197|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296198|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296199|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296200|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296201|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296202|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296203|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296204|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296205|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296206|NCT00904371|E1|Reported Event|Micardis® 80mg MicardisPlus® 80/12.5 mg|
296207|NCT00904215|B1|Baseline|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296208|NCT00904215|P1|Participant Flow|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296209|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296210|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296211|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296212|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296213|NCT00904215|E1|Reported Event|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
296214|NCT00904189|B1|Baseline|1Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
296215|NCT00904189|P1|Participant Flow|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
296216|NCT00904189|O1|Outcome|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
296217|NCT00904189|O1|Outcome|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
296218|NCT00904189|E1|Reported Event|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
296219|NCT00904150|B3|Baseline|Total|Total of all reporting groups
296220|NCT00904150|B2|Baseline|2 No Migraine|Caucasian women with no personal history of migraine
296223|NCT00904150|P1|Participant Flow|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296224|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296225|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296226|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296227|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296228|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296229|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296230|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296231|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296232|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296233|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296234|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296235|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296236|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
296237|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296238|NCT00904150|E2|Reported Event|2 No Migraine|Caucasian women with no personal history of migraine
296239|NCT00904150|E1|Reported Event|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
296240|NCT00904007|B3|Baseline|Total|Total of all reporting groups
296241|NCT00904007|B2|Baseline|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
296242|NCT00904007|B1|Baseline|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
296243|NCT00904007|P2|Participant Flow|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
296244|NCT00904007|P1|Participant Flow|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
296245|NCT00904007|O2|Outcome|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
296246|NCT00904007|O1|Outcome|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
296247|NCT00904007|E2|Reported Event|Arm 2|Control clinicians received identical educational content in an online posting with email reminders.
296248|NCT00904007|E1|Reported Event|Arm 1|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
296249|NCT00903929|B1|Baseline|Eltrombopag|Eltrombopag: dose escalation
296250|NCT00903929|P4|Participant Flow|Eltrombopag 300 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
296251|NCT00903929|P3|Participant Flow|Eltrombopag 225 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
296252|NCT00903929|P2|Participant Flow|Eltrombopag 150 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
296253|NCT00903929|P1|Participant Flow|Eltrombopag 75 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
296259|NCT00903695|B2|Baseline|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
296260|NCT00903695|B1|Baseline|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
296261|NCT00903695|P2|Participant Flow|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
296262|NCT00903695|P1|Participant Flow|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
296263|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296264|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296265|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296266|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296267|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296268|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296269|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296270|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296271|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296272|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296273|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296274|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
297338|NCT00899353|O8|Outcome|Fold Change in ALC-Patient 8|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
296275|NCT00903695|O2|Outcome|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
296276|NCT00903695|O1|Outcome|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
296277|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296278|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
296279|NCT00903695|E2|Reported Event|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
296280|NCT00903695|E1|Reported Event|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
296281|NCT00903682|B3|Baseline|Total|Total of all reporting groups
296282|NCT00903682|B2|Baseline|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296283|NCT00903682|B1|Baseline|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
296284|NCT00903682|P2|Participant Flow|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296285|NCT00903682|P1|Participant Flow|Etravirine|Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
296286|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296287|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296288|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296289|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296290|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296291|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296292|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296293|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296294|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296295|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296296|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296297|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296298|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296299|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
296300|NCT00903682|E2|Reported Event|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
296301|NCT00903682|E1|Reported Event|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
296302|NCT00903630|B4|Baseline|Total|Total of all reporting groups
296303|NCT00903630|B3|Baseline|Phase 2|
296304|NCT00903630|B2|Baseline|Phase 1 - Dose Level 2|
296305|NCT00903630|B1|Baseline|Phase 1 - Dose Level 1|
296306|NCT00903630|P3|Participant Flow|Phase 2 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
296307|NCT00903630|P2|Participant Flow|Phase 1 - Dose Level 2|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
296308|NCT00903630|P1|Participant Flow|Phase 1 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
296309|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296310|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296311|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296312|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296313|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296314|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296315|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296316|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296317|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296318|NCT00903630|E3|Reported Event|Phase 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296319|NCT00903630|E2|Reported Event|Phase 1 - Dose Level 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296320|NCT00903630|E1|Reported Event|Phase 1 - Dose Level 1|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
296321|NCT00903448|B1|Baseline|Entire Study Population|
296322|NCT00903448|P2|Participant Flow|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296323|NCT00903448|P1|Participant Flow|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296324|NCT00903448|O2|Outcome|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296325|NCT00903448|O1|Outcome|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296326|NCT00903448|E2|Reported Event|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296327|NCT00903448|E1|Reported Event|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
296328|NCT00903409|B3|Baseline|Total|Total of all reporting groups
296329|NCT00903409|B2|Baseline|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296330|NCT00903409|B1|Baseline|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296331|NCT00903409|P2|Participant Flow|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296332|NCT00903409|P1|Participant Flow|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296333|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
296334|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296335|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296336|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
296337|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296338|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296339|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
296340|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296341|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296342|NCT00903409|E3|Reported Event|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
296343|NCT00903409|E2|Reported Event|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
296344|NCT00903409|E1|Reported Event|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
296345|NCT00903396|B5|Baseline|Total|Total of all reporting groups
296346|NCT00903396|B4|Baseline|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296347|NCT00903396|B3|Baseline|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296348|NCT00903396|B2|Baseline|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296349|NCT00903396|B1|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296350|NCT00903396|P4|Participant Flow|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296351|NCT00903396|P3|Participant Flow|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296352|NCT00903396|P2|Participant Flow|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296353|NCT00903396|P1|Participant Flow|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296354|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296355|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296356|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296357|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296358|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296359|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296360|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296361|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296362|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296363|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296364|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296365|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296366|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296367|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296368|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296369|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296370|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296371|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296372|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296373|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296374|NCT00903396|E4|Reported Event|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
296375|NCT00903396|E3|Reported Event|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
296376|NCT00903396|E2|Reported Event|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
296377|NCT00903396|E1|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
296378|NCT00903383|B5|Baseline|Total|Total of all reporting groups
296379|NCT00903383|B4|Baseline|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296380|NCT00903383|B3|Baseline|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296381|NCT00903383|B2|Baseline|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296382|NCT00903383|B1|Baseline|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296383|NCT00903383|P4|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296384|NCT00903383|P3|Participant Flow|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296385|NCT00903383|P2|Participant Flow|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296386|NCT00903383|P1|Participant Flow|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296387|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296388|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296389|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296390|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296391|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296392|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296393|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296394|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296395|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296396|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296397|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296398|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296399|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296400|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296401|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296402|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296403|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296404|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296405|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296406|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296407|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296408|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296409|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296410|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296411|NCT00903383|E4|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
296412|NCT00903383|E3|Reported Event|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
296413|NCT00903383|E2|Reported Event|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
296414|NCT00903383|E1|Reported Event|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
296415|NCT00903370|B3|Baseline|Total|Total of all reporting groups
296416|NCT00903370|B2|Baseline|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
296417|NCT00903370|B1|Baseline|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
296418|NCT00903370|P2|Participant Flow|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
296419|NCT00903370|P1|Participant Flow|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
296420|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
296421|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
296422|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
296423|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
296424|NCT00903370|E2|Reported Event|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
296425|NCT00903370|E1|Reported Event|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
296426|NCT00903357|B1|Baseline|Entire Study Population|Includes groups randomized to receive Montelukast first and placebo first.
296427|NCT00903357|P2|Participant Flow|Placebo First, Then Montelukast|Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
296428|NCT00903357|P1|Participant Flow|Montelukast First, Then Placebo|Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).
296429|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine EDN after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296430|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine EDN after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296431|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine LTE4 after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296432|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine LTE4 after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296472|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296534|NCT00902850|B1|Baseline|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
296433|NCT00903357|O2|Outcome|Placebo Drug|Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296434|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
296435|NCT00903357|E2|Reported Event|Placebo Drug|Placebo drug administered once daily in either first intervention period or second intervention period.
296436|NCT00903357|E1|Reported Event|Montelukast Sodium|Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period.
296437|NCT00903344|B3|Baseline|Total|Total of all reporting groups
296438|NCT00903344|B2|Baseline|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296439|NCT00903344|B1|Baseline|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296440|NCT00903344|P2|Participant Flow|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296441|NCT00903344|P1|Participant Flow|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296442|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296443|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296444|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296445|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296446|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296447|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296448|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296449|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296450|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296451|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296452|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296453|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296454|NCT00903344|E2|Reported Event|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
296455|NCT00903344|E1|Reported Event|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
296456|NCT00903331|B3|Baseline|Total|Total of all reporting groups
296457|NCT00903331|B2|Baseline|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
296458|NCT00903331|B1|Baseline|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
296459|NCT00903331|P2|Participant Flow|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
296460|NCT00903331|P1|Participant Flow|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
296461|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
296462|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
296463|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
296464|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
296465|NCT00903331|E2|Reported Event|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
296466|NCT00903331|E1|Reported Event|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
296467|NCT00903175|B3|Baseline|Total|Total of all reporting groups
296468|NCT00903175|B2|Baseline|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296469|NCT00903175|B1|Baseline|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296470|NCT00903175|P2|Participant Flow|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296471|NCT00903175|P1|Participant Flow|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296716|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
296473|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296474|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296475|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296476|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296477|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296478|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296479|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296480|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296481|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296482|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296483|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296484|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296485|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296486|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296487|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296488|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296489|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296490|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296491|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296492|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296493|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296494|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296495|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296496|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296497|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296498|NCT00903175|E2|Reported Event|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
296499|NCT00903175|E1|Reported Event|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
296530|NCT00903006|E2|Reported Event|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296717|NCT00902174|O1|Outcome|Imatinib 200 mg|imatinib mesylate 200 mg once daily
296500|NCT00903162|B1|Baseline|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296501|NCT00903162|P1|Participant Flow|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296502|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296503|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296504|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296505|NCT00903162|E1|Reported Event|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
296506|NCT00903032|B3|Baseline|Total|Total of all reporting groups
296507|NCT00903032|B2|Baseline|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
296508|NCT00903032|B1|Baseline|Patient Centered Intervention|The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
296509|NCT00903032|P2|Participant Flow|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
296510|NCT00903032|P1|Participant Flow|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re"
296511|NCT00903032|O2|Outcome|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
296512|NCT00903032|O1|Outcome|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
296513|NCT00903032|E2|Reported Event|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
296531|NCT00903006|E1|Reported Event|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
296514|NCT00903032|E1|Reported Event|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
296515|NCT00903006|B5|Baseline|Total|Total of all reporting groups
296516|NCT00903006|B4|Baseline|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296517|NCT00903006|B3|Baseline|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
296518|NCT00903006|B2|Baseline|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296519|NCT00903006|B1|Baseline|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
296520|NCT00903006|P4|Participant Flow|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296521|NCT00903006|P3|Participant Flow|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
296522|NCT00903006|P2|Participant Flow|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296523|NCT00903006|P1|Participant Flow|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
296524|NCT00903006|O4|Outcome|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296525|NCT00903006|O3|Outcome|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
296526|NCT00903006|O2|Outcome|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296527|NCT00903006|O1|Outcome|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
296528|NCT00903006|E4|Reported Event|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
296529|NCT00903006|E3|Reported Event|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
296532|NCT00902850|B3|Baseline|Total|Total of all reporting groups
296533|NCT00902850|B2|Baseline|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
296535|NCT00902850|P2|Participant Flow|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
296536|NCT00902850|P1|Participant Flow|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
296537|NCT00902850|O2|Outcome|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
296538|NCT00902850|O1|Outcome|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
296539|NCT00902850|E2|Reported Event|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
296540|NCT00902850|E1|Reported Event|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
296541|NCT00902746|B1|Baseline|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
296542|NCT00902746|P1|Participant Flow|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
296543|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
296544|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
296545|NCT00902746|E1|Reported Event|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
296546|NCT00902668|B1|Baseline|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
296547|NCT00902668|P1|Participant Flow|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
296548|NCT00902668|O1|Outcome|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
296549|NCT00902668|E1|Reported Event|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
296550|NCT00902564|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296551|NCT00902564|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296552|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296553|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296554|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296555|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296556|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296557|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296558|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296559|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296560|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296561|NCT00902564|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296562|NCT00902538|B4|Baseline|Total|Total of all reporting groups
296718|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296563|NCT00902538|B3|Baseline|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296564|NCT00902538|B2|Baseline|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
296565|NCT00902538|B1|Baseline|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296566|NCT00902538|P6|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
296567|NCT00902538|P5|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
296568|NCT00902538|P4|Participant Flow|OLM 40-AML 10-HCTZ 12.5 (Responders)|Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
296569|NCT00902538|P3|Participant Flow|OLM 40-AML 10-HCTZ 25|Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
296570|NCT00902538|P2|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296571|NCT00902538|P1|Participant Flow|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
296572|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296573|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296574|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296575|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296576|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296577|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296578|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296579|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296580|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296581|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
296582|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296583|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296584|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296585|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296586|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296587|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296588|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296589|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296590|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296719|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296591|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296592|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296593|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296594|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296595|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296596|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296597|NCT00902538|E3|Reported Event|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
296598|NCT00902538|E2|Reported Event|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
296599|NCT00902538|E1|Reported Event|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
296600|NCT00902330|B3|Baseline|Total|Total of all reporting groups
296601|NCT00902330|B2|Baseline|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
296602|NCT00902330|B1|Baseline|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
296603|NCT00902330|P2|Participant Flow|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
296604|NCT00902330|P1|Participant Flow|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
296605|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296606|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
296607|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
296608|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296609|NCT00902330|O2|Outcome|Arm II|Sham CES
296610|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296611|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296612|NCT00902330|O2|Outcome|Arm II|Sham CES
296613|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296614|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296615|NCT00902330|O2|Outcome|Arm II|Sham CES
296616|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296617|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296618|NCT00902330|O2|Outcome|Arm II|Sham CES
296619|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296620|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296621|NCT00902330|O2|Outcome|Arm II|Sham CES
296622|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296623|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296624|NCT00902330|O2|Outcome|Arm II|Sham CES
296625|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296626|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296627|NCT00902330|O2|Outcome|Arm II|Sham CES
296628|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296629|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296630|NCT00902330|O2|Outcome|Arm II|Sham CES
296631|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
296632|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
296633|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
296720|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296721|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296634|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
296635|NCT00902330|E2|Reported Event|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
296636|NCT00902330|E1|Reported Event|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
296637|NCT00902304|B4|Baseline|Total|Total of all reporting groups
296638|NCT00902304|B3|Baseline|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296639|NCT00902304|B2|Baseline|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296640|NCT00902304|B1|Baseline|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296641|NCT00902304|P3|Participant Flow|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296642|NCT00902304|P2|Participant Flow|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296643|NCT00902304|P1|Participant Flow|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296644|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296645|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296646|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296647|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296648|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296649|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296722|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296723|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296724|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296650|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296651|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296652|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296653|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296654|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296655|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296656|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296657|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296658|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296659|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296660|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296661|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296662|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296663|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296664|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296725|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296726|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296727|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296728|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296665|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296666|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296667|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296668|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296669|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296670|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296671|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296672|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296673|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296674|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296675|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296676|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296677|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296678|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296679|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296729|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296730|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296731|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
296732|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
296680|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296681|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296682|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296683|NCT00902304|E4|Reported Event|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296684|NCT00902304|E3|Reported Event|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
296685|NCT00902304|E2|Reported Event|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
296686|NCT00902304|E1|Reported Event|Pre-randomization|Pre-randomization
296687|NCT00902265|B1|Baseline|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296688|NCT00902265|P1|Participant Flow|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296689|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296690|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296691|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296692|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296693|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296694|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296695|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296696|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296697|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296698|NCT00902265|E1|Reported Event|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
296699|NCT00902226|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296700|NCT00902226|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296701|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296702|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296703|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296704|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296705|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296706|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296707|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296708|NCT00902226|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
296709|NCT00902174|B3|Baseline|Total|Total of all reporting groups
296710|NCT00902174|B2|Baseline|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
296711|NCT00902174|B1|Baseline|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
296712|NCT00902174|P2|Participant Flow|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
296713|NCT00902174|P1|Participant Flow|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
296714|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
296715|NCT00902174|O1|Outcome|Imatinib 400 mg|imatinib mesylate 400 mg once daily
296749|NCT00902161|B2|Baseline|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296750|NCT00902161|B1|Baseline|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296751|NCT00902161|P3|Participant Flow|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).
296752|NCT00902161|P2|Participant Flow|Propanolol + Placebo / Propanolol + MK0893|After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
296753|NCT00902161|P1|Participant Flow|Propanolol + MK0893 / Propanolol + Placebo|After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
296754|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
296755|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296756|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296757|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
296758|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296759|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296760|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296761|NCT00902161|O1|Outcome|MK0893|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296762|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296763|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296764|NCT00902161|E3|Reported Event|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
296765|NCT00902161|E2|Reported Event|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296766|NCT00902161|E1|Reported Event|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
296767|NCT00901901|B3|Baseline|Total|Total of all reporting groups
296768|NCT00901901|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296769|NCT00901901|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296770|NCT00901901|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296771|NCT00901901|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296772|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296773|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296774|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296775|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296776|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296777|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296778|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296779|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296780|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296781|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296782|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296783|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296784|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296785|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296786|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296787|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296788|NCT00901901|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
296789|NCT00901901|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
296790|NCT00901628|B3|Baseline|Total|Total of all reporting groups
296791|NCT00901628|B2|Baseline|No Injection Group|usual postoperative care without periarticular injection
296792|NCT00901628|B1|Baseline|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296793|NCT00901628|P2|Participant Flow|No Injection Group|usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
296794|NCT00901628|P1|Participant Flow|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296795|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296796|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296797|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296798|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296799|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296800|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296801|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296802|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296803|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296804|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296805|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
296806|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296807|NCT00901628|E2|Reported Event|No Injection Group|usual postoperative care without periarticular injection
296808|NCT00901628|E1|Reported Event|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
296809|NCT00901576|B7|Baseline|Total|Total of all reporting groups
296810|NCT00901576|B6|Baseline|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
296811|NCT00901576|B5|Baseline|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
296812|NCT00901576|B4|Baseline|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
296813|NCT00901576|B3|Baseline|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
296814|NCT00901576|B2|Baseline|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
296815|NCT00901576|B1|Baseline|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
296816|NCT00901576|P6|Participant Flow|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
296817|NCT00901576|P5|Participant Flow|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
296881|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
305704|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
296818|NCT00901576|P4|Participant Flow|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
296819|NCT00901576|P3|Participant Flow|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
296820|NCT00901576|P2|Participant Flow|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
296821|NCT00901576|P1|Participant Flow|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
296822|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296823|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
296824|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296825|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
296826|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296827|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
296828|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296829|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
296830|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296831|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
296832|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296833|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
296834|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296835|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
296836|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296837|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
296838|NCT00901576|E3|Reported Event|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
296839|NCT00901576|E2|Reported Event|Concerta Alone|Single 36 mg dose of extended-release methylphenidate HCl
296840|NCT00901576|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release guanfacine HCl
296841|NCT00901459|B1|Baseline|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
296842|NCT00901459|P1|Participant Flow|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
296843|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
296844|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
296845|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
296846|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
296847|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
296848|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
296849|NCT00901459|E3|Reported Event|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
296850|NCT00901459|E2|Reported Event|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
296851|NCT00901459|E1|Reported Event|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
296852|NCT00901316|B3|Baseline|Total|Total of all reporting groups
296853|NCT00901316|B2|Baseline|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
296854|NCT00901316|B1|Baseline|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
296855|NCT00901316|P2|Participant Flow|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
296856|NCT00901316|P1|Participant Flow|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
296857|NCT00901316|O2|Outcome|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
296858|NCT00901316|O1|Outcome|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
296859|NCT00901316|E2|Reported Event|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
296860|NCT00901316|E1|Reported Event|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
296861|NCT00901225|B1|Baseline|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296862|NCT00901225|P1|Participant Flow|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296863|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296864|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296865|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296866|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296867|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296868|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296869|NCT00901225|E1|Reported Event|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
296870|NCT00901186|B3|Baseline|Total|Total of all reporting groups
296871|NCT00901186|B2|Baseline|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296872|NCT00901186|B1|Baseline|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296873|NCT00901186|P2|Participant Flow|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296874|NCT00901186|P1|Participant Flow|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296875|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296876|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296877|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296878|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296879|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296880|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
298214|NCT00894803|E2|Reported Event|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
296882|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296883|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296884|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296885|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296886|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296887|NCT00901186|E2|Reported Event|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
296888|NCT00901186|E1|Reported Event|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
296889|NCT00901017|B1|Baseline|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
296890|NCT00901017|P1|Participant Flow|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
296891|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
296892|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296893|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
296894|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296895|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
296896|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296897|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
296898|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296899|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
296900|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296901|NCT00901017|E2|Reported Event|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
296902|NCT00901017|E1|Reported Event|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
296903|NCT00900822|B1|Baseline|Straumann Bone Ceramic|Synthetic bone graft material
296904|NCT00900822|P1|Participant Flow|Straumann BoneCeramic|Synthetic bone graft material
296905|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
296906|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
296907|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
296908|NCT00900822|O1|Outcome|Straumann BoneCeramic|Synthetic bone graft material
296909|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
296910|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
296911|NCT00900822|E2|Reported Event|BioOss|Xenograft bone graft material
296912|NCT00900822|E1|Reported Event|Straumann Bone Ceramic|Synthetic bone graft material
296913|NCT00900796|B1|Baseline|Anti-tumor Necrosis Factor Agents (Evaluable Population)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
296914|NCT00900796|P1|Participant Flow|Anti-tumor Necrosis Factor Agents|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
296915|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
297339|NCT00899353|O7|Outcome|Fold Change in ALC-Patient 7|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
296916|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
296917|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
296918|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
296919|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
296920|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
296921|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
296922|NCT00900796|E1|Reported Event|Anti-tumor Necrosis Factor Agents|Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
296923|NCT00900757|B1|Baseline|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296924|NCT00900757|P1|Participant Flow|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296925|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296926|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296927|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296928|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296929|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296980|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296930|NCT00900757|E1|Reported Event|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
296931|NCT00900731|B3|Baseline|Total|Total of all reporting groups
296932|NCT00900731|B2|Baseline|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296933|NCT00900731|B1|Baseline|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296934|NCT00900731|P2|Participant Flow|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296935|NCT00900731|P1|Participant Flow|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296936|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296937|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296938|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296939|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296940|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296941|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296942|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296943|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296944|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296945|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296946|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296947|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296948|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296949|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296981|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
297340|NCT00899353|O6|Outcome|Fold Change in ALC-Patient 6|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
296950|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296951|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296952|NCT00900731|E2|Reported Event|Tiotropium 18 μg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296953|NCT00900731|E1|Reported Event|Indacaterol 150 μg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
296954|NCT00900666|B3|Baseline|Total|Total of all reporting groups
296955|NCT00900666|B2|Baseline|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
296956|NCT00900666|B1|Baseline|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
296957|NCT00900666|P2|Participant Flow|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
296958|NCT00900666|P1|Participant Flow|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
296959|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
296960|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
296961|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
296962|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
296963|NCT00900666|E2|Reported Event|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
296964|NCT00900666|E1|Reported Event|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
296965|NCT00900627|B7|Baseline|Total|Total of all reporting groups
296966|NCT00900627|B6|Baseline|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296967|NCT00900627|B5|Baseline|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296968|NCT00900627|B4|Baseline|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296969|NCT00900627|B3|Baseline|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296970|NCT00900627|B2|Baseline|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296971|NCT00900627|B1|Baseline|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296972|NCT00900627|P6|Participant Flow|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296973|NCT00900627|P5|Participant Flow|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296974|NCT00900627|P4|Participant Flow|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296975|NCT00900627|P3|Participant Flow|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296976|NCT00900627|P2|Participant Flow|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296977|NCT00900627|P1|Participant Flow|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296978|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296979|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296982|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296983|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296984|NCT00900627|O4|Outcome|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296985|NCT00900627|O3|Outcome|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296986|NCT00900627|O2|Outcome|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296987|NCT00900627|O1|Outcome|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296988|NCT00900627|E6|Reported Event|Placebo + Paclitaxel|
296989|NCT00900627|E5|Reported Event|AZD8931 40MG bd + Paclitaxel|
296990|NCT00900627|E4|Reported Event|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296991|NCT00900627|E3|Reported Event|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
296992|NCT00900627|E2|Reported Event|AZD8931 80 mg bd|
296993|NCT00900627|E1|Reported Event|AZD8931 40 mg bd|
296994|NCT00900237|B3|Baseline|Total|Total of all reporting groups
296995|NCT00900237|B2|Baseline|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
296996|NCT00900237|B1|Baseline|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
296997|NCT00900237|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
296998|NCT00900237|P1|Participant Flow|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
296999|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
297000|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
297001|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
297002|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
297003|NCT00900237|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
297004|NCT00900237|E1|Reported Event|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
297005|NCT00900146|B6|Baseline|Total|Total of all reporting groups
297006|NCT00900146|B5|Baseline|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297007|NCT00900146|B4|Baseline|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297008|NCT00900146|B3|Baseline|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297009|NCT00900146|B2|Baseline|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297010|NCT00900146|B1|Baseline|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297011|NCT00900146|P5|Participant Flow|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297012|NCT00900146|P4|Participant Flow|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297013|NCT00900146|P3|Participant Flow|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297014|NCT00900146|P2|Participant Flow|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297015|NCT00900146|P1|Participant Flow|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297016|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297017|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297018|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297019|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297153|NCT00899717|B2|Baseline|Sham Occlusal Adjustment|
297154|NCT00899717|B1|Baseline|Real Occlusal Adjustment|
298215|NCT00894803|E1|Reported Event|Rt-PA Only|rt-PA (0.9 mg/kg)
297020|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297021|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297022|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297023|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297024|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297025|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297026|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297027|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297028|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297029|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297155|NCT00899717|P2|Participant Flow|Sham Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
297156|NCT00899717|P1|Participant Flow|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
297030|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297031|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297032|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297033|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297034|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297035|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297036|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297037|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297038|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297039|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297157|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
297158|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
297040|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297041|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297042|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297043|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297044|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297045|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297046|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297047|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297048|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297049|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297159|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
297160|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
297161|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Number of patients who changed their habitual chewing side
297050|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297051|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297052|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297053|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297054|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297055|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297056|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297057|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297058|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297059|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297162|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Number of patients who changed their habitual chewing side
297163|NCT00899717|O2|Outcome|Placebo|
297164|NCT00899717|O1|Outcome|Real|
297165|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
297060|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297061|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297062|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297063|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297064|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297065|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297066|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297067|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297068|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297069|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297166|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
297167|NCT00899717|E2|Reported Event|Sham Occlusal Adjustment|
297168|NCT00899717|E1|Reported Event|Real Occlusal Adjustment|
297169|NCT00899678|B4|Baseline|Total|Total of all reporting groups
297070|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297071|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297072|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297073|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297074|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297075|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297076|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297077|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297078|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297079|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297206|NCT00899600|P1|Participant Flow|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
298216|NCT00894790|B3|Baseline|Total|Total of all reporting groups
297080|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297081|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297082|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297083|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297084|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297085|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297086|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297087|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297088|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297089|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297207|NCT00899600|O2|Outcome|Ketamine|Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
297341|NCT00899353|O5|Outcome|Fold Change in ALC-Patient 5|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297090|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297091|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297092|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297093|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297094|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297095|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297096|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297097|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297098|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297099|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297208|NCT00899600|O1|Outcome|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
297209|NCT00899600|E2|Reported Event|Ketamine|
297100|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297101|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297102|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297103|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297104|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297105|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297106|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297107|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297108|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297109|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297210|NCT00899600|E1|Reported Event|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
305705|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
297110|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297111|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297112|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297113|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297114|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297115|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297116|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297117|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297118|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297119|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297261|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
305706|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
297120|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297121|NCT00900146|E5|Reported Event|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
297122|NCT00900146|E4|Reported Event|Canakinumab 150 mg + Metformin|"Experimental: Canakinumab 150 mg + Metformin In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297123|NCT00900146|E3|Reported Event|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297124|NCT00900146|E2|Reported Event|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297125|NCT00900146|E1|Reported Event|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
297126|NCT00900029|B6|Baseline|Total|Total of all reporting groups
297127|NCT00900029|B5|Baseline|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
297128|NCT00900029|B4|Baseline|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
297129|NCT00900029|B3|Baseline|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
297130|NCT00900029|B2|Baseline|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
297131|NCT00900029|B1|Baseline|HP802-247 Vehicle|
297132|NCT00900029|P5|Participant Flow|HP802-247 Vehicle|
297133|NCT00900029|P4|Participant Flow|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
297134|NCT00900029|P3|Participant Flow|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
297135|NCT00900029|P2|Participant Flow|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
297136|NCT00900029|P1|Participant Flow|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
297137|NCT00900029|O5|Outcome|HP802-247 Vehicle|
297138|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
297139|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
297140|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
297141|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
297142|NCT00900029|O5|Outcome|HP802-247 Vehicle|
297143|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
297144|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
297145|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
297146|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
297147|NCT00900029|E5|Reported Event|HP802-247 Vehicle|
297148|NCT00900029|E4|Reported Event|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
297149|NCT00900029|E3|Reported Event|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
297150|NCT00900029|E2|Reported Event|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
297151|NCT00900029|E1|Reported Event|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
297152|NCT00899717|B3|Baseline|Total|Total of all reporting groups
297170|NCT00899678|B3|Baseline|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297171|NCT00899678|B2|Baseline|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297172|NCT00899678|B1|Baseline|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
297173|NCT00899678|P3|Participant Flow|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297174|NCT00899678|P2|Participant Flow|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297175|NCT00899678|P1|Participant Flow|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
297176|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297177|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297178|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297179|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297180|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297181|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297182|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297183|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297184|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297185|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297342|NCT00899353|O4|Outcome|Fold Change in ALC-Patient 4|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297186|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297187|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297188|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297189|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297190|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297191|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297192|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297193|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297194|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297195|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297196|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297197|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297198|NCT00899678|E4|Reported Event|Overall Study|Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
297199|NCT00899678|E3|Reported Event|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297200|NCT00899678|E2|Reported Event|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
297201|NCT00899678|E1|Reported Event|Induction Period|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
297202|NCT00899600|B3|Baseline|Total|Total of all reporting groups
297203|NCT00899600|B2|Baseline|Ketamine|
297204|NCT00899600|B1|Baseline|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
297205|NCT00899600|P2|Participant Flow|Ketamine|
305707|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
297211|NCT00899574|B1|Baseline|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
297212|NCT00899574|P1|Participant Flow|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
297213|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
297214|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
297215|NCT00899574|E1|Reported Event|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
297216|NCT00899470|B1|Baseline|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
297217|NCT00899470|P4|Participant Flow|S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)|Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
297218|NCT00899470|P3|Participant Flow|S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)|Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
297219|NCT00899470|P2|Participant Flow|S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)|Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
297220|NCT00899470|P1|Participant Flow|S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)|Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
297221|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297222|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297223|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297224|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297225|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297226|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297227|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297228|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297229|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297230|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297231|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297232|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297262|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297263|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297343|NCT00899353|O3|Outcome|Fold Change in ALC-Patient 3|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297233|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
297234|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297235|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
297236|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297237|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297238|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
297239|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297240|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
297241|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297242|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297243|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297244|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297245|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297246|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297247|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297248|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297249|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297250|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297251|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297252|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297253|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297254|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297255|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297256|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297257|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297258|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297259|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297260|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297264|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297265|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297266|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297267|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297268|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297269|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297270|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297271|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297272|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297273|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297274|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297275|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297276|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297277|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297278|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297279|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297280|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297281|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297282|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297283|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297284|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297285|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297286|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297287|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297288|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297289|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297290|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297291|NCT00899470|E4|Reported Event|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
297292|NCT00899470|E3|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
297293|NCT00899470|E2|Reported Event|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
297294|NCT00899470|E1|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
297295|NCT00899392|B3|Baseline|Total|Total of all reporting groups
297296|NCT00899392|B2|Baseline|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297337|NCT00899353|O9|Outcome|Fold Change in ALC-Patient 9|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297297|NCT00899392|B1|Baseline|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297298|NCT00899392|P2|Participant Flow|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297299|NCT00899392|P1|Participant Flow|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297300|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297301|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297302|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297303|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297304|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297305|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297306|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297307|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297308|NCT00899392|E2|Reported Event|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
297309|NCT00899392|E1|Reported Event|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
297310|NCT00899379|B6|Baseline|Total|Total of all reporting groups
297311|NCT00899379|B5|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297312|NCT00899379|B4|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297313|NCT00899379|B3|Baseline|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297314|NCT00899379|B2|Baseline|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297315|NCT00899379|B1|Baseline|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297316|NCT00899379|P5|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297317|NCT00899379|P4|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297318|NCT00899379|P3|Participant Flow|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297319|NCT00899379|P2|Participant Flow|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297320|NCT00899379|P1|Participant Flow|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
297321|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
297322|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
297323|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
297324|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
297325|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
297326|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
297327|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
297328|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
297329|NCT00899379|E2|Reported Event|Placebo|All Placebo patients from all Treatment Sequences
297330|NCT00899379|E1|Reported Event|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
297331|NCT00899353|B1|Baseline|Omega 3 Supplementation|
297332|NCT00899353|P1|Participant Flow|Omega 3 Supplementation|Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
297333|NCT00899353|O13|Outcome|Fold Change in ALC-Patient 14|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297334|NCT00899353|O12|Outcome|Fold Change in ALC-Patient 13|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297335|NCT00899353|O11|Outcome|Fold Change in ALC-Patient 11|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297336|NCT00899353|O10|Outcome|Fold Change in ALC-Patient 10|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297344|NCT00899353|O2|Outcome|Fold Change in ALC-Patient 2|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297345|NCT00899353|O1|Outcome|Fold Change in ALC-Patient 1|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
297346|NCT00899353|O5|Outcome|Nuclear Factor Kappa B Activation Post Supplement|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
297347|NCT00899353|O4|Outcome|Nuclear Factor Kappa B Activation Following 9 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
297348|NCT00899353|O3|Outcome|Nuclear Factor Kappa B Activation Following 6 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
297349|NCT00899353|O2|Outcome|Nuclear Factor Kappa B Activation Following 3 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
297350|NCT00899353|O1|Outcome|Baseline Nuclear Factor Kappa B Activation|Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
297351|NCT00899353|E1|Reported Event|Adverse Effects|Serious adverse effects associated with omega 3 fatty acid consumption.
297352|NCT00898807|B3|Baseline|Total|Total of all reporting groups
297353|NCT00898807|B2|Baseline|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297354|NCT00898807|B1|Baseline|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297355|NCT00898807|P2|Participant Flow|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297356|NCT00898807|P1|Participant Flow|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297357|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297358|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297359|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297360|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297361|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297362|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297363|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297364|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297365|NCT00898807|E2|Reported Event|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
297366|NCT00898807|E1|Reported Event|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
297367|NCT00898677|B5|Baseline|Total|Total of all reporting groups
297368|NCT00898677|B4|Baseline|Placebo|"Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
297369|NCT00898677|B3|Baseline|Sumatriptan 100 mg|"Sumatriptan 100 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
297370|NCT00898677|B2|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
297371|NCT00898677|B1|Baseline|Rizatriptan 5 mg|"Rizatriptan 5 mg orally once for treatment of single migraine attack.~Baseline measure Participants reported are those participants that recieved study treatment."
297372|NCT00898677|P4|Participant Flow|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297373|NCT00898677|P3|Participant Flow|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297374|NCT00898677|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297375|NCT00898677|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297376|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297377|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297378|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297379|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297380|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297381|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297382|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297383|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
305708|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
297384|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297385|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297386|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297387|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297388|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297389|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297390|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297391|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297392|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297393|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297394|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297395|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297396|NCT00898677|E4|Reported Event|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
297397|NCT00898677|E3|Reported Event|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
297398|NCT00898677|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297399|NCT00898677|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297400|NCT00898560|B1|Baseline|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297401|NCT00898560|P1|Participant Flow|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297402|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297403|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
297404|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297405|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
297406|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297407|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
297408|NCT00898560|E2|Reported Event|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
297409|NCT00898560|E1|Reported Event|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
297410|NCT00898443|B3|Baseline|Total|Total of all reporting groups
297411|NCT00898443|B2|Baseline|Epidural Anesthetic Group|This is the experimental group for this study.
297412|NCT00898443|B1|Baseline|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
297413|NCT00898443|P2|Participant Flow|Epidural Anesthetic Group|This is the experimental group for this study.
297414|NCT00898443|P1|Participant Flow|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
297415|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
297416|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
297417|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
297418|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
297419|NCT00898443|E2|Reported Event|Epidural Anesthetic Group|This is the experimental group for this study.
297420|NCT00898443|E1|Reported Event|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
297421|NCT00898222|B1|Baseline|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
297422|NCT00898222|P1|Participant Flow|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
297423|NCT00898222|O1|Outcome|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
297424|NCT00898222|E1|Reported Event|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
297425|NCT00897949|B4|Baseline|Total|Total of all reporting groups
297426|NCT00897949|B3|Baseline|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297427|NCT00897949|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297428|NCT00897949|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297429|NCT00897949|P3|Participant Flow|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297430|NCT00897949|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297431|NCT00897949|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297432|NCT00897949|O6|Outcome|Placebo / Rizatriptan 10 mg|Placebo initially, prerandomized to rizatriptan 10 mg
297433|NCT00897949|O5|Outcome|Placebo / Rizatriptan 5 mg|Placebo initially, prerandomized to rizatriptan 5 mg
297434|NCT00897949|O4|Outcome|Rizatriptan 10 mg / Placebo|Rizatriptan 10 mg initially, prerandomized to placebo
297435|NCT00897949|O3|Outcome|Rizatriptan 10 mg / Rizatriptan 10 mg|Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
297436|NCT00897949|O2|Outcome|Rizatriptan 5 mg / Placebo|Rizatriptan 5 mg initially, prerandomized to placebo
297437|NCT00897949|O1|Outcome|Rizatriptan 5 mg / Rizatriptan 5 mg|Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
297438|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297439|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297440|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297441|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297442|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297443|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297444|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297445|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297446|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297447|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297448|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297449|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297450|NCT00897949|E3|Reported Event|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
297451|NCT00897949|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
297452|NCT00897949|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297453|NCT00897910|B1|Baseline|Collection of Circulating Blood and Bone Marrow.|
297454|NCT00897910|P1|Participant Flow|Collection of Circulating Blood and Bone Marrow.|
297455|NCT00897910|O1|Outcome|Collection of Blood and Bone Marrow.|
297456|NCT00897910|E1|Reported Event|Collection of Circulating Blood and Bone Marrow.|
297457|NCT00897897|B1|Baseline|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
297458|NCT00897897|P1|Participant Flow|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
297459|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
297460|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
297461|NCT00897897|E1|Reported Event|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
297462|NCT00897715|B3|Baseline|Total|Total of all reporting groups
305709|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
297463|NCT00897715|B2|Baseline|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
297464|NCT00897715|B1|Baseline|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
297465|NCT00897715|P2|Participant Flow|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
297466|NCT00897715|P1|Participant Flow|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
297467|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
297468|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
297469|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
297470|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
297471|NCT00897715|E2|Reported Event|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
297472|NCT00897715|E1|Reported Event|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
297473|NCT00897390|B1|Baseline|All Enrolled and Treated Participants|
297474|NCT00897390|P1|Participant Flow|All Treated Participants|Participants were assigned to 1 of 4 treatment sequences (A-D-B-C, B-A-C-D, C-B-D-A, D-C-A-B). Treatment A=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fasted; Treatment B=fixed-dose combination (FDC) tablet of 2.5-mg saxagliptin/1000-mg metformin immediate release (IR), fasted; Treatment C=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fed; Treatment D=FDC tablet of 2.5-mg saxagliptin/1000-mg metformin IR, fed. The washout between each dose was at least 7 days.
297475|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297476|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297477|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297478|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297479|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297480|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297481|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297482|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297483|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297484|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297485|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297486|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297487|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297488|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297489|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297490|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297491|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297492|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297493|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297494|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297495|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297496|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
298501|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
297497|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297498|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297499|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297500|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297501|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297502|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297503|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297504|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297505|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297506|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297507|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297508|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297509|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297510|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297511|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297512|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297513|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297514|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297515|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297516|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297517|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297518|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297519|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297520|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297521|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297522|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297523|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297524|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297525|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297526|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297527|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297528|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297563|NCT00897104|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297529|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297530|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297531|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297532|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297533|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297534|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297535|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297536|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297537|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297538|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297539|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297540|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297541|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297542|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297543|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297544|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297545|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297546|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297547|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297548|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297549|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297550|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297551|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
297552|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
297553|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297554|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
297555|NCT00897390|E5|Reported Event|Not Dosed|58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
297556|NCT00897390|E4|Reported Event|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal.
297557|NCT00897390|E3|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal.
297558|NCT00897390|E2|Reported Event|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
297559|NCT00897390|E1|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions.
297560|NCT00897104|B4|Baseline|Total|Total of all reporting groups
297561|NCT00897104|B3|Baseline|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297562|NCT00897104|B2|Baseline|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297564|NCT00897104|P3|Participant Flow|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297565|NCT00897104|P2|Participant Flow|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297566|NCT00897104|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297567|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297568|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297569|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297570|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297571|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297572|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297573|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297574|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297575|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297576|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297577|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297578|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297579|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297580|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297581|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297582|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297583|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297584|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297585|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297586|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297587|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297588|NCT00897104|E3|Reported Event|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
297589|NCT00897104|E2|Reported Event|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
297590|NCT00897104|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
297591|NCT00896779|B3|Baseline|Total|Total of all reporting groups
297592|NCT00896779|B2|Baseline|Ranibizumab Group 2|Group 2: 6 monthly injecions of 0.5mg then prn
297593|NCT00896779|B1|Baseline|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
297594|NCT00896779|P2|Participant Flow|Ranibizumab Group 2|Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
297595|NCT00896779|P1|Participant Flow|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
297596|NCT00896779|O2|Outcome|Ranibizumab Group 2|Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
297597|NCT00896779|O1|Outcome|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
297598|NCT00896779|E2|Reported Event|Ranibizumab Group 2|Group 2: 6 monthly injections of 0.5 mg then prn
297599|NCT00896779|E1|Reported Event|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
297600|NCT00896649|B1|Baseline|Positron Emission Mammography (PEM), Mammography, Questionaire|"questionnaire administration digital mammography positron emission mammography~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~digital mammography: standard screening mammogram~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
297601|NCT00896649|P1|Participant Flow|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
297602|NCT00896649|O1|Outcome|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
297603|NCT00896649|O1|Outcome|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
297604|NCT00896649|E1|Reported Event|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
297605|NCT00896454|B1|Baseline|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297606|NCT00896454|P1|Participant Flow|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297607|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297608|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297609|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297610|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297611|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297612|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297613|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297614|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297615|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297616|NCT00896454|E1|Reported Event|Denosumab 120 mg Q4W|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
297617|NCT00896337|B1|Baseline|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
297618|NCT00896337|P1|Participant Flow|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
297619|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297620|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297621|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297622|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297623|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297624|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297625|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297626|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297627|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297628|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297629|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297630|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297631|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297632|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297633|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297634|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297635|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297636|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297637|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297638|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297639|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297640|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297641|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297642|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297643|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297644|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297645|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297646|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297647|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297648|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297649|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297650|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297651|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297652|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
297654|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
297655|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
297656|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
297657|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297658|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297659|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297660|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297661|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297662|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297663|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297664|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297665|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297666|NCT00896337|O1|Outcome|Epis Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
297667|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297668|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297669|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297670|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297671|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297672|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297673|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297674|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297675|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297676|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297677|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297678|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297679|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297680|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297681|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297682|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
297683|NCT00896337|E1|Reported Event|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
297684|NCT00896233|B1|Baseline|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
297685|NCT00896233|P1|Participant Flow|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
297686|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
297687|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
297688|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
297689|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
297690|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
297691|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
297692|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
297693|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
297694|NCT00896233|E1|Reported Event|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
297695|NCT00896168|B3|Baseline|Total|Total of all reporting groups
297696|NCT00896168|B2|Baseline|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297697|NCT00896168|B1|Baseline|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297698|NCT00896168|P2|Participant Flow|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297783|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297784|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297699|NCT00896168|P1|Participant Flow|Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA])|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297700|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297701|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297702|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297703|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297704|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297705|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297706|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297707|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297708|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297709|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297710|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297711|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297712|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297713|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297714|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297715|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297716|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297736|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297717|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297718|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297719|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297720|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297721|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297722|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297723|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297724|NCT00896168|E2|Reported Event|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
297725|NCT00896168|E1|Reported Event|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
297726|NCT00896051|B3|Baseline|Total|Total of all reporting groups
297727|NCT00896051|B2|Baseline|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297728|NCT00896051|B1|Baseline|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297729|NCT00896051|P2|Participant Flow|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297730|NCT00896051|P1|Participant Flow|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297731|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297732|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297733|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297734|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297735|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297782|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297737|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297738|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297739|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297740|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297741|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297742|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297743|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297744|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297745|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
297746|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
297747|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
297748|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
297749|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
297750|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
297751|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297752|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297753|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
297754|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297755|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
308442|NCT00860470|B3|Baseline|Total|Total of all reporting groups
297756|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297757|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297758|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297759|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297760|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297761|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297762|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297763|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297764|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297765|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
297766|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
297767|NCT00896051|E2|Reported Event|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297768|NCT00896051|E1|Reported Event|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
297769|NCT00896038|B3|Baseline|Total|Total of all reporting groups
297770|NCT00896038|B2|Baseline|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
297771|NCT00896038|B1|Baseline|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297772|NCT00896038|P2|Participant Flow|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
297773|NCT00896038|P1|Participant Flow|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297774|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297775|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297776|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297777|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297778|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297779|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297780|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297781|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297785|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297786|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297787|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297788|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297789|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297790|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297791|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297792|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297793|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297794|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297795|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297796|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297797|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297798|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297799|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297800|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297801|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297802|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297803|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297804|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297805|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297806|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
297807|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297808|NCT00896038|E2|Reported Event|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
297809|NCT00896038|E1|Reported Event|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
297810|NCT00896025|B1|Baseline|N-acetycylcysteine|Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
297811|NCT00896025|P1|Participant Flow|N-acetycylcysteine|Acute liver failure population
297812|NCT00896025|O1|Outcome|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
297813|NCT00896025|E1|Reported Event|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
297814|NCT00895947|B3|Baseline|Total|Total of all reporting groups
297815|NCT00895947|B2|Baseline|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297816|NCT00895947|B1|Baseline|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297817|NCT00895947|P2|Participant Flow|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297818|NCT00895947|P1|Participant Flow|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297819|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297820|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297821|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297822|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297823|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297824|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297825|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297826|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297827|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297828|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297829|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297830|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297831|NCT00895947|E2|Reported Event|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
297832|NCT00895947|E1|Reported Event|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
297833|NCT00895934|B3|Baseline|Total|Total of all reporting groups
297834|NCT00895934|B2|Baseline|Phase 2/Selected Dose|Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
297835|NCT00895934|B1|Baseline|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
297836|NCT00895934|P2|Participant Flow|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
297837|NCT00895934|P1|Participant Flow|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat orally on days 1-9, azacitidine subcutaneously (SC) or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
297838|NCT00895934|O2|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
297839|NCT00895934|O1|Outcome|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
297840|NCT00895934|E2|Reported Event|Phase 2/Selected Dose|"Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.~Laboratory biomarker analysis: correlative studies"
297841|NCT00895934|E1|Reported Event|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: correlative studies"
297842|NCT00895895|B6|Baseline|Total|Total of all reporting groups
297843|NCT00895895|B5|Baseline|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297844|NCT00895895|B4|Baseline|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297845|NCT00895895|B3|Baseline|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297846|NCT00895895|B2|Baseline|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297847|NCT00895895|B1|Baseline|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297848|NCT00895895|P5|Participant Flow|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297995|NCT00895817|B1|Baseline|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
297849|NCT00895895|P4|Participant Flow|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297850|NCT00895895|P3|Participant Flow|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297851|NCT00895895|P2|Participant Flow|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297852|NCT00895895|P1|Participant Flow|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297853|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297854|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297855|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297856|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297857|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297858|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297859|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297860|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297861|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297862|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297863|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297864|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297865|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297996|NCT00895817|P2|Participant Flow|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
297997|NCT00895817|P1|Participant Flow|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
297866|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297867|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297868|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297869|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297870|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297871|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297872|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297873|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297874|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297875|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297876|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297877|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297878|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297879|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297880|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297881|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297882|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
309419|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
297883|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297884|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297885|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297886|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297887|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297888|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297889|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297890|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297891|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297892|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297893|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297894|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297895|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297896|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297897|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297898|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297899|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297998|NCT00895817|O2|Outcome|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
297999|NCT00895817|O1|Outcome|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
309420|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
297900|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297901|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297902|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297903|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297904|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297905|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297906|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297907|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297908|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297909|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297910|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297911|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297912|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297913|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297914|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297915|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297916|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
298000|NCT00895817|E2|Reported Event|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
298001|NCT00895817|E1|Reported Event|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
298002|NCT00895583|B3|Baseline|Total|Total of all reporting groups
297917|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297918|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297919|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297920|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297921|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297922|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297923|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297924|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297925|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297926|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297927|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297928|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297929|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297930|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297931|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297932|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297933|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
298502|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
297934|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297935|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297936|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297937|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297938|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297939|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297940|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297941|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297942|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297943|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297944|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297945|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297946|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297947|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297948|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297949|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297950|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
298134|NCT00895193|B2|Baseline|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298503|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
297951|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297952|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297953|NCT00895895|E10|Reported Event|Donepezil Period 2|Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
297954|NCT00895895|E9|Reported Event|SAM-531 5.0 mg Period 2|SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297955|NCT00895895|E8|Reported Event|SAM-531 3.0 mg Period 2|SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297956|NCT00895895|E7|Reported Event|SAM-531 1.5 mg Period 2|SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297957|NCT00895895|E6|Reported Event|SAM-531 5.0 mg Crossover Period 2|Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297958|NCT00895895|E5|Reported Event|Donepezil Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
297959|NCT00895895|E4|Reported Event|SAM-531 5.0 mg Period 1|SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297960|NCT00895895|E3|Reported Event|SAM-531 3.0 mg Period 1|SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297961|NCT00895895|E2|Reported Event|SAM-531 1.5 mg Period 1|SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297962|NCT00895895|E1|Reported Event|Placebo/5.0 mg Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
297963|NCT00895843|B3|Baseline|Total|Total of all reporting groups
297964|NCT00895843|B2|Baseline|Brufen Retard|
297965|NCT00895843|B1|Baseline|Conventional Ibuprofen|
297966|NCT00895843|P2|Participant Flow|Brufen Retard|
297967|NCT00895843|P1|Participant Flow|Conventional Ibuprofen|
297968|NCT00895843|O2|Outcome|Brufen Retard|
297969|NCT00895843|O1|Outcome|Conventional Ibuprofen|
297970|NCT00895843|E2|Reported Event|Brufen Retard|
297971|NCT00895843|E1|Reported Event|Conventional Ibuprofen|
297972|NCT00895830|B6|Baseline|Total|Total of all reporting groups
297973|NCT00895830|B5|Baseline|APD405 3mg Dose|
297974|NCT00895830|B4|Baseline|APD405 2mg Dose|
297975|NCT00895830|B3|Baseline|APD405 1mg Dose|
297976|NCT00895830|B2|Baseline|APD405 0.3mg Dose|
297977|NCT00895830|B1|Baseline|Placebo|
297978|NCT00895830|P5|Participant Flow|APD405 3mg Dose|
297979|NCT00895830|P4|Participant Flow|APD405 2mg Dose|
297980|NCT00895830|P3|Participant Flow|APD405 1mg Dose|
297981|NCT00895830|P2|Participant Flow|APD405 0.3mg Dose|
297982|NCT00895830|P1|Participant Flow|Placebo|
297983|NCT00895830|O5|Outcome|APD405 3mg Dose|
297984|NCT00895830|O4|Outcome|APD405 2mg Dose|
297985|NCT00895830|O3|Outcome|APD405 1mg Dose|
297986|NCT00895830|O2|Outcome|APD405 0.3mg Dose|
297987|NCT00895830|O1|Outcome|Placebo|
297988|NCT00895830|E5|Reported Event|APD405 3mg Dose|
297989|NCT00895830|E4|Reported Event|APD405 2mg Dose|
297990|NCT00895830|E3|Reported Event|APD405 1mg Dose|
297991|NCT00895830|E2|Reported Event|APD405 0.3mg Dose|
297992|NCT00895830|E1|Reported Event|Placebo|
297993|NCT00895817|B3|Baseline|Total|Total of all reporting groups
297994|NCT00895817|B2|Baseline|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
298003|NCT00895583|B2|Baseline|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298004|NCT00895583|B1|Baseline|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298005|NCT00895583|P2|Participant Flow|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298006|NCT00895583|P1|Participant Flow|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298007|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298008|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298009|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298010|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298011|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298135|NCT00895193|B1|Baseline|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298136|NCT00895193|P4|Participant Flow|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298504|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298012|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298013|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298014|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298015|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298016|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298017|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298018|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298019|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298020|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298217|NCT00894790|B2|Baseline|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298021|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298022|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298023|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298024|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298025|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298026|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298027|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298028|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298029|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298137|NCT00895193|P3|Participant Flow|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298138|NCT00895193|P2|Participant Flow|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
309421|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
298030|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298031|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298032|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298033|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298034|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298035|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298036|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298037|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298038|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298218|NCT00894790|B1|Baseline|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298039|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298040|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298041|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298042|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298043|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298044|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298045|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298046|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298047|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298139|NCT00895193|P1|Participant Flow|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298140|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298219|NCT00894790|P2|Participant Flow|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298048|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298049|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298050|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298051|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298052|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298053|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298054|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298055|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298056|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298505|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298057|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298058|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298059|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298060|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298061|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298062|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298063|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298064|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298065|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298141|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298142|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
309422|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
298066|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298067|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298068|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298069|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298070|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298071|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298072|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298073|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298074|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298200|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298075|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298076|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298077|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298078|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298079|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298080|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298081|NCT00895583|E2|Reported Event|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298082|NCT00895583|E1|Reported Event|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
298083|NCT00895453|B4|Baseline|Total|Total of all reporting groups
298084|NCT00895453|B3|Baseline|Classic Homeopathy|
298085|NCT00895453|B2|Baseline|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
298086|NCT00895453|B1|Baseline|Itraconazole|itraconazole alone
298087|NCT00895453|P3|Participant Flow|Classic Homeopathy|
298088|NCT00895453|P2|Participant Flow|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
298089|NCT00895453|P1|Participant Flow|Itraconazole|itraconazole alone
298090|NCT00895453|O3|Outcome|Classic Homeopathy|
298091|NCT00895453|O2|Outcome|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
298092|NCT00895453|O1|Outcome|Itraconazole|itraconazole alone
298201|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298093|NCT00895453|E3|Reported Event|Classic Homeopathy (CH)|"CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.~classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000."
298094|NCT00895453|E2|Reported Event|Itraconazole + Lactobacilli Agent|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)~lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days"
298095|NCT00895453|E1|Reported Event|Itraconazole|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)"
298096|NCT00895310|B1|Baseline|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298097|NCT00895310|P1|Participant Flow|Ketoconazole|"Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening)~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298098|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298099|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298100|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298101|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298102|NCT00895310|E1|Reported Event|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
298103|NCT00895284|B3|Baseline|Total|Total of all reporting groups
298104|NCT00895284|B2|Baseline|Standard|Standard hysterectomy
298105|NCT00895284|B1|Baseline|Robot|Robotic hysterectomy
298106|NCT00895284|P2|Participant Flow|Standard|Standard hysterectomy
298107|NCT00895284|P1|Participant Flow|Robot|Robotic hysterectomy
298108|NCT00895284|O2|Outcome|Standard|Standard hysterectomy
298109|NCT00895284|O1|Outcome|Robot|Robotic hysterectomy
298110|NCT00895284|E2|Reported Event|Standard|Standard hysterectomy
298111|NCT00895284|E1|Reported Event|Robot|Robotic hysterectomy
298112|NCT00895232|B4|Baseline|Total|Total of all reporting groups
298113|NCT00895232|B3|Baseline|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298114|NCT00895232|B2|Baseline|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298115|NCT00895232|B1|Baseline|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298116|NCT00895232|P3|Participant Flow|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298117|NCT00895232|P2|Participant Flow|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298118|NCT00895232|P1|Participant Flow|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298119|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298120|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298121|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298122|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298123|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298124|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298125|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298126|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298127|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298128|NCT00895232|E3|Reported Event|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
298129|NCT00895232|E2|Reported Event|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
298130|NCT00895232|E1|Reported Event|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
298131|NCT00895193|B5|Baseline|Total|Total of all reporting groups
298132|NCT00895193|B4|Baseline|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298133|NCT00895193|B3|Baseline|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298143|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298144|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298145|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298146|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298147|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298148|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298149|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298150|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298151|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298152|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298153|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298154|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298155|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298156|NCT00895193|E4|Reported Event|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298157|NCT00895193|E3|Reported Event|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298158|NCT00895193|E2|Reported Event|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298159|NCT00895193|E1|Reported Event|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
298160|NCT00895011|B4|Baseline|Total|Total of all reporting groups
298161|NCT00895011|B3|Baseline|Avanafil 200 mg|
298162|NCT00895011|B2|Baseline|Avanafil 100 mg|
298163|NCT00895011|B1|Baseline|Placebo|
298164|NCT00895011|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
298165|NCT00895011|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
298166|NCT00895011|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
298167|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
298168|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
298169|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
298170|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
298171|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
298172|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
298173|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
298174|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
298175|NCT00895011|O1|Outcome|Placebo|placeb 30 minutes orally prior to initiation of sexual activity
298176|NCT00895011|E3|Reported Event|Avanafil 200 mg|
298177|NCT00895011|E2|Reported Event|Avanafil 100 mg|
298178|NCT00895011|E1|Reported Event|Placebo|
298179|NCT00894803|B3|Baseline|Total|Total of all reporting groups
298180|NCT00894803|B2|Baseline|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298181|NCT00894803|B1|Baseline|Rt-PA Only|rt-PA (0.9 mg/kg)
298182|NCT00894803|P2|Participant Flow|Rt-PA Only|recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)
298183|NCT00894803|P1|Participant Flow|Rt-PA and Eptifibatide|recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
298184|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298185|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298186|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298187|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298188|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298189|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298190|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298191|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298192|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298193|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298194|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298195|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298196|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298197|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
298198|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
298199|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
309423|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
298220|NCT00894790|P1|Participant Flow|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298221|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298222|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298223|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298224|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298225|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298226|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298227|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298228|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298229|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298230|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298231|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298232|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298233|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298234|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298235|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298236|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298237|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298238|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298239|NCT00894790|E2|Reported Event|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
298240|NCT00894790|E1|Reported Event|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
298241|NCT00894699|B3|Baseline|Total|Total of all reporting groups
298242|NCT00894699|B2|Baseline|Placebo|Single dose of Placebo
298243|NCT00894699|B1|Baseline|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
298244|NCT00894699|P2|Participant Flow|Single Dose of Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
298245|NCT00894699|P1|Participant Flow|Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
298246|NCT00894699|O2|Outcome|Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
298247|NCT00894699|O1|Outcome|Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
298248|NCT00894699|E2|Reported Event|Placebo|Single dose of Placebo
298249|NCT00894699|E1|Reported Event|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
298250|NCT00894647|B3|Baseline|Total|Total of all reporting groups
298251|NCT00894647|B2|Baseline|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298252|NCT00894647|B1|Baseline|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298253|NCT00894647|P2|Participant Flow|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298254|NCT00894647|P1|Participant Flow|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298255|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298256|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298257|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298258|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298259|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298260|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298261|NCT00894647|E2|Reported Event|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
298262|NCT00894647|E1|Reported Event|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
298263|NCT00894556|B4|Baseline|Total|Total of all reporting groups
298264|NCT00894556|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
298265|NCT00894556|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
298266|NCT00894556|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
298267|NCT00894556|P4|Participant Flow|Sumatriptan 100 mg|Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
298335|NCT00894465|B2|Baseline|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
298268|NCT00894556|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT"
298269|NCT00894556|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT."
298270|NCT00894556|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo."
298271|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
298272|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
298273|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
298274|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
298275|NCT00894556|E3|Reported Event|Sumatriptan 100 mg|"Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as Baseline Phase"
298276|NCT00894556|E2|Reported Event|Placebo|
298277|NCT00894556|E1|Reported Event|Rizatriptan 10 mg|"Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).~Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.~Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently."
298278|NCT00894543|B3|Baseline|Total|Total of all reporting groups
298279|NCT00894543|B2|Baseline|Placebo|Inactive pill
298280|NCT00894543|B1|Baseline|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298281|NCT00894543|P2|Participant Flow|Placebo|Inactive pill
298282|NCT00894543|P1|Participant Flow|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298283|NCT00894543|O2|Outcome|Placebo|Inactive pill
298284|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298285|NCT00894543|O2|Outcome|Placebo|Inactive pill
298286|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298287|NCT00894543|O2|Outcome|Placebo|Inactive pill
298288|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298289|NCT00894543|O2|Outcome|Placebo|Inactive pill
298290|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298291|NCT00894543|O2|Outcome|Placebo|Inactive pill
298292|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298293|NCT00894543|O2|Outcome|Placebo|Inactive pill
309424|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
298294|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298295|NCT00894543|O2|Outcome|Placebo|Inactive pill
298296|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298297|NCT00894543|O2|Outcome|Placebo|Inactive pill
298298|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298299|NCT00894543|O2|Outcome|Placebo|Inactive pill
298300|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298301|NCT00894543|E2|Reported Event|Placebo|Inactive pill
298302|NCT00894543|E1|Reported Event|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
298303|NCT00894517|B3|Baseline|Total|Total of all reporting groups
298304|NCT00894517|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298305|NCT00894517|B1|Baseline|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298306|NCT00894517|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298307|NCT00894517|P1|Participant Flow|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298308|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298309|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298310|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298311|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298312|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298313|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298314|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298315|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298316|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298317|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298318|NCT00894517|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
298319|NCT00894517|E1|Reported Event|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
298320|NCT00894504|B1|Baseline|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
298321|NCT00894504|P1|Participant Flow|Panitumumab/Gemcitabine/Carboplatin|"Treatment cycles are repeated every 14 days (2 weeks)~Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.~Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle~Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle"
298322|NCT00894504|O8|Outcome|PIK3CA Mutation(s)|
298323|NCT00894504|O7|Outcome|PIK3CA No Mutation|
298324|NCT00894504|O6|Outcome|PTEN Loss|
298325|NCT00894504|O5|Outcome|PTEN Normal|
298326|NCT00894504|O4|Outcome|p53 Loss|
298327|NCT00894504|O3|Outcome|p53 Normal|
298328|NCT00894504|O2|Outcome|EGFR Amplified|
298329|NCT00894504|O1|Outcome|EGFR Normal|
298330|NCT00894504|O1|Outcome|Arm/Group 1|
298331|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Systemic therapy
298332|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
298333|NCT00894504|E1|Reported Event|Panitumumab/Gemcitabine/Carboplatin|
298334|NCT00894465|B3|Baseline|Total|Total of all reporting groups
298368|NCT00894361|B1|Baseline|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
298336|NCT00894465|B1|Baseline|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
298337|NCT00894465|P2|Participant Flow|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
298338|NCT00894465|P1|Participant Flow|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
298339|NCT00894465|O2|Outcome|Placebo|Parents of patients who were given oral placebo prior to undergoing the VCUG.
298340|NCT00894465|O1|Outcome|Versed|Parents of patients who were given oral midazolam prior to undergoing the VCUG.
298341|NCT00894465|O2|Outcome|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
298342|NCT00894465|O1|Outcome|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
298343|NCT00894465|E2|Reported Event|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
298344|NCT00894465|E1|Reported Event|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
298345|NCT00894387|B3|Baseline|Total|Total of all reporting groups
298346|NCT00894387|B2|Baseline|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298347|NCT00894387|B1|Baseline|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298348|NCT00894387|P2|Participant Flow|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298349|NCT00894387|P1|Participant Flow|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298350|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298351|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298352|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298353|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298354|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298355|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298356|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298357|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298358|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298359|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298360|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298361|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298362|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298363|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298364|NCT00894387|E2|Reported Event|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
298365|NCT00894387|E1|Reported Event|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
298366|NCT00894361|B3|Baseline|Total|Total of all reporting groups
298367|NCT00894361|B2|Baseline|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
298369|NCT00894361|P2|Participant Flow|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
298370|NCT00894361|P1|Participant Flow|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
298371|NCT00894361|O2|Outcome|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
298372|NCT00894361|O1|Outcome|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
298373|NCT00894361|E2|Reported Event|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
298374|NCT00894361|E1|Reported Event|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
298375|NCT00894322|B4|Baseline|Total|Total of all reporting groups
298376|NCT00894322|B3|Baseline|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298377|NCT00894322|B2|Baseline|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
298378|NCT00894322|B1|Baseline|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298379|NCT00894322|P3|Participant Flow|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298380|NCT00894322|P2|Participant Flow|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
298381|NCT00894322|P1|Participant Flow|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298382|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298383|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298384|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298385|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298386|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298387|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298388|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298389|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298390|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298391|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298392|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298393|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298394|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298395|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298396|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298397|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298398|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298399|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298400|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298401|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298402|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298403|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298404|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298405|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298406|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298407|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298408|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298499|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298500|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298409|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298410|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298411|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298412|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298413|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298414|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298415|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298416|NCT00894322|E3|Reported Event|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298417|NCT00894322|E2|Reported Event|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
298418|NCT00894322|E1|Reported Event|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
298419|NCT00894244|B1|Baseline|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
298420|NCT00894244|P1|Participant Flow|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
298421|NCT00894244|O1|Outcome|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
298422|NCT00894244|E1|Reported Event|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
298423|NCT00894166|B9|Baseline|Total|Total of all reporting groups
298424|NCT00894166|B8|Baseline|Withdrew Prior to Randomization|These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
298425|NCT00894166|B7|Baseline|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
298426|NCT00894166|B6|Baseline|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
298427|NCT00894166|B5|Baseline|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
298428|NCT00894166|B4|Baseline|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
298429|NCT00894166|B3|Baseline|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
298430|NCT00894166|B2|Baseline|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
298431|NCT00894166|B1|Baseline|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
298432|NCT00894166|P8|Participant Flow|Withdrew Prior to Randomization|"These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.~21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed."
309425|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
298433|NCT00894166|P7|Participant Flow|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298434|NCT00894166|P6|Participant Flow|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298435|NCT00894166|P5|Participant Flow|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298436|NCT00894166|P4|Participant Flow|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298437|NCT00894166|P3|Participant Flow|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298438|NCT00894166|P2|Participant Flow|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298439|NCT00894166|P1|Participant Flow|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298440|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298441|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298442|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298443|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298444|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298445|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298446|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298447|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298448|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298449|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298450|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298451|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
298452|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
298453|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
298454|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
298455|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
298456|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
298457|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
298458|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
298459|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
298460|NCT00894166|O1|Outcome|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
298461|NCT00894166|E7|Reported Event|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
298462|NCT00894166|E6|Reported Event|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
298463|NCT00894166|E5|Reported Event|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
298464|NCT00894166|E4|Reported Event|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
298465|NCT00894166|E3|Reported Event|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
298466|NCT00894166|E2|Reported Event|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
298467|NCT00894166|E1|Reported Event|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
298468|NCT00894127|B1|Baseline|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
298469|NCT00894127|P1|Participant Flow|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
298470|NCT00894127|O1|Outcome|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
298471|NCT00894127|E1|Reported Event|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
298472|NCT00893997|B1|Baseline|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
298473|NCT00893997|P1|Participant Flow|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
298474|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
298475|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
298476|NCT00893997|E1|Reported Event|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
298477|NCT00893789|B5|Baseline|Total|Total of all reporting groups
298478|NCT00893789|B4|Baseline|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298479|NCT00893789|B3|Baseline|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298480|NCT00893789|B2|Baseline|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298481|NCT00893789|B1|Baseline|Placebo|Oral placebo tablets, once daily (QD)
298482|NCT00893789|P4|Participant Flow|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298483|NCT00893789|P3|Participant Flow|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298484|NCT00893789|P2|Participant Flow|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298485|NCT00893789|P1|Participant Flow|Placebo|Oral placebo tablets, once daily (QD)
298486|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298487|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298488|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298489|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298490|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298491|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298492|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298493|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298494|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298495|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298496|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298497|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298498|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
309426|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
298506|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298507|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298508|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298509|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298510|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298511|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298512|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298513|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298514|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298515|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298516|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298517|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298518|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298519|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298520|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298521|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298522|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298523|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298524|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298525|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298526|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298527|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298528|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298529|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298530|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298531|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298532|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298533|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298534|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298535|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298536|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298537|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298538|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298539|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298540|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298541|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298542|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298543|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298544|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298545|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298546|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298547|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298548|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298549|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298550|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298551|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298552|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298553|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298554|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298555|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298556|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298557|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298558|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298559|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298560|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298561|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
298562|NCT00893789|E4|Reported Event|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
298563|NCT00893789|E3|Reported Event|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
298564|NCT00893789|E2|Reported Event|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
298565|NCT00893789|E1|Reported Event|Placebo|Oral placebo tablets, once daily (QD)
298566|NCT00893763|B3|Baseline|Total|Total of all reporting groups
298567|NCT00893763|B2|Baseline|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
298568|NCT00893763|B1|Baseline|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
298569|NCT00893763|P2|Participant Flow|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
298570|NCT00893763|P1|Participant Flow|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
298571|NCT00893763|O2|Outcome|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
298572|NCT00893763|O1|Outcome|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
298573|NCT00893763|O2|Outcome|2: COntrol|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
298574|NCT00893763|O1|Outcome|1: Preintubation Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
298575|NCT00893763|E2|Reported Event|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
298576|NCT00893763|E1|Reported Event|1: Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
298577|NCT00893737|B1|Baseline|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298578|NCT00893737|P1|Participant Flow|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298579|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298580|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298581|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298582|NCT00893737|E1|Reported Event|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
298583|NCT00893464|B9|Baseline|Total|Total of all reporting groups
298584|NCT00893464|B8|Baseline|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298585|NCT00893464|B7|Baseline|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298586|NCT00893464|B6|Baseline|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298587|NCT00893464|B5|Baseline|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298588|NCT00893464|B4|Baseline|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298589|NCT00893464|B3|Baseline|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298590|NCT00893464|B2|Baseline|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298591|NCT00893464|B1|Baseline|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298592|NCT00893464|P8|Participant Flow|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298593|NCT00893464|P7|Participant Flow|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298594|NCT00893464|P6|Participant Flow|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298595|NCT00893464|P5|Participant Flow|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708) 1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298596|NCT00893464|P4|Participant Flow|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298597|NCT00893464|P3|Participant Flow|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298598|NCT00893464|P2|Participant Flow|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298599|NCT00893464|P1|Participant Flow|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity.
298600|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298601|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298786|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298602|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298603|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298604|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298605|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298606|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298607|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298608|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298609|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298610|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298611|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298612|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298613|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298614|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298615|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298616|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298617|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298618|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298619|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298620|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298621|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298622|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298623|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298624|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298625|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298626|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298627|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298628|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298629|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298630|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298631|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298632|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298633|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298634|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298635|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
309427|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
298636|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298637|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298638|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298639|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298640|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298641|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298642|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298643|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298644|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298645|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298646|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298647|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity..
298648|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298649|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298650|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298651|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298652|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298653|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298654|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298655|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298656|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298657|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298658|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298659|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298660|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298661|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298662|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298663|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298664|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298665|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298666|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298667|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298668|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298669|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
309428|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
298670|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298671|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298672|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298673|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298674|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298675|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298676|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298677|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298678|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298679|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298680|NCT00893464|O1|Outcome|All Participants|All participants who received MLN9708 at dose 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 and 3.11 mg/m^2 in Phase 1.
298681|NCT00893464|O1|Outcome|All Participants|All participants who received ixazomib (MLN9708) 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 or 3.11 mg/m^2 in dose-escalation cohorts .
298682|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298683|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298684|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298685|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298686|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298687|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298688|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298689|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298690|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298691|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298692|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298693|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298694|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298695|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298696|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298697|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298698|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m²|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298699|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298700|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298701|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298702|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298703|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298704|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298705|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298706|NCT00893464|E8|Reported Event|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298707|NCT00893464|E7|Reported Event|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298708|NCT00893464|E6|Reported Event|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298709|NCT00893464|E5|Reported Event|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298710|NCT00893464|E4|Reported Event|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298711|NCT00893464|E3|Reported Event|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298712|NCT00893464|E2|Reported Event|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298713|NCT00893464|E1|Reported Event|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
298714|NCT00892437|B3|Baseline|Total|Total of all reporting groups
298715|NCT00892437|B2|Baseline|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298716|NCT00892437|B1|Baseline|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298717|NCT00892437|P2|Participant Flow|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298718|NCT00892437|P1|Participant Flow|ATV+COBI+FTC/TDF|"Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298719|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298720|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298721|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298722|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298723|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298724|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298725|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298726|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298727|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298728|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298729|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298730|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
298731|NCT00892437|E3|Reported Event|All ATV+COBI+FTC/TDF|The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
298732|NCT00892437|E2|Reported Event|ATV+RTV+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60.
298787|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298733|NCT00892437|E1|Reported Event|ATV+COBI+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60.
298734|NCT00893152|B3|Baseline|Total|Total of all reporting groups
298735|NCT00893152|B2|Baseline|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
298736|NCT00893152|B1|Baseline|Veterans|Participants in focus groups or individual qualitative interviews
298737|NCT00893152|P2|Participant Flow|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
298738|NCT00893152|P1|Participant Flow|Veterans|Participants in focus groups or individual qualitative interviews
298739|NCT00893152|O2|Outcome|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
298740|NCT00893152|O1|Outcome|Veterans|Participants in focus groups or individual qualitative interviews
298741|NCT00893152|E2|Reported Event|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
298742|NCT00893152|E1|Reported Event|Veterans|Participants in focus groups or individual qualitative interviews
298743|NCT00893113|B3|Baseline|Total|Total of all reporting groups
298744|NCT00893113|B2|Baseline|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
298745|NCT00893113|B1|Baseline|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
298746|NCT00893113|P2|Participant Flow|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
298747|NCT00893113|P1|Participant Flow|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
298748|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
298749|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
298750|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
298751|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
298752|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
298753|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
298754|NCT00893113|E2|Reported Event|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
298755|NCT00893113|E1|Reported Event|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
298756|NCT00892957|B3|Baseline|Total|Total of all reporting groups
298757|NCT00892957|B2|Baseline|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
298758|NCT00892957|B1|Baseline|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
298759|NCT00892957|P2|Participant Flow|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
298760|NCT00892957|P1|Participant Flow|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
298761|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298762|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298763|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298764|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298765|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298766|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298767|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298768|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298769|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298770|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298771|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298772|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298773|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298774|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298775|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298776|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298777|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298778|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298779|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298780|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298781|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298782|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298783|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298784|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298785|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298788|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298789|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298790|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298791|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298792|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298793|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298794|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298795|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298796|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298797|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298798|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298799|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298800|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298801|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
298802|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
298803|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
298804|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
298805|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298806|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
298807|NCT00892957|O2|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298808|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
298809|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298810|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298811|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298812|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
298813|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298814|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
298815|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298816|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
298817|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298818|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298819|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298820|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
298821|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298822|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
298823|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
298824|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
298825|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298826|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298827|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298828|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298829|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298830|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298831|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298832|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298833|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298834|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298835|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298836|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
309429|NCT00857649|E2|Reported Event|Placebo|Oral Tablets Once Daily
298837|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298838|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298839|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298840|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298841|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
298842|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
298843|NCT00892957|E2|Reported Event|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
298844|NCT00892957|E1|Reported Event|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
298845|NCT00892723|B4|Baseline|Total|Total of all reporting groups
298846|NCT00892723|B3|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298847|NCT00892723|B2|Baseline|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298848|NCT00892723|B1|Baseline|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298849|NCT00892723|P3|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298850|NCT00892723|P2|Participant Flow|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298851|NCT00892723|P1|Participant Flow|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298852|NCT00892723|O9|Outcome|Scar Total Volume - 1 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298853|NCT00892723|O8|Outcome|Scar Total Volume - 0.3 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298854|NCT00892723|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298855|NCT00892723|O6|Outcome|Scar Negative Volume - 1 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298856|NCT00892723|O5|Outcome|Scar Negative Volume - 0.3 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298857|NCT00892723|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298858|NCT00892723|O3|Outcome|Scar Positive Volume - 1 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298859|NCT00892723|O2|Outcome|Scar Positive Volume - 0.3 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 0.3 mg AZx100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298860|NCT00892723|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298861|NCT00892723|O15|Outcome|Scar Mean Elevation - 1 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298862|NCT00892723|O14|Outcome|Scar Mean Elevation - 0.3 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298863|NCT00892723|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298864|NCT00892723|O12|Outcome|Scar Maximum Elevation - 1 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298865|NCT00892723|O11|Outcome|Scar Maximum Elevation - 0.3 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298866|NCT00892723|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298867|NCT00892723|O9|Outcome|Scar Minimum Elevation - 1 mg AZX100|This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298868|NCT00892723|O8|Outcome|Scar Minimum Elevation - 0.3 mg AZX100|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298869|NCT00892723|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298870|NCT00892723|O6|Outcome|Scar Width - 1 mg AZX100|This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298871|NCT00892723|O5|Outcome|Scar Width - 0.3 mg AZX100|This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298872|NCT00892723|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298873|NCT00892723|O3|Outcome|Scar Length - 1 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298874|NCT00892723|O2|Outcome|Scar Length - 0.3 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298875|NCT00892723|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length measurements (mm)for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298876|NCT00892723|O6|Outcome|Rater 2 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298877|NCT00892723|O5|Outcome|Rater 2 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298878|NCT00892723|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298879|NCT00892723|O3|Outcome|Rater 1 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298880|NCT00892723|O2|Outcome|Rater 1 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298881|NCT00892723|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298882|NCT00892723|O6|Outcome|OSAS Results for 1 mg AZX100|This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298883|NCT00892723|O5|Outcome|OSAS Results for 0.3 mg AZX100|This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298884|NCT00892723|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298885|NCT00892723|O3|Outcome|PSAS Results for 1 mg AZX100|This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298886|NCT00892723|O2|Outcome|PSAS Results for 0.3 mg AZX100|This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298887|NCT00892723|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
298888|NCT00892723|E3|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298889|NCT00892723|E2|Reported Event|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298890|NCT00892723|E1|Reported Event|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
298891|NCT00892710|B4|Baseline|Total|Total of all reporting groups
298892|NCT00892710|B3|Baseline|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298893|NCT00892710|B2|Baseline|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298894|NCT00892710|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298895|NCT00892710|P3|Participant Flow|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298896|NCT00892710|P2|Participant Flow|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298897|NCT00892710|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298898|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298899|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298900|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
299045|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
298901|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298902|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298903|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298904|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298905|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298906|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298907|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298908|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298909|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298910|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298911|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298912|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298913|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298914|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298915|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298916|NCT00892710|E3|Reported Event|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
298917|NCT00892710|E2|Reported Event|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
298918|NCT00892710|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
298919|NCT00892697|B1|Baseline|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
298920|NCT00892697|P1|Participant Flow|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
298921|NCT00892697|O1|Outcome|Telaprevir/PEG-IFN/RBV|15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
298922|NCT00892697|O1|Outcome|Telaprevir/Peg-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
298923|NCT00892697|E1|Reported Event|Telaprevir/PEG-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
298924|NCT00892281|B3|Baseline|Total|Total of all reporting groups
298925|NCT00892281|B2|Baseline|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298926|NCT00892281|B1|Baseline|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298927|NCT00892281|P2|Participant Flow|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298928|NCT00892281|P1|Participant Flow|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298929|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298930|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298931|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298932|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298966|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298933|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298934|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298935|NCT00892281|E2|Reported Event|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
298936|NCT00892281|E1|Reported Event|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
298937|NCT00892151|B1|Baseline|Intended Users of the Software|Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
298938|NCT00892151|P1|Participant Flow|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
298939|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
298940|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
298941|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
298942|NCT00892151|E1|Reported Event|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
298943|NCT00892099|B4|Baseline|Total|Total of all reporting groups
298944|NCT00892099|B3|Baseline|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
298945|NCT00892099|B2|Baseline|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
298946|NCT00892099|B1|Baseline|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
298947|NCT00892099|P3|Participant Flow|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
298948|NCT00892099|P2|Participant Flow|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
298949|NCT00892099|P1|Participant Flow|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
298950|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
298951|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
298952|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
298953|NCT00892099|E3|Reported Event|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
298954|NCT00892099|E2|Reported Event|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
298955|NCT00892099|E1|Reported Event|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
298956|NCT00892047|B3|Baseline|Total|Total of all reporting groups
298957|NCT00892047|B2|Baseline|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
298958|NCT00892047|B1|Baseline|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
298959|NCT00892047|P2|Participant Flow|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298960|NCT00892047|P1|Participant Flow|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298961|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298962|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298963|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298964|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298965|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
299044|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
298967|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298968|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298969|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298970|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298971|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
298972|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
298973|NCT00892047|E2|Reported Event|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
298974|NCT00892047|E1|Reported Event|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
298975|NCT00892008|B1|Baseline|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298976|NCT00892008|P1|Participant Flow|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298977|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298978|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298979|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298980|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298981|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298982|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298983|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298984|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298985|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298986|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298987|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298988|NCT00892008|E1|Reported Event|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
298989|NCT00891995|B3|Baseline|Total|Total of all reporting groups
298990|NCT00891995|B2|Baseline|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
298991|NCT00891995|B1|Baseline|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
298992|NCT00891995|P2|Participant Flow|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
298993|NCT00891995|P1|Participant Flow|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
298994|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
298995|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
298996|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
298997|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
298998|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
298999|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299000|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299001|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299002|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299003|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299004|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299005|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299006|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299007|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299008|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299009|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299010|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299011|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299012|NCT00891995|E2|Reported Event|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
299013|NCT00891995|E1|Reported Event|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
299014|NCT00891982|B3|Baseline|Total|Total of all reporting groups
299015|NCT00891982|B2|Baseline|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299016|NCT00891982|B1|Baseline|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299017|NCT00891982|P2|Participant Flow|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299018|NCT00891982|P1|Participant Flow|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299019|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299020|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299021|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299022|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299023|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299024|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299025|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299026|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299027|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299028|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299029|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299030|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299031|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299032|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299033|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299034|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299035|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299036|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299037|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299038|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299039|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299040|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299041|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299042|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299043|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299107|NCT00891774|E1|Reported Event|Device|Treatment with EVOLENCE®
299046|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299047|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299048|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299049|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299050|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299051|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299052|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299053|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299054|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299055|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299056|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299057|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299058|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299059|NCT00891982|E2|Reported Event|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
299060|NCT00891982|E1|Reported Event|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
299061|NCT00891930|B1|Baseline|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299062|NCT00891930|P1|Participant Flow|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299063|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299064|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299065|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299066|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299067|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299068|NCT00891930|O1|Outcome|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299069|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299070|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299071|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299072|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299073|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299074|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299075|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299076|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299077|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299078|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299079|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299080|NCT00891930|E2|Reported Event|Part-2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
299081|NCT00891930|E1|Reported Event|Part-1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
299082|NCT00891904|B1|Baseline|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299083|NCT00891904|P1|Participant Flow|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299084|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299085|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299086|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299087|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299088|NCT00891904|E1|Reported Event|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
299089|NCT00891839|B1|Baseline|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299090|NCT00891839|P1|Participant Flow|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299091|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299092|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299093|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299094|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299095|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299096|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299097|NCT00891839|E1|Reported Event|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
299098|NCT00891813|B1|Baseline|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299099|NCT00891813|P1|Participant Flow|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299100|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299101|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299102|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299103|NCT00891813|E1|Reported Event|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
299104|NCT00891774|B1|Baseline|Device|Treatment with EVOLENCE®
299105|NCT00891774|P1|Participant Flow|Device|Treatment with EVOLENCE®
299106|NCT00891774|O1|Outcome|Device|Treatment with EVOLENCE®
299109|NCT00891735|B4|Baseline|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299110|NCT00891735|B3|Baseline|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299111|NCT00891735|B2|Baseline|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299112|NCT00891735|B1|Baseline|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299113|NCT00891735|P4|Participant Flow|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299114|NCT00891735|P3|Participant Flow|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299115|NCT00891735|P2|Participant Flow|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299116|NCT00891735|P1|Participant Flow|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299117|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299118|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299119|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299120|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299121|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299122|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299123|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299124|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299125|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299126|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299127|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299128|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299129|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299130|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299131|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299132|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299133|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299162|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299207|NCT00891371|E1|Reported Event|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299134|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299135|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299136|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299137|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299138|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299139|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299140|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299141|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299142|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299143|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299144|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299145|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299146|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299147|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299148|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299149|NCT00891735|E4|Reported Event|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
299150|NCT00891735|E3|Reported Event|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
299151|NCT00891735|E2|Reported Event|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
299152|NCT00891735|E1|Reported Event|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
299153|NCT00891657|B3|Baseline|Total|Total of all reporting groups
299154|NCT00891657|B2|Baseline|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299155|NCT00891657|B1|Baseline|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299156|NCT00891657|P2|Participant Flow|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299157|NCT00891657|P1|Participant Flow|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299158|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299159|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299160|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299161|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299163|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299164|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299165|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299166|NCT00891657|E2|Reported Event|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
299167|NCT00891657|E1|Reported Event|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
299168|NCT00891618|B1|Baseline|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
299169|NCT00891618|P1|Participant Flow|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
299170|NCT00891618|O1|Outcome|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
299171|NCT00891618|E1|Reported Event|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
299172|NCT00891462|B4|Baseline|Total|Total of all reporting groups
299173|NCT00891462|B3|Baseline|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
299174|NCT00891462|B2|Baseline|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
299175|NCT00891462|B1|Baseline|Placebo|Inhaled placebo for 12 weeks
299176|NCT00891462|P3|Participant Flow|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
299177|NCT00891462|P2|Participant Flow|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
299178|NCT00891462|P1|Participant Flow|Placebo|Inhaled placebo for 12 weeks
299179|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
299180|NCT00891462|O2|Outcome|Aclidinium Bromide, 200 µg|Aclidinium bromide, 200 µg dose, Oral inhalation, twice per day, for 12 weeks of treatment
299181|NCT00891462|O1|Outcome|Placebo|Dose matched placebo twice per day, inhaled for 12 weeks of treatment
299182|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
299183|NCT00891462|O2|Outcome|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
299184|NCT00891462|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment
299185|NCT00891462|E3|Reported Event|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
299186|NCT00891462|E2|Reported Event|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
299187|NCT00891462|E1|Reported Event|Placebo|Inhaled placebo for 12 weeks
299188|NCT00891436|B3|Baseline|Total|Total of all reporting groups
299189|NCT00891436|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
299190|NCT00891436|B1|Baseline|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
299191|NCT00891436|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
299192|NCT00891436|P1|Participant Flow|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
299193|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
299194|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
299195|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
299196|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
299197|NCT00891436|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
299198|NCT00891436|E1|Reported Event|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
299199|NCT00891371|B1|Baseline|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
299200|NCT00891371|P1|Participant Flow|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
299201|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299202|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299203|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299204|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299205|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299206|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
299208|NCT00891293|B1|Baseline|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299209|NCT00891293|P1|Participant Flow|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299210|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299211|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299212|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299213|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299214|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299215|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299216|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299217|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299218|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299219|NCT00891293|E1|Reported Event|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
299220|NCT00891202|B3|Baseline|Total|Total of all reporting groups
299221|NCT00891202|B2|Baseline|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299222|NCT00891202|B1|Baseline|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299223|NCT00891202|P2|Participant Flow|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299224|NCT00891202|P1|Participant Flow|Eliglustat|Eliglustat tartrate capsule as a single 50 milligram (mg) dose on Day 1 followed by eliglustat tartrate 50 mg capsule twice daily (BID) from Day 2 to Week 4, and then either eliglustat tartrate 50 mg capsule BID (in participants who had a Genz-99067 [active moiety of eliglustat tartrate in plasma] trough plasma concentration greater than or equal to [>=] 5 nanogram per milliliter [ng/mL]) or eliglustat tartrate 100 mg capsule BID (in participants who had a Genz-99067 trough plasma concentration less than [<] 5 ng/mL), up to Week 39. The pharmacokinetic (PK) assessment at Week 2 was used for dose adjustment after Week 4.
299225|NCT00891202|O2|Outcome|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299226|NCT00891202|O1|Outcome|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299227|NCT00891202|O2|Outcome|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299228|NCT00891202|O1|Outcome|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299229|NCT00891202|O2|Outcome|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299230|NCT00891202|O1|Outcome|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299231|NCT00891202|O2|Outcome|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299232|NCT00891202|O1|Outcome|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299233|NCT00891202|O2|Outcome|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299234|NCT00891202|O1|Outcome|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299235|NCT00891202|E2|Reported Event|Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
299236|NCT00891202|E1|Reported Event|Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 52.
299237|NCT00891176|B5|Baseline|Total|Total of all reporting groups
299238|NCT00891176|B4|Baseline|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299239|NCT00891176|B3|Baseline|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299536|NCT00890084|P1|Participant Flow|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299240|NCT00891176|B2|Baseline|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299241|NCT00891176|B1|Baseline|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299242|NCT00891176|P4|Participant Flow|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299243|NCT00891176|P3|Participant Flow|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299244|NCT00891176|P2|Participant Flow|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299245|NCT00891176|P1|Participant Flow|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299246|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299247|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299248|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299249|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299430|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299431|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299537|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299250|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299251|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299252|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299253|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299254|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299255|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299256|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299257|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299258|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299259|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299260|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299538|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299261|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299262|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299263|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299264|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299265|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299266|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299267|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299268|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299269|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299270|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299271|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299539|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299272|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299273|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299274|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299275|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299276|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299277|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299278|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299279|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299280|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299281|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299282|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299283|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299284|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299285|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299286|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299287|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299288|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299289|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299290|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299291|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299292|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299293|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299294|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299295|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299296|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299297|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299298|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299299|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299300|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299301|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299302|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299303|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299304|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299540|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299305|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299306|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299307|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299308|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299309|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299310|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299311|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299312|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299313|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299314|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299315|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299541|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299316|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299317|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299318|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299319|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299320|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299321|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299322|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299323|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299324|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299325|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299326|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299327|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299328|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299329|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299330|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299331|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299332|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299333|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299334|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299335|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299336|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299337|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299338|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299339|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299340|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299341|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299342|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299343|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299344|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299345|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299346|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299347|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299348|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299542|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299349|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299350|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299351|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299352|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299353|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299354|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299355|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299356|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299357|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299358|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299359|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299543|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299360|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299361|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299362|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299363|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299364|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299365|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299366|NCT00891176|E4|Reported Event|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299367|NCT00891176|E3|Reported Event|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
299368|NCT00891176|E2|Reported Event|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299369|NCT00891176|E1|Reported Event|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
299370|NCT00891020|B4|Baseline|Total|Total of all reporting groups
299371|NCT00891020|B3|Baseline|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299372|NCT00891020|B2|Baseline|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299373|NCT00891020|B1|Baseline|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299374|NCT00891020|P3|Participant Flow|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299375|NCT00891020|P2|Participant Flow|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299376|NCT00891020|P1|Participant Flow|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299377|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299378|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299379|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299380|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299381|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299382|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299383|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299384|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299385|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299432|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299544|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299386|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299387|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299388|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299389|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299390|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299391|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299392|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299393|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299394|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299395|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299396|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299397|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299398|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299399|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299400|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299433|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299401|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299402|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299403|NCT00891020|E3|Reported Event|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299404|NCT00891020|E2|Reported Event|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299405|NCT00891020|E1|Reported Event|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
299406|NCT00890981|B3|Baseline|Total|Total of all reporting groups
299407|NCT00890981|B2|Baseline|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299408|NCT00890981|B1|Baseline|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299409|NCT00890981|P2|Participant Flow|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299410|NCT00890981|P1|Participant Flow|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
299411|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299412|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299413|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299414|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299415|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299416|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299417|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299418|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299419|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299420|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299421|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299422|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299423|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299424|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299425|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299426|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299427|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299428|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299429|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299504|NCT00890409|B1|Baseline|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
299434|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299435|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299436|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299437|NCT00890981|E2|Reported Event|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
299438|NCT00890981|E1|Reported Event|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
299439|NCT00890929|B1|Baseline|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299440|NCT00890929|P1|Participant Flow|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299441|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299442|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299443|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299444|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299445|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299446|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299447|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299448|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299449|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299450|NCT00890929|E1|Reported Event|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
299451|NCT00890916|B1|Baseline|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System."
299452|NCT00890916|P1|Participant Flow|Neuroprosthesis System|Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
299453|NCT00890916|O1|Outcome|Neuroprosthesis System|Subjects with the implanted FIRSTHAND/IST-12 System.
299454|NCT00890916|E1|Reported Event|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels."
299455|NCT00890721|B3|Baseline|Total|Total of all reporting groups
299456|NCT00890721|B2|Baseline|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
299457|NCT00890721|B1|Baseline|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
299458|NCT00890721|P2|Participant Flow|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
299459|NCT00890721|P1|Participant Flow|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
299460|NCT00890721|O2|Outcome|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
299461|NCT00890721|O1|Outcome|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
299462|NCT00890721|E2|Reported Event|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
299463|NCT00890721|E1|Reported Event|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
299464|NCT00890695|B3|Baseline|Total|Total of all reporting groups
299465|NCT00890695|B2|Baseline|2 Normal Diet|normal diet arm
299466|NCT00890695|B1|Baseline|1 RUSF|RUSF prescribed for the child for 4 weeks
299534|NCT00890097|E1|Reported Event|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
299467|NCT00890695|P2|Participant Flow|2 Normal Diet|For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.
299468|NCT00890695|P1|Participant Flow|1 Ready to Use Supplementary Food (RUSF)|"Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).~initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."
299469|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299470|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299471|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299472|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299473|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299474|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299475|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299476|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299477|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299478|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299479|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
299480|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
299481|NCT00890695|E2|Reported Event|2 Normal Diet|normal diet arm
299482|NCT00890695|E1|Reported Event|1 RUSF|RUSF prescribed for the child for 4 weeks
299483|NCT00890682|B3|Baseline|Total|Total of all reporting groups
299484|NCT00890682|B2|Baseline|Placebo|Study Drug Injection
299485|NCT00890682|B1|Baseline|Sky0402|Injection of Study Drug
299486|NCT00890682|P2|Participant Flow|Placebo|Injection of 8cc Placebo (single dose)
299487|NCT00890682|P1|Participant Flow|SKY0402|Injection of 8cc SKY0402 (single dose)
299488|NCT00890682|O2|Outcome|Placebo|Single injection of study drug
299489|NCT00890682|O1|Outcome|SKY0402|Single injection of study drug
299490|NCT00890682|E2|Reported Event|Placebo|Study Drug Injection
299491|NCT00890682|E1|Reported Event|Sky0402|Injection of Study Drug
299492|NCT00890656|B1|Baseline|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
299493|NCT00890656|P1|Participant Flow|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
299494|NCT00890656|O1|Outcome|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
299495|NCT00890656|E1|Reported Event|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
299496|NCT00890591|B1|Baseline|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
299497|NCT00890591|P1|Participant Flow|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
299498|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide + Amlodipine|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
299499|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
299500|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
299501|NCT00890591|O1|Outcome|Olmesartan Monotherapy|olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
299502|NCT00890409|B3|Baseline|Total|Total of all reporting groups
299503|NCT00890409|B2|Baseline|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
299505|NCT00890409|P2|Participant Flow|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
299506|NCT00890409|P1|Participant Flow|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
299507|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
299508|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
299509|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
299510|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
299511|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
299512|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
299513|NCT00890201|B3|Baseline|Total|Total of all reporting groups
299514|NCT00890201|B2|Baseline|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
299515|NCT00890201|B1|Baseline|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
299516|NCT00890201|P2|Participant Flow|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
299517|NCT00890201|P1|Participant Flow|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
299518|NCT00890201|O2|Outcome|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
299519|NCT00890201|O1|Outcome|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
299520|NCT00890201|E2|Reported Event|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
299521|NCT00890201|E1|Reported Event|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
299522|NCT00890097|B4|Baseline|Total|Total of all reporting groups
299523|NCT00890097|B3|Baseline|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299524|NCT00890097|B2|Baseline|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299525|NCT00890097|B1|Baseline|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
299526|NCT00890097|P3|Participant Flow|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299527|NCT00890097|P2|Participant Flow|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299528|NCT00890097|P1|Participant Flow|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
299529|NCT00890097|O3|Outcome|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299530|NCT00890097|O2|Outcome|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299531|NCT00890097|O1|Outcome|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
299532|NCT00890097|E3|Reported Event|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299533|NCT00890097|E2|Reported Event|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
299535|NCT00890084|B1|Baseline|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299545|NCT00890084|E1|Reported Event|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
299546|NCT00889928|B1|Baseline|Cholecystectomy|transvaginal cholecystectomy
299547|NCT00889928|P1|Participant Flow|Cholecystectomy|transvaginal cholecystectomy
299548|NCT00889928|O1|Outcome|Transvaginal Cholecystectomy|
299549|NCT00889928|E1|Reported Event|Cholecystectomy|transvaginal cholecystectomy
299550|NCT00889915|B5|Baseline|Total|Total of all reporting groups
299551|NCT00889915|B4|Baseline|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.~The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods."
299552|NCT00889915|B3|Baseline|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299553|NCT00889915|B2|Baseline|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.~The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided."
299554|NCT00889915|B1|Baseline|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.~The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.~The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips."
299555|NCT00889915|P4|Participant Flow|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
299556|NCT00889915|P3|Participant Flow|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299557|NCT00889915|P2|Participant Flow|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
299558|NCT00889915|P1|Participant Flow|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
299559|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
299560|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299561|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
299562|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
299563|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
299564|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299565|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
299566|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
299567|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
299568|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299569|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
299839|NCT00888355|B3|Baseline|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299570|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
299571|NCT00889915|E4|Reported Event|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
299572|NCT00889915|E3|Reported Event|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
299573|NCT00889915|E2|Reported Event|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
299574|NCT00889915|E1|Reported Event|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
299575|NCT00889863|B1|Baseline|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299576|NCT00889863|P2|Participant Flow|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299577|NCT00889863|P1|Participant Flow|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299578|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299579|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299580|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299581|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299582|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299583|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299618|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299584|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299585|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299586|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299587|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299588|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299589|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299590|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299591|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299592|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299593|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299619|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299739|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299594|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299595|NCT00889863|E3|Reported Event|Placebo: Part II|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299596|NCT00889863|E2|Reported Event|Canakinumab: Part II|Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
299597|NCT00889863|E1|Reported Event|Canakinumab: Part I|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
299598|NCT00889824|B1|Baseline|Balcap Group|Each participant received Balcap Tactile prosthesis
299599|NCT00889824|P1|Participant Flow|Balcap Group|"Balcap group~Balcap group; balance prosthesis : vibrotactile stimulation~Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a buzz either in front, back, or either side of their head when they swayed a certain distance from their center.~They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later.~Each patient wore the balcap device a total of six weeks and then returned the device."
299600|NCT00889824|O1|Outcome|Balcap Group|Vibrotactile stimulation exercises with the device over a span of 6 weeks
299601|NCT00889824|E1|Reported Event|Balcap Group|Each participant received Balcap Tactile prosthesis
299602|NCT00889720|B1|Baseline|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299603|NCT00889720|P1|Participant Flow|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299604|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299605|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299606|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299607|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299608|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299609|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299610|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299611|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299612|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299613|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299614|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299615|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299616|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299617|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299620|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299621|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299622|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299623|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299624|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299625|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299626|NCT00889720|E1|Reported Event|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
299627|NCT00889707|B3|Baseline|Total|Total of all reporting groups
299628|NCT00889707|B2|Baseline|Placebo|2% HSA without PRX302
299629|NCT00889707|B1|Baseline|PRX302|0.6 microgram/gram prostate in 2% HSA
299630|NCT00889707|P2|Participant Flow|Placebo|2% (weight/volume) human serum albumin (HSA) without PRX302
299631|NCT00889707|P1|Participant Flow|PRX302|0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)
299632|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
299633|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
299634|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
299635|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
299636|NCT00889707|E2|Reported Event|Placebo|2% HSA without PRX302
299637|NCT00889707|E1|Reported Event|PRX302|0.6 microgram/gram prostate in 2% HSA
299638|NCT00889681|B1|Baseline|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
299639|NCT00889681|P1|Participant Flow|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
299640|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
299641|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
299642|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
299643|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
299644|NCT00889681|E1|Reported Event|Treated With Cryoablation|"This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF (Atrial Fibrillation Drugs  or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.~Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation."
299645|NCT00889603|B1|Baseline|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299646|NCT00889603|P1|Participant Flow|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299647|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299648|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299649|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299650|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299651|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299652|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299653|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299654|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299655|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299656|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299657|NCT00889603|E1|Reported Event|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
299658|NCT00889512|B3|Baseline|Total|Total of all reporting groups
299695|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299740|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299659|NCT00889512|B2|Baseline|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
299660|NCT00889512|B1|Baseline|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
299661|NCT00889512|P2|Participant Flow|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
299662|NCT00889512|P1|Participant Flow|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
299663|NCT00889512|O2|Outcome|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
299664|NCT00889512|O1|Outcome|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
299665|NCT00889512|E2|Reported Event|Group B|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
299666|NCT00889512|E1|Reported Event|Group A|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
299667|NCT00889421|B1|Baseline|Treatment|Patient receiving apremilast.
299668|NCT00889421|P1|Participant Flow|Treatment|Patient receiving apremilast.
299669|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
299670|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
299671|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
299672|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
299673|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
299674|NCT00889421|E1|Reported Event|Treatment|Patient receiving apremilast.
299675|NCT00889330|B3|Baseline|Total|Total of all reporting groups
299676|NCT00889330|B2|Baseline|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299677|NCT00889330|B1|Baseline|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299678|NCT00889330|P2|Participant Flow|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299679|NCT00889330|P1|Participant Flow|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299680|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299681|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299682|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299683|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299684|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299685|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299686|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299687|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299688|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299689|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299690|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299691|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299692|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299693|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299694|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299737|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299696|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299697|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299698|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299699|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299700|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299701|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299702|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299703|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299704|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299705|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299706|NCT00889330|E2|Reported Event|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299707|NCT00889330|E1|Reported Event|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
299708|NCT00889265|B1|Baseline|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
299709|NCT00889265|P1|Participant Flow|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
299710|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
299711|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
299712|NCT00889265|E1|Reported Event|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
299713|NCT00889252|B3|Baseline|Total|Total of all reporting groups
299714|NCT00889252|B2|Baseline|Placebo Lens|contact lens without drug
299715|NCT00889252|B1|Baseline|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299716|NCT00889252|P2|Participant Flow|Placebo Lens|contact lens without drug
299717|NCT00889252|P1|Participant Flow|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299718|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299719|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299720|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299721|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299722|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299723|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299724|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299725|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299726|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299727|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299728|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299729|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299730|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299731|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299732|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299733|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299734|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299735|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299736|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299741|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299742|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299743|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299744|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299745|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299746|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299747|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299748|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299749|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299750|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299751|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299752|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299753|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299754|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
299755|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299756|NCT00889252|E2|Reported Event|Placebo Lens|contact lens without drug
299757|NCT00889252|E1|Reported Event|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
299758|NCT00889200|B1|Baseline|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
299759|NCT00889200|P1|Participant Flow|Open-label Eszopiclone|"Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
299760|NCT00889200|O1|Outcome|Open-label Eszopiclone|After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
299761|NCT00889200|E1|Reported Event|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
299762|NCT00888979|B1|Baseline|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299763|NCT00888979|P1|Participant Flow|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299764|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299765|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299766|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299767|NCT00888979|E1|Reported Event|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
299768|NCT00888940|B3|Baseline|Total|Total of all reporting groups
299769|NCT00888940|B2|Baseline|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
299770|NCT00888940|B1|Baseline|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
299771|NCT00888940|P2|Participant Flow|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
299772|NCT00888940|P1|Participant Flow|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
299773|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
299774|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
299775|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
299776|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
299777|NCT00888940|E2|Reported Event|Cyklokapron|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
299778|NCT00888940|E1|Reported Event|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
299779|NCT00888849|B3|Baseline|Total|Total of all reporting groups
299780|NCT00888849|B2|Baseline|Suturing|4 layered hand-sutured anastomosis
299781|NCT00888849|B1|Baseline|Stapling|
299782|NCT00888849|P2|Participant Flow|Suturing|4 layered hand-sutured anastomosis
299783|NCT00888849|P1|Participant Flow|Stapling|
299784|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
299785|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
299786|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
299787|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
299788|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
299789|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
299790|NCT00888849|E2|Reported Event|Suturing|4 layered hand-sutured anastomosis
299791|NCT00888849|E1|Reported Event|Stapling|
299792|NCT00888654|B1|Baseline|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
299793|NCT00888654|P1|Participant Flow|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
299838|NCT00888355|B4|Baseline|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299905|NCT00888329|E2|Reported Event|Placebo|Placebo
299794|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
299795|NCT00888654|E1|Reported Event|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
299796|NCT00888628|B1|Baseline|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
299797|NCT00888628|P1|Participant Flow|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
299798|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
299799|NCT00888628|E1|Reported Event|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
299800|NCT00888459|B3|Baseline|Total|Total of all reporting groups
299801|NCT00888459|B2|Baseline|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
299802|NCT00888459|B1|Baseline|Active|4 mg nicotine lozenges
299803|NCT00888459|P2|Participant Flow|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
299804|NCT00888459|P1|Participant Flow|Active|4 mg nicotine lozenges
299805|NCT00888459|O2|Outcome|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
299806|NCT00888459|O1|Outcome|Active|4 mg nicotine lozenges
299807|NCT00888459|E2|Reported Event|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
299808|NCT00888459|E1|Reported Event|Active|4 mg nicotine lozenges
299809|NCT00888433|B3|Baseline|Total|Total of all reporting groups
299810|NCT00888433|B2|Baseline|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
299811|NCT00888433|B1|Baseline|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
299812|NCT00888433|P2|Participant Flow|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
299813|NCT00888433|P1|Participant Flow|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
299814|NCT00888433|O2|Outcome|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
299815|NCT00888433|O1|Outcome|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
299816|NCT00888433|E2|Reported Event|2. CONTROL|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
299817|NCT00888433|E1|Reported Event|1. DENERVATION|Renal Denervation and maintenance of anti-hypertensive medications
299818|NCT00888381|B3|Baseline|Total|Total of all reporting groups
299819|NCT00888381|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
299820|NCT00888381|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
299821|NCT00888381|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
299822|NCT00888381|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
299823|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299824|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299825|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299826|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299827|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299828|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299829|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299830|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299831|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299832|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299833|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
299834|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
299835|NCT00888381|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
299836|NCT00888381|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
299837|NCT00888355|B5|Baseline|Total|Total of all reporting groups
299840|NCT00888355|B2|Baseline|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299841|NCT00888355|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
299842|NCT00888355|P4|Participant Flow|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299843|NCT00888355|P3|Participant Flow|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299844|NCT00888355|P2|Participant Flow|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299845|NCT00888355|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
299846|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299847|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299848|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299849|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299850|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299851|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299852|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299853|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299854|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299855|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299856|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299857|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299858|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299859|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299860|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299861|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299862|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299863|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299864|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299865|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299866|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299867|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299868|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299869|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299870|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299871|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299872|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299873|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299874|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299875|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299876|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299877|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299878|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299879|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299880|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299881|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299882|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299883|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299884|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299885|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299886|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299887|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299888|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299889|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299890|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299891|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299892|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299893|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299894|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
299895|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
299896|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
299897|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
299898|NCT00888329|B3|Baseline|Total|Total of all reporting groups
299899|NCT00888329|B2|Baseline|Placebo|Placebo
299900|NCT00888329|B1|Baseline|Aprepitant|40 mg aprepitant
299901|NCT00888329|P2|Participant Flow|Placebo|Placebo
299902|NCT00888329|P1|Participant Flow|Aprepitant|40 mg aprepitant
299903|NCT00888329|O2|Outcome|Placebo|Placebo
299904|NCT00888329|O1|Outcome|Aprepitant|40 mg aprepitant
299908|NCT00888238|P3|Participant Flow|Placebo / Sitagliptin / Sitagliptin|Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
299909|NCT00888238|P2|Participant Flow|Sitagliptin / Placebo / Sitagliptin|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
299910|NCT00888238|P1|Participant Flow|Sitagliptin / Sitagliptin / Placebo|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
299911|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
299912|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
299913|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
299914|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
299915|NCT00888238|E2|Reported Event|Placebo|12 subjects received a single-dose of placebo in 1 period.
299916|NCT00888238|E1|Reported Event|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
299917|NCT00888134|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299918|NCT00888134|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299919|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299920|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Selumetinib: Given PO"
299921|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299922|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299923|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299924|NCT00888134|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
299925|NCT00887978|B3|Baseline|Total|Total of all reporting groups
299926|NCT00887978|B2|Baseline|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
299927|NCT00887978|B1|Baseline|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
299928|NCT00887978|P2|Participant Flow|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
299929|NCT00887978|P1|Participant Flow|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
299930|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299931|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299932|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299933|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299934|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299935|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299936|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299937|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299938|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299939|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299940|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299941|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299942|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299943|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299944|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299945|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299946|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299947|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299948|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299949|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299950|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299951|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299952|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299953|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299954|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299955|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299956|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299957|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299958|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299959|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299960|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
299961|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
299962|NCT00887978|E2|Reported Event|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1 (3.6).
299963|NCT00887978|E1|Reported Event|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1 (1.9).
299964|NCT00887965|B1|Baseline|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299965|NCT00887965|P1|Participant Flow|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299966|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299967|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299968|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299969|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299970|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299971|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299972|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299973|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299974|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299975|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299976|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299977|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299978|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299979|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299980|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299981|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299982|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299983|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299984|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299985|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299986|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299987|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299988|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299989|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299990|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299991|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299992|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299993|NCT00887965|E1|Reported Event|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
299994|NCT00887913|B1|Baseline|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
299995|NCT00887913|P1|Participant Flow|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
299996|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
299997|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
299998|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
299999|NCT00887913|E1|Reported Event|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
300000|NCT00887809|B3|Baseline|Total|Total of all reporting groups
300001|NCT00887809|B2|Baseline|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
300002|NCT00887809|B1|Baseline|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
300003|NCT00887809|P2|Participant Flow|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
300004|NCT00887809|P1|Participant Flow|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
316911|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
300005|NCT00887809|O2|Outcome|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
300006|NCT00887809|O1|Outcome|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
300007|NCT00887809|E2|Reported Event|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
300008|NCT00887809|E1|Reported Event|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
300009|NCT00887744|B1|Baseline|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300010|NCT00887744|P1|Participant Flow|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
300011|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300012|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300013|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300014|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300015|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300016|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
300017|NCT00887744|E1|Reported Event|ITT Analysis|Single group - Aperius
300018|NCT00887679|B1|Baseline|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300019|NCT00887679|P1|Participant Flow|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300020|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300021|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300022|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300023|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300024|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300025|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.
300026|NCT00887679|E1|Reported Event|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
300027|NCT00887653|B1|Baseline|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300028|NCT00887653|P1|Participant Flow|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300029|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300030|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300031|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300168|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300032|NCT00887653|E1|Reported Event|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
300033|NCT00887640|B1|Baseline|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300034|NCT00887640|P1|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300035|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300036|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300037|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300038|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300039|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300040|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300041|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300042|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300043|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300044|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300045|NCT00887640|E1|Reported Event|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
300046|NCT00887588|B3|Baseline|Total|Total of all reporting groups
300047|NCT00887588|B2|Baseline|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300048|NCT00887588|B1|Baseline|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300049|NCT00887588|P2|Participant Flow|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300050|NCT00887588|P1|Participant Flow|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300750|NCT00885352|P2|Participant Flow|Placebo|Placebo to sitagliptin once daily
300051|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300052|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300053|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300054|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300055|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300056|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300057|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300058|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300059|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300060|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300061|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300062|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300063|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300064|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300065|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300066|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300067|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300068|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300069|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300070|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300071|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300072|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300073|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300074|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300075|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300076|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300077|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300078|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300079|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300080|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300081|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300082|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300083|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300084|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300085|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300086|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300087|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300088|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300089|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300090|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300091|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300092|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300093|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300094|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300095|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300096|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300097|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300098|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300099|NCT00887588|E2|Reported Event|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
300100|NCT00887588|E1|Reported Event|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
300101|NCT00887575|B1|Baseline|All Patients|Includes all patients treated at all dose levels
300102|NCT00887575|P3|Participant Flow|Dose Level III|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
300103|NCT00887575|P2|Participant Flow|Dose Level II|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
300104|NCT00887575|P1|Participant Flow|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
300105|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
300106|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
300107|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
300108|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
300109|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
300110|NCT00887575|E1|Reported Event|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
300111|NCT00887562|B4|Baseline|Total|Total of all reporting groups
300112|NCT00887562|B3|Baseline|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300113|NCT00887562|B2|Baseline|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300114|NCT00887562|B1|Baseline|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300115|NCT00887562|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300116|NCT00887562|P2|Participant Flow|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300117|NCT00887562|P1|Participant Flow|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300118|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300119|NCT00887562|O2|Outcome|2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300120|NCT00887562|O1|Outcome|900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300121|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300122|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300123|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300124|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300125|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300126|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300127|NCT00887562|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo - No idebenone"
300128|NCT00887562|E2|Reported Event|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
300129|NCT00887562|E1|Reported Event|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
300130|NCT00887549|B1|Baseline|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300131|NCT00887549|P1|Participant Flow|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300132|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300133|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300134|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300213|NCT00887471|B2|Baseline|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
300135|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300136|NCT00887549|E1|Reported Event|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
300137|NCT00887510|B3|Baseline|Total|Total of all reporting groups
300138|NCT00887510|B2|Baseline|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
300139|NCT00887510|B1|Baseline|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
300140|NCT00887510|P2|Participant Flow|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
300141|NCT00887510|P1|Participant Flow|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
300142|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
300143|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
300144|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
300145|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
300146|NCT00887510|E2|Reported Event|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
300147|NCT00887510|E1|Reported Event|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
300148|NCT00887484|B1|Baseline|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
300149|NCT00887484|P1|Participant Flow|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
300150|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300151|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300152|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300153|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300154|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300155|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300156|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300157|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300158|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300159|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300160|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300161|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300162|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300163|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300164|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300165|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
300166|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300167|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300169|NCT00887484|O1|Outcome|All Subjects|Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
300170|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300171|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300172|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300173|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300174|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300175|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300176|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300177|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300178|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300179|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300180|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300181|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300182|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300183|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300184|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300185|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300186|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300187|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300188|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300189|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300190|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300191|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300192|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300193|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300194|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300195|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300196|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300197|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300198|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300199|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300200|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300201|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300202|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300203|NCT00887484|O2|Outcome|Epiduo|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300204|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300205|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300206|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300207|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300208|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
300209|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300210|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
300211|NCT00887484|E1|Reported Event|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
300212|NCT00887471|B3|Baseline|Total|Total of all reporting groups
300214|NCT00887471|B1|Baseline|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
300215|NCT00887471|P2|Participant Flow|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
300216|NCT00887471|P1|Participant Flow|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
300217|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
300218|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
300219|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
300220|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
300221|NCT00887471|E2|Reported Event|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
300222|NCT00887471|E1|Reported Event|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
300223|NCT00887458|B3|Baseline|Total|Total of all reporting groups
300224|NCT00887458|B2|Baseline|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
300225|NCT00887458|B1|Baseline|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
300226|NCT00887458|P2|Participant Flow|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
300227|NCT00887458|P1|Participant Flow|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
300228|NCT00887458|O2|Outcome|High Dose Itraconazole|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
300229|NCT00887458|O1|Outcome|Low Dose Itraconazole|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
300230|NCT00887458|E2|Reported Event|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
300231|NCT00887458|E1|Reported Event|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
300232|NCT00887354|B3|Baseline|Total|Total of all reporting groups
300233|NCT00887354|B2|Baseline|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300234|NCT00887354|B1|Baseline|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300235|NCT00887354|P2|Participant Flow|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300236|NCT00887354|P1|Participant Flow|Teriparatide|"20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.~Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300237|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300238|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300239|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300240|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300241|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300242|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300243|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300244|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300245|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300246|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300308|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300247|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300248|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300249|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300250|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300251|NCT00887354|E2|Reported Event|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300252|NCT00887354|E1|Reported Event|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
300253|NCT00887341|B3|Baseline|Total|Total of all reporting groups
300254|NCT00887341|B2|Baseline|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300255|NCT00887341|B1|Baseline|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300256|NCT00887341|P2|Participant Flow|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300257|NCT00887341|P1|Participant Flow|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300258|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300259|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300260|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300261|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300262|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300263|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300264|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300265|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300266|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300267|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300268|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300269|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300270|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300271|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
316912|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
300272|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300273|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300274|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300275|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300276|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300277|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300278|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300279|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300280|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300281|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300282|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300283|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300284|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300285|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300286|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300287|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300288|NCT00887341|E2|Reported Event|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
300289|NCT00887341|E1|Reported Event|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
300290|NCT00887315|B3|Baseline|Total|Total of all reporting groups
300291|NCT00887315|B2|Baseline|Chemo and Radiation|Chemotherapy and radiotherapy
300292|NCT00887315|B1|Baseline|Chemo Only|Chemotherapy only
300293|NCT00887315|P2|Participant Flow|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
300294|NCT00887315|P1|Participant Flow|Chemo Only|Chemotherapy only
300295|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
300296|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
300297|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
300298|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
300299|NCT00887315|E2|Reported Event|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
300300|NCT00887315|E1|Reported Event|Chemo Only|Chemotherapy only
300301|NCT00887289|B1|Baseline|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300302|NCT00887289|P1|Participant Flow|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300303|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300304|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300305|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300306|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300307|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300309|NCT00887289|E1|Reported Event|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
300310|NCT00887250|B4|Baseline|Total|Total of all reporting groups
300311|NCT00887250|B3|Baseline|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300312|NCT00887250|B2|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300313|NCT00887250|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
300314|NCT00887250|P3|Participant Flow|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300315|NCT00887250|P2|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300316|NCT00887250|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
300317|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300318|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300319|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300320|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300321|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300322|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300323|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300324|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300325|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300326|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300327|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300328|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300329|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300330|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300331|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300332|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
300333|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
300334|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
300335|NCT00887224|B4|Baseline|Total|Total of all reporting groups
300336|NCT00887224|B3|Baseline|DVS SR 50 mg (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."
300337|NCT00887224|B2|Baseline|Placebo (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."
300338|NCT00887224|B1|Baseline|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
300339|NCT00887224|P3|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
300340|NCT00887224|P2|Participant Flow|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
300341|NCT00887224|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
300342|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300343|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300344|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300345|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300346|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300347|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300348|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
316913|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
300349|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300350|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300351|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300352|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300353|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300354|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
300355|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300356|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300357|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300358|NCT00887224|E7|Reported Event|DVS SR 50 mg (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
300359|NCT00887224|E6|Reported Event|Placebo (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
300360|NCT00887224|E5|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
300361|NCT00887224|E4|Reported Event|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
300362|NCT00887224|E3|Reported Event|DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)|Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
300363|NCT00887224|E2|Reported Event|DVS SR 50 mg (Open Label Stability Phase)|DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
300364|NCT00887224|E1|Reported Event|DVS SR 50 mg (Open-label Response Phase)|DVS SR 50 mg PO QD for 8 weeks.
300365|NCT00887198|B3|Baseline|Total|Total of all reporting groups
300366|NCT00887198|B2|Baseline|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300367|NCT00887198|B1|Baseline|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300368|NCT00887198|P2|Participant Flow|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300369|NCT00887198|P1|Participant Flow|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300370|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300371|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300372|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300373|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300374|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300419|NCT00886938|O1|Outcome|rTMS|rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
316914|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
300375|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300376|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300377|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300378|NCT00887198|O3|Outcome|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
300379|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300380|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300381|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300382|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300383|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300384|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300385|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300386|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300387|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300388|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300389|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300390|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300391|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300392|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300393|NCT00887198|E3|Reported Event|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
300394|NCT00887198|E2|Reported Event|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300395|NCT00887198|E1|Reported Event|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
300396|NCT00887159|B4|Baseline|Total|Total of all reporting groups
300420|NCT00886938|E1|Reported Event|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
300421|NCT00886899|B1|Baseline|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300397|NCT00887159|B3|Baseline|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
300398|NCT00887159|B2|Baseline|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
300399|NCT00887159|B1|Baseline|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
300400|NCT00887159|P3|Participant Flow|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
300401|NCT00887159|P2|Participant Flow|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
300402|NCT00887159|P1|Participant Flow|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
300403|NCT00887159|O2|Outcome|Low CTC Count|Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
300404|NCT00887159|O1|Outcome|High CTC Count|High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
300405|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
300406|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
300407|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
300408|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
300409|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
300410|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
300411|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
300412|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
300413|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
300414|NCT00887159|E3|Reported Event|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
300415|NCT00887159|E2|Reported Event|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
300416|NCT00887159|E1|Reported Event|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
300417|NCT00886938|B1|Baseline|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
300418|NCT00886938|P1|Participant Flow|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
300422|NCT00886899|P1|Participant Flow|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300423|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300424|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300425|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300426|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300427|NCT00886899|E1|Reported Event|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
300428|NCT00886834|B3|Baseline|Total|Total of all reporting groups
300429|NCT00886834|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
300430|NCT00886834|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
300431|NCT00886834|P2|Participant Flow|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
300432|NCT00886834|P1|Participant Flow|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
300433|NCT00886834|O2|Outcome|Placebo|
300434|NCT00886834|O1|Outcome|Misoprostol|
300435|NCT00886834|O2|Outcome|Placebo|
300436|NCT00886834|O1|Outcome|Misoprostol|
300437|NCT00886834|E2|Reported Event|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
300438|NCT00886834|E1|Reported Event|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
300439|NCT00886795|B1|Baseline|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
300440|NCT00886795|P1|Participant Flow|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
300441|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks."
300442|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
300443|NCT00886795|E1|Reported Event|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
300444|NCT00886769|B3|Baseline|Total|Total of all reporting groups
300445|NCT00886769|B2|Baseline|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300446|NCT00886769|B1|Baseline|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300447|NCT00886769|P2|Participant Flow|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300448|NCT00886769|P1|Participant Flow|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300449|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300450|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300451|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300452|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300453|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300454|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300455|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300456|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300457|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300504|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300458|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300459|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300460|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300461|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300462|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300463|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300464|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300465|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300466|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300467|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300468|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300469|NCT00886769|E2|Reported Event|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
300470|NCT00886769|E1|Reported Event|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
300471|NCT00886704|B3|Baseline|Total|Total of all reporting groups
300472|NCT00886704|B2|Baseline|Convenience Drink Without EPA and DHA|
300473|NCT00886704|B1|Baseline|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
300474|NCT00886704|P2|Participant Flow|Convenience Drink Without EPA and DHA|
300475|NCT00886704|P1|Participant Flow|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
300476|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|
300477|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
300478|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|Palatability
300479|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA|Palatability
300480|NCT00886704|E2|Reported Event|Convenience Drink Without EPA and DHA|
300481|NCT00886704|E1|Reported Event|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
300482|NCT00886639|B1|Baseline|6MWT With Different Gas Mixtures|
300483|NCT00886639|P1|Participant Flow|6MWT With Different Gas Mixtures|
300484|NCT00886639|O1|Outcome|Oxygen Response|difference between 6-minute-walking test on oxygen and on medical air
300485|NCT00886639|E1|Reported Event|6MWT With Different Gas Mixtures|
300486|NCT00886626|B1|Baseline|All Participants|All enrolled participants
300487|NCT00886626|P2|Participant Flow|Control Then Exenatide|No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
300488|NCT00886626|P1|Participant Flow|Exenatide Then Control|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
300489|NCT00886626|O2|Outcome|Control|No medication control for 3-months. Participants came from period 1 and period 2.
300490|NCT00886626|O1|Outcome|Exenatide|Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
300491|NCT00886626|E2|Reported Event|Control|No medication control for 3-months.
300492|NCT00886626|E1|Reported Event|Exenatide|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
300493|NCT00886613|B4|Baseline|Total|Total of all reporting groups
300494|NCT00886613|B3|Baseline|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300495|NCT00886613|B2|Baseline|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300496|NCT00886613|B1|Baseline|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300497|NCT00886613|P3|Participant Flow|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300498|NCT00886613|P2|Participant Flow|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300499|NCT00886613|P1|Participant Flow|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300500|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300501|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300502|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300503|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300690|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300505|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300506|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300507|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300508|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300509|NCT00886613|O2|Outcome|Part A Participants - VZV Skin Reaction (72 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 72 hours.
300510|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (48 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 48 hours.
300511|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
300512|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
300513|NCT00886613|E3|Reported Event|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
300514|NCT00886613|E2|Reported Event|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
300515|NCT00886613|E1|Reported Event|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
300516|NCT00886600|B5|Baseline|Total|Total of all reporting groups
300517|NCT00886600|B4|Baseline|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300518|NCT00886600|B3|Baseline|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300519|NCT00886600|B2|Baseline|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300520|NCT00886600|B1|Baseline|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300521|NCT00886600|P4|Participant Flow|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
300522|NCT00886600|P3|Participant Flow|Losartan 100 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks"
300523|NCT00886600|P2|Participant Flow|Losartan 50 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
300524|NCT00886600|P1|Participant Flow|Placebo / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks~Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
300525|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300526|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300527|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300528|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300529|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300530|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300531|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300532|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300533|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300534|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300535|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300747|NCT00885352|B3|Baseline|Total|Total of all reporting groups
300536|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300537|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300538|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300539|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300540|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300541|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300542|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
300543|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300544|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
300545|NCT00886483|B3|Baseline|Total|Total of all reporting groups
300546|NCT00886483|B2|Baseline|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
300547|NCT00886483|B1|Baseline|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
300548|NCT00886483|P2|Participant Flow|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
300549|NCT00886483|P1|Participant Flow|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
300550|NCT00886483|O2|Outcome|Sham Neurofeedback|Participants in the Sham group completing 40 treatments
300551|NCT00886483|O1|Outcome|Active Neurofeedback|All participants in the Active group completing 40 treatments
300552|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
300553|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
300554|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
300555|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
300556|NCT00886483|O2|Outcome|Sham Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
300557|NCT00886483|O1|Outcome|Active Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
300558|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
300559|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
300560|NCT00886483|O2|Outcome|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
300561|NCT00886483|O1|Outcome|Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
300562|NCT00886483|E2|Reported Event|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
300563|NCT00886483|E1|Reported Event|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
300564|NCT00886340|B3|Baseline|Total|Total of all reporting groups
300565|NCT00886340|B2|Baseline|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
300566|NCT00886340|B1|Baseline|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
300567|NCT00886340|P2|Participant Flow|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
300568|NCT00886340|P1|Participant Flow|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
300569|NCT00886340|O2|Outcome|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
300570|NCT00886340|O1|Outcome|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
300571|NCT00886340|E2|Reported Event|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
300572|NCT00886340|E1|Reported Event|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
300573|NCT00886288|B3|Baseline|Total|Total of all reporting groups
300574|NCT00886288|B2|Baseline|Patients With Albuminuria Treated With Telmisartan|baseline population
300575|NCT00886288|B1|Baseline|Patients Without Albuminuria Treated With Telmisartan|baseline population
300576|NCT00886288|P2|Participant Flow|Patients With Albuminuria Treated With Telmisartan|
300577|NCT00886288|P1|Participant Flow|Patients Without Albuminuria Treated With Telmisartan|
300578|NCT00886288|O1|Outcome|Patients With Albuminuria Treated With Telmisartan|
300579|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
300580|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
300581|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
300582|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
300583|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
300584|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
300585|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
300586|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
300587|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
300588|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
300589|NCT00886288|E3|Reported Event||patients without baseline albuminuria data
300590|NCT00886288|E2|Reported Event|Patients With Albuminuria Treated With Telmisartan|
300591|NCT00886288|E1|Reported Event|Patients Without Albuminuria Treated With Telmisartan|
300592|NCT00886145|B1|Baseline|Vibration- Right Leg and No Vibration-left Leg|"The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.~At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
300593|NCT00886145|P1|Participant Flow|Vibration: Right Leg and No Vibration: Left Leg|"The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g.~In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords."
300594|NCT00886145|O2|Outcome|No Vibration- Left Leg|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
300595|NCT00886145|O1|Outcome|Vibration- Right Leg|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
300596|NCT00886145|E2|Reported Event|No Vibration-left Leg:|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
300597|NCT00886145|E1|Reported Event|Vibration- Right Leg:|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
300598|NCT00886119|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
300599|NCT00886119|P2|Participant Flow|Omafilcon A / Lotrafilcon B|Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
300600|NCT00886119|P1|Participant Flow|Lotrafilcon B / Omafilcon A|Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis.
300601|NCT00886119|O2|Outcome|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
300602|NCT00886119|O1|Outcome|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear use
300603|NCT00886119|E2|Reported Event|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
300604|NCT00886119|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear
300605|NCT00885846|B4|Baseline|Total|Total of all reporting groups
300606|NCT00885846|B3|Baseline|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
300607|NCT00885846|B2|Baseline|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300608|NCT00885846|B1|Baseline|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300609|NCT00885846|P3|Participant Flow|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
300610|NCT00885846|P2|Participant Flow|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300611|NCT00885846|P1|Participant Flow|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300612|NCT00885846|O3|Outcome|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
300613|NCT00885846|O2|Outcome|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300614|NCT00885846|O1|Outcome|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
300615|NCT00885846|E3|Reported Event|Control|Wait list group; no activity at this arm. On list to start Qigong
300616|NCT00885846|E2|Reported Event|Progressive Resistance Training|Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
300617|NCT00885846|E1|Reported Event|Qigong Therapy|Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
300618|NCT00885768|B1|Baseline|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
300619|NCT00885768|P1|Participant Flow|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
300620|NCT00885768|O1|Outcome|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
300621|NCT00885768|E1|Reported Event|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
300622|NCT00885755|B4|Baseline|Total|Total of all reporting groups
300623|NCT00885755|B3|Baseline|No Group|This group included participants who died before any on study disease assessments or post-baseline biopsies. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
300624|NCT00885755|B2|Baseline|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300625|NCT00885755|B1|Baseline|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300626|NCT00885755|P3|Participant Flow|No Group|This group included participants who died before any study disease assessments or post-baseline biopsies. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
300627|NCT00885755|P2|Participant Flow|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300628|NCT00885755|P1|Participant Flow|Group A:Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 milligrams per square meter (mg/m^2) or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on Body Surface Area (BSA) on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300748|NCT00885352|B2|Baseline|Placebo|Placebo to sitagliptin once daily
300629|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300630|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300631|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300632|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300633|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300634|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300635|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300678|NCT00885482|E1|Reported Event|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
300679|NCT00885378|B3|Baseline|Total|Total of all reporting groups
300680|NCT00885378|B2|Baseline|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300749|NCT00885352|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily
300636|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300637|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300638|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300639|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300640|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300641|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300642|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300681|NCT00885378|B1|Baseline|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300682|NCT00885378|P2|Participant Flow|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300683|NCT00885378|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300684|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300643|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300644|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300645|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300646|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300647|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300648|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300649|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300685|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300686|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300687|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300688|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300650|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300651|NCT00885755|E1|Reported Event|All Participants|In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Trastuzumab was administered according to SMPC. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
300652|NCT00885742|B1|Baseline|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300653|NCT00885742|P1|Participant Flow|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300654|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300655|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300656|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300657|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300658|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300659|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300660|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300661|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300662|NCT00885742|E1|Reported Event|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
300663|NCT00885638|B1|Baseline|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
300664|NCT00885638|P2|Participant Flow|Sitagliptin First, Then Placebo|First intervention 1 day, washout 14 days, second intervention 1 day
300665|NCT00885638|P1|Participant Flow|Placebo First, Then Sitagliptin|First intervention 1 day, washout 14 days, second intervention 1 day
300666|NCT00885638|O2|Outcome|Sitagliptin|Sitagliptin is given before ingestion of meal
300667|NCT00885638|O1|Outcome|Placebo|A placebo tablet is given before ingestion of meal
300668|NCT00885638|O2|Outcome|Sitagliptin|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
300669|NCT00885638|O1|Outcome|Placebo|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo
300670|NCT00885638|E1|Reported Event|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
300671|NCT00885534|B1|Baseline|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
300672|NCT00885534|P1|Participant Flow|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
300673|NCT00885534|O1|Outcome|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
300674|NCT00885534|E1|Reported Event|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
300675|NCT00885482|B1|Baseline|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
300676|NCT00885482|P1|Participant Flow|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
300677|NCT00885482|O1|Outcome|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
300689|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
316915|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
300691|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300692|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300693|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300694|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300695|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300696|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300697|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300698|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300699|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300700|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300701|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300702|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300703|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300704|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300705|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300706|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300707|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300708|NCT00885378|E2|Reported Event|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
300709|NCT00885378|E1|Reported Event|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
300710|NCT00885365|B3|Baseline|Total|Total of all reporting groups
300711|NCT00885365|B2|Baseline|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300712|NCT00885365|B1|Baseline|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300713|NCT00885365|P2|Participant Flow|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300714|NCT00885365|P1|Participant Flow|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300715|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300716|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300717|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300718|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300719|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300720|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300721|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300722|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300723|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300724|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300725|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300726|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300727|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300728|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300729|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300730|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300731|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300732|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300733|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300734|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300735|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300736|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300737|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300738|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300739|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300740|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300741|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300742|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300743|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300744|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300745|NCT00885365|E2|Reported Event|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
300746|NCT00885365|E1|Reported Event|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
300751|NCT00885352|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily
300752|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
300753|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
300754|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
300755|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
300756|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
300757|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
300758|NCT00885352|E2|Reported Event|Placebo|Placebo to sitagliptin once daily
300759|NCT00885352|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
300760|NCT00885118|B6|Baseline|Total|Total of all reporting groups
300761|NCT00885118|B5|Baseline|Empa 25 mg|Treatment with Empa 25 mg once daily
300762|NCT00885118|B4|Baseline|Empa 10 mg|Treatment with Empa 10 mg once daily
300763|NCT00885118|B3|Baseline|Empa 5 mg|Treatment with Empa 5 mg once daily
300764|NCT00885118|B2|Baseline|Empa 1 mg|Treatment with Empa 1 mg once daily
300765|NCT00885118|B1|Baseline|Placebo|Treatment with placebo once daily
300766|NCT00885118|P5|Participant Flow|Empa 25 mg|Treatment with Empa 25 mg once daily
300767|NCT00885118|P4|Participant Flow|Empa 10 mg|Treatment with Empa 10 mg once daily
300768|NCT00885118|P3|Participant Flow|Empa 5 mg|Treatment with Empa 5 mg once daily
300769|NCT00885118|P2|Participant Flow|Empa 1 mg|Treatment with Empa 1 mg once daily
300770|NCT00885118|P1|Participant Flow|Placebo|Treatment with placebo once daily
300771|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300772|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300773|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300774|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300775|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300776|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300777|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300778|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300779|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300780|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300781|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300782|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300783|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300784|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300785|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300786|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300787|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300788|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300789|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300790|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300791|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300792|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300793|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300794|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300795|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300796|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300797|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300798|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300799|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300800|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300801|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300802|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300803|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300804|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300805|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300806|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300807|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300808|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300809|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300810|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300811|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300812|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300813|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300814|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300815|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300816|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300817|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300818|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300819|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300820|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300821|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300822|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300823|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300824|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300825|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
316916|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
300826|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300827|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300828|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300829|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300830|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300831|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300832|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300833|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300834|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300835|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300836|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300837|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300838|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300839|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300840|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300841|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300842|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300843|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300844|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300845|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300846|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300847|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300848|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300849|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300850|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300851|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300852|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300853|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300854|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300855|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300856|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300857|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300858|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300859|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300860|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300861|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300862|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300863|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300864|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300865|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300866|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300867|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300868|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300869|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300870|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300871|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300872|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300873|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300874|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300875|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300876|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300877|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300878|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300879|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300880|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300881|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300882|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300883|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300884|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300885|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300886|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300887|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300888|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300889|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300890|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300891|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300892|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300893|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300894|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300895|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300896|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
300897|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
300898|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
300899|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
300900|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
300901|NCT00885118|E5|Reported Event|Empa 25 mg|Treatment with Empa 25 mg once daily
300902|NCT00885118|E4|Reported Event|Empa 10 mg|Treatment with Empa 10 mg once daily
300903|NCT00885118|E3|Reported Event|Empa 5 mg|Treatment with Empa 5 mg once daily
300904|NCT00885118|E2|Reported Event|Empa 1 mg|Treatment with Empa 1 mg once daily
300905|NCT00885118|E1|Reported Event|Placebo|Treatment with placebo once daily
300906|NCT00885105|B3|Baseline|Total|Total of all reporting groups
300907|NCT00885105|B2|Baseline|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300908|NCT00885105|B1|Baseline|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300909|NCT00885105|P2|Participant Flow|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300910|NCT00885105|P1|Participant Flow|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300911|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300912|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300913|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300914|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300915|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300916|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300917|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300918|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300919|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300920|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300921|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300922|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300923|NCT00885105|E2|Reported Event|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300924|NCT00885105|E1|Reported Event|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
300925|NCT00885092|B3|Baseline|Total|Total of all reporting groups
300926|NCT00885092|B2|Baseline|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
300927|NCT00885092|B1|Baseline|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
300928|NCT00885092|P2|Participant Flow|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
300929|NCT00885092|P1|Participant Flow|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
300930|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
300931|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
300932|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
300933|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
316917|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
300934|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
300935|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
300936|NCT00885092|E2|Reported Event|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
300937|NCT00885092|E1|Reported Event|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
300938|NCT00885079|B3|Baseline|Total|Total of all reporting groups
300939|NCT00885079|B2|Baseline|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
300940|NCT00885079|B1|Baseline|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
300941|NCT00885079|P2|Participant Flow|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
300942|NCT00885079|P1|Participant Flow|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
300943|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
300944|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
300945|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
300946|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
300947|NCT00885079|E2|Reported Event|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
300948|NCT00885079|E1|Reported Event|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
300949|NCT00884949|B1|Baseline|BMN 110|Dose-Escalation Period:
300950|NCT00884949|P1|Participant Flow|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300951|NCT00884949|O5|Outcome|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
300952|NCT00884949|O4|Outcome|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
300953|NCT00884949|O3|Outcome|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
300954|NCT00884949|O2|Outcome|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
300955|NCT00884949|O1|Outcome|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
300956|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300957|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300958|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300959|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300990|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300991|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
316918|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
300960|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
300961|NCT00884949|E5|Reported Event|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
300962|NCT00884949|E4|Reported Event|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
300963|NCT00884949|E3|Reported Event|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
300964|NCT00884949|E2|Reported Event|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
300965|NCT00884949|E1|Reported Event|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
300966|NCT00884910|B1|Baseline|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
300967|NCT00884910|P1|Participant Flow|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
300968|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
300969|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
300970|NCT00884910|E1|Reported Event|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
300971|NCT00884832|B3|Baseline|Total|Total of all reporting groups
300972|NCT00884832|B2|Baseline|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300973|NCT00884832|B1|Baseline|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300974|NCT00884832|P2|Participant Flow|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300975|NCT00884832|P1|Participant Flow|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300976|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300977|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300978|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300979|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300980|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300981|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300982|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300983|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300984|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300985|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300986|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300987|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300988|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300989|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
301505|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
300992|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300993|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300994|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300995|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300996|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300997|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
300998|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
300999|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
301000|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
301001|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
301002|NCT00884832|E2|Reported Event|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
301003|NCT00884832|E1|Reported Event|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
301004|NCT00884806|B1|Baseline|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
301005|NCT00884806|P1|Participant Flow|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
301006|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
301007|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
301008|NCT00884806|E1|Reported Event|FID 114675A|Investigational multi-purpose contact lens solution
301009|NCT00884793|B1|Baseline|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
301010|NCT00884793|P1|Participant Flow|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
301011|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
301012|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
301013|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
301014|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
301015|NCT00884793|E1|Reported Event|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
301016|NCT00884754|B3|Baseline|Total|Total of all reporting groups
301017|NCT00884754|B2|Baseline|90º Curvature, Malleable Stylet|
301018|NCT00884754|B1|Baseline|Rigid GlideScope Specific Stylet|
301019|NCT00884754|P2|Participant Flow|90º Curvature, Malleable Stylet|
301020|NCT00884754|P1|Participant Flow|Rigid GlideScope Specific Stylet|
301021|NCT00884754|O2|Outcome|90º Curvature, Malleable Stylet|
301022|NCT00884754|O1|Outcome|Rigid GlideScope Specific Stylet|
301023|NCT00884754|E2|Reported Event|90º Curvature, Malleable Stylet|
301024|NCT00884754|E1|Reported Event|Rigid GlideScope Specific Stylet|
301025|NCT00884741|B4|Baseline|Total|Total of all reporting groups
301026|NCT00884741|B3|Baseline|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301027|NCT00884741|B2|Baseline|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
316919|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
301028|NCT00884741|B1|Baseline|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
301029|NCT00884741|P4|Participant Flow|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301030|NCT00884741|P3|Participant Flow|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
301031|NCT00884741|P2|Participant Flow|Step 2 Registration: Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization
301032|NCT00884741|P1|Participant Flow|Step 1 Registration|No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
301033|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301034|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
301035|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301036|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
301037|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301038|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
301039|NCT00884741|E3|Reported Event|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
301040|NCT00884741|E2|Reported Event|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
301041|NCT00884741|E1|Reported Event|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
301042|NCT00884585|B3|Baseline|Total|Total of all reporting groups
301043|NCT00884585|B2|Baseline|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
301044|NCT00884585|B1|Baseline|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301045|NCT00884585|P2|Participant Flow|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
301046|NCT00884585|P1|Participant Flow|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301047|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
301048|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301049|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
301050|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301051|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
301052|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301053|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
301054|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301055|NCT00884585|E2|Reported Event|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
301056|NCT00884585|E1|Reported Event|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
301057|NCT00884390|B3|Baseline|Total|Total of all reporting groups
301058|NCT00884390|B2|Baseline|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
301059|NCT00884390|B1|Baseline|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
301060|NCT00884390|P2|Participant Flow|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
301061|NCT00884390|P1|Participant Flow|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
301062|NCT00884390|O1|Outcome|All Participants With at Least One Prophylaxis Infusion|All enrolled participants with at least one prophylaxis infusion
301063|NCT00884390|O1|Outcome|All Participants With at Least One Bleed|All enrolled participants with at least one bleed.
301064|NCT00884390|O2|Outcome|Participants Following a Prophylaxis Regimen at Baseline|All enrolled participants following a prophylaxis regimen at baseline
301065|NCT00884390|O1|Outcome|Participants Following a Non-prophylaxis Regimen at Baseline|All enrolled participants following an on-demand or preventive regimen at baseline
301066|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
301067|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
301068|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
301069|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
301070|NCT00884390|O1|Outcome|All Participants With Bleeds|Includes any infusion with an associated bleeding episode, regardless of the reason for treatment indicated on the case report form
301071|NCT00884390|O1|Outcome|First Infusion Per Bleed|Includes the first infusion for an associated bleeding episode
301072|NCT00884390|O1|Outcome|Annualized Bleed Rate|ABR by regimen at baseline is summarized for all participants for on-demand regimen, preventive regimen and prophylaxis regimen, respectively
301073|NCT00884390|O2|Outcome|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
301074|NCT00884390|O1|Outcome|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
301075|NCT00884390|E1|Reported Event|All Participants|The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
301076|NCT00884325|B3|Baseline|Total|Total of all reporting groups
301077|NCT00884325|B2|Baseline|Subjects Receiving Placebo|
301078|NCT00884325|B1|Baseline|Subjects Receiving Xyzal|
301079|NCT00884325|P2|Participant Flow|Subjects Receiving Placebo|one tablet taken orally at night for 28 days
301080|NCT00884325|P1|Participant Flow|Subjects Receiving Xyzal|one tablet, 5 mg, taken orally at night for 28 days
301081|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
301082|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
301083|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
301084|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
301085|NCT00884325|E2|Reported Event|Subjects Receiving Placebo|
301086|NCT00884325|E1|Reported Event|Subjects Receiving Xyzal|
301087|NCT00884273|B3|Baseline|Total|Total of all reporting groups
301088|NCT00884273|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301089|NCT00884273|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301090|NCT00884273|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301091|NCT00884273|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301092|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301093|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301094|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301095|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301096|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301097|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301098|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301208|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
316920|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
301099|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301100|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301101|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301102|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301103|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301104|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301105|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301106|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301107|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301108|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301109|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301110|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301111|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301112|NCT00884273|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
301113|NCT00884273|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
301114|NCT00884221|B3|Baseline|Total|Total of all reporting groups
301115|NCT00884221|B2|Baseline|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301209|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301210|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301116|NCT00884221|B1|Baseline|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301117|NCT00884221|P2|Participant Flow|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
301118|NCT00884221|P1|Participant Flow|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
301119|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301120|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301121|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301122|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301123|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301124|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301125|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301126|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301127|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301128|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301211|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301129|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301130|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301131|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301132|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301133|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301134|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301135|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301136|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301137|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301138|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301139|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301140|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301141|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301212|NCT00884065|E2|Reported Event|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301213|NCT00884065|E1|Reported Event|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301214|NCT00884039|B3|Baseline|Total|Total of all reporting groups
301142|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301143|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301144|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301145|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301146|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301147|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301148|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
301149|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301150|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301151|NCT00884221|E2|Reported Event|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301152|NCT00884221|E1|Reported Event|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
301153|NCT00884117|B1|Baseline|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301154|NCT00884117|P1|Participant Flow|All Participants Infected With Influenza|Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301215|NCT00884039|B2|Baseline|15 mg Anecortave Acetate|
301216|NCT00884039|B1|Baseline|30 mg Anecortave Acetate|
301155|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301156|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301157|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301158|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301159|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301160|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301161|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301162|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301163|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301164|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301165|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301166|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301167|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301168|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301169|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301217|NCT00884039|P2|Participant Flow|15 mg Anecortave Acetate|
301170|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301171|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301172|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301173|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301174|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301175|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301176|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301177|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301178|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301179|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301180|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301181|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301182|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301183|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301184|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301185|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301186|NCT00884117|O6|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301187|NCT00884117|O5|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301188|NCT00884117|O4|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301189|NCT00884117|O3|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301190|NCT00884117|O2|Outcome|Children 1 to 5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 1 to 5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301191|NCT00884117|O1|Outcome|Children <1 Year of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301192|NCT00884117|O1|Outcome|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301193|NCT00884117|E2|Reported Event|Participants Not Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301194|NCT00884117|E1|Reported Event|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
301195|NCT00884065|B3|Baseline|Total|Total of all reporting groups
301196|NCT00884065|B2|Baseline|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301197|NCT00884065|B1|Baseline|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301198|NCT00884065|P2|Participant Flow|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301199|NCT00884065|P1|Participant Flow|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301200|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301201|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301202|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301203|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301204|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301205|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301206|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
301207|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
301224|NCT00883779|B2|Baseline|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301225|NCT00883779|B1|Baseline|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301226|NCT00883779|P2|Participant Flow|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301227|NCT00883779|P1|Participant Flow|Placebo|Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301228|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301229|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301230|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301231|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301269|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301232|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301233|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301234|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301235|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301236|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301237|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301238|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301239|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301270|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301506|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301240|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301241|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301242|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301243|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301244|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301245|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301246|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301247|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301271|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301507|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301248|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301249|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301250|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301251|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301252|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301253|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301254|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301255|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301272|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301508|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301256|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301257|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301258|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301259|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301260|NCT00883779|E2|Reported Event|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
301261|NCT00883779|E1|Reported Event|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
301262|NCT00883753|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301263|NCT00883753|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301264|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301265|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301266|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301267|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301268|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301670|NCT00883181|E1|Reported Event|Ovarian|Ovarian Cancer
301273|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301274|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301275|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301276|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301277|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301278|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301279|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301280|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301281|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301282|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301283|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301284|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301285|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301286|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301287|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301288|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301289|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301290|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301291|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301292|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301293|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301294|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301295|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301296|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301297|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301298|NCT00883753|O3|Outcome|Tocilizumab + > 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking more than one DMARD at Core study Baseline.
301299|NCT00883753|O2|Outcome|Tocilizumab + 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking one DMARD at Core study Baseline.
301300|NCT00883753|O1|Outcome|Tocilizumab Monotherapy|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were not taking DMARDS at Core Baseline.
301301|NCT00883753|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
301302|NCT00883740|B1|Baseline|Entire Study Population|Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
301303|NCT00883740|P2|Participant Flow|Pregabalin, Then Placebo|Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
301304|NCT00883740|P1|Participant Flow|Placebo, Then Pregabalin|Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
301305|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301306|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301307|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301308|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301309|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301310|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301311|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301312|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301313|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301314|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301315|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301316|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301317|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301318|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301319|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301320|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301321|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301322|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301323|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301324|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301325|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301326|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301327|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301328|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301671|NCT00883168|B5|Baseline|Total|Total of all reporting groups
301329|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301330|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301331|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301332|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301333|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301334|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301335|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301336|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301337|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301338|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301339|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301340|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301341|NCT00883740|E2|Reported Event|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301342|NCT00883740|E1|Reported Event|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
301343|NCT00883675|B1|Baseline|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
301344|NCT00883675|P1|Participant Flow|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
301345|NCT00883675|O1|Outcome|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
301346|NCT00883675|E1|Reported Event|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
301347|NCT00883558|B1|Baseline|All Randomized Participants|"Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump."
301348|NCT00883558|P3|Participant Flow|Insulin Lispro First, Then INSULIN-PH20 NP|"Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
301349|NCT00883558|P2|Participant Flow|INSULIN-PH20 NP First, Then Insulin Lispro|"Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
301350|NCT00883558|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a 1-month dose titration period.~Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
301351|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301377|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301672|NCT00883168|B4|Baseline|Placebo|placebo nasal spray
301352|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301353|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301354|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301355|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301356|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301357|NCT00883558|E2|Reported Event|Insulin Lispro Treatment Period|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301358|NCT00883558|E1|Reported Event|INSULIN-PH20 NP Treatment Period|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
301359|NCT00883493|B3|Baseline|Total|Total of all reporting groups
301360|NCT00883493|B2|Baseline|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301361|NCT00883493|B1|Baseline|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301362|NCT00883493|P2|Participant Flow|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301363|NCT00883493|P1|Participant Flow|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301364|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301365|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301366|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301367|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301368|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301369|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301370|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301371|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301372|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301373|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301374|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301375|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301376|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
316921|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
301378|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301379|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301380|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301381|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301382|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301383|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301384|NCT00883493|E2|Reported Event|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
301385|NCT00883493|E1|Reported Event|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
301386|NCT00883389|B1|Baseline|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
301387|NCT00883389|P1|Participant Flow|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
301388|NCT00883389|O1|Outcome|Med-alert Pilot Group|Participants in pilot study assigned a med-alert device of bracelet or necklace
301389|NCT00883389|E1|Reported Event|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
301390|NCT00883337|B4|Baseline|Total|Total of all reporting groups
301391|NCT00883337|B3|Baseline|IFNβ1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
301392|NCT00883337|B2|Baseline|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
301393|NCT00883337|B1|Baseline|Teriflunomide 7 mg / 14 mg|"Core treatment period: Teriflunomide 7 mg once daily~Extension treatment period: Teriflunomide 14 mg once daily"
301394|NCT00883337|P3|Participant Flow|IFN-β-1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
301395|NCT00883337|P2|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
301396|NCT00883337|P1|Participant Flow|Teriflunomide 7 mg/14 mg|"Core treatment period: Teriflunomide 7 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
301397|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
301398|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
301399|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
301400|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
301401|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
301402|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
301403|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301404|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301405|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301406|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301407|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301408|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301409|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301410|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301411|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301412|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301413|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301414|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301415|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301416|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301417|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301418|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
301419|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
301420|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
301421|NCT00883337|E6|Reported Event|Extended Treatment: Teriflunomide 14 mg (After IFN-β-1a)|Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
301504|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301422|NCT00883337|E5|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 14 mg)|Teriflunomide 14 mg once daily in extended treatment period after 14 mg in core treatment period (mean exposure of 1015.32 days).
301423|NCT00883337|E4|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 7 mg)|Teriflunomide 14 mg once daily in extended treatment period after 7 mg in the core treatment period (mean exposure of 996.76 days).
301424|NCT00883337|E3|Reported Event|Core Treatment: IFN-β-1a|Interferon β-1a 3 times a week (mean exposure of 405.18 days).
301425|NCT00883337|E2|Reported Event|Core Treatment:Teriflunomide 14 mg|Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
301426|NCT00883337|E1|Reported Event|Core Treatment Period: Teriflunomide 7 mg|Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
301427|NCT00883246|B1|Baseline|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301428|NCT00883246|P1|Participant Flow|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301429|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
301430|NCT00883246|O1|Outcome|CLI Subgroup|Wound healing was assessed in subjects who had Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
301431|NCT00883246|O1|Outcome|Claudicant Subjects|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
301432|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
301433|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
301434|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301435|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301436|NCT00883246|O2|Outcome|Claudicant Subgroup (One Year)|"All claudicant subjects (RCC 1-3) enrolled in this single-arm study were treated with directional atherectomy and walking distance measured at the one year follow-up visit.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301437|NCT00883246|O1|Outcome|Claudicant Subgroup (Baseline)|"All claudicant subjects enrolled in this single-arm study were treated with directional atherectomy and had walking distance measured prior to treatment.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301438|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301439|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301440|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301441|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301442|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
301443|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
301444|NCT00883246|E1|Reported Event|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
301445|NCT00883233|B5|Baseline|Total|Total of all reporting groups
301446|NCT00883233|B4|Baseline|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
301447|NCT00883233|B3|Baseline|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
301448|NCT00883233|B2|Baseline|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
301449|NCT00883233|B1|Baseline|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
301450|NCT00883233|P4|Participant Flow|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
301451|NCT00883233|P3|Participant Flow|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
301452|NCT00883233|P2|Participant Flow|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
301453|NCT00883233|P1|Participant Flow|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
301454|NCT00883233|O4|Outcome|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
301455|NCT00883233|O3|Outcome|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
301456|NCT00883233|O2|Outcome|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
301673|NCT00883168|B3|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
301457|NCT00883233|O1|Outcome|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
301458|NCT00883233|E4|Reported Event|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
301459|NCT00883233|E3|Reported Event|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
301460|NCT00883233|E2|Reported Event|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
301461|NCT00883233|E1|Reported Event|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
301462|NCT00883181|B1|Baseline|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301463|NCT00883181|P1|Participant Flow|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301464|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301465|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301466|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301467|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301468|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301469|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301470|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301471|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301472|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301473|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301474|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301475|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301476|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301477|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301478|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301479|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301480|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301481|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301482|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301483|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301484|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301485|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301486|NCT00883181|O2|Outcome|No ESA Use|Participants who did not receive treatment with a erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
301487|NCT00883181|O1|Outcome|Any ESA Use|Participants who received treatment with any erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
301488|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301489|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301490|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
301491|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301492|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301493|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301494|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301495|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301496|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301497|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301498|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301499|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301500|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301501|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301502|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301503|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301674|NCT00883168|B2|Baseline|Azelastine Hcl|azelastine HCl nasal spray
301509|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301510|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301511|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301512|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301513|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301514|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301515|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301516|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301517|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301518|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301519|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301520|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301521|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301522|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301523|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301524|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301525|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301526|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301527|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301528|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301529|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301530|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301531|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301532|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301533|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301534|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301535|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301536|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301537|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301538|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301539|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301540|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301541|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301542|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301543|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301544|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301545|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301546|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301547|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301548|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301549|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301550|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301551|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301552|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301553|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301554|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301555|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301556|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301557|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301558|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301559|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301560|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301561|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
316922|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
301562|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301563|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301564|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301565|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301566|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301567|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301568|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301569|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301570|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301571|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301572|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301573|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301574|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301575|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301576|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301577|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301578|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301579|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301580|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301581|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301582|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301583|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301584|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301585|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301586|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301587|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301588|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301589|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301590|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301591|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301592|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301593|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301594|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301595|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301596|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301597|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301598|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301599|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301600|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301601|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301602|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301603|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301604|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301605|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301606|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301607|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301608|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301609|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301610|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301611|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301612|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301613|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301614|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
316923|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
301615|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301616|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301617|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301618|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301619|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301620|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301621|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301622|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301623|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301624|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301625|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301626|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301627|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301628|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301629|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301630|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301631|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301632|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301633|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301634|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301635|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301636|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301637|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301638|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301639|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301640|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301641|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301642|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301643|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301644|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301645|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301646|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301647|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301648|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301649|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301650|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301651|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301652|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301653|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301654|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301655|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301656|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301657|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301658|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301659|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
301660|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
301661|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
301662|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
301663|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
301664|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
301665|NCT00883181|E6|Reported Event|Breast Total|All Breast Cancer
301666|NCT00883181|E5|Reported Event|Breast Metastatic|Breast Cancer, Metastatic
301667|NCT00883181|E4|Reported Event|Breast Stage I-III|Breast Cancer, Stages I-III
301668|NCT00883181|E3|Reported Event|SCLC|Small Cell Lung Cancer
301669|NCT00883181|E2|Reported Event|NSCLC|Non-small Cell Lung Cancer
301675|NCT00883168|B1|Baseline|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301676|NCT00883168|P4|Participant Flow|Placebo|placebo nasal spray
301677|NCT00883168|P3|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
301678|NCT00883168|P2|Participant Flow|Azelastine Hcl|azelastine HCl nasal spray
301679|NCT00883168|P1|Participant Flow|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301680|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
301681|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
301682|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
301683|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301684|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
301685|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
301686|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
301687|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301688|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
301689|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
301690|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
301691|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301692|NCT00883168|E4|Reported Event|Placebo|placebo nasal spray
301693|NCT00883168|E3|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
301694|NCT00883168|E2|Reported Event|Azelastine Hcl|azelastine HCl nasal spray
301695|NCT00883168|E1|Reported Event|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
301696|NCT00883129|B3|Baseline|Total|Total of all reporting groups
301697|NCT00883129|B2|Baseline|Cyclophosphamide Arm|"Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301698|NCT00883129|B1|Baseline|Mycophenolate Arm|"Participants will receive oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301699|NCT00883129|P2|Participant Flow|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301700|NCT00883129|P1|Participant Flow|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301701|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301702|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301703|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301704|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301705|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301706|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301707|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301708|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301709|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301710|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301772|NCT00882908|P5|Participant Flow|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301979|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
301711|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301712|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301713|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301714|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301715|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301716|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301717|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301718|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301719|NCT00883129|E2|Reported Event|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
301720|NCT00883129|E1|Reported Event|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
301721|NCT00883116|B3|Baseline|Total|Total of all reporting groups
301722|NCT00883116|B2|Baseline|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301723|NCT00883116|B1|Baseline|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
301724|NCT00883116|P2|Participant Flow|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301725|NCT00883116|P1|Participant Flow|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
301726|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301727|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
301728|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301729|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
301730|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301731|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
301773|NCT00882908|P4|Participant Flow|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
316924|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
301732|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301733|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
301734|NCT00883116|E3|Reported Event|Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)|Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.
301735|NCT00883116|E2|Reported Event|Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)|Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
301736|NCT00883116|E1|Reported Event|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
301737|NCT00883103|B3|Baseline|Total|Total of all reporting groups
301738|NCT00883103|B2|Baseline|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301739|NCT00883103|B1|Baseline|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301740|NCT00883103|P2|Participant Flow|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301741|NCT00883103|P1|Participant Flow|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301742|NCT00883103|O2|Outcome|Aqueous Gel|Aqueous gel was applied to the Q-tip and the catheter before insertion.
301743|NCT00883103|O1|Outcome|Lidocaine|Lidocaine gel was applied to the Q-tip and the catheter before insertion.
301744|NCT00883103|E2|Reported Event|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301745|NCT00883103|E1|Reported Event|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
301746|NCT00883090|B1|Baseline|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301747|NCT00883090|P1|Participant Flow|FXIII|All subjects treated with Factor XIII Concentrate (Human) (FXIII)
301748|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301749|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301750|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301751|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301752|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301753|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301754|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301755|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301756|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301757|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301758|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301759|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301760|NCT00883090|E1|Reported Event|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
301761|NCT00882921|B1|Baseline|Elaprase® (0.5 mg/kg)|
301762|NCT00882921|P1|Participant Flow|Elaprase® (0.5 mg/kg)|
301763|NCT00882921|O1|Outcome|Elaprase|"Idursulfase 0.5 mg/kg Weekly~Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS."
301764|NCT00882921|O1|Outcome|Idursulfase (Elaprase) 0.5 mg/kg Weekly|Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
301765|NCT00882921|E1|Reported Event|Elaprase® (0.5 mg/kg)|
301766|NCT00882908|B6|Baseline|Total|Total of all reporting groups
301767|NCT00882908|B5|Baseline|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301768|NCT00882908|B4|Baseline|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301769|NCT00882908|B3|Baseline|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301770|NCT00882908|B2|Baseline|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301771|NCT00882908|B1|Baseline|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301774|NCT00882908|P3|Participant Flow|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301775|NCT00882908|P2|Participant Flow|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301776|NCT00882908|P1|Participant Flow|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301777|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301778|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301779|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301780|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301781|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301782|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301783|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301784|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301785|NCT00882908|O5|Outcome|All TMC435 Treatment Groups|Participants in all 4 TMC435 treatment groups combined.
301786|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301787|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301788|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301789|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301790|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301791|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301792|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301793|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301794|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301795|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301796|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301797|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301798|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301799|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301800|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301801|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301802|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301803|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301804|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301805|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301806|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301807|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301808|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301809|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301810|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301811|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301812|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301813|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301814|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301815|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301816|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301817|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301909|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
316925|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
301818|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301819|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301820|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301821|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301822|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301823|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301824|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301825|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301826|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301827|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301828|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301829|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301830|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301831|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301832|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301833|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301834|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301835|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301836|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301837|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301838|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301839|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301840|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301841|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301842|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301843|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301844|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301845|NCT00882908|E5|Reported Event|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
301846|NCT00882908|E4|Reported Event|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301847|NCT00882908|E3|Reported Event|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301848|NCT00882908|E2|Reported Event|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301849|NCT00882908|E1|Reported Event|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
301850|NCT00882778|B1|Baseline|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301851|NCT00882778|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301852|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301853|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301854|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301855|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301856|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301857|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301858|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301910|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301859|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301860|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301861|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301862|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301863|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301864|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301865|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301866|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301867|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301868|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301869|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301870|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301871|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301872|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301873|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301874|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301911|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301875|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301876|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301877|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301878|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301879|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301880|NCT00882778|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
301881|NCT00882713|B1|Baseline|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301882|NCT00882713|P1|Participant Flow|C.E.R.A.|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301883|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301884|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301885|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301886|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301887|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301888|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301889|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301912|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301913|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301890|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301891|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301892|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301893|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301894|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301895|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301896|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301897|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301898|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301899|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301900|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301901|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301902|NCT00882713|E1|Reported Event|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
301903|NCT00882557|B3|Baseline|Total|Total of all reporting groups
301904|NCT00882557|B2|Baseline|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
301905|NCT00882557|B1|Baseline|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
301906|NCT00882557|P2|Participant Flow|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
301907|NCT00882557|P1|Participant Flow|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
301908|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
316926|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
301914|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301915|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301916|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301917|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301918|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301919|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301920|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
301921|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
301922|NCT00882557|E2|Reported Event|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
301923|NCT00882557|E1|Reported Event|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
301924|NCT00882518|B3|Baseline|Total|Total of all reporting groups
301925|NCT00882518|B2|Baseline|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
301926|NCT00882518|B1|Baseline|Seroquel_XR|Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
301927|NCT00882518|P2|Participant Flow|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
301928|NCT00882518|P1|Participant Flow|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
301929|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301930|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301931|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301932|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301933|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301934|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301935|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301936|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301937|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301976|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
301977|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
301978|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
301938|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301939|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301940|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301941|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301942|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301943|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301944|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301945|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
301946|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
301947|NCT00882518|E2|Reported Event|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
301948|NCT00882518|E1|Reported Event|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
301949|NCT00882440|B8|Baseline|Total|Total of all reporting groups
301950|NCT00882440|B7|Baseline|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
301951|NCT00882440|B6|Baseline|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
301952|NCT00882440|B5|Baseline|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
301953|NCT00882440|B4|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
301954|NCT00882440|B3|Baseline|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
301955|NCT00882440|B2|Baseline|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
301956|NCT00882440|B1|Baseline|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
301957|NCT00882440|P7|Participant Flow|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
301958|NCT00882440|P6|Participant Flow|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
301959|NCT00882440|P5|Participant Flow|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
301960|NCT00882440|P4|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
301961|NCT00882440|P3|Participant Flow|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
301962|NCT00882440|P2|Participant Flow|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
301963|NCT00882440|P1|Participant Flow|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
301964|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
301965|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
301966|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
301967|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
301968|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
301969|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
301970|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
301971|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
301972|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
301973|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
301974|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
301975|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
301980|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
301981|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
301982|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
301983|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
301984|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
301985|NCT00882362|B3|Baseline|Total|Total of all reporting groups
301986|NCT00882362|B2|Baseline|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
301987|NCT00882362|B1|Baseline|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
301988|NCT00882362|P2|Participant Flow|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
301989|NCT00882362|P1|Participant Flow|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
301990|NCT00882362|O2|Outcome|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
301991|NCT00882362|O1|Outcome|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
301992|NCT00882362|E2|Reported Event|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
301993|NCT00882362|E1|Reported Event|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
301994|NCT00882310|B1|Baseline|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
301995|NCT00882310|P1|Participant Flow|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
301996|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
301997|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
301998|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
301999|NCT00882310|E1|Reported Event|Gemcitabine, Docetaxel, Capecitabine GTX|"GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.~AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated)."
302000|NCT00882206|B1|Baseline|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
302001|NCT00882206|P1|Participant Flow|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
302002|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
302027|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302028|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302029|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302003|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
302004|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
302005|NCT00882206|O1|Outcome|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
302006|NCT00882206|E1|Reported Event|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)"
302007|NCT00882102|B1|Baseline|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
302008|NCT00882102|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
302009|NCT00882102|O1|Outcome|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
302010|NCT00882102|E1|Reported Event|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
302011|NCT00881959|B3|Baseline|Total|Total of all reporting groups
302012|NCT00881959|B2|Baseline|Group 2: Alloderm|"Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
302013|NCT00881959|B1|Baseline|Group 1: Puros Dermis|"Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
302014|NCT00881959|P2|Participant Flow|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
302015|NCT00881959|P1|Participant Flow|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
302016|NCT00881959|O2|Outcome|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
302017|NCT00881959|O1|Outcome|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
302018|NCT00881959|E2|Reported Event|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
302019|NCT00881959|E1|Reported Event|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
302020|NCT00881894|B3|Baseline|Total|Total of all reporting groups
302021|NCT00881894|B2|Baseline|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
302022|NCT00881894|B1|Baseline|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
302023|NCT00881894|P2|Participant Flow|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
302024|NCT00881894|P1|Participant Flow|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
302025|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302026|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302094|NCT00881647|B2|Baseline|Waitlist|Participants placed on a waitlist for 8 weeks.
302030|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302031|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302032|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302033|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302034|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302035|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302036|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302037|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302038|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302039|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302040|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302041|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302042|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302043|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302044|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302045|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302046|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302047|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302048|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302049|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302050|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302051|NCT00881894|E2|Reported Event|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
302052|NCT00881894|E1|Reported Event|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
302053|NCT00881868|B3|Baseline|Total|Total of all reporting groups
302054|NCT00881868|B2|Baseline|Vehicle Spray|
302055|NCT00881868|B1|Baseline|Clobex Spray|
302056|NCT00881868|P2|Participant Flow|Vehicle Spray|
302057|NCT00881868|P1|Participant Flow|Clobex Spray|
302058|NCT00881868|O2|Outcome|Vehicle Spray|
302059|NCT00881868|O1|Outcome|Clobex Spray|
302060|NCT00881868|O2|Outcome|Vehicle Spray|
302061|NCT00881868|O1|Outcome|Clobex Spray|
302062|NCT00881868|O2|Outcome|Vehicle Spray|
302063|NCT00881868|O1|Outcome|Clobex Spray|
302064|NCT00881868|O2|Outcome|Vehicle Spray|
302065|NCT00881868|O1|Outcome|Clobex Spray|
302066|NCT00881868|E2|Reported Event|Vehicle Spray|
302067|NCT00881868|E1|Reported Event|Clobex Spray|
302068|NCT00881712|B4|Baseline|Total|Total of all reporting groups
302069|NCT00881712|B3|Baseline|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302070|NCT00881712|B2|Baseline|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302231|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302071|NCT00881712|B1|Baseline|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302072|NCT00881712|P3|Participant Flow|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302073|NCT00881712|P2|Participant Flow|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302074|NCT00881712|P1|Participant Flow|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302075|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302076|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302077|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302078|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302079|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302080|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302081|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302082|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302083|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302084|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302085|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302086|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302087|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302088|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302089|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302090|NCT00881712|E3|Reported Event|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
302091|NCT00881712|E2|Reported Event|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
302092|NCT00881712|E1|Reported Event|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
302093|NCT00881647|B3|Baseline|Total|Total of all reporting groups
302095|NCT00881647|B1|Baseline|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302096|NCT00881647|P2|Participant Flow|Waitlist|Participants placed on a waitlist for 8 weeks.
302097|NCT00881647|P1|Participant Flow|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302098|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
302099|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302100|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
302101|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302102|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
302103|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302104|NCT00881647|E2|Reported Event|Waitlist|Participants placed on a waitlist for 8 weeks.
302105|NCT00881647|E1|Reported Event|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
302106|NCT00881608|B6|Baseline|Total|Total of all reporting groups
302107|NCT00881608|B5|Baseline|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302108|NCT00881608|B4|Baseline|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302109|NCT00881608|B3|Baseline|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302110|NCT00881608|B2|Baseline|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302111|NCT00881608|B1|Baseline|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
302112|NCT00881608|P1|Participant Flow|All Subjects Enrolled|All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
302113|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302114|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302115|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302116|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302117|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
302118|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302119|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302120|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302121|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302122|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
302123|NCT00881608|E5|Reported Event|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302232|NCT00881335|E2|Reported Event|Control Group|without any intervention
316927|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
302124|NCT00881608|E4|Reported Event|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302125|NCT00881608|E3|Reported Event|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302126|NCT00881608|E2|Reported Event|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
302127|NCT00881608|E1|Reported Event|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
302128|NCT00881530|B7|Baseline|Total|Total of all reporting groups
302129|NCT00881530|B6|Baseline|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302130|NCT00881530|B5|Baseline|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302131|NCT00881530|B4|Baseline|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302132|NCT00881530|B3|Baseline|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302133|NCT00881530|B2|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302134|NCT00881530|B1|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302135|NCT00881530|P6|Participant Flow|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302136|NCT00881530|P5|Participant Flow|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302137|NCT00881530|P4|Participant Flow|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302138|NCT00881530|P3|Participant Flow|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302139|NCT00881530|P2|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302140|NCT00881530|P1|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302141|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302142|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302143|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302144|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302145|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302146|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302147|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302148|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302149|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302150|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302151|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302152|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302233|NCT00881335|E1|Reported Event|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302234|NCT00881205|B3|Baseline|Total|Total of all reporting groups
302153|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302154|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302155|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302156|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302157|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302158|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302159|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302160|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302161|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302162|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302163|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302164|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302165|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302166|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302167|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302168|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302169|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302170|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302171|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302172|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302173|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302174|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302175|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302176|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302177|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302178|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302179|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302180|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302181|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302182|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302235|NCT00881205|B2|Baseline|Placebo|Matching the size, shape and color of rivastigmine patches.
302183|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302184|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302185|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302186|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302187|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302188|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302189|NCT00881530|E6|Reported Event|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302190|NCT00881530|E5|Reported Event|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302191|NCT00881530|E4|Reported Event|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
302192|NCT00881530|E3|Reported Event|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
302193|NCT00881530|E2|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
302194|NCT00881530|E1|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
302195|NCT00881504|B1|Baseline|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
302196|NCT00881504|P1|Participant Flow|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
302197|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
302198|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
302199|NCT00881504|E1|Reported Event|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
302200|NCT00881465|B3|Baseline|Total|Total of all reporting groups
302201|NCT00881465|B2|Baseline|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302202|NCT00881465|B1|Baseline|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302203|NCT00881465|P2|Participant Flow|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302236|NCT00881205|B1|Baseline|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
302237|NCT00881205|P2|Participant Flow|Placebo|Matching the size, shape and color of rivastigmine patches.
302238|NCT00881205|P1|Participant Flow|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
302239|NCT00881205|O2|Outcome|Placebo|Matching the size, shape and color of rivastigmine patches.
302787|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302204|NCT00881465|P1|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302205|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302206|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302207|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302208|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302209|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302210|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302211|NCT00881465|E2|Reported Event|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
302212|NCT00881465|E1|Reported Event|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
302213|NCT00881335|B3|Baseline|Total|Total of all reporting groups
302214|NCT00881335|B2|Baseline|Control Group|without any intervention
302215|NCT00881335|B1|Baseline|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302216|NCT00881335|P2|Participant Flow|Control Group|without any intervention
302217|NCT00881335|P1|Participant Flow|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302218|NCT00881335|O2|Outcome|Control Group|without any intervention
302219|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302220|NCT00881335|O2|Outcome|Control Group|without any intervention
302221|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302222|NCT00881335|O2|Outcome|Control Group|without any intervention
302223|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302224|NCT00881335|O2|Outcome|Control Group|without any intervention
302225|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302226|NCT00881335|O2|Outcome|Control Group|without any intervention
302227|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302228|NCT00881335|O2|Outcome|Control Group|without any intervention
302229|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
302230|NCT00881335|O2|Outcome|Control Group|without any intervention
302240|NCT00881205|O1|Outcome|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
302241|NCT00881205|E3|Reported Event|Placebo|Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
302242|NCT00881205|E2|Reported Event|Rivastigmine|Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
302243|NCT00881205|E1|Reported Event|Total Patients|Total Patients
302244|NCT00880919|B4|Baseline|Total|Total of all reporting groups
302245|NCT00880919|B3|Baseline|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302246|NCT00880919|B2|Baseline|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302247|NCT00880919|B1|Baseline|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302248|NCT00880919|P3|Participant Flow|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302249|NCT00880919|P2|Participant Flow|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302250|NCT00880919|P1|Participant Flow|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302251|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302252|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302253|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302254|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302255|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302256|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302257|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302258|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302259|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302260|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302261|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302262|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302263|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302264|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302265|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302266|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302267|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302268|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302269|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302270|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302271|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302272|NCT00880919|O3|Outcome|Placebo (n=29)|"Equivalent number of placebo oral tablets taken daily for 8 weeks.~Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
302273|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33)|"Seroquel XR 300mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
302274|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33)|"Seroquel XR 150mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
302275|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302276|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302277|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302278|NCT00880919|E3|Reported Event|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
302279|NCT00880919|E2|Reported Event|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
302280|NCT00880919|E1|Reported Event|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
302281|NCT00880906|B3|Baseline|Total|Total of all reporting groups
302282|NCT00880906|B2|Baseline|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
302283|NCT00880906|B1|Baseline|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
302284|NCT00880906|P2|Participant Flow|Group B Drug Therapy Only|Receives steroids and PPI only- Does not have esophageal dilation.
302285|NCT00880906|P1|Participant Flow|Group A Drug Therapy Plus Dilation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
302286|NCT00880906|O2|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
302287|NCT00880906|O1|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
302288|NCT00880906|E2|Reported Event|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
302345|NCT00880698|B4|Baseline|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302289|NCT00880906|E1|Reported Event|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
302290|NCT00880763|B5|Baseline|Total|Total of all reporting groups
302291|NCT00880763|B4|Baseline|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302292|NCT00880763|B3|Baseline|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302293|NCT00880763|B2|Baseline|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302294|NCT00880763|B1|Baseline|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302295|NCT00880763|P4|Participant Flow|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302296|NCT00880763|P3|Participant Flow|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302297|NCT00880763|P2|Participant Flow|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302298|NCT00880763|P1|Participant Flow|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302299|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302300|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302301|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302302|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302303|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302304|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302305|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302306|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302307|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302308|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302309|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302310|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302311|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302312|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302313|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302314|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302315|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302316|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302317|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302318|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302319|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302320|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302321|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302322|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302323|NCT00880763|E4|Reported Event|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302324|NCT00880763|E3|Reported Event|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302325|NCT00880763|E2|Reported Event|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302326|NCT00880763|E1|Reported Event|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
302327|NCT00880750|B3|Baseline|Total|Total of all reporting groups
302328|NCT00880750|B2|Baseline|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
302329|NCT00880750|B1|Baseline|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
302330|NCT00880750|P2|Participant Flow|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
302331|NCT00880750|P1|Participant Flow|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
302332|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302333|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302334|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302335|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302336|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302337|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302338|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302339|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302340|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302341|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302342|NCT00880750|E2|Reported Event|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302343|NCT00880750|E1|Reported Event|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
302344|NCT00880698|B5|Baseline|Total|Total of all reporting groups
302416|NCT00880568|P5|Participant Flow|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302346|NCT00880698|B3|Baseline|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302347|NCT00880698|B2|Baseline|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302348|NCT00880698|B1|Baseline|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302349|NCT00880698|P4|Participant Flow|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302350|NCT00880698|P3|Participant Flow|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302351|NCT00880698|P2|Participant Flow|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302352|NCT00880698|P1|Participant Flow|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302353|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302354|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302355|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302356|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302357|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302358|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302359|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302360|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302361|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302362|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302363|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302364|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302365|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302366|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302417|NCT00880568|P4|Participant Flow|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302367|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302368|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302369|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302370|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302371|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
302372|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
302373|NCT00880698|E4|Reported Event|HIV-1 Infected Placebo|
302374|NCT00880698|E3|Reported Event|HIV-1 Infected RotaTeq|
302375|NCT00880698|E2|Reported Event|HIV-1 Uninfected Placebo|
302376|NCT00880698|E1|Reported Event|HIV-1 Uninfected RotaTeq|
302377|NCT00880685|B1|Baseline|Memantine 10mg-30mg|10mg-30mg
302378|NCT00880685|P1|Participant Flow|Memantine 10mg-30mg|10mg-30mg
302379|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
302380|NCT00880685|O1|Outcome|Memantine|"Memantine 10-30mg~Memantine: 10-30mg, daily for 8 weeks"
302381|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
302382|NCT00880685|E3|Reported Event|Memantine 30mg|30mg
302383|NCT00880685|E2|Reported Event|Memantine 20mg|20mg
302384|NCT00880685|E1|Reported Event|Memantine 10mg|10mg
302385|NCT00880620|B5|Baseline|Total|Total of all reporting groups
302386|NCT00880620|B4|Baseline|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
302387|NCT00880620|B3|Baseline|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
302388|NCT00880620|B2|Baseline|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
302389|NCT00880620|B1|Baseline|Placebo|Placebo capsules were used
302390|NCT00880620|P4|Participant Flow|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
302391|NCT00880620|P3|Participant Flow|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
302392|NCT00880620|P2|Participant Flow|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
302393|NCT00880620|P1|Participant Flow|Placebo|Placebo capsules were used
302394|NCT00880620|O4|Outcome|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
302395|NCT00880620|O3|Outcome|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
302396|NCT00880620|O2|Outcome|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
302397|NCT00880620|O1|Outcome|Placebo|Placebo capsules were used
302398|NCT00880620|E4|Reported Event|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
302399|NCT00880620|E3|Reported Event|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
302400|NCT00880620|E2|Reported Event|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
302401|NCT00880620|E1|Reported Event|Placebo|Placebo capsules were used
302402|NCT00880568|B10|Baseline|Total|Total of all reporting groups
302403|NCT00880568|B9|Baseline|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302404|NCT00880568|B8|Baseline|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302405|NCT00880568|B7|Baseline|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302406|NCT00880568|B6|Baseline|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302407|NCT00880568|B5|Baseline|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302408|NCT00880568|B4|Baseline|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302409|NCT00880568|B3|Baseline|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302410|NCT00880568|B2|Baseline|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302411|NCT00880568|B1|Baseline|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302412|NCT00880568|P9|Participant Flow|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302413|NCT00880568|P8|Participant Flow|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302414|NCT00880568|P7|Participant Flow|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302415|NCT00880568|P6|Participant Flow|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302466|NCT00880555|P6|Participant Flow|Non-AD Dementia|Other causes of dementia
302418|NCT00880568|P3|Participant Flow|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302419|NCT00880568|P2|Participant Flow|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302420|NCT00880568|P1|Participant Flow|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302421|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302422|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302423|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302424|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302425|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302426|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302427|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302428|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302429|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302430|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302431|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302432|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302433|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302434|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302435|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302436|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302437|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302438|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302439|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302440|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302441|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302442|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302443|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302444|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302445|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302446|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302447|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302448|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302449|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302450|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302451|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302452|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302453|NCT00880568|E9|Reported Event|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302454|NCT00880568|E8|Reported Event|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302455|NCT00880568|E7|Reported Event|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302456|NCT00880568|E6|Reported Event|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302457|NCT00880568|E5|Reported Event|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
302458|NCT00880568|E4|Reported Event|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
302459|NCT00880568|E3|Reported Event|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
302460|NCT00880568|E2|Reported Event|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
302461|NCT00880568|E1|Reported Event|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
302462|NCT00880555|B4|Baseline|Total|Total of all reporting groups
302463|NCT00880555|B3|Baseline|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
302464|NCT00880555|B2|Baseline|Arm 2: Control|Elderly controls without memory impairment
302465|NCT00880555|B1|Baseline|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
302467|NCT00880555|P5|Participant Flow|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
302468|NCT00880555|P4|Participant Flow|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
302469|NCT00880555|P3|Participant Flow|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
302470|NCT00880555|P2|Participant Flow|Arm 2: Control|Elderly controls without memory impairment
302471|NCT00880555|P1|Participant Flow|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
302472|NCT00880555|O3|Outcome|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
302473|NCT00880555|O2|Outcome|Arm 2: Control|Elderly controls without memory impairment
302474|NCT00880555|O1|Outcome|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
302475|NCT00880555|E6|Reported Event|Non-AD Dementia|Other causes of dementia
302476|NCT00880555|E5|Reported Event|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
302477|NCT00880555|E4|Reported Event|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
302478|NCT00880555|E3|Reported Event|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
302479|NCT00880555|E2|Reported Event|Arm 2: Control|Elderly controls without memory impairment
302480|NCT00880555|E1|Reported Event|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
302481|NCT00880542|B1|Baseline|Sorafenib + Ifosfamide|
302482|NCT00880542|P1|Participant Flow|Sorafenib + Ifosfamide|
302483|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
302484|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
302485|NCT00880542|E1|Reported Event|Sorafenib + Ifosfamide|
302486|NCT00880425|B1|Baseline|Chronic Daily Headache|Patients who fulfilled criteria for Chronic Migraine, New Daily Persistent Headache , Chronic Post Traumatic Headache or Chronic Tension Type Headache
302487|NCT00880425|P2|Participant Flow|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302488|NCT00880425|P1|Participant Flow|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302489|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302490|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302491|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302492|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302493|NCT00880425|E2|Reported Event|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302494|NCT00880425|E1|Reported Event|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
302495|NCT00880360|B1|Baseline|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
302496|NCT00880360|P1|Participant Flow|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
302497|NCT00880360|O1|Outcome|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
302498|NCT00880360|E1|Reported Event|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
302499|NCT00880334|B3|Baseline|Total|Total of all reporting groups
302500|NCT00880334|B2|Baseline|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302501|NCT00880334|B1|Baseline|Vandetanib & Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302502|NCT00880334|P2|Participant Flow|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302503|NCT00880334|P1|Participant Flow|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302504|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302505|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302506|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302507|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302508|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
302509|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
302510|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302671|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302511|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302512|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Placebo orally and docetaxel intravenously~Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
302513|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
302514|NCT00880334|E2|Reported Event|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
302515|NCT00880334|E1|Reported Event|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
302516|NCT00880269|B3|Baseline|Total|Total of all reporting groups
302517|NCT00880269|B2|Baseline|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302518|NCT00880269|B1|Baseline|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302519|NCT00880269|P2|Participant Flow|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302520|NCT00880269|P1|Participant Flow|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302521|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302522|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302523|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302524|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302525|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302526|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302527|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302528|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302529|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302530|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302531|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302532|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302533|NCT00880269|E2|Reported Event|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
302534|NCT00880269|E1|Reported Event|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
302535|NCT00880256|B1|Baseline|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
302536|NCT00880256|P1|Participant Flow|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
302537|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
302538|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
302539|NCT00880256|E1|Reported Event|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
302540|NCT00880230|B1|Baseline|Scuba Iliac Stent System|"Device: Scuba™ Iliac stent~Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302541|NCT00880230|P1|Participant Flow|Scuba Iliac Stent System|"Device: Scuba Iliac Stent~Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302542|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302543|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302857|NCT00879775|B3|Baseline|Total|Total of all reporting groups
302544|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302545|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302546|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302547|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302548|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302549|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302550|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302551|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302552|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302553|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302554|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302555|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302556|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302557|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302558|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302559|NCT00880230|E1|Reported Event|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
302560|NCT00880191|B3|Baseline|Total|Total of all reporting groups
302561|NCT00880191|B2|Baseline|Placebo|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > placebo: Given orally
302562|NCT00880191|B1|Baseline|Gabapentin|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > gabapentin: Given orally
302563|NCT00880191|P2|Participant Flow|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302564|NCT00880191|P1|Participant Flow|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302565|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302566|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302567|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302568|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302569|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
316928|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
302570|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302571|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302572|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302573|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302574|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302575|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302576|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302577|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
302578|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
302579|NCT00880191|E2|Reported Event|Placebo|placebo: Given orally
302580|NCT00880191|E1|Reported Event|Gabapentin|gabapentin: Given orally
302581|NCT00880165|B3|Baseline|Total|Total of all reporting groups
302582|NCT00880165|B2|Baseline|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302583|NCT00880165|B1|Baseline|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302584|NCT00880165|P2|Participant Flow|Home Unattended Testing|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
302585|NCT00880165|P1|Participant Flow|In-laboratory Testing|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
302586|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302587|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302588|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302589|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302590|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302591|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302592|NCT00880165|E2|Reported Event|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302593|NCT00880165|E1|Reported Event|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
302594|NCT00880100|B1|Baseline|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302595|NCT00880100|P1|Participant Flow|Ultrase® MT12|Patients received usual pancreatic enzymes therapy for 9 to 14 days during baseline phase followed by Ultrase® MT12 capsules orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302596|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302597|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302598|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302599|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302600|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302601|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302602|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302603|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302604|NCT00880100|E1|Reported Event|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
302605|NCT00880022|B3|Baseline|Total|Total of all reporting groups
302606|NCT00880022|B2|Baseline|Arm, Trunck and Chest Compression|
302607|NCT00880022|B1|Baseline|Arm Compression Only|
302608|NCT00880022|P2|Participant Flow|Arm, Trunk and Chest Compression|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
302609|NCT00880022|P1|Participant Flow|Arm Compression Only|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
302610|NCT00880022|O2|Outcome|Arm, Trunck and Chest Compression|
302611|NCT00880022|O1|Outcome|Arm Compression Only|
302612|NCT00880022|E2|Reported Event|Arm, Trunck and Chest Compression|
302613|NCT00880022|E1|Reported Event|Arm Compression Only|
302614|NCT00880009|B1|Baseline|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302615|NCT00880009|P1|Participant Flow|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302616|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302617|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302618|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302619|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302620|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302621|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302622|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302623|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302624|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302625|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302626|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302627|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302628|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302629|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302630|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302631|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302632|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302633|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302634|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302635|NCT00880009|E1|Reported Event|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
302636|NCT00879996|B3|Baseline|Total|Total of all reporting groups
302637|NCT00879996|B2|Baseline|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302638|NCT00879996|B1|Baseline|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302639|NCT00879996|P2|Participant Flow|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302640|NCT00879996|P1|Participant Flow|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302641|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302642|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302643|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302644|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302645|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302646|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302647|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302648|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day divided in 2-4 doses for 6 months
302649|NCT00879996|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
302650|NCT00879996|E1|Reported Event|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
302651|NCT00879970|B4|Baseline|Total|Total of all reporting groups
302652|NCT00879970|B3|Baseline|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302653|NCT00879970|B2|Baseline|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302654|NCT00879970|B1|Baseline|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302655|NCT00879970|P5|Participant Flow|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
302656|NCT00879970|P4|Participant Flow|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
302657|NCT00879970|P3|Participant Flow|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302658|NCT00879970|P2|Participant Flow|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302659|NCT00879970|P1|Participant Flow|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302660|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302661|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302662|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302663|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302664|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302665|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302666|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302667|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302668|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302669|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302670|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
316929|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
302672|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302673|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302674|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302675|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302676|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302677|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302678|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302679|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302680|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302681|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302682|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302683|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302684|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302685|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302686|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302687|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302688|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302689|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302690|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302691|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302692|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302693|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302694|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302695|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302696|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302697|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302698|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302699|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302700|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302701|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302702|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302703|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302704|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302705|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302706|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302707|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302708|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302709|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302710|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302711|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302712|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302713|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302714|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302715|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302716|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302717|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302718|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302719|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302720|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
302721|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
302722|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302723|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302724|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302725|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
302726|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
302727|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302728|NCT00879970|O2|Outcome|Pioglitzaone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302729|NCT00879970|O1|Outcome|Placebo|PLACEBO Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302730|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
302731|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
302732|NCT00879970|O3|Outcome|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302733|NCT00879970|O2|Outcome|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302734|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302735|NCT00879970|E5|Reported Event|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
302736|NCT00879970|E4|Reported Event|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days
302737|NCT00879970|E3|Reported Event|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
302738|NCT00879970|E2|Reported Event|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
302739|NCT00879970|E1|Reported Event|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
302740|NCT00879879|B1|Baseline|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
302741|NCT00879879|P1|Participant Flow|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
302742|NCT00879879|O1|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
302743|NCT00879879|E1|Reported Event|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
302744|NCT00879814|B5|Baseline|Total|Total of all reporting groups
302745|NCT00879814|B4|Baseline|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302746|NCT00879814|B3|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302747|NCT00879814|B2|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302748|NCT00879814|B1|Baseline|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302749|NCT00879814|P4|Participant Flow|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302750|NCT00879814|P3|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302751|NCT00879814|P2|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302752|NCT00879814|P1|Participant Flow|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302753|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302754|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302755|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302756|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302757|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302758|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302759|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302760|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302761|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302762|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302763|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302764|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302765|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302766|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302767|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302768|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302769|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302770|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302771|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302772|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302773|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302774|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302775|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302776|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302777|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302778|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302779|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302780|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302781|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302782|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302783|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302784|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302785|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302786|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302788|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302789|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302790|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302791|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302792|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302793|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302794|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302795|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302796|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302797|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302798|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302799|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302800|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302801|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302802|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302803|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302804|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302805|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302806|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302807|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302808|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302809|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302810|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302811|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302812|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302813|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302814|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302815|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302816|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302817|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302818|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302819|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302820|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302821|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302822|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302823|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302824|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302825|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302826|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302827|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302828|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302829|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302830|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302831|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302832|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302833|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302834|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302835|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302836|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302837|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302838|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302839|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302840|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302841|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302842|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302843|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302844|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302845|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302846|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302847|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302848|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302849|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302850|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302851|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302852|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302853|NCT00879814|E4|Reported Event|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
302854|NCT00879814|E3|Reported Event|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
302855|NCT00879814|E2|Reported Event|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
302856|NCT00879814|E1|Reported Event|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
302858|NCT00879775|B2|Baseline|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302859|NCT00879775|B1|Baseline|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302860|NCT00879775|P2|Participant Flow|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302861|NCT00879775|P1|Participant Flow|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302862|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302863|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302864|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302865|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302866|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302867|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302868|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302869|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302870|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302871|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302872|NCT00879775|E2|Reported Event|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
302873|NCT00879775|E1|Reported Event|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
302874|NCT00879710|B3|Baseline|Total|Total of all reporting groups
302875|NCT00879710|B2|Baseline|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302876|NCT00879710|B1|Baseline|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302877|NCT00879710|P4|Participant Flow|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
302878|NCT00879710|P3|Participant Flow|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
302879|NCT00879710|P2|Participant Flow|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
302880|NCT00879710|P1|Participant Flow|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
302881|NCT00879710|O2|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302882|NCT00879710|O1|Outcome|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302883|NCT00879710|E4|Reported Event|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302884|NCT00879710|E3|Reported Event|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302885|NCT00879710|E2|Reported Event|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302886|NCT00879710|E1|Reported Event|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
302887|NCT00879697|B3|Baseline|Total|Total of all reporting groups
302888|NCT00879697|B2|Baseline|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
302889|NCT00879697|B1|Baseline|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
302890|NCT00879697|P2|Participant Flow|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
302891|NCT00879697|P1|Participant Flow|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
302892|NCT00879697|O2|Outcome|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
302893|NCT00879697|O1|Outcome|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
302894|NCT00879697|E2|Reported Event|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
302895|NCT00879697|E1|Reported Event|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
302896|NCT00879684|B1|Baseline|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle.
302897|NCT00879684|P7|Participant Flow|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
302898|NCT00879684|P6|Participant Flow|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302899|NCT00879684|P5|Participant Flow|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302900|NCT00879684|P4|Participant Flow|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302901|NCT00879684|P3|Participant Flow|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302902|NCT00879684|P2|Participant Flow|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302903|NCT00879684|P1|Participant Flow|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302939|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302904|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
302905|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302906|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302907|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302908|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302909|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302910|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302911|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
302912|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
302913|NCT00879684|O1|Outcome|CVX-060 (Stage 1)|All participants who received 0.3, 1, 3, 6, 12, 15 mg/kg intravenous infusion once-weekly in Stage 1. Participants who discontinued treatment at any time were followed for 6 weeks to assess toxicity, pharmacokinetics (elimination half-life), and immunogenicity.
302914|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302915|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302916|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302917|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302918|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302919|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302920|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302921|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302922|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302923|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302924|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302925|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302926|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302927|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302928|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302929|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302930|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302931|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302932|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302933|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302934|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302935|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302936|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302937|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302938|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302940|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302941|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302942|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302943|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302944|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
302945|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302946|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302947|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302948|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302949|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302950|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
302951|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302952|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302953|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302954|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302955|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302956|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302957|NCT00879684|E7|Reported Event|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
302958|NCT00879684|E6|Reported Event|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302959|NCT00879684|E5|Reported Event|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302960|NCT00879684|E4|Reported Event|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302961|NCT00879684|E3|Reported Event|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302962|NCT00879684|E2|Reported Event|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302963|NCT00879684|E1|Reported Event|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
302964|NCT00879645|B5|Baseline|Total|Total of all reporting groups
302965|NCT00879645|B4|Baseline|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
302966|NCT00879645|B3|Baseline|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302967|NCT00879645|B2|Baseline|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302968|NCT00879645|B1|Baseline|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302969|NCT00879645|P4|Participant Flow|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
302970|NCT00879645|P3|Participant Flow|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302971|NCT00879645|P2|Participant Flow|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302972|NCT00879645|P1|Participant Flow|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302973|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
302974|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302975|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302976|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302977|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
316930|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
302978|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302979|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302980|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302981|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
302982|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302983|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302984|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302985|NCT00879645|E4|Reported Event|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
302986|NCT00879645|E3|Reported Event|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
302987|NCT00879645|E2|Reported Event|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
302988|NCT00879645|E1|Reported Event|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
302989|NCT00879619|B1|Baseline|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302990|NCT00879619|P1|Participant Flow|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302991|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302992|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302993|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302994|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302995|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302996|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302997|NCT00879619|E1|Reported Event|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
302998|NCT00879411|B1|Baseline|Telmisartan, Hydrochlorothiazide|
302999|NCT00879411|P1|Participant Flow|Telmisartan, Hydrochlorothiazide|
303000|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
303001|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
303002|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
303003|NCT00879411|E1|Reported Event|Telmisartan, Hydrochlorothiazide|
303004|NCT00879398|B1|Baseline|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303547|NCT00877799|E2|Reported Event|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)
303005|NCT00879398|P1|Participant Flow|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303006|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303007|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303008|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303009|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303010|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303011|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303012|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303013|NCT00879398|E1|Reported Event|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
303014|NCT00879333|B3|Baseline|Total|Total of all reporting groups
303015|NCT00879333|B2|Baseline|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303016|NCT00879333|B1|Baseline|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303017|NCT00879333|P2|Participant Flow|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303018|NCT00879333|P1|Participant Flow|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303019|NCT00879333|O2|Outcome|Everolimus 5mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 5 mg tablet of everolimus once daily. One of the 11 patients on the 5 mg arm, only had a pre-dose evaluable sample.
303020|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303021|NCT00879333|O2|Outcome|Everolimus 5 mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 1 5 mg tablet of everolimus once daily. Two of the 18 patients on the 5 mg arm, only had pre-dose evaluable samples.
303022|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303023|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303024|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303025|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303026|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303081|NCT00878969|P1|Participant Flow|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
303027|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303028|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303029|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303030|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303031|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303032|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
303033|NCT00879333|E2|Reported Event|Placebo|Placebo
303034|NCT00879333|E1|Reported Event|Everolimus 10mg / Daily|Everolimus 10mg / daily
303035|NCT00879255|B3|Baseline|Total|Total of all reporting groups
303036|NCT00879255|B2|Baseline|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303037|NCT00879255|B1|Baseline|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303038|NCT00879255|P2|Participant Flow|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303039|NCT00879255|P1|Participant Flow|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303040|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303041|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303042|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303043|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303044|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303045|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303046|NCT00879255|E2|Reported Event|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
303047|NCT00879255|E1|Reported Event|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
303048|NCT00879229|B3|Baseline|Total|Total of all reporting groups
303049|NCT00879229|B2|Baseline|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303050|NCT00879229|B1|Baseline|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303051|NCT00879229|P2|Participant Flow|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303052|NCT00879229|P1|Participant Flow|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303053|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303054|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303055|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303056|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303057|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303058|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303059|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303060|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303061|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303062|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303063|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303064|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303065|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303066|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303067|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303068|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303069|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303070|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303071|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303072|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303073|NCT00879229|E2|Reported Event|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
303074|NCT00879229|E1|Reported Event|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
303075|NCT00878969|B4|Baseline|Total|Total of all reporting groups
303076|NCT00878969|B3|Baseline|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
303077|NCT00878969|B2|Baseline|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
303078|NCT00878969|B1|Baseline|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
303079|NCT00878969|P3|Participant Flow|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
303080|NCT00878969|P2|Participant Flow|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
316931|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
303082|NCT00878969|O3|Outcome|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
303083|NCT00878969|O2|Outcome|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
303084|NCT00878969|O1|Outcome|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
303085|NCT00878969|E3|Reported Event|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
303086|NCT00878969|E2|Reported Event|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
303087|NCT00878969|E1|Reported Event|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
303088|NCT00878878|B3|Baseline|Total|Total of all reporting groups
303089|NCT00878878|B2|Baseline|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
303090|NCT00878878|B1|Baseline|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
303091|NCT00878878|P2|Participant Flow|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
303092|NCT00878878|P1|Participant Flow|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
303093|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
303094|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
303095|NCT00878878|O2|Outcome|Elevated Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with elevated pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
303096|NCT00878878|O1|Outcome|Normal Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with normal pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
303097|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
303098|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
303099|NCT00878878|E2|Reported Event|Placebo Control (5% Dextrose) First Followed by the Optison|Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
303100|NCT00878878|E1|Reported Event|Optison Product First Followed by Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
303101|NCT00878826|B4|Baseline|Total|Total of all reporting groups
303102|NCT00878826|B3|Baseline|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303103|NCT00878826|B2|Baseline|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303104|NCT00878826|B1|Baseline|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303105|NCT00878826|P3|Participant Flow|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303106|NCT00878826|P2|Participant Flow|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303107|NCT00878826|P1|Participant Flow|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303108|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303109|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303110|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303111|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303112|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303113|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303114|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303115|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303116|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303117|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303118|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303119|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303120|NCT00878826|E3|Reported Event|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
303121|NCT00878826|E2|Reported Event|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
303122|NCT00878826|E1|Reported Event|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
303123|NCT00878800|B6|Baseline|Total|Total of all reporting groups
303124|NCT00878800|B5|Baseline|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303125|NCT00878800|B4|Baseline|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303126|NCT00878800|B3|Baseline|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
303127|NCT00878800|B2|Baseline|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
303128|NCT00878800|B1|Baseline|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
303129|NCT00878800|P5|Participant Flow|MTD Expansion: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303130|NCT00878800|P4|Participant Flow|Cohort 4: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303131|NCT00878800|P3|Participant Flow|Cohort 3: BelDox IV (800/75)|PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
303132|NCT00878800|P2|Participant Flow|Cohort 2: BelDox IV (600/75)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
303133|NCT00878800|P1|Participant Flow|Cohort 1: BelDox IV (600/50)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
303134|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
303135|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
303136|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
303137|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
303138|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
303139|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
303140|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303141|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303142|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303143|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303144|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303145|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303146|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303147|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303148|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303149|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303150|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303151|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303152|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303153|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
303154|NCT00878800|E5|Reported Event|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303155|NCT00878800|E4|Reported Event|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
303156|NCT00878800|E3|Reported Event|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
303157|NCT00878800|E2|Reported Event|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
303158|NCT00878800|E1|Reported Event|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
303159|NCT00878722|B9|Baseline|Total|Total of all reporting groups
303160|NCT00878722|B8|Baseline|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303161|NCT00878722|B7|Baseline|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303162|NCT00878722|B6|Baseline|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303163|NCT00878722|B5|Baseline|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303164|NCT00878722|B4|Baseline|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303165|NCT00878722|B3|Baseline|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303166|NCT00878722|B2|Baseline|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303167|NCT00878722|B1|Baseline|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303168|NCT00878722|P8|Participant Flow|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303248|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303169|NCT00878722|P7|Participant Flow|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303170|NCT00878722|P6|Participant Flow|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303171|NCT00878722|P5|Participant Flow|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303172|NCT00878722|P4|Participant Flow|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303173|NCT00878722|P3|Participant Flow|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303174|NCT00878722|P2|Participant Flow|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303175|NCT00878722|P1|Participant Flow|Arm A, Step 1|PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303176|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
303177|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
303178|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
303179|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
303180|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
303181|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
303182|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
303183|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
303184|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
303185|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303186|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303187|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303188|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303189|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303190|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303191|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303192|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303193|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303194|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303195|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303196|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303197|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303198|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303199|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303200|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303201|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303202|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303203|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303204|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303205|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303206|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303207|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303208|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303209|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303210|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303211|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303212|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303213|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303214|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303215|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303216|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303217|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303218|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303219|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303220|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303221|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303222|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303223|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303224|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303225|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303226|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303227|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303228|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303229|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303230|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303231|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303232|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303233|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303234|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303235|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303236|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303237|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303238|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303239|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303240|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303241|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303242|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303243|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303244|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303245|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303246|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303247|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303888|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303249|NCT00878722|E8|Reported Event|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303250|NCT00878722|E7|Reported Event|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303251|NCT00878722|E6|Reported Event|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
303252|NCT00878722|E5|Reported Event|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
303253|NCT00878722|E4|Reported Event|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
303254|NCT00878722|E3|Reported Event|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
303255|NCT00878722|E2|Reported Event|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
303256|NCT00878722|E1|Reported Event|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
303257|NCT00878605|B5|Baseline|Total|Total of all reporting groups
303258|NCT00878605|B4|Baseline|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303259|NCT00878605|B3|Baseline|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303260|NCT00878605|B2|Baseline|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303261|NCT00878605|B1|Baseline|Placebo|"Placebo control~Placebo: Placebo control"
303262|NCT00878605|P4|Participant Flow|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks."
303263|NCT00878605|P3|Participant Flow|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks."
303264|NCT00878605|P2|Participant Flow|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks."
303265|NCT00878605|P1|Participant Flow|Arm 1|"Placebo control~Placebo: Placebo control~Participants received placebo tablet orally daily for 12 weeks."
303266|NCT00878605|O4|Outcome|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303267|NCT00878605|O3|Outcome|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303268|NCT00878605|O2|Outcome|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303269|NCT00878605|O1|Outcome|Placebo|"Placebo control~Placebo: Placebo control"
303270|NCT00878605|E4|Reported Event|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303271|NCT00878605|E3|Reported Event|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303272|NCT00878605|E2|Reported Event|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
303273|NCT00878605|E1|Reported Event|Arm 1|"Placebo control~Placebo: Placebo control"
303274|NCT00878553|B5|Baseline|Total|Total of all reporting groups
303275|NCT00878553|B4|Baseline|Sequence 4|15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
303276|NCT00878553|B3|Baseline|Sequence 3|20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
303277|NCT00878553|B2|Baseline|Sequence 2|Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
303278|NCT00878553|B1|Baseline|Sequence 1|10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
303279|NCT00878553|P5|Participant Flow|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303280|NCT00878553|P4|Participant Flow|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303281|NCT00878553|P3|Participant Flow|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303282|NCT00878553|P2|Participant Flow|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
303363|NCT00878228|P2|Participant Flow|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303283|NCT00878553|P1|Participant Flow|Baseline: All Randomized Patients|"The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.~This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two double-dummy tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design."
303284|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303285|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303286|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303287|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303288|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303289|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303290|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303291|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303292|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303293|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303294|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303295|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303296|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303297|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303298|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303299|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303300|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303301|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
303302|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303303|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303304|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10 mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303305|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303306|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303307|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303308|NCT00878553|O2|Outcome|10 mg SKP=1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303309|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303310|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303311|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303312|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303364|NCT00878228|P1|Participant Flow|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303313|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303314|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303315|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303316|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303317|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303318|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303319|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303320|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303321|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303322|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303323|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303324|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303325|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303326|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303327|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303328|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303329|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303330|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303331|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303332|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303333|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
303334|NCT00878553|E4|Reported Event|20mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
303335|NCT00878553|E3|Reported Event|15mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
303336|NCT00878553|E2|Reported Event|10 mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
303337|NCT00878553|E1|Reported Event|Placebo|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
303338|NCT00878501|B4|Baseline|Total|Total of all reporting groups
303339|NCT00878501|B3|Baseline|Placebo Control|Placebo bid for 4 weeks
303340|NCT00878501|B2|Baseline|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303341|NCT00878501|B1|Baseline|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303342|NCT00878501|P3|Participant Flow|Placebo Control|Placebo bid for 4 weeks
303343|NCT00878501|P2|Participant Flow|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303344|NCT00878501|P1|Participant Flow|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303345|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
303346|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303347|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303348|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
303349|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303350|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303351|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
303352|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303353|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303354|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
303355|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303356|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303357|NCT00878501|E3|Reported Event|Placebo Control|Placebo bid for 4 weeks
303358|NCT00878501|E2|Reported Event|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
303359|NCT00878501|E1|Reported Event|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
303360|NCT00878228|B3|Baseline|Total|Total of all reporting groups
303361|NCT00878228|B2|Baseline|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303362|NCT00878228|B1|Baseline|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303365|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303366|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303367|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303368|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303369|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303370|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303371|NCT00878228|E2|Reported Event|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
303372|NCT00878228|E1|Reported Event|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
303373|NCT00877929|B3|Baseline|Total|Total of all reporting groups
303374|NCT00877929|B2|Baseline|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303375|NCT00877929|B1|Baseline|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303376|NCT00877929|P2|Participant Flow|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303377|NCT00877929|P1|Participant Flow|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303378|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303379|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303380|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303381|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303382|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303383|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303384|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303385|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303386|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303387|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303388|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303389|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303390|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303391|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303392|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303393|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303394|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303395|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303396|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303397|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303398|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303399|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303400|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303401|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303545|NCT00877799|E4|Reported Event|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
303402|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303403|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303404|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303405|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303406|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303407|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303408|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303409|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303410|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303411|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303412|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303413|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303414|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303415|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303416|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303417|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303418|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303419|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303420|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303421|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303422|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303423|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303424|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303425|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303426|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303427|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303428|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303429|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303430|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303431|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303432|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303433|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303434|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303435|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303436|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303437|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303438|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303439|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303440|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303441|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303442|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303443|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303444|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303445|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303446|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303447|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303448|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303449|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303450|NCT00877929|O2|Outcome|Amlodipine 5 mg|
303451|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
303452|NCT00877929|O2|Outcome|Amlodipine 5 mg|
303453|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
303454|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303455|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303456|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303457|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303458|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303459|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303460|NCT00877929|E2|Reported Event|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
303461|NCT00877929|E1|Reported Event|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
303462|NCT00877890|B3|Baseline|Total|Total of all reporting groups
303463|NCT00877890|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303464|NCT00877890|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303465|NCT00877890|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303466|NCT00877890|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303467|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
303468|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
303469|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
303470|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
303471|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
303472|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
303473|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
303474|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
303475|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303476|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303546|NCT00877799|E3|Reported Event|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)
303477|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303478|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303479|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303480|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303481|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303482|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303483|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303484|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303485|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303486|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303487|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303488|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303489|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303490|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303491|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303492|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303493|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303494|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303495|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303496|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303497|NCT00877890|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
303498|NCT00877890|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
303499|NCT00877877|B1|Baseline|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303500|NCT00877877|P1|Participant Flow|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303501|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303502|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303503|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303504|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303505|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303506|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303507|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303508|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303509|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303510|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303511|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303512|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303513|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303514|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303515|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303516|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303517|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303518|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
303519|NCT00877877|E6|Reported Event|Cervarix Group From Month 108 to Month 120|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
303520|NCT00877877|E5|Reported Event|Cervarix Group From Month 96 to Month 108|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
303521|NCT00877877|E4|Reported Event|Cervarix Group From Month 84 to Month 96|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
303522|NCT00877877|E3|Reported Event|Cervarix Group From Month 72 to Month 84|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
303523|NCT00877877|E2|Reported Event|Cervarix Group From Month 60 Until Month 72|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
303524|NCT00877877|E1|Reported Event|Cervarix Group From Month 48 Until Month 60|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
303525|NCT00877799|B6|Baseline|Total|Total of all reporting groups
303526|NCT00877799|B5|Baseline|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)
303527|NCT00877799|B4|Baseline|Cohort 2: Placebo|Matched placebo administered within 3 hours post-surgery (Day 0)
303528|NCT00877799|B3|Baseline|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
303529|NCT00877799|B2|Baseline|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
303530|NCT00877799|B1|Baseline|Cohort 1: Placebo|Matched placebo administered 24 hours post-surgery (Day 1)
303531|NCT00877799|P5|Participant Flow|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
303532|NCT00877799|P4|Participant Flow|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
303533|NCT00877799|P3|Participant Flow|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
303534|NCT00877799|P2|Participant Flow|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
303535|NCT00877799|P1|Participant Flow|Cohort 1: Placebo|Matched Placebo administered 24 hours post-surgery (Day 1)
303536|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
303537|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
303538|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
303539|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
303540|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
303541|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
303542|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
303543|NCT00877799|O1|Outcome|Cohort 2: Placebo|Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
303544|NCT00877799|E5|Reported Event|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
303548|NCT00877799|E1|Reported Event|Cohort 1: Placebo|Matched placebo administered 24 hours after surgery (Day 1)
303549|NCT00877773|B1|Baseline|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
303550|NCT00877773|P1|Participant Flow|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
303551|NCT00877773|O1|Outcome|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
303552|NCT00877773|E1|Reported Event|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
303553|NCT00877604|B3|Baseline|Total|Total of all reporting groups
303554|NCT00877604|B2|Baseline|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule"
303555|NCT00877604|B1|Baseline|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
303556|NCT00877604|P2|Participant Flow|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
303557|NCT00877604|P1|Participant Flow|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
303558|NCT00877604|O2|Outcome|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
303559|NCT00877604|O1|Outcome|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
303560|NCT00877604|E2|Reported Event|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
303561|NCT00877604|E1|Reported Event|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
303562|NCT00877487|B1|Baseline|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303563|NCT00877487|P2|Participant Flow|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
303564|NCT00877487|P1|Participant Flow|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303565|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
303566|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303567|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
303568|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303569|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
303570|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303571|NCT00877487|E2|Reported Event|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
303572|NCT00877487|E1|Reported Event|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
303573|NCT00877448|B8|Baseline|Total|Total of all reporting groups
303574|NCT00877448|B7|Baseline|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
303575|NCT00877448|B6|Baseline|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
303576|NCT00877448|B5|Baseline|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
303577|NCT00877448|B4|Baseline|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
303578|NCT00877448|B3|Baseline|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
303579|NCT00877448|B2|Baseline|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
303580|NCT00877448|B1|Baseline|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
303581|NCT00877448|P7|Participant Flow|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
303582|NCT00877448|P6|Participant Flow|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
303583|NCT00877448|P5|Participant Flow|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
303584|NCT00877448|P4|Participant Flow|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
303585|NCT00877448|P3|Participant Flow|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
303586|NCT00877448|P2|Participant Flow|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
303587|NCT00877448|P1|Participant Flow|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
303588|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
303589|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
303590|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
303591|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
303592|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
303593|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
303594|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
303595|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
303596|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
303597|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
303598|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
303599|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
303600|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
303601|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
303602|NCT00877448|E7|Reported Event|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
303603|NCT00877448|E6|Reported Event|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
303604|NCT00877448|E5|Reported Event|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
303605|NCT00877448|E4|Reported Event|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
303606|NCT00877448|E3|Reported Event|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
303607|NCT00877448|E2|Reported Event|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
303608|NCT00877448|E1|Reported Event|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
303609|NCT00877383|B3|Baseline|Total|Total of all reporting groups
303610|NCT00877383|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303611|NCT00877383|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303612|NCT00877383|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303613|NCT00877383|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303614|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303615|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303616|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303617|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303652|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
303653|NCT00875017|E4|Reported Event|Fasting|
303654|NCT00875017|E3|Reported Event|Meal Only|
303655|NCT00875017|E2|Reported Event|Sevelamer Carbonate|
303618|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303619|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303620|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303621|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303622|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303623|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303624|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303625|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303626|NCT00877383|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303627|NCT00877383|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
303628|NCT00877370|B1|Baseline|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
303629|NCT00877370|P1|Participant Flow|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
303630|NCT00877370|O1|Outcome|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
303631|NCT00877370|E1|Reported Event|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
303632|NCT00875017|B7|Baseline|Total|Total of all reporting groups
303633|NCT00875017|B6|Baseline|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303634|NCT00875017|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
303635|NCT00875017|B4|Baseline|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303636|NCT00875017|B3|Baseline|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303637|NCT00875017|B2|Baseline|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303638|NCT00875017|B1|Baseline|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
303639|NCT00875017|P6|Participant Flow|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303640|NCT00875017|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
303641|NCT00875017|P4|Participant Flow|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303642|NCT00875017|P3|Participant Flow|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303643|NCT00875017|P2|Participant Flow|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
303644|NCT00875017|P1|Participant Flow|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
303645|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of calcium is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of calcium is measured.
303646|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
303647|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
303648|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
303649|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
303650|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured.
303651|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
303656|NCT00875017|E1|Reported Event|Lanthanum Carbonate|
303712|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303657|NCT00877071|B1|Baseline|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303658|NCT00877071|P1|Participant Flow|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303659|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303660|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303661|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303662|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303663|NCT00877071|E1|Reported Event|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
303664|NCT00877058|B4|Baseline|Total|Total of all reporting groups
303665|NCT00877058|B3|Baseline|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303666|NCT00877058|B2|Baseline|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
303667|NCT00877058|B1|Baseline|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303668|NCT00877058|P3|Participant Flow|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303669|NCT00877058|P2|Participant Flow|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
303670|NCT00877058|P1|Participant Flow|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303671|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303672|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
303673|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303674|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303675|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
303676|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303677|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303707|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303708|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303709|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303710|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303711|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303678|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
303679|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303680|NCT00877058|E3|Reported Event|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
303681|NCT00877058|E2|Reported Event|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
303682|NCT00877058|E1|Reported Event|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
303683|NCT00877032|B8|Baseline|Total|Total of all reporting groups
303684|NCT00877032|B7|Baseline|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303685|NCT00877032|B6|Baseline|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303686|NCT00877032|B5|Baseline|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303687|NCT00877032|B4|Baseline|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303688|NCT00877032|B3|Baseline|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303689|NCT00877032|B2|Baseline|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303690|NCT00877032|B1|Baseline|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303691|NCT00877032|P7|Participant Flow|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303692|NCT00877032|P6|Participant Flow|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303693|NCT00877032|P5|Participant Flow|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303694|NCT00877032|P4|Participant Flow|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303695|NCT00877032|P3|Participant Flow|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303696|NCT00877032|P2|Participant Flow|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303697|NCT00877032|P1|Participant Flow|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303698|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303699|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303700|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303701|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303702|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303703|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303704|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303705|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303706|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303713|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303714|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303715|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303716|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303717|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303718|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303719|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303720|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303721|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303722|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303723|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303724|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303725|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303726|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303727|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303728|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303729|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303730|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303731|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303732|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303733|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303734|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303735|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303736|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303737|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303738|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303739|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303740|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303741|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303742|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303743|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303744|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303745|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303746|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303747|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303748|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303749|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303750|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303751|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303752|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303753|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303754|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303755|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303756|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303757|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303758|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
316932|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
303759|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303760|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303761|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303762|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303763|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303764|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303765|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303766|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303767|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303768|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303769|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303770|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303771|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303772|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303773|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303774|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303775|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303776|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303777|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303778|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303779|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303780|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303781|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303782|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303783|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303784|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303785|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303786|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303787|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303788|NCT00877032|E7|Reported Event|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
303789|NCT00877032|E6|Reported Event|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
303790|NCT00877032|E5|Reported Event|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
303791|NCT00877032|E4|Reported Event|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
303792|NCT00877032|E3|Reported Event|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
303793|NCT00877032|E2|Reported Event|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
303794|NCT00877032|E1|Reported Event|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
303795|NCT00877006|B3|Baseline|Total|Total of all reporting groups
303796|NCT00877006|B2|Baseline|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303797|NCT00877006|B1|Baseline|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303798|NCT00877006|P2|Participant Flow|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303852|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
304370|NCT00875420|E4|Reported Event|RAD1901 100 mg|Oral once a day for 28 days
303799|NCT00877006|P1|Participant Flow|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303800|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303801|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303802|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303803|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303804|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303805|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303806|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.~R-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1."
303807|NCT00877006|O1|Outcome|Bendamustine/Rituximab|bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1
303808|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303809|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303810|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303811|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303812|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303813|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303814|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303815|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303816|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303817|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303818|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303819|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303820|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303821|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303822|NCT00877006|E2|Reported Event|R-CHOP/CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
303823|NCT00877006|E1|Reported Event|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
303824|NCT00876928|B3|Baseline|Total|Total of all reporting groups
303825|NCT00876928|B2|Baseline|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
303826|NCT00876928|B1|Baseline|Placebo|Subjects with low vitamin D levels and pre-diabetes
303827|NCT00876928|P2|Participant Flow|Vitamin D|"Subjects with low vitamin D levels and pre-diabetes~Liquid vitamin D3 dissolved in medium chain triglyceride once per week"
303828|NCT00876928|P1|Participant Flow|Placebo|"Subjects with low vitamin D levels and pre-diabetes~Medium chain triglyceride given once per week"
303829|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
303830|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
303831|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
303832|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
303833|NCT00876928|E2|Reported Event|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
303834|NCT00876928|E1|Reported Event|Placebo|Subjects with low vitamin D levels and pre-diabetes
303835|NCT00876915|B4|Baseline|Total|Total of all reporting groups
303836|NCT00876915|B3|Baseline|Low Risk|Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
303837|NCT00876915|B2|Baseline|High Risk Randomized to No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
303838|NCT00876915|B1|Baseline|High Risk Randomized to Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
303839|NCT00876915|P3|Participant Flow|Low or Medium Risk Group|Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
303840|NCT00876915|P2|Participant Flow|High Risk No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
303841|NCT00876915|P1|Participant Flow|High Risk Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
303842|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
303843|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
303844|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
303845|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
303846|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
303847|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
303848|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
303849|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
303850|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
303851|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
316933|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
303853|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
303854|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
303855|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
303856|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
303857|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
303858|NCT00876915|E2|Reported Event|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
303859|NCT00876915|E1|Reported Event|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
303860|NCT00876733|B5|Baseline|Total|Total of all reporting groups
303861|NCT00876733|B4|Baseline|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303862|NCT00876733|B3|Baseline|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303863|NCT00876733|B2|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303864|NCT00876733|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303865|NCT00876733|P4|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303866|NCT00876733|P3|Participant Flow|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303867|NCT00876733|P2|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303868|NCT00876733|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303869|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303870|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303871|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303872|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303873|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303874|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303875|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303876|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303877|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303878|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303879|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303880|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303881|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303882|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303883|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303884|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303885|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303886|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303887|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303889|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303890|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303891|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303892|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303893|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303894|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303895|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303896|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303897|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303898|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303899|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303900|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303901|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303902|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303903|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303904|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303905|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303906|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303907|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303908|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303909|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303910|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303911|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303912|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303913|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303914|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303915|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303916|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303917|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303918|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303919|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303920|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303921|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303922|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303923|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303924|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303925|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303926|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303927|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303928|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303929|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303930|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303931|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303932|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303933|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303934|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303935|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303936|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303937|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303938|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303939|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303940|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303941|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303942|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303943|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303944|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303945|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303946|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303947|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303948|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303949|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303950|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303951|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303952|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303953|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303954|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303955|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303956|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303957|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303958|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303959|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303960|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303961|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303962|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303963|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303964|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303965|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303966|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303967|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303968|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303969|NCT00876733|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
303970|NCT00876733|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
303971|NCT00876733|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
303972|NCT00876733|E1|Reported Event|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
303973|NCT00876694|B3|Baseline|Total|Total of all reporting groups
303974|NCT00876694|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303975|NCT00876694|B1|Baseline|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303976|NCT00876694|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303977|NCT00876694|P1|Participant Flow|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303978|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303979|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303980|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303981|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303982|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303983|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303984|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303985|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303986|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303987|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303988|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303989|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303990|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303991|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303992|NCT00876694|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303993|NCT00876694|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
303994|NCT00876460|B9|Baseline|Total|Total of all reporting groups
303995|NCT00876460|B8|Baseline|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
303996|NCT00876460|B7|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304093|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
303997|NCT00876460|B6|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
303998|NCT00876460|B5|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
303999|NCT00876460|B4|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304000|NCT00876460|B3|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304001|NCT00876460|B2|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304002|NCT00876460|B1|Baseline|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304003|NCT00876460|P8|Participant Flow|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304004|NCT00876460|P7|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304005|NCT00876460|P6|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304006|NCT00876460|P5|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304007|NCT00876460|P4|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304008|NCT00876460|P3|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304009|NCT00876460|P2|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304010|NCT00876460|P1|Participant Flow|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304011|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
304012|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
304013|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
304014|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
304015|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
304016|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
304017|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
304018|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
304019|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
304020|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
304021|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
304022|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
304023|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
304024|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
304025|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
304026|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
304094|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304095|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304027|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304028|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304029|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304030|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304031|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304032|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304033|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304034|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304035|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304036|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304037|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304038|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304039|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304040|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304041|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304042|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304043|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304044|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304045|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304046|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304047|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304048|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304049|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304050|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304051|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304052|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304053|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304054|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304055|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304056|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304057|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304058|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304059|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304060|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304061|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304062|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304063|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304064|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304065|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304096|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304371|NCT00875420|E3|Reported Event|RAD1901 50 mg|Oral once a day for 28 days
304066|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304067|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304068|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304069|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304070|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304071|NCT00876460|E8|Reported Event|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304072|NCT00876460|E7|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304073|NCT00876460|E6|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304074|NCT00876460|E5|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304075|NCT00876460|E4|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304076|NCT00876460|E3|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304077|NCT00876460|E2|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304078|NCT00876460|E1|Reported Event|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
304079|NCT00876447|B3|Baseline|Total|Total of all reporting groups
304080|NCT00876447|B2|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304081|NCT00876447|B1|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304082|NCT00876447|P2|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304083|NCT00876447|P1|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304084|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304085|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304086|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304087|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304088|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304089|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304090|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304091|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304092|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304372|NCT00875420|E2|Reported Event|RAD1901 25 mg|Oral once a day for 28 days
304097|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304098|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304099|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304100|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304101|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304102|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304103|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304104|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304105|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304106|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304107|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304108|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304109|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304110|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304111|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304112|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304113|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
304114|NCT00876447|E26|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 13|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304115|NCT00876447|E25|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 13|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304116|NCT00876447|E24|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 12|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304117|NCT00876447|E23|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 12|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304118|NCT00876447|E22|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 11|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304119|NCT00876447|E21|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 11|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304120|NCT00876447|E20|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 10|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304121|NCT00876447|E19|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 10|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304122|NCT00876447|E18|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 9|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304123|NCT00876447|E17|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 9|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304124|NCT00876447|E16|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 8|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304125|NCT00876447|E15|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 8|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304126|NCT00876447|E14|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 7|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304127|NCT00876447|E13|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 7|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304128|NCT00876447|E12|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 6|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304129|NCT00876447|E11|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 6|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304130|NCT00876447|E10|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 5|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304131|NCT00876447|E9|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 5|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304132|NCT00876447|E8|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 4|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304133|NCT00876447|E7|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 4|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304134|NCT00876447|E6|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 3|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304135|NCT00876447|E5|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 3|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304136|NCT00876447|E4|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 2|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304137|NCT00876447|E3|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 2|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304373|NCT00875420|E1|Reported Event|RAD1901 10 mg|Oral once a day for 28 days
304138|NCT00876447|E2|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 1|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
304139|NCT00876447|E1|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 1|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
304140|NCT00876343|B4|Baseline|Total|Total of all reporting groups
304141|NCT00876343|B3|Baseline|Placebo Group|Placebo were administered orally once daily
304142|NCT00876343|B2|Baseline|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304143|NCT00876343|B1|Baseline|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304144|NCT00876343|P3|Participant Flow|Placebo Group|Placebo were administered orally once daily
304145|NCT00876343|P2|Participant Flow|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304146|NCT00876343|P1|Participant Flow|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304147|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
304148|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304149|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304150|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
304151|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304152|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304153|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
304154|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304155|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304156|NCT00876343|E3|Reported Event|Placebo Group|Placebo were administered orally once daily
304157|NCT00876343|E2|Reported Event|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
304158|NCT00876343|E1|Reported Event|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
304159|NCT00876265|B1|Baseline|Overall Study|
304160|NCT00876265|P1|Participant Flow|Overall Study|
304161|NCT00876265|O2|Outcome|Zyplast|Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
304162|NCT00876265|O1|Outcome|Belotero|Belotero was injected into the left or right nasolabial fold using a randomization schedule.
304163|NCT00876265|E2|Reported Event|Zyplast|
304164|NCT00876265|E1|Reported Event|Belotero|
304165|NCT00875979|B3|Baseline|Total|Total of all reporting groups
304166|NCT00875979|B2|Baseline|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304167|NCT00875979|B1|Baseline|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304168|NCT00875979|P2|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304169|NCT00875979|P1|Participant Flow|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304170|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304171|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304172|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304374|NCT00875394|B4|Baseline|Total|Total of all reporting groups
304173|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304174|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304175|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304176|NCT00875979|E2|Reported Event|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304177|NCT00875979|E1|Reported Event|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
304178|NCT00875836|B3|Baseline|Total|Total of all reporting groups
304179|NCT00875836|B2|Baseline|Placebo|Placebo: 30 mg capsules twice daily
304180|NCT00875836|B1|Baseline|Buspirone|Buspirone: 30 mg capsules twice daily
304181|NCT00875836|P2|Participant Flow|Placebo|Placebo: Flexible dose up to 60mg/day
304182|NCT00875836|P1|Participant Flow|Buspirone|Buspirone: Flexible dose up to 60 mg/day
304183|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
304184|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
304185|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
304186|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
304187|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
304188|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
304189|NCT00875836|E2|Reported Event|Placebo|Placebo: Flexible dose up to 60mg/day
304190|NCT00875836|E1|Reported Event|Buspirone|Buspirone: Flexible dose up to 60 mg/day
304191|NCT00875810|B1|Baseline|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304192|NCT00875810|P1|Participant Flow|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304193|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304194|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304195|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304196|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304197|NCT00875810|E1|Reported Event|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
304198|NCT00875797|B3|Baseline|Total|Total of all reporting groups
304199|NCT00875797|B2|Baseline|Enteral Glutamine|enteral glutamine supplementation
304200|NCT00875797|B1|Baseline|Parenteral Glutamine|parenteral glutamine supplementation
304201|NCT00875797|P2|Participant Flow|Group E|Group E - group with enterally supplemented glutamine
304202|NCT00875797|P1|Participant Flow|Group P|Group P - group with parenterally supplemented glutamine
304203|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|enteral glutamine supplementation
304204|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|parenteral glutamine supplementation
304205|NCT00875797|O2|Outcome|Group - Enteral Glutamine|Group E - group with enterally supplemented glutamine
304206|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
304207|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|Group E - group with enterally supplemented glutamine
304208|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
304209|NCT00875797|E2|Reported Event|Group E|Group E - group with enterally supplemented glutamine
304210|NCT00875797|E1|Reported Event|Group P|Group P - group with parenterally supplemented glutamine
304211|NCT00875706|B4|Baseline|Total|Total of all reporting groups
304212|NCT00875706|B3|Baseline|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304213|NCT00875706|B2|Baseline|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304214|NCT00875706|B1|Baseline|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304215|NCT00875706|P3|Participant Flow|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304216|NCT00875706|P2|Participant Flow|Data Collection - Survey|"Survey data collection tools were piloted to assess feasibility of survey administration and development for use in a long-term care setting. These tools were piloted in sites where the educational intervention was administered.~The survey was a modified version of the Care Coordination Survey which was originally validated in a hospital setting (citation below). The survey pertains to work context factors that shape practice, including staffing and resources, communication and IT, participation in decision-making, relationships with supervisors, professional empowerment, and relational coordination. Modifications were made for use of the survey in a VA Community Living Centers.~Weinberg, D., J. Perloff, D. Cooney-Miner, and E. Glaser, Supporting work and workers: Validation of a hospital work organization survey for professional and paraprofessional workers. 2008."
304217|NCT00875706|P1|Participant Flow|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm.~Educational Intervention: The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia."
304218|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304219|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304220|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304221|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304222|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304223|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304224|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304225|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304226|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304227|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304228|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304229|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304230|NCT00875706|E3|Reported Event|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
304231|NCT00875706|E2|Reported Event|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
304232|NCT00875706|E1|Reported Event|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
304233|NCT00875615|B1|Baseline|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
304291|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304234|NCT00875615|P1|Participant Flow|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
304235|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
304236|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
304237|NCT00875615|E1|Reported Event|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
304238|NCT00875589|B3|Baseline|Total|Total of all reporting groups
304239|NCT00875589|B2|Baseline|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
304240|NCT00875589|B1|Baseline|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
304241|NCT00875589|P2|Participant Flow|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
304242|NCT00875589|P1|Participant Flow|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
304243|NCT00875589|O2|Outcome|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
304244|NCT00875589|O1|Outcome|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
304245|NCT00875589|E2|Reported Event|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
304246|NCT00875589|E1|Reported Event|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
304247|NCT00875563|B1|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
304248|NCT00875563|P1|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
304249|NCT00875563|O1|Outcome|Zenith® Fenestrated AAA Endovascular Graft|
304250|NCT00875563|E1|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
304251|NCT00875550|B3|Baseline|Total|Total of all reporting groups
304252|NCT00875550|B2|Baseline|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304253|NCT00875550|B1|Baseline|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304254|NCT00875550|P2|Participant Flow|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304255|NCT00875550|P1|Participant Flow|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304256|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304257|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304258|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304259|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304260|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304261|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304262|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304263|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304264|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304265|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
304266|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304267|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304268|NCT00875550|E2|Reported Event|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304269|NCT00875550|E1|Reported Event|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
304270|NCT00875485|B3|Baseline|Total|Total of all reporting groups
304271|NCT00875485|B2|Baseline|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304272|NCT00875485|B1|Baseline|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304273|NCT00875485|P2|Participant Flow|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304274|NCT00875485|P1|Participant Flow|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304275|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304276|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304277|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304278|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304279|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304280|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304281|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304282|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304283|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304284|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304285|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304286|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304287|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304288|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304289|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304290|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304292|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304293|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304294|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304295|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304296|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304297|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304298|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304299|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304300|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304301|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304302|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304303|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304304|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304305|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304306|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304307|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304308|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304309|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304310|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304311|NCT00875485|E2|Reported Event|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
304312|NCT00875485|E1|Reported Event|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
304313|NCT00875433|B1|Baseline|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304314|NCT00875433|P1|Participant Flow|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304315|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304316|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304317|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304318|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304319|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304320|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304321|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304322|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304323|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304324|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304325|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304326|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304327|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304328|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304329|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304330|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304331|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304332|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304333|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304334|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304335|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304336|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304337|NCT00875433|E1|Reported Event|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
304338|NCT00875420|B6|Baseline|Total|Total of all reporting groups
304339|NCT00875420|B5|Baseline|Placebo|Oral once a day for 28 days
304340|NCT00875420|B4|Baseline|RAD1901 100 mg|Oral once a day for 28 days
304341|NCT00875420|B3|Baseline|RAD1901 50 mg|Oral once a day for 28 days
304342|NCT00875420|B2|Baseline|RAD1901 25 mg|Oral once a day for 28 days
304343|NCT00875420|B1|Baseline|RAD1901 10 mg|Oral once a day for 28 days
304344|NCT00875420|P5|Participant Flow|Placebo|Oral once a day for 28 days
304345|NCT00875420|P4|Participant Flow|RAD1901 100 mg|Oral once a day for 28 days
304346|NCT00875420|P3|Participant Flow|RAD1901 50 mg|Oral once a day for 28 days
304347|NCT00875420|P2|Participant Flow|RAD1901 25 mg|Oral once a day for 28 days
304348|NCT00875420|P1|Participant Flow|RAD1901 10 mg|Oral once a day for 28 days
304349|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
304350|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
304351|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
304352|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
304353|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
304354|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
304355|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
304356|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
304357|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
304358|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
304359|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
304360|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
304361|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
304362|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
304363|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
304364|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
304365|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
304375|NCT00875394|B3|Baseline|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304376|NCT00875394|B2|Baseline|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304377|NCT00875394|B1|Baseline|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
304378|NCT00875394|P3|Participant Flow|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304379|NCT00875394|P2|Participant Flow|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304380|NCT00875394|P1|Participant Flow|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
304381|NCT00875394|O3|Outcome|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304382|NCT00875394|O2|Outcome|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304383|NCT00875394|O1|Outcome|Sitagliptin + Metformin|Patients administered sitagliptin and metformin.
304384|NCT00875394|E3|Reported Event|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304385|NCT00875394|E2|Reported Event|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
304386|NCT00875394|E1|Reported Event|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
304387|NCT00875329|B1|Baseline|Group 1|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
304388|NCT00875329|P1|Participant Flow|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
304389|NCT00875329|O1|Outcome|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
304390|NCT00875329|E1|Reported Event|Convenience Sample|A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
304391|NCT00875212|B1|Baseline|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
304392|NCT00875212|P1|Participant Flow|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
304393|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a CaGP+Fluoride dentifrice
304394|NCT00875212|O3|Outcome|Fluoride|intrvention of using a 1,500 ppm fluoridated dentifrice
304395|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a CaGP dentifrice
304396|NCT00875212|O1|Outcome|Control|use of a placebo dentifrice (no fluoride and no CaGP). The volunteers were asked to use the placebo dentifrices for more one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
304397|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a dentifrice containing fluoride and calcium glycerophosphate
304398|NCT00875212|O3|Outcome|Fluoride|intervention of using a dentifrice with 1,500 ppm of fluoride
304399|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)
304438|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304439|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
316934|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
304400|NCT00875212|O1|Outcome|Control|intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
304401|NCT00875212|E1|Reported Event|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
304402|NCT00874939|B1|Baseline|All Participants|All enrolled participants
304403|NCT00874939|P1|Participant Flow|All Participants|All enrolled participants
304404|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304405|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304406|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
304407|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304408|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304409|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304410|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
304411|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304412|NCT00874939|E4|Reported Event|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304413|NCT00874939|E3|Reported Event|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304414|NCT00874939|E2|Reported Event|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
304415|NCT00874939|E1|Reported Event|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
304416|NCT00874887|B3|Baseline|Total|Total of all reporting groups
304417|NCT00874887|B2|Baseline|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304418|NCT00874887|B1|Baseline|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304419|NCT00874887|P2|Participant Flow|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304420|NCT00874887|P1|Participant Flow|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304421|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304422|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304423|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304424|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304425|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304426|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304427|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304428|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304429|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304430|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304431|NCT00874887|E2|Reported Event|Zymar®|Gatifloxacin 0.3% ophthalmic solution
304432|NCT00874887|E1|Reported Event|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
304433|NCT00874848|B3|Baseline|Total|Total of all reporting groups
304434|NCT00874848|B2|Baseline|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304435|NCT00874848|B1|Baseline|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304436|NCT00874848|P2|Participant Flow|Control Arm|"Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
304437|NCT00874848|P1|Participant Flow|Imprime PGG Arm|"Imprime PGG® infusion:~4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;~Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
304440|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304441|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304442|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304443|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304444|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304445|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304446|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304447|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304448|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304449|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304450|NCT00874848|E2|Reported Event|Control Arm|Cetuximab + Paclitaxel/Carboplatin
304451|NCT00874848|E1|Reported Event|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
304452|NCT00874822|B1|Baseline|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
304453|NCT00874822|P1|Participant Flow|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
304454|NCT00874822|O1|Outcome|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
304455|NCT00874822|E1|Reported Event|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
304456|NCT00874770|B5|Baseline|Total|Total of all reporting groups
304457|NCT00874770|B4|Baseline|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304458|NCT00874770|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin|Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304459|NCT00874770|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin|Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304460|NCT00874770|B1|Baseline|Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304461|NCT00874770|P4|Participant Flow|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304462|NCT00874770|P3|Participant Flow|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304463|NCT00874770|P2|Participant Flow|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304464|NCT00874770|P1|Participant Flow|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304465|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304466|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304467|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304468|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304469|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
304470|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304471|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304472|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Riibavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304473|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304474|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304475|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304476|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304477|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304478|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304479|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304480|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304481|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304482|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304483|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304484|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304485|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304486|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304487|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304711|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304712|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304488|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Rribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304489|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304490|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304491|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304492|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304493|NCT00874770|E4|Reported Event|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304494|NCT00874770|E3|Reported Event|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304495|NCT00874770|E2|Reported Event|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304496|NCT00874770|E1|Reported Event|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
304497|NCT00874549|B5|Baseline|Total|Total of all reporting groups
304498|NCT00874549|B4|Baseline|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304499|NCT00874549|B3|Baseline|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304500|NCT00874549|B2|Baseline|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304501|NCT00874549|B1|Baseline|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304502|NCT00874549|P4|Participant Flow|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304503|NCT00874549|P3|Participant Flow|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304504|NCT00874549|P2|Participant Flow|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304505|NCT00874549|P1|Participant Flow|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304506|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304507|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304508|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304509|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304510|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
316935|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
304511|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304512|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304513|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304514|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304515|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304516|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304517|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304518|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304519|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304520|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304521|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304522|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304523|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304524|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304525|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304526|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304527|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304528|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304529|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304530|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304531|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304532|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304533|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304534|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304535|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304536|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304537|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304538|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304539|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304540|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304541|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304542|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304543|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304544|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304545|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304546|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304547|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304548|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304549|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304550|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304551|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304552|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304553|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304554|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304555|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304556|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304557|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304558|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304559|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304560|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304561|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304562|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
304563|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
304564|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
304565|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
304566|NCT00874549|E4|Reported Event|Menactra® Day 0 and Day 28|
304567|NCT00874549|E3|Reported Event|Menactra® Day 0 and Day 14|
304568|NCT00874549|E2|Reported Event|Menactra® Day 0 x 2|
304569|NCT00874549|E1|Reported Event|Menomune® Day 0|
304570|NCT00874510|B3|Baseline|Total|Total of all reporting groups
304571|NCT00874510|B2|Baseline|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
304572|NCT00874510|B1|Baseline|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
304573|NCT00874510|P2|Participant Flow|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
304574|NCT00874510|P1|Participant Flow|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
304575|NCT00874510|O2|Outcome|Arm 2 - Mandatory Nap|"In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time~For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time"
304576|NCT00874510|O1|Outcome|Arm 1 - Standard Schedule for Years 1 and Year 2|interns work standard schedule, being on duty for 30 continuous hours
304577|NCT00874510|E2|Reported Event|Arm 2 - Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
304578|NCT00874510|E1|Reported Event|Arm 1 - Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
304579|NCT00874276|B3|Baseline|Total|Total of all reporting groups
304580|NCT00874276|B2|Baseline|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
304581|NCT00874276|B1|Baseline|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
304582|NCT00874276|P2|Participant Flow|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
304583|NCT00874276|P1|Participant Flow|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
304584|NCT00874276|O2|Outcome|At Least One EGT Allele|At least one EGT allele
304585|NCT00874276|O1|Outcome|No EGT Allele|No EGT allele
304586|NCT00874276|O2|Outcome|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
304587|NCT00874276|O1|Outcome|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
304588|NCT00874276|E2|Reported Event|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
304589|NCT00874276|E1|Reported Event|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
304590|NCT00874250|B1|Baseline|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
304591|NCT00874250|P1|Participant Flow|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
304592|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304593|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304594|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304595|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304596|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304597|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304598|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
304599|NCT00874250|E1|Reported Event|CTAG Device Aneurysym Subjects|
304600|NCT00874120|B3|Baseline|Total|Total of all reporting groups
304601|NCT00874120|B2|Baseline|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
304602|NCT00874120|B1|Baseline|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
304603|NCT00874120|P2|Participant Flow|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
304604|NCT00874120|P1|Participant Flow|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
304605|NCT00874120|O2|Outcome|Placebo|Placebo twice daily for 7 days
304606|NCT00874120|O1|Outcome|Phenylephrine|Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
304607|NCT00874120|E2|Reported Event|Placebo|Placebo twice daily for 7 days
304608|NCT00874120|E1|Reported Event|Phenylephrine|Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days
304609|NCT00874094|B1|Baseline|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304610|NCT00874094|P1|Participant Flow|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304611|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304612|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304613|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304614|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304615|NCT00874094|E1|Reported Event|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
304616|NCT00874029|B1|Baseline|Halt Medical Acessa Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient’s uterine fibroids and treat all of her fibroids, and just the fibroids.
304617|NCT00874029|P1|Participant Flow|Halt Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
304618|NCT00874029|O2|Outcome|How Effective Was This Treatment in Eliminating Symptoms|Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
304619|NCT00874029|O1|Outcome|Overall, Satisfaction With Uterine Fibroid Treatment|Patients were asked, overall, how satisfied with their uterine fibroid treatment.
304620|NCT00874029|O1|Outcome|Full Analysis Set - Month 12 Health Status Change|All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
304621|NCT00874029|O2|Outcome|Full Analysis Set - Health Related Quality of Life (HRQL)|All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
304622|NCT00874029|O1|Outcome|Full Analysis Set - Symptom Severity|All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.
304623|NCT00874029|O2|Outcome|Change in Fibroid Volume|Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
304624|NCT00874029|O1|Outcome|Change in Uterine Volume|Uterine volume assessment 12 months post treatment via contrast enhanced MRI
304625|NCT00874029|O1|Outcome|Surgical Reintervention 12 Months Post Treatment|The Per Protocol Set was the primary analysis set for surgical reintervention.
304626|NCT00874029|O2|Outcome|Procedural|Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
304627|NCT00874029|O1|Outcome|Device Related Adverse Events|Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.
304713|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304628|NCT00874029|O1|Outcome|Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment|"Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered evaluable in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits."
304629|NCT00874029|E1|Reported Event|Safety Set|The Safety Set consisted of all subjects treated in the study.
304630|NCT00873912|B3|Baseline|Total|Total of all reporting groups
304631|NCT00873912|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304632|NCT00873912|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304633|NCT00873912|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304634|NCT00873912|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304635|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304636|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304637|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304638|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304639|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304640|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304641|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304642|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304643|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304644|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304645|NCT00873912|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
304646|NCT00873912|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
304647|NCT00873873|B5|Baseline|Total|Total of all reporting groups
304648|NCT00873873|B4|Baseline|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
304649|NCT00873873|B3|Baseline|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
304650|NCT00873873|B2|Baseline|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
304651|NCT00873873|B1|Baseline|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
304652|NCT00873873|P4|Participant Flow|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
304714|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304653|NCT00873873|P3|Participant Flow|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
304654|NCT00873873|P2|Participant Flow|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
304655|NCT00873873|P1|Participant Flow|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
304656|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
304657|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
304658|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
304659|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
304660|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
304661|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
304662|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
304663|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
304664|NCT00873873|E4|Reported Event|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
304665|NCT00873873|E3|Reported Event|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
304666|NCT00873873|E2|Reported Event|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
304667|NCT00873873|E1|Reported Event|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
304668|NCT00873821|B3|Baseline|Total|Total of all reporting groups
304669|NCT00873821|B2|Baseline|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304670|NCT00873821|B1|Baseline|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304671|NCT00873821|P2|Participant Flow|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304672|NCT00873821|P1|Participant Flow|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304673|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304674|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304675|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304676|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304677|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304715|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304678|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304679|NCT00873821|E2|Reported Event|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
304680|NCT00873821|E1|Reported Event|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
304681|NCT00873782|B1|Baseline|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
304682|NCT00873782|P1|Participant Flow|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
304683|NCT00873782|O1|Outcome|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
304684|NCT00873782|E1|Reported Event|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
304685|NCT00873730|B3|Baseline|Total|Total of all reporting groups
304686|NCT00873730|B2|Baseline|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304687|NCT00873730|B1|Baseline|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304688|NCT00873730|P2|Participant Flow|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304689|NCT00873730|P1|Participant Flow|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304690|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304691|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304692|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304693|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304694|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304695|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304696|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304697|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304698|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304699|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304700|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304701|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304702|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304703|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304704|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304705|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304706|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304707|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304708|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304709|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304710|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304716|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304717|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304718|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304719|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304720|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304721|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304722|NCT00873730|E2|Reported Event|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
304723|NCT00873730|E1|Reported Event|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
304724|NCT00873457|B1|Baseline|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304725|NCT00873457|P1|Participant Flow|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304726|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304727|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304728|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304729|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304730|NCT00873457|E1|Reported Event|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
304731|NCT00873327|B1|Baseline|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
304732|NCT00873327|P1|Participant Flow|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation (GA) at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
304733|NCT00873327|O1|Outcome|PK Analysis Cohort - Piperacillin Plasma Clearance|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
304734|NCT00873327|E1|Reported Event|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
304735|NCT00873119|B3|Baseline|Total|Total of all reporting groups
304736|NCT00873119|B2|Baseline|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304737|NCT00873119|B1|Baseline|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304738|NCT00873119|P2|Participant Flow|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304739|NCT00873119|P1|Participant Flow|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304740|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304741|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304742|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304743|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304744|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304745|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304986|NCT00872729|E1|Reported Event|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg;
304987|NCT00872599|B1|Baseline|Study Group|
304746|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304747|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304748|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304749|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304750|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304751|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304752|NCT00873119|E2|Reported Event|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
304753|NCT00873119|E1|Reported Event|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
304754|NCT00873093|B6|Baseline|Total|Total of all reporting groups
304755|NCT00873093|B5|Baseline|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304756|NCT00873093|B4|Baseline|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304757|NCT00873093|B3|Baseline|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304758|NCT00873093|B2|Baseline|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304759|NCT00873093|B1|Baseline|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304760|NCT00873093|P5|Participant Flow|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304761|NCT00873093|P4|Participant Flow|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304762|NCT00873093|P3|Participant Flow|Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304763|NCT00873093|P2|Participant Flow|Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
305058|NCT00872430|B1|Baseline|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
304764|NCT00873093|P1|Participant Flow|Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304765|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304766|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304767|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304768|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304769|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304770|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304771|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304864|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304772|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304773|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304774|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304775|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304776|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304777|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304778|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304788|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304895|NCT00872989|O1|Outcome|Vandetanib|Patients elected to participant in the crossover registration in Vandetanib after progression in single agent docetaxel.
304896|NCT00872989|O1|Outcome|Vandetanib|Vandetanib treated patients
304779|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304780|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304781|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304782|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304783|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304784|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
304785|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304786|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304787|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304842|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304789|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304790|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304791|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304792|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304793|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304794|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304795|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304796|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304797|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304798|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304799|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304800|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
304801|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
304802|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304803|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304804|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304805|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304806|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304807|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304808|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304809|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304810|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304811|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304812|NCT00873093|E5|Reported Event|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304813|NCT00873093|E4|Reported Event|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304814|NCT00873093|E3|Reported Event|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304815|NCT00873093|E2|Reported Event|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304816|NCT00873093|E1|Reported Event|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
304817|NCT00873041|B4|Baseline|Total|Total of all reporting groups
304818|NCT00873041|B3|Baseline|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304819|NCT00873041|B2|Baseline|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304820|NCT00873041|B1|Baseline|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304821|NCT00873041|P3|Participant Flow|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304822|NCT00873041|P2|Participant Flow|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304823|NCT00873041|P1|Participant Flow|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304897|NCT00872989|O3|Outcome|Vandetanib|
304898|NCT00872989|O2|Outcome|Docetaxel + Vandetanib|
304824|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304825|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304826|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304827|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304828|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304829|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304830|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304831|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304832|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304833|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304834|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304835|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304836|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304837|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304838|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304839|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304840|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304841|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304899|NCT00872989|O1|Outcome|Docetaxel|
305143|NCT00871819|O1|Outcome|All Subjects|All enrolled subjects
304843|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304844|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304845|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304846|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304847|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304848|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304849|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304850|NCT00873041|O1|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304851|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304852|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304853|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304854|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304855|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304856|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304857|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304858|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304859|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304860|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304861|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304862|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304863|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304937|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304865|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304866|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304867|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304868|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304869|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304870|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304871|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304872|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
304873|NCT00873041|E3|Reported Event|Placebo/Deferasirox Any Dose|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304874|NCT00873041|E2|Reported Event|Deferasirox 10 mg/kg/Day|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304875|NCT00873041|E1|Reported Event|Deferasirox 5 mg/kg/Day|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
304876|NCT00873015|B5|Baseline|Total|Total of all reporting groups
304877|NCT00873015|B4|Baseline|64 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg
304878|NCT00873015|B3|Baseline|48 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg
304879|NCT00873015|B2|Baseline|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
304880|NCT00873015|B1|Baseline|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg
304881|NCT00873015|P4|Participant Flow|Nitrite 64 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 64 nmol/min/kg
304882|NCT00873015|P3|Participant Flow|Nitrite 48 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 48 nmol/min/kg
304883|NCT00873015|P2|Participant Flow|Nitrite 32 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 32 nmol/min/kg
304884|NCT00873015|P1|Participant Flow|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
304885|NCT00873015|O3|Outcome|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
304886|NCT00873015|O2|Outcome|48 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
304887|NCT00873015|O1|Outcome|64 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
304888|NCT00873015|E2|Reported Event|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
304889|NCT00873015|E1|Reported Event|Nitrite|Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
304890|NCT00872989|B3|Baseline|Total|Total of all reporting groups
304891|NCT00872989|B2|Baseline|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304892|NCT00872989|B1|Baseline|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304893|NCT00872989|P2|Participant Flow|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304894|NCT00872989|P1|Participant Flow|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304938|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
304900|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304901|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304902|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304903|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304904|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304905|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
304906|NCT00872989|E3|Reported Event|Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
304907|NCT00872989|E2|Reported Event|Docetaxel + Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
304908|NCT00872989|E1|Reported Event|Docetaxel|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
304909|NCT00872898|B4|Baseline|Total|Total of all reporting groups
304910|NCT00872898|B3|Baseline|Part Two - Memantine|Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
304911|NCT00872898|B2|Baseline|Part Two - Placebo|Once daily oral administration of placebo for 12 weeks.
304912|NCT00872898|B1|Baseline|Part One - Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
304913|NCT00872898|P2|Participant Flow|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304914|NCT00872898|P1|Participant Flow|Placebo|Once daily, oral administration of placebo for 12 weeks.
304915|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304916|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304917|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304918|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304919|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304920|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304921|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304922|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304923|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304924|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304925|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304926|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304927|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304928|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304929|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304930|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304931|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304932|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304933|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304934|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304935|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304936|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
305255|NCT00871377|P1|Participant Flow|P L H|Placebo, then Low Dose, then High Dose
304939|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304940|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304941|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
304942|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
304943|NCT00872898|O1|Outcome|Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
304944|NCT00872898|E3|Reported Event|Memantine - Part One, Open Label Treatment|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
304945|NCT00872898|E2|Reported Event|Memantine - Part Two, Double-Blind Treatment|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups."
304946|NCT00872898|E1|Reported Event|Placebo - Part Two, Double-Blind Treatment|Once daily oral administration of placebo for 12 weeks
304947|NCT00872833|B1|Baseline|Overall|Both cohorts combined
304948|NCT00872833|P2|Participant Flow|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
304949|NCT00872833|P1|Participant Flow|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
304950|NCT00872833|O4|Outcome|> 28 Days|Subjects with transfusion cycles greater than 28 days
304951|NCT00872833|O3|Outcome|22 - 28 Days|Subjects with transfusion cycles between 22 and 28 days
304952|NCT00872833|O2|Outcome|15 - 21 Days|Subjects with transfusion cycles between 15 and 21 days
304953|NCT00872833|O1|Outcome|<= 14 Days|Subjects with transfusion cycles of 14 days or less
304954|NCT00872833|O2|Outcome|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
304955|NCT00872833|O1|Outcome|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
304956|NCT00872833|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected as part of this observational study.
304957|NCT00872729|B1|Baseline|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg.
304958|NCT00872729|P1|Participant Flow|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg; Single-dose, open-label, nonrandomized, 2-period, crossover study of cysteamine bitartrate delayed-release capsules (RP103) and Cystagon®. Subjects were enrolled sequentially and received Cystagon® first followed by RP103.
304959|NCT00872729|O20|Outcome|RP103 (12 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304960|NCT00872729|O19|Outcome|Cystagon® (12 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304961|NCT00872729|O18|Outcome|RP103 (10 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304962|NCT00872729|O17|Outcome|Cystagon® (10 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304963|NCT00872729|O16|Outcome|RP103 (8 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304964|NCT00872729|O15|Outcome|Cystagon® (8 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304965|NCT00872729|O14|Outcome|RP103 (6 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304966|NCT00872729|O13|Outcome|Cystagon® (6 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304967|NCT00872729|O12|Outcome|RP103 (4 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304968|NCT00872729|O11|Outcome|Cystagon® (4 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304969|NCT00872729|O10|Outcome|RP103 (3 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304970|NCT00872729|O9|Outcome|Cystagon® (3 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304971|NCT00872729|O8|Outcome|RP103 (2.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304972|NCT00872729|O7|Outcome|Cystagon® (2.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304973|NCT00872729|O6|Outcome|RP103 (2 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304974|NCT00872729|O5|Outcome|Cystagon® (2 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304975|NCT00872729|O4|Outcome|RP103 (1 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304976|NCT00872729|O3|Outcome|Cystagon® (1 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304977|NCT00872729|O2|Outcome|RP103 (0.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304978|NCT00872729|O1|Outcome|Cystagon® (0.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304979|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304980|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304981|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304982|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304983|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
304984|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
304985|NCT00872729|E2|Reported Event|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
316936|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
304988|NCT00872599|P2|Participant Flow|Fenofibrate, Then Placebo|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
304989|NCT00872599|P1|Participant Flow|Placebo, Then Fenofibrate|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.
304990|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
304991|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
304992|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
304993|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
304994|NCT00872599|E2|Reported Event|Fenofibrate|
304995|NCT00872599|E1|Reported Event|Placebo|
304996|NCT00872534|B3|Baseline|Total|Total of all reporting groups
304997|NCT00872534|B2|Baseline|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
304998|NCT00872534|B1|Baseline|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
304999|NCT00872534|P2|Participant Flow|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
305000|NCT00872534|P1|Participant Flow|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
305001|NCT00872534|O2|Outcome|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
305002|NCT00872534|O1|Outcome|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
305003|NCT00872534|E2|Reported Event|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
305004|NCT00872534|E1|Reported Event|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
305005|NCT00872521|B4|Baseline|Total|Total of all reporting groups
305006|NCT00872521|B3|Baseline|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305007|NCT00872521|B2|Baseline|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305008|NCT00872521|B1|Baseline|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305009|NCT00872521|P3|Participant Flow|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305010|NCT00872521|P2|Participant Flow|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305011|NCT00872521|P1|Participant Flow|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305012|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
305013|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
305014|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
305015|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
305016|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
305017|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
305018|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
305019|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
305020|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
305021|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
305022|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
305023|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
305024|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
305025|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
305026|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
305027|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
305028|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305029|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305030|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305256|NCT00871377|O3|Outcome|Fish OIl High Dose|Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
305031|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305032|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305033|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305034|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305035|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305036|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305037|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305038|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305039|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305040|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305041|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305042|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305043|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305044|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305045|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305046|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305047|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305048|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305049|NCT00872521|O3|Outcome|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305050|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305051|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305052|NCT00872521|E4|Reported Event|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305053|NCT00872521|E3|Reported Event|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305054|NCT00872521|E2|Reported Event|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305055|NCT00872521|E1|Reported Event|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
305056|NCT00872430|B3|Baseline|Total|Total of all reporting groups
305057|NCT00872430|B2|Baseline|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
305059|NCT00872430|P2|Participant Flow|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
305060|NCT00872430|P1|Participant Flow|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
305061|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
305062|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
305063|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
305064|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
305065|NCT00872339|B4|Baseline|Total|Total of all reporting groups
305066|NCT00872339|B3|Baseline|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
305067|NCT00872339|B2|Baseline|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
305068|NCT00872339|B1|Baseline|Transfusion-dependant|People with transfusion-dependant thalassemia.
305069|NCT00872339|P3|Participant Flow|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
305070|NCT00872339|P2|Participant Flow|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
305071|NCT00872339|P1|Participant Flow|Transfusion-dependant|People with transfusion-dependant thalassemia.
305072|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
305073|NCT00872339|O1|Outcome|All Subjects Combined|Subjects were combined into one group.
305074|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
305075|NCT00872339|O3|Outcome|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
305076|NCT00872339|O2|Outcome|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
305077|NCT00872339|O1|Outcome|Transfusion-dependant|People with transfusion-dependant thalassemia.
305078|NCT00872339|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected for this study.
305079|NCT00872170|B3|Baseline|Total|Total of all reporting groups
305080|NCT00872170|B2|Baseline|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
305081|NCT00872170|B1|Baseline|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305082|NCT00872170|P2|Participant Flow|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
305083|NCT00872170|P1|Participant Flow|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305084|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305085|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305086|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305087|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305088|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305089|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305090|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305144|NCT00871819|E1|Reported Event|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
305145|NCT00871780|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305091|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305092|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305093|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305094|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305095|NCT00872170|E2|Reported Event|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
305096|NCT00872170|E1|Reported Event|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
305097|NCT00872079|B1|Baseline|Genomics|"The specific aims of this research are:~Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)~Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.~Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)~Determine the utility of the computer programs prospectively in the clinical setting."
305098|NCT00872079|P1|Participant Flow|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
305099|NCT00872079|O1|Outcome|Genomics|"Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.~There are 4 Aims in this study.~To collect historical data on warfarin dosing in subjects.~To collect genotype information on up to 300 subjects receiving warfarin anticoagulation.~to develop a computer model incorporating the information from aim 1 and aim 2.~To conduct a randomized clinical trial."
305100|NCT00872079|E1|Reported Event|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
305101|NCT00872001|B3|Baseline|Total|Total of all reporting groups
305102|NCT00872001|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
305103|NCT00872001|B1|Baseline|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
305104|NCT00872001|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
305105|NCT00872001|P1|Participant Flow|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
305106|NCT00872001|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
305107|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
305108|NCT00872001|O2|Outcome|Placebo|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
305109|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).
305110|NCT00872001|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
305111|NCT00872001|E1|Reported Event|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
305146|NCT00871780|P1|Participant Flow|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305147|NCT00871780|O3|Outcome|Natalizumab: Baseline EDSS >= 4.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5
305112|NCT00871975|B1|Baseline|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
305113|NCT00871975|P1|Participant Flow|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
305114|NCT00871975|O1|Outcome|Urodynamics + Tetra NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
305115|NCT00871975|E1|Reported Event|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
305116|NCT00871871|B3|Baseline|Total|Total of all reporting groups
305117|NCT00871871|B2|Baseline|All Part II Participants|Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
305118|NCT00871871|B1|Baseline|All Part I Participants|Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
305119|NCT00871871|P4|Participant Flow|ISMN Placebo First, Then ISMN|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
305120|NCT00871871|P3|Participant Flow|ISMN First, Then ISMN Placebo|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
305121|NCT00871871|P2|Participant Flow|HCTZ Placebo First, Then HCTZ|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
305122|NCT00871871|P1|Participant Flow|HCTZ First, Then HCTZ Placebo|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
305123|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305124|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305125|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305126|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305127|NCT00871871|O2|Outcome|Isosorbide Mononitrate (ISMN) Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
305128|NCT00871871|O1|Outcome|Isosorbide Mononitrate (ISMN)|Part II: Participants on ISMN in either Period 1 or Period 2
305129|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305130|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305131|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305132|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305133|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305134|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305135|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305136|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
305137|NCT00871871|E4|Reported Event|ISMN Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
305138|NCT00871871|E3|Reported Event|ISMN|Part II: Participants on ISMN in either Period 1 or Period 2
305139|NCT00871871|E2|Reported Event|HCTZ Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
305140|NCT00871871|E1|Reported Event|HCTZ|Part I: Participants on HCTZ in either Period 1 or Period 2
305141|NCT00871819|B1|Baseline|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
305142|NCT00871819|P1|Participant Flow|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
305148|NCT00871780|O2|Outcome|Natalizumab: Baseline EDSS 3.0 to 4.0|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS 3.0 to 4.0
305149|NCT00871780|O1|Outcome|Natalizumab: Baseline EDSS 0 to 2.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS of 0 to 2.5
305150|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305151|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305152|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305153|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305154|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305155|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305156|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305157|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305158|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305159|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305160|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305161|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305162|NCT00871780|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
305163|NCT00871728|B1|Baseline|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305164|NCT00871728|P1|Participant Flow|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305165|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305166|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305167|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305168|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305169|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305170|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305171|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305172|NCT00871728|E1|Reported Event|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
305173|NCT00871715|B4|Baseline|Total|Total of all reporting groups
305174|NCT00871715|B3|Baseline|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305175|NCT00871715|B2|Baseline|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305176|NCT00871715|B1|Baseline|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305249|NCT00871377|B1|Baseline|Baseline|The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
305250|NCT00871377|P6|Participant Flow|H P L|High Dose, then Placebo, then Low Dose
305177|NCT00871715|P3|Participant Flow|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305178|NCT00871715|P2|Participant Flow|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305179|NCT00871715|P1|Participant Flow|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305180|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305181|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305182|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305183|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305184|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305185|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305186|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305187|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305251|NCT00871377|P5|Participant Flow|H L P|High Dose, then Low Dose, then Placebo
305252|NCT00871377|P4|Participant Flow|L P H|Low Dose, then Placebo, then High Dose
305253|NCT00871377|P3|Participant Flow|L H P|Low Dose, then High Dose, then Placebo
305188|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305189|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305190|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305191|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305192|NCT00871715|E4|Reported Event|Screened But Not Randomized|Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
305193|NCT00871715|E3|Reported Event|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
305194|NCT00871715|E2|Reported Event|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
305195|NCT00871715|E1|Reported Event|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
305196|NCT00871689|B1|Baseline|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305197|NCT00871689|P1|Participant Flow|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305198|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305199|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305200|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305201|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305202|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305203|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305204|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305205|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305206|NCT00871689|E1|Reported Event|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
305207|NCT00871624|B3|Baseline|Total|Total of all reporting groups
305208|NCT00871624|B2|Baseline|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305209|NCT00871624|B1|Baseline|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305210|NCT00871624|P2|Participant Flow|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305211|NCT00871624|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305212|NCT00871624|O2|Outcome|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305213|NCT00871624|O1|Outcome|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305214|NCT00871624|E2|Reported Event|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305215|NCT00871624|E1|Reported Event|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
305216|NCT00871494|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305217|NCT00871494|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305218|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305219|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305220|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305221|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305222|NCT00871494|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
305223|NCT00871429|B1|Baseline|Cancer Patients Using Lindi Skin Products|
305224|NCT00871429|P1|Participant Flow|Lindi Skin Participant Flow|
305225|NCT00871429|O3|Outcome|Lindi Skin Face Serum (Product B)|
305226|NCT00871429|O2|Outcome|Lindi Skin Face Wash (Product C)|
305227|NCT00871429|O1|Outcome|Lindi Skin Soothing Balm (Product A)|
305228|NCT00871429|E3|Reported Event|Lindi Skin Face Serum (Product B)|
305229|NCT00871429|E2|Reported Event|Lindi Skin Face Wash (Product C)|
305230|NCT00871429|E1|Reported Event|Lindi Skin Soothing Balm (Product A)|
305231|NCT00871403|B4|Baseline|Total|Total of all reporting groups
305232|NCT00871403|B3|Baseline|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305233|NCT00871403|B2|Baseline|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305234|NCT00871403|B1|Baseline|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
305235|NCT00871403|P3|Participant Flow|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305236|NCT00871403|P2|Participant Flow|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305237|NCT00871403|P1|Participant Flow|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
305238|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305239|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305240|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305241|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305242|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305243|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305244|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305245|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305246|NCT00871403|E3|Reported Event|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
305247|NCT00871403|E2|Reported Event|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
305248|NCT00871403|E1|Reported Event|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
305254|NCT00871377|P2|Participant Flow|P H L|Placebo, then High Dose, then Low Dose
305257|NCT00871377|O2|Outcome|Fish Oil Low Dose|Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
305258|NCT00871377|O1|Outcome|Placebo|Corn Oil - 6 capsules per day
305259|NCT00871377|E3|Reported Event|Placebo|Corn Oil Placebo
305260|NCT00871377|E2|Reported Event|Low Dose|Low Dose Fish Oil Intervention
305261|NCT00871377|E1|Reported Event|High Dose|High Dose Fish Oil Intervention
305262|NCT00871351|B4|Baseline|Total|Total of all reporting groups
305263|NCT00871351|B3|Baseline|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305264|NCT00871351|B2|Baseline|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305265|NCT00871351|B1|Baseline|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305266|NCT00871351|P3|Participant Flow|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305267|NCT00871351|P2|Participant Flow|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305268|NCT00871351|P1|Participant Flow|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305269|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305270|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305271|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305272|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305273|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305274|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305275|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305276|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305277|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305278|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305279|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305280|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305281|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305282|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305283|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305284|NCT00871351|E3|Reported Event|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305285|NCT00871351|E2|Reported Event|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305286|NCT00871351|E1|Reported Event|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
305287|NCT00871338|B3|Baseline|Total|Total of all reporting groups
305288|NCT00871338|B2|Baseline|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305289|NCT00871338|B1|Baseline|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305303|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305290|NCT00871338|P2|Participant Flow|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305291|NCT00871338|P1|Participant Flow|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305292|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305293|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305294|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305295|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305296|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305297|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305298|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305299|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305300|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305301|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305302|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305475|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305304|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305305|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305306|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305307|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305308|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305309|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305310|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305311|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305312|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305313|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305314|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305315|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305316|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305476|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305317|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305318|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305319|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305320|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305321|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305322|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305323|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305324|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305325|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305326|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305327|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305328|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305329|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305371|NCT00871286|P2|Participant Flow|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305330|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305331|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305332|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305333|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305334|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305335|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305336|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305337|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305338|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305339|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305340|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305341|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305342|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305541|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
316937|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
305343|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305344|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305345|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305346|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305347|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305348|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305349|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305350|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305351|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305352|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305353|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305354|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305355|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305372|NCT00871286|P1|Participant Flow|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305373|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
305356|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305357|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305358|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305359|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305360|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305361|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305362|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305363|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305364|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305365|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305366|NCT00871338|E2|Reported Event|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
305367|NCT00871338|E1|Reported Event|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
305368|NCT00871286|B3|Baseline|Total|Total of all reporting groups
305369|NCT00871286|B2|Baseline|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305370|NCT00871286|B1|Baseline|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305374|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
305375|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
305377|NCT00871286|E2|Reported Event|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305378|NCT00871286|E1|Reported Event|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
305379|NCT00871234|B1|Baseline|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
305380|NCT00871234|P1|Participant Flow|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
305381|NCT00871234|O1|Outcome|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
305382|NCT00871234|E1|Reported Event|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
305383|NCT00871169|B1|Baseline|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
305384|NCT00871169|P1|Participant Flow|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
305385|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
305386|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
305387|NCT00871169|E1|Reported Event|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
305388|NCT00871143|B3|Baseline|Total|Total of all reporting groups
305389|NCT00871143|B2|Baseline|Non Specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
305390|NCT00871143|B1|Baseline|CBT Specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
305391|NCT00871143|P2|Participant Flow|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305392|NCT00871143|P1|Participant Flow|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305393|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305394|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305395|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305396|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305397|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305398|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305399|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305400|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305401|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305402|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305403|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305404|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305405|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305406|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305407|NCT00871143|E2|Reported Event|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
305408|NCT00871143|E1|Reported Event|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
305409|NCT00871117|B3|Baseline|Total|Total of all reporting groups
305410|NCT00871117|B2|Baseline|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305668|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
316938|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
305411|NCT00871117|B1|Baseline|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305412|NCT00871117|P2|Participant Flow|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305413|NCT00871117|P1|Participant Flow|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305414|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305415|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305416|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305417|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305418|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305419|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305420|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305421|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305422|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305423|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305424|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305425|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305426|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305427|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305428|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305429|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305430|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305431|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305477|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305432|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305433|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305434|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305435|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305436|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305437|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305438|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305439|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
305440|NCT00871117|E2|Reported Event|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
305441|NCT00871117|E1|Reported Event|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.
305442|NCT00870896|B1|Baseline|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
305443|NCT00870896|P1|Participant Flow|Group 1|Capsaicin Inhalation challenge (CIH): Each solution of capsaicin administered to a subject will be quantified by HPLC. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals. CIH is administered at baseline one and 3 months following treatment with Spiriva
305444|NCT00870896|O1|Outcome|Change in FEV1/FVC|We measured the change in FEV1/FVC ratio before and after treatment with Spiriva. Change in ratio reflects the percentage value at 30 days minus the percentage value at baseline
305445|NCT00870896|O1|Outcome|Spirometry|We measured the change in FEV1 (in liters) at baseline and following 30 days of treatment with Spiriva.Spirometry will be performed with a KoKO Spirometer, which uses a pneumotachograph to provide Flow/Volume Loops and Volume/Time graphics and multiple incentive graphics for patient coaching. Spirometry will be performed at baseline and at 4 weeks. Normal values will be those of Hankinson, et al (Am J Respir Crit Care Med 159:179-187). Spirometry will also be performed after each dose of inhaled capsaicin. If there is a drop of 20% or more in FEV1 at any time after inhalation of capsaicin, the protocol will be ended at that point.
305446|NCT00870896|O1|Outcome|Group 1|Capsaicin Inhalation Challenge Testing (CICT) will follow the protocol of Dicpinigaitis et al (Chest 2003; 123:685-8). CICT will be performed at baseline before beginning treatment with tiotropium and at 4 weeks after initiation of treatment. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until five or more coughs (C5) are reached. We measured the change in the number of coughs at baseline and following 30 days of treatment with spiriva
305478|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305669|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305447|NCT00870896|E1|Reported Event|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
305448|NCT00870740|B7|Baseline|Total|Total of all reporting groups
305449|NCT00870740|B6|Baseline|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305450|NCT00870740|B5|Baseline|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305451|NCT00870740|B4|Baseline|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305452|NCT00870740|B3|Baseline|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305453|NCT00870740|B2|Baseline|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305454|NCT00870740|B1|Baseline|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305455|NCT00870740|P6|Participant Flow|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305456|NCT00870740|P5|Participant Flow|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305457|NCT00870740|P4|Participant Flow|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305458|NCT00870740|P3|Participant Flow|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305459|NCT00870740|P2|Participant Flow|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305460|NCT00870740|P1|Participant Flow|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305461|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305462|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305463|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305464|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305465|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305466|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305467|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
305468|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
305469|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
305470|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305471|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305472|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305473|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305474|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305479|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305480|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305481|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305482|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305483|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305484|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305485|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305486|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305487|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305488|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305489|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305490|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305491|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305492|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305493|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305494|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305495|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305496|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305497|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305498|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305499|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305500|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
305501|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
305502|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
305503|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
305504|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
305505|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
305506|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305507|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305508|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305509|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305510|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305511|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305512|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
305513|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
305514|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
305515|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305516|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305517|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305518|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305519|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305520|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305521|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305522|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305523|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305524|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305525|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305526|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305527|NCT00870740|E6|Reported Event|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
305528|NCT00870740|E5|Reported Event|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
305529|NCT00870740|E4|Reported Event|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
305530|NCT00870740|E3|Reported Event|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
305531|NCT00870740|E2|Reported Event|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
305532|NCT00870740|E1|Reported Event|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
305533|NCT00870688|B1|Baseline|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
305534|NCT00870688|P1|Participant Flow|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
305535|NCT00870688|O1|Outcome|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
305536|NCT00870584|B3|Baseline|Total|Total of all reporting groups
305537|NCT00870584|B2|Baseline|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
305538|NCT00870584|B1|Baseline|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
305539|NCT00870584|P2|Participant Flow|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
305540|NCT00870584|P1|Participant Flow|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
305542|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
305543|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
305544|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
305545|NCT00870584|E2|Reported Event|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
305546|NCT00870584|E1|Reported Event|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
305547|NCT00870545|B1|Baseline|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
305548|NCT00870545|P1|Participant Flow|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305549|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305550|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305551|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305552|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305553|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305554|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
305577|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305555|NCT00870545|E1|Reported Event|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
305556|NCT00870467|B3|Baseline|Total|Total of all reporting groups
305557|NCT00870467|B2|Baseline|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305558|NCT00870467|B1|Baseline|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305559|NCT00870467|P6|Participant Flow|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305560|NCT00870467|P5|Participant Flow|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305561|NCT00870467|P4|Participant Flow|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305562|NCT00870467|P3|Participant Flow|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305563|NCT00870467|P2|Participant Flow|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305564|NCT00870467|P1|Participant Flow|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305565|NCT00870467|O1|Outcome|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
305566|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305567|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305568|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305569|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305570|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305571|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305572|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305573|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305574|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305575|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305576|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305578|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305579|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305580|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305581|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305582|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305583|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305584|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305585|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305586|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305587|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305588|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
305589|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305590|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305591|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305592|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305593|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305594|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305595|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305596|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305597|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305598|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305599|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305600|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305702|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
305601|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305602|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305603|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305604|NCT00870467|E3|Reported Event|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
305605|NCT00870467|E2|Reported Event|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305606|NCT00870467|E1|Reported Event|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
305607|NCT00870363|B5|Baseline|Total|Total of all reporting groups
305608|NCT00870363|B4|Baseline|HIV Negative Controls Not on ART|HIV-negative
305609|NCT00870363|B3|Baseline|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305610|NCT00870363|B2|Baseline|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305611|NCT00870363|B1|Baseline|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305612|NCT00870363|P4|Participant Flow|HIV Negative Controls Not on ART|HIV-negative
305613|NCT00870363|P3|Participant Flow|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305614|NCT00870363|P2|Participant Flow|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305615|NCT00870363|P1|Participant Flow|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305616|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305617|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305618|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305619|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305620|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305621|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305703|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
305622|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305623|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305624|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305625|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305626|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305627|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305628|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305629|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305630|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305631|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305632|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305633|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305634|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305635|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305636|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305637|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305638|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305667|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305639|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305640|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
305641|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305642|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305643|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305644|NCT00870363|E4|Reported Event|HIV Negative Controls Not on ART|HIV-negative
305645|NCT00870363|E3|Reported Event|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305646|NCT00870363|E2|Reported Event|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305647|NCT00870363|E1|Reported Event|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
305648|NCT00870194|B3|Baseline|Total|Total of all reporting groups
305649|NCT00870194|B2|Baseline|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305650|NCT00870194|B1|Baseline|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305651|NCT00870194|P2|Participant Flow|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305652|NCT00870194|P1|Participant Flow|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305653|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305654|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305655|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305656|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305657|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305658|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305659|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305660|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305661|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305662|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305663|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305664|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305665|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305666|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305670|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305671|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305672|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305673|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305674|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305675|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305676|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305677|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305678|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305679|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305680|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305681|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305682|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305683|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305684|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305685|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305686|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305687|NCT00870194|E2|Reported Event|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
305688|NCT00870194|E1|Reported Event|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
305689|NCT00870103|B1|Baseline|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
305690|NCT00870103|P1|Participant Flow|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
305691|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
305692|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
305693|NCT00870103|E1|Reported Event|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
305694|NCT00869999|B1|Baseline|Treatment Arm|All patients received treatment with everolimus-rituximab on this single am study
305695|NCT00869999|P1|Participant Flow|Everolimus-Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
305696|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
305697|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
305698|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
305699|NCT00869999|E1|Reported Event|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
305700|NCT00869960|B1|Baseline|Combination Antiretroviral Therapy|Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
305701|NCT00869960|P1|Participant Flow|Antiretroviral Therapy|Healthy volunteers
305710|NCT00869960|E1|Reported Event|Antiretroviral Therapy|Healthy volunteers
305711|NCT00869947|B3|Baseline|Total|Total of all reporting groups
305712|NCT00869947|B2|Baseline|Non-amputee|Non-amputees
305713|NCT00869947|B1|Baseline|Prosthesis|Subjects with transtibial amputation using a passive ankle-foot prosthesis
305714|NCT00869947|P2|Participant Flow|Non-amputees|Non-amputees
305715|NCT00869947|P1|Participant Flow|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
305716|NCT00869947|O3|Outcome|Non-Amputees|
305717|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
305718|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
305719|NCT00869947|O3|Outcome|Non-amputees|
305720|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
305721|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
305722|NCT00869947|O3|Outcome|Non-amputees|
305723|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
305724|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
305725|NCT00869947|E2|Reported Event|Non-amputees|Non-amputees
305726|NCT00869947|E1|Reported Event|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
305727|NCT00869778|B4|Baseline|Total|Total of all reporting groups
305728|NCT00869778|B3|Baseline|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
305729|NCT00869778|B2|Baseline|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
305730|NCT00869778|B1|Baseline|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
305731|NCT00869778|P3|Participant Flow|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305732|NCT00869778|P2|Participant Flow|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305733|NCT00869778|P1|Participant Flow|εPA-44 900μg|Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305734|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305735|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305736|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305737|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305738|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305739|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305740|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305741|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305742|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305743|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305744|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305745|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305746|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305747|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305748|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305749|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305750|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305751|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305752|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305753|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305754|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305755|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305756|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305757|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305758|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
305759|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
305760|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
305761|NCT00869778|O3|Outcome|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
305762|NCT00869778|O2|Outcome|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
305763|NCT00869778|O1|Outcome|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
305764|NCT00869778|E3|Reported Event|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
305765|NCT00869778|E2|Reported Event|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
305766|NCT00869778|E1|Reported Event|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28."
305767|NCT00869622|B3|Baseline|Total|Total of all reporting groups
305768|NCT00869622|B2|Baseline|Placebo Sugar Pill|Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly
305769|NCT00869622|B1|Baseline|Risedronate|Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly
305770|NCT00869622|P2|Participant Flow|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
305771|NCT00869622|P1|Participant Flow|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
305772|NCT00869622|O2|Outcome|Placebo + Calcium and Vitamin D|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
305773|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
305774|NCT00869622|O2|Outcome|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
305775|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
305776|NCT00869622|E2|Reported Event|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
305777|NCT00869622|E1|Reported Event|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
305778|NCT00869609|B3|Baseline|Total|Total of all reporting groups
305779|NCT00869609|B2|Baseline|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305780|NCT00869609|B1|Baseline|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305781|NCT00869609|P2|Participant Flow|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305782|NCT00869609|P1|Participant Flow|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305783|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305784|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305957|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
316939|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
305785|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305786|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305787|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305788|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305789|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305790|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305791|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305792|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305793|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305830|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305958|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305794|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305795|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305796|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305797|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305798|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305799|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305800|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305801|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305802|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305831|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305832|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305959|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
305803|NCT00869609|E2|Reported Event|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305804|NCT00869609|E1|Reported Event|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
305805|NCT00869557|B3|Baseline|Total|Total of all reporting groups
305806|NCT00869557|B2|Baseline|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305807|NCT00869557|B1|Baseline|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305808|NCT00869557|P2|Participant Flow|Atripla|Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305809|NCT00869557|P1|Participant Flow|Stribild|Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305810|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305811|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305812|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305813|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305814|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305815|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305816|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305817|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305818|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305819|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305820|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
305821|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
305822|NCT00869557|E3|Reported Event|All Stribild|The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.
305823|NCT00869557|E2|Reported Event|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
305824|NCT00869557|E1|Reported Event|Stribild|Stribild and placebo to match Atripla were administered during the double-blind phase.
305825|NCT00869518|B3|Baseline|Total|Total of all reporting groups
305826|NCT00869518|B2|Baseline|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305827|NCT00869518|B1|Baseline|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305828|NCT00869518|P2|Participant Flow|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305829|NCT00869518|P1|Participant Flow|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
306313|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
305833|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305834|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305835|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305836|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305837|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305838|NCT00869518|E2|Reported Event|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305839|NCT00869518|E1|Reported Event|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
305840|NCT00869375|B3|Baseline|Total|Total of all reporting groups
305841|NCT00869375|B2|Baseline|ANGIOJET GROUP|3 patients were randomized in this group
305842|NCT00869375|B1|Baseline|CLEARWAY GROUP|3 patients were randomized in this group.
305843|NCT00869375|P2|Participant Flow|ANGIOJET GROUP|3 patients were randomized in this group
305844|NCT00869375|P1|Participant Flow|CLEARWAY GROUP|3 patients were randomized in this group.
305845|NCT00869375|O2|Outcome|ANGIOJET GROUP|3 patients were randomized in this group
305846|NCT00869375|O1|Outcome|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
305847|NCT00869375|O2|Outcome|ANGIOJET GROUP|No patients had distal embolization
305848|NCT00869375|O1|Outcome|CLEARWAY GROUP|No patients had distal embolization
305849|NCT00869375|E2|Reported Event|ANGIOJET GROUP|3 patients were randomized in this group
305850|NCT00869375|E1|Reported Event|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
305851|NCT00869362|B3|Baseline|Total|Total of all reporting groups
305852|NCT00869362|B2|Baseline|Control|Patients receive usual care for diabetes
305853|NCT00869362|B1|Baseline|Diabetes Management Team|Evaluation and management by diabetes management team
305854|NCT00869362|P2|Participant Flow|Control|Patients receive usual care for diabetes
305855|NCT00869362|P1|Participant Flow|Diabetes Management Team|Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.
305856|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
305857|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team
305858|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
305859|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.
305860|NCT00869362|E2|Reported Event|Control|Patients receive usual care for diabetes
305861|NCT00869362|E1|Reported Event|Diabetes Management Team|Evaluation and management by diabetes management team
305862|NCT00869258|B1|Baseline|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
305863|NCT00869258|P1|Participant Flow|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
305864|NCT00869258|O1|Outcome|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
305865|NCT00869258|E1|Reported Event|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
305866|NCT00869167|B3|Baseline|Total|Total of all reporting groups
305867|NCT00869167|B2|Baseline|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305868|NCT00869167|B1|Baseline|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305869|NCT00869167|P2|Participant Flow|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305870|NCT00869167|P1|Participant Flow|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305871|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
305955|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305872|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
305873|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305874|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305875|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305876|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305877|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305878|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305879|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305880|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305881|NCT00869167|E2|Reported Event|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305882|NCT00869167|E1|Reported Event|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
305883|NCT00869141|B3|Baseline|Total|Total of all reporting groups
305884|NCT00869141|B2|Baseline|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305885|NCT00869141|B1|Baseline|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305886|NCT00869141|P2|Participant Flow|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305887|NCT00869141|P1|Participant Flow|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305888|NCT00869141|O2|Outcome|Non-hypertensive Phase Group|Eyes that did not develop hypertensive phase after Ahmed valve implantation
305889|NCT00869141|O1|Outcome|Hypertensive Phase Group|Eyes that developed hypertensive phase after Ahmed valve implantation
305890|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305891|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305892|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305893|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305894|NCT00869141|E2|Reported Event|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305895|NCT00869141|E1|Reported Event|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
305896|NCT00869128|B1|Baseline|Entire Study Population|Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
305897|NCT00869128|P2|Participant Flow|Circadin First|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
305898|NCT00869128|P1|Participant Flow|Placebo First|Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
305899|NCT00869128|O2|Outcome|Circadin|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
305900|NCT00869128|O1|Outcome|Placebo|Subjects were treated for 3 weeks with 1 tablet per night of Placebo
305901|NCT00869089|B1|Baseline|CC-10004|CC-10004 Treatment
305902|NCT00869089|P1|Participant Flow|CC-10004|"CC-10004 treatment:~30mg,oral medication, BID, for 24 weeks (60mg total DAILY)"
305903|NCT00869089|O1|Outcome|CC-10004|CC-10004 treatment
305904|NCT00869089|E1|Reported Event|CC-10004|CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
316940|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
305905|NCT00869050|B1|Baseline|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
305906|NCT00869050|P1|Participant Flow|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
305907|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
305908|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
305909|NCT00869050|E1|Reported Event|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
305910|NCT00868998|B1|Baseline|Treatment|Gemcitabine, Docetaxel, and Capecitabine
305911|NCT00868998|P1|Participant Flow|Treatment|Gemcitabine, Docetaxel, and Capecitabine
305912|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
305913|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
305914|NCT00868998|E1|Reported Event|Treatment|Gemcitabine, Docetaxel, and Capecitabine
305915|NCT00868959|B1|Baseline|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305916|NCT00868959|P1|Participant Flow|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305917|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305918|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305919|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305920|NCT00868959|E1|Reported Event|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
305921|NCT00868790|B1|Baseline|All Randomized Participants|All randomized participants who took at least one dose of study treatment
305922|NCT00868790|P14|Participant Flow|METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)|Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
305923|NCT00868790|P13|Participant Flow|PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)|Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
305924|NCT00868790|P12|Participant Flow|MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
305956|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305925|NCT00868790|P11|Participant Flow|MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
305926|NCT00868790|P10|Participant Flow|MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
305927|NCT00868790|P9|Participant Flow|PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
305928|NCT00868790|P8|Participant Flow|MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
305929|NCT00868790|P7|Participant Flow|MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
305930|NCT00868790|P6|Participant Flow|MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
305931|NCT00868790|P5|Participant Flow|PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
305932|NCT00868790|P4|Participant Flow|MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
305933|NCT00868790|P3|Participant Flow|MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
305934|NCT00868790|P2|Participant Flow|MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
305935|NCT00868790|P1|Participant Flow|PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
305936|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305937|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
305938|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305939|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
305940|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305941|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305942|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
305943|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305944|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
305945|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305946|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305947|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
305948|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305949|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
305950|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305951|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305952|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
305953|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305954|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
305960|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305961|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
305962|NCT00868790|O4|Outcome|MK-3577 BID|Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
305963|NCT00868790|O3|Outcome|MK-3577 PM|Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
305964|NCT00868790|O2|Outcome|MK-3577 AM|Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
305965|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305966|NCT00868790|E5|Reported Event|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
305967|NCT00868790|E4|Reported Event|MK-3577 BID|Participants received 25 mg MK-3577 orally BID for 4 weeks.
305968|NCT00868790|E3|Reported Event|MK-3577 PM|Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
305969|NCT00868790|E2|Reported Event|MK-3577 AM|Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
305970|NCT00868790|E1|Reported Event|Placebo|Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
305971|NCT00868712|B4|Baseline|Total|Total of all reporting groups
305972|NCT00868712|B3|Baseline|3 - Warfarin Use Chronic|Warfarin use >24 months
305973|NCT00868712|B2|Baseline|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
305974|NCT00868712|B1|Baseline|Warfarin Use Short Duration|Warfarin use for less than 6 months
305975|NCT00868712|P3|Participant Flow|3 - Warfarin Use Chronic|Warfarin use >24 months
305976|NCT00868712|P2|Participant Flow|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
305977|NCT00868712|P1|Participant Flow|Warfarin Use Short Duration|Warfarin use for less than 6 months
305978|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
305979|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
305980|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
305981|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
305982|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
305983|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
305984|NCT00868712|E3|Reported Event|3 - Warfarin Use Chronic|Warfarin use >24 months
305985|NCT00868712|E2|Reported Event|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
305986|NCT00868712|E1|Reported Event|Warfarin Use Short Duration|Warfarin use for less than 6 months
305987|NCT00868699|B4|Baseline|Total|Total of all reporting groups
305988|NCT00868699|B3|Baseline|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
305989|NCT00868699|B2|Baseline|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
305990|NCT00868699|B1|Baseline|Placebo|Placebo : Placebo Comparator
305991|NCT00868699|P3|Participant Flow|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
305992|NCT00868699|P2|Participant Flow|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
305993|NCT00868699|P1|Participant Flow|Placebo|Placebo : Placebo Comparator
305994|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
305995|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
305996|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
305997|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
305998|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
305999|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
306000|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
306001|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
306002|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
306003|NCT00868699|E3|Reported Event|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
306004|NCT00868699|E2|Reported Event|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
306005|NCT00868699|E1|Reported Event|Placebo|Placebo : Placebo Comparator
306006|NCT00868530|B1|Baseline|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306007|NCT00868530|P1|Participant Flow|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306109|NCT00868309|P2|Participant Flow|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
306008|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306009|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306010|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306011|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306012|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306013|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306014|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306015|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306016|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306017|NCT00868530|E1|Reported Event|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
306018|NCT00868517|B4|Baseline|Total|Total of all reporting groups
306019|NCT00868517|B3|Baseline|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306020|NCT00868517|B2|Baseline|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306021|NCT00868517|B1|Baseline|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306022|NCT00868517|P3|Participant Flow|Wait-List Control Group|Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.
306023|NCT00868517|P2|Participant Flow|Sham Group Auricular Acupuncture|Received sham group auricular acupuncture.
306024|NCT00868517|P1|Participant Flow|True Group Auricular Acupuncture|Received true group auricular acupuncture.
306025|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306026|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306027|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306028|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306029|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306030|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306031|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306032|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306033|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306034|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306035|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306036|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306037|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306038|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306039|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306040|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306041|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306042|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306043|NCT00868517|E3|Reported Event|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
306044|NCT00868517|E2|Reported Event|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
306045|NCT00868517|E1|Reported Event|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
306046|NCT00868452|B3|Baseline|Total|Total of all reporting groups
306047|NCT00868452|B2|Baseline|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306048|NCT00868452|B1|Baseline|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
306049|NCT00868452|P2|Participant Flow|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306050|NCT00868452|P1|Participant Flow|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
306051|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306052|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306053|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306054|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
306055|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306056|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
306057|NCT00868452|E2|Reported Event|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
306058|NCT00868452|E1|Reported Event|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
306059|NCT00868439|B3|Baseline|Total|Total of all reporting groups
306060|NCT00868439|B2|Baseline|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306061|NCT00868439|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306062|NCT00868439|P2|Participant Flow|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306063|NCT00868439|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306064|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306065|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306066|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306067|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306068|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306069|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306070|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306071|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306072|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306073|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306074|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306075|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306076|NCT00868439|E2|Reported Event|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306077|NCT00868439|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
306078|NCT00868374|B3|Baseline|Total|Total of all reporting groups
306079|NCT00868374|B2|Baseline|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306080|NCT00868374|B1|Baseline|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306081|NCT00868374|P2|Participant Flow|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306082|NCT00868374|P1|Participant Flow|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306083|NCT00868374|O2|Outcome|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306084|NCT00868374|O1|Outcome|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306085|NCT00868374|E2|Reported Event|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306086|NCT00868374|E1|Reported Event|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
306087|NCT00868348|B3|Baseline|Total|Total of all reporting groups
306088|NCT00868348|B2|Baseline|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306089|NCT00868348|B1|Baseline|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306090|NCT00868348|P2|Participant Flow|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306091|NCT00868348|P1|Participant Flow|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306092|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306093|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306094|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306095|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306096|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306097|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306098|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306099|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306100|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306101|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306102|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306103|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306104|NCT00868348|E2|Reported Event|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
306105|NCT00868348|E1|Reported Event|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
306106|NCT00868309|B3|Baseline|Total|Total of all reporting groups
306107|NCT00868309|B2|Baseline|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
306108|NCT00868309|B1|Baseline|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
306110|NCT00868309|P1|Participant Flow|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
306111|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
306112|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
306113|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
306114|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
306115|NCT00868309|E2|Reported Event|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
306116|NCT00868309|E1|Reported Event|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
306117|NCT00868296|B3|Baseline|Total|Total of all reporting groups
306118|NCT00868296|B2|Baseline|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
306119|NCT00868296|B1|Baseline|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
306120|NCT00868296|P2|Participant Flow|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
306121|NCT00868296|P1|Participant Flow|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
306122|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
306123|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
306124|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
306125|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
306236|NCT00868101|P2|Participant Flow|Control|Children who did not receive the preconditioning stimulus
306126|NCT00868296|E2|Reported Event|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
306127|NCT00868296|E1|Reported Event|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
306128|NCT00868231|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
306129|NCT00868231|P6|Participant Flow|Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days."
306130|NCT00868231|P5|Participant Flow|Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
306131|NCT00868231|P4|Participant Flow|Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
306132|NCT00868231|P3|Participant Flow|Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
306133|NCT00868231|P2|Participant Flow|Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
306134|NCT00868231|P1|Participant Flow|Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
306135|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306136|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306137|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306138|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306139|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306140|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306141|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306142|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306143|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306144|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306145|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306146|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306147|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306148|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306149|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306150|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306151|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306152|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306153|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306154|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306155|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306156|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306157|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306158|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306159|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306160|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306161|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306162|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306163|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306164|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306165|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306166|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306167|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306168|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
306169|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306170|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306171|NCT00868231|E3|Reported Event|Placebo|Placebo via inhalation
306172|NCT00868231|E2|Reported Event|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
306173|NCT00868231|E1|Reported Event|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
306174|NCT00868218|B5|Baseline|Total|Total of all reporting groups
306175|NCT00868218|B4|Baseline|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306176|NCT00868218|B3|Baseline|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306177|NCT00868218|B2|Baseline|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306178|NCT00868218|B1|Baseline|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306179|NCT00868218|P4|Participant Flow|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306180|NCT00868218|P3|Participant Flow|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306181|NCT00868218|P2|Participant Flow|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306182|NCT00868218|P1|Participant Flow|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
306183|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
306184|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
306185|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
306186|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
306187|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
306188|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
306189|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
306190|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
316941|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
306191|NCT00868218|O4|Outcome|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306192|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306193|NCT00868218|O2|Outcome|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306194|NCT00868218|O1|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
306195|NCT00868218|E4|Reported Event|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306196|NCT00868218|E3|Reported Event|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306197|NCT00868218|E2|Reported Event|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306198|NCT00868218|E1|Reported Event|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
306199|NCT00868192|B1|Baseline|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306200|NCT00868192|P1|Participant Flow|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306201|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306202|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306203|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306204|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306205|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306206|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306207|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306208|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306209|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306210|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306211|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306212|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306213|NCT00868192|E1|Reported Event|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
306214|NCT00868140|B3|Baseline|Total|Total of all reporting groups
306215|NCT00868140|B2|Baseline|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
306216|NCT00868140|B1|Baseline|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
306217|NCT00868140|P2|Participant Flow|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
306218|NCT00868140|P1|Participant Flow|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
306219|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
306220|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
306221|NCT00868140|O2|Outcome|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
306222|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
306223|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
306224|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
306225|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
306226|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
306227|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
306228|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
306229|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
306230|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
306231|NCT00868140|E2|Reported Event|2/Placebo|"Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months~Placebo: placebo daily"
306232|NCT00868140|E1|Reported Event|1/Pioglitazone|"Pioglitazone in pill form at 45mg twice per day for 6 months~pioglitazone: pioglitazone 45 mg"
306233|NCT00868101|B3|Baseline|Total|Total of all reporting groups
306234|NCT00868101|B2|Baseline|Control|Children who did not receive the preconditioning stimulus
306235|NCT00868101|B1|Baseline|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306237|NCT00868101|P1|Participant Flow|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306238|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
306239|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306240|NCT00868101|O2|Outcome|Control|Children that don´t received the preconditioning stimmulus
306241|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus
306242|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
306243|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306244|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
306245|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306246|NCT00868101|E2|Reported Event|Control|Children who did not receive the preconditioning stimulus
306247|NCT00868101|E1|Reported Event|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
306248|NCT00867659|B1|Baseline|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
306249|NCT00867659|P1|Participant Flow|Cetrotide Acetate|oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
306250|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
306251|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
306252|NCT00867659|E1|Reported Event|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
306253|NCT00867568|B1|Baseline|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306254|NCT00867568|P1|Participant Flow|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306255|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306256|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306257|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306258|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306259|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306260|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306309|NCT00867165|B2|Baseline|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306310|NCT00867165|B1|Baseline|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306261|NCT00867568|E1|Reported Event|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
306262|NCT00867503|B1|Baseline|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306263|NCT00867503|P1|Participant Flow|Bendamustine|Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306264|NCT00867503|O1|Outcome|Median Overall Survival in Days|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306265|NCT00867503|O1|Outcome|Bendamustine Grade 4 Toxicity|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306266|NCT00867503|O1|Outcome|Bendamustine Median Progression Free Surivial in Months|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306267|NCT00867503|E1|Reported Event|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
306268|NCT00867490|B1|Baseline|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
306269|NCT00867490|P1|Participant Flow|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
306270|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306271|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306272|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306273|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306274|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306275|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
306276|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306277|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306278|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306279|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306280|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306311|NCT00867165|P2|Participant Flow|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306312|NCT00867165|P1|Participant Flow|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306281|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306282|NCT00867490|E3|Reported Event|Phase 3 - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
306283|NCT00867490|E2|Reported Event|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
306284|NCT00867490|E1|Reported Event|Phase 1 - Candesartan+HCTZ|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
306285|NCT00867451|B3|Baseline|Total|Total of all reporting groups
306286|NCT00867451|B2|Baseline|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
306287|NCT00867451|B1|Baseline|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
306288|NCT00867451|P2|Participant Flow|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
306289|NCT00867451|P1|Participant Flow|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
306290|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
306291|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
306292|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
306293|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
306294|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
306295|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
306296|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
306297|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
306298|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
306299|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
306300|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
306301|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
306302|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
306303|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
306304|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
306305|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
306306|NCT00867451|E2|Reported Event|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
306307|NCT00867451|E1|Reported Event|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
306308|NCT00867165|B3|Baseline|Total|Total of all reporting groups
306314|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306315|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306316|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306317|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306318|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306319|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306320|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306321|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306322|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306323|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306324|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306325|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306326|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306327|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306328|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306329|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306330|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306331|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306332|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306333|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306334|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306335|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306336|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306337|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306338|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306339|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306340|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306341|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306342|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306343|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306344|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306345|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306346|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306347|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306348|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306349|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306350|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306351|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306352|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306353|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306354|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306355|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306356|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306357|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306358|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306359|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306360|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306361|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306362|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306363|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306364|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306365|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306366|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306367|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306368|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306369|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306370|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306371|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306372|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306373|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306374|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306375|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306376|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306377|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306378|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
316942|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
306379|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306380|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306381|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306382|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306383|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306384|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306385|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306386|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306387|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306388|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306389|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306390|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306391|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306392|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306393|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306394|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306395|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306396|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306397|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306398|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306399|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306400|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306401|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306402|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306403|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306404|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306405|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306406|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306407|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306408|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306409|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306410|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306411|NCT00867165|E2|Reported Event|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
306412|NCT00867165|E1|Reported Event|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
306413|NCT00867139|B4|Baseline|Total|Total of all reporting groups
306414|NCT00867139|B3|Baseline|Open-Labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
306415|NCT00867139|B2|Baseline|Neuraminidase Inhibitor Monotheraphy|Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
306416|NCT00867139|B1|Baseline|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
306417|NCT00867139|P3|Participant Flow|Open-labeled TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
306418|NCT00867139|P2|Participant Flow|Neuraminidase Inhibitor Monotherapy|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
306419|NCT00867139|P1|Participant Flow|TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
306420|NCT00867139|O3|Outcome|Open-lable TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306421|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306422|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306423|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306424|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306425|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receiveTCAD or neuraminidase inhibitor monotherapy.
306426|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306427|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306428|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306429|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306430|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306431|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306432|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306433|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306434|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306435|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306436|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306437|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306438|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306439|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306440|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306441|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306442|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306443|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306444|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306445|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306446|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306447|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306448|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306449|NCT00867139|O1|Outcome|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
306450|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306451|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306452|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306453|NCT00867139|O3|Outcome|Open-labeled TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
306454|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|oseltamivir (50 mg); three times a day for 10 days
306455|NCT00867139|O1|Outcome|TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
306456|NCT00867139|E3|Reported Event|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
306621|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306866|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306457|NCT00867139|E2|Reported Event|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306458|NCT00867139|E1|Reported Event|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
306459|NCT00867035|B3|Baseline|Total|Total of all reporting groups
306460|NCT00867035|B2|Baseline|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306461|NCT00867035|B1|Baseline|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306462|NCT00867035|P2|Participant Flow|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306463|NCT00867035|P1|Participant Flow|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306464|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306465|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306466|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306467|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306468|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306469|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306470|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306471|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306472|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306473|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306474|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306475|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306476|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306477|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306478|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306479|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306480|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306481|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306482|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306483|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306484|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306485|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306486|NCT00867035|E2|Reported Event|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
306487|NCT00867035|E1|Reported Event|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
306488|NCT00867009|B1|Baseline|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306489|NCT00867009|P1|Participant Flow|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306490|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306622|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
316943|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
306491|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306492|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306493|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306494|NCT00867009|E1|Reported Event|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
306495|NCT00866905|B1|Baseline|Arm/Group 1|
306496|NCT00866905|P1|Participant Flow|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours~Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
306497|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
306498|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
306499|NCT00866905|E1|Reported Event|Ixabepilone/Cyclophosphamide|
306500|NCT00866814|B1|Baseline|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306501|NCT00866814|P1|Participant Flow|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306502|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306503|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306504|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306505|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306506|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306507|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306508|NCT00866814|E1|Reported Event|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
306509|NCT00866788|B5|Baseline|Total|Total of all reporting groups
306510|NCT00866788|B4|Baseline|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306511|NCT00866788|B3|Baseline|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306512|NCT00866788|B2|Baseline|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306513|NCT00866788|B1|Baseline|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306514|NCT00866788|P4|Participant Flow|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306515|NCT00866788|P3|Participant Flow|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306516|NCT00866788|P2|Participant Flow|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306517|NCT00866788|P1|Participant Flow|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306518|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306519|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306520|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306521|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306522|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306523|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306524|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306525|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306526|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306527|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306528|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306529|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306530|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306531|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306532|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306533|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306534|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306535|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306536|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306537|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306538|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306867|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306539|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306540|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306541|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306542|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306543|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306544|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306545|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306546|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306547|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306548|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306549|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306550|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306551|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306552|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306553|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306554|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306555|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306556|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306557|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306558|NCT00866788|E4|Reported Event|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306623|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306559|NCT00866788|E3|Reported Event|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306560|NCT00866788|E2|Reported Event|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306561|NCT00866788|E1|Reported Event|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
306562|NCT00866775|B3|Baseline|Total|Total of all reporting groups
306563|NCT00866775|B2|Baseline|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306564|NCT00866775|B1|Baseline|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306565|NCT00866775|P2|Participant Flow|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306566|NCT00866775|P1|Participant Flow|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306567|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306568|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306569|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306570|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306571|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306572|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306573|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306574|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306575|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306576|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306577|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306578|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306579|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306580|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306581|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306582|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306583|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306584|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306624|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306868|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306585|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306586|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306587|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306588|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306589|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306590|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306591|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306592|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306593|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306594|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306595|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306596|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306597|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306598|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306599|NCT00866775|E2|Reported Event|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
306600|NCT00866775|E1|Reported Event|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
306601|NCT00866723|B1|Baseline|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
306602|NCT00866723|P1|Participant Flow|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
306603|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
306604|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
306605|NCT00866723|E1|Reported Event|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
306606|NCT00866697|B3|Baseline|Total|Total of all reporting groups
306607|NCT00866697|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306608|NCT00866697|B1|Baseline|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306609|NCT00866697|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306610|NCT00866697|P1|Participant Flow|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306611|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306612|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306613|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306614|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306615|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306616|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306617|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306618|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306619|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306620|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306625|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306626|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306627|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306628|NCT00866697|O1|Outcome|Placebo|Placebo
306629|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306630|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306631|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306632|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306633|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306634|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306635|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306636|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306637|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306638|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306639|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306640|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306641|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306642|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306643|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306644|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306645|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306646|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306647|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306648|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306649|NCT00866697|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
306650|NCT00866697|E1|Reported Event|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
306651|NCT00866658|B3|Baseline|Total|Total of all reporting groups
306652|NCT00866658|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
306653|NCT00866658|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
306654|NCT00866658|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
306655|NCT00866658|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
306656|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306657|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306658|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306659|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306660|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306661|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306662|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306663|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306664|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306665|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306666|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306667|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306668|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306669|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306670|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306671|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306672|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306673|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306674|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306675|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
316944|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
306676|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306677|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306678|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306679|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306680|NCT00866658|E2|Reported Event|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
306681|NCT00866658|E1|Reported Event|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
306682|NCT00866606|B1|Baseline|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306683|NCT00866606|P1|Participant Flow|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306684|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306685|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306686|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306687|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306688|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306689|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306690|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306691|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306692|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306693|NCT00866606|E1|Reported Event|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
306694|NCT00866359|B3|Baseline|Total|Total of all reporting groups
306695|NCT00866359|B2|Baseline|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306696|NCT00866359|B1|Baseline|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
306697|NCT00866359|P4|Participant Flow|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
306698|NCT00866359|P3|Participant Flow|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
306699|NCT00866359|P2|Participant Flow|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306700|NCT00866359|P1|Participant Flow|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
306716|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
306869|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306701|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306702|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306703|NCT00866359|O2|Outcome|Apremilast 30 mg/Apremilast 30mg BID|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306704|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306705|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306706|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306707|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306708|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306709|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306710|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306711|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306712|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
306713|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
306714|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
306715|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
306717|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
306718|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
306719|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
306720|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
306721|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
306722|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
306723|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
306724|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
306725|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306726|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
306727|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306728|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
306729|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306730|NCT00866359|O1|Outcome|Placebo|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
306731|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306732|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306733|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306734|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
306735|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306736|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306737|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306738|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306739|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306740|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306741|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306742|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
306743|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306744|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306745|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306746|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306747|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
306748|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
306749|NCT00866359|E3|Reported Event|Week 24: Apremilast 30 mg BID|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
306750|NCT00866359|E2|Reported Event|Week 12: Apremilast 30 mg BID|Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID.
306751|NCT00866359|E1|Reported Event|Week 12: Placebo BID|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo.
306752|NCT00866320|B1|Baseline|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
306753|NCT00866320|P1|Participant Flow|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
306754|NCT00866320|O1|Outcome|Sorafenib|Patients receive Sorafenib twice a day until disease progression or toxicity
306755|NCT00866320|O1|Outcome|Sorafenib|Sorafenib twice a day until progression or toxicity
306756|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
306757|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
306758|NCT00866320|E1|Reported Event|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
306759|NCT00866307|B1|Baseline|Induction|All Patients
306760|NCT00866307|P3|Participant Flow|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
306761|NCT00866307|P2|Participant Flow|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
306762|NCT00866307|P1|Participant Flow|Induction|All Patients
306763|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
306764|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
306765|NCT00866307|E3|Reported Event|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
306766|NCT00866307|E2|Reported Event|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
306767|NCT00866307|E1|Reported Event|Induction|All Patients
306768|NCT00866294|B4|Baseline|Total|Total of all reporting groups
306769|NCT00866294|B3|Baseline|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
306770|NCT00866294|B2|Baseline|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
306771|NCT00866294|B1|Baseline|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
306772|NCT00866294|P3|Participant Flow|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
306773|NCT00866294|P2|Participant Flow|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
316945|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
306774|NCT00866294|P1|Participant Flow|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
306775|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306776|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306777|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
306778|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306779|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306780|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
306781|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306782|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306783|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
306784|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306785|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306786|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
306787|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306788|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306789|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
306790|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306865|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306791|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
306792|NCT00866294|O1|Outcome|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
306793|NCT00866294|E7|Reported Event|Paroxetine IR, Total|All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
306794|NCT00866294|E6|Reported Event|Paroxetine IR 20-40 mg/Day|An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
306795|NCT00866294|E5|Reported Event|Paroxetine IR 10-40 mg/Day|An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
306796|NCT00866294|E4|Reported Event|Paroxetine CR, Total|All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
306797|NCT00866294|E3|Reported Event|Paroxetine CR 25-50 mg/Day|An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
306798|NCT00866294|E2|Reported Event|Paroxetine CR 12.5-50 mg/Day|An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
306799|NCT00866294|E1|Reported Event|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
306800|NCT00866281|B3|Baseline|Total|Total of all reporting groups
306801|NCT00866281|B2|Baseline|Cohort 2: Midostaurin (60 mg/m^2)|Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306802|NCT00866281|B1|Baseline|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306803|NCT00866281|P2|Participant Flow|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306804|NCT00866281|P1|Participant Flow|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306805|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306806|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306807|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306808|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306809|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306810|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306811|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306812|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306813|NCT00866281|O2|Outcome|MLLr-ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306814|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
306815|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306816|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306817|NCT00866281|E2|Reported Event|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
306818|NCT00866281|E1|Reported Event|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
306819|NCT00866177|B1|Baseline|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
306820|NCT00866177|P1|Participant Flow|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
306821|NCT00866177|O1|Outcome|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
306822|NCT00866177|E1|Reported Event|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
306823|NCT00866047|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306824|NCT00866047|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
306825|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306826|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306827|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306828|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306829|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306830|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306831|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306832|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306833|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306834|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306835|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306836|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306837|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306838|NCT00866047|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
306839|NCT00866034|B3|Baseline|Total|Total of all reporting groups
306840|NCT00866034|B2|Baseline|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
306841|NCT00866034|B1|Baseline|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
306842|NCT00866034|P2|Participant Flow|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
306843|NCT00866034|P1|Participant Flow|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
306844|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
306845|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
306846|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
306847|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
306848|NCT00866034|E2|Reported Event|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
306849|NCT00866034|E1|Reported Event|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
306850|NCT00865904|B6|Baseline|Total|Total of all reporting groups
306851|NCT00865904|B5|Baseline|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306852|NCT00865904|B4|Baseline|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306853|NCT00865904|B3|Baseline|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306854|NCT00865904|B2|Baseline|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306855|NCT00865904|B1|Baseline|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306856|NCT00865904|P5|Participant Flow|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306857|NCT00865904|P4|Participant Flow|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306858|NCT00865904|P3|Participant Flow|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306859|NCT00865904|P2|Participant Flow|VX-809, 25 mg|VX-809, 25 milligram (mg) capsule orally once daily for 28 days.
306860|NCT00865904|P1|Participant Flow|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306861|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306862|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306863|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306864|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306870|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306871|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306872|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306873|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306874|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306875|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306876|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306877|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306878|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306879|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306880|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306881|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306882|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306883|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306884|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306885|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306886|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306887|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306888|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306889|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306890|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306891|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306892|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306893|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306894|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306895|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306896|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306897|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306898|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306899|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306900|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306901|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306902|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306903|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306904|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306905|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306906|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306907|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306908|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306909|NCT00865904|E5|Reported Event|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
306910|NCT00865904|E4|Reported Event|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
306911|NCT00865904|E3|Reported Event|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
306912|NCT00865904|E2|Reported Event|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
306913|NCT00865904|E1|Reported Event|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
306914|NCT00865709|B3|Baseline|Total|Total of all reporting groups
306915|NCT00865709|B2|Baseline|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306916|NCT00865709|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306917|NCT00865709|P2|Participant Flow|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306918|NCT00865709|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306919|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306920|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306921|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
316946|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
306922|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306923|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306924|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306925|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306926|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306927|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306928|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306929|NCT00865709|E4|Reported Event|Matching Placebo + mFOLFOX6 (OS Update)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306930|NCT00865709|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306931|NCT00865709|E2|Reported Event|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
306932|NCT00865709|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
306933|NCT00865514|B1|Baseline|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
306934|NCT00865514|P1|Participant Flow|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
306935|NCT00865514|O1|Outcome|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
306936|NCT00865514|O1|Outcome|The Interaction of DCA and/or Tyrosine Breakdown Products|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
306937|NCT00865514|E1|Reported Event|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
306938|NCT00865345|B1|Baseline|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
306939|NCT00865345|P1|Participant Flow|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
306940|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
306941|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
306942|NCT00865345|E1|Reported Event|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
306943|NCT00865306|B3|Baseline|Total|Total of all reporting groups
306944|NCT00865306|B2|Baseline|No Intervention (Wait-list Controls)|
306945|NCT00865306|B1|Baseline|Active CBT|
306946|NCT00865306|P2|Participant Flow|No Intervention (Wait-list Controls)|This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.
306947|NCT00865306|P1|Participant Flow|Active CBT|This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
306948|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
306949|NCT00865306|O1|Outcome|Active CBT|
306950|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
306951|NCT00865306|O1|Outcome|Active CBT|
306952|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
306953|NCT00865306|O1|Outcome|Active CBT|
306954|NCT00865306|E2|Reported Event|No Intervention (Wait-list Controls)|
306955|NCT00865306|E1|Reported Event|Active CBT|
306956|NCT00865098|B1|Baseline|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306957|NCT00865098|P1|Participant Flow|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306958|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306959|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306960|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306961|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306962|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306963|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306964|NCT00865098|E1|Reported Event|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
306965|NCT00865046|B4|Baseline|Total|Total of all reporting groups
306966|NCT00865046|B3|Baseline|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306967|NCT00865046|B2|Baseline|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
307063|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
306968|NCT00865046|B1|Baseline|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
306969|NCT00865046|P3|Participant Flow|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306970|NCT00865046|P2|Participant Flow|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306971|NCT00865046|P1|Participant Flow|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
306972|NCT00865046|O3|Outcome|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306973|NCT00865046|O2|Outcome|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306974|NCT00865046|O1|Outcome|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
306975|NCT00865046|E3|Reported Event|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306976|NCT00865046|E2|Reported Event|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
306977|NCT00865046|E1|Reported Event|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
306978|NCT00865020|B3|Baseline|Total|Total of all reporting groups
306979|NCT00865020|B2|Baseline|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306980|NCT00865020|B1|Baseline|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306981|NCT00865020|P2|Participant Flow|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306982|NCT00865020|P1|Participant Flow|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306983|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306984|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306985|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306986|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306987|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
307013|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
306988|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306989|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306990|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306991|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306992|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306993|NCT00865020|E2|Reported Event|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
306994|NCT00865020|E1|Reported Event|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
306995|NCT00864916|B3|Baseline|Total|Total of all reporting groups
306996|NCT00864916|B2|Baseline|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
306997|NCT00864916|B1|Baseline|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
306998|NCT00864916|P2|Participant Flow|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
306999|NCT00864916|P1|Participant Flow|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
307000|NCT00864916|O2|Outcome|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
307001|NCT00864916|O1|Outcome|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
307002|NCT00864916|E2|Reported Event|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
307003|NCT00864916|E1|Reported Event|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
307004|NCT00864851|B4|Baseline|Total|Total of all reporting groups
307005|NCT00864851|B3|Baseline|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307006|NCT00864851|B2|Baseline|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307007|NCT00864851|B1|Baseline|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307008|NCT00864851|P3|Participant Flow|Replagal 0.4 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307009|NCT00864851|P2|Participant Flow|Replagal 0.2 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307010|NCT00864851|P1|Participant Flow|Replagal 0.2 mg/kg, IV, Every Other Week|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307011|NCT00864851|O4|Outcome|Overall|Total of all reporting groups.
307012|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307062|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307014|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307015|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307016|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307017|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307018|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307019|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307020|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307021|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307022|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307023|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307024|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307025|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307026|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307027|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307028|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307029|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307030|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307031|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307032|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307033|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307034|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307035|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307036|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307037|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307038|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307039|NCT00864851|E4|Reported Event|Overall|Total of all reporting groups.
307040|NCT00864851|E3|Reported Event|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
307041|NCT00864851|E2|Reported Event|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
307042|NCT00864851|E1|Reported Event|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
307043|NCT00864708|B1|Baseline|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
307044|NCT00864708|P1|Participant Flow|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307045|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307046|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307047|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307048|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307049|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
307050|NCT00864708|O1|Outcome|Arm 1|gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
307051|NCT00864708|E1|Reported Event|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
307052|NCT00864682|B4|Baseline|Total|Total of all reporting groups
307053|NCT00864682|B3|Baseline|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307054|NCT00864682|B2|Baseline|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
307055|NCT00864682|B1|Baseline|Control Arm|saline pretreatment, saline plus propofol admixture
307056|NCT00864682|P3|Participant Flow|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307057|NCT00864682|P2|Participant Flow|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
307058|NCT00864682|P1|Participant Flow|Control Arm|saline pretreatment, saline plus propofol admixture
307059|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307060|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
307061|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
316947|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
307064|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
307065|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307066|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
307067|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
307068|NCT00864682|E3|Reported Event|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
307069|NCT00864682|E2|Reported Event|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
307070|NCT00864682|E1|Reported Event|Control Arm|saline pretreatment, saline plus propofol admixture
307071|NCT00864539|B7|Baseline|Total|Total of all reporting groups
307072|NCT00864539|B6|Baseline|Placebo|Subjects receiving daily placebo containing 1 g starch
307073|NCT00864539|B5|Baseline|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
307074|NCT00864539|B4|Baseline|Plain Juice|subjects receiving plain orange juice
307075|NCT00864539|B3|Baseline|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
307076|NCT00864539|B2|Baseline|Plain Milk|daily intake of 200 mL plain milk
307077|NCT00864539|B1|Baseline|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
307078|NCT00864539|P6|Participant Flow|Placebo|Subjects receiving daily placebo containing 1 g starch
307079|NCT00864539|P5|Participant Flow|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
307080|NCT00864539|P4|Participant Flow|Plain Juice|subjects receiving plain orange juice
307081|NCT00864539|P3|Participant Flow|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
307082|NCT00864539|P2|Participant Flow|Plain Milk|daily intake of 200 mL plain milk
307083|NCT00864539|P1|Participant Flow|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
307084|NCT00864539|O6|Outcome|Placebo|Subjects receiving daily placebo containing 1 g starch
307085|NCT00864539|O5|Outcome|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
307086|NCT00864539|O4|Outcome|Plain Juice|subjects receiving plain orange juice
307087|NCT00864539|O3|Outcome|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
307088|NCT00864539|O2|Outcome|Plain Milk|daily intake of 200 mL plain milk
307089|NCT00864539|O1|Outcome|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
307090|NCT00864539|E6|Reported Event|Placebo|Subjects receiving daily placebo containing 1 g starch
307091|NCT00864539|E5|Reported Event|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
307092|NCT00864539|E4|Reported Event|Plain Juice|subjects receiving plain orange juice
307093|NCT00864539|E3|Reported Event|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
307094|NCT00864539|E2|Reported Event|Plain Milk|daily intake of 200 mL plain milk
307095|NCT00864539|E1|Reported Event|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
307096|NCT00864513|B1|Baseline|Chemotherapy|pemetrexed
307097|NCT00864513|P1|Participant Flow|Chemotherapy|Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
307098|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
307099|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
307100|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
307101|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
307102|NCT00864513|E1|Reported Event|Chemotherapy|pemetrexed
307103|NCT00864383|B4|Baseline|Total|Total of all reporting groups
307104|NCT00864383|B3|Baseline|Regimen 3 - 2EMRZ/2MR (Ethambutol)|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307105|NCT00864383|B2|Baseline|Regimen 2 - 2MHRZ/2MHR (Isoniazid)|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307151|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307152|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307153|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307154|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307106|NCT00864383|B1|Baseline|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307107|NCT00864383|P3|Participant Flow|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307108|NCT00864383|P2|Participant Flow|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307109|NCT00864383|P1|Participant Flow|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307110|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307111|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307112|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307113|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307114|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307277|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307115|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307116|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307117|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307118|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307119|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307120|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307121|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307122|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307123|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307278|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307124|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307125|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307126|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307127|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307128|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307129|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307130|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307131|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307132|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307279|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307133|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307134|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307135|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307136|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307137|NCT00864383|E3|Reported Event|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307138|NCT00864383|E2|Reported Event|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307139|NCT00864383|E1|Reported Event|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
307140|NCT00864253|B3|Baseline|Total|Total of all reporting groups
307141|NCT00864253|B2|Baseline|Dacarbazine Arm B 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307142|NCT00864253|B1|Baseline|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307143|NCT00864253|P2|Participant Flow|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307144|NCT00864253|P1|Participant Flow|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307145|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307146|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307147|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307148|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307149|NCT00864253|O2|Outcome|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307150|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307155|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307156|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307157|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307158|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307159|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307160|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307161|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307162|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307163|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307164|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307165|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307166|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307167|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307168|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307169|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307170|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 every 4 weeks
307171|NCT00864253|E2|Reported Event|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
307172|NCT00864253|E1|Reported Event|ABI-007 Arm A|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
307173|NCT00864227|B1|Baseline|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307174|NCT00864227|P1|Participant Flow|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307175|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307176|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307177|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307178|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307179|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307180|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307181|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307182|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307183|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307184|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307185|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307186|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307187|NCT00864227|E1|Reported Event|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
307188|NCT00864123|B3|Baseline|Total|Total of all reporting groups
307189|NCT00864123|B2|Baseline|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307190|NCT00864123|B1|Baseline|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307191|NCT00864123|P2|Participant Flow|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307192|NCT00864123|P1|Participant Flow|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307193|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307280|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307194|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307195|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307196|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307197|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307198|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307199|NCT00864123|E2|Reported Event|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307200|NCT00864123|E1|Reported Event|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
307201|NCT00864084|B1|Baseline|Pulmonary Rehabilitation|People with respiratory disease
307202|NCT00864084|P1|Participant Flow|Pulmonary Rehabilitation|An 8-week out-patient pulmonary rehabilitation program.
307203|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307204|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307205|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307206|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307207|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307208|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307209|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307210|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307211|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
307212|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
307213|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
307214|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
307215|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
307216|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
307217|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
307218|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
307219|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307220|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307221|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
307222|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
307223|NCT00864084|E1|Reported Event|Study Participation|Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation).
307224|NCT00864032|B1|Baseline|Phase I|
307225|NCT00864032|P3|Participant Flow|Sorafenib 400/400|"Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
307226|NCT00864032|P2|Participant Flow|Sorafenib 200/400|"Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.~Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1."
307227|NCT00864032|P1|Participant Flow|Sorafenib 200/200|"Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
307228|NCT00864032|O2|Outcome|Sorafenib 200/400|
307229|NCT00864032|O1|Outcome|Sorafenib 200/200|
307230|NCT00864032|E2|Reported Event|Sorafenib 200/400|Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM
307231|NCT00864032|E1|Reported Event|Sorafenib 200/200|Dose level 1. Sorafenib 200 mg PO BID
307232|NCT00863798|B4|Baseline|Total|Total of all reporting groups
307233|NCT00863798|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307234|NCT00863798|B2|Baseline|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307235|NCT00863798|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307236|NCT00863798|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307237|NCT00863798|P2|Participant Flow|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307238|NCT00863798|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307239|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307240|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307241|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307242|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307243|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307244|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307245|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307246|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307247|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307248|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307249|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307250|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307251|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307252|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307253|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307254|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307255|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307256|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307257|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307258|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307259|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307260|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307261|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307262|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307263|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307264|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307265|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307266|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307267|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307268|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307269|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307270|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307271|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307272|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307273|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307274|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307275|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307276|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307281|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307282|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307283|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307284|NCT00863798|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
307285|NCT00863798|E2|Reported Event|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
307286|NCT00863798|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
307287|NCT00863746|B3|Baseline|Total|Total of all reporting groups
307288|NCT00863746|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307289|NCT00863746|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307290|NCT00863746|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307291|NCT00863746|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307292|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307293|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307294|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307295|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307296|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307297|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307298|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307299|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307300|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307301|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307302|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307303|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307304|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307305|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307306|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307307|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307308|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307309|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307310|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307311|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
307312|NCT00863746|E2|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
307313|NCT00863746|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)
307314|NCT00863707|B3|Baseline|Total|Total of all reporting groups
307315|NCT00863707|B2|Baseline|Regadenoson|0.4 mg/5 mL intravenous bolus injection
307316|NCT00863707|B1|Baseline|Placebo|Matching intravenous (IV) bolus injection
307317|NCT00863707|P2|Participant Flow|Regadenoson|0.4 mg/5 mL intravenous bolus injection
307318|NCT00863707|P1|Participant Flow|Placebo|Matching intravenous (IV) bolus injection
307319|NCT00863707|O2|Outcome|Regadenoson|0.4 mg/5 mL intravenous bolus injection
307320|NCT00863707|O1|Outcome|Placebo|Matching intravenous (IV) bolus injection
307321|NCT00863707|E2|Reported Event|Regadenoson|0.4 mg/5 mL intravenous bolus injection
307322|NCT00863707|E1|Reported Event|Placebo|Matching intravenous (IV) bolus injection
307323|NCT00863655|B3|Baseline|Total|Total of all reporting groups
307324|NCT00863655|B2|Baseline|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
307325|NCT00863655|B1|Baseline|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
307326|NCT00863655|P2|Participant Flow|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
307327|NCT00863655|P1|Participant Flow|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
307328|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
307329|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
307330|NCT00863655|E2|Reported Event|Placebo@+Exemestane|Placebo@+exemestane
307331|NCT00863655|E1|Reported Event|Everolimus 10mg@+Exemestane|Everolimus 10mg@+exemestane
307332|NCT00863551|B1|Baseline|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307333|NCT00863551|P1|Participant Flow|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307334|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307335|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307336|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307337|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307338|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307339|NCT00863551|E1|Reported Event|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
307340|NCT00863356|B1|Baseline|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
307341|NCT00863356|P1|Participant Flow|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
307342|NCT00863356|O1|Outcome|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
307343|NCT00863356|E1|Reported Event|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
307344|NCT00863343|B3|Baseline|Total|Total of all reporting groups
307345|NCT00863343|B2|Baseline|Participants w/o Disease|Participants without Flu A by reference method
307346|NCT00863343|B1|Baseline|Participants w/ Disease|Positive for Flu A by reference test
307347|NCT00863343|P2|Participant Flow|Participants w/o Disease|Participants without Flu A by reference method
307348|NCT00863343|P1|Participant Flow|Participants w/ Disease|Positive for Flu A by reference test
307349|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
307350|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
307351|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
307352|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
307353|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
307354|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
307355|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
307356|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
307357|NCT00863343|E2|Reported Event|Participants w/o Disease|Participants without Flu by reference method
307358|NCT00863343|E1|Reported Event|Participants With Disease|Positive for Flu by reference test
307359|NCT00863330|B1|Baseline|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
307360|NCT00863330|P1|Participant Flow|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
307361|NCT00863330|O1|Outcome|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
307362|NCT00863330|E1|Reported Event|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
307363|NCT00863317|B3|Baseline|Total|Total of all reporting groups
307364|NCT00863317|B2|Baseline|Sucrose|sucrose: table sugar as placebo daily for 14 days
307365|NCT00863317|B1|Baseline|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
307366|NCT00863317|P2|Participant Flow|Placebo|sucrose: table sugar as placebo daily for 14 days
307367|NCT00863317|P1|Participant Flow|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
307368|NCT00863317|O2|Outcome|Placebo|sucrose: table sugar as placebo daily for 14 days
307369|NCT00863317|O1|Outcome|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
307370|NCT00863317|E2|Reported Event|Placebo|sucrose: table sugar as placebo daily for 14 days
307371|NCT00863317|E1|Reported Event|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
307372|NCT00863109|B1|Baseline|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307482|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307373|NCT00863109|P1|Participant Flow|PEG + RBV (Standard Clinical Practice)|Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307374|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
307375|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
307376|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307377|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307378|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
307379|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
307380|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
307381|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
307382|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307383|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307384|NCT00863109|E1|Reported Event|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
307385|NCT00863057|B5|Baseline|Total|Total of all reporting groups
307386|NCT00863057|B4|Baseline|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307387|NCT00863057|B3|Baseline|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307388|NCT00863057|B2|Baseline|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307389|NCT00863057|B1|Baseline|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307405|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307483|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307915|NCT00862121|B2|Baseline|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307390|NCT00863057|P4|Participant Flow|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307391|NCT00863057|P3|Participant Flow|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307392|NCT00863057|P2|Participant Flow|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307393|NCT00863057|P1|Participant Flow|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
307394|NCT00863057|O2|Outcome|Duloxetine|Maximum tolerated daily dose of Duloxetine was reported.
307395|NCT00863057|O1|Outcome|Methadone|Maximum tolerated daily dose of Methadone was reported.
307396|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307397|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307398|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307399|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307400|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307401|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307402|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307403|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307404|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307479|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307406|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307407|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307408|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307409|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307410|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307411|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307412|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307413|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307414|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307415|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307416|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307417|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307418|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307419|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307420|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307421|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307422|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307423|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307424|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307480|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307916|NCT00862121|B1|Baseline|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307425|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307426|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307427|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
307428|NCT00863057|E4|Reported Event|Duloxetine Placebo and Methadone Placebo|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
307429|NCT00863057|E3|Reported Event|Duloxetine Placebo and Methadone|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
307430|NCT00863057|E2|Reported Event|Duloxetine and Methadone Placebo|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
307431|NCT00863057|E1|Reported Event|Duloxetine and Methadone|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
307432|NCT00862940|B3|Baseline|Total|Total of all reporting groups
307433|NCT00862940|B2|Baseline|Placebo Tablets Twice Daily|
307434|NCT00862940|B1|Baseline|Memantine 10 mg Tablets Twice Daily|
307435|NCT00862940|P2|Participant Flow|Placebo Tablets Twice Daily|
307436|NCT00862940|P1|Participant Flow|Memantine 10 mg Tablets Twice Daily|
307437|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
307438|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
307439|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
307440|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
307441|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
307442|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
307443|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
307444|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
307445|NCT00862940|E2|Reported Event|Placebo Tablets Twice Daily|
307446|NCT00862940|E1|Reported Event|Memantine 10 mg Tablets Twice Daily|
307447|NCT00862849|B1|Baseline|All Participants|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).~Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions.~The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections."
307448|NCT00862849|P6|Participant Flow|Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307449|NCT00862849|P5|Participant Flow|Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307450|NCT00862849|P4|Participant Flow|RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307481|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307451|NCT00862849|P3|Participant Flow|RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307452|NCT00862849|P2|Participant Flow|Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307453|NCT00862849|P1|Participant Flow|Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
307454|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307455|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307456|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307457|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307458|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307459|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307460|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307461|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307462|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307463|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307464|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307465|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307466|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307467|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307468|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307469|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307470|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307471|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307472|NCT00862849|E3|Reported Event|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
307473|NCT00862849|E2|Reported Event|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307474|NCT00862849|E1|Reported Event|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
307475|NCT00862836|B1|Baseline|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307476|NCT00862836|P1|Participant Flow|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307477|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307478|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307484|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307485|NCT00862836|E1|Reported Event|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
307486|NCT00862823|B1|Baseline|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
307487|NCT00862823|P2|Participant Flow|Liquid First, Then Tablet|Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
307488|NCT00862823|P1|Participant Flow|Tablet First, Then Liquid|Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period
307489|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
307490|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
307491|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
307492|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
307493|NCT00862823|E1|Reported Event|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
307494|NCT00862810|B3|Baseline|Total|Total of all reporting groups
307495|NCT00862810|B2|Baseline|Received Concomitant Vaccines First|Received concomitant vaccines first
307496|NCT00862810|B1|Baseline|Received HPV Vaccine First|Received HPV vaccine first
307497|NCT00862810|P2|Participant Flow|Received Concomitant Vaccines First|Received Concomitant Vaccines First
307498|NCT00862810|P1|Participant Flow|Received HPV Vaccine First|Received HPV vaccine first
307499|NCT00862810|O2|Outcome|Received Concomitant Vaccines First|Received concomitant vaccines first
307500|NCT00862810|O1|Outcome|Received HPV Vaccine First|Received HPV vaccine first
307501|NCT00862810|E2|Reported Event|Received Concomitant Vaccines First|Received concomitant vaccines first
307502|NCT00862810|E1|Reported Event|Received HPV Vaccine First|Received HPV vaccine first
307503|NCT00862784|B1|Baseline|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307504|NCT00862784|P1|Participant Flow|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307505|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307506|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307507|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307508|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307541|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307542|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307509|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307510|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307511|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307512|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307513|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307514|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307515|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307516|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307517|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307543|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307544|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307545|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307518|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307519|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307520|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307521|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307522|NCT00862784|E1|Reported Event|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
307523|NCT00862745|B3|Baseline|Total|Total of all reporting groups
307524|NCT00862745|B2|Baseline|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
307525|NCT00862745|B1|Baseline|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
307526|NCT00862745|P2|Participant Flow|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
307527|NCT00862745|P1|Participant Flow|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
307528|NCT00862745|O2|Outcome|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
307529|NCT00862745|O1|Outcome|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
307530|NCT00862745|E2|Reported Event|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
307531|NCT00862745|E1|Reported Event|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
307532|NCT00862719|B5|Baseline|Total|Total of all reporting groups
307533|NCT00862719|B4|Baseline|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307534|NCT00862719|B3|Baseline|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307535|NCT00862719|B2|Baseline|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307536|NCT00862719|B1|Baseline|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307537|NCT00862719|P4|Participant Flow|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307538|NCT00862719|P3|Participant Flow|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307539|NCT00862719|P2|Participant Flow|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307540|NCT00862719|P1|Participant Flow|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307917|NCT00862121|P2|Participant Flow|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307546|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307547|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307548|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307549|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307550|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307551|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307552|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307553|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307554|NCT00862719|E4|Reported Event|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
307555|NCT00862719|E3|Reported Event|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
307556|NCT00862719|E2|Reported Event|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
307557|NCT00862719|E1|Reported Event|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
307558|NCT00862654|B5|Baseline|Total|Total of all reporting groups
307559|NCT00862654|B4|Baseline|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
307560|NCT00862654|B3|Baseline|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
307561|NCT00862654|B2|Baseline|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
307562|NCT00862654|B1|Baseline|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
307563|NCT00862654|P4|Participant Flow|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
307564|NCT00862654|P3|Participant Flow|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
307565|NCT00862654|P2|Participant Flow|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
307566|NCT00862654|P1|Participant Flow|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
307567|NCT00862654|O4|Outcome|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
307568|NCT00862654|O3|Outcome|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
307569|NCT00862654|O2|Outcome|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
307570|NCT00862654|O1|Outcome|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
307571|NCT00862654|E4|Reported Event|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
307572|NCT00862654|E3|Reported Event|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
307573|NCT00862654|E2|Reported Event|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
307574|NCT00862654|E1|Reported Event|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
307575|NCT00862641|B5|Baseline|Total|Total of all reporting groups
307576|NCT00862641|B4|Baseline|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307577|NCT00862641|B3|Baseline|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307578|NCT00862641|B2|Baseline|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307579|NCT00862641|B1|Baseline|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307580|NCT00862641|P4|Participant Flow|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307581|NCT00862641|P3|Participant Flow|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307582|NCT00862641|P2|Participant Flow|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307583|NCT00862641|P1|Participant Flow|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307584|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307585|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307586|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307587|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307588|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307589|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307590|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307591|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307592|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307593|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307594|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307595|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307596|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307597|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307598|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307599|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307600|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307601|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307602|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307603|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307604|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307605|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307606|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307607|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307608|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307609|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307610|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307611|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307612|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307613|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307614|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307615|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307616|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307617|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307618|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307619|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307620|NCT00862641|E4|Reported Event|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307621|NCT00862641|E3|Reported Event|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
307622|NCT00862641|E2|Reported Event|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
307623|NCT00862641|E1|Reported Event|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
307624|NCT00862563|B5|Baseline|Total|Total of all reporting groups
307625|NCT00862563|B4|Baseline|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307626|NCT00862563|B3|Baseline|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307627|NCT00862563|B2|Baseline|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307628|NCT00862563|B1|Baseline|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307629|NCT00862563|P4|Participant Flow|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307630|NCT00862563|P3|Participant Flow|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307631|NCT00862563|P2|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307632|NCT00862563|P1|Participant Flow|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307633|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
307634|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
307635|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
307824|NCT00862277|B2|Baseline|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
316948|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
307636|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
307637|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
307638|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
307639|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
307640|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
307641|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307642|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307643|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307644|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307645|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
307646|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
307647|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
307648|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
307649|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
307650|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
307651|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
307652|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
307653|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307654|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307655|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307656|NCT00862563|O1|Outcome|Zonisamide|Zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307657|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307658|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307659|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307660|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307661|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307662|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307663|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307664|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307665|NCT00862563|E4|Reported Event|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
307666|NCT00862563|E3|Reported Event|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
307667|NCT00862563|E2|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
307668|NCT00862563|E1|Reported Event|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
307669|NCT00862537|B1|Baseline|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
307670|NCT00862537|P1|Participant Flow|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
307671|NCT00862537|O1|Outcome|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
307672|NCT00862537|E1|Reported Event|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
307673|NCT00862459|B4|Baseline|Total|Total of all reporting groups
307674|NCT00862459|B3|Baseline|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307675|NCT00862459|B2|Baseline|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307676|NCT00862459|B1|Baseline|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
307677|NCT00862459|P3|Participant Flow|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307678|NCT00862459|P2|Participant Flow|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307679|NCT00862459|P1|Participant Flow|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
307680|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307681|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307682|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307683|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307684|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307685|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307686|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307687|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307876|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307688|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307689|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307690|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307691|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307692|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307693|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307694|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307695|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307696|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307697|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307698|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307699|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307700|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307701|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307702|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307703|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307704|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307705|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307706|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307707|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307708|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307709|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307710|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307711|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307712|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307713|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307714|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307715|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307716|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307717|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307718|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307719|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307720|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307721|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307722|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307723|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307724|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307725|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307726|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307727|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307728|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307729|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307730|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307731|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307732|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307733|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307734|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307735|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307736|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307737|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307738|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307739|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307740|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307741|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307742|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307743|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307744|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307745|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307746|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307747|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307748|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307749|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307750|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307751|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307752|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307753|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307754|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307755|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307756|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307757|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307758|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307759|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307760|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307761|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307762|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307763|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307764|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307765|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307766|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307767|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307768|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307769|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307770|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307771|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307772|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307773|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307774|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307775|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307776|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307777|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307778|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307779|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307780|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307781|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307782|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307783|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307784|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307785|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307786|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307787|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307788|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307789|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307790|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307791|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307792|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307793|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307794|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307795|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307796|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307797|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307798|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307799|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307800|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307801|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307802|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307803|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307804|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307805|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307806|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307807|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307808|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307809|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307810|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307811|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307812|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307813|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307814|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307815|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307816|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307817|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307818|NCT00862459|E4|Reported Event|Optimark~0.1mmol/kg BW|Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307819|NCT00862459|E3|Reported Event|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307820|NCT00862459|E2|Reported Event|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307821|NCT00862459|E1|Reported Event|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
307822|NCT00862277|B4|Baseline|Total|Total of all reporting groups
307823|NCT00862277|B3|Baseline|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
307825|NCT00862277|B1|Baseline|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
307826|NCT00862277|P3|Participant Flow|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
307827|NCT00862277|P2|Participant Flow|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
307828|NCT00862277|P1|Participant Flow|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
307829|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
307830|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
307831|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
307832|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
307833|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
307834|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
307835|NCT00862277|E3|Reported Event|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
307836|NCT00862277|E2|Reported Event|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
307837|NCT00862277|E1|Reported Event|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
307838|NCT00862251|B4|Baseline|Total|Total of all reporting groups
307839|NCT00862251|B3|Baseline|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307840|NCT00862251|B2|Baseline|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307841|NCT00862251|B1|Baseline|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307842|NCT00862251|P3|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307843|NCT00862251|P2|Participant Flow|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307844|NCT00862251|P1|Participant Flow|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307845|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307846|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307847|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307848|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307849|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307850|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307851|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307852|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307853|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307854|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307855|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307856|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307857|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307858|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307859|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307860|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307861|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307862|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307863|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307864|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307865|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307866|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307867|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307868|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307869|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307870|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307871|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307872|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307873|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307874|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307875|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307877|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307878|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
307879|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307880|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
307881|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307882|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307883|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307884|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307885|NCT00862251|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307886|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307887|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
307888|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307889|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
307890|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307891|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307892|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307893|NCT00862251|E3|Reported Event|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
307894|NCT00862251|E2|Reported Event|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
307895|NCT00862251|E1|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
307896|NCT00862186|B1|Baseline|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
307897|NCT00862186|P1|Participant Flow|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
307898|NCT00862186|O2|Outcome|Resource Helpfulness|Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale.
307899|NCT00862186|O1|Outcome|Resource Use|Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale.
307900|NCT00862186|E1|Reported Event|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
307901|NCT00862134|B3|Baseline|Total|Total of all reporting groups
307902|NCT00862134|B2|Baseline|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
307903|NCT00862134|B1|Baseline|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307904|NCT00862134|P2|Participant Flow|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
307905|NCT00862134|P1|Participant Flow|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307906|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
307907|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307908|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
307909|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307910|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
307911|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307912|NCT00862134|E2|Reported Event|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
307913|NCT00862134|E1|Reported Event|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
307914|NCT00862121|B3|Baseline|Total|Total of all reporting groups
307918|NCT00862121|P1|Participant Flow|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307919|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307920|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307921|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307922|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307923|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307924|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307925|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307926|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307927|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307928|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307929|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307930|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307931|NCT00862121|E2|Reported Event|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307932|NCT00862121|E1|Reported Event|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
307933|NCT00862082|B3|Baseline|Total|Total of all reporting groups
307934|NCT00862082|B2|Baseline|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307935|NCT00862082|B1|Baseline|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307936|NCT00862082|P2|Participant Flow|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307937|NCT00862082|P1|Participant Flow|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307938|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307939|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307940|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307941|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307942|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307943|NCT00862082|O1|Outcome|PR104|
307944|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307945|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307946|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307947|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307948|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307949|NCT00862082|O1|Outcome|PR104|
307950|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307951|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307952|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307953|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307954|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307955|NCT00862082|O1|Outcome|PR104|
307956|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307957|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307958|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307959|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307960|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307961|NCT00862082|O1|Outcome|PR104|
307962|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307963|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307964|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307965|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307966|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307967|NCT00862082|O1|Outcome|PR104|
307968|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
307969|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
307970|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
307971|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
307972|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
307973|NCT00862082|O1|Outcome|PR104|
307974|NCT00862082|O2|Outcome|Cohort 2|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307975|NCT00862082|O1|Outcome|Cohort 1|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307976|NCT00862082|O1|Outcome|Cohorts 1 and 2|770 and 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307977|NCT00862082|E2|Reported Event|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307978|NCT00862082|E1|Reported Event|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
307979|NCT00861913|B1|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307980|NCT00861913|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307981|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307982|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307983|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307984|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307985|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307986|NCT00861913|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
307987|NCT00861757|B5|Baseline|Total|Total of all reporting groups
307988|NCT00861757|B4|Baseline|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
307989|NCT00861757|B3|Baseline|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307990|NCT00861757|B2|Baseline|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307991|NCT00861757|B1|Baseline|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
307992|NCT00861757|P4|Participant Flow|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
307993|NCT00861757|P3|Participant Flow|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307994|NCT00861757|P2|Participant Flow|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307995|NCT00861757|P1|Participant Flow|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
307996|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
307997|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307998|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
307999|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308000|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308001|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308002|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308003|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308004|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308005|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308006|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308007|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308008|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308009|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308010|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308011|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308012|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308013|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308014|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308015|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308016|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308017|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308018|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308019|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308020|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308021|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308022|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308023|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308024|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308025|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308026|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308027|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308028|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308029|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308030|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308031|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308032|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308033|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308034|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308035|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308036|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308037|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308038|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308039|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308040|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
308041|NCT00861757|O3|Outcome|5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
308042|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
308043|NCT00861757|O1|Outcome|Placebo|Drug: Placebo PO, QD (30min after meal) for 12 weeks
308044|NCT00861757|E4|Reported Event|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
308045|NCT00861757|E3|Reported Event|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308046|NCT00861757|E2|Reported Event|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
308047|NCT00861757|E1|Reported Event|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
308048|NCT00861744|B5|Baseline|Total|Total of all reporting groups
308049|NCT00861744|B4|Baseline|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308050|NCT00861744|B3|Baseline|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308051|NCT00861744|B2|Baseline|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308052|NCT00861744|B1|Baseline|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308053|NCT00861744|P4|Participant Flow|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308054|NCT00861744|P3|Participant Flow|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308055|NCT00861744|P2|Participant Flow|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308056|NCT00861744|P1|Participant Flow|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308057|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308058|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308247|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
308555|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308059|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308060|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308061|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308062|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308063|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308064|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308065|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308066|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308067|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308068|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308069|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308070|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308071|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308072|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308073|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308074|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308075|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308076|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308077|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308078|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308079|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308080|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308081|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308082|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308083|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308084|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308085|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308086|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308087|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308088|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308089|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308090|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308091|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308092|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308093|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308094|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308095|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308096|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308097|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308098|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308099|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308100|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308101|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308102|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308103|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308104|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308105|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308106|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308107|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308108|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308109|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308110|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308111|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308112|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308113|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308114|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308115|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308116|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308117|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308118|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308119|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308120|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308121|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308122|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308123|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308124|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308125|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308126|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308127|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308128|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308129|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308130|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308131|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308132|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308133|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308134|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308135|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308136|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308137|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308138|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308139|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308140|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308141|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308142|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308143|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308144|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308145|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308146|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308147|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308148|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308149|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308150|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308151|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308152|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308153|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308154|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308155|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308156|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308157|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308158|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308159|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308160|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308161|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308162|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308163|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308164|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308165|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308166|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308167|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308168|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308169|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308170|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308171|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308172|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308173|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308174|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308175|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308176|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308177|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308178|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308179|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308180|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308181|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308182|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308183|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308184|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308185|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308186|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308187|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308188|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308189|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308190|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308191|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308192|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308193|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308194|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308195|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308196|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308197|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308198|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308199|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308200|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308201|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308202|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308203|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308204|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308205|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308206|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308207|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308208|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308209|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308210|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308211|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308212|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308213|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308214|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308215|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308216|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308217|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308218|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308219|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308220|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308221|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308222|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308223|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308224|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308225|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308226|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308227|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308228|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308229|NCT00861744|E4|Reported Event|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308230|NCT00861744|E3|Reported Event|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308231|NCT00861744|E2|Reported Event|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308232|NCT00861744|E1|Reported Event|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
308233|NCT00861705|B5|Baseline|Total|Total of all reporting groups
308234|NCT00861705|B4|Baseline|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
308235|NCT00861705|B3|Baseline|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
308236|NCT00861705|B2|Baseline|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
308237|NCT00861705|B1|Baseline|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
308238|NCT00861705|P4|Participant Flow|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
308239|NCT00861705|P3|Participant Flow|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
308240|NCT00861705|P2|Participant Flow|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
308241|NCT00861705|P1|Participant Flow|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
308242|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
308243|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
308244|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
308245|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
308246|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
308556|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308248|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
308249|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
308250|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
308251|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
308252|NCT00861705|E4|Reported Event|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|carboplatin: Given IV
308253|NCT00861705|E3|Reported Event|Arm 3 (Pac + Carboplatin --> ddAC)|carboplatin: Given IV
308254|NCT00861705|E2|Reported Event|Arm 2 (Pac + Bev --> ddAC + Bev)|bevacizumab: Given IV
308255|NCT00861705|E1|Reported Event|Arm 1 (Pac --> ddAC)|cyclophosphamide: Given IV
308256|NCT00861692|B1|Baseline|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308257|NCT00861692|P1|Participant Flow|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308258|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308259|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308260|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308261|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308262|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308263|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308264|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308265|NCT00861692|E1|Reported Event|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
308266|NCT00861614|B3|Baseline|Total|Total of all reporting groups
308267|NCT00861614|B2|Baseline|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308268|NCT00861614|B1|Baseline|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308269|NCT00861614|P2|Participant Flow|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308270|NCT00861614|P1|Participant Flow|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308271|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308272|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308273|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308327|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308557|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308558|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308274|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308275|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308276|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308277|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308278|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308279|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308280|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308281|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308282|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308283|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308284|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308285|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308424|NCT00860743|B7|Baseline|Total|Total of all reporting groups
308286|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308287|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308288|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308289|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308290|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308291|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308292|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308293|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308294|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308295|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308296|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308297|NCT00861614|E2|Reported Event|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308559|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308298|NCT00861614|E1|Reported Event|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
308299|NCT00861601|B4|Baseline|Total|Total of all reporting groups
308300|NCT00861601|B3|Baseline|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308301|NCT00861601|B2|Baseline|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308302|NCT00861601|B1|Baseline|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308303|NCT00861601|P3|Participant Flow|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308304|NCT00861601|P2|Participant Flow|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308305|NCT00861601|P1|Participant Flow|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308306|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308307|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308308|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308309|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308310|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308311|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308312|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308313|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308314|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308315|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308316|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308317|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308318|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308319|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308320|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308321|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308322|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308323|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308324|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308325|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308326|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308560|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308328|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308329|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308330|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308331|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308332|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308333|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308334|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308335|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308336|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308337|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308338|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308339|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308340|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308341|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308342|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308343|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308344|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
308345|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308346|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308347|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
308348|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308349|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308350|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308351|NCT00861601|E3|Reported Event|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308352|NCT00861601|E2|Reported Event|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
308353|NCT00861601|E1|Reported Event|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
308354|NCT00861471|B1|Baseline|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308355|NCT00861471|P1|Participant Flow|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308356|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
316949|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
308357|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308358|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308359|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308360|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308361|NCT00861471|E1|Reported Event|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
308362|NCT00861341|B1|Baseline|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
308363|NCT00861341|P1|Participant Flow|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
308364|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
308365|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
308366|NCT00861341|E1|Reported Event|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
308367|NCT00861263|B1|Baseline|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
308368|NCT00861263|P1|Participant Flow|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
308369|NCT00861263|O1|Outcome|Spiral Enteroscopy Subjects|All subjects followed up after spiral enteroscopy
308370|NCT00861263|E1|Reported Event|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
308371|NCT00861198|B1|Baseline|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
308372|NCT00861198|P1|Participant Flow|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
308373|NCT00861198|O1|Outcome|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
308374|NCT00861198|E1|Reported Event|ERCP|"Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.~ERCP as per medical indication: ERCP as per medical indication"
308375|NCT00861146|B3|Baseline|Total|Total of all reporting groups
308376|NCT00861146|B2|Baseline|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308377|NCT00861146|B1|Baseline|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308378|NCT00861146|P2|Participant Flow|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308379|NCT00861146|P1|Participant Flow|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308441|NCT00860535|E1|Reported Event|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care.
308380|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308381|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308382|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308383|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308384|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308385|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308386|NCT00861146|E2|Reported Event|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308387|NCT00861146|E1|Reported Event|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
308388|NCT00860951|B1|Baseline|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
308389|NCT00860951|P1|Participant Flow|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
308390|NCT00860951|O3|Outcome|Assistive Technology Enironment|Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
308391|NCT00860951|O2|Outcome|Computer Environment|Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
308392|NCT00860951|O1|Outcome|BCI Environment|Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
308393|NCT00860951|E1|Reported Event|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
308394|NCT00860847|B3|Baseline|Total|Total of all reporting groups
308395|NCT00860847|B2|Baseline|Placebo|Patients randomized to placebo
308396|NCT00860847|B1|Baseline|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
308397|NCT00860847|P2|Participant Flow|Placebo|Patients randomized to placebo
308398|NCT00860847|P1|Participant Flow|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
308399|NCT00860847|O2|Outcome|Placebo|Patients randomized to placebo
308400|NCT00860847|O1|Outcome|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
308401|NCT00860847|E2|Reported Event|Placebo|Patients randomized to placebo
308402|NCT00860847|E1|Reported Event|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
308403|NCT00860795|B3|Baseline|Total|Total of all reporting groups
308404|NCT00860795|B2|Baseline|Placebo|25 ml daily in 2 divided doses for 10 days
308405|NCT00860795|B1|Baseline|Echinacea|25 ml daily in 2 divided doses for 10 days
308406|NCT00860795|P2|Participant Flow|Placebo|25 ml daily in 2 divided doses for 10 days
308407|NCT00860795|P1|Participant Flow|Echinacea|25 ml daily in 2 divided doses for 10 days
308408|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308409|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308410|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308411|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308412|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308413|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308414|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308415|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308416|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308417|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308418|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308419|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308420|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
308421|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
308422|NCT00860795|E2|Reported Event|Placebo|25 ml daily in 2 divided doses for 10 days
308423|NCT00860795|E1|Reported Event|Echinacea|25 ml daily in 2 divided doses for 10 days
308425|NCT00860743|B6|Baseline|Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo|We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
308426|NCT00860743|B5|Baseline|Aim 2 - OSA - Hypoxia - Antioxidant/Placebo|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
308427|NCT00860743|B4|Baseline|Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308428|NCT00860743|B3|Baseline|Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308429|NCT00860743|B2|Baseline|Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308430|NCT00860743|B1|Baseline|Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308431|NCT00860743|P2|Participant Flow|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
308432|NCT00860743|P1|Participant Flow|OSA/Healthy - Males/Females - Wake/Sleep|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308433|NCT00860743|O1|Outcome|OSA/HEALTHY - HYPOXIA - ANTIOXIDANT/PLACEBO|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
308434|NCT00860743|O1|Outcome|OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308435|NCT00860743|E2|Reported Event|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
308436|NCT00860743|E1|Reported Event|Arm 1|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
308437|NCT00860535|B1|Baseline|Ph+ CML or Ph+ ALL|Growth Factor Signature (GFS) biomarker evaluation in participants with blast phase Ph+ CML or Ph+ ALL who were treated with imatinib, dasatinib or nilotinib as per standard of care.
308438|NCT00860535|P1|Participant Flow|Ph+ CML or Ph+ ALL|Participants with blast phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL) who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
308439|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
308440|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
308443|NCT00860470|B2|Baseline|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308444|NCT00860470|B1|Baseline|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308445|NCT00860470|P2|Participant Flow|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308446|NCT00860470|P1|Participant Flow|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308447|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308448|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308449|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308450|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308451|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308452|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308453|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308454|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308455|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308456|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308457|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308458|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308459|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308460|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308461|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308462|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308463|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308464|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308465|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308466|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308467|NCT00860470|E2|Reported Event|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308468|NCT00860470|E1|Reported Event|Iron (27 mg) and Folic Acid (600 ug)|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
308469|NCT00860457|B1|Baseline|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
308470|NCT00860457|P1|Participant Flow|Chemotherapy|Fludarabine/Rituximab followed by Lenalidomide
308471|NCT00860457|O1|Outcome|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
308472|NCT00860457|E1|Reported Event|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
308473|NCT00860405|B3|Baseline|Total|Total of all reporting groups
308474|NCT00860405|B2|Baseline|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308475|NCT00860405|B1|Baseline|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308476|NCT00860405|P2|Participant Flow|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308477|NCT00860405|P1|Participant Flow|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308478|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308479|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308480|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308481|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308482|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308483|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308484|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308485|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308486|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308487|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308488|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308489|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308490|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308491|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308492|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308493|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308494|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308495|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308496|NCT00860405|E2|Reported Event|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
308497|NCT00860405|E1|Reported Event|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
308498|NCT00860314|B3|Baseline|Total|Total of all reporting groups
308499|NCT00860314|B2|Baseline|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308500|NCT00860314|B1|Baseline|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308501|NCT00860314|P2|Participant Flow|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308502|NCT00860314|P1|Participant Flow|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308503|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308504|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308505|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308506|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308507|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308508|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308509|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308510|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308511|NCT00860314|E2|Reported Event|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
308512|NCT00860314|E1|Reported Event|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
308513|NCT00860262|B4|Baseline|Total|Total of all reporting groups
308514|NCT00860262|B3|Baseline|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308515|NCT00860262|B2|Baseline|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308516|NCT00860262|B1|Baseline|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308517|NCT00860262|P3|Participant Flow|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308518|NCT00860262|P2|Participant Flow|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308519|NCT00860262|P1|Participant Flow|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308520|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308521|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308522|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308523|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308524|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308525|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308526|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308527|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308528|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308529|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308530|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308531|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308532|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308533|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308534|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308535|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308536|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308537|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308538|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308539|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308540|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308541|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308542|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308543|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308544|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308545|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308546|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308547|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308548|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308549|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308550|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308551|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308552|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308553|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308554|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308561|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308562|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308563|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308564|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308565|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308566|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308567|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308568|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308569|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308570|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308571|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308572|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308573|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308574|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308575|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308576|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308577|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308578|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308579|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308580|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308581|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308582|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308583|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308584|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308585|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308586|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308587|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308588|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308589|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308590|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308591|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308592|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308593|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308594|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308595|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308596|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308597|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308598|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308599|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308600|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308601|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308602|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308603|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308604|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308605|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308606|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308607|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308608|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308609|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308610|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308611|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308612|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308613|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
308614|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308615|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
308616|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308617|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308618|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308619|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308620|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308621|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308622|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308623|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308624|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308625|NCT00860262|E3|Reported Event|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
308626|NCT00860262|E2|Reported Event|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
308627|NCT00860262|E1|Reported Event|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
308628|NCT00860249|B4|Baseline|Total|Total of all reporting groups
308667|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308751|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308629|NCT00860249|B3|Baseline|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
308630|NCT00860249|B2|Baseline|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
308631|NCT00860249|B1|Baseline|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
308632|NCT00860249|P3|Participant Flow|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
308633|NCT00860249|P2|Participant Flow|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
308634|NCT00860249|P1|Participant Flow|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
308635|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
308636|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
308637|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
308638|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
308639|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
308640|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
308641|NCT00860249|E3|Reported Event|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
308642|NCT00860249|E2|Reported Event|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
308643|NCT00860249|E1|Reported Event|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
308644|NCT00860158|B1|Baseline|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308645|NCT00860158|P1|Participant Flow|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308646|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308647|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308648|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308720|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date
308752|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308649|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308650|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308651|NCT00860158|E1|Reported Event|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
308652|NCT00860067|B4|Baseline|Total|Total of all reporting groups
308653|NCT00860067|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308654|NCT00860067|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308655|NCT00860067|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308656|NCT00860067|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308657|NCT00860067|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308658|NCT00860067|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308659|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308660|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308661|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308662|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308663|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308664|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308665|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308666|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308668|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308669|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308670|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308671|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308672|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308673|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308674|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308675|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308676|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308677|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308678|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308679|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308680|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308681|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308682|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308683|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308750|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308684|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308685|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308686|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308687|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308688|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308689|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308690|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308691|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308692|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308693|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308694|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308695|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308696|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308697|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308698|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308699|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308700|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308701|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308702|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308703|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308704|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308705|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308706|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308707|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308708|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308709|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308710|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
308711|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
308712|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308713|NCT00860067|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
308714|NCT00860067|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
308715|NCT00860028|B3|Baseline|Total|Total of all reporting groups
308716|NCT00860028|B2|Baseline|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
308717|NCT00860028|B1|Baseline|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
308718|NCT00860028|P2|Participant Flow|Placebo Pretreatment/Varenicline Treatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
308719|NCT00860028|P1|Participant Flow|Varenicline Pretreatment/Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
309430|NCT00857649|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
308721|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
308722|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
308723|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date.
308724|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
308725|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
308726|NCT00860028|E2|Reported Event|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
308727|NCT00860028|E1|Reported Event|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
308728|NCT00859937|B3|Baseline|Total|Total of all reporting groups
308729|NCT00859937|B2|Baseline|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308730|NCT00859937|B1|Baseline|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308731|NCT00859937|P2|Participant Flow|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308732|NCT00859937|P1|Participant Flow|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308733|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308734|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308735|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308736|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308737|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308738|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308739|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308740|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308741|NCT00859937|E2|Reported Event|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308742|NCT00859937|E1|Reported Event|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
308743|NCT00859898|B4|Baseline|Total|Total of all reporting groups
308744|NCT00859898|B3|Baseline|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308745|NCT00859898|B2|Baseline|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308746|NCT00859898|B1|Baseline|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308747|NCT00859898|P3|Participant Flow|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308748|NCT00859898|P2|Participant Flow|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.~Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks."
308749|NCT00859898|P1|Participant Flow|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
309213|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
308753|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308754|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308755|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308756|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308757|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308758|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308759|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308760|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308761|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308762|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308763|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308764|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308765|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308766|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308767|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308768|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308769|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308770|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308771|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308772|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308773|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308774|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308775|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308776|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308777|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308778|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
308779|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308780|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308781|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308782|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308783|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308784|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308785|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308786|NCT00859898|E3|Reported Event|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
308787|NCT00859898|E2|Reported Event|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
308788|NCT00859898|E1|Reported Event|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
308789|NCT00859833|B1|Baseline|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
309431|NCT00857623|B3|Baseline|Total|Total of all reporting groups
308790|NCT00859833|P1|Participant Flow|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
308791|NCT00859833|O2|Outcome|Regadenoson|Regadenoson 0.5 mg i.v. bolus.
308792|NCT00859833|O1|Outcome|Adenosine|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
308793|NCT00859833|E1|Reported Event|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
308794|NCT00859638|B3|Baseline|Total|Total of all reporting groups
308795|NCT00859638|B2|Baseline|Case Matched Controls|Usual care in primary health care.
308796|NCT00859638|B1|Baseline|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
308797|NCT00859638|P2|Participant Flow|Case Matched Controls|Usual care in primary health care.
308798|NCT00859638|P1|Participant Flow|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
308799|NCT00859638|O2|Outcome|Case Matched Controls|Usual care in primary health care.
308800|NCT00859638|O1|Outcome|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
308801|NCT00859638|E2|Reported Event|Case Matched Controls|Usual care in primary health care.
308802|NCT00859638|E1|Reported Event|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
308803|NCT00859586|B1|Baseline|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
308804|NCT00859586|P1|Participant Flow|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
308805|NCT00859586|O1|Outcome|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
308806|NCT00859586|E1|Reported Event|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
308807|NCT00859573|B3|Baseline|Total|Total of all reporting groups
308808|NCT00859573|B2|Baseline|Placebo|Two placebo tablets orally once daily
308809|NCT00859573|B1|Baseline|Modafinil|Modafinil 400mg orally once daily
308810|NCT00859573|P2|Participant Flow|Placebo|Two placebo tablets orally once daily
308811|NCT00859573|P1|Participant Flow|Modafinil|Modafinil 400mg orally once daily
308812|NCT00859573|O2|Outcome|Modafinil|Modafinil 400mg orally daily
308813|NCT00859573|O1|Outcome|Placebo|Participants received 2 capsules placebo orally daily
308814|NCT00859573|E2|Reported Event|Placebo|Two placebo tablets orally once daily
308815|NCT00859573|E1|Reported Event|Modafinil|Modafinil 400mg orally once daily
308816|NCT00859547|B1|Baseline|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308817|NCT00859547|P1|Participant Flow|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308818|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308819|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308820|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308821|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308822|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308823|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308824|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308825|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
308826|NCT00859547|E1|Reported Event|TOTAL|
308827|NCT00859521|B3|Baseline|Total|Total of all reporting groups
308828|NCT00859521|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
308829|NCT00859521|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
308830|NCT00859521|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
308831|NCT00859521|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
308832|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308833|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308834|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308835|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308836|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308837|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308838|NCT00859508|B3|Baseline|Total|Total of all reporting groups
308839|NCT00859508|B2|Baseline|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
308840|NCT00859508|B1|Baseline|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
308841|NCT00859508|P2|Participant Flow|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
308842|NCT00859508|P1|Participant Flow|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
308843|NCT00859508|O2|Outcome|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
308844|NCT00859508|O1|Outcome|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
308845|NCT00859508|E2|Reported Event|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
308846|NCT00859508|E1|Reported Event|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
308847|NCT00859469|B1|Baseline|Oxaliplatin and Gemcitabine|
308848|NCT00859469|P1|Participant Flow|Oxaliplatin and Gemcitabine|
308849|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
308850|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
308851|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
308852|NCT00859469|E1|Reported Event|Oxaliplatin and Gemcitabine|
308853|NCT00859430|B3|Baseline|Total|Total of all reporting groups
308854|NCT00859430|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
308855|NCT00859430|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
308856|NCT00859430|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
308857|NCT00859430|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
308858|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308859|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308860|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308861|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308862|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
308863|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
308864|NCT00859339|B1|Baseline|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308865|NCT00859339|P1|Participant Flow|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308866|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308867|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308868|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308869|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308870|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308871|NCT00859339|E1|Reported Event|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
308872|NCT00859313|B1|Baseline|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
308873|NCT00859313|P1|Participant Flow|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
308874|NCT00859313|O1|Outcome|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
308875|NCT00859313|E1|Reported Event|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
308876|NCT00859222|B4|Baseline|Total|Total of all reporting groups
308877|NCT00859222|B3|Baseline|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308878|NCT00859222|B2|Baseline|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308879|NCT00859222|B1|Baseline|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
308880|NCT00859222|P5|Participant Flow|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308881|NCT00859222|P4|Participant Flow|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308882|NCT00859222|P3|Participant Flow|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308883|NCT00859222|P2|Participant Flow|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308884|NCT00859222|P1|Participant Flow|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
308885|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
308886|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308887|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
309432|NCT00857623|B2|Baseline|Placebo|Capsule, once daily
308888|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
308889|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
308890|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308891|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308892|NCT00859222|O5|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308893|NCT00859222|O4|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308894|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308895|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308896|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
308897|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308898|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308899|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308900|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308901|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
308902|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
308903|NCT00859222|E5|Reported Event|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308904|NCT00859222|E4|Reported Event|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308905|NCT00859222|E3|Reported Event|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308940|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
309643|NCT00856986|B6|Baseline|Total|Total of all reporting groups
308906|NCT00859222|E2|Reported Event|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
308907|NCT00859222|E1|Reported Event|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
308908|NCT00859131|B3|Baseline|Total|Total of all reporting groups
308909|NCT00859131|B2|Baseline|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308910|NCT00859131|B1|Baseline|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308911|NCT00859131|P2|Participant Flow|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308912|NCT00859131|P1|Participant Flow|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308913|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308914|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308915|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308916|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308917|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308918|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308919|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308920|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308921|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308922|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308923|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308924|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308925|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308926|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308927|NCT00859131|E2|Reported Event|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
308928|NCT00859131|E1|Reported Event|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
308929|NCT00859053|B5|Baseline|Total|Total of all reporting groups
308930|NCT00859053|B4|Baseline|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308931|NCT00859053|B3|Baseline|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308932|NCT00859053|B2|Baseline|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308933|NCT00859053|B1|Baseline|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308934|NCT00859053|P4|Participant Flow|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308935|NCT00859053|P3|Participant Flow|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308936|NCT00859053|P2|Participant Flow|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308937|NCT00859053|P1|Participant Flow|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308938|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308939|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
316950|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
308941|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308942|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308943|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308944|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308945|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308946|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308947|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308948|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308949|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308950|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308951|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308952|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308953|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308954|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308955|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308956|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308957|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308958|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308959|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308960|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308961|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308962|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308963|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308964|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308965|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308966|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308967|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308968|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308969|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308970|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308971|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308972|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308973|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308974|NCT00859053|E4|Reported Event|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
309151|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
308975|NCT00859053|E3|Reported Event|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308976|NCT00859053|E2|Reported Event|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308977|NCT00859053|E1|Reported Event|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
308978|NCT00859040|B3|Baseline|Total|Total of all reporting groups
308979|NCT00859040|B2|Baseline|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308980|NCT00859040|B1|Baseline|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308981|NCT00859040|P2|Participant Flow|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308982|NCT00859040|P1|Participant Flow|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308983|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308984|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308985|NCT00859040|O1|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
308986|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308987|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308988|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308989|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308990|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308991|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
308992|NCT00859040|E1|Reported Event|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
308993|NCT00859027|B3|Baseline|Total|Total of all reporting groups
308994|NCT00859027|B2|Baseline|Calcium and Vitamin D|
308995|NCT00859027|B1|Baseline|Risedronate Plus Calcium and Vit D|
308996|NCT00859027|P2|Participant Flow|Calcium and Vitamin D Daily (Placebo Group)|
308997|NCT00859027|P1|Participant Flow|Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily|
308998|NCT00859027|O2|Outcome|Calcium and Vitamin D-Spine|
308999|NCT00859027|O1|Outcome|Risedronate - Spine|
309000|NCT00859027|E2|Reported Event|Risedronate|Particiapnts given 35 mg by mouth every week
309001|NCT00859027|E1|Reported Event|CAlcium and Vitamin D|
309002|NCT00859014|B1|Baseline|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
309003|NCT00859014|P1|Participant Flow|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
309004|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
309005|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
309006|NCT00859014|E1|Reported Event|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
309007|NCT00858962|B1|Baseline|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
309211|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309008|NCT00858962|P1|Participant Flow|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
309009|NCT00858962|O1|Outcome|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
309010|NCT00858962|E1|Reported Event|Bup/Ral|HIV negative subjects currently enrolled in Buprenorphine maintenance therapy on a stable dose of BUP for at least 3 weeks were admitted to the HRU for PK sampling at intervals over a 24 hour period. Subjects then received RAL and BUP co-administration for a minimum of 4 days after which a second series of blood draws at intervals over a 24 hour period were conducted.
309011|NCT00858858|B1|Baseline|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
309012|NCT00858858|P1|Participant Flow|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
309013|NCT00858858|O1|Outcome|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
309014|NCT00858858|E1|Reported Event|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
309015|NCT00858845|B1|Baseline|Clonidine Patch|Participants will wear a clonidine patch.
309016|NCT00858845|P1|Participant Flow|Clonidine Patch|Participants will wear a clonidine patch.
309017|NCT00858845|O1|Outcome|Clonidine Patch|Participants will wear a clonidine patch.
309018|NCT00858845|E1|Reported Event|Clonidine Patch|Participants will wear a clonidine patch.
309019|NCT00858832|B3|Baseline|Total|Total of all reporting groups
309020|NCT00858832|B2|Baseline|No Methergine|
309021|NCT00858832|B1|Baseline|Methergine|
309022|NCT00858832|P2|Participant Flow|No Treatment|Participants received no intervention (no treatment).
309023|NCT00858832|P1|Participant Flow|Methergine|Participants received Methergine 0.2mg orally every 6 hours for 2 days
309024|NCT00858832|O2|Outcome|No Methergine|
309025|NCT00858832|O1|Outcome|Methergine|
309026|NCT00858832|E2|Reported Event|No Methergine|
309027|NCT00858832|E1|Reported Event|Methergine|
309028|NCT00858780|B1|Baseline|Entire Study Population|Includes all participants who were enrolled in this study.
309029|NCT00858780|P5|Participant Flow|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
309030|NCT00858780|P4|Participant Flow|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309031|NCT00858780|P3|Participant Flow|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309212|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309032|NCT00858780|P2|Participant Flow|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309033|NCT00858780|P1|Participant Flow|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
309034|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309035|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309036|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309037|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309038|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309039|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309040|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309041|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309042|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309043|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309044|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309045|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309046|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309047|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309048|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309049|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309050|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309051|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309052|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309053|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309054|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309055|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309056|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309057|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309058|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309059|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309060|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309061|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309062|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309063|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309064|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309065|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309066|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309067|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309068|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309069|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309070|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309071|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309072|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309073|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309074|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309075|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309076|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309077|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309078|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309079|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309080|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309081|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309082|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309083|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309084|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309085|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309086|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309087|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309088|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309089|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309090|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309091|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309092|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309093|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309094|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309095|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309096|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309097|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309098|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309099|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309100|NCT00858780|E5|Reported Event|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
309101|NCT00858780|E4|Reported Event|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309102|NCT00858780|E3|Reported Event|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
309103|NCT00858780|E2|Reported Event|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
309104|NCT00858780|E1|Reported Event|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
309105|NCT00858702|B3|Baseline|Total|Total of all reporting groups
309106|NCT00858702|B2|Baseline|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
309107|NCT00858702|B1|Baseline|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
309108|NCT00858702|P2|Participant Flow|Olmesartan Medoxomil Tablets and a Diuretic Tablet|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
309109|NCT00858702|P1|Participant Flow|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
309110|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
309111|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
309112|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
309113|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
309114|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
309115|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
309116|NCT00858702|E2|Reported Event|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
309117|NCT00858702|E1|Reported Event|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
309118|NCT00858689|B1|Baseline|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
309119|NCT00858689|P1|Participant Flow|Minocyline 50 mg or 100 mg PO BID|open label, single arm study of minocyline 50 mg or 100 mg PO BID
309120|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
309121|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
309122|NCT00858689|E1|Reported Event|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
309123|NCT00858637|B3|Baseline|Total|Total of all reporting groups
309124|NCT00858637|B2|Baseline|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
309125|NCT00858637|B1|Baseline|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
309126|NCT00858637|P6|Participant Flow|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309127|NCT00858637|P5|Participant Flow|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309128|NCT00858637|P4|Participant Flow|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
309129|NCT00858637|P3|Participant Flow|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309130|NCT00858637|P2|Participant Flow|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309131|NCT00858637|P1|Participant Flow|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
309132|NCT00858637|O2|Outcome|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mgof Simvastatin / day as titrated
309133|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
309134|NCT00858637|O4|Outcome|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309135|NCT00858637|O3|Outcome|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309136|NCT00858637|O2|Outcome|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309137|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
309138|NCT00858637|E2|Reported Event|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
309139|NCT00858637|E1|Reported Event|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
309140|NCT00858507|B3|Baseline|Total|Total of all reporting groups
309141|NCT00858507|B2|Baseline|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
309142|NCT00858507|B1|Baseline|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
309143|NCT00858507|P2|Participant Flow|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
309144|NCT00858507|P1|Participant Flow|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
309145|NCT00858507|O2|Outcome|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
309146|NCT00858507|O1|Outcome|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
309147|NCT00858507|E2|Reported Event|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
309148|NCT00858507|E1|Reported Event|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
309149|NCT00858494|B1|Baseline|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
309150|NCT00858494|P1|Participant Flow|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
316951|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309152|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
309153|NCT00858494|E1|Reported Event|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
309154|NCT00858468|B3|Baseline|Total|Total of all reporting groups
309155|NCT00858468|B2|Baseline|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309156|NCT00858468|B1|Baseline|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309157|NCT00858468|P2|Participant Flow|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309158|NCT00858468|P1|Participant Flow|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309159|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309160|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309161|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309162|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309163|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309164|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309165|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309166|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309167|NCT00858468|E2|Reported Event|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
309168|NCT00858468|E1|Reported Event|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
309169|NCT00858442|B3|Baseline|Total|Total of all reporting groups
309170|NCT00858442|B2|Baseline|With PRP|Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.
309171|NCT00858442|B1|Baseline|Without PRP|Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.
309172|NCT00858442|P2|Participant Flow|With PRP|4 cc of PRP is evenly distributed before the dermo-epidermic draft.
309173|NCT00858442|P1|Participant Flow|Without PRP|This arm did not receive any intervention
309174|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
309175|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
309176|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
309177|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
309178|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
309179|NCT00858442|O1|Outcome|Without PRP|Patients did not received plasma enrich platelets
309180|NCT00858442|E2|Reported Event|With PRP|Patients received plasma enriched platelets
309181|NCT00858442|E1|Reported Event|Without PRP|Patients did not receive plasma enriched platelets
309182|NCT00858403|B1|Baseline|Treatment With Dasatinib|
309183|NCT00858403|P1|Participant Flow|Treatment With Dasatinib|
309184|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309185|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309186|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309187|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309188|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309189|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309190|NCT00858403|O1|Outcome|Treatment With Dasatinib|
309191|NCT00858403|E1|Reported Event|Treatment With Dasatinib|
309192|NCT00858390|B3|Baseline|Total|Total of all reporting groups
309193|NCT00858390|B2|Baseline|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
309194|NCT00858390|B1|Baseline|1 Standard Care|18 organ donors receiving standard care
309195|NCT00858390|P2|Participant Flow|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
309196|NCT00858390|P1|Participant Flow|1 Standard Care|18 organ donors receiving standard care
309197|NCT00858390|O2|Outcome|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
309198|NCT00858390|O1|Outcome|1 Standard Care|18 organ donors receiving standard care
309199|NCT00858390|E2|Reported Event|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
309200|NCT00858390|E1|Reported Event|1 Standard Care|18 organ donors receiving standard care
309201|NCT00858247|B3|Baseline|Total|Total of all reporting groups
309202|NCT00858247|B2|Baseline|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily
309203|NCT00858247|B1|Baseline|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily
309204|NCT00858247|P2|Participant Flow|Vitamin D3-high Dose|"Vitamin D3 2000 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
309205|NCT00858247|P1|Participant Flow|Vitamin D3-low Dose|"Vitamin D3 400 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
309206|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309207|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309208|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309209|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309210|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
316952|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
309214|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309215|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309216|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309217|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309218|NCT00858247|E2|Reported Event|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
309219|NCT00858247|E1|Reported Event|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
309220|NCT00858208|B1|Baseline|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309221|NCT00858208|P1|Participant Flow|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309222|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309223|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309224|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309225|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309226|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309227|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309228|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309229|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309230|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309231|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309232|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309233|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309234|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309235|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309236|NCT00858208|E1|Reported Event|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
309237|NCT00858143|B1|Baseline|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309238|NCT00858143|P1|Participant Flow|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309239|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309240|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309241|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309242|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309243|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309244|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309245|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309246|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309247|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309248|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
316953|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309249|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309250|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309251|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309252|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309253|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309254|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309255|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309256|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309257|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309258|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309259|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309260|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309261|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309262|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309263|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309264|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309265|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309266|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309267|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309268|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309269|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309270|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309271|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309272|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309273|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309274|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309275|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309276|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309277|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309278|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309279|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309280|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309281|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309282|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309283|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309284|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309285|NCT00858143|E1|Reported Event|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
309286|NCT00857961|B1|Baseline|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
309287|NCT00857961|P1|Participant Flow|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
309288|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309289|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309290|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309291|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309292|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309293|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309294|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309295|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309296|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309418|NCT00857649|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
309297|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309298|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309299|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309300|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309301|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309302|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309303|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309304|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309305|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309306|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309307|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309308|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309309|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309310|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309311|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309312|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309313|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309314|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309315|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309316|NCT00857961|E4|Reported Event|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
309317|NCT00857961|E3|Reported Event|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309318|NCT00857961|E2|Reported Event|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
309319|NCT00857961|E1|Reported Event|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
309320|NCT00857948|B5|Baseline|Total|Total of all reporting groups
309321|NCT00857948|B4|Baseline|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309322|NCT00857948|B3|Baseline|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309323|NCT00857948|B2|Baseline|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309324|NCT00857948|B1|Baseline|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309325|NCT00857948|P4|Participant Flow|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309326|NCT00857948|P3|Participant Flow|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309327|NCT00857948|P2|Participant Flow|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309328|NCT00857948|P1|Participant Flow|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309329|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309330|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309331|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309332|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309333|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309334|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309335|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309336|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309337|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309338|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309339|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309340|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309341|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309342|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309343|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309344|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309345|NCT00857948|E4|Reported Event|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
309346|NCT00857948|E3|Reported Event|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
309347|NCT00857948|E2|Reported Event|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
309348|NCT00857948|E1|Reported Event|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
309349|NCT00857896|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309350|NCT00857896|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309351|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309352|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309353|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309354|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309355|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309356|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309357|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309358|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
309359|NCT00857896|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 8 mg tablet QD anytime during the study
309360|NCT00857896|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet QD anytime during the study
309361|NCT00857818|B3|Baseline|Total|Total of all reporting groups
309362|NCT00857818|B2|Baseline|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309363|NCT00857818|B1|Baseline|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309364|NCT00857818|P2|Participant Flow|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309365|NCT00857818|P1|Participant Flow|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309366|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309367|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309368|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309369|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309370|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309371|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309372|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309373|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309374|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309375|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309376|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309377|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309378|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309379|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309380|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309381|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309382|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309383|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309384|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309385|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309386|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309387|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309388|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309389|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309390|NCT00857818|E2|Reported Event|CONTROL GROUP|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
309391|NCT00857818|E1|Reported Event|ARIPIPRAZOLE|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
309392|NCT00857792|B1|Baseline|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
309393|NCT00857792|P1|Participant Flow|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
309394|NCT00857792|O1|Outcome|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
309395|NCT00857792|E1|Reported Event|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
309396|NCT00857766|B3|Baseline|Total|Total of all reporting groups
309397|NCT00857766|B2|Baseline|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309398|NCT00857766|B1|Baseline|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309399|NCT00857766|P2|Participant Flow|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309400|NCT00857766|P1|Participant Flow|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309401|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309402|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309403|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309404|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309405|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309406|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309407|NCT00857766|E2|Reported Event|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309408|NCT00857766|E1|Reported Event|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
309409|NCT00857714|B1|Baseline|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
309410|NCT00857714|P1|Participant Flow|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
309411|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
309412|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
309413|NCT00857714|E1|Reported Event|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
309414|NCT00857649|B3|Baseline|Total|Total of all reporting groups
309415|NCT00857649|B2|Baseline|Placebo|Oral Tablets Once Daily
309416|NCT00857649|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
309417|NCT00857649|P2|Participant Flow|Placebo|Oral Tablets Once Daily
309433|NCT00857623|B1|Baseline|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309434|NCT00857623|P2|Participant Flow|Placebo|Capsule, once daily
309435|NCT00857623|P1|Participant Flow|AZD2066|Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
309436|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309437|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309438|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309439|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309440|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309441|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309442|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309443|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309444|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309445|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309446|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309447|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309448|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309449|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309450|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309451|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309452|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
309453|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309454|NCT00857623|E2|Reported Event|Placebo|Capsule, once daily
309455|NCT00857623|E1|Reported Event|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
309456|NCT00857584|B3|Baseline|Total|Total of all reporting groups
309457|NCT00857584|B2|Baseline|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309458|NCT00857584|B1|Baseline|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309459|NCT00857584|P2|Participant Flow|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309460|NCT00857584|P1|Participant Flow|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309461|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309462|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309463|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309464|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309465|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309466|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309467|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309468|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309469|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309470|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309471|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309472|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309473|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309474|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309475|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309476|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309477|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309478|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309479|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309480|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309481|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309482|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309483|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309484|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309485|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309486|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309487|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309488|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309489|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309490|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309491|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309492|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309493|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309494|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309495|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309496|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309497|NCT00857584|E2|Reported Event|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
309498|NCT00857584|E1|Reported Event|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
309499|NCT00857532|B1|Baseline|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
309500|NCT00857532|P1|Participant Flow|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
309501|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
309502|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
309503|NCT00857532|O3|Outcome|Subjects With Moderate to Severe Cognitive Impairment|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.
309504|NCT00857532|O2|Outcome|Subjects With Mild Cognitive Deficits|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.
309505|NCT00857532|O1|Outcome|Subjects With Normal Cognitive Performance|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.
309506|NCT00857532|E1|Reported Event|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
309507|NCT00857506|B4|Baseline|Total|Total of all reporting groups
309508|NCT00857506|B3|Baseline|Cognitively Normal|
309509|NCT00857506|B2|Baseline|Mild Cognitive Impairment|
309510|NCT00857506|B1|Baseline|Alzheimer's Disease|
309511|NCT00857506|P3|Participant Flow|Cognitively Normal|Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
309512|NCT00857506|P2|Participant Flow|Mild Cognitive Impairment|Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
309513|NCT00857506|P1|Participant Flow|Alzheimer's Disease|Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
309514|NCT00857506|O3|Outcome|Cognitively Normal|Subjects with a baseline clinical diagnosis of CN.
309515|NCT00857506|O2|Outcome|Mild Cognitive Impairment|Subjects with a baseline clinical diagnosis of MCI.
309516|NCT00857506|O1|Outcome|Alzheimer's Disease|Subjects with a baseline clinical diagnosis of AD.
309517|NCT00857506|O6|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
309518|NCT00857506|O5|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
309519|NCT00857506|O4|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
309520|NCT00857506|O3|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
309521|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.
309522|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
309523|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
309524|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
309525|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.
309526|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
309527|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
309528|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
309529|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline.
309530|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
309531|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
309532|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
309533|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
309534|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
309535|NCT00857506|E3|Reported Event|Cognitively Normal|
309536|NCT00857506|E2|Reported Event|Mild Cognitive Impairment|
309537|NCT00857506|E1|Reported Event|Alzheimer's Disease|
309538|NCT00857454|B1|Baseline|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309539|NCT00857454|P1|Participant Flow|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309540|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309541|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309542|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309543|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309544|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309545|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309546|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309547|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309548|NCT00857454|E1|Reported Event|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
309549|NCT00857415|B3|Baseline|Total|Total of all reporting groups
309550|NCT00857415|B2|Baseline|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309551|NCT00857415|B1|Baseline|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309552|NCT00857415|P2|Participant Flow|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309553|NCT00857415|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309554|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
309555|NCT00857415|O1|Outcome|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques
309556|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
309557|NCT00857415|E2|Reported Event|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309558|NCT00857415|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
309559|NCT00857311|B5|Baseline|Total|Total of all reporting groups
309560|NCT00857311|B4|Baseline|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
309561|NCT00857311|B3|Baseline|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309562|NCT00857311|B2|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
309842|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309563|NCT00857311|B1|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309564|NCT00857311|P4|Participant Flow|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
309565|NCT00857311|P3|Participant Flow|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309566|NCT00857311|P2|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
309567|NCT00857311|P1|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309568|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309569|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309570|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309571|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309572|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309573|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309574|NCT00857311|E2|Reported Event|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
309575|NCT00857311|E1|Reported Event|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
309576|NCT00857285|B3|Baseline|Total|Total of all reporting groups
309577|NCT00857285|B2|Baseline|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
309578|NCT00857285|B1|Baseline|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
309579|NCT00857285|P2|Participant Flow|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
309580|NCT00857285|P1|Participant Flow|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
309581|NCT00857285|O2|Outcome|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
309582|NCT00857285|O1|Outcome|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
309583|NCT00857272|B3|Baseline|Total|Total of all reporting groups
309584|NCT00857272|B2|Baseline|HalfLytely With 10mg Bisacodyl|Active Control
309585|NCT00857272|B1|Baseline|HalfLytely With 5mg Bisacodyl|Investigational dose
309586|NCT00857272|P2|Participant Flow|HalfLytely With 10mg Bisacodyl|Active Control
309587|NCT00857272|P1|Participant Flow|HalfLytely With 5mg Bisacodyl|Investigational dose
309588|NCT00857272|O2|Outcome|HalfLytely With 10mg Bisacodyl|Active Control
309589|NCT00857272|O1|Outcome|HalfLytely With 5mg Bisacodyl|Investigational dose
309590|NCT00857272|E2|Reported Event|HalfLytely With 10mg Bisacodyl|Active Control
309591|NCT00857272|E1|Reported Event|HalfLytely With 5mg Bisacodyl|Investigational dose
309592|NCT00857259|B4|Baseline|Total|Total of all reporting groups
309593|NCT00857259|B3|Baseline|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
309594|NCT00857259|B2|Baseline|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
309595|NCT00857259|B1|Baseline|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
309596|NCT00857259|P3|Participant Flow|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
309597|NCT00857259|P2|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
309598|NCT00857259|P1|Participant Flow|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
309599|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
309600|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (Baseline)
309601|NCT00857259|O1|Outcome|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
309602|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
309603|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy 0.5 mg on Day 1 (baseline)
309604|NCT00857259|O1|Outcome|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
309605|NCT00857259|E2|Reported Event|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
309606|NCT00857259|E1|Reported Event|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
309607|NCT00857246|B1|Baseline|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309843|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309608|NCT00857246|P1|Participant Flow|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309609|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309610|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309611|NCT00857246|O1|Outcome|Induction Treatment|Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
309612|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309613|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309614|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment ( starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309615|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309616|NCT00857246|E1|Reported Event|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
309617|NCT00857233|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
309618|NCT00857233|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
309619|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309620|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309621|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309622|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309623|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309624|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
309625|NCT00857233|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
309626|NCT00857220|B1|Baseline|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309627|NCT00857220|P1|Participant Flow|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309628|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309629|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309630|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309631|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309632|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309633|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309634|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309635|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309636|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309637|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309638|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309639|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309640|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309641|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309642|NCT00857220|E1|Reported Event|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
309644|NCT00856986|B5|Baseline|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309645|NCT00856986|B4|Baseline|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309646|NCT00856986|B3|Baseline|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309647|NCT00856986|B2|Baseline|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309648|NCT00856986|B1|Baseline|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309649|NCT00856986|P5|Participant Flow|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309650|NCT00856986|P4|Participant Flow|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309651|NCT00856986|P3|Participant Flow|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309652|NCT00856986|P2|Participant Flow|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309653|NCT00856986|P1|Participant Flow|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309654|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309655|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309656|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309657|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309658|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309659|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309660|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309661|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309662|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309663|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309664|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309665|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309666|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309667|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309668|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309669|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309670|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309671|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309672|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309673|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309674|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309844|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309845|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
316954|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
309675|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309676|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309677|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309678|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309679|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309680|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309681|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309682|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309683|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309684|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309685|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309686|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309687|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309688|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309689|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309846|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309847|NCT00856973|O3|Outcome|Placebo|Placebo once daily
316955|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309690|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309691|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309692|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309693|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309694|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309695|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309696|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309697|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309698|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309699|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309700|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309701|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309702|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309703|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309704|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309848|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily
309849|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily
309705|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309706|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309707|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309708|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309709|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309710|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309711|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309712|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309713|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309714|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309715|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309716|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309717|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309718|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309719|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309850|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309851|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
316956|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
309720|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309721|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309722|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309723|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309724|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309725|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309726|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309727|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309728|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309729|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309730|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309731|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309732|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309733|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309734|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309852|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309853|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
316957|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309735|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309736|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309737|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309738|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309739|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309740|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309741|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309742|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309743|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309744|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309745|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309746|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309747|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309748|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309749|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309854|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309855|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309750|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309751|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309752|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309753|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309754|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309755|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309756|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309757|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309758|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309759|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309760|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309761|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309762|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309763|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309764|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309856|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309857|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
316958|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
309765|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309766|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309767|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309768|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309769|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309770|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309771|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309772|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309773|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309774|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309775|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309776|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309777|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309778|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309779|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309858|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309859|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
316959|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309780|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309781|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309782|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309783|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309784|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309785|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309786|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309787|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309788|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309789|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309790|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309791|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309792|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309793|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309794|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309860|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309861|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309795|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309796|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309797|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309798|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309799|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309800|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309801|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309802|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309803|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309804|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309805|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309806|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309807|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309808|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309809|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309862|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309863|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
316960|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
309810|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309811|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309812|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309813|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309814|NCT00856986|E5|Reported Event|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
309815|NCT00856986|E4|Reported Event|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
309816|NCT00856986|E3|Reported Event|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
309817|NCT00856986|E2|Reported Event|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309818|NCT00856986|E1|Reported Event|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
309819|NCT00856973|B4|Baseline|Total|Total of all reporting groups
309820|NCT00856973|B3|Baseline|Placebo|Placebo Once Daily. This included only patients that were randomized (ITT population).
309821|NCT00856973|B2|Baseline|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
309822|NCT00856973|B1|Baseline|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
309823|NCT00856973|P3|Participant Flow|Placebo|Placebo 6-17 years
309824|NCT00856973|P2|Participant Flow|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309825|NCT00856973|P1|Participant Flow|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309826|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309827|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309828|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309829|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309830|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309831|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309832|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309833|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309834|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309835|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309836|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309837|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309838|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309839|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309840|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309841|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309864|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309865|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309866|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309867|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309868|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309869|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309870|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309871|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309872|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309873|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309874|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309875|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309876|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309877|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309878|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309879|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309880|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
309881|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309882|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309883|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years
309884|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309885|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309886|NCT00856973|E3|Reported Event|Placebo|Placebo 6-17 years once daily
309887|NCT00856973|E2|Reported Event|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
309888|NCT00856973|E1|Reported Event|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
309889|NCT00856934|B4|Baseline|Total|Total of all reporting groups
309890|NCT00856934|B3|Baseline|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309891|NCT00856934|B2|Baseline|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309892|NCT00856934|B1|Baseline|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
309893|NCT00856934|P3|Participant Flow|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309894|NCT00856934|P2|Participant Flow|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309895|NCT00856934|P1|Participant Flow|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
309896|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309897|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309898|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
309899|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309900|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
309901|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
309902|NCT00856908|B3|Baseline|Total|Total of all reporting groups
309903|NCT00856908|B2|Baseline|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309904|NCT00856908|B1|Baseline|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309905|NCT00856908|P2|Participant Flow|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309906|NCT00856908|P1|Participant Flow|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309907|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309908|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309909|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309910|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309911|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309912|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309913|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309914|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309915|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309916|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309917|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309918|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309919|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309920|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309921|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309922|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309923|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309924|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309925|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309926|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309927|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309928|NCT00856908|E2|Reported Event|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309929|NCT00856908|E1|Reported Event|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
309930|NCT00856843|B3|Baseline|Total|Total of all reporting groups
309931|NCT00856843|B2|Baseline|BLI800|Investigational prep - oral solution, 1 administration
309932|NCT00856843|B1|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309933|NCT00856843|P2|Participant Flow|BLI800|Investigational prep - oral solution, 1 administration
309934|NCT00856843|P1|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309935|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309936|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309937|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309938|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309939|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309940|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309941|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309942|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309943|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309944|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309945|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309946|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309947|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309948|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309949|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309950|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309951|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309952|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
316961|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
309953|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309954|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309955|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309956|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309957|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309958|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309959|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309960|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309961|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
309962|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309963|NCT00856843|E2|Reported Event|BLI800|Investigational prep - oral solution, 1 administration
309964|NCT00856843|E1|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
309965|NCT00856791|B1|Baseline|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
309966|NCT00856791|P1|Participant Flow|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
309967|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
309968|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
309969|NCT00856791|E1|Reported Event|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
309970|NCT00856778|B1|Baseline|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
309971|NCT00856778|P1|Participant Flow|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309972|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309973|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309974|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309975|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309976|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309977|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309978|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309979|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309980|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309981|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309982|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309983|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
310036|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310037|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310038|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
309984|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
309985|NCT00856778|E1|Reported Event|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
309986|NCT00856739|B4|Baseline|Total|Total of all reporting groups
309987|NCT00856739|B3|Baseline|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
309988|NCT00856739|B2|Baseline|Overweight|Body mass index between 25 and 30 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
309989|NCT00856739|B1|Baseline|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
309990|NCT00856739|P3|Participant Flow|Obese|Body mass index over 30 kg/m^2
309991|NCT00856739|P2|Participant Flow|Overweight|Body mass index between 25 and 30 kg/m^2
309992|NCT00856739|P1|Participant Flow|Normal Weight|Body mass index between 18 and 25 kg/m^2
309993|NCT00856739|O4|Outcome|Overweight and Obese Middle Age|Body mass index between 27 and 50 kg/m^2, age between 35 and 60
309994|NCT00856739|O3|Outcome|Normal Weight Middle Age|Body mass index between 18 and 25 kg/m^2, age between 35 and 60
309995|NCT00856739|O2|Outcome|Overweight and Obese Young|Body mass index between 27 and 50 kg/m^2, age between 20 and 35
309996|NCT00856739|O1|Outcome|Normal Weight Young|Body mass index between 18 and 25 kg/m^2, age between 20 and 35
309997|NCT00856739|O2|Outcome|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
309998|NCT00856739|O1|Outcome|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
309999|NCT00856739|E3|Reported Event|Obese|Body mass index between 30 and 50 kg/m^2
310000|NCT00856739|E2|Reported Event|Overweight|Body mass index between 25 and 30 kg/m^2
310001|NCT00856739|E1|Reported Event|Normal Weight|Body mass index between 18 and 25 kg/m^2
310002|NCT00856661|B3|Baseline|Total|Total of all reporting groups
310003|NCT00856661|B2|Baseline|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310004|NCT00856661|B1|Baseline|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310005|NCT00856661|P2|Participant Flow|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310006|NCT00856661|P1|Participant Flow|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310007|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310008|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310009|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310010|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310011|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310012|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310013|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310014|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310015|NCT00856661|E2|Reported Event|Desmoteplase|Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310016|NCT00856661|E1|Reported Event|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
310017|NCT00856635|B3|Baseline|Total|Total of all reporting groups
310018|NCT00856635|B2|Baseline|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
310019|NCT00856635|B1|Baseline|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
310020|NCT00856635|P2|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
310021|NCT00856635|P1|Participant Flow|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
310022|NCT00856635|O2|Outcome|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
310023|NCT00856635|O1|Outcome|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
310024|NCT00856635|E2|Reported Event|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
310025|NCT00856635|E1|Reported Event|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
310026|NCT00856583|B3|Baseline|Total|Total of all reporting groups
310027|NCT00856583|B2|Baseline|Risperidone|Normally in the range of 2 to 8 mg/day
310028|NCT00856583|B1|Baseline|Sertindole|Normally in the range of 4 to 20 mg/day
310029|NCT00856583|P2|Participant Flow|Risperidone|Normally in the range of 2 to 8 mg/day
310030|NCT00856583|P1|Participant Flow|Sertindole|Normally in the range of 4 to 20 mg/day
310031|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310032|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310033|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310034|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310035|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310039|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310040|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310041|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310042|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310043|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310044|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310045|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310046|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310047|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310048|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310049|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310050|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310051|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310052|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310053|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
310054|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
310055|NCT00856583|E2|Reported Event|Risperidone|Normally in the range of 2 to 8 mg/day
310056|NCT00856583|E1|Reported Event|Sertindole|Normally in the range of 4 to 20 mg/day
310057|NCT00856557|B3|Baseline|Total|Total of all reporting groups
310058|NCT00856557|B2|Baseline|No Intervention|No educational intervention
310059|NCT00856557|B1|Baseline|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310060|NCT00856557|P2|Participant Flow|No Intervention|No educational intervention
310061|NCT00856557|P1|Participant Flow|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310062|NCT00856557|O2|Outcome|No Intervention|No educational intervention
310063|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310064|NCT00856557|O2|Outcome|No Intervention|No educational intervention
310065|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310066|NCT00856557|O2|Outcome|No Intervention|No educational intervention
310067|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310068|NCT00856557|E2|Reported Event|No Intervention|No educational intervention
310069|NCT00856557|E1|Reported Event|Seminar and Practium|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
310070|NCT00856544|B5|Baseline|Total|Total of all reporting groups
310071|NCT00856544|B4|Baseline|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310072|NCT00856544|B3|Baseline|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310073|NCT00856544|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310074|NCT00856544|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310075|NCT00856544|P4|Participant Flow|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310103|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310133|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310189|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310076|NCT00856544|P3|Participant Flow|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310077|NCT00856544|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310078|NCT00856544|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310079|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310080|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310081|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310082|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310083|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310084|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310085|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310086|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310087|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310088|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310089|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310090|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310091|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310092|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310093|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310094|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310095|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310096|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310097|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310098|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310099|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310100|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310101|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310102|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310132|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310104|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310105|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310106|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310107|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310108|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310109|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310110|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310111|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310112|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310113|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310114|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310115|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310116|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310117|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310118|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310119|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310120|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310121|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310122|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310123|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310124|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310125|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310126|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310127|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310128|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310129|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310130|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310131|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310134|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310135|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310136|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310137|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310138|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310139|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310140|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310141|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310142|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310143|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310144|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310145|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310146|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310147|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310148|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310149|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310150|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310151|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310152|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310153|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310154|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310155|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310156|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310157|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310158|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310159|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310160|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310161|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310162|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310163|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310164|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310165|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310166|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310167|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310168|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310169|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310170|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310171|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310172|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310173|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310174|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310175|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310176|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310177|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310178|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310179|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310180|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310181|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310182|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310183|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310184|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310185|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310186|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310187|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310188|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310478|NCT00855816|E2|Reported Event|Treatment as Usual|No intervention: Treatment as usual
310190|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310191|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310192|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310193|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310194|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310195|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310196|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310197|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310198|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310199|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310200|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310201|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310202|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310203|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310204|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310205|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310206|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310207|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310208|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310209|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310210|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310211|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310212|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310213|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310214|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310215|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310246|NCT00856544|E8|Reported Event|Placebo, Then CP-690,550 10 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.
310216|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310217|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310218|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310219|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310220|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310221|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310222|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310223|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310224|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310225|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310226|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
310227|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
310228|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310229|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310230|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310231|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310232|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310233|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310234|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310235|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310236|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310237|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310238|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310239|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
310240|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
310241|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
310242|NCT00856544|E12|Reported Event|Placebo, Then CP-690,550 10 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
310243|NCT00856544|E11|Reported Event|Placebo, Then CP-690,550 5 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.
310244|NCT00856544|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
310245|NCT00856544|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
310247|NCT00856544|E7|Reported Event|Placebo, Then CP-690,550 5 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.
310248|NCT00856544|E6|Reported Event|Placebo (Month 3 to 6)|Matching placebo twice daily from Month 3 to 6.
310249|NCT00856544|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet twice daily from Month 3 to 6.
310250|NCT00856544|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg twice daily from Month 3 to 6.
310251|NCT00856544|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo Film-coated tablet orally twice daily up to Month 3.
310252|NCT00856544|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
310253|NCT00856544|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
310254|NCT00856518|B3|Baseline|Total|Total of all reporting groups
310255|NCT00856518|B2|Baseline|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
310256|NCT00856518|B1|Baseline|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
310257|NCT00856518|P2|Participant Flow|Arm 2: Sham Group|"sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
310258|NCT00856518|P1|Participant Flow|Arm 1: EMST|"Experimental Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
310259|NCT00856518|O2|Outcome|Arm 2: Sham Group|"The sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
310260|NCT00856518|O1|Outcome|Arm 1: EMST|"The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
310261|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
310262|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
310263|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
310264|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
310265|NCT00856518|E2|Reported Event|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
310266|NCT00856518|E1|Reported Event|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
310267|NCT00856414|B1|Baseline|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310268|NCT00856414|P1|Participant Flow|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310269|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310270|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310271|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310272|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310273|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310274|NCT00856414|E1|Reported Event|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
310275|NCT00856388|B1|Baseline|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310276|NCT00856388|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310277|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
310278|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310279|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310331|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310280|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310281|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310282|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310283|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310284|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
310285|NCT00856388|E1|Reported Event|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
310286|NCT00856349|B1|Baseline|Analysis Cohort|"Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.~Therapy Programming Report (TPR): Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study."
310287|NCT00856349|P1|Participant Flow|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
310288|NCT00856349|O1|Outcome|Subjects With Final Programming Data Available|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
310289|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
310290|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
310291|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
310292|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
310293|NCT00856349|O1|Outcome|Subjects With Paired Programming Data|Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
310294|NCT00856349|E1|Reported Event|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
310295|NCT00856323|B1|Baseline|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310296|NCT00856323|P1|Participant Flow|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310297|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310298|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310299|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310300|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310397|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310301|NCT00856323|E1|Reported Event|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
310302|NCT00856297|B6|Baseline|Total|Total of all reporting groups
310303|NCT00856297|B5|Baseline|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310304|NCT00856297|B4|Baseline|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
310305|NCT00856297|B3|Baseline|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310306|NCT00856297|B2|Baseline|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310307|NCT00856297|B1|Baseline|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310308|NCT00856297|P5|Participant Flow|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310309|NCT00856297|P4|Participant Flow|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310310|NCT00856297|P3|Participant Flow|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310311|NCT00856297|P2|Participant Flow|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310312|NCT00856297|P1|Participant Flow|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310313|NCT00856297|O3|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310314|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310315|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310316|NCT00856297|O4|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310317|NCT00856297|O3|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310318|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination..
310319|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310320|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310321|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310322|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310323|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310324|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310325|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310326|NCT00856297|O2|Outcome|Licensed Comparator/MenACWY-CRM|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study, and one booster dose of MenACWY- CRM conjugate vaccine in the present study at 3 years after primary vaccination.
310327|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310328|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310329|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310330|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
316962|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
310332|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310333|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310334|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310335|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310336|NCT00856297|E5|Reported Event|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
310337|NCT00856297|E4|Reported Event|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
310338|NCT00856297|E3|Reported Event|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
310339|NCT00856297|E2|Reported Event|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
310340|NCT00856297|E1|Reported Event|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
310341|NCT00856284|B4|Baseline|Total|Total of all reporting groups
310342|NCT00856284|B3|Baseline|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310343|NCT00856284|B2|Baseline|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310344|NCT00856284|B1|Baseline|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310345|NCT00856284|P3|Participant Flow|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310346|NCT00856284|P2|Participant Flow|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310347|NCT00856284|P1|Participant Flow|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310348|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310349|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310350|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310351|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310352|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310353|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310354|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310355|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310356|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310357|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310358|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310359|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310360|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310361|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310362|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310363|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310364|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310365|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310366|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310367|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310368|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310369|NCT00856284|E3|Reported Event|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
310370|NCT00856284|E2|Reported Event|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310371|NCT00856284|E1|Reported Event|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
310372|NCT00856232|B4|Baseline|Total|Total of all reporting groups
310373|NCT00856232|B3|Baseline|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
310374|NCT00856232|B2|Baseline|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
310375|NCT00856232|B1|Baseline|Standard Therapy|Standard emergency department evaluation and treatment for headache
310376|NCT00856232|P3|Participant Flow|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
310377|NCT00856232|P2|Participant Flow|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
310378|NCT00856232|P1|Participant Flow|Standard Therapy|Standard emergency department evaluation and treatment for headache
310379|NCT00856232|O3|Outcome|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
310380|NCT00856232|O2|Outcome|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
310381|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
310382|NCT00856232|O3|Outcome|Oxygen at 15 L / Min|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
310383|NCT00856232|O2|Outcome|Medical Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
310384|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
310385|NCT00856232|E3|Reported Event|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
310386|NCT00856232|E2|Reported Event|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
310387|NCT00856232|E1|Reported Event|Standard Therapy|Standard emergency department evaluation and treatment for headache
310388|NCT00856193|B1|Baseline|All Randomized Patients|NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
310389|NCT00856193|P2|Participant Flow|Placebo Then NVA237 50μg|Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
310390|NCT00856193|P1|Participant Flow|NVA237 50μg Then Placebo|NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
310391|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310392|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310393|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310394|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310395|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310396|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310398|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310399|NCT00856193|E2|Reported Event|NVA237 50 μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310400|NCT00856193|E1|Reported Event|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
310401|NCT00856180|B1|Baseline|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310402|NCT00856180|P1|Participant Flow|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310403|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310404|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310405|NCT00856180|O2|Outcome|Platinum Resistant|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a </=6 month interval since last receiving platinum therapy prior to disease recurrence.
310406|NCT00856180|O1|Outcome|Platinum Sensitive|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum sensitive is defined as having had a >6 month interval since last receiving platinum therapy prior to disease recurrence.
310407|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310408|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310409|NCT00856180|E1|Reported Event|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
310410|NCT00856050|B1|Baseline|Letrozole|letrozole 2.5mg by mouth per day
310411|NCT00856050|P1|Participant Flow|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
310412|NCT00856050|O1|Outcome|Letrozole|letrozole 2.5mg by mouth per day
310413|NCT00856050|E1|Reported Event|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
310414|NCT00856024|B1|Baseline|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310415|NCT00856024|P1|Participant Flow|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310416|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310417|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310440|NCT00855959|E1|Reported Event|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310441|NCT00855933|B3|Baseline|Total|Total of all reporting groups
310418|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310419|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310420|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310421|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310422|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310423|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310424|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310425|NCT00856024|E1|Reported Event|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
310426|NCT00855959|B1|Baseline|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310427|NCT00855959|P1|Participant Flow|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310428|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310429|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310430|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310431|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310432|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310433|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310434|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310435|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310436|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310437|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310438|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310439|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
310442|NCT00855933|B2|Baseline|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310443|NCT00855933|B1|Baseline|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310444|NCT00855933|P2|Participant Flow|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310445|NCT00855933|P1|Participant Flow|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310446|NCT00855933|O2|Outcome|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310447|NCT00855933|O1|Outcome|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310448|NCT00855933|E2|Reported Event|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310449|NCT00855933|E1|Reported Event|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
310450|NCT00855894|B1|Baseline|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310451|NCT00855894|P1|Participant Flow|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310452|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310453|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310454|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310455|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310456|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310457|NCT00855894|E1|Reported Event|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
310458|NCT00855868|B3|Baseline|Total|Total of all reporting groups
310459|NCT00855868|B2|Baseline|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
310460|NCT00855868|B1|Baseline|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
310461|NCT00855868|P2|Participant Flow|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
310462|NCT00855868|P1|Participant Flow|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
310463|NCT00855868|O2|Outcome|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
310464|NCT00855868|O1|Outcome|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
310465|NCT00855868|E2|Reported Event|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
310466|NCT00855868|E1|Reported Event|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
310467|NCT00855842|B1|Baseline|Osmotic Dilator|osmotic dilator
310468|NCT00855842|P1|Participant Flow|Osmotic Dilator|osmotic dilator
310469|NCT00855842|O1|Outcome|Osmotic Dilator|osmotic dilator
310470|NCT00855842|E1|Reported Event|Osmotic Dilator|osmotic dilator
310471|NCT00855816|B3|Baseline|Total|Total of all reporting groups
310472|NCT00855816|B2|Baseline|Treatment as Usual|No intervention: Treatment as usual
310473|NCT00855816|B1|Baseline|Breathing Training|relaxation training
310474|NCT00855816|P2|Participant Flow|Treatment as Usual|No intervention - treatment as usual
310475|NCT00855816|P1|Participant Flow|Breathing Training|relaxation training
310476|NCT00855816|O2|Outcome|Treatment as Usual|No intervention: treatment as usual
310477|NCT00855816|O1|Outcome|Breathing Training|relaxation training
310479|NCT00855816|E1|Reported Event|Breathing Training|relaxation training
310480|NCT00855738|B1|Baseline|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310481|NCT00855738|P1|Participant Flow|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310482|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310483|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310484|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310485|NCT00855738|O1|Outcome|All Antiepileptic Drugs|
310486|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310487|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310488|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310489|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310490|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310491|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310492|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310493|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310494|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310495|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310496|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310497|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310498|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310499|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310500|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310501|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310502|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310503|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
310504|NCT00855738|E2|Reported Event|Pregabalin (Pregabalin Only)|
310505|NCT00855738|E1|Reported Event|All Antiepileptic Drugs (Including Pregabalin)|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin
310506|NCT00855595|B3|Baseline|Total|Total of all reporting groups
310507|NCT00855595|B2|Baseline|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310508|NCT00855595|B1|Baseline|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310509|NCT00855595|P2|Participant Flow|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310510|NCT00855595|P1|Participant Flow|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310511|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310512|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310513|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310514|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310515|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310516|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310517|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310518|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310519|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310520|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310521|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310522|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310523|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310524|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310525|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310526|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310527|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310528|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310529|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310530|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310531|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310532|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310533|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310534|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310535|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310536|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310537|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310538|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310539|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310540|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310541|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
310542|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
310543|NCT00855595|E2|Reported Event|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
310544|NCT00855595|E1|Reported Event|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
310545|NCT00855582|B4|Baseline|Total|Total of all reporting groups
310546|NCT00855582|B3|Baseline|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310547|NCT00855582|B2|Baseline|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310548|NCT00855582|B1|Baseline|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310549|NCT00855582|P3|Participant Flow|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310550|NCT00855582|P2|Participant Flow|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310551|NCT00855582|P1|Participant Flow|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310552|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310553|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310554|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310555|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310556|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310557|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310558|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310559|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310560|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310561|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310562|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310563|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310564|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310565|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310566|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310567|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310568|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310569|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310570|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310571|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310572|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310573|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310574|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310575|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310576|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310577|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310578|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310579|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310580|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310581|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310582|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310583|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310584|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310585|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310586|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310587|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310588|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310589|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310590|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310591|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310592|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310593|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310594|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310595|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310596|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310597|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310598|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310599|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310600|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310601|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310602|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310603|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310604|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310605|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310606|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310607|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310608|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310609|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310610|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310611|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310612|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310613|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310614|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310615|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310616|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310617|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310618|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310619|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
310620|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310621|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
310622|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310623|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
310624|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310625|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
310626|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310627|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
310628|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310629|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
310630|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310631|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
310632|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310633|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
310634|NCT00855582|E3|Reported Event|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
310635|NCT00855582|E2|Reported Event|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
310636|NCT00855582|E1|Reported Event|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
310637|NCT00855465|B3|Baseline|Total|Total of all reporting groups
310638|NCT00855465|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310639|NCT00855465|B1|Baseline|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310640|NCT00855465|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310641|NCT00855465|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310642|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310643|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310644|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310645|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310646|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310647|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310648|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310649|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310650|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310651|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310652|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310653|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310654|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310655|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310656|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310657|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310658|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310659|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310660|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310661|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310662|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310663|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310664|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310665|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310666|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310667|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310668|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310669|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310670|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310671|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310672|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310673|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310674|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310675|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310676|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310677|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310678|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310679|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310680|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310681|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310682|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310683|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310684|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310685|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310686|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310687|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310688|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310689|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310690|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310691|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310692|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310693|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310694|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310695|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310696|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310697|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310698|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310699|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310700|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310701|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310702|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310703|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310704|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310705|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310706|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310707|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310708|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310709|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310710|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310711|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310712|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310713|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310714|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310715|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310716|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310717|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310718|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310719|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310720|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310721|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310722|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310723|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310724|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310725|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310726|NCT00855465|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
310727|NCT00855465|E1|Reported Event|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
310728|NCT00855439|B3|Baseline|Total|Total of all reporting groups
310867|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310729|NCT00855439|B2|Baseline|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310730|NCT00855439|B1|Baseline|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310731|NCT00855439|P2|Participant Flow|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310732|NCT00855439|P1|Participant Flow|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310733|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310734|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310735|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310736|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310737|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310738|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310739|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310740|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310741|NCT00855439|E2|Reported Event|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
310742|NCT00855439|E1|Reported Event|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
310743|NCT00855309|B3|Baseline|Total|Total of all reporting groups
310744|NCT00855309|B2|Baseline|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
310745|NCT00855309|B1|Baseline|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
310746|NCT00855309|P2|Participant Flow|Low-dose IV Acyclovir|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
310747|NCT00855309|P1|Participant Flow|Weight-based IV Acyclovir|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
310748|NCT00855309|O2|Outcome|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
310749|NCT00855309|O1|Outcome|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
310750|NCT00855309|E2|Reported Event|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
310751|NCT00855309|E1|Reported Event|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
310752|NCT00855218|B3|Baseline|Total|Total of all reporting groups
310753|NCT00855218|B2|Baseline|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310754|NCT00855218|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310819|NCT00854906|B1|Baseline|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.
310868|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310755|NCT00855218|P2|Participant Flow|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310756|NCT00855218|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310757|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310758|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310759|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310760|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310761|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310762|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310763|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310764|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310765|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310766|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310767|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
316963|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
310768|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310769|NCT00855218|E2|Reported Event|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310770|NCT00855218|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
310771|NCT00855166|B3|Baseline|Total|Total of all reporting groups
310772|NCT00855166|B2|Baseline|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310773|NCT00855166|B1|Baseline|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310774|NCT00855166|P2|Participant Flow|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310775|NCT00855166|P1|Participant Flow|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310776|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
310777|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
310778|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
310779|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
310780|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
310781|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
310782|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310783|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310784|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310785|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310786|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310787|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310788|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310789|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310790|NCT00855166|E2|Reported Event|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
310791|NCT00855166|E1|Reported Event|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
310792|NCT00855062|B3|Baseline|Total|Total of all reporting groups
310793|NCT00855062|B2|Baseline|Placebo|Placebo minocycline capsules every 12 hours
310794|NCT00855062|B1|Baseline|Minocycline|Minocycline 100 mg orally every 12 hours
310795|NCT00855062|P2|Participant Flow|Placebo|Placebo minocycline capsules every 12 hours
310796|NCT00855062|P1|Participant Flow|Minocycline|Minocycline 100 mg orally every 12 hours
310797|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310798|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310799|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310800|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310801|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310802|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310803|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310804|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310805|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310806|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310807|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310808|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310809|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310810|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310811|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310812|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310813|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310814|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310815|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
310816|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
310817|NCT00855062|E2|Reported Event|Placebo|Placebo minocycline capsules every 12 hours
310818|NCT00855062|E1|Reported Event|Minocycline|Minocycline 100 mg orally every 12 hours
310866|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310820|NCT00854906|P1|Participant Flow|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.
310821|NCT00854906|O1|Outcome|All Study Participants|
310822|NCT00854906|O2|Outcome|FTBUT|
310823|NCT00854906|O1|Outcome|KTBUT|
310824|NCT00854906|E2|Reported Event|FTBUT|
310825|NCT00854906|E1|Reported Event|KTBUT|
310826|NCT00854724|B3|Baseline|Total|Total of all reporting groups
310827|NCT00854724|B2|Baseline|Puerarin, Then Placebo|
310828|NCT00854724|B1|Baseline|Placebo, Then Puerarin|
310829|NCT00854724|P2|Participant Flow|Puerarin, Then Placebo|
310830|NCT00854724|P1|Participant Flow|Placebo, Then Puerarin|
310831|NCT00854724|O2|Outcome|Puerarin, Then Placebo|
310832|NCT00854724|O1|Outcome|Placebo, Then Puerarin|
310833|NCT00854724|E2|Reported Event|Puerarin, Then Placebo|
310834|NCT00854724|E1|Reported Event|Placebo, Then Puerarin|
310835|NCT00854620|B1|Baseline|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
310836|NCT00854620|P1|Participant Flow|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
310837|NCT00854620|O1|Outcome|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
310838|NCT00854620|E1|Reported Event|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
310839|NCT00854607|B1|Baseline|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
310840|NCT00854607|P1|Participant Flow|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
310841|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310842|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310843|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310844|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310845|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310846|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310847|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310848|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310849|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310850|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310851|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310852|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310853|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310854|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310855|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310856|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310857|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310858|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310859|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310860|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310861|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
310862|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
310863|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310864|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310865|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310869|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
310870|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
310871|NCT00854607|E1|Reported Event|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
310872|NCT00854594|B3|Baseline|Total|Total of all reporting groups
310873|NCT00854594|B2|Baseline|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310874|NCT00854594|B1|Baseline|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310875|NCT00854594|P2|Participant Flow|ReSPECT Intervention|"Providers within sites randomized to the intervention arm will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (CBOCs) by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310876|NCT00854594|P1|Participant Flow|Control|Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310877|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310878|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310879|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310880|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310881|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310882|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310883|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310884|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310916|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
316964|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
310885|NCT00854594|E2|Reported Event|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
310886|NCT00854594|E1|Reported Event|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
310887|NCT00854581|B1|Baseline|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
310888|NCT00854581|P1|Participant Flow|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
310889|NCT00854581|O1|Outcome|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
310890|NCT00854581|E2|Reported Event|Maintenance Therapy|"Zidovudine + Interferon alfa-2b + PEG Interferon alfa-2b~PEG-interferon alfa-2b: PEG-IFN-alfa2b 1.5 ug/kg SQ weekly.~Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.~Valproic Acid: Patients will be started on one capsule (250 mg) with water twice daily.~Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.~Molecular Evaluation/Analysis of Malignant Clones of ATLL: Blood Sample - Baseline/Pre-Treatment, months 3 and 6, End of Month 12, Disease Progession"
310891|NCT00854581|E1|Reported Event|Induction Therapy|"Zidovudine + Interferon alfa-2b~Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.~Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.~NF-kB Inhibition: Blood Sample - Baseline/Pre-Treatment, Induction,"
310892|NCT00854373|B3|Baseline|Total|Total of all reporting groups
310893|NCT00854373|B2|Baseline|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310894|NCT00854373|B1|Baseline|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310895|NCT00854373|P2|Participant Flow|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310896|NCT00854373|P1|Participant Flow|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310897|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310898|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310899|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310900|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310901|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310902|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310903|NCT00854373|E2|Reported Event|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
310904|NCT00854373|E1|Reported Event|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
310905|NCT00854360|B5|Baseline|Total|Total of all reporting groups
310906|NCT00854360|B4|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310907|NCT00854360|B3|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310908|NCT00854360|B2|Baseline|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310909|NCT00854360|B1|Baseline|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310910|NCT00854360|P4|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310911|NCT00854360|P3|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310912|NCT00854360|P2|Participant Flow|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310913|NCT00854360|P1|Participant Flow|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
310914|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310915|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310917|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310918|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310919|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310920|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310921|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310922|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310923|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310924|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310925|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310926|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310927|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310928|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310929|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310930|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310931|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310932|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310933|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310934|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310935|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310936|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310937|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310938|NCT00854360|E4|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
310939|NCT00854360|E3|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
310940|NCT00854360|E2|Reported Event|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
310941|NCT00854360|E1|Reported Event|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
310942|NCT00854308|B3|Baseline|Total|Total of all reporting groups
310943|NCT00854308|B2|Baseline|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310944|NCT00854308|B1|Baseline|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310945|NCT00854308|P2|Participant Flow|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310946|NCT00854308|P1|Participant Flow|MetMAb + Erlotinib|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310947|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310948|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310949|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310950|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310951|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310952|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310953|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310954|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310955|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310956|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310957|NCT00854308|E2|Reported Event|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
310958|NCT00854308|E1|Reported Event|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
310959|NCT00854113|B12|Baseline|Total|Total of all reporting groups
310960|NCT00854113|B11|Baseline|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
310961|NCT00854113|B10|Baseline|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
310962|NCT00854113|B9|Baseline|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
310963|NCT00854113|B8|Baseline|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
310964|NCT00854113|B7|Baseline|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
310965|NCT00854113|B6|Baseline|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
310966|NCT00854113|B5|Baseline|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
310967|NCT00854113|B4|Baseline|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
310968|NCT00854113|B3|Baseline|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
310969|NCT00854113|B2|Baseline|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
310970|NCT00854113|B1|Baseline|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
310971|NCT00854113|P11|Participant Flow|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
310972|NCT00854113|P10|Participant Flow|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
310973|NCT00854113|P9|Participant Flow|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
310974|NCT00854113|P8|Participant Flow|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
310975|NCT00854113|P7|Participant Flow|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
310976|NCT00854113|P6|Participant Flow|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
310977|NCT00854113|P5|Participant Flow|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
310978|NCT00854113|P4|Participant Flow|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
310979|NCT00854113|P3|Participant Flow|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
310980|NCT00854113|P2|Participant Flow|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
310981|NCT00854113|P1|Participant Flow|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
310982|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
310983|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
310984|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
310985|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
310986|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
310987|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
310988|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
310989|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
310990|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
310991|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
310992|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
310993|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
310994|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
310995|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
310996|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
310997|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
310998|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
310999|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311000|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311001|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311002|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311003|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311004|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311005|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311006|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311007|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311008|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311009|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311010|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311011|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311012|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311013|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311014|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311015|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311016|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311017|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311018|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311019|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311020|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311021|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311022|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311023|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311024|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311025|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311026|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311027|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311028|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311029|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311030|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311031|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311032|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311033|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311034|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311035|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311036|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311037|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311038|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311039|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311040|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311041|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311042|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311043|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311044|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311045|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311046|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311047|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311048|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311049|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311050|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311051|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311052|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
313038|NCT00849680|E2|Reported Event|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)|
311053|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311054|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311055|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311056|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311057|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311058|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311059|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311060|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311061|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311062|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311063|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311064|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311065|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311066|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311067|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311068|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311069|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311070|NCT00854113|E11|Reported Event|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
311071|NCT00854113|E10|Reported Event|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
311072|NCT00854113|E9|Reported Event|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
311073|NCT00854113|E8|Reported Event|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
311074|NCT00854113|E7|Reported Event|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
311075|NCT00854113|E6|Reported Event|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
311076|NCT00854113|E5|Reported Event|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
311077|NCT00854113|E4|Reported Event|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
311078|NCT00854113|E3|Reported Event|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
311079|NCT00854113|E2|Reported Event|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
311080|NCT00854113|E1|Reported Event|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
311081|NCT00854087|B3|Baseline|Total|Total of all reporting groups
311082|NCT00854087|B2|Baseline|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
311083|NCT00854087|B1|Baseline|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
311084|NCT00854087|P2|Participant Flow|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
311085|NCT00854087|P1|Participant Flow|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
311086|NCT00854087|O2|Outcome|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
311087|NCT00854087|O1|Outcome|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
311088|NCT00854087|E2|Reported Event|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
311089|NCT00854087|E1|Reported Event|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
311090|NCT00853970|B3|Baseline|Total|Total of all reporting groups
311091|NCT00853970|B2|Baseline|Placebo|one drop daily in study eye for 2 weeks
311092|NCT00853970|B1|Baseline|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
311093|NCT00853970|P2|Participant Flow|Placebo|dosed 1 drop daily into the study eye for 2 weeks
311094|NCT00853970|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.09%|dosed 1 drop daily into the study eye for 2 weeks
311095|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
311096|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
311097|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
311098|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
311099|NCT00853970|E2|Reported Event|Placebo|one drop daily in study eye for 2 weeks
311100|NCT00853970|E1|Reported Event|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
311101|NCT00853957|B3|Baseline|Total|Total of all reporting groups
311102|NCT00853957|B2|Baseline|Amlodipine|Amlodipine 5mg titrated to 10 mg
311103|NCT00853957|B1|Baseline|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311104|NCT00853957|P2|Participant Flow|Amlodipine|Amlodipine 5mg titrated to 10 mg
311105|NCT00853957|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311106|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311107|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311108|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311109|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311110|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311111|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311112|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311113|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311114|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311115|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311116|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
311117|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311118|NCT00853957|E2|Reported Event|Amlodipine|Amlodipine 5mg titrated to 10 mg
311119|NCT00853957|E1|Reported Event|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
311120|NCT00853905|B3|Baseline|Total|Total of all reporting groups
311121|NCT00853905|B2|Baseline|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
311122|NCT00853905|B1|Baseline|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
311123|NCT00853905|P2|Participant Flow|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
311124|NCT00853905|P1|Participant Flow|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
311125|NCT00853905|O2|Outcome|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
311126|NCT00853905|O1|Outcome|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
311127|NCT00853905|E2|Reported Event|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
311128|NCT00853905|E1|Reported Event|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
311129|NCT00853840|B1|Baseline|All Subjects|In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
311130|NCT00853840|P2|Participant Flow|Non-matching Placebo + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311131|NCT00853840|P1|Participant Flow|Vardenafil + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311132|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311133|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311134|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311135|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311136|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311242|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311137|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311138|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311139|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311140|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311141|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311142|NCT00853840|E3|Reported Event|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
311143|NCT00853840|E2|Reported Event|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
311144|NCT00853840|E1|Reported Event|Maraviroc Run-In|All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
311145|NCT00853827|B3|Baseline|Total|Total of all reporting groups
311146|NCT00853827|B2|Baseline|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311147|NCT00853827|B1|Baseline|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311148|NCT00853827|P2|Participant Flow|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311149|NCT00853827|P1|Participant Flow|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311150|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311151|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311152|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311153|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311154|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311155|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311156|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311271|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311157|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311158|NCT00853827|E2|Reported Event|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
311159|NCT00853827|E1|Reported Event|Aliskiren 300 mg|Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
311160|NCT00853762|B5|Baseline|Total|Total of all reporting groups
311161|NCT00853762|B4|Baseline|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311162|NCT00853762|B3|Baseline|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311163|NCT00853762|B2|Baseline|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311164|NCT00853762|B1|Baseline|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311165|NCT00853762|P4|Participant Flow|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311166|NCT00853762|P3|Participant Flow|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311167|NCT00853762|P2|Participant Flow|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311168|NCT00853762|P1|Participant Flow|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311169|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311170|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311171|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311172|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311173|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311174|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311175|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311176|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311177|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311270|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311178|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311179|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311180|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311181|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311182|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311183|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311184|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311185|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311186|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311187|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311188|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311189|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311190|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311191|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311192|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311193|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311194|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311195|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311196|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311197|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311198|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311353|NCT00853567|B4|Baseline|Total|Total of all reporting groups
311199|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311200|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311201|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311202|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311203|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311204|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311205|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311206|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311207|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311208|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311209|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311210|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311211|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311212|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311213|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311214|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311215|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311216|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311217|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311218|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311219|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311354|NCT00853567|B3|Baseline|Placebo|Placebo treatment
311220|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311221|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311222|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311223|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311224|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311225|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311226|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311227|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311228|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311229|NCT00853762|E4|Reported Event|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC as loading dose twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311230|NCT00853762|E3|Reported Event|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311231|NCT00853762|E2|Reported Event|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311232|NCT00853762|E1|Reported Event|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
311233|NCT00853749|B3|Baseline|Total|Total of all reporting groups
311234|NCT00853749|B2|Baseline|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311235|NCT00853749|B1|Baseline|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311236|NCT00853749|P2|Participant Flow|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311237|NCT00853749|P1|Participant Flow|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311238|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311239|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311240|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311241|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311243|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311244|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311245|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311246|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311247|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311248|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311249|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311250|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
311251|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
311252|NCT00853749|E2|Reported Event|PCV/PCV/13vPnC|"For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5."
311253|NCT00853749|E1|Reported Event|PCV/23vPS/13vPnC|"For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9."
311254|NCT00853723|B4|Baseline|Total|Total of all reporting groups
311255|NCT00853723|B3|Baseline|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311256|NCT00853723|B2|Baseline|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311257|NCT00853723|B1|Baseline|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311258|NCT00853723|P3|Participant Flow|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311259|NCT00853723|P2|Participant Flow|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311260|NCT00853723|P1|Participant Flow|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311261|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311262|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311263|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311264|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311265|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311266|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311267|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311268|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311269|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311587|NCT00853333|B3|Baseline|Propofol|
311272|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311273|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311274|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311275|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311276|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311277|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311278|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311279|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311280|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311281|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311282|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311283|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311284|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311285|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311286|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311287|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311288|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311289|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311290|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311291|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311292|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311293|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311294|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311295|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311296|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311297|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
311298|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
311299|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
311300|NCT00853723|E3|Reported Event|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
311301|NCT00853723|E2|Reported Event|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
311302|NCT00853723|E1|Reported Event|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
311303|NCT00853658|B4|Baseline|Total|Total of all reporting groups
311304|NCT00853658|B3|Baseline|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311305|NCT00853658|B2|Baseline|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311306|NCT00853658|B1|Baseline|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
311307|NCT00853658|P3|Participant Flow|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311588|NCT00853333|B2|Baseline|Midazolam|
311308|NCT00853658|P2|Participant Flow|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311309|NCT00853658|P1|Participant Flow|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
311310|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311311|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311312|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
311313|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311314|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311315|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
311316|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311317|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311318|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
311319|NCT00853658|E3|Reported Event|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
311320|NCT00853658|E2|Reported Event|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
311321|NCT00853658|E1|Reported Event|Combination of Aliskiren and Enalapril|Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
311322|NCT00853606|B1|Baseline|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311323|NCT00853606|P1|Participant Flow|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311324|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311325|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311326|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311327|NCT00853606|E1|Reported Event|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
311328|NCT00853593|B1|Baseline|Model 4396 LV Lead|Subjects underwent Model 4396 left ventricular lead implant attempt
311329|NCT00853593|P1|Participant Flow|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311330|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration R-wave amplitude at 6 month.
311331|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration pacing impedance at 6 month.
311332|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
311333|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at implant.
311334|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode pacing impedance at 6 month.
311335|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
311336|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at 6 month.
311337|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode pacing impedance at 6 month.
311338|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode threshold captured at 0.5ms at 6 month.
311339|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
311340|NCT00853593|O1|Outcome|Model 4396 LV Lead|Model 4396 lead implant attempts.
311341|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311342|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311343|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311344|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311345|NCT00853593|O1|Outcome|Any Medtronic LV Lead (Attain Family Lead)|Subjects who underwent an implant attempt.
311346|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt.
311347|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt with successful CS cannulation.
311348|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311349|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month.
311350|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode capture at 0.5ms at 1-month.
311351|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects who underwent a Model 4396 left ventricular lead implant attempt
311352|NCT00853593|E1|Reported Event|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
311355|NCT00853567|B2|Baseline|50 mg Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
311356|NCT00853567|B1|Baseline|25 g Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
311357|NCT00853567|P1|Participant Flow|All Arms|Proellex: 25 mg or 50 mg or placebo oral daily dose
311358|NCT00853567|O3|Outcome|Placebo|"Placebo treatment~placebo: Placebo"
311359|NCT00853567|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
311360|NCT00853567|O1|Outcome|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
311361|NCT00853567|E3|Reported Event|Placebo|"Placebo treatment~placebo: Placebo"
311362|NCT00853567|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
311363|NCT00853567|E1|Reported Event|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
311364|NCT00853385|B6|Baseline|Total|Total of all reporting groups
311365|NCT00853385|B5|Baseline|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311366|NCT00853385|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311367|NCT00853385|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311368|NCT00853385|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311369|NCT00853385|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311370|NCT00853385|P5|Participant Flow|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311371|NCT00853385|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311372|NCT00853385|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311373|NCT00853385|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311374|NCT00853385|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311375|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311376|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311377|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311589|NCT00853333|B1|Baseline|Dexmedetomidine|
313039|NCT00849680|E1|Reported Event|Placebo|
311378|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311379|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311380|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311381|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311382|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311383|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311384|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311385|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311386|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311387|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311388|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311389|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311390|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311391|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311392|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311393|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311394|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311395|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311396|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311397|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311398|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311399|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311400|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311401|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311402|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311403|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311404|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311405|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311406|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311407|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311408|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311409|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311410|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311411|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311412|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311413|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311414|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311415|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311416|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311590|NCT00853333|P3|Participant Flow|Propofol|Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
311591|NCT00853333|P2|Participant Flow|Midazolam|Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
311592|NCT00853333|P1|Participant Flow|Dexmedetomidine|Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
311593|NCT00853333|O3|Outcome|Propofol|
311594|NCT00853333|O2|Outcome|Midazolam|
311595|NCT00853333|O1|Outcome|Dexmedetomidine|
311417|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311418|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311419|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311420|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311421|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311422|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311423|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311424|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311425|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311426|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311427|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311428|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311429|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311430|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311431|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311432|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311433|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311434|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311596|NCT00853333|E3|Reported Event|Propofol|
311597|NCT00853333|E2|Reported Event|Midazolam|
311598|NCT00853333|E1|Reported Event|Dexmedetomidine|
311599|NCT00853242|B8|Baseline|Total|Total of all reporting groups
311600|NCT00853242|B7|Baseline|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311601|NCT00853242|B6|Baseline|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311435|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311436|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311437|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311438|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311439|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311440|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311441|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311442|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311443|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311444|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311445|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311446|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311447|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311448|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311449|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311450|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311451|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311452|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311602|NCT00853242|B5|Baseline|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311603|NCT00853242|B4|Baseline|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311604|NCT00853242|B3|Baseline|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311605|NCT00853242|B2|Baseline|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311453|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311454|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311455|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311456|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311457|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311458|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311459|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311460|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311461|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311462|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311463|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311464|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311465|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311466|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311467|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311468|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311469|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311470|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311606|NCT00853242|B1|Baseline|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311607|NCT00853242|P7|Participant Flow|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311608|NCT00853242|P6|Participant Flow|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311609|NCT00853242|P5|Participant Flow|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311471|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311472|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311473|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311474|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311475|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311476|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311477|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311478|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311479|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311480|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311481|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311482|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311483|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311484|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311485|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311486|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311487|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311488|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311610|NCT00853242|P4|Participant Flow|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311611|NCT00853242|P3|Participant Flow|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311612|NCT00853242|P2|Participant Flow|Genz-644470 2.4 Grams Per Day (g/Day)|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311613|NCT00853242|P1|Participant Flow|Placebo|Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
311489|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311490|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311491|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311492|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311493|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311494|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311495|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311496|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311497|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311498|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311499|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311500|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311501|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311502|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311503|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311504|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311505|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311506|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311614|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311615|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311616|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311617|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311507|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311508|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311509|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311510|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311511|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311512|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311513|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311514|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311515|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311516|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311517|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311518|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311519|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311520|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311521|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311522|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311523|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311524|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311525|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311526|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311527|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311528|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311529|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311530|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311531|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311532|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311533|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311534|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311535|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311536|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311537|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311538|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311539|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311540|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311541|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311542|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311543|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311544|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311545|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311618|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311619|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311620|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311621|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311546|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311547|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311548|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311549|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311550|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311551|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311552|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311553|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311554|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311555|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311556|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311557|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311558|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311559|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311560|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311561|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311562|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311563|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311622|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311623|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311624|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311625|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311564|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311565|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311566|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311567|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311568|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311569|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311570|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311571|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
311572|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311573|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311574|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311575|NCT00853385|E11|Reported Event|Adalimumab (Post Month 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
311576|NCT00853385|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
311577|NCT00853385|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
311578|NCT00853385|E8|Reported Event|Adalimumab (Month 3 to 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
311579|NCT00853385|E7|Reported Event|Placebo (Month 3 to 6)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311580|NCT00853385|E6|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
311581|NCT00853385|E5|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
311582|NCT00853385|E4|Reported Event|Adalimumab (Up To Month 3)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
311583|NCT00853385|E3|Reported Event|Placebo (Up To Month 3)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
311584|NCT00853385|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
311585|NCT00853385|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
311586|NCT00853333|B4|Baseline|Total|Total of all reporting groups
311626|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311627|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311628|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311629|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311630|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311631|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311632|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311633|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311634|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311635|NCT00853242|O6|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311636|NCT00853242|O5|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311637|NCT00853242|O4|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311638|NCT00853242|O3|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311639|NCT00853242|O2|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311640|NCT00853242|O1|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311641|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311642|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311643|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311644|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311645|NCT00853242|E7|Reported Event|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311646|NCT00853242|E6|Reported Event|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311647|NCT00853242|E5|Reported Event|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311648|NCT00853242|E4|Reported Event|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
311649|NCT00853242|E3|Reported Event|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
311650|NCT00853242|E2|Reported Event|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
311651|NCT00853242|E1|Reported Event|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
311652|NCT00853151|B5|Baseline|Total|Total of all reporting groups
311653|NCT00853151|B4|Baseline|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311654|NCT00853151|B3|Baseline|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311655|NCT00853151|B2|Baseline|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311656|NCT00853151|B1|Baseline|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311657|NCT00853151|P4|Participant Flow|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311658|NCT00853151|P3|Participant Flow|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311659|NCT00853151|P2|Participant Flow|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311660|NCT00853151|P1|Participant Flow|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311661|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311662|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311663|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311664|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311665|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311666|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311667|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311668|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311669|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311670|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311671|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
312635|NCT00850603|P4|Participant Flow|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
311672|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311673|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311674|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311675|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311676|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311677|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311678|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311679|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311680|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311681|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311682|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311683|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311684|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311685|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311686|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311687|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311688|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311689|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311690|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311691|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311692|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311693|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311694|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311695|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311696|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311697|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311698|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311699|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311700|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311701|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311702|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311703|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311704|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311705|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311706|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311707|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311708|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311709|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311710|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311711|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311712|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311713|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311714|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311715|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
311716|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311717|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311718|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311719|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311720|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311721|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311722|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311723|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311724|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311725|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311726|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311727|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
311728|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311729|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311730|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311731|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311732|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311733|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311734|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311735|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311736|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311737|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311738|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311739|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311740|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311741|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311742|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311743|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311744|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311745|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311746|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311747|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311748|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311749|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311750|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311751|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311752|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311753|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311754|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311755|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311756|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311757|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311758|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311759|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311760|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311761|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311762|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311763|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311764|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311765|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311766|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311767|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311768|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311769|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311770|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311771|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311772|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311773|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311774|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311775|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311776|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311777|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311778|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311779|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311780|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311781|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311782|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311783|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311784|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311785|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311786|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311787|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311788|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311789|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311790|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311791|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311792|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311793|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311794|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311795|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311796|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311797|NCT00853151|E4|Reported Event|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311798|NCT00853151|E3|Reported Event|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
311799|NCT00853151|E2|Reported Event|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
311800|NCT00853151|E1|Reported Event|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
311801|NCT00853099|B4|Baseline|Total|Total of all reporting groups
311802|NCT00853099|B3|Baseline|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311803|NCT00853099|B2|Baseline|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311804|NCT00853099|B1|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311805|NCT00853099|P4|Participant Flow|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
311806|NCT00853099|P3|Participant Flow|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
311807|NCT00853099|P2|Participant Flow|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
311808|NCT00853099|P1|Participant Flow|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
311809|NCT00853099|O1|Outcome|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
311810|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311811|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311812|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311813|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311814|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
312636|NCT00850603|P3|Participant Flow|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
311815|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311816|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311817|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311818|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311819|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311820|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311821|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311822|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311823|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311824|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311825|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311826|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311827|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311828|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311867|NCT00852995|B2|Baseline|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311829|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311830|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311831|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311832|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311833|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311834|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311835|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311836|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311837|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311838|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311839|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311840|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311841|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311842|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
311843|NCT00853099|E4|Reported Event|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
311844|NCT00853099|E3|Reported Event|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
311845|NCT00853099|E2|Reported Event|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
311846|NCT00853099|E1|Reported Event|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
311847|NCT00853073|B3|Baseline|Total|Total of all reporting groups
311848|NCT00853073|B2|Baseline|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
311849|NCT00853073|B1|Baseline|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
311850|NCT00853073|P2|Participant Flow|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
311851|NCT00853073|P1|Participant Flow|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
311852|NCT00853073|O2|Outcome|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
311853|NCT00853073|O1|Outcome|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
311854|NCT00853073|E2|Reported Event|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
311855|NCT00853073|E1|Reported Event|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
311856|NCT00853021|B1|Baseline|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311857|NCT00853021|P1|Participant Flow|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311858|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311859|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311860|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311861|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311862|NCT00853021|E1|Reported Event|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
311863|NCT00852995|B6|Baseline|Total|Total of all reporting groups
311864|NCT00852995|B5|Baseline|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311865|NCT00852995|B4|Baseline|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311866|NCT00852995|B3|Baseline|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
312637|NCT00850603|P2|Participant Flow|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
311868|NCT00852995|B1|Baseline|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311869|NCT00852995|P5|Participant Flow|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311870|NCT00852995|P4|Participant Flow|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311871|NCT00852995|P3|Participant Flow|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311872|NCT00852995|P2|Participant Flow|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311873|NCT00852995|P1|Participant Flow|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311874|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311875|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311876|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311877|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311878|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311879|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311880|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311881|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311882|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311883|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311884|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311885|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311886|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311887|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311888|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311889|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311890|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311891|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311892|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
312638|NCT00850603|P1|Participant Flow|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
311893|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311894|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311895|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311896|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311897|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311898|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311899|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311900|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311901|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311902|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311903|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311904|NCT00852995|O5|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311905|NCT00852995|O4|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311906|NCT00852995|O3|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311907|NCT00852995|O2|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311908|NCT00852995|O1|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311909|NCT00852995|E5|Reported Event|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311910|NCT00852995|E4|Reported Event|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311911|NCT00852995|E3|Reported Event|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311912|NCT00852995|E2|Reported Event|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
311913|NCT00852995|E1|Reported Event|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
311914|NCT00852969|B3|Baseline|Total|Total of all reporting groups
311915|NCT00852969|B2|Baseline|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
311916|NCT00852969|B1|Baseline|Niacin|Niacin : 1000 mg tablets once per day
311917|NCT00852969|P2|Participant Flow|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
311918|NCT00852969|P1|Participant Flow|Niacin|Niacin : 1000 mg tablets once per day
311919|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
311920|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
311921|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
311922|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
311923|NCT00852969|E2|Reported Event|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
311924|NCT00852969|E1|Reported Event|Niacin|Niacin : 1000 mg tablets once per day
311925|NCT00852930|B4|Baseline|Total|Total of all reporting groups
311926|NCT00852930|B3|Baseline|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311927|NCT00852930|B2|Baseline|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
311928|NCT00852930|B1|Baseline|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311929|NCT00852930|P3|Participant Flow|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311930|NCT00852930|P2|Participant Flow|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
311931|NCT00852930|P1|Participant Flow|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311932|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311933|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage (mld)~manual lymphatic drainage: therapist administered massage therapy"
311934|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311935|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311936|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
311937|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311938|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311939|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
311940|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311941|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
311942|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
311943|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
311944|NCT00852930|E3|Reported Event|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment~No adverse events during the study."
311945|NCT00852930|E2|Reported Event|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy~No adverse events during the study."
311946|NCT00852930|E1|Reported Event|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser~No adverse events during the study."
311947|NCT00852917|B5|Baseline|Total|Total of all reporting groups
311948|NCT00852917|B4|Baseline|4: Placebo|
311949|NCT00852917|B3|Baseline|3: Tramadol Once A Day 300mg|
311950|NCT00852917|B2|Baseline|2: Tramadol Once A Day 200mg|
311951|NCT00852917|B1|Baseline|1: Tramadol Once A Day 100mg|
311952|NCT00852917|P4|Participant Flow|4: Placebo|
311953|NCT00852917|P3|Participant Flow|3: Tramadol Once A Day 300mg|
311954|NCT00852917|P2|Participant Flow|2: Tramadol Once A Day 200mg|
311955|NCT00852917|P1|Participant Flow|1: Tramadol Once A Day 100mg|
311956|NCT00852917|O4|Outcome|4: Placebo|
311957|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311958|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311959|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311960|NCT00852917|O4|Outcome|4: Placebo|
311961|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311962|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311963|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311964|NCT00852917|O4|Outcome|4: Placebo|
311965|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311966|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311967|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311968|NCT00852917|O4|Outcome|4: Placebo|
311969|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311970|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311971|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311972|NCT00852917|O4|Outcome|4: Placebo|
311973|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311974|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311975|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311976|NCT00852917|O4|Outcome|4: Placebo|
311977|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311978|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311979|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311980|NCT00852917|O4|Outcome|4: Placebo|
311981|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311982|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311983|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311984|NCT00852917|O4|Outcome|4: Placebo|
311985|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
311986|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
311987|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
311988|NCT00852917|E4|Reported Event|4: Placebo|
311989|NCT00852917|E3|Reported Event|3: Tramadol Once A Day 300mg|
311990|NCT00852917|E2|Reported Event|2: Tramadol Once A Day 200mg|
311991|NCT00852917|E1|Reported Event|1: Tramadol Once A Day 100mg|
311992|NCT00852761|B3|Baseline|Total|Total of all reporting groups
311993|NCT00852761|B2|Baseline|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
311994|NCT00852761|B1|Baseline|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
311995|NCT00852761|P2|Participant Flow|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
311996|NCT00852761|P1|Participant Flow|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
311997|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
311998|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
311999|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312000|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312001|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312002|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312003|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312004|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312005|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312006|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312007|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312008|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312009|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312010|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312011|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312012|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312013|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312014|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312015|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312016|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312017|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312018|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312019|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312020|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312021|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312022|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312023|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312024|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312025|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312026|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312027|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312028|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312029|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312030|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312031|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312032|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312033|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312034|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312035|NCT00852761|E2|Reported Event|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
312036|NCT00852761|E1|Reported Event|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
312037|NCT00851786|B3|Baseline|Total|Total of all reporting groups
312038|NCT00851786|B2|Baseline|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
312039|NCT00851786|B1|Baseline|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
312040|NCT00851786|P2|Participant Flow|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
312041|NCT00851786|P1|Participant Flow|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
312042|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
312043|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
312044|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
312045|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
312046|NCT00851786|E2|Reported Event|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
312047|NCT00851786|E1|Reported Event|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
312048|NCT00851721|B3|Baseline|Total|Total of all reporting groups
312049|NCT00851721|B2|Baseline|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312050|NCT00851721|B1|Baseline|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
312051|NCT00851721|P2|Participant Flow|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312052|NCT00851721|P1|Participant Flow|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
312053|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312054|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312055|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312056|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312057|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312058|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312059|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312060|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312061|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312062|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312063|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312064|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312065|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312066|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312067|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312068|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312069|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312070|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312071|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312072|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312073|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312074|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312075|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
314476|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
312076|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312077|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312078|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312079|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312080|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312081|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312082|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312083|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312084|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312085|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312086|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312087|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312088|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312089|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312090|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312091|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312092|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312093|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312094|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312095|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312096|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312097|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312098|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312099|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312100|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312101|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312102|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312103|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312104|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312105|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312106|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312107|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312108|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312109|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312110|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312111|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312112|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312113|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312114|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312115|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312116|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312117|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312118|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312119|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312120|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312121|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312122|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312123|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312124|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312125|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312126|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312127|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312128|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
312129|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
312130|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312131|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312132|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
312133|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312134|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312135|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
312136|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
312137|NCT00851721|E2|Reported Event|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month ± 14 days prophylactic period
312138|NCT00851721|E1|Reported Event|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
312139|NCT00851682|B3|Baseline|Total|Total of all reporting groups
312140|NCT00851682|B2|Baseline|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312141|NCT00851682|B1|Baseline|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312142|NCT00851682|P2|Participant Flow|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312143|NCT00851682|P1|Participant Flow|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312144|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312145|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312146|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312147|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312148|NCT00851682|E2|Reported Event|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312149|NCT00851682|E1|Reported Event|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
312150|NCT00851643|B7|Baseline|Total|Total of all reporting groups
312151|NCT00851643|B6|Baseline|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312152|NCT00851643|B5|Baseline|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312153|NCT00851643|B4|Baseline|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312154|NCT00851643|B3|Baseline|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312155|NCT00851643|B2|Baseline|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312156|NCT00851643|B1|Baseline|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312157|NCT00851643|P6|Participant Flow|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312158|NCT00851643|P5|Participant Flow|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312159|NCT00851643|P4|Participant Flow|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312160|NCT00851643|P3|Participant Flow|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312191|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312161|NCT00851643|P2|Participant Flow|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312162|NCT00851643|P1|Participant Flow|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
312163|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
312164|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
312165|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
312166|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
312167|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
312168|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
312169|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
312170|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
312171|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
312172|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
312173|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
312174|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
312175|NCT00851643|E5|Reported Event|Octavalent With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
312176|NCT00851643|E4|Reported Event|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
312177|NCT00851643|E3|Reported Event|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
312178|NCT00851643|E2|Reported Event|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
312179|NCT00851643|E1|Reported Event|qHPV (GARDASIL™) - Phase A and Phase B Controls|Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
312180|NCT00851630|B3|Baseline|Total|Total of all reporting groups
312181|NCT00851630|B2|Baseline|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312182|NCT00851630|B1|Baseline|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312183|NCT00851630|P2|Participant Flow|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312184|NCT00851630|P1|Participant Flow|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312185|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312186|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312187|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312188|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312189|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312190|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
314477|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
312192|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312193|NCT00851630|E2|Reported Event|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
312194|NCT00851630|E1|Reported Event|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
312195|NCT00852631|B1|Baseline|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312196|NCT00852631|P1|Participant Flow|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312197|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312198|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312199|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312200|NCT00852631|E1|Reported Event|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
312201|NCT00852592|B3|Baseline|Total|Total of all reporting groups
312202|NCT00852592|B2|Baseline|Inactive Comparator|"inactive light unit~Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily"
312203|NCT00852592|B1|Baseline|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
312204|NCT00852592|P2|Participant Flow|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
312205|NCT00852592|P1|Participant Flow|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
312206|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
312207|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
312208|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
312209|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
312210|NCT00852592|E2|Reported Event|Inactive Comparator|inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
312211|NCT00852592|E1|Reported Event|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
312212|NCT00852540|B3|Baseline|Total|Total of all reporting groups
312213|NCT00852540|B2|Baseline|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312214|NCT00852540|B1|Baseline|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312215|NCT00852540|P2|Participant Flow|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312216|NCT00852540|P1|Participant Flow|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312217|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312218|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
316965|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312219|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312220|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312221|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312222|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312223|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312224|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312225|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312226|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312227|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312228|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312229|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
316966|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
312230|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312231|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312232|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312233|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312234|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312235|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312236|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312237|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312238|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312239|NCT00852540|E2|Reported Event|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
312275|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312276|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312277|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312240|NCT00852540|E1|Reported Event|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
312241|NCT00852527|B1|Baseline|OEF/OIF Veterans|Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
312242|NCT00852527|P2|Participant Flow|Negative Mild TBI|Participants who screened negative on the TBI Clinical Reminder Screen
312243|NCT00852527|P1|Participant Flow|Positive Mild TBI|Participants who screened positive on the TBI Clinical Reminder Screen
312244|NCT00852527|O2|Outcome|Veterans Assessed With the Structured TBI Diagnostic Interview|
312245|NCT00852527|O1|Outcome|Veterans Assessed With the Comprehensive TBI Evaluation|
312246|NCT00852527|E1|Reported Event|OEF/OIF Veterans|No adverse events.
312247|NCT00852475|B3|Baseline|Total|Total of all reporting groups
312248|NCT00852475|B2|Baseline|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
312249|NCT00852475|B1|Baseline|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
312250|NCT00852475|P2|Participant Flow|PUFA|"Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
312251|NCT00852475|P1|Participant Flow|MUFA|"Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program"
312252|NCT00852475|O2|Outcome|PUFA Arm|Assessment of FMD after 6 months of PUFA enrichment
312253|NCT00852475|O1|Outcome|MUFA Arm|Assessment of FMD after six months of MUFA enrichment
312254|NCT00852475|O2|Outcome|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
312255|NCT00852475|O1|Outcome|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
312256|NCT00852475|E2|Reported Event|PUFA|subjects received a diet enriched in PUFA
312257|NCT00852475|E1|Reported Event|MUFA|subjects received a diet enriched in MUFA
312258|NCT00852397|B4|Baseline|Total|Total of all reporting groups
312259|NCT00852397|B3|Baseline|Apixaban 5.0 mg BID|"Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
312260|NCT00852397|B2|Baseline|Apixaban 2.5 mg BID|"2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
312261|NCT00852397|B1|Baseline|Placebo|"Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
312262|NCT00852397|P3|Participant Flow|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312263|NCT00852397|P2|Participant Flow|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312264|NCT00852397|P1|Participant Flow|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312265|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312266|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312267|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312268|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312269|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312270|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312271|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312272|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312273|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312274|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312639|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312278|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312279|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312280|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312281|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312282|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312283|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312284|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312285|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312286|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312287|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312288|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312289|NCT00852397|E3|Reported Event|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312290|NCT00852397|E2|Reported Event|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312291|NCT00852397|E1|Reported Event|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
312292|NCT00852137|B3|Baseline|Total|Total of all reporting groups
312293|NCT00852137|B2|Baseline|Vehicle|Vehicle gel once daily for 2 consecutive days
312294|NCT00852137|B1|Baseline|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312295|NCT00852137|P2|Participant Flow|Vehicle|Vehicle gel once daily for 2 consecutive days
312296|NCT00852137|P1|Participant Flow|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312297|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312298|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312299|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312300|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312301|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312302|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312303|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312304|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312305|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312306|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312307|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312308|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312309|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312310|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312311|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
312312|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312313|NCT00852137|E2|Reported Event|Vehicle|Vehicle gel once daily for 2 consecutive days
312314|NCT00852137|E1|Reported Event|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
312315|NCT00852124|B3|Baseline|Total|Total of all reporting groups
312316|NCT00852124|B2|Baseline|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
312317|NCT00852124|B1|Baseline|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
312318|NCT00852124|P2|Participant Flow|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
312319|NCT00852124|P1|Participant Flow|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
312320|NCT00852124|O1|Outcome|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
312321|NCT00852124|E2|Reported Event|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
312322|NCT00852124|E1|Reported Event|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
312334|NCT00851890|B4|Baseline|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312323|NCT00851903|B1|Baseline|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312324|NCT00851903|P1|Participant Flow|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312325|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312326|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312327|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312328|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312329|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312330|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312331|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312332|NCT00851903|E1|Reported Event|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
312333|NCT00851890|B5|Baseline|Total|Total of all reporting groups
312498|NCT00851552|P1|Participant Flow|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
316967|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312335|NCT00851890|B3|Baseline|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312336|NCT00851890|B2|Baseline|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312337|NCT00851890|B1|Baseline|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312338|NCT00851890|P4|Participant Flow|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312339|NCT00851890|P3|Participant Flow|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312340|NCT00851890|P2|Participant Flow|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312341|NCT00851890|P1|Participant Flow|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312342|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312343|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312344|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312345|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312346|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312347|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312348|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312349|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312350|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312351|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312352|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
316968|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
312353|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312354|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312355|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312356|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312357|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312358|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312359|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312360|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312361|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312362|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312363|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312364|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312365|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312366|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312367|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312368|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312369|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312370|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
314478|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
312371|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312372|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312373|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312374|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312375|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312376|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312377|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312378|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312379|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312380|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312381|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312382|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312383|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312384|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312385|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312386|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312387|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312388|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
314479|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
312389|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312390|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312391|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312392|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
312393|NCT00851890|E4|Reported Event|Placebo + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
312394|NCT00851890|E3|Reported Event|ABT-333 (1200 mg) Once Daily (QD) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
312395|NCT00851890|E2|Reported Event|ABT-333 (600 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
312396|NCT00851890|E1|Reported Event|ABT-333 (300 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
312397|NCT00851799|B4|Baseline|Total|Total of all reporting groups
312398|NCT00851799|B3|Baseline|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312399|NCT00851799|B2|Baseline|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312400|NCT00851799|B1|Baseline|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312401|NCT00851799|P3|Participant Flow|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312402|NCT00851799|P2|Participant Flow|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312403|NCT00851799|P1|Participant Flow|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312404|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312405|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312406|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312407|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312408|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312499|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
312409|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312410|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312411|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312412|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312413|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312414|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312415|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312416|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312417|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312418|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312419|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312420|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312421|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312422|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312423|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312424|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312425|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312426|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312427|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312428|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312429|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312632|NCT00850603|B2|Baseline|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
316969|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312430|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312431|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312432|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312433|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312434|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312435|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312436|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312437|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312438|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312439|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312440|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312441|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312442|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312443|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312444|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312445|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312446|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312447|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312448|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312449|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312450|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312633|NCT00850603|B1|Baseline|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
316970|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
312451|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312452|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312453|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312454|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312455|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312456|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312457|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312458|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312459|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312460|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312461|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312462|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312463|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312464|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312465|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312466|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312467|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312468|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312469|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312470|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312471|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312634|NCT00850603|P5|Participant Flow|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312472|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312473|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312474|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312475|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312476|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312477|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312478|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312479|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312480|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312481|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312482|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312483|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312484|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312485|NCT00851799|E3|Reported Event|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
312486|NCT00851799|E2|Reported Event|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
312487|NCT00851799|E1|Reported Event|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
312488|NCT00851591|B3|Baseline|Total|Total of all reporting groups
312489|NCT00851591|B2|Baseline|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
312490|NCT00851591|B1|Baseline|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
312491|NCT00851591|P2|Participant Flow|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
312492|NCT00851591|P1|Participant Flow|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
312493|NCT00851591|O2|Outcome|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
312494|NCT00851591|O1|Outcome|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
312495|NCT00851591|E2|Reported Event|2 Group Scheduled to Receive Placebo|Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
312496|NCT00851591|E1|Reported Event|1 Group Scheduled to Receive Fenugreek|Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days.
312497|NCT00851552|B1|Baseline|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
312500|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
312501|NCT00851552|E1|Reported Event|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
312502|NCT00851409|B1|Baseline|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
312503|NCT00851409|P1|Participant Flow|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
312504|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
312505|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
312506|NCT00851409|E1|Reported Event|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
312507|NCT00851318|B5|Baseline|Total|Total of all reporting groups
312508|NCT00851318|B4|Baseline|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312509|NCT00851318|B3|Baseline|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312510|NCT00851318|B2|Baseline|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312511|NCT00851318|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312512|NCT00851318|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312513|NCT00851318|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312514|NCT00851318|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312515|NCT00851318|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312516|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312517|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312518|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312519|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312520|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312521|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312522|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312523|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312524|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312525|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312526|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312527|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312528|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312529|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312530|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312531|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312532|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312533|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312534|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312535|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312536|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312537|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312538|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312539|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312540|NCT00851318|E4|Reported Event|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312541|NCT00851318|E3|Reported Event|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312542|NCT00851318|E2|Reported Event|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312543|NCT00851318|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312544|NCT00851279|B1|Baseline|Magnetic Irrigated Ablation Catheter|Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
312545|NCT00851279|P1|Participant Flow|Magnetic Irrigated Ablation Catheter|Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
312546|NCT00851279|O1|Outcome|Magnetic Irrigated Ablation Catheter|Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
312547|NCT00851279|E1|Reported Event|Magnetic Irrigated Ablation Catheter|"Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system~There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window"
312548|NCT00851084|B3|Baseline|Total|Total of all reporting groups
312549|NCT00851084|B2|Baseline|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312550|NCT00851084|B1|Baseline|mFOLFOX6 Only|modified FOLFOX6
312551|NCT00851084|P2|Participant Flow|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312552|NCT00851084|P1|Participant Flow|mFOLFOX6 Only|modified FOLFOX6
312553|NCT00851084|O2|Outcome|Positive|Positive antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
312554|NCT00851084|O1|Outcome|Negative or Missing|Negative or missing antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
312555|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312556|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
312557|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312558|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
312559|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312560|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
312561|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312562|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
312563|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312564|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
312565|NCT00851084|E2|Reported Event|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
312566|NCT00851084|E1|Reported Event|mFOLFOX6 Only|modified FOLFOX6
312567|NCT00851006|B1|Baseline|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13–18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
312568|NCT00851006|P2|Participant Flow|Healthy Control Group|Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
312569|NCT00851006|P1|Participant Flow|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.
312570|NCT00851006|O2|Outcome|Healthy Control Group|6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
312571|NCT00851006|O1|Outcome|Open Label Creatine Treatment|"MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.~Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks."
312572|NCT00851006|O1|Outcome|Open Label Creatine Treatment|The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
312573|NCT00851006|E2|Reported Event|Healthy Control Group|Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
312574|NCT00851006|E1|Reported Event|Open Label Creatine Treatment|There were no serious adverse events were experienced in this study.
312575|NCT00850993|B5|Baseline|Total|Total of all reporting groups
312576|NCT00850993|B4|Baseline|Stanate® 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312577|NCT00850993|B3|Baseline|Stanate® 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312578|NCT00850993|B2|Baseline|Stanate® 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312579|NCT00850993|B1|Baseline|Placebo|Saline : Normal saline (0.9%) solution
312580|NCT00850993|P4|Participant Flow|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312581|NCT00850993|P3|Participant Flow|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312582|NCT00850993|P2|Participant Flow|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312583|NCT00850993|P1|Participant Flow|Placebo|Saline : Normal saline (0.9%) solution
312584|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
316971|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312585|NCT00850993|O3|Outcome|Stannsoporfin3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312586|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312587|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
312588|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312589|NCT00850993|O3|Outcome|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312590|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312591|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
312592|NCT00850993|E4|Reported Event|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312593|NCT00850993|E3|Reported Event|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312594|NCT00850993|E2|Reported Event|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
312595|NCT00850993|E1|Reported Event|Placebo|Saline : Normal saline (0.9%) solution
312596|NCT00850889|B1|Baseline|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
312597|NCT00850889|P1|Participant Flow|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
312598|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
312599|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
312600|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
312601|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
312602|NCT00850889|O1|Outcome|Total Study Participants|
312603|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
312604|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
312605|NCT00850889|E2|Reported Event|Restylane|
312606|NCT00850889|E1|Reported Event|Juvederm Ultra Injectable Gel With Lidocaine|
312607|NCT00850759|B5|Baseline|Total|Total of all reporting groups
312608|NCT00850759|B4|Baseline|No-contact Control|no-contact control group.
312609|NCT00850759|B3|Baseline|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
312610|NCT00850759|B2|Baseline|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
312611|NCT00850759|B1|Baseline|Virtual Reality|street-crossing training in a virtual pedestrian environment
312612|NCT00850759|P4|Participant Flow|No-contact Control|no-contact control group.
312613|NCT00850759|P3|Participant Flow|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
312614|NCT00850759|P2|Participant Flow|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
312615|NCT00850759|P1|Participant Flow|Virtual Reality|street-crossing training in a virtual pedestrian environment
312616|NCT00850759|O4|Outcome|No-contact Control|no-contact control group.
312617|NCT00850759|O3|Outcome|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
312618|NCT00850759|O2|Outcome|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
312619|NCT00850759|O1|Outcome|Virtual Reality|street-crossing training in a virtual pedestrian environment
312620|NCT00850759|E4|Reported Event|No-contact Control|no-contact control group.
312621|NCT00850759|E3|Reported Event|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
312622|NCT00850759|E2|Reported Event|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
312623|NCT00850759|E1|Reported Event|Virtual Reality|street-crossing training in a virtual pedestrian environment
312624|NCT00850720|B1|Baseline|Cardiac Surgery|Infants with congenital defects.
312625|NCT00850720|P1|Participant Flow|Cardiac Surgery|Infants with congenital defects.
312626|NCT00850720|O1|Outcome|Cardiac Surgery|Infants with congenital defects.
312627|NCT00850720|E1|Reported Event|Cardiac Surgery|Infants with congenital defects.
312628|NCT00850603|B6|Baseline|Total|Total of all reporting groups
312629|NCT00850603|B5|Baseline|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312630|NCT00850603|B4|Baseline|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
312631|NCT00850603|B3|Baseline|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
316972|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
312640|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
312641|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
312642|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
312643|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
312644|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312645|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
312646|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
312647|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
312648|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
312649|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312650|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
312651|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
312652|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
312653|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
312654|NCT00850603|E5|Reported Event|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
312655|NCT00850603|E4|Reported Event|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
312656|NCT00850603|E3|Reported Event|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
312657|NCT00850603|E2|Reported Event|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
312658|NCT00850603|E1|Reported Event|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
312659|NCT00850564|B1|Baseline|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
312660|NCT00850564|P1|Participant Flow|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
312661|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
312662|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
312663|NCT00850564|E1|Reported Event|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
312664|NCT00850538|B1|Baseline|Enrolled|"Subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
312665|NCT00850538|P1|Participant Flow|Enrolled|"Inclusion Criteria:~- subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
312666|NCT00850538|O1|Outcome|Specimens|Viable specimens for genetic analysis
312667|NCT00850538|E1|Reported Event|Enrolled|subjects having primary knee replacement surgery
312668|NCT00850499|B3|Baseline|Total|Total of all reporting groups
312669|NCT00850499|B2|Baseline|Rituximab + Fludarabine|
312670|NCT00850499|B1|Baseline|Velcade + Fludarabine|
312671|NCT00850499|P2|Participant Flow|Rituximab + Fludarabine|
312672|NCT00850499|P1|Participant Flow|Velcade + Fludarabine|
312673|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
312674|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
312675|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
312676|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
312677|NCT00850499|E2|Reported Event|Rituximab + Fludarabine|
312678|NCT00850499|E1|Reported Event|Velcade + Fludarabine|
312679|NCT00850460|B3|Baseline|Total|Total of all reporting groups
312680|NCT00850460|B2|Baseline|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
312681|NCT00850460|B1|Baseline|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
312682|NCT00850460|P2|Participant Flow|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
312683|NCT00850460|P1|Participant Flow|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
312684|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
312685|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
312686|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
316973|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312687|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
312688|NCT00850460|E2|Reported Event|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
312689|NCT00850460|E1|Reported Event|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
312690|NCT00849524|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312691|NCT00849524|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312692|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312693|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312694|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312695|NCT00849524|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
312696|NCT00849485|B3|Baseline|Total|Total of all reporting groups
312697|NCT00849485|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
312698|NCT00849485|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
312699|NCT00849485|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
312700|NCT00849485|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
312701|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312702|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312703|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312704|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312705|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312706|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312707|NCT00850421|B1|Baseline|Botulinum Toxin Type A|
312708|NCT00850421|P1|Participant Flow|Botulinum Toxin Type A|
312709|NCT00850421|O1|Outcome|Botulinum Toxin Type A|
312710|NCT00850421|E1|Reported Event|Botulinum Toxin Type A|
312711|NCT00850395|B1|Baseline|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312712|NCT00850395|P1|Participant Flow|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312713|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312714|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312715|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312716|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312717|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312718|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312719|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
314480|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
312720|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312721|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312722|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312723|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312724|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312725|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312726|NCT00850395|E1|Reported Event|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
312727|NCT00850343|B5|Baseline|Total|Total of all reporting groups
312728|NCT00850343|B4|Baseline|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312729|NCT00850343|B3|Baseline|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312730|NCT00850343|B2|Baseline|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312731|NCT00850343|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312732|NCT00850343|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312733|NCT00850343|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312734|NCT00850343|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312735|NCT00850343|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312736|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312737|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312738|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312739|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312740|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312741|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312742|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312743|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312744|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
314481|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
312745|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312746|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312747|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312748|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312749|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312750|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312751|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312752|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312753|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312754|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312755|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312756|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312757|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312758|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312759|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312760|NCT00850343|E4|Reported Event|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312761|NCT00850343|E3|Reported Event|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312762|NCT00850343|E2|Reported Event|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312763|NCT00850343|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
312764|NCT00850200|B1|Baseline|Proton Therapy Plan Compared to IMRT and Conventional RT|Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
312765|NCT00850200|P1|Participant Flow|Optimal Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
312766|NCT00850200|O3|Outcome|Intensity Modulated Radiation Plan|Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
312767|NCT00850200|O2|Outcome|Conventional Photon Radiation Plan|Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
312768|NCT00850200|O1|Outcome|Proton Radiation Plan|Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
312769|NCT00850200|E1|Reported Event|Superior Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
312770|NCT00850174|B3|Baseline|Total|Total of all reporting groups
312771|NCT00850174|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
312772|NCT00850174|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
312773|NCT00850174|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
312774|NCT00850174|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
312775|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312776|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312777|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312778|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312779|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312780|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312781|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312782|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312783|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312784|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312785|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312786|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312787|NCT00850135|B1|Baseline|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
312788|NCT00850135|P1|Participant Flow|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
312789|NCT00850135|O2|Outcome|Participants With AUC 130 >22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
312790|NCT00850135|O1|Outcome|Participants With AUC 130 <= 22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
312791|NCT00850135|O1|Outcome|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
312792|NCT00850135|E1|Reported Event|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
312793|NCT00850096|B3|Baseline|Total|Total of all reporting groups
312794|NCT00850096|B2|Baseline|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
312795|NCT00850096|B1|Baseline|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
312796|NCT00850096|P2|Participant Flow|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
312797|NCT00850096|P1|Participant Flow|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
312841|NCT00849901|P2|Participant Flow|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312798|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
312799|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
312800|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
312801|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
312802|NCT00850096|E2|Reported Event|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
312803|NCT00850096|E1|Reported Event|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
312804|NCT00850070|B3|Baseline|Total|Total of all reporting groups
312805|NCT00850070|B2|Baseline|Placebo|sugar pill
312806|NCT00850070|B1|Baseline|Sapropterin|tetrahydrobiopterin (BH4)
312807|NCT00850070|P2|Participant Flow|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
312808|NCT00850070|P1|Participant Flow|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
312809|NCT00850070|O2|Outcome|Placebo|sugar pill
312810|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
312811|NCT00850070|O2|Outcome|Placebo|sugar pill
312812|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
312813|NCT00850070|O2|Outcome|Placebo|sugar pill
312814|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
312815|NCT00850070|O2|Outcome|Placebo|sugar pill
312816|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
312817|NCT00850070|O2|Outcome|Placebo|sugar pill
312818|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
312819|NCT00850070|O2|Outcome|Placebo|sugar pill
312820|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
312821|NCT00850070|E2|Reported Event|Placebo|sugar pill
312822|NCT00850070|E1|Reported Event|Sapropterin|sapropterin 20 mg/kg/day
312823|NCT00850031|B1|Baseline|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision"
312824|NCT00850031|P1|Participant Flow|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
312825|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
312826|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
312827|NCT00850031|E1|Reported Event|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
312828|NCT00849940|B1|Baseline|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312829|NCT00849940|P1|Participant Flow|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312830|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312831|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312832|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312833|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312834|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312835|NCT00849940|E1|Reported Event|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
312836|NCT00849901|B4|Baseline|Total|Total of all reporting groups
312837|NCT00849901|B3|Baseline|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312838|NCT00849901|B2|Baseline|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312839|NCT00849901|B1|Baseline|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312840|NCT00849901|P3|Participant Flow|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312842|NCT00849901|P1|Participant Flow|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312843|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312844|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312845|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312846|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312847|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312848|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312849|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312850|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312851|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312852|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312853|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312854|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312855|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312856|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312857|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312858|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312859|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312860|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312861|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312862|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312863|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312864|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312865|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312866|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312867|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312868|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312869|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312870|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312871|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312872|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312873|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312874|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
312875|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
312876|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
312877|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312878|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312879|NCT00849901|E6|Reported Event|Placebo/Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312880|NCT00849901|E5|Reported Event|Fluoxetine - Extension|Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).
312881|NCT00849901|E4|Reported Event|Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
312882|NCT00849901|E3|Reported Event|Placebo - Acute|Received placebo PO, QD during acute treatment phase
312883|NCT00849901|E2|Reported Event|Fluoxetine - Acute|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
312884|NCT00849901|E1|Reported Event|Duloxetine - Acute|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
312885|NCT00849862|B3|Baseline|Total|Total of all reporting groups
312886|NCT00849862|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
316974|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
312887|NCT00849862|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
312888|NCT00849862|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
312889|NCT00849862|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
312890|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312891|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312892|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312893|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312894|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
312895|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
312896|NCT00849810|B1|Baseline|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
312897|NCT00849810|P1|Participant Flow|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
312898|NCT00849810|O1|Outcome|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
312899|NCT00849810|E1|Reported Event|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
312900|NCT00849797|B3|Baseline|Total|Total of all reporting groups
312901|NCT00849797|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
312902|NCT00849797|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
312903|NCT00849797|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
312904|NCT00849797|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
312905|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312906|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312907|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312908|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312909|NCT00849797|O2|Outcome|Trileptal|Trileptal® 600 mg Tablet (reference) dosed in either period
312910|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312911|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312912|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312913|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312914|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312915|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
312916|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
312917|NCT00849693|B5|Baseline|Total|Total of all reporting groups
312918|NCT00849693|B4|Baseline|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312919|NCT00849693|B3|Baseline|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312920|NCT00849693|B2|Baseline|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312921|NCT00849693|B1|Baseline|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312922|NCT00849693|P4|Participant Flow|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312923|NCT00849693|P3|Participant Flow|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
313035|NCT00849680|E5|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)|
312924|NCT00849693|P2|Participant Flow|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312925|NCT00849693|P1|Participant Flow|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312926|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312927|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312928|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312929|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312930|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312931|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312932|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312933|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312934|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312935|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312936|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312937|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312938|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312939|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312940|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312941|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312942|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312943|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312944|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312945|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312946|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312947|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312948|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312949|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312950|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312951|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312952|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312953|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312954|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312955|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312956|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312957|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312958|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312959|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
313036|NCT00849680|E4|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)|
316975|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
312960|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312961|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312962|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312963|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312964|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312965|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312966|NCT00849693|O3|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312967|NCT00849693|O2|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
312968|NCT00849693|O1|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
312969|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312970|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
312971|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312972|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
312973|NCT00849693|O2|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
312974|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
312975|NCT00849693|E8|Reported Event|Placebo/Duloxetine - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
312976|NCT00849693|E7|Reported Event|Fluoxetine 20 mg - Extension|Fluoxetine 20-40 mg, orally, once daily for 6 months
312977|NCT00849693|E6|Reported Event|Duloxetine 30 mg - Extension|"Duloxetine 60-120 mg , orally, once daily for 6 months~One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section])."
312978|NCT00849693|E5|Reported Event|Duloxetine 60 mg - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
312979|NCT00849693|E4|Reported Event|Placebo - Acute|Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
312980|NCT00849693|E3|Reported Event|Fluoxetine 20 mg - Acute|Fluoxetine 20 mg, orally, once daily for 10 weeks
312981|NCT00849693|E2|Reported Event|Duloxetine 30 mg - Acute|Duloxetine 30 mg, orally, once daily for 10 weeks
312982|NCT00849693|E1|Reported Event|Duloxetine 60 mg - Acute|Duloxetine 60 mg, orally, once daily for 10 weeks
312983|NCT00849680|B9|Baseline|Total|Total of all reporting groups
312984|NCT00849680|B8|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
312985|NCT00849680|B7|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
312986|NCT00849680|B6|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
312987|NCT00849680|B5|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
312988|NCT00849680|B4|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
312989|NCT00849680|B3|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
312990|NCT00849680|B2|Baseline|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
312991|NCT00849680|B1|Baseline|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
312992|NCT00849680|P8|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
312993|NCT00849680|P7|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
312994|NCT00849680|P6|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
312995|NCT00849680|P5|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
312996|NCT00849680|P4|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
312997|NCT00849680|P3|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
313037|NCT00849680|E3|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)|
312998|NCT00849680|P2|Participant Flow|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
312999|NCT00849680|P1|Participant Flow|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
313000|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
313001|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
313002|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
313003|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
313004|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
313005|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
313006|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
313007|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
313008|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
313009|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
313010|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
313011|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
313012|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
313013|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
313014|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
313015|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
313016|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
313017|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
313018|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
313019|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
313020|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
313021|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
313022|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
313023|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
313024|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
313025|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
313026|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
313027|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
313028|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
313029|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
313030|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
313031|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
313032|NCT00849680|E8|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)|
313033|NCT00849680|E7|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)|
313034|NCT00849680|E6|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)|
313040|NCT00849472|B1|Baseline|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313041|NCT00849472|P1|Participant Flow|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313042|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313043|NCT00849472|O1|Outcome|Overall Study Arm|
313044|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313045|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313046|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313047|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313048|NCT00849472|O1|Outcome|Overall Study Arm|
313049|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313050|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313051|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313052|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313081|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
316976|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313053|NCT00849472|E1|Reported Event|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
313054|NCT00849381|B1|Baseline|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313055|NCT00849381|P1|Participant Flow|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313056|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313057|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313058|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313059|NCT00849381|E1|Reported Event|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
313060|NCT00849290|B1|Baseline|APC8015F|
313061|NCT00849290|P1|Participant Flow|APC8015F|APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
313062|NCT00849290|O1|Outcome|APC8015F|
313063|NCT00849290|E1|Reported Event|APC8015F|
313064|NCT00849212|B1|Baseline|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
313065|NCT00849212|P1|Participant Flow|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
313066|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
313067|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
313068|NCT00849212|E1|Reported Event|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
313069|NCT00849186|B1|Baseline|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313070|NCT00849186|P1|Participant Flow|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313071|NCT00849186|O1|Outcome|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313072|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313073|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313074|NCT00849186|E1|Reported Event|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
313075|NCT00849147|B1|Baseline|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313076|NCT00849147|P1|Participant Flow|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313077|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313078|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313079|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313080|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313082|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313083|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313084|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313085|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313086|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313087|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313088|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313089|NCT00849147|E1|Reported Event|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
313090|NCT00849121|B3|Baseline|Total|Total of all reporting groups
313091|NCT00849121|B2|Baseline|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313092|NCT00849121|B1|Baseline|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313093|NCT00849121|P2|Participant Flow|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313094|NCT00849121|P1|Participant Flow|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression"
313095|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313096|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313097|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313098|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313099|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313100|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313101|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313590|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
313102|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313103|NCT00849121|E2|Reported Event|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
313104|NCT00849121|E1|Reported Event|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
313105|NCT00849108|B4|Baseline|Total|Total of all reporting groups
313106|NCT00849108|B3|Baseline|Cohort 2: Efficacy Exercise Stress|"Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period.~For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose."
313107|NCT00849108|B2|Baseline|Cohort 2: Pharm Stress|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose.
313108|NCT00849108|B1|Baseline|Cohort 1 Dose Ranging and Dose Interval|Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
313109|NCT00849108|P2|Participant Flow|Cohort 2 Preliminary Efficacy Pharmacologic Stress|Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period.
313110|NCT00849108|P1|Participant Flow|Cohort 1 Dose Ranging and Dose Interval|Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
313111|NCT00849108|O1|Outcome|Cohort 2: Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
313112|NCT00849108|O1|Outcome|Cohort 1 Dose Ranging and Dose Interval|Subjects received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
313113|NCT00849108|O1|Outcome|Cohort 2 Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
313114|NCT00849108|O1|Outcome|Cohort 1: Dose Acquistion Time Product|Subjects received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
313115|NCT00849108|E2|Reported Event|Cohort 2: Efficacy in Pharm Stress|"Patients receive 2 IV injections of BMS747158:at rest and stress~For the Pharmacologic (Adenosine) Stress:~Doses range at rest between 2.9 and 3.4 mCi.~Dose range at stress between 5.8 and 8.2 mCi (factor of 2.0 to 2.4 greater than the rest dose).~For the Exercise Stress:~Doses at rest were to range between 1.7 and 2.0 mCi.~Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
313116|NCT00849108|E1|Reported Event|Cohort 1: Dose Range and Dose Interval|"Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.~BMS747158: dosages at rest and at stress were not to exceed a total of 14 mCi.~Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period."
313117|NCT00849056|B3|Baseline|Total|Total of all reporting groups
313118|NCT00849056|B2|Baseline|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313119|NCT00849056|B1|Baseline|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313120|NCT00849056|P2|Participant Flow|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313121|NCT00849056|P1|Participant Flow|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313218|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313122|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313123|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313124|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313125|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313126|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313127|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313128|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313129|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313130|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313131|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313132|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313133|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313134|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313135|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313136|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313591|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
313137|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313138|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313139|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313140|NCT00849056|E2|Reported Event|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313141|NCT00849056|E1|Reported Event|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
313142|NCT00849017|B4|Baseline|Total|Total of all reporting groups
313143|NCT00849017|B3|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313144|NCT00849017|B2|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313145|NCT00849017|B1|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313146|NCT00849017|P3|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313147|NCT00849017|P2|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313148|NCT00849017|P1|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313149|NCT00849017|O2|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313150|NCT00849017|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313151|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313152|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313153|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313154|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313155|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313156|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313157|NCT00849017|O3|Outcome|Albiglutide 50 mg Weekly|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313158|NCT00849017|O2|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313159|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313160|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313161|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313162|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313163|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313164|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313165|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313166|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313167|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313168|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313169|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313170|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313171|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313172|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313173|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313174|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313175|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313176|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313177|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313178|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313179|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313180|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313181|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313182|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313183|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313184|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313185|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313186|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313187|NCT00849017|E3|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313188|NCT00849017|E2|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313189|NCT00849017|E1|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
313190|NCT00848965|B1|Baseline|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
313191|NCT00848965|P1|Participant Flow|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
313192|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313193|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313194|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313195|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313196|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313197|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313198|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313199|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313200|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313201|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313202|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313203|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313204|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313205|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313206|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313207|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313208|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313209|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313210|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313211|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313212|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313213|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313214|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313215|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313216|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313217|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313219|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313220|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313221|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313222|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313223|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313224|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313225|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313226|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313227|NCT00848965|E5|Reported Event|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313228|NCT00848965|E4|Reported Event|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313229|NCT00848965|E3|Reported Event|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313230|NCT00848965|E2|Reported Event|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
313231|NCT00848965|E1|Reported Event|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
313232|NCT00848926|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313233|NCT00848926|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
313234|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313235|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313236|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313237|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313238|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313239|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313240|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313241|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313242|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313243|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313244|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313245|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313246|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313247|NCT00848926|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
313248|NCT00848783|B4|Baseline|Total|Total of all reporting groups
313249|NCT00848783|B3|Baseline|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
313250|NCT00848783|B2|Baseline|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
313251|NCT00848783|B1|Baseline|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
313252|NCT00848783|P3|Participant Flow|Induction Treartment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
313253|NCT00848783|P2|Participant Flow|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
313254|NCT00848783|P1|Participant Flow|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
313255|NCT00848783|O2|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
313256|NCT00848783|O1|Outcome|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
313257|NCT00848783|E2|Reported Event|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
314482|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
313258|NCT00848783|E1|Reported Event|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
313259|NCT00848744|B1|Baseline|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
313260|NCT00848744|P1|Participant Flow|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
313261|NCT00848744|O2|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
313262|NCT00848744|O1|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
313263|NCT00848744|E1|Reported Event|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
313264|NCT00848549|B3|Baseline|Total|Total of all reporting groups
313265|NCT00848549|B2|Baseline|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313266|NCT00848549|B1|Baseline|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313267|NCT00848549|P2|Participant Flow|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313268|NCT00848549|P1|Participant Flow|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313269|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313270|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313271|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313272|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313273|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313274|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313275|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313276|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313277|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313278|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313279|NCT00848549|E4|Reported Event|Carbamazepine (Base Study 310, NCT00477295)|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
313305|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313280|NCT00848549|E3|Reported Event|Zonisamide (Base Study 310, NCT00477295)|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
313281|NCT00848549|E2|Reported Event|Carbamazepine (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313282|NCT00848549|E1|Reported Event|Zonisamide (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
313283|NCT00848536|B3|Baseline|Total|Total of all reporting groups
313284|NCT00848536|B2|Baseline|TRAVATAN|One drop once daily in the evening for 3 months
313285|NCT00848536|B1|Baseline|TRAVATAN APS|One drop once daily in the evening for 3 months
313286|NCT00848536|P2|Participant Flow|TRAVATAN|One drop once daily in the evening for 3 months
313287|NCT00848536|P1|Participant Flow|TRAVATAN APS|One drop once daily in the evening for 3 months
313288|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
313289|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
313290|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
313291|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
313292|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
313293|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
313294|NCT00848536|E2|Reported Event|TRAVATAN|One drop once daily in the evening for 3 months
313295|NCT00848536|E1|Reported Event|TRAVATAN APS|One drop once daily in the evening for 3 months
313296|NCT00848510|B5|Baseline|Total|Total of all reporting groups
313297|NCT00848510|B4|Baseline|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313298|NCT00848510|B3|Baseline|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313299|NCT00848510|B2|Baseline|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313300|NCT00848510|B1|Baseline|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313301|NCT00848510|P4|Participant Flow|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313302|NCT00848510|P3|Participant Flow|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313303|NCT00848510|P2|Participant Flow|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313304|NCT00848510|P1|Participant Flow|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313374|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313592|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
313306|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313307|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313308|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313309|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313310|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313311|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313312|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313313|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313314|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313315|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313316|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313317|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313318|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313319|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313375|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313593|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
313320|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313321|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313322|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313323|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313324|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313325|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313326|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313327|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313328|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313329|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313330|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313331|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313332|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313333|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313376|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313594|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
313334|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313335|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313336|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313337|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313338|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313339|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313340|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313341|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313342|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313343|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313344|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313345|NCT00848510|E4|Reported Event|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313346|NCT00848510|E3|Reported Event|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313347|NCT00848510|E2|Reported Event|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313377|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
314187|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313348|NCT00848510|E1|Reported Event|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
313349|NCT00848497|B3|Baseline|Total|Total of all reporting groups
313350|NCT00848497|B2|Baseline|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313351|NCT00848497|B1|Baseline|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313352|NCT00848497|P2|Participant Flow|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313353|NCT00848497|P1|Participant Flow|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313354|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313355|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313356|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313357|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313358|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313359|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313360|NCT00848497|O2|Outcome|Placebo Testim + Viagra|"Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = 0 SHIM at 5 months = 0"
313361|NCT00848497|O1|Outcome|Testim + Viagra|"Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = N/A SHIM at 5 months = N/A"
313362|NCT00848497|E2|Reported Event|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
313363|NCT00848497|E1|Reported Event|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
313364|NCT00848484|B3|Baseline|Total|Total of all reporting groups
313365|NCT00848484|B2|Baseline|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
313366|NCT00848484|B1|Baseline|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
313367|NCT00848484|P2|Participant Flow|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
313368|NCT00848484|P1|Participant Flow|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
313369|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313370|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313371|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313372|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313373|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313378|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313379|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313380|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313381|NCT00848484|E2|Reported Event|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313382|NCT00848484|E1|Reported Event|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
313383|NCT00848367|B3|Baseline|Total|Total of all reporting groups
313384|NCT00848367|B2|Baseline|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
313385|NCT00848367|B1|Baseline|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
313386|NCT00848367|P2|Participant Flow|High Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
313387|NCT00848367|P1|Participant Flow|Low Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
313388|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
313389|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
313390|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
313391|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
313392|NCT00848367|E2|Reported Event|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
313393|NCT00848367|E1|Reported Event|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
313394|NCT00848354|B3|Baseline|Total|Total of all reporting groups
313395|NCT00848354|B2|Baseline|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313571|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313572|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313573|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313574|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313396|NCT00848354|B1|Baseline|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313397|NCT00848354|P2|Participant Flow|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313398|NCT00848354|P1|Participant Flow|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection subcutaneously (s.c.) once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313399|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313400|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313401|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313402|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313403|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313404|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313405|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313575|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313406|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313407|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313408|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313409|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313410|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313411|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313412|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313413|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313414|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313415|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313576|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
316977|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313416|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313417|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313418|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313419|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313420|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313421|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313422|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313423|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313424|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313425|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313577|NCT00848211|E4|Reported Event|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
316978|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313426|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313427|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313428|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313429|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313430|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313431|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313432|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313433|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313434|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313435|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313578|NCT00848211|E3|Reported Event|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
316979|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313436|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313437|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313438|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313439|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313440|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313441|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313442|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313443|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313444|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313445|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313579|NCT00848211|E2|Reported Event|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
316980|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313446|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313447|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313448|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313449|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313450|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313451|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313452|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313453|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313454|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313455|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313580|NCT00848211|E1|Reported Event|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
316981|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313456|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313457|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313458|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313459|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313460|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313461|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313462|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313463|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313464|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313465|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313581|NCT00848198|B1|Baseline|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
316982|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313466|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313467|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313468|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313469|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313470|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313471|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313472|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313473|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313474|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313475|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313582|NCT00848198|P1|Participant Flow|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
316983|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313476|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313477|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313478|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313479|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313480|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313481|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313482|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313483|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313484|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313485|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313583|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
316984|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313486|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313487|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313488|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313489|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313490|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313491|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313492|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313493|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313494|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313495|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313584|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
316985|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313496|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313497|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313498|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313499|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313500|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313501|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313502|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313503|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313504|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313505|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313585|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
314483|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
313506|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313507|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313508|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313509|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313510|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313511|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313512|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313513|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313514|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313515|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313586|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
316986|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313516|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313517|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313518|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313519|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313520|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313521|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313522|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313523|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313524|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313525|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313587|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
316987|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313526|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313527|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313528|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313529|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313530|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313531|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313532|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313533|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313534|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313535|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313588|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
314484|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
313536|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313537|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313538|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313539|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313540|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313541|NCT00848354|E6|Reported Event|DMARD + Methotrexate Phase 2 Year 2|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313542|NCT00848354|E5|Reported Event|Etanercept + Methotrexate Phase 2 Year 2|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313543|NCT00848354|E4|Reported Event|DMARD + Methotrexate Phase 2 Year 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313544|NCT00848354|E3|Reported Event|Etanercept + Methotrexate Phase 2 Year 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313545|NCT00848354|E2|Reported Event|DMARD + Methotrexate Phase 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313589|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
313546|NCT00848354|E1|Reported Event|Etanercept + Methotrexate Phase 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
313547|NCT00848237|B1|Baseline|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313548|NCT00848237|P1|Participant Flow|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313549|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313550|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313551|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313552|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313553|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313554|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313555|NCT00848237|E1|Reported Event|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
313556|NCT00848211|B5|Baseline|Total|Total of all reporting groups
313557|NCT00848211|B4|Baseline|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313558|NCT00848211|B3|Baseline|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313559|NCT00848211|B2|Baseline|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313560|NCT00848211|B1|Baseline|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313561|NCT00848211|P4|Participant Flow|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313562|NCT00848211|P3|Participant Flow|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313563|NCT00848211|P2|Participant Flow|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313564|NCT00848211|P1|Participant Flow|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313565|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313566|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313567|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313568|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313569|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313570|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
313595|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
313596|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
313597|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
313598|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
313599|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
313600|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
313601|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
313602|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
313603|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
313604|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313605|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313606|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313607|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313608|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313609|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313610|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313611|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313612|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313613|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313614|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313615|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313616|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
313617|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
313618|NCT00848198|E1|Reported Event|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
313619|NCT00848172|B3|Baseline|Total|Total of all reporting groups
313620|NCT00848172|B2|Baseline|Sequence Placebo / OA|First day: placebo Second day: octanoic acid
313621|NCT00848172|B1|Baseline|Sequence OA / Placebo|First day: octanoic acid Second day: placebo
313622|NCT00848172|P2|Participant Flow|Sequence Placebo / OA|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received Placebo on the second day of Visit 2, and a single oral dose of 4 mg/kg OA on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
313623|NCT00848172|P1|Participant Flow|Sequence OA / Placebo|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received a single oral dose of 4 mg/kg OA on the second day of Visit 2, and matching Placebo on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
313624|NCT00848172|O1|Outcome|Octanoic Acid AUC|
313625|NCT00848172|O1|Outcome|Octanoic Acid Tmax|
313626|NCT00848172|O2|Outcome|Placebo|
313627|NCT00848172|O1|Outcome|Octanoic Acid|
313628|NCT00848172|O2|Outcome|Placebo|
313629|NCT00848172|O1|Outcome|Octanoic Acid|
313630|NCT00848172|E3|Reported Event|Non-drug Related|AE was considered to be non-drug related, if no temporal connection was present between AE occurrence and drug administration (e.g. if AE occurred during the study, but prior to drug-administration), or an AE was clearly related to a study procedure (e.g. PICC line) rather than the study drug.
313631|NCT00848172|E2|Reported Event|Placebo|
313632|NCT00848172|E1|Reported Event|Octanoic Acid|
313633|NCT00848120|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313634|NCT00848120|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.
313635|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313636|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313637|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313638|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313639|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313640|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313641|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313642|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313643|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313644|NCT00848120|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
313645|NCT00848107|B1|Baseline|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313646|NCT00848107|P1|Participant Flow|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313647|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313648|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313649|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313650|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313651|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313652|NCT00848107|E1|Reported Event|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
313653|NCT00848081|B3|Baseline|Total|Total of all reporting groups
313654|NCT00848081|B2|Baseline|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313655|NCT00848081|B1|Baseline|Placebo|Placebo by mouth once daily for 12 weeks
313656|NCT00848081|P2|Participant Flow|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313657|NCT00848081|P1|Participant Flow|Placebo|Placebo by mouth once daily for 12 weeks
313658|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313659|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
313660|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313661|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
313662|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313663|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
313664|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313665|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
313666|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313667|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
313668|NCT00848081|E2|Reported Event|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
313669|NCT00848081|E1|Reported Event|Placebo|Placebo by mouth once daily for 12 weeks
313670|NCT00848042|B4|Baseline|Total|Total of all reporting groups
313671|NCT00848042|B3|Baseline|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
313672|NCT00848042|B2|Baseline|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
313673|NCT00848042|B1|Baseline|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
313674|NCT00848042|P3|Participant Flow|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
313675|NCT00848042|P2|Participant Flow|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
313676|NCT00848042|P1|Participant Flow|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
313677|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
313678|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
313679|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
313680|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
313681|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
313682|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
313683|NCT00848042|E3|Reported Event|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
313684|NCT00848042|E2|Reported Event|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
313685|NCT00848042|E1|Reported Event|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
313686|NCT00848016|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313687|NCT00848016|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313688|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313689|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313690|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313691|NCT00848016|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
313692|NCT00847886|B3|Baseline|Total|Total of all reporting groups
313693|NCT00847886|B2|Baseline|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313694|NCT00847886|B1|Baseline|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313695|NCT00847886|P2|Participant Flow|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313696|NCT00847886|P1|Participant Flow|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313697|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313698|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313699|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313700|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313701|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313702|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313703|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313704|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313705|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313706|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313707|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313708|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313709|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313710|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313711|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313712|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313713|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313714|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313715|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313716|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313717|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313718|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313719|NCT00847886|E2|Reported Event|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
313720|NCT00847886|E1|Reported Event|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
313721|NCT00847808|B1|Baseline|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313722|NCT00847808|P1|Participant Flow|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313723|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313724|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313725|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313726|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313727|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313728|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313729|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313730|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313731|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313732|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313733|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313734|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313735|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313736|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
313737|NCT00847808|E1|Reported Event|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
314188|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313738|NCT00847704|B1|Baseline|Test Group|"Device: Assisted movement and enhanced sensation~Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.~Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments."
313739|NCT00847704|P1|Participant Flow|Test Group|Device: Assisted movement and enhanced sensation
313740|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313741|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313742|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313743|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313744|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313745|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
313746|NCT00847704|E1|Reported Event|Test Treatment Group|Device: Subjects receiving AMES treatments.
313747|NCT00847665|B3|Baseline|Total|Total of all reporting groups
313748|NCT00847665|B2|Baseline|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313749|NCT00847665|B1|Baseline|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313750|NCT00847665|P2|Participant Flow|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313751|NCT00847665|P1|Participant Flow|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313752|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313753|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313754|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313755|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313756|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313757|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313758|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313759|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313760|NCT00847665|E2|Reported Event|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313761|NCT00847665|E1|Reported Event|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
313762|NCT00847626|B12|Baseline|Total|Total of all reporting groups
313763|NCT00847626|B11|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313764|NCT00847626|B10|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313765|NCT00847626|B9|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313766|NCT00847626|B8|Baseline|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313767|NCT00847626|B7|Baseline|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313768|NCT00847626|B6|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313769|NCT00847626|B5|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313770|NCT00847626|B4|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313771|NCT00847626|B3|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313772|NCT00847626|B2|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313773|NCT00847626|B1|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313774|NCT00847626|P11|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313775|NCT00847626|P10|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313776|NCT00847626|P9|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313777|NCT00847626|P8|Participant Flow|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313778|NCT00847626|P7|Participant Flow|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313779|NCT00847626|P6|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313780|NCT00847626|P5|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313781|NCT00847626|P4|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313782|NCT00847626|P3|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313783|NCT00847626|P2|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313784|NCT00847626|P1|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313785|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313786|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313787|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313788|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313789|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313790|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313791|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313792|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313793|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313794|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313795|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313796|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313797|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313798|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313799|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313800|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313801|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313802|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313803|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313804|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313805|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313806|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313807|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313808|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313809|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313810|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313811|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313812|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313813|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
316988|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
313814|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313815|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313816|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313817|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313818|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313819|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313820|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313821|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313822|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313823|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313824|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313825|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313826|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313827|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313828|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313829|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313830|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313831|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313832|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313833|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313834|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313835|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313836|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313837|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313838|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313839|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313840|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313841|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313842|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313843|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313844|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313845|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313846|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313847|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313848|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313849|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313850|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313851|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
314485|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
313852|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313853|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313854|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313855|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313856|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313857|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313858|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313859|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313860|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313861|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313862|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313863|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313864|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313865|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313866|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313867|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313868|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313869|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313870|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313871|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313872|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313873|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313874|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313875|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313876|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313877|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313878|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313879|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313880|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313881|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313882|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313883|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313884|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313885|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313886|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313887|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313888|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313889|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
314221|NCT00847613|E2|Reported Event|CP-690,550 10 mg (Up to Month 3)|Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.
313890|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313891|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313892|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313893|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313894|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313895|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313896|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313897|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313898|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313899|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313900|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313901|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313902|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313903|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313904|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313905|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313906|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313907|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313908|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313909|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313910|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313911|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313912|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313913|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313914|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313915|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313916|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313917|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313918|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313919|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313920|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313921|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313922|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313923|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313924|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313925|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313926|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313927|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
316989|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
313928|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313929|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313930|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313931|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313932|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313933|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313934|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313935|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313936|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313937|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313938|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313939|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313940|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313941|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313942|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313943|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313944|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313945|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313946|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313947|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313948|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313949|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313950|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313951|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313952|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
313953|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313954|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313955|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313956|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313957|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313958|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313959|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313960|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313961|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313962|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313963|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313964|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313965|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313966|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
313967|NCT00847626|E11|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313968|NCT00847626|E10|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313969|NCT00847626|E9|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
313970|NCT00847626|E8|Reported Event|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313971|NCT00847626|E7|Reported Event|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313972|NCT00847626|E6|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313973|NCT00847626|E5|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313974|NCT00847626|E4|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313975|NCT00847626|E3|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313976|NCT00847626|E2|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
313977|NCT00847626|E1|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
313978|NCT00847613|B5|Baseline|Total|Total of all reporting groups
313979|NCT00847613|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
313980|NCT00847613|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
313981|NCT00847613|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313982|NCT00847613|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313983|NCT00847613|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
313984|NCT00847613|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
313985|NCT00847613|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313986|NCT00847613|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313987|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
313988|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
313989|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313990|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313991|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
313992|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313993|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313994|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314222|NCT00847613|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.
313995|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
313996|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
313997|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
313998|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
313999|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314000|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314001|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314002|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314003|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314004|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314005|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314006|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314007|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314008|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314009|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314010|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314011|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314012|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314013|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314014|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314015|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314016|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314017|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314018|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314019|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314020|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314021|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314022|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314023|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314024|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314025|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314026|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314027|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314028|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314029|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314030|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314031|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314032|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314033|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314034|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314035|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314036|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314037|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314038|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314039|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314040|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314041|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314042|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314043|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314044|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314045|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314046|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314047|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314048|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314219|NCT00847613|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.
314049|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314050|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314051|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314052|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314053|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314054|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314055|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314056|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314057|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314058|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314059|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314060|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314061|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314062|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314063|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314064|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314065|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314066|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314067|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314068|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314069|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314070|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314071|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314072|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314073|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314074|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314220|NCT00847613|E3|Reported Event|Placebo (Up to Month 3)|Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.
314223|NCT00847587|B3|Baseline|Total|Total of all reporting groups
314075|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314076|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314077|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314078|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314079|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314080|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314081|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314082|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314083|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314084|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314085|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314086|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314087|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314088|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314089|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314090|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314091|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314092|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314093|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314094|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314095|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314096|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314097|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314098|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314099|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314100|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314101|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314102|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314103|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314104|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314105|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314106|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314107|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314108|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314109|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314110|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314111|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314112|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314113|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314114|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314115|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314116|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314117|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314118|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314119|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314120|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314121|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314122|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314123|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314124|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314125|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314126|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314127|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314128|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314129|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314130|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314131|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314132|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314133|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314134|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314135|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314136|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314137|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314138|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314139|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314140|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314141|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314142|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314143|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314144|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314145|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314146|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314147|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314148|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314149|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314150|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314151|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314152|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314153|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314154|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314155|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314156|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314157|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314158|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314159|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314160|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314161|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314162|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314163|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314164|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314165|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314166|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314167|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314168|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314169|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314170|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314171|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314172|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314173|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314174|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314175|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314176|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314177|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314178|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314179|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314180|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314181|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314182|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314183|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314184|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314185|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314186|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314189|NCT00847613|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314190|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314191|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314192|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314193|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314194|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314195|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314196|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
314197|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
314198|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314199|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314200|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314201|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314202|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314203|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314204|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314205|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314206|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314207|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314208|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314209|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314210|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314211|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314212|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
314213|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
314214|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
314215|NCT00847613|E8|Reported Event|CP-690,550 10 mg (Post Month 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
314216|NCT00847613|E7|Reported Event|CP-690,550 5 mg (Post Month 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.
314217|NCT00847613|E6|Reported Event|Placebo (Month 3 to 6)|Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.
314218|NCT00847613|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.
314224|NCT00847587|B2|Baseline|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
314225|NCT00847587|B1|Baseline|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
314226|NCT00847587|P2|Participant Flow|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
314227|NCT00847587|P1|Participant Flow|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
314228|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
314229|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
314230|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
314231|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
314232|NCT00847587|E2|Reported Event|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
314233|NCT00847587|E1|Reported Event|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
314234|NCT00847561|B3|Baseline|Total|Total of all reporting groups
314235|NCT00847561|B2|Baseline|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
314236|NCT00847561|B1|Baseline|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
314237|NCT00847561|P2|Participant Flow|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
314238|NCT00847561|P1|Participant Flow|Family-based CBT|"Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
314239|NCT00847561|O2|Outcome|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
314240|NCT00847561|O1|Outcome|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
314241|NCT00847561|E2|Reported Event|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
314242|NCT00847561|E1|Reported Event|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
314243|NCT00847535|B1|Baseline|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314244|NCT00847535|P3|Participant Flow|Part II: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
314245|NCT00847535|P2|Participant Flow|Part I: Periurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
314246|NCT00847535|P1|Participant Flow|Part I: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
314247|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314248|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314249|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314250|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314471|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314251|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
314252|NCT00847535|E1|Reported Event|Patients|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women
314253|NCT00847509|B1|Baseline|[F-18]FLT Scan|
314254|NCT00847509|P1|Participant Flow|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
314255|NCT00847509|O1|Outcome|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
314256|NCT00847509|E1|Reported Event|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
314257|NCT00847405|B3|Baseline|Total|Total of all reporting groups
314258|NCT00847405|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
314259|NCT00847405|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
314260|NCT00847405|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
314261|NCT00847405|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
314262|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314263|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314264|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314265|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314266|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314267|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314268|NCT00847301|B1|Baseline|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314269|NCT00847301|P1|Participant Flow|Overall Study Design|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
314270|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314271|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314272|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314273|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314274|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314275|NCT00847301|E1|Reported Event|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
314276|NCT00847288|B3|Baseline|Total|Total of all reporting groups
314277|NCT00847288|B2|Baseline|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314278|NCT00847288|B1|Baseline|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314279|NCT00847288|P2|Participant Flow|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314280|NCT00847288|P1|Participant Flow|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314281|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314282|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314283|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314284|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314285|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314286|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314287|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314288|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314472|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314289|NCT00847288|E2|Reported Event|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
314290|NCT00847288|E1|Reported Event|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
314291|NCT00847210|B3|Baseline|Total|Total of all reporting groups
314292|NCT00847210|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314293|NCT00847210|B1|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314294|NCT00847210|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314295|NCT00847210|P1|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314296|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314297|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314298|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314299|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314300|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314301|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314302|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314303|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314304|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314305|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314306|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314307|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314308|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314309|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314310|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314311|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314312|NCT00847210|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
314313|NCT00847210|E1|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
314314|NCT00847197|B3|Baseline|Total|Total of all reporting groups
314315|NCT00847197|B2|Baseline|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314316|NCT00847197|B1|Baseline|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314317|NCT00847197|P2|Participant Flow|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314318|NCT00847197|P1|Participant Flow|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314319|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314320|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314321|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314322|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314323|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314324|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314325|NCT00847197|E2|Reported Event|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314326|NCT00847197|E1|Reported Event|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
314327|NCT00847145|B9|Baseline|Total|Total of all reporting groups
314328|NCT00847145|B8|Baseline|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
314329|NCT00847145|B7|Baseline|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314330|NCT00847145|B6|Baseline|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
314331|NCT00847145|B5|Baseline|12B12M (3a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314332|NCT00847145|B4|Baseline|12M12B14B (2b)|Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314333|NCT00847145|B3|Baseline|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314334|NCT00847145|B2|Baseline|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314335|NCT00847145|B1|Baseline|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314336|NCT00847145|P8|Participant Flow|12B13M_C (4b)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
314337|NCT00847145|P7|Participant Flow|12B12M_C (4a)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314338|NCT00847145|P6|Participant Flow|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
314339|NCT00847145|P5|Participant Flow|12B12M (3a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314340|NCT00847145|P4|Participant Flow|12M12B14B (2b)|Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314341|NCT00847145|P3|Participant Flow|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314342|NCT00847145|P2|Participant Flow|12B13M (1b)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314343|NCT00847145|P1|Participant Flow|12B12M (1a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314344|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
314345|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
314346|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
314347|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
314348|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
314349|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
314350|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
314351|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
314352|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314473|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314353|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314354|NCT00847145|O4|Outcome|12B13M|Combination of Groups 12B13M (1b) and 12B13M (3b).
314355|NCT00847145|O3|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
314356|NCT00847145|O2|Outcome|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
314357|NCT00847145|O1|Outcome|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314358|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314359|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314360|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314361|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314362|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314363|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314364|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314365|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314366|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
314367|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
314368|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
314369|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
314370|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
314371|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
314372|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314373|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
314374|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
314375|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
316990|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
314376|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314377|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
314378|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314379|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314380|NCT00847145|O2|Outcome|12M13B15B (2a)|Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
314381|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
314382|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
314383|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
314384|NCT00847145|E6|Reported Event|12B13M_C (4b)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.~4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
314385|NCT00847145|E5|Reported Event|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
314386|NCT00847145|E4|Reported Event|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
314387|NCT00847145|E3|Reported Event|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
314388|NCT00847145|E2|Reported Event|12B13M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.~This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes."
314389|NCT00847145|E1|Reported Event|12B12M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes."
314390|NCT00845481|B1|Baseline|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
314391|NCT00845481|P1|Participant Flow|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
314392|NCT00845481|O1|Outcome|Patients Treated With Diprosalic Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Diprosalic ointment
314393|NCT00845481|O1|Outcome|Patients Treated With Dermovat Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Dermovat ointment
314394|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment Vehicle|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® Ointment vehicle
314395|NCT00845481|O1|Outcome|Patients Treated With Elocon Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Elocon ointment
314396|NCT00845481|O1|Outcome|Patients Treated With Betnovat® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Betnovat® ointment
314397|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
314398|NCT00845481|E1|Reported Event|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
314474|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314399|NCT00847015|B1|Baseline|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314400|NCT00847015|P1|Participant Flow|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314401|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314402|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314403|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314404|NCT00847015|E1|Reported Event|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
314405|NCT00847002|B3|Baseline|Total|Total of all reporting groups
314406|NCT00847002|B2|Baseline|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
314407|NCT00847002|B1|Baseline|Standard of Care Wound Treatment|Standard Wound Care using compression
314408|NCT00847002|P2|Participant Flow|Flexitouch System|Flexitouch system with Standard Wound Care using compression
314409|NCT00847002|P1|Participant Flow|Standard of Care|Standard Wound Care using compression
314410|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
314411|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
314412|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
314413|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
314414|NCT00847002|E2|Reported Event|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
314415|NCT00847002|E1|Reported Event|Standard of Care Wound Treatment|Standard Wound Care using compression
314416|NCT00846885|B3|Baseline|Total|Total of all reporting groups
314417|NCT00846885|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
314418|NCT00846885|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
314419|NCT00846885|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
314420|NCT00846885|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
314421|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314422|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314423|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314424|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314425|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
314426|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
314475|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314427|NCT00846846|B1|Baseline|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
314428|NCT00846846|P1|Participant Flow|Endeavor® Zotarolimus Eluting Coronary Stent System|"Endeavor® Zotarolimus Eluting Coronary Stent System >~> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation"
314429|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
314430|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
314431|NCT00846846|E1|Reported Event|Endeavor|Medtronic Endeavor
314432|NCT00846807|B1|Baseline|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314433|NCT00846807|P1|Participant Flow|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314434|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314435|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314436|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314437|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314438|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314439|NCT00846807|E1|Reported Event|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
314440|NCT00846768|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.
314441|NCT00846768|P4|Participant Flow|Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
314442|NCT00846768|P3|Participant Flow|Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid|Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
314443|NCT00846768|P2|Participant Flow|Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
314444|NCT00846768|P1|Participant Flow|Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid|Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
314445|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314446|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314447|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314448|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314449|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314450|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314451|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314452|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314453|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314454|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314455|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314456|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314457|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314458|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314459|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314460|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314461|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314462|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314463|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314464|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314465|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314466|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314467|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314468|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314469|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314470|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314486|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314487|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314488|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314489|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314490|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314491|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314492|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314493|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314494|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314495|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314496|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314497|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314498|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314499|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314500|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314501|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314502|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314503|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314504|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314505|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314506|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314507|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314508|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314509|NCT00846768|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
314510|NCT00846768|E3|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
314511|NCT00846768|E2|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
314512|NCT00846768|E1|Reported Event|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
314513|NCT00846651|B3|Baseline|Total|Total of all reporting groups
314514|NCT00846651|B2|Baseline|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314515|NCT00846651|B1|Baseline|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314516|NCT00846651|P2|Participant Flow|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314517|NCT00846651|P1|Participant Flow|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314518|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314519|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314520|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314521|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314522|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314523|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314524|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314525|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314598|NCT00846391|B1|Baseline|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
314526|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314527|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314528|NCT00846651|E2|Reported Event|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314529|NCT00846651|E1|Reported Event|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
314530|NCT00846586|B3|Baseline|Total|Total of all reporting groups
314531|NCT00846586|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314532|NCT00846586|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314533|NCT00846586|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314534|NCT00846586|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314535|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314536|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314537|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314538|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314539|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314540|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314576|NCT00846495|P1|Participant Flow|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314541|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314542|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314543|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314544|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314545|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314546|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314547|NCT00846586|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314548|NCT00846586|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
314549|NCT00846573|B4|Baseline|Total|Total of all reporting groups
314550|NCT00846573|B3|Baseline|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314551|NCT00846573|B2|Baseline|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
314552|NCT00846573|B1|Baseline|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314553|NCT00846573|P4|Participant Flow|Healthy|"This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314554|NCT00846573|P3|Participant Flow|Cystic Fibrosis|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314555|NCT00846573|P2|Participant Flow|Asthma|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
314556|NCT00846573|P1|Participant Flow|COPD|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314557|NCT00846573|O3|Outcome|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314558|NCT00846573|O2|Outcome|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
314559|NCT00846573|O1|Outcome|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314560|NCT00846573|E3|Reported Event|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314561|NCT00846573|E2|Reported Event|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
314562|NCT00846573|E1|Reported Event|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
314563|NCT00846547|B1|Baseline|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
314564|NCT00846547|P1|Participant Flow|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
314565|NCT00846547|O1|Outcome|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
314566|NCT00846547|E1|Reported Event|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
314567|NCT00846521|B1|Baseline|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
314568|NCT00846521|P1|Participant Flow|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
314569|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
314570|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
314571|NCT00846521|E1|Reported Event|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
314572|NCT00846495|B3|Baseline|Total|Total of all reporting groups
314573|NCT00846495|B2|Baseline|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314574|NCT00846495|B1|Baseline|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314575|NCT00846495|P2|Participant Flow|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314577|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314578|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314579|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314580|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314581|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314582|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314583|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314584|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314585|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314586|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314587|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314588|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314589|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314590|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314591|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314592|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314593|NCT00846495|E2|Reported Event|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
314594|NCT00846495|E1|Reported Event|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
314595|NCT00846391|B4|Baseline|Total|Total of all reporting groups
314596|NCT00846391|B3|Baseline|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
314597|NCT00846391|B2|Baseline|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
314599|NCT00846391|P3|Participant Flow|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
314600|NCT00846391|P2|Participant Flow|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
314601|NCT00846391|P1|Participant Flow|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
314602|NCT00846391|O3|Outcome|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
314603|NCT00846391|O2|Outcome|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
314604|NCT00846391|O1|Outcome|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
314605|NCT00846391|E3|Reported Event|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
314606|NCT00846391|E2|Reported Event|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
314607|NCT00846391|E1|Reported Event|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
314608|NCT00846365|B4|Baseline|Total|Total of all reporting groups
314609|NCT00846365|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314610|NCT00846365|B2|Baseline|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314611|NCT00846365|B1|Baseline|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314612|NCT00846365|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314613|NCT00846365|P2|Participant Flow|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314614|NCT00846365|P1|Participant Flow|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314615|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314616|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314617|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314618|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314619|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314683|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
314684|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
314620|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314621|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314622|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314623|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314624|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314625|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314626|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314627|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314628|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314629|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314630|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314631|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314632|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314633|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314634|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314635|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314685|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
314636|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314637|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314638|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314639|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314640|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314641|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314642|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314643|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314644|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314645|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314646|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314647|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314648|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314649|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314650|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314651|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314686|NCT00846066|O2|Outcome|WBT + HOT|Web Based Training plus Hands on Training
314652|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314653|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314654|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314655|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314656|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314657|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314658|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314659|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314660|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314661|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314662|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314663|NCT00846365|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314664|NCT00846365|E2|Reported Event|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314665|NCT00846365|E1|Reported Event|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
314666|NCT00846287|B3|Baseline|Total|Total of all reporting groups
314667|NCT00846287|B2|Baseline|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314668|NCT00846287|B1|Baseline|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314669|NCT00846287|P2|Participant Flow|Active Comparator: Drug Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314670|NCT00846287|P1|Participant Flow|Active Comparator: Saline|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314671|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314672|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
314673|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314674|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
314675|NCT00846287|E2|Reported Event|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314676|NCT00846287|E1|Reported Event|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
314677|NCT00846066|B3|Baseline|Total|Total of all reporting groups
314678|NCT00846066|B2|Baseline|WBT+HOT|Web Based Training plus Hands on Training
314679|NCT00846066|B1|Baseline|WBT Only|Control Group Web Based Training only
314680|NCT00846066|P2|Participant Flow|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
314681|NCT00846066|P1|Participant Flow|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
314682|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
314687|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
314688|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
314689|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
314690|NCT00846066|E2|Reported Event|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
314691|NCT00846066|E1|Reported Event|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
314692|NCT00846027|B1|Baseline|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314693|NCT00846027|P1|Participant Flow|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314694|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314695|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314696|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314697|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314698|NCT00846027|E1|Reported Event|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
314699|NCT00845975|B3|Baseline|Total|Total of all reporting groups
314700|NCT00845975|B2|Baseline|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314701|NCT00845975|B1|Baseline|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314702|NCT00845975|P2|Participant Flow|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314703|NCT00845975|P1|Participant Flow|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314704|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314705|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314706|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314707|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314708|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314709|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314710|NCT00845975|E2|Reported Event|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
314711|NCT00845975|E1|Reported Event|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
314712|NCT00845897|B4|Baseline|Total|Total of all reporting groups
314713|NCT00845897|B3|Baseline|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
314714|NCT00845897|B2|Baseline|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
314715|NCT00845897|B1|Baseline|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
314716|NCT00845897|P3|Participant Flow|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
314717|NCT00845897|P2|Participant Flow|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
314718|NCT00845897|P1|Participant Flow|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
314719|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
314720|NCT00845897|O2|Outcome|Placebo|Saline
314721|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
314722|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
314723|NCT00845897|O2|Outcome|Placebo|Saline
314724|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
314725|NCT00845897|E3|Reported Event|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
314726|NCT00845897|E2|Reported Event|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
314727|NCT00845897|E1|Reported Event|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
314728|NCT00845858|B4|Baseline|Total|Total of all reporting groups
314729|NCT00845858|B3|Baseline|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
314730|NCT00845858|B2|Baseline|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314731|NCT00845858|B1|Baseline|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314732|NCT00845858|P3|Participant Flow|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
314733|NCT00845858|P2|Participant Flow|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314734|NCT00845858|P1|Participant Flow|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314735|NCT00845858|O3|Outcome|Female-Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
314736|NCT00845858|O2|Outcome|Female-Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314737|NCT00845858|O1|Outcome|Female-Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314738|NCT00845858|O3|Outcome|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
314739|NCT00845858|O2|Outcome|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314740|NCT00845858|O1|Outcome|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314741|NCT00845858|E3|Reported Event|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
314742|NCT00845858|E2|Reported Event|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314743|NCT00845858|E1|Reported Event|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
314744|NCT00845845|B3|Baseline|Total|Total of all reporting groups
314745|NCT00845845|B2|Baseline|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
314746|NCT00845845|B1|Baseline|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
314747|NCT00845845|P2|Participant Flow|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
314748|NCT00845845|P1|Participant Flow|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
314749|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
314750|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
314751|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
314752|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
314753|NCT00845845|E2|Reported Event|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
315005|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
314754|NCT00845845|E1|Reported Event|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
314755|NCT00845832|B4|Baseline|Total|Total of all reporting groups
314756|NCT00845832|B3|Baseline|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314757|NCT00845832|B2|Baseline|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314758|NCT00845832|B1|Baseline|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314759|NCT00845832|P3|Participant Flow|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314760|NCT00845832|P2|Participant Flow|Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314761|NCT00845832|P1|Participant Flow|Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314762|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314763|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314764|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314765|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314766|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314767|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314768|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314769|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314770|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314771|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314772|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314773|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314774|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314775|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314776|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314777|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314778|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314779|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314780|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314781|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314782|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314783|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314784|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314785|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314786|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314787|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314788|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314789|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314790|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314791|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314792|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314793|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314794|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314795|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314796|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314797|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314798|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314799|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314800|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314801|NCT00845832|E3|Reported Event|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314802|NCT00845832|E2|Reported Event|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314803|NCT00845832|E1|Reported Event|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
314804|NCT00845728|B3|Baseline|Total|Total of all reporting groups
314805|NCT00845728|B2|Baseline|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
314806|NCT00845728|B1|Baseline|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
314807|NCT00845728|P2|Participant Flow|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
314808|NCT00845728|P1|Participant Flow|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
314809|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
314810|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
314811|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
314812|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
314813|NCT00845728|E2|Reported Event|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
316991|NCT00839241|E2|Reported Event|Allogenic Blood Transfusion|
314814|NCT00845728|E1|Reported Event|IndIndacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
314815|NCT00845702|B1|Baseline|TOF and Dotarem Enhanced MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
314816|NCT00845702|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
314817|NCT00845702|O2|Outcome|Time Of Flight MRA|Each subject will undergo a TOF MRA
314818|NCT00845702|O1|Outcome|Dotarem MRA|Each subject will receive one injection of Dotarem 0.2 ml/kg.
314819|NCT00845702|E2|Reported Event|Time Of Flight MRA|Subjects undergo a TOF MRA
314820|NCT00845702|E1|Reported Event|Dotarem Magnetic Resonance Angiography|Each subject will receive one injection of Dotarem 0.2 ml/kg.
314821|NCT00845676|B1|Baseline|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
314822|NCT00845676|P1|Participant Flow|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
314823|NCT00845676|O1|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
314824|NCT00845676|E1|Reported Event|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
314825|NCT00845663|B3|Baseline|Total|Total of all reporting groups
314826|NCT00845663|B2|Baseline|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314827|NCT00845663|B1|Baseline|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314828|NCT00845663|P2|Participant Flow|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314829|NCT00845663|P1|Participant Flow|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314830|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314831|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314832|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314833|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314834|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314835|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314836|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314837|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314838|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314839|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314840|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314841|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314842|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314843|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314844|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
315408|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
314845|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314846|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314847|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314848|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314849|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314850|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314851|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314852|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314853|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314854|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314855|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314856|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314857|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314858|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314859|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314860|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314861|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314862|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314863|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314864|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314865|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314866|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314867|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314868|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314869|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314870|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314871|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314872|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314873|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314874|NCT00845663|E2|Reported Event|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314875|NCT00845663|E1|Reported Event|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
314876|NCT00845429|B4|Baseline|Total|Total of all reporting groups
314877|NCT00845429|B3|Baseline|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314878|NCT00845429|B2|Baseline|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314879|NCT00845429|B1|Baseline|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314880|NCT00845429|P3|Participant Flow|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314881|NCT00845429|P2|Participant Flow|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314882|NCT00845429|P1|Participant Flow|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314883|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314884|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314885|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314886|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314887|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314888|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314889|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314890|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314891|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314892|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314893|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314894|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314895|NCT00845429|E3|Reported Event|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
314896|NCT00845429|E2|Reported Event|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
314897|NCT00845429|E1|Reported Event|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
314898|NCT00845195|B3|Baseline|Total|Total of all reporting groups
314899|NCT00845195|B2|Baseline|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314900|NCT00845195|B1|Baseline|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314901|NCT00845195|P2|Participant Flow|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314902|NCT00845195|P1|Participant Flow|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314903|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314904|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314905|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314906|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314907|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314908|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314909|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314910|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314911|NCT00845195|E2|Reported Event|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
314912|NCT00845195|E1|Reported Event|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
314913|NCT00845182|B4|Baseline|Total|Total of all reporting groups
314914|NCT00845182|B3|Baseline|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
314915|NCT00845182|B2|Baseline|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
314916|NCT00845182|B1|Baseline|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
314917|NCT00845182|P3|Participant Flow|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
314918|NCT00845182|P2|Participant Flow|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
314919|NCT00845182|P1|Participant Flow|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
315006|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314920|NCT00845182|O3|Outcome|Drug Pioglitazone and Drug Exentatide|"Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide~Pioglitazone and Exenatide: Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months"
314921|NCT00845182|O2|Outcome|Exenatide|"Exenatide: 15 subjects will be randomized to receive Exenatide~Exenatide: Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months"
314922|NCT00845182|O1|Outcome|Pioglitazone|"Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm~Pioglitazone: Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months"
314923|NCT00845182|O3|Outcome|PIOGLITAZONE and EXNATIDE|Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
314924|NCT00845182|O2|Outcome|EXENATIDE|PIO therapy led to a weigh loss of 2.4 kg
314925|NCT00845182|O1|Outcome|PIOGLITAZONE|PIO therapy led to a weigh gain of 5.5 kg
314926|NCT00845182|E3|Reported Event|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
314927|NCT00845182|E2|Reported Event|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
314928|NCT00845182|E1|Reported Event|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
314929|NCT00845130|B3|Baseline|Total|Total of all reporting groups
314930|NCT00845130|B2|Baseline|Health Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314931|NCT00845130|B1|Baseline|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314932|NCT00845130|P2|Participant Flow|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314933|NCT00845130|P1|Participant Flow|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314934|NCT00845130|O2|Outcome|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314935|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314936|NCT00845130|O2|Outcome|Healthy Subjects|Vitamin C levels in the living brain.
314937|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Vitamin C level in the living brain
314938|NCT00845130|E2|Reported Event|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314939|NCT00845130|E1|Reported Event|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
314940|NCT00845065|B3|Baseline|Total|Total of all reporting groups
314941|NCT00845065|B2|Baseline|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314942|NCT00845065|B1|Baseline|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314943|NCT00845065|P2|Participant Flow|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314944|NCT00845065|P1|Participant Flow|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314945|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314946|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314947|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314948|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314949|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314950|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314951|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
315007|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
315008|NCT00844896|E2|Reported Event|DEF + COPE|28 subjects in this arm of the study.
314952|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314953|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314954|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314955|NCT00845065|E2|Reported Event|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
314956|NCT00845065|E1|Reported Event|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
314957|NCT00845000|B7|Baseline|Total|Total of all reporting groups
314958|NCT00845000|B6|Baseline|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314959|NCT00845000|B5|Baseline|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314960|NCT00845000|B4|Baseline|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314961|NCT00845000|B3|Baseline|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314962|NCT00845000|B2|Baseline|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314963|NCT00845000|B1|Baseline|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314964|NCT00845000|P6|Participant Flow|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314965|NCT00845000|P5|Participant Flow|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314966|NCT00845000|P4|Participant Flow|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
315009|NCT00844896|E1|Reported Event|DEF-only|29 subjects in this arm of the study.
315010|NCT00844857|B3|Baseline|Total|Total of all reporting groups
315011|NCT00844857|B2|Baseline|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
314967|NCT00845000|P3|Participant Flow|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314968|NCT00845000|P2|Participant Flow|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314969|NCT00845000|P1|Participant Flow|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
314970|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
314971|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
314972|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
314973|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
314974|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
314975|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
314976|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
314977|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
314978|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
314979|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
314980|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
314981|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
314982|NCT00845000|E3|Reported Event|Placebo|Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
314983|NCT00845000|E2|Reported Event|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
314984|NCT00845000|E1|Reported Event|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
314985|NCT00844896|B3|Baseline|Total|Total of all reporting groups
314986|NCT00844896|B2|Baseline|DEF + COPE|28 subjects in this arm of the study.
314987|NCT00844896|B1|Baseline|DEF-only|29 subjects in this arm of the study.
314988|NCT00844896|P2|Participant Flow|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314989|NCT00844896|P1|Participant Flow|DEF-only|Distress Emotional Support and Family Assessment Treatment
314990|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314991|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
314992|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314993|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
314994|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314995|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
314996|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment.
314997|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
314998|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
314999|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
315000|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
315001|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
315002|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
315003|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
315004|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
315012|NCT00844857|B1|Baseline|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315013|NCT00844857|P2|Participant Flow|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315014|NCT00844857|P1|Participant Flow|Olanzapine/Fluoxetine Combination|Olanzapine/fluoxetine Combination (OFC) 3 milligrams (mg) olanzapine and 25 mg fluoxetine (OFC 3/25) administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315015|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315016|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315017|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315018|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315019|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315020|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315021|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315022|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
315023|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315024|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315025|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315026|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315027|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315028|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
315029|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315030|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
315031|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315032|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315033|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315034|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315035|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315036|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315037|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315081|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315038|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315039|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315040|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315041|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315042|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315043|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315044|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
315045|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315046|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315047|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315048|NCT00844857|O1|Outcome|Olanzapine Plus Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315049|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315050|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315051|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315052|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315053|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally, once daily for 8 weeks.
315054|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315055|NCT00844857|E2|Reported Event|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
315056|NCT00844857|E1|Reported Event|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
315057|NCT00844844|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315058|NCT00844844|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315059|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315060|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315409|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315061|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315062|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315063|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315064|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315065|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315066|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315067|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315068|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315069|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315070|NCT00844844|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315071|NCT00844805|B3|Baseline|Total|Total of all reporting groups
315072|NCT00844805|B2|Baseline|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315073|NCT00844805|B1|Baseline|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315074|NCT00844805|P4|Participant Flow|No Treatment|For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315075|NCT00844805|P3|Participant Flow|Naproxen|For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315076|NCT00844805|P2|Participant Flow|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315077|NCT00844805|P1|Participant Flow|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315078|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315079|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315080|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
316992|NCT00839241|E1|Reported Event|Autologous Blood Transfusion|
315082|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315083|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315084|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315085|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315086|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315087|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315088|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315089|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315090|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315091|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315092|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315093|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315094|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315095|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315096|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315097|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315098|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315099|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315100|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315101|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315102|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315103|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315104|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315105|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315106|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315107|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315108|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315109|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315110|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315111|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
315112|NCT00844805|E4|Reported Event|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
315113|NCT00844805|E3|Reported Event|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
315114|NCT00844805|E2|Reported Event|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
315115|NCT00844805|E1|Reported Event|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
315116|NCT00844753|B5|Baseline|Total|Total of all reporting groups
315117|NCT00844753|B4|Baseline|Placebo Without Parent Management Training|Sugar pill administered twice daily.
315118|NCT00844753|B3|Baseline|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315119|NCT00844753|B2|Baseline|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
315120|NCT00844753|B1|Baseline|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315121|NCT00844753|P4|Participant Flow|Placebo Without Parent Management Training|Sugar pill administered twice daily.
315122|NCT00844753|P3|Participant Flow|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315123|NCT00844753|P2|Participant Flow|Atomoxetine (ATX) Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
315124|NCT00844753|P1|Participant Flow|Atomoxetine (ATX) + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315125|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
315126|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315127|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
315150|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315151|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315410|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315128|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315129|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
315130|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315131|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
315132|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
315133|NCT00844753|E2|Reported Event|Placebo|Data includes the placebo alone arm and the placebo+parent therapy arm
315134|NCT00844753|E1|Reported Event|Atomoxetine|Data includes both the ATX alone arm and the ATX+ parent therapy arm
315135|NCT00844714|B1|Baseline|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
315136|NCT00844714|P1|Participant Flow|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
315137|NCT00844714|O1|Outcome|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
315138|NCT00844714|E1|Reported Event|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
315139|NCT00844649|B3|Baseline|Total|Total of all reporting groups
315140|NCT00844649|B2|Baseline|Gemcitabine|"Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).~Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)."
315141|NCT00844649|B1|Baseline|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|"ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.~Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest"
315142|NCT00844649|P2|Participant Flow|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315143|NCT00844649|P1|Participant Flow|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315144|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315145|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315146|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315147|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315148|NCT00844649|O2|Outcome|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315149|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315411|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315152|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315153|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315154|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315155|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315156|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315157|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315158|NCT00844649|E2|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
315159|NCT00844649|E1|Reported Event|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
315160|NCT00844597|B7|Baseline|Total|Total of all reporting groups
315161|NCT00844597|B6|Baseline|Cohort 6 - 20.0mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315162|NCT00844597|B5|Baseline|Cohort 5 - 10.0mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315163|NCT00844597|B4|Baseline|Cohort 4 - 4.0mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315164|NCT00844597|B3|Baseline|Cohort 3 - 2.0mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315165|NCT00844597|B2|Baseline|Cohort 2 - 1.0mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315166|NCT00844597|B1|Baseline|Cohort 1 - 0.5mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315167|NCT00844597|P6|Participant Flow|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315168|NCT00844597|P5|Participant Flow|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315169|NCT00844597|P4|Participant Flow|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315170|NCT00844597|P3|Participant Flow|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315171|NCT00844597|P2|Participant Flow|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315172|NCT00844597|P1|Participant Flow|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
315173|NCT00844597|O6|Outcome|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315174|NCT00844597|O5|Outcome|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315175|NCT00844597|O4|Outcome|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315176|NCT00844597|O3|Outcome|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315177|NCT00844597|O2|Outcome|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315178|NCT00844597|O1|Outcome|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315179|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
315226|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315180|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
315181|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
315182|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
315183|NCT00844597|E6|Reported Event|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315184|NCT00844597|E5|Reported Event|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315185|NCT00844597|E4|Reported Event|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315186|NCT00844597|E3|Reported Event|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315187|NCT00844597|E2|Reported Event|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315188|NCT00844597|E1|Reported Event|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
315189|NCT00844558|B3|Baseline|Total|Total of all reporting groups
315190|NCT00844558|B2|Baseline|Control|The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
315191|NCT00844558|B1|Baseline|Gait|The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
315192|NCT00844558|P2|Participant Flow|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
315193|NCT00844558|P1|Participant Flow|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
315194|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
315195|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
315196|NCT00844558|O2|Outcome|Control|"Gait Training Control Group Participants~Control: There is no intervention associated with this arm of the study"
315197|NCT00844558|O1|Outcome|Gait Training|"Gait Training Intervention Group Participants~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
315198|NCT00844558|O2|Outcome|Control|No adverse events
315199|NCT00844558|O1|Outcome|Gait|No adverse events
315200|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
315201|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
315202|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
315203|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
315204|NCT00844558|O2|Outcome|Control Group|No adverse events
315205|NCT00844558|O1|Outcome|Gait|No adverse events
315206|NCT00844558|E2|Reported Event|Control|Usual care for symptomatic knee OA through their usual healthcare providers and were not asked to make changes in their lifestyle. Usual care may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery and/or physical therapy.
315207|NCT00844558|E1|Reported Event|Gait|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
315208|NCT00844545|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315209|NCT00844545|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315210|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315211|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315212|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315213|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315214|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315215|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315216|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315217|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315218|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315219|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315220|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
315221|NCT00844545|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315222|NCT00844532|B1|Baseline|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315223|NCT00844532|P1|Participant Flow|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315224|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315225|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315395|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315227|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315228|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315229|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315230|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315231|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315232|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315233|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315234|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315235|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315236|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315237|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315238|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315239|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315240|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315241|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315242|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315243|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315244|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315245|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315246|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315247|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315396|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315397|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315248|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315249|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315250|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315251|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315252|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315253|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315254|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315255|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315256|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315257|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315258|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315259|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315260|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315261|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315262|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315263|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315264|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315265|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315266|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315267|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315268|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315398|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315399|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315269|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315270|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315271|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315272|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315273|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315274|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315275|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315276|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315277|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315278|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315279|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315280|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315281|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315282|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315283|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315284|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315285|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315286|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315287|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315288|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315289|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315400|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315401|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315290|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315291|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315292|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315293|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315294|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315295|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315296|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315297|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315298|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315299|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315300|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315301|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315302|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315303|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315304|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315305|NCT00844532|E1|Reported Event|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
315306|NCT00844519|B3|Baseline|Total|Total of all reporting groups
315307|NCT00844519|B2|Baseline|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
315308|NCT00844519|B1|Baseline|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
315309|NCT00844519|P2|Participant Flow|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
315310|NCT00844519|P1|Participant Flow|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
315311|NCT00844519|O2|Outcome|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
315312|NCT00844519|O1|Outcome|Maraviroc|maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
315313|NCT00844519|E2|Reported Event|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
315314|NCT00844519|E1|Reported Event|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
315402|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315403|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315315|NCT00844428|B1|Baseline|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315316|NCT00844428|P1|Participant Flow|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315317|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315318|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315319|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315320|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315321|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315322|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315323|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315324|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315325|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315326|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315327|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315328|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315404|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315405|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315406|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315329|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315330|NCT00844428|E1|Reported Event|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
315331|NCT00844415|B1|Baseline|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315332|NCT00844415|P1|Participant Flow|All Patients (Pat.)|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315333|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315334|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315335|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315336|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315337|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315338|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315407|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315339|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315340|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315341|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
315342|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315343|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315344|NCT00844415|E1|Reported Event|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
315345|NCT00844376|B1|Baseline|All Participants|
315346|NCT00844376|P2|Participant Flow|Reference Drug First (Atorvastatin Tablet)|80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1.
315347|NCT00844376|P1|Participant Flow|Test Drug First (Atorvastatin EP Suspension)|80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1.
315348|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315349|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315350|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315351|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315352|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315353|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315354|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315355|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315356|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315357|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315358|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315359|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315360|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315361|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
315362|NCT00844376|E2|Reported Event|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
315363|NCT00844376|E1|Reported Event|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
316261|NCT00841776|E1|Reported Event|Duac|Clindamycin and benzoyl peroxide topical gel
315364|NCT00844298|B1|Baseline|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
315365|NCT00844298|P1|Participant Flow|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
315366|NCT00844298|O1|Outcome|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
315367|NCT00844298|E1|Reported Event|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
315368|NCT00844194|B3|Baseline|Total|Total of all reporting groups
315369|NCT00844194|B2|Baseline|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315370|NCT00844194|B1|Baseline|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315371|NCT00844194|P2|Participant Flow|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315372|NCT00844194|P1|Participant Flow|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315373|NCT00844194|O4|Outcome|MDD+ Non-Responder|MDD+, not treatment responder. 60mg, after week 5 120mg DLX
315374|NCT00844194|O3|Outcome|MDD- Non-Responder|MDD-, not treatment responder. 60mg, after week 5 120mg DLX
315375|NCT00844194|O2|Outcome|MDD+ Responder|MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
315376|NCT00844194|O1|Outcome|MDD- Responder|MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
315377|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315378|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315379|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315380|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315381|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315382|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315383|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315384|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315385|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315386|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315387|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315388|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315389|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315390|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315391|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315392|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315393|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315394|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
316262|NCT00841763|B3|Baseline|Total|Total of all reporting groups
315412|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315413|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315414|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315415|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315416|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315417|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315418|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315419|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315420|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315421|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315422|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315423|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315424|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315425|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315426|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315427|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315428|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315429|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315430|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315431|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315432|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315433|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315434|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315435|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315436|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315437|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315438|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315439|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315440|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315441|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315442|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315443|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315444|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315445|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315446|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315447|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315448|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315449|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315450|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315451|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315452|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315453|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315454|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315455|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315456|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315457|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315458|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315459|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315460|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315461|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315462|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315463|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315464|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
316993|NCT00839098|B4|Baseline|Total|Total of all reporting groups
315465|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315466|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315467|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315468|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315469|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315470|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315471|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315472|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315473|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315474|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315475|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315476|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315477|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315478|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315479|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315480|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315481|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315482|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315483|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315484|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315485|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315486|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315487|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315488|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315489|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315490|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315491|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315492|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315493|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315494|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315495|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315496|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315497|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315498|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315499|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315500|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315501|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315502|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315503|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315504|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315505|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315506|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315507|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315508|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315509|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315510|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315511|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315512|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315513|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315514|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315515|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315516|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315517|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
318929|NCT00834587|B3|Baseline|Total|Total of all reporting groups
315518|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315519|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315520|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315521|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315522|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315523|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315524|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315525|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315526|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315527|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315528|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315529|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315530|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315531|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315532|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315533|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315534|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315535|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315536|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315537|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315538|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315539|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315540|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315541|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315542|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315543|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315544|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315545|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315546|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315547|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315548|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315549|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315550|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315551|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315552|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315553|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315554|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315555|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315556|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315557|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315558|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315559|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315560|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315561|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315562|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315563|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315564|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315565|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315566|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315567|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315568|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315569|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315570|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
319034|NCT00834405|B3|Baseline|Total|Total of all reporting groups
315571|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315572|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315573|NCT00844194|E2|Reported Event|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
315574|NCT00844194|E1|Reported Event|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
315575|NCT00844090|B3|Baseline|Total|Total of all reporting groups
315576|NCT00844090|B2|Baseline|Placebo|"placebo~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315577|NCT00844090|B1|Baseline|Methylphenidate|"methylphenidate~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315578|NCT00844090|P2|Participant Flow|Placebo|"placebo~placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315579|NCT00844090|P1|Participant Flow|Methylphenidate|"methylphenidate~methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315580|NCT00844090|O2|Outcome|Placebo|"placebo~Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315581|NCT00844090|O1|Outcome|Methylphenidate|"methylphenidate~methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315582|NCT00844090|E2|Reported Event|Placebo|"placebo~Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315583|NCT00844090|E1|Reported Event|Methyphenidate|"methylphenidate~methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
315584|NCT00844051|B3|Baseline|Total|Total of all reporting groups
315585|NCT00844051|B2|Baseline|Intervention|"School-based Influenza Vaccination Program~School-based influenza vaccination program: School-based influenza vaccination program"
315586|NCT00844051|B1|Baseline|No Intervention|No school-based influenza vaccination program
315587|NCT00844051|P2|Participant Flow|Intervention|School-based Influenza Vaccination Program
315588|NCT00844051|P1|Participant Flow|No Intervention|No school-based influenza vaccination program
315589|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
315590|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
315591|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
315592|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
315593|NCT00844051|E2|Reported Event|Intervention|School-based Influenza Vaccination Program
315594|NCT00844051|E1|Reported Event|No Intervention|No school-based influenza vaccination program
315595|NCT00843986|B3|Baseline|Total|Total of all reporting groups
315596|NCT00843986|B2|Baseline|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315597|NCT00843986|B1|Baseline|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315598|NCT00843986|P2|Participant Flow|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315599|NCT00843986|P1|Participant Flow|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315600|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315601|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315602|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315603|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315604|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315605|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315606|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315607|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315608|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315609|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315610|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315611|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315612|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315613|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315614|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315615|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315616|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315617|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315618|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315619|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315620|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315621|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315622|NCT00843986|E2|Reported Event|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
315623|NCT00843986|E1|Reported Event|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
315624|NCT00843843|B3|Baseline|Total|Total of all reporting groups
315625|NCT00843843|B2|Baseline|3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
315626|NCT00843843|B1|Baseline|9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
315627|NCT00843843|P2|Participant Flow|3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)|3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
315628|NCT00843843|P1|Participant Flow|9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)|9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
315629|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
315630|NCT00843843|O1|Outcome|9 Hour Sleep|
315631|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
315632|NCT00843843|O1|Outcome|9 Hour Sleep|
315633|NCT00843843|E2|Reported Event|3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
315634|NCT00843843|E1|Reported Event|9 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
315635|NCT00843830|B1|Baseline|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
315636|NCT00843830|P1|Participant Flow|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
315637|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
315638|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
315639|NCT00843830|E1|Reported Event|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
315640|NCT00843778|B1|Baseline|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315641|NCT00843778|P1|Participant Flow|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315642|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315685|NCT00843635|B1|Baseline|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
319035|NCT00834405|B2|Baseline|Arava®|Arava® 20 mg Tablet
315643|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315644|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315645|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315646|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315647|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315648|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315649|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315650|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315651|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315652|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315653|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315654|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315686|NCT00843635|P3|Participant Flow|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315687|NCT00843635|P2|Participant Flow|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
319036|NCT00834405|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
315655|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315656|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315657|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315658|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315659|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315660|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315661|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315662|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315663|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315664|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315665|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315666|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315688|NCT00843635|P1|Participant Flow|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315689|NCT00843635|O3|Outcome|Arm C - Placebo|Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
316335|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
315667|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315668|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315669|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315670|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315671|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
315672|NCT00843778|E1|Reported Event|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
315673|NCT00843713|B3|Baseline|Total|Total of all reporting groups
315674|NCT00843713|B2|Baseline|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315675|NCT00843713|B1|Baseline|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315676|NCT00843713|P2|Participant Flow|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315677|NCT00843713|P1|Participant Flow|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315678|NCT00843713|O2|Outcome|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315679|NCT00843713|O1|Outcome|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315680|NCT00843713|E2|Reported Event|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315681|NCT00843713|E1|Reported Event|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
315682|NCT00843635|B4|Baseline|Total|Total of all reporting groups
315683|NCT00843635|B3|Baseline|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315684|NCT00843635|B2|Baseline|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315690|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
315691|NCT00843635|O1|Outcome|Arm A - 10mg|Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
315692|NCT00843635|O1|Outcome|Arm A (Tadalafil 10mg) + Arm B (Tadalafil 20mg)|All participants enrolled to the two dosing arms, Arm A (Tadalafil 10 mg) and Arm B (Tadalafil 20 mg).
315693|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315694|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315695|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315696|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315697|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315698|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315699|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315700|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315701|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315702|NCT00843635|E3|Reported Event|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
315703|NCT00843635|E2|Reported Event|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315704|NCT00843635|E1|Reported Event|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
315705|NCT00843622|B3|Baseline|Total|Total of all reporting groups
315706|NCT00843622|B2|Baseline|Placebo Snus|Non-tobacco, non-nicotine placebo product
315707|NCT00843622|B1|Baseline|Active Snus|Tobacco-based, smokefree product
315708|NCT00843622|P2|Participant Flow|Placebo Snus|Non-tobacco, non-nicotine placebo product
315709|NCT00843622|P1|Participant Flow|Active Snus|Tobacco-based, smokefree product
315710|NCT00843622|O2|Outcome|Placebo Snus|Non-tobacco, non-nicotine placebo product
315711|NCT00843622|O1|Outcome|Active Snus|Tobacco-based, smokefree product
315712|NCT00843622|E2|Reported Event|Placebo Snus|Non-tobacco, non-nicotine placebo product
315713|NCT00843622|E1|Reported Event|Active Snus|Tobacco-based, smokefree product
315714|NCT00843492|B3|Baseline|Total|Total of all reporting groups
315715|NCT00843492|B2|Baseline|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315716|NCT00843492|B1|Baseline|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315717|NCT00843492|P2|Participant Flow|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315718|NCT00843492|P1|Participant Flow|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315719|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315720|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315721|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315722|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315723|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315724|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315725|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315726|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315772|NCT00843349|E3|Reported Event|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
315727|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315728|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315729|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315730|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315731|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315732|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315733|NCT00843492|E2|Reported Event|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
315734|NCT00843492|E1|Reported Event|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
315735|NCT00843479|B3|Baseline|Total|Total of all reporting groups
315736|NCT00843479|B2|Baseline|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315737|NCT00843479|B1|Baseline|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315738|NCT00843479|P2|Participant Flow|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315739|NCT00843479|P1|Participant Flow|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315740|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315741|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315742|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315743|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315744|NCT00843479|O2|Outcome|Middle-age NGT|Middle-age normoglycemic subjects 35 to 50 years old
315745|NCT00843479|O1|Outcome|Elderly NGT|Normoglycemic subjects 65-80 years old
315746|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315747|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315748|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315749|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315750|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315751|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315752|NCT00843479|E2|Reported Event|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
315753|NCT00843479|E1|Reported Event|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
315754|NCT00843349|B5|Baseline|Total|Total of all reporting groups
315755|NCT00843349|B4|Baseline|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
315756|NCT00843349|B3|Baseline|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
315757|NCT00843349|B2|Baseline|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
315758|NCT00843349|B1|Baseline|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
315759|NCT00843349|P4|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate Placebo|no dietary intervention + Lanthanum Carbonate placebo
315760|NCT00843349|P3|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
315761|NCT00843349|P2|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
315762|NCT00843349|P1|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate (LC)|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
315763|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
315764|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
315765|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
315766|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
315767|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
315768|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
315769|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
315770|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
315771|NCT00843349|E4|Reported Event|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
316336|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
315773|NCT00843349|E2|Reported Event|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
315774|NCT00843349|E1|Reported Event|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
315775|NCT00843310|B1|Baseline|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315776|NCT00843310|P1|Participant Flow|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315777|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315778|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315779|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315780|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315781|NCT00843310|E1|Reported Event|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
315782|NCT00843284|B1|Baseline|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315783|NCT00843284|P1|Participant Flow|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315784|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315785|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315786|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315787|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315788|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315789|NCT00843284|E1|Reported Event|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
315790|NCT00843180|B3|Baseline|Total|Total of all reporting groups
315791|NCT00843180|B2|Baseline|Control|usual care only as control arm hospital care during bone marrow transplant
315792|NCT00843180|B1|Baseline|Massage|massage and acupressure up to 3x/week for entire hospital stay
315793|NCT00843180|P2|Participant Flow|Control|usual care only as control arm hospital care during bone marrow transplant
315794|NCT00843180|P1|Participant Flow|Massage|massage and acupressure up to 3x/week for entire hospital stay
315795|NCT00843180|O2|Outcome|Control|
315796|NCT00843180|O1|Outcome|Massage|
315797|NCT00843180|O2|Outcome|Control|
315798|NCT00843180|O1|Outcome|Massage|
315799|NCT00843180|O2|Outcome|Control|
315800|NCT00843180|O1|Outcome|Massage|
315801|NCT00843180|O2|Outcome|Control|
315802|NCT00843180|O1|Outcome|Massage|
315803|NCT00843180|E2|Reported Event|Control|usual care only as control arm hospital care during bone marrow transplant
315804|NCT00843180|E1|Reported Event|Massage|massage and acupressure up to 3x/week for entire hospital stay
315805|NCT00843167|B3|Baseline|Total|Total of all reporting groups
315806|NCT00843167|B2|Baseline|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315807|NCT00843167|B1|Baseline|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
316190|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
315808|NCT00843167|P2|Participant Flow|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315809|NCT00843167|P1|Participant Flow|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
315810|NCT00843167|O2|Outcome|Treatment|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315811|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
315812|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315813|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
315814|NCT00843167|O3|Outcome|Invasive Ductal Carcinoma Tissue; Ki-67|Sulforaphane Supplement= 7, Placebo= 6
315815|NCT00843167|O2|Outcome|DCIS Tissue; Ki-67|Sulforaphane Supplement= 6, Placebo = 13
315816|NCT00843167|O1|Outcome|Benign Tissue; Ki-67|Sulforaphane Supplement = 23, Placebo = 25
315817|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315818|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
315819|NCT00843167|E2|Reported Event|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
315820|NCT00843167|E1|Reported Event|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
315821|NCT00843115|B1|Baseline|Donepezil|As per physician prescription
315822|NCT00843115|P1|Participant Flow|Donepezil|As per physician prescription
315823|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315824|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315825|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315826|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315827|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315828|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315829|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315830|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315831|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315832|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315833|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315834|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315835|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315836|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315837|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315838|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315839|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315840|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315841|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315842|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315843|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315844|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315845|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315846|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315847|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315848|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315849|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315850|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315851|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315852|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315853|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315854|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315855|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315856|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315857|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315858|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315859|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315860|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315861|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315862|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315863|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315864|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315865|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
315866|NCT00843115|E1|Reported Event|Donepezil|As per physician prescription
315867|NCT00843050|B1|Baseline|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
315868|NCT00843050|P1|Participant Flow|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
315869|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
315870|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
315871|NCT00843050|O1|Outcome|P276-00|P276-00: All patients received P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there was progression of disease or unacceptable toxicity
315872|NCT00843050|E1|Reported Event|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
315873|NCT00843024|B5|Baseline|Total|Total of all reporting groups
315874|NCT00843024|B4|Baseline|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315875|NCT00843024|B3|Baseline|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315876|NCT00843024|B2|Baseline|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315877|NCT00843024|B1|Baseline|Placebo|A single matching placebo tablet taken within a 12-week period
315878|NCT00843024|P6|Participant Flow|Sumatriptan 85 mg/ Naproxen 500 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315879|NCT00843024|P5|Participant Flow|Sumatriptan 30 mg/ Naproxen 180 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315880|NCT00843024|P4|Participant Flow|Sumatriptan 10 mg/ Naproxen 60 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315881|NCT00843024|P3|Participant Flow|Placebo|After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
315882|NCT00843024|P2|Participant Flow|15 to 17 Years Age Group: Single-blind Phase|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
315883|NCT00843024|P1|Participant Flow|12 to 14 Years Age Group: Single-blind Phase|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
315884|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315885|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315886|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315887|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315888|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315889|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315890|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315891|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315892|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315893|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315894|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315895|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315896|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315897|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
315898|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315899|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315900|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315901|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315902|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315903|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315904|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315905|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315906|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315907|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315908|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315909|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315910|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315911|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315912|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315913|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315914|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315915|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315916|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315917|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315918|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315919|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315920|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315921|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315922|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315923|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315924|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315925|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315926|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315927|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315928|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315929|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315930|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315931|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315932|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315933|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315934|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315935|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315936|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315937|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315938|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315939|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315940|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315941|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
315942|NCT00843024|E5|Reported Event|Single-blind Run-In Phase Placebo|One tablet of single-blind placebo taken during the Run-In Phase
315943|NCT00843024|E4|Reported Event|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
315944|NCT00843024|E3|Reported Event|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
315945|NCT00843024|E2|Reported Event|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
315946|NCT00843024|E1|Reported Event|Placebo|A single matching double-blind placebo tablet taken within a 12-week period
315947|NCT00842985|B1|Baseline|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
315948|NCT00842985|P1|Participant Flow|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
315949|NCT00842985|O4|Outcome|Placebo+Placebo|Session where placebo THC and Placebo Modafinil were given.
315950|NCT00842985|O3|Outcome|Pla+Modafinil|Session where Placebo THC and Modafinil were given
315951|NCT00842985|O2|Outcome|THC+Placebo|Session where TCH and Placebo Modafinil were given
315952|NCT00842985|O1|Outcome|THC+Modafinil|Session where THC+Modafinil was given.
315953|NCT00842985|E1|Reported Event|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
315954|NCT00842946|B3|Baseline|Total|Total of all reporting groups
315955|NCT00842946|B2|Baseline|Habituation|Behavioral exposure within the context of habituation.
315956|NCT00842946|B1|Baseline|Acceptance|Behavioral exposure within the context of psychological acceptance.
315957|NCT00842946|P2|Participant Flow|Habituation|Behavioral exposure within the context of habituation.
315958|NCT00842946|P1|Participant Flow|Acceptance|Behavioral exposure within the context of psychological acceptance.
315959|NCT00842946|O2|Outcome|Habituation|Behavioral exposure within the context of habituation.
315960|NCT00842946|O1|Outcome|Acceptance|Behavioral exposure within the context of psychological acceptance.
315961|NCT00842946|E2|Reported Event|Habituation|Behavioral exposure within the context of habituation.
315962|NCT00842946|E1|Reported Event|Acceptance|Behavioral exposure within the context of psychological acceptance.
315963|NCT00842829|B3|Baseline|Total|Total of all reporting groups
315964|NCT00842829|B2|Baseline|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315965|NCT00842829|B1|Baseline|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315966|NCT00842829|P3|Participant Flow|FBT - Treatment and Continuation Periods|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
315967|NCT00842829|P2|Participant Flow|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315968|NCT00842829|P1|Participant Flow|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315969|NCT00842829|O4|Outcome|FBT - Continuation Period|The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
315970|NCT00842829|O3|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315971|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315972|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315973|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315974|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315975|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315976|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315977|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315978|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315979|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315980|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315981|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315982|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315983|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315984|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315985|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315986|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315987|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315988|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315989|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315990|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315991|NCT00842829|O2|Outcome|60 Minutes|Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.
315992|NCT00842829|O1|Outcome|30 Minutes|Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.
315993|NCT00842829|O2|Outcome|During Treatment Period|The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.
315994|NCT00842829|O1|Outcome|During Titration Period|The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.
315995|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315996|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315997|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
315998|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
315999|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
316000|NCT00842829|E1|Reported Event|FBT - All Doses and Study Periods|Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
316001|NCT00842751|B1|Baseline|All Study Participants|
316002|NCT00842751|P1|Participant Flow|Acyline + Testosterone Undecanoate + Placebo Finasteride|Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
316003|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
316004|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
316005|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, twice daily (BID) orally + placebo finasteride
316006|NCT00842751|O3|Outcome|Acyline + Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
316007|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
316008|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg subcutaneous (SC) +Testosterone Undecanoate 200 mg, BID orally + Placebo finasteride
316009|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
316010|NCT00842751|O2|Outcome|Acyline +Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally
316011|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride
316191|NCT00842075|E2|Reported Event|2 Usual Regimen|Usual bolus insulin dose at each meal
316012|NCT00842751|E3|Reported Event|Third Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
316013|NCT00842751|E2|Reported Event|Second Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally
316014|NCT00842751|E1|Reported Event|First Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally
316015|NCT00842712|B8|Baseline|Total|Total of all reporting groups
316016|NCT00842712|B7|Baseline|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316017|NCT00842712|B6|Baseline|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316018|NCT00842712|B5|Baseline|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316019|NCT00842712|B4|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316020|NCT00842712|B3|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316021|NCT00842712|B2|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316022|NCT00842712|B1|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316023|NCT00842712|P7|Participant Flow|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316024|NCT00842712|P6|Participant Flow|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316025|NCT00842712|P5|Participant Flow|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316026|NCT00842712|P4|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316027|NCT00842712|P3|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316258|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316028|NCT00842712|P2|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316029|NCT00842712|P1|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316030|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316031|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316032|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316033|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316034|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316035|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316036|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316037|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316081|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316082|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316038|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316039|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316040|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316041|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316042|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316043|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316044|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316045|NCT00842712|O4|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316046|NCT00842712|O3|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316047|NCT00842712|O2|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316048|NCT00842712|O1|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316049|NCT00842712|E7|Reported Event|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
319037|NCT00834405|P2|Participant Flow|Arava®|Arava® 20 mg Tablet
316050|NCT00842712|E6|Reported Event|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316051|NCT00842712|E5|Reported Event|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
316052|NCT00842712|E4|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316053|NCT00842712|E3|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316054|NCT00842712|E2|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316055|NCT00842712|E1|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
316056|NCT00842543|B5|Baseline|Total|Total of all reporting groups
316057|NCT00842543|B4|Baseline|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
316058|NCT00842543|B3|Baseline|Overweight Placebo|Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
316059|NCT00842543|B2|Baseline|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316060|NCT00842543|B1|Baseline|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316061|NCT00842543|P4|Participant Flow|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
316062|NCT00842543|P3|Participant Flow|Overweight Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
316063|NCT00842543|P2|Participant Flow|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316064|NCT00842543|P1|Participant Flow|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316065|NCT00842543|O4|Outcome|Lean Placebo|
316066|NCT00842543|O3|Outcome|Overweight Placebo|Reesults displayed for overweight boys who received 6 months of Placebo intervention
316067|NCT00842543|O2|Outcome|Lean FVJC|
316068|NCT00842543|O1|Outcome|Overweight FVJC|Results displayed for overweight boys who received 6 months of FVJC intervention
316069|NCT00842543|O2|Outcome|Lean|Lean boys prior to receiving intervention.
316070|NCT00842543|O1|Outcome|Overweight|Overweight boys prior to receiving intervention.
316071|NCT00842543|E4|Reported Event|Lean Placebo|Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
316072|NCT00842543|E3|Reported Event|Overweight Placebo|Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
316073|NCT00842543|E2|Reported Event|Lean FVJC|Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316074|NCT00842543|E1|Reported Event|Overweight FVJC|Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
316075|NCT00842361|B3|Baseline|Total|Total of all reporting groups
316076|NCT00842361|B2|Baseline|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316077|NCT00842361|B1|Baseline|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316078|NCT00842361|P2|Participant Flow|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316079|NCT00842361|P1|Participant Flow|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316080|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316188|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
316083|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316084|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316085|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316086|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316087|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316088|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316089|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316090|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316091|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316092|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316093|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316094|NCT00842361|E2|Reported Event|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
316095|NCT00842361|E1|Reported Event|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
316096|NCT00842348|B3|Baseline|Total|Total of all reporting groups
316097|NCT00842348|B2|Baseline|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
316098|NCT00842348|B1|Baseline|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
316099|NCT00842348|P2|Participant Flow|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
316100|NCT00842348|P1|Participant Flow|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
316101|NCT00842348|O2|Outcome|Placebo - Randomised Treatment in Study 726|All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
316102|NCT00842348|O1|Outcome|Lanreotide Autogel - Randomised Treatment in Study 726|All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
316103|NCT00842348|O3|Outcome|Total|All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
316104|NCT00842348|O2|Outcome|Placebo|Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
316105|NCT00842348|O1|Outcome|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
316106|NCT00842348|E3|Reported Event|Total|All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
316107|NCT00842348|E2|Reported Event|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
316108|NCT00842348|E1|Reported Event|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
316109|NCT00842335|B1|Baseline|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
316110|NCT00842335|P1|Participant Flow|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
316111|NCT00842335|O1|Outcome|All Subjects|
316112|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
316113|NCT00842335|O1|Outcome|All Subjects|"The starting dose of JI-101 for patients in the first cohort was 100 mg QD. All patients took JI-101 without food on Day 0, with a high fat meal on Day 2, and with a regular diet on Day 3 onwards. Patients in the first three cohorts were dosed QD. Based on PK characteristics observed from the first eight patients (Cohort 1, Cohort 2, and Cohort 3), subsequent cohorts were dosed BID.~After the first eight patients, the combined PK profiles of the enrolled patients were studied. These assessments indicated that the PK profile for JI-101 supported BID dosing. Therefore, BID dosing was administered to patients who enrolled in the study following the effective date of Protocol"
316114|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
316115|NCT00842335|E1|Reported Event|JI-101|Maximum tolerated dose
316116|NCT00842244|B1|Baseline|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316117|NCT00842244|P1|Participant Flow|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316118|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316119|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316120|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316121|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316122|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316123|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316124|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316125|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316126|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316127|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316128|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316129|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316130|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316131|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316132|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316133|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316134|NCT00842244|E1|Reported Event|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
316135|NCT00842231|B1|Baseline|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316136|NCT00842231|P1|Participant Flow|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316137|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316138|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316139|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316140|NCT00842231|E1|Reported Event|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
316141|NCT00842153|B3|Baseline|Total|Total of all reporting groups
316142|NCT00842153|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316143|NCT00842153|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316144|NCT00842153|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316145|NCT00842153|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316146|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316147|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316148|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316189|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
316149|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316150|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316151|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316152|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316153|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316154|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316155|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316156|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316157|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316158|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316159|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316160|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316161|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316162|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316163|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316164|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316165|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316166|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316167|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316168|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316169|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316170|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316171|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316172|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316173|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316174|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316175|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316176|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316177|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316178|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316179|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316180|NCT00842153|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
316181|NCT00842153|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
316182|NCT00842075|B3|Baseline|Total|Total of all reporting groups
316183|NCT00842075|B2|Baseline|2 Usual Regimen|Usual bolus insulin dose at each meal
316184|NCT00842075|B1|Baseline|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
316185|NCT00842075|P2|Participant Flow|2 Usual Regimen|Usual bolus insulin dose at each meal
316186|NCT00842075|P1|Participant Flow|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
316187|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
319041|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
316192|NCT00842075|E1|Reported Event|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
316193|NCT00842023|B3|Baseline|Total|Total of all reporting groups
316194|NCT00842023|B2|Baseline|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
316195|NCT00842023|B1|Baseline|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316196|NCT00842023|P2|Participant Flow|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
316197|NCT00842023|P1|Participant Flow|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316198|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
316199|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316200|NCT00842023|O2|Outcome|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
316201|NCT00842023|O1|Outcome|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316202|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
316203|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316204|NCT00842023|E2|Reported Event|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
316205|NCT00842023|E1|Reported Event|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
316206|NCT00841971|B3|Baseline|Total|Total of all reporting groups
316207|NCT00841971|B2|Baseline|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
316208|NCT00841971|B1|Baseline|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
316209|NCT00841971|P2|Participant Flow|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
316210|NCT00841971|P1|Participant Flow|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
316211|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
316212|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
316213|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
316214|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
316215|NCT00841971|E2|Reported Event|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
316216|NCT00841971|E1|Reported Event|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
316217|NCT00841906|B3|Baseline|Total|Total of all reporting groups
316218|NCT00841906|B2|Baseline|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316219|NCT00841906|B1|Baseline|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316220|NCT00841906|P2|Participant Flow|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316221|NCT00841906|P1|Participant Flow|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316259|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316260|NCT00841776|E2|Reported Event|Ziana|Clindamycin and topical tretinoin gel
316222|NCT00841906|O2|Outcome|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316223|NCT00841906|O1|Outcome|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316224|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316225|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316226|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316227|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316228|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316229|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
316230|NCT00841906|E2|Reported Event|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316231|NCT00841906|E1|Reported Event|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
316232|NCT00841815|B3|Baseline|Total|Total of all reporting groups
316233|NCT00841815|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
316234|NCT00841815|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
316235|NCT00841815|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
316236|NCT00841815|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
316237|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316238|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316239|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316240|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316241|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316242|NCT00841815|O1|Outcome|Amlodipine Besylate|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316243|NCT00841776|B3|Baseline|Total|Total of all reporting groups
316244|NCT00841776|B2|Baseline|Ziana|Clindamycin and topical tretinoin gel
316245|NCT00841776|B1|Baseline|Duac|Clindamycin and benzoyl peroxide topical gel
316246|NCT00841776|P2|Participant Flow|Ziana|Clindamycin and topical tretinoin gel
316247|NCT00841776|P1|Participant Flow|Duac|Clindamycin and benzoyl peroxide topical gel
316248|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316249|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316250|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316251|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316252|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316253|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316254|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316255|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316256|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
316257|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
316263|NCT00841763|B2|Baseline|PL+ aTIV|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
316264|NCT00841763|B1|Baseline|TIV + aH5N1|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1).
316265|NCT00841763|P4|Participant Flow|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
316266|NCT00841763|P3|Participant Flow|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316267|NCT00841763|P2|Participant Flow|PL+ aTIV (18 to 60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
316268|NCT00841763|P1|Participant Flow|TIV + aH5N1 (18 to 60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316269|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316270|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316271|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316272|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316273|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316274|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316275|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316276|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316277|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316278|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316279|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316280|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316281|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316282|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316283|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316284|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316285|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316286|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316287|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316288|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316289|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316290|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316291|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316292|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316293|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316294|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316295|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316296|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316297|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316298|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316299|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas ≥25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316300|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316301|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers ≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316302|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316303|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316304|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1).
316305|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316306|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316307|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316308|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316309|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316310|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316311|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316312|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316313|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316314|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316315|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316316|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316317|NCT00841763|O4|Outcome|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
316318|NCT00841763|O3|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316319|NCT00841763|O2|Outcome|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
316320|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316321|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316322|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
316323|NCT00841763|E4|Reported Event|PL+MF59-eTIV (>60yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
316324|NCT00841763|E3|Reported Event|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (MF59-eH5N1)
316325|NCT00841763|E2|Reported Event|PL+MF59-eTIV (18-60yrs)|First dose of placebo(PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
316326|NCT00841763|E1|Reported Event|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
316327|NCT00841698|B3|Baseline|Total|Total of all reporting groups
316328|NCT00841698|B2|Baseline|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
316329|NCT00841698|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
316330|NCT00841698|P2|Participant Flow|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
316331|NCT00841698|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
316332|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
316333|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
316334|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
316337|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
316338|NCT00841672|B3|Baseline|Total|Total of all reporting groups
316339|NCT00841672|B2|Baseline|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316340|NCT00841672|B1|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316341|NCT00841672|P2|Participant Flow|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316342|NCT00841672|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316343|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316344|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316345|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316346|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316347|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316348|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316349|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316350|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316351|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316352|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316353|NCT00841672|E2|Reported Event|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
316354|NCT00841672|E1|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
316355|NCT00841659|B3|Baseline|Total|Total of all reporting groups
316356|NCT00841659|B2|Baseline|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
316357|NCT00841659|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
316358|NCT00841659|P2|Participant Flow|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
316359|NCT00841659|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
316360|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
316361|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
316362|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
316363|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
316364|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
316365|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
316366|NCT00841555|B1|Baseline|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316396|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316397|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
316367|NCT00841555|P1|Participant Flow|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316368|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316369|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316370|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316371|NCT00841555|E1|Reported Event|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
316372|NCT00841542|B3|Baseline|Total|Total of all reporting groups
316373|NCT00841542|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
316374|NCT00841542|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
316375|NCT00841542|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
316376|NCT00841542|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
316377|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316378|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316379|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316380|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316381|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
316382|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
316383|NCT00841412|B1|Baseline|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
316384|NCT00841412|P2|Participant Flow|Delayed Intervention Group/Units|Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
316385|NCT00841412|P1|Participant Flow|Immediate Intervention Group/Units|Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.
316386|NCT00841412|O1|Outcome|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
316387|NCT00841412|E1|Reported Event|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
316388|NCT00841321|B3|Baseline|Total|Total of all reporting groups
316389|NCT00841321|B2|Baseline|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316390|NCT00841321|B1|Baseline|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
316391|NCT00841321|P2|Participant Flow|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316392|NCT00841321|P1|Participant Flow|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
316393|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
316394|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
316395|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316398|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
316399|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316400|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316401|NCT00841321|E2|Reported Event|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
316402|NCT00841321|E1|Reported Event|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
316403|NCT00841269|B1|Baseline|Open Label Uridine Treatment|All participants were Caucasian. There were 5 female participants and 2 male participants.
316404|NCT00841269|P1|Participant Flow|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
316405|NCT00841269|O1|Outcome|Open Label Uridine Treatment|
316406|NCT00841269|E1|Reported Event|Uridine 500 mg by Mouth Twice Daily for 6 Weeks|Because this was an open-label study, all participants received the investigational drug uridine.
316407|NCT00841204|B3|Baseline|Total|Total of all reporting groups
316408|NCT00841204|B2|Baseline|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316409|NCT00841204|B1|Baseline|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316410|NCT00841204|P2|Participant Flow|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316411|NCT00841204|P1|Participant Flow|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316412|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316413|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316414|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316415|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316416|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316417|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316418|NCT00841204|E2|Reported Event|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
316419|NCT00841204|E1|Reported Event|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
316420|NCT00841087|B3|Baseline|Total|Total of all reporting groups
316421|NCT00841087|B2|Baseline|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316422|NCT00841087|B1|Baseline|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316423|NCT00841087|P2|Participant Flow|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316424|NCT00841087|P1|Participant Flow|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316425|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316426|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316427|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316428|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316429|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316430|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316431|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316432|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316433|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316434|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316566|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
316435|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316436|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316437|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316438|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316439|NCT00841087|E2|Reported Event|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316440|NCT00841087|E1|Reported Event|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
316441|NCT00841035|B1|Baseline|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
316442|NCT00841035|P1|Participant Flow|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
316443|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
316444|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
316445|NCT00841035|E1|Reported Event|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
316446|NCT00840996|B3|Baseline|Total|Total of all reporting groups
316447|NCT00840996|B2|Baseline|Placebo|Perioperative equal volume of saline placebo IV infusion
316448|NCT00840996|B1|Baseline|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316449|NCT00840996|P2|Participant Flow|Placebo|Perioperative equal volume of saline placebo IV infusion
316450|NCT00840996|P1|Participant Flow|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316451|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316452|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316453|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316454|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316455|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316456|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316457|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316458|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316459|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316460|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316461|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316462|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316463|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
316464|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316465|NCT00840996|E2|Reported Event|Placebo|Perioperative equal volume of saline placebo IV infusion
316466|NCT00840996|E1|Reported Event|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
316467|NCT00840879|B3|Baseline|Total|Total of all reporting groups
316468|NCT00840879|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
316469|NCT00840879|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
316470|NCT00840879|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
316471|NCT00840879|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
316472|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316473|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316474|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316475|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316476|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316477|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316478|NCT00840866|B3|Baseline|Total|Total of all reporting groups
316479|NCT00840866|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
316480|NCT00840866|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
316481|NCT00840866|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
316482|NCT00840866|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
316483|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316484|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316485|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316486|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316487|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316488|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316489|NCT00840840|B3|Baseline|Total|Total of all reporting groups
316490|NCT00840840|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
316491|NCT00840840|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
316492|NCT00840840|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
316493|NCT00840840|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
316494|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316495|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316496|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316497|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316498|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316499|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316500|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316501|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316502|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316503|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316504|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316505|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316506|NCT00840658|B5|Baseline|Total|Total of all reporting groups
316507|NCT00840658|B4|Baseline|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
316508|NCT00840658|B3|Baseline|C:Interactive Sexual Risk & Didactic Safer Injection Education|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI)and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture-format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
316509|NCT00840658|B2|Baseline|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
316510|NCT00840658|B1|Baseline|A: Didactic Safer Injection & Sexual Activity Education|In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
316511|NCT00840658|P4|Participant Flow|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
316512|NCT00840658|P3|Participant Flow|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
316513|NCT00840658|P2|Participant Flow|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
316514|NCT00840658|P1|Participant Flow|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
316515|NCT00840658|O4|Outcome|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
316516|NCT00840658|O3|Outcome|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
316517|NCT00840658|O2|Outcome|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
316518|NCT00840658|O1|Outcome|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
316519|NCT00840658|E4|Reported Event|D: Interactive Injection and Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
316567|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
316568|NCT00840294|B3|Baseline|Total|Total of all reporting groups
316569|NCT00840294|B2|Baseline|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
316570|NCT00840294|B1|Baseline|Observation|Observation only for 2 weeks
319042|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
316520|NCT00840658|E3|Reported Event|C:Interactive Sexual Risk Intervention & Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
316521|NCT00840658|E2|Reported Event|B: Interactive Injection Risk Intervention and Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
316522|NCT00840658|E1|Reported Event|A: Didactic Safer Injection and Sexual Activity Education|In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
316523|NCT00840632|B3|Baseline|Total|Total of all reporting groups
316524|NCT00840632|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
316525|NCT00840632|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
316526|NCT00840632|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
316527|NCT00840632|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
316528|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316529|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316530|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316531|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316532|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316533|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316534|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316535|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316536|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316537|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316538|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316539|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316540|NCT00840476|B3|Baseline|Total|Total of all reporting groups
316541|NCT00840476|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
316542|NCT00840476|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
316543|NCT00840476|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
316544|NCT00840476|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
316545|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316546|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316547|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316548|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316549|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
316550|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
316551|NCT00840450|B1|Baseline|Paclitaxel and Imatinib Mesylate (Gleevec)|
316552|NCT00840450|P1|Participant Flow|Paclitaxel and Imatinib Mesylate (Gleevec)|
316553|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
316554|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
316555|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
316556|NCT00840450|E1|Reported Event|Paclitaxel and Imatinib Mesylate (Gleevec)|
316557|NCT00840411|B3|Baseline|Total|Total of all reporting groups
316558|NCT00840411|B2|Baseline|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
316559|NCT00840411|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
316560|NCT00840411|P2|Participant Flow|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
316561|NCT00840411|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
316562|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
316563|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
316564|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
316565|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
316571|NCT00840294|P2|Participant Flow|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
316572|NCT00840294|P1|Participant Flow|Observation|Observation only for 2 weeks
316573|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
316574|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
316575|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
316576|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
316577|NCT00840294|E2|Reported Event|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
316578|NCT00840294|E1|Reported Event|Observation|Observation only for 2 weeks
316579|NCT00840281|B3|Baseline|Total|Total of all reporting groups
316580|NCT00840281|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
316581|NCT00840281|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
316582|NCT00840281|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
316583|NCT00840281|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
316584|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316585|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316586|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316587|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316588|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
316589|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
316590|NCT00840216|B3|Baseline|Total|Total of all reporting groups
316591|NCT00840216|B2|Baseline|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
316592|NCT00840216|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
316593|NCT00840216|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
316594|NCT00840216|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
316595|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
316596|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
316597|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
316598|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
316599|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
316600|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
316601|NCT00840203|B3|Baseline|Total|Total of all reporting groups
316602|NCT00840203|B2|Baseline|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
316603|NCT00840203|B1|Baseline|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
316604|NCT00840203|P2|Participant Flow|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
316605|NCT00840203|P1|Participant Flow|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
316606|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316607|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316608|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316609|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316610|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316611|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316612|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316613|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316614|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316615|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316616|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
316617|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
316618|NCT00840099|B3|Baseline|Total|Total of all reporting groups
316619|NCT00840099|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
316620|NCT00840099|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
316717|NCT00839917|E1|Reported Event|ProQuad™|Single subcutaneous 0.5 mL vaccination
316718|NCT00839800|B3|Baseline|Total|Total of all reporting groups
316621|NCT00840099|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
316622|NCT00840099|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
316623|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316624|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316625|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316626|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316627|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316628|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316629|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316630|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316631|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316632|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316633|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
316634|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
316635|NCT00840086|B1|Baseline|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
316636|NCT00840086|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
316637|NCT00840086|O3|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
316638|NCT00840086|O2|Outcome|Part C|Surgery sub-trial: This part of the trial included any of the patients from Part A and Part B that during the course of the trial needed to undergo a major or minor surgical procedure requiring at least 7 days of daily FVIII treatment, including the day of surgery. Patients received a preoperative loading dose of turoctocog alfa immediately prior to the surgical procedure. On the day of surgery and until Day 7 (included) turoctocog alfa was dose adjusted aiming for a trough level above 0.50 IU/mL. Day 8 to last day of the surgical recovery period (if relevant) turoctocog alfa was dosed according to local guidelines.
316639|NCT00840086|O1|Outcome|Total (Part A + Part B)|Preventive treatment and treatment of bleeds: The doses were individualised based on the trough FVIII activity level. The doses could be adjusted by the investigator. The dose level chosen was 20-40 IU/kg every second day or 20-50 IU/kg three times per week (Part A + Part B). Subjects previously treated with turoctocog alpha were included in Part A.
316640|NCT00840086|O1|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
316641|NCT00840086|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
316642|NCT00840073|B3|Baseline|Total|Total of all reporting groups
316643|NCT00840073|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
316644|NCT00840073|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
316645|NCT00840073|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
316646|NCT00840073|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
316647|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316648|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316649|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316650|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316651|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316652|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316653|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316654|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316655|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
316656|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
316657|NCT00840060|B3|Baseline|Total|Total of all reporting groups
316658|NCT00840060|B2|Baseline|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
316659|NCT00840060|B1|Baseline|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
316660|NCT00840060|P2|Participant Flow|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
316719|NCT00839800|B2|Baseline|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316661|NCT00840060|P1|Participant Flow|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
316662|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
316663|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
316664|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
316665|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
316666|NCT00840060|E2|Reported Event|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
316667|NCT00840060|E1|Reported Event|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
316668|NCT00839930|B3|Baseline|Total|Total of all reporting groups
316669|NCT00839930|B2|Baseline|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
316670|NCT00839930|B1|Baseline|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
316671|NCT00839930|P2|Participant Flow|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
316672|NCT00839930|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
316673|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
316674|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
316675|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
316676|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
316677|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
316678|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
316679|NCT00839917|B3|Baseline|Total|Total of all reporting groups
316680|NCT00839917|B2|Baseline|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316681|NCT00839917|B1|Baseline|ProQuad™|Single subcutaneous 0.5 mL vaccination
316682|NCT00839917|P2|Participant Flow|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316683|NCT00839917|P1|Participant Flow|ProQuad™|Single subcutaneous 0.5 mL vaccination
316684|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316685|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316686|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316687|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316688|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316689|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316690|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316691|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316692|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316693|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316694|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316695|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316696|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316697|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316698|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316699|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316700|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316701|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316702|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316703|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316704|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316705|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316706|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316707|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316708|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316709|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316710|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316711|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316712|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316713|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316714|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316715|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
316716|NCT00839917|E2|Reported Event|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
316720|NCT00839800|B1|Baseline|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316721|NCT00839800|P2|Participant Flow|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316722|NCT00839800|P1|Participant Flow|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316723|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316724|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316725|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316726|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316727|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316728|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316729|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316730|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316731|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316732|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316733|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316734|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316735|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316736|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316737|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316738|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316739|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316740|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316741|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316742|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316743|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316744|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316745|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316746|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316747|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316748|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316749|NCT00839800|E2|Reported Event|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
316750|NCT00839800|E1|Reported Event|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
316751|NCT00839540|B4|Baseline|Total|Total of all reporting groups
316752|NCT00839540|B3|Baseline|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
316753|NCT00839540|B2|Baseline|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
316754|NCT00839540|B1|Baseline|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
316755|NCT00839540|P3|Participant Flow|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
316756|NCT00839540|P2|Participant Flow|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
316757|NCT00839540|P1|Participant Flow|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
316758|NCT00839540|O3|Outcome|Log Inhibition of 200 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect.
316759|NCT00839540|O2|Outcome|Log Inhibition of 100 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect.
316760|NCT00839540|O1|Outcome|Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
316761|NCT00839540|E3|Reported Event|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
316762|NCT00839540|E2|Reported Event|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
316763|NCT00839540|E1|Reported Event|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
316764|NCT00839527|B4|Baseline|Total|Total of all reporting groups
316765|NCT00839527|B3|Baseline|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316766|NCT00839527|B2|Baseline|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316767|NCT00839527|B1|Baseline|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316768|NCT00839527|P3|Participant Flow|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316769|NCT00839527|P2|Participant Flow|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316770|NCT00839527|P1|Participant Flow|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316771|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316772|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316773|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316774|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316775|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316776|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316777|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316778|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316779|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316780|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316865|NCT00839319|P5|Participant Flow|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316781|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316782|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316783|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316784|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316785|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316786|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316787|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316788|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316789|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316790|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316791|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316792|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316793|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316794|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316795|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316796|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316797|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316866|NCT00839319|P4|Participant Flow|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316798|NCT00839527|E3|Reported Event|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316799|NCT00839527|E2|Reported Event|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316800|NCT00839527|E1|Reported Event|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
316801|NCT00839436|B4|Baseline|Total|Total of all reporting groups
316802|NCT00839436|B3|Baseline|20 mcg/kg Cohort|
316803|NCT00839436|B2|Baseline|10 mcg/kg Cohort|
316804|NCT00839436|B1|Baseline|3 mcg/kg Cohort|
316805|NCT00839436|P3|Participant Flow|20 mcg/kg Cohort|
316806|NCT00839436|P2|Participant Flow|10 mcg/kg Cohort|
316807|NCT00839436|P1|Participant Flow|3 mcg/kg Cohort|
316808|NCT00839436|O3|Outcome|20 mcg/kg Cohort|
316809|NCT00839436|O2|Outcome|10 mcg/kg Cohort|
316810|NCT00839436|O1|Outcome|3 mcg/kg Cohort|
316811|NCT00839436|E3|Reported Event|20 mcg/kg Cohort|
316812|NCT00839436|E2|Reported Event|10 mcg/kg Cohort|
316813|NCT00839436|E1|Reported Event|3 mcg/kg Cohort|
316814|NCT00839423|B5|Baseline|Total|Total of all reporting groups
316815|NCT00839423|B4|Baseline|Venlafaxine 225 mg|capsules, daily, orally
316816|NCT00839423|B3|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316817|NCT00839423|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316818|NCT00839423|B1|Baseline|Placebo|capsules, daily, orally
316819|NCT00839423|P4|Participant Flow|Venlafaxine 225 mg|capsules, daily, orally
316820|NCT00839423|P3|Participant Flow|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316821|NCT00839423|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316822|NCT00839423|P1|Participant Flow|Placebo|capsules, daily, orally
316823|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316824|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316825|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316826|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316827|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316828|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316829|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316830|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316831|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316832|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316833|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316834|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316835|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316836|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316837|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316838|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316839|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316840|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316841|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316842|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316843|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316844|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316845|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316846|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316847|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316848|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316849|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316850|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316851|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
316852|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
316853|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
316854|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
316855|NCT00839423|E4|Reported Event|Venlafaxine 225 mg|
316856|NCT00839423|E3|Reported Event|Vortioxetine 10 mg|
316857|NCT00839423|E2|Reported Event|Vortioxetine 5 mg|
316858|NCT00839423|E1|Reported Event|Placebo|
316859|NCT00839319|B6|Baseline|Total|Total of all reporting groups
316860|NCT00839319|B5|Baseline|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316861|NCT00839319|B4|Baseline|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316862|NCT00839319|B3|Baseline|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316863|NCT00839319|B2|Baseline|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316864|NCT00839319|B1|Baseline|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316910|NCT00839241|P1|Participant Flow|Autologous Blood Transfusion|
316867|NCT00839319|P3|Participant Flow|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316868|NCT00839319|P2|Participant Flow|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316869|NCT00839319|P1|Participant Flow|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316870|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316871|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316872|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316873|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316874|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316875|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316876|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316877|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316878|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316879|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316880|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316881|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316882|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316883|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316884|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316885|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316886|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316887|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316888|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316889|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316890|NCT00839319|E5|Reported Event|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
316891|NCT00839319|E4|Reported Event|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
316892|NCT00839319|E3|Reported Event|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
316893|NCT00839319|E2|Reported Event|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
316894|NCT00839319|E1|Reported Event|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
316895|NCT00839306|B3|Baseline|Total|Total of all reporting groups
316896|NCT00839306|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316897|NCT00839306|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316898|NCT00839306|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316899|NCT00839306|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316900|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316901|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316902|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316903|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316904|NCT00839306|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316905|NCT00839306|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
316906|NCT00839241|B3|Baseline|Total|Total of all reporting groups
316907|NCT00839241|B2|Baseline|Allogenic Blood Transfusion|
316908|NCT00839241|B1|Baseline|Autologous Blood Transfusion|
316909|NCT00839241|P2|Participant Flow|Allogenic Blood Transfusion|
316994|NCT00839098|B3|Baseline|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
316995|NCT00839098|B2|Baseline|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
316996|NCT00839098|B1|Baseline|Control Group|Control Group
316997|NCT00839098|P3|Participant Flow|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
316998|NCT00839098|P2|Participant Flow|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
316999|NCT00839098|P1|Participant Flow|Control Group|Control Group
317000|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317001|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317002|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317003|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317004|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317005|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317006|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317007|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317008|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317009|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317010|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317011|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317012|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317013|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317014|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317015|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317016|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317017|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317018|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
317019|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
317020|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
317021|NCT00839098|E3|Reported Event|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
317022|NCT00839098|E2|Reported Event|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
317023|NCT00839098|E1|Reported Event|Control Group|Control Group
317024|NCT00839072|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
317025|NCT00839072|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 * 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
317026|NCT00839072|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"1 * 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
317027|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317028|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317029|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317030|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317031|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317032|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317033|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317034|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317157|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
317158|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
317035|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317036|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317037|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317038|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317039|NCT00839072|E2|Reported Event|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317040|NCT00839072|E1|Reported Event|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
317041|NCT00838929|B4|Baseline|Total|Total of all reporting groups
317042|NCT00838929|B3|Baseline|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317043|NCT00838929|B2|Baseline|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317044|NCT00838929|B1|Baseline|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317045|NCT00838929|P3|Participant Flow|Vorinostat (400 mg) and Radiation|
317046|NCT00838929|P2|Participant Flow|Vorinostat (300 mg) and Radiation|
317047|NCT00838929|P1|Participant Flow|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317048|NCT00838929|O1|Outcome|Vorinostat and Radiation - All Participants|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317049|NCT00838929|E3|Reported Event|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317050|NCT00838929|E2|Reported Event|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317051|NCT00838929|E1|Reported Event|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
317052|NCT00838916|B3|Baseline|Total|Total of all reporting groups
317159|NCT00838578|B1|Baseline|KRN330 + Irinotecan|open label, single arm
317249|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317053|NCT00838916|B2|Baseline|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317054|NCT00838916|B1|Baseline|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317055|NCT00838916|P2|Participant Flow|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317056|NCT00838916|P1|Participant Flow|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317057|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317058|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317059|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317060|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317061|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317062|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317063|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317064|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317065|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317066|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317067|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317068|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317069|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317250|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317070|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317071|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317072|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317073|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317074|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317075|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317076|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317077|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317078|NCT00838916|E2|Reported Event|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317079|NCT00838916|E1|Reported Event|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317080|NCT00838903|B5|Baseline|Total|Total of all reporting groups
317081|NCT00838903|B4|Baseline|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317082|NCT00838903|B3|Baseline|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317083|NCT00838903|B2|Baseline|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317084|NCT00838903|B1|Baseline|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317085|NCT00838903|P4|Participant Flow|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317086|NCT00838903|P3|Participant Flow|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317087|NCT00838903|P2|Participant Flow|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317251|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317088|NCT00838903|P1|Participant Flow|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317089|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317090|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317091|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317092|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317093|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317094|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317095|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317096|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317097|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317098|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317099|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317100|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317101|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317102|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317103|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317104|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317105|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
319043|NCT00834366|B3|Baseline|Total|Total of all reporting groups
317106|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317107|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317108|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317109|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317110|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317111|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317112|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317113|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317114|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317115|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317116|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317117|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317118|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317119|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317120|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317121|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317122|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317123|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317339|NCT00837824|P1|Participant Flow|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
317124|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317125|NCT00838903|E4|Reported Event|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317126|NCT00838903|E3|Reported Event|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317127|NCT00838903|E2|Reported Event|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317128|NCT00838903|E1|Reported Event|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
317129|NCT00838682|B3|Baseline|Total|Total of all reporting groups
317130|NCT00838682|B2|Baseline|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317131|NCT00838682|B1|Baseline|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317132|NCT00838682|P2|Participant Flow|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317133|NCT00838682|P1|Participant Flow|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317134|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317135|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317136|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317137|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317138|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317139|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317140|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317141|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317142|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317143|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317144|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317145|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317146|NCT00838682|E2|Reported Event|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317147|NCT00838682|E1|Reported Event|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
317148|NCT00838630|B3|Baseline|Total|Total of all reporting groups
317149|NCT00838630|B2|Baseline|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
317150|NCT00838630|B1|Baseline|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
317151|NCT00838630|P2|Participant Flow|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
317152|NCT00838630|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
317153|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
317154|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
317155|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
317156|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
317160|NCT00838578|P1|Participant Flow|KRN330 + Irinotecan|"Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)~Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)~Phase 1 and 2Combined (N=65)"
317161|NCT00838578|O3|Outcome|PH 2 Treatment: KRN330 Wkly + IRI Biwkly|The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
317162|NCT00838578|O2|Outcome|Regimen B: KRN330 Weekly + Irinotecan Biweekly|treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
317163|NCT00838578|O1|Outcome|Regimen A: KRN330 Biweekly + Irinotecan Biweekly|"In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).~Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly"
317164|NCT00838578|E3|Reported Event|Phase 2: KRN330 Weekly + IRI Biweekly|The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
317165|NCT00838578|E2|Reported Event|Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly|In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
317166|NCT00838578|E1|Reported Event|Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly|"In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):~Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2"
317167|NCT00838526|B3|Baseline|Total|Total of all reporting groups
317168|NCT00838526|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317169|NCT00838526|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317170|NCT00838526|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317171|NCT00838526|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317172|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317173|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317174|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317175|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317176|NCT00838526|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317177|NCT00838526|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
317178|NCT00838513|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317179|NCT00838513|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317180|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317181|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317182|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317199|NCT00838279|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
317252|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317183|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317184|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317185|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317186|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317187|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317188|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317189|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317190|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317191|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317192|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317193|NCT00838513|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
317194|NCT00838331|B1|Baseline|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
317195|NCT00838331|P1|Participant Flow|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
317196|NCT00838331|O1|Outcome|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
317197|NCT00838331|E1|Reported Event|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
317198|NCT00838279|B3|Baseline|Total|Total of all reporting groups
317200|NCT00838279|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
317201|NCT00838279|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
317202|NCT00838279|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
317203|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317204|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317205|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317206|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317207|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317208|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317209|NCT00838201|B3|Baseline|Total|Total of all reporting groups
317210|NCT00838201|B2|Baseline|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317211|NCT00838201|B1|Baseline|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317212|NCT00838201|P2|Participant Flow|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317213|NCT00838201|P1|Participant Flow|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317214|NCT00838201|O2|Outcome|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317215|NCT00838201|O1|Outcome|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317216|NCT00838201|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317217|NCT00838201|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
317218|NCT00838162|B5|Baseline|Total|Total of all reporting groups
317219|NCT00838162|B4|Baseline|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317220|NCT00838162|B3|Baseline|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317221|NCT00838162|B2|Baseline|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317222|NCT00838162|B1|Baseline|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317223|NCT00838162|P4|Participant Flow|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317224|NCT00838162|P3|Participant Flow|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317225|NCT00838162|P2|Participant Flow|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317226|NCT00838162|P1|Participant Flow|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317227|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317228|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317229|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317230|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317231|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317232|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317233|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317234|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317235|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317236|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317237|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317238|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317239|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317240|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317241|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317242|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317243|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317244|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317245|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317246|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317247|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317248|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
319643|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
317253|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317254|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317255|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317256|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317257|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317258|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317259|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317260|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317261|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317262|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317263|NCT00838162|E4|Reported Event|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
317264|NCT00838162|E3|Reported Event|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
317265|NCT00838162|E2|Reported Event|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
317266|NCT00838162|E1|Reported Event|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
317267|NCT00838136|B3|Baseline|Total|Total of all reporting groups
317268|NCT00838136|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
317269|NCT00838136|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
317270|NCT00838136|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
317271|NCT00838136|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
317272|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317273|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317274|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317275|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317276|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
317277|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
317278|NCT00838110|B3|Baseline|Total|Total of all reporting groups
317279|NCT00838110|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
317280|NCT00838110|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
317281|NCT00838110|P4|Participant Flow|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
317282|NCT00838110|P3|Participant Flow|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
317283|NCT00838110|P2|Participant Flow|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
317284|NCT00838110|P1|Participant Flow|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
317285|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
317286|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
317287|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
317288|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
317289|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
317290|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
317291|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
317292|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
317293|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
317294|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
317295|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
317296|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
317297|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
317298|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
317299|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
317300|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
317301|NCT00838110|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
317302|NCT00838110|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
317303|NCT00838097|B1|Baseline|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317304|NCT00838097|P1|Participant Flow|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317305|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317306|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317307|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317308|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317309|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317310|NCT00838097|E1|Reported Event|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
317311|NCT00837967|B1|Baseline|All Study Participants|
317312|NCT00837967|P2|Participant Flow|Terbutaline First, Then Symbicort|Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
317313|NCT00837967|P1|Participant Flow|Symbicort First, Then Terbutaline|Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
317314|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317315|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317316|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317317|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317318|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317319|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317320|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317321|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317322|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317323|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317324|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
317325|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
317326|NCT00837967|E2|Reported Event|Terbutaline|Terbutaline Turbuhaler 0.4 mg for 3 days
317327|NCT00837967|E1|Reported Event|Symbicort|Symbicort Turbuhaler 160/4.5μg for 3 days
317328|NCT00837876|B1|Baseline|Treatment|Sorafenib + Erlotinib
317329|NCT00837876|P1|Participant Flow|Treatment|Sorafenib + Erlotinib
317330|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
317331|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
317332|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
317333|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
317334|NCT00837876|E1|Reported Event|Treatment|Sorafenib + Erlotinib
317335|NCT00837824|B3|Baseline|Total|Total of all reporting groups
317336|NCT00837824|B2|Baseline|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
317337|NCT00837824|B1|Baseline|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
317338|NCT00837824|P2|Participant Flow|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
317340|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
317341|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
317342|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
317343|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
317344|NCT00837824|E3|Reported Event|Total|
317345|NCT00837824|E2|Reported Event|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
317346|NCT00837824|E1|Reported Event|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
317347|NCT00837759|B1|Baseline|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317348|NCT00837759|P1|Participant Flow|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317349|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317350|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317351|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317352|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317353|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317354|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317355|NCT00837759|E1|Reported Event|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
317356|NCT00837616|B3|Baseline|Total|Total of all reporting groups
317357|NCT00837616|B2|Baseline|Group B|Group B received the transdermal estradiol for 12 months
317358|NCT00837616|B1|Baseline|Group A|Group A received the oral estradiol for 12 months
317359|NCT00837616|P2|Participant Flow|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317360|NCT00837616|P1|Participant Flow|Oral Estradiol|Group A received the oral estradiol for 12 months
317361|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317362|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317363|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317364|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317365|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317366|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317367|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317368|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317369|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317370|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317371|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317372|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317373|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317374|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317375|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317376|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317377|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317378|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317379|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
317380|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
317381|NCT00837616|E2|Reported Event|Group B|Group B received the transdermal estradiol for 12 months
317382|NCT00837616|E1|Reported Event|Group A|Group A received the oral estradiol for 12 months
317383|NCT00837577|B3|Baseline|Total|Total of all reporting groups
317384|NCT00837577|B2|Baseline|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317385|NCT00837577|B1|Baseline|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
317386|NCT00837577|P2|Participant Flow|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317387|NCT00837577|P1|Participant Flow|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
317388|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317389|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
317390|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317391|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
319644|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
317392|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317393|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
317394|NCT00837577|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
317395|NCT00837577|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
317396|NCT00837577|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
317397|NCT00837512|B1|Baseline|Entire Study Population|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
317398|NCT00837512|P2|Participant Flow|First: Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
317399|NCT00837512|P1|Participant Flow|First: Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
317400|NCT00837512|O2|Outcome|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
317401|NCT00837512|O1|Outcome|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
317402|NCT00837512|E2|Reported Event|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
317403|NCT00837512|E1|Reported Event|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
317404|NCT00837486|B3|Baseline|Total|Total of all reporting groups
317405|NCT00837486|B2|Baseline|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317406|NCT00837486|B1|Baseline|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317407|NCT00837486|P2|Participant Flow|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317408|NCT00837486|P1|Participant Flow|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317409|NCT00837486|O1|Outcome|All Enrolled Subjects|The 30 subjects were followed an average of 36 months after enrollment.
317410|NCT00837486|O1|Outcome|Long-term Open-label Treatment|All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
317411|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317412|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317413|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317414|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317415|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317416|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317417|NCT00837486|E2|Reported Event|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
317418|NCT00837486|E1|Reported Event|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
317419|NCT00837447|B1|Baseline|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
317420|NCT00837447|P1|Participant Flow|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
317421|NCT00837447|O2|Outcome|High-Flexion Posterior Cruciate Scrificing TKA|
317422|NCT00837447|O1|Outcome|High-Flexion Posterior Cruciate Retaining TKA|
317423|NCT00837447|E1|Reported Event|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
317424|NCT00837434|B3|Baseline|Total|Total of all reporting groups
317425|NCT00837434|B2|Baseline|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317426|NCT00837434|B1|Baseline|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317427|NCT00837434|P2|Participant Flow|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317428|NCT00837434|P1|Participant Flow|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317429|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317430|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317431|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317535|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317432|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317433|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317434|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317435|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317436|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317437|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317438|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317439|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317440|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317441|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317442|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317443|NCT00837434|E2|Reported Event|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
317444|NCT00837434|E1|Reported Event|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
317445|NCT00837330|B3|Baseline|Total|Total of all reporting groups
317446|NCT00837330|B2|Baseline|Ranibizumab 0.3 mg/ 0.05 cc|Intraocular injection of 0.3 mg /0.05 cc ranibizumab
317447|NCT00837330|B1|Baseline|Ranibizumab 0.5 mg/ 0.05 cc|Intraocular injection of 0.5 mg /0.05 cc ranibizumab
317448|NCT00837330|P2|Participant Flow|Intraocular Injection 0.3 mg Ranibizumab|10 patients will receive intraocular injection 0.3 mg ranibizumab
317449|NCT00837330|P1|Participant Flow|Intraocular Injection 0.5 mg Ranibizumab|10 patients will receive intraocular injection 0.5 mg ranibizumab
317450|NCT00837330|O2|Outcome|Ranibizumab 0.3 mg|Intraocular injection 0.3 mg ranibizumab
317451|NCT00837330|O1|Outcome|Ranibizumab 0.5 mg|Intraocular injection of 0.5 mg ranibizumab
317452|NCT00837330|E2|Reported Event|Ranibizumab 0.3 mg|Intravitreal Injection of Ranibizumab 0.5 mg
317453|NCT00837330|E1|Reported Event|Ranibizumab 0.5 mg|Intravitreal Injection of Ranibizumab 0.5 mg
317454|NCT00837252|B1|Baseline|Finasteride|
317455|NCT00837252|P1|Participant Flow|Finasteride|All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
317456|NCT00837252|O1|Outcome|Finasteride|
317457|NCT00837252|O1|Outcome|Finasteride|
317458|NCT00837252|O1|Outcome|Finasteride|
317459|NCT00837252|O1|Outcome|Finasteride|
317460|NCT00837252|O1|Outcome|Finasteride|
317461|NCT00837252|O1|Outcome|Finasteride|
317462|NCT00837252|O1|Outcome|Finasteride|
317463|NCT00837252|O1|Outcome|Finasteride|
317464|NCT00837252|O1|Outcome|Finasteride|
317465|NCT00837252|O1|Outcome|Finasteride|
317466|NCT00837252|O1|Outcome|Finasteride|
317467|NCT00837252|O1|Outcome|Finasteride|
317468|NCT00837252|E1|Reported Event|Finasteride|
317469|NCT00837213|B3|Baseline|Total|Total of all reporting groups
317470|NCT00837213|B2|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317471|NCT00837213|B1|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317472|NCT00837213|P2|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317473|NCT00837213|P1|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317474|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317475|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317476|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317477|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317478|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317479|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317480|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317481|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317482|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317483|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317484|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317485|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317486|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317487|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317488|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317489|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317490|NCT00837213|E2|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
317491|NCT00837213|E1|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
317492|NCT00837200|B1|Baseline|Treatment|Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
317493|NCT00837200|P1|Participant Flow|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
317494|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
317495|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
317496|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
317497|NCT00837200|E1|Reported Event|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
317498|NCT00837161|B1|Baseline|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317499|NCT00837161|P1|Participant Flow|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317500|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317501|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317502|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317503|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317536|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317537|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317504|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
317505|NCT00837161|E1|Reported Event|HIFU Treatment|
317506|NCT00837148|B1|Baseline|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
317507|NCT00837148|P1|Participant Flow|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
317508|NCT00837148|O1|Outcome|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
317509|NCT00837148|E1|Reported Event|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
317510|NCT00837031|B1|Baseline|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317511|NCT00837031|P1|Participant Flow|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317512|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317513|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317514|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317515|NCT00837031|E1|Reported Event|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
317516|NCT00836953|B1|Baseline|Study Group|Participants received study vaccine on Days 0 and 30.
317517|NCT00836953|P1|Participant Flow|Study Group|Participants received study vaccine on Days 0 and 30.
317518|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
317519|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
317520|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
317521|NCT00836953|E1|Reported Event|Study Group|Participants received study vaccine on Days 0 and 30.
317522|NCT00836901|B3|Baseline|Total|Total of all reporting groups
317523|NCT00836901|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
317524|NCT00836901|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
317525|NCT00836901|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
317526|NCT00836901|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
317527|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317528|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317529|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317530|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317531|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317532|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317533|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317534|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
319645|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
317538|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317539|NCT00836875|B3|Baseline|Total|Total of all reporting groups
317540|NCT00836875|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317541|NCT00836875|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317542|NCT00836875|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317543|NCT00836875|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317544|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317545|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317546|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317547|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317548|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317549|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317550|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317551|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317552|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317553|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317554|NCT00836875|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
317584|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317555|NCT00836875|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
317556|NCT00836745|B1|Baseline|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317557|NCT00836745|P1|Participant Flow|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317558|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317559|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317560|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317561|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317562|NCT00836745|E1|Reported Event|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
317563|NCT00836719|B1|Baseline|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
317564|NCT00836719|P1|Participant Flow|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
317565|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
317566|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
317567|NCT00836719|E1|Reported Event|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
317568|NCT00836706|B3|Baseline|Total|Total of all reporting groups
317569|NCT00836706|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
317570|NCT00836706|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
317571|NCT00836706|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
317572|NCT00836706|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
317573|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317574|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
317575|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317576|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
317577|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317578|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
317579|NCT00836693|B3|Baseline|Total|Total of all reporting groups
317580|NCT00836693|B2|Baseline|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317581|NCT00836693|B1|Baseline|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317582|NCT00836693|P2|Participant Flow|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317583|NCT00836693|P1|Participant Flow|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317725|NCT00836355|E4|Reported Event|Control|
317585|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317586|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317587|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317588|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317589|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317590|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317591|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317592|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317593|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317594|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317595|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317596|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317597|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317598|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317599|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317600|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317601|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317602|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317603|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317604|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317605|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317606|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317607|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317608|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317609|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317610|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317611|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317612|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317613|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317614|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317799|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
319646|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
317615|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317616|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317617|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317618|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
317619|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317620|NCT00836693|E2|Reported Event|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
317621|NCT00836693|E1|Reported Event|Tadalafil|Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
317622|NCT00836641|B3|Baseline|Total|Total of all reporting groups
317623|NCT00836641|B2|Baseline|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
317624|NCT00836641|B1|Baseline|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
317625|NCT00836641|P2|Participant Flow|Group B: Sequential Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
317626|NCT00836641|P1|Participant Flow|Group A: Sequential Pneumococcal Immunzation (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
317627|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
317628|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
317629|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
317630|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
317631|NCT00836641|E1|Reported Event|Overall Study Population|the whole study population was observed for adverse events.
317632|NCT00836498|B3|Baseline|Total|Total of all reporting groups
317633|NCT00836498|B2|Baseline|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317634|NCT00836498|B1|Baseline|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317635|NCT00836498|P2|Participant Flow|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317636|NCT00836498|P1|Participant Flow|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317637|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317638|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317639|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317640|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317641|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317642|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317643|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317644|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317645|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317646|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317647|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317648|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317649|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317650|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317651|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317652|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317653|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317654|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317655|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317656|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317657|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317658|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317659|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317660|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317661|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317662|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317663|NCT00836498|E2|Reported Event|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317664|NCT00836498|E1|Reported Event|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
317665|NCT00836472|B3|Baseline|Total|Total of all reporting groups
317666|NCT00836472|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
317667|NCT00836472|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
317668|NCT00836472|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
317669|NCT00836472|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
317670|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317671|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317672|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317673|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317674|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317675|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317676|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317677|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317678|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317679|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317680|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317681|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
317682|NCT00836433|B3|Baseline|Total|Total of all reporting groups
317683|NCT00836433|B2|Baseline|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317800|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317684|NCT00836433|B1|Baseline|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317685|NCT00836433|P2|Participant Flow|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317686|NCT00836433|P1|Participant Flow|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317687|NCT00836433|O2|Outcome|CONNECT and FALLS|"CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317688|NCT00836433|O1|Outcome|FALLS Only|"Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317689|NCT00836433|O2|Outcome|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317690|NCT00836433|O1|Outcome|FALLS|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317691|NCT00836433|E2|Reported Event|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317692|NCT00836433|E1|Reported Event|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
317693|NCT00836407|B3|Baseline|Total|Total of all reporting groups
317694|NCT00836407|B2|Baseline|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
317695|NCT00836407|B1|Baseline|Arm 1: Ipilimumab Alone|Ipilimumab alone
317696|NCT00836407|P2|Participant Flow|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
317697|NCT00836407|P1|Participant Flow|Arm 1: Ipilimumab Alone|Ipilimumab alone
317698|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
317699|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
317700|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
317701|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
317702|NCT00836407|E2|Reported Event|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
317703|NCT00836407|E1|Reported Event|Arm 1: Ipilimumab Alone|Ipilimumab alone
317704|NCT00836355|B5|Baseline|Total|Total of all reporting groups
317705|NCT00836355|B4|Baseline|Control|
317706|NCT00836355|B3|Baseline|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317707|NCT00836355|B2|Baseline|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317708|NCT00836355|B1|Baseline|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317709|NCT00836355|P4|Participant Flow|Control|
317710|NCT00836355|P3|Participant Flow|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317711|NCT00836355|P2|Participant Flow|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317712|NCT00836355|P1|Participant Flow|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317713|NCT00836355|O4|Outcome|Control|
317714|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317715|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317716|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317717|NCT00836355|O4|Outcome|Control|
317718|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317719|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317720|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317721|NCT00836355|O4|Outcome|Control|
317722|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317723|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317724|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317726|NCT00836355|E3|Reported Event|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
317727|NCT00836355|E2|Reported Event|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
317728|NCT00836355|E1|Reported Event|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
317729|NCT00836342|B4|Baseline|Total|Total of all reporting groups
317730|NCT00836342|B3|Baseline|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
317731|NCT00836342|B2|Baseline|Previous History of BCC|Participants had previous history of basal cell carcinoma
317732|NCT00836342|B1|Baseline|Previous History of SCC|Participants had previous history of squamous cell carcinoma
317733|NCT00836342|P3|Participant Flow|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
317734|NCT00836342|P2|Participant Flow|Previous History of BCC|Participants had previous history of basal cell carcinoma
317735|NCT00836342|P1|Participant Flow|Previous History of SCC|Participants had previous history of squamous cell carcinoma
317736|NCT00836342|O2|Outcome|Control Group|Participants had no history of previous squamous cell carcinoma or basal cell carcinoma
317737|NCT00836342|O1|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
317738|NCT00836342|O2|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
317739|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
317740|NCT00836342|O2|Outcome|Control Group|Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
317741|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
317742|NCT00836342|E3|Reported Event|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
317743|NCT00836342|E2|Reported Event|Previous History of BCC|Participants had previous history of basal cell carcinoma
317744|NCT00836342|E1|Reported Event|Previous History of SCC|Participants had previous history of squamous cell carcinoma
317745|NCT00836277|B1|Baseline|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317746|NCT00836277|P1|Participant Flow|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317747|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317748|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317749|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317750|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317751|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317752|NCT00836277|E1|Reported Event|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
317753|NCT00836095|B3|Baseline|Total|Total of all reporting groups
317754|NCT00836095|B2|Baseline|Proseal LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
317755|NCT00836095|B1|Baseline|Supreme LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant."
317756|NCT00836095|P2|Participant Flow|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317757|NCT00836095|P1|Participant Flow|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317758|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317759|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317798|NCT00835991|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
317760|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317761|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
317762|NCT00836095|E2|Reported Event|Proseal LMA|"Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
317763|NCT00836095|E1|Reported Event|Supreme LMA|"Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant"
317764|NCT00836056|B3|Baseline|Total|Total of all reporting groups
317765|NCT00836056|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
317766|NCT00836056|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
317767|NCT00836056|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
317768|NCT00836056|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
317769|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317770|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317771|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317772|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317773|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317774|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317775|NCT00836017|B1|Baseline|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317776|NCT00836017|P1|Participant Flow|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317777|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317778|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317779|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317780|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317781|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317782|NCT00836017|E1|Reported Event|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
317783|NCT00836004|B3|Baseline|Total|Total of all reporting groups
317784|NCT00836004|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
317785|NCT00836004|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
317786|NCT00836004|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
317787|NCT00836004|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
317788|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317789|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317790|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317791|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317792|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
317793|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
317794|NCT00835991|B3|Baseline|Total|Total of all reporting groups
317795|NCT00835991|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
317796|NCT00835991|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
317797|NCT00835991|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
319647|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
317801|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317802|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317803|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317804|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317805|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317806|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317807|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317808|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317809|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
317810|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
317811|NCT00835978|B5|Baseline|Total|Total of all reporting groups
317812|NCT00835978|B4|Baseline|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
317813|NCT00835978|B3|Baseline|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317814|NCT00835978|B2|Baseline|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317815|NCT00835978|B1|Baseline|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317816|NCT00835978|P4|Participant Flow|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
317817|NCT00835978|P3|Participant Flow|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317818|NCT00835978|P2|Participant Flow|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317819|NCT00835978|P1|Participant Flow|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317820|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317821|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317822|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317823|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317824|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317825|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317826|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317882|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
319648|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
317827|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317828|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317829|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317830|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317831|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317832|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317833|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317834|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317835|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317836|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317837|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317838|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317839|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317840|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317841|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317842|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317883|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317884|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
317885|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
319649|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
317843|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317844|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317845|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317846|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317847|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317848|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317849|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317850|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317851|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317852|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317853|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317854|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317855|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317856|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317886|NCT00835926|E2|Reported Event|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
319650|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
317857|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317858|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317859|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317860|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317861|NCT00835978|O1|Outcome|All Participants|All enrolled participants (randomized and non-randomized) who received at least one dose of study medication.
317862|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317863|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317864|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317865|NCT00835978|O1|Outcome|All Participants|All enrolled participants (randomized and non-randomized) who received at least one dose of study medication.
317866|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317867|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317868|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317869|NCT00835978|E4|Reported Event|Discontinued Prior to Randomization|Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
317870|NCT00835978|E3|Reported Event|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
317871|NCT00835978|E2|Reported Event|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
317872|NCT00835978|E1|Reported Event|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
317873|NCT00835926|B3|Baseline|Total|Total of all reporting groups
317874|NCT00835926|B2|Baseline|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
317875|NCT00835926|B1|Baseline|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317876|NCT00835926|P2|Participant Flow|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
317877|NCT00835926|P1|Participant Flow|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317878|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
317879|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317880|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
317881|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317887|NCT00835926|E1|Reported Event|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
317888|NCT00835861|B3|Baseline|Total|Total of all reporting groups
317889|NCT00835861|B2|Baseline|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
317890|NCT00835861|B1|Baseline|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.
317891|NCT00835861|P2|Participant Flow|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
317892|NCT00835861|P1|Participant Flow|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone
317893|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317894|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317895|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317896|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317897|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317898|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317899|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317900|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317901|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317962|NCT00835692|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
317902|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317903|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317904|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317905|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317906|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317907|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317908|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317909|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317910|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317911|NCT00835861|E2|Reported Event|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
317912|NCT00835861|E1|Reported Event|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
317913|NCT00835796|B3|Baseline|Total|Total of all reporting groups
317914|NCT00835796|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
317915|NCT00835796|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
317916|NCT00835796|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
317917|NCT00835796|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
317918|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
317919|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
317920|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
317921|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
317922|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
317923|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
317924|NCT00835731|B3|Baseline|Total|Total of all reporting groups
317963|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317964|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
317925|NCT00835731|B2|Baseline|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317926|NCT00835731|B1|Baseline|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317927|NCT00835731|P2|Participant Flow|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317928|NCT00835731|P1|Participant Flow|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317929|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317930|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317931|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317932|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317933|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317934|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317935|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317936|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317937|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317938|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317939|NCT00835731|E2|Reported Event|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
317940|NCT00835731|E1|Reported Event|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
317941|NCT00835705|B3|Baseline|Total|Total of all reporting groups
317942|NCT00835705|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
317943|NCT00835705|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
317944|NCT00835705|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
317945|NCT00835705|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
317946|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317947|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317948|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317949|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317950|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317951|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317952|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317953|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317954|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317955|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317956|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
317957|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
317958|NCT00835692|B3|Baseline|Total|Total of all reporting groups
317959|NCT00835692|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
317960|NCT00835692|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
317961|NCT00835692|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
317965|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317966|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
317967|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
317968|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
317969|NCT00835679|B5|Baseline|Total|Total of all reporting groups
317970|NCT00835679|B4|Baseline|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317971|NCT00835679|B3|Baseline|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317972|NCT00835679|B2|Baseline|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317973|NCT00835679|B1|Baseline|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317974|NCT00835679|P4|Participant Flow|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317975|NCT00835679|P3|Participant Flow|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317976|NCT00835679|P2|Participant Flow|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317977|NCT00835679|P1|Participant Flow|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317978|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317979|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317980|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317981|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317982|NCT00835679|O4|Outcome|Cetuximab + Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317983|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
317984|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317985|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317986|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317987|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317988|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317989|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317990|NCT00835679|O4|Outcome|Cetuximab +Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317991|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317992|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317993|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317994|NCT00835679|E4|Reported Event|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
317995|NCT00835679|E3|Reported Event|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
317996|NCT00835679|E2|Reported Event|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
317997|NCT00835679|E1|Reported Event|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
317998|NCT00835666|B3|Baseline|Total|Total of all reporting groups
317999|NCT00835666|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
318000|NCT00835666|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
318001|NCT00835666|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
318002|NCT00835666|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
318003|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
318004|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
318005|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
318006|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
318007|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
318008|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
318009|NCT00835640|B3|Baseline|Total|Total of all reporting groups
318010|NCT00835640|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
318011|NCT00835640|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
318012|NCT00835640|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
318013|NCT00835640|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
318014|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318015|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318016|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318017|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318018|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318019|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318020|NCT00835614|B3|Baseline|Total|Total of all reporting groups
318021|NCT00835614|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
318022|NCT00835614|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
318023|NCT00835614|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
318024|NCT00835614|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
318025|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318026|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318027|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318028|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318029|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318030|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318031|NCT00835588|B3|Baseline|Total|Total of all reporting groups
318032|NCT00835588|B2|Baseline|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
318033|NCT00835588|B1|Baseline|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
318034|NCT00835588|P2|Participant Flow|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
318035|NCT00835588|P1|Participant Flow|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
318036|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
318037|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
318038|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
322505|NCT00824382|O1|Outcome|Placebo|Placebo
318039|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
318040|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
318041|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
318042|NCT00835575|B3|Baseline|Total|Total of all reporting groups
318043|NCT00835575|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
318044|NCT00835575|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
318045|NCT00835575|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
318046|NCT00835575|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
318047|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
318048|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
318049|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
318050|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
318051|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
318052|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
318053|NCT00835549|B3|Baseline|Total|Total of all reporting groups
318054|NCT00835549|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
318055|NCT00835549|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
318056|NCT00835549|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
318057|NCT00835549|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
318058|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318059|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318060|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318061|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318062|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318063|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318064|NCT00835536|B3|Baseline|Total|Total of all reporting groups
318065|NCT00835536|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
318066|NCT00835536|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
318067|NCT00835536|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
318068|NCT00835536|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
318069|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
318070|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
318071|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
318072|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
318073|NCT00835510|B4|Baseline|Total|Total of all reporting groups
318074|NCT00835510|B3|Baseline|Vehicle|Butenafine vehicle applied for 7 days
318075|NCT00835510|B2|Baseline|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318076|NCT00835510|B1|Baseline|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318077|NCT00835510|P3|Participant Flow|Vehicle|Butenafine vehicle applied for 7 days
318078|NCT00835510|P2|Participant Flow|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318079|NCT00835510|P1|Participant Flow|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318080|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
318081|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318082|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318083|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
318084|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318085|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318086|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
318087|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318088|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318089|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
318090|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318091|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318092|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
318093|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318094|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318095|NCT00835510|E3|Reported Event|Vehicle|Butenafine vehicle applied for 7 days
318096|NCT00835510|E2|Reported Event|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
318097|NCT00835510|E1|Reported Event|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
318098|NCT00835497|B3|Baseline|Total|Total of all reporting groups
318099|NCT00835497|B2|Baseline|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
318100|NCT00835497|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
318101|NCT00835497|P2|Participant Flow|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
318102|NCT00835497|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
318103|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318104|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318105|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318106|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318107|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318108|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318109|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318110|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318111|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318112|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318113|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
318114|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318115|NCT00835484|B3|Baseline|Total|Total of all reporting groups
318116|NCT00835484|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
318117|NCT00835484|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
318118|NCT00835484|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
318119|NCT00835484|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
318120|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
318121|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318122|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
318123|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318124|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
318125|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318126|NCT00835406|B3|Baseline|Total|Total of all reporting groups
318127|NCT00835406|B2|Baseline|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
318128|NCT00835406|B1|Baseline|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
318129|NCT00835406|P2|Participant Flow|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
318130|NCT00835406|P1|Participant Flow|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
318131|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
318132|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
318133|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
318134|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
318135|NCT00835380|B1|Baseline|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
318136|NCT00835380|P1|Participant Flow|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
318137|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
318138|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
318139|NCT00835380|E1|Reported Event|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
318140|NCT00835367|B3|Baseline|Total|Total of all reporting groups
318141|NCT00835367|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
318142|NCT00835367|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
318143|NCT00835367|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
318144|NCT00835367|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
318145|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318146|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318147|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318148|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318149|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318150|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318151|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318152|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318153|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318154|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318155|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318156|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318157|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318158|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318159|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318160|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318161|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318162|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
318163|NCT00835354|B3|Baseline|Total|Total of all reporting groups
318164|NCT00835354|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
318165|NCT00835354|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
318166|NCT00835354|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
318167|NCT00835354|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
318168|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318169|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318170|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318171|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318172|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
318173|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
318174|NCT00835341|B3|Baseline|Total|Total of all reporting groups
318175|NCT00835341|B2|Baseline|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
318176|NCT00835341|B1|Baseline|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
318177|NCT00835341|P2|Participant Flow|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
318178|NCT00835341|P1|Participant Flow|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
318179|NCT00835341|O2|Outcome|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
318180|NCT00835341|O1|Outcome|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
318181|NCT00835341|E2|Reported Event|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
318182|NCT00835341|E1|Reported Event|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
318183|NCT00835276|B3|Baseline|Total|Total of all reporting groups
318184|NCT00835276|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
318302|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
318185|NCT00835276|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
318186|NCT00835276|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
318187|NCT00835276|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
318188|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318189|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318190|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318191|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318192|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
318193|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
318194|NCT00835263|B3|Baseline|Total|Total of all reporting groups
318195|NCT00835263|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
318196|NCT00835263|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
318197|NCT00835263|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
318198|NCT00835263|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
318199|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318200|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318201|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318202|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318203|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318204|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318205|NCT00835237|B3|Baseline|Total|Total of all reporting groups
318206|NCT00835237|B2|Baseline|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318207|NCT00835237|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318208|NCT00835237|P2|Participant Flow|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318209|NCT00835237|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318210|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318211|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318212|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318213|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318214|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318215|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318216|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318217|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318218|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318219|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318220|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318221|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318222|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318223|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318224|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318225|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318226|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318227|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318228|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318229|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318230|NCT00835237|E2|Reported Event|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
318231|NCT00835237|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
318232|NCT00835224|B1|Baseline|All Participants|All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
318233|NCT00835224|P1|Participant Flow|All Participants|All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
318234|NCT00835224|O6|Outcome|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
318235|NCT00835224|O5|Outcome|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
318236|NCT00835224|O4|Outcome|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
318237|NCT00835224|O3|Outcome|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
318238|NCT00835224|O2|Outcome|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
318239|NCT00835224|O1|Outcome|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
318240|NCT00835224|E6|Reported Event|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
318241|NCT00835224|E5|Reported Event|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
318242|NCT00835224|E4|Reported Event|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
318243|NCT00835224|E3|Reported Event|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
318244|NCT00835224|E2|Reported Event|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
318245|NCT00835224|E1|Reported Event|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
318246|NCT00835211|B3|Baseline|Total|Total of all reporting groups
318247|NCT00835211|B2|Baseline|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
318248|NCT00835211|B1|Baseline|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
318249|NCT00835211|P2|Participant Flow|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
318250|NCT00835211|P1|Participant Flow|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
318251|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
318252|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
318253|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
318254|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
318255|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
318256|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
318257|NCT00835198|B3|Baseline|Total|Total of all reporting groups
318258|NCT00835198|B2|Baseline|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318259|NCT00835198|B1|Baseline|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318260|NCT00835198|P2|Participant Flow|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318261|NCT00835198|P1|Participant Flow|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318262|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318263|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318264|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318265|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318266|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318267|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318268|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318269|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318270|NCT00835198|E2|Reported Event|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
318271|NCT00835198|E1|Reported Event|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
318272|NCT00835185|B1|Baseline|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318273|NCT00835185|P1|Participant Flow|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes~85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met."
318274|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318275|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318276|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318277|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318278|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318279|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318280|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318281|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
318282|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
318283|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
318303|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
318304|NCT00835159|B3|Baseline|Total|Total of all reporting groups
318331|NCT00835081|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
318332|NCT00835081|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
318284|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
318285|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
318286|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318287|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318288|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318289|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318290|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318291|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318292|NCT00835185|E1|Reported Event|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
318293|NCT00835172|B3|Baseline|Total|Total of all reporting groups
318294|NCT00835172|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
318295|NCT00835172|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
318296|NCT00835172|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
318297|NCT00835172|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
318298|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
318299|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
318300|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
318301|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
318305|NCT00835159|B2|Baseline|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
318306|NCT00835159|B1|Baseline|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
318307|NCT00835159|P2|Participant Flow|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
318308|NCT00835159|P1|Participant Flow|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
318309|NCT00835159|O2|Outcome|Placebo Patch|Eligible patients received a placebo patch
318310|NCT00835159|O1|Outcome|Rivastigmine Patch|Eligible patients received a rivastigmine 5-cm2 transdermal patch
318311|NCT00835159|E2|Reported Event|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
318312|NCT00835159|E1|Reported Event|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
318313|NCT00835146|B3|Baseline|Total|Total of all reporting groups
318314|NCT00835146|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
318315|NCT00835146|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
318316|NCT00835146|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
318317|NCT00835146|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
318318|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
318319|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
318320|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
318321|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
318322|NCT00835120|B1|Baseline|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318323|NCT00835120|P1|Participant Flow|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318324|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318325|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318326|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318327|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318328|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318329|NCT00835120|E1|Reported Event|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
318330|NCT00835081|B3|Baseline|Total|Total of all reporting groups
318333|NCT00835081|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
318334|NCT00835081|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
318335|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
318336|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
318337|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
318338|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
318339|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
318340|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
318341|NCT00835068|B3|Baseline|Total|Total of all reporting groups
318342|NCT00835068|B2|Baseline|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318343|NCT00835068|B1|Baseline|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318344|NCT00835068|P2|Participant Flow|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318345|NCT00835068|P1|Participant Flow|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318346|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318347|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318348|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318349|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318350|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318351|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318352|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318353|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318354|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318355|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318356|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318357|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318358|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318359|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318360|NCT00835068|E2|Reported Event|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
318361|NCT00835068|E1|Reported Event|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
318362|NCT00835042|B3|Baseline|Total|Total of all reporting groups
318363|NCT00835042|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
323403|NCT00822354|O2|Outcome|Week 4 of Treatment|
318364|NCT00835042|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
318365|NCT00835042|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
318366|NCT00835042|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
318367|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318368|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318369|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318370|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318371|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318372|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318373|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318374|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318375|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318376|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318377|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318378|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318379|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318380|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318381|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318382|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318383|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
318384|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
318385|NCT00835003|B3|Baseline|Total|Total of all reporting groups
318386|NCT00835003|B2|Baseline|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
318387|NCT00835003|B1|Baseline|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
318388|NCT00835003|P2|Participant Flow|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
318389|NCT00835003|P1|Participant Flow|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
318390|NCT00835003|O2|Outcome|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
318391|NCT00835003|O1|Outcome|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
318392|NCT00835003|E2|Reported Event|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
318393|NCT00835003|E1|Reported Event|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
318394|NCT00834990|B3|Baseline|Total|Total of all reporting groups
318395|NCT00834990|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
318396|NCT00834990|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
318397|NCT00834990|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
318398|NCT00834990|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
318399|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318400|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318401|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318402|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318403|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318404|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318405|NCT00834977|B3|Baseline|Total|Total of all reporting groups
318406|NCT00834977|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
318407|NCT00834977|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
318408|NCT00834977|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
318409|NCT00834977|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
318410|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318411|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318412|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318413|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318414|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318415|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318416|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318417|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318418|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318419|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318420|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318421|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318422|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318423|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318424|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318425|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318426|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
318427|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
318428|NCT00834964|B3|Baseline|Total|Total of all reporting groups
318429|NCT00834964|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
318430|NCT00834964|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
318431|NCT00834964|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
318432|NCT00834964|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
318433|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318434|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318435|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318436|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318437|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318438|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318439|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318440|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318441|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318442|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318443|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
318444|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
318445|NCT00834912|B7|Baseline|Total|Total of all reporting groups
318446|NCT00834912|B6|Baseline|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
318447|NCT00834912|B5|Baseline|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
318448|NCT00834912|B4|Baseline|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
318449|NCT00834912|B3|Baseline|Confab Fed / Confab Fasting / Trillium Fasting|Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
318558|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318450|NCT00834912|B2|Baseline|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
318451|NCT00834912|B1|Baseline|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
318452|NCT00834912|P6|Participant Flow|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
318453|NCT00834912|P5|Participant Flow|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
318454|NCT00834912|P4|Participant Flow|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
318455|NCT00834912|P3|Participant Flow|Confab Fed / Confab Fasting / Trillium Fasting|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
318456|NCT00834912|P2|Participant Flow|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
318457|NCT00834912|P1|Participant Flow|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
318458|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318459|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
318460|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318461|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318462|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
323404|NCT00822354|O1|Outcome|Pre-treatment|
318463|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318464|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318465|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
318466|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318467|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318468|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
318469|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318470|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318471|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
318472|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318473|NCT00834912|E3|Reported Event|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
318509|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318510|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
323405|NCT00822354|O4|Outcome|Week 4 of Placebo|
318474|NCT00834912|E2|Reported Event|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
318475|NCT00834912|E1|Reported Event|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
318476|NCT00834899|B3|Baseline|Total|Total of all reporting groups
318477|NCT00834899|B2|Baseline|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318478|NCT00834899|B1|Baseline|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318479|NCT00834899|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318480|NCT00834899|P1|Participant Flow|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318481|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318482|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318483|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318484|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318485|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318486|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318487|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318488|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318489|NCT00834899|E2|Reported Event|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
318490|NCT00834899|E1|Reported Event|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
318491|NCT00834886|B5|Baseline|Total|Total of all reporting groups
318492|NCT00834886|B4|Baseline|Placebo Melatonin and Placebo Light|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318493|NCT00834886|B3|Baseline|Placebo Melatonin and Light Therapy|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318494|NCT00834886|B2|Baseline|Melatonin and Placebo Light|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
318495|NCT00834886|B1|Baseline|Melatonin and Light Therapy|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318496|NCT00834886|P4|Participant Flow|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318497|NCT00834886|P3|Participant Flow|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318498|NCT00834886|P2|Participant Flow|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
318499|NCT00834886|P1|Participant Flow|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318500|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318501|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318502|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
318503|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318504|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318505|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318506|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
318507|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318508|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318511|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318512|NCT00834886|E4|Reported Event|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
318513|NCT00834886|E3|Reported Event|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318514|NCT00834886|E2|Reported Event|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
318515|NCT00834886|E1|Reported Event|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
318516|NCT00834873|B3|Baseline|Total|Total of all reporting groups
318517|NCT00834873|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
318518|NCT00834873|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
318519|NCT00834873|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
318520|NCT00834873|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
318521|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
318522|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318523|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
318524|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318525|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
318526|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318527|NCT00834808|B4|Baseline|Total|Total of all reporting groups
318528|NCT00834808|B3|Baseline|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318529|NCT00834808|B2|Baseline|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318530|NCT00834808|B1|Baseline|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318531|NCT00834808|P3|Participant Flow|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318532|NCT00834808|P2|Participant Flow|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318533|NCT00834808|P1|Participant Flow|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318534|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318535|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318536|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318537|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318538|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318539|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318540|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318541|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318542|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318543|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318544|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318545|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318546|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318547|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318548|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318549|NCT00834808|E3|Reported Event|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318550|NCT00834808|E2|Reported Event|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318551|NCT00834808|E1|Reported Event|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
318552|NCT00834795|B3|Baseline|Total|Total of all reporting groups
318553|NCT00834795|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
318554|NCT00834795|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
318555|NCT00834795|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
318556|NCT00834795|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
318557|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
323406|NCT00822354|O3|Outcome|Pre-placebo|
318559|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
318560|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318561|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
318562|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
318563|NCT00833794|B3|Baseline|Total|Total of all reporting groups
318564|NCT00833794|B2|Baseline|2 Placebo|
318565|NCT00833794|B1|Baseline|1 Tramadol Once A Day|
318566|NCT00833794|P2|Participant Flow|2 Placebo|
318567|NCT00833794|P1|Participant Flow|1 Tramadol Once A Day|
318568|NCT00833794|O2|Outcome|2 Placebo|
318569|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318570|NCT00833794|O2|Outcome|2 Placebo|
318571|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318572|NCT00833794|O2|Outcome|2 Placebo|
318573|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318574|NCT00833794|O2|Outcome|2 Placebo|
318575|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318576|NCT00833794|O2|Outcome|2 Placebo|
318577|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318578|NCT00833794|O2|Outcome|2 Placebo|
318579|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318580|NCT00833794|O2|Outcome|2 Placebo|
318581|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318582|NCT00833794|O4|Outcome|Tramadol Once A Day 300 mg|
318583|NCT00833794|O3|Outcome|Tramadol Once A Day 200 mg|
318584|NCT00833794|O2|Outcome|2 Placebo|
318585|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318586|NCT00833794|O2|Outcome|2 Placebo|
318587|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318588|NCT00833794|O2|Outcome|2 Placebo|
318589|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
318590|NCT00833794|E2|Reported Event|2 Placebo|
318591|NCT00833794|E1|Reported Event|1 Tramadol Once A Day|
318592|NCT00833781|B3|Baseline|Total|Total of all reporting groups
318593|NCT00833781|B2|Baseline|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
318594|NCT00833781|B1|Baseline|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
318595|NCT00833781|P2|Participant Flow|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
318596|NCT00833781|P1|Participant Flow|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
318597|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318598|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318599|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318600|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318601|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318602|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318603|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318604|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
318605|NCT00833781|E1|Reported Event|mRNA Transfected DCs|
318606|NCT00833755|B5|Baseline|Total|Total of all reporting groups
318607|NCT00833755|B4|Baseline|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318608|NCT00833755|B3|Baseline|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318609|NCT00833755|B2|Baseline|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318610|NCT00833755|B1|Baseline|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
318611|NCT00833755|P4|Participant Flow|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318612|NCT00833755|P3|Participant Flow|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318613|NCT00833755|P2|Participant Flow|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318614|NCT00833755|P1|Participant Flow|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
318615|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318616|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318617|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318618|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
318619|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318620|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318621|NCT00833755|O2|Outcome|Opioid - Placebo|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318622|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
318623|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318624|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318625|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318626|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
318627|NCT00833755|E4|Reported Event|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
318628|NCT00833755|E3|Reported Event|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
318629|NCT00833755|E2|Reported Event|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318630|NCT00833755|E1|Reported Event|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
318631|NCT00833703|B3|Baseline|Total|Total of all reporting groups
318632|NCT00833703|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318633|NCT00833703|B1|Baseline|Placebo|0.2 mL/kg/day matching placebo solution once daily
318634|NCT00833703|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318635|NCT00833703|P1|Participant Flow|Placebo|0.2 mL/kg/day matching placebo solution once daily
318636|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318637|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
318638|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318639|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
318640|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318641|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
318642|NCT00833703|E2|Reported Event|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
318643|NCT00833703|E1|Reported Event|Placebo|0.2 mL/kg/day matching placebo solution once daily
318644|NCT00833690|B4|Baseline|Total|Total of all reporting groups
318645|NCT00833690|B3|Baseline|[C.]Moderate|Inosine to produce a moderate urate elevation
318646|NCT00833690|B2|Baseline|[B:]Mild|Inosine to produce a mild urate elevation
318647|NCT00833690|B1|Baseline|[A:]Placebo|Placebo to produce no urate elevation
318648|NCT00833690|P3|Participant Flow|[C.]Moderate|Inosine to produce a moderate urate elevation
318649|NCT00833690|P2|Participant Flow|[B:]Mild|Inosine to produce a mild urate elevation
318650|NCT00833690|P1|Participant Flow|[A:]Placebo|Placebo to produce no urate elevation
318651|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318652|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318653|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318654|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318655|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318656|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318657|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318658|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318659|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318660|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318661|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318662|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318663|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318664|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318665|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318666|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318667|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318668|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318669|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318670|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318671|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318672|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318673|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318674|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318675|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318676|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318677|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318678|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318679|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318680|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318681|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318682|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318683|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318684|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318685|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318686|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318687|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318688|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318689|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318690|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318691|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318692|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318693|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318694|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318695|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318696|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318697|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318698|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318699|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318700|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318701|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318702|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318703|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318704|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318705|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318706|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318707|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318708|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318709|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318710|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318711|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318712|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318713|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318714|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318715|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318716|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318717|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318718|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318719|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318720|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318721|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318722|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318723|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318724|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318725|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318726|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318727|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318728|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318729|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318730|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318731|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318732|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318733|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318734|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318735|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318736|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318737|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318738|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318739|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318740|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318741|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318742|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318743|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318744|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318745|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318746|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318747|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318748|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318749|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318750|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318751|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318752|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318753|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318754|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318755|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318756|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318757|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318758|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318759|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318760|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318761|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318762|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318763|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318764|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318765|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
318766|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
318767|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
318768|NCT00833690|E3|Reported Event|[C.]Moderate|Inosine to produce a moderate urate elevation
318769|NCT00833690|E2|Reported Event|[B:]Mild|Inosine to produce a mild urate elevation
318770|NCT00833690|E1|Reported Event|[A:]Placebo|Placebo to produce no urate elevation
318771|NCT00833664|B3|Baseline|Total|Total of all reporting groups
318772|NCT00833664|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
318773|NCT00833664|B1|Baseline|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
318774|NCT00833664|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
318775|NCT00833664|P1|Participant Flow|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
318776|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318777|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
318778|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318779|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
318780|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318781|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
318782|NCT00833638|B4|Baseline|Total|Total of all reporting groups
318783|NCT00833638|B3|Baseline|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318784|NCT00833638|B2|Baseline|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318785|NCT00833638|B1|Baseline|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318786|NCT00833638|P3|Participant Flow|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318787|NCT00833638|P2|Participant Flow|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318788|NCT00833638|P1|Participant Flow|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318789|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318790|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318791|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318792|NCT00833638|O1|Outcome|Tadalafil 5 mg Double-blind|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318793|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318794|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318795|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318796|NCT00833638|O1|Outcome|Placebo Double-blind|No drug during baseline period, placeob for 14 days, then will continue at 5 mg for 14 days.
318797|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318798|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318799|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318800|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
319038|NCT00834405|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
318801|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318802|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318803|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318804|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318805|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318806|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318807|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318808|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318809|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318810|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318811|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318812|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318813|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318814|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318815|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318816|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318817|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318818|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
318819|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
318820|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
318821|NCT00833638|E6|Reported Event|Placebo to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
318822|NCT00833638|E5|Reported Event|Tadalafil 5 mg to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
318823|NCT00833638|E4|Reported Event|Tadalafil 2.5 mg to Tadalafil 5 mg|Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
318824|NCT00833638|E3|Reported Event|Placebo|No drug during baseline period followed by placebo for 14 days.
318825|NCT00833638|E2|Reported Event|Tadalafil 5 mg|No drug during baseline period followed by tadalafil 5 mg for 14 days.
318826|NCT00833638|E1|Reported Event|Tadalafil 2.5 mg|No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
318827|NCT00833586|B3|Baseline|Total|Total of all reporting groups
318828|NCT00833586|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
318829|NCT00833586|B1|Baseline|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
318830|NCT00833586|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
318831|NCT00833586|P1|Participant Flow|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
318832|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318833|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
318834|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318835|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
318836|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
318837|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
318838|NCT00833560|B1|Baseline|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318839|NCT00833560|P1|Participant Flow|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318840|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318841|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318842|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318843|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318844|NCT00833560|E1|Reported Event|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
318845|NCT00833547|B3|Baseline|Total|Total of all reporting groups
318846|NCT00833547|B2|Baseline|Placebo|placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
318847|NCT00833547|B1|Baseline|Eszopiclone|3mg of eszopiclone at bedtime on 2 consecutive nights
318848|NCT00833547|P2|Participant Flow|Eszopiclone|3mg of eszopiclone at bedtime for two consecutive nights
318849|NCT00833547|P1|Participant Flow|Placebo|placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
319039|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
318850|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
318851|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
318852|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
318853|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
318854|NCT00833547|E2|Reported Event|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
318855|NCT00833547|E1|Reported Event|Eszopiclone|3mg of eszopiclone on two consecutive nights
318856|NCT00834756|B3|Baseline|Total|Total of all reporting groups
318857|NCT00834756|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
318858|NCT00834756|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
318859|NCT00834756|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
318860|NCT00834756|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
318861|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
318862|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
318863|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
318864|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
318865|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
318866|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
318867|NCT00834743|B3|Baseline|Total|Total of all reporting groups
318868|NCT00834743|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
318869|NCT00834743|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
318870|NCT00834743|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
318871|NCT00834743|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
318872|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318873|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318874|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318875|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318876|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318877|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318878|NCT00834717|B3|Baseline|Total|Total of all reporting groups
318879|NCT00834717|B2|Baseline|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
318880|NCT00834717|B1|Baseline|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
318881|NCT00834717|P2|Participant Flow|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
318882|NCT00834717|P1|Participant Flow|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
318883|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
318884|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
318885|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
318886|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
318887|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
318888|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
318889|NCT00834678|B1|Baseline|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318890|NCT00834678|P1|Participant Flow|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
318891|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318892|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318927|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318928|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318893|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318894|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318895|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318896|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318897|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
318898|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
318899|NCT00834678|E1|Reported Event|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
318900|NCT00834639|B3|Baseline|Total|Total of all reporting groups
318901|NCT00834639|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
318902|NCT00834639|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
318903|NCT00834639|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
318904|NCT00834639|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
318905|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318906|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318907|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318908|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318909|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
318910|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
318911|NCT00834626|B1|Baseline|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318912|NCT00834626|P1|Participant Flow|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318913|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318914|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318915|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318916|NCT00834626|O1|Outcome|Percentage of Participants Not Requiring Insulin|Percentage of participants not requiring Insulin assessed at 1 year post-surgery
318917|NCT00834626|E1|Reported Event|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
318918|NCT00834613|B3|Baseline|Total|Total of all reporting groups
318919|NCT00834613|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
318920|NCT00834613|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
318921|NCT00834613|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
318922|NCT00834613|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
318923|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318924|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318925|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
318926|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
318930|NCT00834587|B2|Baseline|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
318931|NCT00834587|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
318932|NCT00834587|P2|Participant Flow|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
318933|NCT00834587|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
318934|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318935|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318936|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318937|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318938|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318939|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318940|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318941|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318942|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318943|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318944|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
318945|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
318946|NCT00834574|B3|Baseline|Total|Total of all reporting groups
318947|NCT00834574|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
318948|NCT00834574|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
318949|NCT00834574|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
318950|NCT00834574|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
318951|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318952|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318953|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318954|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318955|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
318956|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
318957|NCT00834561|B3|Baseline|Total|Total of all reporting groups
318958|NCT00834561|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
318959|NCT00834561|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
318960|NCT00834561|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
318961|NCT00834561|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
318962|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318963|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318964|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318965|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318966|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
318967|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
318968|NCT00834535|B3|Baseline|Total|Total of all reporting groups
318969|NCT00834535|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
318970|NCT00834535|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
318971|NCT00834535|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
318972|NCT00834535|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
318973|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
318974|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318975|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
319040|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
318976|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318977|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
318978|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
318979|NCT00834522|B3|Baseline|Total|Total of all reporting groups
318980|NCT00834522|B2|Baseline|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
318981|NCT00834522|B1|Baseline|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
318982|NCT00834522|P2|Participant Flow|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
318983|NCT00834522|P1|Participant Flow|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
318984|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
318985|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
318986|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
318987|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
318988|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
318989|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
318990|NCT00834483|B3|Baseline|Total|Total of all reporting groups
318991|NCT00834483|B2|Baseline|Control Group|Layered traditional wound closure (monocryl)
318992|NCT00834483|B1|Baseline|Treatment Group|Knotless suture for wound closure
318993|NCT00834483|P2|Participant Flow|Control Group|Layered traditional wound closure (monocryl)
318994|NCT00834483|P1|Participant Flow|Treatment Group|Knotless suture for wound closure
318995|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
318996|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
318997|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
318998|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
318999|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
319000|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
319001|NCT00834483|E2|Reported Event|Control Group|Layered traditional wound closure (monocryl)
319002|NCT00834483|E1|Reported Event|Treatment Group|Knotless suture for wound closure
319003|NCT00834444|B3|Baseline|Total|Total of all reporting groups
319004|NCT00834444|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
319005|NCT00834444|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
319006|NCT00834444|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
319007|NCT00834444|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
319008|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319009|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319010|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319011|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319012|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319013|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319014|NCT00834431|B3|Baseline|Total|Total of all reporting groups
319015|NCT00834431|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
319016|NCT00834431|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
319017|NCT00834431|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
319018|NCT00834431|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
319019|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319020|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319021|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319022|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319023|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
319024|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
319025|NCT00834418|B3|Baseline|Total|Total of all reporting groups
319026|NCT00834418|B2|Baseline|Arava™|Arava™ 20 mg Tablet
319027|NCT00834418|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
319028|NCT00834418|P2|Participant Flow|Arava™|Arava™ 20 mg Tablet
319029|NCT00834418|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
319030|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
319031|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
319032|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
319033|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
319044|NCT00834366|B2|Baseline|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319045|NCT00834366|B1|Baseline|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319046|NCT00834366|P2|Participant Flow|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319047|NCT00834366|P1|Participant Flow|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319048|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319049|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319050|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319051|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319052|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319053|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319054|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319055|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319056|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319057|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319058|NCT00834366|E2|Reported Event|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
319059|NCT00834366|E1|Reported Event|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
319060|NCT00834340|B3|Baseline|Total|Total of all reporting groups
319061|NCT00834340|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
319062|NCT00834340|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
319063|NCT00834340|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
319064|NCT00834340|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
319065|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
319066|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
319067|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
319068|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
319069|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
319070|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
319071|NCT00834288|B3|Baseline|Total|Total of all reporting groups
319072|NCT00834288|B2|Baseline|Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First|1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
319073|NCT00834288|B1|Baseline|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
319074|NCT00834288|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
319075|NCT00834288|P1|Participant Flow|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
319100|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
319101|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
319076|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319077|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319078|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319079|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319080|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319081|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319082|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319083|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319084|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319085|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319086|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319087|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319088|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319089|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319090|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319091|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319092|NCT00834288|E2|Reported Event|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
319093|NCT00834288|E1|Reported Event|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
319094|NCT00834275|B3|Baseline|Total|Total of all reporting groups
319095|NCT00834275|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
319096|NCT00834275|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
319097|NCT00834275|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
319098|NCT00834275|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
319099|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
323407|NCT00822354|O2|Outcome|Week 4 of Treatment|
319102|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
319103|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
319104|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
319105|NCT00834249|B3|Baseline|Total|Total of all reporting groups
319106|NCT00834249|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
319107|NCT00834249|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
319108|NCT00834249|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
319109|NCT00834249|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
319110|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319111|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319112|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319113|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319114|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319115|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319116|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319117|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319118|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319119|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319120|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
319121|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
319122|NCT00834236|B3|Baseline|Total|Total of all reporting groups
319123|NCT00834236|B2|Baseline|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319124|NCT00834236|B1|Baseline|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319125|NCT00834236|P2|Participant Flow|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319126|NCT00834236|P1|Participant Flow|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319127|NCT00834236|O2|Outcome|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319128|NCT00834236|O1|Outcome|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319129|NCT00834236|E2|Reported Event|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319130|NCT00834236|E1|Reported Event|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
319131|NCT00834210|B3|Baseline|Total|Total of all reporting groups
319132|NCT00834210|B2|Baseline|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319133|NCT00834210|B1|Baseline|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319134|NCT00834210|P2|Participant Flow|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319135|NCT00834210|P1|Participant Flow|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319136|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319137|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319138|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319139|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319140|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319141|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319142|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319143|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319144|NCT00834210|E2|Reported Event|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
319145|NCT00834210|E1|Reported Event|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
319146|NCT00834197|B3|Baseline|Total|Total of all reporting groups
319147|NCT00834197|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
319148|NCT00834197|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
319149|NCT00834197|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
319150|NCT00834197|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
319151|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
319152|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
319153|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
319154|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
319155|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
319156|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
319157|NCT00834171|B3|Baseline|Total|Total of all reporting groups
319158|NCT00834171|B2|Baseline|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
319159|NCT00834171|B1|Baseline|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
319160|NCT00834171|P2|Participant Flow|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
319161|NCT00834171|P1|Participant Flow|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
319162|NCT00834171|O2|Outcome|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
319163|NCT00834171|O1|Outcome|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
319164|NCT00834171|E2|Reported Event|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
319165|NCT00834171|E1|Reported Event|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
319166|NCT00834132|B3|Baseline|Total|Total of all reporting groups
319167|NCT00834132|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
319168|NCT00834132|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
319169|NCT00834132|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
319170|NCT00834132|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
319171|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
319172|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
319173|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
319174|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
319175|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
319176|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
319177|NCT00834080|B1|Baseline|VIVITROL, 380mg|
319178|NCT00834080|P1|Participant Flow|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
319179|NCT00834080|O1|Outcome|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
319180|NCT00834080|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
319181|NCT00834067|B3|Baseline|Total|Total of all reporting groups
319182|NCT00834067|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
319183|NCT00834067|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
319184|NCT00834067|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
319185|NCT00834067|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
319186|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319187|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319188|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319189|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319190|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319191|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319192|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319193|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319194|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319195|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319196|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319197|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319198|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319199|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
320096|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
319200|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319201|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319202|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
319203|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
319204|NCT00834041|B3|Baseline|Total|Total of all reporting groups
319205|NCT00834041|B2|Baseline|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319206|NCT00834041|B1|Baseline|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319207|NCT00834041|P2|Participant Flow|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319208|NCT00834041|P1|Participant Flow|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319209|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319210|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319211|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319212|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319213|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319214|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319215|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319216|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319217|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319218|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319219|NCT00834041|E2|Reported Event|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
319220|NCT00834041|E1|Reported Event|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
319221|NCT00833976|B1|Baseline|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
319222|NCT00833976|P1|Participant Flow|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
319223|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
319224|NCT00833976|E1|Reported Event|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
319225|NCT00833937|B3|Baseline|Total|Total of all reporting groups
319226|NCT00833937|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
319227|NCT00833937|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
319228|NCT00833937|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
319229|NCT00833937|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
319230|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319231|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319232|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319233|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319234|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319235|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319236|NCT00833924|B1|Baseline|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
319237|NCT00833924|P1|Participant Flow|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
319238|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
319239|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
319240|NCT00833924|E1|Reported Event|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
319241|NCT00833911|B1|Baseline|300 mg Tramadol HCl OAD|
319242|NCT00833911|P1|Participant Flow|300 mg Tramadol HCl OAD|
319243|NCT00833911|O3|Outcome|12-months Safety|
319244|NCT00833911|O2|Outcome|6-months Safety|
320097|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
319245|NCT00833911|O1|Outcome|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
319246|NCT00833911|E3|Reported Event|12-months Safety|
319247|NCT00833911|E2|Reported Event|6-months Safety|
319248|NCT00833911|E1|Reported Event|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
319249|NCT00833898|B3|Baseline|Total|Total of all reporting groups
319250|NCT00833898|B2|Baseline|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319251|NCT00833898|B1|Baseline|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319252|NCT00833898|P2|Participant Flow|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319253|NCT00833898|P1|Participant Flow|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319254|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319255|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319256|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319257|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319258|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319259|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319260|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319261|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319262|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319263|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319264|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319265|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319266|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319267|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319268|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319269|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319270|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319271|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319272|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319273|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319274|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319275|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319276|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319277|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319278|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319279|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319280|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319281|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319282|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319283|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319284|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319285|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319286|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319287|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319288|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319289|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319290|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319291|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319292|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319293|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319294|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319295|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319296|NCT00833898|E2|Reported Event|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
319297|NCT00833898|E1|Reported Event|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
319298|NCT00833859|B1|Baseline|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
319299|NCT00833859|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
319300|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
319301|NCT00833859|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
319302|NCT00833833|B7|Baseline|Total|Total of all reporting groups
319327|NCT00833833|O2|Outcome|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
319303|NCT00833833|B6|Baseline|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
319304|NCT00833833|B5|Baseline|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319305|NCT00833833|B4|Baseline|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319306|NCT00833833|B3|Baseline|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319307|NCT00833833|B2|Baseline|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319308|NCT00833833|B1|Baseline|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319309|NCT00833833|P6|Participant Flow|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
319310|NCT00833833|P5|Participant Flow|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319311|NCT00833833|P4|Participant Flow|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319312|NCT00833833|P3|Participant Flow|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319313|NCT00833833|P2|Participant Flow|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319314|NCT00833833|P1|Participant Flow|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319315|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
319316|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319317|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
319318|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319319|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
319320|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319321|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
319322|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319323|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
319324|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319325|NCT00833833|O4|Outcome|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
319326|NCT00833833|O3|Outcome|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
319328|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319329|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319330|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319331|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319332|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319333|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319334|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319335|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319336|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319337|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
319338|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319339|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319340|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319341|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319342|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319343|NCT00833833|E8|Reported Event|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
319344|NCT00833833|E7|Reported Event|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
319345|NCT00833833|E6|Reported Event|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
319346|NCT00833833|E5|Reported Event|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
319347|NCT00833833|E4|Reported Event|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319348|NCT00833833|E3|Reported Event|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319349|NCT00833833|E2|Reported Event|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319350|NCT00833833|E1|Reported Event|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
319351|NCT00833521|B3|Baseline|Total|Total of all reporting groups
319352|NCT00833521|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
319353|NCT00833521|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
319354|NCT00833521|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
319355|NCT00833521|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
319356|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319357|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319358|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319359|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319360|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
319361|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
319362|NCT00833482|B3|Baseline|Total|Total of all reporting groups
319363|NCT00833482|B2|Baseline|Poor Metabolizers (PM)|Participants without a functional CYP2C19 allele (poor metabolizers, or PM).
320098|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
319364|NCT00833482|B1|Baseline|Extensive Metabolizers (EM)|Participants with functional CYP2C19 alleles (extensive metabolizers, or EM).
319365|NCT00833482|P6|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319366|NCT00833482|P5|Participant Flow|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319367|NCT00833482|P4|Participant Flow|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319368|NCT00833482|P3|Participant Flow|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319369|NCT00833482|P2|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319370|NCT00833482|P1|Participant Flow|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319371|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319372|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319373|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319374|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319375|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319376|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319377|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319378|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319379|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319380|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319381|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319382|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319383|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319384|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319385|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319386|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319387|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319388|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319448|NCT00833417|B1|Baseline|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319389|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319390|NCT00833482|O5|Outcome|Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319391|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319392|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319393|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319394|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319395|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319396|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319397|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319398|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319399|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319400|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319401|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319402|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319403|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319404|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319405|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319406|NCT00833482|O1|Outcome|Voriconazole, 200 BID|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319407|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319408|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319409|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319410|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319411|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319651|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
320099|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
319412|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319413|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319414|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319415|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319416|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319417|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319418|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319419|NCT00833482|E6|Reported Event|Atazanazvir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
319420|NCT00833482|E5|Reported Event|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319421|NCT00833482|E4|Reported Event|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
319422|NCT00833482|E3|Reported Event|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
319423|NCT00833482|E2|Reported Event|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal
319424|NCT00833482|E1|Reported Event|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
319425|NCT00833469|B1|Baseline|Escitalopram|"Flexible dose escitalopram 10mg~Escitalopram: Once daily by mouth"
319426|NCT00833469|P1|Participant Flow|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
319427|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
319428|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
319429|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
319430|NCT00833469|E1|Reported Event|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
319431|NCT00833443|B3|Baseline|Total|Total of all reporting groups
319432|NCT00833443|B2|Baseline|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319433|NCT00833443|B1|Baseline|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319434|NCT00833443|P2|Participant Flow|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319449|NCT00833417|P2|Participant Flow|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
320100|NCT00831129|E2|Reported Event|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
319435|NCT00833443|P1|Participant Flow|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319436|NCT00833443|O2|Outcome|NOT Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication NON-adherence
319437|NCT00833443|O1|Outcome|Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication adherence
319438|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319439|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319440|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319441|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319442|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319443|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319444|NCT00833443|E2|Reported Event|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
319445|NCT00833443|E1|Reported Event|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
319446|NCT00833417|B3|Baseline|Total|Total of all reporting groups
319447|NCT00833417|B2|Baseline|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319652|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
319450|NCT00833417|P1|Participant Flow|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319451|NCT00833417|O1|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319452|NCT00833417|O1|Outcome|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319453|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319454|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319455|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319456|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319457|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319458|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319459|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319460|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319461|NCT00833417|E1|Reported Event|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
319462|NCT00833365|B3|Baseline|Total|Total of all reporting groups
319463|NCT00833365|B2|Baseline|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
319464|NCT00833365|B1|Baseline|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
319465|NCT00833365|P2|Participant Flow|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
319466|NCT00833365|P1|Participant Flow|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
319467|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
319468|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
319469|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
319470|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
319471|NCT00833365|E2|Reported Event|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
319472|NCT00833365|E1|Reported Event|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
319473|NCT00833248|B3|Baseline|Total|Total of all reporting groups
319474|NCT00833248|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319475|NCT00833248|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319493|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319476|NCT00833248|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319477|NCT00833248|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319478|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319479|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319480|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319481|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319482|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319483|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319484|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319485|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319486|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319487|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319488|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319489|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319490|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319491|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319492|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319635|NCT00832520|P1|Participant Flow|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
319636|NCT00832520|O1|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
319494|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319495|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319496|NCT00833248|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
319497|NCT00833248|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
319498|NCT00833092|B3|Baseline|Total|Total of all reporting groups
319499|NCT00833092|B2|Baseline|Magnesium|300 milligrams of magnesium daily
319500|NCT00833092|B1|Baseline|Sugar Pill|zero magnesium supplementation
319501|NCT00833092|P2|Participant Flow|Magnesium|300 milligrams of magnesium daily
319502|NCT00833092|P1|Participant Flow|Sugar Pill|zero magnesium supplementation
319503|NCT00833092|O2|Outcome|Magnesium|300 milligrams of magnesium daily
319504|NCT00833092|O1|Outcome|Sugar Pill|zero magnesium supplementation
319505|NCT00833092|E2|Reported Event|Magnesium|300 milligrams of magnesium daily
319506|NCT00833092|E1|Reported Event|Sugar Pill|zero magnesium supplementation
319507|NCT00833053|B3|Baseline|Total|Total of all reporting groups
319508|NCT00833053|B2|Baseline|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319509|NCT00833053|B1|Baseline|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319510|NCT00833053|P2|Participant Flow|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319511|NCT00833053|P1|Participant Flow|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319512|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319513|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319514|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319515|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319516|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319517|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319518|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319519|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319520|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319521|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319522|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319523|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319524|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319525|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319526|NCT00833053|E2|Reported Event|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
319527|NCT00833053|E1|Reported Event|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
319528|NCT00833040|B1|Baseline|Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.~During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain."
319529|NCT00833040|P6|Participant Flow|Sequence 6|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319530|NCT00833040|P5|Participant Flow|Sequence 5|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319637|NCT00832520|E1|Reported Event|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
319638|NCT00832455|B1|Baseline|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
319639|NCT00832455|P1|Participant Flow|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
319531|NCT00833040|P4|Participant Flow|Sequence 4|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319532|NCT00833040|P3|Participant Flow|Sequence 3|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319533|NCT00833040|P2|Participant Flow|Sequence 2|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319534|NCT00833040|P1|Participant Flow|Sequence 1|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
319535|NCT00833040|O2|Outcome|Double Blind Phase of 3 Pbo Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
319536|NCT00833040|O1|Outcome|Double Blind Phase of 7 Sufentanil Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
319537|NCT00833040|E1|Reported Event|Titration of Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.~During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain."
319538|NCT00833027|B1|Baseline|Sitagliptin 100mg|
319539|NCT00833027|P1|Participant Flow|Sitagliptin 100mg|
319540|NCT00833027|O1|Outcome|Sitagliptin 100mg|
319541|NCT00833027|O1|Outcome|Sitagliptin 100mg|
319542|NCT00833027|E1|Reported Event|Sitagliptin 100mg|
319543|NCT00832975|B1|Baseline|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
319544|NCT00832975|P1|Participant Flow|St Jude Medical ICD/CRT-D|St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
319545|NCT00832975|O1|Outcome|Single Arm|St Jude Medical ICD/CRT-D Device implanted patients
319546|NCT00832975|O1|Outcome|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
319547|NCT00832975|E1|Reported Event|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
319548|NCT00832871|B1|Baseline|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319549|NCT00832871|P1|Participant Flow|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319550|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319551|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319552|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319553|NCT00832871|E1|Reported Event|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
319554|NCT00832819|B4|Baseline|Total|Total of all reporting groups
319555|NCT00832819|B3|Baseline|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319556|NCT00832819|B2|Baseline|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319557|NCT00832819|B1|Baseline|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319640|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|
319641|NCT00832455|O2|Outcome|Montelukast ITT at Week 8|
319642|NCT00832455|O1|Outcome|Montelukast ITT at Week 4|
319558|NCT00832819|P3|Participant Flow|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319559|NCT00832819|P2|Participant Flow|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319560|NCT00832819|P1|Participant Flow|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319561|NCT00832819|O1|Outcome|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319562|NCT00832819|E3|Reported Event|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319563|NCT00832819|E2|Reported Event|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319564|NCT00832819|E1|Reported Event|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
319565|NCT00832650|B4|Baseline|Total|Total of all reporting groups
319566|NCT00832650|B3|Baseline|Solifenacin|Solifenacin 10 mg capsule once daily
319567|NCT00832650|B2|Baseline|Placebo|Matched placebo tablet or capsule
319568|NCT00832650|B1|Baseline|Fesoterodine|Fesoterodine 8 mg tablet once daily
319569|NCT00832650|P3|Participant Flow|Solifenacin|Solifenacin 10 mg capsule once daily
319570|NCT00832650|P2|Participant Flow|Placebo|Matched placebo tablet or capsule
319571|NCT00832650|P1|Participant Flow|Fesoterodine|Fesoterodine 8 mg tablet once daily
319572|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319573|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319574|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319575|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319576|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319577|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319578|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319579|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319580|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319581|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319582|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319583|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319584|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319585|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319586|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319587|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319588|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319589|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319590|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319591|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319592|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319593|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319594|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319595|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319596|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
319597|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
319598|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
319599|NCT00832650|E3|Reported Event|Solifenacin|Solifenacin 10 mg capsule once daily
319600|NCT00832650|E2|Reported Event|Placebo|Matched placebo tablet or capsule
319601|NCT00832650|E1|Reported Event|Fesoterodine|Fesoterodine 8 mg tablet once daily
319602|NCT00832637|B1|Baseline|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319603|NCT00832637|P1|Participant Flow|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319604|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319605|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319606|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319607|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319608|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319609|NCT00832637|E1|Reported Event|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
319610|NCT00832624|B1|Baseline|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
319611|NCT00832624|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
319612|NCT00832624|O1|Outcome|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
319613|NCT00832624|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
319614|NCT00832585|B1|Baseline|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
319615|NCT00832585|P1|Participant Flow|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
319616|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
319617|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
319618|NCT00832585|E1|Reported Event|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
319619|NCT00832572|B3|Baseline|Total|Total of all reporting groups
319620|NCT00832572|B2|Baseline|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
319621|NCT00832572|B1|Baseline|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
319622|NCT00832572|P2|Participant Flow|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
319623|NCT00832572|P1|Participant Flow|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
319624|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
319625|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
319626|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
319627|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
319628|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
319629|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
319630|NCT00832572|E4|Reported Event|Ranolazine/Placebo, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
319631|NCT00832572|E3|Reported Event|Ranolazine/Placebo, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
319632|NCT00832572|E2|Reported Event|Placebo/Ranolazine, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
319633|NCT00832572|E1|Reported Event|Placebo/Ranolazine, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
319634|NCT00832520|B1|Baseline|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
319653|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
319654|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
319655|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
319656|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
319657|NCT00832455|E1|Reported Event|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
319658|NCT00832416|B5|Baseline|Total|Total of all reporting groups
319659|NCT00832416|B4|Baseline|4: Placebo|
319660|NCT00832416|B3|Baseline|3: Tramadol Once A Day 300mg|
319661|NCT00832416|B2|Baseline|2: Tramadol Once A Day 200mg|
319662|NCT00832416|B1|Baseline|1: Tramadol Once A Day 100mg|
319663|NCT00832416|P4|Participant Flow|4: Placebo|
319664|NCT00832416|P3|Participant Flow|3: Tramadol Once A Day 300mg|
319665|NCT00832416|P2|Participant Flow|2: Tramadol Once A Day 200mg|
319666|NCT00832416|P1|Participant Flow|1: Tramadol Once A Day 100mg|
319667|NCT00832416|O4|Outcome|4: Placebo|
319668|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319669|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319670|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319671|NCT00832416|O4|Outcome|4: Placebo|
319672|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319673|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319674|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319675|NCT00832416|O4|Outcome|4: Placebo|
319676|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319677|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319678|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319679|NCT00832416|O4|Outcome|4: Placebo|
319680|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319681|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319682|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319683|NCT00832416|O4|Outcome|4: Placebo|
319684|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319685|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319686|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319687|NCT00832416|O4|Outcome|4: Placebo|
319688|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319689|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319690|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319691|NCT00832416|O4|Outcome|4: Placebo|
319692|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319693|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319694|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319695|NCT00832416|O4|Outcome|4: Placebo|
319696|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
319697|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
319698|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
319699|NCT00832416|E4|Reported Event|4: Placebo|
319700|NCT00832416|E3|Reported Event|3: Tramadol Once A Day 300mg|
319701|NCT00832416|E2|Reported Event|2: Tramadol Once A Day 200mg|
319702|NCT00832416|E1|Reported Event|1: Tramadol Once A Day 100mg|
319703|NCT00832390|B4|Baseline|Total|Total of all reporting groups
319704|NCT00832390|B3|Baseline|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
319705|NCT00832390|B2|Baseline|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
319706|NCT00832390|B1|Baseline|Sitagliptin 100 mg q.d. (Once Daily)|
319707|NCT00832390|P3|Participant Flow|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
319708|NCT00832390|P2|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
319709|NCT00832390|P1|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily)|
319710|NCT00832390|O3|Outcome|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
319711|NCT00832390|O2|Outcome|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
319712|NCT00832390|O1|Outcome|Sitagliptin 100 mg q.d. (Once Daily)|
319713|NCT00832390|E3|Reported Event|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
319714|NCT00832390|E2|Reported Event|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
319715|NCT00832390|E1|Reported Event|Sitagliptin 100 mg q.d. (Once Daily)|
319716|NCT00832377|B1|Baseline|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319717|NCT00832377|P1|Participant Flow|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319718|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319719|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319720|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319721|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319722|NCT00832377|E1|Reported Event|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
319723|NCT00832299|B1|Baseline|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
319841|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319724|NCT00832299|P1|Participant Flow|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
319725|NCT00832299|O1|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
319726|NCT00832299|E1|Reported Event|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
319727|NCT00832260|B1|Baseline|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
319728|NCT00832260|P1|Participant Flow|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
319729|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
319730|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
319731|NCT00832260|E1|Reported Event|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
319732|NCT00832130|B3|Baseline|Total|Total of all reporting groups
319733|NCT00832130|B2|Baseline|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319734|NCT00832130|B1|Baseline|Manual Mini System|Treatment with experimental Manual Mini System
319735|NCT00832130|P2|Participant Flow|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319736|NCT00832130|P1|Participant Flow|Manual Mini System|Treatment with experimental Manual Mini System
319737|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319738|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319739|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319740|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319741|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319742|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319743|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319744|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319745|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319746|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319747|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319748|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319749|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319750|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319751|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319752|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
319753|NCT00832130|E2|Reported Event|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
319754|NCT00832130|E1|Reported Event|Manual Mini System|Treatment with experimental Manual Mini System
319755|NCT00832117|B3|Baseline|Total|Total of all reporting groups
319756|NCT00832117|B2|Baseline|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319757|NCT00832117|B1|Baseline|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319758|NCT00832117|P1|Participant Flow|All Enrolled Participants|Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.
319759|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319760|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319761|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319762|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319763|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319764|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319765|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319766|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319767|NCT00832117|O1|Outcome|All Treated Participants|All participants who received at least 1 dose of either ixabepilone or carboplatin
319768|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319769|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319770|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319771|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319772|NCT00832117|E2|Reported Event|Ixa 32 mg/m2 +Cis 80 mg/m2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
319773|NCT00832117|E1|Reported Event|Ixa 32 mg/m2 + Cis 60 mg/m2|6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
319774|NCT00832091|B3|Baseline|Total|Total of all reporting groups
319775|NCT00832091|B2|Baseline|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
319776|NCT00832091|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
319777|NCT00832091|P2|Participant Flow|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
319778|NCT00832091|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
319779|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
319780|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
319781|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
319782|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
319783|NCT00832091|E2|Reported Event|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
319784|NCT00832091|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
319785|NCT00832078|B1|Baseline|Entire Study Population|
319786|NCT00832078|P2|Participant Flow|Group B|Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
319787|NCT00832078|P1|Participant Flow|Group A|Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
319788|NCT00832078|O2|Outcome|Standard Catheter SC|The Stanard catheter SpeediCath (SC)
319789|NCT00832078|O1|Outcome|Test Catheter SCCM|The Test catheter SpeediCath Compact Male (SCCM)
319790|NCT00832078|E2|Reported Event|Standard Catheter|
319791|NCT00832078|E1|Reported Event|Test Catheter|
319792|NCT00832000|B1|Baseline|All Study Participants|All participants received all inerventions; therefore, we combined all participants into one Arm/Group.
319793|NCT00832000|P2|Participant Flow|Placebo Then Mexiletine|"30 Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.~Included in analysis* 29 patients~*Modified intention to treat analysis. 1 subject in each not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period."
319794|NCT00832000|P1|Participant Flow|Mexiletine Then Placebo|"29 Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.~Included in anaysis*: 28 patients~*Modified intention to treat analysis. 1 subject in each group not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period"
319795|NCT00832000|O4|Outcome|Placebo - Period 2|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319796|NCT00832000|O3|Outcome|Mexiletine - Period 2|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319797|NCT00832000|O2|Outcome|Placebo - Period 1|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319798|NCT00832000|O1|Outcome|Mexiletine - Period 1|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319799|NCT00832000|O2|Outcome|Placebo|SF-36 physical composite score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
319800|NCT00832000|O1|Outcome|Mexiletine|SF-36 physical composite score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319801|NCT00832000|O2|Outcome|Placebo|INQoL summary score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
319802|NCT00832000|O1|Outcome|Mexiletine|INQoL summary score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319803|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude ( as a percentage of baseline measurement) for participants receiving placebo capsules orally three times daily either in period 1 or period 2
319804|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percentage of baseline measreument) for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319805|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
319806|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right TA for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319807|NCT00832000|O2|Outcome|Placebo|Average time to open eyes after forced eye closure for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
319808|NCT00832000|O1|Outcome|Mexiletine|Average time to open eyes after forced eye closure for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
319809|NCT00832000|O2|Outcome|Placebo|Average time to open the fist after forced hand grip for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
319810|NCT00832000|O1|Outcome|Mexiletine|Average time to open the fist after forced hand grip for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
319811|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
319812|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right ADM for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319813|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude (as a percento f baseline measurement) for particpants receiving mexiletine capsules orally three times daily either in period 1 or period 2
319814|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percent of baseline measurement) for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
319815|NCT00832000|O2|Outcome|Placebo|Average 90% to 5% hand grip relaxation time for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
319816|NCT00832000|O1|Outcome|Mexiletine|Average 90% to 5% hand grip relaxation time for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
319817|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced tiredness on placebo capsules orally three times daily in either period 1 or period 2.
319818|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced tiredness on mexiletine 200 mg capsules orally three times daily in either period 1 or period 2.
319819|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced weakness on placebo capsules orally three times daily in either period 1 or period 2.
319820|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced weakness on mexiletine capsules 200 mg orally three times daily in either period 1 or period 2.
319821|NCT00832000|O2|Outcome|Placebo|Participants experiencing pain on placebo capsules orally three times dailyin period 1 or period 2
319822|NCT00832000|O1|Outcome|Mexiletine|Participants experiencing pain on mexiletine capsules 200 mg orally three times daily in period 1 or period 2
319823|NCT00832000|O4|Outcome|Placebo - Period 2|Placebo capsules orally three times dailyperiod 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319824|NCT00832000|O3|Outcome|Mexiletine - Period 2|Mexiletine capsules 200 mg orally three times daily period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319825|NCT00832000|O2|Outcome|Placebo - Period 1|Placebo capsules orally three times dailyperiod 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319826|NCT00832000|O1|Outcome|Mexiletine - Period 1|Mexiletine capsules 200 mg orally three times daily period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
319827|NCT00832000|E2|Reported Event|Placebo Treatment|Adverse events that occurred when patients were taking mexiletine.
319828|NCT00832000|E1|Reported Event|Mexiletine Treatment|Adverse events that occurred when patients were taking placebo.
319829|NCT00831987|B3|Baseline|Total|Total of all reporting groups
319830|NCT00831987|B2|Baseline|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319831|NCT00831987|B1|Baseline|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319832|NCT00831987|P2|Participant Flow|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319833|NCT00831987|P1|Participant Flow|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319834|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319835|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319836|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319837|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319838|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319839|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319840|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319842|NCT00831987|E2|Reported Event|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319843|NCT00831987|E1|Reported Event|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
319844|NCT00831844|B11|Baseline|Total|Total of all reporting groups
319845|NCT00831844|B10|Baseline|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319846|NCT00831844|B9|Baseline|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319847|NCT00831844|B8|Baseline|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319848|NCT00831844|B7|Baseline|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319849|NCT00831844|B6|Baseline|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319850|NCT00831844|B5|Baseline|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319851|NCT00831844|B4|Baseline|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319852|NCT00831844|B3|Baseline|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319853|NCT00831844|B2|Baseline|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319854|NCT00831844|B1|Baseline|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319855|NCT00831844|P10|Participant Flow|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319856|NCT00831844|P9|Participant Flow|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319857|NCT00831844|P8|Participant Flow|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319858|NCT00831844|P7|Participant Flow|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319859|NCT00831844|P6|Participant Flow|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319860|NCT00831844|P5|Participant Flow|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319861|NCT00831844|P4|Participant Flow|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
320101|NCT00831129|E1|Reported Event|Placebo|simvastatin 40 mg/day plus placebo
320102|NCT00830960|B7|Baseline|Total|Total of all reporting groups
319862|NCT00831844|P3|Participant Flow|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319863|NCT00831844|P2|Participant Flow|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319864|NCT00831844|P1|Participant Flow|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319865|NCT00831844|O10|Outcome|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319866|NCT00831844|O9|Outcome|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319867|NCT00831844|O8|Outcome|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319868|NCT00831844|O7|Outcome|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319869|NCT00831844|O6|Outcome|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319870|NCT00831844|O5|Outcome|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319871|NCT00831844|O4|Outcome|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319872|NCT00831844|O3|Outcome|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319873|NCT00831844|O2|Outcome|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319874|NCT00831844|O1|Outcome|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319875|NCT00831844|E10|Reported Event|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319876|NCT00831844|E9|Reported Event|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319877|NCT00831844|E8|Reported Event|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319878|NCT00831844|E7|Reported Event|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319879|NCT00831844|E6|Reported Event|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319939|NCT00831675|E2|Reported Event|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319880|NCT00831844|E5|Reported Event|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319881|NCT00831844|E4|Reported Event|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319882|NCT00831844|E3|Reported Event|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319883|NCT00831844|E2|Reported Event|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319884|NCT00831844|E1|Reported Event|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
319885|NCT00831766|B3|Baseline|Total|Total of all reporting groups
319886|NCT00831766|B2|Baseline|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
319887|NCT00831766|B1|Baseline|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
319888|NCT00831766|P2|Participant Flow|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
319889|NCT00831766|P1|Participant Flow|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
319890|NCT00831766|O1|Outcome|All Participants Treated at MTD|All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
319891|NCT00831766|O1|Outcome|Phase I Participants|Dose escalation group.
319892|NCT00831766|E2|Reported Event|Phase II: Treatment at MTD|Participants enrolled during Phase II.
319893|NCT00831766|E1|Reported Event|Phase I: Dose Escalation|Participants enrolled during Phase I.
319894|NCT00831753|B3|Baseline|Total|Total of all reporting groups
319895|NCT00831753|B2|Baseline|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319896|NCT00831753|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319897|NCT00831753|P2|Participant Flow|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319898|NCT00831753|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319899|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319900|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319901|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
320030|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
319902|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319903|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319904|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319905|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319906|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319907|NCT00831753|E2|Reported Event|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
319908|NCT00831753|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
319909|NCT00831701|B3|Baseline|Total|Total of all reporting groups
319910|NCT00831701|B2|Baseline|Placebo Treatment|Patients received Placebo pill once daily
319911|NCT00831701|B1|Baseline|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319912|NCT00831701|P2|Participant Flow|Placebo Treatment|Patients received Placebo pill once daily
319913|NCT00831701|P1|Participant Flow|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319914|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
319915|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319916|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
319917|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319918|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
319919|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319920|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
319921|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319922|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
319923|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319924|NCT00831701|E2|Reported Event|Placebo Treatment|Patients received Placebo pill once daily
319925|NCT00831701|E1|Reported Event|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
319926|NCT00831675|B3|Baseline|Total|Total of all reporting groups
319927|NCT00831675|B2|Baseline|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319928|NCT00831675|B1|Baseline|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319929|NCT00831675|P2|Participant Flow|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319930|NCT00831675|P1|Participant Flow|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319931|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319932|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319933|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319934|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319935|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319936|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319937|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319938|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
320031|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
319940|NCT00831675|E1|Reported Event|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
319941|NCT00831493|B1|Baseline|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
319942|NCT00831493|P1|Participant Flow|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
319943|NCT00831493|O1|Outcome|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
319944|NCT00831493|E1|Reported Event|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
319945|NCT00831480|B1|Baseline|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
319946|NCT00831480|P1|Participant Flow|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
319947|NCT00831480|O1|Outcome|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
319948|NCT00831480|E1|Reported Event|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
319949|NCT00831441|B3|Baseline|Total|Total of all reporting groups
319950|NCT00831441|B2|Baseline|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily.
319951|NCT00831441|B1|Baseline|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319952|NCT00831441|P2|Participant Flow|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
319953|NCT00831441|P1|Participant Flow|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
319954|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319955|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319956|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319957|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319958|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319959|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319960|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319961|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319962|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319963|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319964|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319965|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319966|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319967|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319968|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319969|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319970|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319971|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319972|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319973|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319974|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
319975|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319976|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated in Year 2.
319977|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
319978|NCT00831441|E2|Reported Event|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
320095|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
319979|NCT00831441|E1|Reported Event|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
319980|NCT00831428|B1|Baseline|Scottish Swimming Team|
319981|NCT00831428|P1|Participant Flow|Scottish Swimming Team|
319982|NCT00831428|O1|Outcome|Scottish Swimming Team|
319983|NCT00831428|E1|Reported Event|Scottish Swimming Team|
319984|NCT00831415|B1|Baseline|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319985|NCT00831415|P1|Participant Flow|DVS SR|Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
319986|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319987|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319988|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319989|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319990|NCT00831415|E1|Reported Event|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
319991|NCT00831389|B1|Baseline|All Study Participants|Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.
319992|NCT00831389|P1|Participant Flow|All Participants|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319993|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319994|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319995|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319996|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319997|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319998|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
319999|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320000|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320001|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320002|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320003|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320004|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320005|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320006|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320007|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320008|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320009|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320010|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320011|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320012|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320013|NCT00831389|E2|Reported Event|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320014|NCT00831389|E1|Reported Event|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
320015|NCT00831311|B3|Baseline|Total|Total of all reporting groups
320016|NCT00831311|B2|Baseline|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320017|NCT00831311|B1|Baseline|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320018|NCT00831311|P2|Participant Flow|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320019|NCT00831311|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320020|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320021|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320022|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320023|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320024|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320025|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320026|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320027|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320028|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320029|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
323408|NCT00822354|O1|Outcome|Pre-treatment|
320032|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320033|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320034|NCT00831311|E2|Reported Event|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
320035|NCT00831311|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
320036|NCT00831233|B3|Baseline|Total|Total of all reporting groups
320037|NCT00831233|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320038|NCT00831233|B1|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320039|NCT00831233|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320040|NCT00831233|P1|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320041|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320042|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320043|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320044|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320045|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320046|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320047|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320048|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320049|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320050|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320051|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320052|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320053|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320054|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320055|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320056|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320057|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320058|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320059|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320060|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320061|NCT00831233|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
320062|NCT00831233|E1|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
320063|NCT00831129|B3|Baseline|Total|Total of all reporting groups
320064|NCT00831129|B2|Baseline|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320065|NCT00831129|B1|Baseline|Placebo|simvastatin 40 mg/day plus placebo
320066|NCT00831129|P2|Participant Flow|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320067|NCT00831129|P1|Participant Flow|Placebo|simvastatin 40 mg/day plus placebo
320068|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320069|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320070|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320071|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320072|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320073|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320074|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320075|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320076|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320077|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320078|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320079|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320080|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320081|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320082|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320083|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320084|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320085|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320086|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320087|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320088|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320089|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320090|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320091|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320092|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320093|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
320094|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
320103|NCT00830960|B6|Baseline|Clopidogrel 300/75 Low Weight/Elderly|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320104|NCT00830960|B5|Baseline|Prasugrel 30/5 Low Weight/Elderly|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320105|NCT00830960|B4|Baseline|Clopidogrel 300/75 Primary|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320106|NCT00830960|B3|Baseline|Prasugrel 30/5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320107|NCT00830960|B2|Baseline|Prasugrel 30/7.5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320108|NCT00830960|B1|Baseline|Prasugrel 60/10 Primary|"Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)~Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug."
320109|NCT00830960|P6|Participant Flow|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320110|NCT00830960|P5|Participant Flow|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320111|NCT00830960|P4|Participant Flow|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320112|NCT00830960|P3|Participant Flow|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320113|NCT00830960|P2|Participant Flow|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320114|NCT00830960|P1|Participant Flow|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320115|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320116|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320117|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320118|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320119|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320120|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320121|NCT00830960|O4|Outcome|Clopidogrel 300/75 PD|Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
320122|NCT00830960|O3|Outcome|Prasugrel 30/5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
320123|NCT00830960|O2|Outcome|Prasugrel 30/7.5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
320124|NCT00830960|O1|Outcome|Prasugrel 60/10 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.
320125|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320126|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320127|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320128|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320129|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320130|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320405|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
320131|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320132|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320133|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320134|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320135|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320136|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320137|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320138|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320139|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320140|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320141|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320142|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320143|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320144|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320145|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320146|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320147|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320148|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320149|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320150|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320151|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320152|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320153|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320154|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320155|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320156|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320157|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320158|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
321689|NCT00827073|E1|Reported Event|Tetracaine 0.5% Drop|"betadine: betadine 5%~Topical Anesthetic"
320159|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320160|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320161|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320162|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320163|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320164|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320165|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320166|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320167|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320168|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320169|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320170|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320171|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320172|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320173|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320174|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320175|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320176|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320177|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320178|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320179|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320180|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320181|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320182|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320183|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320184|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320185|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age <75 years)
320186|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
322506|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
320187|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320188|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320189|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320190|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320191|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320192|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320193|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320194|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320195|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320196|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
320197|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320198|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320199|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320200|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320201|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.
320202|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.
320203|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.
320204|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
320205|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.
320206|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320207|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
320208|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320209|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320210|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320211|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
320212|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
320213|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
320214|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
320215|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
320216|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
320406|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
320217|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
320218|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
320219|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
320220|NCT00830960|E7|Reported Event|Clopidogrel 300/75 No Weight|Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
320221|NCT00830960|E6|Reported Event|Clopidogrel 300/75 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
320222|NCT00830960|E5|Reported Event|Prasugrel 30/5 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
320223|NCT00830960|E4|Reported Event|Clopidogrel 300/75 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
320224|NCT00830960|E3|Reported Event|Prasugrel 30/5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
320225|NCT00830960|E2|Reported Event|Prasugrel 30/7.5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
320226|NCT00830960|E1|Reported Event|Prasugrel 60/10 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
320227|NCT00830947|B3|Baseline|Total|Total of all reporting groups
320228|NCT00830947|B2|Baseline|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
320229|NCT00830947|B1|Baseline|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
320230|NCT00830947|P2|Participant Flow|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
320231|NCT00830947|P1|Participant Flow|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
320232|NCT00830947|O2|Outcome|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
320233|NCT00830947|O1|Outcome|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
320234|NCT00830947|E2|Reported Event|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
320235|NCT00830947|E1|Reported Event|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
320236|NCT00830804|B1|Baseline|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320237|NCT00830804|P1|Participant Flow|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320238|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320239|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320240|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320241|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320242|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320243|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320244|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320245|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320246|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320247|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320248|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320249|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320250|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320251|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320252|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320253|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320254|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320255|NCT00830804|E1|Reported Event|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
320256|NCT00830791|B7|Baseline|Total|Total of all reporting groups
320257|NCT00830791|B6|Baseline|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
320258|NCT00830791|B5|Baseline|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
320259|NCT00830791|B4|Baseline|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320260|NCT00830791|B3|Baseline|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
320407|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
320261|NCT00830791|B2|Baseline|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320262|NCT00830791|B1|Baseline|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
320263|NCT00830791|P6|Participant Flow|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
320264|NCT00830791|P5|Participant Flow|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
320265|NCT00830791|P4|Participant Flow|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320266|NCT00830791|P3|Participant Flow|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
320267|NCT00830791|P2|Participant Flow|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320268|NCT00830791|P1|Participant Flow|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
320269|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg.
320270|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320271|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
320272|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320273|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
320274|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320275|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
320276|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320277|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
320278|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320279|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
320280|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320281|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose of 10 mg x 2.
320282|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320283|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320284|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320285|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320286|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320287|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
320288|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320289|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320290|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320291|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320292|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320293|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
320294|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320295|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320296|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320297|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320298|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320299|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
320300|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320301|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320302|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320303|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
320304|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
320305|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320306|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320307|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320308|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320309|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320310|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
320311|NCT00830791|E3|Reported Event|MK-0941 20 mg and Moderate Renal Insufficiency|MK-0941 was administered as a single oral dose of 20 mg to participants with moderate renal insufficiency.
320312|NCT00830791|E2|Reported Event|MK-0941 20 mg and Mild Renal Insufficiency|MK-0941 was administered as a single oral dose to participants with mild renal insufficiency.
320313|NCT00830791|E1|Reported Event|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
320314|NCT00830765|B3|Baseline|Total|Total of all reporting groups
320315|NCT00830765|B2|Baseline|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
320316|NCT00830765|B1|Baseline|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
320317|NCT00830765|P2|Participant Flow|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
320318|NCT00830765|P1|Participant Flow|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
320319|NCT00830765|O2|Outcome|Placebo Group|Progesterone injection was compared to placebo injection on a weekly basis.
320320|NCT00830765|O1|Outcome|Progesterone Group|Progesterone injection was compared to placebo injection on a weekly basis.
320321|NCT00830765|E2|Reported Event|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
320322|NCT00830765|E1|Reported Event|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
320323|NCT00830388|B1|Baseline|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
320324|NCT00830388|P1|Participant Flow|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
320325|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
320326|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
320327|NCT00830388|E1|Reported Event|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
320328|NCT00830375|B1|Baseline|Memantine|10-30mg tablets of memantine taken once daily by mouth
320329|NCT00830375|P1|Participant Flow|Memantine|10-30mg tablets of memantine taken once daily by mouth
320330|NCT00830375|O1|Outcome|Memantine|10-30mg tablets of memantine taken once daily by mouth
320331|NCT00830375|E1|Reported Event|Memantine|10-30mg tablets of memantine taken once daily by mouth
320332|NCT00830362|B3|Baseline|Total|Total of all reporting groups
320333|NCT00830362|B2|Baseline|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
320334|NCT00830362|B1|Baseline|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
320335|NCT00830362|P2|Participant Flow|Placebo|Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
323618|NCT00820612|B3|Baseline|Total|Total of all reporting groups
320336|NCT00830362|P1|Participant Flow|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
320337|NCT00830362|O2|Outcome|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
320338|NCT00830362|O1|Outcome|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
320339|NCT00830362|E2|Reported Event|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
320340|NCT00830362|E1|Reported Event|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
320341|NCT00830336|B3|Baseline|Total|Total of all reporting groups
320342|NCT00830336|B2|Baseline|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
320343|NCT00830336|B1|Baseline|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
320344|NCT00830336|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
320345|NCT00830336|P1|Participant Flow|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
320346|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
320347|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
320348|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
320349|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
320350|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
320351|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
320352|NCT00830310|B1|Baseline|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320353|NCT00830310|P1|Participant Flow|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320354|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320355|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320356|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
322507|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
320357|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320358|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320359|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320360|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320361|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320362|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320363|NCT00830310|E1|Reported Event|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
320364|NCT00830284|B1|Baseline|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
320365|NCT00830284|P1|Participant Flow|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
320366|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
320408|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
320409|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
323988|NCT00819637|O3|Outcome|Levalbuterol 3 Doses|
320367|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
320368|NCT00830284|E1|Reported Event|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
320369|NCT00830258|B3|Baseline|Total|Total of all reporting groups
320370|NCT00830258|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
320371|NCT00830258|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
320372|NCT00830258|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
320373|NCT00830258|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
320374|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320375|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320376|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320377|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320378|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320379|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320380|NCT00830232|B3|Baseline|Total|Total of all reporting groups
320381|NCT00830232|B2|Baseline|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320382|NCT00830232|B1|Baseline|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320383|NCT00830232|P2|Participant Flow|Open-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.~Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
320384|NCT00830232|P1|Participant Flow|Closed-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.~Carotid stenting was used on standard fashion using filters as embolic protection device."
320385|NCT00830232|O2|Outcome|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320386|NCT00830232|O1|Outcome|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320387|NCT00830232|E2|Reported Event|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320388|NCT00830232|E1|Reported Event|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
320389|NCT00830219|B3|Baseline|Total|Total of all reporting groups
320390|NCT00830219|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
320391|NCT00830219|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
320392|NCT00830219|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
320393|NCT00830219|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
320394|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320395|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320396|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320397|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320398|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320399|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320400|NCT00830206|B3|Baseline|Total|Total of all reporting groups
320401|NCT00830206|B2|Baseline|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
320402|NCT00830206|B1|Baseline|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
320403|NCT00830206|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
320404|NCT00830206|P1|Participant Flow|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
320410|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
320411|NCT00830167|B3|Baseline|Total|Total of all reporting groups
320412|NCT00830167|B2|Baseline|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320413|NCT00830167|B1|Baseline|Placebo|Placebo was administered twice a day for 15 weeks.
320414|NCT00830167|P2|Participant Flow|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320415|NCT00830167|P1|Participant Flow|Placebo|Placebo was administered twice a day for 15 weeks.
320416|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320417|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320418|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320419|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320420|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320421|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320422|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320423|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320424|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320425|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320426|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320427|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320428|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320429|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320430|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320431|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320432|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320433|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320434|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320435|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320436|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320437|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320465|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320523|NCT00830076|E1|Reported Event|Sitagliptin + Placebo Metformin|Participants received sitagliptin + placebo metformin for 2 days.
320438|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320439|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320440|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320441|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320442|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320443|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320444|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320445|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320446|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320447|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320448|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320449|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320450|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320451|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320452|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320453|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320454|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320455|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320456|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320457|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320458|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320459|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320460|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320461|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320462|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320463|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320464|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320524|NCT00830037|B3|Baseline|Total|Total of all reporting groups
320466|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320467|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320468|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320469|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320470|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320471|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320472|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320473|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320474|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320475|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320476|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320477|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320478|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320479|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320480|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320481|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
320482|NCT00830167|E2|Reported Event|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
320483|NCT00830167|E1|Reported Event|Placebo|Placebo was administered twice a day for 15 weeks.
320484|NCT00830128|B1|Baseline|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320485|NCT00830128|P1|Participant Flow|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320486|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320487|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320488|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320489|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320522|NCT00830076|E2|Reported Event|Metformin + Placebo Sitagliptin|Participants received metformin + placebo sitagliptin for 2 days.
322508|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
320490|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320491|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320492|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320493|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320494|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320495|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320496|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320497|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320498|NCT00830128|E1|Reported Event|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
320499|NCT00830115|B1|Baseline|Pantoprazole|All patients enrolled
320500|NCT00830115|P1|Participant Flow|Pantoprazole|All patients enrolled
320501|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320502|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320503|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320504|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320505|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320506|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320507|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320508|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320509|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320510|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320511|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320512|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320513|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
320514|NCT00830115|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320515|NCT00830076|B1|Baseline|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
320516|NCT00830076|P1|Participant Flow|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
320517|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
320518|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
320519|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
320520|NCT00830076|E4|Reported Event|Placebo Sitagliptin + Placebo Metformin|Participants received placebo sitagliptin + placebo metformin for 2 days.
320521|NCT00830076|E3|Reported Event|Sitagliptin + Metformin|Participants received co-administration of sitagliptin + metformin for 2 days.
320525|NCT00830037|B2|Baseline|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
320526|NCT00830037|B1|Baseline|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
320527|NCT00830037|P2|Participant Flow|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
320528|NCT00830037|P1|Participant Flow|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
320529|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
320530|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
320531|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
320532|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
320533|NCT00830037|E2|Reported Event|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
320534|NCT00830037|E1|Reported Event|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
320535|NCT00830024|B3|Baseline|Total|Total of all reporting groups
320536|NCT00830024|B2|Baseline|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
320537|NCT00830024|B1|Baseline|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
320538|NCT00830024|P2|Participant Flow|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
320539|NCT00830024|P1|Participant Flow|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
320540|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
320541|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
320542|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
320543|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
320544|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
320545|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
320546|NCT00829998|B3|Baseline|Total|Total of all reporting groups
320547|NCT00829998|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
320548|NCT00829998|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
320549|NCT00829998|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
320550|NCT00829998|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
320551|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320552|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320553|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320554|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320555|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320556|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320557|NCT00829985|B3|Baseline|Total|Total of all reporting groups
320558|NCT00829985|B2|Baseline|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320559|NCT00829985|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320560|NCT00829985|P2|Participant Flow|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320579|NCT00829933|P4|Participant Flow|Warfarin|"Warfarin potassium tablets:~Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose"
320561|NCT00829985|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320562|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320563|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320564|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320565|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320566|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320567|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320568|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320569|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320570|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320571|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320572|NCT00829985|E2|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
320573|NCT00829985|E1|Reported Event|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
320574|NCT00829933|B5|Baseline|Total|Total of all reporting groups
320575|NCT00829933|B4|Baseline|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
320576|NCT00829933|B3|Baseline|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
320577|NCT00829933|B2|Baseline|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
320578|NCT00829933|B1|Baseline|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
320580|NCT00829933|P3|Participant Flow|DU-176b High Dose 60mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
320581|NCT00829933|P2|Participant Flow|DU-176b Intermediate Dose 45mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
320582|NCT00829933|P1|Participant Flow|DU-176b Low Dose 30mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
320583|NCT00829933|O4|Outcome|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
320584|NCT00829933|O3|Outcome|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
320585|NCT00829933|O2|Outcome|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
320586|NCT00829933|O1|Outcome|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
320587|NCT00829933|E4|Reported Event|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
320588|NCT00829933|E3|Reported Event|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
320589|NCT00829933|E2|Reported Event|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
320590|NCT00829933|E1|Reported Event|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
320591|NCT00829868|B3|Baseline|Total|Total of all reporting groups
320592|NCT00829868|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
320593|NCT00829868|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
320594|NCT00829868|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
320595|NCT00829868|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
320596|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320597|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320598|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320599|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320600|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
320601|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
320602|NCT00829790|B3|Baseline|Total|Total of all reporting groups
320603|NCT00829790|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
320604|NCT00829790|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
320605|NCT00829790|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
320606|NCT00829790|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
320607|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320608|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320609|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320610|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320611|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320612|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320613|NCT00829764|B3|Baseline|Total|Total of all reporting groups
320614|NCT00829764|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
320615|NCT00829764|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
320616|NCT00829764|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
320617|NCT00829764|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
320618|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320619|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320620|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320621|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320622|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
320623|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
320624|NCT00829738|B1|Baseline|Pantoprazole|All patients enrolled
320625|NCT00829738|P1|Participant Flow|Pantoprazole|All patients enrolled
320626|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320627|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320628|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320629|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320630|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320631|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320632|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320633|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320634|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320635|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320636|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320637|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320638|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
320639|NCT00829738|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
320640|NCT00829712|B3|Baseline|Total|Total of all reporting groups
320641|NCT00829712|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
320642|NCT00829712|B1|Baseline|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
320643|NCT00829712|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
320644|NCT00829712|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
320645|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320646|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
320647|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320648|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
320649|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320650|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
320651|NCT00829686|B3|Baseline|Total|Total of all reporting groups
320652|NCT00829686|B2|Baseline|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
320653|NCT00829686|B1|Baseline|No Intervention|No antibiotic
320654|NCT00829686|P2|Participant Flow|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
320655|NCT00829686|P1|Participant Flow|No Intervention|No antibiotic
320656|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
320657|NCT00829686|O1|Outcome|No Intervention|No antibiotic
320658|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
320659|NCT00829686|O1|Outcome|No Intervention|No antibiotic
320660|NCT00829673|B3|Baseline|Total|Total of all reporting groups
320661|NCT00829673|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
320662|NCT00829673|B1|Baseline|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
320663|NCT00829673|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
320664|NCT00829673|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
320665|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320666|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
320667|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320668|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
320669|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
320670|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
320671|NCT00829621|B3|Baseline|Total|Total of all reporting groups
320672|NCT00829621|B2|Baseline|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
320673|NCT00829621|B1|Baseline|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
320674|NCT00829621|P2|Participant Flow|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
320675|NCT00829621|P1|Participant Flow|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
320676|NCT00829621|O2|Outcome|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
320786|NCT00829283|B1|Baseline|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
320677|NCT00829621|O1|Outcome|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
320678|NCT00829621|E2|Reported Event|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
320679|NCT00829621|E1|Reported Event|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
320680|NCT00829530|B3|Baseline|Total|Total of all reporting groups
320681|NCT00829530|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
320682|NCT00829530|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
320683|NCT00829530|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
320684|NCT00829530|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
320685|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320686|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320687|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320688|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320689|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320690|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320691|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320692|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320693|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320694|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320695|NCT00829504|B3|Baseline|Total|Total of all reporting groups
320696|NCT00829504|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
320697|NCT00829504|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
320698|NCT00829504|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
320699|NCT00829504|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
320700|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320701|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320702|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320703|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320704|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
320705|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
320706|NCT00829452|B3|Baseline|Total|Total of all reporting groups
320707|NCT00829452|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
320708|NCT00829452|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
320709|NCT00829452|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
320710|NCT00829452|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
320711|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320712|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320713|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320714|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320715|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320716|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320717|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320718|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320719|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
320720|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
320747|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320785|NCT00829283|B2|Baseline|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
320721|NCT00829439|B1|Baseline|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
320722|NCT00829439|P4|Participant Flow|Levodopa / Carbidopa 15 mg/kg/Day|Levodopa / Carbidopa 15 mg/kg/day in 3 divided doses
320723|NCT00829439|P3|Participant Flow|Levodopa / Carbidopa 10 mg/kg/Day|Levodopa 10 mg/kg/day in 3 divided doses
320724|NCT00829439|P2|Participant Flow|Levodopa / Carbidopa 5 mg/kg/Day|Levodopa 5 mg/kg/day in 3 divided doses
320725|NCT00829439|P1|Participant Flow|Levodopa/Carbidopa 2 mg/kg/Day|Levodopa at 2 mg/kg/day in 3 divided doses
320726|NCT00829439|O1|Outcome|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
320727|NCT00829439|E1|Reported Event|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
320728|NCT00829426|B3|Baseline|Total|Total of all reporting groups
320729|NCT00829426|B2|Baseline|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
320730|NCT00829426|B1|Baseline|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
320731|NCT00829426|P2|Participant Flow|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
320732|NCT00829426|P1|Participant Flow|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
320733|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
320734|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
320735|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
320736|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
320737|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
320738|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
320739|NCT00829387|B3|Baseline|Total|Total of all reporting groups
320740|NCT00829387|B2|Baseline|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320741|NCT00829387|B1|Baseline|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320742|NCT00829387|P2|Participant Flow|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320743|NCT00829387|P1|Participant Flow|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320744|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320745|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320746|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320784|NCT00829283|B3|Baseline|Total|Total of all reporting groups
322509|NCT00824382|O1|Outcome|Placebo|Placebo
320748|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320749|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320750|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320751|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320752|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320753|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320754|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320755|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320756|NCT00829387|E2|Reported Event|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
320757|NCT00829387|E1|Reported Event|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
320758|NCT00829309|B3|Baseline|Total|Total of all reporting groups
320759|NCT00829309|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
320760|NCT00829309|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
320761|NCT00829309|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
320762|NCT00829309|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
320763|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320764|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320765|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320766|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320767|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
320768|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
320769|NCT00829296|B3|Baseline|Total|Total of all reporting groups
320770|NCT00829296|B2|Baseline|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320771|NCT00829296|B1|Baseline|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320772|NCT00829296|P2|Participant Flow|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320773|NCT00829296|P1|Participant Flow|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320774|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320775|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320776|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320777|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320778|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320779|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320780|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320781|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320782|NCT00829296|E2|Reported Event|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
320783|NCT00829296|E1|Reported Event|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
320787|NCT00829283|P2|Participant Flow|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
320788|NCT00829283|P1|Participant Flow|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
320789|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
320790|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
320791|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
320792|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
320793|NCT00829283|E2|Reported Event|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
320794|NCT00829283|E1|Reported Event|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
320795|NCT00829244|B3|Baseline|Total|Total of all reporting groups
320796|NCT00829244|B2|Baseline|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
320797|NCT00829244|B1|Baseline|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320798|NCT00829244|P2|Participant Flow|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
320799|NCT00829244|P1|Participant Flow|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320800|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320801|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320802|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320803|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320804|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320805|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320806|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320807|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320808|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320809|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320810|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320811|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320812|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320813|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320814|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320815|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320816|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320817|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320818|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320819|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320820|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320821|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320822|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320823|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320824|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
320825|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320826|NCT00829244|E2|Reported Event|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
320827|NCT00829244|E1|Reported Event|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
320828|NCT00829179|B1|Baseline|RhuMab-E25|
320829|NCT00829179|P1|Participant Flow|RhuMab-E25|"Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight.~Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg."
320830|NCT00829179|O1|Outcome|RhuMab-E25|
320831|NCT00829179|E1|Reported Event|RhuMab-E25|
320832|NCT00829166|B3|Baseline|Total|Total of all reporting groups
321083|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321690|NCT00826943|B1|Baseline|All Study Participants|Cross Over (all participants received all interventions)
320833|NCT00829166|B2|Baseline|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320834|NCT00829166|B1|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320835|NCT00829166|P2|Participant Flow|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320836|NCT00829166|P1|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
320837|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320838|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320839|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320840|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320841|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320842|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320843|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320844|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320845|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320846|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320847|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320848|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320849|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320850|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
322510|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
320851|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320852|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320853|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320854|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320855|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320856|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320857|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320858|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320859|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320860|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320861|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320862|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320863|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320864|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320865|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320866|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320867|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320868|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
321198|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320869|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320870|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320871|NCT00829166|E3|Reported Event|Lapatinib + Capecitabine/ Trastuzumab Emtansine|"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis."
320872|NCT00829166|E2|Reported Event|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
320873|NCT00829166|E1|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
320874|NCT00829049|B3|Baseline|Total|Total of all reporting groups
320875|NCT00829049|B2|Baseline|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320876|NCT00829049|B1|Baseline|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320877|NCT00829049|P2|Participant Flow|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320878|NCT00829049|P1|Participant Flow|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320879|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320880|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320881|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320882|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320883|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320884|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320885|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320886|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320887|NCT00829049|E2|Reported Event|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
320888|NCT00829049|E1|Reported Event|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
320889|NCT00829036|B1|Baseline|Baseline Wayfinding Performance|An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
320890|NCT00829036|P1|Participant Flow|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
320891|NCT00829036|O1|Outcome|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
320892|NCT00829036|E1|Reported Event|Wayfinding: Prototype vs. Baseline|"Prototype:~Subjects are trained to use the prototype to walk to selected destinations (1) in open spaces and (2) through hallways. Then, over 12 trials, subjects are asked to use the prototype to walk to a different unknown location in each trial. Half the locations are in open spaces and half in hallways. Performance time is measured.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subjects how to find (walk to) 12 specific locations, 6 in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations. Performance time is measured."
320893|NCT00829010|B6|Baseline|Total|Total of all reporting groups
321084|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321085|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321199|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320894|NCT00829010|B5|Baseline|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320895|NCT00829010|B4|Baseline|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320896|NCT00829010|B3|Baseline|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320897|NCT00829010|B2|Baseline|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320898|NCT00829010|B1|Baseline|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320899|NCT00829010|P5|Participant Flow|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320900|NCT00829010|P4|Participant Flow|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321086|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321087|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
320901|NCT00829010|P3|Participant Flow|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320902|NCT00829010|P2|Participant Flow|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320903|NCT00829010|P1|Participant Flow|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320904|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320905|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320906|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320907|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321088|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321200|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320908|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320909|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320910|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320911|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320912|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320913|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320914|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321089|NCT00828984|E3|Reported Event|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321090|NCT00828984|E2|Reported Event|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
320915|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320916|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320917|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320918|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320919|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320920|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320921|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321091|NCT00828984|E1|Reported Event|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321092|NCT00828945|B1|Baseline|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
323989|NCT00819637|O2|Outcome|Arformoterol 3 Doses|
320922|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320923|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320924|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320925|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320926|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320927|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320928|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321093|NCT00828945|P1|Participant Flow|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321094|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321201|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320929|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320930|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320931|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320932|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320933|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320934|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320935|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321095|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321096|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321097|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
320936|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320937|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320938|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320939|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320940|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320941|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320942|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321098|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321099|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321202|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320943|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320944|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320945|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320946|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320947|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320948|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320949|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321100|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321101|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321203|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320950|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320951|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320952|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320953|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320954|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320955|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320956|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321102|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321103|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321104|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
320957|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320958|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320959|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320960|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320961|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320962|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320963|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321105|NCT00828945|E1|Reported Event|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
321106|NCT00828841|B4|Baseline|Total|Total of all reporting groups
321190|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
320964|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320965|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320966|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320967|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320968|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320969|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320970|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321124|NCT00828750|B1|Baseline|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321191|NCT00828516|E1|Reported Event|Usual Care Plus Traditional Acupuncture|
323990|NCT00819637|O1|Outcome|Arformoterol 1 Dose, Placebo 2 Doses|
320971|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320972|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320973|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320974|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320975|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320976|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320977|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321125|NCT00828750|P1|Participant Flow|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
322511|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
320978|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320979|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320980|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320981|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320982|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320983|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320984|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321126|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321988|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
320985|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320986|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320987|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320988|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320989|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320990|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320991|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321127|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321192|NCT00828464|B1|Baseline|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
320992|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320993|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320994|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320995|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320996|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320997|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
320998|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321128|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321989|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
320999|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321000|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321001|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321002|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321003|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321004|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321005|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321129|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321193|NCT00828464|P1|Participant Flow|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321006|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321007|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321008|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321009|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321010|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321011|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321012|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321130|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321990|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
321013|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321014|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321015|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321016|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321017|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321018|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321019|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321131|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321991|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
321020|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321021|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321022|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321023|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321024|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321025|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321026|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321132|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321194|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321027|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321028|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321029|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321030|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321031|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321032|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321033|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321133|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321992|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
321034|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321035|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321036|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321037|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321038|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321039|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321040|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321134|NCT00828750|E1|Reported Event|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
321135|NCT00828711|B4|Baseline|Total|Total of all reporting groups
322512|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
321041|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321042|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321043|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321044|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321045|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321046|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321047|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321136|NCT00828711|B3|Baseline|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321195|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321048|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321049|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321050|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321051|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321052|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321053|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321054|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321137|NCT00828711|B2|Baseline|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321196|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321055|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321056|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321057|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321058|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321059|NCT00829010|E5|Reported Event|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321060|NCT00829010|E4|Reported Event|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321061|NCT00829010|E3|Reported Event|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321138|NCT00828711|B1|Baseline|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321197|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321062|NCT00829010|E2|Reported Event|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321063|NCT00829010|E1|Reported Event|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
321064|NCT00828984|B4|Baseline|Total|Total of all reporting groups
321065|NCT00828984|B3|Baseline|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321066|NCT00828984|B2|Baseline|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321067|NCT00828984|B1|Baseline|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321068|NCT00828984|P3|Participant Flow|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321069|NCT00828984|P2|Participant Flow|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321070|NCT00828984|P1|Participant Flow|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321071|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321072|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321073|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321074|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321075|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321076|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321077|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321078|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321079|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321080|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321081|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321082|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
321107|NCT00828841|B3|Baseline|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321108|NCT00828841|B2|Baseline|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321109|NCT00828841|B1|Baseline|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321110|NCT00828841|P3|Participant Flow|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321111|NCT00828841|P2|Participant Flow|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321112|NCT00828841|P1|Participant Flow|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321113|NCT00828841|O2|Outcome|Non-squamous Cell Histology|Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
321114|NCT00828841|O1|Outcome|Squamous Cell Histology|Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
321115|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321139|NCT00828711|P3|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
322513|NCT00824382|O1|Outcome|Placebo|Placebo
321116|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321117|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321118|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321119|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321120|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321121|NCT00828841|E3|Reported Event|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321122|NCT00828841|E2|Reported Event|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321123|NCT00828841|E1|Reported Event|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
321140|NCT00828711|P2|Participant Flow|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321141|NCT00828711|P1|Participant Flow|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321142|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321143|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321144|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321145|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321146|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321147|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321148|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321149|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321150|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321151|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321152|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321153|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321154|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321155|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321156|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321157|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321158|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321159|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321160|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321161|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321162|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321163|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321164|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321165|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321166|NCT00828711|E3|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321167|NCT00828711|E2|Reported Event|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321168|NCT00828711|E1|Reported Event|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
321169|NCT00828568|B4|Baseline|Total|Total of all reporting groups
321170|NCT00828568|B3|Baseline|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
321171|NCT00828568|B2|Baseline|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321172|NCT00828568|B1|Baseline|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321173|NCT00828568|P3|Participant Flow|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
321174|NCT00828568|P2|Participant Flow|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321175|NCT00828568|P1|Participant Flow|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321176|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
321177|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321178|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321179|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod vehicle for 16 weeks
321180|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321181|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321182|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321183|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321184|NCT00828568|E3|Reported Event|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
321185|NCT00828568|E2|Reported Event|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
321186|NCT00828568|E1|Reported Event|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
321187|NCT00828516|B1|Baseline|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
321188|NCT00828516|P1|Participant Flow|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
321189|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
321204|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321205|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321206|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321207|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321208|NCT00828464|E1|Reported Event|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
321209|NCT00828412|B3|Baseline|Total|Total of all reporting groups
321210|NCT00828412|B2|Baseline|Desonide Cream 0.05%|Desonide Cream 0.05%
321211|NCT00828412|B1|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
321212|NCT00828412|P2|Participant Flow|Desonide Cream 0.05%|Desonide Cream 0.05% topically twice daily
321213|NCT00828412|P1|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion topically twice daily
321214|NCT00828412|O2|Outcome|Desonide Cream 0.05%|Week 6 Desonide Cream 0.05%
321215|NCT00828412|O1|Outcome|EpiCeram Skin Barrier Emulsion|Week 6 EpiCeram Skin Barrier Emulsion
321216|NCT00828412|E2|Reported Event|Desonide Cream 0.05%|Desonide Cream 0.05%
321217|NCT00828412|E1|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
321218|NCT00828347|B3|Baseline|Total|Total of all reporting groups
321219|NCT00828347|B2|Baseline|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321220|NCT00828347|B1|Baseline|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321221|NCT00828347|P2|Participant Flow|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321222|NCT00828347|P1|Participant Flow|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321223|NCT00828347|O2|Outcome|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321224|NCT00828347|O1|Outcome|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321225|NCT00828347|E2|Reported Event|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321226|NCT00828347|E1|Reported Event|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
321227|NCT00828321|B3|Baseline|Total|Total of all reporting groups
321228|NCT00828321|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
321229|NCT00828321|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
321230|NCT00828321|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
321231|NCT00828321|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
321232|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
321233|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
321234|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
321235|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
321236|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
321237|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
321238|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
321239|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
321240|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
321241|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
321242|NCT00828308|B1|Baseline|Ixabepilone|Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
321243|NCT00828308|P1|Participant Flow|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
321244|NCT00828308|O1|Outcome|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
321245|NCT00828308|E1|Reported Event|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
321246|NCT00828295|B3|Baseline|Total|Total of all reporting groups
321247|NCT00828295|B2|Baseline|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
321248|NCT00828295|B1|Baseline|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
321249|NCT00828295|P2|Participant Flow|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
322514|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
321250|NCT00828295|P1|Participant Flow|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
321251|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
321252|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
321253|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
321254|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
321255|NCT00828295|E2|Reported Event|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
321256|NCT00828295|E1|Reported Event|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
321257|NCT00828204|B3|Baseline|Total|Total of all reporting groups
321258|NCT00828204|B2|Baseline|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321259|NCT00828204|B1|Baseline|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321260|NCT00828204|P2|Participant Flow|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321261|NCT00828204|P1|Participant Flow|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321262|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321263|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321264|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321265|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321321|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
321322|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
321993|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
321266|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321267|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321268|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321269|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321270|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321271|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321272|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321273|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321274|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321275|NCT00828204|E2|Reported Event|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
321323|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
321324|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
323991|NCT00819637|E3|Reported Event|Levalbuterol 3 Doses|
321276|NCT00828204|E1|Reported Event|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
321277|NCT00828191|B3|Baseline|Total|Total of all reporting groups
321278|NCT00828191|B2|Baseline|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321279|NCT00828191|B1|Baseline|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321280|NCT00828191|P2|Participant Flow|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321281|NCT00828191|P1|Participant Flow|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321282|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321283|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321284|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321285|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321286|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321287|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321288|NCT00828191|E2|Reported Event|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
321289|NCT00828191|E1|Reported Event|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
321290|NCT00828178|B3|Baseline|Total|Total of all reporting groups
321291|NCT00828178|B2|Baseline|Placebo|corn starch
321292|NCT00828178|B1|Baseline|Fish Oil|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
321293|NCT00828178|P2|Participant Flow|Placebo|Placebo (corn starch) once daily
321294|NCT00828178|P1|Participant Flow|Fish Oil|fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
321295|NCT00828178|O2|Outcome|Placebo|Corn Starch
321296|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
321297|NCT00828178|O2|Outcome|Placebo|Placebo (cornstarch)
321298|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
321299|NCT00828178|O2|Outcome|Placebo|Corn starch
321300|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
321301|NCT00828178|E2|Reported Event|Placebo|Placebo (cornstarch)
321302|NCT00828178|E1|Reported Event|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
321303|NCT00828139|B5|Baseline|Total|Total of all reporting groups
321304|NCT00828139|B4|Baseline|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
321305|NCT00828139|B3|Baseline|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
321306|NCT00828139|B2|Baseline|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
321307|NCT00828139|B1|Baseline|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
321308|NCT00828139|P4|Participant Flow|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
321309|NCT00828139|P3|Participant Flow|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
321310|NCT00828139|P2|Participant Flow|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
321311|NCT00828139|P1|Participant Flow|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
321312|NCT00828139|O2|Outcome|Topotecan|
321313|NCT00828139|O1|Outcome|Ziv-aflibercept + Topotecan|
321314|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
321315|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
321316|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
321317|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
321318|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
321319|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
321320|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
321370|NCT00827944|P1|Participant Flow|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321325|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
321326|NCT00828139|E2|Reported Event|Topotecan|There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
321327|NCT00828139|E1|Reported Event|Ziv-aflibercept + Topotecan|There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
321328|NCT00828113|B3|Baseline|Total|Total of all reporting groups
321329|NCT00828113|B2|Baseline|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
321330|NCT00828113|B1|Baseline|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
321331|NCT00828113|P2|Participant Flow|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
321332|NCT00828113|P1|Participant Flow|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
321333|NCT00828113|O2|Outcome|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
321334|NCT00828113|O1|Outcome|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
321335|NCT00828113|E2|Reported Event|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
321336|NCT00828113|E1|Reported Event|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
321337|NCT00828061|B1|Baseline|All Patients|All patients who completed at least one period are included in the analysis
321338|NCT00828061|P6|Participant Flow|Prednisone / Prednisone / Placebo|1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
321339|NCT00828061|P5|Participant Flow|Prednisone / Placebo / Prednisone|1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
321340|NCT00828061|P4|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
321341|NCT00828061|P3|Participant Flow|Prednisone / Placebo / Prednisone|1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
321342|NCT00828061|P2|Participant Flow|Prednisone / Prednisone / Placebo|1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
321343|NCT00828061|P1|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
321344|NCT00828061|O3|Outcome|25 mg Prednisone|
321345|NCT00828061|O2|Outcome|10 mg Prednisone|
321346|NCT00828061|O1|Outcome|Placebo|
321347|NCT00828061|O3|Outcome|25 mg Prednisone|
321348|NCT00828061|O2|Outcome|10 mg Prednisone|
321349|NCT00828061|O1|Outcome|Placebo|
321350|NCT00828061|E3|Reported Event|25 mg Prednisone|
321351|NCT00828061|E2|Reported Event|10 mg Prednisone|
321352|NCT00828061|E1|Reported Event|Placebo|
321353|NCT00827983|B3|Baseline|Total|Total of all reporting groups
321354|NCT00827983|B2|Baseline|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321355|NCT00827983|B1|Baseline|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321356|NCT00827983|P2|Participant Flow|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321357|NCT00827983|P1|Participant Flow|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321358|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321359|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321360|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321361|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321362|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321363|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321364|NCT00827983|E2|Reported Event|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321365|NCT00827983|E1|Reported Event|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
321366|NCT00827944|B3|Baseline|Total|Total of all reporting groups
321367|NCT00827944|B2|Baseline|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321368|NCT00827944|B1|Baseline|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321369|NCT00827944|P2|Participant Flow|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321994|NCT00825344|E2|Reported Event|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
321371|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321372|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321373|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321374|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321375|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321376|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321377|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321378|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321379|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321380|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321381|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321382|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321383|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321384|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321385|NCT00827944|E2|Reported Event|Lichtenstein Group|"Low weight polypropylene mesh~Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
321386|NCT00827944|E1|Reported Event|Progrip Group|"Parietex ProGrip~Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
321387|NCT00827931|B3|Baseline|Total|Total of all reporting groups
321388|NCT00827931|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321389|NCT00827931|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321390|NCT00827931|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321391|NCT00827931|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321392|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321393|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321394|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321395|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321396|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321397|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321398|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321399|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
323992|NCT00819637|E2|Reported Event|Arformoterol 3 Doses|
321400|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321401|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321402|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321403|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321404|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321405|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321406|NCT00827931|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
321407|NCT00827931|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
321408|NCT00827918|B4|Baseline|Total|Total of all reporting groups
321409|NCT00827918|B3|Baseline|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321410|NCT00827918|B2|Baseline|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321411|NCT00827918|B1|Baseline|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321412|NCT00827918|P3|Participant Flow|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321413|NCT00827918|P2|Participant Flow|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321414|NCT00827918|P1|Participant Flow|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321415|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321416|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321417|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321418|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321419|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321420|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321421|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321422|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321423|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321424|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321425|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321426|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321427|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321428|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321429|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321430|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321431|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321432|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321433|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321434|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321435|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321436|NCT00827918|E3|Reported Event|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
321437|NCT00827918|E2|Reported Event|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
321438|NCT00827918|E1|Reported Event|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
321439|NCT00827827|B3|Baseline|Total|Total of all reporting groups
321618|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321440|NCT00827827|B2|Baseline|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321441|NCT00827827|B1|Baseline|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321442|NCT00827827|P2|Participant Flow|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321443|NCT00827827|P1|Participant Flow|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321444|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321445|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321446|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321447|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321448|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321449|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321450|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321451|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321452|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321453|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321685|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
321454|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321455|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321456|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321457|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321458|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321459|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321460|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321461|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321462|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321463|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321464|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321465|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321466|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321467|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321686|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
321468|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321469|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321470|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321471|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321472|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321473|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321474|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321475|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321476|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321477|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321478|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321479|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321480|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321481|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321687|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
321482|NCT00827827|E2|Reported Event|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
321483|NCT00827827|E1|Reported Event|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
321484|NCT00827632|B3|Baseline|Total|Total of all reporting groups
321485|NCT00827632|B2|Baseline|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
321486|NCT00827632|B1|Baseline|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
321487|NCT00827632|P2|Participant Flow|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
321488|NCT00827632|P1|Participant Flow|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
321489|NCT00827632|O2|Outcome|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
321490|NCT00827632|O1|Outcome|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
321491|NCT00827632|E2|Reported Event|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
321492|NCT00827632|E1|Reported Event|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
321493|NCT00827606|B3|Baseline|Total|Total of all reporting groups
321494|NCT00827606|B2|Baseline|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321495|NCT00827606|B1|Baseline|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321496|NCT00827606|P2|Participant Flow|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321497|NCT00827606|P1|Participant Flow|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.
321498|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321499|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321500|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321501|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321502|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321503|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321504|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321505|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321532|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
323993|NCT00819637|E1|Reported Event|Arformoterol 1 Dose, Placebo 2 Doses|
321506|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321507|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321508|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321509|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321510|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321511|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321512|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321513|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321514|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321515|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321516|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321517|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321518|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321519|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321520|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321521|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321522|NCT00827606|O5|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 5|Participants aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321523|NCT00827606|O4|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 4|Participants aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321524|NCT00827606|O3|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 3|Participants aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321525|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 2|Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321526|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Baseline Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321527|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321528|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321529|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321530|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321531|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
323994|NCT00819585|B8|Baseline|Total|Total of all reporting groups
321533|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321534|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321535|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321536|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321537|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321538|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321539|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321540|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321541|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321542|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321543|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321544|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321545|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321546|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321547|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321548|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321549|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321550|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321551|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321552|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321553|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321554|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321555|NCT00827606|E2|Reported Event|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321556|NCT00827606|E1|Reported Event|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
321557|NCT00827567|B1|Baseline|RAD 001|RAD001-10 mg by mouth once everyday
321558|NCT00827567|P1|Participant Flow|RAD 001|RAD001-10 mg by mouth once everyday
321559|NCT00827567|O1|Outcome|RAD 001|RAD001-10 mg by mouth once everyday
321560|NCT00827567|E1|Reported Event|RAD 001|RAD001-10 mg by mouth once everyday
321561|NCT00827541|B3|Baseline|Total|Total of all reporting groups
321562|NCT00827541|B2|Baseline|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321563|NCT00827541|B1|Baseline|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321564|NCT00827541|P2|Participant Flow|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321565|NCT00827541|P1|Participant Flow|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321566|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321567|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321568|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321569|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321570|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321571|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321572|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321573|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321574|NCT00827541|E2|Reported Event|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321575|NCT00827541|E1|Reported Event|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
321576|NCT00827502|B1|Baseline|Azithromycin|
321616|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321617|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
324714|NCT00818753|B4|Baseline|Total|Total of all reporting groups
321577|NCT00827502|P1|Participant Flow|Azithromycin|The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
321578|NCT00827502|O1|Outcome|Azithromycin|
321579|NCT00827502|O1|Outcome|Azithromycin|
321580|NCT00827502|O1|Outcome|Azithromycin|
321581|NCT00827502|E1|Reported Event|Azithromycin|
321582|NCT00827372|B1|Baseline|Overall Study|All patients who were treated
321583|NCT00827372|P1|Participant Flow|Overall Study|All patients who were treated
321584|NCT00827372|O1|Outcome|Overall|All patients who were treated
321585|NCT00827372|O1|Outcome|Overall|All patients who were treated
321586|NCT00827372|O1|Outcome|Overall|All patients who were treated
321587|NCT00827372|O1|Outcome|Overall|All patients who were treated
321588|NCT00827372|O1|Outcome|Overall Study|All patients who were treated
321589|NCT00827372|E1|Reported Event|Overall|All patients who were treated
321590|NCT00827255|B1|Baseline|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
321591|NCT00827255|P1|Participant Flow|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
321592|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
321593|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
321594|NCT00827255|E1|Reported Event|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
321595|NCT00827242|B3|Baseline|Total|Total of all reporting groups
321596|NCT00827242|B2|Baseline|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321597|NCT00827242|B1|Baseline|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321598|NCT00827242|P2|Participant Flow|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321599|NCT00827242|P1|Participant Flow|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321600|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321601|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321602|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321603|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321604|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321605|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321606|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321607|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321608|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321609|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321610|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321611|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321612|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321613|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321614|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321615|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321619|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321620|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321621|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321622|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321623|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321624|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321625|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321626|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321627|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321628|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321629|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321630|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321631|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321632|NCT00827242|E2|Reported Event|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
321633|NCT00827242|E1|Reported Event|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
321634|NCT00827112|B3|Baseline|Total|Total of all reporting groups
321635|NCT00827112|B2|Baseline|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321636|NCT00827112|B1|Baseline|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321637|NCT00827112|P2|Participant Flow|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321638|NCT00827112|P1|Participant Flow|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321639|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321640|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321641|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321642|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321643|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321644|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321645|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321646|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321647|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321648|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321649|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321688|NCT00827073|E2|Reported Event|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
324968|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
321650|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321651|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321652|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321653|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321654|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321655|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321656|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321657|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321658|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321659|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321660|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321661|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321662|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321663|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321664|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321665|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321666|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321667|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
321668|NCT00827112|E2|Reported Event|Atazanavir / Ritonavir + Emtricitabine/ Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
321669|NCT00827112|E1|Reported Event|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
321670|NCT00827099|B1|Baseline|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
321671|NCT00827099|P1|Participant Flow|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
321672|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321673|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321674|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321675|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321676|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321677|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
321678|NCT00827099|E1|Reported Event|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
321679|NCT00827073|B3|Baseline|Total|Total of all reporting groups
321680|NCT00827073|B2|Baseline|Lidocaine 2% Jelly|"betadine: betadine 5%~anesthetic"
321681|NCT00827073|B1|Baseline|Tetracaine 5% Drop|"betadine: betadine 5%~topical anesthetic"
321682|NCT00827073|P2|Participant Flow|Lidocaine 2% Jelly|betadine: betadine 5% Anesthetic: lidocaine 2% jelly
321683|NCT00827073|P1|Participant Flow|Tetracaine 5% Drop|betadine: betadine 5%, topical anesthetic drop
321684|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
321691|NCT00826943|P6|Participant Flow|C Then P Then L|cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
321692|NCT00826943|P5|Participant Flow|C Then L Then P|cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
321693|NCT00826943|P4|Participant Flow|P Then C Then L|placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
321694|NCT00826943|P3|Participant Flow|P Then L Then C|placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
321695|NCT00826943|P2|Participant Flow|L Then P Then C|Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
321696|NCT00826943|P1|Participant Flow|L Then C Then P|Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
321697|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
321698|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
321699|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
321700|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
321701|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
321702|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
321703|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
321704|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
321705|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
321706|NCT00826943|E3|Reported Event|Cetirizine|cross over = all participants received all interventions
321707|NCT00826943|E2|Reported Event|Levocetirizine|cross over (all participants received all interventions)
321708|NCT00826943|E1|Reported Event|Placebo|Cross Over (all participants received all interventions)
321709|NCT00826800|B1|Baseline|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
321710|NCT00826800|P1|Participant Flow|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
321711|NCT00826800|O1|Outcome|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
321712|NCT00826800|E1|Reported Event|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
321713|NCT00826618|B1|Baseline|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
321714|NCT00826618|P1|Participant Flow|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
321715|NCT00826618|O1|Outcome|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
321716|NCT00826618|E1|Reported Event|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
321717|NCT00826540|B1|Baseline|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
321718|NCT00826540|P1|Participant Flow|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
321719|NCT00826540|O1|Outcome|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >~> sorafenib tosylate: Given orally~>~> bevacizumab: Given IV"
321720|NCT00826540|E1|Reported Event|Treatment (Sorafenib Tosylate and Bevacizumab)|bevacizumab: Given IV
321721|NCT00826449|B3|Baseline|Total|Total of all reporting groups
321722|NCT00826449|B2|Baseline|Dasatinib + Erlotinib: Phase 2|MTD from Phase I Dasatinib orally dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321723|NCT00826449|B1|Baseline|Dasatinib + Erlotinib: Phase I|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321724|NCT00826449|P1|Participant Flow|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321725|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321726|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321727|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
322515|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
321728|NCT00826449|E1|Reported Event|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
321729|NCT00826280|B4|Baseline|Total|Total of all reporting groups
321730|NCT00826280|B3|Baseline|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321731|NCT00826280|B2|Baseline|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321732|NCT00826280|B1|Baseline|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321733|NCT00826280|P3|Participant Flow|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321734|NCT00826280|P2|Participant Flow|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321735|NCT00826280|P1|Participant Flow|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321736|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321737|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321738|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321739|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321740|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321741|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321742|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321743|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321744|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321745|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321746|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321747|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321748|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321749|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321750|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321751|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321752|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321753|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321754|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321755|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321756|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321757|NCT00826280|E3|Reported Event|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321758|NCT00826280|E2|Reported Event|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
321759|NCT00826280|E1|Reported Event|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
321760|NCT00826267|B4|Baseline|Total|Total of all reporting groups
321761|NCT00826267|B3|Baseline|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321762|NCT00826267|B2|Baseline|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321763|NCT00826267|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321764|NCT00826267|P3|Participant Flow|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321765|NCT00826267|P2|Participant Flow|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321766|NCT00826267|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321767|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321768|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321995|NCT00825344|E1|Reported Event|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
321769|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321770|NCT00826267|O1|Outcome|Afatinib 50mg|Patients received Afatinib 50 mg at day 7.
321771|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321772|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321773|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321774|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321775|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321776|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321777|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321778|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321779|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321780|NCT00826267|E3|Reported Event|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
321781|NCT00826267|E2|Reported Event|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321782|NCT00826267|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
321783|NCT00826228|B1|Baseline|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
321784|NCT00826228|P1|Participant Flow|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing on a Lokomat
321785|NCT00826228|O1|Outcome|PTH/Weight-Bearing|
321786|NCT00826228|O1|Outcome|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
321787|NCT00826228|E1|Reported Event|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
321788|NCT00826202|B3|Baseline|Total|Total of all reporting groups
321789|NCT00826202|B2|Baseline|Placebo|Placebo: Inert Placebo
321790|NCT00826202|B1|Baseline|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321791|NCT00826202|P2|Participant Flow|Placebo|Placebo: Inert Placebo
321792|NCT00826202|P1|Participant Flow|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321793|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
321794|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321795|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
321796|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321797|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
321798|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321799|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
321800|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321801|NCT00826202|E2|Reported Event|Placebo|Placebo: Inert Placebo
321802|NCT00826202|E1|Reported Event|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
321803|NCT00826176|B3|Baseline|Total|Total of all reporting groups
321804|NCT00826176|B2|Baseline|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321805|NCT00826176|B1|Baseline|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
321806|NCT00826176|P2|Participant Flow|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321807|NCT00826176|P1|Participant Flow|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
321808|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321809|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
321810|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321811|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
321812|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321813|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
322225|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
321814|NCT00826176|E2|Reported Event|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
321815|NCT00826176|E1|Reported Event|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
321816|NCT00826111|B3|Baseline|Total|Total of all reporting groups
321817|NCT00826111|B2|Baseline|Placebo|Escitalopram with placebo
321818|NCT00826111|B1|Baseline|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321819|NCT00826111|P2|Participant Flow|Placebo|Escitalopram with placebo
321820|NCT00826111|P1|Participant Flow|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321821|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321822|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321823|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321824|NCT00826111|O1|Outcome|Eszopiclone|Escitalopram for 10 weeks together with eszopiclone.
321825|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321826|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321827|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321828|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321829|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321830|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321831|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321832|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321833|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321834|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321835|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
321836|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321837|NCT00826111|O2|Outcome|Placebo|Open label escitalopram for 10 weeks together with placebo for 10 weeks.
321838|NCT00826111|O1|Outcome|Eszopiclone|Open label escitalopram for 10 weeks together with 3 mg eszopiclone for eight weeks followed by placebo for two weeks.
321839|NCT00826111|E2|Reported Event|Placebo|Escitalopram with placebo
321840|NCT00826111|E1|Reported Event|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
321841|NCT00826007|B3|Baseline|Total|Total of all reporting groups
321842|NCT00826007|B2|Baseline|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
321843|NCT00826007|B1|Baseline|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
321844|NCT00826007|P2|Participant Flow|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
321845|NCT00826007|P1|Participant Flow|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
321846|NCT00826007|O2|Outcome|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
321847|NCT00826007|O1|Outcome|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
321848|NCT00826007|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
321849|NCT00825994|B1|Baseline|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
321850|NCT00825994|P1|Participant Flow|Omega-3|omega-3 fatty acids, 2g qd [every day] (2 x 1 gram tablets), PO [by mouth]
321851|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
321852|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
321853|NCT00825994|E1|Reported Event|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
321854|NCT00825916|B4|Baseline|Total|Total of all reporting groups
321855|NCT00825916|B3|Baseline|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321856|NCT00825916|B2|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321857|NCT00825916|B1|Baseline|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321858|NCT00825916|P3|Participant Flow|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321859|NCT00825916|P2|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321860|NCT00825916|P1|Participant Flow|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321861|NCT00825916|O9|Outcome|Scar Total Volume - 10 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321862|NCT00825916|O8|Outcome|Scar Total Volume - 3 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321863|NCT00825916|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
322226|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
321864|NCT00825916|O6|Outcome|Scar Negative Volume - 10 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321865|NCT00825916|O5|Outcome|Scar Negative Volume - 3 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321866|NCT00825916|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321867|NCT00825916|O3|Outcome|Scar Positive Volume - 10 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321868|NCT00825916|O2|Outcome|Scar Positive Volume - 3 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321869|NCT00825916|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321870|NCT00825916|O15|Outcome|Scar Mean Elevation - 10 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321871|NCT00825916|O14|Outcome|Scar Mean Elevation - 3 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321872|NCT00825916|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321873|NCT00825916|O12|Outcome|Scar Maximum Elevation - 10 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321874|NCT00825916|O11|Outcome|Scar Maximum Elevation - 3 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321875|NCT00825916|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321876|NCT00825916|O9|Outcome|Scar Minimum Elevation - 10 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321877|NCT00825916|O8|Outcome|Scar Minimum Elevation - 3 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321878|NCT00825916|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321879|NCT00825916|O6|Outcome|Scar Width - 10 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321880|NCT00825916|O5|Outcome|Scar Width - 3 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321881|NCT00825916|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321882|NCT00825916|O3|Outcome|Scar Length - 10 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321883|NCT00825916|O2|Outcome|Scar Length - 3 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321884|NCT00825916|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321885|NCT00825916|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321886|NCT00825916|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321887|NCT00825916|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321888|NCT00825916|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321889|NCT00825916|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321890|NCT00825916|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321891|NCT00825916|O6|Outcome|OSAS Results for 10 mg AZX100|This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321892|NCT00825916|O5|Outcome|OSAS Results for 3 mg AZX100|This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321893|NCT00825916|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321894|NCT00825916|O3|Outcome|PSAS Results for 10 mg AZX100|This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321895|NCT00825916|O2|Outcome|PSAS Results for 3 mg AZX100|This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321896|NCT00825916|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321897|NCT00825916|E3|Reported Event|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321898|NCT00825916|E2|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321899|NCT00825916|E1|Reported Event|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
321900|NCT00825825|B1|Baseline|Entire Study Population|Includes all randomized subjects regardless of order in which they received medications
321901|NCT00825825|P6|Participant Flow|Placebo First / Citalopram Second / Escitalopram Third|2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
321902|NCT00825825|P5|Participant Flow|Placebo First / Escitalopram Second / Citalopram Third|2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram
321903|NCT00825825|P4|Participant Flow|Citalopram First / Placebo Second / Escitalopram Third|2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram
321904|NCT00825825|P3|Participant Flow|Citalopram First / Escitalopram Second / Placebo Third|2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo
321905|NCT00825825|P2|Participant Flow|Escitalopram First / Placebo Second / Citalopram Third|2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram
321906|NCT00825825|P1|Participant Flow|Escitalopram First / Citalopram Second / Placebo Third|2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo
321907|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321908|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321909|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321910|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321911|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321912|NCT00825825|O1|Outcome|All Participants With Complete Usuable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321913|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
321914|NCT00825825|E3|Reported Event|Placebo|Includes all subjects who received placebo in one of the three medication periods
321915|NCT00825825|E2|Reported Event|Citalopram|Includes all subjects who received citalopram in one of the three medication periods
321916|NCT00825825|E1|Reported Event|Escitalopram|Includes all subjects who received escitalopram in one of the three medication periods
321917|NCT00825812|B5|Baseline|Total|Total of all reporting groups
321918|NCT00825812|B4|Baseline|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321919|NCT00825812|B3|Baseline|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321920|NCT00825812|B2|Baseline|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321921|NCT00825812|B1|Baseline|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321922|NCT00825812|P4|Participant Flow|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321923|NCT00825812|P3|Participant Flow|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321924|NCT00825812|P2|Participant Flow|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321925|NCT00825812|P1|Participant Flow|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321926|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321927|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321928|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321929|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321930|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321931|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321932|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321933|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321934|NCT00825812|E4|Reported Event|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321935|NCT00825812|E3|Reported Event|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321936|NCT00825812|E2|Reported Event|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
321937|NCT00825812|E1|Reported Event|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
321938|NCT00825734|B1|Baseline|All Patients|"Patients treated at all dose levels in the Phase I and Phase II portions of the study~: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)~Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)~Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)"
321939|NCT00825734|P3|Participant Flow|Dose Level 1a|Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
321940|NCT00825734|P2|Participant Flow|Dose Level -1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
321941|NCT00825734|P1|Participant Flow|Dose Level 1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
321942|NCT00825734|O1|Outcome|Phase II - Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
321943|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
321944|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
321945|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
321946|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
321947|NCT00825734|E1|Reported Event|Dose Level 1a|Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
321948|NCT00825682|B3|Baseline|Total|Total of all reporting groups
321949|NCT00825682|B2|Baseline|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321950|NCT00825682|B1|Baseline|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
321951|NCT00825682|P2|Participant Flow|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321952|NCT00825682|P1|Participant Flow|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
321953|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321954|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
321955|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321956|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
321957|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321958|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
321959|NCT00825682|E2|Reported Event|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
321960|NCT00825682|E1|Reported Event|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
321961|NCT00825630|B5|Baseline|Total|Total of all reporting groups
321962|NCT00825630|B4|Baseline|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
321963|NCT00825630|B3|Baseline|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
321964|NCT00825630|B2|Baseline|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
321965|NCT00825630|B1|Baseline|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
321966|NCT00825630|P4|Participant Flow|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
321967|NCT00825630|P3|Participant Flow|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
321968|NCT00825630|P2|Participant Flow|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
321969|NCT00825630|P1|Participant Flow|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
321970|NCT00825630|O4|Outcome|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
321971|NCT00825630|O3|Outcome|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
321972|NCT00825630|O2|Outcome|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
321973|NCT00825630|O1|Outcome|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
321974|NCT00825630|E4|Reported Event|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
321975|NCT00825630|E3|Reported Event|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
321976|NCT00825630|E2|Reported Event|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
321977|NCT00825630|E1|Reported Event|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
321978|NCT00825565|B1|Baseline|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
321979|NCT00825565|P1|Participant Flow|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
321980|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the target lesion area for assessing the impact on target wound closure.
321981|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
321982|NCT00825565|E1|Reported Event|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
321983|NCT00825344|B3|Baseline|Total|Total of all reporting groups
321984|NCT00825344|B2|Baseline|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
321985|NCT00825344|B1|Baseline|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
321986|NCT00825344|P2|Participant Flow|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
321987|NCT00825344|P1|Participant Flow|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
322516|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
321996|NCT00825318|B1|Baseline|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
321997|NCT00825318|P1|Participant Flow|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
321998|NCT00825318|O3|Outcome|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
321999|NCT00825318|O2|Outcome|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
322000|NCT00825318|O1|Outcome|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
322001|NCT00825318|E3|Reported Event|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
322002|NCT00825318|E2|Reported Event|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
322003|NCT00825318|E1|Reported Event|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
322004|NCT00825305|B3|Baseline|Total|Total of all reporting groups
322005|NCT00825305|B2|Baseline|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322006|NCT00825305|B1|Baseline|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322007|NCT00825305|P2|Participant Flow|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322008|NCT00825305|P1|Participant Flow|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322009|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322010|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322011|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322012|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322013|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322014|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322015|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322016|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322017|NCT00825305|E2|Reported Event|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
322018|NCT00825305|E1|Reported Event|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
322019|NCT00825227|B3|Baseline|Total|Total of all reporting groups
322020|NCT00825227|B2|Baseline|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
322021|NCT00825227|B1|Baseline|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
322022|NCT00825227|P2|Participant Flow|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
322023|NCT00825227|P1|Participant Flow|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
322024|NCT00825227|O2|Outcome|Armodafinil 150 mg/Day|"150 mg/day armodafinil (3 tablets of 50 mg armodafinil)~taxane chemotherapy treatment alone or in combination with other agents"
322025|NCT00825227|O1|Outcome|Placebo|"Placebo (3 tablets matching armodafinil tablets)~taxane chemotherapy treatment alone or in combination with other agents"
322026|NCT00825227|E2|Reported Event|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
322027|NCT00825227|E1|Reported Event|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
322028|NCT00825175|B3|Baseline|Total|Total of all reporting groups
322029|NCT00825175|B2|Baseline|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
322030|NCT00825175|B1|Baseline|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
322031|NCT00825175|P2|Participant Flow|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
322032|NCT00825175|P1|Participant Flow|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
322033|NCT00825175|O2|Outcome|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
322083|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322034|NCT00825175|O1|Outcome|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
322035|NCT00825175|E2|Reported Event|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
322036|NCT00825175|E1|Reported Event|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
322037|NCT00825162|B4|Baseline|Total|Total of all reporting groups
322038|NCT00825162|B3|Baseline|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322039|NCT00825162|B2|Baseline|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322040|NCT00825162|B1|Baseline|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322041|NCT00825162|P3|Participant Flow|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322042|NCT00825162|P2|Participant Flow|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322043|NCT00825162|P1|Participant Flow|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322044|NCT00825162|O3|Outcome|Cohort C|
322045|NCT00825162|O2|Outcome|Cohort B|
322046|NCT00825162|O1|Outcome|Cohort A|
322047|NCT00825162|O3|Outcome|Cohort C|
322048|NCT00825162|O2|Outcome|Cohort B|
322049|NCT00825162|O1|Outcome|Cohort A|
322050|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
322051|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
322052|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
322053|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
322054|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
322055|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
322056|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
322057|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
322058|NCT00825162|O3|Outcome|Cohort C|
322059|NCT00825162|O2|Outcome|Cohort B|
322060|NCT00825162|O1|Outcome|Cohort A|
322061|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
322062|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
322063|NCT00825162|E3|Reported Event|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322064|NCT00825162|E2|Reported Event|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322065|NCT00825162|E1|Reported Event|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
322066|NCT00824850|B3|Baseline|Total|Total of all reporting groups
322067|NCT00824850|B2|Baseline|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322068|NCT00824850|B1|Baseline|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322069|NCT00824850|P2|Participant Flow|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322070|NCT00824850|P1|Participant Flow|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322071|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322072|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322073|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322074|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322075|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322076|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322077|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322078|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322079|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322080|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322081|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322082|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322517|NCT00824382|O1|Outcome|Placebo|Placebo
322084|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322085|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322086|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322087|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322088|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322089|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322090|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322091|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322092|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322093|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322094|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322095|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322096|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322097|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322098|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322099|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322100|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322101|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322102|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322103|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322104|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322105|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322106|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322107|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322108|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322109|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
322110|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
322111|NCT00824850|E2|Reported Event|MnCC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=20; Local reactions N=36; Systemic events N=36."
322112|NCT00824850|E1|Reported Event|7vPnC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=22; Local reactions N=38; Systemic events N=38."
322113|NCT00824824|B3|Baseline|Total|Total of all reporting groups
322114|NCT00824824|B2|Baseline|POAG With RVD|7 subjects with POAG were identified to have retinal vascular dysregulation (RVD). We determined whether RVD was present in the following way. The percentage change between the retinal blood flow measured while reclining for 30 min and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the retinal blood flow while reclining compared to sitting was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ±2 standard deviations about the mean percentage change found in the control group in our previous study. Subjects with a change in retinal blood flow induced by posture change outside of -17.5% to +35.5% where considered to have RVD.
322160|NCT00824655|B1|Baseline|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322161|NCT00824655|P2|Participant Flow|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322227|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322228|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322115|NCT00824824|B1|Baseline|Primary Open Angle Glaucoma|Subjects of either gender with age range 40 to 80 years old with POAG were eligible for the study. Eligible subjects had a history of an untreated IOP > 21 mmHg in the left eye and a CPSD ≥ 1.0 in this eye. Patients being treated with more than two IOP lowering medications concurrently were excluded. All eligible subjects had open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. All subjects also had at least two reliable Humphrey 24-2 full threshold visual fields that showed reproducible loss in the left eye on tests with fixation loss ≤33%, false positives ≤ 20% and false negatives ≤ 20%. Patients with evidence of exfoliation or pigment dispersion syndrome in either eye were excluded. Subjects with diabetic retinopathy or a history of ocular laser or incisional surgery in either eye were also excluded.
322116|NCT00824824|P2|Participant Flow|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
322117|NCT00824824|P1|Participant Flow|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
322118|NCT00824824|O2|Outcome|Brimonidine-Timolol|Post timolol-brimonidine outcome: 6 of the 7 patients were tested following timolol-brimonidine. One of the 7 patients could not be tested due to technical issues. Of the 6 that were tested, 4 patients had retinal vascular autoregulation that was in the normal range. Two patients continued to show RVD.
322119|NCT00824824|O1|Outcome|Dorzolamide-Timolol|Post timolol-dorzolamide outcome: All 7 patients who had RVD following timolol had retinal vascular autoregulation that was in the normal range.
322120|NCT00824824|E2|Reported Event|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
322121|NCT00824824|E1|Reported Event|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
322122|NCT00824772|B1|Baseline|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
322123|NCT00824772|P1|Participant Flow|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
322124|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
322125|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
322126|NCT00824772|E1|Reported Event|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
322127|NCT00824746|B1|Baseline|Single Arm|Gefitinib retreatment
322128|NCT00824746|P1|Participant Flow|Gefitinib Retreatment Group|Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
322129|NCT00824746|O1|Outcome|Single Arm|Gefitinib retreatment
322130|NCT00824746|O1|Outcome|Gefitinib Retreatment Group|Gefitinib retreatment
322131|NCT00824746|O1|Outcome|Gefitinib Retreatment Arm|Gefitinib retreatment arm
322132|NCT00824746|E1|Reported Event|Single Arm|Gefitinib retreatment
322133|NCT00824733|B1|Baseline|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322134|NCT00824733|P1|Participant Flow|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322135|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322136|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322137|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322138|NCT00824733|E1|Reported Event|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
322139|NCT00824720|B4|Baseline|Total|Total of all reporting groups
322140|NCT00824720|B3|Baseline|Placebo|punctal plug without bimatoprost
322141|NCT00824720|B2|Baseline|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322142|NCT00824720|B1|Baseline|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322143|NCT00824720|P3|Participant Flow|Placebo|punctal plug without bimatoprost
322144|NCT00824720|P2|Participant Flow|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322145|NCT00824720|P1|Participant Flow|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322146|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
322147|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322148|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322149|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
322150|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322151|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322152|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
322153|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322154|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322155|NCT00824720|E3|Reported Event|Placebo|punctal plug without bimatoprost
322156|NCT00824720|E2|Reported Event|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
322157|NCT00824720|E1|Reported Event|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
322158|NCT00824655|B3|Baseline|Total|Total of all reporting groups
322159|NCT00824655|B2|Baseline|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322195|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322287|NCT00824460|B7|Baseline|Total|Total of all reporting groups
322162|NCT00824655|P1|Participant Flow|13vPnC/13vPnC|Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
322163|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322164|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322165|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322166|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322167|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322168|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322169|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322170|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322171|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322172|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322173|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
322174|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
322175|NCT00824655|E4|Reported Event|13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
322176|NCT00824655|E3|Reported Event|13vPnC/13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).
322177|NCT00824655|E2|Reported Event|13vPnC/13vPnC at 6 Months of Age|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).
322178|NCT00824655|E1|Reported Event|13vPnC/13vPnC at 5 Months|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)
322179|NCT00824616|B3|Baseline|Total|Total of all reporting groups
322180|NCT00824616|B2|Baseline|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
322181|NCT00824616|B1|Baseline|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
322182|NCT00824616|P2|Participant Flow|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
322183|NCT00824616|P1|Participant Flow|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
322184|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
322185|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
322186|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
322187|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
322188|NCT00824616|E2|Reported Event|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
322189|NCT00824616|E1|Reported Event|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
322190|NCT00824564|B3|Baseline|Total|Total of all reporting groups
322191|NCT00824564|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322192|NCT00824564|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322193|NCT00824564|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322194|NCT00824564|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322196|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322197|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322198|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322199|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322200|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322201|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322202|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322203|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322204|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322205|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322206|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322207|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322208|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322209|NCT00824564|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
322210|NCT00824564|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
322211|NCT00824538|B1|Baseline|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322212|NCT00824538|P1|Participant Flow|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322213|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322214|NCT00824538|O1|Outcome|Sunitinib|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322215|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322216|NCT00824538|E1|Reported Event|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
322217|NCT00824512|B3|Baseline|Total|Total of all reporting groups
322218|NCT00824512|B2|Baseline|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
322219|NCT00824512|B1|Baseline|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322220|NCT00824512|P2|Participant Flow|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322221|NCT00824512|P1|Participant Flow|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322222|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322223|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322224|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322229|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322230|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322231|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322232|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322233|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322234|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322235|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322236|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322237|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322238|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322239|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322240|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322241|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322242|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322243|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322244|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322245|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322246|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322247|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322248|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322249|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322250|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322251|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322252|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322253|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322254|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322255|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322256|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322257|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322258|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322259|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322260|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322261|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322262|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322263|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322264|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
322265|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322266|NCT00824512|E2|Reported Event|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
322267|NCT00824512|E1|Reported Event|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
322268|NCT00824473|B3|Baseline|Total|Total of all reporting groups
322269|NCT00824473|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322270|NCT00824473|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322271|NCT00824473|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322272|NCT00824473|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322273|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322274|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322275|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322276|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322277|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322278|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322279|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322280|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322281|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322282|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322283|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322284|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322285|NCT00824473|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
322286|NCT00824473|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
322288|NCT00824460|B6|Baseline|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
322289|NCT00824460|B5|Baseline|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322290|NCT00824460|B4|Baseline|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
322291|NCT00824460|B3|Baseline|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322292|NCT00824460|B2|Baseline|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322293|NCT00824460|B1|Baseline|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322294|NCT00824460|P6|Participant Flow|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
322295|NCT00824460|P5|Participant Flow|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322296|NCT00824460|P4|Participant Flow|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
322297|NCT00824460|P3|Participant Flow|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322298|NCT00824460|P2|Participant Flow|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322299|NCT00824460|P1|Participant Flow|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322300|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
322301|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322302|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
322303|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322304|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322305|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322306|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
322307|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5g PA21 (10 tablets)
322308|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
322309|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5g PA21 (6 tablets)
322310|NCT00824460|O2|Outcome|5.0g PA21 (1,000 mg Iron)|Daily dose of 5.0g PA21 (4 tablets)
322311|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25g PA21 (1 tablet)
322312|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
322313|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322314|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
322315|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322316|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322317|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322318|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
322319|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322320|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
322321|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322322|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322323|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322324|NCT00824460|E6|Reported Event|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
322325|NCT00824460|E5|Reported Event|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
322326|NCT00824460|E4|Reported Event|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
322327|NCT00824460|E3|Reported Event|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
322328|NCT00824460|E2|Reported Event|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
322329|NCT00824460|E1|Reported Event|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
322330|NCT00824434|B1|Baseline|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322331|NCT00824434|P1|Participant Flow|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322332|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322333|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322334|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322335|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322336|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322337|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322338|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322339|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322340|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322341|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322342|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322343|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
324969|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
322344|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322345|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322346|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322347|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322348|NCT00824434|E1|Reported Event|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
322349|NCT00824421|B4|Baseline|Total|Total of all reporting groups
322350|NCT00824421|B3|Baseline|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322351|NCT00824421|B2|Baseline|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322352|NCT00824421|B1|Baseline|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322353|NCT00824421|P3|Participant Flow|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322354|NCT00824421|P2|Participant Flow|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322355|NCT00824421|P1|Participant Flow|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322356|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322357|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322358|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322359|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322433|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322443|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322360|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322361|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322362|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322363|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
322364|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322365|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322366|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322367|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322368|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322369|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322370|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322434|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322435|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322436|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322371|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322372|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322373|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322374|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322375|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322376|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322377|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322378|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322379|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322380|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322381|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322382|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322383|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322384|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322385|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322386|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322387|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322388|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322389|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322437|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322438|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322439|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322503|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322390|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322391|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322392|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322393|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322394|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322395|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322396|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322397|NCT00824421|E3|Reported Event|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322398|NCT00824421|E2|Reported Event|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322440|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322441|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322442|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322504|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322399|NCT00824421|E1|Reported Event|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
322400|NCT00824408|B6|Baseline|Total|Total of all reporting groups
322401|NCT00824408|B5|Baseline|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322402|NCT00824408|B4|Baseline|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322403|NCT00824408|B3|Baseline|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322404|NCT00824408|B2|Baseline|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322405|NCT00824408|B1|Baseline|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322406|NCT00824408|P5|Participant Flow|Randomized Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322407|NCT00824408|P4|Participant Flow|Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
322408|NCT00824408|P3|Participant Flow|Randomized Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
322409|NCT00824408|P2|Participant Flow|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322410|NCT00824408|P1|Participant Flow|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322411|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322412|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322413|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322414|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322415|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322416|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322417|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
322418|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322419|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322420|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
322421|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322422|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322423|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
322424|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322425|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322426|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322427|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322428|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322429|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322430|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322431|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322432|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322444|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322445|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322446|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322447|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322448|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322449|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322450|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322451|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322452|NCT00824408|E5|Reported Event|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322453|NCT00824408|E4|Reported Event|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
322454|NCT00824408|E3|Reported Event|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
322455|NCT00824408|E2|Reported Event|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
322456|NCT00824408|E1|Reported Event|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
322457|NCT00824382|B5|Baseline|Total|Total of all reporting groups
322458|NCT00824382|B4|Baseline|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322459|NCT00824382|B3|Baseline|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322460|NCT00824382|B2|Baseline|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322461|NCT00824382|B1|Baseline|Placebo|Placebo
322462|NCT00824382|P4|Participant Flow|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322463|NCT00824382|P3|Participant Flow|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322464|NCT00824382|P2|Participant Flow|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322465|NCT00824382|P1|Participant Flow|Placebo|Placebo
322466|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322467|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322468|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322469|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322470|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322471|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322472|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322473|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322474|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322475|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322476|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322477|NCT00824382|O1|Outcome|Placebo|Placebo
322478|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322479|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322480|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322481|NCT00824382|O1|Outcome|Placebo|Placebo
322482|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322483|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322484|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322485|NCT00824382|O1|Outcome|Placebo|Placebo
322486|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322487|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322488|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322489|NCT00824382|O1|Outcome|Placebo|Placebo
322490|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322491|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322492|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322493|NCT00824382|O1|Outcome|Placebo|Placebo
322494|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322495|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322496|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322497|NCT00824382|O1|Outcome|Placebo|Placebo
322498|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322499|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322500|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322501|NCT00824382|O1|Outcome|Placebo|Placebo
322502|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322518|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322519|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322520|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322521|NCT00824382|O1|Outcome|Placebo|Placebo
322522|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322523|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322524|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322525|NCT00824382|O1|Outcome|Placebo|Placebo
322526|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322527|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322528|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322529|NCT00824382|O1|Outcome|Placebo|Placebo
322530|NCT00824382|E4|Reported Event|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
322531|NCT00824382|E3|Reported Event|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
322532|NCT00824382|E2|Reported Event|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
322533|NCT00824382|E1|Reported Event|Placebo|Placebo
322534|NCT00824369|B7|Baseline|Total|Total of all reporting groups
322535|NCT00824369|B6|Baseline|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322536|NCT00824369|B5|Baseline|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322537|NCT00824369|B4|Baseline|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322538|NCT00824369|B3|Baseline|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322539|NCT00824369|B2|Baseline|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322540|NCT00824369|B1|Baseline|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322541|NCT00824369|P6|Participant Flow|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322542|NCT00824369|P5|Participant Flow|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322543|NCT00824369|P4|Participant Flow|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322544|NCT00824369|P3|Participant Flow|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322545|NCT00824369|P2|Participant Flow|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322546|NCT00824369|P1|Participant Flow|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322547|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322548|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322549|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322550|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322551|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322552|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322553|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322554|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322555|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322556|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322557|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322558|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322559|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322560|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322561|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322562|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322563|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322564|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322794|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322565|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322566|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322567|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322568|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322569|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322570|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322571|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322572|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322573|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322574|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322575|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322576|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322577|NCT00824369|E6|Reported Event|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
322578|NCT00824369|E5|Reported Event|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
322579|NCT00824369|E4|Reported Event|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
322580|NCT00824369|E3|Reported Event|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
322581|NCT00824369|E2|Reported Event|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
322582|NCT00824369|E1|Reported Event|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
322583|NCT00824291|B3|Baseline|Total|Total of all reporting groups
322584|NCT00824291|B2|Baseline|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322585|NCT00824291|B1|Baseline|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322586|NCT00824291|P2|Participant Flow|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322587|NCT00824291|P1|Participant Flow|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322588|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322589|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322590|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322591|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322592|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322593|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322594|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322595|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322596|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322597|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322598|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322599|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322600|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322601|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322602|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322603|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322604|NCT00824291|E2|Reported Event|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
322605|NCT00824291|E1|Reported Event|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
322606|NCT00824265|B3|Baseline|Total|Total of all reporting groups
323308|NCT00822588|E2|Reported Event|No Sangvia|No autologous blood transfusion.
322607|NCT00824265|B2|Baseline|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322608|NCT00824265|B1|Baseline|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322609|NCT00824265|P2|Participant Flow|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322610|NCT00824265|P1|Participant Flow|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322611|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322612|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322613|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322614|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322615|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322616|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322617|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322618|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322619|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322620|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322621|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322622|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322623|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322624|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322625|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322626|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322627|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322628|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322629|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322630|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322631|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322632|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322633|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322634|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322708|NCT00822185|B3|Baseline|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322709|NCT00822185|B2|Baseline|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322635|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322636|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322637|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322638|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322639|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322640|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322641|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322642|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322643|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322644|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322645|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322646|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322647|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322648|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322710|NCT00822185|B1|Baseline|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322711|NCT00822185|P5|Participant Flow|Placebo|A single dose of placebo was administered intravenously
322649|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322650|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322651|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322652|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322653|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322654|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322655|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322656|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322657|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322658|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322659|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322660|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322661|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322662|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322712|NCT00822185|P4|Participant Flow|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322713|NCT00822185|P3|Participant Flow|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322663|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322664|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322665|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322666|NCT00824265|E2|Reported Event|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322667|NCT00824265|E1|Reported Event|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
322668|NCT00824161|B1|Baseline|TAS-109|TAS-109 2.0 mg/m^2/day
322669|NCT00824161|P1|Participant Flow|TAS-109|TAS-109 2.0 mg/m^2/day
322670|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
322671|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
322672|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day Independent Assessment
322673|NCT00824161|E1|Reported Event|TAS-109|TAS-109 2.0 mg/m^2/day
322674|NCT00824070|B4|Baseline|Total|Total of all reporting groups
322675|NCT00824070|B3|Baseline|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
322676|NCT00824070|B2|Baseline|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
322677|NCT00824070|B1|Baseline|Besifloxacin|Besifloxacin ophthalmic suspension
322678|NCT00824070|P3|Participant Flow|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
322679|NCT00824070|P2|Participant Flow|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
322680|NCT00824070|P1|Participant Flow|Besifloxacin|Besifloxacin ophthalmic suspension
322681|NCT00824070|O3|Outcome|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
322682|NCT00824070|O2|Outcome|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
322683|NCT00824070|O1|Outcome|Besifloxacin|Besifloxacin ophthalmic suspension
322684|NCT00824070|E3|Reported Event|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
322685|NCT00824070|E2|Reported Event|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
322686|NCT00824070|E1|Reported Event|Besifloxacin|Besifloxacin ophthalmic suspension
322687|NCT00824044|B3|Baseline|Total|Total of all reporting groups
322688|NCT00824044|B2|Baseline|Escitalopram|
322689|NCT00824044|B1|Baseline|Cognitive Behavioral Therapy (CBT)|
322690|NCT00824044|P2|Participant Flow|Escitalopram|
322691|NCT00824044|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|
322692|NCT00824044|O2|Outcome|Escitalopram|Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
322693|NCT00824044|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
322694|NCT00824044|E2|Reported Event|Escitalopram|
322695|NCT00824044|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|
322696|NCT00823264|B3|Baseline|Total|Total of all reporting groups
322697|NCT00823264|B2|Baseline|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
322698|NCT00823264|B1|Baseline|Control|Will not receive activated charcoal. Serum levels will be followed.
322699|NCT00823264|P2|Participant Flow|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
322700|NCT00823264|P1|Participant Flow|Control|Will not receive activated charcoal. Serum levels will be followed.
322701|NCT00823264|O2|Outcome|Multiple Doses of Activated Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
322702|NCT00823264|O1|Outcome|Control|Will not receive activated charcoal. Serum levels will be followed.
322703|NCT00823264|E2|Reported Event|Control|Will not receive activated charcoal. Serum levels will be followed.
322704|NCT00823264|E1|Reported Event|Multiple Doses of Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
322705|NCT00822185|B6|Baseline|Total|Total of all reporting groups
322706|NCT00822185|B5|Baseline|Placebo|A single dose of placebo was administered intravenously
322707|NCT00822185|B4|Baseline|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322714|NCT00822185|P2|Participant Flow|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322715|NCT00822185|P1|Participant Flow|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322716|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322717|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322718|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322719|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322720|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322721|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322722|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322723|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322724|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322725|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322726|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322727|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322728|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322729|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322730|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322731|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322732|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322733|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322734|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322735|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322736|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322737|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322738|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322739|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322740|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322741|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322742|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322743|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322744|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322745|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322746|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322747|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322748|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322749|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322750|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322751|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322752|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322753|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322754|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322755|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322756|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322757|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322758|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322759|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322760|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322761|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322762|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322763|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322764|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
322765|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322766|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322767|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322768|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322769|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
322770|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322771|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322772|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322773|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322774|NCT00822185|E5|Reported Event|Placebo|A single dose of placebo was administered intravenously
322775|NCT00822185|E4|Reported Event|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
322776|NCT00822185|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
322777|NCT00822185|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
322778|NCT00822185|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
322779|NCT00822172|B3|Baseline|Total|Total of all reporting groups
322780|NCT00822172|B2|Baseline|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322781|NCT00822172|B1|Baseline|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322782|NCT00822172|P2|Participant Flow|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322783|NCT00822172|P1|Participant Flow|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322784|NCT00822172|O2|Outcome|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322785|NCT00822172|O1|Outcome|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322786|NCT00822172|E2|Reported Event|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322787|NCT00822172|E1|Reported Event|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
322788|NCT00824005|B3|Baseline|Total|Total of all reporting groups
322789|NCT00824005|B2|Baseline|Active Stem Cell Injections|Participants will receive active stem cell injections.
322790|NCT00824005|B1|Baseline|Placebo Injections|Participants will receive placebo injections.
322791|NCT00824005|P2|Participant Flow|Active Stem Cell Injections|Participants will receive active stem cell injections.
322792|NCT00824005|P1|Participant Flow|Placebo Injections|Participants will receive placebo injections.
322793|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322795|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322796|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322797|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322798|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322799|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322800|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322801|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322802|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322803|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322804|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322805|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322806|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322807|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322808|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322809|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322810|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322811|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322812|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322813|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322814|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322815|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322816|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322817|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322818|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322819|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
322820|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
322821|NCT00824005|E2|Reported Event|Active Stem Cell Injections|Participants received active stem cell injections.
322822|NCT00824005|E1|Reported Event|Placebo Injections|Participants received placebo injections.
322823|NCT00823979|B4|Baseline|Total|Total of all reporting groups
322824|NCT00823979|B3|Baseline|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322825|NCT00823979|B2|Baseline|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322826|NCT00823979|B1|Baseline|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322827|NCT00823979|P3|Participant Flow|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322828|NCT00823979|P2|Participant Flow|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322829|NCT00823979|P1|Participant Flow|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322830|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322831|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322832|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322833|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322834|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322835|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322836|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322837|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322838|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322839|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322840|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322841|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322842|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322843|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322844|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322845|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322846|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322847|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322848|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322849|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322850|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322851|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322852|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322853|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322854|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322855|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322856|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322857|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322858|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322859|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322860|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322861|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322862|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322863|NCT00823979|E3|Reported Event|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322864|NCT00823979|E2|Reported Event|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322865|NCT00823979|E1|Reported Event|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
322866|NCT00823966|B1|Baseline|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
322867|NCT00823966|P1|Participant Flow|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
322868|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
322869|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
322870|NCT00823966|E1|Reported Event|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
322871|NCT00823901|B3|Baseline|Total|Total of all reporting groups
322872|NCT00823901|B2|Baseline|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
322873|NCT00823901|B1|Baseline|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
322874|NCT00823901|P2|Participant Flow|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
322875|NCT00823901|P1|Participant Flow|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
322876|NCT00823901|O2|Outcome|Placebo|Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
322877|NCT00823901|O1|Outcome|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
322878|NCT00823901|E2|Reported Event|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
322879|NCT00823901|E1|Reported Event|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
322880|NCT00823836|B3|Baseline|Total|Total of all reporting groups
322881|NCT00823836|B2|Baseline|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322882|NCT00823836|B1|Baseline|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322883|NCT00823836|P2|Participant Flow|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322884|NCT00823836|P1|Participant Flow|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322885|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322886|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322887|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322888|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
323309|NCT00822588|E1|Reported Event|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
322889|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322890|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322891|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322892|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322893|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322894|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322895|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322896|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
323005|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
322897|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322898|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322899|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322900|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322901|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322902|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322903|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322904|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
323016|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323310|NCT00822523|B4|Baseline|Total|Total of all reporting groups
322905|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322906|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322907|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322908|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322909|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322910|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322911|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322912|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322913|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322914|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322915|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322916|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322917|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322918|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322919|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322920|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322921|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322922|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322923|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322924|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322925|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322926|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322927|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322928|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322929|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322930|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322931|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322932|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322933|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322934|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322935|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322936|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322937|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322938|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322939|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322940|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322941|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322942|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322943|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322944|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322945|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322946|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322947|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322948|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322949|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322950|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322951|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322952|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322953|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322954|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322955|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322956|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322957|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322958|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322959|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322960|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322961|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322962|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322963|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322964|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322965|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322966|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322967|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322968|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322969|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322970|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322971|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322972|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322973|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322974|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322975|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322976|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322977|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322978|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322979|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322980|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322981|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322982|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322983|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322984|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322985|NCT00823836|E2|Reported Event|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322986|NCT00823836|E1|Reported Event|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
322987|NCT00823823|B3|Baseline|Total|Total of all reporting groups
322988|NCT00823823|B2|Baseline|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
322989|NCT00823823|B1|Baseline|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
322990|NCT00823823|P2|Participant Flow|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
322991|NCT00823823|P1|Participant Flow|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
322992|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
322993|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
322994|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
322995|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
322996|NCT00823823|E2|Reported Event|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
322997|NCT00823823|E1|Reported Event|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
322998|NCT00823719|B3|Baseline|Total|Total of all reporting groups
322999|NCT00823719|B2|Baseline|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323000|NCT00823719|B1|Baseline|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323001|NCT00823719|P2|Participant Flow|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323002|NCT00823719|P1|Participant Flow|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323003|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323004|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323074|NCT00823303|B3|Baseline|Total|Total of all reporting groups
323396|NCT00822354|O1|Outcome|Pre-treatment|
323006|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323007|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323008|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323009|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323010|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323011|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323012|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323013|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323014|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323015|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323017|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323018|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323019|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323020|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323021|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323022|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323023|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323024|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323025|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323026|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323397|NCT00822354|O4|Outcome|Week 4 of Placebo|
323398|NCT00822354|O3|Outcome|Pre-placebo|
323027|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323028|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323029|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323030|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323031|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323032|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323033|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323034|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323035|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323036|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323037|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323038|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323039|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323040|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323041|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323042|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323043|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323044|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323045|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323046|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323075|NCT00823303|B2|Baseline|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
323047|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323048|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323049|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323050|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323051|NCT00823719|E3|Reported Event|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323052|NCT00823719|E2|Reported Event|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
323053|NCT00823719|E1|Reported Event|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
323054|NCT00823615|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects
323055|NCT00823615|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
323056|NCT00823615|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
323057|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323058|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323059|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323060|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323061|NCT00823615|E2|Reported Event|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323062|NCT00823615|E1|Reported Event|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
323063|NCT00823472|B3|Baseline|Total|Total of all reporting groups
323064|NCT00823472|B2|Baseline|Start rFSH on Cycle Day 5|
323065|NCT00823472|B1|Baseline|Start rFSH Cycle Day 2|
323066|NCT00823472|P2|Participant Flow|Start rFSH on Cycle Day 5|
323067|NCT00823472|P1|Participant Flow|Start rFSH Cycle Day 2|
323068|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
323069|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
323070|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
323071|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
323072|NCT00823472|E2|Reported Event|Start rFSH on Cycle Day 5|
323073|NCT00823472|E1|Reported Event|Start rFSH Cycle Day 2|
323076|NCT00823303|B1|Baseline|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
323077|NCT00823303|P2|Participant Flow|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
323078|NCT00823303|P1|Participant Flow|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
323079|NCT00823303|O2|Outcome|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
323080|NCT00823303|O1|Outcome|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
323081|NCT00823303|E2|Reported Event|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
323082|NCT00823303|E1|Reported Event|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
323083|NCT00823212|B3|Baseline|Total|Total of all reporting groups
323084|NCT00823212|B2|Baseline|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323085|NCT00823212|B1|Baseline|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323086|NCT00823212|P2|Participant Flow|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323087|NCT00823212|P1|Participant Flow|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323088|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323089|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323090|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323091|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323092|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323093|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323094|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323095|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323096|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323097|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323098|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323099|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323100|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323101|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323102|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323103|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323104|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323105|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323106|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323107|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323108|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323109|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323110|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323111|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323112|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323113|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323114|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323115|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323116|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323117|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323118|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323119|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323120|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323121|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323122|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323123|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323124|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323125|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323126|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323127|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323128|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323129|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323130|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323131|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323132|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323133|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323134|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323135|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323136|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323137|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323138|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323139|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323140|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323141|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323142|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323143|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323144|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323145|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323146|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323147|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323148|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323149|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323150|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323151|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323152|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323153|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323154|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323155|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323156|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323157|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323158|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323159|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323160|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323161|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323162|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323163|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323164|NCT00823212|O2|Outcome|PROMUS Element|PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
323165|NCT00823212|O1|Outcome|PROMUS|PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
323166|NCT00823212|E2|Reported Event|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
323167|NCT00823212|E1|Reported Event|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
323168|NCT00823199|B1|Baseline|Group 1|
323169|NCT00823199|P1|Participant Flow|Allopurinal Treatment|
323170|NCT00823199|O1|Outcome|Allopurinal Treatment|
323171|NCT00823199|O1|Outcome|Allopurinal Treatment|
323172|NCT00823199|O1|Outcome|Allopurinal Treatment|
323173|NCT00823199|E1|Reported Event|Group 1|
323174|NCT00823095|B1|Baseline|Group 1|Treatment
323302|NCT00822588|B2|Baseline|No Sangvia|No autologous blood transfusion.
323175|NCT00823095|P1|Participant Flow|Topically Applied Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
323176|NCT00823095|O1|Outcome|Treatment|reduction in bioburden as assessed by number of cfu's per cm2 on culture
323177|NCT00823095|O1|Outcome|Group 1|Treatment
323178|NCT00823095|E1|Reported Event|Group 1|Treatment
323179|NCT00823082|B3|Baseline|Total|Total of all reporting groups
323180|NCT00823082|B2|Baseline|Control Group|No preoperative ATIII supplementation administered
323181|NCT00823082|B1|Baseline|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323182|NCT00823082|P2|Participant Flow|Control Group|No preoperative ATIII supplementation administered
323183|NCT00823082|P1|Participant Flow|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323184|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323185|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323186|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323187|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323188|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323189|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323190|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323191|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323192|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323193|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323194|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323195|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323196|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323197|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323198|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323199|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323200|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323201|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323202|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323203|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323204|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323205|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323206|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323207|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323208|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323209|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323210|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323211|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323212|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
323213|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323214|NCT00823082|E2|Reported Event|Control Group|No preoperative ATII supplementation administered
323215|NCT00823082|E1|Reported Event|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
323216|NCT00823069|B1|Baseline|Perlane and Perlane-L|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
323217|NCT00823069|P1|Participant Flow|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
323218|NCT00823069|O2|Outcome|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
323219|NCT00823069|O1|Outcome|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
323220|NCT00823069|O1|Outcome|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
323221|NCT00823069|E2|Reported Event|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
323222|NCT00823069|E1|Reported Event|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
323223|NCT00823043|B1|Baseline|Total Subject Population|All subjects responding to survey
323224|NCT00823043|P2|Participant Flow|Timolol Maleate in Sorbate|Timolol maleate in sorbate 0.5% ophthalmic solution
323225|NCT00823043|P1|Participant Flow|Timolol Hemihydrate|Timolol hemihydrate 0.5% ophthalmic solution.
323226|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
323227|NCT00823043|O1|Outcome|Timolol Hemihydrate|
323228|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
323229|NCT00823043|O1|Outcome|Timolol Hemihydrate|
323230|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
323231|NCT00823043|O1|Outcome|Timolol Hemihydrate|
323232|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
323233|NCT00823043|O1|Outcome|Timolol Hemihydrate|
323234|NCT00823043|E1|Reported Event|Total Subjects Surveyed|
323235|NCT00822900|B3|Baseline|Total|Total of all reporting groups
323236|NCT00822900|B2|Baseline|Placebo|
323237|NCT00822900|B1|Baseline|Progesterone|
323238|NCT00822900|P2|Participant Flow|Placebo|
323239|NCT00822900|P1|Participant Flow|Progesterone|
323240|NCT00822900|O2|Outcome|Placebo|
323241|NCT00822900|O1|Outcome|Progesterone|
323242|NCT00822900|O2|Outcome|Placebo|
323243|NCT00822900|O1|Outcome|Progesterone|
323244|NCT00822900|O2|Outcome|Placebo|
323245|NCT00822900|O1|Outcome|Progesterone|
323246|NCT00822900|O2|Outcome|Placebo|
323247|NCT00822900|O1|Outcome|Progesterone|
323248|NCT00822900|O2|Outcome|Placebo|
323249|NCT00822900|O1|Outcome|Progesterone|
323250|NCT00822900|O2|Outcome|Placebo|
323251|NCT00822900|O1|Outcome|Progesterone|
323252|NCT00822900|O2|Outcome|Placebo|
323253|NCT00822900|O1|Outcome|Progesterone|
323254|NCT00822900|O2|Outcome|Placebo|
323255|NCT00822900|O1|Outcome|Progesterone|
323256|NCT00822900|O2|Outcome|Placebo|
323257|NCT00822900|O1|Outcome|Progesterone|
323258|NCT00822900|O2|Outcome|Placebo|
323259|NCT00822900|O1|Outcome|Progesterone|
323260|NCT00822900|O2|Outcome|Placebo|
323261|NCT00822900|O1|Outcome|Progesterone|
323262|NCT00822900|O2|Outcome|Placebo|
323263|NCT00822900|O1|Outcome|Progesterone|
323264|NCT00822900|E2|Reported Event|Placebo|
323265|NCT00822900|E1|Reported Event|Progesterone|
323266|NCT00822770|B1|Baseline|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
323303|NCT00822588|B1|Baseline|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
323304|NCT00822588|P2|Participant Flow|No Sangvia|No autologous blood transfusion.
323305|NCT00822588|P1|Participant Flow|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
323306|NCT00822588|O2|Outcome|No Sangvia|No autologous blood transfusion.
323307|NCT00822588|O1|Outcome|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
323267|NCT00822770|P1|Participant Flow|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~Thymoglobulin (ATG) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
323268|NCT00822770|O1|Outcome|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
323269|NCT00822770|E1|Reported Event|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
323270|NCT00822757|B3|Baseline|Total|Total of all reporting groups
323271|NCT00822757|B2|Baseline|Placebo|Saline placebo single dose at baseline.
323272|NCT00822757|B1|Baseline|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
323273|NCT00822757|P2|Participant Flow|Placebo|Saline placebo single dose at baseline.
323274|NCT00822757|P1|Participant Flow|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
323275|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
323276|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
323277|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
323278|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
323279|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
323280|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
323281|NCT00822757|E2|Reported Event|Placebo|Saline placebo single dose at baseline.
323282|NCT00822757|E1|Reported Event|V710 (60 mcg) Lyophilized|V710 (60 mcg)single dose at baseline.
323283|NCT00822692|B3|Baseline|Total|Total of all reporting groups
323284|NCT00822692|B2|Baseline|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
323285|NCT00822692|B1|Baseline|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
323286|NCT00822692|P2|Participant Flow|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
323287|NCT00822692|P1|Participant Flow|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
323288|NCT00822692|O2|Outcome|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
323289|NCT00822692|O1|Outcome|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
323290|NCT00822692|E2|Reported Event|Matched Placebo 2 Pills PO BID x 7 Days|matched placebo 2 pills PO BID x 7 days
323291|NCT00822692|E1|Reported Event|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|bactrim DS (800/160) two tablets PO BID x 7 days
323292|NCT00822679|B3|Baseline|Total|Total of all reporting groups
323293|NCT00822679|B2|Baseline|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
323294|NCT00822679|B1|Baseline|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
323295|NCT00822679|P2|Participant Flow|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
323296|NCT00822679|P1|Participant Flow|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
323297|NCT00822679|O2|Outcome|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
323298|NCT00822679|O1|Outcome|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
323299|NCT00822679|E2|Reported Event|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
323300|NCT00822679|E1|Reported Event|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
323301|NCT00822588|B3|Baseline|Total|Total of all reporting groups
323311|NCT00822523|B3|Baseline|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323312|NCT00822523|B2|Baseline|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323313|NCT00822523|B1|Baseline|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323314|NCT00822523|P3|Participant Flow|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323315|NCT00822523|P2|Participant Flow|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323316|NCT00822523|P1|Participant Flow|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323317|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323318|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323319|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323320|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323321|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323322|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323323|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323324|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323325|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323326|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323327|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323328|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323329|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323330|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323331|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323399|NCT00822354|O2|Outcome|Week 4 of Treatment|
323332|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323333|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323334|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323335|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323336|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323337|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323338|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323339|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323340|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323341|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323342|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323343|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323344|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323345|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323346|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323347|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323348|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323349|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323350|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323351|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323352|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323353|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323354|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323355|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323356|NCT00822523|E3|Reported Event|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
323400|NCT00822354|O1|Outcome|Pre-treatment|
323401|NCT00822354|O4|Outcome|Week 4 of Placebo|
323402|NCT00822354|O3|Outcome|Pre-placebo|
323357|NCT00822523|E2|Reported Event|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
323358|NCT00822523|E1|Reported Event|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
323359|NCT00822510|B3|Baseline|Total|Total of all reporting groups
323360|NCT00822510|B2|Baseline|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323361|NCT00822510|B1|Baseline|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323362|NCT00822510|P2|Participant Flow|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323363|NCT00822510|P1|Participant Flow|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323364|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323365|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323366|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323367|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323368|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323369|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323370|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323371|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323372|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323373|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323374|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.~Telephone delivered education only: Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation"
323375|NCT00822510|O1|Outcome|Telephone Interpersonal Counseling|"Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.~Telephone Interpersonal Counseling: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy."
323376|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323377|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323378|NCT00822510|E2|Reported Event|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
323379|NCT00822510|E1|Reported Event|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
323380|NCT00822354|B3|Baseline|Total|Total of all reporting groups
323381|NCT00822354|B2|Baseline|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
323382|NCT00822354|B1|Baseline|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
323383|NCT00822354|P2|Participant Flow|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
323384|NCT00822354|P1|Participant Flow|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
323385|NCT00822354|O4|Outcome|Week 4 of Placebo|
323386|NCT00822354|O3|Outcome|Pre-placebo|
323387|NCT00822354|O2|Outcome|Week 4 of Treatment|
323388|NCT00822354|O1|Outcome|Pre-treatment|
323389|NCT00822354|O4|Outcome|Week 4 of Placebo|
323390|NCT00822354|O3|Outcome|Pre-placebo|
323391|NCT00822354|O2|Outcome|Week 4 of Treatment|
323392|NCT00822354|O1|Outcome|Pre-treatment|
323393|NCT00822354|O4|Outcome|Week 4 of Placebo|
323394|NCT00822354|O3|Outcome|Pre-placebo|
323395|NCT00822354|O2|Outcome|Week 4 of Treatment|
323409|NCT00822354|E2|Reported Event|Placebo|Subjects received placebo every other day for four weeks
323410|NCT00822354|E1|Reported Event|Tadalafil|Subjects received tadalafil 20 mg every other day for four weeks.
323411|NCT00822328|B3|Baseline|Total|Total of all reporting groups
323412|NCT00822328|B2|Baseline|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
323413|NCT00822328|B1|Baseline|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
323414|NCT00822328|P2|Participant Flow|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
323415|NCT00822328|P1|Participant Flow|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
323416|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
323417|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
323418|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
323419|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
323420|NCT00822328|E2|Reported Event|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
323421|NCT00822328|E1|Reported Event|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
323422|NCT00822237|B3|Baseline|Total|Total of all reporting groups
323423|NCT00822237|B2|Baseline|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
323424|NCT00822237|B1|Baseline|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
323425|NCT00822237|P2|Participant Flow|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
323426|NCT00822237|P1|Participant Flow|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
323427|NCT00822237|O1|Outcome|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
323428|NCT00822237|E2|Reported Event|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
323429|NCT00822237|E1|Reported Event|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
323430|NCT00821951|B1|Baseline|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
323431|NCT00821951|P1|Participant Flow|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
323432|NCT00821951|O1|Outcome|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
323433|NCT00821951|E1|Reported Event|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
323434|NCT00821886|B1|Baseline|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323435|NCT00821886|P1|Participant Flow|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323515|NCT00821327|B1|Baseline|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
323436|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323437|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323438|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323439|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323440|NCT00821886|E1|Reported Event|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
323441|NCT00821873|B1|Baseline|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
323442|NCT00821873|P1|Participant Flow|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
323443|NCT00821873|O1|Outcome|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
323444|NCT00821873|E1|Reported Event|Adverse Events|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
323445|NCT00821821|B4|Baseline|Total|Total of all reporting groups
323446|NCT00821821|B3|Baseline|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
323447|NCT00821821|B2|Baseline|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
323448|NCT00821821|B1|Baseline|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
323449|NCT00821821|P3|Participant Flow|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
323450|NCT00821821|P2|Participant Flow|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
323451|NCT00821821|P1|Participant Flow|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
323452|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone:circa 2000mg / 72-hour infusion
323453|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone:circa 1000mg / 72-hour infusion
323454|NCT00821821|O3|Outcome|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
323455|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
323456|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
323457|NCT00821821|E3|Reported Event|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
323458|NCT00821821|E2|Reported Event|MCI-186 Cohort2|Edaravone: circa 2000mg / 72-hour infusion
323459|NCT00821821|E1|Reported Event|MCI-186 Cohort1|Edaravone: circa 1000mg / 72-hour infusion
323460|NCT00821678|B3|Baseline|Total|Total of all reporting groups
323461|NCT00821678|B2|Baseline|Arm 2 Treatment as Usual|Treatment as usual
323619|NCT00820612|B2|Baseline|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323620|NCT00820612|B1|Baseline|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323462|NCT00821678|B1|Baseline|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323463|NCT00821678|P2|Participant Flow|Arm 2 Treatment as Usual|Treatment as usual
323464|NCT00821678|P1|Participant Flow|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323465|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323466|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323467|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323468|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323469|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323470|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323471|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323472|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323473|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323474|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323475|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
323621|NCT00820612|P2|Participant Flow|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323622|NCT00820612|P1|Participant Flow|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323476|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323477|NCT00821678|E2|Reported Event|Arm 2 Treatment as Usual|Treatment as usual
323478|NCT00821678|E1|Reported Event|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
323479|NCT00821587|B3|Baseline|Total|Total of all reporting groups
323480|NCT00821587|B2|Baseline|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
323481|NCT00821587|B1|Baseline|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
323482|NCT00821587|P2|Participant Flow|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
323483|NCT00821587|P1|Participant Flow|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
323484|NCT00821587|O2|Outcome|Cyclosporine (CsA)|Cyclosporine 2.0–4.0 mg/kg/day orally in two divided doses
323485|NCT00821587|O1|Outcome|Tacrolimus (TAC)|Tacrolimus 0.08–0.12 mg/kg/day orally in two divided doses
323486|NCT00821587|E2|Reported Event|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
323487|NCT00821587|E1|Reported Event|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
323488|NCT00821509|B4|Baseline|Total|Total of all reporting groups
323489|NCT00821509|B3|Baseline|Control|No change in hygiene behaviour
323490|NCT00821509|B2|Baseline|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
323491|NCT00821509|B1|Baseline|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
323492|NCT00821509|P3|Participant Flow|Control|No change in hygiene behaviour
323493|NCT00821509|P2|Participant Flow|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
323494|NCT00821509|P1|Participant Flow|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
323495|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
323496|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
323497|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
323498|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
323499|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
323500|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
323501|NCT00821509|E3|Reported Event|Control|No change in hygiene behaviour
323502|NCT00821509|E2|Reported Event|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
323503|NCT00821509|E1|Reported Event|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
323504|NCT00821431|B3|Baseline|Total|Total of all reporting groups
323516|NCT00821327|P1|Participant Flow|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
324970|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
323505|NCT00821431|B2|Baseline|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
323506|NCT00821431|B1|Baseline|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
323507|NCT00821431|P2|Participant Flow|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
323508|NCT00821431|P1|Participant Flow|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
323509|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
323510|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
323511|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
323512|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
323513|NCT00821431|E2|Reported Event|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
323514|NCT00821431|E1|Reported Event|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
323605|NCT00820664|B4|Baseline|Total|Total of all reporting groups
323606|NCT00820664|B3|Baseline|Placebo|
323607|NCT00820664|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
323608|NCT00820664|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
323609|NCT00820664|P3|Participant Flow|Placebo|
323517|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
323518|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
323519|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
323520|NCT00821327|E1|Reported Event|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
323521|NCT00821236|B4|Baseline|Total|Total of all reporting groups
323522|NCT00821236|B3|Baseline|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
323523|NCT00821236|B2|Baseline|AMO/VISX CustomVue|AMO/VISX CustomVue™
323524|NCT00821236|B1|Baseline|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
323525|NCT00821236|P1|Participant Flow|Lasik for Treatment of Nearsightedness|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
323526|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
323527|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
323528|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
323529|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
323530|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
323531|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
323532|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
323533|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
323534|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
323535|NCT00821236|E3|Reported Event|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
323536|NCT00821236|E2|Reported Event|AMO/VISX CustomVue|AMO/VISX CustomVue™
323537|NCT00821236|E1|Reported Event|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
323538|NCT00821184|B3|Baseline|Total|Total of all reporting groups
323539|NCT00821184|B2|Baseline|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
323540|NCT00821184|B1|Baseline|Vesicare Alone|Vesicare alone in treatment of incontinence
323541|NCT00821184|P2|Participant Flow|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
323542|NCT00821184|P1|Participant Flow|Vesicare Alone|Vesicare alone in treatment of incontinence
323543|NCT00821184|O2|Outcome|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
323544|NCT00821184|O1|Outcome|Vesicare Alone|Vesicare alone in treatment of incontinence
323545|NCT00821184|E2|Reported Event|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
323546|NCT00821184|E1|Reported Event|Vesicare Alone|Vesicare alone in treatment of incontinence
323547|NCT00821119|B3|Baseline|Total|Total of all reporting groups
323548|NCT00821119|B2|Baseline|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
323549|NCT00821119|B1|Baseline|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
323550|NCT00821119|P2|Participant Flow|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 – 6 cm H2O, inspiratory time (Ti) of 0.4 – 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
323551|NCT00821119|P1|Participant Flow|Nasal Continuous Positive Airway Pressure (NCPAP)|Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 – 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
323610|NCT00820664|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
323611|NCT00820664|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
323552|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
323553|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
323554|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
323555|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
323556|NCT00821119|O2|Outcome|NIPPV|preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
323557|NCT00821119|O1|Outcome|NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
323558|NCT00821119|E2|Reported Event|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
323559|NCT00821119|E1|Reported Event|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
323560|NCT00821093|B3|Baseline|Total|Total of all reporting groups
323561|NCT00821093|B2|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323562|NCT00821093|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323563|NCT00821093|P2|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323564|NCT00821093|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323565|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323566|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323567|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323612|NCT00820664|O3|Outcome|Placebo|
323613|NCT00820664|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
323568|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323569|NCT00821093|E2|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323570|NCT00821093|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
323571|NCT00821041|B3|Baseline|Total|Total of all reporting groups
323572|NCT00821041|B2|Baseline|Cognitive Behavioral Therapy|
323573|NCT00821041|B1|Baseline|Waiting List Control|
323574|NCT00821041|P2|Participant Flow|Cognitive Behavioral Therapy|
323575|NCT00821041|P1|Participant Flow|Waiting List Control|
323576|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
323577|NCT00821041|O1|Outcome|Waiting List Control|
323578|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
323579|NCT00821041|O1|Outcome|Waiting List Control|
323580|NCT00821041|E2|Reported Event|Cognitive Behavioral Therapy|
323581|NCT00821041|E1|Reported Event|Waiting List Control|
323582|NCT00820755|B1|Baseline|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
323583|NCT00820755|P3|Participant Flow|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323584|NCT00820755|P2|Participant Flow|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323585|NCT00820755|P1|Participant Flow|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
323586|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323587|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323588|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323589|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323614|NCT00820664|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
323615|NCT00820664|E3|Reported Event|Placebo|
323616|NCT00820664|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
323617|NCT00820664|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
323590|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
323591|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323592|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323593|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
323594|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323595|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323596|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323597|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323598|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323599|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323600|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323601|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
323602|NCT00820755|E3|Reported Event|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
323603|NCT00820755|E2|Reported Event|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
323604|NCT00820755|E1|Reported Event|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
323623|NCT00820612|O2|Outcome|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323624|NCT00820612|O1|Outcome|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323625|NCT00820612|E2|Reported Event|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323626|NCT00820612|E1|Reported Event|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
323627|NCT00820573|B5|Baseline|Total|Total of all reporting groups
323628|NCT00820573|B4|Baseline|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
323629|NCT00820573|B3|Baseline|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
323630|NCT00820573|B2|Baseline|Metformin|all subjects after receiving 6 weeks of metformin therapy
323631|NCT00820573|B1|Baseline|Placebo|all subjects after 6 weeks of placebo therapy
323632|NCT00820573|P4|Participant Flow|Sitagliptin Plus Metformin, Sitagliptin, Placebo,Metformin|Sequence as described, starting with combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily placebo therapy for 6 weeks and finally metforminfor 6 weeks.
323633|NCT00820573|P3|Participant Flow|Metformin, Sitagliptin Plus Metformin, Sitagliptin,Placebo|Sequence as described, starting with metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily followed by placebo therapy for the final 6 weeks
323634|NCT00820573|P2|Participant Flow|Sitagliptin, Metformin, Sitagliptin Plus Metformin, Placebo|Sequence as described, starting with sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks and then placebo therapy for the final 6 weeks
323635|NCT00820573|P1|Participant Flow|Placebo,Sitagliptin,Metformin and Sitagliptin Plus Metformin|Sequence as described, starting placebo therapy for 6 weeks,followed by sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks and the combination sitagliptn plus metformin for the final 6 weeks
323636|NCT00820573|O4|Outcome|Sitagliptin+Metformin|placebo for 6 weeks
323637|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
323638|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
323639|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
323640|NCT00820573|O4|Outcome|Sitagliptin + Metformin|placebo for 6 weeks
323641|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
323642|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
323643|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
323644|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
323645|NCT00820573|O3|Outcome|Sitagliptin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
323646|NCT00820573|O2|Outcome|Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
323647|NCT00820573|O1|Outcome|Placebo|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin.
323648|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
323649|NCT00820573|O3|Outcome|Sitagliptin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
323650|NCT00820573|O2|Outcome|Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
323651|NCT00820573|O1|Outcome|Placebo|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
323652|NCT00820573|E4|Reported Event|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
323653|NCT00820573|E3|Reported Event|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
323654|NCT00820573|E2|Reported Event|Metformin|all subjects after receiving 6 weeks of metformin therapy
323655|NCT00820573|E1|Reported Event|Placebo|all subjects after 6 weeks of placebo therapy
323656|NCT00820534|B3|Baseline|Total|Total of all reporting groups
323657|NCT00820534|B2|Baseline|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
323658|NCT00820534|B1|Baseline|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
323659|NCT00820534|P2|Participant Flow|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
323660|NCT00820534|P1|Participant Flow|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
323661|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
323662|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
323663|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
323664|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
323665|NCT00820534|E2|Reported Event|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
323666|NCT00820534|E1|Reported Event|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
323667|NCT00820443|B1|Baseline|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323875|NCT00819832|B3|Baseline|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
323668|NCT00820443|P1|Participant Flow|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323669|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323670|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component"
323671|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323672|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323673|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323674|NCT00820443|E1|Reported Event|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
323675|NCT00820222|B3|Baseline|Total|Total of all reporting groups
323676|NCT00820222|B2|Baseline|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323677|NCT00820222|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323678|NCT00820222|P2|Participant Flow|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323679|NCT00820222|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323680|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323681|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323682|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323683|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323684|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323685|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323715|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323686|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323687|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323688|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323689|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323690|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323691|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323692|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323693|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323694|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323695|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323696|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323697|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323698|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323699|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323876|NCT00819832|B2|Baseline|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
323700|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323701|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323702|NCT00820222|E2|Reported Event|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323703|NCT00820222|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
323704|NCT00819182|B4|Baseline|Total|Total of all reporting groups
323705|NCT00819182|B3|Baseline|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323706|NCT00819182|B2|Baseline|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323707|NCT00819182|B1|Baseline|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323708|NCT00819182|P3|Participant Flow|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323709|NCT00819182|P2|Participant Flow|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323710|NCT00819182|P1|Participant Flow|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323711|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323712|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323713|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323714|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323877|NCT00819832|B1|Baseline|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
323716|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323717|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323718|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323719|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323720|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323721|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323722|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323723|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323724|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323725|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323726|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323727|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323728|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323729|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323730|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323731|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323758|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323759|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323878|NCT00819832|P6|Participant Flow|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
323732|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323733|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323734|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323735|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323736|NCT00819182|E3|Reported Event|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
323737|NCT00819182|E2|Reported Event|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
323738|NCT00819182|E1|Reported Event|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
323739|NCT00819156|B7|Baseline|Total|Total of all reporting groups
323740|NCT00819156|B6|Baseline|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323741|NCT00819156|B5|Baseline|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323742|NCT00819156|B4|Baseline|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323743|NCT00819156|B3|Baseline|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323744|NCT00819156|B2|Baseline|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323745|NCT00819156|B1|Baseline|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323746|NCT00819156|P6|Participant Flow|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323747|NCT00819156|P5|Participant Flow|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323748|NCT00819156|P4|Participant Flow|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323749|NCT00819156|P3|Participant Flow|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323750|NCT00819156|P2|Participant Flow|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323751|NCT00819156|P1|Participant Flow|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323752|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323753|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323754|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323755|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323756|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323757|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
324971|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
323760|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323761|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323762|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323763|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323764|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323765|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323766|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323767|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323768|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323769|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323770|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323771|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323772|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323773|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323774|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323775|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323776|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323777|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323778|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323779|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323780|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323781|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323782|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323783|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323784|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323785|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323786|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323787|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323788|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323789|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323790|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323791|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323792|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323793|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323794|NCT00819156|O5|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323795|NCT00819156|O4|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323796|NCT00819156|O3|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323797|NCT00819156|O2|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323798|NCT00819156|O1|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323799|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323800|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323801|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323802|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323803|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323804|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323805|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323806|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323807|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323808|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323809|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323810|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323811|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323812|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323813|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323814|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323815|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323816|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323817|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323818|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323819|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323820|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323821|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323822|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323823|NCT00819156|O3|Outcome|Maintenance Dose of 160 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
323824|NCT00819156|O2|Outcome|Maintenance Dose of 120 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
323825|NCT00819156|O1|Outcome|Maintenance Dose of 80 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
323826|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323827|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323828|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323829|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323830|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323831|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323832|NCT00819156|E6|Reported Event|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323833|NCT00819156|E5|Reported Event|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323834|NCT00819156|E4|Reported Event|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323835|NCT00819156|E3|Reported Event|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
323836|NCT00819156|E2|Reported Event|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
323837|NCT00819156|E1|Reported Event|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
323838|NCT00819910|B5|Baseline|Total|Total of all reporting groups
323839|NCT00819910|B4|Baseline|Placebo Therapy Daily|Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
323840|NCT00819910|B3|Baseline|Rosiglitazone + Placebo|Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
323841|NCT00819910|B2|Baseline|Fenofibrate + Placebo|Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
323842|NCT00819910|B1|Baseline|Rosiglitazone/Fenofibrate Therapy Daily|Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
323843|NCT00819910|P4|Participant Flow|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323844|NCT00819910|P3|Participant Flow|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323845|NCT00819910|P2|Participant Flow|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323846|NCT00819910|P1|Participant Flow|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323847|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323848|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323849|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323850|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323851|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323852|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323853|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323854|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323855|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323856|NCT00819910|O3|Outcome|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323857|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323858|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323859|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323860|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323861|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323862|NCT00819910|O1|Outcome|Rosiglitazone and Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323863|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323864|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
323865|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
323866|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
323867|NCT00819910|E4|Reported Event|Placebo Therapy Daily|"Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
323868|NCT00819910|E3|Reported Event|Fenofibrate + Placebo|"Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
323869|NCT00819910|E2|Reported Event|Rosiglitazone + Placebo|"Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
323870|NCT00819910|E1|Reported Event|Rosiglitazone/Fenofibrate Therapy Daily|"Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
323871|NCT00819832|B7|Baseline|Total|Total of all reporting groups
323872|NCT00819832|B6|Baseline|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
323873|NCT00819832|B5|Baseline|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
323874|NCT00819832|B4|Baseline|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
323879|NCT00819832|P5|Participant Flow|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
323880|NCT00819832|P4|Participant Flow|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
323881|NCT00819832|P3|Participant Flow|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
323882|NCT00819832|P2|Participant Flow|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
323883|NCT00819832|P1|Participant Flow|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
323884|NCT00819832|O6|Outcome|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
323885|NCT00819832|O5|Outcome|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
323886|NCT00819832|O4|Outcome|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
323887|NCT00819832|O3|Outcome|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
323888|NCT00819832|O2|Outcome|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
323889|NCT00819832|O1|Outcome|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
323890|NCT00819832|E6|Reported Event|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
323891|NCT00819832|E5|Reported Event|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
323892|NCT00819832|E4|Reported Event|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
323893|NCT00819832|E3|Reported Event|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
323894|NCT00819832|E2|Reported Event|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
323895|NCT00819832|E1|Reported Event|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
323896|NCT00819780|B3|Baseline|Total|Total of all reporting groups
323897|NCT00819780|B2|Baseline|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323898|NCT00819780|B1|Baseline|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323899|NCT00819780|P2|Participant Flow|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
323900|NCT00819780|P1|Participant Flow|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
323901|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323902|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323903|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323904|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323905|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323906|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323907|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323908|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323909|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323910|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323911|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323912|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323913|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323914|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323915|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323916|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323917|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323918|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323919|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
324229|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
323920|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323921|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323922|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323923|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323924|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323925|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323926|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323927|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323928|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323929|NCT00819780|E2|Reported Event|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323930|NCT00819780|E1|Reported Event|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
323931|NCT00819767|B3|Baseline|Total|Total of all reporting groups
323932|NCT00819767|B2|Baseline|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323933|NCT00819767|B1|Baseline|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323934|NCT00819767|P2|Participant Flow|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323935|NCT00819767|P1|Participant Flow|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323936|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323937|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323938|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323939|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323960|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323940|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323941|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323942|NCT00819767|E2|Reported Event|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323943|NCT00819767|E1|Reported Event|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
323944|NCT00819741|B3|Baseline|Total|Total of all reporting groups
323945|NCT00819741|B2|Baseline|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323946|NCT00819741|B1|Baseline|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323947|NCT00819741|P2|Participant Flow|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323948|NCT00819741|P1|Participant Flow|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323949|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323950|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323951|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323952|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323953|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323954|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323955|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323956|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323957|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323958|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323959|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323961|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323962|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323963|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323964|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323965|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323966|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323967|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323968|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323969|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323970|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323971|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323972|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323973|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323974|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323975|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323976|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323977|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323978|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323979|NCT00819741|E2|Reported Event|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
323980|NCT00819741|E1|Reported Event|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
323981|NCT00819637|B4|Baseline|Total|Total of all reporting groups
323982|NCT00819637|B3|Baseline|Levalbuterol 3 Doses|
323983|NCT00819637|B2|Baseline|Arformoterol 3 Doses|
323984|NCT00819637|B1|Baseline|Arformoterol 1 Dose, Placebo 2 Doses|
323985|NCT00819637|P3|Participant Flow|Levalbuterol 3 Doses|
323986|NCT00819637|P2|Participant Flow|Arformoterol 3 Doses|
323987|NCT00819637|P1|Participant Flow|Arformoterol 1 Dose, Placebo 2 Doses|
323995|NCT00819585|B7|Baseline|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
323996|NCT00819585|B6|Baseline|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
323997|NCT00819585|B5|Baseline|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
323998|NCT00819585|B4|Baseline|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
323999|NCT00819585|B3|Baseline|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324000|NCT00819585|B2|Baseline|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324001|NCT00819585|B1|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324002|NCT00819585|P7|Participant Flow|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324003|NCT00819585|P6|Participant Flow|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324004|NCT00819585|P5|Participant Flow|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324005|NCT00819585|P4|Participant Flow|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324006|NCT00819585|P3|Participant Flow|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324007|NCT00819585|P2|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324008|NCT00819585|P1|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324009|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324010|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324230|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324011|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324012|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324013|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324014|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324015|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324016|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324017|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324018|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324019|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324020|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324021|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324022|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324023|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324024|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324025|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324026|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324221|NCT00819247|P1|Participant Flow|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324439|NCT00819091|E1|Reported Event|Placebo|Matching placebo tablet taken orally once daily
324027|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324028|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324029|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324030|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324031|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324032|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324033|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324034|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324035|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324036|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324037|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324038|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324039|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324040|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324041|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324042|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324222|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324440|NCT00819052|B3|Baseline|Total|Total of all reporting groups
324043|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324044|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324045|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324046|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324047|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324048|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324049|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324050|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324051|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324052|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324053|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324054|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324055|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324056|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324057|NCT00819585|E7|Reported Event|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324058|NCT00819585|E6|Reported Event|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324223|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324059|NCT00819585|E5|Reported Event|Canakinumab 300mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
324060|NCT00819585|E4|Reported Event|Canakinumab 200mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324061|NCT00819585|E3|Reported Event|Canakinumab 100mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324062|NCT00819585|E2|Reported Event|Canakinumab 50mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324063|NCT00819585|E1|Reported Event|Canakinumab 25mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
324064|NCT00819403|B3|Baseline|Total|Total of all reporting groups
324065|NCT00819403|B2|Baseline|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
324066|NCT00819403|B1|Baseline|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
324067|NCT00819403|P2|Participant Flow|Simvastatin/Ezetimibe Then Simvastatin|Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
324068|NCT00819403|P1|Participant Flow|Simvastatin Then Simvastatin/Ezetimibe|"Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily~Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied."
324069|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
324070|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
324071|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
324072|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
324073|NCT00819403|E2|Reported Event|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
324074|NCT00819403|E1|Reported Event|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
324075|NCT00819390|B5|Baseline|Total|Total of all reporting groups
324076|NCT00819390|B4|Baseline|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324077|NCT00819390|B3|Baseline|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324078|NCT00819390|B2|Baseline|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324079|NCT00819390|B1|Baseline|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324080|NCT00819390|P4|Participant Flow|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324081|NCT00819390|P3|Participant Flow|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324082|NCT00819390|P2|Participant Flow|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324083|NCT00819390|P1|Participant Flow|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324084|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324085|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324086|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324087|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324088|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324089|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324090|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324091|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324092|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324093|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324094|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324095|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324096|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324097|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324098|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324099|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324100|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324101|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324102|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324224|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324103|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324104|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324105|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324106|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324107|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324108|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324109|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324110|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324111|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324112|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324113|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324114|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324115|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324116|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324117|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324118|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324119|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324120|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324121|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324122|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324225|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324123|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324124|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324125|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324126|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324127|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324128|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324129|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324130|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324131|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324132|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324133|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324134|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324135|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324136|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324137|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324138|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324139|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324140|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324141|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324142|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324226|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324143|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324144|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324145|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324146|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324147|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324148|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324149|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324150|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324151|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324152|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324153|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324154|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324155|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324156|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324157|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324158|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324159|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324160|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324161|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324162|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324227|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324163|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324164|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324165|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324166|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324167|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324168|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324169|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324170|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324171|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324172|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324173|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324174|NCT00819390|O2|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324175|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324176|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324177|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324178|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324179|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324180|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324181|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324182|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324228|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324183|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324184|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324185|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324186|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324187|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324188|NCT00819390|E4|Reported Event|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324189|NCT00819390|E3|Reported Event|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324190|NCT00819390|E2|Reported Event|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324191|NCT00819390|E1|Reported Event|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
324192|NCT00819286|B3|Baseline|Total|Total of all reporting groups
324193|NCT00819286|B2|Baseline|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
324194|NCT00819286|B1|Baseline|Wire (Control)|patients will have their sternum closed using stainless steel wires.
324195|NCT00819286|P2|Participant Flow|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
324196|NCT00819286|P1|Participant Flow|Wire (Control)|patients will have their sternum closed using stainless steel wires.
324197|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
324198|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
324199|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
324200|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
324201|NCT00819286|E2|Reported Event|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
324202|NCT00819286|E1|Reported Event|Wire (Control)|patients will have their sternum closed using stainless steel wires.
324203|NCT00819260|B1|Baseline|All Participants|Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
324204|NCT00819260|P1|Participant Flow|All Participants|All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
324205|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
324206|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
324207|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
324208|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
324209|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
324210|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
324211|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
324212|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
324213|NCT00819260|E2|Reported Event|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
324214|NCT00819260|E1|Reported Event|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
324215|NCT00819247|B4|Baseline|Total|Total of all reporting groups
324216|NCT00819247|B3|Baseline|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324217|NCT00819247|B2|Baseline|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324218|NCT00819247|B1|Baseline|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324219|NCT00819247|P3|Participant Flow|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324220|NCT00819247|P2|Participant Flow|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324231|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324232|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324233|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324234|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324235|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324236|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324237|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324238|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324239|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324240|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324241|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324242|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324243|NCT00819247|E3|Reported Event|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
324244|NCT00819247|E2|Reported Event|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324245|NCT00819247|E1|Reported Event|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
324246|NCT00819234|B1|Baseline|All Participants|All participants who completed the original study and chose to enter the extension study.
324247|NCT00819234|P10|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324248|NCT00819234|P9|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324249|NCT00819234|P8|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324250|NCT00819234|P7|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
324251|NCT00819234|P6|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
324252|NCT00819234|P5|Participant Flow|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
324253|NCT00819234|P4|Participant Flow|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324254|NCT00819234|P3|Participant Flow|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324255|NCT00819234|P2|Participant Flow|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324256|NCT00819234|P1|Participant Flow|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324257|NCT00819234|O6|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324441|NCT00819052|B2|Baseline|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324258|NCT00819234|O5|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324259|NCT00819234|O4|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324260|NCT00819234|O3|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324261|NCT00819234|O2|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324262|NCT00819234|O1|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324263|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324264|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324265|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324266|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324267|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324268|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324269|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324270|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324271|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324272|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324273|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324274|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324275|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324972|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324276|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324277|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324278|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324279|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324280|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324281|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324282|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324283|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324284|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324285|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324286|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324287|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324288|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324289|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324290|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324291|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324292|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324293|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324294|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324295|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324296|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324297|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324298|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324299|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324300|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324301|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324302|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324303|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324304|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324305|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324306|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324307|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324308|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324309|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324310|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324311|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324312|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324313|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324314|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324973|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324315|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324316|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324317|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324318|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324319|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324320|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324321|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324322|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324323|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324324|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324325|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324326|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324327|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324328|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324329|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324330|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324331|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324332|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324333|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324334|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324335|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324336|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324337|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324338|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324339|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324340|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324341|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324342|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324343|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324344|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324345|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324346|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324347|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324348|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324349|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324350|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324442|NCT00819052|B1|Baseline|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324974|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324351|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324352|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324353|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324354|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324355|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324356|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324357|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324358|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324359|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324360|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324361|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324362|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324363|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324364|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324365|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324366|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324367|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324368|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
324400|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
324369|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324370|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324371|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324372|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324373|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324374|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324375|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324376|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324377|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324378|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324379|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324380|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324381|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324382|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324383|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324384|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324385|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324386|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324387|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324388|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324389|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324390|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
324391|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
324392|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
324393|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
324394|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
324395|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
324396|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
324397|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
324398|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324399|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
324401|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
324402|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324403|NCT00819234|E10|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324404|NCT00819234|E9|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324405|NCT00819234|E8|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
324406|NCT00819234|E7|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324407|NCT00819234|E6|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324408|NCT00819234|E5|Reported Event|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
324409|NCT00819234|E4|Reported Event|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324410|NCT00819234|E3|Reported Event|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324411|NCT00819234|E2|Reported Event|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
324412|NCT00819234|E1|Reported Event|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
324413|NCT00819091|B3|Baseline|Total|Total of all reporting groups
324414|NCT00819091|B2|Baseline|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324415|NCT00819091|B1|Baseline|Placebo|Matching placebo tablet taken orally once daily
324416|NCT00819091|P2|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324417|NCT00819091|P1|Participant Flow|Placebo|Matching placebo tablet taken orally once daily
324418|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324419|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324420|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324421|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324422|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324423|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324424|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324425|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324426|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324427|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324428|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324429|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324430|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324431|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324432|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324433|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324434|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324435|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324436|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324437|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
324438|NCT00819091|E2|Reported Event|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
324443|NCT00819052|P2|Participant Flow|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324444|NCT00819052|P1|Participant Flow|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324445|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324446|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324447|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324448|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324449|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324450|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324451|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324452|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324453|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324454|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324455|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324456|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324457|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324458|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324459|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324460|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324461|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324462|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324463|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324464|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324465|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324466|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324467|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324468|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324469|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324470|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324471|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324472|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324473|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324474|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324475|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324476|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324477|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324478|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324479|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324480|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324481|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324482|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324483|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324484|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324485|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324486|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324487|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324488|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324489|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324490|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324491|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324492|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324493|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324494|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324495|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324496|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324497|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324498|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324499|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324500|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324975|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324501|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324502|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324503|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324504|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324505|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324506|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324507|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324508|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324509|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324510|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324511|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324512|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324513|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324514|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324515|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324516|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324517|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324518|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324519|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324520|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324521|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324522|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
324523|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
324524|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
324525|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324526|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324527|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324528|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324529|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324530|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324531|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324532|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324533|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324534|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324535|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324536|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324537|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324538|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324539|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324540|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324541|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324542|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324543|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324544|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324545|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324546|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324547|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324548|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324549|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324550|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324551|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324552|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324553|NCT00819052|E2|Reported Event|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
324554|NCT00819052|E1|Reported Event|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
324555|NCT00819039|B4|Baseline|Total|Total of all reporting groups
324587|NCT00819013|B4|Baseline|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324556|NCT00819039|B3|Baseline|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324557|NCT00819039|B2|Baseline|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324558|NCT00819039|B1|Baseline|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324559|NCT00819039|P3|Participant Flow|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324560|NCT00819039|P2|Participant Flow|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324561|NCT00819039|P1|Participant Flow|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324562|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324563|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
324564|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324565|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
324566|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324567|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
324568|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324569|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
324570|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324571|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
324572|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324573|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324574|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324575|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324576|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324577|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324578|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324579|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324580|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324581|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324582|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324583|NCT00819039|E3|Reported Event|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324584|NCT00819039|E2|Reported Event|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324585|NCT00819039|E1|Reported Event|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
324586|NCT00819013|B5|Baseline|Total|Total of all reporting groups
324588|NCT00819013|B3|Baseline|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324589|NCT00819013|B2|Baseline|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324590|NCT00819013|B1|Baseline|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324591|NCT00819013|P4|Participant Flow|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324592|NCT00819013|P3|Participant Flow|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324593|NCT00819013|P2|Participant Flow|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324594|NCT00819013|P1|Participant Flow|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324595|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324596|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324597|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324598|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324599|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324600|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324601|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324602|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324603|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324604|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324605|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324606|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324607|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324608|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324609|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324610|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324611|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324612|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324613|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324614|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324615|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324616|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324617|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324618|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324619|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324620|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324621|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324622|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324623|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324624|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324625|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324626|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324627|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324628|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324710|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
324629|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324630|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324631|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324632|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324633|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324634|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324635|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324636|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324637|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324638|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324639|NCT00819013|E4|Reported Event|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
324640|NCT00819013|E3|Reported Event|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
324641|NCT00819013|E2|Reported Event|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
324642|NCT00819013|E1|Reported Event|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
324643|NCT00818961|B1|Baseline|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324644|NCT00818961|P1|Participant Flow|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324645|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324646|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324647|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324648|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324649|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324650|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324651|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324652|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324653|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324654|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324655|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
324656|NCT00818961|E1|Reported Event|Hematopoietic Stem Cell Transplantation|All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
324657|NCT00818883|B3|Baseline|Total|Total of all reporting groups
324658|NCT00818883|B2|Baseline|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324659|NCT00818883|B1|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324660|NCT00818883|P2|Participant Flow|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324661|NCT00818883|P1|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324662|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324663|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324664|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324665|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324666|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324667|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324668|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324669|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324670|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324671|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324672|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324673|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324674|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324675|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324676|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324677|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324678|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324679|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324680|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324711|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
324712|NCT00818779|E2|Reported Event|Amlodipine|5-10 mg amlodipine once daily
324713|NCT00818779|E1|Reported Event|Aliskiren|Aliskiren 150-300 mg once daily
324681|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324682|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324683|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324684|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324685|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324686|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324687|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324688|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324689|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324690|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324691|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324692|NCT00818883|E2|Reported Event|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
324693|NCT00818883|E1|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
324694|NCT00818805|B1|Baseline|Entire Study Population|
324695|NCT00818805|P2|Participant Flow|Tranilast 0.5% First, Then Olopatadine Second|Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
324696|NCT00818805|P1|Participant Flow|Olopatadine 0.1% First, Then Tranilast Second|Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
324697|NCT00818805|O4|Outcome|Placebo (Tranilast)|Placebo (Tranilast) in one eye in either the first or second period
324698|NCT00818805|O3|Outcome|Placebo (Olopatadine)|Placebo (Olopatadine) in one eye in either the first or second period
324699|NCT00818805|O2|Outcome|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
324700|NCT00818805|O1|Outcome|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
324701|NCT00818805|E4|Reported Event|Placebo (Tranilast) One Eye|Placebo (Tranilast) in one eye in either the first or second period
324702|NCT00818805|E3|Reported Event|Placebo (Olopatadine) One Eye|Placebo (Olopatadine) in one eye in either the first or second period
324703|NCT00818805|E2|Reported Event|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
324704|NCT00818805|E1|Reported Event|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
324705|NCT00818779|B3|Baseline|Total|Total of all reporting groups
324706|NCT00818779|B2|Baseline|Amlodipine|5-10 mg amlodipine once daily
324707|NCT00818779|B1|Baseline|Aliskiren|Aliskiren 150-300 mg once daily
324708|NCT00818779|P2|Participant Flow|Amlodipine|5-10 mg amlodipine once daily
324709|NCT00818779|P1|Participant Flow|Aliskiren|Aliskiren 150-300 mg once daily
324715|NCT00818753|B3|Baseline|Heparin|Unfractionated heparin administered during intervention
324716|NCT00818753|B2|Baseline|Dabigatran 150mg Bis in Die (BID)|
324717|NCT00818753|B1|Baseline|Dabigatran 110mg Bis in Die (BID)|
324718|NCT00818753|P3|Participant Flow|Heparin|Unfractionated heparin administered during intervention
324719|NCT00818753|P2|Participant Flow|Dabigatran 150mg Bis in Die (BID)|
324720|NCT00818753|P1|Participant Flow|Dabigatran 110mg Bis in Die (BID)|
324721|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
324722|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
324723|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
324724|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
324725|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
324726|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
324727|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
324728|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
324729|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
324730|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
324731|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
324732|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
324733|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
324734|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
324735|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
324736|NCT00818753|E3|Reported Event|Heparin|Unfractionated heparin administered during intervention
324737|NCT00818753|E2|Reported Event|Dabigatran 150mg Bis in Die (BID)|
324738|NCT00818753|E1|Reported Event|Dabigatran 110mg Bis in Die (BID)|
324739|NCT00818662|B5|Baseline|Total|Total of all reporting groups
324740|NCT00818662|B4|Baseline|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
324741|NCT00818662|B3|Baseline|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
324742|NCT00818662|B2|Baseline|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324743|NCT00818662|B1|Baseline|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324744|NCT00818662|P4|Participant Flow|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
324745|NCT00818662|P3|Participant Flow|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
324746|NCT00818662|P2|Participant Flow|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324747|NCT00818662|P1|Participant Flow|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324748|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324749|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324750|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324751|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324752|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324753|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324754|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324755|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324756|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324757|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324758|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324759|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324760|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324761|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324762|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324763|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324764|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324765|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324766|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324767|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324768|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324769|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324770|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324771|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324772|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324773|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324774|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324775|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324776|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324777|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324778|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324779|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324780|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324781|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324782|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324783|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324784|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324785|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324786|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324787|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324788|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324789|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324790|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324791|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324792|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324793|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324794|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324795|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324796|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324797|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324798|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324799|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324800|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324801|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324802|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324803|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324804|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324805|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324806|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324807|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324808|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324809|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324810|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324811|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324812|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324813|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324814|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324815|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324816|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324817|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324818|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324819|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324820|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324821|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324865|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324866|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324822|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324823|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
324824|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
324825|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
324826|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324827|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324828|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324829|NCT00818662|E3|Reported Event|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324830|NCT00818662|E2|Reported Event|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324831|NCT00818662|E1|Reported Event|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
324832|NCT00818649|B1|Baseline|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
324833|NCT00818649|P1|Participant Flow|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
324834|NCT00818649|O1|Outcome|Evaluable Patients|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment continued for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
324835|NCT00818649|E1|Reported Event|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
324836|NCT00818623|B9|Baseline|Total|Total of all reporting groups
324837|NCT00818623|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324838|NCT00818623|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324839|NCT00818623|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324840|NCT00818623|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324841|NCT00818623|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324842|NCT00818623|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324843|NCT00818623|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324844|NCT00818623|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324845|NCT00818623|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324846|NCT00818623|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324847|NCT00818623|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324848|NCT00818623|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324849|NCT00818623|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324850|NCT00818623|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324851|NCT00818623|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324852|NCT00818623|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324853|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324854|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324855|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324856|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324857|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324858|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324859|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324860|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324861|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324862|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324863|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324864|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324867|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324868|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324869|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324870|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324871|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324872|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324873|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324874|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324875|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324876|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324877|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324878|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324879|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324880|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324881|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324882|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324883|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324884|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324885|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324886|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324887|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324888|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324889|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324890|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324891|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324892|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324893|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324894|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324895|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324896|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324897|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324898|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324899|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324900|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324901|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324902|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324903|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324904|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324905|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324906|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324907|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324908|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324909|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324910|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324911|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324912|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324913|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324914|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324915|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324916|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324917|NCT00818623|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
324918|NCT00818623|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
324919|NCT00818623|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
324920|NCT00818623|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
324921|NCT00818623|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
324922|NCT00818623|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
324923|NCT00818623|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
324924|NCT00818623|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
324925|NCT00818519|B3|Baseline|Total|Total of all reporting groups
324926|NCT00818519|B2|Baseline|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324927|NCT00818519|B1|Baseline|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324928|NCT00818519|P2|Participant Flow|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324929|NCT00818519|P1|Participant Flow|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324930|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324967|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324931|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324932|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324933|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324934|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324935|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324936|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324937|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324938|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324939|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324940|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324941|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324942|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324943|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324944|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324945|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324946|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324947|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324948|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324949|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324950|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324951|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324952|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324953|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324954|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324955|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324956|NCT00818519|E2|Reported Event|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
324957|NCT00818519|E1|Reported Event|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
324958|NCT00818454|B1|Baseline|Entire Study Population|Participants randomized to crossover part at randomization 1
324959|NCT00818454|P4|Participant Flow|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
324960|NCT00818454|P3|Participant Flow|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
324961|NCT00818454|P2|Participant Flow|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
324962|NCT00818454|P1|Participant Flow|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
324963|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
324964|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
324965|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
324966|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
324976|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324977|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324978|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324979|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324980|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324981|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
324982|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
324983|NCT00818454|E4|Reported Event|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
324984|NCT00818454|E3|Reported Event|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
324985|NCT00818454|E2|Reported Event|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
324986|NCT00818454|E1|Reported Event|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
324987|NCT00818441|B3|Baseline|Total|Total of all reporting groups
324988|NCT00818441|B2|Baseline|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324989|NCT00818441|B1|Baseline|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
324990|NCT00818441|P2|Participant Flow|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324991|NCT00818441|P1|Participant Flow|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
324992|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324993|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325011|NCT00818389|B2|Baseline|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325181|NCT00817804|B3|Baseline|Total|Total of all reporting groups
324994|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324995|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
324996|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324997|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
324998|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
324999|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325000|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
325001|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325029|NCT00818324|P1|Participant Flow|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
325002|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
325003|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325004|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
325005|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325006|NCT00818441|O1|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
325007|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325008|NCT00818441|E2|Reported Event|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
325009|NCT00818441|E1|Reported Event|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
325010|NCT00818389|B3|Baseline|Total|Total of all reporting groups
325306|NCT00816829|O1|Outcome|Placebo|Placebo
325012|NCT00818389|B1|Baseline|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325013|NCT00818389|P2|Participant Flow|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325014|NCT00818389|P1|Participant Flow|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325015|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325016|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325017|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325018|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325019|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325020|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325021|NCT00818389|E2|Reported Event|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
325022|NCT00818389|E1|Reported Event|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
325023|NCT00818337|B1|Baseline|Aspirin 81mg|Aspirin 81mg at baseline
325024|NCT00818337|P1|Participant Flow|Aspirin 81mg|Aspirin 81mg at baseline
325025|NCT00818337|O1|Outcome|Aspirin 325 mg|Participants who were aspirin resistant who were increased to aspirin 325 mg
325026|NCT00818337|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg at baseline
325027|NCT00818337|E1|Reported Event|Aspirin 81mg|Aspirin 81mg at baseline
325028|NCT00818324|B1|Baseline|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
325307|NCT00816829|E2|Reported Event|Fenofibrate|Fenofibrate 145 mg
325030|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
325031|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
325032|NCT00818324|E1|Reported Event|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
325033|NCT00818272|B1|Baseline|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325034|NCT00818272|P1|Participant Flow|Infliximab|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325035|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325036|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325037|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325038|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325039|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325040|NCT00818272|E1|Reported Event|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
325041|NCT00818259|B8|Baseline|Total|Total of all reporting groups
325042|NCT00818259|B7|Baseline|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325043|NCT00818259|B6|Baseline|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325044|NCT00818259|B5|Baseline|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325045|NCT00818259|B4|Baseline|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325064|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325046|NCT00818259|B3|Baseline|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325047|NCT00818259|B2|Baseline|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325048|NCT00818259|B1|Baseline|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325049|NCT00818259|P9|Participant Flow|Part V-Additional Enrollers|Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325050|NCT00818259|P8|Participant Flow|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325051|NCT00818259|P7|Participant Flow|Part IV-Additional Enrollers|Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325052|NCT00818259|P6|Participant Flow|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325053|NCT00818259|P5|Participant Flow|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325054|NCT00818259|P4|Participant Flow|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325055|NCT00818259|P3|Participant Flow|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325056|NCT00818259|P2|Participant Flow|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325057|NCT00818259|P1|Participant Flow|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325058|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325059|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325060|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325061|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325062|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325063|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325308|NCT00816829|E1|Reported Event|Placebo|Placebo
325065|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325066|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325067|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325068|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325069|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325070|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325071|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325072|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325073|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325074|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325075|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325076|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325077|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325078|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325079|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325080|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325081|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325082|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325102|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325083|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325084|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325085|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325086|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325087|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325088|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325089|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325090|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325091|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325092|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325093|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325094|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325095|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325096|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325097|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325098|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325099|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325100|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325101|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325103|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325104|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325105|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325106|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325107|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325108|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325109|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325110|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325111|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325112|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325113|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325114|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325115|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325116|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325117|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325118|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325119|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325120|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325121|NCT00818259|E7|Reported Event|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325180|NCT00817843|E1|Reported Event|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
325122|NCT00818259|E6|Reported Event|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
325123|NCT00818259|E5|Reported Event|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
325124|NCT00818259|E4|Reported Event|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325125|NCT00818259|E3|Reported Event|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325126|NCT00818259|E2|Reported Event|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325127|NCT00818259|E1|Reported Event|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
325128|NCT00818246|B1|Baseline|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325129|NCT00818246|P1|Participant Flow|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325130|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325131|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325132|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325133|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325134|NCT00818246|E1|Reported Event|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
325135|NCT00818207|B3|Baseline|Total|Total of all reporting groups
325136|NCT00818207|B2|Baseline|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325137|NCT00818207|B1|Baseline|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325138|NCT00818207|P2|Participant Flow|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325139|NCT00818207|P1|Participant Flow|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325140|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325141|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325142|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325143|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325144|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325145|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325146|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325147|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325148|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325149|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325150|NCT00818207|E2|Reported Event|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
325151|NCT00818207|E1|Reported Event|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
325152|NCT00818168|B1|Baseline|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325153|NCT00818168|P1|Participant Flow|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325154|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325155|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325156|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325157|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325158|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325159|NCT00818168|E1|Reported Event|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
325160|NCT00818116|B1|Baseline|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
325161|NCT00818116|P1|Participant Flow|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
325162|NCT00818116|O1|Outcome|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
325163|NCT00818116|E1|Reported Event|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
325164|NCT00817999|B3|Baseline|Total|Total of all reporting groups
325165|NCT00817999|B2|Baseline|Maintenance Dose|
325166|NCT00817999|B1|Baseline|Loading Dose|
325167|NCT00817999|P2|Participant Flow|Maintenance Dose|Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
325168|NCT00817999|P1|Participant Flow|Loading Dose|Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
325169|NCT00817999|O4|Outcome|Maintenance Dose Without Grapefruit Juice|
325170|NCT00817999|O3|Outcome|Loading Dose Without Grapefruit Juice|
325171|NCT00817999|O2|Outcome|Maintenance Dose With Grapefruit Juice|
325172|NCT00817999|O1|Outcome|Loading Dose With Grapefruit Juice|
325173|NCT00817999|E2|Reported Event|Maintenance Dose|
325174|NCT00817999|E1|Reported Event|Loading Dose|
325175|NCT00817843|B1|Baseline|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
325176|NCT00817843|P2|Participant Flow|Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg|First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
325177|NCT00817843|P1|Participant Flow|Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg|First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo
325178|NCT00817843|O2|Outcome|Simvastatin 10 mg / Ezetimibe 10 mg|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
325179|NCT00817843|O1|Outcome|Simvastatin 80 mg|6 weeks of treatment with simvastatin 80 mg
325182|NCT00817804|B2|Baseline|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
325183|NCT00817804|B1|Baseline|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
325184|NCT00817804|P2|Participant Flow|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
325185|NCT00817804|P1|Participant Flow|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
325186|NCT00817804|O2|Outcome|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
325187|NCT00817804|O1|Outcome|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
325188|NCT00817804|E2|Reported Event|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
325189|NCT00817804|E1|Reported Event|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
325190|NCT00817778|B3|Baseline|Total|Total of all reporting groups
325191|NCT00817778|B2|Baseline|Placebo Comparator|Placebo
325192|NCT00817778|B1|Baseline|Experimental|AZD1656
325193|NCT00817778|P2|Participant Flow|Placebo Comparator|Placebo
325194|NCT00817778|P1|Participant Flow|Experimental|AZD1656
325195|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325196|NCT00817778|O1|Outcome|Experimental|AZD1656
325197|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325198|NCT00817778|O1|Outcome|Experimental|AZD1656
325199|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325200|NCT00817778|O1|Outcome|Experimental|AZD1656
325201|NCT00817778|O1|Outcome|Experimental|AZD1656
325202|NCT00817778|O1|Outcome|Experimental|AZD1656
325203|NCT00817778|O1|Outcome|Experimental|AZD1656
325204|NCT00817778|O1|Outcome|Experimental|AZD1656
325205|NCT00817778|O1|Outcome|Experimental|AZD1656
325206|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325207|NCT00817778|O1|Outcome|Experimental|AZD1656
325208|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325209|NCT00817778|O1|Outcome|Experimental|AZD1656
325210|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325211|NCT00817778|O1|Outcome|Experimental|AZD1656
325212|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325213|NCT00817778|O1|Outcome|Experimental|AZD1656
325214|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
325215|NCT00817778|O1|Outcome|Experimental|AZD1656
325216|NCT00817778|E2|Reported Event|Placebo Comparator|Placebo
325217|NCT00817778|E1|Reported Event|Experimental|AZD1656
325218|NCT00817596|B1|Baseline|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
325219|NCT00817596|P1|Participant Flow|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
325220|NCT00817596|O1|Outcome|Group 1|Prometra Intrathecal Pump System
325221|NCT00817596|E1|Reported Event|Group 1|Prometra Intrathecal Pump System
325222|NCT00817531|B1|Baseline|Dasatinib|Patients took Dasatinib 100mg daily
325223|NCT00817531|P1|Participant Flow|Dasatinib|Patients took Dasatinib 100mg daily
325224|NCT00817531|O1|Outcome|Dasatinib|Dasatinib 100 mg once daily
325225|NCT00817531|E1|Reported Event|Dasatinib|Patients took Dasatinib 100mg daily
325226|NCT00817479|B3|Baseline|Total|Total of all reporting groups
325227|NCT00817479|B2|Baseline|Dexamethasone|20 mg dexamethasone IV push
325228|NCT00817479|B1|Baseline|Placebo|Placebo [saline]
325229|NCT00817479|P2|Participant Flow|Dexamethasone|20 mg dexamethasone IV push
325230|NCT00817479|P1|Participant Flow|Placebo|Placebo [saline]
325231|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
325232|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
325233|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
325234|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
325235|NCT00817479|E2|Reported Event|Dexamethasone|20 mg dexamethasone IV push
325236|NCT00817479|E1|Reported Event|Placebo|Placebo [saline]
325237|NCT00817219|B1|Baseline|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325238|NCT00817219|P1|Participant Flow|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325239|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325240|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325241|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325242|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325243|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325244|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325245|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325246|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325309|NCT00816777|B3|Baseline|Total|Total of all reporting groups
326136|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
325247|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325248|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325249|NCT00817219|E1|Reported Event|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
325250|NCT00817206|B3|Baseline|Total|Total of all reporting groups
325251|NCT00817206|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
325252|NCT00817206|B1|Baseline|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
325253|NCT00817206|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
325254|NCT00817206|P1|Participant Flow|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
325255|NCT00817206|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
325256|NCT00817206|O1|Outcome|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
325257|NCT00817206|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
325258|NCT00817206|E1|Reported Event|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
325259|NCT00816907|B3|Baseline|Total|Total of all reporting groups
325260|NCT00816907|B2|Baseline|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
325261|NCT00816907|B1|Baseline|Placebo|Matching over-encapsulated placebo pills
325262|NCT00816907|P2|Participant Flow|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
325263|NCT00816907|P1|Participant Flow|Placebo|Matching over-encapsulated placebo pills
325264|NCT00816907|O2|Outcome|Metformin|
325265|NCT00816907|O1|Outcome|Placebo|
325266|NCT00816907|O2|Outcome|Metformin|
325267|NCT00816907|O1|Outcome|Placebo|
325268|NCT00816907|O2|Outcome|Metformin|
325269|NCT00816907|O1|Outcome|Placebo|
325270|NCT00816907|O2|Outcome|Metformin|
325271|NCT00816907|O1|Outcome|Placebo|
325272|NCT00816907|O2|Outcome|Metformin|
325273|NCT00816907|O1|Outcome|Placebo|
325274|NCT00816907|O2|Outcome|Metformin|
325275|NCT00816907|O1|Outcome|Placebo|
325276|NCT00816907|O2|Outcome|Metformin|
325277|NCT00816907|O1|Outcome|Placebo|
325278|NCT00816907|O2|Outcome|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
325279|NCT00816907|O1|Outcome|Placebo|Matching over-encapsulated placebo pills
325280|NCT00816907|E2|Reported Event|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
325281|NCT00816907|E1|Reported Event|Placebo|Matching over-encapsulated placebo pills
325282|NCT00816829|B3|Baseline|Total|Total of all reporting groups
325283|NCT00816829|B2|Baseline|Fenofibrate|Fenofibrate 145 mg
325284|NCT00816829|B1|Baseline|Placebo|Placebo
325285|NCT00816829|P2|Participant Flow|Fenofibrate|Fenofibrate 145 mg
325286|NCT00816829|P1|Participant Flow|Placebo|Placebo
325287|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325288|NCT00816829|O1|Outcome|Placebo|Placebo
325289|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325290|NCT00816829|O1|Outcome|Placebo|Placebo
325291|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325292|NCT00816829|O1|Outcome|Placebo|Placebo
325293|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325294|NCT00816829|O1|Outcome|Placebo|Placebo
325295|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325296|NCT00816829|O1|Outcome|Placebo|Placebo
325297|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325298|NCT00816829|O1|Outcome|Placebo|Placebo
325299|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325300|NCT00816829|O1|Outcome|Placebo|Placebo
325301|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325302|NCT00816829|O1|Outcome|Placebo|Placebo
325303|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325304|NCT00816829|O1|Outcome|Placebo|Placebo
325305|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
325310|NCT00816777|B2|Baseline|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325311|NCT00816777|B1|Baseline|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325312|NCT00816777|P2|Participant Flow|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325313|NCT00816777|P1|Participant Flow|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325314|NCT00816777|O2|Outcome|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325315|NCT00816777|O1|Outcome|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325316|NCT00816777|E2|Reported Event|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325317|NCT00816777|E1|Reported Event|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
325318|NCT00816595|B3|Baseline|Total|Total of all reporting groups
325319|NCT00816595|B2|Baseline|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325320|NCT00816595|B1|Baseline|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325321|NCT00816595|P2|Participant Flow|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325322|NCT00816595|P1|Participant Flow|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325323|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325324|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325325|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325374|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325375|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325326|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325327|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325328|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
325329|NCT00816595|E2|Reported Event|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325330|NCT00816595|E1|Reported Event|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
325331|NCT00816556|B4|Baseline|Total|Total of all reporting groups
325332|NCT00816556|B3|Baseline|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325333|NCT00816556|B2|Baseline|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325334|NCT00816556|B1|Baseline|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325335|NCT00816556|P3|Participant Flow|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325336|NCT00816556|P2|Participant Flow|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325337|NCT00816556|P1|Participant Flow|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325338|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325339|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325340|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325341|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325342|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325343|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325344|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325345|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325346|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325347|NCT00816556|E3|Reported Event|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325348|NCT00816556|E2|Reported Event|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325349|NCT00816556|E1|Reported Event|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
325350|NCT00816348|B1|Baseline|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
327786|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
325351|NCT00816348|P1|Participant Flow|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
325352|NCT00816348|O1|Outcome|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
325353|NCT00816348|E1|Reported Event|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
325354|NCT00816166|B3|Baseline|Total|Total of all reporting groups
325355|NCT00816166|B2|Baseline|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
325356|NCT00816166|B1|Baseline|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
325357|NCT00816166|P2|Participant Flow|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
325358|NCT00816166|P1|Participant Flow|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
325359|NCT00816166|O2|Outcome|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
325360|NCT00816166|O1|Outcome|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
325361|NCT00816166|E2|Reported Event|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
325362|NCT00816166|E1|Reported Event|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
325363|NCT00816101|B4|Baseline|Total|Total of all reporting groups
325364|NCT00816101|B3|Baseline|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325365|NCT00816101|B2|Baseline|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325366|NCT00816101|B1|Baseline|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325367|NCT00816101|P3|Participant Flow|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325368|NCT00816101|P2|Participant Flow|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325369|NCT00816101|P1|Participant Flow|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325370|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325371|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325372|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325373|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325459|NCT00815659|B1|Baseline|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325376|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325377|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325378|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325379|NCT00816101|E3|Reported Event|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
325380|NCT00816101|E2|Reported Event|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
325381|NCT00816101|E1|Reported Event|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
325382|NCT00816036|B3|Baseline|Total|Total of all reporting groups
325383|NCT00816036|B2|Baseline|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325384|NCT00816036|B1|Baseline|Arm 1|Pre-intervention Period
325385|NCT00816036|P2|Participant Flow|Intervention Period|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325386|NCT00816036|P1|Participant Flow|Pre-intervention Period|Pre-intervention Period
325387|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325388|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
325389|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325390|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
325391|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325392|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
325393|NCT00816036|E2|Reported Event|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
325394|NCT00816036|E1|Reported Event|Arm 1|Pre-intervention Period
325395|NCT00816023|B5|Baseline|Total|Total of all reporting groups
325396|NCT00816023|B4|Baseline|Placebo|
325397|NCT00816023|B3|Baseline|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
325398|NCT00816023|B2|Baseline|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
325399|NCT00816023|B1|Baseline|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
325400|NCT00816023|P4|Participant Flow|Placebo|
325401|NCT00816023|P3|Participant Flow|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
325402|NCT00816023|P2|Participant Flow|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
325403|NCT00816023|P1|Participant Flow|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
325404|NCT00816023|O4|Outcome|Placebo|
325405|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
325406|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
325407|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
325408|NCT00816023|O4|Outcome|Placebo|
325409|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
325410|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
325411|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
325412|NCT00816023|E4|Reported Event|PLACEBO|
325413|NCT00816023|E3|Reported Event|ECALLANTIDE LOW DOSE|Target steady state concentration of 0.15 mg/L
325414|NCT00816023|E2|Reported Event|ECALLANTIDE MEDIUM DOSE|Target steady state concentration of 0.75 mg/L
325415|NCT00816023|E1|Reported Event|ECALLANTIDE HIGH DOSE|Target steady state concentration of 2.25 mg/L
325416|NCT00815919|B1|Baseline|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325460|NCT00815659|P1|Participant Flow|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325417|NCT00815919|P1|Participant Flow|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325418|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325419|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325420|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325421|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325422|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325423|NCT00815919|E1|Reported Event|Velcade (Bortezomib)|"Prednisone : Taken orally once a day. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~bortezomib : Given intravenously once a week for the first four weeks of a five week cycle for a total of 3 cycles"
325424|NCT00815776|B4|Baseline|Total|Total of all reporting groups
325425|NCT00815776|B3|Baseline|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
325426|NCT00815776|B2|Baseline|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
325427|NCT00815776|B1|Baseline|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
325428|NCT00815776|P3|Participant Flow|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
325429|NCT00815776|P2|Participant Flow|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
325430|NCT00815776|P1|Participant Flow|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
325431|NCT00815776|O3|Outcome|Jaw Exercise Group|This subject group received no device but was assigned to complete a study-specified jaw exercise program
325432|NCT00815776|O2|Outcome|Mouth Splint Group|This group was not part of the analysis
325433|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|This group of subjects received the Clayton Intra-aural Device
325434|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
325435|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
325436|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
325437|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
325438|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
325439|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
325440|NCT00815776|E3|Reported Event|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
325441|NCT00815776|E2|Reported Event|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
325442|NCT00815776|E1|Reported Event|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
325443|NCT00815698|B3|Baseline|Total|Total of all reporting groups
325444|NCT00815698|B2|Baseline|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
325445|NCT00815698|B1|Baseline|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
325446|NCT00815698|P2|Participant Flow|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
325447|NCT00815698|P1|Participant Flow|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
325448|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
325449|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
325450|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
325451|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
325452|NCT00815698|E2|Reported Event|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
325453|NCT00815698|E1|Reported Event|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
325454|NCT00815685|B1|Baseline|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
325455|NCT00815685|P1|Participant Flow|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
325456|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
325457|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
325458|NCT00815685|E1|Reported Event|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
325754|NCT00815347|O1|Outcome|Placebo|
325461|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325462|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325463|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325464|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325465|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325466|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325467|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325468|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325469|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325470|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325471|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325472|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325473|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325474|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325475|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325476|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325477|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325478|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325479|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325480|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325481|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325482|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325483|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325484|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325485|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325486|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325487|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325488|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325489|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325490|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325491|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325492|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325493|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325494|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325495|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325496|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325497|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325498|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325499|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325500|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325501|NCT00815659|E1|Reported Event|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
325502|NCT00814892|B1|Baseline|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325503|NCT00814892|P1|Participant Flow|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325504|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325505|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325506|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325507|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325508|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325509|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325510|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325511|NCT00814892|E1|Reported Event|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
325512|NCT00814879|B3|Baseline|Total|Total of all reporting groups
325513|NCT00814879|B2|Baseline|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325514|NCT00814879|B1|Baseline|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325515|NCT00814879|P2|Participant Flow|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325516|NCT00814879|P1|Participant Flow|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325517|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325518|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325519|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325520|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325521|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325522|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325523|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325524|NCT00814879|O1|Outcome|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325525|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325526|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325527|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325528|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325529|NCT00814879|E2|Reported Event|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
325530|NCT00814879|E1|Reported Event|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
325531|NCT00814801|B4|Baseline|Total|Total of all reporting groups
325532|NCT00814801|B3|Baseline|Galantamine Group 2|Galantamine 24 mg/day
325533|NCT00814801|B2|Baseline|Galantamine Group 1|Galantamine 16 mg/day
325534|NCT00814801|B1|Baseline|Placebo Group|
325535|NCT00814801|P3|Participant Flow|Galantamine Group 2|Galantamine 24 mg/day
325536|NCT00814801|P2|Participant Flow|Galantamine Group 1|Galantamine 16 mg/day
325537|NCT00814801|P1|Participant Flow|Placebo Group|
325538|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
325539|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
325540|NCT00814801|O1|Outcome|Placebo Group|
325541|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
325542|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
325543|NCT00814801|O1|Outcome|Placebo Group|
325544|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
325545|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
325546|NCT00814801|O1|Outcome|Placebo Group|
325547|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
325548|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
325549|NCT00814801|O1|Outcome|Placebo Group|
325550|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
325551|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
325552|NCT00814801|O1|Outcome|Placebo Group|
325553|NCT00814801|E3|Reported Event|Galantamine Group 2|Galantamine 24 mg/day
325554|NCT00814801|E2|Reported Event|Galantamine Group 1|Galantamine 16 mg/day
325555|NCT00814801|E1|Reported Event|Placebo Group|
325556|NCT00814775|B3|Baseline|Total|Total of all reporting groups
325557|NCT00814775|B2|Baseline|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
325558|NCT00814775|B1|Baseline|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
325755|NCT00815347|O2|Outcome|Bosentan|
325756|NCT00815347|O1|Outcome|Placebo|
325559|NCT00814775|P2|Participant Flow|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
325560|NCT00814775|P1|Participant Flow|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
325561|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
325562|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
325563|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
325564|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
325565|NCT00814775|E2|Reported Event|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
325566|NCT00814775|E1|Reported Event|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
325567|NCT00814710|B3|Baseline|Total|Total of all reporting groups
325568|NCT00814710|B2|Baseline|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325569|NCT00814710|B1|Baseline|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325570|NCT00814710|P2|Participant Flow|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325571|NCT00814710|P1|Participant Flow|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325572|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325573|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325574|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325575|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325576|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325577|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325578|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325579|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325580|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325581|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325582|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325583|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325584|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325585|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325586|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325587|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325588|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325589|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325590|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325591|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325592|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325593|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325594|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325595|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325596|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325597|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325598|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325599|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325600|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325601|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325602|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325603|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325604|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325605|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325606|NCT00814710|E2|Reported Event|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325607|NCT00814710|E1|Reported Event|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
325608|NCT00814697|B1|Baseline|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
325609|NCT00814697|P1|Participant Flow|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
325610|NCT00814697|O1|Outcome|Cognitive Assessment|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
325611|NCT00814697|E1|Reported Event|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
325612|NCT00814671|B4|Baseline|Total|Total of all reporting groups
325613|NCT00814671|B3|Baseline|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325614|NCT00814671|B2|Baseline|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325615|NCT00814671|B1|Baseline|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325616|NCT00814671|P3|Participant Flow|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325617|NCT00814671|P2|Participant Flow|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325618|NCT00814671|P1|Participant Flow|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325757|NCT00815347|O2|Outcome|Bosentan|
325619|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325620|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325621|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325622|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325623|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325624|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325625|NCT00814671|E3|Reported Event|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325626|NCT00814671|E2|Reported Event|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325627|NCT00814671|E1|Reported Event|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
325628|NCT00814658|B3|Baseline|Total|Total of all reporting groups
325629|NCT00814658|B2|Baseline|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325630|NCT00814658|B1|Baseline|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325631|NCT00814658|P2|Participant Flow|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325632|NCT00814658|P1|Participant Flow|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325633|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325634|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325635|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325636|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325637|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325638|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325639|NCT00814658|O8|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325640|NCT00814658|O7|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325641|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 16)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325642|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 16)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325643|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325758|NCT00815347|O1|Outcome|Placebo|
325759|NCT00815347|O2|Outcome|Bosentan|
325760|NCT00815347|O1|Outcome|Placebo|
325761|NCT00815347|O2|Outcome|Bosentan|
325644|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325645|NCT00814658|O2|Outcome|Galantamine + Placebo (Week 4)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325646|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Week 4)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325647|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325648|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325649|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325650|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325651|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325652|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325653|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325654|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325655|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325656|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325657|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325658|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325659|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325660|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325661|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325662|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325663|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325664|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325665|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325666|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325762|NCT00815347|O1|Outcome|Placebo|
325667|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325668|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325669|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325670|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325671|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325672|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325673|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325674|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325675|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325676|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325677|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325678|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325679|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325680|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325681|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325682|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325683|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325684|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325685|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325686|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325687|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325688|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325689|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325763|NCT00815347|E2|Reported Event|Placebo|Placebo orally, twice a day for four weeks.
325690|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325691|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325692|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325693|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325694|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325695|NCT00814658|E2|Reported Event|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
325696|NCT00814658|E1|Reported Event|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
325697|NCT00815516|B3|Baseline|Total|Total of all reporting groups
325698|NCT00815516|B2|Baseline|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325699|NCT00815516|B1|Baseline|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325700|NCT00815516|P2|Participant Flow|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325701|NCT00815516|P1|Participant Flow|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325702|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325703|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325704|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325705|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325706|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325707|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325708|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325709|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325710|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325711|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325712|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325713|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325714|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325715|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325716|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325717|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325718|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325719|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325720|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325721|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325722|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325723|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325724|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325725|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325726|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325727|NCT00815516|E2|Reported Event|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325728|NCT00815516|E1|Reported Event|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
325729|NCT00815490|B3|Baseline|Total|Total of all reporting groups
325730|NCT00815490|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
325731|NCT00815490|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
325732|NCT00815490|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
325733|NCT00815490|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
325734|NCT00815490|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
325735|NCT00815490|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
325736|NCT00815490|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
325737|NCT00815490|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
325738|NCT00815360|B3|Baseline|Total|Total of all reporting groups
325739|NCT00815360|B2|Baseline|Comparative Group 1|Intravitreal triamcinolone with macular laser
325740|NCT00815360|B1|Baseline|Treatment Group 1|ranibizumab and scatter laser
325741|NCT00815360|P2|Participant Flow|Comparative Group 1|Intravitreal triamcinolone with macular laser
325742|NCT00815360|P1|Participant Flow|Treatment Group 1|ranibizumab and scatter laser
325743|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
325744|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
325745|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
325746|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
325747|NCT00815360|E2|Reported Event|Comparative Group 1|Intravitreal triamcinolone acetonide and macular laser
325748|NCT00815360|E1|Reported Event|Treatment Group 1|Intravitreal ranibizumab and peripheral laser
325749|NCT00815347|B1|Baseline|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
325750|NCT00815347|P1|Participant Flow|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
325751|NCT00815347|O2|Outcome|Bosentan|
325752|NCT00815347|O1|Outcome|Placebo|
325753|NCT00815347|O2|Outcome|Bosentan|
325764|NCT00815347|E1|Reported Event|Bosentan|Bosentan 62.5mg orally, twice a day for four weeks.
325765|NCT00815308|B1|Baseline|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325766|NCT00815308|P1|Participant Flow|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325767|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325768|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325769|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325770|NCT00815308|E1|Reported Event|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
325771|NCT00815295|B4|Baseline|Total|Total of all reporting groups
325772|NCT00815295|B3|Baseline|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
325773|NCT00815295|B2|Baseline|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
325774|NCT00815295|B1|Baseline|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
325775|NCT00815295|P3|Participant Flow|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
325776|NCT00815295|P2|Participant Flow|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
325777|NCT00815295|P1|Participant Flow|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
325778|NCT00815295|O1|Outcome|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
325779|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
325780|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
325781|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
325782|NCT00815295|O1|Outcome|Phase 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg or 400 mg was administered orally twice daily. The dose of sorafenib was escalated from 200 mg to 400 mg in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT).
325783|NCT00815295|E3|Reported Event|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
325784|NCT00815295|E2|Reported Event|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily.
325785|NCT00815295|E1|Reported Event|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily.
325786|NCT00815191|B3|Baseline|Total|Total of all reporting groups
325787|NCT00815191|B2|Baseline|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
325788|NCT00815191|B1|Baseline|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
325789|NCT00815191|P2|Participant Flow|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
325790|NCT00815191|P1|Participant Flow|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
325791|NCT00815191|O2|Outcome|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
325792|NCT00815191|O1|Outcome|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
325793|NCT00815191|E2|Reported Event|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
325794|NCT00815191|E1|Reported Event|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
325795|NCT00815087|B3|Baseline|Total|Total of all reporting groups
325796|NCT00815087|B2|Baseline|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
325797|NCT00815087|B1|Baseline|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
325798|NCT00815087|P2|Participant Flow|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
325799|NCT00815087|P1|Participant Flow|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
325800|NCT00815087|O2|Outcome|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
325801|NCT00815087|O1|Outcome|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
325802|NCT00815087|E2|Reported Event|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
325803|NCT00815087|E1|Reported Event|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
325804|NCT00814983|B3|Baseline|Total|Total of all reporting groups
325805|NCT00814983|B2|Baseline|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325806|NCT00814983|B1|Baseline|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325807|NCT00814983|P2|Participant Flow|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325808|NCT00814983|P1|Participant Flow|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325809|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325810|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325811|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325812|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325813|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325814|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325815|NCT00814983|E2|Reported Event|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
325816|NCT00814983|E1|Reported Event|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
325840|NCT00814632|O1|Outcome|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
325817|NCT00814970|B1|Baseline|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325818|NCT00814970|P1|Participant Flow|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325819|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
325820|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
325821|NCT00814970|O1|Outcome|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325822|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
325823|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325824|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325825|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325826|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325827|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325828|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325829|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325830|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325831|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325832|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325833|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325834|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325835|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325836|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
325837|NCT00814970|E1|Reported Event|1. Complete SE Vascular Stent System|Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
325838|NCT00814632|B1|Baseline|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
325839|NCT00814632|P1|Participant Flow|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
325841|NCT00814632|E1|Reported Event|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
325842|NCT00814580|B3|Baseline|Total|Total of all reporting groups
325843|NCT00814580|B2|Baseline|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325844|NCT00814580|B1|Baseline|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325845|NCT00814580|P2|Participant Flow|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325846|NCT00814580|P1|Participant Flow|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325847|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325848|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325849|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325850|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325851|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325852|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325853|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325854|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325855|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325856|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325857|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325858|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325859|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325860|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325861|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325862|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325863|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325864|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325865|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325866|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325867|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325868|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325869|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325870|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325871|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325872|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325873|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325874|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325875|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325876|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325877|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325878|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325879|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325880|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325881|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325882|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325883|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325884|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325885|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325886|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325887|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325888|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325889|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325890|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325891|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325892|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325893|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325894|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325895|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325896|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325897|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325898|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325899|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325900|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325901|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325902|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325903|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325904|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325905|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325906|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325907|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325908|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325909|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325910|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325911|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325912|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325913|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325914|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325915|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325916|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325917|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325918|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325919|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
325920|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
325921|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325922|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325923|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325924|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
325925|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
325926|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
325927|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
325928|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
325929|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
325930|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
325931|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325932|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325933|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325934|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325935|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
326135|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
325936|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325937|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325938|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325939|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325940|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325941|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325942|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325943|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325944|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325945|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325946|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325947|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325948|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325949|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325950|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325951|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325952|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325953|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325954|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325955|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325956|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325957|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325958|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325959|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325960|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325961|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325962|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325963|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325964|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325965|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325966|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325967|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325968|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325969|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325970|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325971|NCT00814580|E2|Reported Event|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
325972|NCT00814580|E1|Reported Event|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
325973|NCT00814489|B4|Baseline|Total|Total of all reporting groups
325974|NCT00814489|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325975|NCT00814489|B2|Baseline|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325976|NCT00814489|B1|Baseline|GSK2254233A Group|Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325977|NCT00814489|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325978|NCT00814489|P2|Participant Flow|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326007|NCT00814489|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325979|NCT00814489|P1|Participant Flow|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325980|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325981|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325982|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325983|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325984|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325985|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325986|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325987|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325988|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325989|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325990|NCT00814489|O2|Outcome|GSK2254232A Non-adjuvanted Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325991|NCT00814489|O1|Outcome|GSK2254232A Adjuvanted Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325992|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325993|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325994|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325995|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325996|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325997|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325998|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
325999|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326000|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326001|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326002|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326003|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326004|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326005|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326006|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326132|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326008|NCT00814489|E2|Reported Event|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326009|NCT00814489|E1|Reported Event|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
326010|NCT00814463|B1|Baseline|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
326011|NCT00814463|P1|Participant Flow|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
326012|NCT00814463|O1|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
326013|NCT00814463|E1|Reported Event|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
326014|NCT00814346|B3|Baseline|Total|Total of all reporting groups
326015|NCT00814346|B2|Baseline|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
326016|NCT00814346|B1|Baseline|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
326017|NCT00814346|P2|Participant Flow|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
326018|NCT00814346|P1|Participant Flow|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
326019|NCT00814346|O2|Outcome|EGb761 120 mg (MC)|EGb761 120 mg 17 months (open phase) for MC patients
326020|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326021|NCT00814346|O3|Outcome|EGb761 120 mg (Open Phase)|EGb761 120 mg twice a day for 17 months (open phase) for MC and CNE patients
326022|NCT00814346|O2|Outcome|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
326023|NCT00814346|O1|Outcome|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
326024|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326025|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326026|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326027|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326028|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326029|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326030|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326031|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326032|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326033|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326034|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326035|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326133|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326036|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326037|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326038|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326039|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326040|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326041|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326042|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (Open phase) for MC patients
326043|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326044|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326045|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326046|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326047|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326048|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326049|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326050|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326051|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326052|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326053|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326054|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326055|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326056|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326057|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326058|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326059|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326060|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326061|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326062|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326063|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326064|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326065|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326066|NCT00814346|O4|Outcome|Placebo (MC)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
326067|NCT00814346|O3|Outcome|EGb761 120 mg (MC)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
326068|NCT00814346|O2|Outcome|Placebo (CNE)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
326069|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
326070|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326071|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326072|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
326073|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326074|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patient
326075|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326076|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg 17 months (open phase) for MC patients
326077|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
326078|NCT00814346|E3|Reported Event|EGb761 120 mg (Open Phase)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC and CNE patients
326079|NCT00814346|E2|Reported Event|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
326080|NCT00814346|E1|Reported Event|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
326081|NCT00814333|B3|Baseline|Total|Total of all reporting groups
326082|NCT00814333|B2|Baseline|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
326083|NCT00814333|B1|Baseline|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
326084|NCT00814333|P2|Participant Flow|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
326134|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326085|NCT00814333|P1|Participant Flow|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
326086|NCT00814333|O2|Outcome|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
326087|NCT00814333|O1|Outcome|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
326088|NCT00814333|E2|Reported Event|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
326089|NCT00814333|E1|Reported Event|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
326090|NCT00814320|B3|Baseline|Total|Total of all reporting groups
326091|NCT00814320|B2|Baseline|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV).~Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603).~EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
326092|NCT00814320|B1|Baseline|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
326093|NCT00814320|P2|Participant Flow|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%.~Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study.~EPOCH 2 RAMP-UP (ramp-up):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG.~EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
326094|NCT00814320|P1|Participant Flow|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
326095|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
326096|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
326097|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326098|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326099|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326100|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326101|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326102|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326103|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 With Ramp-up|
326104|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326105|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326106|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326107|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326108|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326109|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326110|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326111|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326112|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326113|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326114|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326115|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326116|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326117|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326118|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326119|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326120|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326121|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326122|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326123|NCT00814320|O2|Outcome|Study Epoch 2|Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
326124|NCT00814320|O1|Outcome|Study Epoch 1|Epoch 1 - IV administration of IGIV, 10%
326125|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326126|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326127|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|
326128|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326129|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326130|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326131|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326137|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326138|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326139|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326140|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326141|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326142|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20 at Ramp-up|At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)
326143|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326144|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326145|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
326146|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326147|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326148|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326149|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326150|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326151|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326152|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326153|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326154|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326155|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326156|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326157|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326158|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326159|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326160|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326161|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326162|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326163|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
326164|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326165|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326166|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326167|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326168|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326169|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326170|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326171|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326172|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326173|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326174|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326175|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326176|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326177|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326178|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326179|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326180|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326181|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326182|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326183|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326184|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326185|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326186|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326187|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326188|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326189|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326190|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326191|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326192|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326193|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326194|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326195|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326196|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326197|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326198|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326199|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
326200|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326201|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
326202|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326203|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
326204|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326205|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
326206|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326207|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
326208|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326209|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
326210|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326211|NCT00814320|O2|Outcome|Participants ≥12 Years|
326212|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
326213|NCT00814320|O2|Outcome|SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up|
326214|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
326215|NCT00814320|O1|Outcome|Ratio IgG AUC of SC With and Without rHuPH20|Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
326216|NCT00814320|O1|Outcome|%Ratio IgG Trough Level of SC/IV|Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
326217|NCT00814320|O1|Outcome|% Ratio IgG AUC/Week of SC/ IV|Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
326218|NCT00814320|O1|Outcome|Full Analysis Data Set (FADS)|All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
326219|NCT00814320|E2|Reported Event|SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)|"Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up.~Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC.~During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
326220|NCT00814320|E1|Reported Event|IV Administration of IGIV, 10%|Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
326221|NCT00814307|B5|Baseline|Total|Total of all reporting groups
326222|NCT00814307|B4|Baseline|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326223|NCT00814307|B3|Baseline|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326224|NCT00814307|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326225|NCT00814307|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326226|NCT00814307|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326227|NCT00814307|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326228|NCT00814307|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326229|NCT00814307|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326230|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326231|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326232|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326233|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326234|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326235|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326236|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326237|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326238|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326239|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326240|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326241|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326242|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326243|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326244|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326245|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326246|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326247|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326248|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326249|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326250|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326251|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326252|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326253|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326254|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326255|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326256|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326257|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326258|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326259|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326260|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326261|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326262|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326263|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326264|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326265|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326266|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326267|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326268|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326269|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326270|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326271|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326272|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326273|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326274|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326275|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326276|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326277|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326278|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326279|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326280|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326281|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326282|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326283|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326284|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326285|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326286|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326287|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326288|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326289|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326290|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326291|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326292|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326293|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326294|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326295|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326296|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326297|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326298|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326299|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326300|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326301|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326302|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326303|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326304|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326305|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326306|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326307|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326308|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326309|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326310|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326311|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326312|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326313|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326314|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326315|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326316|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326317|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326318|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326319|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326320|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326321|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326322|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326323|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326324|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326325|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326326|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326327|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326328|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326329|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326330|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326331|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326332|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326333|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326334|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326335|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326336|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326337|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326338|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326339|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326340|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326341|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326342|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326343|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326344|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326345|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326346|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326347|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326348|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326349|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326350|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326351|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326352|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326353|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326354|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326355|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326356|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326357|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326358|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326359|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326360|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326361|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326362|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326363|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326364|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326365|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326366|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326367|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326368|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326369|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326370|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
326371|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326372|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326373|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326374|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326375|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326376|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326377|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326378|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326379|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326380|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326381|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326382|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
326383|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
326384|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
326385|NCT00814307|E5|Reported Event|CP-690550 10 mg (Post Month 3)|CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
326386|NCT00814307|E4|Reported Event|CP-690550 5 mg (Post Month 3)|CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
326387|NCT00814307|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo tablet orally twice daily up to Month 3.
326388|NCT00814307|E2|Reported Event|CP-690550 10 mg (Up To Month 3)|CP-690550 10 mg tablet orally twice daily up to Month 3.
326389|NCT00814307|E1|Reported Event|CP-690550 5 mg (Up To Month 3)|CP-690550 5 mg tablet orally twice daily up to Month 3.
326390|NCT00814255|B4|Baseline|Total|Total of all reporting groups
326391|NCT00814255|B3|Baseline|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
326392|NCT00814255|B2|Baseline|Conservative Medical Therapy|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326393|NCT00814255|B1|Baseline|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326394|NCT00814255|P3|Participant Flow|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
326395|NCT00814255|P2|Participant Flow|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326396|NCT00814255|P1|Participant Flow|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326397|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
326398|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326399|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326466|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
326400|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
326401|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326402|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326403|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
326404|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326405|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326406|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
326407|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326408|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326409|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID 2 out of 7"
326410|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day 2 out of 7"
326411|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7"
326412|NCT00814255|E3|Reported Event|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
326413|NCT00814255|E2|Reported Event|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
326414|NCT00814255|E1|Reported Event|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
326415|NCT00814177|B3|Baseline|Total|Total of all reporting groups
326416|NCT00814177|B2|Baseline|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
326417|NCT00814177|B1|Baseline|No Change|Intervention Drug warfarin no change in the dose is performed
326418|NCT00814177|P2|Participant Flow|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
326419|NCT00814177|P1|Participant Flow|No Change|Intervention Drug warfarin no change in the dose is performed
326420|NCT00814177|O2|Outcome|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
326421|NCT00814177|O1|Outcome|No Change|Intervention Drug warfarin no change in the dose is performed
326422|NCT00814177|E2|Reported Event|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
326423|NCT00814177|E1|Reported Event|No Change|Intervention Drug warfarin no change in the dose is performed
326424|NCT00814164|B1|Baseline|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326425|NCT00814164|P1|Participant Flow|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326426|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326427|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326428|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326467|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
326429|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326430|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326431|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326432|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326433|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326434|NCT00814164|E1|Reported Event|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
326435|NCT00814138|B3|Baseline|Total|Total of all reporting groups
326436|NCT00814138|B2|Baseline|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326437|NCT00814138|B1|Baseline|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326438|NCT00814138|P2|Participant Flow|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326439|NCT00814138|P1|Participant Flow|1 - Methotrexate (2.5 mg)|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326440|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326441|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326442|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326443|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326444|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326445|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326446|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326447|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326448|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326449|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326450|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
326451|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
326452|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326453|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
326454|NCT00814138|E2|Reported Event|Placebo Group - Adverse Events|Reported the number of adverse events in the group randomized to placebo
326455|NCT00814138|E1|Reported Event|Methotrexate Group - Adverse Events|Reported the number of adverse events in the group randomized to methotrexate.
326456|NCT00813995|B3|Baseline|Total|Total of all reporting groups
326457|NCT00813995|B2|Baseline|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
326458|NCT00813995|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
326459|NCT00813995|P2|Participant Flow|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
326460|NCT00813995|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
326461|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
326462|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
326463|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
326464|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
326465|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
326468|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
326469|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
326470|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
326471|NCT00813995|E2|Reported Event|Placebo|
326472|NCT00813995|E1|Reported Event|Sitagliptin|
326473|NCT00813982|B1|Baseline|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
326474|NCT00813982|P1|Participant Flow|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
326475|NCT00813982|O2|Outcome|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
326476|NCT00813982|O1|Outcome|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
326477|NCT00813982|E2|Reported Event|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens
326478|NCT00813982|E1|Reported Event|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens
326479|NCT00813943|B4|Baseline|Total|Total of all reporting groups
326480|NCT00813943|B3|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326481|NCT00813943|B2|Baseline|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326482|NCT00813943|B1|Baseline|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326483|NCT00813943|P3|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326484|NCT00813943|P2|Participant Flow|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326485|NCT00813943|P1|Participant Flow|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326486|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326487|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326538|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326488|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326489|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326490|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326491|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326492|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326493|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326494|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326495|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326496|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326497|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326498|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326499|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326500|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326501|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326502|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326503|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326504|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326505|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326506|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326507|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326508|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326509|NCT00813943|E3|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
326564|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
329143|NCT00808249|P4|Participant Flow|D-Placebo|Placebo
326510|NCT00813943|E2|Reported Event|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326511|NCT00813943|E1|Reported Event|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
326512|NCT00813917|B3|Baseline|Total|Total of all reporting groups
326513|NCT00813917|B2|Baseline|Placebo|nonactive lookalike pill per day for 12 weeks
326514|NCT00813917|B1|Baseline|Varenicline|varenicline-1mg/day for 12 weeks
326515|NCT00813917|P2|Participant Flow|Placebo|nonactive lookalike pill per day for 12 weeks
326516|NCT00813917|P1|Participant Flow|Varenicline|varenicline-1mg/day for 12 weeks
326517|NCT00813917|O2|Outcome|Placebo|nonactive lookalike pill per day for 12 weeks
326518|NCT00813917|O1|Outcome|Varenicline|varenicline-1mg/day for 12 weeks
326519|NCT00813917|E2|Reported Event|Placebo|nonactive lookalike pill per day for 12 weeks
326520|NCT00813917|E1|Reported Event|Varenicline|varenicline-1mg/day for 12 weeks
326521|NCT00813904|B1|Baseline|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
326522|NCT00813904|P1|Participant Flow|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
326523|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
326524|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
326525|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
326526|NCT00813904|E1|Reported Event|TOTAL|
326527|NCT00813813|B3|Baseline|Total|Total of all reporting groups
326528|NCT00813813|B2|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326529|NCT00813813|B1|Baseline|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326530|NCT00813813|P2|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326531|NCT00813813|P1|Participant Flow|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326532|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326533|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326534|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326535|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326536|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326537|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326539|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326540|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326541|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326542|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326543|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326544|NCT00813813|E2|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326545|NCT00813813|E1|Reported Event|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
326546|NCT00813800|B1|Baseline|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326547|NCT00813800|P1|Participant Flow|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326548|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326549|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326550|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326551|NCT00813800|E1|Reported Event|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
326552|NCT00813761|B3|Baseline|Total|Total of all reporting groups
326553|NCT00813761|B2|Baseline|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326554|NCT00813761|B1|Baseline|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326555|NCT00813761|P4|Participant Flow|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
326556|NCT00813761|P3|Participant Flow|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
326557|NCT00813761|P2|Participant Flow|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
326558|NCT00813761|P1|Participant Flow|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
326559|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326560|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326561|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326562|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326563|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
329144|NCT00808249|P3|Participant Flow|C-AZD7325 10 mg|AZD7325 10 mg QD
326565|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326566|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326567|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326568|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326569|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326570|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
326571|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326572|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326573|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326574|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326575|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326576|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326577|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326578|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326579|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326580|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326581|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326582|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326583|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326584|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326585|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326586|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326587|NCT00813761|O2|Outcome|ReNU MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
326588|NCT00813761|O1|Outcome|Clear Care LCS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
326589|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326590|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326591|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326592|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326593|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326594|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326595|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326596|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326597|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
326598|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
326599|NCT00813761|O2|Outcome|ReNU Multi Purpose Solution (MPS)|All subjects assigned to ReNU MPS
326600|NCT00813761|O1|Outcome|Clear Care Lens Cleaning Solution (LCS)|All subjects assigned to Clear Care LCS
326601|NCT00813761|E4|Reported Event|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
326602|NCT00813761|E3|Reported Event|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
326603|NCT00813761|E2|Reported Event|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose
326604|NCT00813761|E1|Reported Event|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
326605|NCT00813748|B3|Baseline|Total|Total of all reporting groups
326606|NCT00813748|B2|Baseline|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326607|NCT00813748|B1|Baseline|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326608|NCT00813748|P2|Participant Flow|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326609|NCT00813748|P1|Participant Flow|Omalizumab Cases|Participants who received omalizumab (Xolair) and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326881|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326882|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326610|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326611|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326612|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326613|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326614|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326615|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326616|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
326617|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326618|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326619|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326620|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326621|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326622|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326623|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326624|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326625|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326626|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326627|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326628|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326629|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326630|NCT00813748|E4|Reported Event|Skin Test Substudy: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
326631|NCT00813748|E3|Reported Event|Skin Test Substudy: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326632|NCT00813748|E2|Reported Event|Observational Study: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
326633|NCT00813748|E1|Reported Event|Observational Study: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
326634|NCT00813709|B4|Baseline|Total|Total of all reporting groups
326635|NCT00813709|B3|Baseline|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (18 participants from DB converted to CDMS and switched to OL period over course of this study)
326636|NCT00813709|B2|Baseline|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (26 participants from DB converted to CDMS and switched to OL period over course of this study)
326637|NCT00813709|B1|Baseline|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (9 participants from DB converted to CDMS and switched to OL period over course of this study)
326638|NCT00813709|P6|Participant Flow|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326639|NCT00813709|P5|Participant Flow|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326640|NCT00813709|P4|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326641|NCT00813709|P3|Participant Flow|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326642|NCT00813709|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326643|NCT00813709|P1|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326644|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326645|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326883|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326646|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326647|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326648|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326649|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326650|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326651|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326652|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326653|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326654|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326655|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326656|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326743|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326657|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326658|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326659|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326660|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326661|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326662|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326663|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326664|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326665|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326666|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326744|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326667|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326668|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
326669|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
326670|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
326671|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
326672|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
326673|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
326674|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326745|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326884|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326675|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326676|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326677|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326678|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326679|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
326680|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
326681|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
326682|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326683|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
326684|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
326685|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326686|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326746|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326885|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326886|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326687|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326688|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326689|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326690|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326691|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326692|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326693|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326694|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326695|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326696|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326887|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326888|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326697|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326698|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326699|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326700|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326701|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326702|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326703|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326704|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326705|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326726|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326706|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326707|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326708|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326709|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326710|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326711|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326712|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326713|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326714|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326727|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326715|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
326716|NCT00813709|E6|Reported Event|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326717|NCT00813709|E5|Reported Event|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326718|NCT00813709|E4|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
326719|NCT00813709|E3|Reported Event|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326720|NCT00813709|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
326721|NCT00813709|E1|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
326722|NCT00813592|B1|Baseline|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326723|NCT00813592|P1|Participant Flow|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326724|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326725|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326889|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326890|NCT00813098|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake
326728|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326729|NCT00813592|O1|Outcome|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326730|NCT00813592|E1|Reported Event|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
326731|NCT00813488|B1|Baseline|Total Number of Patients|
326732|NCT00813488|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
326733|NCT00813488|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
326734|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326735|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326736|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326737|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326738|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326739|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326740|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326741|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326742|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326891|NCT00813098|E2|Reported Event|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326892|NCT00813098|E1|Reported Event|High Dose|A high dose of LX1031; daily oral intake for 28 days
326893|NCT00812968|B1|Baseline|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326747|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326748|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
326749|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326750|NCT00813488|O1|Outcome|Total|"Includes all patients who participated in the double-blind treatment period and completed treatment.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326751|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326752|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326753|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326754|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326755|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326756|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326757|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326758|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326759|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326897|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326760|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326761|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326762|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326763|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326764|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326765|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326766|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326767|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326768|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326769|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326770|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326782|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326771|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326772|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326773|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326774|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326775|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326776|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326777|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326778|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326779|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326780|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326781|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326894|NCT00812968|P1|Participant Flow|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
326783|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326784|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326785|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326786|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326787|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326788|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326789|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326790|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326791|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326792|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326793|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326895|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326896|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326947|NCT00812955|E4|Reported Event|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
326794|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326795|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326796|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326797|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326798|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326799|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326800|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326801|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326802|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326803|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326804|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326816|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326805|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326806|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326807|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326808|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326809|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326810|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326811|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326812|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326813|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326814|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326815|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326873|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326874|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326875|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326876|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326817|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326818|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326819|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326820|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326821|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326822|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326823|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
326824|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
326825|NCT00813488|E3|Reported Event|Standard of Care|21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
326826|NCT00813488|E2|Reported Event|Oxycodone|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone
326827|NCT00813488|E1|Reported Event|Fentanyl Buccal Tablet|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT
326828|NCT00813319|B3|Baseline|Total|Total of all reporting groups
326829|NCT00813319|B2|Baseline|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326877|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326878|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326879|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
329145|NCT00808249|P2|Participant Flow|B-AZD7325 5 mg|AZD7325 5 mg BID
326830|NCT00813319|B1|Baseline|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326831|NCT00813319|P2|Participant Flow|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326832|NCT00813319|P1|Participant Flow|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326833|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326834|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326835|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326836|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326837|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326838|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326839|NCT00813319|E2|Reported Event|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
326840|NCT00813319|E1|Reported Event|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
326841|NCT00813150|B3|Baseline|Total|Total of all reporting groups
326842|NCT00813150|B2|Baseline|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326843|NCT00813150|B1|Baseline|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326844|NCT00813150|P2|Participant Flow|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326845|NCT00813150|P1|Participant Flow|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326880|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
326846|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326847|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326848|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326849|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326850|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326851|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326852|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326853|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326854|NCT00813150|E2|Reported Event|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
326855|NCT00813150|E1|Reported Event|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
326856|NCT00813111|B3|Baseline|Total|Total of all reporting groups
326857|NCT00813111|B2|Baseline|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
326858|NCT00813111|B1|Baseline|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
326859|NCT00813111|P2|Participant Flow|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
326860|NCT00813111|P1|Participant Flow|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
326861|NCT00813111|O2|Outcome|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
326862|NCT00813111|O1|Outcome|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
326863|NCT00813111|E2|Reported Event|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
326864|NCT00813111|E1|Reported Event|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
326865|NCT00813098|B4|Baseline|Total|Total of all reporting groups
326866|NCT00813098|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake
326867|NCT00813098|B2|Baseline|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326868|NCT00813098|B1|Baseline|High Dose|A high dose of LX1031; daily oral intake for 28 days
326869|NCT00813098|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake
326870|NCT00813098|P2|Participant Flow|Low Dose|A low dose of LX1031; daily oral intake for 28 days
326871|NCT00813098|P1|Participant Flow|High Dose|A high dose of LX1031; daily oral intake for 28 days
326872|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
326898|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326899|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326900|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326901|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326902|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326903|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326904|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326905|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326906|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326907|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326908|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326909|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326910|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326911|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326912|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326913|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326914|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326915|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326916|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326917|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326918|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326919|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326920|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
326921|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
326922|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326923|NCT00812968|E1|Reported Event|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
326924|NCT00812955|B5|Baseline|Total|Total of all reporting groups
326925|NCT00812955|B4|Baseline|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
326926|NCT00812955|B3|Baseline|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
326927|NCT00812955|B2|Baseline|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
326928|NCT00812955|B1|Baseline|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
326929|NCT00812955|P4|Participant Flow|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
326930|NCT00812955|P3|Participant Flow|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
326931|NCT00812955|P2|Participant Flow|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
326932|NCT00812955|P1|Participant Flow|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
326933|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
326934|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
326935|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
326936|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
326937|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
326938|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
326939|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
326940|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
326941|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg
326942|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
326943|NCT00812955|O2|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg
326944|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
326945|NCT00812955|O2|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg
326946|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
326948|NCT00812955|E3|Reported Event|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
326949|NCT00812955|E2|Reported Event|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
326950|NCT00812955|E1|Reported Event|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
326951|NCT00812916|B1|Baseline|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326952|NCT00812916|P1|Participant Flow|Number of Patients|Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326953|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
326954|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326955|NCT00812916|O1|Outcome|RF Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326956|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
326957|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326958|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326959|NCT00812916|E1|Reported Event|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
326960|NCT00812877|B3|Baseline|Total|Total of all reporting groups
326961|NCT00812877|B2|Baseline|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
326962|NCT00812877|B1|Baseline|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
326963|NCT00812877|P2|Participant Flow|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
326964|NCT00812877|P1|Participant Flow|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
326965|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
326966|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
326967|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
326968|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
326969|NCT00812877|E2|Reported Event|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
326970|NCT00812877|E1|Reported Event|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
326971|NCT00812812|B3|Baseline|Total|Total of all reporting groups
326972|NCT00812812|B2|Baseline|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326973|NCT00812812|B1|Baseline|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326974|NCT00812812|P2|Participant Flow|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326975|NCT00812812|P1|Participant Flow|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326976|NCT00812812|O1|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326977|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326978|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326979|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326980|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
327021|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327022|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327550|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
326981|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326982|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326983|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326984|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326985|NCT00812812|E2|Reported Event|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
326986|NCT00812812|E1|Reported Event|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
326987|NCT00812604|B3|Baseline|Total|Total of all reporting groups
326988|NCT00812604|B2|Baseline|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
326989|NCT00812604|B1|Baseline|Ping On Ointment Group|Ping On Ointment was used
326990|NCT00812604|P2|Participant Flow|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
326991|NCT00812604|P1|Participant Flow|Ping On Ointment Group|Ping On Ointment was used
326992|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
326993|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
326994|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
326995|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
326996|NCT00812604|E2|Reported Event|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
326997|NCT00812604|E1|Reported Event|Ping On Ointment Group|Ping On Ointment was used
326998|NCT00812565|B9|Baseline|Total|Total of all reporting groups
326999|NCT00812565|B8|Baseline|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327000|NCT00812565|B7|Baseline|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327001|NCT00812565|B6|Baseline|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327002|NCT00812565|B5|Baseline|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327003|NCT00812565|B4|Baseline|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327004|NCT00812565|B3|Baseline|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327005|NCT00812565|B2|Baseline|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327006|NCT00812565|B1|Baseline|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327007|NCT00812565|P8|Participant Flow|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327008|NCT00812565|P7|Participant Flow|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327009|NCT00812565|P6|Participant Flow|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327010|NCT00812565|P5|Participant Flow|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327011|NCT00812565|P4|Participant Flow|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327012|NCT00812565|P3|Participant Flow|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327013|NCT00812565|P2|Participant Flow|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327014|NCT00812565|P1|Participant Flow|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327015|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327016|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327017|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327018|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327019|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327020|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327023|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327024|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327025|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327026|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327027|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327028|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327029|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327030|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327031|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327032|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327033|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327034|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327035|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327036|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327037|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327038|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327039|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327040|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327041|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327042|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327043|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327044|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327045|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327046|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327047|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327048|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327049|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327050|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327051|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327052|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327053|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327054|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327055|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327056|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327057|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327058|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327059|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327060|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327061|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327062|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327063|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327064|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327065|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327066|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327067|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327068|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327069|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327070|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327071|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327072|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327073|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327074|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327075|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327076|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327077|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327078|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327079|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327080|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327081|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327082|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327083|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327084|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327085|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327086|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327087|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327088|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327089|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327090|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327091|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327092|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327093|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327094|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327095|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327096|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327097|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327098|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327099|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327100|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327101|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327102|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327103|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327104|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327105|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327106|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327107|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327108|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327109|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327110|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327111|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327112|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327113|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327114|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327115|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327116|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327117|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327118|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327119|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327120|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327121|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327122|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327123|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327124|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327125|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327126|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327127|NCT00812565|E8|Reported Event|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327128|NCT00812565|E7|Reported Event|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
327129|NCT00812565|E6|Reported Event|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327130|NCT00812565|E5|Reported Event|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
327131|NCT00812565|E4|Reported Event|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327132|NCT00812565|E3|Reported Event|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
327133|NCT00812565|E2|Reported Event|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327134|NCT00812565|E1|Reported Event|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
327135|NCT00812487|B3|Baseline|Total|Total of all reporting groups
327136|NCT00812487|B2|Baseline|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327137|NCT00812487|B1|Baseline|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327138|NCT00812487|P2|Participant Flow|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327139|NCT00812487|P1|Participant Flow|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327140|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327141|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327142|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327143|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327144|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327145|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327146|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327147|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327148|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327149|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327150|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327151|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327551|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327152|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327153|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327154|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327155|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327156|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327157|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327158|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327159|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327160|NCT00812487|E2|Reported Event|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
327161|NCT00812487|E1|Reported Event|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
327162|NCT00812461|B3|Baseline|Total|Total of all reporting groups
327163|NCT00812461|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327164|NCT00812461|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
327165|NCT00812461|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327166|NCT00812461|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
327167|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327168|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327169|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327170|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327171|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327172|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327173|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327174|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327175|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327176|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327177|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327178|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327179|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327180|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327181|NCT00812461|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327182|NCT00812461|E1|Reported Event|Placebo|as-needed use, tablets, orally, 6 months
327183|NCT00812331|B6|Baseline|Total|Total of all reporting groups
327184|NCT00812331|B5|Baseline|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327185|NCT00812331|B4|Baseline|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327186|NCT00812331|B3|Baseline|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327187|NCT00812331|B2|Baseline|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327188|NCT00812331|B1|Baseline|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327189|NCT00812331|P5|Participant Flow|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327190|NCT00812331|P4|Participant Flow|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327191|NCT00812331|P3|Participant Flow|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327192|NCT00812331|P2|Participant Flow|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327193|NCT00812331|P1|Participant Flow|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327194|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327195|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327196|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327197|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327198|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327199|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327200|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327201|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327202|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327203|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327204|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327205|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327206|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327207|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327208|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327209|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327210|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327211|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327212|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327213|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327214|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327215|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327216|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327217|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327218|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327219|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327220|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327221|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327222|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327223|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327224|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327225|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327226|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327227|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327228|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327229|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327230|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327231|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327232|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327233|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327234|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327235|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327236|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327237|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327238|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327239|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
329146|NCT00808249|P1|Participant Flow|A-AZD7325 2 mg|AZD7325 2 mg BID
327240|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327241|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327242|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327243|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327244|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327245|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327246|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327247|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327248|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327249|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327250|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327251|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327252|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327253|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327254|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327255|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327256|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327257|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327258|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327259|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327260|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327261|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327262|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327263|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
327264|NCT00812331|E1|Reported Event|Total|Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
327265|NCT00812253|B3|Baseline|Total|Total of all reporting groups
327266|NCT00812253|B2|Baseline|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327267|NCT00812253|B1|Baseline|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327268|NCT00812253|P2|Participant Flow|Subcutaneous Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327269|NCT00812253|P1|Participant Flow|Intravenous Insulin (IV)|Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327270|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327271|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327272|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327273|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327274|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327275|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327276|NCT00812253|E2|Reported Event|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
327277|NCT00812253|E1|Reported Event|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
327278|NCT00812110|B1|Baseline|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
327279|NCT00812110|P1|Participant Flow|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
327280|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
327281|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
327282|NCT00812110|E1|Reported Event|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
327283|NCT00812097|B5|Baseline|Total|Total of all reporting groups
327284|NCT00812097|B4|Baseline|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327285|NCT00812097|B3|Baseline|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327329|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
327453|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327286|NCT00812097|B2|Baseline|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327287|NCT00812097|B1|Baseline|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327288|NCT00812097|P4|Participant Flow|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327289|NCT00812097|P3|Participant Flow|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327290|NCT00812097|P2|Participant Flow|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327291|NCT00812097|P1|Participant Flow|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327292|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327293|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327294|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327295|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327296|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327297|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327541|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327298|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327299|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327300|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327301|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327302|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327303|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327304|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327305|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327306|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327307|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327308|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327309|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327542|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327310|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327311|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327312|NCT00812097|E4|Reported Event|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327313|NCT00812097|E3|Reported Event|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327314|NCT00812097|E2|Reported Event|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327315|NCT00812097|E1|Reported Event|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
327316|NCT00812006|B4|Baseline|Total|Total of all reporting groups
327317|NCT00812006|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
327318|NCT00812006|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
327319|NCT00812006|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
327320|NCT00812006|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
327321|NCT00812006|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
327322|NCT00812006|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
327323|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
327324|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
327325|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
327326|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
327327|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
327328|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
327450|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327330|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
327331|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
327332|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
327333|NCT00812006|E2|Reported Event|Placebo|"Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
327334|NCT00812006|E1|Reported Event|Rizatriptan|"Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
327335|NCT00811954|B4|Baseline|Total|Total of all reporting groups
327336|NCT00811954|B3|Baseline|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327337|NCT00811954|B2|Baseline|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327338|NCT00811954|B1|Baseline|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327339|NCT00811954|P3|Participant Flow|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327340|NCT00811954|P2|Participant Flow|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327341|NCT00811954|P1|Participant Flow|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327342|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327343|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327344|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327345|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327346|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327347|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327348|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327349|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327350|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327451|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
329147|NCT00808249|O4|Outcome|D-Placebo|Placebo
327351|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327352|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327353|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327354|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327355|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327356|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327357|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327358|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327359|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327360|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327361|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327362|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327363|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327364|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327365|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327366|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327367|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327368|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327369|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327370|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327371|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327372|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327373|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327374|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327375|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327376|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327377|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327378|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327379|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327380|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327381|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327382|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327383|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327384|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327385|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327386|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327387|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327388|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327389|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327390|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327391|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327392|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327393|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327394|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327395|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327452|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327396|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327397|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327398|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327399|NCT00811954|E3|Reported Event|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
327400|NCT00811954|E2|Reported Event|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
327401|NCT00811954|E1|Reported Event|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
327402|NCT00811941|B3|Baseline|Total|Total of all reporting groups
327403|NCT00811941|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327404|NCT00811941|B1|Baseline|Placebo|as-needed use, tablets, orally, 52 weeks
327405|NCT00811941|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327406|NCT00811941|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 52 weeks
327407|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327408|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327409|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327410|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327411|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327412|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327413|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327414|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327415|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327416|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327417|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327418|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327419|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327420|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327421|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327422|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327423|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327424|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327425|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327426|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327427|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327428|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327429|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327430|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327431|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327432|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327433|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327434|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327435|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327436|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327437|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327438|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
327439|NCT00811941|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
327440|NCT00811941|E1|Reported Event|Placebo|as-needed use, tablets, orally, 52 weeks
327441|NCT00811928|B3|Baseline|Total|Total of all reporting groups
327442|NCT00811928|B2|Baseline|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327443|NCT00811928|B1|Baseline|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327444|NCT00811928|P2|Participant Flow|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327445|NCT00811928|P1|Participant Flow|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327446|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327447|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327448|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327449|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327454|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327455|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327456|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327457|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327458|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327459|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327460|NCT00811928|E2|Reported Event|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
327461|NCT00811928|E1|Reported Event|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
327462|NCT00811850|B1|Baseline|All Patients|All patients in the study
327463|NCT00811850|P1|Participant Flow|All Patients|This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
327464|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327465|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327466|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327467|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327468|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327469|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327470|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327471|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327472|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327473|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327474|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327475|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327476|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327477|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327478|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327479|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327480|NCT00811850|E2|Reported Event|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327481|NCT00811850|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
327482|NCT00811798|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
327483|NCT00811798|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
327484|NCT00811798|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
327485|NCT00811798|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
327486|NCT00811733|B3|Baseline|Total|Total of all reporting groups
327487|NCT00811733|B2|Baseline|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327488|NCT00811733|B1|Baseline|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327489|NCT00811733|P2|Participant Flow|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327490|NCT00811733|P1|Participant Flow|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327491|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327492|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327493|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327494|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327495|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327543|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327544|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327545|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327546|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327547|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327548|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327549|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
329148|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
327496|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327497|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327498|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327499|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327500|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327501|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327502|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327503|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327504|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327505|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327506|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327507|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327508|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327509|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327510|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327511|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327512|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327513|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327514|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327515|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327516|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327517|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327518|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327519|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327520|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327521|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327522|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327523|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327524|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327525|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327526|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327527|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327528|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327529|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327530|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327531|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327532|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327533|NCT00811733|E2|Reported Event|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
327534|NCT00811733|E1|Reported Event|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
327535|NCT00811720|B3|Baseline|Total|Total of all reporting groups
327536|NCT00811720|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327537|NCT00811720|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
327538|NCT00811720|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327539|NCT00811720|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
327540|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327552|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
327553|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
327554|NCT00811720|E2|Reported Event|Nalmefene 18.06 mg|
327555|NCT00811720|E1|Reported Event|Placebo|
327556|NCT00811655|B1|Baseline|Pre-OP SRS|"SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
327557|NCT00811655|P1|Participant Flow|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
327558|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327559|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327560|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327561|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327562|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327563|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327564|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327565|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327566|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
327567|NCT00811655|E1|Reported Event|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
327568|NCT00811642|B1|Baseline|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327569|NCT00811642|P1|Participant Flow|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327570|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327571|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327572|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327573|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327574|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327575|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327576|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
327577|NCT00811642|E1|Reported Event|POSACONAZOLE|400mg oral suspension BID for 12 weeks
327578|NCT00811590|B1|Baseline|All Patients|All patients enrolled/eligible.
327579|NCT00811590|P1|Participant Flow|All Patients|All patients enrolled/eligible.
327580|NCT00811590|O1|Outcome|All Patients|All enrolled/eligible patients.
327581|NCT00811590|E1|Reported Event|All Patients|All enrolled/eligible patients.
327582|NCT00811577|B3|Baseline|Total|Total of all reporting groups
327583|NCT00811577|B2|Baseline|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
327584|NCT00811577|B1|Baseline|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
327585|NCT00811577|P2|Participant Flow|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
327586|NCT00811577|P1|Participant Flow|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
327587|NCT00811577|O3|Outcome|Alpha SMA Results for 10 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327588|NCT00811577|O2|Outcome|Alpha SMA Results for 3 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327589|NCT00811577|O1|Outcome|Alpha SMA Results for Placebo Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327590|NCT00811577|O9|Outcome|Collagen Fiber Orientation Results for 10 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327591|NCT00811577|O8|Outcome|Collagen Fiber Orientation Results for 3 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327665|NCT00811434|O2|Outcome|Placebo|1.5 ml/kg day po of sugar water placebo for three months
327666|NCT00811434|O1|Outcome|Lactulose|3 months of Lactulose therapy based on pt. weight
327592|NCT00811577|O7|Outcome|Collagen Fiber Orientation Results for Placebo Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327593|NCT00811577|O6|Outcome|Collagen Fiber Maturity Results for 10 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327594|NCT00811577|O5|Outcome|Collagen Fiber Maturity Results for 3 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327595|NCT00811577|O4|Outcome|Collagen Fiber Maturity Results for Placebo Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327596|NCT00811577|O3|Outcome|Collagen Fiber Density Results for 10 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327597|NCT00811577|O2|Outcome|Collagen Fiber Density Results for 3 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327598|NCT00811577|O1|Outcome|Collagen Fiber Density Results for Placebo Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327599|NCT00811577|O9|Outcome|Scar Total Volume for 10 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327600|NCT00811577|O8|Outcome|Scar Total Volume for 3 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327601|NCT00811577|O7|Outcome|Scar Total Volume for Placebo Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327602|NCT00811577|O6|Outcome|Scar Negative Volume for 10 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327603|NCT00811577|O5|Outcome|Scar Negative Volume for 3 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327604|NCT00811577|O4|Outcome|Scar Negative Volume for Placebo Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327605|NCT00811577|O3|Outcome|Scar Positive Volume for 10 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327606|NCT00811577|O2|Outcome|Scar Positive Volume for 3 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327607|NCT00811577|O1|Outcome|Scar Positive Volume for Placebo Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327608|NCT00811577|O12|Outcome|Scar Maximum Elevation for 10 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327609|NCT00811577|O11|Outcome|Scar Maximum Elevation for 3 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327610|NCT00811577|O10|Outcome|Scar Maximum Elevation for Placebo Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327611|NCT00811577|O9|Outcome|Scar Minimum Elevation for 10 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327612|NCT00811577|O8|Outcome|Scar Minimum Elevation for 3 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327613|NCT00811577|O7|Outcome|Scar Minimum Elevation for Placebo Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery.
327614|NCT00811577|O6|Outcome|Scar Width for 10 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327615|NCT00811577|O5|Outcome|Scar Width for 3 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327616|NCT00811577|O4|Outcome|Scar Width for Placebo Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327617|NCT00811577|O3|Outcome|Scar Length for 10 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327667|NCT00811434|O1|Outcome|All Randomized Participants|
327668|NCT00811434|O1|Outcome|All Randomized Participants|
327618|NCT00811577|O2|Outcome|Scar Length for 3 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327619|NCT00811577|O1|Outcome|Scar Length for Placebo Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327620|NCT00811577|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327621|NCT00811577|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327622|NCT00811577|O4|Outcome|Rater 2 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327623|NCT00811577|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327624|NCT00811577|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327625|NCT00811577|O1|Outcome|Rater 1 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327626|NCT00811577|O6|Outcome|OSAS Results for 10 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327627|NCT00811577|O5|Outcome|OSAS Results for 3 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327628|NCT00811577|O4|Outcome|OSAS Results for Placebo Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327629|NCT00811577|O3|Outcome|PSAS Results for 10 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
327630|NCT00811577|O2|Outcome|PSAS Results for 3 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
327631|NCT00811577|O1|Outcome|PSAS Results for Placebo Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
327632|NCT00811577|E2|Reported Event|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
327633|NCT00811577|E1|Reported Event|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
327634|NCT00811564|B3|Baseline|Total|Total of all reporting groups
327635|NCT00811564|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
327636|NCT00811564|B1|Baseline|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
327637|NCT00811564|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
327638|NCT00811564|P1|Participant Flow|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
327639|NCT00811564|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
327640|NCT00811564|O1|Outcome|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
327641|NCT00811564|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
327642|NCT00811564|E1|Reported Event|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
327643|NCT00811473|B3|Baseline|Total|Total of all reporting groups
327644|NCT00811473|B2|Baseline|Placebo|Matching placebo
327645|NCT00811473|B1|Baseline|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327646|NCT00811473|P2|Participant Flow|Placebo|Matching placebo
327647|NCT00811473|P1|Participant Flow|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327648|NCT00811473|O2|Outcome|Placebo|Matching placebo
327649|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327650|NCT00811473|O2|Outcome|Placebo|Matching placebo
327651|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327652|NCT00811473|O2|Outcome|Placebo|Matching placebo
327653|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327654|NCT00811473|O2|Outcome|Placebo|Matching placebo
327655|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327656|NCT00811473|O2|Outcome|Placebo|Matching placebo
327657|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327658|NCT00811473|O2|Outcome|Placebo|Matching placebo
327659|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327660|NCT00811473|E2|Reported Event|Placebo|Matching placebo
327661|NCT00811473|E1|Reported Event|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
327662|NCT00811434|B1|Baseline|All Participants|all aprticipants who were randomized to receive treatment
327663|NCT00811434|P2|Participant Flow|Placebo First, Then Lactulose|Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
327664|NCT00811434|P1|Participant Flow|Lactulose First, Then Placebo|Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day
327669|NCT00811434|E2|Reported Event|Placebo|1.5 ml/kg day po of sugar water placebo for three months
327670|NCT00811434|E1|Reported Event|Lactulose|3 months of Lactulose therapy based on pt. weight
327671|NCT00811395|B7|Baseline|Total|Total of all reporting groups
327672|NCT00811395|B6|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327673|NCT00811395|B5|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327674|NCT00811395|B4|Baseline|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327675|NCT00811395|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327676|NCT00811395|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327677|NCT00811395|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327678|NCT00811395|P6|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327679|NCT00811395|P5|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327680|NCT00811395|P4|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327681|NCT00811395|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327682|NCT00811395|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327683|NCT00811395|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327684|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327685|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327686|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327687|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327688|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327689|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327690|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327691|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327692|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327693|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327694|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327695|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327696|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327697|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327698|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327699|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327700|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327701|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327702|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327703|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327704|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327705|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327706|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327707|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327708|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327709|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327710|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327711|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327712|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327713|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327714|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327715|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327716|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327717|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327718|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327719|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327720|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327721|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327722|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327723|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327724|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327725|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327726|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
327727|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
327728|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
327729|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327730|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327731|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327732|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
327733|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
327734|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
327735|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327736|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327737|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327738|NCT00811395|E6|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
327739|NCT00811395|E5|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
327740|NCT00811395|E4|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
327741|NCT00811395|E3|Reported Event|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
327742|NCT00811395|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
327743|NCT00811395|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
327744|NCT00811252|B4|Baseline|Total|Total of all reporting groups
327745|NCT00811252|B3|Baseline|Duloxetine 60 mg|encapsulated tablets; daily; orally
327746|NCT00811252|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327747|NCT00811252|B1|Baseline|Placebo|capsules; daily; orally
327748|NCT00811252|P3|Participant Flow|Duloxetine 60 mg|encapsulated tablets; daily; orally
327749|NCT00811252|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327750|NCT00811252|P1|Participant Flow|Placebo|capsules; daily; orally
327751|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327752|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327753|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327754|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327755|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327756|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327757|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327758|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327759|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327760|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327761|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327762|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327763|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327764|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327765|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327766|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327767|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327768|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327769|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327770|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327771|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327772|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327773|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327774|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327775|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327776|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327777|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327778|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327779|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327780|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327781|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327782|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327783|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327784|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327785|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327787|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
327788|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
327789|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
327790|NCT00811252|E3|Reported Event|Duloxetine 60 mg|
327791|NCT00811252|E2|Reported Event|Vortioxetine 5 mg|
327792|NCT00811252|E1|Reported Event|Placebo|
327793|NCT00811135|B1|Baseline|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327794|NCT00811135|P1|Participant Flow|Trastuzumab + Bevacizumab + Capecitabine|Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram [mg/kg]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327795|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327796|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327797|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327798|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327799|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327800|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327801|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327802|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327803|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327804|NCT00811135|E1|Reported Event|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
327805|NCT00811070|B7|Baseline|Total|Total of all reporting groups
327806|NCT00811070|B6|Baseline|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327807|NCT00811070|B5|Baseline|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
328007|NCT00810511|E2|Reported Event|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
327808|NCT00811070|B4|Baseline|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327809|NCT00811070|B3|Baseline|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327810|NCT00811070|B2|Baseline|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327811|NCT00811070|B1|Baseline|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327812|NCT00811070|P6|Participant Flow|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327813|NCT00811070|P5|Participant Flow|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327814|NCT00811070|P4|Participant Flow|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327815|NCT00811070|P3|Participant Flow|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327816|NCT00811070|P2|Participant Flow|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327817|NCT00811070|P1|Participant Flow|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327818|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327819|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327820|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327821|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327822|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327823|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327824|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327825|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
328075|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
327826|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327827|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327828|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327829|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327830|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327831|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327832|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327833|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327834|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327835|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327836|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327837|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327838|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327839|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327840|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327841|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327842|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327843|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327844|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
327845|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327846|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327847|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327848|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327849|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327850|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327851|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327852|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327853|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327854|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327855|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327856|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327857|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327858|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327859|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
328008|NCT00810511|E1|Reported Event|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
328009|NCT00810368|B3|Baseline|Total|Total of all reporting groups
327860|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327861|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327862|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327863|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327864|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327865|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327866|NCT00811070|O1|Outcome|All Treated Participants (Part 1 )|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
327867|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
327868|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327869|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
327870|NCT00811070|E3|Reported Event|Total Population|Total participants who were second-line or third-line chronic myelogenous leukemia (CML).
327871|NCT00811070|E2|Reported Event|Exploratory Third-line|All participants who received bosutinib 500 mg orally once daily in third-line chronic myelogenous leukemia (CML), participants were with imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant.
327872|NCT00811070|E1|Reported Event|Total Second-line|All participants who received bosutinib orally once daily in second-line chronic myelogenous leukemia (CML), who were imatinib resistant/refractory/intolerant.
327873|NCT00811057|B4|Baseline|Total|Total of all reporting groups
327874|NCT00811057|B3|Baseline|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
327875|NCT00811057|B2|Baseline|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
327876|NCT00811057|B1|Baseline|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
327877|NCT00811057|P3|Participant Flow|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
327878|NCT00811057|P2|Participant Flow|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
328073|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328074|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
327879|NCT00811057|P1|Participant Flow|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
327880|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
327881|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
327882|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
327883|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
327884|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
327885|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
327886|NCT00811057|E3|Reported Event|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
327887|NCT00811057|E2|Reported Event|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
327888|NCT00811057|E1|Reported Event|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
327889|NCT00811018|B1|Baseline|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327890|NCT00811018|P1|Participant Flow|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327891|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327892|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327893|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327894|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327895|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327896|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327897|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327898|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327899|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327900|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327901|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327902|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327903|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327904|NCT00811018|E1|Reported Event|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
327905|NCT00810901|B3|Baseline|Total|Total of all reporting groups
327906|NCT00810901|B2|Baseline|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
327950|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327907|NCT00810901|B1|Baseline|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
327908|NCT00810901|P2|Participant Flow|Alcohol Prevention|"Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
327909|NCT00810901|P1|Participant Flow|Organ Donor|"Intervention used a digital video disk (DVD), text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
327910|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
327911|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
327912|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
327913|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
327914|NCT00810901|E2|Reported Event|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
327915|NCT00810901|E1|Reported Event|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
327916|NCT00810771|B4|Baseline|Total|Total of all reporting groups
327917|NCT00810771|B3|Baseline|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
327918|NCT00810771|B2|Baseline|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
327919|NCT00810771|B1|Baseline|Preference-tailored (PT) Intervention|Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
327920|NCT00810771|P3|Participant Flow|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
327921|NCT00810771|P2|Participant Flow|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
327922|NCT00810771|P1|Participant Flow|Preference-tailored (PT) Intervention|"Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.~Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
327923|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
327924|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
327925|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
327926|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
327951|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327927|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
327928|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
327929|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
327930|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
327931|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
327932|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
327933|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
327934|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
327935|NCT00810771|O3|Outcome|Usual Care|"Usual Care - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening."
327936|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
327937|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
327938|NCT00810771|E3|Reported Event|Usual Care|"Usual Care - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm."
327939|NCT00810771|E2|Reported Event|Standard Information (SI) Intervention|Standard information (SI) intervention
327940|NCT00810771|E1|Reported Event|Preference-tailored (PT) Intervention|Preference-tailored (PT) intervention
327941|NCT00810693|B4|Baseline|Total|Total of all reporting groups
327942|NCT00810693|B3|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327943|NCT00810693|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327944|NCT00810693|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327945|NCT00810693|P3|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327946|NCT00810693|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327947|NCT00810693|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327948|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327949|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
328004|NCT00810511|P1|Participant Flow|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
327952|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327953|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327954|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327955|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327956|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327957|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327958|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327959|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327960|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327961|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327962|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327963|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327964|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327965|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327966|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327967|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327968|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327969|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327970|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327971|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327972|NCT00810693|E3|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
327973|NCT00810693|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327974|NCT00810693|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
327975|NCT00810641|B4|Baseline|Total|Total of all reporting groups
327976|NCT00810641|B3|Baseline|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
327977|NCT00810641|B2|Baseline|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
327978|NCT00810641|B1|Baseline|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
327979|NCT00810641|P3|Participant Flow|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
327980|NCT00810641|P2|Participant Flow|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
327981|NCT00810641|P1|Participant Flow|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
327982|NCT00810641|O3|Outcome|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
327983|NCT00810641|O2|Outcome|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
327984|NCT00810641|O1|Outcome|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
327985|NCT00810641|E3|Reported Event|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
327986|NCT00810641|E2|Reported Event|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
327987|NCT00810641|E1|Reported Event|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
328005|NCT00810511|O2|Outcome|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
328006|NCT00810511|O1|Outcome|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
329149|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
327988|NCT00810602|B1|Baseline|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327989|NCT00810602|P2|Participant Flow|Phase 2|100 mg was selected as the Phase 2 dose. Participants were administered Vorinostat, 100 mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
327990|NCT00810602|P1|Participant Flow|Phase 1|In the Phase 1 portion of the study, participants were administered Vorinostat, either 100 mg or 200mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
327991|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327992|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327993|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327994|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327995|NCT00810602|E1|Reported Event|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
327996|NCT00810576|B1|Baseline|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
327997|NCT00810576|P1|Participant Flow|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
327998|NCT00810576|O1|Outcome|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
327999|NCT00810576|E1|Reported Event|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
328000|NCT00810511|B3|Baseline|Total|Total of all reporting groups
328001|NCT00810511|B2|Baseline|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
328002|NCT00810511|B1|Baseline|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
328003|NCT00810511|P2|Participant Flow|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
328010|NCT00810368|B2|Baseline|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328011|NCT00810368|B1|Baseline|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328012|NCT00810368|P2|Participant Flow|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328013|NCT00810368|P1|Participant Flow|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328014|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328015|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328016|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328017|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328018|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328019|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328020|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328021|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328022|NCT00810368|O2|Outcome|Placebo Control Group|"Placebo control group~Placebo: Microcrystalline cellulose placebo tablets x2 daily"
328023|NCT00810368|O1|Outcome|Carnosine Treatment Group|"Carnosine treatment group~Carnosine: 500mg Carnosine x2 daily"
328024|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328025|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328026|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328027|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328028|NCT00810368|E2|Reported Event|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
328029|NCT00810368|E1|Reported Event|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
328030|NCT00810355|B4|Baseline|Total|Total of all reporting groups
328031|NCT00810355|B3|Baseline|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328032|NCT00810355|B2|Baseline|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
328033|NCT00810355|B1|Baseline|Support Group|"Support group~Support Group: General support and problem solving for work activity"
328034|NCT00810355|P3|Participant Flow|Cognitive Behavior Therapy and Cognitive Remediation|"Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328035|NCT00810355|P2|Participant Flow|Cognitive Behavior Therapy|Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
328036|NCT00810355|P1|Participant Flow|Support Group|Support Group: General support and problem solving for work activity
328037|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328038|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
328039|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
328040|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328041|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
328042|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
328043|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328044|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
328045|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
328046|NCT00810355|E3|Reported Event|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
328047|NCT00810355|E2|Reported Event|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
328048|NCT00810355|E1|Reported Event|Support Group|"Support group~Support Group: General support and problem solving for work activity"
328049|NCT00810342|B3|Baseline|Total|Total of all reporting groups
328050|NCT00810342|B2|Baseline|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
328051|NCT00810342|B1|Baseline|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
328052|NCT00810342|P2|Participant Flow|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
328053|NCT00810342|P1|Participant Flow|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
328054|NCT00810342|O2|Outcome|2 - Physical Activity Standard|"Standard Website resources / information on physical activity~physical activity standard: standard print and website information on how to become more active"
328055|NCT00810342|O1|Outcome|1- Physical Activity Tailored|"Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
328056|NCT00810342|O2|Outcome|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
328057|NCT00810342|O1|Outcome|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
328058|NCT00810342|E2|Reported Event|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
328059|NCT00810342|E1|Reported Event|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
328060|NCT00810303|B1|Baseline|Study Group|whole study group: 12 healthy subjects
328061|NCT00810303|P1|Participant Flow|Study Group|whole study group: 12 healthy subjects
328062|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328063|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328064|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328065|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328066|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328067|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328068|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328069|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328070|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328071|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328072|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328076|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328077|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328078|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328079|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
328080|NCT00810303|E5|Reported Event|Ezetimibe and Efavirenz Multiple Dose|
328081|NCT00810303|E4|Reported Event|Ezetimibe Multiple Dose and Efavirenz Single Dose|
328082|NCT00810303|E3|Reported Event|Ezetimibe Alone Multiple Dose|
328083|NCT00810303|E2|Reported Event|Efavirenz Alone Single Dose|
328084|NCT00810303|E1|Reported Event|Study Group|whole study group: 12 healthy subjects
328085|NCT00810277|B1|Baseline|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328086|NCT00810277|P1|Participant Flow|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328087|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328088|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328089|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328090|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328091|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328092|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328093|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328094|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328095|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328096|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328097|NCT00810277|E1|Reported Event|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
328098|NCT00810199|B3|Baseline|Total|Total of all reporting groups
328099|NCT00810199|B2|Baseline|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328100|NCT00810199|B1|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328101|NCT00810199|P2|Participant Flow|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328102|NCT00810199|P1|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328112|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
328103|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328104|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328105|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328106|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328107|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328108|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328109|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328110|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328111|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added
329150|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
328113|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
328114|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
328115|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328116|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328117|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328118|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328119|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328120|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328121|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328122|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328208|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328123|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328124|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328125|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328126|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328127|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328128|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328129|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328130|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328209|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328210|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
329151|NCT00808249|O4|Outcome|D-Placebo|Placebo
328131|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328132|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328133|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328134|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328135|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328136|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328137|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328138|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328211|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328212|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
329152|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
328139|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328140|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328141|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328142|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328143|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328144|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328145|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328146|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328213|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328214|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
329153|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
328147|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328148|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328149|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328150|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328151|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328152|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328153|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
328154|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
328155|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
328156|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
328157|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328158|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328159|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328160|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328161|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328162|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328163|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328164|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328165|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328215|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328216|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
329154|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
328166|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328167|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328168|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328169|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328170|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328171|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328172|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328173|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
328174|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
328175|NCT00810199|E2|Reported Event|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
328250|NCT00810043|B1|Baseline|Curette-First|Use of the curette prior to use of the inflatable bone tamps
328176|NCT00810199|E1|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
328177|NCT00810108|B3|Baseline|Total|Total of all reporting groups
328178|NCT00810108|B2|Baseline|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
328179|NCT00810108|B1|Baseline|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
328180|NCT00810108|P2|Participant Flow|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
328181|NCT00810108|P1|Participant Flow|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
328182|NCT00810108|O2|Outcome|All Subjects Taking Crushed Tablets|Lopinavir AUC from all subjects taking the crushed tablet
328183|NCT00810108|O1|Outcome|All Subjects Taking Whole Tablets|Lopinavir AUC from all subjects taking the whole tablet
328184|NCT00810108|E1|Reported Event|All Subjects|Data from all subjects combined
328185|NCT00810095|B1|Baseline|Treatment Group|All participants treated with the Test System
328186|NCT00810095|P1|Participant Flow|MindFrame System Treatment Group|All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
328187|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
328188|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
328189|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
328190|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
328191|NCT00810095|E1|Reported Event|Treatment Group|All participants treated with the Test System
328192|NCT00810082|B3|Baseline|Total|Total of all reporting groups
328193|NCT00810082|B2|Baseline|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
328194|NCT00810082|B1|Baseline|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
328195|NCT00810082|P2|Participant Flow|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
328196|NCT00810082|P1|Participant Flow|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
328197|NCT00810082|O2|Outcome|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
328198|NCT00810082|O1|Outcome|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
328199|NCT00810082|E2|Reported Event|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
328200|NCT00810082|E1|Reported Event|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
328201|NCT00810069|B3|Baseline|Total|Total of all reporting groups
328202|NCT00810069|B2|Baseline|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328203|NCT00810069|B1|Baseline|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328204|NCT00810069|P3|Participant Flow|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328205|NCT00810069|P2|Participant Flow|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328206|NCT00810069|P1|Participant Flow|Escitalopram (Acute Treatment)|Escitalopram 10 milligrams (mg) per day for 4 weeks
328207|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328217|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328218|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328219|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328220|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328221|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328222|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328223|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328224|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328225|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328226|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328227|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328228|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328229|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328230|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328231|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328232|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328233|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328234|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328235|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328236|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328237|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328238|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328239|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328240|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328241|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
328242|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
328243|NCT00810069|E5|Reported Event|Delayed Intervention Non-Responders|Duloxetine 60 or 120 mg per day for 8 weeks.
328244|NCT00810069|E4|Reported Event|Delayed Intervention Responders|Escitalopram 10 to 20 mg per day for 8 weeks.
328245|NCT00810069|E3|Reported Event|Early Intervention (Double Blind)|Duloxetine flexible dose (60 or 120 milligram [mg] daily) for 12 weeks.
328246|NCT00810069|E2|Reported Event|Delayed Intervention (Double Blind)|Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
328247|NCT00810069|E1|Reported Event|Escitalopram (Acute Treatment)|Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
328248|NCT00810043|B3|Baseline|Total|Total of all reporting groups
328249|NCT00810043|B2|Baseline|IBT-First|Use of the inflatable bone tamps prior to using the curette
328251|NCT00810043|P3|Participant Flow|Non-treated Patients|Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
328252|NCT00810043|P2|Participant Flow|IBT-First|Use of the inflatable bone tamps prior to using the curette
328253|NCT00810043|P1|Participant Flow|Curette-First|Use of the curette prior to use of the inflatable bone tamps
328254|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328255|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328256|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328257|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328258|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328259|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328260|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328261|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328262|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328263|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328264|NCT00810043|O1|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328265|NCT00810043|O2|Outcome|IBT-First|Use of the inflatable bone tamps prior to using the curette
328266|NCT00810043|O1|Outcome|Curette-First|Use of the curette prior to use of the inflatable bone tamps
328267|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
328268|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
328269|NCT00810043|E2|Reported Event|IBT-First|Use of the inflatable bone tamps prior to using the curette
328270|NCT00810043|E1|Reported Event|Curette-First|Use of the curette prior to use of the inflatable bone tamps
328271|NCT00809965|B4|Baseline|Total|Total of all reporting groups
328272|NCT00809965|B3|Baseline|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328273|NCT00809965|B2|Baseline|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328274|NCT00809965|B1|Baseline|Placebo|One placebo tablet twice daily
328275|NCT00809965|P3|Participant Flow|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328276|NCT00809965|P2|Participant Flow|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328277|NCT00809965|P1|Participant Flow|Placebo|One placebo tablet twice daily
328278|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328279|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328280|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
328281|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328282|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328283|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
328284|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328285|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328286|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
328287|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328288|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328289|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
328290|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328291|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328292|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
328293|NCT00809965|E3|Reported Event|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
328294|NCT00809965|E2|Reported Event|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
328295|NCT00809965|E1|Reported Event|Placebo|One placebo tablet twice daily
328296|NCT00809926|B3|Baseline|Total|Total of all reporting groups
328297|NCT00809926|B2|Baseline|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328298|NCT00809926|B1|Baseline|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328299|NCT00809926|P2|Participant Flow|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328300|NCT00809926|P1|Participant Flow|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328301|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328302|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328303|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328304|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328399|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328305|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328306|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328307|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328308|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328309|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328310|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328311|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328312|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328313|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328314|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328315|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328316|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328317|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328318|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328319|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
328320|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
328321|NCT00809926|E2|Reported Event|Valsartan|Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
328322|NCT00809926|E1|Reported Event|Valsartan/ Aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
328323|NCT00809848|B6|Baseline|Total|Total of all reporting groups
328324|NCT00809848|B5|Baseline|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
328325|NCT00809848|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
328326|NCT00809848|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
328327|NCT00809848|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
328328|NCT00809848|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
328329|NCT00809848|P5|Participant Flow|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
328330|NCT00809848|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
328331|NCT00809848|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
328332|NCT00809848|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
328333|NCT00809848|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
328334|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
328335|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
328336|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
328337|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
328338|NCT00809848|O1|Outcome|AGN 210669 Non-preserved Ophthalmic Solution, 0.075%|AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
328339|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
328340|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
328341|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
328342|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
328343|NCT00809848|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
328344|NCT00809848|E5|Reported Event|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
328345|NCT00809848|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
328346|NCT00809848|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
328347|NCT00809848|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
328348|NCT00809848|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
328349|NCT00809809|B3|Baseline|Total|Total of all reporting groups
328350|NCT00809809|B2|Baseline|Placebo Treatment|Placebo medication - Swabs identical to medication group
328351|NCT00809809|B1|Baseline|Active Treatment|Active medication - Zinc Swabs
328352|NCT00809809|P2|Participant Flow|Placebo Treatment|Placebo medication - Swabs identical to medication group
328353|NCT00809809|P1|Participant Flow|Active Treatment|Active medication - Zinc Swabs
328354|NCT00809809|O2|Outcome|Placebo Treatment|Placebo medication - Swabs identical to medication group
328355|NCT00809809|O1|Outcome|Active Treatment|Active medication - Zinc Swabs
328356|NCT00809809|E2|Reported Event|Placebo Treatment|Placebo medication - Swabs identical to medication group
328357|NCT00809809|E1|Reported Event|Active Treatment|Active medication - Zinc Swabs
328358|NCT00809757|B4|Baseline|Total|Total of all reporting groups
328359|NCT00809757|B3|Baseline|Levalbuterol UDV|Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328360|NCT00809757|B2|Baseline|Levalbuterol MDI|Levalbuterol MDI TID
328361|NCT00809757|B1|Baseline|Placebo|Placebo Placebo MDI TID
328362|NCT00809757|P3|Participant Flow|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
328363|NCT00809757|P2|Participant Flow|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
328364|NCT00809757|P1|Participant Flow|Placebo|Placebo: Placebo (2 actuations)
328365|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328366|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328367|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328368|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328369|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328370|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328371|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328372|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328373|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328374|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328375|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328376|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328377|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328378|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328379|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328380|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328381|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328382|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328383|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328384|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328385|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
328386|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328387|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328388|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328389|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328390|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328391|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328392|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328393|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328394|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
328395|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328396|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328397|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328398|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328400|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328401|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328402|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328403|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328404|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328405|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328406|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328407|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328408|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328409|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328410|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328411|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328412|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328413|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328414|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328415|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328416|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328417|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328418|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328419|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328420|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328421|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328422|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328423|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328424|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328425|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
328426|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328427|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
328428|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328429|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328430|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
328431|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
328432|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328433|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328434|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
328435|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328436|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328437|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328438|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328439|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
328440|NCT00809757|O3|Outcome|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
328441|NCT00809757|O2|Outcome|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
328442|NCT00809757|O1|Outcome|Placebo|Placebo: Placebo (2 actuations)
328443|NCT00809757|E3|Reported Event|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
328444|NCT00809757|E2|Reported Event|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
328445|NCT00809757|E1|Reported Event|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
328446|NCT00809614|B3|Baseline|Total|Total of all reporting groups
328447|NCT00809614|B2|Baseline|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328448|NCT00809614|B1|Baseline|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328449|NCT00809614|P2|Participant Flow|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328450|NCT00809614|P1|Participant Flow|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328451|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328452|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328453|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328454|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328455|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328456|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328457|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328458|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328459|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328460|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328461|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328462|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328463|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328464|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328465|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328466|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328467|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328468|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328469|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328470|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328471|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328472|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328473|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328474|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328475|NCT00809614|E2|Reported Event|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
328476|NCT00809614|E1|Reported Event|AIN457 2x10mg/kg|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
328477|NCT00809523|B3|Baseline|Total|Total of all reporting groups
328478|NCT00809523|B2|Baseline|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328479|NCT00809523|B1|Baseline|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328480|NCT00809523|P2|Participant Flow|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328481|NCT00809523|P1|Participant Flow|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328482|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328483|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328484|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328485|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328486|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328487|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328488|NCT00809523|E2|Reported Event|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
328489|NCT00809523|E1|Reported Event|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
328490|NCT00809471|B4|Baseline|Total|Total of all reporting groups
328491|NCT00809471|B3|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328492|NCT00809471|B2|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328493|NCT00809471|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328494|NCT00809471|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328495|NCT00809471|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328496|NCT00809471|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328497|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328498|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328499|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328500|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328501|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328502|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328503|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328504|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328505|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328506|NCT00809471|E3|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
328507|NCT00809471|E2|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
328508|NCT00809471|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
328509|NCT00809458|B3|Baseline|Total|Total of all reporting groups
328510|NCT00809458|B2|Baseline|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
328511|NCT00809458|B1|Baseline|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
328512|NCT00809458|P2|Participant Flow|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
328513|NCT00809458|P1|Participant Flow|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
329155|NCT00808249|O4|Outcome|D-Placebo|Placebo
328514|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
328515|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
328516|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
328517|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
328518|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
328519|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
328520|NCT00809458|E2|Reported Event|Arm 2|"Placebo (same vehicle as used for vitamin E)~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
328521|NCT00809458|E1|Reported Event|Arm 1 (Vitamin E)|"Vitamin E~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
328522|NCT00809445|B4|Baseline|Total|Total of all reporting groups
328523|NCT00809445|B3|Baseline|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328524|NCT00809445|B2|Baseline|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328525|NCT00809445|B1|Baseline|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328526|NCT00809445|P3|Participant Flow|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328527|NCT00809445|P2|Participant Flow|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328528|NCT00809445|P1|Participant Flow|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328529|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328530|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328531|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328532|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328533|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328534|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328535|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328536|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328537|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328538|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328539|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328540|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328541|NCT00809445|E3|Reported Event|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
328542|NCT00809445|E2|Reported Event|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
328543|NCT00809445|E1|Reported Event|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
328544|NCT00809328|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328545|NCT00809328|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328585|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/Kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328546|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328547|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328548|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328549|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328550|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328551|NCT00809328|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
328552|NCT00809276|B1|Baseline|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
328553|NCT00809276|P1|Participant Flow|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
328554|NCT00809276|O1|Outcome|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
328555|NCT00809276|E1|Reported Event|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
328556|NCT00809185|B1|Baseline|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
328557|NCT00809185|P1|Participant Flow|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
328558|NCT00809185|O1|Outcome|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
328559|NCT00809185|E1|Reported Event|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
328560|NCT00809159|B5|Baseline|Total|Total of all reporting groups
328561|NCT00809159|B4|Baseline|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328562|NCT00809159|B3|Baseline|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328563|NCT00809159|B2|Baseline|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328564|NCT00809159|B1|Baseline|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328565|NCT00809159|P6|Participant Flow|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328566|NCT00809159|P5|Participant Flow|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328567|NCT00809159|P4|Participant Flow|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328568|NCT00809159|P3|Participant Flow|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328569|NCT00809159|P2|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328570|NCT00809159|P1|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328571|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328572|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328573|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328574|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328575|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328576|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328577|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328578|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328579|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328580|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328581|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328582|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328583|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328584|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
329156|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
329157|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
328586|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328587|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328588|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328589|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328590|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328591|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328592|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328593|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328594|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328595|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328596|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328597|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328598|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328599|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328600|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328601|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328602|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328603|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328604|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328605|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328606|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328607|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328608|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328609|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328610|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328611|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328612|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328613|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328614|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328615|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328616|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328617|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328618|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328619|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328620|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328621|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328622|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328623|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328624|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328625|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328626|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
328627|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
328628|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
328629|NCT00809159|E4|Reported Event|Placebo|Placebo to AIN457A was administered intravenously as a single dose
328630|NCT00809159|E3|Reported Event|AIN457 2x0.1mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328631|NCT00809159|E2|Reported Event|AIN457 2x1.0mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328632|NCT00809159|E1|Reported Event|AIN457 2x10mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
328633|NCT00809146|B3|Baseline|Total|Total of all reporting groups
328634|NCT00809146|B2|Baseline|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
328635|NCT00809146|B1|Baseline|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
328636|NCT00809146|P2|Participant Flow|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
328637|NCT00809146|P1|Participant Flow|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
328638|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328639|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328640|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328641|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328642|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328643|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328644|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328645|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328646|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328647|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328648|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328649|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328650|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328651|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328652|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328653|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328654|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328655|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328656|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328657|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328658|NCT00809146|E2|Reported Event|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
328659|NCT00809146|E1|Reported Event|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
328660|NCT00809133|B15|Baseline|Total|Total of all reporting groups
328661|NCT00809133|B14|Baseline|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328662|NCT00809133|B13|Baseline|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328663|NCT00809133|B12|Baseline|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328664|NCT00809133|B11|Baseline|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
329158|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
328665|NCT00809133|B10|Baseline|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328666|NCT00809133|B9|Baseline|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328667|NCT00809133|B8|Baseline|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328668|NCT00809133|B7|Baseline|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328669|NCT00809133|B6|Baseline|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328670|NCT00809133|B5|Baseline|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328671|NCT00809133|B4|Baseline|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328672|NCT00809133|B3|Baseline|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328673|NCT00809133|B2|Baseline|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328674|NCT00809133|B1|Baseline|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328675|NCT00809133|P14|Participant Flow|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328676|NCT00809133|P13|Participant Flow|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328677|NCT00809133|P12|Participant Flow|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328678|NCT00809133|P11|Participant Flow|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328679|NCT00809133|P10|Participant Flow|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328680|NCT00809133|P9|Participant Flow|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328681|NCT00809133|P8|Participant Flow|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328682|NCT00809133|P7|Participant Flow|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328683|NCT00809133|P6|Participant Flow|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328684|NCT00809133|P5|Participant Flow|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328685|NCT00809133|P4|Participant Flow|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328686|NCT00809133|P3|Participant Flow|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
329159|NCT00808249|O4|Outcome|D-Placebo|Placebo
328687|NCT00809133|P2|Participant Flow|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328688|NCT00809133|P1|Participant Flow|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328689|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328690|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328691|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328692|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328693|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328694|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328695|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328696|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328697|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328698|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328699|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328700|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328701|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328702|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328703|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328704|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328705|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328706|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328707|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328708|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328709|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328710|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328711|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328712|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328713|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328714|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328715|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328716|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328717|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328718|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328719|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328720|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328721|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328722|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328723|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328724|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328725|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328726|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328727|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328728|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328729|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328730|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328731|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328732|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328733|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328734|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328735|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328736|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328737|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328738|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328739|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328740|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328741|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328742|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328743|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328744|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328745|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328746|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328747|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328748|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328749|NCT00809133|O2|Outcome|Part B: End of 2nd Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
328750|NCT00809133|O1|Outcome|Part B: End of 1st Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
328751|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328752|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328753|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328754|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328777|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328755|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328756|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328757|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328758|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328759|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328760|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328761|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328762|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328763|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328764|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328765|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328766|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328767|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328768|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328769|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328770|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328771|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328772|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328773|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328774|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328775|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328776|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
329160|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
329161|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
328778|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328779|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328780|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328781|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328782|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328783|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328784|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328785|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328786|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328787|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328788|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328789|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328790|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328791|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328792|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328793|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328794|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328795|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328796|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328797|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328798|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328799|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328800|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328823|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328801|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328802|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328803|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328804|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328805|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328806|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328807|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328808|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328809|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328810|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328811|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328812|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328813|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328814|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328815|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328816|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328817|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328818|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328819|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328820|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328821|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328822|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328851|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328824|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328825|NCT00809133|E14|Reported Event|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328826|NCT00809133|E13|Reported Event|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328827|NCT00809133|E12|Reported Event|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328828|NCT00809133|E11|Reported Event|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
328829|NCT00809133|E10|Reported Event|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328830|NCT00809133|E9|Reported Event|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
328831|NCT00809133|E8|Reported Event|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328832|NCT00809133|E7|Reported Event|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328833|NCT00809133|E6|Reported Event|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328834|NCT00809133|E5|Reported Event|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328835|NCT00809133|E4|Reported Event|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
328836|NCT00809133|E3|Reported Event|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328837|NCT00809133|E2|Reported Event|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328838|NCT00809133|E1|Reported Event|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
328839|NCT00809094|B3|Baseline|Total|Total of all reporting groups
328840|NCT00809094|B2|Baseline|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328841|NCT00809094|B1|Baseline|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328842|NCT00809094|P2|Participant Flow|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328843|NCT00809094|P1|Participant Flow|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328844|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328845|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328846|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328847|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328848|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328849|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328850|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
329162|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
329163|NCT00808249|O4|Outcome|D-Placebo|Placebo
328852|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328853|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328854|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328855|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328856|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328857|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328858|NCT00809094|E2|Reported Event|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
328859|NCT00809094|E1|Reported Event|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
328860|NCT00809055|B3|Baseline|Total|Total of all reporting groups
328861|NCT00809055|B2|Baseline|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328862|NCT00809055|B1|Baseline|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328863|NCT00809055|P2|Participant Flow|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328864|NCT00809055|P1|Participant Flow|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328865|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328866|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328867|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328868|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328869|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328870|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328871|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328872|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328873|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328874|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328875|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328876|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328877|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328878|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328879|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328880|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328881|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328882|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328883|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328884|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328885|NCT00809055|E2|Reported Event|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328886|NCT00809055|E1|Reported Event|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
328887|NCT00808899|B1|Baseline|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
328888|NCT00808899|P1|Participant Flow|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
328889|NCT00808899|O1|Outcome|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
328890|NCT00808899|E1|Reported Event|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
328891|NCT00808834|B1|Baseline|Overall|This reporting group includes all enrolled and exposed subjects.
328892|NCT00808834|P2|Participant Flow|Lotrafilcon A / Senofilcon A|Lotrafilcon A, followed by Senofilcon A
328893|NCT00808834|P1|Participant Flow|Senofilcon A / Lotrafilcon A|Senofilcon A, followed by Lotrafilcon A
328894|NCT00808834|O2|Outcome|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
328895|NCT00808834|O1|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
328896|NCT00808834|E2|Reported Event|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
328897|NCT00808834|E1|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
328898|NCT00808808|B4|Baseline|Total|Total of all reporting groups
328899|NCT00808808|B3|Baseline|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328900|NCT00808808|B2|Baseline|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328901|NCT00808808|B1|Baseline|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328902|NCT00808808|P3|Participant Flow|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328903|NCT00808808|P2|Participant Flow|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328904|NCT00808808|P1|Participant Flow|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328905|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
328906|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.
328907|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
328908|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.
328909|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
328910|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white
328911|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328912|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328913|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328914|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328915|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328916|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328917|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328918|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328919|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328920|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328921|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328922|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328923|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328924|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328925|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328926|NCT00808808|E3|Reported Event|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
328927|NCT00808808|E2|Reported Event|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
328928|NCT00808808|E1|Reported Event|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
328929|NCT00808769|B1|Baseline|All Study Participants|
328930|NCT00808769|P2|Participant Flow|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
328931|NCT00808769|P1|Participant Flow|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
328932|NCT00808769|O2|Outcome|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
328933|NCT00808769|O1|Outcome|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
328934|NCT00808769|E2|Reported Event|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
328935|NCT00808769|E1|Reported Event|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
328936|NCT00808639|B1|Baseline|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
328937|NCT00808639|P1|Participant Flow|Dose Dense MVAC|Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
328938|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
328939|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
328940|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
328941|NCT00808639|E1|Reported Event|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
328942|NCT00808509|B3|Baseline|Total|Total of all reporting groups
328943|NCT00808509|B2|Baseline|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329131|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
329164|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
328944|NCT00808509|B1|Baseline|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328945|NCT00808509|P2|Participant Flow|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328946|NCT00808509|P1|Participant Flow|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328947|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328948|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328949|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328950|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328951|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328952|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328953|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328954|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328955|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328956|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328957|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328958|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328959|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328960|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328961|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328962|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329132|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
328963|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328964|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328965|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328966|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328967|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328968|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328969|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328970|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328971|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328972|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328973|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328974|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328975|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328976|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328977|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328978|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328979|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328980|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328981|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329165|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
328982|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328983|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328984|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328985|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328986|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328987|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328988|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328989|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328990|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328991|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328992|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328993|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328994|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328995|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328996|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328997|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328998|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
328999|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329000|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329133|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
329001|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329002|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329003|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329004|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329005|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329006|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329007|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329008|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329009|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329010|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329011|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329012|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329013|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329014|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329015|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329016|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329017|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329018|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329019|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329166|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
329020|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329021|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329022|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329023|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329024|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329025|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329026|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329027|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329028|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329029|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329030|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329031|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329032|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329033|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329034|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329035|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329036|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329037|NCT00808509|E4|Reported Event|Methotrexate-Including Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329038|NCT00808509|E3|Reported Event|Methotrexate-Rescue Arm|Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329167|NCT00808249|E4|Reported Event|D-Placebo|Placebo
329168|NCT00808249|E3|Reported Event|C-AZD7325 10 mg|AZD7325 10 mg QD
329039|NCT00808509|E2|Reported Event|Methotrexate-Excluding Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329040|NCT00808509|E1|Reported Event|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
329041|NCT00808483|B3|Baseline|Total|Total of all reporting groups
329042|NCT00808483|B2|Baseline|Control Group|No participation in the walking skill training group
329043|NCT00808483|B1|Baseline|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist."
329044|NCT00808483|P2|Participant Flow|Control Group|No participation in the walking skill training group
329045|NCT00808483|P1|Participant Flow|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
329046|NCT00808483|O2|Outcome|Control Group|No session of participation in the walking skill training program
329047|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
329048|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
329049|NCT00808483|O1|Outcome|Walking Skilll Training Group|12 sessions of participation in the supervised walking skilll training program
329050|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
329051|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
329052|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
329053|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
329054|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
329055|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training group
329056|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
329057|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in a supervised walking skill training program
329058|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
329059|NCT00808483|O1|Outcome|Walking Skill Training Group|12 session of participation in the supervised walking skill training program
329060|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
329061|NCT00808483|O1|Outcome|Walking Skill Training Group|"12 sessions of participation in the supervised walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
329062|NCT00808483|E2|Reported Event|Control Group|No participation in the walking skill training group
329063|NCT00808483|E1|Reported Event|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
329064|NCT00808444|B3|Baseline|Total|Total of all reporting groups
329065|NCT00808444|B2|Baseline|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329066|NCT00808444|B1|Baseline|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329067|NCT00808444|P2|Participant Flow|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329068|NCT00808444|P1|Participant Flow|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329069|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329134|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
329135|NCT00808340|E3|Reported Event|Balafilcon A|
329136|NCT00808340|E2|Reported Event|Senofilcon A Prod|
329070|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329071|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329072|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329073|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329074|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329075|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329076|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329077|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329078|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329079|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329080|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329081|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329082|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329083|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329137|NCT00808340|E1|Reported Event|Senofilcon A Test|
329138|NCT00808249|B5|Baseline|Total|Total of all reporting groups
329139|NCT00808249|B4|Baseline|D-Placebo|Placebo
329084|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329085|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329086|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329087|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329088|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329089|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329090|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329091|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329092|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329093|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329094|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329095|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329096|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329097|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329140|NCT00808249|B3|Baseline|C-AZD7325 10 mg|AZD7325 10 mg QD
329141|NCT00808249|B2|Baseline|B-AZD7325 5 mg|AZD7325 5 mg BID
329142|NCT00808249|B1|Baseline|A-AZD7325 2 mg|AZD7325 2 mg BID
329098|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329099|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329100|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329101|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329102|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329103|NCT00808444|E2|Reported Event|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329104|NCT00808444|E1|Reported Event|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
329105|NCT00808405|B3|Baseline|Total|Total of all reporting groups
329106|NCT00808405|B2|Baseline|Placebo|Matching placebo tablet
329107|NCT00808405|B1|Baseline|Acyclovir|Acyclovir 400 mg orally three times daily
329108|NCT00808405|P2|Participant Flow|Placebo|Matching placebo tablet
329109|NCT00808405|P1|Participant Flow|Acyclovir|Acyclovir 400 mg orally three times daily
329110|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
329111|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
329112|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
329113|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
329114|NCT00808405|E2|Reported Event|Placebo|Matching placebo tablet
329115|NCT00808405|E1|Reported Event|Acyclovir|Acyclovir 400 mg orally three times daily
329116|NCT00808340|B1|Baseline|Overall|
329117|NCT00808340|P6|Participant Flow|Balafilcon A/Senofilcon A Prod/Senofilcon A Test|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
329118|NCT00808340|P5|Participant Flow|Balafilcon A/Senofilcon A Test/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
329119|NCT00808340|P4|Participant Flow|Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
329120|NCT00808340|P3|Participant Flow|Senofilcon A Prod/Senofilcon A Test/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
329121|NCT00808340|P2|Participant Flow|Senofilcon A Test/Balafilcon A/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
329122|NCT00808340|P1|Participant Flow|Senofilcon A Test/Senofilcon A Prod/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
329123|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
329124|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
329125|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
329126|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
329127|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
329128|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
329129|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
329130|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
329169|NCT00808249|E2|Reported Event|B-AZD7325 5 mg|AZD7325 5 mg BID
329170|NCT00808249|E1|Reported Event|A-AZD7325 2 mg|AZD7325 2 mg BID
329171|NCT00808236|B3|Baseline|Total|Total of all reporting groups
329172|NCT00808236|B2|Baseline|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329173|NCT00808236|B1|Baseline|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329174|NCT00808236|P2|Participant Flow|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329175|NCT00808236|P1|Participant Flow|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329176|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329177|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329178|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329179|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329180|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329181|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329182|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329183|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329184|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329185|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329186|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329187|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329188|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329189|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329190|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329191|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329192|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329193|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329194|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329195|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329196|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329197|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329198|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329199|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329200|NCT00808236|E2|Reported Event|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
329201|NCT00808236|E1|Reported Event|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
329202|NCT00808132|B6|Baseline|Total|Total of all reporting groups
329203|NCT00808132|B5|Baseline|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329204|NCT00808132|B4|Baseline|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329205|NCT00808132|B3|Baseline|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329206|NCT00808132|B2|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329207|NCT00808132|B1|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329208|NCT00808132|P5|Participant Flow|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329209|NCT00808132|P4|Participant Flow|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329210|NCT00808132|P3|Participant Flow|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329211|NCT00808132|P2|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329212|NCT00808132|P1|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329213|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329214|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329215|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329216|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329217|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329218|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329219|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329220|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329221|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329222|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329223|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329224|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329225|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329226|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329227|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329228|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329229|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329230|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329231|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329232|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329233|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329234|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329235|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329236|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329237|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329238|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329239|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329240|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329436|NCT00807885|P6|Participant Flow|Tape-secured 20 ga Teflon Catheter|
329241|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329242|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329243|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329244|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329245|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329246|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329247|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329248|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329249|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329250|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329251|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329252|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329253|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329254|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329255|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329256|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329257|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329258|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329259|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329260|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329261|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329262|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329263|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329264|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329265|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329266|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329267|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329268|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329269|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329270|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
330876|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
329271|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329272|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329273|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329274|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329275|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329276|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329277|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329278|NCT00808132|E5|Reported Event|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329279|NCT00808132|E4|Reported Event|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329280|NCT00808132|E3|Reported Event|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329281|NCT00808132|E2|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329282|NCT00808132|E1|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
329283|NCT00808080|B1|Baseline|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)"
329284|NCT00808080|P1|Participant Flow|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
329285|NCT00808080|O1|Outcome|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
329286|NCT00808080|E1|Reported Event|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
329287|NCT00808067|B3|Baseline|Total|Total of all reporting groups
329288|NCT00808067|B2|Baseline|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329289|NCT00808067|B1|Baseline|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329290|NCT00808067|P2|Participant Flow|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329291|NCT00808067|P1|Participant Flow|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329292|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329293|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329294|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329295|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329296|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329297|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329298|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329299|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329300|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329301|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329302|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329303|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329304|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329305|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329306|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329307|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329308|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329309|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329310|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329311|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329312|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329313|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329314|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329315|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329316|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329317|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329318|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329319|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329320|NCT00808067|E2|Reported Event|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
329321|NCT00808067|E1|Reported Event|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
329322|NCT00808028|B5|Baseline|Total|Total of all reporting groups
329323|NCT00808028|B4|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329324|NCT00808028|B3|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329325|NCT00808028|B2|Baseline|rLP2086 60 mcg|Given on a 0, 2-, 6-month schedule in Stage 1.
329326|NCT00808028|B1|Baseline|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329327|NCT00808028|P4|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329328|NCT00808028|P3|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329329|NCT00808028|P2|Participant Flow|rLP2086 60 Microgram (mcg)|Given on a 0, 2-, 6-month schedule in Stage 1
329330|NCT00808028|P1|Participant Flow|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329331|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329332|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329333|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329334|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329335|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329336|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329337|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329338|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329339|NCT00808028|O3|Outcome|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
329340|NCT00808028|O2|Outcome|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
329341|NCT00808028|O1|Outcome|Control- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
329342|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329343|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329344|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329345|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329346|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329347|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329348|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329349|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329350|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329351|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329352|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329353|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
329354|NCT00808028|E11|Reported Event|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
329355|NCT00808028|E10|Reported Event|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
329356|NCT00808028|E9|Reported Event|Control-Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
329357|NCT00808028|E8|Reported Event|rLP2086 200 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
329358|NCT00808028|E7|Reported Event|rLP2086 120 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
329359|NCT00808028|E6|Reported Event|rLP2086 60 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
329360|NCT00808028|E5|Reported Event|Control-Stage 1 Follow-up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
329361|NCT00808028|E4|Reported Event|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329362|NCT00808028|E3|Reported Event|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329363|NCT00808028|E2|Reported Event|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329364|NCT00808028|E1|Reported Event|Control- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
329365|NCT00808015|B1|Baseline|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329366|NCT00808015|P1|Participant Flow|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329367|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329368|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329437|NCT00807885|P5|Participant Flow|Tegaderm-secured 20 ga Teflon Catheter|
329369|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329370|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329371|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329372|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329373|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329374|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329375|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329376|NCT00808015|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
329377|NCT00807989|B3|Baseline|Total|Total of all reporting groups
329378|NCT00807989|B2|Baseline|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
329379|NCT00807989|B1|Baseline|Carbamazepine|"Carbamazepine~Carbamazepine"
329380|NCT00807989|P2|Participant Flow|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day"
329381|NCT00807989|P1|Participant Flow|Carbamazepine|Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
329382|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
329383|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
329384|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
329385|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
329386|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
329387|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
329388|NCT00807989|E2|Reported Event|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
329389|NCT00807989|E1|Reported Event|Carbamazepine|"Carbamazepine~Carbamazepine"
329390|NCT00807937|B5|Baseline|Total|Total of all reporting groups
329391|NCT00807937|B4|Baseline|Placebo|Placebo
329392|NCT00807937|B3|Baseline|Lorazepam|Lorazepam 2 mg twice daily (BID)
329393|NCT00807937|B2|Baseline|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329394|NCT00807937|B1|Baseline|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329395|NCT00807937|P4|Participant Flow|Placebo|Placebo
329396|NCT00807937|P3|Participant Flow|Lorazepam|Lorazepam 2 mg twice daily (BID)
329397|NCT00807937|P2|Participant Flow|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329398|NCT00807937|P1|Participant Flow|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329399|NCT00807937|O4|Outcome|Placebo|Placebo
329400|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
329401|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329402|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329403|NCT00807937|O4|Outcome|Placebo|Placebo
329404|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
329405|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329406|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329407|NCT00807937|O4|Outcome|Placebo|Placebo
329408|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
329409|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329410|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329411|NCT00807937|O4|Outcome|Placebo|Placebo
329412|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
329413|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329414|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329415|NCT00807937|O4|Outcome|Placebo|Placebo
329416|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
329417|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329418|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329419|NCT00807937|E4|Reported Event|Placebo|Placebo
329420|NCT00807937|E3|Reported Event|Lorazepam|Lorazepam 2 mg twice daily (BID)
329421|NCT00807937|E2|Reported Event|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
329422|NCT00807937|E1|Reported Event|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
329423|NCT00807885|B10|Baseline|Total|Total of all reporting groups
329424|NCT00807885|B9|Baseline|SC Button With 27 ga X 9 mm Needle|
329425|NCT00807885|B8|Baseline|Tape-secured 20 ga Polyurethane Catheter|
329426|NCT00807885|B7|Baseline|Tegaderm-secured 20 ga Polyurethane Catheter|
329427|NCT00807885|B6|Baseline|Tape-secured 20 ga Teflon Catheter|
329428|NCT00807885|B5|Baseline|Tegaderm-secured 20 ga Teflon Catheter|
329429|NCT00807885|B4|Baseline|Tape-secured 24 ga Polyurethane Catheter|
329430|NCT00807885|B3|Baseline|Tegaderm-secured 24 ga Polyurethane Catheter|
329431|NCT00807885|B2|Baseline|Tape-secured 24 ga Teflon Catheter|
329432|NCT00807885|B1|Baseline|Tegaderm-secured 24 ga Teflon Catheter|
329433|NCT00807885|P9|Participant Flow|SC Button With 27 ga X 9 mm Needle|
329434|NCT00807885|P8|Participant Flow|Tape-secured 20 ga Polyurethane Catheter|
329435|NCT00807885|P7|Participant Flow|Tegaderm-secured 20 ga Polyurethane Catheter|
329438|NCT00807885|P4|Participant Flow|Tape-secured 24 ga Polyurethane Catheter|
329439|NCT00807885|P3|Participant Flow|Tegaderm-secured 24 ga Polyurethane Catheter|
329440|NCT00807885|P2|Participant Flow|Tape-secured 24 ga Teflon Catheter|
329441|NCT00807885|P1|Participant Flow|Tegaderm-secured 24 ga Teflon Catheter|
329442|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
329443|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
329444|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
329445|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
329446|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
329447|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
329448|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
329449|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
329450|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
329451|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
329452|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
329453|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
329454|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
329455|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
329456|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
329457|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
329458|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
329459|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
329460|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
329461|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
329462|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
329463|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
329464|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
329465|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
329466|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
329467|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
329468|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
329469|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
329470|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
329471|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
329472|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
329473|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
329474|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
329475|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
329476|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
329477|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
329478|NCT00807885|E9|Reported Event|SC Button With 27 ga X 9 mm Needle|
329479|NCT00807885|E8|Reported Event|Tape-secured 20 ga Polyurethane Catheter|
329480|NCT00807885|E7|Reported Event|Tegaderm-secured 20 ga Polyurethane Catheter|
329481|NCT00807885|E6|Reported Event|Tape-secured 20 ga Teflon Catheter|
329482|NCT00807885|E5|Reported Event|Tegaderm-secured 20 ga Teflon Catheter|
329483|NCT00807885|E4|Reported Event|Tape-secured 24 ga Polyurethane Catheter|
329484|NCT00807885|E3|Reported Event|Tegaderm-secured 24 ga Polyurethane Catheter|
329485|NCT00807885|E2|Reported Event|Tape-secured 24 ga Teflon Catheter|
329486|NCT00807885|E1|Reported Event|Tegaderm-secured 24 ga Teflon Catheter|
329487|NCT00807846|B3|Baseline|Total|Total of all reporting groups
329488|NCT00807846|B2|Baseline|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329489|NCT00807846|B1|Baseline|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329490|NCT00807846|P2|Participant Flow|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329491|NCT00807846|P1|Participant Flow|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329492|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329493|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329494|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329495|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329496|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329497|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329498|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329581|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329499|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329500|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329501|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329502|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329503|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329504|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329505|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329506|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329507|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329508|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329509|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329510|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329511|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329512|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329513|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329514|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329515|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329516|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329517|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329518|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329519|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329520|NCT00807846|E2|Reported Event|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329521|NCT00807846|E1|Reported Event|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
329522|NCT00807573|B1|Baseline|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
329523|NCT00807573|P1|Participant Flow|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
329524|NCT00807573|O1|Outcome|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
329582|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329583|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329584|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329525|NCT00807573|E1|Reported Event|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
329526|NCT00807560|B3|Baseline|Total|Total of all reporting groups
329527|NCT00807560|B2|Baseline|NEC-control|Nutritional Educational Control Condition
329528|NCT00807560|B1|Baseline|FBT-PO|Family Based Therapy for Pediatric Overweight
329529|NCT00807560|P2|Participant Flow|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
329530|NCT00807560|P1|Participant Flow|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
329531|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329532|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329533|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329534|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329535|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329536|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329537|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329538|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329539|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329540|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329541|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329542|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329543|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329544|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329545|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329546|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329547|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329548|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329549|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329550|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329551|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329552|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329553|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329554|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329555|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329556|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329557|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329558|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329559|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
329560|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
329561|NCT00807560|E2|Reported Event|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
329562|NCT00807560|E1|Reported Event|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
329563|NCT00807456|B1|Baseline|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
329564|NCT00807456|P1|Participant Flow|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
329565|NCT00807456|O1|Outcome|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
329566|NCT00807456|E1|Reported Event|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
329567|NCT00807248|B5|Baseline|Total|Total of all reporting groups
329568|NCT00807248|B4|Baseline|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329569|NCT00807248|B3|Baseline|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329570|NCT00807248|B2|Baseline|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329571|NCT00807248|B1|Baseline|Placebo (Orally, Once Daily)|
329572|NCT00807248|P4|Participant Flow|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329573|NCT00807248|P3|Participant Flow|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329574|NCT00807248|P2|Participant Flow|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329575|NCT00807248|P1|Participant Flow|Placebo (Orally, Once Daily)|
329576|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329577|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329578|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329579|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329580|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329585|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329586|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329587|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329588|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329589|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329590|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329591|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329592|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329593|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329594|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329595|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329596|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329597|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329598|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329599|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329600|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329601|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329602|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329603|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329604|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329605|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329606|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329607|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329608|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329609|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329610|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329611|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
329612|NCT00807248|E4|Reported Event|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
329613|NCT00807248|E3|Reported Event|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
329614|NCT00807248|E2|Reported Event|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
329615|NCT00807248|E1|Reported Event|Placebo (Orally, Once Daily)|
329616|NCT00807235|B3|Baseline|Total|Total of all reporting groups
329617|NCT00807235|B2|Baseline|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329618|NCT00807235|B1|Baseline|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329619|NCT00807235|P2|Participant Flow|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329620|NCT00807235|P1|Participant Flow|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329621|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329622|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329623|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329624|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329625|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329626|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329627|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329628|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329629|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329630|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329631|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329632|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329633|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329634|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329635|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329636|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329637|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329638|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329639|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
330274|NCT00805493|P3|Participant Flow|Not Randomized|Those who withdrew prior to the decision to randomize
329640|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329641|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329642|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329643|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329644|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329645|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329646|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329647|NCT00807235|E2|Reported Event|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
329648|NCT00807235|E1|Reported Event|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
329649|NCT00807209|B4|Baseline|Total|Total of all reporting groups
329650|NCT00807209|B3|Baseline|Low Dose SKY0402|
329651|NCT00807209|B2|Baseline|Standard of Care|
329652|NCT00807209|B1|Baseline|High Dose SKY0402|
329653|NCT00807209|P3|Participant Flow|Low Dose SKY0402|
329654|NCT00807209|P2|Participant Flow|Standard of Care|
329655|NCT00807209|P1|Participant Flow|High Dose SKY0402|
329656|NCT00807209|O3|Outcome|Low Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
329657|NCT00807209|O2|Outcome|Standard of Care|Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
329658|NCT00807209|O1|Outcome|High Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
329659|NCT00807209|E3|Reported Event|Low Dose SKY0402|
329660|NCT00807209|E2|Reported Event|Standard of Care|
329661|NCT00807209|E1|Reported Event|High Dose SKY0402|
329662|NCT00807092|B3|Baseline|Total|Total of all reporting groups
329663|NCT00807092|B2|Baseline|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329664|NCT00807092|B1|Baseline|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329665|NCT00807092|P2|Participant Flow|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329666|NCT00807092|P1|Participant Flow|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329667|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329668|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329669|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329670|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329715|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329716|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329671|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329672|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329673|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329674|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329675|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329676|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329677|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329678|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329679|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329680|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329681|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329682|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329683|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329684|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329685|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
330877|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
329686|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329687|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329688|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329689|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329690|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329691|NCT00807092|E2|Reported Event|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329692|NCT00807092|E1|Reported Event|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
329693|NCT00807014|B3|Baseline|Total|Total of all reporting groups
329694|NCT00807014|B2|Baseline|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329695|NCT00807014|B1|Baseline|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329696|NCT00807014|P2|Participant Flow|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329697|NCT00807014|P1|Participant Flow|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329698|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329699|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329700|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329701|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329702|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329703|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329704|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329705|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329706|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329707|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329708|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329709|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329710|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329711|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329712|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329713|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329714|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329717|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329718|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329719|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329720|NCT00807014|E2|Reported Event|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
329721|NCT00807014|E1|Reported Event|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
329722|NCT00807001|B6|Baseline|Total|Total of all reporting groups
329723|NCT00807001|B5|Baseline|IDX184 100 mg|
329724|NCT00807001|B4|Baseline|IDX184 75 mg|
329725|NCT00807001|B3|Baseline|IDX184 50 mg|
329726|NCT00807001|B2|Baseline|IDX184 25 mg|
329727|NCT00807001|B1|Baseline|Placebo|
329728|NCT00807001|P5|Participant Flow|IDX184 100 mg|
329729|NCT00807001|P4|Participant Flow|IDX184 75 mg|
329730|NCT00807001|P3|Participant Flow|IDX184 50 mg|
329731|NCT00807001|P2|Participant Flow|IDX184 25 mg|
329732|NCT00807001|P1|Participant Flow|Placebo|
329733|NCT00807001|O5|Outcome|IDX184 100 mg|
329734|NCT00807001|O4|Outcome|IDX184 75 mg|
329735|NCT00807001|O3|Outcome|IDX184 50 mg|
329736|NCT00807001|O2|Outcome|IDX184 25 mg|
329737|NCT00807001|O1|Outcome|Placebo|
329738|NCT00807001|O5|Outcome|IDX184 100 mg|
329739|NCT00807001|O4|Outcome|IDX184 75 mg|
329740|NCT00807001|O3|Outcome|IDX184 50 mg|
329741|NCT00807001|O2|Outcome|IDX184 25 mg|
329742|NCT00807001|O1|Outcome|Placebo|
329743|NCT00807001|E5|Reported Event|IDX184 100 mg|
329744|NCT00807001|E4|Reported Event|IDX184 75 mg|
329745|NCT00807001|E3|Reported Event|IDX184 50 mg|
329746|NCT00807001|E2|Reported Event|IDX184 25 mg|
329747|NCT00807001|E1|Reported Event|Placebo|
329748|NCT00806819|B3|Baseline|Total|Total of all reporting groups
329749|NCT00806819|B2|Baseline|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329750|NCT00806819|B1|Baseline|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329751|NCT00806819|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329752|NCT00806819|P1|Participant Flow|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329753|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329754|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329755|NCT00806819|O2|Outcome|Nintedanib 150 mg Bid Plus Pemetrexed|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
329756|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329757|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329823|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
330878|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
329758|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329759|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329760|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329761|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329762|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329763|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329764|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329765|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329766|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329767|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329768|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329769|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329770|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329771|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329822|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
330275|NCT00805493|P2|Participant Flow|Placebo|Those randomized to receive placebo
330879|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
329772|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329773|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329774|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329775|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329776|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329777|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329778|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329779|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329780|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329781|NCT00806819|E2|Reported Event|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329782|NCT00806819|E1|Reported Event|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
329783|NCT00806624|B4|Baseline|Total|Total of all reporting groups
329784|NCT00806624|B3|Baseline|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
329785|NCT00806624|B2|Baseline|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329786|NCT00806624|B1|Baseline|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329787|NCT00806624|P3|Participant Flow|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
329788|NCT00806624|P2|Participant Flow|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329789|NCT00806624|P1|Participant Flow|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329790|NCT00806624|O3|Outcome|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
329791|NCT00806624|O2|Outcome|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329792|NCT00806624|O1|Outcome|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329793|NCT00806624|E3|Reported Event|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
329794|NCT00806624|E2|Reported Event|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329795|NCT00806624|E1|Reported Event|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
329796|NCT00806598|B1|Baseline|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
329797|NCT00806598|P1|Participant Flow|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
329798|NCT00806598|O1|Outcome|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + Granulocyte Colony stimulating factor (G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
329799|NCT00806598|E1|Reported Event|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
329800|NCT00806585|B6|Baseline|Total|Total of all reporting groups
329801|NCT00806585|B5|Baseline|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329802|NCT00806585|B4|Baseline|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329803|NCT00806585|B3|Baseline|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329804|NCT00806585|B2|Baseline|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329805|NCT00806585|B1|Baseline|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329806|NCT00806585|P5|Participant Flow|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329807|NCT00806585|P4|Participant Flow|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329808|NCT00806585|P3|Participant Flow|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329809|NCT00806585|P2|Participant Flow|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329810|NCT00806585|P1|Participant Flow|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329811|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329812|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329813|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329814|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329815|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329816|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329817|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329818|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329819|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329820|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329821|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329824|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329825|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329826|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329827|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329828|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329829|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329830|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329831|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329832|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329833|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329834|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329835|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329836|NCT00806585|E5|Reported Event|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
329837|NCT00806585|E4|Reported Event|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329838|NCT00806585|E3|Reported Event|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329839|NCT00806585|E2|Reported Event|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
329840|NCT00806585|E1|Reported Event|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
329841|NCT00806546|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
329842|NCT00806546|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
329843|NCT00806546|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
329844|NCT00806546|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
329845|NCT00806494|B1|Baseline|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329846|NCT00806494|P1|Participant Flow|Fesoterodine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329847|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329848|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329849|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329850|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329851|NCT00806494|O1|Outcome|Fesoteridine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
330880|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
329852|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329853|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329854|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329855|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329856|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329857|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329858|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329859|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329860|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329861|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329862|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329863|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329864|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329865|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329866|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329867|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329868|NCT00806494|E1|Reported Event|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
329869|NCT00806416|B3|Baseline|Total|Total of all reporting groups
329870|NCT00806416|B2|Baseline|Part II|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
329871|NCT00806416|B1|Baseline|Part I|70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
329872|NCT00806416|P4|Participant Flow|Vitamin D Then Alendronate/Vitamin D Combination|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
329873|NCT00806416|P3|Participant Flow|Alendronate/Vitamin D Combination Then Vitamin D|70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
329874|NCT00806416|P2|Participant Flow|Alendronate Then Alendronate/Vitamin D Combination|70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
329875|NCT00806416|P1|Participant Flow|Alendronate/Vitamin D Combination Then Alendronate|70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
329876|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
329877|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
329878|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
329879|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
329880|NCT00806416|O2|Outcome|Alendronate|70 mg alendronate tablet
329881|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
329882|NCT00806416|E3|Reported Event|Vitamin D|2800-IU vitamin D3 tablet
329883|NCT00806416|E2|Reported Event|Alendronate|70 mg alendronate tablet
329884|NCT00806416|E1|Reported Event|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
329885|NCT00806403|B3|Baseline|Total|Total of all reporting groups
329886|NCT00806403|B2|Baseline|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329887|NCT00806403|B1|Baseline|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329994|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
330276|NCT00805493|P1|Participant Flow|Riluzole|Those randomized to riluzole
329888|NCT00806403|P2|Participant Flow|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329889|NCT00806403|P1|Participant Flow|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329890|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329891|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329892|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329893|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329894|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329895|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329896|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329897|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329898|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
329899|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
329900|NCT00806390|B3|Baseline|Total|Total of all reporting groups
329901|NCT00806390|B2|Baseline|Control|Not receiving metoprolol
329902|NCT00806390|B1|Baseline|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
329903|NCT00806390|P2|Participant Flow|Control|Not receiving metoprolol
329904|NCT00806390|P1|Participant Flow|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
329905|NCT00806390|O2|Outcome|Control|Not receiving metoprolol
329906|NCT00806390|O1|Outcome|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
329907|NCT00806390|E2|Reported Event|Control|Not receiving metoprolol
329908|NCT00806390|E1|Reported Event|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
329909|NCT00806351|B3|Baseline|Total|Total of all reporting groups
329910|NCT00806351|B2|Baseline|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329911|NCT00806351|B1|Baseline|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329912|NCT00806351|P2|Participant Flow|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
330277|NCT00805493|O3|Outcome|Riluzole|The group randomized to receive riluzole
329913|NCT00806351|P1|Participant Flow|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329914|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329915|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329916|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329917|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329918|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329919|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329920|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329921|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329995|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
329996|NCT00806078|E2|Reported Event|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
329922|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329923|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329924|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329925|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329926|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329927|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329928|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329929|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329930|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329997|NCT00806078|E1|Reported Event|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
329998|NCT00806026|B7|Baseline|Total|Total of all reporting groups
330278|NCT00805493|O2|Outcome|Not Randomized|Participants who withdrew prior to the decision to randomize
330279|NCT00805493|O1|Outcome|Placebo|The group randomized to receive placebo
329931|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329932|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329933|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329934|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329935|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329936|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329937|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329938|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329939|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
330013|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330881|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
329940|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329941|NCT00806351|E2|Reported Event|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329942|NCT00806351|E1|Reported Event|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
329943|NCT00806260|B7|Baseline|Total|Total of all reporting groups
329944|NCT00806260|B6|Baseline|Alcohol Placebo Only|Subject in this study arm only participated in period 1 and were given alcohol placebo.
329945|NCT00806260|B5|Baseline|Alcohol Only|Subjects in this study arm only participated in period 1 and were given alcohol.
329946|NCT00806260|B4|Baseline|Alcohol Placebo, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
329947|NCT00806260|B3|Baseline|Alcohol Placebo, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
329948|NCT00806260|B2|Baseline|Alcohol, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
329949|NCT00806260|B1|Baseline|Alcohol, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
329950|NCT00806260|P6|Participant Flow|Alcohol-placebo Only|Alcohol-placebo was administered during period one after which the subject's participation ended.
329951|NCT00806260|P5|Participant Flow|Alcohol Only|Alcohol was administered during period one after which the subject's participation ended.
329952|NCT00806260|P4|Participant Flow|Alcohol-placebo, VI-0521 Then VI-0521-placebo|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
329953|NCT00806260|P3|Participant Flow|Alcohol-placebo, VI-0521-placebo Then VI-0521|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
329954|NCT00806260|P2|Participant Flow|Alcohol, VI-0521 Then VI-0521 Placebo|Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
329955|NCT00806260|P1|Participant Flow|Alcohol, VI-0521 Placebo Then VI-0521|Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
329956|NCT00806260|O4|Outcome|Period 3 VI-0521|phentermine/topiramate
329957|NCT00806260|O3|Outcome|Period 3 VI-0521-placebo|placebo
329958|NCT00806260|O2|Outcome|Period 2 VI-0521|phentermine/topiramate
329959|NCT00806260|O1|Outcome|Period 2 VI-0521-placebo|Placebo
329960|NCT00806260|O2|Outcome|Period 1 Alcohol|Alcohol
329961|NCT00806260|O1|Outcome|Period 1 Alcohol-placebo|fruit juice
329962|NCT00806260|E4|Reported Event|Period 2 and 3 Qnexa|The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
329963|NCT00806260|E3|Reported Event|Period 2 and 3 Placebo|Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.
329964|NCT00806260|E2|Reported Event|Period 1 Alcohol|
329965|NCT00806260|E1|Reported Event|Period 1 Placebo|
329966|NCT00806195|B5|Baseline|Total|Total of all reporting groups
329967|NCT00806195|B4|Baseline|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
330014|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
329968|NCT00806195|B3|Baseline|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
329969|NCT00806195|B2|Baseline|Routine Vaccines (Non-Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329970|NCT00806195|B1|Baseline|MenACWY-CRM197 + Routine Vaccines (Non-Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329971|NCT00806195|P4|Participant Flow|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs."
329972|NCT00806195|P3|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
329973|NCT00806195|P2|Participant Flow|Routine Vaccines (Non-detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329974|NCT00806195|P1|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Non-detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE)."
329975|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
329976|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
329977|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
329978|NCT00806195|O1|Outcome|MenACWY-CRM 197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
330015|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330882|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
329979|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329980|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329981|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
329982|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
329983|NCT00806195|E2|Reported Event|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329984|NCT00806195|E1|Reported Event|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
329985|NCT00806078|B3|Baseline|Total|Total of all reporting groups
329986|NCT00806078|B2|Baseline|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
329987|NCT00806078|B1|Baseline|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
329988|NCT00806078|P2|Participant Flow|Quinine With Chocolate Pudding First|Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
329989|NCT00806078|P1|Participant Flow|Quinine Alone First|Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
329990|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
329991|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
329992|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
329993|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
330262|NCT00805545|B2|Baseline|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
329999|NCT00806026|B6|Baseline|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330000|NCT00806026|B5|Baseline|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330001|NCT00806026|B4|Baseline|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330002|NCT00806026|B3|Baseline|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330003|NCT00806026|B2|Baseline|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330004|NCT00806026|B1|Baseline|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330005|NCT00806026|P6|Participant Flow|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330006|NCT00806026|P5|Participant Flow|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330007|NCT00806026|P4|Participant Flow|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330008|NCT00806026|P3|Participant Flow|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330009|NCT00806026|P2|Participant Flow|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330010|NCT00806026|P1|Participant Flow|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330011|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330012|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330263|NCT00805545|B1|Baseline|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
330016|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330017|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330018|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330019|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330020|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330021|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330022|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330023|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330024|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330025|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330026|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330027|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330028|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330029|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330030|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330031|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330280|NCT00805493|O3|Outcome|Not Randomized|Those who withdrew prior to the decision to randomize
330032|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330033|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330034|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330035|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330036|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330037|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330038|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330039|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330040|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330041|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330042|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330043|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330044|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330045|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330046|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330047|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330281|NCT00805493|O2|Outcome|Placebo|
330282|NCT00805493|O1|Outcome|Riluzole|The group randomized to riluzole
330048|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330049|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330050|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330051|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330052|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330053|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330054|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330055|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330056|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330057|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330058|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330059|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330060|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330061|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330062|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330063|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330283|NCT00805493|E3|Reported Event|Not Randomized|
330284|NCT00805493|E2|Reported Event|Placebo|
330064|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330065|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330066|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330067|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330068|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330069|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330070|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330071|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330072|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330073|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330074|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330075|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330076|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330077|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330078|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330079|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330285|NCT00805493|E1|Reported Event|Riluzole|
330286|NCT00805480|B5|Baseline|Total|Total of all reporting groups
330080|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330081|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330082|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330083|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330084|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330085|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330086|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330087|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330088|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330089|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330090|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330091|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330092|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330093|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330094|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
330095|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330096|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330097|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330098|NCT00806026|E6|Reported Event|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330099|NCT00806026|E5|Reported Event|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330100|NCT00806026|E4|Reported Event|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330101|NCT00806026|E3|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330102|NCT00806026|E2|Reported Event|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
330103|NCT00806026|E1|Reported Event|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
330104|NCT00805961|B1|Baseline|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330105|NCT00805961|P1|Participant Flow|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330106|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330107|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330108|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330109|NCT00805961|E1|Reported Event|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
330110|NCT00805935|B5|Baseline|Total|Total of all reporting groups
330111|NCT00805935|B4|Baseline|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330112|NCT00805935|B3|Baseline|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330113|NCT00805935|B2|Baseline|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330264|NCT00805545|P2|Participant Flow|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
330114|NCT00805935|B1|Baseline|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330115|NCT00805935|P4|Participant Flow|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330116|NCT00805935|P3|Participant Flow|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330117|NCT00805935|P2|Participant Flow|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330118|NCT00805935|P1|Participant Flow|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330119|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330120|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330121|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330122|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330123|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330124|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330125|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330126|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330127|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330128|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330129|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330130|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330287|NCT00805480|B4|Baseline|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330131|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330132|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330133|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330134|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330135|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330136|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330137|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330138|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330139|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330140|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330141|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330142|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330143|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330144|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330145|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330146|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330147|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330265|NCT00805545|P1|Participant Flow|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
330148|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330149|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330150|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330151|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330152|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330153|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330154|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330155|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330156|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330157|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330158|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330159|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330160|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
330161|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330162|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330163|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330288|NCT00805480|B3|Baseline|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330164|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330165|NCT00805935|E4|Reported Event|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330166|NCT00805935|E3|Reported Event|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330167|NCT00805935|E2|Reported Event|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330168|NCT00805935|E1|Reported Event|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
330169|NCT00805870|B3|Baseline|Total|Total of all reporting groups
330170|NCT00805870|B2|Baseline|Control|Wheat Germ Oil, 3 grams/day for 65 days
330171|NCT00805870|B1|Baseline|Fish Oil|Lovaza, 3 grams/day for 65 days
330172|NCT00805870|P2|Participant Flow|Control|Wheat Germ Oil, 3 grams/day for 65 days
330173|NCT00805870|P1|Participant Flow|Fish Oil|Lovaza, 3 grams/day for 65 days
330174|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
330175|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
330176|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
330177|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
330178|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
330179|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
330180|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
330181|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
330182|NCT00805870|E2|Reported Event|Control|Wheat Germ Oil, 3 grams/day for 65 days
330183|NCT00805870|E1|Reported Event|Fish Oil|Lovaza, 3 grams/day for 65 days
330184|NCT00805792|B1|Baseline|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330185|NCT00805792|P1|Participant Flow|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330186|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330187|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330188|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330189|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330190|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330191|NCT00805792|E1|Reported Event|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
330192|NCT00805766|B1|Baseline|TA-650|
330193|NCT00805766|P1|Participant Flow|TA-650|"Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.~Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal."
330194|NCT00805766|O1|Outcome|TA-650|
330195|NCT00805766|O1|Outcome|TA-650|
330196|NCT00805766|E3|Reported Event|Increased Dose Period|
330197|NCT00805766|E2|Reported Event|Screening Period|
330198|NCT00805766|E1|Reported Event|Entire Evaluation Period|Screening Period + Increased Dose Period
330199|NCT00805740|B3|Baseline|Total|Total of all reporting groups
330266|NCT00805545|O2|Outcome|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
330267|NCT00805545|O1|Outcome|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
330883|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330200|NCT00805740|B2|Baseline|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330201|NCT00805740|B1|Baseline|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330202|NCT00805740|P2|Participant Flow|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330203|NCT00805740|P1|Participant Flow|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330204|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330205|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330206|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330207|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330208|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330209|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330210|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330211|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330212|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330213|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330268|NCT00805545|E2|Reported Event|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
330269|NCT00805545|E1|Reported Event|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
330214|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330215|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330216|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330217|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330218|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330219|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330220|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330221|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330222|NCT00805740|E2|Reported Event|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330223|NCT00805740|E1|Reported Event|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
330224|NCT00805675|B4|Baseline|Total|Total of all reporting groups
330225|NCT00805675|B3|Baseline|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330226|NCT00805675|B2|Baseline|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330227|NCT00805675|B1|Baseline|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330270|NCT00805493|B4|Baseline|Total|Total of all reporting groups
330271|NCT00805493|B3|Baseline|Not Randomized|
330272|NCT00805493|B2|Baseline|Placebo|
330273|NCT00805493|B1|Baseline|Riluzole|
330228|NCT00805675|P3|Participant Flow|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330229|NCT00805675|P2|Participant Flow|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330230|NCT00805675|P1|Participant Flow|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330231|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330232|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330233|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330234|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330235|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330236|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330237|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330238|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330239|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330240|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330241|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330242|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330243|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330244|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330245|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330246|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330247|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330248|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330249|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330884|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330250|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330251|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330252|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330253|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330254|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330255|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330256|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330257|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330258|NCT00805675|E3|Reported Event|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330259|NCT00805675|E2|Reported Event|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330260|NCT00805675|E1|Reported Event|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
330261|NCT00805545|B3|Baseline|Total|Total of all reporting groups
330289|NCT00805480|B2|Baseline|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330290|NCT00805480|B1|Baseline|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330291|NCT00805480|P4|Participant Flow|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330292|NCT00805480|P3|Participant Flow|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330293|NCT00805480|P2|Participant Flow|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330294|NCT00805480|P1|Participant Flow|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330295|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330296|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330297|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330298|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330299|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330300|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330301|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330302|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330303|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330304|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330305|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330306|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330307|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330308|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330309|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330310|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330311|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330312|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330313|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330314|NCT00805480|E4|Reported Event|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
330315|NCT00805480|E3|Reported Event|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
330316|NCT00805480|E2|Reported Event|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
330317|NCT00805480|E1|Reported Event|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
330318|NCT00805467|B5|Baseline|Total|Total of all reporting groups
330319|NCT00805467|B4|Baseline|Fostamatinib 100 mg Bid|Oral treatment
330320|NCT00805467|B3|Baseline|Fostamatinib 150 mg qd|Oral treatment
330321|NCT00805467|B2|Baseline|Fostamatinib 100 mg qd|Oral treatment
330322|NCT00805467|B1|Baseline|Fostamatinib 50 mg Bid|Oral treatment
330323|NCT00805467|P4|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
330324|NCT00805467|P3|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
330325|NCT00805467|P2|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
330326|NCT00805467|P1|Participant Flow|Fostamatinib 50 mg Bid|Oral treatment
330327|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
330328|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
330329|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
330330|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
330331|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
330332|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
330333|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
330334|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
330335|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
330336|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
330337|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
330338|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
330339|NCT00805467|E4|Reported Event|50 MG BID|
330340|NCT00805467|E3|Reported Event|150 MG QD|
330341|NCT00805467|E2|Reported Event|100 MG QD|
330342|NCT00805467|E1|Reported Event|100 MG BID|
330343|NCT00804193|B4|Baseline|Total|Total of all reporting groups
330344|NCT00804193|B3|Baseline|Vehicle Product|placebo of test product
330345|NCT00804193|B2|Baseline|Reference Product|Loprox® Topical Suspension 0.77%
330346|NCT00804193|B1|Baseline|Test Product|Ciclopirox Olamine Topical Suspension
330347|NCT00804193|P3|Participant Flow|Vehicle Product|placebo of test product was applied treatment two times a day for 4 weeks
330348|NCT00804193|P2|Participant Flow|Reference Product|Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
330349|NCT00804193|P1|Participant Flow|Test Product|Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
330350|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
330351|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
330352|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
330353|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
330354|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
330355|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
330356|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
330357|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
330358|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
330359|NCT00804193|E3|Reported Event|Vehicle Product|placebo of test product
330360|NCT00804193|E2|Reported Event|Reference Product|Loprox® Topical Suspension 0.77%
330361|NCT00804193|E1|Reported Event|Test Product|Ciclopirox Olamine Topical Suspension
330362|NCT00805389|B6|Baseline|Total|Total of all reporting groups
330363|NCT00805389|B5|Baseline|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330364|NCT00805389|B4|Baseline|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330365|NCT00805389|B3|Baseline|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330366|NCT00805389|B2|Baseline|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330367|NCT00805389|B1|Baseline|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330368|NCT00805389|P5|Participant Flow|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330369|NCT00805389|P4|Participant Flow|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330370|NCT00805389|P3|Participant Flow|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330371|NCT00805389|P2|Participant Flow|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330645|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330646|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330372|NCT00805389|P1|Participant Flow|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330373|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330374|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330375|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330376|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330377|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330378|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330379|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330380|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330381|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330382|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330383|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330647|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330885|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330384|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330385|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330386|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330387|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330388|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330389|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330390|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330391|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330392|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330393|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330394|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330395|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330648|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330886|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330396|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330397|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330398|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330399|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330400|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330401|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330402|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330403|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330404|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330405|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330406|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330407|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330649|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330889|NCT00804648|E1|Reported Event|Timolol Hemihydrate 0.5%|
330408|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330409|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330410|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330411|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330412|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330413|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330414|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330415|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330416|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330417|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330418|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330419|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330650|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330651|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330420|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330421|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330422|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330423|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330424|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330425|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330426|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330427|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330428|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330429|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330430|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330431|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330432|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330887|NCT00804648|E3|Reported Event|Timolol Maleate Gel Forming Solution 0.5%|
330433|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330434|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330435|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330436|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330437|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330438|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330439|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330440|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330441|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330442|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330443|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330444|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330445|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330446|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330447|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330448|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330449|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330450|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330451|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330452|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330453|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330454|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330455|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330456|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330457|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330458|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330459|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330460|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330461|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330462|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330463|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330464|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330465|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330466|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330467|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330468|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330469|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330470|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330471|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330472|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330473|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330474|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330475|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330476|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330477|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330478|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330479|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330480|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330481|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330482|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330483|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330484|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330652|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330653|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330485|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330486|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330487|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330488|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330489|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330490|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330491|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330492|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330493|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330494|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330495|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330496|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330654|NCT00805194|E2|Reported Event|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330888|NCT00804648|E2|Reported Event|Timolol Maleate 0.5%|
330497|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330498|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330499|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330500|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330501|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330502|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330503|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330504|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330505|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330506|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330507|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330508|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330509|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330510|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330722|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330511|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330512|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330513|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330514|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330515|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
330516|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330517|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330518|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330519|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330520|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330521|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330522|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330523|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330524|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330859|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330860|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330525|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330526|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330527|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330528|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330529|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330530|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330531|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330532|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330533|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330534|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330535|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330536|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330537|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330655|NCT00805194|E1|Reported Event|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330656|NCT00805142|B3|Baseline|Total|Total of all reporting groups
330538|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330539|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330540|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330541|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330542|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330543|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330544|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330545|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330546|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330547|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330548|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330549|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330550|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330709|NCT00804986|P2|Participant Flow|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330861|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330862|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330551|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330552|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330553|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330554|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330555|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330556|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330557|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330558|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330559|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330560|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330561|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330562|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330563|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330863|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330564|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330565|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330566|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330567|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330568|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330569|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330570|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330571|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330572|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330573|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330574|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330575|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330710|NCT00804986|P1|Participant Flow|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330864|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330576|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330577|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330578|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330579|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330580|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330581|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330582|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330583|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330584|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330585|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330586|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330587|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330711|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330865|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330588|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330589|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330590|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330591|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330592|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330593|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330594|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330595|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330596|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330597|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330598|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330599|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330712|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330866|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330600|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330601|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330602|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330603|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330604|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330605|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330606|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330607|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330608|NCT00805389|E5|Reported Event|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330609|NCT00805389|E4|Reported Event|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330610|NCT00805389|E3|Reported Event|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330611|NCT00805389|E2|Reported Event|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330713|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330867|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330612|NCT00805389|E1|Reported Event|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
330613|NCT00805285|B1|Baseline|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330614|NCT00805285|P1|Participant Flow|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
330615|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330616|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330617|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330618|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330619|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330620|NCT00805285|E1|Reported Event|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
330621|NCT00805194|B3|Baseline|Total|Total of all reporting groups
330622|NCT00805194|B2|Baseline|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330623|NCT00805194|B1|Baseline|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330624|NCT00805194|P2|Participant Flow|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330625|NCT00805194|P1|Participant Flow|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330626|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330627|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330628|NCT00805194|O2|Outcome|Nintedanib 150 Bid mg Plus Docetaxel|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330629|NCT00805194|O1|Outcome|Nitedanib 200 mg Bid Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330630|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330631|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330632|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330633|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330634|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330635|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330636|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330637|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330638|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).
330639|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330640|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330641|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330642|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330643|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330644|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
330868|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330657|NCT00805142|B2|Baseline|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330658|NCT00805142|B1|Baseline|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330659|NCT00805142|P2|Participant Flow|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330660|NCT00805142|P1|Participant Flow|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330661|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330662|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330663|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330664|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330714|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330715|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330716|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330665|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330666|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330667|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330668|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330669|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330670|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330671|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330717|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330718|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330719|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330672|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330673|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330674|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330675|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330676|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330677|NCT00805142|O2|Outcome|Opioid-Switch Participants Titration Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day.
330678|NCT00805142|O1|Outcome|Opioid-Naive Participants Titration Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 mg oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day.
330679|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330680|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330720|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330721|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330681|NCT00805142|E2|Reported Event|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
330682|NCT00805142|E1|Reported Event|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
330683|NCT00805038|B3|Baseline|Total|Total of all reporting groups
330684|NCT00805038|B2|Baseline|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
330685|NCT00805038|B1|Baseline|Usual Care|Usual care received by participants
330686|NCT00805038|P2|Participant Flow|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
330687|NCT00805038|P1|Participant Flow|Usual Care|Usual care received by participants
330688|NCT00805038|O2|Outcome|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
330689|NCT00805038|O1|Outcome|Usual Care|Usual care received by participants
330690|NCT00805038|E2|Reported Event|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
330691|NCT00805038|E1|Reported Event|Usual Care|Usual care received by participants
330692|NCT00805025|B1|Baseline|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330693|NCT00805025|P1|Participant Flow|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330694|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330695|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330696|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330697|NCT00805025|E1|Reported Event|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
330698|NCT00804986|B7|Baseline|Total|Total of all reporting groups
330699|NCT00804986|B6|Baseline|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330700|NCT00804986|B5|Baseline|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330701|NCT00804986|B4|Baseline|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330702|NCT00804986|B3|Baseline|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330703|NCT00804986|B2|Baseline|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330704|NCT00804986|B1|Baseline|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330705|NCT00804986|P6|Participant Flow|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330706|NCT00804986|P5|Participant Flow|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330707|NCT00804986|P4|Participant Flow|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330708|NCT00804986|P3|Participant Flow|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330869|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330723|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330724|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330725|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330726|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330727|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330728|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330729|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330730|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330731|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330732|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330733|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330734|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330735|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330736|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330737|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330738|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330739|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330740|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330741|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330742|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330743|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330744|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330745|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330746|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330747|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330748|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330749|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330750|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330751|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330752|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330753|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330754|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330755|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330870|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330756|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330757|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330758|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330759|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330760|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330761|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330762|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330763|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330764|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330765|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330766|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330767|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330768|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330769|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330770|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330771|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330772|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330773|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330774|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330775|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330776|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330777|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330778|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330779|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330780|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330781|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330782|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330783|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330784|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330785|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330786|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330787|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330788|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330871|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330789|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330790|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330791|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330792|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330793|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330794|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330795|NCT00804986|E6|Reported Event|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330796|NCT00804986|E5|Reported Event|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330797|NCT00804986|E4|Reported Event|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330798|NCT00804986|E3|Reported Event|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330799|NCT00804986|E2|Reported Event|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330800|NCT00804986|E1|Reported Event|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
330801|NCT00804843|B3|Baseline|Total|Total of all reporting groups
330802|NCT00804843|B2|Baseline|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
330803|NCT00804843|B1|Baseline|Statin 80 mg + Niacin ER|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
330804|NCT00804843|P2|Participant Flow|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
330805|NCT00804843|P1|Participant Flow|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
330806|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
330807|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
330808|NCT00804843|O2|Outcome|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~receive 10 mg Atorvastatin."
330809|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
330810|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
330811|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
330812|NCT00804843|E2|Reported Event|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~recieve 10 mg Atorvastatin."
330813|NCT00804843|E1|Reported Event|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will recieve 80 mg Atorvastatin + niacin
330814|NCT00804713|B1|Baseline|All Study Participants|Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
330815|NCT00804713|P1|Participant Flow|All Study Participants|Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
330816|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
330817|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
330818|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
330819|NCT00804713|O1|Outcome|QFT-GIT|"Subjects administered the QFT-GIT TB test~QFT-GIT: Perform QFT-GIT TB test"
330820|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
330821|NCT00804713|E1|Reported Event|All Study Participants|Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
330822|NCT00804687|B1|Baseline|Entire Study Population|Includes all participants randomized in the study.
330872|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330873|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330874|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330875|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330823|NCT00804687|P6|Participant Flow|Pseudoephedrine Then Placebo Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330824|NCT00804687|P5|Participant Flow|Pseudoephedrine Then JNJ-39220675 Then Placebo|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330825|NCT00804687|P4|Participant Flow|Placebo Then Pseudoephedrine Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330826|NCT00804687|P3|Participant Flow|Placebo Then JNJ-39220675 Then Pseudoephedrine|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330827|NCT00804687|P2|Participant Flow|JNJ-39220675 Then Placebo Then Pseudoephedrine|Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330828|NCT00804687|P1|Participant Flow|JNJ-39220675 Then Pseudoephedrine Then Placebo|Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
330829|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
330830|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
330831|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
330832|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
330833|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
330834|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
330835|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
330836|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
330837|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
330838|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
330839|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
330840|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
330841|NCT00804687|E3|Reported Event|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
330842|NCT00804687|E2|Reported Event|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
330843|NCT00804687|E1|Reported Event|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
330844|NCT00804648|B1|Baseline|Overall|
330845|NCT00804648|P6|Participant Flow|Maleate Gel/Maleate/Hemihydrate|Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
330846|NCT00804648|P5|Participant Flow|Maleate/Hemihydrate/Maleate Gel|Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
330847|NCT00804648|P4|Participant Flow|Hemihydrate/Maleate Gel/Maleate|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
330848|NCT00804648|P3|Participant Flow|Maleate Gel/Hemihydrate/Maleate|Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
330849|NCT00804648|P2|Participant Flow|Maleate/Maleate Gel/Hemihydrate|Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
330850|NCT00804648|P1|Participant Flow|Hemihydrate/Maleate/Maleate Gel|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
330851|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330852|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330853|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330854|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330855|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330856|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
330857|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
330858|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
330890|NCT00804609|B3|Baseline|Total|Total of all reporting groups
330891|NCT00804609|B2|Baseline|Epidural DepoDur Following Spinal Anesthetic|"Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.~DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.~Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
330892|NCT00804609|B1|Baseline|Epidural DepoDur Following Epidural Lidocaine Administration|"Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.~DepoDur: All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.~Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
330893|NCT00804609|P2|Participant Flow|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
330894|NCT00804609|P1|Participant Flow|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
330895|NCT00804609|O2|Outcome|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
330896|NCT00804609|O1|Outcome|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
330897|NCT00804609|E2|Reported Event|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
330898|NCT00804609|E1|Reported Event|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
330899|NCT00804596|B1|Baseline|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
330900|NCT00804596|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
330901|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
330902|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
330903|NCT00804596|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
330904|NCT00804570|B3|Baseline|Total|Total of all reporting groups
330905|NCT00804570|B2|Baseline|Placebo|once daily, orally, 16 weeks
330906|NCT00804570|B1|Baseline|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330907|NCT00804570|P2|Participant Flow|Placebo|once daily, orally, 16 weeks
330908|NCT00804570|P1|Participant Flow|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330909|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330910|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330911|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330912|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330913|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330914|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330915|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330916|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330917|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330918|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330919|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330920|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330921|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330922|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330923|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330924|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330925|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330926|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330927|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
330928|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
330929|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330930|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330931|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330932|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330933|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330934|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330935|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330936|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330937|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330938|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330939|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330940|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330941|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330942|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330943|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330944|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330945|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330946|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330947|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330948|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330949|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330950|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330951|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330952|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330953|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330954|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330955|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330956|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330957|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330958|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330959|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
330960|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
330961|NCT00804570|E2|Reported Event|Placebo|once daily (QD), orally (PO), 16 weeks
330962|NCT00804570|E1|Reported Event|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
330963|NCT00803959|B3|Baseline|Total|Total of all reporting groups
330964|NCT00803959|B2|Baseline|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330965|NCT00803959|B1|Baseline|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330966|NCT00803959|P2|Participant Flow|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330967|NCT00803959|P1|Participant Flow|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330968|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330969|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330970|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330971|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330972|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330973|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330974|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330975|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330976|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
331005|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D administered as 2 x 2800 IU tablets
330977|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330978|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330979|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330980|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330981|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330982|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330983|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330984|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330985|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330986|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330987|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330988|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330989|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330990|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330991|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330992|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330993|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330994|NCT00803959|E2|Reported Event|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330995|NCT00803959|E1|Reported Event|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
330996|NCT00803790|B3|Baseline|Total|Total of all reporting groups
330997|NCT00803790|B2|Baseline|Part 2|"Alendronate+vitamin D combo, then vitamin D: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets. A washout of at least 12 days separated each treatment period.~Vitamin D, then alendronate+vitamin D combo: In Period 1 participants received a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
330998|NCT00803790|B1|Baseline|Part 1|"Alendronate+vitamin D combo, then alendronate: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 70mg alendronate tablet. A washout of at least 12 days separated each treatment period.~Alendronate, then alendronate+vitamin D combo: In Period 1 participants received 70mg alendronate tablet, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
330999|NCT00803790|P4|Participant Flow|Part 2 Vitamin D, Then Alendronate+Vitamin D Combo|Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
331000|NCT00803790|P3|Participant Flow|Part 2 Alendronate+Vitamin D Combo, Then Vitamin D|Participants in Part 2 received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
331001|NCT00803790|P2|Participant Flow|Part 1 Alendronate, Then Alendronate+Vitamin D Combo|Participants in Part 1 received a single dose of 70mg alendronate tablet in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
331002|NCT00803790|P1|Participant Flow|Part 1 Alendronate+Vitamin D Combo, Then Alendronate|Participants in Part 1 received a single dose of 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by a single dose of 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
331003|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
331004|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
331006|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|A single dose of 70mg alendronate+5600 IU vitamin D combination tablet
331007|NCT00803790|O2|Outcome|Alendronate|Single dose of 70mg alendronate tablet
331008|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70mg alendronate+5600 IU vitamin D combination tablet
331009|NCT00803790|E3|Reported Event|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
331010|NCT00803790|E2|Reported Event|Alendronate|Single dose of 70mg alendronate tablet
331011|NCT00803790|E1|Reported Event|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
331012|NCT00803777|B1|Baseline|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331013|NCT00803777|P1|Participant Flow|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331014|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331015|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331016|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331017|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331018|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331019|NCT00803777|E1|Reported Event|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
331020|NCT00803738|B3|Baseline|Total|Total of all reporting groups
331021|NCT00803738|B2|Baseline|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331022|NCT00803738|B1|Baseline|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331023|NCT00803738|P2|Participant Flow|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331024|NCT00803738|P1|Participant Flow|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331025|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331026|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331027|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331028|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331029|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331030|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331031|NCT00803738|E2|Reported Event|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
331032|NCT00803738|E1|Reported Event|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
331033|NCT00803712|B3|Baseline|Total|Total of all reporting groups
331034|NCT00803712|B2|Baseline|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331035|NCT00803712|B1|Baseline|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331036|NCT00803712|P2|Participant Flow|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331037|NCT00803712|P1|Participant Flow|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331173|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
331038|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331039|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331040|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331041|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331042|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331043|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331044|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331045|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331046|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331047|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331048|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331049|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331050|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331051|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331052|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331053|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331054|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331055|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331056|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331057|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331058|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331059|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331060|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331061|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331062|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331063|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331064|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331065|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331066|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331067|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331068|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331069|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331070|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331071|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331072|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331073|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331074|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331075|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331076|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331077|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331078|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331079|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331080|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331081|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331082|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331083|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331084|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331085|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331086|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331087|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331088|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331089|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331090|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331091|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331092|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331093|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331094|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331095|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331096|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331097|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331098|NCT00803712|E2|Reported Event|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
331099|NCT00803712|E1|Reported Event|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
331100|NCT00803686|B5|Baseline|Total|Total of all reporting groups
331101|NCT00803686|B4|Baseline|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
331102|NCT00803686|B3|Baseline|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
331103|NCT00803686|B2|Baseline|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
331104|NCT00803686|B1|Baseline|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
331105|NCT00803686|P4|Participant Flow|Fortical Nasal Spray (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
331106|NCT00803686|P3|Participant Flow|Oral rsCT Tablets (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal.
331107|NCT00803686|P2|Participant Flow|Oral Placebo|In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal.
331108|NCT00803686|P1|Participant Flow|Oral Recombinant Salmon Calcitonin (rsCT)|In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal.
331109|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
331110|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
331111|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
331112|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
331113|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
331114|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
331115|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
331116|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
331117|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
331118|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|Subjects were given oral rsCT tablets four hours after the evening meal
331119|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
331120|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
331121|NCT00803686|E4|Reported Event|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
331122|NCT00803686|E3|Reported Event|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
331123|NCT00803686|E2|Reported Event|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
331124|NCT00803686|E1|Reported Event|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
331125|NCT00803647|B1|Baseline|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331126|NCT00803647|P1|Participant Flow|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331127|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331128|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331129|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331130|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331131|NCT00803647|E1|Reported Event|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
331132|NCT00803634|B3|Baseline|Total|Total of all reporting groups
331133|NCT00803634|B2|Baseline|SOC IV Antihypertensive Therapy|All randomized and eligible patients who received any SOC dose.
331134|NCT00803634|B1|Baseline|Clevidipine Emulsion|All randomized and eligible patients who received any dose of clevidipine.
331174|NCT00803595|E3|Reported Event|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
331175|NCT00803595|E2|Reported Event|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
331135|NCT00803634|P2|Participant Flow|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331136|NCT00803634|P1|Participant Flow|Clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331137|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331138|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331139|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331140|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331141|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331142|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331143|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331144|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331145|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331146|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331147|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331148|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331176|NCT00803595|E1|Reported Event|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
331149|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331150|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331151|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331152|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331153|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331154|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331155|NCT00803634|O2|Outcome|SOC IV Therapy|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331156|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331157|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331158|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331159|NCT00803634|E2|Reported Event|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
331160|NCT00803634|E1|Reported Event|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
331161|NCT00803595|B4|Baseline|Total|Total of all reporting groups
331162|NCT00803595|B3|Baseline|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
331163|NCT00803595|B2|Baseline|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
331164|NCT00803595|B1|Baseline|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
331165|NCT00803595|P3|Participant Flow|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
331166|NCT00803595|P2|Participant Flow|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
331167|NCT00803595|P1|Participant Flow|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
331168|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
331169|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
331170|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
331171|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
331172|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
331177|NCT00803517|B3|Baseline|Total|Total of all reporting groups
331178|NCT00803517|B2|Baseline|Focal Laser Photocoagulation|
331179|NCT00803517|B1|Baseline|Photodynamic Therapy|
331180|NCT00803517|P2|Participant Flow|Focal Laser Photocoagulation|
331181|NCT00803517|P1|Participant Flow|Photodynamic Therapy|
331182|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
331183|NCT00803517|O1|Outcome|Photodynamic Therapy|
331184|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
331185|NCT00803517|O1|Outcome|Photodynamic Therapy|
331186|NCT00803413|B5|Baseline|Total|Total of all reporting groups
331187|NCT00803413|B4|Baseline|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
331188|NCT00803413|B3|Baseline|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
331189|NCT00803413|B2|Baseline|Supervised Walking|
331190|NCT00803413|B1|Baseline|Back School|
331191|NCT00803413|P4|Participant Flow|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
331192|NCT00803413|P3|Participant Flow|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
331193|NCT00803413|P2|Participant Flow|Supervised Walking|
331194|NCT00803413|P1|Participant Flow|Back School|
331195|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
331196|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
331197|NCT00803413|O2|Outcome|Supervised Walking|
331198|NCT00803413|O1|Outcome|Back School|
331199|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
331200|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
331201|NCT00803413|O2|Outcome|Supervised Walking|
331202|NCT00803413|O1|Outcome|Back School|
331203|NCT00803400|B3|Baseline|Total|Total of all reporting groups
331204|NCT00803400|B2|Baseline|Alprazolam + Aerobic Exercise|
331205|NCT00803400|B1|Baseline|Alprazolam|
331206|NCT00803400|P2|Participant Flow|Alprazolam + Aerobic Exercise|
331207|NCT00803400|P1|Participant Flow|Alprazolam|
331208|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
331209|NCT00803400|O1|Outcome|Alprazolam|
331210|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
331211|NCT00803400|O1|Outcome|Alprazolam|
331212|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
331213|NCT00803400|O1|Outcome|Alprazolam|
331214|NCT00803400|E2|Reported Event|Alprazolam + Aerobic Exercise|
331215|NCT00803400|E1|Reported Event|Alprazolam|
331216|NCT00803361|B3|Baseline|Total|Total of all reporting groups
331217|NCT00803361|B2|Baseline|Placebo|placebo capsules, oral, once a day for 15 weeks
331218|NCT00803361|B1|Baseline|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331219|NCT00803361|P2|Participant Flow|Placebo|placebo capsules, oral, once a day for 15 weeks
331220|NCT00803361|P1|Participant Flow|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331221|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331222|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331223|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331224|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331225|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331226|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331227|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331228|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331229|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331230|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331231|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331232|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331233|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
331234|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331235|NCT00803361|E2|Reported Event|Placebo|placebo capsules, oral, once a day for 15 weeks
331236|NCT00803361|E1|Reported Event|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
331237|NCT00803283|B3|Baseline|Total|Total of all reporting groups
331238|NCT00803283|B2|Baseline|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331239|NCT00803283|B1|Baseline|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331240|NCT00803283|P2|Participant Flow|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331241|NCT00803283|P1|Participant Flow|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331242|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331243|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331244|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331245|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331246|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331247|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331248|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331249|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331250|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331251|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331252|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331253|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331254|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331255|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331256|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331257|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331258|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331304|NCT00803101|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331259|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331260|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331261|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331262|NCT00803283|E2|Reported Event|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331263|NCT00803283|E1|Reported Event|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
331264|NCT00803270|B3|Baseline|Total|Total of all reporting groups
331265|NCT00803270|B2|Baseline|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
331266|NCT00803270|B1|Baseline|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
331267|NCT00803270|P2|Participant Flow|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and~Behavioral therapy."
331268|NCT00803270|P1|Participant Flow|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
331269|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
331270|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
331271|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
331272|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
331273|NCT00803270|E2|Reported Event|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
331274|NCT00803270|E1|Reported Event|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
331275|NCT00803244|B3|Baseline|Total|Total of all reporting groups
331276|NCT00803244|B2|Baseline|Placebo|Placebo tablet
331277|NCT00803244|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
331278|NCT00803244|P2|Participant Flow|Placebo|Placebo tablet
331279|NCT00803244|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
331280|NCT00803244|O2|Outcome|Placebo|Placebo tablet
331281|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
331282|NCT00803244|O2|Outcome|Placebo|Placebo tablet
331283|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
331284|NCT00803244|E2|Reported Event|Placebo|Placebo tablet
331285|NCT00803244|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
331286|NCT00803179|B1|Baseline|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
331287|NCT00803179|P1|Participant Flow|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
331288|NCT00803179|O1|Outcome|Growth Hormone Therapy|"Nutropin Aqueous (AQ):~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
331289|NCT00803179|E1|Reported Event|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
331290|NCT00803114|B3|Baseline|Total|Total of all reporting groups
331291|NCT00803114|B2|Baseline|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331292|NCT00803114|B1|Baseline|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331293|NCT00803114|P2|Participant Flow|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331294|NCT00803114|P1|Participant Flow|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331295|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331296|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331297|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331298|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331299|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331300|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331301|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
331302|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
331303|NCT00803101|B3|Baseline|Total|Total of all reporting groups
331305|NCT00803101|B1|Baseline|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331306|NCT00803101|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331307|NCT00803101|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
331308|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331309|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331310|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331311|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331312|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331313|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331314|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331315|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331316|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331317|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331318|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331319|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331320|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331321|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331322|NCT00803101|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
331323|NCT00803101|E1|Reported Event|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
331324|NCT00803062|B5|Baseline|Total|Total of all reporting groups
331325|NCT00803062|B4|Baseline|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331326|NCT00803062|B3|Baseline|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331327|NCT00803062|B2|Baseline|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331328|NCT00803062|B1|Baseline|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331329|NCT00803062|P4|Participant Flow|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331330|NCT00803062|P3|Participant Flow|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331331|NCT00803062|P2|Participant Flow|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331332|NCT00803062|P1|Participant Flow|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331333|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331334|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331335|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331336|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331337|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331338|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331339|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331340|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331341|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331342|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331343|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331344|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331345|NCT00803062|E4|Reported Event|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331346|NCT00803062|E3|Reported Event|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
331347|NCT00803062|E2|Reported Event|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
331348|NCT00803062|E1|Reported Event|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
331349|NCT00803049|B5|Baseline|Total|Total of all reporting groups
331350|NCT00803049|B4|Baseline|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331351|NCT00803049|B3|Baseline|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331352|NCT00803049|B2|Baseline|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331353|NCT00803049|B1|Baseline|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331354|NCT00803049|P4|Participant Flow|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331355|NCT00803049|P3|Participant Flow|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331356|NCT00803049|P2|Participant Flow|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331357|NCT00803049|P1|Participant Flow|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331358|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331359|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331360|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331361|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331362|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331363|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331394|NCT00803023|P1|Participant Flow|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
331364|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331365|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331366|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331367|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331368|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331369|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331370|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331371|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331372|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331373|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331374|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331375|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331376|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331377|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331378|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331379|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
331380|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
331381|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331382|NCT00803049|E4|Reported Event|Teriflunomide 14 mg/14 mg|"Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
331383|NCT00803049|E3|Reported Event|Placebo/Teriflunomide 14 mg|"Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis."
331384|NCT00803049|E2|Reported Event|Teriflunomide 7 mg/7 mg|"Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.~Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
331385|NCT00803049|E1|Reported Event|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
331386|NCT00803023|B5|Baseline|Total|Total of all reporting groups
331387|NCT00803023|B4|Baseline|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
331388|NCT00803023|B3|Baseline|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
331389|NCT00803023|B2|Baseline|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
331390|NCT00803023|B1|Baseline|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
331391|NCT00803023|P4|Participant Flow|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
331392|NCT00803023|P3|Participant Flow|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
331393|NCT00803023|P2|Participant Flow|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
331395|NCT00803023|O4|Outcome|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
331396|NCT00803023|O3|Outcome|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
331397|NCT00803023|O2|Outcome|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
331398|NCT00803023|O1|Outcome|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
331399|NCT00803023|E4|Reported Event|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
331400|NCT00803023|E3|Reported Event|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
331401|NCT00803023|E2|Reported Event|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
331402|NCT00803023|E1|Reported Event|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
331403|NCT00803010|B3|Baseline|Total|Total of all reporting groups
331404|NCT00803010|B2|Baseline|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331405|NCT00803010|B1|Baseline|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331406|NCT00803010|P2|Participant Flow|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331407|NCT00803010|P1|Participant Flow|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331408|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331409|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331410|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331411|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331412|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331413|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331414|NCT00803010|E2|Reported Event|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
331415|NCT00803010|E1|Reported Event|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
331416|NCT00802997|B3|Baseline|Total|Total of all reporting groups
331417|NCT00802997|B2|Baseline|Sham Procedure|
331418|NCT00802997|B1|Baseline|Lateral Branch Neurotomy|
331419|NCT00802997|P2|Participant Flow|Sham Procedure|The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
331420|NCT00802997|P1|Participant Flow|Lateral Branch Neurotomy|The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
331421|NCT00802997|O2|Outcome|Sham Procedure|
331422|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
331423|NCT00802997|O2|Outcome|Sham Procedure|
331424|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
331425|NCT00802997|O2|Outcome|Sham Procedure|
331426|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
331427|NCT00802997|E2|Reported Event|Sham Procedure|
331428|NCT00802997|E1|Reported Event|Lateral Branch Neurotomy|
331429|NCT00802880|B1|Baseline|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331430|NCT00802880|P1|Participant Flow|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331431|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331432|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331433|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331434|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331435|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331436|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331437|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331438|NCT00802880|O4|Outcome|Total|
331439|NCT00802880|O3|Outcome|Progressive Metabolic Disease|
331440|NCT00802880|O2|Outcome|Stable Metabolic Disease|
331441|NCT00802880|O1|Outcome|Partial Metabolic Response|
331442|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331443|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331444|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331445|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331446|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331447|NCT00802880|E1|Reported Event|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
331448|NCT00802867|B1|Baseline|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331449|NCT00802867|P1|Participant Flow|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331450|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331451|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331452|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331453|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331454|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331455|NCT00802867|E1|Reported Event|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
331456|NCT00802841|B3|Baseline|Total|Total of all reporting groups
331457|NCT00802841|B2|Baseline|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331458|NCT00802841|B1|Baseline|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331459|NCT00802841|P2|Participant Flow|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331460|NCT00802841|P1|Participant Flow|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331461|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331462|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331463|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331464|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331465|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331466|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331467|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331468|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331469|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331470|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331471|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331472|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331473|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331474|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331475|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331476|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331477|NCT00802841|E4|Reported Event|Cross-over to Imatinib|600 mg QD
331478|NCT00802841|E3|Reported Event|Cross-over to Nilotinib|Nilotinib 400 mg BID
331479|NCT00802841|E2|Reported Event|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
331480|NCT00802841|E1|Reported Event|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
331481|NCT00802737|B4|Baseline|Total|Total of all reporting groups
331482|NCT00802737|B3|Baseline|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331565|NCT00802659|B2|Baseline|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331635|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331483|NCT00802737|B2|Baseline|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331484|NCT00802737|B1|Baseline|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331485|NCT00802737|P3|Participant Flow|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331486|NCT00802737|P2|Participant Flow|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331487|NCT00802737|P1|Participant Flow|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331488|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
331489|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331490|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331491|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331492|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331761|NCT00802074|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
331493|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331494|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331495|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331496|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331497|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331498|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331499|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331500|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331501|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
331502|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331762|NCT00802074|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
331503|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331504|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331505|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331506|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331507|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331508|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331509|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331510|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331511|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331704|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331512|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331513|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331514|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331515|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331516|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331517|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331518|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331519|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331520|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331705|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331521|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331522|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331523|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331524|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331525|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331526|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331527|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331528|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331529|NCT00802737|E3|Reported Event|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
331706|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331530|NCT00802737|E2|Reported Event|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
331531|NCT00802737|E1|Reported Event|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
331532|NCT00802685|B3|Baseline|Total|Total of all reporting groups
331533|NCT00802685|B2|Baseline|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
331534|NCT00802685|B1|Baseline|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
331535|NCT00802685|P2|Participant Flow|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
331536|NCT00802685|P1|Participant Flow|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
331537|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
331566|NCT00802659|B1|Baseline|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331567|NCT00802659|P4|Participant Flow|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331538|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
331539|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
331540|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
331541|NCT00802685|E2|Reported Event|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
331542|NCT00802685|E1|Reported Event|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
331543|NCT00802672|B4|Baseline|Total|Total of all reporting groups
331544|NCT00802672|B3|Baseline|Vehicle Product|placebo
331545|NCT00802672|B2|Baseline|Reference Product|Loprox Cream
331546|NCT00802672|B1|Baseline|Test Product|Ciclopirox cream
331547|NCT00802672|P3|Participant Flow|Vehicle Product|placebo
331548|NCT00802672|P2|Participant Flow|Reference Product|Loprox Cream
331549|NCT00802672|P1|Participant Flow|Test Product|Ciclopirox cream
331550|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
331551|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
331552|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
331553|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
331554|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
331555|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
331556|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
331557|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
331558|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
331559|NCT00802672|E3|Reported Event|Vehicle Product|Vehicle
331560|NCT00802672|E2|Reported Event|Reference Product|Loprox® (ciclopirox) Cream 0.77%
331561|NCT00802672|E1|Reported Event|Test Product|Ciclopirox Olamine Cream, USP
331562|NCT00802659|B5|Baseline|Total|Total of all reporting groups
331563|NCT00802659|B4|Baseline|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331564|NCT00802659|B3|Baseline|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331568|NCT00802659|P3|Participant Flow|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331569|NCT00802659|P2|Participant Flow|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331570|NCT00802659|P1|Participant Flow|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331571|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331572|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331573|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331574|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331575|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331576|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331577|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331578|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331579|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331580|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331581|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331582|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331583|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331584|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331585|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331586|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331587|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331588|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331589|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331590|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331591|NCT00802659|E4|Reported Event|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331592|NCT00802659|E3|Reported Event|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331593|NCT00802659|E2|Reported Event|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331594|NCT00802659|E1|Reported Event|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
331595|NCT00802633|B3|Baseline|Total|Total of all reporting groups
331596|NCT00802633|B2|Baseline|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
331597|NCT00802633|B1|Baseline|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
331598|NCT00802633|P2|Participant Flow|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
331599|NCT00802633|P1|Participant Flow|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
331600|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
331601|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
331602|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
331603|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
331604|NCT00802633|E2|Reported Event|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
331605|NCT00802633|E1|Reported Event|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
331606|NCT00802529|B3|Baseline|Total|Total of all reporting groups
331607|NCT00802529|B2|Baseline|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
331608|NCT00802529|B1|Baseline|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
331609|NCT00802529|P2|Participant Flow|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.Each injection was 40mg/ml.
331610|NCT00802529|P1|Participant Flow|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
331611|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
331612|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
331613|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
331614|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
331615|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
331616|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
331617|NCT00802529|E2|Reported Event|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
331618|NCT00802529|E1|Reported Event|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
331619|NCT00802503|B3|Baseline|Total|Total of all reporting groups
331763|NCT00802074|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
331620|NCT00802503|B2|Baseline|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331621|NCT00802503|B1|Baseline|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
331622|NCT00802503|P2|Participant Flow|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331623|NCT00802503|P1|Participant Flow|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
331624|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331625|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
331626|NCT00802503|O2|Outcome|SPN gr|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331627|NCT00802503|O1|Outcome|Controle gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331628|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331629|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331630|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331631|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331632|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331633|NCT00802503|O1|Outcome|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331634|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331636|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331637|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331638|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331639|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331640|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331641|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
331642|NCT00802503|E2|Reported Event|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
331643|NCT00802503|E1|Reported Event|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
331644|NCT00802412|B3|Baseline|Total|Total of all reporting groups
331645|NCT00802412|B2|Baseline|Placebo|Received placebo
331646|NCT00802412|B1|Baseline|Topiramate|Received active topiramate
331647|NCT00802412|P2|Participant Flow|Placebo|"90 participants, will receive matching placebo~Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design."
331648|NCT00802412|P1|Participant Flow|Topiramate|"The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.~Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days)."
331649|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
331650|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
331651|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
331652|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
331653|NCT00802412|E2|Reported Event|Placebo|
331654|NCT00802412|E1|Reported Event|Topiramate|
331655|NCT00802360|B5|Baseline|Total|Total of all reporting groups
331656|NCT00802360|B4|Baseline|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331657|NCT00802360|B3|Baseline|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331658|NCT00802360|B2|Baseline|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
332146|NCT00799604|B4|Baseline|Total|Total of all reporting groups
331659|NCT00802360|B1|Baseline|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331660|NCT00802360|P4|Participant Flow|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331661|NCT00802360|P3|Participant Flow|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331662|NCT00802360|P2|Participant Flow|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331663|NCT00802360|P1|Participant Flow|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331664|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331665|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331666|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331667|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331668|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331669|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331670|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331671|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331672|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331707|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331981|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331673|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331674|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331675|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331676|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331677|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331678|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331679|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331680|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331681|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331682|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331683|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331684|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331685|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331686|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331687|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331688|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331689|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331690|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331691|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331692|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331693|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331694|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331695|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331696|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331697|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
331698|NCT00802360|E4|Reported Event|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331699|NCT00802360|E3|Reported Event|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331700|NCT00802360|E2|Reported Event|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331701|NCT00802360|E1|Reported Event|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
331702|NCT00802178|B1|Baseline|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331703|NCT00802178|P1|Participant Flow|Mirapexin® (Pramipexole)|"The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.~mode of administration (admin.): Tablets for oral use"
331764|NCT00802074|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
331708|NCT00802178|E1|Reported Event|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
331709|NCT00802100|B4|Baseline|Total|Total of all reporting groups
331710|NCT00802100|B3|Baseline|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
331711|NCT00802100|B2|Baseline|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
331712|NCT00802100|B1|Baseline|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
331713|NCT00802100|P3|Participant Flow|Aripiprazole|"Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.~Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
331714|NCT00802100|P2|Participant Flow|Perphenazine|"Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.~Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
331715|NCT00802100|P1|Participant Flow|Olanzapine|"Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.~Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day"
331716|NCT00802100|O3|Outcome|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
331717|NCT00802100|O2|Outcome|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
331718|NCT00802100|O1|Outcome|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
331719|NCT00802100|O1|Outcome|Overall Study|This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
331720|NCT00802100|E3|Reported Event|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
331721|NCT00802100|E2|Reported Event|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
331722|NCT00802100|E1|Reported Event|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
331723|NCT00802074|B7|Baseline|Total|Total of all reporting groups
331724|NCT00802074|B6|Baseline|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331725|NCT00802074|B5|Baseline|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331726|NCT00802074|B4|Baseline|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331727|NCT00802074|B3|Baseline|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331728|NCT00802074|B2|Baseline|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331729|NCT00802074|B1|Baseline|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331730|NCT00802074|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
331731|NCT00802074|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
331732|NCT00802074|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
331733|NCT00802074|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
331734|NCT00802074|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
331735|NCT00802074|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
331736|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331737|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331760|NCT00802074|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
331738|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
331739|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331740|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331741|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
331742|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331743|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331744|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
331745|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331746|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331747|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
331748|NCT00802074|O6|Outcome|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331749|NCT00802074|O5|Outcome|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331750|NCT00802074|O4|Outcome|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331751|NCT00802074|O3|Outcome|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331752|NCT00802074|O2|Outcome|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331753|NCT00802074|O1|Outcome|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
331754|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331755|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331756|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
331757|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
331758|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
331759|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
332140|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
331765|NCT00802074|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
331766|NCT00801983|B3|Baseline|Total|Total of all reporting groups
331767|NCT00801983|B2|Baseline|Group B|Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
331768|NCT00801983|B1|Baseline|Group A|Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
331769|NCT00801983|P2|Participant Flow|Group B (Alternative/Typical)|Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study
331770|NCT00801983|P1|Participant Flow|Group A (Typical/Alternative)|Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
331771|NCT00801983|O2|Outcome|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
331772|NCT00801983|O1|Outcome|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
331773|NCT00801983|E2|Reported Event|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
331774|NCT00801983|E1|Reported Event|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
331775|NCT00801892|B3|Baseline|Total|Total of all reporting groups
331776|NCT00801892|B2|Baseline|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331777|NCT00801892|B1|Baseline|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331778|NCT00801892|P2|Participant Flow|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331779|NCT00801892|P1|Participant Flow|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331780|NCT00801892|O2|Outcome|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331781|NCT00801892|O1|Outcome|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331782|NCT00801892|E2|Reported Event|2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331783|NCT00801892|E1|Reported Event|1 Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
331784|NCT00801801|B1|Baseline|Metronomic Taxotere and Nexavar|
331785|NCT00801801|P1|Participant Flow|Metronomic Taxotere and Nexavar|
331786|NCT00801801|O1|Outcome|Metronomic Taxotere + Nexavar|Non-randomized, open-label, phase II study of metronomic chemotherapy (docetaxel) plus sorafenib as first line therapy for subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status
331787|NCT00801801|E1|Reported Event|Metronomic Taxotere and Nexavar|
331788|NCT00801684|B1|Baseline|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
331789|NCT00801684|P1|Participant Flow|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
331790|NCT00801684|O4|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331791|NCT00801684|O3|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
332141|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
331792|NCT00801684|O2|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331793|NCT00801684|O1|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
331794|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
331795|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
331796|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
331797|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331798|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331799|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
331800|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
331801|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
331802|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331803|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331804|NCT00801684|E6|Reported Event|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
331825|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
332142|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
331805|NCT00801684|E5|Reported Event|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331806|NCT00801684|E4|Reported Event|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
331807|NCT00801684|E3|Reported Event|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
331808|NCT00801684|E2|Reported Event|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
331809|NCT00801684|E1|Reported Event|Overall Study|
331810|NCT00801632|B1|Baseline|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331811|NCT00801632|P1|Participant Flow|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331812|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331813|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331814|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331922|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331815|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331816|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331817|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331818|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331819|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331820|NCT00801632|E1|Reported Event|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
331821|NCT00801242|B1|Baseline|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331822|NCT00801242|P1|Participant Flow|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331823|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331824|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331923|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331924|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331826|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331827|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331828|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331829|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331830|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
331831|NCT00801242|E1|Reported Event|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
331832|NCT00801229|B3|Baseline|Total|Total of all reporting groups
331833|NCT00801229|B2|Baseline|Placebo|
331834|NCT00801229|B1|Baseline|Vyvanse|
331835|NCT00801229|P2|Participant Flow|Placebo|
331836|NCT00801229|P1|Participant Flow|Vyvanse|
331837|NCT00801229|O2|Outcome|Placebo|
331838|NCT00801229|O1|Outcome|Vyvanse|
331839|NCT00801229|E2|Reported Event|Placebo|
331840|NCT00801229|E1|Reported Event|Vyvanse|
331841|NCT00801099|B1|Baseline|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
331842|NCT00801099|P1|Participant Flow|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
331843|NCT00801099|O1|Outcome|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
331844|NCT00801099|E1|Reported Event|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
331845|NCT00800982|B3|Baseline|Total|Total of all reporting groups
331846|NCT00800982|B2|Baseline|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
331847|NCT00800982|B1|Baseline|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
331848|NCT00800982|P2|Participant Flow|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff."
331849|NCT00800982|P1|Participant Flow|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
331850|NCT00800982|O2|Outcome|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
331851|NCT00800982|O1|Outcome|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
331852|NCT00800982|E2|Reported Event|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
332143|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
331853|NCT00800982|E1|Reported Event|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
331854|NCT00800865|B3|Baseline|Total|Total of all reporting groups
331855|NCT00800865|B2|Baseline|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
331856|NCT00800865|B1|Baseline|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
331857|NCT00800865|P2|Participant Flow|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
331858|NCT00800865|P1|Participant Flow|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
331859|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
331860|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
331861|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
331862|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
331863|NCT00800865|E2|Reported Event|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
331864|NCT00800865|E1|Reported Event|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
331865|NCT00800839|B1|Baseline|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331866|NCT00800839|P1|Participant Flow|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331867|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331868|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331869|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331870|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331871|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331925|NCT00800683|E2|Reported Event|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331926|NCT00800683|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
331927|NCT00800540|B1|Baseline|Overall|All enrolled
331872|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331873|NCT00800839|E1|Reported Event|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
331874|NCT00800735|B1|Baseline|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
331875|NCT00800735|P1|Participant Flow|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
331876|NCT00800735|O1|Outcome|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
331877|NCT00800735|E1|Reported Event|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
331878|NCT00800683|B3|Baseline|Total|Total of all reporting groups
331879|NCT00800683|B2|Baseline|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331880|NCT00800683|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
331881|NCT00800683|P2|Participant Flow|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331882|NCT00800683|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
331883|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331884|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331885|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331886|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331887|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331888|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331889|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331890|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331891|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331892|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331893|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331894|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331895|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331896|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331897|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331898|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331899|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331900|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331901|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331902|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331903|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331904|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331905|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331906|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331907|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331908|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331909|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331910|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331911|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331912|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331913|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331914|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331915|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331916|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331917|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331918|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331919|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331920|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
331921|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
331928|NCT00800540|P2|Participant Flow|COMBIGAN/AZARGA|COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
331929|NCT00800540|P1|Participant Flow|AZARGA/COMBIGAN|AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
331930|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331931|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331932|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331933|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331934|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331935|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331936|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331937|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331938|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331939|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331940|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331941|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331942|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331943|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331944|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331945|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331946|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331947|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331948|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331949|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331950|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331951|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331952|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331953|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331954|NCT00800540|E2|Reported Event|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331955|NCT00800540|E1|Reported Event|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
331956|NCT00800436|B8|Baseline|Total|Total of all reporting groups
331957|NCT00800436|B7|Baseline|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331958|NCT00800436|B6|Baseline|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331959|NCT00800436|B5|Baseline|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331960|NCT00800436|B4|Baseline|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331961|NCT00800436|B3|Baseline|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
331962|NCT00800436|B2|Baseline|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331963|NCT00800436|B1|Baseline|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
331964|NCT00800436|P7|Participant Flow|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331965|NCT00800436|P6|Participant Flow|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331966|NCT00800436|P5|Participant Flow|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331967|NCT00800436|P4|Participant Flow|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331968|NCT00800436|P3|Participant Flow|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
331969|NCT00800436|P2|Participant Flow|Part 1: Cohort 2|Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331970|NCT00800436|P1|Participant Flow|Part 1: Cohort 1|Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
331971|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331972|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331973|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331974|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331975|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
331976|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331977|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
331978|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331979|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331980|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331982|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
331983|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331984|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
331985|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331986|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331987|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331988|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331989|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
331990|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331991|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
331992|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
331993|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
331994|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
331995|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
331996|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
331997|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
331998|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
331999|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
332000|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
332001|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
332002|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
332003|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
332004|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
332005|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
332006|NCT00800436|E7|Reported Event|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
332007|NCT00800436|E6|Reported Event|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
332008|NCT00800436|E5|Reported Event|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
332009|NCT00800436|E4|Reported Event|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
332010|NCT00800436|E3|Reported Event|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
332011|NCT00800436|E2|Reported Event|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
332012|NCT00800436|E1|Reported Event|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
332013|NCT00800384|B3|Baseline|Total|Total of all reporting groups
332014|NCT00800384|B2|Baseline|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
332015|NCT00800384|B1|Baseline|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
332016|NCT00800384|P2|Participant Flow|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
332017|NCT00800384|P1|Participant Flow|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
332018|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
332019|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
332020|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
332021|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
332022|NCT00800384|E2|Reported Event|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
332023|NCT00800384|E1|Reported Event|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
332024|NCT00800254|B3|Baseline|Total|Total of all reporting groups
332025|NCT00800254|B2|Baseline|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332026|NCT00800254|B1|Baseline|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332027|NCT00800254|P2|Participant Flow|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332028|NCT00800254|P1|Participant Flow|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332029|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332030|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332031|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332032|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332033|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332034|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332035|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332036|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332037|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332038|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332039|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332040|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332041|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332042|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332043|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332044|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332045|NCT00800254|E2|Reported Event|Standard Rehabilitation Protocol|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
332046|NCT00800254|E1|Reported Event|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
332047|NCT00800202|B3|Baseline|Total|Total of all reporting groups
332048|NCT00800202|B2|Baseline|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332049|NCT00800202|B1|Baseline|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332050|NCT00800202|P2|Participant Flow|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332051|NCT00800202|P1|Participant Flow|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332052|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332053|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332054|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332055|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332056|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332057|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
333251|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
332058|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332059|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332060|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332061|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332062|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332063|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332064|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332065|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332066|NCT00800202|E2|Reported Event|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
332067|NCT00800202|E1|Reported Event|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
332068|NCT00798967|B3|Baseline|Total|Total of all reporting groups
332069|NCT00798967|B2|Baseline|Placebo|Matching sc dose of placebo to teduglutide
332070|NCT00798967|B1|Baseline|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
332071|NCT00798967|P2|Participant Flow|Placebo|Matching sc dose of placebo to teduglutide
332072|NCT00798967|P1|Participant Flow|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
332073|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
332074|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day sc dose of teduglutide
332075|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
332076|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
332077|NCT00798967|E2|Reported Event|Placebo|Matching sc dose of placebo to teduglutide
332078|NCT00798967|E1|Reported Event|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
332079|NCT00798889|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
332080|NCT00798889|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
332081|NCT00798889|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
332082|NCT00798889|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
332083|NCT00799825|B1|Baseline|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332084|NCT00799825|P1|Participant Flow|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332085|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332144|NCT00799643|E2|Reported Event|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
332145|NCT00799643|E1|Reported Event|Placebo|Placebo for salsalate, orally, divided dosing
332086|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332087|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332088|NCT00799825|E1|Reported Event|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
332089|NCT00799773|B3|Baseline|Total|Total of all reporting groups
332090|NCT00799773|B2|Baseline|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332091|NCT00799773|B1|Baseline|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332092|NCT00799773|P2|Participant Flow|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332093|NCT00799773|P1|Participant Flow|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332094|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332095|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332096|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332097|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332098|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332099|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332100|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332101|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332102|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332103|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332104|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332105|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332106|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332107|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332108|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332109|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332110|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332111|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332112|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332113|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332114|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332115|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332116|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332117|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332118|NCT00799773|E2|Reported Event|Standard of Care|Participants will receive plasma exchange and corticosteroids.
332119|NCT00799773|E1|Reported Event|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
332120|NCT00799708|B4|Baseline|Total|Total of all reporting groups
332121|NCT00799708|B3|Baseline|Placebo|Placebo capsule once daily for 7 days.
332122|NCT00799708|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
332123|NCT00799708|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
332124|NCT00799708|P3|Participant Flow|Placebo|Placebo capsule once daily for 7 days.
332125|NCT00799708|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
332126|NCT00799708|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
332127|NCT00799708|O2|Outcome|Placebo|
332128|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|
332129|NCT00799708|O3|Outcome|Placebo|Placebo capsule once daily for 7 days.
332130|NCT00799708|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
332131|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
332132|NCT00799708|E3|Reported Event|Placebo|Placebo capsule once daily for 7 days.
332133|NCT00799708|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
332134|NCT00799708|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
332135|NCT00799643|B3|Baseline|Total|Total of all reporting groups
332136|NCT00799643|B2|Baseline|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
332137|NCT00799643|B1|Baseline|Placebo|Placebo for salsalate, orally, divided dosing
332138|NCT00799643|P2|Participant Flow|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
332139|NCT00799643|P1|Participant Flow|Placebo|Placebo for salsalate, orally, divided dosing
332147|NCT00799604|B3|Baseline|Cohort 3: Clevidipine 125 μg ( mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332148|NCT00799604|B2|Baseline|Cohort 2: Clevidipine 500 μg (1.0 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332149|NCT00799604|B1|Baseline|Cohort 1: Clevidipine 250 μg (0.5 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332150|NCT00799604|P3|Participant Flow|Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.
332151|NCT00799604|P2|Participant Flow|Planned Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.
332152|NCT00799604|P1|Participant Flow|Planned Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.
332153|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332154|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332155|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332156|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332157|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332158|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332159|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332160|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332161|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332162|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332163|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332164|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332165|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332166|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332167|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332168|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332169|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332170|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332171|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332172|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332173|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
332174|NCT00799604|E1|Reported Event|All Participants Across All Cohorts and Treatment Periods|Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
332175|NCT00799591|B1|Baseline|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332176|NCT00799591|P1|Participant Flow|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332177|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332178|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332179|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332180|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332181|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332182|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332183|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332184|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332185|NCT00799591|E1|Reported Event|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
332186|NCT00799578|B1|Baseline|Cystagon-EC|
332187|NCT00799578|P1|Participant Flow|Cystagon-EC|
332188|NCT00799578|O1|Outcome|Number of Improved Subjects|
332189|NCT00799578|E1|Reported Event|Number of Improved Subjects|
332190|NCT00799487|B4|Baseline|Total|Total of all reporting groups
332191|NCT00799487|B3|Baseline|Concerta/Placebo|Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
332192|NCT00799487|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
332193|NCT00799487|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
332194|NCT00799487|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
332195|NCT00799487|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
332196|NCT00799487|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
332197|NCT00799487|O3|Outcome|Concerta|Chilfdren randomized to receive Concerta at lab school day 1 or lab school day 2
332198|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332199|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332200|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332201|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332202|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332203|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332204|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332205|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332206|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332207|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332208|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332209|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332210|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332211|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332212|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332213|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332214|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332215|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332216|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332217|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332218|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332219|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332220|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332221|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332222|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332223|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332224|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332225|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332226|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332227|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332228|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332229|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332230|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332231|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332232|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332233|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332234|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332235|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332236|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332237|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332238|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332239|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332240|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332241|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332242|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332243|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332244|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332245|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332246|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332247|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332248|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332249|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or at lab school day 2
332250|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332251|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332252|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332253|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332254|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332255|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332256|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332257|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332258|NCT00799487|O2|Outcome|Placebo|Chidren randomized to receive Placebo at lab school day 1 or lab school day 2
332259|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332260|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332261|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332262|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332263|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332264|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332265|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332266|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332267|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332268|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332269|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332270|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332271|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332272|NCT00799487|E3|Reported Event|Open Label|dose adjustment period and double blind period other than lab school day
332273|NCT00799487|E2|Reported Event|Concerta|Concerta was received during the lab school day
332274|NCT00799487|E1|Reported Event|Placebo|Placebo was received during the lab school day
332275|NCT00799474|B1|Baseline|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332276|NCT00799474|P1|Participant Flow|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332277|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332278|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332279|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332280|NCT00799474|E1|Reported Event|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
332281|NCT00799422|B1|Baseline|Overall|Baseline characteristics are presented for all participants completing all three treatment sequences.
332282|NCT00799422|P6|Participant Flow|Clear Care / Complete / ReNu|Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
332283|NCT00799422|P5|Participant Flow|Complete / ReNu / Clear Care|Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
332284|NCT00799422|P4|Participant Flow|ReNu / Clear Care / Complete|ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
332285|NCT00799422|P3|Participant Flow|Clear Care / ReNu / Complete|Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
332286|NCT00799422|P2|Participant Flow|Complete / Clear Care / ReNu|Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
332287|NCT00799422|P1|Participant Flow|ReNu / Complete / Clear Care|ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
332288|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
332289|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
332290|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
332291|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
332292|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
332293|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
332294|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
332295|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
332296|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
332297|NCT00799422|E3|Reported Event|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
332298|NCT00799422|E2|Reported Event|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
332299|NCT00799422|E1|Reported Event|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
332300|NCT00799409|B4|Baseline|Total|Total of all reporting groups
332301|NCT00799409|B3|Baseline|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
332302|NCT00799409|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
332303|NCT00799409|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
332304|NCT00799409|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
332305|NCT00799409|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
332306|NCT00799409|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
332307|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332308|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332309|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332310|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332311|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332312|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332313|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332314|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332315|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332316|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332317|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332318|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332319|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332320|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332321|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332322|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332323|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332324|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332325|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332326|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332327|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332328|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332329|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332330|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332331|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332332|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332333|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332334|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332335|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332336|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332337|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332338|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332339|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332340|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332341|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332342|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332343|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332344|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332345|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332346|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332347|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332348|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332349|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332350|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332351|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332352|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332353|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332354|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332355|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332356|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332357|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332358|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332359|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332360|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332361|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332362|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332363|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332364|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332365|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332366|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332367|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332368|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332369|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332370|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332371|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332372|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332373|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332374|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332375|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332376|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332377|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332378|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332379|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
332380|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
332381|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
332382|NCT00799409|E3|Reported Event|Open Label/Non-Lab Day CONCERTA|Dose adjustment period and double blind period other than lab school day
332383|NCT00799409|E2|Reported Event|Concerta|Concerta was received during the lab school day
332384|NCT00799409|E1|Reported Event|Placebo|Placebo was received during the lab school day
332385|NCT00799396|B1|Baseline|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
332386|NCT00799396|P1|Participant Flow|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
332387|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
332388|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
332389|NCT00799396|E1|Reported Event|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
332390|NCT00799292|B3|Baseline|Total|Total of all reporting groups
332391|NCT00799292|B2|Baseline|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
332392|NCT00799292|B1|Baseline|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
332393|NCT00799292|P2|Participant Flow|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
332394|NCT00799292|P1|Participant Flow|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
332395|NCT00799292|O2|Outcome|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
332396|NCT00799292|O1|Outcome|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
332397|NCT00799227|B1|Baseline|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332398|NCT00799227|P1|Participant Flow|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332399|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332400|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332401|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332402|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332403|NCT00799227|E1|Reported Event|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
332404|NCT00798759|B3|Baseline|Total|Total of all reporting groups
332405|NCT00798759|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
332406|NCT00798759|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
332407|NCT00798759|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
332408|NCT00798759|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
332409|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332410|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332411|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332412|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332413|NCT00798759|E2|Reported Event|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332414|NCT00798759|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
332415|NCT00798720|B1|Baseline|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332416|NCT00798720|P1|Participant Flow|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332417|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332418|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332419|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332420|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332421|NCT00798720|E1|Reported Event|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
332422|NCT00798707|B4|Baseline|Total|Total of all reporting groups
332423|NCT00798707|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332424|NCT00798707|B2|Baseline|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332425|NCT00798707|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332426|NCT00798707|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332427|NCT00798707|P2|Participant Flow|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332428|NCT00798707|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332429|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332430|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332431|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332432|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332433|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332434|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332435|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332436|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332437|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332438|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332439|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332440|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332441|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332442|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332443|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332444|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332445|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332446|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332447|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332448|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332449|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332450|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332451|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332452|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332453|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332454|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332455|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332456|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332457|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332458|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332459|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332460|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332461|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332462|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332463|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332464|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332465|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332466|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332467|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332468|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332469|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332470|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332471|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332472|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332473|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332474|NCT00798707|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
332475|NCT00798707|E2|Reported Event|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
332476|NCT00798707|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
332477|NCT00798655|B1|Baseline|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
332478|NCT00798655|P1|Participant Flow|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
332479|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
332480|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
332481|NCT00798655|E1|Reported Event|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
332482|NCT00798603|B1|Baseline|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332483|NCT00798603|P1|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332484|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332485|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332486|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332487|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332488|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332489|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
333252|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
332490|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332491|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332492|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332493|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332494|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332495|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332496|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332497|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332498|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332499|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332500|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332501|NCT00798603|E1|Reported Event|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
332502|NCT00798577|B3|Baseline|Total|Total of all reporting groups
332503|NCT00798577|B2|Baseline|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332504|NCT00798577|B1|Baseline|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332505|NCT00798577|P2|Participant Flow|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332506|NCT00798577|P1|Participant Flow|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332507|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332508|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332509|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332510|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332511|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332512|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332513|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332514|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332515|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332516|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332517|NCT00798577|E2|Reported Event|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
332518|NCT00798577|E1|Reported Event|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
332519|NCT00798486|B1|Baseline|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332520|NCT00798486|P1|Participant Flow|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332521|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332522|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332523|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332524|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332525|NCT00798486|E1|Reported Event|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
332526|NCT00798434|B3|Baseline|Total|Total of all reporting groups
332527|NCT00798434|B2|Baseline|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332528|NCT00798434|B1|Baseline|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332529|NCT00798434|P2|Participant Flow|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
333253|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
332530|NCT00798434|P1|Participant Flow|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332531|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332532|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332533|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332534|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332535|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332536|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332537|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332538|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332539|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332540|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332541|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332542|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332543|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332544|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332545|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332546|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332547|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332548|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332549|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332550|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332551|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332552|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332553|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332671|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
332672|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
332554|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332555|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332556|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332557|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332558|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332559|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332560|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332561|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332562|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332563|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332564|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332565|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332566|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332567|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332568|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332569|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332570|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332571|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332572|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332573|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332574|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332575|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332576|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332577|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332578|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332579|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332580|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332581|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332582|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332583|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332584|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332585|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332586|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332587|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332588|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332589|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332590|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332591|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332592|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332593|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332594|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332595|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332596|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332597|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332598|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332599|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332600|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332601|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332602|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332603|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
332604|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
332605|NCT00798434|E4|Reported Event|Placebo/Fesoterodine Open-label|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.
332606|NCT00798434|E3|Reported Event|Festerodine/Fesoterodine Open-Label|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.
332607|NCT00798434|E2|Reported Event|Fesoterodine Double-Blind|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)
332608|NCT00798434|E1|Reported Event|Placebo Double-Blind|Participants received matched placebo once daily from baseline to Week 12 (double-blinded)
332609|NCT00798369|B7|Baseline|Total|Total of all reporting groups
332610|NCT00798369|B6|Baseline|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332673|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
332674|NCT00798317|E2|Reported Event|Placebo|Intravitreal injection of placebo
332675|NCT00798317|E1|Reported Event|Ocriplasmin 125ug|125ug ocriplasmin intravitreal injection
332611|NCT00798369|B5|Baseline|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332612|NCT00798369|B4|Baseline|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332613|NCT00798369|B3|Baseline|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332614|NCT00798369|B2|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332615|NCT00798369|B1|Baseline|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332616|NCT00798369|P6|Participant Flow|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332617|NCT00798369|P5|Participant Flow|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332618|NCT00798369|P4|Participant Flow|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332619|NCT00798369|P3|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332620|NCT00798369|P2|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332621|NCT00798369|P1|Participant Flow|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332622|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332623|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332624|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332625|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332626|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332627|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332628|NCT00798369|O1|Outcome|Linear Model|The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).
332629|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332676|NCT00798304|B4|Baseline|Total|Total of all reporting groups
332630|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332631|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332632|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332633|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332634|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332635|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332636|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332637|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332638|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332639|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332640|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332641|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332642|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332643|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332644|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332645|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332646|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332647|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332677|NCT00798304|B3|Baseline|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332678|NCT00798304|B2|Baseline|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332648|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332649|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332650|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332651|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332652|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332653|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332654|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332655|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332656|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332657|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332658|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332659|NCT00798369|E6|Reported Event|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
332660|NCT00798369|E5|Reported Event|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332661|NCT00798369|E4|Reported Event|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332662|NCT00798369|E3|Reported Event|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332663|NCT00798369|E2|Reported Event|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332664|NCT00798369|E1|Reported Event|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
332665|NCT00798317|B3|Baseline|Total|Total of all reporting groups
332666|NCT00798317|B2|Baseline|Placebo|Intravitreal injection of placebo
332667|NCT00798317|B1|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
332668|NCT00798317|P2|Participant Flow|Placebo|Intravitreal injection of placebo
332669|NCT00798317|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
332670|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
333254|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
332679|NCT00798304|B1|Baseline|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332680|NCT00798304|P3|Participant Flow|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332681|NCT00798304|P2|Participant Flow|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332682|NCT00798304|P1|Participant Flow|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332683|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332684|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332685|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332686|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332687|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332688|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332689|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332690|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332691|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332692|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332693|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332694|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332695|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332696|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332697|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332698|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332699|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332700|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332701|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332702|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332703|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332704|NCT00798304|E3|Reported Event|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
332705|NCT00798304|E2|Reported Event|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
332706|NCT00798304|E1|Reported Event|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
332707|NCT00798161|B8|Baseline|Total|Total of all reporting groups
332708|NCT00798161|B7|Baseline|L2.5+M1000BID (Open Label)|Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
332709|NCT00798161|B6|Baseline|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332710|NCT00798161|B5|Baseline|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332711|NCT00798161|B4|Baseline|Lina5|Patients treated with Linagliptin 5mg OD
332712|NCT00798161|B3|Baseline|M1000BID|Patients treated with Metformin 1000mg BID
332713|NCT00798161|B2|Baseline|M500BID|Patients treated with Metformin 500mg BID
332714|NCT00798161|B1|Baseline|Placebo|Patients treated with matching placebo
332715|NCT00798161|P7|Participant Flow|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
332716|NCT00798161|P6|Participant Flow|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
332717|NCT00798161|P5|Participant Flow|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
332718|NCT00798161|P4|Participant Flow|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
332719|NCT00798161|P3|Participant Flow|M1000 BID|Patients treated with Metformin 1000 mg BID
332720|NCT00798161|P2|Participant Flow|M500 Twice Daily (BID)|Patients treated with Metformin 500 mg BID
332721|NCT00798161|P1|Participant Flow|Placebo|Patients treated with matching placebo
332722|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332723|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332724|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332725|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332726|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332727|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332728|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
332729|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
332730|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332731|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332732|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332733|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332734|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332735|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332736|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332737|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332738|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332739|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332740|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332741|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332742|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332743|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332744|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332745|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332746|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332747|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332748|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332749|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332750|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332751|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332752|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332753|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332754|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332755|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332756|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332757|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332758|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332759|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332760|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332761|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332762|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332763|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332764|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332765|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332766|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332767|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332768|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332769|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332770|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332771|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332772|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332773|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332774|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332775|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332776|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332777|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332778|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332779|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332780|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332781|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332782|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332783|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332784|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332785|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332786|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332787|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332788|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332789|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332790|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332791|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332792|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332793|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332794|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332795|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332796|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332797|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332798|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332799|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332800|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332801|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332802|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332803|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332804|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332805|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332806|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332807|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332808|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332809|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332810|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332811|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332812|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332813|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332814|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
332815|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
332816|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
332817|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
332818|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
332819|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
332820|NCT00798161|E7|Reported Event|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
332821|NCT00798161|E6|Reported Event|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
332822|NCT00798161|E5|Reported Event|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
332823|NCT00798161|E4|Reported Event|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
332824|NCT00798161|E3|Reported Event|M1000 BID|Patients treated with Metformin 1000 mg bis in die (BID)
332825|NCT00798161|E2|Reported Event|M500 BID|Patients treated with Metformin 500 mg BID
332826|NCT00798161|E1|Reported Event|Placebo|Patients treated with matching placebo
332827|NCT00798135|B1|Baseline|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332828|NCT00798135|P1|Participant Flow|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332829|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332830|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332831|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332832|NCT00798135|E1|Reported Event|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
332833|NCT00798096|B1|Baseline|Overall Study|1-fostamatinib 200mg, BID, Oral
332834|NCT00798096|P1|Participant Flow|Overall Study|1-fostamatinib 200mg, BID, Oral
332835|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
332836|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
332837|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
332838|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
332839|NCT00798096|E1|Reported Event|Overall Study|1-fostamatinib 200mg, BID, Oral
332840|NCT00798018|B5|Baseline|Total|Total of all reporting groups
332841|NCT00798018|B4|Baseline|Tetracaine|1% tetracaine was used to inflate the cuff
332842|NCT00798018|B3|Baseline|Lidocaine|2% lidiocaine was used to inflate the cuff
332843|NCT00798018|B2|Baseline|Normal Saline|normal saline was used to inflate the cuff
332844|NCT00798018|B1|Baseline|Air Alone|Only air was injected into the cuff, as the routine practice
332845|NCT00798018|P4|Participant Flow|Tetracaine|1% tetracaine was used to inflate the cuff
332846|NCT00798018|P3|Participant Flow|Lidocaine|2% lidiocaine was used to inflate the cuff
332847|NCT00798018|P2|Participant Flow|Normal Saline|normal saline was used to inflate the cuff
332848|NCT00798018|P1|Participant Flow|Air Alone|Only air was injected into the cuff, as the routine practice
332849|NCT00798018|O4|Outcome|Tetracaine|1% tetracaine was used to inflate the cuff
332850|NCT00798018|O3|Outcome|Lidocaine|2% lidiocaine was used to inflate the cuff
332851|NCT00798018|O2|Outcome|Normal Saline|normal saline was used to inflate the cuff
332852|NCT00798018|O1|Outcome|Air Alone|Only air was injected into the cuff, as the routine practice
332853|NCT00798018|E4|Reported Event|Tetracaine|1% tetracaine was used to inflate the cuff
332854|NCT00798018|E3|Reported Event|Lidocaine|2% lidiocaine was used to inflate the cuff
332855|NCT00798018|E2|Reported Event|Normal Saline|normal saline was used to inflate the cuff
332856|NCT00798018|E1|Reported Event|Air Alone|Only air was injected into the cuff, as the routine practice
332857|NCT00797966|B5|Baseline|Total|Total of all reporting groups
332858|NCT00797966|B4|Baseline|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332859|NCT00797966|B3|Baseline|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332860|NCT00797966|B2|Baseline|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
332861|NCT00797966|B1|Baseline|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
334090|NCT00795184|O4|Outcome|HDWLE+NBI+pCLE|
332862|NCT00797966|P6|Participant Flow|Participants in Phase A+|Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
332863|NCT00797966|P5|Participant Flow|Participants in Phase A|Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
332864|NCT00797966|P4|Participant Flow|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332865|NCT00797966|P3|Participant Flow|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332866|NCT00797966|P2|Participant Flow|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332867|NCT00797966|P1|Participant Flow|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332868|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332869|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332870|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
332871|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332872|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332873|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332874|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332875|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332876|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332877|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332878|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332879|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332880|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332881|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332882|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
332883|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332884|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332885|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332886|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
332887|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332888|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332889|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332890|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332891|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332892|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332893|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332894|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332895|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332896|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332897|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332898|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332899|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332900|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332901|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332902|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332903|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332904|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332905|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332906|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332907|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332908|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
332909|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332910|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332911|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332912|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332913|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332914|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332915|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332916|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332917|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332918|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332919|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332920|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332921|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332922|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332923|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332924|NCT00797966|E4|Reported Event|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332925|NCT00797966|E3|Reported Event|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332926|NCT00797966|E2|Reported Event|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332927|NCT00797966|E1|Reported Event|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
332928|NCT00797862|B4|Baseline|Total|Total of all reporting groups
332929|NCT00797862|B3|Baseline|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332930|NCT00797862|B2|Baseline|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332931|NCT00797862|B1|Baseline|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332932|NCT00797862|P3|Participant Flow|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332933|NCT00797862|P2|Participant Flow|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332934|NCT00797862|P1|Participant Flow|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332935|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332936|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332937|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332938|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332939|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332940|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332941|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332942|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332943|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332944|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332945|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332946|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332947|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332948|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332949|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332950|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332951|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332968|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
332952|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332953|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332954|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332955|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332956|NCT00797862|E3|Reported Event|Amlodipine|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332957|NCT00797862|E2|Reported Event|Aliskiren|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332958|NCT00797862|E1|Reported Event|Aliskiren + Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
332959|NCT00797823|B4|Baseline|Total|Total of all reporting groups
332960|NCT00797823|B3|Baseline|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
332961|NCT00797823|B2|Baseline|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332962|NCT00797823|B1|Baseline|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332963|NCT00797823|P3|Participant Flow|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
332964|NCT00797823|P2|Participant Flow|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332965|NCT00797823|P1|Participant Flow|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332966|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
332967|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
332969|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
332970|NCT00797823|E3|Reported Event|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
332971|NCT00797823|E2|Reported Event|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332972|NCT00797823|E1|Reported Event|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
332973|NCT00797797|B3|Baseline|Total|Total of all reporting groups
332974|NCT00797797|B2|Baseline|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
332975|NCT00797797|B1|Baseline|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
332976|NCT00797797|P2|Participant Flow|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
332977|NCT00797797|P1|Participant Flow|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
332978|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
332979|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
332980|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
332981|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
332982|NCT00797797|E2|Reported Event|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
332983|NCT00797797|E1|Reported Event|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
332984|NCT00797667|B4|Baseline|Total|Total of all reporting groups
332985|NCT00797667|B3|Baseline|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332986|NCT00797667|B2|Baseline|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
332987|NCT00797667|B1|Baseline|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332988|NCT00797667|P3|Participant Flow|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332989|NCT00797667|P2|Participant Flow|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
332990|NCT00797667|P1|Participant Flow|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332991|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332992|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
332993|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332994|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332995|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
332996|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332997|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
332998|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
332999|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333000|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333001|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
333002|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333003|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333004|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
333005|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333006|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333007|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
333008|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333255|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
333009|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333010|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
333011|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333012|NCT00797667|E3|Reported Event|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333013|NCT00797667|E2|Reported Event|MK-0974 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
333014|NCT00797667|E1|Reported Event|MK-0974 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
333015|NCT00797563|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333016|NCT00797563|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333017|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333018|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333019|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333020|NCT00797563|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
333021|NCT00797511|B1|Baseline|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
333022|NCT00797511|P1|Participant Flow|ADACEL POLIO Vaccine Study Group|Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
333023|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
333024|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
333025|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
333026|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
333027|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
333028|NCT00797511|E1|Reported Event|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
333029|NCT00797459|B1|Baseline|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
333030|NCT00797459|P1|Participant Flow|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
333031|NCT00797459|O2|Outcome|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
333032|NCT00797459|O1|Outcome|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
333033|NCT00797459|O2|Outcome|Restylane-L|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
333034|NCT00797459|O1|Outcome|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
333035|NCT00797459|E2|Reported Event|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
333036|NCT00797459|E1|Reported Event|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
333037|NCT00797316|B3|Baseline|Total|Total of all reporting groups
333038|NCT00797316|B2|Baseline|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333039|NCT00797316|B1|Baseline|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333040|NCT00797316|P2|Participant Flow|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333041|NCT00797316|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333042|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333043|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333044|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333045|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333046|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333047|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333048|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333049|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333050|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333051|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333052|NCT00797316|E2|Reported Event|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
333053|NCT00797316|E1|Reported Event|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
333054|NCT00797277|B3|Baseline|Total|Total of all reporting groups
333055|NCT00797277|B2|Baseline|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
333056|NCT00797277|B1|Baseline|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
333057|NCT00797277|P2|Participant Flow|2. IM Haloperidol Plus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
333058|NCT00797277|P1|Participant Flow|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
333059|NCT00797277|O2|Outcome|2. IM Haloperidol Pus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
333060|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
333061|NCT00797277|O2|Outcome|2. IM Haloperidol Plus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
333062|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
333063|NCT00797277|E2|Reported Event|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
333064|NCT00797277|E1|Reported Event|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
333065|NCT00797212|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
333066|NCT00797212|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
333067|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
333068|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
333069|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
333070|NCT00797212|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
333071|NCT00797108|B4|Baseline|Total|Total of all reporting groups
333072|NCT00797108|B3|Baseline|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333073|NCT00797108|B2|Baseline|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333074|NCT00797108|B1|Baseline|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
334091|NCT00795184|O3|Outcome|pCLE|
333075|NCT00797108|P3|Participant Flow|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333076|NCT00797108|P2|Participant Flow|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333077|NCT00797108|P1|Participant Flow|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333078|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333079|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333080|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333081|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333082|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333083|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333084|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333139|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
334092|NCT00795184|O2|Outcome|NBI (Narrow Band Imaging)|
333085|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333086|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333087|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333088|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333089|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333090|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333091|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333092|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333093|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333094|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333151|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333256|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
333095|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333096|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333097|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333098|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333099|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333100|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333101|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333102|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333103|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333104|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333163|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
334093|NCT00795184|O1|Outcome|HDWLE|
333105|NCT00797108|E3|Reported Event|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333106|NCT00797108|E2|Reported Event|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333107|NCT00797108|E1|Reported Event|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
333108|NCT00796991|B4|Baseline|Total|Total of all reporting groups
333109|NCT00796991|B3|Baseline|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333110|NCT00796991|B2|Baseline|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333111|NCT00796991|B1|Baseline|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333112|NCT00796991|P3|Participant Flow|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333113|NCT00796991|P2|Participant Flow|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333114|NCT00796991|P1|Participant Flow|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333115|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333116|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333257|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
333258|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
333259|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
333260|NCT00796744|E3|Reported Event|0.01% DSC127|0.01% DSC127 in Vehicle Control
333117|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333118|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333119|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333120|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333121|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333122|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333123|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333124|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333125|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333126|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333127|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333175|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333261|NCT00796744|E2|Reported Event|0.03 % DSC127|0.03% DSC127 in Vehicle Control
333128|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333129|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333130|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333131|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333132|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333133|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333134|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333135|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333136|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333137|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333138|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333262|NCT00796744|E1|Reported Event|Placebo Vehicle Control|control placebo vehicle
333312|NCT00796705|E1|Reported Event|Non-Switcher/Adalimumab|Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab
333140|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333141|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333142|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333143|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333144|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333145|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333146|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333147|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333148|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333149|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333150|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333263|NCT00796718|B1|Baseline|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333152|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333153|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333154|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333155|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333156|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333157|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333158|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333159|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333160|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333161|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333162|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333264|NCT00796718|P1|Participant Flow|Capecitabine|Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333164|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333165|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333166|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333167|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333168|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333169|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333170|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333171|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333172|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333173|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333174|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333265|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333176|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333177|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333178|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333179|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333180|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333181|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333182|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333183|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333184|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333185|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333186|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333266|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333187|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333188|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333189|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333190|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333191|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333192|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333193|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333194|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333195|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333196|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333197|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333240|NCT00796757|E1|Reported Event|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333241|NCT00796744|B4|Baseline|Total|Total of all reporting groups
333242|NCT00796744|B3|Baseline|0.01% DSC127|0.01% DSC127 in Vehicle Control
333243|NCT00796744|B2|Baseline|0.03 % DSC127|0.03% DSC127 in Vehicle Control
333313|NCT00796666|B3|Baseline|Total|Total of all reporting groups
333198|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333199|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333200|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333201|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333202|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333203|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333204|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333205|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333206|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333207|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333208|NCT00796991|E3|Reported Event|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333244|NCT00796744|B1|Baseline|Placebo Vehicle Control|control placebo vehicle
333245|NCT00796744|P3|Participant Flow|0.01% DSC127|0.01% DSC127 in Vehicle Control
333246|NCT00796744|P2|Participant Flow|0.03 % DSC127|0.03% DSC127 in Vehicle Control
333247|NCT00796744|P1|Participant Flow|Placebo Vehicle Control|control placebo vehicle
333248|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
333209|NCT00796991|E2|Reported Event|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333210|NCT00796991|E1|Reported Event|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
333211|NCT00796926|B3|Baseline|Total|Total of all reporting groups
333212|NCT00796926|B2|Baseline|Refresh|Four times a day for 6 weeks in each eye
333213|NCT00796926|B1|Baseline|Systane Ultra|four times a day for six weeks in each eye
333214|NCT00796926|P2|Participant Flow|Refresh|Four times a day for 6 weeks in each eye
333215|NCT00796926|P1|Participant Flow|Systane Ultra|four times a day for six weeks in each eye
333216|NCT00796926|O2|Outcome|Refresh|Four times a day for 6 weeks in each eye
333217|NCT00796926|O1|Outcome|Systane Ultra|four times a day for six weeks in each eye
333218|NCT00796926|E2|Reported Event|Refresh|Four times a day for 6 weeks in each eye
333219|NCT00796926|E1|Reported Event|Systane Ultra|four times a day for six weeks in each eye
333220|NCT00796822|B3|Baseline|Total|Total of all reporting groups
333221|NCT00796822|B2|Baseline|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
333222|NCT00796822|B1|Baseline|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
333223|NCT00796822|P2|Participant Flow|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
333224|NCT00796822|P1|Participant Flow|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
333225|NCT00796822|O2|Outcome|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
333226|NCT00796822|O1|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
333227|NCT00796822|E2|Reported Event|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
333228|NCT00796822|E1|Reported Event|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
333229|NCT00796757|B1|Baseline|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333230|NCT00796757|P1|Participant Flow|Bevacizumab Plus (+) Interferon|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333231|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333232|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333233|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333234|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333235|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333236|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333237|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333238|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333239|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
333249|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
333250|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
333267|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333268|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333269|NCT00796718|E1|Reported Event|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
333270|NCT00796705|B5|Baseline|Total|Total of all reporting groups
333271|NCT00796705|B4|Baseline|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333272|NCT00796705|B3|Baseline|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333273|NCT00796705|B2|Baseline|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333274|NCT00796705|B1|Baseline|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333275|NCT00796705|P4|Participant Flow|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333276|NCT00796705|P3|Participant Flow|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333277|NCT00796705|P2|Participant Flow|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333278|NCT00796705|P1|Participant Flow|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333279|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333280|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333281|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333282|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333311|NCT00796705|E2|Reported Event|Non-Switcher/Etanercept|Subjects failing Etanercept at screening who were randomized to remain on Etanercept
333702|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333283|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333284|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333285|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333286|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333287|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333288|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333289|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333290|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333291|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333292|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333293|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333294|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333295|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333296|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333899|NCT00795600|B3|Baseline|Total|Total of all reporting groups
333297|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333298|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333299|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333300|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333301|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333302|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333303|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333304|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333305|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333306|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
333307|NCT00796705|O2|Outcome|Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333308|NCT00796705|O1|Outcome|Non-Switcher/ Adalimumab or Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
333309|NCT00796705|E4|Reported Event|Switcher/Etanercept to Adalimumab|Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
333310|NCT00796705|E3|Reported Event|Switcher/Adalimumab to Etanercept|Subjects failing Adalimumab at screening who were randomized to switch to Etanercept
333314|NCT00796666|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333315|NCT00796666|B1|Baseline|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333316|NCT00796666|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333317|NCT00796666|P1|Participant Flow|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333318|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333319|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333320|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333321|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333322|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333323|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333324|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333325|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333326|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333327|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333328|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333329|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333330|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333331|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333332|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333333|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333334|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333335|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333336|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333337|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333338|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333339|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333340|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333341|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333342|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333343|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333344|NCT00796666|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
333345|NCT00796666|E1|Reported Event|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
333346|NCT00796653|B5|Baseline|Total|Total of all reporting groups
333347|NCT00796653|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333348|NCT00796653|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333349|NCT00796653|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333350|NCT00796653|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333351|NCT00796653|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333352|NCT00796653|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333353|NCT00796653|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333354|NCT00796653|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333355|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333356|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333357|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333358|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333359|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333360|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333361|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333362|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333363|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333364|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333365|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333366|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333367|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333368|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333369|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333370|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333371|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333372|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333373|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333374|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333375|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333376|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333377|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333378|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333379|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
333380|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
333381|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333382|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333383|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333384|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333385|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
333386|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
333387|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
333388|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
333389|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333390|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333391|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333392|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333393|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
333394|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
333395|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
333396|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
333397|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333398|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333399|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
333400|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
333401|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
333402|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
333403|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333404|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333405|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333406|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333407|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333408|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333409|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333410|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333411|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333412|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333413|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333414|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333415|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333416|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333417|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333418|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333419|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333420|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333421|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333422|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333423|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333424|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333425|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333426|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333427|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333428|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333429|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333430|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333431|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333432|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333433|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333434|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333435|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333436|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333437|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333438|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333439|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333440|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333441|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333442|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333443|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333444|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333445|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333446|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333447|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333448|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333449|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333450|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333451|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333452|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333453|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333454|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333455|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333456|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333457|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333458|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333459|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333460|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333461|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333462|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333463|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333464|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333465|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333466|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333467|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333468|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333469|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333470|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333471|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333472|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333473|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333474|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333475|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333476|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333477|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333478|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333479|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333480|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333481|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333482|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333483|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333484|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333485|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333486|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333487|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333488|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333489|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333490|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333491|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333492|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333493|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333494|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333495|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333496|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333497|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333498|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333499|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333500|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333501|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333502|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333503|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333504|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333505|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333506|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333507|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333508|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333509|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333510|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333511|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333512|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333513|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333514|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333515|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333516|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333517|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333518|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333519|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333520|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333521|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333522|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333523|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333524|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333525|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333526|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333527|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333528|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333529|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333530|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333531|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333532|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333533|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333534|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333535|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333536|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333537|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333538|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333539|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333540|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333541|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333542|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333543|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333544|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333545|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333546|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333547|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333548|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333549|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333550|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333551|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333552|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333553|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333554|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333555|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333556|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333557|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333558|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333559|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333560|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333561|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333562|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333563|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333564|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333565|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333566|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333567|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333568|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333569|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333570|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333571|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333572|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333573|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333574|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333575|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333576|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333577|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333578|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333579|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333580|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333581|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333582|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333583|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333584|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333585|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333586|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333587|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333588|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333589|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333590|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333591|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333592|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333593|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333594|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333595|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333596|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333597|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333598|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333599|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333600|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333601|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333602|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333603|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333604|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333605|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333606|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333607|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333608|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333609|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333610|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333611|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333612|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333613|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333614|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333615|NCT00796653|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
333616|NCT00796653|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
333617|NCT00796653|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
333618|NCT00796653|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
333619|NCT00796614|B5|Baseline|Total|Total of all reporting groups
333620|NCT00796614|B4|Baseline|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333621|NCT00796614|B3|Baseline|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333622|NCT00796614|B2|Baseline|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333623|NCT00796614|B1|Baseline|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333624|NCT00796614|P4|Participant Flow|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333625|NCT00796614|P3|Participant Flow|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333626|NCT00796614|P2|Participant Flow|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333627|NCT00796614|P1|Participant Flow|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333628|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333629|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333697|NCT00796510|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
333698|NCT00796510|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333630|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333631|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333632|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333633|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333634|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333635|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333636|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333637|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333638|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333639|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333640|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333641|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333642|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333643|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333644|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333645|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333646|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333699|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
334094|NCT00795184|E1|Reported Event|Group 1|NBI-pCLE or pCLE-NBI
333647|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333648|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333649|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333650|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333651|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333652|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333653|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333654|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333655|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333656|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333657|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333658|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333659|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333660|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333661|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333662|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333663|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333700|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333701|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
333664|NCT00796614|E4|Reported Event|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333665|NCT00796614|E3|Reported Event|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333666|NCT00796614|E2|Reported Event|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333667|NCT00796614|E1|Reported Event|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
333668|NCT00796549|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333669|NCT00796549|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333670|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333671|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333672|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333673|NCT00796549|O2|Outcome|Afatinib 50mg 2nd Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
333674|NCT00796549|O1|Outcome|Afatinib 50mg 1st Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.
333675|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333676|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333677|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333678|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333679|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333680|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333681|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
333682|NCT00796549|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
333683|NCT00796523|B3|Baseline|Total|Total of all reporting groups
333684|NCT00796523|B2|Baseline|Control Videotape|videotape with normal newborn instruction
333685|NCT00796523|B1|Baseline|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
333686|NCT00796523|P2|Participant Flow|Control Videotape|videotape with normal newborn instruction
333687|NCT00796523|P1|Participant Flow|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
333688|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
333689|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
333690|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
333691|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
333692|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
333693|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
333694|NCT00796510|B3|Baseline|Total|Total of all reporting groups
333695|NCT00796510|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
333696|NCT00796510|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333703|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
333704|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333705|NCT00796510|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
333706|NCT00796510|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
333707|NCT00796367|B4|Baseline|Total|Total of all reporting groups
333708|NCT00796367|B3|Baseline|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
333709|NCT00796367|B2|Baseline|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
333710|NCT00796367|B1|Baseline|Placebo|Placebo
333711|NCT00796367|P3|Participant Flow|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
333712|NCT00796367|P2|Participant Flow|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
333713|NCT00796367|P1|Participant Flow|Placebo|Placebo
333714|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
333715|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
333716|NCT00796367|O1|Outcome|Placebo|Placebo
333717|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
333718|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
333719|NCT00796367|O1|Outcome|Placebo|Placebo
333720|NCT00796367|E3|Reported Event|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
333721|NCT00796367|E2|Reported Event|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
333722|NCT00796367|E1|Reported Event|Placebo|Placebo
333723|NCT00796328|B1|Baseline|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
333724|NCT00796328|P1|Participant Flow|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
333725|NCT00796328|O1|Outcome|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
333726|NCT00796328|E1|Reported Event|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
333727|NCT00796315|B1|Baseline|Doxylamine Succinate USP|Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
333728|NCT00796315|P3|Participant Flow|Subjects Aged 12-17 Years (Doxylamine Suc|Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
333729|NCT00796315|P2|Participant Flow|Aged 6-11 Years (Doxylamine Succinate|"Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.~Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued."
333730|NCT00796315|P1|Participant Flow|Subjects Aged 2-5 Years (Doxylamine Succinate)|Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
333731|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine Succinate USP
333732|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
333733|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
333734|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
333735|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
333736|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
333737|NCT00796315|E3|Reported Event|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine succinate USP
333738|NCT00796315|E2|Reported Event|Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
333739|NCT00796315|E1|Reported Event|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
333740|NCT00796302|B3|Baseline|Total|Total of all reporting groups
333741|NCT00796302|B2|Baseline|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
333742|NCT00796302|B1|Baseline|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333743|NCT00796302|P2|Participant Flow|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
333744|NCT00796302|P1|Participant Flow|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333745|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
333746|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333747|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
333748|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333749|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
333750|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333751|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and risperidone. Parents will receive parent management training
333752|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333753|NCT00796302|E2|Reported Event|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
334095|NCT00795145|B3|Baseline|Total|Total of all reporting groups
333754|NCT00796302|E1|Reported Event|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
333755|NCT00796224|B3|Baseline|Total|Total of all reporting groups
333756|NCT00796224|B2|Baseline|30 mg/kg Azithromycin IR|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
333757|NCT00796224|B1|Baseline|60 mg/kg Azithromycin ER|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
333758|NCT00796224|P2|Participant Flow|30 mg/kg Azithromycin Immediate-release (IR)|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
333759|NCT00796224|P1|Participant Flow|60 mg/kg Azithromycin Extended-release (ER)|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
333760|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333761|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333762|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333763|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333764|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR (Reference)|
333765|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER (Test)|
333766|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333767|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333768|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333769|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333770|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333771|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333772|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
333773|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
333774|NCT00796224|E2|Reported Event|30 mg/kg Azithromycin IR|
333775|NCT00796224|E1|Reported Event|60 mg/kg Azithromycin ER|
333776|NCT00796120|B3|Baseline|Total|Total of all reporting groups
333777|NCT00796120|B2|Baseline|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333778|NCT00796120|B1|Baseline|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333779|NCT00796120|P2|Participant Flow|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333780|NCT00796120|P1|Participant Flow|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333781|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333782|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333783|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333784|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333785|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333786|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333787|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333788|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333789|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333790|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333791|NCT00796120|E2|Reported Event|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
333792|NCT00796120|E1|Reported Event|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
333793|NCT00796003|B3|Baseline|Total|Total of all reporting groups
333794|NCT00796003|B2|Baseline|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
333795|NCT00796003|B1|Baseline|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333796|NCT00796003|P2|Participant Flow|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
334084|NCT00795210|E1|Reported Event|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
333797|NCT00796003|P1|Participant Flow|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333798|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333799|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333800|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333801|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333802|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333803|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333804|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333805|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333806|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333807|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333808|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333809|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333810|NCT00796003|O3|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333811|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333812|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
333813|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333814|NCT00796003|E3|Reported Event|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
333815|NCT00796003|E2|Reported Event|Phase I - 20 mg/m2 Group|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
333816|NCT00796003|E1|Reported Event|Phase I - 15 mg/m2 Group|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
333817|NCT00795951|B1|Baseline|Single Arm Study|All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
333818|NCT00795951|P1|Participant Flow|Diagnostic Performance: Nickel Sulfate|Number of subjects with reactions recorded at visit 3 or 4
333819|NCT00795951|O1|Outcome|Itching|Number of subjects who presented with itching at patch removal
333820|NCT00795951|O1|Outcome|Adhesion|Number of subjects who presented with poor adhesion at patch removal
333821|NCT00795951|O1|Outcome|Irritation|Number of subjects who presented with irritation at patch removal
333822|NCT00795951|O1|Outcome|Persistent Reactions|Number of subjects who presented with persistent reactions
333823|NCT00795951|O1|Outcome|Late Reactions|Number of subjects who presented with late reactions
333824|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333825|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333826|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333827|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333828|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333829|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333830|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333831|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333832|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333833|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333834|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333835|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333836|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333837|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333838|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333839|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333840|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
334085|NCT00795184|B1|Baseline|Group 1|NBI-pCLE
333841|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333842|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333843|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333844|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333845|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333846|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333847|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333848|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333849|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333850|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333851|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
333852|NCT00795951|O1|Outcome|Diagnostic Performance: Nickel Sulfate|Number of subjects with a positive reaction to nickel sulfate at visit 3 or visit 4
333853|NCT00795951|E1|Reported Event|Safety|Adverse Events
333854|NCT00795886|B1|Baseline|Rapamycin|This includes all study participants.
333855|NCT00795886|P1|Participant Flow|Rapamycin|This includes all study participants.
333856|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
333857|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
333858|NCT00795886|O1|Outcome|Rate of Transplant Related Mortality|All participants enrolled in the trial
333859|NCT00795886|E1|Reported Event|Rapamycin|This includes all study participants.
333860|NCT00795717|B3|Baseline|Total|Total of all reporting groups
333861|NCT00795717|B2|Baseline|Placebo Then Lovaza|"Placebo or Corn oil pill, dietary counseling~Corn oil pill : 2 capsules given twice daily for 12 weeks"
333862|NCT00795717|B1|Baseline|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
333863|NCT00795717|P2|Participant Flow|Placebo Then Lovaza|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks"
333864|NCT00795717|P1|Participant Flow|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily."
333865|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
333866|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
333867|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
333868|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
333869|NCT00795717|O2|Outcome|Placebo|"Corn oil, dietary counseling~Corn oil : 2 capsules given twice daily"
333870|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
333871|NCT00795717|E2|Reported Event|Placebo|Placebo, dietary counseling
333872|NCT00795717|E1|Reported Event|Lovaza-Active|Lovaza, dietary counseling
333873|NCT00795704|B3|Baseline|Total|Total of all reporting groups
333874|NCT00795704|B2|Baseline|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333875|NCT00795704|B1|Baseline|Placebo|Control Group
333876|NCT00795704|P2|Participant Flow|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333877|NCT00795704|P1|Participant Flow|Placebo|Control Group
333878|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333879|NCT00795704|O1|Outcome|Placebo|Control Group
333880|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333881|NCT00795704|O1|Outcome|Placebo|Control Group
333882|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333883|NCT00795704|O1|Outcome|Placebo|Control Group
333884|NCT00795704|E2|Reported Event|Mulberry Leaf Extract|500 mg #2 capsules three times daily
333885|NCT00795704|E1|Reported Event|Placebo|Control Group
333886|NCT00795639|B3|Baseline|Total|Total of all reporting groups
333887|NCT00795639|B2|Baseline|Placebo|Matching placebo tablet once a day
333888|NCT00795639|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333889|NCT00795639|P2|Participant Flow|Placebo|Matching placebo tablet once a day
333890|NCT00795639|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333891|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
333892|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333893|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
333894|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333895|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
333896|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333897|NCT00795639|E2|Reported Event|Placebo|Matching placebo tablet once a day
333898|NCT00795639|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
333900|NCT00795600|B2|Baseline|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333901|NCT00795600|B1|Baseline|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333902|NCT00795600|P2|Participant Flow|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333903|NCT00795600|P1|Participant Flow|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333904|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333905|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333906|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333907|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333908|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333909|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333910|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333911|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333912|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333913|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333914|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333915|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333916|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333917|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333918|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333919|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333920|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333921|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333922|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333923|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333924|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333925|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333926|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333927|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333928|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333929|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333930|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333931|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333932|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333933|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334086|NCT00795184|P2|Participant Flow|NBI First HDWLE Second and pCLE|
333934|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333935|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333936|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333937|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333938|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333939|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333940|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333941|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333942|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333943|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333944|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333945|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333946|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333947|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333948|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333949|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333950|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333951|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333952|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333953|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333954|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333955|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333956|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333957|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333958|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333959|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333960|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333961|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333962|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333963|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333964|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333965|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333966|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333967|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334087|NCT00795184|P1|Participant Flow|HDWLE First NBI Second and pCLE|
333968|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333969|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333970|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333971|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333972|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333973|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333974|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333975|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333976|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333977|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333978|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333979|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333980|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333981|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333982|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333983|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333984|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333985|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333986|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333987|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333988|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333989|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333990|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333991|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333992|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333993|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333994|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333995|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333996|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333997|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333998|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
333999|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334000|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334001|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334088|NCT00795184|O6|Outcome|HDWLE+NBI|
334089|NCT00795184|O5|Outcome|HDWLE+pCLE|
334002|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334003|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334004|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334005|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334006|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334007|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334008|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334009|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334010|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334011|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334012|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334013|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334014|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334015|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334016|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334017|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334018|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334019|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334020|NCT00795600|E2|Reported Event|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334021|NCT00795600|E1|Reported Event|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
334022|NCT00795535|B1|Baseline|Trauma Patients|Patients transported to the trauma center by helicopter
334023|NCT00795535|P1|Participant Flow|Trauma Patients|Patients transported to the trauma center by helicopter
334024|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
334025|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
334026|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
334027|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
334028|NCT00795535|E1|Reported Event|Trauma Patients|Patients transported to the trauma center by helicopter
334029|NCT00795509|B1|Baseline|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
334030|NCT00795509|P1|Participant Flow|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
334031|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
334032|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
334033|NCT00795509|E1|Reported Event|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
334034|NCT00795366|B3|Baseline|Total|Total of all reporting groups
334035|NCT00795366|B2|Baseline|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
334036|NCT00795366|B1|Baseline|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
334037|NCT00795366|P2|Participant Flow|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
334038|NCT00795366|P1|Participant Flow|AVP, Arginine Vasopressin|Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
334039|NCT00795366|O2|Outcome|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
334040|NCT00795366|O1|Outcome|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
334041|NCT00795366|E2|Reported Event|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
334042|NCT00795366|E1|Reported Event|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
334043|NCT00795340|B3|Baseline|Total|Total of all reporting groups
334044|NCT00795340|B2|Baseline|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
334045|NCT00795340|B1|Baseline|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
334046|NCT00795340|P2|Participant Flow|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
334047|NCT00795340|P1|Participant Flow|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
334048|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
334049|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
334050|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
334051|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
334052|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
334053|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
334054|NCT00795340|E2|Reported Event|Placebo|Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
334055|NCT00795340|E1|Reported Event|Cediranib|Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
334056|NCT00795288|B3|Baseline|Total|Total of all reporting groups
334057|NCT00795288|B2|Baseline|Control|placebo: Control group
334058|NCT00795288|B1|Baseline|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
334059|NCT00795288|P2|Participant Flow|Simvastatin|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334060|NCT00795288|P1|Participant Flow|Placebo|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334061|NCT00795288|O2|Outcome|Placebo|"Placebo~placebo: Control group"
334062|NCT00795288|O1|Outcome|Simvastatin, 80 mg/Day|"Simvastatin, 80 mg/day for 21 days~Simvastatin, 80 mg/day for 21 days: Active treatment group"
334063|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334064|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334065|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334066|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
334067|NCT00795288|E2|Reported Event|Control|placebo: Control group
334068|NCT00795288|E1|Reported Event|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
334069|NCT00795210|B4|Baseline|Total|Total of all reporting groups
334070|NCT00795210|B3|Baseline|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
334071|NCT00795210|B2|Baseline|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
334072|NCT00795210|B1|Baseline|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
334073|NCT00795210|P3|Participant Flow|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
334074|NCT00795210|P2|Participant Flow|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
334075|NCT00795210|P1|Participant Flow|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
334076|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
334077|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
334078|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
334079|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
334080|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
334081|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
334082|NCT00795210|E3|Reported Event|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
334083|NCT00795210|E2|Reported Event|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
334096|NCT00795145|B2|Baseline|Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin|Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose.
334097|NCT00795145|B1|Baseline|Cohort 1: Placebo, Linezolid 900 mg and 1200 mg|Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses.
334098|NCT00795145|P7|Participant Flow|Cohort 2: Sequence 4|Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4.
334099|NCT00795145|P6|Participant Flow|Cohort 2: Sequence 3|Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3.
334100|NCT00795145|P5|Participant Flow|Cohort 2: Sequence 2|Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2.
334101|NCT00795145|P4|Participant Flow|Cohort 2: Sequence 1|Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1.
334102|NCT00795145|P3|Participant Flow|Cohort 1: Sequence 3|Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3.
334103|NCT00795145|P2|Participant Flow|Cohort 1: Sequence 2|Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2.
334104|NCT00795145|P1|Participant Flow|Cohort 1: Sequence 1|Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1.
334105|NCT00795145|O4|Outcome|Moxifloxacin 400 mg|
334106|NCT00795145|O3|Outcome|Cohort 2: Placebo|
334107|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334108|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
334109|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334110|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
334111|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334112|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
334113|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334114|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
334115|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334116|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
334117|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
334118|NCT00795145|O1|Outcome|Cohort 2: 900 mg Linezolid|
334119|NCT00795145|O3|Outcome|Cohort 2: 1200 mg Linezolid|
334120|NCT00795145|O2|Outcome|Cohort 2: 600 mg Linezolid|
334121|NCT00795145|O1|Outcome|Cohort 2: Placebo|
334122|NCT00795145|O2|Outcome|Cohort 2: Placebo|
334123|NCT00795145|O1|Outcome|Cohort 2: Moxifloxacin|Oral administration, positive control, not blinded.
334124|NCT00795145|O3|Outcome|Cohort 2: Placebo|0.9% Saline
334125|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|Zyvox IV Injection
334126|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|Zyvox IV Injection
334127|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
334128|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
334129|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
334130|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
334131|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
334132|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
334133|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
334134|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
334135|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
334136|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
334137|NCT00795145|O3|Outcome|Cohort 1: 1200 mg Linezolid|600 mL Zyvox as a constant rate IV infusion of 60 minutes.
334138|NCT00795145|O2|Outcome|Cohort 1: 900 mg Linezolid|450 mL Zyvox plus 150 mL saline as a constant rate IV infusion of 60 minutes.
334139|NCT00795145|O1|Outcome|Cohort 1: Placebo|600 milliliters (mL) saline as a constant rate intravenous (IV) infusion of 60 minutes.
334140|NCT00795145|E7|Reported Event|Cohort 2: 400 mg Moxifloxacin|
334141|NCT00795145|E6|Reported Event|Cohort 2: 1200 mg Linezolid|
334142|NCT00795145|E5|Reported Event|Cohort 2: 600 mg Linezolid|
334143|NCT00795145|E4|Reported Event|Cohort 2: Placebo|
334144|NCT00795145|E3|Reported Event|Cohort 1: 1200 mg Linezolid|
334145|NCT00795145|E2|Reported Event|Cohort 1: 900 mg Linezolid|
334146|NCT00795145|E1|Reported Event|Cohort 1: Placebo|
334147|NCT00795132|B1|Baseline|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
334148|NCT00795132|P1|Participant Flow|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
334149|NCT00795132|O3|Outcome|Unrelated Cord Blood|All incidences of enrolled patients were analyzed.
334150|NCT00795132|O2|Outcome|Unrelated BM PBSC|All incidences of enrolled patients were analyzed.
334151|NCT00795132|O1|Outcome|Related BM PBSC|All incidences of enrolled patients were analyzed.
334152|NCT00795132|O3|Outcome|Unrelated Cord Blood|All participants were analyzed.
334153|NCT00795132|O2|Outcome|Unrelated BM PBSC|All participants were analyzed.
334154|NCT00795132|O1|Outcome|Related BM PBSC|All participants were analyzed.
334155|NCT00795132|O3|Outcome|Unrelated Cord Blood|Unrelated donor: Cord Blood
334156|NCT00795132|O2|Outcome|Unrelated BM PBSC|Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
334157|NCT00795132|O1|Outcome|Related BM PBSC|Related donor: bone marrow or peripheral blood stem cell (PBSC)
334158|NCT00795132|E1|Reported Event|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
334159|NCT00795002|B3|Baseline|Total|Total of all reporting groups
334160|NCT00795002|B2|Baseline|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
334161|NCT00795002|B1|Baseline|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
334162|NCT00795002|P2|Participant Flow|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
334163|NCT00795002|P1|Participant Flow|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
334164|NCT00795002|O2|Outcome|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
334165|NCT00795002|O1|Outcome|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
334166|NCT00795002|E2|Reported Event|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
334167|NCT00795002|E1|Reported Event|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
334168|NCT00794963|B3|Baseline|Total|Total of all reporting groups
334169|NCT00794963|B2|Baseline|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
334170|NCT00794963|B1|Baseline|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
334171|NCT00794963|P2|Participant Flow|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
334172|NCT00794963|P1|Participant Flow|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
334173|NCT00794963|O2|Outcome|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
334174|NCT00794963|O1|Outcome|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
334175|NCT00794963|E2|Reported Event|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
334176|NCT00794963|E1|Reported Event|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
334177|NCT00794924|B3|Baseline|Total|Total of all reporting groups
334178|NCT00794924|B2|Baseline|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
334179|NCT00794924|B1|Baseline|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
334180|NCT00794924|P2|Participant Flow|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
334181|NCT00794924|P1|Participant Flow|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
334182|NCT00794924|O2|Outcome|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
334183|NCT00794924|O1|Outcome|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
334184|NCT00794820|B1|Baseline|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334185|NCT00794820|P1|Participant Flow|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334186|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334187|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334188|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334189|NCT00794820|E1|Reported Event|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
334190|NCT00794677|B3|Baseline|Total|Total of all reporting groups
334191|NCT00794677|B2|Baseline|Placebo|Placebo once daily received as the first or second intervention
334192|NCT00794677|B1|Baseline|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334193|NCT00794677|P2|Participant Flow|Placebo|Placebo once daily received as the first or second intervention
334194|NCT00794677|P1|Participant Flow|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334195|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334196|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334197|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334198|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334199|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334200|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334201|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334202|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334203|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334204|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334205|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334206|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334207|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334208|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334209|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334210|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334211|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
334212|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
334213|NCT00794664|B3|Baseline|Total|Total of all reporting groups
334214|NCT00794664|B2|Baseline|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334215|NCT00794664|B1|Baseline|Placebo|Weekly subcutaneous injections for 26 weeks
334216|NCT00794664|P2|Participant Flow|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334217|NCT00794664|P1|Participant Flow|Placebo|Weekly subcutaneous injections for 26 weeks
334218|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334219|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334220|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334221|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334222|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334223|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334224|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334225|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334226|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334227|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334228|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334229|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334230|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334231|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334232|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334233|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334234|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334235|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334236|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334237|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334238|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334239|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334240|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334241|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334242|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334243|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334244|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334245|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334246|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334247|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334248|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334249|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334250|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334251|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334252|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334253|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334254|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334255|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334256|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334257|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
334258|NCT00794664|E2|Reported Event|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
334259|NCT00794664|E1|Reported Event|Placebo|Weekly subcutaneous injections for 26 weeks
334260|NCT00794560|B5|Baseline|Total|Total of all reporting groups
334261|NCT00794560|B4|Baseline|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
334262|NCT00794560|B3|Baseline|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334263|NCT00794560|B2|Baseline|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
334264|NCT00794560|B1|Baseline|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334265|NCT00794560|P4|Participant Flow|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
334266|NCT00794560|P3|Participant Flow|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334267|NCT00794560|P2|Participant Flow|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
334268|NCT00794560|P1|Participant Flow|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334269|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
334270|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334271|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
334272|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334273|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
334274|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334275|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
334300|NCT00794365|B1|Baseline|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334301|NCT00794365|P1|Participant Flow|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334454|NCT00793793|B13|Baseline|Total|Total of all reporting groups
334276|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334277|NCT00794560|E4|Reported Event|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
334278|NCT00794560|E3|Reported Event|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334279|NCT00794560|E2|Reported Event|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
334280|NCT00794560|E1|Reported Event|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
334281|NCT00794547|B1|Baseline|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334282|NCT00794547|P2|Participant Flow|Phase 2|"In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.~Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy"
334283|NCT00794547|P1|Participant Flow|Phase 1|"In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.~Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days."
334284|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334285|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334286|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334287|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334288|NCT00794547|E1|Reported Event|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
334289|NCT00794508|B1|Baseline|Experimental Retroviral-mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
334290|NCT00794508|P1|Participant Flow|Gamma-retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the gamma-retroviral vector, MND-ADA, carrying the human ADA gene."
334291|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
334292|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
334293|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
334294|NCT00794508|E1|Reported Event|Retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene."
334295|NCT00794469|B1|Baseline|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
334296|NCT00794469|P1|Participant Flow|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
334297|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
334298|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
334299|NCT00794469|E1|Reported Event|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
335754|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
334302|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334303|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334304|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334305|NCT00794365|E1|Reported Event|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
334306|NCT00794196|B3|Baseline|Total|Total of all reporting groups
334307|NCT00794196|B2|Baseline|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
334308|NCT00794196|B1|Baseline|Usual Care|The control group will be receiving usual medical and pharmaceutical care.
334309|NCT00794196|P2|Participant Flow|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
334310|NCT00794196|P1|Participant Flow|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
334311|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
334312|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
334313|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
334314|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
334315|NCT00794196|E2|Reported Event|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
334316|NCT00794196|E1|Reported Event|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
334317|NCT00794170|B3|Baseline|Total|Total of all reporting groups
334318|NCT00794170|B2|Baseline|Usual Care|control
334319|NCT00794170|B1|Baseline|Telephone and Print Based Intervention|This was a tailored phone call followed up by print materials.
334320|NCT00794170|P2|Participant Flow|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
334321|NCT00794170|P1|Participant Flow|Telephone and Print Based Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
334322|NCT00794170|O2|Outcome|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
334323|NCT00794170|O1|Outcome|Telephone and Print Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
334324|NCT00794170|E2|Reported Event|Usual Care|
334325|NCT00794170|E1|Reported Event|Telephone and Print Based Intervention|
334326|NCT00794157|B4|Baseline|Total|Total of all reporting groups
334327|NCT00794157|B3|Baseline|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334377|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334328|NCT00794157|B2|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334329|NCT00794157|B1|Baseline|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334330|NCT00794157|P3|Participant Flow|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334331|NCT00794157|P2|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334332|NCT00794157|P1|Participant Flow|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334333|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334334|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334335|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334336|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334337|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334338|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334339|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334340|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334341|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334342|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334343|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334344|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334345|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334346|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334347|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334348|NCT00794157|E3|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334349|NCT00794157|E2|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334350|NCT00794157|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
334351|NCT00794144|B3|Baseline|Total|Total of all reporting groups
334352|NCT00794144|B2|Baseline|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
334353|NCT00794144|B1|Baseline|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
334354|NCT00794144|P2|Participant Flow|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
334355|NCT00794144|P1|Participant Flow|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
334356|NCT00794144|O2|Outcome|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
334357|NCT00794144|O1|Outcome|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
334358|NCT00794144|E2|Reported Event|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
334359|NCT00794144|E1|Reported Event|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
334360|NCT00794118|B1|Baseline|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334361|NCT00794118|P1|Participant Flow|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334362|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334363|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334364|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334365|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334366|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334367|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334368|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334369|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334370|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334371|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334372|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334373|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334374|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334375|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334376|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334448|NCT00793819|P2|Participant Flow|Placebo|1 placebo capsule daily
334378|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334379|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334380|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334381|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334382|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334383|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334384|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334385|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334386|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334387|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334388|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334389|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334390|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334391|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334392|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334393|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334394|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334395|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334396|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334397|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334398|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334399|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334400|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334401|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334402|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334403|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334404|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334449|NCT00793819|P1|Participant Flow|Silodosin 8mg|Silodosin 8mg daily
334450|NCT00793819|O2|Outcome|Placebo|1 placebo capsule daily
334451|NCT00793819|O1|Outcome|Silodosin 8mg|Silodosin 8mg daily
334405|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334406|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334407|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334408|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334409|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334410|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334411|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334412|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334413|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334414|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334415|NCT00794118|E1|Reported Event|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
334416|NCT00793910|B3|Baseline|Total|Total of all reporting groups
334417|NCT00793910|B2|Baseline|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334418|NCT00793910|B1|Baseline|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334419|NCT00793910|P2|Participant Flow|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334420|NCT00793910|P1|Participant Flow|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334421|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334422|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334423|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334424|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334425|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334426|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334427|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334428|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334429|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334430|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334431|NCT00793910|E2|Reported Event|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
334432|NCT00793910|E1|Reported Event|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
334433|NCT00793871|B1|Baseline|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334434|NCT00793871|P1|Participant Flow|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334435|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334452|NCT00793819|E2|Reported Event|Placebo|1 placebo capsule daily
334453|NCT00793819|E1|Reported Event|Silodosin 8mg|Silodosin 8mg daily
334436|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334437|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334438|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334439|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334440|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334441|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334442|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334443|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334444|NCT00793871|E1|Reported Event|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
334445|NCT00793819|B3|Baseline|Total|Total of all reporting groups
334446|NCT00793819|B2|Baseline|Placebo|1 placebo capsule daily
334447|NCT00793819|B1|Baseline|Silodosin 8mg|Silodosin 8mg daily
334455|NCT00793793|B12|Baseline|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334456|NCT00793793|B11|Baseline|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334457|NCT00793793|B10|Baseline|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334458|NCT00793793|B9|Baseline|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334459|NCT00793793|B8|Baseline|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334460|NCT00793793|B7|Baseline|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334461|NCT00793793|B6|Baseline|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334462|NCT00793793|B5|Baseline|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334463|NCT00793793|B4|Baseline|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334464|NCT00793793|B3|Baseline|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334465|NCT00793793|B2|Baseline|TN: 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334466|NCT00793793|B1|Baseline|Treatment Naive (TN): Placebo|TN patient to receive Placebo + PegIFN/RBV for 28 days
334467|NCT00793793|P12|Participant Flow|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334468|NCT00793793|P11|Participant Flow|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334469|NCT00793793|P10|Participant Flow|TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334470|NCT00793793|P9|Participant Flow|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334471|NCT00793793|P8|Participant Flow|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334472|NCT00793793|P7|Participant Flow|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334473|NCT00793793|P6|Participant Flow|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334474|NCT00793793|P5|Participant Flow|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334475|NCT00793793|P4|Participant Flow|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334476|NCT00793793|P3|Participant Flow|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334477|NCT00793793|P2|Participant Flow|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334478|NCT00793793|P1|Participant Flow|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334479|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334480|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334481|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334482|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334483|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334484|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334485|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334486|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334487|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334488|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334489|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334490|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334491|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334492|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334493|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334494|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334495|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334496|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334497|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334498|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334499|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334500|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334501|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334502|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334503|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334504|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334505|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334506|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334507|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334508|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334509|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334510|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334511|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334512|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334513|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334514|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334515|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334516|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334517|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334518|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334519|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334520|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334521|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334522|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334523|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334524|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334525|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334526|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334527|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334528|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334529|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334530|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334531|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334532|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334533|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334534|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334535|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334536|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334537|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334538|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334539|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334540|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334541|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334542|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334543|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334544|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334545|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334546|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
336387|NCT00790218|O3|Outcome|CF102 25mg|CF102 tablets given orally, BID
334547|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334548|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334549|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334550|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334551|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334552|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334553|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334554|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334555|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334556|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334557|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334558|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334559|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334560|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334561|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334562|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334563|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334564|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334565|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334566|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334567|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334568|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334569|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334570|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334571|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334572|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334573|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334574|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334575|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334576|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334577|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334578|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334579|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334580|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334581|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334582|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334583|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334584|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334585|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334586|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334587|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334588|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334589|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334590|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334591|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334592|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334593|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334594|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334595|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334596|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334597|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334598|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334599|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334600|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334601|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334602|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334603|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334604|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334605|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334606|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334607|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334608|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334609|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334610|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334611|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334612|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334613|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334614|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334615|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334616|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334617|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334618|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334619|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334620|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334621|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334622|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334623|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334624|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334625|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334626|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334627|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334628|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334629|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334630|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334631|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334632|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334633|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334634|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334635|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334636|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334637|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334822|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334638|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334639|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334640|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334641|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334642|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334643|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334644|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334645|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334646|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334647|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334648|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334649|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334650|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334651|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334652|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334653|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334654|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334655|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334656|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334657|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334658|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334659|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334660|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334661|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334662|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334663|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334664|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334665|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334666|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334667|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334668|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334669|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334670|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334671|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334672|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334673|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334674|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334675|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334676|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334677|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334678|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334679|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334680|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334681|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334682|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334683|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334684|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334685|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334686|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334687|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334688|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334689|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334690|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334691|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334692|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334693|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334694|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334695|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334696|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334697|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334698|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334699|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334700|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334701|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334702|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334703|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334704|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334705|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334706|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334707|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334708|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334709|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334710|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334711|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334712|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334713|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334714|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334715|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334716|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334717|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334718|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334719|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334720|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334721|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334722|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334723|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334724|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334725|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334726|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334727|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334728|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334729|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334730|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334731|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334732|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334733|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334734|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334735|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334736|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334737|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334738|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334739|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334740|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334741|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334742|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334743|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334744|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334745|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334746|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334747|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334748|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334749|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334750|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334751|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334752|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334753|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334754|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334755|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334756|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334757|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334758|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334759|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334760|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334761|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334762|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334763|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334764|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334765|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334766|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334767|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334768|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334769|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334770|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334771|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334772|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334773|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334774|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334775|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334776|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334777|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334778|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334779|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334780|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334781|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334782|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334783|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334784|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334785|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334786|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334787|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334788|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334789|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334790|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334791|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334792|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334793|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334794|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334795|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334796|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334797|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334798|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334799|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334800|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334801|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334802|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334803|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334804|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334805|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334806|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334807|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334808|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334809|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334810|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334811|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334812|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334813|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334814|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334815|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334816|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334817|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334818|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334819|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334820|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334821|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334823|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334824|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334825|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334826|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334827|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334828|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334829|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334830|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334831|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334832|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334833|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334834|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334835|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334836|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334837|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
334838|NCT00793793|E12|Reported Event|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334839|NCT00793793|E11|Reported Event|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334840|NCT00793793|E10|Reported Event|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334841|NCT00793793|E9|Reported Event|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
334842|NCT00793793|E8|Reported Event|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334843|NCT00793793|E7|Reported Event|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334844|NCT00793793|E6|Reported Event|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
334845|NCT00793793|E5|Reported Event|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334846|NCT00793793|E4|Reported Event|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334847|NCT00793793|E3|Reported Event|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
334848|NCT00793793|E2|Reported Event|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
334849|NCT00793793|E1|Reported Event|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
334850|NCT00793780|B3|Baseline|Total|Total of all reporting groups
334851|NCT00793780|B2|Baseline|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334852|NCT00793780|B1|Baseline|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334853|NCT00793780|P2|Participant Flow|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334854|NCT00793780|P1|Participant Flow|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334855|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334856|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334857|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334858|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334859|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334860|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334861|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334862|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334863|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334864|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334865|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334866|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334867|NCT00793780|E2|Reported Event|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
334868|NCT00793780|E1|Reported Event|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
334869|NCT00793650|B3|Baseline|Total|Total of all reporting groups
334870|NCT00793650|B2|Baseline|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
335755|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
334871|NCT00793650|B1|Baseline|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334872|NCT00793650|P2|Participant Flow|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334873|NCT00793650|P1|Participant Flow|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334874|NCT00793650|O2|Outcome|Bortezomib After Melphalan|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334875|NCT00793650|O1|Outcome|Bortezomib Before Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334876|NCT00793650|O2|Outcome|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334877|NCT00793650|O1|Outcome|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334878|NCT00793650|E2|Reported Event|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334879|NCT00793650|E1|Reported Event|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
334880|NCT00793624|B5|Baseline|Total|Total of all reporting groups
334881|NCT00793624|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334882|NCT00793624|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334883|NCT00793624|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334884|NCT00793624|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334885|NCT00793624|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334886|NCT00793624|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334887|NCT00793624|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334888|NCT00793624|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334889|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334890|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334891|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334892|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334893|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334894|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334895|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334896|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334897|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334898|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334899|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334900|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334901|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334902|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334903|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334904|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334905|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334906|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334907|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334908|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334909|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334910|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334911|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334912|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334913|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
334914|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
334915|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334916|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334917|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334918|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334919|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
334920|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
334921|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
334922|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
334923|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334924|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334925|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334926|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334927|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
334928|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
334929|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
334930|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
334931|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334932|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334933|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
334934|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
334935|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
334936|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
334937|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334938|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334939|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334940|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334941|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334942|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334943|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334944|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334945|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334946|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334947|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334948|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334949|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334950|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334951|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334952|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334953|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334954|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334955|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334956|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334957|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334958|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334959|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334960|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334961|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334962|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334963|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334964|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334965|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334966|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334967|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334968|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334969|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334970|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334971|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334972|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334973|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334974|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334975|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334976|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334977|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334978|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334979|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334980|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334981|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334982|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334983|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334984|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334985|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334986|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334987|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334988|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334989|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334990|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334991|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334992|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334993|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334994|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334995|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
334996|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
334997|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
334998|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
334999|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335000|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335001|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335002|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335003|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335004|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335005|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335006|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335007|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335008|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335009|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335010|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335011|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335012|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335013|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335014|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335015|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335016|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335017|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335018|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335019|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335020|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335021|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335022|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335023|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335024|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335025|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335026|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335027|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335028|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335029|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335030|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335031|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335032|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335033|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335034|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335035|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335036|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335037|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335038|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335039|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335040|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335041|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335042|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335043|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335044|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335045|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335046|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335047|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335048|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335049|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335050|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335051|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335052|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335053|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335054|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335055|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335056|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335057|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335058|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335059|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335060|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335061|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335062|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335063|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335064|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335065|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335066|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335067|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335068|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335069|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335070|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335071|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335072|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335073|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335074|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335075|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335076|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335077|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335078|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335079|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335080|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335081|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335082|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335083|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335084|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335085|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335086|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335087|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335088|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335089|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335090|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335091|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335092|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335093|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335094|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335095|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335096|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335097|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335098|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335099|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335100|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335101|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335102|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335103|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335104|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335105|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335106|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335107|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335108|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335109|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335110|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335111|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335112|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335113|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335114|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335115|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335116|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335117|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335118|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335119|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335120|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335121|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335122|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335123|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335124|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335125|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335126|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335127|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335128|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335129|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335130|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335131|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335132|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335133|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335134|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335135|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335136|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335137|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335138|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335139|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335140|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335141|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335142|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335143|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335144|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335145|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335146|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335147|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335148|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335149|NCT00793624|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
335150|NCT00793624|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
335151|NCT00793624|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
335152|NCT00793624|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
335153|NCT00793611|B3|Baseline|Total|Total of all reporting groups
335154|NCT00793611|B2|Baseline|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335155|NCT00793611|B1|Baseline|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335156|NCT00793611|P2|Participant Flow|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335157|NCT00793611|P1|Participant Flow|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335158|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335159|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335160|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335161|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335162|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335163|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335164|NCT00793611|E2|Reported Event|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
335165|NCT00793611|E1|Reported Event|Behavioral Therapy Standard Care|received 3 behavioral therapy session
335166|NCT00793585|B3|Baseline|Total|Total of all reporting groups
335167|NCT00793585|B2|Baseline|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
335168|NCT00793585|B1|Baseline|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
335169|NCT00793585|P2|Participant Flow|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
335170|NCT00793585|P1|Participant Flow|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
335171|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
335172|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
335173|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
335174|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
335175|NCT00793585|E2|Reported Event|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
335176|NCT00793585|E1|Reported Event|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
335177|NCT00793546|B3|Baseline|Total|Total of all reporting groups
335178|NCT00793546|B2|Baseline|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335179|NCT00793546|B1|Baseline|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335180|NCT00793546|P2|Participant Flow|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335181|NCT00793546|P1|Participant Flow|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335182|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335183|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335184|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335185|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335186|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335187|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335188|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335189|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335190|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335191|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335192|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335193|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335194|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335195|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335196|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335197|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335198|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335199|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335200|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335201|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335202|NCT00793546|O2|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335203|NCT00793546|O1|Outcome|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335204|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
335205|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335206|NCT00793546|E2|Reported Event|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335207|NCT00793546|E1|Reported Event|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
335208|NCT00793520|B3|Baseline|Total|Total of all reporting groups
335209|NCT00793520|B2|Baseline|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
336388|NCT00790218|O2|Outcome|CF102 5mg|CF102 tablets given orally, BID
335210|NCT00793520|B1|Baseline|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
335211|NCT00793520|P2|Participant Flow|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
335212|NCT00793520|P1|Participant Flow|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
335213|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
335214|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
335215|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
335216|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
335217|NCT00793520|E2|Reported Event|Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
335218|NCT00793520|E1|Reported Event|Milnacipran|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
335219|NCT00793455|B3|Baseline|Total|Total of all reporting groups
335220|NCT00793455|B2|Baseline|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
335221|NCT00793455|B1|Baseline|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
335222|NCT00793455|P2|Participant Flow|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
335223|NCT00793455|P1|Participant Flow|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
335224|NCT00793455|O2|Outcome|Intervention Group|Received outreach intervention
335225|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
335226|NCT00793455|O2|Outcome|Intervention Group|Received Educational Outreach
335227|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
335228|NCT00793455|E2|Reported Event|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
335229|NCT00793455|E1|Reported Event|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
335230|NCT00793403|B1|Baseline|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335231|NCT00793403|P1|Participant Flow|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335232|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335233|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335234|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335235|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335236|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335237|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335238|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
336389|NCT00790218|O1|Outcome|CF102 1mg|CF102 tablets given orally, BID
335239|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335240|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335241|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335242|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335243|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335244|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335245|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335246|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335247|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335248|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335249|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335250|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335251|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335252|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335253|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335254|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335255|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335256|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335257|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335258|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335281|NCT00793325|O2|Outcome|Participants Without Concomitant Drug(s)|Participants taking no concomitant drugs while taking somatropin for SGA according to Japanese package insert.
335259|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335260|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335261|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335262|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335263|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335264|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335265|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335266|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335267|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335268|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335269|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335270|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335271|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335272|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335273|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335274|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335275|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335276|NCT00793403|E1|Reported Event|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
335277|NCT00793325|B1|Baseline|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
335278|NCT00793325|P1|Participant Flow|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
335279|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the height SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
335280|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the growth rate SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
335282|NCT00793325|O1|Outcome|Participants With Concomitant Drug(s)|Participants taking concomitant drug(s) while taking somatropin for SGA according to Japanese package insert.
335283|NCT00793325|O2|Outcome|Participants Without Renal Impairment|Participants without renal impairment taking somatropin for SGA according to Japanese package insert.
335284|NCT00793325|O1|Outcome|Participants With Renal Impairment|Participants with renal impairment taking somatropin for SGA according to Japanese package insert.
335285|NCT00793325|O2|Outcome|Participants Without Hepatic Function Disorder|Participants without hepatic function disorder taking somatropin for SGA according to Japanese package insert.
335286|NCT00793325|O1|Outcome|Participants With Hepatic Function Disorder|Participants with hepatic function disorder taking somatropin for SGA according to Japanese package insert.
335287|NCT00793325|O2|Outcome|Participants Without Complication(s)|Participants without complications while taking somatropin for SGA according to Japanese package insert.
335288|NCT00793325|O1|Outcome|Participants With Complication(s)|Participants with complication(s) while taking somatropin for SGA according to Japanese package insert.
335289|NCT00793325|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for SGA according to Japanese package insert.
335290|NCT00793325|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for SGA according to Japanese package insert.
335291|NCT00793325|O3|Outcome|Severe SGA|Participants with severe SGA taking somatropin for SGA according to Japanese package insert.
335292|NCT00793325|O2|Outcome|Moderate SGA|Participants with moderate SGA taking somatropin for SGA according to Japanese package insert.
335293|NCT00793325|O1|Outcome|Mild SGA|Participants with mild SGA taking somatropin for SGA according to Japanese package insert.
335294|NCT00793325|O2|Outcome|Female|Female Participants taking somatropin for SGA according to Japanese package insert.
335295|NCT00793325|O1|Outcome|Male|Male Participants taking somatropin for SGA according to Japanese package insert.
335296|NCT00793325|O2|Outcome|>=15 Years|Participants 15 years of age or older when taking somatropin for SGA according to Japanese package insert.
335297|NCT00793325|O1|Outcome|<15 Years|Participants younger than 15 years of age when taking somatropin for SGA according to Japanese package insert.
335298|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
335299|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
335300|NCT00793325|E1|Reported Event|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
335301|NCT00793169|B1|Baseline|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
335302|NCT00793169|P1|Participant Flow|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
335303|NCT00793169|O1|Outcome|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
335304|NCT00793169|E1|Reported Event|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
335305|NCT00793104|B1|Baseline|CR Plug|Placement of allograft CR Plug in primary injury site
335306|NCT00793104|P1|Participant Flow|CR Plug|Placement of allograft CR Plug in primary injury site
335307|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
335308|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
335309|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
335310|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
335311|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
335312|NCT00793104|E1|Reported Event|CR Plug|Placement of allograft CR Plug in primary injury site
335313|NCT00792935|B3|Baseline|Total|Total of all reporting groups
335314|NCT00792935|B2|Baseline|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335315|NCT00792935|B1|Baseline|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335316|NCT00792935|P2|Participant Flow|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335317|NCT00792935|P1|Participant Flow|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335337|NCT00792688|B4|Baseline|Total|Total of all reporting groups
336390|NCT00790218|E3|Reported Event|CF102 25mg|CF102: CF102 capsules twice daily by mouth
335318|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335319|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335320|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335321|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
335322|NCT00792935|E2|Reported Event|Glimepiride|All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
335323|NCT00792935|E1|Reported Event|MK-0941|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
335324|NCT00792805|B4|Baseline|Total|Total of all reporting groups
335325|NCT00792805|B3|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335326|NCT00792805|B2|Baseline|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335327|NCT00792805|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335328|NCT00792805|P3|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335329|NCT00792805|P2|Participant Flow|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335330|NCT00792805|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335331|NCT00792805|O3|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335332|NCT00792805|O2|Outcome|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335333|NCT00792805|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335334|NCT00792805|E3|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335335|NCT00792805|E2|Reported Event|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335336|NCT00792805|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
335338|NCT00792688|B3|Baseline|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335339|NCT00792688|B2|Baseline|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335340|NCT00792688|B1|Baseline|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335341|NCT00792688|P3|Participant Flow|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335342|NCT00792688|P2|Participant Flow|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335343|NCT00792688|P1|Participant Flow|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335344|NCT00792688|O3|Outcome|All Treatments Placebo|
335345|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
335346|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
335347|NCT00792688|O3|Outcome|All Treatments Placebo|
335348|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
335349|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
335350|NCT00792688|E3|Reported Event|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335351|NCT00792688|E2|Reported Event|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335352|NCT00792688|E1|Reported Event|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
335353|NCT00792636|B4|Baseline|Total|Total of all reporting groups
335354|NCT00792636|B3|Baseline|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335355|NCT00792636|B2|Baseline|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335356|NCT00792636|B1|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335357|NCT00792636|P3|Participant Flow|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335358|NCT00792636|P2|Participant Flow|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335359|NCT00792636|P1|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335360|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335361|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335362|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335363|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335364|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335365|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335366|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335367|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335368|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335369|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335370|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335371|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335372|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335373|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335374|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335375|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335376|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335377|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335378|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335379|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335380|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335381|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
337971|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
335382|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335383|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335384|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335385|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335386|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335387|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335388|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335389|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335390|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335391|NCT00792636|O1|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335392|NCT00792636|E3|Reported Event|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
335393|NCT00792636|E2|Reported Event|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
335394|NCT00792636|E1|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
335395|NCT00792610|B1|Baseline|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
335396|NCT00792610|P1|Participant Flow|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
335397|NCT00792610|O1|Outcome|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
335398|NCT00792610|E1|Reported Event|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
335399|NCT00792298|B1|Baseline|All Treated Participants|All randomized participants who received at least one dose of study treatment.
335400|NCT00792298|P8|Participant Flow|Placebo → Suvorexant 80 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
335401|NCT00792298|P7|Participant Flow|Suvorexant 80 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
335402|NCT00792298|P6|Participant Flow|Placebo → Suvorexant 40 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
335403|NCT00792298|P5|Participant Flow|Suvorexant 40 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
335404|NCT00792298|P4|Participant Flow|Placebo → Suvorexant 20 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
335405|NCT00792298|P3|Participant Flow|Suvorexant 20 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
335406|NCT00792298|P2|Participant Flow|Placebo → Suvorexant 10 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
335407|NCT00792298|P1|Participant Flow|Suvorexant 10 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
335408|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
335409|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
335410|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
335411|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
335412|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
335649|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335413|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335414|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335415|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335416|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335417|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
335418|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335419|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335420|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335421|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335422|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
335423|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335424|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335425|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335426|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335427|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
335428|NCT00792298|E5|Reported Event|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335429|NCT00792298|E4|Reported Event|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335430|NCT00792298|E3|Reported Event|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335431|NCT00792298|E2|Reported Event|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
335432|NCT00792298|E1|Reported Event|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
335433|NCT00792259|B4|Baseline|Total|Total of all reporting groups
335434|NCT00792259|B3|Baseline|Glaucoma Subjects|Glaucoma subjects presented with pathology
335435|NCT00792259|B2|Baseline|Retinal Disease Subjects|Retinal Disease subjects with ocular pathology
335436|NCT00792259|B1|Baseline|Normal Subjects|Normal Subjects with no known ocular pathology
335437|NCT00792259|P3|Participant Flow|Glaucoma Subjects|Subjects presented with Glaucoma
335438|NCT00792259|P2|Participant Flow|Normal Subjects|Normal subjects with no known ocular pathology
335439|NCT00792259|P1|Participant Flow|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
335440|NCT00792259|O3|Outcome|Glaucoma Subjects|Subjects presented with glaucoma
335441|NCT00792259|O2|Outcome|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
335442|NCT00792259|O1|Outcome|Normal Subjects|Normal subjects with no known ocular pathology
335443|NCT00792259|E3|Reported Event|Glaucoma Subjects|Subjects presented with glaucoma
335444|NCT00792259|E2|Reported Event|Normal Subjects|Normal subjects with no known ocular pathology
335445|NCT00792259|E1|Reported Event|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
335446|NCT00792116|B3|Baseline|Total|Total of all reporting groups
335447|NCT00792116|B2|Baseline|Non-Gum Chewing|
335448|NCT00792116|B1|Baseline|Gum Chewing|
335449|NCT00792116|P2|Participant Flow|Non-Gum Chewing|
335450|NCT00792116|P1|Participant Flow|Gum Chewing|
335451|NCT00792116|O2|Outcome|Non-Gum Chewing|
335452|NCT00792116|O1|Outcome|Gum Chewing|
335453|NCT00792116|O2|Outcome|Non-Gum Chewing|
335454|NCT00792116|O1|Outcome|Gum Chewing|
335455|NCT00792116|O2|Outcome|Non-Gum Chewing|
335456|NCT00792116|O1|Outcome|Gum Chewing|
335457|NCT00792116|O2|Outcome|Non-Gum Chewing|
335458|NCT00792116|O1|Outcome|Gum Chewing|
335459|NCT00792103|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335460|NCT00792103|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335461|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335462|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335505|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335463|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335464|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335465|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335466|NCT00792103|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
335467|NCT00791999|B5|Baseline|Total|Total of all reporting groups
335468|NCT00791999|B4|Baseline|Placebo|Placebo given every 2 weeks
335469|NCT00791999|B3|Baseline|CDP870 400mg|400mg CDP870 given every 2 weeks
335470|NCT00791999|B2|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
335471|NCT00791999|B1|Baseline|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
335472|NCT00791999|P4|Participant Flow|Placebo|Placebo given every 2 weeks
335473|NCT00791999|P3|Participant Flow|CDP870 400mg|400mg CDP870 given every 2 weeks
335474|NCT00791999|P2|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
335475|NCT00791999|P1|Participant Flow|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
335476|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
335477|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
335478|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
335479|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
335480|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
335481|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
335482|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
335483|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
335484|NCT00791999|E4|Reported Event|Placebo|Placebo given every 2 weeks
335485|NCT00791999|E3|Reported Event|CDP870 400mg|400mg CDP870 given every 2 weeks
335486|NCT00791999|E2|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
335487|NCT00791999|E1|Reported Event|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
335488|NCT00791973|B3|Baseline|Total|Total of all reporting groups
335489|NCT00791973|B2|Baseline|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
335490|NCT00791973|B1|Baseline|Veramyst, Then Placbeo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
335491|NCT00791973|P2|Participant Flow|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
335492|NCT00791973|P1|Participant Flow|Veramyst, Then Placebo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
335493|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
335494|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
335495|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
335496|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
335497|NCT00791973|E2|Reported Event|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
335498|NCT00791973|E1|Reported Event|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
335499|NCT00791934|B1|Baseline|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335500|NCT00791934|P1|Participant Flow|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
335501|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335502|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335503|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335504|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335506|NCT00791934|E1|Reported Event|Stratus Microflow Ethmoid Spacer|Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
335507|NCT00791921|B3|Baseline|Total|Total of all reporting groups
335508|NCT00791921|B2|Baseline|Placebo|Placebo of CDP870
335509|NCT00791921|B1|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
335510|NCT00791921|P2|Participant Flow|Placebo|Placebo of CDP870
335511|NCT00791921|P1|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
335512|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
335513|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
335514|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
335515|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
335516|NCT00791921|E2|Reported Event|Placebo|Placebo of CDP870
335517|NCT00791921|E1|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
335518|NCT00791908|B1|Baseline|Subjects|
335519|NCT00791908|P1|Participant Flow|Subjects|
335520|NCT00791908|O3|Outcome|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
335521|NCT00791908|O2|Outcome|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
335522|NCT00791908|O1|Outcome|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
335523|NCT00791908|E3|Reported Event|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
335524|NCT00791908|E2|Reported Event|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
335525|NCT00791908|E1|Reported Event|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
335526|NCT00791817|B3|Baseline|Total|Total of all reporting groups
335527|NCT00791817|B2|Baseline|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
335528|NCT00791817|B1|Baseline|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
335529|NCT00791817|P2|Participant Flow|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
335530|NCT00791817|P1|Participant Flow|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
335531|NCT00791817|O2|Outcome|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
335532|NCT00791817|O1|Outcome|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
335533|NCT00791817|E2|Reported Event|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
335534|NCT00791817|E1|Reported Event|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
335535|NCT00791778|B3|Baseline|Total|Total of all reporting groups
335536|NCT00791778|B2|Baseline|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335537|NCT00791778|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335538|NCT00791778|P2|Participant Flow|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335539|NCT00791778|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335540|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335541|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335542|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335543|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335544|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335545|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335546|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335547|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335548|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335549|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335550|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335551|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335552|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335553|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335554|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335555|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335556|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335557|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335558|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335559|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335560|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335561|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335562|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335563|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335564|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335565|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335566|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335567|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335568|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335569|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335570|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335571|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335572|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335573|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335574|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335575|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335576|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335577|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335578|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335579|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335580|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335581|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335582|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335583|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335584|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335585|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335586|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335587|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335588|NCT00791778|E2|Reported Event|Placebo|Participants received 2 matching placebo tablets per oral twice daily
335589|NCT00791778|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
335590|NCT00791765|B3|Baseline|Total|Total of all reporting groups
335591|NCT00791765|B2|Baseline|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335592|NCT00791765|B1|Baseline|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335593|NCT00791765|P2|Participant Flow|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335594|NCT00791765|P1|Participant Flow|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335595|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335596|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335597|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335598|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335599|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335600|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335753|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335601|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335602|NCT00791765|E2|Reported Event|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
335603|NCT00791765|E1|Reported Event|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
335604|NCT00791700|B5|Baseline|Total|Total of all reporting groups
335605|NCT00791700|B4|Baseline|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335606|NCT00791700|B3|Baseline|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335607|NCT00791700|B2|Baseline|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335608|NCT00791700|B1|Baseline|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
335609|NCT00791700|P4|Participant Flow|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335610|NCT00791700|P3|Participant Flow|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335611|NCT00791700|P2|Participant Flow|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335612|NCT00791700|P1|Participant Flow|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
335613|NCT00791700|O3|Outcome|Other Failure/Remainder|Participants with other failures
335614|NCT00791700|O2|Outcome|PDVF|Participants who meet the protocol-defined virologic failure
335615|NCT00791700|O1|Outcome|Response|Participants with plasma HIV-1 RNA <48 copies/mL
335616|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335617|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335618|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335619|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335620|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335621|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335622|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335623|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335624|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335625|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335626|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335627|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335628|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335629|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335630|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335631|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335632|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335633|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335634|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335635|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335636|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335637|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335638|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335639|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335640|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335641|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335642|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335643|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335644|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335645|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335646|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335647|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335648|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335650|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335651|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335652|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335653|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335654|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335655|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335656|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335657|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335658|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335659|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335660|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335661|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335662|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335663|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335664|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335665|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335666|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335667|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335668|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335669|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335670|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335671|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335672|NCT00791700|O8|Outcome|Cohort 4 (Grade 4)|>=12 - <18 years of age, MVC tablet formulation
335673|NCT00791700|O7|Outcome|Cohort 4 (Grade 3)|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335674|NCT00791700|O6|Outcome|Cohort 3 (Grade 4)|>=6- <12years of age, MVC liquid formulation
335675|NCT00791700|O5|Outcome|Cohort 3 (Grade 3)|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335676|NCT00791700|O4|Outcome|Cohort 2 (Grade 4)|>=6 - <12 years of age, MVC tablet formulation
335677|NCT00791700|O3|Outcome|Cohort 2 (Grade 3)|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335678|NCT00791700|O2|Outcome|Cohort 1 (Grade 4)|>=2 - <6 years of age, MVC liquid formulation
335679|NCT00791700|O1|Outcome|Cohort 1 (Grade 3)|>=2 - <6 years of age, MVC liquid formulation
335680|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335681|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335682|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335683|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335684|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335685|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335686|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335687|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335688|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335689|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335690|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335691|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
335692|NCT00791700|E4|Reported Event|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
335693|NCT00791700|E3|Reported Event|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
335694|NCT00791700|E2|Reported Event|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
335695|NCT00791700|E1|Reported Event|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
335696|NCT00791661|B4|Baseline|Total|Total of all reporting groups
335697|NCT00791661|B3|Baseline|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335698|NCT00791661|B2|Baseline|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335699|NCT00791661|B1|Baseline|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335700|NCT00791661|P3|Participant Flow|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335701|NCT00791661|P2|Participant Flow|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335702|NCT00791661|P1|Participant Flow|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
335703|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
335704|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
335705|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335706|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335707|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335708|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335709|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335710|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335711|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335712|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335713|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335714|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
335715|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
335716|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335717|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335718|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335719|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335720|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335721|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335722|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335723|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335724|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335725|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335726|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335727|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335728|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335729|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335730|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335731|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335732|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335733|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335734|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335735|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335736|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335737|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335738|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335739|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335740|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335741|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335742|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335743|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335744|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335745|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335746|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335747|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335748|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335749|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335750|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335751|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335752|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335756|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335757|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335758|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335759|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335760|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335761|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335762|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335763|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335764|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335765|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335766|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335767|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335768|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335769|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335770|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
335771|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
335772|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335773|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335774|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335775|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335776|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335777|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335778|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335779|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335780|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335781|NCT00791661|E11|Reported Event|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
335782|NCT00791661|E10|Reported Event|Placebo|Participants received matching placebo to MK-1006
335783|NCT00791661|E9|Reported Event|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
335784|NCT00791661|E8|Reported Event|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
335785|NCT00791661|E7|Reported Event|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
335786|NCT00791661|E6|Reported Event|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
335787|NCT00791661|E5|Reported Event|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
335788|NCT00791661|E4|Reported Event|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
335789|NCT00791661|E3|Reported Event|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
335790|NCT00791661|E2|Reported Event|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
335791|NCT00791661|E1|Reported Event|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
335792|NCT00791557|B1|Baseline|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
335793|NCT00791557|P1|Participant Flow|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
335794|NCT00791557|O1|Outcome|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
335795|NCT00791557|E1|Reported Event|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
335796|NCT00791518|B1|Baseline|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335797|NCT00791518|P1|Participant Flow|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335798|NCT00791518|O4|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
335799|NCT00791518|O3|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
335800|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
335801|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
335802|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
335803|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
335804|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
335805|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
335806|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
335807|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
335808|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
335809|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
335810|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50%
335811|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50%
335812|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
335813|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
335814|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
335815|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50%
335816|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
335817|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
335818|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335819|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335820|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335821|NCT00791518|E1|Reported Event|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
335822|NCT00791492|B3|Baseline|Total|Total of all reporting groups
335823|NCT00791492|B2|Baseline|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335824|NCT00791492|B1|Baseline|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335825|NCT00791492|P2|Participant Flow|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335826|NCT00791492|P1|Participant Flow|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335827|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335828|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
338782|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
335829|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335830|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335831|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335832|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335833|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335834|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335835|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335836|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335837|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335838|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335839|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335840|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335841|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335842|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335843|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335844|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335845|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335846|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335847|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335848|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335849|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335850|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335851|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335852|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335853|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335854|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335855|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335856|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335857|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335858|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335859|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335860|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335861|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335862|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335863|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335864|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335865|NCT00791492|E2|Reported Event|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335866|NCT00791492|E1|Reported Event|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
335867|NCT00791479|B7|Baseline|Total|Total of all reporting groups
335868|NCT00791479|B6|Baseline|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335869|NCT00791479|B5|Baseline|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335870|NCT00791479|B4|Baseline|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335871|NCT00791479|B3|Baseline|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335872|NCT00791479|B2|Baseline|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335873|NCT00791479|B1|Baseline|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335874|NCT00791479|P6|Participant Flow|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335875|NCT00791479|P5|Participant Flow|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335876|NCT00791479|P4|Participant Flow|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335877|NCT00791479|P3|Participant Flow|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335878|NCT00791479|P2|Participant Flow|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335879|NCT00791479|P1|Participant Flow|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335880|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335881|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335882|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335883|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335884|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335885|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335886|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335887|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335888|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335889|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335890|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335891|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335892|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335893|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335894|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335895|NCT00791479|O6|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335896|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335897|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335898|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335899|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335900|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335901|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335902|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335903|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335904|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335905|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335906|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335907|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335908|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335909|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335910|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335911|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335912|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335913|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335914|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335915|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335916|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335917|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335918|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335919|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335920|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335921|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335922|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335923|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335924|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335925|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335926|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335927|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335928|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335929|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335930|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335931|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335932|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335933|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335934|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335935|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335936|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335937|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335938|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335939|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335940|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335941|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335942|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335943|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335944|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335945|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335946|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335947|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335948|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335949|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335950|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335951|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335952|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335953|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335954|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335955|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335956|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335957|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335958|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335959|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335960|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335961|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335962|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335963|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335964|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335965|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
335966|NCT00791479|E6|Reported Event|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335967|NCT00791479|E5|Reported Event|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335968|NCT00791479|E4|Reported Event|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335969|NCT00791479|E3|Reported Event|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335970|NCT00791479|E2|Reported Event|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335971|NCT00791479|E1|Reported Event|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
335972|NCT00790569|B4|Baseline|Total|Total of all reporting groups
335973|NCT00790569|B3|Baseline|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335974|NCT00790569|B2|Baseline|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335975|NCT00790569|B1|Baseline|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335976|NCT00790569|P3|Participant Flow|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335977|NCT00790569|P2|Participant Flow|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335978|NCT00790569|P1|Participant Flow|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335979|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335980|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335981|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335982|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335983|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335984|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335985|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335986|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335987|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335988|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335989|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335990|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335991|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335992|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335993|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335994|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
336391|NCT00790218|E2|Reported Event|CF102 5mg|CF102: CF102 capsules twice daily by mouth
335995|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335996|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
335997|NCT00790569|E3|Reported Event|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
335998|NCT00790569|E2|Reported Event|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
335999|NCT00790569|E1|Reported Event|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
336000|NCT00790556|B1|Baseline|All Participants|All participants
336001|NCT00790556|P2|Participant Flow|Placebo Then MK8245|"During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
336002|NCT00790556|P1|Participant Flow|MK8245 Then Placebo|"During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
336003|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336004|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336005|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336006|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336007|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336008|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336009|NCT00790556|E2|Reported Event|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336010|NCT00790556|E1|Reported Event|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
336011|NCT00791388|B6|Baseline|Total|Total of all reporting groups
336012|NCT00791388|B5|Baseline|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336013|NCT00791388|B4|Baseline|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336014|NCT00791388|B3|Baseline|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336015|NCT00791388|B2|Baseline|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336016|NCT00791388|B1|Baseline|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336017|NCT00791388|P5|Participant Flow|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336018|NCT00791388|P4|Participant Flow|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336019|NCT00791388|P3|Participant Flow|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336020|NCT00791388|P2|Participant Flow|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336021|NCT00791388|P1|Participant Flow|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336022|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336023|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336392|NCT00790218|E1|Reported Event|CF102 1mg|CF102: CF102 capsules twice daily by mouth
336024|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336025|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336026|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336027|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336028|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336029|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336030|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336031|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336032|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336033|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336034|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336035|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336036|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336037|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336038|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336039|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336040|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336041|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336042|NCT00791388|E5|Reported Event|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
336043|NCT00791388|E4|Reported Event|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
336044|NCT00791388|E3|Reported Event|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
336045|NCT00791388|E2|Reported Event|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
336046|NCT00791388|E1|Reported Event|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
336047|NCT00791323|B3|Baseline|Total|Total of all reporting groups
336048|NCT00791323|B2|Baseline|Soothe® XP|Mineral Oil Emollient
336049|NCT00791323|B1|Baseline|Ketorolac 0.4%|Ketorolac 0.4%
336050|NCT00791323|P2|Participant Flow|Soothe® XP|Mineral Oil Emollient
336051|NCT00791323|P1|Participant Flow|Ketorolac 0.4%|Ketorolac 0.4%
336052|NCT00791323|O2|Outcome|Soothe® XP|Mineral Oil Emollient
336053|NCT00791323|O1|Outcome|Ketorolac 0.4%|Ketorolac 0.4%
336054|NCT00791323|E2|Reported Event|Soothe® XP|Mineral Oil Emollient
336055|NCT00791323|E1|Reported Event|Ketorolac 0.4%|Ketorolac 0.4%
336056|NCT00791258|B1|Baseline|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336393|NCT00790205|B3|Baseline|Total|Total of all reporting groups
336057|NCT00791258|P1|Participant Flow|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336058|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336059|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336060|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336061|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336062|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336063|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336064|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336065|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336066|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336067|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336068|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336069|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336070|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336071|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336072|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336073|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336074|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336075|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336076|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336077|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336078|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336079|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336080|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336081|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336082|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336083|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336084|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336167|NCT00790855|P1|Participant Flow|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
336085|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336086|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336087|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336088|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336089|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336090|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336091|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336092|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336093|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336094|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336095|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336096|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336097|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336098|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336099|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336100|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336101|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336102|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336103|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336104|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336105|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336106|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336107|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336108|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336109|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336110|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336111|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336112|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336168|NCT00790855|O1|Outcome|Bendamustine (75 mg/m^2)|75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
336113|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336114|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336115|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336116|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336117|NCT00791258|E1|Reported Event|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
336118|NCT00791128|B1|Baseline|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
336119|NCT00791128|P1|Participant Flow|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
336120|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
336121|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
336122|NCT00791128|E1|Reported Event|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
336123|NCT00791102|B1|Baseline|All Study Participants|
336124|NCT00791102|P2|Participant Flow|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336125|NCT00791102|P1|Participant Flow|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336126|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336127|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336128|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336129|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336130|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336131|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336132|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336133|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336134|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336135|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336136|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336137|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336138|NCT00791102|E2|Reported Event|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336139|NCT00791102|E1|Reported Event|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
336140|NCT00790907|B4|Baseline|Total|Total of all reporting groups
336141|NCT00790907|B3|Baseline|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336142|NCT00790907|B2|Baseline|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336143|NCT00790907|B1|Baseline|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
336169|NCT00790855|O1|Outcome|Bendamustine|Starting dose 50 mg/m^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m^2 for 3 levels.
336170|NCT00790855|E1|Reported Event|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
340985|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
336144|NCT00790907|P3|Participant Flow|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336145|NCT00790907|P2|Participant Flow|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336146|NCT00790907|P1|Participant Flow|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
336147|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336148|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336149|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336150|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336151|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336152|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336153|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336154|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336171|NCT00790803|B1|Baseline|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336155|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336156|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336157|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336158|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336159|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336160|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336161|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336162|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336163|NCT00790907|E3|Reported Event|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
336164|NCT00790907|E2|Reported Event|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
336165|NCT00790907|E1|Reported Event|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
336166|NCT00790855|B1|Baseline|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
340986|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
336172|NCT00790803|P1|Participant Flow|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336173|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336174|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336175|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336176|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336177|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336178|NCT00790803|E1|Reported Event|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
336179|NCT00790790|B4|Baseline|Total|Total of all reporting groups
336180|NCT00790790|B3|Baseline|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336181|NCT00790790|B2|Baseline|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336182|NCT00790790|B1|Baseline|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336183|NCT00790790|P3|Participant Flow|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336184|NCT00790790|P2|Participant Flow|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336185|NCT00790790|P1|Participant Flow|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336186|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336187|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336188|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336189|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336190|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336191|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336192|NCT00790790|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
336193|NCT00790790|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
336194|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336195|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336196|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336197|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336198|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336199|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336200|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336201|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336202|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336203|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336204|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336205|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336206|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336207|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336208|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336209|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336210|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336211|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336212|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336213|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336214|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336215|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336216|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336217|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336218|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336219|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336280|NCT00790751|E2|Reported Event|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336220|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336221|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336222|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336223|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336224|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336225|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336226|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336227|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336228|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336229|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336230|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336231|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336232|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336233|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336234|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336235|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336236|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336237|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336238|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336239|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336240|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336241|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336281|NCT00790751|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336282|NCT00790738|B3|Baseline|Total|Total of all reporting groups
336283|NCT00790738|B2|Baseline|Placebo|"placebo~placebo: placebo"
336242|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336243|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336244|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336245|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336246|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336247|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336248|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336249|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336250|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336251|NCT00790790|E6|Reported Event|LY545694 105 mg Washout|1 week washout period from taking 105 mg LY545694
336252|NCT00790790|E5|Reported Event|LY545694 49 mg Washout|1 week washout period from taking 49 mg LY545694
336253|NCT00790790|E4|Reported Event|Placebo Washout|1 week washout period from taking placebo
336254|NCT00790790|E3|Reported Event|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
336255|NCT00790790|E2|Reported Event|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
336256|NCT00790790|E1|Reported Event|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
336257|NCT00790751|B5|Baseline|Total|Total of all reporting groups
336258|NCT00790751|B4|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336259|NCT00790751|B3|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336260|NCT00790751|B2|Baseline|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336261|NCT00790751|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336262|NCT00790751|P4|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336263|NCT00790751|P3|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336264|NCT00790751|P2|Participant Flow|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336265|NCT00790751|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336266|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336267|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336268|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336269|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336270|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336271|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336272|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336273|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336274|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336275|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336276|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
336277|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
336278|NCT00790751|E4|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
336279|NCT00790751|E3|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
336284|NCT00790738|B1|Baseline|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
336285|NCT00790738|P2|Participant Flow|Placebo|"placebo~placebo: placebo"
336286|NCT00790738|P1|Participant Flow|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
336287|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
336288|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
336289|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
336290|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
336291|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
336292|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
336293|NCT00790738|E2|Reported Event|Placebo|"placebo~placebo: placebo"
336294|NCT00790738|E1|Reported Event|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
336295|NCT00790673|B5|Baseline|Total|Total of all reporting groups
336296|NCT00790673|B4|Baseline|Placebo|Placebo: Matching placebo capsules
336297|NCT00790673|B3|Baseline|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
336298|NCT00790673|B2|Baseline|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
336299|NCT00790673|B1|Baseline|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
336300|NCT00790673|P4|Participant Flow|Placebo|Placebo: Matching placebo capsules
336301|NCT00790673|P3|Participant Flow|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
336302|NCT00790673|P2|Participant Flow|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
336303|NCT00790673|P1|Participant Flow|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
336304|NCT00790673|O4|Outcome|Placebo|Placebo: Matching placebo capsules
336305|NCT00790673|O3|Outcome|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
336306|NCT00790673|O2|Outcome|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
336307|NCT00790673|O1|Outcome|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
336308|NCT00790673|E4|Reported Event|Placebo|Placebo: Matching placebo capsules
336309|NCT00790673|E3|Reported Event|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
336310|NCT00790673|E2|Reported Event|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
336311|NCT00790673|E1|Reported Event|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
336312|NCT00790647|B1|Baseline|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336313|NCT00790647|P1|Participant Flow|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336314|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336315|NCT00790647|O1|Outcome|Stem Cell Transplantation With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336316|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336317|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336318|NCT00790647|E1|Reported Event|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
336319|NCT00790452|B3|Baseline|Total|Total of all reporting groups
336320|NCT00790452|B2|Baseline|Group 2 (Placebo)|Tablet/day orally
336321|NCT00790452|B1|Baseline|Group 1 (Aspirin)|Aspirin 325 mg/day orally
336322|NCT00790452|P2|Participant Flow|Group 2 (Placebo)|Tablet/day orally
336323|NCT00790452|P1|Participant Flow|Group 1 (Aspirin)|Aspirin 325 mg/day orally
336324|NCT00790452|O2|Outcome|Group 2 (Placebo)|Tablet/day orally
336325|NCT00790452|O1|Outcome|Group 1 (Aspirin)|Aspirin 325 mg/day orally
336326|NCT00790452|E2|Reported Event|Group 2 (Placebo)|Tablet/day orally
336327|NCT00790452|E1|Reported Event|Group 1 (Aspirin)|Aspirin 325 mg/day orally
336328|NCT00790400|B3|Baseline|Total|Total of all reporting groups
336329|NCT00790400|B2|Baseline|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336330|NCT00790400|B1|Baseline|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336331|NCT00790400|P2|Participant Flow|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336332|NCT00790400|P1|Participant Flow|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336333|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336334|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336335|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336336|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336337|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336338|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336339|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336340|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336341|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336342|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336343|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336344|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336345|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336346|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336347|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336348|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336349|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336350|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336351|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336352|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
336353|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
336354|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
336355|NCT00790400|E3|Reported Event|Placebo Randomized/Never Crossed-over|Patients randomized to placebo who never crossed-over to Everolimus
336356|NCT00790400|E2|Reported Event|Placebo Randomized/Crossed Over to Everolimus|Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
336357|NCT00790400|E1|Reported Event|Everolimus Randomized (Core & Ext)|Patients who were randomized and treated with Everolimus during the Core and Extension phase
336358|NCT00790296|B3|Baseline|Total|Total of all reporting groups
336359|NCT00790296|B2|Baseline|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
336360|NCT00790296|B1|Baseline|TRH Then Saline|TRH (0.5mg) given first followed by Saline
336361|NCT00790296|P2|Participant Flow|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
336362|NCT00790296|P1|Participant Flow|TRH Then Saline|TRH (0.5mg) given first followed by Saline
336363|NCT00790296|O2|Outcome|Saline|Saline given Intravenously
336364|NCT00790296|O1|Outcome|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
336365|NCT00790296|E2|Reported Event|Saline|Saline given intravenously
336366|NCT00790296|E1|Reported Event|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
336367|NCT00790270|B4|Baseline|Total|Total of all reporting groups
336368|NCT00790270|B3|Baseline|Ibuprophen Plus Cyclobenzaprine|
336369|NCT00790270|B2|Baseline|Ibuprofen|
336370|NCT00790270|B1|Baseline|Cyclobenzaprine|
336371|NCT00790270|P3|Participant Flow|Ibuprophen Plus Cyclobenzaprine|
336372|NCT00790270|P2|Participant Flow|Ibuprofen|
336373|NCT00790270|P1|Participant Flow|Cyclobenzaprine|
336374|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
336375|NCT00790270|O2|Outcome|Ibuprofen|
336376|NCT00790270|O1|Outcome|Cyclobenzaprine|
336377|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
336378|NCT00790270|O2|Outcome|Ibuprofen|
336379|NCT00790270|O1|Outcome|Cyclobenzaprine|
336380|NCT00790270|E3|Reported Event|Ibuprophen Plus Cyclobenzaprine|
336381|NCT00790270|E2|Reported Event|Ibuprofen|
336382|NCT00790270|E1|Reported Event|Cyclobenzaprine|
336383|NCT00790218|B1|Baseline|CF102|CF102: CF102 capsules twice daily by mouth
336384|NCT00790218|P3|Participant Flow|CF102 25mg|CF102: CF102 tablets were given orally twice daily
336385|NCT00790218|P2|Participant Flow|CF102 5mg|CF102: CF102 tablets were given orally twice daily
336386|NCT00790218|P1|Participant Flow|CF102 1mg|CF102: CF102 tablets were given orally twice daily
336394|NCT00790205|B2|Baseline|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336395|NCT00790205|B1|Baseline|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336396|NCT00790205|P2|Participant Flow|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336397|NCT00790205|P1|Participant Flow|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336398|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336399|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336400|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336401|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336402|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336403|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336404|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336405|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336406|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336407|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336408|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336409|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336410|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336411|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336412|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336413|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336414|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336415|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336416|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336417|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336418|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336419|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336420|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336421|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336422|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336423|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336424|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336425|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336426|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336427|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336428|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336429|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336430|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336431|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336432|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336433|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336434|NCT00790205|E2|Reported Event|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
336435|NCT00790205|E1|Reported Event|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
336436|NCT00790192|B5|Baseline|Total|Total of all reporting groups
336437|NCT00790192|B4|Baseline|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
336438|NCT00790192|B3|Baseline|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
336439|NCT00790192|B2|Baseline|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
336440|NCT00790192|B1|Baseline|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
336441|NCT00790192|P4|Participant Flow|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
336442|NCT00790192|P3|Participant Flow|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
336443|NCT00790192|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
336444|NCT00790192|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
336445|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
336446|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
336447|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
336448|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
336449|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
336450|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
336451|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
336452|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
336453|NCT00790192|E4|Reported Event|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
336454|NCT00790192|E3|Reported Event|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
336455|NCT00790192|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
336456|NCT00790192|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
336457|NCT00790062|B4|Baseline|Total|Total of all reporting groups
336458|NCT00790062|B3|Baseline|Oxytocin 80U/500cc|
336459|NCT00790062|B2|Baseline|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336460|NCT00790062|B1|Baseline|Oxytocin 10 Units/500cc|
336461|NCT00790062|P3|Participant Flow|Oxytocin 80U/500cc|
336462|NCT00790062|P2|Participant Flow|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336463|NCT00790062|P1|Participant Flow|Oxytocin 10 Units/500cc|
336464|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
336465|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
336466|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
336467|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
336468|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336469|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
336470|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
336471|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336472|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
336473|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
336474|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336475|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
336476|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
336477|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336478|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
336479|NCT00790062|O3|Outcome|Oxytocin 80U/500cc Over 1 Hour|
336480|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc Over 1 Hour|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336481|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc Over 1 Hour|
336482|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
336483|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
336484|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
336485|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|1 dose only for prophylaxsis given over 1 hour
336486|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~1 dose only for prophylaxsis given over 1 hour"
336487|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|1 dose only for prophylaxsis given over 1 hour
336488|NCT00790062|E3|Reported Event|Oxytocin 80U/500cc|
336489|NCT00790062|E2|Reported Event|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
336490|NCT00790062|E1|Reported Event|Oxytocin 10 Units/500cc|
336491|NCT00790023|B4|Baseline|Total|Total of all reporting groups
336492|NCT00790023|B3|Baseline|Placebo|Placebo once daily
336493|NCT00790023|B2|Baseline|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336494|NCT00790023|B1|Baseline|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336495|NCT00790023|P3|Participant Flow|Placebo|Placebo once daily
336496|NCT00790023|P2|Participant Flow|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336497|NCT00790023|P1|Participant Flow|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336498|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336499|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336500|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336501|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336502|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336503|NCT00790023|O3|Outcome|Placebo|
336504|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336505|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336506|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336507|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336508|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336509|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336510|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336511|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336512|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336513|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336514|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336515|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336516|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336517|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336518|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336519|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336520|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336521|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336522|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336523|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336524|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336525|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336526|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336527|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336528|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336529|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336530|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336531|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336532|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336533|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336534|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336535|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336536|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336537|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336538|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336539|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336540|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336541|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336542|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336543|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336544|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336545|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336546|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336547|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336548|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336549|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336550|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336551|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336552|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336553|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336554|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336555|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336556|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336557|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336558|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336559|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336560|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336561|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336562|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336563|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336564|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336565|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336566|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336567|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336568|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336569|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336570|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336571|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336572|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336573|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336574|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336575|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336576|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336577|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336578|NCT00790023|O3|Outcome|Placebo|Placebo once daily
336579|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336580|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336581|NCT00790023|E3|Reported Event|Placebo|Placebo once daily
336582|NCT00790023|E2|Reported Event|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
336583|NCT00790023|E1|Reported Event|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
336584|NCT00789997|B3|Baseline|Total|Total of all reporting groups
336585|NCT00789997|B2|Baseline|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
336838|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336586|NCT00789997|B1|Baseline|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
336587|NCT00789997|P2|Participant Flow|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
336588|NCT00789997|P1|Participant Flow|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
336589|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
336590|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
336591|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
336592|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
336593|NCT00789997|E2|Reported Event|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
336594|NCT00789997|E1|Reported Event|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
336595|NCT00789958|B1|Baseline|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336596|NCT00789958|P1|Participant Flow|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336597|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336598|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
336599|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
336600|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336601|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
336602|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
336603|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336604|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336605|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
336606|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
336607|NCT00789958|E1|Reported Event|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
336608|NCT00789880|B7|Baseline|Total|Total of all reporting groups
336609|NCT00789880|B6|Baseline|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336610|NCT00789880|B5|Baseline|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336611|NCT00789880|B4|Baseline|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336612|NCT00789880|B3|Baseline|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336613|NCT00789880|B2|Baseline|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336614|NCT00789880|B1|Baseline|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336615|NCT00789880|P6|Participant Flow|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336616|NCT00789880|P5|Participant Flow|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336617|NCT00789880|P4|Participant Flow|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336618|NCT00789880|P3|Participant Flow|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336619|NCT00789880|P2|Participant Flow|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336620|NCT00789880|P1|Participant Flow|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336621|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336622|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336623|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336624|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336625|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336626|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336627|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336628|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336629|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336630|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336631|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336632|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336633|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336634|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336839|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336635|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336636|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336637|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336638|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336639|NCT00789880|E6|Reported Event|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
336640|NCT00789880|E5|Reported Event|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
336641|NCT00789880|E4|Reported Event|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
336642|NCT00789880|E3|Reported Event|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336643|NCT00789880|E2|Reported Event|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
336644|NCT00789880|E1|Reported Event|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
336645|NCT00789854|B4|Baseline|Total|Total of all reporting groups
336646|NCT00789854|B3|Baseline|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336647|NCT00789854|B2|Baseline|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336648|NCT00789854|B1|Baseline|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336649|NCT00789854|P3|Participant Flow|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336650|NCT00789854|P2|Participant Flow|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336651|NCT00789854|P1|Participant Flow|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336652|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336653|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336654|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336655|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336656|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336657|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336658|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336659|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336660|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336661|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336662|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336663|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336664|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336665|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336666|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336667|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336668|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336669|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336670|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336671|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336672|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336673|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336674|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336675|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336676|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336677|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336678|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336679|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336680|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336681|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336682|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336683|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336684|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336685|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336686|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336687|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336688|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336689|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336690|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336691|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336692|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336693|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336694|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336695|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336696|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336697|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336698|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336699|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336700|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336701|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336702|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336703|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336704|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336705|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336840|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336706|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336707|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336708|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336709|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336710|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336711|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336712|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336713|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336714|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336715|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336716|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336717|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336718|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336719|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336720|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336721|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336722|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336723|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336724|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336725|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336726|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336727|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336728|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336729|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336730|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336731|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336732|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336733|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336734|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336735|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336736|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336737|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336738|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336739|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336740|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336741|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336841|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336742|NCT00789854|E3|Reported Event|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
336743|NCT00789854|E2|Reported Event|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
336744|NCT00789854|E1|Reported Event|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
336745|NCT00789828|B3|Baseline|Total|Total of all reporting groups
336746|NCT00789828|B2|Baseline|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336747|NCT00789828|B1|Baseline|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336748|NCT00789828|P2|Participant Flow|Placebo|Participants received oral dose of placebo matching to everolimus daily.
336749|NCT00789828|P1|Participant Flow|Everolimus|Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.
336750|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336751|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336752|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336753|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336754|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336755|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336756|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336757|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336758|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336759|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336760|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336761|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336762|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336763|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336764|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336765|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336766|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336767|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336768|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336769|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336770|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336771|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336772|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336842|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336843|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
340987|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
336773|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336774|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
336775|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
336776|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
336777|NCT00789828|E3|Reported Event|Placebo Treated (Core Period)|Participants who received placebo in core period.
336778|NCT00789828|E2|Reported Event|Placebo (Core) Then Everolimus Treated (Extension Period)|Participants who received placebo in core period and then received evrolimus treatment in extension period.
336779|NCT00789828|E1|Reported Event|Everolimus Treated (Core and Extension Period)|Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
336780|NCT00789815|B3|Baseline|Total|Total of all reporting groups
336781|NCT00789815|B2|Baseline|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336782|NCT00789815|B1|Baseline|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336783|NCT00789815|P2|Participant Flow|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336784|NCT00789815|P1|Participant Flow|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336785|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336786|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336787|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336788|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336789|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336790|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336791|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336792|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336793|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336794|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336795|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336844|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336845|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336846|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336796|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336797|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336798|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336799|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336800|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336801|NCT00789815|E2|Reported Event|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
336802|NCT00789815|E1|Reported Event|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
336803|NCT00789802|B4|Baseline|Total|Total of all reporting groups
336804|NCT00789802|B3|Baseline|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
336805|NCT00789802|B2|Baseline|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
336806|NCT00789802|B1|Baseline|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
336807|NCT00789802|P3|Participant Flow|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
336808|NCT00789802|P2|Participant Flow|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
336809|NCT00789802|P1|Participant Flow|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
336810|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
336811|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
336812|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
336813|NCT00789802|E3|Reported Event|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
336814|NCT00789802|E2|Reported Event|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
336815|NCT00789802|E1|Reported Event|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
336816|NCT00789737|B3|Baseline|Total|Total of all reporting groups
336817|NCT00789737|B2|Baseline|Placebo|"placebo~Placebo : placebo"
336818|NCT00789737|B1|Baseline|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336819|NCT00789737|P2|Participant Flow|Placebo|"placebo~Placebo : placebo"
336820|NCT00789737|P1|Participant Flow|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336821|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336822|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336823|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336824|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336825|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336826|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336827|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336828|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336829|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336830|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336831|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336832|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336833|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336834|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336835|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336836|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336837|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
336847|NCT00789737|E2|Reported Event|Placebo|"placebo~Placebo : placebo"
336848|NCT00789737|E1|Reported Event|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
336849|NCT00789724|B3|Baseline|Total|Total of all reporting groups
336850|NCT00789724|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
336851|NCT00789724|B1|Baseline|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
336852|NCT00789724|P2|Participant Flow|Placebo|0.67 ml of NaCl 0.9% solution
336853|NCT00789724|P1|Participant Flow|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
336854|NCT00789724|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
336855|NCT00789724|O1|Outcome|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
336856|NCT00789724|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
336857|NCT00789724|E1|Reported Event|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
336858|NCT00789698|B5|Baseline|Total|Total of all reporting groups
336859|NCT00789698|B4|Baseline|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336860|NCT00789698|B3|Baseline|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
336861|NCT00789698|B2|Baseline|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336862|NCT00789698|B1|Baseline|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336863|NCT00789698|P4|Participant Flow|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336864|NCT00789698|P3|Participant Flow|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
336865|NCT00789698|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336866|NCT00789698|P1|Participant Flow|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336867|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336868|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
336869|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336870|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
336871|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336872|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
336873|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336874|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
336875|NCT00789698|E4|Reported Event|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
336876|NCT00789698|E3|Reported Event|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
336877|NCT00789698|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336878|NCT00789698|E1|Reported Event|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
336879|NCT00789685|B1|Baseline|Safety Population|Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
336880|NCT00789685|P1|Participant Flow|Interferon Beta|"Interferon Beta~Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered."
336881|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
336882|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
336883|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
336884|NCT00789685|E1|Reported Event|Safety Population|Safety population includes all patients who received at least one dose of study medication
336885|NCT00789672|B3|Baseline|Total|Total of all reporting groups
336886|NCT00789672|B2|Baseline|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336887|NCT00789672|B1|Baseline|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336888|NCT00789672|P2|Participant Flow|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336889|NCT00789672|P1|Participant Flow|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336923|NCT00789555|P2|Participant Flow|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
340988|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
336890|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336891|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336892|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336893|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336894|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336895|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336896|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336897|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336898|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336899|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336900|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336901|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336902|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336903|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336904|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336905|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336906|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336907|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336908|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336909|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336910|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336911|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336912|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336913|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336914|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336915|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336916|NCT00789672|E2|Reported Event|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336917|NCT00789672|E1|Reported Event|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
336918|NCT00789555|B4|Baseline|Total|Total of all reporting groups
336919|NCT00789555|B3|Baseline|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336920|NCT00789555|B2|Baseline|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336921|NCT00789555|B1|Baseline|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336922|NCT00789555|P3|Participant Flow|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336924|NCT00789555|P1|Participant Flow|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336925|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336926|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336927|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336928|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336929|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336930|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336931|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336932|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336933|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336934|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336935|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336936|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336937|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336938|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336939|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336940|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336941|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336942|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336943|NCT00789555|E3|Reported Event|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
336944|NCT00789555|E2|Reported Event|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
336945|NCT00789555|E1|Reported Event|PATANASE|Two sprays in each nostril twice a day for up to 12 months
336946|NCT00789529|B3|Baseline|Total|Total of all reporting groups
336947|NCT00789529|B2|Baseline|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
336948|NCT00789529|B1|Baseline|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
336949|NCT00789529|P2|Participant Flow|2 - Opti-Free RepleniSH First, ReNu MultiPlus Second|Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
336950|NCT00789529|P1|Participant Flow|1 - ReNu MultiPlus First, Opti-Free RepleniSH Second|Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period
336951|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
336952|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
336953|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
336954|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
336955|NCT00789529|E2|Reported Event|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
336956|NCT00789529|E1|Reported Event|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
336957|NCT00789477|B6|Baseline|Total|Total of all reporting groups
336958|NCT00789477|B5|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336959|NCT00789477|B4|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
336960|NCT00789477|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336961|NCT00789477|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
336962|NCT00789477|B1|Baseline|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336963|NCT00789477|P5|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
336964|NCT00789477|P4|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
336965|NCT00789477|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
336966|NCT00789477|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336967|NCT00789477|P1|Participant Flow|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336968|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336969|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
336970|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336971|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336972|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336973|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336974|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
336975|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336976|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336977|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336978|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336979|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
336980|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336981|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336982|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336983|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336984|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
336985|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336986|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336987|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336988|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336989|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
336990|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
336991|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
336992|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336993|NCT00789477|E5|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
336994|NCT00789477|E4|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
336995|NCT00789477|E3|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
336996|NCT00789477|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
336997|NCT00789477|E1|Reported Event|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
336998|NCT00789438|B4|Baseline|Total|Total of all reporting groups
336999|NCT00789438|B3|Baseline|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
337000|NCT00789438|B2|Baseline|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
337001|NCT00789438|B1|Baseline|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
337002|NCT00789438|P3|Participant Flow|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
337003|NCT00789438|P2|Participant Flow|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
337004|NCT00789438|P1|Participant Flow|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
337005|NCT00789438|O3|Outcome|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
337006|NCT00789438|O2|Outcome|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
337007|NCT00789438|O1|Outcome|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
337008|NCT00789438|E3|Reported Event|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
337009|NCT00789438|E2|Reported Event|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
337010|NCT00789438|E1|Reported Event|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
337011|NCT00789373|B1|Baseline|Induction Pemetrexed + Cisplatin|pemetrexed plus cisplatin
337012|NCT00789373|P3|Participant Flow|Pemetrexed + Cisplatin Followed by Placebo|Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.
337013|NCT00789373|P2|Participant Flow|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
337014|NCT00789373|P1|Participant Flow|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
337015|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337016|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337017|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337018|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
337019|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337020|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337021|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337022|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337023|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337024|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337025|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337026|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337027|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337028|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337029|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
337030|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337031|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337032|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337033|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
337034|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337035|NCT00789373|E3|Reported Event|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
337036|NCT00789373|E2|Reported Event|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
337037|NCT00789373|E1|Reported Event|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
337038|NCT00787852|B3|Baseline|Total|Total of all reporting groups
337039|NCT00787852|B2|Baseline|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
337040|NCT00787852|B1|Baseline|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
337041|NCT00787852|P2|Participant Flow|Group 2: Dasatinib 70mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 70 mg daily~Maintenance x 2 years*"
337067|NCT00787839|E1|Reported Event|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
337042|NCT00787852|P1|Participant Flow|Group 1: Dasatinib 50mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 50 mg daily~Maintenance x 2 years*"
337043|NCT00787852|O2|Outcome|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
337044|NCT00787852|O1|Outcome|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
337045|NCT00787852|E2|Reported Event|Group 2|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~70 mg daily"
337046|NCT00787852|E1|Reported Event|Group 1|DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily 50 mg daily
337047|NCT00787839|B1|Baseline|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
337048|NCT00787839|P1|Participant Flow|Group 1|"Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.~Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.~Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."
337049|NCT00787839|O8|Outcome|GCTcap - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTcap screening test
337050|NCT00787839|O7|Outcome|GCTpl - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTpl screening test
337051|NCT00787839|O6|Outcome|GCTcap - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTcap screening test
337052|NCT00787839|O5|Outcome|GCTpl - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTpl screening test
337053|NCT00787839|O4|Outcome|GCTcap - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTcap screening test
337054|NCT00787839|O3|Outcome|GCTpl - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTpl screening test
337055|NCT00787839|O2|Outcome|GCTcap - Diabetes - VA|VA costs per case of diabetes identified, using the GCTcap screening test
337056|NCT00787839|O1|Outcome|GCTpl - Diabetes - VA|VA costs per case of diabetes identified, using the GCTpl screening test
337057|NCT00787839|O10|Outcome|A1c - Dysglycemia|hemoglobin A1c, measured at the time of the OGTT
337058|NCT00787839|O9|Outcome|RCG - Dysglycemia|random capillary glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337059|NCT00787839|O8|Outcome|RPG - Dysglycemia|random plasma glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337060|NCT00787839|O7|Outcome|GCTcap - Dysglycemia|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337061|NCT00787839|O6|Outcome|GCTpl - Dysglycemia|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337062|NCT00787839|O5|Outcome|A1c - Diabetes|hemoglobin A1c, measured at the time of the OGTT
337063|NCT00787839|O4|Outcome|RCG - Diabetes|random capillary glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
337064|NCT00787839|O3|Outcome|RPG - Diabetes|random plasma glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
337065|NCT00787839|O2|Outcome|GCTcap - Diabetes|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337066|NCT00787839|O1|Outcome|GCTpl - Diabetes|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
337068|NCT00787800|B3|Baseline|Total|Total of all reporting groups
337069|NCT00787800|B2|Baseline|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337070|NCT00787800|B1|Baseline|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337071|NCT00787800|P2|Participant Flow|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337072|NCT00787800|P1|Participant Flow|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337073|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337074|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337075|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337076|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337077|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337078|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337079|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337080|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337081|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337082|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337083|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337084|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337085|NCT00787800|E2|Reported Event|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
337086|NCT00787800|E1|Reported Event|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
337087|NCT00787761|B1|Baseline|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337088|NCT00787761|P1|Participant Flow|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337089|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337090|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337091|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337092|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337137|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337093|NCT00787761|O1|Outcome|Severe Graft Versus Host Disease|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
337094|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337095|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337096|NCT00787761|O1|Outcome|Transplant Recipients|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
337097|NCT00787761|E1|Reported Event|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
337098|NCT00789321|B3|Baseline|Total|Total of all reporting groups
337099|NCT00789321|B2|Baseline|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
337100|NCT00789321|B1|Baseline|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
337101|NCT00789321|P2|Participant Flow|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
337102|NCT00789321|P1|Participant Flow|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
337103|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
337104|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
337105|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
337106|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
337107|NCT00789321|E2|Reported Event|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
337108|NCT00789321|E1|Reported Event|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
337109|NCT00789256|B3|Baseline|Total|Total of all reporting groups
337110|NCT00789256|B2|Baseline|Strata 2|will include patients who have received prior medical intervention for their disease.
337111|NCT00789256|B1|Baseline|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
337112|NCT00789256|P2|Participant Flow|Strata 2|will include patients who have received prior medical intervention for their disease.
337113|NCT00789256|P1|Participant Flow|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
337114|NCT00789256|O2|Outcome|Strata 2|will include patients who have received prior medical intervention for their disease.
337115|NCT00789256|O1|Outcome|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
337116|NCT00789256|E2|Reported Event|Strata 2|will include patients who have received prior medical intervention for their disease.
337117|NCT00789256|E1|Reported Event|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
337118|NCT00789191|B3|Baseline|Total|Total of all reporting groups
337119|NCT00789191|B2|Baseline|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337120|NCT00789191|B1|Baseline|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337121|NCT00789191|P2|Participant Flow|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337122|NCT00789191|P1|Participant Flow|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337123|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337124|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337125|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337126|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337127|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337128|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337129|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337130|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337131|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337132|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337133|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337134|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337135|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337136|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337138|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337139|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337140|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337141|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337142|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337143|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337144|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337145|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337146|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337147|NCT00789191|E2|Reported Event|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
337148|NCT00789191|E1|Reported Event|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
337149|NCT00789113|B1|Baseline|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
337150|NCT00789113|P1|Participant Flow|Extended Release Lamotrigine|"Extended Release Lamotrigine~Extended Release Lamotrigine"
337151|NCT00789113|O2|Outcome|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
337152|NCT00789113|O1|Outcome|Immediate Release (IR) Lamotrigine|Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
337153|NCT00789113|E1|Reported Event|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
337154|NCT00789074|B3|Baseline|Total|Total of all reporting groups
337155|NCT00789074|B2|Baseline|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
337156|NCT00789074|B1|Baseline|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
337157|NCT00789074|P2|Participant Flow|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
337158|NCT00789074|P1|Participant Flow|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
337159|NCT00789074|O2|Outcome|Placebo|
337160|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
337161|NCT00789074|O2|Outcome|Placebo|
337162|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
337163|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
337164|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
337165|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
337166|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
337167|NCT00789074|O2|Outcome|Placebo|
337168|NCT00789074|O1|Outcome|Varenicline|
337169|NCT00789074|O2|Outcome|Placebo|
337170|NCT00789074|O1|Outcome|Varenicline|
337171|NCT00789074|E2|Reported Event|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
337172|NCT00789074|E1|Reported Event|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
337173|NCT00789035|B6|Baseline|Total|Total of all reporting groups
337174|NCT00789035|B5|Baseline|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337175|NCT00789035|B4|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337176|NCT00789035|B3|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337177|NCT00789035|B2|Baseline|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337178|NCT00789035|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337179|NCT00789035|P5|Participant Flow|Metformin OL|Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337180|NCT00789035|P4|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337181|NCT00789035|P3|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337182|NCT00789035|P2|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337183|NCT00789035|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337184|NCT00789035|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337185|NCT00789035|O2|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337186|NCT00789035|O1|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337229|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337230|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337187|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337188|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337189|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337190|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337191|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337192|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337193|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337194|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337195|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337196|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337197|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337198|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337199|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337200|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337201|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337202|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337203|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337204|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337205|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337206|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337207|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337208|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337209|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337210|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337211|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337212|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337213|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337214|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337215|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337216|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337217|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337218|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337219|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337220|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337221|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337222|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337223|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337224|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
337225|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337226|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337227|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337228|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
337231|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337232|NCT00789035|E5|Reported Event|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
337233|NCT00789035|E4|Reported Event|Empagliflozin 25 mg qd|Patients receive 25 mg Empagliflozin in tablets once daily.
337234|NCT00789035|E3|Reported Event|Empagliflozin 10 mg qd|Patients receive 10 mg Empagliflozin in tablets once daily.
337235|NCT00789035|E2|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
337236|NCT00789035|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
337237|NCT00788957|B5|Baseline|Total|Total of all reporting groups
337238|NCT00788957|B4|Baseline|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337239|NCT00788957|B3|Baseline|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337240|NCT00788957|B2|Baseline|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337241|NCT00788957|B1|Baseline|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337242|NCT00788957|P6|Participant Flow|Part 3: Ganitumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
337243|NCT00788957|P5|Participant Flow|Part 3: Rilotumumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
337244|NCT00788957|P4|Participant Flow|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337245|NCT00788957|P3|Participant Flow|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337246|NCT00788957|P2|Participant Flow|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337247|NCT00788957|P1|Participant Flow|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337248|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337249|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337250|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337251|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337252|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337253|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337254|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337255|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337256|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337257|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337258|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337259|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337260|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337261|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337262|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337263|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337264|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337265|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337266|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337267|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337268|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337269|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337270|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337271|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337272|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337273|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337274|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337275|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337276|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337277|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337278|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337279|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337280|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337281|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337282|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337283|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337284|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337285|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337286|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337287|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337288|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337370|NCT00787618|O2|Outcome|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
337289|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337290|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337291|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337292|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337293|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337294|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337295|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337296|NCT00788957|E4|Reported Event|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337297|NCT00788957|E3|Reported Event|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337298|NCT00788957|E2|Reported Event|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337299|NCT00788957|E1|Reported Event|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
337300|NCT00788775|B3|Baseline|Total|Total of all reporting groups
337301|NCT00788775|B2|Baseline|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337302|NCT00788775|B1|Baseline|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337303|NCT00788775|P2|Participant Flow|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337304|NCT00788775|P1|Participant Flow|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337305|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337306|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337307|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337308|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337309|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337310|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337311|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337312|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337313|NCT00788775|E2|Reported Event|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337968|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337314|NCT00788775|E1|Reported Event|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
337315|NCT00788710|B4|Baseline|Total|Total of all reporting groups
337316|NCT00788710|B3|Baseline|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337317|NCT00788710|B2|Baseline|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337318|NCT00788710|B1|Baseline|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337319|NCT00788710|P3|Participant Flow|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337320|NCT00788710|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337321|NCT00788710|P1|Participant Flow|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337322|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337323|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337324|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337325|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337326|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337327|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337328|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337329|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337330|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337331|NCT00788710|E3|Reported Event|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
337332|NCT00788710|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
337333|NCT00788710|E1|Reported Event|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
337334|NCT00788593|B1|Baseline|Entire Study Population|Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
337335|NCT00788593|P3|Participant Flow|EUR-1008 (APT-1008) Low Dose, Then High Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
337336|NCT00788593|P2|Participant Flow|EUR-1008 (APT-1008) High Dose, Then Low Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
337337|NCT00788593|P1|Participant Flow|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
337338|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337339|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337340|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337341|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337371|NCT00787618|O1|Outcome|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
337969|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337342|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337343|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337344|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
337345|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337346|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337347|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
337348|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337349|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337350|NCT00788593|E3|Reported Event|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337351|NCT00788593|E2|Reported Event|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
337352|NCT00788593|E1|Reported Event|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
337353|NCT00787644|B3|Baseline|Total|Total of all reporting groups
337354|NCT00787644|B2|Baseline|2. Placebo|Placebo: Matching placebo (inert tablet)
337355|NCT00787644|B1|Baseline|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
337356|NCT00787644|P2|Participant Flow|2. Placebo|Placebo: Matching placebo (inert tablet)
337357|NCT00787644|P1|Participant Flow|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
337358|NCT00787644|O2|Outcome|2. Placebo|Placebo: Matching placebo (inert tablet)
337359|NCT00787644|O1|Outcome|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
337360|NCT00787644|E2|Reported Event|2. Placebo|Placebo: Matching placebo (inert tablet)
337361|NCT00787644|E1|Reported Event|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
337362|NCT00787618|B4|Baseline|Total|Total of all reporting groups
337363|NCT00787618|B3|Baseline|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
337364|NCT00787618|B2|Baseline|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
337365|NCT00787618|B1|Baseline|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
337366|NCT00787618|P3|Participant Flow|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
337367|NCT00787618|P2|Participant Flow|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
337368|NCT00787618|P1|Participant Flow|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
337369|NCT00787618|O3|Outcome|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
337970|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337372|NCT00787618|E3|Reported Event|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
337373|NCT00787618|E2|Reported Event|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
337374|NCT00787618|E1|Reported Event|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
337375|NCT00787605|B3|Baseline|Total|Total of all reporting groups
337376|NCT00787605|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337377|NCT00787605|B1|Baseline|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337378|NCT00787605|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337379|NCT00787605|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337380|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337381|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337382|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337383|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337384|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337385|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337386|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337387|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337388|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337389|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337390|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337391|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337392|NCT00787605|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
337393|NCT00787605|E1|Reported Event|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
337394|NCT00788372|B1|Baseline|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337395|NCT00788372|P1|Participant Flow|Fentanyl|Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337396|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337397|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337398|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337399|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337400|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337401|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337402|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337403|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337446|NCT00787943|O1|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
337404|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337405|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337406|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337407|NCT00788372|E1|Reported Event|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
337408|NCT00788255|B1|Baseline|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337409|NCT00788255|P1|Participant Flow|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337410|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337411|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337412|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337413|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337414|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337709|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337415|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337416|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
337417|NCT00788255|E4|Reported Event|0 μU/mL Exogenous Oxytocin|Thromboelastography on native blood sample.
337418|NCT00788255|E3|Reported Event|32.9 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
337419|NCT00788255|E2|Reported Event|30.1 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
337420|NCT00788255|E1|Reported Event|22.5 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
337421|NCT00788073|B3|Baseline|Total|Total of all reporting groups
337422|NCT00788073|B2|Baseline|Placebo|placebo variable dose (same flexible dose titration protocol) bid to tid, oral, 4weeks
337423|NCT00788073|B1|Baseline|STX209|STX209 Variable dose, 1mg bid to 10mg tid, oral capsules, 4weeks
337424|NCT00788073|P2|Participant Flow|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337425|NCT00788073|P1|Participant Flow|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337426|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337427|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337428|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337429|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
337430|NCT00788073|E2|Reported Event|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
337431|NCT00788073|E1|Reported Event|STX209|STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
337432|NCT00788008|B3|Baseline|Total|Total of all reporting groups
337433|NCT00788008|B2|Baseline|Propofol|Total intravenous anesthesia with propofol
337434|NCT00788008|B1|Baseline|Isoflurane|Inhalational anesthesia with isoflurane
337435|NCT00788008|P2|Participant Flow|Propofol|Total intravenous anesthesia with propofol
337436|NCT00788008|P1|Participant Flow|Isoflurane|Inhalational anesthesia with isoflurane
337437|NCT00788008|O2|Outcome|Propofol|Total intravenous anesthesia with propofol
337438|NCT00788008|O1|Outcome|Isoflurane|Inhalational anesthesia with isoflurane
337439|NCT00788008|E2|Reported Event|Propofol|Total intravenous anesthesia with propofol
337440|NCT00788008|E1|Reported Event|Isoflurane|Inhalational anesthesia with isoflurane
337441|NCT00787943|B1|Baseline|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
337442|NCT00787943|P1|Participant Flow|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
337443|NCT00787943|O4|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
337444|NCT00787943|O3|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
337445|NCT00787943|O2|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
337710|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337447|NCT00787943|E2|Reported Event|Benzoyl Peroxide 10.0% Cream: Formulation #2|Formulation #2 applied to one side of the face by all 10 subjects.
337448|NCT00787943|E1|Reported Event|Benzoyl Peroxide 10.0% Cream Formulation #1|Formulation #1 applied to one side of the face by all 10 subjects.
337449|NCT00787930|B1|Baseline|Naturalistic Treatment|
337450|NCT00787930|P1|Participant Flow|Naturalistic Treatment|Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines.
337451|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
337452|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
337453|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) <15 or Montgomery Asberg Depression Rating Scale (MADRS) scales <15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
337454|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
337455|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
337456|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
337457|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
337458|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
337459|NCT00787930|O2|Outcome|Non-Responders to Acute Treatment|Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3.
337460|NCT00787930|O1|Outcome|Responders to Acute Treatment|Subjects in an acute manic episode who responded to treatment as measured by a Young Mania Rating Scale (YMRS) <15 by week 3, which was the protocol-defined determination point for response to treatment.
337461|NCT00787930|E1|Reported Event|Naturalistic Treatment|Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated.
337462|NCT00787917|B3|Baseline|Total|Total of all reporting groups
337463|NCT00787917|B2|Baseline|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337464|NCT00787917|B1|Baseline|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337465|NCT00787917|P2|Participant Flow|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337466|NCT00787917|P1|Participant Flow|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337467|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337468|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337469|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337470|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337471|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337472|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337473|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337474|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
337475|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337476|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
337477|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337478|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
337479|NCT00787917|E3|Reported Event|Open Label Omalizumab|Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
337711|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337480|NCT00787917|E2|Reported Event|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
337481|NCT00787917|E1|Reported Event|Blinded Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
337482|NCT00787904|B3|Baseline|Total|Total of all reporting groups
337483|NCT00787904|B2|Baseline|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
337484|NCT00787904|B1|Baseline|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
337485|NCT00787904|P2|Participant Flow|Surgical Control|Pre-menopausal women with or without surgery
337486|NCT00787904|P1|Participant Flow|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
337487|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
337488|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
337489|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
337490|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
337491|NCT00787904|E2|Reported Event|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
337492|NCT00787904|E1|Reported Event|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
337493|NCT00787891|B3|Baseline|Total|Total of all reporting groups
337494|NCT00787891|B2|Baseline|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337495|NCT00787891|B1|Baseline|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337496|NCT00787891|P2|Participant Flow|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337497|NCT00787891|P1|Participant Flow|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337498|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337499|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337500|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337501|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337502|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337503|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337504|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337505|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337506|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337507|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337508|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337509|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337510|NCT00787891|E4|Reported Event|Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337511|NCT00787891|E3|Reported Event|Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337512|NCT00787891|E2|Reported Event|Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337513|NCT00787891|E1|Reported Event|Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
337514|NCT00787566|B4|Baseline|Total|Total of all reporting groups
337515|NCT00787566|B3|Baseline|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
337516|NCT00787566|B2|Baseline|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
337517|NCT00787566|B1|Baseline|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
337518|NCT00787566|P3|Participant Flow|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
337519|NCT00787566|P2|Participant Flow|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
337520|NCT00787566|P1|Participant Flow|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
337521|NCT00787566|O3|Outcome|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
337522|NCT00787566|O2|Outcome|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
337523|NCT00787566|O1|Outcome|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
337524|NCT00787566|E3|Reported Event|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
337525|NCT00787566|E2|Reported Event|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
337526|NCT00787566|E1|Reported Event|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
337527|NCT00787527|B1|Baseline|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337528|NCT00787527|P1|Participant Flow|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle~Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.~Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337529|NCT00787527|O1|Outcome|Schedule B - Vorinostat Three Times Daily|"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337530|NCT00787527|O2|Outcome|Schedule A - Vorinostat Twice Daily|"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337531|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337532|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once or Twice Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
337533|NCT00787527|E2|Reported Event|Schedule B: Vorinostat Three Times Daily|"Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
337534|NCT00787527|E1|Reported Event|Schedule A: Vorinostat Once or Twice Daily|"Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
337535|NCT00787332|B3|Baseline|Total|Total of all reporting groups
337536|NCT00787332|B2|Baseline|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
337537|NCT00787332|B1|Baseline|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
337538|NCT00787332|P2|Participant Flow|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
337539|NCT00787332|P1|Participant Flow|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
337540|NCT00787332|O2|Outcome|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
337541|NCT00787332|O1|Outcome|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
337542|NCT00787332|E2|Reported Event|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
337543|NCT00787332|E1|Reported Event|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
337544|NCT00787319|B1|Baseline|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337545|NCT00787319|P1|Participant Flow|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337546|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337547|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337548|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337712|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337549|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337550|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337551|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337552|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337553|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337554|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337555|NCT00787319|E1|Reported Event|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
337556|NCT00787267|B1|Baseline|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337557|NCT00787267|P1|Participant Flow|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337558|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337559|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337560|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337561|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337562|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337563|NCT00787267|E1|Reported Event|Evalulable Patients That Received Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
337564|NCT00787254|B3|Baseline|Total|Total of all reporting groups
337565|NCT00787254|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337566|NCT00787254|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337567|NCT00787254|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337568|NCT00787254|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337569|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337570|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337571|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337572|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337573|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337574|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337575|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337576|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337577|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337578|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337579|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337580|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337581|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337582|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337583|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337584|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337585|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337586|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337587|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337588|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337589|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337590|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337591|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337592|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337593|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337594|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337595|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337596|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337597|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337598|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337599|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337600|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337601|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337602|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337603|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337604|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337605|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337606|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337607|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337608|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337609|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337610|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337611|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337612|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337613|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337614|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337615|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337616|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337617|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337618|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337619|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337620|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337621|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337622|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337623|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337624|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337625|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337626|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337627|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337628|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337629|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337630|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337631|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337632|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337633|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337634|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337635|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337636|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337637|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337638|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337639|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337640|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337641|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337642|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337643|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337644|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337645|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337646|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337647|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337648|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337649|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337650|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337651|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337652|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337653|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337654|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337655|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337656|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337657|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337658|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337659|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337660|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337661|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337662|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337663|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337664|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337665|NCT00787254|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
337666|NCT00787254|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
337667|NCT00787241|B4|Baseline|Total|Total of all reporting groups
337668|NCT00787241|B3|Baseline|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
337669|NCT00787241|B2|Baseline|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
337670|NCT00787241|B1|Baseline|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337671|NCT00787241|P3|Participant Flow|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
337672|NCT00787241|P2|Participant Flow|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
337673|NCT00787241|P1|Participant Flow|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337674|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
337675|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
337676|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337677|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
337678|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
337679|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337680|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
337681|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
337682|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337683|NCT00787241|E3|Reported Event|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
337684|NCT00787241|E2|Reported Event|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
337685|NCT00787241|E1|Reported Event|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
337686|NCT00787202|B6|Baseline|Total|Total of all reporting groups
337687|NCT00787202|B5|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337688|NCT00787202|B4|Baseline|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337689|NCT00787202|B3|Baseline|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337690|NCT00787202|B2|Baseline|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337691|NCT00787202|B1|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337692|NCT00787202|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337693|NCT00787202|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337694|NCT00787202|P3|Participant Flow|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337695|NCT00787202|P2|Participant Flow|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
337696|NCT00787202|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337697|NCT00787202|O4|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337698|NCT00787202|O3|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337699|NCT00787202|O2|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337700|NCT00787202|O1|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337701|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337702|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337703|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337704|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337705|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337706|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337707|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337708|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337960|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337713|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337714|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337715|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337716|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337717|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337718|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337719|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337720|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337721|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337722|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337723|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337724|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337725|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337726|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337727|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337728|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337729|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337730|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337731|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337732|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337733|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337734|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337735|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337736|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337737|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337738|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337739|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337740|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337741|NCT00787202|E5|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
337742|NCT00787202|E4|Reported Event|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
337743|NCT00787202|E3|Reported Event|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
337744|NCT00787202|E2|Reported Event|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
337745|NCT00787202|E1|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
337746|NCT00787189|B3|Baseline|Total|Total of all reporting groups
337747|NCT00787189|B2|Baseline|Control|Placebo laser device
337748|NCT00787189|B1|Baseline|Active|Active laser device
337749|NCT00787189|P2|Participant Flow|Control|Placebo laser device
337750|NCT00787189|P1|Participant Flow|Active|Active laser device
337751|NCT00787189|O2|Outcome|Control|Placebo laser device
337752|NCT00787189|O1|Outcome|Active|Active laser device
337753|NCT00787189|E2|Reported Event|Control|Placebo laser device
337754|NCT00787189|E1|Reported Event|Active|Active laser device
337755|NCT00787150|B4|Baseline|Total|Total of all reporting groups
337756|NCT00787150|B3|Baseline|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337757|NCT00787150|B2|Baseline|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337758|NCT00787150|B1|Baseline|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337759|NCT00787150|P3|Participant Flow|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337760|NCT00787150|P2|Participant Flow|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337761|NCT00787150|P1|Participant Flow|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337762|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337763|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337961|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337764|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337765|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337766|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337767|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337768|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337769|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337770|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337771|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337772|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337773|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337774|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337775|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337776|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337777|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337778|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337779|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337780|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337781|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337782|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337783|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337784|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337785|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337786|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337787|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337788|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337789|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337790|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337791|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337792|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337793|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337794|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337962|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337963|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337795|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337796|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337797|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337798|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337799|NCT00787150|E3|Reported Event|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337800|NCT00787150|E2|Reported Event|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
337801|NCT00787150|E1|Reported Event|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
337802|NCT00787137|B4|Baseline|Total|Total of all reporting groups
337803|NCT00787137|B3|Baseline|Placebo|Control, phosphate-buffered saline
337804|NCT00787137|B2|Baseline|PG102 1 mg/kg|Second dose PG102
337805|NCT00787137|B1|Baseline|PG102 0.3 mg/kg|Lowest dose PG102
337806|NCT00787137|P3|Participant Flow|Placebo|Control, phosphate-buffered saline
337807|NCT00787137|P2|Participant Flow|PG102 1 mg/kg|Second dose PG102
337808|NCT00787137|P1|Participant Flow|PG102 0.3 mg/kg|Lowest dose PG102
337809|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
337810|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
337811|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
337812|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
337813|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
337814|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
337815|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
337816|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
337817|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
337818|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
337819|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
337820|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
337821|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
337822|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
337823|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
337824|NCT00787137|E3|Reported Event|Placebo|Control, phosphate-buffered saline
337825|NCT00787137|E2|Reported Event|PG102 1 mg/kg|Second dose PG102
337826|NCT00787137|E1|Reported Event|PG102 0.3 mg/kg|Lowest dose PG102
337827|NCT00787124|B3|Baseline|Total|Total of all reporting groups
337828|NCT00787124|B2|Baseline|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
337829|NCT00787124|B1|Baseline|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
337830|NCT00787124|P2|Participant Flow|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
337831|NCT00787124|P1|Participant Flow|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
337832|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
337833|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
337834|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
337835|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
337836|NCT00787124|E2|Reported Event|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
337837|NCT00787124|E1|Reported Event|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
337838|NCT00787020|B3|Baseline|Total|Total of all reporting groups
337839|NCT00787020|B2|Baseline|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337840|NCT00787020|B1|Baseline|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337841|NCT00787020|P2|Participant Flow|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337842|NCT00787020|P1|Participant Flow|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337843|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337844|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337845|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337846|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337847|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337848|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337849|NCT00787020|E2|Reported Event|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
337850|NCT00787020|E1|Reported Event|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
337851|NCT00786994|B5|Baseline|Total|Total of all reporting groups
337852|NCT00786994|B4|Baseline|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
337853|NCT00786994|B3|Baseline|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
337854|NCT00786994|B2|Baseline|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
337855|NCT00786994|B1|Baseline|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
337856|NCT00786994|P4|Participant Flow|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
337857|NCT00786994|P3|Participant Flow|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
337858|NCT00786994|P2|Participant Flow|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
337859|NCT00786994|P1|Participant Flow|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
337860|NCT00786994|O3|Outcome|C/D - Placebo Once or Twice Daily|"Placebo (petroleum jelly) for three months once or twice a day~Placebo (petroleum jelly)"
337861|NCT00786994|O2|Outcome|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
337862|NCT00786994|O1|Outcome|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
337863|NCT00786994|E4|Reported Event|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day~Placebo (petroleum jelly)"
337864|NCT00786994|E3|Reported Event|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day~Placebo (petroleum jelly)"
337865|NCT00786994|E2|Reported Event|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
337866|NCT00786994|E1|Reported Event|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
337867|NCT00786916|B4|Baseline|Total|Total of all reporting groups
337868|NCT00786916|B3|Baseline|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337869|NCT00786916|B2|Baseline|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337870|NCT00786916|B1|Baseline|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337871|NCT00786916|P3|Participant Flow|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337872|NCT00786916|P2|Participant Flow|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337873|NCT00786916|P1|Participant Flow|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337964|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337965|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337874|NCT00786916|O3|Outcome|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337875|NCT00786916|O2|Outcome|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337876|NCT00786916|O1|Outcome|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
337877|NCT00786916|E3|Reported Event|Group C|0.50 mg/kg Lidocaine Group
337878|NCT00786916|E2|Reported Event|Group B|0.25 mg/kg Lidocaine Group
337879|NCT00786916|E1|Reported Event|Group A|Placebo (Saline) Group
337880|NCT00786864|B3|Baseline|Total|Total of all reporting groups
337881|NCT00786864|B2|Baseline|Control Group|Control group - no intervention
337882|NCT00786864|B1|Baseline|Exercise Intervention Group|Experimental Group
337883|NCT00786864|P2|Participant Flow|Control Group|Control group - no intervention
337884|NCT00786864|P1|Participant Flow|Exercise Intervention Group|Experimental Group
337885|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
337886|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
337887|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
337888|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
337889|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
337890|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
337891|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
337892|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
337893|NCT00786864|E2|Reported Event|Control Group|Control group - no intervention
337894|NCT00786864|E1|Reported Event|Exercise Intervention Group|Experimental Group
337895|NCT00786838|B1|Baseline|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337896|NCT00786838|P1|Participant Flow|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337897|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
337898|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1.
337899|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337900|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337901|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337902|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337903|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337904|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337905|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337906|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337907|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337908|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337909|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337910|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337911|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337912|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337913|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337914|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
337915|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337916|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337917|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
337918|NCT00786838|O1|Outcome|Placebo|Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
337919|NCT00786838|E1|Reported Event|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
337920|NCT00786799|B3|Baseline|Total|Total of all reporting groups
337921|NCT00786799|B2|Baseline|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
337966|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337967|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337922|NCT00786799|B1|Baseline|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
337923|NCT00786799|P2|Participant Flow|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
337924|NCT00786799|P1|Participant Flow|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
337925|NCT00786799|O2|Outcome|Placebo Group: Change in TNFα|
337926|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in TNFα|
337927|NCT00786799|O2|Outcome|Placebo Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
337928|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
337929|NCT00786799|O3|Outcome|Comparison Between Omega-3 and Placebo Groups|Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
337930|NCT00786799|O2|Outcome|Placebo|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
337931|NCT00786799|O1|Outcome|Active Omega-3|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
337932|NCT00786799|E2|Reported Event|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
337933|NCT00786799|E1|Reported Event|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
337934|NCT00786682|B1|Baseline|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337935|NCT00786682|P1|Participant Flow|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337936|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337937|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337938|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337939|NCT00786682|E1|Reported Event|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
337940|NCT00786643|B3|Baseline|Total|Total of all reporting groups
337941|NCT00786643|B2|Baseline|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337942|NCT00786643|B1|Baseline|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337943|NCT00786643|P2|Participant Flow|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337944|NCT00786643|P1|Participant Flow|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337945|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337946|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337947|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337948|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337949|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337950|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337951|NCT00786643|E2|Reported Event|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
337952|NCT00786643|E1|Reported Event|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
337953|NCT00786565|B1|Baseline|Akreos Intraocular Lens|
337954|NCT00786565|P1|Participant Flow|Akreos Intraocular Lens|Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
337955|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337956|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337957|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337958|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337959|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337972|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337973|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337974|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337975|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337976|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337977|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337978|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337979|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337980|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337981|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337982|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337983|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337984|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337985|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337986|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337987|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
337988|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
337989|NCT00786565|E2|Reported Event|Akreos Adapt Intraocular Lens|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
337990|NCT00786565|E1|Reported Event|Akreos Advanced Intraocular Lenses|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
337991|NCT00786487|B5|Baseline|Total|Total of all reporting groups
337992|NCT00786487|B4|Baseline|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
337993|NCT00786487|B3|Baseline|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
337994|NCT00786487|B2|Baseline|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
337995|NCT00786487|B1|Baseline|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
337996|NCT00786487|P4|Participant Flow|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
337997|NCT00786487|P3|Participant Flow|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
337998|NCT00786487|P2|Participant Flow|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
337999|NCT00786487|P1|Participant Flow|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
338000|NCT00786487|O4|Outcome|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
338001|NCT00786487|O3|Outcome|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
338002|NCT00786487|O2|Outcome|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
338003|NCT00786487|O1|Outcome|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
338004|NCT00786487|E4|Reported Event|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
338005|NCT00786487|E3|Reported Event|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
338006|NCT00786487|E2|Reported Event|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
338007|NCT00786487|E1|Reported Event|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
338008|NCT00786474|B3|Baseline|Total|Total of all reporting groups
338009|NCT00786474|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338010|NCT00786474|B1|Baseline|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338011|NCT00786474|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338012|NCT00786474|P1|Participant Flow|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338013|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338014|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338015|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338016|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338017|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338018|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338019|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338020|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338021|NCT00786474|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
338022|NCT00786474|E1|Reported Event|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
338151|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338023|NCT00786422|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338024|NCT00786422|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338025|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338026|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338027|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338028|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338029|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338030|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
338031|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
338032|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
338033|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
338034|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
338035|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
338036|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338037|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338038|NCT00786422|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
338039|NCT00786188|B3|Baseline|Total|Total of all reporting groups
338040|NCT00786188|B2|Baseline|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
338041|NCT00786188|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
338042|NCT00786188|P2|Participant Flow|Placebo - Sugar Pill|"Interventions Administered:~Subjects received placebo capsules administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."
338043|NCT00786188|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Interventions Administered:~Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."
338044|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338045|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338046|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338047|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338048|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338049|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338050|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338051|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338052|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338053|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338054|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338152|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338055|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338056|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338057|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338058|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338059|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338060|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338061|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
338062|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338063|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338064|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
338065|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.~Subjects will be randomized to one of the two treatments in a 1:1 ratio"
338066|NCT00786188|E2|Reported Event|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
338067|NCT00786188|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
338068|NCT00786032|B1|Baseline|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338069|NCT00786032|P1|Participant Flow|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338070|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338071|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338072|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338073|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338074|NCT00786032|O1|Outcome|BCI Device - Time Assisting Patient With Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. The time was measured of how long the the caregiver assisted the patient with the device."
338075|NCT00786032|O1|Outcome|BCI Device|"The McGill Quality of Life (MQOL) is a 16 item scale that has five distinct sub-measures: physical well-being; physical symptoms; psychological symptoms; existential well-being; support. These sub-measures are averaged to give a MQOL total score.~The range of total score is from 0 (worst) to 10 (best)."
338076|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338077|NCT00786032|E1|Reported Event|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
338078|NCT00785980|B1|Baseline|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
338149|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338079|NCT00785980|P1|Participant Flow|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
338080|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
338081|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
338082|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
338083|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
338084|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
338085|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
338086|NCT00785980|E3|Reported Event|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
338087|NCT00785980|E2|Reported Event|Ciprofloxacin Alone|Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
338088|NCT00785980|E1|Reported Event|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
338089|NCT00785798|B1|Baseline|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
338090|NCT00785798|P1|Participant Flow|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
338091|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
338092|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
338093|NCT00785798|E1|Reported Event|Vorinostat Doxil|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Vorinostat: 200mg to 400 mg twice daily on days 1-7~Pegylated Liposomal Doxorubicin (PLD), Doxil: IV 30mg/m2 on day 3 of a 21-day cycle"
338094|NCT00785785|B3|Baseline|Total|Total of all reporting groups
338095|NCT00785785|B2|Baseline|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
338096|NCT00785785|B1|Baseline|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
338097|NCT00785785|P2|Participant Flow|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
338098|NCT00785785|P1|Participant Flow|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
338099|NCT00785785|O2|Outcome|Imatinib|imatinib 400 mg once daily
338100|NCT00785785|O1|Outcome|Nilotinib|nilotinib 400 mg twice a day
338101|NCT00785785|E4|Reported Event|Crossover Imatinib|exposure to nilotinib and then imatinib
338102|NCT00785785|E3|Reported Event|Crossover Nilotinib|exposure to imatinib and then nilotinib
338103|NCT00785785|E2|Reported Event|Imatinib|Exposure to Imatinib only
338104|NCT00785785|E1|Reported Event|Nilotinib|Exposure to Nilotinib only
338105|NCT00785772|B1|Baseline|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338106|NCT00785772|P1|Participant Flow|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338150|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338107|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338108|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338109|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338110|NCT00785772|E1|Reported Event|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
338111|NCT00785629|B5|Baseline|Total|Total of all reporting groups
338112|NCT00785629|B4|Baseline|Placebo|
338113|NCT00785629|B3|Baseline|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
338114|NCT00785629|B2|Baseline|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
338115|NCT00785629|B1|Baseline|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
338116|NCT00785629|P4|Participant Flow|Placebo|
338117|NCT00785629|P3|Participant Flow|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
338118|NCT00785629|P2|Participant Flow|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
338119|NCT00785629|P1|Participant Flow|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
338120|NCT00785629|O2|Outcome|All Placebo Treated Patients|All placebo treated patients
338121|NCT00785629|O1|Outcome|All Active Treated Patients|All actively treated patients
338122|NCT00785629|E4|Reported Event|Calcium Acetate|
338123|NCT00785629|E3|Reported Event|Sevelamer Carbonate|
338124|NCT00785629|E2|Reported Event|Lanthanum Carbonate|
338125|NCT00785629|E1|Reported Event|Placebo|
338126|NCT00785577|B6|Baseline|Total|Total of all reporting groups
338127|NCT00785577|B5|Baseline|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338128|NCT00785577|B4|Baseline|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338129|NCT00785577|B3|Baseline|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338130|NCT00785577|B2|Baseline|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338131|NCT00785577|B1|Baseline|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338132|NCT00785577|P5|Participant Flow|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338133|NCT00785577|P4|Participant Flow|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338134|NCT00785577|P3|Participant Flow|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338135|NCT00785577|P2|Participant Flow|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338136|NCT00785577|P1|Participant Flow|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338137|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338138|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338139|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338140|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338141|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338142|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338143|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338144|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338145|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338146|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338147|NCT00785577|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
338148|NCT00785577|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
338153|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338154|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338155|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338156|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338157|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338158|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338159|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338160|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338161|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338162|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338163|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338164|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338165|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338166|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
338167|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338168|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338169|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338170|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338171|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338172|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338173|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338174|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338175|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338176|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338177|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338178|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338179|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338180|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338181|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338182|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338183|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338184|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338185|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338186|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338187|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338188|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338189|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338190|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338191|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338192|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338193|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338194|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338195|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338196|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338197|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338198|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338199|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338200|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338201|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338202|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338203|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338204|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338205|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338206|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338207|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338208|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338209|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338210|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338211|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338212|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338213|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338214|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338215|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338216|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338217|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338218|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338219|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338220|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338221|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338222|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338223|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338224|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338225|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338226|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338227|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338228|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338229|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338230|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338231|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338232|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338233|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338234|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338235|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338236|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338237|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338238|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338239|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338240|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338241|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338242|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338243|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338244|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338245|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
338246|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338247|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338248|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338249|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338250|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338251|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338252|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338253|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338254|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
338255|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
338256|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338257|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338258|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338259|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
338260|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
338261|NCT00785577|E10|Reported Event|Pregabalin Washout|A one-week washout period in which no pregabalin was taken.
338262|NCT00785577|E9|Reported Event|LY545694 105 mg Washout|A one-week washout period in which no LY545694 105 mg was taken.
338263|NCT00785577|E8|Reported Event|LY545694 49 mg Washout|A one-week washout period in which no LY545694 49 mg was taken.
338264|NCT00785577|E7|Reported Event|LY545694 21 mg Washout|A one-week washout period in which no LY545694 21 mg was taken.
338265|NCT00785577|E6|Reported Event|Placebo Washout|A one-week washout period in which no placebo was taken.
338266|NCT00785577|E5|Reported Event|Pregabalin|Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
338267|NCT00785577|E4|Reported Event|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
338268|NCT00785577|E3|Reported Event|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
338269|NCT00785577|E2|Reported Event|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
338270|NCT00785577|E1|Reported Event|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
338271|NCT00785512|B3|Baseline|Total|Total of all reporting groups
338272|NCT00785512|B2|Baseline|Placebo|Matching placebo tablets, oral administration
338273|NCT00785512|B1|Baseline|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
338274|NCT00785512|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
338275|NCT00785512|P1|Participant Flow|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
338276|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
338277|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
338278|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
338279|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
338280|NCT00785512|E3|Reported Event|Placebo|Matching placebo tablets, oral administration
338281|NCT00785512|E2|Reported Event|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
338282|NCT00785512|E1|Reported Event|Single-blind Nebivolol|Pre-randomization 12 week nebivolol treatment.
338283|NCT00785486|B1|Baseline|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
338284|NCT00785486|P1|Participant Flow|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
338285|NCT00785486|O2|Outcome|Qualaquin (Quinine) With Midazolam|On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
338286|NCT00785486|O1|Outcome|Qualaquin (Quinine) Alone|On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
338287|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
338288|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
338289|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
338290|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
338291|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
338292|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
338293|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method.
338294|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam
338295|NCT00785486|O6|Outcome|Quinine - Qualaquin (Quinine) With Midazolam|On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam.
338296|NCT00785486|O5|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state.
338297|NCT00785486|O4|Outcome|Midazolam - Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state.
338298|NCT00785486|O3|Outcome|Quinine - Qualaquin(Quinine) Alone|On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose.
338299|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam
338300|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam.
338301|NCT00785486|E3|Reported Event|Midazolam With Qualaquin (Quinine) Together|Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally.
338302|NCT00785486|E2|Reported Event|Qualaquin (Quinine) Alone|Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period.
338303|NCT00785486|E1|Reported Event|Midazolam Alone|Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
338304|NCT00785356|B4|Baseline|Total|Total of all reporting groups
338305|NCT00785356|B3|Baseline|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
338306|NCT00785356|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
338307|NCT00785356|B1|Baseline|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
338308|NCT00785356|P1|Participant Flow|All Groups|Proellex 25 mg, Proellex 50 mg, 1placebo
338309|NCT00785356|O3|Outcome|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
338310|NCT00785356|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
338311|NCT00785356|O1|Outcome|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
338312|NCT00785356|E3|Reported Event|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
338313|NCT00785356|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
338314|NCT00785356|E1|Reported Event|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
338315|NCT00785291|B4|Baseline|Total|Total of all reporting groups
338316|NCT00785291|B3|Baseline|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338317|NCT00785291|B2|Baseline|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338318|NCT00785291|B1|Baseline|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338319|NCT00785291|P3|Participant Flow|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338320|NCT00785291|P2|Participant Flow|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338321|NCT00785291|P1|Participant Flow|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338322|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338323|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338387|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338324|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338325|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338326|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338327|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338328|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338329|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338330|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338331|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338332|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338333|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338334|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338335|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338336|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338337|NCT00785291|E3|Reported Event|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
338338|NCT00785291|E2|Reported Event|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338339|NCT00785291|E1|Reported Event|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
338340|NCT00785213|B1|Baseline|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
338341|NCT00785213|P1|Participant Flow|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
338342|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
338343|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
338344|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
338345|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
338346|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
338347|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
338348|NCT00785213|E3|Reported Event|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
338388|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
340989|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
338349|NCT00785213|E2|Reported Event|Quinine Sulfate Alone|On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
338350|NCT00785213|E1|Reported Event|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
338351|NCT00784979|B1|Baseline|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
338352|NCT00784979|P1|Participant Flow|CMVIG Followed by PP|MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
338353|NCT00784979|O1|Outcome|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
338354|NCT00784979|E1|Reported Event|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
338355|NCT00784927|B1|Baseline|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1.~20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
338356|NCT00784927|P1|Participant Flow|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
338357|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
338358|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
338359|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
338360|NCT00784927|O1|Outcome|Treatment|"Participants with lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia) will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles and analyzed as a separate cohort:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.~rituximab~cyclophosphamide~dexamethasone~lenalidomide"
338361|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
338362|NCT00784927|E1|Reported Event|Treatment|40 mg Dexamethasone orally on days 1, 8, 15, 22.
338363|NCT00784875|B5|Baseline|Total|Total of all reporting groups
338364|NCT00784875|B4|Baseline|Placebo|Participants received placebo in Period B (2-week treatment period).
338365|NCT00784875|B3|Baseline|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338366|NCT00784875|B2|Baseline|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338367|NCT00784875|B1|Baseline|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338368|NCT00784875|P4|Participant Flow|Placebo|Participants received placebo in a 2-week treatment period.
338369|NCT00784875|P3|Participant Flow|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338370|NCT00784875|P2|Participant Flow|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338371|NCT00784875|P1|Participant Flow|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338372|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338373|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338374|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338375|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338376|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338377|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338378|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338379|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period
338380|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338381|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338382|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338383|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338384|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338385|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338386|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338389|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338390|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338391|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338392|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338393|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338394|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338395|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338396|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338397|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338398|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338399|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338400|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338401|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338402|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338403|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338404|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338405|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338406|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338407|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338408|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338409|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338410|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338411|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338412|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
338413|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
338414|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
338415|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
338416|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338417|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338418|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338419|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338420|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338421|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338422|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338423|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338424|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338425|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338426|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338427|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338428|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338429|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338430|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338431|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338432|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338433|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338434|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338435|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338436|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338437|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338438|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338439|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338440|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338441|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338442|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338443|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338444|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338445|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338446|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338447|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338448|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338449|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338450|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338451|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338452|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338453|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338454|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338455|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338456|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338457|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338458|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338459|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338460|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338461|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338462|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338463|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338464|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338465|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338466|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338467|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338468|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
338469|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338470|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
338471|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
338472|NCT00784875|E12|Reported Event|Period D - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
338473|NCT00784875|E11|Reported Event|Period D - Placebo|Patients received placebo in Period D (2-week treatment period).
338474|NCT00784875|E10|Reported Event|Period D - LY2624803 3 mg|Patients received LY2624803 3 mg in Period D (2-week treatment period).
338475|NCT00784875|E9|Reported Event|Period D - LY2624803 1 mg|Patients received LY2624803 1 mg in Period D (2-week treatment period.
338476|NCT00784875|E8|Reported Event|Period C - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
338477|NCT00784875|E7|Reported Event|Period C - Placebo|Patients received placebo in Period C (2-week treatment period).
338478|NCT00784875|E6|Reported Event|Period C - LY2624803 3 mg|Patients received LY2624803 3 mg in Period C (2-week treatment period).
338479|NCT00784875|E5|Reported Event|Period C - LY2624803 1 mg|Patients received LY2624803 1 mg in Period C (2-week treatment period.
338480|NCT00784875|E4|Reported Event|Period B - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
338481|NCT00784875|E3|Reported Event|Period B - Placebo|Patients received placebo in Period B (2-week treatment period).
338482|NCT00784875|E2|Reported Event|Period B - LY2624803 3 mg|Patients received LY2624803 3 mg in Period B (2-week treatment period).
338483|NCT00784875|E1|Reported Event|Period B - LY2624803 1 mg|Patients received LY2624803 1 mg in Period B (2-week treatment period.
338484|NCT00784849|B1|Baseline|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338485|NCT00784849|P1|Participant Flow|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338486|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338487|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338488|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338489|NCT00784849|E1|Reported Event|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
338490|NCT00784836|B1|Baseline|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
338491|NCT00784836|P1|Participant Flow|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
338492|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
338493|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
338494|NCT00784836|E1|Reported Event|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
338495|NCT00784810|B3|Baseline|Total|Total of all reporting groups
338496|NCT00784810|B2|Baseline|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
338497|NCT00784810|B1|Baseline|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
338498|NCT00784810|P2|Participant Flow|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
338499|NCT00784810|P1|Participant Flow|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
338500|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
338501|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
338502|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
338503|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
338504|NCT00784810|E2|Reported Event|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
338505|NCT00784810|E1|Reported Event|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
338506|NCT00784784|B3|Baseline|Total|Total of all reporting groups
338507|NCT00784784|B2|Baseline|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
338508|NCT00784784|B1|Baseline|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
338509|NCT00784784|P2|Participant Flow|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
338510|NCT00784784|P1|Participant Flow|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
338511|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
338512|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
338513|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
338514|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
338515|NCT00784784|E2|Reported Event|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
338516|NCT00784784|E1|Reported Event|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
338517|NCT00784719|B8|Baseline|Total|Total of all reporting groups
338518|NCT00784719|B7|Baseline|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338519|NCT00784719|B6|Baseline|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338520|NCT00784719|B5|Baseline|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338521|NCT00784719|B4|Baseline|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338522|NCT00784719|B3|Baseline|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338523|NCT00784719|B2|Baseline|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338524|NCT00784719|B1|Baseline|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338525|NCT00784719|P7|Participant Flow|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338526|NCT00784719|P6|Participant Flow|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338527|NCT00784719|P5|Participant Flow|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338528|NCT00784719|P4|Participant Flow|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338529|NCT00784719|P3|Participant Flow|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338530|NCT00784719|P2|Participant Flow|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338531|NCT00784719|P1|Participant Flow|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338532|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338533|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338534|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338535|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338536|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338537|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338538|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338539|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338540|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338541|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338542|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338543|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338544|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338545|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338776|NCT00784459|B1|Baseline|Placebo|Placebo : Treatment with Placebo, IV
338546|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338547|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338548|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338549|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338550|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338551|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338552|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338553|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338554|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338555|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338556|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338557|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338558|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338559|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338560|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338561|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338562|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338563|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338564|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338565|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338566|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338567|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338568|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338569|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338570|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338571|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338572|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338573|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338574|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338575|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338576|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338577|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338578|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338579|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338580|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338581|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338582|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338583|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338584|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338585|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338586|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338587|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338588|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338589|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338590|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338591|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338592|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338593|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338594|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338595|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338596|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338597|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338598|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338599|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338600|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338601|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338602|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338603|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338604|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338605|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338606|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338607|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338608|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338609|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338610|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338611|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338612|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338613|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338614|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338615|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338616|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338617|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338618|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338619|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338620|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338621|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338622|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338623|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338624|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338625|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338626|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338627|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338628|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338629|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338630|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338777|NCT00784459|P2|Participant Flow|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
338631|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338632|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338633|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338634|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338635|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338636|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338637|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338638|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338639|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338640|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338641|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338642|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338643|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338644|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338645|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338646|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338647|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338648|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338649|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338650|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338651|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338652|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338653|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338654|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338655|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338656|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338657|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338658|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338659|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338660|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338661|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338662|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338663|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338664|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338665|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338666|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338667|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338668|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338669|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338670|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338671|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338672|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338778|NCT00784459|P1|Participant Flow|Placebo|Placebo : Treatment with Placebo, IV
340990|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
338673|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338674|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338675|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338676|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338677|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338678|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338679|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338680|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338681|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338682|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338683|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338684|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338685|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338686|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338687|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338688|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338689|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338690|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338691|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338692|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338693|NCT00784719|E7|Reported Event|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
338694|NCT00784719|E6|Reported Event|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
338695|NCT00784719|E5|Reported Event|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
338696|NCT00784719|E4|Reported Event|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
338697|NCT00784719|E3|Reported Event|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
338698|NCT00784719|E2|Reported Event|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
338699|NCT00784719|E1|Reported Event|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
338700|NCT00784654|B1|Baseline|All Enrolled Subjects|
338701|NCT00784654|P3|Participant Flow|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338702|NCT00784654|P2|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338703|NCT00784654|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338704|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338705|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338706|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
338707|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338708|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338709|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338710|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338779|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
338711|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
338712|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338713|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338714|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338715|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338716|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338717|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
338718|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338719|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338720|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338721|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338722|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338723|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338724|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
338725|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338726|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338727|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
338728|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
338729|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
338730|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
338731|NCT00784654|E3|Reported Event|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.
338732|NCT00784654|E2|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.
338733|NCT00784654|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).
338734|NCT00784563|B4|Baseline|Total|Total of all reporting groups
338735|NCT00784563|B3|Baseline|Continuous-Year 3|Participants who were assigned to continuous training in the third year of the study without randomization. Due to potentially increased risk of knee pain without additional fitness benefits, we dropped the interval group for the third year.
338736|NCT00784563|B2|Baseline|Interval Training -Years 1 & 2|Participants who were randomized to interval training in the first 2 years of the study.
338737|NCT00784563|B1|Baseline|Continuous Training-Years 1 & 2|Participants who were randomized to continuous training in the first 2 years of the study.
338738|NCT00784563|P3|Participant Flow|Continuous Training - Year 3|Participant were assigned to continuous training without randomization.
338780|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
338781|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
338739|NCT00784563|P2|Participant Flow|Interval Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking.
338740|NCT00784563|P1|Participant Flow|Continuous Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
338741|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338742|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338743|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338744|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338745|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338746|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338747|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338748|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338749|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338750|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338751|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
338752|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
338753|NCT00784563|E2|Reported Event|Interval Training|This group consists of 22 subjects who were randomized to interval training in the first two years of the study. No subjects were assigned to the interval training in the third year of the study.
338754|NCT00784563|E1|Reported Event|Continuous Training|This group consists of 21 subjects who were randomized to continuous training in the first two years of the study and 17 subjects who were assigned to continuous training without randomization in the third year of the study. Thus, total group size is 38.
338755|NCT00784550|B3|Baseline|Total|Total of all reporting groups
338756|NCT00784550|B2|Baseline|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338757|NCT00784550|B1|Baseline|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338758|NCT00784550|P2|Participant Flow|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338759|NCT00784550|P1|Participant Flow|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338760|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338761|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338762|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338763|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338764|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338765|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338766|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338767|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338768|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338769|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338770|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338771|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338772|NCT00784550|E2|Reported Event|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
338773|NCT00784550|E1|Reported Event|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
338774|NCT00784459|B3|Baseline|Total|Total of all reporting groups
338775|NCT00784459|B2|Baseline|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
338783|NCT00784459|E2|Reported Event|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
338784|NCT00784459|E1|Reported Event|Placebo|Placebo : Treatment with Placebo, IV
338785|NCT00784368|B4|Baseline|Total|Total of all reporting groups
338786|NCT00784368|B3|Baseline|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338787|NCT00784368|B2|Baseline|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338788|NCT00784368|B1|Baseline|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338789|NCT00784368|P3|Participant Flow|FN (Switched Treatment)|Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338790|NCT00784368|P2|Participant Flow|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338791|NCT00784368|P1|Participant Flow|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338792|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338793|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338794|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338795|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338796|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338797|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338798|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338799|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338817|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338990|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
340991|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
338800|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338801|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338802|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338803|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338804|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338805|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338806|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338807|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338808|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338809|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338810|NCT00784368|O1|Outcome|SFI (JK1211 Monotherapy)|Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator’s discretion.
338811|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338812|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338813|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338814|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338815|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338816|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338818|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338819|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338820|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338821|NCT00784368|E3|Reported Event|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338822|NCT00784368|E2|Reported Event|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338823|NCT00784368|E1|Reported Event|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
338824|NCT00784277|B5|Baseline|Total|Total of all reporting groups
338825|NCT00784277|B4|Baseline|Oxycodone|IR Treatment : 10mg capsule for 14 days
338826|NCT00784277|B3|Baseline|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
338827|NCT00784277|B2|Baseline|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
338828|NCT00784277|B1|Baseline|Placebo|IR Treatment : 1 capsule for 14 days
338829|NCT00784277|P7|Participant Flow|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
338830|NCT00784277|P6|Participant Flow|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
338831|NCT00784277|P5|Participant Flow|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
338832|NCT00784277|P4|Participant Flow|Oxycodone|IR Treatment : 10mg for 14 days
338833|NCT00784277|P3|Participant Flow|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
338834|NCT00784277|P2|Participant Flow|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
338835|NCT00784277|P1|Participant Flow|Placebo|IR Treatment : 1 capsule for 14 days
338836|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
338837|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
338838|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
338839|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
338840|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
338841|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
338842|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
338843|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
338844|NCT00784277|E7|Reported Event|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
338845|NCT00784277|E6|Reported Event|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
338846|NCT00784277|E5|Reported Event|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
338847|NCT00784277|E4|Reported Event|Oxycodone|IR Treatment : 10mg for 14 days
338848|NCT00784277|E3|Reported Event|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
338849|NCT00784277|E2|Reported Event|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
338850|NCT00784277|E1|Reported Event|Placebo|IR Treatment : 1 capsule for 14 days
338851|NCT00784238|B1|Baseline|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
338852|NCT00784238|P1|Participant Flow|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
338853|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338854|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338855|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338856|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338991|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338857|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338858|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338859|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338860|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338861|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338862|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338863|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338864|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338865|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338866|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338867|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338868|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338869|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338870|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338871|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
338872|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338953|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338992|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338873|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338874|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338875|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338876|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338877|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338878|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338879|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338880|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338881|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338882|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338883|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338884|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338885|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338886|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338887|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
338888|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
338993|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338889|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
338890|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
338891|NCT00784238|E1|Reported Event|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
338892|NCT00784147|B3|Baseline|Total|Total of all reporting groups
338893|NCT00784147|B2|Baseline|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338894|NCT00784147|B1|Baseline|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338895|NCT00784147|P2|Participant Flow|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338896|NCT00784147|P1|Participant Flow|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338897|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338898|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338899|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338900|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338901|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338902|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338903|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338904|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338905|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338906|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338907|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338908|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338909|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338910|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338911|NCT00784147|E2|Reported Event|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
338912|NCT00784147|E1|Reported Event|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
338913|NCT00784095|B4|Baseline|Total|Total of all reporting groups
338914|NCT00784095|B3|Baseline|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
338915|NCT00784095|B2|Baseline|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338916|NCT00784095|B1|Baseline|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338917|NCT00784095|P3|Participant Flow|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
338918|NCT00784095|P2|Participant Flow|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338919|NCT00784095|P1|Participant Flow|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338920|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
338921|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338954|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338955|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338922|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338923|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
338924|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338925|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338926|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
338927|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338928|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338929|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
338930|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338931|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338932|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
338933|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
338934|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338935|NCT00784095|E3|Reported Event|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
338936|NCT00784095|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects listened to a non-guided relaxation CD."
338937|NCT00784095|E1|Reported Event|Preparation and Completion|"Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
338938|NCT00784030|B3|Baseline|Total|Total of all reporting groups
338939|NCT00784030|B2|Baseline|Healthy Patients|
338940|NCT00784030|B1|Baseline|Polycystic Kidney Disease (PKD) Patients|
338941|NCT00784030|P2|Participant Flow|Healthy Patients|
338942|NCT00784030|P1|Participant Flow|Polycystic Kidney Disease (PKD) Patients|Patients who present with polycystic kidney disease (PKD)
338943|NCT00784030|O2|Outcome|Healthy Controls|Healthy Controls
338944|NCT00784030|O1|Outcome|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
338945|NCT00784030|E2|Reported Event|Healthy Controls|Healthy Controls
338946|NCT00784030|E1|Reported Event|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
338947|NCT00783965|B3|Baseline|Total|Total of all reporting groups
338948|NCT00783965|B2|Baseline|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338949|NCT00783965|B1|Baseline|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338950|NCT00783965|P2|Participant Flow|Arm II|Vehicle (placebo) first, then 0.1% tazarotene cream
338951|NCT00783965|P1|Participant Flow|Arm I|0.1% tazarotene cream first, then placebo
338952|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
340992|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
338956|NCT00783965|E2|Reported Event|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338957|NCT00783965|E1|Reported Event|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
338958|NCT00783835|B1|Baseline|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338959|NCT00783835|P1|Participant Flow|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338960|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338961|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338962|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338963|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338964|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338965|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338966|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338967|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338968|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338969|NCT00783835|E1|Reported Event|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
338970|NCT00783796|B1|Baseline|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338971|NCT00783796|P1|Participant Flow|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
338972|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338973|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338974|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338975|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338976|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338977|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338978|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338979|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338980|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338981|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338982|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338983|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338984|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338985|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338986|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338987|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338988|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338989|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338994|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338995|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338996|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338997|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338998|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
338999|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339000|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339001|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339002|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339003|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339004|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339005|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339006|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339007|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339008|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339009|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339010|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339011|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339012|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339013|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339014|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339015|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339016|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339017|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339018|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339019|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339020|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339021|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339022|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339023|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339024|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339025|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339026|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339027|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339028|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339029|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339030|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339031|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339032|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339033|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339034|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339035|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339036|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339037|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339038|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339039|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339040|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339041|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339042|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339043|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339044|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339045|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339046|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339047|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339048|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339049|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339050|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339051|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339052|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339053|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339054|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339055|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339056|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339057|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339058|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339059|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339060|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339061|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339062|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339063|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339064|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339065|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339066|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339067|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
339068|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
339069|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
339070|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339071|NCT00783796|E1|Reported Event|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
339072|NCT00783718|B4|Baseline|Total|Total of all reporting groups
339073|NCT00783718|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339074|NCT00783718|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339075|NCT00783718|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
339076|NCT00783718|P7|Participant Flow|Maintenance Phase: Non-responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
339077|NCT00783718|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339078|NCT00783718|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
339079|NCT00783718|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339080|NCT00783718|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339081|NCT00783718|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339082|NCT00783718|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
339083|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339084|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339085|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339086|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339087|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339088|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339089|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339090|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339091|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339092|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339093|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339094|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339095|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339096|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339097|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339098|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339099|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339100|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339101|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339102|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339103|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339104|NCT00783718|E3|Reported Event|Vedolizumab|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
339105|NCT00783718|E2|Reported Event|Vedolizumab Then Placebo|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
339106|NCT00783718|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
339107|NCT00783705|B3|Baseline|Total|Total of all reporting groups
339108|NCT00783705|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339109|NCT00783705|B1|Baseline|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339110|NCT00783705|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339111|NCT00783705|P1|Participant Flow|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339112|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339113|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339114|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339115|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339116|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339117|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339118|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339119|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339120|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339121|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339122|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339123|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339124|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339125|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339126|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339127|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339128|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339129|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339130|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339131|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339132|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339133|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339134|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339135|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339136|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339137|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339138|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339139|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339140|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339141|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339142|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339143|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339144|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339145|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339146|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339147|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339148|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339149|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339150|NCT00783705|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339151|NCT00783705|E1|Reported Event|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
339152|NCT00783692|B4|Baseline|Total|Total of all reporting groups
339153|NCT00783692|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339154|NCT00783692|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339155|NCT00783692|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
339156|NCT00783692|P7|Participant Flow|Maintenance Phase: Non-Responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
339157|NCT00783692|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339158|NCT00783692|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
339159|NCT00783692|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339160|NCT00783692|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339161|NCT00783692|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
339162|NCT00783692|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
339163|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339164|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339165|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339166|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339167|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339168|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339169|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339170|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339171|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339172|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339173|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339174|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
339175|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
339176|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
339177|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339178|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339179|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
339180|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
339181|NCT00783692|E3|Reported Event|VDZ/VDZ|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
339182|NCT00783692|E2|Reported Event|VDZ/PBO|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
339183|NCT00783692|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
339184|NCT00783614|B5|Baseline|Total|Total of all reporting groups
339185|NCT00783614|B4|Baseline|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
339186|NCT00783614|B3|Baseline|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
339187|NCT00783614|B2|Baseline|ART and Placebo|Start ART immediately and initiate placebo pill daily
339188|NCT00783614|B1|Baseline|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
339189|NCT00783614|P4|Participant Flow|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
339190|NCT00783614|P3|Participant Flow|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
339191|NCT00783614|P2|Participant Flow|ART and Placebo|Start ART immediately and initiate placebo pill daily
339192|NCT00783614|P1|Participant Flow|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
339193|NCT00783614|O4|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
339194|NCT00783614|O3|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
339195|NCT00783614|O2|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
339196|NCT00783614|O1|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
339197|NCT00783614|E4|Reported Event|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
339198|NCT00783614|E3|Reported Event|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
339199|NCT00783614|E2|Reported Event|ART and Placebo|Start ART immediately and initiate placebo pill daily
339200|NCT00783614|E1|Reported Event|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
339201|NCT00783432|B3|Baseline|Total|Total of all reporting groups
339202|NCT00783432|B2|Baseline|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339203|NCT00783432|B1|Baseline|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339204|NCT00783432|P2|Participant Flow|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339205|NCT00783432|P1|Participant Flow|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339206|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339207|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339208|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339209|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339210|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339211|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339212|NCT00783432|E2|Reported Event|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
339213|NCT00783432|E1|Reported Event|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
339214|NCT00783302|B1|Baseline|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
339215|NCT00783302|P1|Participant Flow|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
339216|NCT00783302|O3|Outcome|Follow-up Period at 12 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.
339217|NCT00783302|O2|Outcome|Follow-up Period at 6 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.
339218|NCT00783302|O1|Outcome|Follow-up Period at 1 Month|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.
339219|NCT00783302|O3|Outcome|Negative Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
339220|NCT00783302|O2|Outcome|Negative Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
339221|NCT00783302|O1|Outcome|Negative Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
339222|NCT00783302|O3|Outcome|Specificity - Subject Follow-up Period 12 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339223|NCT00783302|O2|Outcome|Specificity - Subject Follow-up Period 6 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339224|NCT00783302|O1|Outcome|Specificity - Subject Follow-up Period 1 Month|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339225|NCT00783302|O3|Outcome|Positive Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
339226|NCT00783302|O2|Outcome|Positive Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
339227|NCT00783302|O1|Outcome|Positive Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
339228|NCT00783302|O3|Outcome|Sensitivity - Subject Follow-up Period 12 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339229|NCT00783302|O2|Outcome|Sensitivity - Subject Follow-up Period 6 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339230|NCT00783302|O1|Outcome|Sensitivity - Subject Follow-up Period 1 Month|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
339231|NCT00783302|E1|Reported Event|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
339232|NCT00783263|B5|Baseline|Total|Total of all reporting groups
339233|NCT00783263|B4|Baseline|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339234|NCT00783263|B3|Baseline|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339235|NCT00783263|B2|Baseline|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339236|NCT00783263|B1|Baseline|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339237|NCT00783263|P4|Participant Flow|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339406|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
339238|NCT00783263|P3|Participant Flow|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339239|NCT00783263|P2|Participant Flow|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339240|NCT00783263|P1|Participant Flow|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339241|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
339242|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339243|NCT00783263|O4|Outcome|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339244|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339245|NCT00783263|O2|Outcome|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339246|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339247|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
339248|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339249|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339250|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339251|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339252|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339253|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
339254|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339255|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339256|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339257|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339258|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
339259|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
339260|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
339261|NCT00783263|E4|Reported Event|Rosuva 20 mg|Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
339262|NCT00783263|E3|Reported Event|Rosuva 10 mg + EZ 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
339263|NCT00783263|E2|Reported Event|Rosuva 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
339264|NCT00783263|E1|Reported Event|Rosuva 5 mg + EZ 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
339265|NCT00783224|B5|Baseline|Total|Total of all reporting groups
339266|NCT00783224|B4|Baseline|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
339267|NCT00783224|B3|Baseline|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
339268|NCT00783224|B2|Baseline|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
339407|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
339269|NCT00783224|B1|Baseline|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
339270|NCT00783224|P4|Participant Flow|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
339271|NCT00783224|P3|Participant Flow|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
339272|NCT00783224|P2|Participant Flow|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
339273|NCT00783224|P1|Participant Flow|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
339274|NCT00783224|O4|Outcome|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
339275|NCT00783224|O3|Outcome|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
339276|NCT00783224|O2|Outcome|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
339277|NCT00783224|O1|Outcome|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
339278|NCT00783224|E3|Reported Event|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
339279|NCT00783224|E2|Reported Event|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
339280|NCT00783224|E1|Reported Event|Mometasone Furoate Placebo and Fluticasone Propionate Placebo|Both placebo groups (arms) were combined to report adverse events
339281|NCT00783198|B4|Baseline|Total|Total of all reporting groups
339282|NCT00783198|B3|Baseline|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339283|NCT00783198|B2|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339284|NCT00783198|B1|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339285|NCT00783198|P3|Participant Flow|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339286|NCT00783198|P2|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339287|NCT00783198|P1|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339288|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339289|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339290|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339291|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339292|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339293|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339294|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339295|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339296|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339297|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339298|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339299|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339300|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339301|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339302|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339303|NCT00783198|E3|Reported Event|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339405|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
339304|NCT00783198|E2|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339305|NCT00783198|E1|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
339306|NCT00783094|B4|Baseline|Total|Total of all reporting groups
339307|NCT00783094|B3|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339308|NCT00783094|B2|Baseline|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339309|NCT00783094|B1|Baseline|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339310|NCT00783094|P3|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339311|NCT00783094|P2|Participant Flow|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339312|NCT00783094|P1|Participant Flow|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339313|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339314|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339315|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339316|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339317|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339318|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339319|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339320|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339321|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339322|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339323|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339324|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339325|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339326|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339327|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339328|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339329|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339330|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339331|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339332|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339333|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339334|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339335|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339336|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339337|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339338|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339339|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339340|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339341|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339342|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339343|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339344|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339345|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339346|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339347|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339348|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339349|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339350|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339351|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339352|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339353|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339354|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339355|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339356|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339357|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339358|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339359|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339360|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339361|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339362|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339363|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339364|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339365|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339366|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339367|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339368|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339369|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339370|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339371|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339372|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339373|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339374|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339375|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339376|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339377|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339378|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
339379|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339380|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
339381|NCT00783094|E6|Reported Event|Placebo: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
339382|NCT00783094|E5|Reported Event|Tadalafil 5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
339383|NCT00783094|E4|Reported Event|Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
339384|NCT00783094|E3|Reported Event|Placebo - Double-Blind Phase|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase."
339385|NCT00783094|E2|Reported Event|Tadalafil 5 mg - Double-Blind Phase|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
339386|NCT00783094|E1|Reported Event|Tadalafil 2.5 mg - Double-Blind Phase|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
339387|NCT00782834|B1|Baseline|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
339388|NCT00782834|P1|Participant Flow|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
339389|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
339390|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
339391|NCT00782834|E1|Reported Event|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
339392|NCT00782821|B5|Baseline|Total|Total of all reporting groups
339393|NCT00782821|B4|Baseline|RATG/Rituxan/Velcade|"Thymoglobulin x 4 doses (1.5mg/kg IV)+ Rituximab 200mg/m2 IV + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
339394|NCT00782821|B3|Baseline|RATG/Velcade|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
339395|NCT00782821|B2|Baseline|RATG/Rituxan|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV)+ Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
339396|NCT00782821|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV) Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily).
339397|NCT00782821|P4|Participant Flow|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses (1.5mg/kg IV). + Rituximab 200mg/m2 IV + Bortezomib 1.3 mg/m2 IVP Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone.
339398|NCT00782821|P3|Participant Flow|RATG/Velcade|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone."
339399|NCT00782821|P2|Participant Flow|RATG/Rituxan|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
339400|NCT00782821|P1|Participant Flow|Rabbit Antithymocyte Globulin (rATG)|"Thymoglobulin x 6 doses (1.5mg/kg IV).~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
339401|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
339402|NCT00782821|O3|Outcome|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
339403|NCT00782821|O2|Outcome|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
339404|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
339408|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV)
339409|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
339410|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Bortezomib
339411|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
339412|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
339413|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
339414|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
339415|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
339416|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
339417|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
339418|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
339419|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
339420|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
339421|NCT00782821|E4|Reported Event|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
339422|NCT00782821|E3|Reported Event|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
339423|NCT00782821|E2|Reported Event|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
339424|NCT00782821|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
339425|NCT00782717|B3|Baseline|Total|Total of all reporting groups
339426|NCT00782717|B2|Baseline|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339427|NCT00782717|B1|Baseline|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339428|NCT00782717|P2|Participant Flow|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339429|NCT00782717|P1|Participant Flow|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339430|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339431|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339432|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339433|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339434|NCT00782717|E2|Reported Event|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339435|NCT00782717|E1|Reported Event|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
339436|NCT00782639|B3|Baseline|Total|Total of all reporting groups
339437|NCT00782639|B2|Baseline|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339438|NCT00782639|B1|Baseline|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339439|NCT00782639|P2|Participant Flow|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339440|NCT00782639|P1|Participant Flow|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339441|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 milligrams of iodine per milliliter [mgI/mL] concentration)
339442|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 milligrams of iodine per milliliter [mgI/mL] concentration)
339443|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339444|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339445|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339446|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339447|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339448|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339449|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339450|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339451|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339452|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339453|NCT00782639|E2|Reported Event|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
339454|NCT00782639|E1|Reported Event|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
339455|NCT00782626|B1|Baseline|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
339456|NCT00782626|P1|Participant Flow|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
339510|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339511|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339457|NCT00782626|O1|Outcome|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
339458|NCT00782626|E1|Reported Event|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
339459|NCT00782509|B4|Baseline|Total|Total of all reporting groups
339460|NCT00782509|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339461|NCT00782509|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339462|NCT00782509|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339463|NCT00782509|P3|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339464|NCT00782509|P2|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339465|NCT00782509|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339466|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339467|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339468|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339469|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339470|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339471|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339472|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339473|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339474|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339475|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339476|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339477|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339478|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339479|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339480|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339481|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339482|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339483|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339484|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339485|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339486|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339487|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339488|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339489|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339490|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339491|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339492|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339493|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339494|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339495|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339496|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339497|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339498|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339499|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339500|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339501|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339502|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339503|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339504|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339505|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339506|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339507|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339508|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339509|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339512|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339513|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339514|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339515|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339516|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339517|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339518|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339519|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339520|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339521|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339522|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339523|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339524|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339525|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339526|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339527|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339528|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339529|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339530|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339531|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339532|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339533|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339534|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339535|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339536|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339537|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339538|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339539|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339540|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339541|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339542|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339543|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339544|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339545|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339546|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339547|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339548|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339549|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339550|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339551|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339552|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339553|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339554|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339555|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339556|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339557|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339558|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339559|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339560|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339561|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339562|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339563|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339564|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339565|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339566|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339567|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339568|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339569|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339570|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339571|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339572|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
340993|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
339573|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339574|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339575|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339576|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339577|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339578|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339579|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339580|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339581|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339582|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339583|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339584|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339585|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339586|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339587|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339588|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339589|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339590|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339591|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339592|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339593|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339594|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339595|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339596|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339597|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339598|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339599|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339600|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339601|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339602|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339603|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339604|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339605|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339606|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339607|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339608|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339609|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339610|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339611|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339612|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339613|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339614|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339615|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339616|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339617|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339618|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339619|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339620|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339621|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339622|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339623|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339624|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339625|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339626|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339627|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339628|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339629|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339630|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339631|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339632|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339633|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339841|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339634|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339635|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339636|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339637|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339638|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339639|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339640|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339641|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339642|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339643|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339644|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339645|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339646|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339647|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339648|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339649|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339650|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339651|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339652|NCT00782509|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339653|NCT00782509|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339654|NCT00782509|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339655|NCT00782496|B3|Baseline|Total|Total of all reporting groups
339656|NCT00782496|B2|Baseline|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
339657|NCT00782496|B1|Baseline|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
339658|NCT00782496|P2|Participant Flow|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
339659|NCT00782496|P1|Participant Flow|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
339660|NCT00782496|O1|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
339661|NCT00782496|O2|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
339662|NCT00782496|O1|Outcome|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
339663|NCT00782496|E2|Reported Event|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
339664|NCT00782496|E1|Reported Event|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
339665|NCT00782483|B1|Baseline|Overall|Overall Study Group
339666|NCT00782483|P1|Participant Flow|Laser Therapy|Total number of participants
339667|NCT00782483|O1|Outcome|Laser Therapy|Total number of participants
339668|NCT00782483|E1|Reported Event|Overall|Overall Study Group
339669|NCT00782418|B1|Baseline|All Patients|All patients from all arms
339670|NCT00782418|P7|Participant Flow|Placebo (HGC or GGI)|Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo
339671|NCT00782418|P6|Participant Flow|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
339672|NCT00782418|P5|Participant Flow|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
339673|NCT00782418|P4|Participant Flow|Exenatide 5 ug Down Dosed to Placebo (HGC)|Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
339674|NCT00782418|P3|Participant Flow|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
339675|NCT00782418|P2|Participant Flow|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
339676|NCT00782418|P1|Participant Flow|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
339677|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
339678|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
339679|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
339680|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
339681|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
339682|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
339683|NCT00782418|O6|Outcome|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
339684|NCT00782418|O5|Outcome|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
339685|NCT00782418|O4|Outcome|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
339686|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
339687|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
339688|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
339689|NCT00782418|E6|Reported Event|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
339690|NCT00782418|E5|Reported Event|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
339691|NCT00782418|E4|Reported Event|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
339692|NCT00782418|E3|Reported Event|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
339964|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339693|NCT00782418|E2|Reported Event|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
339694|NCT00782418|E1|Reported Event|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
339695|NCT00782379|B1|Baseline|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339696|NCT00782379|P1|Participant Flow|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339697|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339698|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339699|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339700|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339701|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339702|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339703|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339704|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339705|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339706|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339707|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339708|NCT00782379|E1|Reported Event|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
339709|NCT00782340|B4|Baseline|Total|Total of all reporting groups
339710|NCT00782340|B3|Baseline|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339711|NCT00782340|B2|Baseline|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339712|NCT00782340|B1|Baseline|Not Randomized|Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
339713|NCT00782340|P3|Participant Flow|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339714|NCT00782340|P2|Participant Flow|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339715|NCT00782340|P1|Participant Flow|Open-Label Titration|All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
339716|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339717|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339718|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339719|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339738|NCT00782288|B3|Baseline|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
340994|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
339720|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339721|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339722|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339723|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339724|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339725|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339726|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339727|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339728|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339729|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339730|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339731|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339732|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339733|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339734|NCT00782340|E3|Reported Event|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339735|NCT00782340|E2|Reported Event|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
339736|NCT00782340|E1|Reported Event|Open-Label Titration|All patients treated with study drug during dose titration (7-14 days)
339737|NCT00782288|B4|Baseline|Total|Total of all reporting groups
339739|NCT00782288|B2|Baseline|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339740|NCT00782288|B1|Baseline|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339741|NCT00782288|P3|Participant Flow|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339742|NCT00782288|P2|Participant Flow|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339743|NCT00782288|P1|Participant Flow|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339744|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339745|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339746|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339747|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339748|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339749|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339750|NCT00782288|O1|Outcome|All Participants|All study participants had nasal cells collected pre and post treatment during the study. Because the data set is extremely large, the full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) this information can be obtained under the accession number.
339751|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339752|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339753|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339754|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339755|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339756|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339757|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339758|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339759|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339760|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339761|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339762|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339763|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339764|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339765|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339766|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339767|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339768|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339769|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339770|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339771|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339772|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339773|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339774|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339775|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339776|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339777|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339778|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339779|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339780|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339781|NCT00782288|E3|Reported Event|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
339782|NCT00782288|E2|Reported Event|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
339783|NCT00782288|E1|Reported Event|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
339784|NCT00782210|B4|Baseline|Total|Total of all reporting groups
339785|NCT00782210|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339786|NCT00782210|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339787|NCT00782210|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339788|NCT00782210|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339789|NCT00782210|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339790|NCT00782210|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339791|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339792|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339793|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339794|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339795|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339796|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339797|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339798|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339799|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339800|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339801|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339802|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339803|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339804|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339805|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339806|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339807|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339808|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339809|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339810|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339811|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339812|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339813|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339814|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339815|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339816|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339817|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339818|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339819|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339820|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
339821|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
339822|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
339823|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
339824|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339825|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339826|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339827|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339828|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339829|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339830|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339831|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339832|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339833|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339834|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339835|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339836|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339837|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339838|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339839|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339840|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
340995|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
339842|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339843|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339844|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339845|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339846|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339847|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339848|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339849|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339850|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339851|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339852|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339853|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339854|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339855|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339856|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339857|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339858|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339859|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339860|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339861|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339862|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339863|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339864|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339865|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339866|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339867|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339868|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339869|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339870|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339871|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339872|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339873|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339874|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339875|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339876|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339877|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339878|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339879|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339880|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339881|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339882|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339883|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339884|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339885|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339886|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339887|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339888|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339889|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339890|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339891|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339892|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339893|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339894|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339895|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339896|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339897|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339898|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339899|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339900|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339901|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339902|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339903|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339904|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339905|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339906|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339907|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339908|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339909|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339910|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339911|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339912|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339913|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339914|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339915|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339916|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339917|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339918|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339919|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339920|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339921|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339922|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339923|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339924|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339925|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339926|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339927|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339928|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339929|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339930|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339931|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339932|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339933|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339934|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339935|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339936|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339937|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339938|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339939|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339940|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339941|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339942|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339943|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339944|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339945|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339946|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339947|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339948|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339949|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339950|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339951|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339952|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339953|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339954|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339955|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339956|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339957|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339958|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339959|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339960|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339961|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339962|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339963|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
340996|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
339965|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
339966|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339967|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339968|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339969|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339970|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339971|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339972|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339973|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339974|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339975|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339976|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339977|NCT00782210|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
339978|NCT00782210|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
339979|NCT00782210|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
339980|NCT00782184|B3|Baseline|Total|Total of all reporting groups
339981|NCT00782184|B2|Baseline|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339982|NCT00782184|B1|Baseline|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339983|NCT00782184|P2|Participant Flow|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339984|NCT00782184|P1|Participant Flow|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339985|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339986|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339987|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339988|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339989|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339990|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339991|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339992|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339993|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339994|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339995|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339996|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339997|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
339998|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
339999|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340000|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340001|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340002|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340003|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340004|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340005|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340006|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340007|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340008|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340009|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340010|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340011|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340012|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340013|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340014|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340015|NCT00782184|E3|Reported Event|Placebo|One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period.
340016|NCT00782184|E2|Reported Event|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
340017|NCT00782184|E1|Reported Event|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
340018|NCT00781963|B4|Baseline|Total|Total of all reporting groups
340019|NCT00781963|B3|Baseline|Control|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340020|NCT00781963|B2|Baseline|Group CBTI|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340021|NCT00781963|B1|Baseline|Individual CBTI|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
340022|NCT00781963|P3|Participant Flow|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340023|NCT00781963|P2|Participant Flow|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340024|NCT00781963|P1|Participant Flow|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
340025|NCT00781963|O3|Outcome|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340026|NCT00781963|O2|Outcome|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340997|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340027|NCT00781963|O1|Outcome|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
340028|NCT00781963|E3|Reported Event|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340029|NCT00781963|E2|Reported Event|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
340030|NCT00781963|E1|Reported Event|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
340031|NCT00781950|B3|Baseline|Total|Total of all reporting groups
340032|NCT00781950|B2|Baseline|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
340033|NCT00781950|B1|Baseline|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
340034|NCT00781950|P2|Participant Flow|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
340035|NCT00781950|P1|Participant Flow|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
340036|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
340037|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
340038|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
340039|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
340040|NCT00781950|E2|Reported Event|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
340041|NCT00781950|E1|Reported Event|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
340042|NCT00781937|B3|Baseline|Total|Total of all reporting groups
340043|NCT00781937|B2|Baseline|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340044|NCT00781937|B1|Baseline|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340045|NCT00781937|P2|Participant Flow|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340046|NCT00781937|P1|Participant Flow|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340047|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340048|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340116|NCT00781599|P1|Participant Flow|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340049|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340050|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340051|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340052|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340053|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340054|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340055|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340056|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340057|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340058|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340059|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340060|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340061|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340062|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340147|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340597|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
340063|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340064|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340065|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340066|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340067|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340068|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340069|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340070|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340071|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340072|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340073|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340074|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340075|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340076|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340148|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340998|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340077|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340078|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340079|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340080|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340081|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340082|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340083|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340084|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340085|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340086|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340087|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340088|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340089|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340090|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340149|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340598|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
340091|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340092|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340093|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340094|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340095|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340096|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340097|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340098|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340099|NCT00781937|E2|Reported Event|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
340100|NCT00781937|E1|Reported Event|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
340101|NCT00781859|B3|Baseline|Total|Total of all reporting groups
340102|NCT00781859|B2|Baseline|Placebo|Intravitreal injection of placebo
340103|NCT00781859|B1|Baseline|Ocriplasmin 125µg|125µg microplasmin intravitreal injection
340104|NCT00781859|P2|Participant Flow|Placebo|Intravitreal injection of placebo
340105|NCT00781859|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
340106|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
340107|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
340108|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
340109|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
340110|NCT00781859|E2|Reported Event|Placebo|Intravitreal injection of placebo
340111|NCT00781859|E1|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
340112|NCT00781599|B3|Baseline|Total|Total of all reporting groups
340113|NCT00781599|B2|Baseline|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340114|NCT00781599|B1|Baseline|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340115|NCT00781599|P2|Participant Flow|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340117|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340118|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340119|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340120|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340121|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340122|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340123|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340124|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340125|NCT00781599|E2|Reported Event|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
340126|NCT00781599|E1|Reported Event|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
340127|NCT00781508|B3|Baseline|Total|Total of all reporting groups
340128|NCT00781508|B2|Baseline|Placebo First Sildenafil Second|Effect of placebo on left ventricular filling pressures in patients with heart failure
340129|NCT00781508|B1|Baseline|Sildenafil First Placebo Second|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
340130|NCT00781508|P2|Participant Flow|Placebo Then Sildenafil|Effect of Sildenafil on left ventricular function
340131|NCT00781508|P1|Participant Flow|Sildenafil Then Placebo|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
340132|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo orally, then sildenafil 50 mg orally 2 days later.
340133|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|Sildenafil 50 mg orally, placebo orally 2 days later.
340134|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo administered orally, then sildenafil orally 48 hrs later
340135|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|sildenafil 50 mg administered orally, placebo administered orally 48 hrs later
340136|NCT00781508|E2|Reported Event|Placebo First Then Sildenafil|Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
340137|NCT00781508|E1|Reported Event|Sildenafil First Then Placebo|Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure
340138|NCT00781456|B3|Baseline|Total|Total of all reporting groups
340139|NCT00781456|B2|Baseline|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340140|NCT00781456|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340141|NCT00781456|P2|Participant Flow|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340142|NCT00781456|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340143|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340144|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340145|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340146|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340999|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340150|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340151|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340152|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340153|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340154|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340155|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340156|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340157|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340158|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340159|NCT00781456|E2|Reported Event|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
340160|NCT00781456|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
340161|NCT00781391|B4|Baseline|Total|Total of all reporting groups
340162|NCT00781391|B3|Baseline|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340163|NCT00781391|B2|Baseline|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340164|NCT00781391|B1|Baseline|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340165|NCT00781391|P3|Participant Flow|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340166|NCT00781391|P2|Participant Flow|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340167|NCT00781391|P1|Participant Flow|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340168|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340169|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340170|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340171|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340172|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340173|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340174|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340175|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340176|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340177|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340605|NCT00778999|P2|Participant Flow|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
340178|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340179|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340180|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340181|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340182|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340183|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340184|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340185|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340186|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340187|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340188|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340189|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340190|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340191|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340192|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340193|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340194|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340195|NCT00781391|E3|Reported Event|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340196|NCT00781391|E2|Reported Event|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
340197|NCT00781391|E1|Reported Event|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
340198|NCT00781365|B3|Baseline|Total|Total of all reporting groups
340199|NCT00781365|B2|Baseline|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340200|NCT00781365|B1|Baseline|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340201|NCT00781365|P2|Participant Flow|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340202|NCT00781365|P1|Participant Flow|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340231|NCT00780910|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340203|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340204|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340205|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340206|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340207|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340208|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340209|NCT00781365|E2|Reported Event|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
340210|NCT00781365|E1|Reported Event|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
340211|NCT00781326|B1|Baseline|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
340212|NCT00781326|P1|Participant Flow|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
340213|NCT00781326|O1|Outcome|Open Label Antidepressant|"In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.~Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.~Placebo: Placebo will be given in doses matching those of nimodipine."
340214|NCT00781326|E1|Reported Event|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
340215|NCT00781274|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340216|NCT00781274|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340217|NCT00781274|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340218|NCT00781274|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340219|NCT00781079|B3|Baseline|Total|Total of all reporting groups
340220|NCT00781079|B2|Baseline|Arm 2|Care as usual
340221|NCT00781079|B1|Baseline|Arm 1|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
340222|NCT00781079|P2|Participant Flow|Arm 2|Care as usual
340223|NCT00781079|P1|Participant Flow|Arm 1|"Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)~Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA): Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)"
340224|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
340225|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
340226|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
340227|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
340228|NCT00781079|E2|Reported Event|Case as Usual|Care as usual on case management teams
340229|NCT00781079|E1|Reported Event|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
340230|NCT00780910|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340232|NCT00780910|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340233|NCT00780910|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340234|NCT00780741|B3|Baseline|Total|Total of all reporting groups
340235|NCT00780741|B2|Baseline|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340236|NCT00780741|B1|Baseline|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340237|NCT00780741|P2|Participant Flow|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340238|NCT00780741|P1|Participant Flow|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340239|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340240|NCT00780741|O1|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
340241|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340242|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340243|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340244|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340245|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340246|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340247|NCT00780741|E2|Reported Event|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340248|NCT00780741|E1|Reported Event|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
340249|NCT00780676|B6|Baseline|Total|Total of all reporting groups
340250|NCT00780676|B5|Baseline|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
340251|NCT00780676|B4|Baseline|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
340252|NCT00780676|B3|Baseline|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340253|NCT00780676|B2|Baseline|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340254|NCT00780676|B1|Baseline|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340255|NCT00780676|P5|Participant Flow|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
340256|NCT00780676|P4|Participant Flow|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway activity predictor positive) receive selumetinib 75 mg by mouth twice daily (BID).
340257|NCT00780676|P3|Participant Flow|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340258|NCT00780676|P2|Participant Flow|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340259|NCT00780676|P1|Participant Flow|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340260|NCT00780676|O3|Outcome|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340599|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
340261|NCT00780676|O2|Outcome|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340262|NCT00780676|O1|Outcome|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
340263|NCT00780676|E1|Reported Event|Dasatinib 100 mg|Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
340264|NCT00780572|B3|Baseline|Total|Total of all reporting groups
340265|NCT00780572|B2|Baseline|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
340266|NCT00780572|B1|Baseline|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
340267|NCT00780572|P2|Participant Flow|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
340268|NCT00780572|P1|Participant Flow|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
340269|NCT00780572|O2|Outcome|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
340270|NCT00780572|O1|Outcome|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
340271|NCT00780572|E2|Reported Event|Arm 2: Control/No Alert|The second arm is the control. Alerts will not be displayed for these patients.
340272|NCT00780572|E1|Reported Event|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
340273|NCT00780455|B3|Baseline|Total|Total of all reporting groups
340274|NCT00780455|B2|Baseline|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340275|NCT00780455|B1|Baseline|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340276|NCT00780455|P2|Participant Flow|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340277|NCT00780455|P1|Participant Flow|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340278|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340279|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340280|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340281|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340282|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340283|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340600|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
340284|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340285|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340286|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340287|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340288|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340289|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340290|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340291|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340292|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340293|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340294|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340295|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340296|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340297|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340298|NCT00780455|E2|Reported Event|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340299|NCT00780455|E1|Reported Event|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
340300|NCT00780416|B3|Baseline|Total|Total of all reporting groups
340301|NCT00780416|B2|Baseline|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
340302|NCT00780416|B1|Baseline|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340303|NCT00780416|P2|Participant Flow|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
340601|NCT00779025|E1|Reported Event|Overall Study|
340304|NCT00780416|P1|Participant Flow|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340305|NCT00780416|O2|Outcome|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
340306|NCT00780416|O1|Outcome|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340307|NCT00780416|E2|Reported Event|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
340308|NCT00780416|E1|Reported Event|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
340309|NCT00780403|B1|Baseline|Total Population|All randomized subjects.
340310|NCT00780403|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
340311|NCT00780403|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
340312|NCT00780403|O3|Outcome|No Preference|All randomized subjects.
340313|NCT00780403|O2|Outcome|Zyrtec|All randomized subjects.
340314|NCT00780403|O1|Outcome|RediTab|All randomized subjects.
340315|NCT00780403|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
340316|NCT00780403|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
340317|NCT00780338|B3|Baseline|Total|Total of all reporting groups
340318|NCT00780338|B2|Baseline|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340319|NCT00780338|B1|Baseline|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340320|NCT00780338|P2|Participant Flow|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340321|NCT00780338|P1|Participant Flow|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340322|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340323|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340324|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
340325|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
340326|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340363|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
340364|NCT00779246|E2|Reported Event|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
340327|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340328|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
340329|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
340330|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340331|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340332|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340333|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340334|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
340335|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
340336|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
340337|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
340338|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
340339|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
340340|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340341|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340342|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340343|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340344|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340345|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340346|NCT00780338|E2|Reported Event|Control|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340347|NCT00780338|E1|Reported Event|AGTO|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
340348|NCT00780273|B1|Baseline|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
340349|NCT00780273|P1|Participant Flow|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
340350|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
340351|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
340352|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
340353|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
340354|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
340355|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
340356|NCT00780273|E1|Reported Event|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study."
340357|NCT00779246|B3|Baseline|Total|Total of all reporting groups
340358|NCT00779246|B2|Baseline|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
340359|NCT00779246|B1|Baseline|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
340360|NCT00779246|P2|Participant Flow|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
340361|NCT00779246|P1|Participant Flow|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
340362|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
340602|NCT00778999|B3|Baseline|Total|Total of all reporting groups
340365|NCT00779246|E1|Reported Event|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
340366|NCT00779857|B1|Baseline|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
340367|NCT00779857|P1|Participant Flow|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
340368|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
340369|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
340370|NCT00779857|E1|Reported Event|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
340371|NCT00779779|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340372|NCT00779779|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340373|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340374|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340375|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340376|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340377|NCT00779779|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
340378|NCT00779766|B3|Baseline|Total|Total of all reporting groups
340379|NCT00779766|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340380|NCT00779766|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340381|NCT00779766|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340382|NCT00779766|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340383|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340384|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340385|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
340386|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340387|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340388|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340389|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340390|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340391|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
340392|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
340393|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340394|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340395|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
341000|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340396|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340397|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340398|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340399|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340400|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340401|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340402|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340403|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340404|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340405|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340406|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340407|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340408|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340409|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340410|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340411|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340412|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340413|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340414|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340415|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340416|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340417|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340418|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340419|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340420|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340421|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340422|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340423|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340424|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340425|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340426|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340603|NCT00778999|B2|Baseline|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
340427|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340428|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340429|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340430|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340431|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340432|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340433|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340434|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340435|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340436|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340437|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340438|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340439|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340440|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340441|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340442|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340443|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340444|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340445|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340446|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340447|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340448|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340449|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340450|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340451|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340452|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340453|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340454|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340455|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340456|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340457|NCT00779766|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340604|NCT00778999|B1|Baseline|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
340458|NCT00779766|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
340459|NCT00779701|B1|Baseline|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
340460|NCT00779701|P1|Participant Flow|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
340461|NCT00779701|O1|Outcome|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
340462|NCT00779701|E1|Reported Event|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
340463|NCT00779675|B1|Baseline|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340464|NCT00779675|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340465|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340466|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340467|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340468|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340469|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340470|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
340471|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
340472|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
340473|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
340474|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Week 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characterisitics (SPC; European Union), or local labelling (for all other countries).
340475|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2,6, and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries)
340476|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries).
340508|NCT00779506|E1|Reported Event|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340509|NCT00779311|B6|Baseline|Total|Total of all reporting groups
340477|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340478|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340479|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340480|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340481|NCT00779675|E1|Reported Event|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
340482|NCT00779558|B3|Baseline|Total|Total of all reporting groups
340483|NCT00779558|B2|Baseline|Placebo|Placebo - normal saline infusion
340484|NCT00779558|B1|Baseline|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340485|NCT00779558|P2|Participant Flow|Placebo|Placebo - normal saline infusion
340486|NCT00779558|P1|Participant Flow|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340487|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
340488|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340489|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
340490|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340491|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
340492|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340493|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
340494|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340495|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
340496|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340497|NCT00779558|E2|Reported Event|Placebo|Placebo - normal saline infusion
340498|NCT00779558|E1|Reported Event|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
340499|NCT00779506|B1|Baseline|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340500|NCT00779506|P1|Participant Flow|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340501|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340502|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340503|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340504|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340505|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340506|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340507|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
340571|NCT00779155|E1|Reported Event|Inactive Resonator Device|inactive magnetic fields with placebo fields
340510|NCT00779311|B5|Baseline|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340511|NCT00779311|B4|Baseline|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340512|NCT00779311|B3|Baseline|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340513|NCT00779311|B2|Baseline|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340514|NCT00779311|B1|Baseline|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340515|NCT00779311|P5|Participant Flow|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340516|NCT00779311|P4|Participant Flow|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340517|NCT00779311|P3|Participant Flow|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340518|NCT00779311|P2|Participant Flow|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340519|NCT00779311|P1|Participant Flow|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340520|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340521|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340522|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340523|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340524|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340525|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340526|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340527|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340528|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340529|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340530|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340531|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340532|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340533|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340534|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340535|NCT00779311|E5|Reported Event|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
340536|NCT00779311|E4|Reported Event|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
340537|NCT00779311|E3|Reported Event|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
340596|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
341001|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340538|NCT00779311|E2|Reported Event|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
340539|NCT00779311|E1|Reported Event|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
340540|NCT00779285|B1|Baseline|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
340541|NCT00779285|P1|Participant Flow|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
340542|NCT00779285|O1|Outcome|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
340543|NCT00779285|E1|Reported Event|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
340544|NCT00779259|B1|Baseline|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
340545|NCT00779259|P1|Participant Flow|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
340546|NCT00779259|O2|Outcome|4 Hours After Co-Administered Dose of Theophylline/Quinine|measured 4 hours after the 7 am co-administered dose of theophylline and quinine
340547|NCT00779259|O1|Outcome|1 Hour Before Co-Administered Dose of Theophylline/Quinine|measured 1 hour prior to the 7 am co-administered dose of theophylline and quinine
340548|NCT00779259|O2|Outcome|4 Hours After Morning Dose of Quinine on Study Day 11|measured 4 hours after the morning dose of quinine
340549|NCT00779259|O1|Outcome|1 Hour Before Morning Dose of Quinine on Study Day 11|measured 1 hour prior to the morning dose of Quinine on study Day 11
340550|NCT00779259|O2|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
340551|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
340552|NCT00779259|O4|Outcome|Quinine in Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
340553|NCT00779259|O3|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
340554|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
340555|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
340556|NCT00779259|O4|Outcome|Quinine in the Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
340557|NCT00779259|O3|Outcome|Theophylline in the Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
340558|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11.
340559|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration)followed by a 4-day washout period.
340560|NCT00779259|E3|Reported Event|Theophylline Co-administered With Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules).
340561|NCT00779259|E2|Reported Event|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
340562|NCT00779259|E1|Reported Event|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
340563|NCT00779155|B3|Baseline|Total|Total of all reporting groups
340564|NCT00779155|B2|Baseline|Active Resonator Device|Active pico-tesla magnetic fields
340565|NCT00779155|B1|Baseline|Inactive Resonator Device|inactive magnetic fields with placebo fields
340566|NCT00779155|P2|Participant Flow|Active Resonator Device|Active pico-tesla magnetic fields
340567|NCT00779155|P1|Participant Flow|Inactive Resonator Device|inactive magnetic fields with placebo fields
340568|NCT00779155|O2|Outcome|Active Resonator Device|Active pico-tesla magnetic fields
340569|NCT00779155|O1|Outcome|Inactive Resonator Device|inactive magnetic fields with placebo fields
340570|NCT00779155|E2|Reported Event|Active Resonator Device|Active pico-tesla magnetic fields
340572|NCT00779142|B1|Baseline|Methotrexate 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
340573|NCT00779142|P1|Participant Flow|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
340574|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
340575|NCT00779142|E1|Reported Event|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
340576|NCT00779116|B1|Baseline|Total Population|All randomized subjects
340577|NCT00779116|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
340578|NCT00779116|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.
340579|NCT00779116|O3|Outcome|No Preference|All randomized subjects.
340580|NCT00779116|O2|Outcome|Zyrtec|All randomized subjects.
340581|NCT00779116|O1|Outcome|RediTab|All randomized subjects.
340582|NCT00779116|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab (first and second intervention period).
340583|NCT00779116|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
340584|NCT00779038|B1|Baseline|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340585|NCT00779038|P1|Participant Flow|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340586|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340587|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340588|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340589|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340590|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340591|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340592|NCT00779038|E1|Reported Event|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
340593|NCT00779025|B1|Baseline|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
340594|NCT00779025|P1|Participant Flow|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
340595|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
340606|NCT00778999|P1|Participant Flow|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
340607|NCT00778999|O2|Outcome|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
340608|NCT00778999|O1|Outcome|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
340609|NCT00778999|E2|Reported Event|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
340610|NCT00778999|E1|Reported Event|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
340611|NCT00778921|B4|Baseline|Total|Total of all reporting groups
340612|NCT00778921|B3|Baseline|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
340613|NCT00778921|B2|Baseline|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
340614|NCT00778921|B1|Baseline|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
340615|NCT00778921|P3|Participant Flow|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
340616|NCT00778921|P2|Participant Flow|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
340617|NCT00778921|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
340618|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
340619|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
340620|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
340621|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
340622|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
340623|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
340624|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
340625|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
340626|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
340627|NCT00778921|E3|Reported Event|Amlodipine 10mg|Amlodipine 10mg
340628|NCT00778921|E2|Reported Event|Aliskiren 150mg/ Amlodipine 10mg|Aliskiren 150mg/ Amlodipine 10mg
340629|NCT00778921|E1|Reported Event|Aliskiren 300mg/ Amlodipine 10mg|Aliskiren 300mg/ Amlodipine 10mg
340630|NCT00778895|B4|Baseline|Total|Total of all reporting groups
340631|NCT00778895|B3|Baseline|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340632|NCT00778895|B2|Baseline|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340633|NCT00778895|B1|Baseline|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340634|NCT00778895|P3|Participant Flow|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340635|NCT00778895|P2|Participant Flow|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340636|NCT00778895|P1|Participant Flow|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340637|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340638|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340639|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340757|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340640|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340641|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340642|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340643|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340644|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340645|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340646|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340647|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340648|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340649|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340650|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340651|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340652|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340653|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340654|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340655|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340656|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340657|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340758|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340759|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340658|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340659|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340660|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340661|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340662|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340663|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340664|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340665|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340666|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340667|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340668|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340669|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340670|NCT00778895|E3|Reported Event|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340671|NCT00778895|E2|Reported Event|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340672|NCT00778895|E1|Reported Event|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
340673|NCT00778869|B1|Baseline|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
340674|NCT00778869|P1|Participant Flow|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
340675|NCT00778869|O1|Outcome|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
340676|NCT00778869|E1|Reported Event|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
340677|NCT00778830|B3|Baseline|Total|Total of all reporting groups
340760|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340761|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340762|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340678|NCT00778830|B2|Baseline|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340679|NCT00778830|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340680|NCT00778830|P2|Participant Flow|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340681|NCT00778830|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340682|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340683|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340684|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340685|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340686|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340687|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340688|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340689|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
340763|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340764|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340765|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340690|NCT00778830|E2|Reported Event|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
340691|NCT00778830|E1|Reported Event|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
340692|NCT00778817|B1|Baseline|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340693|NCT00778817|P1|Participant Flow|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340694|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340695|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340696|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340697|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340698|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340699|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340700|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340701|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340702|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340703|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340704|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340705|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340706|NCT00778817|E1|Reported Event|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
340707|NCT00778648|B3|Baseline|Total|Total of all reporting groups
340708|NCT00778648|B2|Baseline|Placebo|
340709|NCT00778648|B1|Baseline|Juice Plus|
340710|NCT00778648|P2|Participant Flow|Placebo|
340711|NCT00778648|P1|Participant Flow|Juice Plus|
340712|NCT00778648|O2|Outcome|Placebo|
340713|NCT00778648|O1|Outcome|Juice Plus|
340714|NCT00778648|E2|Reported Event|Placebo|
340715|NCT00778648|E1|Reported Event|Juice Plus|
340716|NCT00778622|B4|Baseline|Total|Total of all reporting groups
340717|NCT00778622|B3|Baseline|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340718|NCT00778622|B2|Baseline|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340719|NCT00778622|B1|Baseline|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340766|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340767|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340768|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340769|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340720|NCT00778622|P3|Participant Flow|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
340721|NCT00778622|P2|Participant Flow|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
340722|NCT00778622|P1|Participant Flow|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
340723|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340724|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340725|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
340726|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340727|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340728|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340729|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340730|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340731|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340732|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340733|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340734|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340735|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340736|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340737|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340738|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340739|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340740|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340741|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340742|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340743|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340744|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340745|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340746|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340747|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340748|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340749|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340750|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340751|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340752|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340753|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340754|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340755|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340756|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
341002|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340770|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
340771|NCT00778622|E3|Reported Event|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
340772|NCT00778622|E2|Reported Event|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
340773|NCT00778622|E1|Reported Event|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
340774|NCT00778375|B1|Baseline|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340775|NCT00778375|P1|Participant Flow|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340776|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340777|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340778|NCT00778375|O2|Outcome|Re-Induction|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340779|NCT00778375|O1|Outcome|Induction Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340780|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340781|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340782|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340783|NCT00778375|E1|Reported Event|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
340784|NCT00778336|B5|Baseline|Total|Total of all reporting groups
340785|NCT00778336|B4|Baseline|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340786|NCT00778336|B3|Baseline|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340787|NCT00778336|B2|Baseline|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
340788|NCT00778336|B1|Baseline|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
340789|NCT00778336|P4|Participant Flow|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340790|NCT00778336|P3|Participant Flow|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340791|NCT00778336|P2|Participant Flow|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
340792|NCT00778336|P1|Participant Flow|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
340793|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
340794|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
340795|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
340796|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
340797|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
340798|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
340799|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
340800|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
340801|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
340802|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
340803|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
340804|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
341003|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340805|NCT00778336|E4|Reported Event|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340806|NCT00778336|E3|Reported Event|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
340807|NCT00778336|E2|Reported Event|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
340808|NCT00778336|E1|Reported Event|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
340809|NCT00778310|B3|Baseline|Total|Total of all reporting groups
340810|NCT00778310|B2|Baseline|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340811|NCT00778310|B1|Baseline|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340812|NCT00778310|P2|Participant Flow|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340813|NCT00778310|P1|Participant Flow|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340814|NCT00778310|O4|Outcome|Children Placebo Condition|This is the BOLD signal data on the Placebo day scan.
340815|NCT00778310|O3|Outcome|Children Drug Condition|This is the BOLD signal data on the Concerta day scan.
340816|NCT00778310|O2|Outcome|Adults Placebo Condition|This is the BOLD signal data on the Placebo day scan.
340817|NCT00778310|O1|Outcome|Adults Drug Condition|This is the BOLD signal data on the Concerta day scan.
340818|NCT00778310|E2|Reported Event|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340819|NCT00778310|E1|Reported Event|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
340820|NCT00778258|B10|Baseline|Total|Total of all reporting groups
340821|NCT00778258|B9|Baseline|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
340822|NCT00778258|B8|Baseline|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
340823|NCT00778258|B7|Baseline|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
340824|NCT00778258|B6|Baseline|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340825|NCT00778258|B5|Baseline|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340826|NCT00778258|B4|Baseline|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340827|NCT00778258|B3|Baseline|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340840|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
340828|NCT00778258|B2|Baseline|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340829|NCT00778258|B1|Baseline|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340830|NCT00778258|P9|Participant Flow|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
340831|NCT00778258|P8|Participant Flow|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
340832|NCT00778258|P7|Participant Flow|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
340833|NCT00778258|P6|Participant Flow|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340834|NCT00778258|P5|Participant Flow|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340835|NCT00778258|P4|Participant Flow|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340836|NCT00778258|P3|Participant Flow|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340837|NCT00778258|P2|Participant Flow|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340838|NCT00778258|P1|Participant Flow|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340839|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
340841|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
340842|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
340843|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
340844|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
340845|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
340846|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
340847|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
340848|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
340849|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
340850|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
340851|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
340852|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
340853|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
340854|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
340855|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
340856|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
340857|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
340858|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
340859|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
340860|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
340861|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
340862|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
340863|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
340864|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
340865|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
340866|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
340867|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
340868|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
340869|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
340870|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
340871|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
340872|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
340873|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
340874|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
340875|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
340876|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
340877|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
340878|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
340879|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
340897|NCT00778167|O2|Outcome|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340898|NCT00778167|O1|Outcome|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340899|NCT00778167|E3|Reported Event|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
340880|NCT00778258|E9|Reported Event|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
340881|NCT00778258|E8|Reported Event|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
340882|NCT00778258|E7|Reported Event|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
340883|NCT00778258|E6|Reported Event|Maintenance - Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340884|NCT00778258|E5|Reported Event|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340885|NCT00778258|E4|Reported Event|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340886|NCT00778258|E3|Reported Event|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340887|NCT00778258|E2|Reported Event|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340888|NCT00778258|E1|Reported Event|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
340889|NCT00778167|B4|Baseline|Total|Total of all reporting groups
340890|NCT00778167|B3|Baseline|Cohort 3|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
340891|NCT00778167|B2|Baseline|Cohort 2|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340892|NCT00778167|B1|Baseline|Cohort 1|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340893|NCT00778167|P3|Participant Flow|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
340894|NCT00778167|P2|Participant Flow|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340895|NCT00778167|P1|Participant Flow|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340896|NCT00778167|O3|Outcome|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
340982|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340983|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340900|NCT00778167|E2|Reported Event|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340901|NCT00778167|E1|Reported Event|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
340902|NCT00778102|B3|Baseline|Total|Total of all reporting groups
340903|NCT00778102|B2|Baseline|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340904|NCT00778102|B1|Baseline|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340905|NCT00778102|P2|Participant Flow|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, irinotecan, leucovorin, and 5-FU (FOLFOXIRI). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340906|NCT00778102|P1|Participant Flow|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX-6). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion; oxaliplatin 85 milligrams per meter-squared (mg/m^2) via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, progressive disease (PD), unacceptable toxicity, or participant refusal.
340907|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340908|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340909|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340910|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340911|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340912|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340913|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340914|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340915|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340916|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340917|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340918|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340919|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340920|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340921|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340922|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340923|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340924|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340925|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340984|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340926|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340927|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340928|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340929|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340930|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340931|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340932|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340933|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340934|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340935|NCT00778102|E2|Reported Event|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340936|NCT00778102|E1|Reported Event|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
340937|NCT00777946|B4|Baseline|Total|Total of all reporting groups
340938|NCT00777946|B3|Baseline|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340939|NCT00777946|B2|Baseline|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340940|NCT00777946|B1|Baseline|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340941|NCT00777946|P3|Participant Flow|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340942|NCT00777946|P2|Participant Flow|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340943|NCT00777946|P1|Participant Flow|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340944|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340945|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340946|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340947|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340948|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340949|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340950|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340951|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340952|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340953|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340954|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340955|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340956|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340957|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340958|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340959|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340960|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340961|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340962|NCT00777946|E3|Reported Event|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
340963|NCT00777946|E2|Reported Event|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340964|NCT00777946|E1|Reported Event|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
340965|NCT00777855|B1|Baseline|Entire Study Population|Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
340966|NCT00777855|P2|Participant Flow|Warfarin+Rifampin First, Then Warfarin Alone|In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
340967|NCT00777855|P1|Participant Flow|Warfarin First, Then Warfarin+Rifampin|In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po.
340968|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
340969|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
340970|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
340971|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
340972|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
340973|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
340974|NCT00777855|E1|Reported Event|Entire Study Population|Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
340975|NCT00777803|B3|Baseline|Total|Total of all reporting groups
340976|NCT00777803|B2|Baseline|OnabotulinumtoxinA (Vistabel®)|
340977|NCT00777803|B1|Baseline|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340978|NCT00777803|P2|Participant Flow|OnabotulinumtoxinA (Vistabel®)|
340979|NCT00777803|P1|Participant Flow|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
340980|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
340981|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
341004|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
341005|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
341006|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
341007|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
341008|NCT00777803|E2|Reported Event|OnabotulinumtoxinA (Vistabel®)|
341009|NCT00777803|E1|Reported Event|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
341010|NCT00777790|B4|Baseline|Total|Total of all reporting groups
341011|NCT00777790|B3|Baseline|Control Group|Meningococcal vaccine-naïve subjects
341012|NCT00777790|B2|Baseline|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
341013|NCT00777790|B1|Baseline|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
341014|NCT00777790|P3|Participant Flow|Control Group|Meningococcal vaccine-naïve subjects
341015|NCT00777790|P2|Participant Flow|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
341016|NCT00777790|P1|Participant Flow|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
341017|NCT00777790|O3|Outcome|Control Group|Meningococcal vaccine-naïve subjects
341018|NCT00777790|O2|Outcome|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
341019|NCT00777790|O1|Outcome|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
341020|NCT00777790|E3|Reported Event|Control Group|Meningococcal vaccine-naïve subjects
341021|NCT00777790|E2|Reported Event|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
341022|NCT00777790|E1|Reported Event|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
341023|NCT00777764|B3|Baseline|Total|Total of all reporting groups
341024|NCT00777764|B2|Baseline|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
341025|NCT00777764|B1|Baseline|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
341026|NCT00777764|P2|Participant Flow|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
341027|NCT00777764|P1|Participant Flow|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
341028|NCT00777764|O1|Outcome|Patients With Allergic Asthma|
341029|NCT00777764|O1|Outcome|Healthy Subjects|
341030|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
341031|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
341074|NCT00777556|E1|Reported Event|DR-104|One tablet for emergency contraception
341075|NCT00777335|B3|Baseline|Total|Total of all reporting groups
341076|NCT00777335|B2|Baseline|Panobinostat Oral|
341077|NCT00777335|B1|Baseline|Panobinostat Intra-venous (i.v.)|
341078|NCT00777335|P2|Participant Flow|Panobinostat Oral|
341079|NCT00777335|P1|Participant Flow|Panobinostat Intra-venous (i.v.)|
341080|NCT00777335|O2|Outcome|Panobinostat Oral|
341081|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
341032|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
341033|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
341034|NCT00777764|E2|Reported Event|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
341035|NCT00777764|E1|Reported Event|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
341036|NCT00777634|B3|Baseline|Total|Total of all reporting groups
341037|NCT00777634|B2|Baseline|Without BED|Individuals who do not meet criteria for binge eating disorder.
341038|NCT00777634|B1|Baseline|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341039|NCT00777634|P2|Participant Flow|Without BED|Individuals who do not meet criteria for binge eating disorder.
341040|NCT00777634|P1|Participant Flow|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341041|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341042|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341043|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341044|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341045|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341046|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341047|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341048|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341049|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341050|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341051|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
341052|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341053|NCT00777634|E2|Reported Event|Without BED|Individuals who do not meet criteria for binge eating disorder.
341054|NCT00777634|E1|Reported Event|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
341055|NCT00777608|B3|Baseline|Total|Total of all reporting groups
341056|NCT00777608|B2|Baseline|Placebo|Participants were randomized to placebo for 84 days
341057|NCT00777608|B1|Baseline|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
341058|NCT00777608|P2|Participant Flow|Placebo|Participants were randomized to placebo for 84 days
341059|NCT00777608|P1|Participant Flow|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
341060|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
341061|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
341062|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
341063|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
341064|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
341065|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
341066|NCT00777608|E2|Reported Event|Placebo|Participants were randomized to placebo for 84 days
341067|NCT00777608|E1|Reported Event|Donezepil 5-10 mg|Participants were randomized to donepezil for 84 days
341068|NCT00777556|B1|Baseline|DR-104|One tablet for emergency contraception
341069|NCT00777556|P1|Participant Flow|DR-104|One tablet for emergency contraception
341070|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
341071|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
341072|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
341073|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
341082|NCT00777335|O2|Outcome|Panobinostat Oral|
341083|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
341084|NCT00777335|E2|Reported Event|Panobinostat Oral|
341085|NCT00777335|E1|Reported Event|Panobinostat Intra-venous (i.v.)|
341086|NCT00777257|B4|Baseline|Total|Total of all reporting groups
341087|NCT00777257|B3|Baseline|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341088|NCT00777257|B2|Baseline|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341089|NCT00777257|B1|Baseline|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341090|NCT00777257|P3|Participant Flow|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341091|NCT00777257|P2|Participant Flow|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341092|NCT00777257|P1|Participant Flow|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341093|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341094|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341095|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341096|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341097|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341098|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341099|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341100|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341101|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341102|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341103|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341104|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341105|NCT00777257|E3|Reported Event|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
341106|NCT00777257|E2|Reported Event|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
341107|NCT00777257|E1|Reported Event|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
341108|NCT00777205|B3|Baseline|Total|Total of all reporting groups
341109|NCT00777205|B2|Baseline|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341110|NCT00777205|B1|Baseline|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341111|NCT00777205|P2|Participant Flow|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341112|NCT00777205|P1|Participant Flow|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
341113|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341114|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
345525|NCT00768599|P3|Participant Flow|Control|Vehicle Foam
341115|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341116|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
341117|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341118|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341119|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341120|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341121|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341122|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341123|NCT00777205|E2|Reported Event|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
341124|NCT00777205|E1|Reported Event|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
341125|NCT00777179|B3|Baseline|Total|Total of all reporting groups
341126|NCT00777179|B2|Baseline|Placebo|Matching Placebo
341127|NCT00777179|B1|Baseline|Vandetanib|Vandetanib 300 mg, orally, once daily
341128|NCT00777179|P2|Participant Flow|Placebo|Matching Placebo
341129|NCT00777179|P1|Participant Flow|Vandetanib|Vandetanib 300 mg, orally, once daily
341130|NCT00777179|O2|Outcome|Placebo|Matching Placebo
341131|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
341132|NCT00777179|O2|Outcome|Placebo|Matching Placebo
341133|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
341134|NCT00777179|O2|Outcome|Placebo|Matching Placebo
341135|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
341136|NCT00777179|O2|Outcome|Placebo|Matching Placebo
341137|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
341138|NCT00777179|O2|Outcome|Placebo|Matching Placebo
341139|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
341140|NCT00777179|E2|Reported Event|Placebo|Matching Placebo
341141|NCT00777179|E1|Reported Event|Vandetanib|Vandetanib 300 mg, orally, once daily
341142|NCT00777153|B4|Baseline|Total|Total of all reporting groups
341143|NCT00777153|B3|Baseline|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341144|NCT00777153|B2|Baseline|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341145|NCT00777153|B1|Baseline|Cediranib 30mg|Cediranib 30mg/Day
341146|NCT00777153|P3|Participant Flow|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341147|NCT00777153|P2|Participant Flow|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341148|NCT00777153|P1|Participant Flow|Cediranib 30mg|Cediranib 30mg/Day
341149|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341150|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 119mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341151|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341152|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341153|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341154|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341155|NCT00777153|O3|Outcome|Lomustine 100mg|Lomustine 110mg/m2/Day + Placebo cediranib
341156|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 100mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341157|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341158|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341159|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341160|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341161|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341162|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341163|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341164|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341165|NCT00777153|O2|Outcome|Cediranib 20mg+ Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341166|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
341167|NCT00777153|E3|Reported Event|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
341168|NCT00777153|E2|Reported Event|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
341169|NCT00777153|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/Day
341170|NCT00777062|B3|Baseline|Total|Total of all reporting groups
341171|NCT00777062|B2|Baseline|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
341172|NCT00777062|B1|Baseline|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
341173|NCT00777062|P2|Participant Flow|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
341174|NCT00777062|P1|Participant Flow|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
341175|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
341176|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
341177|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
341178|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
341179|NCT00777062|E2|Reported Event|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
341180|NCT00777062|E1|Reported Event|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
341181|NCT00777049|B3|Baseline|Total|Total of all reporting groups
341182|NCT00777049|B2|Baseline|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341183|NCT00777049|B1|Baseline|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341184|NCT00777049|P2|Participant Flow|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341185|NCT00777049|P1|Participant Flow|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341186|NCT00777049|O2|Outcome|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341187|NCT00777049|O1|Outcome|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341188|NCT00777049|E2|Reported Event|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341189|NCT00777049|E1|Reported Event|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
341190|NCT00777023|B4|Baseline|Total|Total of all reporting groups
341191|NCT00777023|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
341192|NCT00777023|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341193|NCT00777023|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341194|NCT00777023|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
341195|NCT00777023|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341196|NCT00777023|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341197|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
341198|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341199|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341200|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
341201|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341202|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341203|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
341204|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341205|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341206|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
341207|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341208|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341209|NCT00777023|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
341210|NCT00777023|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
341211|NCT00777023|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
341212|NCT00776997|B1|Baseline|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341213|NCT00776997|P1|Participant Flow|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341214|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341215|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341216|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341217|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341218|NCT00776997|E1|Reported Event|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
341219|NCT00776984|B3|Baseline|Total|Total of all reporting groups
341220|NCT00776984|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341221|NCT00776984|B1|Baseline|Placebo|Patients treated with matching placebo
341222|NCT00776984|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341223|NCT00776984|P1|Participant Flow|Placebo|Patients treated with matching placebo
341224|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341225|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341226|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341227|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341228|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341229|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341230|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341231|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341232|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341233|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341234|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341235|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341236|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341237|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341238|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341239|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341240|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341241|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341242|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341243|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341244|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341245|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341246|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341247|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341248|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341249|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341250|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341251|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341252|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341253|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341254|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341255|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341256|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341257|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341258|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341259|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341260|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341261|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341262|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341263|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341264|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341265|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341266|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341267|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341268|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341269|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341270|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341271|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341272|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341273|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341274|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341275|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341276|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341277|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341278|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341279|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341280|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341281|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341282|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341283|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341284|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341285|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341286|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341287|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341288|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341289|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
341290|NCT00776984|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341291|NCT00776984|E1|Reported Event|Placebo|Patients treated with matching placebo
341292|NCT00776919|B5|Baseline|Total|Total of all reporting groups
341293|NCT00776919|B4|Baseline|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341294|NCT00776919|B3|Baseline|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341295|NCT00776919|B2|Baseline|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341296|NCT00776919|B1|Baseline|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341297|NCT00776919|P4|Participant Flow|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341298|NCT00776919|P3|Participant Flow|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341299|NCT00776919|P2|Participant Flow|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341300|NCT00776919|P1|Participant Flow|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341301|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341302|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341303|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341304|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341305|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341306|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341307|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341308|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341309|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341310|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341311|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341312|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341313|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341314|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341315|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341316|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341317|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341318|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341319|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341320|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341321|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341322|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341323|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341324|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341325|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341326|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341327|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341328|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341329|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341330|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341331|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341332|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341333|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341334|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341335|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341336|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341337|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341338|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341339|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341340|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341341|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341502|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341342|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341343|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341344|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341345|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341346|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341347|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341348|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341349|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341350|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341351|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341352|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341353|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341354|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341355|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341356|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341357|NCT00776919|E4|Reported Event|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341358|NCT00776919|E3|Reported Event|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341359|NCT00776919|E2|Reported Event|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341360|NCT00776919|E1|Reported Event|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
341361|NCT00776789|B3|Baseline|Total|Total of all reporting groups
341362|NCT00776789|B2|Baseline|Control Group|baby will be kept by the mothers side and not given skin to skin contact
341363|NCT00776789|B1|Baseline|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341364|NCT00776789|P2|Participant Flow|Control Group|baby will be kept by the mothers side and not given skin to skin contact
341365|NCT00776789|P1|Participant Flow|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341366|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
341367|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341368|NCT00776789|O2|Outcome|Control Group|Babies will be kept by the mothers side and not given skin to skin contact
341369|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341370|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
341371|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341372|NCT00776789|O2|Outcome|Control Group|Baby will be kept by the mothers side and not given skin to skin contact
341373|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341374|NCT00776789|E2|Reported Event|Control Group|baby will be kept by the mothers side and not given skin to skin contact
341375|NCT00776789|E1|Reported Event|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
341376|NCT00776659|B1|Baseline|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341377|NCT00776659|P1|Participant Flow|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341378|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341379|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341380|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341381|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341382|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341383|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341384|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341385|NCT00776659|E1|Reported Event|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
341386|NCT00776594|B3|Baseline|Total|Total of all reporting groups
341387|NCT00776594|B2|Baseline|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341388|NCT00776594|B1|Baseline|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341389|NCT00776594|P2|Participant Flow|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341390|NCT00776594|P1|Participant Flow|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341391|NCT00776594|O2|Outcome|Leptin in Patients Treated With ADT Alone|Leptin in patients with sample available treated with ADT alone
341392|NCT00776594|O1|Outcome|Leptin Level in Patients Treated With ADT+Bev|Leptin level in patients with sample available treated with ADT+bev
341393|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341394|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341395|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341396|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341397|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341398|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341399|NCT00776594|E2|Reported Event|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
341400|NCT00776594|E1|Reported Event|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
341401|NCT00776555|B3|Baseline|Total|Total of all reporting groups
341402|NCT00776555|B2|Baseline|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341403|NCT00776555|B1|Baseline|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
343165|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
341404|NCT00776555|P2|Participant Flow|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341405|NCT00776555|P1|Participant Flow|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
341406|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341407|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
341408|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341409|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
341410|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341411|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
341412|NCT00776555|E2|Reported Event|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
341413|NCT00776555|E1|Reported Event|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
341414|NCT00776295|B1|Baseline|p53 Vaccination|Dendritic cell p53 vaccination
341415|NCT00776295|P1|Participant Flow|p53 Vaccination|Dendritic cell p53 vaccination
341416|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
341417|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
341418|NCT00776295|E1|Reported Event|Biological/Vaccine|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
341419|NCT00776230|B4|Baseline|Total|Total of all reporting groups
341420|NCT00776230|B3|Baseline|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
341421|NCT00776230|B2|Baseline|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
341422|NCT00776230|B1|Baseline|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
341423|NCT00776230|P3|Participant Flow|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
341424|NCT00776230|P2|Participant Flow|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
341425|NCT00776230|P1|Participant Flow|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
341426|NCT00776230|O3|Outcome|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
341427|NCT00776230|O2|Outcome|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
341428|NCT00776230|O1|Outcome|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
341429|NCT00776230|E3|Reported Event|IC51 Cohort 3|
341430|NCT00776230|E2|Reported Event|IC51 Cohort 2|
341431|NCT00776230|E1|Reported Event|IC51 Cohort 1|
341432|NCT00776009|B7|Baseline|Total|Total of all reporting groups
341433|NCT00776009|B6|Baseline|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
341434|NCT00776009|B5|Baseline|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
341435|NCT00776009|B4|Baseline|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
341436|NCT00776009|B3|Baseline|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
341437|NCT00776009|B2|Baseline|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
341438|NCT00776009|B1|Baseline|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
341503|NCT00775944|E4|Reported Event|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341439|NCT00776009|P6|Participant Flow|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
341440|NCT00776009|P5|Participant Flow|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
341441|NCT00776009|P4|Participant Flow|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
341442|NCT00776009|P3|Participant Flow|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
341443|NCT00776009|P2|Participant Flow|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
341444|NCT00776009|P1|Participant Flow|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
341445|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341446|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341447|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341448|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341449|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341450|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341451|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341452|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341453|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341454|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341455|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341456|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341457|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341458|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341459|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341460|NCT00776009|E3|Reported Event|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
341461|NCT00776009|E2|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
341462|NCT00776009|E1|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
341463|NCT00775983|B3|Baseline|Total|Total of all reporting groups
341464|NCT00775983|B2|Baseline|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
341465|NCT00775983|B1|Baseline|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
341504|NCT00775944|E3|Reported Event|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341505|NCT00775944|E2|Reported Event|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341466|NCT00775983|P2|Participant Flow|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
341467|NCT00775983|P1|Participant Flow|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
341468|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
341469|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
341470|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
341471|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
341472|NCT00775983|E2|Reported Event|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
341473|NCT00775983|E1|Reported Event|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
341474|NCT00775944|B5|Baseline|Total|Total of all reporting groups
341475|NCT00775944|B4|Baseline|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341476|NCT00775944|B3|Baseline|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341477|NCT00775944|B2|Baseline|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341478|NCT00775944|B1|Baseline|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341479|NCT00775944|P4|Participant Flow|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341480|NCT00775944|P3|Participant Flow|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341481|NCT00775944|P2|Participant Flow|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341482|NCT00775944|P1|Participant Flow|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341483|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341484|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341485|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341486|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341487|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341488|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341489|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341490|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341491|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341492|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341493|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341494|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341495|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341496|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341497|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341498|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341499|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
341500|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
341501|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
341551|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341506|NCT00775944|E1|Reported Event|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
341507|NCT00775671|B3|Baseline|Total|Total of all reporting groups
341508|NCT00775671|B2|Baseline|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
341509|NCT00775671|B1|Baseline|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
341510|NCT00775671|P2|Participant Flow|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
341511|NCT00775671|P1|Participant Flow|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
341512|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
341513|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
341514|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
341515|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
341516|NCT00775671|E2|Reported Event|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
341517|NCT00775671|E1|Reported Event|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
341518|NCT00775606|B3|Baseline|Total|Total of all reporting groups
341519|NCT00775606|B2|Baseline|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341520|NCT00775606|B1|Baseline|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341521|NCT00775606|P2|Participant Flow|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341522|NCT00775606|P1|Participant Flow|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341523|NCT00775606|O2|Outcome|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341524|NCT00775606|O1|Outcome|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341525|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341526|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341527|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341528|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341529|NCT00775606|E2|Reported Event|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
341530|NCT00775606|E1|Reported Event|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
341531|NCT00775593|B1|Baseline|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
341532|NCT00775593|P1|Participant Flow|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
341533|NCT00775593|O1|Outcome|Study Group|Evaluable patients
341534|NCT00775593|O1|Outcome|Study Group|Evaluable patients
341535|NCT00775593|O1|Outcome|Study Group|Evaluable patients
341536|NCT00775593|O1|Outcome|Study Group|Evaluable patients
341537|NCT00775593|E1|Reported Event|Study Group|Evaluable patients
341538|NCT00775528|B1|Baseline|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341539|NCT00775528|P1|Participant Flow|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341540|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341541|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341542|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341543|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341544|NCT00775528|E1|Reported Event|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
341545|NCT00775463|B3|Baseline|Total|Total of all reporting groups
341546|NCT00775463|B2|Baseline|Treprostinil Diethanolamine|intent to treat population
341547|NCT00775463|B1|Baseline|Placebo|intent to treat population
341548|NCT00775463|P2|Participant Flow|Treprostinil Diethanolamine|All subejcts who recieved at least one dose of study drug. One subject in the treprostinil diethanolamine treatment group was randomized, withdrew consent and exited the study prior to taking any study medication and is not included in the analysis summary.
341549|NCT00775463|P1|Participant Flow|Placebo|All subjects who recieved at least one dose of study drug.
341550|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341552|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341553|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341554|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341555|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341556|NCT00775463|O6|Outcome|Treprostinil Diethanolamine- Overall Disease Status Response|Treprostinil diethanolamine intent to treat population
341557|NCT00775463|O5|Outcome|Placebo- Overall Disease Status Response|Placebo intent to treat population
341558|NCT00775463|O4|Outcome|Treprostinil Diethanolamine- Raynaud's Phenomenon Response|Treprostinil diethanolamine intent to treat population
341559|NCT00775463|O3|Outcome|Placebo- Raynaud's Phenomenon Response|Placebo intent to treat population
341560|NCT00775463|O2|Outcome|Treprostinil Diethanolamine- Digital Ulcer Response|Treprostinil diethanolamine intent to treat population
341561|NCT00775463|O1|Outcome|Placebo- Digital Ulcer Response|Placebo intent to treat population
341562|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341563|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341564|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341565|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341566|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341567|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341568|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341569|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341570|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341571|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341572|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341573|NCT00775463|O1|Outcome|Placebo|placebo intent to treat population
341574|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341575|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341576|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
341577|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
341578|NCT00775463|E2|Reported Event|Treprostinil Diethanolamine|
341579|NCT00775463|E1|Reported Event|Placebo|
341580|NCT00775450|B6|Baseline|Total|Total of all reporting groups
341581|NCT00775450|B5|Baseline|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341582|NCT00775450|B4|Baseline|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341583|NCT00775450|B3|Baseline|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341584|NCT00775450|B2|Baseline|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341585|NCT00775450|B1|Baseline|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341586|NCT00775450|P5|Participant Flow|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341587|NCT00775450|P4|Participant Flow|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341588|NCT00775450|P3|Participant Flow|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341589|NCT00775450|P2|Participant Flow|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341590|NCT00775450|P1|Participant Flow|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341591|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341592|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341593|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341594|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341595|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341596|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341597|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341598|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
343166|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341599|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341600|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341601|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341602|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341603|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341604|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341605|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341606|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341607|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341608|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341609|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341610|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341611|NCT00775450|E5|Reported Event|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
341612|NCT00775450|E4|Reported Event|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
341613|NCT00775450|E3|Reported Event|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
341614|NCT00775450|E2|Reported Event|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
341615|NCT00775450|E1|Reported Event|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
341616|NCT00775437|B1|Baseline|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341617|NCT00775437|P1|Participant Flow|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341618|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341619|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341620|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341621|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341622|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341623|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341624|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341625|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341626|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341627|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341628|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341629|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341630|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341631|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341632|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341633|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341634|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341635|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341636|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341720|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
345526|NCT00768599|P2|Participant Flow|Test Drug|Econazole Nitrate Foam 1%
341637|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341638|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341639|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341640|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341641|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341642|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341643|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341644|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341645|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341646|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341647|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341648|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341649|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341650|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
342208|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
341651|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341652|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341653|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341654|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341655|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341656|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341657|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341658|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341659|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341660|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341661|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341662|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341663|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341664|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
342209|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
341665|NCT00775437|E1|Reported Event|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
341666|NCT00775411|B1|Baseline|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341667|NCT00775411|P1|Participant Flow|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341668|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341669|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341670|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341671|NCT00775411|E1|Reported Event|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
341672|NCT00775346|B1|Baseline|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
341673|NCT00775346|P1|Participant Flow|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
341674|NCT00775346|O1|Outcome|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
341675|NCT00775346|E1|Reported Event|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
341676|NCT00775229|B3|Baseline|Total|Total of all reporting groups
341677|NCT00775229|B2|Baseline|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341678|NCT00775229|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341679|NCT00775229|P2|Participant Flow|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341680|NCT00775229|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341681|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341682|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341683|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341684|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341685|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341686|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341687|NCT00775229|E2|Reported Event|Placebo|"Placebo~Placebo : pill, by mouth, daily"
341688|NCT00775229|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
341689|NCT00775203|B3|Baseline|Total|Total of all reporting groups
341690|NCT00775203|B2|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341691|NCT00775203|B1|Baseline|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341692|NCT00775203|P2|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341693|NCT00775203|P1|Participant Flow|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341694|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341695|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341696|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341697|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341698|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
345540|NCT00768599|O3|Outcome|Control|Vehicle Foam
341699|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341700|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341701|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341702|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341703|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341704|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341705|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341706|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341707|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341708|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341709|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341710|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341711|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341712|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341713|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341714|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341715|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341716|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341717|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341718|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341719|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
343167|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
341721|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341722|NCT00775203|E2|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
341723|NCT00775203|E1|Reported Event|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
341724|NCT00775021|B1|Baseline|Total Participants|Total number of participants that completed the study.
341725|NCT00775021|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A contact lens worn first and etafilcon A contact lens second.
341726|NCT00775021|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A contact lens worn first and nelfilcon A contact lens worn second
341727|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
341728|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
341729|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
341730|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
341731|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
341732|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
341733|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
341734|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
341735|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
341736|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
341737|NCT00775021|E2|Reported Event|Nelfilcon A|nelfilcon A contact lenses.
341738|NCT00775021|E1|Reported Event|Etafilcon A|etafilcon A contact lenses
341739|NCT00774995|B5|Baseline|Total|Total of all reporting groups
341740|NCT00774995|B4|Baseline|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341741|NCT00774995|B3|Baseline|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341742|NCT00774995|B2|Baseline|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341743|NCT00774995|B1|Baseline|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341744|NCT00774995|P4|Participant Flow|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341745|NCT00774995|P3|Participant Flow|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341746|NCT00774995|P2|Participant Flow|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341747|NCT00774995|P1|Participant Flow|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341748|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341749|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341750|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341751|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341752|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341753|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341754|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
343168|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
341755|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341756|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341757|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341758|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341759|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341760|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341761|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341762|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341763|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341764|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341765|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341766|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341767|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341768|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341769|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341770|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341771|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341772|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341773|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341774|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341775|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341776|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341777|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341778|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341779|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341780|NCT00774995|E4|Reported Event|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341781|NCT00774995|E3|Reported Event|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
343002|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
341782|NCT00774995|E2|Reported Event|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341783|NCT00774995|E1|Reported Event|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
341784|NCT00774930|B3|Baseline|Total|Total of all reporting groups
341785|NCT00774930|B2|Baseline|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
341786|NCT00774930|B1|Baseline|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
341787|NCT00774930|P2|Participant Flow|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
341788|NCT00774930|P1|Participant Flow|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.
341789|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341790|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341791|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341792|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341793|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341794|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341795|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341796|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341797|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341798|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341799|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341800|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341801|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341802|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341803|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341804|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341805|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341806|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341807|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
341808|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
341809|NCT00774930|E4|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)|All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
341810|NCT00774930|E3|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)|All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
341811|NCT00774930|E2|Reported Event|Placebo (DB Phase)|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
341812|NCT00774930|E1|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
341813|NCT00774852|B3|Baseline|Total|Total of all reporting groups
341896|NCT00774748|O1|Outcome|Once Daily Dosing|10 participants were placed on an once daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage. 11 participants were placed on an twice daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage.
341814|NCT00774852|B2|Baseline|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341815|NCT00774852|B1|Baseline|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341816|NCT00774852|P2|Participant Flow|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341817|NCT00774852|P1|Participant Flow|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341818|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
341819|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
341820|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
341821|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
341822|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
341823|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
341824|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341825|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341897|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily.
341898|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily LMWH.
341826|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341827|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341828|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341829|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341830|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341831|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341832|NCT00774852|O6|Outcome|Week 24 No Response: Placebo|At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
341833|NCT00774852|O5|Outcome|Week 24 No Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
341834|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
341835|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
341836|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
341837|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
341899|NCT00774748|O1|Outcome|All Participants|Both dosing schedules, once and twice daily, all participants.
345541|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
341838|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341839|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341840|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341841|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341842|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341843|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341844|NCT00774852|O2|Outcome|Week 24 Non-Responder Who Continued Treatment: Placebo|Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
341845|NCT00774852|O1|Outcome|Week 24 Non-Responder Who Continued Treatment: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
341846|NCT00774852|O2|Outcome|Week 24 Non-Responder: Placebo|Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
341847|NCT00774852|O1|Outcome|Week 24 Non-Responder: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
341871|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
341872|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
345542|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
341848|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341849|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341850|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341851|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341852|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
341853|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
341854|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
341855|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
341856|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
341857|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
341858|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341859|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341894|NCT00774748|P1|Participant Flow|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
341860|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341861|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341862|NCT00774852|E2|Reported Event|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
341863|NCT00774852|E1|Reported Event|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
341864|NCT00774800|B1|Baseline|Overall Study|"Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days [d]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)~Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered~Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)~Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered"
341865|NCT00774800|P1|Participant Flow|First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R|"Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.~Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.~Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.~Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.~Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was <160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.~All dose finding visits and interventions were separated by 3-10 days."
341866|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
341867|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
341868|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
341869|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
341870|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
341895|NCT00774748|O1|Outcome|All Participants|All participants on both a daily and twice daily dosing schedule
345543|NCT00768599|O3|Outcome|Control|Vehicle Foam
341873|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
341874|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
341875|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
341876|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
341877|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
341878|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
341879|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
341880|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
341881|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
341882|NCT00774800|E4|Reported Event|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
341883|NCT00774800|E3|Reported Event|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
341884|NCT00774800|E2|Reported Event|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
341885|NCT00774800|E1|Reported Event|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
341886|NCT00774787|B1|Baseline|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341887|NCT00774787|P1|Participant Flow|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341888|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341889|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341890|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341891|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341892|NCT00774787|E1|Reported Event|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
341893|NCT00774748|B1|Baseline|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
341900|NCT00774748|E1|Reported Event|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
341901|NCT00774397|B8|Baseline|Total|Total of all reporting groups
341902|NCT00774397|B7|Baseline|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341903|NCT00774397|B6|Baseline|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341904|NCT00774397|B5|Baseline|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341905|NCT00774397|B4|Baseline|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341906|NCT00774397|B3|Baseline|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341907|NCT00774397|B2|Baseline|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341908|NCT00774397|B1|Baseline|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341909|NCT00774397|P7|Participant Flow|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341910|NCT00774397|P6|Participant Flow|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341911|NCT00774397|P5|Participant Flow|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341912|NCT00774397|P4|Participant Flow|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341913|NCT00774397|P3|Participant Flow|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341914|NCT00774397|P2|Participant Flow|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341915|NCT00774397|P1|Participant Flow|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341916|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341917|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341918|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341919|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341920|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
343048|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
341921|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341922|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341923|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341924|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341925|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341926|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341927|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341928|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341929|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341930|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341931|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341932|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341933|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341934|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341935|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341936|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341937|NCT00774397|O6|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341938|NCT00774397|O5|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341939|NCT00774397|O4|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341940|NCT00774397|O3|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341941|NCT00774397|O2|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341942|NCT00774397|O1|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341943|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341944|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341945|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341946|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341947|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341948|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341949|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341950|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341951|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341952|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341953|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341954|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341955|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341956|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341957|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341958|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341959|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341960|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341961|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342206|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
341962|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341963|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341964|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341965|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341966|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341967|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341968|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341969|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341970|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341971|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341972|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341973|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341974|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341975|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341976|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341977|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341978|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341979|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341980|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341981|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341982|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341983|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341984|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341985|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341986|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341987|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341988|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341989|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341990|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341991|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341992|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341993|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341994|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341995|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341996|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341997|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341998|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
341999|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342000|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342001|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342002|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342003|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342004|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342005|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342006|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342007|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342008|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342009|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342010|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342011|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342012|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342013|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342014|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342015|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342016|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342017|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342018|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342019|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342020|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342021|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342022|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342023|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342024|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342025|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342026|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342027|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342028|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342029|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342030|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342031|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342032|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342033|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342034|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342035|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342036|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342037|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342038|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342039|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342040|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342041|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342042|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342043|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342044|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342045|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342046|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342047|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342048|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342049|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342050|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342051|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342052|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342053|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342054|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342055|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342056|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342057|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342058|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342059|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342060|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342061|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342062|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342063|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342064|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342065|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342066|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342067|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342068|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342069|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342070|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342071|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342072|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342073|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342074|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342075|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342076|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342077|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342078|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342079|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342080|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342081|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342082|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342083|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342084|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342085|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342086|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342087|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342088|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342089|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342090|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342091|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342092|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342093|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342094|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342095|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342096|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342097|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342098|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342099|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342100|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342101|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342102|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342103|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342104|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342105|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342106|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342107|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342108|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342109|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342110|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342111|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342112|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342113|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342114|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342115|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342116|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342117|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342118|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342119|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342120|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342121|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342122|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342123|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342124|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342125|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342126|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342127|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342128|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342129|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342130|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342131|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342132|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342133|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342134|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342135|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342136|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342137|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342138|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342139|NCT00774397|E7|Reported Event|240mg BID/LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342140|NCT00774397|E6|Reported Event|240mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342141|NCT00774397|E5|Reported Event|240mg QD/LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342142|NCT00774397|E4|Reported Event|240mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342143|NCT00774397|E3|Reported Event|240mg QD/LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342144|NCT00774397|E2|Reported Event|120mg QD/LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342145|NCT00774397|E1|Reported Event|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
342146|NCT00774306|B5|Baseline|Total|Total of all reporting groups
342147|NCT00774306|B4|Baseline|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
342148|NCT00774306|B3|Baseline|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
342149|NCT00774306|B2|Baseline|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
342150|NCT00774306|B1|Baseline|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses."
342151|NCT00774306|P4|Participant Flow|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
342152|NCT00774306|P3|Participant Flow|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
342207|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342153|NCT00774306|P2|Participant Flow|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
342154|NCT00774306|P1|Participant Flow|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.~x~x"
342155|NCT00774306|O4|Outcome|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
342156|NCT00774306|O3|Outcome|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
342157|NCT00774306|O2|Outcome|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
342158|NCT00774306|O1|Outcome|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
342159|NCT00774306|E4|Reported Event|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
342160|NCT00774306|E3|Reported Event|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
342161|NCT00774306|E2|Reported Event|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
342162|NCT00774306|E1|Reported Event|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
342163|NCT00774267|B5|Baseline|Total|Total of all reporting groups
342164|NCT00774267|B4|Baseline|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342165|NCT00774267|B3|Baseline|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342166|NCT00774267|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342167|NCT00774267|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342168|NCT00774267|P4|Participant Flow|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342169|NCT00774267|P3|Participant Flow|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342170|NCT00774267|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342171|NCT00774267|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342172|NCT00774267|O4|Outcome|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342173|NCT00774267|O3|Outcome|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342174|NCT00774267|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
343091|NCT00772629|O1|Outcome|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
342175|NCT00774267|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342176|NCT00774267|E4|Reported Event|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342177|NCT00774267|E3|Reported Event|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342178|NCT00774267|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342179|NCT00774267|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
342180|NCT00774163|B3|Baseline|Total|Total of all reporting groups
342181|NCT00774163|B2|Baseline|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342182|NCT00774163|B1|Baseline|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342183|NCT00774163|P2|Participant Flow|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342184|NCT00774163|P1|Participant Flow|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342185|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342186|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342187|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342188|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342189|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342190|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342191|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342192|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342193|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342194|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342195|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342196|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342197|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342198|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342199|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342200|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342201|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342202|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342203|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342204|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342205|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
343157|NCT00772538|P1|Participant Flow|Placebo|Patients treated with matching placebo
342210|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342211|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342212|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342213|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342214|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342215|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342216|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342217|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342218|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342219|NCT00774163|E2|Reported Event|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
342220|NCT00774163|E1|Reported Event|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
342221|NCT00774046|B1|Baseline|All Patients|Ara-C Mitoxantrone Etoposide
342222|NCT00774046|P1|Participant Flow|Induction Chemotherapy Followed by Stem Cell Transplant|Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
342223|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342224|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342225|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342226|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342227|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342228|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342229|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
342230|NCT00774046|E1|Reported Event|All Patients|Ara-C Mitoxantrone Etoposide
342231|NCT00773968|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342232|NCT00773968|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant’s hemoglobin (Hb) value.
342233|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342234|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342235|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342236|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342237|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342238|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342269|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
343158|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
342239|NCT00773968|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
342240|NCT00773955|B1|Baseline|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342241|NCT00773955|P1|Participant Flow|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342242|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342243|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342244|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342245|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342246|NCT00773955|E1|Reported Event|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
342247|NCT00773786|B1|Baseline|All Study Participants|Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
342248|NCT00773786|P2|Participant Flow|Placebo, Then Arformoterol (Brovana)|Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
342249|NCT00773786|P1|Participant Flow|Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo|Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
342250|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week
342251|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
342252|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
342253|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
342254|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
342255|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
342256|NCT00773786|E2|Reported Event|Placebo|Placebo twice daily for 1 week
342257|NCT00773786|E1|Reported Event|Arformoterol|Arformoterol twice daily for 1 week via nebulizer
342258|NCT00773734|B5|Baseline|Total|Total of all reporting groups
342259|NCT00773734|B4|Baseline|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342260|NCT00773734|B3|Baseline|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342261|NCT00773734|B2|Baseline|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342262|NCT00773734|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
342263|NCT00773734|P6|Participant Flow|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342264|NCT00773734|P5|Participant Flow|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342265|NCT00773734|P4|Participant Flow|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342266|NCT00773734|P3|Participant Flow|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342267|NCT00773734|P2|Participant Flow|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).
342268|NCT00773734|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
343159|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
345544|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
342270|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342271|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342272|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342273|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342274|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342275|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342276|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342277|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342278|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342279|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342280|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342281|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342282|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342283|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342284|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342285|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342286|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342287|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342288|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342289|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342290|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342291|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342292|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342293|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342294|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342295|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342296|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342297|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342298|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342299|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342300|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342301|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342302|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342303|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342304|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342413|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342879|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342880|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342305|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342306|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342307|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342308|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342309|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342310|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342311|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342312|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342313|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342314|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342315|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342316|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342317|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342318|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342319|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342500|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
342833|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342320|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342321|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342322|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342323|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342324|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342325|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342326|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342327|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342328|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342329|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342330|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342331|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342332|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342333|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342334|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342720|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342721|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342335|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342336|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342337|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342338|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342339|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342340|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342341|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342342|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342343|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342344|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342345|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342346|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342347|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342348|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342349|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342722|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342723|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342954|NCT00772954|B4|Baseline|Total|Total of all reporting groups
342350|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342351|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342352|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342353|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342354|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342355|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342356|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342357|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342358|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342359|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342360|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342361|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342362|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342363|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342364|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342365|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342366|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342367|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342368|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342369|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342370|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342371|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342372|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342373|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342374|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342375|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342376|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342377|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342378|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342379|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342380|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342381|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342382|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342383|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342384|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342385|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342386|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342387|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342388|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342724|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
342389|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342390|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342391|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342392|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342393|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342394|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342395|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
342396|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342397|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
342398|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342399|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342400|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
342401|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342402|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
342403|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342404|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342405|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
342406|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342407|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
342408|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342409|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342410|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
342411|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342412|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
342414|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342415|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342416|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342417|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342418|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342419|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342420|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342421|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342422|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342423|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342424|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342425|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342426|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342427|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342428|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342429|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342725|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342430|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342431|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342432|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342433|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342434|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342435|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342436|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342437|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342438|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342439|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342440|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342441|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342442|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342443|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342444|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342726|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342727|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
345545|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
342445|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342446|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342447|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342448|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342449|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342450|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342451|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342452|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342453|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342454|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342455|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342456|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342457|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342458|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342459|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342728|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342729|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
343160|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
342460|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342461|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342462|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342463|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342464|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342465|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342466|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342467|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342468|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342469|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342470|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342471|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342472|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342473|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342474|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342730|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342731|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342732|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342475|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342476|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342477|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342478|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342479|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342480|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342481|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
342482|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342483|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342484|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342485|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342486|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342487|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342488|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342489|NCT00773734|O1|Outcome|Placebo BID|.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342490|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342491|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342492|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342493|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)
342494|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342495|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342496|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
342497|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342498|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342499|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342501|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342502|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342503|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342504|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342505|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342506|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342507|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342508|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342509|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342510|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342511|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342512|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342513|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342514|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342515|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342733|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342734|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
345546|NCT00768599|E3|Reported Event|Control|Vehicle Foam
342516|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342517|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342518|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342519|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342520|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342521|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342522|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342523|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342524|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342525|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342526|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342527|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342528|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342529|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342530|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342735|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342736|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342872|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
343161|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
342531|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342532|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342533|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342534|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342535|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342536|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342537|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342538|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342539|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342540|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342541|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342542|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342543|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342544|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342545|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342760|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342761|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
345547|NCT00768599|E2|Reported Event|Test Drug|Econazole Nitrate Foam 1%
342546|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342547|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342548|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342549|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342550|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342551|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342552|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342553|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342554|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342555|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342556|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342557|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342558|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342559|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342560|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342762|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).
342763|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342873|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
343162|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
342561|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342562|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342563|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342564|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342565|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342566|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342567|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342568|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342569|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342570|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342571|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342572|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342573|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342574|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342575|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342791|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342792|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
345604|NCT00768300|B3|Baseline|Total|Total of all reporting groups
342576|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342577|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342578|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342579|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342580|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342581|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342582|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342583|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342584|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342585|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342586|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342587|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342588|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342589|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342590|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342793|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342794|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342874|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
343163|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
342591|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342592|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342593|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342594|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342595|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342596|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342597|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342598|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342599|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342600|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342601|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342602|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342603|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342604|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342605|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342820|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342821|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342822|NCT00773734|E7|Reported Event|Apremilast 30mg BID (APR Exposure Period) Years 0-6|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
342606|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342607|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342608|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342609|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342610|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342611|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342612|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342613|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342614|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342615|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342616|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342617|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342618|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342619|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342620|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342823|NCT00773734|E6|Reported Event|Apremilast 20mg BID (APR Exposure Period) Years 0-6|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
342824|NCT00773734|E5|Reported Event|Apremilast 10mg BID (APR Exposure Period) Years 0-6|Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).
342621|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342622|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342623|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342624|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342625|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342626|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342627|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342628|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342629|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342630|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342631|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342632|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342633|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342634|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342635|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342825|NCT00773734|E4|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
342826|NCT00773734|E3|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
342827|NCT00773734|E2|Reported Event|Apremilast 10mg BID (Weeks 0-16)|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
343164|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
342636|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342637|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342638|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342639|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342640|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342641|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342642|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342643|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342644|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342645|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342646|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342647|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342648|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342649|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342650|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342828|NCT00773734|E1|Reported Event|Placebo (Weeks 0-16)|Participants randomized to placebo PO BID during the Placebo-controlled Phase
342829|NCT00773474|B1|Baseline|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
346159|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
342651|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342652|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342653|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342654|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342655|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342656|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342657|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342658|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342659|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342660|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342661|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342662|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342663|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342664|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342665|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342830|NCT00773474|P1|Participant Flow|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342875|NCT00773461|E2|Reported Event|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342666|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342667|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342668|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342669|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342670|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342671|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342672|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342673|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342674|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342675|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342676|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342677|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342678|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342679|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342680|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342831|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342876|NCT00773461|E1|Reported Event|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342681|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342682|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342683|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342684|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342685|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342686|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342687|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342688|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342689|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342690|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342691|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342692|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342693|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342694|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342695|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342832|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342877|NCT00773383|B1|Baseline|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342696|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342697|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342698|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342699|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342700|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
342701|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342702|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342703|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342704|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342705|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342706|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342707|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342708|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342709|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342710|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342711|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342712|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342713|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
342714|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
342715|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342716|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342717|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342718|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342719|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
342878|NCT00773383|P1|Participant Flow|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342737|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342738|NCT00773734|O4|Outcome|Placebo-Apremilast (APR) 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342739|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342740|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342741|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342742|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342743|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342744|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342745|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342746|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342747|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342748|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342749|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342750|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342751|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342752|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342753|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342754|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342755|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342756|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342757|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342758|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342759|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342764|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342765|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342766|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342767|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342768|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342769|NCT00773734|O4|Outcome|Apremilast 30 mg|Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342770|NCT00773734|O3|Outcome|Apremilast 20mg|Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342771|NCT00773734|O2|Outcome|Apremilast 10mg|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342772|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342773|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
342774|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
342775|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342776|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342777|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342778|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342779|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342780|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342781|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .
342782|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342783|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342784|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342785|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
342786|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
342787|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342788|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342789|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342790|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
346160|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
342795|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342796|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
342797|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
342798|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
342799|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342800|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342801|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342802|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342803|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
342804|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
342805|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
342806|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342807|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
342808|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
342809|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342810|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342811|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
342812|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).
342813|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
342814|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).
342815|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342816|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342817|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).
342818|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
342819|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
342834|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342835|NCT00773474|E1|Reported Event|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
342836|NCT00773461|B3|Baseline|Total|Total of all reporting groups
342837|NCT00773461|B2|Baseline|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342838|NCT00773461|B1|Baseline|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342839|NCT00773461|P2|Participant Flow|Tocilizumab + DMARDs|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
342840|NCT00773461|P1|Participant Flow|Placebo + DMARDs|Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
342841|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342842|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342843|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342844|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342845|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342846|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342847|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342848|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342849|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342850|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342851|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342852|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342853|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342854|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342855|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342856|NCT00773461|O1|Outcome|Placebo+DMARD|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342857|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342858|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342859|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342860|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342861|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342862|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342863|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342864|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342865|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342866|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342867|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342868|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342869|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342870|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
342871|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
346161|NCT00766415|E2|Reported Event|Placebo|Placebo, twice daily
342881|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342882|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342883|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342884|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342885|NCT00773383|O4|Outcome|R1507_Baseline Missing|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
342886|NCT00773383|O3|Outcome|R1507_Baseline Diabetes Mellitus|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL"
342887|NCT00773383|O2|Outcome|R1507_Baseline Impaired Fasting Glucose|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 110 to < 126 mg/dL"
342888|NCT00773383|O1|Outcome|R1507_Baseline Glucose Normal|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline < 110 mg/dL."
342889|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342890|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342891|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342892|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342893|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342894|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342895|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342896|NCT00773383|E1|Reported Event|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
342897|NCT00773370|B3|Baseline|Total|Total of all reporting groups
342898|NCT00773370|B2|Baseline|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342899|NCT00773370|B1|Baseline|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342900|NCT00773370|P2|Participant Flow|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342901|NCT00773370|P1|Participant Flow|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342902|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342903|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342955|NCT00772954|B3|Baseline|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
346162|NCT00766415|E1|Reported Event|AZD1981|AZD1981 1000 mg, twice daily
342904|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342905|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342906|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342907|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342908|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342909|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342910|NCT00773370|E2|Reported Event|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
342911|NCT00773370|E1|Reported Event|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
342912|NCT00773253|B3|Baseline|Total|Total of all reporting groups
342913|NCT00773253|B2|Baseline|Multi-channel EMG-guided Botox Injection Then Single Channel|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
342914|NCT00773253|B1|Baseline|Standard EMG Guided Injections Then Multi-channel|All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
342915|NCT00773253|P2|Participant Flow|Multi-channel EMG-guided Botox Injection Then Standard EMG Inj|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
342916|NCT00773253|P1|Participant Flow|Standard EMG Guided Injections Then Multi-channel Injections|All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
342917|NCT00773253|O2|Outcome|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
342918|NCT00773253|O1|Outcome|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
342919|NCT00773253|E2|Reported Event|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
342920|NCT00773253|E1|Reported Event|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
342956|NCT00772954|B2|Baseline|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342957|NCT00772954|B1|Baseline|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
342921|NCT00773136|B1|Baseline|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
342922|NCT00773136|P1|Participant Flow|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
342923|NCT00773136|O2|Outcome|Control Group|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
342924|NCT00773136|O1|Outcome|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
342925|NCT00773136|E1|Reported Event|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
342926|NCT00773097|B1|Baseline|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342927|NCT00773097|P1|Participant Flow|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342928|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342929|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342930|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342931|NCT00773097|E1|Reported Event|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
342932|NCT00772967|B1|Baseline|All Participants|All randomized participants
342933|NCT00772967|P6|Participant Flow|Ultracet, Naproxen, Placebo|Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.
342934|NCT00772967|P5|Participant Flow|Naproxen, Placebo, Ultracet|Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.
342935|NCT00772967|P4|Participant Flow|Placebo, Ultracet, Naproxen|Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.
342936|NCT00772967|P3|Participant Flow|Ultracet, Placebo, Naproxen|Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.
342937|NCT00772967|P2|Participant Flow|Naproxen, Ultracet, Placebo|Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.
342938|NCT00772967|P1|Participant Flow|Placebo, Naproxen, Ultracet|Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.
342939|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
342940|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
342941|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
342942|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
342943|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
342944|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
342945|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
342946|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
342947|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
342948|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
342949|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
342950|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
342951|NCT00772967|E3|Reported Event|Ultracet|Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.
342952|NCT00772967|E2|Reported Event|Naproxen|Participants treated with at least one dose of Naproxen
342953|NCT00772967|E1|Reported Event|Placebo|Participants treated with at least one dose of Placebo
342958|NCT00772954|P3|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342959|NCT00772954|P2|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342960|NCT00772954|P1|Participant Flow|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
342961|NCT00772954|O3|Outcome|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342962|NCT00772954|O2|Outcome|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342963|NCT00772954|O1|Outcome|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
342964|NCT00772954|E3|Reported Event|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342965|NCT00772954|E2|Reported Event|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
342966|NCT00772954|E1|Reported Event|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
342967|NCT00772941|B1|Baseline|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342968|NCT00772941|P1|Participant Flow|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342969|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342970|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342971|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342972|NCT00772941|O2|Outcome|Varenicline - Without Antipsychotics as a Concomitant Drug|Varenicline without Antipsychotics as a Concomitant Drug
342973|NCT00772941|O1|Outcome|Varenicline - With Antipsychotics as a Concomitant Drug|Varenicline with Antipsychotics as a Concomitant Drug
342974|NCT00772941|O2|Outcome|Administration Not Prolonged After 12 Weeks|Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
342975|NCT00772941|O1|Outcome|Administration Prolonged After 12 Weeks|Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
342976|NCT00772941|O3|Outcome|>=41 Cigarettes Per Day|Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
342977|NCT00772941|O2|Outcome|>=21 and <=40 Cigarettes Per Day|Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
342978|NCT00772941|O1|Outcome|<=20 Cigarettes Per Day|Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
342979|NCT00772941|O6|Outcome|>= 80 kg at Baseline|Participants whose weights at baseline were more than or equal to 80 kg.
342980|NCT00772941|O5|Outcome|>=70 kg and <80 kg at Baseline|Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
342981|NCT00772941|O4|Outcome|>=60 kg and <70 kg at Baseline|Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
342982|NCT00772941|O3|Outcome|>=50 kg and <60 kg at Baseline|Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
342983|NCT00772941|O2|Outcome|>=40 kg and <50 kg at Baseline|Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
342984|NCT00772941|O1|Outcome|<40 kg at Baseline|Participants whose weights at baseline were less than 40 kg.
342985|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Therapies|Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
342986|NCT00772941|O1|Outcome|Varenicline - With Concomitant Therapies|Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
342987|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Drugs|Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
342988|NCT00772941|O1|Outcome|Varenicline - With Concomitant Drugs|Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
342989|NCT00772941|O2|Outcome|Varenicline - Without Chronic Obstructive Pulmonary Disease|Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
342990|NCT00772941|O1|Outcome|Varenicline - With Chronic Obstructive Pulmonary Disease|Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
342991|NCT00772941|O2|Outcome|>=65 Years|Participants with >=65 years taking Varenicline according to Japanese Package Insert.
342992|NCT00772941|O1|Outcome|<65 Years|Participants with <65 years taking Varenicline according to Japanese Package Insert.
342993|NCT00772941|O2|Outcome|Female|Female participants taking Varenicline according to Japanese Package Insert.
342994|NCT00772941|O1|Outcome|Male|Male participants taking Varenicline according to Japanese Package Insert.
342995|NCT00772941|E1|Reported Event|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
342996|NCT00772928|B3|Baseline|Total|Total of all reporting groups
342997|NCT00772928|B2|Baseline|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
342998|NCT00772928|B1|Baseline|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
342999|NCT00772928|P2|Participant Flow|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
343000|NCT00772928|P1|Participant Flow|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
343001|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
343003|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
343004|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
343005|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
343006|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
343007|NCT00772928|E2|Reported Event|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
343008|NCT00772928|E1|Reported Event|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
343009|NCT00772915|B1|Baseline|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
343010|NCT00772915|P1|Participant Flow|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
343011|NCT00772915|O1|Outcome|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
343012|NCT00772915|E1|Reported Event|Lenalidomide With On-Demand Dexamethasone|Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
343013|NCT00772889|B4|Baseline|Total|Total of all reporting groups
343014|NCT00772889|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343015|NCT00772889|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343016|NCT00772889|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343017|NCT00772889|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343018|NCT00772889|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343019|NCT00772889|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343020|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343021|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343022|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343023|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343024|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343025|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343026|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343027|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343028|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343029|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343030|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343031|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343032|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343033|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343034|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343035|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343036|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343037|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343038|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343039|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343040|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343041|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343042|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343043|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343044|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343045|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343046|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343047|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343049|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343050|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343051|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343052|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343053|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343054|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343055|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343056|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343057|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343058|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343059|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343060|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343061|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343062|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343063|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343064|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343065|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343066|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343067|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343068|NCT00772889|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
343069|NCT00772889|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
343070|NCT00772889|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
343071|NCT00772772|B1|Baseline|Vitamin D3|
343072|NCT00772772|P1|Participant Flow|Vitamin D3|Vitamin D3 30,000 units PO weekly for 8 weeks
343073|NCT00772772|O1|Outcome|CKD Patients|
343074|NCT00772772|O1|Outcome|Patients With Chronic Kidney Disease (CKD)|CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
343075|NCT00772772|E1|Reported Event|Vitamin D3|
343076|NCT00772707|B1|Baseline|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
343077|NCT00772707|P1|Participant Flow|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
343078|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
343079|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
343080|NCT00772707|E1|Reported Event|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
343081|NCT00772668|B1|Baseline|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
343082|NCT00772668|P1|Participant Flow|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
343083|NCT00772668|O1|Outcome|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
343084|NCT00772668|E1|Reported Event|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
343085|NCT00772629|B3|Baseline|Total|Total of all reporting groups
343086|NCT00772629|B2|Baseline|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
343087|NCT00772629|B1|Baseline|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
343088|NCT00772629|P2|Participant Flow|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
343089|NCT00772629|P1|Participant Flow|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
343090|NCT00772629|O2|Outcome|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
343092|NCT00772629|E2|Reported Event|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
343093|NCT00772629|E1|Reported Event|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
343094|NCT00772603|B4|Baseline|Total|Total of all reporting groups
343095|NCT00772603|B3|Baseline|Placebo|Placebo given once daily.
343096|NCT00772603|B2|Baseline|1200mg/Day SPN-804|1200mg SPN-804O given once daily
343097|NCT00772603|B1|Baseline|2400mg/Day SPN-804|2400mg SPN-804O once daily
343098|NCT00772603|P3|Participant Flow|Placebo|Placebo once daily
343099|NCT00772603|P2|Participant Flow|1200mg/Day SPN-804|1200mg SPN-804O once daily
343100|NCT00772603|P1|Participant Flow|2400mg/Day SPN-804|2400mg of SPN-804O once daily
343101|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
343102|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
343103|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
343104|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
343105|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
343106|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
343107|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
343108|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
343109|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
343110|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
343111|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
343112|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
343113|NCT00772603|O3|Outcome|Placebo|Placebo once daily.
343114|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804 once daily
343115|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804 once daily
343116|NCT00772603|E3|Reported Event|Placebo|placebo QD, given as four placebo tablets
343117|NCT00772603|E2|Reported Event|1200mg/Day SPN-804|1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.
343118|NCT00772603|E1|Reported Event|2400mg/Day SPN-804|2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets
343119|NCT00772590|B5|Baseline|Total|Total of all reporting groups
343120|NCT00772590|B4|Baseline|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
343121|NCT00772590|B3|Baseline|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
343122|NCT00772590|B2|Baseline|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
343123|NCT00772590|B1|Baseline|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
343124|NCT00772590|P4|Participant Flow|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
343125|NCT00772590|P3|Participant Flow|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
343126|NCT00772590|P2|Participant Flow|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
343127|NCT00772590|P1|Participant Flow|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
343128|NCT00772590|O4|Outcome|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
343129|NCT00772590|O3|Outcome|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
343130|NCT00772590|O2|Outcome|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
343131|NCT00772590|O1|Outcome|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
343132|NCT00772590|E4|Reported Event|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
343133|NCT00772590|E3|Reported Event|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
343134|NCT00772590|E2|Reported Event|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
343135|NCT00772590|E1|Reported Event|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
343136|NCT00772577|B3|Baseline|Total|Total of all reporting groups
343137|NCT00772577|B2|Baseline|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343138|NCT00772577|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343139|NCT00772577|P2|Participant Flow|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343140|NCT00772577|P1|Participant Flow|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343141|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343142|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343143|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343144|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343145|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343146|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343147|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343148|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343149|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343150|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343151|NCT00772577|E2|Reported Event|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
343152|NCT00772577|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
343153|NCT00772538|B3|Baseline|Total|Total of all reporting groups
343154|NCT00772538|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343155|NCT00772538|B1|Baseline|Placebo|Patients treated with matching placebo
343156|NCT00772538|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343169|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343170|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343171|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343172|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343173|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343174|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343175|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343176|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343177|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343178|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343179|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343180|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343181|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343182|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343183|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343184|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343185|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343186|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343187|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343188|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343189|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343190|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343191|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343192|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343193|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343194|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343195|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343196|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343197|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343198|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343199|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343200|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343201|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343202|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343203|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343204|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343205|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343206|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343207|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343208|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343209|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343210|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343211|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343212|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343213|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343214|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343215|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343216|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343217|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343218|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343219|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343220|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343221|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343222|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
343223|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
343224|NCT00772538|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 Î¼g qd
343225|NCT00772538|E1|Reported Event|Placebo|Patients treated with matching placebo
343226|NCT00772447|B3|Baseline|Total|Total of all reporting groups
343227|NCT00772447|B2|Baseline|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343228|NCT00772447|B1|Baseline|Daptomycin|daptomycin 4mg/kg iv every 24hours
343229|NCT00772447|P2|Participant Flow|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343230|NCT00772447|P1|Participant Flow|Daptomycin|daptomycin 4mg/kg iv every 24hours
343231|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343232|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343233|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343234|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343235|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343236|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343237|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343238|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343239|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343240|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343241|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343242|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343243|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343244|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343245|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343246|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343247|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343248|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343249|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343250|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343251|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343252|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343253|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343254|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
343255|NCT00772447|E2|Reported Event|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
343256|NCT00772447|E1|Reported Event|Daptomycin|daptomycin 4mg/kg iv every 24hours
343257|NCT00772382|B1|Baseline|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
343258|NCT00772382|P1|Participant Flow|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
343259|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
343260|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
343261|NCT00772382|E1|Reported Event|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
343262|NCT00772369|B1|Baseline|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
343263|NCT00772369|P1|Participant Flow|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
343264|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
343265|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
343266|NCT00772369|E1|Reported Event|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
343267|NCT00772304|B1|Baseline|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
343268|NCT00772304|P1|Participant Flow|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
343269|NCT00772304|O1|Outcome|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
343270|NCT00772304|E1|Reported Event|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
343271|NCT00772148|B3|Baseline|Total|Total of all reporting groups
343272|NCT00772148|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343273|NCT00772148|B1|Baseline|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343274|NCT00772148|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343275|NCT00772148|P1|Participant Flow|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343276|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343277|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343278|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343279|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343280|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343281|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343282|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343283|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343284|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343285|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343286|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343287|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343288|NCT00772148|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
343289|NCT00772148|E1|Reported Event|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
343290|NCT00772109|B5|Baseline|Total|Total of all reporting groups
343291|NCT00772109|B4|Baseline|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343292|NCT00772109|B3|Baseline|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343293|NCT00772109|B2|Baseline|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343294|NCT00772109|B1|Baseline|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343295|NCT00772109|P4|Participant Flow|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343296|NCT00772109|P3|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343345|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343297|NCT00772109|P2|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343298|NCT00772109|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343299|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343300|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343301|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343302|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343303|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343304|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343305|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343306|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343307|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343308|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343309|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343310|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343311|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343312|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343313|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343314|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343315|NCT00772109|E4|Reported Event|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
343316|NCT00772109|E3|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
343317|NCT00772109|E2|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
343318|NCT00772109|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
343319|NCT00772070|B3|Baseline|Total|Total of all reporting groups
343320|NCT00772070|B2|Baseline|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343321|NCT00772070|B1|Baseline|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343322|NCT00772070|P2|Participant Flow|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343323|NCT00772070|P1|Participant Flow|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343324|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343325|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343326|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343327|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343328|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343329|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343330|NCT00772070|E2|Reported Event|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
343331|NCT00772070|E1|Reported Event|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
343332|NCT00772031|B3|Baseline|Total|Total of all reporting groups
343333|NCT00772031|B2|Baseline|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343334|NCT00772031|B1|Baseline|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343335|NCT00772031|P2|Participant Flow|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343336|NCT00772031|P1|Participant Flow|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343337|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343338|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343339|NCT00772031|O4|Outcome|Topiramate Plus Placebo, Prior, Stable Topiramate|Participants with prior stable topiramate use received a placebo and topiramate.
343340|NCT00772031|O3|Outcome|Topiramate Plus Propranolol, Prior, Stable Topiramate|Participants with prior stable topiramate use received propranolol and topiramate.
343341|NCT00772031|O2|Outcome|Topiramate Plus Placebo, no Prior, Stable Topiramate|Participants without prior stable topiramate use received a placebo and topiramate.
343342|NCT00772031|O1|Outcome|Topiramate Plus Propranolol, no Prior, Stable Topiramate|Participants without prior stable topiramate use received propranolol and topiramate.
343343|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343344|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343346|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343347|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343348|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343349|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
343350|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343351|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
343352|NCT00772031|O1|Outcome|Topiramate Plus Proporanolol|Participants will receive propranolol and topiramate.
343353|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
343354|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343355|NCT00772031|E2|Reported Event|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
343356|NCT00772031|E1|Reported Event|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
343357|NCT00772005|B5|Baseline|Total|Total of all reporting groups
343358|NCT00772005|B4|Baseline|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343359|NCT00772005|B3|Baseline|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343360|NCT00772005|B2|Baseline|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343361|NCT00772005|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343362|NCT00772005|P4|Participant Flow|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343363|NCT00772005|P3|Participant Flow|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343364|NCT00772005|P2|Participant Flow|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343365|NCT00772005|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343366|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344090|NCT00771875|B3|Baseline|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
343367|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343368|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343369|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343370|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343371|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343372|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343373|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343374|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343375|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343376|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343377|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344091|NCT00771875|B2|Baseline|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344356|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344357|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
343378|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343379|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343380|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343381|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343382|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343383|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343384|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343385|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343386|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343387|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343388|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344108|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344109|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
343389|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343390|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343391|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343392|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343393|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343394|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343395|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343396|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343397|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343398|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343399|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344141|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344142|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344143|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
344788|NCT00770861|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
343400|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343401|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343402|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343403|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343404|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343405|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343406|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343407|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343408|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343409|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343410|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344144|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344145|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344146|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345256|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
343411|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343412|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343413|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343414|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343415|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343416|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343417|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343418|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343419|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343420|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343421|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344147|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344148|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344149|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345257|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
343422|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343423|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343424|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343425|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343426|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343427|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343428|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343429|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343430|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343431|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343432|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344150|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344151|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344152|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345258|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
343433|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343434|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343435|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343436|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343437|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343438|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343439|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343440|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343441|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343442|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343443|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344153|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344154|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344155|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345259|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
343444|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343445|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343446|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343447|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343448|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343449|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343450|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343451|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343452|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343453|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343454|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344156|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344157|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344158|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345260|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
343455|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343456|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343457|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343458|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343459|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343460|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343461|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343462|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343463|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343464|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343465|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344159|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344160|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344161|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345261|NCT00769561|E2|Reported Event|Occlusal Splint|Dental treatment with occlusal splint
343466|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343467|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343468|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343469|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343470|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343471|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343472|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343473|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343474|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343475|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343476|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344162|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344163|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344164|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345262|NCT00769561|E1|Reported Event|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
343477|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343478|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343479|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343480|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343481|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343482|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343483|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343484|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343485|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343486|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343487|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344165|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344166|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344167|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345263|NCT00769314|B3|Baseline|Total|Total of all reporting groups
343488|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343489|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343490|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343491|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343492|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343493|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343494|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343495|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343496|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343497|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343498|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344168|NCT00771810|E3|Reported Event|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344169|NCT00771810|E2|Reported Event|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344170|NCT00771810|E1|Reported Event|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
344171|NCT00771758|B4|Baseline|Total|Total of all reporting groups
343499|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343500|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343501|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343502|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343503|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343504|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343505|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343506|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343507|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343508|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343509|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344172|NCT00771758|B3|Baseline|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344173|NCT00771758|B2|Baseline|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344174|NCT00771758|B1|Baseline|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344175|NCT00771758|P3|Participant Flow|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
343510|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343511|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343512|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343513|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343514|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343515|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343516|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343517|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343518|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343519|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343520|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344176|NCT00771758|P2|Participant Flow|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344177|NCT00771758|P1|Participant Flow|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344178|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344179|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343521|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343522|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343523|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343524|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343525|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343526|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343527|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343528|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343529|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343530|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343531|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344180|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344181|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344182|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344183|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343532|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343533|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343534|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343535|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343536|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343537|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343538|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343539|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343540|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343541|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343542|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344184|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344185|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344186|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344187|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
346342|NCT00765817|B3|Baseline|Total|Total of all reporting groups
343543|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343544|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343545|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343546|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343547|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343548|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343549|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343550|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343551|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343552|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343553|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344188|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344189|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344190|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344191|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343554|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343555|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343556|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343557|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343558|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343559|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343560|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343561|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343562|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343563|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343564|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344192|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344193|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344194|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344195|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343565|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343566|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343567|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343568|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343569|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343570|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343571|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343572|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343573|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343574|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343575|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344196|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344197|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344198|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344199|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348756|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
343576|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343577|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343578|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343579|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343580|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343581|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343582|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343583|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343584|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343585|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343586|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344200|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344201|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344202|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344203|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343587|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343588|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343589|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343590|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343591|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343592|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343593|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343594|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343595|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343596|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343597|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344204|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344205|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344206|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344207|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343598|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343599|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343600|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343601|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343602|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343603|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343604|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343605|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343606|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343607|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343608|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344208|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344209|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344210|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344211|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348757|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
343609|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343610|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343611|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343612|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343613|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343614|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343615|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343616|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343617|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343618|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343619|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344212|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344213|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344214|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344215|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343620|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343621|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343622|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343623|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343624|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343625|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343626|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343627|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343628|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343629|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343630|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344216|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344217|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344218|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344219|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343631|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343632|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343633|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343634|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343635|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343636|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343637|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343638|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343639|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343640|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343641|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344220|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344221|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344222|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344223|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348758|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
343642|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343643|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343644|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343645|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343646|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343647|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343648|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343649|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343650|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343651|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343652|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344224|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344225|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344226|NCT00771758|O5|Outcome|Baseline Total|Placebo
344227|NCT00771758|O4|Outcome|Poor - End of Study|Placebo
344228|NCT00771758|O3|Outcome|Fair - End of Study|Placebo
344229|NCT00771758|O2|Outcome|Good - End of Study|Placebo
343653|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343654|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343655|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343656|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343657|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343658|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343659|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343660|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343661|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343662|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343663|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344230|NCT00771758|O1|Outcome|Excellent - End of Study|Placebo
344231|NCT00771758|O6|Outcome|Baseline Total|Oxycodone IR
344232|NCT00771758|O5|Outcome|Missing - End of Study|Oxycodone IR
344233|NCT00771758|O4|Outcome|Poor - End of Study|Oxycodone IR
344234|NCT00771758|O3|Outcome|Fair - End of Study|Oxycodone IR
344235|NCT00771758|O2|Outcome|Good - End of Study|Oxycodone IR
344236|NCT00771758|O1|Outcome|Excellent - End of Study|Oxycodone IR
343664|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343665|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343666|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343667|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343668|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343669|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343670|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343671|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343672|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343673|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343674|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344237|NCT00771758|O6|Outcome|Baseline Total|Tapentadol IR
344238|NCT00771758|O5|Outcome|Missing - End of Study|Tapentadol IR
344239|NCT00771758|O4|Outcome|Poor - End of Study|Tapentadol IR
344240|NCT00771758|O3|Outcome|Fair - End of Study|Tapentadol IR
344241|NCT00771758|O2|Outcome|Good - End of Study|Tapentadol IR
344242|NCT00771758|O1|Outcome|Excellent - End of Study|Tapentadol IR
344243|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
343675|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343676|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343677|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343678|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343679|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343680|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343681|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343682|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343683|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343684|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343685|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344244|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344245|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344246|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344247|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343686|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343687|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343688|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343689|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343690|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343691|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343692|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343693|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343694|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343695|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343696|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344248|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344249|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344250|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344251|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343697|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343698|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343699|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343700|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343701|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343702|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343703|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343704|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343705|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343706|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343707|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344252|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344253|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344254|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344255|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348759|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
343708|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343709|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343710|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343711|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343712|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343713|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343714|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343715|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343716|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343717|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343718|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344256|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344257|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344258|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344259|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343719|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343720|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343721|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343722|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343723|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343724|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343725|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343726|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343727|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343728|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343729|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344260|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344261|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344262|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344263|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343730|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343731|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343732|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343733|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343734|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343735|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343736|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343737|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343738|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343739|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343740|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344264|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344265|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344266|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344267|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348760|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
343741|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343742|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343743|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343744|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343745|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343746|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343747|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343748|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343749|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343750|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343751|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344268|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344269|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344270|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344271|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343752|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343753|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343754|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343755|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343756|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343757|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343758|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343759|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343760|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343761|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343762|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344272|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344273|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344274|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344275|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343763|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343764|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343765|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343766|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343767|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343768|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343769|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343770|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343771|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343772|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343773|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344276|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344277|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344278|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344279|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348761|NCT00761306|E1|Reported Event|Vortioxetine 5 or 10 mg/Day|
343774|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343775|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343776|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343777|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343778|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343779|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343780|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343781|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343782|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343783|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343784|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344280|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344281|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344282|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344283|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343785|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343786|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343787|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343788|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343789|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343790|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343791|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343792|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343793|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343794|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343795|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344284|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344285|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344286|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344287|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343796|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343797|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343798|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343799|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343800|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343801|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343802|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343803|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343804|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343805|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343806|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344288|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344289|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344290|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344291|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
348762|NCT00761280|B3|Baseline|Total|Total of all reporting groups
343807|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343808|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343809|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343810|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343811|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343812|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343813|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343814|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343815|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343816|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343817|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344292|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344293|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344294|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344295|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343818|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343819|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343820|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343821|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343822|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343823|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343824|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343825|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343826|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343827|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343828|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344296|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344297|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344298|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344299|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343829|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343830|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343831|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343832|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343833|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343834|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343835|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343836|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343837|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343838|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343839|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344300|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344301|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344302|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344303|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
343840|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343841|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343842|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343843|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343844|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343845|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343846|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343847|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343848|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343849|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343850|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344304|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344305|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344306|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344307|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343851|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343852|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343853|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343854|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343855|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343856|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343857|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343858|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343859|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343860|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343861|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344308|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344309|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344310|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344311|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343862|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343863|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343864|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343865|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343866|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343867|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343868|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343869|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343870|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343871|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343872|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344312|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344313|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344314|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344315|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
343873|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343874|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343875|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343876|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343877|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343878|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343879|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343880|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343881|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343882|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343883|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344316|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344317|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344318|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344319|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
343884|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343885|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343886|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343887|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343888|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343889|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343890|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343891|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343892|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343893|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343894|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344320|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
344321|NCT00771758|E3|Reported Event|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
344322|NCT00771758|E2|Reported Event|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
344323|NCT00771758|E1|Reported Event|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
343895|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343896|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343897|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343898|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343899|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343900|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343901|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343902|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343903|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343904|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343905|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344324|NCT00771745|B3|Baseline|Total|Total of all reporting groups
344325|NCT00771745|B2|Baseline|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
343906|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343907|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343908|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343909|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343910|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343911|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343912|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343913|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343914|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343915|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343916|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344326|NCT00771745|B1|Baseline|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
344358|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
343917|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343918|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343919|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343920|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343921|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343922|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343923|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343924|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343925|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343926|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343927|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344327|NCT00771745|P2|Participant Flow|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
344359|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
343928|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343929|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343930|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343931|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343932|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343933|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343934|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343935|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343936|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343937|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343938|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344328|NCT00771745|P1|Participant Flow|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
344360|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
343939|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343940|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343941|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343942|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343943|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343944|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343945|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343946|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343947|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343948|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343949|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344329|NCT00771745|O2|Outcome|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
344361|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
343950|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343951|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343952|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343953|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343954|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343955|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343956|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343957|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343958|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343959|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343960|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344330|NCT00771745|O1|Outcome|Preloading Induction With Thymoglobulin x 4 Doses|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
344362|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
343961|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343962|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343963|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343964|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343965|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343966|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343967|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343968|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343969|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343970|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343971|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344331|NCT00771745|E2|Reported Event|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
344363|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
343972|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343973|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343974|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343975|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343976|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343977|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343978|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343979|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343980|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343981|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343982|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344332|NCT00771745|E1|Reported Event|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
344333|NCT00771667|B5|Baseline|Total|Total of all reporting groups
345527|NCT00768599|P1|Participant Flow|Reference Drug|Econazole Nitrate Cream 1%
343983|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343984|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343985|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343986|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343987|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343988|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343989|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343990|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343991|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343992|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343993|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344334|NCT00771667|B4|Baseline|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344335|NCT00771667|B3|Baseline|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344336|NCT00771667|B2|Baseline|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344337|NCT00771667|B1|Baseline|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
343994|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343995|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343996|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343997|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343998|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
343999|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344000|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344001|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344002|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344003|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344004|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344338|NCT00771667|P10|Participant Flow|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
344339|NCT00771667|P9|Participant Flow|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
345528|NCT00768599|O3|Outcome|Control|Vehicle Foam
344005|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344006|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344007|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344008|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344009|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344010|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344011|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344012|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344013|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344014|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344015|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344340|NCT00771667|P8|Participant Flow|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
344341|NCT00771667|P7|Participant Flow|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
345529|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
344016|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344017|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344018|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344019|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344020|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344021|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344022|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344023|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344024|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344025|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344026|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344342|NCT00771667|P6|Participant Flow|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
344343|NCT00771667|P5|Participant Flow|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
345530|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
344027|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344028|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344029|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344030|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344031|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344032|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344033|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344034|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344035|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344036|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344037|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344344|NCT00771667|P4|Participant Flow|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344345|NCT00771667|P3|Participant Flow|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344346|NCT00771667|P2|Participant Flow|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344347|NCT00771667|P1|Participant Flow|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
344038|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344039|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344040|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344041|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344042|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344043|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344044|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344045|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344046|NCT00772005|E4|Reported Event|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344047|NCT00772005|E3|Reported Event|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344048|NCT00772005|E2|Reported Event|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344348|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
344349|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
344350|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
344351|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
344352|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344049|NCT00772005|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
344050|NCT00771953|B3|Baseline|Total|Total of all reporting groups
344051|NCT00771953|B2|Baseline|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344052|NCT00771953|B1|Baseline|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344053|NCT00771953|P2|Participant Flow|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344054|NCT00771953|P1|Participant Flow|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344055|NCT00771953|O4|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed 500mg/m2 q21 days
344056|NCT00771953|O3|Outcome|Apricoxib Plus Pemetrexed|Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
344057|NCT00771953|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel 75mg/m2 q21 days
344058|NCT00771953|O1|Outcome|Apricoxib Plus Docetaxel|Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
344059|NCT00771953|E2|Reported Event|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344060|NCT00771953|E1|Reported Event|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
344061|NCT00771927|B3|Baseline|Total|Total of all reporting groups
344062|NCT00771927|B2|Baseline|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
344063|NCT00771927|B1|Baseline|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
344064|NCT00771927|P2|Participant Flow|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
344065|NCT00771927|P1|Participant Flow|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
344066|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
344067|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
344068|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
344069|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
344070|NCT00771927|E2|Reported Event|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
344071|NCT00771927|E1|Reported Event|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
344072|NCT00771914|B5|Baseline|Total|Total of all reporting groups
344073|NCT00771914|B4|Baseline|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
344074|NCT00771914|B3|Baseline|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
344075|NCT00771914|B2|Baseline|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
344076|NCT00771914|B1|Baseline|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
344077|NCT00771914|P4|Participant Flow|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
344078|NCT00771914|P3|Participant Flow|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin
344079|NCT00771914|P2|Participant Flow|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin
344080|NCT00771914|P1|Participant Flow|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
344081|NCT00771914|O4|Outcome|Both Aspirin and Lovaza|All participants received Aspirin and Lovaza intervention regardless of sequence.
344082|NCT00771914|O3|Outcome|Lovaza|All participants received Lovaza intervention regardless of sequence.
344083|NCT00771914|O2|Outcome|Aspirin|All participants received Aspirin intervention regardless of sequence.
344084|NCT00771914|O1|Outcome|Placebo|All participants received Placebo intervention regardless of sequence.
344085|NCT00771914|E4|Reported Event|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
344086|NCT00771914|E3|Reported Event|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
344087|NCT00771914|E2|Reported Event|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
344088|NCT00771914|E1|Reported Event|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
344089|NCT00771875|B4|Baseline|Total|Total of all reporting groups
344353|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344092|NCT00771875|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344093|NCT00771875|P3|Participant Flow|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344094|NCT00771875|P2|Participant Flow|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344095|NCT00771875|P1|Participant Flow|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344096|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344097|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344098|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344099|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344100|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344101|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344102|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344103|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344104|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344105|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344106|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344107|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344354|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344355|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
344110|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344111|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344112|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344113|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344114|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344115|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344116|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344117|NCT00771875|E3|Reported Event|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344118|NCT00771875|E2|Reported Event|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
344119|NCT00771875|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
344120|NCT00771849|B3|Baseline|Total|Total of all reporting groups
344121|NCT00771849|B2|Baseline|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
344122|NCT00771849|B1|Baseline|Menactra® Vaccine Group|Participants received Menactra® Vaccine
344123|NCT00771849|P2|Participant Flow|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
344124|NCT00771849|P1|Participant Flow|Menactra® Vaccine Group|Participants received Menactra® Vaccine
344125|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
344126|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
344127|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
344128|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
344129|NCT00771849|E2|Reported Event|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
344130|NCT00771849|E1|Reported Event|Menactra® Vaccine Group|Participants received Menactra® Vaccine
344131|NCT00771810|B4|Baseline|Total|Total of all reporting groups
344132|NCT00771810|B3|Baseline|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344133|NCT00771810|B2|Baseline|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344134|NCT00771810|B1|Baseline|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
344135|NCT00771810|P3|Participant Flow|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344136|NCT00771810|P2|Participant Flow|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344137|NCT00771810|P1|Participant Flow|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
344138|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
344139|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
344140|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
345531|NCT00768599|O3|Outcome|Control|Vehicle Foam
344364|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344365|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344366|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344367|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
344368|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344369|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344370|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344371|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
344372|NCT00771667|E10|Reported Event|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
344373|NCT00771667|E9|Reported Event|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
344374|NCT00771667|E8|Reported Event|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
344375|NCT00771667|E7|Reported Event|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
344376|NCT00771667|E6|Reported Event|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
344377|NCT00771667|E5|Reported Event|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
344378|NCT00771667|E4|Reported Event|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
344379|NCT00771667|E3|Reported Event|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
344380|NCT00771667|E2|Reported Event|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
344381|NCT00771667|E1|Reported Event|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
344382|NCT00771615|B10|Baseline|Total|Total of all reporting groups
344383|NCT00771615|B9|Baseline|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344384|NCT00771615|B8|Baseline|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344385|NCT00771615|B7|Baseline|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344386|NCT00771615|B6|Baseline|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344387|NCT00771615|B5|Baseline|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344388|NCT00771615|B4|Baseline|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344389|NCT00771615|B3|Baseline|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344390|NCT00771615|B2|Baseline|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344391|NCT00771615|B1|Baseline|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344392|NCT00771615|P9|Participant Flow|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344690|NCT00771316|E2|Reported Event|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344393|NCT00771615|P8|Participant Flow|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344394|NCT00771615|P7|Participant Flow|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344395|NCT00771615|P6|Participant Flow|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344396|NCT00771615|P5|Participant Flow|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344397|NCT00771615|P4|Participant Flow|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344398|NCT00771615|P3|Participant Flow|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344399|NCT00771615|P2|Participant Flow|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344400|NCT00771615|P1|Participant Flow|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344401|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344402|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344403|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344404|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344405|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344406|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344407|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344408|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344409|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344410|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
345008|NCT00770432|B2|Baseline|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
344411|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344412|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344413|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344414|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344415|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344416|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344417|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344418|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344419|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344420|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344421|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344422|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344423|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344424|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344425|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344426|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344427|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344428|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344691|NCT00771316|E1|Reported Event|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344429|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344430|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344431|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344432|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344433|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344434|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344435|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344436|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344437|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344438|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344439|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344440|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344441|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344442|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344443|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344444|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344445|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344446|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344447|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344448|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344449|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344450|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344451|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344452|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344453|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344454|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344455|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344456|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344457|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344613|NCT00771537|B7|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
345532|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
344458|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344459|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344460|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344461|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344462|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344463|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344464|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344465|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344466|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344467|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344468|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344614|NCT00771537|B6|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344692|NCT00771277|B1|Baseline|Arm 1|Family experience of concerns and providing support to TBI patient
344469|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344470|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344471|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344472|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344473|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344474|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344475|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344476|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344477|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344478|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344479|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344615|NCT00771537|B5|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
345533|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
344480|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344481|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344482|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344483|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344484|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344485|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344486|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344487|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344488|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344489|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344490|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344491|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344492|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344493|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344494|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344495|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344496|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344497|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344498|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344499|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344500|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344501|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344502|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344616|NCT00771537|B4|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
345534|NCT00768599|O3|Outcome|Control|Vehicle Foam
344503|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344504|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344505|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344506|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344507|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344508|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344509|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344510|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344511|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344512|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344513|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344617|NCT00771537|B3|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
345535|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
344514|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344515|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344516|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344517|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344518|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344519|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344520|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344521|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344522|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344523|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344524|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344618|NCT00771537|B2|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
345536|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
344525|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344526|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344527|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344528|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344529|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344530|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344531|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344532|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344533|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344534|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344535|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344536|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344537|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344538|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344539|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344540|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344541|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344542|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344543|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344544|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344545|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344546|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344547|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344619|NCT00771537|B1|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
345537|NCT00768599|O3|Outcome|Control|Vehicle Foam
344548|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344549|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344550|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344551|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344552|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344553|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344554|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344555|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344556|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344557|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344558|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344620|NCT00771537|P16|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344559|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344560|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344561|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344562|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344563|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344564|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344565|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344566|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344567|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344568|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344569|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344621|NCT00771537|P15|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344570|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344571|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344572|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344573|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344574|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344575|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344576|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344577|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344578|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344579|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
344580|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344581|NCT00771615|E9|Reported Event|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344689|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344582|NCT00771615|E8|Reported Event|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344583|NCT00771615|E7|Reported Event|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344584|NCT00771615|E6|Reported Event|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344585|NCT00771615|E5|Reported Event|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344586|NCT00771615|E4|Reported Event|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344587|NCT00771615|E3|Reported Event|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344588|NCT00771615|E2|Reported Event|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344589|NCT00771615|E1|Reported Event|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
344590|NCT00771602|B4|Baseline|Total|Total of all reporting groups
344591|NCT00771602|B3|Baseline|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
344592|NCT00771602|B2|Baseline|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
344593|NCT00771602|B1|Baseline|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
344594|NCT00771602|P3|Participant Flow|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
344595|NCT00771602|P2|Participant Flow|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
344596|NCT00771602|P1|Participant Flow|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
344597|NCT00771602|O3|Outcome|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
344598|NCT00771602|O2|Outcome|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
344599|NCT00771602|O1|Outcome|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
344600|NCT00771602|E3|Reported Event|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
344601|NCT00771602|E2|Reported Event|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
344602|NCT00771602|E1|Reported Event|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
344603|NCT00771537|B17|Baseline|Total|Total of all reporting groups
344604|NCT00771537|B16|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344605|NCT00771537|B15|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344606|NCT00771537|B14|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344607|NCT00771537|B13|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344608|NCT00771537|B12|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344609|NCT00771537|B11|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344610|NCT00771537|B10|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344611|NCT00771537|B9|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344612|NCT00771537|B8|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344622|NCT00771537|P14|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344623|NCT00771537|P13|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344624|NCT00771537|P12|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344625|NCT00771537|P11|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344626|NCT00771537|P10|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344627|NCT00771537|P9|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344628|NCT00771537|P8|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344629|NCT00771537|P7|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344630|NCT00771537|P6|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344631|NCT00771537|P5|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344632|NCT00771537|P4|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344633|NCT00771537|P3|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344634|NCT00771537|P2|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344635|NCT00771537|P1|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344636|NCT00771537|O4|Outcome|2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
344637|NCT00771537|O3|Outcome|2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
344638|NCT00771537|O2|Outcome|1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344639|NCT00771537|O1|Outcome|Control/Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344640|NCT00771537|O4|Outcome|2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344641|NCT00771537|O3|Outcome|2-Sided Trivial|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344642|NCT00771537|O2|Outcome|1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344643|NCT00771537|O1|Outcome|Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344644|NCT00771537|E16|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344645|NCT00771537|E15|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344646|NCT00771537|E14|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344647|NCT00771537|E13|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344648|NCT00771537|E12|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344731|NCT00771056|E1|Reported Event|Hydroxychloroquine|"Hydroxychloroquine 400 mg po daily for up to one year.~Hydroxychloroquine: 400mg by mouth daily x 1 year"
344649|NCT00771537|E11|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344650|NCT00771537|E10|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344651|NCT00771537|E9|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344652|NCT00771537|E8|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
344653|NCT00771537|E7|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
344654|NCT00771537|E6|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344655|NCT00771537|E5|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344656|NCT00771537|E4|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
344657|NCT00771537|E3|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
344658|NCT00771537|E2|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
344659|NCT00771537|E1|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
344660|NCT00771472|B1|Baseline|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344661|NCT00771472|P2|Participant Flow|Part II|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
344662|NCT00771472|P1|Participant Flow|Part I|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
344663|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344664|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344665|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344666|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344667|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344668|NCT00771472|O1|Outcome|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
344669|NCT00771472|E1|Reported Event|Vorinostat|Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle.
344670|NCT00771407|B3|Baseline|Total|Total of all reporting groups
344671|NCT00771407|B2|Baseline|Standard Ostomy Construction|Ostomy created in the standard fashion
344672|NCT00771407|B1|Baseline|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
344673|NCT00771407|P2|Participant Flow|Standard Ostomy Construction|Ostomy created in the standard fashion
344674|NCT00771407|P1|Participant Flow|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
344675|NCT00771407|O2|Outcome|Standard Ostomy Construction|Ostomy will be created in the standard fashion
344676|NCT00771407|O1|Outcome|Strattice Fascial Inlay|Strattice will be placed as a fascial inlay to support the ostomy site
344677|NCT00771407|E2|Reported Event|Standard Ostomy Construction|Ostomy created in the standard fashion
344678|NCT00771407|E1|Reported Event|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
344679|NCT00771316|B3|Baseline|Total|Total of all reporting groups
344680|NCT00771316|B2|Baseline|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344681|NCT00771316|B1|Baseline|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344682|NCT00771316|P2|Participant Flow|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344683|NCT00771316|P1|Participant Flow|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344684|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344685|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344686|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344687|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
344688|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
344693|NCT00771277|P1|Participant Flow|Arm 1|"Use of volunteer support teams to provide services~Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family"
344694|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
344695|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
344696|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
344697|NCT00771277|E1|Reported Event|TBI Caregivers|Family caregivers providing support to TBI patients.
344698|NCT00771264|B3|Baseline|Total|Total of all reporting groups
344699|NCT00771264|B2|Baseline|Sham / Placebo|
344700|NCT00771264|B1|Baseline|Urgent PC|
344701|NCT00771264|P2|Participant Flow|Sham / Placebo|
344702|NCT00771264|P1|Participant Flow|Urgent PC|
344703|NCT00771264|O2|Outcome|Sham / Placebo|
344704|NCT00771264|O1|Outcome|Urgent PC|
344705|NCT00771264|E2|Reported Event|Sham / Placebo|
344706|NCT00771264|E1|Reported Event|Urgent PC|
344707|NCT00771238|B3|Baseline|Total|Total of all reporting groups
344708|NCT00771238|B2|Baseline|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
344709|NCT00771238|B1|Baseline|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
344710|NCT00771238|P2|Participant Flow|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
344711|NCT00771238|P1|Participant Flow|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
344712|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
344713|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
344714|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
344715|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
344716|NCT00771238|E2|Reported Event|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
344717|NCT00771238|E1|Reported Event|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
344718|NCT00771173|B3|Baseline|Total|Total of all reporting groups
344719|NCT00771173|B2|Baseline|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
344720|NCT00771173|B1|Baseline|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
344721|NCT00771173|P2|Participant Flow|Active Agent Group|Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
344722|NCT00771173|P1|Participant Flow|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange."
344723|NCT00771173|O2|Outcome|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
344724|NCT00771173|O1|Outcome|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
344725|NCT00771173|E2|Reported Event|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
344726|NCT00771173|E1|Reported Event|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
344727|NCT00771056|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
344728|NCT00771056|P1|Participant Flow|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
344729|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
344730|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
344732|NCT00770991|B3|Baseline|Total|Total of all reporting groups
344733|NCT00770991|B2|Baseline|Two Berry Suppositories Bedtime Plus Placebo Powder|20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
344734|NCT00770991|B1|Baseline|Two Berry Suppositories Bedtime Plus Oral Berry Powder|20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
344735|NCT00770991|P2|Participant Flow|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
344736|NCT00770991|P1|Participant Flow|Placebo Powder Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
344737|NCT00770991|O3|Outcome|All Participants|
344738|NCT00770991|O2|Outcome|Lyophilized BRB Suppositories + BRB Slurry|
344739|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories + Placebo|Two, 730 mg BRB suppositories administered at bedtime.
344740|NCT00770991|O2|Outcome|Polyp|all participants used for this analysis
344741|NCT00770991|O1|Outcome|Normal Mucosa|all participants combined for this analysis. Sample of normal mucosa
344742|NCT00770991|O3|Outcome|All Participants|
344743|NCT00770991|O2|Outcome|Lypholized BRB Suppositiry Plus BRB Slurry|2 lyphilized black raspberry suppositories plus black raspberry slurry.
344744|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo|Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
344745|NCT00770991|E2|Reported Event|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
344746|NCT00770991|E1|Reported Event|Black Raspberry Placebo Slurry Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
344747|NCT00770965|B5|Baseline|Total|Total of all reporting groups
344748|NCT00770965|B4|Baseline|Placebo|Participants received placebo to AIN457A IV on day 1.
344749|NCT00770965|B3|Baseline|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
344750|NCT00770965|B2|Baseline|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
344751|NCT00770965|B1|Baseline|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
344752|NCT00770965|P4|Participant Flow|Placebo|Participants received placebo to AIN457A IV on day 1.
344753|NCT00770965|P3|Participant Flow|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
344754|NCT00770965|P2|Participant Flow|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
344755|NCT00770965|P1|Participant Flow|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
344756|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
344757|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
344758|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
344759|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
344760|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
344761|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
344762|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
344763|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
344764|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
344765|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
344766|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
344767|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
344768|NCT00770965|E4|Reported Event|Placebo|Placebo
344769|NCT00770965|E3|Reported Event|AIN457 3 mg/kg|AIN457 3 mg/kg
344770|NCT00770965|E2|Reported Event|AIN457 1 mg/kg|AIN457 1 mg/kg
344771|NCT00770965|E1|Reported Event|AIN457 0.3 mg/kg|AIN457 0.3 mg/kg
344772|NCT00770913|B4|Baseline|Total|Total of all reporting groups
344773|NCT00770913|B3|Baseline|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
344774|NCT00770913|B2|Baseline|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
344775|NCT00770913|B1|Baseline|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
344776|NCT00770913|P3|Participant Flow|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
344777|NCT00770913|P2|Participant Flow|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
344778|NCT00770913|P1|Participant Flow|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
344779|NCT00770913|O3|Outcome|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
344780|NCT00770913|O2|Outcome|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
344781|NCT00770913|O1|Outcome|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
344782|NCT00770913|E3|Reported Event|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
344783|NCT00770913|E2|Reported Event|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
344784|NCT00770913|E1|Reported Event|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
344785|NCT00770861|B3|Baseline|Total|Total of all reporting groups
344786|NCT00770861|B2|Baseline|Placebo|Matching placebo tablets, oral administration
344787|NCT00770861|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
344789|NCT00770861|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
344790|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
344791|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
344792|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
344793|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
344794|NCT00770861|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
344795|NCT00770861|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
344796|NCT00770809|B4|Baseline|Total|Total of all reporting groups
344797|NCT00770809|B3|Baseline|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
344798|NCT00770809|B2|Baseline|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
344799|NCT00770809|B1|Baseline|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
344800|NCT00770809|P3|Participant Flow|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
344801|NCT00770809|P2|Participant Flow|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
344802|NCT00770809|P1|Participant Flow|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
344803|NCT00770809|O3|Outcome|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
344804|NCT00770809|O2|Outcome|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
344805|NCT00770809|O1|Outcome|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
344806|NCT00770809|E3|Reported Event|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
344807|NCT00770809|E2|Reported Event|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
344808|NCT00770809|E1|Reported Event|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
344809|NCT00770770|B3|Baseline|Total|Total of all reporting groups
344810|NCT00770770|B2|Baseline|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
344811|NCT00770770|B1|Baseline|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
344812|NCT00770770|P2|Participant Flow|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
344813|NCT00770770|P1|Participant Flow|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
344814|NCT00770770|O2|Outcome|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
344815|NCT00770770|O1|Outcome|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
344816|NCT00770770|E2|Reported Event|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
344817|NCT00770770|E1|Reported Event|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
344818|NCT00770757|B1|Baseline|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344819|NCT00770757|P1|Participant Flow|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344820|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344821|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344970|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344822|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344823|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344824|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344825|NCT00770757|E1|Reported Event|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
344826|NCT00770692|B5|Baseline|Total|Total of all reporting groups
344827|NCT00770692|B4|Baseline|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344828|NCT00770692|B3|Baseline|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344829|NCT00770692|B2|Baseline|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344830|NCT00770692|B1|Baseline|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344831|NCT00770692|P4|Participant Flow|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344832|NCT00770692|P3|Participant Flow|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344833|NCT00770692|P2|Participant Flow|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344834|NCT00770692|P1|Participant Flow|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344835|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344836|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344837|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344838|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344839|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344840|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344841|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344842|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344843|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344844|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344869|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344845|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344846|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344847|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344848|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344849|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344850|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344851|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344852|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344853|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344854|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344855|NCT00770692|E4|Reported Event|Eszopiclone 2 mg Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344856|NCT00770692|E3|Reported Event|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344857|NCT00770692|E2|Reported Event|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
344858|NCT00770692|E1|Reported Event|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
344859|NCT00770653|B3|Baseline|Total|Total of all reporting groups
344860|NCT00770653|B2|Baseline|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344861|NCT00770653|B1|Baseline|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344862|NCT00770653|P2|Participant Flow|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344863|NCT00770653|P1|Participant Flow|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344864|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344865|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344866|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344867|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344868|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
345006|NCT00770484|E1|Reported Event|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
344870|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344871|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344872|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344873|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344874|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344875|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344876|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344877|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344878|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344879|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344880|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344881|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344882|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344883|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344884|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344885|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344886|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344887|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344888|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344889|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344890|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344891|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344892|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344893|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344894|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344968|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344895|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344896|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344897|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344898|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344899|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344900|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344901|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344902|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344903|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344904|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344905|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344906|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344907|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344908|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344909|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344910|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344911|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344912|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344913|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344914|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344915|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344916|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344917|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344918|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344919|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344969|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344920|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344921|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344922|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344923|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344924|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344925|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344926|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344927|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344928|NCT00770653|E2|Reported Event|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
344929|NCT00770653|E1|Reported Event|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
344930|NCT00770588|B3|Baseline|Total|Total of all reporting groups
344931|NCT00770588|B2|Baseline|Placebo|placebo 1 tablet daily
344932|NCT00770588|B1|Baseline|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344933|NCT00770588|P2|Participant Flow|Placebo|placebo 1 tablet daily
344934|NCT00770588|P1|Participant Flow|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344935|NCT00770588|O2|Outcome|Placebo|Placebo 1 tablet daily
344936|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344937|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
344938|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344939|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
344940|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344941|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
344942|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344943|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
344944|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344945|NCT00770588|E2|Reported Event|Placebo|placebo 1 tablet daily
344946|NCT00770588|E1|Reported Event|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
344947|NCT00770562|B3|Baseline|Total|Total of all reporting groups
344948|NCT00770562|B2|Baseline|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344949|NCT00770562|B1|Baseline|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
344950|NCT00770562|P2|Participant Flow|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344951|NCT00770562|P1|Participant Flow|Arm A: Dexamethasone|Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
345007|NCT00770432|B3|Baseline|Total|Total of all reporting groups
345538|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
344952|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344953|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
344954|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344955|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
344956|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344957|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
344958|NCT00770562|E3|Reported Event|Salvage Therapy|Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
344959|NCT00770562|E2|Reported Event|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
344960|NCT00770562|E1|Reported Event|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
344961|NCT00770510|B1|Baseline|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
344962|NCT00770510|P1|Participant Flow|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
344963|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344964|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344965|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344966|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344967|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344971|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344972|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344973|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344974|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344975|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344976|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344977|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344978|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344979|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344980|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344981|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344982|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344983|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344984|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344985|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344986|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344987|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344988|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344989|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344990|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344991|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344992|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344993|NCT00770510|E5|Reported Event|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344994|NCT00770510|E4|Reported Event|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344995|NCT00770510|E3|Reported Event|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344996|NCT00770510|E2|Reported Event|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344997|NCT00770510|E1|Reported Event|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
344998|NCT00770484|B3|Baseline|Total|Total of all reporting groups
344999|NCT00770484|B2|Baseline|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
345000|NCT00770484|B1|Baseline|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
345001|NCT00770484|P2|Participant Flow|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
345002|NCT00770484|P1|Participant Flow|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
345003|NCT00770484|O2|Outcome|Placebo|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
345004|NCT00770484|O1|Outcome|Propranolol|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
345005|NCT00770484|E2|Reported Event|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
345122|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345009|NCT00770432|B1|Baseline|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
345010|NCT00770432|P2|Participant Flow|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
345011|NCT00770432|P1|Participant Flow|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
345012|NCT00770432|O2|Outcome|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
345013|NCT00770432|O1|Outcome|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
345014|NCT00770432|E2|Reported Event|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
345015|NCT00770432|E1|Reported Event|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
345016|NCT00770367|B3|Baseline|Total|Total of all reporting groups
345017|NCT00770367|B2|Baseline|Placebo|The analysis period during which participant took the placebo.
345018|NCT00770367|B1|Baseline|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
345019|NCT00770367|P2|Participant Flow|Placebo|The analysis period during which participant took the placebo.
345020|NCT00770367|P1|Participant Flow|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
345021|NCT00770367|O2|Outcome|Placebo|The analysis period during which participant took the placebo.
345022|NCT00770367|O1|Outcome|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
345023|NCT00770367|E2|Reported Event|Placebo|The analysis period during which participant took the placebo.
345024|NCT00770367|E1|Reported Event|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
345025|NCT00770341|B4|Baseline|Total|Total of all reporting groups
345026|NCT00770341|B3|Baseline|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345027|NCT00770341|B2|Baseline|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345028|NCT00770341|B1|Baseline|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345029|NCT00770341|P3|Participant Flow|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345030|NCT00770341|P2|Participant Flow|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345031|NCT00770341|P1|Participant Flow|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345032|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345033|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345034|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345035|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345036|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345037|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345038|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345039|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345040|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345041|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345042|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345043|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345044|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345045|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345046|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345047|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
345048|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
345049|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
345050|NCT00770341|E4|Reported Event|DAPTOMYCIN (6 MG/KG)|
345051|NCT00770341|E3|Reported Event|VANCOMYCIN|
345052|NCT00770341|E2|Reported Event|DAPTOMYCIN (4 MG/KG)|
345053|NCT00770341|E1|Reported Event|NOT TREATED|
345054|NCT00770315|B5|Baseline|Total|Total of all reporting groups
345055|NCT00770315|B4|Baseline|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345056|NCT00770315|B3|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345057|NCT00770315|B2|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345058|NCT00770315|B1|Baseline|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345539|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
345059|NCT00770315|P4|Participant Flow|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345060|NCT00770315|P3|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345061|NCT00770315|P2|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345062|NCT00770315|P1|Participant Flow|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345063|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345064|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345065|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345066|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345067|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345068|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345069|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345070|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345071|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345072|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345073|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345074|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345075|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345076|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345077|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345078|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345079|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345080|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345081|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345082|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345083|NCT00770315|E4|Reported Event|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345084|NCT00770315|E3|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345085|NCT00770315|E2|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345086|NCT00770315|E1|Reported Event|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
345087|NCT00770289|B1|Baseline|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
345088|NCT00770289|P1|Participant Flow|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
345089|NCT00770289|O1|Outcome|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
345090|NCT00770289|O3|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
345091|NCT00770289|O2|Outcome|Hamilton Depression Scale (HAM-D7)|Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
345092|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D17)|Participants who were administered HAM-D17.
345093|NCT00770289|O1|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
345094|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D)|Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
345095|NCT00770289|E1|Reported Event|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
345096|NCT00770211|B3|Baseline|Total|Total of all reporting groups
345097|NCT00770211|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345098|NCT00770211|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345099|NCT00770211|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345100|NCT00770211|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345101|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345102|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345103|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345104|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345105|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345106|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345107|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345108|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345109|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345110|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345111|NCT00770211|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
345112|NCT00770211|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345113|NCT00770146|B3|Baseline|Total|Total of all reporting groups
345114|NCT00770146|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345115|NCT00770146|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345116|NCT00770146|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345117|NCT00770146|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345118|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345119|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345120|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345121|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345123|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345124|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345125|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345126|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345127|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345128|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345129|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345130|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345131|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345132|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345133|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345134|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345135|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345136|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345137|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345138|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345139|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345140|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345141|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345142|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345143|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345144|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345145|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345146|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345147|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345148|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345149|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345150|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345151|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345152|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345153|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345154|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345155|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345156|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345157|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345158|NCT00770146|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
345159|NCT00770146|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
345160|NCT00770029|B3|Baseline|Total|Total of all reporting groups
345161|NCT00770029|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345162|NCT00770029|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345163|NCT00770029|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345164|NCT00770029|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345165|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345166|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345250|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345167|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345168|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345169|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345170|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345171|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345172|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345173|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345174|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345175|NCT00770029|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
345176|NCT00770029|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
345177|NCT00769860|B3|Baseline|Total|Total of all reporting groups
345178|NCT00769860|B2|Baseline|Placebo|Matched placebo pills, 100 mg TID for 4 months
345179|NCT00769860|B1|Baseline|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345180|NCT00769860|P2|Participant Flow|Placebo|Matched placebo pills, 100 mg TID for 4 months
345181|NCT00769860|P1|Participant Flow|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345182|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345183|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345184|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345185|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345186|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345187|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345188|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345189|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345190|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345191|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345192|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345193|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345194|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345195|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345196|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345197|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345198|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345199|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345200|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345201|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345202|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
345203|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345204|NCT00769860|E2|Reported Event|Placebo|Matched placebo pills, 100 mg TID for 4 months
345205|NCT00769860|E1|Reported Event|Arimoclomol|Arimoclomol 100 mg TID for 4 months
345206|NCT00769704|B3|Baseline|Total|Total of all reporting groups
345207|NCT00769704|B2|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345208|NCT00769704|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345251|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345209|NCT00769704|P2|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345210|NCT00769704|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345211|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345212|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345213|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345214|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345215|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345216|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345217|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345218|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345219|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345220|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345221|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345222|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345252|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345253|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345254|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345255|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345223|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345224|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345225|NCT00769704|E2|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
345226|NCT00769704|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
345227|NCT00769652|B3|Baseline|Total|Total of all reporting groups
345228|NCT00769652|B2|Baseline|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345229|NCT00769652|B1|Baseline|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345230|NCT00769652|P2|Participant Flow|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345231|NCT00769652|P1|Participant Flow|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345232|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345233|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345234|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345235|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345236|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345237|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345238|NCT00769652|E2|Reported Event|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
345239|NCT00769652|E1|Reported Event|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
345240|NCT00769561|B3|Baseline|Total|Total of all reporting groups
345241|NCT00769561|B2|Baseline|Occlusal Splint|Dental treatment with occlusal splint
345242|NCT00769561|B1|Baseline|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345243|NCT00769561|P2|Participant Flow|Occlusal Splint|Dental treatment with occlusal splint
345244|NCT00769561|P1|Participant Flow|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345245|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345246|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345247|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345248|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
345249|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
345264|NCT00769314|B2|Baseline|Placebo Group|muco-adhesive buccal tablet with placebo/Intent-to-Treat population
345265|NCT00769314|B1|Baseline|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
345266|NCT00769314|P2|Participant Flow|Placebo Group|muco-adhesive buccal tablet with placebo
345267|NCT00769314|P1|Participant Flow|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345268|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345269|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345270|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345271|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345272|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345273|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345274|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345275|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345276|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345277|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345278|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345279|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345280|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345281|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345282|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345283|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345284|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345285|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345286|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345287|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345288|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
345289|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345290|NCT00769314|E2|Reported Event|Placebo Group|muco-adhesive buccal tablet with placebo
345291|NCT00769314|E1|Reported Event|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
345292|NCT00769184|B1|Baseline|Corticosteroid+LCD vs Corticosteroid+Placebo|"one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks~opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks"
345293|NCT00769184|P2|Participant Flow|Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)|"Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).~On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
345294|NCT00769184|P1|Participant Flow|Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)|"Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).~On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
345295|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo solution applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
345296|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution-only applied to one side of the body twice per day for 4 weeks.
345297|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
345298|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
345299|NCT00769184|E2|Reported Event|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
345300|NCT00769184|E1|Reported Event|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
345301|NCT00769132|B1|Baseline|Totals for Study|All participants in the study.
345302|NCT00769132|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
345303|NCT00769132|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
345304|NCT00769132|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
345305|NCT00769132|P1|Participant Flow|Sequence 1: D/C/A/B|"A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
345306|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
345307|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
345308|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
345309|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
345310|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
345311|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
345312|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
345313|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
345314|NCT00769132|E4|Reported Event|Placebo|Placebo once daily for 7 days
345315|NCT00769132|E3|Reported Event|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
345316|NCT00769132|E2|Reported Event|ER Niacin 2 g|ER niacin 2 g once daily for 7 days
345317|NCT00769132|E1|Reported Event|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg once daily for 7 days
345318|NCT00769119|B3|Baseline|Total|Total of all reporting groups
345319|NCT00769119|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
345320|NCT00769119|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345321|NCT00769119|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
345322|NCT00769119|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345323|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345324|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345325|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345326|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345327|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345328|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345329|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345330|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345331|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345332|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345333|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345334|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345335|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345336|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345337|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345338|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345339|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345340|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345341|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345342|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345343|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345344|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345345|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345346|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345347|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345348|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345349|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345350|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345351|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345352|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345353|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345354|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345355|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345356|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345357|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345358|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345359|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345360|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345361|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
345362|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345363|NCT00769119|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
345364|NCT00769119|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
345365|NCT00769067|B3|Baseline|Total|Total of all reporting groups
345366|NCT00769067|B2|Baseline|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345367|NCT00769067|B1|Baseline|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345368|NCT00769067|P2|Participant Flow|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345369|NCT00769067|P1|Participant Flow|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345370|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345371|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345372|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345373|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345374|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345375|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345376|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345377|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345378|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345379|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345380|NCT00769067|O1|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345381|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345382|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345383|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345384|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345385|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345386|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345387|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345388|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345389|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345390|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345391|NCT00769067|E2|Reported Event|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345392|NCT00769067|E1|Reported Event|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
345393|NCT00769015|B3|Baseline|Total|Total of all reporting groups
345394|NCT00769015|B2|Baseline|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345395|NCT00769015|B1|Baseline|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345396|NCT00769015|P2|Participant Flow|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345397|NCT00769015|P1|Participant Flow|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345398|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345399|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345400|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345401|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345402|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345403|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345404|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345405|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345406|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345407|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345408|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345409|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345410|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345411|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345412|NCT00769015|E2|Reported Event|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
345453|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345413|NCT00769015|E1|Reported Event|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
345414|NCT00768989|B3|Baseline|Total|Total of all reporting groups
345415|NCT00768989|B2|Baseline|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345416|NCT00768989|B1|Baseline|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
345417|NCT00768989|P2|Participant Flow|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345418|NCT00768989|P1|Participant Flow|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
345419|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345420|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345421|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345422|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345423|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345424|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345425|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345426|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345427|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345428|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345429|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345430|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345431|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345432|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345433|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345434|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345435|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345436|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345437|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345438|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345439|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345440|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345441|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345442|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345443|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345444|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345445|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345446|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
345447|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345448|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345449|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345450|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345451|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345452|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
345454|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345455|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345456|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345457|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345458|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
345459|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345460|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345461|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
345462|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
345463|NCT00768989|E2|Reported Event|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
345464|NCT00768989|E1|Reported Event|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily
345465|NCT00768898|B1|Baseline|Overall|All enrolled participants
345466|NCT00768898|P1|Participant Flow|Overall|All enrolled participants
345467|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
345468|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
345469|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
345470|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
345471|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
345472|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
345473|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
345474|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
345475|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
345476|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
345477|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
345478|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
345479|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
345480|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
345481|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green were instilled in each eye.
345482|NCT00768898|E3|Reported Event|10.0 Microliters Lissamine Green|10.0 microliters lissamine green
345483|NCT00768898|E2|Reported Event|5.0 Microliters Lissamine Green|5.0 microliters lissamine green
345484|NCT00768898|E1|Reported Event|2.5 Microliters Lissamine Green|2.5 microliters lissamine green
345485|NCT00768755|B5|Baseline|Total|Total of all reporting groups
345486|NCT00768755|B4|Baseline|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345487|NCT00768755|B3|Baseline|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345488|NCT00768755|B2|Baseline|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345489|NCT00768755|B1|Baseline|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
345490|NCT00768755|P4|Participant Flow|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345505|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345491|NCT00768755|P3|Participant Flow|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345492|NCT00768755|P2|Participant Flow|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345493|NCT00768755|P1|Participant Flow|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
345494|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345495|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345496|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345497|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345498|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345499|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345500|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345501|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345502|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345503|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345504|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345506|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345507|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345508|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345509|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345510|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345511|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345512|NCT00768755|E4|Reported Event|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345513|NCT00768755|E3|Reported Event|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345514|NCT00768755|E2|Reported Event|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
345515|NCT00768755|E1|Reported Event|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
345516|NCT00768651|B1|Baseline|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
345517|NCT00768651|P1|Participant Flow|Sitagliptin + Pantoprazole|"Intervention Details:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout."
345518|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
345519|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
345520|NCT00768651|E1|Reported Event|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
345521|NCT00768599|B4|Baseline|Total|Total of all reporting groups
345522|NCT00768599|B3|Baseline|Control|Vehicle Foam
345523|NCT00768599|B2|Baseline|Test Drug|Econazole Nitrate Foam 1%
345524|NCT00768599|B1|Baseline|Reference Drug|Econazole Nitrate Cream 1%
345548|NCT00768599|E1|Reported Event|Reference Drug|Econazole Nitrate Cream 1%
345549|NCT00768560|B7|Baseline|Total|Total of all reporting groups
345550|NCT00768560|B6|Baseline|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
345551|NCT00768560|B5|Baseline|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
345552|NCT00768560|B4|Baseline|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
345553|NCT00768560|B3|Baseline|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
345554|NCT00768560|B2|Baseline|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
345555|NCT00768560|B1|Baseline|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
345556|NCT00768560|P6|Participant Flow|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
345557|NCT00768560|P5|Participant Flow|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
345558|NCT00768560|P4|Participant Flow|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
345559|NCT00768560|P3|Participant Flow|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
345560|NCT00768560|P2|Participant Flow|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
345561|NCT00768560|P1|Participant Flow|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
345562|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345563|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345564|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345565|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345566|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345567|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345568|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345569|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345570|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345571|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345572|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345573|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345574|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345575|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345576|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345577|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345578|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345579|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345580|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345581|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345582|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345583|NCT00768560|E3|Reported Event|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
345584|NCT00768560|E2|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
345585|NCT00768560|E1|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
345586|NCT00768521|B1|Baseline|All Participants|All Study Participants from all groups.
345587|NCT00768521|P2|Participant Flow|Placebo Then Tolterodine|Placebo then Tolterodine 4 mg
345588|NCT00768521|P1|Participant Flow|Tolterodine Then Placebo|Tolterodine 4 mg then Placebo
345589|NCT00768521|O2|Outcome|Placebo|
345590|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
345591|NCT00768521|O2|Outcome|Placebo|
345592|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
345593|NCT00768521|E2|Reported Event|Placebo|
345594|NCT00768521|E1|Reported Event|Tolterodine|Tolterodine 4 mg
345595|NCT00768430|B3|Baseline|Total|Total of all reporting groups
345596|NCT00768430|B2|Baseline|Midazolam|Midazolam
345597|NCT00768430|B1|Baseline|Ketamine|Ketamine
345598|NCT00768430|P2|Participant Flow|Midazolam|single infusion of midazolam being used as an active control for the study
345599|NCT00768430|P1|Participant Flow|Ketamine|single infusion of 0.5mg/kg of Ketamine HCL
345600|NCT00768430|O2|Outcome|Midazolam|Midazolam
345601|NCT00768430|O1|Outcome|Ketamine|Ketamine
345602|NCT00768430|E2|Reported Event|Midazolam|Midazolam
345603|NCT00768430|E1|Reported Event|Ketamine|Ketamine
345605|NCT00768300|B2|Baseline|Placebo|Placebo to match ambrisentan administered orally once daily
345606|NCT00768300|B1|Baseline|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345607|NCT00768300|P2|Participant Flow|Placebo|Placebo to match ambrisentan administered orally once daily
345608|NCT00768300|P1|Participant Flow|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345609|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345610|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345611|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345612|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345613|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345614|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345615|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345616|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345617|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345618|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345619|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345620|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345621|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345622|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345623|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345624|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345625|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
345626|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345627|NCT00768300|E2|Reported Event|Placebo|Placebo to match ambrisentan administered orally once daily
345628|NCT00768300|E1|Reported Event|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
345629|NCT00768222|B3|Baseline|Total|Total of all reporting groups
345630|NCT00768222|B2|Baseline|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345631|NCT00768222|B1|Baseline|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345632|NCT00768222|P2|Participant Flow|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345633|NCT00768222|P1|Participant Flow|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345634|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345635|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345636|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345637|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345638|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345639|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345640|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345641|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345642|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345643|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345644|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345645|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345646|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345647|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345648|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345649|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345650|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345651|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345652|NCT00768222|E2|Reported Event|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
345653|NCT00768222|E1|Reported Event|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
345654|NCT00768144|B1|Baseline|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
345655|NCT00768144|P1|Participant Flow|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
345656|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
345657|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
345658|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
345659|NCT00768144|E1|Reported Event|Sunitinib|Sunitinib : Taken orally once a day in the evening
345660|NCT00768118|B1|Baseline|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
345661|NCT00768118|P1|Participant Flow|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
345662|NCT00768118|O1|Outcome|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
345663|NCT00768118|E1|Reported Event|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
345664|NCT00768066|B4|Baseline|Total|Total of all reporting groups
345665|NCT00768066|B3|Baseline|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345666|NCT00768066|B2|Baseline|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345667|NCT00768066|B1|Baseline|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345668|NCT00768066|P3|Participant Flow|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345669|NCT00768066|P2|Participant Flow|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345670|NCT00768066|P1|Participant Flow|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345671|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345720|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
346465|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
345672|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345673|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345674|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345675|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345676|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345677|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345678|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345679|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345680|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345681|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345682|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345683|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345684|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345685|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345686|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345687|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345688|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345689|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345690|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345691|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345692|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345693|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345694|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345695|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345696|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345697|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345698|NCT00768066|E3|Reported Event|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345699|NCT00768066|E2|Reported Event|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345700|NCT00768066|E1|Reported Event|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
345701|NCT00768053|B1|Baseline|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345702|NCT00768053|P1|Participant Flow|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345703|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345704|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345705|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345706|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345707|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345708|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345709|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345710|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345711|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345712|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345713|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345714|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345715|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345716|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345717|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345718|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345719|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
347419|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
345721|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345722|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345723|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345724|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345725|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345726|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345727|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345728|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345729|NCT00768053|E1|Reported Event|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
345730|NCT00768040|B3|Baseline|Total|Total of all reporting groups
345731|NCT00768040|B2|Baseline|Placebo|Matching placebo once daily for 12 weeks
345732|NCT00768040|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
345733|NCT00768040|P2|Participant Flow|Placebo|Matching placebo once daily for 12 weeks
345734|NCT00768040|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
345735|NCT00768040|O2|Outcome|Placebo|Matching placebo once daily for 12 weeks
345736|NCT00768040|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
345737|NCT00768040|E2|Reported Event|Placebo|Matching placebo once daily for 12 weeks
345738|NCT00768040|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg once daily for 12 weeks
345739|NCT00767806|B3|Baseline|Total|Total of all reporting groups
345740|NCT00767806|B2|Baseline|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345741|NCT00767806|B1|Baseline|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345742|NCT00767806|P2|Participant Flow|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345743|NCT00767806|P1|Participant Flow|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345744|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345745|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345746|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345747|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345748|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345749|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345750|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345751|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345752|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345753|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345754|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345755|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345756|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345757|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345758|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345759|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345760|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345761|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345762|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345763|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345764|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345765|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345766|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345767|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345768|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345769|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345770|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345771|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
347477|NCT00763282|B3|Baseline|Total|Total of all reporting groups
345772|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345773|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345774|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345775|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345776|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345777|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345778|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345779|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345780|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345781|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345782|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345783|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345784|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345785|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345786|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345787|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345788|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345789|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345790|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345791|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345792|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345793|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345794|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345795|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345796|NCT00767806|E2|Reported Event|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
345797|NCT00767806|E1|Reported Event|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
345798|NCT00767676|B1|Baseline|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
345799|NCT00767676|P1|Participant Flow|HP828-101|HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
345800|NCT00767676|O1|Outcome|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
345801|NCT00767676|E1|Reported Event|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
345802|NCT00767624|B3|Baseline|Total|Total of all reporting groups
345803|NCT00767624|B2|Baseline|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
345804|NCT00767624|B1|Baseline|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
345805|NCT00767624|P2|Participant Flow|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
345806|NCT00767624|P1|Participant Flow|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
345807|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
345808|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
345809|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
345810|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
345993|NCT00767000|E5|Reported Event|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345811|NCT00767624|E2|Reported Event|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
345812|NCT00767624|E1|Reported Event|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
345813|NCT00767572|B1|Baseline|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
345814|NCT00767572|P1|Participant Flow|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
345815|NCT00767572|O2|Outcome|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
345816|NCT00767572|O1|Outcome|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
345817|NCT00767572|E2|Reported Event|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
345818|NCT00767572|E1|Reported Event|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
345819|NCT00767520|B3|Baseline|Total|Total of all reporting groups
345820|NCT00767520|B2|Baseline|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345821|NCT00767520|B1|Baseline|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345822|NCT00767520|P2|Participant Flow|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345823|NCT00767520|P1|Participant Flow|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345824|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345825|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345826|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345827|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345828|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345829|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345830|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345831|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345832|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345833|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345834|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345835|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345836|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345837|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345838|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345839|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345840|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345841|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345842|NCT00767520|E2|Reported Event|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
345843|NCT00767520|E1|Reported Event|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
345844|NCT00767507|B5|Baseline|Total|Total of all reporting groups
345845|NCT00767507|B4|Baseline|Stage II Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345846|NCT00767507|B3|Baseline|Stage II Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345847|NCT00767507|B2|Baseline|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345848|NCT00767507|B1|Baseline|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345849|NCT00767507|P4|Participant Flow|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345850|NCT00767507|P3|Participant Flow|Stage II - Cangrelor Arm (0.75 mcg/kg/Min )|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345851|NCT00767507|P2|Participant Flow|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345852|NCT00767507|P1|Participant Flow|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345853|NCT00767507|O4|Outcome|Stage I - Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345854|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor (0.5 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345855|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345856|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345857|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345858|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345859|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345860|NCT00767507|O1|Outcome|Stage II - Cangrelor (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345861|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345862|NCT00767507|O3|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345863|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345864|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345865|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345866|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345867|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received m as a matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345868|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345869|NCT00767507|O2|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345870|NCT00767507|O1|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345871|NCT00767507|E4|Reported Event|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345872|NCT00767507|E3|Reported Event|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345873|NCT00767507|E2|Reported Event|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345874|NCT00767507|E1|Reported Event|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
345875|NCT00767455|B1|Baseline|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
345876|NCT00767455|P1|Participant Flow|HP828-101 vs. Negative Control vs. Positive Control|Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
345877|NCT00767455|O3|Outcome|Positive Control|Sodium Lauryl Sulfate
345878|NCT00767455|O2|Outcome|Negative Control|Johnson's Baby Oil
345879|NCT00767455|O1|Outcome|HP828-101|Intervention test article
345880|NCT00767455|E1|Reported Event|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
345881|NCT00767364|B3|Baseline|Total|Total of all reporting groups
345882|NCT00767364|B2|Baseline|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345883|NCT00767364|B1|Baseline|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345884|NCT00767364|P2|Participant Flow|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345885|NCT00767364|P1|Participant Flow|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345886|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345887|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345888|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345889|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345890|NCT00767364|E2|Reported Event|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345891|NCT00767364|E1|Reported Event|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
345892|NCT00767338|B5|Baseline|Total|Total of all reporting groups
345893|NCT00767338|B4|Baseline|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345894|NCT00767338|B3|Baseline|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345895|NCT00767338|B2|Baseline|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345896|NCT00767338|B1|Baseline|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345897|NCT00767338|P4|Participant Flow|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345898|NCT00767338|P3|Participant Flow|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345899|NCT00767338|P2|Participant Flow|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345900|NCT00767338|P1|Participant Flow|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345901|NCT00767338|O4|Outcome|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345902|NCT00767338|O3|Outcome|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345903|NCT00767338|O2|Outcome|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345904|NCT00767338|O1|Outcome|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345905|NCT00767338|E4|Reported Event|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345906|NCT00767338|E3|Reported Event|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345907|NCT00767338|E2|Reported Event|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
345908|NCT00767338|E1|Reported Event|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
345909|NCT00767325|B1|Baseline|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345910|NCT00767325|P1|Participant Flow|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345911|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345912|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345913|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345914|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345915|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345916|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
345917|NCT00767325|E1|Reported Event|Aba 10 mg/kg|
345918|NCT00767039|B3|Baseline|Total|Total of all reporting groups
345919|NCT00767039|B2|Baseline|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345920|NCT00767039|B1|Baseline|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345921|NCT00767039|P2|Participant Flow|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345922|NCT00767039|P1|Participant Flow|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345923|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345924|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345925|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345926|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345927|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345928|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345929|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345930|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345931|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345932|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345933|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345934|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345935|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345936|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345937|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345938|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345939|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345940|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345941|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345942|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345994|NCT00767000|E4|Reported Event|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345943|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345944|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345945|NCT00767039|E2|Reported Event|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
345946|NCT00767039|E1|Reported Event|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
345947|NCT00767000|B6|Baseline|Total|Total of all reporting groups
345948|NCT00767000|B5|Baseline|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345949|NCT00767000|B4|Baseline|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345950|NCT00767000|B3|Baseline|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345951|NCT00767000|B2|Baseline|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345952|NCT00767000|B1|Baseline|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345953|NCT00767000|P5|Participant Flow|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345954|NCT00767000|P4|Participant Flow|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345955|NCT00767000|P3|Participant Flow|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345956|NCT00767000|P2|Participant Flow|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345957|NCT00767000|P1|Participant Flow|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345958|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345959|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345960|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345961|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345962|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345963|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345964|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345965|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345966|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345967|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345968|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345969|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345970|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345971|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345972|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345973|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345974|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345975|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345976|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345977|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345978|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345979|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345980|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345981|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345982|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345983|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345984|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345985|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345986|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345987|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345988|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
345989|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
345990|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345991|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345992|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345995|NCT00767000|E3|Reported Event|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
345996|NCT00767000|E2|Reported Event|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
345997|NCT00767000|E1|Reported Event|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
345998|NCT00766831|B1|Baseline|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
345999|NCT00766831|P1|Participant Flow|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346000|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346001|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346002|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346003|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346004|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346005|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346006|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346007|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346008|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346009|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346010|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346011|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346012|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346013|NCT00766831|E1|Reported Event|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
346014|NCT00766675|B1|Baseline|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346015|NCT00766675|P1|Participant Flow|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346016|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346017|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346018|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346019|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346020|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346021|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346022|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346023|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346024|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346025|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346026|NCT00766675|E1|Reported Event|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
346027|NCT00766649|B1|Baseline|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346028|NCT00766649|P1|Participant Flow|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346029|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346030|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346031|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346032|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346033|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346034|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346035|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346036|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346037|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346038|NCT00766649|E1|Reported Event|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
346039|NCT00766636|B3|Baseline|Total|Total of all reporting groups
346040|NCT00766636|B2|Baseline|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
346041|NCT00766636|B1|Baseline|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
346152|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346153|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346154|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346155|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346042|NCT00766636|P2|Participant Flow|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
346043|NCT00766636|P1|Participant Flow|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
346044|NCT00766636|O2|Outcome|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
346045|NCT00766636|O1|Outcome|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
346046|NCT00766636|E2|Reported Event|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
346047|NCT00766636|E1|Reported Event|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
346048|NCT00766597|B1|Baseline|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346049|NCT00766597|P1|Participant Flow|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346050|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346051|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346052|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346053|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346054|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346055|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346056|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346057|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
346058|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic virus
346059|NCT00766597|E1|Reported Event|Vicriviroc in Tablet Form (20/30mg) or Liquid Form (1mg/ml)|Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
346060|NCT00766532|B1|Baseline|Group 1|
346061|NCT00766532|P1|Participant Flow|Arm Title- Aromatase Inhibitor Therapy|calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
346062|NCT00766532|O1|Outcome|Aromatase Inhibitor Therapy|
346063|NCT00766532|E1|Reported Event|Group 1|
346064|NCT00766506|B3|Baseline|Total|Total of all reporting groups
346065|NCT00766506|B2|Baseline|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346066|NCT00766506|B1|Baseline|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346067|NCT00766506|P2|Participant Flow|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346068|NCT00766506|P1|Participant Flow|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346069|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346070|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346071|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346072|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346073|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346074|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346075|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346076|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346077|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346078|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346079|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346080|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346081|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346082|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346083|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346084|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346085|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346156|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346157|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346158|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346086|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346087|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346088|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346089|NCT00766506|E2|Reported Event|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
346090|NCT00766506|E1|Reported Event|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
346091|NCT00766493|B1|Baseline|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346092|NCT00766493|P1|Participant Flow|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346093|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346094|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346095|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346096|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346097|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346098|NCT00766493|E1|Reported Event|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
346099|NCT00766467|B3|Baseline|Total|Total of all reporting groups
346100|NCT00766467|B2|Baseline|Placebo|Placebo: Taken orally once a day in the morning.
346101|NCT00766467|B1|Baseline|Armodafinil|Armodafinil: Taken orally once a day in the morning.
346102|NCT00766467|P2|Participant Flow|Placebo|Placebo: Taken orally once a day in the morning
346103|NCT00766467|P1|Participant Flow|Armodafinil|Armodafinil: 150mg taken orally once a day in the morning.
346104|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
346105|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
346106|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
346107|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
346108|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
346109|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
346110|NCT00766467|E2|Reported Event|Placebo|Placebo: Taken orally once a day in the morning.
346111|NCT00766467|E1|Reported Event|Armodafinil|Armodafinil: Taken orally once a day in the morning.
346112|NCT00766415|B3|Baseline|Total|Total of all reporting groups
346113|NCT00766415|B2|Baseline|Placebo|Placebo, twice daily
346114|NCT00766415|B1|Baseline|AZD1981|AZD1981 1000 mg, twice daily
346115|NCT00766415|P2|Participant Flow|Placebo|Placebo, twice daily
346116|NCT00766415|P1|Participant Flow|AZD1981|AZD1981 1000 mg, twice daily
346117|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346118|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346119|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346120|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346121|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346122|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346123|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346124|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346125|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346126|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346127|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346128|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346129|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346130|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346131|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346132|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346133|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346134|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346135|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346136|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346137|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346138|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346139|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346140|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346141|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346142|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346143|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346144|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346145|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346146|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346147|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346148|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346149|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346150|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
346151|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
346163|NCT00766376|B1|Baseline|Erbium Laser|Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
346164|NCT00766376|P1|Participant Flow|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
346165|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
346166|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
346167|NCT00766376|E1|Reported Event|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
346168|NCT00766363|B5|Baseline|Total|Total of all reporting groups
346169|NCT00766363|B4|Baseline|Placebo|1 capsule per day for 28 days.
346170|NCT00766363|B3|Baseline|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346171|NCT00766363|B2|Baseline|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346172|NCT00766363|B1|Baseline|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346173|NCT00766363|P4|Participant Flow|Placebo|1 capsule per day for 28 days.
346174|NCT00766363|P3|Participant Flow|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346175|NCT00766363|P2|Participant Flow|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346176|NCT00766363|P1|Participant Flow|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346177|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346178|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346179|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346180|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346181|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346182|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346183|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
346184|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346185|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346186|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346187|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
346188|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346189|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346190|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346191|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
346192|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346193|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346194|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346195|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346196|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346197|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346198|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346199|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346200|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346201|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346202|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346203|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346204|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
346205|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346206|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346207|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346208|NCT00766363|E4|Reported Event|Placebo|1 capsule per day for 28 days.
346209|NCT00766363|E3|Reported Event|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
346210|NCT00766363|E2|Reported Event|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
346211|NCT00766363|E1|Reported Event|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
346212|NCT00766090|B3|Baseline|Total|Total of all reporting groups
346213|NCT00766090|B2|Baseline|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346214|NCT00766090|B1|Baseline|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346300|NCT00765882|P2|Participant Flow|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346215|NCT00766090|P12|Participant Flow|Sequence 12: FP 200 µg, FP 100 µg, Placebo|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346216|NCT00766090|P11|Participant Flow|Sequence 11: FP 200 µg, Placebo, FP 100 µg|Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346217|NCT00766090|P10|Participant Flow|Sequence 10: FP 100 µg, FP 200 µg, Placebo|Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346218|NCT00766090|P9|Participant Flow|Sequence 9: FP 100 µg, Placebo, FP 200 µg|Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346219|NCT00766090|P8|Participant Flow|Sequence 8: Placebo, FP 100 µg, FP 200 µg|Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346220|NCT00766090|P7|Participant Flow|Sequence 7: Placebo, FP 200 µg, FP 100 µg|Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346221|NCT00766090|P6|Participant Flow|Sequence 6: FF 200 µg, FF 100 µg, Placebo|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346222|NCT00766090|P5|Participant Flow|Sequence 5: FF 200 µg, Placebo, FF 100 µg|Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346223|NCT00766090|P4|Participant Flow|Sequence 4: FF 100 µg, FF 200 µg, Placebo|Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346224|NCT00766090|P3|Participant Flow|Sequence 3: FF 100 µg, Placebo, FF 200 µg|Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346225|NCT00766090|P2|Participant Flow|Sequence 2: Placebo, FF 100 µg, FF 200 µg|Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346226|NCT00766090|P1|Participant Flow|Sequence 1: Placebo, FF 200 µg, FF 100 µg|Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346227|NCT00766090|O2|Outcome|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346228|NCT00766090|O1|Outcome|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346301|NCT00765882|P1|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day.
346229|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346230|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346231|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346232|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346233|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346234|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346235|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346236|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346237|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346238|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346239|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346240|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346241|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346242|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346243|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346244|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346245|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346246|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346247|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346248|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
347683|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
346249|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346250|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346251|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346252|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346253|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346254|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346255|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346256|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346257|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346258|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346259|NCT00766090|E5|Reported Event|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346260|NCT00766090|E4|Reported Event|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346261|NCT00766090|E3|Reported Event|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346262|NCT00766090|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346263|NCT00766090|E1|Reported Event|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
346264|NCT00766051|B3|Baseline|Total|Total of all reporting groups
346265|NCT00766051|B2|Baseline|Intervention Group|This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
346266|NCT00766051|B1|Baseline|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
346267|NCT00766051|P2|Participant Flow|Matched Historical Comparison Group|Matched Historical Controls drawn from a three year period.
346268|NCT00766051|P1|Participant Flow|Intervention Group|This is the only intervention group that the analysis apply to.
346269|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
346270|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
346271|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
346302|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346272|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
346273|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
346274|NCT00766051|O2|Outcome|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
346275|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
346276|NCT00766051|E1|Reported Event|Intervention Group|This is the only intervention group that the analysis apply to.
346277|NCT00765947|B1|Baseline|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346278|NCT00765947|P1|Participant Flow|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346279|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346280|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346281|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346282|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
346283|NCT00765947|E3|Reported Event|Aliskiren + HCTZ + Amlodipine|Aliskiren + HCTZ + Amlodipine treatment step
346284|NCT00765947|E2|Reported Event|Aliskiren + HCTZ|Aliskiren and HCTZ treatment step
346285|NCT00765947|E1|Reported Event|Aliskiren|Aliskiren treatment step
346286|NCT00765895|B3|Baseline|Total|Total of all reporting groups
346287|NCT00765895|B2|Baseline|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346288|NCT00765895|B1|Baseline|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346289|NCT00765895|P2|Participant Flow|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346290|NCT00765895|P1|Participant Flow|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346291|NCT00765895|O2|Outcome|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346292|NCT00765895|O1|Outcome|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346293|NCT00765895|E2|Reported Event|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346294|NCT00765895|E1|Reported Event|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
346295|NCT00765882|B4|Baseline|Total|Total of all reporting groups
346296|NCT00765882|B3|Baseline|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346297|NCT00765882|B2|Baseline|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346298|NCT00765882|B1|Baseline|Placebo|Dose matched placebo, oral administration, once per day.
346299|NCT00765882|P3|Participant Flow|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346303|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346304|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346305|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346306|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346307|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346308|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346309|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346310|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346311|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346312|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346313|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346314|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346315|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346316|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346317|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346318|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346319|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346320|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346321|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346322|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346323|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346324|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346325|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
346326|NCT00765882|E3|Reported Event|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
346327|NCT00765882|E2|Reported Event|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
346328|NCT00765882|E1|Reported Event|Placebo|Dose matched placebo, oral administration, once per day.
346329|NCT00765843|B4|Baseline|Total|Total of all reporting groups
346330|NCT00765843|B3|Baseline|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346331|NCT00765843|B2|Baseline|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346332|NCT00765843|B1|Baseline|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346333|NCT00765843|P3|Participant Flow|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346334|NCT00765843|P2|Participant Flow|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346335|NCT00765843|P1|Participant Flow|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346336|NCT00765843|O3|Outcome|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346337|NCT00765843|O2|Outcome|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346338|NCT00765843|O1|Outcome|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346339|NCT00765843|E3|Reported Event|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346340|NCT00765843|E2|Reported Event|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346341|NCT00765843|E1|Reported Event|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
346343|NCT00765817|B2|Baseline|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346344|NCT00765817|B1|Baseline|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346345|NCT00765817|P2|Participant Flow|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346346|NCT00765817|P1|Participant Flow|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346347|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346348|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346349|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346350|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346351|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346352|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346353|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346354|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346355|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346356|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346357|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346358|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346359|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346360|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346361|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346362|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346363|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346364|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346365|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346366|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346367|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346368|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346369|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346370|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346371|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346372|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346373|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346374|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346375|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346376|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346377|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346378|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346379|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346380|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346381|NCT00765817|E2|Reported Event|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
346382|NCT00765817|E1|Reported Event|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
346383|NCT00765765|B1|Baseline|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346384|NCT00765765|P1|Participant Flow|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346385|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346386|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346387|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346388|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346389|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346390|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346391|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346392|NCT00765765|E1|Reported Event|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
346393|NCT00765726|B1|Baseline|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
346394|NCT00765726|P1|Participant Flow|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
346395|NCT00765726|O1|Outcome|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
346396|NCT00765726|E1|Reported Event|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
346397|NCT00765674|B5|Baseline|Total|Total of all reporting groups
346398|NCT00765674|B4|Baseline|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346399|NCT00765674|B3|Baseline|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346400|NCT00765674|B2|Baseline|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346401|NCT00765674|B1|Baseline|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
347684|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
346402|NCT00765674|P4|Participant Flow|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346403|NCT00765674|P3|Participant Flow|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346404|NCT00765674|P2|Participant Flow|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346405|NCT00765674|P1|Participant Flow|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346406|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346407|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346408|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346409|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346410|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346411|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346412|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346413|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346597|NCT00765076|P2|Participant Flow|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346414|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346415|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346416|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346417|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346418|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346419|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346420|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346421|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346422|NCT00765674|E4|Reported Event|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346423|NCT00765674|E3|Reported Event|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
346424|NCT00765674|E2|Reported Event|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346425|NCT00765674|E1|Reported Event|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
346426|NCT00765661|B3|Baseline|Total|Total of all reporting groups
346427|NCT00765661|B2|Baseline|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily, orally"
346428|NCT00765661|B1|Baseline|Gorup A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets, orally"
346429|NCT00765661|P2|Participant Flow|Group B|Randomized, parallel-group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of Prograf capsules in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive Prograf capsules in 2 equally divided doses, starting at 0.1 mg/kg every 12 hours (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information
346430|NCT00765661|P1|Participant Flow|Group A|Randomized, parallel group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24 +/-1 hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg)
346431|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
346432|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
346433|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
346434|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
346435|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
346436|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
346437|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
346438|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
346439|NCT00765661|E2|Reported Event|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily"
346440|NCT00765661|E1|Reported Event|Group A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets"
346441|NCT00765648|B3|Baseline|Total|Total of all reporting groups
346442|NCT00765648|B2|Baseline|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
346443|NCT00765648|B1|Baseline|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
346444|NCT00765648|P2|Participant Flow|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
346445|NCT00765648|P1|Participant Flow|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
346446|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346447|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346448|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346449|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346450|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346451|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346452|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346453|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346454|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346455|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346456|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
346457|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
346458|NCT00765648|E2|Reported Event|Labetalol|Bolus Labetalol began at 20 mg over 2 minutes
346459|NCT00765648|E1|Reported Event|Nicardipine|Nicardipine dosing was 5 mg/hour
346460|NCT00765570|B3|Baseline|Total|Total of all reporting groups
346461|NCT00765570|B2|Baseline|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
346462|NCT00765570|B1|Baseline|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
346463|NCT00765570|P2|Participant Flow|Treatment Group-2|Treatment Group 2:15 treatments with standard radiation
346464|NCT00765570|P1|Participant Flow|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
346466|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
346467|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
346468|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
346469|NCT00765570|E2|Reported Event|Treatment Group-2|Treatment Group 2-15 treatments with standard radiation
346470|NCT00765570|E1|Reported Event|Treatment Group 1|Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
346471|NCT00765388|B1|Baseline|Entire Study Population|Includes groups randomized to receive SenSura Uro first and Hollister Uro first
346472|NCT00765388|P2|Participant Flow|SenSura Uro First, Then Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346473|NCT00765388|P1|Participant Flow|Hollister Uro First, Then SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346474|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346475|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346476|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346477|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346478|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346479|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346480|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346481|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346482|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346483|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346484|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346485|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346486|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346487|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346488|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346489|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346490|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346491|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346492|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346493|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346494|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346495|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346496|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346497|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346498|NCT00765388|E2|Reported Event|SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346499|NCT00765388|E1|Reported Event|Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
346500|NCT00765375|B1|Baseline|Active on One Side and Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
346501|NCT00765375|P1|Participant Flow|Active on One Side, Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
346502|NCT00765375|O2|Outcome|2- Placebo|Saline Solution
346503|NCT00765375|O1|Outcome|1- Active|Botulinum Neurotoxin Type A (Botox)
346504|NCT00765375|E2|Reported Event|2- Placebo|Saline Solution
346505|NCT00765375|E1|Reported Event|1- Active|Botulinum Neurotoxin Type A (Botox)
346506|NCT00765362|B1|Baseline|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346567|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346568|NCT00765128|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346599|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346507|NCT00765362|P1|Participant Flow|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346508|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346509|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346510|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346511|NCT00765362|E1|Reported Event|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
346512|NCT00765336|B3|Baseline|Total|Total of all reporting groups
346513|NCT00765336|B2|Baseline|Placebo|daily dose of Placebo
346514|NCT00765336|B1|Baseline|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
346515|NCT00765336|P2|Participant Flow|Placebo|daily dose of Placebo
346516|NCT00765336|P1|Participant Flow|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
346517|NCT00765336|O2|Outcome|Placebo|daily dose of Placebo
346518|NCT00765336|O1|Outcome|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
346519|NCT00765336|E2|Reported Event|Placebo|daily dose of Placebo
346520|NCT00765336|E1|Reported Event|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
346521|NCT00765245|B3|Baseline|Total|Total of all reporting groups
346522|NCT00765245|B2|Baseline|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346523|NCT00765245|B1|Baseline|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346524|NCT00765245|P2|Participant Flow|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346525|NCT00765245|P1|Participant Flow|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346526|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346527|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346528|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346529|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346569|NCT00765128|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346598|NCT00765076|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346530|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346531|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346532|NCT00765245|E2|Reported Event|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
346533|NCT00765245|E1|Reported Event|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
346534|NCT00765232|B3|Baseline|Total|Total of all reporting groups
346535|NCT00765232|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346536|NCT00765232|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346537|NCT00765232|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346538|NCT00765232|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346539|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346540|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346541|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346542|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346543|NCT00765232|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346544|NCT00765232|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346545|NCT00765206|B1|Baseline|Entire Study Population|
346546|NCT00765206|P4|Participant Flow|Prilosec First, Then Zegerid (7-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
346547|NCT00765206|P3|Participant Flow|Zegerid First, Then Prilosec ( 7-Day Dosing)|Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
346548|NCT00765206|P2|Participant Flow|Prilosec First, Then Zegerid (1-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
346549|NCT00765206|P1|Participant Flow|Zegerid First, Then Prilosec (1- Day Dosing)|Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
346550|NCT00765206|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
346551|NCT00765206|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
346552|NCT00765206|E2|Reported Event|Prilosec|Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
346553|NCT00765206|E1|Reported Event|Zegerid|Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
346554|NCT00765193|B1|Baseline|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
346555|NCT00765193|P1|Participant Flow|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
346556|NCT00765193|O2|Outcome|Full Body Examination|
346557|NCT00765193|O1|Outcome|Problem Area Examination|
346558|NCT00765193|E1|Reported Event|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
346559|NCT00765128|B3|Baseline|Total|Total of all reporting groups
346560|NCT00765128|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346561|NCT00765128|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346562|NCT00765128|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346563|NCT00765128|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346564|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346565|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346566|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
346570|NCT00765102|B1|Baseline|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346571|NCT00765102|P1|Participant Flow|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346572|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346573|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346574|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346575|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346576|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346577|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346578|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346579|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346580|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346581|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346582|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346583|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346584|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346585|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346586|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346587|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
346588|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
346589|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346590|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346591|NCT00765102|E1|Reported Event|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
346592|NCT00765076|B4|Baseline|Total|Total of all reporting groups
346593|NCT00765076|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346594|NCT00765076|B2|Baseline|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346595|NCT00765076|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346596|NCT00765076|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
347685|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
346600|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346601|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346602|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346603|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346604|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346605|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346606|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346607|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346608|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346609|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346610|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346611|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346612|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346613|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346614|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346615|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346616|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346617|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346618|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346619|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346620|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346621|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346622|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346623|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346624|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346625|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346626|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346627|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346628|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346629|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346630|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346631|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346632|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346633|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346634|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346635|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346636|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346637|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346638|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346639|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346640|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346641|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346642|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346643|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346644|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346645|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346646|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346647|NCT00765076|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
346648|NCT00765076|E2|Reported Event|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
346649|NCT00765076|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
346650|NCT00765063|B1|Baseline|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346651|NCT00765063|P1|Participant Flow|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346652|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346653|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346654|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346655|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346656|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346657|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346658|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346659|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346660|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346661|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346662|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346663|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346664|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346665|NCT00765063|E1|Reported Event|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
346666|NCT00765037|B1|Baseline|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
346667|NCT00765037|P1|Participant Flow|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
346668|NCT00765037|O1|Outcome|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
346669|NCT00765037|E1|Reported Event|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
346670|NCT00764946|B4|Baseline|Total|Total of all reporting groups
346671|NCT00764946|B3|Baseline|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346672|NCT00764946|B2|Baseline|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346673|NCT00764946|B1|Baseline|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346674|NCT00764946|P3|Participant Flow|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346675|NCT00764946|P2|Participant Flow|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346676|NCT00764946|P1|Participant Flow|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
346677|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346678|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346679|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346680|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346681|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346682|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346683|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346684|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346685|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346686|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346687|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346688|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346689|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346690|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346691|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346692|NCT00764946|O3|Outcome|Treatment Naive|
346693|NCT00764946|O2|Outcome|Treatment-Experienced - Treatment Intolerant|
346694|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|
346695|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346696|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346697|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346698|NCT00764946|E3|Reported Event|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346699|NCT00764946|E2|Reported Event|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346700|NCT00764946|E1|Reported Event|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
346701|NCT00764881|B3|Baseline|Total|Total of all reporting groups
346702|NCT00764881|B2|Baseline|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346703|NCT00764881|B1|Baseline|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346704|NCT00764881|P2|Participant Flow|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346705|NCT00764881|P1|Participant Flow|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346706|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346707|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346708|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346709|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346710|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346711|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346712|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346713|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346714|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346715|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346716|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346717|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346718|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346719|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346720|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346721|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346722|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346723|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346724|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346725|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346726|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346727|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346728|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346729|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346730|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346731|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346732|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346733|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346734|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346735|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346736|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346737|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346738|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346739|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346740|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346741|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346742|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346743|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346744|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346745|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346746|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346747|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346748|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346749|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346750|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346751|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346752|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346753|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346754|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346755|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346756|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346757|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346758|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346759|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346760|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346761|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346762|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346763|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346764|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346765|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346766|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346767|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346768|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346769|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346770|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346771|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346772|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346773|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346774|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346775|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346776|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346777|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346778|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346779|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346780|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346781|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346782|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346783|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346784|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346785|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346786|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346787|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346788|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346789|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346790|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346791|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346792|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346793|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346794|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346795|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346796|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346797|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346798|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346799|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346800|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346801|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346802|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346803|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346804|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346805|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346806|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346807|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346808|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346809|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346810|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346811|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346812|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346813|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346814|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346815|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346816|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346817|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346818|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346819|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346820|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346821|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346822|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346823|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346824|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346825|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346826|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346827|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346828|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346829|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346830|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346831|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346832|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346833|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346834|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346835|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346836|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346837|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346838|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346839|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346840|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346841|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346842|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346843|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346844|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346845|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346846|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346847|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346848|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346849|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346850|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346851|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346852|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346853|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346854|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346855|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346856|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346857|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346858|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346859|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346860|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346861|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346862|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346863|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346864|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346865|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346866|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346867|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346868|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346869|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346870|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346871|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346872|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346873|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346874|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346875|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346876|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346877|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346878|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346879|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346880|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346881|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346882|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346883|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346884|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346885|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346886|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346887|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346888|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346889|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346890|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346891|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346892|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346893|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346894|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346895|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346896|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346897|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346898|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346899|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346900|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346901|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346902|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346903|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346904|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346905|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346906|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346907|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346908|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346909|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346910|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346911|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346912|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346913|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346914|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346915|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346916|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346917|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346918|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346919|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346920|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346921|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346922|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346923|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346924|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
346925|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
346926|NCT00764881|E2|Reported Event|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
346927|NCT00764881|E1|Reported Event|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
346928|NCT00764868|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
346929|NCT00764868|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
346930|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
346931|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
346932|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
347041|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
346933|NCT00764868|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
346934|NCT00764790|B4|Baseline|Total|Total of all reporting groups
346935|NCT00764790|B3|Baseline|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346936|NCT00764790|B2|Baseline|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346937|NCT00764790|B1|Baseline|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346938|NCT00764790|P3|Participant Flow|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346939|NCT00764790|P2|Participant Flow|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346940|NCT00764790|P1|Participant Flow|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346941|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346942|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346943|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346944|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346945|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346946|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346947|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346948|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346949|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346950|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346951|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
347089|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347090|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
346952|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346953|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346954|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346955|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346956|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346957|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346958|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346959|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346960|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346961|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346962|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346963|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346964|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346965|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346966|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346967|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346968|NCT00764790|E3|Reported Event|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346969|NCT00764790|E2|Reported Event|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
347091|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347092|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
346970|NCT00764790|E1|Reported Event|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
346971|NCT00764673|B1|Baseline|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346972|NCT00764673|P1|Participant Flow|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346973|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346974|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346975|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346976|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346977|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346978|NCT00764673|E1|Reported Event|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
346979|NCT00764660|B3|Baseline|Total|Total of all reporting groups
346980|NCT00764660|B2|Baseline|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346981|NCT00764660|B1|Baseline|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346982|NCT00764660|P2|Participant Flow|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346983|NCT00764660|P1|Participant Flow|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346984|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346985|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346986|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346987|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346988|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346989|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346990|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346991|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346992|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346993|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346994|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346995|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346996|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346997|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
346998|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
346999|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347000|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347001|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347002|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347003|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347004|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347005|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347006|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347007|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347008|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347009|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347010|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347011|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347012|NCT00764660|E2|Reported Event|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
347013|NCT00764660|E1|Reported Event|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
347014|NCT00764504|B4|Baseline|Total|Total of all reporting groups
347093|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347015|NCT00764504|B3|Baseline|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347016|NCT00764504|B2|Baseline|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347017|NCT00764504|B1|Baseline|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347018|NCT00764504|P3|Participant Flow|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347019|NCT00764504|P2|Participant Flow|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347020|NCT00764504|P1|Participant Flow|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347021|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347022|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347023|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347024|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347025|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347026|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347027|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347028|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347029|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347030|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347031|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347032|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347033|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347034|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347035|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347036|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347037|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347038|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347039|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347040|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347042|NCT00764504|E3|Reported Event|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
347043|NCT00764504|E2|Reported Event|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
347044|NCT00764504|E1|Reported Event|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
347045|NCT00764478|B4|Baseline|Total|Total of all reporting groups
347046|NCT00764478|B3|Baseline|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347047|NCT00764478|B2|Baseline|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347048|NCT00764478|B1|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347049|NCT00764478|P3|Participant Flow|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347050|NCT00764478|P2|Participant Flow|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347051|NCT00764478|P1|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
347052|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347053|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347054|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347055|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347056|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347057|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347058|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347059|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347060|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347061|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347062|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347063|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347064|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347065|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347066|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347067|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347068|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347069|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347070|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347071|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347072|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347073|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347074|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347075|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347076|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347077|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347078|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347079|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347080|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347081|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347082|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347083|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347084|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347085|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347086|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347087|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347088|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347094|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347095|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347096|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347097|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347098|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347099|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347100|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347101|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347102|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347103|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347104|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347105|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347106|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347107|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347108|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347109|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347110|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347111|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347112|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347113|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347114|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347115|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347116|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347117|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347118|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347119|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347120|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347121|NCT00764478|E3|Reported Event|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
347122|NCT00764478|E2|Reported Event|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
347123|NCT00764478|E1|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
347124|NCT00764465|B7|Baseline|Total|Total of all reporting groups
347125|NCT00764465|B6|Baseline|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
347126|NCT00764465|B5|Baseline|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
347127|NCT00764465|B4|Baseline|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
347128|NCT00764465|B3|Baseline|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
347129|NCT00764465|B2|Baseline|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
347130|NCT00764465|B1|Baseline|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
347131|NCT00764465|P6|Participant Flow|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
347132|NCT00764465|P5|Participant Flow|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
347133|NCT00764465|P4|Participant Flow|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
347134|NCT00764465|P3|Participant Flow|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
347135|NCT00764465|P2|Participant Flow|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
347136|NCT00764465|P1|Participant Flow|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
347137|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
347138|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
347139|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
347140|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
347141|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
347142|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
347143|NCT00764465|O6|Outcome|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
347144|NCT00764465|O5|Outcome|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
347145|NCT00764465|O4|Outcome|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
347146|NCT00764465|O3|Outcome|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
347147|NCT00764465|O2|Outcome|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
347148|NCT00764465|O1|Outcome|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
347149|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
347150|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
347151|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
347152|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
347153|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
347154|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
347155|NCT00764465|E6|Reported Event|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
347156|NCT00764465|E5|Reported Event|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
347157|NCT00764465|E4|Reported Event|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
347158|NCT00764465|E3|Reported Event|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
347159|NCT00764465|E2|Reported Event|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
347160|NCT00764465|E1|Reported Event|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
347161|NCT00764361|B3|Baseline|Total|Total of all reporting groups
347162|NCT00764361|B2|Baseline|Placebo|placebo gel
347163|NCT00764361|B1|Baseline|NanoDOX™ Hydrogel|1.0% doxycycline gel
347164|NCT00764361|P2|Participant Flow|Placebo|placebo gel
347165|NCT00764361|P1|Participant Flow|NanoDOX™ Hydrogel|1.0% doxycycline gel
347166|NCT00764361|O2|Outcome|Placebo|placebo gel
347167|NCT00764361|O1|Outcome|NanoDOX™ Hydrogel|1.0% doxycycline monohydrate gel
347168|NCT00764361|E2|Reported Event|Placebo|placebo gel
347169|NCT00764361|E1|Reported Event|NanoDOX™ Hydrogel|1.0% doxycycline gel
347170|NCT00764309|B1|Baseline|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347202|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347171|NCT00764309|P1|Participant Flow|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347172|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347173|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347174|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347175|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
347176|NCT00764309|E1|Reported Event|Dasatinib|
347177|NCT00763971|B4|Baseline|Total|Total of all reporting groups
347178|NCT00763971|B3|Baseline|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347179|NCT00763971|B2|Baseline|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347180|NCT00763971|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347181|NCT00763971|P3|Participant Flow|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347182|NCT00763971|P2|Participant Flow|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347183|NCT00763971|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347184|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347185|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347186|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347187|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347188|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347189|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347190|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347191|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347192|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347193|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347194|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347195|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347196|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347197|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347198|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347199|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347200|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347201|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347203|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347204|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347205|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347206|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347207|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347208|NCT00763971|E3|Reported Event|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
347209|NCT00763971|E2|Reported Event|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
347210|NCT00763971|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
347211|NCT00763958|B3|Baseline|Total|Total of all reporting groups
347212|NCT00763958|B2|Baseline|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
347213|NCT00763958|B1|Baseline|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
347214|NCT00763958|P2|Participant Flow|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
347215|NCT00763958|P1|Participant Flow|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
347216|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
347217|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
347218|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
347219|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
347220|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
347221|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
347222|NCT00763958|E2|Reported Event|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
347223|NCT00763958|E1|Reported Event|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
347224|NCT00763919|B1|Baseline|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347225|NCT00763919|P1|Participant Flow|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347226|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347227|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347228|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347229|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347230|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347231|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347232|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347233|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347234|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347235|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347236|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347280|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347686|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
347237|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347238|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347239|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347240|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347241|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347242|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347243|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347244|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347245|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347246|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347247|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347248|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347249|NCT00763919|E1|Reported Event|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
347250|NCT00763867|B3|Baseline|Total|Total of all reporting groups
347251|NCT00763867|B2|Baseline|Sildenafil|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
347252|NCT00763867|B1|Baseline|Placebo|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
347253|NCT00763867|P2|Participant Flow|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347254|NCT00763867|P1|Participant Flow|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347255|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347256|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347257|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347258|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347259|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347260|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347261|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347262|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347263|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347264|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347265|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347266|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347267|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347268|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347269|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347270|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347271|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347272|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347273|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347274|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347275|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347276|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347277|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347278|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347279|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347281|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347282|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347283|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347284|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347285|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347286|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347287|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347288|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347289|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347290|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347291|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347292|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347293|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347294|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347295|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347296|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347297|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347298|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347299|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347300|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347301|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347302|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347303|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347304|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347305|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347306|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347307|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347308|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347309|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347310|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347311|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347312|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347313|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347314|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347315|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347316|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347317|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347318|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347319|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347320|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347321|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347322|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347323|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347324|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347325|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347326|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347327|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347328|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347329|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347330|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347331|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347332|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347333|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347334|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347335|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347336|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347337|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347338|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347339|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347340|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347341|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347342|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347343|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347344|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347345|NCT00763867|E2|Reported Event|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347346|NCT00763867|E1|Reported Event|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
347347|NCT00763815|B3|Baseline|Total|Total of all reporting groups
347348|NCT00763815|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg once daily QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347349|NCT00763815|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347350|NCT00763815|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347351|NCT00763815|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347352|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347353|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347354|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347355|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347356|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347357|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347358|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347359|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347360|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347361|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347362|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347363|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347364|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347365|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347366|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347367|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347368|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347369|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347370|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
347371|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
347372|NCT00763815|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
347373|NCT00763815|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
347374|NCT00763750|B1|Baseline|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
347375|NCT00763750|P1|Participant Flow|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
347376|NCT00763750|O1|Outcome|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
347377|NCT00763750|E1|Reported Event|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
347378|NCT00763698|B1|Baseline|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
347379|NCT00763698|P1|Participant Flow|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
347380|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Leads|Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
347417|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347381|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
347382|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
347383|NCT00763698|E1|Reported Event|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
347384|NCT00763490|B1|Baseline|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347385|NCT00763490|P1|Participant Flow|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347386|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347387|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347388|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347389|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347390|NCT00763490|E1|Reported Event|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
347391|NCT00763451|B5|Baseline|Total|Total of all reporting groups
347392|NCT00763451|B4|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
347393|NCT00763451|B3|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347394|NCT00763451|B2|Baseline|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
347395|NCT00763451|B1|Baseline|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347396|NCT00763451|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
347397|NCT00763451|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347398|NCT00763451|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
347399|NCT00763451|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
347400|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347401|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347402|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347403|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347404|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347405|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347406|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347407|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347408|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347409|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347410|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347411|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347412|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347413|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347414|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347415|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347416|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347418|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347420|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347421|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
347422|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
347423|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347424|NCT00763451|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
347425|NCT00763451|E5|Reported Event|Lixisenatide One-step Titration|1-step initiation regimen of lixisenatide.
347426|NCT00763451|E4|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
347427|NCT00763451|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
347428|NCT00763451|E2|Reported Event|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo.
347429|NCT00763451|E1|Reported Event|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo.
347430|NCT00763386|B3|Baseline|Total|Total of all reporting groups
347431|NCT00763386|B2|Baseline|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
347432|NCT00763386|B1|Baseline|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
347433|NCT00763386|P2|Participant Flow|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
347434|NCT00763386|P1|Participant Flow|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
347435|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
347436|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
347437|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
347438|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
347439|NCT00763386|E2|Reported Event|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
347440|NCT00763386|E1|Reported Event|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
347441|NCT00763360|B4|Baseline|Total|Total of all reporting groups
347442|NCT00763360|B3|Baseline|Amvisc Plus|Amvisc Plus
347443|NCT00763360|B2|Baseline|Healon|Healon
347444|NCT00763360|B1|Baseline|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347445|NCT00763360|P3|Participant Flow|Amvisc Plus|Amvisc Plus
347446|NCT00763360|P2|Participant Flow|Healon|Healon
347447|NCT00763360|P1|Participant Flow|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347448|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
347449|NCT00763360|O2|Outcome|Healon|Healon
347450|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347451|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
347452|NCT00763360|O2|Outcome|Healon|Healon
347453|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347454|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
347455|NCT00763360|O2|Outcome|Healon|Healon
347456|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347457|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
347458|NCT00763360|O2|Outcome|Healon|Healon
347459|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347460|NCT00763360|E3|Reported Event|Amvisc Plus|Amvisc Plus
347461|NCT00763360|E2|Reported Event|Healon|Healon
347462|NCT00763360|E1|Reported Event|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
347463|NCT00763321|B4|Baseline|Total|Total of all reporting groups
347464|NCT00763321|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
347465|NCT00763321|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
347466|NCT00763321|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
347467|NCT00763321|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
347468|NCT00763321|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
347469|NCT00763321|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
347470|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
347471|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
347472|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
347473|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
347474|NCT00763321|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
347475|NCT00763321|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
347476|NCT00763321|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
347478|NCT00763282|B2|Baseline|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347479|NCT00763282|B1|Baseline|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347480|NCT00763282|P2|Participant Flow|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347481|NCT00763282|P1|Participant Flow|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347482|NCT00763282|O2|Outcome|ED Group|"An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.~The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347483|NCT00763282|O1|Outcome|SM+MI Group|Self Management (SM) + Motivational Interviewing (MI). Motivational Interviewing (MI) is an evidence-based form of counseling to improve behavior change. Self Management (SM) includes: 1) ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
347484|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347485|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347486|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347487|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347488|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347489|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347573|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347490|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347491|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347492|NCT00763282|E2|Reported Event|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
347493|NCT00763282|E1|Reported Event|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
347494|NCT00763269|B3|Baseline|Total|Total of all reporting groups
347495|NCT00763269|B2|Baseline|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347496|NCT00763269|B1|Baseline|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347497|NCT00763269|P2|Participant Flow|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347498|NCT00763269|P1|Participant Flow|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347499|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347500|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347501|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347502|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347503|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347504|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347505|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347506|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347507|NCT00763269|E2|Reported Event|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
347508|NCT00763269|E1|Reported Event|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
347509|NCT00763256|B3|Baseline|Total|Total of all reporting groups
347510|NCT00763256|B2|Baseline|B - Placebo Comparator|fluoride only toothpaste
347511|NCT00763256|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
347512|NCT00763256|P2|Participant Flow|B - Placebo Comparator|fluoride only toothpaste
347513|NCT00763256|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
347514|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
347515|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347516|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
347517|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347518|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
347519|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347520|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
347521|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347522|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
347523|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347524|NCT00763256|E2|Reported Event|B - Placebo Comparator|fluoride only toothpaste
347525|NCT00763256|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
347526|NCT00763139|B1|Baseline|Baseline Characteristics of Participants|participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
347527|NCT00763139|P2|Participant Flow|Pioglitazone 1st, Placebo 2nd|"Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
347528|NCT00763139|P1|Participant Flow|Placebo 1st, Pioglitazone 2nd|"Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
347529|NCT00763139|O4|Outcome|Placebo Phase After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
347530|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
347680|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
347531|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
347532|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
347533|NCT00763139|O4|Outcome|Placebo Phase wk After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks on medication are reported here.
347534|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
347535|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
347536|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
347537|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
347538|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
347539|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
347540|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
347541|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
347542|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
347543|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
347544|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
347545|NCT00763139|E2|Reported Event|Placebo|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
347546|NCT00763139|E1|Reported Event|Pioglitazone|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone
347547|NCT00763061|B3|Baseline|Total|Total of all reporting groups
347548|NCT00763061|B2|Baseline|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347549|NCT00763061|B1|Baseline|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347550|NCT00763061|P2|Participant Flow|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347551|NCT00763061|P1|Participant Flow|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347552|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347553|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347554|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347555|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347556|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347557|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347558|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347559|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347560|NCT00763061|E2|Reported Event|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
347561|NCT00763061|E1|Reported Event|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
347562|NCT00763048|B3|Baseline|Total|Total of all reporting groups
347563|NCT00763048|B2|Baseline|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347564|NCT00763048|B1|Baseline|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347565|NCT00763048|P2|Participant Flow|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347566|NCT00763048|P1|Participant Flow|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347567|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347568|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347569|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347570|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347571|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347572|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347574|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347575|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347576|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347577|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347578|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347579|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347580|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347581|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347582|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347583|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347584|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347585|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347586|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347587|NCT00763048|E2|Reported Event|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
347588|NCT00763048|E1|Reported Event|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
347589|NCT00762996|B1|Baseline|Entire Population|
347590|NCT00762996|P4|Participant Flow|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
347591|NCT00762996|P3|Participant Flow|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
347592|NCT00762996|P2|Participant Flow|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
347593|NCT00762996|P1|Participant Flow|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
347594|NCT00762996|O2|Outcome|Omafilcon A|
347595|NCT00762996|O1|Outcome|Etafilcon A|
347596|NCT00762996|O2|Outcome|Omafilcon A|
347597|NCT00762996|O1|Outcome|Etafilcon A|
347598|NCT00762996|E4|Reported Event|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
347599|NCT00762996|E3|Reported Event|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
347600|NCT00762996|E2|Reported Event|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
347601|NCT00762996|E1|Reported Event|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
347602|NCT00762970|B4|Baseline|Total|Total of all reporting groups
347603|NCT00762970|B3|Baseline|Control Lens|Spectacle lenses worn daily.
347604|NCT00762970|B2|Baseline|Test Lens 2|Investigational soft contact lens worn daily.
347605|NCT00762970|B1|Baseline|Test Lens 1|Investigational soft contact lens worn daily.
347606|NCT00762970|P3|Participant Flow|Control Lens|Control spectacle lenses worn daily.
347607|NCT00762970|P2|Participant Flow|Test Lens 2|Investigational soft contact lenses worn daily.
347608|NCT00762970|P1|Participant Flow|Test Lens 1|Investigational soft contact lenses worn daily.
347609|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
347610|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
347611|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
347612|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
347613|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
347614|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
347615|NCT00762970|E3|Reported Event|Control Lens|Control spectacle lenses worn daily.
347616|NCT00762970|E2|Reported Event|Test Lens 2|Investigational soft contact lenses worn daily.
347617|NCT00762970|E1|Reported Event|Test Lens 1|Investigational soft contact lenses worn daily.
347618|NCT00762892|B3|Baseline|Total|Total of all reporting groups
347619|NCT00762892|B2|Baseline|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347620|NCT00762892|B1|Baseline|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347621|NCT00762892|P2|Participant Flow|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347622|NCT00762892|P1|Participant Flow|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347623|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347624|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347681|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347682|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
347625|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347626|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347627|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347628|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347629|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347630|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347631|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347632|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347633|NCT00762892|E2|Reported Event|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
347634|NCT00762892|E1|Reported Event|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
347635|NCT00762853|B3|Baseline|Total|Total of all reporting groups
347636|NCT00762853|B2|Baseline|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
347637|NCT00762853|B1|Baseline|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
347638|NCT00762853|P2|Participant Flow|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
347639|NCT00762853|P1|Participant Flow|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
347640|NCT00762853|O2|Outcome|Active Toothpaste|fluoride/triclosan/copolymer(Active) toothpaste
347641|NCT00762853|O1|Outcome|Fluoride Toothpaste (Placebo)|fluoride only toothpaste
347642|NCT00762853|E2|Reported Event|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
347643|NCT00762853|E1|Reported Event|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
347644|NCT00762788|B7|Baseline|Total|Total of all reporting groups
347645|NCT00762788|B6|Baseline|Etafilcon A Contact Lens|ACUVUE 2
347646|NCT00762788|B5|Baseline|Comfilcon A Contact Lens|Biofinity
347647|NCT00762788|B4|Baseline|Balafilcon A Contact Lens|PureVision
347648|NCT00762788|B3|Baseline|Lotrafilcon B Contact Lens|O2Optix
347649|NCT00762788|B2|Baseline|Lotrafilcon A Contact Lens|NIGHT&DAY
347650|NCT00762788|B1|Baseline|Senofilcon A Contact Lens|ACUVUE OASYS
347651|NCT00762788|P6|Participant Flow|Etafilcon A Contact Lens|ACUVUE 2
347652|NCT00762788|P5|Participant Flow|Comfilcon A Contact Lens|Biofinity
347653|NCT00762788|P4|Participant Flow|Balafilcon A Contact Lens|PureVision
347654|NCT00762788|P3|Participant Flow|Lotrafilcon B Contact Lens|O2Optix
347655|NCT00762788|P2|Participant Flow|Lotrafilcon A Contact Lens|NIGHT&DAY
347656|NCT00762788|P1|Participant Flow|Senofilcon A Contact Lens|ACUVUE OASYS
347657|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
347658|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
347659|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
347660|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
347661|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
347662|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
347663|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
347664|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
347665|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
347666|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
347667|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
347668|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
347669|NCT00762788|E6|Reported Event|Etafilcon A Contact Lens|ACUVUE 2
347670|NCT00762788|E5|Reported Event|Comfilcon A Contact Lens|Biofinity
347671|NCT00762788|E4|Reported Event|Balafilcon A Contact Lens|PureVision
347672|NCT00762788|E3|Reported Event|Lotrafilcon B Contact Lens|O2Optix
347673|NCT00762788|E2|Reported Event|Lotrafilcon A Contact Lens|NIGHT&DAY
347674|NCT00762788|E1|Reported Event|Senofilcon A Contact Lens|ACUVUE OASYS
347675|NCT00762762|B3|Baseline|Total|Total of all reporting groups
347676|NCT00762762|B2|Baseline|Placebo Comparator|Anti-cavity, fluoride oral rinse
347677|NCT00762762|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
347678|NCT00762762|P2|Participant Flow|Placebo Comparator|Anti-cavity, fluoride oral rinse
347679|NCT00762762|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
347687|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347688|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
347689|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
347690|NCT00762762|E2|Reported Event|Placebo Comparator|Anti-cavity, fluoride oral rinse
347691|NCT00762762|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
347692|NCT00762723|B4|Baseline|Total|Total of all reporting groups
347693|NCT00762723|B3|Baseline|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347694|NCT00762723|B2|Baseline|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347695|NCT00762723|B1|Baseline|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347696|NCT00762723|P3|Participant Flow|ALP With Hybrid Screws|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347697|NCT00762723|P2|Participant Flow|ALP With Variable Screws|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347698|NCT00762723|P1|Participant Flow|ALP With Fixed Screws|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347699|NCT00762723|O3|Outcome|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347700|NCT00762723|O2|Outcome|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347701|NCT00762723|O1|Outcome|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347702|NCT00762723|E3|Reported Event|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347703|NCT00762723|E2|Reported Event|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347704|NCT00762723|E1|Reported Event|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
347705|NCT00762645|B3|Baseline|Total|Total of all reporting groups
347706|NCT00762645|B2|Baseline|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
347707|NCT00762645|B1|Baseline|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
347708|NCT00762645|P2|Participant Flow|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
347709|NCT00762645|P1|Participant Flow|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
347710|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
347711|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
347712|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
347713|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
347714|NCT00762645|E2|Reported Event|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
347715|NCT00762645|E1|Reported Event|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
347716|NCT00762619|B3|Baseline|Total|Total of all reporting groups
347717|NCT00762619|B2|Baseline|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347718|NCT00762619|B1|Baseline|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347719|NCT00762619|P2|Participant Flow|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347720|NCT00762619|P1|Participant Flow|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347721|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347722|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347723|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347724|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347725|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347726|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347727|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347728|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347729|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347730|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347731|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347732|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347733|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347734|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347735|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347736|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347737|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347738|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347739|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347740|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347741|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347742|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347743|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347744|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347745|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347746|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347747|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347748|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347749|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347750|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347751|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347752|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347753|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347754|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347755|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347756|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347757|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347758|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347759|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347760|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347761|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347762|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347763|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347764|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347765|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347766|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347767|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347768|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347769|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347770|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347771|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347772|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347773|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347774|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347775|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347776|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347777|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347778|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347779|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347780|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347781|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347782|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347783|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347784|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347785|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347786|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347787|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347788|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347789|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347790|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347791|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347792|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347793|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347794|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347795|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347796|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347797|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347798|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347799|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347800|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347801|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347802|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347803|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347804|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347805|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347806|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347807|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347808|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347809|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347810|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347811|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347812|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347813|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347814|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347815|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347816|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347817|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347818|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347819|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347820|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347821|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347822|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347823|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347824|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347825|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347826|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347827|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347828|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347829|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347830|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347831|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
347832|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
347833|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347834|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347835|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347836|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347837|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347838|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347839|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347840|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347841|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347842|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347843|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347844|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347845|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347846|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347847|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347848|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347849|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347850|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347851|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347852|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347853|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347854|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347855|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347856|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347857|NCT00762619|E2|Reported Event|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347858|NCT00762619|E1|Reported Event|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
347859|NCT00762606|B3|Baseline|Total|Total of all reporting groups
347860|NCT00762606|B2|Baseline|SICS|Small incision cataract surgery (SICS)
347861|NCT00762606|B1|Baseline|Phaco|cataract extraction surgery utilizing Phacoemulsification
347862|NCT00762606|P2|Participant Flow|SICS|Small incision cataract surgery (SICS)
347863|NCT00762606|P1|Participant Flow|Phaco|cataract extraction surgery utilizing Phacoemulsification
347864|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
347865|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
347866|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
347867|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
347868|NCT00762606|E2|Reported Event|SICS|Small incision cataract surgery (SICS)
347869|NCT00762606|E1|Reported Event|Phaco|cataract extraction surgery utilizing Phacoemulsification
347870|NCT00762528|B3|Baseline|Total|Total of all reporting groups
347871|NCT00762528|B2|Baseline|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347872|NCT00762528|B1|Baseline|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347873|NCT00762528|P2|Participant Flow|Fluoride Toothpaste|Sodium monofluorophosphate toothpaste
347874|NCT00762528|P1|Participant Flow|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347875|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347876|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347877|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347878|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347879|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347880|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347881|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347882|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347883|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347884|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347885|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347886|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347887|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347888|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347889|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347890|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347891|NCT00762528|E2|Reported Event|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
347892|NCT00762528|E1|Reported Event|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
347893|NCT00762515|B3|Baseline|Total|Total of all reporting groups
347894|NCT00762515|B2|Baseline|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
347895|NCT00762515|B1|Baseline|A -Placebo Comparator|Fluoride toothpaste
347896|NCT00762515|P2|Participant Flow|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
347897|NCT00762515|P1|Participant Flow|A -Placebo Comparator|Fluoride toothpaste
347898|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
347899|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
347900|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
347901|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
347902|NCT00762515|E2|Reported Event|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
347903|NCT00762515|E1|Reported Event|A -Placebo Comparator|Fluoride toothpaste
347904|NCT00762502|B4|Baseline|Total|Total of all reporting groups
347905|NCT00762502|B3|Baseline|Senofilcon A/Balafilcon A Contralaterally|senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
347906|NCT00762502|B2|Baseline|Balafilcon A Toric Bilaterally|balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
347907|NCT00762502|B1|Baseline|Senofilcon A Toric Bilaterally|senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
347908|NCT00762502|P3|Participant Flow|Senofilcon A Toric/Balafilcon A Toric Contralaterally|Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
347909|NCT00762502|P2|Participant Flow|Balafilcon A Bilaterally|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
347910|NCT00762502|P1|Participant Flow|Senofilcon A Bilaterally|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
347911|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347912|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347913|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347914|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347915|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347916|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347917|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347918|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
347919|NCT00762502|E2|Reported Event|Balafilcon A|balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
347920|NCT00762502|E1|Reported Event|Senofilcon A|senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
347921|NCT00762476|B3|Baseline|Total|Total of all reporting groups
347922|NCT00762476|B2|Baseline|3804-250A|Experimental AV Lotion
347923|NCT00762476|B1|Baseline|Placebo|Modified AV Lotion without active ingredients.
347924|NCT00762476|P2|Participant Flow|3804-250A|Experimental AV Lotion
347925|NCT00762476|P1|Participant Flow|Placebo|Modified AV Lotion without active ingredients.
347926|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
347927|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
347928|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
347929|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
347930|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
347931|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients
347932|NCT00762476|E2|Reported Event|3804-250A|Experimental AV Lotion
347933|NCT00762476|E1|Reported Event|Placebo|Modified AV Lotion without active ingredients.
347934|NCT00762463|B3|Baseline|Total|Total of all reporting groups
347935|NCT00762463|B2|Baseline|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347936|NCT00762463|B1|Baseline|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347937|NCT00762463|P4|Participant Flow|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347938|NCT00762463|P3|Participant Flow|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347939|NCT00762463|P2|Participant Flow|Diclofenac SR 75 mg|Diclofenac sustained release (SR) 75 mg tablet once daily
347940|NCT00762463|P1|Participant Flow|Celecoxib 200 mg|Celecoxib 200 milligram (mg) capsule once daily
347941|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347942|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347943|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347944|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347945|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347946|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347947|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347948|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347949|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347950|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347951|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347952|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347953|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347954|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347955|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347956|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347957|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347958|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347959|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347960|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347961|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347962|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347963|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347964|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347965|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347966|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347967|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347968|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347969|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347970|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347971|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347972|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347973|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347974|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347975|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347976|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347977|NCT00762463|O4|Outcome|Diclofenac 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
347978|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347979|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347980|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347981|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347982|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347983|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347984|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347985|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347986|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347987|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347988|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347989|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347990|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347991|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347992|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347993|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347994|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
347995|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347996|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347997|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
347998|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
347999|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348000|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348001|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348002|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348003|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348004|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348005|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348006|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348007|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348008|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348009|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348010|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348011|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348012|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348013|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
348014|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
348015|NCT00762463|E6|Reported Event|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348016|NCT00762463|E5|Reported Event|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
348017|NCT00762463|E4|Reported Event|Diclofenac SR 75 mg, Then Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12
348018|NCT00762463|E3|Reported Event|Celecoxib 200 mg, Then Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12
348019|NCT00762463|E2|Reported Event|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6
348020|NCT00762463|E1|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6
348021|NCT00762450|B4|Baseline|Total|Total of all reporting groups
348022|NCT00762450|B3|Baseline|Experimental First, Placebo Second and Positive Control Last|
348023|NCT00762450|B2|Baseline|Positive Control First, Experimental Second and Placebo Last|
348024|NCT00762450|B1|Baseline|Placebo First, Positive Control Second and Experimental Last|
348025|NCT00762450|P3|Participant Flow|Experimental 1st, Placebo 2nd and Active Comparator Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
348026|NCT00762450|P2|Participant Flow|Active Comparator 1st, Experimental 2nd and Placebo Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
348027|NCT00762450|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
348028|NCT00762450|O3|Outcome|Experimental Toothpaste|
348029|NCT00762450|O2|Outcome|Placebo - Silica Control|
348030|NCT00762450|O1|Outcome|Active Comparator|
348031|NCT00762450|E3|Reported Event|Experimental First, Placebo Second and Positive Control Last|
348032|NCT00762450|E2|Reported Event|Positive Control First, Experimental Second and Placebo Last|
348033|NCT00762450|E1|Reported Event|Placebo First, Positive Control Second and Experimental Last|
348034|NCT00762424|B3|Baseline|Total|Total of all reporting groups
348035|NCT00762424|B2|Baseline|Placebo|placebo: cornstarch
348036|NCT00762424|B1|Baseline|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
348037|NCT00762424|P2|Participant Flow|Placebo|placebo: cornstarch
348038|NCT00762424|P1|Participant Flow|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
348039|NCT00762424|O2|Outcome|Placebo|placebo: cornstarch
348040|NCT00762424|O1|Outcome|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
348041|NCT00762424|E2|Reported Event|Placebo|placebo: cornstarch
348042|NCT00762424|E1|Reported Event|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
348043|NCT00762411|B3|Baseline|Total|Total of all reporting groups
348044|NCT00762411|B2|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348045|NCT00762411|B1|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348358|NCT00762086|B2|Baseline|Control Group|Aspirin/Clopidegrol and Standard walking exercises
348046|NCT00762411|P2|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348047|NCT00762411|P1|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348048|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348049|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348050|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348051|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348052|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348053|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348054|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348055|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348056|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348057|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348058|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348059|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348060|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348061|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348062|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348063|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348064|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348065|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348066|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348067|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348068|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348069|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348070|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348071|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348072|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348073|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348074|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348075|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348147|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348076|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348077|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348078|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348079|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348080|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348081|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348082|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348083|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348084|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348085|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348086|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348087|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348088|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348089|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348090|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348091|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348092|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348093|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348094|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348095|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348096|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348097|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348098|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348099|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348100|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348101|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348102|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
348103|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348104|NCT00762411|E6|Reported Event|140 mg LY450139 - SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
348105|NCT00762411|E5|Reported Event|Placebo-Safety Follow Up Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
348106|NCT00762411|E4|Reported Event|140 mg LY450139- DO|After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
348107|NCT00762411|E3|Reported Event|Placebo- (Delayed Start Period [DO])|After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
348108|NCT00762411|E2|Reported Event|140 mg LY450139- NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
348109|NCT00762411|E1|Reported Event|Placebo- (Initial Treatment Period [NT])|Participants received placebo orally once daily for the first 76 weeks.
348110|NCT00762385|B1|Baseline|Completed Population|Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
348111|NCT00762385|P2|Participant Flow|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
348112|NCT00762385|P1|Participant Flow|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
348113|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or the second intervention period.
348114|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
348115|NCT00762385|O2|Outcome|Comfilcon A|
348116|NCT00762385|O1|Outcome|Galyfilcon A|
348117|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or second intervention period.
348118|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
348119|NCT00762385|E2|Reported Event|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
348120|NCT00762385|E1|Reported Event|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
348121|NCT00762359|B3|Baseline|Total|Total of all reporting groups
348122|NCT00762359|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348123|NCT00762359|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348124|NCT00762359|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348125|NCT00762359|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348126|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348127|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348128|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348129|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348130|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348131|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348132|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348133|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348134|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348135|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348136|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348137|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348138|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348139|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348140|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348141|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348142|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348143|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348144|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348145|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348146|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348148|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348149|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348150|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348151|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348152|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348153|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348154|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348155|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348156|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348157|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348158|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348159|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348160|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348161|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348162|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348163|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348164|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348165|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348166|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348167|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348168|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348169|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348170|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348171|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348172|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348173|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348174|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348175|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348176|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348177|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348178|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348179|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348180|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348181|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348182|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348183|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348184|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348185|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348186|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348187|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348188|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348189|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348190|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348191|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348192|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348193|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348194|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348195|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348196|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348197|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348198|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348199|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348200|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348201|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348202|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348203|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348204|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348205|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348206|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348207|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348208|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348209|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348210|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348211|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348212|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348213|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348214|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348215|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348216|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348217|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348218|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348219|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348220|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348221|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348222|NCT00762359|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
348223|NCT00762359|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
348224|NCT00762320|B1|Baseline|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
348225|NCT00762320|P1|Participant Flow|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
348226|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4|Patients Receiving Low Dose Kaletra at Week 4
348227|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline|Patients receiving Low Dose Kaletra at baseline
348228|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348229|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348230|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348231|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra
348232|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4 Visit|Patient Satisfaction Score at Week 4 visit
348233|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline Visit|Patient satisfaction score at baseline visit
348234|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348235|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348236|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348237|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
348238|NCT00762320|E1|Reported Event|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
348239|NCT00762268|B3|Baseline|Total|Total of all reporting groups
348240|NCT00762268|B2|Baseline|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
348241|NCT00762268|B1|Baseline|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
348242|NCT00762268|P2|Participant Flow|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
348243|NCT00762268|P1|Participant Flow|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
348244|NCT00762268|O2|Outcome|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
348245|NCT00762268|O1|Outcome|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
348246|NCT00762268|E2|Reported Event|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
348247|NCT00762268|E1|Reported Event|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
348248|NCT00762229|B3|Baseline|Total|Total of all reporting groups
348249|NCT00762229|B2|Baseline|Ezetimibe 5 mg|Ezetimibe 5 mg,
348250|NCT00762229|B1|Baseline|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
348251|NCT00762229|P2|Participant Flow|Ezetimibe 5 mg|Ezetimibe 5 mg,
348252|NCT00762229|P1|Participant Flow|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
348253|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
348254|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
348255|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
348256|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
348257|NCT00762229|E2|Reported Event|Ezetimibe 5 mg|Ezetimibe 5 mg,
348258|NCT00762229|E1|Reported Event|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
348259|NCT00762216|B1|Baseline|Toric|Implantation with the AcrySof® Toric intraocular lens
348260|NCT00762216|P1|Participant Flow|Toric|Implantation with the AcrySof® Toric intraocular lens
348261|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
348262|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
348263|NCT00762216|E1|Reported Event|Toric|Implantation with the AcrySof® Toric intraocular lens
348264|NCT00762177|B4|Baseline|Total|Total of all reporting groups
348304|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348359|NCT00762086|B1|Baseline|Treatment Group|AngioPress IPC Device
348265|NCT00762177|B3|Baseline|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
348266|NCT00762177|B2|Baseline|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
348267|NCT00762177|B1|Baseline|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
348268|NCT00762177|P3|Participant Flow|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
348269|NCT00762177|P2|Participant Flow|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
348270|NCT00762177|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
348271|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348272|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348273|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348274|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348275|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348276|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348277|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348278|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348279|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348280|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348281|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348282|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348283|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348284|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348285|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348286|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348287|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348288|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348289|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348290|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348291|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348292|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348293|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348294|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348295|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348296|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348297|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348298|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348299|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348300|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348301|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348302|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348303|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348305|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348306|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348307|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348308|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348309|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348310|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348311|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348312|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348313|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348314|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348315|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348316|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348317|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348318|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348319|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348320|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348321|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348322|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348323|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348324|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348325|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348326|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348327|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348328|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348329|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348330|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348331|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348332|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348333|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348334|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348335|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348336|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348337|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348338|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
348339|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only)
348340|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
348341|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
348342|NCT00762177|O1|Outcome|Placebo Toothpaste|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
348343|NCT00762177|E3|Reported Event|Experimental|Experimental test product (stannous fluoride toothpaste)
348344|NCT00762177|E2|Reported Event|Active Comparator|Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total)
348345|NCT00762177|E1|Reported Event|Placebo - Fluoride Control|Fluoride only toothpaste (Crest Anti-Cavity)
348346|NCT00762164|B3|Baseline|Total|Total of all reporting groups
348347|NCT00762164|B2|Baseline|Simvastatin|Simvastatin 20 milligrams
348348|NCT00762164|B1|Baseline|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
348349|NCT00762164|P2|Participant Flow|Simvastatin|Simvastatin 20 milligrams
348350|NCT00762164|P1|Participant Flow|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
348351|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
348352|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
348353|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
348354|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
348355|NCT00762164|E2|Reported Event|Simvastatin|Simvastatin 20 milligrams
348356|NCT00762164|E1|Reported Event|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
348357|NCT00762086|B3|Baseline|Total|Total of all reporting groups
348360|NCT00762086|P2|Participant Flow|Control Group|Aspirin/Clopidegrol and Standard walking exercises
348361|NCT00762086|P1|Participant Flow|Treatment Group|AngioPress IPC Device
348362|NCT00762086|O2|Outcome|Control Group|Aspirin/Clopidegrol and Standard walking exercises
348363|NCT00762086|O1|Outcome|Treatment Group|AngioPress IPC Device
348364|NCT00762086|E2|Reported Event|Control Group|Aspirin/Clopidegrol and Standard walking exercises
348365|NCT00762086|E1|Reported Event|Treatment Group|AngioPress IPC Device
348366|NCT00762073|B5|Baseline|Total|Total of all reporting groups
348367|NCT00762073|B4|Baseline|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348368|NCT00762073|B3|Baseline|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348369|NCT00762073|B2|Baseline|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348370|NCT00762073|B1|Baseline|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348371|NCT00762073|P4|Participant Flow|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348372|NCT00762073|P3|Participant Flow|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348373|NCT00762073|P2|Participant Flow|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348374|NCT00762073|P1|Participant Flow|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348375|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348376|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348377|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348378|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348379|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348380|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348381|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348382|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348383|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
348384|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
348385|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
348386|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
348387|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
348388|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
348389|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
348390|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
348391|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
349107|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
348392|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
348393|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
348394|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
348395|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348396|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348397|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348398|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348399|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348400|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348401|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348402|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348403|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348404|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348405|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348406|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348407|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348408|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348409|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348410|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348411|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348412|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348413|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348414|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348415|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348416|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348417|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348418|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348419|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
349108|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
348420|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348421|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348422|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348423|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348424|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348425|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348426|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348427|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
348428|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
348429|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
348430|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
348431|NCT00762073|E4|Reported Event|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348432|NCT00762073|E3|Reported Event|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348433|NCT00762073|E2|Reported Event|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348434|NCT00762073|E1|Reported Event|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
348435|NCT00762034|B3|Baseline|Total|Total of all reporting groups
348436|NCT00762034|B2|Baseline|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348437|NCT00762034|B1|Baseline|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348438|NCT00762034|P2|Participant Flow|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348439|NCT00762034|P1|Participant Flow|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348440|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348584|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (Male)|Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348441|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348442|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348443|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348444|NCT00762034|O2|Outcome|TTF-1 Negative (H Score = 0)|"Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
348445|NCT00762034|O1|Outcome|TTF-1 Positive (H Score > 0)|"Participants who were TTF-1 Positive (H score > 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
348446|NCT00762034|O1|Outcome|Pem or Pac Plus Carbo/Bev|"Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
348447|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348448|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348449|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348450|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348451|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348556|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
349170|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
348452|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348453|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348454|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348455|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348456|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348457|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348458|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348459|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348460|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348461|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348515|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348462|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348463|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348464|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348465|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348466|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348467|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348468|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348469|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348470|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348471|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348585|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (Female)|Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348472|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348473|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348474|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348475|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348476|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348477|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348478|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348479|NCT00762034|O4|Outcome|Pac/Carbo/Bev; Maintenance Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348480|NCT00762034|O3|Outcome|Pac/Carbo/Bev; Induction Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348481|NCT00762034|O2|Outcome|Pem/Carbo/Bev; Maintenance Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348557|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
349097|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
348482|NCT00762034|O1|Outcome|Pem/Carbo/Bev; Induction Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348483|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348484|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348485|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348486|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348487|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348488|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348489|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348490|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348491|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348516|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348492|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
348493|NCT00762034|E2|Reported Event|Pac/Carbo/Bev|"Induction:~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
348494|NCT00762034|E1|Reported Event|Pem/Carbo/Bev|"Induction:~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
348495|NCT00762021|B3|Baseline|Total|Total of all reporting groups
348496|NCT00762021|B2|Baseline|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348497|NCT00762021|B1|Baseline|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348498|NCT00762021|P2|Participant Flow|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348499|NCT00762021|P1|Participant Flow|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348500|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348501|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348502|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348503|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348504|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348505|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348506|NCT00762021|E2|Reported Event|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
348507|NCT00762021|E1|Reported Event|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
348508|NCT00761969|B3|Baseline|Total|Total of all reporting groups
348509|NCT00761969|B2|Baseline|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348510|NCT00761969|B1|Baseline|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348511|NCT00761969|P2|Participant Flow|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
348512|NCT00761969|P1|Participant Flow|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
348513|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348514|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348555|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348517|NCT00761969|E2|Reported Event|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348518|NCT00761969|E1|Reported Event|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
348519|NCT00761956|B3|Baseline|Total|Total of all reporting groups
348520|NCT00761956|B2|Baseline|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
348521|NCT00761956|B1|Baseline|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
348522|NCT00761956|P2|Participant Flow|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
348523|NCT00761956|P1|Participant Flow|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
348524|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
348525|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
348526|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
348527|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
348528|NCT00761956|E2|Reported Event|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
348529|NCT00761956|E1|Reported Event|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
348530|NCT00761930|B4|Baseline|Total|Total of all reporting groups
348531|NCT00761930|B3|Baseline|C - Experimental Toothpaste|fluoride/herbal toothpaste
348532|NCT00761930|B2|Baseline|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348533|NCT00761930|B1|Baseline|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348534|NCT00761930|P3|Participant Flow|C - Experimental Toothpaste|fluoride/herbal toothpaste
348535|NCT00761930|P2|Participant Flow|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348536|NCT00761930|P1|Participant Flow|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348537|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
348538|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348539|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348540|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
348541|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348542|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348543|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
348544|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348545|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348546|NCT00761930|E3|Reported Event|C - Experimental Toothpaste|fluoride/herbal toothpaste
348547|NCT00761930|E2|Reported Event|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
348548|NCT00761930|E1|Reported Event|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
348549|NCT00761865|B3|Baseline|Total|Total of all reporting groups
348550|NCT00761865|B2|Baseline|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348551|NCT00761865|B1|Baseline|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348552|NCT00761865|P2|Participant Flow|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348553|NCT00761865|P1|Participant Flow|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348554|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348558|NCT00761865|E2|Reported Event|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348559|NCT00761865|E1|Reported Event|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
348560|NCT00761761|B3|Baseline|Total|Total of all reporting groups
348561|NCT00761761|B2|Baseline|Placebo|"Placebo~Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week and will be continued for a total of 8 weeks."
348562|NCT00761761|B1|Baseline|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348563|NCT00761761|P2|Participant Flow|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348564|NCT00761761|P1|Participant Flow|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348565|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348566|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348567|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348568|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348569|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348570|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348571|NCT00761761|O2|Outcome|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348572|NCT00761761|O1|Outcome|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348573|NCT00761761|E2|Reported Event|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348574|NCT00761761|E1|Reported Event|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
348575|NCT00761748|B1|Baseline|Overall Study Population|Urostomy operated subjects
348576|NCT00761748|P2|Participant Flow|ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece|Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
348577|NCT00761748|P1|Participant Flow|Sensura Uro 2 Piece First, Then Convatec 2 Piece|Sensura is a newly developed two piece product for people with urostomies.
348578|NCT00761748|O2|Outcome|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
348579|NCT00761748|O1|Outcome|Sensura Uro 2 Piece|The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
348580|NCT00761748|E2|Reported Event|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
348581|NCT00761748|E1|Reported Event|Sensura Uro 2 Piece|SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
348582|NCT00761735|B1|Baseline|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348583|NCT00761735|P1|Participant Flow|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348639|NCT00761605|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
348586|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348587|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348588|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348589|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348590|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348591|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348592|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (All)|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348593|NCT00761735|E1|Reported Event|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
348594|NCT00761631|B5|Baseline|Total|Total of all reporting groups
348595|NCT00761631|B4|Baseline|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348596|NCT00761631|B3|Baseline|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348597|NCT00761631|B2|Baseline|13vPnC Group 2 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
348598|NCT00761631|B1|Baseline|13vPnC Group 1 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
348599|NCT00761631|P6|Participant Flow|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348600|NCT00761631|P5|Participant Flow|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348601|NCT00761631|P4|Participant Flow|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348602|NCT00761631|P3|Participant Flow|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348603|NCT00761631|P2|Participant Flow|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348604|NCT00761631|P1|Participant Flow|13vPnC Group 1 (Cohort 1)|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348605|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348606|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348607|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348608|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348609|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348610|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348744|NCT00761319|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
348745|NCT00761319|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
348611|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348612|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348613|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348614|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348615|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348616|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348617|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348618|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348619|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348620|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348621|NCT00761631|O2|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348622|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348623|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348624|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348625|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348626|NCT00761631|E12|Reported Event|6-Month Follow-up 13vPnC Group 4|6 -Month Follow-up Telephone Contact for participants in Group 4.
348627|NCT00761631|E11|Reported Event|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
348628|NCT00761631|E10|Reported Event|6-Month Follow-up 13vPnC Group 3|6-month follow-up telephone contact for participants in Group 3.
348629|NCT00761631|E9|Reported Event|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
348630|NCT00761631|E8|Reported Event|6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
348631|NCT00761631|E7|Reported Event|6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
348632|NCT00761631|E6|Reported Event|13vPnC Group 2 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348633|NCT00761631|E5|Reported Event|13vPnC Group 1 (Cohort 2) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348634|NCT00761631|E4|Reported Event|13vPnC Group 1 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
348635|NCT00761631|E3|Reported Event|13vPnC Group 2 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348636|NCT00761631|E2|Reported Event|13vPnC Group 1 (Cohort 1) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348637|NCT00761631|E1|Reported Event|13vPnC Group 1 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
348638|NCT00761605|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
348746|NCT00761319|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
348640|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348641|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348642|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348643|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348644|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348645|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348646|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348647|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348648|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348649|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348650|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348651|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348652|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348653|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348654|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348655|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
349171|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
348656|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348657|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348658|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348659|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348660|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348661|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348662|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
348663|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348664|NCT00761605|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
348665|NCT00761592|B3|Baseline|Total|Total of all reporting groups
348666|NCT00761592|B2|Baseline|Botulinum Toxin Type A 150kDa|
348667|NCT00761592|B1|Baseline|Botulinum Toxin Type A 900kDa|
348668|NCT00761592|P2|Participant Flow|Botulinum Toxin Type A 150kDa|
348669|NCT00761592|P1|Participant Flow|Botulinum Toxin Type A 900kDa|
348670|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
348671|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
348672|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
348673|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
348674|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
348675|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
348676|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
348677|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
348678|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
348679|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
348680|NCT00761592|E2|Reported Event|Botulinum Toxin Type A 150kDa|
348681|NCT00761592|E1|Reported Event|Botulinum Toxin Type A 900kDa|
348682|NCT00761579|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
348683|NCT00761579|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
348684|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348685|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348686|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348747|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
348748|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
348687|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348688|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348689|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348690|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348691|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348692|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348693|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348694|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348695|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348696|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348697|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348698|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348699|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348700|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348701|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348702|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348749|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
348750|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
348751|NCT00761319|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
348703|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348704|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348705|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348706|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348707|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348708|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348709|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348710|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348711|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
348712|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
348713|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
348714|NCT00761579|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
348715|NCT00761527|B1|Baseline|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348716|NCT00761527|P1|Participant Flow|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348717|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348752|NCT00761319|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
348753|NCT00761306|B1|Baseline|Vortioxetine 5 or 10 mg/Day|tablets; orally
348754|NCT00761306|P1|Participant Flow|Vortioxetine 5 or 10 mg/Day|tablets; orally
348755|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
348718|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348719|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348720|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348721|NCT00761527|E1|Reported Event|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
348722|NCT00761514|B1|Baseline|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
348723|NCT00761514|P1|Participant Flow|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
348724|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
348725|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
348726|NCT00761514|E1|Reported Event|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
348727|NCT00761462|B3|Baseline|Total|Total of all reporting groups
348728|NCT00761462|B2|Baseline|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
348729|NCT00761462|B1|Baseline|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
348730|NCT00761462|P2|Participant Flow|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
348731|NCT00761462|P1|Participant Flow|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
348732|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
348733|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
348734|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
348735|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
348736|NCT00761462|E2|Reported Event|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
348737|NCT00761462|E1|Reported Event|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
348738|NCT00761345|B1|Baseline|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
348739|NCT00761345|P1|Participant Flow|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
348740|NCT00761345|O1|Outcome|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
348741|NCT00761345|E1|Reported Event|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
348742|NCT00761319|B3|Baseline|Total|Total of all reporting groups
348743|NCT00761319|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
348763|NCT00761280|B2|Baseline|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348764|NCT00761280|B1|Baseline|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348765|NCT00761280|P2|Participant Flow|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348766|NCT00761280|P1|Participant Flow|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348767|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348768|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348769|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348770|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348771|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348772|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348773|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348774|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348775|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348776|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348777|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348778|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348779|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348780|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348781|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348782|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348783|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348784|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348785|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348786|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348787|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348788|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348789|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348790|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348791|NCT00761280|E2|Reported Event|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
348792|NCT00761280|E1|Reported Event|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
348793|NCT00761215|B4|Baseline|Total|Total of all reporting groups
348794|NCT00761215|B3|Baseline|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
348795|NCT00761215|B2|Baseline|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
348796|NCT00761215|B1|Baseline|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
348797|NCT00761215|P3|Participant Flow|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
348798|NCT00761215|P2|Participant Flow|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
348799|NCT00761215|P1|Participant Flow|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
348800|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
348801|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
348802|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
348803|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
348804|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
348805|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
348806|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
348807|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
348808|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
348809|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
348810|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
348811|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
348812|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
348813|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
348814|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
348815|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
348816|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
348817|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
348818|NCT00761215|E3|Reported Event|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
348819|NCT00761215|E2|Reported Event|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
348820|NCT00761215|E1|Reported Event|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
348821|NCT00761202|B3|Baseline|Total|Total of all reporting groups
348822|NCT00761202|B2|Baseline|Sodium Hyaluronate|
348823|NCT00761202|B1|Baseline|Carboxymethylcellulose and Glycerin|
348824|NCT00761202|P2|Participant Flow|Sodium Hyaluronate|
348825|NCT00761202|P1|Participant Flow|Carboxymethylcellulose and Glycerin|
348826|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348827|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348828|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348829|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348830|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348831|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348832|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348833|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348834|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348835|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348836|NCT00761202|O2|Outcome|Sodium Hyaluronate|
348837|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
348838|NCT00761202|E2|Reported Event|Sodium Hyaluronate|
348839|NCT00761202|E1|Reported Event|Carboxymethylcellulose and Glycerin|
348840|NCT00761189|B1|Baseline|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348841|NCT00761189|P1|Participant Flow|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348842|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348843|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348844|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348845|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348846|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348847|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
349172|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
348848|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348849|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348850|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348851|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348852|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348853|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348854|NCT00761189|E1|Reported Event|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
348855|NCT00761176|B3|Baseline|Total|Total of all reporting groups
348856|NCT00761176|B2|Baseline|Standard of Care|Standardized wound care is used
348857|NCT00761176|B1|Baseline|Active|The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
348858|NCT00761176|P2|Participant Flow|Active|Provant Therapy Device
348859|NCT00761176|P1|Participant Flow|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
348860|NCT00761176|O2|Outcome|Active Provant Device|"Active Device~The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device."
348861|NCT00761176|O1|Outcome|Standard of Care|Standard of Care will be utilized without the device.
348862|NCT00761176|E2|Reported Event|Active|Provant Therapy Device
348863|NCT00761176|E1|Reported Event|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
348864|NCT00761150|B4|Baseline|Total|Total of all reporting groups
348865|NCT00761150|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
348866|NCT00761150|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
348867|NCT00761150|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
348868|NCT00761150|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
348869|NCT00761150|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
348870|NCT00761150|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
348871|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
348872|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
348873|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
348874|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
348875|NCT00761150|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
348876|NCT00761150|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
348877|NCT00761150|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
348878|NCT00761137|B1|Baseline|All Study Participants|This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
348879|NCT00761137|P1|Participant Flow|All Participants|subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
348880|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
348881|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
348882|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
348883|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
348884|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
348885|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
348886|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
348887|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
348888|NCT00761137|E1|Reported Event|All Participants|subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
348889|NCT00760266|B3|Baseline|Total|Total of all reporting groups
348890|NCT00760266|B2|Baseline|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348891|NCT00760266|B1|Baseline|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348892|NCT00760266|P2|Participant Flow|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348893|NCT00760266|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348894|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348895|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348896|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348897|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348898|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348899|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348900|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348901|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348902|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348903|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348904|NCT00760266|E2|Reported Event|HCTZ|HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
348905|NCT00760266|E1|Reported Event|Aliskiren / HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks
348906|NCT00760214|B4|Baseline|Total|Total of all reporting groups
348907|NCT00760214|B3|Baseline|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348908|NCT00760214|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348909|NCT00760214|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348910|NCT00760214|P3|Participant Flow|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348911|NCT00760214|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348912|NCT00760214|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348913|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348914|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348915|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348916|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348917|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348918|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348919|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348920|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348921|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348922|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348923|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348924|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348925|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348926|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348927|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348928|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348929|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348930|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348931|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348932|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348933|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348934|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348935|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348936|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348937|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348938|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348939|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348940|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348941|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348942|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348943|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348944|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348945|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348946|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348947|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348948|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348949|NCT00760214|E3|Reported Event|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
348950|NCT00760214|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
348951|NCT00760214|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
348952|NCT00761007|B5|Baseline|Total|Total of all reporting groups
348953|NCT00761007|B4|Baseline|Placebo|oral tablet, once daily
348954|NCT00761007|B3|Baseline|Ibodutant 60 mg|oral tablet, once daily
348955|NCT00761007|B2|Baseline|Ibodutant 30 mg|oral tablet, once daily
348956|NCT00761007|B1|Baseline|Ibodutant 10 mg|oral tablet, once daily
348957|NCT00761007|P4|Participant Flow|Placebo|oral tablet, once daily
348958|NCT00761007|P3|Participant Flow|Ibodutant 60 mg|oral tablet, once daily
348959|NCT00761007|P2|Participant Flow|Ibodutant 30 mg|oral tablet, once daily
348960|NCT00761007|P1|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
348961|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
348962|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
348963|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
348964|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
348965|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
348966|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
348967|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
348968|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
348969|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
348970|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
348971|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
348972|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
348973|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
348974|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
348975|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
348976|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
348977|NCT00761007|E4|Reported Event|Placebo|oral tablet, once daily
348978|NCT00761007|E3|Reported Event|Ibodutant 60 mg|oral tablet, once daily
348979|NCT00761007|E2|Reported Event|Ibodutant 30 mg|oral tablet, once daily
348980|NCT00761007|E1|Reported Event|Ibodutant 10 mg|oral tablet, once daily
348981|NCT00760877|B3|Baseline|Total|Total of all reporting groups
348982|NCT00760877|B2|Baseline|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348983|NCT00760877|B1|Baseline|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
349098|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
348984|NCT00760877|P2|Participant Flow|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348985|NCT00760877|P1|Participant Flow|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348986|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348987|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348988|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348989|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348990|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348991|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348992|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348993|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348994|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348995|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
348996|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
348997|NCT00760877|E3|Reported Event|Imatinib Subset That Crossed Over to Nilotinib|Imatinib subset that crossed over to nilotinib
348998|NCT00760877|E2|Reported Event|Imatinib|Imatinib
348999|NCT00760877|E1|Reported Event|Nilotinib|Nilotinib
349000|NCT00760838|B3|Baseline|Total|Total of all reporting groups
349001|NCT00760838|B2|Baseline|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349002|NCT00760838|B1|Baseline|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349003|NCT00760838|P2|Participant Flow|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349004|NCT00760838|P1|Participant Flow|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349005|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349006|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349007|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349008|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349009|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349010|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349011|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349012|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349013|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349014|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349015|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349016|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349017|NCT00760838|E2|Reported Event|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
349018|NCT00760838|E1|Reported Event|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
349019|NCT00760747|B3|Baseline|Total|Total of all reporting groups
349020|NCT00760747|B2|Baseline|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349021|NCT00760747|B1|Baseline|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349022|NCT00760747|P2|Participant Flow|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349023|NCT00760747|P1|Participant Flow|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349024|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349025|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349026|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349027|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349028|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349029|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349030|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349031|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349032|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349033|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349034|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349035|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349036|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349037|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349038|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349039|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349040|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349041|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349042|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349043|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349044|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349045|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349046|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349047|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349048|NCT00760747|E2|Reported Event|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
349049|NCT00760747|E1|Reported Event|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
349050|NCT00760669|B1|Baseline|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349051|NCT00760669|P1|Participant Flow|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349052|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349099|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349100|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349101|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349102|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349103|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349053|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349054|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349055|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349056|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349057|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349058|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349059|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349060|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349104|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349105|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349106|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349061|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349062|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349063|NCT00760669|E1|Reported Event|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
349064|NCT00760617|B4|Baseline|Total|Total of all reporting groups
349065|NCT00760617|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349066|NCT00760617|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349067|NCT00760617|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349068|NCT00760617|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349069|NCT00760617|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349070|NCT00760617|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349071|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349072|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349073|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349074|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349075|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349076|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349077|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349078|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349079|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349080|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349081|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349082|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349083|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349084|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349085|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349086|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349087|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349088|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349089|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349090|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349091|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349092|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349093|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349094|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349095|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349096|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349109|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349110|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349111|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349112|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349113|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349114|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349115|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349116|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349117|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349118|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349119|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349120|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349121|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349122|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349123|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349124|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349125|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349126|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349127|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349128|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349129|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349130|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349131|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349132|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349133|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349134|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349135|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349136|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349137|NCT00760617|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
349138|NCT00760617|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
349139|NCT00760617|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
349140|NCT00760578|B5|Baseline|Total|Total of all reporting groups
349141|NCT00760578|B4|Baseline|Placebo|Microcrystaline cellulose once daily
349142|NCT00760578|B3|Baseline|Pioglitazone|Pioglitazone 45 mg once daily
349143|NCT00760578|B2|Baseline|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349144|NCT00760578|B1|Baseline|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349145|NCT00760578|P4|Participant Flow|Placebo|Microcrystaline cellulose once daily
349146|NCT00760578|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg once daily
349147|NCT00760578|P2|Participant Flow|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349148|NCT00760578|P1|Participant Flow|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349149|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
349150|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
349151|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349152|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349153|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
349154|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
349155|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349156|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349157|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
349158|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
349159|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349160|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349161|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
349162|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
349163|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349164|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349165|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
349166|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
349167|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
349168|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
349169|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
349173|NCT00760578|O4|Outcome|Placebo|Placebo (microcrystalline cellulose) taken once daily for 28 days
349174|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
349175|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
349176|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
349177|NCT00760578|E4|Reported Event|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
349178|NCT00760578|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg once daily
349179|NCT00760578|E2|Reported Event|Placebo|Microcrystaline cellulose once daily
349180|NCT00760578|E1|Reported Event|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
349181|NCT00760552|B3|Baseline|Total|Total of all reporting groups
349182|NCT00760552|B2|Baseline|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
349183|NCT00760552|B1|Baseline|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
349184|NCT00760552|P2|Participant Flow|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
349185|NCT00760552|P1|Participant Flow|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
349186|NCT00760552|O2|Outcome|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
349187|NCT00760552|O1|Outcome|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
349188|NCT00760552|E2|Reported Event|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
349189|NCT00760552|E1|Reported Event|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
349190|NCT00760526|B3|Baseline|Total|Total of all reporting groups
349191|NCT00760526|B2|Baseline|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349192|NCT00760526|B1|Baseline|Continuous Glucose Montoring|Treatment group
349193|NCT00760526|P2|Participant Flow|Standard Glucose Monitoring With Home Glucose Meter|Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
349194|NCT00760526|P1|Participant Flow|Continuous Glucose Montoring|Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
349195|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: CGM Satisfaction
349196|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Blood Glucose Monitoring System Rating Scale
349197|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Blood Glucose Monitoring System Rating Scale
349198|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: PAID
349199|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: PAID
349200|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Hypoglycemia Fear Survey
349201|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Hypoglycemia Fear Survey
349202|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349203|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349204|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349205|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349206|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349207|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349208|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349209|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349210|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349211|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349212|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349213|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349214|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349215|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
349216|NCT00760526|E2|Reported Event|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
349217|NCT00760526|E1|Reported Event|Continuous Glucose Montoring|Treatment group
349218|NCT00760487|B1|Baseline|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349219|NCT00760487|P1|Participant Flow|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349220|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349221|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349222|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349223|NCT00760487|E1|Reported Event|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
349224|NCT00760474|B1|Baseline|Entire Study Population|"Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:~Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.~Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58."
349225|NCT00760474|P2|Participant Flow|Placebo First, Then Pregabalin|Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.
349226|NCT00760474|P1|Participant Flow|Pregabalin First, Then Placebo|Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
349227|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
349228|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
349229|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349230|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349231|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349232|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349233|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349234|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349235|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349236|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349237|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349238|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349239|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349240|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349241|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349242|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349243|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349244|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349245|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349246|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349247|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349248|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349249|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349250|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349251|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349252|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349253|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349254|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349255|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349256|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349257|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349337|NCT00759915|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
349338|NCT00759902|B3|Baseline|Total|Total of all reporting groups
349258|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349259|NCT00760474|E2|Reported Event|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
349260|NCT00760474|E1|Reported Event|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
349261|NCT00760435|B3|Baseline|Total|Total of all reporting groups
349262|NCT00760435|B2|Baseline|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
349263|NCT00760435|B1|Baseline|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
349264|NCT00760435|P2|Participant Flow|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
349265|NCT00760435|P1|Participant Flow|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
349266|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
349267|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
349268|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
349269|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
349270|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
349271|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
349272|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
349273|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
349274|NCT00760435|E2|Reported Event|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
349275|NCT00760435|E1|Reported Event|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
349276|NCT00760383|B3|Baseline|Total|Total of all reporting groups
349277|NCT00760383|B2|Baseline|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349278|NCT00760383|B1|Baseline|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349279|NCT00760383|P2|Participant Flow|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349280|NCT00760383|P1|Participant Flow|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349281|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349282|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349283|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349284|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349285|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349286|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349339|NCT00759902|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349287|NCT00760383|E2|Reported Event|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
349288|NCT00760383|E1|Reported Event|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
349289|NCT00760084|B1|Baseline|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
349290|NCT00760084|P1|Participant Flow|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
349291|NCT00760084|O1|Outcome|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
349292|NCT00760084|E1|Reported Event|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
349293|NCT00759954|B3|Baseline|Total|Total of all reporting groups
349294|NCT00759954|B2|Baseline|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
349295|NCT00759954|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349296|NCT00759954|P2|Participant Flow|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
349297|NCT00759954|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349298|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
349299|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
349300|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
349301|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
349302|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
349303|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
349304|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
349305|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
349306|NCT00759954|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
349307|NCT00759954|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
349308|NCT00759941|B3|Baseline|Total|Total of all reporting groups
349309|NCT00759941|B2|Baseline|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349310|NCT00759941|B1|Baseline|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349311|NCT00759941|P2|Participant Flow|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349312|NCT00759941|P1|Participant Flow|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349313|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349314|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349315|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349316|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349317|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349318|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349319|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349320|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349321|NCT00759941|E2|Reported Event|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
349322|NCT00759941|E1|Reported Event|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
349323|NCT00759915|B3|Baseline|Total|Total of all reporting groups
349324|NCT00759915|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349325|NCT00759915|B1|Baseline|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
349326|NCT00759915|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349327|NCT00759915|P1|Participant Flow|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
349328|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
349329|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
349330|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
349331|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
349332|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
349333|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
349334|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
349335|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
349336|NCT00759915|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
349340|NCT00759902|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349341|NCT00759902|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349342|NCT00759902|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349343|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
349344|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
349345|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
349346|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
349347|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
349348|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
349349|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
349350|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
349351|NCT00759902|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
349352|NCT00759902|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
349353|NCT00759863|B3|Baseline|Total|Total of all reporting groups
349354|NCT00759863|B2|Baseline|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349355|NCT00759863|B1|Baseline|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349356|NCT00759863|P2|Participant Flow|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349357|NCT00759863|P1|Participant Flow|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349358|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349359|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349360|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349361|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349362|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349363|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349364|NCT00759863|E2|Reported Event|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
349365|NCT00759863|E1|Reported Event|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
349366|NCT00759811|B3|Baseline|Total|Total of all reporting groups
349367|NCT00759811|B2|Baseline|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
349368|NCT00759811|B1|Baseline|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
349369|NCT00759811|P2|Participant Flow|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
349370|NCT00759811|P1|Participant Flow|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
349371|NCT00759811|O2|Outcome|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
349372|NCT00759811|O1|Outcome|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
349373|NCT00759811|E2|Reported Event|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
349374|NCT00759811|E1|Reported Event|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
349375|NCT00759759|B3|Baseline|Total|Total of all reporting groups
349376|NCT00759759|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349377|NCT00759759|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349378|NCT00759759|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349379|NCT00759759|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349380|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
349381|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
349382|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
349383|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
349384|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
349385|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
349386|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
349387|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
349388|NCT00759759|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
349389|NCT00759759|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
349390|NCT00759681|B3|Baseline|Total|Total of all reporting groups
349391|NCT00759681|B2|Baseline|Investigational Device|Investigational Treatment: ArterX Surgical Sealant
349392|NCT00759681|B1|Baseline|Control|Control Treatment: Gelfoam and Thrombin
349393|NCT00759681|P2|Participant Flow|Investigational Device: ArterX Surgical Sealant|ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
349394|NCT00759681|P1|Participant Flow|Control: Gelfoam and Thrombin|Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.
349395|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
349396|NCT00759681|O1|Outcome|Control Treatment|Control Treatment with Gelfoam and Thrombin
349397|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
349398|NCT00759681|O1|Outcome|Control Treatment|Control Treatment: Gelfoam and Thrombin
349399|NCT00759681|E2|Reported Event|1. ArterX Surgical Sealant|ArterX Surgical Sealant
349400|NCT00759681|E1|Reported Event|2. Gelfoam and Thrombin|Gelfoam and Thrombin
349401|NCT00759668|B3|Baseline|Total|Total of all reporting groups
349402|NCT00759668|B2|Baseline|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349403|NCT00759668|B1|Baseline|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349404|NCT00759668|P2|Participant Flow|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349405|NCT00759668|P1|Participant Flow|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349406|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349407|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349408|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349409|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349410|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349411|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349412|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349413|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349414|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349415|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349416|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349417|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349418|NCT00759668|E2|Reported Event|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
349419|NCT00759668|E1|Reported Event|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
349420|NCT00759655|B1|Baseline|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349421|NCT00759655|P1|Participant Flow|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349422|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349423|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349424|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349425|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349426|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349427|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349428|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349429|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349430|NCT00759655|E1|Reported Event|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
349431|NCT00759603|B1|Baseline|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
349432|NCT00759603|P1|Participant Flow|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
349433|NCT00759603|O1|Outcome|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
349434|NCT00759603|E1|Reported Event|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
349435|NCT00759577|B1|Baseline|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
349841|NCT00758758|E7|Reported Event|Autograft 2 Levels With Plate|Autograft 2 levels with plate
349436|NCT00759577|P1|Participant Flow|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
349437|NCT00759577|O1|Outcome|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
349438|NCT00759577|E1|Reported Event|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
349439|NCT00759564|B6|Baseline|Total|Total of all reporting groups
349440|NCT00759564|B5|Baseline|CP-70,429 (200 mg) + PF-03709270: Severe Renal Function|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349441|NCT00759564|B4|Baseline|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349442|NCT00759564|B3|Baseline|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349443|NCT00759564|B2|Baseline|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349444|NCT00759564|B1|Baseline|CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349445|NCT00759564|P5|Participant Flow|CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349446|NCT00759564|P4|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349447|NCT00759564|P3|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349448|NCT00759564|P2|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349449|NCT00759564|P1|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Normal Renal Function|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
349450|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349451|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349452|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349453|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349454|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349455|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349456|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349457|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349458|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349459|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349460|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349461|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349462|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349463|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349464|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349465|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349466|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349467|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349468|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349469|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349470|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349471|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349472|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349473|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349474|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349475|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349476|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349477|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349478|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349479|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349480|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349481|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349482|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349483|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349484|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349485|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349486|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349487|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349488|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349489|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349490|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349491|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349492|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349493|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349494|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349495|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349496|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349497|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349498|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349499|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349500|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349501|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349502|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349503|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349504|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349505|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349506|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349507|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349508|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349509|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349510|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349511|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349512|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349513|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349635|NCT00759356|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
355636|NCT00741026|O2|Outcome|Olanzapine|
349514|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349515|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349516|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349517|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349518|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349519|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349520|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349521|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349522|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349523|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349524|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349525|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349526|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349527|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349528|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349529|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349530|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349531|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349532|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349533|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349534|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349535|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349536|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349537|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349538|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349539|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349540|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349541|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349542|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349543|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349544|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349545|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349546|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349547|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349548|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349549|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­03709270 1000 mg tablet in second intervention period.
349550|NCT00759564|O1|Outcome|PF­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349551|NCT00759564|O4|Outcome|PF­-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349552|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349553|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349554|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349555|NCT00759564|O4|Outcome|PF-­03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349556|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349557|NCT00759564|O2|Outcome|PF-­03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
349558|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
349559|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349560|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349561|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349562|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349563|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349564|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349565|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349566|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349567|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349568|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349569|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
355637|NCT00741026|O1|Outcome|Placebo|
349570|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349571|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349572|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349573|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349574|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349575|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349576|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349577|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349578|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349579|NCT00759564|E9|Reported Event|PF-03709270 (1000 mg): Severe Renal|Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
349580|NCT00759564|E8|Reported Event|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349581|NCT00759564|E7|Reported Event|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349582|NCT00759564|E6|Reported Event|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
349583|NCT00759564|E5|Reported Event|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349584|NCT00759564|E4|Reported Event|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
349585|NCT00759564|E3|Reported Event|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349586|NCT00759564|E2|Reported Event|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349587|NCT00759564|E1|Reported Event|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
349588|NCT00759525|B1|Baseline|All Study Participants|
349589|NCT00759525|P2|Participant Flow|Placebo First, Then Glycyrrhetinic Acid|Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
349590|NCT00759525|P1|Participant Flow|Glycyrrhetinic Acid First, Then Placebo|Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo
349591|NCT00759525|O2|Outcome|Placebo|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
349592|NCT00759525|O1|Outcome|Glycyrrhinitic Acid|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
349593|NCT00759525|E2|Reported Event|Placebo First, Then Glycyrrhetinic Acid|Healthy subjects without medical condition.
349594|NCT00759525|E1|Reported Event|Glycyrrhetinic Acid First, Then Placebo|Healthy subjects without medical condition.
349595|NCT00759473|B6|Baseline|Total|Total of all reporting groups
349596|NCT00759473|B5|Baseline|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
349597|NCT00759473|B4|Baseline|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
349839|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel with out plate
349598|NCT00759473|B3|Baseline|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349599|NCT00759473|B2|Baseline|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349600|NCT00759473|B1|Baseline|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349601|NCT00759473|P5|Participant Flow|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
349602|NCT00759473|P4|Participant Flow|DCS/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
349603|NCT00759473|P3|Participant Flow|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349604|NCT00759473|P2|Participant Flow|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349605|NCT00759473|P1|Participant Flow|DCS/DCS/DCS/ Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
349606|NCT00759473|O5|Outcome|Placebo Plus Cognitive Skills Training|Participants received a placebo at 2 cue extinction sessions and at the one-week follow-up session. Participants also received cognitive skills training.
349607|NCT00759473|O4|Outcome|DCS Plus Cognitive Skills Training|Participants received 50 mg of DCS at 2 cue extinction sessions and placebo at the one-week follow-up session. Participants also received cognitive skills training.
349608|NCT00759473|O3|Outcome|DCS/ Placebo/DCS|Participants received 50 mg of DCS at the 1st and 3rd cue exposure sessions, and placebo at the 2nd cue exposure session and the one-week follow-up session.
349609|NCT00759473|O2|Outcome|Placebo Only|Participants received a placebo at each of 3 cue exposure sessions and at the one-week follow-up session.
349610|NCT00759473|O1|Outcome|DCS Only|Participants received 50 mg of DCS at each of 3 cue exposure sessions and placebo at the one-week follow-up session.
349611|NCT00759473|E5|Reported Event|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session.
349612|NCT00759473|E4|Reported Event|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session.
349613|NCT00759473|E3|Reported Event|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.
349614|NCT00759473|E2|Reported Event|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.
349615|NCT00759473|E1|Reported Event|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.
349616|NCT00759395|B3|Baseline|Total|Total of all reporting groups
349617|NCT00759395|B2|Baseline|Placebo|Placebo BID, Tablet, Oral, Daily
349618|NCT00759395|B1|Baseline|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349619|NCT00759395|P2|Participant Flow|Placebo|Placebo BID, Tablet, Oral, Daily
349620|NCT00759395|P1|Participant Flow|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349621|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
349622|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349623|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
349624|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349625|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
349626|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349627|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
349628|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349629|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
349630|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349631|NCT00759395|E2|Reported Event|Placebo|Placebo BID, Tablet, Oral, Daily
349632|NCT00759395|E1|Reported Event|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
349633|NCT00759356|B3|Baseline|Total|Total of all reporting groups
349634|NCT00759356|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
355638|NCT00741026|O2|Outcome|Olanzapine|
349636|NCT00759356|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
349637|NCT00759356|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
349638|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
349639|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
349640|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
349641|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
349642|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
349643|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
349644|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
349645|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
349646|NCT00759356|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
349647|NCT00759356|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
349648|NCT00759330|B5|Baseline|Total|Total of all reporting groups
349649|NCT00759330|B4|Baseline|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349650|NCT00759330|B3|Baseline|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349651|NCT00759330|B2|Baseline|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349652|NCT00759330|B1|Baseline|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349653|NCT00759330|P4|Participant Flow|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349654|NCT00759330|P3|Participant Flow|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349655|NCT00759330|P2|Participant Flow|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349656|NCT00759330|P1|Participant Flow|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349657|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349658|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349659|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349660|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349661|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349662|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349663|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349664|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349665|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349666|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349667|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349668|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349669|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349840|NCT00758758|E8|Reported Event|Allograft 2 Levels With Plate|Allograft 2 levels with plate
349670|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349671|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349672|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349673|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349674|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349675|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349676|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349677|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349678|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349679|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349680|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349681|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349682|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349683|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349684|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349685|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349686|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349687|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349688|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349689|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349690|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349691|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349692|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349693|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349694|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349695|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349696|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349697|NCT00759330|E4|Reported Event|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349698|NCT00759330|E3|Reported Event|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
349699|NCT00759330|E2|Reported Event|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
349700|NCT00759330|E1|Reported Event|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
349701|NCT00759187|B4|Baseline|Total|Total of all reporting groups
349702|NCT00759187|B3|Baseline|Chlorhexidine Gluconate|
349703|NCT00759187|B2|Baseline|Fluoride/Triclosan|
349704|NCT00759187|B1|Baseline|Fluoride|
349705|NCT00759187|P3|Participant Flow|Chlorhexidine Gluconate|
349706|NCT00759187|P2|Participant Flow|Fluoride/Triclosan|
349707|NCT00759187|P1|Participant Flow|Fluoride|
349708|NCT00759187|O3|Outcome|Chlorhexidine Gluconate|
349709|NCT00759187|O2|Outcome|Fluoride/Triclosan|
349710|NCT00759187|O1|Outcome|Fluoride|
349711|NCT00759187|E3|Reported Event|Chlorhexidine Gluconate|
349712|NCT00759187|E2|Reported Event|Fluoride/Triclosan|
349713|NCT00759187|E1|Reported Event|Fluoride|
349714|NCT00759174|B3|Baseline|Total|Total of all reporting groups
349715|NCT00759174|B2|Baseline|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
349716|NCT00759174|B1|Baseline|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
349717|NCT00759174|P2|Participant Flow|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
349718|NCT00759174|P1|Participant Flow|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
349719|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 7 weeks preceding the case window.
349720|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the week preceding the symptom onset day.
349721|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
349722|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
349723|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
349724|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
349725|NCT00759174|E1|Reported Event|Potential NAION Cases|All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
349726|NCT00759148|B3|Baseline|Total|Total of all reporting groups
349727|NCT00759148|B2|Baseline|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
349728|NCT00759148|B1|Baseline|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
349729|NCT00759148|P2|Participant Flow|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
349730|NCT00759148|P1|Participant Flow|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
349731|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
349732|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
349733|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
349734|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
349735|NCT00759148|E2|Reported Event|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
349736|NCT00759148|E1|Reported Event|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
349737|NCT00759109|B3|Baseline|Total|Total of all reporting groups
349738|NCT00759109|B2|Baseline|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349739|NCT00759109|B1|Baseline|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349740|NCT00759109|P2|Participant Flow|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349741|NCT00759109|P1|Participant Flow|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349742|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349743|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349744|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349745|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349746|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349747|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349748|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349749|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349750|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349751|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349752|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349753|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349754|NCT00759109|E2|Reported Event|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
349755|NCT00759109|E1|Reported Event|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
349756|NCT00759096|B1|Baseline|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
349757|NCT00759096|P1|Participant Flow|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
349758|NCT00759096|O1|Outcome|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
349759|NCT00759096|E1|Reported Event|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
349760|NCT00759031|B3|Baseline|Total|Total of all reporting groups
349761|NCT00759031|B2|Baseline|Triclosan + Fluoride 1st, Then Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
349762|NCT00759031|B1|Baseline|Fluoride 1st, Then Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
349763|NCT00759031|P2|Participant Flow|Triclosan + Fluoride 1st, Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
349764|NCT00759031|P1|Participant Flow|Fluoride 1st, Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
349765|NCT00759031|O2|Outcome|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
349766|NCT00759031|O1|Outcome|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
349767|NCT00759031|E2|Reported Event|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
349768|NCT00759031|E1|Reported Event|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
349769|NCT00758836|B5|Baseline|Total|Total of all reporting groups
349770|NCT00758836|B4|Baseline|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349771|NCT00758836|B3|Baseline|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349772|NCT00758836|B2|Baseline|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349773|NCT00758836|B1|Baseline|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349774|NCT00758836|P4|Participant Flow|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349775|NCT00758836|P3|Participant Flow|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349776|NCT00758836|P2|Participant Flow|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349777|NCT00758836|P1|Participant Flow|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349778|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349779|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349780|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349781|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349782|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349783|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349784|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349785|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349786|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349787|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349788|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349789|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349790|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349791|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349792|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349793|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349794|NCT00758836|E4|Reported Event|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
349795|NCT00758836|E3|Reported Event|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
349796|NCT00758836|E2|Reported Event|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
349797|NCT00758836|E1|Reported Event|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
349798|NCT00758771|B3|Baseline|Total|Total of all reporting groups
349799|NCT00758771|B2|Baseline|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
349800|NCT00758771|B1|Baseline|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
349801|NCT00758771|P2|Participant Flow|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
349802|NCT00758771|P1|Participant Flow|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
349803|NCT00758771|O2|Outcome|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
349804|NCT00758771|O1|Outcome|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
349805|NCT00758771|E2|Reported Event|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
349806|NCT00758771|E1|Reported Event|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
349807|NCT00758758|B9|Baseline|Total|Total of all reporting groups
349808|NCT00758758|B8|Baseline|Allograft 2 Levels With Plate|Allograft 2 levels with plate
349809|NCT00758758|B7|Baseline|Autograft 2 Levels With Plate|Autograft 2 levels with plate
349810|NCT00758758|B6|Baseline|Allograft With Plate|Allograft with plate
349811|NCT00758758|B5|Baseline|Autograft With Plate|Autograft with plate
349812|NCT00758758|B4|Baseline|Autograft Only - Illiac Crest|Autograft only - Illiac crest
349813|NCT00758758|B3|Baseline|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
349814|NCT00758758|B2|Baseline|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
349815|NCT00758758|B1|Baseline|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
349816|NCT00758758|P8|Participant Flow|Autograft 2 Levels With Plate|Autograft 2 levels with plate
349817|NCT00758758|P7|Participant Flow|Allograft 2 Levels With Plate|Allograft 2 levels with plate
349818|NCT00758758|P6|Participant Flow|Allograft 1 Level With Plate|Allograft 1 level plated
349819|NCT00758758|P5|Participant Flow|Autograft 1 Level With Plate|Autograft 1 level plated
349820|NCT00758758|P4|Participant Flow|Autograft Only - Illiac Crest|Autograft only - illiac crest
349821|NCT00758758|P3|Participant Flow|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
349822|NCT00758758|P2|Participant Flow|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
349823|NCT00758758|P1|Participant Flow|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
349824|NCT00758758|O8|Outcome|Allograft With 2 Plates|2 Levels with plated Allograft
349825|NCT00758758|O7|Outcome|Autograft With 2 Plates|2 Levels with plated Autograft
349826|NCT00758758|O6|Outcome|Allograft With Plate|Plated Allograft
349827|NCT00758758|O5|Outcome|Autograft With Plate|Plated Autograft
349828|NCT00758758|O4|Outcome|Illiac Crest Autograft|Iliac Crest Autograft
349829|NCT00758758|O3|Outcome|2 Levels Hedrocel With Plate|2 Levels Plated Hedrocel
349830|NCT00758758|O2|Outcome|Hedrocel With Plate|Hedrocel with a plate
349831|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel without plate
349832|NCT00758758|O8|Outcome|2 Levels With Plated Allograft|2 Levels with plated Allograft
349833|NCT00758758|O7|Outcome|2 Levels Plated Autograft|2 Levels with plated Autograft
349834|NCT00758758|O6|Outcome|Plated Allograft|Plated Allograft
349835|NCT00758758|O5|Outcome|Plated Autograft|Plated Autograft
349836|NCT00758758|O4|Outcome|Illiac Crest Autograft - no Plate|Iliac Crest Autograft
349837|NCT00758758|O3|Outcome|Two Levels Plated Hedrocel|2 Levels Plated Hedrocel
349838|NCT00758758|O2|Outcome|One Level Hedrocel With Plate|Hedrocel with a plate
349842|NCT00758758|E6|Reported Event|Allograft With Plate|Allograft with plate
349843|NCT00758758|E5|Reported Event|Autograft With Plate|Autograft with plate
349844|NCT00758758|E4|Reported Event|Autograft Only - Illiac Crest|Autograft only - Illiac crest
349845|NCT00758758|E3|Reported Event|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
349846|NCT00758758|E2|Reported Event|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
349847|NCT00758758|E1|Reported Event|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
349848|NCT00758745|B3|Baseline|Total|Total of all reporting groups
349849|NCT00758745|B2|Baseline|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
349850|NCT00758745|B1|Baseline|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
349851|NCT00758745|P2|Participant Flow|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
349852|NCT00758745|P1|Participant Flow|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
349853|NCT00758745|O2|Outcome|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
349854|NCT00758745|O1|Outcome|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
349855|NCT00758745|E2|Reported Event|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
349856|NCT00758745|E1|Reported Event|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
349857|NCT00758706|B3|Baseline|Total|Total of all reporting groups
349858|NCT00758706|B2|Baseline|Placebo|Placebo to AZD1236 twice daily(bid)
349859|NCT00758706|B1|Baseline|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349860|NCT00758706|P2|Participant Flow|Placebo|Placebo to AZD1236 twice daily(bid)
349861|NCT00758706|P1|Participant Flow|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349862|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349863|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349864|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349865|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349866|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349867|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349868|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349869|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349870|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349871|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349872|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349873|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349874|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349875|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349876|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349877|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349878|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349879|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349880|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349881|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349882|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349883|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349884|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349885|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349886|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349887|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349888|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349889|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349890|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349891|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349892|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
349893|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349894|NCT00758706|E2|Reported Event|Placebo|Placebo to AZD1236 twice daily(bid)
349895|NCT00758706|E1|Reported Event|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
349896|NCT00758680|B1|Baseline|All Treated Participants|After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349897|NCT00758680|P10|Participant Flow|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
349898|NCT00758680|P9|Participant Flow|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349899|NCT00758680|P8|Participant Flow|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349900|NCT00758680|P7|Participant Flow|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349901|NCT00758680|P6|Participant Flow|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
350003|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
355639|NCT00741026|O1|Outcome|Placebo|
349902|NCT00758680|P5|Participant Flow|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349903|NCT00758680|P4|Participant Flow|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349904|NCT00758680|P3|Participant Flow|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349905|NCT00758680|P2|Participant Flow|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349906|NCT00758680|P1|Participant Flow|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349907|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
349908|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349909|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349910|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349911|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349912|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349913|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349914|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349915|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349916|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349917|NCT00758680|O8|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
349918|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349919|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349920|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349921|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349922|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349923|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349924|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349925|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
349926|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349927|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349928|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349929|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349930|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349931|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349932|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349933|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349934|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349935|NCT00758680|E10|Reported Event|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
349936|NCT00758680|E9|Reported Event|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349937|NCT00758680|E8|Reported Event|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
349938|NCT00758680|E7|Reported Event|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349939|NCT00758680|E6|Reported Event|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349940|NCT00758680|E5|Reported Event|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349941|NCT00758680|E4|Reported Event|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349942|NCT00758680|E3|Reported Event|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349943|NCT00758680|E2|Reported Event|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
349944|NCT00758680|E1|Reported Event|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
349945|NCT00758667|B3|Baseline|Total|Total of all reporting groups
349946|NCT00758667|B2|Baseline|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349947|NCT00758667|B1|Baseline|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349948|NCT00758667|P2|Participant Flow|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349949|NCT00758667|P1|Participant Flow|Standard|Standard procedure or capsulectomy for removal of capsule;
349950|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349951|NCT00758667|O1|Outcome|Standard|Standard procedure or capsulectomy for removal of capsule;
349952|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349953|NCT00758667|O1|Outcome|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349954|NCT00758667|E2|Reported Event|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
349955|NCT00758667|E1|Reported Event|Standard|Standard procedure or capsulectomy for removal of capsule;
349956|NCT00758602|B3|Baseline|Total|Total of all reporting groups
349957|NCT00758602|B2|Baseline|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349958|NCT00758602|B1|Baseline|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
350004|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350005|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
349959|NCT00758602|P2|Participant Flow|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349960|NCT00758602|P1|Participant Flow|Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349961|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349962|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349963|NCT00758602|O2|Outcome|MMFl, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349964|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349965|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349966|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349967|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349968|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349969|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349970|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349971|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
350006|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
355640|NCT00741026|O2|Outcome|Olanzapine|
349972|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349973|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349974|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349975|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349976|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349977|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349978|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349979|NCT00758602|E2|Reported Event|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349980|NCT00758602|E1|Reported Event|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
349981|NCT00758589|B5|Baseline|Total|Total of all reporting groups
349982|NCT00758589|B4|Baseline|Placebo|placebo oral tablet, twice daily
349983|NCT00758589|B3|Baseline|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
349984|NCT00758589|B2|Baseline|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
349985|NCT00758589|B1|Baseline|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
349986|NCT00758589|P4|Participant Flow|Placebo|placebo oral tablet, twice daily
349987|NCT00758589|P3|Participant Flow|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
349988|NCT00758589|P2|Participant Flow|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
349989|NCT00758589|P1|Participant Flow|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
349990|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
349991|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
349992|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
349993|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
349994|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
349995|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
349996|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
349997|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
349998|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
349999|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350000|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350001|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350002|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350007|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350008|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350009|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350010|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350011|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350012|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350013|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350014|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350015|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350016|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350017|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350018|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350019|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350020|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350021|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350022|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350023|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350024|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350025|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350026|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350027|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350028|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350029|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350030|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350031|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350032|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350033|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350034|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350035|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350036|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350037|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350038|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350039|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350040|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350041|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350042|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350043|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350044|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350045|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350046|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
350047|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350048|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350049|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350050|NCT00758589|E4|Reported Event|Placebo|placebo oral tablet, twice daily
350051|NCT00758589|E3|Reported Event|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
350052|NCT00758589|E2|Reported Event|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
350053|NCT00758589|E1|Reported Event|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
350054|NCT00758576|B1|Baseline|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350055|NCT00758576|P1|Participant Flow|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350056|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350057|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350058|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350059|NCT00758576|E1|Reported Event|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
350060|NCT00758563|B3|Baseline|Total|Total of all reporting groups
350061|NCT00758563|B2|Baseline|Triclosan|
350062|NCT00758563|B1|Baseline|Fluoride|
350063|NCT00758563|P2|Participant Flow|Triclosan|
350064|NCT00758563|P1|Participant Flow|Fluoride|
350065|NCT00758563|O2|Outcome|Triclosan|
350066|NCT00758563|O1|Outcome|Fluoride|
350067|NCT00758550|B3|Baseline|Total|Total of all reporting groups
350068|NCT00758550|B2|Baseline|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
350069|NCT00758550|B1|Baseline|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
350070|NCT00758550|P2|Participant Flow|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
350071|NCT00758550|P1|Participant Flow|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
350072|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
350073|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
350074|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
350075|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
350076|NCT00758550|E2|Reported Event|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
350077|NCT00758550|E1|Reported Event|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
350078|NCT00758498|B4|Baseline|Total|Total of all reporting groups
350079|NCT00758498|B3|Baseline|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350080|NCT00758498|B2|Baseline|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350081|NCT00758498|B1|Baseline|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350082|NCT00758498|P3|Participant Flow|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350083|NCT00758498|P2|Participant Flow|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350084|NCT00758498|P1|Participant Flow|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350085|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350086|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350087|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350088|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350089|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350090|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350091|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350092|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350093|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350094|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350095|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350096|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350097|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350098|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350099|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350100|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350101|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350102|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350103|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350104|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350105|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350106|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350107|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350174|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350108|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350109|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350110|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350111|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350112|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350113|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350114|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350115|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350116|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350117|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350118|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350119|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350120|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350121|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350122|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350123|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350124|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350125|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350126|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350127|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350128|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350129|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350130|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350131|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350132|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350133|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350134|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350135|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350136|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350137|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350138|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350139|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350140|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350141|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350142|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350143|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350144|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350145|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350146|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350147|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350148|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350149|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350150|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350151|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350152|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350153|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350154|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350155|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350156|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350157|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350158|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350159|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350160|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350161|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350162|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350163|NCT00758498|E3|Reported Event|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350164|NCT00758498|E2|Reported Event|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350165|NCT00758498|E1|Reported Event|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
350166|NCT00758485|B3|Baseline|Total|Total of all reporting groups
350167|NCT00758485|B2|Baseline|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
350168|NCT00758485|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
350169|NCT00758485|P2|Participant Flow|Placebo|Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350170|NCT00758485|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
350171|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350172|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350173|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350175|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350176|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
350177|NCT00758485|E2|Reported Event|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350178|NCT00758485|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
350179|NCT00758459|B3|Baseline|Total|Total of all reporting groups
350180|NCT00758459|B2|Baseline|Placebo|Placebo
350181|NCT00758459|B1|Baseline|AZD1236|AZD1236
350182|NCT00758459|P2|Participant Flow|Placebo|Placebo
350183|NCT00758459|P1|Participant Flow|AZD1236|AZD1236
350184|NCT00758459|O2|Outcome|Placebo|Placebo
350185|NCT00758459|O1|Outcome|AZD1236|AZD1236
350186|NCT00758459|O2|Outcome|Placebo|Placebo
350187|NCT00758459|O1|Outcome|AZD1236|AZD1236
350188|NCT00758459|O2|Outcome|Placebo|Placebo
350189|NCT00758459|O1|Outcome|AZD1236|AZD1236
350190|NCT00758459|O2|Outcome|Placebo|Placebo
350191|NCT00758459|O1|Outcome|AZD1236|AZD1236
350192|NCT00758459|O2|Outcome|Placebo|Placebo
350193|NCT00758459|O1|Outcome|AZD1236|AZD1236
350194|NCT00758459|O2|Outcome|Placebo|Placebo
350195|NCT00758459|O1|Outcome|AZD1236|AZD1236
350196|NCT00758459|O2|Outcome|Placebo|Placebo
350197|NCT00758459|O1|Outcome|AZD1236|AZD1236
350198|NCT00758459|O2|Outcome|Placebo|Placebo
350199|NCT00758459|O1|Outcome|AZD1236|AZD1236
350200|NCT00758459|O2|Outcome|Placebo|Placebo
350201|NCT00758459|O1|Outcome|AZD1236|AZD1236
350202|NCT00758459|O2|Outcome|Placebo|Placebo
350203|NCT00758459|O1|Outcome|AZD1236|AZD1236
350204|NCT00758459|O2|Outcome|Placebo|Placebo
350205|NCT00758459|O1|Outcome|AZD1236|AZD1236
350206|NCT00758459|O2|Outcome|Placebo|Placebo
350207|NCT00758459|O1|Outcome|AZD1236|AZD1236
350208|NCT00758459|O2|Outcome|Placebo|Placebo
350209|NCT00758459|O1|Outcome|AZD1236|AZD1236
350210|NCT00758459|O2|Outcome|Placebo|Placebo
350211|NCT00758459|O1|Outcome|AZD1236|AZD1236
350212|NCT00758459|E2|Reported Event|Placebo|Placebo
350213|NCT00758459|E1|Reported Event|AZD1236|AZD1236
350214|NCT00758420|B3|Baseline|Total|Total of all reporting groups
350215|NCT00758420|B2|Baseline|Polidocanol Injectable Foam, 1.0%|Polidocanol injectable foam 1%, up to 15 mL, one treatment session
350216|NCT00758420|B1|Baseline|Placebo|Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
350217|NCT00758420|P2|Participant Flow|Placebo|"Agitated saline~Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session"
350218|NCT00758420|P1|Participant Flow|Active Treatment|polidocanol injectiable foam 1%, up to 15 mL, one treatment session
350219|NCT00758420|O2|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
350220|NCT00758420|O1|Outcome|Placebo|agitated saline
350221|NCT00758420|E2|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
350222|NCT00758420|E1|Reported Event|Placebo|agitated saline
350223|NCT00758394|B5|Baseline|Total|Total of all reporting groups
350224|NCT00758394|B4|Baseline|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
350225|NCT00758394|B3|Baseline|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
350226|NCT00758394|B2|Baseline|Fluoride/Triclosan - B|Positive control comparator
350227|NCT00758394|B1|Baseline|Fluoride - A|Negative control
350228|NCT00758394|P4|Participant Flow|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
350229|NCT00758394|P3|Participant Flow|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
350230|NCT00758394|P2|Participant Flow|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
350231|NCT00758394|P1|Participant Flow|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
350232|NCT00758394|O4|Outcome|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
350233|NCT00758394|O3|Outcome|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
350234|NCT00758394|O2|Outcome|Fluoride/Triclosan - B|Positive control comparator
350235|NCT00758394|O1|Outcome|Fluoride - A|Negative control
350236|NCT00758394|E4|Reported Event|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
350237|NCT00758394|E3|Reported Event|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
350238|NCT00758394|E2|Reported Event|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
350239|NCT00758394|E1|Reported Event|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
350240|NCT00758342|B3|Baseline|Total|Total of all reporting groups
350241|NCT00758342|B2|Baseline|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
350242|NCT00758342|B1|Baseline|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
350243|NCT00758342|P2|Participant Flow|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
350244|NCT00758342|P1|Participant Flow|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
350245|NCT00758342|O2|Outcome|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
353769|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
350246|NCT00758342|O1|Outcome|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
350247|NCT00758342|E2|Reported Event|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
350248|NCT00758342|E1|Reported Event|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
350249|NCT00758290|B3|Baseline|Total|Total of all reporting groups
350250|NCT00758290|B2|Baseline|Triclosan/Fluoride|
350251|NCT00758290|B1|Baseline|Fluoride/Triclosan|
350252|NCT00758290|P2|Participant Flow|Triclosan/Fluoride|
350253|NCT00758290|P1|Participant Flow|Fluoride/Triclosan|
350254|NCT00758290|O2|Outcome|Triclosan/Fluoride|
350255|NCT00758290|O1|Outcome|Fluoride/Triclosan|
350256|NCT00758160|B1|Baseline|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350257|NCT00758160|P1|Participant Flow|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350258|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350259|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350260|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350261|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350262|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350263|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350264|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350265|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350266|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350267|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350268|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350269|NCT00758160|O1|Outcome|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350270|NCT00758160|E4|Reported Event|OROS MPH-Week 8|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350271|NCT00758160|E3|Reported Event|OROS MPH-Week 4|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350272|NCT00758160|E2|Reported Event|OROS MPH-Week 2|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350273|NCT00758160|E1|Reported Event|OROS MPH-Baseline|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
350274|NCT00758069|B4|Baseline|Total|Total of all reporting groups
350275|NCT00758069|B3|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
350276|NCT00758069|B2|Baseline|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
350277|NCT00758069|B1|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
350278|NCT00758069|P3|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
350279|NCT00758069|P2|Participant Flow|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
350280|NCT00758069|P1|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
350281|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
350282|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
350283|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
350284|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
355641|NCT00741026|O1|Outcome|Placebo|
350285|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
350286|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
350287|NCT00758069|E3|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
350288|NCT00758069|E2|Reported Event|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
350289|NCT00758069|E1|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
350290|NCT00758043|B5|Baseline|Total|Total of all reporting groups
350291|NCT00758043|B4|Baseline|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
350292|NCT00758043|B3|Baseline|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
350293|NCT00758043|B2|Baseline|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350294|NCT00758043|B1|Baseline|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350295|NCT00758043|P4|Participant Flow|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
350296|NCT00758043|P3|Participant Flow|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
350297|NCT00758043|P2|Participant Flow|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350298|NCT00758043|P1|Participant Flow|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350299|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
350300|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
350301|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350302|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350303|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
350304|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
350305|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350306|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350307|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
350308|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
350309|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350310|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350311|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
350312|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
350313|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350314|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
350315|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
350316|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
350317|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350318|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350319|NCT00758043|E4|Reported Event|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
350320|NCT00758043|E3|Reported Event|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
350321|NCT00758043|E2|Reported Event|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350322|NCT00758043|E1|Reported Event|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
350323|NCT00757848|B3|Baseline|Total|Total of all reporting groups
350324|NCT00757848|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
350325|NCT00757848|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350326|NCT00757848|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
350327|NCT00757848|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350328|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350329|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350330|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350331|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350332|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350333|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350334|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350335|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350336|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350337|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350338|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350339|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350340|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350341|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350342|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350343|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350344|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350345|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350346|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350347|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350348|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350349|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350350|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350351|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350352|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350353|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350354|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350355|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350356|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350357|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350358|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350359|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350360|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350361|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350362|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350363|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350364|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350365|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350366|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
350367|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350368|NCT00757848|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
350369|NCT00757848|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
350370|NCT00757822|B3|Baseline|Total|Total of all reporting groups
350371|NCT00757822|B2|Baseline|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350372|NCT00757822|B1|Baseline|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350373|NCT00757822|P2|Participant Flow|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol."
350374|NCT00757822|P1|Participant Flow|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery."
350375|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350376|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350377|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350378|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350671|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350379|NCT00757822|O2|Outcome|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350380|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350381|NCT00757822|O2|Outcome|Arm 2: Ondnasetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350382|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350383|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350384|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350385|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350386|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350387|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350388|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350389|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
350390|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
350391|NCT00757822|E2|Reported Event|Ondansetron-control Therapy|Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
350392|NCT00757822|E1|Reported Event|Dronabinol- Experimental Therapy|Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.
350393|NCT00757783|B3|Baseline|Total|Total of all reporting groups
350394|NCT00757783|B2|Baseline|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350395|NCT00757783|B1|Baseline|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350396|NCT00757783|P2|Participant Flow|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350397|NCT00757783|P1|Participant Flow|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350398|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350399|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350400|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350401|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350402|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350403|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350404|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350405|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350406|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350407|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350408|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350409|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350410|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350411|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350412|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350413|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350477|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350414|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350415|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350416|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350417|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350418|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350419|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350420|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350421|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350422|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350423|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350424|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350425|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350426|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350427|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350428|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350429|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350430|NCT00757783|E2|Reported Event|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
350431|NCT00757783|E1|Reported Event|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
350432|NCT00757705|B1|Baseline|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350433|NCT00757705|P1|Participant Flow|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350434|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350435|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350436|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350437|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350438|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350439|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350440|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350478|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350672|NCT00756977|O1|Outcome|BLI850|
355642|NCT00741026|O2|Outcome|Olanzapine|
350441|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350442|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350443|NCT00757705|E1|Reported Event|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
350444|NCT00757627|B1|Baseline|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
350445|NCT00757627|P1|Participant Flow|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
350446|NCT00757627|O1|Outcome|Etoricoxib 60 mg q.d.|
350447|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
350448|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
350449|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
350450|NCT00757627|O1|Outcome|Week 4 - EQ-5D|
350451|NCT00757627|O1|Outcome|Baseline - EQ-5D|
350452|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
350453|NCT00757627|O1|Outcome|Etoricoxib (Week 4)|Etoricoxib 60 mg q.d.
350454|NCT00757627|O1|Outcome|Etoricoxib (Baseline)|Etoricoxib 60 mg q.d.
350455|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
350456|NCT00757627|E1|Reported Event|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
350457|NCT00757601|B1|Baseline|All Participants|Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
350458|NCT00757601|P12|Participant Flow|140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
350459|NCT00757601|P11|Participant Flow|140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
350460|NCT00757601|P10|Participant Flow|Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
350461|NCT00757601|P9|Participant Flow|140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo|Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
350462|NCT00757601|P8|Participant Flow|60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
350463|NCT00757601|P7|Participant Flow|60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
350464|NCT00757601|P6|Participant Flow|Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
350465|NCT00757601|P5|Participant Flow|60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo|Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
350466|NCT00757601|P4|Participant Flow|15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
350467|NCT00757601|P3|Participant Flow|15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
350468|NCT00757601|P2|Participant Flow|Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)|Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
350469|NCT00757601|P1|Participant Flow|15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)|Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
350470|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350471|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350472|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350473|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350474|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350475|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350476|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
354208|NCT00746733|E4|Reported Event|Adderall XR + Prilosec OTC|
350479|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350480|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350481|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350482|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350483|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
350484|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350485|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350486|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350487|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350488|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350489|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350490|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350491|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350492|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350493|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350494|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350495|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350496|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350497|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350498|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350499|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350500|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350501|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350502|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350503|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350504|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350505|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350506|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350507|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350508|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350509|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350510|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350511|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350512|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350513|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350514|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350515|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350516|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350517|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350518|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350519|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350520|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350521|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350522|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350523|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350524|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350525|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350526|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350527|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350528|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350529|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350530|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350531|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350532|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350533|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350534|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350535|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350536|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350537|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350538|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350539|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350540|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350541|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350542|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350543|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350544|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350545|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350546|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350547|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350548|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350549|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
350550|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350551|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350552|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350553|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350554|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350555|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350556|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350557|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350558|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350559|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350560|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350561|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350562|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350563|NCT00757601|E14|Reported Event|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
350564|NCT00757601|E13|Reported Event|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
350565|NCT00757601|E12|Reported Event|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
350566|NCT00757601|E11|Reported Event|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
350567|NCT00757601|E10|Reported Event|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
350568|NCT00757601|E9|Reported Event|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
350569|NCT00757601|E8|Reported Event|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
350570|NCT00757601|E7|Reported Event|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
350571|NCT00757601|E6|Reported Event|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
350572|NCT00757601|E5|Reported Event|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
350573|NCT00757601|E4|Reported Event|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
350574|NCT00757601|E3|Reported Event|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
350575|NCT00757601|E2|Reported Event|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
350576|NCT00757601|E1|Reported Event|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
350577|NCT00757588|B3|Baseline|Total|Total of all reporting groups
350578|NCT00757588|B2|Baseline|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350579|NCT00757588|B1|Baseline|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350580|NCT00757588|P2|Participant Flow|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350581|NCT00757588|P1|Participant Flow|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350582|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350583|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350584|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350585|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350586|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350587|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350588|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350589|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350590|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350591|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350592|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350593|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350594|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350595|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350596|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350597|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350598|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350599|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350600|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350601|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350602|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350669|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350670|NCT00756977|O1|Outcome|BLI850|
350603|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350604|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350605|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350606|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350607|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350608|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350609|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350610|NCT00757588|E2|Reported Event|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
350611|NCT00757588|E1|Reported Event|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
350612|NCT00757484|B1|Baseline|Women Who Underwent Gyneologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
350613|NCT00757484|P1|Participant Flow|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
350614|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
350615|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
350616|NCT00757484|O1|Outcome|Women Who Underwent GYN Surgery|All women who underwent inpatient GYN surgery between Jan 2007 and 2008.
350617|NCT00757484|O1|Outcome|Women Who Underwent Scheduled Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
350618|NCT00757484|E1|Reported Event|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient gynecologic surgery between Jan 2007 and 2008.
350619|NCT00757237|B3|Baseline|Total|Total of all reporting groups
350620|NCT00757237|B2|Baseline|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350621|NCT00757237|B1|Baseline|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350622|NCT00757237|P2|Participant Flow|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350623|NCT00757237|P1|Participant Flow|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350624|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350625|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350626|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350627|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350628|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350629|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350630|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350631|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350632|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350633|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350634|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350635|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350636|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350637|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350638|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350639|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350640|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350641|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350642|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350643|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350644|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350645|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350646|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350647|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350648|NCT00757237|E2|Reported Event|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
350649|NCT00757237|E1|Reported Event|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
350650|NCT00757172|B1|Baseline|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350651|NCT00757172|P1|Participant Flow|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350652|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350653|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350654|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350655|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350656|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350657|NCT00757172|E1|Reported Event|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
350658|NCT00756977|B3|Baseline|Total|Total of all reporting groups
350659|NCT00756977|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
350660|NCT00756977|B1|Baseline|BLI850|
350661|NCT00756977|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Single administration oral preparation
350662|NCT00756977|P1|Participant Flow|BLI850|Single administration oral preparation
350663|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350664|NCT00756977|O1|Outcome|BLI850|
350665|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350666|NCT00756977|O1|Outcome|BLI850|
350667|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350668|NCT00756977|O1|Outcome|BLI850|
350673|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350674|NCT00756977|O1|Outcome|BLI850|
350675|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350676|NCT00756977|O1|Outcome|BLI850|
350677|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350678|NCT00756977|O1|Outcome|BLI850|
350679|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350680|NCT00756977|O1|Outcome|BLI850|
350681|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350682|NCT00756977|O1|Outcome|BLI850|
350683|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350684|NCT00756977|O1|Outcome|BLI850|
350685|NCT00756977|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
350686|NCT00756977|E1|Reported Event|BLI850|
350687|NCT00756964|B3|Baseline|Total|Total of all reporting groups
350688|NCT00756964|B2|Baseline|Placebo Group|This group received an identical placebo of rasburicase.
350689|NCT00756964|B1|Baseline|Rasburicase Group|The drug rasburicase was used in this group.
350690|NCT00756964|P2|Participant Flow|Placebo Group|This group received an identical placebo of rasburicase.
350691|NCT00756964|P1|Participant Flow|Rasburicase Group|The drug rasburicase was used in this group.
350692|NCT00756964|O2|Outcome|Placebo Group|The patients which received a placebo identical to rasburicase.
350693|NCT00756964|O1|Outcome|Rasburicase Group|The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period
350694|NCT00756964|E2|Reported Event|Placebo Group|This group received an identical placebo of rasburicase.
350695|NCT00756964|E1|Reported Event|Rasburicase Group|The drug rasburicase was used in this group.
350696|NCT00756938|B4|Baseline|Total|Total of all reporting groups
350697|NCT00756938|B3|Baseline|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350698|NCT00756938|B2|Baseline|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
350699|NCT00756938|B1|Baseline|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350700|NCT00756938|P4|Participant Flow|Losartan Potassium-Extension|Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
350701|NCT00756938|P3|Participant Flow|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350702|NCT00756938|P2|Participant Flow|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
350703|NCT00756938|P1|Participant Flow|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350704|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
350705|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
350706|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
350707|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
350708|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
350709|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
350710|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
350711|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
350712|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
350713|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
350714|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350715|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
350716|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350717|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350718|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
350719|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
350720|NCT00756938|E8|Reported Event|Extension-Losartan 1.4 mg/kg/Day|
350721|NCT00756938|E7|Reported Event|Extension-Losartan 0.7 mg/kg/Day|
350722|NCT00756938|E6|Reported Event|Extension-Losartan 0.3 mg/kg/Day|
350723|NCT00756938|E5|Reported Event|Extension-Losartan 0.1 mg/kg/Day|
350724|NCT00756938|E4|Reported Event|Base Study-Losartan 1.4 mg/kg/Day|
350725|NCT00756938|E3|Reported Event|Base Study-Losartan Potassium 0.7 mg/kg/Day|
350726|NCT00756938|E2|Reported Event|Base Study-Losartan Potassium 0.3 mg/kg/Day|
350727|NCT00756938|E1|Reported Event|Base Study-Losartan Potassium 0.1 mg/kg/Day|
350728|NCT00756886|B3|Baseline|Total|Total of all reporting groups
350729|NCT00756886|B2|Baseline|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350730|NCT00756886|B1|Baseline|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350731|NCT00756886|P2|Participant Flow|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350732|NCT00756886|P1|Participant Flow|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350733|NCT00756886|O2|Outcome|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350734|NCT00756886|O1|Outcome|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350735|NCT00756886|E2|Reported Event|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350736|NCT00756886|E1|Reported Event|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
350737|NCT00756730|B3|Baseline|Total|Total of all reporting groups
350738|NCT00756730|B2|Baseline|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350739|NCT00756730|B1|Baseline|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350740|NCT00756730|P2|Participant Flow|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350741|NCT00756730|P1|Participant Flow|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350742|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350743|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350744|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350745|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350746|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350747|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350748|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350749|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350750|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350751|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350752|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350753|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350754|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350755|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350756|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350757|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350758|NCT00756730|E2|Reported Event|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
350759|NCT00756730|E1|Reported Event|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
350760|NCT00756678|B1|Baseline|All Patients|All patients
350761|NCT00756678|P1|Participant Flow|All Patients|All patients
350762|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
350763|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
350764|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
350765|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
355643|NCT00741026|O1|Outcome|Placebo|
350766|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
350767|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
350768|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
350769|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
350770|NCT00756678|E1|Reported Event|All Patients|All patients
350771|NCT00756574|B3|Baseline|Total|Total of all reporting groups
350772|NCT00756574|B2|Baseline|2. N95 Respirator|N95 respirator
350773|NCT00756574|B1|Baseline|1. Surgical|surgical mask
350774|NCT00756574|P2|Participant Flow|2. N95 Respirator|N95 respirator
350775|NCT00756574|P1|Participant Flow|1. Surgical|surgical mask
350776|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
350777|NCT00756574|O1|Outcome|1. Surgical|surgical mask
350778|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
350779|NCT00756574|O1|Outcome|1. Surgical|surgical mask
350780|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
350781|NCT00756574|O1|Outcome|1. Surgical|surgical mask
350782|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
350783|NCT00756574|O1|Outcome|1. Surgical|surgical mask
350784|NCT00756561|B1|Baseline|Healthy Normal Males|Men, 18-50 years of age, in good health
350785|NCT00756561|P1|Participant Flow|Healthy Normal Males|Men, 18-50 years of age, in good health
350786|NCT00756561|O2|Outcome|Serum Concentration|Serum hormone concentration in 10 normal men
350787|NCT00756561|O1|Outcome|Intratesticular Concentration|Average intratesticular hormone concentration between right and left testis in 10 normal men
350788|NCT00756561|E1|Reported Event|Healthy Normal Males|Men, 18-50 years of age, in good health
350789|NCT00756548|B3|Baseline|Total|Total of all reporting groups
350790|NCT00756548|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
350791|NCT00756548|B1|Baseline|BLI850|
350792|NCT00756548|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|single administration oral preparation - split dose
350793|NCT00756548|P1|Participant Flow|BLI850|single administration oral preparation - split dose
350794|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350795|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350796|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350797|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350798|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350799|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350800|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350801|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350802|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350803|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350804|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350805|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350806|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350807|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350808|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350809|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350810|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350811|NCT00756548|O1|Outcome|BLI850|
350812|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
350813|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
350814|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
350815|NCT00756548|O1|Outcome|BLI850|
350816|NCT00756548|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
350817|NCT00756548|E1|Reported Event|BLI850|
350818|NCT00756470|B1|Baseline|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
350819|NCT00756470|P1|Participant Flow|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
350843|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
351019|NCT00755846|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
354209|NCT00746733|E3|Reported Event|Vyvanse + Prilosec OTC|
350820|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
350821|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
350822|NCT00756470|E1|Reported Event|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
350823|NCT00756457|B3|Baseline|Total|Total of all reporting groups
350824|NCT00756457|B2|Baseline|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
350825|NCT00756457|B1|Baseline|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
350826|NCT00756457|P2|Participant Flow|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
350827|NCT00756457|P1|Participant Flow|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
350828|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350829|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
350830|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350831|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
350832|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350833|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
350834|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
350835|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
350836|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
350837|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
350838|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
350839|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
350840|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350841|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
350842|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350844|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
350845|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
350846|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
350847|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
350848|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
350849|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
350850|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
350851|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
350852|NCT00756457|E2|Reported Event|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
350853|NCT00756457|E1|Reported Event|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
350854|NCT00756444|B3|Baseline|Total|Total of all reporting groups
350855|NCT00756444|B2|Baseline|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350856|NCT00756444|B1|Baseline|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350857|NCT00756444|P2|Participant Flow|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350858|NCT00756444|P1|Participant Flow|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350859|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350860|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350861|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350862|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350863|NCT00756444|E3|Reported Event|Total|
350864|NCT00756444|E2|Reported Event|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350865|NCT00756444|E1|Reported Event|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
350866|NCT00756314|B3|Baseline|Total|Total of all reporting groups
350867|NCT00756314|B2|Baseline|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350868|NCT00756314|B1|Baseline|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350869|NCT00756314|P2|Participant Flow|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350870|NCT00756314|P1|Participant Flow|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350871|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350872|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350873|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350874|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350875|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350876|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350877|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350878|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350879|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350880|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350881|NCT00756314|E2|Reported Event|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
350882|NCT00756314|E1|Reported Event|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
350883|NCT00756093|B1|Baseline|Overall Study|
350884|NCT00756093|P4|Participant Flow|GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears|Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
350885|NCT00756093|P3|Participant Flow|Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive|Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
350886|NCT00756093|P2|Participant Flow|Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane|Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
350887|NCT00756093|P1|Participant Flow|Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate|Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
350888|NCT00756093|O4|Outcome|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
350889|NCT00756093|O3|Outcome|Blink Tears|Blink Tears
350890|NCT00756093|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
350891|NCT00756093|O1|Outcome|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
350892|NCT00756093|E4|Reported Event|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
350893|NCT00756093|E3|Reported Event|Blink Tears|Blink Tears
350894|NCT00756093|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
350895|NCT00756093|E1|Reported Event|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
350896|NCT00756002|B3|Baseline|Total|Total of all reporting groups
350897|NCT00756002|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350898|NCT00756002|B1|Baseline|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350899|NCT00756002|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350900|NCT00756002|P1|Participant Flow|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350901|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350902|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350903|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350904|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350905|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350906|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350907|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
351018|NCT00755846|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
350908|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350909|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350910|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350911|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350912|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350913|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350914|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350915|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350916|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350917|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350918|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350919|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350920|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350921|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350922|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350923|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350924|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350925|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350926|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350927|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350928|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350929|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350930|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350931|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350932|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350933|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350934|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350935|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350936|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350937|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350938|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350939|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350940|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350941|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350942|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350943|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350944|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350945|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350946|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350947|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350948|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350949|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350950|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350951|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350952|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350953|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350954|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350955|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350956|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350957|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350958|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350959|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350960|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350961|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350962|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350963|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350964|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350965|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350966|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350967|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350968|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350969|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350970|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350971|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350972|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350973|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350974|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350975|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350976|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350977|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350978|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350979|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350980|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350981|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350982|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350983|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350984|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350985|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350986|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350987|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350988|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350989|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350990|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350991|NCT00756002|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
350992|NCT00756002|E1|Reported Event|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
350993|NCT00755937|B1|Baseline|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350994|NCT00755937|P1|Participant Flow|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350995|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350996|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350997|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350998|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
350999|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
351000|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
351001|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
351002|NCT00755937|E1|Reported Event|Subjects Receiving Remicade|
351003|NCT00755911|B3|Baseline|Total|Total of all reporting groups
351004|NCT00755911|B2|Baseline|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
351005|NCT00755911|B1|Baseline|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
351006|NCT00755911|P2|Participant Flow|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
351007|NCT00755911|P1|Participant Flow|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
351008|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
351009|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
351010|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
351011|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
351012|NCT00755911|E2|Reported Event|Sham Comparator: Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
351013|NCT00755911|E1|Reported Event|Experimental: Tissue Repair Cell (TRC)|Subjects will receive TRC therapy plus Gelfoam carrier
351014|NCT00755846|B7|Baseline|Total|Total of all reporting groups
351015|NCT00755846|B6|Baseline|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351016|NCT00755846|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351017|NCT00755846|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351481|NCT00754546|E2|Reported Event|Cycle Exercise With the Active Comparator|
351020|NCT00755846|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351021|NCT00755846|P6|Participant Flow|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351022|NCT00755846|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351023|NCT00755846|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351024|NCT00755846|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351025|NCT00755846|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351026|NCT00755846|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351027|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351028|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351029|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351030|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351031|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351032|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351033|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351034|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351035|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351036|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351037|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351038|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351039|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351040|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351041|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351042|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351043|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351044|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351045|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351046|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351047|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351048|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351049|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351050|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351051|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351052|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351053|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351054|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351055|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351056|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351057|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351058|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351059|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351060|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351061|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351062|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351063|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351064|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351065|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351066|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351067|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351068|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351069|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351070|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351071|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351072|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351073|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351618|NCT00754325|B3|Baseline|Total|Total of all reporting groups
351074|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351075|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351076|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351077|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351078|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351079|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351080|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351081|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351082|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351083|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351084|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351085|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351086|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351087|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351088|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351089|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351090|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351091|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351092|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351093|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351094|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351095|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351096|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351097|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351098|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351099|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351100|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351101|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351102|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351103|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351104|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351105|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351106|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351107|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351108|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351109|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351110|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351111|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351112|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351113|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351114|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351115|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351116|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351117|NCT00755846|E6|Reported Event|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
351118|NCT00755846|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
351119|NCT00755846|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
351120|NCT00755846|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
351121|NCT00755846|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
351122|NCT00755846|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
351123|NCT00755807|B3|Baseline|Total|Total of all reporting groups
351124|NCT00755807|B2|Baseline|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351125|NCT00755807|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351126|NCT00755807|P2|Participant Flow|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351127|NCT00755807|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351128|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
351129|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
351130|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
351131|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351132|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351133|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351134|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351135|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
351136|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351137|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351138|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351139|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351140|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351141|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351142|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351143|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
351144|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351145|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351146|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351147|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351148|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351149|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351150|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351151|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351152|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351153|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351154|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351155|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351156|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351157|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351158|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351159|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351160|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351161|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351162|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351163|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351164|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351165|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351166|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351167|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351168|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351169|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351170|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351171|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351172|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351173|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351174|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351175|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351176|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
351177|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351178|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351179|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351180|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351181|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351182|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
351183|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
351184|NCT00755807|E3|Reported Event|Duloxetine - Open-label Extension Phase|Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
351185|NCT00755807|E2|Reported Event|Placebo - Double-Blind Acute Phase|Oral, QD for 6 weeks
351186|NCT00755807|E1|Reported Event|Duloxetine - Double-Blind Acute Phase|60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
351187|NCT00755755|B4|Baseline|Total|Total of all reporting groups
351188|NCT00755755|B3|Baseline|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351189|NCT00755755|B2|Baseline|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351190|NCT00755755|B1|Baseline|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351191|NCT00755755|P3|Participant Flow|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351192|NCT00755755|P2|Participant Flow|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351193|NCT00755755|P1|Participant Flow|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351194|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351195|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351196|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351197|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351198|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351199|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351200|NCT00755755|E3|Reported Event|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351201|NCT00755755|E2|Reported Event|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351202|NCT00755755|E1|Reported Event|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
351203|NCT00755417|B4|Baseline|Total|Total of all reporting groups
351204|NCT00755417|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
351205|NCT00755417|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351206|NCT00755417|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351207|NCT00755417|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
351208|NCT00755417|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351209|NCT00755417|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351210|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
351211|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351212|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351213|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
351214|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351215|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351216|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
351217|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351218|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351219|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
351220|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351221|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351222|NCT00755417|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
351223|NCT00755417|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
351224|NCT00755417|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
351225|NCT00755274|B3|Baseline|Total|Total of all reporting groups
351226|NCT00755274|B2|Baseline|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351227|NCT00755274|B1|Baseline|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351228|NCT00755274|P2|Participant Flow|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351229|NCT00755274|P1|Participant Flow|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351230|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351231|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351232|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351233|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351234|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351235|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351236|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351237|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351287|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
355644|NCT00741026|O2|Outcome|Olanzapine|
351238|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351239|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351240|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351241|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351242|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351243|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351244|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351245|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351246|NCT00755274|E2|Reported Event|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
351247|NCT00755274|E1|Reported Event|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
351248|NCT00755261|B1|Baseline|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
351249|NCT00755261|P1|Participant Flow|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
351250|NCT00755261|O1|Outcome|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
351251|NCT00755261|E1|Reported Event|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
351252|NCT00755235|B3|Baseline|Total|Total of all reporting groups
351253|NCT00755235|B2|Baseline|Usual Care|Participants will receive their usual care, with no additional education or care management services.
351254|NCT00755235|B1|Baseline|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
351255|NCT00755235|P2|Participant Flow|Usual Care|Participants will receive their usual care, with no additional education or care management services.
351256|NCT00755235|P1|Participant Flow|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
351257|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
351258|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
351259|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
351260|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
351261|NCT00755235|E2|Reported Event|Usual Care|Participants will receive their usual care, with no additional education or care management services.
351262|NCT00755235|E1|Reported Event|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
351263|NCT00755222|B3|Baseline|Total|Total of all reporting groups
351264|NCT00755222|B2|Baseline|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351265|NCT00755222|B1|Baseline|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351266|NCT00755222|P2|Participant Flow|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351267|NCT00755222|P1|Participant Flow|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351268|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351269|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351270|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351271|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351272|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351273|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351274|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351275|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351276|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351277|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351278|NCT00755222|E2|Reported Event|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351279|NCT00755222|E1|Reported Event|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
351280|NCT00755131|B3|Baseline|Total|Total of all reporting groups
351281|NCT00755131|B2|Baseline|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
351282|NCT00755131|B1|Baseline|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
351283|NCT00755131|P2|Participant Flow|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
351284|NCT00755131|P1|Participant Flow|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
351285|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
351286|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
354210|NCT00746733|E2|Reported Event|Adderall XR|
351288|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
351289|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
351290|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
351291|NCT00755131|E2|Reported Event|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
351292|NCT00755131|E1|Reported Event|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
351293|NCT00755105|B4|Baseline|Total|Total of all reporting groups
351294|NCT00755105|B3|Baseline|Postmenopausal Women Having Consumed Iron-55 Tracer|
351295|NCT00755105|B2|Baseline|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
351296|NCT00755105|B1|Baseline|Male Subjects Having Consumed Iron-55 Tracer|
351297|NCT00755105|P3|Participant Flow|Postmenopausal Women Having Consumed Iron-55 Tracer|
351298|NCT00755105|P2|Participant Flow|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
351299|NCT00755105|P1|Participant Flow|Male Subjects Having Consumed Iron-55 Tracer|
351300|NCT00755105|O3|Outcome|Postmenopausal Women Having Consumed Iron-55 Tracer|
351301|NCT00755105|O2|Outcome|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
351302|NCT00755105|O1|Outcome|Male Subjects Having Consumed Iron-55 Tracer|
351303|NCT00755105|E3|Reported Event|Postmenopausal Women Having Consumed Iron-55 Tracer|
351304|NCT00755105|E2|Reported Event|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
351305|NCT00755105|E1|Reported Event|Male Subjects Having Consumed Iron-55 Tracer|
351306|NCT00755079|B3|Baseline|Total|Total of all reporting groups
351307|NCT00755079|B2|Baseline|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
351308|NCT00755079|B1|Baseline|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
351309|NCT00755079|P2|Participant Flow|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
351310|NCT00755079|P1|Participant Flow|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
351311|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
351312|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
351313|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
351314|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
351315|NCT00755079|E2|Reported Event|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
351316|NCT00755079|E1|Reported Event|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
351317|NCT00755040|B3|Baseline|Total|Total of all reporting groups
351318|NCT00755040|B2|Baseline|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
351319|NCT00755040|B1|Baseline|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
351320|NCT00755040|P2|Participant Flow|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
351321|NCT00755040|P1|Participant Flow|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
351322|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
351323|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
351324|NCT00755040|E2|Reported Event|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
351325|NCT00755040|E1|Reported Event|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
351326|NCT00754923|B1|Baseline|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
355645|NCT00741026|O1|Outcome|Placebo|
351327|NCT00754923|P1|Participant Flow|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
351328|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
351329|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
351330|NCT00754923|E1|Reported Event|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
351331|NCT00754832|B1|Baseline|Intent to Treat Study Population|all participants who received at least one dose of either placebo or ginseng in this crossover trial
351332|NCT00754832|P2|Participant Flow|Placebo First Then Ginseng|placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
351333|NCT00754832|P1|Participant Flow|Ginseng First Then Placebo|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
351334|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
351335|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
351336|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
351337|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
351338|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
351339|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
351340|NCT00754832|E2|Reported Event|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
351341|NCT00754832|E1|Reported Event|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
351342|NCT00754793|B3|Baseline|Total|Total of all reporting groups
351343|NCT00754793|B2|Baseline|Placebo|Placebo drug
351344|NCT00754793|B1|Baseline|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
351345|NCT00754793|P2|Participant Flow|Placebo|Placebo drug
351346|NCT00754793|P1|Participant Flow|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
351347|NCT00754793|O2|Outcome|Placebo|Placebo drug
351348|NCT00754793|O1|Outcome|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
351349|NCT00754793|E2|Reported Event|Placebo|Placebo drug
351350|NCT00754793|E1|Reported Event|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
351351|NCT00754741|B4|Baseline|Total|Total of all reporting groups
351352|NCT00754741|B3|Baseline|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351353|NCT00754741|B2|Baseline|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351354|NCT00754741|B1|Baseline|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351355|NCT00754741|P3|Participant Flow|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351356|NCT00754741|P2|Participant Flow|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351357|NCT00754741|P1|Participant Flow|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351358|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351359|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351360|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351381|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351402|NCT00754741|E1|Reported Event|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351361|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351362|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351363|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351364|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351365|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351366|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351367|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351368|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351369|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351370|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351371|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351372|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351373|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351374|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351375|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351376|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351377|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351378|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351379|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351380|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351382|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351383|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351384|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351385|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351386|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351387|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351388|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351389|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351390|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351391|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351392|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351393|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351394|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351395|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351396|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351397|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351398|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351399|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
351400|NCT00754741|E3|Reported Event|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
351401|NCT00754741|E2|Reported Event|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
351403|NCT00754650|B1|Baseline|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
351404|NCT00754650|P1|Participant Flow|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
351405|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
351406|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
351407|NCT00754650|E1|Reported Event|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
351408|NCT00754624|B1|Baseline|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351409|NCT00754624|P1|Participant Flow|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351410|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351411|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351412|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351413|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351414|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351415|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351416|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351417|NCT00754624|E1|Reported Event|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
351418|NCT00754572|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351419|NCT00754572|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (iv), once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throuhgout the study.
351420|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351421|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351422|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351423|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351424|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351425|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351426|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351427|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351428|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351429|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351430|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351431|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351432|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351433|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351434|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351435|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351436|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
354211|NCT00746733|E1|Reported Event|Vyvanse|
351437|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351438|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351439|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351440|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351441|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351442|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351443|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351444|NCT00754572|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
351445|NCT00754559|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351446|NCT00754559|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks for a total of 6 infusions.
351447|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg /kg iv every 4 weeks for a total of 6 infusions.
351448|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351449|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351450|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351451|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351452|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351453|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351454|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351455|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351456|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351457|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351458|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351459|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351460|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351461|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351462|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
351463|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351464|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351465|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351466|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351467|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351468|NCT00754559|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
351469|NCT00754546|B1|Baseline|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
351470|NCT00754546|P1|Participant Flow|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
351471|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
351472|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
351473|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
351474|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
351475|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
351476|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
351477|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
351478|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
351479|NCT00754546|E4|Reported Event|Cycle Exercise With the Placebo Comparator|
351480|NCT00754546|E3|Reported Event|Treadmill Exercise With the Placebo Comparator|
351482|NCT00754546|E1|Reported Event|Treadmill Exercise With the Active Comparator|
351483|NCT00752791|B1|Baseline|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351484|NCT00752791|P1|Participant Flow|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351485|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351486|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351487|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351488|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351489|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351490|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351491|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351492|NCT00752791|E1|Reported Event|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
351493|NCT00754494|B4|Baseline|Total|Total of all reporting groups
351494|NCT00754494|B3|Baseline|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351495|NCT00754494|B2|Baseline|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351496|NCT00754494|B1|Baseline|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351497|NCT00754494|P3|Participant Flow|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351498|NCT00754494|P2|Participant Flow|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351499|NCT00754494|P1|Participant Flow|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351500|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351501|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351502|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351503|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351504|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351505|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351506|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351688|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351689|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351507|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351508|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351509|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351510|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351511|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351512|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351513|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351514|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351515|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351516|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351517|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351518|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351519|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351520|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351521|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351522|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351523|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351524|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351525|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351526|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351527|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351528|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351529|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351530|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351531|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
355646|NCT00741026|O2|Outcome|Olanzapine|
351532|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351533|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351534|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351535|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351536|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
351537|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
351538|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
351539|NCT00754494|E3|Reported Event|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351540|NCT00754494|E2|Reported Event|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351541|NCT00754494|E1|Reported Event|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
351542|NCT00754468|B3|Baseline|Total|Total of all reporting groups
351543|NCT00754468|B2|Baseline|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351544|NCT00754468|B1|Baseline|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351545|NCT00754468|P2|Participant Flow|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351546|NCT00754468|P1|Participant Flow|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351547|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds
351548|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment
351549|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 2 cycles x20 seconds~Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds"
351550|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds~Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment"
351690|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351691|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351551|NCT00754468|E2|Reported Event|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351552|NCT00754468|E1|Reported Event|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
351553|NCT00754442|B3|Baseline|Total|Total of all reporting groups
351554|NCT00754442|B2|Baseline|Patient Group|patients with secondary hyperparathyroidism
351555|NCT00754442|B1|Baseline|Controls|controls with normal PTH
351556|NCT00754442|P2|Participant Flow|Patient Group|patients with secondary hyperparathyroidism
351557|NCT00754442|P1|Participant Flow|Controls|controls with normal PTH
351558|NCT00754442|O1|Outcome|Patients|patients with idiopathic secondary hyperparathyroidism
351559|NCT00754442|O2|Outcome|Controls|Controls without secondary hyperparathyroidism
351560|NCT00754442|O1|Outcome|Group 1|"patients with secondary hyperparathyroidism"
351561|NCT00754442|E2|Reported Event|Patient Group|patients with secondary hyperparathyroidism
351562|NCT00754442|E1|Reported Event|Controls|controls with normal PTH
351563|NCT00754390|B1|Baseline|Entire Study Population|Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment
351564|NCT00754390|P1|Participant Flow|Calcium and Phytate Interactions|Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order
351565|NCT00754390|O4|Outcome|High Calcium, High Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
351566|NCT00754390|O3|Outcome|High Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
351567|NCT00754390|O2|Outcome|Moderate Calcium, High Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
351568|NCT00754390|O1|Outcome|Moderate Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
351569|NCT00754390|E1|Reported Event|Overall Study|Participants consumed 4 dietary treatments in randomized order
351570|NCT00754377|B3|Baseline|Total|Total of all reporting groups
351571|NCT00754377|B2|Baseline|Comparison Group|Didn't receive intervention
351572|NCT00754377|B1|Baseline|PBLI Curriculum Group|Received PBLI curriculum to evaluate and develop tools.
351573|NCT00754377|P2|Participant Flow|Comparison Group|Alternate rotations and didn't receive intervention
351574|NCT00754377|P1|Participant Flow|PBL Curriculum Group|"To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.~PBLI curriculum comparison: The design is a pre-post comparison of PBLI curriculum participants versus non-participants. Data will come from the closed-ended items on the questionnaire given before the rotation and at the end of the rotation. PBLI curriculum was offered on alternate rotations (residents on alternate month were involved with a different curriculum). Preliminary data is available from 11 blocks, 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42) during the previous academic year. Closed-ended items assessed beliefs about different aspects of Continuous Quality Improvement (CQI) project development and implementation (6 items). In addition, there were 5 short definition items to address knowledge. Finally, content analysis methods will be used to evaluate responses to the open-ended item which asked respondents to develop a project to improve patient care."
351575|NCT00754377|O2|Outcome|Comparison Group|Didn't receive the intervention.
351576|NCT00754377|O1|Outcome|PBLI Curriclum Group|Received the intervention and evaluate and develop PBLI tools
351577|NCT00754377|O2|Outcome|Comparison Group|Didn't receive intervention
351578|NCT00754377|O1|Outcome|PBLI Curriculum Group|Received the intervention and used to evaluate and develop PBLI tools
351579|NCT00754377|E2|Reported Event|Comparison Group|Didn't receive the intervention
351580|NCT00754377|E1|Reported Event|PBLI Curriculum Group|Received the intervention. To evaluate and develop PBLI tools.
351581|NCT00754338|B5|Baseline|Total|Total of all reporting groups
351582|NCT00754338|B4|Baseline|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351583|NCT00754338|B3|Baseline|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351584|NCT00754338|B2|Baseline|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351585|NCT00754338|B1|Baseline|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351682|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
351586|NCT00754338|P4|Participant Flow|Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
351587|NCT00754338|P3|Participant Flow|Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
351588|NCT00754338|P2|Participant Flow|Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
351589|NCT00754338|P1|Participant Flow|Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
351590|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351591|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351592|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351593|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351594|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351595|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351596|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351597|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351598|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351599|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351600|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351601|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351602|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351603|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351604|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351605|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351606|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351607|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351608|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351609|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351610|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351611|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351612|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
351613|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351614|NCT00754338|E4|Reported Event|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351615|NCT00754338|E3|Reported Event|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351616|NCT00754338|E2|Reported Event|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
351617|NCT00754338|E1|Reported Event|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
351619|NCT00754325|B2|Baseline|Fulvestrant|"Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351620|NCT00754325|B1|Baseline|Fulvestrant and Dasatinib|"Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351621|NCT00754325|P2|Participant Flow|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351622|NCT00754325|P1|Participant Flow|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351623|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351624|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351625|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351626|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351627|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351628|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351629|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351630|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351631|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351632|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351633|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351634|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351635|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351636|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351683|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351684|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351685|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351686|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
351687|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351637|NCT00754325|E3|Reported Event|Fulvestrant Crossover to Fulvestrant and Dasatinib|"Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351638|NCT00754325|E2|Reported Event|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
351639|NCT00754325|E1|Reported Event|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
351640|NCT00754234|B1|Baseline|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
351641|NCT00754234|P1|Participant Flow|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
351642|NCT00754234|O1|Outcome|MyPyramid Menu|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
351643|NCT00754234|E1|Reported Event|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
351644|NCT00754156|B3|Baseline|Total|Total of all reporting groups
351645|NCT00754156|B2|Baseline|V.A.C. or ABThera|V.A.C. or ABThera Therapy alone
351646|NCT00754156|B1|Baseline|1 ABRA Plus V.A.C or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy
351647|NCT00754156|P2|Participant Flow|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351648|NCT00754156|P1|Participant Flow|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351649|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351650|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351651|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351652|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351653|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351654|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351655|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351656|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351657|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|V.A.C. or ABThera V.A.C. Therapy alone
351658|NCT00754156|O1|Outcome|1 ABRA Plus V.A.C. or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy
351659|NCT00754156|O2|Outcome|2 ABThera|V.A.C. or ABThera V.A.C. Therapy alone
351660|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy
351661|NCT00754156|O2|Outcome|2 ABThera|ABThera V.A.C. Therapy alone
351662|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351663|NCT00754156|E2|Reported Event|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
351664|NCT00754156|E1|Reported Event|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
351665|NCT00754130|B7|Baseline|Total|Total of all reporting groups
351666|NCT00754130|B6|Baseline|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
351667|NCT00754130|B5|Baseline|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
351668|NCT00754130|B4|Baseline|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
351669|NCT00754130|B3|Baseline|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
351670|NCT00754130|B2|Baseline|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
351671|NCT00754130|B1|Baseline|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
351672|NCT00754130|P6|Participant Flow|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
351673|NCT00754130|P5|Participant Flow|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
351674|NCT00754130|P4|Participant Flow|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
351675|NCT00754130|P3|Participant Flow|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
351676|NCT00754130|P2|Participant Flow|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
351677|NCT00754130|P1|Participant Flow|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
351678|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351679|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351680|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351681|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351692|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351693|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351694|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351695|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351696|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351697|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351698|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351699|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351700|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351701|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351702|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351703|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
351704|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351705|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351706|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351707|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
351708|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351709|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351710|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351711|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
351712|NCT00754130|E5|Reported Event|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
351713|NCT00754130|E4|Reported Event|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
351714|NCT00754130|E3|Reported Event|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
351715|NCT00754130|E2|Reported Event|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
351716|NCT00754130|E1|Reported Event|Placebo|Participants receiving Placebo doses three times daily
351717|NCT00754065|B3|Baseline|Total|Total of all reporting groups
351718|NCT00754065|B2|Baseline|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351719|NCT00754065|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351720|NCT00754065|P2|Participant Flow|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351721|NCT00754065|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351722|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351723|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351724|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351725|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351726|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351727|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351728|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351729|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351730|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
355647|NCT00741026|O1|Outcome|Placebo|
351731|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351732|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351733|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351734|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351735|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351736|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351737|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351738|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351739|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351740|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351741|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351742|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351743|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351744|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351745|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351746|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351747|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351748|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351749|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351750|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351751|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351752|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351753|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351754|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352050|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
351755|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351756|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351757|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351758|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351759|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351760|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351761|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351762|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351763|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351764|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351765|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351766|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351767|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351768|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351769|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351770|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351771|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351772|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351773|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351774|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351775|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351776|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351777|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351778|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352051|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
351779|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351780|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351781|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351782|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351783|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351784|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351785|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351786|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351787|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351788|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351789|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351790|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351791|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351792|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351793|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351794|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351795|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351796|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351797|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351798|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351799|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351800|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351801|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351802|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352052|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
351803|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351804|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351805|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351806|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351807|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351808|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351809|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351810|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351811|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351812|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351813|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351814|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351815|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351816|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351817|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351818|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351819|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351820|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351821|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351822|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351823|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351824|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351825|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351826|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352053|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
351827|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351828|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351829|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351830|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351831|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351832|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351833|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351834|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351835|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351836|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351837|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351838|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351839|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351840|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351841|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351842|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351843|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351844|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351845|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351846|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351847|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351848|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351849|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351850|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352054|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
351851|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351852|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351853|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351854|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351855|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351856|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351857|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351858|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351859|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351860|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351861|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351862|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351863|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351864|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351865|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351866|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351867|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351868|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351869|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351870|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351871|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351872|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351873|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351874|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352055|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
351875|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351876|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351877|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351878|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351879|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351880|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351881|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351882|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351883|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351884|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351885|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351886|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351887|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351888|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351889|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351890|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351891|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351892|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351893|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351894|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351895|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351896|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351897|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351898|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352056|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
351899|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351900|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351901|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351902|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351903|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351904|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351905|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351906|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351907|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351908|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351909|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351910|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351911|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351912|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351913|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351914|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351915|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351916|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351917|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351918|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351919|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351920|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351921|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351922|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352057|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
351923|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351924|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351925|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351926|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351927|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351928|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351929|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351930|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351931|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351932|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351933|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351934|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351935|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351936|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351937|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351938|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351939|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351940|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351941|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351942|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351943|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351944|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351945|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351946|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
352058|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
351947|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351948|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351949|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351950|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351951|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351952|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351953|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351954|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351955|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351956|NCT00754065|E2|Reported Event|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
351957|NCT00754065|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
351958|NCT00754013|B3|Baseline|Total|Total of all reporting groups
351959|NCT00754013|B2|Baseline|Placebo|placebo matched to active treatment for oral administration.
351960|NCT00754013|B1|Baseline|Donepezil|Donepezil titrated to a dose of approximately 0.1-0.2 mg/kg/day as the liquid (1 mg/1 mL) or placebo matched to active treatment for oral administration.
351961|NCT00754013|P2|Participant Flow|Placebo|placebo matched to active treatment for oral administration.
351962|NCT00754013|P1|Participant Flow|Donepezil|Donepezil titrated to a dose of approximately 0.1-0.2 mg/kg/day as the liquid (1 mg/1 mL) or placebo matched to active treatment for oral administration.
351963|NCT00754013|O2|Outcome|Placebo|placebo matched to active treatment for oral administration.
351964|NCT00754013|O1|Outcome|Donepezil|Donepezil titrated to a dose of approximately 0.1-0.2 mg/kg/day as the liquid (1 mg/1 mL) or placebo matched to active treatment for oral administration.
351965|NCT00754013|O2|Outcome|Placebo|placebo matched to active treatment for oral administration.
351966|NCT00754013|O1|Outcome|Donepezil|Donepezil titrated to a dose of approximately 0.1-0.2 mg/kg/day as the liquid (1 mg/1 mL) or placebo matched to active treatment for oral administration.
351967|NCT00754013|E2|Reported Event|Placebo|placebo matched to active treatment for oral administration.
351968|NCT00754013|E1|Reported Event|Donepezil|Donepezil titrated to a dose of approximately 0.1-0.2 mg/kg/day as the liquid (1 mg/1 mL) or placebo matched to active treatment for oral administration.
351969|NCT00753948|B4|Baseline|Total|Total of all reporting groups
351970|NCT00753948|B3|Baseline|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351971|NCT00753948|B2|Baseline|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351972|NCT00753948|B1|Baseline|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351973|NCT00753948|P3|Participant Flow|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351974|NCT00753948|P2|Participant Flow|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351975|NCT00753948|P1|Participant Flow|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351976|NCT00753948|O3|Outcome|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351977|NCT00753948|O2|Outcome|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351978|NCT00753948|O1|Outcome|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351979|NCT00753948|E3|Reported Event|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
352059|NCT00752726|E2|Reported Event|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
351980|NCT00753948|E2|Reported Event|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351981|NCT00753948|E1|Reported Event|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
351982|NCT00753922|B5|Baseline|Total|Total of all reporting groups
351983|NCT00753922|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
351984|NCT00753922|B3|Baseline|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
351985|NCT00753922|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
351986|NCT00753922|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
351987|NCT00753922|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
351988|NCT00753922|P3|Participant Flow|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
351989|NCT00753922|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
351990|NCT00753922|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
351991|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
351992|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
351993|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
351994|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
351995|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
351996|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
351997|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
351998|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
351999|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
352000|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
352001|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
352002|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
352003|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
352004|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
352005|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
352006|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
355648|NCT00741026|O2|Outcome|Olanzapine|
352007|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
352008|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
352009|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
352010|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
352011|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
352012|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
352013|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
352014|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
352015|NCT00753922|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
352016|NCT00753922|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
352017|NCT00753922|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
352018|NCT00753922|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
352019|NCT00753896|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352020|NCT00753896|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352021|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352022|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352023|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352024|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352025|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352026|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352027|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352028|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352029|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352030|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352031|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352032|NCT00753896|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
352033|NCT00752726|B3|Baseline|Total|Total of all reporting groups
352034|NCT00752726|B2|Baseline|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
352035|NCT00752726|B1|Baseline|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
352036|NCT00752726|P2|Participant Flow|Placebo|Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
352037|NCT00752726|P1|Participant Flow|Orlistat 60 Milligram (mg)|Orlistat 60 mg capsules taken orally with meals 3 times per day
352038|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352039|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
352040|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352041|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
352042|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352043|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
352044|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352045|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
352046|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352047|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
352048|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352049|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
355649|NCT00741026|O1|Outcome|Placebo|
352060|NCT00752726|E1|Reported Event|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
352061|NCT00753766|B3|Baseline|Total|Total of all reporting groups
352062|NCT00753766|B2|Baseline|Control|Control group
352063|NCT00753766|B1|Baseline|Intervention|"Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.~Multifactorial Intervention: Intervention included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise."
352064|NCT00753766|P2|Participant Flow|Usual Care|Control group
352065|NCT00753766|P1|Participant Flow|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
352066|NCT00753766|O2|Outcome|Usual Care|Control group
352067|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
352068|NCT00753766|O2|Outcome|Usual Care|Control group
352069|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
352070|NCT00753766|E2|Reported Event|Usual Care|Control group
352071|NCT00753766|E1|Reported Event|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
352072|NCT00753714|B3|Baseline|Total|Total of all reporting groups
352073|NCT00753714|B2|Baseline|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352074|NCT00753714|B1|Baseline|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352075|NCT00753714|P2|Participant Flow|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352076|NCT00753714|P1|Participant Flow|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352077|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352078|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352079|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352080|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352081|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352082|NCT00753714|O1|Outcome|ZD6474 ( (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352083|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352084|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352085|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352086|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352087|NCT00753714|E2|Reported Event|Placebo to Match ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
352088|NCT00753714|E1|Reported Event|ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
352089|NCT00753688|B3|Baseline|Total|Total of all reporting groups
352090|NCT00753688|B2|Baseline|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352091|NCT00753688|B1|Baseline|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352092|NCT00753688|P2|Participant Flow|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352093|NCT00753688|P1|Participant Flow|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352094|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352095|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352096|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352097|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352098|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352099|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352100|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352101|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352102|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352103|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352104|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352105|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352106|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352107|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352108|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352109|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352110|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352111|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352112|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352113|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352114|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352115|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352116|NCT00753688|E2|Reported Event|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352117|NCT00753688|E1|Reported Event|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
352118|NCT00753675|B4|Baseline|Total|Total of all reporting groups
352119|NCT00753675|B3|Baseline|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352120|NCT00753675|B2|Baseline|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352121|NCT00753675|B1|Baseline|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352122|NCT00753675|P3|Participant Flow|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352123|NCT00753675|P2|Participant Flow|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352124|NCT00753675|P1|Participant Flow|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352125|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352126|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352127|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352207|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352208|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352734|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352128|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352129|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352130|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352131|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352132|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352133|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352134|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352135|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352136|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352137|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352138|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352139|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352140|NCT00753675|E3|Reported Event|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
352141|NCT00753675|E2|Reported Event|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
352142|NCT00753675|E1|Reported Event|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
352143|NCT00753649|B3|Baseline|Total|Total of all reporting groups
352144|NCT00753649|B2|Baseline|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352145|NCT00753649|B1|Baseline|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352146|NCT00753649|P2|Participant Flow|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352147|NCT00753649|P1|Participant Flow|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352209|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352210|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352148|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352149|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352150|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352151|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352152|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352153|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352154|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352155|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352156|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352157|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352158|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352159|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352160|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352161|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352211|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352212|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352162|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352163|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352164|NCT00753649|E2|Reported Event|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352165|NCT00753649|E1|Reported Event|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
352166|NCT00753636|B1|Baseline|Isradipine 20mg, 15mg, 10mg or 5 mg|
352167|NCT00753636|P1|Participant Flow|Isradipine 20mg, 15mg, 10mg or 5 mg|
352168|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352169|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352170|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352171|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352172|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352173|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352174|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
352175|NCT00753636|E1|Reported Event|Isradipine 20mg, 15mg, 10mg or 5 mg|
352176|NCT00753623|B4|Baseline|Total|Total of all reporting groups
352177|NCT00753623|B3|Baseline|Placebo and Ramelteon|"In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352178|NCT00753623|B2|Baseline|Ramelteon|"In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352179|NCT00753623|B1|Baseline|Placebo|"In a crossover design, a subject was first assigned to the placebo or ramelteon and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352180|NCT00753623|P2|Participant Flow|Ramelton-placebo|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
352181|NCT00753623|P1|Participant Flow|Placebo-ramelteon|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
352182|NCT00753623|O1|Outcome|Placebo-controlled Crossover|"In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352183|NCT00753623|E2|Reported Event|Placebo|"In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352184|NCT00753623|E1|Reported Event|Ramelteon (8mg)|"In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.~Ramelteon : ramelteon (8 mg)"
352185|NCT00753545|B3|Baseline|Total|Total of all reporting groups
352186|NCT00753545|B2|Baseline|Placebo bd|Olaparib matching placebo oral capsules twice daily
352187|NCT00753545|B1|Baseline|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352188|NCT00753545|P2|Participant Flow|Placebo bd|Olaparib matching placebo oral capsules twice daily
352189|NCT00753545|P1|Participant Flow|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352190|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352191|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352192|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352193|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352194|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352195|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352196|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352197|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352198|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352199|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352200|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352201|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352202|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352203|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352204|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352205|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352206|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352735|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352213|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352214|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352215|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352216|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352217|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352218|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352219|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352220|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
352221|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352222|NCT00753545|E2|Reported Event|Placebo bd|Olaparib matching placebo oral capsules twice daily
352223|NCT00753545|E1|Reported Event|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
352224|NCT00753519|B3|Baseline|Total|Total of all reporting groups
352225|NCT00753519|B2|Baseline|Sham iTBS|Sham iTBS
352226|NCT00753519|B1|Baseline|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
352227|NCT00753519|P2|Participant Flow|Sham iTBS|Sham iTBS
352228|NCT00753519|P1|Participant Flow|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
352229|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
352230|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
352231|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
352232|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
352233|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
352234|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
352235|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
352236|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
352237|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
352238|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
352239|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
352240|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
352241|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
352242|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
352243|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
352244|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
352245|NCT00753519|E2|Reported Event|Sham iTBS|Sham iTBS
352246|NCT00753519|E1|Reported Event|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
352247|NCT00753506|B3|Baseline|Total|Total of all reporting groups
352248|NCT00753506|B2|Baseline|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
352249|NCT00753506|B1|Baseline|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
352250|NCT00753506|P2|Participant Flow|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
352251|NCT00753506|P1|Participant Flow|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
352252|NCT00753506|O2|Outcome|Placebo|100 mg artemisinin identical placebo capsule taken twice per day.
352253|NCT00753506|O1|Outcome|Artemisinin|100 mg capsule of artemisinin taken twice per day.
352254|NCT00753506|E2|Reported Event|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
352311|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352736|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352255|NCT00753506|E1|Reported Event|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
352256|NCT00753454|B1|Baseline|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352257|NCT00753454|P1|Participant Flow|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352258|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352259|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352260|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352261|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352262|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352263|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352264|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352265|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352266|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352267|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352268|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352347|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352269|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352270|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352271|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352272|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352273|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352274|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352275|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352276|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352277|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352278|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352279|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352280|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352281|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352282|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352312|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
355650|NCT00741026|O2|Outcome|Olanzapine|
352283|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352284|NCT00753454|E1|Reported Event|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
352285|NCT00753415|B6|Baseline|Total|Total of all reporting groups
352286|NCT00753415|B5|Baseline|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352287|NCT00753415|B4|Baseline|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352288|NCT00753415|B3|Baseline|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
352289|NCT00753415|B2|Baseline|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352290|NCT00753415|B1|Baseline|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352291|NCT00753415|P10|Participant Flow|Part B: V934 HD(5)+V934 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352292|NCT00753415|P9|Participant Flow|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352293|NCT00753415|P8|Participant Flow|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352294|NCT00753415|P7|Participant Flow|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352295|NCT00753415|P6|Participant Flow|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
352296|NCT00753415|P5|Participant Flow|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352297|NCT00753415|P4|Participant Flow|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352298|NCT00753415|P3|Participant Flow|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
352299|NCT00753415|P2|Participant Flow|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352300|NCT00753415|P1|Participant Flow|Part A: V935 LD|Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352301|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352302|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352303|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
352304|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352305|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352306|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352307|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352308|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
352309|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352310|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352313|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352314|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352315|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352316|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352317|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352318|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
352319|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352320|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352321|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352322|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352323|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352324|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352325|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352326|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352327|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352328|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
352329|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352330|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352331|NCT00753415|E10|Reported Event|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352332|NCT00753415|E9|Reported Event|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352333|NCT00753415|E8|Reported Event|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352334|NCT00753415|E7|Reported Event|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352335|NCT00753415|E6|Reported Event|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
352336|NCT00753415|E5|Reported Event|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352337|NCT00753415|E4|Reported Event|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
352338|NCT00753415|E3|Reported Event|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
352339|NCT00753415|E2|Reported Event|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
352340|NCT00753415|E1|Reported Event|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
352341|NCT00753363|B3|Baseline|Total|Total of all reporting groups
352342|NCT00753363|B2|Baseline|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352343|NCT00753363|B1|Baseline|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352344|NCT00753363|P2|Participant Flow|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352345|NCT00753363|P1|Participant Flow|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352346|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352348|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352349|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352350|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352351|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352352|NCT00753363|E2|Reported Event|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
352353|NCT00753363|E1|Reported Event|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
352354|NCT00753337|B1|Baseline|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352355|NCT00753337|P1|Participant Flow|Assurant Cobalt Iliac Stent|Cobalt stent implanted using standard percutaneous intervention technique.
352356|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting.
352357|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352358|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352359|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352360|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352361|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352362|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352363|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352364|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352365|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352366|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
352367|NCT00753337|E1|Reported Event|Assurant Cobalt Iliac Stent|Treatment with Iliac stenting system
352368|NCT00753298|B3|Baseline|Total|Total of all reporting groups
352369|NCT00753298|B2|Baseline|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352370|NCT00753298|B1|Baseline|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352371|NCT00753298|P2|Participant Flow|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352372|NCT00753298|P1|Participant Flow|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352373|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352374|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352375|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352376|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352377|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352378|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352379|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352380|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352381|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352382|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352383|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352384|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352385|NCT00753298|E2|Reported Event|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
352386|NCT00753298|E1|Reported Event|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
352387|NCT00753272|B3|Baseline|Total|Total of all reporting groups
352388|NCT00753272|B2|Baseline|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352389|NCT00753272|B1|Baseline|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352390|NCT00753272|P2|Participant Flow|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352391|NCT00753272|P1|Participant Flow|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352392|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
352393|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
352394|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
352395|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352396|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352397|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352563|NCT00752232|B7|Baseline|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352398|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352399|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352400|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352401|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352402|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352403|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352404|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352405|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352406|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352407|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352408|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352409|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352410|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352411|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352412|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352413|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352414|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352415|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352416|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352417|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352418|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352419|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352420|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352421|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352422|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352423|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352424|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352425|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
355651|NCT00741026|O1|Outcome|Placebo|
352426|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352427|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352428|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352429|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352430|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352431|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352432|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352433|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352434|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352435|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352436|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352437|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352438|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352439|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352440|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352441|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352442|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352443|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352444|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352445|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352446|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352447|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
352448|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
352449|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
352450|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352451|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352452|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352453|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
355652|NCT00741026|O2|Outcome|Olanzapine|
352454|NCT00753272|E2|Reported Event|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352455|NCT00753272|E1|Reported Event|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
352456|NCT00753220|B1|Baseline|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
352457|NCT00753220|P1|Participant Flow|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
352458|NCT00753220|O1|Outcome|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
352459|NCT00753220|E1|Reported Event|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
352460|NCT00753142|B4|Baseline|Total|Total of all reporting groups
352461|NCT00753142|B3|Baseline|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
352462|NCT00753142|B2|Baseline|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
352463|NCT00753142|B1|Baseline|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
352464|NCT00753142|P3|Participant Flow|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
352465|NCT00753142|P2|Participant Flow|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
352466|NCT00753142|P1|Participant Flow|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
352467|NCT00753142|O3|Outcome|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
352468|NCT00753142|O2|Outcome|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
352469|NCT00753142|O1|Outcome|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
352470|NCT00753142|E3|Reported Event|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
352471|NCT00753142|E2|Reported Event|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
352472|NCT00753142|E1|Reported Event|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
352473|NCT00753012|B3|Baseline|Total|Total of all reporting groups
352474|NCT00753012|B2|Baseline|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
352475|NCT00753012|B1|Baseline|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
352476|NCT00753012|P2|Participant Flow|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
352477|NCT00753012|P1|Participant Flow|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
352478|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
352479|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
352480|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
352481|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
352482|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
352483|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
352484|NCT00753012|E2|Reported Event|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
352485|NCT00753012|E1|Reported Event|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
352486|NCT00752986|B4|Baseline|Total|Total of all reporting groups
352487|NCT00752986|B3|Baseline|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352488|NCT00752986|B2|Baseline|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352489|NCT00752986|B1|Baseline|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352564|NCT00752232|B6|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
355653|NCT00741026|O1|Outcome|Placebo|
352490|NCT00752986|P3|Participant Flow|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352491|NCT00752986|P2|Participant Flow|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352492|NCT00752986|P1|Participant Flow|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352493|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352494|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352495|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352496|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352497|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352498|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352499|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352500|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352501|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352502|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352503|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352504|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352505|NCT00752986|E3|Reported Event|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
352506|NCT00752986|E2|Reported Event|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352507|NCT00752986|E1|Reported Event|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
352508|NCT00752973|B1|Baseline|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
352509|NCT00752973|P1|Participant Flow|Malathion Gel 0.5% Treatment Arm|"Malathion Gel 0.5% treatment~MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes"
352510|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
352511|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
352512|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
352513|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
352514|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
352515|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator."
352737|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352516|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
352517|NCT00752973|E1|Reported Event|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
352518|NCT00752895|B3|Baseline|Total|Total of all reporting groups
352519|NCT00752895|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
352520|NCT00752895|B1|Baseline|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
352521|NCT00752895|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
352522|NCT00752895|P1|Participant Flow|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
352523|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
352524|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
352525|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
352526|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
352527|NCT00752895|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
352528|NCT00752895|E1|Reported Event|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
352529|NCT00752622|B1|Baseline|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352530|NCT00752622|P1|Participant Flow|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352531|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352532|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352533|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352534|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352535|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352536|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352537|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
352538|NCT00752622|E2|Reported Event|Infliximab 5 mg/kg Then Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants were then randomized to receive 5 mg/kg every 6 weeks (shortened interval group) or 7 mg/kg every 8 weeks (increased dose group) at entry into the interventional phase. This reporting group included 3 participants randomized into the shortened interval group and 5 participants randomized into the increased dose group.
352539|NCT00752622|E1|Reported Event|Infliximab 5 mg/kg Then Not Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants who were further randomized into the interventional phase are not included in this reporting group; therefore, of the 100 enrolled participants, 92 participants were included in this safety reporting group.
352540|NCT00752609|B3|Baseline|Total|Total of all reporting groups
352541|NCT00752609|B2|Baseline|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352542|NCT00752609|B1|Baseline|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352543|NCT00752609|P2|Participant Flow|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352565|NCT00752232|B5|Baseline|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352738|NCT00751881|O1|Outcome|Placebo|Placebo once daily
445463|NCT00502775|O1|Outcome|Placebo|
352544|NCT00752609|P1|Participant Flow|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352545|NCT00752609|O3|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352546|NCT00752609|O2|Outcome|SC Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous (SC) injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352547|NCT00752609|O1|Outcome|IV Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide intravenous (IV) injection once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352548|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352549|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352550|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352551|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352552|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352553|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352554|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352555|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352556|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352557|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352558|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352559|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352560|NCT00752609|E2|Reported Event|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352561|NCT00752609|E1|Reported Event|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
352562|NCT00752232|B8|Baseline|Total|Total of all reporting groups
352566|NCT00752232|B4|Baseline|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352567|NCT00752232|B3|Baseline|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
352568|NCT00752232|B2|Baseline|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352569|NCT00752232|B1|Baseline|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352570|NCT00752232|P7|Participant Flow|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352571|NCT00752232|P6|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352572|NCT00752232|P5|Participant Flow|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352573|NCT00752232|P4|Participant Flow|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352574|NCT00752232|P3|Participant Flow|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
352575|NCT00752232|P2|Participant Flow|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352576|NCT00752232|P1|Participant Flow|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352577|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352578|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352579|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352580|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352581|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352582|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352583|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352584|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352585|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352586|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352587|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352588|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352589|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352590|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352591|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352592|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352593|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352594|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352595|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352596|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352597|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352598|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352599|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352600|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352601|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352732|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352733|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352602|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352603|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352604|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352605|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352606|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352607|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352608|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352609|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352610|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352611|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352612|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352613|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352614|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352615|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352616|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352617|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352618|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352619|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352620|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352621|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352622|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352623|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352624|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352625|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352626|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352627|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352628|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352629|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352630|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
352631|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352632|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352633|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352634|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352635|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352636|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
352637|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
352638|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352639|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352640|NCT00752232|E7|Reported Event|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
352641|NCT00752232|E6|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352642|NCT00752232|E5|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
352643|NCT00752232|E4|Reported Event|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12
352644|NCT00752232|E3|Reported Event|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
352645|NCT00752232|E2|Reported Event|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
352646|NCT00752232|E1|Reported Event|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
352647|NCT00752128|B1|Baseline|Resolute Drug-Eluting Stent|
352648|NCT00752128|P1|Participant Flow|Resolute Drug-Eluting Stent|
352649|NCT00752128|O1|Outcome|Overall Stent Thrombosis (Definite and Probable-ARC)|Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition
352650|NCT00752128|O1|Outcome|Cardiac Death or Target Vessel MI|Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
352651|NCT00752128|E1|Reported Event|Resolute Drug-Eluting Stent|
352652|NCT00752089|B1|Baseline|Overall Study Participants|All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
352653|NCT00752089|P1|Participant Flow|Overall Study|This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
352654|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
352655|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
352656|NCT00752089|O2|Outcome|NaF/ KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
352657|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
352658|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
352659|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
352660|NCT00752089|O2|Outcome|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
352661|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
352662|NCT00752089|E4|Reported Event|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
352663|NCT00752089|E3|Reported Event|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
352664|NCT00752089|E2|Reported Event|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
352665|NCT00752089|E1|Reported Event|NaF/ KNO3/ 2 % Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
352666|NCT00751998|B1|Baseline|Arm 1|Test of SpyGlass device
352667|NCT00751998|P1|Participant Flow|Arm 1|Test of SpyGlass device
352668|NCT00751998|O1|Outcome|Arm 1|Test of SpyGlass device
352669|NCT00751998|E1|Reported Event|Arm 1|Test of SpyGlass device
352670|NCT00751972|B3|Baseline|Total|Total of all reporting groups
352671|NCT00751972|B2|Baseline|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.
352672|NCT00751972|B1|Baseline|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352673|NCT00751972|P2|Participant Flow|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
352674|NCT00751972|P1|Participant Flow|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352675|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352676|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352677|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352678|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352679|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352680|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
352681|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352682|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
352683|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352684|NCT00751972|E1|Reported Event|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
352685|NCT00751933|B1|Baseline|All Arms|Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
352686|NCT00751933|P4|Participant Flow|Vaccine and Oats 1|"Vaccination with Vivotif and Dukoral + dietary supplement with oats.~Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.~Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.~One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
352687|NCT00751933|P3|Participant Flow|Placebo 4|"Placebo instead of vaccines No dietary supplement~Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine"
352688|NCT00751933|P2|Participant Flow|Oats Supplement 3|"Dietary supplement with oats~Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
352689|NCT00751933|P1|Participant Flow|Vaccine Arm 2|"Vaccination with Vivotif and Dukoral~Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14."
352690|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
352691|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
352692|NCT00751933|E1|Reported Event|All Arms|No adverse effects were recorded.
352693|NCT00751881|B4|Baseline|Total|Total of all reporting groups
352694|NCT00751881|B3|Baseline|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352695|NCT00751881|B2|Baseline|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352696|NCT00751881|B1|Baseline|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352697|NCT00751881|P3|Participant Flow|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352698|NCT00751881|P2|Participant Flow|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352699|NCT00751881|P1|Participant Flow|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352700|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352701|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352702|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352703|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352704|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352705|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352706|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352707|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352708|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352709|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352710|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352711|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352712|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352713|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352714|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352715|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352716|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352717|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352718|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352719|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352720|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352721|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352722|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352723|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352724|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352725|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352726|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352727|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352728|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352729|NCT00751881|O1|Outcome|Placebo|Placebo once daily
352730|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352731|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352739|NCT00751881|E6|Reported Event|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352740|NCT00751881|E5|Reported Event|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
352741|NCT00751881|E4|Reported Event|Placebo / 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily
352742|NCT00751881|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
352743|NCT00751881|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
352744|NCT00751881|E1|Reported Event|Placebo|Placebo once daily
352745|NCT00751790|B1|Baseline|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
352746|NCT00751790|P1|Participant Flow|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
352747|NCT00751790|O1|Outcome|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
352748|NCT00751790|E1|Reported Event|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
352749|NCT00751777|B3|Baseline|Total|Total of all reporting groups
352750|NCT00751777|B2|Baseline|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352751|NCT00751777|B1|Baseline|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352752|NCT00751777|P2|Participant Flow|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352753|NCT00751777|P1|Participant Flow|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352754|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352755|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352756|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352757|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352758|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352759|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352760|NCT00751777|E2|Reported Event|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
352761|NCT00751777|E1|Reported Event|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
352762|NCT00751634|B1|Baseline|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352763|NCT00751634|P1|Participant Flow|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352764|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352765|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352766|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352767|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352768|NCT00751634|O1|Outcome|Treatment Group at 0, 1, 2, 6 Hours|Application of the Gaymar Rapr-Round device per approved use
352769|NCT00751634|E1|Reported Event|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
352770|NCT00751621|B1|Baseline|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352771|NCT00751621|P1|Participant Flow|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352772|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352773|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352774|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352775|NCT00751621|O2|Outcome|IgPro20 - At End of Study|SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
352776|NCT00751621|O1|Outcome|IgPro20 - At Baseline|SF-36 score at baseline.
352777|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352778|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352779|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352780|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352867|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352781|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352782|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352783|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352784|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352785|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352786|NCT00751621|E1|Reported Event|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
352787|NCT00751530|B3|Baseline|Total|Total of all reporting groups
352788|NCT00751530|B2|Baseline|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352789|NCT00751530|B1|Baseline|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352790|NCT00751530|P2|Participant Flow|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352791|NCT00751530|P1|Participant Flow|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352792|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352793|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352794|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352795|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352796|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352797|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352798|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352799|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352800|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352801|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352802|NCT00751530|E2|Reported Event|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
352803|NCT00751530|E1|Reported Event|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
352804|NCT00751400|B1|Baseline|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352805|NCT00751400|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352806|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352807|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352808|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352809|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352810|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352811|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352812|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352813|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352814|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352815|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352816|NCT00751400|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
352941|NCT00750867|P1|Participant Flow|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
352817|NCT00751296|B1|Baseline|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles)."
352818|NCT00751296|P1|Participant Flow|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
352819|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
352820|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
352821|NCT00751296|E1|Reported Event|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
352822|NCT00751179|B3|Baseline|Total|Total of all reporting groups
352823|NCT00751179|B2|Baseline|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352824|NCT00751179|B1|Baseline|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352825|NCT00751179|P2|Participant Flow|Succinylcholine|An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352826|NCT00751179|P1|Participant Flow|Rocuronium - Sugammadex|An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
352827|NCT00751179|O1|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352828|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352829|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352830|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352831|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352832|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352833|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352834|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352835|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352836|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352837|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
355654|NCT00741026|E2|Reported Event|Olanzapine|
352838|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352839|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352840|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352841|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352842|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352843|NCT00751179|E2|Reported Event|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
352844|NCT00751179|E1|Reported Event|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
352845|NCT00751140|B1|Baseline|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
352846|NCT00751140|P1|Participant Flow|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
352847|NCT00751140|O4|Outcome|Robot-assisted RNU Lymph Node Count|Lymph Node Count for Robot-assisted RNU Procedure Group
352848|NCT00751140|O3|Outcome|Laparoscopic RNU Lymph Node Count|Lymph Node Count for Laparoscopic RNU Procedure Group
352849|NCT00751140|O2|Outcome|Open RNU Lymph Node Count|Lymph Node Count for Open RNU Procedure Group
352850|NCT00751140|O1|Outcome|Total Lymph Node Count|Total Lymph Node Count for All Participants
352851|NCT00751140|O1|Outcome|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
352852|NCT00751140|E1|Reported Event|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
352853|NCT00751114|B3|Baseline|Total|Total of all reporting groups
352854|NCT00751114|B2|Baseline|Sitagliptin|Dose of 100 mg once a day administered with or without food
352855|NCT00751114|B1|Baseline|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352856|NCT00751114|P2|Participant Flow|Sitagliptin|Dose of 100 mg once a day administered with or without food
352857|NCT00751114|P1|Participant Flow|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352858|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352859|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352860|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352861|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352862|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352863|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352864|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352865|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352866|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352868|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352869|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352870|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352871|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352872|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352873|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352874|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352875|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
352876|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352877|NCT00751114|E2|Reported Event|Sitagliptin|Dose of 100 mg once a day administered with or without food
352878|NCT00751114|E1|Reported Event|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
352879|NCT00751036|B3|Baseline|Total|Total of all reporting groups
352880|NCT00751036|B2|Baseline|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352881|NCT00751036|B1|Baseline|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352882|NCT00751036|P2|Participant Flow|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352883|NCT00751036|P1|Participant Flow|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352884|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352885|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352886|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352887|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352888|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352889|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352890|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352891|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352892|NCT00751036|E2|Reported Event|Imatinib 800 mg|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
352893|NCT00751036|E1|Reported Event|Nilotinib 800 mg|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
352894|NCT00750919|B1|Baseline|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352895|NCT00750919|P1|Participant Flow|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352896|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352897|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352898|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352899|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352900|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352901|NCT00750919|E1|Reported Event|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
352902|NCT00750893|B1|Baseline|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352903|NCT00750893|P1|Participant Flow|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352904|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352905|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352906|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352942|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
352907|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352908|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352909|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352910|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352911|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352912|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
352913|NCT00750893|E4|Reported Event|Rotarix Year 1 to Year 6 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during the study period from Year 1 to Year 6.
352914|NCT00750893|E3|Reported Event|Rotarix Year 5 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Year 5 of the study.
352915|NCT00750893|E2|Reported Event|Rotarix Years 3 and 4 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 3 and 4 of the study.
352916|NCT00750893|E1|Reported Event|Rotarix Years 1 and 2 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 1 and 2 of the study.
352917|NCT00750880|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352918|NCT00750880|P1|Participant Flow|Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
352919|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352920|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352921|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352922|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352923|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352924|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352925|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352926|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352927|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352928|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352929|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352930|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352931|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352932|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352933|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352934|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
352935|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352936|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
352937|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352938|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
352939|NCT00750880|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
352940|NCT00750867|B1|Baseline|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
352955|NCT00750815|E4|Reported Event|Maximum Tolerated Dose|Participants at Dose Level 4
352943|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
352944|NCT00750867|E1|Reported Event|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
352945|NCT00750815|B3|Baseline|Total|Total of all reporting groups
352946|NCT00750815|B2|Baseline|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
352947|NCT00750815|B1|Baseline|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
352948|NCT00750815|P2|Participant Flow|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
352949|NCT00750815|P1|Participant Flow|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
352950|NCT00750815|O2|Outcome|Standard-Risk Myeloma|"Participants eligible for risk stratification with Standard-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule Arm A."
352951|NCT00750815|O1|Outcome|High-Risk Myeloma|"Participants eligible for risk stratification with High-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as Arm A."
352952|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
352953|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
352954|NCT00750815|O1|Outcome|A. Phase I Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
352956|NCT00750815|E3|Reported Event|Dose Level 3|Participants at Dose Level 3
352957|NCT00750815|E2|Reported Event|Dose Level 2|Participants at Dose Level 2
352958|NCT00750815|E1|Reported Event|Dose Level 1|Participants at Dose Level 1
352959|NCT00750737|B3|Baseline|Total|Total of all reporting groups
352960|NCT00750737|B2|Baseline|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
352961|NCT00750737|B1|Baseline|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
352962|NCT00750737|P2|Participant Flow|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
352963|NCT00750737|P1|Participant Flow|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
352964|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
352965|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
352966|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
352967|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
352968|NCT00750737|E2|Reported Event|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
352969|NCT00750737|E1|Reported Event|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
352970|NCT00750373|B3|Baseline|Total|Total of all reporting groups
352971|NCT00750373|B2|Baseline|Surgery|Early surgery within 48 hours of randomization
352972|NCT00750373|B1|Baseline|Conventional|Conventional Treatment based on current guidelines
352973|NCT00750373|P2|Participant Flow|Surgery|Early surgery within 48 hours of randomization
352974|NCT00750373|P1|Participant Flow|Conventional|Conventional Treatment based on current guidelines
352975|NCT00750373|O2|Outcome|Surgery|Early surgery within 48 hours of randomization
352976|NCT00750373|O1|Outcome|Conventional|Conventional Treatment based on current guidelines
352977|NCT00750373|E2|Reported Event|Surgery|Early surgery within 48 hours of randomization
352978|NCT00750373|E1|Reported Event|Conventional|Conventional Treatment based on current guidelines
352979|NCT00750360|B7|Baseline|Total|Total of all reporting groups
352980|NCT00750360|B6|Baseline|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
352981|NCT00750360|B5|Baseline|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
352982|NCT00750360|B4|Baseline|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
352983|NCT00750360|B3|Baseline|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
352984|NCT00750360|B2|Baseline|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
352985|NCT00750360|B1|Baseline|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
352986|NCT00750360|P6|Participant Flow|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
352987|NCT00750360|P5|Participant Flow|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
352988|NCT00750360|P4|Participant Flow|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
352989|NCT00750360|P3|Participant Flow|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
352990|NCT00750360|P2|Participant Flow|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
352991|NCT00750360|P1|Participant Flow|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
352992|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
352993|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
352994|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
352995|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
352996|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
352997|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
352998|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
352999|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
353000|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
353001|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
353002|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
353003|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
353004|NCT00750360|O4|Outcome|Group A (Primed), ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
353005|NCT00750360|O3|Outcome|Group A (Primed), ≥ 108 Months to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
353006|NCT00750360|O2|Outcome|Group A (Primed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
353007|NCT00750360|O1|Outcome|Group B (Unprimed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
353008|NCT00750360|O2|Outcome|Group A (Primed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
353009|NCT00750360|O1|Outcome|Group B (Unprimed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
353010|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
353011|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
353012|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
353013|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
353014|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
353015|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
353016|NCT00750360|E6|Reported Event|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
353017|NCT00750360|E5|Reported Event|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
353018|NCT00750360|E4|Reported Event|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
353019|NCT00750360|E3|Reported Event|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
353020|NCT00750360|E2|Reported Event|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
353021|NCT00750360|E1|Reported Event|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
353022|NCT00750308|B1|Baseline|Completed Subjects|Subjects who completed all four treatment arms.
353023|NCT00750308|P12|Participant Flow|Placebo, Ramipril, Tadalafil, Combo|
353024|NCT00750308|P11|Participant Flow|Combo, Tadalafil, Ramipril, Placebo|
353025|NCT00750308|P10|Participant Flow|Ramipril, Placebo, Combo, Tadalafil|
353026|NCT00750308|P9|Participant Flow|Tadalafil, Combo, Placebo, Ramipril|
353027|NCT00750308|P8|Participant Flow|Placebo, Tadalafil, Combo, Ramipril|
353028|NCT00750308|P7|Participant Flow|Combo, Ramipril, Placebo, Tadalafil|
353029|NCT00750308|P6|Participant Flow|Ramipril, Combo, Tadalafil, Placebo|
353030|NCT00750308|P5|Participant Flow|Tadalafil, Placebo, Ramipril, Combo|
353031|NCT00750308|P4|Participant Flow|Placebo, Combo, Ramipril, Tadalafil|
353032|NCT00750308|P3|Participant Flow|Combo, Placebo, Tadalafil, Ramipril|
353033|NCT00750308|P2|Participant Flow|Ramipril, Tadalafil, Placebo, Combo|
353034|NCT00750308|P1|Participant Flow|Tadalafil, Ramipril, Combo, Placebo|
353035|NCT00750308|O4|Outcome|Combination Treatment|Measured during combination (ramipril and tadalafil) in all 18 subjects who completed treatment
353036|NCT00750308|O3|Outcome|Tadalafil Treatment|Measured during tadalafil in all 18 subjects who completed the protocol
353037|NCT00750308|O2|Outcome|Ramipril Treatment|Measured during ramipril treatment in all 18 subjects who completed the protocol
353038|NCT00750308|O1|Outcome|Placebo Treatment|Measured during placebo treatment in all 18 subjects who completed the study
353039|NCT00750308|O4|Outcome|Combination Treatment|Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
353040|NCT00750308|O3|Outcome|Tadalafil Treatment|Measurements during tadalafil treatment for all 18 subjects who completed the protocol
353041|NCT00750308|O2|Outcome|Ramipril Treatment|Measurements during ramipril treatment for all 18 subjects who completed the protocol
353042|NCT00750308|O1|Outcome|Placeb Treatment|Measurements during placebo treatment for all 18 subjects who completed the protocol
353043|NCT00750308|E4|Reported Event|Combination Treatment|Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
353044|NCT00750308|E3|Reported Event|Tadalafil Tretament|Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
353045|NCT00750308|E2|Reported Event|Ramipril Treatment|Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
353046|NCT00750308|E1|Reported Event|Placebo Treatment|Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
353047|NCT00750282|B5|Baseline|Total|Total of all reporting groups
353048|NCT00750282|B4|Baseline|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353049|NCT00750282|B3|Baseline|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353111|NCT00750139|P2|Participant Flow|Placebo 2-wks|Placebo applied daily for 2-weeks
353050|NCT00750282|B2|Baseline|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353051|NCT00750282|B1|Baseline|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353052|NCT00750282|P4|Participant Flow|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353053|NCT00750282|P3|Participant Flow|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353054|NCT00750282|P2|Participant Flow|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353055|NCT00750282|P1|Participant Flow|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
353056|NCT00750282|O4|Outcome|Healthy Volunteer (HV) Group (Part B)|All subjects that were confirmed by consensus panel as healthy volunteers
353057|NCT00750282|O3|Outcome|Alzheimer's (AD) Group (Part B)|"All subjects with consensus panel based diagnosis of probable AD"
353058|NCT00750282|O2|Outcome|Healthy Volunteer (HV) Group (Part A)|All evaluated healthy volunteers
353059|NCT00750282|O1|Outcome|Alzheimer's (AD) Group (Part A)|All evaluated subjects with Alzheimer's disease
353060|NCT00750282|O6|Outcome|Imaging Window 110-130 Min Part B|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
353061|NCT00750282|O5|Outcome|Imaging Window 90-110 Min Part B|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B
353062|NCT00750282|O4|Outcome|Imaging Window 45-60 Min Part B|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part B
353063|NCT00750282|O3|Outcome|Imaging Window 110-130 Min Part A|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part A.
353064|NCT00750282|O2|Outcome|Imaging Window 90-110 Min Part A|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part A
353065|NCT00750282|O1|Outcome|Imaging Window 45-60 Min Part A|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part A
353066|NCT00750282|O4|Outcome|HV (Specificity) Group (Part B)|All evaluated healthy volunteers from Part B
353067|NCT00750282|O3|Outcome|AD (Sensitivity) Group (Part B)|All evaluated subjects with probable Alzheimer's disease from part B
353068|NCT00750282|O2|Outcome|HV (Specificity) Group (Part A)|All evaluated healthy volunteers from Part A
353069|NCT00750282|O1|Outcome|AD (Sensitivity) Group (Part A)|All evaluated subjects with Alzheimer's disease from Part A
353070|NCT00750282|O2|Outcome|HV (Specificity) Group|All subjects evaluated as healthy volunteer by consensus panel
353071|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All subjects evaluated as probable AD by consensus panel
353072|NCT00750282|O2|Outcome|HV (Specificity) Group|All evaluated healthy volunteers
353073|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All evaluated subjects with Alzheimer's disease
353074|NCT00750282|E4|Reported Event|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353075|NCT00750282|E3|Reported Event|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353076|NCT00750282|E2|Reported Event|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353077|NCT00750282|E1|Reported Event|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
353078|NCT00750191|B3|Baseline|Total|Total of all reporting groups
353079|NCT00750191|B2|Baseline|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353080|NCT00750191|B1|Baseline|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353081|NCT00750191|P2|Participant Flow|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353082|NCT00750191|P1|Participant Flow|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353083|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353084|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353085|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353086|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353087|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353088|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353089|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353090|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353091|NCT00750191|E2|Reported Event|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
353092|NCT00750191|E1|Reported Event|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
353093|NCT00750152|B3|Baseline|Total|Total of all reporting groups
353094|NCT00750152|B2|Baseline|Placebo-2wks|Placebo cream applied daily for 2 weeks
353095|NCT00750152|B1|Baseline|NAFT-500|Naftin 2% cream applied daily for 2 weeks
353096|NCT00750152|P2|Participant Flow|Placebo-2wks|Placebo cream applied daily for 2 weeks
353097|NCT00750152|P1|Participant Flow|NAFT-500|Naftin 2% cream applied daily for 2 weeks
353098|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
353099|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
353100|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
353101|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
353102|NCT00750152|E2|Reported Event|Placebo-2wks|Placebo cream applied daily for 2 weeks
353103|NCT00750152|E1|Reported Event|NAFT-500|Naftin 2% cream applied daily for 2 weeks
353104|NCT00750139|B5|Baseline|Total|Total of all reporting groups
353105|NCT00750139|B4|Baseline|Placebo 4-wks|Placebo cream applied daily for 4 weeks
353106|NCT00750139|B3|Baseline|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
353107|NCT00750139|B2|Baseline|Placebo 2-wks|Placebo applied daily for 2-weeks
353108|NCT00750139|B1|Baseline|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
353109|NCT00750139|P4|Participant Flow|Placebo 4-wks|Placebo cream applied daily for 4 weeks
353110|NCT00750139|P3|Participant Flow|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
353112|NCT00750139|P1|Participant Flow|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
353113|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo cream applied daily for 4 weeks
353114|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
353115|NCT00750139|O2|Outcome|Placebo 2-wks|Placebo applied daily for 2-weeks
353116|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
353117|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo control cream applied daily for 4 weeks
353118|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
353119|NCT00750139|O2|Outcome|Placebo 2-weeks|Placebo Control cream applied daily for 2-weeks
353120|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
353121|NCT00750139|E4|Reported Event|Placebo 4-wks|Placebo cream applied daily for 4 weeks
353122|NCT00750139|E3|Reported Event|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
353123|NCT00750139|E2|Reported Event|Placebo 2-wks|Placebo applied daily for 2-weeks
353124|NCT00750139|E1|Reported Event|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
353125|NCT00750061|B3|Baseline|Total|Total of all reporting groups
353126|NCT00750061|B2|Baseline|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
353127|NCT00750061|B1|Baseline|Placebo|"Placebo~Placebo: Matching placebo"
353128|NCT00750061|P2|Participant Flow|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
353129|NCT00750061|P1|Participant Flow|Placebo|Placebo: Matching placebo
353130|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
353131|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
353132|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
353133|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
353134|NCT00750061|E2|Reported Event|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
353135|NCT00750061|E1|Reported Event|Placebo|Placebo: Matching placebo
353136|NCT00749996|B3|Baseline|Total|Total of all reporting groups
353137|NCT00749996|B2|Baseline|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
353138|NCT00749996|B1|Baseline|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
353139|NCT00749996|P2|Participant Flow|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
353140|NCT00749996|P1|Participant Flow|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
353141|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
353142|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
353143|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
353144|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
353145|NCT00749996|E2|Reported Event|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
353146|NCT00749996|E1|Reported Event|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
353147|NCT00749957|B3|Baseline|Total|Total of all reporting groups
353148|NCT00749957|B2|Baseline|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353149|NCT00749957|B1|Baseline|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353150|NCT00749957|P2|Participant Flow|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353151|NCT00749957|P1|Participant Flow|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353152|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353153|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353154|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353155|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353156|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353157|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353158|NCT00749957|E2|Reported Event|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353159|NCT00749957|E1|Reported Event|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
353160|NCT00749944|B3|Baseline|Total|Total of all reporting groups
353161|NCT00749944|B2|Baseline|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353162|NCT00749944|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353163|NCT00749944|P2|Participant Flow|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353164|NCT00749944|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353165|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353166|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353167|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353168|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353169|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353170|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353171|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353172|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353173|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353174|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353175|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353176|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353177|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353178|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353179|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353180|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353181|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
355836|NCT00740792|P4|Participant Flow|Placebo|placebo control
353182|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353183|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353184|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353185|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353186|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353187|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353188|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353189|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353190|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353191|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353192|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353193|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353194|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353195|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353196|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353197|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353198|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353199|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353200|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353201|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353202|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353203|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353204|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353205|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353206|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353207|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353208|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353209|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353210|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353211|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
358048|NCT00734617|O2|Outcome|More Dependent|
353212|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353213|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353214|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353215|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353216|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353217|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353218|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353219|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353220|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353221|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353222|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353223|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353224|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353225|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353226|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353227|NCT00749944|E2|Reported Event|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
353228|NCT00749944|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
353229|NCT00749931|B3|Baseline|Total|Total of all reporting groups
353230|NCT00749931|B2|Baseline|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353231|NCT00749931|B1|Baseline|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
353232|NCT00749931|P3|Participant Flow|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353233|NCT00749931|P2|Participant Flow|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353234|NCT00749931|P1|Participant Flow|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
353235|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353236|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
353237|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353238|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
353239|NCT00749931|E3|Reported Event|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353240|NCT00749931|E2|Reported Event|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
353241|NCT00749931|E1|Reported Event|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
353242|NCT00749775|B1|Baseline|Selara|Participants taking Selara according to Japanese Package Insert.
353243|NCT00749775|P1|Participant Flow|Selara|Participants taking Selara according to Japanese Package Insert.
358049|NCT00734617|O1|Outcome|Less Dependent|
353244|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
353245|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
353246|NCT00749775|O4|Outcome|At 12 Weeks|Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
353247|NCT00749775|O3|Outcome|At 8 Weeks|Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
353248|NCT00749775|O2|Outcome|At 4 Weeks|Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
353249|NCT00749775|O1|Outcome|At Baseline|Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
353250|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
353251|NCT00749775|O4|Outcome|At 12 Weeks|Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
353252|NCT00749775|O3|Outcome|At 8 Weeks|Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
353253|NCT00749775|O2|Outcome|At 4 Weeks|Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
353254|NCT00749775|O1|Outcome|At Baseline|Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
353255|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
353256|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
353257|NCT00749775|E1|Reported Event|Selara|Participants taking Selara according to Japanese Package Insert.
353258|NCT00749684|B1|Baseline|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
353259|NCT00749684|P1|Participant Flow|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
353260|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
353261|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
353262|NCT00749684|E1|Reported Event|Interferon Alfa-2b|
353263|NCT00749671|B3|Baseline|Total|Total of all reporting groups
353264|NCT00749671|B2|Baseline|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
353265|NCT00749671|B1|Baseline|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
353266|NCT00749671|P2|Participant Flow|Ramsey Scale Monitoring|Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
353267|NCT00749671|P1|Participant Flow|Bispectral Index Monitoring|Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.
353268|NCT00749671|O2|Outcome|ICD Testing Ramsey|"Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
353269|NCT00749671|O1|Outcome|ICD Testing BIS|"Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.~Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
353270|NCT00749671|O2|Outcome|ICD testing2|"Ramsey Sedation Scale~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
353271|NCT00749671|O1|Outcome|ICD Testing|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
353272|NCT00749671|E2|Reported Event|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
353273|NCT00749671|E1|Reported Event|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
353274|NCT00749580|B3|Baseline|Total|Total of all reporting groups
353275|NCT00749580|B2|Baseline|2: Boosted PI+NRTIs|Group 2 Continue the same regimen without change
353276|NCT00749580|B1|Baseline|1: Boosted PI+RAL|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
353277|NCT00749580|P2|Participant Flow|Controlled|Group 2 Continue the same regimen without change
353278|NCT00749580|P1|Participant Flow|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
353279|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
353280|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
353281|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
353282|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
353283|NCT00749580|E2|Reported Event|Controlled|Group 2 Continue the same regimen without change
353284|NCT00749580|E1|Reported Event|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
353285|NCT00749476|B1|Baseline|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
353286|NCT00749476|P1|Participant Flow|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
353336|NCT00749268|B3|Baseline|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
353287|NCT00749476|O1|Outcome|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
353288|NCT00749476|E1|Reported Event|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
353289|NCT00749463|B4|Baseline|Total|Total of all reporting groups
353290|NCT00749463|B3|Baseline|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353291|NCT00749463|B2|Baseline|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353292|NCT00749463|B1|Baseline|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353293|NCT00749463|P3|Participant Flow|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353294|NCT00749463|P2|Participant Flow|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353295|NCT00749463|P1|Participant Flow|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353296|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353297|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353298|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353299|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353300|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353301|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353302|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353303|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353304|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353305|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353306|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353307|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353308|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353309|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353310|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353311|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353312|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353313|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353314|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353315|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353316|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353317|NCT00749463|E3|Reported Event|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
353318|NCT00749463|E2|Reported Event|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
353319|NCT00749463|E1|Reported Event|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
353320|NCT00749398|B1|Baseline|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353321|NCT00749398|P1|Participant Flow|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353322|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353323|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353324|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353325|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353326|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353327|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353328|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353329|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353330|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353331|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353332|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353333|NCT00749398|E1|Reported Event|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
353334|NCT00749268|B5|Baseline|Total|Total of all reporting groups
353335|NCT00749268|B4|Baseline|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
353337|NCT00749268|B2|Baseline|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353338|NCT00749268|B1|Baseline|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353339|NCT00749268|P2|Participant Flow|Ventral Arm|Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
353340|NCT00749268|P1|Participant Flow|Inguinal Arm|Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
353341|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
353342|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
353343|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353344|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353345|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
353346|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
353347|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353348|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353349|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
353350|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
353351|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353352|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353353|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
353354|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
353355|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353356|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353357|NCT00749268|E4|Reported Event|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
353358|NCT00749268|E3|Reported Event|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
353359|NCT00749268|E2|Reported Event|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
353360|NCT00749268|E1|Reported Event|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
353361|NCT00749190|B8|Baseline|Total|Total of all reporting groups
353362|NCT00749190|B7|Baseline|Sitag|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353363|NCT00749190|B6|Baseline|Empa 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353364|NCT00749190|B5|Baseline|Empa 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353365|NCT00749190|B4|Baseline|Empa 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353366|NCT00749190|B3|Baseline|Empa 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353367|NCT00749190|B2|Baseline|Empa 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353368|NCT00749190|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353369|NCT00749190|P7|Participant Flow|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353370|NCT00749190|P6|Participant Flow|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353371|NCT00749190|P5|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353372|NCT00749190|P4|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353373|NCT00749190|P3|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353374|NCT00749190|P2|Participant Flow|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353375|NCT00749190|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353376|NCT00749190|O5|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353377|NCT00749190|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353378|NCT00749190|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353379|NCT00749190|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353380|NCT00749190|O1|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353381|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353382|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353383|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353384|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353385|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353386|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353387|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353388|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353389|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353390|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353391|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353392|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353393|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353394|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353395|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353396|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353397|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353398|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353399|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353400|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353401|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353402|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353403|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353404|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353405|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353406|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353407|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353408|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353409|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353410|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353411|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353412|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353413|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353414|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353415|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353416|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353417|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353418|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353419|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353420|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353421|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353422|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353423|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353424|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353425|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353426|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353427|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353428|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353429|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353430|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353431|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353432|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353433|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353434|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353435|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353436|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353437|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353438|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353439|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353440|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353441|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353442|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353443|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353444|NCT00749190|E7|Reported Event|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
353445|NCT00749190|E6|Reported Event|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
353446|NCT00749190|E5|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
353447|NCT00749190|E4|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
353448|NCT00749190|E3|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
353449|NCT00749190|E2|Reported Event|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
353450|NCT00749190|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
353513|NCT00748865|B1|Baseline|Overall Study|
358050|NCT00734617|E2|Reported Event|More Dependent|
353451|NCT00749073|B1|Baseline|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
353452|NCT00749073|P1|Participant Flow|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
353453|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
353454|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. The mean change and standard deviation between baseline (pretreatment) and Month 6 are reported, where a positive value represents the baseline value minus the 6 month value.
353455|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
353456|NCT00749073|E1|Reported Event|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
353457|NCT00748982|B3|Baseline|Total|Total of all reporting groups
353458|NCT00748982|B2|Baseline|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353459|NCT00748982|B1|Baseline|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353460|NCT00748982|P2|Participant Flow|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353461|NCT00748982|P1|Participant Flow|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353462|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353463|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353464|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353465|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353466|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353467|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353468|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353469|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353470|NCT00748982|E2|Reported Event|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
353471|NCT00748982|E1|Reported Event|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
353472|NCT00748969|B3|Baseline|Total|Total of all reporting groups
353473|NCT00748969|B2|Baseline|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
353474|NCT00748969|B1|Baseline|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
353475|NCT00748969|P2|Participant Flow|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
353514|NCT00748865|P2|Participant Flow|Systane Drops, Then Systane Ultra Drops|Patients first received Systane Drops, then received Systane Ultra Drops
353476|NCT00748969|P1|Participant Flow|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
353477|NCT00748969|O2|Outcome|No Growth Hormone Treatment|Observation only: no growth hormone treatment and no placebo.
353478|NCT00748969|O1|Outcome|Growth Hormone Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
353479|NCT00748969|E2|Reported Event|No GH Treatment|No placebo/no treatment
353480|NCT00748969|E1|Reported Event|GH Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
353481|NCT00746512|B5|Baseline|Total|Total of all reporting groups
353482|NCT00746512|B4|Baseline|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353483|NCT00746512|B3|Baseline|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353484|NCT00746512|B2|Baseline|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
353485|NCT00746512|B1|Baseline|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
353486|NCT00746512|P4|Participant Flow|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353487|NCT00746512|P3|Participant Flow|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353488|NCT00746512|P2|Participant Flow|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
353489|NCT00746512|P1|Participant Flow|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
353490|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353491|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353492|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
353493|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
353494|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353495|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353496|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
353497|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
353498|NCT00746512|E4|Reported Event|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353499|NCT00746512|E3|Reported Event|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
353500|NCT00746512|E2|Reported Event|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
353501|NCT00746512|E1|Reported Event|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
353502|NCT00746421|B3|Baseline|Total|Total of all reporting groups
353503|NCT00746421|B2|Baseline|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
353504|NCT00746421|B1|Baseline|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
353505|NCT00746421|P2|Participant Flow|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
353506|NCT00746421|P1|Participant Flow|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
353507|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
353508|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
353509|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
353510|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
353511|NCT00746421|E2|Reported Event|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
353512|NCT00746421|E1|Reported Event|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
353515|NCT00748865|P1|Participant Flow|Systane Ultra Drops, Then Systane Drops|Patients received Systane Ultra Drops first, then received Systane Drops.
353516|NCT00748865|O2|Outcome|Systane|Systane
353517|NCT00748865|O1|Outcome|Systane Ultra|Systane Ultra
353518|NCT00748865|E2|Reported Event|Systane|Systane
353519|NCT00748865|E1|Reported Event|Systane Ultra|Systane Ultra
353520|NCT00748826|B1|Baseline|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353521|NCT00748826|P1|Participant Flow|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353522|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353523|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353524|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353525|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353526|NCT00748826|E1|Reported Event|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
353527|NCT00748709|B1|Baseline|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353528|NCT00748709|P1|Participant Flow|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353529|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353530|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353531|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353532|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353533|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353534|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353535|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353536|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353537|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353538|NCT00748709|E1|Reported Event|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
353539|NCT00748657|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353540|NCT00748657|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353541|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353542|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353543|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353544|NCT00748657|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
353545|NCT00748579|B3|Baseline|Total|Total of all reporting groups
353546|NCT00748579|B2|Baseline|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353547|NCT00748579|B1|Baseline|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353548|NCT00748579|P2|Participant Flow|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353549|NCT00748579|P1|Participant Flow|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353550|NCT00748579|O2|Outcome|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353551|NCT00748579|O1|Outcome|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353552|NCT00748579|E2|Reported Event|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353553|NCT00748579|E1|Reported Event|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
353554|NCT00748566|B1|Baseline|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353555|NCT00748566|P1|Participant Flow|Ziprasidone|Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353556|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353557|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353558|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353559|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353560|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353561|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353562|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353563|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353564|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353565|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353566|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353567|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353568|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353614|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353569|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353570|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353571|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353572|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353573|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353574|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353575|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353576|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353577|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353578|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353579|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353580|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353581|NCT00748566|E1|Reported Event|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
353582|NCT00748241|B1|Baseline|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353583|NCT00748241|P1|Participant Flow|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353584|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353585|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353586|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353587|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353588|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353589|NCT00748241|E1|Reported Event|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
353590|NCT00748189|B3|Baseline|Total|Total of all reporting groups
353591|NCT00748189|B2|Baseline|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353592|NCT00748189|B1|Baseline|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353593|NCT00748189|P2|Participant Flow|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353665|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353666|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353594|NCT00748189|P1|Participant Flow|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353595|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353596|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353597|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353598|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353599|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353600|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353601|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353602|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353603|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353604|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353605|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353606|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353607|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353608|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353609|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
353610|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353611|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
353612|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353613|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353667|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
358051|NCT00734617|E1|Reported Event|Less Dependent|
353615|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353616|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353617|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353618|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353619|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353620|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353621|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353622|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
353623|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353624|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353625|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353626|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353627|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353628|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353629|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353630|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353631|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353632|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353633|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353634|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353635|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
358052|NCT00734604|B7|Baseline|Total|Total of all reporting groups
353636|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353637|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353638|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353639|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353640|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353641|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353642|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353643|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353644|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353645|NCT00748189|E2|Reported Event|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353646|NCT00748189|E1|Reported Event|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
353647|NCT00748098|B1|Baseline|All Participants in the Intent-to-Treat (ITT) Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment
353648|NCT00748098|P2|Participant Flow|GEn 1200 mg/Day Followed by Placebo|Participants randomized to GEn 1200 mg/day administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day First Taper Period. No treatment was given during 7-day Washout. Matching placebo administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period and the 7-day Second Taper Period. No treatment was given during Follow-up.
353649|NCT00748098|P1|Participant Flow|Placebo Followed by GEn 1200 mg/Day|Participants randomized to matching placebo administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period and the 7-day First Taper Period. No treatment was given during the 7-day Washout. Gabapentin enacarbil (GEn) 1200 mg/day administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day Second Taper Period. No treatment was given during Follow-up.
353650|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353651|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353652|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353653|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
353654|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353655|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353656|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353657|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353658|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353659|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
353660|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353661|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353662|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353663|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353664|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353668|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353669|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353670|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353671|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353672|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353673|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353674|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353675|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353676|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353677|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353678|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353679|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
353680|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353681|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353682|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353683|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353684|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353685|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353686|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353687|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353688|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353689|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353690|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353691|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353692|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353693|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353694|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353695|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353696|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353697|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353698|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353699|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353700|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353701|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353702|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353703|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353704|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
353705|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
353706|NCT00748098|E2|Reported Event|GEn 1200 mg|Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg.
353707|NCT00748098|E1|Reported Event|Placebo|Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo.
353708|NCT00748085|B1|Baseline|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
353743|NCT00746330|B4|Baseline|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353709|NCT00748085|P1|Participant Flow|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
353710|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
353711|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
353712|NCT00748085|E1|Reported Event|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
353713|NCT00748072|B3|Baseline|Total|Total of all reporting groups
353714|NCT00748072|B2|Baseline|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
353715|NCT00748072|B1|Baseline|Saline Solution|patients treated with 1 ml of s.c. saline solution
353716|NCT00748072|P2|Participant Flow|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
353717|NCT00748072|P1|Participant Flow|Saline Solution|patients treated with 1 ml of s.c. saline solution
353718|NCT00748072|O2|Outcome|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
353719|NCT00748072|O1|Outcome|Saline Solution|patients treated with 1 ml of s.c. saline solution
353720|NCT00748072|E2|Reported Event|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
353721|NCT00748072|E1|Reported Event|Saline Solution|patients treated with 1 ml of s.c. saline solution
353722|NCT00746395|B3|Baseline|Total|Total of all reporting groups
353723|NCT00746395|B2|Baseline|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
353724|NCT00746395|B1|Baseline|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
353725|NCT00746395|P2|Participant Flow|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
353726|NCT00746395|P1|Participant Flow|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
353727|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
353728|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
353729|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
353730|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
353731|NCT00746395|E2|Reported Event|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
353732|NCT00746395|E1|Reported Event|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
353733|NCT00746356|B1|Baseline|All Patients|All patients enrolled in the study
353734|NCT00746356|P2|Participant Flow|ICD Device Patients|All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
353735|NCT00746356|P1|Participant Flow|CRT-D Device Patients|All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
353736|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.
353737|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle
353738|NCT00746356|O1|Outcome|Participants With Single or Dual Chamber ICDs|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle
353739|NCT00746356|O1|Outcome|Participants With Dual Chamber ICDs or CRTD Devices|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold
353740|NCT00746356|O1|Outcome|Participants Successfully Implanted With Devices|All participants successfully implanted with an ICD or CRT-D
353741|NCT00746356|E1|Reported Event|All Patients|All patients enrolled in the study
353742|NCT00746330|B5|Baseline|Total|Total of all reporting groups
353744|NCT00746330|B3|Baseline|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353745|NCT00746330|B2|Baseline|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353746|NCT00746330|B1|Baseline|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353747|NCT00746330|P4|Participant Flow|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353748|NCT00746330|P3|Participant Flow|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353749|NCT00746330|P2|Participant Flow|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353750|NCT00746330|P1|Participant Flow|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via Pressurized Metered Dose Inhaler (pMDI) + placebo to formoterol fumarate via Dry Powder Inhaler (DPI); Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
353751|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
353752|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353753|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353754|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
353755|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353756|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353757|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
353758|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
353759|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353760|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353761|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
353762|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
353763|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353764|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353765|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
353766|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
353767|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353768|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353770|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
353771|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
353772|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353773|NCT00746330|E4|Reported Event|Placebo|Placebo via pMDI/ Placebo via DPI
353774|NCT00746330|E3|Reported Event|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
353775|NCT00746330|E2|Reported Event|F12D|Placebo Via pMDI/ Formoterol Fumarate 12 μg Via DPI
353776|NCT00746330|E1|Reported Event|F12M|Formoterol Fumarate 12 μg Via pMDI/ Placebo Via DPI
353777|NCT00747916|B1|Baseline|All Participants ICE PLS|
353778|NCT00747916|P1|Participant Flow|All Participants ICE PLS|The study consists of one arm. All subjects enrolled in All participants ICE PLS
353779|NCT00747916|O1|Outcome|All Participants ICE PLS|
353780|NCT00747916|O1|Outcome|All Participants ICE PLS|
353781|NCT00747916|E1|Reported Event|All Participants ICE PLS|
353782|NCT00747812|B3|Baseline|Total|Total of all reporting groups
353783|NCT00747812|B2|Baseline|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
353784|NCT00747812|B1|Baseline|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
353785|NCT00747812|P2|Participant Flow|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
353786|NCT00747812|P1|Participant Flow|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
353787|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
353788|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
353789|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
353790|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
353791|NCT00747812|E2|Reported Event|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
353792|NCT00747812|E1|Reported Event|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
353793|NCT00747747|B4|Baseline|Total|Total of all reporting groups
353794|NCT00747747|B3|Baseline|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
353795|NCT00747747|B2|Baseline|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
353796|NCT00747747|B1|Baseline|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353797|NCT00747747|P3|Participant Flow|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
353798|NCT00747747|P2|Participant Flow|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
353799|NCT00747747|P1|Participant Flow|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353800|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353801|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353802|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353803|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353804|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353805|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353806|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353807|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353808|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353809|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353810|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353811|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353812|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353813|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353814|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353815|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353816|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353817|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353818|NCT00747747|E3|Reported Event|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
353819|NCT00747747|E2|Reported Event|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
353820|NCT00747747|E1|Reported Event|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
353821|NCT00747643|B3|Baseline|Total|Total of all reporting groups
353822|NCT00747643|B2|Baseline|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353823|NCT00747643|B1|Baseline|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353824|NCT00747643|P2|Participant Flow|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353825|NCT00747643|P1|Participant Flow|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353826|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353827|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353828|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353829|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353830|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353831|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353832|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353833|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353834|NCT00747643|E2|Reported Event|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
353835|NCT00747643|E1|Reported Event|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
353836|NCT00747617|B3|Baseline|Total|Total of all reporting groups
353837|NCT00747617|B2|Baseline|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353838|NCT00747617|B1|Baseline|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353839|NCT00747617|P2|Participant Flow|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353840|NCT00747617|P1|Participant Flow|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353841|NCT00747617|O2|Outcome|Normal|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
353842|NCT00747617|O1|Outcome|PCOS|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
353843|NCT00747617|E2|Reported Event|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353844|NCT00747617|E1|Reported Event|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
353845|NCT00747565|B3|Baseline|Total|Total of all reporting groups
353846|NCT00747565|B2|Baseline|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
353847|NCT00747565|B1|Baseline|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
353848|NCT00747565|P2|Participant Flow|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
353849|NCT00747565|P1|Participant Flow|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
353850|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
353851|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
353852|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
353957|NCT00747149|P2|Participant Flow|Rosuvastatin Non-titrated|10 mg RSV or 20 mg RSV
353853|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
353854|NCT00747565|E2|Reported Event|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
353855|NCT00747565|E1|Reported Event|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.
353856|NCT00747552|B1|Baseline|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
353857|NCT00747552|P1|Participant Flow|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
353858|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
353859|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
353860|NCT00747552|E1|Reported Event|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
353861|NCT00747474|B1|Baseline|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353862|NCT00747474|P12|Participant Flow|Cohort 12 (60 mg/m^2)|Participants received 60 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353863|NCT00747474|P11|Participant Flow|Cohort 11 (50 mg/m^2)|Participants received 50 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353864|NCT00747474|P10|Participant Flow|Cohort 10 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353865|NCT00747474|P9|Participant Flow|Cohort 9 (35 mg/m^2)|Participants received 35 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353866|NCT00747474|P8|Participant Flow|Cohort 8 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353867|NCT00747474|P7|Participant Flow|Cohort 7 (30 mg/m^2)|Participants received 30 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353868|NCT00747474|P6|Participant Flow|Cohort 6 (20 mg/m^2)|Participants received 20 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353869|NCT00747474|P5|Participant Flow|Cohort 5 (13.5 mg/m^2)|Participants received 13.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353870|NCT00747474|P4|Participant Flow|Cohort 4 (9 mg/m^2)|Participants received 9 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353871|NCT00747474|P3|Participant Flow|Cohort 3 (6 mg/m^2)|Participants received 6 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353872|NCT00747474|P2|Participant Flow|Cohort 2 (3 mg/m^2)|Participants received 3 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353873|NCT00747474|P1|Participant Flow|Cohort 1 (1.5 mg/m^2)|Participants received 1.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
353874|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353875|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353876|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353877|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353878|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353879|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353880|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353881|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353882|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353883|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353884|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353885|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353886|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353887|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353888|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353889|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353890|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353891|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353892|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353893|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353894|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353895|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353896|NCT00747474|O1|Outcome|All Participants|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle according to the dose assigned.
353897|NCT00747474|E1|Reported Event|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
353898|NCT00747461|B1|Baseline|Cryo Spray Ablation|subjects will receive up to 4 -5 second cycles of cryospray ablation
353899|NCT00747461|P1|Participant Flow|Cryo Spray Ablation|subjects receiving up to 4 -5 second spray cycles
353900|NCT00747461|O1|Outcome|Cryo Spray Ablation|subjects receiving cryo spray ablation
353901|NCT00747461|O1|Outcome|Cryo Spray Ablation|Subject receiving cryo spray ablation
353902|NCT00747461|E1|Reported Event|All Subjects Receiving CSA Cryospray|"All subjects enrolled will received CSA cryospray.~CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system."
353903|NCT00747344|B3|Baseline|Total|Total of all reporting groups
353904|NCT00747344|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
353905|NCT00747344|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
353906|NCT00747344|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
353907|NCT00747344|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
353908|NCT00747344|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
353909|NCT00747344|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
353910|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
353911|NCT00747344|O1|Outcome|Placebo|
353912|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
353913|NCT00747344|O1|Outcome|Placebo|
353914|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
353915|NCT00747344|O1|Outcome|Placebo|
353916|NCT00747344|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
353917|NCT00747344|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
353918|NCT00747344|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
353919|NCT00747344|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
353920|NCT00746239|B1|Baseline|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
353921|NCT00746239|P1|Participant Flow|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
353922|NCT00746239|O1|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
353923|NCT00746239|E1|Reported Event|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|"Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record.~Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)"
353924|NCT00747227|B3|Baseline|Total|Total of all reporting groups
353925|NCT00747227|B2|Baseline|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353926|NCT00747227|B1|Baseline|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353927|NCT00747227|P2|Participant Flow|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353928|NCT00747227|P1|Participant Flow|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353929|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353930|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353931|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353932|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353933|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353934|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353935|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353936|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353937|NCT00747227|E2|Reported Event|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
353938|NCT00747227|E1|Reported Event|ZV9003 Intraocular Lens|modified light transmission intraocular lens
353939|NCT00747214|B3|Baseline|Total|Total of all reporting groups
353940|NCT00747214|B2|Baseline|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353941|NCT00747214|B1|Baseline|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353942|NCT00747214|P2|Participant Flow|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353943|NCT00747214|P1|Participant Flow|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)~Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353944|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353945|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353946|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353947|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353948|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353949|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353950|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353951|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
353952|NCT00747214|E2|Reported Event|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
353953|NCT00747214|E1|Reported Event|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent"
353954|NCT00747149|B3|Baseline|Total|Total of all reporting groups
353955|NCT00747149|B2|Baseline|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
353956|NCT00747149|B1|Baseline|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
353994|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
353958|NCT00747149|P1|Participant Flow|Rosuvastatin Titrated|10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
353959|NCT00747149|O4|Outcome|Rosuvastatin 40 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
353960|NCT00747149|O3|Outcome|Rosuvastatin 20 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
353961|NCT00747149|O2|Outcome|Rosuvastatin 20 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
353962|NCT00747149|O1|Outcome|Rosuvastatin 10 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
353963|NCT00747149|E6|Reported Event|Rosuvastatin 40 mg (Titrated)|20 mg RSV as titrated dose
353964|NCT00747149|E5|Reported Event|Rosuvastatin 20 mg (Titrated)|20 mg RSV as titrated dose
353965|NCT00747149|E4|Reported Event|Rosuvastatin 20 mg (Continued, Non-titrated)|20 mg RSV as continued, non-titrated dose
353966|NCT00747149|E3|Reported Event|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
353967|NCT00747149|E2|Reported Event|Rosuvastatin 10 mg (Continued, Non-titrated)|10 mg RSV as a continued, non-titrated dose
353968|NCT00747149|E1|Reported Event|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
353969|NCT00747006|B4|Baseline|Total|Total of all reporting groups
353970|NCT00747006|B3|Baseline|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353971|NCT00747006|B2|Baseline|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353972|NCT00747006|B1|Baseline|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353973|NCT00747006|P3|Participant Flow|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353974|NCT00747006|P2|Participant Flow|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353975|NCT00747006|P1|Participant Flow|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
353976|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
353977|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
353978|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
353979|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
353980|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
353981|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
353982|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
353983|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
353984|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
353985|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
353986|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
353987|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
353988|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
353989|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
353990|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
353991|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
353992|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
353993|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
353995|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
353996|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
353997|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
353998|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
353999|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354000|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354001|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354002|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354003|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354004|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354005|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354006|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354007|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354008|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354009|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354010|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354011|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354012|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354013|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354014|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354015|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354016|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354017|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354018|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354019|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354020|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354021|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354022|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354023|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354024|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354025|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354026|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354027|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354028|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354029|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354030|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354031|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
354032|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
354033|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
354034|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
354035|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
354036|NCT00747006|E4|Reported Event|Humalog Amendment 1 Type 2 DM|Humalog treated subjects in protocol amendment 1
354037|NCT00747006|E3|Reported Event|TI Amendment 1 Type 2 DM|Technosphere Insulin treated subjects in protocol amendment 1
354038|NCT00747006|E2|Reported Event|TI Original Protocol Type 2 DM|Original protocol type 2 diabetes mellitus subjects
354039|NCT00747006|E1|Reported Event|TI Original Protocol Type 1 DM|Original protocol type 1 diabetes mellitus subjects
354040|NCT00746954|B1|Baseline|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
354041|NCT00746954|P3|Participant Flow|Arm 3 BUS to ACET to PLA|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
354042|NCT00746954|P2|Participant Flow|Arm 2 Acet to Placebo to Bus|Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),
354043|NCT00746954|P1|Participant Flow|Arm 1 Control to ACET to BUS|Each patient will act as their own control, with comparisons over three nights, this is placebo
354044|NCT00746954|O3|Outcome|PLACEBO|Each patient will act as their own control, with comparisons over three nights
354045|NCT00746954|O2|Outcome|ACETAZOLAMIDE|Each patient will act as their own control, with comparisons over three nights
354046|NCT00746954|O1|Outcome|BUSPIRONE|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
354047|NCT00746954|E1|Reported Event|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
354048|NCT00746941|B5|Baseline|Total|Total of all reporting groups
354203|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
354049|NCT00746941|B4|Baseline|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354050|NCT00746941|B3|Baseline|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
354051|NCT00746941|B2|Baseline|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
354052|NCT00746941|B1|Baseline|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
354053|NCT00746941|P4|Participant Flow|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354054|NCT00746941|P3|Participant Flow|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
354055|NCT00746941|P2|Participant Flow|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
354056|NCT00746941|P1|Participant Flow|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
354057|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|"Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.~Also includes participants who were randomized to receive local standard of care (only) and added mefloquine at Week 4 or Week 8."
354058|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354059|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354060|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354061|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354062|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354063|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354064|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354065|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354066|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354067|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354204|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354205|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354068|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354069|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354070|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354071|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354072|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354073|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354074|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354075|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354076|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
354077|NCT00746941|E4|Reported Event|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
354078|NCT00746941|E3|Reported Event|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
354079|NCT00746941|E2|Reported Event|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
354080|NCT00746941|E1|Reported Event|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment."
354081|NCT00746889|B3|Baseline|Total|Total of all reporting groups
354082|NCT00746889|B2|Baseline|Placebo|Intraarticular injection of 0.9% saline
354083|NCT00746889|B1|Baseline|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
354084|NCT00746889|P2|Participant Flow|Placebo|Intraarticular injection of 0.9% saline
354085|NCT00746889|P1|Participant Flow|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
354086|NCT00746889|O2|Outcome|Noninflammatory Patients Who Received Corticosteroid Injection|Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
354087|NCT00746889|O1|Outcome|Inflammatory Patients Who Received Corticosteroid Injections|Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
354088|NCT00746889|O2|Outcome|Placebo|Intraarticular injection of 0.9% saline
354089|NCT00746889|O1|Outcome|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
354090|NCT00746889|E2|Reported Event|Placebo|Intraarticular injection of 0.9% saline
354091|NCT00746889|E1|Reported Event|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
354092|NCT00746863|B3|Baseline|Total|Total of all reporting groups
354093|NCT00746863|B2|Baseline|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354094|NCT00746863|B1|Baseline|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354095|NCT00746863|P2|Participant Flow|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354096|NCT00746863|P1|Participant Flow|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354097|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354098|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354099|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354100|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354101|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354102|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354103|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354104|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354105|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354106|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354107|NCT00746863|E2|Reported Event|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
354108|NCT00746863|E1|Reported Event|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
354109|NCT00746798|B5|Baseline|Total|Total of all reporting groups
354110|NCT00746798|B4|Baseline|Placebo|Participants who received placebo (saline) given one time subcutaneously
354111|NCT00746798|B3|Baseline|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354112|NCT00746798|B2|Baseline|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354113|NCT00746798|B1|Baseline|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354114|NCT00746798|P4|Participant Flow|Placebo|Participants who received placebo (saline) given one time subcutaneously
354115|NCT00746798|P3|Participant Flow|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354116|NCT00746798|P2|Participant Flow|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354117|NCT00746798|P1|Participant Flow|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354118|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
354119|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354120|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354121|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354122|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
354123|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354124|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354125|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354126|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
354127|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354206|NCT00746733|O2|Outcome|Adderall XR|
354207|NCT00746733|O1|Outcome|Vyvanse|
354128|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354129|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354130|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
354131|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354132|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354133|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354134|NCT00746798|E4|Reported Event|Placebo|Participants who received placebo (saline) given one time subcutaneously
354135|NCT00746798|E3|Reported Event|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
354136|NCT00746798|E2|Reported Event|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
354137|NCT00746798|E1|Reported Event|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
354138|NCT00746785|B4|Baseline|Total|Total of all reporting groups
354139|NCT00746785|B3|Baseline|C - Placebo|placebo : placebo
354140|NCT00746785|B2|Baseline|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
354141|NCT00746785|B1|Baseline|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
354142|NCT00746785|P3|Participant Flow|C - Placebo|placebo : placebo
354143|NCT00746785|P2|Participant Flow|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
354144|NCT00746785|P1|Participant Flow|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
354145|NCT00746785|O3|Outcome|C - Placebo|placebo : placebo
354146|NCT00746785|O2|Outcome|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
354147|NCT00746785|O1|Outcome|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
354148|NCT00746785|E3|Reported Event|C - Placebo|placebo : placebo
354149|NCT00746785|E2|Reported Event|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
354150|NCT00746785|E1|Reported Event|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
354151|NCT00746733|B1|Baseline|Entire Study Population|
354152|NCT00746733|P2|Participant Flow|Adderall XR First|Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
354153|NCT00746733|P1|Participant Flow|Vyvanse First|Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
354154|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354155|NCT00746733|O1|Outcome|Adderall XR|
354156|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354157|NCT00746733|O1|Outcome|Adderall XR|
354158|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354159|NCT00746733|O1|Outcome|Adderall XR|
354160|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354161|NCT00746733|O1|Outcome|Adderall XR|
354162|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354163|NCT00746733|O1|Outcome|Adderall XR|
354164|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354165|NCT00746733|O1|Outcome|Adderall XR|
354166|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354167|NCT00746733|O1|Outcome|Adderall XR|
354168|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354169|NCT00746733|O1|Outcome|Adderall XR|
354170|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354171|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354172|NCT00746733|O2|Outcome|Adderall XR|
354173|NCT00746733|O1|Outcome|Vyvanse|
354174|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354175|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354176|NCT00746733|O2|Outcome|Adderall XR|
354177|NCT00746733|O1|Outcome|Vyvanse|
354178|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354179|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354180|NCT00746733|O2|Outcome|Adderall XR|
354181|NCT00746733|O1|Outcome|Vyvanse|
354182|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354183|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354184|NCT00746733|O2|Outcome|Adderall XR|
354185|NCT00746733|O1|Outcome|Vyvanse|
354186|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354187|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354188|NCT00746733|O2|Outcome|Adderall XR|
354189|NCT00746733|O1|Outcome|Vyvanse|
354190|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354191|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354192|NCT00746733|O2|Outcome|Adderall XR|
354193|NCT00746733|O1|Outcome|Vyvanse|
354194|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
354195|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
354196|NCT00746733|O2|Outcome|Adderall XR|
354197|NCT00746733|O1|Outcome|Vyvanse|
354198|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354199|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
354200|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354201|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
354202|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
354212|NCT00746694|B1|Baseline|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
354213|NCT00746694|P1|Participant Flow|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
354214|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
354215|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
354216|NCT00746694|E1|Reported Event|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
354217|NCT00746668|B1|Baseline|All Study Participants|All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test.
354218|NCT00746668|P7|Participant Flow|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
354219|NCT00746668|P6|Participant Flow|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
354220|NCT00746668|P5|Participant Flow|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
354221|NCT00746668|P4|Participant Flow|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
354222|NCT00746668|P3|Participant Flow|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
354223|NCT00746668|P2|Participant Flow|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
354224|NCT00746668|P1|Participant Flow|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
354225|NCT00746668|O4|Outcome|Arm 4: Assessment After Module 3|Assessment after six-weeks of training in Module 3 (RSVP Reading).
354226|NCT00746668|O3|Outcome|Arm 3: Assessment After Module 2|Assessment after six-weeks of training in Module 2 (Eye Movement Training).
354227|NCT00746668|O2|Outcome|Arm 2: Assessment After Module 1|Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
354228|NCT00746668|O1|Outcome|Arm 1: Pre-Training|Baseline Assessment prior to training.
354229|NCT00746668|E7|Reported Event|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
354278|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
354230|NCT00746668|E6|Reported Event|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
354231|NCT00746668|E5|Reported Event|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
354232|NCT00746668|E4|Reported Event|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
354233|NCT00746668|E3|Reported Event|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
354234|NCT00746668|E2|Reported Event|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
354235|NCT00746668|E1|Reported Event|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
354236|NCT00746590|B1|Baseline|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
354237|NCT00746590|P1|Participant Flow|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
354238|NCT00746590|O1|Outcome|Prolarix Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
354239|NCT00746590|E1|Reported Event|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
354240|NCT00746564|B1|Baseline|Open Label|All patients who were implanted with the SJM Confirm device.
354241|NCT00746564|P1|Participant Flow|SJM Confirm Device|All patients in this study received the St. Jude Medical (SJM Confirm device.
354242|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with the SJM Confirm device.
354243|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
354244|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
354245|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354246|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354247|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354248|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354249|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354250|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354251|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354252|NCT00746564|E1|Reported Event|SJM Confirm Device|All patients in this study received the SJM Confirm device.
354253|NCT00746551|B3|Baseline|Total|Total of all reporting groups
354254|NCT00746551|B2|Baseline|Ferrous Fumarate, Ferri-6, Oral Tablet|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
354277|NCT00746096|P1|Participant Flow|IKH-01|"Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
354255|NCT00746551|B1|Baseline|Iron Sucrose, Venofer, Intravenous Drug|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
354256|NCT00746551|P2|Participant Flow|Ferrous Fumarate, Ferri-6®, Oral Tablet|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
354257|NCT00746551|P1|Participant Flow|Iron Sucrose, Venofer®, Intravenous Drug|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
354258|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
354259|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
354260|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
354261|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
354262|NCT00746551|E2|Reported Event|Ferrous Fumarate, Ferri-6®, Oral Tablet|Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
354263|NCT00746551|E1|Reported Event|Iron Sucrose, Venofer®, Intravenous Drug|"In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
354264|NCT00746187|B3|Baseline|Total|Total of all reporting groups
354265|NCT00746187|B2|Baseline|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
354266|NCT00746187|B1|Baseline|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
354267|NCT00746187|P2|Participant Flow|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
354268|NCT00746187|P1|Participant Flow|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
354269|NCT00746187|O2|Outcome|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
354270|NCT00746187|O1|Outcome|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
354271|NCT00746187|E2|Reported Event|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
354272|NCT00746187|E1|Reported Event|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
354273|NCT00746096|B3|Baseline|Total|Total of all reporting groups
354274|NCT00746096|B2|Baseline|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
354275|NCT00746096|B1|Baseline|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
354276|NCT00746096|P2|Participant Flow|Placebo|"Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
354279|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
354280|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
354281|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
354282|NCT00746096|E2|Reported Event|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
354283|NCT00746096|E1|Reported Event|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
354284|NCT00745940|B3|Baseline|Total|Total of all reporting groups
354285|NCT00745940|B2|Baseline|MBCT Control Group|Control group waited.
354286|NCT00745940|B1|Baseline|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354287|NCT00745940|P2|Participant Flow|MBCT Control Group|Control group waited.
354288|NCT00745940|P1|Participant Flow|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354289|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
354290|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354291|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
354292|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354293|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
354294|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354295|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
354296|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354297|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
354298|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354299|NCT00745940|E2|Reported Event|MBCT Control Group|Control group waited.
354336|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354337|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354300|NCT00745940|E1|Reported Event|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
354301|NCT00745901|B3|Baseline|Total|Total of all reporting groups
354302|NCT00745901|B2|Baseline|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354303|NCT00745901|B1|Baseline|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354304|NCT00745901|P2|Participant Flow|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354305|NCT00745901|P1|Participant Flow|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354306|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354307|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354308|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354309|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354310|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354311|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354312|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354313|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354314|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354315|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354316|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354317|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354318|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354319|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354320|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354321|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354322|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354323|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354324|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354325|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354326|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354327|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354328|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354329|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354330|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354331|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354332|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354333|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354334|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354335|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354338|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354339|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354340|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354341|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354342|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354343|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354344|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354345|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354346|NCT00745901|E2|Reported Event|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
354347|NCT00745901|E1|Reported Event|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
354348|NCT00745875|B3|Baseline|Total|Total of all reporting groups
354349|NCT00745875|B2|Baseline|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
354350|NCT00745875|B1|Baseline|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
354351|NCT00745875|P2|Participant Flow|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
354352|NCT00745875|P1|Participant Flow|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
354353|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
354354|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
354355|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
354356|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
354357|NCT00745875|E2|Reported Event|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
354358|NCT00745875|E1|Reported Event|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
354359|NCT00745823|B3|Baseline|Total|Total of all reporting groups
354360|NCT00745823|B2|Baseline|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354361|NCT00745823|B1|Baseline|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354362|NCT00745823|P2|Participant Flow|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354363|NCT00745823|P1|Participant Flow|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354364|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354365|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354366|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354367|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354368|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg b.i.d. administered with TRUVADA™
354369|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
354370|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354371|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354372|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354373|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354374|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354375|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354376|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354377|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354378|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354458|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354379|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354380|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354381|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354382|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354383|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354384|NCT00745823|E2|Reported Event|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
354385|NCT00745823|E1|Reported Event|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
354386|NCT00745498|B4|Baseline|Total|Total of all reporting groups
354387|NCT00745498|B3|Baseline|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354388|NCT00745498|B2|Baseline|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354389|NCT00745498|B1|Baseline|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354390|NCT00745498|P3|Participant Flow|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354391|NCT00745498|P2|Participant Flow|Introp IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354392|NCT00745498|P1|Participant Flow|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354393|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354394|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354395|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354396|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354397|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354398|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354399|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354400|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354401|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354402|NCT00745498|E3|Reported Event|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
354403|NCT00745498|E2|Reported Event|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
354404|NCT00745498|E1|Reported Event|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
354405|NCT00744380|B3|Baseline|Total|Total of all reporting groups
354406|NCT00744380|B2|Baseline|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354407|NCT00744380|B1|Baseline|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354408|NCT00744380|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354409|NCT00744380|P1|Participant Flow|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354410|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354459|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354488|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354411|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354412|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354413|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354414|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354415|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354416|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354417|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354418|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354419|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354420|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354421|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354422|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354423|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354485|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354486|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354487|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354424|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354425|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354426|NCT00744380|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354427|NCT00744380|E1|Reported Event|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
354428|NCT00744328|B4|Baseline|Total|Total of all reporting groups
354429|NCT00744328|B3|Baseline|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
354430|NCT00744328|B2|Baseline|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
354431|NCT00744328|B1|Baseline|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
354432|NCT00744328|P3|Participant Flow|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
354433|NCT00744328|P2|Participant Flow|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
354434|NCT00744328|P1|Participant Flow|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
354435|NCT00744328|O3|Outcome|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
354436|NCT00744328|O2|Outcome|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
354437|NCT00744328|O1|Outcome|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
354438|NCT00744328|E3|Reported Event|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
354439|NCT00744328|E2|Reported Event|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
354440|NCT00744328|E1|Reported Event|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
354441|NCT00744263|B3|Baseline|Total|Total of all reporting groups
354442|NCT00744263|B2|Baseline|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354443|NCT00744263|B1|Baseline|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354444|NCT00744263|P2|Participant Flow|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354445|NCT00744263|P1|Participant Flow|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354446|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354447|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354448|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354449|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354450|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354451|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354452|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354453|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354454|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354455|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354456|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
354457|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
354460|NCT00744263|E4|Reported Event|Placebo Immunogenicity Subset|Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
354461|NCT00744263|E3|Reported Event|13vPnC Immunogenicity Subset|Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
354462|NCT00744263|E2|Reported Event|Placebo Safety Set|All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
354463|NCT00744263|E1|Reported Event|13vPnC Safety Set|All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
354464|NCT00744237|B4|Baseline|Total|Total of all reporting groups
354465|NCT00744237|B3|Baseline|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
354466|NCT00744237|B2|Baseline|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
354467|NCT00744237|B1|Baseline|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
354468|NCT00744237|P3|Participant Flow|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
354469|NCT00744237|P2|Participant Flow|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
354470|NCT00744237|P1|Participant Flow|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
354471|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
354472|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
354473|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
354474|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
354475|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
354476|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
354477|NCT00744237|E3|Reported Event|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
354478|NCT00744237|E2|Reported Event|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
354479|NCT00744237|E1|Reported Event|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
354480|NCT00745368|B1|Baseline|Raltegravir|Raltegravir 400 mg tablets twice daily
354481|NCT00745368|P1|Participant Flow|Raltegravir|Raltegravir 400 mg tablets twice daily
354482|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354483|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354484|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354489|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
354490|NCT00745368|E1|Reported Event|Raltegravir|Raltegravir 400 mg tablets twice daily
354491|NCT00745290|B3|Baseline|Total|Total of all reporting groups
354492|NCT00745290|B2|Baseline|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
354493|NCT00745290|B1|Baseline|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
354494|NCT00745290|P2|Participant Flow|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
354495|NCT00745290|P1|Participant Flow|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
354496|NCT00745290|O2|Outcome|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
354497|NCT00745290|O1|Outcome|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
354498|NCT00745290|E2|Reported Event|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
354499|NCT00745290|E1|Reported Event|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
354500|NCT00745251|B3|Baseline|Total|Total of all reporting groups
354501|NCT00745251|B2|Baseline|Top Dose|PHEN/TPM 15mg/92mg
354502|NCT00745251|B1|Baseline|Placebo|
354503|NCT00745251|P2|Participant Flow|Top Dose|PHEN/TPM 15mg/92mg
354504|NCT00745251|P1|Participant Flow|Placebo|
354505|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
354506|NCT00745251|O1|Outcome|Placebo|
354507|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
354508|NCT00745251|O1|Outcome|Placebo|
354509|NCT00745251|E2|Reported Event|Top Dose|PHEN/TPM 15mg/92mg
354510|NCT00745251|E1|Reported Event|Placebo|
354511|NCT00745095|B7|Baseline|Total|Total of all reporting groups
354512|NCT00745095|B6|Baseline|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
354513|NCT00745095|B5|Baseline|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
354514|NCT00745095|B4|Baseline|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354515|NCT00745095|B3|Baseline|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
354516|NCT00745095|B2|Baseline|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354517|NCT00745095|B1|Baseline|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
354518|NCT00745095|P6|Participant Flow|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
354519|NCT00745095|P5|Participant Flow|Control MoviPrep® Only|(Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG])
354520|NCT00745095|P4|Participant Flow|SCI PIEE (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354521|NCT00745095|P3|Participant Flow|SCI PIEE (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG])
354522|NCT00745095|P2|Participant Flow|SCI MoviPrep® (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354523|NCT00745095|P1|Participant Flow|SCI MoviPrep® (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
354524|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
354525|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
354526|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354527|NCT00745095|O3|Outcome|SCI PIEE ( Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
354528|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354529|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)
354530|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
354531|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
354532|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354533|NCT00745095|O3|Outcome|SCI PIEE (Without NG)|"(SCI, GFR>=50ml/min) PIEE (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354534|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354535|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)
354536|NCT00745095|E6|Reported Event|SCI PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
354537|NCT00745095|E5|Reported Event|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
354538|NCT00745095|E4|Reported Event|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354539|NCT00745095|E3|Reported Event|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
354540|NCT00745095|E2|Reported Event|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
354541|NCT00745095|E1|Reported Event|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)
354542|NCT00745030|B3|Baseline|Total|Total of all reporting groups
354543|NCT00745030|B2|Baseline|Placebo 8 mg Tablets|Placebo 8 mg tablets
354544|NCT00745030|B1|Baseline|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
354545|NCT00745030|P2|Participant Flow|Placebo 8 mg Tablets|Placebo 8 mg tablets
354546|NCT00745030|P1|Participant Flow|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
354547|NCT00745030|O2|Outcome|Placebo 8 mg Tablets|Placebo 8 mg tablets
354548|NCT00745030|O1|Outcome|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
354549|NCT00745030|E2|Reported Event|Placebo 8 mg Tablets|Placebo 8 mg tablets
354550|NCT00745030|E1|Reported Event|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
354551|NCT00744978|B3|Baseline|Total|Total of all reporting groups
354552|NCT00744978|B2|Baseline|Placebo Then Varenicline|Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
354553|NCT00744978|B1|Baseline|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
354554|NCT00744978|P2|Participant Flow|Placebo Then Varenicline|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
354555|NCT00744978|P1|Participant Flow|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
354556|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354557|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354558|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354559|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354560|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354561|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354562|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354563|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354564|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354565|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354566|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354567|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354568|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354569|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354570|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354571|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354572|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354573|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354574|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354575|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354576|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354577|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354578|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354579|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354580|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354581|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354582|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354583|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354584|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354585|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354586|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354587|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354588|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354589|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354590|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354591|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354592|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354593|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354594|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354595|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354596|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354597|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354598|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354599|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354600|NCT00744978|E2|Reported Event|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
354601|NCT00744978|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
354602|NCT00744939|B5|Baseline|Total|Total of all reporting groups
354603|NCT00744939|B4|Baseline|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354604|NCT00744939|B3|Baseline|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354605|NCT00744939|B2|Baseline|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
354606|NCT00744939|B1|Baseline|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354607|NCT00744939|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354608|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354609|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354610|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354611|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
354612|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354613|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354614|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354615|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354616|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
354617|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354618|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354619|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354620|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354621|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
354622|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354623|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354624|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
359274|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
354625|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354626|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
354627|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354628|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354629|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354630|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354631|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
354632|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354633|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
354634|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354635|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354636|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
354637|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354638|NCT00744939|E4|Reported Event|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
354639|NCT00744939|E3|Reported Event|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
354640|NCT00744939|E2|Reported Event|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
354641|NCT00744939|E1|Reported Event|Mild Renal Impairment|Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
354642|NCT00744874|B1|Baseline|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354643|NCT00744874|P1|Participant Flow|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354644|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354645|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354646|NCT00744874|O1|Outcome|Cumulative Radio Frequency Time for PV Isolation|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354647|NCT00744874|O3|Outcome|Quality of Life Scores at 6 Months|Quality of life scores at 6 months or 6 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354648|NCT00744874|O2|Outcome|Quality of Life Scores at 3 Months|Quality of life scores at 3 months or 3 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354649|NCT00744874|O1|Outcome|Baseline Quality of Life Scores|Quality of life scores at baseline or before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354650|NCT00744874|O3|Outcome|Ablated Patients Symptom Severity Score at 6 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
354651|NCT00744874|O2|Outcome|Ablated Patients Symptom Severity Score at 3 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.
354652|NCT00744874|O1|Outcome|Ablated Patients Symptom Severity Score at Baseline|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at baseline.
354653|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354654|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354655|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
359275|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
354656|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354657|NCT00744874|E1|Reported Event|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
354658|NCT00744848|B3|Baseline|Total|Total of all reporting groups
354659|NCT00744848|B2|Baseline|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
354660|NCT00744848|B1|Baseline|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
354661|NCT00744848|P2|Participant Flow|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
354662|NCT00744848|P1|Participant Flow|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
354663|NCT00744848|O2|Outcome|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
354664|NCT00744848|O1|Outcome|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
354665|NCT00744848|E2|Reported Event|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
354666|NCT00744848|E1|Reported Event|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
354667|NCT00744757|B1|Baseline|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354668|NCT00744757|P1|Participant Flow|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354669|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354670|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354671|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354672|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354673|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354674|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354675|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354676|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354677|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354678|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354679|NCT00744757|E1|Reported Event|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
354680|NCT00744692|B1|Baseline|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354681|NCT00744692|P1|Participant Flow|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354682|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354683|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354684|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354685|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354686|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354687|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354688|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354689|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354690|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354691|NCT00744692|E1|Reported Event|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
354692|NCT00744653|B1|Baseline|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
354693|NCT00744653|P1|Participant Flow|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
354694|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
354695|NCT00744653|O1|Outcome|Electrochemotherapy|All patients treated with electrochemotherapy
354696|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
354697|NCT00744653|E1|Reported Event|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
354698|NCT00744627|B3|Baseline|Total|Total of all reporting groups
354699|NCT00744627|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354700|NCT00744627|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354701|NCT00744627|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354702|NCT00744627|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354703|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354704|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354705|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354706|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354707|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354708|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354709|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354710|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354711|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354712|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354713|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354714|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354715|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354716|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354717|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354718|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354719|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354720|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359276|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
354721|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354722|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354723|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354724|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354725|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354726|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354727|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354728|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354729|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354730|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354731|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354732|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354733|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354734|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354735|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354736|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354737|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354738|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354739|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354740|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354741|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354742|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354743|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354744|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354745|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354746|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354747|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354748|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354749|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354750|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354751|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354752|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354753|NCT00744627|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
354754|NCT00744627|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
354755|NCT00744523|B3|Baseline|Total|Total of all reporting groups
354756|NCT00744523|B2|Baseline|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354757|NCT00744523|B1|Baseline|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354758|NCT00744523|P2|Participant Flow|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354759|NCT00744523|P1|Participant Flow|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354760|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354761|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354762|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354763|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354792|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354764|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354765|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354766|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354767|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354768|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354769|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354770|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354771|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354772|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
354773|NCT00744523|O1|Outcome|MO.MA Training Cases (Roll-In)|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354774|NCT00744523|E2|Reported Event|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354775|NCT00744523|E1|Reported Event|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
354776|NCT00744497|B3|Baseline|Total|Total of all reporting groups
354777|NCT00744497|B2|Baseline|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354778|NCT00744497|B1|Baseline|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354779|NCT00744497|P2|Participant Flow|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354780|NCT00744497|P1|Participant Flow|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354781|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354782|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354783|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354784|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354785|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354786|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354787|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354788|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354789|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354790|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354791|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354966|NCT00743444|P1|Participant Flow|AZD3355 First, Then Placebo|65 mg drug or placebo capsules, oral, 3 single doses
354793|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354794|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354795|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354796|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354797|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354798|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354799|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354800|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354801|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354802|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354803|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354804|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354805|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354806|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354807|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354808|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354809|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354810|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354811|NCT00744497|E2|Reported Event|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354812|NCT00744497|E1|Reported Event|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
354813|NCT00744055|B3|Baseline|Total|Total of all reporting groups
354814|NCT00744055|B2|Baseline|Placebo|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
354815|NCT00744055|B1|Baseline|Prazosin|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
354816|NCT00744055|P2|Participant Flow|Placebo|"Placebo in identical looking capsule blister packs~Placebo: Placebo"
354817|NCT00744055|P1|Participant Flow|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
354818|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
354819|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
354820|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
354821|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
354822|NCT00744055|E2|Reported Event|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
354823|NCT00744055|E1|Reported Event|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
354824|NCT00744042|B1|Baseline|Asfotase Alfa|All enrolled patients receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients begin thrice weekly SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for the remaining 23 weeks of the study.
354825|NCT00744042|P1|Participant Flow|Asfotase Alfa|All patients received an initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa for the first week followed by regular administration of subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times/week (total 3 mg/kg/week).
354826|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
354967|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
354968|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
354827|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
354828|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2mg/mg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
354829|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
354830|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
354831|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
354832|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
354833|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
354834|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
354835|NCT00744042|O1|Outcome|Asfotase Alfa|All HPP affected infants will receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients will then begin every other day SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for 23 weeks. End of Study will be at 24 weeks.
354836|NCT00744042|E1|Reported Event|Asfotase Alfa|All patients who received any asfotase alfa treatment, regardless of whether they were lost to follow-up or dropped out of the trial.
354837|NCT00743730|B4|Baseline|Total|Total of all reporting groups
354838|NCT00743730|B3|Baseline|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
354839|NCT00743730|B2|Baseline|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354840|NCT00743730|B1|Baseline|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354841|NCT00743730|P3|Participant Flow|Medication as Needed|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
354842|NCT00743730|P2|Participant Flow|PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354843|NCT00743730|P1|Participant Flow|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354844|NCT00743730|O3|Outcome|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
354845|NCT00743730|O2|Outcome|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354870|NCT00743652|P3|Participant Flow|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354846|NCT00743730|O1|Outcome|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354847|NCT00743730|O3|Outcome|Intermittent Opioid on as Needed Basis|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
354848|NCT00743730|O2|Outcome|PNCA Without Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354849|NCT00743730|O1|Outcome|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354850|NCT00743730|E3|Reported Event|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
354851|NCT00743730|E2|Reported Event|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354852|NCT00743730|E1|Reported Event|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
354853|NCT00743717|B3|Baseline|Total|Total of all reporting groups
354854|NCT00743717|B2|Baseline|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
354855|NCT00743717|B1|Baseline|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
354856|NCT00743717|P2|Participant Flow|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
354857|NCT00743717|P1|Participant Flow|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
354858|NCT00743717|O2|Outcome|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
354859|NCT00743717|O1|Outcome|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
354860|NCT00743717|E2|Reported Event|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
354861|NCT00743717|E1|Reported Event|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
354862|NCT00743652|B6|Baseline|Total|Total of all reporting groups
354863|NCT00743652|B5|Baseline|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354864|NCT00743652|B4|Baseline|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354865|NCT00743652|B3|Baseline|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354866|NCT00743652|B2|Baseline|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354867|NCT00743652|B1|Baseline|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354868|NCT00743652|P5|Participant Flow|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354869|NCT00743652|P4|Participant Flow|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354969|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
354871|NCT00743652|P2|Participant Flow|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354872|NCT00743652|P1|Participant Flow|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354873|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354874|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354875|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354876|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354877|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354878|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354879|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354880|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354881|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354882|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354883|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354884|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354885|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354886|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354887|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354888|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354889|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354890|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354891|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354892|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354916|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354970|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
354893|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354894|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354895|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354896|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354897|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354898|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354899|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354900|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354901|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354902|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354903|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354904|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354905|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354906|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354907|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354908|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354909|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354910|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354911|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354912|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354913|NCT00743652|O1|Outcome|13vPnC (All Participants)|All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose.
354914|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354915|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354917|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354918|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354919|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354920|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354921|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354922|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354923|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354924|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354925|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354926|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354927|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354928|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354929|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354930|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354931|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354932|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354933|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354934|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354935|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354936|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
354937|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
354938|NCT00743652|E8|Reported Event|Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
354939|NCT00743652|E7|Reported Event|Group 4 (2 Catch-Up Doses)|Participants ≥12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
354940|NCT00743652|E6|Reported Event|Group 3 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
354941|NCT00743652|E5|Reported Event|Group 2 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
354942|NCT00743652|E4|Reported Event|Group 1 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
354943|NCT00743652|E3|Reported Event|Group 3 (Infant Series)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
359277|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
354944|NCT00743652|E2|Reported Event|Group 2 (Infant Series)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
354945|NCT00743652|E1|Reported Event|Group 1 (Infant Series)|Participants 6 weeks to <10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
354946|NCT00743574|B1|Baseline|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354947|NCT00743574|P1|Participant Flow|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354948|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354949|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354950|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354951|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354952|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354953|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354954|NCT00743574|E1|Reported Event|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
354955|NCT00743509|B1|Baseline|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
354956|NCT00743509|P1|Participant Flow|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
354957|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
354958|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
354959|NCT00743509|E1|Reported Event|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
354960|NCT00743483|B1|Baseline|BSSL|Bucelipase alfa (INN): oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
354961|NCT00743483|P1|Participant Flow|rhBSSL|Oral suspension, 170 mg rhBSSL, 3 times daily for 5-6 days
354962|NCT00743483|O1|Outcome|rhBSSL|oral suspension, 170 mg, 3 times daily for 5-6 days
354963|NCT00743483|E1|Reported Event|BSSL|Oral suspension, 170 mg, 3 times daily for 5-6 days
354964|NCT00743444|B1|Baseline|Entire Study Population|Includes groups randomized to received Drug first and Placebo first.
354965|NCT00743444|P2|Participant Flow|Placebo First, Then AZD3355|65 mg drug or placebo capsules, oral, 3 single doses
354971|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
354972|NCT00743444|E2|Reported Event|Placebo|placebo capsules, oral, 3 single doses
354973|NCT00743444|E1|Reported Event|AZD3355|65 mg drug capsules, oral, 3 single doses
354974|NCT00743431|B1|Baseline|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
354975|NCT00743431|P1|Participant Flow|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
354976|NCT00743431|O1|Outcome|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
354977|NCT00743431|E1|Reported Event|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
354978|NCT00743288|B1|Baseline|Melphalan and Panobinostat (LBH589)|"Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
354979|NCT00743288|P7|Participant Flow|Melphalan and Panobinostat Schedule D3|20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
354980|NCT00743288|P6|Participant Flow|Melphalan and Panobinostat Schedule D2|15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
354981|NCT00743288|P5|Participant Flow|Melphalan and Panobinostat Schedule D1|15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
354982|NCT00743288|P4|Participant Flow|Melphalan and Panobinostat Schedule C|20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
354983|NCT00743288|P3|Participant Flow|Melphalan and Panobinostat Schedule B2|20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
354984|NCT00743288|P2|Participant Flow|Melphalan and Panobinostat Schedule B1|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
354985|NCT00743288|P1|Participant Flow|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
354986|NCT00743288|O5|Outcome|Melphalan and Panobinostat All Patients|Data for all patients irrespective of dosage
354987|NCT00743288|O4|Outcome|Melphalan and Panobinostat Schedule D|"Schedules D1, D2 and D3~D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1"
354988|NCT00743288|O3|Outcome|Melphalan and Panobinostat Schedule C|0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
354989|NCT00743288|O2|Outcome|Melphalan and Panobinostat Schedule B|"Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.~B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1"
354990|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
354991|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
354992|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
354993|NCT00743288|O1|Outcome|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
354994|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule B|"B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.~B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1."
354995|NCT00743288|E1|Reported Event|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
354996|NCT00743275|B3|Baseline|Total|Total of all reporting groups
354997|NCT00743275|B2|Baseline|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
354998|NCT00743275|B1|Baseline|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
354999|NCT00743275|P2|Participant Flow|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355000|NCT00743275|P1|Participant Flow|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355001|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355002|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355003|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355004|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355005|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355006|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355007|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355008|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355009|NCT00743275|E2|Reported Event|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
355010|NCT00743275|E1|Reported Event|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
355011|NCT00743262|B1|Baseline|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355012|NCT00743262|P1|Participant Flow|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355013|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355014|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355015|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355016|NCT00743262|E1|Reported Event|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
355017|NCT00743249|B3|Baseline|Total|Total of all reporting groups
355018|NCT00743249|B2|Baseline|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355019|NCT00743249|B1|Baseline|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355020|NCT00743249|P2|Participant Flow|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355021|NCT00743249|P1|Participant Flow|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355022|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355023|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355024|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355025|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355026|NCT00743249|E2|Reported Event|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355027|NCT00743249|E1|Reported Event|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
355028|NCT00743197|B3|Baseline|Total|Total of all reporting groups
355029|NCT00743197|B2|Baseline|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
355030|NCT00743197|B1|Baseline|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
355031|NCT00743197|P2|Participant Flow|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
355032|NCT00743197|P1|Participant Flow|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
355033|NCT00743197|O2|Outcome|Medical Treatment Group|
355034|NCT00743197|O1|Outcome|Usual Care Group|
355035|NCT00743197|E2|Reported Event|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
355036|NCT00743197|E1|Reported Event|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
355037|NCT00742183|B3|Baseline|Total|Total of all reporting groups
355038|NCT00742183|B2|Baseline|Silvadene|
355039|NCT00742183|B1|Baseline|Mepilex Ag|
355040|NCT00742183|P2|Participant Flow|Silvadene|Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
355041|NCT00742183|P1|Participant Flow|Mepilex Ag|"Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.~Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn"
355042|NCT00742183|O2|Outcome|Silvadene|
355043|NCT00742183|O1|Outcome|Mepilex Ag|
355044|NCT00742183|E2|Reported Event|Silvadene|
355045|NCT00742183|E1|Reported Event|Mepilex Ag|
355046|NCT00742170|B3|Baseline|Total|Total of all reporting groups
355091|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355497|NCT00741611|B3|Baseline|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355047|NCT00742170|B2|Baseline|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355048|NCT00742170|B1|Baseline|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355049|NCT00742170|P2|Participant Flow|Sham Electroacupuncture Condition|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355050|NCT00742170|P1|Participant Flow|Active Electroacupuncture Condition|"Active electroacupuncture condition~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355051|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355052|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355053|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355054|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355055|NCT00742170|E2|Reported Event|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355092|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355128|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
355056|NCT00742170|E1|Reported Event|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
355057|NCT00742079|B3|Baseline|Total|Total of all reporting groups
355058|NCT00742079|B2|Baseline|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
355059|NCT00742079|B1|Baseline|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
355060|NCT00742079|P2|Participant Flow|2 Placebo First, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
355061|NCT00742079|P1|Participant Flow|1 D-cycloserine First, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
355062|NCT00742079|O2|Outcome|Placebo, D-cycloserine|Participants will receive 50 mg of placebo 1 hour before a CBT session on Week 1, and they will receive 50 mg of D-cycloserine 1 hour before a CBT session on Week 2.
355063|NCT00742079|O1|Outcome|D-cycloserine, Placebo|Participants will receive 50 mg of D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive 50 mg of placebo 1 hour before a CBT session on Week 2.
355064|NCT00742079|E2|Reported Event|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
355065|NCT00742079|E1|Reported Event|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
355066|NCT00742053|B1|Baseline|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
355067|NCT00742053|P1|Participant Flow|PICC Insertion|All patients, aged 18 to 80 years, who required Peripherally inserted central catheter (PICC) insertion for their standard care will be studied.
355068|NCT00742053|O1|Outcome|PICC Placement|Patients who require PICC placement
355069|NCT00742053|E1|Reported Event|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
355070|NCT00741988|B3|Baseline|Total|Total of all reporting groups
355071|NCT00741988|B2|Baseline|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355072|NCT00741988|B1|Baseline|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355073|NCT00741988|P2|Participant Flow|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355074|NCT00741988|P1|Participant Flow|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355075|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355076|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355077|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355078|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355079|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355080|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355081|NCT00741988|E2|Reported Event|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
355082|NCT00741988|E1|Reported Event|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
355083|NCT00741936|B3|Baseline|Total|Total of all reporting groups
355084|NCT00741936|B2|Baseline|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355085|NCT00741936|B1|Baseline|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355086|NCT00741936|P2|Participant Flow|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355087|NCT00741936|P1|Participant Flow|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355088|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355089|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355090|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355093|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355094|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355095|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355096|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355097|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355098|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355099|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355100|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355101|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355102|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355103|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355104|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355105|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355106|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355107|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355108|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355109|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355110|NCT00741936|E2|Reported Event|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355111|NCT00741936|E1|Reported Event|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
355112|NCT00743106|B3|Baseline|Total|Total of all reporting groups
355113|NCT00743106|B2|Baseline|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
355114|NCT00743106|B1|Baseline|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
355115|NCT00743106|P2|Participant Flow|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
355116|NCT00743106|P1|Participant Flow|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
355117|NCT00743106|O2|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
355118|NCT00743106|O1|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
355119|NCT00743106|E2|Reported Event|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
355120|NCT00743106|E1|Reported Event|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
355121|NCT00743093|B3|Baseline|Total|Total of all reporting groups
355122|NCT00743093|B2|Baseline|Placebo Arm|placebo
355123|NCT00743093|B1|Baseline|Acetaminophen Arm|acetaminophen 500 mg
355124|NCT00743093|P2|Participant Flow|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
355125|NCT00743093|P1|Participant Flow|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
355126|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
355127|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
355129|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
355130|NCT00743093|E2|Reported Event|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
355131|NCT00743093|E1|Reported Event|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
355132|NCT00742924|B5|Baseline|Total|Total of all reporting groups
355133|NCT00742924|B4|Baseline|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355134|NCT00742924|B3|Baseline|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355135|NCT00742924|B2|Baseline|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355136|NCT00742924|B1|Baseline|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355137|NCT00742924|P4|Participant Flow|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355138|NCT00742924|P3|Participant Flow|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355165|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355166|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355311|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355139|NCT00742924|P2|Participant Flow|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355140|NCT00742924|P1|Participant Flow|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355141|NCT00742924|O4|Outcome|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355142|NCT00742924|O3|Outcome|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355143|NCT00742924|O2|Outcome|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355144|NCT00742924|O1|Outcome|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355145|NCT00742924|E4|Reported Event|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355167|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355495|NCT00741819|E1|Reported Event|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
355146|NCT00742924|E3|Reported Event|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355147|NCT00742924|E2|Reported Event|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355148|NCT00742924|E1|Reported Event|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
355149|NCT00742885|B3|Baseline|Total|Total of all reporting groups
355150|NCT00742885|B2|Baseline|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355151|NCT00742885|B1|Baseline|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355152|NCT00742885|P2|Participant Flow|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355153|NCT00742885|P1|Participant Flow|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355154|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355155|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355156|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355157|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355158|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
355159|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355160|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355161|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355162|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355163|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355164|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355168|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group.|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355169|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group.|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355170|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355171|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355172|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355173|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355174|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355175|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355176|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355177|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355178|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355179|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355180|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355181|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355182|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355183|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355184|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355185|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355186|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355187|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355188|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355189|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355190|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355191|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355192|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355293|NCT00742417|P2|Participant Flow|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355193|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355194|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355195|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355196|NCT00742885|E2|Reported Event|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355197|NCT00742885|E1|Reported Event|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
355198|NCT00742872|B3|Baseline|Total|Total of all reporting groups
355199|NCT00742872|B2|Baseline|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
355200|NCT00742872|B1|Baseline|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
355201|NCT00742872|P2|Participant Flow|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
355202|NCT00742872|P1|Participant Flow|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
355203|NCT00742872|O2|Outcome|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
355204|NCT00742872|O1|Outcome|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
355205|NCT00742872|E2|Reported Event|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
355206|NCT00742872|E1|Reported Event|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
355207|NCT00742781|B1|Baseline|Vitamin D Supplementation|
355208|NCT00742781|P1|Participant Flow|Vitamin D Supplementation|
355209|NCT00742781|O2|Outcome|Vitamin D Supplemented|
355210|NCT00742781|O1|Outcome|Baseline|
355211|NCT00742781|O2|Outcome|Vitamin D Supplemented|
355212|NCT00742781|O1|Outcome|Baseline|
355213|NCT00742781|O2|Outcome|Vitamin D Supplemented|
355214|NCT00742781|O1|Outcome|Baseline|
355215|NCT00742781|E1|Reported Event|Vitamin D Supplemented|
355216|NCT00742625|B1|Baseline|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
355217|NCT00742625|P1|Participant Flow|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
355218|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
355219|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
355220|NCT00742625|O3|Outcome|Bortezomib (1.3 mg/m^2) + Int-DAC|Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
355221|NCT00742625|O2|Outcome|Bortezomib (1.0 mg/m^2) + Int-DAC|Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
355222|NCT00742625|O1|Outcome|Bortezomib (0.7 mg/m^2) + Int-DAC|Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
355223|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
355224|NCT00742625|E1|Reported Event|Bortezomib + Daunorubicin + Cytarabine|Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
355225|NCT00742508|B3|Baseline|Total|Total of all reporting groups
355294|NCT00742417|P1|Participant Flow|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355295|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355310|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355226|NCT00742508|B2|Baseline|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355227|NCT00742508|B1|Baseline|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355228|NCT00742508|P2|Participant Flow|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355229|NCT00742508|P1|Participant Flow|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355230|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355231|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355232|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355233|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355296|NCT00742417|O1|Outcome|Albutein 5%|"Patients allocated to this arm will undergo plasma exchange with Albutein 5%.~Albutein 5%: 18 Plasma Exchanges using~Albutein 5% or~Sham Procedure~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355297|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355234|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355235|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355236|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355237|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355238|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355239|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355240|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355241|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355298|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355299|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355496|NCT00741611|B4|Baseline|Total|Total of all reporting groups
355242|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355243|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355244|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355245|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355246|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355247|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355248|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355249|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355300|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355301|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355498|NCT00741611|B2|Baseline|Drug|Treatment with anti-arrhythmic drugs
355250|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355251|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355252|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355253|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355254|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355255|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355256|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355257|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355302|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355303|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355499|NCT00741611|B1|Baseline|Mesh|Ablation with HD Mesh Ablation System
355258|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355259|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355260|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355261|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355262|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355263|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355264|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355265|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355304|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355305|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355833|NCT00740792|B3|Baseline|Fluticasone Propionate|active comparator of fluticasone propionate
355266|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355267|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355268|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355269|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355270|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355271|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355272|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355273|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355306|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355307|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355834|NCT00740792|B2|Baseline|Azelastine HCL|active comparator of azelastine HCl
355274|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355275|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355276|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355277|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355278|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355279|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355280|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355281|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355308|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355309|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
359278|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
355282|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355283|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355284|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355285|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355286|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355287|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355288|NCT00742508|E2|Reported Event|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
355289|NCT00742508|E1|Reported Event|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
355290|NCT00742417|B3|Baseline|Total|Total of all reporting groups
355291|NCT00742417|B2|Baseline|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355292|NCT00742417|B1|Baseline|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355312|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355313|NCT00742417|E2|Reported Event|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
355314|NCT00742417|E1|Reported Event|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
355315|NCT00742391|B3|Baseline|Total|Total of all reporting groups
355316|NCT00742391|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
355317|NCT00742391|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
355318|NCT00742391|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
355319|NCT00742391|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
355320|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
355321|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
355322|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
355323|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
355324|NCT00742391|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
355325|NCT00742391|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
355326|NCT00742326|B3|Baseline|Total|Total of all reporting groups
355327|NCT00742326|B2|Baseline|Placebo|Placebo once daily for 48 weeks
355328|NCT00742326|B1|Baseline|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
355329|NCT00742326|P2|Participant Flow|Placebo|Placebo once daily for 48 weeks
355330|NCT00742326|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
355331|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
355332|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
355333|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
355334|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
355335|NCT00742326|E2|Reported Event|Placebo|Placebo once daily for 48 weeks
355336|NCT00742326|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
355337|NCT00742313|B3|Baseline|Total|Total of all reporting groups
355338|NCT00742313|B2|Baseline|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
355339|NCT00742313|B1|Baseline|FloSeal|Arm A has FloSeal Matrix applied to EVH wound bed.
355340|NCT00742313|P2|Participant Flow|Non-FloSeal Matrix|FloSeal Matrix was not added to the wound bed
355341|NCT00742313|P1|Participant Flow|FloSeal Matrix|FloSeal Matrix applied to EVH wound bed.
355342|NCT00742313|O2|Outcome|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
355343|NCT00742313|O1|Outcome|FloSeal Matrix|Arm A has FloSeal Matrix applied to EVH wound bed.
355344|NCT00742313|E2|Reported Event|Arm B|Arm B does not have FloSeal Matrix applied to EVH wound bed.
355345|NCT00742313|E1|Reported Event|Arm A|Arm A has FloSeal Matrix applied to EVH wound bed.
355346|NCT00742274|B3|Baseline|Total|Total of all reporting groups
355347|NCT00742274|B2|Baseline|BEST MEDICAL THERAPY (BMT) Alone|
355348|NCT00742274|B1|Baseline|TAG Device + Best Medical Therapy (BMT)|
355349|NCT00742274|P2|Participant Flow|Best Medical Therapy (BMT) Alone|BMT alone
355350|NCT00742274|P1|Participant Flow|TAG Device + Best Medical Therapy (BMT)|TAG+BMT
355351|NCT00742274|O2|Outcome|BEST MEDICAL THERAPY (BMT) Alone|
355352|NCT00742274|O1|Outcome|TAG Device + Best Medical Therapy (BMT)|
355353|NCT00742274|E2|Reported Event|BEST MEDICAL THERAPY (BMT) Alone|
355354|NCT00742274|E1|Reported Event|TAG Device + Best Medical Therapy (BMT)|
355355|NCT00742235|B3|Baseline|Total|Total of all reporting groups
355356|NCT00742235|B2|Baseline|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
355357|NCT00742235|B1|Baseline|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
355358|NCT00742235|P2|Participant Flow|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)
355359|NCT00742235|P1|Participant Flow|Vitamin D Sufficient|Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
355360|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
355361|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
355362|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
355363|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
355364|NCT00742235|E2|Reported Event|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
355365|NCT00742235|E1|Reported Event|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
355366|NCT00742209|B6|Baseline|Total|Total of all reporting groups
355367|NCT00742209|B5|Baseline|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
355368|NCT00742209|B4|Baseline|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
355369|NCT00742209|B3|Baseline|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
355370|NCT00742209|B2|Baseline|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
355371|NCT00742209|B1|Baseline|Placebo|Oral GEn (XP13512) placebo on Weeks 1-17
355372|NCT00742209|P5|Participant Flow|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
355373|NCT00742209|P4|Participant Flow|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355374|NCT00742209|P3|Participant Flow|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355375|NCT00742209|P2|Participant Flow|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
355376|NCT00742209|P1|Participant Flow|Placebo|Oral GEn (XP13512) placebo
355377|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355378|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355379|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355380|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355381|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355382|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355383|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355384|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355385|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355386|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355387|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355388|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355389|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355390|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355391|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355392|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355393|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355394|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355395|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355396|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355397|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355398|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355399|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355400|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355401|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355402|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355403|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355404|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355405|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355406|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355407|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355408|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355409|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355410|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355411|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355412|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355413|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355414|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355415|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355416|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355417|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355418|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355419|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355420|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355421|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355422|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355423|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355424|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355425|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355426|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355427|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355428|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355429|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355430|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355431|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355432|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355433|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355434|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355435|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355436|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355437|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355438|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355439|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355440|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355441|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355442|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355443|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355444|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355445|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355446|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355447|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355448|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355449|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355450|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355451|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355452|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355453|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355454|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355455|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355456|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355835|NCT00740792|B1|Baseline|MP29-02|azelastine HCl/fluticasone propionate
355457|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355458|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355459|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355460|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355461|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355462|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355463|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355464|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355465|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355466|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355467|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355468|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355469|NCT00742209|O2|Outcome|Average of GEn 1800/2400 mg|Average of GEn 1800 mg group and GEn 2400 mg group
355470|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
355471|NCT00742209|E5|Reported Event|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
355472|NCT00742209|E4|Reported Event|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
355473|NCT00742209|E3|Reported Event|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
355474|NCT00742209|E2|Reported Event|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
355475|NCT00742209|E1|Reported Event|Placebo|Oral GEn (XP13512) placebo
355476|NCT00741858|B3|Baseline|Total|Total of all reporting groups
355477|NCT00741858|B2|Baseline|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
355478|NCT00741858|B1|Baseline|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
355479|NCT00741858|P2|Participant Flow|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
355480|NCT00741858|P1|Participant Flow|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
355481|NCT00741858|O2|Outcome|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
355482|NCT00741858|O1|Outcome|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
355483|NCT00741858|E2|Reported Event|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
355484|NCT00741858|E1|Reported Event|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
355485|NCT00741819|B1|Baseline|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
355486|NCT00741819|P1|Participant Flow|Inhaled Treprostinil|Inhaled treprostinil was given four times daily at doses titrated up to 12 breaths.
355487|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355488|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355489|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355490|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355491|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355492|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
355493|NCT00741819|O1|Outcome|Inhaled Treprostinil|Up to 12 breaths four times daily.
355494|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily
355500|NCT00741611|P3|Participant Flow|Roll-ins|Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
355501|NCT00741611|P2|Participant Flow|Drug|Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
355502|NCT00741611|P1|Participant Flow|Mesh|Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
355503|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355504|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
355505|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355506|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
355507|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355508|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
355509|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
355510|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355511|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
355512|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
355513|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355514|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
355515|NCT00741611|E3|Reported Event|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
355516|NCT00741611|E2|Reported Event|Drug|Treatment with anti-arrhythmic drugs
355517|NCT00741611|E1|Reported Event|Mesh|Ablation with HD Mesh Ablation System
355518|NCT00741468|B1|Baseline|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
355519|NCT00741468|P1|Participant Flow|All Participants|CYP1A2, Day 8 relative to Day 1 AUC (caffeine probe) CYP2C19, Day 8 relative to Day 1 AUC (omeprazole probe) CYP 2C9, Day 8 relative to Day 1 AUC (tolbutamide probe) CYP2D6, Day 8 relative to Day 1 AUC (dextromethorphan probe) CYP3A4, Day 8 relative to Day 1 AUC (midazolam probe)
355520|NCT00741468|O5|Outcome|CYP3A4|Day 8 relative to Day 1 AUC (midazolam probe)
355521|NCT00741468|O4|Outcome|CYP2D6|Day 8 relative to Day 1 AUC (dextromethorphan probe)
355522|NCT00741468|O3|Outcome|CYP2C19|Day 8 relative to Day 1 AUC (omeprazole probe)
355523|NCT00741468|O2|Outcome|CYP2C9|Day 8 relative to Day 1 AUC (tolbutamide probe)
355524|NCT00741468|O1|Outcome|CYP1A2|Day 8 relative to Day 1 AUC (caffeine probe)
355525|NCT00741468|E1|Reported Event|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
355526|NCT00741390|B1|Baseline|Entire Study Population|
355527|NCT00741390|P4|Participant Flow|Arm D|Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used.
355528|NCT00741390|P3|Participant Flow|Arm C|Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used.
355529|NCT00741390|P2|Participant Flow|Arm B|Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used.
355530|NCT00741390|P1|Participant Flow|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used.
355531|NCT00741390|O4|Outcome|OTM/28G - OTM/33G|OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet
355532|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
355533|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
355534|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
355535|NCT00741390|O1|Outcome|OTM/28G - OTM/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet
355536|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
355537|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
355538|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
355539|NCT00741390|O5|Outcome|ACC/28G|"Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet~See description for BD/33G."
355540|NCT00741390|O4|Outcome|OTU/28G|"OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
355541|NCT00741390|O3|Outcome|OTM/28G|"OneTouch Mini Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
355542|NCT00741390|O2|Outcome|OTM/33G|"OneTouch Mini Device / BD 33 Gauge Lancet~See description for BD/33G."
355543|NCT00741390|O1|Outcome|BD/33G|"BD Lancet Device / BD 33 Gauge Lancet.~In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2."
355544|NCT00741390|E4|Reported Event|Arm D|Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
355545|NCT00741390|E3|Reported Event|Arm C|Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
355546|NCT00741390|E2|Reported Event|Arm B|Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
355547|NCT00741390|E1|Reported Event|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
355548|NCT00741338|B3|Baseline|Total|Total of all reporting groups
355549|NCT00741338|B2|Baseline|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
355550|NCT00741338|B1|Baseline|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
355551|NCT00741338|P2|Participant Flow|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
355552|NCT00741338|P1|Participant Flow|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
355553|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
355554|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
355592|NCT00741156|O5|Outcome|Cerebral Resistance at Baseline|cerebral resistance is measured in baseline condition
355555|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
355556|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
355557|NCT00741338|E2|Reported Event|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low- dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
355558|NCT00741338|E1|Reported Event|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
355559|NCT00741286|B3|Baseline|Total|Total of all reporting groups
355560|NCT00741286|B2|Baseline|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
355561|NCT00741286|B1|Baseline|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
355562|NCT00741286|P2|Participant Flow|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
355563|NCT00741286|P1|Participant Flow|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
355564|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
355565|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
355566|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
355567|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
355568|NCT00741286|E2|Reported Event|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
355569|NCT00741286|E1|Reported Event|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
355570|NCT00741273|B3|Baseline|Total|Total of all reporting groups
355571|NCT00741273|B2|Baseline|Mpaired|Hepatically impaired females
355572|NCT00741273|B1|Baseline|Healthy|Healthy females
355573|NCT00741273|P2|Participant Flow|Impaired|Proellex single dose each of 25 mg and 50 mg in hepatically impaired females
355574|NCT00741273|P1|Participant Flow|Healthy|Proellex single dose each of 25 mg and 50 mg in healthy females
355575|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
355576|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
355577|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
355578|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
355579|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
355580|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
355581|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
355582|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
355583|NCT00741273|O4|Outcome|Proellex 50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
355584|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
355585|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 50 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
355586|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
355587|NCT00741273|E2|Reported Event|Proellex Impaired|"Proellex 25 mg and 50 mg in hepatically impaired females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
355588|NCT00741273|E1|Reported Event|Proellex Healthy|"Proellex 25 mg and 50 mg in healthy females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
355589|NCT00741156|B1|Baseline|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
355590|NCT00741156|P1|Participant Flow|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
355591|NCT00741156|O6|Outcome|Cerebral Resistance After Enalaprilat|cerebral resistance is measured after enalaprilat
355635|NCT00741026|O1|Outcome|Placebo|
355593|NCT00741156|O4|Outcome|Pulmonary Resistance After Enalaprilat|pulmonary resistance is measured after enalaprilat
355594|NCT00741156|O3|Outcome|Pulmonary Resistance at Baseline|pulmonary resistance at baseline is measured
355595|NCT00741156|O2|Outcome|Systemic Resistance After Enalaprilat|systemic resistance is measured after enalaprilat
355596|NCT00741156|O1|Outcome|Systemic Resistance at Baseline|systemic resistance in baseline condition
355597|NCT00741156|O6|Outcome|Cerebral Blood Flow After Enalaprilat|Cerebral blood flow 20 minutes after enalaprilat
355598|NCT00741156|O5|Outcome|Cerebral Blood Flow Baseline|Cerebral blood flow at baseline
355599|NCT00741156|O4|Outcome|Pulmonary Blood Flow After Enaliprilat|Pulmonary blood flow 20 minutes after enalaprilat
355600|NCT00741156|O3|Outcome|Pulmonary Blood Flow Baseline|Pulmonary blood flow baseline condition
355601|NCT00741156|O2|Outcome|Systemic Blood Flow After Enalaprilat|Systemic blood flow 20 minutes after enalaprilat
355602|NCT00741156|O1|Outcome|Systemic Blood Flow Baseline|Systemic blood flow in baseline condition
355603|NCT00741156|E1|Reported Event|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
355604|NCT00741104|B1|Baseline|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355605|NCT00741104|P1|Participant Flow|RA Patients|Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.
355606|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355607|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355608|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355609|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355610|NCT00741104|E1|Reported Event|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
355611|NCT00741091|B1|Baseline|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355612|NCT00741091|P1|Participant Flow|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355613|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355614|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355615|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355616|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355617|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355618|NCT00741091|E1|Reported Event|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
355619|NCT00741039|B3|Baseline|Total|Total of all reporting groups
355620|NCT00741039|B2|Baseline|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
355621|NCT00741039|B1|Baseline|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
355622|NCT00741039|P2|Participant Flow|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
355623|NCT00741039|P1|Participant Flow|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
355624|NCT00741039|O2|Outcome|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
355625|NCT00741039|O1|Outcome|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
355626|NCT00741039|E2|Reported Event|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
355627|NCT00741039|E1|Reported Event|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
355628|NCT00741026|B1|Baseline|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days."
355629|NCT00741026|P1|Participant Flow|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.~Randomization information not available."
355630|NCT00741026|O2|Outcome|Olanzapine|
355631|NCT00741026|O1|Outcome|Placebo|
355632|NCT00741026|O2|Outcome|Olanzapine|
355633|NCT00741026|O1|Outcome|Placebo|
355634|NCT00741026|O2|Outcome|Olanzapine|
355655|NCT00741026|E1|Reported Event|Placebo|Placebo : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
355656|NCT00741013|B4|Baseline|Total|Total of all reporting groups
355657|NCT00741013|B3|Baseline|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
355658|NCT00741013|B2|Baseline|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
355659|NCT00741013|B1|Baseline|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
355660|NCT00741013|P3|Participant Flow|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
355661|NCT00741013|P2|Participant Flow|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
355662|NCT00741013|P1|Participant Flow|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
355663|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
355664|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
355665|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
355666|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
355667|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
355668|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
355669|NCT00741013|E3|Reported Event|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
355670|NCT00741013|E2|Reported Event|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
355671|NCT00741013|E1|Reported Event|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
355672|NCT00739973|B10|Baseline|Total|Total of all reporting groups
355673|NCT00739973|B9|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355674|NCT00739973|B8|Baseline|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355675|NCT00739973|B7|Baseline|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355676|NCT00739973|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355677|NCT00739973|B5|Baseline|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355678|NCT00739973|B4|Baseline|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355679|NCT00739973|B3|Baseline|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355680|NCT00739973|B2|Baseline|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355681|NCT00739973|B1|Baseline|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355819|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355820|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355821|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355682|NCT00739973|P9|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355683|NCT00739973|P8|Participant Flow|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355684|NCT00739973|P7|Participant Flow|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355685|NCT00739973|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355686|NCT00739973|P5|Participant Flow|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355687|NCT00739973|P4|Participant Flow|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355688|NCT00739973|P3|Participant Flow|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355689|NCT00739973|P2|Participant Flow|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355690|NCT00739973|P1|Participant Flow|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355691|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355692|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355693|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355694|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355695|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355696|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355822|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355697|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355698|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355699|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355700|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355701|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355702|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355703|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355704|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355705|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355706|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355707|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355708|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355709|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355710|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355711|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355823|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355824|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355712|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355713|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355714|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355715|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355716|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355717|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355718|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355719|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355720|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355721|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355722|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355723|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355724|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355725|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355726|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355825|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355826|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355727|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355728|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355729|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355730|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355731|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355732|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355733|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355734|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355735|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355736|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355737|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355738|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355739|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355740|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355741|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355827|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355742|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355743|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355744|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355745|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355746|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355747|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355748|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355749|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355750|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355751|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355752|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355753|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355754|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355755|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355756|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355828|NCT00740831|E3|Reported Event|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355829|NCT00740831|E2|Reported Event|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355757|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355758|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355759|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355760|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355761|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355762|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355763|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355764|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355765|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355766|NCT00739973|E9|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355767|NCT00739973|E8|Reported Event|Aliskiren/Amlodipine 300/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355768|NCT00739973|E7|Reported Event|Aliskiren/Amlodipine 150/10 mg Tablet|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355769|NCT00739973|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355770|NCT00739973|E5|Reported Event|Amlodipine 10 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
355771|NCT00739973|E4|Reported Event|Amlodipine 5 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355830|NCT00740831|E1|Reported Event|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355831|NCT00740792|B5|Baseline|Total|Total of all reporting groups
355832|NCT00740792|B4|Baseline|Placebo|placebo control
355772|NCT00739973|E3|Reported Event|Aliskiren 300 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355773|NCT00739973|E2|Reported Event|Aliskiren 150 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
355774|NCT00739973|E1|Reported Event|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
355775|NCT00740857|B4|Baseline|Total|Total of all reporting groups
355776|NCT00740857|B3|Baseline|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355777|NCT00740857|B2|Baseline|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355778|NCT00740857|B1|Baseline|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355779|NCT00740857|P3|Participant Flow|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355780|NCT00740857|P2|Participant Flow|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355781|NCT00740857|P1|Participant Flow|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355782|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355783|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355784|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355785|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355786|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355787|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355788|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355789|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355790|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355791|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355792|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355793|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355794|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355795|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355796|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355797|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355798|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355799|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355800|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355801|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355802|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355803|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355804|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355805|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355806|NCT00740857|E3|Reported Event|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
355807|NCT00740857|E2|Reported Event|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
355808|NCT00740857|E1|Reported Event|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
355809|NCT00740831|B4|Baseline|Total|Total of all reporting groups
355810|NCT00740831|B3|Baseline|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355811|NCT00740831|B2|Baseline|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355812|NCT00740831|B1|Baseline|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355813|NCT00740831|P3|Participant Flow|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355814|NCT00740831|P2|Participant Flow|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355815|NCT00740831|P1|Participant Flow|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355816|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
355817|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355818|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
355837|NCT00740792|P3|Participant Flow|Fluticasone Propionate|active comparator of fluticasone propionate
355838|NCT00740792|P2|Participant Flow|Azelastine HCL|active comparator of azelastine HCl
355839|NCT00740792|P1|Participant Flow|MP29-02|azelastine HCl/fluticasone propionate
355840|NCT00740792|O4|Outcome|Placebo|placebo control
355841|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
355842|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
355843|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
355844|NCT00740792|O4|Outcome|Placebo|placebo control
355845|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
355846|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
355847|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
355848|NCT00740792|O4|Outcome|Placebo|placebo control
355849|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
355850|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
355851|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
355852|NCT00740792|E4|Reported Event|Placebo|placebo control
355853|NCT00740792|E3|Reported Event|Fluticasone Propionate|active comparator of fluticasone propionate
355854|NCT00740792|E2|Reported Event|Azelastine HCL|active comparator of azelastine HCl
355855|NCT00740792|E1|Reported Event|MP29-02|azelastine HCl/fluticasone propionate
355856|NCT00740779|B4|Baseline|Total|Total of all reporting groups
355857|NCT00740779|B3|Baseline|Placebo|1 placebo capsule daily
355858|NCT00740779|B2|Baseline|Silodosin 8 mg|Silodosin 8 mg daily
355859|NCT00740779|B1|Baseline|Silodosin 4 mg|Silodosin 4 mg daily
355860|NCT00740779|P3|Participant Flow|Placebo|1 placebo capsule daily
355861|NCT00740779|P2|Participant Flow|Silodosin 8 mg|Silodosin 8 mg daily
355862|NCT00740779|P1|Participant Flow|Silodosin 4 mg|Silodosin 4 mg daily
355863|NCT00740779|O3|Outcome|Placebo|1 placebo capsule daily
355864|NCT00740779|O2|Outcome|Silodosin 8 mg|Silodosin 8 mg daily
355865|NCT00740779|O1|Outcome|Silodosin 4 mg|Silodosin 4 mg daily
355866|NCT00740779|E3|Reported Event|Placebo|1 placebo capsule daily
355867|NCT00740779|E2|Reported Event|Silodosin 8 mg|Silodosin 8 mg daily
355868|NCT00740779|E1|Reported Event|Silodosin 4 mg|Silodosin 4 mg daily
355869|NCT00740727|B1|Baseline|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355870|NCT00740727|P1|Participant Flow|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355871|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355872|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355873|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355874|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
355875|NCT00740714|B4|Baseline|Total|Total of all reporting groups
355876|NCT00740714|B3|Baseline|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355877|NCT00740714|B2|Baseline|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355878|NCT00740714|B1|Baseline|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355879|NCT00740714|P3|Participant Flow|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355880|NCT00740714|P2|Participant Flow|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355881|NCT00740714|P1|Participant Flow|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355882|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355883|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355884|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355885|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355886|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355887|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355888|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355889|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355890|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355891|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355892|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355893|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355894|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355895|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355896|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355897|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355898|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355899|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355900|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355901|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355902|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355903|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355904|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355905|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355906|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355907|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355908|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355909|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355910|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355911|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355912|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355913|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355914|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355915|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355916|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355917|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355918|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355919|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355920|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355921|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355922|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355923|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355924|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355925|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355926|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355927|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355928|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355929|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355930|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355931|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355932|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355933|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355934|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355935|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355936|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355937|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355938|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355939|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355940|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355941|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
359279|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
355942|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355943|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355944|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355945|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355946|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355947|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355948|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355949|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355950|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355951|NCT00740714|E3|Reported Event|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
355952|NCT00740714|E2|Reported Event|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
355953|NCT00740714|E1|Reported Event|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
355954|NCT00740636|B3|Baseline|Total|Total of all reporting groups
355955|NCT00740636|B2|Baseline|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
355956|NCT00740636|B1|Baseline|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
355957|NCT00740636|P2|Participant Flow|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
355958|NCT00740636|P1|Participant Flow|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
355959|NCT00740636|O2|Outcome|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
355960|NCT00740636|O1|Outcome|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
355961|NCT00740636|E2|Reported Event|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
355962|NCT00740636|E1|Reported Event|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
355963|NCT00740597|B1|Baseline|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
355964|NCT00740597|P1|Participant Flow|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
355965|NCT00740597|O1|Outcome|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
355966|NCT00740597|E1|Reported Event|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
355967|NCT00740584|B1|Baseline|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
355968|NCT00740584|P1|Participant Flow|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
355969|NCT00740584|O1|Outcome|Open Label Active|
355970|NCT00740584|E1|Reported Event|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
355971|NCT00740480|B1|Baseline|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
355972|NCT00740480|P1|Participant Flow|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
355973|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
355974|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
355975|NCT00740220|B1|Baseline|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
355976|NCT00740220|P1|Participant Flow|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
355977|NCT00740220|O1|Outcome|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
355978|NCT00740220|E1|Reported Event|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
355979|NCT00740207|B3|Baseline|Total|Total of all reporting groups
356004|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356005|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356048|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
355980|NCT00740207|B2|Baseline|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355981|NCT00740207|B1|Baseline|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355982|NCT00740207|P2|Participant Flow|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355983|NCT00740207|P1|Participant Flow|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355984|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355985|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355986|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355987|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355988|NCT00740207|O4|Outcome|VAS Score After Injection of VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355989|NCT00740207|O3|Outcome|VAS Score Prior to Injection of VISIPAQUE 270|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
355990|NCT00740207|O2|Outcome|VAS Score After Injection of ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355991|NCT00740207|O1|Outcome|VAS Score Prior to Injection of ISOVUE 250|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
355992|NCT00740207|E2|Reported Event|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355993|NCT00740207|E1|Reported Event|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
355994|NCT00740181|B1|Baseline|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
355995|NCT00740181|P1|Participant Flow|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
355996|NCT00740181|O1|Outcome|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
355997|NCT00740181|E1|Reported Event|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
355998|NCT00740051|B3|Baseline|Total|Total of all reporting groups
355999|NCT00740051|B2|Baseline|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356000|NCT00740051|B1|Baseline|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356001|NCT00740051|P2|Participant Flow|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356002|NCT00740051|P1|Participant Flow|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356003|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356006|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356007|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356008|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356009|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356010|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356011|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356012|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356013|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356014|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356015|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356016|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356017|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356018|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356019|NCT00740051|E2|Reported Event|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
356020|NCT00740051|E1|Reported Event|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
356021|NCT00739999|B3|Baseline|Total|Total of all reporting groups
356022|NCT00739999|B2|Baseline|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356023|NCT00739999|B1|Baseline|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356024|NCT00739999|P2|Participant Flow|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.
356025|NCT00739999|P1|Participant Flow|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
356026|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg, 20 mg): Tanner Stages 1 and 2+|Tanner Stage 1: Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated; Tanner Stage 2+: Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356027|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356028|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356029|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356030|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356031|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356032|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356033|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356034|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356035|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356036|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356037|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356038|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356039|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356040|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356041|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356042|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356043|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356044|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356045|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356046|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356047|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356049|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356050|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356051|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356052|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356053|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356054|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356055|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356056|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356057|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356058|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356059|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356060|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356061|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356062|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356063|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356064|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356065|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356066|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356067|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356068|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356069|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356070|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356071|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356072|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356073|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356074|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356075|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356076|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356077|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356078|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356079|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356080|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356081|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356082|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356083|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356084|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356085|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356086|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356087|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356088|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
356089|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356090|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
356091|NCT00739999|O2|Outcome|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
356092|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356093|NCT00739999|E2|Reported Event|All Subjects (10 mg, 20 mg): Tanner Stage 2+|Atorvastatin: subjects who stayed at initial dose of 10 mg/day for duration of study and subjects who titrated to 20 mg/day after Week 4 if target LDL-C was not attained and study drug was well tolerated.
356094|NCT00739999|E1|Reported Event|All Subjects (5 mg, 10 mg): Tanner Stage 1|Atorvastatin: subjects who stayed at initial dose of 5 mg/day for duration of study and subjects who titrated after Week 4 to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
356095|NCT00739934|B1|Baseline|All Participants|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
356096|NCT00739934|P1|Participant Flow|All Participants|Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
356097|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356098|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356099|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356100|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
356101|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
356102|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
356103|NCT00739934|O1|Outcome|All Treatments|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
356104|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
356105|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
356106|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
356107|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356108|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356109|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
356110|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
356111|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
356112|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
356113|NCT00739934|E2|Reported Event|Voriconazole Oral|Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
356114|NCT00739934|E1|Reported Event|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
356115|NCT00739908|B3|Baseline|Total|Total of all reporting groups
356116|NCT00739908|B2|Baseline|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356117|NCT00739908|B1|Baseline|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356118|NCT00739908|P2|Participant Flow|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356119|NCT00739908|P1|Participant Flow|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356120|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356121|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356122|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356123|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356124|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356125|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356126|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356127|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356128|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356129|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356130|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356131|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356132|NCT00739908|O2|Outcome|Oral Placebo TID|No active medication, the same as a Sugar Pill
356133|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
356134|NCT00739908|E2|Reported Event|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
356135|NCT00739908|E1|Reported Event|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
356136|NCT00739882|B3|Baseline|Total|Total of all reporting groups
356137|NCT00739882|B2|Baseline|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356138|NCT00739882|B1|Baseline|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356139|NCT00739882|P2|Participant Flow|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356140|NCT00739882|P1|Participant Flow|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356141|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356142|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356143|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356144|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356145|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356146|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356147|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356172|NCT00739765|E1|Reported Event|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
356173|NCT00739674|B3|Baseline|Total|Total of all reporting groups
356237|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356148|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356149|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356150|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356151|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
356152|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
356153|NCT00739882|E4|Reported Event|Placebo - Open-label Period|
356154|NCT00739882|E3|Reported Event|Efalizumab - Open-label Period|
356155|NCT00739882|E2|Reported Event|Placebo - Double-blind Period|
356156|NCT00739882|E1|Reported Event|Efalizumab - Double-blind Period|
356157|NCT00739765|B4|Baseline|Total|Total of all reporting groups
356158|NCT00739765|B3|Baseline|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
356159|NCT00739765|B2|Baseline|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
356160|NCT00739765|B1|Baseline|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
356161|NCT00739765|P3|Participant Flow|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
356162|NCT00739765|P2|Participant Flow|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
356163|NCT00739765|P1|Participant Flow|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
356164|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
356165|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
356166|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
356167|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
356168|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
356169|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
356170|NCT00739765|E3|Reported Event|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
356171|NCT00739765|E2|Reported Event|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
356235|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356174|NCT00739674|B2|Baseline|Diet Management and Losartan-Based Regimen (DML Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
356175|NCT00739674|B1|Baseline|Losartan-Based Regimen Alone (L Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
356176|NCT00739674|P2|Participant Flow|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
356177|NCT00739674|P1|Participant Flow|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
356178|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356179|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356180|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356181|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356182|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356183|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356184|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356185|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356186|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356187|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356188|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356189|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356190|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356191|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356192|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356193|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356194|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356195|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356196|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356197|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356236|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356951|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356198|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356199|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356200|NCT00739674|E2|Reported Event|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
356201|NCT00739674|E1|Reported Event|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
356202|NCT00739661|B3|Baseline|Total|Total of all reporting groups
356203|NCT00739661|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356204|NCT00739661|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356205|NCT00739661|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356206|NCT00739661|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356207|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356208|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356209|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356210|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356211|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356212|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356213|NCT00739661|E2|Reported Event|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356214|NCT00739661|E1|Reported Event|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
356215|NCT00739648|B3|Baseline|Total|Total of all reporting groups
356216|NCT00739648|B2|Baseline|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356217|NCT00739648|B1|Baseline|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356218|NCT00739648|P2|Participant Flow|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356219|NCT00739648|P1|Participant Flow|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356220|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
356221|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
356222|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
356223|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
356224|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356225|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356226|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily (BID)via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
356227|NCT00739648|O1|Outcome|Placebo|Placebo inhaled twice daily (BID) via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
356228|NCT00739648|E2|Reported Event|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356229|NCT00739648|E1|Reported Event|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
356230|NCT00739596|B3|Baseline|Total|Total of all reporting groups
356231|NCT00739596|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356232|NCT00739596|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356233|NCT00739596|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356234|NCT00739596|P1|Participant Flow|Aliskiren Hydrochlorothiazide (HCTZ)|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
359280|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
356238|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356239|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356240|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356241|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356242|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356243|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
356244|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
356245|NCT00739596|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks.
356246|NCT00739596|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks.
356247|NCT00739583|B3|Baseline|Total|Total of all reporting groups
356248|NCT00739583|B2|Baseline|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356249|NCT00739583|B1|Baseline|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356250|NCT00739583|P2|Participant Flow|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356251|NCT00739583|P1|Participant Flow|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356252|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356253|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356254|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356255|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356256|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356257|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356258|NCT00739583|E2|Reported Event|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
356259|NCT00739583|E1|Reported Event|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
356260|NCT00739336|B3|Baseline|Total|Total of all reporting groups
356261|NCT00739336|B2|Baseline|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356262|NCT00739336|B1|Baseline|Intervention|"A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.~Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings."
356263|NCT00739336|P2|Participant Flow|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356264|NCT00739336|P1|Participant Flow|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356265|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356266|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356267|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356268|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356269|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356270|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356271|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356272|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356273|NCT00739336|E2|Reported Event|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
356952|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
356274|NCT00739336|E1|Reported Event|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
356275|NCT00739310|B1|Baseline|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
356276|NCT00739310|P1|Participant Flow|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
356277|NCT00739310|O2|Outcome|Post Vest Treatment|12 months of intervention 2 x daily Vest Therapy
356278|NCT00739310|O1|Outcome|Pre-Treatment|Prior to Vest Treatment
356279|NCT00739310|E1|Reported Event|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
356280|NCT00739297|B1|Baseline|All Participants|Combined participants from all arms.
356281|NCT00739297|P7|Participant Flow|Total|"Consistent with the incomplete-block design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not~received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period."
356282|NCT00739297|P6|Participant Flow|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356283|NCT00739297|P5|Participant Flow|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356284|NCT00739297|P4|Participant Flow|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356285|NCT00739297|P3|Participant Flow|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356286|NCT00739297|P2|Participant Flow|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356287|NCT00739297|P1|Participant Flow|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356288|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356289|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356290|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356291|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356292|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
359281|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
356293|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356294|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356295|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356296|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356297|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356298|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356299|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356300|NCT00739297|O2|Outcome|Montelukast+ Placebo|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Placebo for Albuterol (data for each patient are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
356301|NCT00739297|O1|Outcome|Montelukast+Albuterol|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Albuterol (data for each patient are pooled across all 3 administrations of active albuterol, as added to active montelukast)
356302|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356303|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356304|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356305|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356306|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356307|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356324|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356308|NCT00739297|E6|Reported Event|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356309|NCT00739297|E5|Reported Event|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356310|NCT00739297|E4|Reported Event|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356311|NCT00739297|E3|Reported Event|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356312|NCT00739297|E2|Reported Event|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356313|NCT00739297|E1|Reported Event|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
356314|NCT00739102|B1|Baseline|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356315|NCT00739102|P1|Participant Flow|S.M.A.R.T.® Nitinol Stent System|The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356316|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356317|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356318|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356319|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356320|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356321|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356322|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356323|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356684|NCT00737594|P3|Participant Flow|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
356325|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356326|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356327|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356328|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356329|NCT00739102|E1|Reported Event|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
356330|NCT00739063|B1|Baseline|Tarceva Daily|Tarceva oral 150 mg daily.
356331|NCT00739063|P1|Participant Flow|Tarceva Daily|Tarceva oral 150 mg daily.
356332|NCT00739063|O1|Outcome|Tarceva Daily|Tarceva oral 150 mg daily.
356333|NCT00739063|E1|Reported Event|Tarceva Daily|Tarceva oral 150 mg daily.
356334|NCT00739050|B1|Baseline|All Participants|"All Randomized patients.~Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)"
356335|NCT00739050|P2|Participant Flow|Placebo|Placebo daily at nights for 12 weeks
356336|NCT00739050|P1|Participant Flow|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356337|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
356338|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356339|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
356340|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356341|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
356342|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356343|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
356344|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356345|NCT00739050|E2|Reported Event|Placebo|Placebo daily at nights for 12 weeks
356346|NCT00739050|E1|Reported Event|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
356347|NCT00739024|B3|Baseline|Total|Total of all reporting groups
356348|NCT00739024|B2|Baseline|Placebo|Random assignment to placebo
356349|NCT00739024|B1|Baseline|Active Treatment|Random assignment to active treatment
356350|NCT00739024|P2|Participant Flow|Placebo|Random assignment to placebo
356351|NCT00739024|P1|Participant Flow|Active Treatment|Random assignment to active treatment
356352|NCT00739024|O2|Outcome|Placebo|Random assignment to placebo
356353|NCT00739024|O1|Outcome|Active Treatment|Random assignment to active treatment
356354|NCT00739024|E2|Reported Event|Placebo|Random assignment to placebo
356355|NCT00739024|E1|Reported Event|Active Treatment|Random assignment to active treatment
356356|NCT00738972|B5|Baseline|Total|Total of all reporting groups
356357|NCT00738972|B4|Baseline|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
356358|NCT00738972|B3|Baseline|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
356359|NCT00738972|B2|Baseline|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
356360|NCT00738972|B1|Baseline|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
356361|NCT00738972|P4|Participant Flow|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
356362|NCT00738972|P3|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
356363|NCT00738972|P2|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
356364|NCT00738972|P1|Participant Flow|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
356365|NCT00738972|O4|Outcome|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
356366|NCT00738972|O3|Outcome|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
356367|NCT00738972|O2|Outcome|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
356368|NCT00738972|O1|Outcome|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
356369|NCT00738972|E4|Reported Event|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
356370|NCT00738972|E3|Reported Event|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
356371|NCT00738972|E2|Reported Event|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
356372|NCT00738972|E1|Reported Event|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
356373|NCT00738881|B3|Baseline|Total|Total of all reporting groups
356374|NCT00738881|B2|Baseline|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356375|NCT00738881|B1|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356376|NCT00738881|P2|Participant Flow|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356377|NCT00738881|P1|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356378|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356379|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356380|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356381|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356382|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356383|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356384|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
356385|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
356386|NCT00738881|E2|Reported Event|Arm II|pemetrexed disodium: Given IV
356387|NCT00738881|E1|Reported Event|Arm I|erlotinib hydrochloride: Given orally
356388|NCT00738673|B3|Baseline|Total|Total of all reporting groups
356389|NCT00738673|B2|Baseline|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356390|NCT00738673|B1|Baseline|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356391|NCT00738673|P2|Participant Flow|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356392|NCT00738673|P1|Participant Flow|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356393|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356394|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356395|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356396|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356397|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356398|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356399|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356400|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356401|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356402|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356403|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356404|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356405|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356406|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356407|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356408|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356409|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356410|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356411|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356412|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356413|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356414|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356415|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356416|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356417|NCT00738673|E2|Reported Event|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356418|NCT00738673|E1|Reported Event|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
356419|NCT00738543|B1|Baseline|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356420|NCT00738543|P1|Participant Flow|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356421|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356422|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356423|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356424|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356425|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356426|NCT00738543|E1|Reported Event|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
356427|NCT00738530|B3|Baseline|Total|Total of all reporting groups
356685|NCT00737594|P2|Participant Flow|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
359282|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
356428|NCT00738530|B2|Baseline|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356429|NCT00738530|B1|Baseline|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356430|NCT00738530|P2|Participant Flow|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356431|NCT00738530|P1|Participant Flow|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) was administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
356432|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356433|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356434|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356435|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356436|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356437|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356438|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356439|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356440|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356441|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356442|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356443|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356444|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356445|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356446|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356447|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356547|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356448|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356449|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356450|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356451|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356452|NCT00738530|E2|Reported Event|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356453|NCT00738530|E1|Reported Event|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
356454|NCT00738426|B3|Baseline|Total|Total of all reporting groups
356455|NCT00738426|B2|Baseline|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
356456|NCT00738426|B1|Baseline|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
356457|NCT00738426|P2|Participant Flow|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
356458|NCT00738426|P1|Participant Flow|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
356459|NCT00738426|O2|Outcome|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
356460|NCT00738426|O1|Outcome|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
356461|NCT00738426|E2|Reported Event|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
356462|NCT00738426|E1|Reported Event|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
356463|NCT00738400|B3|Baseline|Total|Total of all reporting groups
356464|NCT00738400|B2|Baseline|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356465|NCT00738400|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356466|NCT00738400|P2|Participant Flow|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356467|NCT00738400|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356468|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356469|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356470|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356471|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356472|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356473|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356474|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356475|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356476|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356477|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356478|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356479|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356480|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356481|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356482|NCT00738400|E2|Reported Event|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
356483|NCT00738400|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
356484|NCT00738374|B4|Baseline|Total|Total of all reporting groups
356544|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356485|NCT00738374|B3|Baseline|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356486|NCT00738374|B2|Baseline|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356487|NCT00738374|B1|Baseline|CLB + R: Not Randomized|Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
356488|NCT00738374|P4|Participant Flow|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356489|NCT00738374|P3|Participant Flow|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356490|NCT00738374|P2|Participant Flow|CLB + R: Completed Induction Treament But Not Randomized|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
356491|NCT00738374|P1|Participant Flow|Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
356492|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356493|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356494|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356495|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356496|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
359283|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
356497|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356498|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356499|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356500|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356501|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356502|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356503|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356504|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356505|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356506|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356507|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356545|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356508|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356509|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356510|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356511|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356512|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
356513|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356514|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356515|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
356516|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356517|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356518|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356519|NCT00738374|E3|Reported Event|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
356546|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356676|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
359284|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
356520|NCT00738374|E2|Reported Event|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
356521|NCT00738374|E1|Reported Event|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
356522|NCT00738361|B1|Baseline|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
356523|NCT00738361|P1|Participant Flow|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
356524|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
356525|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
356526|NCT00738361|O1|Outcome|Nab-paclitaxel|"Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.~nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days."
356527|NCT00738361|E1|Reported Event|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
356528|NCT00738283|B1|Baseline|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
356529|NCT00738283|P1|Participant Flow|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
356530|NCT00738283|O1|Outcome|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
356531|NCT00738283|E1|Reported Event|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
356532|NCT00738062|B4|Baseline|Total|Total of all reporting groups
356533|NCT00738062|B3|Baseline|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356534|NCT00738062|B2|Baseline|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356535|NCT00738062|B1|Baseline|Open-Label Droxidopa|Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
356536|NCT00738062|P3|Participant Flow|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356537|NCT00738062|P2|Participant Flow|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356538|NCT00738062|P1|Participant Flow|Open-Label Droxidopa|3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
356539|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356540|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356541|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356542|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356543|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356548|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356549|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356550|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356551|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356552|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356553|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356554|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356555|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356556|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356557|NCT00738062|E5|Reported Event|Total Droxidopa|All Patients exposed to droxidopa
356558|NCT00738062|E4|Reported Event|Long-Term Follow-up|Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
356559|NCT00738062|E3|Reported Event|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356560|NCT00738062|E2|Reported Event|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
356561|NCT00738062|E1|Reported Event|Three Month Open-Label Droxidopa|all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
356562|NCT00738049|B3|Baseline|Total|Total of all reporting groups
356563|NCT00738049|B2|Baseline|Group 2|Group 2 received placebo during Phase 1 then oral Darusentan 100 mg during Phase 2.
356564|NCT00738049|B1|Baseline|Group 1|Group 1 received oral Darusentan 100mg during Phase 1 then placebo during Phase 2.
356565|NCT00738049|P2|Participant Flow|Placebo, Then Darusentan 100mg|Patients were randomized to oral placebo for 14 days, then underwent PET imaging. Study patients then received Darusentan 100mg for 14 days. The patients underwent cardiac PET imaging followed by a 14 day washout period and final PET scan. Patients and physicians were blinded to medication assignment.
356566|NCT00738049|P1|Participant Flow|Darusentan Then Placebo,|Patients were randomized to oral Darusentan 100mg for 14 days and then underwent cardiac PET imaging. They then received placebo for 14 days and underwent PET imaging, followed by a washout period of 14 days and completed the final cardiac PET scan. Patients and physicians were blinded to medication assignment.
356567|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a assessment of CFR while receiving darusentan
356568|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of CFR before receiving darusentan or placebo
356569|NCT00738049|O4|Outcome|Baseline at Hyperemia|All patients underwent a baseline assessment of hyperemic flow before receiving darusentan or placebo
356570|NCT00738049|O3|Outcome|Baseline at Rest|All patients underwent a baseline assessment of resting flow before receiving darusentan or placebo
356571|NCT00738049|O2|Outcome|Darusentan 100mg at Hyperemia|All patients underwent assessment of hyperemic flow while receiving darusentan
356572|NCT00738049|O1|Outcome|Darusentan 100mg at Rest|All patients underwent assessment of rest flow while receiving darusentan
356573|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a baseline assessment of Markovian homogeneity while taking darusentan
356574|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of Markovian homogeneity before receiving darusentan or placebo
356575|NCT00738049|E2|Reported Event|Group 2|Received placebo during Phase 1, Darusentan 100mg during Phase 2
356576|NCT00738049|E1|Reported Event|Group 1|Darusentan 100mg during Phase 1, Placebo during Phase 2
356577|NCT00738023|B3|Baseline|Total|Total of all reporting groups
356578|NCT00738023|B2|Baseline|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
356579|NCT00738023|B1|Baseline|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
356580|NCT00738023|P2|Participant Flow|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
356581|NCT00738023|P1|Participant Flow|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
356677|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
356686|NCT00737594|P1|Participant Flow|Placebo|Placebo: 0 mcg capsules three times daily (TID)
356582|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
356583|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
356584|NCT00738023|O2|Outcome|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
356585|NCT00738023|O1|Outcome|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
356586|NCT00738023|E2|Reported Event|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
356587|NCT00738023|E1|Reported Event|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
356588|NCT00737737|B3|Baseline|Total|Total of all reporting groups
356589|NCT00737737|B2|Baseline|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
356590|NCT00737737|B1|Baseline|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
356591|NCT00737737|P2|Participant Flow|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
356592|NCT00737737|P1|Participant Flow|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
356593|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
356594|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
356595|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
356596|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
356597|NCT00737737|E2|Reported Event|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
356598|NCT00737737|E1|Reported Event|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
356599|NCT00737711|B1|Baseline|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356600|NCT00737711|P1|Participant Flow|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356601|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356602|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356603|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356604|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356605|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356606|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356607|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356608|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356678|NCT00737633|E2|Reported Event|72-week Population|subjects who were randomized to active during previous study
356679|NCT00737633|E1|Reported Event|16-week Population|subjects who were randomized to placebo in previous study
356609|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356610|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356611|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356612|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356613|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356614|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356615|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356616|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356617|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356618|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356619|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356620|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356621|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356622|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356623|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356624|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356625|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356626|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356627|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356628|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356629|NCT00737711|E1|Reported Event|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
356630|NCT00737672|B3|Baseline|Total|Total of all reporting groups
356631|NCT00737672|B2|Baseline|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis."
356632|NCT00737672|B1|Baseline|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis."
356633|NCT00737672|P2|Participant Flow|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356680|NCT00737594|B4|Baseline|Total|Total of all reporting groups
356681|NCT00737594|B3|Baseline|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
356634|NCT00737672|P1|Participant Flow|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356635|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356636|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356637|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356638|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356639|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356640|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356641|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356642|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356643|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356644|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356645|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356646|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356647|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356648|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356649|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356650|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356651|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356682|NCT00737594|B2|Baseline|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
356683|NCT00737594|B1|Baseline|Placebo|Placebo: 0 mcg capsules three times daily (TID)
359285|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
356652|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356653|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356654|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356655|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356656|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356657|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356658|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356659|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356660|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356661|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356662|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356663|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356664|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356665|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
356666|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
356667|NCT00737672|E2|Reported Event|PTA Treatment Group|Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
356668|NCT00737672|E1|Reported Event|VIABAHN Treatment Group|Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
356669|NCT00737633|B3|Baseline|Total|Total of all reporting groups
356670|NCT00737633|B2|Baseline|72-week Population|subjects who were randomized to active during previous study
356671|NCT00737633|B1|Baseline|16-week Population|subjects who were randomized to placebo in previous study
356672|NCT00737633|P2|Participant Flow|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
356673|NCT00737633|P1|Participant Flow|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
356674|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
356675|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
356687|NCT00737594|O3|Outcome|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
356688|NCT00737594|O2|Outcome|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
356689|NCT00737594|O1|Outcome|Placebo|Placebo: 0 mcg capsules three times daily (TID)
356690|NCT00737594|E3|Reported Event|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
356691|NCT00737594|E2|Reported Event|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
356692|NCT00737594|E1|Reported Event|Placebo|Placebo: 0 mcg capsules three times daily (TID)
356693|NCT00737568|B3|Baseline|Total|Total of all reporting groups
356694|NCT00737568|B2|Baseline|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356695|NCT00737568|B1|Baseline|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356696|NCT00737568|P2|Participant Flow|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356697|NCT00737568|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
356698|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356699|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356700|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356701|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356702|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356703|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356704|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356705|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356706|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356707|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356708|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356709|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356710|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356711|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356712|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356713|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356714|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356715|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356716|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356717|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356718|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356719|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356720|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356721|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356722|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356723|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356724|NCT00737568|E2|Reported Event|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
356725|NCT00737568|E1|Reported Event|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
356726|NCT00737529|B1|Baseline|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
356727|NCT00737529|P1|Participant Flow|Lenalidomide|"Single agent lenalidomide~Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal."
356728|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356729|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356730|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356731|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356732|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356733|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356734|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356735|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356736|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356737|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356738|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
356739|NCT00737529|E1|Reported Event|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
356740|NCT00737477|B1|Baseline|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356741|NCT00737477|P1|Participant Flow|Mircera in Chronic Kidney Disease (CKD)-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356789|NCT00737282|B2|Baseline|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356790|NCT00737282|B1|Baseline|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
359286|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
356742|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356743|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356744|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356745|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356746|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356747|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356748|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356749|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356750|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356751|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356752|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356753|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356833|NCT00737100|B1|Baseline|Placebo|Patients randomised to receive matching placebo
357060|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
356754|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356755|NCT00737477|E1|Reported Event|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
356756|NCT00737464|B1|Baseline|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356757|NCT00737464|P1|Participant Flow|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356758|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356759|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356760|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356761|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356762|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356763|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356764|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356765|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356766|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356767|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356768|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356769|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356770|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356771|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356772|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356773|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356774|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356775|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356776|NCT00737464|E1|Reported Event|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
356777|NCT00737438|B1|Baseline|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
356778|NCT00737438|P1|Participant Flow|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
356779|NCT00737438|O1|Outcome|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
356780|NCT00737438|E1|Reported Event|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
356781|NCT00737360|B1|Baseline|TAS-106|
356782|NCT00737360|P1|Participant Flow|TAS-106|
356783|NCT00737360|O1|Outcome|TAS-106|
356784|NCT00737360|O1|Outcome|TAS-106|
356785|NCT00737360|O1|Outcome|TAS-106|
356786|NCT00737360|O1|Outcome|TAS-106|
356787|NCT00737360|E1|Reported Event|TAS-106|
356788|NCT00737282|B3|Baseline|Total|Total of all reporting groups
356791|NCT00737282|P1|Participant Flow|Proellex|"Proellex 25 or 50 mg once daily~One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356792|NCT00737282|O2|Outcome|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356793|NCT00737282|O1|Outcome|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356794|NCT00737282|E2|Reported Event|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356795|NCT00737282|E1|Reported Event|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
356796|NCT00737243|B1|Baseline|Patients With Tumor Assays Performed|Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.
356797|NCT00737243|P1|Participant Flow|All Patients With a Successful Tumor Assays Performed|Subjects in this group had a successful molecular assay of biopsy tissue
356798|NCT00737243|O1|Outcome|Patients With Successful Tumor Assays Performed|In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.
356799|NCT00737243|O2|Outcome|Less Treatment Responsive|Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months
356800|NCT00737243|O1|Outcome|More Treatment Responsive|Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.
356801|NCT00737243|E1|Reported Event|All Treated Patients|
356802|NCT00737204|B3|Baseline|Total|Total of all reporting groups
356803|NCT00737204|B2|Baseline|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356804|NCT00737204|B1|Baseline|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356805|NCT00737204|P2|Participant Flow|Placebo|Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
356806|NCT00737204|P1|Participant Flow|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
356807|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356808|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356809|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356810|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356811|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356812|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356813|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356814|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356815|NCT00737204|E2|Reported Event|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
356816|NCT00737204|E1|Reported Event|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
356817|NCT00737178|B3|Baseline|Total|Total of all reporting groups
356818|NCT00737178|B2|Baseline|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356819|NCT00737178|B1|Baseline|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356820|NCT00737178|P2|Participant Flow|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356821|NCT00737178|P1|Participant Flow|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356822|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356823|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356824|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356825|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356826|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356827|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356828|NCT00737178|E2|Reported Event|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
356829|NCT00737178|E1|Reported Event|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
356830|NCT00737100|B4|Baseline|Total|Total of all reporting groups
356831|NCT00737100|B3|Baseline|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356832|NCT00737100|B2|Baseline|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356834|NCT00737100|P3|Participant Flow|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356835|NCT00737100|P2|Participant Flow|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356836|NCT00737100|P1|Participant Flow|Placebo|Patients randomised to receive matching placebo
356837|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356838|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356839|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356840|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356841|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356842|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356843|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356844|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356845|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356846|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356847|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356848|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356849|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356850|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356851|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356852|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356853|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356854|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356855|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356856|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356857|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356858|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356859|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356860|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356861|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356862|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356863|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356864|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356865|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356866|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356867|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356868|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356869|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356870|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356871|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356872|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356873|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356874|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356875|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
356876|NCT00737100|E3|Reported Event|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
356877|NCT00737100|E2|Reported Event|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
356878|NCT00737100|E1|Reported Event|Placebo|Patients randomised to receive matching placebo
356879|NCT00737061|B1|Baseline|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356880|NCT00737061|P1|Participant Flow|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356881|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356882|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356883|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356884|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356885|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356886|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356887|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356888|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356889|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356890|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356891|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356892|NCT00737061|E1|Reported Event|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
356893|NCT00737048|B4|Baseline|Total|Total of all reporting groups
356894|NCT00737048|B3|Baseline|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356895|NCT00737048|B2|Baseline|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356896|NCT00737048|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356897|NCT00737048|P3|Participant Flow|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356898|NCT00737048|P2|Participant Flow|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356899|NCT00737048|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356900|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356901|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356902|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356903|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356904|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356905|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356906|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356907|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356908|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
359287|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
356909|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356910|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356911|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356912|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356913|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356914|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356915|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356916|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356917|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356918|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356919|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356920|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356921|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356922|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356923|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356924|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356925|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356950|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356926|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356927|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356928|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356929|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356930|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356931|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356932|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356933|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356934|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356935|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356936|NCT00737048|E3|Reported Event|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356937|NCT00737048|E2|Reported Event|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356938|NCT00737048|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
356939|NCT00736996|B4|Baseline|Total|Total of all reporting groups
356940|NCT00736996|B3|Baseline|Placebo|Placebo: Matching oral tablet daily for 6 months
356941|NCT00736996|B2|Baseline|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356942|NCT00736996|B1|Baseline|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356943|NCT00736996|P3|Participant Flow|Placebo|Placebo: Matching oral tablet daily for 6 months
356944|NCT00736996|P2|Participant Flow|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356945|NCT00736996|P1|Participant Flow|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356946|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
356947|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356948|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356949|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
356953|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356954|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356955|NCT00736996|E3|Reported Event|Placebo|Placebo: Matching oral tablet daily for 6 months
356956|NCT00736996|E2|Reported Event|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
356957|NCT00736996|E1|Reported Event|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
356958|NCT00736957|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356959|NCT00736957|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356960|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356961|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356962|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356963|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356964|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356965|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356966|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356967|NCT00736957|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
356968|NCT00736944|B1|Baseline|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356969|NCT00736944|P1|Participant Flow|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
357024|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357025|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357191|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
356970|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356971|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356972|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356973|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356974|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356975|NCT00736944|O3|Outcome|FDG-PET/CT|
356976|NCT00736944|O2|Outcome|CT Scan|
356977|NCT00736944|O1|Outcome|Clinical Examination|
356978|NCT00736944|O3|Outcome|FDG-PET/CT|
356979|NCT00736944|O2|Outcome|CT Scan|
356980|NCT00736944|O1|Outcome|Clinical Examination|
356981|NCT00736944|O3|Outcome|FDG-PET/CT|
356982|NCT00736944|O2|Outcome|CT Scan|
356983|NCT00736944|O1|Outcome|Clinical Examination|
356984|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356985|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356986|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356987|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356988|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356989|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356990|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356991|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356992|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356993|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356994|NCT00736944|E1|Reported Event|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
356995|NCT00736879|B5|Baseline|Total|Total of all reporting groups
356996|NCT00736879|B4|Baseline|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
356997|NCT00736879|B3|Baseline|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
356998|NCT00736879|B2|Baseline|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
356999|NCT00736879|B1|Baseline|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357000|NCT00736879|P4|Participant Flow|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357001|NCT00736879|P3|Participant Flow|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357002|NCT00736879|P2|Participant Flow|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357003|NCT00736879|P1|Participant Flow|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357004|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357005|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357006|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357007|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357008|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357009|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357010|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357011|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357012|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357013|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357014|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357015|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357016|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357017|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357018|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357019|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357020|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357021|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357022|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357023|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357026|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357027|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357028|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357029|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357030|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357031|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357032|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357033|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357034|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357035|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357036|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357037|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357038|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357039|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357040|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357041|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357042|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357043|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357044|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357045|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357046|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357047|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357048|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357049|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357050|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357051|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357052|NCT00736879|E4|Reported Event|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357053|NCT00736879|E3|Reported Event|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357054|NCT00736879|E2|Reported Event|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357055|NCT00736879|E1|Reported Event|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
357056|NCT00736853|B1|Baseline|Entire Study Population|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.
357057|NCT00736853|P3|Participant Flow|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357058|NCT00736853|P2|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357059|NCT00736853|P1|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357061|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357062|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357063|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357064|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357065|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357066|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357067|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357068|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357069|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357070|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357071|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357072|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357073|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357074|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357075|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357076|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357077|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357078|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357079|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357080|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357081|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357082|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357083|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357084|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357085|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357086|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357087|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357088|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357124|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357125|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357089|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357090|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357091|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357092|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357093|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357094|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357095|NCT00736853|E3|Reported Event|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
357096|NCT00736853|E2|Reported Event|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
357097|NCT00736853|E1|Reported Event|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
357098|NCT00736840|B1|Baseline|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
357099|NCT00736840|P1|Participant Flow|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
357100|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
357101|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
357102|NCT00736840|E1|Reported Event|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
357103|NCT00736723|B3|Baseline|Total|Total of all reporting groups
357104|NCT00736723|B2|Baseline|Postoperative/Posttraumatic Patients With Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
357105|NCT00736723|B1|Baseline|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
357106|NCT00736723|P2|Participant Flow|Patients With Septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
357107|NCT00736723|P1|Participant Flow|Patients With Non-septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock
357108|NCT00736723|O2|Outcome|Patients Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
357109|NCT00736723|O1|Outcome|Patients Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
357110|NCT00736723|E2|Reported Event|Postoperative/Posttraumatic Patients With Septi|Postoperative/posttraumatic critically ill patients with septic shock
357111|NCT00736723|E1|Reported Event|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
357112|NCT00736580|B3|Baseline|Total|Total of all reporting groups
357113|NCT00736580|B2|Baseline|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
357114|NCT00736580|B1|Baseline|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
357115|NCT00736580|P2|Participant Flow|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
357116|NCT00736580|P1|Participant Flow|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
357117|NCT00736580|O2|Outcome|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
357118|NCT00736580|O1|Outcome|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
357119|NCT00736580|E2|Reported Event|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
357120|NCT00736580|E1|Reported Event|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
357121|NCT00736502|B1|Baseline|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357122|NCT00736502|P1|Participant Flow|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357123|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357455|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357126|NCT00736502|E1|Reported Event|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
357127|NCT00736489|B1|Baseline|Baseline Total|Total number of patients randomized and treated in the study
357128|NCT00736489|P6|Participant Flow|PEBCDAa|Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg.
357129|NCT00736489|P5|Participant Flow|EDABCPa|Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo.
357130|NCT00736489|P4|Participant Flow|DCPABEa|Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg.
357131|NCT00736489|P3|Participant Flow|CBEPADa|AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg .
357132|NCT00736489|P2|Participant Flow|BADEPCa|AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg.
357133|NCT00736489|P1|Participant Flow|APCDEBa|AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg.
357134|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357135|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357136|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357137|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357138|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357139|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357140|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357141|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357142|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357143|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357144|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357145|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357146|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357147|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357148|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357149|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357150|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357151|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357152|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357153|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357154|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357155|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357156|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357157|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357158|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357159|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357160|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357161|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357162|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357163|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357164|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357165|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357166|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357167|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357168|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357169|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357170|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357171|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357172|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357173|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357174|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357175|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357176|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357177|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357178|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357179|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357180|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357181|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357182|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357183|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357184|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357185|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357186|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357187|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357188|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357189|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357190|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357192|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357193|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357194|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357195|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357196|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357197|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357198|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357199|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357200|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357201|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357202|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357203|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357204|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357205|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357206|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357207|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357208|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357209|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357210|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357211|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357212|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357213|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357214|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357215|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357216|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357217|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357218|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357219|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357220|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357221|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357222|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357223|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357224|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357225|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357226|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357227|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357228|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357229|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357230|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357231|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357232|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357233|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357234|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357235|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357236|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357237|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357238|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357239|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357240|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357241|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357242|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357243|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357244|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357245|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357246|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357247|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357248|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357249|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357250|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357251|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357252|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357253|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357254|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357255|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357256|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357257|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357258|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357259|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357260|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357261|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357262|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357263|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357264|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357265|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357266|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357267|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357268|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357269|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357270|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357271|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357272|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
357273|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357274|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357275|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357276|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357277|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357278|NCT00736489|E6|Reported Event|Placebo|Placebo inhaled via Turbuhaler
357279|NCT00736489|E5|Reported Event|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
357280|NCT00736489|E4|Reported Event|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
357281|NCT00736489|E3|Reported Event|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
357282|NCT00736489|E2|Reported Event|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
357283|NCT00736489|E1|Reported Event|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
357284|NCT00736385|B3|Baseline|Total|Total of all reporting groups
357285|NCT00736385|B2|Baseline|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357286|NCT00736385|B1|Baseline|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357287|NCT00736385|P2|Participant Flow|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357288|NCT00736385|P1|Participant Flow|Metformin|"Metformin XR (extended-release) 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357289|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357290|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357291|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357292|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357293|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357294|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357295|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357296|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357297|NCT00736385|E2|Reported Event|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
357298|NCT00736385|E1|Reported Event|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
357299|NCT00736333|B1|Baseline|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357300|NCT00736333|P1|Participant Flow|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357301|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357302|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357303|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357304|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357305|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357306|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357307|NCT00736333|E1|Reported Event|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
357308|NCT00736255|B3|Baseline|Total|Total of all reporting groups
357309|NCT00736255|B2|Baseline|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357310|NCT00736255|B1|Baseline|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357311|NCT00736255|P2|Participant Flow|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357312|NCT00736255|P1|Participant Flow|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357313|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357314|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357315|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357316|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357317|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357318|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357319|NCT00736255|E2|Reported Event|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
357320|NCT00736255|E1|Reported Event|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
357321|NCT00736242|B1|Baseline|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357322|NCT00736242|P1|Participant Flow|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357323|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357324|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357325|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357326|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357327|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357328|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357329|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357330|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357331|NCT00736242|E1|Reported Event|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
357332|NCT00736229|B4|Baseline|Total|Total of all reporting groups
357333|NCT00736229|B3|Baseline|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
357334|NCT00736229|B2|Baseline|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
357335|NCT00736229|B1|Baseline|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357336|NCT00736229|P3|Participant Flow|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
357337|NCT00736229|P2|Participant Flow|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
357338|NCT00736229|P1|Participant Flow|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357339|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357340|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
357341|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
357342|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357343|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
357344|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
357345|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357346|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
357347|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
357348|NCT00736229|O1|Outcome|Exenatide|Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357349|NCT00736229|E1|Reported Event|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
357350|NCT00736190|B1|Baseline|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
357351|NCT00736190|P1|Participant Flow|A: TDF|Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily
357352|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357353|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357354|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357355|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357356|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357357|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357358|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357359|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357360|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357361|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
357362|NCT00736190|E1|Reported Event|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
357363|NCT00736125|B3|Baseline|Total|Total of all reporting groups
357364|NCT00736125|B2|Baseline|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
357365|NCT00736125|B1|Baseline|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
357366|NCT00736125|P2|Participant Flow|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
357367|NCT00736125|P1|Participant Flow|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
357368|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
357369|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
357370|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
357371|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
357372|NCT00736125|E2|Reported Event|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
357373|NCT00736125|E1|Reported Event|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
357374|NCT00736099|B3|Baseline|Total|Total of all reporting groups
357375|NCT00736099|B2|Baseline|New Lina|Patients pre-treated with placebo
357376|NCT00736099|B1|Baseline|Old Lina|Patients pre-treated with linagliptin
357377|NCT00736099|P2|Participant Flow|New Lina|Patients pre-treated with placebo
357378|NCT00736099|P1|Participant Flow|Old Lina|Patients pre-treated with linagliptin (BI 1356)
357379|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357380|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357381|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357382|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357383|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357384|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357385|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357386|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357387|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357388|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357389|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357390|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357391|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357392|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357393|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357394|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357395|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357396|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357397|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357398|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357399|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357400|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357401|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357402|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357403|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357404|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357405|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357406|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357407|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357408|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357409|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357410|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357411|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357412|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357413|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357414|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357415|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357416|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357417|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357418|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357419|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357420|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357421|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357422|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357423|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357424|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357425|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357426|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357427|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357428|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357429|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357430|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357431|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357432|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357433|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357434|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357435|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357436|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357437|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357438|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357439|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357440|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357441|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357442|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357443|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357444|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357445|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357446|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357447|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357448|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357449|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357450|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357451|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357452|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357453|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357454|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357456|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357457|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357458|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357459|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357460|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357461|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357462|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357463|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357464|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357465|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357466|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357467|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357468|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357469|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
357470|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
357471|NCT00736099|E2|Reported Event|New Lina|Patients pre-treated with placebo
357472|NCT00736099|E1|Reported Event|Old Lina|Patients pre-treated with linagliptin
357473|NCT00736073|B3|Baseline|Total|Total of all reporting groups
357474|NCT00736073|B2|Baseline|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357475|NCT00736073|B1|Baseline|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357476|NCT00736073|P2|Participant Flow|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357477|NCT00736073|P1|Participant Flow|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357478|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357479|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357480|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357481|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357482|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357483|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357484|NCT00736073|E2|Reported Event|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357485|NCT00736073|E1|Reported Event|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
357486|NCT00736034|B1|Baseline|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
357487|NCT00736034|P1|Participant Flow|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
357488|NCT00736034|O1|Outcome|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
357489|NCT00736034|E1|Reported Event|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
357490|NCT00735969|B1|Baseline|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
357491|NCT00735969|P1|Participant Flow|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
357492|NCT00735969|O1|Outcome|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
357493|NCT00735969|E1|Reported Event|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
357494|NCT00735943|B1|Baseline|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357495|NCT00735943|P1|Participant Flow|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357496|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357497|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
358103|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
357498|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357499|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357500|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357501|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357502|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357503|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357504|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357505|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357506|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357507|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357508|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357509|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357510|NCT00735943|E1|Reported Event|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
357511|NCT00735917|B1|Baseline|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357512|NCT00735917|P1|Participant Flow|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357513|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357514|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357515|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357516|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357517|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357518|NCT00735917|E1|Reported Event|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
357519|NCT00735904|B1|Baseline|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357520|NCT00735904|P1|Participant Flow|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357521|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357522|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357523|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357524|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357596|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357525|NCT00735904|E1|Reported Event|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
357526|NCT00735839|B3|Baseline|Total|Total of all reporting groups
357527|NCT00735839|B2|Baseline|Placebo|Placebo single dose on Day 1
357528|NCT00735839|B1|Baseline|V710|V710 vaccination (60 mcg) single dose on Day 1
357529|NCT00735839|P2|Participant Flow|Placebo|Placebo single dose on Day 1
357530|NCT00735839|P1|Participant Flow|V710|V710 vaccination (60 mcg) single dose on Day 1
357531|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
357532|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
357533|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
357534|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
357535|NCT00735839|E2|Reported Event|Placebo|Placebo single dose on Day 1
357536|NCT00735839|E1|Reported Event|V710|V710 vaccination (60 mcg) single dose on Day 1
357537|NCT00735787|B3|Baseline|Total|Total of all reporting groups
357538|NCT00735787|B2|Baseline|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357539|NCT00735787|B1|Baseline|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357540|NCT00735787|P2|Participant Flow|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357541|NCT00735787|P1|Participant Flow|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357542|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357543|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357544|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357545|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357546|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357547|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357548|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357549|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357550|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357551|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357552|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357553|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357554|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357555|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357556|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357557|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357558|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357559|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357560|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
359288|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
357561|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357562|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357563|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357564|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357565|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357566|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357567|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357568|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357569|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357570|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357571|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357572|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357573|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357574|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357575|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357576|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357577|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357578|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357579|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357580|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357581|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357582|NCT00735787|E2|Reported Event|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
357583|NCT00735787|E1|Reported Event|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
357584|NCT00735709|B5|Baseline|Total|Total of all reporting groups
357585|NCT00735709|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357586|NCT00735709|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357587|NCT00735709|B2|Baseline|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357588|NCT00735709|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357589|NCT00735709|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357590|NCT00735709|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357591|NCT00735709|P2|Participant Flow|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357592|NCT00735709|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357593|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357594|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357595|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357597|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357598|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357599|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357600|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357601|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357602|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357603|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357604|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357605|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357606|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357607|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357608|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357609|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357610|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357611|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357612|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357613|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357614|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357615|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357616|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357617|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357618|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357619|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357620|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357621|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357622|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357623|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357624|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357625|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357626|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357627|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357628|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357629|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357630|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357631|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357632|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357633|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357634|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357635|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357636|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357637|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357638|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357639|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357640|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357641|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357642|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357643|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357644|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357645|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357646|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357647|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357648|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357649|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357650|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357651|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357652|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357653|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357654|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357655|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357656|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357657|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357658|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357659|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357660|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357661|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357662|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357663|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357664|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357665|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357666|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357667|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357668|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357669|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357670|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357671|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357672|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357673|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357674|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357675|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357676|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357677|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357678|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357679|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357680|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357681|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357682|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357683|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357684|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357685|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357686|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357687|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357688|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357689|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357690|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357691|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357692|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357693|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357694|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357695|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357696|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357697|NCT00735709|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357698|NCT00735709|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357699|NCT00735709|E2|Reported Event|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
357700|NCT00735709|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
357728|NCT00735644|B2|Baseline|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
358104|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
357701|NCT00735696|B1|Baseline|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks."
357702|NCT00735696|P1|Participant Flow|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357703|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357704|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357705|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357706|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357707|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357708|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357709|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357729|NCT00735644|B1|Baseline|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
357730|NCT00735644|P5|Participant Flow|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis A vaccine
357731|NCT00735644|P4|Participant Flow|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357710|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357711|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357712|NCT00735696|E1|Reported Event|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
357713|NCT00735670|B3|Baseline|Total|Total of all reporting groups
357714|NCT00735670|B2|Baseline|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
357715|NCT00735670|B1|Baseline|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
357716|NCT00735670|P2|Participant Flow|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
357717|NCT00735670|P1|Participant Flow|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
357718|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
357719|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
357720|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
357721|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
357722|NCT00735670|E2|Reported Event|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
357723|NCT00735670|E1|Reported Event|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
357724|NCT00735644|B6|Baseline|Total|Total of all reporting groups
357725|NCT00735644|B5|Baseline|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357726|NCT00735644|B4|Baseline|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357727|NCT00735644|B3|Baseline|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357822|NCT00735449|B3|Baseline|Total|Total of all reporting groups
357732|NCT00735644|P3|Participant Flow|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
357733|NCT00735644|P2|Participant Flow|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357734|NCT00735644|P1|Participant Flow|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
357735|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357736|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357737|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357738|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357739|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
357740|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357741|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357742|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357743|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357744|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
357745|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
357746|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
357747|NCT00735644|O3|Outcome|JE-CV MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
357748|NCT00735644|O2|Outcome|JE-CV MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
357749|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
357750|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357751|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357752|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357753|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357754|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
357755|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357756|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357757|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357758|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357759|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
357760|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357761|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357762|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357763|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357764|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
357765|NCT00735644|E5|Reported Event|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
357766|NCT00735644|E4|Reported Event|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
357767|NCT00735644|E3|Reported Event|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
357768|NCT00735644|E2|Reported Event|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
357769|NCT00735644|E1|Reported Event|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
357770|NCT00735618|B1|Baseline|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
357771|NCT00735618|P1|Participant Flow|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
357772|NCT00735618|O1|Outcome|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
357927|NCT00734994|E1|Reported Event|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
357773|NCT00735618|E1|Reported Event|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
357774|NCT00735553|B4|Baseline|Total|Total of all reporting groups
357775|NCT00735553|B3|Baseline|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
357776|NCT00735553|B2|Baseline|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
357777|NCT00735553|B1|Baseline|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
357778|NCT00735553|P1|Participant Flow|All Groups|25 mg, 50 mg oral daily dose of Proellex or placebo
357779|NCT00735553|O3|Outcome|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
357780|NCT00735553|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
357781|NCT00735553|O1|Outcome|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
357782|NCT00735553|E3|Reported Event|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
357783|NCT00735553|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
357784|NCT00735553|E1|Reported Event|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
357785|NCT00735475|B3|Baseline|Total|Total of all reporting groups
357786|NCT00735475|B2|Baseline|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357787|NCT00735475|B1|Baseline|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357788|NCT00735475|P2|Participant Flow|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357789|NCT00735475|P1|Participant Flow|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357790|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357791|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357792|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357793|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357794|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357795|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357796|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357797|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357798|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357799|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357800|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357801|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357802|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357803|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357804|NCT00735475|E2|Reported Event|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
357805|NCT00735475|E1|Reported Event|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
357806|NCT00735462|B4|Baseline|Total|Total of all reporting groups
357807|NCT00735462|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
357808|NCT00735462|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357809|NCT00735462|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357810|NCT00735462|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
357811|NCT00735462|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357812|NCT00735462|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357813|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
357814|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357815|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357816|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
357817|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357818|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357819|NCT00735462|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
357820|NCT00735462|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357821|NCT00735462|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
357823|NCT00735449|B2|Baseline|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357824|NCT00735449|B1|Baseline|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357825|NCT00735449|P2|Participant Flow|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357826|NCT00735449|P1|Participant Flow|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357827|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357828|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357829|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357830|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357831|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357832|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357833|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357834|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357835|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357836|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357837|NCT00735449|E2|Reported Event|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
357838|NCT00735449|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
357839|NCT00735436|B1|Baseline|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357840|NCT00735436|P1|Participant Flow|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
357841|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357842|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357843|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
357844|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
357845|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357846|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357847|NCT00735436|E1|Reported Event|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
357848|NCT00735397|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357849|NCT00735397|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357850|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357851|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357852|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357853|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357854|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357855|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357928|NCT00734968|B3|Baseline|Total|Total of all reporting groups
357856|NCT00735397|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357857|NCT00735397|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
357858|NCT00735371|B5|Baseline|Total|Total of all reporting groups
357859|NCT00735371|B4|Baseline|Placebo|Placebo
357860|NCT00735371|B3|Baseline|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357861|NCT00735371|B2|Baseline|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357862|NCT00735371|B1|Baseline|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357863|NCT00735371|P4|Participant Flow|Placebo|Placebo
357864|NCT00735371|P3|Participant Flow|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357865|NCT00735371|P2|Participant Flow|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357866|NCT00735371|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357867|NCT00735371|O4|Outcome|Placebo|Placebo
357868|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357869|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357870|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357871|NCT00735371|O4|Outcome|Placebo|Placebo
357872|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357873|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357874|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357875|NCT00735371|O4|Outcome|Placebo|Placebo
357876|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357877|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357878|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357879|NCT00735371|E4|Reported Event|Placebo|Placebo
357880|NCT00735371|E3|Reported Event|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357881|NCT00735371|E2|Reported Event|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357882|NCT00735371|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
357883|NCT00735306|B1|Baseline|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
357884|NCT00735306|P1|Participant Flow|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
357885|NCT00735306|O1|Outcome|Single Arm Avastin, Tarceva and Radiation Therapy|"Avastin, Tarceva and Radiation Therapy~Avastin: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy~Tarceva: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy~Radiation Therapy: Radiation to the pancreas Monday through Friday for 28 treatments"
357886|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
357887|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
357888|NCT00735306|E1|Reported Event|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
357889|NCT00735072|B3|Baseline|Total|Total of all reporting groups
357890|NCT00735072|B2|Baseline|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357891|NCT00735072|B1|Baseline|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357892|NCT00735072|P2|Participant Flow|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357893|NCT00735072|P1|Participant Flow|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357894|NCT00735072|O2|Outcome|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357895|NCT00735072|O1|Outcome|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357896|NCT00735072|E2|Reported Event|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357897|NCT00735072|E1|Reported Event|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
357898|NCT00735007|B1|Baseline|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357899|NCT00735007|P1|Participant Flow|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357900|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357901|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357902|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357903|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357904|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357905|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357906|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357907|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357908|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357909|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357910|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357911|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357912|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357913|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357914|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357915|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357916|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357917|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357918|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357919|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357920|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357921|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357922|NCT00735007|E1|Reported Event|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
357923|NCT00734994|B1|Baseline|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
357924|NCT00734994|P1|Participant Flow|Mitomycin C With Hyperthermia and Recurrent Bladder Cancer|Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
357925|NCT00734994|O1|Outcome|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
357926|NCT00734994|O1|Outcome|Hyperthermia System, Mitomycin C|"Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.~Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence~Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder"
357929|NCT00734968|B2|Baseline|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
357930|NCT00734968|B1|Baseline|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357931|NCT00734968|P2|Participant Flow|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357932|NCT00734968|P1|Participant Flow|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets."
357933|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
357934|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357935|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
357936|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357937|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
357938|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357939|NCT00734968|E2|Reported Event|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
357940|NCT00734968|E1|Reported Event|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
357941|NCT00734929|B3|Baseline|Total|Total of all reporting groups
357942|NCT00734929|B2|Baseline|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357943|NCT00734929|B1|Baseline|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357944|NCT00734929|P2|Participant Flow|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357945|NCT00734929|P1|Participant Flow|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357946|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357947|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357948|NCT00734929|O2|Outcome|Ondansetron + Dexamethasone|"Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia~Ondansetron + Dexamethasone: Ondansetron 4 mg + Dexamethasone 10 mg"
357949|NCT00734929|O1|Outcome|Aprepitant + Dexamethasone|"Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia~Aprepitant + Dexamethasone: Aprepitant 40 mg + Dexamethasone 10 mg"
357950|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357951|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357952|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357953|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357954|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357955|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357956|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357957|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357958|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357959|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357960|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357961|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357962|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357963|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357964|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357965|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357966|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357967|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357968|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357969|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357970|NCT00734929|E2|Reported Event|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
357971|NCT00734929|E1|Reported Event|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
357972|NCT00734851|B1|Baseline|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357973|NCT00734851|P1|Participant Flow|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357974|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357975|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357976|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357977|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357978|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357979|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357980|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357981|NCT00734851|E1|Reported Event|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
357982|NCT00734799|B3|Baseline|Total|Total of all reporting groups
357983|NCT00734799|B2|Baseline|Intervention|Sleep Intervention for PTSD (SIP)
357984|NCT00734799|B1|Baseline|Wait List|Usual Care/Wait-List Control
357985|NCT00734799|P2|Participant Flow|Intervention|Sleep Intervention for PTSD (SIP)
357986|NCT00734799|P1|Participant Flow|Wait List|Usual Care/Wait-List Control
357987|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
357988|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
357989|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
357990|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
357991|NCT00734799|E2|Reported Event|Intervention|Sleep Intervention for PTSD (SIP)
357992|NCT00734799|E1|Reported Event|Wait List|Usual Care/Wait-List Control
357993|NCT00734747|B1|Baseline|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357994|NCT00734747|P1|Participant Flow|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~Medigus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357995|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357996|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357997|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357998|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
357999|NCT00734747|E1|Reported Event|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
358000|NCT00734734|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358045|NCT00734617|B1|Baseline|Less Dependent|
358046|NCT00734617|P2|Participant Flow|More Dependent|
358047|NCT00734617|P1|Participant Flow|Less Dependent|
358001|NCT00734734|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358002|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
358003|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358004|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358005|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358006|NCT00734734|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
358007|NCT00734656|B1|Baseline|All Study Participants|All study participants enrolled in Lab Session 1
358008|NCT00734656|P4|Participant Flow|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358009|NCT00734656|P3|Participant Flow|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358010|NCT00734656|P2|Participant Flow|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358011|NCT00734656|P1|Participant Flow|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358012|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358013|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358014|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358015|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358016|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358017|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358018|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358019|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358020|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358021|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358022|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358023|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358024|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358025|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358026|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358027|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358028|NCT00734656|E4|Reported Event|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
358029|NCT00734656|E3|Reported Event|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
358030|NCT00734656|E2|Reported Event|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
358031|NCT00734656|E1|Reported Event|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
358032|NCT00734630|B3|Baseline|Total|Total of all reporting groups
358033|NCT00734630|B2|Baseline|Placebo|Matching placebo tablets, oral administration
358034|NCT00734630|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
358035|NCT00734630|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
358036|NCT00734630|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
358037|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
358038|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
358039|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
358040|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
358041|NCT00734630|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
358042|NCT00734630|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
358043|NCT00734617|B3|Baseline|Total|Total of all reporting groups
358044|NCT00734617|B2|Baseline|More Dependent|
358053|NCT00734604|B6|Baseline|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
358054|NCT00734604|B5|Baseline|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
358055|NCT00734604|B4|Baseline|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
358056|NCT00734604|B3|Baseline|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
358057|NCT00734604|B2|Baseline|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
358058|NCT00734604|B1|Baseline|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
358059|NCT00734604|P6|Participant Flow|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
358060|NCT00734604|P5|Participant Flow|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
358061|NCT00734604|P4|Participant Flow|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
358062|NCT00734604|P3|Participant Flow|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
358063|NCT00734604|P2|Participant Flow|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
358064|NCT00734604|P1|Participant Flow|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
358065|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358066|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358067|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358068|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358069|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358070|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358071|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358072|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358073|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358074|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358075|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358076|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358077|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358078|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358079|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358080|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358081|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358082|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358083|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358084|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358085|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358086|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358087|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358088|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358089|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358090|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358091|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358092|NCT00734604|O3|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358093|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|tadalafil 20 mg as needed [T(PRN)]
358094|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358095|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358096|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358097|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358098|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358099|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358100|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358101|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358102|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358105|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358106|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358107|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358108|NCT00734604|E3|Reported Event|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
358109|NCT00734604|E2|Reported Event|Sildenafil Citrate as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
358110|NCT00734604|E1|Reported Event|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
358111|NCT00734591|B3|Baseline|Total|Total of all reporting groups
358112|NCT00734591|B2|Baseline|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358113|NCT00734591|B1|Baseline|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358114|NCT00734591|P2|Participant Flow|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358115|NCT00734591|P1|Participant Flow|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358116|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358117|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358118|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358119|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358120|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358121|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358122|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358123|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358124|NCT00734591|E2|Reported Event|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358125|NCT00734591|E1|Reported Event|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
358126|NCT00734578|B4|Baseline|Total|Total of all reporting groups
358127|NCT00734578|B3|Baseline|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358128|NCT00734578|B2|Baseline|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358168|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses"
359289|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359290|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
358129|NCT00734578|B1|Baseline|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358130|NCT00734578|P3|Participant Flow|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358131|NCT00734578|P2|Participant Flow|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358132|NCT00734578|P1|Participant Flow|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358133|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358134|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358135|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358136|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358137|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358138|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358139|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358140|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358141|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358142|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358143|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358144|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358145|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358146|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358169|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
359291|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
358147|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358148|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358149|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358150|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358151|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358152|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358153|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358154|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358155|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358156|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358157|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358158|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358159|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358160|NCT00734578|E3|Reported Event|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
358161|NCT00734578|E2|Reported Event|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358162|NCT00734578|E1|Reported Event|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
358163|NCT00734539|B3|Baseline|Total|Total of all reporting groups
358164|NCT00734539|B2|Baseline|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358165|NCT00734539|B1|Baseline|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358166|NCT00734539|P2|Participant Flow|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358167|NCT00734539|P1|Participant Flow|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358170|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly for a total of up to 12-13 doses"
358171|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
358172|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358173|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358174|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358175|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358176|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358177|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358178|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358179|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358180|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358181|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358182|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358183|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358184|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358185|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358186|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358187|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358188|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358189|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358190|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358191|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358192|NCT00734539|E2|Reported Event|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
358193|NCT00734539|E1|Reported Event|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
358194|NCT00734500|B1|Baseline|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
358195|NCT00734500|P1|Participant Flow|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
358196|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
358197|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
358198|NCT00734500|E1|Reported Event|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
358199|NCT00734474|B10|Baseline|Total|Total of all reporting groups
358200|NCT00734474|B9|Baseline|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358201|NCT00734474|B8|Baseline|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358202|NCT00734474|B7|Baseline|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358203|NCT00734474|B6|Baseline|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
359292|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
358204|NCT00734474|B5|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358205|NCT00734474|B4|Baseline|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358206|NCT00734474|B3|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358207|NCT00734474|B2|Baseline|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358208|NCT00734474|B1|Baseline|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358209|NCT00734474|P9|Participant Flow|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358210|NCT00734474|P8|Participant Flow|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358211|NCT00734474|P7|Participant Flow|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358212|NCT00734474|P6|Participant Flow|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358213|NCT00734474|P5|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358214|NCT00734474|P4|Participant Flow|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358215|NCT00734474|P3|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358216|NCT00734474|P2|Participant Flow|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358217|NCT00734474|P1|Participant Flow|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358218|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358219|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358220|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358221|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358241|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
359293|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
358222|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358223|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358224|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358225|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358226|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358227|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358228|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358229|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358230|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358231|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358232|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358233|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358234|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358235|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358236|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358237|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358238|NCT00734474|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.~Placebo: tablet, administered orally, once daily for up to 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"
358239|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358240|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358400|NCT00734344|P1|Participant Flow|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
358242|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358243|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358244|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358245|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358246|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358247|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358248|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358249|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358250|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358251|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358252|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358253|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358254|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358255|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358256|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358257|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358258|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358259|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358260|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358261|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358262|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358263|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358264|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358265|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358266|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358267|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358268|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358269|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358270|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358271|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358272|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358273|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358274|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358275|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358276|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358277|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358278|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358279|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358280|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358281|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358282|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358283|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358284|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358285|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358286|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358287|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358288|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358289|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358290|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358291|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358292|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358293|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358294|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358295|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358296|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358297|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358298|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358299|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358300|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358301|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358302|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358303|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358304|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358305|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358401|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358306|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358307|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358308|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358309|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358310|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358311|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358312|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358313|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358314|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358315|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358316|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358317|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358318|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358319|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358320|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358321|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358322|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358323|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358324|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358325|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358326|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358327|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358328|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358329|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358330|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358331|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358332|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358333|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358334|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358335|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358336|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358337|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358338|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358339|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358340|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358341|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358342|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358343|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358344|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358345|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358346|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358347|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358348|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358349|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358350|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358351|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358352|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358353|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358354|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358355|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358356|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358357|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358358|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358359|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358360|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358361|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358362|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358363|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358364|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358365|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358366|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358367|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358368|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358369|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358370|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358371|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358372|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358373|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358374|NCT00734474|E9|Reported Event|Placebo/Sitagliptin (Baseline Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358375|NCT00734474|E8|Reported Event|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358376|NCT00734474|E7|Reported Event|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358377|NCT00734474|E6|Reported Event|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
358378|NCT00734474|E5|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks"
358379|NCT00734474|E4|Reported Event|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
358380|NCT00734474|E3|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
358381|NCT00734474|E2|Reported Event|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
358382|NCT00734474|E1|Reported Event|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
358383|NCT00734409|B3|Baseline|Total|Total of all reporting groups
358384|NCT00734409|B2|Baseline|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358385|NCT00734409|B1|Baseline|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358386|NCT00734409|P2|Participant Flow|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358387|NCT00734409|P1|Participant Flow|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358388|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358389|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358390|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358391|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358392|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358393|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358394|NCT00734409|E2|Reported Event|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
358395|NCT00734409|E1|Reported Event|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
358396|NCT00734344|B3|Baseline|Total|Total of all reporting groups
358397|NCT00734344|B2|Baseline|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
358398|NCT00734344|B1|Baseline|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
358399|NCT00734344|P2|Participant Flow|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
358764|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358402|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358403|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358404|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358405|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358406|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358407|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358408|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358409|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358410|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358411|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358412|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358413|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358414|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358415|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358416|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358417|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358418|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358419|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358420|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358421|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358422|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358423|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358424|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358425|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358426|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358427|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358428|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358429|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358430|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358431|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358432|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358433|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358434|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358435|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358436|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358437|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
359294|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
358438|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358439|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358440|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358441|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358442|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358443|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358444|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358445|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358446|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358447|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358448|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358449|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358450|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358451|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358452|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358453|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358454|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358455|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358456|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358457|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358458|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358459|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358460|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358461|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358462|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358463|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
358464|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
358465|NCT00734344|E2|Reported Event|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
358466|NCT00734344|E1|Reported Event|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
358467|NCT00734305|B3|Baseline|Total|Total of all reporting groups
358468|NCT00734305|B2|Baseline|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
358469|NCT00734305|B1|Baseline|MM-121 Dose Escalation|MM-121: Dose escalation Frequency - once weekly IV
358470|NCT00734305|P7|Participant Flow|Expansion Cohort|(Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
358471|NCT00734305|P6|Participant Flow|Dose Escalation: Cohort 6|MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
358472|NCT00734305|P5|Participant Flow|Dose Escalation: Cohort 5|MM-121: 20 mg/kg IV QW
358473|NCT00734305|P4|Participant Flow|Dose Escalation: Cohort 4|MM-121: 15 mg/kg IV QW
358474|NCT00734305|P3|Participant Flow|Dose Escalation: Cohort 3|MM-121: 10 mg/kg IV QW
358475|NCT00734305|P2|Participant Flow|Dose Escalation: Cohort 2|MM-121: 6 mg/kg IV QW
358476|NCT00734305|P1|Participant Flow|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
358765|NCT00734097|E1|Reported Event|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358766|NCT00734071|B3|Baseline|Total|Total of all reporting groups
358477|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
358478|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
358479|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
358480|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
358481|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
358482|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
358483|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
358484|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
358485|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
358486|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
358487|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
358488|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
358489|NCT00734305|O6|Outcome|Cohort 6|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses
358490|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
358491|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
358492|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
358493|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
358494|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
358495|NCT00734305|O1|Outcome|Dose Escalation: All Participants|MM-121: Dose escalation Frequency - once weekly
358496|NCT00734305|O7|Outcome|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
358497|NCT00734305|O6|Outcome|Dose Escalation: Cohort 6|MM-121 40 mg/kg IV loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV weekly maintenance doses
358498|NCT00734305|O5|Outcome|Dose Escalation: Cohort 5|MM-121 20 mg/kg IV QW
358499|NCT00734305|O4|Outcome|Dose Escalation: Cohort 4|MM-121 15 mg/kg IV QW
358500|NCT00734305|O3|Outcome|Dose Escalation: Cohort 3|MM-121 10 mg/kg IV QW
358501|NCT00734305|O2|Outcome|Dose Escalation: Cohort 2|MM-121 6 mg/kg IV QW
358502|NCT00734305|O1|Outcome|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
358503|NCT00734305|E1|Reported Event|All Participatants|Dose Escalation cohort participants + Expansion cohort participants
358504|NCT00734214|B3|Baseline|Total|Total of all reporting groups
358505|NCT00734214|B2|Baseline|0.45% NaCl|
358506|NCT00734214|B1|Baseline|0.9% NaCl|
358507|NCT00734214|P2|Participant Flow|0.45% NaCl|
358508|NCT00734214|P1|Participant Flow|0.9% NaCl|
358509|NCT00734214|O2|Outcome|0.45% NaCl|
358510|NCT00734214|O1|Outcome|0.9% NaCl|
358511|NCT00734214|E2|Reported Event|0.45% NaCl|
358512|NCT00734214|E1|Reported Event|0.9% NaCl|
358513|NCT00734162|B5|Baseline|Total|Total of all reporting groups
358514|NCT00734162|B4|Baseline|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358515|NCT00734162|B3|Baseline|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358516|NCT00734162|B2|Baseline|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358517|NCT00734162|B1|Baseline|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358518|NCT00734162|P4|Participant Flow|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358519|NCT00734162|P3|Participant Flow|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358520|NCT00734162|P2|Participant Flow|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358521|NCT00734162|P1|Participant Flow|TDF 12-14 Years|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358522|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358523|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358524|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358525|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358526|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358527|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358528|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358529|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358530|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358531|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358532|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358533|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358534|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358535|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358536|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358537|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358538|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358539|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358540|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358541|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358542|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358543|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358544|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358545|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358546|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358547|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358548|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358549|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358550|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358551|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358552|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358553|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358554|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358555|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358556|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358557|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358558|NCT00734162|O2|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358559|NCT00734162|O1|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358560|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358561|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358562|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358563|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358564|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358565|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358566|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358567|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358568|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358569|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358570|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358571|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358572|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358573|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358574|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358575|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358576|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358577|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358578|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358579|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358580|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358581|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358582|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358583|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358584|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358585|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358586|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358587|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358588|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358589|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358590|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358591|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358592|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358593|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358594|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358595|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358596|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358597|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358598|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358599|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358600|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358601|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358602|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358603|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358604|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358605|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358606|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358607|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358608|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358609|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358610|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358611|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358612|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358613|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358614|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358615|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358616|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358617|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358618|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358619|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358620|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358621|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358622|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358623|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358624|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358625|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358626|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358627|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358628|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358629|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358630|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358631|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358632|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358633|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358634|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358635|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358636|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358637|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358638|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358639|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358640|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358641|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358642|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358643|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358644|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358645|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358646|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358647|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358648|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358649|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358650|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358651|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358652|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358653|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358654|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358655|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358656|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358657|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358658|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358659|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358660|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358661|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358662|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358663|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358664|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358665|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358666|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358667|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358668|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358669|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358670|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358671|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358672|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358673|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358674|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358675|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358676|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358677|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358678|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358679|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358680|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358681|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358682|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358683|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358684|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358685|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358686|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358687|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358688|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358689|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358690|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358691|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358692|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358693|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358694|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358695|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358696|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358697|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358698|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358699|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358700|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358701|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358702|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358703|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358704|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358705|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358706|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358707|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358708|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358709|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358710|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358711|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358712|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358713|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358714|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358715|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358716|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358717|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358718|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358719|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358720|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358721|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358722|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358723|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358724|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358725|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358726|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358727|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358728|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358729|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358730|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358731|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358732|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358733|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358734|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358735|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358736|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358737|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358738|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358739|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
358740|NCT00734162|E4|Reported Event|Open-Label Placebo-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
358741|NCT00734162|E3|Reported Event|Open-Label TDF-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
358742|NCT00734162|E2|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
358743|NCT00734162|E1|Reported Event|Double-Blind TDF|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
358744|NCT00734149|B1|Baseline|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
358745|NCT00734149|P1|Participant Flow|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
358746|NCT00734149|O2|Outcome|Bortezomib+Melphalan+Prednisone: ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
358747|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone: Non-ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
358748|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
358749|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
358750|NCT00734149|E1|Reported Event|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
358751|NCT00734097|B1|Baseline|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358752|NCT00734097|P1|Participant Flow|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358753|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358754|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358755|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358756|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358757|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358758|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358759|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358760|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358761|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358762|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
358763|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
359295|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
358767|NCT00734071|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358768|NCT00734071|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358769|NCT00734071|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358770|NCT00734071|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358771|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358772|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358773|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358774|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358775|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358776|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358777|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358778|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358779|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358780|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358781|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358782|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358783|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358784|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358785|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358786|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358787|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358788|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358789|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358790|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358791|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358792|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358793|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358794|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358795|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358796|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358797|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358798|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358799|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358800|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358801|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358802|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358803|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358804|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358805|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358806|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358807|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358808|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358809|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358810|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358811|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358812|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358813|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358814|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358815|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358816|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358817|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358818|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358819|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358820|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358821|NCT00734071|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
358822|NCT00734071|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
358823|NCT00733954|B3|Baseline|Total|Total of all reporting groups
358824|NCT00733954|B2|Baseline|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358825|NCT00733954|B1|Baseline|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358826|NCT00733954|P2|Participant Flow|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358827|NCT00733954|P1|Participant Flow|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358828|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358829|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358830|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358831|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358832|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358833|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358834|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358835|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358836|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358837|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358838|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358839|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358840|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358841|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358842|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358843|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358844|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358845|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358846|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358847|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358848|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358849|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358850|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358851|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358852|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358853|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358854|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358855|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358856|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358857|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358858|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358859|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358860|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358861|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358862|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358863|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358864|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358865|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358866|NCT00733954|E2|Reported Event|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
358867|NCT00733954|E1|Reported Event|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
358868|NCT00733824|B6|Baseline|Total|Total of all reporting groups
358869|NCT00733824|B5|Baseline|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358870|NCT00733824|B4|Baseline|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358871|NCT00733824|B3|Baseline|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358872|NCT00733824|B2|Baseline|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358873|NCT00733824|B1|Baseline|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358874|NCT00733824|P5|Participant Flow|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358961|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358875|NCT00733824|P4|Participant Flow|Phase I - Cohort 4|240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
358876|NCT00733824|P3|Participant Flow|Phase I - Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358877|NCT00733824|P2|Participant Flow|Phase I - Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358878|NCT00733824|P1|Participant Flow|Phase I - Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358879|NCT00733824|O5|Outcome|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)~AMD3100~G-CSF~Apheresis"
358880|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358881|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358882|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358883|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358884|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
358885|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
358886|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358887|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358888|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358889|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358890|NCT00733824|O1|Outcome|Phase 1 (Dose Levels 1-4)|
358891|NCT00733824|E5|Reported Event|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358892|NCT00733824|E4|Reported Event|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358893|NCT00733824|E3|Reported Event|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358894|NCT00733824|E2|Reported Event|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358895|NCT00733824|E1|Reported Event|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
358896|NCT00733512|B1|Baseline|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
358897|NCT00733512|P1|Participant Flow|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
358898|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
358899|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
358900|NCT00733512|E1|Reported Event|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
358901|NCT00733499|B3|Baseline|Total|Total of all reporting groups
358902|NCT00733499|B2|Baseline|LCS Complete Porocoat|"102 patients~LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces"
358903|NCT00733499|B1|Baseline|LCS Complete Duofix|"102 patients~LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces"
358904|NCT00733499|P2|Participant Flow|LCS Complete Porocoat|"103 patients~LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces"
358905|NCT00733499|P1|Participant Flow|LCS Complete Duofix|"102 patients~LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces"
358906|NCT00733499|O2|Outcome|LCS Complete Porocoat|"102 patients~LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces"
358907|NCT00733499|O1|Outcome|LCS Complete Duofix|"102 patients~LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces"
358908|NCT00733499|E2|Reported Event|LCS Complete Porocoat|"103 patients~LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces"
359232|NCT00732992|B3|Baseline|Total|Total of all reporting groups
358909|NCT00733499|E1|Reported Event|LCS Complete Duofix|"102 patients~LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces"
358910|NCT00733421|B3|Baseline|Total|Total of all reporting groups
358911|NCT00733421|B2|Baseline|Control Tramadol|Tramadol 100 mg slow release twice daily
358912|NCT00733421|B1|Baseline|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358913|NCT00733421|P2|Participant Flow|Control Tramadol|Tramadol 100 mg slow release twice daily
358914|NCT00733421|P1|Participant Flow|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358915|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358916|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358917|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358918|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358919|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358920|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358921|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358922|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358923|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358924|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358925|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358926|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358927|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358928|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358929|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358930|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358931|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
358932|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358933|NCT00733421|E2|Reported Event|Control Tramadol|Tramadol 100 mg slow release twice daily
358934|NCT00733421|E1|Reported Event|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
358935|NCT00733369|B3|Baseline|Total|Total of all reporting groups
358936|NCT00733369|B2|Baseline|PFC Sigma RP|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing"
358937|NCT00733369|B1|Baseline|PFC Sigma RP-F|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing"
358938|NCT00733369|P2|Participant Flow|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358939|NCT00733369|P1|Participant Flow|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358940|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358941|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358942|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358943|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358944|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358945|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358946|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358947|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358948|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358949|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358950|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358951|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358952|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358953|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358954|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358955|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358956|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358957|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358958|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358959|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358960|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358962|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358963|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358964|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358965|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358966|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358967|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358968|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358969|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358970|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358971|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358972|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358973|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358974|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358975|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358976|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358977|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358978|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358979|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358980|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358981|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358982|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358983|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358984|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358985|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358986|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358987|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358988|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358989|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358990|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358991|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358992|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358993|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358994|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358995|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358996|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358997|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
358998|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
358999|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359000|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359001|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359002|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359003|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359004|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359005|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359006|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359007|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359008|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359009|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359010|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359011|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359012|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359013|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359014|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359015|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359016|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359017|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359018|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359019|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359020|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359021|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359022|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359023|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359024|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359025|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359026|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359027|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359028|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359029|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359030|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359031|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359032|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359033|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359034|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359035|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359036|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359037|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359038|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359039|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359040|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359041|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359042|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359043|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359044|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359045|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359046|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359047|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359048|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359049|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359050|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359051|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359052|NCT00733369|E2|Reported Event|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
359053|NCT00733369|E1|Reported Event|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
359054|NCT00733330|B3|Baseline|Total|Total of all reporting groups
359055|NCT00733330|B2|Baseline|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359056|NCT00733330|B1|Baseline|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359057|NCT00733330|P2|Participant Flow|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359058|NCT00733330|P1|Participant Flow|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359059|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359060|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359061|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359062|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359063|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359064|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359065|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359066|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359067|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359068|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359069|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359070|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359071|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359072|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359073|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359074|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359075|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359076|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359077|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359078|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359079|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359080|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359081|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359082|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359083|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359084|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359085|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359086|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359087|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359088|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359089|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359090|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359091|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359092|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359093|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359094|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359095|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359096|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359097|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359098|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359099|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359100|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359101|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359102|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359103|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359104|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359105|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359106|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359107|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359108|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359109|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359110|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359111|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359112|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359113|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359114|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359115|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359116|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359117|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359118|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359119|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359120|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359121|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359122|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359123|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359124|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359125|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359126|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359127|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359128|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359129|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359130|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359131|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359132|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359133|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359134|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359135|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359136|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
359137|NCT00733330|E2|Reported Event|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
359138|NCT00733330|E1|Reported Event|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
359139|NCT00733291|B3|Baseline|Total|Total of all reporting groups
359140|NCT00733291|B2|Baseline|Etafilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
359141|NCT00733291|B1|Baseline|Nelfilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
359142|NCT00733291|P4|Participant Flow|Etafilcon A no Soak / Etafilcon Soak|Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
359143|NCT00733291|P3|Participant Flow|Etafilcon A Soak / Etafilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
359144|NCT00733291|P2|Participant Flow|Nelfilcon A no Soak / Nelfilcon A Soak|Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
359145|NCT00733291|P1|Participant Flow|Nelfilcon A Soak / Nelfilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
359146|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
359147|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359148|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
359149|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359150|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
359151|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359152|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
359153|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359154|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
359155|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359156|NCT00733291|O2|Outcome|Nelfilcon A / No Soak|Nelfilcon A contact lenses inserted directly out of the blister package
359157|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359158|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
359159|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359160|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
359161|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359162|NCT00733291|E4|Reported Event|Etafilcon / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
359163|NCT00733291|E3|Reported Event|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359164|NCT00733291|E2|Reported Event|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
359165|NCT00733291|E1|Reported Event|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
359166|NCT00733278|B1|Baseline|IUD Placement|
359167|NCT00733278|P1|Participant Flow|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
359168|NCT00733278|O1|Outcome|IUD Strings|Visibility of IUD strings within the vagina at all times.
359169|NCT00733278|O1|Outcome|IUD Placement|IUD placement following removal of placenta at time of elective C-section
359170|NCT00733278|E1|Reported Event|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
359171|NCT00733226|B3|Baseline|Total|Total of all reporting groups
359172|NCT00733226|B2|Baseline|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359173|NCT00733226|B1|Baseline|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359174|NCT00733226|P2|Participant Flow|Placebo Group|The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359175|NCT00733226|P1|Participant Flow|Broncho-Vaxom Group|The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359176|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359177|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359178|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359179|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359180|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359181|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359182|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359183|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359184|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359185|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359186|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359187|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359188|NCT00733226|E2|Reported Event|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
359189|NCT00733226|E1|Reported Event|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
359190|NCT00733135|B1|Baseline|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
359191|NCT00733135|P1|Participant Flow|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
359192|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
359193|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
359194|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
359195|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.
359196|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
359197|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
359198|NCT00733135|E1|Reported Event|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
359199|NCT00733096|B4|Baseline|Total|Total of all reporting groups
359200|NCT00733096|B3|Baseline|Saline|Two epidural saline injections
359201|NCT00733096|B2|Baseline|Etanercept|Two epidural etanercept injections
359202|NCT00733096|B1|Baseline|Steroid|Two epidural steroid injections
359203|NCT00733096|P3|Participant Flow|Saline|Two epidural saline injections
359204|NCT00733096|P2|Participant Flow|Etanercept|Two epidural etanercept injections
359205|NCT00733096|P1|Participant Flow|Steroid|Two epidural steroid injections
359206|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
359207|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
359208|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
359209|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
359210|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
359211|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
359212|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
359213|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
359214|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
359215|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
359216|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
359217|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
359218|NCT00733096|E3|Reported Event|Saline|Two epidural saline injections
359219|NCT00733096|E2|Reported Event|Etanercept|Two epidural etanercept injections
359220|NCT00733096|E1|Reported Event|Steroid|Two epidural steroid injections
359221|NCT00733005|B3|Baseline|Total|Total of all reporting groups
359222|NCT00733005|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
359223|NCT00733005|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359224|NCT00733005|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
359225|NCT00733005|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359226|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
359227|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359228|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
359229|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359230|NCT00733005|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
359231|NCT00733005|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359233|NCT00732992|B2|Baseline|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359234|NCT00732992|B1|Baseline|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359235|NCT00732992|P2|Participant Flow|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359236|NCT00732992|P1|Participant Flow|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359237|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359238|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359239|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359240|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359241|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359242|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359243|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359244|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359245|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359246|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359247|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359248|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359249|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359250|NCT00732992|E2|Reported Event|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
359251|NCT00732992|E1|Reported Event|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
359252|NCT00732940|B3|Baseline|Total|Total of all reporting groups
359253|NCT00732940|B2|Baseline|Belimumab SC 3X/WK|
359254|NCT00732940|B1|Baseline|Belimumab SC Q2WKS|
359255|NCT00732940|P2|Participant Flow|Belimumab SC 3X/WK|200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
359256|NCT00732940|P1|Participant Flow|Belimumab SC Q2WKS|100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
359257|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359258|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359259|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359260|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359261|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359262|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359263|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359264|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359265|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359266|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359267|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359268|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359269|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359270|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359271|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359272|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359273|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359296|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359297|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359298|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359299|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359300|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359301|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359302|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359303|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359304|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359305|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359306|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359307|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359308|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359309|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359310|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359311|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359312|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359313|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359314|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359315|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359316|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359317|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359318|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359319|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
359320|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
359321|NCT00732940|E2|Reported Event|Belimumab SC 3X/WK|The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter.
359322|NCT00732940|E1|Reported Event|Belimumab SC Q2WKS|The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter.
359323|NCT00732875|B1|Baseline|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359324|NCT00732875|P1|Participant Flow|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359325|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359326|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359327|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359328|NCT00732875|E1|Reported Event|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
359329|NCT00732758|B3|Baseline|Total|Total of all reporting groups
359330|NCT00732758|B2|Baseline|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359331|NCT00732758|B1|Baseline|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359332|NCT00732758|P2|Participant Flow|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359333|NCT00732758|P1|Participant Flow|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359334|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359335|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359336|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359337|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359338|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359339|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359340|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359341|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359342|NCT00732758|E2|Reported Event|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
359343|NCT00732758|E1|Reported Event|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
359344|NCT00732680|B1|Baseline|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
359345|NCT00732680|P1|Participant Flow|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
359346|NCT00732680|O1|Outcome|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
359347|NCT00732680|E1|Reported Event|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
359348|NCT00732641|B3|Baseline|Total|Total of all reporting groups
359349|NCT00732641|B2|Baseline|No Treatment|Participants were observed and received no treatment
359350|NCT00732641|B1|Baseline|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359351|NCT00732641|P2|Participant Flow|No Treatment|Participants were observed and received no treatment
359352|NCT00732641|P1|Participant Flow|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359353|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359354|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359355|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359550|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359356|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359357|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359358|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359359|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359360|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359361|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359362|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359363|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359364|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359365|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
359366|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359367|NCT00732641|E2|Reported Event|No Treatment|Participants were observed and received no treatment
359368|NCT00732641|E1|Reported Event|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
359369|NCT00732615|B3|Baseline|Total|Total of all reporting groups
359370|NCT00732615|B2|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359371|NCT00732615|B1|Baseline|Placebo|Matching Placebo: Placebo for subcutaneous injection
359372|NCT00732615|P2|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359373|NCT00732615|P1|Participant Flow|Placebo|Matching Placebo: Placebo for subcutaneous injection
359374|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359375|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
359376|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359377|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
359378|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359379|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
359380|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
359381|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
359382|NCT00732615|E2|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
359383|NCT00732615|E1|Reported Event|Placebo|Matching Placebo: Placebo for subcutaneous injection
359384|NCT00732472|B5|Baseline|Total|Total of all reporting groups
359385|NCT00732472|B4|Baseline|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359386|NCT00732472|B3|Baseline|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359387|NCT00732472|B2|Baseline|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359388|NCT00732472|B1|Baseline|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359389|NCT00732472|P4|Participant Flow|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359390|NCT00732472|P3|Participant Flow|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359391|NCT00732472|P2|Participant Flow|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359392|NCT00732472|P1|Participant Flow|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359393|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359394|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359395|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359396|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359397|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359398|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359729|NCT00731666|E1|Reported Event|Titan® IPP|Subjects implanted with Titan® IPP
359399|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359400|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359401|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359402|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359403|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359404|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359405|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359406|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359407|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359408|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359409|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359410|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359411|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359412|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359413|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359414|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359415|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359416|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359417|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359418|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359419|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359420|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359421|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359422|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359423|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359424|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359425|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359426|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359427|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359428|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359429|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359430|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359836|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359431|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359432|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359433|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359434|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359435|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359436|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359437|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359438|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC19 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359439|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359440|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359441|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359442|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359443|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359444|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359445|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359446|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359447|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359448|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359449|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359450|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359451|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359452|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359453|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359454|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359455|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359456|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359457|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359458|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359459|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359460|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359461|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359462|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359837|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359463|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359464|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359465|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359466|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359467|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359468|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359469|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359470|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359471|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359472|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359473|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359474|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359475|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359476|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359477|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359478|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359479|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359480|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359481|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359482|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359483|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359484|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359485|NCT00732472|E4|Reported Event|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
359486|NCT00732472|E3|Reported Event|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
359487|NCT00732472|E2|Reported Event|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
359488|NCT00732472|E1|Reported Event|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
359489|NCT00732381|B3|Baseline|Total|Total of all reporting groups
359490|NCT00732381|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
359491|NCT00732381|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359492|NCT00732381|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
359493|NCT00732381|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359494|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
359495|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359496|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
359497|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359498|NCT00732381|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
359499|NCT00732381|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
359547|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359500|NCT00732303|B1|Baseline|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359501|NCT00732303|P1|Participant Flow|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359502|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359503|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359504|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359505|NCT00732303|E1|Reported Event|Pemetrexed\Radiation|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
359506|NCT00732238|B3|Baseline|Total|Total of all reporting groups
359507|NCT00732238|B2|Baseline|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
359508|NCT00732238|B1|Baseline|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
359509|NCT00732238|P2|Participant Flow|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
359548|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359549|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359510|NCT00732238|P1|Participant Flow|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
359511|NCT00732238|O2|Outcome|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
359512|NCT00732238|O1|Outcome|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
359513|NCT00732238|O2|Outcome|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
359514|NCT00732238|O1|Outcome|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
359515|NCT00732238|E2|Reported Event|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
359516|NCT00732238|E1|Reported Event|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
359517|NCT00732225|B6|Baseline|Total|Total of all reporting groups
359518|NCT00732225|B5|Baseline|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359519|NCT00732225|B4|Baseline|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359520|NCT00732225|B3|Baseline|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359521|NCT00732225|B2|Baseline|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359522|NCT00732225|B1|Baseline|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359523|NCT00732225|P5|Participant Flow|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359524|NCT00732225|P4|Participant Flow|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359525|NCT00732225|P3|Participant Flow|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359526|NCT00732225|P2|Participant Flow|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359527|NCT00732225|P1|Participant Flow|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359528|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359529|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359530|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359531|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359532|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359533|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359534|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359535|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359536|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359537|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359538|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359539|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359540|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359541|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359542|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359543|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359544|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359545|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359546|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
361493|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
359551|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359552|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359553|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359554|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359555|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359556|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359557|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359558|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359559|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359560|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359561|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359562|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359563|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359564|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359565|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359566|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359567|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359568|NCT00732225|E5|Reported Event|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
359569|NCT00732225|E4|Reported Event|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
359570|NCT00732225|E3|Reported Event|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
359571|NCT00732225|E2|Reported Event|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
359572|NCT00732225|E1|Reported Event|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
359573|NCT00732069|B1|Baseline|All Study Participants|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359574|NCT00732069|P6|Participant Flow|Valsartan, Ramipril, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359575|NCT00732069|P5|Participant Flow|Ramipril, Valsartan, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359576|NCT00732069|P4|Participant Flow|Valsartan, Then Placebo, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359577|NCT00732069|P3|Participant Flow|Ramipril, Then Placebo, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359578|NCT00732069|P2|Participant Flow|Placebo, Valsartan, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359579|NCT00732069|P1|Participant Flow|Placebo, Then Ramipril, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
359580|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359581|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359582|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359583|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359584|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359585|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
359586|NCT00732069|E3|Reported Event|Placebo|All subjects receiving placebo
359587|NCT00732069|E2|Reported Event|Valsartan|All subjects receiving valsartan
359588|NCT00732069|E1|Reported Event|Ramipril|All subjects receiving ramipril
359589|NCT00732030|B1|Baseline|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359590|NCT00732030|P1|Participant Flow|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359591|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359592|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359593|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359594|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359595|NCT00732030|E1|Reported Event|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
359596|NCT00731939|B1|Baseline|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
361494|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
359597|NCT00731939|P1|Participant Flow|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359598|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359599|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359600|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359601|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359602|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359603|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359604|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359605|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359606|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359607|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359608|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359609|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359610|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359611|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359612|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359613|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359614|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359615|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359616|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359617|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359618|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359619|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359620|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359621|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359650|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359622|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359623|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359624|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359625|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359626|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359627|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359628|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359629|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359630|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359631|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359632|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359633|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359634|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359635|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359636|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359637|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359638|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359639|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359640|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359641|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359642|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359643|NCT00731939|E1|Reported Event|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
359644|NCT00731874|B3|Baseline|Total|Total of all reporting groups
359645|NCT00731874|B2|Baseline|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359646|NCT00731874|B1|Baseline|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359647|NCT00731874|P2|Participant Flow|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359648|NCT00731874|P1|Participant Flow|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359649|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359651|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359652|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359653|NCT00731874|E2|Reported Event|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359654|NCT00731874|E1|Reported Event|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
359655|NCT00731822|B3|Baseline|Total|Total of all reporting groups
359656|NCT00731822|B2|Baseline|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359657|NCT00731822|B1|Baseline|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359658|NCT00731822|P2|Participant Flow|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359659|NCT00731822|P1|Participant Flow|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359660|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359661|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359662|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359663|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359664|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359665|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359666|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359667|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359668|NCT00731822|E2|Reported Event|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
359669|NCT00731822|E1|Reported Event|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
359670|NCT00731783|B3|Baseline|Total|Total of all reporting groups
359671|NCT00731783|B2|Baseline|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359672|NCT00731783|B1|Baseline|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359673|NCT00731783|P2|Participant Flow|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
359674|NCT00731783|P1|Participant Flow|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
359675|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359676|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359677|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359678|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359679|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359680|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359681|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359682|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359683|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359684|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359685|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359686|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359687|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359688|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359689|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359690|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359691|NCT00731783|E2|Reported Event|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
359838|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359692|NCT00731783|E1|Reported Event|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
359693|NCT00731731|B4|Baseline|Total|Total of all reporting groups
359694|NCT00731731|B3|Baseline|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359695|NCT00731731|B2|Baseline|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359696|NCT00731731|B1|Baseline|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359697|NCT00731731|P3|Participant Flow|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359698|NCT00731731|P2|Participant Flow|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359699|NCT00731731|P1|Participant Flow|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359700|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
359701|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
359702|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
359723|NCT00731679|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359724|NCT00731666|B1|Baseline|Titan® IPP|Subjects implanted with Titan® IPP
359725|NCT00731666|P1|Participant Flow|Titan® IPP|Subjects implanted with Titan® IPP
359726|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
359727|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
359703|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
359704|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359705|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359706|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359707|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359708|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359709|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
359710|NCT00731731|E3|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
359711|NCT00731731|E2|Reported Event|Phase I, Dose Level 1|laboratory biomarker analysis: Correlative studies
359712|NCT00731731|E1|Reported Event|Phase I, Dose Level 0|laboratory biomarker analysis: Correlative studies
359713|NCT00731679|B3|Baseline|Total|Total of all reporting groups
359714|NCT00731679|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359715|NCT00731679|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359716|NCT00731679|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359717|NCT00731679|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359718|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359719|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359720|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359721|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359722|NCT00731679|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
359728|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
359730|NCT00731653|B1|Baseline|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
359731|NCT00731653|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
359732|NCT00731653|O1|Outcome|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
359733|NCT00731653|E1|Reported Event|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
359734|NCT00731640|B3|Baseline|Total|Total of all reporting groups
359735|NCT00731640|B2|Baseline|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359736|NCT00731640|B1|Baseline|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359737|NCT00731640|P2|Participant Flow|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359738|NCT00731640|P1|Participant Flow|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359739|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359740|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359741|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359742|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359743|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359744|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359745|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359746|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359747|NCT00731640|E2|Reported Event|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
359748|NCT00731640|E1|Reported Event|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
359749|NCT00731614|B3|Baseline|Total|Total of all reporting groups
359750|NCT00731614|B2|Baseline|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
359751|NCT00731614|B1|Baseline|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
359752|NCT00731614|P2|Participant Flow|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
359753|NCT00731614|P1|Participant Flow|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
359754|NCT00731614|O2|Outcome|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
359755|NCT00731614|O1|Outcome|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
359756|NCT00731614|E2|Reported Event|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
359757|NCT00731614|E1|Reported Event|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
359758|NCT00731549|B1|Baseline|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359759|NCT00731549|P1|Participant Flow|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359760|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359761|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359762|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359763|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359764|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359765|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359766|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359767|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359768|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359769|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359770|NCT00731549|E1|Reported Event|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
359771|NCT00731484|B1|Baseline|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
359772|NCT00731484|P1|Participant Flow|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
359773|NCT00731484|O1|Outcome|General Population|Subjects were recruited from patients presenting for a routine visit at the physician office study sites
359774|NCT00731484|E1|Reported Event|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
359775|NCT00731341|B1|Baseline|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359776|NCT00731341|P1|Participant Flow|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359777|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359778|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359779|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
361495|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
359780|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359781|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359782|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359783|NCT00731341|E1|Reported Event|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
359784|NCT00731211|B1|Baseline|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
359785|NCT00731211|P1|Participant Flow|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
359786|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
359787|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
359788|NCT00731211|E1|Reported Event|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
359789|NCT00731198|B3|Baseline|Total|Total of all reporting groups
359790|NCT00731198|B2|Baseline|Active Comparator|Hyoscine-N-butylbromide
359791|NCT00731198|B1|Baseline|Experimental|Drotaverine hydrochloride
359792|NCT00731198|P2|Participant Flow|Active Comparator|Hyoscine-N-butylbromide
359793|NCT00731198|P1|Participant Flow|Experimental|Drotaverine hydrochloride
359794|NCT00731198|O2|Outcome|Active Comparator|Hyoscine-N-butylbromide
359795|NCT00731198|O1|Outcome|Experimental|Drotaverine hydrochloride
359796|NCT00731198|E2|Reported Event|Active Comparator|Hyoscine-N-butylbromide
359797|NCT00731198|E1|Reported Event|Experimental|Drotaverine hydrochloride
359798|NCT00731133|B1|Baseline|Disulfiram|Disulfiram at 250 mg daily
359799|NCT00731133|P1|Participant Flow|Disulfiram|Disulfiram at 250 mg daily
359800|NCT00731133|O1|Outcome|Disulfiram 250 mg|
359801|NCT00731133|O1|Outcome|Disulfiram 250 mg|
359802|NCT00731133|E1|Reported Event|Disulfiram|Disulfiram at 250 mg daily
359803|NCT00731120|B4|Baseline|Total|Total of all reporting groups
359804|NCT00731120|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359805|NCT00731120|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359806|NCT00731120|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359807|NCT00731120|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359808|NCT00731120|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359809|NCT00731120|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359810|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359811|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359812|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359813|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359814|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359815|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359816|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359817|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359818|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359819|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359820|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359821|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359822|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359823|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359824|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359825|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359826|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359827|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359828|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359829|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359830|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359831|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359832|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359833|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359834|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359835|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359839|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359840|NCT00731120|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
359841|NCT00731120|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
359842|NCT00731120|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
359843|NCT00731094|B3|Baseline|Total|Total of all reporting groups
359844|NCT00731094|B2|Baseline|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359845|NCT00731094|B1|Baseline|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359846|NCT00731094|P2|Participant Flow|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359847|NCT00731094|P1|Participant Flow|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359848|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359849|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359850|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359851|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359852|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359853|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359854|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359855|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359856|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359857|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359858|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359859|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359860|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359956|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
359957|NCT00730912|E3|Reported Event|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
359861|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359862|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359863|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359864|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359865|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359866|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359867|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359868|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359869|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359870|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359871|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359872|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359873|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359874|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359875|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359876|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359877|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359878|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359958|NCT00730912|E2|Reported Event|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
359959|NCT00730912|E1|Reported Event|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
360218|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
359879|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359880|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359881|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359882|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359883|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359884|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359885|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359886|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359887|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359888|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359889|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359890|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359891|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359892|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359893|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359894|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359895|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359896|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359960|NCT00730847|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359961|NCT00730847|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359897|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359898|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359899|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359900|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359901|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359902|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359903|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359904|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359905|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359906|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359907|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359908|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359909|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359910|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359911|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359912|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359913|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359914|NCT00731094|E2|Reported Event|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
359962|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359963|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359915|NCT00731094|E1|Reported Event|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
359916|NCT00731055|B1|Baseline|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
359917|NCT00731055|P1|Participant Flow|Study Participants|This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
359918|NCT00731055|O4|Outcome|Varenicline 2.0 mg|The outcome of the session during which participant received varenicline 2.0 mg
359919|NCT00731055|O3|Outcome|Varenicline 1.0 mg|The outcome of the session during which participant received varenicline 1.0 mg
359920|NCT00731055|O2|Outcome|Varenicline 0.5 mg|The outcome of the session during which participant received varenicline 0.5 mg
359921|NCT00731055|O1|Outcome|Placebo|The outcome of the session during which participant received placebo
359922|NCT00731055|E1|Reported Event|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
359923|NCT00731042|B3|Baseline|Total|Total of all reporting groups
359924|NCT00731042|B2|Baseline|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
359925|NCT00731042|B1|Baseline|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
359926|NCT00731042|P2|Participant Flow|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
359927|NCT00731042|P1|Participant Flow|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
359928|NCT00731042|O2|Outcome|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
359929|NCT00731042|O1|Outcome|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
359930|NCT00731042|E2|Reported Event|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
359931|NCT00731042|E1|Reported Event|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
359932|NCT00730964|B1|Baseline|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
359933|NCT00730964|P1|Participant Flow|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
359934|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
359935|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
359936|NCT00730964|E1|Reported Event|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
359937|NCT00730925|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359938|NCT00730925|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359939|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359940|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359941|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359942|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359943|NCT00730925|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
359944|NCT00730912|B4|Baseline|Total|Total of all reporting groups
359945|NCT00730912|B3|Baseline|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
359946|NCT00730912|B2|Baseline|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
359947|NCT00730912|B1|Baseline|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
359948|NCT00730912|P3|Participant Flow|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
359949|NCT00730912|P2|Participant Flow|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
359950|NCT00730912|P1|Participant Flow|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
359951|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
359952|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
359953|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
359954|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
359955|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
360089|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
359964|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359965|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359966|NCT00730847|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
359967|NCT00730756|B3|Baseline|Total|Total of all reporting groups
359968|NCT00730756|B2|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359969|NCT00730756|B1|Baseline|Placebo|Vehicle placebo nasal spray once daily
359970|NCT00730756|P2|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359971|NCT00730756|P1|Participant Flow|Placebo|Vehicle placebo nasal spray once daily
359972|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359973|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359974|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359975|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359976|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359977|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359978|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359979|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359980|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359981|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359982|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359983|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359984|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359985|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359986|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359987|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359988|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359989|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
359990|NCT00730756|E2|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
359991|NCT00730756|E1|Reported Event|Placebo|Vehicle placebo nasal spray once daily
359992|NCT00730730|B1|Baseline|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359993|NCT00730730|P1|Participant Flow|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359994|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359995|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359996|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359997|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359998|NCT00730730|E1|Reported Event|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
359999|NCT00730691|B6|Baseline|Total|Total of all reporting groups
360000|NCT00730691|B5|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360001|NCT00730691|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360002|NCT00730691|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360003|NCT00730691|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360004|NCT00730691|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360005|NCT00730691|P5|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360006|NCT00730691|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360007|NCT00730691|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360008|NCT00730691|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360009|NCT00730691|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360010|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360216|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360011|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360012|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360013|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360014|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360015|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360016|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360017|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360018|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360019|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360020|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360021|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360022|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360023|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360024|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360025|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360026|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360027|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360028|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360029|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360030|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360031|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360032|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360033|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360034|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360035|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360036|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360037|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360038|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360039|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360040|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360041|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360042|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360043|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360044|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360045|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360046|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360047|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360048|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360049|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
361496|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
360050|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360051|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360052|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360053|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360054|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360055|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360056|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360057|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360058|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360059|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360060|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360061|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360062|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360063|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360064|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360065|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360066|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360067|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360068|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360069|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360070|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360071|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360072|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360073|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360074|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360075|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360076|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360077|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360078|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360079|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360080|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360081|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360082|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360083|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360084|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360085|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360086|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360087|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360088|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360090|NCT00730691|E5|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
360091|NCT00730691|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360092|NCT00730691|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
360093|NCT00730691|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
360094|NCT00730691|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
360095|NCT00730639|B6|Baseline|Total|Total of all reporting groups
360096|NCT00730639|B5|Baseline|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360097|NCT00730639|B4|Baseline|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360098|NCT00730639|B3|Baseline|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360099|NCT00730639|B2|Baseline|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360100|NCT00730639|B1|Baseline|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360101|NCT00730639|P5|Participant Flow|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
360102|NCT00730639|P4|Participant Flow|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
360103|NCT00730639|P3|Participant Flow|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
360104|NCT00730639|P2|Participant Flow|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
360105|NCT00730639|P1|Participant Flow|0.1 mg/kg Nivolumab|0.1 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg)was administered intravenously (IV) every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, partial response (PR), or stable disease (SD), who subsequently experienced confirmed PD.
360106|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360107|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360108|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360109|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360110|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360111|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360112|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360113|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360114|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360115|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360116|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360117|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360118|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360119|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
361631|NCT00726453|B3|Baseline|Total|Total of all reporting groups
360120|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360121|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360122|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360123|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360124|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360125|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360126|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360127|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360128|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360129|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360130|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360131|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360132|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360133|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360134|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360135|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
360136|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360137|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360138|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360139|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360140|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360141|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360142|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360143|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360144|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360145|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360217|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
360146|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360147|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
360148|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360149|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360150|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360151|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360152|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360153|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360154|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360155|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360156|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360157|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360158|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360159|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360160|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360161|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360162|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360163|NCT00730639|E5|Reported Event|10 mg/kg Nivolumab|IV solution of 10 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360164|NCT00730639|E4|Reported Event|3 mg/kg Nivolumab|IV solution of 3 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360165|NCT00730639|E3|Reported Event|1 mg/kg Nivolumab|IV solution of 1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360166|NCT00730639|E2|Reported Event|0.3 mg/kg Nivolumab|IV solution of 0.3 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360167|NCT00730639|E1|Reported Event|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
360168|NCT00730327|B3|Baseline|Total|Total of all reporting groups
360169|NCT00730327|B2|Baseline|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360170|NCT00730327|B1|Baseline|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360171|NCT00730327|P2|Participant Flow|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360172|NCT00730327|P1|Participant Flow|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360173|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360174|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360175|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360176|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360177|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360178|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360179|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360180|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360181|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360182|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360183|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360184|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360185|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360186|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360187|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360188|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360189|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360190|NCT00730327|E2|Reported Event|Control|Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
360191|NCT00730327|E1|Reported Event|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
360192|NCT00730275|B5|Baseline|Total|Total of all reporting groups
360193|NCT00730275|B4|Baseline|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
360194|NCT00730275|B3|Baseline|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360195|NCT00730275|B2|Baseline|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360196|NCT00730275|B1|Baseline|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360197|NCT00730275|P4|Participant Flow|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
360198|NCT00730275|P3|Participant Flow|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360199|NCT00730275|P2|Participant Flow|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360200|NCT00730275|P1|Participant Flow|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360201|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
360202|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360203|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360204|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360205|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360206|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360207|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360208|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360209|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360210|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360211|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360212|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360213|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360214|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360215|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360219|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360220|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360221|NCT00730275|E4|Reported Event|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
360222|NCT00730275|E3|Reported Event|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
360223|NCT00730275|E2|Reported Event|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
360224|NCT00730275|E1|Reported Event|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
360225|NCT00730236|B1|Baseline|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360226|NCT00730236|P1|Participant Flow|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360227|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360228|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360229|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360230|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360231|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360232|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360233|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360234|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360235|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360236|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360237|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360238|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360239|NCT00730236|E1|Reported Event|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
360240|NCT00730132|B1|Baseline|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
360241|NCT00730132|P1|Participant Flow|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
360242|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
360243|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
360244|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
360275|NCT00730041|E2|Reported Event|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
363682|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
360245|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
360246|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
360247|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
360248|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
360249|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
360250|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
360251|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
360252|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
360253|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
360254|NCT00730132|O1|Outcome|All Participants Analyzed|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
360255|NCT00730132|E1|Reported Event|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
360256|NCT00730041|B3|Baseline|Total|Total of all reporting groups
360257|NCT00730041|B2|Baseline|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360258|NCT00730041|B1|Baseline|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360259|NCT00730041|P2|Participant Flow|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360260|NCT00730041|P1|Participant Flow|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360261|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360262|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360263|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360264|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360265|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360266|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360267|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360268|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360269|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360270|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360271|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360272|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360273|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
360274|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360276|NCT00730041|E1|Reported Event|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
360277|NCT00730028|B6|Baseline|Total|Total of all reporting groups
360278|NCT00730028|B5|Baseline|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360279|NCT00730028|B4|Baseline|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360280|NCT00730028|B3|Baseline|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360281|NCT00730028|B2|Baseline|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360282|NCT00730028|B1|Baseline|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360283|NCT00730028|P5|Participant Flow|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360284|NCT00730028|P4|Participant Flow|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360285|NCT00730028|P3|Participant Flow|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360286|NCT00730028|P2|Participant Flow|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360287|NCT00730028|P1|Participant Flow|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360288|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360289|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360290|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360291|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360292|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360293|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360294|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360475|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360295|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360296|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360297|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360298|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360299|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360300|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360301|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360302|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360303|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360304|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360305|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360306|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360307|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360308|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360309|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360310|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360311|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360331|NCT00730028|E2|Reported Event|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
364129|NCT00719706|E2|Reported Event|Placebo|Participants taking placebo.
360312|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360313|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360314|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360315|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360316|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360317|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360318|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360319|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360320|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360321|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360322|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360323|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
360324|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360325|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360326|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360327|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360328|NCT00730028|E5|Reported Event|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
360329|NCT00730028|E4|Reported Event|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
360330|NCT00730028|E3|Reported Event|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360332|NCT00730028|E1|Reported Event|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
360333|NCT00730015|B4|Baseline|Total|Total of all reporting groups
360334|NCT00730015|B3|Baseline|Placebo|Dose matched placebo, oral administration, once per day
360335|NCT00730015|B2|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360336|NCT00730015|B1|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360337|NCT00730015|P3|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day
360338|NCT00730015|P2|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360339|NCT00730015|P1|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360340|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360341|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360342|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360343|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360344|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360345|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360346|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360347|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360348|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360349|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360350|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360351|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360352|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360353|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360354|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360355|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360356|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360357|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360358|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360359|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360360|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360361|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
360362|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
360363|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
360364|NCT00730015|E8|Reported Event|Linaclotide 290μg to Linaclotide 290μg RW Period|Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
360365|NCT00730015|E7|Reported Event|Linaclotide 290μg to Placebo RW Period|Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
360366|NCT00730015|E6|Reported Event|Linaclotide 145μg to Linaclotide 145μg RW Period|Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
360367|NCT00730015|E5|Reported Event|Linaclotide 145μg to Placebo RW Period|Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
360368|NCT00730015|E4|Reported Event|Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period|Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
360369|NCT00730015|E3|Reported Event|Placebo|Dose matched placebo, oral administration, once per day
360370|NCT00730015|E2|Reported Event|Linaclotide 290μg|Linaclotide, 290μg dose, oral administration, once per day
360371|NCT00730015|E1|Reported Event|Linaclotide 145μg|Linaclotide, 145μg dose, oral administration, once per day
360372|NCT00729937|B7|Baseline|Total|Total of all reporting groups
360373|NCT00729937|B6|Baseline|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360374|NCT00729937|B5|Baseline|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360375|NCT00729937|B4|Baseline|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360376|NCT00729937|B3|Baseline|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360377|NCT00729937|B2|Baseline|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360378|NCT00729937|B1|Baseline|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360379|NCT00729937|P6|Participant Flow|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360741|NCT00729560|P1|Participant Flow|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
360380|NCT00729937|P5|Participant Flow|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360381|NCT00729937|P4|Participant Flow|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360382|NCT00729937|P3|Participant Flow|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360383|NCT00729937|P2|Participant Flow|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360384|NCT00729937|P1|Participant Flow|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360385|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360386|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360387|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360388|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360389|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360390|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360391|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360392|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360393|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360394|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360395|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360396|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360397|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360398|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360399|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360400|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360401|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360402|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360403|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360404|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360405|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360406|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360407|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360408|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360409|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360410|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
361497|NCT00727025|E2|Reported Event|Wounds Closed With Suture|wound segments closed with traditional suture
360411|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360412|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360413|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360414|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360415|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360416|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360417|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360418|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360419|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360420|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360421|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360422|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360423|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360424|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360425|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360426|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360427|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360428|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360429|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360430|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360431|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360432|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360433|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360434|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360435|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360436|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360437|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360438|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360439|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360440|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360441|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360473|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360442|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360443|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360444|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360445|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360446|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360447|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360448|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360449|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360450|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360451|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360452|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360453|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360454|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360455|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360456|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360457|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360458|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360459|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360460|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360461|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360462|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360463|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360464|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360465|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360466|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360467|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360468|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360469|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360470|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360471|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360472|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360474|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360476|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360477|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360478|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360479|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360480|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360481|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360482|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360483|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360484|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360485|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360486|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360487|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360488|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360489|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360490|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360491|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360492|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360493|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360494|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360495|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360496|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360497|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360498|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360499|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360500|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360501|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360502|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360503|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360504|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360505|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360506|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360857|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360507|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360508|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360509|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360510|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360511|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360512|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360513|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360514|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360515|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360516|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360517|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360518|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360519|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360520|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360521|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360522|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360523|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360524|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360525|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360526|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360527|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360528|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360529|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360530|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360531|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360532|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360533|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360534|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360535|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360536|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360537|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360569|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360538|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360539|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360540|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360541|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360542|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360543|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360544|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360545|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360546|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360547|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360548|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360549|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360550|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360551|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360552|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360553|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360554|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360555|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360556|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360557|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360558|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360559|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360560|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360561|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360562|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360563|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360564|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360565|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360566|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360567|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360568|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360570|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360571|NCT00729937|E6|Reported Event|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
360572|NCT00729937|E5|Reported Event|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360573|NCT00729937|E4|Reported Event|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
360574|NCT00729937|E3|Reported Event|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
360575|NCT00729937|E2|Reported Event|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
360576|NCT00729937|E1|Reported Event|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
360577|NCT00729924|B1|Baseline|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
360578|NCT00729924|P1|Participant Flow|Raltegravir 400mg Orally Every 12 Hours for 7 Days.|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
360579|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
360580|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
360581|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
360582|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
360583|NCT00729924|E1|Reported Event|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
360584|NCT00729859|B4|Baseline|Total|Total of all reporting groups
360585|NCT00729859|B3|Baseline|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
360586|NCT00729859|B2|Baseline|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
360587|NCT00729859|B1|Baseline|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
360588|NCT00729859|P3|Participant Flow|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
360589|NCT00729859|P2|Participant Flow|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
360590|NCT00729859|P1|Participant Flow|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
360591|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360592|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360593|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360594|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360595|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360596|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360597|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360598|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360599|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360600|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360601|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360602|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360603|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360604|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360605|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360606|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360607|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360608|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360609|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360610|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360611|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360612|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
360613|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360614|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360615|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
360616|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360617|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360618|NCT00729859|O3|Outcome|Group 3: Acyline + T-gel + Oral Anastrozole 1mg|Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
360619|NCT00729859|O2|Outcome|Group 2: Acyline + T-gel 10g/Day + Placebo Pill|Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days
360620|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel + Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
360621|NCT00729859|E3|Reported Event|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
360622|NCT00729859|E2|Reported Event|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
360623|NCT00729859|E1|Reported Event|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
360624|NCT00729846|B3|Baseline|Total|Total of all reporting groups
360625|NCT00729846|B2|Baseline|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
360626|NCT00729846|B1|Baseline|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
360627|NCT00729846|P2|Participant Flow|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
360628|NCT00729846|P1|Participant Flow|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
360629|NCT00729846|O2|Outcome|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
360630|NCT00729846|O1|Outcome|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
360631|NCT00729846|E2|Reported Event|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
360632|NCT00729846|E1|Reported Event|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
360633|NCT00729833|B1|Baseline|Figitumumab + Sunitinib (All Combined)|All participants who received at least one dose of figitumumab plus sunitinib.
360634|NCT00729833|P4|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.
360635|NCT00729833|P3|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
360636|NCT00729833|P2|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
361498|NCT00727025|E1|Reported Event|Wounds Closed With Device|segment of wounds closed with steri-strip device
360637|NCT00729833|P1|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
360638|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360639|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360640|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360641|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360642|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360643|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360644|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360645|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360646|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360647|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360648|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360649|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360650|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360651|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360652|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360653|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360654|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
360655|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360656|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360657|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360658|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360659|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360660|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360661|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360689|NCT00729690|P3|Participant Flow|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360662|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360663|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360664|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360665|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360666|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360667|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360668|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360669|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360670|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360671|NCT00729833|E4|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
360672|NCT00729833|E3|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360673|NCT00729833|E2|Reported Event|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
360674|NCT00729833|E1|Reported Event|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
360675|NCT00729807|B1|Baseline|Treatment Arm|
360676|NCT00729807|P1|Participant Flow|Treatment Arm|
360677|NCT00729807|O1|Outcome|Treatment Arm|Pentamidine
360678|NCT00729807|E1|Reported Event|Treatment Arm|Pentamidine
360679|NCT00729781|B1|Baseline|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360680|NCT00729781|P1|Participant Flow|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360681|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360682|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360683|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360684|NCT00729781|E1|Reported Event|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
360685|NCT00729690|B4|Baseline|Total|Total of all reporting groups
360686|NCT00729690|B3|Baseline|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360687|NCT00729690|B2|Baseline|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360688|NCT00729690|B1|Baseline|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
361499|NCT00726999|B3|Baseline|Total|Total of all reporting groups
360690|NCT00729690|P2|Participant Flow|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360691|NCT00729690|P1|Participant Flow|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360692|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360693|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360694|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360695|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360696|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360697|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360698|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360699|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360700|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360701|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360702|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360703|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360704|NCT00729690|E3|Reported Event|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
360705|NCT00729690|E2|Reported Event|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
360706|NCT00729690|E1|Reported Event|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
360707|NCT00729677|B1|Baseline|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360708|NCT00729677|P1|Participant Flow|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360709|NCT00729677|O2|Outcome|Participants on 3-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
360710|NCT00729677|O1|Outcome|Participants on 2-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
360711|NCT00729677|O2|Outcome|Participants With No History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had no history of nausea.
360712|NCT00729677|O1|Outcome|Participants With History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had history of nausea.
360713|NCT00729677|O1|Outcome|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360714|NCT00729677|O3|Outcome|Transgender|transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360715|NCT00729677|O2|Outcome|Males|males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360716|NCT00729677|O1|Outcome|Females|females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360717|NCT00729677|E1|Reported Event|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
360718|NCT00729651|B3|Baseline|Total|Total of all reporting groups
360719|NCT00729651|B2|Baseline|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
360720|NCT00729651|B1|Baseline|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
360721|NCT00729651|P2|Participant Flow|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
360722|NCT00729651|P1|Participant Flow|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
363683|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
360723|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360724|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360725|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360726|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360727|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360728|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360729|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360730|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
360731|NCT00729651|E2|Reported Event|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
360732|NCT00729651|E1|Reported Event|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
360733|NCT00729612|B1|Baseline|Treatment (Nab-paclitaxel, Carboplatin)|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~carboplatin~paclitaxel albumin-stabilized nanoparticle formulation~protein expression analysis~immunoenzyme technique~immunohistochemistry staining method~laboratory biomarker analysis"
360734|NCT00729612|P1|Participant Flow|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360735|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360736|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360737|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360738|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360739|NCT00729612|E1|Reported Event|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
360740|NCT00729560|B1|Baseline|Flutamide Treated and Placebo Control|Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
363684|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
360742|NCT00729560|O1|Outcome|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
360743|NCT00729560|E1|Reported Event|Flutamide Treated and Placebo Control Subjects|Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
360744|NCT00729521|B4|Baseline|Total|Total of all reporting groups
360745|NCT00729521|B3|Baseline|Facilitative System|"a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
360746|NCT00729521|B2|Baseline|Standard Program|"a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
360747|NCT00729521|B1|Baseline|Control|a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
360748|NCT00729521|P3|Participant Flow|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
360749|NCT00729521|P2|Participant Flow|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
360750|NCT00729521|P1|Participant Flow|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
360751|NCT00729521|O3|Outcome|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
360752|NCT00729521|O2|Outcome|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
360753|NCT00729521|O1|Outcome|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
360754|NCT00729521|E3|Reported Event|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
360755|NCT00729521|E2|Reported Event|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
360756|NCT00729521|E1|Reported Event|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
360757|NCT00729482|B1|Baseline|RAD001|Treatment Arm (RAD001)
360758|NCT00729482|P1|Participant Flow|RAD001|Treatment Arm (RAD001)
360759|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
360760|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
360761|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
360762|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
360763|NCT00729482|E1|Reported Event|RAD001|Treatment Arm (RAD001)
360764|NCT00729469|B3|Baseline|Total|Total of all reporting groups
360765|NCT00729469|B2|Baseline|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360766|NCT00729469|B1|Baseline|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360767|NCT00729469|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360768|NCT00729469|P1|Participant Flow|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360769|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360770|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360771|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360772|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360773|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360774|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360775|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360776|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360777|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360778|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360779|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360780|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360781|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360782|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360783|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360784|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360785|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360786|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360787|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360788|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360789|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360790|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360791|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360792|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360793|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360794|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360795|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360796|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360797|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360798|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360799|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360800|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360801|NCT00729469|E2|Reported Event|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360802|NCT00729469|E1|Reported Event|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
360803|NCT00729365|B4|Baseline|Total|Total of all reporting groups
360804|NCT00729365|B3|Baseline|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
360805|NCT00729365|B2|Baseline|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
360806|NCT00729365|B1|Baseline|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
360807|NCT00729365|P3|Participant Flow|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
360808|NCT00729365|P2|Participant Flow|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
360809|NCT00729365|P1|Participant Flow|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
360810|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
360811|NCT00729365|O2|Outcome|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
360812|NCT00729365|O1|Outcome|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
360813|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
360814|NCT00729365|O2|Outcome|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
360815|NCT00729365|O1|Outcome|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
360816|NCT00729365|E3|Reported Event|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
360858|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360817|NCT00729365|E2|Reported Event|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
360818|NCT00729365|E1|Reported Event|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
360819|NCT00729326|B3|Baseline|Total|Total of all reporting groups
360820|NCT00729326|B2|Baseline|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360821|NCT00729326|B1|Baseline|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360822|NCT00729326|P2|Participant Flow|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360823|NCT00729326|P1|Participant Flow|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360824|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360825|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360826|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360827|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360828|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360829|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360830|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360831|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360832|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360833|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360834|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360835|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360836|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360837|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360838|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360839|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360840|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360841|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360842|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360843|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360844|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360845|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360846|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360847|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360848|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360849|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360850|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360851|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360852|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360853|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360854|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360855|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360856|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360859|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360860|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360861|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360862|NCT00729326|E2|Reported Event|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
360863|NCT00729326|E1|Reported Event|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
360864|NCT00729248|B1|Baseline|All Participants|"All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
360865|NCT00729248|P1|Participant Flow|Participants|12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
360866|NCT00729248|O2|Outcome|MLRs in the Presence of SRL|"All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination:~Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
360867|NCT00729248|O1|Outcome|MLRs in the Presence of TAC|"All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~REcipient PMBC + Donor PBMC + Tacrolimus (TAC)"
360868|NCT00729248|E1|Reported Event|All Participants|All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
360869|NCT00728988|B3|Baseline|Total|Total of all reporting groups
360870|NCT00728988|B2|Baseline|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360871|NCT00728988|B1|Baseline|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360872|NCT00728988|P2|Participant Flow|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360873|NCT00728988|P1|Participant Flow|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360874|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360875|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360876|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360877|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
360878|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360879|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
360880|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360881|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360882|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360883|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360884|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360885|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360886|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360887|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
363685|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
360888|NCT00728988|E2|Reported Event|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
360889|NCT00728988|E1|Reported Event|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
360890|NCT00728962|B1|Baseline|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
360891|NCT00728962|P1|Participant Flow|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
360892|NCT00728962|O1|Outcome|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
360893|NCT00728962|E1|Reported Event|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
360894|NCT00728923|B1|Baseline|Minocycline|minocycline 100mg bid for 12 weeks
360895|NCT00728923|P1|Participant Flow|Minocycline|minocycline 100mg bid for 12 weeks
360896|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
360897|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
360898|NCT00728923|E1|Reported Event|Minocycline|minocycline 100mg bid for 12 weeks
360899|NCT00728910|B1|Baseline|Group 1|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks.
360900|NCT00728910|P1|Participant Flow|Atorvastatin/ABT335/Niaspan|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks, for a total study duration of 22 weeks
360901|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks followed by an oral fat tolerance test.
360902|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks followed by an oral fat tolerance test.
360903|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by an oral fat tolerance test
360904|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
360905|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
360906|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
360907|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
360908|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
360909|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
360910|NCT00728910|E1|Reported Event|Atorvastatin/ABT335/Niaspan|Subjects received atorvastatin 10 mg/day for 4 weeks, followed by addition of ABT335 135 mg/day for a further 8 weeks followed by the addition of Niaspan 2000 mg/day for a further 10 weeks.
360911|NCT00728884|B1|Baseline|Certain Prevail Implants|Osseotite surfaced implants with internal connection
360912|NCT00728884|P1|Participant Flow|Certain Prevail Implants|Osseotite surfaced implants with internal connection
360913|NCT00728884|O1|Outcome|Certain Prevail Implants|Osseotite surfaced implants with internal connection
360914|NCT00728884|E1|Reported Event|Certain Prevail Implants|Osseotite surfaced implants with internal connection
360915|NCT00728845|B3|Baseline|Total|Total of all reporting groups
360916|NCT00728845|B2|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360917|NCT00728845|B1|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360918|NCT00728845|P2|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360919|NCT00728845|P1|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360920|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360921|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360922|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360923|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
363686|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
360924|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360925|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360926|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360927|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360928|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360929|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360930|NCT00728845|E2|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360931|NCT00728845|E1|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
360932|NCT00728754|B3|Baseline|Total|Total of all reporting groups
360933|NCT00728754|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
360934|NCT00728754|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
360935|NCT00728754|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
360936|NCT00728754|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
360937|NCT00728754|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
360938|NCT00728754|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
360939|NCT00728754|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
360940|NCT00728754|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
360941|NCT00728728|B3|Baseline|Total|Total of all reporting groups
360942|NCT00728728|B2|Baseline|Arm 2: Placebo|Placebo control group
360943|NCT00728728|B1|Baseline|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360944|NCT00728728|P2|Participant Flow|Arm 2: Placebo|Placebo control group
360945|NCT00728728|P1|Participant Flow|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360946|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360947|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360948|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360949|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360950|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360951|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360952|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo: Placebo
360953|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360954|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360955|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360956|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360957|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360958|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
360959|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
360960|NCT00728728|E2|Reported Event|Arm 2: Placebo|"Placebo~Placebo: Placebo"
361027|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
361028|NCT00728416|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
360961|NCT00728728|E1|Reported Event|Arm 1: Pregnenolone|"Pregnenolone~Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial."
360962|NCT00728689|B3|Baseline|Total|Total of all reporting groups
360963|NCT00728689|B2|Baseline|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360964|NCT00728689|B1|Baseline|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360965|NCT00728689|P2|Participant Flow|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360966|NCT00728689|P1|Participant Flow|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360967|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360968|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360969|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360970|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360971|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360972|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360973|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360974|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360975|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360976|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360977|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360978|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
360979|NCT00728689|E2|Reported Event|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360980|NCT00728689|E1|Reported Event|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
360981|NCT00728494|B3|Baseline|Total|Total of all reporting groups
360982|NCT00728494|B2|Baseline|Treatment Alone|PegIntron/Rebetol treatment only
360983|NCT00728494|B1|Baseline|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360984|NCT00728494|P2|Participant Flow|Treatment Alone|PegIntron/Rebetol treatment only
360985|NCT00728494|P1|Participant Flow|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360986|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
360987|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360988|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
360989|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360990|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
361029|NCT00728416|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
361049|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
360991|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360992|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
360993|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360994|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
360995|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360996|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
360997|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
360998|NCT00728494|E2|Reported Event|Treatment Alone|
360999|NCT00728494|E1|Reported Event|Treatment and Patient Assistance Program|
361000|NCT00728481|B3|Baseline|Total|Total of all reporting groups
361001|NCT00728481|B2|Baseline|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361002|NCT00728481|B1|Baseline|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361003|NCT00728481|P2|Participant Flow|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361004|NCT00728481|P1|Participant Flow|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361005|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361006|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361007|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361008|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361009|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361010|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361011|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361012|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361013|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361014|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361015|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361016|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361017|NCT00728481|E2|Reported Event|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
361018|NCT00728481|E1|Reported Event|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
361019|NCT00728416|B3|Baseline|Total|Total of all reporting groups
361020|NCT00728416|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
361021|NCT00728416|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
361022|NCT00728416|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
361023|NCT00728416|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
361024|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
361025|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
361026|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
361030|NCT00728260|B1|Baseline|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361031|NCT00728260|P1|Participant Flow|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361032|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361033|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361034|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361035|NCT00728260|E1|Reported Event|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
361036|NCT00728182|B3|Baseline|Total|Total of all reporting groups
361037|NCT00728182|B2|Baseline|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361038|NCT00728182|B1|Baseline|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361039|NCT00728182|P2|Participant Flow|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361040|NCT00728182|P1|Participant Flow|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361041|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361042|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361043|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361044|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361045|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361046|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361047|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361048|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361050|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361051|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361052|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361053|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361054|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361055|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361056|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361057|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361058|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361059|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361060|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361061|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361062|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361063|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361064|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361065|NCT00728182|E2|Reported Event|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
361066|NCT00728182|E1|Reported Event|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
361067|NCT00728130|B1|Baseline|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
361068|NCT00728130|P1|Participant Flow|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
361069|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
361070|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
361071|NCT00728130|E1|Reported Event|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
361072|NCT00727961|B1|Baseline|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361073|NCT00727961|P1|Participant Flow|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361074|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361075|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361076|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361077|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361078|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361079|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361080|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
361081|NCT00727961|E1|Reported Event|Caelyx Intravenous|
361082|NCT00727909|B1|Baseline|All Study Participants|All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
361083|NCT00727909|P4|Participant Flow|RITA RITE TC|Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
361084|NCT00727909|P3|Participant Flow|RITE RITA TC|Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.
361133|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
363687|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
361085|NCT00727909|P2|Participant Flow|TC RITA RITE|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.
361086|NCT00727909|P1|Participant Flow|TC RITE RITA|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.
361087|NCT00727909|O1|Outcome|All Participants|All participants received all three hearing aid treatments.
361088|NCT00727909|E1|Reported Event|All Study Participants|All participants received all three hearing aid treatments.
361089|NCT00727857|B4|Baseline|Total|Total of all reporting groups
361090|NCT00727857|B3|Baseline|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361091|NCT00727857|B2|Baseline|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361092|NCT00727857|B1|Baseline|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361093|NCT00727857|P3|Participant Flow|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361094|NCT00727857|P2|Participant Flow|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361095|NCT00727857|P1|Participant Flow|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361096|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361097|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361098|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361099|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361100|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361101|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361102|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361103|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361104|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361105|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361106|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361107|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361108|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361109|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361110|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361111|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361112|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361113|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361114|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361115|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361116|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361117|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361118|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361119|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361120|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361121|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361122|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361123|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361124|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361125|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361126|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361127|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361128|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361129|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361130|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361131|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361132|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
363688|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
361134|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361135|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361136|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361137|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361138|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361139|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361140|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361141|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361142|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361143|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361144|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361145|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361146|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361147|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361148|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361149|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361150|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361151|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361152|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361153|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361154|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361155|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361156|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361157|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361158|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361159|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361160|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361161|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361162|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361163|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361164|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361165|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361166|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361167|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361168|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361169|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361170|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361171|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361172|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361173|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361174|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361175|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361176|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361177|NCT00727857|E3|Reported Event|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
361178|NCT00727857|E2|Reported Event|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
361179|NCT00727857|E1|Reported Event|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
361180|NCT00727844|B3|Baseline|Total|Total of all reporting groups
361215|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361181|NCT00727844|B2|Baseline|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
361182|NCT00727844|B1|Baseline|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
361183|NCT00727844|P4|Participant Flow|2nd Randomization: Linezolid 300 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
361184|NCT00727844|P3|Participant Flow|2nd Randomization: Linezolid 600 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
361185|NCT00727844|P2|Participant Flow|Initial Randomization: Delayed Start Linezolid|Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added.
361186|NCT00727844|P1|Participant Flow|Initial Randomization: Immediate Start Linezolid|Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen.
361187|NCT00727844|O2|Outcome|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
361188|NCT00727844|O1|Outcome|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
361189|NCT00727844|E1|Reported Event|Clinically Significant AEs|All clinically significant adverse events, regardless of relationship to linezolid. This includes all SAEs, all AEs grade 3 and above, and all neuropathies grade 2 and above.
361190|NCT00727740|B3|Baseline|Total|Total of all reporting groups
361191|NCT00727740|B2|Baseline|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
361192|NCT00727740|B1|Baseline|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
361193|NCT00727740|P2|Participant Flow|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
361194|NCT00727740|P1|Participant Flow|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
361195|NCT00727740|O2|Outcome|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
361444|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361196|NCT00727740|O1|Outcome|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
361197|NCT00727740|E2|Reported Event|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
361198|NCT00727740|E1|Reported Event|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
361199|NCT00727714|B1|Baseline|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361200|NCT00727714|P1|Participant Flow|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361201|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361202|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361203|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361204|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361205|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361206|NCT00727714|E1|Reported Event|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
361207|NCT00726622|B3|Baseline|Total|Total of all reporting groups
361208|NCT00726622|B2|Baseline|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361209|NCT00726622|B1|Baseline|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361210|NCT00726622|P2|Participant Flow|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361211|NCT00726622|P1|Participant Flow|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361212|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361213|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361214|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361272|NCT00727597|E1|Reported Event|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
361216|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361217|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361218|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361219|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361220|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361221|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361222|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361223|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361224|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
361225|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
361226|NCT00726622|E2|Reported Event|Arm 2: Laparoscopic-assisted Rectal Resection|Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
361227|NCT00726622|E1|Reported Event|Arm 1: Open Laparotomy and Rectal Resection|Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.
361228|NCT00726609|B1|Baseline|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
361229|NCT00726609|P1|Participant Flow|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
361230|NCT00726609|O1|Outcome|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
361231|NCT00726609|E1|Reported Event|Posaconazole (Assigned by Physician in Normal Practice)|
361232|NCT00727649|B3|Baseline|Total|Total of all reporting groups
361233|NCT00727649|B2|Baseline|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg pill~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361234|NCT00727649|B1|Baseline|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy"
361235|NCT00727649|P2|Participant Flow|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361236|NCT00727649|P1|Participant Flow|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361273|NCT00727571|B5|Baseline|Total|Total of all reporting groups
365101|NCT00716742|E1|Reported Event|Lumigan®|bimatoprost 0.03%
361237|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361238|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361239|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361240|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361241|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361242|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361243|NCT00727649|E4|Reported Event|L1P2 (Psyllium Second); 2nd 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361244|NCT00727649|E3|Reported Event|P1L2 (Loperamide Second); 2nd 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361245|NCT00727649|E2|Reported Event|L1P2 (Loperamide First): 1st 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
361246|NCT00727649|E1|Reported Event|P1L2 (Psyllium First); 1st 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
361247|NCT00727636|B3|Baseline|Total|Total of all reporting groups
361248|NCT00727636|B2|Baseline|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361249|NCT00727636|B1|Baseline|Prospective Cohort|Received Gardasil as part of study
361250|NCT00727636|P2|Participant Flow|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361251|NCT00727636|P1|Participant Flow|Prospective Cohort|Received Gardasil as part of study
361252|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361253|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
361254|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361255|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
361256|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361257|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
361258|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361259|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
361260|NCT00727636|E2|Reported Event|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
361261|NCT00727636|E1|Reported Event|Prospective Cohort|Received Gardasil as part of study
361262|NCT00727597|B3|Baseline|Total|Total of all reporting groups
361263|NCT00727597|B2|Baseline|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
361264|NCT00727597|B1|Baseline|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
361265|NCT00727597|P2|Participant Flow|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
361266|NCT00727597|P1|Participant Flow|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
361267|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
361268|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
361269|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
361270|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
361271|NCT00727597|E2|Reported Event|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
363689|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
361274|NCT00727571|B4|Baseline|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361275|NCT00727571|B3|Baseline|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361276|NCT00727571|B2|Baseline|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361277|NCT00727571|B1|Baseline|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361278|NCT00727571|P4|Participant Flow|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
361279|NCT00727571|P3|Participant Flow|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
361280|NCT00727571|P2|Participant Flow|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
361281|NCT00727571|P1|Participant Flow|No CKD or Anemia|Chronic kidney disease (CKD) is based on an estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
361282|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361283|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361284|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361285|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361286|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361287|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361288|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361289|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361290|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361291|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361292|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361293|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361294|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361295|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361296|NCT00727571|O2|Outcome|No CKD But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361297|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361298|NCT00727571|O1|Outcome|All Enrolled Participants|
361299|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361300|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361301|NCT00727571|E4|Reported Event|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
361302|NCT00727571|E3|Reported Event|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361303|NCT00727571|E2|Reported Event|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361304|NCT00727571|E1|Reported Event|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
361305|NCT00727558|B3|Baseline|Total|Total of all reporting groups
361306|NCT00727558|B2|Baseline|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361307|NCT00727558|B1|Baseline|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361308|NCT00727558|P2|Participant Flow|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361309|NCT00727558|P1|Participant Flow|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361310|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361311|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361312|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361313|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361314|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361315|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361316|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361317|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361318|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361319|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361320|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361321|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361322|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361323|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361324|NCT00727558|E2|Reported Event|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
361325|NCT00727558|E1|Reported Event|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
361326|NCT00727506|B7|Baseline|Total|Total of all reporting groups
361327|NCT00727506|B6|Baseline|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361328|NCT00727506|B5|Baseline|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
361329|NCT00727506|B4|Baseline|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361330|NCT00727506|B3|Baseline|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361331|NCT00727506|B2|Baseline|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361332|NCT00727506|B1|Baseline|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361333|NCT00727506|P6|Participant Flow|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361334|NCT00727506|P5|Participant Flow|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
361335|NCT00727506|P4|Participant Flow|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361336|NCT00727506|P3|Participant Flow|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361337|NCT00727506|P2|Participant Flow|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361338|NCT00727506|P1|Participant Flow|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361339|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361340|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361341|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361342|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361343|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361344|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361345|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361346|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
361347|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361348|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361349|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
361350|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361351|NCT00727506|E6|Reported Event|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361352|NCT00727506|E5|Reported Event|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
361353|NCT00727506|E4|Reported Event|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
361354|NCT00727506|E3|Reported Event|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361355|NCT00727506|E2|Reported Event|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361356|NCT00727506|E1|Reported Event|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
361357|NCT00727402|B1|Baseline|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
361358|NCT00727402|P1|Participant Flow|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
361359|NCT00727402|O1|Outcome|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
361360|NCT00727402|E1|Reported Event|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
361361|NCT00727337|B5|Baseline|Total|Total of all reporting groups
361362|NCT00727337|B4|Baseline|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
361363|NCT00727337|B3|Baseline|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
361364|NCT00727337|B2|Baseline|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
361365|NCT00727337|B1|Baseline|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
361366|NCT00727337|P4|Participant Flow|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
361367|NCT00727337|P3|Participant Flow|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
361368|NCT00727337|P2|Participant Flow|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
361369|NCT00727337|P1|Participant Flow|LACE - COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
361370|NCT00727337|O4|Outcome|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
361371|NCT00727337|O3|Outcome|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
361372|NCT00727337|O2|Outcome|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
361373|NCT00727337|O1|Outcome|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
361374|NCT00727337|E4|Reported Event|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
361375|NCT00727337|E3|Reported Event|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
361376|NCT00727337|E2|Reported Event|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
361377|NCT00727337|E1|Reported Event|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
361378|NCT00727311|B1|Baseline|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361379|NCT00727311|P1|Participant Flow|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361380|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361443|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361445|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361381|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361382|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361383|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
361384|NCT00727311|E1|Reported Event|All Participants|
361385|NCT00727298|B1|Baseline|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361386|NCT00727298|P1|Participant Flow|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361387|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361388|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361389|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361390|NCT00727298|E1|Reported Event|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
361391|NCT00727272|B1|Baseline|Entire Study Population|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361392|NCT00727272|P3|Participant Flow|Treatment Sequence CAB|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361393|NCT00727272|P2|Participant Flow|Treatment Sequence BCA|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361394|NCT00727272|P1|Participant Flow|Treatment Sequence ABC|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361395|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
361396|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
361397|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
361398|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361399|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
361400|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
361401|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
361402|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361403|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
361404|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
361405|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
361406|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361492|NCT00727025|O1|Outcome|Steri-strip Closure|
369110|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
361407|NCT00727272|E3|Reported Event|Treatment C - Quinine Sulfate Capsules 324 mg - Fed|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361408|NCT00727272|E2|Reported Event|Treatment B - Quinine Sulphate Tablets 300 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361409|NCT00727272|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 324 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361410|NCT00727259|B1|Baseline|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
361411|NCT00727259|P1|Participant Flow|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
361412|NCT00727259|O2|Outcome|After 3 Months of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
361413|NCT00727259|O1|Outcome|After 1 Month of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
361414|NCT00727259|E1|Reported Event|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
361415|NCT00727194|B1|Baseline|Overall Study|"Eculizumab:~Eculizumab [600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)].~Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.~Placebo:~Matching placebo [IV weekly (4 doses) followed by IV every other week (7 doses)] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks."
361416|NCT00727194|P3|Participant Flow|Not Randomized/Screen Failures|Not randomized; not treatment cohort
361417|NCT00727194|P2|Participant Flow|Placebo to Eculizumab Sequence|"Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses).~Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses).~Period 1: patients received placebo for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received eculizumab for 16 weeks."
361418|NCT00727194|P1|Participant Flow|Eculizumab to Placebo Sequence|"Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)~Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses)~Period 1: patients received eculizumab for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received placebo for 16 weeks."
361419|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
361420|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
361421|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
361422|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
361423|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361424|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361425|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361426|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361427|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361428|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361429|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361430|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361431|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361432|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361433|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361434|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361435|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361436|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361437|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361438|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361439|NCT00727194|O4|Outcome|Placebo Period 2|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361440|NCT00727194|O3|Outcome|Eculizumab Period 2|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361441|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361442|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361446|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361447|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
361448|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
361449|NCT00727194|E2|Reported Event|Eculizumab|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
361450|NCT00727194|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
361451|NCT00727090|B3|Baseline|Total|Total of all reporting groups
361452|NCT00727090|B2|Baseline|Usual Medical Care|Usual care by the attending physician staff
361453|NCT00727090|B1|Baseline|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361454|NCT00727090|P2|Participant Flow|Usual Medical Care|Usual care by the attending physician staff
361455|NCT00727090|P1|Participant Flow|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361456|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361457|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361458|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361459|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361460|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361461|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361462|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361463|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361464|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361465|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361466|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
361467|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361468|NCT00727090|E2|Reported Event|Usual Medical Care|Usual care by the attending physician staff
361469|NCT00727090|E1|Reported Event|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
361470|NCT00727064|B3|Baseline|Total|Total of all reporting groups
361471|NCT00727064|B2|Baseline|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
361472|NCT00727064|B1|Baseline|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
361473|NCT00727064|P2|Participant Flow|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
361474|NCT00727064|P1|Participant Flow|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
361475|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361476|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361477|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361478|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361479|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361480|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361481|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361482|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361483|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361484|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361485|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
361486|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
361487|NCT00727064|E2|Reported Event|Venlafaxine Extended Release (VEN ER)|SAE or AE reported on VEN ER regardless of which arm or period of trial.
361488|NCT00727064|E1|Reported Event|Desvenlafaxine Succinate Sustained-Release (DVS SR)|SAE or AE reported on DVS SR regardless of which arm or period of trial.
361489|NCT00727025|B1|Baseline|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
361490|NCT00727025|P1|Participant Flow|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
361491|NCT00727025|O2|Outcome|Suture Closure|
361500|NCT00726999|B2|Baseline|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361501|NCT00726999|B1|Baseline|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361502|NCT00726999|P2|Participant Flow|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361503|NCT00726999|P1|Participant Flow|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361504|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361505|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361506|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361507|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361508|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361509|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361510|NCT00726999|E2|Reported Event|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
361511|NCT00726999|E1|Reported Event|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
361512|NCT00726986|B1|Baseline|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361513|NCT00726986|P1|Participant Flow|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361514|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361515|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361516|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361517|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361518|NCT00726986|E1|Reported Event|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
361519|NCT00726895|B1|Baseline|Entire Study Population|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
361520|NCT00726895|P2|Participant Flow|Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361521|NCT00726895|P1|Participant Flow|Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361522|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361523|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
361524|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361525|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361526|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
361527|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361528|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361529|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
361530|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361531|NCT00726895|E2|Reported Event|Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361532|NCT00726895|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
361533|NCT00726882|B1|Baseline|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
361534|NCT00726882|P1|Participant Flow|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
361535|NCT00726882|O1|Outcome|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
361536|NCT00726882|O2|Outcome|Participants From Study M10-351|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00696904/M10-351) involving ABT−333.~Participants received no treatment in this follow-up study."
361537|NCT00726882|O1|Outcome|Participants From Study M10-380|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00851890/M10-380) involving ABT−333.~Participants received no treatment in this follow-up study."
361538|NCT00726882|E1|Reported Event|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
361539|NCT00726830|B3|Baseline|Total|Total of all reporting groups
361540|NCT00726830|B2|Baseline|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
361541|NCT00726830|B1|Baseline|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
361542|NCT00726830|P2|Participant Flow|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
361543|NCT00726830|P1|Participant Flow|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
361544|NCT00726830|O2|Outcome|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
361545|NCT00726830|O1|Outcome|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
361546|NCT00726830|E2|Reported Event|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
361547|NCT00726830|E1|Reported Event|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
361548|NCT00726752|B1|Baseline|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361549|NCT00726752|P1|Participant Flow|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361550|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361551|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361552|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361570|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
363690|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
361553|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361554|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361555|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361556|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361557|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361558|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361559|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361560|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361561|NCT00726752|E1|Reported Event|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
361562|NCT00726739|B3|Baseline|Total|Total of all reporting groups
361563|NCT00726739|B2|Baseline|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361564|NCT00726739|B1|Baseline|Arm I and III Crossover Group - LMI + Aldesleukin|"Includes 6 patients who progressed and crossed over from Arm II."
361565|NCT00726739|P2|Participant Flow|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361566|NCT00726739|P1|Participant Flow|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
361567|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361568|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II. Both KLH and DTH are tests assessing the ability to respond to immune therapy. These are independent tests and there is no bearing of KLH response on DTH response."
361569|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361571|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361572|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
361573|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361574|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
361575|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
361576|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
361577|NCT00726739|E2|Reported Event|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I.
361578|NCT00726739|E1|Reported Event|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
361579|NCT00726713|B3|Baseline|Total|Total of all reporting groups
361580|NCT00726713|B2|Baseline|Placebo|Placebo one tablet twice a day
361581|NCT00726713|B1|Baseline|Metanx|Metanx one tablet twice a day
361582|NCT00726713|P2|Participant Flow|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361583|NCT00726713|P1|Participant Flow|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361584|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
361585|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361586|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
361587|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361588|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361589|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361590|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
361591|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361592|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
361593|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361594|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361595|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361596|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361597|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361598|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361599|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361600|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361601|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361602|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361603|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361604|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
361605|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
361606|NCT00726713|E2|Reported Event|Placebo|Placebo one tablet twice a day
361607|NCT00726713|E1|Reported Event|Metanx|Metanx one tablet twice a day
361608|NCT00726661|B3|Baseline|Total|Total of all reporting groups
361609|NCT00726661|B2|Baseline|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361610|NCT00726661|B1|Baseline|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361611|NCT00726661|P2|Participant Flow|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361612|NCT00726661|P1|Participant Flow|Chemotherapy Cohort|Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361613|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361614|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361615|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361616|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361617|NCT00726661|O1|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361618|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361619|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361620|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361621|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361622|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361623|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361624|NCT00726661|E2|Reported Event|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361625|NCT00726661|E1|Reported Event|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
361626|NCT00726557|B1|Baseline|PegIntron + Rebetol|Baseline measures only available for the 118 participants who completed.
361627|NCT00726557|P1|Participant Flow|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
361628|NCT00726557|O1|Outcome|Participants Who Tolerated Treatment|Those who completed treatment.
361629|NCT00726557|O1|Outcome|Participants With Negative HCV-RNA at End of Treatment|End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
361630|NCT00726557|E1|Reported Event|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
361632|NCT00726453|B2|Baseline|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
361633|NCT00726453|B1|Baseline|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361634|NCT00726453|P2|Participant Flow|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
361635|NCT00726453|P1|Participant Flow|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361636|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361637|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361638|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361639|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361640|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361641|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
361642|NCT00726453|E2|Reported Event|38 mm Length Sub-Study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
361643|NCT00726453|E1|Reported Event|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG)."
361644|NCT00726414|B1|Baseline|Quinine Sulfate Under Fed and Fasted Conditions|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
361645|NCT00726414|P2|Participant Flow|Quinine Sulfate Under Fed Then Fasted Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
361646|NCT00726414|P1|Participant Flow|Quinine Sulfate Under Fasted Then Fed Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
361647|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
361648|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
369111|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
361649|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
361650|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361651|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
361652|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361653|NCT00726414|E2|Reported Event|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
361654|NCT00726414|E1|Reported Event|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
361655|NCT00726375|B1|Baseline|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
361656|NCT00726375|P1|Participant Flow|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
361657|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
361658|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
361659|NCT00726375|E1|Reported Event|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
361660|NCT00726232|B7|Baseline|Total|Total of all reporting groups
361661|NCT00726232|B6|Baseline|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361662|NCT00726232|B5|Baseline|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361663|NCT00726232|B4|Baseline|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361664|NCT00726232|B3|Baseline|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361665|NCT00726232|B2|Baseline|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361720|NCT00726063|B2|Baseline|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
361721|NCT00726063|B1|Baseline|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
361722|NCT00726063|P2|Participant Flow|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
361666|NCT00726232|B1|Baseline|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361667|NCT00726232|P6|Participant Flow|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361668|NCT00726232|P5|Participant Flow|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361669|NCT00726232|P4|Participant Flow|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361670|NCT00726232|P3|Participant Flow|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361671|NCT00726232|P2|Participant Flow|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361672|NCT00726232|P1|Participant Flow|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361673|NCT00726232|O6|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361674|NCT00726232|O5|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361675|NCT00726232|O4|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361676|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361677|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361678|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361723|NCT00726063|P1|Participant Flow|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
361724|NCT00726063|O2|Outcome|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
361725|NCT00726063|O1|Outcome|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
361679|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361680|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361681|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361682|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361683|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361684|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361685|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361686|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361687|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361688|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361689|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361690|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361691|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361692|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361693|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361694|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361695|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361696|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361697|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361698|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361699|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361700|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361701|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361702|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361703|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361704|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361705|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361706|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361707|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361708|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361709|NCT00726232|E6|Reported Event|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361710|NCT00726232|E5|Reported Event|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361711|NCT00726232|E4|Reported Event|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361712|NCT00726232|E3|Reported Event|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361713|NCT00726232|E2|Reported Event|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361714|NCT00726232|E1|Reported Event|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
361715|NCT00726180|B1|Baseline|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
361716|NCT00726180|P1|Participant Flow|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
361717|NCT00726180|O1|Outcome|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
361718|NCT00726180|E1|Reported Event|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
361719|NCT00726063|B3|Baseline|Total|Total of all reporting groups
361726|NCT00726063|E2|Reported Event|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
361727|NCT00726063|E1|Reported Event|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
361728|NCT00726037|B1|Baseline|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
361729|NCT00726037|P1|Participant Flow|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
361730|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
361731|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
361732|NCT00726037|E1|Reported Event|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
361733|NCT00725985|B4|Baseline|Total|Total of all reporting groups
361734|NCT00725985|B3|Baseline|Placebo|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
361735|NCT00725985|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
361736|NCT00725985|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
361737|NCT00725985|P12|Participant Flow|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361738|NCT00725985|P11|Participant Flow|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361739|NCT00725985|P10|Participant Flow|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361740|NCT00725985|P9|Participant Flow|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361741|NCT00725985|P8|Participant Flow|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361781|NCT00725920|E1|Reported Event|Topiramate|patients receiving the active drug: topiramate
363691|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
361742|NCT00725985|P7|Participant Flow|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361743|NCT00725985|P6|Participant Flow|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361744|NCT00725985|P5|Participant Flow|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361745|NCT00725985|P4|Participant Flow|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361746|NCT00725985|P3|Participant Flow|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361747|NCT00725985|P2|Participant Flow|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361748|NCT00725985|P1|Participant Flow|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
361749|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361750|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361751|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361752|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361753|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361754|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361755|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361756|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361757|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361758|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361759|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361760|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361761|NCT00725985|E12|Reported Event|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361762|NCT00725985|E11|Reported Event|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361763|NCT00725985|E10|Reported Event|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361764|NCT00725985|E9|Reported Event|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361765|NCT00725985|E8|Reported Event|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361766|NCT00725985|E7|Reported Event|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
361767|NCT00725985|E6|Reported Event|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361768|NCT00725985|E5|Reported Event|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361769|NCT00725985|E4|Reported Event|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
361770|NCT00725985|E3|Reported Event|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361771|NCT00725985|E2|Reported Event|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
361772|NCT00725985|E1|Reported Event|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
361773|NCT00725920|B3|Baseline|Total|Total of all reporting groups
361774|NCT00725920|B2|Baseline|Control Group|patients received pills content placebo, that were identical to the pills content active drug
361775|NCT00725920|B1|Baseline|Topiramate|patients receiving the active drug: topiramate
361776|NCT00725920|P2|Participant Flow|Control Group|patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
361777|NCT00725920|P1|Participant Flow|Topiramate|patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
361778|NCT00725920|O2|Outcome|Control Group|patients received pills content placebo, that were identical to the pills content active drug
361779|NCT00725920|O1|Outcome|Topiramate|patients receiving the active drug: topiramate
361780|NCT00725920|E2|Reported Event|Control Group|patients received pills content placebo, that were identical to the pills content active drug
361782|NCT00725842|B1|Baseline|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361783|NCT00725842|P1|Participant Flow|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361784|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361785|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361786|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361787|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361788|NCT00725842|E1|Reported Event|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
361789|NCT00724984|B7|Baseline|Total|Total of all reporting groups
361790|NCT00724984|B6|Baseline|Mantle Cell Lymphoma/Phase II|
361791|NCT00724984|B5|Baseline|Follicular/Phase II|
361792|NCT00724984|B4|Baseline|Cohort 4(60 mg/m2,7days/wk)/Phase 1|
361793|NCT00724984|B3|Baseline|Cohort 3(45 mg/m2, 7days/wk)/Phase 1|
361794|NCT00724984|B2|Baseline|Cohort 2(45 mg/m2, 5days/wk)/Phase 1|
361795|NCT00724984|B1|Baseline|Cohort 1(30 mg/m2, 5days/wk)/Phase 1|
361796|NCT00724984|P6|Participant Flow|Mantle Cell Lymphoma/Phase II|
361797|NCT00724984|P5|Participant Flow|Follicular/Phase II|
361798|NCT00724984|P4|Participant Flow|Cohort 4(60mg/m2,7days/wk)/Phase 1|
361799|NCT00724984|P3|Participant Flow|Cohort 3(45mg/m2,7days/wk)/Phase 1|
361800|NCT00724984|P2|Participant Flow|Cohort 2(45mg/m2,5days/wk)/Phase 1|
361801|NCT00724984|P1|Participant Flow|Cohort 1(30mg/m2,5days/wk)/Phase 1|
361802|NCT00724984|O2|Outcome|Mantle Cell Lymphoma/Phase II (Efficacy)|
361803|NCT00724984|O1|Outcome|Follicular/Phase II (Efficacy)|
361804|NCT00724984|O4|Outcome|Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I|
361805|NCT00724984|O3|Outcome|Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I|
361806|NCT00724984|O2|Outcome|Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I|
361807|NCT00724984|O1|Outcome|Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I|
361808|NCT00724984|E6|Reported Event|Mantle Cell Lymphoma/Phase II|
361809|NCT00724984|E5|Reported Event|Follicular/Phase II|
361810|NCT00724984|E4|Reported Event|Cohort 4(60 mg/m2,7days/wk)/Phase I|
361811|NCT00724984|E3|Reported Event|Cohort 3(45 mg/m2, 7days/wk)/Phase I|
361812|NCT00724984|E2|Reported Event|Cohort 2(45 mg/m2, 5days/wk)/Phase I|
361813|NCT00724984|E1|Reported Event|Cohort 1(30 mg/m2, 5days/wk)/Phase I|
361814|NCT00724958|B1|Baseline|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
361815|NCT00724958|P1|Participant Flow|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361816|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361817|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361818|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361819|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361820|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361821|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361822|NCT00724958|E1|Reported Event|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
361823|NCT00724945|B1|Baseline|Overall|The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
361824|NCT00724945|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
361825|NCT00724945|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
361826|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
361827|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
361828|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
361829|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
361830|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
361831|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
361832|NCT00724945|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
363692|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
361833|NCT00724945|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
361834|NCT00724932|B3|Baseline|Total|Total of all reporting groups
361835|NCT00724932|B2|Baseline|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361836|NCT00724932|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361837|NCT00724932|P2|Participant Flow|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
361838|NCT00724932|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)
361839|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361840|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361841|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361842|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361843|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361844|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361845|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361846|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361847|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361848|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361849|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361850|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361851|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361852|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361853|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361854|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361855|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361856|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361857|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361858|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361859|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361860|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361861|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361862|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361863|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361864|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361865|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361866|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361867|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361868|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361869|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361870|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361871|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361872|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361873|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361874|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361875|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361876|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361877|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361878|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361879|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361880|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361881|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
363693|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
361882|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361883|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361884|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361885|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361886|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361887|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361888|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361889|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361890|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361891|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361892|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361893|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361894|NCT00724932|O1|Outcome|Neostigmine Only|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361895|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361896|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361897|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361898|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361899|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361900|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361901|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361902|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
361903|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361904|NCT00724932|E2|Reported Event|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
361905|NCT00724932|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
361906|NCT00725751|B3|Baseline|Total|Total of all reporting groups
361907|NCT00725751|B2|Baseline|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361908|NCT00725751|B1|Baseline|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361909|NCT00725751|P2|Participant Flow|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361910|NCT00725751|P1|Participant Flow|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361911|NCT00725751|O1|Outcome|All Participants|"Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)~Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)"
361912|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361913|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361914|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361915|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361916|NCT00725751|E2|Reported Event|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361917|NCT00725751|E1|Reported Event|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
361918|NCT00725725|B4|Baseline|Total|Total of all reporting groups
361919|NCT00725725|B3|Baseline|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361920|NCT00725725|B2|Baseline|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361921|NCT00725725|B1|Baseline|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
363694|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
361922|NCT00725725|P3|Participant Flow|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361923|NCT00725725|P2|Participant Flow|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361924|NCT00725725|P1|Participant Flow|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361925|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361926|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361927|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361928|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361929|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361930|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361931|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361932|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361933|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361934|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361935|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361936|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361937|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361938|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361939|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361940|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361941|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361942|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361943|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361944|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361945|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361946|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361947|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361948|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361949|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361950|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361951|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361952|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361953|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361954|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361955|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361956|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361957|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361958|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361959|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361960|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361961|NCT00725725|E3|Reported Event|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
361962|NCT00725725|E2|Reported Event|Org 25935 12 mg|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
361963|NCT00725725|E1|Reported Event|Org 25935 4 mg|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
361978|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361964|NCT00725621|B1|Baseline|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361965|NCT00725621|P1|Participant Flow|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361966|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361967|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361968|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361969|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361970|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361971|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361972|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361973|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361974|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361975|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361976|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361977|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
362026|NCT00725452|E1|Reported Event|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
363695|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
361979|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361980|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361981|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361982|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361983|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361984|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361985|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361986|NCT00725621|E1|Reported Event|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
361987|NCT00725608|B1|Baseline|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361988|NCT00725608|P1|Participant Flow|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361989|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361990|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361991|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361992|NCT00725608|E1|Reported Event|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
361993|NCT00725543|B1|Baseline|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361994|NCT00725543|P1|Participant Flow|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361995|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361996|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
362091|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
361997|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361998|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
361999|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
362000|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
362001|NCT00725543|E1|Reported Event|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
362002|NCT00725530|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
362003|NCT00725530|P2|Participant Flow|Etafilcon A / Balafilcon A|Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
362004|NCT00725530|P1|Participant Flow|Balafilcon A / Etafilcon A|Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
362005|NCT00725530|O2|Outcome|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
362006|NCT00725530|O1|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
362007|NCT00725530|E2|Reported Event|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
362008|NCT00725530|E1|Reported Event|Balafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
362009|NCT00725491|B3|Baseline|Total|Total of all reporting groups
362010|NCT00725491|B2|Baseline|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
362011|NCT00725491|B1|Baseline|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
362012|NCT00725491|P2|Participant Flow|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
362013|NCT00725491|P1|Participant Flow|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
362014|NCT00725491|O2|Outcome|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
362015|NCT00725491|O1|Outcome|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
362016|NCT00725491|E2|Reported Event|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
362017|NCT00725491|E1|Reported Event|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
362018|NCT00725452|B1|Baseline|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362019|NCT00725452|P1|Participant Flow|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362020|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362021|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362022|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362023|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362024|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362025|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
362502|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
362027|NCT00725296|B1|Baseline|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362028|NCT00725296|P1|Participant Flow|Infliximab|Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362029|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362030|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362031|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362032|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362033|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362034|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362035|NCT00725296|E1|Reported Event|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
362036|NCT00725205|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362503|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
362037|NCT00725205|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362038|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362039|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362040|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362041|NCT00725205|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
362042|NCT00725153|B1|Baseline|Overall|All enrolled participants
362043|NCT00725153|P2|Participant Flow|Acuvue 2 / PureVision|Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
362044|NCT00725153|P1|Participant Flow|PureVision / Acuvue 2|PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
362045|NCT00725153|O2|Outcome|Acuvue 2 Contact Lenses|Acuvue 2 lenses worn 10 hours
362046|NCT00725153|O1|Outcome|PureVision Contact Lenses|PureVision lenses worn 10 hours
362047|NCT00725153|E2|Reported Event|Acuvue 2 Lenses Worn 10 Hours|Acuvue 2 lenses worn 10 hours
362048|NCT00725153|E1|Reported Event|PureVision Lenses Worn 10 Hours|PureVision lenses worn 10 hours
362049|NCT00725101|B1|Baseline|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362050|NCT00725101|P1|Participant Flow|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362051|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362052|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362053|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362054|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362055|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362056|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362057|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362058|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362059|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362060|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362061|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362062|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362063|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362064|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362065|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362066|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362067|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362068|NCT00725101|E1|Reported Event|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
362069|NCT00725075|B4|Baseline|Total|Total of all reporting groups
362070|NCT00725075|B3|Baseline|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362071|NCT00725075|B2|Baseline|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362155|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362504|NCT00723931|E1|Reported Event|Pegintron/Pegintron Redipen Injection|
362072|NCT00725075|B1|Baseline|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362073|NCT00725075|P3|Participant Flow|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362074|NCT00725075|P2|Participant Flow|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362075|NCT00725075|P1|Participant Flow|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362076|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362077|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362078|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362079|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362080|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362081|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362082|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362083|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362084|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362085|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362086|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362087|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362088|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362089|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362090|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362505|NCT00723892|B3|Baseline|Total|Total of all reporting groups
362092|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362093|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362094|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362095|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362096|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362097|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362098|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362099|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362100|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362101|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362102|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362103|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362104|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362105|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362106|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362107|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362108|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362109|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362110|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
363091|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
362111|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362112|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362113|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362114|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362115|NCT00725075|E3|Reported Event|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
362116|NCT00725075|E2|Reported Event|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362117|NCT00725075|E1|Reported Event|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
362118|NCT00725049|B3|Baseline|Total|Total of all reporting groups
362119|NCT00725049|B2|Baseline|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
362120|NCT00725049|B1|Baseline|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
362121|NCT00725049|P2|Participant Flow|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
362122|NCT00725049|P1|Participant Flow|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
362123|NCT00725049|O2|Outcome|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
362124|NCT00725049|O1|Outcome|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
362125|NCT00725049|E2|Reported Event|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
362126|NCT00725049|E1|Reported Event|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
362127|NCT00725010|B1|Baseline|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
362128|NCT00725010|P1|Participant Flow|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
362129|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
362130|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
362131|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
362156|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362157|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362132|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
362133|NCT00725010|E2|Reported Event|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
362134|NCT00725010|E1|Reported Event|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
362135|NCT00724893|B3|Baseline|Total|Total of all reporting groups
362136|NCT00724893|B2|Baseline|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362137|NCT00724893|B1|Baseline|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362138|NCT00724893|P2|Participant Flow|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362139|NCT00724893|P1|Participant Flow|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362140|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362141|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362142|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362143|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362144|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362145|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362146|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362147|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362148|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362149|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362150|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362151|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362152|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362153|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362154|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362506|NCT00723892|B2|Baseline|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362158|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362159|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362160|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362161|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362162|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362163|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362164|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362165|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362166|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362167|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362168|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362169|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362170|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362171|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362172|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362173|NCT00724893|O5|Outcome|>85 kg|Participants with weight >85 kg
362174|NCT00724893|O4|Outcome|75 to <85 kg|Participants with weight 75 to <85 kg
362175|NCT00724893|O3|Outcome|64 to <75 kg|Participants with weight 64 to <75 kg
362176|NCT00724893|O2|Outcome|50 to <64 kg|Participants with weight 50 to <64 kg
362177|NCT00724893|O1|Outcome|40 to <50 kg|Participants with weight 40 to <50 kg
362178|NCT00724893|O3|Outcome|Viral Load Missing|Participants with viral load missing
362179|NCT00724893|O2|Outcome|Viral Load Low|Participants with viral load xxxx
362180|NCT00724893|O1|Outcome|Viral Load High|Participants with viral load xxxx
362181|NCT00724893|O6|Outcome|Unknown Stage|Participants with unknown Fibrosis Stage
362182|NCT00724893|O5|Outcome|Stage F4|Participants with Fibrosis Stage F4
362183|NCT00724893|O4|Outcome|Stage F3|Participants with Fibrosis Stage F4
362184|NCT00724893|O3|Outcome|Stage F2|Participants with Fibrosis Stage F2
362185|NCT00724893|O2|Outcome|Stage F1|Participants with Fibrosis Stage F1
362186|NCT00724893|O1|Outcome|Stage F0|Participants with Fibrosis Stage F0
362187|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362188|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362189|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362190|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362191|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362192|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362507|NCT00723892|B1|Baseline|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362193|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362194|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362195|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362196|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362197|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362198|NCT00724893|O2|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362199|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362200|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362201|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362202|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362203|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362204|NCT00724893|E2|Reported Event|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362205|NCT00724893|E1|Reported Event|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
362206|NCT00724867|B1|Baseline|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362207|NCT00724867|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362208|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362209|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362210|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362211|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362265|NCT00724815|P2|Participant Flow|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362212|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362213|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362214|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362215|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362216|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362217|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362218|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362219|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362220|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362221|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362222|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362223|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362224|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362225|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362226|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362227|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362228|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362229|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362230|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362231|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362232|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362233|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362234|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362235|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362236|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362237|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362238|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362239|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362240|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362241|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
362242|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
362243|NCT00724867|E1|Reported Event|Belimumab 10 mg/kg IV|Belimumab 10 mg/kg IV every 28 days
362244|NCT00724854|B3|Baseline|Total|Total of all reporting groups
362245|NCT00724854|B2|Baseline|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362246|NCT00724854|B1|Baseline|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362247|NCT00724854|P2|Participant Flow|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362248|NCT00724854|P1|Participant Flow|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362249|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362250|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362251|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362252|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362253|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362254|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362255|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362256|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362257|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362258|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362259|NCT00724854|E3|Reported Event|Not Evaluated|
362260|NCT00724854|E2|Reported Event|Co-Infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362261|NCT00724854|E1|Reported Event|Mono-Infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
362262|NCT00724815|B3|Baseline|Total|Total of all reporting groups
362263|NCT00724815|B2|Baseline|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362264|NCT00724815|B1|Baseline|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
369112|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
362266|NCT00724815|P1|Participant Flow|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362267|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362268|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362269|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362270|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362271|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362272|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362273|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362274|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362275|NCT00724815|E2|Reported Event|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362276|NCT00724815|E1|Reported Event|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
362277|NCT00724750|B3|Baseline|Total|Total of all reporting groups
362278|NCT00724750|B2|Baseline|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362279|NCT00724750|B1|Baseline|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362280|NCT00724750|P2|Participant Flow|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362281|NCT00724750|P1|Participant Flow|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362282|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362283|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362284|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362285|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362286|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362287|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362288|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362289|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362290|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362291|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362292|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362293|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362322|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362294|NCT00724750|E2|Reported Event|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
362295|NCT00724750|E1|Reported Event|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
362296|NCT00724711|B3|Baseline|Total|Total of all reporting groups
362297|NCT00724711|B2|Baseline|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362298|NCT00724711|B1|Baseline|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362299|NCT00724711|P2|Participant Flow|Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362300|NCT00724711|P1|Participant Flow|FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362301|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362302|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362303|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362304|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362305|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362306|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362307|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362308|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362309|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362310|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362311|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362312|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362313|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362314|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362315|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362316|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362317|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362318|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362319|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362320|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362321|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362508|NCT00723892|P2|Participant Flow|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362323|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362324|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362325|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362326|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362327|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362328|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362329|NCT00724711|E2|Reported Event|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
362330|NCT00724711|E1|Reported Event|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
362331|NCT00724698|B1|Baseline|Desloratadine|Desloratadine 5 mg daily
362332|NCT00724698|P1|Participant Flow|Desloratadine|Desloratadine 5 mg daily
362333|NCT00724698|O1|Outcome|Desloratadine|Desloratadine 5 mg daily
362334|NCT00724594|B5|Baseline|Total|Total of all reporting groups
362335|NCT00724594|B4|Baseline|Control Maternal|Mothers of infants treated with saline
362336|NCT00724594|B3|Baseline|NAC Maternal|Mothers of infants treated with N-acetylcysteine
362337|NCT00724594|B2|Baseline|Control Infant|Infants treated with saline
362338|NCT00724594|B1|Baseline|NAC Infant|Infants treated with N-acetylcysteine
362339|NCT00724594|P4|Participant Flow|Control Maternal|Mothers of infants treated with saline
362340|NCT00724594|P3|Participant Flow|NAC Maternal|Mothers of infants treated with N-acetylcysteine
362341|NCT00724594|P2|Participant Flow|Control Infant|Infants treated with saline
362342|NCT00724594|P1|Participant Flow|NAC Infant|Infants treated with N-acetylcysteine
362343|NCT00724594|O4|Outcome|Control Maternal|Mothers treated with saline prior to delivery
362344|NCT00724594|O3|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
362345|NCT00724594|O2|Outcome|Control Infants|Infants treated with saline
362346|NCT00724594|O1|Outcome|NAC Infants|Infants treated with N-acetylcysteine
362347|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to birth
362348|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
362349|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
362350|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
362351|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
362352|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
362353|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
362354|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
362355|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
362356|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
362357|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
362358|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
362359|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
362360|NCT00724594|E4|Reported Event|Control Maternal|Mothers of infants treated with saline
362361|NCT00724594|E3|Reported Event|NAC Maternal|Mothers of infants treated with N-acetylcysteine
362362|NCT00724594|E2|Reported Event|Control Infant|Infants treated with saline
362363|NCT00724594|E1|Reported Event|NAC Infant|Infants treated with N-acetylcysteine
362364|NCT00724568|B1|Baseline|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
362365|NCT00724568|P2|Participant Flow|Phase II|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
362366|NCT00724568|P1|Participant Flow|Phase I|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
362367|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
362368|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
363092|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
362369|NCT00724568|E1|Reported Event|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
362370|NCT00724477|B1|Baseline|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
362371|NCT00724477|P1|Participant Flow|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
362372|NCT00724477|O1|Outcome|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
362373|NCT00724477|E1|Reported Event|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
362374|NCT00724464|B1|Baseline|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362375|NCT00724464|P1|Participant Flow|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362376|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
362377|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362378|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362379|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362380|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362381|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362382|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362383|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362509|NCT00723892|P1|Participant Flow|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362384|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
362385|NCT00724464|E1|Reported Event|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
362386|NCT00724451|B1|Baseline|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
362387|NCT00724451|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
362388|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
362389|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
362390|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
362391|NCT00724451|E1|Reported Event|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
362392|NCT00724373|B1|Baseline|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
362393|NCT00724373|P1|Participant Flow|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
362394|NCT00724373|O1|Outcome|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
362395|NCT00724373|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
362396|NCT00724347|B1|Baseline|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
362397|NCT00724347|P1|Participant Flow|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
362398|NCT00724347|O1|Outcome|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
362399|NCT00724347|E1|Reported Event|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
362400|NCT00724308|B3|Baseline|Total|Total of all reporting groups
362401|NCT00724308|B2|Baseline|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
362402|NCT00724308|B1|Baseline|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
362403|NCT00724308|P2|Participant Flow|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
362404|NCT00724308|P1|Participant Flow|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
362405|NCT00724308|O2|Outcome|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
362406|NCT00724308|O1|Outcome|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
362407|NCT00724308|E2|Reported Event|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
362408|NCT00724308|E1|Reported Event|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
362409|NCT00724282|B1|Baseline|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
362410|NCT00724282|P1|Participant Flow|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
362411|NCT00724282|O1|Outcome|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
362412|NCT00724282|E1|Reported Event|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
362413|NCT00724243|B1|Baseline|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
362414|NCT00724243|P1|Participant Flow|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
362415|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
362416|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
362417|NCT00724243|E1|Reported Event|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
362418|NCT00724152|B6|Baseline|Total|Total of all reporting groups
362419|NCT00724152|B5|Baseline|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
362420|NCT00724152|B4|Baseline|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
362421|NCT00724152|B3|Baseline|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize.
362422|NCT00724152|B2|Baseline|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
362423|NCT00724152|B1|Baseline|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize.
362424|NCT00724152|P3|Participant Flow|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
362425|NCT00724152|P2|Participant Flow|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources."
362426|NCT00724152|P1|Participant Flow|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
362427|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
363696|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
362428|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
362429|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
362430|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
362431|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
362432|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
362433|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
362434|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
362435|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
362436|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
362437|NCT00724152|E3|Reported Event|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
362438|NCT00724152|E2|Reported Event|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment."
362475|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
363093|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
362439|NCT00724152|E1|Reported Event|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
362440|NCT00724126|B3|Baseline|Total|Total of all reporting groups
362441|NCT00724126|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362442|NCT00724126|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362443|NCT00724126|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362444|NCT00724126|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362445|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362446|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362447|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362448|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362449|NCT00724126|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362450|NCT00724126|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
362451|NCT00724061|B1|Baseline|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
362452|NCT00724061|P1|Participant Flow|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
362453|NCT00724061|O1|Outcome|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
362454|NCT00724061|E1|Reported Event|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
362455|NCT00724009|B1|Baseline|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362456|NCT00724009|P1|Participant Flow|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362457|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362458|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362459|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
363697|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
362460|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362461|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362462|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362463|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362464|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362465|NCT00724009|E1|Reported Event|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
362466|NCT00723957|B3|Baseline|Total|Total of all reporting groups
362467|NCT00723957|B2|Baseline|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362468|NCT00723957|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362469|NCT00723957|P2|Participant Flow|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362470|NCT00723957|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362471|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362472|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362473|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362474|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
363698|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
362476|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362477|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362478|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362479|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362480|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362481|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362482|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362483|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362484|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362485|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362486|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362487|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362488|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362489|NCT00723957|E2|Reported Event|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
362490|NCT00723957|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
362491|NCT00723944|B3|Baseline|Total|Total of all reporting groups
362492|NCT00723944|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
362493|NCT00723944|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
362494|NCT00723944|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
362495|NCT00723944|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
362496|NCT00723944|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
362497|NCT00723944|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
362498|NCT00723944|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
362499|NCT00723944|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
362500|NCT00723931|B1|Baseline|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
362501|NCT00723931|P1|Participant Flow|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
369113|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
362510|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362511|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362512|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362513|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
362514|NCT00723892|E1|Reported Event|All Enrolled Participants|
362515|NCT00723840|B1|Baseline|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
362516|NCT00723840|P1|Participant Flow|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
362517|NCT00723840|O4|Outcome|18 Months|QoL scores per participant at 18 months
362518|NCT00723840|O3|Outcome|12 Months|QoL scores per participant at 12 months
362519|NCT00723840|O2|Outcome|6 Months|QoL scores per participant at 6 months
362520|NCT00723840|O1|Outcome|Baseline|QoL scores per participant at baseline
362521|NCT00723840|O4|Outcome|18 Months|Costs per participant at 18 months in Euros
362522|NCT00723840|O3|Outcome|12 Months|Costs per participant at 12 months in Euros
362523|NCT00723840|O2|Outcome|6 Months|Costs per participant at 6 months in Euros
362524|NCT00723840|O1|Outcome|Baseline|Costs per participant at baseline in Euros
362525|NCT00723840|E1|Reported Event|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
362526|NCT00723827|B1|Baseline|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362527|NCT00723827|P1|Participant Flow|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362528|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362529|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362530|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362531|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362532|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362533|NCT00723827|E1|Reported Event|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
362534|NCT00722800|B3|Baseline|Total|Total of all reporting groups
362535|NCT00722800|B2|Baseline|Placebo Tablets|Placebo tablet once a day for 6 months
362536|NCT00722800|B1|Baseline|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362537|NCT00722800|P2|Participant Flow|Placebo Tablets|Placebo tablet once a day for 6 months
363699|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
362538|NCT00722800|P1|Participant Flow|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362539|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
362540|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362541|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
362542|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362543|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
362544|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362545|NCT00722800|E2|Reported Event|Placebo Tablets|Placebo tablet once a day for 6 months
362546|NCT00722800|E1|Reported Event|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
362547|NCT00722761|B3|Baseline|Total|Total of all reporting groups
362548|NCT00722761|B2|Baseline|Placebo Tablet|Placebo tablet once a day
362549|NCT00722761|B1|Baseline|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
362550|NCT00722761|P2|Participant Flow|Placebo Tablet|Placebo tablet once a day
362551|NCT00722761|P1|Participant Flow|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
362552|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
362553|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
362554|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
362555|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
362556|NCT00722761|E2|Reported Event|Placebo Tablet|Placebo tablet once a day
362557|NCT00722761|E1|Reported Event|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
362558|NCT00722722|B4|Baseline|Total|Total of all reporting groups
362559|NCT00722722|B3|Baseline|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362560|NCT00722722|B2|Baseline|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362561|NCT00722722|B1|Baseline|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362562|NCT00722722|P3|Participant Flow|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362563|NCT00722722|P2|Participant Flow|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362564|NCT00722722|P1|Participant Flow|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362565|NCT00722722|O3|Outcome|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362566|NCT00722722|O2|Outcome|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362567|NCT00722722|O1|Outcome|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362568|NCT00722722|E3|Reported Event|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362569|NCT00722722|E2|Reported Event|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362570|NCT00722722|E1|Reported Event|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
362571|NCT00723801|B3|Baseline|Total|Total of all reporting groups
362572|NCT00723801|B2|Baseline|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
362573|NCT00723801|B1|Baseline|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
362574|NCT00723801|P2|Participant Flow|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
362575|NCT00723801|P1|Participant Flow|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
362576|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
362577|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
362578|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
362579|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
362580|NCT00723801|E2|Reported Event|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
362581|NCT00723801|E1|Reported Event|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
362582|NCT00723788|B1|Baseline|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
362583|NCT00723788|P1|Participant Flow|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
362584|NCT00723788|O3|Outcome|CT of the Abdomen|All patients enrolled received an MRI followed in some cases by computed tomography.
362585|NCT00723788|O2|Outcome|US of the Abdomen|All patients enrolled received an MRI followed in some cases by ultrasund.
362586|NCT00723788|O1|Outcome|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
362587|NCT00723788|E1|Reported Event|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
362588|NCT00723749|B1|Baseline|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
369114|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
362589|NCT00723749|P1|Participant Flow|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362590|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362591|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362592|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362593|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362594|NCT00723749|E1|Reported Event|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
362595|NCT00723736|B1|Baseline|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
362596|NCT00723736|P1|Participant Flow|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
362597|NCT00723736|O1|Outcome|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
362598|NCT00723736|E1|Reported Event|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
362599|NCT00723710|B1|Baseline|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
362600|NCT00723710|P1|Participant Flow|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
362601|NCT00723710|O1|Outcome|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
362602|NCT00723710|E1|Reported Event|Intron-A|
362603|NCT00723697|B1|Baseline|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362604|NCT00723697|P1|Participant Flow|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362605|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362606|NCT00723697|O3|Outcome|Patients at 12 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362607|NCT00723697|O2|Outcome|Patients at 6 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362608|NCT00723697|O1|Outcome|Patients at First Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362609|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
362610|NCT00723697|E1|Reported Event|Patients|
362611|NCT00723645|B1|Baseline|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
362612|NCT00723645|P1|Participant Flow|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
362613|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
362614|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
362615|NCT00723645|E1|Reported Event|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
362616|NCT00723632|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362617|NCT00723632|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362618|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362619|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362620|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362621|NCT00723632|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
362622|NCT00723606|B3|Baseline|Total|Total of all reporting groups
362623|NCT00723606|B2|Baseline|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362624|NCT00723606|B1|Baseline|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362625|NCT00723606|P2|Participant Flow|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362626|NCT00723606|P1|Participant Flow|Ziprasidone|An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment.
362627|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362628|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362629|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362630|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362631|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362632|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362633|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362634|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362635|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362636|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362637|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
362638|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362639|NCT00723606|E2|Reported Event|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
363094|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
362640|NCT00723606|E1|Reported Event|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
362641|NCT00723580|B1|Baseline|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
362642|NCT00723580|P1|Participant Flow|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
362643|NCT00723580|O1|Outcome|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
362644|NCT00723580|E1|Reported Event|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
362645|NCT00723554|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362646|NCT00723554|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362647|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362648|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362649|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362650|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362651|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362652|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362653|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362654|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362655|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362656|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362657|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362658|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362659|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362660|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362661|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362662|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362663|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362664|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362665|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362666|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362667|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362668|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362669|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362670|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362671|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362672|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362673|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362674|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362675|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362676|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362677|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362678|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362679|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362680|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362681|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362682|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362683|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362684|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
362685|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362686|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362687|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
362688|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362689|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362690|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362691|NCT00723554|E1|Reported Event|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
362692|NCT00723528|B4|Baseline|Total|Total of all reporting groups
362693|NCT00723528|B3|Baseline|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362694|NCT00723528|B2|Baseline|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362695|NCT00723528|B1|Baseline|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362696|NCT00723528|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
362697|NCT00723528|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
362850|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
362698|NCT00723528|P5|Participant Flow|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362699|NCT00723528|P4|Participant Flow|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362700|NCT00723528|P3|Participant Flow|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362701|NCT00723528|P2|Participant Flow|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362702|NCT00723528|P1|Participant Flow|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362703|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362704|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362705|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362706|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362707|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362708|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362709|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362710|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362711|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362712|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362713|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362714|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362715|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362716|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362717|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362718|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362719|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362720|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362721|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362722|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362723|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362724|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362725|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362726|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362727|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362728|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362729|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362730|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362731|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362732|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362733|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362734|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362735|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362736|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362737|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362738|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362739|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362740|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362741|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362742|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362823|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362743|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362744|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362745|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362746|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362747|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362748|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362749|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362750|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362751|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362752|NCT00723528|E7|Reported Event|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
362753|NCT00723528|E6|Reported Event|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
362754|NCT00723528|E5|Reported Event|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
362755|NCT00723528|E4|Reported Event|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
362756|NCT00723528|E3|Reported Event|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362757|NCT00723528|E2|Reported Event|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
362758|NCT00723528|E1|Reported Event|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
362759|NCT00723489|B5|Baseline|Total|Total of all reporting groups
362760|NCT00723489|B4|Baseline|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362761|NCT00723489|B3|Baseline|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362762|NCT00723489|B2|Baseline|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362763|NCT00723489|B1|Baseline|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362764|NCT00723489|P4|Participant Flow|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362765|NCT00723489|P3|Participant Flow|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362766|NCT00723489|P2|Participant Flow|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362767|NCT00723489|P1|Participant Flow|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
363095|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
362768|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362769|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362770|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362771|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362772|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362773|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362774|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362775|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362776|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362777|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362778|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362779|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362780|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362781|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362782|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362783|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362784|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362785|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362786|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362825|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362787|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362788|NCT00723489|E4|Reported Event|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362789|NCT00723489|E3|Reported Event|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
362790|NCT00723489|E2|Reported Event|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
362791|NCT00723489|E1|Reported Event|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
362792|NCT00723450|B3|Baseline|Total|Total of all reporting groups
362793|NCT00723450|B2|Baseline|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362794|NCT00723450|B1|Baseline|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362795|NCT00723450|P3|Participant Flow|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362796|NCT00723450|P2|Participant Flow|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362797|NCT00723450|P1|Participant Flow|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362798|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362799|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362800|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362801|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362802|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362803|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362804|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362805|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362824|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
369115|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
362806|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362807|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362808|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362809|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362810|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362811|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362812|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362813|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362814|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362815|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362816|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362817|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362818|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362819|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362820|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362821|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
362822|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
363700|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
362826|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362827|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362828|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362829|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362830|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362831|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362832|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362833|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
362834|NCT00723450|E3|Reported Event|Randomized and Double-blind Taper Phases: LTG|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
362835|NCT00723450|E2|Reported Event|Randomized and Double-blind Taper Phases: Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase.
362836|NCT00723450|E1|Reported Event|Open-Label and Open-Label Taper Phases: LTG|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
362837|NCT00723255|B1|Baseline|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362838|NCT00723255|P1|Participant Flow|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362839|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
362840|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
362841|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
362842|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
362843|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
362844|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
362845|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
362846|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
362847|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
362848|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
362849|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
363701|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
362851|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362852|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362853|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362854|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362855|NCT00723255|E1|Reported Event|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
362856|NCT00723203|B1|Baseline|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
362857|NCT00723203|P1|Participant Flow|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
362858|NCT00723203|O1|Outcome|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
362859|NCT00723203|E1|Reported Event|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
362860|NCT00723190|B1|Baseline|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362861|NCT00723190|P1|Participant Flow|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362862|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362863|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362864|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362865|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362866|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362867|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362868|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362869|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362870|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362871|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362872|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362873|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362874|NCT00723190|E1|Reported Event|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
362875|NCT00723177|B4|Baseline|Total|Total of all reporting groups
369116|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
362876|NCT00723177|B3|Baseline|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362877|NCT00723177|B2|Baseline|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362878|NCT00723177|B1|Baseline|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362879|NCT00723177|P3|Participant Flow|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
362880|NCT00723177|P2|Participant Flow|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
362881|NCT00723177|P1|Participant Flow|Placebo|"This group received placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
362882|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362883|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362884|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362885|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362886|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362887|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362888|NCT00723177|E3|Reported Event|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362889|NCT00723177|E2|Reported Event|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362890|NCT00723177|E1|Reported Event|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
362891|NCT00723125|B3|Baseline|Total|Total of all reporting groups
362892|NCT00723125|B2|Baseline|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362893|NCT00723125|B1|Baseline|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362894|NCT00723125|P2|Participant Flow|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362895|NCT00723125|P1|Participant Flow|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362896|NCT00723125|O2|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362926|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362927|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
363702|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
362897|NCT00723125|O1|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
362898|NCT00723125|E6|Reported Event|Cohort 2 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
362899|NCT00723125|E5|Reported Event|Cohort 1 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
362900|NCT00723125|E4|Reported Event|Cohort 2 DDAC|Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
362901|NCT00723125|E3|Reported Event|Cohort 1 DDAC|Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
362902|NCT00723125|E2|Reported Event|Cohort 2 Neo-adjuvant|Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
362903|NCT00723125|E1|Reported Event|Cohort 1 Neo-adjuvant|Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10
362904|NCT00723073|B3|Baseline|Total|Total of all reporting groups
362905|NCT00723073|B2|Baseline|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362906|NCT00723073|B1|Baseline|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362907|NCT00723073|P2|Participant Flow|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362908|NCT00723073|P1|Participant Flow|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362909|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362910|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362911|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362912|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362913|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362914|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362915|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362916|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362917|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362918|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362919|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362920|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362921|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362922|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362923|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362924|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362925|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
363096|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
362928|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362929|NCT00723073|E2|Reported Event|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
362930|NCT00723073|E1|Reported Event|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
362931|NCT00723021|B1|Baseline|All Participants|Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
362932|NCT00723021|P5|Participant Flow|Treatment Sequence 5|Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
362933|NCT00723021|P4|Participant Flow|Treatment Sequence 4|PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
362934|NCT00723021|P3|Participant Flow|Treatment Sequence 3|PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
362935|NCT00723021|P2|Participant Flow|Treatment Sequence 2|PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
362936|NCT00723021|P1|Participant Flow|Treatment Sequence 1|Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
362937|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362938|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362939|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362940|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362941|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362942|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362943|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362944|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362945|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362946|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362947|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362948|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362949|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362950|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362951|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362952|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
362953|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362954|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362955|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362956|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
362957|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
362958|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362959|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
362960|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
362961|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
362962|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
362963|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362964|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362965|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362966|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
362967|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
362968|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362969|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
362970|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
362971|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
362972|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
362973|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362974|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362975|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362976|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
362977|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
362978|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362979|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362980|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362981|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
362982|NCT00723021|E5|Reported Event|Zileuton CR 1200 mg|Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
362983|NCT00723021|E4|Reported Event|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
362984|NCT00723021|E3|Reported Event|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
362985|NCT00723021|E2|Reported Event|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
362986|NCT00723021|E1|Reported Event|Placebo|Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
362987|NCT00723008|B3|Baseline|Total|Total of all reporting groups
362988|NCT00723008|B2|Baseline|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362989|NCT00723008|B1|Baseline|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362990|NCT00723008|P2|Participant Flow|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362991|NCT00723008|P1|Participant Flow|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362992|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362993|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
362994|NCT00723008|O4|Outcome|Group B: AFTER Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
362995|NCT00723008|O3|Outcome|Group B: BEFORE Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
362996|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
362997|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
362998|NCT00723008|O4|Outcome|Group B: AFTER Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
362999|NCT00723008|O3|Outcome|Group B: BEFORE Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
363000|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
363001|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
363002|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363003|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363004|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363005|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363006|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363007|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
363008|NCT00723008|E4|Reported Event|Group B: Unblinded Phase|Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks.
363009|NCT00723008|E3|Reported Event|Group B: Blinded Phase|Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
363010|NCT00723008|E2|Reported Event|Group A: Unblinded Phase|Subjects using Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6).
363011|NCT00723008|E1|Reported Event|Group A: Blinded Phase|Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
363012|NCT00722566|B3|Baseline|Total|Total of all reporting groups
363013|NCT00722566|B2|Baseline|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363014|NCT00722566|B1|Baseline|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363015|NCT00722566|P2|Participant Flow|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363016|NCT00722566|P1|Participant Flow|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363017|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363018|NCT00722566|O1|Outcome|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363019|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363020|NCT00722566|O1|Outcome|VELCADE Subcutaneuous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363021|NCT00722566|E2|Reported Event|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363022|NCT00722566|E1|Reported Event|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
363051|NCT00722423|O2|Outcome|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
363703|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363023|NCT00722553|B1|Baseline|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
363024|NCT00722553|P1|Participant Flow|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
363025|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
363026|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
363027|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
363028|NCT00722553|O1|Outcome|Evaluable Patients|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
363029|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
363030|NCT00722553|E1|Reported Event|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
363031|NCT00722436|B3|Baseline|Total|Total of all reporting groups
363032|NCT00722436|B2|Baseline|Placebo|"Saline~saline: Placebo"
363033|NCT00722436|B1|Baseline|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363034|NCT00722436|P2|Participant Flow|Placebo|"Saline~saline: Placebo"
363035|NCT00722436|P1|Participant Flow|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363036|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
363037|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363038|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
363039|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363040|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
363041|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363042|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
363043|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363044|NCT00722436|E2|Reported Event|Placebo|"Saline~saline: Placebo"
363045|NCT00722436|E1|Reported Event|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
363046|NCT00722423|B3|Baseline|Total|Total of all reporting groups
363047|NCT00722423|B2|Baseline|Usucal Care Model|
363048|NCT00722423|B1|Baseline|Integrated Care Model|Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
363049|NCT00722423|P2|Participant Flow|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
363050|NCT00722423|P1|Participant Flow|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
363704|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363052|NCT00722423|O1|Outcome|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
363053|NCT00722423|O2|Outcome|Usual Care Model|"usual care~Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider."
363054|NCT00722423|O1|Outcome|Integrated Care Model|"integrated care~Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals."
363055|NCT00722423|E2|Reported Event|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
363056|NCT00722423|E1|Reported Event|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
363057|NCT00722371|B8|Baseline|Total|Total of all reporting groups
363058|NCT00722371|B7|Baseline|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363059|NCT00722371|B6|Baseline|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363060|NCT00722371|B5|Baseline|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363061|NCT00722371|B4|Baseline|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363062|NCT00722371|B3|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363063|NCT00722371|B2|Baseline|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363064|NCT00722371|B1|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363065|NCT00722371|P7|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363066|NCT00722371|P6|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363067|NCT00722371|P5|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363068|NCT00722371|P4|Participant Flow|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363069|NCT00722371|P3|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363070|NCT00722371|P2|Participant Flow|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363071|NCT00722371|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363072|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363073|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363074|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363075|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363076|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363077|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363078|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363079|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363080|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363081|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363082|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363083|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363084|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363085|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363086|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363087|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363088|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363089|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363090|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363097|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363098|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363099|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363100|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363101|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363102|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363103|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363104|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363105|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363106|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363107|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363108|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363109|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363110|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363111|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363112|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363113|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363114|NCT00722371|E7|Reported Event|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
363115|NCT00722371|E6|Reported Event|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
363116|NCT00722371|E5|Reported Event|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
363117|NCT00722371|E4|Reported Event|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
363118|NCT00722371|E3|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
363119|NCT00722371|E2|Reported Event|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
363120|NCT00722371|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
363121|NCT00722137|B3|Baseline|Total|Total of all reporting groups
363122|NCT00722137|B2|Baseline|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363123|NCT00722137|B1|Baseline|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363124|NCT00722137|P2|Participant Flow|R-CHOP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles"
363125|NCT00722137|P1|Participant Flow|VcR-CAP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363126|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363127|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363128|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363705|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363129|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363130|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363131|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363132|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363133|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363134|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363135|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363136|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363137|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363138|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363139|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363140|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363141|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363142|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363143|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363170|NCT00722020|O2|Outcome|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
363706|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363144|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363145|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363146|NCT00722137|E2|Reported Event|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
363147|NCT00722137|E1|Reported Event|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
363148|NCT00722124|B4|Baseline|Total|Total of all reporting groups
363149|NCT00722124|B3|Baseline|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
363150|NCT00722124|B2|Baseline|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
363151|NCT00722124|B1|Baseline|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
363152|NCT00722124|P3|Participant Flow|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
363153|NCT00722124|P2|Participant Flow|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
363154|NCT00722124|P1|Participant Flow|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
363155|NCT00722124|O3|Outcome|Placebo|
363156|NCT00722124|O2|Outcome|SAMe 1600|
363157|NCT00722124|O1|Outcome|SAMe 800|
363158|NCT00722124|E3|Reported Event|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
363159|NCT00722124|E2|Reported Event|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
363160|NCT00722124|E1|Reported Event|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
363161|NCT00722072|B1|Baseline|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
363162|NCT00722072|P1|Participant Flow|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
363163|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
363164|NCT00722072|E1|Reported Event|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
363165|NCT00722020|B3|Baseline|Total|Total of all reporting groups
363166|NCT00722020|B2|Baseline|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
363167|NCT00722020|B1|Baseline|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
363168|NCT00722020|P2|Participant Flow|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
363169|NCT00722020|P1|Participant Flow|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
363476|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363171|NCT00722020|O1|Outcome|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
363172|NCT00722020|O2|Outcome|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
363173|NCT00722020|O1|Outcome|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
363174|NCT00722020|E2|Reported Event|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
363175|NCT00722020|E1|Reported Event|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
363176|NCT00721968|B3|Baseline|Total|Total of all reporting groups
363177|NCT00721968|B2|Baseline|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
363178|NCT00721968|B1|Baseline|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
363179|NCT00721968|P2|Participant Flow|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
363180|NCT00721968|P1|Participant Flow|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
363181|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
363182|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
363183|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
363184|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
363185|NCT00721968|E2|Reported Event|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
363186|NCT00721968|E1|Reported Event|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
363187|NCT00721734|B6|Baseline|Total|Total of all reporting groups
363188|NCT00721734|B5|Baseline|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363189|NCT00721734|B4|Baseline|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363190|NCT00721734|B3|Baseline|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363191|NCT00721734|B2|Baseline|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363192|NCT00721734|B1|Baseline|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363193|NCT00721734|P5|Participant Flow|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363194|NCT00721734|P4|Participant Flow|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363195|NCT00721734|P3|Participant Flow|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363503|NCT00721396|B3|Baseline|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363196|NCT00721734|P2|Participant Flow|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363197|NCT00721734|P1|Participant Flow|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363198|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363199|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363200|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363201|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363202|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363203|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363204|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363205|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363206|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363207|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363208|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363209|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363210|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363504|NCT00721396|B2|Baseline|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363211|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363212|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363213|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363214|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363215|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363216|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363217|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363218|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363219|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363220|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363221|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363222|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363223|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363224|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363225|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363505|NCT00721396|B1|Baseline|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363226|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363227|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363228|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363229|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363230|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363231|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363232|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363233|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363234|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363235|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363236|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363237|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363238|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363239|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363240|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363506|NCT00721396|P4|Participant Flow|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
369117|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
363241|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363242|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363243|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363244|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363245|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363246|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363247|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363248|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363249|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363250|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363251|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363252|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363253|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363254|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363255|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363507|NCT00721396|P3|Participant Flow|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363256|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363257|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363258|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363259|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363260|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363261|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363262|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363263|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363264|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363265|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363266|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363267|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363268|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363269|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363270|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363508|NCT00721396|P2|Participant Flow|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363271|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363272|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363273|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363274|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363275|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363276|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363277|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363278|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363279|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363280|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363281|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363282|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363283|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363284|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363285|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363509|NCT00721396|P1|Participant Flow|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363286|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363287|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363288|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363289|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363290|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363291|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363292|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363293|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363294|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363295|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363296|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363297|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363298|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363299|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363300|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363510|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
369118|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
363301|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363302|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363303|NCT00721734|E5|Reported Event|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363304|NCT00721734|E4|Reported Event|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363305|NCT00721734|E3|Reported Event|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363306|NCT00721734|E2|Reported Event|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363307|NCT00721734|E1|Reported Event|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
363308|NCT00721617|B1|Baseline|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.
363309|NCT00721617|P1|Participant Flow|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363310|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363311|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363312|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363313|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363314|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363315|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363316|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363317|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363318|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363319|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363320|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363321|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363322|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363323|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363324|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363325|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363326|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363327|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363328|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363329|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363330|NCT00721617|O1|Outcome|Healthy Subjects|Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
363331|NCT00721617|E1|Reported Event|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
363332|NCT00721578|B1|Baseline|Entire Study Population|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363333|NCT00721578|P2|Participant Flow|Other Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
363334|NCT00721578|P1|Participant Flow|Voriconazole Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
363335|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363336|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infection|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363337|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363338|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363339|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363340|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363341|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363342|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363343|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363344|NCT00721578|E1|Reported Event|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
363675|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363345|NCT00721539|B1|Baseline|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363346|NCT00721539|P1|Participant Flow|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363347|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363348|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363349|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363350|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363351|NCT00721539|E1|Reported Event|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
363352|NCT00721500|B1|Baseline|All Subjects|All subjects who enrolled and completed study.
363353|NCT00721500|P4|Participant Flow|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
363354|NCT00721500|P3|Participant Flow|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
363355|NCT00721500|P2|Participant Flow|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
363356|NCT00721500|P1|Participant Flow|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
363357|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
363358|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
363359|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
363360|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|Narafilcon A contact lens worn in both eyes.
363361|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
363362|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
363363|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
363364|NCT00721500|O1|Outcome|Narafilcon A|Narafilcon A contact lens worn in both eyes.
363365|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
363366|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
363367|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
363368|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|narafilcon A contact lens worn in both eyes.
363676|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363369|NCT00721500|E4|Reported Event|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
363370|NCT00721500|E3|Reported Event|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
363371|NCT00721500|E2|Reported Event|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
363372|NCT00721500|E1|Reported Event|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
363373|NCT00721409|B4|Baseline|Total|Total of all reporting groups
363374|NCT00721409|B3|Baseline|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363375|NCT00721409|B2|Baseline|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363376|NCT00721409|B1|Baseline|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363377|NCT00721409|P3|Participant Flow|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363378|NCT00721409|P2|Participant Flow|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363379|NCT00721409|P1|Participant Flow|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363380|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363381|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363382|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363383|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363384|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363385|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363386|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363387|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363388|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363389|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363390|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363391|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363392|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363393|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363394|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363395|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363396|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363397|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363398|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363399|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363400|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363401|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363402|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363403|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363404|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363405|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363406|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363407|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363408|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363409|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363410|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363411|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363412|NCT00721409|O4|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363413|NCT00721409|O3|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363414|NCT00721409|O2|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363415|NCT00721409|O1|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363416|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363417|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363418|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363419|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363420|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363677|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363421|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363422|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363423|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363424|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363425|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363426|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363427|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363428|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363429|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363430|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363431|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363432|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363433|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363434|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363435|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363436|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363437|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363438|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363439|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363440|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363441|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363442|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363443|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363444|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363445|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363446|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363678|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363447|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363448|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363449|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363450|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363451|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363452|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363453|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363454|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363455|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363456|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363457|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363458|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363459|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363460|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363461|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363462|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363463|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363464|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363465|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
363466|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
363467|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
363468|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
363469|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
363470|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
363471|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363472|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363473|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363474|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363475|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363679|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363477|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363478|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363479|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363480|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363481|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363482|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
363483|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363484|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363485|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363486|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363487|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363488|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363489|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363490|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363491|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363492|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363493|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363494|NCT00721409|E7|Reported Event|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363495|NCT00721409|E6|Reported Event|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363496|NCT00721409|E5|Reported Event|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
363497|NCT00721409|E4|Reported Event|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363498|NCT00721409|E3|Reported Event|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
363499|NCT00721409|E2|Reported Event|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
363500|NCT00721409|E1|Reported Event|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
363501|NCT00721396|B5|Baseline|Total|Total of all reporting groups
363502|NCT00721396|B4|Baseline|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363680|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363511|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363512|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363513|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363514|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363515|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363516|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363517|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363518|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363519|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363520|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363521|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363522|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363523|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363524|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363525|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363526|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363527|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363528|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363529|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363530|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363531|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363532|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363533|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
363534|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
363535|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
363536|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363537|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363538|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363539|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363540|NCT00721396|E4|Reported Event|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
363541|NCT00721396|E3|Reported Event|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
363542|NCT00721396|E2|Reported Event|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
363543|NCT00721396|E1|Reported Event|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
363544|NCT00721357|B3|Baseline|Total|Total of all reporting groups
363545|NCT00721357|B2|Baseline|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363546|NCT00721357|B1|Baseline|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363547|NCT00721357|P2|Participant Flow|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363548|NCT00721357|P1|Participant Flow|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363549|NCT00721357|O2|Outcome|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363550|NCT00721357|O1|Outcome|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363551|NCT00721357|E2|Reported Event|Group 2|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363552|NCT00721357|E1|Reported Event|Group 1|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
363553|NCT00721279|B3|Baseline|Total|Total of all reporting groups
363554|NCT00721279|B2|Baseline|Pre-treated Patients|Patients that had been treated for RLS at baseline
363555|NCT00721279|B1|Baseline|De-novo Patients|Patients that had not been treated for RLS at baseline
363556|NCT00721279|P2|Participant Flow|Pre-treated Patients|Patients that had been treated for RLS at baseline
363557|NCT00721279|P1|Participant Flow|De-novo Patients|Patients that had not been treated for RLS at baseline
363558|NCT00721279|O1|Outcome|Overall|All Patients
363559|NCT00721279|O1|Outcome|Overall|All Patients
363560|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
363561|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
363562|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
363563|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
363564|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
363565|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
363566|NCT00721279|E2|Reported Event|Pre-treated Patients|Patients that had been treated for RLS at baseline
363567|NCT00721279|E1|Reported Event|De-novo Patients|Patients that had not been treated for RLS at baseline
363568|NCT00721253|B3|Baseline|Total|Total of all reporting groups
363569|NCT00721253|B2|Baseline|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363570|NCT00721253|B1|Baseline|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363571|NCT00721253|P3|Participant Flow|Tecnis MF|Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
363572|NCT00721253|P2|Participant Flow|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363573|NCT00721253|P1|Participant Flow|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363574|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363575|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363576|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363577|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363578|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363579|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363580|NCT00721253|E2|Reported Event|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
363581|NCT00721253|E1|Reported Event|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
363582|NCT00721227|B3|Baseline|Total|Total of all reporting groups
363583|NCT00721227|B2|Baseline|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363584|NCT00721227|B1|Baseline|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363585|NCT00721227|P2|Participant Flow|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363586|NCT00721227|P1|Participant Flow|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363587|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363588|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363589|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363590|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363591|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363592|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363593|NCT00721227|E2|Reported Event|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
363594|NCT00721227|E1|Reported Event|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
363595|NCT00721214|B1|Baseline|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363596|NCT00721214|P1|Participant Flow|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363597|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363598|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363599|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363600|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363601|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363602|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363603|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363604|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363605|NCT00721214|E1|Reported Event|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
363606|NCT00721188|B1|Baseline|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363607|NCT00721188|P1|Participant Flow|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363608|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363609|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363610|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363611|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363612|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363613|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363614|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363615|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363616|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363617|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363618|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363619|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363620|NCT00721188|E1|Reported Event|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
363621|NCT00721175|B3|Baseline|Total|Total of all reporting groups
363622|NCT00721175|B2|Baseline|Plastic Stent|plastic stent group
363623|NCT00721175|B1|Baseline|SEMS|self-expandable metal stent group
363624|NCT00721175|P2|Participant Flow|Plastic Stent|plastic stent group
363625|NCT00721175|P1|Participant Flow|SEMS|self-expandable metal stent group
363626|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
363627|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
363628|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
363629|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
363630|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
363631|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
363632|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
363633|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
363634|NCT00721175|E2|Reported Event|Plastic Stent|plastic stent group
363635|NCT00721175|E1|Reported Event|SEMS|self-expandable metal stent group
363636|NCT00721162|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363681|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363637|NCT00721162|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363638|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363639|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363640|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363641|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363642|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363643|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363644|NCT00721162|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
363645|NCT00721149|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363646|NCT00721149|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363647|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363648|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363649|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363650|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363651|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363652|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363653|NCT00721149|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
363654|NCT00721123|B1|Baseline|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
363655|NCT00721123|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
363656|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363657|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363658|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363659|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363660|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363661|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363662|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363663|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363664|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363665|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363666|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363667|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363668|NCT00721123|O1|Outcome|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
363669|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).
363670|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192 (Total PY=388.25).
363671|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).
363672|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96 (Total PY=444.49).
363673|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).
363674|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363707|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363708|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363709|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363710|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363711|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363712|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363713|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363714|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363715|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363716|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
363717|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
363718|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
363719|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
363720|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
363721|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
363722|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264.
363723|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192.
363724|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
363725|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96.
363726|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48.
363727|NCT00721123|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
363728|NCT00720941|B3|Baseline|Total|Total of all reporting groups
363729|NCT00720941|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363730|NCT00720941|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363731|NCT00720941|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363732|NCT00720941|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363733|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363734|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363735|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363736|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363737|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363738|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363739|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363740|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363741|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363814|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
364929|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
363742|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363743|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363744|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363745|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363746|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363747|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363748|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363749|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363750|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363751|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363752|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363753|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363754|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363755|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363756|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363757|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363758|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363759|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363760|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363761|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363762|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363763|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363764|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363765|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363766|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363767|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363768|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363769|NCT00720941|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363770|NCT00720941|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
363771|NCT00720798|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363772|NCT00720798|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363773|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363774|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363775|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363776|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363777|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363778|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363779|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363780|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363781|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363782|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363783|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363784|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363785|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363786|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363787|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363788|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363789|NCT00720798|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
363790|NCT00720759|B5|Baseline|Total|Total of all reporting groups
363791|NCT00720759|B4|Baseline|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
363792|NCT00720759|B3|Baseline|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
363793|NCT00720759|B2|Baseline|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363794|NCT00720759|B1|Baseline|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363795|NCT00720759|P4|Participant Flow|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
363796|NCT00720759|P3|Participant Flow|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
363797|NCT00720759|P2|Participant Flow|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363798|NCT00720759|P1|Participant Flow|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363799|NCT00720759|O4|Outcome|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
363800|NCT00720759|O3|Outcome|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
363801|NCT00720759|O2|Outcome|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363802|NCT00720759|O1|Outcome|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363803|NCT00720759|E4|Reported Event|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
363804|NCT00720759|E3|Reported Event|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
363805|NCT00720759|E2|Reported Event|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363806|NCT00720759|E1|Reported Event|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
363807|NCT00720629|B1|Baseline|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363808|NCT00720629|P1|Participant Flow|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363809|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363810|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363811|NCT00720629|O2|Outcome|5 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
363812|NCT00720629|O1|Outcome|2 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
363813|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363815|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363816|NCT00720629|E1|Reported Event|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
363817|NCT00720499|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way cross-over study. The two treatment periods were separated by a wash-out period of 14 days during which they received open-label Tiotropium 5 mcg. The 2 treatments, administered once daily in the morning via the respimat inhaler, were :~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
363818|NCT00720499|P2|Participant Flow|Tio+Olo5/5µg / Tio+Olo5/2µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
363819|NCT00720499|P1|Participant Flow|Tio+Olo 5/2µg / Tio+Olo5/5µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
363820|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363821|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363822|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363823|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363824|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363825|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363826|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363827|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363828|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363829|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363830|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363831|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363832|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363833|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363834|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363835|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363836|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363837|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363838|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363839|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363966|NCT00720278|B2|Baseline|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
369119|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
363840|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363841|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363842|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363843|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363844|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363845|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363846|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363847|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363848|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363849|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363850|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363851|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363852|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363853|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363854|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363855|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363856|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363857|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363858|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363859|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363860|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363861|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363862|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363863|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363864|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363865|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363866|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363867|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363868|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363869|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363870|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363871|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363872|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363873|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363874|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363875|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363876|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363877|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363878|NCT00720499|E2|Reported Event|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363879|NCT00720499|E1|Reported Event|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
363880|NCT00720473|B3|Baseline|Total|Total of all reporting groups
363881|NCT00720473|B2|Baseline|Control Subjects|Age matched controls without BPD
363882|NCT00720473|B1|Baseline|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363883|NCT00720473|P2|Participant Flow|B: Healthy Control|No Intervention
363884|NCT00720473|P1|Participant Flow|A: BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363885|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363886|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363887|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363888|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363889|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363890|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363891|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363892|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363893|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363894|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363895|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363896|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363897|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363898|NCT00720473|O1|Outcome|A: Other|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363899|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363900|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363901|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363902|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363903|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
363904|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
363905|NCT00720473|E2|Reported Event|BPD Subjects|
363906|NCT00720473|E1|Reported Event|Control Subjects|Age matched controls without BPD
363907|NCT00720434|B5|Baseline|Total|Total of all reporting groups
363908|NCT00720434|B4|Baseline|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363909|NCT00720434|B3|Baseline|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363910|NCT00720434|B2|Baseline|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363911|NCT00720434|B1|Baseline|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
363912|NCT00720434|P4|Participant Flow|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363913|NCT00720434|P3|Participant Flow|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363914|NCT00720434|P2|Participant Flow|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363915|NCT00720434|P1|Participant Flow|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
363916|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363917|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363918|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363919|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
369120|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
363920|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363921|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363922|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363923|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
363924|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363925|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363926|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363927|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
363928|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363929|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363930|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363931|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
364003|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
363932|NCT00720434|E4|Reported Event|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363933|NCT00720434|E3|Reported Event|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363934|NCT00720434|E2|Reported Event|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
363935|NCT00720434|E1|Reported Event|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
363936|NCT00720382|B3|Baseline|Total|Total of all reporting groups
363937|NCT00720382|B2|Baseline|Nasonex®|Mometasone furoate 200 mcg
363938|NCT00720382|B1|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
363939|NCT00720382|P2|Participant Flow|Nasonex®|Mometasone furoate 200 mcg
363940|NCT00720382|P1|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
363941|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
363942|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
363943|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
363944|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
363945|NCT00720382|E2|Reported Event|Nasonex®|Mometasone furoate 200 mcg
363946|NCT00720382|E1|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
363947|NCT00720369|B3|Baseline|Total|Total of all reporting groups
363948|NCT00720369|B2|Baseline|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363949|NCT00720369|B1|Baseline|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363950|NCT00720369|P2|Participant Flow|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363951|NCT00720369|P1|Participant Flow|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363952|NCT00720369|O2|Outcome|Healthy Controls|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
363953|NCT00720369|O1|Outcome|CoQ10|Open Label Study
363954|NCT00720369|O2|Outcome|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
363955|NCT00720369|O1|Outcome|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
363956|NCT00720369|E2|Reported Event|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363957|NCT00720369|E1|Reported Event|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
363958|NCT00720343|B1|Baseline|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
363959|NCT00720343|P1|Participant Flow|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
363960|NCT00720343|O2|Outcome|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
363961|NCT00720343|O1|Outcome|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
363962|NCT00720343|E2|Reported Event|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
363963|NCT00720343|E1|Reported Event|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
363964|NCT00720278|B4|Baseline|Total|Total of all reporting groups
363965|NCT00720278|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
364004|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
363967|NCT00720278|B1|Baseline|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363968|NCT00720278|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363969|NCT00720278|P2|Participant Flow|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363970|NCT00720278|P1|Participant Flow|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363971|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363972|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363973|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363974|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363975|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363976|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363977|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363978|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363979|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363980|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363981|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363982|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363983|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363984|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363985|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363986|NCT00720278|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363987|NCT00720278|E2|Reported Event|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363988|NCT00720278|E1|Reported Event|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
363989|NCT00720122|B1|Baseline|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
363990|NCT00720122|P1|Participant Flow|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
363991|NCT00720122|O1|Outcome|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
363992|NCT00720122|E1|Reported Event|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
363993|NCT00720109|B1|Baseline|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
363994|NCT00720109|P3|Participant Flow|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
363995|NCT00720109|P2|Participant Flow|Standard-risk|Based on Minimal Residual Disease, less than 1%.
363996|NCT00720109|P1|Participant Flow|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
363997|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
363998|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
363999|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
364000|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
364001|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
364002|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
364005|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
364006|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
364007|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
364008|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
364009|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
364010|NCT00720109|E3|Reported Event|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
364011|NCT00720109|E2|Reported Event|Standard-risk|Based on Minimal Residual Disease, less than 1%.
364012|NCT00720109|E1|Reported Event|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
364013|NCT00720096|B3|Baseline|Total|Total of all reporting groups
364014|NCT00720096|B2|Baseline|Topotecan|Topotecan - Chemotherapy single agent systemic.
364015|NCT00720096|B1|Baseline|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
364016|NCT00720096|P2|Participant Flow|Topotecan|Topotecan - Chemotherapy single agent systemic.
364017|NCT00720096|P1|Participant Flow|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
364018|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
364019|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
364020|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
364021|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
364022|NCT00720096|E2|Reported Event|Topotecan|Topotecan - Chemotherapy single agent systemic.
364023|NCT00720096|E1|Reported Event|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
364024|NCT00720083|B3|Baseline|Total|Total of all reporting groups
364025|NCT00720083|B2|Baseline|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364026|NCT00720083|B1|Baseline|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364027|NCT00720083|P2|Participant Flow|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364028|NCT00720083|P1|Participant Flow|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364029|NCT00720083|O2|Outcome|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364030|NCT00720083|O1|Outcome|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364031|NCT00720083|E2|Reported Event|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364032|NCT00720083|E1|Reported Event|RT+ Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
364033|NCT00720057|B3|Baseline|Total|Total of all reporting groups
364034|NCT00720057|B2|Baseline|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364035|NCT00720057|B1|Baseline|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364036|NCT00720057|P2|Participant Flow|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364037|NCT00720057|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364038|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364039|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364040|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364041|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364042|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364043|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364044|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364045|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364046|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364047|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364048|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364049|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364050|NCT00720057|E2|Reported Event|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364051|NCT00720057|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
364052|NCT00719953|B1|Baseline|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
364053|NCT00719953|P1|Participant Flow|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
364054|NCT00719953|O1|Outcome|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
364055|NCT00719953|E1|Reported Event|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
364056|NCT00719914|B3|Baseline|Total|Total of all reporting groups
364057|NCT00719914|B2|Baseline|Bolus of Normal Saline|Intra-coronary injection of normal saline.
364058|NCT00719914|B1|Baseline|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
364059|NCT00719914|P2|Participant Flow|Bolus of Normal Saline|Intracoronary injection of normal saline.
364060|NCT00719914|P1|Participant Flow|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
364061|NCT00719914|O2|Outcome|Bolus of Normal Saline|Intra-coronary injection of normal saline.
364062|NCT00719914|O1|Outcome|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
364063|NCT00719914|E2|Reported Event|Bolus of Normal Saline|Intra-coronary injection of normal saline.
364064|NCT00719914|E1|Reported Event|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
364065|NCT00719901|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364066|NCT00719901|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364067|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364068|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364069|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364070|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364071|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364128|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364072|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364073|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364074|NCT00719901|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
364075|NCT00719862|B3|Baseline|Total|Total of all reporting groups
364076|NCT00719862|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364077|NCT00719862|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364078|NCT00719862|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364079|NCT00719862|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364080|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364081|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364082|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364083|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364084|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364085|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364086|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364087|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364088|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364089|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364090|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364091|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364092|NCT00719862|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
364093|NCT00719862|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
364094|NCT00719810|B4|Baseline|Total|Total of all reporting groups
364095|NCT00719810|B3|Baseline|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
364096|NCT00719810|B2|Baseline|Delafloxacin 450 mg IV q12h|
364097|NCT00719810|B1|Baseline|Delafloxacin 300 mg IV q12h|
364098|NCT00719810|P3|Participant Flow|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
364099|NCT00719810|P2|Participant Flow|Delafloxacin 450 mg IV q12h|
364100|NCT00719810|P1|Participant Flow|Delafloxacin 300 mg IV q12h|
364101|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
364102|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
364103|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
364104|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
364105|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
364106|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
364107|NCT00719810|E3|Reported Event|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
364108|NCT00719810|E2|Reported Event|Delafloxacin 450 mg IV q12h|
364109|NCT00719810|E1|Reported Event|Delafloxacin 300 mg IV q12h|
364110|NCT00719732|B1|Baseline|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
364111|NCT00719732|P1|Participant Flow|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
364112|NCT00719732|O1|Outcome|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
364113|NCT00719732|E1|Reported Event|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
364114|NCT00719706|B3|Baseline|Total|Total of all reporting groups
364115|NCT00719706|B2|Baseline|Placebo|Participants taking placebo.
364116|NCT00719706|B1|Baseline|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364117|NCT00719706|P2|Participant Flow|Placebo|Participants taking placebo.
364118|NCT00719706|P1|Participant Flow|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364119|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
364120|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364121|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
364122|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364123|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
364124|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364125|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
364126|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364127|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
364130|NCT00719706|E1|Reported Event|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
364131|NCT00719680|B1|Baseline|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
364132|NCT00719680|P1|Participant Flow|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
364133|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364134|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364135|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364136|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364137|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364138|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364139|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364140|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364141|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364142|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364143|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364144|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364145|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364146|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364147|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364148|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364149|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
364150|NCT00719680|E1|Reported Event|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
364151|NCT00719615|B4|Baseline|Total|Total of all reporting groups
364152|NCT00719615|B3|Baseline|Active Thyroid Cancer|
364153|NCT00719615|B2|Baseline|Thyroid Cancer in Remission|
364154|NCT00719615|B1|Baseline|Thyroid Nodules|
364155|NCT00719615|P3|Participant Flow|Active Thyroid Cancer|
364156|NCT00719615|P2|Participant Flow|Thyroid Cancer in Remission|
364157|NCT00719615|P1|Participant Flow|Thyroid Nodules|
364158|NCT00719615|O3|Outcome|Active Thyroid Cancer|
364159|NCT00719615|O2|Outcome|Thyroid Cancer in Remission|
364160|NCT00719615|O1|Outcome|Thyroid Nodules|
364161|NCT00719615|E3|Reported Event|Active Thyroid Cancer|
364162|NCT00719615|E2|Reported Event|Thyroid Cancer in Remission|
364163|NCT00719615|E1|Reported Event|Thyroid Nodules|
364164|NCT00719563|B3|Baseline|Total|Total of all reporting groups
364165|NCT00719563|B2|Baseline|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364166|NCT00719563|B1|Baseline|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364167|NCT00719563|P2|Participant Flow|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364168|NCT00719563|P1|Participant Flow|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364927|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364169|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364170|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364171|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364172|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364173|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364174|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364175|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364176|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364177|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364178|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364179|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364180|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364181|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364182|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364183|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364184|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364185|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364186|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364187|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364188|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364189|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364190|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364191|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
364192|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364193|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364194|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364195|NCT00719563|E2|Reported Event|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364196|NCT00719563|E1|Reported Event|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
364197|NCT00719472|B1|Baseline|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364198|NCT00719472|P1|Participant Flow|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364199|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364200|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364270|NCT00719186|B1|Baseline|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364201|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364202|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364203|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364204|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364205|NCT00719472|E1|Reported Event|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
364206|NCT00719355|B3|Baseline|Total|Total of all reporting groups
364207|NCT00719355|B2|Baseline|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
364208|NCT00719355|B1|Baseline|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
364209|NCT00719355|P2|Participant Flow|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
364210|NCT00719355|P1|Participant Flow|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
364211|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
364212|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
364213|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
364214|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
364215|NCT00719355|E2|Reported Event|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
364216|NCT00719355|E1|Reported Event|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
364217|NCT00719329|B4|Baseline|Total|Total of all reporting groups
364218|NCT00719329|B3|Baseline|Dry Cord Care|Dry cord care, as recommended by WHO
364219|NCT00719329|B2|Baseline|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
364220|NCT00719329|B1|Baseline|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
364221|NCT00719329|P3|Participant Flow|Dry Cord Care|Dry cord care, as recommended by WHO
364222|NCT00719329|P2|Participant Flow|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
364223|NCT00719329|P1|Participant Flow|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
364224|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
364225|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
364226|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
364227|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
364228|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
364229|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
364230|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
364231|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
364232|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
364233|NCT00719329|E3|Reported Event|Dry Cord Care|Dry cord care, as recommended by WHO
364234|NCT00719329|E2|Reported Event|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
364235|NCT00719329|E1|Reported Event|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
364236|NCT00719264|B3|Baseline|Total|Total of all reporting groups
364237|NCT00719264|B2|Baseline|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364238|NCT00719264|B1|Baseline|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364239|NCT00719264|P2|Participant Flow|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364240|NCT00719264|P1|Participant Flow|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364241|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364271|NCT00719186|P2|Participant Flow|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364242|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364243|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364244|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364245|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364246|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364247|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364248|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364249|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364250|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364251|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364252|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364253|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364254|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364255|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364256|NCT00719264|E2|Reported Event|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
364257|NCT00719264|E1|Reported Event|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
364258|NCT00719212|B1|Baseline|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364259|NCT00719212|P1|Participant Flow|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364260|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364261|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364262|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364263|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364264|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364265|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364266|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364267|NCT00719212|E1|Reported Event|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364268|NCT00719186|B3|Baseline|Total|Total of all reporting groups
364269|NCT00719186|B2|Baseline|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364785|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364272|NCT00719186|P1|Participant Flow|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364273|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364274|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364275|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364276|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364277|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364278|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364279|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364280|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364281|NCT00719186|E2|Reported Event|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364282|NCT00719186|E1|Reported Event|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
364283|NCT00719160|B1|Baseline|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
364284|NCT00719160|P2|Participant Flow|Intervention Placebo First/Esomeprazole Second|In this group this group received the placebo first and then the intervention
364285|NCT00719160|P1|Participant Flow|Intervention Esomeprazole First/Placebo Second|In this group this group received the intervention first and then the placebo
364286|NCT00719160|O2|Outcome|Placebo|Placebo 20 mg twice a day given as either the first or second intervention.
364287|NCT00719160|O1|Outcome|Esomeprazole Study Drug|Esomeprazole 20 mg twice daily given as either the first or second intervention
364288|NCT00719160|O2|Outcome|Placebo|Placebo administered twice daily in either first or second intervention
364289|NCT00719160|O1|Outcome|Esomeprazole|Esomeprazoled administered twice daily in either first or second intervention period
364290|NCT00719160|E1|Reported Event|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
364291|NCT00719134|B1|Baseline|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
364292|NCT00719134|P1|Participant Flow|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
364293|NCT00719134|O1|Outcome|All Participants|
364294|NCT00719134|O1|Outcome|All Participants|
364295|NCT00719134|E2|Reported Event|Placebo|
364296|NCT00719134|E1|Reported Event|Maxalt|
364297|NCT00719043|B8|Baseline|Total|Total of all reporting groups
364298|NCT00719043|B7|Baseline|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364299|NCT00719043|B6|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364300|NCT00719043|B5|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364447|NCT00718887|O2|Outcome|Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364930|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364301|NCT00719043|B4|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364302|NCT00719043|B3|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364303|NCT00719043|B2|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364304|NCT00719043|B1|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364305|NCT00719043|P7|Participant Flow|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364306|NCT00719043|P6|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364307|NCT00719043|P5|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364308|NCT00719043|P4|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364309|NCT00719043|P3|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364310|NCT00719043|P2|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364311|NCT00719043|P1|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364312|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364313|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364314|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364315|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364316|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364317|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364318|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364319|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364320|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364321|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364322|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364323|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364336|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364324|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364325|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364326|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364327|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364328|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364329|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364330|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364331|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364332|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364333|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364334|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364335|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364444|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364445|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364337|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364338|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364339|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364340|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364341|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364342|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364343|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364344|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364345|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364346|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364347|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364348|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364349|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364350|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364351|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364352|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364353|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364354|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364355|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364356|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364357|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364358|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364359|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364360|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364361|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364362|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364363|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364364|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364365|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364366|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364367|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364368|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364369|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364370|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364371|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364372|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364373|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364374|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364375|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364376|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364377|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364378|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364379|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364380|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364381|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364382|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364383|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364384|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364385|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364386|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364387|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364388|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364389|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364390|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364391|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364392|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364393|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364394|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364395|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364396|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364397|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364398|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364399|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364400|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364619|NCT00718042|B7|Baseline|Total|Total of all reporting groups
364401|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364402|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364403|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364404|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364405|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364406|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364407|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364408|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364409|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364410|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364411|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364412|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364413|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364414|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364415|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364416|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364417|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364418|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364419|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364420|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364421|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364422|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364423|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364424|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364446|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364425|NCT00719043|E7|Reported Event|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
364426|NCT00719043|E6|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364427|NCT00719043|E5|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364428|NCT00719043|E4|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364429|NCT00719043|E3|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364430|NCT00719043|E2|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364431|NCT00719043|E1|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
364432|NCT00718887|B3|Baseline|Total|Total of all reporting groups
364433|NCT00718887|B2|Baseline|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364434|NCT00718887|B1|Baseline|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364435|NCT00718887|P2|Participant Flow|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364436|NCT00718887|P1|Participant Flow|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364437|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364438|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364439|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364440|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364441|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364442|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364443|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364448|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364449|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364450|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364451|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364452|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364453|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364454|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD) for a maximum of 52 weeks.
364455|NCT00718887|E2|Reported Event|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
364456|NCT00718887|E1|Reported Event|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
364457|NCT00718861|B3|Baseline|Total|Total of all reporting groups
364458|NCT00718861|B2|Baseline|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364459|NCT00718861|B1|Baseline|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364460|NCT00718861|P2|Participant Flow|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364461|NCT00718861|P1|Participant Flow|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364462|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364463|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364464|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364465|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364466|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364467|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364468|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364469|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364470|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364471|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364472|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364473|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364474|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364475|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364476|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364477|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364478|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364479|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364480|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364481|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364482|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364483|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364484|NCT00718861|E2|Reported Event|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
364485|NCT00718861|E1|Reported Event|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
364486|NCT00718809|B3|Baseline|Total|Total of all reporting groups
364487|NCT00718809|B2|Baseline|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364488|NCT00718809|B1|Baseline|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364489|NCT00718809|P2|Participant Flow|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364490|NCT00718809|P1|Participant Flow|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364491|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364492|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364493|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364494|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364495|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364496|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364497|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364498|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364499|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364500|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364501|NCT00718809|E2|Reported Event|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364502|NCT00718809|E1|Reported Event|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
364503|NCT00718770|B1|Baseline|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
364504|NCT00718770|P1|Participant Flow|Bexarotene|"Open label - all patients received the intervention~Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2."
364505|NCT00718770|O1|Outcome|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
364620|NCT00718042|B6|Baseline|Chagas Extended Evaluation|All subject's blood tested by the investigational Chagas screening test.
364506|NCT00718770|E1|Reported Event|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
364507|NCT00718640|B1|Baseline|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364508|NCT00718640|P1|Participant Flow|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364509|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364510|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364511|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364512|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364513|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364514|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364515|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364516|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364517|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364778|NCT00717249|B3|Baseline|Total|Total of all reporting groups
369121|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
364518|NCT00718640|E1|Reported Event|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
364519|NCT00718523|B3|Baseline|Total|Total of all reporting groups
364520|NCT00718523|B2|Baseline|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364521|NCT00718523|B1|Baseline|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364522|NCT00718523|P2|Participant Flow|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364523|NCT00718523|P1|Participant Flow|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364524|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364525|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364526|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364527|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364528|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364529|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364530|NCT00718523|E2|Reported Event|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
364531|NCT00718523|E1|Reported Event|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
364532|NCT00718315|B4|Baseline|Total|Total of all reporting groups
364533|NCT00718315|B3|Baseline|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364534|NCT00718315|B2|Baseline|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364535|NCT00718315|B1|Baseline|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364536|NCT00718315|P3|Participant Flow|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364537|NCT00718315|P2|Participant Flow|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364538|NCT00718315|P1|Participant Flow|Fisiogel|Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364539|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364540|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364541|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364542|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364543|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364544|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364545|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364546|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364547|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364548|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364549|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364550|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364551|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364552|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364553|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364554|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364555|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364556|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364557|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364558|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364559|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364560|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364561|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364562|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364563|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364564|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364565|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364566|NCT00718315|E3|Reported Event|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
364567|NCT00718315|E2|Reported Event|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364568|NCT00718315|E1|Reported Event|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
364569|NCT00718237|B3|Baseline|Total|Total of all reporting groups
365139|NCT00716456|B2|Baseline|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
364570|NCT00718237|B2|Baseline|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364571|NCT00718237|B1|Baseline|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
364572|NCT00718237|P2|Participant Flow|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364573|NCT00718237|P1|Participant Flow|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
364574|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study
364575|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364576|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364577|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
364578|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364579|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364580|NCT00718237|E2|Reported Event|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
364581|NCT00718237|E1|Reported Event|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
364582|NCT00718120|B3|Baseline|Total|Total of all reporting groups
364583|NCT00718120|B2|Baseline|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364584|NCT00718120|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364585|NCT00718120|P2|Participant Flow|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364586|NCT00718120|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364587|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364588|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364589|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364590|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364591|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364592|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364593|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364594|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364595|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364596|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364597|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364598|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364599|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364600|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364601|NCT00718120|E2|Reported Event|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
364602|NCT00718120|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
364603|NCT00718081|B4|Baseline|Total|Total of all reporting groups
364604|NCT00718081|B3|Baseline|Placebo NanoTab|
364605|NCT00718081|B2|Baseline|Sufentanil NanoTab 15 mcg|
364606|NCT00718081|B1|Baseline|Sufentanil NanoTab 10 mcg|
364607|NCT00718081|P3|Participant Flow|Placebo NanoTab|
364608|NCT00718081|P2|Participant Flow|Sufentanil NanoTab 15 mcg|
364609|NCT00718081|P1|Participant Flow|Sufentanil NanoTab 10 mcg|
364610|NCT00718081|O3|Outcome|Placebo NanoTab|
364611|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
364612|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
364613|NCT00718081|O3|Outcome|Placebo NanoTab|
364614|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
364615|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
364616|NCT00718081|E3|Reported Event|Placebo NanoTab|
364617|NCT00718081|E2|Reported Event|Sufentanil NanoTab 15 mcg|
364618|NCT00718081|E1|Reported Event|Sufentanil NanoTab 10 mcg|
364621|NCT00718042|B5|Baseline|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
364622|NCT00718042|B4|Baseline|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
364623|NCT00718042|B3|Baseline|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
364624|NCT00718042|B2|Baseline|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
364625|NCT00718042|B1|Baseline|ABBOTT PRISM Chagas Specificity|All subject's blood tested by the investigational Chagas screening test.
364626|NCT00718042|P6|Participant Flow|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
364627|NCT00718042|P5|Participant Flow|Chagas Extended Evaluation|US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
364628|NCT00718042|P4|Participant Flow|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
364629|NCT00718042|P3|Participant Flow|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
364630|NCT00718042|P2|Participant Flow|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
364631|NCT00718042|P1|Participant Flow|ABBOTT PRISM Chagas Specificity|All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
364632|NCT00718042|O1|Outcome|Reactivity in Chagas Endemic Population|Specimen from Chagas endemic area in South or Central America (524) under separate specimen collection protocol were tested with investigational ESA Chagas.
364633|NCT00718042|O1|Outcome|ESA Chagas Non-US Serologically Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols.
364634|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South or Central America under separate specimen collection protocols were tested with investigational with ESA Chagas.
364635|NCT00718042|O1|Outcome|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
364636|NCT00718042|O1|Outcome|ESA Chagas US Donor Specimen Testing|A total of 58 PRISM Chagas repeatedly reactive US blood donor specimens tested with both ESA Chagas and RIPA.
364637|NCT00718042|O1|Outcome|PRISM Chagas Reactivity Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
364638|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay.
364639|NCT00718042|O1|Outcome|Reactivity T Cruzi Antibody Positive|Specimen positive for T cruzi antibody collected in South America (85) under separate specimen collection protocol and unidentified US blood donor specimens repeatedly reactive by T cruzi antibody licensed screening assay (202) were tested with investigational PRISM Chagas screening assay.
364640|NCT00718042|O1|Outcome|ABBOTT PRISM Chagas Specificity|Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
364641|NCT00718042|E1|Reported Event|Donor Follow-up Specimen Collection|Blood donors
364642|NCT00717977|B1|Baseline|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364643|NCT00717977|P1|Participant Flow|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364644|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364645|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364646|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364647|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364648|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364649|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364650|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364651|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364652|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364653|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364654|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364655|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364656|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364657|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364658|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364659|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364660|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364661|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364662|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364663|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364664|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364665|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364666|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364667|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364668|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364669|NCT00717977|E1|Reported Event|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
364670|NCT00717886|B1|Baseline|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
364671|NCT00717886|P1|Participant Flow|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
364672|NCT00717886|O1|Outcome|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
364673|NCT00717886|E1|Reported Event|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
364674|NCT00717873|B3|Baseline|Total|Total of all reporting groups
364675|NCT00717873|B2|Baseline|CPT Arm|Airway clearance provided by manual CPT
364676|NCT00717873|B1|Baseline|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
364677|NCT00717873|P2|Participant Flow|CPT Arm|Airway clearance provided by manual CPT
364678|NCT00717873|P1|Participant Flow|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
364679|NCT00717873|O2|Outcome|CPT Arm|Airway clearance provided by manual CPT
364680|NCT00717873|O1|Outcome|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
364681|NCT00717873|E2|Reported Event|CPT Arm|Airway clearance provided by manual CPT
364682|NCT00717873|E1|Reported Event|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
364683|NCT00717860|B3|Baseline|Total|Total of all reporting groups
364684|NCT00717860|B2|Baseline|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364685|NCT00717860|B1|Baseline|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364686|NCT00717860|P2|Participant Flow|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364687|NCT00717860|P1|Participant Flow|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364688|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364689|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364690|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364691|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364692|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364693|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364694|NCT00717860|E2|Reported Event|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364695|NCT00717860|E1|Reported Event|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
364696|NCT00717756|B1|Baseline|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
364697|NCT00717756|P1|Participant Flow|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
364698|NCT00717756|O1|Outcome|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
364699|NCT00717756|E1|Reported Event|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
364700|NCT00717522|B1|Baseline|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
364701|NCT00717522|P1|Participant Flow|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
364702|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
364703|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
364704|NCT00717522|E1|Reported Event|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
364705|NCT00717418|B5|Baseline|Total|Total of all reporting groups
364706|NCT00717418|B4|Baseline|Missing Treatment Information|
364707|NCT00717418|B3|Baseline|Combination Treatments|
364708|NCT00717418|B2|Baseline|Artificial Tears Alone|
364709|NCT00717418|B1|Baseline|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
364710|NCT00717418|P4|Participant Flow|Missing Treatment Information|
364711|NCT00717418|P3|Participant Flow|Combination Treatments|
364712|NCT00717418|P2|Participant Flow|Artificial Tears Alone|
364713|NCT00717418|P1|Participant Flow|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
364714|NCT00717418|O1|Outcome|All Patients|
364715|NCT00717418|O1|Outcome|All Patients|
364716|NCT00717418|E1|Reported Event|All Patients|
364717|NCT00717405|B1|Baseline|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364718|NCT00717405|P1|Participant Flow|Bevacizumab + Trastuzumab Chemotherapy|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364779|NCT00717249|B2|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364928|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364719|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364720|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364721|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364722|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364723|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364724|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364725|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364726|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364780|NCT00717249|B1|Baseline|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364727|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364728|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364729|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364730|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364731|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364732|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364733|NCT00717405|E1|Reported Event|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
364734|NCT00717314|B3|Baseline|Total|Total of all reporting groups
364735|NCT00717314|B2|Baseline|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364781|NCT00717249|P2|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364782|NCT00717249|P1|Participant Flow|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364736|NCT00717314|B1|Baseline|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364737|NCT00717314|P2|Participant Flow|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364738|NCT00717314|P1|Participant Flow|Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)|Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364739|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364740|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364741|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364742|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364743|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364744|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364745|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364746|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364747|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364783|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364784|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364748|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364749|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364750|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364751|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364752|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364753|NCT00717314|E2|Reported Event|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364754|NCT00717314|E1|Reported Event|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
364755|NCT00717288|B4|Baseline|Total|Total of all reporting groups
364756|NCT00717288|B3|Baseline|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
364757|NCT00717288|B2|Baseline|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
364758|NCT00717288|B1|Baseline|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
364759|NCT00717288|P3|Participant Flow|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
364760|NCT00717288|P2|Participant Flow|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
364761|NCT00717288|P1|Participant Flow|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
364762|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects that reverted back to an insulin drip
364763|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects that reverted back to an insulin drip
364764|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects that reverted back to an insulin drip
364765|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects with a BG value <65 mg/dl
364766|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects with a BG value <65 mg/dl
364767|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects with a BG value <65 mg/dl
364768|NCT00717288|O3|Outcome|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
364769|NCT00717288|O2|Outcome|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
364770|NCT00717288|O1|Outcome|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
364771|NCT00717288|E3|Reported Event|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
364772|NCT00717288|E2|Reported Event|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
364773|NCT00717288|E1|Reported Event|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
364774|NCT00717275|B1|Baseline|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
364775|NCT00717275|P1|Participant Flow|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
364776|NCT00717275|O1|Outcome|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
364777|NCT00717275|E1|Reported Event|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
364786|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364787|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364788|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364789|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364790|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364791|NCT00717249|E2|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
364792|NCT00717249|E1|Reported Event|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
364793|NCT00717236|B3|Baseline|Total|Total of all reporting groups
364794|NCT00717236|B2|Baseline|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364795|NCT00717236|B1|Baseline|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364796|NCT00717236|P2|Participant Flow|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364797|NCT00717236|P1|Participant Flow|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364798|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364799|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364800|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364801|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364802|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364803|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364804|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364805|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364806|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364807|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364808|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364809|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364810|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364811|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364812|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364813|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364814|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364836|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364815|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364816|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364817|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364818|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364819|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364820|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364821|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364822|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364823|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364824|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364825|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364826|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364827|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364828|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364829|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364830|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364831|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364832|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364833|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364834|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364835|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364837|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364838|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364839|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364840|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364841|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364842|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364843|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364844|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364845|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364846|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364847|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364848|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364849|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364850|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364851|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364852|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364853|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364854|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364855|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364856|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364857|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364858|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364859|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364860|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364861|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
364862|NCT00717236|E3|Reported Event|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364863|NCT00717236|E2|Reported Event|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
364864|NCT00717236|E1|Reported Event|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
364865|NCT00717197|B1|Baseline|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
364866|NCT00717197|P1|Participant Flow|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
364867|NCT00717197|O1|Outcome|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
364868|NCT00717197|E1|Reported Event|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
364869|NCT00717093|B3|Baseline|Total|Total of all reporting groups
364870|NCT00717093|B2|Baseline|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364871|NCT00717093|B1|Baseline|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364872|NCT00717093|P2|Participant Flow|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364873|NCT00717093|P1|Participant Flow|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364874|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364875|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364876|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364877|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364878|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364879|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364880|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364881|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364882|NCT00717093|E2|Reported Event|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364926|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364883|NCT00717093|E1|Reported Event|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
364884|NCT00717067|B6|Baseline|Total|Total of all reporting groups
364885|NCT00717067|B5|Baseline|ESRD on Hemodialysis|Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
364886|NCT00717067|B4|Baseline|Severe Renal Impairment|Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
364887|NCT00717067|B3|Baseline|Moderate Renal Impairment|Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
364888|NCT00717067|B2|Baseline|Mild Renal Impairment|Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
364889|NCT00717067|B1|Baseline|Healthy Subjects|Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
364890|NCT00717067|P5|Participant Flow|ESRD: Single Dose|(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
364891|NCT00717067|P4|Participant Flow|Severe Renal Impairment|Maraviroc 300 mg single dose.
364892|NCT00717067|P3|Participant Flow|Moderate Renal Impairment|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364893|NCT00717067|P2|Participant Flow|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364894|NCT00717067|P1|Participant Flow|Healthy Subjects|(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364895|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364896|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364897|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364898|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364899|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364900|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364901|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364902|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364903|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364904|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364905|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364906|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364907|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364908|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364909|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364910|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364911|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364912|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364913|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364914|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364915|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364916|NCT00717067|O1|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis
364917|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364918|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364919|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364920|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364921|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364922|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364923|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364924|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364925|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364931|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364932|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364933|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364934|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364935|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364936|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364937|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364938|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364939|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364940|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364941|NCT00717067|O4|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364942|NCT00717067|O3|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364943|NCT00717067|O2|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364944|NCT00717067|O1|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364945|NCT00717067|O6|Outcome|ESRD|(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364946|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364947|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364948|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364949|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364950|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364951|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364952|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364953|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364954|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364955|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364956|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364957|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364958|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364959|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364960|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364961|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364962|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364963|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
364964|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364965|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364966|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364967|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
364968|NCT00717067|E7|Reported Event|ESRD: Dosing Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
364969|NCT00717067|E6|Reported Event|ESRD: Dosing After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
364970|NCT00717067|E5|Reported Event|Severe Renal Impairment:|Maraviroc 300 mg single dose.
364971|NCT00717067|E4|Reported Event|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
364972|NCT00717067|E3|Reported Event|Moderate Renal Impairment|Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364973|NCT00717067|E2|Reported Event|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364974|NCT00717067|E1|Reported Event|Healthy Subjects|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
364975|NCT00717054|B3|Baseline|Total|Total of all reporting groups
364976|NCT00717054|B2|Baseline|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364977|NCT00717054|B1|Baseline|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364978|NCT00717054|P2|Participant Flow|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364979|NCT00717054|P1|Participant Flow|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364980|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364981|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364982|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364983|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364984|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364985|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364986|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364987|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
365025|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
369122|NCT00706901|O2|Outcome|Arm 2 IHMD|In Home Messaging Device
364988|NCT00717054|E2|Reported Event|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364989|NCT00717054|E1|Reported Event|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
364990|NCT00717041|B1|Baseline|Presenting to the ED|Patients who present to the ED
364991|NCT00717041|P1|Participant Flow|Presenting to the ED|Patients who present to the ED
364992|NCT00717041|O2|Outcome|Cognitively Impaired in the ED|Patients presenting to the ED who have cognitive impairment
364993|NCT00717041|O1|Outcome|Depressed in the ED|Patients who present to the ED who test positive for depression
364994|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
364995|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
364996|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
364997|NCT00717041|E1|Reported Event|Presenting to the ED|Patients who present to the ED
364998|NCT00716963|B1|Baseline|Screening/Baseline Participants|
364999|NCT00716963|P6|Participant Flow|Placebo/Budesonide/Fluticasone|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
365000|NCT00716963|P5|Participant Flow|Placebo/Fluticasone/Budesonide|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
365001|NCT00716963|P4|Participant Flow|Budesonide/Placebo/Fluticasone|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
365002|NCT00716963|P3|Participant Flow|Budesonide/Fluticasone/Placebo|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
365003|NCT00716963|P2|Participant Flow|Fluticasone/Placebo/Budesonide|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
365004|NCT00716963|P1|Participant Flow|Fluticasone/Budesonide/Placebo|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
365005|NCT00716963|O3|Outcome|Placebo|
365006|NCT00716963|O2|Outcome|Budesonide 400mcg|
365007|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
365008|NCT00716963|O3|Outcome|Placebo|
365009|NCT00716963|O2|Outcome|Budesonide 400mcg|
365010|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
365011|NCT00716963|E3|Reported Event|Placebo|
365012|NCT00716963|E2|Reported Event|Budesonide 400mcg|
365013|NCT00716963|E1|Reported Event|Fluticasone Propionate (Flovent Diskus) 250 mcg|
365014|NCT00716859|B3|Baseline|Total|Total of all reporting groups
365015|NCT00716859|B2|Baseline|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365016|NCT00716859|B1|Baseline|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365017|NCT00716859|P2|Participant Flow|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365018|NCT00716859|P1|Participant Flow|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365019|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365020|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365021|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365022|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365023|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365024|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365026|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365027|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365028|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365029|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365030|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365031|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365032|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365033|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365034|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365035|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365036|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365037|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365038|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365039|NCT00716859|E2|Reported Event|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
365040|NCT00716859|E1|Reported Event|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
365041|NCT00716820|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365042|NCT00716820|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365043|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365044|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365045|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365046|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365047|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365048|NCT00716820|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
365049|NCT00716820|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
365050|NCT00716820|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
365051|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
365052|NCT00716820|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
365053|NCT00716820|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
365054|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365055|NCT00716820|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365056|NCT00716820|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365057|NCT00716820|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
365058|NCT00716820|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
365059|NCT00716820|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
365060|NCT00716820|O3|Outcome|Unknown|Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert
365061|NCT00716820|O2|Outcome|PDGFRα Without Mutation|Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert
365062|NCT00716820|O1|Outcome|PDGFRα With Mutation|Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert
365063|NCT00716820|O3|Outcome|Unknown|Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert
365064|NCT00716820|O2|Outcome|c-Kit Without Mutation|Participants without c-kit mutation who received sunitinib malate according to Japanese package insert
365065|NCT00716820|O1|Outcome|c-Kit With Mutation|Participants with c-kit mutation who received sunitinib malate according to Japanese package insert
365066|NCT00716820|O3|Outcome|Unknown|Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert
365067|NCT00716820|O2|Outcome|KIT Negative|Participants with negative KIT expression who received sunitinib malate according to Japanese package insert
365068|NCT00716820|O1|Outcome|KIT Positive|Participants with positive KIT expression who received sunitinib malate according to Japanese package insert
365069|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365070|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365071|NCT00716820|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365072|NCT00716807|B5|Baseline|Total|Total of all reporting groups
365073|NCT00716807|B4|Baseline|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365074|NCT00716807|B3|Baseline|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365075|NCT00716807|B2|Baseline|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365076|NCT00716807|B1|Baseline|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365077|NCT00716807|P4|Participant Flow|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365078|NCT00716807|P3|Participant Flow|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365079|NCT00716807|P2|Participant Flow|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365080|NCT00716807|P1|Participant Flow|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365081|NCT00716807|O4|Outcome|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365082|NCT00716807|O3|Outcome|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365083|NCT00716807|O2|Outcome|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365084|NCT00716807|O1|Outcome|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365085|NCT00716807|E4|Reported Event|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365086|NCT00716807|E3|Reported Event|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365087|NCT00716807|E2|Reported Event|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
365088|NCT00716807|E1|Reported Event|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
365089|NCT00716742|B4|Baseline|Total|Total of all reporting groups
365090|NCT00716742|B3|Baseline|Xalatan®|latanoprost 0.005%
365091|NCT00716742|B2|Baseline|Travatan®|travoprost 0.004%
365092|NCT00716742|B1|Baseline|Lumigan®|bimatoprost 0.03%
365093|NCT00716742|P3|Participant Flow|Xalatan®|latanoprost 0.005%
365094|NCT00716742|P2|Participant Flow|Travatan®|travoprost 0.004%
365095|NCT00716742|P1|Participant Flow|Lumigan®|bimatoprost 0.03%
365096|NCT00716742|O3|Outcome|Xalatan®|latanoprost 0.005%
365097|NCT00716742|O2|Outcome|Travatan®|travoprost 0.004%
365098|NCT00716742|O1|Outcome|Lumigan®|bimatoprost 0.03%
365099|NCT00716742|E3|Reported Event|Xalatan®|latanoprost 0.005%
365100|NCT00716742|E2|Reported Event|Travatan®|travoprost 0.004%
365102|NCT00716625|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365103|NCT00716625|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365104|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365105|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365106|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365107|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365108|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365109|NCT00716625|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
365110|NCT00716625|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
365111|NCT00716625|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
365112|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
365113|NCT00716625|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
365114|NCT00716625|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
365115|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365116|NCT00716625|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365117|NCT00716625|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
365118|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
365119|NCT00716625|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
365120|NCT00716625|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
365121|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
365122|NCT00716625|O2|Outcome|Adult|Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert
365123|NCT00716625|O1|Outcome|Pediatric|Participants aged ˂15 years who received sunitinib malate according to Japanese package insert
365124|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365125|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365126|NCT00716625|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
365127|NCT00716482|B1|Baseline|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
365128|NCT00716482|P1|Participant Flow|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
365129|NCT00716482|O1|Outcome|Overall (All Masses)|Benign and malignant lesions
365130|NCT00716482|O1|Outcome|Overall (All Masses)|614 benign and 144 malignant masses
365131|NCT00716482|O3|Outcome|Not Homogeneous|"The Elastography image of the lesion is inhomogeneous and has a mottled or patchy appearance throughout."
365132|NCT00716482|O2|Outcome|Reasonably Homogeneous|"The Elastography image of the lesion has a slightly patchy appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small."
365133|NCT00716482|O1|Outcome|Very Homogeneous|The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.
365134|NCT00716482|O2|Outcome|Sensitivity|Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
365135|NCT00716482|O1|Outcome|Specificity|Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
365136|NCT00716482|E1|Reported Event|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
365137|NCT00716456|B4|Baseline|Total|Total of all reporting groups
365138|NCT00716456|B3|Baseline|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
365140|NCT00716456|B1|Baseline|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
365141|NCT00716456|P3|Participant Flow|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
365142|NCT00716456|P2|Participant Flow|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
365143|NCT00716456|P1|Participant Flow|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
365144|NCT00716456|O3|Outcome|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
365145|NCT00716456|O2|Outcome|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
365146|NCT00716456|O1|Outcome|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
365147|NCT00716456|E3|Reported Event|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
365148|NCT00716456|E2|Reported Event|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
365149|NCT00716456|E1|Reported Event|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
365150|NCT00716443|B1|Baseline|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
365151|NCT00716443|P1|Participant Flow|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
365152|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365153|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365154|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365155|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365156|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365157|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365158|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365159|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365160|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365161|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365162|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365163|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365164|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365165|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365166|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365167|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365168|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365169|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365170|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365171|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365172|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365173|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365174|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365175|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365176|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365177|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365178|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365179|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365180|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
365181|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
365182|NCT00716443|E1|Reported Event|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
365183|NCT00716417|B11|Baseline|Total|Total of all reporting groups
365184|NCT00716417|B10|Baseline|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365185|NCT00716417|B9|Baseline|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365186|NCT00716417|B8|Baseline|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365187|NCT00716417|B7|Baseline|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365188|NCT00716417|B6|Baseline|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365312|NCT00715910|B1|Baseline|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365189|NCT00716417|B5|Baseline|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365190|NCT00716417|B4|Baseline|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365191|NCT00716417|B3|Baseline|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365192|NCT00716417|B2|Baseline|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365193|NCT00716417|B1|Baseline|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365194|NCT00716417|P10|Participant Flow|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365195|NCT00716417|P9|Participant Flow|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365196|NCT00716417|P8|Participant Flow|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365197|NCT00716417|P7|Participant Flow|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365198|NCT00716417|P6|Participant Flow|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365199|NCT00716417|P5|Participant Flow|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365200|NCT00716417|P4|Participant Flow|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365201|NCT00716417|P3|Participant Flow|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365202|NCT00716417|P2|Participant Flow|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365203|NCT00716417|P1|Participant Flow|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365204|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365205|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365206|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365207|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365208|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365209|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365210|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365211|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365212|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365213|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365214|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365215|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365216|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365217|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365218|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365219|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365220|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365221|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365222|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365223|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365224|NCT00716417|O2|Outcome|5FU + Cis + Afatinib (Regimen B)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
365225|NCT00716417|O1|Outcome|Pac + Cis + Afatinib (Regimen A)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
365226|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365227|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365228|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365229|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365230|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365231|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365232|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365233|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365234|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365235|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365236|NCT00716417|E10|Reported Event|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
369123|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
365237|NCT00716417|E9|Reported Event|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365238|NCT00716417|E8|Reported Event|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365239|NCT00716417|E7|Reported Event|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365240|NCT00716417|E6|Reported Event|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365241|NCT00716417|E5|Reported Event|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365242|NCT00716417|E4|Reported Event|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365243|NCT00716417|E3|Reported Event|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365244|NCT00716417|E2|Reported Event|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365245|NCT00716417|E1|Reported Event|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
365246|NCT00716092|B4|Baseline|Total|Total of all reporting groups
365247|NCT00716092|B3|Baseline|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365248|NCT00716092|B2|Baseline|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365249|NCT00716092|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
365250|NCT00716092|P3|Participant Flow|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365251|NCT00716092|P2|Participant Flow|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365252|NCT00716092|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
365253|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365254|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365255|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365256|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365257|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365258|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365259|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365260|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365261|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365262|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365263|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365264|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365265|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365266|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365267|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365268|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365269|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365270|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365271|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365272|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365273|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365274|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365275|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365276|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
365277|NCT00716092|E3|Reported Event|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
365278|NCT00716092|E2|Reported Event|BI1356|Patients randomized to receive treatment with BI1356 5 mg
365279|NCT00716092|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
365280|NCT00716079|B3|Baseline|Total|Total of all reporting groups
365294|NCT00715962|P2|Participant Flow|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365424|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365281|NCT00716079|B2|Baseline|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365282|NCT00716079|B1|Baseline|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365283|NCT00716079|P2|Participant Flow|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365284|NCT00716079|P1|Participant Flow|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365285|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365286|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365287|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365288|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365289|NCT00716079|E2|Reported Event|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365290|NCT00716079|E1|Reported Event|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
365291|NCT00715962|B3|Baseline|Total|Total of all reporting groups
365292|NCT00715962|B2|Baseline|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365293|NCT00715962|B1|Baseline|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365295|NCT00715962|P1|Participant Flow|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365296|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365297|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365298|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365299|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365300|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365301|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus a behavioral intervention that encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365302|NCT00715962|E2|Reported Event|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
365303|NCT00715962|E1|Reported Event|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
365304|NCT00715949|B1|Baseline|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
365305|NCT00715949|P1|Participant Flow|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
365306|NCT00715949|O1|Outcome|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
365307|NCT00715949|E1|Reported Event|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
365308|NCT00715910|B5|Baseline|Total|Total of all reporting groups
365309|NCT00715910|B4|Baseline|Nimenrix naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365310|NCT00715910|B3|Baseline|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365311|NCT00715910|B2|Baseline|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365425|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365313|NCT00715910|P6|Participant Flow|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365314|NCT00715910|P5|Participant Flow|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365315|NCT00715910|P4|Participant Flow|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365316|NCT00715910|P3|Participant Flow|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365317|NCT00715910|P2|Participant Flow|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365318|NCT00715910|P1|Participant Flow|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365319|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365320|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365321|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365322|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365323|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365324|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365325|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365326|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365327|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365328|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365329|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365330|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365331|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365332|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365333|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365334|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365335|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365371|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365336|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365337|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365338|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365339|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365340|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5
365341|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365342|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365343|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365344|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365345|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365346|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365347|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365348|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365349|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365350|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365351|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365352|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365353|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365354|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365355|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365356|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365357|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365358|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365359|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365360|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365361|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365362|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365363|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365364|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365365|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365366|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365367|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365368|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365369|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365370|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365423|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365372|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365373|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365374|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365375|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365376|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365377|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365378|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365379|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365380|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365381|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365382|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365383|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365384|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365385|NCT00715910|E6|Reported Event|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365386|NCT00715910|E5|Reported Event|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365387|NCT00715910|E4|Reported Event|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
365388|NCT00715910|E3|Reported Event|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365389|NCT00715910|E2|Reported Event|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
365390|NCT00715910|E1|Reported Event|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
365391|NCT00715884|B3|Baseline|Total|Total of all reporting groups
365392|NCT00715884|B2|Baseline|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365393|NCT00715884|B1|Baseline|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365394|NCT00715884|P2|Participant Flow|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365395|NCT00715884|P1|Participant Flow|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365396|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365397|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365398|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365399|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365400|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365401|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365402|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365403|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365404|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365405|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365406|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365407|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365408|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365409|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365410|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365411|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365412|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365413|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365414|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365415|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365416|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365417|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365418|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365419|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365420|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365421|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365422|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
369124|NCT00706901|E3|Reported Event|Arm 3 TCC|Treatment Control Condition
365426|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365427|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365428|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365429|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365430|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365431|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365432|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365433|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365434|NCT00715884|E2|Reported Event|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
365435|NCT00715884|E1|Reported Event|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
365436|NCT00715754|B1|Baseline|Infants|
365437|NCT00715754|P1|Participant Flow|All Infants|One group comprised all infants evaluated.
365438|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
365439|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
365440|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
365441|NCT00715754|E1|Reported Event|All Infants|One group comprised all infants evaluated.
365442|NCT00715741|B5|Baseline|Total|Total of all reporting groups
365443|NCT00715741|B4|Baseline|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365444|NCT00715741|B3|Baseline|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365445|NCT00715741|B2|Baseline|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365446|NCT00715741|B1|Baseline|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365447|NCT00715741|P4|Participant Flow|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365448|NCT00715741|P3|Participant Flow|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365449|NCT00715741|P2|Participant Flow|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365450|NCT00715741|P1|Participant Flow|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365451|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365452|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365453|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365454|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365455|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365456|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365457|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365458|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365459|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365460|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365461|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365462|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365463|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365464|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365465|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365466|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365467|NCT00715741|E4|Reported Event|Fi02 0.9 Without PEEP|90% oxygen without PEEP
365468|NCT00715741|E3|Reported Event|Fi02 0.9 With PEEP|90% oxygen plus PEEP
365469|NCT00715741|E2|Reported Event|Fi02 0.3 Without PEEP|30% oxygen without PEEP
365470|NCT00715741|E1|Reported Event|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
365471|NCT00715676|B4|Baseline|Total|Total of all reporting groups
365472|NCT00715676|B3|Baseline|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365473|NCT00715676|B2|Baseline|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365474|NCT00715676|B1|Baseline|Placebo|Placebo soft gel capsules, oral, once daily
365475|NCT00715676|P3|Participant Flow|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365476|NCT00715676|P2|Participant Flow|220 ng of Vitamin D Analog (DP001)|220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
365477|NCT00715676|P1|Participant Flow|Placebo|Placebo soft gel capsules, oral, once daily
365478|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365479|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365480|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365481|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365482|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365483|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365484|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365485|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365486|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365487|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365488|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365489|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365490|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365491|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365492|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365493|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365494|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365495|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365496|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365497|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365498|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
365499|NCT00715676|E3|Reported Event|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
365500|NCT00715676|E2|Reported Event|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
365501|NCT00715676|E1|Reported Event|Placebo|Placebo soft gel capsules, oral, once daily
365502|NCT00715650|B3|Baseline|Total|Total of all reporting groups
365503|NCT00715650|B2|Baseline|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365504|NCT00715650|B1|Baseline|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365505|NCT00715650|P2|Participant Flow|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365506|NCT00715650|P1|Participant Flow|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365507|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365508|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365509|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365510|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365511|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365512|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365513|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365514|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365515|NCT00715650|E2|Reported Event|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
365516|NCT00715650|E1|Reported Event|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
365517|NCT00715624|B3|Baseline|Total|Total of all reporting groups
365518|NCT00715624|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
365519|NCT00715624|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
365520|NCT00715624|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
365521|NCT00715624|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
365522|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365523|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365524|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365525|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365526|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365527|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365528|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365529|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365530|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365531|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365532|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365533|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365534|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365535|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365536|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365537|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365538|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365539|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365540|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365541|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365542|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365543|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365544|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365545|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365546|NCT00715624|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
365547|NCT00715624|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
365548|NCT00715559|B1|Baseline|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365549|NCT00715559|P1|Participant Flow|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365550|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365551|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365552|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365553|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365554|NCT00715559|E1|Reported Event|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
365555|NCT00715403|B8|Baseline|Total|Total of all reporting groups
365556|NCT00715403|B7|Baseline|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365557|NCT00715403|B6|Baseline|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365558|NCT00715403|B5|Baseline|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365559|NCT00715403|B4|Baseline|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365560|NCT00715403|B3|Baseline|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365561|NCT00715403|B2|Baseline|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365562|NCT00715403|B1|Baseline|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365563|NCT00715403|P7|Participant Flow|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365564|NCT00715403|P6|Participant Flow|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365565|NCT00715403|P5|Participant Flow|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365566|NCT00715403|P4|Participant Flow|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365567|NCT00715403|P3|Participant Flow|100mg BID|Patients were treated with 100 mg Nintedanib twice daily (BID).
365568|NCT00715403|P2|Participant Flow|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365569|NCT00715403|P1|Participant Flow|50mg QD|Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
365570|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365571|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365572|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365573|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365574|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365575|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365576|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365577|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365578|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365579|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365580|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365581|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365582|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365583|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365584|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365585|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365586|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365587|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365588|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365589|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365590|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365591|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365592|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365593|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365594|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365595|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365596|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365597|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365598|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365599|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365600|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365601|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365602|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365603|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365604|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365605|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365606|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365607|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365608|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365609|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365610|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365611|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365612|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365613|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365614|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365615|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365616|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365617|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365618|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365619|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365620|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365621|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365622|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365623|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365624|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365625|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365626|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365627|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365628|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365629|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365630|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365631|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365632|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365633|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365634|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365635|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365636|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365637|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365638|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365639|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365640|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365641|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365642|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365643|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365644|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365645|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365646|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365647|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365648|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365649|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365650|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365651|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365652|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365653|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365654|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365655|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365656|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365657|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365658|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365659|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365660|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365661|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365662|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365663|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365664|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365665|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365666|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365667|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365668|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365669|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365670|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365671|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365672|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365673|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365674|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365675|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365676|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365677|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365678|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365679|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365680|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365681|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365682|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365683|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365684|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365685|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365686|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365687|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365688|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365689|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365690|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365691|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365692|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365693|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365694|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365695|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365696|NCT00715403|E7|Reported Event|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
365697|NCT00715403|E6|Reported Event|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
365698|NCT00715403|E5|Reported Event|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
365699|NCT00715403|E4|Reported Event|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
365700|NCT00715403|E3|Reported Event|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
365701|NCT00715403|E2|Reported Event|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
365702|NCT00715403|E1|Reported Event|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
365703|NCT00715390|B1|Baseline|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
365704|NCT00715390|P1|Participant Flow|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
365705|NCT00715390|O1|Outcome|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
365706|NCT00715390|E1|Reported Event|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
365707|NCT00715299|B1|Baseline|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
365708|NCT00715299|P1|Participant Flow|Total Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
365709|NCT00715299|O1|Outcome|Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.~18 responded with a walking speed greater than 0.16 m/s, while 9 has a change < 0.16 m/s."
365757|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
365710|NCT00715299|E1|Reported Event|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
365711|NCT00715208|B3|Baseline|Total|Total of all reporting groups
365712|NCT00715208|B2|Baseline|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365713|NCT00715208|B1|Baseline|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365714|NCT00715208|P2|Participant Flow|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365715|NCT00715208|P1|Participant Flow|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365716|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365717|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365718|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365719|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365720|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365721|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365722|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365723|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365724|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365725|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365726|NCT00715208|E2|Reported Event|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
365727|NCT00715208|E1|Reported Event|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
365728|NCT00715117|B3|Baseline|Total|Total of all reporting groups
365729|NCT00715117|B2|Baseline|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks
365730|NCT00715117|B1|Baseline|A: Placebo Control Group|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks
365731|NCT00715117|P2|Participant Flow|B: Naltrexone Then Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks
365732|NCT00715117|P1|Participant Flow|A: Placebo Then Naltrexone|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks
365733|NCT00715117|O2|Outcome|Naltrexone|These subjects were treated with naltrexone at a dose 0.1 mg/kg not to exceed 4.5 mg po daily for either 8 or 16 weeks.
365734|NCT00715117|O1|Outcome|Placebo|These subjects received placebo for 8 weeks by mouth daily.
365735|NCT00715117|O2|Outcome|Week 16|Quality of life survey values in all subjects determined at week 16 after all 12 participants had received naltrexone for either 8 or 16 weeks.
365736|NCT00715117|O1|Outcome|Baseline|Quality of life values in all subjects at baseline before receiving placebo or naltrexone.
365737|NCT00715117|O3|Outcome|Naltrexone|Includes all Naltrexone treated participants 8 weeks of treatment.
365738|NCT00715117|O2|Outcome|Placebo|Patients were treated with a placebo (sugar pill)for 8 weeks.
365739|NCT00715117|O1|Outcome|All Participants Pretreament|All participants prior to receiving placebo or naltrexone at week 0
365740|NCT00715117|E2|Reported Event|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
365741|NCT00715117|E1|Reported Event|A: Placebo Control Group|Subjects will receive placebo for 8weeks
365742|NCT00715104|B4|Baseline|Total|Total of all reporting groups
365743|NCT00715104|B3|Baseline|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase(received no further sipuleucel-T treatment).
365744|NCT00715104|B2|Baseline|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
365745|NCT00715104|B1|Baseline|Sipuleucel-T With Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
365746|NCT00715104|P3|Participant Flow|Sipuleucel-T Without Randomization to Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
365747|NCT00715104|P2|Participant Flow|Sipuleucel-T Without Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
365748|NCT00715104|P1|Participant Flow|Sipuleucel-T With Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
365749|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster
365750|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
365751|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
365752|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
365753|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
365754|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
365755|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
365756|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
365758|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
365759|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
365760|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
365761|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
365762|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
365763|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
365764|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
365765|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
365766|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
365767|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
365768|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
365769|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
365770|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
365771|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
365772|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
365773|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PAP at 12 Weeks post-RP
365774|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PAP at 6 Weeks post-RP
365775|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PAP at pre-RP visit
365776|NCT00715104|O1|Outcome|Baseline|ELISPOT for PAP at baseline
365777|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PA2024 at 12 Weeks post-RP
365778|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PA2024 at 6 Weeks post-RP
365779|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PA2024 at Pre-RP Visit
365780|NCT00715104|O1|Outcome|Baseline|ELISPOT for PA2024 at baseline
365781|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
365782|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
365783|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
365784|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
365785|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
365786|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
365787|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
365788|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
365789|NCT00715104|O4|Outcome|Post-RP Tumor Interface|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
365790|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
365791|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
365792|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
365793|NCT00715104|E3|Reported Event|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
365794|NCT00715104|E2|Reported Event|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
365795|NCT00715104|E1|Reported Event|Sipuleucel-T With Booster|Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
365796|NCT00715078|B4|Baseline|Total|Total of all reporting groups
365797|NCT00715078|B3|Baseline|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
365798|NCT00715078|B2|Baseline|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
365799|NCT00715078|B1|Baseline|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 107 peripheral blood mononuclear cells (PBMCs) per mL
365800|NCT00715078|P3|Participant Flow|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
365801|NCT00715078|P2|Participant Flow|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
365802|NCT00715078|P1|Participant Flow|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
365803|NCT00715078|O3|Outcome|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
365804|NCT00715078|O2|Outcome|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
365805|NCT00715078|O1|Outcome|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
365806|NCT00715078|E3|Reported Event|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
365807|NCT00715078|E2|Reported Event|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
365808|NCT00715078|E1|Reported Event|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
365809|NCT00715026|B1|Baseline|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
365810|NCT00715026|P1|Participant Flow|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
365811|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
365812|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
365813|NCT00715026|E1|Reported Event|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
365814|NCT00714948|B1|Baseline|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
365815|NCT00714948|P1|Participant Flow|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
365816|NCT00714948|O1|Outcome|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
365817|NCT00714948|E1|Reported Event|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
365818|NCT00714870|B3|Baseline|Total|Total of all reporting groups
365819|NCT00714870|B2|Baseline|Control Group|control group: this group will not attend the nutrition and exercise program
365820|NCT00714870|B1|Baseline|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
365821|NCT00714870|P2|Participant Flow|Control Group: Standard of Care at Pediatrician's Office|control group: this group will not attend the nutrition and exercise program
365822|NCT00714870|P1|Participant Flow|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
365823|NCT00714870|O2|Outcome|Control|Control group received the standard of care at pediatrician's office
365824|NCT00714870|O1|Outcome|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
365825|NCT00714870|E2|Reported Event|Control|
365826|NCT00714870|E1|Reported Event|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
365827|NCT00714714|B1|Baseline|Combined Arms|All subjects received treatment with both gels in a split-face model
365828|NCT00714714|P1|Participant Flow|Combined Arms|All subjects received treatment with both gels in a split-face model
365829|NCT00714714|O2|Outcome|Tretinoin|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
365876|NCT00714571|E4|Reported Event|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
365877|NCT00714571|E3|Reported Event|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
365830|NCT00714714|O1|Outcome|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
365831|NCT00714714|E2|Reported Event|Tretinion|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
365832|NCT00714714|E1|Reported Event|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
365833|NCT00714688|B4|Baseline|Total|Total of all reporting groups
365834|NCT00714688|B3|Baseline|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365835|NCT00714688|B2|Baseline|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365836|NCT00714688|B1|Baseline|Placebo|2 tablets placebo once daily for 13 weeks
365837|NCT00714688|P3|Participant Flow|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365838|NCT00714688|P2|Participant Flow|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365839|NCT00714688|P1|Participant Flow|Placebo|2 tablets placebo once daily for 13 weeks
365840|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365841|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365842|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
365843|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365844|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365845|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
365846|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365847|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365848|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
365849|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365850|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365851|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
365852|NCT00714688|E3|Reported Event|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
365853|NCT00714688|E2|Reported Event|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
365854|NCT00714688|E1|Reported Event|Placebo|2 tablets placebo once daily for 13 weeks
365855|NCT00714571|B7|Baseline|Total|Total of all reporting groups
365856|NCT00714571|B6|Baseline|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
365857|NCT00714571|B5|Baseline|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
365858|NCT00714571|B4|Baseline|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
365859|NCT00714571|B3|Baseline|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
365860|NCT00714571|B2|Baseline|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
365861|NCT00714571|B1|Baseline|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
365862|NCT00714571|P6|Participant Flow|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
365863|NCT00714571|P5|Participant Flow|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
365864|NCT00714571|P4|Participant Flow|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
365865|NCT00714571|P3|Participant Flow|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
365866|NCT00714571|P2|Participant Flow|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
365867|NCT00714571|P1|Participant Flow|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
365868|NCT00714571|O6|Outcome|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
365869|NCT00714571|O5|Outcome|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
365870|NCT00714571|O4|Outcome|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
365871|NCT00714571|O3|Outcome|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
365872|NCT00714571|O2|Outcome|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
365873|NCT00714571|O1|Outcome|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
365874|NCT00714571|E6|Reported Event|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
365875|NCT00714571|E5|Reported Event|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
365878|NCT00714571|E2|Reported Event|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
365879|NCT00714571|E1|Reported Event|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
365880|NCT00714493|B1|Baseline|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
365881|NCT00714493|P1|Participant Flow|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
365882|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365883|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365884|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365885|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365886|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365887|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365888|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
365889|NCT00714493|E1|Reported Event|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
365890|NCT00714389|B1|Baseline|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
365891|NCT00714389|P1|Participant Flow|Spontaneous Uroflow Measurements|Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
365892|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
365893|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
365894|NCT00714389|E1|Reported Event|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
365895|NCT00714311|B3|Baseline|Total|Total of all reporting groups
365896|NCT00714311|B2|Baseline|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
365897|NCT00714311|B1|Baseline|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
365898|NCT00714311|P2|Participant Flow|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
365899|NCT00714311|P1|Participant Flow|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
365900|NCT00714311|O2|Outcome|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
365901|NCT00714311|O1|Outcome|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
365902|NCT00714311|E2|Reported Event|Treatment by Experienced Community Psychotherapists|"treatment by experienced community psychotherapists (ECP)~treatment by experienced community psychotherapists: Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned."
365903|NCT00714311|E1|Reported Event|Transference-Focused Psychotherapy|"Transference-Focused Psychotherapy (TFP)~Transference-Focused Psychotherapy: Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week"
365904|NCT00714285|B5|Baseline|Total|Total of all reporting groups
365905|NCT00714285|B4|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365906|NCT00714285|B3|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365907|NCT00714285|B2|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365908|NCT00714285|B1|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365909|NCT00714285|P4|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365910|NCT00714285|P3|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365911|NCT00714285|P2|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365912|NCT00714285|P1|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365913|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365914|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365915|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
366043|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
365916|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365917|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365918|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365919|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365920|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365921|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365922|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365923|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365924|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365925|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365926|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365927|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365928|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365929|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365930|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365931|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365932|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365933|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365934|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365935|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365936|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365937|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365938|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365939|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365940|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365941|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365942|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
366044|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
365943|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365944|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365945|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365946|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365947|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365948|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365949|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365950|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365951|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365952|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365953|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365954|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
365955|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365956|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365957|NCT00714285|E4|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365958|NCT00714285|E3|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365959|NCT00714285|E2|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365960|NCT00714285|E1|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
365961|NCT00714233|B5|Baseline|Total|Total of all reporting groups
365962|NCT00714233|B4|Baseline|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365963|NCT00714233|B3|Baseline|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365964|NCT00714233|B2|Baseline|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365965|NCT00714233|B1|Baseline|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365966|NCT00714233|P4|Participant Flow|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365967|NCT00714233|P3|Participant Flow|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365968|NCT00714233|P2|Participant Flow|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365969|NCT00714233|P1|Participant Flow|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365970|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365971|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365972|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365973|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365974|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365975|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365976|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365977|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365978|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
369125|NCT00706901|E2|Reported Event|Arm 2 IHMD|In Home Messaging Device
365979|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365980|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365981|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365982|NCT00714233|O4|Outcome|Placebo to Metformin|Matched to metformin pill
365983|NCT00714233|O3|Outcome|Lifestle|Those assigned to a nutrition and exercise program
365984|NCT00714233|O2|Outcome|Oral Contraceptive|group assigned to oral contraceptive for 24 weeks
365985|NCT00714233|O1|Outcome|Metformin|Group assigned to metformin with free androgen index measured
365986|NCT00714233|O1|Outcome|Lifestyle Program|Subjects enrolled in a nutrition and exercise program
365987|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365988|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365989|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365990|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365991|NCT00714233|E4|Reported Event|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
365992|NCT00714233|E3|Reported Event|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
365993|NCT00714233|E2|Reported Event|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
365994|NCT00714233|E1|Reported Event|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
365995|NCT00714168|B3|Baseline|Total|Total of all reporting groups
365996|NCT00714168|B2|Baseline|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
365997|NCT00714168|B1|Baseline|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
365998|NCT00714168|P2|Participant Flow|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
365999|NCT00714168|P1|Participant Flow|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366000|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366001|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366002|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366003|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366004|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366005|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366006|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366007|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366008|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366009|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366010|NCT00714168|E2|Reported Event|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
366011|NCT00714168|E1|Reported Event|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
366012|NCT00714051|B3|Baseline|Total|Total of all reporting groups
366013|NCT00714051|B2|Baseline|Control Group|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
366014|NCT00714051|B1|Baseline|Falls Prevention Training Group|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
366015|NCT00714051|P2|Participant Flow|Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
366016|NCT00714051|P1|Participant Flow|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
366017|NCT00714051|O2|Outcome|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
366018|NCT00714051|O1|Outcome|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
366019|NCT00714051|E2|Reported Event|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
366020|NCT00714051|E1|Reported Event|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
366021|NCT00713830|B3|Baseline|Total|Total of all reporting groups
366022|NCT00713830|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
366023|NCT00713830|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
366024|NCT00713830|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
366025|NCT00713830|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
366026|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366027|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366028|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366029|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366030|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366031|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366032|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366033|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366034|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366035|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366036|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366037|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366038|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366039|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366040|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366041|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366042|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366045|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366046|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366047|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366048|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366049|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366050|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366051|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366052|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366053|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366054|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366055|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366056|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
366057|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
366058|NCT00713830|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
366059|NCT00713830|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
366060|NCT00713817|B3|Baseline|Total|Total of all reporting groups
366061|NCT00713817|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366062|NCT00713817|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366063|NCT00713817|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366064|NCT00713817|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366065|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366066|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366067|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366068|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366069|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366070|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366071|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366072|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366073|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366074|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366075|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366076|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366077|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366078|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366079|NCT00713817|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
366080|NCT00713817|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
366081|NCT00713700|B1|Baseline|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
366082|NCT00713700|P1|Participant Flow|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
366083|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
366084|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
366085|NCT00713700|E1|Reported Event|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
366086|NCT00713661|B5|Baseline|Total|Total of all reporting groups
366087|NCT00713661|B4|Baseline|Group 4: Laparoscopic Surgery Middle/Upper|
366088|NCT00713661|B3|Baseline|Group 3: Laparoscopic Surgery Lower|
366089|NCT00713661|B2|Baseline|Group 2: Open Surgery Middle/Upper|
366090|NCT00713661|B1|Baseline|Group 1: Open Surgery Lower|
366091|NCT00713661|P4|Participant Flow|Group 4: Laparoscopic Surgery Middle/Upper|Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
366092|NCT00713661|P3|Participant Flow|Group 3: Laparoscopic Surgery Lower|Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
366093|NCT00713661|P2|Participant Flow|Group 2: Open Surgery Middle/Upper|Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.
366094|NCT00713661|P1|Participant Flow|Group 1: Open Surgery Lower|Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
366095|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
366096|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
366097|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
366098|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
366099|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
366100|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
366101|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
366102|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
366103|NCT00713661|E4|Reported Event|Group 4: Laparoscopic Surgery Middle/Upper|
366104|NCT00713661|E3|Reported Event|Group 3: Laparoscopic Surgery Lower|
366105|NCT00713661|E2|Reported Event|Group 2: Open Surgery Middle/Upper|
366106|NCT00713661|E1|Reported Event|Group 1: Open Surgery Lower|
366107|NCT00713648|B1|Baseline|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366108|NCT00713648|P1|Participant Flow|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366109|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366110|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366111|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366112|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366113|NCT00713648|E1|Reported Event|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
366114|NCT00713596|B4|Baseline|Total|Total of all reporting groups
366115|NCT00713596|B3|Baseline|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
366116|NCT00713596|B2|Baseline|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
366117|NCT00713596|B1|Baseline|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
366118|NCT00713596|P3|Participant Flow|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
366119|NCT00713596|P2|Participant Flow|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
366120|NCT00713596|P1|Participant Flow|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
366121|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
366122|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
366123|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
366175|NCT00713544|E4|Reported Event|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366124|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
366125|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
366126|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
366127|NCT00713596|E3|Reported Event|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
366128|NCT00713596|E2|Reported Event|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
366129|NCT00713596|E1|Reported Event|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
366130|NCT00713544|B7|Baseline|Total|Total of all reporting groups
366131|NCT00713544|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366132|NCT00713544|B5|Baseline|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366133|NCT00713544|B4|Baseline|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366134|NCT00713544|B3|Baseline|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366135|NCT00713544|B2|Baseline|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366136|NCT00713544|B1|Baseline|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366137|NCT00713544|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366138|NCT00713544|P5|Participant Flow|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366139|NCT00713544|P4|Participant Flow|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366140|NCT00713544|P3|Participant Flow|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366141|NCT00713544|P2|Participant Flow|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366142|NCT00713544|P1|Participant Flow|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366143|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366144|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366145|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366146|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366147|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366148|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366149|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366150|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366151|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366152|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366153|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366154|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366155|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366156|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366157|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366158|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366159|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366160|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366161|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366162|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366163|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366164|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366165|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366166|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366167|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366168|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366169|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
366170|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366171|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366172|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366173|NCT00713544|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
366174|NCT00713544|E5|Reported Event|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
366176|NCT00713544|E3|Reported Event|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
366177|NCT00713544|E2|Reported Event|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
366178|NCT00713544|E1|Reported Event|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
366179|NCT00713479|B1|Baseline|Total Sample|Includes only subjects who completed both components of the trial.
366180|NCT00713479|P2|Participant Flow|Varenicline, Then Placebo|Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
366181|NCT00713479|P1|Participant Flow|Placebo, Then Varenicline|Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
366182|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366183|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366184|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366185|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366186|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366187|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366188|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
366189|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366190|NCT00713479|E2|Reported Event|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
366191|NCT00713479|E1|Reported Event|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
366192|NCT00713349|B1|Baseline|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
366193|NCT00713349|P1|Participant Flow|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
366194|NCT00713349|O2|Outcome|Placebo Control|White Petrolatum : each subject acting as their own control
366195|NCT00713349|O1|Outcome|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
366196|NCT00713349|E2|Reported Event|Placebo Control|White Petrolatum : each subject acting as their own control
366197|NCT00713349|E1|Reported Event|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
366198|NCT00713323|B1|Baseline|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366238|NCT00713206|P2|Participant Flow|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
366199|NCT00713323|P1|Participant Flow|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366200|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366201|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366202|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366203|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366204|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366205|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366206|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366207|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366208|NCT00713323|E1|Reported Event|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
366209|NCT00713310|B3|Baseline|Total|Total of all reporting groups
366210|NCT00713310|B2|Baseline|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
366211|NCT00713310|B1|Baseline|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
366212|NCT00713310|P2|Participant Flow|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
366213|NCT00713310|P1|Participant Flow|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
366214|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366215|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366216|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366217|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366218|NCT00713310|E2|Reported Event|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366219|NCT00713310|E1|Reported Event|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
366220|NCT00713258|B3|Baseline|Total|Total of all reporting groups
366221|NCT00713258|B2|Baseline|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
366222|NCT00713258|B1|Baseline|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
366223|NCT00713258|P2|Participant Flow|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
366224|NCT00713258|P1|Participant Flow|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
366225|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
366226|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
366227|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
366228|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
366229|NCT00713258|E2|Reported Event|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
366230|NCT00713258|E1|Reported Event|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
366231|NCT00713219|B1|Baseline|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
366232|NCT00713219|P1|Participant Flow|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
366233|NCT00713219|O1|Outcome|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
366234|NCT00713219|E1|Reported Event|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
366235|NCT00713206|B3|Baseline|Total|Total of all reporting groups
366236|NCT00713206|B2|Baseline|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
366237|NCT00713206|B1|Baseline|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
366239|NCT00713206|P1|Participant Flow|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
366240|NCT00713206|O2|Outcome|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
366241|NCT00713206|O1|Outcome|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
366242|NCT00713206|E2|Reported Event|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
366243|NCT00713206|E1|Reported Event|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
366244|NCT00712985|B1|Baseline|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
366245|NCT00712985|P1|Participant Flow|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
366246|NCT00712985|O1|Outcome|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
366247|NCT00712985|E1|Reported Event|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
366248|NCT00712959|B3|Baseline|Total|Total of all reporting groups
366249|NCT00712959|B2|Baseline|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366250|NCT00712959|B1|Baseline|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366251|NCT00712959|P2|Participant Flow|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366252|NCT00712959|P1|Participant Flow|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
366253|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366254|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366255|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366256|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366257|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366258|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366259|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366260|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366261|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366262|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366263|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366264|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366265|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366266|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366267|NCT00712959|E2|Reported Event|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
366268|NCT00712959|E1|Reported Event|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
366269|NCT00712920|B4|Baseline|Total|Total of all reporting groups
366270|NCT00712920|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366271|NCT00712920|B2|Baseline|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366272|NCT00712920|B1|Baseline|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366273|NCT00712920|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366274|NCT00712920|P2|Participant Flow|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366275|NCT00712920|P1|Participant Flow|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366276|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366277|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366278|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366279|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366280|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366281|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366282|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366283|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366284|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366285|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366286|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366287|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366288|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366289|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366290|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366291|NCT00712920|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366292|NCT00712920|E2|Reported Event|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366293|NCT00712920|E1|Reported Event|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
366294|NCT00712725|B9|Baseline|Total|Total of all reporting groups
366295|NCT00712725|B8|Baseline|MK3207 200 mg|"MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366296|NCT00712725|B7|Baseline|MK3207 100 mg|"MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366297|NCT00712725|B6|Baseline|MK3207 50 mg|"MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366298|NCT00712725|B5|Baseline|MK3207 20 mg|"MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366299|NCT00712725|B4|Baseline|MK3207 10 mg|"MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366300|NCT00712725|B3|Baseline|MK3207 5 mg|"MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366301|NCT00712725|B2|Baseline|MK3207 2.5 mg|"MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366302|NCT00712725|B1|Baseline|Placebo|"Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
366303|NCT00712725|P8|Participant Flow|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366304|NCT00712725|P7|Participant Flow|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366305|NCT00712725|P6|Participant Flow|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366306|NCT00712725|P5|Participant Flow|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366307|NCT00712725|P4|Participant Flow|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366308|NCT00712725|P3|Participant Flow|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366309|NCT00712725|P2|Participant Flow|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366310|NCT00712725|P1|Participant Flow|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366311|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366312|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366313|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366314|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366315|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366316|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366317|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366318|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366319|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366320|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366321|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366322|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366323|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366324|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366325|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366326|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366327|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366328|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366329|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366330|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366331|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366332|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366333|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366334|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366335|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366336|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366337|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366338|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366339|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366340|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366341|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366342|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366343|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366344|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366345|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366346|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366347|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366348|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366349|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366350|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366351|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366352|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366353|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366354|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366355|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366356|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366357|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366358|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366359|NCT00712725|E8|Reported Event|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366360|NCT00712725|E7|Reported Event|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366361|NCT00712725|E6|Reported Event|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366362|NCT00712725|E5|Reported Event|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366363|NCT00712725|E4|Reported Event|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366364|NCT00712725|E3|Reported Event|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366365|NCT00712725|E2|Reported Event|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
366366|NCT00712725|E1|Reported Event|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
366367|NCT00712673|B4|Baseline|Total|Total of all reporting groups
366368|NCT00712673|B3|Baseline|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366417|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366369|NCT00712673|B2|Baseline|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366370|NCT00712673|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366371|NCT00712673|P4|Participant Flow|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366372|NCT00712673|P3|Participant Flow|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366373|NCT00712673|P2|Participant Flow|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366374|NCT00712673|P1|Participant Flow|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
366375|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366376|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366377|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366378|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366379|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366380|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366381|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366382|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366383|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366384|NCT00712673|O6|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of lixisenatide.
366385|NCT00712673|O5|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366386|NCT00712673|O4|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366387|NCT00712673|O3|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
366388|NCT00712673|O2|Outcome|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
366389|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
366390|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366391|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366392|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
366393|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366394|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366395|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366396|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366397|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366398|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366399|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366400|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366401|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366402|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366403|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366404|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366405|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366406|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366407|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366408|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366409|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366410|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366411|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366412|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366413|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366414|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366415|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366416|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
367078|NCT00711100|O4|Outcome|Ariva|Number of particpants that sampled Ariva
366418|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366419|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366420|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366421|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366422|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
366423|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366424|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366425|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366426|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366427|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366428|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366429|NCT00712673|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.
366430|NCT00712673|E5|Reported Event|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
366431|NCT00712673|E4|Reported Event|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
366432|NCT00712673|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
366433|NCT00712673|E2|Reported Event|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
366434|NCT00712673|E1|Reported Event|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
366435|NCT00712543|B3|Baseline|Total|Total of all reporting groups
366436|NCT00712543|B2|Baseline|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
366437|NCT00712543|B1|Baseline|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
366438|NCT00712543|P2|Participant Flow|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
366439|NCT00712543|P1|Participant Flow|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
366440|NCT00712543|O2|Outcome|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
366441|NCT00712543|O1|Outcome|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
366442|NCT00712543|E2|Reported Event|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
366443|NCT00712543|E1|Reported Event|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
366444|NCT00712530|B4|Baseline|Total|Total of all reporting groups
366445|NCT00712530|B3|Baseline|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366446|NCT00712530|B2|Baseline|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366447|NCT00712530|B1|Baseline|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366448|NCT00712530|P3|Participant Flow|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366449|NCT00712530|P2|Participant Flow|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366450|NCT00712530|P1|Participant Flow|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366451|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366452|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366453|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366454|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366455|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366989|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366456|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366457|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366458|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366459|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366460|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366461|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366462|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366463|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366464|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366465|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366466|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366467|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366468|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366469|NCT00712530|E3|Reported Event|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
366470|NCT00712530|E2|Reported Event|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
366471|NCT00712530|E1|Reported Event|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
366472|NCT00712348|B1|Baseline|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366473|NCT00712348|P1|Participant Flow|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366474|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366475|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366476|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366477|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366478|NCT00712348|E1|Reported Event|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
366479|NCT00712335|B6|Baseline|Total|Total of all reporting groups
366480|NCT00712335|B5|Baseline|Normal Controls|Normal controls did not receive any treatment.
366481|NCT00712335|B4|Baseline|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366482|NCT00712335|B3|Baseline|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366483|NCT00712335|B2|Baseline|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366484|NCT00712335|B1|Baseline|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366485|NCT00712335|P5|Participant Flow|Normal Controls|Normal controls did not receive any treatment.
366486|NCT00712335|P4|Participant Flow|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366487|NCT00712335|P3|Participant Flow|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366488|NCT00712335|P2|Participant Flow|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
367079|NCT00711100|O3|Outcome|Stonewall|Number of particpants that sampled Stonewall
366489|NCT00712335|P1|Participant Flow|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366490|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366491|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366492|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366493|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366494|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366495|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366496|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366497|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366498|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366499|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366500|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366501|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366502|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366503|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366504|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366505|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366506|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366507|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366508|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366509|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366510|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366511|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366512|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366513|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366514|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366515|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366516|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366517|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366518|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366519|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366520|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
366521|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366522|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366523|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366524|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366525|NCT00712335|E5|Reported Event|Normal Controls|Normal controls did not receive any treatment.
366526|NCT00712335|E4|Reported Event|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366527|NCT00712335|E3|Reported Event|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366528|NCT00712335|E2|Reported Event|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
366529|NCT00712335|E1|Reported Event|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
366530|NCT00712244|B5|Baseline|Total|Total of all reporting groups
366531|NCT00712244|B4|Baseline|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366532|NCT00712244|B3|Baseline|Healon5|Healon5 Ophthalmic Viscosurgical Device
366533|NCT00712244|B2|Baseline|DUOVISC|DUOVISC® Viscoelastic system
366534|NCT00712244|B1|Baseline|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366535|NCT00712244|P4|Participant Flow|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366536|NCT00712244|P3|Participant Flow|Healon5|Healon5 Ophthalmic Viscosurgical Device
366537|NCT00712244|P2|Participant Flow|DUOVISC|DUOVISC® Viscoelastic system
366538|NCT00712244|P1|Participant Flow|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366539|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366540|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366541|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366542|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366543|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366544|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366545|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366546|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366547|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366548|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366549|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366550|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366551|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366552|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366553|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366554|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366555|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366556|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366557|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366558|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366559|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366560|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366561|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366562|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366563|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366564|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366565|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366566|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366567|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366568|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366569|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366570|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366571|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366572|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
366573|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
366574|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366575|NCT00712244|E4|Reported Event|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
366576|NCT00712244|E3|Reported Event|Healon5|Healon5 Ophthalmic Viscosurgical Device
366577|NCT00712244|E2|Reported Event|DUOVISC|DUOVISC® Viscoelastic system
366578|NCT00712244|E1|Reported Event|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
366579|NCT00712179|B1|Baseline|Stroke Survivors|Cross-sectional study with a single group of stroke survivors
366580|NCT00712179|P1|Participant Flow|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
366581|NCT00712179|O1|Outcome|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
366582|NCT00712179|E1|Reported Event|Stroke Survivors|Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
366583|NCT00712166|B3|Baseline|Total|Total of all reporting groups
366584|NCT00712166|B2|Baseline|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366585|NCT00712166|B1|Baseline|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366647|NCT00712010|E5|Reported Event|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366586|NCT00712166|P2|Participant Flow|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366587|NCT00712166|P1|Participant Flow|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366588|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366589|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366590|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366591|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366592|NCT00712166|O2|Outcome|AZLI 75 mg TID|"AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 76"
366593|NCT00712166|O1|Outcome|Placebo TID|"Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 108"
366594|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366595|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366596|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366597|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366598|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366599|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366600|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366601|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366602|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366603|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366604|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366605|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366606|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366607|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366608|NCT00712166|E2|Reported Event|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
366609|NCT00712166|E1|Reported Event|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
366610|NCT00712075|B4|Baseline|Total|Total of all reporting groups
366648|NCT00712010|E4|Reported Event|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366611|NCT00712075|B3|Baseline|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366612|NCT00712075|B2|Baseline|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366613|NCT00712075|B1|Baseline|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366614|NCT00712075|P3|Participant Flow|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366615|NCT00712075|P2|Participant Flow|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366616|NCT00712075|P1|Participant Flow|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366617|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366618|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366619|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366620|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366621|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366622|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366649|NCT00712010|E3|Reported Event|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366623|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366624|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366625|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366626|NCT00712075|E3|Reported Event|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
366627|NCT00712075|E2|Reported Event|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
366628|NCT00712075|E1|Reported Event|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
366629|NCT00712010|B1|Baseline|Entire Study Population|Includes groups randomized to receive 7 products in a randomized series
366630|NCT00712010|P1|Participant Flow|7 Proteins Were Tested Randomly|"Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:~intact whey protein~whey protein micelles~exhaustively hydrolyzed whey protein~intact casein protein~exhaustively hydrolyzed casein protein~total milk protein~exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein."
366631|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366632|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366633|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366634|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366635|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366636|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366637|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366638|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366639|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366640|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366641|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366642|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366643|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366644|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366645|NCT00712010|E7|Reported Event|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366646|NCT00712010|E6|Reported Event|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366650|NCT00712010|E2|Reported Event|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366651|NCT00712010|E1|Reported Event|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
366652|NCT00711997|B3|Baseline|Total|Total of all reporting groups
366653|NCT00711997|B2|Baseline|BC-819 8 mg|
366654|NCT00711997|B1|Baseline|BC-819 4 mg|
366655|NCT00711997|P2|Participant Flow|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
366656|NCT00711997|P1|Participant Flow|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
366657|NCT00711997|O2|Outcome|BC-819 8 mg|2 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
366658|NCT00711997|O1|Outcome|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
366659|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
366660|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
366661|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
366662|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
366663|NCT00711997|E2|Reported Event|BC-819 8 mg|2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
366664|NCT00711997|E1|Reported Event|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
366665|NCT00711880|B3|Baseline|Total|Total of all reporting groups
366666|NCT00711880|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366667|NCT00711880|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366668|NCT00711880|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366669|NCT00711880|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366670|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366671|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366672|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366673|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366674|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366675|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366676|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366677|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366678|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366679|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366680|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366681|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366682|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366683|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366684|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366754|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366685|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366686|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366687|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366688|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366689|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366690|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366691|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366692|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366693|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366694|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366695|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366696|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366697|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366698|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366699|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366700|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366701|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366702|NCT00711880|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366703|NCT00711880|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366704|NCT00711867|B3|Baseline|Total|Total of all reporting groups
366705|NCT00711867|B2|Baseline|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
366706|NCT00711867|B1|Baseline|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
366707|NCT00711867|P2|Participant Flow|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
366708|NCT00711867|P1|Participant Flow|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
366709|NCT00711867|O2|Outcome|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
366710|NCT00711867|O1|Outcome|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
366711|NCT00711867|E2|Reported Event|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
366712|NCT00711867|E1|Reported Event|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
366713|NCT00711828|B1|Baseline|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
366714|NCT00711828|P1|Participant Flow|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
366715|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366716|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366717|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366718|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366719|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366720|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
366721|NCT00711828|E1|Reported Event|Treatment|Dexamethasone 40 mg PO on days 1, 8, 15, 22
366722|NCT00711802|B9|Baseline|Total|Total of all reporting groups
366723|NCT00711802|B8|Baseline|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
366724|NCT00711802|B7|Baseline|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366725|NCT00711802|B6|Baseline|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
366726|NCT00711802|B5|Baseline|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366727|NCT00711802|B4|Baseline|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
366728|NCT00711802|B3|Baseline|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366729|NCT00711802|B2|Baseline|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
366730|NCT00711802|B1|Baseline|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366731|NCT00711802|P8|Participant Flow|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
366732|NCT00711802|P7|Participant Flow|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366733|NCT00711802|P6|Participant Flow|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
366734|NCT00711802|P5|Participant Flow|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366735|NCT00711802|P4|Participant Flow|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
366736|NCT00711802|P3|Participant Flow|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366737|NCT00711802|P2|Participant Flow|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
366738|NCT00711802|P1|Participant Flow|Age Group 1: Daptomycin|"Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366739|NCT00711802|O4|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366740|NCT00711802|O3|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366741|NCT00711802|O2|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366742|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366743|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
366744|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366745|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
366746|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366747|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
366748|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366749|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
366750|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366751|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
366752|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366753|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
366755|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
366756|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366757|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
366758|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366759|NCT00711802|E8|Reported Event|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
366760|NCT00711802|E7|Reported Event|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
366761|NCT00711802|E6|Reported Event|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
366762|NCT00711802|E5|Reported Event|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
366763|NCT00711802|E4|Reported Event|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
366764|NCT00711802|E3|Reported Event|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
366765|NCT00711802|E2|Reported Event|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
366766|NCT00711802|E1|Reported Event|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
366767|NCT00711646|B3|Baseline|Total|Total of all reporting groups
366768|NCT00711646|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366769|NCT00711646|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366770|NCT00711646|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366771|NCT00711646|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366772|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366773|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366774|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366775|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366776|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366777|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366778|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366779|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366780|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366781|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366782|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366783|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366784|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
366785|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366786|NCT00711646|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
367080|NCT00711100|O2|Outcome|Marlboro Snus|Number of particpants that sampled Marlboro Snus
366787|NCT00711646|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
366788|NCT00711594|B5|Baseline|Total|Total of all reporting groups
366789|NCT00711594|B4|Baseline|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366790|NCT00711594|B3|Baseline|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366791|NCT00711594|B2|Baseline|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366792|NCT00711594|B1|Baseline|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366793|NCT00711594|P4|Participant Flow|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366794|NCT00711594|P3|Participant Flow|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366795|NCT00711594|P2|Participant Flow|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366796|NCT00711594|P1|Participant Flow|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366797|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366798|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366799|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366800|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366801|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366802|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366803|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
366804|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366805|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366806|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
366807|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366808|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366809|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
366810|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366811|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366812|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366813|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366814|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366815|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366816|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366817|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366818|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366819|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366820|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366821|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366822|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366823|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366824|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366825|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366826|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366827|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366828|NCT00711594|E4|Reported Event|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366829|NCT00711594|E3|Reported Event|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
366830|NCT00711594|E2|Reported Event|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
366831|NCT00711594|E1|Reported Event|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
366832|NCT00711555|B1|Baseline|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366833|NCT00711555|P1|Participant Flow|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366834|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366835|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366836|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366837|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366838|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
366839|NCT00711529|B3|Baseline|Total|Total of all reporting groups
366840|NCT00711529|B2|Baseline|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366841|NCT00711529|B1|Baseline|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366842|NCT00711529|P2|Participant Flow|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366843|NCT00711529|P1|Participant Flow|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366844|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366845|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366846|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366847|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366848|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366849|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366850|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366851|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366852|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366853|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366854|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366855|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366856|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366857|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366858|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366859|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366860|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366861|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366862|NCT00711529|E2|Reported Event|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
366863|NCT00711529|E1|Reported Event|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
366864|NCT00711516|B3|Baseline|Total|Total of all reporting groups
366865|NCT00711516|B2|Baseline|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366866|NCT00711516|B1|Baseline|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366867|NCT00711516|P2|Participant Flow|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366868|NCT00711516|P1|Participant Flow|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366869|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366870|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366871|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366872|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366873|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366874|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366875|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366876|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366877|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366878|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366879|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366880|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366881|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366882|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366883|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366884|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366885|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366886|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366887|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366888|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366889|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366890|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366984|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367081|NCT00711100|O1|Outcome|Camel Snus|Number of participants that sampled
366891|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366892|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366893|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366894|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366895|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366896|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366897|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366898|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366899|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366900|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366901|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366902|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366903|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366904|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366905|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366906|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366907|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366908|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366909|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366910|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366985|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367082|NCT00711100|O5|Outcome|General Snus|Number of particpants that sampled General Snus
366911|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366912|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366913|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366914|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366915|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366916|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366917|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366918|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366919|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366920|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366921|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366922|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366923|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366924|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366925|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366926|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366927|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366928|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366929|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366930|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366986|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366987|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366931|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366932|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366933|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366934|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366935|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366936|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366937|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366938|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366939|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366940|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366941|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366942|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366943|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366944|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366945|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366946|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366947|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366948|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366949|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366950|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366988|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367083|NCT00711100|O4|Outcome|Ariva|Number of particpants that sampled Ariva
366951|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366952|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366953|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366954|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366955|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366956|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366957|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366958|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
366959|NCT00711516|E2|Reported Event|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366960|NCT00711516|E1|Reported Event|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
366961|NCT00711490|B1|Baseline|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
366962|NCT00711490|P1|Participant Flow|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
366963|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
366964|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
366965|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
366966|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
366967|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
366968|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
366969|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
366970|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
366971|NCT00711490|E1|Reported Event|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
366972|NCT00711477|B3|Baseline|Total|Total of all reporting groups
366973|NCT00711477|B2|Baseline|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366974|NCT00711477|B1|Baseline|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366975|NCT00711477|P2|Participant Flow|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366976|NCT00711477|P1|Participant Flow|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366977|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366978|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366979|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366980|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366981|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366982|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366983|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367084|NCT00711100|O3|Outcome|Stonewall|Number of particpants that sampled Stonewall
366990|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366991|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366992|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366993|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366994|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366995|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366996|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366997|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366998|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
366999|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367000|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367001|NCT00711477|E2|Reported Event|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367002|NCT00711477|E1|Reported Event|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
367003|NCT00711425|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367004|NCT00711425|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367005|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367006|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367007|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367008|NCT00711425|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367009|NCT00711347|B3|Baseline|Total|Total of all reporting groups
367010|NCT00711347|B2|Baseline|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367011|NCT00711347|B1|Baseline|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367012|NCT00711347|P2|Participant Flow|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367013|NCT00711347|P1|Participant Flow|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367014|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367015|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367016|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367017|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367018|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367019|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367020|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367021|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367022|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367023|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367024|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367025|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367026|NCT00711347|E2|Reported Event|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
367027|NCT00711347|E1|Reported Event|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
367028|NCT00711191|B4|Baseline|Total|Total of all reporting groups
367029|NCT00711191|B3|Baseline|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367030|NCT00711191|B2|Baseline|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367031|NCT00711191|B1|Baseline|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367045|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367032|NCT00711191|P3|Participant Flow|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367033|NCT00711191|P2|Participant Flow|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367034|NCT00711191|P1|Participant Flow|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367035|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|"Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.~Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.~Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles."
367036|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367037|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367038|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367039|NCT00711191|O1|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367040|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367041|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367042|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367043|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367044|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367046|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367047|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367048|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367049|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367050|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367051|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367052|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367053|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367054|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367055|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367056|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367057|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367058|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367076|NCT00711100|B1|Baseline|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
367077|NCT00711100|P1|Participant Flow|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
372753|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
367059|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367060|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367061|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367062|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367063|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367064|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367065|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367066|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367067|NCT00711191|E3|Reported Event|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
367068|NCT00711191|E2|Reported Event|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
367069|NCT00711191|E1|Reported Event|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
367070|NCT00711113|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367071|NCT00711113|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367072|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367073|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367074|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367075|NCT00711113|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
367085|NCT00711100|O2|Outcome|Marlboro Snus|Number of particpants that sampled Marlboro Snus
367086|NCT00711100|O1|Outcome|Camel Snus|Number of participants that sampled
367087|NCT00711100|E5|Reported Event|General Snus|Participants that sampled General Snus
367088|NCT00711100|E4|Reported Event|Ariva|Participants that sampled Ariva
367089|NCT00711100|E3|Reported Event|Stonewall|Participants that sampled Stonewall
367090|NCT00711100|E2|Reported Event|Marlboro Snus|Participants that sampled Marlboro Snus
367091|NCT00711100|E1|Reported Event|Camel Snus|Particpants that sampled Camel Snus
367092|NCT00711087|B3|Baseline|Total|Total of all reporting groups
367093|NCT00711087|B2|Baseline|ARM 1|Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
367094|NCT00711087|B1|Baseline|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
367095|NCT00711087|P2|Participant Flow|ARM 1|Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
367096|NCT00711087|P1|Participant Flow|ARM 2|Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
367097|NCT00711087|O2|Outcome|ARM 1|Subjects randomized to receive 100 units of BOTOX-A on Days 0 and 90
367098|NCT00711087|O1|Outcome|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
367099|NCT00711087|E2|Reported Event|ARM 1|"Receiving BOTOX-A~BOTOX-A: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90"
367100|NCT00711087|E1|Reported Event|ARM 2|"Receiving placebo (saline injections)~Saline injection: Group 2-sham saline injections on both Day 0 and Day 90."
367101|NCT00711022|B1|Baseline|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
367102|NCT00711022|P1|Participant Flow|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
367103|NCT00711022|O1|Outcome|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
367104|NCT00711022|E1|Reported Event|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
367105|NCT00711009|B3|Baseline|Total|Total of all reporting groups
367106|NCT00711009|B2|Baseline|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367107|NCT00711009|B1|Baseline|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367108|NCT00711009|P2|Participant Flow|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367109|NCT00711009|P1|Participant Flow|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367110|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367111|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367112|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367113|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367114|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367115|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367116|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367117|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367118|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367119|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367120|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367121|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367122|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367123|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367124|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367125|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367126|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367127|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367128|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367129|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367130|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367131|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367132|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367133|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367134|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367135|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367136|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367137|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367138|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367139|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367140|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367141|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367142|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367143|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367144|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367145|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367146|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367147|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367148|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367149|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367150|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367151|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367152|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367153|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367154|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367155|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367156|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367157|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367158|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367159|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367160|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367161|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367162|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367163|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367164|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367165|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367166|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367167|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367168|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367169|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367170|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367171|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367172|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367173|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367174|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367175|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367176|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367177|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367178|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367179|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367180|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367181|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367182|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367183|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367184|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367185|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367186|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367187|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367188|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367189|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367190|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367191|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367192|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367193|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367194|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367195|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367196|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367197|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367198|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367199|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367200|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367201|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367202|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367203|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367204|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367205|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367206|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367207|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367208|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367209|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367210|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367211|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367212|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367213|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367214|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367215|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367216|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367217|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367218|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367219|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367220|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367221|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367222|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367223|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367224|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367225|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367226|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367227|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367228|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367229|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367230|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367231|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367232|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367233|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367234|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367235|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367236|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367237|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367238|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367239|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367240|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367241|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367242|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367243|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367244|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367245|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367246|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367247|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367248|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367249|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367250|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367251|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367252|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367253|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367254|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367255|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367256|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367257|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367258|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367259|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367260|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367261|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367262|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367263|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367264|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367265|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367266|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367267|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367268|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367269|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367270|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367271|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367272|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367273|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367274|NCT00711009|E2|Reported Event|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
367275|NCT00711009|E1|Reported Event|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
367276|NCT00710996|B4|Baseline|Total|Total of all reporting groups
367277|NCT00710996|B3|Baseline|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
367278|NCT00710996|B2|Baseline|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
367279|NCT00710996|B1|Baseline|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
367280|NCT00710996|P3|Participant Flow|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
367281|NCT00710996|P2|Participant Flow|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
367282|NCT00710996|P1|Participant Flow|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
367283|NCT00710996|O3|Outcome|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
367284|NCT00710996|O2|Outcome|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
367285|NCT00710996|O1|Outcome|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
367286|NCT00710996|E3|Reported Event|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
367287|NCT00710996|E2|Reported Event|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
367288|NCT00710996|E1|Reported Event|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
367289|NCT00710970|B1|Baseline|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
367290|NCT00710970|P1|Participant Flow|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
367291|NCT00710970|O1|Outcome|Single Arm Receiving 20 mg Tamoxifen|
367292|NCT00710970|E1|Reported Event|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
367293|NCT00710944|B4|Baseline|Total|Total of all reporting groups
367294|NCT00710944|B3|Baseline|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367295|NCT00710944|B2|Baseline|Healed Ridges|"Immediate loading of implants placed in healed ridges.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367296|NCT00710944|B1|Baseline|Extraction Sockets|"Immediate loading of implants placed in extraction sockets.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367297|NCT00710944|P3|Participant Flow|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367298|NCT00710944|P2|Participant Flow|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367299|NCT00710944|P1|Participant Flow|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367300|NCT00710944|O3|Outcome|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367301|NCT00710944|O2|Outcome|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367302|NCT00710944|O1|Outcome|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367303|NCT00710944|E3|Reported Event|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
367345|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367304|NCT00710944|E2|Reported Event|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367305|NCT00710944|E1|Reported Event|Extractions Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
367306|NCT00710931|B1|Baseline|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
367307|NCT00710931|P1|Participant Flow|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
367308|NCT00710931|O1|Outcome|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
367309|NCT00710931|E1|Reported Event|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
367310|NCT00710905|B1|Baseline|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
367311|NCT00710905|P1|Participant Flow|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
367312|NCT00710905|O1|Outcome|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
367313|NCT00710905|E1|Reported Event|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
367314|NCT00710879|B3|Baseline|Total|Total of all reporting groups
367315|NCT00710879|B2|Baseline|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367316|NCT00710879|B1|Baseline|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367317|NCT00710879|P2|Participant Flow|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367318|NCT00710879|P1|Participant Flow|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367319|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367320|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367321|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367322|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367323|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367324|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367325|NCT00710879|E2|Reported Event|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
367326|NCT00710879|E1|Reported Event|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
367327|NCT00710866|B3|Baseline|Total|Total of all reporting groups
367328|NCT00710866|B2|Baseline|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367329|NCT00710866|B1|Baseline|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367330|NCT00710866|P2|Participant Flow|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367331|NCT00710866|P1|Participant Flow|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367332|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367333|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367334|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367335|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367336|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367337|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367338|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367339|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367340|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367341|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367342|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367343|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367344|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367346|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367347|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367348|NCT00710866|E2|Reported Event|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
367349|NCT00710866|E1|Reported Event|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
367350|NCT00710840|B3|Baseline|Total|Total of all reporting groups
367351|NCT00710840|B2|Baseline|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367352|NCT00710840|B1|Baseline|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367353|NCT00710840|P2|Participant Flow|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367354|NCT00710840|P1|Participant Flow|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367355|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367356|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367357|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367358|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367359|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367360|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367361|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367362|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367363|NCT00710840|E2|Reported Event|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
367364|NCT00710840|E1|Reported Event|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
367365|NCT00710814|B3|Baseline|Total|Total of all reporting groups
367366|NCT00710814|B2|Baseline|Placebo - Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
367367|NCT00710814|B1|Baseline|Leptin - Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
367368|NCT00710814|P2|Participant Flow|Placebo-Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
367369|NCT00710814|P1|Participant Flow|Leptin-Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
367370|NCT00710814|O2|Outcome|Placebo Intervention|"Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
367420|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
373105|NCT00699608|O1|Outcome|Placebo|Placebo
367371|NCT00710814|O1|Outcome|Leptin Intervention|"Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
367372|NCT00710814|E2|Reported Event|Placebo Intervention|"This group Placebo Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only."
367373|NCT00710814|E1|Reported Event|Leptin Intervention|"This group Leptin Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only."
367374|NCT00710762|B3|Baseline|Total|Total of all reporting groups
367375|NCT00710762|B2|Baseline|Placebo|Patients were treated with matching placebo twice daily
367376|NCT00710762|B1|Baseline|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367377|NCT00710762|P2|Participant Flow|Placebo|Patients were treated with matching placebo twice daily
367378|NCT00710762|P1|Participant Flow|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367379|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367380|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367381|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367382|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367383|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367384|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367385|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367386|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367387|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367388|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367389|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
367390|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
367391|NCT00710762|E2|Reported Event|Placebo|Patients were treated with matching placebo twice daily.
367392|NCT00710762|E1|Reported Event|Nintedanib|Patients were treated with 250mg nintedanib twice daily.
367393|NCT00710749|B1|Baseline|Entire Study Population|Includes groups randomized to use the Disposable device first and the Digital device first.
367394|NCT00710749|P2|Participant Flow|Digital Device First, Then Disposable Device|12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
367395|NCT00710749|P1|Participant Flow|Disposable Device First, Then Digital Device|12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.
367396|NCT00710749|O3|Outcome|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
367397|NCT00710749|O2|Outcome|Clinic|Voidings recorded with the clinic gold standard.
367398|NCT00710749|O1|Outcome|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
367399|NCT00710749|E3|Reported Event|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
367400|NCT00710749|E2|Reported Event|Clinic|Voidings recorded with the clinic gold standard.
367401|NCT00710749|E1|Reported Event|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
367402|NCT00710606|B3|Baseline|Total|Total of all reporting groups
367403|NCT00710606|B2|Baseline|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
367404|NCT00710606|B1|Baseline|Obese Subjects|Obese subjects (BMI 30-39.9)
367405|NCT00710606|P2|Participant Flow|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
367406|NCT00710606|P1|Participant Flow|Obese Subjects|Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
367407|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
367408|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
367409|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
367410|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
367411|NCT00710606|O2|Outcome|Obese|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
367412|NCT00710606|O1|Outcome|Normal Weight|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
367413|NCT00710606|E2|Reported Event|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
367414|NCT00710606|E1|Reported Event|Obese Subjects|Obese subjects (BMI 30-39.9)
367415|NCT00710554|B3|Baseline|Total|Total of all reporting groups
367416|NCT00710554|B2|Baseline|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367417|NCT00710554|B1|Baseline|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367418|NCT00710554|P2|Participant Flow|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367419|NCT00710554|P1|Participant Flow|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367421|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367422|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367423|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367424|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367425|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367426|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367427|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367428|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367429|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367430|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367431|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367432|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367433|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367434|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367435|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367436|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367437|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367438|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367439|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367440|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367441|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367442|NCT00710554|E2|Reported Event|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
367443|NCT00710554|E1|Reported Event|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
367444|NCT00710424|B3|Baseline|Total|Total of all reporting groups
367445|NCT00710424|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367446|NCT00710424|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367447|NCT00710424|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367448|NCT00710424|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367449|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367450|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367451|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367452|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367453|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367454|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367455|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367456|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367457|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367458|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367459|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367460|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367461|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367462|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367463|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367464|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367465|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367466|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367467|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367468|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367469|NCT00710424|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
367470|NCT00710424|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
367471|NCT00710385|B1|Baseline|Challenge Doses|This study employs a within-subjects design, all participant experience all challenge doses.
367472|NCT00710385|P1|Participant Flow|Intravenous Challenge Doses|This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
367473|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
367474|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
367475|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
367476|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
367477|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
367478|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
367479|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
367480|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
367481|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
367482|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
367483|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
367484|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
367485|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
367486|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
367487|NCT00710385|E1|Reported Event|Combined for All Study Conditions|This study employed a within-subjects design, all participants experienced all study conditions.
367488|NCT00710203|B1|Baseline|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
367489|NCT00710203|P1|Participant Flow|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
367490|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367491|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367492|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367493|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367494|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367495|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367496|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367497|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367498|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367499|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367500|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367501|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367502|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367503|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367504|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367505|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367506|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367507|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367508|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367509|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367510|NCT00710203|E4|Reported Event|No Treatment|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
367511|NCT00710203|E3|Reported Event|Electrodesiccation|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
367512|NCT00710203|E2|Reported Event|Curettage|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
367513|NCT00710203|E1|Reported Event|Pulsed Dye Laser|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
367514|NCT00710021|B4|Baseline|Total|Total of all reporting groups
367515|NCT00710021|B3|Baseline|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367516|NCT00710021|B2|Baseline|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367517|NCT00710021|B1|Baseline|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367518|NCT00710021|P3|Participant Flow|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367519|NCT00710021|P2|Participant Flow|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367520|NCT00710021|P1|Participant Flow|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367521|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367522|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367523|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367524|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367525|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367526|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367527|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367528|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367529|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367530|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367531|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367532|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367533|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367534|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367535|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367536|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367537|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367538|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367539|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367540|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367541|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367542|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367543|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367544|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367545|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367546|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367547|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367548|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367549|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367550|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367551|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367552|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367553|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367554|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367555|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367556|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367557|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367558|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367559|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367560|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367561|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367562|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367563|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367564|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367565|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367566|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367567|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367568|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367569|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367648|NCT00709878|B5|Baseline|Total|Total of all reporting groups
367570|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367571|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367572|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367573|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367574|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367575|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367576|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367577|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367578|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367579|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367580|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367581|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367582|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367583|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367584|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367585|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367586|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367587|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367588|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367589|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367590|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367591|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367592|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367593|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367594|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367595|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367596|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367597|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367598|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367599|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367600|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367601|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367602|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367603|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367604|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367605|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367606|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367607|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367608|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367609|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367610|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367611|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367612|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367613|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367614|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367615|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367616|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367617|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367618|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367619|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367620|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367621|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367622|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367623|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367624|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367625|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
367626|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367627|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367628|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367629|NCT00710021|E3|Reported Event|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
367630|NCT00710021|E2|Reported Event|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
367631|NCT00710021|E1|Reported Event|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
367632|NCT00709956|B3|Baseline|Total|Total of all reporting groups
367633|NCT00709956|B2|Baseline|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
367634|NCT00709956|B1|Baseline|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
367635|NCT00709956|P2|Participant Flow|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
367636|NCT00709956|P1|Participant Flow|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
367637|NCT00709956|O2|Outcome|Borg Dyspnea Score After Iloprost (5 µg) Treatment|
367638|NCT00709956|O1|Outcome|Borg Dyspnea Score After Placebo Treatment|
367639|NCT00709956|O2|Outcome|6MWD After Iloprost (5 µg) Treatment|
367640|NCT00709956|O1|Outcome|6MWD After Placebo Treatment|
367641|NCT00709956|E2|Reported Event|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
367642|NCT00709956|E1|Reported Event|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
367643|NCT00709891|B1|Baseline|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
367644|NCT00709891|P1|Participant Flow|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
367645|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
367646|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
367647|NCT00709891|E1|Reported Event|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
367649|NCT00709878|B4|Baseline|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
367650|NCT00709878|B3|Baseline|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
367651|NCT00709878|B2|Baseline|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
367652|NCT00709878|B1|Baseline|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
367653|NCT00709878|P4|Participant Flow|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
367654|NCT00709878|P3|Participant Flow|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
367655|NCT00709878|P2|Participant Flow|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
367656|NCT00709878|P1|Participant Flow|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
367657|NCT00709878|O4|Outcome|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
367658|NCT00709878|O3|Outcome|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
367659|NCT00709878|O2|Outcome|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
367660|NCT00709878|O1|Outcome|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
367661|NCT00709878|E4|Reported Event|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
367662|NCT00709878|E3|Reported Event|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
367663|NCT00709878|E2|Reported Event|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
367664|NCT00709878|E1|Reported Event|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
367665|NCT00709852|B1|Baseline|Entire Study Population|Includes participants who received either treatment
367666|NCT00709852|P2|Participant Flow|Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
367667|NCT00709852|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
367668|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367669|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367670|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367671|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367672|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367673|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367674|NCT00709852|O1|Outcome|Combined Gadobutrol vs. Combined Gadoteridol|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367675|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367676|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367677|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367678|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367679|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367680|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367681|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367682|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367683|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367684|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367685|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367686|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367687|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367688|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367689|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367690|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367691|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367692|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367693|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367694|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367695|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367696|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367697|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367698|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367699|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367700|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367701|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367702|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367703|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367704|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367705|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367706|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367707|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367708|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367709|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367710|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367711|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367712|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367713|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367714|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367715|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367716|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367717|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367718|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367719|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367720|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367721|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367722|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367723|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367724|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367725|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367726|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367727|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367728|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367729|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367730|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367731|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367732|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367733|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367734|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367735|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367736|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367737|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367738|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367739|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367740|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367741|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367742|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367743|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367744|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367745|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367746|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367747|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367748|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367749|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367750|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367751|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367752|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367753|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367754|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367755|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367756|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367757|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367758|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367759|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367760|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367761|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367762|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367763|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367764|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367765|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367766|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367767|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367768|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367769|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367770|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367771|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367772|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367773|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367774|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367775|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367776|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367777|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Gadobutrol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
367778|NCT00709852|O1|Outcome|Gadobutrol-enhanced Compared to Gadoteridol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
367823|NCT00709826|P1|Participant Flow|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
373106|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
367779|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Unenhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
367780|NCT00709852|O1|Outcome|Unenhanced Compared to Gadoteridol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
367781|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
367782|NCT00709852|O1|Outcome|Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
367783|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367784|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367785|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367786|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
367787|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367788|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367789|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367790|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367791|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367792|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367793|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367794|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367795|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367796|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367797|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367798|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367799|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367800|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367801|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367802|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367803|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367804|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367805|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367806|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367807|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367808|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367809|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367810|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367811|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367812|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367813|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367814|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367815|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367816|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
367817|NCT00709852|E2|Reported Event|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
367818|NCT00709852|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
367819|NCT00709826|B3|Baseline|Total|Total of all reporting groups
367820|NCT00709826|B2|Baseline|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
367821|NCT00709826|B1|Baseline|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
367822|NCT00709826|P2|Participant Flow|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
367824|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
367825|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
367826|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
367827|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
367828|NCT00709826|E2|Reported Event|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
367829|NCT00709826|E1|Reported Event|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
367830|NCT00708734|B1|Baseline|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 5 weeks"
367831|NCT00708734|P1|Participant Flow|Arm 1|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
367832|NCT00708734|O1|Outcome|Composite Measures of Gait and Balance|Measurement of gait and balance using standardized tools
367833|NCT00708734|E1|Reported Event|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
367834|NCT00708708|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367835|NCT00708708|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367836|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367837|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367838|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367839|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367840|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367841|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367902|NCT00708643|B2|Baseline|Narafilcon A|Silicone hydrogel daily disposable contact lens
373107|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
367842|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367843|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367844|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367845|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367846|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367847|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367848|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367849|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367850|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367851|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
367852|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
367853|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
367854|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
367855|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
367856|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
367857|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367858|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367859|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367860|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367861|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367862|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367863|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367864|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367865|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367866|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367867|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367868|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367869|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367870|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367871|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367872|NCT00708708|O3|Outcome|Remaining Participants|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
367873|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
367874|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
367875|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367876|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367877|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367878|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367879|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367880|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367881|NCT00708708|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
367882|NCT00708682|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367883|NCT00708682|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367884|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367885|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367886|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367887|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367888|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367889|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367890|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367891|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367892|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367893|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367894|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367895|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367896|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367897|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
367898|NCT00708682|E3|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96."
367899|NCT00708682|E2|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
367900|NCT00708682|E1|Reported Event|Infant Series 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).~Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively."
367901|NCT00708643|B3|Baseline|Total|Total of all reporting groups
367903|NCT00708643|B1|Baseline|Habitual Silicone Hydrogel|Habitual contact lens wear.
367904|NCT00708643|P2|Participant Flow|Narafilcon A|Silicone hydrogel daily disposable contact lens
367905|NCT00708643|P1|Participant Flow|Habitual Silicone Hydrogel|Habitual contact lens wear.
367906|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367907|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367908|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367909|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367910|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367911|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367912|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367913|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367914|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367915|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367916|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
367917|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
367918|NCT00708643|E2|Reported Event|Narafilcon A|Silicone hydrogel daily disposable contact lens
367919|NCT00708643|E1|Reported Event|Habitual Silicone Hydrogel|Habitual contact lens wear.
367920|NCT00709761|B1|Baseline|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367921|NCT00709761|P1|Participant Flow|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367922|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367923|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367924|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367925|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367926|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367927|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367928|NCT00709761|E1|Reported Event|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
367929|NCT00709722|B1|Baseline|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367930|NCT00709722|P1|Participant Flow|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367931|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367932|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367933|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367934|NCT00709722|E1|Reported Event|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
367935|NCT00709618|B1|Baseline|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367936|NCT00709618|P1|Participant Flow|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 milligrams per meters squared [mg/m^2]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367937|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367938|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367939|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367940|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367941|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367942|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367943|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367944|NCT00709618|E1|Reported Event|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
367945|NCT00709592|B3|Baseline|Total|Total of all reporting groups
367946|NCT00709592|B2|Baseline|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367947|NCT00709592|B1|Baseline|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367948|NCT00709592|P2|Participant Flow|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367949|NCT00709592|P1|Participant Flow|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367950|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367951|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367952|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367953|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367954|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367955|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367956|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367957|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367958|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367959|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367960|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367961|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367962|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367963|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367964|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367965|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367966|NCT00709592|E2|Reported Event|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
367967|NCT00709592|E1|Reported Event|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
367968|NCT00709319|B1|Baseline|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367969|NCT00709319|P1|Participant Flow|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367970|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367971|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367972|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367973|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367974|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367975|NCT00709319|E1|Reported Event|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
367976|NCT00709228|B1|Baseline|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
367977|NCT00709228|P1|Participant Flow|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
367978|NCT00709228|O1|Outcome|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
367979|NCT00709228|E1|Reported Event|PegInton Plus Rebetol|
367980|NCT00709124|B3|Baseline|Total|Total of all reporting groups
367981|NCT00709124|B2|Baseline|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
367982|NCT00709124|B1|Baseline|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
367983|NCT00709124|P2|Participant Flow|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
367984|NCT00709124|P1|Participant Flow|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
367985|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
367986|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
367987|NCT00709124|E2|Reported Event|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
367988|NCT00709124|E1|Reported Event|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
367989|NCT00709111|B1|Baseline|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367990|NCT00709111|P1|Participant Flow|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367991|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367992|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367993|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367994|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367995|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367996|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367997|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367998|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
367999|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368000|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368001|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368002|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368003|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368004|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368005|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368006|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368007|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368008|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368009|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368010|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368011|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368012|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368013|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368014|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368015|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368016|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368017|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368018|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368019|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368020|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368021|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368022|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368023|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368024|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368025|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368026|NCT00709111|E1|Reported Event|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
368027|NCT00709098|B4|Baseline|Total|Total of all reporting groups
368028|NCT00709098|B3|Baseline|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368029|NCT00709098|B2|Baseline|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368030|NCT00709098|B1|Baseline|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368031|NCT00709098|P3|Participant Flow|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368032|NCT00709098|P2|Participant Flow|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368033|NCT00709098|P1|Participant Flow|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368034|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368035|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
368036|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368037|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368038|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368039|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368040|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368041|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368042|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368043|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368044|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368045|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368046|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368047|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368048|NCT00709098|E3|Reported Event|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368811|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368049|NCT00709098|E2|Reported Event|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
368050|NCT00709098|E1|Reported Event|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
368051|NCT00709059|B1|Baseline|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
368052|NCT00709059|P1|Participant Flow|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
368053|NCT00709059|O1|Outcome|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
368054|NCT00709059|E1|Reported Event|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
368055|NCT00708942|B6|Baseline|Total|Total of all reporting groups
368056|NCT00708942|B5|Baseline|Arm 5: Placebo Ointment, no Illumination|
368057|NCT00708942|B4|Baseline|Arm 4: HAL Ointment, LED Diode Illumination|
368058|NCT00708942|B3|Baseline|Arm 3: No Intervention|
368059|NCT00708942|B2|Baseline|Arm 2: Placebo Suppository, Laser Illumination|
368060|NCT00708942|B1|Baseline|Arm 1: HAL Suppository, Laser Illumination|
368061|NCT00708942|P5|Participant Flow|Arm 5: Placebo Ointment, no Illumination|
368062|NCT00708942|P4|Participant Flow|Arm 4: HAL Ointment, LED Diode Illumination|
368063|NCT00708942|P3|Participant Flow|Arm 3: No Intervention|
368064|NCT00708942|P2|Participant Flow|Arm 2: Placebo Suppository, Laser Illumination|
368065|NCT00708942|P1|Participant Flow|Arm 1: HAL Suppository, Laser Illumination|
368066|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
368067|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
368068|NCT00708942|O3|Outcome|Arm 3: No Intervention|
368069|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
368070|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
368071|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
368072|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
368073|NCT00708942|O3|Outcome|Arm 3: No Intervention|
368074|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
368075|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
368076|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
368077|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
368078|NCT00708942|O3|Outcome|Arm 3: No Intervention|
368079|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
368080|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
368081|NCT00708942|E5|Reported Event|Arm 5: Placebo Ointment, no Illumination|
368082|NCT00708942|E4|Reported Event|Arm 4: HAL Ointment, LED Diode Illumination|
368083|NCT00708942|E3|Reported Event|Arm 3: No Intervention|
368084|NCT00708942|E2|Reported Event|Arm 2: Placebo Suppository, Laser Illumination|
368085|NCT00708942|E1|Reported Event|Arm 1: HAL Suppository, Laser Illumination|
368086|NCT00708877|B1|Baseline|Transplant|All patients enrolled in study.
368087|NCT00708877|P1|Participant Flow|Transplant|All patients enrolled in study.
368088|NCT00708877|O1|Outcome|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
368089|NCT00708877|E1|Reported Event|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
368090|NCT00708851|B1|Baseline|NB-UVB Alone|"One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week~Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week"
368091|NCT00708851|P1|Participant Flow|NB-UVB and NB-UVB+LCD|"NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week~NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week"
368092|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
368093|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
368094|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
368095|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
368096|NCT00708851|E2|Reported Event|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
368097|NCT00708851|E1|Reported Event|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
368098|NCT00708526|B3|Baseline|Total|Total of all reporting groups
368099|NCT00708526|B2|Baseline|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
368100|NCT00708526|B1|Baseline|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
368101|NCT00708526|P2|Participant Flow|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
368102|NCT00708526|P1|Participant Flow|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
368103|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
373108|NCT00699608|O1|Outcome|Placebo|Placebo
368104|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
368105|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
368106|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
368107|NCT00708526|E2|Reported Event|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
368108|NCT00708526|E1|Reported Event|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
368109|NCT00708500|B4|Baseline|Total|Total of all reporting groups
368110|NCT00708500|B3|Baseline|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368111|NCT00708500|B2|Baseline|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368112|NCT00708500|B1|Baseline|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368113|NCT00708500|P3|Participant Flow|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368114|NCT00708500|P2|Participant Flow|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368115|NCT00708500|P1|Participant Flow|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368116|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368117|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368118|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368119|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368120|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368121|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368122|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368151|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368152|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368153|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
368815|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368123|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368124|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368125|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368126|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368127|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368128|NCT00708500|E3|Reported Event|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368129|NCT00708500|E2|Reported Event|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
368130|NCT00708500|E1|Reported Event|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
368131|NCT00708461|B3|Baseline|Total|Total of all reporting groups
368132|NCT00708461|B2|Baseline|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
368133|NCT00708461|B1|Baseline|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
368134|NCT00708461|P2|Participant Flow|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
368135|NCT00708461|P1|Participant Flow|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
368136|NCT00708461|O2|Outcome|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
368137|NCT00708461|O1|Outcome|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
368138|NCT00708461|E2|Reported Event|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
368139|NCT00708461|E1|Reported Event|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
368140|NCT00708435|B3|Baseline|Total|Total of all reporting groups
368141|NCT00708435|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
368142|NCT00708435|B1|Baseline|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368143|NCT00708435|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
368144|NCT00708435|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
368145|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368146|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368147|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368148|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368149|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368150|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368154|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368155|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
368156|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368157|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
368158|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368159|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368160|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368161|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368162|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368163|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368164|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
368165|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368166|NCT00708435|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
368167|NCT00708435|E1|Reported Event|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
368168|NCT00708422|B3|Baseline|Total|Total of all reporting groups
368169|NCT00708422|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
368170|NCT00708422|B1|Baseline|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
368171|NCT00708422|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
368172|NCT00708422|P1|Participant Flow|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
368173|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
368174|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
368175|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
368176|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
368177|NCT00708422|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
368178|NCT00708422|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
368179|NCT00708305|B1|Baseline|Overall Study|All randomized participants
368180|NCT00708305|P4|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368181|NCT00708305|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368182|NCT00708305|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368183|NCT00708305|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368184|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368185|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368186|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368187|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
368188|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368241|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
373109|NCT00699608|E3|Reported Event|Zopiclone|7.5 mg Zopiclone
368189|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368190|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368191|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368192|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368193|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368194|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368195|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368196|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368197|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368198|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368199|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368200|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368201|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368202|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368203|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368204|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368205|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368206|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368207|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368208|NCT00708305|O2|Outcome|NaF Toothpaste (1400 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368209|NCT00708305|O1|Outcome|NaF Toothpaste(1450 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368242|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368210|NCT00708305|E4|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368211|NCT00708305|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368212|NCT00708305|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368213|NCT00708305|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
368214|NCT00708214|B4|Baseline|Total|Total of all reporting groups
368215|NCT00708214|B3|Baseline|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368216|NCT00708214|B2|Baseline|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368217|NCT00708214|B1|Baseline|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368218|NCT00708214|P3|Participant Flow|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368219|NCT00708214|P2|Participant Flow|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368220|NCT00708214|P1|Participant Flow|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368221|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368222|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368223|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368224|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368225|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5 mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368226|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368227|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368228|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368229|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368230|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368231|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368232|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368233|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368234|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368235|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368236|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368237|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368238|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368239|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368240|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
373110|NCT00699608|E2|Reported Event|Eszopiclone|3 mg Eszopiclone
368243|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368244|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368245|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368246|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368247|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368248|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368249|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368250|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368251|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368252|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368253|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368254|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368255|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368256|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368257|NCT00708214|E3|Reported Event|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368258|NCT00708214|E2|Reported Event|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368259|NCT00708214|E1|Reported Event|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
368260|NCT00708201|B3|Baseline|Total|Total of all reporting groups
368261|NCT00708201|B2|Baseline|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368262|NCT00708201|B1|Baseline|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368263|NCT00708201|P2|Participant Flow|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368264|NCT00708201|P1|Participant Flow|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368265|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368266|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368267|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368268|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368269|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368270|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368271|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368272|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368273|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368274|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368275|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368276|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368277|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368278|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368279|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368280|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368281|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368282|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368283|NCT00708201|E2|Reported Event|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
368284|NCT00708201|E1|Reported Event|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
368285|NCT00708175|B3|Baseline|Total|Total of all reporting groups
368286|NCT00708175|B2|Baseline|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368287|NCT00708175|B1|Baseline|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368288|NCT00708175|P2|Participant Flow|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368289|NCT00708175|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368290|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368291|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368292|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368293|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368294|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368295|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368296|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368297|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368298|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368299|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368300|NCT00708175|E2|Reported Event|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
368301|NCT00708175|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
368302|NCT00708162|B3|Baseline|Total|Total of all reporting groups
368303|NCT00708162|B2|Baseline|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368385|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368304|NCT00708162|B1|Baseline|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368305|NCT00708162|P2|Participant Flow|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368306|NCT00708162|P1|Participant Flow|Elvitegravir|Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368307|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368308|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368309|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368310|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368311|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368312|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368313|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368314|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368315|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368316|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368317|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368318|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368319|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368320|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368321|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368322|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368323|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368324|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368325|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368326|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368327|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
373111|NCT00699608|E1|Reported Event|Placebo|Placebo
368328|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368329|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368330|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368331|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368332|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368333|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368334|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368335|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368336|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368337|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368338|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368339|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368340|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368341|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368342|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
368343|NCT00708162|E3|Reported Event|All Elvitegravir|Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
368344|NCT00708162|E2|Reported Event|Raltegravir|"Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase~RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
368345|NCT00708162|E1|Reported Event|Elvitegravir|"Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase~EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
368346|NCT00708123|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
368347|NCT00708123|P5|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
368348|NCT00708123|P4|Participant Flow|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368349|NCT00708123|P3|Participant Flow|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368350|NCT00708123|P2|Participant Flow|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368351|NCT00708123|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368812|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368352|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
368353|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368354|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368355|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368356|NCT00708123|O1|Outcome|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368357|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
368358|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368359|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368360|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368361|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368362|NCT00708123|O3|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
368363|NCT00708123|O2|Outcome|NaF Toothpaste (1350 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368364|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368365|NCT00708123|E5|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
368366|NCT00708123|E4|Reported Event|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368367|NCT00708123|E3|Reported Event|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368368|NCT00708123|E2|Reported Event|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368369|NCT00708123|E1|Reported Event|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
368370|NCT00708110|B5|Baseline|Total|Total of all reporting groups
368371|NCT00708110|B4|Baseline|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368372|NCT00708110|B3|Baseline|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368373|NCT00708110|B2|Baseline|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368374|NCT00708110|B1|Baseline|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368375|NCT00708110|P4|Participant Flow|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368376|NCT00708110|P3|Participant Flow|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368377|NCT00708110|P2|Participant Flow|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368378|NCT00708110|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368379|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368380|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368381|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368382|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368383|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368384|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368386|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368387|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368388|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368389|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368390|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368391|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368392|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368393|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368394|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368395|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368396|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368397|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368398|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368399|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368400|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368401|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368402|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368403|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368404|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368405|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368406|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368407|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368408|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368409|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368410|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368411|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368412|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368413|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368414|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368415|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368416|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368417|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368418|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368419|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368420|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368421|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368422|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368423|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368424|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368425|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368426|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368427|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368428|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368429|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368430|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368431|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368432|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368433|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368434|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368435|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368436|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368437|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368438|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368439|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368440|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368441|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368442|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368443|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368444|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368445|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368446|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368447|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368448|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368449|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368450|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368451|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368452|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368453|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368454|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368455|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368456|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368457|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368458|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368459|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368460|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368461|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368462|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368463|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368464|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368465|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368466|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368467|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368468|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368469|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368470|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368813|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368471|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368472|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368473|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368474|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368475|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368476|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368477|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368478|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368479|NCT00708110|E4|Reported Event|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
368480|NCT00708110|E3|Reported Event|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
368481|NCT00708110|E2|Reported Event|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
368482|NCT00708110|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
368483|NCT00708097|B1|Baseline|All Randomized Participants|All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
368484|NCT00708097|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368485|NCT00708097|P4|Participant Flow|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368486|NCT00708097|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368487|NCT00708097|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368488|NCT00708097|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368489|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368490|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368491|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368492|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368493|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368494|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368562|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368495|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368496|NCT00708097|O3|Outcome|NaMFP/ NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368497|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368498|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368499|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368500|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368501|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368502|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368503|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368504|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368505|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368506|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368507|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368508|NCT00708097|O1|Outcome|NaF/Carbopol Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368509|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368510|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368511|NCT00708097|E6|Reported Event|Overall|All participants received all treatments during the study
368563|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368564|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368512|NCT00708097|E5|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368513|NCT00708097|E4|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368514|NCT00708097|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368515|NCT00708097|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368516|NCT00708097|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
368517|NCT00708071|B1|Baseline|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368518|NCT00708071|P1|Participant Flow|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368519|NCT00708071|O1|Outcome|Facelift Participants|
368520|NCT00708071|O3|Outcome|SoC Looks Better|
368521|NCT00708071|O2|Outcome|FS VH S/D 4 Looks Better|
368522|NCT00708071|O1|Outcome|No Difference|
368523|NCT00708071|O1|Outcome|Facelift Participants|
368524|NCT00708071|O1|Outcome|Facelift Participants|
368525|NCT00708071|O8|Outcome|SoC - Day 14|
368526|NCT00708071|O7|Outcome|FS VH S/D 4 - Day 14|
368527|NCT00708071|O6|Outcome|SoC - Day 10|
368528|NCT00708071|O5|Outcome|FS VH S/D 4 - Day 10|
368529|NCT00708071|O4|Outcome|SoC - Day 7|
368530|NCT00708071|O3|Outcome|FS VH S/D 4 - Day 7|
368531|NCT00708071|O2|Outcome|SoC - Day 3|
368532|NCT00708071|O1|Outcome|FS VH S/D 4 - Day3|
368533|NCT00708071|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
368534|NCT00708071|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
368535|NCT00708071|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
368536|NCT00708071|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 Side|
368537|NCT00708071|O2|Outcome|FS VH S/D 4|
368538|NCT00708071|O1|Outcome|Standard of Care (SoC)|
368539|NCT00708071|O2|Outcome|FS VH S/D 4|
368540|NCT00708071|O1|Outcome|Standard of Care (SoC)|
368541|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
368542|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
368543|NCT00708071|O2|Outcome|Complete Resolution of Edema With SoC But Not FS VH S/D 4|
368544|NCT00708071|O1|Outcome|Complete Resolution of Edema With FS VH S/D 4 But Not SoC|
368545|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
368546|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
368547|NCT00708071|O2|Outcome|Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4|
368548|NCT00708071|O1|Outcome|Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC|
368549|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368550|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368551|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368552|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368553|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368554|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368555|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368556|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368557|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368558|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368559|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368560|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368561|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368565|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368566|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368567|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
368568|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368569|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368570|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368571|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368572|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368573|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368574|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368575|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368576|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368577|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368578|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368579|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368580|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368581|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368582|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368583|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368584|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368585|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368586|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368587|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368588|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
368589|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
368590|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
368591|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
368592|NCT00708071|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
368593|NCT00708071|E2|Reported Event|Localized to FS VH S/D 4 Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4.
368594|NCT00708071|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care.
368595|NCT00708032|B3|Baseline|Total|Total of all reporting groups
368596|NCT00708032|B2|Baseline|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368597|NCT00708032|B1|Baseline|Spectacles|spectacles worn daily for 12 months
368598|NCT00708032|P2|Participant Flow|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368599|NCT00708032|P1|Participant Flow|Spectacles|spectacles worn daily for 12 months
368600|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
368601|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368602|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
368603|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368604|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
368605|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368606|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
368607|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368608|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
368609|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368610|NCT00708032|E2|Reported Event|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
368611|NCT00708032|E1|Reported Event|Spectacles|spectacles worn daily for 12 months
368612|NCT00708019|B3|Baseline|Total|Total of all reporting groups
368613|NCT00708019|B2|Baseline|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368614|NCT00708019|B1|Baseline|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368814|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368615|NCT00708019|P2|Participant Flow|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368616|NCT00708019|P1|Participant Flow|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368617|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368618|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368619|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368620|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368621|NCT00708019|E2|Reported Event|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368622|NCT00708019|E1|Reported Event|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
368623|NCT00707993|B3|Baseline|Total|Total of all reporting groups
368624|NCT00707993|B2|Baseline|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
373112|NCT00699582|B4|Baseline|Total|Total of all reporting groups
368625|NCT00707993|B1|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368626|NCT00707993|P2|Participant Flow|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368627|NCT00707993|P1|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368628|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368629|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368630|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368631|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368632|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368633|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368634|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368635|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368636|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368637|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368638|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368639|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368640|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368641|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368642|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368643|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368644|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368645|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368646|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368647|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368648|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368649|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368650|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368651|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368652|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368653|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368654|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368655|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368656|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368657|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368658|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368659|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368660|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368661|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368662|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368663|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368664|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368665|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368666|NCT00707993|E2|Reported Event|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
368667|NCT00707993|E1|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
368668|NCT00707980|B1|Baseline|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368669|NCT00707980|P1|Participant Flow|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368670|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368671|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368672|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368673|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368674|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368675|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368676|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368677|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368678|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368679|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368680|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368681|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368682|NCT00707980|E1|Reported Event|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
368683|NCT00707967|B4|Baseline|Total|Total of all reporting groups
368684|NCT00707967|B3|Baseline|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368685|NCT00707967|B2|Baseline|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368686|NCT00707967|B1|Baseline|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368748|NCT00707954|B5|Baseline|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368687|NCT00707967|P3|Participant Flow|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368688|NCT00707967|P2|Participant Flow|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368689|NCT00707967|P1|Participant Flow|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368690|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368691|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368692|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368693|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368694|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368695|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368696|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368697|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368698|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368699|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368700|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368701|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368702|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368703|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368704|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368705|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368706|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368707|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368708|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368709|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368710|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368711|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368712|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368713|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368714|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368715|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368716|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368806|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368717|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368718|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368719|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368720|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368721|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368722|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368723|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368724|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368725|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368726|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368727|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368728|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368729|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368730|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368731|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368732|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368733|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368734|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368735|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368736|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368737|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368738|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368739|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368740|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368741|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368742|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368743|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368744|NCT00707967|E3|Reported Event|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368745|NCT00707967|E2|Reported Event|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368746|NCT00707967|E1|Reported Event|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
368747|NCT00707954|B6|Baseline|Total|Total of all reporting groups
373200|NCT00699400|E1|Reported Event|Slow Freezing|
368749|NCT00707954|B4|Baseline|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368750|NCT00707954|B3|Baseline|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368751|NCT00707954|B2|Baseline|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368752|NCT00707954|B1|Baseline|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368753|NCT00707954|P5|Participant Flow|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368754|NCT00707954|P4|Participant Flow|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368755|NCT00707954|P3|Participant Flow|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368756|NCT00707954|P2|Participant Flow|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368757|NCT00707954|P1|Participant Flow|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368758|NCT00707954|O5|Outcome|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368759|NCT00707954|O4|Outcome|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368760|NCT00707954|O3|Outcome|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368761|NCT00707954|O2|Outcome|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368762|NCT00707954|O1|Outcome|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368763|NCT00707954|E5|Reported Event|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368764|NCT00707954|E4|Reported Event|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368765|NCT00707954|E3|Reported Event|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368766|NCT00707954|E2|Reported Event|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368767|NCT00707954|E1|Reported Event|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
368768|NCT00707915|B1|Baseline|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368769|NCT00707915|P1|Participant Flow|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368770|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368771|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368772|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368773|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368774|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368775|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368776|NCT00707915|E1|Reported Event|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
368777|NCT00707863|B3|Baseline|Total|Total of all reporting groups
368778|NCT00707863|B2|Baseline|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368779|NCT00707863|B1|Baseline|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368780|NCT00707863|P2|Participant Flow|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368781|NCT00707863|P1|Participant Flow|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368782|NCT00707863|O2|Outcome|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368783|NCT00707863|O1|Outcome|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368784|NCT00707863|E2|Reported Event|Subjects Age: 26 - 50|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks"
368785|NCT00707863|E1|Reported Event|Subjects Age: 18 - 25|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
368786|NCT00707759|B3|Baseline|Total|Total of all reporting groups
368807|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368808|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368809|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368810|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368787|NCT00707759|B2|Baseline|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
368788|NCT00707759|B1|Baseline|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
368789|NCT00707759|P2|Participant Flow|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
368790|NCT00707759|P1|Participant Flow|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
368791|NCT00707759|O2|Outcome|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
368792|NCT00707759|O1|Outcome|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
368793|NCT00707759|E2|Reported Event|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
368794|NCT00707759|E1|Reported Event|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
368795|NCT00707746|B3|Baseline|Total|Total of all reporting groups
368796|NCT00707746|B2|Baseline|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368797|NCT00707746|B1|Baseline|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368798|NCT00707746|P2|Participant Flow|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368799|NCT00707746|P1|Participant Flow|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368800|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368801|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368802|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368803|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368804|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368805|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368816|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368817|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368818|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368819|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368820|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368821|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368822|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368823|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368824|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368825|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368826|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368827|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368828|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368829|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368830|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368831|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368832|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368833|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368834|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368835|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368836|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368837|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368838|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368839|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368840|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368841|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368842|NCT00707746|E2|Reported Event|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
368843|NCT00707746|E1|Reported Event|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
368844|NCT00707655|B3|Baseline|Total|Total of all reporting groups
368845|NCT00707655|B2|Baseline|Zalutumumab 8 mg/kg|8 weekly infusions
368846|NCT00707655|B1|Baseline|Zalutumumab 4 mg/kg|8 weekly infusions
368847|NCT00707655|P2|Participant Flow|Zalutumumab 8 mg/kg|8 weekly infusions
368848|NCT00707655|P1|Participant Flow|Zalutumumab 4 mg/kg|8 weekly infusions
368849|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
368850|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
368851|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
368852|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
368853|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|
368854|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|
368855|NCT00707655|E2|Reported Event|Zalutumumab 8 mg/kg|8 weekly infusions
368856|NCT00707655|E1|Reported Event|Zalutumumab 4 mg/kg|8 weekly infusions
368857|NCT00707486|B1|Baseline|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
368858|NCT00707486|P1|Participant Flow|Hemcon Dental Dressing With Pressure|Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
368859|NCT00707486|O3|Outcome|Total|
368860|NCT00707486|O2|Outcome|Control: Gauze|
368861|NCT00707486|O1|Outcome|HemCon|Experimental
368862|NCT00707486|O3|Outcome|Total|
368863|NCT00707486|O2|Outcome|Control: Gauze|
368864|NCT00707486|O1|Outcome|HemCon|Experimental
368865|NCT00707486|E1|Reported Event|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
368866|NCT00707447|B3|Baseline|Total|Total of all reporting groups
368867|NCT00707447|B2|Baseline|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
368868|NCT00707447|B1|Baseline|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
368869|NCT00707447|P2|Participant Flow|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
368870|NCT00707447|P1|Participant Flow|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
368871|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368872|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368873|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368874|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368875|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
369007|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
368876|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368877|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368878|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368879|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368880|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368881|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368882|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368883|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368884|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368885|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368886|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368887|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368888|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368889|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
368890|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
368891|NCT00707447|E2|Reported Event|2/PREDIAS|Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
368892|NCT00707447|E1|Reported Event|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
368893|NCT00707343|B1|Baseline|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
368894|NCT00707343|P1|Participant Flow|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
368895|NCT00707343|O1|Outcome|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
368896|NCT00707343|E1|Reported Event|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
368897|NCT00707239|B4|Baseline|Total|Total of all reporting groups
368898|NCT00707239|B3|Baseline|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368899|NCT00707239|B2|Baseline|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368900|NCT00707239|B1|Baseline|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368901|NCT00707239|P3|Participant Flow|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368902|NCT00707239|P2|Participant Flow|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368903|NCT00707239|P1|Participant Flow|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
373201|NCT00699374|B3|Baseline|Total|Total of all reporting groups
368904|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368905|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368906|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368907|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
368908|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
368909|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
368910|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
368911|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
368912|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368913|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368914|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
368915|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368916|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368917|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368918|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368919|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368920|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368921|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368922|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368923|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368924|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368925|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368926|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368927|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368928|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368929|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368930|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368931|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368932|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368933|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368934|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368935|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368936|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368937|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368938|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368939|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368940|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368941|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368942|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368943|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368944|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368945|NCT00707239|E3|Reported Event|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368946|NCT00707239|E2|Reported Event|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
368947|NCT00707239|E1|Reported Event|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
368948|NCT00707174|B3|Baseline|Total|Total of all reporting groups
368949|NCT00707174|B2|Baseline|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
368950|NCT00707174|B1|Baseline|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
368951|NCT00707174|P2|Participant Flow|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
368952|NCT00707174|P1|Participant Flow|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
368953|NCT00707174|O2|Outcome|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
368954|NCT00707174|O1|Outcome|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
369008|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369009|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
368955|NCT00707174|E2|Reported Event|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
368956|NCT00707174|E1|Reported Event|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
368957|NCT00707161|B1|Baseline|Treatment Arm (Radiation Therapy & Cisplatin)|
368958|NCT00707161|P1|Participant Flow|Treatment Arm (Radiation Therapy & Cisplatin)|All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
368959|NCT00707161|O1|Outcome|Treatment Arm (Radiation & Cisplatin)|Group of participants receiving Radiation and Cisplatin.
368960|NCT00707161|E1|Reported Event|Treatment Arm (Radiation Therapy & Cisplatin)|All enrolled participants.
368961|NCT00707057|B3|Baseline|Total|Total of all reporting groups
368962|NCT00707057|B2|Baseline|Placebo|Participants received placebo tablet twice daily (BID)
368963|NCT00707057|B1|Baseline|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368964|NCT00707057|P2|Participant Flow|Placebo|Participants received placebo tablet twice daily (BID)
368965|NCT00707057|P1|Participant Flow|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368966|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368967|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368968|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368969|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368970|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368971|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368972|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368973|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368974|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368975|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368976|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368977|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368978|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368979|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368980|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368981|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368982|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368983|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368984|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368985|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368986|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368987|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368988|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368989|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368990|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368991|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368992|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
368993|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368994|NCT00707057|E2|Reported Event|Placebo|Participants received placebo tablet twice daily (BID)
368995|NCT00707057|E1|Reported Event|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
368996|NCT00707031|B3|Baseline|Total|Total of all reporting groups
368997|NCT00707031|B2|Baseline|Exenatide|1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
368998|NCT00707031|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
368999|NCT00707031|P2|Participant Flow|Exenatide|1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
369000|NCT00707031|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
369001|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
369002|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369003|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
369004|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369005|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
369006|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369010|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369011|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
369012|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369013|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
369014|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369015|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
369016|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369017|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
369018|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
369019|NCT00707031|E2|Reported Event|Exenatide|1-step initiation regimen of exenatide.
369020|NCT00707031|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
369021|NCT00706992|B8|Baseline|Total|Total of all reporting groups
369022|NCT00706992|B7|Baseline|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369023|NCT00706992|B6|Baseline|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
369024|NCT00706992|B5|Baseline|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369025|NCT00706992|B4|Baseline|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369026|NCT00706992|B3|Baseline|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369027|NCT00706992|B2|Baseline|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
369028|NCT00706992|B1|Baseline|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
369029|NCT00706992|P7|Participant Flow|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369030|NCT00706992|P6|Participant Flow|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
369031|NCT00706992|P5|Participant Flow|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369032|NCT00706992|P4|Participant Flow|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369033|NCT00706992|P3|Participant Flow|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369034|NCT00706992|P2|Participant Flow|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
369035|NCT00706992|P1|Participant Flow|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
369036|NCT00706992|O7|Outcome|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369037|NCT00706992|O6|Outcome|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
369038|NCT00706992|O5|Outcome|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369039|NCT00706992|O4|Outcome|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369040|NCT00706992|O3|Outcome|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369041|NCT00706992|O2|Outcome|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
369042|NCT00706992|O1|Outcome|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
369043|NCT00706992|O1|Outcome|Arm I - 6|Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
369044|NCT00706992|E7|Reported Event|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369045|NCT00706992|E6|Reported Event|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
369046|NCT00706992|E5|Reported Event|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
369047|NCT00706992|E4|Reported Event|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369048|NCT00706992|E3|Reported Event|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
369049|NCT00706992|E2|Reported Event|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
369050|NCT00706992|E1|Reported Event|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
369051|NCT00706979|B3|Baseline|Total|Total of all reporting groups
369052|NCT00706979|B2|Baseline|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369053|NCT00706979|B1|Baseline|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369054|NCT00706979|P2|Participant Flow|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369055|NCT00706979|P1|Participant Flow|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369056|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369057|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369058|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369059|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369060|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369061|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369062|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369063|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369064|NCT00706979|E2|Reported Event|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
369065|NCT00706979|E1|Reported Event|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
369066|NCT00706966|B1|Baseline|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
369067|NCT00706966|P1|Participant Flow|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
369068|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
369069|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
369070|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
369109|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
369071|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
369072|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
369073|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
369074|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
369075|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
369076|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
369077|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
369078|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
369079|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
369080|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
369081|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
369082|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
369083|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
369084|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
369085|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
369086|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
369087|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
369088|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
369089|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
369090|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
369091|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
369092|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
369093|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
369094|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
369095|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
369096|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
369097|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
369098|NCT00706966|E1|Reported Event|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride: 6 months of dutasteride 3.5 mg daily"
369099|NCT00706901|B4|Baseline|Total|Total of all reporting groups
369100|NCT00706901|B3|Baseline|Arm 3 TCC|Treatment Control condition
369101|NCT00706901|B2|Baseline|Arm 2 IHMD|In-Home-Messaging Device
369102|NCT00706901|B1|Baseline|Arm 1 GMI|Group Motivational Interviewing
369103|NCT00706901|P3|Participant Flow|Arm 3 TCC|Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
369104|NCT00706901|P2|Participant Flow|Arm 2 IHMD|Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
369105|NCT00706901|P1|Participant Flow|Arm 1 GMI|Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
369106|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
369107|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
369108|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
369126|NCT00706901|E1|Reported Event|Arm 1 GMI|Group Motivational Interviewing
369127|NCT00706849|B3|Baseline|Total|Total of all reporting groups
369128|NCT00706849|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369129|NCT00706849|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369130|NCT00706849|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369131|NCT00706849|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369132|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369133|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369134|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369135|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369136|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369137|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369138|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369139|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369140|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369141|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369142|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369143|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369144|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369145|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369146|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369147|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369148|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369149|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369150|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369151|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369152|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369153|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369154|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369155|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369156|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369157|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369158|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369159|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369160|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369161|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369162|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369163|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369164|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369165|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369166|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369167|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369168|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369169|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369170|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369171|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369172|NCT00706849|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
369173|NCT00706849|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
369174|NCT00706836|B1|Baseline|All 3 Treatments (Cross-Over Design)|"Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo~All subjects received all 3 treatments on different days.~Sequence data not available."
369175|NCT00706836|P1|Participant Flow|All Study Participants|"Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo~All participants received all 3 treatments on different days.~Sequence not available."
369176|NCT00706836|O3|Outcome|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
369177|NCT00706836|O2|Outcome|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
369178|NCT00706836|O1|Outcome|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
369179|NCT00706836|E3|Reported Event|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
369180|NCT00706836|E2|Reported Event|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
369181|NCT00706836|E1|Reported Event|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
369182|NCT00706823|B3|Baseline|Total|Total of all reporting groups
369183|NCT00706823|B2|Baseline|LMA-Unique|Patients who received LMA-Unique for intubation
369184|NCT00706823|B1|Baseline|I-gel-SGA|Patients who received i-gel SGA for intubation
369185|NCT00706823|P2|Participant Flow|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
369186|NCT00706823|P1|Participant Flow|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
369187|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369188|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369189|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369190|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369191|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369192|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369193|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369194|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369195|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369196|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369197|NCT00706823|O2|Outcome|uLMA|Patients who received uLMA for intubation
369198|NCT00706823|O1|Outcome|I-gel|Patients who received i-gel for intubation
369199|NCT00706823|E2|Reported Event|uLMA|Patients who received uLMA for intubation
369200|NCT00706823|E1|Reported Event|I-gel|Patients who received i-gel for intubation
369201|NCT00706797|B3|Baseline|Total|Total of all reporting groups
369202|NCT00706797|B2|Baseline|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369203|NCT00706797|B1|Baseline|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369204|NCT00706797|P2|Participant Flow|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369205|NCT00706797|P1|Participant Flow|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369206|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369207|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369208|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369209|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369210|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369211|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369212|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369213|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369214|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369290|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369215|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369216|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369217|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369218|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369219|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369220|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369221|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369222|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369223|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369224|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369225|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369226|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369227|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369228|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369229|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369230|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369231|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369232|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369233|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369234|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369235|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369236|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369237|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369238|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369239|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369240|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
369241|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369242|NCT00706797|E2|Reported Event|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
373615|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
369243|NCT00706797|E1|Reported Event|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
369244|NCT00706784|B3|Baseline|Total|Total of all reporting groups
369245|NCT00706784|B2|Baseline|36 mg Leuprolide for 3 Days|
369246|NCT00706784|B1|Baseline|18 mg Leuprolide for 3 Days|
369247|NCT00706784|P2|Participant Flow|36 mg Leuprolide for 3 Days|
369248|NCT00706784|P1|Participant Flow|18 mg Leuprolide for 3 Days|
369249|NCT00706784|O2|Outcome|36 mg Leuprolide for 3 Days|
369250|NCT00706784|O1|Outcome|18 mg Leuprolide for 3 Days|
369251|NCT00706784|E2|Reported Event|36 mg Leuprolide for 3 Days|
369252|NCT00706784|E1|Reported Event|18 mg Leuprolide for 3 Days|
369253|NCT00706719|B4|Baseline|Total|Total of all reporting groups
369254|NCT00706719|B3|Baseline|Group C Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
369255|NCT00706719|B2|Baseline|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369256|NCT00706719|B1|Baseline|Group A Testim|1% Testim gel applied daily
369257|NCT00706719|P3|Participant Flow|Group C Androxal With Wash Out|25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
369258|NCT00706719|P2|Participant Flow|Group B Androxal no Washout|25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
369259|NCT00706719|P1|Participant Flow|Group A Testim (Topical Testosterone)|1% Testim gel applied once daily
369260|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369261|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
369262|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369263|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
369264|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369265|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
369266|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369267|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
369268|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369269|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
369270|NCT00706719|E3|Reported Event|Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
369271|NCT00706719|E2|Reported Event|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
369272|NCT00706719|E1|Reported Event|Group A Testim|1% Testim gel applied daily
369273|NCT00706706|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369274|NCT00706706|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369275|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369276|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369277|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369278|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369279|NCT00706706|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
369280|NCT00706654|B4|Baseline|Total|Total of all reporting groups
369281|NCT00706654|B3|Baseline|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369282|NCT00706654|B2|Baseline|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369283|NCT00706654|B1|Baseline|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369284|NCT00706654|P4|Participant Flow|Aripiprazole Depot 25 or 50 mg|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369285|NCT00706654|P3|Participant Flow|Aripiprazole 10-30 mg Orally|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369286|NCT00706654|P2|Participant Flow|Aripiprazole Depot 300 or 400 mg|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369287|NCT00706654|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
369288|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369289|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369291|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369292|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369293|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369294|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369295|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369296|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369297|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369298|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369299|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369300|NCT00706654|E5|Reported Event|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
369301|NCT00706654|E4|Reported Event|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
369302|NCT00706654|E3|Reported Event|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
369303|NCT00706654|E2|Reported Event|All Patients - Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
369304|NCT00706654|E1|Reported Event|All Patients - Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
369305|NCT00706641|B1|Baseline|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369306|NCT00706641|P1|Participant Flow|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369307|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369308|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369309|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369310|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369311|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369842|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369312|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369313|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369314|NCT00706641|E1|Reported Event|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
369315|NCT00706628|B5|Baseline|Total|Total of all reporting groups
369316|NCT00706628|B4|Baseline|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369317|NCT00706628|B3|Baseline|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369318|NCT00706628|B2|Baseline|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369319|NCT00706628|B1|Baseline|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369320|NCT00706628|P4|Participant Flow|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events (AE) reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369321|NCT00706628|P3|Participant Flow|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369322|NCT00706628|P2|Participant Flow|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369323|NCT00706628|P1|Participant Flow|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369324|NCT00706628|O1|Outcome|Combination Therapy of BIBF 1120 and BIBW 2992|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~C12,14 values of BIBF 1120 BS after sequential alternating 7−days administration of 250 mg BIBF 1120 bid;~C24,7, C24,14 and C24,42 values of BIBW 2992 BS after sequential alternating 7−days administration of 40 mg BIBW 2992 qd"
369325|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369326|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369327|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369373|NCT00706589|P2|Participant Flow|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
369328|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369329|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369330|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369331|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369332|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369333|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369334|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369335|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369336|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369337|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369338|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369339|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369340|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369341|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369342|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369343|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369344|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369345|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369346|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369347|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369348|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369349|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369781|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369350|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369351|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369352|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369353|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369354|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369355|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369356|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369357|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369358|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369359|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369360|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369361|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369362|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle. The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged. Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369363|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369364|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369365|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369366|NCT00706628|E4|Reported Event|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
369367|NCT00706628|E3|Reported Event|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
369368|NCT00706628|E2|Reported Event|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369369|NCT00706628|E1|Reported Event|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
369370|NCT00706589|B3|Baseline|Total|Total of all reporting groups
369371|NCT00706589|B2|Baseline|Placebo|Placebo 2mg,5mg,10mg,15mg
369372|NCT00706589|B1|Baseline|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
369374|NCT00706589|P1|Participant Flow|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O
369375|NCT00706589|O2|Outcome|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg
369376|NCT00706589|O1|Outcome|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg
369377|NCT00706589|E2|Reported Event|Placebo|Placebo 2mg,5mg,10mg,15mg
369378|NCT00706589|E1|Reported Event|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
369379|NCT00706563|B3|Baseline|Total|Total of all reporting groups
369380|NCT00706563|B2|Baseline|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369381|NCT00706563|B1|Baseline|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369382|NCT00706563|P2|Participant Flow|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369383|NCT00706563|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369384|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369385|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369386|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369387|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369388|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369389|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369390|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369391|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369392|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369393|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369394|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369395|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369396|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369397|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369398|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369399|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369400|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369401|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369402|NCT00706563|E2|Reported Event|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
369403|NCT00706563|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
369404|NCT00706550|B3|Baseline|Total|Total of all reporting groups
369405|NCT00706550|B2|Baseline|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
369406|NCT00706550|B1|Baseline|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
369407|NCT00706550|P2|Participant Flow|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369408|NCT00706550|P1|Participant Flow|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369409|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369410|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369411|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369412|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369413|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369414|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369415|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369449|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369416|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369417|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369418|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369419|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
369420|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
369421|NCT00706550|E2|Reported Event|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
369422|NCT00706550|E1|Reported Event|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
369423|NCT00706485|B1|Baseline|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369424|NCT00706485|P1|Participant Flow|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369425|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369426|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369427|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369428|NCT00706485|E1|Reported Event|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
369429|NCT00706433|B5|Baseline|Total|Total of all reporting groups
369430|NCT00706433|B4|Baseline|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369431|NCT00706433|B3|Baseline|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369432|NCT00706433|B2|Baseline|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369433|NCT00706433|B1|Baseline|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369434|NCT00706433|P4|Participant Flow|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369435|NCT00706433|P3|Participant Flow|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369436|NCT00706433|P2|Participant Flow|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369437|NCT00706433|P1|Participant Flow|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369438|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369439|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369440|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369441|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369442|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369443|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369444|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369445|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369446|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369447|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369448|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369450|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369451|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369452|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369453|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369454|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369455|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369456|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369457|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369458|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369459|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369460|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369461|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369462|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369463|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369464|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369465|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369466|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369467|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369468|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369469|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369470|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369471|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369472|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369473|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369474|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369475|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369476|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369477|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369478|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369479|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369480|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369481|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369482|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369483|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369484|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369485|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369834|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369486|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369487|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369488|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369489|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369490|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369491|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369492|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369493|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369494|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369495|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369496|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369497|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369498|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369499|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369500|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369501|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369502|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369503|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369504|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369505|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369506|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369507|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369508|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369509|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369510|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369511|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369512|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369513|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369514|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369515|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369516|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369517|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369518|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369519|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369520|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369521|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369835|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369522|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369523|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369524|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369525|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369526|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369527|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369528|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369529|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369530|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369531|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369532|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369533|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369534|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369535|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369536|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369537|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369538|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369539|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369540|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369541|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369542|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369543|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369544|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369545|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369546|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369547|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369548|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369549|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369550|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369551|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369552|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369553|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369554|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369555|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369556|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369557|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369836|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369558|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369559|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369560|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369561|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369562|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369563|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369564|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369565|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369566|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369567|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369568|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369569|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369570|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369571|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369572|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369573|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369574|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369575|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369576|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369577|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369578|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369579|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369580|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369581|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369582|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369583|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369584|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369585|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369586|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369587|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369588|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369589|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369590|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369591|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369592|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369593|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369837|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369594|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369595|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369596|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369597|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369598|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369599|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369600|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369601|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369602|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369603|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369604|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369605|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369606|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369607|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369608|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369609|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369610|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369611|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369612|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369613|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369614|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369615|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369616|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369617|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369618|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369619|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369620|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369621|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369622|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369623|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369624|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369625|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369626|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369627|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369628|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369629|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369838|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369630|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369631|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369632|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369633|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369634|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369635|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369636|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369637|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369638|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369639|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369640|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369641|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369642|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369643|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369644|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369645|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369646|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369647|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369648|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369649|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369650|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369651|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369652|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369653|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369654|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369655|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369656|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369657|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369658|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369659|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369660|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369661|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369662|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369663|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369664|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369665|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369839|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369666|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369667|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369668|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369669|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369670|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369671|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369672|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369673|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369674|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369675|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369676|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369677|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369678|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369679|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369680|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369681|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369682|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369683|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369684|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369685|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369686|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369687|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369688|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369689|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369690|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369691|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369692|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369693|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369694|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369695|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369696|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369697|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369698|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369699|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369700|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369701|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369840|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369702|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369703|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369704|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369705|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369706|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369707|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369708|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369709|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369710|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369711|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369712|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369713|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369714|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369715|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369716|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369717|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369718|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369719|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369720|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369721|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369722|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369723|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369724|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369725|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369726|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369727|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369728|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369729|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369730|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369731|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369732|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369733|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369734|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369735|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369736|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369737|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369841|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369738|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369739|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369740|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369741|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369742|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369743|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369744|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369745|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369746|NCT00706433|E4|Reported Event|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
369747|NCT00706433|E3|Reported Event|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369748|NCT00706433|E2|Reported Event|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
369749|NCT00706433|E1|Reported Event|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
369750|NCT00706355|B5|Baseline|Total|Total of all reporting groups
369751|NCT00706355|B4|Baseline|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369752|NCT00706355|B3|Baseline|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369753|NCT00706355|B2|Baseline|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369754|NCT00706355|B1|Baseline|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369755|NCT00706355|P4|Participant Flow|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369756|NCT00706355|P3|Participant Flow|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369757|NCT00706355|P2|Participant Flow|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369758|NCT00706355|P1|Participant Flow|PF-04217903 50 mg|Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles.
369759|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369760|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369761|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369762|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369763|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369764|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369765|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369766|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369767|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369768|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369769|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369770|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369771|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369772|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369773|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369774|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369775|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369776|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369777|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369778|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369779|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369780|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369782|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369783|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369784|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369785|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369786|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369787|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369788|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369789|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369790|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369791|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369792|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369793|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369794|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369795|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369796|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369797|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369798|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369799|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369800|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369801|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369802|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369803|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
369804|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
369805|NCT00706355|E4|Reported Event|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369806|NCT00706355|E3|Reported Event|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369807|NCT00706355|E2|Reported Event|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369808|NCT00706355|E1|Reported Event|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
369809|NCT00706342|B1|Baseline|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369810|NCT00706342|P1|Participant Flow|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369811|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369812|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369813|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369814|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369815|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369816|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369817|NCT00706342|E1|Reported Event|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
369818|NCT00706329|B1|Baseline|Deflux|Treatment with Deflux.
369819|NCT00706329|P1|Participant Flow|Deflux|Treatment with Deflux.
369820|NCT00706329|O1|Outcome|Close Belly Button or Umbilical Hernia|
369821|NCT00706329|E1|Reported Event|Deflux|Treatment with Deflux.
369822|NCT00706134|B5|Baseline|Total|Total of all reporting groups
369823|NCT00706134|B4|Baseline|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369824|NCT00706134|B3|Baseline|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369825|NCT00706134|B2|Baseline|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369826|NCT00706134|B1|Baseline|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369827|NCT00706134|P4|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369828|NCT00706134|P3|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369829|NCT00706134|P2|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369830|NCT00706134|P1|Participant Flow|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369831|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369832|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369833|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
376687|NCT00686998|E2|Reported Event|Placebo|Matching Placebo
369843|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369844|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369845|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369846|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369847|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369848|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369849|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369850|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369851|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369852|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369853|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369854|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369855|NCT00706134|E4|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
369856|NCT00706134|E3|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
369857|NCT00706134|E2|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
369858|NCT00706134|E1|Reported Event|Placebo|Placebo tablet taken once daily in the morning with a light meal.
369859|NCT00706095|B4|Baseline|Total|Total of all reporting groups
369860|NCT00706095|B3|Baseline|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369861|NCT00706095|B2|Baseline|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369862|NCT00706095|B1|Baseline|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369863|NCT00706095|P3|Participant Flow|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369864|NCT00706095|P2|Participant Flow|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369865|NCT00706095|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369866|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369867|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369868|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369869|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369870|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369871|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369872|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369873|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369874|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369875|NCT00706095|E3|Reported Event|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
369876|NCT00706095|E2|Reported Event|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
369877|NCT00706095|E1|Reported Event|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
369878|NCT00706004|B1|Baseline|Lubiprostone|24 micrograms twice daily
369879|NCT00706004|P1|Participant Flow|Lubiprostone|24 micrograms twice daily
369880|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369881|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369882|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369883|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369884|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369885|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369886|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369887|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369888|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369889|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369890|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369891|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369892|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369893|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369894|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369895|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
376688|NCT00686998|E1|Reported Event|AZD2624|AZD2624 40 mg
369896|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369897|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
369898|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
369899|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
369900|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
369901|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
369902|NCT00706004|E1|Reported Event|Lubiprostone|24 micrograms twice daily
369903|NCT00705939|B4|Baseline|Total|Total of all reporting groups
369904|NCT00705939|B3|Baseline|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
369905|NCT00705939|B2|Baseline|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
369906|NCT00705939|B1|Baseline|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369907|NCT00705939|P3|Participant Flow|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
369908|NCT00705939|P2|Participant Flow|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
369909|NCT00705939|P1|Participant Flow|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369910|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
369911|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369912|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369913|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
369914|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369915|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369916|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
369917|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369918|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369919|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
369920|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369921|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369922|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
369923|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369924|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369925|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
369926|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
369927|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369928|NCT00705939|E3|Reported Event|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
369929|NCT00705939|E2|Reported Event|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
369930|NCT00705939|E1|Reported Event|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
369931|NCT00705874|B8|Baseline|Total|Total of all reporting groups
369932|NCT00705874|B7|Baseline|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
369933|NCT00705874|B6|Baseline|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
369934|NCT00705874|B5|Baseline|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
369935|NCT00705874|B4|Baseline|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
369936|NCT00705874|B3|Baseline|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
369937|NCT00705874|B2|Baseline|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
376689|NCT00686959|B3|Baseline|Total|Total of all reporting groups
369938|NCT00705874|B1|Baseline|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
369939|NCT00705874|P7|Participant Flow|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
369940|NCT00705874|P6|Participant Flow|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
369941|NCT00705874|P5|Participant Flow|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
369942|NCT00705874|P4|Participant Flow|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
369943|NCT00705874|P3|Participant Flow|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
369944|NCT00705874|P2|Participant Flow|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
369945|NCT00705874|P1|Participant Flow|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
369946|NCT00705874|O7|Outcome|PG11047/Sunitinib|"PG-11047 in combination with Sunitinib.~The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group"
369947|NCT00705874|O6|Outcome|PG11047/5-Flurouracil|CGC-11047 in combination with 5-Flurouracil / Leucovorin
369948|NCT00705874|O5|Outcome|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
369949|NCT00705874|O4|Outcome|PG11047/Erlotinib|PG-11047 in combination with Erlotinib
369950|NCT00705874|O3|Outcome|PG11047/Bevacizumab|PG-11047 in combination with Bevacizumab
369951|NCT00705874|O2|Outcome|PG11047/Docetaxel|PG-11047 in combination with Docetaxel
369952|NCT00705874|O1|Outcome|PG11047/Gemcitabine|PG-11047 in combination with Gemcitabine
369953|NCT00705874|E7|Reported Event|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
369954|NCT00705874|E6|Reported Event|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
369955|NCT00705874|E5|Reported Event|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
369956|NCT00705874|E4|Reported Event|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
369957|NCT00705874|E3|Reported Event|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
369958|NCT00705874|E2|Reported Event|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
369959|NCT00705874|E1|Reported Event|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
369960|NCT00705783|B3|Baseline|Total|Total of all reporting groups
369961|NCT00705783|B2|Baseline|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369962|NCT00705783|B1|Baseline|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369963|NCT00705783|P3|Participant Flow|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369964|NCT00705783|P2|Participant Flow|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369965|NCT00705783|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
369966|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369967|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369968|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369969|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369970|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369971|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369972|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369973|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369974|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369975|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369976|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369977|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369978|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369979|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369980|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369981|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369982|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369983|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369984|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
369985|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369986|NCT00705783|E5|Reported Event|Placebo Depot - Depot Maintenance Phase|Patients received placebo intramuscularly every 28 days for 52 weeks.
369987|NCT00705783|E4|Reported Event|Aripiprazole Depot - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
369988|NCT00705783|E3|Reported Event|Depot Stabilization Phase|During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
369989|NCT00705783|E2|Reported Event|Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
369990|NCT00705783|E1|Reported Event|Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
369991|NCT00705757|B4|Baseline|Total|Total of all reporting groups
369992|NCT00705757|B3|Baseline|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
369993|NCT00705757|B2|Baseline|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
369994|NCT00705757|B1|Baseline|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
369995|NCT00705757|P3|Participant Flow|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
369996|NCT00705757|P2|Participant Flow|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
369997|NCT00705757|P1|Participant Flow|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
369998|NCT00705757|O3|Outcome|Travatan|Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
369999|NCT00705757|O2|Outcome|Xalatan|Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).
370000|NCT00705757|O1|Outcome|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).
370001|NCT00705757|E3|Reported Event|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
370002|NCT00705757|E2|Reported Event|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
370003|NCT00705757|E1|Reported Event|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
370004|NCT00705718|B3|Baseline|Total|Total of all reporting groups
370005|NCT00705718|B2|Baseline|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370006|NCT00705718|B1|Baseline|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370007|NCT00705718|P2|Participant Flow|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370008|NCT00705718|P1|Participant Flow|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370009|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370010|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370011|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370012|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370013|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370014|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370015|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370016|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370017|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370018|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370019|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
370020|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
370021|NCT00705718|E2|Reported Event|2. Endurant Bifurcated Arm|Endurant Stent Graft System - Endurant Bifurcated arm
370022|NCT00705718|E1|Reported Event|1. Endurant AUI Arm|Endurant Stent Graft System - Endurant AUI arm
370023|NCT00705679|B6|Baseline|Total|Total of all reporting groups
370024|NCT00705679|B5|Baseline|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
370025|NCT00705679|B4|Baseline|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
370026|NCT00705679|B3|Baseline|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370151|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370027|NCT00705679|B2|Baseline|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370028|NCT00705679|B1|Baseline|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
370029|NCT00705679|P5|Participant Flow|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
370030|NCT00705679|P4|Participant Flow|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
370031|NCT00705679|P3|Participant Flow|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370032|NCT00705679|P2|Participant Flow|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370033|NCT00705679|P1|Participant Flow|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
370034|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
370035|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
370036|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370037|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370038|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
370039|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370040|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370041|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370042|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370043|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370044|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370045|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370046|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
370047|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370048|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
370049|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
370050|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
370051|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
370052|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
370053|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
370054|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
370055|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370056|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370057|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
370058|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
370059|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
370060|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
370061|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
370062|NCT00705679|E5|Reported Event|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
370063|NCT00705679|E4|Reported Event|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
370064|NCT00705679|E3|Reported Event|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370065|NCT00705679|E2|Reported Event|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
370066|NCT00705679|E1|Reported Event|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
370067|NCT00705666|B1|Baseline|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
370068|NCT00705666|P1|Participant Flow|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
370069|NCT00705666|O1|Outcome|PegIntron as Monotherapy or in Combination With Ribavirin|"Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.~The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.~The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators."
370070|NCT00705666|E1|Reported Event|PegIntron as Monotherapy or in Combination With Ribavirin|
370071|NCT00705653|B1|Baseline|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
370072|NCT00705653|P1|Participant Flow|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
370073|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
370074|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
370075|NCT00705653|E1|Reported Event|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
370076|NCT00705614|B3|Baseline|Total|Total of all reporting groups
370077|NCT00705614|B2|Baseline|Standard Therapy Group|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
370078|NCT00705614|B1|Baseline|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
370079|NCT00705614|P2|Participant Flow|Standard Therapy Group|"Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.~Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter."
370080|NCT00705614|P1|Participant Flow|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
370081|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370082|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370083|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370084|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370085|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370086|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370087|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370152|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370088|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370089|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370090|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370091|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370092|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370093|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370094|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370095|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370096|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370097|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370098|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370099|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370100|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370101|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370102|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370103|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370104|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370105|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370106|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370107|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370108|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370109|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370110|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370111|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370112|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370113|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370114|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370115|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370116|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370117|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370118|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370119|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370120|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
378147|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
370121|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370122|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370123|NCT00705614|E3|Reported Event|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
370124|NCT00705614|E2|Reported Event|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
370125|NCT00705614|E1|Reported Event|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
370126|NCT00705575|B3|Baseline|Total|Total of all reporting groups
370127|NCT00705575|B2|Baseline|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370128|NCT00705575|B1|Baseline|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370129|NCT00705575|P2|Participant Flow|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370130|NCT00705575|P1|Participant Flow|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370131|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370132|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370133|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370134|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370135|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370136|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370137|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370138|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370139|NCT00705575|E2|Reported Event|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
370140|NCT00705575|E1|Reported Event|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
370141|NCT00705536|B3|Baseline|Total|Total of all reporting groups
370142|NCT00705536|B2|Baseline|Stage 2: Humulin-R Alone or Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone or 20 U Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
370143|NCT00705536|B1|Baseline|Stage 1: Humalog Alone or Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone or 20 U Humalog + 300 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
370144|NCT00705536|P4|Participant Flow|Stage 2: Humulin-R + rHuPH20 First, Then Humulin-R|Stage 2 of the study. A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R alone.
370145|NCT00705536|P3|Participant Flow|Stage 2: Humulin-R First, Then Humulin-R + rHuPH20|Stage 2 of the study: A single subcutaneous (SC) injection of 20 units (U) Humulin-R alone on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20).
370146|NCT00705536|P2|Participant Flow|Stage 1: Humalog + rHuPH20 First, Then Humalog|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog alone.
370147|NCT00705536|P1|Participant Flow|Stage 1: Humalog First, Then Humalog + rHuPH20|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog alone on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20).
370148|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370149|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin: A single subcutaneous (SC) injection of 20 units (U)
370150|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370153|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370154|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370155|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370156|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370157|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370158|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370159|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370160|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370161|NCT00705536|O3|Outcome|Stage 2: Humulin Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370162|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370163|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370164|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370165|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370166|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370167|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370168|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370169|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370170|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370171|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370172|NCT00705536|O2|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humulin-R and 240 U of rHuPH20
370173|NCT00705536|O1|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20
370174|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370175|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370176|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370177|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370178|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370179|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370180|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370181|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370182|NCT00705536|O3|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370183|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370184|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370185|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370186|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370187|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20
370188|NCT00705536|O1|Outcome|Stage 1. Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370189|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370190|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370191|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370192|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370193|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370194|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370195|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370196|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370197|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
370198|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
370199|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
370200|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
370201|NCT00705536|E4|Reported Event|Stage 2: Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20) during Stage 2 of the study
370202|NCT00705536|E3|Reported Event|Stage 2: Humulin-R Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone during Stage 2 of the study
370203|NCT00705536|E2|Reported Event|Stage 1: Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase (rHuPH20) during Stage 1 of the study
370204|NCT00705536|E1|Reported Event|Stage 1: Humalog Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone during Stage 1 of the study
370205|NCT00705523|B3|Baseline|Total|Total of all reporting groups
370206|NCT00705523|B2|Baseline|Placebo|placebo : BID 12 weeks
370207|NCT00705523|B1|Baseline|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
370208|NCT00705523|P2|Participant Flow|Placebo|placebo : BID 12 weeks
370209|NCT00705523|P1|Participant Flow|Varenicline|varenicline : 1.0 mg BID for 12 weeks
370210|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
370211|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
370212|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
370213|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
370214|NCT00705523|E2|Reported Event|Placebo|placebo : BID 12 weeks
370215|NCT00705523|E1|Reported Event|Varenicline|varenicline : 1.0 mg BID for 12 weeks
370216|NCT00705432|B7|Baseline|Total|Total of all reporting groups
370217|NCT00705432|B6|Baseline|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370218|NCT00705432|B5|Baseline|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370219|NCT00705432|B4|Baseline|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370220|NCT00705432|B3|Baseline|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370221|NCT00705432|B2|Baseline|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370222|NCT00705432|B1|Baseline|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370223|NCT00705432|P6|Participant Flow|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370224|NCT00705432|P5|Participant Flow|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370225|NCT00705432|P4|Participant Flow|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370399|NCT00705146|B1|Baseline|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
370226|NCT00705432|P3|Participant Flow|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370227|NCT00705432|P2|Participant Flow|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370228|NCT00705432|P1|Participant Flow|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370229|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370230|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370231|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370232|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370233|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370234|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370235|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370236|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370237|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370238|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370239|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370240|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370241|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370294|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370942|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370242|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370243|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370244|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370245|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370246|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370247|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370248|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370249|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370250|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370251|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370252|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370253|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370254|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370255|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370256|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370295|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370296|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370297|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370298|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370299|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370257|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370258|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370259|NCT00705432|E3|Reported Event|BOCEPRIVIR + PEG + RBV - 44 WEEKS|Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370260|NCT00705432|E2|Reported Event|BOCEPREVIR + PEG + RBV - 24 WEEKS|"Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
370261|NCT00705432|E1|Reported Event|PEG + RBV|Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
370262|NCT00705406|B3|Baseline|Total|Total of all reporting groups
370263|NCT00705406|B2|Baseline|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370264|NCT00705406|B1|Baseline|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370265|NCT00705406|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370266|NCT00705406|P1|Participant Flow|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370267|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370268|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370269|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370270|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370271|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370272|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370273|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370274|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370275|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370276|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370277|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370278|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370279|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection
370280|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370281|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370282|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370283|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370284|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370285|NCT00705406|E2|Reported Event|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
370286|NCT00705406|E1|Reported Event|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
370287|NCT00705367|B3|Baseline|Total|Total of all reporting groups
370288|NCT00705367|B2|Baseline|Placebo|Infusion, Intravenous, single dose, 24 hours
370289|NCT00705367|B1|Baseline|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370290|NCT00705367|P2|Participant Flow|Placebo/Abatacept,10 mg/kg|Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370291|NCT00705367|P1|Participant Flow|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370292|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370293|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370943|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370300|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370301|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370302|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370303|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370304|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370305|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370306|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370307|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370308|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370309|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370310|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
370311|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
370312|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
370313|NCT00705367|E2|Reported Event|Placebo|
370314|NCT00705367|E1|Reported Event|Abatacept 30 mg/kg|
370315|NCT00705341|B3|Baseline|Total|Total of all reporting groups
370316|NCT00705341|B2|Baseline|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370317|NCT00705341|B1|Baseline|Nonasthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370318|NCT00705341|P4|Participant Flow|High Dose, Then Low Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
370319|NCT00705341|P3|Participant Flow|Low Dose, Then High Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
370320|NCT00705341|P2|Participant Flow|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370321|NCT00705341|P1|Participant Flow|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370322|NCT00705341|O2|Outcome|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370323|NCT00705341|O1|Outcome|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
370324|NCT00705341|O2|Outcome|4 Weeks of Low Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
370325|NCT00705341|O1|Outcome|4 Weeks of High Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
370326|NCT00705341|E2|Reported Event|High Dose for Phase 2|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
370327|NCT00705341|E1|Reported Event|Low Dose for phase1|4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
370328|NCT00705289|B1|Baseline|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370329|NCT00705289|P1|Participant Flow|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370330|NCT00705289|O4|Outcome|Established RA, Failed/Did Not Tolerate Another Anti-TNF|Subjects with established RA having failed or not tolerated another anti-TNF.
370331|NCT00705289|O3|Outcome|Established RA, Not Treated With Anti-TNF|Subjects with established RA not yet treated with an anti-TNF.
370332|NCT00705289|O2|Outcome|Early RA, Not Treated With Anti-TNF|Subjects with early RA not yet treated with an anti-TNF.
370333|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370334|NCT00705289|O12|Outcome|Sweden|
370335|NCT00705289|O11|Outcome|Portugal|
370336|NCT00705289|O10|Outcome|Poland|
370337|NCT00705289|O9|Outcome|Norway|
370338|NCT00705289|O8|Outcome|Netherlands|
370339|NCT00705289|O7|Outcome|Italy|
370340|NCT00705289|O6|Outcome|Greece|
370341|NCT00705289|O5|Outcome|Germany|
370342|NCT00705289|O4|Outcome|France|
370343|NCT00705289|O3|Outcome|Denmark|
370344|NCT00705289|O2|Outcome|Belgium|
370345|NCT00705289|O1|Outcome|Austria|
370346|NCT00705289|O3|Outcome|Female|
370347|NCT00705289|O2|Outcome|Male|
370348|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370944|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370349|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370350|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
370351|NCT00705289|E1|Reported Event|Infliximab 3 mg/kg|
370352|NCT00705263|B1|Baseline|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
370353|NCT00705263|P1|Participant Flow|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
370354|NCT00705263|O1|Outcome|Patients Treated With PegIntron Pen Plus Rebetol|
370355|NCT00705263|E1|Reported Event|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
370356|NCT00705250|B1|Baseline|All Participants|
370357|NCT00705250|P1|Participant Flow|All Participants|
370358|NCT00705250|O1|Outcome|All Participants|
370359|NCT00705250|E1|Reported Event|All Participants|
370360|NCT00705224|B1|Baseline|Pegylated Interferon and Ribavirin|"Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
370361|NCT00705224|P1|Participant Flow|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C."
370362|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370363|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370364|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370365|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and a stage of hepatitis C.
370366|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370396|NCT00705159|E1|Reported Event|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370397|NCT00705146|B3|Baseline|Total|Total of all reporting groups
370398|NCT00705146|B2|Baseline|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
370367|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370368|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370369|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370370|NCT00705224|O1|Outcome|Pegylated Interferon and Ribavirin|Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
370371|NCT00705224|E1|Reported Event|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
370372|NCT00705159|B5|Baseline|Total|Total of all reporting groups
370373|NCT00705159|B4|Baseline|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370374|NCT00705159|B3|Baseline|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370375|NCT00705159|B2|Baseline|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370376|NCT00705159|B1|Baseline|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370377|NCT00705159|P4|Participant Flow|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370378|NCT00705159|P3|Participant Flow|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370379|NCT00705159|P2|Participant Flow|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370380|NCT00705159|P1|Participant Flow|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370381|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370382|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370383|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370384|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370385|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370386|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370387|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370388|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370389|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370390|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370391|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370392|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
370393|NCT00705159|E4|Reported Event|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
370394|NCT00705159|E3|Reported Event|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
370395|NCT00705159|E2|Reported Event|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
370400|NCT00705146|P2|Participant Flow|Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
370401|NCT00705146|P1|Participant Flow|Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
370402|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
370403|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
370404|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
370405|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
370406|NCT00705146|E2|Reported Event|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
370407|NCT00705146|E1|Reported Event|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
370408|NCT00705107|B1|Baseline|All Treated Patients|
370409|NCT00705107|P1|Participant Flow|All Treated Patients|
370410|NCT00705107|O1|Outcome|All Treated Patients|
370411|NCT00705107|O1|Outcome|All Treated Patients|
370412|NCT00705107|E1|Reported Event|All Treated Patients|
370413|NCT00705081|B3|Baseline|Total|Total of all reporting groups
370414|NCT00705081|B2|Baseline|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370415|NCT00705081|B1|Baseline|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370416|NCT00705081|P2|Participant Flow|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370417|NCT00705081|P1|Participant Flow|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370418|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370419|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370420|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370421|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370422|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370423|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370424|NCT00705081|E2|Reported Event|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
370425|NCT00705081|E1|Reported Event|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
370426|NCT00705016|B4|Baseline|Total|Total of all reporting groups
370427|NCT00705016|B3|Baseline|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370428|NCT00705016|B2|Baseline|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370429|NCT00705016|B1|Baseline|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370430|NCT00705016|P3|Participant Flow|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370484|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
370431|NCT00705016|P2|Participant Flow|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370432|NCT00705016|P1|Participant Flow|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370433|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370434|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370435|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370436|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370437|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370438|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370439|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370440|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370572|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370441|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370442|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370443|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370444|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370445|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370446|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370447|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370448|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370449|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370450|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
378148|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
370451|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370452|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370453|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370454|NCT00705016|E3|Reported Event|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370455|NCT00705016|E2|Reported Event|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370456|NCT00705016|E1|Reported Event|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
370457|NCT00705003|B4|Baseline|Total|Total of all reporting groups
370458|NCT00705003|B3|Baseline|Placebo|Placebo QD
370459|NCT00705003|B2|Baseline|BCI-024|Buspirone 15 mg QD
370460|NCT00705003|B1|Baseline|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370461|NCT00705003|P3|Participant Flow|Placebo|Matching placebo QD
370462|NCT00705003|P2|Participant Flow|BCI-024 (Buspirone)|1 over-encapsulated tablet of buspirone 15 mg QD
370463|NCT00705003|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
370464|NCT00705003|O3|Outcome|Placebo|Placebo QD
370465|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
370466|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370467|NCT00705003|O3|Outcome|Placebo|Placebo QD
370468|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
370469|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370470|NCT00705003|O3|Outcome|Placebo|Placebo QD
370471|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
370472|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370473|NCT00705003|O3|Outcome|Placebo|Placebo QD
370474|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
370475|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370476|NCT00705003|O3|Outcome|Placebo|Placebo QD
370477|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
370478|NCT00705003|O1|Outcome|BCI-024+BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370479|NCT00705003|E3|Reported Event|Placebo|Placebo QD
370480|NCT00705003|E2|Reported Event|BCI-024|Buspirone 15 mg QD
370481|NCT00705003|E1|Reported Event|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
370482|NCT00704964|B1|Baseline|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
370483|NCT00704964|P1|Participant Flow|All Participants|"Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.~Completers are considered those with documentation who finished the study on time."
378149|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
370485|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
370486|NCT00704964|E1|Reported Event|All Participants|
370487|NCT00704938|B3|Baseline|Total|Total of all reporting groups
370488|NCT00704938|B2|Baseline|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370489|NCT00704938|B1|Baseline|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370490|NCT00704938|P2|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370491|NCT00704938|P1|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370492|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370493|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370494|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370495|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370496|NCT00704938|E2|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370497|NCT00704938|E1|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
370498|NCT00704912|B4|Baseline|Total|Total of all reporting groups
370499|NCT00704912|B3|Baseline|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370500|NCT00704912|B2|Baseline|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370501|NCT00704912|B1|Baseline|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370502|NCT00704912|P3|Participant Flow|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370503|NCT00704912|P2|Participant Flow|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370504|NCT00704912|P1|Participant Flow|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370505|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370506|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370507|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370508|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370509|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370510|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370511|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370512|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370513|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370514|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370515|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370516|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370517|NCT00704912|E3|Reported Event|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
370518|NCT00704912|E2|Reported Event|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
370945|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370519|NCT00704912|E1|Reported Event|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
370520|NCT00704847|B3|Baseline|Total|Total of all reporting groups
370521|NCT00704847|B2|Baseline|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
370522|NCT00704847|B1|Baseline|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
370523|NCT00704847|P2|Participant Flow|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
370524|NCT00704847|P1|Participant Flow|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
370525|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
370526|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
370527|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
370528|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
370529|NCT00704847|E2|Reported Event|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
370530|NCT00704847|E1|Reported Event|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
370531|NCT00704808|B1|Baseline|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
370532|NCT00704808|P1|Participant Flow|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
370533|NCT00704808|O1|Outcome|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
370534|NCT00704808|E1|Reported Event|Temozolomide|
370535|NCT00704769|B1|Baseline|Desloratadine|
370536|NCT00704769|P1|Participant Flow|Desloratadine|
370537|NCT00704769|O1|Outcome|Desloratadine|
370538|NCT00704769|O1|Outcome|Desloratadine|
370539|NCT00704769|E1|Reported Event|Desloratadine|
370540|NCT00704730|B3|Baseline|Total|Total of all reporting groups
370541|NCT00704730|B2|Baseline|Placebo|oral capsules once daily
370542|NCT00704730|B1|Baseline|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370543|NCT00704730|P2|Participant Flow|Placebo|oral capsules once daily
370544|NCT00704730|P1|Participant Flow|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370545|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370546|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370547|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370548|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370549|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370550|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370551|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370552|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370553|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370554|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370555|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
370556|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
370557|NCT00704730|E2|Reported Event|Placebo|oral capsules once daily
370558|NCT00704730|E1|Reported Event|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
370559|NCT00704717|B1|Baseline|All Treated Patients|All patients participating in the study.
370560|NCT00704717|P1|Participant Flow|All Treated Patients|All patients participating in the study.
370561|NCT00704717|O1|Outcome|All Treated Patients|All patients participating in the study.
370562|NCT00704717|E1|Reported Event|All Treated Patients|All patients participating in the study.
370563|NCT00704535|B1|Baseline|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370564|NCT00704535|P1|Participant Flow|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370565|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370566|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370567|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370568|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370569|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370570|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370571|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370946|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370573|NCT00704535|E1|Reported Event|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
370574|NCT00704522|B3|Baseline|Total|Total of all reporting groups
370575|NCT00704522|B2|Baseline|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
370576|NCT00704522|B1|Baseline|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
370577|NCT00704522|P2|Participant Flow|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
370578|NCT00704522|P1|Participant Flow|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
370579|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
370580|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
370581|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
370582|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
370583|NCT00704522|E1|Reported Event|PegIntron Pen/Rebetol|
370584|NCT00704418|B3|Baseline|Total|Total of all reporting groups
370585|NCT00704418|B2|Baseline|Placebo|Placebo, dosed 1 drop daily
370586|NCT00704418|B1|Baseline|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
370587|NCT00704418|P2|Participant Flow|Placebo|Placebo, dosed 1 drop daily
370588|NCT00704418|P1|Participant Flow|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
370589|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
370590|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
370591|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
370592|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
370593|NCT00704418|E2|Reported Event|Placebo|Placebo, dosed 1 drop daily
370594|NCT00704418|E1|Reported Event|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
370595|NCT00704405|B6|Baseline|Total|Total of all reporting groups
370596|NCT00704405|B5|Baseline|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370597|NCT00704405|B4|Baseline|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370598|NCT00704405|B3|Baseline|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370599|NCT00704405|B2|Baseline|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370600|NCT00704405|B1|Baseline|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
370601|NCT00704405|P5|Participant Flow|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370602|NCT00704405|P4|Participant Flow|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370603|NCT00704405|P3|Participant Flow|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370604|NCT00704405|P2|Participant Flow|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370605|NCT00704405|P1|Participant Flow|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
370606|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370607|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
370608|NCT00704405|O3|Outcome|PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370609|NCT00704405|O2|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370610|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
370611|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370612|NCT00704405|O1|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370613|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370614|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370615|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370616|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370617|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
370618|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370619|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370620|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370621|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370622|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
370623|NCT00704405|O4|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370624|NCT00704405|O3|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370625|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370626|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
370627|NCT00704405|E5|Reported Event|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
370628|NCT00704405|E4|Reported Event|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370629|NCT00704405|E3|Reported Event|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
370630|NCT00704405|E2|Reported Event|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
370631|NCT00704405|E1|Reported Event|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
370632|NCT00704379|B3|Baseline|Total|Total of all reporting groups
370633|NCT00704379|B2|Baseline|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370634|NCT00704379|B1|Baseline|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370635|NCT00704379|P2|Participant Flow|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370636|NCT00704379|P1|Participant Flow|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370637|NCT00704379|O2|Outcome|Patients Who Did Not Developped a Mood or Anxiety Disorder|
370638|NCT00704379|O1|Outcome|Patients Who Developped a Mood or Anxiety Disorder|
370639|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370640|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370641|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370642|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370643|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370644|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370645|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370646|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370647|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370648|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370649|NCT00704379|E2|Reported Event|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
370650|NCT00704379|E1|Reported Event|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
370651|NCT00704353|B3|Baseline|Total|Total of all reporting groups
370652|NCT00704353|B2|Baseline|Standard Medical Care|Per product label
370653|NCT00704353|B1|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
370654|NCT00704353|P2|Participant Flow|Standard Medical Care|Per product label
370655|NCT00704353|P1|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
370656|NCT00704353|O2|Outcome|Standard Medical Care|Per product label
370657|NCT00704353|O1|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
370658|NCT00704353|E2|Reported Event|Standard Medical Care|Per product label
370659|NCT00704353|E1|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
370660|NCT00704340|B3|Baseline|Total|Total of all reporting groups
370661|NCT00704340|B2|Baseline|Control|Standard of Care (control)
370662|NCT00704340|B1|Baseline|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370663|NCT00704340|P2|Participant Flow|Control|Standard of Care (control)
370664|NCT00704340|P1|Participant Flow|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370665|NCT00704340|O2|Outcome|Control|Standard of Care (control)
370666|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370667|NCT00704340|O2|Outcome|Control|Standard of Care (control)
370668|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370669|NCT00704340|O2|Outcome|Control|Standard of Care (control)
370670|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370671|NCT00704340|E2|Reported Event|Control|Standard of Care (control)
370672|NCT00704340|E1|Reported Event|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
370673|NCT00704184|B6|Baseline|Total|Total of all reporting groups
370674|NCT00704184|B5|Baseline|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370675|NCT00704184|B4|Baseline|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370676|NCT00704184|B3|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370677|NCT00704184|B2|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370678|NCT00704184|B1|Baseline|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370679|NCT00704184|P5|Participant Flow|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370680|NCT00704184|P4|Participant Flow|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370681|NCT00704184|P3|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370682|NCT00704184|P2|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370683|NCT00704184|P1|Participant Flow|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370684|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370685|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370686|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370687|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370688|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370689|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370690|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370691|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370692|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370693|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370694|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370695|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370696|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370697|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370698|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370699|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370700|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370701|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370702|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370703|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370704|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370705|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370706|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370707|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370708|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370709|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370710|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370711|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370712|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370713|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370714|NCT00704184|E5|Reported Event|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370715|NCT00704184|E4|Reported Event|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370716|NCT00704184|E3|Reported Event|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370717|NCT00704184|E2|Reported Event|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370718|NCT00704184|E1|Reported Event|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
370719|NCT00704171|B3|Baseline|Total|Total of all reporting groups
370720|NCT00704171|B2|Baseline|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370721|NCT00704171|B1|Baseline|PleuraSeal|PleuraSeal Lung Sealant System
370722|NCT00704171|P2|Participant Flow|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370723|NCT00704171|P1|Participant Flow|PleuraSeal|PleuraSeal Lung Sealant System
370724|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370725|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370726|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370727|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370728|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370729|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370730|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370731|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370732|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370733|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370734|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370735|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
370736|NCT00704171|E2|Reported Event|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
370737|NCT00704171|E1|Reported Event|PleuraSeal|PleuraSeal Lung Sealant System
370738|NCT00704132|B3|Baseline|Total|Total of all reporting groups
370739|NCT00704132|B2|Baseline|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
370740|NCT00704132|B1|Baseline|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
370741|NCT00704132|P2|Participant Flow|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
370742|NCT00704132|P1|Participant Flow|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
370743|NCT00704132|O2|Outcome|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
370744|NCT00704132|O1|Outcome|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
370745|NCT00704132|E2|Reported Event|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
370746|NCT00704132|E1|Reported Event|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
370747|NCT00704028|B3|Baseline|Total|Total of all reporting groups
370748|NCT00704028|B2|Baseline|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
370749|NCT00704028|B1|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
370750|NCT00704028|P2|Participant Flow|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
370751|NCT00704028|P1|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
370752|NCT00704028|O2|Outcome|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
370753|NCT00704028|O1|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
370754|NCT00704028|E2|Reported Event|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
370755|NCT00704028|E1|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
370756|NCT00703963|B3|Baseline|Total|Total of all reporting groups
370757|NCT00703963|B2|Baseline|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370758|NCT00703963|B1|Baseline|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370759|NCT00703963|P2|Participant Flow|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370760|NCT00703963|P1|Participant Flow|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370947|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370761|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370762|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370763|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370764|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370765|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370766|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370767|NCT00703963|E2|Reported Event|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
370768|NCT00703963|E1|Reported Event|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
370769|NCT00703937|B3|Baseline|Total|Total of all reporting groups
370770|NCT00703937|B2|Baseline|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
370771|NCT00703937|B1|Baseline|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
370772|NCT00703937|P2|Participant Flow|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
370773|NCT00703937|P1|Participant Flow|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
370774|NCT00703937|O2|Outcome|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
370775|NCT00703937|O1|Outcome|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
370776|NCT00703937|E2|Reported Event|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
370777|NCT00703937|E1|Reported Event|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
370778|NCT00703924|B3|Baseline|Total|Total of all reporting groups
370779|NCT00703924|B2|Baseline|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370780|NCT00703924|B1|Baseline|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370781|NCT00703924|P2|Participant Flow|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370782|NCT00703924|P1|Participant Flow|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370783|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370784|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370785|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370786|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370787|NCT00703924|O4|Outcome|Day 180 (+7 Days)|100% Re-epithelialization by day 180 (+7 days)
370788|NCT00703924|O3|Outcome|Day 100|100% Re-epithelialization by day 100
370789|NCT00703924|O2|Outcome|Day 50|100% Re-epithelialization by day 50
370790|NCT00703924|O1|Outcome|Day 20|100% Re-epithelialization by day 20
378150|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
370791|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370792|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370793|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370794|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370795|NCT00703924|E2|Reported Event|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
370796|NCT00703924|E1|Reported Event|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
370797|NCT00703911|B1|Baseline|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370798|NCT00703911|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370799|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370800|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370801|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370802|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370803|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370804|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370805|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370806|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370807|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370808|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370809|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370810|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370811|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370812|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370813|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370814|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370815|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
378151|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
370816|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370817|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370818|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370819|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370820|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370821|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370822|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370823|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370824|NCT00703911|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
370825|NCT00703885|B1|Baseline|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Please note that this is a cross-over design with all subjects receiving all three treatments"
370826|NCT00703885|P1|Participant Flow|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Sequence of administration not available for subjects"
370827|NCT00703885|O1|Outcome|Imaging Data for Repeated Measures|"Crossover design. Each subject receives, in randomized order and on different days:~Low dose alprazolam High dose alprazolam Placebo"
370828|NCT00703885|O1|Outcome|BOLD fMRI|Cross-over design. Each subject receives, on alternate days and in randomized fashion, either low dose, high dose, or placebo
370829|NCT00703885|E1|Reported Event|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|Alprazolam Low Dose Alprazolam High Dose Placebo
370830|NCT00703846|B1|Baseline|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370831|NCT00703846|P1|Participant Flow|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
370832|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370833|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370834|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370835|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370836|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370837|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370838|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370839|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370948|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370949|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370840|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370841|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370842|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370843|NCT00703846|E1|Reported Event|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
370844|NCT00703781|B3|Baseline|Total|Total of all reporting groups
370845|NCT00703781|B2|Baseline|Placebo|Placebo, Dosed 1 Drop Daily
370846|NCT00703781|B1|Baseline|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
370847|NCT00703781|P2|Participant Flow|Placebo|Placebo, Dosed 1 Drop Daily
370848|NCT00703781|P1|Participant Flow|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
370849|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
370850|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
370851|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
370852|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
370853|NCT00703781|E2|Reported Event|Placebo|Placebo, Dosed 1 Drop Daily
370854|NCT00703781|E1|Reported Event|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
370855|NCT00703729|B3|Baseline|Total|Total of all reporting groups
370856|NCT00703729|B2|Baseline|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370857|NCT00703729|B1|Baseline|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370858|NCT00703729|P2|Participant Flow|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370859|NCT00703729|P1|Participant Flow|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370860|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370861|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370892|NCT00703677|B1|Baseline|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370950|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370862|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370863|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370864|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370865|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370866|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370867|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370868|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370869|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370870|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370871|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370872|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370873|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370874|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370875|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370876|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370877|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370878|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370879|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370880|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370881|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370882|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370883|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370884|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370885|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370886|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370887|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370888|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370889|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370890|NCT00703729|E2|Reported Event|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370891|NCT00703729|E1|Reported Event|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
370893|NCT00703677|P1|Participant Flow|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370894|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370895|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370896|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370897|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370898|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370899|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370900|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370901|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370902|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370903|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370904|NCT00703677|E1|Reported Event|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
370905|NCT00703534|B3|Baseline|Total|Total of all reporting groups
370906|NCT00703534|B2|Baseline|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
370907|NCT00703534|B1|Baseline|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
370908|NCT00703534|P2|Participant Flow|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
370909|NCT00703534|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
370910|NCT00703534|O2|Outcome|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
370911|NCT00703534|O1|Outcome|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
370912|NCT00703534|E2|Reported Event|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
370913|NCT00703534|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
370914|NCT00703391|B3|Baseline|Total|Total of all reporting groups
370915|NCT00703391|B2|Baseline|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370916|NCT00703391|B1|Baseline|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370917|NCT00703391|P2|Participant Flow|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370918|NCT00703391|P1|Participant Flow|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370919|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370920|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370921|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370922|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370923|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370924|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370925|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370926|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370927|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370928|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370929|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370930|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370931|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370932|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370933|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370934|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370935|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370936|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370937|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370938|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370939|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370940|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370941|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370951|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370952|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370953|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370954|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370955|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370956|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370957|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370958|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370959|NCT00703391|E2|Reported Event|Placebo|Matched placebo tablets twice daily (bid) for 14 days
370960|NCT00703391|E1|Reported Event|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
370961|NCT00703339|B1|Baseline|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
370962|NCT00703339|P1|Participant Flow|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
370963|NCT00703339|O1|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
370964|NCT00703339|E1|Reported Event|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
370965|NCT00703326|B3|Baseline|Total|Total of all reporting groups
370966|NCT00703326|B2|Baseline|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370967|NCT00703326|B1|Baseline|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370968|NCT00703326|P2|Participant Flow|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370969|NCT00703326|P1|Participant Flow|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370970|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day~1 of each 21-day cycle."
370971|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370972|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370973|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370974|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370975|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370976|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370977|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
371519|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
370978|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370979|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370980|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370981|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370982|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370983|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370984|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370985|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370986|NCT00703326|E2|Reported Event|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370987|NCT00703326|E1|Reported Event|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
370988|NCT00703261|B3|Baseline|Total|Total of all reporting groups
370989|NCT00703261|B2|Baseline|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370990|NCT00703261|B1|Baseline|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370991|NCT00703261|P2|Participant Flow|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370992|NCT00703261|P1|Participant Flow|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370993|NCT00703261|O1|Outcome|Statin-Naive Participants|Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
370994|NCT00703261|O2|Outcome|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
370995|NCT00703261|O1|Outcome|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
370996|NCT00703261|E2|Reported Event|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370997|NCT00703261|E1|Reported Event|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
370998|NCT00703118|B4|Baseline|Total|Total of all reporting groups
370999|NCT00703118|B3|Baseline|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371000|NCT00703118|B2|Baseline|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371001|NCT00703118|B1|Baseline|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371002|NCT00703118|P3|Participant Flow|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371003|NCT00703118|P2|Participant Flow|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371004|NCT00703118|P1|Participant Flow|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371005|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371006|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371007|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371008|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
378152|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
371009|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371010|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371011|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371012|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371013|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371014|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371015|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371016|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371017|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371018|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371019|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371020|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371021|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371022|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371023|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371024|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371025|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371026|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371027|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
371028|NCT00703118|E6|Reported Event|Pbo/PR48 - OVERALL TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
371029|NCT00703118|E5|Reported Event|T12(DS)/PR48 - OVERALL TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
371030|NCT00703118|E4|Reported Event|T12/PR48 - OVERALL TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
371031|NCT00703118|E3|Reported Event|Pbo/PR48 - TVR/PBO TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
371032|NCT00703118|E2|Reported Event|T12(DS)/PR48 - TVR/PBO TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
371033|NCT00703118|E1|Reported Event|T12/PR48 - TVR/PBO TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
371034|NCT00703092|B1|Baseline|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
371035|NCT00703092|P1|Participant Flow|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
371036|NCT00703092|O1|Outcome|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
371037|NCT00703092|E1|Reported Event|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
371038|NCT00703053|B10|Baseline|Total|Total of all reporting groups
371039|NCT00703053|B9|Baseline|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371040|NCT00703053|B8|Baseline|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371041|NCT00703053|B7|Baseline|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371042|NCT00703053|B6|Baseline|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371043|NCT00703053|B5|Baseline|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371044|NCT00703053|B4|Baseline|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371532|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371045|NCT00703053|B3|Baseline|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371046|NCT00703053|B2|Baseline|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371047|NCT00703053|B1|Baseline|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371048|NCT00703053|P9|Participant Flow|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371049|NCT00703053|P8|Participant Flow|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371050|NCT00703053|P7|Participant Flow|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371051|NCT00703053|P6|Participant Flow|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371052|NCT00703053|P5|Participant Flow|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371053|NCT00703053|P4|Participant Flow|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371054|NCT00703053|P3|Participant Flow|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371055|NCT00703053|P2|Participant Flow|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371056|NCT00703053|P1|Participant Flow|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371057|NCT00703053|O3|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371058|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371059|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371060|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371061|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371062|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371063|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371064|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371065|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371066|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371067|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371068|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371069|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371070|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371520|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371071|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371072|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371073|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371074|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371075|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371076|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371077|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371078|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371079|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371080|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371081|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371082|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371083|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371084|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371085|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371086|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371087|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371088|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371089|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371090|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371091|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371092|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371093|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371094|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371095|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371521|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371096|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371097|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371098|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371099|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371100|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371101|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371102|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371103|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371104|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371105|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371106|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371107|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371108|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371109|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371110|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371111|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371112|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371113|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371114|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371115|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371116|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371117|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371118|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371119|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371120|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371121|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371122|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371123|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371124|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371125|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371126|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371127|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371128|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371129|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371130|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371131|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371132|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371133|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371134|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371135|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371136|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371137|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371138|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371139|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371140|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371141|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371142|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371143|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371144|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371145|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371146|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371147|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371148|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371149|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371150|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371151|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371152|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371153|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371154|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371155|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371156|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371157|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371158|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371159|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371160|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371161|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371162|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371163|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371164|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371165|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371166|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371167|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371168|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371169|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371170|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371171|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371172|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371173|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371174|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371175|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371176|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371177|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371178|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371179|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371180|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371181|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371182|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371183|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371184|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371185|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371186|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371187|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371188|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371189|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371190|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371191|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371192|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371193|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371194|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371195|NCT00703053|O8|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371196|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371197|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371198|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371522|NCT00702377|E2|Reported Event|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371199|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371200|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371201|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371202|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371203|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371204|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371205|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371206|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371207|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371208|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371209|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371210|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371211|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371212|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371213|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371214|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371215|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371216|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371217|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371218|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371219|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371220|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371221|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371222|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371223|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371224|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371296|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371225|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371226|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371227|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371228|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371229|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371230|NCT00703053|E9|Reported Event|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371231|NCT00703053|E8|Reported Event|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371232|NCT00703053|E7|Reported Event|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371233|NCT00703053|E6|Reported Event|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371234|NCT00703053|E5|Reported Event|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
371235|NCT00703053|E4|Reported Event|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371236|NCT00703053|E3|Reported Event|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
371237|NCT00703053|E2|Reported Event|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371238|NCT00703053|E1|Reported Event|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
371239|NCT00703014|B3|Baseline|Total|Total of all reporting groups
371240|NCT00703014|B2|Baseline|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371241|NCT00703014|B1|Baseline|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371242|NCT00703014|P4|Participant Flow|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
371243|NCT00703014|P3|Participant Flow|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
371244|NCT00703014|P2|Participant Flow|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371297|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371245|NCT00703014|P1|Participant Flow|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371246|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371247|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371248|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371249|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371250|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
371251|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
371252|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
371253|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
371254|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371255|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371256|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371533|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
371257|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371258|NCT00703014|E4|Reported Event|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
371259|NCT00703014|E3|Reported Event|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
371260|NCT00703014|E2|Reported Event|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371261|NCT00703014|E1|Reported Event|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
371262|NCT00702949|B4|Baseline|Total|Total of all reporting groups
371263|NCT00702949|B3|Baseline|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371264|NCT00702949|B2|Baseline|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371265|NCT00702949|B1|Baseline|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371266|NCT00702949|P3|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371267|NCT00702949|P2|Participant Flow|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371268|NCT00702949|P1|Participant Flow|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371269|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371270|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371271|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371272|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371273|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371274|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371275|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371276|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371277|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371278|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371279|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371280|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371281|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371282|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371283|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371284|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371285|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371286|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371287|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371288|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371289|NCT00702949|E3|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 weeks.
371290|NCT00702949|E2|Reported Event|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
371291|NCT00702949|E1|Reported Event|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
371292|NCT00702923|B1|Baseline|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
371293|NCT00702923|P1|Participant Flow|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
371294|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371295|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371298|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371299|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
371300|NCT00702923|E1|Reported Event|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
371301|NCT00702845|B3|Baseline|Total|Total of all reporting groups
371302|NCT00702845|B2|Baseline|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371303|NCT00702845|B1|Baseline|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371304|NCT00702845|P2|Participant Flow|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371305|NCT00702845|P1|Participant Flow|100 μg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
371306|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371307|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371308|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371309|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371373|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371374|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
371310|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371311|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371312|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371313|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371314|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371315|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371316|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371317|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371318|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371319|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371523|NCT00702377|E1|Reported Event|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371320|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371321|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371322|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371323|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371324|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371325|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371326|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371327|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371328|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371329|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371524|NCT00702364|B3|Baseline|Total|Total of all reporting groups
371330|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371331|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371332|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371333|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371334|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371335|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371336|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371337|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371338|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371339|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371525|NCT00702364|B2|Baseline|Placebo|"Placebo twice a day for two weeks~placebo :"
371340|NCT00702845|E2|Reported Event|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
371341|NCT00702845|E1|Reported Event|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
371342|NCT00702780|B3|Baseline|Total|Total of all reporting groups
371343|NCT00702780|B2|Baseline|Placebo|placebo 20mg qd
371344|NCT00702780|B1|Baseline|Escitalopram|escitalopram 20mg qd
371345|NCT00702780|P2|Participant Flow|Placebo|placebo 20mg qd
371346|NCT00702780|P1|Participant Flow|Escitalopram|escitalopram 20mg qd
371347|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
371348|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
371349|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
371350|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
371351|NCT00702780|E2|Reported Event|Placebo|Placebo 20mg qd
371352|NCT00702780|E1|Reported Event|Escitalopram|Escitalopram 20mg qd
371353|NCT00702754|B1|Baseline|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371354|NCT00702754|P1|Participant Flow|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371355|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371356|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371357|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371358|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371359|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371360|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371361|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371362|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371363|NCT00702754|E1|Reported Event|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
371364|NCT00702715|B3|Baseline|Total|Total of all reporting groups
371365|NCT00702715|B2|Baseline|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371366|NCT00702715|B1|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
371367|NCT00702715|P2|Participant Flow|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371368|NCT00702715|P1|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
371369|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371370|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
371371|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371372|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
371526|NCT00702364|B1|Baseline|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371527|NCT00702364|P2|Participant Flow|Placebo|"Placebo twice a day for two weeks~placebo :"
371375|NCT00702715|E2|Reported Event|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
371376|NCT00702715|E1|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
371377|NCT00702702|B4|Baseline|Total|Total of all reporting groups
371378|NCT00702702|B3|Baseline|Placebo|Placebo, 2 placebo capsules daily for 3 months
371379|NCT00702702|B2|Baseline|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
371380|NCT00702702|B1|Baseline|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
371381|NCT00702702|P1|Participant Flow|All Groups|Proellex 25 mg, 50 mg or placebo
371382|NCT00702702|O3|Outcome|Placebo|Placebo, 2 placebo capsules daily for 3 months
371383|NCT00702702|O2|Outcome|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
371384|NCT00702702|O1|Outcome|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
371385|NCT00702702|E3|Reported Event|C Placebo|Placebo, 2 capsules daily for 3 months
371386|NCT00702702|E2|Reported Event|B 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
371387|NCT00702702|E1|Reported Event|A 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
371388|NCT00702689|B1|Baseline|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
371389|NCT00702689|P1|Participant Flow|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
371390|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
371391|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
371392|NCT00702689|E1|Reported Event|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
371393|NCT00702650|B1|Baseline|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371394|NCT00702650|P1|Participant Flow|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371395|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371396|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371397|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371398|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371399|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371400|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371401|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371402|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371403|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371404|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371405|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371406|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371407|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371408|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371409|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371410|NCT00702650|E1|Reported Event|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
371411|NCT00702624|B3|Baseline|Total|Total of all reporting groups
371466|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371528|NCT00702364|P1|Participant Flow|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371412|NCT00702624|B2|Baseline|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371413|NCT00702624|B1|Baseline|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371414|NCT00702624|P4|Participant Flow|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
371415|NCT00702624|P3|Participant Flow|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
371416|NCT00702624|P2|Participant Flow|recFSH 150 IU Women/Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371417|NCT00702624|P1|Participant Flow|Corifollitropin Alfa 100 μg Women/Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371418|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
371419|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
371420|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
371421|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
371422|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371423|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371529|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
371530|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371424|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371425|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371426|NCT00702624|O2|Outcome|recFSH 150 IU Women|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371427|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Women|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371428|NCT00702624|E4|Reported Event|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
371429|NCT00702624|E3|Reported Event|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
371430|NCT00702624|E2|Reported Event|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
371431|NCT00702624|E1|Reported Event|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
371432|NCT00702546|B3|Baseline|Total|Total of all reporting groups
371433|NCT00702546|B2|Baseline|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371467|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
371531|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
371434|NCT00702546|B1|Baseline|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371435|NCT00702546|P2|Participant Flow|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371436|NCT00702546|P1|Participant Flow|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371437|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371438|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371439|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371440|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371441|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371442|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371443|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371444|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371445|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371446|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371447|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371448|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371449|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371517|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
378153|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
371450|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371451|NCT00702546|E2|Reported Event|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371452|NCT00702546|E1|Reported Event|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
371453|NCT00702520|B3|Baseline|Total|Total of all reporting groups
371454|NCT00702520|B2|Baseline|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371455|NCT00702520|B1|Baseline|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
371456|NCT00702520|P4|Participant Flow|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371457|NCT00702520|P3|Participant Flow|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371458|NCT00702520|P2|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371459|NCT00702520|P1|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
371460|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371461|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
371462|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371463|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371464|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371465|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
371518|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371468|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371469|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
371470|NCT00702520|E4|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug|Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
371471|NCT00702520|E3|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug|Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
371472|NCT00702520|E2|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
371473|NCT00702520|E1|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
371474|NCT00702507|B1|Baseline|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371475|NCT00702507|P1|Participant Flow|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371476|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371477|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371478|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371479|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371480|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371481|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371482|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371483|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
371484|NCT00702507|E2|Reported Event|Vusion Follow-up Phase|After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate.
371485|NCT00702507|E1|Reported Event|Vusion Initial Treatment Phase|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14.
371486|NCT00702468|B3|Baseline|Total|Total of all reporting groups
371487|NCT00702468|B2|Baseline|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
378154|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
371488|NCT00702468|B1|Baseline|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371489|NCT00702468|P2|Participant Flow|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371490|NCT00702468|P1|Participant Flow|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371491|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371492|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371493|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371494|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371495|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371496|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371497|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371498|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371499|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371500|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371501|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371502|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371503|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371504|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371505|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371506|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371507|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371508|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371509|NCT00702468|E2|Reported Event|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
371510|NCT00702468|E1|Reported Event|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
371511|NCT00702377|B3|Baseline|Total|Total of all reporting groups
371512|NCT00702377|B2|Baseline|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371513|NCT00702377|B1|Baseline|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371514|NCT00702377|P2|Participant Flow|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371515|NCT00702377|P1|Participant Flow|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371516|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
371534|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371535|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
371536|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371537|NCT00702364|E2|Reported Event|Placebo|"Placebo twice a day for two weeks~placebo :"
371538|NCT00702364|E1|Reported Event|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
371539|NCT00702338|B1|Baseline|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371540|NCT00702338|P3|Participant Flow|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
371541|NCT00702338|P2|Participant Flow|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371542|NCT00702338|P1|Participant Flow|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
371543|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers from study P05693 (NCT00697255) were followed for safety and efficacy on the current study according to standard practice.
371544|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
371545|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371546|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
371547|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371548|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
371549|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371585|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371586|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371550|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
371551|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371552|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
371553|NCT00702338|E2|Reported Event|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
371554|NCT00702338|E1|Reported Event|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
371555|NCT00702325|B3|Baseline|Total|Total of all reporting groups
371556|NCT00702325|B2|Baseline|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371557|NCT00702325|B1|Baseline|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371558|NCT00702325|P2|Participant Flow|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371559|NCT00702325|P1|Participant Flow|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371560|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371561|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371562|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371563|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371564|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371565|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371566|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371567|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371568|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371569|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371570|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371571|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371572|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371573|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371574|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371575|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371576|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371577|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371578|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371579|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371580|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371581|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371582|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371583|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371584|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371587|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371588|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371589|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371590|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371591|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371592|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371593|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371594|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371595|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371596|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371597|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371598|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371599|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371600|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371601|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371602|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371603|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371604|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371605|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371606|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371607|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371608|NCT00702325|E2|Reported Event|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
371609|NCT00702325|E1|Reported Event|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
371610|NCT00702299|B1|Baseline|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371611|NCT00702299|P1|Participant Flow|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371612|NCT00702299|O3|Outcome|Pemetrexed Dose 1,000mg/m2|Level 5 Pemetrexed dose 1,000mg/m2
371613|NCT00702299|O2|Outcome|Pemetrexed Dose 750 mg/m2|Level 4 Pemetrexed dose 750 mg/m2
371614|NCT00702299|O1|Outcome|Pemetrexed Dose 500mg/m2|Level 3 Pemetrexed dose 500mg/m2
371615|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371616|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371617|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371618|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371619|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371620|NCT00702299|E1|Reported Event|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
371621|NCT00702273|B3|Baseline|Total|Total of all reporting groups
371622|NCT00702273|B2|Baseline|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371623|NCT00702273|B1|Baseline|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371683|NCT00702143|E1|Reported Event|All Subjects|All subjects receiving florbetapir F 18 injection
371684|NCT00701935|B3|Baseline|Total|Total of all reporting groups
371624|NCT00702273|P2|Participant Flow|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371625|NCT00702273|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
371626|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371627|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371628|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371629|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371630|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371631|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371632|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371685|NCT00701935|B2|Baseline|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371686|NCT00701935|B1|Baseline|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371687|NCT00701935|P2|Participant Flow|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371825|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371633|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371634|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371635|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371636|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371637|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371638|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371639|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371640|NCT00702273|E2|Reported Event|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371641|NCT00702273|E1|Reported Event|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
371688|NCT00701935|P1|Participant Flow|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371689|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371690|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371642|NCT00702234|B1|Baseline|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371643|NCT00702234|P2|Participant Flow|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
371644|NCT00702234|P1|Participant Flow|Women/Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371645|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
371646|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
371647|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371648|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371649|NCT00702234|O1|Outcome|Women - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371650|NCT00702234|E2|Reported Event|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
371691|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371692|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371693|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371694|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371695|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
378155|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
371651|NCT00702234|E1|Reported Event|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
371652|NCT00702221|B3|Baseline|Total|Total of all reporting groups
371653|NCT00702221|B2|Baseline|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371654|NCT00702221|B1|Baseline|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371655|NCT00702221|P2|Participant Flow|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371656|NCT00702221|P1|Participant Flow|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371657|NCT00702221|O2|Outcome|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371658|NCT00702221|O1|Outcome|Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371659|NCT00702221|E2|Reported Event|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371660|NCT00702221|E1|Reported Event|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
371661|NCT00702208|B1|Baseline|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
371662|NCT00702208|P1|Participant Flow|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
371663|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
371664|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
371665|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
371666|NCT00702208|E1|Reported Event|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
371667|NCT00702143|B4|Baseline|Total|Total of all reporting groups
371668|NCT00702143|B3|Baseline|Healthy Controls|cognitively normal (healthy) controls
371669|NCT00702143|B2|Baseline|MCI Subjects|MCI (mild cognitive impairment)
371670|NCT00702143|B1|Baseline|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
371671|NCT00702143|P3|Participant Flow|Healthy Controls|cognitively normal (healthy) controls
371672|NCT00702143|P2|Participant Flow|MCI Subjects|MCI (mild cognitive impairment)
371673|NCT00702143|P1|Participant Flow|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
371674|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
371675|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
371676|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
371677|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
371678|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
371679|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
371680|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
371681|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
371682|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
371696|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371697|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371698|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371699|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371700|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371701|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371702|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371703|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371704|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371705|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371706|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371707|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371708|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371709|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371710|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371711|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371712|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371713|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371714|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371715|NCT00701935|E2|Reported Event|Placebo|Subcutaneous injection of placebo twice a day for 6 months
371716|NCT00701935|E1|Reported Event|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
371717|NCT00701805|B5|Baseline|Total|Total of all reporting groups
371718|NCT00701805|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371719|NCT00701805|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371720|NCT00701805|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371721|NCT00701805|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371722|NCT00701805|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371723|NCT00701805|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371724|NCT00701805|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371823|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371824|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371725|NCT00701805|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371726|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371727|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371728|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371729|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371730|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371731|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371732|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371733|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371734|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371735|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371736|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371737|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371738|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
372001|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
371739|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371740|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371741|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371742|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371743|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371744|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371745|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371746|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371747|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371748|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371749|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371750|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371751|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371752|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
372474|NCT00700739|E2|Reported Event|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
371753|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371754|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371755|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371756|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371757|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371758|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371759|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371760|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371761|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371762|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371763|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371764|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371765|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371766|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
372475|NCT00700739|E1|Reported Event|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
371767|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371768|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371769|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371770|NCT00701805|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371771|NCT00701805|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371772|NCT00701805|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371773|NCT00701805|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
371774|NCT00701779|B1|Baseline|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371775|NCT00701779|P1|Participant Flow|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371776|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371777|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371778|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
372476|NCT00700713|B4|Baseline|Total|Total of all reporting groups
371779|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371780|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371781|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371782|NCT00701779|E1|Reported Event|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
371783|NCT00701727|B1|Baseline|Entire Study Population|Includes groups randomized to receive ezetimibe first and placebo first
371784|NCT00701727|P2|Participant Flow|Placebo First, Ezetimibe Second|Placebo first for 7 weeks,followed by ezetimibe for 7 weeks
371785|NCT00701727|P1|Participant Flow|Ezetimibe First, Placebo Second|Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
371786|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371787|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371788|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371789|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371790|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371791|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371792|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371793|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371794|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371795|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371796|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371797|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371798|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
371799|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
371800|NCT00701727|E2|Reported Event|Ezetimibe|ezetimibe, 10 mg/day, for 7 weeks
371801|NCT00701727|E1|Reported Event|Placebo|Placebo, 10 mg/day, for 7 weeks
371802|NCT00701675|B4|Baseline|Total|Total of all reporting groups
371803|NCT00701675|B3|Baseline|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
371804|NCT00701675|B2|Baseline|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
371805|NCT00701675|B1|Baseline|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
371806|NCT00701675|P3|Participant Flow|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
371807|NCT00701675|P2|Participant Flow|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
371808|NCT00701675|P1|Participant Flow|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
371809|NCT00701675|O3|Outcome|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
371810|NCT00701675|O2|Outcome|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
371811|NCT00701675|O1|Outcome|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
371812|NCT00701675|E3|Reported Event|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
371813|NCT00701675|E2|Reported Event|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
371814|NCT00701675|E1|Reported Event|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
371815|NCT00701662|B1|Baseline|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371816|NCT00701662|P1|Participant Flow|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371817|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371818|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371819|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371820|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371821|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371822|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371826|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371827|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371828|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371829|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371830|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371831|NCT00701662|E1|Reported Event|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
371832|NCT00701636|B3|Baseline|Total|Total of all reporting groups
371833|NCT00701636|B2|Baseline|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
371834|NCT00701636|B1|Baseline|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
371835|NCT00701636|P2|Participant Flow|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
371836|NCT00701636|P1|Participant Flow|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
371837|NCT00701636|O1|Outcome|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
371838|NCT00701636|E2|Reported Event|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
371839|NCT00701636|E1|Reported Event|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
371840|NCT00701558|B1|Baseline|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371841|NCT00701558|P1|Participant Flow|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371842|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371843|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371844|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371845|NCT00701558|E1|Reported Event|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
371846|NCT00701441|B3|Baseline|Total|Total of all reporting groups
371847|NCT00701441|B2|Baseline|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
371848|NCT00701441|B1|Baseline|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
371849|NCT00701441|P2|Participant Flow|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
371850|NCT00701441|P1|Participant Flow|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
371851|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(Stain Density Units)
371852|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure(Stain Density Units)
371853|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment(Stain Density Units)
371854|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
371855|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure
371856|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment
378156|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
371857|NCT00701441|E2|Reported Event|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
371858|NCT00701441|E1|Reported Event|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
371859|NCT00701415|B3|Baseline|Total|Total of all reporting groups
371860|NCT00701415|B2|Baseline|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371861|NCT00701415|B1|Baseline|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371862|NCT00701415|P2|Participant Flow|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371863|NCT00701415|P1|Participant Flow|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371864|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371865|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371866|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371867|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371868|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371869|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371870|NCT00701415|E2|Reported Event|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371871|NCT00701415|E1|Reported Event|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
371872|NCT00701389|B1|Baseline|All Enrolled Participants|All participants enrolled in the study
371873|NCT00701389|P4|Participant Flow|Sequence 4: D→A→B→C|Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
371874|NCT00701389|P3|Participant Flow|Sequence 3: C→B→A→D|Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.
371875|NCT00701389|P2|Participant Flow|Sequence 2: B→D→C→A|Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.
371876|NCT00701389|P1|Participant Flow|Sequence 1: A→C→D→B|Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.
371877|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
371878|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
371879|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
371880|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371881|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
371882|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
372477|NCT00700713|B3|Baseline|Menactra-naïve Group|Participants had never received Menactra® vaccine.
371883|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
371884|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371885|NCT00701389|O2|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
371886|NCT00701389|O1|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371887|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
371888|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371889|NCT00701389|E4|Reported Event|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
371890|NCT00701389|E3|Reported Event|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371891|NCT00701389|E2|Reported Event|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
371892|NCT00701389|E1|Reported Event|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
371893|NCT00701363|B5|Baseline|Total|Total of all reporting groups
371894|NCT00701363|B4|Baseline|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
371895|NCT00701363|B3|Baseline|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
371896|NCT00701363|B2|Baseline|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
371897|NCT00701363|B1|Baseline|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
371898|NCT00701363|P4|Participant Flow|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
371899|NCT00701363|P3|Participant Flow|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
371900|NCT00701363|P2|Participant Flow|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
371901|NCT00701363|P1|Participant Flow|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
371902|NCT00701363|O1|Outcome|Overall Study|
371903|NCT00701363|O1|Outcome|Overall Study|Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24
371904|NCT00701363|O5|Outcome|Overall Study|
371905|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
371906|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
371907|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
371908|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
371909|NCT00701363|O1|Outcome|Overall Study|
371910|NCT00701363|O1|Outcome|Overall Study|
371911|NCT00701363|O5|Outcome|Overall Study|
371912|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
371913|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
371914|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
371915|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
371916|NCT00701363|O5|Outcome|Overall Study|
371917|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
371918|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
371919|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
371920|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
371921|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
371922|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
372754|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
371923|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
371924|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
371925|NCT00701363|O1|Outcome|Overall Study|
371926|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
371927|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
371928|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
371929|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
371930|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
371931|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
371932|NCT00701363|O1|Outcome|Overall Study|
371933|NCT00701363|O1|Outcome|Overall Study|
371934|NCT00701363|O1|Outcome|Overall Study|
371935|NCT00701363|O1|Outcome|Overall Study|
371936|NCT00701363|E4|Reported Event|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
371937|NCT00701363|E3|Reported Event|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
371938|NCT00701363|E2|Reported Event|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
371939|NCT00701363|E1|Reported Event|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
371940|NCT00701311|B1|Baseline|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
371941|NCT00701311|P1|Participant Flow|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
371942|NCT00701311|O1|Outcome|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
371943|NCT00701311|E1|Reported Event|Treatment Arm|Open label, one arm study.
371944|NCT00701129|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371945|NCT00701129|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371946|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371947|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371961|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
378157|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
371948|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371949|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371950|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371951|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371952|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371953|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371954|NCT00701129|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
371955|NCT00701090|B3|Baseline|Total|Total of all reporting groups
371956|NCT00701090|B2|Baseline|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371957|NCT00701090|B1|Baseline|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371958|NCT00701090|P2|Participant Flow|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371959|NCT00701090|P1|Participant Flow|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371960|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371962|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371963|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371964|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371965|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371966|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371967|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371968|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371969|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371970|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371971|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371972|NCT00701090|E2|Reported Event|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371973|NCT00701090|E1|Reported Event|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
371974|NCT00701064|B3|Baseline|Total|Total of all reporting groups
371975|NCT00701064|B2|Baseline|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
371976|NCT00701064|B1|Baseline|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
371977|NCT00701064|P2|Participant Flow|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
371978|NCT00701064|P1|Participant Flow|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
371979|NCT00701064|O2|Outcome|Arm 2: Placebo Negative Ion Generator|"Negative Ion Generator (30 min/day)~Inactivated Negative Ion Generator: Administered via Negative Ion Generator"
371980|NCT00701064|O1|Outcome|Arm 1: Bright Light|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
371981|NCT00701064|E2|Reported Event|Arm 2: Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
371982|NCT00701064|E1|Reported Event|Arm 1: Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
371983|NCT00701051|B3|Baseline|Total|Total of all reporting groups
371984|NCT00701051|B2|Baseline|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
371985|NCT00701051|B1|Baseline|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
371986|NCT00701051|P3|Participant Flow|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
371987|NCT00701051|P2|Participant Flow|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening
371988|NCT00701051|P1|Participant Flow|Older Adults|
371989|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
371990|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
371991|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
371992|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
371993|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
371994|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
371995|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
371996|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
371997|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
371998|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
371999|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
372000|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
378158|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
372002|NCT00701051|E1|Reported Event|Older Adults|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
372003|NCT00701038|B3|Baseline|Total|Total of all reporting groups
372004|NCT00701038|B2|Baseline|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
372005|NCT00701038|B1|Baseline|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
372006|NCT00701038|P2|Participant Flow|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
372007|NCT00701038|P1|Participant Flow|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
372008|NCT00701038|O2|Outcome|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
372009|NCT00701038|O1|Outcome|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
372010|NCT00701038|E2|Reported Event|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
372011|NCT00701038|E1|Reported Event|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
372012|NCT00700999|B3|Baseline|Total|Total of all reporting groups
372013|NCT00700999|B2|Baseline|Combat Exposed Controls|veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
372014|NCT00700999|B1|Baseline|Treatment Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
372015|NCT00700999|P2|Participant Flow|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
372016|NCT00700999|P1|Participant Flow|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD)
372017|NCT00700999|O2|Outcome|Combat Exposed Control|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
372018|NCT00700999|O1|Outcome|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
372019|NCT00700999|E2|Reported Event|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
372020|NCT00700999|E1|Reported Event|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
372021|NCT00700973|B3|Baseline|Total|Total of all reporting groups
372022|NCT00700973|B2|Baseline|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
372023|NCT00700973|B1|Baseline|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
372024|NCT00700973|P2|Participant Flow|IPV-P|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
372025|NCT00700973|P1|Participant Flow|Usual Care|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
372026|NCT00700973|O2|Outcome|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
372027|NCT00700973|O1|Outcome|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
372028|NCT00700973|E2|Reported Event|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
372029|NCT00700973|E1|Reported Event|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
372030|NCT00700817|B6|Baseline|Total|Total of all reporting groups
372031|NCT00700817|B5|Baseline|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372032|NCT00700817|B4|Baseline|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372033|NCT00700817|B3|Baseline|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372034|NCT00700817|B2|Baseline|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372035|NCT00700817|B1|Baseline|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372036|NCT00700817|P5|Participant Flow|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372037|NCT00700817|P4|Participant Flow|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372038|NCT00700817|P3|Participant Flow|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372039|NCT00700817|P2|Participant Flow|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372040|NCT00700817|P1|Participant Flow|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372041|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372042|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372043|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372044|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372045|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372046|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372047|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372048|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372049|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372050|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372051|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372052|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372053|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372054|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372055|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372056|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372057|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372058|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372478|NCT00700713|B2|Baseline|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26
372059|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372060|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372061|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372062|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372063|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372064|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372065|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372066|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372067|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372068|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372069|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372070|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372071|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372072|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372073|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372074|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372075|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372076|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372077|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372078|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372079|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378159|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
372080|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372081|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372082|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372083|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372084|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372085|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372086|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372087|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372088|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372089|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372090|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372091|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372092|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372093|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372094|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372095|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372096|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372097|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372098|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372099|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372100|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378160|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
372101|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372102|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372103|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372104|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372105|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372106|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372107|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372108|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372109|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372110|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372111|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372112|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372113|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372114|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372115|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372116|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372117|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372118|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372119|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372120|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372121|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372755|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372122|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372123|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372124|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372125|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372126|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372127|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372128|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372129|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372130|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372131|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372132|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372133|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372134|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372135|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372136|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372137|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372138|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372139|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372140|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372141|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372142|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372756|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372143|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372144|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372145|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372146|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372147|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372148|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372149|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372150|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372151|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372152|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372153|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372154|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372155|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372156|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372157|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372158|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372159|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372160|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372161|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372162|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372163|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372479|NCT00700713|B1|Baseline|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
378161|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
372164|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372165|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372166|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372167|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372168|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372169|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372170|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372171|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372172|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372173|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372174|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372175|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372176|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372177|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372178|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372179|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372180|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372181|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372182|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372183|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372184|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378162|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
372185|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372186|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372187|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372188|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372189|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372190|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372191|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372192|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372193|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372194|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372195|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372196|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372197|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372198|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372199|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372200|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372201|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372202|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372203|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372204|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372205|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378163|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
372206|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372207|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372208|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372209|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372210|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372211|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372212|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372213|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372214|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372215|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372216|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372217|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372218|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372219|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372220|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372221|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372222|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372223|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372224|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372225|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372226|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372757|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372227|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372228|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372229|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372230|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372231|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372232|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372233|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372234|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372235|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372236|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372237|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372238|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372239|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372240|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372241|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372242|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372243|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372244|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372245|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372246|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372247|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372758|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372248|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372249|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372250|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372251|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372252|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372253|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372254|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372255|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372256|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372257|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372258|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372259|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372260|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372261|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372262|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372263|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372264|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372265|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372266|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372267|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372268|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372480|NCT00700713|P3|Participant Flow|Menactra-naïve Group|Participants had never received Menactra® vaccine.
378164|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
372269|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372270|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372271|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372272|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372273|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372274|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372275|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372276|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372277|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372278|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372279|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372280|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372281|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372282|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372283|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372284|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372285|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372286|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372287|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372288|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372289|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378165|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
372290|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372291|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372292|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372293|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372294|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372295|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372296|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372297|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372298|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372299|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372300|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372301|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372302|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372303|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372304|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372305|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372306|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372307|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372308|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372309|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372310|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378166|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
372311|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372312|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372313|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372314|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372315|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372316|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372317|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372318|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372319|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372320|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372321|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372322|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372323|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372324|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372325|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372326|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372327|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372328|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372329|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372330|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372331|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372759|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372332|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372333|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372334|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372335|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372336|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372337|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372338|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372339|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372340|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372341|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372342|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372343|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372344|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372345|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372346|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372347|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372348|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372349|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372350|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372351|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372352|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372760|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372353|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372354|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372355|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372356|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372357|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372358|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372359|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372360|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372361|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372362|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372363|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372364|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372365|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372366|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372367|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372368|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372369|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372370|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372371|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372372|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372373|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372481|NCT00700713|P2|Participant Flow|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
372761|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372374|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372375|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372376|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372377|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372378|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372379|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372380|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372381|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372382|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372383|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372384|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372385|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372386|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372387|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372388|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372389|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372390|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372391|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372392|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372393|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372394|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378167|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
372395|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372396|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372397|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372398|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372399|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372400|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372401|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372402|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372403|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372404|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372405|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372406|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372407|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372408|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372409|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372410|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372411|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
372412|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
372413|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372414|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372415|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
378168|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
372416|NCT00700817|E3|Reported Event|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
372417|NCT00700817|E2|Reported Event|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372418|NCT00700817|E1|Reported Event|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
372419|NCT00700804|B3|Baseline|Total|Total of all reporting groups
372420|NCT00700804|B2|Baseline|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
372421|NCT00700804|B1|Baseline|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
372422|NCT00700804|P2|Participant Flow|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
372423|NCT00700804|P1|Participant Flow|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
372424|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
372425|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
372426|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
372427|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
372428|NCT00700804|E2|Reported Event|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
372429|NCT00700804|E1|Reported Event|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
372430|NCT00700752|B1|Baseline|Overall|Completed study population
372431|NCT00700752|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
372432|NCT00700752|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
372433|NCT00700752|O2|Outcome|Balafilcon A|silicone hydrogel contact lens worn daily with a 4-week replacement regimen
372434|NCT00700752|O1|Outcome|Senofilcon A|silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
372435|NCT00700752|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
372436|NCT00700752|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
372437|NCT00700739|B3|Baseline|Total|Total of all reporting groups
372438|NCT00700739|B2|Baseline|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372439|NCT00700739|B1|Baseline|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372440|NCT00700739|P2|Participant Flow|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372441|NCT00700739|P1|Participant Flow|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
372442|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372443|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372444|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372445|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372446|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372447|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372448|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372449|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372450|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372451|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372452|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372453|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372454|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372455|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372456|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372457|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372458|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372459|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372460|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372461|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372462|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372463|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
372464|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372465|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
372466|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372467|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
372468|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372469|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
372470|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372471|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372472|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
372473|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
372482|NCT00700713|P1|Participant Flow|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
372483|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
372484|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
372485|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
372486|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
372487|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
372488|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
372489|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
372490|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
372491|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
372492|NCT00700713|E3|Reported Event|Menactra-naïve Group|Participants had never received Menactra® vaccine.
372493|NCT00700713|E2|Reported Event|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
372494|NCT00700713|E1|Reported Event|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
372495|NCT00700635|B4|Baseline|Total|Total of all reporting groups
372496|NCT00700635|B3|Baseline|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372497|NCT00700635|B2|Baseline|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372498|NCT00700635|B1|Baseline|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372499|NCT00700635|P3|Participant Flow|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372500|NCT00700635|P2|Participant Flow|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372501|NCT00700635|P1|Participant Flow|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372502|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372503|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372504|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372505|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372506|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372507|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372508|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372509|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372510|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372511|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372512|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372513|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372514|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372515|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372516|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372517|NCT00700635|E3|Reported Event|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
372518|NCT00700635|E2|Reported Event|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
372519|NCT00700635|E1|Reported Event|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
372520|NCT00700622|B3|Baseline|Total|Total of all reporting groups
372521|NCT00700622|B2|Baseline|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
372522|NCT00700622|B1|Baseline|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
372523|NCT00700622|P2|Participant Flow|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
372524|NCT00700622|P1|Participant Flow|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
372525|NCT00700622|O2|Outcome|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
372526|NCT00700622|O1|Outcome|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
372527|NCT00700622|E2|Reported Event|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
372528|NCT00700622|E1|Reported Event|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
372529|NCT00700570|B3|Baseline|Total|Total of all reporting groups
372530|NCT00700570|B2|Baseline|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372561|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372531|NCT00700570|B1|Baseline|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372532|NCT00700570|P2|Participant Flow|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, repeated neoadjuvant treatment until documented resectability or progressive disease (PD). Participants could be withdrawn at any point for unacceptable toxicity.
372533|NCT00700570|P1|Participant Flow|Resected|Participants with unresectable liver metastases secondary to colorectal cancer (CRC) were assigned to receive neoadjuvant treatment of intravenous (IV) bevacizumab with oral (PO) capecitabine and IV oxaliplatin (XELOX). Bevacizumab was given as 5 milligrams per kilogram (mg/kg) on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 milligrams per meter-squared (mg/m^2) on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372534|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372535|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372536|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372537|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372538|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372539|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372562|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372762|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372540|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372541|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
372542|NCT00700570|O1|Outcome|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372543|NCT00700570|E1|Reported Event|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
372544|NCT00700440|B1|Baseline|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
372545|NCT00700440|P1|Participant Flow|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
372546|NCT00700440|O1|Outcome|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
372547|NCT00700440|E1|Reported Event|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
372548|NCT00700427|B1|Baseline|Atomoxetine (40-100 mg)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
372549|NCT00700427|P5|Participant Flow|Atomoxetine (Study Period 4)|Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
372550|NCT00700427|P4|Participant Flow|Placebo (Study Period 3B)|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372551|NCT00700427|P3|Participant Flow|Atomoxetine (Study Period 3B)|80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372552|NCT00700427|P2|Participant Flow|Atomoxetine (Study Period 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).
372553|NCT00700427|P1|Participant Flow|Atomoxetine (Study Period 2)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
372554|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372555|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372556|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372557|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372558|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372559|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372560|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372598|NCT00700310|B1|Baseline|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372563|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372564|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372565|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372566|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372567|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372568|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372569|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
372570|NCT00700427|E4|Reported Event|Atomoxetine (Study Period 4; Open-Label Extension)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
372571|NCT00700427|E3|Reported Event|Placebo (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
372572|NCT00700427|E2|Reported Event|Atomoxetine (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
372573|NCT00700427|E1|Reported Event|Atomoxetine (Study Periods 2 and 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
372574|NCT00700401|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372575|NCT00700401|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372576|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372577|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372578|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372579|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372580|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372581|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372582|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372583|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372584|NCT00700401|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
372585|NCT00700375|B3|Baseline|Total|Total of all reporting groups
372599|NCT00700310|P4|Participant Flow|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372586|NCT00700375|B2|Baseline|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372587|NCT00700375|B1|Baseline|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372588|NCT00700375|P2|Participant Flow|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372589|NCT00700375|P1|Participant Flow|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372590|NCT00700375|O2|Outcome|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372591|NCT00700375|O1|Outcome|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372592|NCT00700375|E2|Reported Event|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372593|NCT00700375|E1|Reported Event|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
372594|NCT00700310|B5|Baseline|Total|Total of all reporting groups
372595|NCT00700310|B4|Baseline|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372596|NCT00700310|B3|Baseline|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372597|NCT00700310|B2|Baseline|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372763|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372600|NCT00700310|P3|Participant Flow|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372601|NCT00700310|P2|Participant Flow|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372602|NCT00700310|P1|Participant Flow|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372603|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372604|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372605|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372606|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372607|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372608|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372609|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372610|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372611|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372612|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372613|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372614|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372615|NCT00700310|E4|Reported Event|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
372616|NCT00700310|E3|Reported Event|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
372617|NCT00700310|E2|Reported Event|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372618|NCT00700310|E1|Reported Event|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
372619|NCT00700271|B3|Baseline|Total|Total of all reporting groups
372620|NCT00700271|B2|Baseline|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372621|NCT00700271|B1|Baseline|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372622|NCT00700271|P2|Participant Flow|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372623|NCT00700271|P1|Participant Flow|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372624|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372676|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
372677|NCT00700141|E1|Reported Event|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
372678|NCT00700115|B3|Baseline|Total|Total of all reporting groups
372679|NCT00700115|B2|Baseline|Standard HAART|Pre-study standard HAART regimen
372680|NCT00700115|B1|Baseline|Kaletra + Isentress|switched to Kaletra + Isentress
372625|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372626|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372627|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372628|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372629|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372630|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372631|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372632|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372633|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372634|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372681|NCT00700115|P2|Participant Flow|Standard HAART|Pre-study standard HAART regimen
372682|NCT00700115|P1|Participant Flow|Kaletra + Isentress|Switched to Kaletra + Isentress
372683|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
372635|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372636|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372637|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372638|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372639|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372640|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372641|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372642|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372643|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372644|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372684|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
372685|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
372686|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
372645|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372646|NCT00700271|E2|Reported Event|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372647|NCT00700271|E1|Reported Event|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
372648|NCT00700180|B3|Baseline|Total|Total of all reporting groups
372649|NCT00700180|B2|Baseline|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372650|NCT00700180|B1|Baseline|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372651|NCT00700180|P2|Participant Flow|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372652|NCT00700180|P1|Participant Flow|Bevacizumab 7.5 Milligrams (mg) Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg per kilogram (mg/kg) intravenously (IV) on Day 1; either carboplatin at a dose required to achieve an area under the concentration-time curve (AUC) of 6 mg per milliliter (mg/mL) IV and paclitaxel 200 mg per square meter (mg/m^2) IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372653|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372654|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372687|NCT00700115|E2|Reported Event|Standard HAART|Pre-study standard HAART regimen
372688|NCT00700115|E1|Reported Event|Kaletra + Isentress|switched to Kaletra + Isentress
372689|NCT00700102|B3|Baseline|Total|Total of all reporting groups
372764|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372765|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372655|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372656|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372657|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372658|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372659|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372660|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372661|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372662|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372663|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372690|NCT00700102|B2|Baseline|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
372691|NCT00700102|B1|Baseline|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
372766|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372664|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372665|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372666|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372667|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372668|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372669|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372670|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372671|NCT00700180|E2|Reported Event|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372672|NCT00700180|E1|Reported Event|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
372673|NCT00700141|B1|Baseline|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
372674|NCT00700141|P1|Participant Flow|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
372675|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
372752|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372692|NCT00700102|P2|Participant Flow|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
372693|NCT00700102|P1|Participant Flow|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
372694|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372695|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372696|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372697|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372698|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372699|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372700|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372701|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372702|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372703|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372704|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372705|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372706|NCT00700102|E2|Reported Event|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
372707|NCT00700102|E1|Reported Event|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
372708|NCT00700063|B9|Baseline|Total|Total of all reporting groups
372709|NCT00700063|B8|Baseline|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372710|NCT00700063|B7|Baseline|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372711|NCT00700063|B6|Baseline|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372712|NCT00700063|B5|Baseline|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372713|NCT00700063|B4|Baseline|4. Vehicle Gel|Two days treatment, day 1, 2
372714|NCT00700063|B3|Baseline|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372715|NCT00700063|B2|Baseline|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372716|NCT00700063|B1|Baseline|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372717|NCT00700063|P8|Participant Flow|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372718|NCT00700063|P7|Participant Flow|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372719|NCT00700063|P6|Participant Flow|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372720|NCT00700063|P5|Participant Flow|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372721|NCT00700063|P4|Participant Flow|4. Vehicle Gel|Two days treatment, day 1, 2
372722|NCT00700063|P3|Participant Flow|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372723|NCT00700063|P2|Participant Flow|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372724|NCT00700063|P1|Participant Flow|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372725|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372726|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372727|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372728|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372729|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372730|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372731|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372732|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372733|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372734|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372735|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372736|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372737|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372738|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372739|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372740|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372741|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372742|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372743|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372744|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372745|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372746|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372747|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372748|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372749|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372750|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372751|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372767|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372768|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372769|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372770|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372771|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372772|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372773|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372774|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372775|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372776|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372777|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372778|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372779|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372780|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372781|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372782|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372783|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372784|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372785|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372786|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372787|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372788|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372789|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372790|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372791|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372792|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372793|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372794|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372795|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372796|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372797|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372798|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372799|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372800|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372801|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372802|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372803|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372804|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372805|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372806|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372807|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372808|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372809|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372810|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372811|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372812|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372813|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372814|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372815|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372816|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372817|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
372818|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372819|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372820|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372821|NCT00700063|E8|Reported Event|8. Vehicle Gel|Three days treatment, day 1, 2, 3
372822|NCT00700063|E7|Reported Event|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
372823|NCT00700063|E6|Reported Event|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
372824|NCT00700063|E5|Reported Event|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
372825|NCT00700063|E4|Reported Event|4. Vehicle Gel|Two days treatment, day 1, 2
372826|NCT00700063|E3|Reported Event|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
372827|NCT00700063|E2|Reported Event|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
372828|NCT00700063|E1|Reported Event|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
372829|NCT00700011|B3|Baseline|Total|Total of all reporting groups
372830|NCT00700011|B2|Baseline|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372908|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372909|NCT00699972|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372831|NCT00700011|B1|Baseline|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372832|NCT00700011|P2|Participant Flow|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372833|NCT00700011|P1|Participant Flow|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372834|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372835|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372836|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372837|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372838|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372839|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372840|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372841|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372842|NCT00700011|E2|Reported Event|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372843|NCT00700011|E1|Reported Event|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
372844|NCT00699998|B5|Baseline|Total|Total of all reporting groups
372845|NCT00699998|B4|Baseline|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372846|NCT00699998|B3|Baseline|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372847|NCT00699998|B2|Baseline|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372848|NCT00699998|B1|Baseline|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372849|NCT00699998|P4|Participant Flow|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
372850|NCT00699998|P3|Participant Flow|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
372851|NCT00699998|P2|Participant Flow|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study."
372852|NCT00699998|P1|Participant Flow|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
372853|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
372854|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
372855|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study."
372856|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
372857|NCT00699998|O2|Outcome|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372858|NCT00699998|O1|Outcome|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
372859|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372860|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372861|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372862|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372863|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372864|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372865|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
373041|NCT00699699|E1|Reported Event|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
372866|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372867|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372868|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372869|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372870|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372871|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372872|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372873|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372874|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372875|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372876|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372877|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372878|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372879|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372880|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372881|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
373042|NCT00699660|B3|Baseline|Total|Total of all reporting groups
372882|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372883|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372884|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372885|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372886|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372887|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372888|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372889|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
372890|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
372891|NCT00699998|E2|Reported Event|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
372892|NCT00699998|E1|Reported Event|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
372893|NCT00699972|B4|Baseline|Total|Total of all reporting groups
372894|NCT00699972|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372895|NCT00699972|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372896|NCT00699972|B1|Baseline|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372897|NCT00699972|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372898|NCT00699972|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372899|NCT00699972|P1|Participant Flow|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372900|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372901|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372902|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372903|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372904|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372905|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372906|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
372907|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372910|NCT00699972|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
372911|NCT00699972|E1|Reported Event|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
372912|NCT00699842|B4|Baseline|Total|Total of all reporting groups
372913|NCT00699842|B3|Baseline|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372914|NCT00699842|B2|Baseline|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372915|NCT00699842|B1|Baseline|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372916|NCT00699842|P3|Participant Flow|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372917|NCT00699842|P2|Participant Flow|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372918|NCT00699842|P1|Participant Flow|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372919|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372920|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372921|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372922|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372923|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372924|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372925|NCT00699842|E3|Reported Event|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372926|NCT00699842|E2|Reported Event|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372927|NCT00699842|E1|Reported Event|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
372928|NCT00699816|B3|Baseline|Total|Total of all reporting groups
372929|NCT00699816|B2|Baseline|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372930|NCT00699816|B1|Baseline|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372931|NCT00699816|P2|Participant Flow|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372932|NCT00699816|P1|Participant Flow|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372955|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372956|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372933|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372934|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372935|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372936|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372937|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372938|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372939|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372940|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372941|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372942|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372943|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372944|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372945|NCT00699816|E2|Reported Event|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
372946|NCT00699816|E1|Reported Event|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
372947|NCT00699751|B3|Baseline|Total|Total of all reporting groups
372948|NCT00699751|B2|Baseline|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372949|NCT00699751|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372950|NCT00699751|P2|Participant Flow|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
372951|NCT00699751|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
372952|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372953|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372954|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372998|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372957|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372958|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372959|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372960|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372961|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372962|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372963|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372964|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372965|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372966|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372967|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372968|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372969|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372970|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372971|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372972|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372973|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372974|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372975|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372976|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372977|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372978|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372979|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372980|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372981|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372982|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372983|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372984|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372985|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372986|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372987|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372988|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372989|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372990|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372991|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372992|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372993|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372994|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372995|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372996|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
372997|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
372999|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373000|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373001|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373002|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373003|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373004|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373005|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373006|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373007|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373008|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373009|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373010|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373011|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373012|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373013|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373014|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373015|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373016|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373017|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373018|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373019|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373020|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373021|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373022|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373023|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373024|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373025|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373026|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373027|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373028|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373029|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373030|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
373031|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
373032|NCT00699751|E3|Reported Event|Placebo Randomized, Then Switched to Radium-223 Dichloride|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
373033|NCT00699751|E2|Reported Event|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.
373034|NCT00699751|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
373035|NCT00699699|B1|Baseline|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373036|NCT00699699|P1|Participant Flow|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373037|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373038|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373039|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373040|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
373104|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373043|NCT00699660|B2|Baseline|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373044|NCT00699660|B1|Baseline|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373045|NCT00699660|P2|Participant Flow|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373046|NCT00699660|P1|Participant Flow|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373047|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373048|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373049|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373050|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373051|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373052|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373053|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373054|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373055|NCT00699660|E2|Reported Event|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
373056|NCT00699660|E1|Reported Event|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
373057|NCT00699608|B1|Baseline|Entire Study Population|
373058|NCT00699608|P6|Participant Flow|Placebo First, Zopiclone Second, Eszopiclone Third|Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
373059|NCT00699608|P5|Participant Flow|Placebo First, Eszopiclone Second, Zopiclone Third|Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
373060|NCT00699608|P4|Participant Flow|Zopiclone First, Placebo Second, Eszopiclone Third|7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
373061|NCT00699608|P3|Participant Flow|Zopiclone First, Eszopiclone Second, Placebo Third|7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
373062|NCT00699608|P2|Participant Flow|Eszopiclone First, Placebo Second, Zopiclone Third|3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
373063|NCT00699608|P1|Participant Flow|Eszopiclone First, Zopiclone Second, Placebo Third|3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
373064|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373065|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373066|NCT00699608|O1|Outcome|Placebo|Placebo
373067|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373068|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373069|NCT00699608|O1|Outcome|Placebo|Placebo
373070|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373071|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373072|NCT00699608|O1|Outcome|Placebo|Placebo
373073|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373074|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373075|NCT00699608|O1|Outcome|Placebo|Placebo
373076|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373077|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373078|NCT00699608|O1|Outcome|Placebo|Placebo
373079|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373080|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373081|NCT00699608|O1|Outcome|Placebo|Placebo
373082|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373083|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373084|NCT00699608|O1|Outcome|Placebo|Placebo
373085|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373086|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373087|NCT00699608|O1|Outcome|Placebo|Placebo
373088|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373089|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373090|NCT00699608|O1|Outcome|Placebo|Placebo
373091|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373092|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373093|NCT00699608|O1|Outcome|Placebo|Placebo
373094|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373095|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373096|NCT00699608|O1|Outcome|Placebo|Placebo
373097|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373098|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373099|NCT00699608|O1|Outcome|Placebo|Placebo
373100|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373101|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
373102|NCT00699608|O1|Outcome|Placebo|Placebo
373103|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
373113|NCT00699582|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373114|NCT00699582|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373115|NCT00699582|B1|Baseline|Placebo|
373116|NCT00699582|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373117|NCT00699582|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373118|NCT00699582|P1|Participant Flow|Placebo|
373119|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373120|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373121|NCT00699582|O1|Outcome|Placebo|
373122|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373123|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373124|NCT00699582|O1|Outcome|Placebo|
373125|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373126|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373127|NCT00699582|O1|Outcome|Placebo|
373128|NCT00699582|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
373129|NCT00699582|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
373130|NCT00699582|E1|Reported Event|Placebo|
373131|NCT00699491|B7|Baseline|Total|Total of all reporting groups
373132|NCT00699491|B6|Baseline|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373133|NCT00699491|B5|Baseline|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373134|NCT00699491|B4|Baseline|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373135|NCT00699491|B3|Baseline|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373136|NCT00699491|B2|Baseline|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373137|NCT00699491|B1|Baseline|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373138|NCT00699491|P6|Participant Flow|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373139|NCT00699491|P5|Participant Flow|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373140|NCT00699491|P4|Participant Flow|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373141|NCT00699491|P3|Participant Flow|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373142|NCT00699491|P2|Participant Flow|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373143|NCT00699491|P1|Participant Flow|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373144|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373145|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373146|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373267|NCT00699192|B1|Baseline|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373891|NCT00696761|B4|Baseline|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
373147|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373148|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373149|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373150|NCT00699491|O5|Outcome|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373151|NCT00699491|O4|Outcome|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373152|NCT00699491|O3|Outcome|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373153|NCT00699491|O2|Outcome|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373154|NCT00699491|O1|Outcome|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
373155|NCT00699491|E6|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
373156|NCT00699491|E5|Reported Event|Dose Level -2B|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
373157|NCT00699491|E4|Reported Event|Dose Level -2A|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
373158|NCT00699491|E3|Reported Event|Dose Level -2|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
373159|NCT00699491|E2|Reported Event|Dose Level -1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
373160|NCT00699491|E1|Reported Event|Dose Level 1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
373161|NCT00699400|B4|Baseline|Total|Total of all reporting groups
373162|NCT00699400|B3|Baseline|Pre-Freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
373163|NCT00699400|B2|Baseline|Vitrification|Subjects that participated in one or more vitrification cycles
373164|NCT00699400|B1|Baseline|Slow Freeze|Subjects that participated in one or more slow-freeze cycles
373165|NCT00699400|P6|Participant Flow|Pre-freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
373166|NCT00699400|P5|Participant Flow|Both (Slow Freeze and Vitrification)|Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
373167|NCT00699400|P4|Participant Flow|Vitrification (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
373168|NCT00699400|P3|Participant Flow|Vitrification (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
373169|NCT00699400|P2|Participant Flow|Slow Freeze (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
373170|NCT00699400|P1|Participant Flow|Slow Freeze (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
373171|NCT00699400|O3|Outcome|All Participants|
373172|NCT00699400|O2|Outcome|Vitrification|
373173|NCT00699400|O1|Outcome|Slow Freezing|
373174|NCT00699400|O3|Outcome|All Participants|
373175|NCT00699400|O2|Outcome|Vitrification|
373176|NCT00699400|O1|Outcome|Slow Freezing|
373177|NCT00699400|O3|Outcome|All Participants|
373178|NCT00699400|O2|Outcome|Vitrification|
373179|NCT00699400|O1|Outcome|Slow Freezing|
373180|NCT00699400|O3|Outcome|All Participants|
373181|NCT00699400|O2|Outcome|Vitrification|
373182|NCT00699400|O1|Outcome|Slow Freezing|
373183|NCT00699400|O3|Outcome|All Participants|
373184|NCT00699400|O2|Outcome|Vitrification|
373185|NCT00699400|O1|Outcome|Slow Freezing|
373186|NCT00699400|O3|Outcome|All Participants|
373187|NCT00699400|O2|Outcome|Vitrification|
373188|NCT00699400|O1|Outcome|Slow Freezing|
373189|NCT00699400|O3|Outcome|All Participants|
373190|NCT00699400|O2|Outcome|Vitrification|
373191|NCT00699400|O1|Outcome|Slow Freezing|
373192|NCT00699400|O3|Outcome|All Participants|
373193|NCT00699400|O2|Outcome|Vitrification|
373194|NCT00699400|O1|Outcome|Slow Freezing|
373195|NCT00699400|O3|Outcome|All Participants|
373196|NCT00699400|O2|Outcome|Vitrification|
373197|NCT00699400|O1|Outcome|Slow Freezing|
373198|NCT00699400|E3|Reported Event|All Participants|
373199|NCT00699400|E2|Reported Event|Vitrification|
373202|NCT00699374|B2|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373203|NCT00699374|B1|Baseline|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373204|NCT00699374|P2|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373205|NCT00699374|P1|Participant Flow|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373206|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373207|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373208|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373209|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373210|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373211|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373212|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373213|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373214|NCT00699374|E2|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373215|NCT00699374|E1|Reported Event|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
373216|NCT00699348|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373217|NCT00699348|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
373218|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373219|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373220|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373221|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373222|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373223|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373224|NCT00699348|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
373225|NCT00699335|B1|Baseline|Matrifen®|All patients enrolled
373226|NCT00699335|P1|Participant Flow|Matrifen®|All patients enrolled
373227|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
373228|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
373229|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
373230|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
373231|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373232|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373233|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373234|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373235|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
373236|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
373237|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373238|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373239|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373240|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373241|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373242|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373243|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373244|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373245|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373246|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373247|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373248|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373249|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373250|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373251|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
373252|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
373253|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
373254|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
373255|NCT00699335|E1|Reported Event|Matrifen®|Patients included and treated with at least one application of Matrifen®
373256|NCT00699283|B3|Baseline|Total Title|
373257|NCT00699283|B2|Baseline|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
373258|NCT00699283|B1|Baseline|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
373259|NCT00699283|P2|Participant Flow|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
373260|NCT00699283|P1|Participant Flow|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
373261|NCT00699283|O1|Outcome|Efficacy Set (Brivaracetam 50 mg Treated Subjects)|"50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).~The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs."
373262|NCT00699283|E2|Reported Event|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
373263|NCT00699283|E1|Reported Event|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
373264|NCT00699192|B4|Baseline|Total|Total of all reporting groups
373265|NCT00699192|B3|Baseline|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373266|NCT00699192|B2|Baseline|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373268|NCT00699192|P3|Participant Flow|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373269|NCT00699192|P2|Participant Flow|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373270|NCT00699192|P1|Participant Flow|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373271|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373272|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373273|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373274|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373275|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373276|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373277|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373278|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373279|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373280|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373281|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373282|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373283|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373284|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373285|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373286|NCT00699192|E3|Reported Event|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
373287|NCT00699192|E2|Reported Event|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
373288|NCT00699192|E1|Reported Event|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
373289|NCT00699153|B3|Baseline|Total|Total of all reporting groups
373290|NCT00699153|B2|Baseline|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373291|NCT00699153|B1|Baseline|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373292|NCT00699153|P2|Participant Flow|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373293|NCT00699153|P1|Participant Flow|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373294|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373295|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373296|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373297|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373298|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373299|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373300|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373301|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373302|NCT00699153|E2|Reported Event|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
373303|NCT00699153|E1|Reported Event|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
373304|NCT00699140|B1|Baseline|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373305|NCT00699140|P1|Participant Flow|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
373306|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
373307|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
373308|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373309|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.~The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint."
373310|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373311|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373484|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373312|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373313|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373314|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
373315|NCT00699140|E1|Reported Event|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
373316|NCT00698932|B3|Baseline|Total|Total of all reporting groups
373317|NCT00698932|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373318|NCT00698932|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373319|NCT00698932|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373320|NCT00698932|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373321|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373322|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373323|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373324|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373325|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373326|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373327|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373328|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373329|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373330|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373331|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373332|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373333|NCT00698932|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
373334|NCT00698932|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
373335|NCT00698841|B1|Baseline|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373336|NCT00698841|P1|Participant Flow|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373337|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373338|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373339|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373340|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373341|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373342|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373343|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373344|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373345|NCT00698841|E1|Reported Event|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
373346|NCT00698815|B4|Baseline|Total|Total of all reporting groups
373347|NCT00698815|B3|Baseline|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373348|NCT00698815|B2|Baseline|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373349|NCT00698815|B1|Baseline|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373350|NCT00698815|P3|Participant Flow|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373485|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373351|NCT00698815|P2|Participant Flow|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373352|NCT00698815|P1|Participant Flow|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373353|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373354|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373355|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373356|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373357|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373358|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373359|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373360|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373361|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373362|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373363|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373364|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373365|NCT00698815|E3|Reported Event|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
373366|NCT00698815|E2|Reported Event|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
373367|NCT00698815|E1|Reported Event|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
373368|NCT00698685|B1|Baseline|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
373369|NCT00698685|P1|Participant Flow|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
373396|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373370|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
373371|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
373372|NCT00698685|E1|Reported Event|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
373373|NCT00698646|B4|Baseline|Total|Total of all reporting groups
373374|NCT00698646|B3|Baseline|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373375|NCT00698646|B2|Baseline|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373376|NCT00698646|B1|Baseline|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373377|NCT00698646|P3|Participant Flow|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373378|NCT00698646|P2|Participant Flow|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373379|NCT00698646|P1|Participant Flow|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373380|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373381|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373382|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373383|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373384|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373385|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373386|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373387|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373388|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373389|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373390|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373391|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373392|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373393|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373394|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373395|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373397|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373398|NCT00698646|E3|Reported Event|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
373399|NCT00698646|E2|Reported Event|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
373400|NCT00698646|E1|Reported Event|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
373401|NCT00698581|B3|Baseline|Total Title|
373402|NCT00698581|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373403|NCT00698581|B1|Baseline|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373404|NCT00698581|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373405|NCT00698581|P1|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373406|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373407|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373408|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373409|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373410|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373411|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373412|NCT00698581|O1|Outcome|Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
373413|NCT00698581|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
373414|NCT00698581|E1|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
373415|NCT00698516|B1|Baseline|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
373416|NCT00698516|P1|Participant Flow|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
373417|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
373418|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
373419|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
378169|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
373420|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
373421|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
373422|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
373423|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensistive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
373424|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
373425|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
373426|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
373427|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
373428|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
373429|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
373430|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
373477|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373431|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
373432|NCT00698516|E1|Reported Event|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 mg/m^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK’s study physician was needed for subjects who required treatment beyond 8 cycles.
373433|NCT00698451|B1|Baseline|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
373434|NCT00698451|P1|Participant Flow|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
373435|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
373436|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
373437|NCT00698451|E1|Reported Event|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
373438|NCT00698204|B3|Baseline|Total|Total of all reporting groups
373439|NCT00698204|B2|Baseline|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
373440|NCT00698204|B1|Baseline|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
373441|NCT00698204|P2|Participant Flow|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
373442|NCT00698204|P1|Participant Flow|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
373443|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
373444|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
373445|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
373446|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
373447|NCT00698204|E2|Reported Event|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
373448|NCT00698204|E1|Reported Event|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
373449|NCT00698139|B4|Baseline|Total|Total of all reporting groups
373450|NCT00698139|B3|Baseline|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373451|NCT00698139|B2|Baseline|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373452|NCT00698139|B1|Baseline|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373478|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373479|NCT00698035|O1|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
378170|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
373453|NCT00698139|P3|Participant Flow|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373454|NCT00698139|P2|Participant Flow|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373455|NCT00698139|P1|Participant Flow|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373456|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373457|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373458|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373459|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373460|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373480|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373481|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373482|NCT00698035|O2|Outcome|E2 by RIA|Additional measurement of baseline and week 4 E2 by RIA
373483|NCT00698035|O1|Outcome|E2 by LC/MS|A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
373461|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373462|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373463|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373464|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373465|NCT00698139|E3|Reported Event|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
373466|NCT00698139|E2|Reported Event|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
373467|NCT00698139|E1|Reported Event|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
373468|NCT00698035|B3|Baseline|Total|Total of all reporting groups
373469|NCT00698035|B2|Baseline|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373470|NCT00698035|B1|Baseline|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373471|NCT00698035|P2|Participant Flow|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373472|NCT00698035|P1|Participant Flow|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373473|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373474|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373475|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373476|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373486|NCT00698035|E2|Reported Event|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
373487|NCT00698035|E1|Reported Event|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
373488|NCT00698022|B4|Baseline|Total|Total of all reporting groups
373489|NCT00698022|B3|Baseline|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
373490|NCT00698022|B2|Baseline|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
373491|NCT00698022|B1|Baseline|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
373492|NCT00698022|P3|Participant Flow|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
373493|NCT00698022|P2|Participant Flow|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
373494|NCT00698022|P1|Participant Flow|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
373495|NCT00698022|O3|Outcome|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
373496|NCT00698022|O2|Outcome|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
373497|NCT00698022|O1|Outcome|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
373498|NCT00698022|E3|Reported Event|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
373499|NCT00698022|E2|Reported Event|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
373500|NCT00698022|E1|Reported Event|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
373501|NCT00698009|B1|Baseline|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
373502|NCT00698009|P1|Participant Flow|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
373503|NCT00698009|O1|Outcome|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
373504|NCT00698009|E1|Reported Event|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
373505|NCT00697827|B3|Baseline|Total|Total of all reporting groups
373506|NCT00697827|B2|Baseline|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
373507|NCT00697827|B1|Baseline|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
373508|NCT00697827|P2|Participant Flow|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
373509|NCT00697827|P1|Participant Flow|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
373510|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
373547|NCT00697619|B2|Baseline|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373616|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373511|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
373512|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
373513|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
373514|NCT00697827|E2|Reported Event|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
373515|NCT00697827|E1|Reported Event|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
373516|NCT00697801|B4|Baseline|Total|Total of all reporting groups
373517|NCT00697801|B3|Baseline|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373518|NCT00697801|B2|Baseline|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373519|NCT00697801|B1|Baseline|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373520|NCT00697801|P3|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373521|NCT00697801|P2|Participant Flow|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373522|NCT00697801|P1|Participant Flow|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373523|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373524|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373525|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373526|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373527|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373528|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373529|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373530|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373531|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373532|NCT00697801|E3|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
373533|NCT00697801|E2|Reported Event|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
373534|NCT00697801|E1|Reported Event|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
373535|NCT00697697|B3|Baseline|Total|Total of all reporting groups
373536|NCT00697697|B2|Baseline|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373537|NCT00697697|B1|Baseline|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373538|NCT00697697|P2|Participant Flow|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373539|NCT00697697|P1|Participant Flow|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373540|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373541|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373542|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373543|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373544|NCT00697697|E2|Reported Event|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373545|NCT00697697|E1|Reported Event|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
373546|NCT00697619|B3|Baseline|Total|Total of all reporting groups
373548|NCT00697619|B1|Baseline|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373549|NCT00697619|P2|Participant Flow|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373550|NCT00697619|P1|Participant Flow|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373551|NCT00697619|O2|Outcome|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373552|NCT00697619|O1|Outcome|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373553|NCT00697619|E2|Reported Event|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373554|NCT00697619|E1|Reported Event|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
373555|NCT00697593|B1|Baseline|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373556|NCT00697593|P1|Participant Flow|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373557|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373558|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373559|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373560|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373561|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373562|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373563|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373564|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373565|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373566|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373567|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373568|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373569|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373570|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373571|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373572|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373573|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373574|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373575|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373576|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373614|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373577|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373578|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373579|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373580|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373581|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373582|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373583|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373584|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373585|NCT00697593|E1|Reported Event|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
373586|NCT00697541|B3|Baseline|Total|Total of all reporting groups
373587|NCT00697541|B2|Baseline|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
373588|NCT00697541|B1|Baseline|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
373589|NCT00697541|P2|Participant Flow|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
373590|NCT00697541|P1|Participant Flow|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
373591|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
373592|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
373593|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
373594|NCT00697541|O1|Outcome|Treatment A - COL-118 Gel + Saline Drops|COL-118 gel + saline drops
373595|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
373596|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
373597|NCT00697541|E2|Reported Event|Treatment B|Vehicle gel + brimonidine drops
373598|NCT00697541|E1|Reported Event|Treatment A|COL-118 gel + saline drops
373599|NCT00697515|B1|Baseline|Entire Study Population|
373600|NCT00697515|P2|Participant Flow|Placebo First|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
373601|NCT00697515|P1|Participant Flow|SPD489 First|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
373602|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373603|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373604|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373605|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373606|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373607|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373608|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373609|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373610|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373611|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373612|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373613|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373617|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373618|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373619|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373620|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373621|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373622|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373623|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373624|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
373625|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
373626|NCT00697515|E2|Reported Event|Placebo|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
373627|NCT00697515|E1|Reported Event|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
373628|NCT00697255|B3|Baseline|Total|Total of all reporting groups
373629|NCT00697255|B2|Baseline|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373630|NCT00697255|B1|Baseline|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373631|NCT00697255|P2|Participant Flow|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373632|NCT00697255|P1|Participant Flow|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373633|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373634|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373635|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373636|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373637|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
378171|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
373638|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373639|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373640|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373641|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373642|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373643|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373644|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373645|NCT00697255|E2|Reported Event|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373646|NCT00697255|E1|Reported Event|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
373647|NCT00697190|B1|Baseline|All Completed Subjects|All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
373648|NCT00697190|P2|Participant Flow|Galyfilcon A/Senofilcon A|galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
373649|NCT00697190|P1|Participant Flow|Senofilcon A/Galyfilcon A|senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
373650|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373651|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373652|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373653|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373654|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373655|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373656|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373657|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373658|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373659|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373660|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373661|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373662|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373663|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373664|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373665|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373666|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373667|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373668|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373669|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373670|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373671|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373672|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373673|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373674|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373675|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373676|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373677|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373678|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
373679|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
373680|NCT00697190|E2|Reported Event|Galyfilcon A|galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
373681|NCT00697190|E1|Reported Event|Senofilcon A|senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
373682|NCT00697112|B1|Baseline|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373683|NCT00697112|P1|Participant Flow|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373684|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373847|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
373848|NCT00696787|E3|Reported Event|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
373685|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373686|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373687|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373688|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373689|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373690|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373691|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373692|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373693|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373694|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373695|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373696|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373697|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
378172|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
373698|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373699|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373700|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373701|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373702|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373703|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373704|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373705|NCT00697112|E1|Reported Event|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
373706|NCT00697073|B1|Baseline|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
373707|NCT00697073|P1|Participant Flow|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
373708|NCT00697073|O1|Outcome|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
373709|NCT00697073|E1|Reported Event|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
373710|NCT00696878|B1|Baseline|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373711|NCT00696878|P1|Participant Flow|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
373849|NCT00696787|E2|Reported Event|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
373850|NCT00696787|E1|Reported Event|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
373851|NCT00696774|B4|Baseline|Total|Total of all reporting groups
373892|NCT00696761|B3|Baseline|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
373712|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373713|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373714|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373715|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373716|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373717|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373718|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373719|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373720|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373721|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373722|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373723|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373724|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373725|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373726|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373727|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373728|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373729|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373730|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373731|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373732|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373733|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373734|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373735|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373736|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373737|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373738|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373739|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373740|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373741|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373742|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373743|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373744|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373745|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373746|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373747|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373748|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373749|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373750|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373751|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373752|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373753|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373754|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373755|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373756|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373757|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373758|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373759|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373760|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373761|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373762|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373763|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373764|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373765|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373766|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373767|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373768|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373769|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373770|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373771|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373772|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373773|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373774|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373775|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373776|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373777|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373778|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373779|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373780|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373781|NCT00696878|E1|Reported Event|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
373782|NCT00696800|B3|Baseline|Total|Total of all reporting groups
373783|NCT00696800|B2|Baseline|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373784|NCT00696800|B1|Baseline|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373785|NCT00696800|P2|Participant Flow|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373786|NCT00696800|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
373787|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373788|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373789|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373852|NCT00696774|B3|Baseline|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
373853|NCT00696774|B2|Baseline|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373790|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373791|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373792|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373793|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373794|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373795|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373796|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373797|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373798|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373799|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373800|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373801|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373854|NCT00696774|B1|Baseline|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373893|NCT00696761|B2|Baseline|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
373802|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373803|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373804|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373805|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373806|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373807|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373808|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373809|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373810|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373811|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373812|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373813|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373855|NCT00696774|P3|Participant Flow|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
373894|NCT00696761|B1|Baseline|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
373814|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373815|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373816|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373817|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373818|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373819|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373820|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373821|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373822|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373823|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373824|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373825|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373856|NCT00696774|P2|Participant Flow|Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373895|NCT00696761|P4|Participant Flow|BOOI<20, BCI< 100|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
373826|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373827|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373828|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373829|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373830|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373831|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373832|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373833|NCT00696800|E2|Reported Event|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373834|NCT00696800|E1|Reported Event|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
373835|NCT00696787|B4|Baseline|Total|Total of all reporting groups
373836|NCT00696787|B3|Baseline|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
373837|NCT00696787|B2|Baseline|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
373838|NCT00696787|B1|Baseline|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
373839|NCT00696787|P3|Participant Flow|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
373840|NCT00696787|P2|Participant Flow|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
373841|NCT00696787|P1|Participant Flow|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
373842|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
373843|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
373844|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
373845|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
373846|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
378173|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
373857|NCT00696774|P1|Participant Flow|Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373858|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373859|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373860|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373861|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373862|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373863|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373864|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373865|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373866|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373867|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373868|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373869|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373870|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373871|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373872|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373873|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373874|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373875|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373876|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373877|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373878|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373879|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373880|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373881|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373882|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373883|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373884|NCT00696774|O1|Outcome|Duloxetine|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
373885|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373886|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373887|NCT00696774|E3|Reported Event|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
373888|NCT00696774|E2|Reported Event|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
373889|NCT00696774|E1|Reported Event|Duloxetine Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
373890|NCT00696761|B5|Baseline|Total|Total of all reporting groups
373896|NCT00696761|P3|Participant Flow|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
373897|NCT00696761|P2|Participant Flow|BOOI≥20, BCI< 100|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
373898|NCT00696761|P1|Participant Flow|BOOI≥20, BCI≥ 100|"Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100~alfuzosin : 10mg, once daily, 12months"
373899|NCT00696761|O4|Outcome|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
373900|NCT00696761|O3|Outcome|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
373901|NCT00696761|O2|Outcome|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
373902|NCT00696761|O1|Outcome|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
373903|NCT00696761|O4|Outcome|BOOI<20, BCI<100|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12 months"
373904|NCT00696761|O3|Outcome|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
373905|NCT00696761|O2|Outcome|BOOI≥ 20, BCI<100|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
373906|NCT00696761|O1|Outcome|BOOI≥ 20, BCI≥100|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
373907|NCT00696761|E4|Reported Event|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
373908|NCT00696761|E3|Reported Event|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
373909|NCT00696761|E2|Reported Event|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
373910|NCT00696761|E1|Reported Event|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
373911|NCT00696696|B1|Baseline|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373912|NCT00696696|P1|Participant Flow|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373913|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373914|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373915|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373916|NCT00696696|E1|Reported Event|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
373917|NCT00696436|B6|Baseline|Total|Total of all reporting groups
373918|NCT00696436|B5|Baseline|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373919|NCT00696436|B4|Baseline|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373920|NCT00696436|B3|Baseline|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373921|NCT00696436|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373922|NCT00696436|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373923|NCT00696436|P5|Participant Flow|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373924|NCT00696436|P4|Participant Flow|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373925|NCT00696436|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373926|NCT00696436|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373927|NCT00696436|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373928|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373929|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373930|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373931|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373932|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373933|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373934|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373935|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
374434|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
373936|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373937|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373938|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373939|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373940|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373941|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373942|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373943|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373944|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373945|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373946|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373947|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373948|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373949|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373950|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373951|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373952|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373953|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373954|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373955|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373956|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373957|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373958|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373959|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373960|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373961|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373962|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373963|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373964|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373965|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
378174|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
373966|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373967|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373968|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373969|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373970|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373971|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373972|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373973|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373974|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373975|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373976|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373977|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373978|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373979|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373980|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373981|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373982|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373983|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373984|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373985|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373986|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373987|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373988|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373989|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373990|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
373991|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373992|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373993|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373994|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
373995|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
378175|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
373996|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
373997|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
373998|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
373999|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
374000|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
374001|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
374002|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
374003|NCT00696436|E5|Reported Event|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
374004|NCT00696436|E4|Reported Event|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
374005|NCT00696436|E3|Reported Event|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
374006|NCT00696436|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
374007|NCT00696436|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
374008|NCT00696423|B3|Baseline|Total|Total of all reporting groups
374009|NCT00696423|B2|Baseline|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374010|NCT00696423|B1|Baseline|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374011|NCT00696423|P2|Participant Flow|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374012|NCT00696423|P1|Participant Flow|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374013|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374014|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374015|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374016|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374017|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374018|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374019|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374020|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374021|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374022|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374023|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374024|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374025|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374026|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374027|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374028|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374029|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374030|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374031|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374032|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374033|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374034|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374035|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374036|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374037|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374038|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374039|NCT00696423|E2|Reported Event|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
374040|NCT00696423|E1|Reported Event|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
374041|NCT00696384|B1|Baseline|Azilsartan Medoxomil QD - Open Label Phase|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after participant had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up or down-titrated by 1 dose level per scheduled or unscheduled visit. Baseline characteristics of this Open Label phase population are described in the table below.
374042|NCT00696384|P3|Participant Flow|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg, orally once daily or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
374043|NCT00696384|P2|Participant Flow|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks.
374044|NCT00696384|P1|Participant Flow|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
374045|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
374046|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
374047|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed and other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
374048|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
374049|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
374050|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
374051|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
374052|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
374095|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374096|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374053|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
374054|NCT00696384|E3|Reported Event|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for up to 6 weeks.
374055|NCT00696384|E2|Reported Event|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil current dose (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other antihypertensive medications as needed for 6 weeks.
374056|NCT00696384|E1|Reported Event|Azilsartan Medoxomil QD - Open Label|"Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily.. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
374057|NCT00696293|B1|Baseline|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
374058|NCT00696293|P1|Participant Flow|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
374059|NCT00696293|O1|Outcome|Duloxetine + Clinical Management|"Duloxetine + clinical management~NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
374060|NCT00696293|O1|Outcome|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
374061|NCT00696293|E1|Reported Event|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
374062|NCT00696241|B6|Baseline|Total|Total of all reporting groups
374063|NCT00696241|B5|Baseline|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374064|NCT00696241|B4|Baseline|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374065|NCT00696241|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374066|NCT00696241|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374067|NCT00696241|B1|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374068|NCT00696241|P5|Participant Flow|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374069|NCT00696241|P4|Participant Flow|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374070|NCT00696241|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374071|NCT00696241|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374072|NCT00696241|P1|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374073|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374074|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374075|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374076|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374077|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374078|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374079|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374080|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374081|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374082|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374083|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374084|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374085|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374086|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374087|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374088|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374089|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374090|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374091|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374092|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374093|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374094|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
378176|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
374097|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374098|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374099|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374100|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374101|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374102|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374103|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374104|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374105|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374106|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374107|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374108|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374109|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374110|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374111|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374112|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374113|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374114|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374115|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374116|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374117|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374118|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374119|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374120|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374121|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374122|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374123|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374124|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374125|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374126|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374127|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374128|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374129|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374130|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374131|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374132|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374133|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374134|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374135|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374136|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374137|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374138|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374139|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374140|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374141|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374142|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374143|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374144|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374145|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374146|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374147|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374148|NCT00696241|E5|Reported Event|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
374149|NCT00696241|E4|Reported Event|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
374150|NCT00696241|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
374151|NCT00696241|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
374152|NCT00696241|E1|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
374153|NCT00696072|B3|Baseline|Total|Total of all reporting groups
374154|NCT00696072|B2|Baseline|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
374155|NCT00696072|B1|Baseline|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
374156|NCT00696072|P2|Participant Flow|Letrozole|Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.
374157|NCT00696072|P1|Participant Flow|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm."
374158|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374159|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374160|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374161|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374162|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374163|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374164|NCT00696072|O1|Outcome|Crossed Over From Letrozole to Letrozole + Dasatinib|These participants were randomized to receive letrozole 2.5 mg PO once daily. After developing progressive disease they continued letrozole, and were permitted to add 100 mg PO once daily dasatinib to their treatment regimen.
374165|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374166|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374167|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374168|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374169|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
374170|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
374171|NCT00696072|E2|Reported Event|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
374172|NCT00696072|E1|Reported Event|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
374173|NCT00696020|B5|Baseline|Total|Total of all reporting groups
374174|NCT00696020|B4|Baseline|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374175|NCT00696020|B3|Baseline|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374425|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374176|NCT00696020|B2|Baseline|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374177|NCT00696020|B1|Baseline|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374178|NCT00696020|P4|Participant Flow|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374179|NCT00696020|P3|Participant Flow|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374180|NCT00696020|P2|Participant Flow|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374181|NCT00696020|P1|Participant Flow|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374182|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374183|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374184|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374185|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374186|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374187|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374188|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374189|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374190|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374191|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374192|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374193|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374194|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374195|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374196|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374197|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374198|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374199|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374200|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374201|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374202|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374203|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374426|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374204|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374205|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374206|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374207|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374208|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374209|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374210|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374211|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374212|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374213|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374214|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374215|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374216|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374217|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374218|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374219|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374220|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374221|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374222|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374223|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374224|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374225|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374226|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374227|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374228|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374229|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374230|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374231|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374232|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374435|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374233|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374234|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374235|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374236|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374237|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374238|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374239|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374240|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374241|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374242|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374243|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374244|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374245|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374246|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374247|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374248|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374249|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374250|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374251|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374252|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374253|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374254|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374255|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374256|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374257|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374258|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374259|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374260|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374261|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374436|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
374262|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374263|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374264|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374265|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374266|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374267|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374268|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374269|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374270|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374271|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374272|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374273|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374274|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374275|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374276|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374277|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374278|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374279|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374280|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374281|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374282|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374283|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374284|NCT00696020|E4|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374285|NCT00696020|E3|Reported Event|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374286|NCT00696020|E2|Reported Event|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374287|NCT00696020|E1|Reported Event|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
374288|NCT00695955|B1|Baseline|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
374427|NCT00695565|E2|Reported Event|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
374289|NCT00695955|P1|Participant Flow|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
374290|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
374291|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
374292|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
374293|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
374294|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
374295|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
374296|NCT00695955|E2|Reported Event|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
374297|NCT00695955|E1|Reported Event|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
374298|NCT00695903|B3|Baseline|Total|Total of all reporting groups
374299|NCT00695903|B2|Baseline|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374300|NCT00695903|B1|Baseline|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374301|NCT00695903|P2|Participant Flow|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374302|NCT00695903|P1|Participant Flow|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374303|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374304|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374305|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374306|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374307|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374308|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374309|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
374310|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
374311|NCT00695903|E2|Reported Event|Vancomycin|Vancomycin 15 mg/kg i.v., dosed to maintain trough serum concentrations of 15 to 20 ug/mL
374312|NCT00695903|E1|Reported Event|Daptomycin|Daptomycin 10 mg/kg i.v.q24hr
374313|NCT00695669|B5|Baseline|Total|Total of all reporting groups
374314|NCT00695669|B4|Baseline|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374315|NCT00695669|B3|Baseline|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374316|NCT00695669|B2|Baseline|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374317|NCT00695669|B1|Baseline|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374318|NCT00695669|P4|Participant Flow|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374319|NCT00695669|P3|Participant Flow|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374320|NCT00695669|P2|Participant Flow|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374321|NCT00695669|P1|Participant Flow|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374322|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374323|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374324|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374325|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374326|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374327|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374328|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374329|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374330|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374331|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374332|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374333|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374334|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374335|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374336|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374337|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374338|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374339|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374340|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374341|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374428|NCT00695565|E1|Reported Event|Placebo Gel|Placebo Gel is vehicle without clonidine
374429|NCT00695500|B3|Baseline|Total|Total of all reporting groups
374342|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374343|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374344|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374345|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374346|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374347|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374348|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374349|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374350|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374351|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374352|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374353|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374354|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374355|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374356|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374357|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374358|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374359|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374360|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374361|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374362|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374363|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374364|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374430|NCT00695500|B2|Baseline|Placebo|Placebo tablets, 0 mg per day for 3 weeks
374431|NCT00695500|B1|Baseline|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374365|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374366|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374367|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374368|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374369|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374370|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374371|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374372|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374373|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374374|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374375|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374376|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374377|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374378|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374379|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374380|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374381|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374382|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374383|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374384|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374385|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374386|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374387|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374432|NCT00695500|P2|Participant Flow|Placebo|Placebo tablets, 0 mg per day for 3 weeks
374433|NCT00695500|P1|Participant Flow|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374388|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374389|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374390|NCT00695669|E4|Reported Event|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
374391|NCT00695669|E3|Reported Event|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
374392|NCT00695669|E2|Reported Event|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
374393|NCT00695669|E1|Reported Event|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
374394|NCT00695565|B3|Baseline|Total|Total of all reporting groups
374395|NCT00695565|B2|Baseline|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
374396|NCT00695565|B1|Baseline|Placebo Gel|Placebo Gel is vehicle without clonidine
374397|NCT00695565|P2|Participant Flow|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
374398|NCT00695565|P1|Participant Flow|Placebo Gel|Placebo Gel is vehicle without clonidine
374399|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374400|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374401|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374402|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374403|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374404|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374405|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374406|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374407|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374408|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374409|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374410|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374411|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374412|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374413|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374414|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374415|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374416|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374417|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374418|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374419|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374420|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374421|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374422|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374423|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374424|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
374437|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374438|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
374439|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374440|NCT00695500|E2|Reported Event|Placebo|Placebo tablets, 0 mg per day for 3 weeks
374441|NCT00695500|E1|Reported Event|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
374442|NCT00695435|B1|Baseline|Overall Study|Overall Study
374443|NCT00695435|P3|Participant Flow|TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%|Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
374444|NCT00695435|P2|Participant Flow|Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX|Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
374445|NCT00695435|P1|Participant Flow|TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX|Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
374446|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
374447|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
374448|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
374449|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
374450|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
374451|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
374452|NCT00695435|E3|Reported Event|TOBRADEX®|TOBRADEX® Ophthalmic Suspension
374453|NCT00695435|E2|Reported Event|TOBREX®|TOBREX® Ophthalmic Solution
374454|NCT00695435|E1|Reported Event|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
374455|NCT00695396|B4|Baseline|Total|Total of all reporting groups
374456|NCT00695396|B3|Baseline|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374457|NCT00695396|B2|Baseline|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374458|NCT00695396|B1|Baseline|Placebo|(1ml or 2 mL) subcutaneously once every week
374459|NCT00695396|P3|Participant Flow|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374460|NCT00695396|P2|Participant Flow|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374461|NCT00695396|P1|Participant Flow|Placebo|(1ml or 2 mL) subcutaneously once every week
374462|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374463|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374464|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
374465|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374466|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374467|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
374468|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374469|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374470|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
374471|NCT00695396|E3|Reported Event|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
374472|NCT00695396|E2|Reported Event|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
374473|NCT00695396|E1|Reported Event|Placebo|(1ml or 2 mL) subcutaneously once every week
374474|NCT00695318|B3|Baseline|Total|Total of all reporting groups
374475|NCT00695318|B2|Baseline|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye"
374476|NCT00695318|B1|Baseline|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye"
374477|NCT00695318|P2|Participant Flow|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
374478|NCT00695318|P1|Participant Flow|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
374479|NCT00695318|O4|Outcome|A, 2, II 0.5 µg/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
374480|NCT00695318|O3|Outcome|A, 2, II Sham|
374481|NCT00695318|O2|Outcome|A, 2, I 0.2 µg/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
374482|NCT00695318|O1|Outcome|A, 2, I Sham|
374483|NCT00695318|E5|Reported Event|0.5 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection~Systemic AEs"
374484|NCT00695318|E4|Reported Event|0.2 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection~Systemic AEs"
374485|NCT00695318|E3|Reported Event|0.5 ug/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day~Ocular AEs"
374486|NCT00695318|E2|Reported Event|0.2 ug/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day~Ocular AEs"
374487|NCT00695318|E1|Reported Event|Sham Injection|"Sham Injection~Sham Injection: Sham injection~Ocular AEs"
374488|NCT00695292|B1|Baseline|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
374489|NCT00695292|P1|Participant Flow|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
374490|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
374491|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
374542|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374543|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374544|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
375017|NCT00692185|P2|Participant Flow|Placebo|Participants will take matched placebo for 16 weeks.
374492|NCT00695292|E1|Reported Event|Intervention|Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
374493|NCT00695188|B3|Baseline|Total|Total of all reporting groups
374494|NCT00695188|B2|Baseline|High Dose|Start with 25 mg MTX per week, administered orally
374495|NCT00695188|B1|Baseline|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
374496|NCT00695188|P2|Participant Flow|High Dose|Start with 25 mg MTX per week, administered orally
374497|NCT00695188|P1|Participant Flow|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
374498|NCT00695188|O2|Outcome|High Dose|Start with 25 mg MTX per week, administered orally
374499|NCT00695188|O1|Outcome|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
374500|NCT00695188|E2|Reported Event|High Dose|Start with 25 mg MTX per week, administered orally
374501|NCT00695188|E1|Reported Event|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
374502|NCT00695136|B1|Baseline|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
374503|NCT00695136|P1|Participant Flow|Open Label Single Arm|"The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.~Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study."
374504|NCT00695136|O1|Outcome|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
374505|NCT00695136|E1|Reported Event|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
374506|NCT00695097|B3|Baseline|Total|Total of all reporting groups
374507|NCT00695097|B2|Baseline|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
374508|NCT00695097|B1|Baseline|Rituximab Group|Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
374509|NCT00695097|P2|Participant Flow|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
374510|NCT00695097|P1|Participant Flow|Rituximab Group|Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
374511|NCT00695097|O2|Outcome|Control Group|No Rituximab infusion
374512|NCT00695097|O1|Outcome|Rituximab Group|Rituximab infusion day 1 and 15
374513|NCT00695097|E2|Reported Event|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only.
374514|NCT00695097|E1|Reported Event|Rituximab Group|Rituximab Group: Rituximab infusion day 1 and day 14.
374515|NCT00695019|B4|Baseline|Total|Total of all reporting groups
374516|NCT00695019|B3|Baseline|Placebo|placebo lozenges taken 3 times per day
374517|NCT00695019|B2|Baseline|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374518|NCT00695019|B1|Baseline|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
374519|NCT00695019|P3|Participant Flow|Placebo|placebo lozenges taken 3 times per day
374520|NCT00695019|P2|Participant Flow|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374521|NCT00695019|P1|Participant Flow|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
374522|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374523|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374524|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374525|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374526|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374527|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374528|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374529|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374530|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374531|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374532|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374533|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374534|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374535|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374536|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374537|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374538|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374539|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374540|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
374541|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
378177|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
374545|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374546|NCT00695019|E3|Reported Event|Placebo|placebo lozenges taken 3 times per day
374547|NCT00695019|E2|Reported Event|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
374548|NCT00695019|E1|Reported Event|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
374549|NCT00694603|B1|Baseline|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
374550|NCT00694603|P1|Participant Flow|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
374551|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
374552|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
374553|NCT00694603|E1|Reported Event|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
374554|NCT00694564|B1|Baseline|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
374555|NCT00694564|P1|Participant Flow|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
374556|NCT00694564|O1|Outcome|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
374557|NCT00694564|E1|Reported Event|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
374558|NCT00694551|B4|Baseline|Total|Total of all reporting groups
374559|NCT00694551|B3|Baseline|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374560|NCT00694551|B2|Baseline|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374561|NCT00694551|B1|Baseline|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374562|NCT00694551|P3|Participant Flow|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374563|NCT00694551|P2|Participant Flow|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374564|NCT00694551|P1|Participant Flow|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374565|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374566|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374567|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374568|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374569|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374570|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374571|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374572|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374573|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374574|NCT00694551|E3|Reported Event|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374575|NCT00694551|E2|Reported Event|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374576|NCT00694551|E1|Reported Event|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
374577|NCT00694369|B6|Baseline|Total|Total of all reporting groups
374578|NCT00694369|B5|Baseline|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
374579|NCT00694369|B4|Baseline|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
374580|NCT00694369|B3|Baseline|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
374581|NCT00694369|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
374582|NCT00694369|B1|Baseline|Placebo|Placebo orally once daily
374583|NCT00694369|P5|Participant Flow|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
374584|NCT00694369|P4|Participant Flow|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
374585|NCT00694369|P3|Participant Flow|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
374586|NCT00694369|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
374587|NCT00694369|P1|Participant Flow|Placebo|Placebo orally once daily
374588|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
374589|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
374590|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
374591|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
374592|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
374593|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
374594|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
374595|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
374596|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
374597|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
374598|NCT00694369|E5|Reported Event|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
374599|NCT00694369|E4|Reported Event|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
374600|NCT00694369|E3|Reported Event|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
374601|NCT00694369|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
374602|NCT00694369|E1|Reported Event|Placebo|Placebo orally once daily
374603|NCT00694304|B1|Baseline|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374604|NCT00694304|P1|Participant Flow|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374605|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374606|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374607|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374608|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374609|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374610|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374611|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374612|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374613|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374614|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
374615|NCT00694304|E1|Reported Event|Vortioxetine 2.5, 5, or 10 mg/Day|
374616|NCT00694161|B1|Baseline|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374617|NCT00694161|P1|Participant Flow|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374618|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374619|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374620|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374621|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374622|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374623|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374624|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374625|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374626|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374627|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374628|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374629|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374630|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374631|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374632|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374633|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374634|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374736|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
374635|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374636|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374637|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374638|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374639|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374640|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374641|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374642|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374643|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374644|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374645|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374646|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374647|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374648|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374649|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374650|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374651|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374737|NCT00693784|E1|Reported Event|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
374652|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374653|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374654|NCT00694161|E1|Reported Event|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
374655|NCT00694122|B1|Baseline|All Study Participants|"Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.~If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied"
374656|NCT00694122|P2|Participant Flow|NPH First, Then Lantus|NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
374657|NCT00694122|P1|Participant Flow|Lantus First, Then NPH|Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
374658|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
374659|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
374660|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
374661|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
374662|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
374663|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
374664|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
374665|NCT00694122|O1|Outcome|Glargine (Lantus)|glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
374666|NCT00694122|O2|Outcome|NPH Insulin|NPH was the given at 22:00 on the evening of the overnight admission.
374667|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
374668|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
374669|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
374670|NCT00694122|E2|Reported Event|Lantus Insulin|Individuals on Lantus insulin as long acting insulin.
374671|NCT00694122|E1|Reported Event|NPH Insulin|Individuals on NPH insuling as long acting insulin.
374672|NCT00694109|B1|Baseline|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374673|NCT00694109|P1|Participant Flow|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374674|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374675|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374676|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374677|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374678|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374679|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374680|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374738|NCT00693719|B1|Baseline|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
374681|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374682|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374683|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374684|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374685|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374686|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374687|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374688|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374689|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374690|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374691|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374692|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374693|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374694|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374695|NCT00694109|E1|Reported Event|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
374696|NCT00694096|B1|Baseline|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374697|NCT00694096|P1|Participant Flow|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374698|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374699|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374700|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374701|NCT00694096|E1|Reported Event|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
374702|NCT00694070|B1|Baseline|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374703|NCT00694070|P1|Participant Flow|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374704|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374705|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374706|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374707|NCT00694070|E1|Reported Event|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
374708|NCT00694018|B3|Baseline|Total|Total of all reporting groups
374829|NCT00693238|P2|Participant Flow|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
378178|NCT00683618|O1|Outcome|Rosuvastatin 10mg|Taken orally once daily
374709|NCT00694018|B2|Baseline|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
374710|NCT00694018|B1|Baseline|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
374711|NCT00694018|P2|Participant Flow|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
374712|NCT00694018|P1|Participant Flow|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
374713|NCT00694018|O2|Outcome|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
374714|NCT00694018|O1|Outcome|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
374715|NCT00694018|E2|Reported Event|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
374716|NCT00694018|E1|Reported Event|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
374717|NCT00693992|B3|Baseline|Total|Total of all reporting groups
374718|NCT00693992|B2|Baseline|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374719|NCT00693992|B1|Baseline|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374720|NCT00693992|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374721|NCT00693992|P1|Participant Flow|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374722|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374723|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374724|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374725|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374726|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374727|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374728|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374729|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374730|NCT00693992|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
374731|NCT00693992|E1|Reported Event|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
374732|NCT00693784|B1|Baseline|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
374733|NCT00693784|P1|Participant Flow|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
374734|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
374735|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
378179|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
374739|NCT00693719|P1|Participant Flow|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
374740|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
374741|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
374742|NCT00693719|E1|Reported Event|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
374743|NCT00693706|B3|Baseline|Total|Total of all reporting groups
374744|NCT00693706|B2|Baseline|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374745|NCT00693706|B1|Baseline|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374746|NCT00693706|P2|Participant Flow|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374747|NCT00693706|P1|Participant Flow|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374748|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374749|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374750|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374751|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374752|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374753|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374754|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374755|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374756|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374757|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374758|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374759|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374760|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374761|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374762|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374763|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374764|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374765|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374766|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374767|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374768|NCT00693706|E2|Reported Event|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374769|NCT00693706|E1|Reported Event|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
374770|NCT00693498|B3|Baseline|Total|Total of all reporting groups
374771|NCT00693498|B2|Baseline|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374772|NCT00693498|B1|Baseline|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374773|NCT00693498|P2|Participant Flow|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374774|NCT00693498|P1|Participant Flow|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374775|NCT00693498|O2|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374776|NCT00693498|O1|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374777|NCT00693498|E2|Reported Event|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374778|NCT00693498|E1|Reported Event|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
374779|NCT00693485|B4|Baseline|Total|Total of all reporting groups
374780|NCT00693485|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374781|NCT00693485|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374782|NCT00693485|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374783|NCT00693485|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374784|NCT00693485|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374785|NCT00693485|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374786|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374787|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374788|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374789|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374790|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374791|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374792|NCT00693485|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374793|NCT00693485|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374794|NCT00693485|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
374795|NCT00693420|B3|Baseline|Total|Total of all reporting groups
374796|NCT00693420|B2|Baseline|Vehicle Solution|
374797|NCT00693420|B1|Baseline|Bimatoprost 0.03% Solution|
374798|NCT00693420|P2|Participant Flow|Vehicle Solution|
374799|NCT00693420|P1|Participant Flow|Bimatoprost 0.03% Solution|
374800|NCT00693420|O2|Outcome|Vehicle Solution|
374801|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374802|NCT00693420|O2|Outcome|Vehicle Solution|
374803|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374804|NCT00693420|O2|Outcome|Vehicle Solution|
374805|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374806|NCT00693420|O2|Outcome|Vehicle Solution|
374807|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374808|NCT00693420|O2|Outcome|Vehicle Solution|
374809|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374810|NCT00693420|O2|Outcome|Vehicle Solution|
374811|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374812|NCT00693420|O2|Outcome|Vehicle Solution|
374813|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374814|NCT00693420|O2|Outcome|Vehicle Solution|
374815|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374816|NCT00693420|O2|Outcome|Vehicle Solution|
374817|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374818|NCT00693420|O2|Outcome|Vehicle Solution|
374819|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
374820|NCT00693420|E2|Reported Event|Vehicle Solution|
374821|NCT00693420|E1|Reported Event|Bimatoprost 0.03% Solution|
374822|NCT00693303|B1|Baseline|My Scrivener Training|Children received My Scrivenor training
374823|NCT00693303|P1|Participant Flow|My Scrivener Training|Children received My Scrivenor training
374824|NCT00693303|O1|Outcome|My Scrivener Training|Children received My Scrivenor training
374825|NCT00693303|E1|Reported Event|My Scrivener Training|Children received My Scrivenor training
374826|NCT00693238|B3|Baseline|Total|Total of all reporting groups
374827|NCT00693238|B2|Baseline|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
374828|NCT00693238|B1|Baseline|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
374830|NCT00693238|P1|Participant Flow|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
374831|NCT00693238|O2|Outcome|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
374832|NCT00693238|O1|Outcome|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
374833|NCT00693238|E2|Reported Event|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
374834|NCT00693238|E1|Reported Event|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
374835|NCT00693225|B3|Baseline|Total|Total of all reporting groups
374836|NCT00693225|B2|Baseline|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374837|NCT00693225|B1|Baseline|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374838|NCT00693225|P2|Participant Flow|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374839|NCT00693225|P1|Participant Flow|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374840|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374841|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374842|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374843|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374844|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374845|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374846|NCT00693225|E2|Reported Event|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
374847|NCT00693225|E1|Reported Event|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
374848|NCT00693160|B3|Baseline|Total|Total of all reporting groups
374849|NCT00693160|B2|Baseline|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
374850|NCT00693160|B1|Baseline|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
374851|NCT00693160|P2|Participant Flow|Placebo Intrathecal Injection|"In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
374852|NCT00693160|P1|Participant Flow|Intrathecal Ketorolac|"In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
374853|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
374854|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
374855|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
374856|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
374857|NCT00693160|E2|Reported Event|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
374858|NCT00693160|E1|Reported Event|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
374859|NCT00693017|B3|Baseline|Total|Total of all reporting groups
374860|NCT00693017|B2|Baseline|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374861|NCT00693017|B1|Baseline|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
375071|NCT00691808|B1|Baseline|High Dose|240 mg LX6171 oral suspension administered once per day
374862|NCT00693017|P2|Participant Flow|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374863|NCT00693017|P1|Participant Flow|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374864|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374865|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374866|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374867|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374868|NCT00693017|E2|Reported Event|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374869|NCT00693017|E1|Reported Event|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
374870|NCT00692913|B3|Baseline|Total|Total of all reporting groups
374871|NCT00692913|B2|Baseline|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374872|NCT00692913|B1|Baseline|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374873|NCT00692913|P2|Participant Flow|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374874|NCT00692913|P1|Participant Flow|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374875|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374876|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374877|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374878|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374879|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374880|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374881|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374882|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374883|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374884|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374885|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374886|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374887|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374888|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374889|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374890|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374891|NCT00692913|E2|Reported Event|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
374892|NCT00692913|E1|Reported Event|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
374893|NCT00692770|B3|Baseline|Total|Total of all reporting groups
374894|NCT00692770|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374895|NCT00692770|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374896|NCT00692770|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374897|NCT00692770|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374898|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374899|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374900|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374901|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374902|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374903|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374904|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374905|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374906|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374907|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374908|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374909|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374910|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374911|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374912|NCT00692770|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
374913|NCT00692770|E1|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
374914|NCT00692692|B1|Baseline|Acellular Dermal Matrix|vs control group with traditional muscle cover of tissue expander only
374915|NCT00692692|P2|Participant Flow|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
374916|NCT00692692|P1|Participant Flow|Experimental 1|"DermaMatrix acellular dermis over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
374917|NCT00692692|O2|Outcome|Experimental 1|acellular dermal matrix for total coverage of tissue expander after mastectomy for breast reconstruciton.
374918|NCT00692692|O1|Outcome|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
374919|NCT00692692|E2|Reported Event|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
374920|NCT00692692|E1|Reported Event|Experimental 1|"DermaMatrix acellular dermis over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
374921|NCT00692419|B3|Baseline|Total|Total of all reporting groups
374922|NCT00692419|B2|Baseline|Feedback Intervention|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
374923|NCT00692419|B1|Baseline|Symptom Management Intervention|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
374924|NCT00692419|P2|Participant Flow|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
374925|NCT00692419|P1|Participant Flow|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
374926|NCT00692419|O6|Outcome|Feedback Arm Change in Depression Score|Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
374927|NCT00692419|O5|Outcome|Management Group - Change in Depression Score|Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
374928|NCT00692419|O4|Outcome|Feedback Group - Change in ED Score|Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
378180|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
374929|NCT00692419|O3|Outcome|Management Group - Change in ED Score|Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
374930|NCT00692419|O2|Outcome|Feedback Group - Change in Pain Score|Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
374931|NCT00692419|O1|Outcome|Management Arm Change in Pain Score|Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
374932|NCT00692419|E2|Reported Event|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
374933|NCT00692419|E1|Reported Event|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
374934|NCT00692406|B1|Baseline|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
374935|NCT00692406|P1|Participant Flow|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
374936|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374937|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374938|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374939|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374940|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374941|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374942|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374943|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
374944|NCT00692406|E1|Reported Event|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
374945|NCT00692341|B4|Baseline|Total|Total of all reporting groups
374946|NCT00692341|B3|Baseline|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374947|NCT00692341|B2|Baseline|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374948|NCT00692341|B1|Baseline|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374949|NCT00692341|P3|Participant Flow|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374950|NCT00692341|P2|Participant Flow|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374951|NCT00692341|P1|Participant Flow|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374952|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374953|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374954|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374955|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374956|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374957|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374958|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374959|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374960|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374961|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374962|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374963|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374964|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374965|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374966|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374967|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374968|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374969|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
375072|NCT00691808|P3|Participant Flow|Placebo|Placebo dosing volume-matched and administered once per day
374970|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374971|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374972|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374973|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374974|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374975|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374976|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374977|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374978|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374979|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374980|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374981|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374982|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374983|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374984|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374985|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
375016|NCT00692185|B1|Baseline|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
374986|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374987|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374988|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374989|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374990|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374991|NCT00692341|E3|Reported Event|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
374992|NCT00692341|E2|Reported Event|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
374993|NCT00692341|E1|Reported Event|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
374994|NCT00692237|B3|Baseline|Total|Total of all reporting groups
374995|NCT00692237|B2|Baseline|Placebo|Placebo 100 mg/day (50 + 25 + 25)
374996|NCT00692237|B1|Baseline|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
374997|NCT00692237|P2|Participant Flow|Placebo|Placebo 100 mg/day (50 + 25 + 25)
374998|NCT00692237|P1|Participant Flow|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
374999|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
375000|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
375001|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
375002|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
375003|NCT00692237|E2|Reported Event|Placebo|Placebo 100 mg/day (50 + 25 + 25)
375004|NCT00692237|E1|Reported Event|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
375005|NCT00692211|B3|Baseline|Total|Total of all reporting groups
375006|NCT00692211|B2|Baseline|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
375007|NCT00692211|B1|Baseline|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
375008|NCT00692211|P2|Participant Flow|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
375009|NCT00692211|P1|Participant Flow|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
375010|NCT00692211|O2|Outcome|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
375011|NCT00692211|O1|Outcome|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
375012|NCT00692211|E2|Reported Event|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
375013|NCT00692211|E1|Reported Event|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
375014|NCT00692185|B3|Baseline|Total|Total of all reporting groups
375015|NCT00692185|B2|Baseline|Placebo|Participants will take matched placebo for 16 weeks.
375018|NCT00692185|P1|Participant Flow|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
375019|NCT00692185|O2|Outcome|Placebo|Participants will take matched placebo for 16 weeks.
375020|NCT00692185|O1|Outcome|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
375021|NCT00692185|E2|Reported Event|Placebo|Participants will take matched placebo for 16 weeks.
375022|NCT00692185|E1|Reported Event|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
375023|NCT00692003|B3|Baseline|Total|Total of all reporting groups
375024|NCT00692003|B2|Baseline|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375025|NCT00692003|B1|Baseline|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375026|NCT00692003|P2|Participant Flow|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;~>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375027|NCT00692003|P1|Participant Flow|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375028|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375029|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375030|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375031|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375032|NCT00692003|E2|Reported Event|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375033|NCT00692003|E1|Reported Event|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
375034|NCT00691938|B8|Baseline|Total|Total of all reporting groups
375035|NCT00691938|B7|Baseline|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375036|NCT00691938|B6|Baseline|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375037|NCT00691938|B5|Baseline|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375038|NCT00691938|B4|Baseline|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375039|NCT00691938|B3|Baseline|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375040|NCT00691938|B2|Baseline|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375041|NCT00691938|B1|Baseline|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375042|NCT00691938|P7|Participant Flow|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375043|NCT00691938|P6|Participant Flow|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375044|NCT00691938|P5|Participant Flow|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375045|NCT00691938|P4|Participant Flow|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375046|NCT00691938|P3|Participant Flow|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375047|NCT00691938|P2|Participant Flow|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375048|NCT00691938|P1|Participant Flow|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375049|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375050|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375051|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375052|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375053|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375073|NCT00691808|P2|Participant Flow|Low Dose|120 mg LX6171 oral suspension administered once per day
375074|NCT00691808|P1|Participant Flow|High Dose|240 mg LX6171 oral suspension administered once per day
375075|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375076|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375077|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375054|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375055|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375056|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375057|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375058|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375059|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
375060|NCT00691938|O1|Outcome|Phase I (Includes Levels 1-5)|
375061|NCT00691938|E7|Reported Event|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375062|NCT00691938|E6|Reported Event|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375063|NCT00691938|E5|Reported Event|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375064|NCT00691938|E4|Reported Event|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375065|NCT00691938|E3|Reported Event|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375066|NCT00691938|E2|Reported Event|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375067|NCT00691938|E1|Reported Event|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
375068|NCT00691808|B4|Baseline|Total|Total of all reporting groups
375069|NCT00691808|B3|Baseline|Placebo|Placebo dosing volume-matched and administered once per day
375070|NCT00691808|B2|Baseline|Low Dose|120 mg LX6171 oral suspension administered once per day
380049|NCT00677365|O1|Outcome|Placebo|Placebo Group
375078|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375079|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375080|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375081|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375082|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375083|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375084|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375085|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375086|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375087|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375088|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375089|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375090|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375091|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375092|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375093|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375094|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375095|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375096|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375097|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375098|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375099|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375100|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375101|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375102|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375103|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375104|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375105|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375106|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375107|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375108|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
375109|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
375110|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
375111|NCT00691808|E3|Reported Event|Placebo|Placebo dosing volume-matched and administered once per day
375112|NCT00691808|E2|Reported Event|Low Dose|120 mg LX6171 oral suspension administered once per day
375113|NCT00691808|E1|Reported Event|High Dose|240 mg LX6171 oral suspension administered once per day
375114|NCT00691704|B1|Baseline|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Maintenance Therapy: Subjects who achieve >partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance:~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on Days 1-7~Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21."
375115|NCT00691704|P1|Participant Flow|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375116|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375170|NCT00691327|E1|Reported Event|Reconstruction|Women who have undergone Breast Reconstruction
375171|NCT00691210|B9|Baseline|Total|Total of all reporting groups
375172|NCT00691210|B8|Baseline|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375117|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375118|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375119|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375120|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375121|NCT00691704|E1|Reported Event|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
375122|NCT00691665|B3|Baseline|Total|Total of all reporting groups
375123|NCT00691665|B2|Baseline|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375124|NCT00691665|B1|Baseline|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375125|NCT00691665|P2|Participant Flow|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375126|NCT00691665|P1|Participant Flow|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375127|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375128|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375129|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375130|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375131|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375132|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375133|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375134|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375135|NCT00691665|E2|Reported Event|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
375136|NCT00691665|E1|Reported Event|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
375173|NCT00691210|B7|Baseline|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375137|NCT00691652|B1|Baseline|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
375138|NCT00691652|P1|Participant Flow|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
375139|NCT00691652|O1|Outcome|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
375140|NCT00691652|E1|Reported Event|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
375141|NCT00691483|B3|Baseline|Total|Total of all reporting groups
375142|NCT00691483|B2|Baseline|Placebo|Placebo matched to varenicline.
375143|NCT00691483|B1|Baseline|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375144|NCT00691483|P2|Participant Flow|Placebo|Placebo matched to varenicline.
375145|NCT00691483|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375146|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375147|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375148|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375149|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375150|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375151|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375152|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375153|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375154|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375155|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375156|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
375157|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375158|NCT00691483|E2|Reported Event|Placebo|Placebo matched to varenicline.
375159|NCT00691483|E1|Reported Event|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
375160|NCT00691327|B3|Baseline|Total|Total of all reporting groups
375161|NCT00691327|B2|Baseline|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
375162|NCT00691327|B1|Baseline|Reconstruction|Women who have undergone Breast Reconstruction
375163|NCT00691327|P2|Participant Flow|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
375164|NCT00691327|P1|Participant Flow|Reconstruction|Women who have undergone Breast Reconstruction
375165|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
375166|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
375167|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
375168|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
375169|NCT00691327|E2|Reported Event|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
375174|NCT00691210|B6|Baseline|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375175|NCT00691210|B5|Baseline|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375176|NCT00691210|B4|Baseline|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375177|NCT00691210|B3|Baseline|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375178|NCT00691210|B2|Baseline|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375179|NCT00691210|B1|Baseline|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375180|NCT00691210|P8|Participant Flow|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375181|NCT00691210|P7|Participant Flow|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375182|NCT00691210|P6|Participant Flow|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375183|NCT00691210|P5|Participant Flow|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375184|NCT00691210|P4|Participant Flow|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375185|NCT00691210|P3|Participant Flow|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375186|NCT00691210|P2|Participant Flow|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375187|NCT00691210|P1|Participant Flow|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375188|NCT00691210|O2|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1-2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375189|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1-5|"Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375190|NCT00691210|O7|Outcome|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375191|NCT00691210|O6|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375192|NCT00691210|O5|Outcome|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375193|NCT00691210|O4|Outcome|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375194|NCT00691210|O3|Outcome|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375195|NCT00691210|O2|Outcome|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375196|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375197|NCT00691210|E7|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375198|NCT00691210|E6|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
375199|NCT00691210|E5|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375200|NCT00691210|E4|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375201|NCT00691210|E3|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375202|NCT00691210|E2|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375203|NCT00691210|E1|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
375204|NCT00691197|B3|Baseline|Total|Total of all reporting groups
375205|NCT00691197|B2|Baseline|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375206|NCT00691197|B1|Baseline|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375207|NCT00691197|P2|Participant Flow|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375208|NCT00691197|P1|Participant Flow|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375209|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375210|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375211|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375212|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375213|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375214|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375215|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375216|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375217|NCT00691197|E2|Reported Event|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
375218|NCT00691197|E1|Reported Event|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
375219|NCT00691093|B1|Baseline|Fesoterodine 4 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
375220|NCT00691093|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
375221|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 mg or 8 mg
375222|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
375223|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375224|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375225|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375226|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375227|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375228|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375229|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375230|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375231|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375232|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375233|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375234|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375235|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375236|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375237|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375238|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375239|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375240|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375241|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375242|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375243|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375244|NCT00691093|O1|Outcome|All Subjects|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
375245|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
375246|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375247|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375248|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375249|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
375250|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
375251|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
375252|NCT00691093|E1|Reported Event|Fesoterodine 4 mg or 8 mg|All Subjects
375253|NCT00691054|B1|Baseline|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375254|NCT00691054|P1|Participant Flow|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375255|NCT00691054|O1|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375256|NCT00691054|O1|Outcome|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375257|NCT00691054|O1|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375258|NCT00691054|O1|Outcome|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375259|NCT00691054|O1|Outcome|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375260|NCT00691054|E1|Reported Event|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
375261|NCT00691028|B4|Baseline|Total|Total of all reporting groups
375262|NCT00691028|B3|Baseline|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375263|NCT00691028|B2|Baseline|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375264|NCT00691028|B1|Baseline|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375265|NCT00691028|P4|Participant Flow|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
375266|NCT00691028|P3|Participant Flow|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375267|NCT00691028|P2|Participant Flow|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375268|NCT00691028|P1|Participant Flow|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375374|NCT00690755|E3|Reported Event|Group 3|Control (non-diabetic)
375269|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375270|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375271|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375272|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375273|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375274|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375275|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375276|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375277|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375278|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375279|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375280|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14..
375281|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375282|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14..
375283|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375284|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14..
375285|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375286|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375287|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375288|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375289|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375290|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375291|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375292|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375293|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375294|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375295|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375296|NCT00691028|E4|Reported Event|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
375297|NCT00691028|E3|Reported Event|TA-650 10 mg/kg (Double-blind)|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
375298|NCT00691028|E2|Reported Event|TA-650 6 mg/kg (Double-blind)|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
375299|NCT00691028|E1|Reported Event|TA-650 3 mg/kg (Double-blind)|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
375300|NCT00690898|B1|Baseline|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375301|NCT00690898|P1|Participant Flow|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375302|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375303|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375304|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375305|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375306|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375307|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375308|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375375|NCT00690755|E2|Reported Event|Group 2|Type 1 diabetes
375376|NCT00690755|E1|Reported Event|Group 1|Diabetics
375309|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375310|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375311|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375312|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375313|NCT00690898|E1|Reported Event|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
375314|NCT00690820|B3|Baseline|Total|Total of all reporting groups
375315|NCT00690820|B2|Baseline|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
375316|NCT00690820|B1|Baseline|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
375317|NCT00690820|P2|Participant Flow|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
375318|NCT00690820|P1|Participant Flow|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
375319|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375320|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375321|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375322|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375323|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375324|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375325|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375326|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375327|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375328|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375329|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375330|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375331|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375332|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375333|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375334|NCT00690820|O1|Outcome|Placebo|Placebo treatment
375335|NCT00690820|E2|Reported Event|Pancrelipase|Pancrelipase delayed release 12000 units treatment
375336|NCT00690820|E1|Reported Event|Placebo|Placebo treatment
375337|NCT00690794|B3|Baseline|Total|Total of all reporting groups
375338|NCT00690794|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
375339|NCT00690794|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
375340|NCT00690794|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
375341|NCT00690794|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
375342|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
375343|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
375344|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
375345|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
375346|NCT00690794|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
375347|NCT00690794|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
375348|NCT00690755|B8|Baseline|Total|Total of all reporting groups
375349|NCT00690755|B7|Baseline|Group 7|Non-Diabetic treated with Metformin
375350|NCT00690755|B6|Baseline|Group 6|Impaired glucose tolerance (IGT)
375351|NCT00690755|B5|Baseline|Group 5|Non-Diabetic and Type 2 Diabetic subjected to exercise study
375352|NCT00690755|B4|Baseline|Group 4|Non-Diabetic Overweight
375353|NCT00690755|B3|Baseline|Group 3|Control (non-diabetic)
375354|NCT00690755|B2|Baseline|Group 2|Type 1 Diabetic
375355|NCT00690755|B1|Baseline|Group 1|Type 2 diabetic
375356|NCT00690755|P7|Participant Flow|Group 7|Non-diabetic treated with Metformin
375357|NCT00690755|P6|Participant Flow|Group 6|Impaired glucose tolerance (IGT)
375358|NCT00690755|P5|Participant Flow|Group 5|Non-diabetic and Type 2 diabetic
375359|NCT00690755|P4|Participant Flow|Group 4|Non-diabetic overweight
375360|NCT00690755|P3|Participant Flow|Group 3|Control (non-diabetic)
375361|NCT00690755|P2|Participant Flow|Group 2|Type 1 diabetic
375362|NCT00690755|P1|Participant Flow|Group 1|Type 2 diabetic
375363|NCT00690755|O7|Outcome|Group 7|Non-diabetic treated with Metformin
375364|NCT00690755|O6|Outcome|Group 6|Impaired glucose tolerance (IGT)
375365|NCT00690755|O5|Outcome|Group 5|Non-diabetic and Type 2 diabetic
375366|NCT00690755|O4|Outcome|Group 4|Non-diabetic overweight
375367|NCT00690755|O3|Outcome|Group 3|Control (non-diabetic)
375368|NCT00690755|O2|Outcome|Group 2|Type 1 diabetic
375369|NCT00690755|O1|Outcome|Group 1|Type 2 diabetic
375370|NCT00690755|E7|Reported Event|Group 7|Non-diabetic treated with Metformin
375371|NCT00690755|E6|Reported Event|Group 6|Impaired glucose tolerance (IGT)
375372|NCT00690755|E5|Reported Event|Group 5|Non-diabetic and Type 2 diabetic
375373|NCT00690755|E4|Reported Event|Group 4|Non-diabetic overweight
375377|NCT00690612|B1|Baseline|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
375378|NCT00690612|P1|Participant Flow|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
375379|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
375380|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
375381|NCT00690612|E1|Reported Event|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
375382|NCT00690573|B1|Baseline|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375383|NCT00690573|P1|Participant Flow|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375384|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375385|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375386|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375387|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375388|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375389|NCT00690573|E1|Reported Event|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
375390|NCT00690495|B3|Baseline|Total|Total of all reporting groups
375391|NCT00690495|B2|Baseline|Propofol 1%|Propofol 1%
375392|NCT00690495|B1|Baseline|Modified Propofol|Modified propofol (Propofol 0.5%)
375393|NCT00690495|P2|Participant Flow|Propofol 1%|Propofol 1%
375394|NCT00690495|P1|Participant Flow|Modified Propofol|Modified propofol (Propofol 0.5%)
375395|NCT00690495|O2|Outcome|Propofol 1%|Propofol 1%
375396|NCT00690495|O1|Outcome|Modified Propofol|Modified propofol (Propofol 0.5%)
375397|NCT00690495|E2|Reported Event|Propofol 1%|Propofol 1%
375398|NCT00690495|E1|Reported Event|Modified Propofol|Modified propofol (Propofol 0.5%)
375399|NCT00690482|B3|Baseline|Total|Total of all reporting groups
375400|NCT00690482|B2|Baseline|Placebo|Placebo Oral tablet, twice daily
375401|NCT00690482|B1|Baseline|AZD1981|AZD1981 Oral tablet, twice daily
375402|NCT00690482|P2|Participant Flow|Placebo|Placebo Oral tablet, twice daily
375403|NCT00690482|P1|Participant Flow|AZD1981|AZD1981 Oral tablet, twice daily
375404|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375405|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375406|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375407|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375408|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375409|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375410|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375411|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375412|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375413|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375414|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375415|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375416|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375417|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375418|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375419|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375420|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375421|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375422|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375423|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375424|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375425|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375426|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375427|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375428|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375429|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375430|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
375431|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
375432|NCT00690482|E2|Reported Event|Placebo|Placebo Oral tablet, twice daily
375433|NCT00690482|E1|Reported Event|AZD1981|AZD1981 Oral tablet, twice daily
375434|NCT00690443|B3|Baseline|Total|Total of all reporting groups
375435|NCT00690443|B2|Baseline|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
375436|NCT00690443|B1|Baseline|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
375437|NCT00690443|P2|Participant Flow|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
375438|NCT00690443|P1|Participant Flow|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
375439|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
375440|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
375441|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
375442|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
375443|NCT00690443|E2|Reported Event|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
375444|NCT00690443|E1|Reported Event|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
375445|NCT00690430|B3|Baseline|Total|Total of all reporting groups
375446|NCT00690430|B2|Baseline|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375447|NCT00690430|B1|Baseline|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375448|NCT00690430|P3|Participant Flow|Extension: Octreotide LAR/Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
375449|NCT00690430|P2|Participant Flow|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375450|NCT00690430|P1|Participant Flow|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375451|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375452|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375453|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375454|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375455|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375456|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375457|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375516|NCT00689871|P4|Participant Flow|Revision-reconstruction|All women implanted for revision of a breast reconstruction
375517|NCT00689871|P3|Participant Flow|Revision-augmentation|All women implanted for revision of a breast augmentation
375458|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375459|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375460|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375461|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375462|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375463|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375464|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375465|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375466|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375467|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375468|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375469|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375470|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375471|NCT00690430|E5|Reported Event|Crossover to Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
375472|NCT00690430|E4|Reported Event|Extension Phase Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375518|NCT00689871|P2|Participant Flow|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
375473|NCT00690430|E3|Reported Event|Extension Phase Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375474|NCT00690430|E2|Reported Event|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
375475|NCT00690430|E1|Reported Event|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
375476|NCT00690339|B5|Baseline|Total|Total of all reporting groups
375477|NCT00690339|B4|Baseline|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375478|NCT00690339|B3|Baseline|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375479|NCT00690339|B2|Baseline|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375480|NCT00690339|B1|Baseline|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375481|NCT00690339|P4|Participant Flow|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375482|NCT00690339|P3|Participant Flow|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375483|NCT00690339|P2|Participant Flow|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375484|NCT00690339|P1|Participant Flow|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375485|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375486|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375487|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375488|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375489|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375490|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375491|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375492|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375493|NCT00690339|E4|Reported Event|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375494|NCT00690339|E3|Reported Event|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375495|NCT00690339|E2|Reported Event|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375496|NCT00690339|E1|Reported Event|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
375497|NCT00690040|B3|Baseline|Total|Total of all reporting groups
375498|NCT00690040|B2|Baseline|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
375499|NCT00690040|B1|Baseline|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
375500|NCT00690040|P2|Participant Flow|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
375501|NCT00690040|P1|Participant Flow|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
375502|NCT00690040|O2|Outcome|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
375503|NCT00690040|O1|Outcome|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
375504|NCT00690040|E2|Reported Event|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
375505|NCT00690040|E1|Reported Event|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
375506|NCT00689884|B1|Baseline|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
375507|NCT00689884|P1|Participant Flow|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
375508|NCT00689884|O1|Outcome|Group 1|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
375509|NCT00689884|O1|Outcome|Chemotherapy Plus Pegfilgrastim|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
375510|NCT00689884|E1|Reported Event|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
375511|NCT00689871|B5|Baseline|Total|Total of all reporting groups
375512|NCT00689871|B4|Baseline|Revision-reconstruction|All women implanted for revision of a breast reconstruction
375513|NCT00689871|B3|Baseline|Revision-augmentation|All women implanted for revision of a breast augmentation
375514|NCT00689871|B2|Baseline|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
375515|NCT00689871|B1|Baseline|Primary Augmentation|All women implanted for an indication of primary breast augmentation
375519|NCT00689871|P1|Participant Flow|Primary Augmentation|All women implanted for an indication of primary breast augmentation
375520|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
375521|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
375522|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
375523|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
375524|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
375525|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
375526|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
375527|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
375528|NCT00689871|E4|Reported Event|Revision-reconstruction|All women implanted for revision of a breast reconstruction
375529|NCT00689871|E3|Reported Event|Revision-augmentation|All women implanted for revision of a breast augmentation
375530|NCT00689871|E2|Reported Event|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
375531|NCT00689871|E1|Reported Event|Primary Augmentation|All women implanted for an indication of primary breast augmentation
375532|NCT00689819|B3|Baseline|Total|Total of all reporting groups
375533|NCT00689819|B2|Baseline|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
375534|NCT00689819|B1|Baseline|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
375535|NCT00689819|P2|Participant Flow|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
375536|NCT00689819|P1|Participant Flow|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
375537|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
375538|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
375539|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
375540|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
375541|NCT00689819|E2|Reported Event|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
375542|NCT00689819|E1|Reported Event|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
375543|NCT00689793|B3|Baseline|Total|Total of all reporting groups
375544|NCT00689793|B2|Baseline|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375545|NCT00689793|B1|Baseline|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375546|NCT00689793|P2|Participant Flow|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375547|NCT00689793|P1|Participant Flow|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375548|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375549|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375550|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375551|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375552|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375553|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375554|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375555|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375556|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375557|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily), during one month.
375558|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
375559|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375560|NCT00689793|E2|Reported Event|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
375561|NCT00689793|E1|Reported Event|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
375562|NCT00689611|B3|Baseline|Total|Total of all reporting groups
375563|NCT00689611|B2|Baseline|Bupropion|"participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
375564|NCT00689611|B1|Baseline|Placebo|"participants received placebo for 9 weeks.~Placebo: Placebo"
375565|NCT00689611|P2|Participant Flow|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."
375566|NCT00689611|P1|Participant Flow|Placebo|Participants received placebo for 9 weeks.
375567|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
375568|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
375569|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
375570|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
375571|NCT00689611|E2|Reported Event|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
375572|NCT00689611|E1|Reported Event|Placebo|Participants received placebo for 9 weeks.
375573|NCT00689481|B3|Baseline|Total|Total of all reporting groups
375574|NCT00689481|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375575|NCT00689481|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375576|NCT00689481|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375577|NCT00689481|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375578|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375579|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375580|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375581|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375582|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375583|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375584|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375585|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375586|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375587|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375588|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375589|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375590|NCT00689481|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375591|NCT00689481|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
375592|NCT00689390|B3|Baseline|Total|Total of all reporting groups
375593|NCT00689390|B2|Baseline|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375594|NCT00689390|B1|Baseline|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375595|NCT00689390|P2|Participant Flow|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375596|NCT00689390|P1|Participant Flow|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375623|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
381217|NCT00673452|P2|Participant Flow|Placebo|oral, daily, 12 weeks
375597|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375598|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375599|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375600|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375601|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375602|NCT00689390|O1|Outcome|Participants From Boceprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375603|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
375604|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
375605|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
375606|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
375607|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
375608|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
375609|NCT00689390|E2|Reported Event|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
375610|NCT00689390|E1|Reported Event|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
375611|NCT00689351|B3|Baseline|Total|Total of all reporting groups
375612|NCT00689351|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375613|NCT00689351|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375614|NCT00689351|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375615|NCT00689351|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375616|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375617|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375618|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375619|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375620|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375621|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375622|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
381222|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
375624|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375625|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375626|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375627|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375628|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375629|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375630|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375631|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375632|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375633|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375634|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375635|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375636|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375637|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375638|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375639|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
375640|NCT00689351|E6|Reported Event|Toddler Dose 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
375641|NCT00689351|E5|Reported Event|Toddler Dose 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
375642|NCT00689351|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
375643|NCT00689351|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
375644|NCT00689351|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
375645|NCT00689351|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
375646|NCT00689338|B1|Baseline|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375647|NCT00689338|P1|Participant Flow|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375648|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375649|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375650|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375651|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375652|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375718|NCT00689117|B3|Baseline|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375653|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375654|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375655|NCT00689338|E1|Reported Event|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
375656|NCT00689299|B4|Baseline|Total|Total of all reporting groups
375657|NCT00689299|B3|Baseline|2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F|Active Dose Group B
375658|NCT00689299|B2|Baseline|0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (|Active Dose Group A
375659|NCT00689299|B1|Baseline|Placebo|Placebo - Dose Group C
375660|NCT00689299|P3|Participant Flow|0.21 Units Fel d 1|"Active Dose Group A~From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
375661|NCT00689299|P2|Participant Flow|2.1 Units Fel d 1|"Active Dose Group B~From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
375662|NCT00689299|P1|Participant Flow|Placebo|Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
375663|NCT00689299|O3|Outcome|2.1 Units Standardized Allergenic Extract, Cat Hair|Dose Group B
375664|NCT00689299|O2|Outcome|0.21 Units Standardized Allergenic Extract, Cat Hair|Dose Group A
375665|NCT00689299|O1|Outcome|Placebo|Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
375666|NCT00689299|E3|Reported Event|Dose Group B|2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
375667|NCT00689299|E2|Reported Event|Dose Group A|0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
375668|NCT00689299|E1|Reported Event|Dose Group C|placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
375669|NCT00689260|B3|Baseline|Total|Total of all reporting groups
375670|NCT00689260|B2|Baseline|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
375671|NCT00689260|B1|Baseline|Log Aware|Dose Log Aware and Daily Diary Enabled
375672|NCT00689260|P2|Participant Flow|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
375673|NCT00689260|P1|Participant Flow|Log Aware|Dose Log Aware and Daily Diary Enabled
375674|NCT00689260|O3|Outcome|Total|
375675|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
375676|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
375677|NCT00689260|O3|Outcome|Total|
375678|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
375679|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
375680|NCT00689260|O3|Outcome|Total|
375681|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
375682|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
375683|NCT00689260|O3|Outcome|Total|
375684|NCT00689260|O2|Outcome|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
375685|NCT00689260|O1|Outcome|Log Aware|Dose Log Aware and Daily Diary Enabled
375686|NCT00689260|E2|Reported Event|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
375687|NCT00689260|E1|Reported Event|Log Aware|Dose Log Aware and Daily Diary Enabled
375688|NCT00689221|B3|Baseline|Total|Total of all reporting groups
375689|NCT00689221|B2|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375690|NCT00689221|B1|Baseline|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375691|NCT00689221|P2|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375692|NCT00689221|P1|Participant Flow|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375719|NCT00689117|B2|Baseline|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375693|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375694|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375695|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375696|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375697|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375698|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375699|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375700|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375701|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375702|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375703|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375704|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375757|NCT00689104|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375705|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375706|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375707|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375708|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375709|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375710|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375711|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375712|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375713|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
375714|NCT00689221|E2|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
375715|NCT00689221|E1|Reported Event|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator,
375716|NCT00689117|B5|Baseline|Total|Total of all reporting groups
375717|NCT00689117|B4|Baseline|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375720|NCT00689117|B1|Baseline|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375721|NCT00689117|P4|Participant Flow|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375722|NCT00689117|P3|Participant Flow|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375723|NCT00689117|P2|Participant Flow|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375724|NCT00689117|P1|Participant Flow|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375725|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375726|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375727|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375728|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375729|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375730|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375731|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375732|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375733|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375734|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375735|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375736|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375737|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375738|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375739|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375740|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375741|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375742|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375743|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375744|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375745|NCT00689117|E4|Reported Event|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375746|NCT00689117|E3|Reported Event|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375747|NCT00689117|E2|Reported Event|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375748|NCT00689117|E1|Reported Event|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
375749|NCT00689104|B5|Baseline|Total|Total of all reporting groups
375750|NCT00689104|B4|Baseline|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375751|NCT00689104|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375752|NCT00689104|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375753|NCT00689104|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375754|NCT00689104|P4|Participant Flow|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375755|NCT00689104|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375756|NCT00689104|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375836|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375758|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375759|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375760|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375761|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375762|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375763|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375764|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375765|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375766|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375767|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375768|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375769|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375770|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375771|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375772|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375773|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375774|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375775|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375776|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375777|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375778|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375779|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375780|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375781|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375782|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375783|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375784|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375785|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375786|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375787|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375788|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375789|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375790|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375791|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375792|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375793|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375794|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375795|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375796|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375920|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375797|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375798|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375799|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375800|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375801|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375802|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375803|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375804|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375805|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375806|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375807|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375808|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375809|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375810|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375811|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375812|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375813|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375814|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375815|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375816|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375817|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375818|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375819|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375820|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375821|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375822|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375823|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375824|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375825|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375826|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375827|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375828|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375829|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375830|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375831|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375832|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375833|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375834|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375835|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
381223|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
375837|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375838|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375839|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375840|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375841|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375842|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375843|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375844|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375845|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375846|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375847|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375848|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375849|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375850|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375851|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375852|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375853|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375854|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375855|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375856|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375857|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375858|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375859|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375860|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375861|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375862|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375863|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375864|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375865|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375866|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375867|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375868|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375869|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375870|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375871|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375872|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375873|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375874|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375875|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
381224|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
375876|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375877|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375878|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375879|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375880|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375881|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375882|NCT00689104|E4|Reported Event|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
375883|NCT00689104|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375884|NCT00689104|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
375885|NCT00689104|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
375886|NCT00689091|B3|Baseline|Total|Total of all reporting groups
375887|NCT00689091|B2|Baseline|Minimum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375888|NCT00689091|B1|Baseline|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375889|NCT00689091|P2|Participant Flow|Minimum Anesthesia Contration Alert|"This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375890|NCT00689091|P1|Participant Flow|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375891|NCT00689091|O2|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375892|NCT00689091|O1|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375893|NCT00689091|E2|Reported Event|Miniumum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375894|NCT00689091|E1|Reported Event|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
375895|NCT00689052|B3|Baseline|Total|Total of all reporting groups
375896|NCT00689052|B2|Baseline|Pramipexole|Patients receiving pramipexole
375897|NCT00689052|B1|Baseline|Placebo|Patients receiving matching placebo
375898|NCT00689052|P2|Participant Flow|Pramipexole|Patients receive pramipexole in dose up-titration steps
375899|NCT00689052|P1|Participant Flow|Placebo|Patients receive placebo in dose up-titration steps
375900|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375901|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375902|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375903|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375904|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375905|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375906|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375907|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375908|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375909|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375910|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375911|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375912|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375913|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375914|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375915|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375916|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375917|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375918|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375919|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
381225|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
375921|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375922|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
375923|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375924|NCT00689052|O2|Outcome|Pramipexole|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
375925|NCT00689052|O1|Outcome|Placebo|Placebo tablets, once daily in the evening
375926|NCT00689052|E2|Reported Event|Pramipexole|
375927|NCT00689052|E1|Reported Event|Placebo|
375928|NCT00689026|B3|Baseline|Total|Total of all reporting groups
375929|NCT00689026|B2|Baseline|Control|PEG colon cleansing
375930|NCT00689026|B1|Baseline|Experimental|PEG plus lubiprostone colon cleansing
375931|NCT00689026|P2|Participant Flow|Control|Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
375932|NCT00689026|P1|Participant Flow|Experimental|Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
375933|NCT00689026|O2|Outcome|Control|All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
375934|NCT00689026|O1|Outcome|Experimental|Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).
375935|NCT00689026|E2|Reported Event|Control|Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
375936|NCT00689026|E1|Reported Event|Treatment|Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading
375937|NCT00688870|B3|Baseline|Total|Total of all reporting groups
375938|NCT00688870|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375939|NCT00688870|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375940|NCT00688870|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375941|NCT00688870|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375942|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375943|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375944|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375945|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375972|NCT00688844|B1|Baseline|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375973|NCT00688844|P1|Participant Flow|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375946|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375947|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375948|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375949|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375950|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375951|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375952|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375953|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375954|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375955|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375956|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375957|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375974|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375975|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375958|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375959|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375960|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375961|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375962|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375963|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375964|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375965|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375966|NCT00688870|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
375967|NCT00688870|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
375968|NCT00688870|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375969|NCT00688870|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375970|NCT00688870|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
375971|NCT00688870|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
381226|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
375976|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375977|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375978|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375979|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375980|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375981|NCT00688844|E1|Reported Event|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
375982|NCT00688753|B1|Baseline|RAD001 10 mg|two 5 mg tablets of everolimus orally, once daily
375983|NCT00688753|P1|Participant Flow|RAD001|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
375984|NCT00688753|O1|Outcome|RAD001|10 mg/day
375985|NCT00688753|O1|Outcome|RAD001|10 mg/day
375986|NCT00688753|O1|Outcome|RAD001|10 mg/day
375987|NCT00688753|O1|Outcome|RAD001|10 mg/day
375988|NCT00688753|O1|Outcome|RAD001|10 mg/day
375989|NCT00688753|O1|Outcome|RAD001|10 mg/day
375990|NCT00688753|E1|Reported Event|All Patients|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
375991|NCT00688740|B3|Baseline|Total|Total of all reporting groups
375992|NCT00688740|B2|Baseline|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
375993|NCT00688740|B1|Baseline|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
375994|NCT00688740|P2|Participant Flow|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
375995|NCT00688740|P1|Participant Flow|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
375996|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
375997|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
375998|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
375999|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
376000|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
376001|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
376002|NCT00688740|E2|Reported Event|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
376003|NCT00688740|E1|Reported Event|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
376004|NCT00688701|B4|Baseline|Total|Total of all reporting groups
376005|NCT00688701|B3|Baseline|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
376006|NCT00688701|B2|Baseline|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
376007|NCT00688701|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376008|NCT00688701|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
376009|NCT00688701|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
376010|NCT00688701|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
376011|NCT00688701|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
376012|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376013|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376014|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376015|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376016|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376017|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376018|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376019|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376020|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376021|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376022|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376023|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376024|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376025|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376026|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376027|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376028|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376029|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376030|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376031|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376032|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376033|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376034|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376035|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376036|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376037|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376038|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376039|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376040|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376041|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376042|NCT00688701|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
376043|NCT00688701|E5|Reported Event|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
376044|NCT00688701|E4|Reported Event|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
376045|NCT00688701|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
376046|NCT00688701|E2|Reported Event|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo.
376047|NCT00688701|E1|Reported Event|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo.
376048|NCT00688688|B4|Baseline|Total|Total of all reporting groups
376049|NCT00688688|B3|Baseline|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376050|NCT00688688|B2|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376051|NCT00688688|B1|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376052|NCT00688688|P3|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376053|NCT00688688|P2|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376054|NCT00688688|P1|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376055|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376056|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376057|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376058|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376059|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376060|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376061|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376062|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376063|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376064|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376065|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376066|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376067|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376068|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376738|NCT00686842|O1|Outcome|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
376069|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376070|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376071|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376072|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376073|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376074|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376075|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376076|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376077|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376078|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376079|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376080|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376081|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376082|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376083|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376084|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376085|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376086|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376087|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376088|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376089|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376090|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376091|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376092|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376093|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376094|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376095|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376096|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376097|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376098|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376099|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376100|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376101|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376102|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376103|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376104|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376105|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376106|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376107|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376108|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376109|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376110|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376111|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376112|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376113|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376114|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376115|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376116|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376117|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376118|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376119|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376120|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376121|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376122|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376123|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376124|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376125|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376126|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376127|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376128|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376129|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376130|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376131|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376132|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376133|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376134|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376135|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376136|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376137|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376138|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376139|NCT00688688|E3|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
376140|NCT00688688|E2|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
376141|NCT00688688|E1|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
376142|NCT00688662|B3|Baseline|Total|Total of all reporting groups
376143|NCT00688662|B2|Baseline|2. ERCP Without Sphincterotomy|Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
376144|NCT00688662|B1|Baseline|1. ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
376145|NCT00688662|P2|Participant Flow|2. ERCP Without Sphincterotomy:|Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
376146|NCT00688662|P1|Participant Flow|1.ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
376147|NCT00688662|O2|Outcome|2.ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
376148|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
376149|NCT00688662|O2|Outcome|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
376150|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
376151|NCT00688662|E2|Reported Event|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
376152|NCT00688662|E1|Reported Event|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
376153|NCT00688636|B3|Baseline|Total|Total of all reporting groups
376154|NCT00688636|B2|Baseline|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376155|NCT00688636|B1|Baseline|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376156|NCT00688636|P2|Participant Flow|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376157|NCT00688636|P1|Participant Flow|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376158|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376159|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376160|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376161|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376162|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376163|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376164|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376165|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376166|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376167|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
376168|NCT00688636|E2|Reported Event|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376169|NCT00688636|E1|Reported Event|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
376170|NCT00688545|B3|Baseline|Total|Total of all reporting groups
376171|NCT00688545|B2|Baseline|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376172|NCT00688545|B1|Baseline|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376173|NCT00688545|P2|Participant Flow|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376174|NCT00688545|P1|Participant Flow|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376175|NCT00688545|O2|Outcome|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376176|NCT00688545|O1|Outcome|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
376177|NCT00688545|O2|Outcome|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376178|NCT00688545|O1|Outcome|Celecoxib|Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376179|NCT00688545|E2|Reported Event|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376739|NCT00686842|E1|Reported Event|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
376180|NCT00688545|E1|Reported Event|Celecoxib|Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
376181|NCT00688519|B3|Baseline|Total|Total of all reporting groups
376182|NCT00688519|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376183|NCT00688519|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376184|NCT00688519|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376185|NCT00688519|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376186|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376187|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376188|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376189|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376190|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376191|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376192|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376193|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376194|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376195|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376196|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376197|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376198|NCT00688519|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376199|NCT00688519|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
376200|NCT00688467|B3|Baseline|Total|Total of all reporting groups
376201|NCT00688467|B2|Baseline|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
376202|NCT00688467|B1|Baseline|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
376203|NCT00688467|P2|Participant Flow|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
376204|NCT00688467|P1|Participant Flow|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
376205|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376206|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376207|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376208|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376209|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376210|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376211|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376212|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376213|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376214|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376215|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376216|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376217|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376218|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376219|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376220|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376221|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376222|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376223|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376224|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376225|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376226|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376227|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376228|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376229|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376230|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376231|NCT00688467|E2|Reported Event|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376232|NCT00688467|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
376233|NCT00688103|B3|Baseline|Total|Total of all reporting groups
376234|NCT00688103|B2|Baseline|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
376235|NCT00688103|B1|Baseline|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
376236|NCT00688103|P2|Participant Flow|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
376237|NCT00688103|P1|Participant Flow|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
376238|NCT00688103|O2|Outcome|ETN+MTX|"etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)~ETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)"
376239|NCT00688103|O1|Outcome|ETN Alone|"etanercept (25mg, twice/week, s.c.)~ETN Alone: etanercept (25 mg, twice/week, s.c.)"
376240|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
376241|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
376242|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
376243|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
376244|NCT00688103|E2|Reported Event|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
376245|NCT00688103|E1|Reported Event|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
376246|NCT00688064|B3|Baseline|Total|Total of all reporting groups
376247|NCT00688064|B2|Baseline|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376248|NCT00688064|B1|Baseline|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376249|NCT00688064|P2|Participant Flow|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376250|NCT00688064|P1|Participant Flow|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376251|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376252|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376253|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376254|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376255|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376256|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376257|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376258|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376259|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376260|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376261|NCT00688064|E2|Reported Event|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
376262|NCT00688064|E1|Reported Event|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
376263|NCT00687973|B3|Baseline|Total|Total of all reporting groups
376264|NCT00687973|B2|Baseline|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376265|NCT00687973|B1|Baseline|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376266|NCT00687973|P2|Participant Flow|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376393|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376267|NCT00687973|P1|Participant Flow|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376268|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376269|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376270|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376271|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376272|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376273|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376274|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376275|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376276|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376277|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376278|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376279|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376280|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376281|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376282|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376283|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376284|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376285|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376286|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376287|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376288|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376289|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376740|NCT00686803|B4|Baseline|Total|Total of all reporting groups
376290|NCT00687973|E3|Reported Event|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376291|NCT00687973|E2|Reported Event|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
376292|NCT00687973|E1|Reported Event|Amlodipine 5 mg|Run-in: Amlodipine 5 mg
376293|NCT00687908|B3|Baseline|Total|Total of all reporting groups
376294|NCT00687908|B2|Baseline|Vehicle|Vehicle Gel
376295|NCT00687908|B1|Baseline|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376296|NCT00687908|P2|Participant Flow|Vehicle|Vehicle Gel
376297|NCT00687908|P1|Participant Flow|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376298|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
376299|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376300|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
376301|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376302|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
376303|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376304|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
376305|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376306|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
376307|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376308|NCT00687908|E2|Reported Event|Vehicle|Vehicle Gel
376309|NCT00687908|E1|Reported Event|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
376310|NCT00687856|B1|Baseline|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
376311|NCT00687856|P1|Participant Flow|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
376312|NCT00687856|O1|Outcome|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
376313|NCT00687856|E1|Reported Event|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
376314|NCT00687830|B3|Baseline|Total|Total of all reporting groups
376315|NCT00687830|B2|Baseline|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
376316|NCT00687830|B1|Baseline|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
376317|NCT00687830|P2|Participant Flow|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
376318|NCT00687830|P1|Participant Flow|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
376319|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
376320|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
376321|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
376322|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
376323|NCT00687830|E2|Reported Event|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
376324|NCT00687830|E1|Reported Event|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
376325|NCT00687804|B4|Baseline|Total|Total of all reporting groups
376326|NCT00687804|B3|Baseline|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376327|NCT00687804|B2|Baseline|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376394|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376395|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376396|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376328|NCT00687804|B1|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376329|NCT00687804|P3|Participant Flow|Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376330|NCT00687804|P2|Participant Flow|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376331|NCT00687804|P1|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376332|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376333|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376334|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376357|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376335|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376336|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376337|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376338|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376339|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376340|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376341|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376380|NCT00687713|E2|Reported Event|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
376381|NCT00687713|E1|Reported Event|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
376342|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376343|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376344|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376345|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376346|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376347|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376348|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376382|NCT00687674|B1|Baseline|Sorafenib + Lenalidomide + Dexamethasone|
376383|NCT00687674|P1|Participant Flow|Sorafenib + Lenalidomide + Dexamethasone|
376384|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
376385|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
376386|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
376349|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376350|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376351|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376352|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376353|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376354|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376355|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376356|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376387|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
376388|NCT00687674|E1|Reported Event|Sorafenib + Lenalidomide + Dexamethasone|
376358|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376359|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376360|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376361|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376362|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376363|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376364|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376365|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376366|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376389|NCT00687609|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376390|NCT00687609|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376391|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376367|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376368|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
376369|NCT00687804|E4|Reported Event|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376370|NCT00687804|E3|Reported Event|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376371|NCT00687804|E2|Reported Event|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy"
376372|NCT00687804|E1|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
376373|NCT00687713|B3|Baseline|Total|Total of all reporting groups
376374|NCT00687713|B2|Baseline|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
376375|NCT00687713|B1|Baseline|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
376376|NCT00687713|P2|Participant Flow|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
376377|NCT00687713|P1|Participant Flow|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
376378|NCT00687713|O2|Outcome|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
376379|NCT00687713|O1|Outcome|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
376392|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376397|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376398|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376399|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376400|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376401|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376402|NCT00687609|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
376403|NCT00687544|B1|Baseline|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376404|NCT00687544|P1|Participant Flow|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376405|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376406|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376407|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376408|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376409|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376410|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376411|NCT00687544|E1|Reported Event|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
376412|NCT00687531|B1|Baseline|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376413|NCT00687531|P1|Participant Flow|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376414|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376415|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376416|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376417|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376418|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376419|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376420|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376421|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376422|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376423|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376424|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376425|NCT00687531|E1|Reported Event|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
376426|NCT00687453|B3|Baseline|Total|Total of all reporting groups
376427|NCT00687453|B2|Baseline|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
376428|NCT00687453|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376429|NCT00687453|P2|Participant Flow|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
376430|NCT00687453|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376431|NCT00687453|O2|Outcome|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
376432|NCT00687453|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376433|NCT00687453|E2|Reported Event|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
376434|NCT00687453|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376435|NCT00687440|B1|Baseline|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
376436|NCT00687440|P1|Participant Flow|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
376537|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376437|NCT00687440|O1|Outcome|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
376438|NCT00687440|E1|Reported Event|Caelyx, Docetaxel, Trastuzumab|
376439|NCT00687401|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
376440|NCT00687401|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
376441|NCT00687401|O2|Outcome|Per Protocol Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
376442|NCT00687401|O1|Outcome|Intent to Treat Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
376443|NCT00687401|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
376444|NCT00687362|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
376445|NCT00687362|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
376446|NCT00687362|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
376447|NCT00687362|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
376448|NCT00687323|B1|Baseline|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376449|NCT00687323|P1|Participant Flow|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376450|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376451|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376452|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376453|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376454|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376455|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376456|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376457|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376458|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376459|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376538|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376460|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376461|NCT00687323|E1|Reported Event|TEMOZOLOMIDE|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
376462|NCT00687297|B3|Baseline|Total|Total of all reporting groups
376463|NCT00687297|B2|Baseline|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
376464|NCT00687297|B1|Baseline|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
376465|NCT00687297|P2|Participant Flow|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
376466|NCT00687297|P1|Participant Flow|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
376467|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
376468|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
376469|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
376470|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
376471|NCT00687297|O1|Outcome|All Randomized Patients|All patients enrolled in the study
376472|NCT00687297|E3|Reported Event|All Treated Patients - Induction|Adverse events occurring during induction among all treated patients
376473|NCT00687297|E2|Reported Event|Treated on Placebo Maintenance|Adverse events among patients receiving placebo during the maintenance phase of the study
376474|NCT00687297|E1|Reported Event|Treated on Vandetanib Maintenance|Adverse events among patients receiving Vandetanib using the maintenance phase of the study
376475|NCT00687219|B1|Baseline|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376476|NCT00687219|P1|Participant Flow|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376477|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376478|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376479|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376480|NCT00687219|E1|Reported Event|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
376481|NCT00687193|B7|Baseline|Total|Total of all reporting groups
376482|NCT00687193|B6|Baseline|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376483|NCT00687193|B5|Baseline|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376484|NCT00687193|B4|Baseline|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376485|NCT00687193|B3|Baseline|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376486|NCT00687193|B2|Baseline|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376681|NCT00686998|P2|Participant Flow|Placebo|Matching Placebo
376487|NCT00687193|B1|Baseline|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376488|NCT00687193|P6|Participant Flow|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376489|NCT00687193|P5|Participant Flow|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376490|NCT00687193|P4|Participant Flow|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376491|NCT00687193|P3|Participant Flow|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376492|NCT00687193|P2|Participant Flow|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376493|NCT00687193|P1|Participant Flow|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376494|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376495|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376496|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376497|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376498|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376499|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376500|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376501|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376502|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376503|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376504|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376505|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376506|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376507|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376508|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376509|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376510|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376511|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376512|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376513|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376514|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376515|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376516|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376517|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376518|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376519|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376520|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376521|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376522|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376523|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376524|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376525|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376526|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376527|NCT00687193|O3|Outcome|CP-690,550 5 mg BID|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376528|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376529|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376530|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376531|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376532|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376533|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376534|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376535|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
376536|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376539|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376540|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376541|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376542|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376543|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376544|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376545|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376546|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376547|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376548|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376549|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376550|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376551|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376552|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376553|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376554|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376555|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376556|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376557|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376558|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376559|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376560|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376561|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376562|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376563|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376564|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376565|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376566|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376567|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376568|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376569|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376570|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376571|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376572|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376573|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376574|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376575|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376576|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376577|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376578|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376579|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376580|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376581|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376582|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376583|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376584|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376585|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376586|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376587|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376588|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376589|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376590|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376591|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376592|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376593|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376594|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376595|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376596|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376597|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376598|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376599|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376600|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376601|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376602|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376603|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376604|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376605|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376606|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376607|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376608|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376609|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376610|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376611|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376612|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376613|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376614|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376615|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376616|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376617|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376618|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376619|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
376620|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376621|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376622|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376623|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376624|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376625|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376626|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376627|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376628|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376629|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376630|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376631|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376632|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376633|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376634|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376635|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376636|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376637|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376638|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376639|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376682|NCT00686998|P1|Participant Flow|AZD2624|AZD2624 40 mg
376640|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376641|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376642|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376643|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376644|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376645|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376646|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376647|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376648|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376649|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376650|NCT00687193|E6|Reported Event|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
376651|NCT00687193|E5|Reported Event|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
376652|NCT00687193|E4|Reported Event|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
376653|NCT00687193|E3|Reported Event|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
376654|NCT00687193|E2|Reported Event|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
376655|NCT00687193|E1|Reported Event|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
376656|NCT00687167|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
376657|NCT00687167|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
376658|NCT00687167|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
376659|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
376660|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
376661|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
376662|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
376663|NCT00687167|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
376664|NCT00687167|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
376665|NCT00687076|B3|Baseline|Total|Total of all reporting groups
376666|NCT00687076|B2|Baseline|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376683|NCT00686998|O3|Outcome|Olanzapine|Olanzapine 15 mg
376684|NCT00686998|O2|Outcome|Placebo|Placebo
376685|NCT00686998|O1|Outcome|AZD2624|AZD2624 40 mg
376686|NCT00686998|E3|Reported Event|Olanzapine|Olanzapine 15 mg
376667|NCT00687076|B1|Baseline|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376668|NCT00687076|P2|Participant Flow|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376669|NCT00687076|P1|Participant Flow|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376670|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376671|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376672|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376673|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376674|NCT00687076|E2|Reported Event|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376675|NCT00687076|E1|Reported Event|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
376676|NCT00686998|B4|Baseline|Total|Total of all reporting groups
376677|NCT00686998|B3|Baseline|Olanzapine|Olanzapine 15 mg
376678|NCT00686998|B2|Baseline|Placebo|Matching Placebo
376679|NCT00686998|B1|Baseline|AZD2624|AZD2624 40 mg
376680|NCT00686998|P3|Participant Flow|Olanzapine|Olanzapine 15 mg
376690|NCT00686959|B2|Baseline|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376691|NCT00686959|B1|Baseline|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376692|NCT00686959|P2|Participant Flow|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376693|NCT00686959|P1|Participant Flow|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.~Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376694|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376695|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376696|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376697|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376741|NCT00686803|B3|Baseline|Placebo|Placebo
376742|NCT00686803|B2|Baseline|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
376743|NCT00686803|B1|Baseline|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
376744|NCT00686803|P3|Participant Flow|Placebo|Placebo
376745|NCT00686803|P2|Participant Flow|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
376746|NCT00686803|P1|Participant Flow|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
376747|NCT00686803|O3|Outcome|Placebo|Placebo
376748|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
376698|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376699|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376700|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376701|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376702|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376703|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376704|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376705|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376749|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
376750|NCT00686803|O3|Outcome|Placebo|Placebo
376751|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
376752|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
376753|NCT00686803|E3|Reported Event|Placebo|Placebo
376754|NCT00686803|E2|Reported Event|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
376755|NCT00686803|E1|Reported Event|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
376756|NCT00686790|B1|Baseline|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376757|NCT00686790|P1|Participant Flow|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376706|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
376707|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
376708|NCT00686959|E2|Reported Event|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase"
376709|NCT00686959|E1|Reported Event|Arm A:|"Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT (”Concurrent Phase”) for three 21-day cycles, followed by a 3-5 week “Recovery Period,” then treated with consolidation chemotherapy with pemetrexed (”Consolidation Phase”) for four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles."
376710|NCT00686894|B1|Baseline|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
376711|NCT00686894|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
376712|NCT00686894|O1|Outcome|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
376713|NCT00686894|E1|Reported Event|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
376714|NCT00686881|B3|Baseline|Total|Total of all reporting groups
376715|NCT00686881|B2|Baseline|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
376716|NCT00686881|B1|Baseline|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
376717|NCT00686881|P2|Participant Flow|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
376718|NCT00686881|P1|Participant Flow|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
376719|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
376720|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
376721|NCT00686881|O2|Outcome|SNMC|Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
376722|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
376723|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
376724|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
376725|NCT00686881|E2|Reported Event|SNMC|"Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up~to 156 weeks."
376726|NCT00686881|E1|Reported Event|PegIFN-2b|"Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for~up to 156 weeks."
376727|NCT00686855|B3|Baseline|Total|Total of all reporting groups
376728|NCT00686855|B2|Baseline|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
376729|NCT00686855|B1|Baseline|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
376730|NCT00686855|P2|Participant Flow|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
376731|NCT00686855|P1|Participant Flow|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
376732|NCT00686855|O2|Outcome|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
376733|NCT00686855|O1|Outcome|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
376734|NCT00686855|E2|Reported Event|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
376735|NCT00686855|E1|Reported Event|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
376736|NCT00686842|B1|Baseline|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
376737|NCT00686842|P1|Participant Flow|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
376758|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376759|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376760|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376761|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376762|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376763|NCT00686790|E1|Reported Event|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
376764|NCT00686777|B1|Baseline|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376765|NCT00686777|P1|Participant Flow|Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376766|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376767|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376768|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376769|NCT00686777|E1|Reported Event|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
376770|NCT00686725|B3|Baseline|Total|Total of all reporting groups
376771|NCT00686725|B2|Baseline|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376772|NCT00686725|B1|Baseline|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376773|NCT00686725|P2|Participant Flow|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376774|NCT00686725|P1|Participant Flow|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376775|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376776|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376777|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376778|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376779|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376780|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376781|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376782|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376783|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376784|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376785|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376786|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376787|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
381227|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
376788|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376789|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376790|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376791|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376792|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
376793|NCT00686725|E2|Reported Event|Temozolomide Alone, Then Temozolomide Radiation|Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
376794|NCT00686725|E1|Reported Event|Temozolomide Radiation|Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
376795|NCT00686712|B4|Baseline|Total|Total of all reporting groups
376796|NCT00686712|B3|Baseline|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
376797|NCT00686712|B2|Baseline|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
376798|NCT00686712|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376799|NCT00686712|P3|Participant Flow|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
376800|NCT00686712|P2|Participant Flow|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
376801|NCT00686712|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376802|NCT00686712|O3|Outcome|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
376803|NCT00686712|O2|Outcome|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
376804|NCT00686712|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376805|NCT00686712|E3|Reported Event|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
376806|NCT00686712|E2|Reported Event|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
376807|NCT00686712|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
376808|NCT00686699|B3|Baseline|Total|Total of all reporting groups
376809|NCT00686699|B2|Baseline|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
376810|NCT00686699|B1|Baseline|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule BID for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
376811|NCT00686699|P2|Participant Flow|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
376812|NCT00686699|P1|Participant Flow|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
376813|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376814|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376815|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376816|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376817|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376818|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376819|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376820|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376821|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376822|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376823|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376824|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376825|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376826|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376827|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376828|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376829|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376830|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376831|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376832|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376833|NCT00686699|E2|Reported Event|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
376834|NCT00686699|E1|Reported Event|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
376835|NCT00686686|B1|Baseline|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376836|NCT00686686|P1|Participant Flow|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376837|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376838|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376839|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376840|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376841|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376842|NCT00686686|E1|Reported Event|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
376843|NCT00686647|B1|Baseline|AngioSculpt Device|
376844|NCT00686647|P1|Participant Flow|AngioSculpt Device|
376845|NCT00686647|O1|Outcome|AngioSculpt Device|
376846|NCT00686647|O1|Outcome|AngioSculpt Device|
376847|NCT00686647|O1|Outcome|Overall Study|
376848|NCT00686647|E1|Reported Event|AngioSculpt Device|
376849|NCT00686634|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg once daily
376850|NCT00686634|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg orally once daily
376851|NCT00686634|O1|Outcome|Sitagliptin|Any adverse events while receiving sitagliptin
376852|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
376853|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
376854|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
376855|NCT00686634|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg once daily
376856|NCT00686595|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376857|NCT00686595|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376858|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376859|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376860|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376933|NCT00686517|E1|Reported Event|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376861|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376862|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376863|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376864|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376865|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376866|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376867|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376868|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376869|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376870|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376871|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376872|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376873|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376874|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376875|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376876|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376877|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376878|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376879|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376880|NCT00686595|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
376881|NCT00686543|B5|Baseline|Total|Total of all reporting groups
376882|NCT00686543|B4|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
376883|NCT00686543|B3|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
376884|NCT00686543|B2|Baseline|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
376885|NCT00686543|B1|Baseline|Not Randomized|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
376886|NCT00686543|P4|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
376887|NCT00686543|P3|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
376888|NCT00686543|P2|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
376889|NCT00686543|P1|Participant Flow|Not Randomized|Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
376890|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
376891|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
376934|NCT00686335|B1|Baseline|Safety Population|all patients that started the run-in period with Cortancyl®
376892|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
376893|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
376894|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
376895|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
376896|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
376897|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
376898|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
376899|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
376900|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
376901|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
376902|NCT00686543|E4|Reported Event|POS 400 mg TID on Days 9-15|POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
376903|NCT00686543|E3|Reported Event|POS 400 mg BID on Days 9-15|POS 400 mg on Days 9-15, administered with food or oral nutritional supplements.
376904|NCT00686543|E2|Reported Event|POS 200 mg TID on Days 9-15|POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
376905|NCT00686543|E1|Reported Event|POS 200 mg TID on Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements.
376906|NCT00686517|B4|Baseline|Total|Total of all reporting groups
376907|NCT00686517|B3|Baseline|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376908|NCT00686517|B2|Baseline|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376909|NCT00686517|B1|Baseline|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376910|NCT00686517|P3|Participant Flow|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376911|NCT00686517|P2|Participant Flow|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376912|NCT00686517|P1|Participant Flow|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376913|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376914|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376915|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376916|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376917|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376918|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376919|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376920|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376921|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376922|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376923|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376924|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376925|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376926|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376927|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376928|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376929|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
376930|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
376931|NCT00686517|E3|Reported Event|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
376932|NCT00686517|E2|Reported Event|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
381228|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
376935|NCT00686335|P1|Participant Flow|Safety Population|all patients that started the run-in period with Cortancyl®
376936|NCT00686335|O2|Outcome|Cortancyl|immediate release prednisone
376937|NCT00686335|O1|Outcome|Lodotra|modified release prednisone
376938|NCT00686335|E2|Reported Event|Cortancyl|immediate release prednisone
376939|NCT00686335|E1|Reported Event|Lodotra|modified release prednisone
376940|NCT00686257|B3|Baseline|Total|Total of all reporting groups
376941|NCT00686257|B2|Baseline|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
376942|NCT00686257|B1|Baseline|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
376943|NCT00686257|P2|Participant Flow|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
376944|NCT00686257|P1|Participant Flow|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
376945|NCT00686257|O2|Outcome|Total Face Mask|Received Total Face Mask
376946|NCT00686257|O1|Outcome|Control|Received standard face mask
376947|NCT00686257|E2|Reported Event|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
376948|NCT00686257|E1|Reported Event|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
376949|NCT00686231|B4|Baseline|Total|Total of all reporting groups
376950|NCT00686231|B3|Baseline|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
376951|NCT00686231|B2|Baseline|Lidocaine|Lidocaine 1 inch
376952|NCT00686231|B1|Baseline|Placebo|Sorbolene cream
376953|NCT00686231|P3|Participant Flow|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
376954|NCT00686231|P2|Participant Flow|Lidocaine|Lidocaine 1 inch
376955|NCT00686231|P1|Participant Flow|Placebo|Sorbolene cream
376956|NCT00686231|O3|Outcome|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
376957|NCT00686231|O2|Outcome|Lidocaine|Lidocaine 1 inch
376958|NCT00686231|O1|Outcome|Placebo|Sorbolene cream
376959|NCT00686231|E3|Reported Event|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
376960|NCT00686231|E2|Reported Event|Lidocaine|Lidocaine 1 inch
376961|NCT00686231|E1|Reported Event|Placebo|Sorbolene cream
376962|NCT00686205|B3|Baseline|Total|Total of all reporting groups
376963|NCT00686205|B2|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
376964|NCT00686205|B1|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
376965|NCT00686205|P2|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
376966|NCT00686205|P1|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
376967|NCT00686205|O1|Outcome|HIV Positive Samples|Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.
376968|NCT00686205|O1|Outcome|HIV Negative Donors|Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
376969|NCT00686205|E2|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
376970|NCT00686205|E1|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
376971|NCT00686166|B1|Baseline|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
376972|NCT00686166|P1|Participant Flow|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
376973|NCT00686166|O3|Outcome|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
376974|NCT00686166|O2|Outcome|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
376975|NCT00686166|O1|Outcome|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
377010|NCT00686075|P1|Participant Flow|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377011|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
376976|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
376977|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
376978|NCT00686166|E3|Reported Event|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
376979|NCT00686166|E2|Reported Event|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
376980|NCT00686166|E1|Reported Event|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
376981|NCT00686127|B3|Baseline|Total|Total of all reporting groups
376982|NCT00686127|B2|Baseline|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
376983|NCT00686127|B1|Baseline|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
376984|NCT00686127|P2|Participant Flow|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
376985|NCT00686127|P1|Participant Flow|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
376986|NCT00686127|O2|Outcome|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
376987|NCT00686127|O1|Outcome|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
376988|NCT00686127|E2|Reported Event|Placebo Patch|Placebo patch: Patch is changed every 24 hours
376989|NCT00686127|E1|Reported Event|Lidocaine Patch|Lidocaine patch One patch is changed every twenty-four hours
376990|NCT00686075|B11|Baseline|Total|Total of all reporting groups
376991|NCT00686075|B10|Baseline|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
376992|NCT00686075|B9|Baseline|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
376993|NCT00686075|B8|Baseline|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
376994|NCT00686075|B7|Baseline|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
376995|NCT00686075|B6|Baseline|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
376996|NCT00686075|B5|Baseline|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
376997|NCT00686075|B4|Baseline|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
376998|NCT00686075|B3|Baseline|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
376999|NCT00686075|B2|Baseline|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377000|NCT00686075|B1|Baseline|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377001|NCT00686075|P10|Participant Flow|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377002|NCT00686075|P9|Participant Flow|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377003|NCT00686075|P8|Participant Flow|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377004|NCT00686075|P7|Participant Flow|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377005|NCT00686075|P6|Participant Flow|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377006|NCT00686075|P5|Participant Flow|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377007|NCT00686075|P4|Participant Flow|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377008|NCT00686075|P3|Participant Flow|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377009|NCT00686075|P2|Participant Flow|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377012|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377013|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377014|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377015|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377016|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377017|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377018|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377019|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377020|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377021|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377022|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377023|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377024|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377025|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377026|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377027|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377028|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377029|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377030|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377031|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377032|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377033|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377034|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377035|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377036|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377037|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377038|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377039|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377040|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377041|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377042|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377043|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377044|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377045|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377046|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377047|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377048|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377049|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377050|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377051|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377052|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
381229|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
377053|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377054|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377055|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377056|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377057|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377058|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377059|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377060|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377061|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377062|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377063|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377064|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377065|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377066|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377067|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377068|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377069|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377070|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377071|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377072|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377073|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377074|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377075|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377076|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377077|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377078|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377079|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377080|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377081|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377082|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377083|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377084|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377085|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377086|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377087|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377088|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377089|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377090|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377091|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377092|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377093|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
381230|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
377094|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377095|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377096|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377097|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377098|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377099|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377100|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377101|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377102|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377103|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377104|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377105|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377106|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377107|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377108|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377109|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377110|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377111|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377112|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377113|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377114|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377115|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377116|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377117|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377118|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377119|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377120|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377121|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377122|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377123|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377124|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377125|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377126|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377127|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377128|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377129|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377130|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377131|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377132|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377133|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377134|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
381231|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
377135|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377136|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377137|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377138|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377139|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377140|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377141|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377142|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377143|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377144|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377145|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377146|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377147|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377148|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377149|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377150|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377151|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377152|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377153|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377154|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377155|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377156|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377157|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377158|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377159|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377160|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377161|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377162|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377163|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377164|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377165|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377166|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377167|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377168|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377169|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377170|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377171|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377172|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377173|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377174|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377175|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
381232|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
377176|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377177|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377178|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377179|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377180|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377181|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377182|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377183|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377184|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377185|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377186|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377187|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377188|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377189|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377190|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377191|NCT00686075|E10|Reported Event|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377192|NCT00686075|E9|Reported Event|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377193|NCT00686075|E8|Reported Event|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377194|NCT00686075|E7|Reported Event|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377195|NCT00686075|E6|Reported Event|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377196|NCT00686075|E5|Reported Event|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
377197|NCT00686075|E4|Reported Event|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377198|NCT00686075|E3|Reported Event|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
377199|NCT00686075|E2|Reported Event|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
377200|NCT00686075|E1|Reported Event|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
377201|NCT00686036|B3|Baseline|Total|Total of all reporting groups
377202|NCT00686036|B2|Baseline|Placebo|Placebo to match vandetanib 300 mg tablet
377203|NCT00686036|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet
377204|NCT00686036|P2|Participant Flow|Placebo|Placebo to match vandetanib 300 mg tablet
377205|NCT00686036|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet
377206|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
377207|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
377208|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
377209|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
377210|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
377211|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
377212|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
377213|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
377214|NCT00686036|E2|Reported Event|Placebo|Placebo to match vandetanib 300 mg tablet
377215|NCT00686036|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet
377216|NCT00685945|B1|Baseline|All Participants|Subjects characteristics for all 24 participants
377217|NCT00685945|P1|Participant Flow|All Participants|24 subjects received a bradykinin infusion and then a bradykinin + L-NMMA infusion. Subjects were then randomized to receive either isosorbide (N=12) or sildenafil (N=12). The infusion of bradykinin + L-NMMA was then repeated.
377218|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
377219|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
377220|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
377221|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
377222|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
377223|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
377224|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
377225|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
377226|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve of the twenty-four subjects were randomized to sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
377227|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Eleven of the twenty-four subjects were randomized to isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
377228|NCT00685945|O2|Outcome|L-NMMA + Control|After the intial bradykinin infusion subjects then received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
377229|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
377230|NCT00685945|E1|Reported Event|All Participants|Subjects characteristics for all 24 participants
377231|NCT00685880|B3|Baseline|Total|Total of all reporting groups
377232|NCT00685880|B2|Baseline|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
377233|NCT00685880|B1|Baseline|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
377234|NCT00685880|P2|Participant Flow|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
377235|NCT00685880|P1|Participant Flow|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
377236|NCT00685880|O2|Outcome|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
377237|NCT00685880|O1|Outcome|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
377238|NCT00685880|E2|Reported Event|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
377239|NCT00685880|E1|Reported Event|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
377240|NCT00685802|B1|Baseline|Cilostazol 50 mg Tablets and Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
377241|NCT00685802|P2|Participant Flow|Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.
377242|NCT00685802|P1|Participant Flow|Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
377243|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377244|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377245|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377246|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377247|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377248|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377249|NCT00685802|E2|Reported Event|Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
377250|NCT00685802|E1|Reported Event|Cilostazol 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
377251|NCT00685763|B1|Baseline|Proton Radiation and Chemotherapy|Unresectable Carcinoma of the Pancreas
377538|NCT00684593|B2|Baseline|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
377252|NCT00685763|P1|Participant Flow|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
377253|NCT00685763|O1|Outcome|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
377254|NCT00685763|E1|Reported Event|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
377255|NCT00685698|B1|Baseline|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377256|NCT00685698|P1|Participant Flow|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377257|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377258|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377259|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377260|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377261|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377262|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377263|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377264|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377265|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377266|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377267|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377268|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377269|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377270|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377271|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377272|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377273|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377274|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377275|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377276|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377277|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377278|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377279|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377280|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377281|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377282|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377283|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377284|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377285|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377286|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377287|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377288|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377289|NCT00685698|E1|Reported Event|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
377290|NCT00685685|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
377291|NCT00685685|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
377292|NCT00685685|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
377293|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377294|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377295|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377296|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377297|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377298|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377299|NCT00685685|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
377300|NCT00685685|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
377301|NCT00685659|B4|Baseline|Total|Total of all reporting groups
377302|NCT00685659|B3|Baseline|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
377303|NCT00685659|B2|Baseline|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
377304|NCT00685659|B1|Baseline|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
377305|NCT00685659|P3|Participant Flow|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
377306|NCT00685659|P2|Participant Flow|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
377307|NCT00685659|P1|Participant Flow|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
377308|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
377309|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
377310|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
377311|NCT00685659|E3|Reported Event|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
377312|NCT00685659|E2|Reported Event|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
377313|NCT00685659|E1|Reported Event|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
377314|NCT00685516|B4|Baseline|Total|Total of all reporting groups
377315|NCT00685516|B3|Baseline|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377316|NCT00685516|B2|Baseline|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377317|NCT00685516|B1|Baseline|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377318|NCT00685516|P3|Participant Flow|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377319|NCT00685516|P2|Participant Flow|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377320|NCT00685516|P1|Participant Flow|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377321|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377322|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377323|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377324|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377325|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377326|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377327|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377328|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377329|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377330|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
377331|NCT00685516|O2|Outcome|Arm II - Water|Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
377332|NCT00685516|O1|Outcome|Arm I - Green Tea|Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
377333|NCT00685516|E3|Reported Event|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
377334|NCT00685516|E2|Reported Event|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
377335|NCT00685516|E1|Reported Event|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
377336|NCT00685477|B1|Baseline|All Study Participants|CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
377337|NCT00685477|P6|Participant Flow|Experimental Sequence CBA|Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
377338|NCT00685477|P5|Participant Flow|Experimental Sequence CAB|Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes
377339|NCT00685477|P4|Participant Flow|Experimental Sequence BCA|Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes
377340|NCT00685477|P3|Participant Flow|Experimental Sequence BAC|Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes
377341|NCT00685477|P2|Participant Flow|Experimental Sequence ACB|Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes
377342|NCT00685477|P1|Participant Flow|Experimental Sequence ABC|Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes
377343|NCT00685477|O3|Outcome|60 Minute Infusion|Drug given over 60 minutes
377344|NCT00685477|O2|Outcome|30 Minute Infusion|Drug given over 30 minutes
377345|NCT00685477|O1|Outcome|15 Minute Infusion|Drug given over 15 minutes
377346|NCT00685477|O3|Outcome|60 Min Infusion|Drug given over 60 minutes infusion
377347|NCT00685477|O2|Outcome|30 Min Infusion|Drug given over 30 minutes infusion
377348|NCT00685477|O1|Outcome|15min Infusion|Drug given over 15 minutes infusion
377349|NCT00685477|E1|Reported Event|All Study Participants|Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
377350|NCT00685373|B1|Baseline|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377351|NCT00685373|P1|Participant Flow|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377352|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377353|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377354|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377355|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377356|NCT00685373|E1|Reported Event|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
377357|NCT00685334|B3|Baseline|Total|Total of all reporting groups
377358|NCT00685334|B2|Baseline|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
377359|NCT00685334|B1|Baseline|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
377360|NCT00685334|P2|Participant Flow|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
377361|NCT00685334|P1|Participant Flow|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
377362|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
377363|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
377364|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
377365|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
377366|NCT00685334|E2|Reported Event|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
377495|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377367|NCT00685334|E1|Reported Event|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
377368|NCT00685295|B3|Baseline|Total|Total of all reporting groups
377369|NCT00685295|B2|Baseline|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
377370|NCT00685295|B1|Baseline|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
377371|NCT00685295|P2|Participant Flow|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
377372|NCT00685295|P1|Participant Flow|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
377373|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|"Active Comparator Group:~Subject receives:~Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill~Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet~Lansoprazole: lansoprazole 15mg rapidly dissolving tablet~Oxycodone: Oxycodone 5/325 mg tablet"
377374|NCT00685295|O1|Outcome|Arm 1 / Fentora|"Intervention Group:~Subject receives:~placebo oral/swallowed pill~Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet~Fentanyl: Fentanyl rapid dissolving tablet 100mcg"
377375|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
377376|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
377377|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
377378|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
377379|NCT00685295|E2|Reported Event|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
377380|NCT00685295|E1|Reported Event|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
377381|NCT00685165|B1|Baseline|Primidone 50 mg Tablets and Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
377382|NCT00685165|P2|Participant Flow|Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
377383|NCT00685165|P1|Participant Flow|Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
377384|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
377385|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
377386|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
377387|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
377388|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
377389|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
377390|NCT00685165|E2|Reported Event|Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
377391|NCT00685165|E1|Reported Event|Primidone 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
377392|NCT00685139|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
377393|NCT00685139|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast.
377394|NCT00685139|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast.
377395|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
377396|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
377496|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377397|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
377398|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
377399|NCT00685139|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
377400|NCT00685139|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran 100 mg following an overnight fast.
377401|NCT00685035|B1|Baseline|All Study Participants|"Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period~VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects"
377402|NCT00685035|P2|Participant Flow|Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq|HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention).
377403|NCT00685035|P1|Participant Flow|Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq|HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention).
377404|NCT00685035|O4|Outcome|Perceived Effectiveness Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
377405|NCT00685035|O3|Outcome|Perceived Effectiveness Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
377406|NCT00685035|O2|Outcome|Perceived Comfort Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
377407|NCT00685035|O1|Outcome|Perceived Comfort Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
377408|NCT00685035|O8|Outcome|"G Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377409|NCT00685035|O7|Outcome|"G Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377410|NCT00685035|O6|Outcome|"G Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377411|NCT00685035|O5|Outcome|"G Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377412|NCT00685035|O4|Outcome|G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377413|NCT00685035|O3|Outcome|G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377414|NCT00685035|O2|Outcome|G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377415|NCT00685035|O1|Outcome|G' Storage Modulus at 1 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
377416|NCT00685035|O4|Outcome|Change in FVC Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
377417|NCT00685035|O3|Outcome|Change in FVC Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
377418|NCT00685035|O2|Outcome|Change in FEV1 Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
377419|NCT00685035|O1|Outcome|Change in FEV1 Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
377420|NCT00685035|O4|Outcome|Sputum Dry Weight Lower Pressure/Mid-frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
377444|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
377497|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377421|NCT00685035|O3|Outcome|Sputum Dry Weight Higher Pressure/Variable Frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
377422|NCT00685035|O2|Outcome|Sputum Wet Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
377423|NCT00685035|O1|Outcome|Sputum Wet Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
377424|NCT00685035|E2|Reported Event|Higher Pressure/Variable Frequency|
377425|NCT00685035|E1|Reported Event|Lower Pressure/Mid-frequency|
377426|NCT00684996|B1|Baseline|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
377427|NCT00684996|P1|Participant Flow|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
377428|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity un til the recommended phase II dose (RPTD) of bevacizumab is determined.
377429|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
377430|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
377431|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
377432|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
377433|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
377434|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
377435|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
377436|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
377437|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
377438|NCT00684996|E1|Reported Event|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
377439|NCT00684983|B3|Baseline|Total|Total of all reporting groups
377440|NCT00684983|B2|Baseline|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
377441|NCT00684983|B1|Baseline|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
377442|NCT00684983|P2|Participant Flow|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
377443|NCT00684983|P1|Participant Flow|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
377445|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
377446|NCT00684983|E2|Reported Event|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
377447|NCT00684983|E1|Reported Event|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
377448|NCT00684814|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours.
377449|NCT00684814|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
377450|NCT00684814|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
377451|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
377452|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
377453|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
377454|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
377455|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
377456|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
377457|NCT00684814|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
377458|NCT00684814|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
377459|NCT00684762|B1|Baseline|Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
377460|NCT00684762|P2|Participant Flow|Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
377461|NCT00684762|P1|Participant Flow|Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
377462|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
377463|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377464|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
377465|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377466|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
377467|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
377468|NCT00684762|E2|Reported Event|Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
377469|NCT00684762|E1|Reported Event|Cilostazol 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
377470|NCT00684749|B1|Baseline|Total Population|All surgical patients
377471|NCT00684749|P1|Participant Flow|Total Population|All surgical patients
377472|NCT00684749|O1|Outcome|Total Population|All surgical patients
377473|NCT00684749|E1|Reported Event|Total Population|All surgical patients
377474|NCT00684723|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377475|NCT00684723|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377476|NCT00684723|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377477|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377478|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377479|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377480|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377481|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377482|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377483|NCT00684723|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
377484|NCT00684723|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
377485|NCT00684671|B4|Baseline|Total|Total of all reporting groups
377486|NCT00684671|B3|Baseline|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377487|NCT00684671|B2|Baseline|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377488|NCT00684671|B1|Baseline|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377489|NCT00684671|P3|Participant Flow|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377490|NCT00684671|P2|Participant Flow|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377491|NCT00684671|P1|Participant Flow|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377492|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377493|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377494|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377539|NCT00684593|B1|Baseline|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377498|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377499|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377500|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377501|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377502|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377503|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377504|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377505|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377506|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377507|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377508|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377509|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377510|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377511|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377512|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377513|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377514|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377515|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377516|NCT00684671|E3|Reported Event|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
377517|NCT00684671|E2|Reported Event|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
377518|NCT00684671|E1|Reported Event|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
377519|NCT00684645|B1|Baseline|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377520|NCT00684645|P1|Participant Flow|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377521|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377522|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377523|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377524|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377525|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377526|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377527|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377528|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377529|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377530|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377531|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377532|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377533|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377534|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377535|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377536|NCT00684645|E1|Reported Event|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
377537|NCT00684593|B3|Baseline|Total|Total of all reporting groups
377540|NCT00684593|P2|Participant Flow|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
377541|NCT00684593|P1|Participant Flow|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377542|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377543|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377544|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377545|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377546|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
377547|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377548|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
377549|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377550|NCT00684593|E2|Reported Event|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
377551|NCT00684593|E1|Reported Event|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
377552|NCT00684567|B1|Baseline|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377553|NCT00684567|P1|Participant Flow|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377554|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377555|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377556|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377557|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377558|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
377559|NCT00684567|E1|Reported Event|Radiotherapy/Temozolomide|
377560|NCT00684554|B3|Baseline|Total|Total of all reporting groups
377561|NCT00684554|B2|Baseline|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
377562|NCT00684554|B1|Baseline|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
377563|NCT00684554|P2|Participant Flow|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
377564|NCT00684554|P1|Participant Flow|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
377565|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
377566|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
377567|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
377568|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
377569|NCT00684554|E2|Reported Event|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
377570|NCT00684554|E1|Reported Event|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
377571|NCT00684541|B3|Baseline|Total|Total of all reporting groups
377572|NCT00684541|B2|Baseline|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
377573|NCT00684541|B1|Baseline|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
377574|NCT00684541|P2|Participant Flow|Interpretation Control Condition (ICC)|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
377597|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377598|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377599|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377600|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377575|NCT00684541|P1|Participant Flow|Interpretation Modification Program (IMP)|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
377576|NCT00684541|O2|Outcome|Interpretation Control Condition|"The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.~Interpretation Control Condition: Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation."
377577|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
377578|NCT00684541|O2|Outcome|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
377579|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
377580|NCT00684541|E2|Reported Event|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
377581|NCT00684541|E1|Reported Event|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
377582|NCT00684515|B4|Baseline|Total|Total of all reporting groups
377583|NCT00684515|B3|Baseline|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377584|NCT00684515|B2|Baseline|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377585|NCT00684515|B1|Baseline|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377586|NCT00684515|P3|Participant Flow|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377587|NCT00684515|P2|Participant Flow|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377588|NCT00684515|P1|Participant Flow|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377589|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377590|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377591|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377592|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377593|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377594|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377595|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377596|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377601|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377602|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377603|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377604|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377605|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377606|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377607|NCT00684515|E3|Reported Event|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
377608|NCT00684515|E2|Reported Event|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
377609|NCT00684515|E1|Reported Event|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
377610|NCT00684424|B1|Baseline|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377611|NCT00684424|P1|Participant Flow|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377612|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377613|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377614|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377615|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377616|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377617|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377618|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377619|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377620|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377621|NCT00684424|O1|Outcome|Pregabalin|
377622|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377623|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377624|NCT00684424|E1|Reported Event|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
377625|NCT00684411|B1|Baseline|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377626|NCT00684411|P1|Participant Flow|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377627|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377628|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377629|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377630|NCT00684411|E1|Reported Event|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
377631|NCT00684320|B3|Baseline|Total|Total of all reporting groups
377632|NCT00684320|B2|Baseline|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
377633|NCT00684320|B1|Baseline|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
377634|NCT00684320|P2|Participant Flow|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
377635|NCT00684320|P1|Participant Flow|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
377636|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
377637|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
377638|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
377639|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
377640|NCT00684320|E2|Reported Event|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
377724|NCT00684242|P1|Participant Flow|Lenalidomide|10 mg by mouth daily
377725|NCT00684242|O1|Outcome|Lenalidomide|10 mg by mouth daily
377726|NCT00684242|E1|Reported Event|Lenalidomide|10 mg by mouth daily
377727|NCT00684203|B7|Baseline|Total|Total of all reporting groups
377641|NCT00684320|E1|Reported Event|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
377642|NCT00684307|B6|Baseline|Total|Total of all reporting groups
377643|NCT00684307|B5|Baseline|VKA INR 2-3|
377644|NCT00684307|B4|Baseline|200 mg bd|AZD0837 200 mg bd
377645|NCT00684307|B3|Baseline|450 mg od|AZD0837 450 mg od
377646|NCT00684307|B2|Baseline|300 mg od|AZD0837 300 mg od
377647|NCT00684307|B1|Baseline|150 mg od|AZD0837 150 mg od
377648|NCT00684307|P5|Participant Flow|VKA INR 2-3|
377649|NCT00684307|P4|Participant Flow|200 mg bd|AZD0837 200 mg bd
377650|NCT00684307|P3|Participant Flow|450 mg od|AZD0837 450 mg od
377651|NCT00684307|P2|Participant Flow|300 mg od|AZD0837 300 mg od
377652|NCT00684307|P1|Participant Flow|150 mg od|AZD0837 150 mg od
377653|NCT00684307|O5|Outcome|VKA INR 2-3|
377654|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377655|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377656|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377657|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377658|NCT00684307|O5|Outcome|VKA INR 2-3|
377659|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377660|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377661|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377662|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377663|NCT00684307|O5|Outcome|VKA INR 2-3|
377664|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377665|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377666|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377667|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377668|NCT00684307|O5|Outcome|VKA INR 2-3|
377669|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377670|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377671|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377672|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377673|NCT00684307|O5|Outcome|VKA INR 2-3|
377674|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377675|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377676|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377677|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377678|NCT00684307|O5|Outcome|VKA INR 2-3|
377679|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377680|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377681|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377682|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377683|NCT00684307|O5|Outcome|VKA INR 2-3|
377684|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377685|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377686|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377687|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377688|NCT00684307|O5|Outcome|VKA INR 2-3|
377689|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377690|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377691|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377692|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377693|NCT00684307|O5|Outcome|VKA INR 2-3|
377694|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377695|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377696|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377697|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377698|NCT00684307|O5|Outcome|VKA INR 2-3|
377699|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377700|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377701|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377702|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377703|NCT00684307|O5|Outcome|VKA INR 2-3|
377704|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377705|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377706|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377707|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377708|NCT00684307|O5|Outcome|VKA INR 2-3|
377709|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
377710|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
377711|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
377712|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
377713|NCT00684307|E5|Reported Event|VKA INR 2-3|
377714|NCT00684307|E4|Reported Event|AZD0837 200 mg bd|
377715|NCT00684307|E3|Reported Event|AZD0837 450 mg od|
377716|NCT00684307|E2|Reported Event|AZD0837 300 mg od|
377717|NCT00684307|E1|Reported Event|AZD0837 150 mg od|
377718|NCT00684255|B1|Baseline|Systemic Sclerosis (SSc)|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
377719|NCT00684255|P1|Participant Flow|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
377720|NCT00684255|O2|Outcome|Systemic Sclerosis (SSc)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
377721|NCT00684255|O1|Outcome|Medically Refractory Systemic Lupus Erythematosus (SLE)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
377722|NCT00684255|E1|Reported Event|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
377723|NCT00684242|B1|Baseline|Lenalidomide|10 mg by mouth daily
377728|NCT00684203|B6|Baseline|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377729|NCT00684203|B5|Baseline|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377730|NCT00684203|B4|Baseline|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
377731|NCT00684203|B3|Baseline|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377732|NCT00684203|B2|Baseline|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377733|NCT00684203|B1|Baseline|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377734|NCT00684203|P6|Participant Flow|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377735|NCT00684203|P5|Participant Flow|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377736|NCT00684203|P4|Participant Flow|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
377737|NCT00684203|P3|Participant Flow|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377738|NCT00684203|P2|Participant Flow|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377739|NCT00684203|P1|Participant Flow|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377740|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377741|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377742|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377743|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377744|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377745|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377746|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377747|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377748|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377749|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377750|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377751|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377752|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377753|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377754|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377755|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377835|NCT00684073|B1|Baseline|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377756|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377757|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377758|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377759|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377760|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377761|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377762|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377763|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377764|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377765|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377766|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377767|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377768|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377769|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377770|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377771|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377772|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377773|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377774|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377775|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377776|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377777|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377778|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377779|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377780|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377781|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377782|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377783|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377784|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377834|NCT00684138|E1|Reported Event|ACRYSOF® ReSTOR® +3.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only
377785|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377786|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377787|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377788|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377789|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377790|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377791|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377792|NCT00684203|E5|Reported Event|Placebo/Placebo|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377793|NCT00684203|E4|Reported Event|Vorapaxar 40 mg/2.5 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377794|NCT00684203|E3|Reported Event|Vorapaxar 40 mg/1 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377795|NCT00684203|E2|Reported Event|Vorapaxar 20 mg/2.5 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377796|NCT00684203|E1|Reported Event|Vorapaxar 20 mg/1 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
377797|NCT00684177|B3|Baseline|Total|Total of all reporting groups
377798|NCT00684177|B2|Baseline|Placebo|Matching placebo
377799|NCT00684177|B1|Baseline|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377800|NCT00684177|P2|Participant Flow|Placebo|Matching placebo
377801|NCT00684177|P1|Participant Flow|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377802|NCT00684177|O2|Outcome|Placebo|Matching placebo
377803|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377804|NCT00684177|O2|Outcome|Placebo|Matching placebo
377805|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377806|NCT00684177|O2|Outcome|Placebo|Matching placebo
377807|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377808|NCT00684177|O2|Outcome|Placebo|Matching placebo
377809|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377810|NCT00684177|O2|Outcome|Placebo|Matching placebo
377811|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377812|NCT00684177|O2|Outcome|Placebo|Matching placebo
377813|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377814|NCT00684177|E2|Reported Event|Placebo|Matching placebo
377815|NCT00684177|E1|Reported Event|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
377816|NCT00684138|B3|Baseline|Total|Total of all reporting groups
377817|NCT00684138|B2|Baseline|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377818|NCT00684138|B1|Baseline|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377819|NCT00684138|P2|Participant Flow|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377820|NCT00684138|P1|Participant Flow|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377821|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377822|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377823|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377824|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377825|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377826|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377827|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377828|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377829|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
377830|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
377831|NCT00684138|E4|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
377832|NCT00684138|E3|Reported Event|ACRYSOF® ReSTOR® +3.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only
377833|NCT00684138|E2|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only
377836|NCT00684073|P1|Participant Flow|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377837|NCT00684073|O5|Outcome|Day 5 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377838|NCT00684073|O4|Outcome|Day 4 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377839|NCT00684073|O3|Outcome|Day 3 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377840|NCT00684073|O2|Outcome|Day 2 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377841|NCT00684073|O1|Outcome|Day 1 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377842|NCT00684073|E1|Reported Event|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
377843|NCT00684060|B3|Baseline|Total|Total of all reporting groups
377844|NCT00684060|B2|Baseline|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377845|NCT00684060|B1|Baseline|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377846|NCT00684060|P2|Participant Flow|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377847|NCT00684060|P1|Participant Flow|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377848|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377849|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377850|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377851|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377852|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377853|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377854|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377855|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377856|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377857|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377858|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377859|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377860|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377861|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377862|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377863|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377864|NCT00684060|E2|Reported Event|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
377865|NCT00684060|E1|Reported Event|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
377866|NCT00684047|B4|Baseline|Total|Total of all reporting groups
377867|NCT00684047|B3|Baseline|Manual Compression Primary Part (II)|Subjects treated with manual compression were analyzed.
377868|NCT00684047|B2|Baseline|FS Grifols Primary Part (II)|Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377869|NCT00684047|B1|Baseline|FS Grifols Preliminary Part (I)|Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377870|NCT00684047|P3|Participant Flow|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
377871|NCT00684047|P2|Participant Flow|FS Grifols Primary Part (II)|FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377872|NCT00684047|P1|Participant Flow|FS Grifols Preliminary Part (I)|FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377873|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
377874|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377875|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
377876|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifol was applied in subjects. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377877|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
377878|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
377879|NCT00684047|E2|Reported Event|Manual Compression Primary Part (II)|The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
377995|NCT00683826|B2|Baseline|Leucine 8 Grams|Initial intervention.
377880|NCT00684047|E1|Reported Event|FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]|"The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.~The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses."
377881|NCT00684021|B5|Baseline|Total|Total of all reporting groups
377882|NCT00684021|B4|Baseline|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377883|NCT00684021|B3|Baseline|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377884|NCT00684021|B2|Baseline|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377885|NCT00684021|B1|Baseline|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377886|NCT00684021|P4|Participant Flow|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377887|NCT00684021|P3|Participant Flow|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377888|NCT00684021|P2|Participant Flow|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377889|NCT00684021|P1|Participant Flow|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377890|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377891|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377892|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377893|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377894|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377895|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377896|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377897|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377898|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377899|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377900|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377901|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377902|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377903|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377904|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377905|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377906|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377907|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377908|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377909|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377910|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377911|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377912|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377913|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377914|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377915|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377916|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377917|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377918|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377919|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377920|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377921|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377922|NCT00684021|E4|Reported Event|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
377923|NCT00684021|E3|Reported Event|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
377924|NCT00684021|E2|Reported Event|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
377925|NCT00684021|E1|Reported Event|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
377926|NCT00683930|B4|Baseline|Total|Total of all reporting groups
377927|NCT00683930|B3|Baseline|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
377928|NCT00683930|B2|Baseline|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
377929|NCT00683930|B1|Baseline|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377930|NCT00683930|P3|Participant Flow|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
377931|NCT00683930|P2|Participant Flow|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
377932|NCT00683930|P1|Participant Flow|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377933|NCT00683930|O4|Outcome|Mycophenolate Mofetil 3 g/Day|MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
377934|NCT00683930|O3|Outcome|Mycophenolate Mofetil 2 g/Day|MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
377935|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
377936|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377937|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
377938|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377939|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
377940|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377941|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
377942|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377943|NCT00683930|E3|Reported Event|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
377944|NCT00683930|E2|Reported Event|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
377945|NCT00683930|E1|Reported Event|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
377946|NCT00683917|B4|Baseline|Total|Total of all reporting groups
377947|NCT00683917|B3|Baseline|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
377948|NCT00683917|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
377949|NCT00683917|B1|Baseline|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
377950|NCT00683917|P1|Participant Flow|Proellex All Groups|Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available
377951|NCT00683917|O3|Outcome|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
377952|NCT00683917|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
377953|NCT00683917|O1|Outcome|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
377954|NCT00683917|E3|Reported Event|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
377955|NCT00683917|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
377956|NCT00683917|E1|Reported Event|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
377957|NCT00683904|B3|Baseline|Total|Total of all reporting groups
377958|NCT00683904|B2|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377959|NCT00683904|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377960|NCT00683904|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.
377961|NCT00683904|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377962|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377963|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377964|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377965|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377996|NCT00683826|B1|Baseline|Leucine 4 Grams|Initial intervention.
378181|NCT00683618|E3|Reported Event|Atorvastatin 10mg|Taken orally once daily
377966|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377967|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377968|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377969|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377970|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377971|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377972|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377973|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377974|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377975|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377976|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377977|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377978|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377979|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377980|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377981|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377982|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377983|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377984|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377985|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377986|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377987|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
377988|NCT00683904|O1|Outcome|All Treated|All subjects who received at least 1 dose of either ixabepilone or carboplatin
377989|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377990|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377991|NCT00683904|E2|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377992|NCT00683904|E1|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
377993|NCT00683826|B4|Baseline|Total|Total of all reporting groups
377994|NCT00683826|B3|Baseline|Leucine 0 Grams-control|Initial intervention.
377997|NCT00683826|P1|Participant Flow|All Study Participants|This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.
377998|NCT00683826|O3|Outcome|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
377999|NCT00683826|O2|Outcome|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
378000|NCT00683826|O1|Outcome|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
378001|NCT00683826|E3|Reported Event|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
378002|NCT00683826|E2|Reported Event|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
378003|NCT00683826|E1|Reported Event|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
378004|NCT00683800|B3|Baseline|Total|Total of all reporting groups
378005|NCT00683800|B2|Baseline|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378006|NCT00683800|B1|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378007|NCT00683800|P2|Participant Flow|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378008|NCT00683800|P1|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378009|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378010|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378011|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378012|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378013|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378014|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378015|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378016|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378017|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378018|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378019|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378020|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378021|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378022|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378023|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378024|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378025|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378026|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378027|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378028|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378029|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378030|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378031|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378032|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378033|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378034|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378035|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378036|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378037|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378038|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378039|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378040|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378041|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378042|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378043|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378044|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378045|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378046|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378047|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378048|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378049|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378050|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378051|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378052|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378053|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378054|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378055|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378056|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378057|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378058|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378059|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378060|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378061|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378062|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378063|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378064|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378065|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378066|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378067|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378068|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378069|NCT00683800|E2|Reported Event|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
378070|NCT00683800|E1|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
378071|NCT00683787|B4|Baseline|Total|Total of all reporting groups
378072|NCT00683787|B3|Baseline|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378073|NCT00683787|B2|Baseline|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378074|NCT00683787|B1|Baseline|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378075|NCT00683787|P3|Participant Flow|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378076|NCT00683787|P2|Participant Flow|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378077|NCT00683787|P1|Participant Flow|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378078|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378079|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378080|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378081|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378082|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378083|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378084|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378085|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378086|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378087|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378145|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
378146|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
378088|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378089|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378090|NCT00683787|E3|Reported Event|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378091|NCT00683787|E2|Reported Event|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
378092|NCT00683787|E1|Reported Event|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
378093|NCT00683774|B3|Baseline|Total|Total of all reporting groups
378094|NCT00683774|B2|Baseline|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378095|NCT00683774|B1|Baseline|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378096|NCT00683774|P2|Participant Flow|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378097|NCT00683774|P1|Participant Flow|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378098|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378099|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378100|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378101|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378102|NCT00683774|E2|Reported Event|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378103|NCT00683774|E1|Reported Event|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
378104|NCT00683696|B3|Baseline|Total|Total of all reporting groups
378105|NCT00683696|B2|Baseline|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
378106|NCT00683696|B1|Baseline|CRT=ON|Cardiac Resynchronization Therapy activated.
378107|NCT00683696|P2|Participant Flow|CRT=OFF|"Cardiac Resynchronization Therapy deactivated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF."
378108|NCT00683696|P1|Participant Flow|CRT=ON|"Cardiac Resynchronization Therapy activated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON."
378109|NCT00683696|O1|Outcome|Subjects That Underwent an Implant Attempt|
378110|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
378111|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
378112|NCT00683696|E2|Reported Event|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
378113|NCT00683696|E1|Reported Event|CRT=ON|Cardiac Resynchronization Therapy activated.
378114|NCT00683657|B3|Baseline|Total|Total of all reporting groups
378115|NCT00683657|B2|Baseline|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378116|NCT00683657|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378117|NCT00683657|P2|Participant Flow|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378118|NCT00683657|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378119|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378120|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378121|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378122|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378123|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378124|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378125|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378126|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378127|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
378128|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
378129|NCT00683657|E2|Reported Event|SAXA 5MG + MET|
378130|NCT00683657|E1|Reported Event|PLACEBO + MET|
378131|NCT00683618|B4|Baseline|Total|Total of all reporting groups
378132|NCT00683618|B3|Baseline|Atorvastatin 10mg|Taken orally once daily
378133|NCT00683618|B2|Baseline|Rosuvastatin 10mg|Taken orally once daily
378134|NCT00683618|B1|Baseline|Rosuvastatin 5mg|Taken orally once daily
378135|NCT00683618|P3|Participant Flow|Atorvastatin 10mg|Taken orally once daily
378136|NCT00683618|P2|Participant Flow|Rosuvastatin 10mg|Taken orally once daily
378137|NCT00683618|P1|Participant Flow|Rosuvastatin 5mg|Taken orally once daily
378138|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
378139|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
378140|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
378141|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
378142|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
378143|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
378144|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
378182|NCT00683618|E2|Reported Event|Rosuvastatin 10mg|Taken orally once daily
378183|NCT00683618|E1|Reported Event|Rosuvastatin 5mg|Taken orally once daily
378184|NCT00683592|B3|Baseline|Total|Total of all reporting groups
378185|NCT00683592|B2|Baseline|Placebo (ITT Population)|placebo to match vilazodone
378186|NCT00683592|B1|Baseline|Vilazodone (ITT Population)|Vilazodone, 40 mg
378187|NCT00683592|P2|Participant Flow|Placebo|Placebo to match vilazodone. Two tablets per day.
378188|NCT00683592|P1|Participant Flow|Vilazodone|Vilazodone titrated to 40mg. Two tablets per day.
378189|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378190|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378191|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378192|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378193|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378194|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378195|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378196|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378197|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378198|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378199|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
378200|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
378201|NCT00683592|E2|Reported Event|Placebo (Safety Population)|placebo to match vilazodone
378202|NCT00683592|E1|Reported Event|Vilazodone (Safety Population)|Vilazodone, 40mg
378203|NCT00683475|B3|Baseline|Total|Total of all reporting groups
378204|NCT00683475|B2|Baseline|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378205|NCT00683475|B1|Baseline|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378206|NCT00683475|P2|Participant Flow|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378207|NCT00683475|P1|Participant Flow|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378208|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378209|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378210|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378211|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378212|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378213|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378214|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378215|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378216|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378326|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378217|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378218|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378219|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378220|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378221|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378222|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378223|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378224|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378225|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378226|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378227|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378228|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378229|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378230|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378231|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378232|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378233|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378234|NCT00683475|E2|Reported Event|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378235|NCT00683475|E1|Reported Event|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
378236|NCT00683449|B6|Baseline|Total|Total of all reporting groups
378237|NCT00683449|B5|Baseline|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
378238|NCT00683449|B4|Baseline|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
378239|NCT00683449|B3|Baseline|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
378240|NCT00683449|B2|Baseline|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
378241|NCT00683449|B1|Baseline|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
378242|NCT00683449|P5|Participant Flow|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
378243|NCT00683449|P4|Participant Flow|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
378244|NCT00683449|P3|Participant Flow|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
378245|NCT00683449|P2|Participant Flow|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
378246|NCT00683449|P1|Participant Flow|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
378247|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
378248|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
378249|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
378292|NCT00683163|B1|Baseline|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
378250|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
378251|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
378252|NCT00683449|O5|Outcome|1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes|One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
378253|NCT00683449|O4|Outcome|1,000-1,080 μg MN-221 Given i.v. for 15 Minutes|The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
378254|NCT00683449|O3|Outcome|450 μg MN-221 Given i.v.|The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
378255|NCT00683449|O2|Outcome|Placebo Administered Intravenously|Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
378256|NCT00683449|O1|Outcome|MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg)|The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
378257|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
378258|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
378259|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
378260|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
378261|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
378262|NCT00683449|E5|Reported Event|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
378263|NCT00683449|E4|Reported Event|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
378291|NCT00683163|B2|Baseline|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
381233|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
378264|NCT00683449|E3|Reported Event|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
378265|NCT00683449|E2|Reported Event|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
378266|NCT00683449|E1|Reported Event|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
378267|NCT00683410|B1|Baseline|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
378268|NCT00683410|P1|Participant Flow|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
378269|NCT00683410|O1|Outcome|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
378270|NCT00683410|E1|Reported Event|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
378271|NCT00683384|B1|Baseline|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
378272|NCT00683384|P1|Participant Flow|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
378273|NCT00683384|O1|Outcome|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
378274|NCT00683384|E1|Reported Event|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
378275|NCT00683332|B1|Baseline|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
378276|NCT00683332|P1|Participant Flow|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
378277|NCT00683332|O1|Outcome|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
378278|NCT00683332|E1|Reported Event|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
378279|NCT00683293|B3|Baseline|Total|Total of all reporting groups
378280|NCT00683293|B2|Baseline|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
378281|NCT00683293|B1|Baseline|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
378282|NCT00683293|P2|Participant Flow|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
378283|NCT00683293|P1|Participant Flow|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
378284|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
378285|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
378286|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
378287|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
378288|NCT00683293|E2|Reported Event|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
378289|NCT00683293|E1|Reported Event|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
378290|NCT00683163|B3|Baseline|Total|Total of all reporting groups
378293|NCT00683163|P2|Participant Flow|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
378294|NCT00683163|P1|Participant Flow|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily parathyroid hormone (PTH) 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
378295|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
378296|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
378297|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
378298|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
378299|NCT00683163|E2|Reported Event|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
378300|NCT00683163|E1|Reported Event|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
378301|NCT00683085|B1|Baseline|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
378302|NCT00683085|P1|Participant Flow|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
378303|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
378304|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
378305|NCT00683085|E1|Reported Event|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
378306|NCT00683046|B1|Baseline|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
378307|NCT00683046|P1|Participant Flow|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
378308|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
378309|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
378310|NCT00683046|E1|Reported Event|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
378311|NCT00683020|B3|Baseline|Total|Total of all reporting groups
378312|NCT00683020|B2|Baseline|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378313|NCT00683020|B1|Baseline|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378314|NCT00683020|P2|Participant Flow|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378315|NCT00683020|P1|Participant Flow|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378316|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378317|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378318|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378319|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378320|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378321|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378322|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378323|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378324|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378325|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378327|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378328|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378329|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378330|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378331|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378332|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378333|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378334|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378335|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378336|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378337|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378338|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378339|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378340|NCT00683020|E2|Reported Event|WAIT LIST Control|WAIT LIST Control: six month Wait List.
378341|NCT00683020|E1|Reported Event|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
378342|NCT00682890|B3|Baseline|Total|Total of all reporting groups
378343|NCT00682890|B2|Baseline|Metformin|metformin 2000 mg and birth control pill daily
378344|NCT00682890|B1|Baseline|Placebo|Placebo tablet and birth control pill daily
378345|NCT00682890|P2|Participant Flow|Metformin|metformin 2000 mg and birth control pill daily
378346|NCT00682890|P1|Participant Flow|Placebo|Placebo tablet and birth control pill daily
378347|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
378348|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
378349|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
378350|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
378351|NCT00682890|E2|Reported Event|Metformin|metformin 2000 mg and birth control pill daily
378352|NCT00682890|E1|Reported Event|Placebo|Placebo tablet and birth control pill daily
378353|NCT00682851|B3|Baseline|Total|Total of all reporting groups
378354|NCT00682851|B2|Baseline|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378355|NCT00682851|B1|Baseline|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378356|NCT00682851|P2|Participant Flow|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378357|NCT00682851|P1|Participant Flow|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378358|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378359|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378360|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378361|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378362|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378363|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378364|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378365|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378366|NCT00682851|E2|Reported Event|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
378367|NCT00682851|E1|Reported Event|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
378368|NCT00682838|B5|Baseline|Total|Total of all reporting groups
378369|NCT00682838|B4|Baseline|Usual Care|Usual care- control group
378370|NCT00682838|B3|Baseline|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
378371|NCT00682838|B2|Baseline|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
378372|NCT00682838|B1|Baseline|Self-management|"Active Intervention~Self-management: Self-management"
378373|NCT00682838|P4|Participant Flow|Usual Care|Usual care- control group
378374|NCT00682838|P3|Participant Flow|SM + TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care~Combination of both SM + TC intervention"
378795|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378375|NCT00682838|P2|Participant Flow|Telemonitored Care (TC)|"Active Comparator~Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol"
378376|NCT00682838|P1|Participant Flow|Self-Management (SM)|"Active Intervention~Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective"
378377|NCT00682838|O4|Outcome|Usual Care|Usual care- control group
378378|NCT00682838|O3|Outcome|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
378379|NCT00682838|O2|Outcome|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
378380|NCT00682838|O1|Outcome|Self-management|"Active Intervention~Self-management: Self-management"
378381|NCT00682838|E4|Reported Event|Usual Care|Control Group
378382|NCT00682838|E3|Reported Event|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
378383|NCT00682838|E2|Reported Event|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
378384|NCT00682838|E1|Reported Event|Self-management|"Active Intervention~Self-management: Self-management"
378385|NCT00682786|B3|Baseline|Total|Total of all reporting groups
378386|NCT00682786|B2|Baseline|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378387|NCT00682786|B1|Baseline|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378388|NCT00682786|P2|Participant Flow|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378389|NCT00682786|P1|Participant Flow|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378390|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378391|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378392|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378393|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378394|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378395|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378396|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378397|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378398|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378399|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378400|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378401|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378402|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378403|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378404|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378405|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378796|NCT00681291|E2|Reported Event|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378406|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378407|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378408|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378409|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378410|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378411|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378412|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378413|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378414|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378415|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378416|NCT00682786|E2|Reported Event|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378417|NCT00682786|E1|Reported Event|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
378418|NCT00682734|B4|Baseline|Total|Total of all reporting groups
378419|NCT00682734|B3|Baseline|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
378420|NCT00682734|B2|Baseline|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
378421|NCT00682734|B1|Baseline|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
378422|NCT00682734|P3|Participant Flow|Metoclopramide 40 mg Intravenous|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
378423|NCT00682734|P2|Participant Flow|Metoclopramide 20 mg Intravenous|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
378424|NCT00682734|P1|Participant Flow|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous
378425|NCT00682734|O3|Outcome|Metoclopramide 40 mg|Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
378426|NCT00682734|O2|Outcome|Metoclopramide 20 mg|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
378427|NCT00682734|O1|Outcome|Metoclopramide 10 mg Intravenous|Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
378428|NCT00682734|E3|Reported Event|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
378429|NCT00682734|E2|Reported Event|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
378430|NCT00682734|E1|Reported Event|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
378431|NCT00682643|B3|Baseline|Total|Total of all reporting groups
378432|NCT00682643|B2|Baseline|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378433|NCT00682643|B1|Baseline|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378434|NCT00682643|P2|Participant Flow|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378435|NCT00682643|P1|Participant Flow|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378436|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378437|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378438|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378439|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378440|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378441|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378442|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378443|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378444|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378445|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378446|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378447|NCT00682643|O1|Outcome|Placebo|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
378448|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378449|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378450|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378451|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378452|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378453|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378454|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378455|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378456|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378457|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378458|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378459|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378460|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378461|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378462|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378463|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378464|NCT00682643|E2|Reported Event|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
378465|NCT00682643|E1|Reported Event|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
378466|NCT00682565|B4|Baseline|Total|Total of all reporting groups
378467|NCT00682565|B3|Baseline|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378468|NCT00682565|B2|Baseline|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378797|NCT00681291|E1|Reported Event|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378469|NCT00682565|B1|Baseline|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378470|NCT00682565|P3|Participant Flow|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378471|NCT00682565|P2|Participant Flow|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378472|NCT00682565|P1|Participant Flow|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378473|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378474|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378475|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378476|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378477|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378478|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378479|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378480|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378481|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378482|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378483|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378484|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378485|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378486|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378487|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378488|NCT00682565|E4|Reported Event|Total|All Patients
378489|NCT00682565|E3|Reported Event|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378490|NCT00682565|E2|Reported Event|Cohort 2 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378491|NCT00682565|E1|Reported Event|Cohort 1 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
378492|NCT00682539|B4|Baseline|Total|Total of all reporting groups
378493|NCT00682539|B3|Baseline|Lucentis|After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
378494|NCT00682539|B2|Baseline|Triamciolone|Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
378495|NCT00682539|B1|Baseline|Avastin|After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
378496|NCT00682539|P3|Participant Flow|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
378497|NCT00682539|P2|Participant Flow|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
378498|NCT00682539|P1|Participant Flow|Avastin|15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
378499|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
378500|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
378501|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
378502|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
378503|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
378504|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
378505|NCT00682539|E3|Reported Event|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
378506|NCT00682539|E2|Reported Event|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
381234|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
378507|NCT00682539|E1|Reported Event|Avastin|Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
378508|NCT00682461|B3|Baseline|Total|Total of all reporting groups
378509|NCT00682461|B2|Baseline|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378510|NCT00682461|B1|Baseline|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378511|NCT00682461|P2|Participant Flow|Nicotine Lozenge (2.0 mg)|Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378512|NCT00682461|P1|Participant Flow|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378513|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378514|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378515|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378516|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378517|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378518|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378519|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378520|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378521|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
378522|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
378523|NCT00682461|E2|Reported Event|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
378524|NCT00682461|E1|Reported Event|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
378525|NCT00682357|B4|Baseline|Total|Total of all reporting groups
378526|NCT00682357|B3|Baseline|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378527|NCT00682357|B2|Baseline|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378528|NCT00682357|B1|Baseline|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378529|NCT00682357|P3|Participant Flow|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378530|NCT00682357|P2|Participant Flow|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378531|NCT00682357|P1|Participant Flow|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378532|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378533|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378534|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378535|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378536|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378537|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378538|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378539|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378540|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378541|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378542|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378543|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378544|NCT00682357|E3|Reported Event|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
378545|NCT00682357|E2|Reported Event|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
378546|NCT00682357|E1|Reported Event|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
378547|NCT00681889|B1|Baseline|Treatment Arm|"10 Patients will receive treatment (Ranibizumab)~Ranibizumab : 10 Patients will receive treatment (Ranibizumab)"
378548|NCT00681889|P1|Participant Flow|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
378549|NCT00681889|O1|Outcome|Treatment Arm|"9 Patients will receive treatment (Ranibizumab)~Ranibizumab : 9 Patients will receive treatment (Ranibizumab)"
378550|NCT00681889|E1|Reported Event|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
378551|NCT00681863|B1|Baseline|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378552|NCT00681863|P1|Participant Flow|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378553|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378554|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378555|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378556|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378557|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378558|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378559|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378560|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378561|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378562|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378563|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378564|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378565|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378566|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378567|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378568|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378569|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378570|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378571|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378572|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378573|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378625|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
381235|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
378574|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378575|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378576|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378577|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378578|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378579|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378580|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378581|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378582|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378583|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378584|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378585|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378586|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378587|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378588|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378589|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378590|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378591|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378592|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378593|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378594|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378595|NCT00681863|E1|Reported Event|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
378596|NCT00681824|B4|Baseline|Total|Total of all reporting groups
378626|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
378597|NCT00681824|B3|Baseline|FS VH S/D 500 S-apr (Non Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
378598|NCT00681824|B2|Baseline|FS VH S/D 500 S-apr (Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
378599|NCT00681824|B1|Baseline|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378600|NCT00681824|P3|Participant Flow|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
378601|NCT00681824|P2|Participant Flow|Run-in Participants: FS VH S/D 500 S-apr|One initial
378602|NCT00681824|P1|Participant Flow|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378603|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378604|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378605|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378606|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378607|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378608|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378609|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378610|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378611|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378612|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378613|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
378614|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378615|NCT00681824|E2|Reported Event|FS VH S/D 500 S-apr|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
378616|NCT00681824|E1|Reported Event|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
378617|NCT00681811|B3|Baseline|Total|Total of all reporting groups
378618|NCT00681811|B2|Baseline|200 U/kg|Participants received 200 U/kg of HGT1111 IV infusion every other week.
378619|NCT00681811|B1|Baseline|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
378620|NCT00681811|P2|Participant Flow|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
378621|NCT00681811|P1|Participant Flow|100 U/kg HGT-1111|Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
378622|NCT00681811|O2|Outcome|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
378623|NCT00681811|O1|Outcome|100 U/kg HGT-1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
378624|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
378627|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
378628|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
378629|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
378630|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
378631|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
378632|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
378633|NCT00681811|O5|Outcome|100 U/kg- HGT-1111(Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
378634|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
378635|NCT00681811|O3|Outcome|100 U/kg- HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
378636|NCT00681811|O2|Outcome|200 U/Kg-HGT-1111(Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
378637|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
378638|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
378639|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
378640|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
378641|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
378642|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
378643|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
378644|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
378645|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
378646|NCT00681811|E2|Reported Event|200 U/kg HGT1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
378647|NCT00681811|E1|Reported Event|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
378648|NCT00681668|B1|Baseline|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
378649|NCT00681668|P1|Participant Flow|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
378650|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
378651|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
378652|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
378653|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
378654|NCT00681668|E1|Reported Event|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
378655|NCT00681629|B3|Baseline|Total|Total of all reporting groups
378656|NCT00681629|B2|Baseline|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378657|NCT00681629|B1|Baseline|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378658|NCT00681629|P2|Participant Flow|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378659|NCT00681629|P1|Participant Flow|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378660|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378661|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378662|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378663|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378664|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378665|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378666|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378667|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378668|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378669|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378670|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378671|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378672|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378673|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378674|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378675|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378676|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378677|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
379018|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
378678|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378679|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378680|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378681|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378682|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378683|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378684|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378685|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378686|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378687|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378688|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378689|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378690|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378691|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378692|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378759|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378826|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378693|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378694|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378695|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378696|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378697|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378698|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378699|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378700|NCT00681629|E2|Reported Event|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
378701|NCT00681629|E1|Reported Event|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
378702|NCT00681590|B3|Baseline|Total|Total of all reporting groups
378703|NCT00681590|B2|Baseline|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
378704|NCT00681590|B1|Baseline|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
378705|NCT00681590|P2|Participant Flow|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
378706|NCT00681590|P1|Participant Flow|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
378707|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
378708|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
378709|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
378710|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
378711|NCT00681590|E2|Reported Event|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
378712|NCT00681590|E1|Reported Event|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
378713|NCT00681564|B3|Baseline|Total|Total of all reporting groups
378714|NCT00681564|B2|Baseline|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378715|NCT00681564|B1|Baseline|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378716|NCT00681564|P2|Participant Flow|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378792|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378793|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378992|NCT00680745|B5|Baseline|Total|Total of all reporting groups
378717|NCT00681564|P1|Participant Flow|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378718|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378719|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378720|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378721|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378722|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378723|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378724|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378725|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378726|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378727|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378728|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378729|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378730|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378731|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378732|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378733|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378734|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378735|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378736|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378737|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378738|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378739|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378740|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378741|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378742|NCT00681564|E2|Reported Event|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
378743|NCT00681564|E1|Reported Event|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
378744|NCT00681538|B3|Baseline|Total|Total of all reporting groups
378745|NCT00681538|B2|Baseline|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378746|NCT00681538|B1|Baseline|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378747|NCT00681538|P2|Participant Flow|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378748|NCT00681538|P1|Participant Flow|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378749|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378750|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378751|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378752|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378753|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378754|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378755|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378756|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378757|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378758|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378794|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378993|NCT00680745|B4|Baseline|Placebo + Glimepiride|Placebo comparator plus glimepiride
378760|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378761|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378762|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378763|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378764|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378765|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378766|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378767|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378768|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378769|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378770|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378771|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378772|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378773|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378774|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378775|NCT00681538|E2|Reported Event|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
378776|NCT00681538|E1|Reported Event|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
378777|NCT00681473|B1|Baseline|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378778|NCT00681473|P1|Participant Flow|Proton Radiation Therapy|Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378779|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378780|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378781|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378782|NCT00681473|E1|Reported Event|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
378783|NCT00681291|B3|Baseline|Total|Total of all reporting groups
378784|NCT00681291|B2|Baseline|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378785|NCT00681291|B1|Baseline|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378786|NCT00681291|P2|Participant Flow|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378787|NCT00681291|P1|Participant Flow|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378788|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378789|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
378790|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
378791|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
381236|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
378798|NCT00681265|B1|Baseline|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
378799|NCT00681265|P1|Participant Flow|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
378800|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
378801|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
378802|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
378803|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
378804|NCT00681265|E2|Reported Event|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
378805|NCT00681265|E1|Reported Event|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
378806|NCT00681187|B3|Baseline|Total|Total of all reporting groups
378807|NCT00681187|B2|Baseline|Group 2 HCP Then Self or Partner Administration|Administration by HCP then self or partner administration.
378808|NCT00681187|B1|Baseline|Group 1 Self or Partner First Then HCP Administration|Self or partner administration followed by HCP administration.
378809|NCT00681187|P2|Participant Flow|Group 2 HCP Then Self or Partner Administration|Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject’s home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
378810|NCT00681187|P1|Participant Flow|Group 1 Self or Partner First Then HCP Administration|Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject’s home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.
378811|NCT00681187|O1|Outcome|Overall Study Group|One HCP from each site who enrolled participants answered the questions
378812|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378813|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378814|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
378815|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
378816|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378817|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378818|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
378819|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
378820|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378821|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
378822|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
378823|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378824|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
378825|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
379151|NCT00680121|E1|Reported Event|Control Group|Placebo; identically matched to Benfotiamine capsules
378827|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
378828|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378829|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
378830|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378831|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
378832|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
378833|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378834|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
378835|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
378836|NCT00681187|O2|Outcome|Group 2 HCP Then Self or Partner Administration|Administration by HCP then Self or Partner Administration.
378837|NCT00681187|O1|Outcome|Group 1 Self or Partner First Then HCP Administration|Self or Partner Administration followed by HCP Administration.
378838|NCT00681187|E3|Reported Event|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
378839|NCT00681187|E2|Reported Event|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
378840|NCT00681187|E1|Reported Event|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
378841|NCT00681109|B4|Baseline|Total|Total of all reporting groups
378842|NCT00681109|B3|Baseline|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
378843|NCT00681109|B2|Baseline|Placebo|Artificial Tear Topical Ophthalmic Solution
378844|NCT00681109|B1|Baseline|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
378845|NCT00681109|P3|Participant Flow|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
378846|NCT00681109|P2|Participant Flow|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
378847|NCT00681109|P1|Participant Flow|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
378848|NCT00681109|O3|Outcome|Anakinra 5% Topical Ophthalmic Solution|The OSDI was assessed for patients taking Anakinra (KINERET) 5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
378849|NCT00681109|O2|Outcome|Artificial Tear Topical Ophthalmic Solution|The OSDI was assessed for patients taking placebo. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
378850|NCT00681109|O1|Outcome|Anakinra 2.5% Topical Ophthalmic Solution|In this study, the OSDI was assessed for patients taking Anakinra (KINERET) 2.5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
378851|NCT00681109|E3|Reported Event|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
378852|NCT00681109|E2|Reported Event|Placebo|Artificial Tear Topical Ophthalmic Solution
378853|NCT00681109|E1|Reported Event|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
378854|NCT00680953|B4|Baseline|Total|Total of all reporting groups
378855|NCT00680953|B3|Baseline|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378856|NCT00680953|B2|Baseline|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378857|NCT00680953|B1|Baseline|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378858|NCT00680953|P3|Participant Flow|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378859|NCT00680953|P2|Participant Flow|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378860|NCT00680953|P1|Participant Flow|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378861|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378862|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378863|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378864|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378865|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378866|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378867|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378868|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378869|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378870|NCT00680953|E3|Reported Event|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
378871|NCT00680953|E2|Reported Event|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378872|NCT00680953|E1|Reported Event|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
378873|NCT00680914|B3|Baseline|Total|Total of all reporting groups
378874|NCT00680914|B2|Baseline|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378875|NCT00680914|B1|Baseline|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378876|NCT00680914|P2|Participant Flow|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378877|NCT00680914|P1|Participant Flow|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378878|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378879|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378880|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378881|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378882|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378883|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378884|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378885|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378886|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378887|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378888|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378889|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378890|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378891|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378892|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378893|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378894|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378895|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378896|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378897|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378898|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378899|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378900|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378901|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378902|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378903|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378904|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378905|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378906|NCT00680914|E2|Reported Event|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378907|NCT00680914|E1|Reported Event|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
378908|NCT00680901|B3|Baseline|Total|Total of all reporting groups
378994|NCT00680745|B3|Baseline|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379152|NCT00680056|B3|Baseline|Total|Total of all reporting groups
378909|NCT00680901|B2|Baseline|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378910|NCT00680901|B1|Baseline|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378911|NCT00680901|P2|Participant Flow|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378912|NCT00680901|P1|Participant Flow|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378913|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378914|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378915|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378916|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378995|NCT00680745|B2|Baseline|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
378996|NCT00680745|B1|Baseline|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
378997|NCT00680745|P4|Participant Flow|Placebo + Glimepiride|Placebo comparator plus glimepiride
378998|NCT00680745|P3|Participant Flow|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
378999|NCT00680745|P2|Participant Flow|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
381237|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
378917|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378918|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378919|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378920|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378921|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378922|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378923|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378924|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
379000|NCT00680745|P1|Participant Flow|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379001|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
379002|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379003|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379004|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379005|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
378925|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378926|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378927|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378928|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378929|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378930|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378931|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378932|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
379006|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379007|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379008|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379009|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
379010|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379011|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
378933|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378934|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378935|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378936|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378937|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378938|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378939|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378940|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
379012|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379013|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
379014|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379015|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379016|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379017|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
378941|NCT00680901|E2|Reported Event|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
378942|NCT00680901|E1|Reported Event|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
378943|NCT00680862|B1|Baseline|Group 1|VA employees
378944|NCT00680862|P1|Participant Flow|Group 1|VA employees
378945|NCT00680862|O1|Outcome|Group 1|VA employees
378946|NCT00680862|E1|Reported Event|Group 1|VA employees
378947|NCT00680836|B3|Baseline|Total|Total of all reporting groups
378948|NCT00680836|B2|Baseline|Treatment|These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day
378949|NCT00680836|B1|Baseline|Placebo|These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day
378950|NCT00680836|P2|Participant Flow|Active Group|These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
378951|NCT00680836|P1|Participant Flow|Placebo Group|These patients have Irritable Bowel syndrome and are receiving the placebo twice a day
378952|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378953|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
378954|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378955|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
378956|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378957|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
378958|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378959|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
378960|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378961|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
378962|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378963|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
378964|NCT00680836|E2|Reported Event|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
378965|NCT00680836|E1|Reported Event|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
378966|NCT00680797|B5|Baseline|Total|Total of all reporting groups
378967|NCT00680797|B4|Baseline|-T -E|-Testosterone, -Estrogen
378968|NCT00680797|B3|Baseline|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
378969|NCT00680797|B2|Baseline|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
378970|NCT00680797|B1|Baseline|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
378971|NCT00680797|P4|Participant Flow|-T -E|-Testosterone, -Estrogen
378972|NCT00680797|P3|Participant Flow|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
378973|NCT00680797|P2|Participant Flow|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
378974|NCT00680797|P1|Participant Flow|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
378975|NCT00680797|O4|Outcome|-T -E|-Testosterone, -Estrogen
378976|NCT00680797|O3|Outcome|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
378977|NCT00680797|O2|Outcome|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
378978|NCT00680797|O1|Outcome|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
378979|NCT00680797|E4|Reported Event|-T -E|-Testosterone, -Estrogen
378980|NCT00680797|E3|Reported Event|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
378981|NCT00680797|E2|Reported Event|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
378982|NCT00680797|E1|Reported Event|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
378983|NCT00680771|B3|Baseline|Total|Total of all reporting groups
378984|NCT00680771|B2|Baseline|Good Sleepers|participants meetoing criteira for Good Sleepers
378985|NCT00680771|B1|Baseline|Primary Insomnia|patients meeting criteria for primary insomnia.
378986|NCT00680771|P2|Participant Flow|Good Sleepers|Subjects meeting criteira for Good Sleepers
378987|NCT00680771|P1|Participant Flow|Primary Insomnia|Subjects meeting criteria for primary insomnia.
378988|NCT00680771|O2|Outcome|Good Sleepers|participants meetoing criteira for Good Sleepers
378989|NCT00680771|O1|Outcome|Primary Insomnia|patients meeting criteria for primary insomnia.
378990|NCT00680771|E2|Reported Event|Good Sleepers|participants meetoing criteira for Good Sleepers
378991|NCT00680771|E1|Reported Event|Primary Insomnia|patients meeting criteria for primary insomnia.
379019|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379020|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379021|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
379022|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379023|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379024|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379025|NCT00680745|E4|Reported Event|Placebo + Glimepiride|Placebo comparator plus glimepiride
379026|NCT00680745|E3|Reported Event|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
379027|NCT00680745|E2|Reported Event|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
379028|NCT00680745|E1|Reported Event|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
379029|NCT00680706|B3|Baseline|Total|Total of all reporting groups
379030|NCT00680706|B2|Baseline|Control|Receives placebo
379031|NCT00680706|B1|Baseline|Thiamine|Receives thiamine
379032|NCT00680706|P2|Participant Flow|Control|Receives placebo
379033|NCT00680706|P1|Participant Flow|Thiamine|Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
379034|NCT00680706|O2|Outcome|Thiamine|
379035|NCT00680706|O1|Outcome|Control|Placebo
379036|NCT00680706|O2|Outcome|Thiamine|
379037|NCT00680706|O1|Outcome|Control|Placebo
379038|NCT00680706|E2|Reported Event|Control|Receives placebo
379039|NCT00680706|E1|Reported Event|Thiamine|Receives thiamine
379040|NCT00680628|B3|Baseline|Total|Total of all reporting groups
379041|NCT00680628|B2|Baseline|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379042|NCT00680628|B1|Baseline|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379043|NCT00680628|P2|Participant Flow|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379044|NCT00680628|P1|Participant Flow|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379045|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379046|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379047|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379048|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379049|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379050|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379051|NCT00680628|E2|Reported Event|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
379052|NCT00680628|E1|Reported Event|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
379053|NCT00680524|B1|Baseline|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
379054|NCT00680524|P1|Participant Flow|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
379055|NCT00680524|O1|Outcome|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
379056|NCT00680524|E1|Reported Event|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
379057|NCT00680459|B3|Baseline|Total|Total of all reporting groups
379058|NCT00680459|B2|Baseline|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379059|NCT00680459|B1|Baseline|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379060|NCT00680459|P2|Participant Flow|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379061|NCT00680459|P1|Participant Flow|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379062|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379063|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379064|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379065|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379066|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379067|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379068|NCT00680459|E2|Reported Event|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379069|NCT00680459|E1|Reported Event|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
379070|NCT00680407|B4|Baseline|Total|Total of all reporting groups
379071|NCT00680407|B3|Baseline|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379072|NCT00680407|B2|Baseline|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379073|NCT00680407|B1|Baseline|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379074|NCT00680407|P3|Participant Flow|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379075|NCT00680407|P2|Participant Flow|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379076|NCT00680407|P1|Participant Flow|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379077|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379078|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379079|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379080|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379081|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379082|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379083|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379084|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379085|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379086|NCT00680407|E3|Reported Event|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
379087|NCT00680407|E2|Reported Event|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379088|NCT00680407|E1|Reported Event|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
379150|NCT00680121|E2|Reported Event|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379089|NCT00680368|B1|Baseline|Physician Residents and Attending Physicians|includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient
379090|NCT00680368|P1|Participant Flow|Group 1|The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.
379091|NCT00680368|O1|Outcome|Attending Physicians|Results reported only for the 37 attending physicians in the study sample
379092|NCT00680368|O1|Outcome|Physician Residents|Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant
379093|NCT00680368|O1|Outcome|Physician Residents and Attending Physicians|Sample included 112, including 60 physician residents and 37 attending physicians
379094|NCT00680368|E1|Reported Event|Group 1|Sample included 75 resident physicians. No adverse events noted.
379095|NCT00680316|B3|Baseline|Total|Total of all reporting groups
379096|NCT00680316|B2|Baseline|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379097|NCT00680316|B1|Baseline|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379098|NCT00680316|P2|Participant Flow|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379099|NCT00680316|P1|Participant Flow|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379100|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379101|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379102|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379103|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379104|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379105|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379106|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379107|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379108|NCT00680316|E2|Reported Event|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
379109|NCT00680316|E1|Reported Event|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
379110|NCT00680186|B3|Baseline|Total|Total of all reporting groups
379111|NCT00680186|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
379112|NCT00680186|B1|Baseline|Dabigatran 150 mg|bid oral
379113|NCT00680186|P2|Participant Flow|Warfarin|PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
379114|NCT00680186|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
379115|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379116|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379117|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379118|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379119|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379120|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379121|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379122|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379123|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379124|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379125|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379126|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379127|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379128|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379129|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379130|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379131|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379132|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379133|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
379134|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
379135|NCT00680186|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
379136|NCT00680186|E1|Reported Event|Dabigatran 150 mg|bid oral
379137|NCT00680121|B3|Baseline|Total|Total of all reporting groups
379138|NCT00680121|B2|Baseline|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379139|NCT00680121|B1|Baseline|Control Group|Placebo; identically matched to Benfotiamine capsules
379140|NCT00680121|P2|Participant Flow|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379141|NCT00680121|P1|Participant Flow|Control Group|Placebo; identically matched to Benfotiamine capsules
379142|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379143|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
379144|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379145|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
379146|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379147|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
379148|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
379149|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
379153|NCT00680056|B2|Baseline|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
379154|NCT00680056|B1|Baseline|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
379155|NCT00680056|P2|Participant Flow|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
379156|NCT00680056|P1|Participant Flow|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
379157|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
379158|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
379159|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in either first intervention period or second intervention period.
379160|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
379161|NCT00680056|E2|Reported Event|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
379162|NCT00680056|E1|Reported Event|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
379163|NCT00680043|B4|Baseline|Total|Total of all reporting groups
379164|NCT00680043|B3|Baseline|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379165|NCT00680043|B2|Baseline|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379166|NCT00680043|B1|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379167|NCT00680043|P3|Participant Flow|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379168|NCT00680043|P2|Participant Flow|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379169|NCT00680043|P1|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379170|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379171|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379172|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379173|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379174|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379175|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379176|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379177|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379178|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379179|NCT00680043|E3|Reported Event|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379180|NCT00680043|E2|Reported Event|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
379181|NCT00680043|E1|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
379182|NCT00680017|B3|Baseline|Total|Total of all reporting groups
379183|NCT00680017|B2|Baseline|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
379184|NCT00680017|B1|Baseline|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
379185|NCT00680017|P2|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
379186|NCT00680017|P1|Participant Flow|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
379187|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
379188|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
379189|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
379190|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
379191|NCT00680017|E2|Reported Event|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
379192|NCT00680017|E1|Reported Event|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
379193|NCT00679952|B3|Baseline|Total|Total of all reporting groups
379194|NCT00679952|B2|Baseline|Natural Drainage Group|natural drainage group (ND group)
379195|NCT00679952|B1|Baseline|Closed Suction Drainage Group|closed suction drainage group (CD group)
379196|NCT00679952|P2|Participant Flow|Natural Drainage Group|natural drainage group (ND group)
379197|NCT00679952|P1|Participant Flow|Closed Suction Drainage Group|closed suction drainage group (CD group)
379198|NCT00679952|O2|Outcome|Natural Drainage Group|natural drainage group (ND group)
379199|NCT00679952|O1|Outcome|Closed Suction Drainage Group|closed suction drainage group (CD group)
379200|NCT00679952|E2|Reported Event|Natural Drainage Group|natural drainage group (ND group)
379201|NCT00679952|E1|Reported Event|Closed Suction Drainage Group|closed suction drainage group (CD group)
379202|NCT00679939|B3|Baseline|Total|Total of all reporting groups
379203|NCT00679939|B2|Baseline|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379204|NCT00679939|B1|Baseline|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379205|NCT00679939|P2|Participant Flow|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379206|NCT00679939|P1|Participant Flow|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379207|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379208|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379209|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379210|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379211|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379212|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379213|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379214|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379215|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379216|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379217|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379218|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379219|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379220|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379221|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379222|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379223|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379224|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379225|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379226|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379227|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379228|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379229|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379230|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379231|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379232|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379233|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379234|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379235|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379236|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379237|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379238|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379239|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379240|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379241|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379242|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379243|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379244|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379245|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379246|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379247|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379248|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379249|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379250|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379251|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379252|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379253|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379254|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379255|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379256|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379257|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379258|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379259|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379260|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379261|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379262|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379263|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379264|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379265|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379266|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379267|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379268|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379269|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379270|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379271|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379272|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379273|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379274|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379275|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379276|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379277|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379278|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379279|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379280|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379281|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379282|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379283|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379284|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379285|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379286|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379287|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379288|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379289|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379290|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379291|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379292|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379293|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379294|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379295|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379296|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379297|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379298|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379299|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379300|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379301|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379302|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379303|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379304|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379305|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379306|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379307|NCT00679939|O2|Outcome|Metformin|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379308|NCT00679939|O1|Outcome|Rosiglitazone|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379309|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379595|NCT00678899|E1|Reported Event|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
379310|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379311|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379312|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379313|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379314|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379315|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379316|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379317|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379318|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379319|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379320|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379321|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379322|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379323|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379324|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379325|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379326|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379327|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379328|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379329|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379330|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379331|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379332|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379333|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379334|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379335|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379336|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379337|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379338|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379339|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379340|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379341|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379342|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379343|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379344|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379345|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379346|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379347|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379348|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379349|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379350|NCT00679939|E4|Reported Event|Metformin: MET OL|At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379351|NCT00679939|E3|Reported Event|Rosiglitazone: MET OL|At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
379352|NCT00679939|E2|Reported Event|Metformin: DB|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period.
379596|NCT00678834|B4|Baseline|Total|Total of all reporting groups
379353|NCT00679939|E1|Reported Event|Rosiglitazone: DB|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period.
379354|NCT00679913|B3|Baseline|Total|Total of all reporting groups
379355|NCT00679913|B2|Baseline|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
379356|NCT00679913|B1|Baseline|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
379357|NCT00679913|P2|Participant Flow|Extended Pancreatoduodenectomy|extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.
379358|NCT00679913|P1|Participant Flow|Standard Pancreatoduodenectomy|standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
379359|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized"
379360|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
379361|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
379362|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
379363|NCT00679913|E2|Reported Event|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized."
379364|NCT00679913|E1|Reported Event|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
379365|NCT00679783|B8|Baseline|Total|Total of all reporting groups
379366|NCT00679783|B7|Baseline|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379367|NCT00679783|B6|Baseline|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379368|NCT00679783|B5|Baseline|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379369|NCT00679783|B4|Baseline|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379370|NCT00679783|B3|Baseline|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379371|NCT00679783|B2|Baseline|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379372|NCT00679783|B1|Baseline|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379373|NCT00679783|P7|Participant Flow|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379374|NCT00679783|P6|Participant Flow|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
381238|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
379375|NCT00679783|P5|Participant Flow|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379376|NCT00679783|P4|Participant Flow|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379377|NCT00679783|P3|Participant Flow|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379378|NCT00679783|P2|Participant Flow|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379379|NCT00679783|P1|Participant Flow|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379380|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379381|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379382|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379383|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379384|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379385|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379386|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379387|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379388|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379389|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379390|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379391|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379392|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379393|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379394|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379395|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379396|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379397|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379398|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379399|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379400|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379401|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379402|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379403|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
381239|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
379404|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379405|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379406|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379407|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379408|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379409|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379410|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379411|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379412|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379413|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379414|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379415|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379416|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379417|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379418|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379419|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379420|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379421|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379422|NCT00679783|E7|Reported Event|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
379423|NCT00679783|E6|Reported Event|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
379424|NCT00679783|E5|Reported Event|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
379425|NCT00679783|E4|Reported Event|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379426|NCT00679783|E3|Reported Event|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
379427|NCT00679783|E2|Reported Event|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
379428|NCT00679783|E1|Reported Event|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
379429|NCT00679627|B3|Baseline|Total|Total of all reporting groups
379430|NCT00679627|B2|Baseline|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379431|NCT00679627|B1|Baseline|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379638|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379432|NCT00679627|P2|Participant Flow|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379433|NCT00679627|P1|Participant Flow|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379434|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379435|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379436|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379437|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379438|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379439|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379440|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379441|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379442|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379443|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379444|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379445|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379446|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379482|NCT00679380|B2|Baseline|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
381240|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
379447|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379448|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379449|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379450|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379451|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379452|NCT00679627|E2|Reported Event|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
379453|NCT00679627|E1|Reported Event|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
379454|NCT00679432|B5|Baseline|Total|Total of all reporting groups
379455|NCT00679432|B4|Baseline|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379456|NCT00679432|B3|Baseline|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379457|NCT00679432|B2|Baseline|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379458|NCT00679432|B1|Baseline|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379459|NCT00679432|P4|Participant Flow|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379460|NCT00679432|P3|Participant Flow|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379461|NCT00679432|P2|Participant Flow|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379462|NCT00679432|P1|Participant Flow|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379463|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379464|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379465|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379466|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379467|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379468|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379469|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379470|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379471|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379472|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379473|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379474|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379475|NCT00679432|E4|Reported Event|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379476|NCT00679432|E3|Reported Event|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379477|NCT00679432|E2|Reported Event|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
379478|NCT00679432|E1|Reported Event|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
379479|NCT00679380|B5|Baseline|Total|Total of all reporting groups
379480|NCT00679380|B4|Baseline|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379481|NCT00679380|B3|Baseline|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379483|NCT00679380|B1|Baseline|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379484|NCT00679380|P4|Participant Flow|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379485|NCT00679380|P3|Participant Flow|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379486|NCT00679380|P2|Participant Flow|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379487|NCT00679380|P1|Participant Flow|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379488|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379489|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379490|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379491|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379492|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379493|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379494|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379495|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379496|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379497|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379498|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379499|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379500|NCT00679380|E4|Reported Event|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
379501|NCT00679380|E3|Reported Event|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
379502|NCT00679380|E2|Reported Event|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379503|NCT00679380|E1|Reported Event|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
379504|NCT00679354|B1|Baseline|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
379505|NCT00679354|P1|Participant Flow|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
379506|NCT00679354|O1|Outcome|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
379507|NCT00679354|E1|Reported Event|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
379508|NCT00679341|B3|Baseline|Total|Total of all reporting groups
379509|NCT00679341|B2|Baseline|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379510|NCT00679341|B1|Baseline|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379511|NCT00679341|P2|Participant Flow|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379512|NCT00679341|P1|Participant Flow|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379513|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379514|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379515|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379516|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379517|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379518|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379519|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379520|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379521|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379522|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379523|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379524|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379525|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379526|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379527|NCT00679341|E2|Reported Event|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
379528|NCT00679341|E1|Reported Event|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
379529|NCT00679302|B3|Baseline|Total|Total of all reporting groups
379530|NCT00679302|B2|Baseline|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
379531|NCT00679302|B1|Baseline|Placebo Group|Maalox and bitter mixture
379532|NCT00679302|P2|Participant Flow|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
379533|NCT00679302|P1|Participant Flow|Placebo Group|Maalox and bitter mixture
379534|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
379535|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
379536|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
379537|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
379538|NCT00679302|E2|Reported Event|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
379539|NCT00679302|E1|Reported Event|Placebo Group|Maalox and bitter mixture
379540|NCT00679263|B4|Baseline|Total|Total of all reporting groups
379541|NCT00679263|B3|Baseline|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
379542|NCT00679263|B2|Baseline|Placebo|MN-221 Placebo continuous infusion
379543|NCT00679263|B1|Baseline|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
379544|NCT00679263|P3|Participant Flow|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
379545|NCT00679263|P2|Participant Flow|Placebo|MN-221 Placebo continuous infusion
379546|NCT00679263|P1|Participant Flow|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
379547|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
379548|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
379549|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
379550|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
379551|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
379552|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
379553|NCT00679263|E3|Reported Event|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
379554|NCT00679263|E2|Reported Event|Placebo|MN-221 Placebo continuous infusion
379555|NCT00679263|E1|Reported Event|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
379556|NCT00679211|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379557|NCT00679211|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379594|NCT00678899|O1|Outcome|6 Months Postactivation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
381241|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
379558|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379559|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379560|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379561|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379562|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379563|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379564|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379565|NCT00679211|O2|Outcome|9 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379566|NCT00679211|O1|Outcome|6 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379567|NCT00679211|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
379568|NCT00679081|B1|Baseline|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
379569|NCT00679081|P1|Participant Flow|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
379570|NCT00679081|O3|Outcome|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
379571|NCT00679081|O2|Outcome|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
379572|NCT00679081|O1|Outcome|CelTx Site|Adverse events occurring at the CelTx site
379573|NCT00679081|E3|Reported Event|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
379574|NCT00679081|E2|Reported Event|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
379575|NCT00679081|E1|Reported Event|CelTx Site|Adverse events occurring at the CelTx site
379576|NCT00679055|B3|Baseline|Total|Total of all reporting groups
379577|NCT00679055|B2|Baseline|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379578|NCT00679055|B1|Baseline|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379579|NCT00679055|P2|Participant Flow|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379580|NCT00679055|P1|Participant Flow|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379581|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379582|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379583|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379584|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379585|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379586|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379587|NCT00679055|E2|Reported Event|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
379588|NCT00679055|E1|Reported Event|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
379589|NCT00678899|B1|Baseline|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
379590|NCT00678899|P1|Participant Flow|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
379591|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
379592|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
379593|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
379597|NCT00678834|B3|Baseline|Arm 3- Healthy + Tocotrienol 200 mg|Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
379598|NCT00678834|B2|Baseline|Arm 2 - Surgical + Tocopherol 200 mg|Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
379599|NCT00678834|B1|Baseline|Arm 1- Surgical + Tocotrienol 200 mg|Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
379600|NCT00678834|P3|Participant Flow|Arm 3- Healthy +Tocotrienol 400 mg|Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
379601|NCT00678834|P2|Participant Flow|Arm 2- Surgery + Tocopherol 200 mg|Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
379602|NCT00678834|P1|Participant Flow|Arm 1- Surgery + Tocotrienol 200 mg|Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
379603|NCT00678834|O13|Outcome|Arm 3: Healthy, Blood, Week 12|Blood levels of aTE after 12 weeks of supplementation (400mg/d)
379604|NCT00678834|O12|Outcome|Arm 3: Healthy, Skin, Week 0|baseline skin levels of aTE prior to supplementation
379605|NCT00678834|O11|Outcome|Arm 3: Healthy, Skin, Week 12|skin levels of aTE after 12 weeks of supplementation (400mg/d)
379606|NCT00678834|O10|Outcome|Arm 3: Healthy, Blood, Week 6|Blood levels of aTE after 6 weeks of supplementation (400mg/d)
379607|NCT00678834|O9|Outcome|Arm 3: Healthy, Blood, Week 0|Baseline blood levels of aTE prior to supplementation
379608|NCT00678834|O8|Outcome|Arm 2: Surgical, Liver|liver aTCP levels after supplementation (400mg/d)
379609|NCT00678834|O7|Outcome|Arm 2: Surgical, Heart|heart aTCP levels after supplementation (400mg/d)
379610|NCT00678834|O6|Outcome|Arm 2: Surgical, Brain|brain aTCP levels after supplementation (400mg/d)
379611|NCT00678834|O5|Outcome|Arm 2: Surgical, Adipose|adipose aTCP levels after supplementation (400mg/d)
379612|NCT00678834|O4|Outcome|Arm 1: Surgical, Liver|liver aTE levels after supplementation (400mg/d)
379613|NCT00678834|O3|Outcome|Arm 1: Surgical, Heart|heart aTE levels after supplementation (400mg/d)
379614|NCT00678834|O2|Outcome|Arm 1: Surgical, Brain|brain aTE levels after supplementation (400mg/d)
379615|NCT00678834|O1|Outcome|Arm 1: Surgical, Adipose|adipose aTE levels after supplementation (400mg/d)
379616|NCT00678834|E3|Reported Event|Arm 3|Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
379617|NCT00678834|E2|Reported Event|Arm 2|Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
379618|NCT00678834|E1|Reported Event|Arm 1|Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
379619|NCT00678795|B3|Baseline|Total|Total of all reporting groups
379620|NCT00678795|B2|Baseline|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379621|NCT00678795|B1|Baseline|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379622|NCT00678795|P2|Participant Flow|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379623|NCT00678795|P1|Participant Flow|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379624|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379625|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379626|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379627|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379628|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379629|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379630|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379631|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379632|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379633|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379634|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379635|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379636|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379637|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379639|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379640|NCT00678795|E2|Reported Event|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
379641|NCT00678795|E1|Reported Event|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
379642|NCT00678691|B3|Baseline|Total|Total of all reporting groups
379643|NCT00678691|B2|Baseline|A,2 Matching Placebo|placebo
379644|NCT00678691|B1|Baseline|A,1 Armodafinil Study Drug|armodafinil
379645|NCT00678691|P2|Participant Flow|A,2 Matching Placebo|placebo
379646|NCT00678691|P1|Participant Flow|A,1 Armodafinil Study Drug 50-250mg Flexible Dose|armodafinil
379647|NCT00678691|O2|Outcome|A,2 Matching Placebo|placebo
379648|NCT00678691|O1|Outcome|A,1 Armodafinil Study Drug|armodafinil
379649|NCT00678691|E2|Reported Event|A,2 Matching Placebo|placebo
379650|NCT00678691|E1|Reported Event|A,1 Armodafinil Study Drug|armodafinil
379651|NCT00678639|B3|Baseline|Total|Total of all reporting groups
379652|NCT00678639|B2|Baseline|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379653|NCT00678639|B1|Baseline|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379654|NCT00678639|P2|Participant Flow|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379655|NCT00678639|P1|Participant Flow|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379656|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379657|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379658|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379659|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379660|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit- Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379661|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379662|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379663|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379664|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379665|NCT00678639|E2|Reported Event|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
379666|NCT00678639|E1|Reported Event|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
379667|NCT00678587|B3|Baseline|Total|Total of all reporting groups
379668|NCT00678587|B2|Baseline|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379669|NCT00678587|B1|Baseline|Placebo|Matching placebo
379670|NCT00678587|P2|Participant Flow|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379671|NCT00678587|P1|Participant Flow|Placebo|Matching placebo
379672|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379673|NCT00678587|O1|Outcome|Placebo|Matching placebo
379674|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379675|NCT00678587|O1|Outcome|Placebo|Matching placebo
379676|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379677|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379678|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379679|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379680|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379681|NCT00678587|O1|Outcome|Placebo|Matching placebo
379682|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379683|NCT00678587|O1|Outcome|Placebo|Matching placebo
379684|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379685|NCT00678587|O1|Outcome|Placebo|Matching placebo
379686|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379687|NCT00678587|O1|Outcome|Placebo|Matching placebo
379688|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379689|NCT00678587|O1|Outcome|Placebo|Matching placebo
379690|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379691|NCT00678587|O1|Outcome|Placebo|Matching placebo
379692|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379693|NCT00678587|O1|Outcome|Placebo|Matching placebo
379694|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379695|NCT00678587|O1|Outcome|Placebo|Matching placebo
379696|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379697|NCT00678587|O1|Outcome|Placebo|Matching placebo
379698|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379699|NCT00678587|O1|Outcome|Placebo|Matching placebo
379700|NCT00678587|E2|Reported Event|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
379701|NCT00678587|E1|Reported Event|Placebo|Matching placebo
379702|NCT00678535|B3|Baseline|Total|Total of all reporting groups
379703|NCT00678535|B2|Baseline|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379704|NCT00678535|B1|Baseline|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379705|NCT00678535|P2|Participant Flow|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379706|NCT00678535|P1|Participant Flow|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379707|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379708|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379709|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379710|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379711|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379712|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379713|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379714|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379715|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379716|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379717|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379718|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379719|NCT00678535|E2|Reported Event|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379720|NCT00678535|E1|Reported Event|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
379759|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
381242|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
379721|NCT00678470|B1|Baseline|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
379722|NCT00678470|P1|Participant Flow|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
379723|NCT00678470|O1|Outcome|Intralesional Alefacept Followed by Intramuscular Alefacept.|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections to a single plaque (week 0). The plaques will be scored for response to intralesional injection (week 2). All patients will then receive intramuscular injection (week 2). The patients will then be scored for response to intramuscular injection (week 14). The number of patients who responded to both intralesional and intramuscular injection will be tabulated."
379724|NCT00678470|E1|Reported Event|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
379725|NCT00678418|B3|Baseline|Total|Total of all reporting groups
379726|NCT00678418|B2|Baseline|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379727|NCT00678418|B1|Baseline|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379728|NCT00678418|P2|Participant Flow|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379729|NCT00678418|P1|Participant Flow|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379730|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379731|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379732|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379733|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379734|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379735|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379736|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379737|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379738|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379739|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379740|NCT00678418|E2|Reported Event|Placebo|Single intramuscular (IM) injection administered every 4 weeks
379741|NCT00678418|E1|Reported Event|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
379742|NCT00678392|B3|Baseline|Total|Total of all reporting groups
379743|NCT00678392|B2|Baseline|Sorafenib|Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.
379744|NCT00678392|B1|Baseline|Axitinib|Axitinib (AG-013736) 5 mg tablet administered orally BID in cycles of 4 weeks.
379745|NCT00678392|P2|Participant Flow|Sorafenib|Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.
379746|NCT00678392|P1|Participant Flow|Axitinib|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) in cycles of 4 weeks.
379747|NCT00678392|O2|Outcome|Sorafenib|Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.
379748|NCT00678392|O1|Outcome|Axitinib|Axitinib (AG-013736) 5 mg tablet administered orally BID in cycles of 4 weeks.
379749|NCT00678392|E2|Reported Event|Sorafenib|Sorafenib 400 mg tablet administered orally BID in cycles of 4 weeks.
379750|NCT00678392|E1|Reported Event|Axitinib|Axitinib (AG-013736) 5 mg tablet administered orally BID in cycles of 4 weeks.
379751|NCT00678288|B3|Baseline|Total|Total of all reporting groups
379752|NCT00678288|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379753|NCT00678288|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379754|NCT00678288|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379755|NCT00678288|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379756|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379757|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379758|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
381243|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
379760|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379761|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379762|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379763|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379764|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379765|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379766|NCT00678288|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
379767|NCT00678288|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
379768|NCT00678249|B4|Baseline|Total|Total of all reporting groups
379769|NCT00678249|B3|Baseline|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379770|NCT00678249|B2|Baseline|PTA Only|Percutaneous Transluminal Angioplasty
379771|NCT00678249|B1|Baseline|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379772|NCT00678249|P3|Participant Flow|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379773|NCT00678249|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty
379774|NCT00678249|P1|Participant Flow|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379775|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379776|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379777|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379778|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379779|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379780|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379781|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379782|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379783|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379784|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379785|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379786|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379787|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379788|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379789|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379790|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379791|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379792|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379793|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379794|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379795|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379796|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379797|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379798|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379799|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379800|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
379801|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
380050|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
379802|NCT00678249|E3|Reported Event|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
379803|NCT00678249|E2|Reported Event|PTA Only|Percutaneous Transluminal Angioplasty
379804|NCT00678249|E1|Reported Event|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
379805|NCT00678210|B5|Baseline|Total|Total of all reporting groups
379806|NCT00678210|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379807|NCT00678210|B3|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379808|NCT00678210|B2|Baseline|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379809|NCT00678210|B1|Baseline|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379810|NCT00678210|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379811|NCT00678210|P3|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379812|NCT00678210|P2|Participant Flow|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379813|NCT00678210|P1|Participant Flow|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
379814|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379815|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379816|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379817|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379818|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379819|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379820|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379821|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379822|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379823|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379824|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379825|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379826|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379827|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379828|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379829|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379830|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379831|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379832|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379833|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379834|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379835|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379836|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379837|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379838|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379839|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379840|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379841|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379842|NCT00678210|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
379843|NCT00678210|E3|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
379844|NCT00678210|E2|Reported Event|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
379845|NCT00678210|E1|Reported Event|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
379846|NCT00678041|B3|Baseline|Total|Total of all reporting groups
379847|NCT00678041|B2|Baseline|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
379848|NCT00678041|B1|Baseline|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
379849|NCT00678041|P2|Participant Flow|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
379888|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
381244|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
379850|NCT00678041|P1|Participant Flow|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
379851|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379852|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379853|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379854|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379855|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379856|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
379857|NCT00678041|O2|Outcome|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
379858|NCT00678041|O1|Outcome|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
379859|NCT00678041|E2|Reported Event|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
379860|NCT00678041|E1|Reported Event|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
379861|NCT00678015|B1|Baseline|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379862|NCT00678015|P1|Participant Flow|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379863|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379864|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379865|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379866|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379867|NCT00678015|E1|Reported Event|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
379868|NCT00677924|B3|Baseline|Total|Total of all reporting groups
379869|NCT00677924|B2|Baseline|Zalutumumab 16 mg/kg|
379870|NCT00677924|B1|Baseline|Zalatumumab 8 mg/kg|
379871|NCT00677924|P2|Participant Flow|Zalutumumab 16 mg/kg|
379872|NCT00677924|P1|Participant Flow|Zalatumumab 8 mg/kg|
379873|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
379874|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
379875|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
379876|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
379877|NCT00677924|E2|Reported Event|Zalutumumab 16 mg/kg|
379878|NCT00677924|E1|Reported Event|Zalatumumab 8 mg/kg|
379879|NCT00677898|B3|Baseline|Total|Total of all reporting groups
379880|NCT00677898|B2|Baseline|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379881|NCT00677898|B1|Baseline|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379882|NCT00677898|P2|Participant Flow|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379883|NCT00677898|P1|Participant Flow|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379884|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379885|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379886|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379887|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
380051|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
381245|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
379889|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379890|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379891|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379892|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379893|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379894|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379895|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379896|NCT00677898|E2|Reported Event|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
379897|NCT00677898|E1|Reported Event|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
379898|NCT00677833|B5|Baseline|Total|Total of all reporting groups
379899|NCT00677833|B4|Baseline|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379900|NCT00677833|B3|Baseline|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379901|NCT00677833|B2|Baseline|Cohort 1: Artemether + Lumefantrine|"Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.~Cohort 1 included participants between >=5 years of age and <=12 years of age."
379902|NCT00677833|B1|Baseline|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.
379903|NCT00677833|P4|Participant Flow|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379904|NCT00677833|P3|Participant Flow|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379905|NCT00677833|P2|Participant Flow|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
379906|NCT00677833|P1|Participant Flow|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age.
379907|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379908|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379909|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379910|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
380052|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
379911|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379912|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379913|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379914|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379915|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379916|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379917|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379918|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379919|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379920|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379921|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379922|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379923|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379924|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379925|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379926|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379927|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379928|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
380053|NCT00677365|O1|Outcome|Placebo|Placebo Group
379929|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379930|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379931|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379932|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379933|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379934|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379935|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379936|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379937|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379938|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379939|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379940|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379941|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379942|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379943|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379944|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379945|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379946|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
381246|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
379947|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379948|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379949|NCT00677833|E4|Reported Event|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379950|NCT00677833|E3|Reported Event|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
379951|NCT00677833|E2|Reported Event|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
379952|NCT00677833|E1|Reported Event|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age.
379953|NCT00677820|B3|Baseline|Total|Total of all reporting groups
379954|NCT00677820|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379955|NCT00677820|B1|Baseline|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379956|NCT00677820|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379957|NCT00677820|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379958|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379959|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379960|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379961|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379962|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379963|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379964|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379965|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379966|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379995|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
381247|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
379967|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379968|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379969|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379970|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379971|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379972|NCT00677820|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
379973|NCT00677820|E1|Reported Event|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
379974|NCT00677807|B4|Baseline|Total|Total of all reporting groups
379975|NCT00677807|B3|Baseline|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379976|NCT00677807|B2|Baseline|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379977|NCT00677807|B1|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379978|NCT00677807|P3|Participant Flow|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379979|NCT00677807|P2|Participant Flow|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379980|NCT00677807|P1|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379981|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379982|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379983|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379984|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379985|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379986|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379987|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379988|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379989|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379990|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379991|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379992|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379993|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379994|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379996|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379997|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379998|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
379999|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380000|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380001|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380002|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380003|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380004|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380005|NCT00677807|E3|Reported Event|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380006|NCT00677807|E2|Reported Event|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380007|NCT00677807|E1|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
380008|NCT00677690|B3|Baseline|Total|Total of all reporting groups
380009|NCT00677690|B2|Baseline|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380010|NCT00677690|B1|Baseline|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380011|NCT00677690|P2|Participant Flow|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380012|NCT00677690|P1|Participant Flow|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380013|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380014|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380015|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380016|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380017|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380018|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380019|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380020|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380021|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380022|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380023|NCT00677690|E2|Reported Event|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
380024|NCT00677690|E1|Reported Event|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
380025|NCT00677534|B1|Baseline|Cholecalciferol 50,000 U|Vitamin D
380026|NCT00677534|P1|Participant Flow|Cholecalciferol 50,000 U|Vitamin D
380027|NCT00677534|O1|Outcome|Cholecalciferol 50,000 U|Vitamin D
380028|NCT00677534|E1|Reported Event|Cholecalciferol 50,000 U|Vitamin D
380029|NCT00677365|B5|Baseline|Total|Total of all reporting groups
380030|NCT00677365|B4|Baseline|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380031|NCT00677365|B3|Baseline|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380032|NCT00677365|B2|Baseline|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380033|NCT00677365|B1|Baseline|Placebo|Placebo Group
380034|NCT00677365|P4|Participant Flow|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380035|NCT00677365|P3|Participant Flow|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380036|NCT00677365|P2|Participant Flow|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380037|NCT00677365|P1|Participant Flow|Placebo|Placebo Group
380038|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380039|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380040|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380041|NCT00677365|O1|Outcome|Placebo|Placebo Group
380042|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380043|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380044|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380045|NCT00677365|O1|Outcome|Placebo|Placebo Group
380046|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380047|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380048|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380054|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380055|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380056|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380057|NCT00677365|O1|Outcome|Placebo|Placebo Group
380058|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380059|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380060|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380061|NCT00677365|O1|Outcome|Placebo|Placebo Group
380062|NCT00677365|E4|Reported Event|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
380063|NCT00677365|E3|Reported Event|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
380064|NCT00677365|E2|Reported Event|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
380065|NCT00677365|E1|Reported Event|Placebo|Placebo Group
380066|NCT00677352|B3|Baseline|Total|Total of all reporting groups
380067|NCT00677352|B2|Baseline|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380068|NCT00677352|B1|Baseline|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380069|NCT00677352|P2|Participant Flow|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380070|NCT00677352|P1|Participant Flow|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380071|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380072|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380073|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380074|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380075|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380091|NCT00677235|P1|Participant Flow|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380092|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380093|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380076|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380077|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380078|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380079|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380080|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380081|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380082|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380083|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380084|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380085|NCT00677352|E2|Reported Event|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
380086|NCT00677352|E1|Reported Event|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
380087|NCT00677235|B3|Baseline|Total|Total of all reporting groups
380088|NCT00677235|B2|Baseline|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380089|NCT00677235|B1|Baseline|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380090|NCT00677235|P2|Participant Flow|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380094|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380095|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380096|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380097|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380098|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380099|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380100|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380101|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380102|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380103|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380104|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380105|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380106|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380107|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380108|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380109|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380110|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380111|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380112|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380113|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380114|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380115|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380116|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380117|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380118|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380119|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380120|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380121|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380122|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380123|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380124|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380125|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380126|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380127|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380128|NCT00677235|E2|Reported Event|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
380129|NCT00677235|E1|Reported Event|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
380130|NCT00677014|B4|Baseline|Total|Total of all reporting groups
380131|NCT00677014|B3|Baseline|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
380132|NCT00677014|B2|Baseline|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
380133|NCT00677014|B1|Baseline|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
380134|NCT00677014|P3|Participant Flow|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
380135|NCT00677014|P2|Participant Flow|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
380136|NCT00677014|P1|Participant Flow|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
380137|NCT00677014|O3|Outcome|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
380138|NCT00677014|O2|Outcome|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
380139|NCT00677014|O1|Outcome|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
380140|NCT00677014|E3|Reported Event|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
380141|NCT00677014|E2|Reported Event|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
380142|NCT00677014|E1|Reported Event|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
380143|NCT00676806|B3|Baseline|Total|Total of all reporting groups
380144|NCT00676806|B2|Baseline|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
380145|NCT00676806|B1|Baseline|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
380146|NCT00676806|P2|Participant Flow|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
380147|NCT00676806|P1|Participant Flow|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
380148|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
380149|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
380150|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
380151|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
380152|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
380153|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
380154|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
380155|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
380156|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days."
380157|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days."
380158|NCT00676806|E2|Reported Event|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
380159|NCT00676806|E1|Reported Event|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
380160|NCT00676793|B1|Baseline|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380161|NCT00676793|P1|Participant Flow|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380162|NCT00676793|O1|Outcome|ECGC and Breast Cancer|The effect of ECGC extract on biomarkers in breast cancer.
380163|NCT00676793|O1|Outcome|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380164|NCT00676793|E1|Reported Event|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380165|NCT00676780|B1|Baseline|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380166|NCT00676780|P1|Participant Flow|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380167|NCT00676780|O1|Outcome|ECGC Extract|Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
380168|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
380169|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
380170|NCT00676780|E1|Reported Event|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
380171|NCT00676689|B1|Baseline|SAPIEN THV|
380172|NCT00676689|P1|Participant Flow|SAPIEN THV|
380173|NCT00676689|O1|Outcome|SAPIEN THV|
380174|NCT00676689|O1|Outcome|SAPIEN THV|
380175|NCT00676689|O1|Outcome|SAPIEN THV|
380176|NCT00676689|E1|Reported Event|SAPIEN THV|
380177|NCT00676676|B1|Baseline|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
380178|NCT00676676|P1|Participant Flow|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
380179|NCT00676676|O1|Outcome|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
380180|NCT00676676|E1|Reported Event|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
380181|NCT00676650|B3|Baseline|Total|Total of all reporting groups
380182|NCT00676650|B2|Baseline|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380183|NCT00676650|B1|Baseline|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380184|NCT00676650|P2|Participant Flow|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380185|NCT00676650|P1|Participant Flow|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380186|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380187|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380188|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380189|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380190|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380191|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380192|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380193|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380194|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380195|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380311|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380196|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380197|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380198|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380199|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380200|NCT00676650|E2|Reported Event|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
380201|NCT00676650|E1|Reported Event|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
380202|NCT00676520|B1|Baseline|Subjects Receiving the XIENCE V EECSS|
380203|NCT00676520|P1|Participant Flow|Subjects Receiving the XIENCE V EECSS|
380204|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
380205|NCT00676520|O4|Outcome|Treatment Satisfaction|
380206|NCT00676520|O3|Outcome|Angina Frequency|
380207|NCT00676520|O2|Outcome|Angina Stability|
380208|NCT00676520|O1|Outcome|Physical Limitations|
380209|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
380210|NCT00676520|O4|Outcome|Treatment Satisfaction|
380211|NCT00676520|O3|Outcome|Angina Frequency|
380212|NCT00676520|O2|Outcome|Angina Stability|
380213|NCT00676520|O1|Outcome|Physical Limitations|
380214|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
380215|NCT00676520|O4|Outcome|Treatment Satisfaction|
380216|NCT00676520|O3|Outcome|Angina Frequency|
380217|NCT00676520|O2|Outcome|Angina Stability|
380218|NCT00676520|O1|Outcome|Physical Limitations|
380219|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380220|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380221|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380222|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380223|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380224|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380225|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380226|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380227|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380228|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380229|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380230|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380231|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380232|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380233|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380234|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380235|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380236|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380237|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380238|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380239|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380240|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380241|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380242|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380243|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380244|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380245|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380246|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380247|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380248|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380249|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380250|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380251|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380252|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380253|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380254|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380255|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380256|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380257|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
380258|NCT00676520|E1|Reported Event|Subjects Receiving the XIENCE V EECSS|
380259|NCT00676494|B1|Baseline|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380312|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380260|NCT00676494|P1|Participant Flow|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380261|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380262|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380263|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380264|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
380265|NCT00676455|B1|Baseline|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
380266|NCT00676455|P1|Participant Flow|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
380267|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
380268|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
380269|NCT00676455|E1|Reported Event|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
380270|NCT00676403|B7|Baseline|Total|Total of all reporting groups
380271|NCT00676403|B6|Baseline|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380272|NCT00676403|B5|Baseline|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380273|NCT00676403|B4|Baseline|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380274|NCT00676403|B3|Baseline|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380275|NCT00676403|B2|Baseline|Pregabalin 50 mg|Single daily 50 mg oral dose.
380276|NCT00676403|B1|Baseline|Placebo|Single daily oral dose.
380277|NCT00676403|P6|Participant Flow|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380278|NCT00676403|P5|Participant Flow|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380279|NCT00676403|P4|Participant Flow|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380280|NCT00676403|P3|Participant Flow|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380281|NCT00676403|P2|Participant Flow|Pregabalin 50 mg|Single daily 50 mg oral dose.
380282|NCT00676403|P1|Participant Flow|Placebo|Single daily oral dose.
380283|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380284|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380285|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380286|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380287|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380288|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380289|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380290|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380291|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380292|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380293|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380294|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380295|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380296|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380297|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380298|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380299|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380300|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380301|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380302|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380303|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380304|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380305|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380306|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380307|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380308|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380309|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380310|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380313|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380314|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380315|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380316|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380317|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380318|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380319|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380320|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380321|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380322|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380323|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380324|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380325|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380326|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380327|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380328|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380329|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380330|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380331|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380332|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380333|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380334|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380335|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380336|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380337|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380338|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380339|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380340|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380341|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380342|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380343|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380344|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380345|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380346|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380347|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380348|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380349|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380350|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380351|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380352|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380353|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380354|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380355|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380356|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380357|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380358|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380359|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380360|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380361|NCT00676403|O6|Outcome|Pregablin 450 mg/Day|
380362|NCT00676403|O5|Outcome|Pregabalin 300 mg/Day|
380363|NCT00676403|O4|Outcome|Pregabalin 150 mg/Day|
380364|NCT00676403|O3|Outcome|Pregabalin 100 mg/Day|
380365|NCT00676403|O2|Outcome|Pregabalin 50 mg/Day|
380366|NCT00676403|O1|Outcome|Placebo|
380367|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380368|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380369|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380370|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380371|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380372|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380373|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380374|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380375|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380376|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380377|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380378|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380379|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380380|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380381|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380382|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380383|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380384|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380385|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380386|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380387|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380388|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380389|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380390|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380391|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380392|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380393|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380394|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380395|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380396|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380397|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380398|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380399|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380400|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380401|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
380402|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
380403|NCT00676403|E6|Reported Event|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
380404|NCT00676403|E5|Reported Event|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
380405|NCT00676403|E4|Reported Event|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
380406|NCT00676403|E3|Reported Event|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
380407|NCT00676403|E2|Reported Event|Pregabalin 50 mg|Single daily 50 mg oral dose.
380408|NCT00676403|E1|Reported Event|Placebo|Single daily oral dose.
380409|NCT00676364|B3|Baseline|Total|Total of all reporting groups
380410|NCT00676364|B2|Baseline|Investigational Group|Investigational group receiving blinded 4% lidocaine cream
380411|NCT00676364|B1|Baseline|ControI Group Receiving Placebo Cream Before Venipuncture|Experimential group receiving medicated topical cream prior to venipuncture
380412|NCT00676364|P2|Participant Flow|Investigational Group Receiving 4% Lidocaine|Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
380413|NCT00676364|P1|Participant Flow|ControI Group Receiving Placebo Cream|Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
380414|NCT00676364|O2|Outcome|Investigational Group Receiving 4% Lidocaine Cream|The investigational group received blinded 4% lidocaine cream under occlusive dressing for 15 minutes prior to venipuncture.
380415|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|The control group received blinded placebo cream under occlusive dressing for 15 minutes prior to venipuncture.
380416|NCT00676364|O2|Outcome|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
380417|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
380418|NCT00676364|E2|Reported Event|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
380419|NCT00676364|E1|Reported Event|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
380420|NCT00676338|B5|Baseline|Total|Total of all reporting groups
380552|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
380421|NCT00676338|B4|Baseline|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380422|NCT00676338|B3|Baseline|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380423|NCT00676338|B2|Baseline|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380424|NCT00676338|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380425|NCT00676338|P4|Participant Flow|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380426|NCT00676338|P3|Participant Flow|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380427|NCT00676338|P2|Participant Flow|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380428|NCT00676338|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380429|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380430|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380431|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380432|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380433|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380434|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380435|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380436|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380437|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380438|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380439|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380440|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380441|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380442|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380443|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380444|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380445|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380446|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380447|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380448|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380449|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380450|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380451|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380452|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380453|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380454|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380455|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380456|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380457|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380458|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380459|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380460|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380461|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380462|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380463|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380464|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380465|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380466|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380467|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380468|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380469|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380470|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380471|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380472|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380473|NCT00676338|E4|Reported Event|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
380474|NCT00676338|E3|Reported Event|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380475|NCT00676338|E2|Reported Event|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
380476|NCT00676338|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
380477|NCT00676208|B3|Baseline|Total|Total of all reporting groups
380478|NCT00676208|B2|Baseline|Comparison|Medical students who do not experience Shared Medical Appointments.
380479|NCT00676208|B1|Baseline|SMA Participants|Medical Students who were assigned to observe Shared Medical Appointments (SMA).
380480|NCT00676208|P2|Participant Flow|Comparison|Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
380481|NCT00676208|P1|Participant Flow|Intervention|Medical Students who are assigned to observe Shared Medical Appointments.
380482|NCT00676208|O2|Outcome|Comparison|Medical students who do not experience Shared Medical Appointments (SMA).
380483|NCT00676208|O1|Outcome|SMA Particiants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
380484|NCT00676208|O2|Outcome|Comparison|Medical Students who do not experience Shared Medical Appointments.
380485|NCT00676208|O1|Outcome|SMA Participants|Medical students who are assigned to observe Shared Medical Appointments (SMA).
380486|NCT00676208|E2|Reported Event|Comparison|Medical students who do not experience Shared Medical Appointments.
380487|NCT00676208|E1|Reported Event|SMA Participants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
380488|NCT00676182|B3|Baseline|Total|Total of all reporting groups
380489|NCT00676182|B2|Baseline|Telerehabilitation TBI/PTSD|"Telerehabilitation TBI/PTSD~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD"
380490|NCT00676182|B1|Baseline|Telerehabilitation TBI|"Telerehabilitation TBI~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI"
380491|NCT00676182|P1|Participant Flow|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380492|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
380493|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
380494|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
380495|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
380496|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for TBI/PTSD"
380497|NCT00676182|O1|Outcome|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380498|NCT00676182|O3|Outcome|Telerehabilitation 12 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380499|NCT00676182|O2|Outcome|Telerehabilitation 6 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380500|NCT00676182|O1|Outcome|Telerehabilitation Baseline|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380501|NCT00676182|O1|Outcome|Telerehabilitation|"Telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects"
380502|NCT00676182|E1|Reported Event|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
380503|NCT00676143|B3|Baseline|Total|Total of all reporting groups
380504|NCT00676143|B2|Baseline|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380505|NCT00676143|B1|Baseline|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
380506|NCT00676143|P2|Participant Flow|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380507|NCT00676143|P1|Participant Flow|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
380508|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380509|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380553|NCT00676130|E2|Reported Event|Placebo|Cephalexin plus placebo
380510|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380511|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380512|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380513|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380514|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380515|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380516|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380517|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380518|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380519|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380520|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380521|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380522|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380523|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380524|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380525|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380526|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380527|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380528|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380529|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380530|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380531|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380532|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380533|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380534|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380535|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380536|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380537|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380538|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380539|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380540|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380541|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380542|NCT00676143|E2|Reported Event|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
380543|NCT00676143|E1|Reported Event|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
380544|NCT00676130|B3|Baseline|Total|Total of all reporting groups
380545|NCT00676130|B2|Baseline|Placebo|Cephalexin plus placebo
380546|NCT00676130|B1|Baseline|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
380547|NCT00676130|P2|Participant Flow|Placebo|Cephalexin plus placebo
380548|NCT00676130|P1|Participant Flow|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
380549|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
380550|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
380551|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
380554|NCT00676130|E1|Reported Event|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
380555|NCT00676091|B3|Baseline|Total|Total of all reporting groups
380556|NCT00676091|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380557|NCT00676091|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380558|NCT00676091|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380559|NCT00676091|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380560|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380561|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380562|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380563|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380564|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380565|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380566|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380567|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380568|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380569|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380570|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380571|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380572|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380573|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380574|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380575|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380576|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380577|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380578|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380579|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380580|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380581|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380582|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380583|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
380584|NCT00676091|E6|Reported Event|Toddler Dose 7vPnC|"7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86."
380638|NCT00675909|B4|Baseline|Total|Total of all reporting groups
380639|NCT00675909|B3|Baseline|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
380874|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380585|NCT00676091|E5|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population."
380586|NCT00676091|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
380587|NCT00676091|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
380588|NCT00676091|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
380589|NCT00676091|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
380590|NCT00676065|B4|Baseline|Total|Total of all reporting groups
380591|NCT00676065|B3|Baseline|OC-other|Users of oral contraceptives containing other progestogens
380592|NCT00676065|B2|Baseline|OC-LNG|Users of oral contraceptives containing levonorgestrel
380593|NCT00676065|B1|Baseline|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380594|NCT00676065|P3|Participant Flow|OC-other|Users of oral contraceptives containing other progestogens
380595|NCT00676065|P2|Participant Flow|OC-LNG|Users of oral contraceptives containing levonorgestrel
380596|NCT00676065|P1|Participant Flow|Yasmin|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380597|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
380598|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
380599|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380600|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
380601|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
380602|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380603|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
380604|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
380605|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380606|NCT00676065|E3|Reported Event|OC-other|Users of oral contraceptives containing other progestogens
380607|NCT00676065|E2|Reported Event|OC-LNG|Users of oral contraceptives containing levonorgestrel
380608|NCT00676065|E1|Reported Event|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
380609|NCT00675987|B3|Baseline|Total|Total of all reporting groups
380610|NCT00675987|B2|Baseline|Placebo 1 Tab po QD|Placebo 1 tab po QD
380611|NCT00675987|B1|Baseline|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
380612|NCT00675987|P2|Participant Flow|Placebo 1 Tab po QD|Placebo 1 tab po QD
380613|NCT00675987|P1|Participant Flow|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
380614|NCT00675987|O2|Outcome|Losartan|
380615|NCT00675987|O1|Outcome|Placebo|
380616|NCT00675987|O2|Outcome|Losartan|
380617|NCT00675987|O1|Outcome|Placebo|
380618|NCT00675987|E2|Reported Event|Placebo 1 Tab po QD|Placebo 1 tab po QD
380619|NCT00675987|E1|Reported Event|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
380620|NCT00675948|B3|Baseline|Total|Total of all reporting groups
380621|NCT00675948|B2|Baseline|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380622|NCT00675948|B1|Baseline|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
380623|NCT00675948|P2|Participant Flow|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380624|NCT00675948|P1|Participant Flow|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
380625|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380626|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
380627|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380628|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
380629|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380630|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
380631|NCT00675948|E2|Reported Event|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
380632|NCT00675948|E1|Reported Event|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
380633|NCT00675922|B1|Baseline|Sulfamylon vs Silver Nitrate Solution|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
380634|NCT00675922|P1|Participant Flow|Sulfamylon Solution 5% and Silver Nitrate Soaks|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
380635|NCT00675922|O2|Outcome|Percent Infections: Silver Nitrate Site|Percent of sites that developed infections with Silver Nitrate soaks
380636|NCT00675922|O1|Outcome|Percent Infections:Sulfamylon Site|Percent of sites that developed infections with Sulfamylon soaks
380637|NCT00675922|E1|Reported Event|Sulfamylon Soaks, Silver Nitrate Soaks|Patients receive both treatments and each treated site is compared.
380640|NCT00675909|B2|Baseline|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
380641|NCT00675909|B1|Baseline|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
380642|NCT00675909|P3|Participant Flow|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
380643|NCT00675909|P2|Participant Flow|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
380644|NCT00675909|P1|Participant Flow|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
380645|NCT00675909|O3|Outcome|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
380646|NCT00675909|O2|Outcome|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
380647|NCT00675909|O1|Outcome|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
380648|NCT00675909|E3|Reported Event|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
380649|NCT00675909|E2|Reported Event|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
380650|NCT00675909|E1|Reported Event|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
380651|NCT00675792|B3|Baseline|Total|Total of all reporting groups
380652|NCT00675792|B2|Baseline|Neostigmine|50 µg/kg neostigmine
380653|NCT00675792|B1|Baseline|Sugammadex|4 mg/kg sugammadex
380654|NCT00675792|P2|Participant Flow|Neostigmine|50 µg/kg neostigmine
380655|NCT00675792|P1|Participant Flow|Sugammadex|4 mg/kg sugammadex
380656|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380657|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380658|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380659|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380660|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380661|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380662|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380663|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380664|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380665|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380666|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
380667|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
380668|NCT00675792|E2|Reported Event|Neostigmine|50 µg/kg neostigmine
380669|NCT00675792|E1|Reported Event|Sugammadex|4 mg/kg sugammadex
380670|NCT00675766|B5|Baseline|Total|Total of all reporting groups
380671|NCT00675766|B4|Baseline|Group 4|HIV-negative controls 18-40 years old
380672|NCT00675766|B3|Baseline|Group 3|HIV-negative controls 50 and older
380673|NCT00675766|B2|Baseline|Group 2|HIV-positive adults 18-40 years old
380674|NCT00675766|B1|Baseline|Group 1|HIV-positive adults 50 and older
380675|NCT00675766|P4|Participant Flow|Group 4|HIV-negative controls 18-40 years old
380676|NCT00675766|P3|Participant Flow|Group 3|HIV-negative controls 50 and older
380677|NCT00675766|P2|Participant Flow|Group 2|HIV-positive adults 18-40 years old
380678|NCT00675766|P1|Participant Flow|Group 1|HIV-positive adults 50 and older
380679|NCT00675766|O4|Outcome|Group 4|HIV-negative controls 18-40 years old
380680|NCT00675766|O3|Outcome|Group 3|HIV-negative controls 50 and older
380681|NCT00675766|O2|Outcome|Group 2|HIV-positive adults 18-40 years old
380682|NCT00675766|O1|Outcome|Group 1|HIV-positive adults 50 and older
380683|NCT00675766|E4|Reported Event|Group 4|HIV-negative controls 18-40 years old
380684|NCT00675766|E3|Reported Event|Group 3|HIV-negative controls 50 and older
380685|NCT00675766|E2|Reported Event|Group 2|HIV-positive adults 18-40 years old
380686|NCT00675766|E1|Reported Event|Group 1|HIV-positive adults 50 and older
380687|NCT00675597|B1|Baseline|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
380688|NCT00675597|P1|Participant Flow|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
380689|NCT00675597|O1|Outcome|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
380690|NCT00675597|E1|Reported Event|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
380691|NCT00675584|B3|Baseline|Total|Total of all reporting groups
380692|NCT00675584|B2|Baseline|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
380693|NCT00675584|B1|Baseline|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
380694|NCT00675584|P2|Participant Flow|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
380695|NCT00675584|P1|Participant Flow|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
380696|NCT00675584|O2|Outcome|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
380697|NCT00675584|O1|Outcome|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
380698|NCT00675584|E2|Reported Event|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
380699|NCT00675584|E1|Reported Event|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
380700|NCT00675558|B4|Baseline|Total|Total of all reporting groups
380701|NCT00675558|B3|Baseline|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380702|NCT00675558|B2|Baseline|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380703|NCT00675558|B1|Baseline|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380704|NCT00675558|P3|Participant Flow|Super-morbidly Obese (SMO)|"Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.~10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study."
380705|NCT00675558|P2|Participant Flow|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380706|NCT00675558|P1|Participant Flow|Non-Obese (NO)|Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380707|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380708|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380709|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380710|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380711|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380712|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380713|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380714|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380715|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380716|NCT00675558|E3|Reported Event|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380717|NCT00675558|E2|Reported Event|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
380718|NCT00675558|E1|Reported Event|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
380719|NCT00675506|B3|Baseline|Total|Total of all reporting groups
380720|NCT00675506|B2|Baseline|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380721|NCT00675506|B1|Baseline|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380722|NCT00675506|P2|Participant Flow|Placebo|"Participants received treatment with placebo medication.~Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380723|NCT00675506|P1|Participant Flow|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380724|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380725|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380726|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380871|NCT00674622|P1|Participant Flow|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380727|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
380728|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380729|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
380730|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380731|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
380732|NCT00675506|E2|Reported Event|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380733|NCT00675506|E1|Reported Event|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
380734|NCT00675441|B1|Baseline|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
380735|NCT00675441|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
380736|NCT00675441|O1|Outcome|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
380737|NCT00675441|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
380738|NCT00675428|B3|Baseline|Total|Total of all reporting groups
380739|NCT00675428|B2|Baseline|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380740|NCT00675428|B1|Baseline|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380741|NCT00675428|P2|Participant Flow|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380742|NCT00675428|P1|Participant Flow|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380743|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380744|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380745|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380746|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380747|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380748|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380749|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380750|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380751|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380752|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380753|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380754|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380755|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380756|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380757|NCT00675428|E2|Reported Event|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
380758|NCT00675428|E1|Reported Event|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
380759|NCT00675259|B1|Baseline|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
380760|NCT00675259|P1|Participant Flow|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
380761|NCT00675259|O3|Outcome|Patients With Hormone-responsive BC|Hormone-responsive breast cancer (BC)
380762|NCT00675259|O2|Outcome|Patients With pCR|Pathologic complete response (pCR)
380763|NCT00675259|O1|Outcome|Patients With TNBC|Women with triple negative breast cancer (TNBC)
380764|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
380765|NCT00675259|O1|Outcome|Adjuvant Bevacizumab|Patients received 6 months of adjuvant bevacizumab therapy
380766|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
380767|NCT00675259|E1|Reported Event|Toxicities During Neoadjuvant Chemotherapy|
380768|NCT00675103|B1|Baseline|Pegloticase 8 mg Every 2 Wks|
380769|NCT00675103|P1|Participant Flow|Pegloticase 8 mg Every 2 Wks|
380770|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
380771|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
380772|NCT00675103|E1|Reported Event|Pegloticase 8 mg Every 2 Wks|
380773|NCT00674986|B3|Baseline|Total|Total of all reporting groups
380774|NCT00674986|B2|Baseline|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380775|NCT00674986|B1|Baseline|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380776|NCT00674986|P2|Participant Flow|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380777|NCT00674986|P1|Participant Flow|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380778|NCT00674986|O1|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380779|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380780|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380781|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380782|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380783|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380784|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380785|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380786|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380787|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380788|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380872|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380873|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380789|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380790|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380791|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380792|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380793|NCT00674986|E2|Reported Event|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
380794|NCT00674986|E1|Reported Event|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
380795|NCT00674973|B3|Baseline|Total|Total of all reporting groups
380796|NCT00674973|B2|Baseline|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380797|NCT00674973|B1|Baseline|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380798|NCT00674973|P2|Participant Flow|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380799|NCT00674973|P1|Participant Flow|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380800|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380801|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380802|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380803|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380804|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380805|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380806|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380807|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380808|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380809|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380810|NCT00674973|E2|Reported Event|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
380811|NCT00674973|E1|Reported Event|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
380812|NCT00674765|B3|Baseline|Total|Total of all reporting groups
380813|NCT00674765|B2|Baseline|Placebo|"Placebo~Placebo: 400 mg/day"
380814|NCT00674765|B1|Baseline|Seroquel|"Seroquel~Seroquel: 400 mg/day"
380815|NCT00674765|P2|Participant Flow|Placebo|"Placebo~Placebo: 400 mg/day"
380816|NCT00674765|P1|Participant Flow|Seroquel|"Seroquel~Seroquel: 400 mg/day"
380817|NCT00674765|O2|Outcome|Placebo Sugar Pill|"Placebo~Placebo: 400 mg/day"
380818|NCT00674765|O1|Outcome|Seroquel (Quetiapine)|"Seroquel (quetiapine)~Seroquel: 400 mg/day"
380819|NCT00674765|E2|Reported Event|Placebo|"Placebo~Placebo: 400 mg/day"
380820|NCT00674765|E1|Reported Event|Seroquel|"Seroquel~Seroquel: 400 mg/day"
380821|NCT00674739|B4|Baseline|Total|Total of all reporting groups
380822|NCT00674739|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380823|NCT00674739|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380824|NCT00674739|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380825|NCT00674739|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380826|NCT00674739|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380827|NCT00674739|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380828|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380829|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380830|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380831|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380832|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380833|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380834|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380835|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380836|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380837|NCT00674739|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
380838|NCT00674739|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
380839|NCT00674739|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
380840|NCT00674700|B4|Baseline|Total|Total of all reporting groups
380841|NCT00674700|B3|Baseline|Placebo|Placebo tablet
380842|NCT00674700|B2|Baseline|500 IR|500 IR house dust mites allergen extract tablet
380843|NCT00674700|B1|Baseline|300 IR|300 IR house dust mites allergen extract tablet
380844|NCT00674700|P3|Participant Flow|Placebo|Placebo tablet
380845|NCT00674700|P2|Participant Flow|500 IR|500 IR house dust mites allergen extract tablet
380846|NCT00674700|P1|Participant Flow|300 IR|300 IR house dust mites allergen extract tablet
380847|NCT00674700|O3|Outcome|Placebo|Placebo tablet
380848|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
380849|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
380850|NCT00674700|O3|Outcome|Placebo|Placebo tablet
380851|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
380852|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
380853|NCT00674700|E3|Reported Event|Placebo|Placebo tablet
380854|NCT00674700|E2|Reported Event|500 IR|500 IR house dust mites allergen extract tablet
380855|NCT00674700|E1|Reported Event|300 IR|300 IR house dust mites allergen extract tablet
380856|NCT00674661|B3|Baseline|Total|Total of all reporting groups
380857|NCT00674661|B2|Baseline|Control Group|riboflavin opthalmic solution without UVA irradiation
380858|NCT00674661|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
380859|NCT00674661|P2|Participant Flow|Control Group|riboflavin opthalmic solution without UVA irradiation
380860|NCT00674661|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
380861|NCT00674661|O2|Outcome|Control Group|riboflavin opthalmic solution without UVA irradiation
380862|NCT00674661|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
380863|NCT00674661|E2|Reported Event|Control Group|riboflavin opthalmic solution without UVA irradiation
380864|NCT00674661|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
380865|NCT00674622|B4|Baseline|Total|Total of all reporting groups
380866|NCT00674622|B3|Baseline|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380867|NCT00674622|B2|Baseline|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380868|NCT00674622|B1|Baseline|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380869|NCT00674622|P3|Participant Flow|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380870|NCT00674622|P2|Participant Flow|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380875|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380876|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380877|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380878|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380879|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380880|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380881|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380882|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380883|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380884|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380885|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380886|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380887|NCT00674622|E3|Reported Event|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
380888|NCT00674622|E2|Reported Event|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
380889|NCT00674622|E1|Reported Event|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
380890|NCT00674609|B4|Baseline|Total|Total of all reporting groups
380891|NCT00674609|B3|Baseline|Placebo|Each 100 uL actuation contained colourant and excipients
380892|NCT00674609|B2|Baseline|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
380893|NCT00674609|B1|Baseline|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
380894|NCT00674609|P3|Participant Flow|Placebo|Each 100 uL actuation contained colourant and excipients
380895|NCT00674609|P2|Participant Flow|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
380896|NCT00674609|P1|Participant Flow|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
380897|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380898|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380899|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380900|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380901|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380902|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380903|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380904|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380905|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380906|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380907|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380908|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380909|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380910|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380911|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380912|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380913|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380948|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380914|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380915|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380916|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380917|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380918|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380919|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380920|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380921|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
380922|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
380923|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
380924|NCT00674609|E3|Reported Event|Placebo|Maximum number of daily sprays was 48
380925|NCT00674609|E2|Reported Event|THC Alone|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
380926|NCT00674609|E1|Reported Event|Sativex|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
380927|NCT00674492|B1|Baseline|Group 1|patients who initiated antiviral treatment for hepatitis C
380928|NCT00674492|P1|Participant Flow|Group 1|patients who initiated antiviral treatment for hepatitis C
380929|NCT00674492|O1|Outcome|Group 1|patients who initiated antiviral treatment for hepatitis C
380930|NCT00674492|E1|Reported Event|Group 1|patients who initiated antiviral treatment for hepatitis C
380931|NCT00674362|B3|Baseline|Total|Total of all reporting groups
380932|NCT00674362|B2|Baseline|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380933|NCT00674362|B1|Baseline|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380934|NCT00674362|P2|Participant Flow|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380935|NCT00674362|P1|Participant Flow|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380936|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380937|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380938|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380939|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380940|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380941|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380942|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380943|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380944|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380945|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380946|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380947|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
381218|NCT00673452|P1|Participant Flow|Duloxetine|60-120 mg, oral, daily, 12 weeks
381219|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
380949|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380950|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380951|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380952|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380953|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380954|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380955|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380956|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380957|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380958|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380959|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380960|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380961|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380962|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380963|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380964|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380965|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380966|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380967|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380968|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380969|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380970|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380971|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380972|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380973|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380974|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380975|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380976|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380977|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380978|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380979|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380980|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380981|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
381220|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
380982|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380983|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380984|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380985|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380986|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380987|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380988|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380989|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380990|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380991|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380992|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380993|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380994|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380995|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380996|NCT00674362|E3|Reported Event|Open Label Phase|At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
380997|NCT00674362|E2|Reported Event|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
380998|NCT00674362|E1|Reported Event|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
380999|NCT00674323|B4|Baseline|Total|Total of all reporting groups
381000|NCT00674323|B3|Baseline|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381001|NCT00674323|B2|Baseline|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381002|NCT00674323|B1|Baseline|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381003|NCT00674323|P3|Participant Flow|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381047|NCT00674115|P2|Participant Flow|Prilosec, Zegerid, Sodium Bicarbonate|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
381221|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
381004|NCT00674323|P2|Participant Flow|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381005|NCT00674323|P1|Participant Flow|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381006|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381007|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381008|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381009|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381010|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381011|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381012|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381013|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381014|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381098|NCT00673816|O1|Outcome|Left Eye|
381015|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381016|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381017|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
381018|NCT00674323|E3|Reported Event|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
381019|NCT00674323|E2|Reported Event|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
381020|NCT00674323|E1|Reported Event|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
381021|NCT00674206|B1|Baseline|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
381022|NCT00674206|P1|Participant Flow|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
381023|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
381024|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
381025|NCT00674206|E1|Reported Event|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
381026|NCT00674154|B3|Baseline|Total|Total of all reporting groups
381027|NCT00674154|B2|Baseline|Placebo|Placebo, two tablets daily in 52 weeks.
381028|NCT00674154|B1|Baseline|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
381029|NCT00674154|P2|Participant Flow|Placebo|Placebo, two tablets daily in 52 weeks.
381030|NCT00674154|P1|Participant Flow|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
381031|NCT00674154|O2|Outcome|Placebo|Placebo, two tablets daily in 52 weeks.
381032|NCT00674154|O1|Outcome|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
381033|NCT00674154|E2|Reported Event|Placebo|Placebo, two tablets daily in 52 weeks.
381034|NCT00674154|E1|Reported Event|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
381035|NCT00674128|B3|Baseline|Total|Total of all reporting groups
381036|NCT00674128|B2|Baseline|Suture|Polyglactin 910 suture.
381037|NCT00674128|B1|Baseline|Adhesive|Cyanoacrylate tissue adhesive.
381038|NCT00674128|P2|Participant Flow|Suture|Polyglactin 910 suture.
381039|NCT00674128|P1|Participant Flow|Adhesive|Cyanoacrylate tissue adhesive.
381040|NCT00674128|O2|Outcome|Suture|Polyglactin 910 suture.
381041|NCT00674128|O1|Outcome|Adhesive|Cyanoacrylate tissue adhesive.
381042|NCT00674128|E2|Reported Event|Suture|Polyglactin 910 suture
381043|NCT00674128|E1|Reported Event|Adhesive|Cyanoacrylate tissue adhesive.
381044|NCT00674115|B1|Baseline|Entire Study Population|
381045|NCT00674115|P4|Participant Flow|Prilosec, Zegerid|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
381046|NCT00674115|P3|Participant Flow|Zegerid, Prilosec|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
381213|NCT00673465|E1|Reported Event|Placebo|Participants received placebo daily for 4 weeks during one of 3 parts of the study.
381214|NCT00673452|B3|Baseline|Total|Total of all reporting groups
381048|NCT00674115|P1|Participant Flow|Zegerid, Prilosec, Sodium Bicarbonate|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
381049|NCT00674115|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
381050|NCT00674115|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
381051|NCT00674115|E5|Reported Event|Prilosec (1-Day Dosing)|
381052|NCT00674115|E4|Reported Event|Zegerid (1-Day Dosing)|
381053|NCT00674115|E3|Reported Event|Sodium Bicarbonate (1-Day Dosing)|Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
381054|NCT00674115|E2|Reported Event|Prilosec (7-Day Dosing)|
381055|NCT00674115|E1|Reported Event|Zegerid (7-Day Dosing)|
381056|NCT00673959|B1|Baseline|Overall Study|
381057|NCT00673959|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
381058|NCT00673959|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received Lubricant Drops first, then received Optive Drops
381059|NCT00673959|O2|Outcome|Optive Lubricant Eye Drop|
381060|NCT00673959|O1|Outcome|Lubricant Eye Drop FID 111421|
381061|NCT00673959|E2|Reported Event|Optive Lubricant Eye Drop|
381062|NCT00673959|E1|Reported Event|Lubricant Eye Drop FID 111421|
381063|NCT00673933|B1|Baseline|Visonac and Vehicle Cream With PDT|Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
381064|NCT00673933|P1|Participant Flow|Visonac Cream With PDT and Vehicle and PDT|Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
381065|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381066|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381067|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381068|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381069|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381070|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381071|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381072|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381073|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381074|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381075|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381076|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381077|NCT00673933|E2|Reported Event|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381078|NCT00673933|E1|Reported Event|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
381079|NCT00673881|B1|Baseline|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381080|NCT00673881|P1|Participant Flow|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381081|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381082|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381083|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381084|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381085|NCT00673881|E1|Reported Event|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
381086|NCT00673855|B1|Baseline|Overall Study|
381087|NCT00673855|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
381088|NCT00673855|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received lubricant Drops first, then received Optive Drops
381089|NCT00673855|O2|Outcome|Lubricant Eye Drops|Lubricant Eye Drops
381090|NCT00673855|O1|Outcome|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
381091|NCT00673855|E2|Reported Event|Lubricant Eye Drops|Lubricant Eye Drops
381092|NCT00673855|E1|Reported Event|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
381093|NCT00673816|B1|Baseline|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
381094|NCT00673816|P1|Participant Flow|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
381095|NCT00673816|O2|Outcome|Right Eye|
381096|NCT00673816|O1|Outcome|Left Eye|
381097|NCT00673816|O2|Outcome|Right Eye|
381099|NCT00673816|E1|Reported Event|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
381100|NCT00673764|B1|Baseline|Overall Study|Overall Study
381101|NCT00673764|P2|Participant Flow|Optive, Then Systane Ultra|Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
381102|NCT00673764|P1|Participant Flow|Systane Ultra, Then Optive|Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
381103|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
381104|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
381105|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
381106|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
381107|NCT00673764|E2|Reported Event|Optive|Optive Lubricant Eye Drops
381108|NCT00673764|E1|Reported Event|Systane Ultra|Systane Ultra Lubricant Eye Drops.
381109|NCT00673738|B1|Baseline|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
381110|NCT00673738|P1|Participant Flow|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
381111|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
381112|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
381113|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
381114|NCT00673738|E1|Reported Event|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
381115|NCT00673712|B3|Baseline|Total|Total of all reporting groups
381116|NCT00673712|B2|Baseline|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381117|NCT00673712|B1|Baseline|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381118|NCT00673712|P2|Participant Flow|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381119|NCT00673712|P1|Participant Flow|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381120|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381121|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381122|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381123|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381124|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381125|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381126|NCT00673712|E2|Reported Event|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
381127|NCT00673712|E1|Reported Event|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
381128|NCT00673673|B1|Baseline|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381129|NCT00673673|P1|Participant Flow|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381130|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381215|NCT00673452|B2|Baseline|Placebo|oral, daily, 12 weeks
381131|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381132|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381133|NCT00673673|E1|Reported Event|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
381134|NCT00673660|B1|Baseline|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381135|NCT00673660|P1|Participant Flow|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381136|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381137|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381138|NCT00673660|O2|Outcome|Non-compliant With Statin Treatment|Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381139|NCT00673660|O1|Outcome|Compliant With Statin Treatment|Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381140|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381141|NCT00673660|E4|Reported Event|Statins Visit 5|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381142|NCT00673660|E3|Reported Event|Statins at Visit 4|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381143|NCT00673660|E2|Reported Event|Statins at Visit 3|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381144|NCT00673660|E1|Reported Event|Statins at Visit 2|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
381145|NCT00673595|B3|Baseline|Total|Total of all reporting groups
381146|NCT00673595|B2|Baseline|Placebo|Participants on this arm will receive placebo tablets for 15 days.
381147|NCT00673595|B1|Baseline|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
381148|NCT00673595|P2|Participant Flow|Placebo|Participants on this arm will receive placebo tablets for 15 days.
381149|NCT00673595|P1|Participant Flow|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
381150|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
381151|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
381152|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
381153|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
381154|NCT00673595|E2|Reported Event|Placebo|Participants on this arm will receive placebo tablets for 15 days.
381155|NCT00673595|E1|Reported Event|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
381156|NCT00673465|B1|Baseline|All Treated Participants|All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study.
381157|NCT00673465|P12|Participant Flow|Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
381158|NCT00673465|P11|Participant Flow|Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
381159|NCT00673465|P10|Participant Flow|Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
381160|NCT00673465|P9|Participant Flow|Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
381161|NCT00673465|P8|Participant Flow|Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
381162|NCT00673465|P7|Participant Flow|Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
381163|NCT00673465|P6|Participant Flow|Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
381216|NCT00673452|B1|Baseline|Duloxetine|60-120 mg, oral, daily, 12 weeks
381164|NCT00673465|P5|Participant Flow|Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
381165|NCT00673465|P4|Participant Flow|Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
381166|NCT00673465|P3|Participant Flow|Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3).
381167|NCT00673465|P2|Participant Flow|Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3).
381168|NCT00673465|P1|Participant Flow|Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
381169|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381170|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381171|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381172|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381173|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381174|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381175|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381176|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381177|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381178|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381179|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381180|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381181|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381182|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381183|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381184|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381185|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381186|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381187|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381188|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381189|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381190|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381191|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381192|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381193|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381194|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381195|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381196|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381197|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381198|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381199|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381200|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381201|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381202|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381203|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381204|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381205|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381206|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381207|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381208|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
381209|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
381210|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381211|NCT00673465|E3|Reported Event|Metformin|Participants received metformin daily for 4 weeks during one of 3 parts of the study.
381212|NCT00673465|E2|Reported Event|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
381248|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
381249|NCT00673452|E2|Reported Event|Placebo|oral, daily, 12 weeks
381250|NCT00673452|E1|Reported Event|Duloxetine|60-120 mg, oral, daily, 12 weeks
381251|NCT00673439|B1|Baseline|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
381252|NCT00673439|P1|Participant Flow|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
381253|NCT00673439|O1|Outcome|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg|
381254|NCT00673439|E1|Reported Event|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
381255|NCT00673400|B1|Baseline|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
381256|NCT00673400|P1|Participant Flow|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
381257|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
381258|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
381259|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
381260|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
381261|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
381262|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
381263|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
381264|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
381265|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
381266|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
381267|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
381268|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
381269|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured within one month before surgery
381270|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
381271|NCT00673400|E1|Reported Event|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
381272|NCT00673387|B9|Baseline|Total|Total of all reporting groups
381273|NCT00673387|B8|Baseline|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381274|NCT00673387|B7|Baseline|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381275|NCT00673387|B6|Baseline|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381276|NCT00673387|B5|Baseline|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381277|NCT00673387|B4|Baseline|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381278|NCT00673387|B3|Baseline|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381279|NCT00673387|B2|Baseline|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381280|NCT00673387|B1|Baseline|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381281|NCT00673387|P8|Participant Flow|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381282|NCT00673387|P7|Participant Flow|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381283|NCT00673387|P6|Participant Flow|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381284|NCT00673387|P5|Participant Flow|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381285|NCT00673387|P4|Participant Flow|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381286|NCT00673387|P3|Participant Flow|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381287|NCT00673387|P2|Participant Flow|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381288|NCT00673387|P1|Participant Flow|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381503|NCT00673361|B1|Baseline|"Chemo-Switch Regimen"|
381504|NCT00673361|P1|Participant Flow|"Chemo-Switch Regimen"|
381289|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381290|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381291|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381292|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381293|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381294|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381295|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381296|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381297|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381298|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381299|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381300|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381301|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381302|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381303|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381304|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381305|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381306|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381307|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381308|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381309|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381310|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381311|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381312|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381313|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381314|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381315|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381316|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381317|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381318|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381319|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381320|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381321|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381322|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381323|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381324|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381325|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381326|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381327|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381328|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381329|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381330|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381331|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381332|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381333|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381334|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381335|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381336|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381337|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381338|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381339|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381340|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381341|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381342|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381505|NCT00673361|O1|Outcome|Terminated Studybefore Accrual Goal|
381343|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381344|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381345|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381346|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381347|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381348|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381349|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381350|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381351|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381352|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381353|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381354|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381355|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381356|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381357|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381358|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381359|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381360|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381361|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381362|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381363|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381364|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381365|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381366|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381367|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381368|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381506|NCT00673361|E1|Reported Event|"Chemo-Switch Regimen"|
381539|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381369|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381370|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381371|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381372|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381373|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381374|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381375|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381376|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381377|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381378|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381379|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381380|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381381|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381382|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381383|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381384|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381385|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381386|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381387|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381388|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381389|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381390|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381391|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381392|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381393|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381394|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381395|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381396|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381397|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381398|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381399|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381400|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381401|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381402|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381403|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381404|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381405|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381406|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381407|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381408|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381409|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381410|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381411|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381412|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381413|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381414|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381415|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381416|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381417|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381418|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381419|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381420|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381421|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381422|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381423|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381424|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381425|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381426|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381427|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381428|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381429|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381430|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381431|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381432|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381433|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381434|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381435|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381436|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381437|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381438|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381439|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381440|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381441|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381442|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381443|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381444|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381445|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381446|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381447|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381448|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381449|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381536|NCT00673231|O1|Outcome|Placebo|Placebo
381537|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381450|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381451|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381452|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381453|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381454|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381455|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381456|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381457|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381458|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381459|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381460|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381461|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381462|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381463|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381464|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381465|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381466|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381467|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381468|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381469|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381470|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381471|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381472|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381473|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381474|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381538|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381475|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381476|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381477|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381478|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381479|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381480|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381481|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381482|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381483|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381484|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381485|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381486|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381487|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381488|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381489|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381490|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
381491|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381492|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381493|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381494|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381495|NCT00673387|E8|Reported Event|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381496|NCT00673387|E7|Reported Event|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381497|NCT00673387|E6|Reported Event|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381498|NCT00673387|E5|Reported Event|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
381499|NCT00673387|E4|Reported Event|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
381500|NCT00673387|E3|Reported Event|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
381501|NCT00673387|E2|Reported Event|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
381502|NCT00673387|E1|Reported Event|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
381507|NCT00673257|B1|Baseline|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
381508|NCT00673257|P1|Participant Flow|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
381509|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
381510|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
381511|NCT00673257|E1|Reported Event|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
381512|NCT00673231|B5|Baseline|Total|Total of all reporting groups
381513|NCT00673231|B4|Baseline|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381514|NCT00673231|B3|Baseline|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381515|NCT00673231|B2|Baseline|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381516|NCT00673231|B1|Baseline|Placebo|Placebo
381517|NCT00673231|P4|Participant Flow|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381518|NCT00673231|P3|Participant Flow|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381519|NCT00673231|P2|Participant Flow|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381520|NCT00673231|P1|Participant Flow|Placebo|Placebo
381521|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381522|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381523|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381524|NCT00673231|O1|Outcome|Placebo|Placebo
381525|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381526|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381527|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381528|NCT00673231|O1|Outcome|Placebo|Placebo
381529|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381530|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381531|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381532|NCT00673231|O1|Outcome|Placebo|Placebo
381533|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381534|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381535|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381540|NCT00673231|O1|Outcome|Placebo|Placebo
381541|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381542|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381543|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381544|NCT00673231|O1|Outcome|Placebo|Placebo
381545|NCT00673231|E4|Reported Event|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
381546|NCT00673231|E3|Reported Event|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
381547|NCT00673231|E2|Reported Event|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
381548|NCT00673231|E1|Reported Event|Placebo|Placebo
381549|NCT00673179|B3|Baseline|Total|Total of all reporting groups
381550|NCT00673179|B2|Baseline|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381551|NCT00673179|B1|Baseline|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381552|NCT00673179|P2|Participant Flow|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381553|NCT00673179|P1|Participant Flow|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381554|NCT00673179|O2|Outcome|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381555|NCT00673179|O1|Outcome|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381556|NCT00673179|E2|Reported Event|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
381557|NCT00673179|E1|Reported Event|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
381558|NCT00673127|B1|Baseline|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
381559|NCT00673127|P1|Participant Flow|KHAD|KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
381560|NCT00673127|O1|Outcome|KHAD|KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
381561|NCT00673127|O1|Outcome|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
381562|NCT00673127|E1|Reported Event|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
381563|NCT00673114|B1|Baseline|Transplant Recipients|single arm study
381564|NCT00673114|P1|Participant Flow|Transplant Recipients|Transplant Recipients
381565|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381566|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381567|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381568|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381569|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381570|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381571|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381572|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
381573|NCT00673114|E1|Reported Event|Transplant Recipients|single arm study
381574|NCT00673075|B3|Baseline|Total|Total of all reporting groups
381575|NCT00673075|B2|Baseline|Carvedilol|Encapsulated Carvedilol
381576|NCT00673075|B1|Baseline|Nebivolol|Encapsulated Nebivolol
381577|NCT00673075|P2|Participant Flow|Carvedilol|Encapsulated Carvedilol
381578|NCT00673075|P1|Participant Flow|Nebivolol|Encapsulated Nebivolol
381579|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
381580|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
381581|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
381582|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
381583|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
381584|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
381585|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
381586|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
381587|NCT00673075|E4|Reported Event|Carvedilol Down-Titration|Encapsulated Carvedilol Down-Titration Period
381588|NCT00673075|E3|Reported Event|Nebivolol Down-Titration|Encapsulated Nebivolol Down-Titration Period
381589|NCT00673075|E2|Reported Event|Carvedilol Combined Up-Titration and Stable-dose|Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods
381590|NCT00673075|E1|Reported Event|Nebivolol Combined Up-Titration and Stable-dose|Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods
381591|NCT00673049|B3|Baseline|Total|Total of all reporting groups
381592|NCT00673049|B2|Baseline|Erlotinib (as Randomized)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
381593|NCT00673049|B1|Baseline|Figitumumab + Erlotinib (as Randomized)|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
381594|NCT00673049|P4|Participant Flow|Erlotinib, Then Figitumumab|Figitumumab 20 mg/kg was given as a single-agent therapy to participants who had disease progression on erlotinib alone. Figitumumab was administered in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381595|NCT00673049|P3|Participant Flow|Randomized to Figi + Erlo Arm But Treated Only With Erlo|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381596|NCT00673049|P2|Participant Flow|Erlotinib (Randomized to and Treated With)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381597|NCT00673049|P1|Participant Flow|Figitumumab + Erlotinib (Randomized to and Treated With)|Figitumumab ( [CP-751,871], figi) was given in combination with erlotinib (erlo) in 3-week cycles. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 milligram (mg) daily at least 1 hour before or 2 hours after the ingestion of food.
381598|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381599|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381600|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381601|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381602|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381603|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381604|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381605|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381606|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381607|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381608|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381609|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381640|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381610|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381611|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381612|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381613|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381614|NCT00673049|E3|Reported Event|Erlotinib, Then Figitumumab|Figitumumab (20 mg/kg) was given as a single agent after participants had disease progression on erlotinib alone. Figitumumab was given in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
381615|NCT00673049|E2|Reported Event|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381616|NCT00673049|E1|Reported Event|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycle. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every three weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
381617|NCT00672984|B4|Baseline|Total|Total of all reporting groups
381618|NCT00672984|B3|Baseline|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
381619|NCT00672984|B2|Baseline|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
381620|NCT00672984|B1|Baseline|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
381621|NCT00672984|P3|Participant Flow|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
381622|NCT00672984|P2|Participant Flow|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
381623|NCT00672984|P1|Participant Flow|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
381624|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381625|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381626|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381627|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381628|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381629|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381630|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381631|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381632|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381633|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381634|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381635|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381636|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381637|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381638|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381639|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381641|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381642|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381643|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381644|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381645|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381646|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381647|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381648|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381649|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381650|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381651|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381652|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381653|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381654|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381655|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381656|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381657|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381658|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381659|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381660|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381661|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381662|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381663|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
381664|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
381665|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
381666|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
381667|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
381668|NCT00672984|E3|Reported Event|Placebo|
381669|NCT00672984|E2|Reported Event|Moxifloxacin|Avelox, positive control
381670|NCT00672984|E1|Reported Event|Guanfacine|Immediate-release Guanfacine HCl
381671|NCT00672958|B3|Baseline|Total|Total of all reporting groups
381672|NCT00672958|B2|Baseline|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381673|NCT00672958|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381674|NCT00672958|P2|Participant Flow|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381675|NCT00672958|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381676|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381677|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381678|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381679|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381680|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381681|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381682|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381683|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381684|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381685|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381686|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381687|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381688|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381689|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381690|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381691|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381692|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381693|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381694|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381695|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381696|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381697|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381698|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381699|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381700|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381701|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381702|NCT00672958|E2|Reported Event|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
381703|NCT00672958|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
381704|NCT00672932|B3|Baseline|Total|Total of all reporting groups
381705|NCT00672932|B2|Baseline|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
381745|NCT00672646|P1|Participant Flow|AZD1386|AZD1386 95 mg oral solution
381706|NCT00672932|B1|Baseline|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
381707|NCT00672932|P2|Participant Flow|No Augmented Treatment Then Optional Rollover|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
381708|NCT00672932|P1|Participant Flow|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
381709|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
381710|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
381711|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
381712|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
381713|NCT00672932|E2|Reported Event|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
381714|NCT00672932|E1|Reported Event|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
381715|NCT00672854|B3|Baseline|Total|Total of all reporting groups
381716|NCT00672854|B2|Baseline|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
381717|NCT00672854|B1|Baseline|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
381718|NCT00672854|P2|Participant Flow|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
381719|NCT00672854|P1|Participant Flow|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
381720|NCT00672854|O2|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
381721|NCT00672854|O1|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
381722|NCT00672854|E2|Reported Event|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
381723|NCT00672854|E1|Reported Event|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
381724|NCT00672841|B3|Baseline|Total|Total of all reporting groups
381725|NCT00672841|B2|Baseline|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381726|NCT00672841|B1|Baseline|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381727|NCT00672841|P2|Participant Flow|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy (i.e., intravenous anidulafungin 200mg on day one, then 100mg daily x 14 days) initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381728|NCT00672841|P1|Participant Flow|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381729|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381730|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381731|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan (BDG) test for the presumptive early treatment of invasive candidiasis
381732|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381733|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381734|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381735|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381736|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381737|NCT00672841|E2|Reported Event|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
381738|NCT00672841|E1|Reported Event|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
381739|NCT00672646|B4|Baseline|Total|Total of all reporting groups
381740|NCT00672646|B3|Baseline|Placebo|AZD1386 Placebo oral solution
381741|NCT00672646|B2|Baseline|Naproxen|Naproxen 500 mg capsule
381742|NCT00672646|B1|Baseline|AZD1386|AZD1386 95 mg oral solution
381743|NCT00672646|P3|Participant Flow|Placebo|AZD1386 Placebo oral solution
381744|NCT00672646|P2|Participant Flow|Naproxen|Naproxen 500 mg capsule
381746|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381747|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381748|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381749|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381750|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381751|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381752|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381753|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381754|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381755|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381756|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381757|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381758|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381759|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381760|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381761|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
381762|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
381763|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
381764|NCT00672646|E3|Reported Event|Placebo|AZD1386 Placebo oral solution
381765|NCT00672646|E2|Reported Event|Naproxen|Naproxen 500 mg capsule
381766|NCT00672646|E1|Reported Event|AZD1386|AZD1386 95 mg oral solution
381767|NCT00672633|B3|Baseline|Total|Total of all reporting groups
381768|NCT00672633|B2|Baseline|Placebo|Corn oil placebo
381769|NCT00672633|B1|Baseline|Lovaza|Treatment Arm
381770|NCT00672633|P2|Participant Flow|Placebo|Corn oil placebo: 4 pills/day orally for 6 months
381771|NCT00672633|P1|Participant Flow|Lovaza|Treatment Arm: 4 grams/day orally for 6 months
381772|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
381773|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
381774|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
381775|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
381776|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
381777|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
381778|NCT00672633|E2|Reported Event|Placebo|Corn oil placebo
381779|NCT00672633|E1|Reported Event|Lovaza|Treatment Arm
381780|NCT00672620|B5|Baseline|Total|Total of all reporting groups
381781|NCT00672620|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381782|NCT00672620|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381783|NCT00672620|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381784|NCT00672620|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381785|NCT00672620|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
381786|NCT00672620|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381787|NCT00672620|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381788|NCT00672620|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381789|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381790|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381791|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381792|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381793|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381794|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381795|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381796|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381797|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381798|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381799|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381800|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381801|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381882|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381802|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381803|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381804|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381805|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381806|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381807|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381808|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381809|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381810|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381811|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381812|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381813|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381814|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381815|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381816|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381817|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381818|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381819|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381820|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381821|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381822|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381823|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381824|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381825|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381826|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381827|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381828|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381829|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381830|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381831|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381832|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381833|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381834|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381835|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381836|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381837|NCT00672620|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
381883|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381838|NCT00672620|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381839|NCT00672620|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
381840|NCT00672620|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
381841|NCT00672594|B1|Baseline|Treatment|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381842|NCT00672594|P1|Participant Flow|50mg Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
381843|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381844|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381845|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381846|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381847|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381848|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381849|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381850|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381851|NCT00672594|E1|Reported Event|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
381852|NCT00672555|B1|Baseline|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381853|NCT00672555|P1|Participant Flow|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381854|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381855|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381856|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381857|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381858|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381859|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381860|NCT00672555|E1|Reported Event|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
381861|NCT00672490|B3|Baseline|Total|Total of all reporting groups
381862|NCT00672490|B2|Baseline|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381863|NCT00672490|B1|Baseline|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381864|NCT00672490|P2|Participant Flow|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381865|NCT00672490|P1|Participant Flow|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381866|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381867|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381868|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381869|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381870|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381871|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381872|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381873|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381874|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381875|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381876|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381877|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381878|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381879|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381880|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381881|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381884|NCT00672490|E2|Reported Event|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
381885|NCT00672490|E1|Reported Event|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
381886|NCT00672438|B3|Baseline|Total|Total of all reporting groups
381887|NCT00672438|B2|Baseline|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil. All other procedures were identical in both groups.
381888|NCT00672438|B1|Baseline|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil prior to a saline placebo infusion. All other procedures were identical in both groups.
381889|NCT00672438|P2|Participant Flow|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil via a computer-controlled infusion pump targeting a steady-state plasma concentration of 100ng/ml. All other procedures were identical in both groups.
381890|NCT00672438|P1|Participant Flow|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil via a computer-controlled infusion targeting steady-state plasma concentration of 100ng/ml prior to a saline placebo infusion. All other procedures were identical in both groups.
381891|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381892|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381893|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381894|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381895|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381896|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381897|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381898|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381899|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381900|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381901|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381902|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381903|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381904|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381905|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381906|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381907|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381908|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381909|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
381910|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381911|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
381912|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381913|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
381914|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381915|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
381916|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381917|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
381918|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
381919|NCT00672438|E1|Reported Event|Alfentanil|Intravenous infusion of Alfentanil
381920|NCT00672256|B1|Baseline|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381921|NCT00672256|P1|Participant Flow|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381922|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381923|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381924|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381925|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381926|NCT00672256|E1|Reported Event|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
381927|NCT00672243|B1|Baseline|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381928|NCT00672243|P1|Participant Flow|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381929|NCT00672243|O1|Outcome|Tarceva and Rapamycin|
381930|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381931|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381932|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381933|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
381934|NCT00672243|E1|Reported Event|Tarceva and Rapamycin|
381935|NCT00672204|B1|Baseline|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
381936|NCT00672204|P1|Participant Flow|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
381937|NCT00672204|O1|Outcome|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
381938|NCT00672204|E1|Reported Event|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
381939|NCT00672178|B1|Baseline|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
381940|NCT00672178|P1|Participant Flow|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
381941|NCT00672178|O1|Outcome|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
381942|NCT00672178|E1|Reported Event|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
381943|NCT00672100|B4|Baseline|Total|Total of all reporting groups
381944|NCT00672100|B3|Baseline|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381945|NCT00672100|B2|Baseline|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381946|NCT00672100|B1|Baseline|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381947|NCT00672100|P3|Participant Flow|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381948|NCT00672100|P2|Participant Flow|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
382663|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
381949|NCT00672100|P1|Participant Flow|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381950|NCT00672100|O1|Outcome|All Study Participants|All study participants who received Interscalene block (ISB) using 5-20 mL of local anesthetic.
381951|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381952|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381953|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381954|NCT00672100|O3|Outcome|Ropivacaine 20 mL|
381955|NCT00672100|O2|Outcome|Ropivacaine 10 mL|
381956|NCT00672100|O1|Outcome|Ropivacaine 5 mL|
381957|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381958|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381959|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381960|NCT00672100|E3|Reported Event|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381961|NCT00672100|E2|Reported Event|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381962|NCT00672100|E1|Reported Event|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
381963|NCT00671970|B3|Baseline|Total|Total of all reporting groups
381964|NCT00671970|B2|Baseline|WHO Grade IV|WHO Grade IV Malignant Glioma
381965|NCT00671970|B1|Baseline|Who Grade III|Who Grade III Malignant Glioma
381966|NCT00671970|P2|Participant Flow|WHO Grade IV|"WHO Grade IV Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
381967|NCT00671970|P1|Participant Flow|WHO Grade III|"WHO Grade III Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
381968|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
381969|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
381970|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
381971|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
381972|NCT00671970|O2|Outcome|Negative Expression|pMAPK negative expression
381973|NCT00671970|O1|Outcome|Positive Expression|pMAPK positive expression
381974|NCT00671970|O2|Outcome|Negative Expression|pAKT negative expression
381975|NCT00671970|O1|Outcome|Positive Expression|pAKT positive expression
381976|NCT00671970|O2|Outcome|Loss|PTEN Loss
381977|NCT00671970|O1|Outcome|Intact|PTEN Intact
381978|NCT00671970|O2|Outcome|Negative Expression|EGFR vIII negative expression
381979|NCT00671970|O1|Outcome|Positive Expression|EGFR vIII positive expression
381980|NCT00671970|O2|Outcome|Negative Expression|EGFR negative expression
381981|NCT00671970|O1|Outcome|Positive Expression|EGFR positive expression
381982|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
381983|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
381984|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
381985|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
381986|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
381987|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
381988|NCT00671970|E1|Reported Event|All Patients|All Patients
381989|NCT00671931|B6|Baseline|Total|Total of all reporting groups
381990|NCT00671931|B5|Baseline|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381991|NCT00671931|B4|Baseline|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381992|NCT00671931|B3|Baseline|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381993|NCT00671931|B2|Baseline|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381994|NCT00671931|B1|Baseline|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381995|NCT00671931|P5|Participant Flow|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381996|NCT00671931|P4|Participant Flow|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381997|NCT00671931|P3|Participant Flow|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381998|NCT00671931|P2|Participant Flow|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
381999|NCT00671931|P1|Participant Flow|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382000|NCT00671931|O5|Outcome|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382001|NCT00671931|O4|Outcome|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382002|NCT00671931|O3|Outcome|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382003|NCT00671931|O2|Outcome|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382004|NCT00671931|O1|Outcome|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382005|NCT00671931|E5|Reported Event|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382006|NCT00671931|E4|Reported Event|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382007|NCT00671931|E3|Reported Event|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382008|NCT00671931|E2|Reported Event|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382009|NCT00671931|E1|Reported Event|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
382010|NCT00671918|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
382011|NCT00671918|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
382012|NCT00671918|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
382013|NCT00671918|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
382014|NCT00671918|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
382015|NCT00671879|B4|Baseline|Total|Total of all reporting groups
382016|NCT00671879|B3|Baseline|Placebo|Placebo treatment arm
382017|NCT00671879|B2|Baseline|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
382018|NCT00671879|B1|Baseline|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
382019|NCT00671879|P3|Participant Flow|Placebo|Placebo treatment arm
382020|NCT00671879|P2|Participant Flow|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
382021|NCT00671879|P1|Participant Flow|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
382022|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
382023|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
382024|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
382025|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
382026|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
382027|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol SR 700 mg twice daily
382028|NCT00671879|E3|Reported Event|Placebo|Placebo treatment arm
382029|NCT00671879|E2|Reported Event|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
382030|NCT00671879|E1|Reported Event|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
382031|NCT00671853|B3|Baseline|Total|Total of all reporting groups
382032|NCT00671853|B2|Baseline|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382033|NCT00671853|B1|Baseline|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382034|NCT00671853|P2|Participant Flow|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382035|NCT00671853|P1|Participant Flow|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382036|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382037|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382038|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382039|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382040|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382041|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382042|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382043|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382044|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|
382045|NCT00671853|O1|Outcome|Quetiapine XR|
382046|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382047|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382048|NCT00671853|E2|Reported Event|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382049|NCT00671853|E1|Reported Event|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
382050|NCT00671788|B1|Baseline|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382319|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382051|NCT00671788|P1|Participant Flow|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382052|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382053|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382054|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382055|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382056|NCT00671788|E1|Reported Event|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
382057|NCT00671749|B1|Baseline|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382058|NCT00671749|P1|Participant Flow|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382059|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382060|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382061|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382062|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382063|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382064|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382065|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382066|NCT00671749|E1|Reported Event|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
382067|NCT00671671|B3|Baseline|Total|Total of all reporting groups
382068|NCT00671671|B2|Baseline|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382069|NCT00671671|B1|Baseline|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382070|NCT00671671|P2|Participant Flow|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382071|NCT00671671|P1|Participant Flow|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382072|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382073|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382074|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382075|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382076|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382077|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382078|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382079|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382080|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382081|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382082|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382083|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382084|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382085|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382086|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382087|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382088|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382089|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382090|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
383500|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
382091|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382092|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382093|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382094|NCT00671671|E2|Reported Event|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
382095|NCT00671671|E1|Reported Event|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
382096|NCT00671606|B1|Baseline|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
382097|NCT00671606|P1|Participant Flow|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
382098|NCT00671606|O1|Outcome|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
382099|NCT00671606|E1|Reported Event|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
382100|NCT00671554|B1|Baseline|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
382101|NCT00671554|P1|Participant Flow|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
382102|NCT00671554|O1|Outcome|Melaxin and BCG|"Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration~Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration."
382103|NCT00671554|O1|Outcome|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
382104|NCT00671554|E1|Reported Event|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
382105|NCT00671528|B4|Baseline|Total|Total of all reporting groups
382106|NCT00671528|B3|Baseline|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382107|NCT00671528|B2|Baseline|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382108|NCT00671528|B1|Baseline|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382109|NCT00671528|P3|Participant Flow|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382110|NCT00671528|P2|Participant Flow|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382111|NCT00671528|P1|Participant Flow|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382112|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382113|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382114|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382115|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382116|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382117|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382118|NCT00671528|E3|Reported Event|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382119|NCT00671528|E2|Reported Event|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382120|NCT00671528|E1|Reported Event|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
382121|NCT00671515|B1|Baseline|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
382122|NCT00671515|P1|Participant Flow|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
382123|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
382124|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
382125|NCT00671515|E1|Reported Event|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
382126|NCT00671502|B4|Baseline|Total|Total of all reporting groups
382127|NCT00671502|B3|Baseline|Placebo Tablet|tablet placebo no experimental formulation
382128|NCT00671502|B2|Baseline|Carisoprodol 500mg Tablet|tablet experimental formulation
382129|NCT00671502|B1|Baseline|Carisoprodol 700mg|tablet experimental formulation
382130|NCT00671502|P3|Participant Flow|Placebo Tablet|tablet placebo no experimental formulation
382131|NCT00671502|P2|Participant Flow|Carisoprodol 500mg Tablet|tablet experimental formulation
382132|NCT00671502|P1|Participant Flow|Carisoprodol 700mg|tablet experimental formulation
382133|NCT00671502|O3|Outcome|Placebo Tablets|placebo tablets treatment arm
382134|NCT00671502|O2|Outcome|Carisoprodol 700mg Tablets|carisoprodol 700mg tablets treatment arm
382135|NCT00671502|O1|Outcome|Carisoprodol 500mg Tablets|carisoprodol 500mg tablets treatment arm
382136|NCT00671502|E3|Reported Event|Placebo Tablet|tablet placebo no experimental formulation
382137|NCT00671502|E2|Reported Event|Carisoprodol 500mg Tablet|tablet experimental formulation
382138|NCT00671502|E1|Reported Event|Carisoprodol 700mg|tablet experimental formulation
382139|NCT00671437|B1|Baseline|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382140|NCT00671437|P1|Participant Flow|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382141|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382142|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382143|NCT00671437|O3|Outcome|Progressive Disease by Both CT and PET/CT|
382144|NCT00671437|O2|Outcome|Disease Control by CT and Progressive Disease by PET/CT|
382145|NCT00671437|O1|Outcome|Disease Control by CT and PET/CT|
382146|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382322|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382147|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382148|NCT00671437|O4|Outcome|Total (Overall PET Response)|
382149|NCT00671437|O3|Outcome|Progressive Metabolic Disease (Overall PET Response)|
382150|NCT00671437|O2|Outcome|Stable Metabolic Disease (Overall PET Response)|
382151|NCT00671437|O1|Outcome|Partial Metabolic Response (Overall PET Response)|
382152|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382153|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382154|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382155|NCT00671437|E1|Reported Event|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
382156|NCT00671060|B3|Baseline|Total|Total of all reporting groups
382157|NCT00671060|B2|Baseline|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382158|NCT00671060|B1|Baseline|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382159|NCT00671060|P2|Participant Flow|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382160|NCT00671060|P1|Participant Flow|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382161|NCT00671060|O2|Outcome|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382162|NCT00671060|O1|Outcome|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382163|NCT00671060|E2|Reported Event|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382164|NCT00671060|E1|Reported Event|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
382165|NCT00670982|B3|Baseline|Total|Total of all reporting groups
382166|NCT00670982|B2|Baseline|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
382167|NCT00670982|B1|Baseline|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
382433|NCT00669942|B5|Baseline|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382168|NCT00670982|P2|Participant Flow|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
382169|NCT00670982|P1|Participant Flow|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
382170|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
382171|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
382172|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
382173|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
382174|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
382175|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
382176|NCT00670982|E1|Reported Event|All Study Participants|All participants received the same study treatment, so cumulative adverse events are reported here.
382177|NCT00670956|B1|Baseline|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382178|NCT00670956|P1|Participant Flow|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382179|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382180|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382181|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382182|NCT00670956|E1|Reported Event|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
382183|NCT00670930|B3|Baseline|Total|Total of all reporting groups
382184|NCT00670930|B2|Baseline|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382185|NCT00670930|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382186|NCT00670930|P2|Participant Flow|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382187|NCT00670930|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382188|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382189|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382664|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382190|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382191|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382192|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382193|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382194|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382195|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382196|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
382197|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
382198|NCT00670930|E2|Reported Event|Placebo|Placebo
382199|NCT00670930|E1|Reported Event|Omalizumab|Omalizumab
382200|NCT00670800|B3|Baseline|Total|Total of all reporting groups
382201|NCT00670800|B2|Baseline|Normal Controls|Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max
382202|NCT00670800|B1|Baseline|PCOS Affected Women - Metformin|Right handed women who don’t smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).
382320|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382321|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382203|NCT00670800|P2|Participant Flow|Women Controls Without PCOS|"Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).~Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics)."
382204|NCT00670800|P1|Participant Flow|Women Affected With PCOS - Metformin|The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.
382205|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
382206|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382207|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382208|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
382209|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382210|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382211|NCT00670800|O3|Outcome|Normal Control Women|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
382212|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382213|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382214|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
382215|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382216|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
382217|NCT00670800|E2|Reported Event|PCOS Affected Women on Metformin|Women with PCOS and insulin resistance
382218|NCT00670800|E1|Reported Event|Normal Controls|Women without PCOS
382219|NCT00670748|B5|Baseline|Total|Total of all reporting groups
382227|NCT00670748|P1|Participant Flow|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382220|NCT00670748|B4|Baseline|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382221|NCT00670748|B3|Baseline|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382222|NCT00670748|B2|Baseline|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382223|NCT00670748|B1|Baseline|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382224|NCT00670748|P4|Participant Flow|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382225|NCT00670748|P3|Participant Flow|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382226|NCT00670748|P2|Participant Flow|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382308|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382309|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382310|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382228|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382229|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382230|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382231|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382232|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382233|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382234|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382311|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382312|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382313|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382235|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382236|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382237|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382238|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382239|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382240|NCT00670748|E4|Reported Event|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
382241|NCT00670748|E3|Reported Event|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
382314|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382315|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382316|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382242|NCT00670748|E2|Reported Event|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382243|NCT00670748|E1|Reported Event|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
382244|NCT00670709|B3|Baseline|Total|Total of all reporting groups
382245|NCT00670709|B2|Baseline|Healthy Controls|Healthy control subjects
382246|NCT00670709|B1|Baseline|Huntington Disease|Subjects with mild or moderate Huntington's Disease
382247|NCT00670709|P2|Participant Flow|Healthy Controls|Healthy control subjects
382248|NCT00670709|P1|Participant Flow|Huntington Disease|Subjects with mild or moderate Huntington's Disease
382249|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
382250|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
382251|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
382252|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
382253|NCT00670709|E2|Reported Event|Healthy Controls|Healthy control subjects
382254|NCT00670709|E1|Reported Event|Huntington Disease|Subjects with mild or moderate Huntington's Disease
382255|NCT00670540|B1|Baseline|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382256|NCT00670540|P1|Participant Flow|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382257|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382258|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382259|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382260|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382261|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382262|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382263|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382264|NCT00670540|E1|Reported Event|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
382265|NCT00670462|B3|Baseline|Total|Total of all reporting groups
382266|NCT00670462|B2|Baseline|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382267|NCT00670462|B1|Baseline|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382268|NCT00670462|P2|Participant Flow|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382269|NCT00670462|P1|Participant Flow|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382665|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382270|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382271|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382272|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382273|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382274|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382275|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382276|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382277|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382278|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382317|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382434|NCT00669942|B4|Baseline|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382279|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382280|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382281|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382282|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382283|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382284|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382285|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382286|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382287|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
382288|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382318|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382289|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382290|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382291|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382292|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382293|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382294|NCT00670462|E2|Reported Event|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
382295|NCT00670462|E1|Reported Event|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
382296|NCT00670449|B5|Baseline|Total|Total of all reporting groups
382297|NCT00670449|B4|Baseline|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382298|NCT00670449|B3|Baseline|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382299|NCT00670449|B2|Baseline|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382300|NCT00670449|B1|Baseline|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382301|NCT00670449|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382302|NCT00670449|P3|Participant Flow|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382303|NCT00670449|P2|Participant Flow|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382304|NCT00670449|P1|Participant Flow|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382305|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
382306|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382307|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
383501|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
382323|NCT00670449|E4|Reported Event|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382324|NCT00670449|E3|Reported Event|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
382325|NCT00670449|E2|Reported Event|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
382326|NCT00670449|E1|Reported Event|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
382327|NCT00670306|B1|Baseline|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
382328|NCT00670306|P1|Participant Flow|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
382329|NCT00670306|O1|Outcome|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
382330|NCT00670306|E1|Reported Event|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
382331|NCT00670267|B1|Baseline|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
382332|NCT00670267|P1|Participant Flow|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
382333|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
382334|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
382335|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
382336|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
382337|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|"Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.~nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in."
382338|NCT00670267|E1|Reported Event|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
382339|NCT00670241|B4|Baseline|Total|Total of all reporting groups
382340|NCT00670241|B3|Baseline|Gel Vehicle|Gel Vehicle for up to 8 weeks
382341|NCT00670241|B2|Baseline|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382342|NCT00670241|B1|Baseline|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382343|NCT00670241|P3|Participant Flow|Gel Vehicle|Gel Vehicle for up to 8 weeks
382344|NCT00670241|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382345|NCT00670241|P1|Participant Flow|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382346|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
382347|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382348|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382349|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
382350|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382351|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382352|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
382353|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382354|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382355|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
382356|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382357|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382358|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
382359|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382360|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382361|NCT00670241|E3|Reported Event|Gel Vehicle|Gel Vehicle for up to 8 weeks
382362|NCT00670241|E2|Reported Event|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
382363|NCT00670241|E1|Reported Event|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
382364|NCT00670228|B3|Baseline|Total|Total of all reporting groups
382365|NCT00670228|B2|Baseline|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382366|NCT00670228|B1|Baseline|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382367|NCT00670228|P2|Participant Flow|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382368|NCT00670228|P1|Participant Flow|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382369|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382370|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382371|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382372|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382373|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382374|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382375|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382376|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382377|NCT00670228|E2|Reported Event|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
382378|NCT00670228|E1|Reported Event|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
382379|NCT00670007|B1|Baseline|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
382380|NCT00670007|P1|Participant Flow|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
382381|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382382|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382383|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382384|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382385|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382386|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382387|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382388|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382389|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382390|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382391|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382392|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382393|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382394|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382395|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382396|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382397|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382398|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382435|NCT00669942|B3|Baseline|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
383502|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
382399|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382400|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382401|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
382402|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
382403|NCT00670007|E1|Reported Event|Zemaira®|The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
382404|NCT00669955|B3|Baseline|Total|Total of all reporting groups
382405|NCT00669955|B2|Baseline|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382406|NCT00669955|B1|Baseline|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382407|NCT00669955|P2|Participant Flow|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382408|NCT00669955|P1|Participant Flow|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382409|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382410|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382411|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382412|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382413|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382414|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382415|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382416|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382417|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382418|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382419|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382420|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382421|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382422|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382423|NCT00669955|E2|Reported Event|Triple Therapy (OAC) 7 Days|Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
382424|NCT00669955|E1|Reported Event|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
382425|NCT00669942|B13|Baseline|Total|Total of all reporting groups
382426|NCT00669942|B12|Baseline|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382427|NCT00669942|B11|Baseline|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
382428|NCT00669942|B10|Baseline|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382429|NCT00669942|B9|Baseline|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382430|NCT00669942|B8|Baseline|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382431|NCT00669942|B7|Baseline|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382432|NCT00669942|B6|Baseline|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382436|NCT00669942|B2|Baseline|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382437|NCT00669942|B1|Baseline|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382438|NCT00669942|P12|Participant Flow|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382439|NCT00669942|P11|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
382440|NCT00669942|P10|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382441|NCT00669942|P9|Participant Flow|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382442|NCT00669942|P8|Participant Flow|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382443|NCT00669942|P7|Participant Flow|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382444|NCT00669942|P6|Participant Flow|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382445|NCT00669942|P5|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382446|NCT00669942|P4|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382447|NCT00669942|P3|Participant Flow|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382448|NCT00669942|P2|Participant Flow|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382449|NCT00669942|P1|Participant Flow|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382450|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382451|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382452|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382453|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382454|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382455|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382456|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382457|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382458|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382459|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382460|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382461|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382462|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382463|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382464|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382465|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382466|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382467|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382468|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382469|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382470|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382471|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382472|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382473|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382525|NCT00669916|E2|Reported Event|Placebo|Placebo was administered intravenously as a single dose.
382474|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382475|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382476|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382477|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382478|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382479|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382480|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382481|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382482|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382483|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382484|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382485|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382486|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382487|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382488|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382489|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382490|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382491|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382492|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382493|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382494|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382495|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382496|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382497|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382498|NCT00669942|E12|Reported Event|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
382499|NCT00669942|E11|Reported Event|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382500|NCT00669942|E10|Reported Event|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382501|NCT00669942|E9|Reported Event|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382502|NCT00669942|E8|Reported Event|Parts 2 and 3 - AIN457 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382503|NCT00669942|E7|Reported Event|Parts 2 and 3 - AIN457 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382504|NCT00669942|E6|Reported Event|Parts 2 and 3 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
382505|NCT00669942|E5|Reported Event|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
382506|NCT00669942|E4|Reported Event|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
382507|NCT00669942|E3|Reported Event|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
382508|NCT00669942|E2|Reported Event|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
382509|NCT00669942|E1|Reported Event|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
382510|NCT00669916|B3|Baseline|Total|Total of all reporting groups
382511|NCT00669916|B2|Baseline|Placebo|Placebo was administered intravenously as a single dose.
382512|NCT00669916|B1|Baseline|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382513|NCT00669916|P2|Participant Flow|Placebo|Placebo was administered intravenously as a single dose.
382514|NCT00669916|P1|Participant Flow|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382515|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382516|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
382517|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382518|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382519|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382520|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382521|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382522|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
382523|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
382524|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
383503|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
382526|NCT00669916|E1|Reported Event|AIN457A|AIN457A 3mg/kg was administered intravenously as a single dose.
382527|NCT00669903|B5|Baseline|Total|Total of all reporting groups
382528|NCT00669903|B4|Baseline|Placebo|Placebo
382529|NCT00669903|B3|Baseline|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382530|NCT00669903|B2|Baseline|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382531|NCT00669903|B1|Baseline|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382532|NCT00669903|P4|Participant Flow|Placebo|Placebo
382533|NCT00669903|P3|Participant Flow|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382534|NCT00669903|P2|Participant Flow|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382535|NCT00669903|P1|Participant Flow|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382536|NCT00669903|O4|Outcome|Placebo|Placebo
382537|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382538|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382539|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382540|NCT00669903|O4|Outcome|Placebo|Placebo
382541|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382542|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382543|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382544|NCT00669903|O4|Outcome|Placebo|Placebo
382545|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382546|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382547|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382548|NCT00669903|O4|Outcome|Placebo|Placebo
382549|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382550|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382551|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382552|NCT00669903|O4|Outcome|Placebo|Placebo
382553|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382554|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382555|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382556|NCT00669903|O4|Outcome|Placebo|Placebo
382557|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382558|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382559|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382560|NCT00669903|E4|Reported Event|Placebo|Placebo
382561|NCT00669903|E3|Reported Event|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
382562|NCT00669903|E2|Reported Event|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
382563|NCT00669903|E1|Reported Event|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
382564|NCT00669864|B1|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382565|NCT00669864|P1|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382566|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382567|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382568|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382569|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382570|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382571|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382572|NCT00669864|E1|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
382573|NCT00669682|B1|Baseline|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
382574|NCT00669682|P1|Participant Flow|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
382575|NCT00669682|O2|Outcome|Negative Optivol Status|These patients have transthoracic impedance measurements that do not suggest fluid overload
382576|NCT00669682|O1|Outcome|Positive Optivol Status|These patients have transthoracic impedance measurements that suggest fluid overload
382666|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382577|NCT00669682|E1|Reported Event|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
382578|NCT00669617|B1|Baseline|Total Population|Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
382579|NCT00669617|P5|Participant Flow|Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382580|NCT00669617|P4|Participant Flow|Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382581|NCT00669617|P3|Participant Flow|Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382582|NCT00669617|P2|Participant Flow|Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382583|NCT00669617|P1|Participant Flow|Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382584|NCT00669617|O5|Outcome|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382585|NCT00669617|O4|Outcome|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382586|NCT00669617|O3|Outcome|Placebo|Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382587|NCT00669617|O2|Outcome|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382588|NCT00669617|O1|Outcome|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382611|NCT00669552|P1|Participant Flow|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
383504|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
382589|NCT00669617|E5|Reported Event|Placebo|Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382590|NCT00669617|E4|Reported Event|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382591|NCT00669617|E3|Reported Event|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382592|NCT00669617|E2|Reported Event|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382593|NCT00669617|E1|Reported Event|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
382594|NCT00669578|B3|Baseline|Total|Total of all reporting groups
382595|NCT00669578|B2|Baseline|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382596|NCT00669578|B1|Baseline|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382597|NCT00669578|P2|Participant Flow|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382598|NCT00669578|P1|Participant Flow|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382599|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382600|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382601|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382602|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382603|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382604|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382605|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382606|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382607|NCT00669578|O2|Outcome|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382608|NCT00669578|O1|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
382609|NCT00669578|E1|Reported Event|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
382610|NCT00669552|B1|Baseline|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
382662|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382612|NCT00669552|O1|Outcome|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
382613|NCT00669552|E1|Reported Event|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
382614|NCT00669539|B3|Baseline|Total|Total of all reporting groups
382615|NCT00669539|B2|Baseline|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382616|NCT00669539|B1|Baseline|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382617|NCT00669539|P2|Participant Flow|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382618|NCT00669539|P1|Participant Flow|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382619|NCT00669539|O2|Outcome|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382620|NCT00669539|O1|Outcome|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382621|NCT00669539|E2|Reported Event|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382622|NCT00669539|E1|Reported Event|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
382623|NCT00669461|B1|Baseline|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
382624|NCT00669461|P1|Participant Flow|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
382625|NCT00669461|O1|Outcome|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
382626|NCT00669461|O1|Outcome|Lubiprostone|Lubiprostone 24 micrograms po BID given for total of 4 weeks
382627|NCT00669461|E1|Reported Event|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
382628|NCT00669396|B3|Baseline|Total|Total of all reporting groups
382629|NCT00669396|B2|Baseline|Levonorgestrel|Oral levonorgestrel
382630|NCT00669396|B1|Baseline|Copper T380 IUD|IUD
382631|NCT00669396|P2|Participant Flow|Levonorgestrel|Oral levonorgestrel
382632|NCT00669396|P1|Participant Flow|Copper T380 IUD|IUD
382633|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
382634|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
382635|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
382636|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
382637|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
382638|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
382639|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
382640|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
382641|NCT00669396|E2|Reported Event|Levonorgestrel|Oral levonorgestrel
382642|NCT00669396|E1|Reported Event|Copper T380 IUD|IUD
382643|NCT00669331|B3|Baseline|Total|Total of all reporting groups
382644|NCT00669331|B2|Baseline|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382645|NCT00669331|B1|Baseline|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382646|NCT00669331|P2|Participant Flow|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382647|NCT00669331|P1|Participant Flow|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382648|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382649|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382650|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382651|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382652|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382653|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382654|NCT00669331|O2|Outcome|Control|"Matched control - inhaled mannitol 50mg~Matched control: 50mg dose of Mannitol BD for 52 weeks"
382655|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol 400mg~Inhaled mannitol: 400mg dose of Mannitol BD for 52 weeks"
382656|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382657|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382658|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382659|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382660|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382661|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
383505|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
382667|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382668|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382669|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382670|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382671|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382672|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382673|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382674|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382675|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382676|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382677|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382678|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382679|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382680|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382681|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382682|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382683|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382684|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382685|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382686|NCT00669331|E2|Reported Event|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
382687|NCT00669331|E1|Reported Event|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
382688|NCT00669318|B1|Baseline|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382689|NCT00669318|P1|Participant Flow|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382690|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382691|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382692|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382711|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382693|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382694|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
382695|NCT00669318|E1|Reported Event|Treatment (Pentostatin, Alemtuzumab, Rituximab)|sargramostim
382696|NCT00669279|B3|Baseline|Total|Total of all reporting groups
382697|NCT00669279|B2|Baseline|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
382698|NCT00669279|B1|Baseline|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
382699|NCT00669279|P2|Participant Flow|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
382700|NCT00669279|P1|Participant Flow|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
382701|NCT00669279|O2|Outcome|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
382702|NCT00669279|O1|Outcome|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
382703|NCT00669279|E2|Reported Event|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
382704|NCT00669279|E1|Reported Event|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
382705|NCT00669240|B1|Baseline|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382706|NCT00669240|P1|Participant Flow|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382707|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382708|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382709|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382710|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382728|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382712|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382713|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382714|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382715|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382716|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382717|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382718|NCT00669240|E1|Reported Event|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
382719|NCT00669214|B3|Baseline|Total|Total of all reporting groups
382720|NCT00669214|B2|Baseline|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382721|NCT00669214|B1|Baseline|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382722|NCT00669214|P2|Participant Flow|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382723|NCT00669214|P1|Participant Flow|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382724|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382725|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382726|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382727|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382885|NCT00668746|B2|Baseline|No Drug Intervention|A control consisting of no drug intervention
383506|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
382729|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382730|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382731|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382732|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382733|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382734|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382735|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382736|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382737|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382738|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382739|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382740|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382741|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382742|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382743|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382744|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382745|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382746|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382747|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382748|NCT00669214|E6|Reported Event|Efalizumab: Follow-Up Period|
382749|NCT00669214|E5|Reported Event|Placebo: Follow-Up Period|
382750|NCT00669214|E4|Reported Event|Efalizumab: Open-Label Period|
382751|NCT00669214|E3|Reported Event|Placebo: Open-Label Period|
382752|NCT00669214|E2|Reported Event|Efalizumab: Double-Blind Period|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382919|NCT00668525|B4|Baseline|Total|Total of all reporting groups
382753|NCT00669214|E1|Reported Event|Placebo: Double-Blind Period|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
382754|NCT00669110|B3|Baseline|Total|Total of all reporting groups
382755|NCT00669110|B2|Baseline|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382756|NCT00669110|B1|Baseline|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382757|NCT00669110|P2|Participant Flow|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382758|NCT00669110|P1|Participant Flow|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382759|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382760|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382761|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382762|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382763|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382764|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382765|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382766|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382767|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382768|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382769|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382770|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382771|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382772|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382773|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382774|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382775|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382776|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382777|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382778|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382779|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382780|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382781|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382782|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382783|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382784|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382785|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382786|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382787|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382788|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382789|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
382790|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382791|NCT00669110|E2|Reported Event|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
383507|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
382792|NCT00669110|E1|Reported Event|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
382793|NCT00669071|B1|Baseline|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
382794|NCT00669071|P1|Participant Flow|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
382795|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382796|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382797|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382798|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382799|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382800|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382801|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382802|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382803|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382804|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382805|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382806|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382807|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382808|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382809|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
382810|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
382811|NCT00669071|E1|Reported Event|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
382812|NCT00669032|B3|Baseline|Total|Total of all reporting groups
382813|NCT00669032|B2|Baseline|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382814|NCT00669032|B1|Baseline|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382815|NCT00669032|P2|Participant Flow|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382816|NCT00669032|P1|Participant Flow|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382817|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382818|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382819|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382820|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382821|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382822|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382823|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382824|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382825|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382826|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382827|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382828|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382829|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382830|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382831|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382832|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382833|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382834|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382835|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382836|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382837|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382838|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382839|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382840|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382841|NCT00669032|E2|Reported Event|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382842|NCT00669032|E1|Reported Event|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
382843|NCT00669019|B1|Baseline|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
382844|NCT00669019|P1|Participant Flow|Saracatinib|Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
382845|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
382846|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
382847|NCT00669019|E1|Reported Event|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
382848|NCT00668902|B4|Baseline|Total|Total of all reporting groups
382849|NCT00668902|B3|Baseline|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382850|NCT00668902|B2|Baseline|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382851|NCT00668902|B1|Baseline|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382852|NCT00668902|P3|Participant Flow|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382853|NCT00668902|P2|Participant Flow|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382854|NCT00668902|P1|Participant Flow|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382855|NCT00668902|O3|Outcome|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382856|NCT00668902|O2|Outcome|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382857|NCT00668902|O1|Outcome|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382858|NCT00668902|E3|Reported Event|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382859|NCT00668902|E2|Reported Event|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382860|NCT00668902|E1|Reported Event|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
382861|NCT00668863|B1|Baseline|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382862|NCT00668863|P1|Participant Flow|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382863|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382864|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382865|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382866|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382867|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382868|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382981|NCT00668265|E1|Reported Event|Quetiapine|Active treatment arm for subjects on MMTP in Su Casa residence
383508|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
382869|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382870|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382871|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382872|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382873|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382874|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382875|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382876|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382877|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382878|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382879|NCT00668863|E1|Reported Event|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
382880|NCT00668785|B1|Baseline|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
382881|NCT00668785|P1|Participant Flow|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
382882|NCT00668785|O1|Outcome|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
382883|NCT00668785|E1|Reported Event|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
382884|NCT00668746|B3|Baseline|Total|Total of all reporting groups
382886|NCT00668746|B1|Baseline|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
382887|NCT00668746|P2|Participant Flow|No Drug Intervention|A control consisting of no drug intervention
382888|NCT00668746|P1|Participant Flow|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
382889|NCT00668746|O6|Outcome|Control Group at Day 180|
382890|NCT00668746|O5|Outcome|Control Group at Day 30|
382891|NCT00668746|O4|Outcome|Control Group at Baseline|
382892|NCT00668746|O3|Outcome|Minocycline Group at Day 180|
382893|NCT00668746|O2|Outcome|Minocycline Group at Day 30|
382894|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
382895|NCT00668746|O6|Outcome|Control Group at 180 Days|
382896|NCT00668746|O5|Outcome|Control Group at 30 Days|
382897|NCT00668746|O4|Outcome|Control Group at Baseline|
382898|NCT00668746|O3|Outcome|Micocycline Group at 180 Days|
382899|NCT00668746|O2|Outcome|Minocycline Group at 30 Days|
382900|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
382901|NCT00668746|O2|Outcome|No Drug Intervention|A control consisting of no drug intervention
382902|NCT00668746|O1|Outcome|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
382903|NCT00668746|E2|Reported Event|No Drug Intervention|A control consisting of no drug intervention
382904|NCT00668746|E1|Reported Event|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
382905|NCT00668733|B3|Baseline|Total|Total of all reporting groups
382906|NCT00668733|B2|Baseline|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382907|NCT00668733|B1|Baseline|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382908|NCT00668733|P2|Participant Flow|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382909|NCT00668733|P1|Participant Flow|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382910|NCT00668733|O2|Outcome|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382911|NCT00668733|O1|Outcome|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382912|NCT00668733|E2|Reported Event|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382913|NCT00668733|E1|Reported Event|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
382914|NCT00668564|B1|Baseline|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
382915|NCT00668564|P1|Participant Flow|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
382916|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
382917|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
382918|NCT00668564|E1|Reported Event|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
382920|NCT00668525|B3|Baseline|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382921|NCT00668525|B2|Baseline|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382922|NCT00668525|B1|Baseline|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382923|NCT00668525|P3|Participant Flow|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382924|NCT00668525|P2|Participant Flow|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382925|NCT00668525|P1|Participant Flow|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382926|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382927|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382928|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382929|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382930|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382931|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382932|NCT00668525|E3|Reported Event|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382933|NCT00668525|E2|Reported Event|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382934|NCT00668525|E1|Reported Event|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
382935|NCT00668434|B3|Baseline|Total|Total of all reporting groups
382936|NCT00668434|B2|Baseline|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382937|NCT00668434|B1|Baseline|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382938|NCT00668434|P2|Participant Flow|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382939|NCT00668434|P1|Participant Flow|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382940|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382941|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382942|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382943|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382944|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382945|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382946|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382947|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382948|NCT00668434|E2|Reported Event|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
382949|NCT00668434|E1|Reported Event|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
382950|NCT00668395|B4|Baseline|Total|Total of all reporting groups
382951|NCT00668395|B3|Baseline|CYP2B6*6/*6|Slow metabolizer
382952|NCT00668395|B2|Baseline|CYP2B6*1/*6|Intermediate metabolizer
382953|NCT00668395|B1|Baseline|CYP2B6*1/*1|Normal metabolizer
382954|NCT00668395|P3|Participant Flow|CYP2B6*6/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
382955|NCT00668395|P2|Participant Flow|CYP2B6*1/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
382956|NCT00668395|P1|Participant Flow|CYP2B6*1/*1 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
382957|NCT00668395|O3|Outcome|CYP2B6*6/*6|Slow metabolizer
382958|NCT00668395|O2|Outcome|CYP2B6*1/*6|Intermediate metabolizer
382959|NCT00668395|O1|Outcome|CYP2B6*1/*1|Normal metabolizer
382960|NCT00668395|E3|Reported Event|CYP2B6*6/*6|Slow metabolizer
382961|NCT00668395|E2|Reported Event|CYP2B6*1/*6|Intermediate metabolizer
382962|NCT00668395|E1|Reported Event|CYP2B6*1/*1|Normal metabolizer
382963|NCT00668382|B1|Baseline|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
382964|NCT00668382|P1|Participant Flow|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
382965|NCT00668382|O1|Outcome|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
382966|NCT00668382|E1|Reported Event|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
382967|NCT00668317|B1|Baseline|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
382968|NCT00668317|P1|Participant Flow|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
382969|NCT00668317|O1|Outcome|Omeprazole and Ranitidine|Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
382970|NCT00668317|E1|Reported Event|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
382971|NCT00668265|B3|Baseline|Total|Total of all reporting groups
382972|NCT00668265|B2|Baseline|Placebo|Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
382973|NCT00668265|B1|Baseline|Quetiapine|Subjects on MMTP receiving quetiapine
382974|NCT00668265|P2|Participant Flow|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
382975|NCT00668265|P1|Participant Flow|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
382976|NCT00668265|O2|Outcome|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
382977|NCT00668265|O1|Outcome|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
382978|NCT00668265|O2|Outcome|Placebo|
382979|NCT00668265|O1|Outcome|Quetiapine|
382980|NCT00668265|E2|Reported Event|Placebo|Placebo arm for subjects on MMTP in Su Casa Residence
382982|NCT00668200|B1|Baseline|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382983|NCT00668200|P1|Participant Flow|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382984|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382985|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382986|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382987|NCT00668200|E1|Reported Event|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
382988|NCT00667992|B3|Baseline|Total|Total of all reporting groups
382989|NCT00667992|B2|Baseline|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
382990|NCT00667992|B1|Baseline|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
382991|NCT00667992|P2|Participant Flow|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
382992|NCT00667992|P1|Participant Flow|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
382993|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
382994|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
382995|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
382996|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
382997|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
382998|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
382999|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383000|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383001|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383002|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
383003|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383004|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383005|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383006|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383007|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383008|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383009|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383010|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383011|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383012|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
383013|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383014|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383015|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383016|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
383017|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383018|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383019|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383020|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383021|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383022|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383023|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383024|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383025|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383026|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
383027|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383028|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383029|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383030|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
383031|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383032|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
383033|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383034|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
383035|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383036|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
383037|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383038|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383039|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383040|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
383041|NCT00667992|E4|Reported Event|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
383042|NCT00667992|E3|Reported Event|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
383043|NCT00667992|E2|Reported Event|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
383044|NCT00667992|E1|Reported Event|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
383045|NCT00667875|B4|Baseline|Total|Total of all reporting groups
383046|NCT00667875|B3|Baseline|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
383047|NCT00667875|B2|Baseline|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
383048|NCT00667875|B1|Baseline|1 Placebo|Placebo : placebo
383049|NCT00667875|P3|Participant Flow|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
383050|NCT00667875|P2|Participant Flow|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
383051|NCT00667875|P1|Participant Flow|1 Placebo|Placebo : placebo
383052|NCT00667875|O3|Outcome|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
383053|NCT00667875|O2|Outcome|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
383054|NCT00667875|O1|Outcome|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
383055|NCT00667875|E3|Reported Event|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
383056|NCT00667875|E2|Reported Event|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
383057|NCT00667875|E1|Reported Event|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
383058|NCT00667849|B3|Baseline|Total|Total of all reporting groups
383059|NCT00667849|B2|Baseline|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound).~Sham: sham device identical to active device with the exception of administration of ultrasound"
383060|NCT00667849|B1|Baseline|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
383061|NCT00667849|P2|Participant Flow|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: sham device identical to active device with the exception of administration of ultrasound"
383062|NCT00667849|P1|Participant Flow|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
383063|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~sham: sham device identical to active device with the exception of administration of ultrasound"
383064|NCT00667849|O1|Outcome|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
383065|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
383066|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
383067|NCT00667849|O2|Outcome|Sham|Single arm, sham (identical to active device with the exception of administration of ultrasound)
383068|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
383069|NCT00667849|E2|Reported Event|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
383070|NCT00667849|E1|Reported Event|Exogen 4000+|"Single arm, active Exogen 4000+ ultrasound bone healing system~Low-intensity pulsed ultrasound (LIPUS)"
383071|NCT00667810|B5|Baseline|Total|Total of all reporting groups
383072|NCT00667810|B4|Baseline|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383073|NCT00667810|B3|Baseline|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383074|NCT00667810|B2|Baseline|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383146|NCT00667732|B3|Baseline|Total|Total of all reporting groups
383075|NCT00667810|B1|Baseline|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383076|NCT00667810|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383077|NCT00667810|P3|Participant Flow|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383078|NCT00667810|P2|Participant Flow|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383079|NCT00667810|P1|Participant Flow|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383080|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383081|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383082|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383083|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383084|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383085|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383086|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383087|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383088|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383089|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383090|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383091|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383092|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383093|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383094|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383095|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383096|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383097|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383098|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383099|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383100|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383101|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383182|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383102|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383103|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383104|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383105|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383106|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383107|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383108|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383109|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383110|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the DAD total score, results are presented from a REML)-based MMRM.
383111|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the DAD total score, results are presented from a REML-based MMRM.
383112|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
383113|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
383114|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383115|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383116|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383117|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
383118|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383119|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383120|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383121|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
383122|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383123|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383124|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383125|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383126|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383127|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383128|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383129|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383130|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383131|NCT00667810|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383132|NCT00667810|E3|Reported Event|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383133|NCT00667810|E2|Reported Event|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383134|NCT00667810|E1|Reported Event|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
383135|NCT00667745|B3|Baseline|Total|Total of all reporting groups
383136|NCT00667745|B2|Baseline|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383137|NCT00667745|B1|Baseline|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383138|NCT00667745|P2|Participant Flow|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383139|NCT00667745|P1|Participant Flow|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383140|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383141|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383142|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383143|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383144|NCT00667745|E2|Reported Event|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383145|NCT00667745|E1|Reported Event|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
383147|NCT00667732|B2|Baseline|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
383148|NCT00667732|B1|Baseline|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
383149|NCT00667732|P3|Participant Flow|Placebo Group|"After run-in participants were randomized to placebo.~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide instead of placebo"
383150|NCT00667732|P2|Participant Flow|Exenatide Group|"After run-in participants were randomized to exenatide.~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide"
383151|NCT00667732|P1|Participant Flow|Run-In Group|"All participants took exenatide twice daily in addition to their Metformin dose.~A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time."
383152|NCT00667732|O2|Outcome|Placebo Group|
383153|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
383154|NCT00667732|O2|Outcome|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
383155|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
383156|NCT00667732|E5|Reported Event|Exenatide Open-Label (Previous Placebo)|Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
383157|NCT00667732|E4|Reported Event|Exenatide Open-Label (Previous Exenatide)|Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
383158|NCT00667732|E3|Reported Event|Placebo Randomization Period|After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
383159|NCT00667732|E2|Reported Event|Exenatide Randomization Group|After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
383160|NCT00667732|E1|Reported Event|Run-In Group|All participants took exenatide twice daily in addition to their Metformin dose.
383161|NCT00667693|B3|Baseline|Total|Total of all reporting groups
383162|NCT00667693|B2|Baseline|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
383163|NCT00667693|B1|Baseline|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
383164|NCT00667693|P2|Participant Flow|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
383165|NCT00667693|P1|Participant Flow|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
383166|NCT00667693|O2|Outcome|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
383167|NCT00667693|O1|Outcome|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
383168|NCT00667693|E2|Reported Event|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
383169|NCT00667693|E1|Reported Event|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
383170|NCT00667602|B4|Baseline|Total|Total of all reporting groups
383171|NCT00667602|B3|Baseline|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383172|NCT00667602|B2|Baseline|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383173|NCT00667602|B1|Baseline|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383174|NCT00667602|P3|Participant Flow|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383175|NCT00667602|P2|Participant Flow|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383176|NCT00667602|P1|Participant Flow|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383177|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383178|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383179|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383180|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383181|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383330|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383183|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383184|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383185|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383186|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383187|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383188|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383189|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383190|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383191|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383192|NCT00667602|O3|Outcome|MenC(1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383193|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383194|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383195|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383196|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383197|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383198|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383199|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383200|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383201|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383202|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383203|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383204|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.
383205|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383206|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383207|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383208|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383209|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383210|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383211|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383212|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383213|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383214|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383215|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383216|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383217|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383218|NCT00667602|E3|Reported Event|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383509|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383219|NCT00667602|E2|Reported Event|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383220|NCT00667602|E1|Reported Event|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
383221|NCT00667589|B5|Baseline|Total|Total of all reporting groups
383222|NCT00667589|B4|Baseline|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
383223|NCT00667589|B3|Baseline|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
383224|NCT00667589|B2|Baseline|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
383225|NCT00667589|B1|Baseline|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
383226|NCT00667589|P4|Participant Flow|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
383227|NCT00667589|P3|Participant Flow|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
383228|NCT00667589|P2|Participant Flow|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
383229|NCT00667589|P1|Participant Flow|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
383230|NCT00667589|O3|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
383231|NCT00667589|O2|Outcome|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
383232|NCT00667589|O1|Outcome|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
383233|NCT00667589|O1|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
383234|NCT00667589|E4|Reported Event|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
383235|NCT00667589|E3|Reported Event|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
383236|NCT00667589|E2|Reported Event|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
383237|NCT00667589|E1|Reported Event|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
383238|NCT00667576|B6|Baseline|Total|Total of all reporting groups
383239|NCT00667576|B5|Baseline|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383240|NCT00667576|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383241|NCT00667576|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383242|NCT00667576|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383243|NCT00667576|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383244|NCT00667576|P5|Participant Flow|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383245|NCT00667576|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383246|NCT00667576|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383247|NCT00667576|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383248|NCT00667576|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383249|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383250|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383251|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383252|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383253|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383254|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383255|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383256|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383257|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383258|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383259|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383260|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383261|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383262|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383263|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383264|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383265|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383266|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383267|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383268|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383269|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383270|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383271|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383272|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383273|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383274|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383275|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383276|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383277|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383278|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383279|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383280|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383281|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383282|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383283|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383284|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383285|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383286|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383287|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383288|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383289|NCT00667576|E5|Reported Event|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
383290|NCT00667576|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
383291|NCT00667576|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
383292|NCT00667576|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
383293|NCT00667576|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
383294|NCT00667563|B1|Baseline|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383295|NCT00667563|P1|Participant Flow|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383296|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383297|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383298|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383299|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383331|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383332|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383300|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383301|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383302|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383303|NCT00667563|E1|Reported Event|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
383304|NCT00667511|B1|Baseline|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period."
383305|NCT00667511|P1|Participant Flow|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.~In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out."
383306|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
383307|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
383308|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
383309|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
383310|NCT00667511|E2|Reported Event|Nocturnal Home Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
383311|NCT00667511|E1|Reported Event|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
383312|NCT00667459|B3|Baseline|Total|Total of all reporting groups
383313|NCT00667459|B2|Baseline|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383314|NCT00667459|B1|Baseline|Investigational|PRESTIGE® LP Cervical Disc
383315|NCT00667459|P2|Participant Flow|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
383316|NCT00667459|P1|Participant Flow|Investigational|PRESTIGE® LP Cervical Disc
383317|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383318|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383319|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383320|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383321|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383322|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383323|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383324|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383325|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383326|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383327|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383328|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383329|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383333|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383334|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383335|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383336|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383337|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383338|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383339|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383340|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383341|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383342|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383343|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383344|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383345|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383346|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383347|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383348|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383349|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383350|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383351|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383352|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
383353|NCT00667459|E2|Reported Event|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
383354|NCT00667459|E1|Reported Event|Investigational|PRESTIGE® LP Cervical Disc
383355|NCT00667446|B3|Baseline|Total|Total of all reporting groups
383356|NCT00667446|B2|Baseline|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383357|NCT00667446|B1|Baseline|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383358|NCT00667446|P2|Participant Flow|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
383359|NCT00667446|P1|Participant Flow|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
383360|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383361|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383362|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383363|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383364|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383365|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383366|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383367|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383368|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383369|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383370|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383371|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383372|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383373|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383374|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383375|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383376|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383377|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383378|NCT00667446|E2|Reported Event|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
383499|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383379|NCT00667446|E1|Reported Event|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
383380|NCT00667420|B1|Baseline|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
383381|NCT00667420|P1|Participant Flow|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
383382|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
383383|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
383384|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
383385|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
383386|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
383387|NCT00667420|E1|Reported Event|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
383388|NCT00667394|B3|Baseline|Total|Total of all reporting groups
383389|NCT00667394|B2|Baseline|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
383390|NCT00667394|B1|Baseline|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
383391|NCT00667394|P2|Participant Flow|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
383392|NCT00667394|P1|Participant Flow|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
383393|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
383394|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
383395|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
383396|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
383397|NCT00667394|E2|Reported Event|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
383398|NCT00667394|E1|Reported Event|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
383399|NCT00667381|B3|Baseline|Total|Total of all reporting groups
383400|NCT00667381|B2|Baseline|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383401|NCT00667381|B1|Baseline|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383402|NCT00667381|P2|Participant Flow|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383403|NCT00667381|P1|Participant Flow|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383404|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383405|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383406|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383407|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383408|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383409|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383410|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383411|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383412|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383413|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383414|NCT00667381|E2|Reported Event|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
383415|NCT00667381|E1|Reported Event|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
383416|NCT00667368|B3|Baseline|Total|Total of all reporting groups
383417|NCT00667368|B2|Baseline|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
383418|NCT00667368|B1|Baseline|Control|Bi-monthly testing for BV without treatment.
383419|NCT00667368|P2|Participant Flow|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
383420|NCT00667368|P1|Participant Flow|Control|Bi-monthly testing for BV without treatment.
383421|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
383422|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
383423|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
383424|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
383425|NCT00667368|E2|Reported Event|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
383426|NCT00667368|E1|Reported Event|Control|Bi-monthly testing for BV without treatment.
383427|NCT00667355|B1|Baseline|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383428|NCT00667355|P1|Participant Flow|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383429|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383430|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383431|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383432|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383433|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383434|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383435|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383436|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383437|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383438|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383439|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383440|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383441|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383442|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383443|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383444|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383445|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383446|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383447|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383448|NCT00667355|E1|Reported Event|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
383449|NCT00667342|B4|Baseline|Total|Total of all reporting groups
383450|NCT00667342|B3|Baseline|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
383451|NCT00667342|B2|Baseline|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
383452|NCT00667342|B1|Baseline|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383453|NCT00667342|P3|Participant Flow|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
383454|NCT00667342|P2|Participant Flow|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
383455|NCT00667342|P1|Participant Flow|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383456|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
383457|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
383458|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
383459|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
383460|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
383461|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
383462|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
383463|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
383464|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
383465|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
383466|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
383467|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
383468|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
383469|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
383470|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
383471|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383472|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383473|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants were included in this analysis
383474|NCT00667342|O1|Outcome|All Participants|All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
383475|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
383476|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383477|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
383478|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383479|NCT00667342|E2|Reported Event|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
383480|NCT00667342|E1|Reported Event|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
383481|NCT00667277|B1|Baseline|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
383482|NCT00667277|P1|Participant Flow|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
383483|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
383484|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
383485|NCT00667277|E1|Reported Event|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
383486|NCT00667251|B3|Baseline|Total|Total of all reporting groups
383487|NCT00667251|B2|Baseline|Trastuzumab|
383488|NCT00667251|B1|Baseline|Lapatinib|
383489|NCT00667251|P2|Participant Flow|Trastuzumab|"Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle)~Followed by:~Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression."
383490|NCT00667251|P1|Participant Flow|Lapatinib|"Lapatinib - 1250 mg po daily~Taxane based chemotherapy:~Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or~Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards.~Followed by:~Lapatinib - 1500 mg po daily until disease progression."
383491|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383492|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
383493|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383494|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
383495|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383496|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
383497|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
383498|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
383510|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
383511|NCT00667251|E2|Reported Event|Trastuzumab|Plus taxane based chemotherapy.
383512|NCT00667251|E1|Reported Event|Lapatinib|Plus taxane based chemotherapy
383513|NCT00667225|B3|Baseline|Total|Total of all reporting groups
383514|NCT00667225|B2|Baseline|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383515|NCT00667225|B1|Baseline|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383516|NCT00667225|P2|Participant Flow|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383517|NCT00667225|P1|Participant Flow|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383518|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383519|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383520|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383521|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383522|NCT00667225|E2|Reported Event|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383523|NCT00667225|E1|Reported Event|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
383524|NCT00667186|B3|Baseline|Total|Total of all reporting groups
383525|NCT00667186|B2|Baseline|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383526|NCT00667186|B1|Baseline|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383527|NCT00667186|P2|Participant Flow|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383528|NCT00667186|P1|Participant Flow|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383529|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
384148|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
383530|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383531|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383532|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383533|NCT00667186|E2|Reported Event|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383534|NCT00667186|E1|Reported Event|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
383535|NCT00667095|B3|Baseline|Total|Total of all reporting groups
383536|NCT00667095|B2|Baseline|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383537|NCT00667095|B1|Baseline|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383538|NCT00667095|P2|Participant Flow|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383539|NCT00667095|P1|Participant Flow|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383540|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383541|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383542|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383543|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383544|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383545|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383546|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383547|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383548|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383549|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383550|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383661|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383551|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383552|NCT00667095|E2|Reported Event|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383553|NCT00667095|E1|Reported Event|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
383554|NCT00666965|B5|Baseline|Total|Total of all reporting groups
383555|NCT00666965|B4|Baseline|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383556|NCT00666965|B3|Baseline|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383557|NCT00666965|B2|Baseline|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383558|NCT00666965|B1|Baseline|Placebo|placebo transdermal patch
383559|NCT00666965|P4|Participant Flow|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383560|NCT00666965|P3|Participant Flow|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383561|NCT00666965|P2|Participant Flow|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383562|NCT00666965|P1|Participant Flow|Placebo|placebo transdermal patch
383563|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383564|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383565|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383566|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383567|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383568|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383569|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383570|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383571|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383572|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383573|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383574|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383575|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383576|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383577|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383578|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383579|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383580|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383581|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383582|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383583|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383584|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383585|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383586|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
383587|NCT00666965|E4|Reported Event|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
383588|NCT00666965|E3|Reported Event|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
383589|NCT00666965|E2|Reported Event|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
383590|NCT00666965|E1|Reported Event|Placebo|placebo transdermal patch
383591|NCT00666926|B1|Baseline|Entire Study Population|PF-00562271 dose escalation administered as 5 mg PO BID up to 150 mg PO BID or 125 mg PO QD up to 225 mg PO QD. Participants in the PF-00562271125 mg BID US E1 cohort administered MDZ 2 mg/mL as a single dose on C1.D1 and C1.D21 prior to PF-00562271 dosing.
383592|NCT00666926|P16|Participant Flow|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383593|NCT00666926|P15|Participant Flow|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383594|NCT00666926|P14|Participant Flow|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383595|NCT00666926|P13|Participant Flow|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383596|NCT00666926|P12|Participant Flow|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 (C1.D21) simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
383597|NCT00666926|P11|Participant Flow|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383598|NCT00666926|P10|Participant Flow|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
383599|NCT00666926|P9|Participant Flow|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383600|NCT00666926|P8|Participant Flow|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
383601|NCT00666926|P7|Participant Flow|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383602|NCT00666926|P6|Participant Flow|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383603|NCT00666926|P5|Participant Flow|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383604|NCT00666926|P4|Participant Flow|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383605|NCT00666926|P3|Participant Flow|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383606|NCT00666926|P2|Participant Flow|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383607|NCT00666926|P1|Participant Flow|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383608|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383609|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383610|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383611|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383612|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383613|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383614|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383615|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383616|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383617|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383618|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383619|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383620|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383621|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383622|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383623|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383624|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383625|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383626|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383627|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383628|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383629|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383708|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383709|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383710|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383630|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383631|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383632|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383633|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383634|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383635|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383636|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383637|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383638|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383639|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383640|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383641|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383642|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383643|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383644|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383645|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383646|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383647|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383648|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383649|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383650|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383651|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383652|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383653|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383654|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383655|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383656|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383657|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383658|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383659|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383660|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
384149|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
383662|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383663|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383664|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383665|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383666|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383667|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383668|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383669|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383670|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383671|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383672|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383673|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383674|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383675|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383676|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383677|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383678|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383679|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383680|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383681|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383682|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383683|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383684|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383685|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383686|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383687|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383688|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383711|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383744|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383689|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383690|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383691|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383692|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383693|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383694|NCT00666926|O14|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383695|NCT00666926|O13|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383696|NCT00666926|O12|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383697|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383698|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383699|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383700|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383701|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383702|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383703|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383704|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383705|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383706|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383707|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
384150|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
383712|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383713|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383714|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383715|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383716|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383717|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383718|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383719|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383720|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383721|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383722|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383723|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383724|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383725|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383726|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383727|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383728|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383729|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383730|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383731|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383732|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383733|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383734|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383735|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383736|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383737|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383738|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383739|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383740|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383741|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383742|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383743|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383745|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383746|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383747|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383748|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383749|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383750|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383751|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383752|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383753|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383754|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383755|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383756|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383757|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383758|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383759|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383760|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383761|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383762|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383763|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383764|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383765|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383766|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383767|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383768|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383769|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383770|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383771|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383772|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383773|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383774|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383775|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383776|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383777|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383778|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383779|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383780|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383781|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383782|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383783|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383784|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383785|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383786|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383787|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383788|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383789|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383790|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383791|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383792|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383793|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383794|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383795|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383796|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383797|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383798|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383799|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383800|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383801|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383802|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383803|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383804|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383805|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383806|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383807|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383808|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383809|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383810|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383811|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383812|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383843|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383844|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383845|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383904|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
383813|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383814|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383815|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
383816|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383817|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383818|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383819|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383820|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
383821|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383822|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383823|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383824|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383825|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383826|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383827|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383828|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383829|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383830|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383831|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383832|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383833|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383834|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383835|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383836|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383837|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383838|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383839|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383840|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383841|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383842|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
384213|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
383846|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383847|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383848|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
383849|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383850|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383851|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383852|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383853|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
383854|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383855|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383856|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383857|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383858|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383859|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383860|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383861|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383862|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383863|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383864|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383865|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383866|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383867|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383868|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383869|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
383870|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383903|NCT00666848|P1|Participant Flow|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
384151|NCT00666458|E2|Reported Event|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
383871|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
383872|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383873|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
383874|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383875|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383876|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383877|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383878|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383879|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383880|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383881|NCT00666926|E16|Reported Event|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
383882|NCT00666926|E15|Reported Event|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
383883|NCT00666926|E14|Reported Event|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
383884|NCT00666926|E13|Reported Event|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
383885|NCT00666926|E12|Reported Event|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
383886|NCT00666926|E11|Reported Event|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
383887|NCT00666926|E10|Reported Event|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
383888|NCT00666926|E9|Reported Event|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
383889|NCT00666926|E8|Reported Event|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
383890|NCT00666926|E7|Reported Event|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
383891|NCT00666926|E6|Reported Event|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
383892|NCT00666926|E5|Reported Event|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
383893|NCT00666926|E4|Reported Event|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
383894|NCT00666926|E3|Reported Event|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
383895|NCT00666926|E2|Reported Event|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
383896|NCT00666926|E1|Reported Event|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
383897|NCT00666848|B4|Baseline|Total|Total of all reporting groups
383898|NCT00666848|B3|Baseline|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
383899|NCT00666848|B2|Baseline|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
383900|NCT00666848|B1|Baseline|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
383901|NCT00666848|P3|Participant Flow|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
383902|NCT00666848|P2|Participant Flow|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
383905|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
383906|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
383907|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
383908|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
383909|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
383910|NCT00666848|E3|Reported Event|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
383911|NCT00666848|E2|Reported Event|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
383912|NCT00666848|E1|Reported Event|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
383913|NCT00666757|B3|Baseline|Total|Total of all reporting groups
383914|NCT00666757|B2|Baseline|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383915|NCT00666757|B1|Baseline|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383916|NCT00666757|P2|Participant Flow|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383917|NCT00666757|P1|Participant Flow|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383918|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383919|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383920|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383921|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383922|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383923|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383924|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383925|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383926|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383927|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383928|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383929|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383930|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383931|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383932|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383933|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383934|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383935|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383936|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383937|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383938|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383939|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383940|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383941|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383942|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383943|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383944|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383945|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383946|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383947|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383948|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383949|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383950|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383951|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383952|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383953|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383954|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383955|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383956|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383957|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383958|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383959|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383960|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383961|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383962|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383963|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383964|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383965|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383966|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
383967|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
383968|NCT00666757|E5|Reported Event|Sertraline|50-200 mg orally daily for 12 weeks
383969|NCT00666757|E4|Reported Event|Paroxetine|20-50 mg orally daily for 12 weeks
383970|NCT00666757|E3|Reported Event|Fluoxetine|20-80 mg orally daily for 12 weeks
383971|NCT00666757|E2|Reported Event|Citalopram|20-40 mg orally daily for 12 weeks
383972|NCT00666757|E1|Reported Event|Duloxetine|30-120 mg orally daily for 12 weeks
383973|NCT00666718|B3|Baseline|Total|Total of all reporting groups
383974|NCT00666718|B2|Baseline|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
383975|NCT00666718|B1|Baseline|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
383976|NCT00666718|P2|Participant Flow|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
383977|NCT00666718|P1|Participant Flow|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
383978|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383979|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383980|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383981|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383982|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383983|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383984|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383985|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383986|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383987|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383988|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383989|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383990|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383991|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383992|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383993|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383994|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383995|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383996|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383997|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
383998|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
383999|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
384000|NCT00666718|E2|Reported Event|Lispro/Metformin|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
384001|NCT00666718|E1|Reported Event|Glargine/Lispro|Glargine plus Insulin Lispro (2-3 injections) plus metformin
384002|NCT00666705|B1|Baseline|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
384003|NCT00666705|P1|Participant Flow|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
384004|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
384005|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
384006|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
384007|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
384008|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
384009|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
384010|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
384011|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
384012|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
384013|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
384014|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
384015|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
384016|NCT00666705|E3|Reported Event|Raltegravir|400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
384152|NCT00666458|E1|Reported Event|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
384017|NCT00666705|E2|Reported Event|Maraviroc + Raltegravir|On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
384018|NCT00666705|E1|Reported Event|Maraviroc|300 milligrams (mg) every 12 hours on Study Days 6-11
384019|NCT00666679|B3|Baseline|Total|Total of all reporting groups
384020|NCT00666679|B2|Baseline|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
384021|NCT00666679|B1|Baseline|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
384022|NCT00666679|P2|Participant Flow|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
384023|NCT00666679|P1|Participant Flow|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
384024|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384025|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384026|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384027|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384028|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384029|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384030|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384031|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384032|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384033|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384034|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384035|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384036|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384037|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384038|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384039|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384040|NCT00666679|E2|Reported Event|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
384041|NCT00666679|E1|Reported Event|Montelukast + Mometasone|Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
384042|NCT00666666|B1|Baseline|AT101 (R-(-)-Gossypol Acetic Acid)|
384043|NCT00666666|P1|Participant Flow|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
384044|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
384082|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384153|NCT00666406|B1|Baseline|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
384045|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
384046|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
384047|NCT00666666|E1|Reported Event|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
384048|NCT00666588|B5|Baseline|Total|Total of all reporting groups
384049|NCT00666588|B4|Baseline|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384050|NCT00666588|B3|Baseline|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384051|NCT00666588|B2|Baseline|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384052|NCT00666588|B1|Baseline|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
384053|NCT00666588|P4|Participant Flow|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384054|NCT00666588|P3|Participant Flow|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384143|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
384144|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
384055|NCT00666588|P2|Participant Flow|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384056|NCT00666588|P1|Participant Flow|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
384057|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384058|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384059|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384060|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
384061|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384062|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384063|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384081|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384145|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
384146|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
384064|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
384065|NCT00666588|E4|Reported Event|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384066|NCT00666588|E3|Reported Event|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384067|NCT00666588|E2|Reported Event|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
384068|NCT00666588|E1|Reported Event|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
384069|NCT00666562|B4|Baseline|Total|Total of all reporting groups
384070|NCT00666562|B3|Baseline|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384071|NCT00666562|B2|Baseline|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384072|NCT00666562|B1|Baseline|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384073|NCT00666562|P3|Participant Flow|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384074|NCT00666562|P2|Participant Flow|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384075|NCT00666562|P1|Participant Flow|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384076|NCT00666562|O4|Outcome|7/7 Genotype|Genotype of the UGT in EGCG
384077|NCT00666562|O3|Outcome|6/7 Genotype|Genotype of the UGT in EGCG
384078|NCT00666562|O2|Outcome|6/6 Genotype|Genotype of the UGT in EGCG
384079|NCT00666562|O1|Outcome|5/6 Genotype|Genotype of the UGT in EGCG
384080|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384330|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384083|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384084|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384085|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384086|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384087|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384088|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384089|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384090|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384091|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384092|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384093|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384094|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384095|NCT00666562|O3|Outcome|Alanine/Alanine|A to A transition in the COMT gene
384096|NCT00666562|O2|Outcome|Alanine/Glycine|A to G transition in the COMT gene
384097|NCT00666562|O1|Outcome|Glycine/Glycine|G to G transition in the COMT gene
384098|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384099|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384100|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384101|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384147|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
384102|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384103|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384104|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384105|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384106|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384107|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384108|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384109|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384110|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384111|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384112|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384113|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384114|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384115|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384116|NCT00666562|E3|Reported Event|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384117|NCT00666562|E2|Reported Event|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384118|NCT00666562|E1|Reported Event|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
384119|NCT00666536|B3|Baseline|Total|Total of all reporting groups
384120|NCT00666536|B2|Baseline|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384121|NCT00666536|B1|Baseline|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384122|NCT00666536|P2|Participant Flow|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384123|NCT00666536|P1|Participant Flow|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384124|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384125|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384126|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384127|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384128|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384129|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384130|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384131|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384132|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384133|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384134|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384135|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384136|NCT00666536|E2|Reported Event|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384137|NCT00666536|E1|Reported Event|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
384138|NCT00666458|B3|Baseline|Total|Total of all reporting groups
384139|NCT00666458|B2|Baseline|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
384140|NCT00666458|B1|Baseline|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
384141|NCT00666458|P2|Participant Flow|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
384142|NCT00666458|P1|Participant Flow|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
384154|NCT00666406|P2|Participant Flow|Recombinate rAHF Then Advate rAHF-PFM|"First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight"
384155|NCT00666406|P1|Participant Flow|Advate rAHF-PFM Then Recombinate rAHF|"First infusion - Advate Antihemophilic Factor (Recombinant)–Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight"
384156|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384157|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384158|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384159|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384160|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384161|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384162|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384163|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384164|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384165|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384166|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384167|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384168|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384169|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384170|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384171|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384172|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384173|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384174|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384175|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384176|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384177|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384178|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384179|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384180|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384181|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384182|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384183|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384184|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384185|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384186|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384187|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384188|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384189|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384190|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384191|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384192|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384193|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384194|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384195|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384196|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384197|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384198|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384199|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384200|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384201|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384202|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384203|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384204|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384205|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384206|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384207|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384208|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384209|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384210|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384211|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384212|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384214|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384215|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384216|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384217|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384218|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384219|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384220|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384221|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384222|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384223|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384224|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384225|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384226|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
384227|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
384228|NCT00666406|E1|Reported Event|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
384229|NCT00666328|B1|Baseline|Clevidipine|"mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
384230|NCT00666328|P1|Participant Flow|Clevidipine|Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
384231|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384232|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384233|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384234|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours
384235|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384236|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384237|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for 30 minutes to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
384238|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384455|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
384456|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
384457|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
384239|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384240|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
384241|NCT00666328|E1|Reported Event|Clevidipine|"Safety Population (n=35): This population is the primary population for the safety analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
384242|NCT00666276|B1|Baseline|Linezolid|Participants who have been treated with Linezolid.
384243|NCT00666276|P1|Participant Flow|Linezolid|Participants who have been treated with Linezolid.
384244|NCT00666276|O2|Outcome|Linezolid-with Non-drug Therapies|Participants with Non-drug therapies who have been treated with Linezolid.
384245|NCT00666276|O1|Outcome|Linezolid-without Non-drug Therapies|Participants without Non-drug therapies who have been treated with Linezolid.
384246|NCT00666276|O2|Outcome|Linezolid-with Concomitant Drugs|Participants with Concomitant drugs who have been treated with Linezolid.
384247|NCT00666276|O1|Outcome|Linezolid-without Concomitant Drugs|Participants without Concomitant drugs who have been treated with Linezolid.
384248|NCT00666276|O2|Outcome|Linezolid -Less Than 40kg|Participants less than 40kg who have been treated with Linezolid.
384249|NCT00666276|O1|Outcome|Linezolid -Over 40kg|Participants over 40kg who have been treated with Linezolid.
384250|NCT00666276|O3|Outcome|Linezolid-oral From Injection|Participants with who have been treated with Linezolid by orally from injection .
384251|NCT00666276|O2|Outcome|Linezolid-injection|Participants with who have been treated with Linezolid by injection.
384252|NCT00666276|O1|Outcome|Linezolid-oral|Participants with who have been orally treated with Linezolid.
384253|NCT00666276|O2|Outcome|Linezolid-administrated Less Than 15 Days|Participants with who have been treated with Linezolid.with Duration of drug administration less than 15 days
384254|NCT00666276|O1|Outcome|Linezolid-administrated Over 15 Days|Participants who have been treated with Linezolid.with Duration of drug administration over 15 days
384255|NCT00666276|O2|Outcome|Linezolid- With Renal Dysfunctions|Participants with Renal dysfunctions who have been treated with Linezolid.
384256|NCT00666276|O1|Outcome|Linezolid Without Renal Dysfunctions|Participants without Renal dysfunctions who have been treated with Linezolid.
384257|NCT00666276|O2|Outcome|Linezolid- With Hepatic Dysfunctions|Participants with Hepatic dysfunctions who have been treated with Linezolid.
384258|NCT00666276|O1|Outcome|Linezolid-without Hepatic Dysfunctions|Participants with or without Hepatic dysfunctions who have been treated with Linezolid.
384259|NCT00666276|O2|Outcome|Linezolid-less Than 65|Participants with less than 65 years old who have been treated with Linezolid.
384260|NCT00666276|O1|Outcome|Linezolid-over 65|Participants with over 65 years old who have been treated with Linezolid.
384261|NCT00666276|O2|Outcome|Linezolid-female|Female participants who have been treated with Linezolid.
384262|NCT00666276|O1|Outcome|Linezolid-male|Male participants who have been treated with Linezolid.
384263|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
384264|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
384265|NCT00666276|E1|Reported Event|Linezolid|Participants who have been treated with Linezolid.
384266|NCT00666263|B1|Baseline|All Study Participants|"Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval.~Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)"
384267|NCT00666263|P2|Participant Flow|Placebo Then IGIV, 10% (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
384346|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384347|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384521|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384268|NCT00666263|P1|Participant Flow|IGIV, 10% Then Placebo (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
384269|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384270|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384271|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384272|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384273|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384274|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384275|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384276|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384348|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384349|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384350|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384351|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384352|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384277|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384278|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384279|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384280|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384281|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384282|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384283|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384284|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384285|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384439|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384440|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384441|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384442|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384443|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384286|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384287|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384288|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384289|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384290|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384291|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384292|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384293|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384294|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384444|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384445|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384446|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384447|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384448|NCT00666211|E2|Reported Event|Opioid Titration|Pain will be Monitored and Medication Titrated
384295|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384296|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384297|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384298|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384299|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384300|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384301|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384302|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384303|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384449|NCT00666211|E1|Reported Event|Standard of Care|Standard pain control drugs.
384450|NCT00666029|B3|Baseline|Total|Total of all reporting groups
384451|NCT00666029|B2|Baseline|Placebo|"Placebo arm dummy pill~placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
384304|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384305|NCT00666263|O4|Outcome|No Deterioration After IGIV, 10% or Placebo|Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
384306|NCT00666263|O3|Outcome|Deterioration After IGIV, 10%, But Not Placebo|Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
384307|NCT00666263|O2|Outcome|Deterioration After Placebo, But Not IGIV, 10%|Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
384308|NCT00666263|O1|Outcome|Deterioration After IGIV, 10% and Placebo|Participants with deterioration in GNDS scores after IGIV, 10% and placebo
384309|NCT00666263|O4|Outcome|No Decline During Placebo and IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
384310|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
384311|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
384312|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
384313|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384314|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384315|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384316|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384317|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384318|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384319|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384320|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384321|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384322|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384323|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384324|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384325|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384326|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384327|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384328|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384329|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384331|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384332|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384333|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384334|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384335|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384336|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384337|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384338|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384339|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384340|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384341|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384342|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384343|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384344|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384345|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384458|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
384459|NCT00666029|E2|Reported Event|Placebo|"Placebo arm dummy pill~placebo: Placebo"
384353|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384354|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384355|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384356|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384357|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384358|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384359|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384360|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384361|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384362|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384363|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384364|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384365|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384366|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384367|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384368|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384369|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384370|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384371|NCT00666263|O6|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384372|NCT00666263|O5|Outcome|End of Stabilization 3|(IGIV, 10%)
384373|NCT00666263|O4|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384374|NCT00666263|O3|Outcome|End of Stabilization 2|(IGIV, 10%)
384375|NCT00666263|O2|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384376|NCT00666263|O1|Outcome|End of Stabilization 1|(IGIV, 10%)
384377|NCT00666263|O4|Outcome|No Accelerated Switch During IGIV, 10% or Placebo|Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
384378|NCT00666263|O3|Outcome|Accelerated Switch During IGIV, 10%, But Not Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
384379|NCT00666263|O2|Outcome|Accelerated Switch During Placebo, But Not IGIV, 10%|Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
384380|NCT00666263|O1|Outcome|Accelerated Switch During IGIV, 10% and Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
384452|NCT00666029|B1|Baseline|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
384453|NCT00666029|P2|Participant Flow|Placebo|"Placebo arm dummy pill~placebo: Placebo"
384454|NCT00666029|P1|Participant Flow|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
384381|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384382|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384383|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384384|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384385|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384386|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384387|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384388|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384389|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384390|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384391|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384392|NCT00666263|O4|Outcome|No Decline During Placebo or IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
384393|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
384394|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
384395|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
384396|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384397|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384398|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384399|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
384400|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
384401|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
384402|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
384403|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
384404|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
384405|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
384406|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
384407|NCT00666263|E2|Reported Event|Placebo|0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
384408|NCT00666263|E1|Reported Event|IGIV, 10%|Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)
384409|NCT00666224|B3|Baseline|Total|Total of all reporting groups
384410|NCT00666224|B2|Baseline|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384411|NCT00666224|B1|Baseline|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384412|NCT00666224|P2|Participant Flow|Placebo (DB) to GA (OL)|Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
384413|NCT00666224|P1|Participant Flow|Glatiramer Acetate|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period.
384414|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384415|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384416|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384417|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384418|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384419|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384420|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384421|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384422|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384423|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384424|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384425|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
384426|NCT00666224|E3|Reported Event|Glatiramer Acetate (Entire Study)|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
384427|NCT00666224|E2|Reported Event|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data.
384428|NCT00666224|E1|Reported Event|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
384429|NCT00666211|B3|Baseline|Total|Total of all reporting groups
384430|NCT00666211|B2|Baseline|Opioid Titration|Pain will be Monitored and Medication Titrated
384431|NCT00666211|B1|Baseline|Standard of Care|Standard pain control drugs.
384432|NCT00666211|P2|Participant Flow|Opioid Titration|Pain will be Monitored and Medication Titrated
384433|NCT00666211|P1|Participant Flow|Standard of Care|Standard pain control drugs.
384434|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384435|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384436|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384437|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
384438|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
384460|NCT00666029|E1|Reported Event|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
384461|NCT00665925|B5|Baseline|Total|Total of all reporting groups
384462|NCT00665925|B4|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384463|NCT00665925|B3|Baseline|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384464|NCT00665925|B2|Baseline|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384465|NCT00665925|B1|Baseline|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384466|NCT00665925|P4|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384467|NCT00665925|P3|Participant Flow|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384468|NCT00665925|P2|Participant Flow|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384469|NCT00665925|P1|Participant Flow|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384470|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384471|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384472|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384473|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384474|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384475|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384476|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384477|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384478|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384479|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384480|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384481|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384482|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384483|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384484|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384485|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384486|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384487|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384488|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384489|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384490|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384491|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384492|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384493|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384494|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384495|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384496|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384497|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384498|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384499|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384500|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384501|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384502|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384503|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384504|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384505|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384506|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384507|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384508|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384509|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384510|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384511|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384512|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384513|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384514|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384515|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384516|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384517|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384518|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384519|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384520|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384522|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384523|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384524|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384525|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384526|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384527|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384528|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384529|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384530|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384531|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384532|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384533|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384534|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384535|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384536|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384537|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384538|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384539|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384540|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384541|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384542|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384543|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384544|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384545|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384546|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384547|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384548|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384549|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384550|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384551|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384552|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384553|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384554|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384555|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384556|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384557|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384558|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384559|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384560|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384561|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384562|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384563|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384564|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384565|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384566|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384567|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384568|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384569|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384570|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384571|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384572|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384573|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384574|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384575|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384576|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384577|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384578|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384579|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384580|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384581|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384582|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384583|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384584|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384585|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384586|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384587|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384588|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384589|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384590|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384591|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384592|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384593|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384594|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384595|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384596|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384597|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384598|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384599|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384600|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384601|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384602|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384603|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384604|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384605|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384606|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384607|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384608|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384609|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384610|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384611|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384612|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384613|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384614|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384615|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384616|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384617|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384618|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384619|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384620|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384621|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384622|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384623|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384624|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384625|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384626|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384627|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384628|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384629|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384630|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384631|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384632|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384633|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384634|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384635|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384636|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384637|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384638|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384639|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384640|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384641|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384642|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384643|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384644|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384645|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384646|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384647|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384648|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384649|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384650|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384651|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384652|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384653|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384654|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384655|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384656|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384657|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384658|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384659|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384660|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384661|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384662|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384663|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384664|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384665|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384666|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384667|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384668|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384669|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384670|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384671|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384672|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384673|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384674|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384675|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384676|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384677|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384678|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384679|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384680|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384681|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384682|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384683|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384684|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384685|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384686|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384687|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384688|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384689|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384690|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384691|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384692|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384693|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384694|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384695|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384696|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384697|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384698|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384699|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384700|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384701|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384702|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384703|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384704|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384705|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384706|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384707|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384708|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384709|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384710|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384711|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384712|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384713|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384714|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384715|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384716|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384717|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384718|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384719|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384720|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384721|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384722|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384723|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384724|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384725|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384726|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384727|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384728|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384729|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384730|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384731|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384732|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384733|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384734|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384735|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384736|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384737|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384738|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384739|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384740|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384741|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384742|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384743|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384744|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384745|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384746|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384747|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384748|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384749|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384750|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384751|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384752|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384753|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384754|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384755|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384756|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384757|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384758|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384759|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384760|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384761|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384762|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384763|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384764|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384765|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384766|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384767|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384768|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384769|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384770|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384771|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384772|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384773|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384774|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384775|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384776|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384777|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384778|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384779|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384780|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384781|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384782|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384783|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384784|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384785|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384786|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384787|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384788|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384789|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384790|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384791|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384792|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384793|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384794|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384795|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384796|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384797|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384798|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384799|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384800|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384801|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384802|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384803|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384804|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384805|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384806|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384807|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384808|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384809|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384810|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384811|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384812|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384813|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384814|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384815|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384816|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384817|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384818|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384819|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384820|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384821|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384822|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384823|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384824|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384825|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384826|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384827|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384828|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384829|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384830|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384831|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384832|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384833|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384834|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384835|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384836|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384837|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384838|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384839|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384840|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384841|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384842|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384843|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384844|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384845|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384846|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384847|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384848|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384849|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384850|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384851|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384852|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384853|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384854|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384855|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384856|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384857|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384858|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384859|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384860|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384861|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384862|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384863|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384864|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384865|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384866|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384867|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384868|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384869|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384870|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384871|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384872|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
384873|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384874|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384875|NCT00665925|E4|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384876|NCT00665925|E3|Reported Event|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
384877|NCT00665925|E2|Reported Event|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
384878|NCT00665925|E1|Reported Event|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
384879|NCT00665847|B1|Baseline|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
384880|NCT00665847|P1|Participant Flow|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
384881|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384882|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384883|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384884|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384885|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384886|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384887|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384888|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384889|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
384890|NCT00665847|E1|Reported Event|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
384891|NCT00665704|B1|Baseline|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
384892|NCT00665704|P1|Participant Flow|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
384893|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
384894|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
384895|NCT00665704|E1|Reported Event|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
384896|NCT00665626|B3|Baseline|Total|Total of all reporting groups
384897|NCT00665626|B2|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384898|NCT00665626|B1|Baseline|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384899|NCT00665626|P2|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384900|NCT00665626|P1|Participant Flow|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384901|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384902|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384903|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384904|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384905|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384906|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384907|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384908|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384909|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384910|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384911|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384912|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384913|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384914|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384915|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384916|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384917|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384918|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384919|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384920|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384921|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384922|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384923|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384924|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384925|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384926|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384927|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384928|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384929|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384930|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384931|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384932|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384933|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384934|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384935|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384936|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384937|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384938|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384939|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384940|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384941|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384942|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
386760|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
384943|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384944|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384945|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384946|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384947|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384948|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384949|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384950|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384951|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384952|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384953|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384954|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384955|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384956|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384957|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384958|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384959|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384960|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384961|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384962|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384963|NCT00665626|E2|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
384964|NCT00665626|E1|Reported Event|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
384965|NCT00665470|B3|Baseline|Total|Total of all reporting groups
384966|NCT00665470|B2|Baseline|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
384967|NCT00665470|B1|Baseline|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
384968|NCT00665470|P2|Participant Flow|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
384969|NCT00665470|P1|Participant Flow|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
384970|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
384971|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
384972|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
384973|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
384974|NCT00665470|E2|Reported Event|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
384975|NCT00665470|E1|Reported Event|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
384976|NCT00665444|B1|Baseline|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
384977|NCT00665444|P1|Participant Flow|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
384978|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
384979|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
384980|NCT00665444|E1|Reported Event|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
384981|NCT00665431|B4|Baseline|Total|Total of all reporting groups
384982|NCT00665431|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384983|NCT00665431|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384984|NCT00665431|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
384985|NCT00665431|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384986|NCT00665431|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384987|NCT00665431|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
384988|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384989|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384990|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
384991|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384992|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384993|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
384994|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384995|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384996|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
384997|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
384998|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
384999|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385000|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385001|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385002|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385003|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385004|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385005|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385006|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385007|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385008|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385009|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385010|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385011|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385012|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385013|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385014|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385015|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385016|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385017|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385018|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385019|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385020|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385021|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385022|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385023|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385024|NCT00665431|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385025|NCT00665431|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385026|NCT00665431|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
385027|NCT00665366|B3|Baseline|Total|Total of all reporting groups
385028|NCT00665366|B2|Baseline|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385029|NCT00665366|B1|Baseline|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385067|NCT00665353|E1|Reported Event|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385116|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385117|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385030|NCT00665366|P2|Participant Flow|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385031|NCT00665366|P1|Participant Flow|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385032|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385033|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385034|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385035|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385036|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385037|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385038|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385039|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385040|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385041|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385042|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385043|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385044|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385045|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385068|NCT00665132|B1|Baseline|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385557|NCT00663117|O1|Outcome|Placebo|Quality of life in subjects on placebo treatment for 12 weeks
385046|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385047|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385048|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385049|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385050|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385051|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385052|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385053|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385054|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
385055|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
385056|NCT00665366|E2|Reported Event|Placebo|
385057|NCT00665366|E1|Reported Event|Aripiprazole|
385058|NCT00665353|B1|Baseline|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385059|NCT00665353|P1|Participant Flow|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385060|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385061|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385062|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385063|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385064|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385065|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385066|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
385114|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385115|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385069|NCT00665132|P1|Participant Flow|StimRouter Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385070|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385071|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385072|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385073|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385074|NCT00665132|E1|Reported Event|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
385075|NCT00665002|B1|Baseline|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
385076|NCT00665002|P1|Participant Flow|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
385077|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
385078|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
385079|NCT00665002|E1|Reported Event|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks.
385080|NCT00664742|B1|Baseline|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
385081|NCT00664742|P1|Participant Flow|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
385082|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
385083|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
385084|NCT00664742|E1|Reported Event|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
385085|NCT00664560|B4|Baseline|Total|Total of all reporting groups
385086|NCT00664560|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385087|NCT00664560|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385088|NCT00664560|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385089|NCT00664560|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385090|NCT00664560|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385091|NCT00664560|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385092|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385093|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385094|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385095|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385096|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385097|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385098|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385099|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385100|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385101|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385102|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385103|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385104|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385105|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385106|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385107|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385108|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385109|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385110|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385111|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385112|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385113|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385118|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385119|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385120|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385121|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385122|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385123|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385124|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385125|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385126|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385127|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385128|NCT00664560|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
385129|NCT00664560|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
385130|NCT00664560|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
385131|NCT00664534|B3|Baseline|Total|Total of all reporting groups
385132|NCT00664534|B2|Baseline|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385133|NCT00664534|B1|Baseline|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385134|NCT00664534|P2|Participant Flow|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385135|NCT00664534|P1|Participant Flow|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385136|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385137|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385138|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385139|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385140|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385141|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385142|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385143|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385144|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385145|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385146|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385147|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385148|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385149|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385150|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385151|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385152|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385153|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385154|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385155|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385156|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
385157|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
385158|NCT00664534|E2|Reported Event|Glargine|Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
385159|NCT00664534|E1|Reported Event|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
385160|NCT00664521|B3|Baseline|Total|Total of all reporting groups
385161|NCT00664521|B2|Baseline|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385162|NCT00664521|B1|Baseline|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385163|NCT00664521|P2|Participant Flow|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385164|NCT00664521|P1|Participant Flow|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385165|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385193|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385166|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385167|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385168|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385169|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385170|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385171|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385172|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385173|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385174|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385175|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385176|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385177|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385178|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385179|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385180|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385181|NCT00664521|E2|Reported Event|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
385182|NCT00664521|E1|Reported Event|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
385183|NCT00664430|B1|Baseline|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385184|NCT00664430|P1|Participant Flow|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385185|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385186|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385187|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385188|NCT00664430|E1|Reported Event|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
385189|NCT00664326|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385190|NCT00664326|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385191|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385192|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385194|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385195|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385196|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385197|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385198|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385199|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385200|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385201|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385202|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385203|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385204|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385205|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385206|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385207|NCT00664326|E1|Reported Event|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
385208|NCT00664105|B1|Baseline|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385209|NCT00664105|P1|Participant Flow|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385210|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385211|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385212|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385213|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385214|NCT00664105|E1|Reported Event|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
385215|NCT00664066|B1|Baseline|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
385216|NCT00664066|P1|Participant Flow|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
385217|NCT00664066|O1|Outcome|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
385218|NCT00664066|E1|Reported Event|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
385219|NCT00663962|B3|Baseline|Total|Total of all reporting groups
385220|NCT00663962|B2|Baseline|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
385221|NCT00663962|B1|Baseline|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
385222|NCT00663962|P2|Participant Flow|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
385223|NCT00663962|P1|Participant Flow|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
385224|NCT00663962|O2|Outcome|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
385225|NCT00663962|O1|Outcome|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
385226|NCT00663962|E2|Reported Event|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
385865|NCT00662675|E1|Reported Event|Placebo|Matching placebo capsules taken by mouth per meal or snack
385227|NCT00663962|E1|Reported Event|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
385228|NCT00663923|B1|Baseline|Photorefractive Keratectomy( PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .In single method the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385229|NCT00663923|P1|Participant Flow|Photorefractivekeratectomy(PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .in single method,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385230|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385231|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385232|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385233|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385234|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385235|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385236|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385237|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385238|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385239|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385240|NCT00663923|E2|Reported Event|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
385241|NCT00663923|E1|Reported Event|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
385242|NCT00663858|B4|Baseline|Total|Total of all reporting groups
385243|NCT00663858|B3|Baseline|Placebo|Placebo on Week 0, 2, 26 and 28.
385244|NCT00663858|B2|Baseline|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
385245|NCT00663858|B1|Baseline|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
385246|NCT00663858|P3|Participant Flow|Placebo|Placebo on Week 0, 2, 26 and 28.
385247|NCT00663858|P2|Participant Flow|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
385248|NCT00663858|P1|Participant Flow|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
385249|NCT00663858|O3|Outcome|Placebo|Placebo on Week 0, 2, 26 and 28.
385250|NCT00663858|O2|Outcome|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
385251|NCT00663858|O1|Outcome|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
385252|NCT00663858|E3|Reported Event|Placebo|Placebo on Week 0, 2, 26 and 28.
385253|NCT00663858|E2|Reported Event|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
385254|NCT00663858|E1|Reported Event|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
385255|NCT00663819|B3|Baseline|Total|Total of all reporting groups
385866|NCT00662649|B5|Baseline|Total|Total of all reporting groups
385256|NCT00663819|B2|Baseline|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
385257|NCT00663819|B1|Baseline|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
385258|NCT00663819|P2|Participant Flow|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
385259|NCT00663819|P1|Participant Flow|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
385260|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
385261|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
385262|NCT00663819|E2|Reported Event|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
385263|NCT00663819|E1|Reported Event|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
385264|NCT00663793|B3|Baseline|Total|Total of all reporting groups
385265|NCT00663793|B2|Baseline|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385266|NCT00663793|B1|Baseline|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385267|NCT00663793|P2|Participant Flow|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385268|NCT00663793|P1|Participant Flow|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385269|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385270|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385271|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385272|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
386542|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
385273|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385274|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385275|NCT00663793|E2|Reported Event|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385276|NCT00663793|E1|Reported Event|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
385277|NCT00663702|B3|Baseline|Total|Total of all reporting groups
385278|NCT00663702|B2|Baseline|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385279|NCT00663702|B1|Baseline|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385280|NCT00663702|P2|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385281|NCT00663702|P1|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385282|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385283|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385284|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385285|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385286|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385323|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385664|NCT00663026|O3|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
386761|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
385287|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385288|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385289|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385290|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385291|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385292|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385293|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385294|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385295|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385296|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385297|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385298|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385299|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385300|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385301|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385302|NCT00663702|E1|Reported Event|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
385303|NCT00663403|B1|Baseline|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385304|NCT00663403|P1|Participant Flow|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385305|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385306|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385307|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385308|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385309|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385310|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385311|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385312|NCT00663403|E1|Reported Event|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
385313|NCT00663260|B4|Baseline|Total|Total of all reporting groups
385314|NCT00663260|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385315|NCT00663260|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385316|NCT00663260|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385317|NCT00663260|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385318|NCT00663260|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385319|NCT00663260|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385320|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385321|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385322|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385324|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385325|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385326|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385327|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385328|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385329|NCT00663260|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385330|NCT00663260|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
385331|NCT00663260|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
385332|NCT00663234|B1|Baseline|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385333|NCT00663234|P1|Participant Flow|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
385334|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385335|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385336|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385337|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385338|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385339|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385340|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385341|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385342|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385343|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385344|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385345|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385346|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385347|NCT00663234|O2|Outcome|NNRTI-unexposed|Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
385348|NCT00663234|O1|Outcome|NNRTI-exposed|Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
385349|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385350|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
385351|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385352|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385353|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385354|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385355|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385356|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385357|NCT00663234|E1|Reported Event|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
385358|NCT00663208|B8|Baseline|Total|Total of all reporting groups
385359|NCT00663208|B7|Baseline|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
386543|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
385360|NCT00663208|B6|Baseline|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385361|NCT00663208|B5|Baseline|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385362|NCT00663208|B4|Baseline|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385363|NCT00663208|B3|Baseline|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385364|NCT00663208|B2|Baseline|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385365|NCT00663208|B1|Baseline|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385366|NCT00663208|P7|Participant Flow|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385367|NCT00663208|P6|Participant Flow|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385368|NCT00663208|P5|Participant Flow|Daclatasvir (30 mg) BID|Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385369|NCT00663208|P4|Participant Flow|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385370|NCT00663208|P3|Participant Flow|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385371|NCT00663208|P2|Participant Flow|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385372|NCT00663208|P1|Participant Flow|Daclatasvir (1 mg) QD|Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385373|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385374|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385375|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385376|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385377|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385378|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385379|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385380|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385381|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385382|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385383|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385384|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385385|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385386|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385387|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385388|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385389|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
386544|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
385390|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385391|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385392|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385393|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385394|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385395|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385396|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385397|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385398|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385399|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385400|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385401|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385402|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385403|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385404|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385405|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385406|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385407|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385408|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385409|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385410|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385411|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385412|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385413|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385414|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385415|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385416|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385417|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385418|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385419|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385554|NCT00663117|O2|Outcome|Naltrexone 4.5 mg|naltrexone 4.5 mg for 12 weeks blinded followed by naltrexone 4.5 mg open labeled
385420|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385421|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385422|NCT00663208|O1|Outcome|All Daclatasvir Treated Participants|All participants who received daclatasvir during 14 day treatment period.
385423|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385424|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385425|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385426|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385427|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385428|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385429|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385430|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385431|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385432|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385433|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385434|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385435|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385436|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385437|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385438|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385439|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385440|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385441|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385442|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385443|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385444|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385445|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385446|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385447|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385448|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385449|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385450|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
386762|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
385451|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385452|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385453|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385454|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385455|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385456|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385457|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385458|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385459|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385460|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385461|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385462|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385463|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385464|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385465|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385466|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385467|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385468|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385469|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385470|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385471|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385472|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385473|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385474|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385475|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385476|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385477|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385478|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385479|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385480|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385555|NCT00663117|O1|Outcome|Placebo|Placebo for 12 weeks blinded followed by naltrexone 4.5mg open labeled
386763|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
385481|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385482|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385483|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385484|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385485|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385486|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385487|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385488|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385489|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385490|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385491|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385492|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385493|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385494|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385495|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385496|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
385497|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385498|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385499|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385500|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385501|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385502|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385503|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385504|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385505|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385506|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385507|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385508|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385509|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385510|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385556|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Quality of life on naltrexone treatment 12 weeks
385511|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385512|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385513|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385514|NCT00663208|E7|Reported Event|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
385515|NCT00663208|E6|Reported Event|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385516|NCT00663208|E5|Reported Event|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385517|NCT00663208|E4|Reported Event|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385518|NCT00663208|E3|Reported Event|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385519|NCT00663208|E2|Reported Event|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385520|NCT00663208|E1|Reported Event|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
385521|NCT00663169|B3|Baseline|Total|Total of all reporting groups
385522|NCT00663169|B2|Baseline|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385523|NCT00663169|B1|Baseline|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385524|NCT00663169|P2|Participant Flow|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385525|NCT00663169|P1|Participant Flow|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385526|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385527|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385528|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385529|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385530|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385531|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385532|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385533|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385534|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385535|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385536|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385537|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385538|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385539|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385540|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385541|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385542|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385543|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385544|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385545|NCT00663169|E2|Reported Event|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
385546|NCT00663169|E1|Reported Event|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
385547|NCT00663117|B3|Baseline|Total|Total of all reporting groups
385548|NCT00663117|B2|Baseline|Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
385549|NCT00663117|B1|Baseline|Placebo Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
385550|NCT00663117|P2|Participant Flow|Naltrexone Then Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
385551|NCT00663117|P1|Participant Flow|Placebo Then Naltrexone 4.5 mg Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
385552|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Subjects who received naltrexone 4.5 mg by mouth once a day for 3 months
385553|NCT00663117|O1|Outcome|Placebo|Subjects who received placebo for 3 months
385558|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
385559|NCT00663117|O1|Outcome|Placebo|Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
385560|NCT00663117|E2|Reported Event|Naltrexone 4.5 mg|All participants who received naltrexone either for 12 or 24 weeks.
385561|NCT00663117|E1|Reported Event|Placebo|Participants who received placebo for the first 12 weeks.
385562|NCT00663052|B3|Baseline|Total|Total of all reporting groups
385563|NCT00663052|B2|Baseline|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385564|NCT00663052|B1|Baseline|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385565|NCT00663052|P2|Participant Flow|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385566|NCT00663052|P1|Participant Flow|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385567|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385568|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385569|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385570|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385571|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385572|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385573|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385574|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385575|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385576|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385577|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385578|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385579|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385580|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385581|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385582|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385583|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385584|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385585|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385586|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385587|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385588|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385589|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385590|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385591|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
386764|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
385592|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385593|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385594|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385595|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385596|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385597|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385598|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385599|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385600|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385601|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385602|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385603|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385604|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385605|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385606|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385607|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385608|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385609|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385610|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385611|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385612|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385613|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385614|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385615|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385616|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385617|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385618|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385619|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385620|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385621|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385622|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385623|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385665|NCT00663026|O2|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385624|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385625|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385626|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385627|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385628|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385629|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385630|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385631|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385632|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385633|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385634|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385635|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385636|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385637|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385638|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385639|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385640|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385641|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385642|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385643|NCT00663052|E2|Reported Event|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
385644|NCT00663052|E1|Reported Event|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
385645|NCT00663026|B4|Baseline|Total|Total of all reporting groups
385646|NCT00663026|B3|Baseline|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385647|NCT00663026|B2|Baseline|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385648|NCT00663026|B1|Baseline|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
385649|NCT00663026|P3|Participant Flow|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385650|NCT00663026|P2|Participant Flow|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385651|NCT00663026|P1|Participant Flow|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
385652|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385653|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385654|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385655|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385656|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385657|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385658|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385659|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385660|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385661|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385662|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385663|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385666|NCT00663026|O1|Outcome|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
385667|NCT00663026|E3|Reported Event|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
385668|NCT00663026|E2|Reported Event|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
385669|NCT00663026|E1|Reported Event|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
385670|NCT00662909|B4|Baseline|Total|Total of all reporting groups
385671|NCT00662909|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385672|NCT00662909|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385673|NCT00662909|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385674|NCT00662909|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385675|NCT00662909|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385676|NCT00662909|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385677|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385678|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385679|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385680|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385681|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385682|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385683|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385684|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385685|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385686|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385687|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385688|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385689|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385690|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385691|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385692|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385693|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385694|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385695|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385696|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385697|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385698|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385699|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385700|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385701|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385702|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385703|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385704|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385705|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385706|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385707|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385708|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385709|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385710|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385711|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385712|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385713|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385714|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385715|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385716|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385717|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385718|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385719|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385720|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385721|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385722|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385723|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385724|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385725|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385726|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385727|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385728|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385729|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385730|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385731|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385732|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385733|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385734|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385735|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385736|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385737|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385738|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385739|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385740|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385741|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385742|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385743|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385744|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385745|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385746|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385747|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385748|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385749|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385750|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385751|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385752|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385753|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385754|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385755|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385756|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385757|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385758|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385759|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385760|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385761|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385762|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385763|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385764|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385765|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385766|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385767|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385768|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385769|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385770|NCT00662909|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
385771|NCT00662909|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
385772|NCT00662909|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
385773|NCT00662857|B1|Baseline|Safety Population|Any subject that received at least one treatment with TI inhalation powder
385774|NCT00662857|P2|Participant Flow|TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
385775|NCT00662857|P1|Participant Flow|TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
385776|NCT00662857|O2|Outcome|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
385777|NCT00662857|O1|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
385778|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
385779|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
385780|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
385781|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
385782|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
385783|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
385784|NCT00662857|E3|Reported Event|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
385785|NCT00662857|E2|Reported Event|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
385786|NCT00662857|E1|Reported Event|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
385787|NCT00662831|B3|Baseline|Total|Total of all reporting groups
385788|NCT00662831|B2|Baseline|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385789|NCT00662831|B1|Baseline|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385790|NCT00662831|P2|Participant Flow|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385791|NCT00662831|P1|Participant Flow|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385792|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385793|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385794|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385795|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385796|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385797|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385798|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385799|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385800|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385801|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385802|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385803|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385804|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385805|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385806|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385807|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385808|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385809|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385810|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385811|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385812|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385813|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
386765|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
385814|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385815|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385816|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385817|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385818|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385819|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385820|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385821|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385822|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385823|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385824|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385825|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385826|NCT00662831|E2|Reported Event|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
385827|NCT00662831|E1|Reported Event|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
385828|NCT00662818|B3|Baseline|Total|Total of all reporting groups
385829|NCT00662818|B2|Baseline|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
385830|NCT00662818|B1|Baseline|Telcagepant 300 mg→APAP 1000 mg|Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
385831|NCT00662818|P2|Participant Flow|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
385832|NCT00662818|P1|Participant Flow|Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg|Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
385833|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385834|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385835|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385836|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385837|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385838|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385839|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385840|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385841|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
385842|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385843|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
385844|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385845|NCT00662818|O2|Outcome|Acetaminophen/Paracetamol (APAP)|Participants receiving APAP
385846|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385847|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385848|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385849|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
385850|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
385851|NCT00662818|E2|Reported Event|Acetaminophen/Paracetamol|Participants receiving acetaminophen/paracetamol
385852|NCT00662818|E1|Reported Event|Telcagepant|Participants receiving telcagepant
385853|NCT00662675|B3|Baseline|Total|Total of all reporting groups
385854|NCT00662675|B2|Baseline|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385855|NCT00662675|B1|Baseline|Placebo|Matching placebo capsules taken by mouth per meal or snack
385856|NCT00662675|P2|Participant Flow|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385857|NCT00662675|P1|Participant Flow|Placebo|Matching placebo capsules taken by mouth per meal or snack
385858|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385859|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
385860|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385861|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
385862|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385863|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
385864|NCT00662675|E2|Reported Event|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
385867|NCT00662649|B4|Baseline|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
385868|NCT00662649|B3|Baseline|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
385869|NCT00662649|B2|Baseline|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385870|NCT00662649|B1|Baseline|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385871|NCT00662649|P5|Participant Flow|Placebo-fingolimod 0.5|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
385872|NCT00662649|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
385873|NCT00662649|P3|Participant Flow|Placebo|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
385874|NCT00662649|P2|Participant Flow|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385875|NCT00662649|P1|Participant Flow|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385876|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
385877|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385878|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385879|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod (either 1.25 or 0.5 mg/day) in the Extension study.
385880|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385881|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385882|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
385883|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the Core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
385884|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385885|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385886|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
385887|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
385888|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385889|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385890|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
385891|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
385892|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385893|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385894|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
385895|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
385896|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385897|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385898|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
385899|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385900|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385901|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
385902|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
385903|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
386164|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
385904|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385905|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
385906|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
385907|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
385908|NCT00662649|E4|Reported Event|Placebo-Fingolimod 0.5mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
385909|NCT00662649|E3|Reported Event|Placebo-Fingolimod 1.25mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
385910|NCT00662649|E2|Reported Event|Fingolimod 0.5mg|Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
385911|NCT00662649|E1|Reported Event|Fingolimod 1.25mg|Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
385912|NCT00662558|B3|Baseline|Total|Total of all reporting groups
385913|NCT00662558|B2|Baseline|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385914|NCT00662558|B1|Baseline|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385915|NCT00662558|P2|Participant Flow|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385916|NCT00662558|P1|Participant Flow|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385917|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385918|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385919|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385920|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385921|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385922|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385923|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385924|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385925|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385926|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385927|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385928|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385929|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385930|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385931|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385932|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385933|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385934|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385935|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385936|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385937|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385938|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385939|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385940|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385941|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385942|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385943|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385944|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385945|NCT00662558|E2|Reported Event|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
385946|NCT00662558|E1|Reported Event|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
385947|NCT00662545|B3|Baseline|Total|Total of all reporting groups
385948|NCT00662545|B2|Baseline|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385949|NCT00662545|B1|Baseline|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385950|NCT00662545|P2|Participant Flow|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385951|NCT00662545|P1|Participant Flow|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385952|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385953|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385954|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385955|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385956|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
386545|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
385957|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385958|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385959|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385960|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385961|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385962|NCT00662545|E2|Reported Event|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
385963|NCT00662545|E1|Reported Event|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
385964|NCT00662532|B3|Baseline|Total|Total of all reporting groups
385965|NCT00662532|B2|Baseline|No Intervention|Control group receiving no drug intervention
385966|NCT00662532|B1|Baseline|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385967|NCT00662532|P2|Participant Flow|No Intervention|Control group receiving no drug intervention
385968|NCT00662532|P1|Participant Flow|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385969|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
385970|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385971|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
385972|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385973|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
385974|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385975|NCT00662532|E2|Reported Event|No Intervention|Control group receiving no drug intervention
385976|NCT00662532|E1|Reported Event|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
385977|NCT00662389|B1|Baseline|A--Thermal Wand Application|
385978|NCT00662389|P1|Participant Flow|A--Thermal Wand Application|
385979|NCT00662389|O1|Outcome|A--Thermal Wand Application|
385980|NCT00662363|B3|Baseline|Total|Total of all reporting groups
385981|NCT00662363|B2|Baseline|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
385982|NCT00662363|B1|Baseline|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
385983|NCT00662363|P2|Participant Flow|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
385984|NCT00662363|P1|Participant Flow|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
385985|NCT00662363|O2|Outcome|Senna|Change in PAC-QOL
385986|NCT00662363|O1|Outcome|Lubiprostone|change in PAC-QOL
385987|NCT00662363|O2|Outcome|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
385988|NCT00662363|O1|Outcome|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
385989|NCT00662363|E2|Reported Event|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
385990|NCT00662363|E1|Reported Event|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
385991|NCT00662207|B1|Baseline|All Participants|
385992|NCT00662207|P1|Participant Flow|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
385993|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
385994|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
385995|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
386028|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
385996|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
385997|NCT00662207|E1|Reported Event|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
385998|NCT00662025|B1|Baseline|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
385999|NCT00662025|P1|Participant Flow|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386000|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386001|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386002|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386003|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386004|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386005|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386006|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386007|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386026|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386027|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386008|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386009|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386010|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386011|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386012|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386013|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386014|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386015|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386016|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386017|NCT00662025|E1|Reported Event|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
386018|NCT00661999|B4|Baseline|Total|Total of all reporting groups
386019|NCT00661999|B3|Baseline|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386020|NCT00661999|B2|Baseline|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386021|NCT00661999|B1|Baseline|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386022|NCT00661999|P3|Participant Flow|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386023|NCT00661999|P2|Participant Flow|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386024|NCT00661999|P1|Participant Flow|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386025|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386029|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386030|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386031|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386032|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386033|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386034|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386035|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386036|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386037|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386038|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386039|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386040|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386041|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386042|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386043|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386044|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386045|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386046|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386047|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386048|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386049|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386050|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386051|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386052|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386053|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386054|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386055|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386056|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386057|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386546|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386058|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386059|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386060|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386061|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386062|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386063|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386064|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386065|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386066|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386067|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386068|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386069|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386070|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386071|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386072|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386073|NCT00661999|E3|Reported Event|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386074|NCT00661999|E2|Reported Event|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386075|NCT00661999|E1|Reported Event|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
386076|NCT00661960|B4|Baseline|Total|Total of all reporting groups
386077|NCT00661960|B3|Baseline|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
386078|NCT00661960|B2|Baseline|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
386079|NCT00661960|B1|Baseline|Negative Volunteers|HIV Negative volunteers
386080|NCT00661960|P3|Participant Flow|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
386081|NCT00661960|P2|Participant Flow|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
386082|NCT00661960|P1|Participant Flow|Negative Volunteers|HIV Negative volunteers
386083|NCT00661960|O3|Outcome|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
386084|NCT00661960|O2|Outcome|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
386085|NCT00661960|O1|Outcome|Negative Volunteers|HIV Negative volunteers
386086|NCT00661960|E3|Reported Event|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
386087|NCT00661960|E2|Reported Event|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
386088|NCT00661960|E1|Reported Event|Negative Volunteers|HIV Negative volunteers
386089|NCT00661895|B3|Baseline|Total|Total of all reporting groups
386090|NCT00661895|B2|Baseline|Control|No intervention
386162|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386547|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386091|NCT00661895|B1|Baseline|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
386092|NCT00661895|P2|Participant Flow|Control|No intervention
386093|NCT00661895|P1|Participant Flow|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
386094|NCT00661895|O2|Outcome|Control|Free antihypertensive medications, basic hypertension education and usual clinical care.
386095|NCT00661895|O1|Outcome|Intervention|Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
386096|NCT00661895|E2|Reported Event|Control|No intervention
386097|NCT00661895|E1|Reported Event|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
386098|NCT00661830|B3|Baseline|Total|Total of all reporting groups
386099|NCT00661830|B2|Baseline|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386100|NCT00661830|B1|Baseline|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386101|NCT00661830|P2|Participant Flow|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386102|NCT00661830|P1|Participant Flow|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386103|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386104|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386105|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386106|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386107|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386108|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386109|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386110|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386111|NCT00661830|E2|Reported Event|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
386112|NCT00661830|E1|Reported Event|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
386113|NCT00661778|B1|Baseline|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386114|NCT00661778|P1|Participant Flow|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386115|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386116|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386117|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386163|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386118|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386119|NCT00661778|E1|Reported Event|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
386120|NCT00661726|B1|Baseline|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
386121|NCT00661726|P1|Participant Flow|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
386122|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386123|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386124|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386125|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386126|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386127|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386128|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386129|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386130|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386131|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386132|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386133|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386134|NCT00661726|E1|Reported Event|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
386135|NCT00661713|B9|Baseline|Total|Total of all reporting groups
386136|NCT00661713|B8|Baseline|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386137|NCT00661713|B7|Baseline|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386138|NCT00661713|B6|Baseline|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386139|NCT00661713|B5|Baseline|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386140|NCT00661713|B4|Baseline|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386141|NCT00661713|B3|Baseline|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386142|NCT00661713|B2|Baseline|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386143|NCT00661713|B1|Baseline|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386144|NCT00661713|P8|Participant Flow|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386145|NCT00661713|P7|Participant Flow|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386146|NCT00661713|P6|Participant Flow|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386147|NCT00661713|P5|Participant Flow|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386148|NCT00661713|P4|Participant Flow|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386149|NCT00661713|P3|Participant Flow|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386150|NCT00661713|P2|Participant Flow|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386151|NCT00661713|P1|Participant Flow|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386152|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386153|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386154|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386155|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386156|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386157|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386158|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386159|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386160|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386161|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386766|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386165|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386166|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386167|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386168|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386169|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386170|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386171|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386172|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386173|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386174|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386175|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386176|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386177|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386178|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386179|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386180|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386181|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386182|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386183|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386184|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386185|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386186|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386187|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386188|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386189|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386190|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386191|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386192|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386193|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386194|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386195|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386196|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386197|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386198|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386199|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386200|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386201|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386202|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386203|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386204|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386205|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386206|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386207|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386208|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386209|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386210|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386211|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386212|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386213|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386214|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386215|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386216|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386217|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386218|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386219|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386220|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386221|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386222|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386223|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386224|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386225|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386226|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386227|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386228|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386229|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386230|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386231|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386232|NCT00661713|E8|Reported Event|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
386233|NCT00661713|E7|Reported Event|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
386234|NCT00661713|E6|Reported Event|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
386235|NCT00661713|E5|Reported Event|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
386236|NCT00661713|E4|Reported Event|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
386237|NCT00661713|E3|Reported Event|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
386238|NCT00661713|E2|Reported Event|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
386239|NCT00661713|E1|Reported Event|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
386240|NCT00661687|B1|Baseline|PureVision Contact Lens|PureVision Contact Lens Original Design and New Design.
386241|NCT00661687|P1|Participant Flow|PureVision Contact Lens|PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
386242|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
386243|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
386244|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
386245|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
386246|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
386247|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
386248|NCT00661687|E2|Reported Event|PureVision Contact Lens Design #2|PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
386249|NCT00661687|E1|Reported Event|PureVision Contact Lens Design #1|PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
386250|NCT00661661|B3|Baseline|Total|Total of all reporting groups
386251|NCT00661661|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386252|NCT00661661|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386253|NCT00661661|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386254|NCT00661661|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386255|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386256|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386257|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386258|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386259|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386260|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386261|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386262|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386263|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386264|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386265|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386266|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386267|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386268|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386269|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386270|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386367|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386767|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386271|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386272|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386273|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386274|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386275|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386276|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386277|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386278|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386279|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386280|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386281|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386282|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386283|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386284|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386285|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386286|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386462|NCT00661427|O2|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
386768|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386287|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386288|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386289|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386290|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386291|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386292|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386293|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386294|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386295|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386296|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386297|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386298|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386299|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386300|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386301|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386302|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386463|NCT00661427|O1|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
386464|NCT00661427|E2|Reported Event|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
386303|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386304|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386305|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386306|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386307|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386308|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386309|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386310|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386311|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386312|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386313|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386314|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386315|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386316|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386317|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386318|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386465|NCT00661427|E1|Reported Event|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
386769|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386319|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386320|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386321|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386322|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386323|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386324|NCT00661661|E3|Reported Event|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
386325|NCT00661661|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
386326|NCT00661661|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
386327|NCT00661622|B3|Baseline|Total|Total of all reporting groups
386328|NCT00661622|B2|Baseline|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386329|NCT00661622|B1|Baseline|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386330|NCT00661622|P2|Participant Flow|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386331|NCT00661622|P1|Participant Flow|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386332|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386333|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386334|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386335|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386548|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386336|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386337|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386338|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386339|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386340|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386341|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386342|NCT00661622|E2|Reported Event|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
386343|NCT00661622|E1|Reported Event|Immunoembolization|Liver embolization treatment with injection of GM-CSF.
386344|NCT00661609|B1|Baseline|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386345|NCT00661609|P1|Participant Flow|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386346|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386347|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386348|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386349|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386350|NCT00661609|E1|Reported Event|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
386351|NCT00661583|B4|Baseline|Total|Total of all reporting groups
386352|NCT00661583|B3|Baseline|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386353|NCT00661583|B2|Baseline|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386354|NCT00661583|B1|Baseline|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386355|NCT00661583|P3|Participant Flow|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386356|NCT00661583|P2|Participant Flow|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386357|NCT00661583|P1|Participant Flow|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386358|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386359|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386360|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386361|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386362|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386363|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386364|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386365|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386366|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386368|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386369|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386370|NCT00661583|E3|Reported Event|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
386371|NCT00661583|E2|Reported Event|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
386372|NCT00661583|E1|Reported Event|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
386373|NCT00661570|B1|Baseline|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386374|NCT00661570|P1|Participant Flow|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386375|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386376|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386377|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386378|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386379|NCT00661570|E1|Reported Event|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
386380|NCT00661544|B1|Baseline|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
386381|NCT00661544|P1|Participant Flow|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
386382|NCT00661544|O1|Outcome|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
386383|NCT00661544|E1|Reported Event|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
386384|NCT00661505|B1|Baseline|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386385|NCT00661505|P1|Participant Flow|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386386|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386387|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386388|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386466|NCT00661388|B1|Baseline|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386502|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386389|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386390|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386391|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386392|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386393|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386394|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386395|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386396|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386397|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386398|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386467|NCT00661388|P1|Participant Flow|C.E.R.A|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
386541|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386399|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386400|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386401|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386402|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386403|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386404|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386405|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386406|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386407|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386408|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386468|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386501|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386683|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386409|NCT00661505|E1|Reported Event|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
386410|NCT00661492|B3|Baseline|Total|Total of all reporting groups
386411|NCT00661492|B2|Baseline|Arm 2|Novantrone
386412|NCT00661492|B1|Baseline|Arm 1|Novantrone+Erbitux
386413|NCT00661492|P2|Participant Flow|Arm 2|Novantrone
386414|NCT00661492|P1|Participant Flow|Arm 1|Novantrone+Erbitux
386415|NCT00661492|O2|Outcome|Arm 2|Novantrone
386416|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386417|NCT00661492|O2|Outcome|Arm 2|Novantrone
386418|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386419|NCT00661492|O2|Outcome|Arm 2|Novantrone
386420|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386421|NCT00661492|O2|Outcome|Arm 2|Novantrone
386422|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386423|NCT00661492|O2|Outcome|Arm 2|Novantrone
386424|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386425|NCT00661492|O2|Outcome|Arm 2|Novantrone
386426|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386427|NCT00661492|O2|Outcome|Arm 2|Novantrone
386428|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386429|NCT00661492|O2|Outcome|Arm 2|Novantrone
386430|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
386431|NCT00661492|E2|Reported Event|Arm 2|Novantrone
386432|NCT00661492|E1|Reported Event|Arm 1|Novantrone+Erbitux
386433|NCT00661479|B5|Baseline|Total|Total of all reporting groups
386434|NCT00661479|B4|Baseline|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386435|NCT00661479|B3|Baseline|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386436|NCT00661479|B2|Baseline|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386437|NCT00661479|B1|Baseline|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386438|NCT00661479|P4|Participant Flow|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386439|NCT00661479|P3|Participant Flow|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386440|NCT00661479|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386441|NCT00661479|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386442|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386443|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386444|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386445|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386446|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386447|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386448|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386449|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386450|NCT00661479|E3|Reported Event|100 µg Brimonidine Tartrate Implant Groups A and B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386451|NCT00661479|E2|Reported Event|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386452|NCT00661479|E1|Reported Event|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
386453|NCT00661453|B1|Baseline|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
386454|NCT00661453|P1|Participant Flow|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
386455|NCT00661453|O1|Outcome|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
386456|NCT00661453|E1|Reported Event|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
386457|NCT00661427|B3|Baseline|Total|Total of all reporting groups
386458|NCT00661427|B2|Baseline|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
386459|NCT00661427|B1|Baseline|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
386460|NCT00661427|P2|Participant Flow|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
386461|NCT00661427|P1|Participant Flow|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
386757|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386469|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386470|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386471|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386472|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386473|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386474|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386475|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386476|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386477|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386478|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386479|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386480|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386481|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386482|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386483|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386484|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386485|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386486|NCT00661388|E1|Reported Event|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
386487|NCT00661362|B3|Baseline|Total|Total of all reporting groups
386488|NCT00661362|B2|Baseline|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386489|NCT00661362|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386490|NCT00661362|P2|Participant Flow|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386491|NCT00661362|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386492|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386493|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386494|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386495|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386496|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386497|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386498|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386499|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386500|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386503|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386504|NCT00661362|E2|Reported Event|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
386505|NCT00661362|E1|Reported Event|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
386506|NCT00661193|B3|Baseline|Total|Total of all reporting groups
386507|NCT00661193|B2|Baseline|Arm II|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.~carboplatin: given IV~erlotinib hydrochloride: given orally~paclitaxel: given IV"
386508|NCT00661193|B1|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: given orally"
386509|NCT00661193|P2|Participant Flow|Arm II|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.~carboplatin: given IV~erlotinib hydrochloride: given orally~paclitaxel: given IV"
386510|NCT00661193|P1|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: given orally"
386511|NCT00661193|O2|Outcome|Arm II|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.~carboplatin: given IV~erlotinib hydrochloride: given orally~paclitaxel: given IV"
386512|NCT00661193|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: given orally"
386513|NCT00661193|O2|Outcome|Arm II|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.~carboplatin: given IV~erlotinib hydrochloride: given orally~paclitaxel: given IV"
386514|NCT00661193|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: given orally"
386515|NCT00661193|E2|Reported Event|Arm II|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
386516|NCT00661193|E1|Reported Event|Arm I|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
386517|NCT00661089|B3|Baseline|Total|Total of all reporting groups
386518|NCT00661089|B2|Baseline|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
386519|NCT00661089|B1|Baseline|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
386520|NCT00661089|P2|Participant Flow|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
386521|NCT00661089|P1|Participant Flow|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
386522|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
386523|NCT00661089|O1|Outcome|Placebo|Group received saline injections intramuscularly of equivalent volume
386524|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
386525|NCT00661089|O1|Outcome|Placebo|Group recieved saline injections intramuscularly of equivalent volume
386526|NCT00661089|E2|Reported Event|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
386527|NCT00661089|E1|Reported Event|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
386528|NCT00660985|B3|Baseline|Total|Total of all reporting groups
386529|NCT00660985|B2|Baseline|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386530|NCT00660985|B1|Baseline|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386531|NCT00660985|P2|Participant Flow|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386532|NCT00660985|P1|Participant Flow|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386533|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386534|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386535|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386536|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386537|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386538|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386539|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386540|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386549|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386550|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386551|NCT00660985|E2|Reported Event|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
386552|NCT00660985|E1|Reported Event|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
386553|NCT00660907|B3|Baseline|Total|Total of all reporting groups
386554|NCT00660907|B2|Baseline|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386555|NCT00660907|B1|Baseline|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386556|NCT00660907|P2|Participant Flow|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386557|NCT00660907|P1|Participant Flow|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386558|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386559|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386560|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386561|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386562|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386563|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386564|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386565|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386566|NCT00660907|E2|Reported Event|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
386567|NCT00660907|E1|Reported Event|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
386568|NCT00660829|B3|Baseline|Total|Total of all reporting groups
386569|NCT00660829|B2|Baseline|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386570|NCT00660829|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386571|NCT00660829|P2|Participant Flow|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386572|NCT00660829|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386573|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386574|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386575|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386576|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386577|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386578|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386579|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386580|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386581|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386582|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386583|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386584|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386585|NCT00660829|E2|Reported Event|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
386586|NCT00660829|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
386587|NCT00660816|B3|Baseline|Total|Total of all reporting groups
386588|NCT00660816|B2|Baseline|Experimental|Alimta or Taxotere and Tarceva
386589|NCT00660816|B1|Baseline|Active Comparator|Alimta or Taxotere alone
386590|NCT00660816|P2|Participant Flow|Experimental|Alimta or Taxotere and Tarceva
386591|NCT00660816|P1|Participant Flow|Active Comparator|Alimta or Taxotere alone
386592|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
386593|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
386594|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
386595|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
386596|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
386597|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
386598|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
386599|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
386600|NCT00660816|E2|Reported Event|Experimental|Alimta or Taxotere and Tarceva
386601|NCT00660816|E1|Reported Event|Active Comparator|Alimta or Taxotere alone
386602|NCT00660699|B1|Baseline|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386603|NCT00660699|P1|Participant Flow|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386758|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386604|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386605|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386606|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386607|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386608|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386609|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386610|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386611|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386612|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386613|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386614|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386615|NCT00660699|E1|Reported Event|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
386616|NCT00660660|B3|Baseline|Total|Total of all reporting groups
386617|NCT00660660|B2|Baseline|Placebo|Capsule once daily (QD)
386759|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386618|NCT00660660|B1|Baseline|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386619|NCT00660660|P2|Participant Flow|Placebo|Capsule once daily (QD)
386620|NCT00660660|P1|Participant Flow|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386621|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386622|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386623|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386624|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386625|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386626|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386627|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386628|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386629|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386630|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386631|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386632|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386633|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386634|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386635|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386636|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386637|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386638|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386639|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386640|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386641|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386642|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386643|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386644|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386645|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386646|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386647|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386648|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386649|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386650|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386651|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386652|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386653|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386654|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386655|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386656|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386657|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386658|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386659|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386660|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386661|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386662|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386663|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386664|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386665|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386666|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386667|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386668|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386669|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386670|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386671|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386672|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386673|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386674|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386675|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386676|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386677|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386678|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386679|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386680|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386681|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386682|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386684|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386685|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386686|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386687|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386688|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386689|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386690|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386691|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386692|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386693|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386694|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386695|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386696|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386697|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386698|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386699|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386700|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386701|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386702|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386703|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386704|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386705|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386706|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386707|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386708|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386709|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386710|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386711|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386712|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386713|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
386714|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386715|NCT00660660|E2|Reported Event|Placebo|Capsule once daily (QD)
386716|NCT00660660|E1|Reported Event|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
386717|NCT00660595|B3|Baseline|Total|Total of all reporting groups
386718|NCT00660595|B2|Baseline|Risperdal|Risperidone, oral administration
386719|NCT00660595|B1|Baseline|Seroquel|Quetiapine Prolong, oral administration
386720|NCT00660595|P2|Participant Flow|Risperdal|Risperidone, oral administration
386721|NCT00660595|P1|Participant Flow|Seroquel|Quetiapine Prolong, oral administration
386722|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
386723|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
386724|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
386725|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
386726|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
386727|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
386728|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
386729|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
386730|NCT00660595|E2|Reported Event|Risperdal|Risperidone, oral administration
386731|NCT00660595|E1|Reported Event|Seroquel|Quetiapine Prolong, oral administration
386732|NCT00659490|B4|Baseline|Total|Total of all reporting groups
386733|NCT00659490|B3|Baseline|Naproxen|Naproxen 500mg given pre-surgery
386734|NCT00659490|B2|Baseline|Placebo|Placebo given pre-surgery
386735|NCT00659490|B1|Baseline|AZD1940|AZD1940 800ug given predose
386736|NCT00659490|P3|Participant Flow|Naproxen|Naproxen 500mg given pre-surgery
386737|NCT00659490|P2|Participant Flow|Placebo|Placebo given pre-surgery
386738|NCT00659490|P1|Participant Flow|AZD1940|AZD1940 800ug given predose
386739|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386740|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386741|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386742|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386743|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386744|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386745|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386746|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386747|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386748|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386749|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386750|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386751|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386752|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386753|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386754|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386755|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386756|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386770|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386771|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386772|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386773|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386774|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386775|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386776|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386777|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386778|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386779|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386780|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386781|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386782|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386783|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386784|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386785|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386786|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386787|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386788|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386789|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386790|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386791|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386792|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386793|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386794|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386795|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386796|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386797|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386798|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386799|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386800|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386801|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386802|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
386803|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
386804|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
386805|NCT00659490|E3|Reported Event|Naproxen|Naproxen 500mg given pre-surgery
386806|NCT00659490|E2|Reported Event|Placebo|Placebo given pre-surgery
386807|NCT00659490|E1|Reported Event|AZD1940|AZD1940 800ug given predose
386808|NCT00659438|B3|Baseline|Total|Total of all reporting groups
386809|NCT00659438|B2|Baseline|Placebo|Bicalutamide 150mg + placebo
386810|NCT00659438|B1|Baseline|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386811|NCT00659438|P2|Participant Flow|Placebo|Bicalutamide 150mg + placebo
386812|NCT00659438|P1|Participant Flow|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386813|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386814|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386815|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386816|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386817|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386818|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386819|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386820|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386821|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386822|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386823|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386824|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386825|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386826|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386827|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386828|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386829|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
386830|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386831|NCT00659438|E2|Reported Event|Placebo|Bicalutamide 150mg + placebo
386832|NCT00659438|E1|Reported Event|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
386833|NCT00659373|B3|Baseline|Total|Total of all reporting groups
386834|NCT00659373|B2|Baseline|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation).~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
386835|NCT00659373|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
386836|NCT00659373|P2|Participant Flow|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
386837|NCT00659373|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
386838|NCT00659373|O2|Outcome|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
386839|NCT00659373|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
386840|NCT00659373|E2|Reported Event|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
386841|NCT00659373|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
386842|NCT00659360|B1|Baseline|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386843|NCT00659360|P1|Participant Flow|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386844|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386845|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386846|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386847|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386848|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386849|NCT00659360|E1|Reported Event|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
386850|NCT00659334|B8|Baseline|Total|Total of all reporting groups
386851|NCT00659334|B7|Baseline|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
386852|NCT00659334|B6|Baseline|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
386853|NCT00659334|B5|Baseline|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
386854|NCT00659334|B4|Baseline|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
386855|NCT00659334|B3|Baseline|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
386856|NCT00659334|B2|Baseline|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
386857|NCT00659334|B1|Baseline|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
386858|NCT00659334|P7|Participant Flow|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
386859|NCT00659334|P6|Participant Flow|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
386860|NCT00659334|P5|Participant Flow|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
386861|NCT00659334|P4|Participant Flow|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
386862|NCT00659334|P3|Participant Flow|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
386863|NCT00659334|P2|Participant Flow|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
386864|NCT00659334|P1|Participant Flow|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
386865|NCT00659334|O7|Outcome|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
386866|NCT00659334|O6|Outcome|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
386867|NCT00659334|O5|Outcome|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
386868|NCT00659334|O4|Outcome|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
386869|NCT00659334|O3|Outcome|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
386870|NCT00659334|O2|Outcome|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
386871|NCT00659334|O1|Outcome|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
386872|NCT00659334|E7|Reported Event|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
386873|NCT00659334|E6|Reported Event|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
386874|NCT00659334|E5|Reported Event|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
386875|NCT00659334|E4|Reported Event|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
386876|NCT00659334|E3|Reported Event|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
386877|NCT00659334|E2|Reported Event|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
386878|NCT00659334|E1|Reported Event|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
386879|NCT00660543|B1|Baseline|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
386880|NCT00660543|P1|Participant Flow|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
386881|NCT00660543|O1|Outcome|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).
386882|NCT00660543|O3|Outcome|Gadoteridol Leakage Correction|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
386928|NCT00660400|B1|Baseline|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386883|NCT00660543|O2|Outcome|Gadoteridol|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
386884|NCT00660543|O1|Outcome|Ferumoxytol|Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
386885|NCT00660543|E3|Reported Event|Gadoteridol With Leakage Correction|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
386886|NCT00660543|E2|Reported Event|Gadoteridol|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
386887|NCT00660543|E1|Reported Event|Ferumoxytol|Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
386888|NCT00660517|B5|Baseline|Total|Total of all reporting groups
386889|NCT00660517|B4|Baseline|Placebo|nasal spray
386890|NCT00660517|B3|Baseline|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386891|NCT00660517|B2|Baseline|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386892|NCT00660517|B1|Baseline|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386893|NCT00660517|P4|Participant Flow|Placebo|nasal spray
386894|NCT00660517|P3|Participant Flow|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386895|NCT00660517|P2|Participant Flow|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386896|NCT00660517|P1|Participant Flow|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386897|NCT00660517|O4|Outcome|Placebo|nasal spray
386898|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386899|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386900|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386901|NCT00660517|O4|Outcome|Placebo|placebo nasal spray one spray per nostril two times a day
386902|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386903|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386904|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386905|NCT00660517|O4|Outcome|Placebo|nasal spray
386906|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386907|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386908|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386909|NCT00660517|E4|Reported Event|Placebo|nasal spray
386910|NCT00660517|E3|Reported Event|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
386911|NCT00660517|E2|Reported Event|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
386912|NCT00660517|E1|Reported Event|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
386913|NCT00660504|B3|Baseline|Total|Total of all reporting groups
386914|NCT00660504|B2|Baseline|Etoposide, Anticancer, Injection|
386915|NCT00660504|B1|Baseline|Amrubicin, Anticancer, Injection|
386916|NCT00660504|P2|Participant Flow|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
386917|NCT00660504|P1|Participant Flow|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
386918|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
386919|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
386920|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
386921|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
386922|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
386923|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
386924|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
386925|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
386926|NCT00660504|E2|Reported Event|Etoposide, Anticancer, Injection|
386927|NCT00660504|E1|Reported Event|Amrubicin, Anticancer, Injection|
386929|NCT00660400|P1|Participant Flow|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386930|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386931|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386932|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386933|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386934|NCT00660400|E1|Reported Event|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
386935|NCT00660387|B3|Baseline|Total|Total of all reporting groups
386936|NCT00660387|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386937|NCT00660387|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386938|NCT00660387|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386939|NCT00660387|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386940|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386941|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386942|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386943|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386944|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386945|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386946|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386947|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386948|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386949|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386950|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386951|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386952|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386953|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
387149|NCT00659789|B3|Baseline|Total|Total of all reporting groups
386954|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386955|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386956|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386957|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386958|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386959|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386960|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386961|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386962|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386963|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386964|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386965|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386966|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386967|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386968|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386969|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386970|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386971|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386972|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386973|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386974|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386975|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386976|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386977|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386978|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386979|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386980|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386981|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386982|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386983|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386984|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386985|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386986|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386987|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386988|NCT00660387|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
386989|NCT00660387|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
386990|NCT00660348|B3|Baseline|Total|Total of all reporting groups
386991|NCT00660348|B2|Baseline|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
386992|NCT00660348|B1|Baseline|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
386993|NCT00660348|P2|Participant Flow|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
386994|NCT00660348|P1|Participant Flow|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
386995|NCT00660348|O2|Outcome|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
386996|NCT00660348|O1|Outcome|Morphine|"morphine given traditionally (IV, pill, patch). This is standard of care dosing.~morphine sulfate: This is morphine given in the traditional methods."
386997|NCT00660348|E2|Reported Event|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
387305|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
386998|NCT00660348|E1|Reported Event|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
386999|NCT00660309|B3|Baseline|Total|Total of all reporting groups
387000|NCT00660309|B2|Baseline|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387001|NCT00660309|B1|Baseline|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387002|NCT00660309|P2|Participant Flow|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387003|NCT00660309|P1|Participant Flow|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387004|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387005|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387006|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387007|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387008|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387009|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387010|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387011|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387012|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387013|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387014|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387015|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387016|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387017|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387018|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387019|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387020|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387021|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387022|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387023|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387024|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387025|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387026|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387027|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387028|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387029|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387030|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387031|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387032|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387033|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387034|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387035|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387036|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387037|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387038|NCT00660309|E3|Reported Event|Irbesartan 300 mg|Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
387039|NCT00660309|E2|Reported Event|Aliskiren 300 mg|Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
387040|NCT00660309|E1|Reported Event|Captopril 25 mg|On Day 1 participants received a single oral dose of 25 mg captopril.
387041|NCT00660192|B3|Baseline|Total|Total of all reporting groups
387042|NCT00660192|B2|Baseline|Botox|
387043|NCT00660192|B1|Baseline|Placebo|
387044|NCT00660192|P2|Participant Flow|Botox|Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
387045|NCT00660192|P1|Participant Flow|Placebo|Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.
387046|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
387047|NCT00660192|O1|Outcome|Placebo|Inactive Saline
387048|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
387049|NCT00660192|O1|Outcome|Placebo|Inactive Saline
387050|NCT00660192|E2|Reported Event|Botox|
387051|NCT00660192|E1|Reported Event|Saline|
387052|NCT00660179|B4|Baseline|Total|Total of all reporting groups
387053|NCT00660179|B3|Baseline|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387054|NCT00660179|B2|Baseline|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387055|NCT00660179|B1|Baseline|Placebo|Matching ACT-064992 placebo tablet, once daily
387056|NCT00660179|P3|Participant Flow|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387057|NCT00660179|P2|Participant Flow|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387058|NCT00660179|P1|Participant Flow|Placebo|Matching ACT-064992 placebo tablet, once daily
387059|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387060|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387061|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387062|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387063|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387064|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387065|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387066|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387067|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387068|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387069|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387070|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387071|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387072|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387073|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387074|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387075|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387076|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387077|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387078|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387079|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387080|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387081|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387082|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387083|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387084|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387085|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
387086|NCT00660179|E3|Reported Event|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
387087|NCT00660179|E2|Reported Event|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
387088|NCT00660179|E1|Reported Event|Placebo|Matching ACT-064992 placebo tablet, once daily
387089|NCT00660075|B3|Baseline|Total|Total of all reporting groups
387090|NCT00660075|B2|Baseline|Placebo|Placebo for 6 weeks
387091|NCT00660075|B1|Baseline|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
387092|NCT00660075|P2|Participant Flow|Sitagliptin First, Then Placebo|Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.
387306|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
387093|NCT00660075|P1|Participant Flow|Placebo First, Then Sitagliptin|Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
387094|NCT00660075|O2|Outcome|Sitagliptin 100 mg/d|Sitagliptin 100 mg/d for 6 weeks
387095|NCT00660075|O1|Outcome|Placebo|Placebo for 6 weeks
387096|NCT00660075|E2|Reported Event|Placebo|Placebo for 6 weeks
387097|NCT00660075|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
387098|NCT00660049|B1|Baseline|Open Label Single Arm Study|Eligible participants
387099|NCT00660049|P1|Participant Flow|SNaP Application|"This is an open label pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
387100|NCT00660049|O1|Outcome|Open Label Single Arm Study|All participants who use the device
387101|NCT00660049|E1|Reported Event|Eligible Participants|"This is an open label pilot study of SNaP Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
387102|NCT00660023|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387103|NCT00660023|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
387104|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387105|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387106|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387107|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387108|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387109|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387110|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387111|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387112|NCT00660023|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
387113|NCT00660010|B1|Baseline|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387114|NCT00660010|P1|Participant Flow|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387150|NCT00659789|B2|Baseline|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
390293|NCT00648895|B3|Baseline|Total|Total of all reporting groups
387115|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387116|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387117|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387118|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387119|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387120|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387121|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387122|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387123|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387124|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387125|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387126|NCT00660010|E1|Reported Event|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
387127|NCT00659945|B3|Baseline|Total|Total of all reporting groups
387128|NCT00659945|B2|Baseline|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
387129|NCT00659945|B1|Baseline|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
387130|NCT00659945|P2|Participant Flow|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
387131|NCT00659945|P1|Participant Flow|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
387132|NCT00659945|O2|Outcome|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
387133|NCT00659945|O1|Outcome|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
387134|NCT00659945|E2|Reported Event|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
387135|NCT00659945|E1|Reported Event|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
387136|NCT00659815|B3|Baseline|Total|Total of all reporting groups
387137|NCT00659815|B2|Baseline|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387138|NCT00659815|B1|Baseline|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387139|NCT00659815|P2|Participant Flow|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387140|NCT00659815|P1|Participant Flow|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387141|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387142|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387143|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387144|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387145|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387146|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387147|NCT00659815|E2|Reported Event|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
387148|NCT00659815|E1|Reported Event|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
387151|NCT00659789|B1|Baseline|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387152|NCT00659789|P2|Participant Flow|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387153|NCT00659789|P1|Participant Flow|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387154|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387155|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387156|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387157|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387158|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387159|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387160|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387161|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387162|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387163|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387164|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387165|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387166|NCT00659789|E2|Reported Event|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
387167|NCT00659789|E1|Reported Event|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
387168|NCT00659737|B3|Baseline|Total|Total of all reporting groups
387169|NCT00659737|B2|Baseline|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
387170|NCT00659737|B1|Baseline|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
387171|NCT00659737|P2|Participant Flow|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
387172|NCT00659737|P1|Participant Flow|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
387173|NCT00659737|O2|Outcome|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
387174|NCT00659737|O1|Outcome|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
387175|NCT00659737|E2|Reported Event|Scopolamine|"Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.~Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days"
387176|NCT00659737|E1|Reported Event|Aprepiatnt|"Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.~Emend (Aprepitant) + Placebo: 40mg tablet"
387177|NCT00659724|B1|Baseline|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
387178|NCT00659724|P1|Participant Flow|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
387179|NCT00659724|O3|Outcome|Optiflux F200NR|
387180|NCT00659724|O2|Outcome|Optiflux F180NR|
387181|NCT00659724|O1|Outcome|Revaclear MAX|
387182|NCT00659724|O3|Outcome|Optiflux F200NR|
387183|NCT00659724|O2|Outcome|Optiflux F180NR|
387184|NCT00659724|O1|Outcome|Revaclear MAX|
387185|NCT00659724|O3|Outcome|Optiflux F200NR|
387186|NCT00659724|O2|Outcome|Optiflux F180NR|
387187|NCT00659724|O1|Outcome|Revaclear MAX|
387188|NCT00659724|O3|Outcome|Optiflux F200NR|
387189|NCT00659724|O2|Outcome|Optiflux F180NR|
387190|NCT00659724|O1|Outcome|Revaclear MAX|
387191|NCT00659724|O3|Outcome|Optiflux F200NR|
387192|NCT00659724|O2|Outcome|Optiflux F180NR|
387193|NCT00659724|O1|Outcome|Revaclear MAX|
387194|NCT00659724|E1|Reported Event|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
387195|NCT00659607|B1|Baseline|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387271|NCT00659165|B1|Baseline|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387196|NCT00659607|P1|Participant Flow|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387197|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
387198|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
387199|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387200|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387201|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387202|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387203|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387204|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387205|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387206|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387207|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387208|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387209|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387210|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387211|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
387212|NCT00659607|E1|Reported Event|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
387213|NCT00659581|B1|Baseline|Telmisartan|
387214|NCT00659581|P1|Participant Flow|Telmisartan|
387215|NCT00659581|O1|Outcome|Telmisartan|
387216|NCT00659581|O1|Outcome|Telmisartan|
387217|NCT00659581|O1|Outcome|Telmisartan|
387218|NCT00659581|O1|Outcome|Telmisartan|
387219|NCT00659581|O1|Outcome|Telmisartan|
387220|NCT00659581|O1|Outcome|Telmisartan|
387221|NCT00659581|O1|Outcome|Telmisartan|
387222|NCT00659581|O1|Outcome|Telmisartan|
387223|NCT00659581|O1|Outcome|Telmisartan|
387224|NCT00659581|E1|Reported Event|Telmisartan|
387225|NCT00659529|B1|Baseline|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
387226|NCT00659529|P1|Participant Flow|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
387227|NCT00659529|O1|Outcome|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
387228|NCT00659529|E1|Reported Event|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
387229|NCT00659295|B3|Baseline|Total|Total of all reporting groups
387230|NCT00659295|B2|Baseline|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387231|NCT00659295|B1|Baseline|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387232|NCT00659295|P2|Participant Flow|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387233|NCT00659295|P1|Participant Flow|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387234|NCT00659295|O2|Outcome|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387235|NCT00659295|O1|Outcome|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387236|NCT00659295|E2|Reported Event|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387237|NCT00659295|E1|Reported Event|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
387238|NCT00659269|B3|Baseline|Total|Total of all reporting groups
387239|NCT00659269|B2|Baseline|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
387240|NCT00659269|B1|Baseline|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
387241|NCT00659269|P2|Participant Flow|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
387242|NCT00659269|P1|Participant Flow|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
387243|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387244|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387245|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387246|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387247|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387248|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, abraxane, 1200-1800"
387249|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387250|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387251|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387252|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387253|NCT00659269|O2|Outcome|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387254|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387255|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387256|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387257|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387258|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387259|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387260|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387261|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387262|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
387263|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387264|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
387265|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400"
387266|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
387267|NCT00659269|E2|Reported Event|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
387268|NCT00659269|E1|Reported Event|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
387269|NCT00659165|B3|Baseline|Total|Total of all reporting groups
387270|NCT00659165|B2|Baseline|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387272|NCT00659165|P2|Participant Flow|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387273|NCT00659165|P1|Participant Flow|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387274|NCT00659165|O2|Outcome|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387275|NCT00659165|O1|Outcome|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387276|NCT00659165|E2|Reported Event|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387277|NCT00659165|E1|Reported Event|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
387278|NCT00659061|B3|Baseline|Total|Total of all reporting groups
387279|NCT00659061|B2|Baseline|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387280|NCT00659061|B1|Baseline|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387281|NCT00659061|P2|Participant Flow|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387282|NCT00659061|P1|Participant Flow|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387283|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387284|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387285|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387286|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387287|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387288|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387289|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387290|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387291|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387292|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387293|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387294|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387295|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387296|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387297|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387298|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
387299|NCT00658996|B1|Baseline|Entire Study Population|Population enrolled at start of study
387300|NCT00658996|P2|Participant Flow|Focus Dailies Toric First, Then SofLens DD Toric|Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
387301|NCT00658996|P1|Participant Flow|SofLens DD Toric First, Then Focus Dailies Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
387302|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
387303|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
387304|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
387307|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
387308|NCT00658996|E2|Reported Event|Ciba Vision Toric Lens|Ciba Vision Focus Dailies Toric Lens
387309|NCT00658996|E1|Reported Event|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
387310|NCT00658814|B3|Baseline|Total|Total of all reporting groups
387311|NCT00658814|B2|Baseline|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387312|NCT00658814|B1|Baseline|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387313|NCT00658814|P2|Participant Flow|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387314|NCT00658814|P1|Participant Flow|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387315|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387316|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387317|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387318|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387319|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387320|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
387321|NCT00658814|O3|Outcome|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
387322|NCT00658814|O2|Outcome|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
387323|NCT00658814|O1|Outcome|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
387324|NCT00658814|E3|Reported Event|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
387325|NCT00658814|E2|Reported Event|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
387610|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387326|NCT00658814|E1|Reported Event|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
387327|NCT00658788|B1|Baseline|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
387328|NCT00658788|P1|Participant Flow|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
387329|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387330|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387331|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387332|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387333|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387334|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387335|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387336|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387337|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387338|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387339|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387340|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387341|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387342|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387343|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387344|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387345|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387346|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387347|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387348|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387349|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387350|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387351|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387352|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387353|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387354|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387355|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387356|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387357|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387358|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387359|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387360|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387361|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387362|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387363|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387364|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387365|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387366|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387367|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387368|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387369|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387370|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387371|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387372|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387373|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387374|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387375|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387376|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387377|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
387378|NCT00658788|O1|Outcome|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
387379|NCT00658788|E1|Reported Event|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
387380|NCT00658775|B3|Baseline|Total|Total of all reporting groups
387381|NCT00658775|B2|Baseline|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387382|NCT00658775|B1|Baseline|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387383|NCT00658775|P2|Participant Flow|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387384|NCT00658775|P1|Participant Flow|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387385|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387386|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387387|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387388|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387389|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387390|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387391|NCT00658775|E2|Reported Event|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
387392|NCT00658775|E1|Reported Event|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
387393|NCT00658723|B3|Baseline|Total|Total of all reporting groups
387394|NCT00658723|B2|Baseline|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
387395|NCT00658723|B1|Baseline|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
387396|NCT00658723|P3|Participant Flow|Fibrin Pad Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
387397|NCT00658723|P2|Participant Flow|SURGICEL™ Randomized|"SURGICEL™ Absorbable Hemostat~SURGICEL™: Absorbable hemostat"
387398|NCT00658723|P1|Participant Flow|Fibrin Pad Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387399|NCT00658723|O2|Outcome|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
387400|NCT00658723|O1|Outcome|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
387401|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
387402|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387403|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387404|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
387405|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387406|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387407|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
387408|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387409|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387410|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
387411|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387412|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387413|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
387414|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387415|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387416|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
387417|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387418|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387419|NCT00658723|O3|Outcome|Fibrin Pad - Non-Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
387420|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
387421|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
387422|NCT00658723|E2|Reported Event|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
387423|NCT00658723|E1|Reported Event|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
387424|NCT00658697|B1|Baseline|Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT)|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387425|NCT00658697|P1|Participant Flow|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387446|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387447|NCT00658684|O1|Outcome|Total|All subjects
387448|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387449|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
388829|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
387426|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387427|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387428|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387429|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387430|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387431|NCT00658697|E1|Reported Event|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
387432|NCT00658684|B4|Baseline|Total|Total of all reporting groups
387433|NCT00658684|B3|Baseline|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387434|NCT00658684|B2|Baseline|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387435|NCT00658684|B1|Baseline|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387436|NCT00658684|P4|Participant Flow|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387437|NCT00658684|P3|Participant Flow|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387438|NCT00658684|P2|Participant Flow|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387439|NCT00658684|P1|Participant Flow|Total|All subjects
387440|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387441|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387442|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387443|NCT00658684|O1|Outcome|Total|All subjects
387444|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387445|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
388830|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
387450|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387451|NCT00658684|O1|Outcome|Total|All subjects
387452|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387453|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387454|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387455|NCT00658684|O1|Outcome|Total|All subjects
387456|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387457|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387458|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387459|NCT00658684|O1|Outcome|Total|All subjects
387460|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387461|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387462|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387463|NCT00658684|O1|Outcome|Total|All subjects
387464|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387465|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387466|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387467|NCT00658684|O1|Outcome|Total|All subjects
387468|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387469|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387470|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387471|NCT00658684|O1|Outcome|Total|All subjects
387472|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387473|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387474|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387475|NCT00658684|O1|Outcome|Total|All subjects
387476|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387477|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387478|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387479|NCT00658684|O1|Outcome|Total|All subjects
387480|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387481|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387482|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387483|NCT00658684|O1|Outcome|Total|All subjects
387484|NCT00658684|E4|Reported Event|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
387485|NCT00658684|E3|Reported Event|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
387486|NCT00658684|E2|Reported Event|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
387487|NCT00658684|E1|Reported Event|Total|All subjects
387488|NCT00658658|B6|Baseline|Total|Total of all reporting groups
387489|NCT00658658|B5|Baseline|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387490|NCT00658658|B4|Baseline|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387491|NCT00658658|B3|Baseline|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387492|NCT00658658|B2|Baseline|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
390526|NCT00646399|E1|Reported Event|Pagibaximab|
387493|NCT00658658|B1|Baseline|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387494|NCT00658658|P5|Participant Flow|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387495|NCT00658658|P4|Participant Flow|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387496|NCT00658658|P3|Participant Flow|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387497|NCT00658658|P2|Participant Flow|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387498|NCT00658658|P1|Participant Flow|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387499|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387500|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387501|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387502|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387503|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387504|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387505|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387506|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387507|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387508|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387509|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387510|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387511|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387512|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387513|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387514|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387564|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387515|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387516|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387517|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387518|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387519|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387520|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387521|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387522|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387523|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387524|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387525|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387526|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387527|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387528|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387529|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387530|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387531|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387532|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387533|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387534|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387535|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387536|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387565|NCT00658632|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387537|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387538|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387539|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387540|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387541|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387542|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387543|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387544|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387545|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387546|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387547|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387548|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387549|NCT00658658|E5|Reported Event|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387550|NCT00658658|E4|Reported Event|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387551|NCT00658658|E3|Reported Event|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387552|NCT00658658|E2|Reported Event|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387553|NCT00658658|E1|Reported Event|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
387554|NCT00658632|B3|Baseline|Total|Total of all reporting groups
387555|NCT00658632|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387556|NCT00658632|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387557|NCT00658632|P2|Participant Flow|Rabeprazole (RAB) Extended Release (ER) 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387558|NCT00658632|P1|Participant Flow|Esomeprazole (ESO) 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387559|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387560|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387561|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387562|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387563|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387566|NCT00658632|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387567|NCT00658619|B6|Baseline|Total|Total of all reporting groups
387568|NCT00658619|B5|Baseline|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387569|NCT00658619|B4|Baseline|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387570|NCT00658619|B3|Baseline|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387571|NCT00658619|B2|Baseline|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387572|NCT00658619|B1|Baseline|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387573|NCT00658619|P5|Participant Flow|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387574|NCT00658619|P4|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387575|NCT00658619|P3|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387576|NCT00658619|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387577|NCT00658619|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387578|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387579|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
387580|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387581|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387582|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
387583|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387584|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387585|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
387586|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387587|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387588|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
387589|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387590|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387591|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387592|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387593|NCT00658619|E3|Reported Event|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
387594|NCT00658619|E2|Reported Event|200 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387595|NCT00658619|E1|Reported Event|400 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
387596|NCT00658606|B3|Baseline|Total|Total of all reporting groups
387597|NCT00658606|B2|Baseline|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387598|NCT00658606|B1|Baseline|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387599|NCT00658606|P2|Participant Flow|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387600|NCT00658606|P1|Participant Flow|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387601|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387602|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387603|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387604|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387605|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387606|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387607|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387608|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387609|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387611|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387612|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387613|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387614|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387615|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387616|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387617|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387618|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387619|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387620|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387621|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387622|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387623|NCT00658606|E2|Reported Event|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
387624|NCT00658606|E1|Reported Event|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
387625|NCT00658567|B4|Baseline|Total|Total of all reporting groups
387626|NCT00658567|B3|Baseline|20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
387627|NCT00658567|B2|Baseline|10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
387628|NCT00658567|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
387629|NCT00658567|P3|Participant Flow|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
387630|NCT00658567|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
387631|NCT00658567|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
387632|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
387633|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
387634|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
387635|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
387636|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
387637|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
387638|NCT00658567|E3|Reported Event|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
387639|NCT00658567|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
387640|NCT00658567|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
387641|NCT00658541|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
387642|NCT00658541|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
387643|NCT00658541|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
387644|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
387645|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
387646|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
387647|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
387648|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
387649|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
387650|NCT00658541|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
387893|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
387651|NCT00658541|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
387652|NCT00658528|B3|Baseline|Total|Total of all reporting groups
387653|NCT00658528|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387654|NCT00658528|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387655|NCT00658528|P2|Participant Flow|RAB ER 50 mg|Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387656|NCT00658528|P1|Participant Flow|ESO 40 mg|Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
387657|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387658|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387659|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387660|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387661|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387662|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387663|NCT00658528|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
387664|NCT00658528|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
387665|NCT00658411|B1|Baseline|All Patients|Deferoxamine prior to stem cells
387666|NCT00658411|P1|Participant Flow|All Patients|Deferoxamine for >= 2 weeks prior to stem cells
387667|NCT00658411|O4|Outcome|Overall Survival (Deferoxamine)|Patients who received Deferoxamine and have relapsed and is alive at 1 year.
387668|NCT00658411|O3|Outcome|Disease-Free Survival (Deferoxamine)|Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.
387669|NCT00658411|O2|Outcome|Relapse (Deferoxamine)|Patients who received Deferoxamine and relapsed post transplant at 1 year.
387670|NCT00658411|O1|Outcome|Transplant-Related Mortality (Deferoxamine)|Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.
387671|NCT00658411|O1|Outcome|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
387672|NCT00658411|E1|Reported Event|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
387673|NCT00658385|B1|Baseline|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
387674|NCT00658385|P1|Participant Flow|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
387675|NCT00658385|O1|Outcome|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
387676|NCT00658385|E1|Reported Event|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
387677|NCT00658333|B3|Baseline|Total|Total of all reporting groups
387678|NCT00658333|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387679|NCT00658333|B1|Baseline|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387680|NCT00658333|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387681|NCT00658333|P1|Participant Flow|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387682|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387683|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387684|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387685|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387686|NCT00658333|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387687|NCT00658333|E1|Reported Event|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
387688|NCT00658320|B3|Baseline|Total|Total of all reporting groups
387689|NCT00658320|B2|Baseline|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387690|NCT00658320|B1|Baseline|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387691|NCT00658320|P2|Participant Flow|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387692|NCT00658320|P1|Participant Flow|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387693|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387694|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387725|NCT00657709|P5|Participant Flow|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
387726|NCT00657709|P4|Participant Flow|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387695|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387696|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387697|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387698|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387699|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387700|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387701|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387702|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387703|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387704|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387727|NCT00657709|P3|Participant Flow|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387728|NCT00657709|P2|Participant Flow|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387894|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
387705|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387706|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387707|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387708|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387709|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387710|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387711|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
387712|NCT00658320|E2|Reported Event|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
387713|NCT00658320|E1|Reported Event|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
387714|NCT00658138|B1|Baseline|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
387715|NCT00658138|P1|Participant Flow|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
387716|NCT00658138|O2|Outcome|Scotchbond 1XT|3M ESPE Adper Scotchbond 1XT
387717|NCT00658138|O1|Outcome|Scotchbond SE|3M ESPE Adper Scotchbond SE
387718|NCT00658138|E1|Reported Event|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
387719|NCT00657709|B6|Baseline|Total|Total of all reporting groups
387720|NCT00657709|B5|Baseline|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
387721|NCT00657709|B4|Baseline|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387722|NCT00657709|B3|Baseline|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387723|NCT00657709|B2|Baseline|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387724|NCT00657709|B1|Baseline|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387729|NCT00657709|P1|Participant Flow|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387730|NCT00657709|O2|Outcome|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
387731|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387732|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387733|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387734|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387735|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ(Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387736|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387737|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387738|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387739|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ(Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387740|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387741|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ(Lot1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387742|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387743|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387744|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387745|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387746|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387747|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387748|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387749|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection fo rMenB+OMV NZ (Lot1, or Lot 2, or Lot 3) at 2, 4, and 6months of age concomitantly with the routinely administered infant vaccines.
387750|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387751|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387752|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387753|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387754|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387755|NCT00657709|O4|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387756|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387757|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387758|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387759|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387760|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387761|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387762|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387763|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387764|NCT00657709|E5|Reported Event|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
387765|NCT00657709|E4|Reported Event|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
387766|NCT00657709|E3|Reported Event|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387767|NCT00657709|E2|Reported Event|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
390527|NCT00646282|B3|Baseline|Total|Total of all reporting groups
387768|NCT00657709|E1|Reported Event|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
387769|NCT00657657|B1|Baseline|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387770|NCT00657657|P1|Participant Flow|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387771|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387772|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387773|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387774|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387775|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387776|NCT00657657|E1|Reported Event|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
387777|NCT00657553|B3|Baseline|Total|Total of all reporting groups
387778|NCT00657553|B2|Baseline|Observation Arm|Patients will be observed for progress over the course of three years.
387779|NCT00657553|B1|Baseline|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
387780|NCT00657553|P2|Participant Flow|Observation Arm|Patients will be observed for progress over the course of three years.
387781|NCT00657553|P1|Participant Flow|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
387782|NCT00657553|O2|Outcome|Observation Arm|Patients will be observed for progress over the course of three years.
387783|NCT00657553|O1|Outcome|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
387784|NCT00657553|E2|Reported Event|Observation Arm|Patients will be observed for progress over the course of three years.
387785|NCT00657553|E1|Reported Event|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
387786|NCT00657371|B1|Baseline|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
387787|NCT00657371|P1|Participant Flow|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
387788|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
387789|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
387790|NCT00657371|E1|Reported Event|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
387791|NCT00657358|B1|Baseline|Lidocaine|Healthy Volunteers receiving Lidocaine
387792|NCT00657358|P1|Participant Flow|Lidocaine|Healthy Volunteers receiving Lidocaine
387793|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
387794|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
387795|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
387796|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.infused within 20 minutes.
387797|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
387798|NCT00657358|E1|Reported Event|Lidocaine|Healthy Volunteers receiving Lidocaine
387799|NCT00657280|B1|Baseline|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
387800|NCT00657280|P1|Participant Flow|Sitagliptin|There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
387801|NCT00657280|O1|Outcome|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
387802|NCT00657280|E1|Reported Event|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
387803|NCT00657267|B1|Baseline|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387804|NCT00657267|P1|Participant Flow|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387805|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387806|NCT00657267|O2|Outcome|Complete Response|Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387807|NCT00657267|O1|Outcome|Partial Response|Partial Responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387808|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
391471|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
387809|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
387810|NCT00657267|E1|Reported Event|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets
387811|NCT00657150|B3|Baseline|Total|Total of all reporting groups
387812|NCT00657150|B2|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
387813|NCT00657150|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
387814|NCT00657150|P2|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
387815|NCT00657150|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
387816|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387817|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387818|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387819|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387820|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387821|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387822|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387823|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387824|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387825|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387826|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387827|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387828|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387829|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387830|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387831|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387832|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387833|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387834|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387835|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387836|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387837|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387838|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
387839|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
387840|NCT00657150|E2|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
387841|NCT00657150|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
387842|NCT00657046|B4|Baseline|Total|Total of all reporting groups
387843|NCT00657046|B3|Baseline|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387844|NCT00657046|B2|Baseline|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387845|NCT00657046|B1|Baseline|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387846|NCT00657046|P3|Participant Flow|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387847|NCT00657046|P2|Participant Flow|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387848|NCT00657046|P1|Participant Flow|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387849|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387850|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387851|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387852|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387853|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387854|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387855|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387856|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387857|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
388831|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
387858|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387859|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387860|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387861|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387862|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387863|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387864|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387865|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387866|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387867|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387868|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387869|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387870|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387871|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387872|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387873|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387874|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387875|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387876|NCT00657046|E3|Reported Event|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387877|NCT00657046|E2|Reported Event|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387878|NCT00657046|E1|Reported Event|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
387879|NCT00657020|B1|Baseline|All Randomized Participants|All randomized participants who receive study treatments.
387880|NCT00657020|P2|Participant Flow|Placebo Lozenge Then 4 mg Nicotine Lozenge|Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.
387881|NCT00657020|P1|Participant Flow|4 mg Nicotine Lozenge Then Placebo Lozenge|Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
387882|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
387883|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
387884|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
387885|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
387886|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
387887|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
387888|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
387889|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
387890|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
387891|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
387892|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
388832|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
387895|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
387896|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
387897|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
387898|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
387899|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
387900|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
387901|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
387902|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
387903|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
387904|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
387905|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
387906|NCT00657020|E2|Reported Event|Placebo Lozenge|Participants in safety population received placebo lozenge.
387907|NCT00657020|E1|Reported Event|Nicotine Lozenge|Participants in safety population received 4 mg of nicotine lozenge.
387908|NCT00656968|B3|Baseline|Total|Total of all reporting groups
387909|NCT00656968|B2|Baseline|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
387910|NCT00656968|B1|Baseline|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
387911|NCT00656968|P2|Participant Flow|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
387912|NCT00656968|P1|Participant Flow|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
387913|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
387914|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
387915|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
387916|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
387917|NCT00656968|E2|Reported Event|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
387918|NCT00656968|E1|Reported Event|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
387919|NCT00656916|B3|Baseline|Total|Total of all reporting groups
387920|NCT00656916|B2|Baseline|Observation|Comparator group, no intervention.
387921|NCT00656916|B1|Baseline|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
387922|NCT00656916|P2|Participant Flow|Observation|Comparator group, no intervention.
387923|NCT00656916|P1|Participant Flow|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
387924|NCT00656916|O2|Outcome|Observation|Comparator group, no intervention.
387925|NCT00656916|O1|Outcome|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
387926|NCT00656916|E2|Reported Event|Observation|Comparator group, no intervention.
387927|NCT00656916|E1|Reported Event|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
387928|NCT00656851|B3|Baseline|Total|Total of all reporting groups
387929|NCT00656851|B2|Baseline|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387930|NCT00656851|B1|Baseline|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387931|NCT00656851|P2|Participant Flow|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387932|NCT00656851|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387933|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387934|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387935|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387936|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387937|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387938|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387939|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387940|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387941|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387942|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387943|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387944|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387945|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387946|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387947|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387948|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387949|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387950|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387951|NCT00656851|E2|Reported Event|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
387952|NCT00656851|E1|Reported Event|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
387953|NCT00656799|B1|Baseline|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387954|NCT00656799|P1|Participant Flow|Sugammadex|Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex
387955|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387956|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387957|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387958|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387959|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387960|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387961|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387962|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387963|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387964|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387965|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387966|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387967|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387968|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387969|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387970|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387971|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387972|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387973|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387974|NCT00656799|E1|Reported Event|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
387975|NCT00656669|B1|Baseline|Overall Study|These patients are for the patients who were into the trial.
387976|NCT00656669|P1|Participant Flow|Segment Information|This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
387977|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who were in the paclitaxel plus sunitinib segment
387978|NCT00656669|O1|Outcome|AC Dosing|Patients who finished the AC dosing segment
387979|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who finished the paclitaxel plus sunitinib segment
387980|NCT00656669|O1|Outcome|Sunitinib Monotherapy|Patients who completed the Sunitinib monotherapy segment
387981|NCT00656669|E3|Reported Event|AC Dosing|4 cycles (8 weeks) of neoadjuvant treatment with AC.
387982|NCT00656669|E2|Reported Event|Paclitaxel/Sunitinib|4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
387983|NCT00656669|E1|Reported Event|Single Agent Sunitinib|Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
387984|NCT00656656|B1|Baseline|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
387985|NCT00656656|P1|Participant Flow|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
387986|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
387987|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
387988|NCT00656656|E1|Reported Event|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
388084|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
387989|NCT00656617|B1|Baseline|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387990|NCT00656617|P1|Participant Flow|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387991|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387992|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387993|NCT00656617|E2|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 2)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387994|NCT00656617|E1|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 1)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
387995|NCT00656474|B1|Baseline|GLYC-101 and Placebo|Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
387996|NCT00656474|P1|Participant Flow|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
387997|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
387998|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
387999|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
388000|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
388001|NCT00656474|E1|Reported Event|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
388002|NCT00656448|B3|Baseline|Total|Total of all reporting groups
388003|NCT00656448|B2|Baseline|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
388004|NCT00656448|B1|Baseline|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
388005|NCT00656448|P2|Participant Flow|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
388006|NCT00656448|P1|Participant Flow|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
388007|NCT00656448|O2|Outcome|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
388008|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
388009|NCT00656448|O2|Outcome|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
388010|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
388011|NCT00656448|E2|Reported Event|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
388012|NCT00656448|E1|Reported Event|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
388013|NCT00656370|B1|Baseline|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
388014|NCT00656370|P1|Participant Flow|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
388015|NCT00656370|O1|Outcome|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
388016|NCT00656370|O2|Outcome|LR Infusion Group|Maximal post baseline increase in VAS score for LR infusions.
388017|NCT00656370|O1|Outcome|NS Infusion Group|Maximal post baseline increase VAS score for NS infusion.
388048|NCT00656136|E2|Reported Event|Afatinib 50 mg/Day|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388018|NCT00656370|E1|Reported Event|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
388019|NCT00656201|B3|Baseline|Total|Total of all reporting groups
388020|NCT00656201|B2|Baseline|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
388021|NCT00656201|B1|Baseline|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
388022|NCT00656201|P2|Participant Flow|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
388023|NCT00656201|P1|Participant Flow|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
388024|NCT00656201|O2|Outcome|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
388025|NCT00656201|O1|Outcome|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
388026|NCT00656201|E2|Reported Event|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
388027|NCT00656201|E1|Reported Event|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
388028|NCT00656175|B3|Baseline|Total|Total of all reporting groups
388029|NCT00656175|B2|Baseline|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
388030|NCT00656175|B1|Baseline|Immediate|Immediate switch of PI or NNRTI to Raltegravir
388031|NCT00656175|P2|Participant Flow|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
388032|NCT00656175|P1|Participant Flow|Immediate|Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
388033|NCT00656175|O2|Outcome|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
388034|NCT00656175|O1|Outcome|Immediate|Immediate switch of PI or NNRTI to Raltegravir
388035|NCT00656175|E2|Reported Event|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
388036|NCT00656175|E1|Reported Event|Immediate|Immediate switch of PI or NNRTI to Raltegravir
388037|NCT00656136|B3|Baseline|Total|Total of all reporting groups
388038|NCT00656136|B2|Baseline|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388039|NCT00656136|B1|Baseline|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388040|NCT00656136|P2|Participant Flow|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388041|NCT00656136|P1|Participant Flow|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388042|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388043|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388044|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388045|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388046|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
388047|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388194|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388195|NCT00655746|E1|Reported Event|BMS-354825 + Omeprazole|
388049|NCT00656136|E1|Reported Event|Placebo|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
388050|NCT00656084|B1|Baseline|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388051|NCT00656084|P1|Participant Flow|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388052|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388053|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388054|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388055|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388056|NCT00656084|E1|Reported Event|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
388057|NCT00656058|B1|Baseline|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388058|NCT00656058|P1|Participant Flow|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388059|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388060|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388061|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388062|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388063|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388064|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388065|NCT00656058|E1|Reported Event|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
388066|NCT00655889|B1|Baseline|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
388067|NCT00655889|P1|Participant Flow|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
388068|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
388069|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
388070|NCT00655889|E1|Reported Event|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
388071|NCT00655863|B4|Baseline|Total|Total of all reporting groups
388072|NCT00655863|B3|Baseline|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388073|NCT00655863|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388074|NCT00655863|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388075|NCT00655863|P3|Participant Flow|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388076|NCT00655863|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388077|NCT00655863|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388078|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388079|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388080|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388081|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388082|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388083|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388085|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388086|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388087|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388088|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388089|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388090|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388091|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388092|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388093|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388094|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388095|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388096|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388097|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388098|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388099|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388100|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388101|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388102|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388103|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388104|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388105|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388106|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388107|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388108|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388109|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388110|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388111|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388112|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388113|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388114|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388115|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388116|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388117|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388118|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388119|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388120|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388121|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388122|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388123|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388124|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388125|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388126|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388127|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388128|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388129|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388130|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388131|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388132|NCT00655863|E3|Reported Event|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
388133|NCT00655863|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388134|NCT00655863|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
388135|NCT00655824|B1|Baseline|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388136|NCT00655824|P1|Participant Flow|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course (TC). The remaining TCs were given at individualized time intervals when a clinical response had been achieved following the previous TC and a subsequent worsening in disease activity had been observed. For the remaining TCs, the interval between the TCs was at least 16 weeks from the first infusion in the previous TC irrespective of progression in disease activity. After each TC, participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next TC. A maximum of 9 TCs were allowed. After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
388137|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388138|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388139|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388196|NCT00655733|B3|Baseline|Total|Total of all reporting groups
388197|NCT00655733|B2|Baseline|Placebo|Placebo
388198|NCT00655733|B1|Baseline|HMPL004|HMPL004 1200mg/d
388199|NCT00655733|P2|Participant Flow|Placebo|Placebo
388200|NCT00655733|P1|Participant Flow|HMPL004|HMPL004 1200mg/d
388201|NCT00655733|O2|Outcome|Placebo|Placebo
388202|NCT00655733|O1|Outcome|HMPL004|HMPL004 1200mg/d
388140|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388141|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388142|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388143|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388144|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388145|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388146|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388147|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388203|NCT00655733|E2|Reported Event|Placebo|Placebo
388204|NCT00655733|E1|Reported Event|HMPL004|HMPL004 1200mg/d
388289|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388148|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388149|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388150|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388151|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388152|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388153|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388154|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388155|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388205|NCT00655668|B1|Baseline|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388833|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388156|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388157|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388158|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388159|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388160|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388161|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388162|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388163|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388206|NCT00655668|P1|Participant Flow|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388834|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388164|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388165|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388166|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388167|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388168|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388169|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388170|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388171|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388207|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388835|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388172|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388173|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388174|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388175|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388176|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388177|NCT00655824|E2|Reported Event|Ofatumumab 700 mg IV Infusion: Follow-up Period|After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
388178|NCT00655824|E1|Reported Event|Ofatumumab 700 mg IV Infusion: Treatment Period|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treament course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
388179|NCT00655746|B1|Baseline|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
388180|NCT00655746|P1|Participant Flow|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
388181|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388182|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388183|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388184|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388185|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388186|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388187|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388188|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388189|NCT00655746|O4|Outcome|All Participants|
388190|NCT00655746|O3|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388191|NCT00655746|O2|Outcome|Omeprazole (Days 2-5)|40-mg oral omeprazole
388192|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
388193|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
388208|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388209|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388210|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388211|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388212|NCT00655668|E1|Reported Event|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
388213|NCT00655642|B5|Baseline|Total|Total of all reporting groups
388214|NCT00655642|B4|Baseline|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
388215|NCT00655642|B3|Baseline|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
388216|NCT00655642|B2|Baseline|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
388217|NCT00655642|B1|Baseline|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
388218|NCT00655642|P4|Participant Flow|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
388219|NCT00655642|P3|Participant Flow|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
388220|NCT00655642|P2|Participant Flow|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
388221|NCT00655642|P1|Participant Flow|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
388222|NCT00655642|O4|Outcome|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
388223|NCT00655642|O3|Outcome|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
388224|NCT00655642|O2|Outcome|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
388225|NCT00655642|O1|Outcome|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
388226|NCT00655642|E4|Reported Event|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
388227|NCT00655642|E3|Reported Event|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
388228|NCT00655642|E2|Reported Event|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
388229|NCT00655642|E1|Reported Event|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
388230|NCT00655629|B3|Baseline|Total|Total of all reporting groups
388231|NCT00655629|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388232|NCT00655629|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388233|NCT00655629|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388234|NCT00655629|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388235|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388236|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388237|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388238|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388239|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388240|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388241|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388242|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388243|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388244|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388245|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388246|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388247|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388248|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388249|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388250|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388251|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388252|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388253|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388254|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388255|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388256|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388257|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388258|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388259|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388260|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388261|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388262|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388263|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388264|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388265|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388266|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388267|NCT00655629|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388268|NCT00655629|E1|Reported Event|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
388269|NCT00655564|B1|Baseline|Group 1|
388270|NCT00655564|P1|Participant Flow|Group 1|
388271|NCT00655564|O1|Outcome|Group 1|
388272|NCT00655564|O1|Outcome|Group 1|
388273|NCT00655564|E1|Reported Event|Group 1|
388274|NCT00655551|B4|Baseline|Total|Total of all reporting groups
388275|NCT00655551|B3|Baseline|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388276|NCT00655551|B2|Baseline|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388277|NCT00655551|B1|Baseline|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388278|NCT00655551|P3|Participant Flow|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388279|NCT00655551|P2|Participant Flow|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388280|NCT00655551|P1|Participant Flow|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388281|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388282|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388283|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388284|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388285|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388286|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388287|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388288|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388290|NCT00655551|E3|Reported Event|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
388291|NCT00655551|E2|Reported Event|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
388292|NCT00655551|E1|Reported Event|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
388293|NCT00655486|B1|Baseline|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
388294|NCT00655486|P1|Participant Flow|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
388295|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
388296|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
388297|NCT00655486|E1|Reported Event|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
388298|NCT00655356|B3|Baseline|Total|Total of all reporting groups
388299|NCT00655356|B2|Baseline|Placebo|Patients treated with placebo solution
388300|NCT00655356|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
388301|NCT00655356|P2|Participant Flow|Placebo|Patients treated with placebo solution
388302|NCT00655356|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
388303|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
388304|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
388305|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
388306|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
388307|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
388308|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
388309|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
388310|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
388311|NCT00655356|E2|Reported Event|Placebo|Patients treated with placebo solution.
388312|NCT00655356|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
388313|NCT00655083|B3|Baseline|Total|Total of all reporting groups
388314|NCT00655083|B2|Baseline|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388315|NCT00655083|B1|Baseline|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388316|NCT00655083|P2|Participant Flow|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388317|NCT00655083|P1|Participant Flow|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388318|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388319|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388320|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388321|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388322|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388323|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388324|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388325|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388326|NCT00655083|E2|Reported Event|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
388327|NCT00655083|E1|Reported Event|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
388328|NCT00654992|B3|Baseline|Total|Total of all reporting groups
388329|NCT00654992|B2|Baseline|Placebo Group|received normal saline intraveously following induction of anesthesia
388330|NCT00654992|B1|Baseline|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
388331|NCT00654992|P2|Participant Flow|Placebo Group|received normal saline intraveously following induction of anesthesia
388332|NCT00654992|P1|Participant Flow|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
388333|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
388334|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
388335|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
388336|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
388337|NCT00654953|B4|Baseline|Total|Total of all reporting groups
388338|NCT00654953|B3|Baseline|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
388339|NCT00654953|B2|Baseline|Active Group: Sertraline Alone|sertraline (200 mg/day)
388340|NCT00654953|B1|Baseline|Placebo Group|Placebo capsules
388341|NCT00654953|P3|Participant Flow|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
388342|NCT00654953|P2|Participant Flow|Active Group: Sertraline Alone|sertraline (200 mg/day)
388343|NCT00654953|P1|Participant Flow|Placebo Group|Placebo capsules
388344|NCT00654953|O3|Outcome|Sertraline Plus Gabapentin|
388345|NCT00654953|O2|Outcome|Sertraline|
388346|NCT00654953|O1|Outcome|Placebo|
388347|NCT00654953|E3|Reported Event|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
388348|NCT00654953|E2|Reported Event|Active Group: Sertraline Alone|sertraline (200 mg/day)
388349|NCT00654953|E1|Reported Event|Placebo Group|Placebo capsules
388350|NCT00654940|B3|Baseline|Total|Total of all reporting groups
388463|NCT00654745|E3|Reported Event|Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
388351|NCT00654940|B2|Baseline|Placebo Then Pregabalin|Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
388352|NCT00654940|B1|Baseline|Pregabalin Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
388353|NCT00654940|P2|Participant Flow|Placebo First Then Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
388354|NCT00654940|P1|Participant Flow|Pregabalin First Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
388355|NCT00654940|O2|Outcome|Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
388356|NCT00654940|O1|Outcome|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
388357|NCT00654940|O2|Outcome|Placebo/Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
388358|NCT00654940|O1|Outcome|Pregabalin/Placebo|Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
388359|NCT00654940|O4|Outcome|Period 2: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
388360|NCT00654940|O3|Outcome|Period 2: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
388361|NCT00654940|O2|Outcome|Period 1: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
388362|NCT00654940|O1|Outcome|Period 1: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
388363|NCT00654940|E2|Reported Event|Placebo|Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
388364|NCT00654940|E1|Reported Event|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
388365|NCT00654927|B1|Baseline|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388366|NCT00654927|P1|Participant Flow|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388367|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388368|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388369|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388370|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388371|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388372|NCT00654927|E1|Reported Event|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
388373|NCT00654901|B5|Baseline|Total|Total of all reporting groups
388374|NCT00654901|B4|Baseline|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388375|NCT00654901|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388376|NCT00654901|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388377|NCT00654901|B1|Baseline|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388378|NCT00654901|P4|Participant Flow|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388464|NCT00654745|E2|Reported Event|Start - Amlodipine 5 mg|All participants started trial on Amlodipine 5 mg.
388836|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388379|NCT00654901|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388380|NCT00654901|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388381|NCT00654901|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388382|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388383|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388384|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388385|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388386|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388387|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388388|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388389|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388390|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388391|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388392|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388393|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388394|NCT00654901|E4|Reported Event|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
388395|NCT00654901|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388396|NCT00654901|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388397|NCT00654901|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
388398|NCT00654875|B3|Baseline|Total|Total of all reporting groups
388399|NCT00654875|B2|Baseline|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388400|NCT00654875|B1|Baseline|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388401|NCT00654875|P2|Participant Flow|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388402|NCT00654875|P1|Participant Flow|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388403|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388404|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388405|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388406|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388407|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388408|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388409|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388410|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388411|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388412|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388413|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388414|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388415|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388416|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388417|NCT00654875|E2|Reported Event|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
388418|NCT00654875|E1|Reported Event|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
388419|NCT00654784|B3|Baseline|Total|Total of all reporting groups
388420|NCT00654784|B2|Baseline|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
388421|NCT00654784|B1|Baseline|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
388422|NCT00654784|P2|Participant Flow|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
388423|NCT00654784|P1|Participant Flow|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
388424|NCT00654784|O2|Outcome|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
388425|NCT00654784|O1|Outcome|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
388426|NCT00654784|E2|Reported Event|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
388427|NCT00654784|E1|Reported Event|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
388428|NCT00654745|B1|Baseline|Aml + Olm + Hctz|amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
388429|NCT00654745|P1|Participant Flow|Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide|Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388430|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388431|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388432|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388433|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388434|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388435|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388436|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388437|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388438|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388439|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388440|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388441|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388442|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388443|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388444|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388445|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388446|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388447|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388448|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388449|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388450|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388451|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388452|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388453|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388454|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388455|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388456|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388457|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388458|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388459|NCT00654745|E7|Reported Event|Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
388460|NCT00654745|E6|Reported Event|Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
388461|NCT00654745|E5|Reported Event|Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
388462|NCT00654745|E4|Reported Event|Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
391472|NCT00642694|O2|Outcome|Escitalopram + Placebp|control group
388465|NCT00654745|E1|Reported Event|ALL - Aml + Olm + Hctz|Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
388466|NCT00654654|B1|Baseline|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
388467|NCT00654654|P1|Participant Flow|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
388468|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
388469|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
388470|NCT00654654|E1|Reported Event|Active|Patients treated with autologous human fibroblasts
388471|NCT00654641|B3|Baseline|Total|Total of all reporting groups
388472|NCT00654641|B2|Baseline|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
388473|NCT00654641|B1|Baseline|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
388474|NCT00654641|P2|Participant Flow|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
388475|NCT00654641|P1|Participant Flow|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
388476|NCT00654641|O2|Outcome|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
388477|NCT00654641|O1|Outcome|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
388478|NCT00654641|E2|Reported Event|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
388479|NCT00654641|E1|Reported Event|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
388480|NCT00654628|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388481|NCT00654628|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388482|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388483|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388484|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388485|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388486|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388487|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388488|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388489|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388490|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388491|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388492|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388493|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388494|NCT00654628|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
388495|NCT00654511|B5|Baseline|Total|Total of all reporting groups
388496|NCT00654511|B4|Baseline|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
388497|NCT00654511|B3|Baseline|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
388498|NCT00654511|B2|Baseline|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
388499|NCT00654511|B1|Baseline|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
388500|NCT00654511|P4|Participant Flow|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
388501|NCT00654511|P3|Participant Flow|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
388502|NCT00654511|P2|Participant Flow|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
388503|NCT00654511|P1|Participant Flow|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
388504|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
388505|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
388506|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
388507|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
388508|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram IV|
388509|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram IV|
388510|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram IV|
388511|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram IV|
388512|NCT00654511|E4|Reported Event|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
388513|NCT00654511|E3|Reported Event|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
388514|NCT00654511|E2|Reported Event|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
388515|NCT00654511|E1|Reported Event|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
388516|NCT00654498|B3|Baseline|Total|Total of all reporting groups
388517|NCT00654498|B2|Baseline|Placebo|
388518|NCT00654498|B1|Baseline|Pramipexole|
388519|NCT00654498|P2|Participant Flow|Placebo|1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
388520|NCT00654498|P1|Participant Flow|Pramipexole|4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
388521|NCT00654498|O2|Outcome|Placebo|
388522|NCT00654498|O1|Outcome|Pramipexole|
388523|NCT00654498|O2|Outcome|Placebo|
388524|NCT00654498|O1|Outcome|Pramipexole|
388525|NCT00654498|O2|Outcome|Placebo|
388526|NCT00654498|O1|Outcome|Pramipexole|
388527|NCT00654498|O2|Outcome|Placebo|
388528|NCT00654498|O1|Outcome|Pramipexole|
388529|NCT00654498|O2|Outcome|Placebo|
388530|NCT00654498|O1|Outcome|Pramipexole|
388531|NCT00654498|O2|Outcome|Placebo|
388532|NCT00654498|O1|Outcome|Pramipexole|
388533|NCT00654498|O2|Outcome|Placebo|
388534|NCT00654498|O1|Outcome|Pramipexole|
388535|NCT00654498|O2|Outcome|Placebo|
388536|NCT00654498|O1|Outcome|Pramipexole|
388537|NCT00654498|O2|Outcome|Placebo|
388538|NCT00654498|O1|Outcome|Pramipexole|
388539|NCT00654498|O2|Outcome|Placebo|
388540|NCT00654498|O1|Outcome|Pramipexole|
388541|NCT00654498|O2|Outcome|Placebo|
388542|NCT00654498|O1|Outcome|Pramipexole|
388543|NCT00654498|O2|Outcome|Placebo|
388544|NCT00654498|O1|Outcome|Pramipexole|
388545|NCT00654498|E2|Reported Event|Placebo|
388546|NCT00654498|E1|Reported Event|Pramipexole|
388547|NCT00654420|B5|Baseline|Total|Total of all reporting groups
388548|NCT00654420|B4|Baseline|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388549|NCT00654420|B3|Baseline|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388550|NCT00654420|B2|Baseline|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388551|NCT00654420|B1|Baseline|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388552|NCT00654420|P4|Participant Flow|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388553|NCT00654420|P3|Participant Flow|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388554|NCT00654420|P2|Participant Flow|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388555|NCT00654420|P1|Participant Flow|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388556|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388557|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388558|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388559|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388560|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388561|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388595|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388562|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388563|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388564|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388565|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388566|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388567|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388568|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388569|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388570|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388571|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388572|NCT00654420|E4|Reported Event|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388573|NCT00654420|E3|Reported Event|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
388574|NCT00654420|E2|Reported Event|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388575|NCT00654420|E1|Reported Event|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
388576|NCT00654381|B5|Baseline|Total|Total of all reporting groups
388577|NCT00654381|B4|Baseline|Voglibose|The patients with voglibose at the start of randomised study medication
388578|NCT00654381|B3|Baseline|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388579|NCT00654381|B2|Baseline|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388580|NCT00654381|B1|Baseline|Placebo|The patients with placebo at the start of randomised study medication
388581|NCT00654381|P6|Participant Flow|Voglibose - Voglibose - Linagliptin 10mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
388582|NCT00654381|P5|Participant Flow|Voglibose - Voglibose - Linagliptin 5mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
388583|NCT00654381|P4|Participant Flow|Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg|10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
388584|NCT00654381|P3|Participant Flow|Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg|5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
388585|NCT00654381|P2|Participant Flow|Placebo - Linagliptin 5mg - Linagliptin 10mg|Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
388586|NCT00654381|P1|Participant Flow|Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg|Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
388587|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388588|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388589|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388590|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388591|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
388592|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388593|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388594|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388596|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
388597|NCT00654381|O2|Outcome|Linagliptin 10mg|The patients with linagliptin 10 mg at the start of randomised study medication
388598|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388599|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
388600|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388601|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388602|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388603|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388604|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
388605|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
388606|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388607|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388608|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
388609|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
388610|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
388611|NCT00654381|E8|Reported Event|Linagliptin 10mg (Extension Stage After Voglibose)|
388612|NCT00654381|E7|Reported Event|Linagliptin 5mg (Extension Stage After Voglibose)|
388613|NCT00654381|E6|Reported Event|Voglibose (1st-2nd Stage)|
388614|NCT00654381|E5|Reported Event|Linagliptin 10mg (1st-2nd-Extension Stage)|
388615|NCT00654381|E4|Reported Event|Linagliptin 5mg (1st-2nd-Extension Stage)|
388616|NCT00654381|E3|Reported Event|Linagliptin 10mg (2nd-Extension Stage After Placebo)|
388617|NCT00654381|E2|Reported Event|Linagliptin 5mg (2nd-Extension Stage After Placebo)|
388618|NCT00654381|E1|Reported Event|Placebo (1st Stage)|
388619|NCT00654368|B4|Baseline|Total|Total of all reporting groups
388620|NCT00654368|B3|Baseline|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388621|NCT00654368|B2|Baseline|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388622|NCT00654368|B1|Baseline|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
388623|NCT00654368|P3|Participant Flow|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388624|NCT00654368|P2|Participant Flow|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388625|NCT00654368|P1|Participant Flow|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
388626|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388627|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388628|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388629|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388630|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388631|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388837|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388632|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388633|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388634|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388635|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388636|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388637|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388638|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388639|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388640|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388641|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388642|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388643|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388644|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388645|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388646|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388647|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388648|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388649|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388650|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388651|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388652|NCT00654368|E3|Reported Event|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
388653|NCT00654368|E2|Reported Event|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
388654|NCT00654368|E1|Reported Event|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
388655|NCT00654329|B5|Baseline|Total|Total of all reporting groups
388656|NCT00654329|B4|Baseline|Normal Saline Placebo|Normal saline placebo intranasal
388657|NCT00654329|B3|Baseline|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
388658|NCT00654329|B2|Baseline|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
388659|NCT00654329|B1|Baseline|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
388660|NCT00654329|P4|Participant Flow|Normal Saline Placebo|Normal saline placebo intranasal
388661|NCT00654329|P3|Participant Flow|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
388662|NCT00654329|P2|Participant Flow|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
388663|NCT00654329|P1|Participant Flow|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
388664|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
388665|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
388666|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
388667|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
388668|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
388669|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
388670|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
388671|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
388672|NCT00654329|E4|Reported Event|Normal Saline Placebo|Normal saline placebo intranasal
388673|NCT00654329|E3|Reported Event|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
388674|NCT00654329|E2|Reported Event|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
388675|NCT00654329|E1|Reported Event|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
388676|NCT00654186|B1|Baseline|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388677|NCT00654186|P1|Participant Flow|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388678|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388679|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388680|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388681|NCT00654186|E1|Reported Event|Revlimid Orally for 21 Days|Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
388682|NCT00654147|B3|Baseline|Total|Total of all reporting groups
388683|NCT00654147|B2|Baseline|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388684|NCT00654147|B1|Baseline|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388685|NCT00654147|P2|Participant Flow|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388686|NCT00654147|P1|Participant Flow|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388687|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388688|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388689|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388690|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388691|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388692|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388693|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388694|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388695|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388696|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388697|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388698|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388699|NCT00654147|E2|Reported Event|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
388700|NCT00654147|E1|Reported Event|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
388701|NCT00654095|B1|Baseline|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
388702|NCT00654095|P1|Participant Flow|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
388703|NCT00654095|O1|Outcome|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
388704|NCT00654095|E1|Reported Event|Ezetimibe+Atorvastatin|
388705|NCT00654030|B1|Baseline|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
388706|NCT00654030|P1|Participant Flow|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
388707|NCT00654030|O1|Outcome|1650-G ARM|2 immunizations of 1650-G given 4 weeks apart
388708|NCT00654030|E1|Reported Event|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
388709|NCT00654004|B3|Baseline|Total|Total of all reporting groups
388710|NCT00654004|B2|Baseline|Controls|Subjects do not have a fatty acid oxidation disorder.
388711|NCT00654004|B1|Baseline|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388712|NCT00654004|P2|Participant Flow|Controls|Subjects do not have a fatty acid oxidation disorder.
388713|NCT00654004|P1|Participant Flow|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388714|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
388715|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388716|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
388717|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388718|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
388719|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388720|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
388721|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388722|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
388723|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388724|NCT00654004|E2|Reported Event|Controls|Subjects do not have a fatty acid oxidation disorder.
388725|NCT00654004|E1|Reported Event|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
388726|NCT00653939|B3|Baseline|Total|Total of all reporting groups
388727|NCT00653939|B2|Baseline|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388728|NCT00653939|B1|Baseline|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388729|NCT00653939|P2|Participant Flow|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388730|NCT00653939|P1|Participant Flow|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388731|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388732|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388733|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388734|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388735|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388736|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388737|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388738|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388763|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388739|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388740|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388741|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388742|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388743|NCT00653939|E2|Reported Event|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388744|NCT00653939|E1|Reported Event|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
388745|NCT00653861|B1|Baseline|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
388746|NCT00653861|P1|Participant Flow|Total Study Participants|Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
388747|NCT00653861|O2|Outcome|Juvéderm NLFs|Nasolabial folds on the corresponding side of the face injected with Juvederm
388748|NCT00653861|O1|Outcome|Juvéderm Lidocaine NLFs|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
388749|NCT00653861|O1|Outcome|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
388750|NCT00653861|O2|Outcome|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
388751|NCT00653861|O1|Outcome|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
388752|NCT00653861|E2|Reported Event|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
388753|NCT00653861|E1|Reported Event|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
388754|NCT00653523|B1|Baseline|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
388755|NCT00653523|P1|Participant Flow|Ezetimibe + Simvastatin|"Ezetimibe 10 mg + Simvastatin 20 mg~level below what was specified in inclusion criterion~level >2x upper limit of normal at start of treatment~level >=3x upper limit of normal after start of treatment~did not resolve or improve after dose reduction of simvastatin"
388756|NCT00653523|O1|Outcome|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
388757|NCT00653523|E1|Reported Event|Ezetimibe+Simvastatin|
388758|NCT00653328|B1|Baseline|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388759|NCT00653328|P1|Participant Flow|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388760|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388761|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388762|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388764|NCT00653328|E1|Reported Event|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
388765|NCT00653263|B1|Baseline|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388766|NCT00653263|P1|Participant Flow|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388767|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388768|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388769|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388770|NCT00653263|E1|Reported Event|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
388771|NCT00653224|B3|Baseline|Total|Total of all reporting groups
388772|NCT00653224|B2|Baseline|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388773|NCT00653224|B1|Baseline|Placebo|Matching oral placebo tablet daily for 14 days
388774|NCT00653224|P2|Participant Flow|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388775|NCT00653224|P1|Participant Flow|Placebo|Matching oral placebo tablet daily for 14 days
388776|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388777|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388778|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388779|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388780|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388781|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388782|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388783|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388784|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388785|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388786|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388787|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388788|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388789|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388790|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388791|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388792|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388793|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388794|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388795|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388796|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388797|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388798|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388799|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388800|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388801|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388802|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388803|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388804|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388805|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388806|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388807|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388808|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388809|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388810|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388811|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388812|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388813|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388814|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388815|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388816|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388817|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388818|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388819|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388820|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388821|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388822|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388823|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388824|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388825|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388826|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388827|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388828|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388838|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388839|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388840|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388841|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388842|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388843|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388844|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388845|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388846|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388847|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388848|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388849|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388850|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388851|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388852|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388853|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388854|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388855|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388856|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388857|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388858|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388859|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388860|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388861|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388862|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388863|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388864|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388865|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388866|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388867|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388868|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388869|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388870|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388871|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388872|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388873|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388874|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388875|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388876|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388877|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388878|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388879|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388880|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388881|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388882|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388883|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388884|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388885|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388886|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388887|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388888|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388889|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388890|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388891|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388892|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388893|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388894|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388895|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388896|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388897|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388898|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388899|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388900|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388901|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388902|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388903|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388904|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388905|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388906|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388907|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388908|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388909|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388910|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388911|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388912|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388913|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388914|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388915|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388916|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388917|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388918|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388919|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388920|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388921|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388922|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388923|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388924|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388925|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388926|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388927|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388928|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388929|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388930|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388931|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388932|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388933|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388934|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388935|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388936|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388937|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388938|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388939|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388940|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388941|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388942|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388943|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388944|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388945|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388946|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388947|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388948|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388949|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388950|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388951|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388952|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388953|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388954|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388955|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
388956|NCT00653224|E2|Reported Event|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
388957|NCT00653224|E1|Reported Event|Placebo|Matching oral placebo tablet daily for 14 days
388958|NCT00652145|B3|Baseline|Total|Total of all reporting groups
388959|NCT00652145|B2|Baseline|Maintain Mesalamine Dose|Participants were randomized to maintain their baseline mesalamine dose
388960|NCT00652145|B1|Baseline|Increase Mesalamine Dose|Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
388961|NCT00652145|P2|Participant Flow|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
388962|NCT00652145|P1|Participant Flow|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
388963|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
388964|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
388965|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
388966|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
388967|NCT00652145|O2|Outcome|Maintain Mesalmine Dose|Maintain current mesalamine dose at 2.4 g/day
388968|NCT00652145|O1|Outcome|Increase Mesalamine Dose by 2.4g/Day|"Increase dose of mesalamine by 2.4 gm per day~mesalamine: Increase dose by 2.4gm per day over baseline dose"
388969|NCT00652145|E2|Reported Event|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
388970|NCT00652145|E1|Reported Event|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
388971|NCT00653159|B3|Baseline|Total|Total of all reporting groups
388972|NCT00653159|B2|Baseline|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388973|NCT00653159|B1|Baseline|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388974|NCT00653159|P2|Participant Flow|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388975|NCT00653159|P1|Participant Flow|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388976|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388977|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388978|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388979|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388980|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388981|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388982|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388983|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388984|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388985|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388986|NCT00653159|E2|Reported Event|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
388987|NCT00653159|E1|Reported Event|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
388988|NCT00653133|B3|Baseline|Total|Total of all reporting groups
388989|NCT00653133|B2|Baseline|NSPNB|Stimulator guided nerve block
388990|NCT00653133|B1|Baseline|USPNB|ultrasound imaging guided peripheral nerve block
388991|NCT00653133|P2|Participant Flow|NSPNB|Stimulator guided nerve block
388992|NCT00653133|P1|Participant Flow|USPNB|ultrasound imaging guided peripheral nerve block
388993|NCT00653133|O2|Outcome|NSPNB|Nerve Stimulator guided peripheral nerve block
388994|NCT00653133|O1|Outcome|USPNB|Ultrasound imaging guided peripheral nerve block
388995|NCT00653133|E2|Reported Event|NSPNB|Stimulator guided nerve block
388996|NCT00653133|E1|Reported Event|USPNB|ultrasound imaging guided peripheral nerve block
388997|NCT00653068|B5|Baseline|Total|Total of all reporting groups
388998|NCT00653068|B4|Baseline|Stratum IV|Older children with INI1 mutation only based diagnosis.
388999|NCT00653068|B3|Baseline|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389000|NCT00653068|B2|Baseline|Stratum II|Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
389001|NCT00653068|B1|Baseline|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389002|NCT00653068|P1|Participant Flow|Treatment|"Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.~Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity."
389003|NCT00653068|O1|Outcome|All Patients|Experimental
389004|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389005|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389006|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389007|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389008|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389009|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389010|NCT00653068|E2|Reported Event|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
389011|NCT00653068|E1|Reported Event|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
389012|NCT00652938|B4|Baseline|Total|Total of all reporting groups
389013|NCT00652938|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389014|NCT00652938|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389015|NCT00652938|B1|Baseline|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389016|NCT00652938|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389017|NCT00652938|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389018|NCT00652938|P1|Participant Flow|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389019|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389515|NCT00651118|O1|Outcome|MP29-02|fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
389020|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389021|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389022|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389023|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389024|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389025|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389026|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389027|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389028|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389029|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389030|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389031|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389032|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389033|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389034|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389035|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389036|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389037|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389038|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389039|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389040|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389041|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389042|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389043|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389044|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389045|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389046|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389047|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389048|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389049|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389050|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389051|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389052|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389053|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389054|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389055|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389056|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389057|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389058|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389059|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389060|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389061|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389062|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389063|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389064|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389065|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389066|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389067|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389068|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389069|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389070|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389071|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389072|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389073|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389074|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389075|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389076|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389077|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389078|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389079|NCT00652938|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389080|NCT00652938|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
389081|NCT00652938|E1|Reported Event|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
389082|NCT00652899|B1|Baseline|All Patients Enrolled|This group includes all patients consented to participate in this study.
389083|NCT00652899|P1|Participant Flow|All Patients Enrolled|This group includes all patients consented to participate in this study.
389084|NCT00652899|O2|Outcome|No Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
389085|NCT00652899|O1|Outcome|Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
389086|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
389087|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
389088|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
389089|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
389090|NCT00652899|O1|Outcome|Ovarian/Fallopian Tube/Peritoneal Cancer Patients|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
389091|NCT00652899|E1|Reported Event|All Patients Enrolled|This group includes all patients consented to participate in this study.
389092|NCT00652834|B1|Baseline|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
389093|NCT00652834|P1|Participant Flow|Kidney Transplant Recipients With GI Symptoms|"Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
389094|NCT00652834|O1|Outcome|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
389095|NCT00652834|E1|Reported Event|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
389096|NCT00652626|B8|Baseline|Total|Total of all reporting groups
389097|NCT00652626|B7|Baseline|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389098|NCT00652626|B6|Baseline|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389099|NCT00652626|B5|Baseline|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389100|NCT00652626|B4|Baseline|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389101|NCT00652626|B3|Baseline|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389102|NCT00652626|B2|Baseline|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389103|NCT00652626|B1|Baseline|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389104|NCT00652626|P7|Participant Flow|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389105|NCT00652626|P6|Participant Flow|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389106|NCT00652626|P5|Participant Flow|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389107|NCT00652626|P4|Participant Flow|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389108|NCT00652626|P3|Participant Flow|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389109|NCT00652626|P2|Participant Flow|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389110|NCT00652626|P1|Participant Flow|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389111|NCT00652626|O7|Outcome|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389112|NCT00652626|O6|Outcome|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389113|NCT00652626|O5|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389114|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389115|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389116|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389117|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389118|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389119|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389120|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389121|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389122|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389123|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389124|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389125|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389126|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389127|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389128|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389129|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389130|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389131|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389132|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389133|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389134|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389135|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389136|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389137|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389138|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389139|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389140|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389141|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389142|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389143|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389144|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389145|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389146|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389147|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389148|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389149|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389150|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389151|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389152|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389153|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389154|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389155|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389156|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389157|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389158|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389159|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389160|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389161|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389162|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389163|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389164|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389165|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389516|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
389166|NCT00652626|E7|Reported Event|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389167|NCT00652626|E6|Reported Event|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
389168|NCT00652626|E5|Reported Event|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389169|NCT00652626|E4|Reported Event|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
389170|NCT00652626|E3|Reported Event|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
389171|NCT00652626|E2|Reported Event|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
389172|NCT00652626|E1|Reported Event|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
389173|NCT00652366|B6|Baseline|Total|Total of all reporting groups
389174|NCT00652366|B5|Baseline|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
389175|NCT00652366|B4|Baseline|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389176|NCT00652366|B3|Baseline|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389177|NCT00652366|B2|Baseline|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389178|NCT00652366|B1|Baseline|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389179|NCT00652366|P5|Participant Flow|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
389180|NCT00652366|P4|Participant Flow|G+E: No Rash Non-Eligibl|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389181|NCT00652366|P3|Participant Flow|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389232|NCT00652327|O1|Outcome|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389233|NCT00652327|E2|Reported Event|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389182|NCT00652366|P2|Participant Flow|G+E Standard Dose: Rash Grade Less Than (<) 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389183|NCT00652366|P1|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389184|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389185|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389186|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389187|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389188|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389189|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389190|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389234|NCT00652327|E1|Reported Event|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389235|NCT00652314|B3|Baseline|Total|Total of all reporting groups
391473|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
389191|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389192|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389193|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389194|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389195|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389196|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389197|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389198|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389199|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389236|NCT00652314|B2|Baseline|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389237|NCT00652314|B1|Baseline|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389517|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
389200|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389201|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389202|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389203|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389204|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389205|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389206|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389207|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months
389238|NCT00652314|P2|Participant Flow|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389239|NCT00652314|P1|Participant Flow|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389240|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389241|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389518|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
389208|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389209|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389210|NCT00652366|E5|Reported Event|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
389211|NCT00652366|E4|Reported Event|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389212|NCT00652366|E3|Reported Event|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389213|NCT00652366|E2|Reported Event|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
389214|NCT00652366|E1|Reported Event|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
389215|NCT00652340|B3|Baseline|Total|Total of all reporting groups
389216|NCT00652340|B2|Baseline|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
389217|NCT00652340|B1|Baseline|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
389218|NCT00652340|P2|Participant Flow|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
389219|NCT00652340|P1|Participant Flow|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
389220|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
389221|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
389222|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
389223|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
389224|NCT00652340|E2|Reported Event|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
389225|NCT00652340|E1|Reported Event|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
389226|NCT00652327|B3|Baseline|Total|Total of all reporting groups
389227|NCT00652327|B2|Baseline|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389228|NCT00652327|B1|Baseline|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389229|NCT00652327|P2|Participant Flow|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389230|NCT00652327|P1|Participant Flow|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389231|NCT00652327|O2|Outcome|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
389242|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389243|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389244|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389245|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389246|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389247|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389248|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389249|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389250|NCT00652314|E2|Reported Event|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389251|NCT00652314|E1|Reported Event|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
389252|NCT00652093|B7|Baseline|Total|Total of all reporting groups
389253|NCT00652093|B6|Baseline|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389254|NCT00652093|B5|Baseline|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389255|NCT00652093|B4|Baseline|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389256|NCT00652093|B3|Baseline|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389257|NCT00652093|B2|Baseline|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389258|NCT00652093|B1|Baseline|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389259|NCT00652093|P6|Participant Flow|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389260|NCT00652093|P5|Participant Flow|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389261|NCT00652093|P4|Participant Flow|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389262|NCT00652093|P3|Participant Flow|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389263|NCT00652093|P2|Participant Flow|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389264|NCT00652093|P1|Participant Flow|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389265|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389266|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389267|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389360|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
390292|NCT00648908|E1|Reported Event|Fampridine-SR|Tablets, 10mg twice daily
389268|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389269|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389270|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389271|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389272|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389273|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389274|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389275|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389276|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389277|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389278|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389279|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389280|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389281|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389282|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389283|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389284|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389285|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389286|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389287|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389288|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389289|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389290|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389291|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389292|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389293|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389294|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389295|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389296|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389297|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389298|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389299|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389300|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389301|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389302|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389303|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389304|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389305|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389306|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389307|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389308|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389309|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389310|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389311|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389312|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389313|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389314|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389315|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389316|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389317|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389318|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389319|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389320|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389321|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389322|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389323|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389324|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389325|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389326|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389327|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389328|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389329|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389330|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389331|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389332|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389333|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389334|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389335|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389336|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389337|NCT00652093|E6|Reported Event|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389338|NCT00652093|E5|Reported Event|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389339|NCT00652093|E4|Reported Event|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
389340|NCT00652093|E3|Reported Event|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389341|NCT00652093|E2|Reported Event|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
389342|NCT00652093|E1|Reported Event|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
389343|NCT00652028|B5|Baseline|Total|Total of all reporting groups
389344|NCT00652028|B4|Baseline|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389345|NCT00652028|B3|Baseline|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389346|NCT00652028|B2|Baseline|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389347|NCT00652028|B1|Baseline|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389348|NCT00652028|P4|Participant Flow|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389349|NCT00652028|P3|Participant Flow|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389350|NCT00652028|P2|Participant Flow|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389351|NCT00652028|P1|Participant Flow|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389352|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389353|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389354|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389355|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389356|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389357|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389358|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389359|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389361|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389362|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389363|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389364|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389365|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389366|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389367|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389368|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389369|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389370|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389371|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389372|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389373|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389374|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389375|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389376|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389377|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389378|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389379|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389380|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389381|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389382|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389383|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389384|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389385|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389386|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389387|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389388|NCT00652028|E4|Reported Event|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
389389|NCT00652028|E3|Reported Event|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
389390|NCT00652028|E2|Reported Event|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
389391|NCT00652028|E1|Reported Event|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
389392|NCT00651924|B3|Baseline|Total|Total of all reporting groups
389393|NCT00651924|B2|Baseline|Phase 2|Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
389394|NCT00651924|B1|Baseline|Phase 1|Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
389395|NCT00651924|P2|Participant Flow|Phase 2|Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
389396|NCT00651924|P1|Participant Flow|Phase 1|Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback.
389397|NCT00651924|O2|Outcome|Phase 2|Pilot IVR-based CBT treatment
389398|NCT00651924|O1|Outcome|Phase 1|Qualitative interviews
389399|NCT00651924|E2|Reported Event|Phase 2|Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain
389400|NCT00651924|E1|Reported Event|Phase 1|Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are.
389519|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
389520|NCT00651118|E4|Reported Event|Placebo|placebo nasal spray
389401|NCT00651820|B1|Baseline|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389402|NCT00651820|P1|Participant Flow|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389403|NCT00651820|O2|Outcome|Vehicle Rate of Wound Closure|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389404|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389405|NCT00651820|O2|Outcome|Vehicle Rate to Complete Wound Healing|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389406|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389407|NCT00651820|E1|Reported Event|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
389408|NCT00651755|B1|Baseline|Entire Study Population|Participants randomized to Aprepitant or control (Standard of Care) in Cycle 1 crossover for different treatment in Cycle 2.
389409|NCT00651755|P2|Participant Flow|First No Aprepritant Cycle 1, Then Aprepitant Cycle 2|First No Aprepitant in Cycle 1, then Aprepitant 125 mg oral (PO) Day 1 of Cycle 2 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above].
389410|NCT00651755|P1|Participant Flow|First Aprepitant Cycle 1 Then No Aprepitant Cycle 2|"First Aprepitant with CHOP or R-CHOP (CHOP plus Rituximab 375 mg/m^2 intravenous Day 1) then No Aprepitant in Cycle 2.~Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]."
389411|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389412|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389413|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389414|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389415|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389416|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389417|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389418|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389419|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389420|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389421|NCT00651755|O2|Outcome|Control Group|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
389422|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
389423|NCT00651755|E2|Reported Event|Control|Standard of Care
389424|NCT00651755|E1|Reported Event|Aprepitant|Aprepitant 125 mg oral (PO) Day 1 (Cycle 1 or Cycle 2) to include treated study population.
389425|NCT00651625|B3|Baseline|Total|Total of all reporting groups
389426|NCT00651625|B2|Baseline|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389521|NCT00651118|E3|Reported Event|Azelastine HCl|azelastine HCl nasal spray nasal spray
389522|NCT00651118|E2|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
389523|NCT00651118|E1|Reported Event|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
389427|NCT00651625|B1|Baseline|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389428|NCT00651625|P2|Participant Flow|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389429|NCT00651625|P1|Participant Flow|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389430|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389431|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389432|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389433|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389434|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389435|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389450|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389524|NCT00651040|B3|Baseline|Total|Total of all reporting groups
389436|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389437|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389438|NCT00651625|E2|Reported Event|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389439|NCT00651625|E1|Reported Event|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
389440|NCT00651482|B1|Baseline|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
389441|NCT00651482|P1|Participant Flow|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
389442|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389443|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389444|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389445|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389446|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389447|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389448|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389449|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
389451|NCT00651482|E1|Reported Event|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
389452|NCT00651313|B3|Baseline|Total|Total of all reporting groups
389453|NCT00651313|B2|Baseline|Placebo|Placebo vaginal gel
389454|NCT00651313|B1|Baseline|Active|Lidocaine 10% (150mg) vaginal gel
389455|NCT00651313|P2|Participant Flow|Placebo|Placebo vaginal gel
389456|NCT00651313|P1|Participant Flow|Active|Lidocaine 10% (150mg) vaginal gel
389457|NCT00651313|O2|Outcome|Placebo Gel|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
389458|NCT00651313|O1|Outcome|Lidocaine 10%|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
389459|NCT00651313|E2|Reported Event|Placebo|Placebo vaginal gel
389460|NCT00651313|E1|Reported Event|Active|Lidocaine 10% (150mg) vaginal gel
389461|NCT00651261|B3|Baseline|Total|Total of all reporting groups
389462|NCT00651261|B2|Baseline|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389463|NCT00651261|B1|Baseline|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389464|NCT00651261|P2|Participant Flow|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389465|NCT00651261|P1|Participant Flow|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389466|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389467|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389468|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389469|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389470|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389471|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389472|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389514|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
389473|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389474|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389475|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389476|NCT00651261|E2|Reported Event|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
389477|NCT00651261|E1|Reported Event|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
389478|NCT00651183|B3|Baseline|Total|Total of all reporting groups
389479|NCT00651183|B2|Baseline|Advanced PD|Advanced Parkinson's Disease (PD) patients
389480|NCT00651183|B1|Baseline|Early PD|Early Parkinson's Disease (PD) patients
389481|NCT00651183|P2|Participant Flow|Advanced PD|Advanced Parkinson's Disease (PD) patients
389482|NCT00651183|P1|Participant Flow|Early (PD)|Early Parkinson's Disease (PD) patients
389483|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
389484|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
389485|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
389486|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
389487|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
389488|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
389489|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
389490|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
389491|NCT00651183|E2|Reported Event|Advanced PD|Advanced Parkinson's Disease (PD) patients
389492|NCT00651183|E1|Reported Event|Early PD|Early Parkinson's Disease (PD) patients
389493|NCT00651157|B1|Baseline|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389494|NCT00651157|P1|Participant Flow|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389495|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389496|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389497|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389498|NCT00651157|E1|Reported Event|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
389499|NCT00651118|B5|Baseline|Total|Total of all reporting groups
389500|NCT00651118|B4|Baseline|Placebo|placebo nasal spray
389501|NCT00651118|B3|Baseline|Azelastine HCl|azelastine HCl nasal spray nasal spray
389502|NCT00651118|B2|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
389503|NCT00651118|B1|Baseline|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
389504|NCT00651118|P4|Participant Flow|Placebo|placebo nasal spray
389505|NCT00651118|P3|Participant Flow|Azelastine HCl|azelastine HCl nasal spray nasal spray
389506|NCT00651118|P2|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
389507|NCT00651118|P1|Participant Flow|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
389508|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
389509|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
389510|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
389511|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
389512|NCT00651118|O4|Outcome|Placebo|Placebo nasal spray
389513|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray
389525|NCT00651040|B2|Baseline|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
389526|NCT00651040|B1|Baseline|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
389527|NCT00651040|P2|Participant Flow|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
389528|NCT00651040|P1|Participant Flow|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
389529|NCT00651040|O2|Outcome|Prednison Methotrexate 2|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
389530|NCT00651040|O1|Outcome|Prednison1|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
389531|NCT00651040|E2|Reported Event|2 Prednison Methotrexate|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
389532|NCT00651040|E1|Reported Event|1 Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
389533|NCT00650858|B4|Baseline|Total|Total of all reporting groups
389534|NCT00650858|B3|Baseline|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389535|NCT00650858|B2|Baseline|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389536|NCT00650858|B1|Baseline|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389537|NCT00650858|P3|Participant Flow|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389538|NCT00650858|P2|Participant Flow|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389539|NCT00650858|P1|Participant Flow|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389540|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389541|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389542|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389543|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389544|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389545|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389546|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389547|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389548|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389549|NCT00650858|E3|Reported Event|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
389550|NCT00650858|E2|Reported Event|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
389551|NCT00650858|E1|Reported Event|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
389552|NCT00650845|B3|Baseline|Total|Total of all reporting groups
389553|NCT00650845|B2|Baseline|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389554|NCT00650845|B1|Baseline|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
389555|NCT00650845|P2|Participant Flow|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389556|NCT00650845|P1|Participant Flow|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
389557|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389558|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
389559|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389560|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
389561|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389562|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
389563|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389564|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
389565|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389566|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
389567|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389568|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
389569|NCT00650845|E2|Reported Event|Non-enhanced MRI|non-enhanced MRI: non injected MRI
389570|NCT00650845|E1|Reported Event|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
389571|NCT00650806|B5|Baseline|Total|Total of all reporting groups
389572|NCT00650806|B4|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389573|NCT00650806|B3|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389574|NCT00650806|B2|Baseline|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389575|NCT00650806|B1|Baseline|Placebo|Each patient received matching placebo once daily for 12 weeks.
389576|NCT00650806|P4|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
389577|NCT00650806|P3|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389578|NCT00650806|P2|Participant Flow|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389579|NCT00650806|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 12 weeks.
389580|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389581|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389582|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389583|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389584|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389585|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389586|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389587|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389588|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389589|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389590|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389591|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389592|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389593|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389594|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389595|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389596|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389597|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389598|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389599|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389600|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389601|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389602|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389603|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389604|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389605|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389606|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389607|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389608|NCT00650806|O4|Outcome|Canaglifloziin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389609|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389610|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389611|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
389612|NCT00650806|E4|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389613|NCT00650806|E3|Reported Event|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389614|NCT00650806|E2|Reported Event|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
389615|NCT00650806|E1|Reported Event|Placebo|Each patient received matching placebo once daily for 12 weeks.
389616|NCT00650767|B5|Baseline|Total|Total of all reporting groups
389617|NCT00650767|B4|Baseline|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389618|NCT00650767|B3|Baseline|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389619|NCT00650767|B2|Baseline|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389620|NCT00650767|B1|Baseline|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389621|NCT00650767|P4|Participant Flow|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389622|NCT00650767|P3|Participant Flow|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389623|NCT00650767|P2|Participant Flow|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389624|NCT00650767|P1|Participant Flow|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389625|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389626|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389627|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389628|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389629|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389630|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389631|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389632|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389633|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389634|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389635|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389636|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389637|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389638|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389639|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389640|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389641|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389642|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389643|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389644|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389645|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389646|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389647|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389648|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389649|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389650|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389651|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389652|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389653|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389654|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389655|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389656|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389657|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389658|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389659|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389660|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389661|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389662|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389663|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389664|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389665|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389666|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389667|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389668|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389669|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389670|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389671|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389672|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389673|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389674|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389675|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389676|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389677|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389678|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389679|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389680|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389681|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389682|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389683|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389684|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389685|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389686|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389687|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389688|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389689|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389690|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389691|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389692|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389693|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389694|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389695|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389696|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389697|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389698|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389699|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389700|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389701|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389702|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389703|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389704|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389705|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389706|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389707|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389708|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389709|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389710|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389711|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389712|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389713|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389714|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389715|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389716|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389717|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389718|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389719|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389720|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389721|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389722|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389723|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389724|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389725|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389726|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389727|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389728|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389729|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389730|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389731|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389732|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389733|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389734|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389735|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389736|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389737|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389738|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389739|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389740|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389741|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389742|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389743|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389744|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389745|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389746|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389747|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389748|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389749|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389750|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389751|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389752|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389753|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389754|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389755|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389756|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389757|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389758|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389759|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389760|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389761|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389762|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389763|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389764|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389765|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389766|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389767|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389768|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389769|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389770|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389771|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389772|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389773|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389774|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389775|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389776|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389777|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389778|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389779|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389780|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389781|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389782|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389783|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389784|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389785|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389786|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389787|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389788|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389789|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389790|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389791|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389792|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389793|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389794|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389795|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389796|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389797|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389798|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389799|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389800|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389801|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389802|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389803|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389804|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389805|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389806|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389807|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389808|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389809|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389810|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389811|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389812|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389813|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389814|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389815|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390213|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
389816|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389817|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389818|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389819|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389820|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389821|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389822|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389823|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389824|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389825|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389826|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389827|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389828|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389829|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389830|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389831|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389832|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389833|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389834|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389835|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389836|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389837|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389838|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389839|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389840|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389841|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389842|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389843|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389844|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389845|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389846|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389847|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389848|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389849|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389850|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389851|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389852|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389853|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389854|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389855|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389856|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389857|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389858|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389859|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389860|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389861|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389862|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389863|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389864|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389865|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389866|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389867|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389868|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389869|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389870|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389871|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389872|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389873|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389874|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389875|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389876|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389877|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389878|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389879|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389880|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389881|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389882|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389883|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389884|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389885|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389886|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389887|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389888|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389889|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389890|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389891|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389892|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389893|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389894|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389895|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389896|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389897|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389898|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389899|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389900|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389901|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389902|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389903|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389904|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389905|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389906|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389907|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389908|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389909|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389910|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389911|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389912|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389913|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389914|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389915|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389916|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389917|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389918|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389919|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389920|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389921|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389922|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389923|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389924|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389925|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389926|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389927|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389928|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389929|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389930|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389931|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389932|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389933|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389934|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389935|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389936|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389937|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389938|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389939|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389940|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389941|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389942|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389943|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389944|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389945|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389946|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389947|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389948|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389949|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389950|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389951|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389952|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389953|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389954|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389955|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389956|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389957|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389958|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389959|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389960|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389961|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389962|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389963|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389964|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389965|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389966|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389967|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389968|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389969|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389970|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389971|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390214|NCT00650078|O2|Outcome|Placebo|
389972|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389973|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389974|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389975|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389976|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389977|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389978|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389979|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389980|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389981|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389982|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389983|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389984|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389985|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389986|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389987|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389988|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389989|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389990|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389991|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389992|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389993|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389994|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389995|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389996|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
389997|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389998|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
389999|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390000|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390001|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390002|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390003|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390004|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390005|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390006|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390007|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390008|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390009|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390010|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390011|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390012|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390013|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390014|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390015|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390016|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390017|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390018|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390019|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390020|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390021|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390022|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390023|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390024|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390025|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390026|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390027|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390028|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390029|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390030|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390031|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390032|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390033|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390034|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390035|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390036|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390037|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390038|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390039|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390040|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390041|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390042|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390043|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390044|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390045|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390046|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390047|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390048|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390049|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390050|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390051|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390052|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390053|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390054|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390055|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390056|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390057|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390058|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390059|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390060|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390061|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390062|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390063|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390064|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390065|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390066|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390067|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390068|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390069|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390070|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390071|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390072|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390073|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390074|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390075|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390076|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390077|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390078|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390079|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390080|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390081|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390082|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390083|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390084|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390085|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390086|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390087|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390088|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390089|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390090|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390091|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390092|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390093|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390094|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390095|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390096|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390097|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390098|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390099|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390100|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390101|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390102|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390103|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390104|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390105|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390106|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390107|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390108|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390109|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390110|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390111|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390112|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390113|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390114|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390115|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390116|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390117|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390118|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390119|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390120|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390121|NCT00650767|E4|Reported Event|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390122|NCT00650767|E3|Reported Event|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390123|NCT00650767|E2|Reported Event|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
390124|NCT00650767|E1|Reported Event|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
390125|NCT00650585|B3|Baseline|Total|Total of all reporting groups
390126|NCT00650585|B2|Baseline|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390127|NCT00650585|B1|Baseline|Control Group|School did not receive Project ALERT, a substance use prevention program
390215|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
390216|NCT00650078|E2|Reported Event|Placebo|
390128|NCT00650585|P2|Participant Flow|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390129|NCT00650585|P1|Participant Flow|Control Group|School did not receive Project ALERT, a substance use prevention program
390130|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390131|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390132|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390133|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390134|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390135|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390136|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390137|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390138|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390139|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390140|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390141|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390142|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390143|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390144|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390145|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
390146|NCT00650585|E2|Reported Event|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
390147|NCT00650585|E1|Reported Event|Control Group|School did not receive Project ALERT, a substance use prevention program
390148|NCT00650546|B1|Baseline|Open-labeled Prospective Case Series|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day"
390149|NCT00650546|P1|Participant Flow|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
390150|NCT00650546|O1|Outcome|Individuals Who Recieved Treatment With Exenatide|change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
390151|NCT00650546|O1|Outcome|Treatment With Exenatide|eight adult patients with known type 2 DM and biopsy proven NAFLD
390152|NCT00650546|E1|Reported Event|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
390153|NCT00650260|B3|Baseline|Total|Total of all reporting groups
390154|NCT00650260|B2|Baseline|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390155|NCT00650260|B1|Baseline|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390156|NCT00650260|P2|Participant Flow|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390157|NCT00650260|P1|Participant Flow|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390158|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390159|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390160|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390161|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390162|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390163|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390164|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390165|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390166|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390217|NCT00650078|E1|Reported Event|NP01|Modified Release (MR) prednisone 5 mg
390218|NCT00649961|B1|Baseline|Single Arm|open label dose finding study
390219|NCT00649961|P1|Participant Flow|Melatonin Open Label Single Arm|Open label single arm study
390220|NCT00649961|O1|Outcome|Single Arm|open label dose finding study
390221|NCT00649961|E1|Reported Event|Single Arm|open label dose finding study
390222|NCT00649792|B1|Baseline|Fampridine-SR|Tablets, 10 mg, BID
390223|NCT00649792|P1|Participant Flow|Fampridine-SR|Tablets, 10 mg, BID
390167|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390168|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390169|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390170|NCT00650260|E2|Reported Event|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390171|NCT00650260|E1|Reported Event|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
390172|NCT00650104|B1|Baseline|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390173|NCT00650104|P1|Participant Flow|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390174|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390224|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
390225|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
390226|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
390227|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
390228|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
390229|NCT00649792|E1|Reported Event|Fampridine-SR|Tablets, 10 mg, BID
390230|NCT00649428|B3|Baseline|Total|Total of all reporting groups
390231|NCT00649428|B2|Baseline|Placebo|Patients treated with placebo solution
390175|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390176|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390177|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390178|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390179|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390180|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390181|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390232|NCT00649428|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
390233|NCT00649428|P2|Participant Flow|Placebo|Patients treated with placebo solution
390234|NCT00649428|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
390235|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
390236|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
390237|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
390182|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390183|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390184|NCT00650104|E1|Reported Event|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
390185|NCT00650091|B3|Baseline|Total|Total of all reporting groups
390186|NCT00650091|B2|Baseline|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390187|NCT00650091|B1|Baseline|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390188|NCT00650091|P3|Participant Flow|Pred/AZA/NAC|"The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.~The azathioprine dose (maximum, 150 mg per day) was based on the patient’s ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day."
390189|NCT00650091|P2|Participant Flow|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390190|NCT00650091|P1|Participant Flow|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390191|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390192|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390193|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390194|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390195|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390196|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390197|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390198|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390199|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390200|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390201|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390202|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390203|NCT00650091|E4|Reported Event|Initial Study: Placebo|Placebo: Participants will receive placebo each day.
390204|NCT00650091|E3|Reported Event|Initial Study: Pred/AZA/NAC|Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
390205|NCT00650091|E2|Reported Event|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
390206|NCT00650091|E1|Reported Event|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
390207|NCT00650078|B3|Baseline|Total|Total of all reporting groups
390208|NCT00650078|B2|Baseline|Placebo|
390209|NCT00650078|B1|Baseline|NP01|Modified Release (MR) prednisone 5 mg
390210|NCT00650078|P2|Participant Flow|Placebo|
390211|NCT00650078|P1|Participant Flow|NP01|Modified Release (MR) prednisone 5 mg
390212|NCT00650078|O2|Outcome|Placebo|
390238|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
390239|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
390240|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
390241|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
390242|NCT00649428|O1|Outcome|Autologous Fibroblast|Patients treated with autologous fibroblasts (azficel-T).
390243|NCT00649428|E2|Reported Event|Placebo|Patients treated with placebo solution.
390244|NCT00649428|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
390245|NCT00649389|B5|Baseline|Total|Total of all reporting groups
390246|NCT00649389|B4|Baseline|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390247|NCT00649389|B3|Baseline|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390248|NCT00649389|B2|Baseline|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390249|NCT00649389|B1|Baseline|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390250|NCT00649389|P4|Participant Flow|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390251|NCT00649389|P3|Participant Flow|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390252|NCT00649389|P2|Participant Flow|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390253|NCT00649389|P1|Participant Flow|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390254|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390255|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390256|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390257|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390258|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390259|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390260|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390261|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390262|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390263|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390264|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390265|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390266|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390267|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390268|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390269|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390270|NCT00649389|E4|Reported Event|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
390271|NCT00649389|E3|Reported Event|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390272|NCT00649389|E2|Reported Event|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
390273|NCT00649389|E1|Reported Event|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
390274|NCT00649220|B1|Baseline|Memantine|Memantine tablets, twice a day (bid).
390275|NCT00649220|P1|Participant Flow|Memantine|Memantine tablets, twice a day (bid).
390276|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390277|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390278|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390279|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390280|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390281|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390282|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390283|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
390284|NCT00649220|E1|Reported Event|Memantine|Memantine tablets, twice a day (bid).
390285|NCT00648908|B1|Baseline|Fampridine-SR|Tablets, 10mg twice daily
390286|NCT00648908|P1|Participant Flow|Fampridine-SR|Tablets, 10mg twice daily
390287|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
390288|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
390289|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
390290|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
390291|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
390294|NCT00648895|B2|Baseline|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
390295|NCT00648895|B1|Baseline|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
390296|NCT00648895|P2|Participant Flow|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
390297|NCT00648895|P1|Participant Flow|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
390298|NCT00648895|O2|Outcome|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
390299|NCT00648895|O1|Outcome|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
390300|NCT00648895|E2|Reported Event|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
390301|NCT00648895|E1|Reported Event|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
390302|NCT00648167|B1|Baseline|KRX-0502|Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
390303|NCT00648167|P1|Participant Flow|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)~Intent-to-Treat (ITT)"
390304|NCT00648167|O2|Outcome|KRX-0502|Patients starting dose of 6.0 grams per day- immediate roll over from previous phosphate binder(s)
390305|NCT00648167|O1|Outcome|KRX-0502 (Ferric Citrate)|Patients starting dose of 4.5 grams per day- immediate roll over from previous phosphate binder(s)
390306|NCT00648167|E1|Reported Event|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)~Intent-to-Treat (ITT)"
390307|NCT00648115|B4|Baseline|Total|Total of all reporting groups
390308|NCT00648115|B3|Baseline|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390309|NCT00648115|B2|Baseline|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390310|NCT00648115|B1|Baseline|Basic Vocational Services|Basic vocational services but no manualized vocational program
390311|NCT00648115|P3|Participant Flow|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390312|NCT00648115|P2|Participant Flow|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390313|NCT00648115|P1|Participant Flow|Basic Vocational Services|Basic vocational services but no manualized vocational program
390314|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390315|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390316|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
390357|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390358|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390317|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390318|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390319|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
390320|NCT00648115|E3|Reported Event|Arm 3|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390321|NCT00648115|E2|Reported Event|Arm 2|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
390322|NCT00648115|E1|Reported Event|Arm 1|Basic vocational services but no manualized vocational program
390323|NCT00648037|B1|Baseline|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
390324|NCT00648037|P1|Participant Flow|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
390325|NCT00648037|O1|Outcome|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
390326|NCT00648037|E1|Reported Event|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
390327|NCT00647998|B3|Baseline|Total|Total of all reporting groups
390328|NCT00647998|B2|Baseline|Standard Care|No darbepoetin
390329|NCT00647998|B1|Baseline|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
390330|NCT00647998|P2|Participant Flow|Standard Care|No darbepoetin
390331|NCT00647998|P1|Participant Flow|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
390332|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
390333|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
390334|NCT00647998|E2|Reported Event|Standard Care|No darbepoetin
390335|NCT00647998|E1|Reported Event|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
390336|NCT00647699|B3|Baseline|Total|Total of all reporting groups
390337|NCT00647699|B2|Baseline|Control Group|riboflavin ophthalmic solution without UVA irradiation
390338|NCT00647699|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
390339|NCT00647699|P2|Participant Flow|Control Group|riboflavin ophthalmic solution without UVA irradiation
390340|NCT00647699|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
390341|NCT00647699|O2|Outcome|Control Group|riboflavin ophthalmic solution without UVA irradiation
390342|NCT00647699|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
390343|NCT00647699|E2|Reported Event|Control Group|riboflavin ophthalmic solution without UVA irradiation
390344|NCT00647699|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
390345|NCT00647556|B3|Baseline|Total|Total of all reporting groups
390346|NCT00647556|B2|Baseline|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390347|NCT00647556|B1|Baseline|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390348|NCT00647556|P2|Participant Flow|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390349|NCT00647556|P1|Participant Flow|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390350|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390351|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390352|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390353|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390354|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390355|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390356|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390359|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390360|NCT00647556|E2|Reported Event|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
390361|NCT00647556|E1|Reported Event|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
390362|NCT00647400|B3|Baseline|Total|Total of all reporting groups
390363|NCT00647400|B2|Baseline|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390364|NCT00647400|B1|Baseline|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390365|NCT00647400|P2|Participant Flow|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390366|NCT00647400|P1|Participant Flow|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390367|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390368|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390369|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390370|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390371|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390372|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390373|NCT00647400|E2|Reported Event|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
390374|NCT00647400|E1|Reported Event|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
390375|NCT00647270|B4|Baseline|Total|Total of all reporting groups
390376|NCT00647270|B3|Baseline|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390377|NCT00647270|B2|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390378|NCT00647270|B1|Baseline|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390379|NCT00647270|P3|Participant Flow|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390380|NCT00647270|P2|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390381|NCT00647270|P1|Participant Flow|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390382|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390383|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390384|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390385|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390386|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390387|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390388|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390389|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390390|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390391|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390392|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390393|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390394|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
390395|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
390396|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390397|NCT00647270|E6|Reported Event|Adalimumab 80 mg Monthly - Period 2|Adalimumab 80 mg monthly for Period 1 and Period 2
390398|NCT00647270|E5|Reported Event|Adalimumab 40 mg Eow-Period 2|Adalimumab 40 mg eow for Period 1 and Period 2
390399|NCT00647270|E4|Reported Event|Placebo/Adalimumab 40 mg Eow-Period 2|Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390400|NCT00647270|E3|Reported Event|Adalimumab 80 mg Monthly-Period 1|Adalimumab 80 mg monthly for Period 1 and Period 2
390401|NCT00647270|E2|Reported Event|Adalimumab 40 mg Eow -Period 1|Adalimumab 40 mg eow for Period 1 and Period 2
390402|NCT00647270|E1|Reported Event|Placebo Every Other Week (Eow)-Period 1|Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
390403|NCT00646958|B4|Baseline|Total|Total of all reporting groups
390404|NCT00646958|B3|Baseline|Linezolid BID|600 mg by mouth (PO) BID
390405|NCT00646958|B2|Baseline|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
390406|NCT00646958|B1|Baseline|Radezolid QD|450 mg by mouth (PO) once daily (QD)
390407|NCT00646958|P3|Participant Flow|Linezolid BID|600 mg by mouth (PO) BID
390408|NCT00646958|P2|Participant Flow|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
390409|NCT00646958|P1|Participant Flow|Radezolid QD|450 mg by mouth (PO) once daily (QD)
390410|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
390411|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
390412|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
390413|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
390414|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
390415|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
390416|NCT00646958|E3|Reported Event|Linezolid BID|600 mg by mouth (PO) BID
390417|NCT00646958|E2|Reported Event|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
390418|NCT00646958|E1|Reported Event|Radezolid QD|450 mg by mouth (PO) once daily (QD)
390419|NCT00646776|B3|Baseline|Total|Total of all reporting groups
390420|NCT00646776|B2|Baseline|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390421|NCT00646776|B1|Baseline|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390422|NCT00646776|P2|Participant Flow|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390423|NCT00646776|P1|Participant Flow|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390424|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390425|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390426|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390427|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390428|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390429|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390448|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390430|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390431|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390432|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390433|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390434|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390435|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390436|NCT00646776|O3|Outcome|RIB 300 mg QD|AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD.
390437|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QAD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390438|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390439|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390440|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390441|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390442|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390443|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390444|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390445|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390446|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390447|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390524|NCT00646399|O1|Outcome|Pagibaximab|
390525|NCT00646399|E2|Reported Event|Placebo|
390449|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390450|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390451|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390452|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390453|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390454|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390455|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390456|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390457|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390458|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390459|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390460|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390461|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390462|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390463|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390464|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390465|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390466|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
390467|NCT00646776|E2|Reported Event|RIB 150mg|
390468|NCT00646776|E1|Reported Event|ATV/RTV 300/100mg+RIB 150mg|
390469|NCT00646763|B3|Baseline|Total|Total of all reporting groups
390470|NCT00646763|B2|Baseline|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390471|NCT00646763|B1|Baseline|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390472|NCT00646763|P2|Participant Flow|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390473|NCT00646763|P1|Participant Flow|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390474|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390475|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390476|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390477|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390478|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390479|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390480|NCT00646763|E2|Reported Event|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
390481|NCT00646763|E1|Reported Event|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
390482|NCT00646646|B5|Baseline|Total|Total of all reporting groups
390483|NCT00646646|B4|Baseline|Propofol|"active drug~propofol : sedative"
390484|NCT00646646|B3|Baseline|Placebo|"placebo control~saline placebo : saline placebo"
390485|NCT00646646|B2|Baseline|Midazolam|"Sedative~Midazolam : sedative"
390486|NCT00646646|B1|Baseline|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
390487|NCT00646646|P4|Participant Flow|Propofol|Sedative Drug 3
390488|NCT00646646|P3|Participant Flow|Placebo|Placebo Control
390489|NCT00646646|P2|Participant Flow|Midazolam|Sedative Drug 2
390490|NCT00646646|P1|Participant Flow|Dexmedetomidine|Sedative Drug 1
390491|NCT00646646|O4|Outcome|Placebo|placebo
390492|NCT00646646|O3|Outcome|Propofol|"active drug~propofol : sedative"
390493|NCT00646646|O2|Outcome|Midazolam|"Sedative~Midazolam : sedative"
390494|NCT00646646|O1|Outcome|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
390495|NCT00646646|E4|Reported Event|Propofol|"active drug~propofol : sedative"
390496|NCT00646646|E3|Reported Event|Placebo|"placebo control~saline placebo : saline placebo"
390497|NCT00646646|E2|Reported Event|Midazolam|"Sedative~Midazolam : sedative"
390498|NCT00646646|E1|Reported Event|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
390499|NCT00646581|B3|Baseline|Total|Total of all reporting groups
390500|NCT00646581|B2|Baseline|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390501|NCT00646581|B1|Baseline|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390502|NCT00646581|P2|Participant Flow|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390503|NCT00646581|P1|Participant Flow|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390504|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390505|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390506|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390507|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390508|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390509|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390510|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390511|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390512|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390513|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390514|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390515|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390516|NCT00646581|E2|Reported Event|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
390517|NCT00646581|E1|Reported Event|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
390518|NCT00646399|B3|Baseline|Total|Total of all reporting groups
390519|NCT00646399|B2|Baseline|Placebo|
390520|NCT00646399|B1|Baseline|Pagibaximab|
390521|NCT00646399|P2|Participant Flow|Placebo|
390522|NCT00646399|P1|Participant Flow|Pagibaximab|
390523|NCT00646399|O2|Outcome|Placebo|
390528|NCT00646282|B2|Baseline|Control|Stable kidney transplant recipients do not receive any drug
390529|NCT00646282|B1|Baseline|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
390530|NCT00646282|P2|Participant Flow|Control|Stable kidney transplant recipients do not receive any drug.
390531|NCT00646282|P1|Participant Flow|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
390532|NCT00646282|O2|Outcome|Control|Stable kidney transplant recipients will not receive any drug
390533|NCT00646282|O1|Outcome|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
390534|NCT00646282|E2|Reported Event|Control|Stable kidney transplant recipients will not receive any drug
390535|NCT00646282|E1|Reported Event|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
390536|NCT00646048|B1|Baseline|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390537|NCT00646048|P1|Participant Flow|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390538|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390539|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390540|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390541|NCT00646048|E1|Reported Event|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
390542|NCT00645970|B3|Baseline|Total|Total of all reporting groups
390543|NCT00645970|B2|Baseline|Registry|Participants recruited from the OEF/OIF/OND registry
390544|NCT00645970|B1|Baseline|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
390545|NCT00645970|P2|Participant Flow|Registry|Participants recruited from the OEF/OIF/OND registry
390546|NCT00645970|P1|Participant Flow|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
390547|NCT00645970|O2|Outcome|Registry|Participants recruited from the OEF/OIF/OND registry
390548|NCT00645970|O1|Outcome|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
390549|NCT00645970|E2|Reported Event|Registry|Participants recruited from the OEF/OIF/OND registry
390550|NCT00645970|E1|Reported Event|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
390551|NCT00645944|B3|Baseline|Total|Total of all reporting groups
390552|NCT00645944|B2|Baseline|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
390553|NCT00645944|B1|Baseline|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
390554|NCT00645944|P2|Participant Flow|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
390555|NCT00645944|P1|Participant Flow|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
390556|NCT00645944|O2|Outcome|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
390557|NCT00645944|O1|Outcome|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
390558|NCT00645944|E2|Reported Event|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
390559|NCT00645944|E1|Reported Event|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
390560|NCT00645853|B3|Baseline|Total|Total of all reporting groups
390561|NCT00645853|B2|Baseline|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390562|NCT00645853|B1|Baseline|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390563|NCT00645853|P2|Participant Flow|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390564|NCT00645853|P1|Participant Flow|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390565|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390566|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390567|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390568|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390569|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390570|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390571|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390572|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390573|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390574|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390575|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390576|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390577|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390578|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
390579|NCT00645853|E2|Reported Event|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
390580|NCT00645853|E1|Reported Event|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
390581|NCT00645827|B3|Baseline|Total|Total of all reporting groups
390582|NCT00645827|B2|Baseline|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390583|NCT00645827|B1|Baseline|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390584|NCT00645827|P2|Participant Flow|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390751|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390585|NCT00645827|P1|Participant Flow|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390586|NCT00645827|O2|Outcome|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390587|NCT00645827|O1|Outcome|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390588|NCT00645827|E2|Reported Event|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390589|NCT00645827|E1|Reported Event|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
390590|NCT00645788|B5|Baseline|Total|Total of all reporting groups
390591|NCT00645788|B4|Baseline|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390592|NCT00645788|B3|Baseline|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390593|NCT00645788|B2|Baseline|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390594|NCT00645788|B1|Baseline|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390595|NCT00645788|P4|Participant Flow|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390596|NCT00645788|P3|Participant Flow|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390597|NCT00645788|P2|Participant Flow|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390598|NCT00645788|P1|Participant Flow|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390599|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390600|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390601|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390602|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390603|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390752|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390604|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390605|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390606|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390607|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390608|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390609|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390610|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390611|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390612|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390613|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390614|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390615|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390616|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390617|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390618|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390619|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390620|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390621|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390622|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390623|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390624|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390625|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390626|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390627|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390628|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390629|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390630|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390631|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390632|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390633|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390634|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390635|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390636|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390637|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390638|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390639|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390640|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390641|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390753|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390642|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390643|NCT00645788|E4|Reported Event|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
390644|NCT00645788|E3|Reported Event|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
390645|NCT00645788|E2|Reported Event|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390646|NCT00645788|E1|Reported Event|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
390647|NCT00645762|B1|Baseline|Balloon Dilation|
390648|NCT00645762|P1|Participant Flow|FinESS Sisnus System Balloon Dilation|Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
390649|NCT00645762|O1|Outcome|FinESS Balloon Arm|Subjects completing 12 month post-procedure follow-up
390650|NCT00645762|O1|Outcome|FinESS Balloon Dilation|
390651|NCT00645762|O1|Outcome|Treatment Group (ALL)|FinESS Balloon Dilation
390652|NCT00645762|E1|Reported Event|Treatment Group (ALL)|
390653|NCT00645671|B3|Baseline|Total|Total of all reporting groups
390654|NCT00645671|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ointment
390655|NCT00645671|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390656|NCT00645671|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ointment
390657|NCT00645671|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390658|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
390659|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390660|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
390661|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390662|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
390663|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390664|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
390665|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390666|NCT00645671|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ointment
390667|NCT00645671|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
390668|NCT00645593|B3|Baseline|Total|Total of all reporting groups
390669|NCT00645593|B2|Baseline|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390670|NCT00645593|B1|Baseline|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390671|NCT00645593|P2|Participant Flow|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390672|NCT00645593|P1|Participant Flow|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390673|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390674|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390675|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390676|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390677|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390678|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390754|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390679|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390680|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390681|NCT00645593|E2|Reported Event|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
390682|NCT00645593|E1|Reported Event|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
390683|NCT00645528|B1|Baseline|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390684|NCT00645528|P1|Participant Flow|Insulin Education Class Participants|"Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit.The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment.~Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them."
390685|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390686|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390687|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390688|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390689|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390690|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390691|NCT00645528|E1|Reported Event|Arm 1|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
390692|NCT00645411|B5|Baseline|Total|Total of all reporting groups
390693|NCT00645411|B4|Baseline|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390694|NCT00645411|B3|Baseline|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390695|NCT00645411|B2|Baseline|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
390696|NCT00645411|B1|Baseline|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390697|NCT00645411|P4|Participant Flow|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390698|NCT00645411|P3|Participant Flow|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390699|NCT00645411|P2|Participant Flow|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
390700|NCT00645411|P1|Participant Flow|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390701|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
390702|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390703|NCT00645411|O2|Outcome|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
390704|NCT00645411|O1|Outcome|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390705|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390706|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390707|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390708|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
391464|NCT00642707|E1|Reported Event|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
390709|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390710|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390711|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390712|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390713|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
390714|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390715|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
390716|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390717|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
390718|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390719|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
390720|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
390721|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390722|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390723|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
390724|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390725|NCT00645411|E6|Reported Event|Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390726|NCT00645411|E5|Reported Event|Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390727|NCT00645411|E4|Reported Event|Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
390728|NCT00645411|E3|Reported Event|Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
390729|NCT00645411|E2|Reported Event|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
390730|NCT00645411|E1|Reported Event|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
390731|NCT00645359|B1|Baseline|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
390732|NCT00645359|P1|Participant Flow|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
390733|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
390734|NCT00645359|E1|Reported Event|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
390735|NCT00645333|B1|Baseline|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
390736|NCT00645333|P1|Participant Flow|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
390737|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
390738|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
390739|NCT00645333|E1|Reported Event|MK-0752|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
390740|NCT00645164|B1|Baseline|Xenaderm|Subject serves as own control
390741|NCT00645164|P1|Participant Flow|Xenaderm|Subject serves as own control
390742|NCT00645164|O1|Outcome|Xenaderm|Subject serves as own control
390743|NCT00645164|E1|Reported Event|Xenaderm|Subject serves as own control
390744|NCT00645099|B3|Baseline|Total|Total of all reporting groups
390745|NCT00645099|B2|Baseline|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390746|NCT00645099|B1|Baseline|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390747|NCT00645099|P2|Participant Flow|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390748|NCT00645099|P1|Participant Flow|Paliperidone Extended Release (ER)|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390749|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390750|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390755|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390756|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390757|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390758|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390759|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390760|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390761|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390762|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390763|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390764|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390765|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390766|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390767|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390768|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390769|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390770|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390771|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390772|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390773|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390774|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390775|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390776|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390777|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390778|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390779|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390780|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390781|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390782|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390783|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390784|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390785|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390786|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390787|NCT00645099|E2|Reported Event|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
390788|NCT00645099|E1|Reported Event|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
390789|NCT00644995|B3|Baseline|Total|Total of all reporting groups
390790|NCT00644995|B2|Baseline|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity (PA)
390791|NCT00644995|B1|Baseline|Usual Care|Advice to quit smoking and referral to standard care
390792|NCT00644995|P2|Participant Flow|Step Up|proactive phone counseling addressing smoking, depression, and PA
390793|NCT00644995|P1|Participant Flow|Usual Care|Advice to quit and referral to standard care
390794|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
390795|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390796|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
390797|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390798|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
390799|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390800|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
390801|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390802|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
390803|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390804|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and PA
390805|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390806|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and physical activity
390807|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
390808|NCT00644995|E2|Reported Event|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity
390809|NCT00644995|E1|Reported Event|Usual Care|Advice to quit and referral to standard care
390810|NCT00644969|B3|Baseline|Total|Total of all reporting groups
390811|NCT00644969|B2|Baseline|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390812|NCT00644969|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
391118|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
390813|NCT00644969|P2|Participant Flow|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390814|NCT00644969|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390815|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390816|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390817|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390818|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390819|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390820|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390821|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390822|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390823|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390824|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390825|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390826|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390827|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390828|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390829|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390830|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390831|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390832|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390833|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390834|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390835|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390836|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390837|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390838|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390839|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390840|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390841|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390842|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390843|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390844|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390845|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390846|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390847|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390848|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390849|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
391119|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
390850|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390851|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390852|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390853|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390854|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390855|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390856|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390857|NCT00644969|E2|Reported Event|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
390858|NCT00644969|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
390859|NCT00644917|B1|Baseline|Xenaderm vs. Vehicle - Subjects Acted as Own Comparator|Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
390860|NCT00644917|P1|Participant Flow|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
390861|NCT00644917|O5|Outcome|Xenaderm Vehicle - Non-irradiated|20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
390862|NCT00644917|O4|Outcome|Xenaderm Ointment - Non-irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
390863|NCT00644917|O3|Outcome|Control - Irradiated|test site was covered with an empty Finn Chamber as a control site - then irradiated
390864|NCT00644917|O2|Outcome|Xenaderm Vehicle - Irradiated|20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated
390865|NCT00644917|O1|Outcome|Xenaderm Ointment - Irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated
390866|NCT00644917|E1|Reported Event|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
390867|NCT00644787|B1|Baseline|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390868|NCT00644787|P3|Participant Flow|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390869|NCT00644787|P2|Participant Flow|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390870|NCT00644787|P1|Participant Flow|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390871|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390872|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390873|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390874|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390875|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390876|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390877|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390878|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390879|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390880|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390881|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390882|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390883|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390884|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390885|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390886|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390887|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390934|NCT00644280|E1|Reported Event|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
390935|NCT00644059|B4|Baseline|Total|Total of all reporting groups
390888|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390889|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390890|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390891|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390892|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390893|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390894|NCT00644787|E3|Reported Event|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390895|NCT00644787|E2|Reported Event|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
390896|NCT00644787|E1|Reported Event|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
390897|NCT00644657|B1|Baseline|Clopidogrel|All 27 subjects received a 300 mg loading dose of clopidogrel
390898|NCT00644657|P1|Participant Flow|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
390899|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
390900|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
390901|NCT00644657|E1|Reported Event|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
390902|NCT00644592|B3|Baseline|Total|Total of all reporting groups
390903|NCT00644592|B2|Baseline|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
390904|NCT00644592|B1|Baseline|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
390905|NCT00644592|P2|Participant Flow|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
390906|NCT00644592|P1|Participant Flow|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
390907|NCT00644592|O2|Outcome|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
390908|NCT00644592|O1|Outcome|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
390909|NCT00644592|E2|Reported Event|2 Placebo|4 weeks of placebo.
390910|NCT00644592|E1|Reported Event|1-Fenofibrate|4 weeks of drug at 160 mg orally per day
390911|NCT00644332|B1|Baseline|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390912|NCT00644332|P1|Participant Flow|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390913|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390914|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390915|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390916|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390917|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390918|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390919|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390920|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390921|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390922|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390923|NCT00644332|E1|Reported Event|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
390924|NCT00644280|B3|Baseline|Total|Total of all reporting groups
390925|NCT00644280|B2|Baseline|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
390926|NCT00644280|B1|Baseline|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
390927|NCT00644280|P2|Participant Flow|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
390928|NCT00644280|P1|Participant Flow|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
390929|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
390930|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
390931|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
390932|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
390933|NCT00644280|E2|Reported Event|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
391116|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
390936|NCT00644059|B3|Baseline|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390937|NCT00644059|B2|Baseline|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390938|NCT00644059|B1|Baseline|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390939|NCT00644059|P3|Participant Flow|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
390940|NCT00644059|P2|Participant Flow|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390941|NCT00644059|P1|Participant Flow|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390942|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of
390943|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390944|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390945|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390946|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390947|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390948|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
390949|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390950|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390951|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390952|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390953|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390954|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390955|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390956|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390957|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390958|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390959|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390960|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390961|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390962|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390963|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390964|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390965|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
391465|NCT00642694|B3|Baseline|Total|Total of all reporting groups
390966|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390967|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390968|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
390969|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390970|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390971|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390972|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390973|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390974|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390975|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390976|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390977|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390978|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390979|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390980|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390981|NCT00644059|O6|Outcome|Flu Control (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390982|NCT00644059|O5|Outcome|Non-flu Control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390983|NCT00644059|O4|Outcome|TIV-adj (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390984|NCT00644059|O3|Outcome|Flu-control (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390985|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390986|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
390987|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390988|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390989|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390990|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390991|NCT00644059|O5|Outcome|Non-flu Control (36 to < 72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390992|NCT00644059|O4|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390993|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390994|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390995|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390996|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
390997|NCT00644059|O5|Outcome|Non-flu Control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
390998|NCT00644059|O4|Outcome|TIV-adj (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
390999|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391000|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391001|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391002|NCT00644059|O6|Outcome|Non-Flu-control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391003|NCT00644059|O5|Outcome|Flu-control (6 to <72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391004|NCT00644059|O4|Outcome|TIV-adj (6 to <72 Months )|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391005|NCT00644059|O3|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391006|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391007|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391008|NCT00644059|O6|Outcome|Non-Flu-control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391009|NCT00644059|O5|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391010|NCT00644059|O4|Outcome|Flu-control (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391011|NCT00644059|O3|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391012|NCT00644059|O2|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391013|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391014|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391015|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391016|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391017|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
391018|NCT00644059|E6|Reported Event|Non-Flu-control (TBE Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391019|NCT00644059|E5|Reported Event|Non-Flu-control (TBE/Men C Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
391020|NCT00644059|E4|Reported Event|Flu-control_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391021|NCT00644059|E3|Reported Event|Flu-control_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
391022|NCT00644059|E2|Reported Event|TIV-adj_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391023|NCT00644059|E1|Reported Event|TIV-adj_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
391024|NCT00643201|B3|Baseline|Total|Total of all reporting groups
391025|NCT00643201|B2|Baseline|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391026|NCT00643201|B1|Baseline|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham International normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391466|NCT00642694|B2|Baseline|Escitalopram + Placebo|Placebo augmentation
391027|NCT00643201|P2|Participant Flow|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~Warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391028|NCT00643201|P1|Participant Flow|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham international normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391029|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391030|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391031|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391032|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391033|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391034|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391035|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391036|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391037|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391038|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391039|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391040|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391041|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391042|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391043|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391044|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391045|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391046|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391047|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391048|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391049|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391050|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391051|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391052|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391053|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391054|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391055|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391056|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391057|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391058|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391059|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391060|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391061|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391062|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391063|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391064|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391065|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391066|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391067|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391068|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391117|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
391069|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391070|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391071|NCT00643201|E2|Reported Event|Enoxaparin/Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
391072|NCT00643201|E1|Reported Event|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
391073|NCT00643097|B4|Baseline|Total|Total of all reporting groups
391074|NCT00643097|B3|Baseline|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391075|NCT00643097|B2|Baseline|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391076|NCT00643097|B1|Baseline|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391077|NCT00643097|P3|Participant Flow|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391078|NCT00643097|P2|Participant Flow|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391079|NCT00643097|P1|Participant Flow|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391080|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391081|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391082|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391083|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391084|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391085|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391467|NCT00642694|B1|Baseline|Escitalopram + Ramelteon|active augmentation
391086|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391087|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391088|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391089|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391090|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391091|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391092|NCT00643097|E3|Reported Event|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
391093|NCT00643097|E2|Reported Event|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
391094|NCT00643097|E1|Reported Event|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
391095|NCT00643916|B7|Baseline|Total|Total of all reporting groups
391096|NCT00643916|B6|Baseline|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
391097|NCT00643916|B5|Baseline|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
391098|NCT00643916|B4|Baseline|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
391099|NCT00643916|B3|Baseline|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
391100|NCT00643916|B2|Baseline|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
391101|NCT00643916|B1|Baseline|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
391102|NCT00643916|P6|Participant Flow|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
391103|NCT00643916|P5|Participant Flow|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
391104|NCT00643916|P4|Participant Flow|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
391105|NCT00643916|P3|Participant Flow|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
391106|NCT00643916|P2|Participant Flow|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
391107|NCT00643916|P1|Participant Flow|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
391108|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
391109|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
391110|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
391111|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
391112|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
391113|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
391114|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
391115|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
391120|NCT00643916|E6|Reported Event|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
391121|NCT00643916|E5|Reported Event|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
391122|NCT00643916|E4|Reported Event|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
391123|NCT00643916|E3|Reported Event|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
391124|NCT00643916|E2|Reported Event|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
391125|NCT00643916|E1|Reported Event|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
391126|NCT00643760|B6|Baseline|Total|Total of all reporting groups
391127|NCT00643760|B5|Baseline|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391128|NCT00643760|B4|Baseline|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391129|NCT00643760|B3|Baseline|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391130|NCT00643760|B2|Baseline|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391131|NCT00643760|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391132|NCT00643760|P5|Participant Flow|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391133|NCT00643760|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391134|NCT00643760|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391135|NCT00643760|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391136|NCT00643760|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391137|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391138|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391139|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391140|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391141|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391142|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391143|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391144|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391145|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391146|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391147|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391148|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391149|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391150|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391207|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391151|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391152|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391153|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391154|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391155|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391156|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391157|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391158|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391159|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391160|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391161|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391162|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391163|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391164|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391165|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391166|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391167|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391168|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391169|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391170|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391171|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391172|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391173|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391174|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391175|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391176|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391177|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391178|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391311|NCT00643448|P3|Participant Flow|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391179|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391180|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391181|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391182|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391183|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391184|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391185|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391186|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391187|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391188|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391189|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391190|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391191|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391192|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391193|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391194|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391195|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391196|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391197|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391198|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391199|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391200|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391201|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391202|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391203|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391204|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391205|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391206|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391468|NCT00642694|P2|Participant Flow|Escitalopram + Placebo|Placebo augmentation
391208|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391209|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391210|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391211|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391212|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391213|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391214|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391215|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391216|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391217|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391218|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391219|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391220|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391221|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391222|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391223|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391224|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391225|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391226|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391227|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391228|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391229|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391230|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391231|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391232|NCT00643760|E5|Reported Event|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
391233|NCT00643760|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391234|NCT00643760|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391235|NCT00643760|E2|Reported Event|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
391469|NCT00642694|P1|Participant Flow|Escitalopram + Ramelteon|active augmentation
391236|NCT00643760|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
391237|NCT00643682|B3|Baseline|Total|Total of all reporting groups
391238|NCT00643682|B2|Baseline|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391239|NCT00643682|B1|Baseline|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391240|NCT00643682|P2|Participant Flow|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391241|NCT00643682|P1|Participant Flow|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391242|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391243|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391244|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391245|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391246|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391247|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391248|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391249|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391250|NCT00643682|E2|Reported Event|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
391251|NCT00643682|E1|Reported Event|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
391252|NCT00643604|B1|Baseline|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391253|NCT00643604|P1|Participant Flow|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391254|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391255|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391256|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391257|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391258|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391259|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391260|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391261|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391262|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391263|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391264|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391265|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391266|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391267|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391268|NCT00643604|E1|Reported Event|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
391269|NCT00643578|B1|Baseline|All Participants|A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
391270|NCT00643578|P2|Participant Flow|Formoterol 24 First|a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
391271|NCT00643578|P1|Participant Flow|Formoterol 12 First|a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
391272|NCT00643578|O2|Outcome|24 Mcg of Formoterol|high dose
391273|NCT00643578|O1|Outcome|12 Mcg of Formoterol|low dose
391274|NCT00643578|O2|Outcome|24 Mcg Formoterol|high dose
391275|NCT00643578|O1|Outcome|12 Mcg Formoterol|low dose
391276|NCT00643578|E2|Reported Event|Formoterol 24|A single dose of 24 mcg of formoterol was administered.
391277|NCT00643578|E1|Reported Event|Formoterol 12|A single dose of 12 mcg of formoterol was administered.
391278|NCT00643565|B3|Baseline|Total|Total of all reporting groups
391312|NCT00643448|P2|Participant Flow|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391279|NCT00643565|B2|Baseline|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391280|NCT00643565|B1|Baseline|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391281|NCT00643565|P2|Participant Flow|Bevacizumab + Chemotherapy|Participants received continuous intravenous (IV) infusion of bevacizumab (7.5 milligrams per kilogram [mg/kg] every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391282|NCT00643565|P1|Participant Flow|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy i.e. with ifosfamide [I], vincristine [V], actinomycin D [A] and doxorubicin [Do] followed by 5 cycles of IVA-containing chemotherapy [i.e. without doxorubicin]) administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391283|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391284|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391285|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391286|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391296|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391470|NCT00642694|O2|Outcome|Escitalopram + Placebo|control group
391287|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391288|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391289|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391290|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391291|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391292|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391293|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391294|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391295|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391308|NCT00643448|B3|Baseline|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391309|NCT00643448|B2|Baseline|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391310|NCT00643448|B1|Baseline|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391297|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391298|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391299|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391300|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391301|NCT00643565|E2|Reported Event|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
391302|NCT00643565|E1|Reported Event|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
391303|NCT00643487|B1|Baseline|All Participants|No new arms or groups were associated with this observational study
391304|NCT00643487|P1|Participant Flow|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
391305|NCT00643487|O1|Outcome|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
391306|NCT00643487|E1|Reported Event|All Participants|observation of the behavior of the infrapatellar plica: Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
391307|NCT00643448|B4|Baseline|Total|Total of all reporting groups
391461|NCT00642707|E4|Reported Event|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
391313|NCT00643448|P1|Participant Flow|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391314|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391315|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391316|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391317|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391318|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391319|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391320|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391321|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391322|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391323|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391324|NCT00643448|E3|Reported Event|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
391325|NCT00643448|E2|Reported Event|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391326|NCT00643448|E1|Reported Event|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
391327|NCT00643006|B3|Baseline|Total|Total of all reporting groups
391328|NCT00643006|B2|Baseline|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
391329|NCT00643006|B1|Baseline|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
391330|NCT00643006|P2|Participant Flow|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
391331|NCT00643006|P1|Participant Flow|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
391332|NCT00643006|O2|Outcome|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
391333|NCT00643006|O1|Outcome|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
391334|NCT00643006|O2|Outcome|Arm B. Active Comparator|The active comparison group participated in low-intensive walks.
391335|NCT00643006|O1|Outcome|Arm A. Exercise|The intervention group participated in Nordic walking
391336|NCT00643006|E2|Reported Event|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
391337|NCT00643006|E1|Reported Event|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
391338|NCT00642993|B3|Baseline|Total|Total of all reporting groups
391339|NCT00642993|B2|Baseline|Placebo|Placebo capsules, administered orally, once daily
391340|NCT00642993|B1|Baseline|SCH 497079|SCH 497079, administered orally, once daily
391341|NCT00642993|P2|Participant Flow|Placebo|Placebo capsules, administered orally, once daily
391342|NCT00642993|P1|Participant Flow|SCH 497079|SCH 497079, administered orally, once daily
391343|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
391344|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
391345|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
391346|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
391347|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
391348|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
391349|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
391350|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
391351|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
391352|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
391353|NCT00642993|E2|Reported Event|Placebo|Placebo capsules, administered orally, once daily
391354|NCT00642993|E1|Reported Event|SCH 497079|SCH 497079, administered orally, once daily
391355|NCT00642902|B5|Baseline|Total|Total of all reporting groups
391356|NCT00642902|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391357|NCT00642902|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391358|NCT00642902|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391359|NCT00642902|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391462|NCT00642707|E3|Reported Event|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
391360|NCT00642902|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391361|NCT00642902|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391362|NCT00642902|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391363|NCT00642902|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391364|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391365|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391366|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391367|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391368|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391369|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391370|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391371|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391372|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391373|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391374|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391375|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391376|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391377|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391378|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391379|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391380|NCT00642902|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
391381|NCT00642902|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
391382|NCT00642902|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
391383|NCT00642902|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
391384|NCT00642850|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391385|NCT00642850|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
391386|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391387|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391388|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391389|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391390|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391463|NCT00642707|E2|Reported Event|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
391391|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391392|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391393|NCT00642850|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
391394|NCT00642811|B7|Baseline|Total|Total of all reporting groups
391395|NCT00642811|B6|Baseline|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391396|NCT00642811|B5|Baseline|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391397|NCT00642811|B4|Baseline|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391398|NCT00642811|B3|Baseline|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391399|NCT00642811|B2|Baseline|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391400|NCT00642811|B1|Baseline|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391401|NCT00642811|P6|Participant Flow|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
391402|NCT00642811|P5|Participant Flow|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
391403|NCT00642811|P4|Participant Flow|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
391404|NCT00642811|P3|Participant Flow|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks
391405|NCT00642811|P2|Participant Flow|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
391406|NCT00642811|P1|Participant Flow|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
391407|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391408|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391409|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391410|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391411|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391412|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391413|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391414|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391415|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391416|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391417|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391418|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
391419|NCT00642811|E8|Reported Event|Clop. Responders/Switching Period: Clopidogrel-Ticagrelor|included responders exposed to clopidogrel switching to ticagrelor on Day 15.
391420|NCT00642811|E7|Reported Event|Clop. Responders/Switching Period: Ticagrelor-Clopidogrel|included responders exposed to ticagrelor switching to clopidogrel on Day 15.
391421|NCT00642811|E6|Reported Event|Clop. Responders/Non-Switching Period: Clopidogrel|included responders exposed to clopidogrel on Day 1-14, Day 16-28.
391422|NCT00642811|E5|Reported Event|Clop. Responders/Non-Switching Period: Ticagrelor|included responders exposed to ticagrelor on Day 1-14, Day 16-28.
391423|NCT00642811|E4|Reported Event|Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor|included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.
391424|NCT00642811|E3|Reported Event|Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel|included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.
391425|NCT00642811|E2|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel|included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.
391426|NCT00642811|E1|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor|included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.
391427|NCT00642772|B1|Baseline|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
391428|NCT00642772|P1|Participant Flow|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
391429|NCT00642772|O1|Outcome|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
391430|NCT00642772|E1|Reported Event|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
391431|NCT00642759|B1|Baseline|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
391432|NCT00642759|P1|Participant Flow|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
391433|NCT00642759|O1|Outcome|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
391434|NCT00642759|E1|Reported Event|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
391435|NCT00642746|B3|Baseline|Total|Total of all reporting groups
391436|NCT00642746|B2|Baseline|FOLFOX With Erlotinib|
391437|NCT00642746|B1|Baseline|FOLFIRI With Erlotinib|
391438|NCT00642746|P2|Participant Flow|FOLFOX With Erlotinib|
391439|NCT00642746|P1|Participant Flow|FOLFIRI With Erlotinib|
391440|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
391441|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
391442|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
391443|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
391444|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
391445|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
391446|NCT00642746|E2|Reported Event|FOLFOX With Erlotinib|
391447|NCT00642746|E1|Reported Event|FOLFIRI With Erlotinib|
391448|NCT00642707|B5|Baseline|Total|Total of all reporting groups
391449|NCT00642707|B4|Baseline|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
391450|NCT00642707|B3|Baseline|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
391451|NCT00642707|B2|Baseline|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
391452|NCT00642707|B1|Baseline|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
391453|NCT00642707|P4|Participant Flow|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
391454|NCT00642707|P3|Participant Flow|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
391455|NCT00642707|P2|Participant Flow|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
391456|NCT00642707|P1|Participant Flow|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
391457|NCT00642707|O4|Outcome|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
391458|NCT00642707|O3|Outcome|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
391459|NCT00642707|O2|Outcome|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
391460|NCT00642707|O1|Outcome|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
391474|NCT00642694|E2|Reported Event|Escitalopram + Placebo|Placebo augmentation
391475|NCT00642694|E1|Reported Event|Escitalopram + Ramelteon|active augmentation
391476|NCT00642668|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391477|NCT00642668|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391478|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391479|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391480|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391481|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391482|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391483|NCT00642668|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
391484|NCT00642642|B1|Baseline|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
391485|NCT00642642|P1|Participant Flow|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
391486|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks randomized to receive placebo treatment
391487|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
391488|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
391489|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
391490|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
391491|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks treated with autologous fibroblasts
391492|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
391493|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
391494|NCT00642642|E3|Reported Event|Non-treatment Area Adverse Events|Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
391495|NCT00642642|E2|Reported Event|Placebo Cheeks|Cheeks randomized to receive placebo treatment
391496|NCT00642642|E1|Reported Event|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
391497|NCT00642616|B5|Baseline|Total|Total of all reporting groups
391498|NCT00642616|B4|Baseline|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD.
391499|NCT00642616|B3|Baseline|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
391500|NCT00642616|B2|Baseline|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
391501|NCT00642616|B1|Baseline|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
391502|NCT00642616|P4|Participant Flow|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
391503|NCT00642616|P3|Participant Flow|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
391504|NCT00642616|P2|Participant Flow|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
391505|NCT00642616|P1|Participant Flow|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391506|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
391507|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
391508|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
391509|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391510|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
391511|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
391512|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
391513|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391514|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
391515|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
391516|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
391517|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391518|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
391519|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
391520|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
391521|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391522|NCT00642616|E4|Reported Event|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
391523|NCT00642616|E3|Reported Event|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
391524|NCT00642616|E2|Reported Event|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
391525|NCT00642616|E1|Reported Event|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
391526|NCT00642603|B3|Baseline|Total|Total of all reporting groups
391527|NCT00642603|B2|Baseline|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391528|NCT00642603|B1|Baseline|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391529|NCT00642603|P2|Participant Flow|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391530|NCT00642603|P1|Participant Flow|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391531|NCT00642603|O2|Outcome|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391532|NCT00642603|O1|Outcome|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391533|NCT00642603|E2|Reported Event|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391534|NCT00642603|E1|Reported Event|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
391535|NCT00642473|B3|Baseline|Total|Total of all reporting groups
391536|NCT00642473|B2|Baseline|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391537|NCT00642473|B1|Baseline|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391538|NCT00642473|P2|Participant Flow|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391539|NCT00642473|P1|Participant Flow|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391540|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
391541|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
391542|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
391543|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash.
391544|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
391545|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
391546|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
391547|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash .
391548|NCT00642473|E2|Reported Event|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391549|NCT00642473|E1|Reported Event|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
391550|NCT00642460|B3|Baseline|Total|Total of all reporting groups
391551|NCT00642460|B2|Baseline|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391552|NCT00642460|B1|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
391553|NCT00642460|P6|Participant Flow|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391554|NCT00642460|P5|Participant Flow|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391555|NCT00642460|P4|Participant Flow|Tocilizumab Switchers|"Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
391556|NCT00642460|P3|Participant Flow|Placebo|Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
391557|NCT00642460|P2|Participant Flow|Tocilizumab_12 mg/kg|"Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391558|NCT00642460|P1|Participant Flow|Tocilizumab_8 mg/kg|"Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
392656|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
391559|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391560|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391561|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391562|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391563|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391564|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391565|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391566|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391567|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391568|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391569|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391570|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391571|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391572|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391573|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391574|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391575|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391576|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391577|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391578|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391579|NCT00642460|O1|Outcome|All Participants Treated With Tocilizumab|"Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391580|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
392002|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
391581|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391582|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391583|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391584|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391585|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391586|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391587|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391588|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391589|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391590|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391591|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391592|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391593|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391594|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391595|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391596|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391597|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391598|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391599|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391600|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391601|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391602|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391603|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391604|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391605|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
392698|NCT00639379|O1|Outcome|Senofilcon A Toric|
392699|NCT00639379|O2|Outcome|Alphafilcon A Toric|
391606|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391607|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391608|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391609|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391610|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391611|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391612|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391613|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391614|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391615|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391616|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391617|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391618|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391619|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
391620|NCT00642460|E1|Reported Event|All Tocilizumab (Part I, Part II and Part III)|Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
391621|NCT00642369|B3|Baseline|Total|Total of all reporting groups
391622|NCT00642369|B2|Baseline|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
391623|NCT00642369|B1|Baseline|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
391624|NCT00642369|P2|Participant Flow|Haloperidol|slow wave sleep% in haloperidol treatment group
391625|NCT00642369|P1|Participant Flow|Quetiapine Fumarate|slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
391626|NCT00642369|O2|Outcome|Haloperidol|percentage of rapid eye movement sleep in haloperidol group
391627|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of rapid eye movement sleep in quetiapine fumarate group
391628|NCT00642369|O2|Outcome|Haloperidol|percentage of slow wave sleep in haloperidol group
391629|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of slow wave sleep in quetiapine fumarate group
391630|NCT00642369|E2|Reported Event|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
391631|NCT00642369|E1|Reported Event|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
391632|NCT00642356|B3|Baseline|Total|Total of all reporting groups
391633|NCT00642356|B2|Baseline|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
391634|NCT00642356|B1|Baseline|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
391635|NCT00642356|P2|Participant Flow|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
391636|NCT00642356|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
391637|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
392003|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
391638|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
391639|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
391640|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
391641|NCT00642356|E2|Reported Event|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
391642|NCT00642356|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
391643|NCT00642304|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391644|NCT00642304|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
391645|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391646|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391647|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391648|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391649|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391650|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391651|NCT00642304|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
391652|NCT00642278|B8|Baseline|Total|Total of all reporting groups
391653|NCT00642278|B7|Baseline|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391654|NCT00642278|B6|Baseline|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391655|NCT00642278|B5|Baseline|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391656|NCT00642278|B4|Baseline|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391657|NCT00642278|B3|Baseline|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391658|NCT00642278|B2|Baseline|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391659|NCT00642278|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391660|NCT00642278|P7|Participant Flow|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391661|NCT00642278|P6|Participant Flow|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391662|NCT00642278|P5|Participant Flow|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
392700|NCT00639379|O1|Outcome|Senofilcon A Toric|
391663|NCT00642278|P4|Participant Flow|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391664|NCT00642278|P3|Participant Flow|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391665|NCT00642278|P2|Participant Flow|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391666|NCT00642278|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391667|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391668|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391669|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391670|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391671|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391672|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391673|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391674|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391675|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391676|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391677|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391678|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391679|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391680|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391681|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391682|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391683|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391684|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391685|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391686|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391687|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391688|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391689|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391690|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391691|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391692|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391693|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391694|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391695|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391696|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391697|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391698|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391699|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
392701|NCT00639379|O2|Outcome|Alphafilcon A Toric|
391700|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391701|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391702|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391703|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391704|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391705|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391706|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391707|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391708|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391709|NCT00642278|E7|Reported Event|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391710|NCT00642278|E6|Reported Event|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
391711|NCT00642278|E5|Reported Event|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391712|NCT00642278|E4|Reported Event|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391713|NCT00642278|E3|Reported Event|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391714|NCT00642278|E2|Reported Event|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
391715|NCT00642278|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 12 weeks.
391716|NCT00642174|B3|Baseline|Total|Total of all reporting groups
391717|NCT00642174|B2|Baseline|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391718|NCT00642174|B1|Baseline|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391719|NCT00642174|P2|Participant Flow|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391720|NCT00642174|P1|Participant Flow|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391721|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391722|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391723|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391724|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391725|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391726|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391727|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391728|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391729|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391730|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391731|NCT00642174|E2|Reported Event|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
391732|NCT00642174|E1|Reported Event|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
391733|NCT00641862|B3|Baseline|Total|Total of all reporting groups
391734|NCT00641862|B2|Baseline|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
391735|NCT00641862|B1|Baseline|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
391736|NCT00641862|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
391737|NCT00641862|P1|Participant Flow|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
391738|NCT00641862|O2|Outcome|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
391739|NCT00641862|O1|Outcome|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
391740|NCT00641862|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
391741|NCT00641862|E1|Reported Event|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
391742|NCT00640835|B3|Baseline|Total|Total of all reporting groups
391743|NCT00640835|B2|Baseline|Buprenorphine/Naloxone Film Strip Administered Buccally|
391744|NCT00640835|B1|Baseline|Buprenorphine/Naloxone Film Strip Administered Sublingually|
391745|NCT00640835|P2|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Buccally|
391746|NCT00640835|P1|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Sublingually|
391747|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
391748|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
391749|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
391750|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
391751|NCT00640835|E2|Reported Event|Buprenorphine/Naloxone Film Strip Administered Buccally|
391752|NCT00640835|E1|Reported Event|Buprenorphine/Naloxone Film Strip Administered Sublingually|
391753|NCT00641745|B3|Baseline|Total|Total of all reporting groups
391754|NCT00641745|B2|Baseline|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
391755|NCT00641745|B1|Baseline|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
391756|NCT00641745|P2|Participant Flow|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
391757|NCT00641745|P1|Participant Flow|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
391758|NCT00641745|O2|Outcome|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
391759|NCT00641745|O1|Outcome|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
391760|NCT00641745|E2|Reported Event|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
391761|NCT00641745|E1|Reported Event|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
391762|NCT00641719|B3|Baseline|Total|Total of all reporting groups
391763|NCT00641719|B2|Baseline|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391764|NCT00641719|B1|Baseline|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391765|NCT00641719|P2|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391766|NCT00641719|P1|Participant Flow|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391767|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391768|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391769|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391770|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391771|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391772|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391773|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391774|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391775|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391776|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391777|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391778|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391779|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391780|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391781|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391782|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391783|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391784|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391785|NCT00641719|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
391786|NCT00641719|E1|Reported Event|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
391787|NCT00641706|B3|Baseline|Total|Total of all reporting groups
391788|NCT00641706|B2|Baseline|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
391789|NCT00641706|B1|Baseline|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391790|NCT00641706|P2|Participant Flow|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
391791|NCT00641706|P1|Participant Flow|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391792|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
391793|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391794|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
391795|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391796|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
391797|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391798|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
391799|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
391800|NCT00641706|E2|Reported Event|Arm B (Undergoing Surgery)|vorinostat : Given orally
391801|NCT00641706|E1|Reported Event|Arm A (Not Undergoing Surgery)|vorinostat : Given orally
391802|NCT00641667|B1|Baseline|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391803|NCT00641667|P1|Participant Flow|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391804|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391805|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391806|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391807|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391808|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391809|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391810|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391811|NCT00641667|E1|Reported Event|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
391812|NCT00641641|B1|Baseline|Drug Intervention|Tenofovir+emtricitabine+raltegravir
391813|NCT00641641|P1|Participant Flow|Drug Intervention|Tenofovir+emtricitabine+raltegravir
391814|NCT00641641|O1|Outcome|Drug Intervention|Tenofovir+emtricitabine+raltegravir
391815|NCT00641641|E1|Reported Event|Drug Intervention|Tenofovir+emtricitabine+raltegravir
391816|NCT00641563|B1|Baseline|All Study Participants|Both arms combined
391817|NCT00641563|P2|Participant Flow|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
391818|NCT00641563|P1|Participant Flow|Dex/Remi Followed by Mida/Remi|Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
391819|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
391820|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
391821|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
391822|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
391823|NCT00641563|E2|Reported Event|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
391824|NCT00641563|E1|Reported Event|Dex/Remi|Sedation with dexmedetomidine and remifentanil
391825|NCT00641537|B6|Baseline|Total|Total of all reporting groups
391826|NCT00641537|B5|Baseline|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391827|NCT00641537|B4|Baseline|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391828|NCT00641537|B3|Baseline|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391829|NCT00641537|B2|Baseline|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391830|NCT00641537|B1|Baseline|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391831|NCT00641537|P8|Participant Flow|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391832|NCT00641537|P7|Participant Flow|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391833|NCT00641537|P6|Participant Flow|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391834|NCT00641537|P5|Participant Flow|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391881|NCT00641537|E9|Reported Event|Cladribine Low/Placebo (LLPP) (24-week Follow-up Period)|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391943|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391835|NCT00641537|P4|Participant Flow|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391836|NCT00641537|P3|Participant Flow|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391837|NCT00641537|P2|Participant Flow|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391838|NCT00641537|P1|Participant Flow|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391839|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391840|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391841|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391842|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391843|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391844|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391845|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391846|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391847|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391848|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391904|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
392702|NCT00639379|O1|Outcome|Senofilcon A Toric|
391849|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391850|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391851|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391852|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391853|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391854|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391855|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391856|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391857|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391858|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391859|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391860|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391861|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391862|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391942|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
392000|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
391863|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391864|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391865|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391866|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391867|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391868|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391869|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391870|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391871|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391872|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391873|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391874|NCT00641537|E16|Reported Event|Cladribine 5.25 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391875|NCT00641537|E15|Reported Event|Cladribine 3.5 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391876|NCT00641537|E14|Reported Event|Placebo/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24-Week supplemental follow-up period.
391877|NCT00641537|E13|Reported Event|Placebo/Cladribine Low Dose (PPLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391878|NCT00641537|E12|Reported Event|Cladribine High/Low Dose (HLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391879|NCT00641537|E11|Reported Event|Cladribine Low/Low Dose (LLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391880|NCT00641537|E10|Reported Event|Cladribine High Dose/Placebo (HLPP) (24-week Follow-up Period|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
391882|NCT00641537|E8|Reported Event|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391883|NCT00641537|E7|Reported Event|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391884|NCT00641537|E6|Reported Event|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
391885|NCT00641537|E5|Reported Event|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391886|NCT00641537|E4|Reported Event|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391887|NCT00641537|E3|Reported Event|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391888|NCT00641537|E2|Reported Event|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391889|NCT00641537|E1|Reported Event|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
391890|NCT00641056|B3|Baseline|Total|Total of all reporting groups
391891|NCT00641056|B2|Baseline|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391892|NCT00641056|B1|Baseline|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391893|NCT00641056|P2|Participant Flow|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391894|NCT00641056|P1|Participant Flow|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391895|NCT00641056|O4|Outcome|Insulin Glargine No SU|Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.
391896|NCT00641056|O3|Outcome|Exenatide Once Weekly No SU|Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.
391897|NCT00641056|O2|Outcome|Insulin Glargine With SU|Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.
391898|NCT00641056|O1|Outcome|Exenatide Once Weekly With SU|Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.
391899|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391900|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391901|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391902|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391903|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391905|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391906|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391907|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391908|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391909|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391910|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391911|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391912|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391913|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391914|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391915|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391916|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391917|NCT00641056|E2|Reported Event|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
391918|NCT00641056|E1|Reported Event|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
391919|NCT00641043|B3|Baseline|Total|Total of all reporting groups
391920|NCT00641043|B2|Baseline|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391921|NCT00641043|B1|Baseline|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391922|NCT00641043|P2|Participant Flow|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391923|NCT00641043|P1|Participant Flow|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391924|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391925|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391926|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391927|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391928|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391929|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391930|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391931|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391932|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391933|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391934|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391935|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391936|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391937|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391938|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391939|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391940|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391941|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
392001|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
391944|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391945|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391946|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391947|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391948|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391949|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391950|NCT00641043|E2|Reported Event|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
391951|NCT00641043|E1|Reported Event|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
391952|NCT00640978|B1|Baseline|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
391953|NCT00640978|P1|Participant Flow|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
391954|NCT00640978|O1|Outcome|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
391955|NCT00640978|E1|Reported Event|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
391956|NCT00640926|B4|Baseline|Total|Total of all reporting groups
391957|NCT00640926|B3|Baseline|Radezolid 450 mg PO Twice Daily (BID)|
391958|NCT00640926|B2|Baseline|Radezolid 450 mg PO Daily (QD)|
391959|NCT00640926|B1|Baseline|Radezolid 300 mg PO Daily (QD)|
391960|NCT00640926|P3|Participant Flow|Radezolid 450 mg PO Twice Daily (BID)|
391961|NCT00640926|P2|Participant Flow|Radezolid 450 mg PO Daily (QD)|
391962|NCT00640926|P1|Participant Flow|Radezolid 300 mg PO Daily (QD)|
391963|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
391964|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
391965|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
391966|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
391967|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
391968|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
391969|NCT00640926|E3|Reported Event|Radezolid 450 mg PO Twice Daily (BID)|
391970|NCT00640926|E2|Reported Event|Radezolid 450 mg PO Daily (QD)|
391971|NCT00640926|E1|Reported Event|Radezolid 300 mg PO Daily (QD)|
391972|NCT00640822|B4|Baseline|Total|Total of all reporting groups
391973|NCT00640822|B3|Baseline|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
391974|NCT00640822|B2|Baseline|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
391975|NCT00640822|B1|Baseline|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
391976|NCT00640822|P3|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
391977|NCT00640822|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
391978|NCT00640822|P1|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
391979|NCT00640822|O3|Outcome|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
391980|NCT00640822|O2|Outcome|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
391981|NCT00640822|O1|Outcome|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
391982|NCT00640822|E3|Reported Event|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
391983|NCT00640822|E2|Reported Event|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
391984|NCT00640822|E1|Reported Event|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
391985|NCT00640614|B3|Baseline|Total|Total of all reporting groups
391986|NCT00640614|B2|Baseline|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
391987|NCT00640614|B1|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
391988|NCT00640614|P2|Participant Flow|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
391989|NCT00640614|P1|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
391990|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
391991|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
391992|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
391993|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
391994|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
391995|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
391996|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
391997|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
391998|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
391999|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
392004|NCT00640614|O3|Outcome|Adhesion|Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.
392005|NCT00640614|O2|Outcome|Itching and Burning|Subject reported sensations of itching and burning were captured at day 2 following patch removal
392006|NCT00640614|O1|Outcome|Panel Irritation|Irritation from the test panel adhesive and/or tape was scored at day 2 following patch removal
392007|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for bronopol and the reference allergen
392008|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bronopol and reference allergen
392009|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for disperse blue and the reference allergen
392010|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for disperse blue and the reference allergen
392011|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for parthenolide and the reference allergen
392012|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for parthenolide and reference allergen
392013|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for bacitracin and the reference allergen
392014|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bacitracin and reference allergen
392015|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for methyldibromo-glutaronitrile and the reference allergen
392016|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for methyldibromo-glutaronitrile and reference allergen
392017|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for hydrocortisone-17-butyrate and the reference allergen
392018|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for hydrocortisone-17-butyrate and reference allergen
392019|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for gold sodium thiosulfate and the reference allergen
392020|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for gold sodium thiosulfate and reference allergen
392021|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392022|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392023|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392024|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392025|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392026|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392027|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
392028|NCT00640614|E2|Reported Event|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
392029|NCT00640614|E1|Reported Event|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
392030|NCT00640601|B1|Baseline|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392031|NCT00640601|P1|Participant Flow|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392032|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392033|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392034|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392035|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392036|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392120|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392121|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392037|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392038|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392039|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392040|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392041|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392042|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392043|NCT00640601|E1|Reported Event|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
392044|NCT00640562|B3|Baseline|Total|Total of all reporting groups
392045|NCT00640562|B2|Baseline|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392046|NCT00640562|B1|Baseline|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392047|NCT00640562|P2|Participant Flow|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392048|NCT00640562|P1|Participant Flow|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392049|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392050|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392051|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392052|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392053|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392122|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392703|NCT00639379|O2|Outcome|Alphafilcon A Toric|
392054|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392055|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392056|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392057|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392058|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392059|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392060|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392061|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392062|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392063|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392064|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392065|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392066|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392067|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392068|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392069|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392164|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392070|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392071|NCT00640562|E2|Reported Event|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
392072|NCT00640562|E1|Reported Event|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
392073|NCT00640510|B3|Baseline|Total|Total of all reporting groups
392074|NCT00640510|B2|Baseline|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392075|NCT00640510|B1|Baseline|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392076|NCT00640510|P2|Participant Flow|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392077|NCT00640510|P1|Participant Flow|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392078|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392079|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392080|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392081|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392082|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392083|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392084|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392085|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392086|NCT00640510|E2|Reported Event|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392087|NCT00640510|E1|Reported Event|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
392088|NCT00640393|B1|Baseline|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392089|NCT00640393|P3|Participant Flow|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392090|NCT00640393|P2|Participant Flow|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392091|NCT00640393|P1|Participant Flow|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392092|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392093|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392094|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392095|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392096|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392097|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392098|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392099|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392100|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392101|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392102|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392103|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392104|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392105|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392106|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392107|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392108|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392109|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392110|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392111|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392112|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392113|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392114|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392115|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392116|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392117|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392118|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392119|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392704|NCT00639379|O1|Outcome|Senofilcon A Toric|
392705|NCT00639379|O2|Outcome|Alphafilcon A Toric|
392123|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392124|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392125|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392126|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392127|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392128|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392129|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392130|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392131|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392132|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392133|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392134|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392135|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392136|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392137|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392138|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392139|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392140|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392141|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392142|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392143|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392144|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392145|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392146|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392147|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392148|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392149|NCT00640393|E3|Reported Event|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
392150|NCT00640393|E2|Reported Event|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
392151|NCT00640393|E1|Reported Event|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
392152|NCT00640341|B4|Baseline|Total|Total of all reporting groups
392153|NCT00640341|B3|Baseline|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392154|NCT00640341|B2|Baseline|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392155|NCT00640341|B1|Baseline|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392156|NCT00640341|P3|Participant Flow|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392157|NCT00640341|P2|Participant Flow|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392158|NCT00640341|P1|Participant Flow|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392159|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392160|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392161|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392162|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392163|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392165|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392166|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392167|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392168|NCT00640341|E3|Reported Event|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
392169|NCT00640341|E2|Reported Event|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
392170|NCT00640341|E1|Reported Event|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
392171|NCT00640328|B7|Baseline|Total|Total of all reporting groups
392172|NCT00640328|B6|Baseline|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392173|NCT00640328|B5|Baseline|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392174|NCT00640328|B4|Baseline|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392175|NCT00640328|B3|Baseline|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392176|NCT00640328|B2|Baseline|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392177|NCT00640328|B1|Baseline|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392178|NCT00640328|P6|Participant Flow|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392179|NCT00640328|P5|Participant Flow|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392180|NCT00640328|P4|Participant Flow|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392181|NCT00640328|P3|Participant Flow|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392182|NCT00640328|P2|Participant Flow|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392183|NCT00640328|P1|Participant Flow|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392360|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392706|NCT00639379|O1|Outcome|Senofilcon A Toric|
392184|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392185|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392186|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392187|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392188|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392189|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392190|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392191|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392192|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392193|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392194|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392195|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392196|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392197|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392198|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392199|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392200|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392201|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392202|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392203|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392204|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392205|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392206|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392207|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392208|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392209|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392210|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392211|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392212|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392213|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392214|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392215|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392216|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392217|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392218|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392219|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392220|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392253|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392221|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392222|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392223|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392224|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392225|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392226|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392227|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392228|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392229|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392230|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392231|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392232|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392233|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392234|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392235|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392254|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392710|NCT00639223|B2|Baseline|Red Yeast Rice|
392711|NCT00639223|B1|Baseline|Pravastatin|
392236|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392237|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392238|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392239|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392240|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392241|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392242|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392243|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392244|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392245|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392246|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392247|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392248|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392249|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392250|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392251|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392252|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392712|NCT00639223|P2|Participant Flow|Red Yeast Rice|
392255|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392256|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
392257|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392258|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392259|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
392260|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
392261|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
392262|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392263|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392264|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392265|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392266|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392267|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392268|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392361|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392269|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392270|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392271|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392272|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392273|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392274|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392275|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
392276|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392277|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392278|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392279|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392362|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392363|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392280|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392281|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392282|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392283|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392284|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392285|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392286|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392287|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392288|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392289|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392290|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392313|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392291|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392292|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392293|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392294|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392295|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392296|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392297|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392298|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392299|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392300|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392301|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392352|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392353|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392510|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392302|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392303|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392304|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392305|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392306|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392307|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392308|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392309|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392310|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392311|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392312|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392354|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392355|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392314|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392315|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392316|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392317|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392318|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392319|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392320|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392321|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392322|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392323|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392324|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392356|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392357|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392325|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392326|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392327|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392328|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392329|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392330|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392331|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392332|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392333|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392334|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392335|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392358|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392359|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392713|NCT00639223|P1|Participant Flow|Pravastatin|
392714|NCT00639223|O2|Outcome|Red Yeast Rice|
392336|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392337|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392338|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392339|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392340|NCT00640328|E6|Reported Event|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392341|NCT00640328|E5|Reported Event|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392342|NCT00640328|E4|Reported Event|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392343|NCT00640328|E3|Reported Event|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392344|NCT00640328|E2|Reported Event|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392345|NCT00640328|E1|Reported Event|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
392346|NCT00640315|B3|Baseline|Total|Total of all reporting groups
392347|NCT00640315|B2|Baseline|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392348|NCT00640315|B1|Baseline|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392349|NCT00640315|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392350|NCT00640315|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392351|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392364|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392365|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392366|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392367|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392368|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392369|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392370|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392371|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392372|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392373|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392374|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392375|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392376|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392377|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392378|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392379|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392380|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392381|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392382|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392383|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392384|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392385|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392386|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392387|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392388|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392389|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392390|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392391|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392392|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392393|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392394|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392395|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392396|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392397|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392398|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392399|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392400|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392401|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392402|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392403|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392404|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392715|NCT00639223|O1|Outcome|Pravastatin|
392405|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392406|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392407|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392408|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392409|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392410|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392411|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392412|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392413|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392414|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392415|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392416|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392417|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392418|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392419|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392420|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392421|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392422|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392423|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392424|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392425|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392426|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392427|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392428|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392429|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392430|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392431|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392432|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392433|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392434|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392435|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392436|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392437|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392438|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392439|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392440|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392441|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392442|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392443|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392444|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392445|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392716|NCT00639223|O2|Outcome|Red Yeast Rice|
392446|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392447|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392448|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392449|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392450|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392451|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392452|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392453|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392454|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392455|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392456|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392457|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392458|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392459|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392460|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392461|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392462|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392463|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392464|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392465|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392466|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392467|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392468|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392469|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392470|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392471|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392472|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392473|NCT00640315|E2|Reported Event|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
392474|NCT00640315|E1|Reported Event|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
392475|NCT00640042|B1|Baseline|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392476|NCT00640042|P1|Participant Flow|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392477|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392478|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392511|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392717|NCT00639223|O1|Outcome|Pravastatin|
392479|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392480|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392481|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392482|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392483|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392484|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392485|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392486|NCT00640042|E1|Reported Event|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
392487|NCT00640016|B5|Baseline|Total|Total of all reporting groups
392488|NCT00640016|B4|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392489|NCT00640016|B3|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392490|NCT00640016|B2|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392491|NCT00640016|B1|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
392492|NCT00640016|P4|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392493|NCT00640016|P3|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392494|NCT00640016|P2|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392495|NCT00640016|P1|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
392496|NCT00640016|O4|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392497|NCT00640016|O3|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392498|NCT00640016|O2|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392499|NCT00640016|O1|Outcome|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
392500|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392501|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392502|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392503|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392504|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392505|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392506|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392507|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392508|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392509|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392512|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392513|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392514|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392515|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392516|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392517|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392518|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392519|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392520|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392521|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392522|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392523|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392524|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392525|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392526|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392527|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392528|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392529|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392530|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392531|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392532|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392533|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392534|NCT00640016|E4|Reported Event|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392535|NCT00640016|E3|Reported Event|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392536|NCT00640016|E2|Reported Event|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
392537|NCT00640016|E1|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
392538|NCT00639860|B1|Baseline|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392539|NCT00639860|P1|Participant Flow|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392540|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392541|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392542|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392543|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392544|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392545|NCT00639860|E1|Reported Event|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
392546|NCT00639769|B1|Baseline|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
392547|NCT00639769|P1|Participant Flow|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
392548|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
392549|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
392550|NCT00639769|E1|Reported Event|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
392551|NCT00639717|B1|Baseline|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392552|NCT00639717|P1|Participant Flow|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392553|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392554|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392555|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392556|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392557|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392558|NCT00639717|E1|Reported Event|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
392559|NCT00639678|B5|Baseline|Total|Total of all reporting groups
392560|NCT00639678|B4|Baseline|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392561|NCT00639678|B3|Baseline|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392562|NCT00639678|B2|Baseline|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392563|NCT00639678|B1|Baseline|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392564|NCT00639678|P4|Participant Flow|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392565|NCT00639678|P3|Participant Flow|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392566|NCT00639678|P2|Participant Flow|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392707|NCT00639379|E2|Reported Event|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
392567|NCT00639678|P1|Participant Flow|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392568|NCT00639678|O1|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392569|NCT00639678|O1|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392570|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392571|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392572|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392573|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392574|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392575|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392576|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392577|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392578|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392579|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392580|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392581|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392582|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392583|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392584|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392585|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392586|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392587|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392588|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392589|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392590|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392591|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392592|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392708|NCT00639379|E1|Reported Event|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
392593|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392594|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392595|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392596|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392597|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392598|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392599|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392600|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392601|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392602|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392603|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392604|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392605|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392606|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392607|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392608|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392609|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392610|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392611|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392612|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392613|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392614|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392615|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392616|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392617|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392618|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392655|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392619|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392620|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392621|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392622|NCT00639678|E4|Reported Event|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392623|NCT00639678|E3|Reported Event|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
392624|NCT00639678|E2|Reported Event|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
392625|NCT00639678|E1|Reported Event|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
392626|NCT00639509|B1|Baseline|IMC-A12|Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
392627|NCT00639509|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
392628|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
392629|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
392630|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
392631|NCT00639509|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
392632|NCT00639457|B3|Baseline|Total|Total of all reporting groups
392633|NCT00639457|B2|Baseline|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392634|NCT00639457|B1|Baseline|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392635|NCT00639457|P2|Participant Flow|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392636|NCT00639457|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392637|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392638|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392639|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392640|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392641|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392642|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392643|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392644|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392645|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392646|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392647|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392648|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392649|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392650|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392651|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392652|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392653|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392654|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392709|NCT00639223|B3|Baseline|Total|Total of all reporting groups
392657|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392658|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392659|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392660|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392661|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392662|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392663|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392664|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392665|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392666|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392667|NCT00639457|E2|Reported Event|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
392668|NCT00639457|E1|Reported Event|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
392669|NCT00639418|B5|Baseline|Total|Total of all reporting groups
392670|NCT00639418|B4|Baseline|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
392671|NCT00639418|B3|Baseline|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
392672|NCT00639418|B2|Baseline|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
392673|NCT00639418|B1|Baseline|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
392674|NCT00639418|P4|Participant Flow|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
392675|NCT00639418|P3|Participant Flow|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
392676|NCT00639418|P2|Participant Flow|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
392677|NCT00639418|P1|Participant Flow|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
392678|NCT00639418|O4|Outcome|Staff Attitudes: Number of Doses|Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine
392679|NCT00639418|O3|Outcome|Staff Attitudes: 5 to 18 Year Old Patients|Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year
392680|NCT00639418|O2|Outcome|Staff Attitudes: 6 Months to 5 Year Old Patients|Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
392681|NCT00639418|O1|Outcome|Staff Attitudes: High-risk Medical Conditions|Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
392682|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
392683|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
392684|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
392685|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
392686|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
392687|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
392688|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
392689|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
392690|NCT00639418|E4|Reported Event|Children 9 to 18 Years|AEs were not collected in this observational study of physician vaccination practices.
392691|NCT00639418|E3|Reported Event|Children 5 to 8 Years|AEs were not collected in this observational study of physician vaccination practices.
392692|NCT00639418|E2|Reported Event|Children 24 to 59 Months|AEs were not collected in this observational study of physician vaccination practices.
392693|NCT00639418|E1|Reported Event|Children 6 to 23 Months|AEs were not collected in this observational study of physician vaccination practices.
392694|NCT00639379|B1|Baseline|Total Completed Participants|
392695|NCT00639379|P2|Participant Flow|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
392696|NCT00639379|P1|Participant Flow|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
392697|NCT00639379|O2|Outcome|Alphafilcon A Toric|
392718|NCT00639223|E2|Reported Event|Red Yeast Rice|
392719|NCT00639223|E1|Reported Event|Pravastatin|
392720|NCT00639158|B3|Baseline|Total|Total of all reporting groups
392721|NCT00639158|B2|Baseline|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392722|NCT00639158|B1|Baseline|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392723|NCT00639158|P2|Participant Flow|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392724|NCT00639158|P1|Participant Flow|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392725|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392726|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392727|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392728|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392729|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392730|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392731|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392732|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392733|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392734|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392735|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392736|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392737|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392738|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392739|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392740|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392741|NCT00639158|E2|Reported Event|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
392742|NCT00639158|E1|Reported Event|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
392743|NCT00639093|B3|Baseline|Total|Total of all reporting groups
392744|NCT00639093|B2|Baseline|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
392745|NCT00639093|B1|Baseline|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
392746|NCT00639093|P2|Participant Flow|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
392747|NCT00639093|P1|Participant Flow|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
392748|NCT00639093|O2|Outcome|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
392749|NCT00639093|O1|Outcome|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
392750|NCT00639093|E2|Reported Event|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
392751|NCT00639093|E1|Reported Event|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
392752|NCT00639002|B1|Baseline|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
392753|NCT00639002|P1|Participant Flow|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
392789|NCT00638937|E1|Reported Event|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
392790|NCT00638924|B1|Baseline|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
394212|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
392754|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
392755|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
392756|NCT00639002|E2|Reported Event|Ruxolitinib + Dexamethasone|Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
392757|NCT00639002|E1|Reported Event|Ruxolitinib|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
392758|NCT00638963|B3|Baseline|Total|Total of all reporting groups
392759|NCT00638963|B2|Baseline|Observational|No temozolomide treatment
392760|NCT00638963|B1|Baseline|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392761|NCT00638963|P2|Participant Flow|Observational|No temozolomide treatment
392762|NCT00638963|P1|Participant Flow|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392763|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392764|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392765|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392766|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392767|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392768|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
392769|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392770|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
392771|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392772|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
392773|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392774|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
392775|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392776|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
392777|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392778|NCT00638963|E2|Reported Event|Observational|No temozolomide treatment
392779|NCT00638963|E1|Reported Event|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
392780|NCT00638937|B1|Baseline|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
392781|NCT00638937|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: 175mg given PO daily~laboratory biomarker analysis: Correlative studies"
392782|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392783|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392784|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392785|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392786|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392787|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
392788|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
392791|NCT00638924|P1|Participant Flow|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
392792|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
392793|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
392794|NCT00638924|E1|Reported Event|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
392795|NCT00638885|B1|Baseline|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
392796|NCT00638885|P1|Participant Flow|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
392797|NCT00638885|O1|Outcome|Vietnam Veteran Twins|Vietnam veteran twins with and without PTSD.
392798|NCT00638885|E1|Reported Event|Vietnam Twins With and Without PTSD|
392799|NCT00638846|B3|Baseline|Total|Total of all reporting groups
392800|NCT00638846|B2|Baseline|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392801|NCT00638846|B1|Baseline|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392802|NCT00638846|P2|Participant Flow|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392803|NCT00638846|P1|Participant Flow|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392804|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392805|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392806|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392807|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392808|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392809|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392810|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392811|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392812|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392813|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392814|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392815|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392816|NCT00638846|E2|Reported Event|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
392817|NCT00638846|E1|Reported Event|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
392818|NCT00638820|B1|Baseline|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392819|NCT00638820|P1|Participant Flow|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392820|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392821|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392822|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392823|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392824|NCT00638820|E1|Reported Event|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
392825|NCT00638690|B3|Baseline|Total|Total of all reporting groups
392826|NCT00638690|B2|Baseline|Placebo|Placebo plus prednisone/prednisolone
392827|NCT00638690|B1|Baseline|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392828|NCT00638690|P2|Participant Flow|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
392829|NCT00638690|P1|Participant Flow|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392830|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
392831|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392832|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
392833|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392834|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
392835|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392836|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
392837|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392838|NCT00638690|E3|Reported Event|Placebo to Abiraterone Acetate|Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
392839|NCT00638690|E2|Reported Event|Placebo|Placebo plus prednisone/prednisolone
392840|NCT00638690|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
392841|NCT00638651|B3|Baseline|Total|Total of all reporting groups
392842|NCT00638651|B2|Baseline|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
392843|NCT00638651|B1|Baseline|Laser Treatment With Imiquimod Cream (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
392844|NCT00638651|P2|Participant Flow|Laser Treatment With Placebo Cream (Group 2)|The tattoo will be treated with laser and placebo topical cream
392845|NCT00638651|P1|Participant Flow|Laser Treatment With Imiquimod Cream (Group 1)|The tattoo will be treated with laser and imiquimod 5% cream
392846|NCT00638651|O2|Outcome|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
392847|NCT00638651|O1|Outcome|Laser Treatment With Imiquimod (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
392848|NCT00638651|E2|Reported Event|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
392849|NCT00638651|E1|Reported Event|Laser Treatment With Imiquimod Cream (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
392850|NCT00638443|B1|Baseline|All Study Participants|"Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days~Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days"
392851|NCT00638443|P2|Participant Flow|Diphenhydramine First, Pregabalin Second|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
392852|NCT00638443|P1|Participant Flow|Pregabalin First, Diphenhydramine Second|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392853|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392854|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392855|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392856|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392857|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392858|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392859|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392860|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392861|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392862|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392863|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392864|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392865|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392866|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392867|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392868|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392869|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392870|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392871|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392872|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392873|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
392874|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
392875|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
392876|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
392877|NCT00638443|E2|Reported Event|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
392878|NCT00638443|E1|Reported Event|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
392879|NCT00638378|B1|Baseline|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392880|NCT00638378|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392881|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392882|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392883|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392884|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392885|NCT00638378|E1|Reported Event|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
392886|NCT00638365|B4|Baseline|Total|Total of all reporting groups
392887|NCT00638365|B3|Baseline|KB001, 10 mg/kg|
392888|NCT00638365|B2|Baseline|KB001, 3 mg/kg|
392889|NCT00638365|B1|Baseline|Placebo|
392890|NCT00638365|P3|Participant Flow|KB001, 10 mg/kg|
392891|NCT00638365|P2|Participant Flow|KB001, 3 mg/kg|
392892|NCT00638365|P1|Participant Flow|Placebo|
392893|NCT00638365|O3|Outcome|KB001, 10 mg/kg|
392894|NCT00638365|O2|Outcome|KB001, 3 mg/kg|
392895|NCT00638365|O1|Outcome|Placebo|
392896|NCT00638365|E3|Reported Event|KB001, 10 mg/kg|
392897|NCT00638365|E2|Reported Event|KB001, 3 mg/kg|
392898|NCT00638365|E1|Reported Event|Placebo|
392899|NCT00638235|B10|Baseline|Total|Total of all reporting groups
392900|NCT00638235|B9|Baseline|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392901|NCT00638235|B8|Baseline|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
392902|NCT00638235|B7|Baseline|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392903|NCT00638235|B6|Baseline|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392904|NCT00638235|B5|Baseline|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392905|NCT00638235|B4|Baseline|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392906|NCT00638235|B3|Baseline|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
392907|NCT00638235|B2|Baseline|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
394897|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
392908|NCT00638235|B1|Baseline|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392909|NCT00638235|P9|Participant Flow|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392910|NCT00638235|P8|Participant Flow|Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
392911|NCT00638235|P7|Participant Flow|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392912|NCT00638235|P6|Participant Flow|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392913|NCT00638235|P5|Participant Flow|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392914|NCT00638235|P4|Participant Flow|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392915|NCT00638235|P3|Participant Flow|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392916|NCT00638235|P2|Participant Flow|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392917|NCT00638235|P1|Participant Flow|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392918|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392919|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
392920|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392921|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392922|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392923|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392924|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
392925|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392926|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392927|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392928|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
392929|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392930|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392931|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392932|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392933|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392934|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392935|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392936|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392937|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
392938|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392939|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392940|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392941|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392942|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
392943|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392944|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392945|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392946|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
392947|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392948|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392949|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392950|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392951|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392952|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392953|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392954|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392955|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
392956|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392957|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392958|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392959|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392960|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
392961|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392962|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392963|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392964|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
392965|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392966|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392967|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392968|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392969|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392970|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392971|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392972|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392973|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only)
392974|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392975|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392976|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392977|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392978|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392979|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392980|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392981|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392982|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
392983|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392984|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392985|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392986|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392987|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
392988|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392989|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392990|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
392991|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
392992|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
392993|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
392994|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392995|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
392996|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
392997|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
392998|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
392999|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393000|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393001|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393002|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393003|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393004|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393005|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393006|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393007|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393008|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393009|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393010|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393011|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393012|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393013|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393014|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels"
393015|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393016|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393017|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393018|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393019|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393020|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393021|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393022|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393023|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393024|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393025|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393026|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393027|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393028|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393029|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393030|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393031|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393032|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393033|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393034|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393035|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393164|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393036|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393037|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393038|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393039|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393040|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393041|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393042|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393043|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393044|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393045|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393046|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393047|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393048|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393049|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393050|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393051|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393052|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393053|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393054|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393055|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393056|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393057|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393058|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393059|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393060|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393061|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393062|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393063|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393064|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393065|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393066|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393162|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393067|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393068|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393069|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393070|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393071|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393072|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393073|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393074|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393075|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393076|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393077|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393078|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393079|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393080|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393081|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393082|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393083|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393084|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393085|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393086|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393087|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393088|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393089|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393090|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393091|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393092|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393093|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393094|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393095|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393096|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393097|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393098|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393163|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393099|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393100|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393101|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393102|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393103|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393104|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393105|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393106|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393107|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393108|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393109|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393110|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393111|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393112|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393113|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393114|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393115|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393116|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393117|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393118|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393119|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393120|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393121|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393122|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393123|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393124|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393125|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393126|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393127|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393128|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393129|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393546|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393130|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393131|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393132|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393133|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393134|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393135|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393136|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393137|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393138|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393139|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393140|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393141|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393142|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393143|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393144|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393145|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393146|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393147|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393148|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393149|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393150|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393151|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393152|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393153|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393154|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393155|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393156|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393157|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393158|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393159|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393160|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393161|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
394898|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
393165|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393166|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393167|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393168|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393169|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393170|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393171|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393172|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393173|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393174|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393175|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393176|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393177|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393178|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393179|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393180|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393181|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393182|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393183|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393184|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393185|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393186|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393187|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393188|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393189|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393190|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393191|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393192|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393193|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393194|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393195|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393196|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393197|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393198|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393199|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393200|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393201|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393202|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393203|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393204|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393205|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393206|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393207|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393208|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393209|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393210|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393211|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393212|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393213|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393214|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393215|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393216|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393217|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393218|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393219|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393220|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393221|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393222|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393223|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393224|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393225|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393226|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US & Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393227|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393966|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393228|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393229|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393230|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393231|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393232|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393233|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393234|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393235|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393236|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393237|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393238|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393239|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393240|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393241|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393242|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393243|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393244|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393245|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393246|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393247|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393248|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV"
393249|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393250|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393251|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393252|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393253|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393254|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393255|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393256|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393257|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393258|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393259|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393260|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393261|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393262|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393263|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393264|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393265|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393266|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393267|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393268|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393269|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393270|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393271|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393272|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393273|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393274|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393275|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393276|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393277|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393278|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393279|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393280|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393281|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393282|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393283|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393284|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393285|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393286|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393287|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393288|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
393289|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393290|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393442|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393291|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393292|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393293|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393294|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393295|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393296|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393297|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
393298|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393299|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393300|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393301|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393302|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
393303|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393304|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393305|NCT00638235|E9|Reported Event|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
393306|NCT00638235|E8|Reported Event|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
393307|NCT00638235|E7|Reported Event|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
393308|NCT00638235|E6|Reported Event|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
393309|NCT00638235|E5|Reported Event|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393310|NCT00638235|E4|Reported Event|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
393311|NCT00638235|E3|Reported Event|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
393312|NCT00638235|E2|Reported Event|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
393313|NCT00638235|E1|Reported Event|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
393314|NCT00638222|B4|Baseline|Total|Total of all reporting groups
393315|NCT00638222|B3|Baseline|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
393316|NCT00638222|B2|Baseline|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
393317|NCT00638222|B1|Baseline|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
393318|NCT00638222|P3|Participant Flow|All Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
393319|NCT00638222|P2|Participant Flow|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
393320|NCT00638222|P1|Participant Flow|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
393321|NCT00638222|O2|Outcome|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
393322|NCT00638222|O1|Outcome|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
393323|NCT00638222|E3|Reported Event|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
393324|NCT00638222|E2|Reported Event|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
393325|NCT00638222|E1|Reported Event|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
393326|NCT00638183|B1|Baseline|Spiriva Treatment|Daily Therapy
393327|NCT00638183|P1|Participant Flow|Spiriva Treatment|Daily Therapy
393328|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
393329|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
393330|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
393331|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
393332|NCT00638183|E1|Reported Event|Spiriva Treatment|Daily Therapy
393333|NCT00638157|B3|Baseline|Total|Total of all reporting groups
393334|NCT00638157|B2|Baseline|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
393335|NCT00638157|B1|Baseline|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
393336|NCT00638157|P2|Participant Flow|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
393337|NCT00638157|P1|Participant Flow|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
393338|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
393339|NCT00638157|O1|Outcome|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
393340|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
393341|NCT00638157|O1|Outcome|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
393342|NCT00638157|E2|Reported Event|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
393343|NCT00638157|E1|Reported Event|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
393344|NCT00638027|B3|Baseline|Total|Total of all reporting groups
393345|NCT00638027|B2|Baseline|Placebo|Placebo arm
393346|NCT00638027|B1|Baseline|Memantine|Memantine 10 mg bid
393347|NCT00638027|P2|Participant Flow|Placebo|Placebo arm
393348|NCT00638027|P1|Participant Flow|Memantine|Memantine 10 mg bid
393349|NCT00638027|O2|Outcome|Placebo|Placebo arm
393350|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
393351|NCT00638027|O2|Outcome|Placebo|Placebo arm
393352|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
393353|NCT00638027|O2|Outcome|Placebo|Placebo arm
393354|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
393355|NCT00638027|E2|Reported Event|Placebo|Placebo arm
393356|NCT00638027|E1|Reported Event|Memantine|Memantine 10 mg bid
393357|NCT00638014|B3|Baseline|Total|Total of all reporting groups
393358|NCT00638014|B2|Baseline|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
393359|NCT00638014|B1|Baseline|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
393360|NCT00638014|P2|Participant Flow|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
393361|NCT00638014|P1|Participant Flow|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
393362|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
393363|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
393364|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
393365|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
393366|NCT00638014|E2|Reported Event|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
393367|NCT00638014|E1|Reported Event|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
393368|NCT00637923|B3|Baseline|Total|Total of all reporting groups
393369|NCT00637923|B2|Baseline|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393370|NCT00637923|B1|Baseline|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393371|NCT00637923|P2|Participant Flow|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393372|NCT00637923|P1|Participant Flow|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393373|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393374|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393375|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393376|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393377|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393378|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393379|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393380|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393381|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393382|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393383|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393384|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393385|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393386|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393387|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393388|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393389|NCT00637923|E2|Reported Event|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393390|NCT00637923|E1|Reported Event|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
393391|NCT00637806|B4|Baseline|Total|Total of all reporting groups
393392|NCT00637806|B3|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393393|NCT00637806|B2|Baseline|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393394|NCT00637806|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393395|NCT00637806|P4|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
393396|NCT00637806|P3|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393397|NCT00637806|P2|Participant Flow|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393398|NCT00637806|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
393399|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393400|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393401|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393402|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393403|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393404|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393405|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393406|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393407|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393408|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393409|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393410|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393411|NCT00637806|E4|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
393412|NCT00637806|E3|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393413|NCT00637806|E2|Reported Event|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
393414|NCT00637806|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393415|NCT00637728|B3|Baseline|Total|Total of all reporting groups
393416|NCT00637728|B2|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393417|NCT00637728|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393418|NCT00637728|P3|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
393419|NCT00637728|P2|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393420|NCT00637728|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
393421|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393422|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393423|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393424|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393425|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393426|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393427|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393428|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393429|NCT00637728|E3|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
393430|NCT00637728|E2|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
393431|NCT00637728|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
393432|NCT00637572|B3|Baseline|Total|Total of all reporting groups
393433|NCT00637572|B2|Baseline|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per as single-dose for 12 weeks
393434|NCT00637572|B1|Baseline|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per as single-dose for 12 weeks
393435|NCT00637572|P2|Participant Flow|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393436|NCT00637572|P1|Participant Flow|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393437|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393438|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393439|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393440|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393441|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393545|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393443|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393444|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393445|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393446|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393447|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393448|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393449|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393450|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393451|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393452|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393453|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393454|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393455|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393456|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393457|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
393458|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
393459|NCT00637572|E2|Reported Event|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single dose for 12 weeks
393460|NCT00637572|E1|Reported Event|Megestrol Acetate Oral Suspension NanoCrystal Dispersion|Subjects were treated with 575 mg per day as single dose for 12 weeks
393461|NCT00637494|B3|Baseline|Total|Total of all reporting groups
393462|NCT00637494|B2|Baseline|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
393463|NCT00637494|B1|Baseline|Mifepristone Followed by an Antidepressant|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
393464|NCT00637494|P2|Participant Flow|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
393465|NCT00637494|P1|Participant Flow|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
393466|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
393467|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
393468|NCT00637494|E2|Reported Event|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
393469|NCT00637494|E1|Reported Event|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
393470|NCT00637416|B3|Baseline|Total|Total of all reporting groups
393471|NCT00637416|B2|Baseline|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
393472|NCT00637416|B1|Baseline|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
393473|NCT00637416|P2|Participant Flow|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
393474|NCT00637416|P1|Participant Flow|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
393475|NCT00637416|O2|Outcome|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
393476|NCT00637416|O1|Outcome|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
393477|NCT00637416|E2|Reported Event|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
393478|NCT00637416|E1|Reported Event|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
393479|NCT00637377|B5|Baseline|Total|Total of all reporting groups
393480|NCT00637377|B4|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393481|NCT00637377|B3|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393482|NCT00637377|B2|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393483|NCT00637377|B1|Baseline|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393484|NCT00637377|P4|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393485|NCT00637377|P3|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393486|NCT00637377|P2|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393487|NCT00637377|P1|Participant Flow|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393488|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393489|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393490|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393491|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393492|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393493|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393494|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393495|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393496|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393497|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393498|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393499|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393500|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393501|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393502|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393503|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393504|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393967|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393505|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393506|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393507|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393508|NCT00637377|E4|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393509|NCT00637377|E3|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393510|NCT00637377|E2|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393511|NCT00637377|E1|Reported Event|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
393512|NCT00637312|B3|Baseline|Total|Total of all reporting groups
393513|NCT00637312|B2|Baseline|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
393514|NCT00637312|B1|Baseline|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
393515|NCT00637312|P2|Participant Flow|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
393516|NCT00637312|P1|Participant Flow|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
393517|NCT00637312|O2|Outcome|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
393518|NCT00637312|O1|Outcome|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
393519|NCT00637312|E2|Reported Event|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
393520|NCT00637312|E1|Reported Event|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
393521|NCT00637299|B3|Baseline|Total|Total of all reporting groups
393522|NCT00637299|B2|Baseline|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
393523|NCT00637299|B1|Baseline|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
393524|NCT00637299|P2|Participant Flow|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
393525|NCT00637299|P1|Participant Flow|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
393526|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
393527|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
393528|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
393529|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
393530|NCT00637299|E2|Reported Event|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
393531|NCT00637299|E1|Reported Event|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
393532|NCT00637273|B4|Baseline|Total|Total of all reporting groups
393533|NCT00637273|B3|Baseline|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393534|NCT00637273|B2|Baseline|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393535|NCT00637273|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393536|NCT00637273|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393537|NCT00637273|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393538|NCT00637273|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393539|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393540|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393541|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393542|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393543|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393544|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
394899|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
393547|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393548|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393549|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393550|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393551|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393552|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393553|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393554|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393555|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393556|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393557|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393558|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393559|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393560|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393561|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393562|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393563|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393564|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393565|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393566|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393567|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393568|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393569|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393570|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393571|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393572|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393573|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393574|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393575|NCT00637273|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393576|NCT00637273|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
393577|NCT00637273|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
393578|NCT00637247|B3|Baseline|Total|Total of all reporting groups
393579|NCT00637247|B2|Baseline|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393580|NCT00637247|B1|Baseline|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393581|NCT00637247|P2|Participant Flow|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393582|NCT00637247|P1|Participant Flow|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393583|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393584|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393585|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393586|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393587|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393588|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393589|NCT00637247|E2|Reported Event|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
393590|NCT00637247|E1|Reported Event|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
393591|NCT00637195|B3|Baseline|Total|Total of all reporting groups
393592|NCT00637195|B2|Baseline|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393593|NCT00637195|B1|Baseline|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393594|NCT00637195|P2|Participant Flow|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393595|NCT00637195|P1|Participant Flow|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393596|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
394900|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
393597|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393598|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393599|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393600|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393601|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393602|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393603|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393604|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393605|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393606|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393607|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393608|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393609|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393610|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393611|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393612|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393613|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393614|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393615|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393616|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393617|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393618|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393619|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393620|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393621|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393622|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393623|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393624|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393625|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393626|NCT00637195|E2|Reported Event|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
393627|NCT00637195|E1|Reported Event|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
393628|NCT00637156|B3|Baseline|Total|Total of all reporting groups
393629|NCT00637156|B2|Baseline|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393630|NCT00637156|B1|Baseline|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393631|NCT00637156|P2|Participant Flow|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393632|NCT00637156|P1|Participant Flow|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393968|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393633|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393634|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393635|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393636|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393637|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393638|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393639|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393640|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393641|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393642|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393643|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393644|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393645|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393646|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393647|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393648|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393649|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393650|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393651|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393652|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393653|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393654|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393655|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393656|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393657|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393658|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393969|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393659|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393660|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393661|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393662|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393663|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393664|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393665|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393666|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393667|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393668|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393669|NCT00637156|E2|Reported Event|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
393670|NCT00637156|E1|Reported Event|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
393671|NCT00637000|B3|Baseline|Total|Total of all reporting groups
393672|NCT00637000|B2|Baseline|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393673|NCT00637000|B1|Baseline|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393674|NCT00637000|P2|Participant Flow|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393675|NCT00637000|P1|Participant Flow|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393676|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393677|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393678|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393679|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393680|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393681|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393721|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393682|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393683|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393684|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393685|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393686|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393687|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393688|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393689|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393690|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393691|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393692|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393693|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393694|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393695|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393696|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393697|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393698|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393699|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393700|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393701|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393970|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393702|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393703|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393704|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393705|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393706|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393707|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393708|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393709|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393710|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393711|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393712|NCT00637000|E2|Reported Event|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393713|NCT00637000|E1|Reported Event|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
393714|NCT00636961|B3|Baseline|Total|Total of all reporting groups
393715|NCT00636961|B2|Baseline|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
393716|NCT00636961|B1|Baseline|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
393717|NCT00636961|P2|Participant Flow|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
393718|NCT00636961|P1|Participant Flow|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
393719|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393720|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393722|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393723|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393724|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393725|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393726|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393727|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393728|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393729|NCT00636961|E2|Reported Event|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393730|NCT00636961|E1|Reported Event|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
393731|NCT00636818|B1|Baseline|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393732|NCT00636818|P1|Participant Flow|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393733|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393734|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393735|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393736|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393737|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393738|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393739|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393740|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393741|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393742|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393971|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393743|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393744|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393745|NCT00636818|E1|Reported Event|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
393746|NCT00636805|B1|Baseline|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393747|NCT00636805|P1|Participant Flow|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393748|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393749|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393750|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393751|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393752|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393753|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393754|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393755|NCT00636805|E1|Reported Event|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
393756|NCT00636792|B1|Baseline|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
393757|NCT00636792|P1|Participant Flow|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
393758|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
393759|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
393760|NCT00636792|E1|Reported Event|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
393761|NCT00636701|B3|Baseline|Total|Total of all reporting groups
393762|NCT00636701|B2|Baseline|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393763|NCT00636701|B1|Baseline|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393764|NCT00636701|P2|Participant Flow|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393765|NCT00636701|P1|Participant Flow|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393889|NCT00636363|P2|Participant Flow|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393766|NCT00636701|O2|Outcome|Number of Participants Who Received Unprimed rTMS|Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
393767|NCT00636701|O1|Outcome|Number of Participants Who Received Primed rTMS|Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
393768|NCT00636701|E2|Reported Event|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393769|NCT00636701|E1|Reported Event|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
393770|NCT00636649|B3|Baseline|Total|Total of all reporting groups
393771|NCT00636649|B2|Baseline|Placebo|
393772|NCT00636649|B1|Baseline|Escitalopram|
393773|NCT00636649|P2|Participant Flow|Placebo|Dosing of matching placebo was identical.
393774|NCT00636649|P1|Participant Flow|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393775|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393776|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393777|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393778|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393779|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393780|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393781|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393782|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393783|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393784|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393785|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393786|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393787|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393788|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393789|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393790|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
393791|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393792|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
393793|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393794|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
393795|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
393796|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
393797|NCT00636649|O2|Outcome|Placebo|
393798|NCT00636649|O1|Outcome|Escitalopram|
393799|NCT00636649|E2|Reported Event|Placebo|
393800|NCT00636649|E1|Reported Event|Escitalopram|
393801|NCT00636636|B3|Baseline|Total|Total of all reporting groups
393802|NCT00636636|B2|Baseline|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393803|NCT00636636|B1|Baseline|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393804|NCT00636636|P2|Participant Flow|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393805|NCT00636636|P1|Participant Flow|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393806|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393807|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393808|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393809|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393810|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393811|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393812|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393813|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393814|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393815|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393816|NCT00636636|E2|Reported Event|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
393817|NCT00636636|E1|Reported Event|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
393818|NCT00636610|B3|Baseline|Total|Total of all reporting groups
393842|NCT00636441|P4|Participant Flow|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393890|NCT00636363|P1|Participant Flow|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
396234|NCT00631449|B3|Baseline|Total|Total of all reporting groups
393819|NCT00636610|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393820|NCT00636610|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393821|NCT00636610|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393822|NCT00636610|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393823|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393824|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393825|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393826|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
393827|NCT00636610|E4|Reported Event|Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
393828|NCT00636610|E3|Reported Event|Placebo With FOLFIRI+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
393829|NCT00636610|E2|Reported Event|Vismodegib (GDC-0449) With FOLFOX+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
393830|NCT00636610|E1|Reported Event|Placebo With FOLFOX+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
393831|NCT00636441|B8|Baseline|Total|Total of all reporting groups
393832|NCT00636441|B7|Baseline|Screen Failure|
393833|NCT00636441|B6|Baseline|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393834|NCT00636441|B5|Baseline|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393835|NCT00636441|B4|Baseline|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393836|NCT00636441|B3|Baseline|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393837|NCT00636441|B2|Baseline|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393838|NCT00636441|B1|Baseline|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393839|NCT00636441|P7|Participant Flow|Screen Failure|
393840|NCT00636441|P6|Participant Flow|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393841|NCT00636441|P5|Participant Flow|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393843|NCT00636441|P3|Participant Flow|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393844|NCT00636441|P2|Participant Flow|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393845|NCT00636441|P1|Participant Flow|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393846|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393847|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393848|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393849|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393850|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393851|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393852|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393853|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393854|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393855|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393856|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393857|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393858|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393859|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393860|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393861|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393862|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393863|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393864|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
393865|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
393866|NCT00636441|E7|Reported Event|Screen Failures|Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
393867|NCT00636441|E6|Reported Event|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393868|NCT00636441|E5|Reported Event|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393869|NCT00636441|E4|Reported Event|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393870|NCT00636441|E3|Reported Event|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393871|NCT00636441|E2|Reported Event|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393872|NCT00636441|E1|Reported Event|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
393873|NCT00636389|B1|Baseline|All Study Participants|
393874|NCT00636389|P2|Participant Flow|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
393875|NCT00636389|P1|Participant Flow|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
393876|NCT00636389|O2|Outcome|210H|
393877|NCT00636389|O1|Outcome|HD-C4|
393878|NCT00636389|O2|Outcome|210H|
393879|NCT00636389|O1|Outcome|HD-C4|
393880|NCT00636389|O2|Outcome|210H|
393881|NCT00636389|O1|Outcome|HD-C4|
393882|NCT00636389|E2|Reported Event|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
393883|NCT00636389|E1|Reported Event|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
393884|NCT00636363|B4|Baseline|Total|Total of all reporting groups
393885|NCT00636363|B3|Baseline|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
393886|NCT00636363|B2|Baseline|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393887|NCT00636363|B1|Baseline|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393888|NCT00636363|P3|Participant Flow|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
396318|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
393891|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
393892|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393893|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393894|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
393895|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393896|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393897|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
393898|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393899|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393900|NCT00636363|E3|Reported Event|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
393901|NCT00636363|E2|Reported Event|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393902|NCT00636363|E1|Reported Event|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
393903|NCT00635232|B6|Baseline|Total|Total of all reporting groups
393904|NCT00635232|B5|Baseline|PS433540 800mg|PS433540 800mg once daily
393905|NCT00635232|B4|Baseline|PS433540 400mg|PS433540 400mg once daily
393906|NCT00635232|B3|Baseline|PS433540 200mg|PS433540 200mg once daily
393907|NCT00635232|B2|Baseline|Placebo|Blinded Placebo Treatment
393908|NCT00635232|B1|Baseline|Irbesartan 300mg|Irbesartan 300 mg once daily
393909|NCT00635232|P5|Participant Flow|PS433540 800mg|PS433540 800mg once daily
393910|NCT00635232|P4|Participant Flow|PS433540 400mg|PS433540 400mg once daily
393911|NCT00635232|P3|Participant Flow|PS433540 200mg|PS433540 200mg once daily
393912|NCT00635232|P2|Participant Flow|Placebo|Blinded Placebo Treatment
393913|NCT00635232|P1|Participant Flow|Irbesartan 300mg|Irbesartan 300 mg once daily
393914|NCT00635232|O5|Outcome|PS433540 800mg|
393915|NCT00635232|O4|Outcome|PS433540 400mg|
393916|NCT00635232|O3|Outcome|PS433540 200mg|
393917|NCT00635232|O2|Outcome|Placebo|
393918|NCT00635232|O1|Outcome|Irbesartan 300mg|
393919|NCT00635232|O5|Outcome|PS433540 800mg|
393920|NCT00635232|O4|Outcome|PS433540 400mg|
393921|NCT00635232|O3|Outcome|PS433540 200mg|
393922|NCT00635232|O2|Outcome|Placebo|
393923|NCT00635232|O1|Outcome|Irbesartan 300mg|
393924|NCT00635232|O5|Outcome|PS433540 800mg|
393925|NCT00635232|O4|Outcome|PS433540 400mg|
393926|NCT00635232|O3|Outcome|PS433540 200mg|
393927|NCT00635232|O2|Outcome|Placebo|
393928|NCT00635232|O1|Outcome|Irbesartan 300mg|
393929|NCT00635232|E5|Reported Event|PS433540 800mg|PS433540 800mg once daily
393930|NCT00635232|E4|Reported Event|PS433540 400mg|PS433540 400mg once daily
393931|NCT00635232|E3|Reported Event|PS433540 200mg|PS433540 200mg once daily
393932|NCT00635232|E2|Reported Event|Placebo|Blinded Placebo Treatment
393933|NCT00635232|E1|Reported Event|Irbesartan 300mg|Irbesartan 300 mg once daily
393934|NCT00635219|B6|Baseline|Total|Total of all reporting groups
393935|NCT00635219|B5|Baseline|Duloxetine 60 mg|encapsulated capsules; orally
393936|NCT00635219|B4|Baseline|Vortioxetine 10 mg|encapsulated tablets; orally
393937|NCT00635219|B3|Baseline|Vortioxetine 5 mg|encapsulated tablets; orally
393938|NCT00635219|B2|Baseline|Vortioxetine 2.5 mg|encapsulated tablets; orally
393939|NCT00635219|B1|Baseline|Placebo|capsules; daily; orally
393940|NCT00635219|P5|Participant Flow|Duloxetine 60 mg|encapsulated capsules; orally
393941|NCT00635219|P4|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; orally
393942|NCT00635219|P3|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; orally
393943|NCT00635219|P2|Participant Flow|Vortioxetine 2.5 mg|encapsulated tablets; orally
393944|NCT00635219|P1|Participant Flow|Placebo|capsules; daily; orally
393945|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393946|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393947|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393948|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393949|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393950|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393951|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393952|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393953|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393954|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393955|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393956|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393957|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393958|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393959|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393960|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393961|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393962|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393963|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393964|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393965|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393972|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393973|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393974|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393975|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393976|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393977|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393978|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393979|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393980|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393981|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393982|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393983|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393984|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393985|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393986|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393987|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393988|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393989|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393990|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
393991|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
393992|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
393993|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
393994|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
393995|NCT00635219|E5|Reported Event|Duloxetine 60 mg|
393996|NCT00635219|E4|Reported Event|Vortioxetine 10 mg|
393997|NCT00635219|E3|Reported Event|Vortioxetine 5 mg|
393998|NCT00635219|E2|Reported Event|Vortioxetine 2.5 mg|
393999|NCT00635219|E1|Reported Event|Placebo|
394000|NCT00633477|B3|Baseline|Total|Total of all reporting groups
394001|NCT00633477|B2|Baseline|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394002|NCT00633477|B1|Baseline|Resatorvid 2.4 mg/kg/Day|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
394003|NCT00633477|P2|Participant Flow|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394004|NCT00633477|P1|Participant Flow|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394005|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394006|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394007|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394008|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394009|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394010|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394011|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394012|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394013|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394014|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394015|NCT00633477|E2|Reported Event|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
394016|NCT00633477|E1|Reported Event|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
394017|NCT00633464|B3|Baseline|Total|Total of all reporting groups
394018|NCT00633464|B2|Baseline|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394019|NCT00633464|B1|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394020|NCT00633464|P2|Participant Flow|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394021|NCT00633464|P1|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394022|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394023|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394024|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394025|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394026|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394027|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394028|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394029|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394030|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394031|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
396793|NCT00630058|B3|Baseline|Total|Total of all reporting groups
394032|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394033|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394034|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394035|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394036|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394037|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394038|NCT00633464|E2|Reported Event|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
394039|NCT00633464|E1|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
394040|NCT00633399|B3|Baseline|Total|Total of all reporting groups
394041|NCT00633399|B2|Baseline|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394042|NCT00633399|B1|Baseline|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394043|NCT00633399|P2|Participant Flow|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394044|NCT00633399|P1|Participant Flow|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394045|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394046|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394047|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394048|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394049|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394050|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394051|NCT00633399|E2|Reported Event|Ziprasidone + Placebo|"Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
394052|NCT00633399|E1|Reported Event|Ziprasidone + Escitalpram|"Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
394053|NCT00636220|B1|Baseline|Confirmed HIV Infection|participants with known (clinically or serologically) confirmed HIV infection.
394054|NCT00636220|P1|Participant Flow|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
394055|NCT00636220|O1|Outcome|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
394056|NCT00636220|E1|Reported Event|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
394057|NCT00636207|B4|Baseline|Total|Total of all reporting groups
394058|NCT00636207|B3|Baseline|Part III|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
394059|NCT00636207|B2|Baseline|Part II|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
394060|NCT00636207|B1|Baseline|Part I|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
394061|NCT00636207|P7|Participant Flow|Part III - Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
394062|NCT00636207|P6|Participant Flow|Part III - Montelukast and Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
394115|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394116|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
394063|NCT00636207|P5|Participant Flow|Part III - Montelukast|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
394064|NCT00636207|P4|Participant Flow|Part II - Placebo|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
394065|NCT00636207|P3|Participant Flow|Part II - Montelukast|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
394066|NCT00636207|P2|Participant Flow|Part I - Montelukast and Placebo|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
394067|NCT00636207|P1|Participant Flow|Part I - Montelukast|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
394068|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394069|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394070|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394071|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394072|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394073|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394074|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394075|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394076|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394077|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394078|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394079|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394080|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
394081|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394082|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394083|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394084|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394085|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394086|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394087|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394088|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394089|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
394090|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394091|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394092|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394093|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394094|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394095|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394096|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394097|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394098|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
394099|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394100|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394101|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
394102|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
394103|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
394104|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394105|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394106|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394107|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
394108|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394109|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394110|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
394111|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394112|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394113|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394114|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394117|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394118|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394119|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394120|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394121|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394122|NCT00636207|E6|Reported Event|Placebo|Participants receiving Placebo inhalation powder
394123|NCT00636207|E5|Reported Event|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
394124|NCT00636207|E4|Reported Event|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
394125|NCT00636207|E3|Reported Event|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
394126|NCT00636207|E2|Reported Event|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
394127|NCT00636207|E1|Reported Event|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
394128|NCT00636194|B3|Baseline|Total|Total of all reporting groups
394129|NCT00636194|B2|Baseline|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394130|NCT00636194|B1|Baseline|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394131|NCT00636194|P2|Participant Flow|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394132|NCT00636194|P1|Participant Flow|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394133|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394134|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394135|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394136|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394137|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394138|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394139|NCT00636194|E2|Reported Event|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
394140|NCT00636194|E1|Reported Event|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
394141|NCT00636168|B3|Baseline|Total|Total of all reporting groups
394142|NCT00636168|B2|Baseline|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394143|NCT00636168|B1|Baseline|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394144|NCT00636168|P2|Participant Flow|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394145|NCT00636168|P1|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394146|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394147|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394209|NCT00635882|P3|Participant Flow|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394210|NCT00635882|P2|Participant Flow|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394213|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394148|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394149|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394150|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394151|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394152|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394153|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394154|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394155|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394156|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394157|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394158|NCT00636168|E2|Reported Event|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394211|NCT00635882|P1|Participant Flow|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394159|NCT00636168|E1|Reported Event|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
394160|NCT00636155|B1|Baseline|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
394161|NCT00636155|P1|Participant Flow|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
394162|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
394163|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
394164|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
394165|NCT00636155|E1|Reported Event|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
394166|NCT00636077|B1|Baseline|All Study Participants|
394167|NCT00636077|P4|Participant Flow|Optiflux F200NR First|Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
394168|NCT00636077|P3|Participant Flow|Optiflux F160NR First|Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
394169|NCT00636077|P2|Participant Flow|HD-C4 Small First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
394170|NCT00636077|P1|Participant Flow|HD-C4 Big First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
394171|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394172|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394173|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394174|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394175|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394176|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394177|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394178|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394179|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394180|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394181|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394182|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394183|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394184|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394185|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394186|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394187|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394188|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394189|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394190|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394191|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
394192|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
394193|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394194|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394195|NCT00636077|E4|Reported Event|F200NR|3 consecutive treatments with the F200NR dialyzer.
394196|NCT00636077|E3|Reported Event|F160NR|3 consecutive treatments with the F160NR dialyzer.
394197|NCT00636077|E2|Reported Event|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
394198|NCT00636077|E1|Reported Event|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
394199|NCT00635882|B7|Baseline|Total|Total of all reporting groups
394200|NCT00635882|B6|Baseline|Placebo|Placebo MDI BID for 14 days
394201|NCT00635882|B5|Baseline|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394202|NCT00635882|B4|Baseline|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394203|NCT00635882|B3|Baseline|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394204|NCT00635882|B2|Baseline|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394205|NCT00635882|B1|Baseline|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394206|NCT00635882|P6|Participant Flow|Placebo|Placebo MDI BID for 14 days
394207|NCT00635882|P5|Participant Flow|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394208|NCT00635882|P4|Participant Flow|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394214|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394215|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394216|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394217|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394218|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394219|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394220|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394221|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394222|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394223|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394224|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394225|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394226|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394227|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394228|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394229|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394230|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394231|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394232|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394233|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394234|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394235|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394236|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394237|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394238|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394239|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394240|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394241|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394242|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394243|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394244|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394245|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394246|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394247|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394248|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394249|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394250|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394251|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394252|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394253|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394254|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394255|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394256|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394257|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394258|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394259|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394260|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
394261|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
394262|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
394263|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
394264|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
394265|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
394266|NCT00635882|E6|Reported Event|PLACEBO|
394267|NCT00635882|E5|Reported Event|MF MDI 200 MCG BID|
394268|NCT00635882|E4|Reported Event|MF DPI 200 MCG BID|
394269|NCT00635882|E3|Reported Event|MF/F MDI 400/10 MCG BID|
394270|NCT00635882|E2|Reported Event|MF/F MDI 200/10 MCG BID|
394271|NCT00635882|E1|Reported Event|MF/F MDI 100/10 MCG BID|
394272|NCT00635830|B3|Baseline|Total|Total of all reporting groups
394273|NCT00635830|B2|Baseline|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394274|NCT00635830|B1|Baseline|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394321|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394275|NCT00635830|P2|Participant Flow|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394276|NCT00635830|P1|Participant Flow|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394277|NCT00635830|O2|Outcome|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394278|NCT00635830|O1|Outcome|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394279|NCT00635830|E2|Reported Event|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394280|NCT00635830|E1|Reported Event|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
394281|NCT00635817|B5|Baseline|Total|Total of all reporting groups
394282|NCT00635817|B4|Baseline|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394283|NCT00635817|B3|Baseline|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394284|NCT00635817|B2|Baseline|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394285|NCT00635817|B1|Baseline|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394286|NCT00635817|P4|Participant Flow|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394287|NCT00635817|P3|Participant Flow|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394288|NCT00635817|P2|Participant Flow|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394289|NCT00635817|P1|Participant Flow|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394290|NCT00635817|O2|Outcome|Leuprolide Acetate 30 mg|All subjects from both treatment groups who received 30 mg leuprolide acetate, both treatment naive and previously treated, were combined.
394291|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg|All subjects from both treatment groups who received 11.25 mg leuprolide acetate, both treatment naive and previously treated, were combined.
394292|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394293|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394294|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394295|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394296|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394297|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394298|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394299|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394300|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394301|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394302|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394303|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394304|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394305|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394306|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394307|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394308|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394309|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394310|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394311|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394312|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394313|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394314|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394315|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394316|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394317|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394318|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394319|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394320|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394322|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394323|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394324|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394325|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394326|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394327|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394328|NCT00635817|E4|Reported Event|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394329|NCT00635817|E3|Reported Event|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394330|NCT00635817|E2|Reported Event|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
394331|NCT00635817|E1|Reported Event|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
394332|NCT00635804|B9|Baseline|Total|Total of all reporting groups
394333|NCT00635804|B8|Baseline|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394334|NCT00635804|B7|Baseline|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394335|NCT00635804|B6|Baseline|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394336|NCT00635804|B5|Baseline|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394337|NCT00635804|B4|Baseline|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394338|NCT00635804|B3|Baseline|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394339|NCT00635804|B2|Baseline|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394340|NCT00635804|B1|Baseline|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394341|NCT00635804|P8|Participant Flow|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394342|NCT00635804|P7|Participant Flow|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394343|NCT00635804|P6|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394344|NCT00635804|P5|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394345|NCT00635804|P4|Participant Flow|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394346|NCT00635804|P3|Participant Flow|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394347|NCT00635804|P2|Participant Flow|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394348|NCT00635804|P1|Participant Flow|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394349|NCT00635804|O7|Outcome|Placebo|HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
394350|NCT00635804|O6|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394351|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panels E+F)|GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394485|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
394486|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
394352|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394353|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394354|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394355|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394356|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394357|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394358|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394359|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394360|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394361|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394362|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394363|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394364|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394365|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394366|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394367|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394368|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394369|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394370|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394371|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394372|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394373|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394374|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394375|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394487|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
396999|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
394376|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394377|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394378|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394379|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394380|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394381|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394382|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394383|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394384|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394385|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394386|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394387|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394388|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394389|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394390|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394391|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394392|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394393|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394394|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394395|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394396|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394397|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394398|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394399|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394488|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
397000|NCT00628862|O3|Outcome|Placebo|Placebo
394400|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394401|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394402|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394403|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394404|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394405|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394406|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394407|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394408|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394409|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394410|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394411|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394412|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394413|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394414|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394415|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394416|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394417|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394418|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394419|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394420|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394421|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394422|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394423|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394489|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
397001|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
394424|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394425|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394426|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394427|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394428|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394429|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394430|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394431|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394432|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394433|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394434|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394435|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394436|NCT00635804|E8|Reported Event|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
394437|NCT00635804|E7|Reported Event|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
394438|NCT00635804|E6|Reported Event|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394439|NCT00635804|E5|Reported Event|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
394440|NCT00635804|E4|Reported Event|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
394441|NCT00635804|E3|Reported Event|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
394442|NCT00635804|E2|Reported Event|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
394443|NCT00635804|E1|Reported Event|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
394444|NCT00635700|B3|Baseline|Total|Total of all reporting groups
394445|NCT00635700|B2|Baseline|Placebo|placebo: placebo
394446|NCT00635700|B1|Baseline|Ziprasidone|ziprasidone: 20-160 mg/d
394447|NCT00635700|P2|Participant Flow|Placebo|placebo: placebo
394448|NCT00635700|P1|Participant Flow|Ziprasidone|ziprasidone: 20-160 mg/d
394449|NCT00635700|O2|Outcome|Placebo|placebo: placebo
394450|NCT00635700|O1|Outcome|Ziprasidone|ziprasidone: 20-160 mg/d
394451|NCT00635700|E2|Reported Event|Placebo|placebo: placebo
394452|NCT00635700|E1|Reported Event|Ziprasidone|ziprasidone: 20-160 mg/d
394453|NCT00635661|B1|Baseline|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
394454|NCT00635661|P1|Participant Flow|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
394490|NCT00635570|E2|Reported Event|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
394455|NCT00635661|O1|Outcome|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
394456|NCT00635661|E1|Reported Event|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
394457|NCT00635648|B1|Baseline|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394458|NCT00635648|P1|Participant Flow|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394459|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394460|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394461|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394462|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394463|NCT00635648|E1|Reported Event|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
394464|NCT00635609|B3|Baseline|Total|Total of all reporting groups
394465|NCT00635609|B2|Baseline|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394466|NCT00635609|B1|Baseline|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394467|NCT00635609|P2|Participant Flow|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394468|NCT00635609|P1|Participant Flow|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394469|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394470|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394471|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394472|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394473|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394474|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394475|NCT00635609|E2|Reported Event|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
394476|NCT00635609|E1|Reported Event|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
394477|NCT00635570|B3|Baseline|Total|Total of all reporting groups
394478|NCT00635570|B2|Baseline|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
394479|NCT00635570|B1|Baseline|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
394480|NCT00635570|P2|Participant Flow|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
394481|NCT00635570|P1|Participant Flow|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
394482|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
394483|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
394484|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
397002|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
394491|NCT00635570|E1|Reported Event|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
394492|NCT00635492|B3|Baseline|Total|Total of all reporting groups
394493|NCT00635492|B2|Baseline|Insulin|Insulin at a dose selected by the HCP and patient
394494|NCT00635492|B1|Baseline|Exenatide BID|Daily dose ranging from 5-20 ug
394495|NCT00635492|P2|Participant Flow|Insulin|Insulin at a dose selected by the health care provided (HCP) and patient
394496|NCT00635492|P1|Participant Flow|Exenatide BID|Daily dose ranging from 5-20 mcg
394497|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394498|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394499|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394500|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394501|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394502|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394503|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394504|NCT00635492|O1|Outcome|Insulin Cohort|insulin at a dose selected by the HCP and patient
394505|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394506|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394507|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394508|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394509|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394510|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394511|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394512|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394513|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394514|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394515|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394516|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394517|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394518|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
394519|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394520|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394521|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394522|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394523|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394524|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394525|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394526|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394527|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394528|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394529|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394530|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394531|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394532|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394533|NCT00635492|O2|Outcome|Insulin|Insulin at a dose selected by the HCP and patient
394534|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20mcg/day
394535|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
394536|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
394537|NCT00635492|E2|Reported Event|Insulin|Insulin at a dose selected by the HCP and patient
394538|NCT00635492|E1|Reported Event|Exenatide BID|Daily dose ranging from 5-20 ug
394539|NCT00635479|B3|Baseline|Total|Total of all reporting groups
394540|NCT00635479|B2|Baseline|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
394541|NCT00635479|B1|Baseline|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
394542|NCT00635479|P2|Participant Flow|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
394543|NCT00635479|P1|Participant Flow|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
394544|NCT00635479|O2|Outcome|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
394545|NCT00635479|O1|Outcome|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
394546|NCT00635479|E2|Reported Event|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
394547|NCT00635479|E1|Reported Event|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
394548|NCT00635427|B6|Baseline|Total|Total of all reporting groups
394549|NCT00635427|B5|Baseline|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394550|NCT00635427|B4|Baseline|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039|Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
394551|NCT00635427|B3|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).
394552|NCT00635427|B2|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).
394553|NCT00635427|B1|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032)|VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.
394554|NCT00635427|P5|Participant Flow|VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
394555|NCT00635427|P4|Participant Flow|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044
394556|NCT00635427|P3|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
394557|NCT00635427|P2|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)
394558|NCT00635427|P1|Participant Flow|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032)|VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044
394559|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394560|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
394561|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394562|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394563|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
394564|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394565|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394566|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
394567|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394568|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394569|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
394570|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394571|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394572|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
394573|NCT00635427|O1|Outcome|VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039)|"This is the overall velaglucerase alfa group consisting of the following population:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394574|NCT00635427|E3|Reported Event|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
394575|NCT00635427|E2|Reported Event|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
394576|NCT00635427|E1|Reported Event|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
394577|NCT00635362|B3|Baseline|Total|Total of all reporting groups
394578|NCT00635362|B2|Baseline|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394901|NCT00634569|O2|Outcome|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
394902|NCT00634569|O1|Outcome|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
394579|NCT00635362|B1|Baseline|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394580|NCT00635362|P2|Participant Flow|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394581|NCT00635362|P1|Participant Flow|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394582|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394583|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394584|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394585|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394586|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394587|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394588|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394589|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394590|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394591|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394592|NCT00635362|E2|Reported Event|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
394593|NCT00635362|E1|Reported Event|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
394594|NCT00635349|B3|Baseline|Total|Total of all reporting groups
394595|NCT00635349|B2|Baseline|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394596|NCT00635349|B1|Baseline|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394635|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394597|NCT00635349|P2|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394598|NCT00635349|P1|Participant Flow|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394599|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394600|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394601|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394602|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394603|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394604|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394605|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394606|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394607|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394608|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394609|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394903|NCT00634569|E1|Reported Event|All Subjects|Intent-to-treat population
394904|NCT00634543|B3|Baseline|Total|Total of all reporting groups
397003|NCT00628862|O3|Outcome|Placebo|Placebo
394610|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394611|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394612|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394613|NCT00635349|E2|Reported Event|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
394614|NCT00635349|E1|Reported Event|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
394615|NCT00635154|B1|Baseline|Anakinra With/Without Dexamethasone|
394616|NCT00635154|P1|Participant Flow|Anakinra With/Without Dexamethasone|
394617|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
394618|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
394619|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
394620|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
394621|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
394622|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
394623|NCT00635154|O1|Outcome|Anakinra Without Dexamethasone|Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
394624|NCT00635154|E1|Reported Event|Anakinra With/Without Dexamethasone|
394625|NCT00635102|B3|Baseline|Total|Total of all reporting groups
394626|NCT00635102|B2|Baseline|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394627|NCT00635102|B1|Baseline|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394628|NCT00635102|P2|Participant Flow|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID).
394629|NCT00635102|P1|Participant Flow|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview
394630|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394631|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394632|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394633|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394634|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394636|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394637|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394638|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394639|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394640|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394641|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394642|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394643|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394644|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394645|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394646|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394647|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394648|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394649|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394650|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394651|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394652|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394653|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394654|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394655|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394656|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
395245|NCT00633893|B2|Baseline|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
394657|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394658|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394659|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394660|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394661|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394662|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394663|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394664|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394665|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394666|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394667|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394668|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394669|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394670|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394671|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394672|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394673|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394674|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394675|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394676|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394677|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
395246|NCT00633893|B1|Baseline|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
394678|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394679|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394680|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394681|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394682|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394683|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394684|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394685|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394686|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394687|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394688|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394689|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394690|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394691|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394692|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394693|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394694|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394695|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394696|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394697|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394698|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
395247|NCT00633893|P3|Participant Flow|Placebo|Participants received matching placebo oral tablet BID.
394699|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394700|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394701|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394702|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394703|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394704|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394705|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394706|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394707|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394708|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394709|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394710|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394711|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394712|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394713|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394714|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394715|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394716|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394717|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394718|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
394719|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
394720|NCT00635102|E2|Reported Event|Healthy Subjects|
394721|NCT00635102|E1|Reported Event|Alcoholic Subjects|
394722|NCT00635050|B1|Baseline|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
394723|NCT00635050|P1|Participant Flow|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
394724|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
394725|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin:~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
394726|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
394727|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
394728|NCT00635050|E1|Reported Event|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
394729|NCT00635024|B1|Baseline|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394730|NCT00635024|P1|Participant Flow|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394731|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394732|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394733|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394734|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394735|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394736|NCT00635024|E1|Reported Event|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
394737|NCT00634933|B4|Baseline|Total|Total of all reporting groups
395248|NCT00633893|P2|Participant Flow|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395249|NCT00633893|P1|Participant Flow|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban twice a day (BID)
394738|NCT00634933|B3|Baseline|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394739|NCT00634933|B2|Baseline|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394740|NCT00634933|B1|Baseline|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394741|NCT00634933|P5|Participant Flow|Placebo/TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
394742|NCT00634933|P4|Participant Flow|Placebo/TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394743|NCT00634933|P3|Participant Flow|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394744|NCT00634933|P2|Participant Flow|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394745|NCT00634933|P1|Participant Flow|Placebo|Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
394746|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394804|NCT00634933|E6|Reported Event|Placebo/TRU-015 Single Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
395250|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395251|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
394747|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394748|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394749|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394750|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394751|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394752|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394753|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394754|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394877|NCT00634621|B1|Baseline|Hexvix|Use of the Hexvix drug.
394878|NCT00634621|P1|Participant Flow|Hexvix 2 mg/mL Infusion|Administrtation of 2 mg/mL Hexvix.
395252|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
394755|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394756|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394757|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394758|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394759|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394760|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394761|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394762|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394879|NCT00634621|O1|Outcome|Confirmed Bladder Cancer by Standard of Truth|Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.
394880|NCT00634621|O4|Outcome|Multiple Normalized Biopsy|Only Multiple Normalized Biopsy.
394881|NCT00634621|O3|Outcome|Blue-light Cystoscopy Only|Hexvix administered using only Blue-light Cystoscopy.
394763|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394764|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394765|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394766|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394767|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394768|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394769|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394770|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394882|NCT00634621|O2|Outcome|White-light Cystoscopy Only|Hexvix administered using only White-light Cystoscopy.
394883|NCT00634621|O1|Outcome|White-light and Blue-Light Cystoscopy Simultaneously|Hexvix administered using both White-light and Blue-Light Cystoscopy.
394884|NCT00634621|E1|Reported Event|Hexvix|Use of the Hexvix drug.
394771|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394772|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394773|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394774|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394775|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394776|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394777|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394778|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394885|NCT00634582|B1|Baseline|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
395253|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
394779|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394780|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394781|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394782|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394783|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394784|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394785|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394786|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394886|NCT00634582|P1|Participant Flow|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
394887|NCT00634582|O1|Outcome|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
394787|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394788|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394789|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394790|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394791|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394792|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394793|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394794|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394888|NCT00634582|E1|Reported Event|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
394889|NCT00634569|B3|Baseline|Total|Total of all reporting groups
394890|NCT00634569|B2|Baseline|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
394795|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394796|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394797|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394798|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394799|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394800|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394801|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394802|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
394803|NCT00634933|E7|Reported Event|Placebo/TRU-015 Induction Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
397004|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
394805|NCT00634933|E5|Reported Event|TRU-015 Induction Dose (Part B)|Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394806|NCT00634933|E4|Reported Event|TRU-015 Single Dose (Part B)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
394807|NCT00634933|E3|Reported Event|TRU-015 Induction Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.
394808|NCT00634933|E2|Reported Event|TRU-015 Single Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.
394809|NCT00634933|E1|Reported Event|Placebo (Part A)|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
394810|NCT00634920|B4|Baseline|Total|Total of all reporting groups
394811|NCT00634920|B3|Baseline|Not Randomized Patients|This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population
394812|NCT00634920|B2|Baseline|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394813|NCT00634920|B1|Baseline|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394814|NCT00634920|P3|Participant Flow|Pre-Randomized Patients|All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization).
394815|NCT00634920|P2|Participant Flow|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394816|NCT00634920|P1|Participant Flow|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394817|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394818|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394819|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394891|NCT00634569|B1|Baseline|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
394820|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394821|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394822|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394823|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394824|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394825|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394826|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394827|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394828|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394829|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394830|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394831|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394832|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394833|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394892|NCT00634569|P2|Participant Flow|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
394893|NCT00634569|P1|Participant Flow|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
394834|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394835|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394836|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394837|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394838|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394839|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394840|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394841|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394842|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394843|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394844|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394845|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394846|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394847|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394894|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
394895|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
394896|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
394848|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394849|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394850|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394851|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394852|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394853|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394854|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394855|NCT00634920|E2|Reported Event|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
394856|NCT00634920|E1|Reported Event|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
394857|NCT00634842|B3|Baseline|Total|Total of all reporting groups
394858|NCT00634842|B2|Baseline|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394859|NCT00634842|B1|Baseline|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394860|NCT00634842|P2|Participant Flow|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394861|NCT00634842|P1|Participant Flow|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394862|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394863|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394864|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394865|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394866|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394867|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394868|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394869|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394870|NCT00634842|E2|Reported Event|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
394871|NCT00634842|E1|Reported Event|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
394872|NCT00634647|B1|Baseline|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
394873|NCT00634647|P1|Participant Flow|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
394874|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
394875|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
394876|NCT00634647|E1|Reported Event|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
394905|NCT00634543|B2|Baseline|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394906|NCT00634543|B1|Baseline|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394907|NCT00634543|P2|Participant Flow|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394908|NCT00634543|P1|Participant Flow|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394909|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394910|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394911|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394912|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394913|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394914|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394915|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394916|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394917|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394918|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394919|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394920|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394959|NCT00633594|O1|Outcome|Phase II - Lenalidomide 10mg PO QD|Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
394921|NCT00634543|E2|Reported Event|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394922|NCT00634543|E1|Reported Event|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
394923|NCT00634504|B3|Baseline|Total|Total of all reporting groups
394924|NCT00634504|B2|Baseline|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
394925|NCT00634504|B1|Baseline|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
394926|NCT00634504|P2|Participant Flow|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
394927|NCT00634504|P1|Participant Flow|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
394928|NCT00634504|O2|Outcome|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
394929|NCT00634504|O1|Outcome|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
394930|NCT00634504|E2|Reported Event|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
394931|NCT00634504|E1|Reported Event|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
394932|NCT00633594|B4|Baseline|Total|Total of all reporting groups
394933|NCT00633594|B3|Baseline|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
394934|NCT00633594|B2|Baseline|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
394935|NCT00633594|B1|Baseline|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
394936|NCT00633594|P3|Participant Flow|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394937|NCT00633594|P2|Participant Flow|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394938|NCT00633594|P1|Participant Flow|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
394939|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
394940|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
394941|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394942|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
395254|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395255|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
394943|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
394944|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
394945|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394946|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
394947|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
394948|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
394949|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394950|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
394951|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
394952|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
394953|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394954|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
394955|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
394956|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
394957|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
394958|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
395256|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395257|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
394960|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
394961|NCT00633594|E3|Reported Event|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
394962|NCT00633594|E2|Reported Event|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
394963|NCT00633594|E1|Reported Event|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14.
394964|NCT00634322|B4|Baseline|Total|Total of all reporting groups
394965|NCT00634322|B3|Baseline|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
394966|NCT00634322|B2|Baseline|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
394967|NCT00634322|B1|Baseline|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
394968|NCT00634322|P3|Participant Flow|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
394969|NCT00634322|P2|Participant Flow|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
394970|NCT00634322|P1|Participant Flow|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
394971|NCT00634322|O3|Outcome|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
394972|NCT00634322|O2|Outcome|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
394973|NCT00634322|O1|Outcome|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
394974|NCT00634322|E3|Reported Event|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
394975|NCT00634322|E2|Reported Event|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
394976|NCT00634322|E1|Reported Event|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
394977|NCT00634270|B3|Baseline|Total|Total of all reporting groups
394978|NCT00634270|B2|Baseline|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394979|NCT00634270|B1|Baseline|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394980|NCT00634270|P2|Participant Flow|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394981|NCT00634270|P1|Participant Flow|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
395065|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
394982|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
394983|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394984|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394985|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394986|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394987|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394988|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394989|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
394990|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394991|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
394992|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
394993|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
394994|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
395258|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
394995|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
394996|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing."
394997|NCT00634270|O2|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
394998|NCT00634270|O1|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
394999|NCT00634270|O1|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
395000|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
395001|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
395002|NCT00634270|E2|Reported Event|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
395003|NCT00634270|E1|Reported Event|Stratum 1|"Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals."
395004|NCT00634244|B4|Baseline|Total|Total of all reporting groups
395005|NCT00634244|B3|Baseline|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
395006|NCT00634244|B2|Baseline|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
395007|NCT00634244|B1|Baseline|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
395008|NCT00634244|P3|Participant Flow|Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)|"Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV~sirolimus: Given PO~etoposide: Given IV"
395009|NCT00634244|P2|Participant Flow|Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)|"Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
395010|NCT00634244|P1|Participant Flow|Arm A (Carboplatin and Topotecan Hydrochloride)|"Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.~carboplatin: Given IV~topotecan hydrochloride: Given IV"
395011|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
395012|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
395013|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
395014|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
395015|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
395016|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
395017|NCT00634244|E3|Reported Event|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
395018|NCT00634244|E2|Reported Event|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
395019|NCT00634244|E1|Reported Event|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
395066|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395020|NCT00634179|B1|Baseline|Treatment (VR-CHOP Regimen)|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity."
395021|NCT00634179|P1|Participant Flow|Treatment (VR-CHOP Regimen)|"Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.~In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma."
395022|NCT00634179|O2|Outcome|Phase II: Maintenance|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8~Rituximab: Rituximab 375 mg/m²~Doxorubicin: Doxorubicin 50 mg/m²~Cyclophosphamide: Cyclophosphamide 750 mg/m²~Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1~Prednisone: Prednisone 100 mg/day given orally on"
395023|NCT00634179|O1|Outcome|Phase I: Induction|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
395024|NCT00634179|O1|Outcome|MTD of Bortezomib With Vincristine Capped at 1.5 mg|Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
395025|NCT00634179|E2|Reported Event|Phase II: Maintenance|In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
395026|NCT00634179|E1|Reported Event|Phase I: Induction|Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
395027|NCT00634166|B3|Baseline|Total|Total of all reporting groups
395028|NCT00634166|B2|Baseline|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395029|NCT00634166|B1|Baseline|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395030|NCT00634166|P2|Participant Flow|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395031|NCT00634166|P1|Participant Flow|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395032|NCT00634166|O2|Outcome|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395033|NCT00634166|O1|Outcome|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395085|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395259|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
397005|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
395034|NCT00634166|E2|Reported Event|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395035|NCT00634166|E1|Reported Event|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
395036|NCT00634114|B4|Baseline|Total|Total of all reporting groups
395037|NCT00634114|B3|Baseline|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395038|NCT00634114|B2|Baseline|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395039|NCT00634114|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395040|NCT00634114|P3|Participant Flow|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395041|NCT00634114|P2|Participant Flow|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395042|NCT00634114|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395043|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395044|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395045|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395046|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395047|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395048|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395049|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395050|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395051|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395052|NCT00634114|E3|Reported Event|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
395053|NCT00634114|E2|Reported Event|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
395054|NCT00634114|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
395055|NCT00634088|B5|Baseline|Total|Total of all reporting groups
395056|NCT00634088|B4|Baseline|Ixabepilone + Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
395057|NCT00634088|B3|Baseline|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg), lapatinib 1250 mg administered orally once a day, every day for 7 to 14 consecutive days prior to the first administration of ixabepilone in Cycle 1. Then lapatinib administered daily, orally once a day, for a 21-day cycle. Ixabepilone administered as a 3-hour IV infusion of 40 mg/m^2 following lapatinib lead-in period.
395058|NCT00634088|B2|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg), lapatinib 1250 mg administered orally once a day, every day, for 7 to 14 consecutive days prior to the first administration of ixabepilone. Then lapatinib administered orally once a day, every day, for a 21-day cycle. After lapatinib lead-in period, ixabepilone administered as a 3-hour IV infusion of 32 mg/m^2.
395059|NCT00634088|B1|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib administered daily in escalating cohorts, beginning with 1000 mg, orally once a day, for 7 to 14 consecutive days in Cycle 1 prior to the first administration of ixabepilone. Then lapatinib administered daily, orally once a day, for a 21-day cycle. After the lapatinib lead-in phase, ixabepilone administered as a 3-hour IV infusion in escalating doses, beginning with 32 mg/m^2.
395060|NCT00634088|P4|Participant Flow|Ixabepilone+ Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
395061|NCT00634088|P3|Participant Flow|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
395062|NCT00634088|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
395063|NCT00634088|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
395064|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395121|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
395260|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395261|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395067|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395068|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395069|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395070|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395071|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395072|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
395073|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395074|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395075|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395076|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395077|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395078|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395079|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395080|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395081|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395082|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395083|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395084|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395086|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395087|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395088|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395089|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395090|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395091|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395092|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395093|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395094|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395095|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395096|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395097|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395098|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395099|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395100|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395101|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395102|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395262|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395103|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395104|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395105|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
395106|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395107|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
395108|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
395109|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
395110|NCT00634088|E3|Reported Event|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
395111|NCT00634088|E2|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
395112|NCT00634088|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for 21-day cycle.
395113|NCT00634049|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
395114|NCT00634049|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
395115|NCT00634049|O1|Outcome|Isavuconazole|Participants received Isavuconazole intravenous (IV) or per oral (PO) over period of 2 days, on days 1 and 2 three doses of 200 mg were administered every 8 hours for a total of six doses. From Day 3 to End of Treatment (EOT) maintenance dose of 200 mg isavuconazole was administered once daily up to 180 days; with an option for extended treatment under specified criteria.
395116|NCT00634049|O2|Outcome|Not Renally Impaired|Not Renally Impaired (NRI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395117|NCT00634049|O1|Outcome|Renally Impaired|Renally Impaired (RI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. Renal impairment was defined as yes for participants who had a baseline eGFR-MDRD < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395118|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395119|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395120|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395263|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
397006|NCT00628862|O3|Outcome|Placebo|Placebo
395122|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395123|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395124|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
395125|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395126|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395127|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395128|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395129|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395130|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395131|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
395132|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395133|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395134|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
395135|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395136|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395170|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395264|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395137|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395138|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395139|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395140|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395141|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
395142|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395143|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395144|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
395145|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395146|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395147|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395148|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395149|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other Non Candida Yeast mITT population consisted of 11 participants who have had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus NOS and 2 Trichosporon).
395150|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who have had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes,9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395151|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
395152|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who have had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium,2 Exophiala,2 Cladosporium,2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia,Exserohilum, Paecilomyces,Pseudallescheria and Scedosporium).
395153|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales – Intolerant mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395171|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
395154|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales – Refractory Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
395155|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales – Primary Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395156|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Overall there were 24 participants in the mITTAspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395157|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395158|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395159|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395160|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395161|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
395162|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395163|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395164|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
395165|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395166|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395167|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395168|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395169|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395172|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395173|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
395174|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
395175|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395176|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395177|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired or not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395178|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
395179|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
395180|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
395181|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
395182|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
395183|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
395184|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
395185|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
395186|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
395241|NCT00633919|E2|Reported Event|Placebo|SLITone Placebo
395242|NCT00633919|E1|Reported Event|Active|SLITone Dermatophagoides Mix
395243|NCT00633893|B4|Baseline|Total|Total of all reporting groups
395244|NCT00633893|B3|Baseline|Placebo|Participants received matching placebo oral tablet BID.
395187|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
395188|NCT00634049|E2|Reported Event|Not Renally Impaired (NRI)|"Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD~≥ 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula."
395189|NCT00634049|E1|Reported Event|Renally Impaired (RI)|Renal impairment was defined as yes for participants who have a baseline as eGFR < 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula.
395190|NCT00634010|B3|Baseline|Total|Total of all reporting groups
395191|NCT00634010|B2|Baseline|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
395192|NCT00634010|B1|Baseline|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
395193|NCT00634010|P2|Participant Flow|Methadone Capsule|Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
395194|NCT00634010|P1|Participant Flow|Morphine Capsule|Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.
395195|NCT00634010|O2|Outcome|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
395196|NCT00634010|O1|Outcome|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
395197|NCT00634010|E2|Reported Event|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
395198|NCT00634010|E1|Reported Event|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
395199|NCT00633984|B3|Baseline|Total|Total of all reporting groups
395200|NCT00633984|B2|Baseline|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
395201|NCT00633984|B1|Baseline|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
395202|NCT00633984|P2|Participant Flow|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
395203|NCT00633984|P1|Participant Flow|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
395204|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
395205|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
395206|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
395207|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
395208|NCT00633984|E2|Reported Event|Cognitive Behavioral Therapy + Placebo|Participants received Cognitive Behavioral Group Therapy and Placebo.
395209|NCT00633984|E1|Reported Event|Cognitive Behavioral Therapy + DCS|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
395210|NCT00633932|B4|Baseline|Total|Total of all reporting groups
395211|NCT00633932|B3|Baseline|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
395212|NCT00633932|B2|Baseline|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
395213|NCT00633932|B1|Baseline|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
395214|NCT00633932|P3|Participant Flow|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
395215|NCT00633932|P2|Participant Flow|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
395216|NCT00633932|P1|Participant Flow|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
395217|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
395218|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
395219|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
395220|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
395221|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
395222|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
395223|NCT00633932|E3|Reported Event|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
395224|NCT00633932|E2|Reported Event|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
395225|NCT00633932|E1|Reported Event|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
395226|NCT00633919|B3|Baseline|Total|Total of all reporting groups
395227|NCT00633919|B2|Baseline|Placebo|SLITone Placebo
395228|NCT00633919|B1|Baseline|Active|SLITone Dermatophagoides Mix
395229|NCT00633919|P2|Participant Flow|Placebo|SLITone Placebo
395230|NCT00633919|P1|Participant Flow|Active|SLITone Dermatophagoides Mix
395231|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
395232|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
395233|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
395234|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
395235|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
395236|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
395237|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
395238|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
395239|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
395240|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
395265|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395266|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395267|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395268|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395269|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395270|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395271|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395272|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395273|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395274|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395275|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395276|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395277|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395278|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395279|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395280|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395281|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395282|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395283|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395284|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395285|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395286|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395287|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395288|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395289|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395290|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395291|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395292|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395293|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395294|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395295|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395296|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395297|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395298|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395299|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395300|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395301|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395302|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395303|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395304|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395305|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395306|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395307|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395308|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395309|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395310|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395311|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395312|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395313|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
395314|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
395315|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
395316|NCT00633893|E3|Reported Event|Placebo|Participants received oral tablet of placebo BID
395317|NCT00633893|E2|Reported Event|Apixaban 5mg|Participants received 5 mg oral tablet apixaban BID
395318|NCT00633893|E1|Reported Event|Apixaban 2.5mg|Participants received 2.5 mg oral tablet apixaban BID
395319|NCT00633880|B4|Baseline|Total|Total of all reporting groups
395320|NCT00633880|B3|Baseline|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395321|NCT00633880|B2|Baseline|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395322|NCT00633880|B1|Baseline|Not Randomized|Entered open-label droxidopa dose titration, but did not randomize
395323|NCT00633880|P3|Participant Flow|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395353|NCT00633867|B1|Baseline|McGrath|Tracheal Intubation using McGrath video-laryngoscope
395324|NCT00633880|P2|Participant Flow|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395325|NCT00633880|P1|Participant Flow|Open Label Titration|All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
395326|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395327|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395328|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395329|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395330|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395331|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395332|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395333|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395334|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395335|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395336|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395337|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395338|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395339|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395340|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395341|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395342|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395343|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395344|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395345|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395346|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395347|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395348|NCT00633880|E3|Reported Event|Open Label Phase|All patient titrated on droxidopa during open-label phase
395349|NCT00633880|E2|Reported Event|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395350|NCT00633880|E1|Reported Event|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
395351|NCT00633867|B3|Baseline|Total|Total of all reporting groups
395352|NCT00633867|B2|Baseline|Macintosh|Tracheal intubation using Macintosh Laryngoscope
397007|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
395354|NCT00633867|P2|Participant Flow|Macintosh|Tracheal intubation using Macintosh Laryngoscope
395355|NCT00633867|P1|Participant Flow|McGrath|Tracheal Intubation using McGrath video-laryngoscope
395356|NCT00633867|O2|Outcome|Macintosh|Tracheal intubation using Macintosh Laryngoscope
395357|NCT00633867|O1|Outcome|McGrath|Tracheal Intubation using McGrath video-laryngoscope
395358|NCT00633867|E2|Reported Event|Macintosh|Tracheal intubation using Macintosh Laryngoscope
395359|NCT00633867|E1|Reported Event|McGrath|Tracheal Intubation using McGrath video-laryngoscope
395360|NCT00633750|B1|Baseline|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
395361|NCT00633750|P1|Participant Flow|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
395362|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.
395363|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
395364|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
395365|NCT00633750|E1|Reported Event|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
395366|NCT00633256|B3|Baseline|Total|Total of all reporting groups
395367|NCT00633256|B2|Baseline|Placebo|Matched placebo
395368|NCT00633256|B1|Baseline|Cycloserine|50 mg cycloserine
395369|NCT00633256|P2|Participant Flow|Placebo|Matched placebo
395370|NCT00633256|P1|Participant Flow|Cycloserine|50 mg cycloserine
395371|NCT00633256|O2|Outcome|Placebo|Matched placebo
395372|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
395373|NCT00633256|O2|Outcome|Placebo|Matched placebo
395374|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
395375|NCT00633256|O2|Outcome|Placebo|Matched placebo
395376|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
395377|NCT00633256|E2|Reported Event|Placebo|Matched placebo
395378|NCT00633256|E1|Reported Event|Cycloserine|50 mg cycloserine
395379|NCT00633243|B3|Baseline|Total|Total of all reporting groups
395380|NCT00633243|B2|Baseline|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
395381|NCT00633243|B1|Baseline|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
395382|NCT00633243|P2|Participant Flow|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
395383|NCT00633243|P1|Participant Flow|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
395384|NCT00633243|O2|Outcome|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
395385|NCT00633243|O1|Outcome|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
395386|NCT00633243|E2|Reported Event|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
395387|NCT00633243|E1|Reported Event|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
395388|NCT00633217|B3|Baseline|Total|Total of all reporting groups
395389|NCT00633217|B2|Baseline|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395390|NCT00633217|B1|Baseline|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395391|NCT00633217|P2|Participant Flow|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395392|NCT00633217|P1|Participant Flow|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395393|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395394|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395395|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395396|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395397|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395398|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395399|NCT00633217|E2|Reported Event|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
395400|NCT00633217|E1|Reported Event|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
395401|NCT00633152|B3|Baseline|Total|Total of all reporting groups
395402|NCT00633152|B2|Baseline|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
395403|NCT00633152|B1|Baseline|Ceftaroline|Intramuscular every 12 hours
395404|NCT00633152|P2|Participant Flow|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
395405|NCT00633152|P1|Participant Flow|Ceftaroline|Intramuscular every 12 hours
395406|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg IV infusions over 60 minutes q12h
395407|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline fosamil was administered 600mg IM every 12 hours
395408|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
395409|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours
395410|NCT00633152|E2|Reported Event|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
395411|NCT00633152|E1|Reported Event|Ceftaroline|Intramuscular every 12 hours
395412|NCT00633139|B4|Baseline|Total|Total of all reporting groups
395413|NCT00633139|B3|Baseline|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395414|NCT00633139|B2|Baseline|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395415|NCT00633139|B1|Baseline|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395416|NCT00633139|P3|Participant Flow|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395417|NCT00633139|P2|Participant Flow|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395418|NCT00633139|P1|Participant Flow|Cohort 1|Participants received a single dose of rhASA at 25 units per kilogram (U/kg) intravenous (IV) infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395419|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395420|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395421|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395422|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395423|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395424|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395425|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395426|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395427|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395428|NCT00633139|E3|Reported Event|Cohort 3|Cohort 3: Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
395429|NCT00633139|E2|Reported Event|Cohort 2|Cohort 2: Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
395430|NCT00633139|E1|Reported Event|Cohort 1|Cohort 1: Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
395431|NCT00633126|B1|Baseline|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
395432|NCT00633126|P1|Participant Flow|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
395433|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
395434|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
395435|NCT00633126|E1|Reported Event|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
395436|NCT00633087|B1|Baseline|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395437|NCT00633087|P1|Participant Flow|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395438|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395439|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395440|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395441|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395442|NCT00633087|E1|Reported Event|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
395443|NCT00633074|B3|Baseline|Total|Total of all reporting groups
395444|NCT00633074|B2|Baseline|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395445|NCT00633074|B1|Baseline|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395446|NCT00633074|P2|Participant Flow|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395447|NCT00633074|P1|Participant Flow|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395448|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395449|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395450|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395451|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395452|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395453|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395454|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395455|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395456|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395457|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395458|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395459|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395460|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395461|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395462|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395463|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395464|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395465|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395466|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395467|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395468|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395469|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395470|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395471|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395472|NCT00633074|E2|Reported Event|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
395473|NCT00633074|E1|Reported Event|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
395474|NCT00633009|B4|Baseline|Total|Total of all reporting groups
395475|NCT00633009|B3|Baseline|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395476|NCT00633009|B2|Baseline|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395477|NCT00633009|B1|Baseline|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395478|NCT00633009|P3|Participant Flow|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
395479|NCT00633009|P2|Participant Flow|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
395480|NCT00633009|P1|Participant Flow|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
395481|NCT00633009|O3|Outcome|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395482|NCT00633009|O2|Outcome|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395483|NCT00633009|O1|Outcome|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
395484|NCT00633009|O3|Outcome|50 ug Study Group|
395485|NCT00633009|O2|Outcome|30 ug Study Group|
395486|NCT00633009|O1|Outcome|15 ug Study Group|
395487|NCT00633009|E3|Reported Event|50 ug Study Group|
395488|NCT00633009|E2|Reported Event|30 ug Study Group|
395489|NCT00633009|E1|Reported Event|15 ug Study Group|
395490|NCT00632931|B1|Baseline|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
395491|NCT00632931|P3|Participant Flow|All Participants: Part 2|"Vorinostat 400 mg once daily.~Ten participants changed dosage to vorinostat 300 mg daily during Part 2."
395492|NCT00632931|P2|Participant Flow|Placebo Then Vorinostat: Part 1|Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
395493|NCT00632931|P1|Participant Flow|Vorinostat Then Placebo: Part 1|Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
395494|NCT00632931|O2|Outcome|Placebo|
395495|NCT00632931|O1|Outcome|Vorinostat|
395496|NCT00632931|O2|Outcome|Placebo|
395497|NCT00632931|O1|Outcome|Vorinostat|
395498|NCT00632931|O2|Outcome|Placebo|
395499|NCT00632931|O1|Outcome|Vorinostat|
395500|NCT00632931|O2|Outcome|Placebo|
395501|NCT00632931|O1|Outcome|Vorinostat|
395502|NCT00632931|O2|Outcome|Placebo|
395503|NCT00632931|O1|Outcome|Vorinostat|
395504|NCT00632931|O2|Outcome|Placebo|
395505|NCT00632931|O1|Outcome|Vorinostat|
395506|NCT00632931|O2|Outcome|Placebo|
395507|NCT00632931|O1|Outcome|Vorinostat|
395508|NCT00632931|O2|Outcome|Placebo|
395509|NCT00632931|O1|Outcome|Vorinostat|
395510|NCT00632931|E1|Reported Event|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
395511|NCT00632814|B4|Baseline|Total|Total of all reporting groups
395512|NCT00632814|B3|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395513|NCT00632814|B2|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395514|NCT00632814|B1|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395515|NCT00632814|P3|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395516|NCT00632814|P2|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395517|NCT00632814|P1|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395518|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395519|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395520|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395521|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395522|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395523|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395524|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395525|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395526|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395527|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395528|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395529|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395530|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395531|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395532|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395533|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395534|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395535|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395536|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395537|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395538|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395539|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395540|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395541|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395542|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395543|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395544|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395545|NCT00632814|E3|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
395546|NCT00632814|E2|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
395547|NCT00632814|E1|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
395548|NCT00632749|B15|Baseline|Total|Total of all reporting groups
395549|NCT00632749|B14|Baseline|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395550|NCT00632749|B13|Baseline|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395551|NCT00632749|B12|Baseline|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395552|NCT00632749|B11|Baseline|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395553|NCT00632749|B10|Baseline|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395554|NCT00632749|B9|Baseline|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395555|NCT00632749|B8|Baseline|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395935|NCT00632502|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395936|NCT00632489|B4|Baseline|Total|Total of all reporting groups
395556|NCT00632749|B7|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395557|NCT00632749|B6|Baseline|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395558|NCT00632749|B5|Baseline|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395559|NCT00632749|B4|Baseline|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395560|NCT00632749|B3|Baseline|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395561|NCT00632749|B2|Baseline|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395562|NCT00632749|B1|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395563|NCT00632749|P14|Participant Flow|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395564|NCT00632749|P13|Participant Flow|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395565|NCT00632749|P12|Participant Flow|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395566|NCT00632749|P11|Participant Flow|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395567|NCT00632749|P10|Participant Flow|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395568|NCT00632749|P9|Participant Flow|80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395569|NCT00632749|P8|Participant Flow|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395570|NCT00632749|P7|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395571|NCT00632749|P6|Participant Flow|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395572|NCT00632749|P5|Participant Flow|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395883|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
396185|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
395573|NCT00632749|P4|Participant Flow|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395574|NCT00632749|P3|Participant Flow|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395575|NCT00632749|P2|Participant Flow|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395576|NCT00632749|P1|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395577|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395578|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395579|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395580|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395581|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395582|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395583|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395584|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395585|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395586|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395587|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395588|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395589|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395590|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395591|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395592|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395593|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395594|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395595|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395596|NCT00632749|O9|Outcome|80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395597|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395598|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395599|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395600|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395601|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395602|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395603|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395604|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395605|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395606|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395607|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395608|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395609|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395610|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395611|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395612|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395613|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395614|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395615|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395616|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395617|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395618|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395619|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395620|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395621|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395622|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395623|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395624|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395625|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395626|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395627|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395628|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395629|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395630|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395631|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395632|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395633|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395634|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395635|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395636|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395637|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395638|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395639|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395640|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395641|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395642|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395643|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395644|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395645|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395646|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395647|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395648|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395649|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395650|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395651|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395652|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395653|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395654|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395655|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395656|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395657|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395658|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395659|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395660|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395661|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395662|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395663|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395664|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395665|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395666|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395667|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395668|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395669|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395670|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395671|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395672|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395673|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395674|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395675|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395676|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395677|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395678|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395679|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395680|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395681|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395682|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395683|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395684|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395685|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395686|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395687|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395688|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395689|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395690|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395691|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395692|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395693|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395694|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395695|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395696|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395697|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395698|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395699|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395700|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395701|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395702|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395703|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395704|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395705|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395706|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395707|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395708|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395709|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395710|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395711|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395712|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395713|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395714|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395715|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395716|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395717|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395718|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395719|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395720|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395721|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395722|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395723|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395724|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395725|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395726|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395727|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395728|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395729|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395730|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395731|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395732|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395733|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395734|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395735|NCT00632749|O6|Outcome|120mg (BI 811283+ Cytarabine)- Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395736|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395737|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395738|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine- Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395739|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395740|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395741|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395742|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395743|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395744|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395745|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395746|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395747|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395748|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395749|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395750|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395751|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395752|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395753|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395754|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395755|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395756|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395757|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395758|NCT00632749|O11|Outcome|240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395759|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395760|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395761|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395762|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395763|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395764|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395765|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395766|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395767|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395768|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395769|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395770|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395771|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395772|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395773|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395774|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395775|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395776|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395777|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395778|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395779|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395780|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395781|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395782|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395783|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395784|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395785|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395786|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395787|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395788|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395789|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395790|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395791|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395792|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395793|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395794|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395795|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395796|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395797|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395798|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395799|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395800|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395801|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395802|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395803|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395804|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395805|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395806|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395807|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395808|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395809|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395810|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395811|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395812|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395813|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395814|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395815|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395816|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395817|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395818|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395819|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395820|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395821|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395822|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395823|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395824|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395825|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395826|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395827|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395828|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395829|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395830|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395831|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395832|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395833|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395834|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395835|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395836|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395837|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395838|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395839|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395840|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395841|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395842|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395843|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395844|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395845|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395846|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395847|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395848|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395849|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395850|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395851|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395852|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395853|NCT00632749|O2|Outcome|Treatment Schedule B|"Subjects received BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 40, 80, 160, 240, 300, 360 and 420 mg being used in Schedule B.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395854|NCT00632749|O1|Outcome|Treatment Schedule A|"Subjects received BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 15, 30, 60, 100 and 120 mg used in Schedule A.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395855|NCT00632749|E14|Reported Event|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395856|NCT00632749|E13|Reported Event|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395857|NCT00632749|E12|Reported Event|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395858|NCT00632749|E11|Reported Event|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395859|NCT00632749|E10|Reported Event|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395884|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395860|NCT00632749|E9|Reported Event|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395861|NCT00632749|E8|Reported Event|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395862|NCT00632749|E7|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395863|NCT00632749|E6|Reported Event|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395864|NCT00632749|E5|Reported Event|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395865|NCT00632749|E4|Reported Event|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395866|NCT00632749|E3|Reported Event|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395867|NCT00632749|E2|Reported Event|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395868|NCT00632749|E1|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
395869|NCT00632736|B1|Baseline|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
395870|NCT00632736|P1|Participant Flow|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
395871|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
395872|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
395873|NCT00632736|E1|Reported Event|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
395874|NCT00632632|B3|Baseline|Total|Total of all reporting groups
395875|NCT00632632|B2|Baseline|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
395876|NCT00632632|B1|Baseline|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395877|NCT00632632|P2|Participant Flow|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
395878|NCT00632632|P1|Participant Flow|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395879|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
395880|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395881|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
395882|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395931|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395885|NCT00632632|E2|Reported Event|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
395886|NCT00632632|E1|Reported Event|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
395887|NCT00632619|B3|Baseline|Total|Total of all reporting groups
395888|NCT00632619|B2|Baseline|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395889|NCT00632619|B1|Baseline|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395890|NCT00632619|P2|Participant Flow|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395891|NCT00632619|P1|Participant Flow|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395892|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395893|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395894|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395895|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395896|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395897|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395932|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395933|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395934|NCT00632502|E2|Reported Event|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395898|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395899|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395900|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395901|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395902|NCT00632619|E2|Reported Event|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
395903|NCT00632619|E1|Reported Event|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
395904|NCT00632541|B1|Baseline|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
395905|NCT00632541|P1|Participant Flow|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
395906|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
395907|NCT00632541|E1|Reported Event|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
395908|NCT00632502|B3|Baseline|Total|Total of all reporting groups
395909|NCT00632502|B2|Baseline|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395910|NCT00632502|B1|Baseline|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395911|NCT00632502|P2|Participant Flow|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395912|NCT00632502|P1|Participant Flow|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395913|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395914|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395915|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395916|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395917|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395918|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395919|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395920|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395921|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395922|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395923|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395924|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395925|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
395926|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395927|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
395928|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395929|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
395930|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
395937|NCT00632489|B3|Baseline|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395938|NCT00632489|B2|Baseline|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395939|NCT00632489|B1|Baseline|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
395940|NCT00632489|P3|Participant Flow|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395941|NCT00632489|P2|Participant Flow|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395942|NCT00632489|P1|Participant Flow|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
395943|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395944|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395945|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
395946|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395947|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395948|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
396061|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
395949|NCT00632489|E3|Reported Event|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395950|NCT00632489|E2|Reported Event|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
395951|NCT00632489|E1|Reported Event|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
395952|NCT00632463|B4|Baseline|Total|Total of all reporting groups
395953|NCT00632463|B3|Baseline|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395954|NCT00632463|B2|Baseline|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395955|NCT00632463|B1|Baseline|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395956|NCT00632463|P3|Participant Flow|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395957|NCT00632463|P2|Participant Flow|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395958|NCT00632463|P1|Participant Flow|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395959|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395960|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395961|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395962|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395963|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395964|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395965|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395966|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395967|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395968|NCT00632463|E3|Reported Event|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
395969|NCT00632463|E2|Reported Event|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395970|NCT00632463|E1|Reported Event|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
395971|NCT00632424|B4|Baseline|Total|Total of all reporting groups
395972|NCT00632424|B3|Baseline|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
395973|NCT00632424|B2|Baseline|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
395974|NCT00632424|B1|Baseline|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
395975|NCT00632424|P1|Participant Flow|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.
395976|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
395977|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
395978|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
395979|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
395980|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
395981|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
396062|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
395982|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
395983|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
395984|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
395985|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
395986|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
395987|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
395988|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
395989|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
395990|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
395991|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
395992|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
395993|NCT00632424|E3|Reported Event|Ixa 150 mg/Day|
395994|NCT00632424|E2|Reported Event|Ixa 120 mg/Day|
395995|NCT00632424|E1|Reported Event|Ixa 90 mg/Day|
395996|NCT00632281|B1|Baseline|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
395997|NCT00632281|P1|Participant Flow|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
395998|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
395999|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
396000|NCT00632281|E1|Reported Event|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
396001|NCT00632229|B3|Baseline|Total|Total of all reporting groups
396002|NCT00632229|B2|Baseline|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396003|NCT00632229|B1|Baseline|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396004|NCT00632229|P2|Participant Flow|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396005|NCT00632229|P1|Participant Flow|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396006|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396007|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396008|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396009|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396010|NCT00632229|E2|Reported Event|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396011|NCT00632229|E1|Reported Event|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
396012|NCT00632203|B3|Baseline|Total|Total of all reporting groups
396013|NCT00632203|B2|Baseline|Observation|Observation
396014|NCT00632203|B1|Baseline|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396015|NCT00632203|P2|Participant Flow|Observation|Observation
396016|NCT00632203|P1|Participant Flow|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396017|NCT00632203|O2|Outcome|Observation|Observation
396018|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396019|NCT00632203|O2|Outcome|Observation|Observation
396020|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396021|NCT00632203|O2|Outcome|Observation|Observation
396183|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396022|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396023|NCT00632203|O2|Outcome|Observation|Observation
396024|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396025|NCT00632203|O2|Outcome|Observation|Observation
396026|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396027|NCT00632203|O2|Outcome|Observation|Observation
396028|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396029|NCT00632203|O2|Outcome|Observation|Observation
396030|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396031|NCT00632203|E2|Reported Event|Observation|Observation
396032|NCT00632203|E1|Reported Event|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
396033|NCT00632099|B3|Baseline|Total|Total of all reporting groups
396034|NCT00632099|B2|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
396035|NCT00632099|B1|Baseline|Matched Placebo|"matched placebo~Placebo: matched placebo"
396036|NCT00632099|P2|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
396037|NCT00632099|P1|Participant Flow|Matched Placebo|"matched placebo~Placebo: matched placebo"
396038|NCT00632099|O2|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
396039|NCT00632099|O1|Outcome|Matched Placebo|"matched placebo~Placebo: matched placebo"
396040|NCT00632099|E2|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
396041|NCT00632099|E1|Reported Event|Matched Placebo|"matched placebo~Placebo: matched placebo"
396042|NCT00631969|B3|Baseline|Total|Total of all reporting groups
396043|NCT00631969|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396044|NCT00631969|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396045|NCT00631969|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396046|NCT00631969|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396047|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
396048|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
396049|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
396050|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
396051|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
396052|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
396053|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
396054|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
396055|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396056|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396057|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396058|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396059|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396060|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396063|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396064|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396065|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396066|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396067|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396068|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396069|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396070|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396071|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396072|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396073|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396074|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396075|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396076|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396077|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396078|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396079|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396080|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396081|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396082|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396083|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396084|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396085|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396086|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396087|NCT00631969|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396088|NCT00631969|E1|Reported Event|Vardenafil ODT (STAXYN, BAY 38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
396089|NCT00631917|B3|Baseline|Total|Total of all reporting groups
396090|NCT00631917|B2|Baseline|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396091|NCT00631917|B1|Baseline|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396092|NCT00631917|P2|Participant Flow|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396093|NCT00631917|P1|Participant Flow|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396094|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396095|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396184|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
396096|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396097|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396098|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396099|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396100|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396101|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396102|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396103|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396104|NCT00631917|E2|Reported Event|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
396105|NCT00631917|E1|Reported Event|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
396106|NCT00631748|B3|Baseline|Total|Total of all reporting groups
396107|NCT00631748|B2|Baseline|Placebo|Placebo (sugar pill)
396108|NCT00631748|B1|Baseline|Study Drug|Oral quetiapine
396109|NCT00631748|P2|Participant Flow|Placebo|Placebo (sugar pill)
396110|NCT00631748|P1|Participant Flow|Study Drug|Oral quetiapine
396111|NCT00631748|O2|Outcome|Placebo|match placebo (sugar pill)
396112|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
396113|NCT00631748|O2|Outcome|Placebo|matched placebo (sugar pill)
396114|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
396115|NCT00631748|E2|Reported Event|Placebo|Placebo (sugar pill)
396116|NCT00631748|E1|Reported Event|Study Drug|Oral quetiapine
396117|NCT00631696|B3|Baseline|Total|Total of all reporting groups
396118|NCT00631696|B2|Baseline|Placebo|Placebo matching pregabalin treatment.
396119|NCT00631696|B1|Baseline|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396120|NCT00631696|P2|Participant Flow|Placebo|Placebo matching pregabalin treatment.
396121|NCT00631696|P1|Participant Flow|Pregabalin|Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396122|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396123|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396124|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396125|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396126|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396127|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396128|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396129|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396130|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396131|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396132|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396133|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396134|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396135|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396136|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396137|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396138|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396139|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396140|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
396141|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396142|NCT00631696|E2|Reported Event|Placebo|Placebo matching pregabalin treatment.
396143|NCT00631696|E1|Reported Event|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
396144|NCT00631670|B3|Baseline|Total|Total of all reporting groups
396145|NCT00631670|B2|Baseline|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
396146|NCT00631670|B1|Baseline|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
396147|NCT00631670|P2|Participant Flow|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
396148|NCT00631670|P1|Participant Flow|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
396149|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
396150|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
396151|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
396152|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
396153|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
396154|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
396155|NCT00631670|O2|Outcome|25 Treatments Grouop|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
396156|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one treatment
396157|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
396158|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
396159|NCT00631670|E2|Reported Event|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
396160|NCT00631670|E1|Reported Event|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
396161|NCT00631657|B3|Baseline|Total|Total of all reporting groups
396162|NCT00631657|B2|Baseline|Placebo|Participants receive placebo tablets, administered QD for 6 months
396163|NCT00631657|B1|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396164|NCT00631657|P3|Participant Flow|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
396165|NCT00631657|P2|Participant Flow|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
396166|NCT00631657|P1|Participant Flow|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days
396167|NCT00631657|O3|Outcome|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
396168|NCT00631657|O2|Outcome|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
396169|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period
396170|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months.
396171|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396172|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396173|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396174|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396175|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396176|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396177|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396178|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396179|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396180|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396181|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396182|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396186|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
396187|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396188|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
396189|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
396190|NCT00631657|E2|Reported Event|Placebo|Participants receive placebo tablets, administered QD
396191|NCT00631657|E1|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD
396192|NCT00631540|B1|Baseline|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396193|NCT00631540|P1|Participant Flow|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396194|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396195|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396196|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396197|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396198|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396199|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396200|NCT00631540|E1|Reported Event|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
396201|NCT00631488|B4|Baseline|Total|Total of all reporting groups
396202|NCT00631488|B3|Baseline|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396203|NCT00631488|B2|Baseline|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396204|NCT00631488|B1|Baseline|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396205|NCT00631488|P3|Participant Flow|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396206|NCT00631488|P2|Participant Flow|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396207|NCT00631488|P1|Participant Flow|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396208|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396209|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396210|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396211|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396212|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396233|NCT00631475|E1|Reported Event|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396213|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396214|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396215|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396216|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396217|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396218|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396219|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396220|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396221|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396222|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396223|NCT00631488|E3|Reported Event|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396224|NCT00631488|E2|Reported Event|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
396225|NCT00631488|E1|Reported Event|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
396226|NCT00631475|B1|Baseline|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396227|NCT00631475|P1|Participant Flow|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396228|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396229|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396230|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396231|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396232|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
396235|NCT00631449|B2|Baseline|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396236|NCT00631449|B1|Baseline|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396237|NCT00631449|P2|Participant Flow|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396238|NCT00631449|P1|Participant Flow|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396239|NCT00631449|O2|Outcome|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396240|NCT00631449|O1|Outcome|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396241|NCT00631449|E2|Reported Event|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396242|NCT00631449|E1|Reported Event|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
396243|NCT00631410|B3|Baseline|Total|Total of all reporting groups
396244|NCT00631410|B2|Baseline|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
396245|NCT00631410|B1|Baseline|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396246|NCT00631410|P2|Participant Flow|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396247|NCT00631410|P1|Participant Flow|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396248|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396249|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396250|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396251|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396252|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396311|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396312|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396313|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396253|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396254|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396255|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396256|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
396257|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
396258|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
396259|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396260|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396261|NCT00631410|E2|Reported Event|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
396262|NCT00631410|E1|Reported Event|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
396263|NCT00631371|B3|Baseline|Total|Total of all reporting groups
396264|NCT00631371|B2|Baseline|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396265|NCT00631371|B1|Baseline|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396266|NCT00631371|P2|Participant Flow|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396267|NCT00631371|P1|Participant Flow|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396314|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396315|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396316|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396268|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396269|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396270|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396271|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396272|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396273|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396274|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396275|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396276|NCT00631371|E2|Reported Event|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396277|NCT00631371|E1|Reported Event|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
396278|NCT00631358|B3|Baseline|Total|Total of all reporting groups
396279|NCT00631358|B2|Baseline|No Treatment|Healthy normal control group receiving no treatment
396280|NCT00631358|B1|Baseline|Maxidex|Maxidex 1 drop in each eye 2 times daily
396281|NCT00631358|P2|Participant Flow|No Treatment|Healthy normal control group receiving no treatment
396282|NCT00631358|P1|Participant Flow|Maxidex|Maxidex 1 drop in each eye 2 times daily
396283|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
396284|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
396285|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
396286|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
396287|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
396288|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
396289|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
396290|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
396291|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
396292|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
396293|NCT00631358|E2|Reported Event|No Treatment|Healthy normal control group receiving no treatment
396294|NCT00631358|E1|Reported Event|Maxidex|Maxidex 1 drop in each eye 2 times daily
396295|NCT00631189|B5|Baseline|Total|Total of all reporting groups
396296|NCT00631189|B4|Baseline|Rosuvastatin|Rosuvastatin 5 mg
396297|NCT00631189|B3|Baseline|Pravastatin|Pravastatin 40 mg
396298|NCT00631189|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
396299|NCT00631189|B1|Baseline|Initial Phase|Initial phase (between V1 and V2)
396300|NCT00631189|P4|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg
396301|NCT00631189|P3|Participant Flow|Pravastatin|Pravastatin 40 mg
396302|NCT00631189|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
396303|NCT00631189|P1|Participant Flow|Initial Phase|Initial phase (between V1 and V2)
396304|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396305|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396306|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396307|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396308|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396309|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396310|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396317|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396319|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396320|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396321|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396322|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396323|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396324|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396325|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396326|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396327|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396328|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396329|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396330|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396331|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396332|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396333|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396334|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396335|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396336|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
396337|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
396338|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
396339|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
396340|NCT00631189|E4|Reported Event|Rosuvastatin|Rosuvastatin 5 mg
396341|NCT00631189|E3|Reported Event|Pravastatin|Pravastatin 40 mg
396342|NCT00631189|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
396343|NCT00631189|E1|Reported Event|Initial Phase|Initial phase (between V1 and V2)
396344|NCT00631020|B1|Baseline|CBME +/- NRT|6 weeks of once a week CBME with optional 4 weeks NRT
396345|NCT00631020|P1|Participant Flow|CBME +/- NRT|6 weeks CBME with optional NRT for 4 weeks
396346|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396347|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396348|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396349|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396350|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396351|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396352|NCT00631020|E1|Reported Event|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
396353|NCT00631007|B7|Baseline|Total|Total of all reporting groups
396354|NCT00631007|B6|Baseline|Placebo|placebo administered once-daily
396355|NCT00631007|B5|Baseline|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
396356|NCT00631007|B4|Baseline|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
396357|NCT00631007|B3|Baseline|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
396358|NCT00631007|B2|Baseline|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
396359|NCT00631007|B1|Baseline|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
396360|NCT00631007|P6|Participant Flow|Placebo|placebo administered once-daily
396361|NCT00631007|P5|Participant Flow|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
396362|NCT00631007|P4|Participant Flow|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
396363|NCT00631007|P3|Participant Flow|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
396364|NCT00631007|P2|Participant Flow|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
396365|NCT00631007|P1|Participant Flow|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
396366|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
396367|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
396368|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
396369|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
396370|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
396371|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
396372|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
396373|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
396374|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
396375|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
396376|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
396377|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
396378|NCT00631007|E6|Reported Event|Placebo|placebo administered once-daily
396379|NCT00631007|E5|Reported Event|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
396380|NCT00631007|E4|Reported Event|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
396381|NCT00631007|E3|Reported Event|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
396382|NCT00631007|E2|Reported Event|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
396383|NCT00631007|E1|Reported Event|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
396384|NCT00630994|B1|Baseline|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396385|NCT00630994|P1|Participant Flow|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396386|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396387|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396388|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396389|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396390|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396391|NCT00630994|E1|Reported Event|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
396392|NCT00630955|B4|Baseline|Total|Total of all reporting groups
396393|NCT00630955|B3|Baseline|40 mg Memantine|
396394|NCT00630955|B2|Baseline|20 mg Memantine|
396395|NCT00630955|B1|Baseline|0 mg Memantine|
396396|NCT00630955|P3|Participant Flow|40 mg Memantine|Participants randomized to 40mg memantine PO qd
396397|NCT00630955|P2|Participant Flow|20 mg Memantine|Participants randomized to 20 mg memantine PO qd
396398|NCT00630955|P1|Participant Flow|0 mg Memantine|Participants who received placebo PO qd
396399|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
396400|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
396401|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
396402|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
396403|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
396404|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
396405|NCT00630955|E3|Reported Event|40 mg|Participants randomized to 40mg memantine
396406|NCT00630955|E2|Reported Event|20 mg|Participants randomized to 20 mg memantine
396407|NCT00630955|E1|Reported Event|0 mg|Participants who received placebo
396408|NCT00630916|B1|Baseline|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396409|NCT00630916|P1|Participant Flow|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396410|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396411|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396412|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396413|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396414|NCT00630916|E1|Reported Event|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
396415|NCT00630877|B4|Baseline|Total|Total of all reporting groups
396416|NCT00630877|B3|Baseline|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
396417|NCT00630877|B2|Baseline|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
396418|NCT00630877|B1|Baseline|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
396419|NCT00630877|P3|Participant Flow|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
396420|NCT00630877|P2|Participant Flow|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
396421|NCT00630877|P1|Participant Flow|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
396422|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
396423|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
396424|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
396425|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
396426|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
396427|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
396428|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
396429|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
396430|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
396431|NCT00630877|O3|Outcome|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
396432|NCT00630877|O2|Outcome|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
396433|NCT00630877|O1|Outcome|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
396434|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
396435|NCT00630877|E3|Reported Event|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
396436|NCT00630877|E2|Reported Event|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
396437|NCT00630877|E1|Reported Event|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
396438|NCT00630864|B1|Baseline|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396439|NCT00630864|P1|Participant Flow|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396440|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396441|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396442|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396443|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396444|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396445|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396446|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396447|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396448|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396449|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396450|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396451|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396452|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396453|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396454|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396455|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396456|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396457|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396458|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396459|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396460|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396461|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396462|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396463|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396464|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396465|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396466|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396467|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396468|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396469|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396470|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396471|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396472|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396473|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396474|NCT00630864|E1|Reported Event|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
396475|NCT00630838|B3|Baseline|Total|Total of all reporting groups
396476|NCT00630838|B2|Baseline|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
396477|NCT00630838|B1|Baseline|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
396478|NCT00630838|P2|Participant Flow|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
396479|NCT00630838|P1|Participant Flow|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
396480|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
396481|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
396482|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
396483|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
396521|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396522|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396523|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396833|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396484|NCT00630838|E2|Reported Event|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
396485|NCT00630838|E1|Reported Event|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
396486|NCT00630825|B5|Baseline|Total|Total of all reporting groups
396487|NCT00630825|B4|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396488|NCT00630825|B3|Baseline|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396489|NCT00630825|B2|Baseline|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396490|NCT00630825|B1|Baseline|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396491|NCT00630825|P4|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396492|NCT00630825|P3|Participant Flow|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396493|NCT00630825|P2|Participant Flow|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396494|NCT00630825|P1|Participant Flow|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396495|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396496|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396497|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396498|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396499|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396500|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396501|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396502|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396503|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396504|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396505|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396506|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396507|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396508|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396509|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396510|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396511|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396512|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396513|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396514|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396515|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396516|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396517|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396518|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396519|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396520|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396524|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396525|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396526|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396527|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396528|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396529|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396530|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396531|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396532|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396533|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396534|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396535|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396536|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396537|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396538|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396539|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396540|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396541|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396542|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396543|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396544|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396545|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396546|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396547|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396548|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396549|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396550|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396551|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396552|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396553|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396554|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396555|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396556|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396557|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396558|NCT00630825|E4|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
396559|NCT00630825|E3|Reported Event|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
396560|NCT00630825|E2|Reported Event|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
396561|NCT00630825|E1|Reported Event|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
396562|NCT00630786|B4|Baseline|Total|Total of all reporting groups
396563|NCT00630786|B3|Baseline|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396590|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396987|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396564|NCT00630786|B2|Baseline|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396565|NCT00630786|B1|Baseline|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396566|NCT00630786|P3|Participant Flow|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396567|NCT00630786|P2|Participant Flow|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396568|NCT00630786|P1|Participant Flow|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396569|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396570|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396571|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396572|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396573|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396574|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396575|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396576|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396577|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396578|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396579|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396580|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396581|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396582|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396583|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396584|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
396585|NCT00630786|E1|Reported Event|Panitumumab + AMG 655|
396586|NCT00630747|B1|Baseline|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396587|NCT00630747|P1|Participant Flow|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered by intravenous (IV) infusion once-weekly.
396588|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396589|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396988|NCT00628862|O3|Outcome|Placebo|Placebo
396591|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396592|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396593|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396594|NCT00630747|E1|Reported Event|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
396595|NCT00630734|B4|Baseline|Total|Total of all reporting groups
396596|NCT00630734|B3|Baseline|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396597|NCT00630734|B2|Baseline|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396598|NCT00630734|B1|Baseline|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396599|NCT00630734|P3|Participant Flow|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396600|NCT00630734|P2|Participant Flow|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
396601|NCT00630734|P1|Participant Flow|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396602|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396603|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
396604|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396605|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396606|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
396607|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396608|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396609|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
396610|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396611|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396612|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
396613|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396614|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396615|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396616|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396617|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396618|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396619|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396620|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396621|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396622|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396623|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396624|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396625|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396626|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396627|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396628|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396629|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396630|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396631|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1*1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
396632|NCT00630734|E3|Reported Event|Pravastatin + Darunavir/Ritonavir|Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
396633|NCT00630734|E2|Reported Event|Darunavir/Ritonavir Alone|Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
396634|NCT00630734|E1|Reported Event|Pravastatin Alone|Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
396635|NCT00630539|B5|Baseline|Total|Total of all reporting groups
396636|NCT00630539|B4|Baseline|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396637|NCT00630539|B3|Baseline|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396638|NCT00630539|B2|Baseline|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396639|NCT00630539|B1|Baseline|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396640|NCT00630539|P4|Participant Flow|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396641|NCT00630539|P3|Participant Flow|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396642|NCT00630539|P2|Participant Flow|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396643|NCT00630539|P1|Participant Flow|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396644|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396645|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396646|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396647|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396648|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396649|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396650|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396651|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396652|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396653|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396654|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396655|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396989|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396656|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396657|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396658|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396659|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396660|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396661|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396662|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396663|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396664|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396665|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396666|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396667|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396668|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396669|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396670|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396671|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396672|NCT00630539|O8|Outcome|Subjects on Ospemifene 30 mg/Day (Week 12)|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396673|NCT00630539|O7|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396674|NCT00630539|O6|Outcome|Subjects on Ospemifine 15 mg/Day (Week 12)|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396675|NCT00630539|O5|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396676|NCT00630539|O4|Outcome|Subjects on Ospemifene 5 mg/Day (Week 12)|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396677|NCT00630539|O3|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396678|NCT00630539|O2|Outcome|Subjects on Placebo (Week 12)|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396679|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396680|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396681|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396682|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396683|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396684|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396685|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396686|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396687|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396688|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396689|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396690|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396691|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396692|NCT00630539|E4|Reported Event|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
396693|NCT00630539|E3|Reported Event|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
396694|NCT00630539|E2|Reported Event|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
396695|NCT00630539|E1|Reported Event|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
396696|NCT00630487|B3|Baseline|Total|Total of all reporting groups
396697|NCT00630487|B2|Baseline|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396698|NCT00630487|B1|Baseline|Placebo|
396699|NCT00630487|P2|Participant Flow|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396700|NCT00630487|P1|Participant Flow|Placebo|
396791|NCT00630292|O1|Outcome|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
396990|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396701|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396702|NCT00630487|O1|Outcome|Placebo|
396703|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396704|NCT00630487|O1|Outcome|Placebo|
396705|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396706|NCT00630487|O1|Outcome|Placebo|
396707|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396708|NCT00630487|O1|Outcome|Placebo|
396709|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396710|NCT00630487|O1|Outcome|Placebo|
396711|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396712|NCT00630487|O1|Outcome|Placebo|
396713|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396714|NCT00630487|O1|Outcome|Placebo|
396715|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396716|NCT00630487|O1|Outcome|Placebo|
396717|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396718|NCT00630487|O1|Outcome|Placebo|
396719|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396720|NCT00630487|O1|Outcome|Placebo|
396721|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396722|NCT00630487|O1|Outcome|Placebo|
396723|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396724|NCT00630487|O1|Outcome|Placebo|
396725|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396726|NCT00630487|O1|Outcome|Placebo|
396727|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396728|NCT00630487|O1|Outcome|Placebo|
396729|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396730|NCT00630487|O1|Outcome|Placebo|
396731|NCT00630487|E2|Reported Event|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
396732|NCT00630487|E1|Reported Event|Placebo|
396733|NCT00630396|B1|Baseline|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396734|NCT00630396|P1|Participant Flow|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396735|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396736|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396737|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396738|NCT00630396|E1|Reported Event|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
396792|NCT00630292|E1|Reported Event|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
396739|NCT00630344|B1|Baseline|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
396740|NCT00630344|P1|Participant Flow|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
396741|NCT00630344|O1|Outcome|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
396742|NCT00630344|E1|Reported Event|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
396743|NCT00630331|B4|Baseline|Total|Total of all reporting groups
396744|NCT00630331|B3|Baseline|Placebo|One dose of phosphate buffered solution (PBS).
396745|NCT00630331|B2|Baseline|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396746|NCT00630331|B1|Baseline|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396747|NCT00630331|P3|Participant Flow|Placebo|One dose of phosphate buffered solution (PBS).
396748|NCT00630331|P2|Participant Flow|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396749|NCT00630331|P1|Participant Flow|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396750|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396751|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396752|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396753|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396754|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396755|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396756|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396757|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396758|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396759|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396760|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396761|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396762|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396763|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396764|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396765|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396766|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396767|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396768|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396769|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396770|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396771|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396772|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396773|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396774|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396775|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396776|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396777|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396778|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396779|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396780|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396781|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396782|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396783|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
396784|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396785|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396786|NCT00630331|E3|Reported Event|Placebo|One dose of phosphate buffered solution (PBS).
396787|NCT00630331|E2|Reported Event|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
396788|NCT00630331|E1|Reported Event|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
396789|NCT00630292|B1|Baseline|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
396790|NCT00630292|P1|Participant Flow|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
396794|NCT00630058|B2|Baseline|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396795|NCT00630058|B1|Baseline|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396796|NCT00630058|P2|Participant Flow|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396797|NCT00630058|P1|Participant Flow|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396798|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396799|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396800|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396801|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396802|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396803|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396804|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396805|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396806|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396807|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396808|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396809|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396810|NCT00630058|E2|Reported Event|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396811|NCT00630058|E1|Reported Event|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
396812|NCT00629850|B3|Baseline|Total|Total of all reporting groups
396813|NCT00629850|B2|Baseline|Control|This arm of the study will not receive the device.
396814|NCT00629850|B1|Baseline|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396815|NCT00629850|P2|Participant Flow|Control|This arm of the study will not receive the device.
396816|NCT00629850|P1|Participant Flow|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396817|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
396818|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396819|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
396820|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396821|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
396822|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396823|NCT00629850|E2|Reported Event|Control|This arm of the study will not receive the device.
396824|NCT00629850|E1|Reported Event|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
396825|NCT00629772|B3|Baseline|Total|Total of all reporting groups
396826|NCT00629772|B2|Baseline|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396827|NCT00629772|B1|Baseline|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396828|NCT00629772|P2|Participant Flow|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396829|NCT00629772|P1|Participant Flow|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396830|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396831|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396832|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396834|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396835|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396836|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396837|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396838|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396839|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396840|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396841|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396842|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
396843|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396844|NCT00629772|E2|Reported Event|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
396845|NCT00629772|E1|Reported Event|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.
396846|NCT00629707|B3|Baseline|Total|Total of all reporting groups
396847|NCT00629707|B2|Baseline|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
396848|NCT00629707|B1|Baseline|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
396849|NCT00629707|P2|Participant Flow|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
396850|NCT00629707|P1|Participant Flow|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
396851|NCT00629707|O2|Outcome|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
396852|NCT00629707|O1|Outcome|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
396853|NCT00629707|E2|Reported Event|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
396854|NCT00629707|E1|Reported Event|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
396855|NCT00629525|B1|Baseline|RAD001|RAD001 at a dose of 10 mg PO daily
396856|NCT00629525|P1|Participant Flow|RAD001|RAD001 at a dose of 10 mg PO daily
396857|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
396858|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
396859|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
396860|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
396861|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
396862|NCT00629525|E1|Reported Event|RAD001|RAD001 at a dose of 10 mg PO daily
396863|NCT00629499|B1|Baseline|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
396864|NCT00629499|P1|Participant Flow|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
396865|NCT00629499|O1|Outcome|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
396991|NCT00628862|O3|Outcome|Placebo|Placebo
396992|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396866|NCT00629499|E1|Reported Event|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
396867|NCT00629265|B3|Baseline|Total|Total of all reporting groups
396868|NCT00629265|B2|Baseline|Sham NMES Group|Sham NMES combined with exercise therapy
396869|NCT00629265|B1|Baseline|Active NMES Group|NMES therapy combined with exercise therapy
396870|NCT00629265|P2|Participant Flow|Sham NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396871|NCT00629265|P1|Participant Flow|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396872|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396873|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396874|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396875|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396876|NCT00629265|E2|Reported Event|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396877|NCT00629265|E1|Reported Event|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
396878|NCT00629239|B3|Baseline|Total|Total of all reporting groups
396879|NCT00629239|B2|Baseline|Placebo|Placebo
396880|NCT00629239|B1|Baseline|AZD4818|AZD4818 Turbuhaler
396881|NCT00629239|P2|Participant Flow|Placebo|Placebo
396882|NCT00629239|P1|Participant Flow|AZD4818|AZD4818 Turbuhaler
396883|NCT00629239|O2|Outcome|Placebo|Placebo
396884|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396885|NCT00629239|O2|Outcome|Placebo|Placebo
396886|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396887|NCT00629239|O2|Outcome|Placebo|Placebo
396888|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396889|NCT00629239|O2|Outcome|Placebo|Placebo
396890|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396891|NCT00629239|O2|Outcome|Placebo|Placebo
396892|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396893|NCT00629239|O2|Outcome|Placebo|Placebo
396894|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396895|NCT00629239|O2|Outcome|Placebo|Placebo
396896|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396897|NCT00629239|O2|Outcome|Placebo|Placebo
396898|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396899|NCT00629239|O2|Outcome|Placebo|Placebo
396900|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396901|NCT00629239|O2|Outcome|Placebo|Placebo
396902|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396903|NCT00629239|O2|Outcome|Placebo|Placebo
396904|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396905|NCT00629239|O2|Outcome|Placebo|Placebo
396906|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396907|NCT00629239|O2|Outcome|Placebo|Placebo
396908|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396909|NCT00629239|O2|Outcome|Placebo|Placebo
396910|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
396911|NCT00629239|E2|Reported Event|Placebo|Placebo
396912|NCT00629239|E1|Reported Event|AZD4818|AZD4818 Turbuhaler
396913|NCT00629018|B3|Baseline|Total|Total of all reporting groups
396914|NCT00629018|B2|Baseline|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
396915|NCT00629018|B1|Baseline|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
396916|NCT00629018|P2|Participant Flow|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
396917|NCT00629018|P1|Participant Flow|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
396918|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
396919|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
396920|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
396993|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396994|NCT00628862|O3|Outcome|Placebo|Placebo
396995|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396921|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
396922|NCT00629018|E2|Reported Event|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
396923|NCT00629018|E1|Reported Event|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
396924|NCT00628927|B3|Baseline|Total|Total of all reporting groups
396925|NCT00628927|B2|Baseline|Normal Control Participants|Normal Control participants recruited from the community
396926|NCT00628927|B1|Baseline|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
396927|NCT00628927|P2|Participant Flow|Normal Control Participants|Normal Control participants recruited from the community
396928|NCT00628927|P1|Participant Flow|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
396929|NCT00628927|O3|Outcome|Normal Controls|Normal controls recruited from the community.
396930|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw~1 participant sample was insufficient for analysis"
396931|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis
396932|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.~Data from 3 other participants was incomplete and therefore removed from the analysis."
396933|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness
396934|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
396935|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week
396936|NCT00628927|E2|Reported Event|Normal Control Participants|Normal Control participants recruited from the community
396937|NCT00628927|E1|Reported Event|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
396938|NCT00628901|B3|Baseline|Total|Total of all reporting groups
396939|NCT00628901|B2|Baseline|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396940|NCT00628901|B1|Baseline|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396941|NCT00628901|P2|Participant Flow|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396942|NCT00628901|P1|Participant Flow|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396943|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396944|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396945|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396946|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396947|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396996|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396997|NCT00628862|O3|Outcome|Placebo|Placebo
396998|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396948|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396949|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396950|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396951|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396952|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396953|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396954|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396955|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396956|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396957|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396958|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396959|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396960|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396961|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396962|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396963|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396964|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396965|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396966|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396967|NCT00628901|E2|Reported Event|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
396968|NCT00628901|E1|Reported Event|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
396969|NCT00628862|B4|Baseline|Total|Total of all reporting groups
396970|NCT00628862|B3|Baseline|Placebo|Placebo
396971|NCT00628862|B2|Baseline|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396972|NCT00628862|B1|Baseline|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396973|NCT00628862|P3|Participant Flow|Placebo|Placebo
396974|NCT00628862|P2|Participant Flow|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396975|NCT00628862|P1|Participant Flow|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396976|NCT00628862|O3|Outcome|Placebo|Placebo
396977|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396978|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396979|NCT00628862|O3|Outcome|Placebo|Placebo
396980|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396981|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396982|NCT00628862|O3|Outcome|Placebo|Placebo
396983|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
396984|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
396985|NCT00628862|O3|Outcome|Placebo|Placebo
396986|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
397008|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
397009|NCT00628862|O3|Outcome|Placebo|Placebo
397010|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
397011|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
397012|NCT00628862|O3|Outcome|Placebo|Placebo
397013|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
397014|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
397015|NCT00628862|E3|Reported Event|Placebo|Placebo
397016|NCT00628862|E2|Reported Event|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
397017|NCT00628862|E1|Reported Event|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
397018|NCT00628758|B3|Baseline|Total|Total of all reporting groups
397019|NCT00628758|B2|Baseline|Conventional BP|Conventional Best Practice for Treatment of asthma
397020|NCT00628758|B1|Baseline|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397021|NCT00628758|P2|Participant Flow|Conventional BP|Conventional Best Practice for Treatment of asthma
397022|NCT00628758|P1|Participant Flow|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397023|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
397024|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397025|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
397026|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397027|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
397028|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397029|NCT00628758|O2|Outcome|Conventional Best Practice (BP)|Conventional Best Practice for Treatment of asthma
397030|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
397031|NCT00628758|E2|Reported Event|Conventional BP|Conventional Best Practice for Treatment of asthma
397032|NCT00628758|E1|Reported Event|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
397033|NCT00628628|B3|Baseline|Total|Total of all reporting groups
397034|NCT00628628|B2|Baseline|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
397035|NCT00628628|B1|Baseline|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
397036|NCT00628628|P2|Participant Flow|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
397037|NCT00628628|P1|Participant Flow|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
397038|NCT00628628|O2|Outcome|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
397039|NCT00628628|O1|Outcome|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
397040|NCT00628628|E2|Reported Event|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
397041|NCT00628628|E1|Reported Event|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
397042|NCT00628446|B1|Baseline|Study Group|
397043|NCT00628446|P1|Participant Flow|Study Group|
397044|NCT00628446|O1|Outcome|Group 1|
397045|NCT00628446|O1|Outcome|Study Group|Cross-sectional study group
397046|NCT00628446|E1|Reported Event|Study Group|
397047|NCT00628407|B1|Baseline|Sternal Wall Pressure|
397048|NCT00628407|P1|Participant Flow|Sternal Wall Pressure|Subjects that received gentle incremental sternal wall pressure.
397049|NCT00628407|O1|Outcome|Sternal Wall Pressure|
397050|NCT00628407|E1|Reported Event|Sternal Wall Pressure|
397051|NCT00628355|B3|Baseline|Total|Total of all reporting groups
397052|NCT00628355|B2|Baseline|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
397053|NCT00628355|B1|Baseline|Ischemic Compression|Group received TENS plus Ischemic compression
397054|NCT00628355|P2|Participant Flow|Anesthesia Injection|Group received lidocaine injection
397055|NCT00628355|P1|Participant Flow|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
397056|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
397057|NCT00628355|O1|Outcome|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
397058|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
397059|NCT00628355|O1|Outcome|Ischemic Compression|Group received ischemic compression
397060|NCT00628355|E2|Reported Event|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
397061|NCT00628355|E1|Reported Event|Ischemic Compression|Group received Ischemic compression
397062|NCT00628251|B4|Baseline|Total|Total of all reporting groups
397063|NCT00628251|B3|Baseline|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397064|NCT00628251|B2|Baseline|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397065|NCT00628251|B1|Baseline|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397066|NCT00628251|P3|Participant Flow|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397067|NCT00628251|P2|Participant Flow|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397068|NCT00628251|P1|Participant Flow|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397069|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397070|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397071|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397072|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
398544|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
397073|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397074|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397075|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397076|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397077|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397078|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397079|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397080|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397081|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397082|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397083|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397084|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397085|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397086|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397087|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397088|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397089|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397090|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397091|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397092|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397093|NCT00628251|O4|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397094|NCT00628251|O3|Outcome|Olaparib 200 mg bd + Olaparib 400 mg bd,|Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
397095|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397096|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397097|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397098|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397099|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397100|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397101|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397102|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397103|NCT00628251|E3|Reported Event|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
397104|NCT00628251|E2|Reported Event|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
397105|NCT00628251|E1|Reported Event|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
397106|NCT00628212|B5|Baseline|Total|Total of all reporting groups
397107|NCT00628212|B4|Baseline|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397108|NCT00628212|B3|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397109|NCT00628212|B2|Baseline|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397110|NCT00628212|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397111|NCT00628212|P4|Participant Flow|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397112|NCT00628212|P3|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397113|NCT00628212|P2|Participant Flow|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397114|NCT00628212|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397115|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397116|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397117|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397118|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397119|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397120|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397121|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397122|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397123|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397124|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397125|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397126|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397127|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397128|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397129|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397130|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397131|NCT00628212|E4|Reported Event|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
397132|NCT00628212|E3|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397133|NCT00628212|E2|Reported Event|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
397134|NCT00628212|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397248|NCT00627861|E1|Reported Event|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
397135|NCT00628134|B1|Baseline|Cystic Fibrosis Subjects|"Subjects with cystic fibrosis~isotonic saline aerosol : single inhaled dose, 3ml by nebulizer~calfactant aerosol : single inhaled dose, 3ml by nebulizer"
397136|NCT00628134|P2|Participant Flow|Saline Aerosol Then Surfactant Aerosol|cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
397137|NCT00628134|P1|Participant Flow|Surfactant Aerosol Then Saline Aerosol|cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit
397138|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
397139|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
397140|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
397141|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
397142|NCT00628134|E2|Reported Event|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
397143|NCT00628134|E1|Reported Event|Subjects Inhaling Saline|Subjects with cystic fibrosis
397144|NCT00628108|B3|Baseline|Total|Total of all reporting groups
397145|NCT00628108|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397146|NCT00628108|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397147|NCT00628108|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397148|NCT00628108|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397149|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397150|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397151|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397152|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397153|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397154|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397155|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397156|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397157|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397158|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397159|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397160|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397161|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397162|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397163|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397164|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397165|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397166|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397167|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397168|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397169|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397170|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397171|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397172|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397173|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397174|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397175|NCT00628108|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397176|NCT00628108|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
397177|NCT00628030|B3|Baseline|Total|Total of all reporting groups
397178|NCT00628030|B2|Baseline|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397179|NCT00628030|B1|Baseline|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397180|NCT00628030|P2|Participant Flow|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397181|NCT00628030|P1|Participant Flow|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397182|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397183|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397184|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397249|NCT00627679|B1|Baseline|All Patients|All patients that were enrolled in the study.
397318|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
400683|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
397185|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397186|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397187|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397188|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397189|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397190|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
397191|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397192|NCT00628030|E2|Reported Event|Wellness Group|The placebo control group attended a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, parents received pedometers for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.Followed up for 6 months.
397193|NCT00628030|E1|Reported Event|NOURISH|The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differed only in duration. They covered the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics provided information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
397194|NCT00627926|B4|Baseline|Total|Total of all reporting groups
397195|NCT00627926|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397196|NCT00627926|B2|Baseline|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397197|NCT00627926|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397198|NCT00627926|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397199|NCT00627926|P2|Participant Flow|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397200|NCT00627926|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397201|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397202|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397203|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397204|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397205|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397206|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397207|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397208|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397209|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397210|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397211|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397212|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397213|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397214|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397215|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397216|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397217|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397218|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397219|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397220|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397221|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397222|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397223|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397224|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397225|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397226|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397227|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397228|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
398310|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
397229|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397230|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397231|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397232|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397233|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397234|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397235|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397236|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397237|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397238|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397239|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397240|NCT00627926|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397241|NCT00627926|E2|Reported Event|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
397242|NCT00627926|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
397243|NCT00627861|B1|Baseline|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
397244|NCT00627861|P1|Participant Flow|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
397245|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks
397246|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks.
397247|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
397250|NCT00627679|P4|Participant Flow|Treatment D, A, C, B|Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
397251|NCT00627679|P3|Participant Flow|Treatment C, D, B, A|Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5
397252|NCT00627679|P2|Participant Flow|Treatment B, C, A, D|Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
397253|NCT00627679|P1|Participant Flow|Treatment A, B, D, C|Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
397254|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397255|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397256|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397257|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397258|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397259|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397260|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397261|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397262|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397263|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397264|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397265|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397266|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397267|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397268|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397269|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397270|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397271|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397272|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397273|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397274|NCT00627679|E4|Reported Event|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
397275|NCT00627679|E3|Reported Event|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
397276|NCT00627679|E2|Reported Event|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
397277|NCT00627679|E1|Reported Event|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
397278|NCT00627523|B3|Baseline|Total|Total of all reporting groups
397279|NCT00627523|B2|Baseline|Control|This group was the untreated control group and was not administered placebo.
397280|NCT00627523|B1|Baseline|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397281|NCT00627523|P2|Participant Flow|Control|This group was the untreated control group and was not administered placebo.
397282|NCT00627523|P1|Participant Flow|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397283|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397284|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397285|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397317|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
398545|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
397286|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397287|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397288|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397289|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397290|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397291|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397292|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397293|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397294|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397295|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397296|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397297|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397298|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397299|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397300|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397301|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
397302|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397303|NCT00627523|E2|Reported Event|Control|This group was the untreated control group and was not administered placebo.
397304|NCT00627523|E1|Reported Event|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
397305|NCT00627497|B5|Baseline|Total|Total of all reporting groups
397306|NCT00627497|B4|Baseline|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397307|NCT00627497|B3|Baseline|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397308|NCT00627497|B2|Baseline|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397309|NCT00627497|B1|Baseline|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397310|NCT00627497|P4|Participant Flow|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397311|NCT00627497|P3|Participant Flow|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397312|NCT00627497|P2|Participant Flow|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397313|NCT00627497|P1|Participant Flow|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397314|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397315|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397316|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397319|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397320|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397321|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397322|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397323|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397324|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397325|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397326|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397327|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397328|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397329|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397330|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397331|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397332|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397333|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397334|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397335|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397336|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397337|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397338|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397339|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397340|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397341|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397342|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397343|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397344|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397345|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397346|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397347|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397348|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397349|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397350|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397351|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397352|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397353|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397354|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397355|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397356|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397357|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397358|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397359|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397360|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397361|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397362|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397363|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397364|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397365|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397366|NCT00627497|E4|Reported Event|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
397367|NCT00627497|E3|Reported Event|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397368|NCT00627497|E2|Reported Event|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
397369|NCT00627497|E1|Reported Event|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
397370|NCT00627445|B3|Baseline|Total|Total of all reporting groups
397371|NCT00627445|B2|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397372|NCT00627445|B1|Baseline|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397373|NCT00627445|P2|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397374|NCT00627445|P1|Participant Flow|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397375|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397376|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397377|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397378|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397379|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397380|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397381|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397382|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397383|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397384|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397385|NCT00627445|O2|Outcome|BIAsp 30-30|Individually adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin (500-2000 mg up to three times daily)
397386|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individually adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch in combination with metformin (500-2000 mg up to three times daily)
397387|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397388|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397389|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397390|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397391|NCT00627445|E2|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
397392|NCT00627445|E1|Reported Event|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
397393|NCT00627406|B5|Baseline|Total|Total of all reporting groups
397394|NCT00627406|B4|Baseline|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397395|NCT00627406|B3|Baseline|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
397396|NCT00627406|B2|Baseline|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397397|NCT00627406|B1|Baseline|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
400684|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
397398|NCT00627406|P4|Participant Flow|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397399|NCT00627406|P3|Participant Flow|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
397400|NCT00627406|P2|Participant Flow|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397401|NCT00627406|P1|Participant Flow|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
397402|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397403|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
397404|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397405|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
397406|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397407|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
397408|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397409|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
397410|NCT00627406|E4|Reported Event|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397411|NCT00627406|E3|Reported Event|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
397412|NCT00627406|E2|Reported Event|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
397413|NCT00627406|E1|Reported Event|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
397414|NCT00627393|B3|Baseline|Total|Total of all reporting groups
397415|NCT00627393|B2|Baseline|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397416|NCT00627393|B1|Baseline|Control Arm|Received antimicrobial therapy alone.
397417|NCT00627393|P2|Participant Flow|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397418|NCT00627393|P1|Participant Flow|Control Arm|Received antimicrobial therapy alone.
397419|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
397420|NCT00627393|O1|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397421|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
397422|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397423|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
397424|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397425|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
397426|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397427|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
398546|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
397428|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397429|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
397430|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397431|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
397432|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397433|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
397434|NCT00627393|E2|Reported Event|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
397435|NCT00627393|E1|Reported Event|Control Arm|Received antimicrobial therapy alone.
397436|NCT00627094|B3|Baseline|Total|Total of all reporting groups
397437|NCT00627094|B2|Baseline|Biatain|Biatain foam dressing without ibuprofen - control
397438|NCT00627094|B1|Baseline|Biatain Ibu|Biatain foam dressing containing ibuprofen
397439|NCT00627094|P2|Participant Flow|Biatain|Biatain Foam dressing without ibuprofen - control
397440|NCT00627094|P1|Participant Flow|Biatain Ibu|Biatain foam dressing containing Ibuprofen
397441|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
397442|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
397443|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
397444|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
397445|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
397446|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
397447|NCT00627094|O2|Outcome|Biatain|Biatain foam dressing without ibuprofen - control
397448|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing ibuprofen
397449|NCT00627094|E2|Reported Event|Biatain|Biatain foam dressing without ibuprofen
397450|NCT00627094|E1|Reported Event|Biatain Ibu|Biatain foam dressing containing ibuprofen
397451|NCT00627042|B1|Baseline|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397452|NCT00627042|P1|Participant Flow|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397453|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397454|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397455|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397456|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397457|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397458|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397459|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397460|NCT00627042|E1|Reported Event|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
397461|NCT00627016|B3|Baseline|Total|Total of all reporting groups
397462|NCT00627016|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397463|NCT00627016|B1|Baseline|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397464|NCT00627016|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397465|NCT00627016|P1|Participant Flow|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397466|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397467|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397468|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397469|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397470|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397471|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397472|NCT00627016|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
397473|NCT00627016|E1|Reported Event|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
397474|NCT00626925|B3|Baseline|Total|Total of all reporting groups
397475|NCT00626925|B2|Baseline|Total Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397476|NCT00626925|B1|Baseline|Total Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397477|NCT00626925|P2|Participant Flow|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397478|NCT00626925|P1|Participant Flow|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397479|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397480|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397481|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397482|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397483|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397484|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397485|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397486|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397487|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397488|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397489|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397490|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397491|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397492|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397493|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397494|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397495|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397496|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397497|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397498|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397499|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397500|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397501|NCT00626925|E2|Reported Event|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397502|NCT00626925|E1|Reported Event|Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
397503|NCT00626821|B1|Baseline|SenSura|Test of SenSura for 6-8 weeks
397504|NCT00626821|P1|Participant Flow|SenSura|Test of SenSura for 6-8 weeks
397505|NCT00626821|O1|Outcome|SenSura|Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
397506|NCT00626821|E1|Reported Event|SenSura|Test of SenSura for 6-8 weeks
397507|NCT00626808|B5|Baseline|Total|Total of all reporting groups
397508|NCT00626808|B4|Baseline|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397509|NCT00626808|B3|Baseline|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397510|NCT00626808|B2|Baseline|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397511|NCT00626808|B1|Baseline|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397512|NCT00626808|P4|Participant Flow|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397513|NCT00626808|P3|Participant Flow|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397514|NCT00626808|P2|Participant Flow|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397515|NCT00626808|P1|Participant Flow|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397516|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397517|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397518|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397519|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397520|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397521|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397522|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397523|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397524|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397525|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397526|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397527|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397528|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397529|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397530|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397531|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397532|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397533|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397534|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397535|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397536|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397537|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397538|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397539|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397540|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397541|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397542|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397543|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397544|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397545|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397546|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397547|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397548|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397549|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397550|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397551|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397552|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397553|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397554|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397555|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397556|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397557|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397558|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397559|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397560|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397561|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397562|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397563|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397564|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397565|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397566|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397567|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397568|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397569|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397570|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397571|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397572|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397573|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397574|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
397575|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397576|NCT00626808|E4|Reported Event|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
397577|NCT00626808|E3|Reported Event|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
397578|NCT00626808|E2|Reported Event|Children 24-59 Months With Asthma|
397579|NCT00626808|E1|Reported Event|Participants Less Than 24 Months of Age|Participants less than 24 months of age
397580|NCT00626782|B3|Baseline|Total|Total of all reporting groups
397581|NCT00626782|B2|Baseline|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
397582|NCT00626782|B1|Baseline|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
397583|NCT00626782|P2|Participant Flow|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
397584|NCT00626782|P1|Participant Flow|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
397585|NCT00626782|O2|Outcome|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
397586|NCT00626782|O1|Outcome|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
397587|NCT00626782|E2|Reported Event|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
397588|NCT00626782|E1|Reported Event|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
397589|NCT00626743|B3|Baseline|Total|Total of all reporting groups
397590|NCT00626743|B2|Baseline|Asan Medical Center|
397591|NCT00626743|B1|Baseline|INJE University Pusan Paik Hospital|
397592|NCT00626743|P2|Participant Flow|Placebo|"Tablet which has the same appearance and taste but doesn’t contain active ingredient~SK3530 100mg, Placebo, Amlodipine"
397593|NCT00626743|P1|Participant Flow|SK3530|"Active Drug~SK3530 100mg, Placebo, Amlodipine"
397594|NCT00626743|O2|Outcome|Amlodipine + Placebo|
397595|NCT00626743|O1|Outcome|Amlodipine + SK3530|
397596|NCT00626743|O2|Outcome|Amlodipine + Placebo|
397597|NCT00626743|O1|Outcome|Amlodipine + SK3530|
397598|NCT00626743|E2|Reported Event|Amlodipine + Placebo|
397599|NCT00626743|E1|Reported Event|Amlodipine + SK3530|
397600|NCT00626639|B3|Baseline|Total|Total of all reporting groups
397601|NCT00626639|B2|Baseline|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397602|NCT00626639|B1|Baseline|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397603|NCT00626639|P2|Participant Flow|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397604|NCT00626639|P1|Participant Flow|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
400685|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
397605|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397606|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397607|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397608|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397609|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397610|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397611|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397612|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397613|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397614|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397615|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397616|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397617|NCT00626639|E2|Reported Event|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397618|NCT00626639|E1|Reported Event|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
397619|NCT00626574|B3|Baseline|Total|Total of all reporting groups
397620|NCT00626574|B2|Baseline|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
397621|NCT00626574|B1|Baseline|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
397622|NCT00626574|P2|Participant Flow|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
397623|NCT00626574|P1|Participant Flow|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
397624|NCT00626574|O2|Outcome|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
397625|NCT00626574|O1|Outcome|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
397626|NCT00626574|E2|Reported Event|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
397627|NCT00626574|E1|Reported Event|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
397628|NCT00626561|B1|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
397629|NCT00626561|P1|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
397630|NCT00626561|O1|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
397631|NCT00626561|E1|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
397632|NCT00626548|B3|Baseline|Total|Total of all reporting groups
397633|NCT00626548|B2|Baseline|Placebo|Placebo oral tablet once daily
397634|NCT00626548|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
397635|NCT00626548|P2|Participant Flow|Placebo|Placebo oral tablet once daily
397636|NCT00626548|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
397637|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
397638|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
397639|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
397640|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
397641|NCT00626548|E2|Reported Event|Placebo|Placebo oral tablet once daily
397642|NCT00626548|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
397643|NCT00626522|B7|Baseline|Total|Total of all reporting groups
397644|NCT00626522|B6|Baseline|Placebo|Placebo once-daily
397645|NCT00626522|B5|Baseline|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397646|NCT00626522|B4|Baseline|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397647|NCT00626522|B3|Baseline|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397648|NCT00626522|B2|Baseline|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397649|NCT00626522|B1|Baseline|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397650|NCT00626522|P6|Participant Flow|Placebo|Placebo once-daily
397651|NCT00626522|P5|Participant Flow|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397652|NCT00626522|P4|Participant Flow|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397653|NCT00626522|P3|Participant Flow|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397654|NCT00626522|P2|Participant Flow|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397655|NCT00626522|P1|Participant Flow|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397656|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
397657|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397658|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397659|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397660|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397661|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397662|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
397663|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397664|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397665|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397666|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397667|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397668|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
397669|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397670|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397671|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397672|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397673|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397674|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
397675|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397676|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397677|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397678|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397679|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397680|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
397681|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397682|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397683|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397684|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397685|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397686|NCT00626522|E6|Reported Event|Placebo|Placebo once-daily
397687|NCT00626522|E5|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
397688|NCT00626522|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
397689|NCT00626522|E3|Reported Event|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
397690|NCT00626522|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
397691|NCT00626522|E1|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
397692|NCT00626444|B1|Baseline|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
397693|NCT00626444|P1|Participant Flow|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
397694|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
397695|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
397696|NCT00626444|E1|Reported Event|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
397697|NCT00626431|B3|Baseline|Total|Total of all reporting groups
397698|NCT00626431|B2|Baseline|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397699|NCT00626431|B1|Baseline|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397700|NCT00626431|P2|Participant Flow|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397701|NCT00626431|P1|Participant Flow|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397702|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397703|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397704|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397705|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397706|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397735|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
398547|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
397707|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397708|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397709|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397710|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397711|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397712|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397713|NCT00626431|E2|Reported Event|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397714|NCT00626431|E1|Reported Event|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
397715|NCT00626392|B7|Baseline|Total|Total of all reporting groups
397716|NCT00626392|B6|Baseline|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397717|NCT00626392|B5|Baseline|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397718|NCT00626392|B4|Baseline|NER 1000; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397719|NCT00626392|B3|Baseline|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397720|NCT00626392|B2|Baseline|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397721|NCT00626392|B1|Baseline|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397722|NCT00626392|P6|Participant Flow|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397723|NCT00626392|P5|Participant Flow|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397724|NCT00626392|P4|Participant Flow|NER 1000; ASA run-in; ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
397725|NCT00626392|P3|Participant Flow|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397726|NCT00626392|P2|Participant Flow|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397727|NCT00626392|P1|Participant Flow|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
397728|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
397729|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
397730|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
397731|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
397732|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
397733|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
397734|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
398548|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
397736|NCT00626392|E2|Reported Event|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
397737|NCT00626392|E1|Reported Event|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
397738|NCT00626327|B4|Baseline|Total|Total of all reporting groups
397739|NCT00626327|B3|Baseline|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397740|NCT00626327|B2|Baseline|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397741|NCT00626327|B1|Baseline|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397742|NCT00626327|P3|Participant Flow|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397743|NCT00626327|P2|Participant Flow|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397744|NCT00626327|P1|Participant Flow|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397745|NCT00626327|O3|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397746|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397747|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397748|NCT00626327|O3|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397749|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397750|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397751|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
397752|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
397753|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397754|NCT00626327|O1|Outcome|MenACWY-CRM +MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397755|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397756|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397757|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
397758|NCT00626327|O1|Outcome|MenACWY-CRM + MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397759|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
397760|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397761|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397762|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397763|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397764|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397765|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397766|NCT00626327|E3|Reported Event|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
397767|NCT00626327|E2|Reported Event|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
397768|NCT00626327|E1|Reported Event|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
397769|NCT00626275|B1|Baseline|All Treated Participants|All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B.
397770|NCT00626275|P8|Participant Flow|Part B: Placebo|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397771|NCT00626275|P7|Participant Flow|Part B: ADL5859 100 mg|ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study
397772|NCT00626275|P6|Participant Flow|Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose."
397800|NCT00626275|O3|Outcome|ADL5859 - 200mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397773|NCT00626275|P5|Participant Flow|Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
397774|NCT00626275|P4|Participant Flow|Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
397775|NCT00626275|P3|Participant Flow|Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
397776|NCT00626275|P2|Participant Flow|Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
397777|NCT00626275|P1|Participant Flow|Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose"
397778|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397779|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397780|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397781|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397782|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397783|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397784|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397785|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397786|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397787|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397788|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397789|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397790|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397791|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397792|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397793|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397794|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397795|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397796|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397797|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397798|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397799|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
399028|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
397801|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397802|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397803|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397804|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397805|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397806|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397807|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397808|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397809|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397810|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397811|NCT00626275|E5|Reported Event|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
397812|NCT00626275|E4|Reported Event|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
397813|NCT00626275|E3|Reported Event|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397814|NCT00626275|E2|Reported Event|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
397815|NCT00626275|E1|Reported Event|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
397816|NCT00626210|B1|Baseline|Modafinil|Open label study in which all participants get modafinil
397817|NCT00626210|P1|Participant Flow|Modafinil|daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
397818|NCT00626210|O1|Outcome|Modafinil|
397819|NCT00626210|E1|Reported Event|Modafinil|
397820|NCT00626093|B1|Baseline|Group 1|
397821|NCT00626093|P1|Participant Flow|Cardiac Resynchronization Therapy - Defibrillators (CRT-D)|All patients enrolled were indicated for a CRT-D.
397822|NCT00626093|O1|Outcome|CRT-D|
397823|NCT00626093|O1|Outcome|CRT-D|
397824|NCT00626093|E1|Reported Event|Group 1|
397825|NCT00626028|B3|Baseline|Total|Total of all reporting groups
397826|NCT00626028|B2|Baseline|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397827|NCT00626028|B1|Baseline|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397828|NCT00626028|P2|Participant Flow|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397829|NCT00626028|P1|Participant Flow|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397830|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397831|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397832|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397833|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397834|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397835|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397836|NCT00626028|E2|Reported Event|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
397837|NCT00626028|E1|Reported Event|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
397838|NCT00625989|B1|Baseline|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397839|NCT00625989|P2|Participant Flow|Allergen Then Diluent Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
397873|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397874|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397840|NCT00625989|P1|Participant Flow|Diluent Then Allergen Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
397841|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397842|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397843|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397844|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397845|NCT00625989|E1|Reported Event|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
397846|NCT00625872|B3|Baseline|Total|Total of all reporting groups
397847|NCT00625872|B2|Baseline|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397848|NCT00625872|B1|Baseline|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397849|NCT00625872|P2|Participant Flow|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397850|NCT00625872|P1|Participant Flow|Somatropin|Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397851|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397852|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397853|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397854|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397855|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397856|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397857|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397858|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397859|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397860|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397861|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397862|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397863|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397864|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397865|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397866|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397867|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397868|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397869|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397870|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397871|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397872|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
400686|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
397875|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397876|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397877|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397878|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397879|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397880|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397881|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397882|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397883|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397884|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397885|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397886|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397887|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397888|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397889|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397890|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397891|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397892|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397893|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397894|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397895|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397896|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397897|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397898|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397899|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397900|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397901|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397902|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397903|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397904|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397905|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397906|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397907|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
400687|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
397908|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397909|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397910|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397911|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397912|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397913|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397914|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397915|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397916|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397917|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397918|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397919|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397920|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397921|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397922|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397923|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397924|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397925|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397926|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397927|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397928|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397929|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397930|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397931|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397932|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397933|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397934|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397935|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397936|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397937|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397938|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397939|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397940|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
402375|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
397941|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397942|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397943|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397944|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397945|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397946|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397947|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397948|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397949|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397950|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397951|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397952|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397953|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397954|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397955|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397956|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397957|NCT00625872|E2|Reported Event|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
397958|NCT00625872|E1|Reported Event|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
397959|NCT00625820|B1|Baseline|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
397960|NCT00625820|P1|Participant Flow|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
397961|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
397962|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
397963|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|
397964|NCT00625820|E1|Reported Event|BH4, BH4 + Vit C|
397965|NCT00625742|B1|Baseline|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
397966|NCT00625742|P1|Participant Flow|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
397967|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
397968|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
397969|NCT00625742|E1|Reported Event|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
397970|NCT00625729|B1|Baseline|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
398001|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
402376|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
397971|NCT00625729|P1|Participant Flow|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397972|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397973|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397974|NCT00625729|O1|Outcome|Responder Patients|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
397975|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397976|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397977|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397978|NCT00625729|E1|Reported Event|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
397979|NCT00625586|B1|Baseline|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397980|NCT00625586|P1|Participant Flow|RAV12 Plus Gemcitabine|RAV12 monoclonal antibody plus gemcitabine
397981|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397982|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397983|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397984|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397985|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397986|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397987|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397988|NCT00625586|E1|Reported Event|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
397989|NCT00625404|B3|Baseline|Total|Total of all reporting groups
397990|NCT00625404|B2|Baseline|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397991|NCT00625404|B1|Baseline|Truvada Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397992|NCT00625404|P2|Participant Flow|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397993|NCT00625404|P1|Participant Flow|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
397994|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397995|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
397996|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397997|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
397998|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
397999|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398000|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398002|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398003|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398004|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398005|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398006|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398007|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398008|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398009|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398010|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398011|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398012|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398013|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398014|NCT00625404|O2|Outcome|Placebo Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
398015|NCT00625404|O1|Outcome|Truvada Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
398016|NCT00625404|E2|Reported Event|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
398017|NCT00625404|E1|Reported Event|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
398018|NCT00625391|B5|Baseline|Total|Total of all reporting groups
398019|NCT00625391|B4|Baseline|GTP+Tai Chi|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
398020|NCT00625391|B3|Baseline|Placebo+Tai Chi|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
398021|NCT00625391|B2|Baseline|Green Tea Polyphenols (GTP)|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
398022|NCT00625391|B1|Baseline|Placebo|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
398023|NCT00625391|P4|Participant Flow|GTP + Tai Chi Group|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
398024|NCT00625391|P3|Participant Flow|Placebo + Tai Chi Group|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
398025|NCT00625391|P2|Participant Flow|Green Tea Polyphenols (GTP) Group|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
398026|NCT00625391|P1|Participant Flow|Placebo Group|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
398027|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
398028|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
398029|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
398030|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
398031|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
398032|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
398033|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
398034|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
398035|NCT00625391|E4|Reported Event|GTP+TC|Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
398036|NCT00625391|E3|Reported Event|Placebo+Tai Chi (TC)|Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
398037|NCT00625391|E2|Reported Event|Green Tea Polyphenols (GTP)|Green tea polyphenols at 500 mg daily for 24 weeks
398038|NCT00625391|E1|Reported Event|Placebo|Medicinal starch at 500 mg daily for 24 weeks
398311|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
398039|NCT00625365|B1|Baseline|DEFINITY (Perflutren Lipid Microsphere)|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398040|NCT00625365|P1|Participant Flow|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398041|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398042|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398043|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398044|NCT00625365|E1|Reported Event|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
398045|NCT00625183|B1|Baseline|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398046|NCT00625183|P1|Participant Flow|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398047|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398048|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398049|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398050|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398051|NCT00625183|E1|Reported Event|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
398052|NCT00625131|B3|Baseline|Total|Total of all reporting groups
398053|NCT00625131|B2|Baseline|Arm 2|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398054|NCT00625131|B1|Baseline|Arm 1|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398055|NCT00625131|P3|Participant Flow|Not Randomized|This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
398056|NCT00625131|P2|Participant Flow|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398057|NCT00625131|P1|Participant Flow|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398058|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398059|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398060|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398061|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398062|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398063|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398064|NCT00625131|E2|Reported Event|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398065|NCT00625131|E1|Reported Event|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
398066|NCT00624832|B5|Baseline|Total|Total of all reporting groups
398090|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
398091|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
398067|NCT00624832|B4|Baseline|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
398068|NCT00624832|B3|Baseline|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398069|NCT00624832|B2|Baseline|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398070|NCT00624832|B1|Baseline|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
398071|NCT00624832|P4|Participant Flow|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
398072|NCT00624832|P3|Participant Flow|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398073|NCT00624832|P2|Participant Flow|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398074|NCT00624832|P1|Participant Flow|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
398075|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
398076|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398077|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
398078|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
398079|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398080|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
398081|NCT00624832|E4|Reported Event|Placebo Comparator|Placebo comparator
398082|NCT00624832|E3|Reported Event|Xolair (IgE= 301- 699 IU/mL)|Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398083|NCT00624832|E2|Reported Event|Xolair (IgE= 700- 2000 IU/mL)|Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
398084|NCT00624832|E1|Reported Event|Xolair (IgE= 30- 300 IU/mL)|Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
398085|NCT00624806|B3|Baseline|Total|Total of all reporting groups
398086|NCT00624806|B2|Baseline|Weekly Group|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
398087|NCT00624806|B1|Baseline|Daily Group|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
398088|NCT00624806|P2|Participant Flow|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
398089|NCT00624806|P1|Participant Flow|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
398312|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
398092|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
398093|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
398094|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
398095|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
398096|NCT00624806|E2|Reported Event|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
398097|NCT00624806|E1|Reported Event|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
398098|NCT00624780|B7|Baseline|Total|Total of all reporting groups
398099|NCT00624780|B6|Baseline|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398100|NCT00624780|B5|Baseline|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398101|NCT00624780|B4|Baseline|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398102|NCT00624780|B3|Baseline|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398103|NCT00624780|B2|Baseline|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398104|NCT00624780|B1|Baseline|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398313|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
398314|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
402377|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
398105|NCT00624780|P6|Participant Flow|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398106|NCT00624780|P5|Participant Flow|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398107|NCT00624780|P4|Participant Flow|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398108|NCT00624780|P3|Participant Flow|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398109|NCT00624780|P2|Participant Flow|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398110|NCT00624780|P1|Participant Flow|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398111|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398112|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398113|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398114|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398115|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398116|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398117|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398118|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398119|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398120|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398121|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398315|NCT00624559|E4|Reported Event|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
398122|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398123|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398124|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398125|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398126|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398127|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398128|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398129|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398130|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398316|NCT00624559|E3|Reported Event|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
398131|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398132|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398133|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398134|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398135|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398136|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398137|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398138|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398139|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398317|NCT00624559|E2|Reported Event|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
398140|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398141|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398142|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398143|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398144|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398145|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398146|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398147|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398148|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
399029|NCT00622869|E3|Reported Event|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids
398149|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398150|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398151|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398152|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398153|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398154|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398155|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398156|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398157|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
399108|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
398158|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398159|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398160|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398161|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398162|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398163|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398164|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398165|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398166|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
399109|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
398167|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398168|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398169|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398170|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398171|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398172|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398173|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398174|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398175|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398176|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
399030|NCT00622869|E2|Reported Event|Tacrolimus Elimination|Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids
398177|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398178|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398179|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398180|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398181|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398182|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398183|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398184|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398185|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
399100|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
398186|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398187|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398188|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398189|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398190|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398191|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398192|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398193|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398194|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
399101|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
398195|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398196|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398197|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398198|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398199|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398200|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398201|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398202|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398203|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398204|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398322|NCT00624520|P2|Participant Flow|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398205|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398206|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398207|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398208|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398209|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398210|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398211|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398212|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398213|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398223|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398323|NCT00624520|P1|Participant Flow|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398214|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398215|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398216|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398217|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398218|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398219|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398220|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398221|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398222|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398318|NCT00624559|E1|Reported Event|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
398319|NCT00624520|B3|Baseline|Total|Total of all reporting groups
398224|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398225|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398226|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398227|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398228|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398229|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398230|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398231|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398232|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398531|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398233|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398234|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398235|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398236|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398237|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398238|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398239|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398240|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398241|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398320|NCT00624520|B2|Baseline|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398532|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398242|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398243|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398244|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398245|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398246|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398247|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398248|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398249|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398321|NCT00624520|B1|Baseline|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398533|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398250|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398251|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398252|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398253|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398254|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398255|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398256|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398257|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398258|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398259|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398260|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398279|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398261|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398262|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398263|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398264|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398265|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398266|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398267|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398268|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398304|NCT00624559|P3|Participant Flow|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
398269|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398270|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398271|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398272|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398273|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398274|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398275|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398276|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398277|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398278|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398305|NCT00624559|P2|Participant Flow|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
398280|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398281|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398282|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
398283|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398284|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
398285|NCT00624780|E6|Reported Event|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398286|NCT00624780|E5|Reported Event|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398287|NCT00624780|E4|Reported Event|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398288|NCT00624780|E3|Reported Event|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398306|NCT00624559|P1|Participant Flow|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
398307|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
398308|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
398309|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
398289|NCT00624780|E2|Reported Event|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
398290|NCT00624780|E1|Reported Event|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
398291|NCT00624585|B1|Baseline|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398292|NCT00624585|P1|Participant Flow|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398293|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398294|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398295|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398296|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398297|NCT00624585|E1|Reported Event|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
398298|NCT00624559|B5|Baseline|Total|Total of all reporting groups
398299|NCT00624559|B4|Baseline|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
398300|NCT00624559|B3|Baseline|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
398301|NCT00624559|B2|Baseline|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
398302|NCT00624559|B1|Baseline|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
398303|NCT00624559|P4|Participant Flow|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
403135|NCT00613379|B2|Baseline|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
398324|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398325|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398326|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398327|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398328|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398329|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398330|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398331|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398332|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398333|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398334|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398335|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398336|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398337|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398338|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398339|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398340|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398341|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398342|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398343|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398344|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398345|NCT00624520|E2|Reported Event|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
398346|NCT00624520|E1|Reported Event|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
398347|NCT00624468|B3|Baseline|Total|Total of all reporting groups
398348|NCT00624468|B2|Baseline|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398349|NCT00624468|B1|Baseline|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398350|NCT00624468|P4|Participant Flow|Atacicept: SFU Period|Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
398351|NCT00624468|P3|Participant Flow|Placebo: SFU Period|Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.
398352|NCT00624468|P2|Participant Flow|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398353|NCT00624468|P1|Participant Flow|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398354|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398355|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398356|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398357|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398358|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398359|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398360|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398361|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398362|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398363|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398364|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398365|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398366|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398367|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398368|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398369|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398370|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398371|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398372|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398373|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398374|NCT00624468|E4|Reported Event|Atacicept: SFU Period|Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
398375|NCT00624468|E3|Reported Event|Placebo: SFU Period|Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
398376|NCT00624468|E2|Reported Event|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
398377|NCT00624468|E1|Reported Event|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
398378|NCT00624442|B6|Baseline|Total|Total of all reporting groups
398379|NCT00624442|B5|Baseline|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
398380|NCT00624442|B4|Baseline|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
398381|NCT00624442|B3|Baseline|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398382|NCT00624442|B2|Baseline|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398383|NCT00624442|B1|Baseline|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398534|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398535|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398384|NCT00624442|P5|Participant Flow|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
398385|NCT00624442|P4|Participant Flow|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
398386|NCT00624442|P3|Participant Flow|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398387|NCT00624442|P2|Participant Flow|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398388|NCT00624442|P1|Participant Flow|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
398389|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398390|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398391|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398392|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398393|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398394|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398395|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398396|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398397|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398398|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398399|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398400|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
398401|NCT00624442|E12|Reported Event|Cohort 5, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
398402|NCT00624442|E11|Reported Event|Cohort 5, Loading Dose of 0.75 mg/kg/hr|Loading dose is first hour of IV infusion.
398403|NCT00624442|E10|Reported Event|Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
398404|NCT00624442|E9|Reported Event|Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr|Loading dose is first hour of IV infusion.
398405|NCT00624442|E8|Reported Event|Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr|Loading dose is first hour of IV infusion.
398406|NCT00624442|E7|Reported Event|Cohort 2, Loading Dose of 2.2 mg/kg/hr|Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
398407|NCT00624442|E6|Reported Event|Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
398408|NCT00624442|E5|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr|Loading dose is the first hour of IV infusion.
398409|NCT00624442|E4|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr|Loading dose is the first hour of IV infusion.
398410|NCT00624442|E3|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr|Loading dose is the first hour of IV infusion.
398411|NCT00624442|E2|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr|Loading dose is the first hour of IV infusion.
398412|NCT00624442|E1|Reported Event|Placebo|
398413|NCT00624416|B1|Baseline|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398414|NCT00624416|P1|Participant Flow|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398415|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398416|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398417|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398536|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
403136|NCT00613379|B1|Baseline|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
398418|NCT00624416|E1|Reported Event|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
398419|NCT00624377|B1|Baseline|Spiriva 18µg With HandiHaler Device on COPD Patients|
398420|NCT00624377|P1|Participant Flow|Spiriva 18µg With HandiHaler Device on COPD Patients|
398421|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398422|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398423|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398424|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398425|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398426|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398427|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398428|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
398429|NCT00624377|E1|Reported Event|Spiriva 18µg With HandiHaler Device on COPD Patients|
398430|NCT00624338|B4|Baseline|Total|Total of all reporting groups
398431|NCT00624338|B3|Baseline|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398432|NCT00624338|B2|Baseline|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398433|NCT00624338|B1|Baseline|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398434|NCT00624338|P3|Participant Flow|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398435|NCT00624338|P2|Participant Flow|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398436|NCT00624338|P1|Participant Flow|Atacicept 75 mg|75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398437|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398438|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398439|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398440|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398441|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398442|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398443|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398444|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398445|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398446|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398447|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398448|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398449|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398450|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398451|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398452|NCT00624338|E3|Reported Event|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398453|NCT00624338|E2|Reported Event|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398537|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398538|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398454|NCT00624338|E1|Reported Event|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
398455|NCT00624286|B3|Baseline|Total|Total of all reporting groups
398456|NCT00624286|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398457|NCT00624286|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398458|NCT00624286|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398459|NCT00624286|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398460|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398461|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398462|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398463|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398464|NCT00624286|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398465|NCT00624286|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
398466|NCT00624221|B3|Baseline|Total|Total of all reporting groups
398467|NCT00624221|B2|Baseline|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
398468|NCT00624221|B1|Baseline|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
398469|NCT00624221|P2|Participant Flow|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
398470|NCT00624221|P1|Participant Flow|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
398471|NCT00624221|O2|Outcome|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
398472|NCT00624221|O1|Outcome|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
398473|NCT00624221|E2|Reported Event|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
398474|NCT00624221|E1|Reported Event|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
398475|NCT00624195|B3|Baseline|Total|Total of all reporting groups
398476|NCT00624195|B2|Baseline|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
398477|NCT00624195|B1|Baseline|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
398478|NCT00624195|P2|Participant Flow|Non-CNS-targeted|"Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
398539|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398540|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398541|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398542|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398543|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398479|NCT00624195|P1|Participant Flow|CNS-targeted|"CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
398480|NCT00624195|O2|Outcome|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
398481|NCT00624195|O1|Outcome|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
398482|NCT00624195|E2|Reported Event|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
398483|NCT00624195|E1|Reported Event|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
398484|NCT00624065|B3|Baseline|Total|Total of all reporting groups
398485|NCT00624065|B2|Baseline|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
398486|NCT00624065|B1|Baseline|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
398487|NCT00624065|P2|Participant Flow|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
398488|NCT00624065|P1|Participant Flow|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
398489|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
398490|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
398491|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
398492|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
398493|NCT00624065|E2|Reported Event|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
398494|NCT00624065|E1|Reported Event|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
398495|NCT00624052|B5|Baseline|Total|Total of all reporting groups
398496|NCT00624052|B4|Baseline|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398497|NCT00624052|B3|Baseline|Titrated Telmisartan 80mg and Amlodipine 10mg|
398498|NCT00624052|B2|Baseline|Randomised Telmisartan 80mg and Amlodipine 10mg|
398499|NCT00624052|B1|Baseline|Telmisartan 40mg and Amlodipine 10mg|
398500|NCT00624052|P4|Participant Flow|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
398501|NCT00624052|P3|Participant Flow|Titrated Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
398502|NCT00624052|P2|Participant Flow|Randomised Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
398503|NCT00624052|P1|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
398504|NCT00624052|O3|Outcome|Pre-titration: Total|
398505|NCT00624052|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
398506|NCT00624052|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
398507|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398508|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398509|NCT00624052|O3|Outcome|Pre-antihypertensive: Total|
398510|NCT00624052|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
398511|NCT00624052|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
398512|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398513|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398514|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398515|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398516|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398517|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398518|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398519|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398520|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398521|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398522|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398523|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398524|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398525|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398526|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398527|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
398528|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
398529|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
398530|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
398549|NCT00624052|E2|Reported Event|Telmisartan 80mg and Amlodipine 10mg|The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
398550|NCT00624052|E1|Reported Event|Telmisartan 40mg and Amlodipine 10mg|The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants
398551|NCT00623974|B5|Baseline|Total|Total of all reporting groups
398552|NCT00623974|B4|Baseline|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398553|NCT00623974|B3|Baseline|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398554|NCT00623974|B2|Baseline|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398555|NCT00623974|B1|Baseline|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398556|NCT00623974|P4|Participant Flow|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398557|NCT00623974|P3|Participant Flow|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398558|NCT00623974|P2|Participant Flow|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398559|NCT00623974|P1|Participant Flow|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398560|NCT00623974|O4|Outcome|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398561|NCT00623974|O3|Outcome|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398562|NCT00623974|O2|Outcome|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398563|NCT00623974|O1|Outcome|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398564|NCT00623974|E4|Reported Event|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398565|NCT00623974|E3|Reported Event|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398566|NCT00623974|E2|Reported Event|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398567|NCT00623974|E1|Reported Event|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
398568|NCT00623935|B1|Baseline|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
398569|NCT00623935|P1|Participant Flow|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
398570|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
398571|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
398572|NCT00623935|E1|Reported Event|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
398573|NCT00623831|B3|Baseline|Total|Total of all reporting groups
398574|NCT00623831|B2|Baseline|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
398575|NCT00623831|B1|Baseline|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398576|NCT00623831|P2|Participant Flow|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
398577|NCT00623831|P1|Participant Flow|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a dose-limiting toxicity (DLT) until the desired pyrogenic effect was observed.
398578|NCT00623831|O2|Outcome|Cohort 2 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
398720|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398579|NCT00623831|O1|Outcome|Cohort 1 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398580|NCT00623831|O1|Outcome|Cohort 1 (Immune Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398581|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398582|NCT00623831|O2|Outcome|Cohort 2 (Safety Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
398583|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398584|NCT00623831|E2|Reported Event|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
398585|NCT00623831|E1|Reported Event|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
398586|NCT00623805|B3|Baseline|Total|Total of all reporting groups
398587|NCT00623805|B2|Baseline|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398588|NCT00623805|B1|Baseline|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398589|NCT00623805|P2|Participant Flow|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398590|NCT00623805|P1|Participant Flow|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398591|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398592|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398593|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398594|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398595|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398596|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398597|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398598|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398936|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398599|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398600|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398601|NCT00623805|E2|Reported Event|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398602|NCT00623805|E1|Reported Event|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
398603|NCT00623779|B4|Baseline|Total|Total of all reporting groups
398604|NCT00623779|B3|Baseline|Standard Therapy|Standard Therapy
398605|NCT00623779|B2|Baseline|AZD0837 300 mg|AZD0837 300 mg
398606|NCT00623779|B1|Baseline|AZD0837 150 mg|AZD0837 150 mg
398607|NCT00623779|P3|Participant Flow|Standard Therapy|Standard Therapy
398608|NCT00623779|P2|Participant Flow|AZD0837 300 mg|AZD0837 300 mg
398609|NCT00623779|P1|Participant Flow|AZD0837 150 mg|AZD0837 150 mg
398610|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398611|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398612|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398613|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398614|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398615|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398616|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398617|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398618|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398619|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398620|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398621|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398622|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398623|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398624|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398625|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398626|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398627|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398628|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398629|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398630|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398631|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398632|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398633|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398634|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398635|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398636|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398637|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398638|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398639|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398640|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398641|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398642|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398643|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398644|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398645|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398646|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398647|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398648|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398649|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
398650|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
398651|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
398652|NCT00623779|E3|Reported Event|Standard Therapy|Standard Therapy
398653|NCT00623779|E2|Reported Event|AZD0837 300 mg|AZD0837 300 mg
398654|NCT00623779|E1|Reported Event|AZD0837 150 mg|AZD0837 150 mg
398655|NCT00623766|B3|Baseline|Total|Total of all reporting groups
398656|NCT00623766|B2|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398657|NCT00623766|B1|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398937|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398658|NCT00623766|P2|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398659|NCT00623766|P1|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398660|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398661|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients|"Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.~Ipilimumab: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance"
398662|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398663|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398664|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398665|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398666|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398667|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398668|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398669|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398670|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398671|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398672|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398673|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398674|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398675|NCT00623766|O1|Outcome|Ipilimumab 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398676|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398677|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398678|NCT00623766|E2|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398679|NCT00623766|E1|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
398680|NCT00623727|B3|Baseline|Total|Total of all reporting groups
398681|NCT00623727|B2|Baseline|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398682|NCT00623727|B1|Baseline|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398683|NCT00623727|P2|Participant Flow|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398684|NCT00623727|P1|Participant Flow|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398685|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398686|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398687|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398688|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398689|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398690|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398691|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398692|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398693|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398694|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398695|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398696|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398697|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398698|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
398699|NCT00623727|E4|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Extension|Reporting group 4 (RG4): Open Label Extension, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
398700|NCT00623727|E3|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Follow-up|Reporting group 3 (RG3): Open Label Follow-up, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398701|NCT00623727|E2|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Double Blind|Reporting group 2 (RG2): Double Blind Study, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
398702|NCT00623727|E1|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Double Blind|Reporting Group 1 (RG1): Double Blind Study, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
398703|NCT00623714|B1|Baseline|All Patients|All Randomized Patients
398704|NCT00623714|P2|Participant Flow|Fluticasone Then Placebo|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
398705|NCT00623714|P1|Participant Flow|Placebo Then Fluticasone|Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
398706|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
398707|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
398708|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
398709|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
398710|NCT00623714|E2|Reported Event|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
398711|NCT00623714|E1|Reported Event|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
398712|NCT00623636|B3|Baseline|Total|Total of all reporting groups
398713|NCT00623636|B2|Baseline|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398714|NCT00623636|B1|Baseline|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398715|NCT00623636|P2|Participant Flow|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398716|NCT00623636|P1|Participant Flow|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398717|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398718|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398719|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
399022|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
398721|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398722|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398723|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398724|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398725|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398726|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398727|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398728|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398729|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398730|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398731|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398732|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398733|NCT00623636|E3|Reported Event|Open-label MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398734|NCT00623636|E2|Reported Event|Double-blind MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
398735|NCT00623636|E1|Reported Event|Double-blind Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
398736|NCT00623597|B3|Baseline|Total|Total of all reporting groups
398737|NCT00623597|B2|Baseline|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398738|NCT00623597|B1|Baseline|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398739|NCT00623597|P2|Participant Flow|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398740|NCT00623597|P1|Participant Flow|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398741|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398742|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
403137|NCT00613379|P3|Participant Flow|Arm 3|PBO, one IV dose (N=10)
398743|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398744|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398745|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398746|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398747|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398748|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398749|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398750|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398751|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398752|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398753|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398754|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398755|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398756|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398757|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398758|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398759|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398760|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398761|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398762|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398763|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398764|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398765|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398766|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398767|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398768|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398769|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398770|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398771|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398772|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398773|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398774|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398775|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
403141|NCT00613379|O2|Outcome|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
398776|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398777|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398778|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398779|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398780|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398781|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398782|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398783|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398784|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398785|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398819|NCT00623506|E1|Reported Event|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398820|NCT00623480|B3|Baseline|Total|Total of all reporting groups
398821|NCT00623480|B2|Baseline|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
403142|NCT00613379|O1|Outcome|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
398786|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398787|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398788|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398789|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398790|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398791|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398792|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398793|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398794|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398795|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398822|NCT00623480|B1|Baseline|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398823|NCT00623480|P2|Participant Flow|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398796|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398797|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398798|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398799|NCT00623597|E3|Reported Event|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398800|NCT00623597|E2|Reported Event|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398801|NCT00623597|E1|Reported Event|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
398802|NCT00623545|B1|Baseline|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
398803|NCT00623545|P1|Participant Flow|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
398804|NCT00623545|O1|Outcome|Exenitide Treatment|
398805|NCT00623545|O1|Outcome|Exenitide Treatment|There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
398806|NCT00623545|E1|Reported Event|Single Arm Study of Exenatide Treatment|
398807|NCT00623506|B3|Baseline|Total|Total of all reporting groups
398808|NCT00623506|B2|Baseline|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
398809|NCT00623506|B1|Baseline|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398810|NCT00623506|P2|Participant Flow|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
398811|NCT00623506|P1|Participant Flow|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398812|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
398813|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398814|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
398815|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398816|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
398817|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
398818|NCT00623506|E2|Reported Event|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
403143|NCT00613379|E3|Reported Event|Arm 3|PBO, one IV dose (N=10)
398824|NCT00623480|P1|Participant Flow|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398825|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398826|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398827|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398828|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398829|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398830|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398831|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398832|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398833|NCT00623480|E2|Reported Event|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
398834|NCT00623480|E1|Reported Event|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
398835|NCT00623467|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398836|NCT00623467|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398837|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398838|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398839|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398840|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398841|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398842|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398843|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398844|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398845|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398846|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398847|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398848|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398877|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398849|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398850|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398851|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398852|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398853|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398854|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398855|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398856|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398857|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398858|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398859|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398860|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398861|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398862|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398863|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398864|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398865|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398866|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398867|NCT00623467|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398868|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398869|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398870|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398871|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398872|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398873|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398874|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398875|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398876|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398878|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398879|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398880|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398881|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398882|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398883|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398884|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398885|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398886|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398887|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398888|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398889|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398890|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398891|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398892|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398893|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398894|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398895|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398896|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398897|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
398898|NCT00623467|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
398899|NCT00623441|B1|Baseline|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
398900|NCT00623441|P1|Participant Flow|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
398901|NCT00623441|O1|Outcome|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
398902|NCT00623441|E1|Reported Event|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
398903|NCT00623428|B3|Baseline|Total|Total of all reporting groups
398904|NCT00623428|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398933|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398934|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
399023|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
398905|NCT00623428|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398906|NCT00623428|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398907|NCT00623428|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398908|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398909|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398910|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398911|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398912|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398913|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398914|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398915|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398916|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398935|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
399102|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
398917|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398918|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398919|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398920|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398921|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398922|NCT00623428|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
398923|NCT00623428|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
398924|NCT00623233|B1|Baseline|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398925|NCT00623233|P1|Participant Flow|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398926|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398927|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398928|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398929|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398930|NCT00623233|E1|Reported Event|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
398931|NCT00623194|B1|Baseline|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398932|NCT00623194|P1|Participant Flow|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
399103|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
398938|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398939|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398940|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398941|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398942|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398943|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398944|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398945|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398946|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398947|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398948|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398949|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398950|NCT00623194|E1|Reported Event|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
398951|NCT00623181|B3|Baseline|Total|Total of all reporting groups
398952|NCT00623181|B2|Baseline|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
398953|NCT00623181|B1|Baseline|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
398954|NCT00623181|P2|Participant Flow|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
398955|NCT00623181|P1|Participant Flow|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
398956|NCT00623181|O2|Outcome|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
398957|NCT00623181|O1|Outcome|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
398958|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
398959|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
398960|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
398961|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.
398962|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
398963|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
398964|NCT00623181|E2|Reported Event|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
398965|NCT00623181|E1|Reported Event|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
398966|NCT00623103|B3|Baseline|Total|Total of all reporting groups
398967|NCT00623103|B2|Baseline|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398968|NCT00623103|B1|Baseline|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398969|NCT00623103|P2|Participant Flow|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
399024|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
399104|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
398970|NCT00623103|P1|Participant Flow|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398971|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398972|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398973|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398974|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398975|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398976|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398977|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398978|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398979|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398980|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398981|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398982|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398983|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398984|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398985|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
398986|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
398987|NCT00623103|E2|Reported Event|Exelon Patch|Exelon Patch
398988|NCT00623103|E1|Reported Event|Exelon Capsule|Exelon Capsule
398989|NCT00623012|B1|Baseline|Rapamycin Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
399025|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
399026|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
399027|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
398990|NCT00623012|P1|Participant Flow|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
398991|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
398992|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
398993|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
398994|NCT00623012|E1|Reported Event|Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
398995|NCT00622908|B3|Baseline|Total|Total of all reporting groups
398996|NCT00622908|B2|Baseline|Vehicle|Vehicle of ISV-403
398997|NCT00622908|B1|Baseline|ISV-403|0.6% ISV-403
398998|NCT00622908|P2|Participant Flow|Vehicle|Vehicle of ISV-403
398999|NCT00622908|P1|Participant Flow|ISV-403|0.6% ISV-403
399000|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
399001|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
399002|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
399003|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
399004|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
399005|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
399006|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
399007|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
399008|NCT00622908|E2|Reported Event|Vehicle|Vehicle of ISV-403
399009|NCT00622908|E1|Reported Event|ISV-403|0.6% ISV-403
399010|NCT00622869|B4|Baseline|Total|Total of all reporting groups
399011|NCT00622869|B3|Baseline|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
399012|NCT00622869|B2|Baseline|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
399013|NCT00622869|B1|Baseline|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
399014|NCT00622869|P3|Participant Flow|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
399015|NCT00622869|P2|Participant Flow|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
399016|NCT00622869|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
399017|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
399018|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
399019|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
399020|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
399021|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
399031|NCT00622869|E1|Reported Event|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids
399032|NCT00622739|B3|Baseline|Total|Total of all reporting groups
399033|NCT00622739|B2|Baseline|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399034|NCT00622739|B1|Baseline|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399035|NCT00622739|P2|Participant Flow|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399036|NCT00622739|P1|Participant Flow|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399037|NCT00622739|O2|Outcome|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399038|NCT00622739|O1|Outcome|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399039|NCT00622739|E2|Reported Event|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399040|NCT00622739|E1|Reported Event|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
399041|NCT00622726|B3|Baseline|Total|Total of all reporting groups
399042|NCT00622726|B2|Baseline|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
399043|NCT00622726|B1|Baseline|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
399044|NCT00622726|P2|Participant Flow|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
399045|NCT00622726|P1|Participant Flow|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
399046|NCT00622726|O4|Outcome|Conventional Laser-Control Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
399047|NCT00622726|O3|Outcome|Bevacizumab Experimental Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.
399048|NCT00622726|O2|Outcome|Conventional Laser-Control Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
399049|NCT00622726|O1|Outcome|Bevacizumab-Experimental Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
399050|NCT00622726|O2|Outcome|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.
399051|NCT00622726|O1|Outcome|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.
399052|NCT00622726|E2|Reported Event|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
399053|NCT00622726|E1|Reported Event|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
399054|NCT00622713|B1|Baseline|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399105|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399106|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399107|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399055|NCT00622713|P1|Participant Flow|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399056|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399057|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399058|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399059|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399060|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399061|NCT00622713|E1|Reported Event|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
399062|NCT00622700|B4|Baseline|Total|Total of all reporting groups
399063|NCT00622700|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399064|NCT00622700|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399065|NCT00622700|B1|Baseline|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399066|NCT00622700|P3|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399067|NCT00622700|P2|Participant Flow|Teriflunomide 7 Milligram (mg)|Teriflunomide 7 mg tablet once daily orally.
399068|NCT00622700|P1|Participant Flow|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399069|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399070|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399071|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399072|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399073|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399074|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399075|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399076|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399077|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399078|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399079|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399080|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399081|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399082|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399083|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399084|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399085|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399086|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399087|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399088|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399089|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399090|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399091|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399092|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399093|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399094|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399095|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399096|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399097|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399098|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399099|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399110|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399111|NCT00622700|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
399112|NCT00622700|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
399113|NCT00622700|E1|Reported Event|Placebo|Placebo matched to teriflunomide tablet once daily orally.
399114|NCT00622635|B1|Baseline|Entire Study Population|The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399115|NCT00622635|P6|Participant Flow|Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399116|NCT00622635|P5|Participant Flow|Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399117|NCT00622635|P4|Participant Flow|Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399118|NCT00622635|P3|Participant Flow|Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399119|NCT00622635|P2|Participant Flow|Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399120|NCT00622635|P1|Participant Flow|Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399121|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399122|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399123|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399124|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399125|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399126|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399127|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399128|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399129|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399130|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399131|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399132|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399133|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399134|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399135|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399136|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399137|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399138|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399139|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399140|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399141|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399142|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399143|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 